National Organic Standards Board | April 2016| Proposals & Discussion Documents

TOC

National Organic Standards Board Meeting

Omni Shoreham Hotel, Washington, DC - Blue Room

April 25-27, 2016

Title Page

Materials Subcommittee (MS) | Lisa de Lima, Chairperson 

Proposal: Excluded methods terminology 1

Discussion document: Excluded methods terminology 13

Discussion document: Seed purity - next steps 19

Livestock Subcommittee (LS) | Ashley Swaffar, Chairperson 

Proposal: Hypochlorous acid - petitioned 27

Proposal: Annotation changes for lidocaine and procaine 33

Proposal: Annotation change for parasiticides 37

Policy Development (PDS) | Tom Chapman, Chairperson

Proposal: Policy and procedure manual (PPM) revisions 51

Discussion document: Sunset timeline reorganization 201

Compliance, Accreditation, & Certification Subcommittee (CACS) | Carmela Beck, Chairperson

Verbal Update: Assessment of soil conservation practices No doc

Handling Subcommittee (HS) | Harold Austin, Chairperson

2018 Sunset Materials: Agar-agar, Animal enzymes, Calcium sulfate-mined, 

Carrageenan, Glucono delta-lactone, Tartaric acid, Cellulose, Potassium hydroxide, 

Silicon dioxide, Colors: Beta-carotene extract

215

Proposal: Sodium & Potassium lactate - petitioned 235

Proposal: Oat beta-glucan - petitioned 241

Proposal: Hypochlorous acid - petitioned 247

Proposal: Sodium dodecylbenzene sulfonate (SDBS) - petitioned 255
TOC

Proposal: Ancillary substances for microorganisms 263

Discussion document: Nutrient vitamins and minerals - annotation change 267

Crops Subcommittee (CS) | Zea Sonnabend, Chairperson 

2018 Sunset Substances: Copper sulfate, Ozone gas, Peracetic acid, EPA List 3 -

Inerts of unknown toxicity, Calcium chloride

271

Proposal: Ash from manure burning – petitioned 279

Proposal: Squid and squid byproducts - petitioned 283

Proposal: Hypochlorous acid - petitioned 289

Proposal: Soy wax - petitioned 297

Discussion document: Prohibition of nonyl phenol ethoxylates (NPEs) in inerts

annotation change

301

Verbal update: Inerts working group No Doc
National Organic Standards Board 

Materials/GMO Subcommittee 

Excluded Methods Terminology – Proposal 

February 23, 2016

Introduction and Background

In April 2013 the project was started to grapple with the definition of "excluded methods" in 

the USDA organic regulations. This is the definition that appears in the rule (7 CFR 205.2; Terms 

Defined):

Excluded methods. 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. (Federal Register / Vol. 

65, No. 246 / Thursday, December 21, 2000 / Rules and Regulations p. 80639)

The definition was based on the best efforts of the NOSB in 1995 and has provided adequate 

guidance to prohibit the use of the most obvious genetically engineered crops such as 

herbicide-resistant corn and soybeans and Bt cotton, as well as prohibit processing inputs such 

as genetically engineered yeasts and enzymes. However, this definition is in need of reexamination and updating due to rapid advances in recombinant DNA biotechnology since 1995 

that have made for gray areas for the organic standards regarding interpretation and 

enforcement.

In 2011 and 2012 a number of confusing issues came before the NOSB and to the NOP which 

made it necessary to revisit the definition. These include genetically engineered vaccines for 

livestock, the use of cell fusion within plant families to create male sterility in brassica hybrids, 

whether or not GMOs could be used in biodegradable bioplastic mulches, and the question of 

whether mutated algae might therefore be genetically engineered. The current definition is 

inadequate to clarify these issues. In the last few years the rise of gene editing with no insertion 

of foreign DNA, synthetic biology, and the genetically engineered insects that are starting to 

appear make this effort even more important.

The first NOSB Discussion Document on excluded methods in 2013,1 discussed each of the 

terms in the above definition, defined and discussed other terms involved in traditional 

breeding, such as mutagenesis and conjugation, and brought up new terms that may be 

considered to be genetic engineering. No conclusions were suggested except that there is a 

need to do more work on the subject. The discussion questions posed asked commenters to 

suggest principles on which to base GE distinctions, to offer opinions on what terms were and 

were not excluded methods, and to bring forward new terms that may need consideration. 

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The second NOSB Discussion Document posted in September, 2014 and in April 20152 analyzed 

the comments received and proposed several options for an updated definition, and principles 

and criteria to use when evaluating the various genetic modification issues. Additional terms 

were collected and the beginnings of some definitions were started. A structure was proposed 

similar to the one in use by FiBL in Europe that involves an itemized chart with a yes/no column 

where the specific techniques could be itemized and evaluated. A recommendation was 

informally made by the subcommittee, but not voted upon, that these revisions to the 

definition and structure for evaluating techniques be regulated through NOP guidance rather 

than additional rulemaking. Lastly it was acknowledged that there will be some unresolved 

issues that will need continued public discussion because they pose enforcement challenges, 

are totally hidden from view, or not enough is known about them yet.

Goals of This Proposal/Document

The need for forward motion on this subject is more pressing every month. The fact that over 

1000 pages of scientific references were submitted in public comment, with most of it being 

papers that came out since the NOSB GMO ad hoc Subcommittee was formed in 2012, indicates 

that the biotech community is rapidly outpacing any regulatory structure. The U.S. Department 

of Agriculture (USDA) has already ruled that certain plants produced with novel approaches to 

genetic manipulation will not be regulated as genetically modified organisms in the United 

States3. It is more imperative than ever that the organic community be very clear about where 

the line is drawn regarding genetic engineering.

Public Comment from the past two years has indicated strong support for this effort on the 

whole, although there is not consensus on some details. Every organic stakeholder is clear that 

genetic engineering is an imminent threat to organic integrity. Every effort must be made to 

protect that integrity to the extent that the NOSB is able to contribute to that.

The Materials Subcommittee is ready to move forward to create a structure for reviewing new 

technologies and disseminating the results of this review in a transparent manner. To this end, 

the proposal portion of this document includes supplements to the definition in the rule based 

on internationally accepted language, criteria to use in the reviews based on that definition, 

and a chart of those techniques that are clearly "excluded methods" based on the definition 

and criteria.

A separate discussion document contains the technologies, terms, and issues that we have not 

been able to agree on or do not yet have enough information on or that pose challenges that 

we have not yet taken up. These items are put out for discussion to collect further public 

comment. They will be reviewed at future NOSB meetings.

Definitions 

In the previous Discussion Document we suggested a couple of possible definitions that would 

update the text in the rule to a more comprehensive one that would be flexible enough to 

accommodate future technologies and terms. We were inclined to favor the definitions in use 

by the Cartagena Protocol that are also in use by Codex Alimentarius. 

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During the course of public comment and subsequently, it has become clear that more than 

one definition is important to the organic community, but that all the terms we suggest 

defining here would fall under the Excluded Methods definition in the rule and would not 

change, but would strengthen that definition. These definitions are to be used in Guidance to 

supplement and update the definition in the regulations, while leaving the rule itself intact. It is 

important to adopt some definitions that are widely accepted internationally and thus give 

some common ground with other countries who are concerned about GMOs in organics.

In October 2015 the International Federation of Organic Agriculture Movements (IFOAM) put 

out a Discussion Paper on a proposed revision to their Position on Genetic Engineering.45 Since 

they do not use the concept of "Excluded Methods" in other countries, they proposed new 

definitions for three terms: Genetic Engineering (GE), Genetically Modified Organism (GMO), 

and Synthetic Biology. After examining their definitions, the Materials/GMO Subcommittee 

(MS) agrees that these three terms are important to define in the guidance we are proposing. 

However, we do not wish to take the old approach (that IFOAM is still using) of trying to 

capture all the methods and terms into one definition, because it will be out of date as soon as 

the next round of new technologies arrives.

Therefore we are suggesting the following definitions of terms and acronyms, with sources, be 

adopted by the NOSB as being Excluded Methods: 

Genetic engineering (GE) – A set of techniques from molecular biology (such as recombinant 

DNA and RNA) by which the genetic material of plants, animals, micro-organisms, cells and 

other biological units are altered and recombined (first sentence modified from IFOAM Position 

cited above)

Genetically Modified Organism (GMO) – A plant, animal, or microorganism that is transformed 

by genetic engineering as defined here. This term will also apply to products and derivatives 

from genetically engineered sources (first sentence from IFOAM Position cited above, second 

sentence modified from their definition)

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 conventional breeding and selection. (From the Cartagena 

Protocol6 and also used by Codex Alimentarius)

Non-GMO – The term that is used to describe or label a product that was produced without any 

of the excluded methods defined here. It is consistent with the NOP process-based standard 

that does not imply freedom from GMOs but does indicate that processes to prevent GMO 

contamination have been used (from the public comment by the Organic Trade Association, 

April 20157) 

Synthetic Biology8 – A further development and new dimension of modern biotechnology that 

combines science, technology and engineering to facilitate and accelerate the understanding, 

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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 Diversity9) 

This series of definitions provide a better framework than solely the existing definition to 

further elaborate the various technologies that would be prohibited as well as those which 

would be allowed. We propose to combine these definitions, the principles and criteria 

discussed below, and the Terminology chart presented into this Proposal for Guidance on 

Excluded Methods.

Principles and Criteria

The NOSB has its own set of Principles of Organic Production and Handling in the Policy and 

Procedures Manual10. They start with:

1.1 Organic agriculture is an ecological production management system that promotes 

and enhances biodiversity, biological cycles, and soil biological activity. It emphasizes 

the use of management practices in preference to the use of off-farm inputs, taking into 

account that regional conditions require locally adapted systems. These goals are met, 

where possible, through the use of cultural, biological, and mechanical methods, as 

opposed to using synthetic materials to fulfill specific functions within the system.

One of the points following this is in regard to Genetic Engineering:

1.11 Genetic engineering (recombinant and technology) is a synthetic process designed 

to control nature at the molecular level, with the potential for unforeseen 

consequences. As such, it is not compatible with the principles of organic agriculture 

(either production or handling). Genetically engineered/modified organisms 

(geo/gmo’s) and products produced by or through the use of genetic engineering are 

prohibited.

The following principals of Organic Agriculture are used by IFOAM11 and summarize well the 

guidance for developing a position on GMO technology.

• Principle of Health: Organic Agriculture should sustain and enhance the health of soil, 

plant, animal, human and planet as one and indivisible.

• Principle of Ecology: Organic Agriculture should be based on living ecological systems 

and cycles, work with them, emulate them and help sustain them.

• Principle of Fairness: Organic Agriculture should build on relationships that ensure 

fairness with regard to the common environment and life opportunities.

• Principle of Care: Organic Agriculture should be managed in a precautionary and 

responsible manner to protect the health and well-being of current and future 

generations and the environment.

Using the principles above, biotechnology processes will be reviewed to the following criteria to 

determine if they are excluded methods: 

• The genome is respected as an indivisible entity and technical/physical invasion into the 

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plant genome is refrained from (e.g. through transmission of isolated DNA, RNA, or 

proteins). In vitro nucleic acid techniques are considered to be invasion into the plant 

genome.

• The ability of a variety to reproduce in species-specific manner has to be maintained and 

technologies that restrict the germination capacity of seed-propagated crops are 

refrained from (e.g. Terminator technology).12

• Novel proteins must be prevented from being introduced into the soil and water 

ecosystems and into the organic food supply.

• The exchange of genetic resources is encouraged and any patenting of living organisms, 

their metabolites, gene sequences or breeding processes are refrained from.13

Most of the techniques that are considered to be genetic engineering are clearly not 

compatible with the principal of ecology because they do not work within living ecological 

systems or sustain them. They are also at odds with the Principal of Fairness because they are 

not available equally to all stakeholders and are often patented or used to create patented 

traits. There are significant questions around the Principle of care for the health and well-being 

of future generations and the environment. These concerns do not change just because a 

technique cannot be tested for or does not use DNA foreign to the target organism.

The secondary effects from the use of GMOs are starting to emerge clearly in parallel with the 

new technologies. Issues such as reduction in diversity on farms where GMOs are grown, the 

demise of beneficial species both above and below the soil, the decline in soil fertility and 

resilience from increased use of herbicides, the evolution of weeds resistant to those herbicides, 

the altered nutritional profiles of the GMO crop products, and the displacement of small 

farmers from their land are all violations of the principals of organic agriculture.14

In the accompanying discussion document there will be additional discussion of how these 

concepts might be used in organic plant breeding.

Process and Product

Since the whole underpinning of the U.S. organic regulations is a process-based system, it 

makes sense that this concept carry over to defining excluded methods. This is indeed the basis 

of the current definition. However, this is not currently how U.S. government agencies regulate 

GMOs15, or handle other issues such as pesticide residues or water quality standards. 

Newer technologies, known as Targeted genetic modification (TagMo) or targeted genome 

editing, are emerging and being adopted quickly.16 These are very clearly genetic engineering 

techniques but are not regulated by the current government structure because they do not 

involve DNA from a "pest" under the USDA APHIS regulatory structure. Many of these 

techniques involve precise changes in existing DNA without using foreign DNA from a different 

species. These new technologies make genetic modification much more accessible and less 

expensive. The resulting plants may not show up as genetically engineered in the commonly 

used testing methods because they contain no foreign DNA, just native DNA that has been 

changed at the allele level by humans. 

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Forward Movement towards Structure

FiBL Research Institute for Organic Agriculture from Switzerland submitted a comment in 2013 

that included a chart that describes methods with a yes/no column for compatibility with 

organic standards for both plants and animals17. The NOSB posed adopting such a chart on the 

methods that receive consensus and can be incorporated into guidance. It is important to 

identify all of these terms so that it is clear that they fall under the definition of excluded 

methods, but these terms do not need to be added to the definition itself.

The first version of such a chart for the NOSB is presented here. Appendix A provides a brief 

description of each term with additional citations for those who want to find out more about 

the terms. There is so much terminology and so many techniques with similar or multiple 

names that we have added a column for additional names and types used for each general 

process. Along with lack of regulation of some of these processes, there is lack of 

standardization of the terms, so that new names and sometime proprietary ones are emerging 

all the time.

We would especially like to acknowledge the work done by the Center for Food Safety in their 

public comment for the April 2015 meeting. They have helped organize all the various 

terminology and provided substantial scientific papers that discuss all the terms.18 The 

technologies are grouped by the tasks that the methods accomplish and the types of changes 

made to the engineered organism. In the context of this proposal we are not able to discuss 

most of the terms at length so please see the Appendix and the CFS cited comment for the full 

reference list.

The ones marked "TBD" in the chart below are discussed further in the accompanying 

Discussion Document.

Terminology Chart

Method and synonyms Types Excluded 

Methods

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*

TALENs**

Oligonucleotide directed 

mutagenesis (ODM)

Rapid Trait Development System 

(RTDS) (Cibus)

YES Most of these new 

techniques are 

not regulated by 

USDA and are 

hard to test for.

Gene Silencing RNA-dependent DNA 

methylation (RdDM)

Silencing via RNAi pathway

RNAi pesticides

YES

Accelerated plant breeding Reverse Breeding YES These may pose 

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techniques Genome Elimination

FasTrack

Fast flowering

Dupont Seed Production 

Technology (SPT)

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

Embryo transfer in animals Embryo rescue in animals YES FiBL distinguishes 

embryo rescue in 

plants from 

animals.

Cloned animals and offspring Somatic nuclear transfer YES

Plastid Transformation YES

Marker Assisted Selection NO

Protoplast Fusion TBD

Cisgenesis TBD

Intragenesis TBD

Transposons TBD

Transduction TBD

Cell Fusion within Plant Family TBD

Embryo rescue in plants TBD

TILLING Eco-TILLING TBD

Agro-infiltration TBD

Doubled Haploid Technology TBD

Induced Mutagenesis TBD

* CRISPR-Cas = Clustered regularly interspaced short palindromic repeats and associated protein genes.

** TALENs = Transcription activator-like effector nucleases.

Proposal

This proposal has three sections, to be used in NOP Guidance on Excluded Methods: 

1. Approve the definitions of Genetic Engineering (GE), Genetically Modified Organism (GMO), 

 Modern Biotechnology, Non-GMO, and Synthetic Biology as written above.

2. Approve the Principles and Criteria above that will be used in the evaluation of new 

 technologies and terminologies.

3. Adopt the Terminology chart proposed above and the listings in it as presented, recognizing 

 that this will be added to as further deliberations occur in the future.

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Subcommittee Vote

The NOSB Materials/GMO subcommittee approves the three sections of this proposal as stated 

above.

Motion by: Zea Sonnabend 

Second: Tracy Favre

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

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Appendix A – 

Brief Description and Additional Citations for Terms used in Excluded Methods Terminology 

Chart. 

Only terms that are marked YES or NO as Excluded Methods are defined here. All those marked 

TBD are still being worked on in discussion. Those marked "syn." are defined in cited reference

from Center for Food Safety Public Comment in April 201519. Some other definitions are from 

the NOSB previous Discussion Document20 and from the FiBL 2015 plant breeding dossier.21

Targeted genetic modification (TaqMo) (Kuzma and Kokotovich 2011, Kokotovich and Kuzma 

2014) - a collective term for the zinc finger nuclease techniques that create DNA doublestranded breaks at specific genomic locations that can then be used to alter the target 

gene. The genetic modification would not necessarily involve transfer of nucleic acids 

from another species, nor would it be easy to detect in a final product. 

• syn. Synthetic gene technologies (Then 2015) 

• syn. Genome engineering (Voytas and Gao 2014)

• syn. Gene editing (Puchta and Fauser 2013) 

• syn. Gene targeting (GT) (Puchta and Fauser 2013, Endo et al. 2015)

• syn. Sequence-specific nucleases (SSNs) (Voytas and Gao 2014): 

• syn. Meganucleases (Gao et al. 2011, as cited in FSANZ 2013) 

• syn. Site directed mutagenesis via oligonucleotides, zinc finger nuclease (ZFN) (Dow, 

APHIS 2012) - an introduction of recombinant DNA through transient molecules that 

are identified by zinc-finger nucleases, with or without a repair template. The 

techniques resemble transgenesis but the end products are similar to, and 

indistinguishable from, conventionally bred plants.

• syn. Clustered regularly interspaced short palindromic repeats and associated 

protein genes (CRISPR-Cas system) (NYTs 3/20/2015) – a protein called Cas9 enables 

breaks in DNA at specific spots so that additional pieces of DNA and RNA can be 

inserted.

• syn. Transcription activator-like effector nucleases (TALENs) (Sprink et al. 2014).

• syn. Oligonucleotide directed mutagenesis (ODM) (Lusser et al. 2011)

• syn. Cibus Rapid Trait Development System (RTDS) (Beetham et al. 2012 patent) - 

Similar to the oligonucleotide targeted DNA modification it does not leave behind 

transgenic material, only uses it to create a change in a precise area of a gene.

Gene silencing via RNAi and DNA methylation - Interfering with the regulation of gene 

expression through inserting methyl groups onto RNA and DNA that then supress the 

expression of the gene. Can occur in nature, but is used as a recombinant technique in 

cancer research and plant breeding.

• syn. RNA-dependent DNA methylation (RdDM) (Lusser et al. 2011)

• syn. Gene silencing via RNAi pathway (Casacuberta et al. 2015, Baier et al. 2014, Lubasik 

and Zielenkiewicz 2014, Hirschi 2012, Heinemann et al. 2013, Lundgren and Duan 2013, 

Wagner et al. 2015) – A technique in which a small strand of RNA is inserted into a DNA 

sequence to regulate the expression of the gene. There is no change to the DNA 

sequence, but there is technical interference with the genome.

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• RNAi-based pesticides (Palli 2014, Zhu 2013) – RNA interference (RNAi) is a technique in 

which gene silencing RNA strands are inserted into a target genome in order to regulate 

the expression of target genes. It was used to engineer rootworm resistant corn as well 

as to genetically engineer insects themselves.

Accelerated Plant Breeding Techniques

• Reverse Breeding (Dirks et al. 2009) – A process that uses several other techniques such 

as RNAi to suppress meiotic recombination, tissue culture, and then double 

haploidization to create parental lines that are homozygous to use in breeding F1 

hybrids.

• Genome elimination (Comai 2014)

• FasTrack (Waltz 2012) – a breeding scheme that has so far been used in plums where an 

early-flowering gene from poplar is inserted into a plum tree. When the plum flowers in 

less than a year, it is crossed with non-transgenic varieties carrying desirable traits. 

Markers are used to identify the right traits and, at the end of the breeding program, 

only those are selected that do not have the transgene.

• Fast flowering (Flachowsky et al. 2011)

• DuPont’s Seed Production Technology (SPT) (Waltz 2012)

Synthetic Biology (see definition in main document)

• Synthetic chromosomes (Shenoy and Sarma 2010, pp. 12-13; Gaeta et al. 2012)

Embryo Transfer in animals – a technique used in animal breeding. It involves inducing 

superovulation of donor with gonadotropins, artificial insemination, recovery of 

embryos, isolation and storage of embryos, transfer of embryos back into animals, and 

then pregnancy.

Plastid transformation (Maliga 2004, as cited in NOSB discussion 2014) – Plastids are semiautonomous organelles within higher plants with a small, highly polyploid genome. 

Technology has been developed for genetic modification of this genome independent of 

nuclear DNA. Currently used commercially in tobacco, and widely researched.

Marker Assisted Selection – Molecular markers are used as diagnostic aids to determine 

differences in the DNA sequence. They can help in selecting desired traits. The markers 

do not change the DNA of living plants and are not considered to be genetic engineering.

1 NOSB 2013. Excluded Methods Terminology Discussion Document. April 2013. 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5102656

2 National Organic Standards Board Materials/GMO Subcommittee. (2014). Discussion Document on Excluded 

Methods Terminology. August 22.

3 Waltz, E. (2012). Tiptoeing around transgenics. Nature Biotechnology, 30, 215-217. doi:10.1038/nbt.2143 4

 IFOAM – Organics International, 2015, 2015 Discussion Paper on a Proposed Revision to Position on Genetic 

Engineering and Genetically Modified Organisms in Organic Agriculture. 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/Discussion_paper_on_GMO_position_2015.pdf 

5

 IFOAM – Organics International, 2002, Position on Genetic Engineering and Genetically Modified Organisms, P01, 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/IFOAM_GMO_Position_Paper.pdf

6 Convention on Biological Diversity. 2013. The Cartagena Protocol on Biosafety. Available at: 

http://bch.cbd.int/protocol. 7 Organic Trade Association Comments to the NOSB, http://www.regulations.gov/#!documentDetail;D=AMS-NOP15-0002-0814

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8 Two other definitions were looked at when this one was chosen: Synthetic Biology – Designing and constructing 

biological devices, biological systems, biological machines and biological organisms using a range of methods 

derived from molecular biology and biotechnology, including in virtually all cases the techniques of genetic 

engineering or genetic modification (from IFOAM Position cited above). Synthetic biology is a maturing scientific 

discipline that combines science and engineering in order to design and build novel biological functions and 

systems. This includes the design and construction of new biological parts, devices, and systems, as well as the redesign of existing, natural biological systems for useful purposes.” (from SynBerc, the University of 

California/Department of Energy synthetic biology research consortium) 9 Link to the European Commission's draft definition with discussion: 

http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_21_e

n.htm

10 NOSB Policy and Procedures Manual: https://www.ams.usda.gov/sites/default/files/media/NOSBPolicyManual.pdfhttps://www.ams.usda.gov/sites/default/files/media/NOSB-PolicyManual.pdf

11 http://www.ifoam.bio/sites/default/files/poa_english_web.pdf

12 FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070

13 FiBL Research Institute of Organic Agriculture 2015. Dossier No. 2 Plant Breeding Techniques: an assessment for 

organic farming.

14 IFOAM – Organics International, 2015, 2015 Discussion Paper on a Proposed Revision to Position on Genetic 

Engineering and Genetically Modified Organisms in Organic Agriculture. 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/Discussion_paper_on_GMO_position_2015.pdf 

15 Kuzma J, Kokotovich A (2011) Renegotiating GM crop regulation. EMBO reports 12: 883–888. 16 Kokotovich A, Kuzma J (2014) Conflicting Futures: Environmental Regulation of Plant Targeted Genetic 

Modification. Bulletin of Science, Technology & Society 34: 108–120. 17 FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070 18 CFS Comments to the NOSB, 2015, Docket #AMS_NOP_15-0002-0874

19 CFS Comments to the NOSB, 2015. Reference List. http://www.regulations.gov/#!documentDetail;D=AMS-NOP15-0002-0875

20 National Organic Standards Board Materials/GMO Subcommittee. (2014). Discussion Document on Excluded 

Methods Terminology. August 22. 21 FiBL Research Institute of Organic Agriculture 2015. Dossier No. 2 Plant Breeding Techniques: an assessment for 

organic farming.

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National Organic Standards Board 

Materials/GMO Subcommittee 

Excluded Methods Terminology – Third Discussion Document 

February 23, 2016

Introduction and Background

In April 2013 the project was started to grapple with the definition of "excluded methods" in 

the USDA organic regulations. This is the definition that appears in the rule (7 CFR 205.2; Terms 

Defined):

Excluded methods. 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. (Federal Register / Vol. 

65, No. 246 / Thursday, December 21, 2000 / Rules and Regulations p. 80639)

The definition was based on the best efforts of the NOSB in 1995 and has provided adequate 

guidance to prohibit the use of the most obvious genetically engineered crops such as 

herbicide-resistant corn and soybeans and Bt cotton, as well as prohibit processing inputs such 

as genetically engineered yeasts and enzymes. However, this definition is in need of reexamination and updating due to rapid advances in recombinant DNA biotechnology since 1995 

that have made for gray areas for the organic standards regarding interpretation and 

enforcement.

Please see the Excluded Methods Terminology Proposal from this same date for a full 

elaboration of the background and progress to this point.

This Discussion Document contains the technologies, terms, and issues that we have not been 

able to agree on or do not yet have enough information on or that pose challenges that we 

have not yet taken up. These items are put out for discussion to collect further public comment. 

They will be reviewed at future NOSB meetings.

Discussion 

There are several areas for future discussion and work on this subject:

• Additional criteria for evaluating technologies that need to be considered.

• How to detect those technologies that are excluded but may not provide detectable 

genetically engineered DNA when tested.

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• Enforcement of the excluded method provisions of the rule when they are not traceable 

and undetectable.

• Additional technologies and terms that may not be clearly prohibited as excluded 

methods.

• Whether the concepts adopted in the proposal should or could lead to Organic Plant 

Breeding standards and the regulation of the term "Organically Bred Variety (or 

Animal)"

Once the proposal section in the accompanying document is voted on the structure will be in 

place to continue looking at these issues. We are interested in input from the organic public on 

these issues and will continue to have a transparent process to keep excluded methods out of 

organic production.

A. Additional Criteria

In the 2015 publication on Plant Breeding from FiBLi

, the Research Institute for Organic 

Agriculture from Switzerland, there are several more criteria mentioned than we have adopted 

in our proposal. These include:

• The cell is respected as an indivisible functional entity and technical/physical invasion 

into an isolated cell on growth media is refrained from (e. g. digestion of the cell wall, 

destruction of the cell nucleus through cyto-plast fusions).

• A variety must be usable for further crop improvement and seed propagation. This 

means that the breeders’ exemption and the farmers’ right are legally granted and 

patenting is refrained from, and that the crossing ability is not restricted by technical 

means (e.g. by using male sterility without the possibility of restoration).

• The creation of genetic diversity takes place within the plant specific crossing barriers 

through fusion of egg cell and pollen. Forced hybridization of somatic cells (e.g. through 

cell fusions) is refrained from.

B. Detection and testing

Many in the organic community have proposed that there be some testing of at-risk seeds and 

crops for the presence of GMOs and a threshold beyond which the crop could not be sold as 

organic. Consumers throughout the world clearly want to know if their food has been 

genetically engineered. These tests are reliable indicators of DNA that has had foreign 

components introduced at the genome level.

However, in the newer gene splicing and gene editing technologies there is no foreign DNA 

introduced. The DNA in the genes has been moved around, or sequences introduced from 

within the same genome that change the expression of certain traits. Many if not most of these 

methods are not detectable with the existing tests for GMOs. While it is likely that such testing 

may be developed in the future, it becomes very challenging for the National Organic Program 

(NOP) and Accredited Certifying Agents (ACA) to determine if any new variety was produced 

with one of the newer excluded technologies.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 14/302
Ideas for addressing this have included creating a website for plant varieties that are excluded, 

or some sort of affidavit system for ACAs to use for varieties known to be introduced from 

these methods. Any workable ideas for accomplishing a way to tell which varieties are excluded 

are welcome.

C. Enforcement

Hand in hand with the above detection issue is the question of how to enforce the exclusion of 

new technologies when they cannot be detected. Enforcement needs to be equal across all 

ACAs and there has to be adequate training for ACAs in how to recognize newer strains of 

GMOs and what to do about them. The same process that could be developed for detection 

could also tie into enforcement, but some creative approaches are needed for these issues 

since they are not being addressed by the USDA as a whole.

D. Additional technologies and terms

The chart presented in the Proposal document has a number of terms that are marked "TBD" in 

the Excluded Methods column. These are the ones that need further discussion to determine 

which of these should be added to the chart and which may not be appropriately deemed and 

excluded method. Some may be excluded for some uses but not others depending on exactly 

how the technique is carried out. They are repeated below, with a few notes:

Terminology Chart

Method and synonyms Types Excluded 

Methods

Notes

Protoplast Fusion TBD There are many ways to achieve

protoplast fusion and until the 

criteria about cell wall integrity is 

discussed, these technologies 

cannot yet be evaluated.

Cisgenesis TBD A very broad term that may need 

to be divided into some allowed 

and some excluded techniques.

Intragenesis TBD Similar to cisgenesis but gene 

sequences may be re-arranged.

Transposons TBD Used in animal vaccines. May be 

excluded in some situations but not 

others.

Transduction TBD Most sources think not excluded, 

but more study needed.

Cell Fusion within Plant Family TBD Subject of an NOP memo in 2013, 

the issue of detection of these 

varieties needs to be addressed 

before further policies can be 

adopted.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 15/302
Embryo rescue in plants TBD Many sources including FiBL think 

this is not excluded but more study 

of the methods is needed.

TILLING Eco-TILLING TBD Stands for Targeted Induced Local 

Lesions In Genomes. It is a type of 

mutagenesis combined with a new 

screening procedure.

Agro-infiltration TBD In vitro nucleic acids are introduced

to plant leaves to be infiltrated into 

them. More study needed.

Doubled Haploid Technology TBD There are several ways to make 

double haploids and some do not 

involve genetic engineering but 

some do.

Induced Mutagenesis TBD This is a very broad term and needs 

to be divided and classified based 

on what induces the mutations, 

chemicals, radiation, or other 

stresses.

E. Organic Plant Breeding

Some groups in Europe are moving ahead with developing a full set of organic plant breeding 

standards. If this become regulation there, then a label could be given for an "Organically Bred 

Variety". This is far from being able to be achieved in the U.S.A. with a very different approach 

to seed regulations as a whole. However, it is a potential next step and may be appropriate to 

tie into the discussion of some of the remaining terms above. For more information about this 

see the FiBL dossier cited above.

For instance a variety created with a cell fusion event for brassica male sterility might be 

allowed as seed in organic farming (as it is now) but prohibited from being used in a variety 

labeled as "Organically Bred Variety" with an organic breeding standard.

Discussion Questions

1. Are there any additional criteria for evaluating technologies that need to be considered?

2. Do you have any insights on how to detect those technologies that are excluded but may not 

provide detectable genetically engineered DNA?

3. Please offer any suggestions for enforcement of the excluded method provisions of the rule 

when they are not traceable or detectable.

4. Opinions are welcome on the terms in the chart above that may or may not be clearly 

prohibited as excluded methods.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 16/302
Subcommittee Vote

Motion to adopt the third discussion document on Excluded Methods

Motion by: Zea Sonnabend 

Second: Emily Oakley

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

i i FiBL Research Institute of Organic Agriculture 2015. Dossier No. 2 Plant Breeding Techniques: an assessment for 

organic farming.

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National Organic Standards Board 

Materials/GMO Subcommittee 

Discussion Document on Next Steps for Improving Seed Purity

February 23, 2016

Introduction 

For several years now the National Organic Standards Board (NOSB) has been collecting public 

input on the issue of Seed Purity from GMOs. After two discussion documents, a report1, a 

collection of Prevention strategies to keep GMOs out, and an expert panel on seed purity, we 

are still not to the point of making a comprehensive proposal.

The obstacles are immense, and have been thoroughly vetted in our past posted documents. 

Suffice to say the obstacles are not shrinking with the passage of time, but the need for action 

is growing. This paper is a springboard to what are the next activities/recommendations/ 

policies that could be undertaken to move forward on this issue. Some of these ideas are 

brought forward here, while any other new approaches are also welcome.

Background

At the spring 2015 NOSB meeting the expert panel on Seed Purity addressed many of the 

challenges around adopting any testing protocol or threshold. The NOSB had proposed 

instituting a seed purity testing requirement for only non-organic seed of at risk crops as part of 

the overall prevention strategies. As a result of the Expert Panel Discussion, this section was 

withdrawn from the final proposal on prevention strategies because it was felt more work was 

needed. That language is provided as an Appendix to this paper.

There are a number of good reasons to require a seed purity declaration for non-organic seed, 

including:

• Provides incentive for growers to use organic seed.

• Shifts the burden of routine GMO testing from organic seed producers to suppliers of 

non-organic seed.

• Reduces the inadvertent introduction of GMOs into organic crops through seed.

• Fits in with the organic regulations to prohibit excluded methods by providing ACAs with 

a tangible method of verification.

We are mindful of this quote from Matthew Dillon, from Clif Bar & Company, in his testimony 

to the NOSB during the expert panel, "We often say that seed work is slow work. It takes seven, 

ten, twelve years to breed a new variety and get it into the commercial marketplace. 

Sometimes longer. Seed work is slow work and we have to be deliberate in our approach to 

seed, whether it's in breeding and production or in our decisions regarding regulations."2

1 Report on Seed Purity from GMOs 

https://www.ams.usda.gov/sites/default/files/media/materialstx.pdf 2 NOSB meeting transcript, Spring 2015, La Jolla, CA 

https://www.ams.usda.gov/sites/default/files/media/transcript.pdf

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 19/302
Themes from Public Comment

Several clear themes have emerged from both the public comment received from the past 

several years of discussions and the expert panel from the spring 2015 NOSB meeting. These 

are summarized below and should be used as a framework to be mindful of as we design the 

next steps.

1. We need more data. 

• Everyone agrees that contamination is occurring, but very little is known about how 

much comes from seed as opposed to pollen drift or co-mingling in harvest and cleaning. 

Without knowing a background level (or adventitious presence) in seed before planting, 

it is impossible to determine further sources that contribute to contamination.

• Although baby steps are being taken to enable more data to be collected, it is not 

enough or soon enough to tackle the problem of contamination. Most of the data now 

collected is proprietary to seed companies or grain buyers who do their own testing.

• It all starts with seeds and so this is a good place to start in data collecting activities.

• Seed companies could generate and provide some of their data if it was collected in a 

systematic way and if the organic seed guidance was strengthened.

2. The responsibility for genetic contamination should lie with the polluters.

• The organic movement worldwide believes that organic producers should not be 

penalized for the trespasses of others and genetic contamination is trespass.

• Organic seed producers are already overcoming great hurdles to produce seed, from 

limited genetic resources to all the extra prevention strategies they must use. Burdening 

them with extra costs of testing is penalizing them such that their viability is at stake.

• A realistic balance must be sought between the need to keep genetically engineered 

content out of organic production and the practicality of keeping an organic seed 

industry alive and viable.

• The NOSB is limited in scope to what can be achieved through the organic regulations. 

Making polluters accept responsibility is outside of that scope. Only by being proactive 

in keeping these issues in the public eye and communicating them to the Secretary, can 

the NOSB make a difference.

• A recommendation with this statement in it will not be able to be published by the NOP. 

In order to keep this message in circulation, the concept needs to be expressed as part 

of other more achievable language.

3. All crop species are not the same

• There may need to be separate requirements for the different at-risk crops, because the 

pollination, geographic, and economic differences result in large differences in how fast 

progress can be made away from GMO contamination.

• Soybeans, being largely self-pollinating, are already able to meet a fairly stringent 

threshold requirement.

• Cotton has only one or two commercial seed companies providing non-GE seed in the 

USA and one is threatened. There is only one public cotton breeder in the US. While 

many growers save their own seed, the cotton seed supply worldwide is under serious 

threat from GMOs but without access to clean varieties, this will not be able to change.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 20/302
• Canola production for organic has almost entirely left the U.S. because of GMO 

contamination.

• Corn has very limited availability of inbred parent lines that are not contaminated and 

the seed companies providing them often prohibit GMO testing in them. Therefore the 

genetic diversity available to organic seed companies is much lower and this crop is 

particularly at risk from lack of genetic diversity. Also the special skill set needed to 

produce organic hybrid corn is now resting with only about 20 growers in the US. Corn 

pollen can travel several kilometers and so contamination is extremely likely no matter 

what steps are taken to prevent it.

• One suggestion floated several times has been to exempt breeding lines grown in 

organic systems from the treated seed prohibition in the rule. Many of the breeding 

lines are only available with seed treatments. Since these lines are not used to produce 

a crop, but only to produce the seed that then needs to be increased for sale, there 

might be a variance for the seed treatments that would give breeders access to a much 

larger assortment of germplasm.

4. Let the marketplace guide the way

• The best way to gain more credibility in the USDA and conventional agricultural industry 

is to gain enough market share that they have to pay attention.

• Labelling of GMOs will eventually cause enough awareness in the marketplace for the 

tide to turn. Continued efforts are needed to make labelling a reality, but this is not the 

role of the NOSB.

• The marketplace is doing a lot of testing now, but are not required or inspired to share 

their results in any way to provide anonymous collective information to regulators or 

researchers. If a structure could be set up to have a central data collection system in 

which individual results could remain anonymous and no penalty assessed for 

contamination while the data was collected, the whole organic community would 

benefit.

• Whatever policy is adopted as to be workable for producers of all sizes and not solely 

favor the larger scale enterprises.

5. Thresholds and testing are a tool to be used responsibly

• The best use of testing is in specified situations, such as when negligence is suspected or 

to assess if established safeguards are sufficient.

• Many organic producers are suffering severe economic consequences already if all their 

hard work to prevent GMOs still results in contamination that lowers the value of their 

crop or is not accepted by their buyers.

• Without addressing many of the specific issues above, and also the appropriate 

repercussions when a test is failed or a threshold not met, the organic community is not 

ready for a one-size-fits-all threshold requirement.

• That being said, aiming to move towards establishing crop specific thresholds and 

standardized testing protocols is worthwhile and has a role in maintaining organic 

integrity.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 21/302
Discussion

The following are some solution-oriented suggestions that have arisen from public comment 

and from discussions within the organic community. These are broad ideas at this point and we 

have not attempted to fully flesh out the logistics of how any of these would work. They are not 

mutually exclusive for the most part. We are suggesting them as a way to get reaction from 

stakeholders on what the NOSB should work on next in this arena and what should inform that 

work. We are also open to any brand new ideas that aim to bring the organic industry towards 

consensus on improving seed purity of seed used in organic systems.

A. Enabling Data Collection

"A first step of action to protect organic seeds and crops from GMO contamination could be to 

require the evaluation of the non-GMO status of nonorganic seeds intended for use in organic 

production." This sentence is quoted from our previous work on this subject (in the Appendix). 

We could start by recommending through guidance (but not an absolute requirement subject 

to violations and penalties) for ACAs to collect a seed purity declaration from non-organic seed 

of high risk crops being planted on organic farms (preferably on the seed tag of each bag of 

seed with a lot number). If there is no seed tag, an inspector could collect a sample that could 

be sent to the ACA for an inexpensive GMO strip test. There would be no threshold, the test 

results would not be made public except as compiled anonymous data, nor would the ACA take 

any action concerning any level stated in the test. At first this program would only be for 

growers large enough to plant a whole sack or more of at-risk seed.

Waiting for the government to collect data, using non-objective data from the trade, or 

expecting the polluters to suddenly pay for this is clearly not happening soon. The tests could 

be paid for by seed companies who value organic customers, by growers themselves, by their 

contracted buyers, or by ACAs who have some funds allocated for testing. This would share 

these expenses across the supply chain without undue burden for penalties looming. Those 

who absolutely could not afford it would not be forced to do the testing in the first two years. 

This would be a big start to the data we are looking for to make future recommendations, as 

long as there was an identified home for the data to go until it is used. ACAs could turn in their 

collected data once or twice per year to a central location. The need for assembling this data is 

so great that perhaps the NOP could provide a grant to an NGO or other third party entity to 

compile the data. Possible homes might include AOSCA (American Organization of Seed Control 

Officials,) or the U.S. Testing Network, or other entities who might be willing or designated by 

the NOP. Crops grown from those reported seeds could also be tested in the marketplace and 

then matched (by ID number) in the data collection system. This would enable buyers who test 

to turn in some of their data anonymously also so that it could be correlated with seed.

If this much could be achieved for 2 to 3 years successfully then it could possibly branch into 

testing organically grown seed as well. It might also provide guidance into where contamination 

comes from, how it spreads and magnifies, and what a realistic and appropriate threshold 

might be. Other areas of expansion of these testing efforts could include buffer zones and 

various distances from a contamination source. This knowledge could lead to more fine-tuned 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 22/302
guidance on isolation distances and amount of buffers needed, and also what separation might 

be needed in timing of plantings of corn.

Only when at least several years of data were collected would there start to be policies set 

regarding protecting organic integrity from contamination coming from seeds. While there 

certainly might be flaws in this approach, it seems the most likely to enable some data to be 

collected in a way that is as timely, fair, and systematic as possible.

B. USDA Task Force

The NOSB could recommend that the USDA establish a Seed Purity Advisory Task Force. The 

task force members would be appointed by the USDA, primarily through NOP but possibly in 

conjunction with the AC21 FACA board. 

The task force would design a feasibility study based on testing that would be administered and 

carried out by USDA. The study would be crop specific and would evaluate what a rigorous yet 

realistic threshold might look like, focusing on non-organic seed. The task force would design a 

3 - 5 year action plan, after which time the testing could begin and data from it could be 

collected. 

During this time the NOSB would request the funding mechanism be established so that the 

USDA pay for all the GMO testing. The testing would not start until the funding and logistical 

details were in place.

C. Strengthening the Organic Seed requirement

Members of the Expert Panel stated that the cost of maintain each inbred line used for corn 

breeding is $8000 to $10,000 for the lab work to verify purity. This clearly is a very large 

investment for an organic breeding program or even for organic seed increase efforts. While 

the State of the Seed report will show that organic seed use is increasing, the progress has not 

been sufficient to sustain the work needed in at-risk crops. The whole viability of any efforts to 

keep GMOs out of organic are predicated on increasing the supply of organic seed with 

reasonable purity.

One of the areas that the NOSB can continue to work on is strengthening the organic seed 

provisions in the regulation through the guidance process. Many stakeholders felt that the NOP 

seed guidance issued in March 2013 did not go far enough to address the NOSB 

recommendation or the public comment in response to the draft guidance. Further suggestions 

are needed to move towards continuous improvement in this area, or what organic seed 

people are calling, "closing the loophole".

Several of the ideas for the NOSB to discuss for further recommendations include:

• How to determine continuous improvement in seed sourcing. For both ACAs and 

producers this may mean setting a percentage goal by acreage or variety, changing the 

"3 seed sources" guidance into something more specific if it is not leading to 

improvement, or asking for more measurable progress in the context of the Organic 

System Plan.

• The role of variety trials and research in compliance efforts.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 23/302
• Handlers who require certain seeds for their contracted growers should be subject to 

the organic seed requirements and procurement efforts as well as growers themselves.

There also needs to be some oversight of export traders as handlers who slip through 

the cracks of the organic seed regulations.

• NOP should provide meaningful training to ACAs annually on how to monitor progress in 

complying with the need for continuing improvement in seed sourcing. Particularly 

equal verification/enforcement for all scales of production was a frequently mentioned 

concern.

D. Start with a Soybean Testing Project

Numerous public commenters at NOSB meetings and in public gatherings have stated that 

soybean purity is relatively easily achievable compared to other at-risk crops. The NOSB could 

advance just a soybean testing mandate for both organic and non-organic seed to the proposal 

level at the next meeting. We need to determine still what the appropriate testing protocol, 

sample size, and threshold is for soybeans, as well as what happens when a test is failed. 

Starting with just one crop could provide valuable learning that would make it easier to adopt a 

more tailored proposal in the future to other crops.

E. Your ideas are welcome!

Discussion Questions 

1. Do you think that any of the suggestions above (A - D) are workable? What would you change 

to make them better?

2. Do you have a new suggestion to add under letter "E"?

3. If you think that A is workable how and where would you suggest for the testing data to be 

collected and compiled?

4. If you think that C should be taken up by the NOSB, are there other portions of the Seed 

Guidance that should be strengthened?

5. If you think that D is feasible at this time, please provide input on sample size and testing 

protocol for soybeans.

Subcommittee Vote

Motion to adopt the discussion document on Next Steps for Improving Seed Purity

Motion by: Zea Sonnabend

Second: Emily Oakley

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

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 24/302
Appendix

Discussion document on Prevention Strategies Seed Purity language, NOSB Spring 2015. 

(Withdrawn from the final Recommendation.) 

Seed Purity Requirement for Non-organic Seed

The longer we wait to set limits for controlling contamination in organic seed, feed and crops, 

the further we fall behind market demand, and the longer organic farmers are subject to the 

variability of the private market vs. the requirements of the organic regulations. A first step of 

action to protect organic seeds and crops from GMO contamination could be to require the 

evaluation of the non-GMO status of nonorganic seeds intended for use in organic production.

• The regulations require that non-organic seed be non-GMO. Organic producers must 

provide ACAs with supporting evidence that non-organic seed is non-GMO. To address 

this requirement, NOP could in guidance request that ACAs collect a seed purity 

declaration for high risk crops made (preferably on the seed tag of each bag of seed with 

a lot number) by the seed supplier or organic operation to verify the non-GMO status of 

non-organic seed. 

• Since organic seed must comply with the organic standards and is subject to residue 

sampling by ACAs, requiring seed purity declaration for organic seed could undermine 

confidence in the process-based standards. For organic seed, an organic certificate is 

adequate. However, requiring a seed purity declaration on non-organic seed would 

obligate seed suppliers or organic operations to test non-organic seed for GMOs and to 

withhold seeds that were contaminated from entering the organic supply chain. A 

suggested threshold for planting seed is 0.1%, a figure in common use.

Requiring a seed purity declaration for non-organic seed would:

• Shift the financial burden of routine GMO testing from organic seed producers to 

suppliers of non-organic seed;

• Significantly reduce the inadvertent introduction of GMOs into organic crops through 

seed; 

• Show confidence in the processed based standards that have proved successful in 

preventing pesticide contamination on organic products; and

• Incentivize the expansion of the organic seed industry

• However, such a requirement might reduce crop seed and variety options for organic 

producers if seed suppliers were unwilling to test non-organic seeds for GMOs.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 25/302
NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 26/302
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal - Hypochlorous Acid 

February 16, 2016

Summary of Proposed Action:

On May 29, 2015 the NOP received a petition to add hypochlorous acid (CAS #7790-92-3) to the National 

List of synthetic substances allowed for use in organic production and handling (7 CFR §205.600-606) at 

§205.605. This material is being petitioned for use as an antimicrobial/sanitizer for use on equipment 

and raw agricultural products.

This petition has been submitted in response to a policy memo issued by the NOP on June 9, 2014: PM 

14-3 Electrolyzed Water. That was a memo issued as a response to requests asking for the National 

Organic Program to clarify whether electrolyzed water (EW) was allowed as a sanitizer and antimicrobial 

agent for use in organic production and handling.

The NOP felt that the allowance of EW by a certifier or a material evaluation program (were based on an 

incorrect interpretation of the allowance for chlorine materials on the National List of Allowed and 

Prohibited Substances at 7 CFR 205.600-606. The NOP requested that certifiers ensure that the use of 

EW was not allowed in organic handling or production and that any party wishing for further 

consideration of EW for use in organic handling or production, should then submit a petition to get it 

added to the National List. Thus, the rationale for the petition currently before the Handling

subcommittee and the full NOSB is in response to the NOP policy memo.

Manufacture and Uses of the Substance:

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 specific ions to pass through. In the process, hypochlorous acid, hypochlorite ion, 

and hydrochloric 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)

The effectiveness of hypochlorous acid as an active sanitizing agent is determined in large part by the 

solution pH. Hypochlorous acid exists interchangeably with other chlorine species, including chlorine, 

hydrogen chloride (aqueous and gaseous) and hypochlorite. In a controlled pH environment, 

hypochlorous acid will exist as the dominant chlorine species under pH conditions ranging from 2 to 7.

(TR lines 84-89)

At a pH of 6.0-7.5 (neutral), EW contains primarily hypochlorous acid, hypochlorite ion and trace 

amounts of chlorine (TR 118-119). At pH <4.0, dissolved chlorine gas can be rapidly lost due to 

volatilization, decreasing the biocidal effectiveness of the solution over time, and also creating human 

health and safety issue (TR 150-152). Therefore it is important that neutral EW be used for sanitizing, 

not acidic EW.

EW has received recent attention as an alternative to other chlorine disinfectants and sanitizers. A 

number of studies have demonstrated the strong antibacterial activity of EW water against foodborne 

pathogens on raw agricultural products and food contact surfaces. Applications of EW as a disinfectant 

for reducing microbial contamination have been reported for fresh fruits and vegetables, poultry 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 27/302
carcasses, shell eggs, cutting boards, and food processing surfaces. Some advantages of using EW water 

are: 1) EW is as effective as any chlorine treatment, 2) it is not necessary to handle potentially 

dangerous chemicals, e.g. chlorine gas, chlorine dioxide, bleach, 3) the apparatus to produce EW is 

relative inexpensive and easy to operate, 4) because only water and sodium chloride are used EW 

production is environmentally friendly and 5) the properties of the EW can be controlled at the 

preparation site. (TR lines 99-108)

Discussion:

In general, neutral hypochlorous acid (EW) at pH 6.5-7.5 is safer to use than other chlorine-containing 

disinfectants. The concentration of chlorine present in electrolyzed water is usually over ten thousand 

times less than household bleach. There is also the advantage of its production on site, alleviating the 

need to transport dangerous material. (TR lines 616-619)

Hypochlorous acid is the same active sanitizing ingredient that is present in sodium hypochlorite and 

calcium hypochlorite. The reason hypochlorous acid can be ten thousand times less concentrated than 

sodium and calcium hypochlorite solutions and still be an effective sanitizer is that sodium and calcium 

hypochlorite solutions (bleach) have a high pH. When the pH is high, the hypochlorous acid/hypochlorite 

chemical equilibrium strongly shifts towards the presence of hypochlorite, whereas at neutral pH the 

chemical equilibrium shifts towards the presence of hypochlorous acid, the effective sanitizing 

compound. Therefore, hypochlorous acid (EW) is a safer product, for the environment and for human 

health, than chlorine sanitizer materials currently on the National List.

Evaluation Criteria 

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

Classification Motion: Move to classify hypochlorous acid as synthetic. 

Motion by: Francis Thicke 

Seconded by: Jean Richardson 

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

Listing Motion: Move to list hypochlorous acid as petitioned at §205.603 of the National List (a) As 

disinfectants, sanitizer, and medical treatments as applicable. (7) 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. (iv) hypochlorous acid.

Motion by: Francis Thicke 

Seconded by: Jesse Buie

Yes: 7 No: 0 Abstain: 1 Absent: 0 Recuse: 0

 

Approved by Ashley Swaffar, Livestock Subcommittee Chair, to transmit to NOSB February 16, 

2016

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 28/302
NOSB Evaluation Criteria for Substances Added To the National List - Livestock

Category 1. Adverse impacts on humans or the environment? Hypochlorous acid

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of 

environmental contamination 

during use or misuse? 

[§6518(m)(3)]

x According to the petition electrolyzed water 

can be made on-site. In this process there 

would not be any residual product to dispose 

of. If produced off-site and sold as a finished 

product then there could be a possibility of 

environmental contamination as the result of 

an accident or a spill. The TR does state that 

in forms of hypochlorous acid that are at a 

pH<4.0, dissolved chlorine gas can be rapidly 

lost due to volatilization, decreasing the 

biocidal effectiveness of the solution over 

time, but also creating possible human 

health and safety issues (Fisher, 2009). The 

more neutral, the pH of the material, the 

safer and more stable the substance appears 

to become.

2. Is there a probability of 

environmental contamination 

during, manufacture or disposal? 

[§6518(m)(3)]

x This substance is formed by the electrolysis 

of a sodium chloride solution. Any 

environmental concerns would be from a 

spill during manufacturing or transport of a 

formulated end product.

3. Are there any adverse impacts on 

biodiversity? (§205.200)

x The TR, (lines 596-612) does state that 

hypochlorous acid in aqueous solutions at 

pH< 7. Was of minimal toxicity to birds, but 

could be very toxic to fish and freshwater 

invertebrates. 

4. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

x Contaminants listed in the US Food and Drug 

Administration’s Guidance for Industry: 

Action Levels for Poisonous or Deleterious 

Substances in Human Food and Animal Feed, 

are unlikely to be found in hypochlorous acid 

since it is the electrolysis product of two 

generally recognized as safe materials, salt 

and water (TR lines 568-571).

5. Is there potential for detrimental 

chemical interaction with other 

materials used in organic farming 

systems? 

[§6518(m)(1)]

x The TR (lines 140-153) mentions that there 

can be a reaction with organic material 

(humic acid) which can lead to some 

potential concerns. It does go onto state 

though: It is generally accepted that 

carcinogenic and teratogenic 

trihalomethanes and haloacetic acids are not 

formed by the action of hypochlorous acid in 

neutral or near-neutral solutions (Satyawli et 

al., 2007). 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 29/302
6. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518(m)(2)]

x

7. Is there persistence or 

concentration of the material or 

breakdown products in the 

environment? [§6518(m)(2)]

x According to the TR (lines 602-612) 

hypochlorous acid solution decomposes very 

slowly in the dark but more rapidly in the 

presence of light, rapidly in full sun light by 

producing hydrogen chloride and oxygen. 

Released into the environment it is 

distributed into water and air, with an 

estimated half-life of 1-4 hours. A potential 

for bioaccumulation or bioconcentration of 

active chlorine species can be disregarded, 

because of their water solubility and their 

high reactivity.

8. Would the use of the substance 

be harmful to human health or 

the environment? [§6517 

(c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]

x Information provided in the petition states 

that compared to other types of chlorine, 

electrolyzed water is usually used at an 

active rate that is ten thousand times less 

than that of common household bleach. The 

TR (lines 624-626) mentions that the human 

innate immune system uses hypochlorous 

acid to fight infection but also directs it 

against host tissue in inflammatory diseases 

(Kettle et al.,2013). Chlorine disinfectants 

have been shown to cause occupational 

dermatitis or skin irritation (TR line 662).

9. Are there adverse biological and 

chemical interactions in the agroecosystem? [§6518(m)(5)]

x See the answer to question #5 above.

10. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518(m)(5)]

x

Category 2. Is the Substance Essential for Organic Production? Hypochlorous acid

Question Yes No N/A Comments/Documentation 

(TAP; petition; regulatory 

agency; other)

1. Is the substance agricultural? [§6502(1)] x

2. Is the substance formulated or manufactured by 

a chemical process? [§6502(21)]

x Electrolyzed water is the 

product of the electrolysis of a 

dilute sodium chloride solution 

in an electrolysis cell containing 

a semi-permeable membrane. 

This process creates 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 30/302
hypochlorous acid, hypochlorite 

ion, and hydrochlorite at the 

anode and sodium hydroxide at 

the cathode. (TR lines 48-68) 

August 13, 2015 TR.

3. Is the substance formulated or manufactured by 

a process that chemically changes a substance 

extracted from naturally occurring plant, animal, 

or mineral sources? 

[§6502(21)]

x

4. Is the substance created by naturally occurring 

biological processes? [§6502(21)]

x

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

x

6. Is there an organic substitute? 

[§205.600(b)(1)]

x Organic acids such as citric acid, 

lactic acid, malic acid, and 

vinegar are some alternative 

materials. 

7. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

x Hot water can be used in some 

instances. 

8. Are there any alternative substances? 

[§6518(m)(6)]

x Some alternative substances 

are: Sodium and/or calcium 

hypochlorite (bleach), 

isopropanol, chlorine dioxide, 

peroxyacetic acid, citric acid, 

acetic acid, ascorbic acid, and 

vinegar. Copper sulfate is 

another possible alternative 

depending on the use. 

9. Are there other practices that would make the 

substance unnecessary? [§6518(m)(6)]

x

Category 3. Is the substance compatible with organic production practices? Hypochlorous acid 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with 

organic farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

x Compared to many of the alternative 

materials currently being used electrolyzed 

water could provide a safer and effective 

alternative. (especially when produced 

using the on-site electrolysis process)

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

x See answer to question #1 of this category.

3. If used in livestock feed or pet food, is

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

x

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 31/302
4. If used in livestock feed or pet food, is

the primary use as a preservative? 

[§205.600(b)(4)]

x

5. If used in livestock feed or pet food, is

the primary use to recreate or 

improve flavors, colors, textures, or 

nutritive value lost in processing 

(except when required by law)? 

[§205.600(b)(4)]

x

6. 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

x

toxins derived from bacteria x

pheromones, soaps, horticultural 

oils, fish emulsions, treated seed, 

vitamins and minerals

x

livestock parasiticides and 

medicines

x

production aids including netting, 

tree wraps and seals, insect traps, 

sticky barriers, row covers, and 

equipment cleansers

x May be used to sanitize equipment

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 32/302
National Organic Standards Board

Livestock Subcommittee

Proposal - Annotation Change for Lidocaine and Procaine Use in Livestock Production

 January 19, 2016 

I INTRODUCTION:

Lidocaine and Procaine are local anesthetics. They are used to reduce or prevent pain during de-budding 

horns in livestock, or general minor surgery on mature livestock. They numb only the area to be worked 

on. Humane treatment of animals is critically important and the public expects high standards of animal 

welfare for organic livestock. A lengthy withholding period after treatment may result in animals not 

being treated in a timely manner, or not being treated at all. Based on new information received during 

Sunset Review in 2015 and public comment, the NOSB proposes a recommendation to reduce the 

withholding period for both lidocaine and procaine from the present 90 days to 8 days for slaughter 

stock and 6 days for milk. 

II BACKGROUND:

When added to the National List in 1995, there was no scientific rationale for the 90 day withholding, 

and the NOSB analysis in their document entitled “Local Anesthetics” provided very little information. 

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

recommendation 

In December 2007, after much public comment and consultation, the NOP agreed that the NOSB could 

require double FDA withdrawal times, or double FARAD times (when appropriate), on a number of 

livestock materials . 

“..... As a proposed compromise to satisfy the intent of the NOSB, many commenters suggested 

that USDA should consider amending the annotations of Atropine, Butorphanol, Flunixin, 

Furosemide, Tolazoline, and Xylazine by establishing extended withdrawal periods, calculated 

using withdrawal times from the Food Animal Residue Avoidance Databank(FARAD).The FARAD 

is a National Food Safety Project administered through the USDA Cooperative State Research, 

Education, and Extension Service. It is a system designed to provide livestock producers, 

extension specialists, and veterinarians with practical information on how to avoid drug, 

pesticide and environmental contaminant residue problems. FARAD is a repository of 

comprehensive residue avoidance information. It is also sanctioned to provide ‘‘withholding 

period’’ (also known as withdrawal period) estimates to the U.S. Pharmacopeia-Drug 

Information (USP–DI) Veterinary Medicine Advisory Committee. Commenters suggested that 

USDA account for an extra margin of at least double the withdrawal times of FARAD to safely 

capture the intent of the NOSB.USDA agrees with the position ..... “

“...Based on public comment, USDA consulted further with the FDA, concerning the ability to 

extend the withdrawal period on these approved drugs. Based on our consultations, USDA 

agreed to clarify the rationale for extending the FDA established withdrawal period. Secondly, 

USDA agreed to clarify the language used to authorize the use of the substances by indicating 

the extended withdrawal periods (at least two-times that required by the FDA) were only 

relevant for use of the substances under the NOP regulations. Therefore, to clarify our rationale 

for extending the withdrawal periods established by the FDA, we acknowledge that this 

determination was not based on scientific research or risk assessments. The decision to extend 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 33/302
the FDA withdrawal periods (or any other withdrawal period) for the use of Flunixin and 

Furosemide (and other substances) was based on consumer preference and the 

recommendations of the NOSB. FDA exercises full responsibility for determining and enforcing 

the withdrawal intervals for animal drugs. No food safety arguments are used or implied to 

support the use of extended withdrawal periods authorized under the NOP regulations. Rather, 

we determined that extended withdrawal periods are more compatible with consumer 

expectations of organically raised animals“ (72 FR 70479) .

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

Sunset Date: 6/27/2017 

Sunset Review took place in 2015, and lidocaine and procaine were approved for continued listing at 

the October 2015 NOSB Meeting in Stowe, Vermont. (On a motion to Remove, Vote 0:14)

III RELEVANT AREAS OF THE RULE:

Section 205.238 Livestock healthcare practice standard.

(a) The producer must establish and maintain preventive livestock healthcare practices, including ...

(5) performance of physical alterations as needed to promote the animal’s welfare and in a 

manner that minimizes pain and stress;

...

(c) The producer of an organic livestock operation must not: ...

(7) Withhold medical treatment from a sick animal in an effort to preserve its organic status. All 

appropriate medications must be used to restore an animal to health when methods acceptable 

to organic production fail. Livestock treated with a prohibited substance must be clearly 

identified and shall not be sold, labeled or represented as organically produced. 

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

(4) Lidocaine—as a local anesthetic. Use requires a withdrawal period of 90 days after 

administering to livestock intended for slaughter and 7 days after administering to dairy 

animals.

...

7) Procaine—as a local anesthetic, use requires a withdrawal period of 90 days after 

administering to livestock intended for slaughter and 7 days after administering to dairy 

animals.

IV DISCUSSION:

During the 2015 Sunset Review of Lidocaine and Procaine the Livestock subcommittee was unable to 

find any record of the rationale for the very extended withdrawal period of 90 days for these materials 

when used on slaughter stock. Historical NOSB and NOP documents from 1995 to the present were 

reviewed. The December 2007 commentary (72 FR 70479) cited above implies that perhaps the 90 days 

is a doubling of the FDA or FARAD withholding period, but no such 45 day withholding was found in FDA 

or FARAD or other sources.

In FARAD the recommended withdrawal interval for lidocaine in cattle is listed as 1 day for meat and 24 

hours for milk after epidural use of lidocaine, and 4 days for meat and 72 hours for milk after

subcutaneous use of lidocaine.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 34/302
FARAD provides information on procaine only as it relates to procaine with an antibiotic as part of 

delivery and thus it would not be used in organic production. Procaine on its own is apparently not 

readily available in the US and public comment from veterinarians only suggests a similarity with 

lidocaine. Procaine was recommended for continued listing because no public comment was provided 

to recommend its removal on any criteria. However procaine appears to be rarely used in organic 

livestock production.

During Review of these materials the NOSB in its initial request for public comment asked:

* Since this material was last reviewed have alternative materials emerged?

* What is the scientific rationale for what appears to be an excessively long withdrawal period?

* Is there research to indicate that a shorter withdrawal period would be appropriate?

Public comment did not provide any alternatives to these materials, did not provide any scientific 

rationale for the lengthy withholding period, and recommendations were received suggesting that a 

very short withholding period would be scientifically acceptable. Public comment agreed with the 

rationale of using double the FARAD time for conventional production.

In contrast to butorphanol, which is a systemic anesthetic, lidocaine and procaine numb only the area to 

be worked on. Science indicates that the half-life of lidocaine and procaine in all animals studied is very 

short, typically less than one hour. 

Based on new information and public comment during Sunset Review, the NOSB developed a Discussion 

Document to allow public comment on a possible annotation change. Public comment was received in 

Fall 2015 and discussion took place at the October 2015 NOSB meeting. 

Public comment indicates that there appears to be broad public support from farmers, dairy 

organizations, industry groups and consumer groups to reduce the withholding period in order to ensure 

humane treatment of animals. The public finds that a 90 day withholding period is far in excess of the 

withholding period used in conventional livestock production. Public comment supports a 

recommendation for slaughter stock withholding period of 8 days, which is double the FARAD 

recommendation for subcutaneous use in conventional livestock. The public supports a 

recommendation for withholding for milk of 6 days, which is double the FARAD recommendation of 72 

hours (3 days) for conventional milk production.

V RECOMENDATION: 

To amend Section 205.603(b) As topical treatment, external parasiticide or local anesthetic as 

applicable.

(4) Lidocaine—as a local anesthetic. Use requires a withdrawal period of 90 days 8 days after 

administering to livestock intended for slaughter and 7 days 6 days after administering to dairy animals 

(7) Procaine —as a local anesthetic. Use requires a withdrawal period of 90 days 8 days after 

administering to livestock intended for slaughter and 7 days 6 days after administering to dairy animals.

Sub Committee Vote : - Two Motions

1. That the deleted language be removed and underlined language added at:

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

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 35/302
(4) Lidocaine—as a local anesthetic. Use requires a withdrawal period of 90 days 8 days after 

administering to livestock intended for slaughter and 7 days 6 days after administering to dairy animals 

Motion: Jean Richardson

Second: Francis Thicke

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

2. That the deleted language be removed and underlined language added at: 

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

(7) Procaine —as a local anesthetic. Use requires a withdrawal period of 90 days 8 days after 

administering to livestock intended for slaughter and 7 days 6 days after administering to dairy animals. 

Motion: Jean Richardson

Second: Francis Thicke

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

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 36/302
National Organic Standards Board

Livestock Subcommittee

Proposal to Amend Use of Parasiticides in Organic Livestock Production

January 19, 2016

I. INTRODUCTION:

The use of parasiticides in organic production is strictly confined to emergencies. Parasiticides cannot be 

used routinely, but sick animals must be treated. Typically farmers bring clean animals into their herds 

or flocks, select breeds which have high resistance to parasites, and manage their land, especially 

pastures, in a manner which reduces the likelihood of parasite infection. If an increased parasite load is 

noted in fecal egg counts, farmers have a broad array of alternative treatments available. But when all 

else fails and animals are not doing well, the farmer, working with the veterinarian, may need to use one 

of the synthetic parasiticides on the National List.

At the present time there are three (3) substances on the National List which are approved for use as 

parasiticides for organic livestock: ivermectin, moxidectin and fenbenzadole. All three of these materials 

were reviewed in 2015 as part of the regular five-year Sunset process. At the October 2015 meeting in 

Stowe, Vermont, after considerable discussion and extensive public comment, it was recommended that 

all three parasiticides continue to be listed. Ivermectin was renewed with great reluctance owing to the 

recent research indicating serious negative impact of ivermectin on dung beetles in pastures. A 

Discussion Document was also presented at the October 2015 meeting seeking public comment on 

possible changes in use of the parasiticides. Extensive public comment indicates broad support to 

propose amendments on parasiticide use. 

All three materials have annotations and other language limiting usage. Such language was developed 

when ivermectin was first added to the National List. Recent data and information indicates that milk 

withholding and other restrictions could be modified in a manner which would be beneficial to the sick 

animal in emergency situations without jeopardizing the quality of the organic product. In conventional 

milk production, there is no withholding period for fenbenzadole or moxidectin. For organic production, 

there is a 90 day withholding period for organic milk. Synthetic parasiticides are prohibited in organic 

slaughter stock. Wool and fleece from organic fiber bearing animals, such as sheep, cannot be sold as 

organic even with a single use of a synthetic parasiticide. Organic regulations allowed moxidectin for 

internal use only. Fenbenzadole use requires a veterinarian order prior to use in organic production, but 

ivermectin and moxidectin do not have such a requirement. 

As discussed below, in 2007 it was agreed that the NOSB could use double FDA or Food Animal Residue 

Avoidance Databank (FARAD) withholding periods. 

This proposal recommends:

* That parasiticides continue to be prohibited in slaughter stock. 

* That the milk withholding period after treatment with fenbenzadole or moxidectin be changed from 

90 days to 2 days for dairy cows, and 36 days for goats and sheep. 

* That the listing for ivermectin remains as presently listed, with a 90 day withdrawal period. 

* That moxidectin be allowed for both internal and external use.

* That fleece and wool from fiber bearing animals be allowed to be certified organic even if use of 

parasiticides was necessary at some time in the animal’s life. 

* That fenbenzadole be allowed without written order of a veterinarian. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 37/302
Acronyms used herewith:

FDA – Food and Drug Administration

FARAD – Food Animal Residue Avoidance Databank

CVM – Center for Veterinary Medicine

NADA – New Animal Drugs Application – under the FDA

AMDUCA – Animal Medical Drug Use Clarification Act

NOEL – No Observable Effect Level is used by the FDA, CODEX etc. 

NRP – National Residue Program

ADI – Adult Daily Intake

MRL – Maximum Residue Limit

TR – Technical Report

Trade names—examples: 

Fenbenzadole: Panacur, Safeguard

Ivermectin: Ivomec, Primectin

Moxidectin: Cydectin

II BACKGROUND: 

In October 1999, the NOSB voted on three parasiticides for inclusion on the National List. Only 

ivermectin had sufficient votes be added to the List. The votes were: Ivermectin 8-3-0, Fenbendazole 5-

6-0, and Levamisole 0-11-0. 

In April 2004, the NOSB voted to add moxidectin to the National List by a vote of 11-1-1-1. The 

annotation, “for control of internal parasites only,” was included for moxidectin for the given reason 

that, “There is much less chance of any kind of contamination if it is used for internal parasites versus 

external“. Moxidectin was added to the National List in 2012 (77 FR 28472).

In December 2007, after much public comment and consultation, the NOP agreed that the NOSB could 

require double FDA withdrawal times, or double Food Animal Residue Avoidance Databank (FARAD) 

times (when appropriate), on a number of livestock materials: 

As a proposed compromise to satisfy the intent of the NOSB, many commenters suggested that 

USDA should consider amending the annotations of Atropine, Butorphanol, Flunixin, 

Furosemide, Tolazoline, and Xylazine by establishing extended withdrawal periods, calculated 

using withdrawal times from the Food Animal Residue Avoidance Databank (FARAD).The FARAD 

is a National Food Safety Project administered through the USDA Cooperative State Research, 

Education, and Extension Service. It is a system designed to provide livestock producers, 

extension specialists, and veterinarians with practical information on how to avoid drug, 

pesticide and environmental contaminant residue problems. FARAD is a repository of 

comprehensive residue avoidance information. It is also sanctioned to provide ‘‘withholding 

period’’ (also known as withdrawal period) estimates to the U.S. Pharmacopeia-Drug 

Information (USP–DI) Veterinary Medicine Advisory Committee. Commenters suggested that 

USDA account for an extra margin of at least double the withdrawal times of FARAD to safely 

capture the intent of the NOSB. USDA agrees with the position stated in the comments... 

Based on public comment, USDA consulted further with the FDA, concerning the ability to 

extend the withdrawal period on these approved drugs. Based on our consultations, USDA 

agreed to clarify the rationale for extending the FDA established withdrawal period. Secondly, 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 38/302
USDA agreed to clarify the language used to authorize the use of the substances by indicating 

the extended withdrawal periods (at least two-times that required by the FDA) were only 

relevant for use of the substances under the NOP regulations. Therefore, to clarify our rationale 

for extending the withdrawal periods established by the FDA, we acknowledge that this 

determination was not based on scientific research or risk assessments. The decision to extend 

the FDA withdrawal periods (or any other withdrawal period) for the use of Flunixin and 

Furosemide (and other substances) was based on consumer preference and the 

recommendations of the NOSB. FDA exercises full responsibility for determining and enforcing 

the withdrawal intervals for animal drugs. No food safety arguments are used or implied to 

support the use of extended withdrawal periods authorized under the NOP regulations. Rather, 

we determined that extended withdrawal periods are more compatible with consumer 

expectations of organically raised animals. (72 FR 70479)

In May 2008, Fenbendazole was approved by the NOSB for addition to the National List by a vote of 14-0 

and added to the National List in 2012 (77 FR 28472). The Withholding period was the same as for 

Ivermectin.

Three Technical Reports are relevant for this proposal: A 1999 TAP (fenbendazole, ivermectin); a 2003 

TAP for moxidectin; and a June 2015 Technical Report on all three parasiticides (fenbenzadole, 

ivermectin and moxidectin) requested by the Livestock subcommittee as part of its Sunset Review of 

these parasiticides. 

In 2015, all three parasiticides were reviewed as part of the regular Five Year Sunset Review. At the 

October 2015 NOSB meeting in Stowe, Vermont: 

• Moxidectin was recommended for continued listing on a Motion to Remove: 0 Yes; 12 No ; 2 

abstentions. 

• Fenbenzadole was recommended for continued listing on a Motion to Remove: 0 Yes ; 12 No ; 

2 abstentions. 

• Ivermectin was recommended for continued listing on a Motion to Remove: 6 Yes ; 4 No; 4 

abstentions. 

In addition a Discussion Document on parasiticides was presented at the October 2015 NOSB meeting. 

This is discussed below in the Discussion section.

III RELEVANT AREAS OF THE RULE: 

The USDA organic regulations at 7 CFR part 205 describe required preventive health care practices and 

regulations for the use of synthetic parasiticides in organic livestock production: 

§205.238 Livestock health care practice standard.

(a) The producer must establish and maintain preventive livestock health care practices, including: 

(1) Selection of species and types of livestock with regard to suitability for site-specific 

conditions and resistance to prevalent diseases and parasites; 

(2) Provision of a feed ration sufficient to meet nutritional requirements, including vitamins, 

minerals, protein and/or amino acids, fatty acids, energy sources, and fiber (ruminants); 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 39/302
(3) Establishment of appropriate housing, pasture conditions, and sanitation practices to 

minimize the occurrence and spread of diseases and parasites; 

(b) When preventive practices and veterinary biologics are inadequate to prevent sickness, a 

producer may administer synthetic medications: Provided, that, such medications are allowed 

under §205.603. Parasiticides allowed under §205.603 may be used on: 

(1) Breeder stock, when used prior to the last third of gestation but not during lactation for 

progeny that are to be sold, labeled, or represented as organically produced; and 

(2) Dairy stock, when used a minimum of 90 days prior to the production of milk or milk 

products that are to be sold, labeled, or represented as organic. 

§205.603 Synthetic substances allowed for use in organic livestock production. 

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

(18) Parasiticides—Prohibited in slaughter stock, allowed in emergency treatment for dairy and 

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

infestation. Milk or milk products from a treated animal cannot be labeled as provided for in 

subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur 

during the last third of gestation if the progeny will be sold as organic and must not be used 

during the lactation period for breeding stock.

(i) Fenbendazole (CAS #43210-67-9)—only for use by or on the lawful written order of a licensed 

veterinarian.

(ii) Ivermectin (CAS #70288-86-7).

(iii) Moxidectin (CAS #113507-06-5)—for control of internal parasites only. 

IV DISCUSSION:

Fenbenzadole, ivermectin and moxidectin are the only antihelmintics approved for use in organic 

livestock production. They represent two of five antihelmintic drug classes. Fenbenzadole is in the 

benzimidazole group and Ivermectin and Moxidectin are in the polyene group within the macroyclic 

lactone group. In organic livestock production they are never used on a routine basis, only in emergency 

situations. They are used in doses as indicated on the label, by body weight and species of animal, and, 

under veterinarian supervision can be used “extra label/off-label” (see detailed discussion below).

Parasiticide Uses: 

Fenbenzadole:

The US Food and Drug Administration Center for Veterinary Medicine and the US Department of 

Agriculture National Organic Program permit oral administration of fenbendazole in dairy cattle for the 

removal and control of lungworm (Dictyocaulus viviparus); brown stomach worm (Ostertagia ostertagi), 

barberpole worm (Haemonchus contortus and H. placei), small stomach worm (Trichostrongylus axei), 

hookworm (Bunostomum phlebotomum), threadnecked intestinal worm (Nematodirus helvetianus), 

small intestinal worm (Cooperia punctata and C. oncophora), bankrupt worm (Trichostrongylus 

colubriformis) and nodular worm (Oesophagostomum radiatum); in beef cattle (beef) for the removal 

and control of stomach worm (Ostertagia ostertagi ) and tapeworm (Moniezia benedeni); in goats for 

the removal and control of stomach worms (Haemonchus contortus and Teladorsagia circumcincta); in 

swine for the removal and control of lungworms (Metastrongylus apri and M. pudendotectus), 

roundworms (Ascaris suum), nodular worms (Oesophagostomum dentatum, O. quadrispinulatum), small 

stomach worms (Hyostrongylus rubidus), whipworms (Trichuris suis) and kidney worms (Stephanurus 

dentatus) and in turkeys for the removal and control of round worms (Ascaridia dissimilis) and cecal 

worms (Heterakis gallinarum). Fenbendazole is sold by Merck Animal Health as Panacur® and SafeGuard®. It is available in liquid suspension, as granules, as a paste and in blocks. Products are dispensed 

both by veterinarian’s prescription and over the counter, but must be used in organic production only 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 40/302
under veterinary supervision. For swine, turkeys, and wild sheep the NADA (141-144, 140-954, 136-116, 

131-675) for fenbendazole is for use in medicated feed only. Other uses for these animals are extralabel. 

Furthermore, the use of fenbendazole in medicated feed for domestic sheep in food production is not 

permitted by the FDA. (TR 2015, 284-302). 

Ivermectin: 

The US Food and Drug Administration Center for Veterinary Medicine and the US Department of 

Agriculture National Organic Program permit topical, subcutaneous and oral administration of 

ivermectin in cattle for the treatment and control of gastrointestinal nematodes: Haemonchus placei, 

Ostertagia ostertagi, O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, 

C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus, N. spathiger, Bunostomum 

phlebotomum, lungworms: Dictyocaulus viviparous, grubs Hypoderma bovis, H. lineatum, sucking lice: 

Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, mites: Psoroptes ovis (syn. P. 

communis var. bovis), Sarcoptes scabiei var. bovis, in reindeer for treatment and control of warbles 

(Oedemagena tarandi), in swine for treatment and control of gastrointestinal roundworms: Ascaris 

suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum species; 

threadworm, Strongyloides ransomi, somatic roundworm larvae-threadworm, Strongyloides ransomi, 

lungworms: Metastrongylus species, lice: Haematopinus suis, mites: Sarcoptes scabiei var. suis and ear 

mites: Otodectes cynotis, in american bison for the treatment and control of grubs: Hypoderma bovis 

and in sheep for treatment and control gastrointestinal roundworms: Haemonchus contortus, H. placei, 

Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. curticei, 

Oesophagostomum columbianum, O. venulosum, Nematodirus battus, N. spathiger, S. papillosus 

Chabertia, Trichuris ovis, lungworms: Dictyocaulus filaria and all larval stages of the nasal bot Oestrus 

ovis. Ivermectin is marketed by Merial, Inc. and other companies under a number of pharmaceutical 

labels. It is available as a drench, in liquid solution, for medicated feed, as a sustained release bolus and 

as a paste. Products are dispensed both by veterinarian’s prescription and over the counter. (TR 2015, 

303-321). 

Moxidectin:

The US Food and Drug Administration Center for Veterinary Medicine and the US Department of 

Agriculture National Organic Program permit topical, subcutaneous and oral administration of 

moxidectin in cattle for treatment and control of internal and external parasites, gastrointestinal 

roundworms: Ostertagia ostertagi, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia 

oncophora, C. pectinata, C. punctata, C. spatulata, C. surnabada, Bunostomum phlebotomum, 

Oesophagostomum radiatum, Nematodirus helvetianus, lungworms: Dictyocaulus viviparus, cattle 

grubs: Hypoderma bovis, H. lineatum, mites: Chorioptes bovis, Psoroptes ovis, P. communis var. bovis, 

lice: Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola(Damalinia) bovis 

and horn flies: Haematobia irritans and in sheep for the treatment and control of Haemonchus 

contortus, Teladorsagia circumcincta, T. trifurcata, Trichostrongylus axei, T. colubriformis, T. vitrinus, 

Cooperia curticei, C. oncophora, Oesophagostomum columbianum, O. venulosum, Nematodirus battus, 

N. filicollis, and N. spathiger. Moxidectin is sold by Boehringer Ingelheim Vetmedica, Inc. as Cydectin. It 

is available in liquid solution. Products are dispensed over the counter (TR 2015, 322-332).

Regulated approvals:

The use of fenbendazole for food animals is approved under six FDA New Animal Drug Applications 

(NADA) (TR 2015, Table 3). It is dispensed over the counter. The use of ivermectin for food animals is 

approved under nineteen FDA new animal drug applications. It is dispensed both by veterinary 

prescription and over the counter (Table 3). The use of moxidectin is approved under three NADAs. It is 

available over the counter. Moxidectin is in the polyene group and of macrolides and is not antibiotitic in 

its function. (TR 105-113). The approved FDA NADA numbers for the eight additional anthelmintics 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 41/302
approved by the FDA are provided in Table 3 of the TR. (TR 2015, 243-248).

“Off label/ Extra label use”. Once a NADA is approved, the FDA, under the Animal Medicinal Drug Use 

Clarification Act of 1994 (AMDUCA), can permit the use of the approved drug under specific conditions 

outside the designated or intended label use, e.g. use in species not listed in the labeling, use for 

indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or 

routes of administration other than those stated in the labeling, and deviation from the labeled 

withdrawal time based on these different uses (FDA, 1994). 

This “off-label use” is only permitted in the context of a valid veterinarian-client-patient relationship 

and is limited to treatments when the health of an animal is threatened or suffering or death may 

result from failure to treat. 

A valid veterinarian-client-patient relationship is one in which: (1) A veterinarian has assumed the 

responsibility for making medical judgments regarding the health of (an) animal(s) and the need for 

medical treatment, and the client (the owner of the animal or animals or other caretaker) has agreed to 

follow the instructions of the veterinarian; (2) There is sufficient knowledge of the animal(s) by the 

veterinarian to initiate at least a general or preliminary diagnosis of the medical condition of the 

animal(s); and (3) The practicing veterinarian is readily available for follow up in case of adverse

reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian 

has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of 

examination of the animal(s), and/or by medically appropriate and timely visits to the premises where 

the animal(s) are kept (FDA, 2015b). (TR 2015, 249-266)

For example, there is not an FDA approved use for fenbendazole in domestic sheep; however, it is used 

under veterinary supervision for this purpose. (TR 2015, 266-267)

There are some limitations for the AMDUCA including extra label use of an approved new animal or 

human drug by a lay person (except when supervised by a veterinarian). (TR 2015, 269-270).

The no observable effect level (NOEL) for parasiticides is determined by drug manufacturer and 

approved by the US Food and Drug Administration, Codex Alimentarius or other national or 

international standard setting organization. Protocols are provided by these federal agencies that detail 

testing and evaluation of the drugs. The NOEL is usually determined in an animal model. The NOEL 

values for fenbendazole, ivermectin and moxidectin are respectively, 0.7 milligram/kilogram body 

weight per day (mg/kg bd/day), 1.5 mg/kg bd/day and 10 mg/kg bd/day. The NOEL is used to determine 

the Adult Daily Intake (ADI) or the maximum residue limit (MRL). Withdrawal time is the time that it 

takes for the concentration in milk, eggs and meat that will be consumed by people to drop from the 

residue level at administration to the ADI, MRL, or safe level. (TR 2015 807-814)

Withdrawal periods for Milk: 

Fenbenzadole: FDA—zero withdrawal; FARAD does not include recommendations.

Moxidectin: FDA—zero withdrawal, although some products state not established; FARAD—Cows: zero 

withdrawal when administered topically, and not established when administered subcutaneously; 

FARAD—Goats one day for topical administration and up to 18 days if administered orally (drench) 

(based on weight of animal and dosage)

International Use and Restrictions (TR 2015, 432-507): 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 42/302
CANADA:

The organic standards of Canada prohibit the use of parasiticides with exceptions: If no alternative 

treatment exists a parasiticide may be administered under veterinary supervision as directed by the 

standard and mandated by law. Treated livestock with a withdrawal period equivalent to double the 

label requirement or 14 days, whichever is longer is still considered organic. Organic status for 

chronically infected animals is discontinued, but use in slaughter stock is allowed within limitations. 

The Canadian Organic Standard requires organic livestock operations to have a comprehensive plan to 

minimize parasite problems in livestock, including monitoring and emergency measures. Normally, 

parasiticides cannot be administered to meat, dairy or laying animals, but in emergencies, production 

operations can use them: (1) if parasites are detected, (2) under veterinary instructions, (3) with double 

the label withdrawal time or 14 days whichever is longer, (4) with one treatment for slaughter animals 

under one year and two treatments for older animals (requiring more treatments will lose organic 

status), (5) but dairy animals requiring more than two treatments lose organic status and require a 12 

month transition, (6) but dairy animals cannot be organic for slaughter, (7) and a dam may be treated 

during gestation, (8) and poultry flocks can be treated, but laying hens with more than one treatment 

per 12 months lose organic status and (9) the operator must provide a written action plan with 

amendments to the parasite control plan. 

CODEX:

The organic standards of CODEX Alimentarius, do not allow routine use of parasiticides, but they allow 

some provisions for emergency uses of parasiticides if preventive animal husbandry practices and 

natural remedies have been used and not found to be effective. Withdrawal periods should be double 

that required by legislation, with a minimum of 2 days.

IFOAM:

Like the Canadian standards, IFOAM organic standards require that use of antihelmintics will cause 

animal to lose its organic status – But an exception is allowed when livestock are treated with synthetic 

parasiticides the required withdrawal time is not less than double the withdrawal period required by 

legislation, or a minimum of 14 days, whichever is longer. And use in slaughter stock is allowed within 

limitations. 

The International Federation of Organic Agricultural Movements (IFOAM) Exception states that an 

animal can retain its organic status if the operator can demonstrate treatment is in compliance with 

IFOAM preventive animal husbandry practices, and natural and alternative medicines and treatments 

are unlikely to be effective to cure sickness or are not available to the operator, and the chemically 

synthesized allopathic veterinary medical products or antimicrobials are used under the supervision of a 

veterinarian, withdrawal periods are not less than double the withdrawal period required by legislation, 

or a minimum of 14 days, whichever is longer. The exception is granted for a maximum of three courses 

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

animal is less than one year. (TR 2015 486-494)

EEC: 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 43/302
The European Economic Community states that preventive, routine use of parasiticides is not allowed 

but in the case of a sick animal needing immediate treatment the withholding period is double the 

withdrawal. And use is allowed in slaughter stock.

JAS:

The organic standards of Japan do not specify which parasiticides may be used. The withdrawal period is 

2 days prior to slaughter for foods, milk or egg collection or twice the period of drug withdrawal. Use in 

slaughter stock is allowed.

NOP: Does not allow for use in slaughter stock, and this proposal does not recommend any changes 

to this prohibition.

Alternatives:

There are many natural alternative parasiticides being used in organic livestock production today. 

Natural parasiticides include homeopathic remedies, diatomaceous earth and many herbs with 

antihelminthic properties. Table 10 of the 2015 TR lists over 50 botanical and alternative de-wormers. 

The efficacy of most of these natural alternatives is not well documented, and more research is needed. 

However, there does seem to be a lot of potential for the development of effective natural parasite 

control systems in the future.

Livestock develop an immune response to nematodes and becomes resistant or tolerates them without 

signs of disease. Because young livestock do not have a mature immune system, they may not be able to 

mount an immune response upon infection. The same is also true for older and immuno-compromised 

animals. Worming with homeopathic and botanical remedies should begin strategically during the first 

autumn of life to accommodate the low body reserves expected with calves (Karreman, 2004). 

Homeopathic wormers are available commercially that satisfy the organic rule. These are available as 

veterinary preparations with valid labeling systems so that their use may easily be audited (Brunetti and

Karreman, 2006). Users of these remedies should be sure that the material has an appropriate potency 

and the source from which it was extracted is verified and correct. A list of natural wormers is provided 

in Table 11 of the TR. Herbal remedies with anthelminthic properties were commonly adopted and used 

as a part of traditional animal husbandry. Some have not been evaluated with modern techniques, but 

may cause toxic side effects, however in most cases they represent a good alternative to the use of 

synthetic drugs (Duval, 1997) (TR 2015, 828-840).

Brunetti and Karreman found that with proper pasture management, a good diet with plenty of forage 

for livestock and knowledgeable coaches to provide appropriate strategies for husbandry and treatment 

healthy animals can be sustainably raised without synthetic parasiticides (TR 2015 943-946). 

Public comment included many producers, all species of livestock, who consistently use alternative 

natural materials and plants, pasture and browse, who never use any synthetic parasiticides. 

Emergency use of synthetic antihelmintics is not common in organic livestock production. This proposal 

only relates to milk production, not to slaughter stock, and only in emergency situations.

Confusion in present annotation language: 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 44/302
There are some inherent contradictions and problems in the way the three parasiticides are listed and 

annotated on the National List:

1. Fenbendazole, which is considered the most environmentally benign, is annotated to require 

the “written order of a licensed veterinarian”. Ivermectin and moxidectin have no such 

requirement. That may lead producers to choose a potentially more environmentally 

detrimental parasiticide for convenience.

2. Moxidectin is annotated “for control of internal parasites only.” However, moxidectin is widely 

used as a pour-on in conventional livestock production, and when used in that form for control 

of external parasites it is also a de facto control for internal parasites. Moreover, as mentioned 

above, the annotation “for control of internal parasites only”: was apparently written based on 

incorrect information on the half-life of moxidectin in the soil.

3. §205.603(a)(18) requires a 90-day withholding period for organic milk or milk products from a 

treated animal. There seems to be wide consensus that 90 days is much too long of a

withholding period, because 1) it may motivate a producer to withhold needed treatment of an 

animal because of the severe consequences of a 90-day withdrawal, and 2) fenbendazole and 

moxidectin have no milk withdrawal time for use in conventional production. There is no 

scientific rationale for the 90 day withholding for milk. The 90 days reflects a desire to assure 

consumers that organic standards exceed conventional use of restricted materials.

Based on public comment during the first posting of these materials, in fall 2015 the NOSB posted a 

Discussion Document for public comment. The Discussion Document included the following questions:

1. Should the milk withholding period be modified for any or all of the parasiticides? If so, how 

many days for moxidectin, fenbenzadole and ivermectin? 

2. Should minimal use of parasiticides be allowed in organic slaughter stock such as is permitted 

under Canadian Organic standards with one treatment for slaughter animals under one year and 

two treatments for older animals (requiring more treatments will lose organic status)?

3. Should Sheep fleece and wool be allowed to be certified organic even if use of parasiticides was 

necessary at some time in the animal’s life?

4. Should use of Moxidectin be changed to allow both internal and external use?

5. Should use of parasiticides be allowed only under Veterinarian advice?

Public Comment:

Considerable public comment was received from a broad range of stakeholder groups and producers. 

To summarize public comment: 

* There was strong support to reduce the withholding period for milk following use of either 

fenbenzadole or moxidectin. Recommendations, based on science and research, suggested adoption of 

a withdrawal period of between zero days and 14 days as opposed to the present 90 days.

One large dairy stated the following: “We support the NOP’s consistent position of an organic milk 

withdrawal period of twice what is required by the...FDA and/or...FARAD for substances on the National 

List. However... Fenbenzadole and Moxidectin have no FDA required milk withdrawal interval and 

therefore organic dairy livestock treated with either of these substances should have milk requirement 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 45/302
withdrawal of zero days. Three other commenters also suggested zero withholding and one researcher 

commented that science indicates that small ruminants metabolize fenbenzadole even more rapidly 

than large ruminants. Research presented as part of public comment indicates Fenbenzadole in blood 

samples peaks at 7 hours and is gone from the blood in 72 hours. 

Veterinarians, consumer organizations, a trade organization, individual producers , certifiers, an 

inspector association, and dairy groups all supported reduction of the withholding period based on 

science and the FDA and FARAD.

* There was no support for reducing withholding from 90 days after treatment with ivermectin based on 

science and FARAD. Some commenters suggested the need to prohibit ivermectin treatment for 

lactating cows. 

* One certifier (Western US) noted that synthetic parasiticides are rarely used in dairy production. 

Several producers stated that they never use parasiticides.

* There was widespread public comment to remove ivermectin completely from the National list 

especially in light of recent science indicating the negative impact of ivermectin on dung beetles in 

pastures. However, some producers, notably small ruminant producers, urged that ivermectin be kept 

on the list at present for the following reasons: the fact that ivermectin is well known; has been allowed 

for the longest time; is commonly available without prior veterinarian advice or prescription; lack of 

experience of use of fenbenzadole. Veterinarians and a large dairy producer group recommended that 

ivermectin be prohibited for use on lactating cows. Since parasiticides, if used, are typically given to 

young stock, several public commenters requested that NOSB consider an annotation to state – 

Ivermectin- not for use in dairy animals of breeding age or older. Other commenters noted that because 

ivermectin is ONLY used in an emergency and not on a regular basis, dung beetle impact on organic 

pastures will be minimal.

* There was strong support to allow both external and internal use of moxidectin from individual dairy 

producers, larger dairy organizations, certifiers, an inspector organization, a trade group, and 

veterinarians. One certifier commented that the present annotation for internal and not external use 

makes verification difficult. A large dairy commented that moxidectin for both internal and external use 

is particularly critical in the Southern US states.

* There was little support for possible adoption of allowing parasiticide use in slaughter stock as per the 

Canadian Organic Standards. Consumer groups and dairy producer organizations expressed concern that 

this would reduce consumer confidence in organic food. Certifiers and veterinarians also did not support 

this suggestion. There were two individuals who felt that use of limited parasiticides could be allowed 

for slaughter stock.

* There was strong support for certification of sheep fleece and wool even after use of parasiticides. This 

support came from farmer producers, certifiers, veterinarians, farm producers in the West, consumer 

groups, an inspector organization, and trade groups. We were reminded that this is not a new idea, but 

one that was proposed to the NOSB in 1990 and never taken up by the NOSB.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 46/302
* There was mixed response to requiring veterinarian advice before use of parasiticides. Certifiers like 

the idea that veterinarians would be involved as this would make the audit trail far easier to verify. One 

certifier stated: 

Overall we support an annotation update that requires veterinarian advice because it would 

clarify how producers should document the emergency necessity for treatment and provide for 

a clear audit. Currently parasiticides are “allowed for emergency treatment,” which requires 

that organic producers describe and provide documentation about how they determined that it 

was an emergency (fecal tests, animal condition, etc.)...A vet recommendation requirement 

would be more straightforward to document and audit than the existing 

annotation...but...situations also exist when a veterinarian may not be available to assess the 

situation quickly, such as when animals are in a remote location.

Most, but not all, veterinarians support requiring veterinarian advice prior to use of parasiticides. This 

would ensure that the right dosage of the most effective parasiticide is given to the various animal 

species. One large cow dairy organization stated that there was plenty of most of the parasiticides 

available without veterinarian advice. 

To quote one of the public comments: 

In preparing this proposal to recommend amendments to use of parasiticides, the NOSB must 

be very mindful that we need to remember that livestock producers are raising multiple species 

in diverse geographic regions facing diverse climatic conditions. 

V RECOMMENDATION: 

§205.238 Livestock health care practice standard.

(a) The producer must establish and maintain preventive livestock health care practices, including: 

(1) Selection of species and types of livestock with regard to suitability for site-specific conditions 

and resistance to prevalent diseases and parasites; 

(2) Provision of a feed ration sufficient to meet nutritional requirements, including vitamins, 

minerals, protein and/or amino acids, fatty acids, energy sources, and fiber (ruminants); 

(3) Establishment of appropriate housing, pasture conditions, and sanitation practices to minimize 

the occurrence and spread of diseases and parasites; 

(b) When preventive practices and veterinary biologics are inadequate to prevent sickness, a 

producer may administer synthetic medications: Provided, that, such medications are allowed under 

§205.603. Parasiticides allowed under §205.603 may be used on: 

(1) Breeder stock, when used prior to the last third of gestation but not during lactation for progeny 

that are to be sold, labeled, or represented as organically produced; and 

(2) Dairy animals stock, when used a minimum of 90 days prior to the production of milk or milk 

products that are to be sold, labeled, or represented as organic, as allowed under §205.603. 

(3) Fiber bearing animals, as allowed under §205.603.

§205.603 Synthetic substances allowed for use in organic livestock production. 

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

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 47/302
(18) Parasiticides—prohibited in slaughter stock. Allowed in emergency treatment for dairy and 

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

infestation. Allowed in fiber bearing animals, when used a minimum of 90 days prior to production 

of fleece or wool that is to be sold, labeled, or represented as organic. Milk or milk products from a 

treated animal cannot be labeled as provided for in subpart D of this part for 90 days following 

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

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

(i) Fenbendazole (CAS #43210-67-9)—only for use by or on the lawful written order of a licensed 

veterinarian. Milk or milk products from a treated animal cannot be labeled as provided for in 

subpart D of this part for: 2 days following treatment of cattle; 36 days following treatment of goats, 

sheep, and other dairy species. 

(ii) Ivermectin (CAS #70288-86-7)—Milk or milk products from a treated animal cannot be labeled as 

provided for in subpart D of this part for 90 days following treatment. 

(iii) Moxidectin (CAS #113507-06-5)—for control of internal parasites only Milk or milk products 

from a treated animal cannot be labeled as provided for in subpart D of this part for: 2 days 

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

Sub Committee Vote:

1. That the strikethrough language be removed, and the underlined language be added at:

Section 205.238(b)(2) Dairy animals, stock when used a minimum of 90 days prior to the production of 

milk or milk products that are to be sold, labeled, or represented as organic. as allowed under 205.603. 

AND

205.603(a)(18) ....Milk or milk products from a treated animal cannot be labeled as provided for in 

subpart D of this part for 90 days following treatment . 

Motion by: Jean Richardson

Seconded by: Francis Thicke

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

2. That the underlined language be added at:

 §205.238(b)(3) Fiber bearing animals, as allowed under §205.603. 

AND

§205.603(a)(18) ... Allowed for fiber bearing animals when used a minimum of 90 days prior to 

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

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 48/302
Motion by: Jean Richardson

Seconded by: Francis Thicke

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

3. That the strike through language be removed and the underlined language added at:

205.603(a)(18)(i) Fenbendazole (CAS #43210-67-9)—only for use by or on the lawful written order of a 

licensed veterinarian. Milk or milk products from a treated animal cannot be labeled as provided for in 

subpart D of this part for: 2 days following treatment of cattle; 36 days following treatment of goats, 

sheep and other dairy species. 

Motion by: Jean Richardson

Seconded by: Francis Thicke

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

4. That the underlined language added at:

205.603(a)(18) (ii) Ivermectin (CAS #70288-86-7)—Milk or milk products from a treated animal cannot 

be labeled as provided for in subpart D of this part for 90 days following treatment. 

Motion by: Jean Richardson

Seconded by: Francis Thicke

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

5. That the strike through language be removed and the underlined language added at:

205.603(a)(18) (iii) Moxidectin (CAS #113507-06-5)—for control of internal parasites only Milk or milk 

products from a treated animal cannot be labeled as provided for in subpart D of this part for: 2 days 

following treatment of cattle; 36 days following treatment of goats, sheep and other animals. 

Motion by: Jean Richardson

Seconded by: Francis Thicke

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

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 50/302
National Organic Standards Board 

Policy Development Subcommittee 

Policy and Procedures Manual Revision – Proposal 

February 23, 2016

Introduction and Background 

The Policy and Procedures Manual (PPM) of the National Organic Standards Board (NOSB) was first adopted 

on October 19, 2002. Since its adoption the PPM has been revised 12 times with 11 revisions occurring from 

2007-2011. Since April 11, 2012 this document has not been revised. The PPM was establish to assist the 

board in the implementation of its duties under OFPA and to establish operating procedures and policies for 

the board. In order to bring the PPM in line with the current operations of the board the PDS has been 

undertaking revisions to the PPM and presented a draft version at the October 2015 NOSB meeting for 

discussion. Public comments were received and full board discussion occurred on the proposed revised 

PPM. The PDS has revised these comments, made revisions where necessary and is presenting this revised 

PPM for Board approval. 

Objective 

The objective of this proposal to revise the April 11, 2012 version of the PPM to reflect the current 

procedures for the collaborative and productive functioning of the NOSB. It is designed to assist the NOSB in 

its responsibilities to serve as a link to the organic community, advise USDA on the implementation of OFPA, 

propose amendments to the National List of Allowed and Prohibited Substances and protect/defend the 

integrity of organic standards. It compliments and aligns with other governing documents including the 

Organic Foods Production Act (OFPA), the USDA organic regulations at 7 CFR Part 205, the NOSB Charter, 

FACA procedures and other government laws and regulations (ie FOIA) as applicable. 

Public Comment Discussion 

Brief summary of comments PDS Response

Proposed changes to the PPM 

need to be more transparent. (6 

comments)

The PDS acknowledges there were a number of formatting, 

ordering, grammatical as well as content changes that make 

comparing the April 2011 version to the proposed version difficult. 

The PPM was revised 11 times in a 5 year period and then not 

touched for 4 years - clearly a number of edits are needed bring 

this document up to date. To make the changes to the PPM more 

transparent a redline version of the document as well as a table of 

contents comparison are provided. Due to the global nature of the 

changes, the redline version provides limited value in comparing 

the two documents.

The PPM should reflect the public 

information disclosure 

requirements of FACA in addition 

to FOIA. (4 comments)

The PDS agrees that the PPM should align and comply with other 

governing documents the PDS has revised Section III I Additional

Administrative Items bullet fourth and fifth bullet points to include 

FACA disclosure requirements along with FOIA.

Conflict of Interest policy of 

Technical Reviews (TR) and 

Technical Advisory Panels (TAP) 

need to be transparent and the 

authoring party needs to be listed 

on the TR/TAP. (4 comments)

The PDS agrees that the procedures for disclosing conflicts of 

interest are important and need to be transparent as well as 

aligned with the contracting procedures of the federal 

government. It is clarified in section VI H 3 in the sixth bullet point 

that the contracting party will be named on the TR/TAPs and the 

conflict of interest protocols to be followed for the contracting of 

TR/TAPs. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 51/302
FACA definition of non-public 

information should be used in 

place of the FOIA definition. (3 

comments)

The PDS agrees that the PPM should align and comply with other 

governing documents the PDS has revised Section III I Additional 

Administrative Items bullet fourth and fifth bullet points to include 

FACA disclosure requirements along with FOIA.

Changes to the PPM need to be 

approved by the full board. (1 

comment)

The PDS agrees and added section IX to reflect this clarification.

NOSB and NOP collaboration 

section less collaborative than 

older version. (1 comment)

The PDS revised Section III E to reflect the importance of both 

NOP-NOSB collaboration as well as NOP-NOSB mutuality in their 

respective roles in the organic community.

The PDS's responsibilities do not 

reflect its role in reviewing and 

proposing changes to the PPM. (1 

comment)

The PDS has revised Section IV A to reflect the PDS's role in revising 

the PPM and other internal policy documents. 

Does not address section §6518(j) 

of OFPA, “The Secretary shall 

authorize the Board to hire a staff 

director.” (1 comment)

The PPM should reflect the current operating procedures of the 

NOSB. Since the NOSB has never had the budget or the recognized 

authority to hire a staff director due to conflicting government 

regulations and laws - this is not included in this revision.

Removes NOSB authority to 

initiate agenda items. (1 comment)

The PDS revised Section III F to reflect the collaborative nature 

under which work plans are set with the program. The NOSB has 

the authority to initiate work agenda items and bring them to the 

Executive Committee and the NOP for confirmation. The proposed 

revisions bring the PPM into alignment with the NOSB Charter.

The section on the Advisory 

Committee Specialist (ACS) deletes 

this

sentence: “The most important 

function of the ED is to facilitate 

the operation of the Board, while 

helping to maintain and 

strengthen its independence.” (1 

comment)

The PDS agrees that the most important function of the ACS is to 

facilitate the operations of the board along with facilitating 

communication and collaboration with the program. These section 

have remained. It is unfair and a conflict of interest to have this 

position take on the role of maintaining the board's independence.

Changes to the requirements for 

minority reports decrease the full

understanding of the

NOSB and the public. (1 comment)

The PDS disagrees with this comment. The minority view section 

was revised to better integrate the minority view into the final 

NOSB proposal and discussion as well as to facilitate a collaborative 

NOSB process. Objections raised by this commenter advocate for 

the NOSB to maintain an uncollaborative and potentially 

unproductive process with its own members - this is opposite to 

the objective of the PPM.

NOSB and NOP Conflict of Interest 

(COI) policies for NOSB members. 

(1 comment)

The PDS believe the COI procedures for NOSB members is clear and 

aligned with other governing documents. 

NOSB policy for forced 

resignations needs to be better 

defined. (1 comment)

The NOSB has no authority to force the resignation of any of its 

members, this authority lies with the Secretary. This section only 

details circumstance where members should be encouraged to 

resign if they are not participating in the work of the NOSB.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 52/302
Objections to greater meeting 

accessibility. (1 comment)

The NOSB strives to increase access to its meetings to members of 

the public and to its own members, regardless of their abilities to 

travel to the NOSB meeting. It would not be in the interest of the 

public, the NOSB and people of all abilities to limit access and 

refuse to use current common communication technology where 

the medical need is present. 

The PPM should not adopt current 

Sunset procedures used by the 

Board.

The PPM should reflect the current operating procedures of the 

NOSB. 

Attachments 

Proposed Policy and Procedures Manual Draft February 23, 2016 (Clean) 

Redline Policy and Procedure Manual comparing Draft February 23, 2016 to April 11, 2012 version 

Table of Contents Comparison February 23, 2016 to April 11, 2012 version 

Proposal 

The NOSB moves to adopt the February 23, 2016 drafted version of the Policy and Procedures Manual. 

Subcommittee Vote 

The NOSB PDS subcommittee approves the three sections of this proposal as stated above. 

Motion by: Tom Chapman 

Second: Lisa de Lima 

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

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 53/302
PPM Change Table

Last revised PPM (April 11, 2012) Proposed PPM (Mar 1 2016 Change

I Introduction I. Introduction Updated

I NOSB Vision Statement I.A NOSB Vision Statement No material change

I NOSB Statutory Mission I.B NOSB Statutory Mission No material change

I NOSB Mission Statement I.C NOSB Mission Statement No material change

I Duties of Board and Officers

III.C Responsibilities of the Board

Appendix I: Foundations Updated

I Maintaining Professional and Ethical 

Standards

III.J Professional and Ethical Standards

III.K Conflict of Interest Updated

II Board Member Job Descriptions

I. Introduction

III.A NOSB Membership Updated

II Board Member Standards III.J Professional and Ethical Standards Updated

II Conducting Business VIII.B Conducting Business Updated

III Role of Executive Director III.H Advisory Committee Specialist Updated

III Officer Responsibilities III.D NOSB Officers Updated

III Election of Officers VIII.F Election of Officers Updated

III Executive Committee IV.A Standing Subcommittees Updated

III Meetings VIII.A Board Meetings Updated

IV Board Committees IV.A Standing Subcommittees Updated

IV Committee Meetings IV.C Subcommittee Meetings Updated

IV Standing Committees IV.A Standing Subcommittees Updated

IV Task Forces IV.D Task Forces Updated

IV Ad Hoc Committees IV.B Ad Hoc Subcommittees Updated

V Duties of Committee Chairs

IV.E Duties of Subcommittee Chairs and 

Vice Chairs Updated

V Duties of Committee Vice Chairs

IV.E Duties of Subcommittee Chairs and 

Vice Chairs Updated

V Procedures for transitioning of 

Committee Chairs

IV.F Transition of Subcommittee Chairs, 

Vice Chairs and Members (New and 

Continuing) Updated

V Procedures for completing 

Committee Recommendations

IV.G Procedures for completing 

Subcommittee Proposals and Discussion 

Documents Updated

V NOSB-NOP Collaboration III.E NOSB-NOP Collaboration Updated

VI Miscellaneous Policies

VIII.G Miscellaneous Procedures

VIII.E Public Comment Updated

VII NOSB Principles of Organic 

Production and Handling Appendix I: Foundations Moved

VII NOSB Guidance of Compatibility 

with a System of Sustainable 

Agriculture and Consistency with 

organic Farming and Handling Appendix I: Foundations Moved

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 54/302
VIII Committee Work Plans III.F NOSB Work Agendas Updated

VIII Materials Review Process IV.H Substance/Materials Review Process Updated

VIII Procedures for Handling Technical 

Reviews IV.H Substance/Materials Review Process Updated

VIII Handling Withdrawals of Petitions 

by the Petitioner

VI. Withdrawal of a Petition by a 

Petitioner Updated

VIII Technical Advisory Panel Contract 

Procedures IV.H Substance/Materials Review Process Updated

VIII Information to be Included in a 

Petition IV.H Substance/Materials Review Process Updated

VIII Priority of Petitions Guideline V. Prioritization of Petitions Updated

VIII NOSB Committee 

Recommendation -removedMoved to Member Guide

VIII Evaluation Criteria for Substance 

added to the National List -removedMoved to Member Guide

VIII NOSB Recommended Decision 

Form

VIII.D NOSB Deliberations and 

Recommendations

Updated/Moved to 

Member Guide

VIII Procedures for the Materials 

Review Process for NOSB Members IV.H Substance/Materials Review Process Updated

VIII Sunset Review Process VII Sunset Review Process Updated

VIII Handling Technical Errors After an 

Item has been Placed in the Federal 

Register -removed- Removed

Appendix A Decision Making 

Procedures for the NOP -removed- Removed

Appendix B FACA Facts Appendix II: Faca Facts No material change

Appendix C Duties of the Designated 

Federal Officers III.G Designated Federal Officer Updated

Appendix D Parliamentary Procedures 

at a Glance VIII.C Parliamentary Procedures Updated/Removed

Appendix E Basic Chemistry -removed- Removed

II.A OFPA Added

II.B FACA Added

II.C NOSB Charter Added

III.B Nomination and Appointment Added

III.I Additional Administrative Items Added

IX. Revisions to the Policy and Procedures 

Manual Added

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 55/302
NATIONAL ORGANIC STANDARDS BOARD 

 

POLICY AND PROCEDURES MANUAL

 

 

 

Adopted October 19, 2002 

Revised August 18, 2005

Revised March 29, 2007

Revised November 30, 2007

Revised May 22, 2008

Revised November 19, 2008

Revised May 6, 2009

Revised November 9, 2009

Revised April 29, 2010

Revised October 28, 2010

Revised April 29, 2011

Revised December 2, 2011

Revised April 11, 2012

Draft Feb. 23, 2016

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 56/302
NATIONAL ORGANIC STANDARDS BOARD (NOSB)

POLICY AND PROCEDURES MANUAL

Contents

I. INTRODUCTION/PURPOSE......................................................................................................................... 4

A. NOSB VISION STATEMENT.............................................................................................................................. 4

B. NOSB STATUTORY MISSION ........................................................................................................................... 4

C. NOSB MISSION STATEMENT ........................................................................................................................... 4

II. AUTHORIZATION........................................................................................................................................ 5

A. ORGANIC FOODS PRODUCTION ACT OF 1990................................................................................................... 5

B. FEDERAL ADVISORY COMMITTEE ACT ............................................................................................................. 5

C. NATIONAL ORGANIC STANDARDS BOARD CHARTER ........................................................................................ 5

III. NOSB ADMINISTRATION ............................................................................................................................ 5

A. NOSB MEMBERSHIP .......................................................................................................................................... 5

B. NOMINATION AND APPOINTMENT PROCESS............................................................................................................... 6

C. RESPONSIBILITIES OF THE NOSB ............................................................................................................................ 6

D. NOSB OFFICERS ............................................................................................................................................. 8

CHAIR........................................................................................................................................................... 8

VICE CHAIR................................................................................................................................................... 8

SECRETARY .................................................................................................................................................. 8

ADMINISTRATIVE TEAM ............................................................................................................................... 9

E. NOSB-NOP COLLABORATION.......................................................................................................................... 9

F. NOSB WORK AGENDAS ................................................................................................................................ 10

G. DESIGNATED FEDERAL OFFICER ............................................................................................................................ 11

H. ADVISORY COMMITTEE SPECIALIST ....................................................................................................................... 12

I. ADDITIONAL ADMINISTRATIVE ITEMS........................................................................................................... 12

J. PROFESSIONAL AND ETHICAL STANDARDS .................................................................................................... 14

1) NOSB Member Professional Conduct Standards................................................................................. 14

2) Additional Standards of Conduct ...................................................................................................... 14

3) Failure to participate ....................................................................................................................... 15

K. DECLARATION OF INTERESTS/CONFLICT OF INTEREST .......................................................................................... 15

IV. SUBCOMMITTEES ..................................................................................................................................... 18

A. STANDING SUBCOMMITTEES ....................................................................................................................... 18

B. AD HOC SUBCOMMITTEES............................................................................................................................ 19

C. SUBCOMMITTEE MEETINGS ......................................................................................................................... 19

D. TASK FORCES............................................................................................................................................... 20

E. DUTIES OF SUBCOMMITTEE CHAIRS AND VICE CHAIRS ................................................................................... 20

F. TRANSITION OF SUBCOMMITTEE CHAIRS, VICE CHAIRS, AND MEMBERS (NEW AND CONTINUING)...................20

G. PROCEDURES FOR COMPLETING SUBCOMMITTEE PROPOSALS AND DISCUSSION DOCUMENTS .......................22

1. Development of proposals..................................................................................................................... 22

2. Types of Proposals................................................................................................................................ 23

3. Presenting Subcommittee Proposals and Discussion Documents at NOSB Meetings ................................. 23

H. SUBSTANCE/MATERIALS REVIEW PROCESS ................................................................................................... 23

1. Steps in the material review process for a new petition: ......................................................................... 24

2. Changes to annotations or classification of materials............................................................................. 27

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 57/302
3. Additional considerations concerning Technical Reviews ....................................................................... 28

4. Definitions ........................................................................................................................................... 28

V. PRIORITIZATION OF PETITIONS..................................................................................................................... 28

VI. WITHDRAWAL OF A PETITION BY A PETITIONER............................................................................................ 29

VII. SUNSET REVIEW PROCESS............................................................................................................................ 30

VIII. NOSB PROCEDURES .................................................................................................................................. 31

A. BOARD MEETINGS ....................................................................................................................................... 31

B. CONDUCTING BUSINESS............................................................................................................................... 31

C. PARLIAMENTARY PROCEDURES.................................................................................................................... 32

D. NOSB DELIBERATIONS AND RECOMMENDATIONS ......................................................................................... 32

E. PUBLIC COMMENT....................................................................................................................................... 33

F. ELECTION OF OFFICERS................................................................................................................................. 34

G. MISCELLANEOUS PROCEDURES .................................................................................................................... 35

1. Invited Speakers................................................................................................................................... 35

2. Surveys Conducted on Behalf of NOSB Subcommittees............................................................................ 36

IX. REVISIONS TO THE POLICY AND PROCEDURES MANUAL ....................................................................... 36

X. APPENDICES.............................................................................................................................................. 37

A. APPENDIX 1: FOUNDATIONS ........................................................................................................................... 37

1. NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING.............................................................37

2. NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE AGRICULTURE AND 

CONSISTENCY WITH ORGANIC FARMING AND HANDLING ........................................................................... 39

3. NOSB MEMBER DUTIES........................................................................................................................ 39

B. APPENDIX 2 – FACA FACTS .............................................................................................................................. 41

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 58/302
I. INTRODUCTION/PURPOSE 

This document provides procedures for the functioning of the National Organic Standards Board

(NOSB) and is designed to assist the NOSB in its responsibilities. This policy and procedures manual 

does not supersede authority or responsibilities as specified in the Federal Advisory Committee Act

or the Organic Foods Production Act (OFPA). NOSB members are encouraged to review this manual 

in depth as well as to become familiar with the OFPA, the USDA organic regulations at 7 CFR Part 

205, and the NOSB Member Guide. Members are advised to periodically review the contents to 

refresh their understanding of the NOSB’s role and duties. NOSB members are entrusted with the 

responsibility to act in the best interests of all members of the organic community and the public at 

large. The NOSB’s success relies upon the ability to understand each other’s respective roles, and to 

develop successful working relationships. 

The primary roles and duties of the National Organic Standards Board (NOSB): 

• Serve as a link to the organic community

• Advise USDA on the implementation of OFPA 

• Propose amendments to the National List of Allowed and Prohibited Substances

• Protect and defend the integrity of organic standards

A. NOSB VISION STATEMENT 

(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007).

The NOSB’s vision is an agricultural community rooted in organic principles and values that 

instills trust among consumers, producers, processors, retailers and other stakeholders. 

Consistent and sustainable organic standards guard and advance the integrity of organic 

products and practices. 

 

B. NOSB STATUTORY MISSION 

(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007).

To assist in the development of standards for substances to be used in organic production and 

to advise the Secretary on any other aspects of the implementation of this title. (OFPA, Sec 2119 

(a))

C. NOSB MISSION STATEMENT 

(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007).

To provide effective and constructive advice, clarification and guidance to the Secretary of 

Agriculture concerning the National Organic Program (NOP), and the consensus of the organic 

community. 

Key activities of the Board include: 

• Assisting in the development and maintenance of organic standards and regulations

• Reviewing petitioned materials for inclusion on or removal from the National List of 

Approved and Prohibited Substances (National List) 

• Recommending changes to the National List 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 59/302
• Communicating with the organic community, including conducting public meetings, 

soliciting and reviewing public comments 

• Communicating, supporting and coordinating with the NOP staff 

II. AUTHORIZATION

The National Organic Standards Board (NOSB) is authorized under Section 2119 of the Organic 

Foods Production Act of 1990 (OFPA) (7 U.S.C. 6519), part of the Food, Agriculture, Conservation, 

and Trade Act of 1990 (FACT Act). The OFPA specified that the NOSB be established in accordance 

with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App. 2. 

A. ORGANIC FOODS PRODUCTION ACT OF 1990

The Organic Foods Production Act of 1990 (OFPA) authorizes the Secretary of Agriculture to 

establish a National Organic Standards Board (NOSB) in accordance with the Federal Advisory 

Committee Act to assist in the development of standards for substances to be used in organic 

production and to advise the Secretary on any other aspects of the implementation of OFPA

(OFPA, 7 U.S.C. Section 6518(a)). 

B. FEDERAL ADVISORY COMMITTEE ACT

The Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and its implementing regulations 

(41 CFR Part 101-6.10) govern the creation, operation, and termination of advisory committees 

in the Executive Branch of the Federal Government. The National Organic Standards Board 

(NOSB) is a Department of Agriculture (USDA) non-discretionary advisory committee required by 

the Organic Foods Production Act of 1990, as amended. 

C. NATIONAL ORGANIC STANDARDS BOARD CHARTER

The Federal Advisory Committee Act requires advisory committees to have an official charter 

prior to meeting or taking any action. An advisory committee charter is intended to provide a 

description of an advisory committee’s mission, goals, and objectives. The NOSB charter is 

renewed every two years as a requirement of FACA. The NOSB charter describes the purpose of 

the NOSB to “assist in the development of standards for substances to be used in organic 

production and to advise the Secretary on any other aspects of the implementation of OFPA.” 

III. NOSB ADMINISTRATION

A. NOSB Membership 

OFPA specifies the membership composition of the NOSB as follows. The NOSB shall be 

composed of 15 members, of which:

• Four shall be individuals who own or operate an organic farming operation;

• Two shall be individuals who own or operate an organic handling operation;

• One shall be an individual who owns or operates a retail establishment with significant trade 

in organic products;

• Three shall be individuals with expertise in areas of environmental protection and resource 

conservation;

• Three shall be individuals who represent public interest or consumer interest groups;

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 60/302
• One shall be an individual with expertise in the fields of toxicology, ecology, or biochemistry; 

and

• One shall be an individual who is a certifying agent as identified under OFPA, 7 U.S.C.

§ 6518(b)

B. Nomination and appointment process 

(NOSB recommendation adopted June 10, 1999)

NOSB members are appointed by the Secretary of Agriculture to a five year term. The terms are 

staggered and the USDA periodically requests nominations to fill upcoming vacancies. Selection 

criteria include the following: 

• A general understanding of organic principles, and practical experience in the organic 

community, particularly in the sector for which the person is applying

• Demonstrated experience in the development of public policy such as participation on 

public or private advisory boards, boards of directors or other comparable organizations

• Participation in standards development and/or involvement in educational outreach 

activities

• A commitment to the integrity and growth of the organic food and fiber industry

• The ability to evaluate technical information and to fully participate in Board deliberation 

and recommendations

• The willingness to commit the time and energy necessary to assume Board duties

• Not currently serving (or have been elected to serve) on another USDA advisory committee 

or research and promotions council/board during your term

• Not registered as a lobbyist with the federal or state government

NOSB members serve without compensation. NOSB members are reimbursed by the USDA for 

approved travel and associated lodging expenses as determined by official federal government 

guidelines and regulations. In accordance with USDA policies, equal opportunity practices are 

followed in all appointments to the NOSB. Membership shall include to the extent possible the 

diverse groups served by USDA, including minorities, women, and persons with disabilities. 

The USDA prohibits discrimination in all of its programs and activities on the basis of race, color, 

national origin, age, disability, and where applicable, sex, marital status, familial status, parental 

status, religion, sexual orientation, political beliefs, genetic information, reprisal, or because all 

or part of an individual's income is derived from any public assistance program.

C. Responsibilities of the NOSB

(OFPA, 7 USC 6518(k)):

(1) In General. The Board shall provide recommendations to the Secretary regarding the implementation 

of this chapter. 

(2) National List. The Board shall develop the proposed National List or proposed amendments to the 

National List for submission to the Secretary in accordance with section 6517 of this title. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 61/302
(3) Technical Advisory Panels. The Board shall convene technical advisory panels to provide scientific 

evaluation of the materials considered for inclusion in the National List. Such panels may include experts 

in agronomy, entomology, health sciences and other relevant disciplines. 

(4) Special Review of Botanical Pesticides. The Board shall, prior to the establishment of the National List, 

review all botanical pesticides used in agricultural production and consider whether any such botanical 

pesticides should be included in the list of prohibited natural substances. 

(5) Product Residue Testing. The Board shall advise the Secretary concerning the testing of organically 

produced agricultural products for residues caused by unavoidable residual environmental contamination. 

(6) Emergency Spray Programs. The Board shall advise the Secretary concerning rules for 

exemptions from specific requirements of this chapter (except the provisions of section 6511 of 

this title) with respect to agricultural products produced on certified organic farms if such farms 

are subject to a Federal or State emergency pest or disease treatment program. 

Requirements. (OFPA 6518(l)) 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, and other sources as appropriate, 

concerning the potential for adverse human and environmental effects of substances 

considered for inclusion in the proposed National List; 

(2) work with manufacturers of substances considered for inclusion in the proposed 

National List to obtain a complete list of ingredients and determine whether such 

substances contain inert materials that are synthetically produced; and 

(3) submit to the Secretary, along with the proposed National List or any proposed 

amendments to such list, the results of the Board's evaluation and the evaluation of 

the technical advisory panel of all substances considered for inclusion in the National 

List. 

Evaluation. (7 USC 6518(m)) In evaluating substances considered for inclusion on the National 

List the NOSB shall consider: 

1. the potential of such substances for detrimental chemical interactions with other 

materials used in organic farming systems; 

2. 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; 

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

disposal of such substance; 

4. the effect of the substance on human health; 

5. the effects of the substance 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; 

6. the alternatives to using the substance in terms of practices or other available 

materials; and 

7. compatibility with a system of sustainable agriculture. 

Petitions. (7 USC 6518(n)) 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 62/302
The board shall establish procedures for receiving petitions to evaluate substances for inclusion 

on the List

Sunset Provision. (7 USC 6517 (e)) No exemptions or prohibition contained in the National List 

shall be valid unless the National Organic Standards Board has reviewed such exemption or 

prohibition as provided in this section within 5 years of such exemption or prohibition being 

adopted or reviewed and the Secretary has renewed such exemption or prohibition. 

D. NOSB OFFICERS

Three principal officers, Chair, Vice Chair and Secretary, guide the NOSB. The NOSB 

members hold an election each fall at the public meeting to elect these three members.

CHAIR 

The Chair is responsible for ensuring the integrity of the NOSB process, effectiveness of 

meetings and adherence to NOSB policies and procedures. The primary duties of the 

Chair are as follows: 

• Schedules meetings of the Executive Subcommittee, in collaboration with the NOP

• Serves as a member of, convenes, and facilitates Executive Subcommittee meetings 

• Convenes and presides over NOSB meetings 

• Participates in the administrative team meetings

• Drafts NOSB meeting agendas in consultation with Subcommittee chairs and the 

NOP 

• Reviews Subcommittee work agendas 

• Reviews NOSB meeting minutes for accuracy 

• Assists with the annual election of NOSB officers and announces the new officers

VICE CHAIR 

The Vice Chair acts in the absence of the Chair. The primary duties of the Vice Chair are 

as follows: 

• Serves as a member of the Executive Subcommittee

• Participates in the administrative team meetings

• Serves as a member of the Policy Development Subcommittee

• Helps maintain the Policy and Procedures Manual and ensures its accuracy 

SECRETARY 

The primary duties of the Secretary are as follows: 

• Serves as a member of the Executive Subcommittee

• Participates in the administrative team meetings

• Records all NOSB member votes at NOSB meetings, and in collaboration with the 

Advisory Committee Specialist (ACS), circulates that record to NOSB members for 

approval 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 63/302
• Assists with the annual election of NOSB officers 

• May delegate tasks to others, but retains responsibility for the official record 

ADMINISTRATIVE TEAM 

The Administrative Team consists of the Chair, Vice Chair, Secretary, and Designated 

Federal Official/Advisory Committee Specialist. . This group is responsible for 

coordinating logistics and operations of the Board. The Administrative team meets via 

teleconference once or twice a month on an as-needed basis, to be determined by the 

Administrative Team.

E. NOSB-NOP COLLABORATION 

In 1990, the Organic Foods Production Act (OFPA: 7 U.S.C. 6518 (a)) directed the Secretary of 

Agriculture to “establish a National Organic Standards Board (in accordance with the Federal 

Advisory Committee Act (FACA)) ... to assist in the development of standards for substances to 

be used in organic production and to advise the Secretary on any other aspects of the 

implementation” of the Act. Section 6503 (a) of the OFPA requires that the Secretary “shall

establish an organic certification program ... and shall consult with the NOSB” (6503(c)). The 

National Organic Program (NOP) is the governmental institution responsible for implementing 

the OFPA and is the means through which the NOSB provides advice and assistance to the 

Secretary of Agriculture. The NOSB, as a FACA advisory committee, must conduct business in 

the open, under the requirements of P.L. 94-409, also known as “Government in the Sunshine 

Act” (5 U.S.C.552b). 

The USDA cannot delegate its authority as a regulatory body to private citizens, even when 

those private citizens are appointed by the Secretary to provide advice. Therefore, the NOSB 

cannot direct USDA or bind the Secretary through its actions; for example, it cannot obligate 

funds, contract, make NOP staffing decisions, or initiate policies of its own accord 

However, the NOSB has unique statutory authority related to the recommendation of materials 

as approved or prohibited substances for inclusion on the National List. 

The unique nature of the NOSB and its relationship with the NOP, as established through OFPA, 

requires that the volunteer Board, which regularly receives stakeholder input through public 

comment, must work collaboratively with the NOP.

Similarly the NOP, as required through OFPA, must consult and collaborate with the NOSB

Team work and collaboration between the NOSB and the NOP, as well as others in the organic 

community, is needed to maintain, enhance and promote the integrity of organic principles and 

products. Successful collaboration is dependent on effective communication and constructive 

feedback. Communication is facilitated by the Advisory Committee Specialist, who participates 

in all NOSB calls. Additionally, the NOP Deputy Administrator or designee will participate in all 

ES calls, and in other standing Subcommittee calls upon request and mutual agreement. In 

addition, each standing Subcommittee will be assigned an NOP staff person to provide 

technical, legal, and logistical support.

The work of the NOP and NOSB since the 1990 passage of the OFPA clearly demonstrates the 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 64/302
need for the high level of collaboration and consultation described above. NOP, NOSB and its 

associated stakeholders must continuously work to seek common ground, collaborate and 

consult in order to build organics and maintain organic integrity. Every aspect of this work 

must take place in a manner which clearly demonstrates mutual respect and positive intent. 

F. NOSB WORK AGENDAS

The NOSB Work agenda is a list of projects for the upcoming semester or year for each of the 

Subcommittees. Agendas are developed via collaboration between the NOSB and the NOP and 

are revised based on AMS-NOP requests, NOSB priorities, and public comment. 

Work agendas are developed based on the following criteria: 

• Within Scope: Item must be within the scope of OFPA. NOP must have a clear sense of the 

intent and scope of the work agenda item. The public may petition additions or deletions 

from the National List that will be added to the work agenda. In addition, the public may 

submit comments to the NOSB or write to the NOP for potential additions to the work 

agenda. For the NOSB, work agenda items may emerge from discussions on current issues.

• USDA and NOP Priority: Item must be a priority for the USDA/NOP; something that the NOP 

is able to implement in a reasonable timeframe. 

• Clear Need: Item must reflect a clear need for the NOP and/or organic community, for 

which new or additional information or advice is needed. 

The NOSB work agenda establishes Subcommittee work for the upcoming semester or year, and 

is developed through the following process: 

1. NOSB Subcommittees submit to the Executive Subcommittee draft work agenda items 

based on AMS-NOP requests, NOSB priorities, and requests from public comment. 

2. The NOP and Executive Subcommittee review the draft NOSB work agenda. The content and 

schedule will be reviewed on an ongoing, as needed basis. 

3. NOP confirms the final NOSB work agenda, and provides written confirmation. . 

Work agenda items should be prioritized accordingly:

1. Substance evaluations (e.g., 5-year sunset review, petitions) 

2. NOP requests to the NOSB 

3. NOSB requests to NOP

4. Other projects

Below are descriptions of common NOSB work agenda items and the corresponding NOP and NOSB 

responsibilities. 

• Review of materials proposed to be added to or removed from the National List

The NOSB has the statutory authority to consider and recommend materials for addition to, 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 65/302
or deletion from, the National List of Approved and Prohibited Substances. The NOSB may 

also make recommendations to add, remove, or modify annotations restricting the use of 

such listed materials.

• Changes to annotation or classification of materials

The NOSB may request to review an existing substance on the National List without a new 

petition when they have justification to support a revision of the annotation or 

reclassification of the substance. This may happen as a result of the sunset review process, 

or as new information is provided in a Technical Review, or from public comment. 

• Recommendation for modification of existing standards or new standards 

The NOP may request that the NOSB develop recommendations for new or existing 

standards. The request should be in writing and include a statement of the problem to be 

addressed, background, including the current policy or situation, statutory/regulatory 

authority, legal context, and desired timeframe for receiving the recommendation. The 

request will be posted on the NOP web site.

• Advice on NOP policy and interpretation of standards

The NOSB may provide comments on guidance or policy memos included in the Program 

Handbook, or may also make recommendations for new guidance or policies.

• Compliance and Enforcement 

The NOP is responsible for compliance and enforcement. The NOP welcomes NOSB input on 

standards, but NOSB involvement in active investigations or enforcement actions is not 

appropriate. When timely and appropriate, the NOP reports to the NOSB the status of

enforcement actions and also posts the status on the NOP web site.

• Management Review

The NOSB may review the quality management system and internal audits to ensure that 

the NOP is managed effectively and efficiently. For example, the NOSB may be asked for 

informal feedback or to work on specific work agenda items that relate to the development 

or implementation of audit corrective actions. 

G. Designated Federal Officer 

FACA and its implementing regulations (5 U.S.C. App. 2) govern the roles and responsibilities of 

NOSB management including meeting coordination and facilitation. The Designated Federal 

Officer (DFO) is the individual designated to implement advisory committee procedures. The 

AMS/NOP Deputy Administrator is the DFO for the NOSB. 

The NOP Deputy Administrator or designee acts as the Designated Federal Officer (DFO) during 

public meetings of the NOSB and meetings of the Executive Subcommittee. The Advisory 

Committee Specialist (ACS) or designee acts as the DFO for all other NOSB Subcommittee 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 66/302
meetings. The DFO holds the authority to chair meetings when directed to do so by the official 

to whom the advisory committee reports. 

The DFO’s duties include but are not limited to: 

• Approving and calling the meeting of the NOSB

• Approving the semi-annual meeting agenda

• Attending the semi-annual meetings

• Adjourning the meetings when such adjournment is in the public interest

H. Advisory Committee Specialist 

The Advisory Committee Specialist (ACS) is an NOP staff member who is assigned to support the 

NOSB. The Advisory Committee Specialist prepares the Advisory Committee’s and 

Subcommittees’ meeting agendas and notes, and attends all meetings. The position of Advisory 

Committee Specialist (formerly called Executive Director) was added in 2005 to facilitate 

communication and collaboration between the NOP and the NOSB. Advisory Committee 

Specialist duties include but are not limited to:

• Ensuring that all FACA and OFPA requirements are implemented 

• Managing calendars and work agendas to facilitate Subcommittee and NOSB activities

• Arranging, facilitating, and documenting the NOSB Subcommittee conference calls

• Ensuring NOSB members have all necessary materials and information to provide informed, 

structured and timely recommendations to the NOP 

• Conducting meeting planning activities for the semi-annual NOSB meetings, including 

preparation of Federal Register notices and press releases, and facilitation of public 

comments 

• Coordinating the NOSB nomination and chartering process

• Facilitating training of NOSB members

• Managing information reporting and communication between the NOSB and NOP

I. ADDITIONAL ADMINISTRATIVE ITEMS 

• Official to whom the Committee Reports

The NOSB shall provide recommendations to the USDA Secretary through the Designated 

Federal Officer, the Agricultural Marketing Service’s NOP Deputy Administrator.

• Staff Support

The NOP shall provide administrative support to the NOSB through the work of an Advisory 

Committee Specialist, who is a permanent NOP staff member. The NOP may also provide 

technical support to the NOSB based on need and available resources. 

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• Estimated Number and Frequency of Meetings

The NOSB meets approximately twice per year for public meetings. Most NOSB 

Subcommittees meet approximately twice a month by conference call. 

• Recordkeeping

Records of the NOSB shall be handled in accordance with General Records Schedule 26, Item 

2 or other approved agency records disposition schedule. These records shall be available 

for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552. 

Information about the NOSB is available online at: 

http://www.ams.usda.gov/rules-regulations/organic/nosb

While meeting transcripts are not required under FACA, the NOP provides transcripts or 

meeting notes to support the transparency of NOSB meetings and to support subsequent 

rulemaking activities. Minutes of each NOSB meeting, as approved by the DFO and the 

NOSB Chair and Secretary, shall contain a record of the persons present, a complete and 

accurate description of matters discussed and conclusions , and the outcome of voting. 

FACA requires (5 U.S.C. App. Section 10 (b) ): “Subject to section 552 of title 5, United States 

Code, the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, 

agenda, or other documents which were made available to or prepared for or by each 

advisory committee shall be available for public inspection and copying at a single location 

in the offices of the advisory committee or the agency to which the advisory committee 

reports until the advisory committee ceases to exist.”

Any request for FACA records must be made to the NOP.

While requests for FACA Board records do not have to go through the formal FOIA request 

process, those records must be reviewed by AMS/NOP before release, to determine 

whether any FOIA exemptions apply (e.g., personal information, business proprietary 

information). In addition, OFPA itself requires that no confidential business information be 

released, so emails and documents need to be reviewed before release to ensure that this 

requirement is met. 

• Freedom of Information Act (FOIA; 5 U.S.C. 552). Under this Act, the public may request 

documents and other information pertaining to USDA actions. NOSB communications with 

USDA (including email) are subject to these requests, with limited exemptions. Some USDA 

information is routinely exempt from disclosure in or otherwise protected from disclosure 

by statute, Executive Order or regulation; is designated as confidential by the agency or 

program; or has not actually been disseminated to the general public and is not authorized 

to be made available to the public upon request. When there is a FOIA request for 

information, the USDA will review all relevant information and determine what qualifies for 

release, then provide it to the requestor. 

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J. PROFESSIONAL AND ETHICAL STANDARDS 

As appointees of the Secretary, NOSB members must maintain high professional and 

ethical standards both within and outside of the NOSB. Areas of particular concern 

include professional conduct and conflict of interest. 

1) NOSB Member Professional Conduct Standards

NOSB members shall:

• Observe ethical principles above private gain in the service of public trust. 

• Put forth an honest effort in the performance of their NOSB duties. 

• Make no commitments or promises of any kind purporting to bind the Government. 

• Act impartially and not give preferential treatment to any organization or individual. 

• Participate in meetings – Subcommittee conference calls as well as semi-annual 

meetings 

• Serve on Subcommittees as assigned - Each member must be willing to serve on 

Subcommittees as assigned by the NOSB Chair, and to participate in the work of 

those Subcommittees. 

• Be informed about NOSB business - NOSB members are expected to seek and study 

the information needed to make reasoned decisions and/or recommendations on all 

business brought before the NOSB. 

To maintain the highest levels of honesty, integrity, and ethical conduct, no NOSB 

member shall participate in any “specific party matters” (i.e., matters that are narrowly 

focused and typically involve specific transactions between identified parties) such as a 

lease, license, permit, contract, claim, grant, agreement, or related litigation with the 

Department in which the member has a direct or indirect financial interest. This includes 

the requirement for NOSB members to immediately disclose to the NOP’s Advisory 

Board Specialist any specific party matter in which the member’s immediate family, 

relatives, business partners, or employer would be directly seeking to financially benefit 

from the Board’s recommendations. 

 

All members receive ethics training annually to identify and avoid any actions that 

would cause the public to question the integrity of the NOSB’s advice and 

recommendations. The provisions of these paragraphs are not meant to exhaustively 

cover all Federal ethics laws and do not affect any other statutory or regulatory 

obligations to which advisory committee members are subject.

2) Additional Standards of Conduct

NOSB members should adhere to the following basic “standards of conduct” while in 

government service: 

• Do not accept improper gifts (from those seeking actions from the Board). 

• Do not use board appointments for private gain. 

• Do not misuse internal non-public government information. 

• Do not use government property and time improperly. 

• Do not accept compensation for teaching, speaking, and writing related to your 

board duties. 

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• Do not engage in partisan political activities while performing your board duties or 

while in a federal building.

• Alert the NOSB designated federal officer (DFO) if you or your employer enters into 

a lawsuit against USDA or its sub-agencies.

• Refrain from sharing working documents with the public. Working documents are 

defined as information that a board member gains by reason of participation in the 

NOSB and that he/she knows, or reasonably should know, has not been made 

available to the general public: e.g. is not on the NOP or other public websites, or is 

a draft document under development by an NOSB Subcommittee.

• Do not circulate draft Subcommittee documents until they are finalized and publicly 

available to all on the AMS/NOP website. 

• Use a professional, respectful tone in NOSB email correspondence; remember that 

all correspondence with government officials is subject to FOIA requests.

• To the maximum extent possible, NOSB members should speak with one voice. 

Although there may be disagreements within NOSB Subcommittees or working 

group sessions, once NOSB members leave the session, they have the responsibility 

to support the integrity of the process, whether or not they agree with the final 

outcome. While NOSB members retain the right to express minority opinions, the 

public airing of dissension could strain interpersonal relationships and create 

distrust and conflict among NOSB members. Such stresses could undermine the 

NOSB’s ability to effectively carry out its role as a governmental advisory board. 

3) Failure to participate 

The NOSB typically has a heavy work load and thus active participation by all 15 

members is essential to carry out the mandates in OFPA. When one or more 

members fail to actively participate in Board work the entire NOSB and the organic 

community is negatively impacted. If a Board member finds that s/he cannot 

consistently attend Subcommittee meetings, take on work assignments, complete 

Subcommittee work in a timely manner, or cannot attend the twice-yearly public 

meetings and public comment listening sessions, the NOSB Chair shall discuss the 

matter with the Board member, bring the concerns to the attention of the Executive 

Subcommittee, and if necessary encourage the Board member to resign.

K. DECLARATION OF INTERESTS/Conflict of Interest

NOSB members are classified as representatives under the Federal Advisory Committee Act 

(FACA). Each representative is appointed to articulate the viewpoints and interests of a 

particular interest group. The Organic Foods Production Act (OFPA) prescribes these interest 

groups, which include farmers/growers, handlers, certifiers, environmentalists/conservationists, 

scientists, consumers and public interest groups, and retailers. Representatives are appointed to 

speak in “we” terms, serving as the voice of the group represented (e.g., “we farmers/growers 

believe...”). As such, NOSB members are not expected to provide independent expert advice, 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 70/302
but rather advice based on the interests of the groups served. 

 

NOSB members represent the interests of a particular group. As such, many of the interests are 

acceptable interests. An interest is acceptable if it is carried out on behalf of a represented 

group, and if a Board member receives no disproportionate benefit from expressing the interest. 

True conflicts of interest arise when an interest: 

• Directly and disproportionally benefits you or a person associated with that member; 

• Could impair your objectivity in representing your group; or 

• Has the potential to create an unfair competitive advantage. 

The appearance of a personal conflict and loss of impartiality, while not a true conflict, must be 

considered when conducting NOSB business. 

Declarations of Interest/Conflicts of Interest Procedures 

Board members are appointed in part because of their interests. As such, each NOSB member

needs to actively consider their interests with respect to topics being considered by the Board, 

and identify whether these interests would create appearance problems. This consideration 

should occur at two specific points during the Board’s work on a particular topic. The first 

consideration should occur at the Subcommittee level, when a Subcommittee begins work on 

material or topic. The second is when a discussion document or proposal advances from the 

Subcommittee to the full Board for consideration. 

At the Subcommittee Level

NOSB members represent the diverse interests of a broad stakeholder community, and make 

recommendations that may have wide-reaching regulatory impacts across all of these interest 

groups. As such, NOSB member actions are carefully scrutinized. 

Given this, the NOP has provided the following guidelines for NOSB members working at the 

Subcommittee level: 

• Avoid leading projects for which you could reasonably be viewed by others as having a particular 

interest that would hinder your ability to objectively and fairly represent broader group 

interests, and to allow other members to represent theirs. If leading a project would likely lead 

others to believe you are “self-dealing” to benefit yourself or someone close to you, you should 

refrain from leading. 

• If you feel you may have an appearance problem or conflict of interest, you should inform the 

DFO that a conflict may exist, and describe the nature of that conflict. You should also tell the 

subcommittee impacted that you may have a conflict; sharing as much or as little about the 

nature of the conflict with other board members as you wish. After this declaration, you may 

continue to contribute to the discussion on the topic. As long as it is known there is a conflict of 

interest, the conflict does not preclude the member from contributing his or her input to the 

subcommittee. 

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• If you are uncertain as to whether an interest constitutes an appearance problem or a true 

conflict, then contact the DFOto discuss it. In this case, the NOP, working with the USDA office of 

ethics as needed, will make the determination about whether a problem exists.

At the Full Board Level

Once discussion documents and proposals are posted for public comment, each NOSB member is to 

review the documents across all Subcommittees, and research any potential conflicts of interest due 

to organizational affiliation or relationships. 

The following procedures will take place at the Board level: 

1. Approximately 2-4 weeks before the meeting, the NOP’s DFO will provide a matrix to all 

NOSB members that lists the items being considered at the meeting. 

2. If you determine that you do have a conflict of interest, use the matrix to disclose that 

information and to declare a recusal from voting on the item(s). 

3. If you are not sure whether an interest is acceptable or poses a problem, or if you are 

uncertain whether recusal is needed, contact the NOP DFO to discuss. The NOP – working 

with the USDA office of ethics as needed - will make the determination about whether a 

conflict of interest exists, and will instruct the member accordingly as to whether to vote or 

not. 

4. Return your completed matrix approximately one week before the board meeting. The NOP

will then use these to compile a list of all recusals for the meeting. 

5. At the meeting, at the beginning of each subcommittee session or at a time designated at 

the discretion of the board chair, the DFO will state: “the following board members have a 

conflict of interest with the following documents, and will not be voting: e.g. Bob has a 

conflict and will recuse himself from the proposals CleanGreenA and GreatChemB

(etcetera).” 

6. Once the DFO completes listing the recusals, the NOSB Subcommittee chair leading the 

session may invite additional information from members on a voluntary basis, with a 

statement such as: “if Board members wish to disclose information about their conflict, or 

any other information about their interests, they are welcome to do so at this time.” This is 

to be stated as a general and voluntary invitation; no specific NOSB member is to be called 

on. 

7. For any documents deferred to the last day of the meeting, the DFO will repeat the 

declaration of statement above at the start of the voting session for each subcommittee. 

When it is time to vote, the NOSB member recusing her/his self should state “recuse” when 

it is his or her time to vote. 

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IV. SUBCOMMITTEES 

Subcommittees play an important role in administering the NOSB’s responsibilities to make 

informed decisions. The Subcommittees are responsible for conducting research and analyses, 

and drafting proposals for consideration by the full NOSB. No Subcommittees are authorized to 

act in place of the NOSB. Subcommittees are either standing or ad hoc

 

A. STANDING SUBCOMMITTEES 

The current standing Subcommittees are: 

• Executive (ES)

• Certification, Accreditation, and Compliance (CACS)

• Crops (CS)

• Handling (HS)

• Livestock (including Aquaculture) (LS)

• Materials (including GMOs) (MS)

• Policy Development (PDS)

Executive Subcommittee (ES)

The Executive Subcommittee of the NOSB shall be comprised of the Chair, Vice Chair, 

Secretary, and the Chairs of each of the standing Subcommittees. The Executive 

Subcommittee provides overall coordination for the NOSB including finalizing the NOSB 

meeting agenda and NOSB work agendas. 

Certification, Accreditation, and Compliance Subcommittee (CACS) 

The CACS drafts proposals for consideration by the NOSB to provide guidance, clarification, 

or proposed standards for the certification, accreditation and compliance sections of the 

USDA organic regulations and OFPA.

 

Crops Subcommittee (CS)

The CS drafts proposals for consideration by the NOSB to provide guidance, clarification, or 

proposed standards for the crop production sections of the USDA organic regulations and 

OFPA. The CS reviews substances under sunset review and petitions for addition to, or 

removal from the National List of Allowed and Prohibited Substances. The CS reviews

technical reports (TRs), technical advisory panel reports (TAPs), and public comments 

concerning materials used for organic crop production to draft their proposals.

 

Handling Subcommittee (HS) 

The Handling Subcommittee drafts proposals for consideration by the NOSB to provide 

guidance, clarification, or proposed standards for the handling and labeling sections of the 

USDA organic regulations and OFPA. The HS reviews substances under sunset review and 

petitions for addition to or removal from the National List of Allowed and Prohibited 

Substances. The HS reviews technical reports (TRs), technical advisory panel reports (TAPs), 

and public comments concerning materials used for organic handling to draft their 

proposals. 

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Livestock Subcommittee (including Aquaculture) (LS) 

The LS drafts proposals for consideration by the NOSB to provide guidance, clarification, or 

proposed standards for the livestock and livestock feed sections of the USDA organic 

regulations and OFPA. The LS reviews substances under sunset review and petitions for 

addition to or removal from the National List of Allowed and Prohibited Substances. The LS 

reviews technical reports (TRs), technical advisory panel reports (TAPs), and public 

comments concerning materials used for organic livestock and aquaculture production to 

draft their proposals.

 

Materials Subcommittee (including Genetically Modified Organisms) (MS)

The MS drafts proposals for consideration by the NOSB to provide guidance, clarification, 

or proposed standards for the pertinent National List sections of the USDA organic 

regulations and OFPA. The MS works with the NOP and other NOSB Subcommittees in 

managing the Materials Review Process, which may include determining which 

Subcommittee will conduct a review, as well as tracking technical reports and the status of 

reviews for petitions and sunset materials. The MS also drafts proposals and discussion 

documents regarding the prohibition on the use of Genetically Modified Organisms 

(excluded methods) under the USDA organic regulations. Research Priorities are also a 

critical component of the annual work agenda of the MS.

In addition to a Chair, who will be appointed by the NOSB Chair, the MS shall include in its 

membership a representative from each of the Livestock, Crops, and Handling 

Subcommittees. 

Policy Development Subcommittee (PDS) 

The Policy Development Subcommittee provides clarification and proposed changes for 

NOSB internal policies, and procedures as needed, in collaboration with the NOP. The PDS, 

in collaboration with the NOP, also updates and revises the NOSB Policy and Procedures 

Manual and the Member Guide. 

B. AD HOC SUBCOMMITTEES

At the discretion of the NOSB Chair, and with approval of the Executive Subcommittee and 

the DFO, ad hoc NOSB Subcommittees may be formed to develop policy and guidance on 

specific issues that involve multiple standing Subcommittee jurisdictions, or for issues or 

tasks that are very large and require additional resources to complete. Ad hoc 

Subcommittees must be comprised of current NOSB members, and may be either a 

combination of two or more standing Subcommittees to form a “joint” Subcommittee, or 

may be a completely new Subcommittee comprised of selected NOSB members from 

various standing Subcommittees. Ad hoc Subcommittees can be dissolved at the 

recommendation of the NOSB chairperson with the approval of the Executive 

Subcommittee. Ad hoc Subcommittee Chairpersons are non-voting members of the 

Executive Committee.

C. SUBCOMMITTEE MEETINGS 

Subcommittees generally hold meetings once or twice a month via telephone 

conference calls. Calls are scheduled well in advance on a regular reoccurring interval. 

Additional meetings can be held if a Subcommittee requests additional time and the 

NOP agrees to provide the resources to support the additional meeting. A majority of 

the members of a Subcommittee shall constitute a quorum for the purpose of 

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conducting Subcommittee business. 

D. TASK FORCES 

The NOSB may request the establishment of a Task Force to explore specific issues or 

concerns relevant to the organic community and industry, and present to the NOSB

draft proposals, discussion documents, or reports. Each task force shall:

• Have a specific work agenda approved by the NOP 

• Have a clearly articulated project deliverable 

• Include at least one current member of the NOSB

• Record and maintain meeting or conference call minutes, made available to the 

NOSB and the NOP 

• Submit a final report to the NOSB

• Disband when the NOP notifies the Task Force that its work has concluded or when 

the task force is no longer necessary. 

• Have a specific start and end date, which may be extended by the Executive 

Subcommittee, with concurrence by NOP. 

E. DUTIES OF SUBCOMMITTEE CHAIRS AND VICE CHAIRS

Subcommittee Chair duties:

• Appoint a Subcommittee Vice Chair in consultation with Board Chair

• Consult with the Board Chair regarding Subcommittee appointments

• Schedule Subcommittee meetings as needed 

• Draft Subcommittee meeting agendas and work agendas in consultation with 

Subcommittee members, the Executive Committee, and NOP staff 

• Convene and preside over Subcommittee meetings 

• Ensure Subcommittee meeting notes are recorded

• Ensure that Subcommittee meeting notes are reviewed for accuracy 

• Report actions of the Subcommittee to the Executive Subcommittee and Board 

• Serve as mentor/trainer for new Subcommittee Chair during transition periods

• Designate a liaison to the Materials Subcommittee to collect, compile and present 

the research priorities proposals. 

Subcommittee Vice Chair duties: 

• Provide support in developing and completing Subcommittee work agendas

• Assist in reviewing Subcommittee meeting notes for accuracy

• Represent the Chair in the event of the Chair’s absence

• The Vice Chairs of the Crops, Livestock and Handling Subcommittees will serve on 

the Materials Subcommittee as liaisons for reviewing all petitioned substances.

F. TRANSITION OF SUBCOMMITTEE CHAIRS, VICE CHAIRS, AND MEMBERS (NEW AND 

CONTINUING)

Subcommittee Chairs shall be appointed to serve annually by the Chair of the Board. 

Vice Chairs and Subcommittee members shall be appointed by their respective 

Subcommittee Chair in conjunction with the NOSB Chair. The annual Subcommittee 

term shall be concurrent with the one-year term established by the Secretary (beginning 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 75/302
on January 24 and ending the following January 23). Newly appointed Chairs, Vice Chairs 

and Subcommittee members will assume their positions at the beginning of the new 

term, after a period of orientation and mentorship provided by the outgoing Chair, Vice 

Chair, and members.

To avoid disruption in the quality and volume of work produced by the NOSB, the 

following procedures will be observed: 

After the election of NOSB Officers at the Fall Meeting:

1. The new NOSB Chair takes Office 

Immediately after the election, on the final day of the NOSB meeting, the new Chair 

takes office. 

 

2. Appointment of Subcommittee Chairs 

The Board Chair appoints Subcommittee Chairs preferably chosen from members 

with at least one year of NOSB experience.

3. Appointment of Subcommittee Vice Chair

Vice Chairs shall be appointed by the incoming Subcommittee Chair, in conjunction 

with the Board Chair. 

4. Timeframe for Appointments 

Subcommittee Chairs shall be appointed by the NOSB Chair and seated within a 

reasonable time after the newly elected NOSB Chair takes office (or continues in 

office), and Vice Chairs shall be appointed by Subcommittee Chairs as soon as 

possible after that. 

5. Review of Subcommittee Files 

New Subcommittee Chairs should review all work agenda items and active files 

involving Subcommittee work

 

6. Mentorship Period 

The incoming Chair and Vice Chair of each Subcommittee shall participate in an 

orientation and mentorship period with the outgoing Chair and Vice Chair of their 

Subcommittee until seated in their positions at the beginning of the new term on 

January 24. The Board Chair, to facilitate an effective transition for new members of 

the Board and ensure effective participation in Committee and Board deliberations, 

shall ask incoming Board members to identify a mentor from existing Board 

members, or, if the Board member prefers, the Board Chair shall assign a mentor. 

7. Appointment of New NOSB Members: 

The Board Chair will appoint each new NOSB member to appropriate 

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Subcommittees as soon as possible, so that on January 24 all Subcommittees are in 

place. The NOSB Chair will consult with outgoing and incoming Subcommittee Chairs 

and other Board officers, with due consideration of the members interest, expertise, 

and background, as well as the composition and needs of the new Board and scope 

of Subcommittee work agendas. Once appointed, incoming Subcommittee members 

shall be included in all email communication pertaining to the Subcommittees on 

which they serve.

Changing Subcommittee Appointments

Board members who would like to join or leave a Subcommittee shall submit a request 

to the Board Chair. If the request does not alter the preferred number of Subcommittee 

members, in the range of five to seven, the expectation is that the request will be 

approved, unless the Board Chair finds that such a change will interfere with the 

functioning of the Subcommittee or the Board. The Chair’s determination should be 

made in consultation with Subcommittee Chairs and the Executive Subcommittee.

Filling a Subcommittee Chair and/or Vice Chair vacancy

If a Subcommittee Chair position becomes vacant, the Subcommittee Vice Chair shall 

assume the position as Chair and the new Subcommittee Chair shall appoint a new Vice 

Chair in accordance with the consultation procedures cited above.

G. PROCEDURES FOR COMPLETING SUBCOMMITTEE PROPOSALS AND DISCUSSION 

DOCUMENTS

1. Development of proposals

Each of the NOSB Subcommittees will develop proposals, discussion documents or 

reports based on the current work agenda. 

 

• A Subcommittee drafts a proposal or discussion document based on that 

Subcommittee’s work agenda. 

• By a simple majority, the Subcommittee can vote to pass a proposal or discussion 

document to the full Board for consideration at a subsequent NOSB meeting. In 

order to be considered for a vote during an NOSB meeting, all proposals must be 

voted on by the Subcommittee and submitted to the NOP at least forty five (45) 

days prior to a scheduled NOSB meeting.

• When it is not possible for a Subcommittee, during its regular deliberations on 

conference calls, to reach consensus on a proposed document/recommendation as 

it is being reviewed, and there are substantive irreconcilable differences, a minority 

of the Subcommittee may develop a written minority view for review by all 

members of the Subcommittee. The Subcommittee Chair has the responsibility to 

facilitate the process for the minority view.

A minority view should: 

o Be short and concise, and include reasons for opposing the Subcommittees 

recommendation; 

o Should not include any data or information not introduced on a 

Subcommittee call; 

o Should be submitted in a timely manner, and will not be accepted after the 

Subcommittee has voted on its recommendation; 

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o Will be included as a separate section at the end of the recommendation.

• The NOP will post the proposal or discussion document for public comment. 

• At any point in the process prior to the Board’s vote, a Subcommittee may convene 

and, by a simple majority, vote to withdraw its proposal from consideration by the 

Board. 

• During a subsequent Board meeting, the Subcommittee presents the proposals and 

discussion documents as well as a summary of public comments and other relevant 

information for discussion and consideration by the full Board.

2. Types of Proposals 

 (See Member Guide for examples)

There are several formats for writing proposals and discussion documents, based on 

the subject under review:

o Proposals related to material petitions, sunset reviews, annotation changes, or 

classification changes. 

o Proposals for policy or procedure changes 

o Discussion documents

3. Presenting Subcommittee Proposals and Discussion Documents at NOSB Meetings

NOSB Subcommittees and task forces should follow the outline below when presenting

proposals or discussion documents for consideration by the Board: 

1. Introduction: A brief summary of the issue or statement of the problem. 

2. Background: An explanation with sufficient detail and rationale to support 

the proposal, including reasons why the proposal should be adopted, 

historical context, and the regulatory framework pertinent to the issue. 

3. Proposal: A concise explanation of the recommended action. 

4. Subcommittee Vote: The Subcommittee vote shall be reported. In the case 

of petitions to add materials to the National List, two votes will be reported; 

one for classification of the material as a synthetic or non-synthetic, and the 

other a motion to list. 

5. Public Comment: A brief summary of the public comments

6. Minority View: If applicable, the minority view of a Subcommittee or task 

force member shall be reported. After the Subcommittee's proposal has 

been presented and the motion to adopt has been made, it is usual to allow 

the minority to present their views. The minority report is presented for 

information purposes only. If the Board then determines that the minority 

view has merit, it may send the proposal back to Subcommittee for further 

work, since it would be a substantive change to the proposal as presented. 

H. SUBSTANCE/MATERIALS REVIEW PROCESS

A primary function of the NOSB is “to assist in the development of standards for substances 

to be used in organic production” (OFPA 6518 (a)). “The Board shall develop the proposed 

National List or proposed amendments to the National List for submission to the Secretary 

...” (OFPA 6518(k)). The OFPA also establishes a petition process by which the public can 

request additions or deletions to the National List and also provides for a 5 –year “sunset” 

review by NOSB of all substances on the National List. The Materials Review Process is a 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 78/302
collaborative effort between the NOP and NOSB. Some phases of the review process are 

handled exclusively by NOP and some by the NOSB.

The petition process is open to all. Petitions must be filed in accordance with the most 

recent Federal Register notice instructions (currently January 18, 2007 [72 FR 2167]).

1. Steps in the material review process for a new petition: 

1. NOP receives a petition, reviews it for completeness and eligibility according to OFPA

and the petition guidelines. NOP forwards the petition to the appropriate Subcommittee 

with a courtesy copy to the Materials Subcommittee.

2. Subcommittee (SC) determines if a Technical Review (TR) is needed. 

3. Technical Report is completed and sent to the Subcommittee for review.

4. TR sufficiency is determined by SC, and the TR is posted on the NOSB website by the 

NOP. 

5. SC reviews substance, develops proposal, discusses proposal and votes, and submits for 

posting 45 days prior to public meeting.

6. The NOSB members analyze comments and votes on the proposal at the public meeting. 

7. The NOSB Chair delivers the final recommendations to NOP. 

Step 1: Receipt of Petition 

During this phase the NOP will: 

• Notify the petitioner via letter and/or electronic mail of receipt of the petition. 

• Determine whether the petition is complete and whether the petitioned substance is 

eligible for petition under the Organic Foods Production Act and its implementing 

regulations, and whether subject to other agency authority (e.g. EPA, FDA); 

• NOP documents this review using two checklists.

o OFPA Checklist, NOP 3005-1 

o Petition Checklist, NOP 3005-2 

Ineligible petitions include: 

• Formulated (brand name) products

• Food additive without FDA approval

• Pesticide without EPA tolerance or tolerance exemption

• Requests to add substances already allowed

• Synthetic macronutrient (e.g., NPK) fertilizers

• Materials otherwise prohibited by the USDA organic regulations (e.g., sewage 

sludge, GMOs, etc.)

• Previously petitioned/rejected materials (if no new information is provided)

Upon determination of completeness and eligibility, NOP will: 

• Notify the petitioner, via letter and/or electronic mail, that the petition is complete 

and eligible; 

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• Publish the petition on NOP website; and 

• Notify the NOSB Subcommittee that the substance is being petitioned for addition 

or prohibition from the National List and provide the OFPA and petition checklists.

• NOP is the primary point of contact for any correspondence between NOSB and 

petitioner

Step 2: Determine whether a Third Party Technical Review is required 

During this phase, the applicable NOSB Subcommittee has 60 days to review the petition 

and determine whether a third party technical review is required. This decision is based on 

the following:

• Is there sufficient information in the petition? 

• Can the Subcommittee reasonably research any needed technical information?

• Can sufficient information be obtained from public comment? 

• Does the Subcommittee have the expertise needed to address the questions related 

to the petition? This includes impact on the environment, impact on human health, 

and sustainability and compatibility with organic principles. 

If the Subcommittee decides a Technical Review is needed, the Subcommittee Chair will 

make the request to the National List Manager. The SC may also submit questions for 

specific information based on the OFPA evaluation criteria (7 USC 6817(m)), or suggest 

recommended technical expertise. The NOSB may request more information from the 

petitioner if needed. 

If the Subcommittee decides the Technical Review is not needed, the Subcommittee Chair 

will inform the National List Manager. 

In some cases, the Subcommittee may decide the substance is ineligible for the National List 

without need for a Technical Review. In this case, they will develop a proposal to reject the 

substance at the next NOSB meeting, subject to a full board vote. 

A limited scope or supplemental TR may be appropriate when the petition is to amend an 

existing listing, remove a listing, or for purposes of sunset review. 

Option for a Technical Advisory Panel (TAP)

OFPA states: “The NOSB shall convene technical advisory panels to provide scientific 

evaluation of materials considered for the National List.”(7 USC 6518 (k)(3))

The NOSB has not convened independent Technical Advisory Panels since 2005. Currently 

the NOSB is relying on information within the Technical Reports provided by the NOP and 

public comment to make their final recommendations 

In some cases, NOSB may wish to convene a TAP instead of requesting a TR, for review of 

complex or controversial substances. 

Step 3: Third Party Technical Review 

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During this phase the NOP will:

• Assign a contractor to develop a Technical Review (TR) or Technical Advisory Panel 

(TAP). The third party contractor must have technical expertise relevant to the petition, 

and will use the TR template provided by NOP. 

• Review all TRs or TAP reports before they are distributed to the Subcommittee to 

ensure they meet the requirements of the contract.

• Ensure that TRs/TAP reports are sufficient and complete when they are distributed to 

the Subcommittee 

Third party experts may consist of contractors, or employees of the USDA, such as AMS 

Science and Technology, AMS Agricultural Analytics Division, Agricultural Research Service, 

or other federal agencies with appropriate expertise, as needed. 

Step 4: Technical Review Sufficiency Determination 

During this phase the Subcommittee (Crops, Livestock or Handling) will: 

Review the draft TR to ensure that it:

• Is consistent in format, level of detail and tone

• Is technically objective and free from opinions or conjecture 

• Is written in a style appropriate for non-technical readers (e.g. free of technical 

jargon)

• Is prepared using a well-defined and consistent procedure consisting of 

information gathering, information synthesis and document preparation, and 

quality assurance 

• Is based on the best available information that can be obtained within the 

designated time frame

• Is thoroughly supported using literature citations

• Addresses all evaluation questions in the TR template

The Subcommittee chair will notify the NOP, within 60 days of receiving the TR, that the 

TR is sufficient. If the TR is not found sufficient, the Subcommittee must provide the 

NOP with an explanation of why, including a request for additional information or 

improvements.

If necessary, the NOP will seek improvements or supplemental information from the 

contractor.

Once the Technical Reports are deemed sufficient, the NOP will post on the NOP 

website.

Step 5: Review by the Subcommittee (Crops, Livestock or Handling) 

During this phase the Subcommittee conducting the review will: 

• Read the review, along with the submitted petition, and any additional information 

available, such as literature referenced in the Technical Review, personal 

knowledge, and recommendations of a contracted panel of experts when utilized. 

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• Subcommittee members will prepare a written review the substance according to 

the OFPA criteria. 

• After discussion, the Subcommittee will vote on classification (e.g., synthetic, 

nonsynthetic, agricultural) for substances not previously classified, and vote on a 

proposed action (e.g., add to National List, remove, or amend)

• The review, including record of votes, will be finalized as a proposal for the next 

meeting. 

• All proposals must be submitted to NOP for posting 45 days before the public 

meeting date. 

Step 6: Action by Full NOSB 

During this phase the NOP will: 

• Publish the proposals on the NOP website and provide a minimum of 30 days of 

written public comment on the proposal prior to the public NOSB business meeting. 

• Include sufficient time on the agenda at the NOSB meeting for the Board to discuss 

the proposal, listen to public comments, and make a recommendation. 

At the NOSB meeting: 

• The Subcommittee Chair or delegated lead reviewer for each Subcommittee will 

present the proposals at the NOSB meeting. The proposals are to be presented in 

the form of a seconded motion coming from the subcommittee, and the Chair will 

open the motion for discussion. After discussion board members will vote on the 

motion. 

• Voting may be by show of hands, roll call, or by use of modern voting devices.

• The NOSB Secretary will record the votes of each NOSB member and the Chair will 

announce whether or not the motion passed. 

2. Changes to annotations or classification of materials.

The NOSB may request to review an existing substance on the National List without a new 

petition when they have justification to support a revision of the annotation or 

reclassification of the substance. This may happen as a result of the sunset review process, 

or based on new information provided in a Technical Review, or from public comment. The 

following procedure should be followed:

• The Subcommittee sends a written request for a new work agenda item to the 

Executive Subcommittee.

• The request should include a summary of the issue, brief justification for the 

change, and resources in hand or needed for the project. 

• The ES considers the request and determines if it should go forward. 

• NOP reviews the item for possible addition to the work agenda, and may 

propose to add to a future meeting schedule depending on NOSB workload.

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• The Subcommittee develops a proposal for consideration that is separate from 

the sunset review of the substance. NOP will then consider rulemaking action in 

a timely manner, without constraints due to the sunset timeline. 

3. Additional considerations concerning Technical Reviews

Basic principles that should be considered when consulting with a third party expert: 

• A Subcommittee cannot proceed with a recommendation to list a material if it is 

determined that there is insufficient valid scientific information on that material’s 

impact on the environment, human health and its compatibility with organic principles. 

• The decision to request a third party expert needs to be made independently of the 

availability of funds. If there is a lack of funding to secure third party expert advice, the 

Subcommittee has the option to place the review of new petitions on hold. 

• The Subcommittee makes a determination on the completeness of the petition and 

whether a Technical Review is needed. 

• The decision to define the expertise of the third party expert is the responsibility of the 

Subcommittee reviewing the material or issue. 

• To incorporate a diversity of opinions and to minimize the risk of bias, a Subcommittee 

may seek information from a range of technical experts (individuals or institutions). The 

Subcommittee may also ask questions in their posted proposals, in order to gain needed 

information from the public. 

• The NOP will seek Technical Reviews from a range of experts. The name of the 

contracted party will appear on the Technical Review.· All Federal contracts, including 

those issued by USDA/NOP to Technical Report contractors, are governed by the Federal 

Acquisition Regulations (FAR). The FAR includes a “Subpart 3.11—Preventing Personal 

Conflicts of Interest for Contractor Employees Performing Acquisition Functions,” which 

requires contractors to identify and prevent personal conflicts of interest for their 

covered employees. “Personal conflict of interest” means a situation in which a covered 

employee has a financial interest, personal activity, or relationship that could impair the 

employee’s ability to act impartially and in the best interest of the Government when 

performing under the contract.

Link: https://www.acquisition.gov/far/current/pdf/FAR.pdf

4. Definitions

Technical Review - A report prepared by a third party expert under contract addressing 

the environmental, human, and industrial impact of a petitioned material per the OFPA 

and regulatory evaluation criteria to aid in the thorough evaluation of that material by 

the NOSB.

Technical Advisory Panel (TAP) - Group of third party experts convened by the Board to 

provide a technical review related to a material petition under review by the NOSB. 

V. Prioritization of Petitions 

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Petitions received and deemed eligible and sufficient by the NOP/NOSB will be 

prioritized as follows:

Priority 1: A petition to remove a material presently on the National list that raises 

serious health, environmental, or regulatory concerns, including petitions to reconsider 

previous decisions, will be given the highest priority - Priority 1, above all other 

petitions in the queue of the reviewing Subcommittee (Crops, Handling, or Livestock). 

Priority 2: A petition to remove a material presently on the National list not based on 

serious health, environmental, or regulatory concerns, but based on other new 

information, such as commercial availability status, would be assigned a Priority 2, 

behind Priority 1 petitions, but above any petitions to list materials that are in the queue 

of the reviewing Subcommittee (Crops, Handling, or Livestock). This priority assignment 

would include any removal petitions requesting reconsideration of previous board 

decisions, if the resubmitted petition contains substantive new information to warrant 

reconsideration. 

Priority 3: A petition to add a material to the National List will be considered by the 

reviewing Subcommittee (Crops, Handling, or Livestock) in the chronological order in 

which it was received, and will be designated as Priority 3. 

Priority 4: A petition to reconsider adding a material that had previously been rejected 

by a Board vote would be given the lowest priority - Priority 4, and would go to the 

bottom of the Subcommittee (Crops, Handling, or Livestock) queue of petitioned 

materials. Petitions submitted for reconsideration must contain substantive new 

information to warrant reconsideration.

This prioritization guideline is only that, a guideline. When situations occur beyond the 

control of the reviewing Subcommittee, such as, but not limited to, technical report 

budgetary constraints, or a delay in the delivery of a technical review for a petitioned 

substance, the work agenda may require adjustment by the NOSB and NOP. 

VI. Withdrawal of a petition by a petitioner

A petition may be withdrawn at any point in the process, prior to the vote by 

Subcommittee. Once a Subcommittee develops a proposal, the outcome will be posted 

for public comment and the NOSB will vote at the next public meeting. When a petition 

is withdrawn by the petitioner prior to Subcommittee proposal, the Subcommittee will 

suspend its review and recommendation procedure. Withdrawals will not be accepted 

after the subcommittee votes on a proposal. 

If a petition is re-submitted, the NOSB will review it in the order in which it was 

received. Thus, a re-submitted petition should be considered a new request and will be 

placed at the end of the queue of materials pending review. 

A petitioner has the opportunity to withdraw a petition with the intent of improving it 

(e.g., conducting additional research), and may also voluntarily submit supplemental 

information. 

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VII. Sunset Review Process 

The Organic Foods Production Act of 1990 (OFPA) authorizes a National List of Allowed 

and Prohibited Substances (7 U.S. C. Section 6517). Sections 6517 (e) mandates a Sunset 

Provision as follows: 

“No exception or prohibition in the National list shall be valid unless the National 

Organic Standards Board has reviewed such exemption or prohibition as provided in this 

section within 5 years of such exemption or prohibition being adopted and the Secretary 

has renewed such exemption or prohibition.”

The NOP published a Federal Register notice on Sept. 16, 2013 (78 FR 56811) describing 

current procedures for sunset review. Through the sunset review process, the NOSB can 

recommend to USDA the removal of substances based on adverse impact on human 

health, the environment, or other criteria under the Organic Foods Production Act 

(OFPA). If upon review the NOSB believes the substance no longer fits the criteria for an 

exemption or prohibition, the NOSB can recommend (by a decisive two-thirds vote, 7 

USC Section 6158 (i)) to remove the substance from the National List. After the NOSB 

has completed this "sunset" review, the USDA must renew or remove the substances on 

the National List to complete the process. All substances under sunset review will be 

considered over two NOSB meetings, to provide ample opportunity for public notice and 

comment. The NOSB observes the following procedure. 

A. Steps in the Sunset Review Process (See Member Guide for forms used in these steps.) 

Step 1: The NOSB Subcommittees submit the initial Sunset List Summary for 

posting which may include requests for specific information. The NOP posts the 

list as well as the NOSB Meeting Announcement in the Federal Register which 

invites comments, at least 30 days prior to the first public meeting on these 

sunset substances.

Step 2: The public submits written comments, which are analyzed by 

Subcommittees. 

Step 3 (Public Meeting #1): Subcommittees summarize background and public 

comment & receive oral comment.

Step 4: Subcommittees analyze written and oral comments from Meeting #1 

and prepare a Preliminary Review that includes a motion to remove the 

substance from the National List. The NOP publishes the next meeting 

announcement in the Federal Register, inviting comment on the Preliminary 

Reviews, which are posted on the NOP website. 

Step 5: Written public comments submitted and analyzed by Subcommittees. 

Step 6 (Public Meeting #2): Subcommittees present Preliminary Review, 

receive oral comment, and discuss the proposal with the full Board. When 

presented to the full NOSB, reviews will contain a motion and second taken in 

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Subcommittee. Motions for removal based on the Preliminary Review are voted 

on by the full Board, and require a decisive two-thirds (2/3) majority to pass.

o At Meeting #2, the NOSB completes the Sunset Review and submits the 

final documents to the NOP. 

Step 7: AMS reviews the NOSB Sunset Review and considers rulemaking action 

for any recommended removals. This will include a proposed rule open for 

public comment before a final rule amendment is published. 

Step 8: AMS issues Federal Register Notice announcing renewal of applicable 

substances. 

Note: this is a regulatory process for determining whether materials already approved 

or prohibited on the National List should be removed. Due to regulatory process 

constraints, it is not possible to modify existing listings, add new uses of a listed 

substance during sunset review, or change annotations. If there is a need to consider 

changing an annotation or re-classifying a material, a subcommittee may request to 

develop a separate proposal that will be reviewed separately from the sunset review 

process. Decisions made through the Sunset review should be transparent, nonarbitrary, based on the best current information and in the interest of the organic 

community and public at large.

VIII. NOSB PROCEDURES

A. BOARD MEETINGS 

All Board meetings, assembled for the purpose of making recommendations to the NOP, are 

subject to FACA (see appendix B for FACA facts) and as such must be open to the public and 

must meet public notification requirements. Not all meetings are subject to FACA and do not 

require public notification. Examples of these exempted meetings include: Subcommittee calls, 

assemblies for completing work, planning retreats, training or sharing information. The date and 

location of in-person Board Meetings, currently held twice each year in spring and fall, will to 

the extent possible, be set at the mutual scheduling convenience of the NOSB and the NOP.

B. CONDUCTING BUSINESS

NOSB public meetings in brief:

• Approximately 3 days long depending on workload

• Meetings are held in various venues across the country to allow for participation by 

stakeholders that otherwise may not be able to attend due to travel constraints 

• A typical meeting agenda includes presentations by the NOP, presentations of proposals and

discussion documents by the NOSB Subcommittees, discussion time and votes on each 

proposal, public comment, NOSB officer elections, and a review of work agendas 

Quorum: As specified in OFPA, a majority of the members of the NOSB shall constitute a 

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quorum for the purpose of conducting business. (7 USC 6518 (h)). In cases of a medical situation 

preventing attendance in person, a virtual presence is permitted. 

Decisive votes: As specified in OFPA, two-thirds (2/3) of the votes cast at a meeting of the NOSB 

at which a quorum is present shall be decisive of any motion (7 USC Section 6518(i)). All 

abstentions will be recorded as such and will not be included as part of the total vote cast in 

case of decisive votes. Similarly, all NOSB members who recuse themselves due to conflicts of 

interest, or are absent, shall be recorded as such and their votes will not be counted towards 

the total number of votes cast. Both abstentions and recusals will be considered in order to 

establish a quorum.

Calculation of Decisive Votes

# Votes Cast # Recusals and 

Abstentions 2/3 Majority*

15 0 10

14 1 10

13 2 9

12 3 8

11 4 8

10 5 7

9 6 6

8 7 6

C. PARLIAMENTARY PROCEDURES

The NOSB adopted the use of Robert’s Rules of Order in March 1992, but modified its use as 

only a non-mandatory guide in May 1993. Roberts Rules may be adapted to meet the special 

requirements of a group. Because the NOSB is also subject to the OFPA, FACA and USDA, a 

designated NOP staff member may act as an informal Parliamentarian to advise the Chair.

D. NOSB DELIBERATIONS AND RECOMMENDATIONS

Board actions include but are not limited to: adoption of a proposal as presented by the 

Subcommittee, non-substantive amendments* and then adoption of a proposal, rejection of a 

proposal, or referral of the proposal back to Subcommittee for further development. 

* Substantive vs. non-substantive amendments. 

The following criteria shall be considered when determining if a proposal will be amended at the 

NOSB meeting, or must be referred back to Subcommittee and resubmitted for the next Board 

meeting. The DFO or designee will determine whether a proposed amendment to a proposal is 

substantive. 

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• The extent to which a reasonable person affected by the recommendation would have 

understood that the published proposal would affect his or her interests

• The extent to which the subject of the recommendation or the issues determined in it are 

substantially different from the subject or issues involved in the proposal

• The extent to which the effects of the recommendation differ from the effects of the 

proposal

Procedure for submitting final recommendations to NOP

Within 30 days after the completion of the NOSB meeting all final recommendations must be 

submitted to the NOP using the following procedure:

Each proposal lead prepares the following documents: 

o A recommendation cover sheet (See Member Guide). The cover sheet should 

contain all appropriate information, including the vote recorded at the meeting. 

(The NOP can provide the voting record)

o The proposal that was voted on at the meeting 

The proposal leads will forward the documents to the appropriate Subcommittee Chair 

who will review them for accuracy and completeness, sign and date them, and then 

forward them to the Board Chair and the DFO/ACS.

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 pre-meeting electronic webinar or at the in-person NOSB meeting. 

Before Public Meetings:

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:

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• 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.

• 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.

• 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.

F. ELECTION OF OFFICERS 

Nominations

• Any NOSB member is eligible for consideration for any officer position. 

• An NOSB member may self-nominate or may be nominated by another member of the 

NOSB. 

• Should the Chair, Vice Chair, or Secretary resign or fail to serve the full term, the Executive 

Subcommittee shall appoint an interim officer. The interim officer shall serve in that 

capacity until the next regularly scheduled meeting of the NOSB, during which an election 

will be held to fill the remainder of the term. 

• Members may serve more than one term in any officer position.

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Voting schedule 

• Officers shall be elected for one-year terms by majority vote at the fall NOSB meeting. 

• Newly elected officers will assume their positions at the conclusion of the fall NOSB 

meeting, and assume the responsibilities thereof at that time. 

• Outgoing NOSB officers will assist the incoming officers with the transition into their new 

roles, to be completed no later than January 23rd of the following year.

Counting of Votes

• Voting will be by secret ballot immediately following nominations for each office

• Ballots for officers will be cast in the following order:

1. Chair

2. Vice Chair

3. Secretary

• Ballots will be counted for one office and the Secretary will announce the tally before the 

next office is opened for nominations. 

• The Secretary and Vice chair will prepare and distribute the ballots, then collect them after 

each vote. 

• The Secretary will tally the votes after each officer nomination and the Chair will verify the 

results. 

• The candidate receiving the greatest number of votes will be elected. 

• In the event of a tie there will be a revote until a nominee obtains a majority. All nominees 

will be included in the revote or may be given the opportunity to withdraw at their 

discretion. 

• Votes will remain confidential, and ballots will be disposed of by the Chair or Secretary. 

G. MISCELLANEOUS PROCEDURES

 

1. Invited Speakers

• Subcommittees, the NOSB or the NOP may identify the need for presentations and 

speakers regarding subjects of interest or concern to be addressed at NOSB meetings. 

• Requests must be made by the NOSB chair to the NOP no less than 60 days prior to the 

target NOSB meeting. 

• Speakers must be approved and invited by the NOP. 

If approved by the NOP, the purpose for the presentation, the subject area and the 

bio/resume of speaker(s) should be circulated via email to the entire Board at least 2 

weeks prior to the Board meeting. 

Current petitioners cannot be invited to be speakers about the topic under discussion, 

unless invited by the NOSB Chair. 

Speakers are expected to disclose any financial interests that he or she has that can be 

reasonably assumed to influence his or her presentation content. 

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2. Surveys Conducted on Behalf of NOSB Subcommittees 

• All surveys, including electronic surveys, conducted on behalf of the NOSB, must be 

approved by the NOSB Executive Subcommittee before they are submitted for approval 

to USDA, and 

• A written report summarizing the results of the survey must be submitted to the full 

Board and the NOP as soon as possible after completion.

IX. REVISIONS TO THE POLICY AND PROCEDURES MANUAL

• The PDS will review the PPM each year and, working in collaboration with the NOP, determine if 

any updates are necessary. 

• Proposed changes will be subject to review and approval by the NOP and the full NOSB. 

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X. APPENDICES 

A. Appendix 1: FOUNDATIONS 

1. NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING 

(NOSB Recommendation Adopted October 17, 2001)

 

1.1 Organic agriculture is an ecological production management system that promotes and 

enhances biodiversity, biological cycles, and soil biological activity. It emphasizes the use of 

management practices in preference to the use of off-farm inputs, taking into account that 

regional conditions require locally adapted systems. These goals are met, where possible, 

through the use of cultural, biological, and mechanical methods, as opposed to using synthetic 

materials to fulfill specific functions within the system. 

1.2 An organic production system is designed to: 

1.2.1 Optimize soil biological activity; 

1.2.2 Maintain long-term fertility; 

1.2.3 Minimize soil erosion; 

1.2.4 Maintain or enhance the genetic and biological diversity of the production system and 

its surroundings; 

1.2.5 Utilize production methods and breeds or varieties that are well adapted to the region; 

1.2.6 Recycle materials of plant and animal origin in order to return nutrients to the land, thus 

minimizing the use of non-renewable resources; 

1.2.7 Minimize pollution of soil, water, and air; and 

1.2.8 Become established on an existing farm or field through a period of conversion 

(transition), during which no prohibited materials are applied and an organic plan is 

implemented. 

1.3 The basis for organic livestock production is the development of a harmonious relationship 

between land, plants, and livestock, and respect for the physiological and behavioral needs of 

livestock. This is achieved by: 

1.3.1 Providing good quality organically grown feed; 

1.3.2 Maintaining appropriate stocking rates; 

1.3.3 Designing husbandry systems adapted to the species' needs; 

1.3.4 Promoting animal health and welfare while minimizing stress; and 

1.3.5 Avoiding the routine use of chemical allopathic veterinary drugs, including antibiotics.

 

1.4 Organic handling practices are based on the following principles: 

1.4.1 Organic processors and handlers implement organic good manufacturing and handling 

practices in order to maintain the integrity and quality of organic products through all 

stages of processing, handling, transport, and storage; 

1.4.2 Organic products are not commingled with non-organic products, except when 

combining organic and non-organic ingredients in finished products which contain less 

than 100% organic ingredients; 

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1.4.3 Organic products and packaging materials used for organic products do not come in 

contact with prohibited materials; 

1.4.4 Proper records, including accurate audit trails, are kept to verify that the integrity of 

organic products is maintained; and 

1.4.5 Organic processors and handlers use practices that minimize environmental degradation 

and consumption of non-renewable resources. Efforts are made to reduce packaging; 

use recycled materials; use cultural and biological pest management strategies; and 

minimize solid, liquid, and airborne emissions. 

1.5 Organic production and handling systems strive to achieve agro-ecosystems that are 

ecologically, socially, and economically sustainable. 

1.6 Organic products are defined by specific production and handling standards that are intrinsic 

to the identification and labeling of such products. 

1.7 Organic standards require that each certified operator must complete, and submit for 

approval by a certifying agent, an organic plan detailing the management of the organic crop, 

livestock, wild harvest, processing, or handling system. The organic plan outlines the 

management practices and inputs that will be used by the operation to comply with organic 

standards. 

1.8 Organic certification is a regulatory system which allows consumers to identify and reward 

operators who meet organic standards. It allows consumers to be confident that organic 

products are produced according to approved management plans in accordance with organic 

standards. Certification requires informed effort on the part of producers and handlers, and 

careful vigilance with consistent, transparent decision making on the part of certifying agents.

 

1.9 Organic production and handling operations must comply with all applicable local, state, and 

federal laws and address food safety concerns adequately. 

1.10 Organic certification, production, and handling systems serve to educate consumers 

regarding the source, quality, and content of organic foods and products. Product labels must 

be truthful regarding product names, claims, and content. 

1.11 Genetic engineering (recombinant and technology) is a synthetic process designed to control 

nature at the molecular level, with the potential for unforeseen consequences. As such, it is 

not compatible with the principles of organic agriculture (either production or handling). 

Genetically engineered/modified organisms (GE/GMOs) and products produced by or through 

the use of genetic engineering are prohibited. 

1.12 Although organic standards prohibit the use of certain materials such as synthetic fertilizers, 

pesticides, and genetically engineered organisms, they cannot ensure that organic products 

are completely free of residues due to background levels in the environment. 

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2. NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE AGRICULTURE AND 

CONSISTENCY WITH ORGANIC FARMING AND HANDLING 

(NOSB Recommendation Adopted April 29, 2004)

 

A significant responsibility of the NOSB is to determine the suitability of materials for use in 

organic production and handling. Among the criteria the Board must consider, OFPA requires the 

NOSB to determine the compatibility of a material with organic practices. The following questions 

were developed by the NOSB to assist in determining the compatibility of materials with organic 

practices. 

 

In order to determine if a substance, its use, and manufacture are compatible with a system of 

sustainable agriculture and consistent with organic farming and handling, and in consideration of 

the NOSB Principles of Organic Production and Handling, the following factors are to be 

considered: 

• Does the substance promote plant and animal health by enhancing the soil’s physical 

chemical, or biological properties? 

• Does use of the substance encourage and enhance preventative techniques including cultural 

and biological methods for management of crop, livestock, and/or handling operations? 

• 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? 

• Does use of the substance have a positive influence on the health, natural behavior, and 

welfare of livestock? 

• Does the substance 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? 

• Is there evidence that the substance is mined, manufactured, or produced through reliance on 

child labor or violations of applicable national 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? 

• Is the use of the substance consistent with other substances historically allowed or disallowed 

in organic production and handling? 

• Would approval of the substance be consistent with international organic regulations and 

guidelines, including Codex? 

• 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? 

• Does use of the substance have a positive impact on biodiversity? 

3. NOSB MEMBER DUTIES

To fulfill their responsibilities, Board members agree to adhere to the following Duties.

Duty of Care 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 94/302
The Duty of Care calls upon a member to participate in the decisions of the Board and to be 

informed as to the data relevant to such decisions. In essence, the Duty of Care requires that a 

member: 

• Be reasonably informed - It is the duty of all Board members to seek and study the 

information needed to make a reasoned decision and/or recommendation on all business 

brought before the Board. The NOP will provide some of that information, but other 

information must be developed from independent sources. 

• Participate in decisions - Board members are bound by responsibility to be active participants 

in decision making. Absence from a meeting is no protection from the responsibility for 

decisions made at the meeting. 

• Make decisions with the care of an ordinary prudent person in a similar position - The law 

requires Board members to exercise the judgment of an ordinary prudent person who may be 

faced with a similar issue. 

Duty of Loyalty 

The Duty of Loyalty requires Board members to exercise their power in the interest of the organic 

community and the public at large, and not in their own interest or the interest of another entity 

or person. In dispatching their Duty of Loyalty, Board members must: 

• Address conflicts of interest - Board members bring to the NOSB particular areas of expertise 

based upon their personal and business interests in organic production and marketing. 

Because Board members may have interests in conflict with those of the public they must be 

conscious of the potential for such conflicts and act with candor and care. Board members 

must abide by the NOSB conflict of interest policy. 

• Recognize corporate opportunity - Before a Board member votes upon an issue in which they 

have a direct financial interest, that Board member must disclose the transaction to the Board 

in sufficient detail and adequate time to enable the Board to act, or decline to act, in regard to 

such transaction. 

Duty of Obedience 

Board members are bound to obey the tenants of the laws and regulations governing organic 

production, processing and marketing. To this effect, Board members must: 

• Act within the requirements of the law - Board members must uphold all state and federal 

statutes, including the Federal Advisory Committee Act (FACA – 5 U.S.C. App. 2 et seq.) 

• Adhere to the responsibilities of the Board as defined by the Organic Foods Production Act of 

1990 

• Adhere to the requirements specified in the NOSB Policy and Procedures Manual

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 95/302
B. Appendix 2 – FACA FACTS

The Federal Advisory Committee Act (FACA) (5 U.S.C. App.2) and its implementing regulations 

(41 CFR Part 101-6.10) govern the creation, operation, and termination of advisory committees 

in the Executive Branch of the Federal Government. The National Organic Standards Board 

(NOSB) is a Department of Agriculture (USDA) non-discretionary advisory committee required by 

the Organic Foods Production Act of 1990, as amended. 

• Advisory committees must be chartered before they can meet or conduct any business. 

Charters must be renewed every two years or they will be terminated under the sunset 

provisions of Section 14 of the FACA, unless otherwise provided by law. 

• Advisory committee meetings are required to be open to the public, with limited exceptions 

as provided for in Section 552b of title 5, United States Code. Meetings not subject to FACA 

include NOSB briefing meetings initiated by the USDA to exchange facts and information, 

member orientation and training, and NOSB Subcommittee meetings. Such meetings are not 

subject to FACA because they are not conducted for the purpose of providing the USDA with 

NOSB advice or recommendations. 

• Designated Federal Officers must approve all meetings and agendas, and attend meetings. 

The Advisory Board Specialist is the NOSB’s Designated Federal Officer. 

• Meeting notices and agendas must be published in the Federal Register to accommodate 

public participation. Although not required by FACA, the NOP strives to: 

o Post a provisional agenda on its web site no later than 90 days before the meeting is 

scheduled to begin 

o Post a final agenda, on its web site, no later than 45 days before the meeting is scheduled 

to begin

o Publish notice of the meeting in the Federal Register no later than 45 days before the 

meeting is scheduled to begin 

• While meeting transcripts are not required under FACA, the NOP provides transcripts or 

meeting notes to support the transparency of Board meetings and to support subsequent 

rulemaking activities. The NOP also issues a short meeting summary, which is required by 

FACA, after each biannual meeting that summarizes the key issues discussed, and the 

outcome of voting. 

• Advisory committee documents must be available for public inspection and copying until the 

committee ceases to exist. 

• Interested persons shall be permitted to attend, appear before, or file statements with any 

advisory committee, subject to reasonable rules or regulations. 

• Additional information may be found at the FACA homepage: 

http://www.gsa.gov/portal/content/100916 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 96/302
 NATIONAL ORGANIC STANDARDS BOARD 

 

POLICY AND PROCEDURES 

MANUAL

 

Adopted October 19, 2002 

Revised August 18, 2005 

Revised March 29, 2007 

Revised November 30, 2007 

Revised May 22, 2008 

Revised November 19, 2008 

Revised May 6, 2009 

Revised November 9, 2009 

Revised April 29, 2010 

Revised October 28, 2010 

Revised April 29, 2011 

Revised December 2, 2011 

Revised April 11, 2012 

Draft Feb. 29, 2016 

This is a comparison document between the currently posted version of 

the NOSB Policy and Procedures Manual (April 11, 2012) and the new 

Feb. 29, 2016 draft. Revisions are shown in strikeout for deletions, and 

with underline for additions or rearranging.

dr

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NATIONAL ORGANIC STANDARDS BOARD (NOSB )

POLICY AND PROCEDURES MANUAL

TABLE OF CONTENTS 

Contents 

INTRODUCTION...................................................................................................................................................6

SECTION I.............................................................................................................................................................6

NOSB VISION STATEMENT .................................................................................................................................. 6

NOSB STATUTORY MISSION................................................................................................................................ 7

“TO ASSIST IN THE DEVELOPMENT OF STANDARDS FOR SUBSTANCES TO BE USED IN ORGANIC PRODUCTION AND TO ADVISE THE 

SECRETARY ON ANY OTHER ASPECTS OF THE IMPLEMENTATION OF THIS TITLE.” (OFPA, SEC 2119 (A)) ........................................ 7

NOSB MISSION STATEMENT................................................................................................................................ 7

DUTIES OF THE BOARD AND OFFICERS ............................................................................................................... 7

Duty of Care ........................................................................................................................................ 14

Duty of Loyalty .................................................................................................................................... 15

Duty of Obedience ............................................................................................................................... 15

MAINTAINING PROFESSIONAL AND ETHICAL STANDARDS............................................................................................... 16

 Professional Conduct........................................................................................................................ 18

 Conflict of Interest ............................................................................................................................ 35

SECTION II .........................................................................................................................................................35

BOARD MEMBER JOB DESCRIPTIONS................................................................................................................ 37

Composition of the Board .................................................................................................................... 37

BOARD MEMBER STANDARDS .......................................................................................................................... 37

CONDUCTING BUSINESS.................................................................................................................................... 38

SECTION III ........................................................................................................................................................38

ROLEOF THE EXECUTIVE DIRECTOR ................................................................................................................ 39

OFFICER RESPONSIBILITIES ............................................................................................................................. 40

ELECTION OF OFFICERS .................................................................................................................................... 41

EXECUTIVE COMMITTEE................................................................................................................................... 43

MEETINGS......................................................................................................................................................... 44

SECTION IV ........................................................................................................................................................44

BOARD COMMITTEES ....................................................................................................................................... 44

COMMITTEE MEETINGS .................................................................................................................................... 45

STANDING COMMITTEES .................................................................................................................................. 45

Certification, Accreditation, and Compliance Committee (CACC).......................................................... 45

Crops Committee (CC).......................................................................................................................... 45

Handling Committee (HC).................................................................................................................... 45

Livestock Committee (LC).................................................................................................................... 45

Materials Committee (MC)................................................................................................................... 46

Policy Development Committee (PDC) ................................................................................................. 46

TASK FORCES.................................................................................................................................................... 46

AD HOC COMMITTEES....................................................................................................................................... 46

SECTION V..........................................................................................................................................................46

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DUTIES OF COMMITTEE CHAIRS ....................................................................................................................... 47

DUTIES OF COMMITTEE VICE-CHAIRS............................................................................................................... 47

PROCEDURES FOR THE TRANSITION OF COMMITTEE CHAIRS .......................................................................... 47

PROCEDURES FOR COMPLETING COMMITTEE RECOMMENDATIONS................................................................ 49

Writing Committee Recommendations ................................................................................................ 50

Presenting Committee Recommendations at NOSB Meetings ............................................................... 52

NOSB-NOP COLLABORATION ............................................................................................................................ 12

SECTION VI ........................................................................................................................................................57

MISCELLANEOUS POLICIES ............................................................................................................................... 57

NOSB Policy for Presenters Invited by Committees............................................................................... 57

NOSB Policy for Surveys Conducted on Behalf of NOSB Committees ...................................................... 57

NOSB Policy for Public Comment at NOSB Meetings: ............................................................................ 57

SECTION VII .......................................................................................................................................................61

NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING......................................................................... 61

NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE AGRICULTURE AND

CONSISTENCY WITH ORGANIC FARMING AND HANDLING................................................................................. 64

SECTION VIII......................................................................................................................................................65

PROCEDURES OF THE NOSB...............................................................................................................................65

COMMITTEE WORK PLANS ............................................................................................................................... 65

MATERIALS REVIEW PROCESS .......................................................................................................................... 67

Evaluation Procedures for Substances Petitioned for Addition or Removal from the National 

List...................................................................................................................................................... 67

Definitions .......................................................................................................................................... 67

Phase 1: Receipt of Petition and Examination of Petition for Completeness and Eligibility .................. 67

Phase 2: Determine if a Third Party Technical Review is Required....................................................... 68

Phase 3: Evaluation by a Third Party Expert....................................................................................... 68

Phase 4: Sufficiency Determination .................................................................................................... 68

Phase 5: Action by NOSB Materials Chair and the Committee that the Substance Is Being 

Petitioned for Addition or Prohibition from the National List (Crops, Livestock or Handling) .............. 70

Phase 6: Action by Full NOSB .............................................................................................................. 70

PROCEDURES FOR HANDLING TECHNICAL REVIEWS ....................................................................................... 70

HANDLING WITHDRAWALS OF PETITIONS BY THE PETITIONER. .................................................................... 72

TECHNICAL ADVISORY PANEL (TAP) CONTRACT PROCEDURES........................................................................72

STATEMENT OF WORK ........................................................................................................................................... 72

AGENCY NEED....................................................................................................................................................... 72

Phase 1: Data Gathering and Compilation (120 days)......................................................................... 75

Phase 2: Evaluation against Criteria (100 days)................................................................................. 75

Phase 3: Recommendation (42 days).................................................................................................. 75

EVALUATION FACTORS FOR AWARD .......................................................................................................................... 75

OTHER EVALUATION FACTORS ................................................................................................................................. 76

REPORTING REQUIREMENTS .................................................................................................................................... 76

INFORMATION TO BE INCLUDED IN A PETITION............................................................................................... 77

PRIORITY OF PETITIONS GUIDELINE................................................................................................................ 82

NOSB COMMITTEE RECOMMENDATION............................................................................................................ 83

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST .....................................................85

NOSB RECOMMENDED DECISION FORM ............................................................................................................ 90

PROCEDURES FOR THE MATERIALS REVIEW PROCESS FOR NOSB MEMBERS.................................................... 92

SUNSET REVIEW PROCESS ................................................................................................................................ 92

Chart 1: Sunset Review – NOP Posts an ANPR....................................................................................... 94

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 99/302
Chart 2: Sunset Review – NOP Collects and Forwards Public Comment to the NOSB.............................. 94

Chart 3: Sunset Review – NOSB Committee Reviews Evidence for Delisting .......................................... 95

Chart 4: Sunset Review ............................................................................ Error! Bookmark not defined.

Final Rule Process ................................................................................... Error! Bookmark not defined.

HANDLING TECHNICAL ERRORS AFTER AN ITEM HAS BEEN PLACED IN THE FEDERAL REGISTER .................... 95

APPENDICES AND RESOURCES...........................................................................................................................96

APPENDIX A - DECISION MAKING PROCEDURES FOR THENOP............................................................................. 96

APPENDIX B - FACA FACTS ................................................................................................................................... 97

APPENDIX C - DUTIES OF THE DESIGNATED FEDERAL OFFICER ........................................................................... 98

APPENDIX D - PARLIAMENTARY PROCEDURE AT A GLANCE ................................................................................ 99

APPENDIX E - BASIC CHEMISTRY.........................................................................................................................100

I. INTRODUCTION/PURPOSE ....................................................................................................................6

A. NOSB VISION STATEMENT ........................................................................................................................ 6

B. NOSB STATUTORY MISSION...................................................................................................................... 7

C. NOSB MISSION STATEMENT...................................................................................................................... 7

II. AUTHORIZATION...................................................................................................................................7

A. ORGANIC FOODS PRODUCTION ACT OF 1990 .............................................................................................. 7

B. FEDERAL ADVISORY COMMITTEE ACT ........................................................................................................ 8

C. NATIONAL ORGANIC STANDARDS BOARD CHARTER .................................................................................... 8

III. NOSB ADMINISTRATION........................................................................................................................8

A. NOSB MEMBERSHIP .................................................................................................................................... 8

B. NOMINATION AND APPOINTMENT PROCESS.......................................................................................................... 8

C. RESPONSIBILITIES OF THE NOSB....................................................................................................................... 9

D. NOSB OFFICERS ..................................................................................................................................... 11

CHAIR .................................................................................................................................................. 11

VICE CHAIR .......................................................................................................................................... 11

SECRETARY.......................................................................................................................................... 11

ADMINISTRATIVE TEAM ....................................................................................................................... 11

E. NOSB-NOP COLLABORATION .................................................................................................................. 12

F. NOSB WORK AGENDAS .......................................................................................................................... 13

G. DESIGNATED FEDERAL OFFICER ...................................................................................................................... 14

H. ADVISORY COMMITTEE SPECIALIST .................................................................................................................. 16

I. ADDITIONAL ADMINISTRATIVE ITEMS...................................................................................................... 16

J. PROFESSIONAL AND ETHICAL STANDARDS ............................................................................................... 18

1) NOSB Member Professional Conduct Standards............................................................................. 18

2) Additional Standards of Conduct.................................................................................................. 19

3) Failure to participate.................................................................................................................. 20

K. DECLARATION OF INTERESTS/CONFLICT OF INTEREST...................................................................................... 20

IV. SUBCOMMITTEES ................................................................................................................................22

A. STANDING SUBCOMMITTEES.................................................................................................................. 22

B. AD HOC SUBCOMMITTEES ...................................................................................................................... 24

C. SUBCOMMITTEE MEETINGS.................................................................................................................... 24

D. TASK FORCES ........................................................................................................................................ 24

E. DUTIES OF SUBCOMMITTEE CHAIRS AND VICE CHAIRS ............................................................................... 25

F. TRANSITION OF SUBCOMMITTEE CHAIRS, VICE CHAIRS, AND MEMBERS (NEW AND CONTINUING) ................. 25

G. PROCEDURES FOR COMPLETING SUBCOMMITTEE PROPOSALS AND DISCUSSION DOCUMENTS...................... 27

1. Development of proposals ............................................................................................................... 27

2. Types of Proposals.......................................................................................................................... 28

3. Presenting Subcommittee Proposals and Discussion Documents at NOSB Meetings ............................... 28

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 100/302
H. SUBSTANCE/MATERIALS REVIEW PROCESS .............................................................................................. 28

1. Steps in the material review process for a new petition:...................................................................... 28

2. Changes to annotations or classification of materials. ........................................................................ 32

3. Additional considerations concerning Technical Reviews.................................................................... 32

4. Definitions..................................................................................................................................... 33

V. PRIORITIZATION OF PETITIONS ................................................................................................................33

VI. WITHDRAWAL OF A PETITION BY A PETITIONER ........................................................................................34

VII. SUNSET REVIEW PROCESS .......................................................................................................................34

VIII. NOSB PROCEDURES .............................................................................................................................37

A. BOARD MEETINGS ................................................................................................................................. 37

B. CONDUCTING BUSINESS......................................................................................................................... 38

C. PARLIAMENTARY PROCEDURES .............................................................................................................. 43

D. NOSB DELIBERATIONS AND RECOMMENDATIONS..................................................................................... 43

E. PUBLIC COMMENT................................................................................................................................. 54

F. ELECTION OF OFFICERS........................................................................................................................... 59

G. MISCELLANEOUS PROCEDURES ............................................................................................................... 60

1. Invited Speakers............................................................................................................................. 60

2. Surveys Conducted on Behalf of NOSB Subcommittees........................................................................ 60

IX. REVISIONS TO THE POLICY AND PROCEDURES MANUAL.....................................................................60

X. APPENDICES ........................................................................................................................................61

A. APPENDIX 1: FOUNDATIONS ..................................................................................................................... 61

1. NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING.......................................................... 61

2. NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE AGRICULTURE AND 

CONSISTENCY WITH ORGANIC FARMING AND HANDLING........................................................................ 64

3. NOSB MEMBER DUTIES .................................................................................................................. 64

B. APPENDIX 2 – FACA FACTS......................................................................................................................... 96

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 101/302
I. INTRODUCTION/PURPOSE

 

This document is intended as a guideprovides procedures for all membersthe functioning of the 

National Organic Standards Board (NOSB). Board members are entrusted with a strong responsibility 

to treat the business of the Board as fiduciaries for all members of the organic community and the 

public at large. 

 

The Board’s primary role is to advise, rather than administer and implement. As in every business, 

the Board’s success depends heavily upon the ability to understand each other’s respective role, and 

to develop the working relationship necessary within those roles. 

 

This manual ) and is designed to assist the BoardNOSB in its responsibilities. New BoardThis policy 

and procedures manual does not supersede authority or responsibilities as specified in the Federal 

Advisory Committee Act or the Organic Foods Production Act (OFPA). NOSB members are 

encouraged to review this manual in depth as well as to become familiar with the Organic Foods 

Production Act (OFPA), 7 CFR Part 205, and the NOSB NewOFPA, the USDA organic regulations at 7 

CFR Part 205, and the NOSB Member Guide. Existing membersMembers are advised to periodically 

review the contents to refresh their understanding of the Board’sNOSB’s role and their duties. 

NOSB members are entrusted with the responsibility to act in the best interests of all members of 

the organic community and the public at large. The NOSB’s success relies upon the ability to 

understand each other’s respective roles, and to develop successful working relationships. 

The primary roles and duties of the National Organic Standards Board (NOSB): 

Serve 

New policies and revisions to existing policies and procedures will be incorporated into the NOSB 

Policy and Procedures Manual from time to time, as determined by the Board. 

 

 

SECTION I 

 

This section presents the NOSB’s vision and mission statement as well as specifics on NOSB 

members’ duties, and professional and ethical standards. 

 as a link to the organic community 

 Advise USDA on the implementation of OFPA 

 Propose amendments to the National List of Allowed and Prohibited Substances 

 Protect and defend the integrity of organic standards

A. NOSB VISION STATEMENT 

 

(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007). 

The NOSB’s vision is an agricultural community rooted in organic principles and values that 

instills trust among consumers, producers, processors, retailers and other stakeholders. 

Consistent and sustainable organic standards guard and advance the integrity of organic 

products and practices. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 102/302
 

 

B. NOSB STATUTORY MISSION 

 

“(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007). 

To assist in the development of standards for substances to be used in organic 

production and to advise the Secretary on any other aspects of the implementation of this title.” 

. (OFPA, Sec 2119 (a)) 

C. NOSB MISSION STATEMENT 

 

(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007). 

To provide effective and constructive advice, clarification and guidance to the Secretary of 

Agriculture concerning the National Organic Program (NOP), and the consensus of the organic 

community. 

In carrying out the mission, keyKey activities of the Board include: 

 

Assist 

 Assisting in the development and maintenance of organic standards and regulations; 

 REVIEWReviewing petitioned materials for inclusion on or DELETIONremoval from the 

National List of Approved and Prohibited Substances (National List);)

 RECOMMENDRecommending changes to the National List; 

 COMMUNICATECommunicating with the organic community, including conducting public 

meetings, soliciting and TAKING reviewing public comments PROVIDE TIMELY 

INFORMATION AND EDUCATION ON THE NOP, MAKING REASONABLE USE OF A 

VARIETY OF COMMUNICATION CHANNELS.

 COMMUNICATE, SUPPORT AND COORDINATECommunicating, supporting and 

coordinating with the NOP staff;

DUTIES OF THE BOARD AND OFFICERS 

II. AUTHORIZATION 

The National Organic Standards Board (NOSB) is authorized under Section 2119 of the

The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6519), part of the Food, Agriculture, 

Conservation, and Trade Act of 1990 (FACT Act). The OFPA specified that the NOSB be established 

in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 

U.S.C. App. 2. 

A. ORGANIC FOODS PRODUCTION ACT OF 1990

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 103/302
The Organic Foods Production Act of 1990 (OFPA) authorizes the Secretary of Agriculture to 

establish a National Organic Standards Board (NOSB) in accordance with the Federal Advisory 

Committee Act to assist in the development of standards for substances to be used in organic 

production and to advise the Secretary on any other aspects of the implementation of OFPA 

(OFPA, 7 U.S.C. Section 6518(a)). 

B. FEDERAL ADVISORY COMMITTEE ACT 

The Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and its implementing regulations 

(41 CFR Part 101-6.10) govern the creation, operation, and termination of advisory committees 

in the Executive Branch of the Federal Government. The National Organic Standards Board 

(NOSB) is a Department of Agriculture (USDA) non-discretionary advisory committee required by 

the Organic Foods Production Act of 1990, as amended. 

C. NATIONAL ORGANIC STANDARDS BOARD CHARTER 

The Federal Advisory Committee Act requires advisory committees to have an official charter 

prior to meeting or taking any action. An advisory committee charter is intended to provide a 

description of an advisory committee’s mission, goals, and objectives. The NOSB charter is 

renewed every two years as a requirement of FACA. The NOSB charter describes the purpose of 

the NOSB to “assist in the development of standards for substances to be used in organic 

production and to advise the Secretary on any other aspects of the implementation of OFPA.” 

III. NOSB ADMINISTRATION 

A. NOSB definesMembership 

OFPA specifies the membership composition of the NOSB as follows. The NOSB shall be 

composed of 15 members, of which: 

 Four shall be individuals who own or operate an organic farming operation; 

 Two shall be individuals who own or operate an organic handling operation; 

 One shall be an individual who owns or operates a retail establishment with significant trade 

in organic products; 

 Three shall be individuals with expertise in areas of environmental protection and resource 

conservation; 

 Three shall be individuals who represent public interest or consumer interest groups; 

 One shall be an individual with expertise in the fields of toxicology, ecology, or biochemistry; 

and 

 One shall be an individual who is a certifying agent as identified under OFPA, 7 U.S.C. 

§ 6518(b) 

B. Nomination and appointment process 

(NOSB recommendation adopted June 10, 1999) 

NOSB members are appointed by the Secretary of Agriculture to a five year term. The terms are 

staggered and the USDA periodically requests nominations to fill upcoming vacancies. Selection 

criteria include the following specific responsibilities for the Board starting at Sec 2119: 

 A general understanding of organic principles, and practical experience in the organic 

community, particularly in the sector for which the person is applying 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 104/302
 Demonstrated experience in the development of public policy such as participation on 

public or private advisory boards, boards of directors or other comparable organizations 

 Participation in standards development and/or involvement in educational outreach 

activities 

 A commitment to the integrity and growth of the organic food and fiber industry 

 The ability to evaluate technical information and to fully participate in Board deliberation 

and recommendations 

 The willingness to commit the time and energy necessary to assume Board duties 

 Not currently serving (or have been elected to serve) on another USDA advisory committee 

or research and promotions council/board during your term 

 Not registered as a lobbyist with the federal or state government 

NOSB members serve without compensation. NOSB members are reimbursed by the USDA for 

approved travel and associated lodging expenses as determined by official federal government 

guidelines and regulations. In accordance with USDA policies, equal opportunity practices are 

followed in all appointments to the NOSB. Membership shall include to the extent possible the 

diverse groups served by USDA, including minorities, women, and persons with disabilities. 

The USDA prohibits discrimination in all of its programs and activities on the basis of race, color, 

national origin, age, disability, and where applicable, sex, marital status, familial status, parental 

status, religion, sexual orientation, political beliefs, genetic information, reprisal, or because all 

or part of an individual's income is derived from any public assistance program. 

C. Responsibilities of the NOSB 

(OFPA, 7 USC 6518(k) )):

 

(1) IN GENERAL.—In General. The Board shall provide recommendations to the Secretary regarding 

the implementation of this titlechapter. 

(2) NATIONAL LIST.—National List. The Board shall develop the proposed National List or proposed 

amendments to the National List for submission to the Secretary in accordance with section 21186517 of 

this title. 

(3) TECHNICAL ADVISORY PANELS.—Technical Advisory Panels. The Board shall convene 

technical advisory panels to provide scientific evaluation of the materials considered for inclusion in the 

National List. Such panels may include experts in agronomy, entomology, health sciences and other 

relevant disciplines. 

(4) SPECIAL REVIEW OF BOTANICAL PESTICIDES.—(4) Special Review of Botanical 

Pesticides. The Board shall, prior to the establishment of the National List, review all botanical pesticides 

used in agricultural production and consider whether any such botanical pesticidepesticides should be 

included in the list of prohibited natural substances. 

(5) PRODUCT RESIDUE TESTING.—Product Residue Testing. The Board shall advise the Secretary 

concerning the testing of organically produced agricultural products for residues caused by unavoidable 

residual environmental contamination. 

(6) EMERGENCY SPRAY PROGRAMS.—Emergency Spray Programs. The Board shall advise the 

Secretary concerning rules for exemptions from specific requirements of this TITLEchapter

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 105/302
(except the provisions of section 21126511 of this title) with respect to agricultural products 

produced on certified organic farms if such farms are subject to a Federal or State emergency 

pest or disease treatment program. 

(Additional Duties included in Requirements. (OFPA but not limited to): 

6518(n) PETITIONS. Thel)) In establishing the proposed National List or proposed 

amendments to the National List, the Board shall establish procedures under which persons may 

petition the Board for the purpose

(1) review available information from the Environmental Protection Agency, the National 

Institute of Environmental Health Studies, and other sources as appropriate, 

concerning the potential for adverse human and environmental effects of substances 

considered for inclusion in the proposed National List; 

(2) work with manufacturers of substances considered for inclusion in the proposed 

National List to obtain a complete list of ingredients and determine whether such 

substances contain inert materials that are synthetically produced; and 

(3) submit to the Secretary, along with the proposed National List or any proposed 

amendments to such list, the results of the Board's evaluation and the evaluation of 

the technical advisory panel of all substances considered for inclusion in the National 

List. 

Evaluation. (7 USC 6518(m)) In evaluating substances considered for inclusion on the National 

List. the NOSB shall consider:

1. 6509(d) (2) STANDARDS. the potential of such substances for detrimental chemical 

interactions with other materials used in organic farming systems; 

2. 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; 

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

disposal of such substance; 

4. the effect of the substance on human health; 

5. the effects of the substance 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; 

6. the alternatives to using the substance in terms of practices or other available 

materials; and 

7. compatibility with a system of sustainable agriculture. 

Petitions. (7 USC 6518(n)) 

The board shall establish procedures for receiving petitions to evaluate substances for inclusion 

on the List 

Sunset Provision. (7 USC 6517 (e)) No exemptions or prohibition contained in the National List 

shall be valid unless the National Organic Standards Board SHALL RECOMMEND TO has 

reviewed such exemption or prohibition as provided in this section within 5 years of such 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 106/302
exemption or prohibition being adopted or reviewed and the Secretary has renewed such 

exemption or prohibition. 

D. NOSB OFFICERS 

Three principal officers, Chair, Vice Chair and Secretary, guide the NOSB. The NOSB 

members hold an election each fall at the public meeting to elect these three members. 

CHAIR 

The Chair is responsible for ensuring the integrity of the NOSB process, effectiveness of 

meetings and adherence to NOSB policies and procedures. The primary duties of the 

Chair are as follows: 

 Schedules meetings of the Executive Subcommittee, in collaboration with the NOP 

 Serves as a member of, convenes, and facilitates Executive Subcommittee meetings 

 Convenes and presides over NOSB meetings 

 Participates in the administrative team meetings 

 Drafts NOSB meeting agendas in consultation with Subcommittee chairs and the 

NOP 

 Reviews Subcommittee work agendas 

 Reviews NOSB meeting minutes for accuracy 

 Assists with the annual election of NOSB officers and announces the new officers 

VICE CHAIR 

The Vice Chair acts in the absence of the Chair. The primary duties of the Vice Chair are 

as follows: 

 Serves as a member of the Executive Subcommittee 

 Participates in the administrative team meetings 

 Serves as a member of the Policy Development Subcommittee

 Helps maintain the Policy and Procedures Manual and ensures its accuracy 

SECRETARY 

The primary duties of the Secretary are as follows: 

 Serves as a member of the Executive Subcommittee 

 Participates in the administrative team meetings 

 Records all NOSB member votes at NOSB meetings, and in collaboration with the 

Advisory Committee Specialist (ACS), circulates that record to NOSB members for 

approval 

 Assists with the annual election of NOSB officers 

 May delegate tasks to others, but retains responsibility for the official record 

ADMINISTRATIVE TEAM 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 107/302
The Administrative Team consists of the Chair, Vice Chair, Secretary, and Designated 

Federal Official/Advisory Committee Specialist. . This group is responsible for 

coordinating logistics and operations of the Board. The Administrative team meets via 

teleconference once or twice a month on an as-needed basis, to be determined by the 

Administrative Team.

E. NOSB-NOP COLLABORATION 

In 1990, the Organic Foods Production Act (OFPA: 7 U.S.C. 6518 (a)) directed the Secretary of 

Agriculture to “establish a National Organic Standards Board (in accordance with the Federal 

Advisory Committee Act (FACA)) ... to assist in the development of standards for substances to 

be used in organic production and to advise the Secretary on any other aspects of the 

implementation” of the Act. Section 6503 (a) of the OFPA requires that the Secretary “shall 

establish an organic certification program ... and shall consult with the NOSB” (6503(c)). The 

National Organic Program (NOP) is the governmental institution responsible for implementing 

the OFPA and is the means through which the NOSB provides advice and assistance to the 

Secretary of Agriculture. The NOSB, as a FACA advisory committee, must conduct business in 

the open, under the requirements of P.L. 94-409, also known as “Government in the Sunshine 

Act” (5 U.S.C.552b). 

The USDA cannot delegate its authority as a regulatory body to private citizens, even when 

those private citizens are appointed by the Secretary to provide advice. Therefore, the NOSB 

cannot direct USDA or bind the Secretary through its actions; for example, it cannot obligate 

funds, contract, make NOP staffing decisions, or initiate policies of its own accord 

However, the NOSB has unique statutory authority related to the recommendation of materials 

as approved or prohibited substances for inclusion on the National List. 

The unique nature of the NOSB and its relationship with the NOP, as established through OFPA, 

requires that the volunteer Board, which regularly receives stakeholder input through public 

comment, must work collaboratively with the NOP. 

Similarly the NOP, as required through OFPA, must consult and collaborate with the NOSB 

Team work and collaboration between the NOSB and the NOP, as well as others in the organic 

community, is needed to maintain, enhance and promote the integrity of organic principles and 

products. Successful collaboration is dependent on effective communication and constructive 

feedback. Communication is facilitated by the Advisory Committee Specialist, who participates 

in all NOSB calls. Additionally, the NOP Deputy Administrator or designee will participate in all 

ES calls, and in other standing Subcommittee calls upon request and mutual agreement. In 

addition, each standing Subcommittee will be assigned an NOP staff person to provide 

technical, legal, and logistical support. 

The work of the NOP and NOSB since the 1990 passage of the OFPA clearly demonstrates the 

need for the high level of collaboration and consultation described above. NOP, NOSB and its 

associated stakeholders must continuously work to seek common ground, collaborate and 

consult in order to build organics and maintain organic integrity. Every aspect of this work 

must take place in a manner which clearly demonstrates mutual respect and positive intent. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 108/302
F. NOSB WORK AGENDAS 

The NOSB Work agenda is a list of projects for the upcoming semester or year for each of the 

Subcommittees. Agendas are developed via collaboration between the NOSB and the NOP and 

are revised based on AMS-NOP requests, NOSB priorities, and public comment. 

Work agendas are developed based on the following criteria: 

 Within Scope: Item must be within the scope of OFPA. NOP must have a clear sense of the 

intent and scope of the work agenda item. The public may petition additions or deletions 

from the National List that will be added to the work agenda. In addition, the public may 

submit comments to the NOSB or write to the NOP for potential additions to the work 

agenda. For the NOSB, work agenda items may emerge from discussions on current issues. 

 USDA and NOP Priority: Item must be a priority for the USDA/NOP; something that the NOP 

is able to implement in a reasonable timeframe. 

 Clear Need: Item must reflect a clear need for the NOP and/or organic community, for 

which new or additional information or advice is needed. 

The NOSB work agenda establishes Subcommittee work for the upcoming semester or year, and 

is developed through the following process: 

1. NOSB Subcommittees submit to the Executive Subcommittee draft work agenda items 

based on AMS-NOP requests, NOSB priorities, and requests from public comment. 

2. The NOP and Executive Subcommittee review the draft NOSB work agenda. The content and 

schedule will be reviewed on an ongoing, as needed basis. 

3. NOP confirms the final NOSB work agenda, and provides written confirmation. . 

Work agenda items should be prioritized accordingly: 

1. Substance evaluations (e.g., 5-year sunset review, petitions) 

2. NOP requests to the NOSB 

3. NOSB requests to NOP 

4. Other projects 

Below are descriptions of common NOSB work agenda items and the corresponding NOP and NOSB 

responsibilities. 

 Review of materials proposed to be added to or removed from the National List

The NOSB has the statutory authority to consider and recommend materials for addition to, 

or deletion from, the National List of Approved and Prohibited Substances. The NOSB may 

also make recommendations to add, remove, or modify annotations restricting the use of 

such listed materials. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 109/302
 Changes to annotation or classification of materials

The NOSB may request to review an existing substance on the National List without a new 

petition when they have justification to support a revision of the annotation or 

reclassification of the substance. This may happen as a result of the sunset review process, 

or as new information is provided in a Technical Review, or from public comment. 

 Recommendation for modification of existing standards or new standards 

The NOP may request that the NOSB develop recommendations for new or existing 

standards. The request should be in writing and include a statement of the problem to be 

addressed, background, including the current policy or situation, statutory/regulatory 

authority, legal context, and desired timeframe for receiving the recommendation. The 

request will be posted on the NOP web site.

 Advice on NOP policy and interpretation of standards

The NOSB may provide comments on guidance or policy memos included in the Program 

Handbook, or may also make recommendations for new guidance or policies. 

 Compliance and Enforcement 

The NOP is responsible for compliance and enforcement. The NOP welcomes NOSB input on 

standards, but NOSB involvement in active investigations or enforcement actions is not 

appropriate. When timely and appropriate, the NOP reports to the NOSB the status of 

enforcement actions and also posts the status on the NOP web site. 

 Management ReviewIN ADDITION TO THOSE IN PARAGRAPH (1) FOR THE CARE OF 

LIVESTOCK

The NOSB may review the quality management system and internal audits to ensure that 

SUCH LIVESTOCK IS ORGANICALLY PRODUCED. the NOP is managed effectively and 

efficiently. For example, the NOSB may be asked for informal feedback or to work on 

specific work agenda items that relate to the development or implementation of audit 

corrective actions. 

 

To fulfill their responsibilities, Board members agree to adhere to three duties as described in this 

Manual: 

 Duty of Care 

 Duty of Loyalty 

 Duty of Obedience 

Duty of Care 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 110/302
The Duty of Care calls upon a member to participate in the decisions of the Board and to be 

informed as to the data relevant to such decisions. In essence, the Duty of Care requires that a 

member: 

 Be reasonably informed—It is the duty of all Board members to seek and study the information 

needed to make a reasoned decision and/or recommendation on all business brought before the 

Board. The NOP will provide some of that information, but other information must be developed 

from independent sources. 

 Participate in decisions—Board members are bound by responsibility to be 

active participants in decision-making. Absence from a meeting is no protection 

from the responsibility for decisions made at the meeting. 

 Make decisions with the care of an ordinary prudent person in a similar position—The law does not 

expect Board members to act as super human. It simply requires Board members to exercise 

judgment of an ordinary prudent person who may be faced with a similar issue. 

Duty of Loyalty 

The Duty of Loyalty requires Board members to exercise their power in the interest 

of the public and not in their own interest or the interest of another entity or person. 

A Board member’s loyalty is to the organic community and the public at large. In 

dispatching their Duty of Loyalty, Board members must: 

 Address conflicts of interest—Board members bring to the NOSB particular 

areas of expertise based upon their personal and business interests in organic 

production and marketing. Board members may have interests in conflict with 

those of the public interests. Board members must be conscious of the potential 

for such conflicts and act with candor and care in dealing with such situations. 

Board members must abide by the NOSB conflict of interest policy. 

 Recognize corporate opportunity—Before a Board member votes upon an issue in which they have a 

direct financial interest, that Board member must disclose the transaction to the Board in sufficient 

detail and adequate time to enable the Board to act—or decline to act—in regard to such 

transaction. 

Duty of Obedience 

Board members are bound to obey the tenants of the laws and regulations governing organic 

production, processing and marketing. To this effect, Board members must: 

G. Act within the requirements of the law—Board members must uphold all state 

and federal statutes, including theDesignated Federal Advisory Committee Act (Officer 

 FACA – and its implementing regulations (5 U.S.C. App. 2 et seq.).) govern the roles and 

responsibilities of NOSB management including meeting coordination and facilitation. The 

Designated Federal Officer (DFO) is the individual designated to implement advisory committee 

procedures. The AMS/NOP Deputy Administrator is the DFO for the NOSB.

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 111/302
 Follow the responsibilities of the Board as defined by the Organic Foods Production Act of 1990. 

Follow the The NOP Deputy Administrator or designee acts as the Designated Federal Officer 

(DFO) during public meetings of the NOSB and meetings of the Executive Subcommittee. The 

Advisory Committee Specialist (ACS) or designee acts as the DFO for all other NOSB 

Subcommittee meetings. The DFO holds the authority to chair meetings when directed to do so 

by the official to whom the advisory committee reports. 

The DFO’s duties include but are not limited to: 

 Approving and calling the meeting of the NOSB 

 Approving the semi-annual meeting agenda 

 Attending the semi-annual meetings 

 Adjourning the meetings when such adjournment is in the public interest 

H. Advisory Committee Specialist 

The Advisory Committee Specialist (ACS) is an NOP staff member who is assigned to support the 

NOSB. The Advisory Committee Specialist prepares the Advisory Committee’s and 

Subcommittees’ meeting agendas and notes, and attends all meetings. The position of Advisory 

Committee Specialist (formerly called Executive Director) was added in 2005 to facilitate 

communication and collaboration between the NOP and the NOSB. Advisory Committee 

Specialist duties include but are not limited to: 

 Ensuring that all FACA and OFPA requirements SPECIFIED IN THE NOSB POLICY AND 

PROCEDURES MANUAL.are implemented

 

 

 Maintaining Professional and Ethical Standards 

 Managing calendars and work agendas to facilitate Subcommittee and NOSB activities 

 Arranging, facilitating, and documenting the NOSB Subcommittee conference calls 

 Ensuring NOSB members have all necessary materials and information to provide informed, 

structured and timely recommendations to the NOP 

 Conducting meeting planning activities for the semi-annual NOSB meetings, including 

preparation of Federal Register notices and press releases, and facilitation of public 

comments 

 Coordinating the NOSB nomination and chartering process 

 Facilitating training of NOSB members 

 Managing information reporting and communication between the NOSB and NOP 

I. ADDITIONAL ADMINISTRATIVE ITEMS 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 112/302
 Official to whom the Committee Reports 

The NOSB shall provide recommendations to the USDA Secretary through the Designated 

Federal Officer, the Agricultural Marketing Service’s NOP Deputy Administrator.

 Staff Support 

The NOP shall provide administrative support to the NOSB through the work of an Advisory 

Committee Specialist, who is a permanent NOP staff member. The NOP may also provide 

technical support to the NOSB based on need and available resources. 

 Estimated Number and Frequency of Meetings 

The NOSB meets approximately twice per year for public meetings. Most NOSB 

Subcommittees meet approximately twice a month by conference call. 

 Recordkeeping 

Records of the NOSB shall be handled in accordance with General Records Schedule 26, Item 

2 or other approved agency records disposition schedule. These records shall be available 

for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552. 

Information about the NOSB is available online at: 

http://www.ams.usda.gov/rules-regulations/organic/nosb

While meeting transcripts are not required under FACA, the NOP provides transcripts or 

meeting notes to support the transparency of NOSB meetings and to support subsequent 

rulemaking activities. Minutes of each NOSB meeting, as approved by the DFO and the 

NOSB Chair and Secretary, shall contain a record of the persons present, a complete and 

accurate description of matters discussed and conclusions , and the outcome of voting. 

FACA requires (5 U.S.C. App. Section 10 (b) ): “Subject to section 552 of title 5, United States 

Code, the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, 

agenda, or other documents which were made available to or prepared for or by each 

advisory committee shall be available for public inspection and copying at a single location 

in the offices of the advisory committee or the agency to which the advisory committee 

reports until the advisory committee ceases to exist.”

Any request for FACA records must be made to the NOP.

While requests for FACA Board records do not have to go through the formal FOIA request 

process, those records must be reviewed by AMS/NOP before release, to determine 

whether any FOIA exemptions apply (e.g., personal information, business proprietary 

information). In addition, OFPA itself requires that no confidential business information be 

released, so emails and documents need to be reviewed before release to ensure that this 

requirement is met. 

 Freedom of Information Act (FOIA; 5 U.S.C. 552). Under this Act, the public may request 

documents and other information pertaining to USDA actions. NOSB communications with 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 113/302
USDA (including email) are subject to these requests, with limited exemptions. Some USDA 

information is routinely exempt from disclosure in or otherwise protected from disclosure 

by statute, Executive Order or regulation; is designated as confidential by the agency or 

program; or has not actually been disseminated to the general public and is not authorized 

to be made available to the public upon request. When there is a FOIA request for 

information, the USDA will review all relevant information and determine what qualifies for 

release, then provide it to the requestor. 

J. PROFESSIONAL AND ETHICAL STANDARDS 

As appointees of the Secretary, NOSB members must maintain high professional and 

ethical standards for the conduct of all activitiesboth within and outside of the 

NOSB. Areas of particular concern include professional conduct and conflict of interest. 

1) NOSB Member Professional Conduct Standards

Public service is a public trust, requiringNOSB members shall: 

o Observe ethical principles above private gain in the service of public trust.

 

o NOSB members shall putPut forth an honest effort in the performance of their 

NOSB duties.

o NOSB members shall makeMake no commitments or promises of any kind 

purporting to bind the Government. 

Act

o NOSB members shall act impartially and not give preferential treatment to any 

organization or individual.

 Participate in meetings – Subcommittee conference calls as well as semi-annual 

meetings 

 Serve on Subcommittees as assigned - Each member must be willing to serve on 

Subcommittees as assigned by the NOSB Chair, and to participate in the work of 

those Subcommittees. 

 Be informed about NOSB business - NOSB members are expected to seek and study 

the information needed to make reasoned decisions and/or recommendations on all 

business brought before the NOSB. 

To maintain the highest levels of honesty, integrity, and ethical conduct, no NOSB 

member shall participate in any “specific party matters” (i.e., matters that are narrowly 

focused and typically involve specific transactions between identified parties) such as a 

lease, license, permit, contract, claim, grant, agreement, or related litigation with the 

Department in which the member has a direct or indirect financial interest. This includes 

the requirement for NOSB members to immediately disclose to the NOP’s Advisory 

Board Specialist any specific party matter in which the member’s immediate family, 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 114/302
relatives, business partners, or employer would be directly seeking to financially benefit 

from the Board’s recommendations. 

o All NOSB members, committee members and task force members shall not engage in a financial 

transaction using nonpublic information, not allow the improper use of nonpublic information 

to further his/her own private interest or that of another, whether through advice or 

recommendation, or allow the unauthorized disclosure of nonpublic information. 

Nonpublic information ismembers receive ethics training annually to identify and 

avoid any actions that would cause the public to question the integrity of the NOSB’s 

advice and recommendations. The provisions of these paragraphs are not meant to 

exhaustively cover all Federal ethics laws and do not affect any other statutory or 

regulatory obligations to which advisory committee members are subject. 

2) Additional Standards of Conduct 

NOSB members should adhere to the following basic “standards of conduct” while in 

government service: 

 Do not accept improper gifts (from those seeking actions from the Board). 

 Do not use board appointments for private gain. 

 Do not misuse internal non-public government information. 

 Do not use government property and time improperly. 

 Do not accept compensation for teaching, speaking, and writing related to your 

board duties. 

 Do not engage in partisan political activities while performing your board duties or 

while in a federal building. 

 Alert the NOSB designated federal officer (DFO) if you or your employer enters into 

a lawsuit against USDA or its sub-agencies.

o Refrain from sharing working documents with the public. Working documents are 

defined as information that THEa board member gains by reason of participation in 

the NOSB and that he/she knows, or reasonably should know, has not been made 

available to the general public. THIS INCLUDES INFORMATION THAT IS 

“ROUTINELY EXEMPT FROM DISCLOSURE IN 5 U.S.C. 552 (FREEDOM OF 

INFORMATION ACT) OR OTHERWISE PROTECTED FROM DISCLOSURE BY 

STATUTE, EXECUTIVE ORDER OR REGULATION; IS DESIGNATED AS 

CONFIDENTIAL BY THE AGENCY OR PROGRAM; OR HAS NOT ACTUALLY 

BEEN DISSEMINATED TO THE GENERAL PUBLIC AND IS NOT AUTHORIZED 

TO BE MADE AVAILABLE TO THE PUBLIC UPON REQUEST.” : e.g. is not on 

the NOP or other public websites, or is a draft document under development by an 

NOSB Subcommittee.

 Do not circulate draft Subcommittee documents until they are finalized and publicly 

available to all on the AMS/NOP website. 

 Use a professional, respectful tone in NOSB email correspondence; remember that 

all correspondence with government officials is subject to FOIA requests. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 115/302
o NOSB members, committee members and task force members shall keep confidential all 

information identified by petitioners as confidential business information.

1

 

o To the maximum extent possible, NOSB members should speak with one voice. 

Although there may be disagreements within NOSB COMMITTEESubcommittees or 

working group sessions, once NOSB members leave the session, they have the 

responsibility to support the integrity of the process, whether or not they agree with 

the final outcome. While NOSB members retain the right to express minority 

opinions, the public airing of dissension could strain interpersonal relationships and 

create distrust and conflict among NOSB members. Such stresses could undermine 

the NOSB’s ability to effectively carry out its role as a governmental advisory board. 

3) Failure to participate 

The NOSB typically has a heavy work load and thus active participation by all 15 

members is essential to carry out the mandates in OFPA. When one or more 

members fail to actively participate in Board work the entire NOSB and the organic 

community is negatively impacted. If a Board member finds that s/he cannot 

consistently attend Subcommittee meetings, take on work assignments, complete 

Subcommittee work in a timely manner, or cannot attend the twice-yearly public 

meetings and public comment listening sessions, the NOSB Chair shall discuss the 

matter with the Board member, bring the concerns to the attention of the Executive 

Subcommittee, and if necessary encourage the Board member to resign. 

K. DECLARATION OF INTERESTS/Conflict of Interest 

NOSB members are classified as representatives under the Federal Advisory Committee Act 

(FACA). Each representative is appointed to articulate the viewpoints and interests of a 

particular interest group. The Organic Foods Production Act (OFPA) prescribes these interest 

groups, which include farmers/growers, handlers, certifiers, environmentalists/conservationists, 

scientists, consumers and public interest groups, and retailers. Representatives are appointed to 

speak in “we” terms, serving as the voice of the group represented (e.g., “we farmers/growers 

believe...”). As such, NOSB members are not expected to provide independent expert advice, 

but rather advice based on the interests of the groups served. 

 

NOSB members represent the interests of a particular group. As such, many of the interests are 

acceptable interests. An interest is acceptable if it is carried out on behalf of a represented 

group, and if a Board member receives no disproportionate benefit from expressing the interest. 

True conflicts of interest arise when an interest: 

 Directly and disproportionally benefits you or a person associated with that member; 

 Could impair your objectivity in representing your group; or 

 Has the potential to create an unfair competitive advantage. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 116/302
The appearance of a personal conflict and loss of impartiality, while not a true conflict, must be 

considered when conducting NOSB business. 

Declarations of Interest/Conflicts of Interest Procedures 

Board members are appointed in part because of their interests. As such, each NOSB member 

needs to actively consider their interests with respect to topics being considered by the Board, 

and identify whether these interests would create appearance problems. This consideration 

should occur at two specific points during the Board’s work on a particular topic. The first 

consideration should occur at the Subcommittee level, when a Subcommittee begins work on 

material or topic. The second is when a discussion document or proposal advances from the 

Subcommittee to the full Board for consideration. 

At the Subcommittee Level 

NOSB members represent the diverse interests of a broad stakeholder community, and make 

recommendations that may have wide-reaching regulatory impacts across all of these interest 

groups. As such, NOSB member actions are carefully scrutinized. 

Given this, the NOP has provided the following guidelines for NOSB members working at the 

Subcommittee level: 

 Avoid leading projects for which you could reasonably be viewed by others as having a particular 

interest that would hinder your ability to objectively and fairly represent broader group 

interests, and to allow other members to represent theirs. If leading a project would likely lead 

others to believe you are “self-dealing” to benefit yourself or someone close to you, you should 

refrain from leading. 

 If you feel you may have an appearance problem or conflict of interest, you should inform the 

DFO that a conflict may exist, and describe the nature of that conflict. You should also tell the 

subcommittee impacted that you may have a conflict; sharing as much or as little about the 

nature of the conflict with other board members as you wish. After this declaration, you may 

continue to contribute to the discussion on the topic. As long as it is known there is a conflict of 

interest, the conflict does not preclude the member from contributing his or her input to the 

subcommittee. 

 If you are uncertain as to whether an interest constitutes an appearance problem or a true 

conflict, then contact the DFOto discuss it. In this case, the NOP, working with the USDA office of 

ethics as needed, will make the determination about whether a problem exists. 

At the Full Board Level 

Once discussion documents and proposals are posted for public comment, each NOSB member is to 

review the documents across all Subcommittees, and research any potential conflicts of interest due 

to organizational affiliation or relationships. 

The following procedures will take place at the Board level: 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 117/302
1. Approximately 2-4 weeks before the meeting, the NOP’s DFO will provide a matrix to all 

NOSB members that lists the items being considered at the meeting. 

2. If you determine that you do have a conflict of interest, use the matrix to disclose that 

information and to declare a recusal from voting on the item(s). 

3. If you are not sure whether an interest is acceptable or poses a problem, or if you are 

uncertain whether recusal is needed, contact the NOP DFO to discuss. The NOP – working 

with the USDA office of ethics as needed - will make the determination about whether a 

conflict of interest exists, and will instruct the member accordingly as to whether to vote or 

not. 

4. Return your completed matrix approximately one week before the board meeting. The NOP 

will then use these to compile a list of all recusals for the meeting. 

5. At the meeting, at the beginning of each subcommittee session or at a time designated at 

the discretion of the board chair, the DFO will state: “the following board members have a 

conflict of interest with the following documents, and will not be voting: e.g. Bob has a 

conflict and will recuse himself from the proposals CleanGreenA and GreatChemB 

(etcetera).” 

6. Once the DFO completes listing the recusals, the NOSB Subcommittee chair leading the 

session may invite additional information from members on a voluntary basis, with a 

statement such as: “if Board members wish to disclose information about their conflict, or 

any other information about their interests, they are welcome to do so at this time.” this is 

to be stated as a general and voluntary invitation; no specific NOSB member is to be called 

on. 

7. For any documents deferred to the last day of the meeting, the DFO will repeat the 

declaration of statement above at the start of the voting session for each subcommittee. 

When it is time to vote, the NOSB member recusing her/his self should state “recuse” when 

it is his or her time to vote. 

IV. SUBCOMMITTEES 

Subcommittees play an important role in administering the NOSB’s responsibilities to make 

informed decisions. The Subcommittees are responsible for conducting research and analyses, 

and drafting proposals for consideration by the full NOSB. No Subcommittees are authorized to 

act in place of the NOSB. Subcommittees are either standing or ad hoc 

A. STANDING SUBCOMMITTEES 

The current standing Subcommittees are: 

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 Executive (ES) 

 Certification, Accreditation, and Compliance (CACS) 

 Crops (CS) 

 Handling (HS) 

 Livestock (including Aquaculture) (LS) 

 Materials (including GMOs) (MS) 

 Policy Development (PDS) 

Executive Subcommittee (ES) 

The Executive Subcommittee of the NOSB shall be comprised of the Chair, Vice Chair, 

Secretary, and the Chairs of each of the standing Subcommittees. The Executive 

Subcommittee provides overall coordination for the NOSB including finalizing the NOSB 

meeting agenda and NOSB work agendas. 

Certification, Accreditation, and Compliance Subcommittee (CACS) 

The CACS drafts proposals for consideration by the NOSB to provide guidance, clarification, 

or proposed standards for the certification, accreditation and compliance sections of the 

USDA organic regulations and OFPA. 

 

Crops Subcommittee (CS)

The CS drafts proposals for consideration by the NOSB to provide guidance, clarification, or 

proposed standards for the crop production sections of the USDA organic regulations and 

OFPA. The CS reviews substances under sunset review and petitions for addition to, or 

removal from the National List of Allowed and Prohibited Substances. The CS reviews 

technical reports (TRs), technical advisory panel reports (TAPs), and public comments 

concerning materials used for organic crop production to draft their proposals. 

 

Handling Subcommittee (HS) 

The Handling Subcommittee drafts proposals for consideration by the NOSB to provide 

guidance, clarification, or proposed standards for the handling and labeling sections of the 

USDA organic regulations and OFPA. The HS reviews substances under sunset review and 

petitions for addition to or removal from the National List of Allowed and Prohibited 

Substances. The HS reviews technical reports (TRs), technical advisory panel reports (TAPs), 

and public comments concerning materials used for organic handling to draft their 

proposals. 

Livestock Subcommittee (including Aquaculture) (LS) 

The LS drafts proposals for consideration by the NOSB to provide guidance, clarification, or 

proposed standards for the livestock and livestock feed sections of the USDA organic 

regulations and OFPA. The LS reviews substances under sunset review and petitions for 

addition to or removal from the National List of Allowed and Prohibited Substances. The LS 

reviews technical reports (TRs), technical advisory panel reports (TAPs), and public 

comments concerning materials used for organic livestock and aquaculture production to 

draft their proposals. 

 

Materials Subcommittee (including Genetically Modified Organisms) (MS)

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The MS drafts proposals for consideration by the NOSB to provide guidance, clarification, 

or proposed standards for the pertinent National List sections of the USDA organic 

regulations and OFPA. The MS works with the NOP and other NOSB Subcommittees in 

managing the Materials Review Process, which may include determining which 

Subcommittee will conduct a review, as well as tracking technical reports and the status of 

reviews for petitions and sunset materials. The MS also drafts proposals and discussion 

documents regarding the prohibition on the use of Genetically Modified Organisms 

(excluded methods) under the USDA organic regulations. Research Priorities are also a 

critical component of the annual work agenda of the MS. 

In addition to a Chair, who will be appointed by the NOSB Chair, the MS shall include in its 

membership a representative from each of the Livestock, Crops, and Handling 

Subcommittees. 

Policy Development Subcommittee (PDS) 

The Policy Development Subcommittee provides clarification and proposed changes for 

NOSB internal policies, and procedures as needed, in collaboration with the NOP. The PDS, 

in collaboration with the NOP, also updates and revises the NOSB Policy and Procedures 

Manual and the Member Guide. 

B. AD HOC SUBCOMMITTEES 

At the discretion of the NOSB Chair, and with approval of the Executive Subcommittee and 

the DFO, ad hoc NOSB Subcommittees may be formed to develop policy and guidance on 

specific issues that involve multiple standing Subcommittee jurisdictions, or for issues or 

tasks that are very large and require additional resources to complete. Ad hoc 

Subcommittees must be comprised of current NOSB members, and may be either a 

combination of two or more standing Subcommittees to form a “joint” Subcommittee, or 

may be a completely new Subcommittee comprised of selected NOSB members from 

various standing Subcommittees. Ad hoc Subcommittees can be dissolved at the 

recommendation of the NOSB chairperson with the approval of the Executive 

Subcommittee. Ad hoc Subcommittee Chairpersons are non-voting members of the 

Executive Committee. 

C. SUBCOMMITTEE MEETINGS 

Subcommittees generally hold meetings once or twice a month via telephone 

conference calls. Calls are scheduled well in advance on a regular reoccurring interval. 

Additional meetings can be held if a Subcommittee requests additional time and the 

NOP agrees to provide the resources to support the additional meeting. A majority of 

the members of a Subcommittee shall constitute a quorum for the purpose of 

conducting Subcommittee business. 

D. TASK FORCES 

The NOSB may request the establishment of a Task Force to explore specific issues or 

concerns relevant to the organic community and industry, and present to the NOSB 

draft proposals, discussion documents, or reports. Each task force shall: 

 Have a specific work agenda approved by the NOP 

 Have a clearly articulated project deliverable 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 120/302
 Include at least one current member of the NOSB 

 Record and maintain meeting or conference call minutes, made available to the 

NOSB and the NOP 

 Submit a final report to the NOSB 

 Disband when the NOP notifies the Task Force that its work has concluded or when 

the task force is no longer necessary. 

 Have a specific start and end date, which may be extended by the Executive 

Subcommittee, with concurrence by NOP. 

E. DUTIES OF SUBCOMMITTEE CHAIRS AND VICE CHAIRS 

Subcommittee Chair duties: 

 Appoint a Subcommittee Vice Chair in consultation with Board Chair 

 Consult with the Board Chair regarding Subcommittee appointments 

 Schedule Subcommittee meetings as needed 

 Draft Subcommittee meeting agendas and work agendas in consultation with 

Subcommittee members, the Executive Committee, and NOP staff 

 Convene and preside over Subcommittee meetings 

 Ensure Subcommittee meeting notes are recorded 

 Ensure that Subcommittee meeting notes are reviewed for accuracy 

 Report actions of the Subcommittee to the Executive Subcommittee and Board 

 Serve as mentor/trainer for new Subcommittee Chair during transition periods 

 Designate a liaison to the Materials Subcommittee to collect, compile and present 

the research priorities proposals. 

Subcommittee Vice Chair duties: 

 Provide support in developing and completing Subcommittee work agendas 

 Assist in reviewing Subcommittee meeting notes for accuracy 

 Represent the Chair in the event of the Chair’s absence

 The Vice Chairs of the Crops, Livestock and Handling Subcommittees will serve on 

the Materials Subcommittee as liaisons for reviewing all petitioned substances. 

F. TRANSITION OF SUBCOMMITTEE CHAIRS, VICE CHAIRS, AND MEMBERS (NEW AND 

CONTINUING) 

Subcommittee Chairs shall be appointed to serve annually by the Chair of the Board. 

Vice Chairs and Subcommittee members shall be appointed by their respective 

Subcommittee Chair in conjunction with the NOSB Chair. The annual Subcommittee 

term shall be concurrent with the one-year term established by the Secretary (beginning 

on January 24 and ending the following January 23). Newly appointed Chairs, Vice Chairs 

and Subcommittee members will assume their positions at the beginning of the new 

term, after a period of orientation and mentorship provided by the outgoing Chair, Vice 

Chair, and members. 

To avoid disruption in the quality and volume of work produced by the NOSB, the 

following procedures will be observed: 

After the election of NOSB Officers at the Fall Meeting: 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 121/302
1. The new NOSB Chair takes Office 

Immediately after the election, on the final day of the NOSB meeting, the new Chair 

takes office. 

2. Appointment of Subcommittee Chairs 

The Board Chair appoints Subcommittee Chairs preferably chosen from members 

with at least one year of NOSB experience.

3. Appointment of Subcommittee Vice Chair

Vice Chairs shall be appointed by the incoming Subcommittee Chair, in conjunction 

with the Board Chair. 

4. Timeframe for Appointments 

Subcommittee Chairs shall be appointed by the NOSB Chair and seated within a 

reasonable time after the newly elected NOSB Chair takes office (or continues in 

office), and Vice Chairs shall be appointed by Subcommittee Chairs as soon as 

possible after that. 

5. Review of Subcommittee Files 

New Subcommittee Chairs should review all work agenda items and active files 

involving Subcommittee work 

 

6. Mentorship Period 

The incoming Chair and Vice Chair of each Subcommittee shall participate in an 

orientation and mentorship period with the outgoing Chair and Vice Chair of their 

Subcommittee until seated in their positions at the beginning of the new term on 

January 24. The Board Chair, to facilitate an effective transition for new members of 

the Board and ensure effective participation in Committee and Board deliberations, 

shall ask incoming Board members to identify a mentor from existing Board 

members, or, if the Board member prefers, the Board Chair shall assign a mentor. 

7. Appointment of New NOSB Members: 

The Board Chair will appoint each new NOSB member to appropriate 

Subcommittees as soon as possible, so that on January 24 all Subcommittees are in 

place. The NOSB Chair will consult with outgoing and incoming Subcommittee Chairs 

and other Board officers, with due consideration of the members interest, expertise, 

and background, as well as the composition and needs of the new Board and scope 

of Subcommittee work agendas. Once appointed, incoming Subcommittee members 

shall be included in all email communication pertaining to the Subcommittees on 

which they serve. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 122/302
Changing Subcommittee Appointments 

Board members who would like to join or leave a Subcommittee shall submit a request 

to the Board Chair. If the request does not alter the preferred number of Subcommittee 

members, in the range of five to seven, the expectation is that the request will be 

approved, unless the Board Chair finds that such a change will interfere with the 

functioning of the Subcommittee or the Board. The Chair’s determination should be 

made in consultation with Subcommittee Chairs and the Executive Subcommittee. 

Filling a Subcommittee Chair and/or Vice Chair vacancy

If a Subcommittee Chair position becomes vacant, the Subcommittee Vice Chair shall 

assume the position as Chair and the new Subcommittee Chair shall appoint a new Vice 

Chair in accordance with the consultation procedures cited above. 

G. PROCEDURES FOR COMPLETING SUBCOMMITTEE PROPOSALS AND DISCUSSION 

DOCUMENTS 

1. Development of proposals 

Each of the NOSB Subcommittees will develop proposals, discussion documents or 

reports based on the current work agenda. 

 

 A Subcommittee drafts a proposal or discussion document based on that 

Subcommittee’s work agenda. 

 By a simple majority, the Subcommittee can vote to pass a proposal or discussion 

document to the full Board for consideration at a subsequent NOSB meeting. In 

order to be considered for a vote during an NOSB meeting, all proposals must be 

voted on by the Subcommittee and submitted to the NOP at least forty five (45) 

days prior to a scheduled NOSB meeting. 

 When it is not possible for a Subcommittee, during its regular deliberations on 

conference calls, to reach consensus on a proposed document/recommendation as 

it is being reviewed, and there are substantive irreconcilable differences, a minority 

of the Subcommittee may develop a written minority view for review by all 

members of the Subcommittee. The Subcommittee Chair has the responsibility to 

facilitate the process for the minority view. 

A minority view should: 

o Be short and concise, and include reasons for opposing the Subcommittees 

recommendation; 

o Should not include any data or information not introduced on a 

Subcommittee call; 

o Should be submitted in a timely manner, and will not be accepted after the 

Subcommittee has voted on its recommendation; 

o Will be included as a separate section at the end of the recommendation. 

 The NOP will post the proposal or discussion document for public comment. 

 At any point in the process prior to the Board’s vote, a Subcommittee may convene 

and, by a simple majority, vote to withdraw its proposal from consideration by the 

Board. 

 During a subsequent Board meeting, the Subcommittee presents the proposals and 

discussion documents as well as a summary of public comments and other relevant 

information for discussion and consideration by the full Board. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 123/302
2. Types of Proposals 

 (See Member Guide for examples) 

There are several formats for writing proposals and discussion documents, based on 

the subject under review: 

o Proposals related to material petitions, sunset reviews, annotation changes, or 

classification changes. 

o Proposals for policy or procedure changes 

o Discussion documents 

3. Presenting Subcommittee Proposals and Discussion Documents at NOSB Meetings

NOSB Subcommittees and task forces should follow the outline below when presenting 

proposals or discussion documents for consideration by the Board: 

1. Introduction: A brief summary of the issue or statement of the problem. 

2. Background: An explanation with sufficient detail and rationale to support 

the proposal, including reasons why the proposal should be adopted, 

historical context, and the regulatory framework pertinent to the issue. 

3. Proposal: A concise explanation of the recommended action. 

4. Subcommittee Vote: The Subcommittee vote shall be reported. In the case 

of petitions to add materials to the National List, two votes will be reported; 

one for classification of the material as a synthetic or non-synthetic, and the 

other a motion to list. 

5. Public Comment: A brief summary of the public comments 

6. Minority View: If applicable, the minority view of a Subcommittee or task 

force member shall be reported. After the Subcommittee's proposal has 

been presented and the motion to adopt has been made, it is usual to allow 

the minority to present their views. The minority report is presented for 

information purposes only. If the Board then determines that the minority 

view has merit, it may send the proposal back to Subcommittee for further 

work, since it would be a substantive change to the proposal as presented. 

H. SUBSTANCE/MATERIALS REVIEW PROCESS 

A primary function of the NOSB is “to assist in the development of standards for substances 

to be used in organic production” (OFPA 6518 (a)). “The Board shall develop the proposed 

National List or proposed amendments to the National List for submission to the Secretary 

...” (OFPA 6518(k)). The OFPA also establishes a petition process by which the public can 

request additions or deletions to the National List and also provides for a 5 –year “sunset” 

review by NOSB of all substances on the National List. The Materials Review Process is a 

collaborative effort between the NOP and NOSB. Some phases of the review process are 

handled exclusively by NOP and some by the NOSB. 

The petition process is open to all. Petitions must be filed in accordance with the most 

recent Federal Register notice instructions (currently January 18, 2007 [72 FR 2167]). 

1. Steps in the material review process for a new petition: 

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1. NOP receives a petition, reviews it for completeness and eligibility according to OFPA 

and the petition guidelines. NOP forwards the petition to the appropriate Subcommittee 

with a courtesy copy to the Materials Subcommittee. 

2. Subcommittee (SC) determines if a Technical Review (TR) is needed. 

3. Technical Report is completed and sent to the Subcommittee for review. 

4. TR sufficiency is determined by SC, and the TR is posted on the NOSB website by the 

NOP. 

5. SC reviews substance, develops proposal, discusses proposal and votes, and submits for 

posting 45 days prior to public meeting. 

6. The NOSB members analyze comments and votes on the proposal at the public meeting. 

7. The NOSB Chair delivers the final recommendations to NOP. 

Step 1: Receipt of Petition 

During this phase the NOP will: 

 Notify the petitioner via letter and/or electronic mail of receipt of the petition. 

 Determine whether the petition is complete and whether the petitioned substance is 

eligible for petition under the Organic Foods Production Act and its implementing 

regulations, and whether subject to other agency authority (e.g. EPA, FDA); 

 NOP documents this review using two checklists. 

o OFPA Checklist, NOP 3005-1 

o Petition Checklist, NOP 3005-2 

Ineligible petitions include: 

 Formulated (brand name) products 

 Food additive without FDA approval 

 Pesticide without EPA tolerance or tolerance exemption 

 Requests to add substances already allowed 

 Synthetic macronutrient (e.g., NPK) fertilizers 

 Materials otherwise prohibited by the USDA organic regulations (e.g., sewage 

sludge, GMOs, etc.) 

 Previously petitioned/rejected materials (if no new information is provided) 

Upon determination of completeness and eligibility, NOP will: 

 Notify the petitioner, via letter and/or electronic mail, that the petition is complete 

and eligible; 

 Publish the petition on NOP website; and 

 Notify the NOSB Subcommittee that the substance is being petitioned for addition 

or prohibition from the National List and provide the OFPA and petition checklists. 

 NOP is the primary point of contact for any correspondence between NOSB and 

petitioner 

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Step 2: Determine whether a Third Party Technical Review is required 

During this phase, the applicable NOSB Subcommittee has 60 days to review the petition 

and determine whether a third party technical review is required. This decision is based on 

the following: 

 Is there sufficient information in the petition? 

 Can the Subcommittee reasonably research any needed technical information? 

 Can sufficient information be obtained from public comment? 

 Does the Subcommittee have the expertise needed to address the questions related 

to the petition? This includes impact on the environment, impact on human health, 

and sustainability and compatibility with organic principles. 

If the Subcommittee decides a Technical Review is needed, the Subcommittee Chair will 

make the request to the National List Manager. The SC may also submit questions for 

specific information based on the OFPA evaluation criteria (7 USC 6817(m)), or suggest 

recommended technical expertise. The NOSB may request more information from the 

petitioner if needed. 

If the Subcommittee decides the Technical Review is not needed, the Subcommittee Chair 

will inform the National List Manager. 

In some cases, the Subcommittee may decide the substance is ineligible for the National List 

without need for a Technical Review. In this case, they will develop a proposal to reject the 

substance at the next NOSB meeting, subject to a full board vote. 

A limited scope or supplemental TR may be appropriate when the petition is to amend an 

existing listing, remove a listing, or for purposes of sunset review. 

Option for a Technical Advisory Panel (TAP) 

OFPA states: “The NOSB shall convene technical advisory panels to provide scientific 

evaluation of materials considered for the National List.”(7 USC 6518 (k)(3))

The NOSB has not convened independent Technical Advisory Panels since 2005. Currently 

the NOSB is relying on information within the Technical Reports provided by the NOP and 

public comment to make their final recommendations 

In some cases, NOSB may wish to convene a TAP instead of requesting a TR, for review of 

complex or controversial substances. 

Step 3: Third Party Technical Review 

During this phase the NOP will:

 Assign a contractor to develop a Technical Review (TR) or Technical Advisory Panel 

(TAP). The third party contractor must have technical expertise relevant to the petition, 

and will use the TR template provided by NOP. 

 Review all TRs or TAP reports before they are distributed to the Subcommittee to 

ensure they meet the requirements of the contract. 

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 Ensure that TRs/TAP reports are sufficient and complete when they are distributed to 

the Subcommittee 

Third party experts may consist of contractors, or employees of the USDA, such as AMS 

Science and Technology, AMS Agricultural Analytics Division, Agricultural Research Service, 

or other federal agencies with appropriate expertise, as needed. 

Step 4: Technical Review Sufficiency Determination 

During this phase the Subcommittee (Crops, Livestock or Handling) will: 

Review the draft TR to ensure that it: 

 Is consistent in format, level of detail and tone

 Is technically objective and free from opinions or conjecture 

 Is written in a style appropriate for non-technical readers (e.g. free of technical 

jargon) 

 Is prepared using a well-defined and consistent procedure consisting of 

information gathering, information synthesis and document preparation, and 

quality assurance 

 Is based on the best available information that can be obtained within the 

designated time frame 

 Is thoroughly supported using literature citations

 Addresses all evaluation questions in the TR template 

The Subcommittee chair will notify the NOP, within 60 days of receiving the TR, that the 

TR is sufficient. If the TR is not found sufficient, the Subcommittee must provide the 

NOP with an explanation of why, including a request for additional information or 

improvements. 

If necessary, the NOP will seek improvements or supplemental information from the 

contractor. 

Once the Technical Reports are deemed sufficient, the NOP will post on the NOP 

website. 

Step 5: Review by the Subcommittee (Crops, Livestock or Handling) 

During this phase the Subcommittee conducting the review will: 

 Read the review, along with the submitted petition, and any additional information 

available, such as literature referenced in the Technical Review, personal 

knowledge, and recommendations of a contracted panel of experts when utilized. 

 Subcommittee members will prepare a written review the substance according to 

the OFPA criteria. 

 After discussion, the Subcommittee will vote on classification (e.g., synthetic, 

nonsynthetic, agricultural) for substances not previously classified, and vote on a 

proposed action (e.g., add to National List, remove, or amend) 

 The review, including record of votes, will be finalized as a proposal for the next 

meeting. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 127/302
 All proposals must be submitted to NOP for posting 45 days before the public 

meeting date. 

Step 6: Action by Full NOSB 

During this phase the NOP will: 

 Publish the proposals on the NOP website and provide a minimum of 30 days of 

written public comment on the proposal prior to the public NOSB business meeting. 

 Include sufficient time on the agenda at the NOSB meeting for the Board to discuss 

the proposal, listen to public comments, and make a recommendation. 

At the NOSB meeting: 

 The Subcommittee Chair or delegated lead reviewer for each Subcommittee will 

present the proposals at the NOSB meeting. The proposals are to be presented in 

the form of a seconded motion coming from the subcommittee, and the Chair will 

open the motion for discussion. After discussion board members will vote on the 

motion. 

 Voting may be by show of hands, roll call, or by use of modern voting devices. 

 The NOSB Secretary will record the votes of each NOSB member and the Chair will 

announce whether or not the motion passed. 

2. Changes to annotations or classification of materials.

The NOSB may request to review an existing substance on the National List without a new 

petition when they have justification to support a revision of the annotation or 

reclassification of the substance. This may happen as a result of the sunset review process, 

or based on new information provided in a Technical Review, or from public comment. The 

following procedure should be followed: 

 The Subcommittee sends a written request for a new work agenda item to the 

Executive Subcommittee. 

 The request should include a summary of the issue, brief justification for the 

change, and resources in hand or needed for the project. 

 The ES considers the request and determines if it should go forward. 

 NOP reviews the item for possible addition to the work agenda, and may 

propose to add to a future meeting schedule depending on NOSB workload. 

 The Subcommittee develops a proposal for consideration that is separate from 

the sunset review of the substance. NOP will then consider rulemaking action in 

a timely manner, without constraints due to the sunset timeline. 

3. Additional considerations concerning Technical Reviews

Basic principles that should be considered when consulting with a third party expert: 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 128/302
 A Subcommittee cannot proceed with a recommendation to list a material if it is 

determined that there is insufficient valid scientific information on that material’s 

impact on the environment, human health and its compatibility with organic principles. 

 The decision to request a third party expert needs to be made independently of the 

availability of funds. If there is a lack of funding to secure third party expert advice, the 

Subcommittee has the option to place the review of new petitions on hold. 

 The Subcommittee makes a determination on the completeness of the petition and 

whether a Technical Review is needed. 

 The decision to define the expertise of the third party expert is the responsibility of the 

Subcommittee reviewing the material or issue. 

 To incorporate a diversity of opinions and to minimize the risk of bias, a Subcommittee 

may seek information from a range of technical experts (individuals or institutions). The 

Subcommittee may also ask questions in their posted proposals, in order to gain needed 

information from the public. 

 The NOP will seek Technical Reviews from a range of experts. The name of the 

contracted party will appear on the Technical Review.· All Federal contracts, including 

those issued by USDA/NOP to Technical Report contractors, are governed by the Federal 

Acquisition Regulations (FAR). The FAR includes a “Subpart 3.11—Preventing Personal 

Conflicts of Interest for Contractor Employees Performing Acquisition Functions,” which 

requires contractors to identify and prevent personal conflicts of interest for their 

covered employees. “Personal conflict of interest” means a situation in which a covered 

employee has a financial interest, personal activity, or relationship that could impair the 

employee’s ability to act impartially and in the best interest of the Government when 

performing under the contract.

Link: https://www.acquisition.gov/far/current/pdf/FAR.pdf

4. Definitions

Technical Review - A report prepared by a third party expert under contract addressing 

the environmental, human, and industrial impact of a petitioned material per the OFPA 

and regulatory evaluation criteria to aid in the thorough evaluation of that material by 

the NOSB. 

Technical Advisory Panel (TAP) - Group of third party experts convened by the Board to 

provide a technical review related to a material petition under review by the NOSB. 

V. Prioritization of Petitions 

Petitions received and deemed eligible and sufficient by the NOP/NOSB will be 

prioritized as follows: 

Priority 1: A petition to remove a material presently on the National list that raises 

serious health, environmental, or regulatory concerns, including petitions to reconsider 

previous decisions, will be given the highest priority - Priority 1, above all other 

petitions in the queue of the reviewing Subcommittee (Crops, Handling, or Livestock). 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 129/302
Priority 2: A petition to remove a material presently on the National list not 

based on serious health, environmental, or regulatory concerns, but based on other new 

information, such as commercial availability status, would be assigned a Priority 2, 

behind Priority 1 petitions, but above any petitions to list materials that are in the queue 

of the reviewing Subcommittee (Crops, Handling, or Livestock). This priority assignment 

would include any removal petitions requesting reconsideration of previous board 

decisions, if the resubmitted petition contains substantive new information to warrant 

reconsideration. 

Priority 3: A petition to add a material to the National List will be considered by the 

reviewing Subcommittee (Crops, Handling, or Livestock) in the chronological order in 

which it was received, and will be designated as Priority 3. 

Priority 4: A petition to reconsider adding a material that had previously been rejected 

by a Board vote would be given the lowest priority - Priority 4, and would go to the 

bottom of the Subcommittee (Crops, Handling, or Livestock) queue of petitioned 

materials. Petitions submitted for reconsideration must contain substantive new 

information to warrant reconsideration. 

This prioritization guideline is only that, a guideline. When situations occur beyond the 

control of the reviewing Subcommittee, such as, but not limited to, technical report 

budgetary constraints, or a delay in the delivery of a technical review for a petitioned 

substance, the work agenda may require adjustment by the NOSB and NOP. 

VI. Withdrawal of a petition by a petitioner 

A petition may be withdrawn at any point in the process, prior to the vote by 

Subcommittee. Once a Subcommittee develops a proposal, the outcome will be posted 

for public comment and the NOSB will vote at the next public meeting. When a petition 

is withdrawn by the petitioner prior to Subcommittee proposal, the Subcommittee will 

suspend its review and recommendation procedure. Withdrawals will not be accepted 

after the subcommittee votes on a proposal. 

If a petition is re-submitted, the NOSB will review it in the order in which it was 

received. Thus, a re-submitted petition should be considered a new request and will be 

placed at the end of the queue of materials pending review. 

A petitioner has the opportunity to withdraw a petition with the intent of improving it 

(e.g., conducting additional research), and may also voluntarily submit supplemental 

information. 

VII. Sunset Review Process 

The Organic Foods Production Act of 1990 (OFPA) authorizes a National List of Allowed 

and Prohibited Substances (7 U.S. C. Section 6517). Sections 6517 (e) mandates a Sunset 

Provision as follows: 

o “No exception or prohibition in the National list shall be valid unless the National Organic 

Standards Board has reviewed such exemption or prohibition as provided in this section within 5 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 130/302
years of such exemption or prohibition being adopted and the Secretary has NOSB members 

with diverse backgrounds are recruited to provide balance to the Board. While individual NOSB 

members represent the segments of the population from which they were selected, they also 

represent the greater good of the population as a whole. 

 

 Conflict of Interest 

The NOSB recognizes that members have been specifically appointed to the Board to provide advice 

and counsel to the Secretary concerning policies related to the development of organic standards 

and the creation and amendment of the National List. NOSB members have been appointed because 

they have professional expertise which enables them to advise the Secretary. This professional 

expertise may, at times, present an inherent conflict of interest. To prevent overt advocacy for 

direct financial gain and the appearance of self-interest or the appearance of wrongful activity, the 

NOSB has adopted the following conflict of interest policy. 

 

Be it resolved by the National Organic Standards Board: 

Members of the Board shall refrain from taking any official Board action from which that Board 

member is or would derive direct financial gain. Board members shall disclose their interest to 

the Board and the public, when they or their affiliated business stand to gain from a vote, which 

they cast in the course of Board business. Under certain circumstances, the Board may determine 

whether it is appropriate for the member to vote. 

That members of the Board shall refrain from promoting for consideration any material, process 

or practice for which the member is or would derive direct financial gain arising out of such 

Board action. The act of promoting such material, process or practice shall include private 

discussion with members of the Board advocating the value of the material, public discussion 

and/or written advocacy. 

A "direct financial gain" is defined as monetary consideration, contractual benefit or the 

expectation of future monetary gain to a Board member, including but not limited to, financial 

gain from a party who manufacture distributes or holds exclusive title to a formula for a material 

or product, process or practice. 

 

SECTION II

 

This section provides a description of the composition the NOSB. It also provides a list of 

expectations from members and presents guidelines for conducting business. 

The NOP published a Federal Register notice on Sept. 16, 2013 (78 FR 56811) describing 

current procedures for sunset review. Through the sunset review process, the NOSB can 

recommend to USDA the removal of substances based on adverse impact on human 

health, the environment, or other criteria under the Organic Foods Production Act 

(OFPA). If upon review the NOSB believes the substance no longer fits the criteria for an 

exemption or prohibition, the NOSB can recommend (by a decisive two thirds vote, 7 

USC Section 6158 (i)) to remove the substance from the National List. After the NOSB 

has completed this "sunset" review, the USDA must renew or remove the substances on 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 131/302
the National List to complete the process. All substances under sunset review will be 

considered over two NOSB meetings, to provide ample opportunity for public notice and 

comment. The NOSB observes the following procedure. 

A. Steps in the Sunset Review Process (See Member Guide for forms used in these steps.) 

Step 1: The NOSB Subcommittees submit the initial Sunset List Summary for 

posting which may include requests for specific information. The NOP posts the 

list as well as the NOSB Meeting Announcement in the Federal Register which 

invites comments, at least 30 days prior to the first public meeting on these 

sunset substances. 

Step 2: The public submits written comments, which are analyzed by 

Subcommittees. 

Step 3 (Public Meeting #1): Subcommittees summarize background and public 

comment & receive oral comment. 

Step 4: Subcommittees analyze written and oral comments from Meeting #1 

and prepare a Preliminary Review that includes a motion to remove the 

substance from the National List. The NOP publishes the next meeting 

announcement in the Federal Register, inviting comment on the Preliminary 

Reviews, which are posted on the NOP website. 

Step 5: Written public comments submitted and analyzed by Subcommittees 

Step 6 (Public Meeting #2): Subcommittees present Preliminary Review, 

receive oral comment, and discuss the proposal with the full Board. When 

presented to the full NOSB, reviews will contain a motion and second taken in 

Subcommittee. Motions for removal based on the Preliminary Review are voted 

on by the full Board, and require a decisive two-thirds (2/3) majority to pass. 

o At Meeting #2, the NOSB completes the Sunset Review and submits the 

final documents to the NOP. 

Step 7: AMS reviews the NOSB Sunset Review and considers rulemaking action 

for any recommended removals. This will include a proposed rule open for 

public comment before a final rule amendment is published. 

Step 8: AMS issues Federal Register Notice announcing renewal of applicable 

substances 

Note: this is a regulatory process for determining whether materials already approved 

or prohibited on the National List should be removed. Due to regulatory process 

constraints, it is not possible to modify existing listings, add new uses of a listed 

substance during sunset review, or change annotations. If there is a need to consider 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 132/302
changing an annotation or re-classifying a material, a subcommittee may request to 

develop a separate proposal that will be reviewed separately from the sunset review 

process. Decisions made through the Sunset review should be transparent, nonarbitrary, based on the best current information and in the interest of the organic 

community and public at large. 

VIII. NOSB PROCEDURES 

A. BOARD MEMBER JOB DESCRIPTIONSMEETINGS 

All Board meetings, assembled for the purpose of making recommendations to the NOP, are subject 

to FACA (see appendix B for FACA facts) and as such must be open to the public and must meet 

public notification requirements. Not all meetings are subject to FACA and do not require public 

notification. 

The National Organic Standards Board (NOSB) fulfills three important roles 

 The Board serves as the primary linkage to the organic community. In that regard, the Board must 

advise the NOP on the implementation of OFPA. 

 The Board must approve all materials which appear on the National List. 

 The Board maintains the responsibility to protect and defend the integrity of organic standards. 

Composition of the Board 6518 (b) 

The Board shall be composed of 15 members, of which: 

(1) four shall be individuals who own or operate an organic farming operation; 

(2) two shall be individuals who own or operate an organic handling operation; 

(3) one shall be an individual who owns or operates a retail establishment with significant trade in 

organic products; 

(4) three shall be individuals with expertise in areas of environmental protection and resource 

conservation; 

(5) three shall be individuals who represent public interest or consumer interest groups; 

(6) one shall be an individual with expertise in the fields of toxicology, ecology, or biochemistry; and 

(7) one shall be an individual who is a certifying agent as identified under section 2116 of OFPA. 

[§2119(b)] 

Additionally, the position of Executive Director of the NOSB was added in 2005 to facilitate contact 

between NOP and NOSB 

 BOARD MEMBER STANDARDS 

Participate in meetings—Members must make a commitment to attend meetings 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 133/302
of the Board. Examples of these exempted meetings include: Subcommittee calls, assemblies 

for completing work, planning retreats, training or sharing information. The date and location of 

in-person Board Meetings, currently held twice each year in spring and fall, will to the extent 

possible, be set at the mutual scheduling convenience of the NOSB and the NOP. 



 Serve on committees, as assigned—Each member must be willing to serve on committees as 

assigned by the Chair, and to participate in the work of those committees. 

 Be informed about the decisions to be made—Board members are expected to seek and study the 

information needed to make a reasoned decision and/or recommendation on all business brought 

before the Board. 

 Fully disclose any conflict of interest positions—Members having any commercial or immediate 

family interest that poses a potential or perceived conflict of interest must disclose that conflict to 

the Board and abide by any decision of the Board in dealing with the situation. 

B. CONDUCTING BUSINESS

NOSB public meetings in brief: 

 Approximately 3 days long depending on workload 

 Meetings are held in various venues across the country to allow for participation by 

stakeholders that otherwise may not be able to attend due to travel constraints 

 A typical meeting agenda includes presentations by the NOP, presentations of proposals and 

discussion documents by the NOSB Subcommittees, discussion time and votes on each 

proposal, public comment, NOSB officer elections, and a review of work agendas 

Quorum—: As specified in OFPA, a majority of the members of the Board shall 

constitute a quorum for the purpose of conducting business. [§2119(h)] A majority of the 

members of a Committee, including the Executive Committee,NOSB shall constitute a quorum 

for the purpose of conducting business. (7 USC 6518 (h)). In cases of a medical situation 

preventing attendance in person, a virtual presence is permitted. 

 Decisive votes—: As specified in OFPA, two-thirds (2/3) of the votes cast at a meeting of 

the boardNOSB at which a quorum is present shall be decisive of any motion [§2119(i)]. 

Following Robert’s Rules of Order, all(7 USC Section 6518(i)). All abstentions will be 

recorded as such and will not be included as part of the total vote cast. in case of decisive 

votes. Similarly, all BoardNOSB members who recuse themselves due to conflicts of interest, or 

are absent, shall be recorded as such and their votes will not be counted towards the total 

number of votes cast. Both abstentions and recusals will be considered in order to establish a 

quorum.

SECTION III

 

This section focuses on the responsibilities of the NOSB officers, as well as providing the procedures 

for electing officers, components of the Executive Committee and conducting meetings. 

 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 134/302
 ROLE OF THE EXECUTIVE DIRECTOR 

The Executive Director (ED) of the NOSB is the operational liaison to the National Organic Program. 

The ED is an employee of the U.S. Department of Agriculture and works with the NOP on behalf of 

the Board on a standing basis. 

NOP

NOSB Executive Director

NOSB

The most important function of the ED is to facilitate the operation of the Board, while 

helping to maintain and strengthen its independence. Other specific functions of the ED 

are: 

 Assist in the implementation of policies, goals, objectives, strategic plans, committee work 

plans, and recommendations set by the NOSB and NOP. 

 Draft initial NOSB meeting agendas with NOSB Chair based on committee work plans for NOSB 

and NOP discussion, then finalizes agenda. 

 Coordinate Board and committee meetings, and manage information reporting and 

communications between Board and NOP. 

 Arrange, facilitate, and document in the form of written minutes the NOSB Committee 

conference calls necessary to achieve the most efficient workings of the Board. Minutes are 

distributed to committees for confirmation of accuracy and approval. Committee minutes must 

fully capture the discussion, reflect the diversity of opinions expressed during meetings in order 

that transparency exist and content remain useful for committee members, board members and 

our stakeholder public. 

 Provide training and information to NOSB and task forces on compliance with all pertinent Acts 

and regulations (e.g., FACA, OFPA, NOP), including their role in advising the Secretary. 

 ESTABLISHES AND MONITORS BOARD ADHERENCE TO TIMELINES 

WHICH ENSURE NOP HAS SUFFICIENT TIME TO PUBLISH RELATED 

FEDERAL REGISTER NOTICES AND BOARD/COMMITTEE 

RECOMMENDATIONS THAT MEET DEADLINES FOR public comment. 

 Manage Board calendar and tracking databases in a manner that facilitates 

clarity of activities to the Board and the NOP.

 Work as liaison with NOP staff, TAP & technical review contractors and other government 

agencies (e.g., EPA, FDA, AAFCO). 

 ENSURE BOARD MEMBERS HAVE ALL MATERIALS AND INFORMATION 

NECESSARY TO PROVIDE INFORMED, STRUCTURED AND TIMELY 

RECOMMENDATIONS TO THE NOP FOR PROPOSED AMENDMENTS AND 

GUIDANCE DOCUMENTS TO NOP REGULATION 7 CFR 205. THIS 

INCLUDES THE PROVISION OF PETITIONS, TAP AND TECHNICAL 

REVIEWS, AND HISTORIC DISCUSSIONS OF SUBSTANCES PROPOSED 

FOR INCLUSION ON THE NATIONAL LIST, AS WELL HISTORIC 

DISCUSSIONS AND RECOMMENDATIONS REGARDING ISSUES.

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 135/302
 Maintain executive committee meeting minutes and committee meeting minutes, 

committee records, reports, transcripts, appendices, working papers, drafts, 

studies, agendas and other documents which were made available to or 

prepared for or by the NOSB or its committees, and make such documents 

available for public inspection and copying at the Agency, electronically via the 

World Wide Web; and/or, upon written request in printed form. 

 Prepare and clear Federal Register Meeting Notice and News Release, ensuring 

publication 45 days prior to meeting. 

 Ensure proposed additions to the National List, or other recommendations, are 

posted on the NOSB website for 45 days prior to an NOSB meeting to allow for 

public comment. 

 Provide accurate, clear pre-meeting information to public regarding questions on 

recommendations. 

 Ensure NOSB members have timely access to public comments. 

 Schedule public comment according to issues, and accommodates commenters’ 

travel schedules, where possible. 

 Ensure that Board members and NOP staff at NOSB meetings have access to 

relevant documents related to petitions, materials due to sunset, technical 

reviews, etc. The format could be electronic (CD version) or hard copy. 

 Track recommendations, changes, and votes during meeting to ensure accurate 

meeting transcripts. 

 Assist the NOSB Officers as needed, including scheduling and participating in 

Officer calls, and assisting the Secretary during Board meetings in managing 

public comments, summary of minutes, committee votes, election of officers, 

Board meeting breaks. Also stays apprised and assist as needed in committee 

meetings scheduled before, during and after Board meetings. 

 

 OFFICER RESPONSIBILITIES 

Three principal officers – Chair, Vice Chair and Secretary – guide the Board. 

Chair 

The Chair is responsible to assure the integrity of the Board process, including effectiveness of 

meetings and the board’s adherence to its own rules. The Chair shall: 

 Schedule meetings of the Board and the Executive Committee; 

 Draft meeting agendas in consultation with committee chairs and NOP staff; 

 CONVENE AND PRESIDE AT MEETINGS; 

 Review committee work plans; 

 Review meeting minutes for accuracy, and 

 Assist with the annual election of NOSB officers. 

Vice Chair 

The Vice Chair shall act in the absence of the Chair. The Vice Chair shall serve as a member of the 

Policy Development Committee, and work collaboratively with the PDC’s members on the 

maintenance and upkeep of the Policy and Procedures Manual. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 136/302
Secretary 

The Secretary will work with the NOP Executive Director (ED) to assist in maintaining the integrity of 

all legal and governing documents of the Board. It is the Secretary’s responsibility to help the ED: 

 Make sure official NOSB transcripts are posted for the public; 

 Record all committee votes at NOSB meetings and circulate to the NOSB for approval; 

 Review all additions to the Federal Register to report any discrepancies between Board 

recommendations and those published in the Federal Register; 

 Transfer custody of the Board’s vote records to the Secretary’s successor, and 

 Assist with the annual election of NOSB officers. 

The Secretary may delegate tasks to others, but retains responsibility for the official record. 

Administrative Team 

The Administrative Team consists of the Chair, Vice Chair, Secretary and Executive 

Director. This group may meet on a weekly basis or as needed by teleconference or 

correspond by email in order to coordinate the overall logistics and operations of the 

board, the officer responsibilities noted above, and the overall support provided to the 

Board by the Executive Director. 

A. ELECTION OF OFFICERS 

 

A. NOMINATION 

 

 All INTERESTED NOSB MEMBERS ARE ELIGIBLE FOR CONSIDERATION FOR 

ANY OFFICER POSITION. 

 CANDIDATES MAY BE SELF-NOMINATED OR NOMINATED BY ANOTHER 

MEMBER OF THE BOARD. 

 SHOULD THE CHAIR, VICE CHAIR, OR SECRETARY RESIGN OR FAIL TO 

SERVE THE FULL TERM, THE EXECUTIVE COMMITTEE SHALL APPOINT AN 

INTERIM OFFICER. 

 THE INTERIM OFFICER SHALL SERVE IN THE CAPACITY UNTIL THE NEXT 

REGULARLY SCHEDULED MEETING OF THE BOARD, DURING WHICH AN 

ELECTION WILL BE HELD TO FILL THE REMAINDER OF THE TERM. 

 MEMBERS INTERESTED IN SERVING MORE THAN ONE CONSECUTIVE TERM 

IN AN OFFICER POSITION CAN IF THE BOARD IS IN FAVOR; HOWEVER IT IS 

RECOMMENDED THAT AN OFFICER NOT SERVE FOR MORE THAN TWO 

CONSECUTIVE TERMS. 

 

 B. VOTING SCHEDULE 

 

 OFFICERS SHALL BE ELECTED FOR TERMS OF ONE YEAR BY MAJORITY 

VOTE AT THE ANNUAL FALL MEETING OF THE BOARD. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 137/302
 NEWLY APPOINTED OFFICERS WILL ASSUME THEIR POSITIONS AT THE 

CONCLUSION OF THE FALL BOARD MEETING PURSUANT TO THE 

ELECTION. 

 ACTING BOARD OFFICERS WILL ASSIST THE NEW OFFICERS TO 

TRANSITION INTO THEIR NEW ROLE. 

C. ELIGIBILITY TO VOTE 

 ONLY NOSB BOARD MEMBERS PRESENT ARE ELIGIBLE TO VOTE FOR 

NOMINATED OFFICERS. 

 ABSENT NOSB MEMBERS WILL NOT BE ELIGIBLE TO VOTE. 

 BOARD MEMBERS SHALL BE ENTITLED TO CAST ONE VOTE PER 

NOMINATION. 

D. COUNTING OF VOTES 

 VOTING WILL BE BY BALLOT IMMEDIATELY FOLLOWING NOMINATIONS 

FOR EACH OFFICE. 

 Ballots for officers will be cast in the following order: 

1. Chair 

2. VICE-CHAIR 

3. SECRETARY 

 

 THE BALLOTS WILL BE COUNTED FOR ONE OFFICE AND THE ACTING 

CHAIR WILL ANNOUNCE THE TALLY BEFORE THE NEXT OFFICE IS OPENED 

FOR NOMINATIONS 

 THE ACTING SECRETARY WILL PREPARE AND DISTRIBUTE THE BALLOTS 

AND WILL GATHER THE VOTES BY SECRET BALLOT. 

 THE ACTING CHAIR WILL TALLY THE VOTES AFTER EACH OFFICER 

NOMINATION AND THE ACTING SECRETARY WILL VERIFY THE VOTE 

RESULTS. 

 THE CANDIDATE RECEIVING THE LARGEST NUMBER OF VOTES WILL BE 

ELECTED. 

 IN THE EVENT OF A TIE THERE WILL BE A REVOTE UNTIL A NOMINEE 

OBTAINS MAJORITY. ALL NOMINEES WILL BE INCLUDED IN THE REVOTE

OR MAY BE GIVEN THE OPPORTUNITY THE WITHDRAW AT THEIR 

DISCRETION. . 

 MEMBER VOTE COUNTS WILL REMAIN CONFIDENTIAL. OTHER NOSB 

MEMBERS WILL NOT BE ALLOWED TO DETERMINE HOW THE MEMBERS 

VOTED. 

 VOTES WILL BE DISPOSED OF BY THE CHAIR OR SECRETARY. 

Calculation of Decisive Votes 

# Votes Cast # Recusals and 

Abstentions 2/3 Majority*

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C. PARLIAMENTARY PROCEDURES 

The NOSB adopted the use of Robert’s Rules of Order in March 1992, but modified its use as 

only a non-mandatory guide in May 1993. Roberts Rules may be adapted to meet the special 

requirements of a group. Because the NOSB is also subject to the OFPA, FACA and USDA, a 

designated NOP staff member may act as an informal Parliamentarian to advise the Chair.

D. NOSB DELIBERATIONS AND RECOMMENDATIONS 

Board actions include but are not limited to: adoption of a proposal as presented by the 

Subcommittee, non-substantive amendments* and then adoption of a proposal, rejection of a 

proposal, or referral of the proposal back to Subcommittee for further development. 

* Substantive vs. non-substantive amendments. 

The following criteria shall be considered when determining if a proposal will be amended at the 

NOSB meeting, or must be referred back to Subcommittee and resubmitted for the next Board 

meeting. The DFO or designee will determine whether a proposed amendment to a proposal is 

substantive. 

 The extent to which a reasonable person affected by the recommendation would have 

understood that the published proposal would affect his or her interests 

 The extent to which the subject of the recommendation or the issues determined in it are 

substantially different from the subject or issues involved in the proposal 

 The ACTING SECRETARY WILL RECORD NEWLY ELECTED OFFICERS INTO 

THE NOSB MEETING SUMMARYEXTENT TO WHICH THE EFFECTS of MINUTES. 

EXECUTIVE COMMITTEE 

 

 The Executive Committeethe recommendation differ from the effects of the NOSB 

shall be comprised of the Chair, Vice Chair, Secretary, and the chairs of the 

standing committees. The Executive Committee, with participation of the 

NOP, shall meet monthly, as needed, or as called by the Chair, and shall 

conduct business on behalf of the Board. Only the full Board may take 

decisive action on guidance and other policy recommendations from 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 139/302
committees, including the status of materials proposed for addition or deletion 

on the National List. The Executive Committee will provide guidance and 

feedback to Committees on their proposed work plans.proposal

 

MEETINGS 

 

All Board meetings, conference calls, and bulletin board assembled for the purpose of making 

recommendations to the NOP are subject to FACA (see appendix B for FACA facts), In particular, 

these must be open to the public and must meet public notification requirements. Not all meetings 

are subject to FACA and do not require public notification. Examples are: assemblies for completing 

work, planning retreats, training and sharing information. At this time, full Board conference calls or 

full Board assembly via electronic bulletin board are not permitted. The date and location of 

periodic full in person Board Meetings (normally twice a year), will to the extent possible, be set by 

consensus of the Board in consultation with the NOP. 

 

 SECTION IV 

BOARD COMMITTEES

 

Committees play an important role in administering the Board’s responsibilities. Committees exist to 

provide greater depth and clarity in the Board’s responsibility to make informed decisions. For 

example, at the request of the Secretary seeking advice on a matter related to the NOP, the full 

Board may request that a committee conduct research and analysis or draft proposed 

recommendations to be considered by the full Board. Except for the Executive Committee, no 

committees are authorized to act in place of the Board. Committees are empowered to analyze 

information and bring draft recommendations to the Board for action. 

 

Committee chairs are appointed by the Board Chair. The current standing committees are: 

 Certification, Accreditation, and Compliance 

 Crops 

 Handling 

 Livestock 

 Materials 

 Policy Development 

The Livestock Committee, the Crops Committee and the Handling Committee will each have cochairs. One co-chair will guide all committee discussion and will oversee the committee’s work plan. 

The other co-chair will be responsible for the committee’s consideration of materials and will serve 

as the liaison to the Materials Committee. 

 

1. Committee recommendations are finalized by the NOSB according to the following process: 

2. Committee drafts the recommendation. 

3. Draft recommendation is posted for public comment. 

4. Public comments are considered by committee when making recommendation to the Board. 

5. Board takes action on the recommendation 

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Board actions may include adoption of the recommendation as presented by the committee, 

amending and then adopting the recommendation, rejecting the recommendation, or referring the 

recommendation back to committee for further development. 

 

COMMITTEE MEETINGS 

 

Committees may hold meetings via telephone conference calls. Two weeks’ notice should be 

provided in scheduling such calls. The date and time set for the call is a product of committee dialog 

regarding the most conducive schedule. This dialog may occur on a previous conference call or 

through E-mail. All E-mail requests for meeting times should allow 48 hours to respond. 

 

Emergency calls may be scheduled with less notice only after each member is contacted to reach a 

consensus on time and date of the meeting. If the members do not respond to E-mail requests, the 

chair or their designee must contact the member by phone. 

 

STANDING COMMITTEES 

Certification, Accreditation, and Compliance Committee (CACC) The Certification, Accreditation, 

and Compliance Committee drafts recommendations for consideration by the Board to provide 

guidance, clarification or proposed standards of certification, accreditation and compliance sections 

of the organic regulations [7CFR Part 205] and OFPA. The CACC occasionally works with other 

committees to develop joint recommendations where certification and compliance issues are 

involved. 

 

Crops Committee (CC) The Crops Committee drafts recommendations for consideration by the 

Board to provide guidance, clarification or proposed standards of the crop production section of the 

organic regulations as contained in [7CFR Part 205] and OFPA. The CC reviews petitions, substances 

scheduled to sunset, technical advisory panel reports, and public comments concerning materials 

used for crop production which have been requested for addition to or removal from the National 

List. The CC occasionally works with other committees to develop joint recommendations where 

crop issues are involved. 

 

Handling Committee (HC) The Handling Committee makes draft recommendations for 

consideration by the Board to provide guidance, clarification or proposed standards of the handling 

and labeling sections of the organic regulations as contained in [7CFR Part 205] and OFPA. The HC 

reviews petitions, substances scheduled to sunset, technical advisory panel reports and public 

comments concerning materials used for processing and handling which have been requested for 

addition to or removal from the National List. The HC occasionally works with other committees to 

develop joint recommendations where handling issues are involved. 

Livestock Committee (LC) The Livestock Committee drafts recommendations for consideration 

by the Board to provide guidance, clarification or proposed standards of the livestock and livestock 

feed sections of the organic regulations as contained in [7CFR Part 205] and OFPA. The LC reviews 

petitions, substances scheduled to sunset, technical advisory panel reports and public comments 

concerning materials used for livestock production which have been requested for addition to or 

removal from the National List. The LC occasionally works with other committees to develop joint 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 141/302
recommendations where livestock issues are involved. 

Materials Committee (MC) The Materials Committee drafts recommendations for consideration 

by the Board to provide guidance, clarification or proposed standards of the National List section of 

the organic regulations as contained in [7CFR Part 205] and OFPA. The MC works with the NOP, 

NOSB Committees and TAP Contractors in managing the Materials Review Process including tracking 

petitions, sufficiency reports, materials scheduled to sunset and sunset review process In addition to 

a chair appointed by the Board Chair, the MC shall include in its membership one of the co-chairs 

from each of the Livestock, Crops, and Handling committees. Other members may be appointed as 

needed. The MC occasionally works with other committees to develop joint recommendations 

where materials are involved. 

Policy Development Committee (PDC) The Policy Development Committee makes draft 

recommendations for consideration by the Board to provide guidance, clarification or proposed 

standards of Board operations, policies and procedures. The PDC maintains the content and updates 

to the NOSB Policy and Procedures Manual (in collaboration with the NOSB Vice Chair) and New 

Member Guide. The PDC occasionally works with other committees to develop joint 

recommendations where policy issues are involved. 

A. TASK FORCES 

As determined by the Board or Executive Committee, task forces shall be appointed to 

explore specific issues and present draft recommendations to the Board or to a 

committee. Task forces may include non-Board members of the public. Each task force 

shall include at least one member of the NOSB. Minutes shall be taken of task force 

meetings. Each task force shall submit a final report to the Board. Each task force shall 

be disbanded when its work has concluded or when the Board determines the task 

force is no longer necessary. 

Procedure for submitting final recommendations to NOP 

Within 30 days after the completion of the NOSB meeting all final 

AD HOC COMMITTEES 

At the discretion of the NOSB Chairperson, with approval of the Executive Committee, an ad hoc 

NOSB committee may be formed to develop policy and guidance on specific issues that involve 

multiple standing committee jurisdictions, or for issues or tasks that are very large and require 

additional resources to complete. Ad hoc committees may be comprised only of current NOSB 

members, and could either be a combination of two or more standing committees to form a “joint” 

committee, or could be a totally new committee comprised of selected NOSB members from various 

standing committees. Ad-hoc committees can be dissolved at the recommendation of the NOSB 

chairperson with the approval of the executive committee. The position of the ad-hoc committee 

chairperson is a non-voting member of the executive committee. 

 SECTION V 

 

This section defines the responsibilities of the different committee chairs and respective vice chairs. 

It also provides indications on writing committee recommendations and presenting such 

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recommendations for vote at NOSB meetings, Lastly, this section covers general and specific 

collaboration procedures between NOSB and NOP. 

 DUTIES OF COMMITTEE CHAIRS 

Committee chairs are responsible for the following duties: 

 Schedule committee meetings as needed. 

 Draft committee meeting agendas and work plans in consultation with committee members, the 

Executive Committee, and NOP staff. 

 Convene and preside committee meetings. 

 Ensure committee meeting minutes are recorded. 

 Review committee meeting minutes for accuracy. 

 Report actions of the committee to the Board. 

 Name a committee vice-chair. 

 Serve as mentor/trainer for new committee chair during transition periods. 

Committee chairs shall not act unilaterally, especially concerning issues which involve statutory 

responsibilities of the Board. 

 DUTIES OF COMMITTEE VICE-CHAIRS 

Committee vice-chairs are responsible for the following duties: 

 Provide support in developing and completing committee work plans. 

 Assist in reviewing of committee meeting minutes for accuracy. 

 Represent the committee chair in the absence of the chair. 

 Vice Chairs of the Crops, Livestock and Handling Committees will serve on the Materials 

Committee as liaison for reviewing all petitioned substances. 

Committee vice-chairs shall not act unilaterally, especially concerning issues which involve statutory 

responsibilities of the Board. 

 PROCEDURES FOR THE TRANSITION OF COMMITTEE CHAIRS, 

VICE-CHAIRS, AND MEMBERS 

Committee Chairs, Vice-Chairs and members shall be appointed to serve annually by 

the Chair of the Board. The annual committee term shall be concurrent with the oneyear term established by the Secretary (beginning on January 24 and ending on the 

following January 23). Newly appointed Chairs, Vice-Chairs and committee members 

will assume their positions at the beginning of the new term, after a period of orientation 

and mentorship provided by the outgoing Chair, Vice-Chair, and members. 

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In order to avoid disruption in the quality and volume of work produced by the NOSB, the 

appointment of committee chairs will follow these procedures during the following transition times: 

AFTER ELECTION OF NOSB OFFICERS AT FALL NOSB MEETING: 

 APPOINTMENT OF COMMITTEE CHAIRS 

THE BOARD CHAIR SHOULD APPOINT COMMITTEE CHAIRS FROM 

MEMBERS WITH AT LEAST ONE YEAR OF NOSB EXPERIENCE, IDEALLY. IT IS 

RECOMMENDED THAT A NEW COMMITTEE CHAIR SHOULD HAVE 

EXPERIENCE AS COMMITTEE VICE-CHAIR. 

 Appointment of Committee Vice-Chairs 

A Committee Vice-Chair shall be appointed by the Committee Chair and should be 

someone who has expressed to the Chair of the Committee interest in eventually 

serving as Committee Chair. 

 Time Frame for Appointments 

Committee Chairs shall be appointed as Incoming Chairs in not more than 30 days 

after the newly elected NOSB Chair takes office (or continues in office), and 

incoming Vice-Chairs shall be appointed by Committee Chairs in no more than two 

weeks after that. 

 Exchange of Committee Files 

Upon appointment, new and outgoing Committee Chairs should have a formal 

meeting to exchange all files related to the committee’s work and to complete the 

first committee work plan under the new committee leadership. 

 Review of Committee Files 

New Committee Chairs should review all work plan items and active files involving 

committee work. 

 Mentorship Period 

The Incoming Chair and Vice-Chair of each committee shall participate in an 

orientation and mentorship period with the outgoing Chair and Vice-Chair of their 

committee until being seated in their positions at the beginning of the new term on 

January 24.

After the Appointment of the New NOSB Members (prior to January 24): 

 New Committee Member Appointments 

New incoming committee members shall be appointed by the Board Chair, in 

consultation with the outgoing and incoming committee Chairs, no more than two 

weeks after the appointment of the new NOSB members by the Secretary, with the 

Chair seeking and taking into account the expressed member interest, expertise, 

background, as well as new board composition. 

 Communication with Newly Appointed Members 

Once appointed, incoming committee members shall be included in all emails 

pertaining to the committee assignments. 

 Attendance at Committee Meetings and Fall NOSB Meeting 

New incoming members of the committee should participate in observer status in 

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committee meetings upon their appointment, and should be encouraged to attend 

the Fall Board meeting. 

 New Member Mentorship 

The Board Chair, to facilitate an effective transition for new members of the Board 

and ensure effective participation in committee and board deliberations, shall ask 

incoming Board members to identify a mentor from existing Board members as soon 

after their appointment as possible, but no later than two weeks, or, if the Board 

member prefers or the Board member takes no action, the Board Chair shall assign 

a mentor in same time frame. 

Between Board Appointments and Fall Board Meeting: 

 Changing Committee Appointments 

If a Board member would like to change committees, either adding to or stepping 

down from his/her assignments, a request shall be made to the Board Chair. If the 

request does not alter the preferred number of committee members in the range of 

five to seven, the expectation is that the request will be approved, unless the Board 

Chair states in writing that such change will interfere with the functioning of the 

committee. The Chair’s determination should be made in consultation with Committee 

Chairs and the Executive Committee. 

 Filling Vacancy of Committee Chair and/or Vice-Chair 

In the case of a vacancy in the positions of Committee Chair, the Committee ViceChair shall assume the Committee Chair position and the new Committee Chair shall 

appoint a new Vice-Chair in accordance with the consultation procedures cited 

above. 

 PROCEDURES FOR COMPLETING COMMITTEE 

RECOMMENDATIONS 

Developing committee recommendations follows these broad steps: 

1. THE COMMITTEE PREPARES A RECOMMENDATION OR DISCUSSION 

DOCUMENT AS AGREED TO IN THE COMMITTEE WORK PLAN (SEE P. 32 

PPM). 

2. THE RECOMMENDATION OR DISCUSSIONS DOCUMENT IS POSTED FOR 

PUBLIC COMMENT. 

3. DURING THE BOARD MEETING, THE COMMITTEE PRESENTS ITS 

RECOMMENDATION FOR DISCUSSION BY THE FULL BOARD. 

4. AT ANY POINT IN THE PROCESS PRIOR TO THE BOARD’S VOTE ON THE 

STATUS OF THE RECOMMENDATION, THE PRESENTING COMMITTEE MAY 

CONVENE AND VOTE TO WITHDRAW ITS RECOMMENDATION, BASED ON 

APPROVAL OF THIS ACTION BY THE MAJORITY OF THE MEMBERS OF THE 

COMMITTEE. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 145/302
5. ONCE PRESENTED, THE BOARD VOTES ON THE COMMITTEE 

RECOMMENDATION. 

In order to be considered a voting item, all recommendations must be submitted to the 

NOP at least forty five (45) days prior to a scheduled NOSB meeting. This time is 

needed in order to allow the Program to publish a meeting notice and allow for 

public comment. using the following procedure: 

The Board may takeEach proposal lead prepares the following actions for each 

committee documents: 

o A recommendation: cover sheet (See Member Guide). The cover sheet should 

contain all appropriate information, including the vote recorded at the meeting. 

(The NOP can provide the voting record)

1. Adopt the recommendation as presented by the committee; 

2. Amend and adopt the amended recommendation; 

3. Reject the recommendation; or 

4. Refer the recommendation back to the committee for further development. 

Writing Committee Recommendations 

This section provides an outline to be used by committees in writing a recommendation document. 

These guidelines not only allow consistency in the content of NOSB recommendations, but should 

also provide the NOSB, and the public, a fast manner to weigh the advantages and disadvantages of 

a proposal. 

Recommendations not related to material petitions or sunset reviews, should include the following 

sections: 

I. Introduction: 

This section consists of a brief summary of the recommendation, its main issues and its relevance to 

the organic community. This section should also mention the goals and intent of the proposed 

recommendation. 

II. Background: 

This section should present the issues that justify the development of the recommendation as well 

as any relevant work done by the NOSB in the past. 

III. Relevant areas in the Rule: 

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This section should mention any areas of the Rule or OFPA which provide the basis for the 

recommendation. 

IV. Discussion: 

This section should be used to expand on the intent of the recommendation. It is also a place to 

emphasize the SWOT of the recommendation (strength, weaknesses, opportunities and threats). No 

recommendation is 100% perfect and this section can serve to clarify the tradeoffs and advantages 

of a recommendation. Thus, it is advisable to mention all major alternatives reviewed by the 

committee. If appropriate, different stakeholders groups should be identified indicating how each 

group’s needs are met or affected. 

V. Recommendation: 

This is the core, or deliverable, of the recommendation. 

VI. Committee Vote: 

This section should present the names of the members who moved and second the motion to 

approve the recommendation. As a norm, a motion should always be presented in the 

affirmative. In the case of recommendations for petitions to add materials to the National List, 

two votes should be taken and recorded, the first for a synthetic or non-synthetic material 

classification, and the second to list or not list the material. The record should list the number of 

synthetic and non-synthetic votes, yes and no votes for listing, and the number of abstentions 

and absences. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 147/302
Minority opinion: 

If applicable, the dissenting opinion(s) of committee or task force members shall be reported. A 

member of a committee can present a minority report to the committee recommendation. Such 

document should include reasons for opposing a proposed recommendation and cite where the 

opposition points are in the recommendation. In addition, the minority report could, provide 

alternative approaches or solutions from those given in the recommendation, or recommend an 

amendment to the recommendation. The minority opinion will be included as a separate document 

at the end of the recommendation. 

Recommendations related to material petitions or sunset reviews, should include the following 

sections: 

I. List: This section identifies the placing of the material under review within the National List. Any 

annotations related to the material should be included. 

II. Committee Summary: This section should present a brief background of the material under review 

highlighting its uses and past NOSB decisions. It should include a short description of any current 

research done by the committee (e.g., review of technical reports, individual investigation, etc.) and 

should provide a description of the main arguments supporting the committee’s final decision. This 

section should mention any areas of the Rule or OFPA which provide the basis for the 

recommendation. 

III. Committee Recommendation: The committee recommendation should be stated clearly here 

including any corresponding annotation. 

IV. Committee Vote: This section should present the names of the members who moved and second 

the motion to approve the recommendation and vote count. As a norm, a motion for a petitioned 

material or sunset review should always be presented in the affirmative. 

Minority opinion: 

Presenting Committee Recommendations at NOSB Meetings 

NOSB committees and task forces will follow the outline presented below in order to present draft 

policy and/or material recommendations for consideration by the Board: 

I. Introduction: A brief summary of the issue or statement of the problem. 

II. Background: An explanation with sufficient detail and rationale to support a proposed 

recommendation, including reasons why the recommendation should be adopted, historical 

context, and the regulatory framework pertinent to the issue. 

III. Recommendation: The concise text of the recommended action. 

IV. Committee vote: The vote of the committee or task force shall be reported. In the 

case of recommendations for petitions to add materials to the National list, two votes will 

be recorded, one for synthetic or non-synthetic material classification, and the other for 

listing or not. 

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V. Minority opinion: If applicable, the dissenting opinion(s) of committee or task force members shall be 

reported. 

 

 NOSB-NOP COLLABORATION 

 

The Organic Foods Production Act (6518 (a)) directed the Secretary of Agriculture to establish a 

National Organic Standards Board to assist in the development of standards for substances to be 

used in organic production and to advise the Secretary on any other aspects of the implementation 

of the Act. In 6503 (a) of the Act, the Secretary was directed to establish an organic certification 

program. The National Organic Program (NOP) has become the governmental institution to 

accomplish this and is the means through which the NOSB provides advice and assistance to the 

Secretary of Agriculture. 

The mutual goals to advance the integrity of organic products, principles and products can best be 

accomplished through team work and cooperation between the NOSB and the NOP and is 

implemented regularly through two-way feedback by the NOSB Executive Director and periodically 

at the Executive Committee’s monthly calls. Especially at these calls, NOSB committee work plans 

and priorities are discussed and NOP requests and opinions are aired. 

 

An effective collaboration process between the NOP and the NOSB should ensure that NOP receives 

NOSB input and feedback, and vice versa. The process can be complicated due to several factors 

like the following: 

 The NOSB is a FACA advisory committee, and as such, must conduct business in the open, under 

the requirements of P.L. 94-409, also known as “Government in the Sunshine Act” (5 

U.S.C.552b). 

 The USDA cannot delegate its authority as a regulatory body to private citizens, even when 

those private citizens are appointed by the Secretary to provide advice. However, the NOSB has 

unique statutory authority related to the determination of materials as approved or prohibited 

substances for inclusion on the National List. 

 The NOSB cannot direct USDA or bind the Secretary through its actions; for example, it cannot 

obligate funds, contract, or initiate policies on its own accord. 

Several collaboration approaches may be required depending on the type of issue faced by the 

Board. Below are descriptions of the most common situations faced by the NOSB. In all cases, the 

end product should be a recommendation by the Board to the NOP and each recommendation 

should be accompanied by a cover sheet illustrated in figure 1. 

1. Materials proposed to be added to or removed from the National List. 

The NOSB has the statutory authority to consider and recommend materials for addition to, or 

deletion from, the National List of Approved and Prohibited Substances, or to add, remove, or 

modify annotations restricting the use of such listed materials. 

2. Recommendation for modification of existing standards or new standards. 

The NOSB will use the decision making procedures outlined in Section VIII to justify modifying 

existing standards or proposing new standards. The NOP may request that the NOSB develop 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 149/302
recommendations for new or existing standards. The request should be in writing and should 

include a statement of the problem to be addressed, background, including the current policy or 

situation, statuatory/ regulatory authority, legal situation, and desired timeframe for receiving 

the recommendation. The request will be posted on the NOP web site.

o Providing adviceThe proposal that was voted on NOP policyat the meeting 

The proposal leads will forward the documents to the appropriate Subcommittee Chair 

who will review them for accuracy and interpretationcompleteness, sign and date 

them, and then forward them to the Board Chair and the DFO/ACS. 

E. PUBLIC COMMENT 

The NOP and NOSB encourage public comment and work collaboratively to increase 

opportunities for greater participation by a broad range of standards. 

An examples people, employing various modes of communication and modern technology 

whenever possible. Individuals may present oral comment at either a pre-meeting 

electronic webinar or at the in-person NOSB meeting. 

Before Public Meetings: 

3. Written comment: All members of the public are: NOSB providing encouraged to submit 

public comment in writing according to the Federal Register Notice. Written submissions: allow 

NOSB members the opportunity to read comments on specific actions by the NOP, such as the 

yeast and compost policies.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. 

4. Compliance and Enforcement. 

The NOP is responsible for compliance and enforcement. The NOP welcomes NOSB input on 

standards, but NOSB involvement in active investigations or enforcement actions is not 

appropriate. As timely and appropriate, the NOP reports to NOSB on the status of enforcement 

actions and also posts the status on the NOP web site. 

5. Management Review. 

NOSB may review the quality management system and internal audits to ensure that the NOP is 

managed effectively and efficiently. For example, the NOSB has a role to play in terms of seeing that 

corrective actions with OIG are completed. 

In all the above situations, FACA procedures must be carefully followed to provide transparency and 

necessary public input. 

The primary means of collaboration will be through NOP participation in Executive Committee (EC) 

and Standing Committee calls. The NOP Deputy Administrator or designee will participate in all EC 

calls. The NOSB Executive Director (ED) will participate in all NOSB calls as described in the ED duties 

in the PPM. Upon request and mutual agreement, the Deputy Administrator will participate in 

Standing Committee calls. In addition, each Standing Committee will be assigned an NOP staff 

person to provide additional technical, legal, and logistical support. 

Work plans for action items are developed for each upcoming public board meeting. This is the 

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mode for developing recommendations and discussion documents. Work plan procedures are 

described in detail in Section VIII, page 32. The proposed work plans are presented and discussed at 

each public board meeting, but may be revised based on comments and Board priorities and 

resources. 

NOP publicly made requests at board meetings are important considerations in the development of 

Committee work plan. These NOP requests to NOSB will be followed up in writing stating the 

problem to be addressed, background, statutory authority and the time frame for response. The 

proposed Committee Work plans will be reviewed at the next EC call following the Board meeting, 

with participation by the NOP Deputy Administrator. This participation in the development of work 

plans is vital for effective NOSB/NOP collaboration. Due to change in circumstances, these work 

plans may need to be revised prior to the posting of the final agenda of the upcoming Board 

meeting. Committee work plan changes will be done in consultation and full knowledge of the EC 

and NOP.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 151/302
Figure 1: Form Used to Submit NOSB Final Recommendations to the NOP

(Non Materials Recommendations) 

 

Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program (NOP)

Date: __________

Subject: __________

Chair: __________

 

 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action __________

Guidance Statement __________

Other __________

Statement of the Recommendation (Including Recount of Vote): 

 

Rationale Supporting Recommendation (including consistency with 

OFPA and NOP): 

Committee Vote:

Moved: __________ Second: __________

Yes: __ No: __ Abstain: __ Absent: __ Recusal: __

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 152/302
 

 SECTION VI 

MISCELLANEOUS POLICIES 

 

NOSB Policy for Presenters Invited by Committees 

 

 Need for presentation established within the appropriate committee by the committee chairperson. 

 The committee chairperson should notify the NOSB Chair with a request to issue an invitation at 

least 45 days prior to meeting. Exceptions are at the discretion of the NOSB Chair. 

 Presenter(s) must be invited by committee chair and/or NOSB Chair and approved by the NOSB 

Chair. 

 Reason(s) for presentation, subject area and bio/resume of presenter(s) to be circulated via email to 

entire board at least 2 weeks prior to meeting. 

 Invited presenter(s) must provide objective information. 

 Presenter(s) cannot be a petitioner on the topic under discussion. 

 Presenter(s) must disclose any actual or perceived conflict of interest including information 

concerning who provided funding for the presentation. 

 

NOSB Policy for Surveys Conducted on Behalf of NOSB Committees 

1. All surveys, including electronic surveys, conducted in the name of any NOSB Committee, must be 

approved by the NOSB Executive Committee before they are submitted for approval to USDA, which 

must submit for approval to the Office of Management and Budget (OMB); and 

2. A written report summarizing the results of the survey must be submitted to the full Board and the 

NOP as soon as possible after completion. 

Public Comment at NOSB

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 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 153/302
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. However, the NOSB will attempt to accommodate all persons 

requesting public comment time. 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. AdvanceWritten 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. 

 Persons must give their names and affiliations for the record at the beginning of their public 

comment. 

 Proxy speakers are not permitted. 

 Persons must give their names and affiliations for the record at the beginning 

of their public comment. 

 Proxy speakers are not permitted. 

 Public comment requestscomments may be scheduled according to topic. 

 Individuals providing public comment willshall refrain from making any personal attacks 

and fromor remarks that otherwisemight 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.

 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 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 154/302
comprehensible understanding of the speaker’s concerns.

Adopted October 17 2012; 15 yes, 0 no, 0 absent, 0 abstain, 0 recuse 

 

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.

F. ELECTION OF OFFICERS 

Nominations 

 Any NOSB member is eligible for consideration for any officer position 

 An NOSB member may self-nominate or may be nominated by another member of the 

NOSB 

 Should the Chair, Vice Chair, or Secretary resign or fail to serve the full term, the Executive 

Subcommittee shall appoint an interim officer. The interim officer shall serve in that 

capacity until the next regularly scheduled meeting of the NOSB, during which an election 

will be held to fill the remainder of the term 

 Members may serve more than one term in any officer position.

Voting schedule 

 Officers shall be elected for one-year terms by majority vote at the fall NOSB meeting. 

 Newly elected officers will assume their positions at the conclusion of the fall NOSB 

meeting, and assume the responsibilities thereof at that time 

 Outgoing NOSB officers will assist the incoming officers with the transition into their new 

roles, to be completed no later than January 23rd of the following year. 

 Counting of Votes 

 Voting will be by secret ballot immediately following nominations for each office 

 Ballots for officers will be cast in the following order: 

1. Chair 

2. Vice Chair 

3. Secretary 

 Ballots will be counted for one office and the Secretary will announce the tally before the 

next office is opened for nominations 

 The Secretary and Vice chair will prepare and distribute the ballots, then collect them after 

each vote 

 The Secretary will tally the votes after each officer nomination and the Chair will verify the 

results 

 The candidate receiving the greatest number of votes will be elected 

 In the event of a tie there will be a revote until a nominee obtains a majority. All nominees 

will be included in the revote or may be given the opportunity to withdraw at their 

discretion 

 Votes will remain confidential, and ballots will be disposed of by the Chair or Secretary. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 155/302
G. MISCELLANEOUS PROCEDURES 

 

1. Invited Speakers 

 Subcommittees, the NOSB or the NOP may identify the need for presentations and 

speakers regarding subjects of interest or concern to be addressed at NOSB meetings. 

 Requests must be made by the NOSB chair to the NOP no less than 60 days prior to the 

target NOSB meeting. 

 Speakers must be approved and invited by the NOP. 

If approved by the NOP, the purpose for the presentation, the subject area and the 

bio/resume of speaker(s) should be circulated via email to the entire Board at least 2 

weeks prior to the Board meeting. 

Current petitioners cannot be invited to be speakers about the topic under discussion, 

unless invited by the NOSB Chair. 

Speakers are expected to disclose any financial interests that he or she has that can be 

reasonably assumed to influence his or her presentation content. 

2. Surveys Conducted on Behalf of NOSB Subcommittees 

 All surveys, including electronic surveys, conducted on behalf of the NOSB, must be 

approved by the NOSB Executive Subcommittee before they are submitted for approval 

to USDA, and 

 A written report summarizing the results of the survey must be submitted to the full 

Board and the NOP as soon as possible after completion.

IX. REVISIONS TO THE POLICY AND PROCEDURES MANUAL 

 The PDS will review the PPM each year and, working in collaboration with the NOP, determine if 

any updates are necessary. 

 Proposed changes will be subject to review and approval by the NOP and the full NOSB. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 156/302
APPENDICES Adopted April 11 2013; 15 yes, 0 no, 0 absent, 0 abstain, 0 recuse 

 SECTION VII 

 

X.

A. Appendix 1: FOUNDATIONS 

1. NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING 

 

(NOSB Recommendation Adopted October 17, 2001)

1.1 1.1 Organic agriculture is an ecological production management system that promotes and 

enhances biodiversity, biological cycles, and soil biological activity. It emphasizes the use of 

management practices in preference to the use of off-farm inputs, taking into account that 

regional conditions require locally adapted systems. These goals are met, where possible, 

through the use of cultural, biological, and mechanical methods, as opposed to using synthetic 

materials to fulfill specific functions within the system. 

1.2 

1.2 An organic production system is designed to: 

1.2.1 Optimize soil biological activity; 

1.2.2 Maintain long-term fertility; 

1.2.3 Minimize soil erosion; 

1.2.4 Maintain or enhance the genetic and biological diversity of the production system and 

its surroundings; 

1.2.5 Utilize production methods and breeds or varieties that are well adapted to the region; 

1.2.6 Recycle materials of plant and animal origin in order to return nutrients to the land, thus 

minimizing the use of non-renewable resources; 

1.2.7 Minimize pollution of soil, water, and air; and 

1.2.8 Become established on an existing farm or field through a period of conversion 

(transition), during which no prohibited materials are applied and an organic plan is 

implemented. 

1.3 The basis for organic livestock production is the development of a harmonious relationship 

between land, plants, and livestock, and respect for the physiological and behavioral needs of 

livestock. This is achieved by: 

1.3.1 Providing good quality organically grown feed; 

1.3.2 Maintaining appropriate stocking rates; 

1.3.3 Designing husbandry systems adapted to the species' needs; 

1.3.4 Promoting animal health and welfare while minimizing stress; and 

1.3.5 Avoiding the routine use of chemical allopathic veterinary drugs, including antibiotics.

 

1.4 Organic handling practices are based on the following principles: 

1.4.1 Organic processors and handlers implement organic good manufacturing and handling 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 157/302
practices in order to maintain the integrity and quality of organic products through all 

stages of processing, handling, transport, and storage; 

1.4.2 Organic products are not commingled with non-organic products, except when 

combining organic and non-organic ingredients in finished products which contain less 

than 100% organic ingredients; 

1.4.3 Organic products and packaging materials used for organic products do not come in 

contact with prohibited materials; 

1.4.4 Proper records, including accurate audit trails, are kept to verify that the integrity of 

organic products is maintained; and 

1.4.5 Organic processors and handlers use practices that minimize environmental degradation 

and consumption of non-renewable resources. Efforts are made to reduce packaging; 

use recycled materials; use cultural and biological pest management strategies; and 

minimize solid, liquid, and airborne emissions. 

1.5 Organic production and handling systems strive to achieve agro-ecosystems that are 

ecologically, socially, and economically sustainable. 

1.6 Organic products are defined by specific production and handling standards that are intrinsic 

to the identification and labeling of such products. 

1.7 Organic standards require that each certified operator must complete, and submit for 

approval by a certifying agent, an organic plan detailing the management of the organic crop, 

livestock, wild harvest, processing, or handling system. The organic plan outlines the 

management practices and inputs that will be used by the operation to comply with organic 

standards. 

1.8 Organic certification is a regulatory system which allows consumers to identify and reward 

operators who meet organic standards. It allows consumers to be confident that organic 

products are produced according to approved management plans in accordance with organic 

standards. Certification requires informed effort on the part of producers and handlers, and 

careful vigilance with consistent, transparent decision making on the part of certifying agents.

1.9 Organic production and handling operations must comply with all applicable local, state, and 

federal laws and address food safety concerns adequately. 

1.10 Organic certification, production, and handling systems serve to educate consumers 

regarding the source, quality, and content of organic foods and products. Product labels must 

be truthful regarding product names, claims, and content. 

1.11 Genetic engineering (recombinant and technology) is a synthetic process designed to 

control nature at the molecular level, with the potential for unforeseen consequences. As 

such, it is not compatible with the principles of organic agriculture (either production or 

handling). Genetically engineered/modified organisms (geo/gmo’sGE/GMOs) and products 

produced by or through the use of genetic engineering are prohibited. 

1.12 Although organic standards prohibit the use of certain materials such as synthetic 

fertilizers, pesticides, and genetically engineered organisms, they cannot ensure that organic 

products are completely free of residues due to background levels in the environment. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 158/302
NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 159/302
2. NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE AGRICULTURE AND 

CONSISTENCY WITH ORGANIC FARMING AND HANDLING 

(NOSB Recommendation Adopted April 29, 2004)

A significant taskresponsibility of the NOSB is to determine the suitability of materials for use in 

organic production and handling. Among the criteria the Board must consider, OFPA requires the 

NOSB to determine the compatibility of a material with organic practices. The following questions 

were developed by the NOSB to assist in determining the compatibility of materials with organic 

practices. 

In order to determine if a substance, its use, and manufacture are compatible with a system of 

sustainable agriculture and consistent with organic farming and handling, and in consideration of 

the NOSB Principles of Organic Production and Handling, the following factors are to be 

considered: 

1. Does the substance promote plant and animal health by enhancing the soil’s physical 

chemical, or biological properties? 

2. Does use of the substance encourage and enhance preventative techniques including cultural 

and biological methods for management of crop, livestock, and/or handling operations? 

3. 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? 

4. Does use of the substance have a positive influence on the health, natural behavior, and 

welfare of livestock? 

5. Does the substance satisfy expectations of organic consumers regarding the authenticity and 

integrity of organic products? 

6. Does the substance allow for an increase in the long-term viability of organic farm operations? 

7. Is there evidence that the substance is mined, manufactured, or produced through reliance on 

child labor or violations of applicable national labor regulations? 

8. If the substance is already on the National List, is the proposed use of the substance 

consistent with other listed uses of the substance? 

9. Is the use of the substance consistent with other substances historically allowed or disallowed 

in organic production and handling? 

10. Would approval of the substance be consistent with international organic regulations 

and guidelines, including Codex? 

11. 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? 

12. Does use of the substance have a positive impact on biodiversity? 

Adopted April 29, 2004 - 13 yes, 0 no, 1 absent 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 160/302
SECTION VIII

 

3. PROCEDURES OF THE NOSB MEMBER DUTIES

To fulfill their responsibilities, Board members agree to adhere to the following Duties. 

Duty of Care 

The Duty of Care calls upon a member to participate in the decisions of the Board and to be 

informed as to the data relevant to such decisions. In essence, the Duty of Care requires that a 

member: 

 Be reasonably informed - It is the duty of all Board members to seek and study the 

information needed to make a reasoned decision and/or recommendation on all business 

brought before the Board. The NOP will provide some of that information, but other 

information must be developed from independent sources. 

 Participate in decisions - Board members are bound by responsibility to be active participants 

in decision making. Absence from a meeting is no protection from the responsibility for 

decisions made at the meeting. 

 Make decisions with the care of an ordinary prudent person in a similar position - The law 

requires Board members to exercise the judgment of an ordinary prudent person who may be 

faced with a similar issue. 

Duty of Loyalty 

The Duty of Loyalty requires Board members to exercise their power in the interest of the organic 

community and the public at large, and not in their own interest or the interest of another entity 

or person. In dispatching their Duty of Loyalty, Board members must: 

 Address conflicts of interest - Board members bring to the NOSB particular areas of expertise 

based upon their personal and business interests in organic production and marketing. 

Because Board members may have interests in conflict with those of the public they must be 

conscious of the potential for such conflicts and act with candor and care. Board members 

must abide by the NOSB conflict of interest policy. 

 Recognize corporate opportunity - Before a Board member votes upon an issue in which they 

have a direct financial interest, that Board member must disclose the transaction to the Board 

in sufficient detail and adequate time to enable the Board to act, or decline to act, in regard to 

such transaction. 

Duty of Obedience 

Board members are bound to obey the tenants of the laws and regulations governing organic 

production, processing and marketing. 

 COMMITTEE WORK PLANS 

At the end of every NOSB meeting, each committee chair is required to present the committee’s 

work plan. Given the nature, and number, of the issues the Board handles, it is important for a 

committee to follow a structured procedure for assigning priorities in the work plan. The following 

provides a guideline on how to develop a committee work plan. The committee chair, working with 

the committee, should follow three general steps in producing a work plan: 1) List all issues before 

the committee; 2) Prioritize each issue; 3) set a calendar; and 4) Obtain feedback from the Executive 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 161/302
Committee and the Program. 

To this effect, Board members must: 

 Act within the requirements of the law - Board members must uphold all state and federal 

statutes, including the Federal Advisory Committee Act (FACA – 5 U.S.C. App. 2 et seq.) 

Adhere to the responsibilities of the Board 

Step 1: Identifying all issues 

The committee work plan rises out of these main situations: 

- Items committed, or assigned to a committee, by the Board during an official session. 

- Items that are reviewed by a committee on a regular basis such as materials sunset review or 

petitions submitted by members of the public. 

- Requests or suggestions from the National Organic Program such as clarifications on a particular 

issue or guidance on enforcement. 

- Proposals stemming from the committee members’ contact with the organic community.

In many cases not all issues should be the responsibility of the committee. Selecting what the 

committee should be reviewing can be done based on the following criteria: 

- Relevance to the organic community (Is this an important issues? vs. Is this an interesting issue?) 

- Criticality regarding mandate (is the issue within the committee’s or the NOSB’s realm?)

- Feasibility in terms of the Rule (can a proposal by the committee be realistically enforced by the 

NOP?) 

Step 2: Prioritizing the issues 

After listing the issues to review, the committee should prioritize its work plan items according to 

the following criteria: 

- Preference given to petitioned materials 

- Relevance to the organic community, public at large and the environment 

- Size of the population affected by the issue 

- Timeline since the issue/petition was submitted 

The criteria are presented in order of importance and should be used to rank or prioritize each issue 

accordingly. For example, a petitioned material has priority over an issue that has been waiting to 

be reviewed for an extended period of time. 

Step 3: Setting a calendar for reviews 

Once the issues are prioritized, the committee chair should define a calendar for discussion of each 

issue. The calendar should allow committee members to understand specific deadlines and should 

reflect the posting/publication target dates mandated by the Program and the Federal Regulation. 

Step 4: Incorporating Input from the Executive Committee 

 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 162/302
The committee chair must present the finalized work plan at the first Executive Committee 

conference call following a normal NOSB meeting. This event is not only an opportunity for the EC 

to provide guidance to the committee chair, but it is also an opportunity to obtain input from the 

NOP regarding the feasibility of implementing the committee’s recommendation. 

 MATERIALS REVIEW PROCESS 

This section presents the procedures followed by the NOSB to evaluate petitions. First, 

the NOP material review process is presented. Second, a review of the NOSB process 

for selecting and reviewing the work of technical advisory panels is provided followed by 

a description needed in a formal petition. Third, the process for NOSB material review 

is provided. This section concludes by providing a graphical description of the sunset 

review process. 

 

Evaluation Procedures for Substances Petitioned for Addition or Removal from the 

National List. A petition to change the annotation to a listed material is in effect the 

addition or removal of one or more materials. 

Definitions: 

Technical Advisory Panel (TAP) - Group of third party experts convened by the Board to 

provide a technical review related to a material petition under review by the NOSB. 

Technical Review – A report prepared by a third party expert under contract addressing the 

environmental, human, and industrial impact of a petitioned material per the OFPA and regulatory 

evaluation criteria to aid in the thorough evaluation of that material by the NOSB. 

Phase 1: Receipt of Petition and Examination of Petition for Completeness and Eligibility 

During this phase the NOP will:

 

 Notify the petitioner via letter and/or electronic mail of receipt of the petition. Determine 

whether the petition is complete 

 Determine if the petitioned substance is eligible for petition under the Organic Foods Production 

Act and its implementing regulations; document this review using the NOP-OFPA checklist. 

 Determine whether the petitioned use is approved under the statutory and regulatory authority 

of the Environmental Protection Agency (EPA); the Food and Drug Administration (FDA); or 

other appropriate federal agency if applicable; 

 Identify and secure any confidential business information (CBI) designated by the petitioner; 

 Notify, as applicable, the petitioner via letter and/or electronic mail of determination of 

completeness and eligibility, and acknowledge the designation of certain information as CBI. 

 Upon determination of completeness and eligibility, the following actions will be taken: 

o PUBLISH THE PETITION ON NOP WEBSITE; AND 

o Notify the National Organic Standards Board (NOSB) materials committee chairperson and 

the chairperson of the committee that the substance is being petitioned for addition or 

prohibition from the National List (Crops, Livestock, Handling or other pertinent 

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committees). This notification will be sent via letter and/or electronic mail and inform the 

chairs that the petition is complete, provide OFPA review and EPA/FDA determination 

checklist, and request identification of any questions the appropriate committee wishes to 

be specifically addressed in the contractor’s report. 

Phase 2: Determine if a Third Party Technical Review is Required 

During this phase: 

 The NOSB materials committee, working with other applicable NOSB committees, 

has 60 days to submit any questions to the NOP. The questions requested by the 

committee should include items that need specific background information, 

recommended technical expertise, and be based on the OFPA criteria. 

 Per the NOP materials review process, the NOSB should review the petition and using the NOP 

checklists for the material determine the following: 

1) If the material is deemed appropriate for consideration on the National List (pending criteria). If the 

answer is no to this question, an explanation is required. 

2) If the answer to question #1 is yes, the NOSB committee assigned for the review (as identified by the 

Materials Committee Chair) must decide if 

a) there is sufficient information in the petition, 

b) the committee can reasonably research any pending technical information, or 

c) there is the need to secure a technical review from a third party expert (see section titled 

Procedures for Handling Technical Reviews) 

3) If the answer to question #1 is no, the Materials Committee Chair will inform the NOP that the 

petition is incomplete and will include an explanation. If the reviewing committee concludes there is 

a need for a third party technical review, the Materials Committee Chair will proceed to make the 

request to the Program. 

 Notify the petitioner, via letter and/or electronic mail, that the petition is incomplete or ineligible; or 

Phase 3: Evaluation by a Third Party Expert 

During this phase the NOP will: 

 Notify the third party expert of the petition’s determination of completeness and 

eligibility. This third party will have technical expertise relevant to the petition and the 

notification will constitute official notice of the need for a technical review. 

During this phase the Third Party Expert will: 

 Conduct activities necessary to provide responses to evaluation questions contained 

in the Statement of Work (SOW) and any additional questions identified by the NOSB 

as described above; 

 Use the TR template to prepare and distribute to the NOP a draft technical report 

(TR) in electronic format. 

Phase 4: Sufficiency Determination 

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During this phase the NOP will: 

 Submit a copy of the draft TR for review to the NOSB materials committee and the 

committee that the substance is being petitioned for addition or prohibition from the 

National List (Crops, Livestock or Handling); 

 Review the draft TR against the following performance criteria. The report will be 

acceptable when it: 

o Is consistent in format, level of detail and tone; 

o IS TECHNICALLY OBJECTIVE AND FREE FROM OPINIONS OR CONJECTURE; 

o Is written in a style appropriate for non-technical readers (e.g. free of technical jargon); 

o Is prepared using a well-defined and consistent procedure consisting of 

information gathering, information synthesis and document preparation, and 

quality assurance; 

o Is based on the best available information that can be obtained within the 

designated time frame; 

o Is thoroughly supported using literature citations; and, 

o Addresses all evaluation questions as set out in the SOW. 

 

During this phase the NOSB materials committee and the committee that the substance 

is being petitioned for addition or prohibition from the National List (Crops, Livestock or 

Handling) will: 

 Review the draft TR against the following performance criteria. The report will be 

acceptable when it: 

o Is consistent in format, level of detail and tone; 

o Is technically objective and free from opinions or conjecture; 

o Is written in a style appropriate for non-technical readers (e.g. free of technical 

jargon); 

o Is prepared using a well-defined and consistent procedure consisting of information 

gathering, information synthesis and document preparation, and quality assurance; 

o Is based on the best available information that can be obtained within the 

designated time frame; 

o Is thoroughly supported using literature citations; and, 

o Addresses all evaluation questions as set out in the SOW. 

 Notify the NOP in letter and/or electronic mail the acceptance of the TR within 60 

days of receiving the TR. If the TR is not accepted by the NOSB materials and the 

committee that the substance is being petitioned for addition or prohibition from the 

National List (Crops, Livestock or Handling), the committees must provide to the NOP in 

letter and/or electronic mail the specific areas of the TR that were concluded to be 

insufficient, the rationale for drawing such a conclusion and the improvements to be 

made so that the document can be determined sufficient. 

 Upon concurrence by the NOP that the TR is insufficient, the NOP will notify the 

contractor by letter and/or electronic mail of the areas of the TR that are insufficient, the 

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rationale for drawing such a conclusion and the improvements to be made so that the 

document can be determined sufficient. The time frame required for the completion of 

the changes will be determined through mutual agreement between the contractor and 

the NOP. 

Phase 5: Action by NOSB Materials Chair and the Committee that the Substance Is Being 

Petitioned for Addition or Prohibition from the National List (Crops, Livestock or 

Handling) 

During this phase the NOSB materials Chair and the committee that the substance is 

being petitioned for addition or prohibition from the National List (Crops, Livestock or 

Handling) will: 

 Convene at a mutually convenient time to review, discuss and recommend an action 

on the petitioned substance. The committee may convene as the TAP by electronic 

mail or conference call to provide complete evaluation of the petitioned substance, as 

provided by OFPA 6518(k)(3). The NOSB materials committee or delegated committee 

must convene and recommend an action on the petitioned substance no later than 60 

days before a scheduled meeting of the full NOSB. 

Phase 6: Action by Full NOSB 

During this phase the NOP will: 

 Publish the recommendation of the NOSB materials committee and the committee 

that the substance is being petitioned for addition or prohibition from the National List 

(Crops, Livestock or Handling) on the NOP website and request a minimum of 60 days 

of written public comment on the recommendation prior to the public NOSB business 

meeting. 

 Set as an agenda item for the next meeting of the NOSB time sufficient to discuss 

and make a recommendation by the full NOSB on the petitioned substance. 

 PROCEDURES FOR HANDLING TECHNICAL REVIEWS 

The NOSB’s role involves reviewing specific materials; however, a petition could involve a wide 

range of topics. Although members of the Board represent several areas of the organic community 

and hold advanced degrees in different scientific areas, they might lack the expertise, or time, 

required to address the data needs of a petition. In such cases the Board has the option of 

requesting the assistance of third party experts and expecting from these experts a written technical 

review or report. 

Third party experts can consist of the following: 

1. Employees of the USDA such as AMS Science & Technology, Agriculture Research Service, or other 

federal agencies with appropriate expertise, as needed. 

2. Consultants or contractors. 

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A committee should follow these steps in deciding the need for third party expert: 

1. Define if the committee has the expertise needed to address the questions related to the petition, 

mainly: 

a. Impact on the environment 

b. Impact to human health 

c. Sustainability and compatibility with organic principles. 

2. If the committee does not have the expertise or resources (e.g., time), the Committee chair should 

make a request to the Chair of the Materials Committee for a third party expert specifying: 

a. The third party expert’s required background and level of expertise

b. Existence of potential sources of conflict that could result in biased reviews. 

3. When requesting the assistance of a third party expert to evaluate a material, a committee must 

identify the main technical issues needed to be addressed including, but no limited to: 

a. All uses of the petitioned material beyond what the petitioner has requested 

b. All uses of the petitioned material in combination with other material(s) that have been already 

approved on the same section of the National List 

c. Interactions of the petitioned material, not addressed by the petitioner, and that may involve 

materials currently on the same section of the National List. 

d. All possible manufacturing methods for a petitioned material. 

e. Potential effects on public health and biodiversity 

f. Environmental risks and hazards including, but not limited to potential for developing pesticide 

resistance, or long-term effects on sustainability 

4. If required, the committee should conduct a final review of the technical report and complete an 

assessment on the quality of work performed by the third party expert. 

These are basic principles that should be considered when dealing with a third party expert: 

1. A committee cannot proceed with a recommendation on a material if it is determined that there is 

limited valid scientific information on that material’s impact on the environment, human health and 

its compatibility with organic principles. 

2. The decision to request third party expert needs to be made independent of the availability of 

funds. If there is a lack of funding to secure third party expert advice, the review of the material 

should be placed on hold. 

3. Although the Board has the final word on the approval or rejection of a petition, the decision to 

request a third party expert is the responsibility of the committee reviewing the material. In some 

cases the Materials Committee can take the initiative to request a third party expert. The logic is 

that a material review is an issue assigned to a committee and it is up to the committee to decide on 

the need for a third party expert. 

4. The decision to define the expertise needed in the third party expert is the responsibility of the 

committee reviewing the material or issue. 

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5. To incorporate a diversity of opinions and to minimize the risk of bias, a committee should aim to 

work with a range of technical experts (individuals, or institutions). 

 HANDLING WITHDRAWALS OF PETITIONS BY THE PETITIONER. 

When a petition involving a material is withdrawn by the petitioner, the Board should suspend its 

review and recommendation procedure. In the case of a petition not involving a material, Board 

members have the option of completing its review and providing a recommendation or guidance. 

In the case a petition previously withdrawn is resubmitted, the Board should review it in the order it 

is received. This means that a withdrawn petition should be considered a completely new request 

and falls to the end of the queue of materials pending review. 

The petitioner can withdraw a petition at any moment during the process of review by the Board, 

public comment, or prior to the Board’s voting on the petition.

A petitioner should have the opportunity to withdraw a petition with the intent of improving it (e.g., 

conducting additional research) only. It is the hope of the Board that petitioners will not abuse this 

privilege with the intent of finding agreeable members in subsequent submissions. 

 TECHNICAL ADVISORY PANEL (TAP) CONTRACT PROCEDURES 

Statement of Work 

Request for Proposals to Perform Technical Advisory Panel Evaluation of Substances Petitioned for 

Inclusion on or Removal from the National Organic Program's National List of Allowed and 

Prohibited Substances. 

 

Agency Need 

See Statement of Work, 1.0 Background.

 

1. Background 

The Organic Foods Production Act of 1990 (OFPA), as amended, requires the Secretary of Agriculture 

(Secretary) to establish a National List of Allowed and Prohibited Substances (National List). This list 

identifies the synthetic substances that may be used, and the nonsynthetic substances that cannot 

be used, by organic production and handling operations. The OFPA authorizes the National Organic 

Standards Board (NOSB) to develop and forward to the Secretary a recommended Proposed 

National List, and subsequent proposed amendments to it. The OFPA provides that persons may 

petition the NOSB to evaluate a substance for inclusion on or removal from the National List 

The NOSB submitted a Proposed National List to the Secretary that was subsequently published on 

December 21, 2000, as part of the National Organic Program (NOP) final rule, 65 Fed. Reg. 80548-

80684, (2000). Based on information supplied to the NOSB by trade associations, certification 

organizations and other organic industry sources, there are many substances currently used in 

organic production and handling that have not been evaluated by the NOSB for inclusion on the 

National List. Evaluations of these substances must be expedited to prevent the possible disruption 

of well-established and accepted production, handling, and processing systems. 

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Section 2119 of the OFPA (7 U.S.C. 6518 (k)(3)) provides that the NOSB shall convene Technical 

Advisory Panels (TAP) to provide scientific evaluation of substances for inclusion on the National 

List. TAP evaluations assist the NOSB in evaluating substances being considered for addition to or 

removal from the National List. The NOP, on behalf of the NOSB, establishes contracts to conduct 

the TAP evaluations. 

 

2. Mission of USDA/AMS/NOP 

 

The mission of NOP is to establish national standards governing the marketing of certain agricultural 

products as organically produced. The NOP is assisted by the NOSB, which provides policy advice in 

carrying out the program, including advising the Secretary on substances for inclusion on or removal 

from the National List. 

The NOSB reviews information from various sources in evaluating substances for 

inclusion on or removal from the National List. Sources include TAP evaluations, the 

Environmental Protection Agency, the Food and Drug Administration, the National 

Institute of Environmental Health Studies, and public comment. The NOSB submits 

its recommendations, along with the results of the required evaluation and technical 

advisory panel evaluation for each substance, to the Secretary for consideration in 

accordance with the requirements of section 2118(d) of the OFPA (7 U.S.C. 

6517(d)). 

 

3. Specific Task 

The contractor(s) shall furnish technical advisory panel evaluations for crop production, livestock 

production, and processing substances submitted to the NOSB in response to petition notices, such 

as was published in the Federal Register on July 13, 2000, as well as other substances requiring 

evaluation as determined by the NOP. 

For crop and livestock production substances, the contractor(s) shall use the criteria in Section 2119 

of the OFPA (7 U.S.C. 6518 (m)(l-7)). The criteria are: 

 The potential of the substance for detrimental chemical interactions with other materials used 

in organic farming systems; 

 The toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence in the environment; 

 The probability of environmental contamination during manufacture, use, misuse or disposal of 

the substance; 

 Its effects on human health; 

 The effects of the substance on biological and chemical interactions in the agroecosystem; 

 The alternatives to using the substance; and, 

 The compatibility of the substance with a system of sustainable agriculture. 

 

For processing substances, the contractor(s) shall use the criteria approved at the 

February 10, 1999, NOSB meeting. The criteria are: 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 169/302
 Processing aid or adjuvant cannot be produced from a natural source and has no organic 

ingredients as substitutes; 

 Manufacture, use, and disposal do not have adverse effects on the environment and are done in 

a manner compatible with organic handling as described in section 6513 of the OFPA; 

 The nutritional quality of the food is maintained and the material itself or its breakdown 

products do not have adverse effects on human health as defined by applicable Federal 

regulations; 

 The primary purpose is not as a preservative or used only to recreate/improve flavors, colors, 

textures, or nutritive value lost during processing, except in the latter case as required by law; 

 It is Generally Recognized as Safe (GRAS) by FDA when used in accordance with Good 

Manufacturing Practices (GMP) and contains no residues of heavy metals or other contaminants 

in excess of FDA tolerances; 

 Its use is compatible with the principles of organic handling; and, 

 There is no other way to produce a similar product without its use and it is used in the minimum 

quantity required to achieve the process. 

 

4. Minimum Skills and Experience Requirements 

 Contractor(s) shall utilize qualified individuals or organizations who have 

specialized knowledge of the petitioned substances. Contractor(s) must have 

demonstrable expertise in organic production and handling or scientific 

disciplines such as veterinary medicine, chemistry, food technology, 

microbiology or toxicology. Contractor(s) must be familiar with the requirement 

for technical advisory panels described inby the Organic Foods Production Act of 1990.

 

5. Place of Performance 

Contractor(s) shall perform all task related activity within the United States of America at specific 

locations determined by contractor(s). During the contract period, the contractor(s) shall travel at 

contractor(s)’s expense to NOSB meetings for the purpose of disseminating substance review 

findings to the NOSB and general public. 

 

6. Government Furnished Equipment and Facility 

None, except that the NOP shall provide Contractor(s), on a non-routine basis, with substance 

review petitions, ancillary documents or other applicable information in possession of NOP. 

 

7. Compensation 

The NOP may award multiple contracts for tasks outlined in this statement of work. Contractor(s) 

shall be compensated at a firm-fixed price rate not to exceed $4,000.00 per substance reviewed. 

Total compensation shall not exceed $100,000.00. 

 

8. Period of Performance 

September 30, 2001 – September 30, 2002 (262 working days)(Holiday time off is at contractor(s)’ 

discretion.) 

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9. Scope of Performance 

Phase 1: Data Gathering and Compilation (120 days) 

Phase I is not to exceed 120 days for any one substance. During this phase the contractor(s) provider 

shall perform the following activities: 

 Characterize [the] substance(s) and identify uses and applications; 

 Determine whether [the] substance(s) are synthetic or non-synthetic (See 7.S.C. 6502 (21) for 

definition of synthetic); 

 Determine [the] substance(s) chemical or biological composition and possible impact on 

human/animal health and the environment; 

 Identify [the] substance(s) relevant toxicological studies, including ensuring substance does not 

contain residues of heavy metals or other environmental contaminants in excess of Food and 

Drug Administration Action Level or Environmental Protection Agency tolerances; 

 Determine [the] substance(s) persistence in the environment; 

 Determine [the] substance(s) effect on soil structure and ecology; 

 Identify alternatives to the use of the substance(s); 

 Determine [the] substance(s) historical use in organic production, processing and handling; and 

 Determine [the] substance(s) status under OFPA and with other government agencies. 

Additionally, within 45 days of commencement of Phase I, the contractor(s) must 

notify the NOP in writing of any substance(s) not appropriate for National List 

evaluation. Other substances for evaluation may be substituted upon agreement 

between the NOP, the NOSB, and the contractor(s). 

 

Phase 2: Evaluation against Criteria (100 days) 

Phase II is not to exceed 100 days for any one substance. The contractor(s) shall engage no less than 

three evaluators for each substance. No current member of the NOSB may serve as an evaluator. 

Evaluators may use data from all relevant sources. Evaluators shall make recommendations to the 

contractor(s) as to the substance’s status as synthetic or non-synthetic and whether, in either case, 

the substance should be added to or removed from the National List. 

 

Phase 3: Recommendation (42 days) 

Phase III is not to exceed 42 days for any one substance. Contractor(s) shall provide the NOP with a 

recommendation regarding each substance's suitability for inclusion on or removal from the 

National List. All data and analyses collected in Phase I and II will be forwarded to the NOP upon the 

completion of Phase III in accordance with the reporting requirements stated below. 

 

Evaluation Factors for Award 

The NOP may award multiple contracts for tasks outlined in this statement of work. Contractor(s) 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 171/302
selection will be based on evaluation of proposals in accordance with the responses received to the 

criteria outlined in Section 4.0, Minimum Skills and Experience Requirements and Section 9.0, Scope 

of Tasks. Award will be made to that offeror whose combination of technical experience and cost 

represents the best value to the Government and is most advantageous (cost, and other factors 

considered), and which is within the available NOP resources. 

The NOP also reserves the right to reject any or all proposals received and/or request clarification or 

modification of proposals. The NOP reserves the right to determine a competitive range for 

negotiation based upon the technical and cost acceptability of proposals. In addition, the NOP 

reserves the right to award a contract without discussions. 

Cost evaluation will include an analysis of the total cost and cost elements (if applicable) to perform 

the required work. The total costs supplied by the offeror shall constitute the total firm-fixed unit 

price for that service or deliverable. 

Proposals that are unrealistic in terms of technical commitment, or unreasonably low or high in 

costs, will be deemed reflective of an inherent lack of technical competence or as indicative of a 

failure to comprehend the complexity involved in the contract requirements. Such may be grounds 

for rejection of the proposal. 

 

Other Evaluation Factors 

Technical proposals will be initially evaluated with respect to six (6) major factors for determination 

of the competitive range. Technical factors are listed in descending order of importance. The 

technical proposal is of greater importance than the cost proposal; when technical proposals are 

relatively equal in technical merit, cost will increase in importance. 

Technical Factors: 

Factor 1 Overall Technical Approach; Proposed Methodology; Demonstrated Understanding of the 

Scope of Work and the Requirements 

Factor 2 Previous Demonstrated Experience and Past Performance 

Factor 3 Quality Control 

Factor 4 Capability and Experience of Key Personnel 

Factor 5 Project Management and Support Capability 

Factor 6 Reasonableness of Cost 

 

 

 

Reporting Requirements 

Progress reports are due to the NOP each 60 days after the contract award date. A final report is 

due within 60 days of the end of the contract period. The contractor(s) shall forward five copies of 

the bi-monthly progress reports and the final report and all deliverables to the NOP in Washington 

DC. Documents should be addressed to: Richard H. Mathews, Program Manager, National Organic 

Program, USDA-AMS-TM-NOP, 1400 Independence Avenue, S.W., Room 4008-So., Ag Stop 0268, 

Washington, D.C. 20250-0200, Attention: Substance Evaluations. 

The narrative in the progress reports should refer back to the stated objectives and timeline of the 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 172/302
original contract proposal. Beneath each objective, the objective's current status should be 

reported. Any substantive diversion from a stated objective, or any deviation from the proposed 

timeline should be explained. Only the activities required under the contract should be reported. At 

a minimum, the progress reports should also include the following: 

1. A short summary of the accomplishments for the reporting period; 

2. Progress on completing individual project tasks; 

3. The planned and actual schedules for task completion; 

4. Projected accomplishments for the next reporting period; and, 

5. Data on financial expenditures by task category. 

Any deliverables required under the contract should be submitted upon completion and addressed 

to: NOP Program Director, National Organic Program, USDA-AMS-TM-NOP, 1400 Independence 

Avenue, S.W., Room 4004-So., Ag Stop 0268, Washington, D.C. 20250-0268, Attention: Substance 

Evaluations. 

INFORMATION TO BE INCLUDED IN A PETITION 

 

Any person may petition to add a substance to or remove a substance from the National List of 

Allowed and prohibited Substances by submitting the information and following the procedures 

identified below. 

ITEM A 

The petitioner should identify which of the following categories the substance is being petitioned for 

inclusion on or removal from the National List: 

1. Synthetic substance's allowed for use in organic crop production; 

2. Nonsynthetic substances prohibited for use in organic crop production; 

3. Synthetic substances allowed for use in organic livestock production; 

4. Nonsynthetic substances prohibited for use in organic livestock production; 

5. Nonagricultural (nonorganic) substances allowed in or on processed products labeled as 

“organic'' or “made with organic (specified ingredients)'; or 

6. Nonorganic agricultural substances not commercially available in organic form. 

ITEM B 

The petitioner must submit the following information: 

1. The substance’s common name. 

2. The manufacturer’s name, address, and telephone number. 

3. The intended or current use of the substance such as use as a pesticide, animal feed additive, 

processing aid, nonagricultural ingredient, sanitizer, or disinfectant. 

4. A list of the crop, livestock, or handling activities for which the substance will be used. If used for 

crops or livestock, the substance's rate and method of application must be described. If used for 

handling (including processing), the substance’s mode of action must be described. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 173/302
5. The source of the substance and a detailed description of its manufacturing or processing 

procedures from the basic component(s) to the final product. Petitioners with concerns for 

confidential business information can follow the guidelines in the Instructions for Submitting 

Confidential Business Information (CBI) listed in #13. 

6. A summary of any available previous reviews by State or private certification programs or other 

organizations of the petitioned substance. 

7. Information regarding EPA, FDA, and State regulatory authority registrations, including registration 

numbers. 

8. The Chemical Abstract Service (CAS) number or other product numbers of the substance and labels 

of products that contains the petitioned substance. 

9. The substance's physical properties and chemical mode of action including (a) chemical interactions 

with other substances, especially substances used in organic production; (b) toxicity and 

environmental persistence; (c) environmental impacts from its use or manufacture; (d) effects on 

human health; and, (e) effects on soil organisms, crops, or livestock. 

10. Safety information about the substance including a Material Safety Data Sheet (MSDS) and a 

substance report from the National Institute of Environmental Health Studies. 

11. Research information about the substance which includes comprehensive substance research 

reviews and research bibliographies, including reviews and bibliographies which present contrasting 

positions to those presented by the petitioner in supporting the substance's inclusion on or removal 

from the National List. 

 

12. A “Petition Justification Statement'' which provides justification for one of the following actions 

requested in the petition: 

 

A. Inclusion of a Synthetic on the National List, §§ 205.601, 205.603, 

205.605(b) 

• Explain why the synthetic substance is necessary for the production or handling 

of an organic product. 

• Describe any non-synthetic substances, synthetic substances on the National 

List or alternative cultural 

methods that could be used in place of the petitioned synthetic substance. 

• Describe the beneficial effects to the environment, human health, or farm 

ecosystem from use of the synthetic substance that support its use instead of the 

use of a non-synthetic substance or alternative cultural methods. 

B. Removal of a Synthetic From the National List, §§ 205.601, 205.603, 205.605(b) 

• Explain why the synthetic substance is no longer necessary or appropriate for 

the production or handling of an organic product. 

• Describe any non-synthetic substances, synthetic substances on the National 

List or alternative cultural methods that could be used in place of the petitioned 

synthetic substance. 

C. Inclusion of a Prohibition of a Non-Synthetic, §§ 205.602 and 205.604 

• Explain why the non-synthetic substance should not be permitted in the 

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production of an organic product. 

• Describe other non-synthetic substances or synthetic substances on the 

National List or alternative cultural methods that could be used in place of the 

petitioned substance. 

D. Removal of a Prohibited Non-Synthetic From the National List, §§ 205.602 and 

205.604 

• Explain why the non-synthetic substance should be permitted in the production 

of an organic product. 

• Describe the beneficial effects to the environment, human health, or farm 

ecosystem from use of the non-synthetic substance that supports its use instead 

of the use of other non-synthetic or synthetic substances on the National List or 

alternative cultural methods. 

E. Inclusion of a Non-Synthetic, Non-Agricultural Substance Onto the National List, § 

205.605(a) 

• Explain why the substance is necessary for use in organic handling. 

• Describe non-synthetic or synthetic substances on the National List or 

alternative cultural methods that could be used in place of the petitioned 

synthetic substance. 

• Describe any beneficial effects on the environment, or human health from the 

use of the substance that support its use instead of the use of non-synthetic or 

synthetic substances on the National List or alternative cultural methods. 

F. Removal of a Non-Synthetic, Non-Agricultural Substance From the National List, 

§ 205.605(a) 

• Explain why the substance is no longer necessary for use in organic handling. 

• Describe any non-synthetic or synthetic substances on the National List or 

alternative cultural methods that could be used in place of the petitioned 

substance. 

G. Inclusion of a Non-Organically Produced Agricultural Substance Onto the 

National List, § 205.606 

• Provide a comparative description on why the non-organic form of the 

substance is necessary for use in organic handling. 

• Provide current and historical industry information/research/evidence that 

explains how or why the substance cannot be obtained organically in the 

appropriate form, appropriate quality, and appropriate quantity to fulfill an 

essential function in a system of organic handling. 

• Describe industry information on substance non-availability of organic sources 

including but not limited to the following guidance regarding commercial 

availability evaluation criteria: 

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(1) Regions of production, including factors such as climate and number 

of regions; 

(2) Number of suppliers and amount produced; 

(3) Current and historical supplies related to weather events such as 

hurricanes, floods, and droughts that may temporarily halt production or 

destroy crops or supplies; 

(4) Trade related issues such as evidence of hoarding, war, trade 

barriers, or civil unrest that may temporarily restrict supplies, and 

(5) Other issues which may present a challenge to a consistent supply. 

H. Removal of a Non-Organically Produced Agricultural Substance From the 

National List, § 205.606 

• Provide a comparative description as to why the non-organic form of the 

substance is not necessary for use in organic handling. 

• Provide current and historical industry information/research/evidence that 

explains how or why the substance can be obtained organically in the 

appropriate form, appropriate quality, and appropriate quantity to fulfill an 

essential function in a system of organic handling. 

• Provide new industry information on substance availability of organic sources 

including but not limited to the following guidance commercial availability 

evaluation criteria: 

(1) Region of production, including factors such as climate and number of 

regions; 

(2) Number of suppliers and amount produced; 

(3) Current and historical supplies related to weather events such as 

hurricanes, floods, or droughts that temporarily halt production or destroy 

crops or supplies; 

(4) Trade related issues such as evidence of hoarding, war, trade 

barriers, and civil unrest that may temporarily restrict supplies and; 

(5) Any other issues which may present a challenge to a consistent 

supply. 

13. A Commercial Confidential Information Statement which describes the specific required information 

contained in the petition that is considered to be Confidential Business Information (CBI) or 

confidential commercial information and the basis for that determination. Petitioners should limit 

their submission of confidential information to that needed to address the areas for which this 

notice requests information. Instructions for submitting CBI to the National List Petition process are 

presented in the instructions below: 

a. Financial or commercial information the applicant does not want disclosed for competitive 

reasons can be claimed as CBI. Applicants must submit a written justification to support 

each claim. 

b. “Trade secrets'' (information relating to the production process, such as formulas, 

processes, quality control tests and data, and research methodology) may be claimed as CBI. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 176/302
This information must be 

(1) commercially valuable, 

(2) used in the applicant's business, and 

(3) maintained in secrecy. 

c. Each page containing CBI material must have “CBI Copy'' marked in the upper right corner of 

the page. In the right margin, mark the CBI information with a bracket and “CBI.'' 

d. The CBI-deleted copy should be a facsimile of the CBI copy, except for spaces occurring in 

the text where CBI has been deleted. Be sure that the CBI-deleted copy is paginated the 

same as the CBI copy. (The CBI-deleted copy of the application should be made from the 

same copy of the application which originally contained CBI.) Additional material 

(transitions, paraphrasing, or generic substitutions, etc.) should not be included in the CBIdeleted copy. 

e. Each page with CBI-deletions should be marked “CBI-deleted'' at the upper right corner of 

the page. In the right margin, mark the place where the CBI material has been deleted with 

a bracket and “CBI- deleted.'' 

f. If several pages are CBI-deleted, a single page designating the numbers of deleted pages 

may be substituted for blank pages. (For example, “pages 7 through 10 have been CBIdeleted.'') 

g. All published references that appear in the CBI copy should be included in the reference list 

of the CBI-deleted copy. Published information usually cannot be claimed as confidential. 

National List substance evaluations conducted by the NOSB will involve a public and open process. 

No confidential information will be available for public inspection. 

The NOP Program Director may request additional information from the petitioner following receipt 

of the petition. 

 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 177/302
 PRIORITY OF PETITIONS GUIDELINE 

Prioritization 

National List materials petitions received and deemed sufficient by the NOP / NOSB will be 

prioritized by the Materials Committee Chair for consideration as follows:

1. Petitions to Remove a Material From the National List:

a. A petition to remove a material presently on the National list that raises serious health, 

environmental, or regulatory concerns, including petitions to reconsider previous 

decisions, will be given the highest priority - Priority 1, above all other petitions in the 

queue of the reviewing committee (Crops, Handling, or Livestock). 

b. A petition to remove a material presently on the National list not 

based on serious health, environmental, or regulatory concerns, but based 

on other new information, such as commercial availability status, would be 

assigned a Priority 2, behind Priority 1 petitions, but above any petitions 

to list materials that are in the queue of the reviewing committee (Crops, 

Handling, or Livestock). This priority assignment would include any 

removal petitions requesting reconsideration of previous board decisions, 

if the resubmitted petition contains substantive new information to warrant 

reconsideration. 

2. Petitions to Add a MaterialAdhere to the National List: 

a. A petition to add a material to the National List will be considered by the reviewing 

committee (Crops, Handling, or Livestock) requirements specified in the chronological 

order it is received, and will be designated as Priority 3. 

3. Petitions to Reconsider a Material for Addition to the National List: 

a. A petition to reconsider adding a material that had previously been rejected by a board 

vote would be given the lowest priority - Priority 4, and would go to the bottom of the 

committee (Crops, Handling, or Livestock) queue of petitioned materials. Petitions for 

listing a substance that had been previously rejected by the board must contain 

substantive new information to warrant reconsideration. 

This prioritization guideline is only that, a guideline. When situations occur beyond the control of 

the reviewing committee, such as, but not limited to, a delay in the delivery of a Technical Review 

for a petitioned substance, the committee chair must exercise his or her judgment in the possible 

reassignment of priorities and workload to make best use of resources to advance petition 

recommendations. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 178/302
 NOSB COMMITTEE RECOMMENDATIONPolicy and Procedures Manual

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: ______________________________ Substance: ___________________________

Committee: Crops  Livestock  Handling  Petition is for:_____________________________________________

___________________________________________________ on the National List § 205._________________________

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes  No  N/A 

2. Essential & Availability Criteria Yes  No  N/A 

3. Compatibility & Consistency Yes  No  N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A  

B. Substance Fails Criteria Category: _________ Comments: ___________________________________________________ 

___________________________________________________________________________________________________

C. Proposed Annotation (if any): _________________________________________________________________________ 

____________________________________________________________________________________________________

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:____________________

D. Recommended Committee Action & Vote, including classification recommendation (State Actual Motion): 

_________________________________________________________________________________________________

Classification of the material: Synthetic ________ Non- synthetic_____________ Absent:_________ Abstain _________ 

Motion by: _______________ Seconded:________________ Yes: _____ No: _____ Absent: _______ Abstain: _____

Recommended Committee Action & Vote _____________________________________________________________

____________________________________________________________________________________________________

 

Motion by: _______________ Seconded:________________ Yes: _____ No: _____ Absent: _______ Abstain: _____

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) ____________________

____________________________________________________________________________________________________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _______________________

____________________________________________________________________________________________________

Describe why a prohibited substance:_______________________________________________________________________

____________________________________________________________________________________________________

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

____________________________________________________________________________________________________

4) Substance was recommended to be deferred because _________________________________________________________

____________________________________________________________________________________________________ 

If follow-up needed, who will follow up _____________________________________________________________________

Crops Agricultural Allowed1 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic Rejected3

No 

restriction 

Commercially UnAvailable as 

Organic1 

Deferred4

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 179/302
E. Approved by Committee Chair to transmit to NOSB:

______________________________________ _________________________

 Committee Chair Date

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 180/302
EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL 

LIST

 

Category 1. Adverse impacts on humans or the environment? Substance ____________ 

 

Question Yes No N/A

1 Documentation

(TAP; petition; regulatory agency; 

other)

1. Are there adverse effects on 

environment from manufacture, use, 

or disposal? [§205.600 b.2] 

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3] 

3. Is the substance harmful to the 

environment and biodiversity? 

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

4. Does the substance contain List 1, 2, or 3 

inerts? [§6517 c (1 ) (B)(ii); 

205.601(m)2] 

5. Is there potential for detrimental 

chemical interaction with other 

materials used? 

[§6518 m.1] 

6. Are there adverse biological and chemical 

interactions in agro- ecosystem? [§6518 

m.5] 

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5] 

8. Is there a toxic or other adverse action of 

the material or its breakdown 

products? 

[§6518 m.2] 

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment?[§6518 m.2] 

10. Is there any harmful effect on human 

health? [§6517 c (1)(A) (i) ; 6517 

c(2)(A)I; §6518 m.4] 

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3] 

12. Is the substance GRAS when used 

according to FDA’s good manufacturing 

practices? [§205.600 b.5] 

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

b.5] 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 181/302
1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 182/302
Category 2. Is the Substance Essential for Organic Production? Substance ___________ 

 

Question Yes No N/A

1

Documentation

(TAP; petition; regulatory agency; other)

1. Is there a natural source of 

the substance? 

[§205.600 b.1] 

2. Is there an organic 

substitute? [§205.600 b.1] 

3. Is the substance essential 

for handling of organically 

produced agricultural 

products? [§205.600 b.6] 

4. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)] 

5. Is the substance used in 

handling, not synthetic, but 

not organically produced? 

[§6517 c (1)(B)(iii)] 

6. Is there any alternative 

substances? [§6518 m.6] 

7. Is there another practice 

that would make the 

substance unnecessary? 

[§6518 m.6] 

8. Is the substance used in 

handling, not synthetic, but 

not organically produced? 

[§6517 c (1)(B)(iii)]

9. Is there any alternative 

substances? [§6518 m.6]

10. Is there another practice 

that would make the 

substance unnecessary? 

[§6518 m.6]

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b)are N/A—not applicable. 

 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 183/302
Category 3. Is the substance compatible with organic production practices? 

Substance ____________________

 

Question Yes No N/A

1 Documentation

(TAP; petition; regulatory agency; 

other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2] 

2. Is the substance consistent with 

organic farming and handling, and 

biodiversity? [§6517 c (1)(A)(iii); 

6517 c (2)(A)(ii)] 

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7] 

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3] 

5. Is the primary use as a 

preservative? [§205.600 b.4] 

6. Is the primary use to recreate or 

improve flavors, colors, textures, or 

nutritive values lost in processing 

(except when required by law, e.g., 

vitamin D in milk)? [205.600 b.4] 

7. Is the substance used in production, 

and does it contain an active 

synthetic ingredient in the following 

categories: 

a. copper and sulfur compounds; 

b. toxins derived from bacteria; 

c. pheromones, soaps, horticultural 

oils, fish emulsions, treated seed, 

vitamins and minerals? 

d. livestock parasiticides and 

medicines? 

e. production aids including netting, 

tree wraps and seals, insect traps, 

sticky barriers, row covers, and 

equipment cleaners? 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 184/302
Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance ____________________

Question Yes No N/A

1 Documentation

(TAP; petition; regulatory agency; 

other)

1. Is the comparative description 

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic 

handling? 

2. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the 

material /substance cannot be obtained 

organically in the appropriate form to 

fulfill an essential function in a system 

of organic handling? 

3. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the 

material /substance cannot be obtained 

organically in the appropriate quality to 

fulfill an essential function in a system 

of organic handling? 

4. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the 

material /substance cannot be obtained 

organically in the appropriate quantity

to fulfill an essential function in a 

system of organic handling?

5. Does the industry information provided 

on material / substance non-availability 

as organic, include ( but not limited to) 

the following:

a. Regions of production (including factors 

such as climate and number of regions);

b. Number of suppliers and amount 

produced;

c. Current and historical supplies related 

to weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

e. Are there other issues which may 

present a challenge to a consistent 

supply?

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 185/302
 NOSB RECOMMENDED DECISION FORM 

Form NOPLIST2. Full Board Transmittal to NOP 

 

For NOSB Meeting: _____________________ Substance: ___________________________ 

A. Evaluation Criteria (Documentation attached; committee recommendation attached) 

 Criteria Satisfied? 

1. Impact on humans and environment Yes No (see B below) 

2. Availability criteria Yes No (see B below)

3. Compatibility & consistency Yes No (see B below) 

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

C. Proposed Annotation: ______________________________________ 

___________________________________________________________ 

Basis for annotation: 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________ 

. Final Board Action & Vote: Motion by: ____________________ Second:____________________________ 

 

Vote: 

 

 Yes: _____ 

 

 No: _____ 

 Abstain: _____ 

 

 

1) Substance voted to be added as “allowed” on National List 

Annotation: ______________________________________________________ ___________ 

2) Substance to be added to “prohibited” paragraph of National List 

Describe why a prohibited substance:______________________________________________________________________________ 

 

3) Substance was rejected by vote for amending National List 

Describe why material was rejected:____________ __________________________________________________________ ____ 

 

4) Substance was recommended to be deferred 

Describe why deferred; if any follow-up is needed. If follow-up needed, who conducts follow-up _________________________ ___ 

 . 

Agricultural Nonagricultural Crops 

Synthetic Not synthetic Livestock 

Allowed

1

Prohibited

2

Handling 

No restriction Deferred4 Rejected

3 

E. Approved by NOSB Chair to transmit to NOP: 

______________________________________ _________________________ 

 , NOSB Chair Date 

F. NOP Action: Include in FR to amend National List: 

 Return to NOSB Reason: ____________________________________________________________________ 

_____________________________________ _________________________ 

 , NOP Director Date 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 186/302
 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 187/302
 PROCEDURES FOR THE MATERIALS REVIEW PROCESS FOR NOSB 

MEMBERS 

 

1. Upon receipt of the TAP reviews each member should read the report prepared by the contractor, 

along with the submitted petition, additional information and recommendations of the contracted 

panel of experts. 

2. Questions or clarification of the review may be answered by further review of the literature 

provided by the TAP contractor or by the Chair of the committee contacting the contractor directly. 

Questions regarding the process can be directed to the Chair of the Materials Committee. 

3. The materials are either directed to the processing, crops or livestock committee(s) depending on 

the specified use(s) of the material as stated in the petition. NOSB members assigned to those 

committees shall conduct a thorough review of the material and vote on whether it is synthetic or 

nonsynthetic, and then if it should be allowed or prohibited for specific use as either a crop, 

livestock or processing material. Materials may be followed by an annotation which restricts their 

use. Recommended annotations applicable to the material must be voted on by committee. 

4. Committee draft recommendations will be submitted to the NOP at least thirty (30) days prior to the 

next NOSB meeting where the material will be considered. 

5. The Chair of each committee will present the Board with the committee’s written votes and 

recommendations during the Materials Review process at the NOSB meeting. The recommendation 

should come in the form of a motion which must be seconded by an NOSB member to move 

forward. The process will follow Robert’s Rules of Order in which the Chair would open the motion 

for discussion. The Chair shall ask if any Board members have conflicts of interest. After discussion 

board members will vote on the motion. 

6. NOP staff will record the votes of the each NOSB member and announce whether or not the motion 

passed. 

7. If the motion fails the Board Chair asks for a new motion and the procedure is repeated until a final 

motion is passed by a 2/3 majority. 

 SUNSET REVIEW PROCESS 

Sunset is a regulatory process for determining the continued listing of a material already 

approved or prohibited on the National List for use in organic agriculture production and 

handling. It is not used to petition to add a new substance (nor is it used to change an 

existing annotation) or new uses of a listed substance. If the review and renewal 

process is not concluded by the expiration date, the use of the material will become 

prohibited. (Since sunset is defined as the reviewing of regulations to ensure the 

continued relevance and not the creation of new regulation, all substance must be 

renewed as listed. If there is a need to consider changing an annotation or moving a 

material from one list to another, this may be accomplished through the existing 

procedures for petition.) 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 188/302
Since the sunset review process is an assessment of National List substances to 

ensure their continued compliance with regulatory standards, the NOSB may determine 

that new restrictions in the form of annotations are necessary given changes in use 

patterns and scientific understanding. An annotation to expand the use of a substance 

does not fall within the purview of the sunset process and must only be considered 

through the petition process. 

The Organic Foods Production Act of 1990 (OFPA) authorized a National 

List of Allowed and Prohibited Substances (Section 6517). Sections 6517 (e) 

mandates a Sunset Provision as follows: 

“No exception or prohibition in the National list shall be valid unless the National Organic Standards 

Board has reviewed such exemption or prohibition as provided in this section within 5 years of such 

exemption or prohibition being adopted and the Secretary has reviewed such exemption or 

prohibition.”

The National List that was implemented in October 21, 2002 contained over 200 substances. The 

first sunset review of listed materials was completed in October, 2007. Decisions made through the 

Sunset review must be transparent, non-arbitrary, based on the best current information and in the 

interest of the organic community and public at large. 

Steps followed in Sunset Process 

Not all listed materials reach sunset status at the same time, but the review process includes these 

steps: 

1. A public notice is placed in the Federal register (Advance Notice of Proposed Rule Making or ANPR 

of the pending sunset of the listed materials. The public has 60 days after the publication date to 

provide written comment (see Chart 1 below). The committee may request a third party technical 

review in anticipation of scientific evidence and claims likely to be made during public comment to 

the ANPR. 

2. Public comments are collected and forward to the NOSB (see Chart 2). 

3. The appropriate NOSB committee begins review of the material with the intent of providing a 

recommendation to the entire Board for the material’s removal, renewal, or renewal with the 

addition of an annotation. The review is conducted based on “Force of Evidence” as presented by 

Board members, public comments, and scientific data from other sources (see Chart 3). This includes 

the original recommendation from the Board to list. The committee may request a third party 

technical review, if needed, to verify scientific evidence and claims made during public comment to 

the ANPR. 

4. The reviewing NOSB committee provides its recommendation to the full Board and the public no 

less than 60 days prior to the Board Meeting which would include the following: 

(i). Simple motion to remove, add, or amend an annotation, resulting in the restriction or 

clarification of the use of a material (if applicable). 

(ii). Simple motion to renew the existing listing. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 189/302
Committee Recommendations Posted on 

NOP Website

60 days prior to NOSB meeting

Additional Public Comments Received

NOSB Final Vote

NOP Receives Public Comments

Committee Reviews Evidence for Delisting

(See chart 3 for detail)

Complete Material Review Forms

NOSB Notified of Comments

(within 5 days of NOP receipt)

Notification to Materials Chair

Notification to Committee Chair

Comments Posted on NOP Website

(within 5 days of NOP receipt)

Posted by Category

Handling (H), Crops (C), Livestock (L)

Additional Comments Received

On Posted Materials

NOSB Notified of Additional Comments

5. At the public NOSB business meeting, the NOSB hears additional public comment, discusses the 

force of evidence, and votes on the committee’s recommendation.

6. The NOP reviews the NOSB recommendation and accompanying documentation and publishes a 

proposed rule to review the National List. The public has 90 days after the publication date to 

comment. All comments are made available on the NOP website. 

The NOP will review public comment and draft the final rule. The final rule will proceed through 

interagency (i.e. OGC , OMB, and departmental) and congressional review, and upon receiving 

clearance from the appropriate parties, the NOP will publish the final rule in the Federal 

Register. The final rule process is illustrated in Chart 4. 

Chart 1: Sunset Review – NOP Posts an ANPR 

Chart 2: Sunset Review – NOP Collects and Forwards Public Comment to the NOSB 

NOP Develops Regulatory review work plan and drafts Advanced Notice of Public Rulemaking

(60 days)

OGC Review and Departmental Clearance

(60 days)

NOP publishes a FR notice for an Advanced Notice of Public Rulemaking

(Allow 60 days for public comment)

NOP receives comments, forwards to NOSB, and posts to the NOP Website

(All comments shall be in NOSB possession no later than 7 days after the closing date of public comment)

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 190/302
Chart 3: Sunset Review – NOSB Committee Reviews Evidence for Delisting 

NOSB submits 

recommendation 

to remove material

Does NOSB 

committee have 

evidence for 

removal? Yes

No

No NOP provides public announcement Yes

Yes

Evidence for 

removal from the 

Public Input?

NOSB submits 

recommendation to 

continue listing material

NOSB Committee Receives Request to 

Review Sunset Material – plus copies of public input

Is a Technical 

Review needed to 

make decision? No Form a 

Technical 

Advisory Panel (TAP)

TAP completes 

technical review 

and submits 

findings to 

NOSB 

committee

 

 

NOP Drafts Final Rule

(90 days)

OGC Review

(90 days)

Interagency Review

(90 days)

OMB Review

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 191/302
HANDLING TECHNICAL ERRORS AFTER AN ITEM HAS BEEN PLACED IN 

THE FEDERAL REGISTER 

 

In order to minimize confusion in the organic community, the Board needs to monitor and correct 

discrepancies between items which have been voted on and their subsequent insertion in the 

Federal Register. Some examples of the different types of technical corrections needed are: 

Annotations different than what was originally recommended by NOSB and changed by the Program 

in order to fit the demands of other federal regulatory bodies (ex: livestock medications withholding 

times). 

An unforeseen consequence of a recommendation voted by the Board could require additional 

annotations in order to fit the needs of the organic industry. The absence, for example, of an 

explicit description of what methods of extraction are allowed for specific materials could result in 

the unwanted use of materials extracted using prohibited extraction processes. 

The Board should follow these steps to monitor and correct technical discrepancies: 

(1) The Secretary of the Board, with the assistance of the NOSB Executive Director, shall review all 

additions to the Federal Register and report to the Board any discrepancies between Board 

recommendation and those published in the Federal Register. 

(2) When the Program incorporates changes to a recommendation voted and presented by the 

Board, the Program is expected to communicate these changes prior to final action by the Program 

to the Board Chair, Vice Chair and Secretary. The Board Chair, Vice Chair and Secretary will report 

such activity to the Board and then work with the Program in order to assist the Program in stating 

the exact reasons for such deviations in the preamble to the Rule change posted. 

(3) In the cases of unintended consequences with a published recommendation, the Chair of the 

Board, with the approval of the Executive Committee, will assign committee to resolve the issue. 

 

APPENDICES AND RESOURCES 

Appendix A - DECISION MAKING PROCEDURES FOR THE NOP 

1. Define the Problem 

a. What is the problem? 

b. Identify where we are now. 

i. State the present condition in no more than two sentences. 

c. Identify where we want to be. 

i. State the future objective in no more than two sentences. 

2. Analyze the Problem 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 192/302
a. Why is there a problem? 

b. Is the evidence of the problem supported by credible and compelling facts or data? 

i. What are the facts or data used to draw an affirmative conclusion? 

c. Who does this problem affect? 

d. What is the problem's effect? 

e. In what time frame must the problem be resolved? 

f. If the problem deserves immediate attention, what other priorities must be adjusted to 

accommodate this problem? 

g. If the problem deserves immediate attention, what are the consequences of a delay? 

3. Develop Possible Solutions 

a. Propose ideas for possible solutions 

b. Evaluate ideas for possible solutions 

i. List pros for each possible solution 

ii. List cons for each possible solution 

c. Select a Solution 

i. Is the recommended solution legal? 

ii. Is the recommended solution practical? 

iii. Is the recommended solution supported by credible and compelling facts or data? 

1. What are the facts or data used to draw an affirmative conclusion? 

iv. How does the recommended solution solve the problem? 

v. How does the recommended solution meet the time frame identified in 2(b)? 

d. Review recommended solution for unintended consequences. 

4. Develop Action Plan 

a. Develop Action Steps 

i. Identify action steps to bridge the gap between present condition and future objective 

using the recommended solution. 

b. Approve Action Plan 

c. Implement Action Plan 

 Final – 5/9/2003 

B. Appendix B -2 – FACA FACTS 

 

The Federal Advisory Committee Act (FACA) (5 U.S.C. App.2) and its implementing regulations 

(41 CFR Part 101-6.10) govern the creation, operation, and termination of advisory committees 

in the Executive Branch of the Federal Government. The National Organic Standards Board 

(NOSB) is a Department of Agriculture (USDA) non-discretionary advisory committee required by 

the Organic Foods Production Act of 1990, as amended. 

 Advisory committees must be chartered before they can meet or conduct any business. 

Charters must be renewed every two years or they will be terminated under the sunset 

provisions of Section 14 of the FACA, unless otherwise provided by law. 

 Advisory committee meetings are required to be open to the public, with limited exceptions 

as provided for in Section 552b of title 5, United States Code. Meetings not subject to FACA 

include NOSB briefing meetings initiated by the USDA to exchange facts and information, 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 193/302
such as member orientation and training, and NOSB committeeSubcommittee meetings. 

Such meetings are not subject to FACA because they are not conducted for the purpose of 

providing the USDA with NOSB advice or recommendations. 

 Designated Federal OfficialsOfficers must approve all meetings and agendas, and attend 

meetings. The NOP Program DirectorAdvisory Board Specialist is the NOSB’s Designated 

Federal OfficialOfficer. 

 Meeting notices and agendas must be published in the Federal Register to accommodate 

public participation. Although not required by FACA, the NOP strives to: 

o Post a provisional agenda, on its web site, no later than 90 days before the meeting is 

scheduled to begin,

o Post a final agenda, on its web site, no later than 45 days before the meeting is scheduled 

to begin, and 

o Publish notice of the meeting in the Federal Register no later than 45 days before the 

meeting is scheduled to begin.

 Detailed minutes will be kept and must contain: 

a. Date and location of the meeting, 

b. A record of the persons present, 

c. A complete and accurate description of matters discussed and conclusions 

reached, and 

d. Any advice or recommendations provided by the committee. 

 While meeting transcripts are not required under FACA, the NOP provides transcripts or 

meeting notes to support the transparency of Board meetings and to support subsequent 

rulemaking activities. The NOP also issues a short meeting summary, which is required by 

FACA, after each biannual meeting that summarizes the key issues discussed, and the 

outcome of voting. 

 Advisory committee documents must be available for public inspection and copying until the 

committee ceases to exist. 

 Interested persons shall be permitted to attend, appear before, or file statements with any 

advisory committee, subject to reasonable rules or regulations. 

 Additional information may be found at the FACA homepage: 

http://www.gsa.gov/Portal/gsa/ep/channelView.do?pageTypeId=8203&channel

Page=/ep/channel/gsaOverview.jsp&channelId=-

13170http://www.gsa.gov/portal/content/100916

 Appendix C - DUTIES OF THE DESIGNATED FEDERAL OFFICER 

 

The Designated Federal Officer assigned to the National Organic Standards Board and its 

committees, under the Federal Advisory Committee Act (U.S.C. App.2) and its implementing 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 194/302
regulations (41 CFR Part 101-6.10), is the National Organic Program’s Program Director. The 

Program Director: 

 

1. Must approve or call the meeting of the NOSB; 

2. Must approve the agenda; 

3. Must attend the meetings; 

4. Shall adjourn the meetings when such adjournment is in the public interest; and 

5. Chairs the meeting when directed by the Secretary of Agriculture or the Secretary’s designee. 

 Appendix D - PARLIAMENTARY PROCEDURE AT A GLANCE 

 

TO DO THIS YOU SAY THIS 

May 

you 

interru

pt 

speake

r?

Must you 

be 

seconde

d?

Is the 

motion 

debatabl

e?

Vote 

requi

red

Adjourn the 

meeting 

I move that we 

adjourn no yes no

majo

rity

Recess the meeting I move that we 

recess until... no yes no

majo

rity

Complain about 

noise, room 

temperature, etc. 

Question of privilege yes no no

no 

vote

Suspend further 

consideration of 

something 

I move that the 

motion be laid on the 

table 

no yes no

majo

rity

End debate I move the previous 

question no yes no

2/3 

vote

Postpone 

consideration of 

something 

I move we post pone 

this matter until... no yes yes

majo

rity

Have something 

studied further 

I move to refer the 

motion to the 

committee 

no yes yes

majo

rity

Amend a motion I move to amend... no yes yes

majo

rity

Introduce business 

(a primary motion) I move that... no yes yes

majo

rity

Object to 

procedure or to a 

personal affront 

Point of order yes no no

chair 

decid

es

Request 

information Point of information yes no no

no 

vote

Ask for a vote by 

actual count to I call for a division no no no

no 

vote

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 195/302
verify a voice vote 

Object to the 

consideration of 

some undiplomatic 

matter

I object to the 

consideration of the 

question 

yes no no

2/3 

vote

Take up a matter 

previously tabled 

I move to take from 

the table no yes no

majo

rity

Reconsider 

something already 

disposed of 

I move to 

reconsider... yes yes yes

majo

rity

Consider 

something vote 

out of its 

scheduled order 

I move we suspend 

the rules and 

consider... 

no yes no

2/3 

vote

Vote on a ruling by 

the chair 

I appeal the decision 

of the chair yes yes yes

majo

rity

Table a motion -

take matter from 

table

I move to take from 

the table No Yes No majority

Rescind motions –

Cancel previous 

action

I move to rescind No Yes Yes 2/3 

vote

Appendix E - BASIC CHEMISTRY 

The science of chemistry deals with the structure of matter--material things--and the changes that 

matter undergoes. Matter can exist in any size, shape, or color. It is solid, liquid, or gas; living or 

nonliving. Chemistry seeks to identify the simplest parts of matter; how they are separated and 

purified; how they are put together; how they are rearranged to produce new forms of matter; and 

what energy is absorbed or released when such rearrangements are made (Matta and Wilbraham, 

1986). A distinction should be made between chemical and physical changes. The OFPA and NOS 

definition of synthetic specifically mentions chemical change but not physical change. A physical 

property is a quality or condition of a substance that can be observed or measured without changing 

the substance’s composition. It can be specified without reference to any other substance. Other 

physical properties of matter include color, solubility, mass, odor, hardness, density, electrical 

conductivity, magnetism, melting point and boiling point. Physical properties help chemists identify 

substances (Matta and Wilbraham, 1986). When contractors are hired to technical review of 

substances for the NOSB and USDA/NOP, they typically list the physical properties of the substances 

in their review because this is the common way in which substances are described. 

 Physical changes may result when the temperature of a substance changes. Raising the 

temperature of a solid may turn it into a liquid (i.e., ice turns into water). A conversion without 

causing a change in the composition of the substance is called a physical change (Matta and 

Wilbraham, 1986). When ice undergoes the physical change of melting, this change does not 

change the nature of water. The physical properties are the same for water that has been frozen 

and melted as for water that has been converted into steam and then condensed (Matta and 

Wilbraham, 1986). Historically, the organic industry and the NOSB have acknowledged that physical 

changes do not render a substance synthetic. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 196/302
However, there are some substances that have been identified where high temperatures during 

manufacturing do engender a chemical change in the substance. An example is mined minerals. 

Historically, the industry and NOSB has recognized that burning or excessive heating of mined 

mineral is considered to render them synthetic. Formerly, NOSB defined mined minerals as any 

naturally-occurring non-living substance derived from the earth or water. A mined mineral cannot 

have undergone molecular change through heating, acidification, basification or fortification with 

synthetic materials (NOSB Final Recommendation Addendum Number 25, Definitions and 

Interpretations, Austin, Texas, 1995). Therefore, heat can alter the physical properties of a 

substance and for other substances act as a catalyst in chemical reactions or change. 

In a chemical reaction, the starting substance or substances, referred to as reactants, are changed 

into new substances or products. Chemists use an arrow as a shorthand form of the phrase “are 

changed into”; reactants products (Matta and Wilbraham,1986). An example to distinguish 

between physical and chemical changes is illustrated when sulfur (a solid) is added to iron filings (a 

solid). They may be separated unchanged from a mixture of the two substances mixed together. 

This separation is an example of a physical change. If the mixture of these two substances is heated, 

a chemical change takes place and the sulfur and iron are changed into a nonmagnetic substance, 

iron sulfide: Iron + Sulfur Iron Sulfide (Matta and Wilbraham, 1986). A substances’ composition and 

behavior in chemical reactions--its chemical reactivity--comprise its chemical properties. 

 

What is a substance? 

 In chemistry, a pure substance is a homogenous material that has a definite chemical composition 

throughout. There are two kinds of pure substances. One kind can be decomposed into two or 

more different substances by simple chemical change; these are called compounds. There are many 

millions of compounds. 

An example of a compound is pure table salt, which can be decomposed into sodium and chlorine by 

an appropriate process. Many of the substances on the National Lists of Synthetic substances 

allowed for use in organic crop and livestock production (Sections 205.601 and 205.603) are 

compounds. Examples include: isopropanol, chlorine dioxide, ammonium carbonate, lime sulfur 

and copper sulfate. 

 

The second kind of pure substances are called elements, which cannot be decomposed by chemical 

change. There are 90 natural elements; examples are gold, copper, oxygen, sulfur and hydrogen. 

Elements cannot be separated into simpler substances by chemical reactions. An example of an 

element on the National List is sulfur (elemental) for crop production (205.601(e)(3))(Boikess and 

Edelson, 1978). 

 

 Mixtures consist of a physical blend or two or more substances in which the combined substances 

retain their identity. Most materials found in nature are mixtures. Mixtures can be either 

homogeneous (same composition throughout) or heterogeneous (has non-uniform composition). A 

solution is a type of a mixture where there is a homogeneous combination of different substances. 

The difference between a heterogeneous mixture and a solution is that any sample of a solution has 

the same composition, while the composition of a mixture is not the same throughout. Solutions 

may be gaseous, liquid or solid. Examples of mixtures on the National List are aquatic plants and 

fish emulsions. The various compounds and elements that make up these products are within the 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 197/302
plant, animal or mineral. When a particular component of the plant is desired for use in an 

agricultural input it typically has to be extracted and in many cases undergo additional chemical 

reactions to make it into a substance that is functional when combined with other substances. 

 

 A distinction should be drawn between a mixture and a compound. The elements making up a 

compound cannot be recovered without a chemical change. The substances making up a mixture 

or solution can. Some mixtures can be separated into their various components by simple physical 

methods. An example is a gray-colored mixture produced by stirring together powdered yellow 

sulfur and black iron filings. The individual particles of sulfur and iron can be readily distinguished 

from one another under a microscope. The mixture is easy to separate because the iron filings can 

be removed from the mixture with a magnet leaving sulfur behind. Both the sulfur and the iron are 

unchanged in composition (example from Matta and Wilbraham, 1986). 

 

The substances making up a mixture or a solution need not be elements. For example, one can 

prepare a solution by dissolving salt, a compound, in water another compound. In addition, the 

substances making up a mixture or a solution can be combined in varying proportions. The 

elements in a compound have fixed proportions (paragraph found in Boikess and Edelson, 1978). 

Main groups of compounds can be classified based on similar chemical properties.The following are 

descriptions of each group (Boikess and Edelson, 1978). 

Salts: a compound of a metal and nonmetal, or of a metal with a negative polyatomic group. 

Compounds that have an ammonium group (NH4+) instead of a metal are also classified as salts. 

Some salts are NaCl, KCl, KMnO4 and NH4Cl. A salt is an ionic solid a room temperature. Most have 

two ionic components (a) a cation, which can be a polyatomic group such as ammonium or a 

monoatomic metal such as Na+, K+, Ca2+ or Mn3+ and (b) an anion, which can be a negative 

polyatomic group or a monoatomic ion such as Cl- or NH3-. A solid salt consists of ions in close 

association. When the salt dissolves in water, the ions are separated. Substances that exist as ions in 

solution are called electrolytes. When NaCl dissolves in water, the correct formula is Na+ + Cl-. This 

formula treats the component ions of the salts as independent entities, which is approximately how 

they behave in water solution. Salts are called strong electrolytes because they usually separate 

completely into ions in water. (Boyd text) 

Acids: a compound that is a source of H

+

 ions. An acid is usually a compound of hydrogen and a 

nonmetal or a negative polyatomic group. Unlike salts, acids usually are not aggregates of ions. An 

acid may be a gas (hydrochloric), liquid (sulfuric) or a solid (oxalic). Like salts, acids tend to form ions 

when the dissolve in water. When a substance separates into ions it is said to dissociate. Some 

acids dissociate completely and are called strong acids. Most acids dissociate only partially when 

dissolved in water. These are called weak acids, they are weak electrolytes. 

 

Bases: a compound that is a source of OH- ions in water solution. A compound of a cation and the 

OH- anion is a base. Bases resemble salts in many ways. They are ionic solids that dissociate into 

ions when dissolved in water. Bases that contain a cation and OH- are generally dissociate 

completely in water and are classified as strong bases. Some strong bases are NaOH (sodium 

hydroxide) and KOH (potassium hydroxide). Compounds that do not contain hydroxide ions are 

defined as bases if they produce OH- ions by reaction with water. An example is ammonia (NH3) 

which reacts with water to produce hydroxide ions. 

 

Nonelectrolytes: Compounds containing only nonmetals usually exist as discrete molecules, rather 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 198/302
than collections of ions. These compounds do not dissociate into ions when they dissolve in water. 

Many organic compounds are nonelectrolytes and they will not dissolve appreciably in water i.e. oil. 

Some will dissolve in water, although they will not dissociate into ions i.e. sugar, and ethyl alcohol. 

 

Oxides: is a binary compound of any element with oxygen, when the oxygen has an oxidation 

number of 

-2

. Almost every element forms at least on oxide. The properties of oxides vary widelydepending on the element they may resemble a salt, acid, base or non electrolyte. 

 

What constitutes a chemical change? 

The chemical properties of a substance are those that describe the way in which it can undergo 

change, either alone or in interactions with other substances, to form different materials. Such 

changes are called chemical reactions. The chemical properties that are characteristic of any 

substance can be described- iron combines readily with oxygen to form the compound called rust. 

(Boikess and Edelson, 1978). 

The following are common types of chemical reactions that describe what is happening when 

different substances and compounds interact (Boikess and Edelson,1978). 

1. Addition or combination reaction: Two substances combine to form one: 

2Na+Cl

2

----2NaCl 

2. Decomposition reactions: One compound breaks into two or more compounds or elements. 

 CaCO

3

-------CaO + CO

2

 

3. Displacement reactions: Substances exchange parts. There are many types of these reactions 

but one of the most important is called metathesis which is the exchange of ions by two ionic 

compounds, with the anion of one compound joining the cation of the other compound and vice 

versa. AB+CD-AD + CB 

a. 1. Hydrolysis is a displacement reaction of a substance or ion with water. Water is a 

source of both H

+

 and OH

-

 ions. The OH

-

 anion combines with the positive portion of the 

compound that is hydrolyzed. This positive portion may be a cation or an atom with a 

positive oxidation number. The H

+

 cation combines with the negative portion of the 

compound, which may be an anion or an atom with a negative oxidation number. 

b. Acid-base reaction: an acid is a substance that can donate a proton, and a base is a 

substance that can accept a proton. 

 

Since many materials used in organic agriculture are derived from plants and animals it is important 

to mention chemical reactions that occur in by products of these organisms. In living organisms, 

enzymes play the role in catalyzing a specific reaction or type of reactions. 

Proteins are substances extracted from living organisms that maybe utilized in materials that are 

petitioned for use in organic production. Proteins are sensitive to relatively small changes in pH, 

temperature, or solvent composition may cause them to denature. Denaturation causes physical 

change, the most observable result is loss of biological activity. Except for cleavage of disulfide 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 199/302
bonds, denaturation stems from changes in secondary, tertiary, or quaternary structures through 

disruption of noncovalent interactions, such as hydrogen bonds, salt linkages and hydrophobic 

reactions. Common denaturing agents include the following: 

1. Heat--most become denatured when heated above 50-60 degrees C. 

2. Large changes in pH--adding concentrated acid or alkali to a protein in a aqueous solution 

causes changes in the charged character of ionizable side chains and interferes with salt 

linkages. 

3. Detergents--treating a protein with sodium dodecylsulfate (SDS), a detergent, causes the native 

conformation to unfold and exposes the nonpolar protein side chains to the aqueous 

environment. These side chains are then stabilized by hydrophobic interaction with 

hydrocarbon chains of the detergent. 

4. Organic Solvents- such as alcohols, acetone or ether. 

5. Mechanical treatment. Most globular proteins denatured in aqueous solution if they are stirred 

or shaken vigorously. 

6. Urea and guanidine hydrochloride- These substances can cause disruption of protein hydrogen 

bonding and hydrophobic interactions. 

 

Denaturation can be partial or complete. It can also be reversible or irreversible. Irreversible 

denaturation causes a fundamental change in the protein, in particular destroying any physiological 

(biological) activity. In the case of reversible denaturation, the change may only be temporary 

(Brown, 1988). 

 

References: 

 

Boikess, R.S. and Edelson, E. Chemical Principles. Harper and Row, New York, 1978. 

Brown, W.H. Introduction to Organic Chemistry. Brooks/Cole Publishing Company, California, 1988. 

Matta, Michael, and Wilbraham, A.C. General, Organic and Biological Chemistry. Benjamin/Cummings 

Publishing Company, California, 1986. 

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 200/302
National Organic Standards Board

Policy Development Subcommittee

Discussion Document: Sunset Review Efficient Work Load Reorganization 

February 23, 2016

INTRODUCTION:

At present, the National Organic Standards Board (NOSB) conducts sunset reviews of materials 

according to the same schedule that the materials were added to the National List. Since the 

majority of materials on the National List were first included when the organic regulations were 

published in 2002, the number of materials reviewed each year by the NOSB is radically 

disproportionate. The peak of required reviews in 2/7 review cycle1 (2022/2027) with 187

material listings (estimated) and corresponds to the date that most materials were added on 

the National List with the promulgation of the final role in 2002. In contrast the 4/9 cycle

(2019/2024) has only 1 material set for review. The sum of all years other than the 2/7 cycle is 

31 (estimated). Reviewing 187 materials in one year and 27 materials over 4 years is an 

inefficient use of resources and board time.

BACKGROUND: 

The National List identifies synthetic substances that may be used in organic production and 

nonsynthetic (natural) substances that may not be used. It also includes non-organic substances 

that may be used in or on processed organic products.

As provided for by the “sunset provision” of the Organic Foods Production Act, (OFPA) “No 

exemption or prohibition contained in the National List shall be valid unless the National 

Organic Standards Board has reviewed such exemption or prohibition...within 5 years of such 

exemption or prohibition being adopted or reviewed and the Secretary has renewed such 

exemption or prohibition (7 U.S.C. 6517(e)).” 

The National Organic Standards Board (NOSB) reviews materials on the National List on a 

schedule that ensures each material is reviewed prior to the end of this five-year period. By 

giving each material its due consideration, the NOSB can offer recommendations to the 

Secretary (via USDA National Organic Program) as to whether materials should be removed 

from the National List. The review of each material can be significant, as it involves research 

1 A Note of terminology used to talk about sunset review cycles. Sunset review cycles occur every five 

years on a predictable pattern. To facilitate brevity in this document the review cycle will termed by the 

last year digits – so an item on the current 2018 sunset review would be part of the 3/8 sunset review 

cycle. 

Terminology used Current Sunset Cycle Next Sunset Review year

0/5 cycle 2020 (reviewed in 2018) 2025 (reviewed in 2023)

1/6 cycle 2021 (reviewed in 2019) 2026 (reviewed in 2024)

2/7 cycle 2022 (reviewed in 2020) 2027 (reviewed in 2025)

3/8 cycle 2018 (reviewed in 2016) 2023 (reviewed in 2021)

4/9 cycle 2019 (reviewed in 2017) 2024 (reviewed in 2022)

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 201/302
(including completion of technical reports by a third party, upon NOSB’s request), debate 

among the NOSB, public comment periods, and public meetings. Public comment includes 

considerable time and resources by a wide array of stakeholders, including thousands of pages 

of detailed written reports for every material, and these must be prepared in a very short 

period of time The NOP currently allows for approximately two years for each material to 

complete the sunset review cycle, and materials that “sunset” in 2018 are being considered in 

2016 by the NOSB. 

The advantages of a more even distribution of this work include: 

• More balanced attention for individual materials, regardless of the date added to the 

National List

• Predictable and balanced materials workload for NOSB

• Reduced strain on NOP in supporting the NOSB’s reviews during peak years, including 

coordination and review of technical reports and rulemaking actions

• Greater efficiencies in time and staff resources at NOP

• More reasonable number of items for the public to comment on in the limited time 

provided under the regulations.

Advancing the review of materials is the only way to resolve the distribution problem. Without 

any change, the disproportionate number of materials that sunset in 2017 will again come up 

for review in 2022. Since the review workload is lighter in all other years of the five year cycle 

than 2017, the NOSB could achieve an even load most quickly by advancing review as soon as 

possible after the 2017 materials have completed the renewal process.

RELEVANT AREAS OF THE RULE: 

“No exemption or prohibition contained in the National List shall be valid unless the National 

Organic Standards Board has reviewed such exemption or prohibition...within 5 years of such 

exemption or prohibition being adopted or reviewed and the Secretary has renewed such 

exemption or prohibition (7 U.S.C. 6517(e)).” 

DISCUSSION:

The following items were consider in the proposal to reorganize the 2/7 review. 

3/8 cycle excluded – Items will not be moved from the 2/7 to the 3/8 because of timing - items 

would need to be included in 2016 review occurring concurrent to this discussion document. 

Additionally, items should be “reviewed” after the program has “renewed” items on the 

national list. This renewal step will take place no later than 3/17/2017 when the first 2017 

material reached 5 years from its last renewal. Since reviews occur 2 years prior to sunset 

review date 2018 materials need to be reviewed prior to 3/17/2017. 

Only materials on the 2/7 cycle subject to early review- Only items from the 2/7 cycle are being 

evaluated for an early review. Items on other cycle will remain where they are even if earlier 

review would led to a more efficient review. Since materials may be added or removed from 

the list in any year, a perfectly even work load in unrealistic. 

Materials voted for removal during 2016 and 2017 Sunset Review Excluded. Items voted for 

removal under the 2016 and 2017 sunset review are excluded from this process and accounting 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 202/302
of materials since these materials should be removed from the National List prior to 

implementation of these proposals. 

Material Removals – Farmers, livestock operations and handling operations need to operate 

under a predictable business environment. These business are planning operations and 

researching new alternative materials on a 5 year cycles. Items reviewed early under the 

reorganization plan should be allowed to sunset on their original timeline in 2022. To do this, 

the NOSB will modify their sunset review documents to specify a 2022 removal and work in 

collaboration with the program to delay rulemaking until 2022. 

Workload – Workload should be roughly even amongst the 5 years. Materials should be split by 

sub- committee to even the workload of each subcommittee. Since materials may be added or 

removed from the list in any year, a perfectly even work load is unrealistic. 

Impartial and Efficient - The process of reorganization should be as impartial and non-political 

as possible while also being efficient. The most impartial reorganization reviews materials 

sequentially based on their listing on the national list. The most efficient reviews would group 

like items and groupings (i.e. all soil amendments) into the same year so the full list of materials 

could be considered. However, this can only be done in a limited way since only items of the 

2/7 cycle are being reorganized. There are a number of options that balance impartiality and 

efficiency with different weights. 

Method for Reorganization:

The following proposals are being considered for reorganization. The NOSB is seeking comment 

from the public on the preferred plan for reorganizing the sunset review process. Items voted 

to be removed in the 2016 and 2017 review are not included on the lists below. One of the 

proposals, “Current State” is to make no changes to the present sunset review process.

PROPOSALS CONSIDERED: 

Attachment A shows the National list substances and the proposed next sunset review year 

under the various proposals.

Current State/Control: 

• for reference – no change

Subcommittee 2018 2019 2020 2021 2022 Grand Total

CS 7 1 4 2 52 66

HS 10 2 5 94 111

LS 41 41

Grand Total 17 1 6 7 187 218

Option A: Straight division sequentially by reference number

• 3/8 cycle excluded

• 205.601, 205.602, 205.603, 205.604, materials on the 2/7 cycle are reorganized to the 

4/9, 0/5, 1/6, 2/7 cycle sequential starting at 205.601 (a). Items on 205.605(a) 

205.605(b) and 205.606 items are alphabetize within their own list and reorganized 

sequential amongst the same 4 review cycles. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 203/302
Subcommittee 2018 2019 2020 2021 2022 Grand Total

CS 7 14 17 15 13 66

HS 10 23 26 29 23 111

LS 11 10 10 10 41

Grand Total 17 48 53 54 46 218

Option B: Like grouping referred together, groupings combined to make even numbers

• 3/8 cycle excluded

• Items are grouped by similar items within lists. Items on 205.601 are reorganized by 

subsection (i.e. part (a), (b), (c), etc.). Items on 205.602 are considered in the same 

cycle. Items on 205.603 are broken up by type (i.e. parasiticides, sanitizers, etc.). Items 

are 205.604 are considered together. Items are grouped by 205.605(a), 205.605 (b) 1st

1⁄2 of 205.606 (when alphabetized) and 2nd 1⁄2 of 205.606 (when alphabetized) are put 

into each cycle. 

Subcommittee 2018 2019 2020 2021 2022 Grand Total

CS 7 15 19 13 12 66

HS 10 23 37 21 20 111

LS 12 10 11 8 41

Grand Total 17 50 66 45 40 218

RECOMMENDED PROPOSAL: 

Option C: Same items grouped together, divided by reference

• 3/8 cycle excluded

• Like items, regardless of listing section are grouped together by item (i.e. chlorine 

materials on 205.601, 205.603 and 205.605 are all grouped together) and reorganized to 

the year where they first appear on the list starting at 205.601(a). 

• 205.601, 205.602, 205.603, 205.604, materials on the 2/7 cycle are reorganized to the 

4/9, 0/5, 1/6, 2/7 cycle sequential starting at 205.601(a). Items on 205.605(a) 

205.605(b) and 205.606 items are alphabetize within their own list and reorganized 

sequential amongst the same 4 review cycles. 

Subcommittee 2018 2019 2020 2021 2022 Grand Total

CS 7 15 16 15 13 66

HS 10 27 27 27 20 111

LS 11 10 10 10 41

Grand Total 17 53 53 52 43 218

The PDS recommends option C as the best proposal to move forward with. The PDS believes 

this proposal achieves efficiency by grouping like items for review, allowing for TR’s to be 

coordinated across subcommittees and for reviews to take into account all facets of allowed 

usages across the organic industry. At the same time, the reorganization is impartial and blind 

to bias by using sequential reordering. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 204/302
REQUEST FOR PUBLIC COMMENT: 

We are seeking comment from the public on the following:

1) Which of the four options would be most advantageous for a reorganization of sunset 

review? 

2) If Option C is preferred are there other items that should be grouped together? (Later 

materials on the 2/7 reviews cycle will be reordered as a result of any changes earlier in 

the list). 

Vote in Subcommittee

Motion to accept the sunset timeline reorganization discussion document

Motion by: Tom Chapman

Seconded by: Ashley Swaffar

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

Attachment A

National 

List 

Section

Substance

Sunset/ 

Expiration 

Date

SC

Next Sunset Review Year under 

proposal:

Notes

Contr

ol

Optio

n A

Optio

n B

RECOMMEN

DATION: 

Option C

205.601(a) Calcium 

hypochlorite 6/27/2017 CS 2022 2019 2020 2019 

205.601(a) Chlorine dioxide 6/27/2017 CS 2022 2020 2020 2019

205.601(a) Copper sulfate 11/3/2018 CS 2018 2018 2018 2018

205.601(a) Ethanol 6/27/2017 CS 2022 2021 2020 2020

205.601(a) Hydrogen 

peroxide 6/27/2017 CS 2022 2022 2020 2021 

205.601(a) Isopropanol 6/27/2017 CS 2022 2019 2020 2022

205.601(a) Ozone 11/3/2018 CS 2018 2018 2018 2018

205.601(a) Peracetic acid 5/29/2018 CS 2018 2018 2018 2018

205.601(a)

Soap-based 

algicide/demosser

s

6/27/2017 CS 2022 2020 2020 2019 

205.601(a) Sodium carbonate 

peroxyhydrate 6/22/2020 CS 2020 2020 2020 2020 

205.601(a) Sodium 

hypochlorite 6/27/2017 CS 2022 2021 2020 2019 

205.601(b) Herbicides, soapbased 6/27/2017 CS 2022 2022 2019 2020 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 205/302
205.601(b)

Newspaper or 

other recycled 

paper

6/27/2017 CS 2022 2019 2019 2021 

205.601(b)

Plastic mulch and 

covers 

(petroleum-based 

other than 

polyvinylchloride 

(PVC))

6/27/2017 CS 2022 2020 2019 2022 

205.601(b)

Biodegradable 

biobased mulch 

film

10/30/201

9 CS 2019 2019 2019 2019 

205.601(c)

Newspaper or 

other recycled 

paper

6/27/2017 CS 2022 2021 2019 2021 

205.601(d) Soaps, ammonium 6/27/2017 CS 2022 2022 2021 2019

205.601(e) Ammonium 

carbonate 6/27/2017 CS 2022 2019 2021 2020 

205.601(e) Aqueous 

potassium silicate 6/22/2020 CS 2020 2020 2020 2020 

205.601(e) Boric acid 6/27/2017 CS 2022 2020 2021 2021

205.601(e) Copper sulfate 11/3/2018 CS 2018 2018 2018 2018

205.601(e) Elemental sulfur 6/27/2017 CS 2022 2021 2021 2022

205.601(e) Lime sulfur 6/27/2017 CS 2022 2022 2021 2019

205.601(e) Oils, horticultural 6/27/2017 CS 2022 2019 2021 2020

205.601(e) Soaps, insecticidal 6/27/2017 CS 2022 2020 2021 2021

205.601(e) Sticky 

traps/barriers 6/27/2017 CS 2022 2021 2021 2022 

205.601(e) Sucrose octanoate 

esters 6/27/2017 CS 2022 2022 2021 2019 

205.601(f) Pheromones 6/27/2017 CS 2022 2019 2021 2020

205.601(g) Vitamin D3 6/27/2017 CS 2022 2020 2019 2021

205.601(h) Ferric phosphate 9/12/2016 CS 2021 2021 2021 2021

205.601(i) Aqueous 

potassium silicate 6/22/2020 CS 2020 2020 2020 2020 

205.601(i) Copper sulfate 6/27/2017 CS 2022 2021 2020 2022

205.601(i) Coppers, fixed 6/27/2017 CS 2022 2022 2020 2019

205.601(i) Elemental sulfur 6/27/2017 CS 2022 2019 2020 2022

205.601(i) Hydrated lime 6/27/2017 CS 2022 2020 2020 2020

205.601(i) Hydrogen 

peroxide 6/27/2017 CS 2022 2021 2020 2021 

205.601(i) Lime sulfur 6/27/2017 CS 2022 2022 2020 2019

205.601(i) Oils, horticultural 6/27/2017 CS 2022 2019 2020 2020

205.601(i) Peracetic acid 5/29/2018 CS 2018 2018 2018 2018

205.601(i) Potassium 

bicarbonate 6/27/2017 CS 2022 2020 2020 2021 

205.601(j) Aquatic plant 6/27/2017 CS 2022 2021 2022 2022

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 206/302
extracts

205.601(j) Elemental sulfur 6/27/2017 CS 2022 2022 2022 2022

205.601(j) Humic acids 6/27/2017 CS 2022 2019 2022 2019

205.601(j) Lignin sulfonate 6/27/2017 CS - - - - Removed 

2017 

205.601(j) Liquid fish 

products 6/27/2017 CS 2022 2020 2022 2020 

205.601(j) Magnesium 

sulfate 6/27/2017 CS 2022 2021 2022 2021 

205.601(j) Soluble boron 

products 6/27/2017 CS 2022 2022 2022 2022 

205.601(j)

Sulfates, 

carbonates, 

oxides, or silicates 

of zinc, copper, 

iron, manganese, 

molybdenum, 

selenium, and 

cobalt

6/27/2017 CS 2022 2019 2022 2019 

205.601(j) Sulfurous acid 6/22/2020 CS 2020 2020 2020 2020

205.601(j) Vitamin B1 6/27/2017 CS 2022 2020 2022 2020

205.601(j) Vitamin C 6/27/2017 CS 2022 2021 2022 2021

205.601(j) Vitamin E 6/27/2017 CS 2022 2022 2022 2022

205.601(k) Ethylene 6/27/2017 CS 2022 2019 2022 2019

205.601(l) Lignin sulfonate 6/27/2017 CS 2022 2020 2019 2020

205.601(l) Sodium silicate 6/27/2017 CS 2022 2021 2019 2021

205.601(m)

EPA List 3 - Inerts 

of Unknown 

Toxicity

11/3/2018 CS 2018 2018 2018 2018 

205.601(m)

EPA List 4 - Inerts 

of Minimal 

Concern

6/27/2017 CS 2022 2022 2021 2022 

205.601(n) Hydrogen chloride 9/12/2016 CS 2021 2021 2021 2021

205.601(o) Microcrystalline 

cheesewax 3/15/2017 CS 2022 2019 2022 2019 

205.602(a) Ash from manure 

burning 6/27/2017 CS 2022 2020 2019 2020 

205.602(b) Arsenic 6/27/2017 CS 2022 2021 2019 2021

205.602(c) Calcium chloride 11/3/2018 CS 2018 2018 2018 2018

205.602(d) Lead salts 6/27/2017 CS 2022 2022 2019 2022

205.602(e) Potassium 

chloride 6/27/2017 CS 2022 2019 2019 2019 

205.602(f) Sodium 

fluoaluminate 6/27/2017 CS 2022 2020 2019 2020 

205.602(g) Sodium nitrate 10/21/2012 CS - - - - Invalid 

Listing

205.602(h) Strychnine 6/27/2017 CS 2022 2021 2019 2021

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 207/302
205.602(i) Tobacco dust 

(nicotine sulfate) 6/27/2017 CS 2022 2022 2019 2022 

205.603(a) Aspirin 6/27/2017 LS 2022 2019 2021 2019

205.603(a) Atropine 6/27/2017 LS 2022 2020 2021 2020

205.603(a) Butorphanol 6/27/2017 LS 2022 2021 2021 2021

205.603(a) Calcium 

hypochlorite 6/27/2017 LS 2022 2022 2019 2019 

205.603(a) Chlorhexidine 6/27/2017 LS 2022 2019 2019 2022

205.603(a) Chlorine dioxide 6/27/2017 LS 2022 2020 2019 2019

205.603(a) Electrolytes 6/27/2017 LS 2022 2021 2020 2019

205.603(a) Ethanol 6/27/2017 LS 2022 2022 2019 2020

205.603(a) Fenbendazole 5/16/2017 LS 2022 2019 2022 2020

205.603(a) Flunixin 6/27/2017 LS 2022 2020 2021 2021

205.603(a) Furosemide 6/27/2017 LS - - - - Removed 

2017 

205.603(a) Glucose 6/27/2017 LS 2022 2021 2020 2022

205.603(a) Glycerine 6/27/2017 LS 2022 2022 2020 2019

205.603(a) Hydrogen 

peroxide 6/27/2017 LS 2022 2019 2019 2021 

205.603(a) Iodine 6/27/2017 LS 2022 2020 2019 2020

205.603(a) Isopropanol 6/27/2017 LS 2022 2021 2019 2022

205.603(a) Ivermectin 6/27/2017 LS 2022 2022 2022 2021

205.603(a) Magnesium 

hydroxide 6/27/2017 LS 2022 2019 2021 2022 

205.603(a) Magnesium 

sulfate 6/27/2017 LS 2022 2020 2020 2021 

205.603(a) Moxidectin 5/16/2017 LS 2022 2021 2022 2019

205.603(a) Oxytocin 6/27/2017 LS 2022 2022 2021 2020

205.603(a) Peracetic acid 6/27/2017 LS 2022 2019 2019 2021

205.603(a) Phosphoric acid 6/27/2017 LS 2022 2020 2019 2022

205.603(a) Poloxalene 6/27/2017 LS 2022 2021 2021 2019

205.603(a) Sodium 

hypochlorite 6/27/2017 LS 2022 2022 2019 2019 

205.603(a) Tolazoline 6/27/2017 LS 2022 2019 2021 2020

205.603(a) Vaccines 6/27/2017 LS 2022 2020 2020 2021

205.603(a) Xylazine 6/27/2017 LS 2022 2021 2021 2022

205.603(b) Copper sulfate 6/27/2017 LS 2022 2022 2020 2022

205.603(b) Formic Acid 8/3/2017 LS 2022 2019 2020 2019

205.603(b) Hydrated lime 6/27/2017 LS 2022 2020 2020 2020

205.603(b) Iodine 6/27/2017 LS 2022 2021 2019 2020

205.603(b) Lidocaine 6/27/2017 LS 2022 2022 2021 2020

205.603(b) Mineral oil 6/27/2017 LS 2022 2019 2020 2021

205.603(b) Procaine 6/27/2017 LS 2022 2020 2021 2022

205.603(b) Sucrose octanoate 

esters 6/27/2017 LS 2022 2021 2020 2019 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 208/302
205.603(d) Methionine 10/2/2017 LS 2022 2022 2022 2019

205.603(d) Trace minerals 6/27/2017 LS 2022 2019 2022 2020

205.603(d) Vitamins 6/27/2017 LS 2022 2020 2022 2021

205.603(e)

EPA List 4 - Inerts 

of Minimal 

Concern

6/27/2017 LS 2022 2021 2022 2022 

205.603(f) Excipients 6/27/2017 LS 2022 2022 2022 2022

205.604(a) Strychnine 6/27/2017 LS 2022 2019 2019 2021

205.605(a) Agar-agar 11/3/2018 HS 2018 2018 2018 2018

205.605(a) Alginic acid 6/27/2017 HS 2022 2020 2019 2019

205.605(a) Animal enzymes 11/3/2018 HS 2018 2018 2018 2018

205.605(a) Attapulgite 8/3/2017 HS 2022 2021 2019 2020

205.605(a) Bentonite 6/27/2017 HS 2022 2022 2019 2021

205.605(a) Calcium carbonate 6/27/2017 HS 2022 2019 2019 2022

205.605(a) Calcium chloride 6/27/2017 HS 2022 2020 2019 2019

205.605(a) Calcium sulfate 11/3/2018 HS 2018 2018 2018 2018

205.605(a) Carnauba wax 6/27/2017 HS 2022 2021 2019 2020

205.605(a) Carrageenan 11/3/2018 HS 2018 2018 2018 2018

205.605(a) Citric acid 6/27/2017 HS 2022 2022 2019 2021

205.605(a) Dairy cultures 6/27/2017 HS 2022 2019 2019 2019

205.605(a) Diatomaceous 

earth 6/27/2017 HS 2022 2020 2019 2020 

205.605(a) Egg white 

lysozyme 9/12/2016 HS - - - - Removed 

2016 

205.605(a) Enzymes 6/27/2017 HS 2022 2021 2019 2019

205.605(a) Flavors 6/27/2017 HS 2022 2022 2019 2021

205.605(a) Gellan gum 6/22/2020 HS 2020 2020 2020 2020

205.605(a) Glucono delta

-

lactone 11/3/2018 HS 2018 2018 2018 2018 

205.605(a) Kaolin 6/27/2017 HS 2022 2019 2019 2022

205.605(a) Lactic acid 6/27/2017 HS 2022 2020 2019 2019

205.605(a)L-Malic acid 9/12/2016 HS 2021 2021 2021 2021

205.605(a) Magnesium 

sulfate 6/27/2017 HS 2022 2021 2019 2021 

205.605(a) Microorganisms 9/12/2016 HS 2021 2021 2021 2021

205.605(a) Nitrogen 6/27/2017 HS 2022 2022 2019 2020

205.605(a) Oxygen 6/27/2017 HS 2022 2019 2019 2021

205.605(a) Perlite 6/27/2017 HS 2022 2020 2019 2022

205.605(a) Potassium 

chloride 6/27/2017 HS 2022 2021 2019 2019 

205.605(a) Potassium iodide 6/27/2017 HS 2022 2022 2019 2020

205.605(a) Sodium 

bicarbonate 6/27/2017 HS 2022 2019 2019 2019 

205.605(a) Sodium carbonate 6/27/2017 HS 2022 2020 2019 2020

205.605(a) Tartaric acid 11/3/2018 HS 2018 2018 2018 2018

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 209/302
205.605(a) Wood resin 6/27/2017 HS 2022 2021 2019 2021

205.605(a) Yeast 10/21/2017 HS 2022 2022 2019 2022 

205.605(b) Acidified sodium 

chlorite 3/15/2017 HS 2022 2019 2020 2019 

205.605(b) Activated charcoal 9/12/2016 HS 2021 2021 2021 2021

205.605(b) Alginates 6/27/2017 HS 2022 2020 2020 2020

205.605(b) Ammonium 

bicarbonate 6/27/2017 HS 2022 2021 2020 2021 

205.605(b) Ammonium 

carbonate 6/27/2017 HS 2022 2022 2020 2020 

205.605(b) Ascorbic acid 6/27/2017 HS 2022 2019 2020 2022

205.605(b) Calcium citrate 6/27/2017 HS 2022 2020 2020 2019

205.605(b) Calcium hydroxide 6/27/2017 HS 2022 2021 2020 2020

205.605(b) Calcium 

hypochlorite 6/27/2017 HS 2022 2022 2020 2019 

205.605(b) Calcium 

phosphate dibasic 6/27/2017 HS 2022 2019 2020 2020 

205.605(b)

Calcium 

phosphate 

monobasic

6/27/2017 HS 2022 2020 2020 2020 

205.605(b) Calcium 

phosphate tribasic 6/27/2017 HS 2022 2021 2020 2020 

205.605(b) Carbon dioxide 6/27/2017 HS 2022 2022 2020 2021

205.605(b) Cellulose 11/3/2018 HS 2018 2018 2018 2018

205.605(b) Chlorine dioxide 6/27/2017 HS 2022 2019 2020 2019

205.605(b) Cyclohexylamine 9/12/2016 HS - - - - Removed 

2016 

205.605(b) Diethylaminoetha

nol 9/12/2016 HS - - - - Removed 

2016 

205.605(b) Diglycerides 6/27/2017 HS 2022 2020 2020 2022

205.605(b) Ethylene 6/27/2017 HS 2022 2021 2020 2019

205.605(b) Ferrous sulfate 6/27/2017 HS 2022 2022 2020 2019

205.605(b) Glycerin 6/27/2017 HS 2022 2019 2020 2020

205.605(b) Hydrogen 

peroxide 6/27/2017 HS 2022 2020 2020 2021 

205.605(b) Magnesium 

carbonate 6/27/2017 HS - - - - Removed 

2017 

205.605(b) Magnesium 

chloride 6/27/2017 HS 2022 2021 2020 2021 

205.605(b) Magnesium 

stearate 6/27/2017 HS 2022 2022 2020 2022 

205.605(b) Monoglycerides 6/27/2017 HS 2022 2019 2020 2019

205.605(b) Nutrient vitamins 

and minerals

10/21/201

7 HS 2022 2020 2020 2020 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 210/302
205.605(b) Octadecylamine 9/12/2016 HS - - - - Removed 

2016 

205.605(b) Ozone 6/27/2017 HS 2022 2021 2020 2021

205.605(b) Peracetic acid 9/12/2016 HS 2021 2021 2021 2021

205.605(b) Phosphoric acid 6/27/2017 HS 2022 2022 2020 2022

205.605(b) Potassium acid 

tartrate 6/27/2017 HS 2022 2019 2020 2022 

205.605(b) Potassium 

carbonate 6/27/2017 HS 2022 2020 2020 2019 

205.605(b) Potassium citrate 6/27/2017 HS 2022 2021 2020 2020

205.605(b) Potassium 

hydroxide 5/29/2018 HS 2018 2018 2018 2018 

205.605(b) Potassium 

phosphate 6/27/2017 HS 2022 2022 2020 2021 

205.605(b) Silicon dioxide 11/3/2018 HS 2018 2018 2018 2018

205.605(b) Sodium acid 

pyrophosphate 9/12/2016 HS 2021 2021 2021 2021 

205.605(b) Sodium citrate 6/27/2017 HS 2022 2019 2020 2022

205.605(b) Sodium hydroxide 6/27/2017 HS 2022 2020 2020 2019

205.605(b) Sodium 

hypochlorite 6/27/2017 HS 2022 2021 2020 2019 

205.605(b) Sodium 

phosphates 6/27/2017 HS 2022 2022 2020 2020 

205.605(b) Sulfur dioxide 6/27/2017 HS 2022 2019 2020 2021

205.605(b) Tetrasodium 

pyrophosphate 9/12/2016 HS - - - - Removed 

2016 

205.605(b) Tocopherols 6/27/2017 HS 2022 2020 2020 2022

205.605(b) Xanthan gum 6/27/2017 HS 2022 2021 2020 2019

205.606 Arabic gum 6/27/2017 HS 2022 2022 2022 2020

205.606 Beet juice extract 

color 6/27/2017 HS 2022 2019 2021 2021 

205.606 Beta

-carotene 

extract color 5/29/2018 HS 2018 2018 2018 2018 

205.606 Black currant juice 

color 6/27/2017 HS 2022 2020 2021 2022 

205.606 Black/Purple 

carrot juice color 6/27/2017 HS 2022 2021 2021 2019 

205.606 Blueberry juice 

color 6/27/2017 HS 2022 2022 2021 2020 

205.606 Carob bean gum 6/27/2017 HS 2022 2019 2022 2021

205.606 Carrot juice color 6/27/2017 HS 2022 2020 2021 2022

205.606 Casings 6/27/2017 HS 2022 2021 2022 2019

205.606 Celery powder 6/27/2017 HS 2022 2022 2022 2020

205.606 Cherry juice color 6/27/2017 HS 2022 2019 2021 2021

205.606 Chia (Salvia 

hispanica L.) 6/27/2017 HS - - - - Removed 

2017 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 211/302
205.606 Chokeberry

—

Aronia juice color 6/27/2017 HS 2022 2020 2021 2022 

205.606 Cornstarch 

(native) 6/27/2017 HS 2022 2021 2022 2019 

205.606 Dillweed oil 6/27/2017 HS - - - - Removed 

2017 

205.606 Elderberry juice 

color 6/27/2017 HS 2022 2022 2021 2020 

205.606 Fish oil 6/27/2017 HS 2022 2019 2022 2021

205.606 Fructooligosaccha

rides 6/27/2017 HS 2022 2020 2022 2022 

205.606 Galangal, frozen 6/27/2017 HS - - - - Removed 

2017 

205.606 Gelatin 6/27/2017 HS 2022 2021 2022 2019

205.606 Grape juice color 6/27/2017 HS 2022 2022 2021 2020

205.606 Grape skin extract 

color 6/27/2017 HS 2022 2019 2021 2021 

205.606 Guar gum 6/27/2017 HS 2022 2020 2022 2022

205.606 

Inulin-

oligofructose 

enriched

6/27/2017 HS - - - - Removed 

2017 

205.606 Kelp 6/27/2017 HS 2022 2021 2022 2019

205.606 Konjac flour 6/27/2017 HS 2022 2022 2022 2020

205.606 Lecithin—de-oiled 3/15/2017 HS 2022 2019 2022 2021

205.606 Lemongrass

-

frozen 6/27/2017 HS - - - - Removed 

2017 

205.606 Locust bean gum 6/27/2017 HS 2022 2020 2022 2022

205.606 Orange pulp, dried 3/15/2017 HS 2022 2021 2022 2019

205.606 Orange shellac

-

unbleached 6/27/2017 HS 2022 2022 2022 2020 

205.606 Paprika color 6/27/2017 HS 2022 2019 2021 2021

205.606 

Pectin (non-

amidated forms 

only)

6/27/2017 HS 2022 2020 2022 2022 

205.606 Peppers (Chipotle 

chile) 6/27/2017 HS - - - - Removed 

2017 

205.606 Pumpkin juice 

color 6/27/2017 HS 2022 2021 2021 2019 

205.606 Purple potato 

juice 6/27/2017 HS 2022 2022 2022 2020 

205.606 Red cabbage 

extract color 6/27/2017 HS 2022 2019 2021 2021 

205.606 Red radish extract 

color 6/27/2017 HS 2022 2020 2021 2022 

205.606 Saffron extract 

color 6/27/2017 HS 2022 2021 2021 2019 

205.606 Seaweed, Pacific 3/15/2017 HS 2022 2022 2022 2020

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 212/302
kombu

205.606 Sweet potato 

starch 6/27/2017 HS 2022 2019 2022 2021 

205.606 Tragacanth gum 6/22/2020 HS 2020 2020 2020 2020

205.606 Turkish bay leaves 6/27/2017 HS - - - - Removed 

2017 

205.606 Turmeric extract 

color 6/27/2017 HS 2022 2020 2021 2022 

205.606 

Wakame seaweed 

(Undaria 

pinnatifida)

6/27/2017 HS 2022 2021 2022 2019 

205.606 Whey protein 

concentrate 6/27/2017 HS - - - - Removed 

2017

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 213/302
NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 214/302
Sunset 2018 Review Summary 

Meeting 1 - Request for Public Comment

Handling Substances § 205.605(a), §205.605(b), §205.606 

April 2016 

Introduction

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

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

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

National List for use in organic handling that must be reviewed by the NOSB and renewed by the USDA 

before their sunset dates in 2018. This list provides the substance’s current status on the National List, 

use description, references to past technical reports, past NOSB actions, and regulatory history, as 

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

if any new technical report is available, please check for updates under the substance name in the 

Petitioned Substances Database. 

 

Request for Comments

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

fall 2016 public meeting, the NOP is requesting that the public provide comments about these 

substances to the NOSB as part of the spring 2016 public meeting. These comments should be provided 

through www.regulations.gov by April 6, 2016 as explained in the meeting notice published in the 

Federal Register. 

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

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

substances currently on the National List were added to the list based on evidence available to the NOSB 

at the time. The substances were found to be: (1) not harmful to human health or the environment, (2) 

necessary because of the unavailability of wholly nonsynthetic alternatives, and (3) consistent and 

compatible with organic practices. 

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

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

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

or whether the substance is no longer needed or in demand.

Guidance on Submitting Your Comments

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

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

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

For Comments That Support Substances Under Review:

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

provide information demonstrating that the substance is: 

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

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

nonsynthetic substitute products; and 

(3) consistent with organic handling. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 215/302
For Comments That Do Not Support Substances Under Review: 

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

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

Specifically, comments that support the removal of a substance from the National List should provide 

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

(1) harmful to human health or the environment; 

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

(3) inconsistent with handling. 

For Comments Addressing the Availability of Alternatives: 

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

review. Viable alternatives include, but are not limited to:

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

substance; 

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

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

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

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

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

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

For Comments on Nonorganic Agricultural Substances at §205.606.

For nonorganic agricultural substances on section §205.606, the NOSB requests current industry 

information regarding availability of and history of unavailability of an organic form of the substance in 

the appropriate form, quality, or quantity of the substance. The NOSB would like to know if there is a 

change in supply of organic forms of the substance or demand for the substance (i.e. is an allowance for 

the nonorganic form still needed), as well as any new information about alternative substances that the 

NOSB did not previously consider. 

Written public comments will be accepted through April 6, 2016 via www.regulations.gov. Comments 

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

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 216/302
Sunset 2018 Review Summary 

Meeting 1 - Request for Public Comment

Handling Substances § 205.605(a), §205.605(b), §205.606

April 2016

Reference: 7 CFR 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)).’’

(Linked below)

Agar-agar

Animal enzymes

Calcium sulfate-mined

Carrageenan

Glucono delta-lactone

Tartaric acid

Reference: 7 CFR 205.605(b) 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

Potassium hydroxide

Silicon dioxide

Reference: 7 CFR §205.606 Nonorganically produced agricultural products allowed as ingredients in or 

on processed products labeled as “organic.”

(d) Colors derived from agricultural products - Must not be produced using synthetic solvents and carrier 

systems or any artificial preservative.

(2) Beta-carotene extract color

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 217/302
Agar-agar

Reference: §205.605(a)

Technical Report: 1995 TAP; 2011 TR

Petition(s): NA

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

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. It can be 

found in bakery products, confections, jellies and jams, dairy products, canned meat and fish products, 

and vegetarian meat substitutes. Useful characteristic of agar-agar include that it can withstand high 

temperatures, and since it is practically tasteless and doesn’t require the addition of cations to form 

gels, it doesn’t interfere with taste profiles. It can be used in foods in combination with other thickening 

or gelling agents. It is classified as GRAS. 

Manufacture: 

Agar-agar is derived from red algae. The main species harvested are 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. (TR 2011, 165-176)

After pretreatment, the algae are placed in tanks for the extraction, via hot water pressure, and then 

filtration. The last step is to remove water from the gel either through a freeze thaw process or by 

mechanical pressure. The gels are then dried with hot air resulting in a finished product of flakes, strips, 

or powder. 

Based on this manufacturing information, the Handling Subcommittee acknowledges that a 

reclassification of agar-agar might be needed in the future once the NOP finalizes the Guidance for 

Material Classification. 

International: 

Agar-Agar is permitted for use in organic production by CODEX, the Commission of the European 

Communities, IFOAM, and Canada. 

Discussion: 

The 2011 TR did not find the substance to be harmful to human health, additionally the report stated 

that no excessive levels of heavy metals or other contaminants have been reported in agar-agar. 

In regards to whether the substance may be harmful to the environment or biodiversity, the TR stated 

there is limited evidence to suggest that the harvesting of agarophytes (algae used to make agar-agar) 

may be harmful to biodiversity. Additionally, harvesting wild agarophytes may also reduce biodiversity 

on nearby beaches. The TR concludes through that no studies were found to indicate whether or the not 

the harvesting of agarophytes in particular is harmful to the biodiversity or nearby beaches or in the 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 218/302
algae beds themselves (TR 2011 296-312). 

The NOSB is in the process of reviewing the use of all marine plants currently on the National List, for 

which a limited technical report will be requested. The marine plants topic will be reported on as a 

separate item at the Fall 2016 meeting. 

Additional information requested by NOSB: 

The 2011 TR provides possible agricultural alternatives to agar-agar in food applications, including: (1) 

gelling agents, such as pectin (high methoxy), gelatin, unmodified starches, and konjac flour; and (2) 

thickeners, emulsifiers, and stabilizers, such as vegetable gums (Arabic, locust/carob bean, guar), 

unmodified starches, tragacanth gum, konjac flour. 

1. Have there been any new developments with alternatives to agar-agar? 

2. Why is agar-agar used instead of alternatives? What are the unique characteristics that make it 

essential to organic handling? 

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 TR

Petition(s): NA

Past NOSB Actions: 11/2000 meeting minutes and vote; 11/2007 recommendation; 12/2011 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

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). (Technical Report 2011 

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. (TR 2011 727-728)

Manufacture: 

Traditionally the fourth stomach or other organs of goat kids or calves are 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. (TR 2011 444-458)

International: The use of enzymes is permitted in organic processing in Canada, EU, IFOAM and in 

CODEX. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 219/302
Ancillary substances: Explained in the Enzymes Technical Evaluation Report – Limited Scope, (NOP 

2015): 

“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 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. 

An additional ancillary substance proposal will be reviewed at a later date. 

Discussion: 

Evaluation question #9 in the 2011 TR does not find the manufacture or use of enzymes 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. 

Evaluation question #10 in the 2011 TR does not find significant effects upon human health. Enzymes 

can remain active after they are digested and, as proteins, cause allergic reactions in sensitive 

individuals (Tucker and Woods, 1995). FDA reports it is not aware of any allergic reactions associate with 

the ingestion of food containing enzymes commonly used in food processing (FDA, 1995). (TR 2011 752-

758). 

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 excluded 

methods. 

The 2000 TAP review for animal derived enzymes indicated that animal derived enzymes could be 

produced from organic livestock. 

Additional information requested by NOSB 

1. Are any animal derived enzymes currently being produced from organic livestock? If yes, on 

what scale? 

2. In the 2011 TR on Animal Enzymes, manufacture of the substance is focused on rennet. Please 

submit information if the manufacture of other types of animal enzymes differ from rennet. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 220/302
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

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Use: 

• Used as a coagulant 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)

• Gelling ingredient

• Used in baking powder

• Sequestrants, filler, carrier, pH buffer, abrasive agent

• Cosmetics and toothpaste

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 mining crude gypsum is ground 

and separated. It is normally sold as pure but may contain impurities of calcium carbonate and natural 

occurring silica. Calcium sulfate is GRAS. 

International: IFOAM – restricted “For soybean products, confectionery and in bakers’ yeast” but not 

restricted to mined sources. CODEX – restricted to “Cakes & biscuits/soy bean products/bakers yeast. 

Carrier,” but it is not restricted to mined sources. Japan – restricted to “Limited to be used as 

coagulating agent or used for the confectionary, the processed beans products or bread yeast,” but it is 

not restricted to mined sources. Canada – restricted to “as a carrier for cakes and biscuits; for soybean 

products; and for bakers’ yeast” with the restriction, “Sulfates produced using sulfuric acid are 

prohibited.” EU - 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 is not restricted to mined sources. 

Ancillary substances: None reported in 2001 TAP 

Discussion:

Information from the petition and 2001 TAP review maintain that this material is consistent with OFPA 

criteria. Unless new information is provided from the public about impacts to the environment or 

human health this material should be renewed. 

Additional information requested by NOSB: 

None

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 221/302
Carrageenan

Reference: §205.605(a)

Technical Report: 1995 TAP, 2011 TR; 2016 Limited Scope TR

Petition(s): NA

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987 –misspelled as 

‘carageenan’); Sunset renewal notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Use: 

Carrageenan (CAS # 9000-07-1) is a generic term referring to a family of linear polysaccharides (i.e., 

complex carbohydrate chains) that are extracted from species of red seaweeds (Class Rhodophyceae). It 

is an FDA-approved direct food additive with an average molecular weight of 200-800 kDa, and may be 

referred to as “undegraded” or “native” carrageenan in the literature. The actual molecular weight of 

food-grade carrageenan represents a spectrum of molecular weights that are naturally present in live 

seaweed.

Carrageenan can function as a bulking agent, carrier, emulsifier, gelling agent, glazing agent, humectant, 

stabilizer, or thickener. It can promote gel formation and thicken, stabilize and improve palatability and 

appearance of foods. It is typically used at a rate ranging from 0.03% to 0.75%, and its most common 

uses are in dairy products, non-dairy "milk" analogs, meats, and drink mixes. It has been used in food 

processing for more than 600 years.

During the last Sunset Review in 2012, the NOSB discovered that there was a lot of controversy 

surrounding this ingredient, both among the scientific community and the public. The scientific 

community disagreed over the research methodology used in studies and meta reviews that were not 

always consistent with how carrageenan behaves when ingested in food. Several public interest 

organizations were taking sides with one scientific group's approach over the others because of 

concerns that carrageenan caused inflammation or worse. The NOSB could not thoroughly investigate 

these issues within the very short period of time between the sunset announcement and the vote to 

renew. The members of the 2012 Handling Subcommittee did promise the public to do a more thorough 

analysis at the time of the next sunset review.

Therefore the Handling Subcommittee commissioned a Limited Scope Technical Report (TR, see link 

above) to supplement the one that was done in 2011. This report focused on the effects of the 

substance on human health: Evaluation Question #10. Very specific questions were posed about the 

research methodology regarding the molecular weights of carrageenan, the relative value of in vivo vs. 

in vitro studies, and the newest studies since the last TR was done in 2011.

The TR came back with the following statement, "Definitive conclusions regarding the varying degrees of 

human susceptibility to inflammation effects of carrageenan cannot be made from the available 

literature." (lines 173 - 174). And this, " However, since different animal species, different animals within 

the same species, and different human intestinal cell lines have produced different experimental results, 

it is reasonable to expect that humans may also experience varying degrees of sensitivity to carrageenan 

in the diet." (lines 177 - 180)

Members of the Handling Subcommittee have not decided on whether to propose removing 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 222/302
carrageenan from the National List. We are troubled that the research showing inflammation and 

glucose intolerance is all from one research team and has not been replicated. We hope that in the next 

few months before we vote more conclusive research replication or rebuttal will help inform our 

decision.

It is also worth noting that in the time since the last review the World Health Organization JECFA 

committee re-evaluated carrageenan for use in infant formula and changed their opinion on restricting 

its use to have an unrestricted status. (See TR for citation).

This is the first meeting of the two meetings at which carrageenan will be considered under the new 

sunset review process. All stakeholders can now read the new TR and try your best to mount arguments 

for one side or the other. It does come down to a core question of philosophy about the organic 

regulations: if humans have varying degrees of sensitivity to carrageenan in the diet, is that enough 

reason to prohibit it in all organic foods? Humans are also sensitive to gluten, dairy, legumes, and many 

other foods; is that a reason to keep them out?

Additional information requested by NOSB 

1. After the last review in 2012 we know some companies pledged to remove carrageenan from their 

products. Has this been successful and what alternatives have been used? Are there any products for 

which it has not been successful, and why?

2. Are there any stakeholders who rely on this material? If so for what uses and why have alternatives 

not been successful?

3. Is "sensitivity" to a food ingredient enough of a reason to prohibit a substance in organic products if it 

is clearly listed as an ingredient on a food label?

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

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Use: Glucono delta-lactone (GDL) is primarily used in the production of tofu, particularly in the 

production of silken tofu. In tofu production GDL serves as a coagulant. GDL can also be used as a 

curing agent, leavening agent, pH control agent and sequestrant. 

Manufacture: There are a variety of ways a GDL can be produced. The most common form has gluconic 

acid production is called the Blom process in which gluconic acid is produced by fermentation of glucose 

syrups by Aspergillus niger. Sodium hydroxide or calcium carbonate is added to this to produce 

gluconate salt. The gluconate salt is then isolated via evaporation, crystallization and then conversion to 

acid via ion-exchange. This process produces GDL via acid base reactions and fermentation (2016 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 223/302
Technical Review pgs. 10-11). Other processes to make GDL involve oxidation with bromine water 

(disallowed by the annotation on the National List) and oxidation with purified enzymes. 

International: GDL is not listed on the permitted substances lists of Canada, EU, Japan, Codex, or 

IFOAM. 

Ancillary Substances: 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. 

Discussion: The original petition and primary use of GDL is for the coagulation of tofu. Several 

coagulants for tofu exist including 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 

produces a different type of tofu texture and flavor, resulting in distinctly different products. Calcium 

salts produce firm tofu, sulfate salts produce soft tofu, and GDL produces silken tofu. Citrus and Lactic 

acids produce acidified tofu, which is often undesirable. Precise control of temperature and processing 

environments may allow different coagulants to produce different types of tofu. 

The 2016 Technical Review examined human health and environmental impacts of GDL use and 

production but found low to no risk. The review did raise the question of classification, given the 

substance is produced via fermentation and acid-base reactions similar to that of citric acid (also listed 

on 205.605(a) nonsynthetic). The technical review also raised concerns about the potential for GMO 

enzymes to be used in the production of GDL via the oxidation with enzymes production method, which 

is not the most common form of production. 

Additional information requested by NOSB 

1. Is GDL being used in applications other than tofu production for organic processed foods? 

2. If GDL was removed from the national list, are alternative tofu coagulants such as calcium and 

sulfate salts sufficient to produce all forms of tofu? 

3. Should GDL produced from enzymes be prohibited or further restricted due to concerns around 

GMOs? 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 224/302
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

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Uses: 

Tartaric acid is a natural organic acid that is 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. 

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, 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 

International:

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, 2011).

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). 

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, 

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). 

Additional information requested by NOSB

1. The Handling Subcommittee requests public comment on the use of Tartaric Acid and its 

essentiality in organic processing.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 225/302
Cellulose

Reference: §205.605(b) Cellulose - for use in regenerative casings, as an anti-caking agent (non-chlorine 

bleached) and filtering aid.

Technical Report: 2001 TAP; 2016 TR

Petition(s): 2001

Past NOSB Actions: 10/2001 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Use:

Cellulose (CAS # 9004-34-6 alpha cellulose) is available in several different forms with each having 

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. Uses in organic handling include: 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 hot dog and sausage casings. Some of these uses in organic handling have been around 

since even before the creation of OFPA, with cellulose being allowed by certifiers in organic cheeses 

since 1994 and for use in organic meat products since 1999.

Manufacture:

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)(TER 2-11-2016). Most commercially available 

cellulose (powdered) is produced from wood pulp (40-50% cellulose) or other plant sources (such as: 

corn cobs, soybean hulls, oat hulls, rice hulls, sugar beet pulp, etc.) through a delignification process that 

results in a chemically changed synthetic end product (Franz and Blaschek 1990: French et al. 1993). The 

original process for making regenerated cellulose is called the viscose method. It converts cellulose 

fibers into regenerated fibers and films and with some minor changes is still in use today (this process 

was invented in the 1890’s). The new Technical Evaluation Report (February 11, 2016) mentions several 

other sources of cellulose such as: from recycled paper and cardboard (US EPA 2015b) and microbially 

produced cellulose made from the fermentation of sugars with bacteria and microalgae. Cellulose is also 

currently being looked at in research studies in nanotechnology, according to information provided in 

the new TR (Hubbe et al. 2008) (Martirosyan and Schneider 2014).

International: Cellulose is permitted by most organic standards outside of the U.S. for at least some 

uses and applications in organic processing or handling.

• Canada – 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).

• IFOAM –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). 

Discussion:

During the previous Sunset Review cycle there were no sources of either nonsynthetic or organic 

cellulose identified. During the current cycle we will be asking organic handlers and other stakeholders 

to help provide answers to that question. There are numerous uses for cellulose in food handling, but 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 226/302
not all uses are allowed in organic food production/handling. The current annotation for cellulose in 

organic handling under §205.605(b) allows it to be used only as: a filtering aid, as a component of 

processed meat casings, or as an anti-caking agent. This is a material that was in use by organic handlers 

in organic food production even prior to the formation of the National Organic Program and the 

creation of the National List.

The new TR states that food-grade cellulose filters composed of either 100% or food grade 99%+ 

cellulose without ancillary ingredients are commercially available (ErtolAlsop 2015; Purifiber 2015; 

International Fiber Corporation 2015). There are other ingredients that sometimes may be added to 

reduce labor costs or increase the functional efficiency of cellulose for certain processes. While the TR 

(February 11, 2016) also mentions that these ancillary substances or ingredients may be added for other 

uses along with cellulose, it does make it very clear that for all of these uses there are well defined 

sources of commercially available cellulose that do not included these ancillary ingredients 

(International Fiber Corporation 2015).

The new TR does raise a couple of concerns regarding potential for environmental impact; specifically, 

depending on the source of the cellulose, there could be some concerns associated with the logging of 

the trees for wood, and some natural ecosystems have been replaced with fast-growing species of pulp 

trees (Roberts 2007). Recycling and the use of alternative crops will help to mitigate the impact. Some 

concerns have also been raised about cellulose waste generated from food processing, but these are a 

subject of current research to look at conversion of these wastes into useful products. (Das and Singh 

2004). Also, recycling and the use of alternative crops will help to mitigate the impact of cellulose 

manufacturing on biodiversity (Roberts 2007).

The TR also mentions that studies on both animal models and human subjects found cellulose to be 

non-toxic (LSRO 1973). Although cellulose is not explicitly listed as GRAS in 21 CFR 184, the Select 

Committee on GRAS Substances concluded that “[t]here is no evidence in the available information on 

pure and generated cellulose, including micro-crystalline cellulose, that demonstrates or suggests 

reasonable grounds to suspect, a hazard to the public when they are at levels that are current, or might 

reasonably be expected in the future” (SCOGS 2015).

During the October 16, 2001 NOSB Fall meeting the original discussion around listing cellulose for use in 

organic handling first took place regarding whether or not it should be added to the National List. At 

that time, it was determined that there were two sources of cellulose approved for use: regenerative 

casings, and powdered cellulose for use as anti-caking or as a filter aid. Part of the discussion during that 

time was considering adding the word “powdered” as part of the annotation. It was ultimately decided 

not to include the more restrictive addition as part of the original annotation for cellulose. During the 

last Sunset Review cycle at the Spring 2012 NOSB meeting it was discussed and voted on by the board to 

add the word “powdered” as part of the annotation. When the NOP did the 2013 Sunset Docket they 

were not able to make the change to the cellulose annotation voted on by the NOSB due to the lack of 

time needed to add changes, inform the public, and the need to determine/estimate the impact that 

this more restrictive annotation might have on organic stakeholders currently using this material. So it

remains un-clarified at this time if the word “powdered” should be added to the annotation as a means 

by which to limit the type of cellulose allowed for these particular uses or not. Also, at the Spring 2012 

NOSB meeting certifiers and handlers provided information to confirm that the microcrystalline form 

was not used in organic handling and that, per conversations with the NOP, it was also determined that 

this form of cellulose was not allowed for use in organic handling.

Additional information requested by NOSB 

1. Have there been any new sources for either a nonsynthetic or an organic form of cellulose 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 227/302
identified during this current Sunset Cycle? If so please provide the NOSB with information on 

this source.

2. Are there any new or potential uses not covered by the current annotation that should be 

brought to the NOSB’s attention? If so please explain.

3. Have there been any possible alternatives to any of the allowed uses for cellulose identified 

during this current Sunset Cycle, and if so please provide the NOSB with their names and how 

they compare to the use of cellulose for the specific use.

4. What impact would the inclusion of the word “powdered” as part of the annotation have on 

your handling process? Should the NOSB consider bringing forth a separate proposal to make 

this change to the cellulose annotation?

5. Could you help us to identify any ancillary substances that might be used with cellulose in 

organic handling or processing? The new Technical Evaluation Report mentions several 

potential ones for both powdered and the inedible form used in regenerative casings. Are any of 

these currently being used in organic handling and processing?

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 Amend annotation

Past NOSB Actions: 10/1995 meeting minutes and vote; 11/2005 recommendation; 12/2011 

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 Date: 5/29/2018

Uses: 

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. It is also used 

in the lye peeling of fruits and vegetables. The FDA lists potassium hydroxide as GRAS for humans (21 

CFR 184.1631), which are allowed under 21CFR 173.315(a)(1) - Chemicals used in washing or to assist in 

the peeling of fruits and vegetables. In fruit and vegetable peeling, potassium hydroxide serves to 

weaken the glycolytic bonds of pectin, which is responsible for skin adhesion. Weakening these bonds 

allows the peeling of fruit and vegetable skins by water spray or other mechanical methods. 

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.

International: 

• Canada - Canadian General Standards Board Permitted Substances List –Allowed for pH 

adjustment only. Prohibited for use in lye peeling of fruits and vegetables (CAN/CGSB 2011 

Table 6.6). 

• CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and 

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Marketing of Organically Produced Foods (GL 32-1999) – Allowed for pH adjustment for sugar 

processing (FAO/WHO Joint Standards Programme 1999, Table 4). 

• 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.”

• Japan Agricultural Standard (JAS) for Organic Production—“Limited to be used for processing 

sugar as pH adjustment agent” (Japan MAFF 2000). 

• IFOAM – Organics International (IFOAM) – Not found.

History:

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 which 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 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 Committee 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 commercially processing methods used for peaches, the NOSB full board 

favored removing the language regarding IQF methods so that the exception to the prohibition on lye 

peeling applies to all peach peeling.

Additional information requested by NOSB 

1. The Handling Subcommittee requests public comment on the use of potassium hydroxide and 

its essentiality in organic processing.

Silicon dioxide

Reference: §205.605(a) 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

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Past NOSB Actions: 09/1996 minutes and vote; 11/2005 recommendation; 12/2011 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 Date: 11/03/2018

Use: 

Synthetic amorphous silicon dioxide is used as a food additive for various functions including:

• An anticaking agent in foods

• A stabilizer in beer production, and filtrated out of the beer prior to final processing

• An adsorbent in tableted foods 

• A carrier 

• A defoaming agent 

Manufacture:

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) 

should be 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 organics the material would have to be 

petitioned to be 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: Silicon dioxide is permitted in organic handling by Canada, European Union, IFOAM, and 

Japan. In the EU its use is restricted to an anticaking agent for herbs and spices, of plant origin. In Japan 

its use is limited to processed foods of plant origin as gel or colloidal solution.

Ancillary substances: None reported in 2010 TR 

History:

In 2010 a 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 pass the petition. New data was presented in the petition claiming that a reformulation of the rice 

based alternative could now be substituted for silicon dioxide at nearly 1:1 rations, but 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 and even 

though they did not vote to remove silicon dioxide in its entirety they did pass (Yes: 11, No: 3) a 

recommendation to amend the annotation of silicon dioxide to:

§ 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) 

Synthetics allowed—Silicon dioxide—providing sufficient evidence showing nonsynthetic alternatives 

are not commercially available for a specific product/process is presented. 

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Resulting in its current listing as:

Silicon dioxide—Permitted as a defoamer. Allowed for other uses when organic rice hulls are not 

commercially available

The subcommittee in their 2010 recommendation also publically noted that additional information and 

clarification of processors’ needs regarding silicon dioxide would be needed for future deliberations by 

the NOSB. 

Discussion:

The 2010 TR did not find the manufacture or use of silicon dioxide to be harmful to people or the 

environment. The question that the subcommittee has is if silicone dioxide should remain on the list due 

to 205.600: 

(b) In addition to the criteria set forth in the Act, any synthetic substance used as a processing aid or 

adjuvant will be evaluated against the following criteria: 

(1) The substance cannot be produced from a natural source and there are no organic substitutes. 

Additional information requested by NOSB 

1. Are there instances where due to lack of availability of organic alternatives, you must use silicon 

dioxide? 

2. Are there instances where the organic alternative does not perform the needed function and 

therefore you must use silicon dioxide? If so, what are those functions? And what has been the 

undesired result when silicon dioxide was tried?

Colors: Beta-carotene extract

Reference: §205.606(d) Colors derived from agricultural products - Must not be produced using 

synthetic solvents and carrier systems or any artificial preservative 

(2) Beta-carotene extract color - derived from carrots or algae (pigment CAS# 7235-40-7).

Technical Report: 2011 TR

Petition(s): 2007, 2009

Past NOSB Actions: 04/2007 recommendation, 12/2011 recommendation

Recent Regulatory Background: National List amended 06/27/2007 (72 FR 35137); National List 

amended 05/28/2013 (78 FR 31815) 

Sunset Date: 5/29/2018

Discussion: 

Beta-carotene was petitioned by color manufacturers in 2007. No TAP was requested. The NOSB 

Handling Subcommittee rejected the petition to add this material to 205.606 stating: “the petitioner did 

not provide credible information regarding the lack of supply of organic raw material, and the ability to 

process them as organic”. (Vote: 4:1) 

However, at the March 2007 NOSB meeting the material was approved.

The Interim Final Rule (FR 35141) includes the following: “Though a significant number of comments 

were received, very few comments submitted were from processors or handlers. Comments from this 

segment of the industry would be helpful in developing a final rule. A number of comments expressed 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 231/302
concern regarding the information and criteria used for determining the fragility of the organic 

ingredient supply or organic availability of the proposed 38 nonorganic agricultural ingredients.“

The Interim Final Rule also includes the following: “As a result of the district court's final order and 

judgment in Harvey v. Johanns and requests for an extension of the public comment period on AMS-TM07-0062, AMS is issuing this interim final rule to: (1) Permit the use of the 38 ingredients during the 

extended comment and final rulemaking periods to minimize the impact to the organic industry; and (2) 

extend the comment period (60 days) to receive additional comments regarding the addition of the 38 

non-organic agricultural ingredients to § 205.606. Effective Date Effective June 9, 2007, these 38 

substances were prohibited for use in processed products labeled as ‘organic.’ Continued loss of the use 

of these products would disrupt the trade of food products currently being labeled as ‘organic’. 

Therefore, the continued use of these products as ingredients in foods labeled as ‘organic’ is necessary 

to prevent possible significant business disruption for organic producers and handlers. Accordingly, 

pursuant to 5 U.S.C. 553, it is found, and determined, upon good cause, that it is impracticable, 

unnecessary, and contrary to the public interest to give further notice prior to putting this rule into 

effect, and that good cause exists for not postponing the effective date of this interim final rule until 30 

days after publication in the Federal Register.“

In 2009, another manufacturer petitioned to add an amendment to the listing: “....Derived from carrots 

or algae”. The petitioner stated: “Our research over the past few years shows that at this time the only 

source of beta-carotene that can be extracted using NOP compliant nonsynthetic methods is algae. The 

algae derived beta-carotene uses extraction methods of CO2, ethanol or vegetable oil.” 

A Technical Report was requested and received in July 2011. 

The TR indicated that a common source of beta carotene color was derived from the micro-algae 

Dunaliella salina and Dunaliella bardawil. These species are cultivated in Australia, for example. The TR, 

lines 327-350, describes the intensive culture system of production in a high salt, nitrate rich medium. 

The TR further states: “Dunaliella species are commonly observed in salt lakes in all parts of the world 

from tropical to temperate to polar regions where they often impart an orange-red color to the water. 

As in commercial cultivation of the production, β-carotene is accumulated as droplets in the algal 

chloroplast stroma, especially under the environmental conditions in high temperature, high salinity, 

high irradiance, and nutrient limitation (low nitrogen). Then, β-carotene may be obtained from algal 

biomass or dried powder by using hot edible oil extraction and supercritical carbon dioxide, see EQ #2. 

In addition, it is desirable to re-utilize the culture medium remains after harvesting (biomass removal). 

Dunaliella growth medium could be recycled biologically by treating the medium with bacteria that are 

naturally present in medium because of the high concentration of glycerol, amino acids, and other 

organic compounds (Ben-Amotz, 1995). In a review article conducted by Dufosse et al. (2005), they 

concluded that algal forms are the richest source of pigments and can be produced in a renewable 

manner, since they produce some unique pigments sustainably. The report also stated that the 

production of β-carotene from Dunaliella will surpass synthetic as well as other natural sources due to 

microalgae sustainability of production and their renewable nature. (TR 530-545).

The TR supported the petitioner’s research findings. Therefore the Handling Subcommittee voted 4: 0 

with 3 absences to approve this amendment, and the NOSB in December 2011 voted 14: 0 to approve 

the amendment. 

The NOSB in 2011 found that the material met all the OFPA Criteria, and in 2013 the Final Rule was 

published (78 FR 31815).

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The NOSB is in the process of reviewing use of all marine plants which are presently on the National List, 

and will be requesting a limited Technical Report. The marine plants topic will be reported on as a 

separate item at the Fall 2016 meeting.

Additional information requested by NOSB 

1. Has there been any change in the ability of manufacturers to produce beta-carotene color from 

carrots using NOP compliant extraction methods?

2. Is this color necessary for organic processors?

3. Which species of algae are used and from where are they harvested?

4. If the typical species used are from the genus Dunaliella (as cited in the TR) is harvesting of these 

species of micro algae from the wild, certified wildcrafted, or cultivated? 

5. When used as a color, is this material also a source of Vitamin A?

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National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal - Sodium Lactate and Potassium Lactate

February 23, 2016

Summary of Proposed Action: To add Sodium Lactate and Potassium Lactate to the National List at

§205.605(b). NOP requested in a memorandum dated June 25, 2014 that the National Organic 

Standards Board review these materials. The original joint petition was submitted January 5, 2005, by 

Christopher Ely, Applegate Farms, on behalf of the manufacturers Purac America and Trumark Company. 

History

On January 5, 2004 the NOP received a combined petition for two substances to be added to the 

National List for use in organic handling, these substances were Sodium Lactate and Potassium Lactate

(the salts of lactic acid). Lactic acid is listed on the National List at §205.605(a) as an approved nonsynthetic material for use in products labeled as “organic” or “made with organic (specified ingredients 

of food group(s)). Lactic acid appears in “Acids (Alginic; Citric – produced by microbial fermentation of 

carbohydrate substances; and Lactic)”.

On January 22, 2004, the NOP notified the petitioner that their petition would not be necessary since 

the materials sodium and potassium lactate were composed of substances that were already included 

on the National List (sodium hydroxide, lactic acid, and/or potassium hydroxide). Eventually, this 

interpretation was deemed inconsistent with previous NOSB recommendations on the classification of 

materials and was causing some confusion within the organic industry regarding the status of the two 

materials (sodium lactate and potassium lactate) as well as other lactate salts (example: calcium lactate)

(McEvoy 2014). Thus, the NOSB (Handling Subcommittee) took up the request for the consideration of 

sodium lactate and potassium lactate for inclusion to the National List, §205.605 (b) Synthetics Allowed.

The original 2004 petition was submitted for the following use: Both sodium lactate and potassium 

lactate are used in meat processing as a pathogen inhibitor that is added to meat as an ingredient for 

use in controlling Listeria monocytogenes in Ready-to-Eat Meat and poultry products. Both of these 

materials have been recognized by the USDA-FSIS (Food Safety and Inspection Service) as being two of 

the few known antimicrobials validated through scientific studies to inhibit the growth of Listeria 

monocytogenes, E.coli, Salmonella, and other pathogens. They also control Clostridium Botulinum

(botulism) in meats as well. Sodium and potassium lactate can replace nitrates/nitrates in meat products 

and are generally recognized as safe (GRAS).

In the February 17th, 2015 Technical Evaluation Report it mentions that both sodium and potassium 

lactate are affirmed as GRAS. Sodium lactate is affirmed GRAS at 21 CFR 184.1768 and potassium lactate 

at 21 CFR 184.1639. However, the FDA does not authorize their use in infant foods and formulas.

Sodium lactate and potassium lactate come as a liquid and may be added to meat as an ingredient at 

the rate of 1% to 4.8% as prescribed by the USDA-FSIS regulations, depending on the product. Whether 

a handling operation uses sodium lactate or potassium lactate is at the discretion of the processor or by 

the requirements of the specific recipe – i.e. Low sodium products (Applegate Farms 2004). 

Manufacture:

Lactic acid is produced from the fermentation of natural food sources such as dextrose (from corn) and 

sucrose (from sugarcane or sugar beets) or starch. This substrate is fermented by food grade 

microorganisms to form Lactic acid. Sodium hydroxide is produced by the electrolysis of a concentrated 

sodium chloride (table salt) solution. Potassium hydroxide (KOH) is a synthetic, inorganic compound 

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produced by an electrolysis process using only potassium chloride (approved for use in organic foods per 

§205.605(a)) and water.

Sodium and/or Potassium lactate are generally produced from natural (fermented) lactic acid, which is 

then reacted with either sodium hydroxide or potassium hydroxide, respectively (Houtsma 1996). 

Lactates are naturally produced in the human body.

Discussion:

This proposal was referred back to the Handling Subcommittee at the fall 2015 NOSB meeting in Stowe, 

VT. The reason for doing so was to provide the subcommittee and board an opportunity to look into the 

other ways that these two materials were currently being used by organic handlers. This was based off 

of information provided to the full board during the public comment period.

 

The original petition asked that sodium and potassium lactate be added to the National List for use in 

meat processing as a pathogen inhibitor. While the petitioned request for these materials covered a 

very specific usage, it was not completely clear whether or not the petitioned use is currently the only 

way that these two materials are being utilized in organic handling. This is part of the confusion from the 

action taken in 2004 by the NOP’s decision to not accept the need for the petitioner’s request to have 

sodium lactate and potassium lactate added to the National List. 

Information provided during the written public comment period prior to and at the fall NOSB meeting in 

Stowe, Vermont by several commenters mentioned other ways that these materials were being used. . 

Some of those additional uses are: use in organic meat flavors (e.g. chicken flavor, beef flavor) and use 

in organic processed meats (e.g. sausages, meatballs, etc.). These are a few of the uses mentioned by 

one certifier about how some of their clients currently use these materials. Also, in comments provided 

both in written comments submitted and in oral testimony by an international certified organic handler, 

they have used sodium lactate in the manufacturing of their organic herb and spice pastes for 5 years 

prior to the NOP memo. It has become an integral part of their production process. They have tried 

other materials but so far sodium lactate provides the functional part of what they need and ask for it to 

be allowed for not only antimicrobial control, but also as a pH regulator. Sodium lactate helps them to 

maintain a balanced pH of their product, which is a critical parameter for both safety and product 

quality (Chang et al,2008; Nguefack et al, 2009; Canillac et al, 2004; Gurierrez et al, 2008) (9/30/2015 

Public Comment document: Botanical Food Company pg4). Some comments provided that the inclusion 

of these two materials onto the National List would help to eliminate the confusion that currently exists. 

There were some comments opposed to the listing of both materials, stating that they should not be 

allowed in organic processing further stating that they were intended for use as preservatives. It should 

also be noted that in the February 17th, 2015 Technical Evaluation Report, it states that: meat products 

that contain sodium or potassium lactate can no longer be labeled as “natural” without a case-by-case

assessment of what function these materials are serving in the product and at what levels (USDA FSIS 

2005). 

There are alternatives mentioned in the TR and the original petition such as: natural antimicrobials and 

agricultural antimicrobials (such as cranberry, cherry, lime and vinegar powders) (both currently being 

researched), essential oils, lactic acids, and bacteriophages (microorganisms) to name a few. 

There does not appear to be any human health concerns associated with either of these two materials 

according to the information provided in the Technical Evaluation Report. Both materials are considered 

to be GRAS by the FDA according to this same report. There was an environmental issue raised about 

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the amount of gypsum created in the manufacturing of lactic acid. This concern seems to have been 

mitigated by utilizing this by-product material (gypsum) as a soil additive (Gypsoil and ADM 2011)

(Feb.17, 2015 TR) and by research being implemented to look at other ways to produce lactic acid. 

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) (Feb.17, 2015 TR). 

In the Technical Evaluation Report from February 17, 2015 it does state that no additional ingredients 

(e.g., stabilizers, preservatives, carriers, anti-caking agents, or other materials) are added to the 

commercially available forms of these materials. Thus, there are no ancillary substances associated with 

either of these two materials. However, the TER does mention that sodium diacetate (below 2%) 

sometimes may be combined with either of these two materials to help lower the pH of the surface 

meat products and therefore decrease microbial growth. Sodium diacetate is GRAS, contains 60% 

sodium acetate and 40% acetic acid (Miller 2010) (Feb.17, 2015 TR). During the public discussion at the 

Stowe, Vermont NOSB meeting (Fall 2015) it was decided that sodium diacetate is an additional active 

ingredient sometimes used in conventional processing to enhance the microbial control measures and 

did not serve as an ancillary substance for this petitioned use as it applies to organic handling. 

Both sodium lactate and potassium lactate have been allowed for use in organic handling since the 

January 22, 2004 decision was rendered by the National Organic Program (McEvoy 2014). This decision 

(to not have sodium and potassium lactate petitioned for inclusion to the National List) was originally 

based on the fact that all three of the materials used to produce sodium lactate and potassium lactate 

were already approved and on the National List. That decision was not consistent with previous NOSB 

Recommendations on classification of materials. The intent of this proposal is to correct that previous 

decision and go through the appropriate process (Petitioned Material Proposal) to see whether or not 

these two materials should in fact be added to the National List of Allowed Substances. It is the intent of 

the subcommittee and ultimately that of the entire National Organic Standards Board by moving 

forward with this proposal we can clear up the confusion, re-establish a concise and transparent process 

by which these two materials shall be reviewed and ultimately voted on.

Sodium Lactate

There are three mechanisms by which sodium lactate can have an antimicrobial affect. The first is by 

changing water activity (it lowers the water activity of meat and thereby slows microbial growth). The 

second occurs as sodium lactate passes through the cell membrane and lowers intracellular pH. The 

third takes place as sodium lactate affects cellular metabolism by inhibiting ATP generation (ATPadenosine triphosphate, a nucleoside triphosphate which transports chemical energy within cells for 

metabolism (Biology Online 2010)). The lactic acid portion of sodium lactate has antimicrobial 

properties, as it can be incorporated into the microbial cell. The lactic acid then interferes or slows down 

the normal metabolic process that generates cell energy in the cell. (Miller 2010) (Feb.17, 2015 TR). 

Potassium Lactate

Potassium lactate has a potassium ion rather than the sodium ion found in sodium lactate. It has been 

shown to decrease microbial growth and to limit the growth of some major meat pathogens with similar 

capabilities to those of sodium lactate. Potassium lactate can be used as a substitute for sodium lactate 

as a non-meat ingredient, with similar functionality, but does not have the salty taste (Miller 2010)

(Feb.17, 2015 TR). 

Again, the original petitioned use for these materials was for use in Ready-to-Eat Meat and poultry 

products as an ingredient to function as a pathogen inhibitor, especially for use in providing microbial 

control of Listeria monocytogenes. 

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Information provided from public comments for the fall 2015 NOSB meeting made it clear that while 

both forms (sodium and potassium) lactate are used, sodium lactate seemed to be the one more 

commonly used. The rationale between the differences in use is primarily due to whether or not the use 

was for a sodium or a low sodium product. Also, as stated information provided by public comment and 

subcommittee, research does show that these two substances are currently used in organic handling in 

a variety of ways for several different uses other than just the original petitioned use.

Recently the original petitioner (formerly Purac and now Corbion Purac) contacted the NOP stating that 

they had just become aware that these two substances were back up for discussion. They were asked to 

submit their comments during the up-coming open public comment period in writing or during oral 

testimony. This helps to address one of the concerns from the Handling Subcommittee that if these 

materials were important in organic handling, then why hadn’t they heard from the petitioner or 

manufacturer. It was just brought to their attention. 

Please provide the full NOSB your comments on this proposal and if you are an organic handler currently

using either of these materials (or have used them prior to the NOP memo), if the proposed annotation 

would capture your current use pattern, assuming these two materials were added to the National List.

Also, could you explain why these substances would be preferred over currently used alternative 

materials or practices? 

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No ☒ N/A 

as Organic (only for §205.606)

Subcommittee Action & Vote: 

Classification Motion: Move to classify both sodium lactate and potassium lactate as synthetic.

Motion by: Harold V. Austin IV 

Seconded by: Ashley Swaffar 

Yes: 6 No: 0 Abstain: 0 Absent: 2 Recuse: 0 

Listing Motion: Move to list Sodium Lactate and Potassium Lactate at §205.605(b) of the National 

List with the following annotation: for use as an antimicrobial agent and pH regulator only.

Motion by: Harold V. Austin IV 

Seconded by: Tom Chapman 

Yes: 5 No: 0 Abstain: 1 Absent: 2 Recuse: 0 

 Proposed Annotation (if any): for use as an antimicrobial agent and pH regulator only.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 238/302
Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: To regulate how each of these substances are to be allowed for use in organic handling or 

processing.

Approved by Harold Austin, Handling Subcommittee Chair, to transmit to NOSB February 23, 2016

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National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal - Oat Beta Glucan

January 19, 2016

Summary of Proposed Action:

Oat beta glucan is being petitioned by manufacturer Tate & Lyle for addition at §205.606, as a natural 

component of oats, an agricultural commodity. According to the petition the substance is isolated 

through a simple process of grinding, enzyme treatment, water extraction and drying. No synthetic 

chemical additions or solvents are used in the manufacturing process being petitioned. The only 

additives used in producing oat beta glucan are water and enzymes. Specifically, the enzyme is foodgrade alpha-amylase and non-GMO per GRAS self-determination. In addition to the beta glucan, 

dextrains and gluco-oligosaccharides are found in the final product, which is in powder form. 

Due to oat beta glucan’s high soluble fiber content, bland flavor and minimal impact at low use levels, its

used to supplement fiber content in processed foods including biscuits, cakes, breads, cereals, bars, 

soups, and smoothies. Other common names for oat beta glucan include oat bran soluble fiber, oat 

fiber, oat soluble fiber, and oat bran fiber. 

Overall, oat beta glucan appears to have no significant negative impacts on human health. There have 

been studies that show the positive effect of the substance on lowering cholesterol and modulating 

blood glucose. 

The petition points out that oat beta glucan is used in handling, not crop production and thereby 

concludes that it has no effect on soil, crops, or livestock. The subcommittee however would like to 

point out that according to the USDA pesticide data program there are 7 pesticide residues found on 

conventionally grown oats. 

The petition points out that currently there is no source of organic oat beta glucan, despite organic oats 

and organics oat bran being widely available in the U.S. and Canada. Additionally the petition claims that 

in Nordic countries, where a large amount of oat beta glucan is manufactured, organic oats and organic 

oat bran quantities are limited. The petition goes on to state that if the demand for organic oat beta 

glucan was to increase, the Nordic manufacturing facilities could purchase organic oats and organic oat 

bran from the U.S. The petitioner thought this scenario was unlikely to happen soon due to the 

undetermined demand for oat beta glucan in organic form and that it would be more likely to happen if 

the use of non-organic beta glucan in organic foods was successful first. 

The handling subcommittee would like to point out that the global market is the universe of supply, noncommercial availability is not dependent on upon geographical location. The subcommittee sees no

reason why oat beta glucan could not be manufactured organically. In fact, the manufacturer Garuda 

International used to produce organic oat beta glucan but stopped doing so due to low demand. 

 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 241/302
Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes X No ☐ N/A

3. Compatibility & Consistency X Yes ☐ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No ☐ N/A 

as Organic (only for §205.606)

Substance Fails Criteria Category: 2- Essentiality and Availability. Comments: The Subcommittee felt 

that there were alternatives currently available and alternative sources for which these petitioned needs 

could be met. 

Subcommittee Action & Vote, including classification proposal (state actual motion):

Classification Motion: Move to classify Oat Beta Glucan as agricultural

Motion by: Lisa de Lima 

Seconded by: Ashley Swaffar 

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

Listing Motion: Move to list Oat Beta Glucan at §205.606 of the National List

Motion by: Lisa de Lima 

Seconded by: Jean Richardson 

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

 

Approved by Harold V. Austin IV, Handling Subcommittee Chair, to transmit to NOSB January 19, 2016

NOSB Evaluation Criteria for Substances Added To the National List - Handling

Category 1. Adverse impacts on humans or the environment? Oat beta glucan 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use or 

misuse of the substance? 

[§205.600(b)(2), [§6518(m)(3)]

x x Produced from non-organic oat, which 

according to the USDA pesticide data 

program, can contain 7 pesticide residues. 

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the substance? 

[§6518(m)(3)]

x

3. Are there any adverse impacts on 

biodiversity? (§205.200)

x

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

x

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5. Is there undesirable persistence or 

concentration of the material or breakdown 

products in the environment? [§6518(m)(2)]

x

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added to it? 

[§6517(c))(1)(A)(i); 6517 (c)(2)(A)(i); 

§6518(m)(4), 205.600(b)(3)]

x

7. Is the substance, and any ancillary 

substances, GRAS when used according to 

FDA’s good manufacturing practices? 

[§205.600(b)(5)]

x

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 (b)(5)]

x Not really sure, the appendix is not really 

legible. I don’t know if those limits are okay 

or not. 

Category 2. Is the Substance Essential for Organic Production? Oat beta glucan 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] x

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

x 

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

x

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

x Yes, natural because it uses enzymes. 

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

x

6. Is there an organic substitute? 

[§205.600(b)(1)]

x Currently no. Former producer of organic oat 

beta glucan stopped producing due to low 

demand.

7. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600(b)(6)]

x

8. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

x x Currently no, but could be made from 

organic oats

9. Are there any alternative substances? 

[§6518(m)(6)]

x x Yes, but petition claims they are unpalatable

10. Is there another practice (in farming or 

handling) that would make the substance 

unnecessary? [§6518(m)(6)]

x

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 243/302
11. Have the ancillary substances associated 

with the primary substance been reviewed? 

Describe, along with any proposed 

limitations. 

x No ancillaries reported in the petition 

Category 3. Is the substance compatible with organic handling practices? Oat beta glucan 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

handling? [§6517(c)(1)(A)(iii); 

6517(c)(2)(A)(ii)]

x

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible with 

organic handling? [§205.600(b)(2)]

x

3. Is the substance compatible with a system of 

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

x Not used in farming 

4. Are the ancillary substances reviewed 

compatible with organic handling [?

x Not ancillary substances identified in petition 

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

x

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

x Primary use is to increase fiber 

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law)? [§205.600(b)(4)]

x Primary use is to increase fiber

Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially unavailable? 

[§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Oat Beta Glucan

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the comparative description as to why the 

non-organic form of the material /substance 

is necessary for use in organic handling

provided? 

x Page 4 of the petition 

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling? 

x x Page 12 of the petition, gives their 

justification. 

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

x Page 12 petition

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 244/302
appropriate quality to fulfill an essential 

function in a system of organic handling? 

4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

x Page 12 petition 

5. Does the industry information about 

unavailability include (but is not limited to) 

the following?: 

a. Regions of production (including factors 

such as climate and number of regions);

x

b. Number of suppliers and amount 

produced;

x

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

x

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

x

e. Other issues which may present a 

challenge to a consistent supply?

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National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal - Hypochlorous Acid

February 16, 2016

Summary of Proposed Action:

On May 29, 2015 the NOP received a petition to add hypochlorous acid (CAS #7790-92-3) to the National 

List at §205.601 - Synthetic substances allowed for use in organic crop production. This material is being 

petitioned for use as an antimicrobial/sanitizer for use on equipment and raw agricultural products. The 

petition was forwarded to the Handling Subcommittee on June 3, 2015. 

The petition was submitted by Botanical Food Company Pty Ltd. hypochlorous acid is being petitioned 

for use in the following areas: 

1. On Farm 

a. As a post-harvest sanitizer for raw herb and spice material <60 ppm 

b. As an equipment and cold room sanitizer <200 ppm 

2. In Processing plants 

a. As a post-harvest, pre-process sanitizer for herbs and spices <200 ppm 

b. As a microbial rinse for herbs and spices <60ppm 

c. As an equipment and room sanitizer <200 ppm 

This petition has been submitted in response to a policy memo issued by the NOP on June 9, 2014: PM 

14-3 Electrolyzed Water (EW). The memo was issued as a response to requests asking for the National 

Organic Program to clarify whether EW was allowed as a sanitizer and antimicrobial agent for use in 

organic production and handling.

The NOP felt that the allowance of EW by a certifier or a material evaluation program were based on an 

incorrect interpretation of the allowance for chlorine materials on the National List of Allowed and 

Prohibited Substances at 7CFR §205.600-606. The NOP requested that certifiers ensure that the use of 

EW was not allowed in organic handling or production and that any party wishing for further 

consideration of EW for use in organic handling or production should submit a petition to get it added to 

the National List. Thus, the rationale for the petition currently before the Handling Subcommittee and 

the full NOSB is in response to the NOP policy memo.

Manufacture and Uses of the Substance:

Hypochlorous acid is produced by electrolysis of a dilute water-sodium chloride solution flowing through 

specialized equipment designed to separate alkaline and acidic products. This electrolytic process 

facilitates the conversion of chloride ions and water molecules into chlorine oxidants (chlorine gas, 

hypochlorous acid, and hypochlorite ion) within the anode chamber and sodium hydroxide in the 

cathode chamber of the production equipment. At an acidic to neutral pH, the predominant chemical 

species is hypochlorous acid (HOCl) with a high oxidation reduction potential (ORP) of ≥1,000 mV. 

Hypochlorous acid has received recent attention as an alternative to other chlorine disinfectants and 

sanitizers. A number of studies have demonstrated the strong antibacterial activity of hypochlorous acid 

against foodborne pathogens on raw agricultural products and food contact surfaces. Applications of 

hypochlorous acid as a disinfectant for reducing microbial contamination have been reported for fresh 

fruits and vegetables, poultry carcasses, shell eggs, cutting boards, and food processing surfaces. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 247/302
According to the TR, some advantages of using hypochlorous acid water are: 1) It is as effective as any 

chlorine treatment; 2) it is not necessary to handle potentially dangerous chemicals, e.g. chlorine gas, 

chlorine dioxide, bleach; 3) the apparatus to produce hypochlorous acid is relatively inexpensive and 

easy to operate; 4) because only water and sodium chloride are used, hypochlorous acid production is 

environmentally friendly; and 5) the properties of the hypochlorous acid can be controlled at the 

preparation site.

Hypochlorous acid can be used as an ingredient in an antimicrobial pesticide formulation and may be 

applied to dairy processing equipment, and food processing equipment and utensils. The Food and Drug 

Administration (FDA) regulations (21 CFR Part 178) permit the use of sanitizing solutions containing 

sodium hypochlorite on food processing equipment and food contact surfaces. In addition to sanitizing 

food contact surfaces, cleaning solutions containing the active ingredient hypochlorous acid may be 

used for sanitizing raw fruits and vegetables during the washing or peeling process. The USDA’s Food 

Safety and Inspection Service Directive 7120.1 “Safe and Suitable Ingredients Used in the Production of 

Meat and Poultry Products”, has approved the use of electrolytically generated hypochlorous acid as a 

food additive for use on meat and poultry products. It is allowed for use on red meat carcasses down to 

a quarter of a carcass, whole or eviscerated poultry carcasses, in water used in meat and poultry 

processing, in poultry chiller water, for reprocessing contaminated poultry carcasses, on giblets and 

salvaged parts, and on beef primal cuts of beef. Depending on the product sanitized from 5 to 50 ppm 

free available chlorine can be used.

Discussion:

From an environmental impact perspective, hypochlorous acid would appear to pose less of a risk for 

the environment than some of the alternatives as it is made from water and salt. There are no byproducts to be disposed of since all of the materials are formulated and used in the final application 

process. Also, it would appear that hypochlorous acid would pose less of a risk to human health and/or 

worker health compared to some of the possible alternative products as well. According to the August 

13, 2015 TR it states that hypochlorous acid at a pH 6.5-7.5 is safer to use that other disinfectants 

containing chlorine. The level of chlorine in hypochlorous acid is usually over ten thousand times less 

than that of common household bleach. The on-site production helps to alleviate the need to transport 

other materials that may be more hazardous to handle, thus reducing the risk of exposure to the worker 

and for possible environmental contamination if improperly handled.

The primary functions of hypochlorous acid are as an anti-microbial, sporicidal, and bactericidal agent.

Some currently allowed alternatives to hypochlorous acid are: Sodium and/or calcium hypochlorite 

(bleach), isopropanol, chlorine dioxide, peracetic/peroxyacetic acid, citric acid, acetic acid, ascorbic acid, 

vinegar are some of the materials currently allowed for use.

Electrolyzed water, although produced via a different mechanism, has the same mode of action as 

sodium and calcium hypochlorite (both of these materials are currently on the National List). In fact, the 

main active ingredient in their dilute aqueous solution form is hypochlorous acid, the same material 

produced as the anolyte component of electrolyzed water.

During the public comment period prior to the fall 2014 NOSB meeting there were several public 

comments submitted in response to the NOP’s decision to halt the allowed use of hypochlorous acid per 

their memo PM 14-3 sent out on June 9, 2014. One of those organic stakeholders provided written 

public comment on September 28, 2014 that included multiple peer-reviewed scientific journal articles. 

These articles provided support to the claim that electrolyzed water was a safe sanitizer, providing the 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 248/302
same degree of anti-microbial control without the toxic risk to employees, the crops, or the harvested 

products it is applied to. 

This material does look like it could provide organic handling operations a material that has strong 

antimicrobial properties and is more compatible with the fundamental principles of organic production. 

Evaluation Criteria 

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

Subcommittee Action & Vote

Classification Motion: Move to classify hypochlorous acid as synthetic. 

Motion by: Ashley Swaffar 

Seconded by: Jean Richardson 

Yes: 6 No: 0 Abstain: 0 Absent: 2 Recuse: 0 

Listing Motion: Move to list hypochlorous acid at §205.605(b), chlorine materials. 

Motion by: Ashley Swaffar 

Seconded by: Jean Richardson

Yes: 6 No: 0 Abstain: 0 Absent: 2 Recuse: 0 

 

Approved by Harold V. Austin IV, Handling Subcommittee Chair, to transmit to NOSB February 16, 

2016

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 249/302
NOSB Evaluation Criteria for Substances Added To the National List - Handling

Category 1. Adverse impacts on humans or the environment? Hypochlorous acid

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

x According to the petition electrolyzed water 

can be made on-site. In this process there 

would not be any residual product to dispose 

of. If produced off-site and sold as a finished 

product then there could be a possibility of 

environmental contamination as the result of 

an accident or a spill. The TR does state that 

in forms of hypochlorous acid that are at a 

pH<4.0, dissolved chlorine gas can be rapidly 

lost due to volatilization, decreasing the 

biocidal effectiveness of the solution over 

time, but also creating possible human 

health and safety issues (Fisher, 2009). The 

more neutral, the pH of the material, the 

safer and more stable the substance appears 

to become.

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

x This substance is formed by the electrolysis 

of a sodium chloride solution. Any 

environmental concerns would be from a 

spill during manufacturing or transport of a 

formulated end product.

3. Are there any adverse impacts on 

biodiversity? (§205.200)

x The TR, (lines 596-612) does state that 

hypochlorous acid in aqueous solutions at 

pH< 7 was of minimal toxicity to birds, but 

could be very toxic to fish and freshwater 

invertebrates. 

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

x Contaminants listed in the US Food and Drug 

Administration’s Guidance for Industry: 

Action Levels for Poisonous or Deleterious 

Substances in Human Food and Animal Feed, 

are unlikely to be found in hypochlorous acid 

since it is the electrolysis product of two 

generally recognized as safe materials, salt 

and water (TR lines 568-571).

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

x The TR (lines 140-153) mentions that there 

can be a reaction with organic material 

(humic acid) which can lead to some 

potential concerns. It does go onto state 

though: It is generally accepted that 

carcinogenic and teratogenic 

trihalomethanes and haloacetic acids are not 

formed by the action of hypochlorous acid in 

neutral or near-neutral solutions (Satyawli et 

al., 2007). 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 250/302
6. Is there a toxic or other adverse action of the 

material or its breakdown products?

[§6518(m)(2)]

x

7. Is there persistence or concentration of the 

material or breakdown products in the 

environment? [§6518(m)(2)]

x According to the TR (lines 602-612) 

hypochlorous acid solution decomposes very 

slowly in the dark but more rapidly in the 

presence of light, rapidly in full sun light by 

producing hydrogen chloride and oxygen. 

Released into the environment it is 

distributed into water and air, with an 

estimated half-life of 1-4 hours. A potential 

for bioaccumulation or bioconcentration of 

active chlorine species can be disregarded, 

because of their water solubility and their 

high reactivity.

8. Would the use of the substance be harmful 

to human health or the environment? 

[§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]

x Information provided in the petition states 

that compared to other types of chlorine, 

electrolyzed water is usually used at an 

active rate that is ten thousand times less 

than that of common household bleach. The 

TR (lines 624-626) mentions that the human 

innate immune system uses hypochlorous 

acid to fight infection but also directs it 

against host tissue in inflammatory diseases 

(Kettle et al.,2013). Chlorine disinfectants 

have been shown to cause occupational 

dermatitis or skin irritation (TR line 662).

9. Are there adverse biological and chemical 

interactions in the agro-ecosystem? 

[§6518(m)(5)]

x See the answer to question #5 above.

10. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518(m)(5)]

x

Category 2. Is the Substance Essential for Organic Production? Hypochlorous acid

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] x

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

x Electrolyzed water is the product of the 

electrolysis of a dilute sodium chloride 

solution in an electrolysis cell containing a 

semi-permeable membrane. This process 

creates hypochlorous acid, hypochlorite ion, 

and hydrochlorite at the anode and sodium 

hydroxide at the cathode. (TR lines 48-68) 

August 13, 2015 TR.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 251/302
3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

x

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

x

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

x

6. Is there an organic substitute? 

[§205.600(b)(1)]

x Organic acids such as citric acid, lactic acid, 

malic acid, and vinegar are some alternative 

materials. 

7. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

x Hot water can be used in some instances. 

8. Are there any alternative substances? 

[§6518(m)(6)]

x Some alternative substances are: Sodium 

and/or calcium hypochlorite (bleach), 

isopropanol, chlorine dioxide, peroxyacetic 

acid, citric acid, acetic acid, ascorbic acid, and 

vinegar. Copper sulfate is another possible 

alternative depending on the use. 

9. Are there other practices that would make 

the substance unnecessary? [§6518(m)(6)]

x

Category 3. Is the substance compatible with organic production practices? Hypochlorous acid 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

x Compared to many of the alternative 

materials currently being used electrolyzed 

water could provide a safer and effective 

alternative. (especially when produced using 

the on-site electrolysis process)

2. Is the substance compatible with a system of 

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

x See answer to question #1 of this category.

3. If used in livestock feed or pet food, is the 

nutritional quality of the food maintained 

with the substance? [§205.600(b)(3)]

x

4. If used in livestock feed or pet food, is the 

primary use as a preservative? 

[§205.600(b)(4)]

x

5. If used in livestock feed or pet food, is the 

primary use to recreate or improve flavors, 

colors, textures, or nutritive value lost in 

processing (except when required by law)? 

[§205.600(b)(4)]

x

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 252/302
6. 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

x

toxins derived from bacteria x

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

x

livestock parasiticides and medicines x

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

x May be used to sanitize equipment

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 254/302
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal - Sodium Dodecylbenzene Sulfonate

January 23, 2016

Background 

On October 9, 2015 the NOP received a petition to add Sodium Dodecylbenzene Sulfonate (SDBS) (CAS # 

25155-30-0) to the National List at §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) Synthetics Allowed. This petition was forwarded to the Handling 

Subcommittee on November 2, 2015 for the appropriate petitioned material process to be conducted.

The petition was submitted by Ecolab, Inc. Sodium dodecylbenzene sulfonate is being petitioned for use 

as an active ingredient (1 of 2 active ingredients, the other is lactic acid) in an antimicrobial formulation, 

for use in treating fruits and vegetables in the premises of organic food retail establishments. The Ecolab 

antimicrobial material is: AFVT-Antimicrobial Fruit & Vegetable Treatment. 

The petitioner does not manufacture SDBS, but uses it as 1 of 2 active ingredients in their product 

(AFVT) formulation. They listed 3 companies that SDBS is manufactured by:

1. Pilot Chemical Company – Santa Fe Springs, CA. 

2. Stepan Company – Northfield, IL.

3. Unger Fabrikker A.S. – Fredrikstad, Norway

Sodium dodecylbenzene sulfonate is currently used (an anionic surfactant) in industrial, institutional, 

chemical detergents & cleaners, specialty cleaners, sanitization products, emulsifiers, suspension or 

wetting agents, absorbents in pesticide and other agricultural chemicals, along with numerous other 

uses. (Toxnet 2014).

Manufacturing

There are several ways to manufacture Sodium dodecylbenzene sulfonate. The primary source is to start 

with LAS (Linear alkybenzene sulfonate) which is made by the sulfonation of alkylbenzenes prepared 

from petroleum distillates. In one of the most common processes benzene is alkylated by long chain 

monoalkenes (e.g. dodecene) using hydrogen fluoride as a catalyst. The purified dodecylbenzenes (and 

related derivatives) then form dodecylbenzene sulfonic acid, which is then subsequently neutralized 

with sodium hydroxide (Kurt Kosswig, “Surfactants in Ullman’s Encyclopedia of Industrial Chemistry, 

Wiley-VCH, 2005). The final slurry can then be dried by either drum drying (this forms flakes or powder) 

or by using a spray drier system, (this forms beads) to create the desired form of Sodium 

dodecylbenzene sulfonate.

According to information provided in the petition, the sulfonation technology has been considerably 

improved, with the most modern systems beginning to use falling film reactors (FFR) (mono-tube or 

multi-tube) and SOɜ, found in many sulfonation facilities in Europe. Also mentioned in the petition: in 

the mid 90’s there was a new form of alkylation technology introduced that is now being used in Europe, 

based on heterogeneous catalyst in a fixed-bed reactor. This new technology offers: process 

simplification, elimination of acids handling and disposal (HF, HCI) as well as an overall production yield 

improvement and improved LAB quality.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 255/302
Discussion

The petitioner (Ecolab, Inc.) is trying to get SDBS added to the National List as a processing aid, so that it 

may be used as one of two active ingredients in their antimicrobial product. This product (Ecolab’s 

Antimicrobial Fruit and Vegetable Treatment) specifically formulated for use in food retail environments 

such as restaurants, cafeterias, food service operations, commissaries and kitchens. They state that it 

would help to provide the organic users a new reliable tool to aid in the battle against microorganisms 

that cause food borne illness outbreaks. The petitioner further states that when SDBS is used as one of 

two active ingredients in their formulated product it is very effective in helping to control pathogens 

(Escherchia coli O157:H7, Listeria monocytogenes, and Salmonella enterica) when used in wash water or 

on surfaces of raw or processed fruits and vegetables.

The petitioner states that in the mode of action there are three mechanisms that SDBS works by 

providing. These are: Protein denaturing; essential enzyme inactivation; and by membrane disruption 

and alteration of cell permeability.

SDBS has been cleared for use as an antimicrobial agent in produce wash water by the Food and Drug 

Administration (FDA) under 21CFR 173.405. But, it is not listed as GRAS.

Sodium dodecylbenzene sulfonate does not appear to pose any serious human health or environmental 

concerns under the proposed use pattern. But, according to the New Jersey Department of Health and 

Senior Services Hazardous Substance Fact Sheet (revised May, 2002) and the MSDS for SDBS, it can be a 

skin irritant, could possibly cause eye damage, and if inhaled be an irritant of the nose, throat, and 

lungs. This same fact sheet also states that repeated exposure could cause bronchitis to develop. SDBS 

according to the Material Data Sheet is listed as: DOT: UN3077, Rq, Environmentally Hazardous 

Substance, Solid, N.O.S. (Sodium Dodecylbenzene Sulfonate), 9, III, Marine Pollutant (Linear 

Alkylbenzene Sulfonate). Also, it has been noted that SDBS is slightly toxic to Bobwhite quail and green 

algae and moderately toxic to some species of fish.

Information provided in the EPA 2006 Registration Eligibility Document (RED) states: No environmental 

exposure is expected to occur from the majority of linear alkylbenzene sulfonate uses and it is unlikely 

that any appreciable exposure to terrestrial or aquatic organisms would occur from limited commercial 

down-the-drain use because of the very small number of pounds for these uses plus their rapid 

degradation in the environment.

There is one area of possible concern regarding SDBS and its use and compatibility with organic crop 

production in that according to one report (Estrin et al. 1982), it states that SDBS contains impurities 

that could include: neutral oil (unsulfonated materials), arsenic (As), iron (Fe), and possibly lead (Pb). 

The levels of these impurities, was not defined. It is not clear if the new methods of formulation 

mentioned in the petition further remove any of these impurities or not.

There currently are alternative materials in use by organic handlers which would include: lactic acid, 

citric acid, acidified sodium chlorite, and peracetic acid. The petitioner states that while these materials 

are available for use by organic handlers and retailers, that SDBS would enable the petitioner to provide 

a formulated product for use at the food retail, kitchen, restaurant level, etc. where there currently is 

not such a product available. It is their position that the other available materials are normally used at 

the processing level and not necessarily at the food retail levels for raw and ready to eat fruits and 

vegetables.

It would help the full committee during their deliberation of this material if organic stakeholders could 

provide us with the following information:

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 256/302
• What are retailers currently using to address these concerns?

• Are any of the alternatives mentioned in the petition currently used at the retail level and if so are 

 they effective in addressing these areas of food safety concerns? 

• What are the level (if any) of impurities as mentioned in this document found in SDBS?

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes ☒ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No ☒ N/A 

as Organic (only for §205.606)

Substance Fails Criteria Category: [2] Comments: Alternatives available

Subcommittee Action & Vote

Classification Motion: Move to classify sodium dodecylbenzene sulfonate as synthetic. 

Motion by: Harold V. Austin IV 

Seconded by: Ashley Swaffar 

Yes: 7 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

Listing Motion: Move to list sodium dodecylbenzene sulfonate at §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))” of the National List.

Motion by: Harold V. Austin IV 

Seconded by: Tom Chapman 

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

 

Approved by Harold Austin, Handling Subcommittee Chair, to transmit to NOSB February 23, 2016

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 257/302
NOSB Evaluation Criteria for Substances Added To the National List – Handling

Category 1. Adverse impacts on humans or the environment? Sodium dodecylbenzene sulfonate (SDBS) 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use or 

misuse of the substance?

[§205.600(b)(2), [§6518(m)(3)] 

X Information provided in the EPA 2006 

Registration Eligibility Document (RED) 

states: No environmental exposure is 

expected to occur from the majority of linear 

alkylbenzene sulfonate uses and it is unlikely 

that any appreciable exposure to terrestrial 

or aquatic organisms would occur from 

limited commercial down-the-drain use 

because of the very small number of pounds 

for these uses plus their rapid degradation in 

the environment.

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the substance?

[§6518(m)(3)]

See answer to question 5 below.

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X

5. Is there undesirable persistence or 

concentration of the material or breakdown 

products in the environment? [§6518(m)(2)] 

X It is biodegraded rapidly under aerobic 

conditions with a half-life of approximately 1-

3 weeks; oxidative degradation initiating at 

the alkly chain. Under anaerobic conditions it 

degrades very slowly or not at all, causing it 

to exist in high concentrations in sewage 

sludge. This is thought to not be of a concern 

as it will rapidly degrade once returned to an 

oxygenated environment. (Jenson, John 

February 1999, “Fate and effects of linear 

alklybenzene sulfonates (LAS) in the 

terrestrial environment”).

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added to it? 

[§6517(c))(1)(A)(i); 6517 (c)(2)(A)(i); 

§6518(m)(4), 205.600(b)(3)] 

X According to the New Jersey Department of 

Health and Senior Services Hazardous 

Substance Fact Sheet (revised May, 2002) 

and the MSDS for this material, it can be a 

skin irritant, could possibly cause eye 

damage, and if inhaled can be an irritant to 

the nose, throat, and lungs. Repeated 

exposure could cause bronchitis to develop, 

according to the N.J. Dept.of Health Fact 

Sheet.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 258/302
7. Is the substance, and any ancillary 

substances, GRAS when used according to 

FDA’s good manufacturing practices? 

[§205.600(b)(5)]

X

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 (b)(5)]

X SDBS contains impurities that include neutral 

oil (unsulfonated materials), arsenic (As), iron 

(Fe), and lead (Pb). (Estrin et al.1982). The 

level of these impurities was not defined. It is 

not clear if the new methods for formulating 

SDBS (as stated in the petition) further 

remove any of these impurities or not.

Category 2. Is the Substance Essential for Organic Production? Sodium dodecylbenzene sulfonate (SDBS)

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X There are multiple ways to manufacture 

SDBS: One process is by reacting 

dodecylbenzene with sulfuric acid (Oleum 

Process) or air/SO2 to produce 

dodecylbenzene acid (CTFA 1991a). The 

dodecylbenzene sulfonic acid is then 

neutralized with sodium hydroxide. 

The most common process is: Benzene is 

alkylated by long chain monoalkenes (e.g. 

dodecene) using hydrogen fluoride as a 

catalyst. The purified dodecylbenzenes (and 

related derivatives) then form 

dodecylbenzene sulfonic acid, which is then 

subsequently neutralized with sodium 

hydroxide (Kurt Kosswig, “Surfactants in 

Ullman’s Encyclopedia of Industrial 

Chemistry, Wiley-VCH, 2005). The final slurry 

can then be dried by either drum drying (this 

forms flakes or powder) or by using a spray 

drier system (this forms beads).

According to information provided in the 

petition the sulfonation technology has been 

considerably improved, with the modern 

systems beginning to use falling film reactors 

(FFR) (mono-tube or multi-tube) and SOɜ, in 

many of the sulfonation facilities in Europe. 

Also mentioned in the petition: in the mid 

90’s there was a new form of alkylation 

technology introduced that is now being 

used in Europe, based on heterogeneous 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 259/302
catalyst in a fixed-bed reactor. This new 

technology offers: process simplification, 

elimination of acids handling and disposal 

(HF, HCI) as well as an overall production 

yield improvement and improved LAB 

quality.

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

X

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X According to information provided by the 

petition citric or lactic acid could serve as 

possibly substitutes (For the AFVT product’s 

intended use).

7. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600(b)(6)]

X

8. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

X According to information provided by the 

petition either citric or lactic acid could 

possibly be used as a substitute for this 

material for microbial control.

9. Are there any alternative substances? 

[§6518(m)(6)] 

X Yes for the overall intended use of the 

material (when used in the finished product 

that the petitioner is requesting this material 

be added to the National List so it can be 

used as one of two active ingredients in), 

then acidified sodium chlorite or peracetic 

acid could be used instead. But they do 

mention that these materials are more apt to 

be used in commercial food processing 

establishments and not in restaurants, 

kitchens, etc. as is the intended area of use 

proposed by the AFVT product label.

10. Is there another practice (in farming or 

handling) that would make the substance 

unnecessary? [§6518(m)(6)]

X Current processes in place utilizing materials 

already allowed for use in organic handling 

and processing.

11. Have the ancillary substances associated 

with the primary substance been reviewed? 

Describe, along with any proposed 

limitations. 

X

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 260/302
NOSB Evaluation Criteria for Substances Added To the National List - Handling

Category 3. Is the substance compatible with organic handling practices? Sodium dodecylbenzene 

Sulfonate (SDBS)

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

handling? [§6517(c)(1)(A)(iii); 

6517(c)(2)(A)(ii)]

X

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible with 

organic handling? [§205.600(b)(2)]

X

3. Is the substance compatible with a system of 

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

X

4. Are the ancillary substances reviewed 

compatible with organic handling [?

X none

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

X

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law)? [§205.600(b)(4)]

X

Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially unavailable? 

[§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Sodium Dodecylbenzene Sulfonate 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the comparative description as to why the 

non-organic form of the material /substance 

is necessary for use in organic handling

provided? 

X

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling? 

X

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling? 

X

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 261/302
4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

X

5. Does the industry information about 

unavailability include (but is not limited to) 

the following?: 

a. Regions of production (including factors 

such as climate and number of regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

X

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

X

e. Other issues which may present a 

challenge to a consistent supply?

X

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 262/302
National Organic Standards Board

Handling Subcommittee

Ancillary Substances Procedure - Proposal

February 16, 2016

Background

Ancillary substances have been discussed by the NOSB for several years now, with an overall policy 

being passed in 2014 and ancillaries being looked at in Technical Reports (TR) and NOSB reviews since 

then. 

However, attempts to pass a separate ancillary substance proposal to accompany the review of specific 

National List entries have all been withdrawn by the board due to issues brought up by the public during 

the comment period. So far these have included ancillaries in microorganisms (brought forward 3 

times), pectin, and yeast. Additional listings from the National List were recently renewed in the Sunset 

2017 process that also have ancillary substances, including enzymes and nutrient vitamins and minerals. 

While ancillaries were covered in the TRs for these, it was decided not to bring forward proposals until 

the previous ones were approved and a standard format could be established.

Discussion

The main issues raised in public comment have been examined by the Handling Subcommittee (HS) and 

are as follows:

• Accredited Certifying Agents (ACA) would have to do a lot more paperwork to verify ancillary 

substances by functional class. Right now most specification sheets may list names of ancillaries 

but not specify the functional class each one is in.

• While the charts presented of the known ancillary substances are helpful, there is no clear 

procedure for ACAs to evaluate those that are not on the chart.

• Allowing other ancillaries that are not on the chart could result in some very problematic 

substances being allowed, specifically preservatives.

• A separate proposal and vote is not necessarily needed for those ancillaries that are allowed, 

but is needed for any that the NOSB wishes to prohibit.

• All ancillary substances should be reviewed separately and added to the National List. (This was

rejected by the NOSB in the 2014 recommendation but it still keeps coming back in public 

comment).

In light of some of these issues, the HS has decided to propose an additional set of criteria and 

procedures for ACAs and suppliers of ingredients so that it is clear what tools everyone can use for 

compliance with the 2014 recommendation. If these are adopted and followed, there will not be a need 

for a separate ancillary substance proposal for each listing on the National List. 

The proposal includes:

1. A definition of Ancillary Substance

2. Criteria used to review ancillary substances that can be used by both the NOSB in initial review 

and ACAs in subsequent verifications.

3. Procedures for the NOSB to follow for those materials that may have ancillary substances to be 

reviewed.

4. (optional) Example of a standardized template for ACAs to determine compliance.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 263/302
Proposal

1. Definition

Ancillary Substance: Additives intentionally added to a non-organic substance on the National List 

that are not removed and have a technical or functional effect on the non-organic substance, not on 

the final organic product that the non-organic substance is used in. Ancillary substances may be 

present in the final organic product but only in insignificant amounts. Ancillary substances fall under 

the FDA definition and labeling regulations for “incidental additives,” which do not need to be 

declared on the label of the final food (including organic product) (CFR Title 21 101.22(h)(3) and 

101.100 (a)(3 i to iii4). To illustrate: Enzymes are listed on 205.605(a). The enzymes might contain 

the following additives, which are considered by the organic industry as “ancillary ingredients”: 

calcium silicate (anticaking agent), calcium phosphate (carrier and/or filler), stearic acid 

(preservative), sorbitol (stabilizer), sodium citrate (pH control, buffer). 

2. Criteria for Compliance

At least one must apply:

1. The ancillary ingredient was considered part of the manufacturing process that has already 

been reviewed by the NOSB. 

2. The ancillary ingredient is certified organic, on the National List 205.605 or 205.606, or is 

agricultural (e.g., sugars as standardizing agents in pectin).

3. The ancillary ingredient is approved by FDA as GRAS for the particular use. 

4. The ancillary ingredient is approved by FDA as a direct food additive or incidental additive 

for the particular use.

5. The ancillary ingredient is approved by FDA as a food contact substance for the particular 

use, as evidenced by a Food Contact Notification (FCN).

Additionally, the ancillary ingredient cannot be a known or probable carcinogen according to the 

International Agency for Research on Cancer (IARC) or the National Toxicity Program (NTP). A compiled 

list is published by the American Cancer Society 

at http://www.cancer.org/cancer/cancercauses/othercarcinogens/generalinformationaboutcarcinogens

/known-and-probable-human-carcinogens

Examples of ancillaries that are listed on the IARC and/or NTP list, and would therefore be prohibited, 

include formaldehyde and butylated hydroxyanisole (BHA)

3. Procedure for NOSB review of ancillaries

The first three of these procedures are already in place, but the last ones are different from the past 

approach.

• At the time of requesting a TR for a new or sunset substance, the NOSB will ask that information 

about identity and functional classes of ancillary substances be reviewed along with the other 

evaluation questions.

• For new substances, a chart of the ancillary substances by functional class will be incorporated 

in the checklist document or whatever review template is used.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 264/302
• For sunset substances, a chart of the ancillary substances by functional class will be included in 

the first posting along with a request for new information about existing ancillaries and/or 

additional ancillary substances to be brought forward in public comment.

• The vote to approve a new substance will be considered to also approve the ancillaries that are 

associated with that substance unless the NOSB specifically states that one is not approved. 

Similarly, the vote to finalize the sunset review after the second posting will be considered to 

also approve ancillaries unless one is pulled out as not approved.

• Any ancillary substances that the NOSB wishes to prohibit (that are not already on the IARC and 

NTP lists) will have to come before the board in a separate proposal that can be voted on at the 

same meeting or a subsequent meeting of the board.

4. Example of Information for an Ancillary Substances Compliance Template.

For ancillary substances that are already on the list of those reviewed by the NOSB, another form may 

not be needed. But for new ancillary substances, and if ACAs wish to develop a compliance template, 

the following information should be included on the template:

1. Definition of ancillary ingredients (see 1 above)

2. A request for the name of the non-organic ingredient that the ancillary ingredient is in (e.g., 

pectin)

3. A request for the name of the ancillary ingredients in the product and CAS #’s (e.g., dextrose, 

CAS#: 50-99-7)

4. The Criteria for Compliance (see 2 above)

5. A request for the justification that ancillary ingredients meet the criteria (e.g., the FDA 

regulatory reference and confirmation that the ancillary is not a known or probable carcinogen 

according to the International Agency for Research on Cancer (IARC) or the National Toxicity 

Program (NTP)).

6. A request for a specification sheet with full ingredient disclosure for the non-organic ingredient 

(e.g., a specification sheet with full ingredient disclosure listing pectin and also the dextrose, 

which is used as a standardizing agent).

7. A request for the name, signature and date of the party signing the compliance declaration. 

8. Language that speaks to the legal ramifications of falsifying information to ACAs.

Note: All requested information is required to be completed by the responsible party in order for the 

compliance declaration to be accepted by the ACA. 

Motion to adopt the proposal as stated above for the definition, criteria for compliance, and procedure 

for the review of ancillary substances.

Motion by: Zea Sonnabend

Seconded by: Jean Richardson

Yes: 6 No: 0 Abstain: 0 Absent: 2 Recuse: 0

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 265/302
NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 266/302
National Organic Standards Board

Handling Subcommittee

Nutrient Vitamins and Minerals §205.605(b) Annotation Change - Discussion Document

February 23, 2016

Introduction

The Handling Subcommittee would like to change the annotation for the listing for Nutrient Vitamins and 

Minerals. It has been acknowledged that it needs to change since the Federal Rule first came out, but 

there have been mixed opinions on how to change it. This Discussion Document covers the background on 

the issue and presents several options for changes to the annotation. Members of the Handling 

Subcommittee are not unanimous on any of these options but wish to explain them and solicit public 

input on the pros and cons of them.

Background and Relevant Areas of the Rule

Reference: §205.605(b) Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional 

Quality Guidelines For Foods. 

Technical Report: 1995 TAP - Minerals; 1995 TAP - Vitamins; Technical Report (2015) (PDF)

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2011 

Handling Subcommittee Proposal; 04/2011 sunset recommendation, 10/2015 sunset review

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

Proposed Rule published 01/12 2012 (77 FR 1980), Sunset Review 2012, Interim rule published 

09/27/2012 (77 FR 59287). 

Sunset Date: 10/21/2017

Brief History of this issue

• In 1995 the NOSB added nutrient vitamins and minerals to the National List with the following 

annotation, ‘‘Accepted for use in organic foods for enrichment or fortification when required by 

regulation or recommended by an independent professional organization.’’1 A second 

recommendation was also passed entitled ‘‘Final Recommendation Addendum Number 13, The 

Use of Nutrient Supplementation in Organic Food.’’ This stated, ‘‘Upon implementation of the 

National Organic Program (NOP), the use of synthetic vitamins, minerals, and/or accessory 

nutrients in products labeled as organic must be limited to that which is required by regulation or 

recommended for enrichment and fortification by independent professional associations.’’

• The final rule that was published in 2000 (65 FR 13512) came out with the current annotation. It 

was recognized soon after that the cross reference to the FDA’s fortification policy for food at 21 

CFR 104.20 was not accurate and that a correction to the current listing is necessary.2

The existing annotation is not what the original NOSB recommended in 1995. In 2011, the Handling 

Subcommittee proposed to change the annotation at sunset but received approximately 2000 comments 

against it due to concerns about broadening the scope. The Subcommittee withdrew the proposal prior to 

1 NOSB, 1995. Final Minutes of the National Organic Standards Board Full Board Meeting Austin, Texas, October 31–

November 4, 1995, available at: 

https://www.ams.usda.gov/sites/default/files/media/NOSB%20Meeting%20Minutes%26Transcripts%201992-2009.pdf 2 77 FR 1980 – NOP proposed rule from 2012.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 267/302
the April 2011 NOSB meeting and the NOSB supported relisting with existing annotation for the 2012 

sunset review.

• In 2007 the NOP provided an interpretation of the regulation that mistakenly concluded that 21 

CFR 104.20 allowed a wide variety of nutrients that were not limited to just vitamin and minerals.

In 2010 the NOP met with the FDA to clarify the meaning of the FDA guidance at 21 CFR 104.20. 

The NOP issued a memo to the NOSB in April 2010 explaining this clarification. 

• On January 12, 2012 a proposed rule was published in the Federal Register (77 FR 1980) to 

change the annotation to: 

§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed 

products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food 

groups(s)).’’ 

(b) Synthetics allowed

Vitamins and minerals. For food— vitamins and minerals identified as essential in 21 CFR 

101.9. For infant formula—vitamins and minerals as required by 21 CFR 107.100 or § 107.10.3

• This clarified that the "nutrients" that were not on these CFR sections had to be petitioned 

individually for the National List because this listing did not cover them.

• NOP did not finalize the proposed rule, but on September 27, 2012 published an Interim Rule (77 

FR 59287), which renewed without change the original listing, as per the NOSB April 2011

recommendation.

• In 2011 through 2013 many such items were petitioned. A few were recommended to be listed 

by the NOSB and most were not. No rulemaking has happened to add the recommended 

substances or clarify the current reference, so the prohibited ones are still in use and the 

recommended ones have not been added to the National List.

• In 2014 the Handling Subcommittee commissioned a new Technical Report in preparation for 

Sunset 2017 reviews. This was completed in February 2015. It clarifies a lot about which 

substances are required and permitted and which are covered by the 21 CFR citations or other 

regulations.

• Both the TR and the proposed rule are required reading to understand this issue.

Discussion

All members of the Handling Subcommittee agree that the proposed language in the 2012 proposed rule 

would change the title of the listing from "Nutrient Vitamins and Minerals" to " Vitamins and minerals. For 

food" is a preferred choice. Some believe in limiting the category further than what was proposed and 

some do not. In addition, the Handling Subcommittee believes that the past decisions of the NOSB 

regarding petitioned nutrients for infant formula needs to be acted upon by the NOP as soon as possible.

Option 1 for discussion:

Some members of the Handling Subcommittee believe that the original intent of the NOSB is what should 

form the backbone of the listing and annotation for Vitamins of Minerals and, to achieve this, they have 

proposed three related annotations. 

Proposed Annotation #1: §205.605 (b) Vitamins and minerals, synthetic. For food – Minerals 

(including trace elements), vitamins and similar isolated ingredients are allowed only when 

3 77 FR 1980 – NOP proposed rule from 2012.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 268/302
their use is required by law or to meet an FDA standard of identity in which they are 

incorporated.

 This has a lot of advantages:

• It is in alignment with all other international organic standards (and what we have now is not).

• (from the proposed rule 2012): 1. The authority citation for 7 CFR part 205 continues to read as 

follows: Authority: 7 U.S.C. 6501–6522. 2. Section 205.605(b) is amended by: A. Removing the 

listing for ‘‘Nutrient vitamins and minerals’’. B. Adding a listing for ‘‘Vitamins and minerals’’. 

• With new information from the FDA and the Technical Report we can now spell out which exact 

fortifications and enrichments are required by law. They are: 

Standards of Identity in Title 21 CFR that require Nutrient Fortification 4

Food class Regulation Specific vitamins or minerals required by 

FDA

Infant formula 21 CFR 107.100

21 CFR 107.10

All nutrients known to be essential and listed 

therein

Margarine 21 CFR 166.110 Vitamin A

Milk 21 CFR Part 131 Vitamins A & D (required by some states)

Examples of other specific regulations include the following:

Food class Regulation Specific vitamins or minerals 

Milk for Women, Infant and 

Children (WIC) program

7 CFR 246.10 Vitamins A & D

Soy-based beverage (milk 

alternative) for WIC

7 CFR 246.10 Vitamins A & D, calcium, magnesium, 

phosphorus, riboflavin, vitamin B12

Fruit juice for WIC 7 CFR 246.10 Vitamin C

Infant cereals (WIC) 7 CFR 246.10 Iron

Adult cereals (WIC) 7 CFR 246.10 Iron

There are many products out there that are currently fortified with synthetic vitamins and minerals that 

are not required to be. Consumers have repeatedly stated that they do not want synthetic ingredients in 

their organic food and that they should have the right to make informed decisions about their food 

choices. Nutrient supplementation is one of those choices that some consumers may choose but others 

would like to avoid. Therefore we propose a second annotation:

Proposed Annotation #2: §205.605 (b) Vitamins and minerals, synthetic. For food – Minerals 

(including trace elements) and vitamins identified as essential in 21 CFR 101.9. For infant formula—

vitamins and minerals as required by 21 CFR 107.100 or § 107.10 are allowed for use in agricultural 

products labeled “made with organic (specified ingredients or food group(s)),” prohibited in 

agricultural products labeled “organic” (except as noted in annotation #1).

• Some Handling Subcommittee members' hold the opinion that this is exactly why the "Made with 

organic" category was written into the rule. It enables products to be made with organic 

agricultural ingredients, but still have desirable synthetic ingredients added to them.

4 Excerpted from 2015 TR, Nutrient Vitamins and Minerals 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 269/302
• This lessens the economic burden for companies who would not have to re-formulate entirely, 

but only have to change their label to a Made with Organic claim.

• Consumers can easily understand this, contrary to some industry claims.

These two annotations would set the course straight for limiting synthetic vitamins and minerals in 

organic foods but there is one loose end from these changes. The recent TR points out that many of the 

Vitamins in use are made from fermentation processes and could be determined to be nonsynthetic. It 

also points out that biotechnology is being increasingly used in the production of some vitamins. See 

Evaluation Question #1 from the 2015 TR (lines 425- 459). Since we believe that the public's concern is 

primarily with synthetic vitamins and minerals, we suggest that the nonsynthetic forms should continue 

to be allowed, but this means placing them on §205.605(a). ACA's would have to determine which forms 

meet a nonsynthetic allowance, but the TR refers primarily to Vitamins D2, B2, B12, E, F, K, and C.

Proposed Annotation #3: §205.605 (a) Vitamins and minerals, non-synthetic. For food – 

Minerals (including trace elements) and vitamins identified as essential in 21 CFR 101.9. For 

infant formula—vitamins and minerals as required by 21 CFR 107.100 or § 107.10 are allowed 

for use in agricultural products labeled Organic.

Option 2 for discussion:

Some members of the Handling Subcommittee believe that the language in the 2012 proposed rule 

should be adopted for both the Organic and Made with Organic Categories of products.

Proposed Annotation #4: §205.605 (b) Vitamins and minerals, synthetic. For food – Minerals 

(including trace elements) and vitamins identified as essential in 21 CFR 101.9. For infant formula—

vitamins and minerals as required by 21 CFR 107.100 or § 107.10 are allowed for use in agricultural 

products labeled "organic" and “made with organic (specified ingredients or food group(s))”.

• This removes the old incorrect 21 CFR citation and substitutes the correct ones for both adult 

food and infant formula.

• This has the least impact on companies with products that are already supplemented with 

vitamins and minerals.

• Consumers still have a choice to not purchase products with synthetic ingredients because they 

are listed on the label.

Questions for Public Comment:

1. Which of these options do you prefer, and why?

2. Is there another option that should be considered instead of these?

3. Are there mandatory international fortification requirements that should be taken into consideration 

 for products being exported and, if so, how should the annotation be revised?

Subcommittee Vote

Motion to adopt the discussion document on Nutrient Vitamins and Minerals

Motion by: Zea Sonnabend

Second: Harold Austin

Yes: 7 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 270/302
Sunset 2018 Review Summary 

Meeting 1 - Request for Public Comment

Crops Substances

April 2016 

Introduction

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

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

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

National List used in organic crop production that must be reviewed by the NOSB and renewed by the 

USDA before their sunset dates in 2018. This list provides the substance’s current status on the National 

List, use description, references to past technical reports, past NOSB actions, and regulatory history, as 

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

if any new technical report is available, please check for updates under the substance name in 

the Petitioned Substances Database. 

Request for Comments

While the NOSB will not complete its review or recommendations on these substances until the fall 2016 

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

NOSB as part of the spring 2016 public meeting. These comments should be provided through 

www.regulations.gov by April 6, 2016 as explained in the meeting notice published in the Federal 

Register. 

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

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

substances currently on the National List were added to the list based on evidence available to the NOSB 

at the time. The substances were found to be: (1) not harmful to human health or the environment, (2) 

necessary because of the unavailability of wholly nonsynthetic alternatives, and (3) consistent and 

compatible with organic practices. 

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

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

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

or whether the substance is no longer needed or in demand.

Guidance on Submitting Your Comments

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

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

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

For Comments That Support Substances Under Review:

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

provide information demonstrating that the substance is: 

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

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

nonsynthetic substitute products; and 

(3) consistent with organic crop production. 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 271/302
For Comments That Do Not Support Substances Under Review: 

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

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

Specifically, comments that support the removal of a substance from the National List should provide 

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

(1) harmful to human health or the environment; 

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

(3) inconsistent with crop production. 

For Comments Addressing the Availability of Alternatives: 

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

review. Viable alternatives include, but are not limited to:

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

substance; 

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

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

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

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

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

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

Written public comments will be accepted through April 6, 2016 via www.regulations.gov. Comments 

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

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 272/302
Sunset 2018 Review Summary 

Meeting 1 - Request for Public Comment

Crops Substances

April 2016 

Reference: 7 CFR §205.601 Synthetic substances allowed for use in organic crop production.

(Linked below)

Copper sulfate 

Ozone gas

Peracetic acid

EPA List 3 - Inerts of Unknown Toxicity

Reference: 7 CFR §205.602 Nonsynthetic substances prohibited for use in organic crop 

production.

Calcium chloride 

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 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/2013 (78 FR 61154)

Sunset Date: 11/03/2018

Background

Copper sulfate and fixed coppers used for plant disease control (§205.601(i)(2) and §205.601(i)(3)) were 

recently reviewed for Sunset 2017 and the documents were posted regarding the review criteria in 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 273/302
regards to copper. The listings under review now are for copper used in aquatic rice production to 

control algae or tadpole shrimp (§205.601(a)(3) and §205.601(e)(4), respectively). Because the copper 

sulfate is used in aquatic systems the current annotations include specific requirements for application 

rates. 

Additional information requested by NOSB: 

1. Has there been any new information regarding the viability of alternatives to these uses of copper?

2. Have ACAs noticed any increase in baseline soil test values for copper and done anything about it?

Ozone gas 

Reference: 205.601(a)(5) Ozone gas—for use as an irrigation system cleaner only. 

Technical Report: 2002 TAP

Petition(s): 2001

Past NOSB Actions: 09/2002 meeting minutes and vote; 11/2007 recommendation; 12/2011 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/2013 (78 FR 61154)

Sunset Date: 11/03/2018

Background

Ozone was petitioned for use for weed control in crop production. It was suggested that ozone be 

injected through irrigation drip tape under plastic mulch. A subsequent additional request was made for 

use of ozone as an antimicrobial agent to clean irrigation lines. Ozone is a strong oxidant and works by 

oxidizing plant tissue and bacterial membranes.

In the 2002 TAP review, one reviewer objected strongly to use of “a known and problematic air 

pollutant” in organic farming. Two reviewers felt that ozone should be permitted with restrictions.

Ozone was not approved for use in weed control, but was listed for use as an irrigation system cleaner 

in September, 2002. Used as an irrigation cleaner, ozone is much less likely to be released into the 

atmosphere. Used for weed control, ozone could escape into the atmosphere. At sunset in November 

2007, ozone was relisted by a vote of 14 to 0. At sunset in December 2011, ozone was relisted by a vote 

of 13 to 0.

Additional information requested by NOSB: 

The Crops Subcommittee would like to know if ozone is currently in use for irrigation system cleaning. 

The Subcommittee asks certifiers, inspectors, and producers to provide feedback on whether or not 

ozone is listed on organic system plans and used in organic crop production, to help evaluate if it is still 

necessary for ozone to remain on the National List.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 274/302
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 

Petition(s): 2008

Past NOSB Actions: 11/2007 recommendation; 11/2009 annotation change; 12/2011 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 Date: 5/29/2018

Specific Uses of the Substance: Peracetic acid in organic crop production is used to disinfect equipment. 

It can also be used to treat seeds or asexually propagated planting materials as a disinfectant. It can be 

used to disinfect pruning equipment to help prevent the spread of the fire blight bacterium or used in 

one of the hydrogen peroxide formulations for control on the tree canopy of this same disease. 

Peracetic acid is also used in formulations of hydrogen peroxide, allowed at a concentration of no more 

that 6%, for use in organic crop production. (The Handling listing for Peracetic acid, a 2016 Sunset 

Review material, has recently been voted on to re-list its allowed use).

Technical Report: The Crops subcommittee has requested a new Technical Evaluation Report for 

peracetic acid, but it has not yet arrived and thus any additional information that it might provide will be 

in the 2nd posting for this material review (Fall 2016 NOSB meeting).

Discussion: This appears to be a pretty straightforward material: made from and decomposes back to 

acetic acid, oxygen, and water. Peracetic acid is a very strong oxidizing agent. This substance was first 

developed in 1950. Historically it has 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 in 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 recent 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, according to information 

provided by some organic stakeholders during recent public comment periods.

In the December 2, 2011 NOSB recommendation for the 2013 Sunset Review of peracetic acid for the 2 

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:

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 275/302
§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 percent 

limit was changed to a 6 percent 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 has brought 

some slight confusion into this review, so we are going to try and clean up this historic information and 

also seek to get some clarity on what impact, if any, this annotation had on the various stakeholders 

that are involved. 

Additional information requested by NOSB:

1. Can organic crop producers or certifiers provide the full committee with any information 

that can explain why this material (or one of the alternative materials) is a better option for 

use, in organic crop production, for the listed allowed uses?

2. Has anything changed during the current sunset cycle that would make this material no 

longer necessary for its intended uses for organic crop production? If so, please help to 

explain.

3. It would help the NOSB in the review of this material if we could get feedback as to whether 

the current annotation (at a concentration of no more than 6%) presents any unforeseen 

problems for organic stakeholders, certifiers, or for product formulation. Also, could you 

provide input as to whether or not this annotation is even necessary? 

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): NA

Past NOSB Actions: 10/2002 meeting minutes and vote (see pheromones); 11/2007 

recommendation; 05/2012 recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset Review 

10/09/2008 73 FR 59479 Sunset Review 10/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

This listing will be superseded by the annotation change approved by the NOSB for EPA List 4 and List 

inerts (§205.601(m)(1)). The NOSB is continuing the sunset review process for these EPA List 3 inerts in 

case that change cannot be implemented through rulemaking before the 11/03/2018 sunset of EPA List 

3 inerts. 

Additional information requested by NOSB: 

None

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 276/302
Calcium chloride 

Reference: 205.602 - Nonsynthetic substances prohibited for use in organic crop production. 

(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: 2007 TAP

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

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Background

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. Calcium chloride was subsequently petitioned and added to National List 

section 205.602 as a nonsynthetic substance prohibited for use in organic crop production. 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.”

This material has historically not been allowed for direct soil applications due to high chloride and high 

solubility concerns, however a 2015 petition for removal of the prohibition contests these concerns and 

argues the contrary. Natural substitutes including limestone, gypsum, rock phosphate and bone meal 

are unable to supply calcium in sufficient quantities when faced with limited calcium uptake conditions. 

There are currently 20 registered OMRI products and 10 WSDA registered products. 

The Subcommittee has no concerns regarding the continued listing of calcium chloride.

Additional information requested by NOSB: 

None 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 277/302
NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 278/302
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal - Ash from Manure Burning

January 5, 2016 

Summary of Proposed Action:

EnergyWorks BioPower, LLC submitted a petition to revise 7 CFR 205.602(a), Ash from Manure Burning, 

to include the following annotation: “except where the combustion reaction does not involve the use of 

synthetic additives and is controlled to separate and preserve nutrients.” The petition states that 

EnergyWorks, “owns and operates a facility in PA that uses a staged thermochemical reactor to extract 

over 30 tons of minerals from 240 tons of egg-layer poultry manure each day.” The petitioner argues 

that annotation approval will provide the following benefits: will generate renewable electricity; will 

prevent excess nutrients in the environment; and will increase development of similar commercial 

processing facilities throughout the US. 

Poultry manure is sourced from concentrated animal feeding operations (CAFOs), dried to normalize 

moisture content, conveyed to a thermochemical reactor, exposed to heat and oxygen to achieve 

proper conversion of organic material into combustible biogas (where the primary goal of the process is 

denitrification),and mineral ash is removed, cooled, tested and sold.

As referenced above, ash from manure burning is currently listed at §205.602 as a nonsynthetic 

substance prohibited for use in organic production. The petitioner claims that this “NOP prohibition was 

established because burning of manure was seen as being wasteful of nutrients.” They explain their 

petition rationale by 1) “suggest[ing] that extraction of minerals by controlled combustion preserves 

their non-synthetic nature”, 2) “while allowing organic growers to derive increased value from manure 

as a nutrient resource.”

The Subcommittee did not request a TR having determined not to add the annotation to the material 

listing; the continued blanket prohibition aligns with previous board recommendations. All prior board 

recommendations have supported the prohibition of ash from manure burning. At the fall 2015 NOSB 

meeting, the Board renewed the prohibition during the Sunset 2017 material reviews, stating, “ash from 

manure burning was placed on §205.602 based on its incompatibility with organic production; burning 

these materials is not an appropriate method to use to recycle organic wastes.”

The Crops Subcommittee has determined that the annotation amendment fails the OFPA criteria and 

should not be added to the National List.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☐ Yes ☒ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes ☒ No ☐ N/A

3. Compatibility & Consistency ☐ Yes ☒ No ☐ N/A 

Substance Fails Criteria Category: [3] Comments: Ash from manure burning was originally placed on 

§205.602 based on its incompatibility with organic production. Burning removes carbon and nitrogen 

from the final ash product and lessens its soil-building value. Utilizing burning as a method to recycle 

millions of pounds of excess poultry manure inadvertently supports the business of CAFOs by creating 

an organic industry demand for ash. Utilizing ash from manure burning in order to assist CAFOs in their 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 279/302
reduction of environmental and human health contamination is not a compelling argument for 

consideration for addition to the National List. 

Subcommittee Action & Vote

Motion to annotate ash from manure burning at §205.602 - nonsynthetic substances prohibited for 

use in organic crop production - with the following annotation: “except where the combustion 

reaction does not involve the use of synthetic additives and is controlled to separate and preserve 

nutrients.”

Motion by: Carmela Beck

Seconded by: Colehour Bondera 

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

The motion failed, thus the Subcommittee supports retaining the existing prohibition of manure 

ash in organic crop production. 

Approved by Subcommittee Chair, Zea Sonnabend, to transmit to NOSB February 26, 2016

NOSB Evaluation Criteria for Substances Added To the National List - Crops 

Category 1. Adverse impacts on humans or the environment? Ash from Manure Burning: 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X CAFOs contribute to environmental pollution 

and human health issues

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

X

6. Is there a toxic or other adverse action of the 

material or its breakdown products?

[§6518(m)(2)]

X

7. Is there persistence or concentration of the 

material or breakdown products in the 

environment? [§6518(m)(2)]

X

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 280/302
8. Would the use of the substance be harmful 

to human health or the environment? 

[§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]

X Provided 205.203 requirements are met.

9. Are there adverse biological and chemical 

interactions in the agro-ecosystem? 

[§6518(m)(5)]

X

10. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518(m)(5)]

X

Category 2. Is the Substance Essential for Organic Production? 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X Egg-layer poultry manure

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Manufactured using a thermo-chemical 

reactor exposed to heat and oxygen to 

achieve proper conversion of organic 

material into combustible biogas (where the 

primary goal of the process is denitrification), 

mineral ash is removed, cooled, tested and 

sold.

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

X

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

X

8. Are there any alternative substances? 

[§6518(m)(6)]

X

9. Are there other practices that would make 

the substance unnecessary? [§6518(m)(6)]

X

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 281/302
Category 3. Is the substance compatible with organic production practices? Ash from Manure Burning: 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X Ash from manure burning is a by-product of 

the poultry factory farm industry, while we 

support the need to find creative solutions to 

prevent environmental pollution and public 

health concerns due to the build-up of excess 

manure accumulation, we don’t support the 

industry creating the need.

2. Is the substance compatible with a system of 

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

X See above.

3. If used in livestock feed or pet food, is the 

nutritional quality of the food maintained 

with the substance? [§205.600(b)(3)]

X

4. If used in livestock feed or pet food, is the 

primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, is the 

primary use to recreate or improve flavors, 

colors, textures, or nutritive value lost in 

processing (except when required by law)? 

[§205.600(b)(4)]

X

6. 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

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 282/302
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal - Squid & Squid Byproducts

March 1, 2016

Introduction

Shoreside Organics, LLC submitted a petition in April, 2015 to add “Squid and Squid Byproducts” to the 

National List of Allowed and Prohibited Substances section 205.601(j)(7) for use as a fertilizer.

205.601 Synthetic substances allowed for use in organic crop production. ...the following synthetic 

substances may be used in organic crop production: Provided, that, use of such substances do not 

contribute to contamination of crops, soil or water... (j) As plant or soil amendments. (7) Liquid fish 

products – can be pH adjusted with sulfuric, citric or phosphoric acid. The amount of acid used shall 

not exceed the minimum needed to lower the pH to 3.5.

The petitioner would like acid-adjusted squid products to be categorized as fish products for use in organic 

production. 

Background 

The use of squid and squid byproducts for use in agriculture date back to the 1800’s when much of the 

product was shipped from CA market squid fisheries to Asian countries for consumption and fertilizer 

applications. Squid byproducts make up 52% of the total body weight and include the squid ink, pen, skin, 

milt, liver and viscera and are typically discarded as waste. There are several uses for these byproducts 

including food, medicinal and soil amendment uses. Squid and squid byproducts are the starting ingredients 

in the production of enzymatically produced hydrolysates with N-P-K values ranging from 2-2-2 to 3.3-7.3-2 

or more. Seafood derived hydrolysates, including squid and squid byproducts, have been used both as foliar 

sprays and soil amendments for propagating cranberries, cherries and apples. In general, squid byproducts 

are chopped, heated, digested with natural enzymes and stabilized with an acid such as phosphoric, sulfuric 

or citric acid to prevent microbial growth.

Squid are commercially harvested using nets directly above spawning grounds during mating season 

primarily for calamari. Fisherman target spawning squid because they die shortly after reproduction. There 

are several squid fisheries throughout the world. There are two main squid fisheries in the US including 

along the Atlantic coast for long finned squid and along the Pacific coast for market squid. The US Pacific 

squid fishery is managed by the CA Department of Fish and Game, the National Oceanographic and 

Atmospheric Administration (NOAA) Fisheries, and the Pacific Fishery Management Council. Atlantic squid 

are managed in federal waters by NOAA Fisheries in conjunction with the Mid-Atlantic Fishery Management 

Council. Management includes seasonal catch limits, timed fishery closures, administration of permit 

issuance and limitations on using lights to attract squid to ensure uninterrupted spawning. 

Discussion

Squid are littoral invertebrates classified into the phylum Mollusca, class Cephalopoda and order Loligo 

(later renamed Doryteuthis). There are an estimated 300 squid species known throughout the world. 

Common to the northeastern Atlantic coast is the longfin squid, species Doryteuthis (Loligo) pealli. Common 

to the US west coast is the market squid, species Doryteuthis (Loligo) opalescens. 

Per the TR, squid differ anatomically and phylogenetically from fish. The US Food and Drug Administration 

(FDA) defines “fish” to mean fresh or saltwater finfish, crustaceans, other forms of aquatic animal life 

(including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 283/302
roe of such animals) other than birds or mammals, and all mollusks, where such animal life is intended for 

human consumption. The term “fishery products” means any human food product in which fish is a 

characterizing ingredient. Molluscan shellfish means any edible species of fresh or frozen oysters, clams, 

mussels, or scallops, or edible portions of such species, except when the product consists entirely of the 

shucked adductor muscle. This definition is not inclusive of squid, despite its classification as a mollusk. 

Scientifically, squids are cephalopod mollusks; however, for legal purposes and because they are part of a 

defined fishery, squid can be included “as other forms of aquatic life” per the FDA fish definition. Squid and 

squid byproduct hydrolysate have potential uses as food products.

The Canadian Organic Standard allows for the use of fish products; in Canadian fisheries, the definition of 

fish includes marine invertebrates such as squid. The EU Organic Standard allows the use of molluscan 

(squid) products from sustainable fisheries and may be used in organic production of feeds for nonherbivores; squid products are not explicitly authorized for use in organic production. The Japanese Organic 

Standard permits the use of food industry byproducts of fish origin if they are derived from natural sources; 

mollusks (squid) are included in Japanese fisheries. IFOAM permits the use of fish and shell products and 

food processing of animal origin. 

The Subcommittee recommends amending the current listing to read: Liquid fish and squid products – can 

be pH adjusted with sulfuric, citric or phosphoric acid. The amount of acid used shall not exceed the 

minimum needed to lower the pH to 3.5.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

Subcommittee Action & Vote 

Classification Motion: Move to classify Squid & Squid Byproducts as synthetic. 

Motion by: Carmela Beck 

Seconded by: Zea Sonnabend

Yes: 6 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

Listing Motion: Move to list Squid & Squid Byproducts at §205.601(j) of the National List – with the 

annotation – can be pH adjusted with sulfuric, citric or phosphoric acid. The amount of acid used shall 

not exceed the minimum needed to lower the pH to 3.5. 

Motion by: Carmela Beck 

Seconded by: Zea Sonnabend

Yes: 6 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

 

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB March 1, 2016

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 284/302
NOSB Evaluation Criteria for Substances Added To the National List - Crops

Category 1. Adverse impacts on humans or the environment? Squid & Squid Byproducts

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X TR (219-220; 562-563): If squid or squid 

byproduct fertilizers are over applied they 

can leach nitrogen and phosphate into the 

soil. Discharges of dead squid & wastewater 

boost ammonia concentrations & reduce 

oxygen content in the water posing a threat 

to marine life.

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X TR (191-192): Disposal is regulated as a solid 

waste by the US EPA. 

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X TR (78-81): Even without fishing, the entire 

population replaces itself annually. The stock 

is entirely dependent on successful spawning 

from each generation coupled with good 

survival of recruits to adulthood.

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

X

6. Is there a toxic or other adverse action of the 

material or its breakdown products?

[§6518(m)(2)]

X

7. Is there persistence or concentration of the 

material or breakdown products in the 

environment? [§6518(m)(2)]

X TR (489-490; 524-525): Squid & squid 

byproduct hydrolysate is used as fertilizer in 

crop production providing organic matter. At 

high levels of application there is greater 

potential for leaching of nitrogen and 

phosphorus.

8. Would the use of the substance be harmful 

to human health or the environment? 

[§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]

X TR (674-676; 718; 727-733) Manufacture 

waste of fats and oils must be properly 

treated or can lead to pollution. International 

squid fishing remains a concern of human 

rights advocacy particularly in SE Asia & NZ 

where debt bondage and captive 

enslavement are practiced. Illegal, 

unreported & unregulated fishing is a 

significant problem affecting the marine 

ecosystem (examples cited China, Chile, 

Thailand, and India).

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 285/302
9. Are there adverse biological and chemical 

interactions in the agro-ecosystem? 

[§6518(m)(5)]

X TR (614-615; 622-623): Decomposition of 

squid & squid byproducts provide starting 

ingredients for humus formation which 

comprises much of the organic matter in soil. 

Microbial activity is higher in soils fertilized 

with squid & squid byproducts hydrolysate 

than comparable soils fertilized with other 

organic fertilizers or synthetic mineral 

products.

10. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518(m)(5)]

X

Category 2. Is the Substance Essential for Organic Production? Squid & Squid Byproducts

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X TR (464; 479-482): Squid and squid 

byproduct hydrolysates are similar in 

composition to fish emulsions. The addition 

of sulfuric and phosphoric acid are 

considered synthetic.

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

X

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

X TR (738-739): Raw animal manure, 

composted plant and animal materials & 

uncomposted plant and animal materials.

8. Are there any alternative substances? 

[§6518(m)(6)] 

X TR (742-746): Aquatic plant extracts, 

elemental sulfur, humic acids, lignin 

sulfonate, micronutrients, & liquid fish 

products.

9. Are there other practices that would make 

the substance unnecessary? [§6518(m)(6)] 

X TR (775-781): Use of cover crops, crop 

rotations, no-till and the application of plant 

and animal materials.

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NOSB Evaluation Criteria for Substances Added To the National List - Crops 

Category 3. Is the substance compatible with organic production practices? Squid & Squid Byproducts

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X

2. Is the substance compatible with a system of 

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

X

3. If used in livestock feed or pet food, is the 

nutritional quality of the food maintained 

with the substance? [§205.600(b)(3)]

X

4. If used in livestock feed or pet food, is the 

primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, is the 

primary use to recreate or improve flavors, 

colors, textures, or nutritive value lost in 

processing (except when required by law)? 

[§205.600(b)(4)]

X

6. 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

X (TR 298-304): OFPA does not specifically list 

squid or squid byproducts, however, it does 

list fish emulsion. In US law, the term “fish” is 

often taken to mean finfish, mollusks, 

crustaceans, and all other marine animal and 

plant life with the exclusion of marine 

mammals and birds. Squid are considered 

mollusks.

livestock parasiticides and medicines

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

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NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 288/302
National Organic Standards Board

Crop Subcommittee

Petitioned Material Proposal - Hypochlorous Acid 

February 16, 2016

Summary of Proposed Action:

On May 29, 2015 the NOP received a petition to add Hypochlorous Acid (CAS #7790-92-3) to the National 

List at §205.601 - Synthetic substances allowed for use in organic crop production. This material is being 

petitioned for use as an antimicrobial/sanitizer for use on equipment and raw agricultural products. The 

petition was forwarded to the Handling Subcommittee on June 3, 2015 and later that summer the Crops 

Subcommittee was asked to review this material as well, since there are multiple listings being requested 

by the petitioner. The Livestock Subcommittee is also reviewing hypochlorous acid. 

The petition was submitted by Botanical Food Company Pty Ltd. Hypochlorous acid (electrolyzed water) is 

being petitioned for use in organic crop production for a couple of different uses, including: a) as a postharvest sanitizer for raw herb and spice materials ˂60ppm and b) as an equipment and cold room sanitizer 

˂200ppm. 

This petition has been submitted in response to a policy memo issued by the NOP on June 9, 2014: PM 14-3 

Electrolyzed Water. The memo was issued as a response to requests asking for the National Organic 

Program to clarify whether electrolyzed water (EW) was allowed as a sanitizer and antimicrobial agent for 

use in organic production and handling.

The NOP felt that the allowance of EW by a certifier or a material evaluation program were based on an 

incorrect interpretation of the allowance for chlorine materials on the National List of Allowed and 

Prohibited Substances at 7CFR §205.600-606. The NOP requested that certifiers ensure that the use of EW 

was not allowed in organic handling or production and that any party wishing for further consideration of 

EW for use in organic handling or production, should then submit a petition to get it added to the National 

List. Thus, the rationale for the petition currently before the Crops subcommittee and the full NOSB is in 

response to the NOP policy memo.

Manufacture and Uses of the Substance:

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).

The effectiveness of hypochlorous acid as an active sanitizing agent is determined in large part by the 

solution pH. Hypochlorous acid exists interchangeably with other chlorine species, including chlorine, 

hydrogen chloride (aqueous and gaseous) and hypochlorite. In a controlled pH environment hypochlorous 

acid will exist as the dominant chlorine species under pH conditions ranging from 2 to 7. (TR lines 84-89).

EW has received recent attention as an alternative to other chlorine disinfectants and sanitizers. A number 

of studies have demonstrated the strong antibacterial activity of EW against foodborne pathogens on raw 

agricultural products. Similar studies and actual in field use (and facility use) has demonstrated similar 

activity when used to sanitize equipment and storage facilities. This material was (prior to the USDA/NOP 

memo PM 14-3 Electrolyzed Water) previously approved by at least one material review organization and 

multiple certifiers for use on crops and allowed for uses other than what is currently being petitioned. Prior 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 289/302
to the NOP memo it was also beginning to be used for control of powdery mildew in apples and to aid in 

prevention of other pathogens or microbial contamination on fresh fruits and vegetables (leafy lettuce) that 

might pose a risk to human health. 

According to the Hypochlorous Acid TR (August 13, 2015) it states that some of the advantages of using EW 

are: 1) EW is as effective as any chlorine treatment, 2) it is not necessary to handle potentially dangerous 

chemicals, e.g. chlorine gas, chlorine dioxide, bleach, etc.,3) the apparatus used to produce EW is relatively 

inexpensive and easy to operate, 4) because only water and sodium chloride (salt) are used in EW 

production, it is environmentally more friendly of a compound compared to some of the alternative 

materials, and 5) the properties of EW are controlled on site during the electrolysis process. It should also 

be mentioned that since the materials from both of the cathodes are actually used during this process and 

final product use, there are no bi-products created during the formulation of Electrolyzed Water and 

therefore nothing to dispose of or that could be considered to be of a negative environmental concern.

Discussion:

From an environmental impact perspective, EW would appear to pose less of a risk for the environment 

than some of the alternatives since it is made from water and salt. There are no by-products to be disposed 

of since all of the materials are formulated and used in the final application process. Also, it would appear 

that EW would pose less of a risk to human health and/or worker health compared to some of the possible 

alternative products as well. According to the August 13, 2015 TR hypochlorous acid at a pH 6.0 to 7.5 is 

safer to use that other disinfectants containing chlorine. The level of chlorine in EW is usually over ten 

thousand times less than that of common household bleach. The on-site production helps to alleviate the 

need to transport other materials that may be more hazardous to handle, thus reducing the risk of 

exposure to the worker and for possible environmental contamination if improperly handled. The optimum 

range for the material that previously was being used in organic farming or currently is being used (in 

conventional farming) is at a pH of 6.0 to 7.5 according to the petitioner. This pH range gives a more 

effective and a more stable product that is safer for the environment and human safety as well than those 

using the lower pH levels. According to the TR it mentions that in forms of hypochlorous acid that are at a 

pH<4.0, dissolved chorine gas can be rapidly lost due to volatilization, decreasing the biocidal effectiveness 

of the solution over time, but also creating possible human health and safety issues (Fisher, 2009). The 

more neutral, the pH of the material, the safer and more stable the substance appears to become.

The primary functions of EW are as an anti-microbial, sporicidal, and bactericidal agent. Some currently 

allowed alternatives to EW are: Sodium and/or calcium hypochlorite (bleach), isopropanol, chlorine dioxide, 

peroxyacetic acid, citric acid, acetic acid, ascorbic acid, vinegar are some of the materials currently used. 

The petition seeks to add electrolyzed water/hypochlorous acid to the National List for use in organic crop 

production as an alternative to the other substances currently allowed. The petitioner states that EW will 

be used post-harvest on farm as a sanitizer for use on raw herbs and spices including, but not limited to; 

basil, cilantro, parsley, chili peppers, garlic, and ginger. EW would also be used on farm to sanitize 

equipment and as a cold room sanitizer.

Electrolyzed water, although produced via a different mechanism, has the same mode of action as sodium 

and calcium hypochlorite (both of these materials are currently on the National List). In fact, the main 

active ingredient in their dilute aqueous solution form is hypochlorous acid, the same material produced as 

the Anolyte component of electrolyzed water. The reason hypochlorous acid can be ten thousand times 

less concentrated than sodium and calcium hypochlorous solutions and still be an effective sanitizer is that 

sodium and calcium hypochlorite solutions (bleach) have a high pH. When the pH is high, the hypochlorous 

acid/hypochlorite chemical equilibrium strongly shifts towards the presence of hypochlorite, whereas at 

neutral pH the chemical equilibrium shifts towards the presence of hypochlorous acid, the effective 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 290/302
sanitizing compound. Therefore, hypochlorous acid (EW) is a safer product, for the environment and for 

human health, than chlorine sanitizer materials currently on the National List.

During the public comment period prior to the fall 2014 NOSB meeting there were several public comments 

submitted in response to the NOP’s decision to halt the allowed use of Hypochlorous acid per their memo 

PM 14-3 sent out on June 9, 2014. One of those organic stakeholders provided written public comment on 

September 28, 2014 that included multiple peer-reviewed scientific journal articles. These articles provided 

support to the claim that electrolyzed water was a safe sanitizer, providing the same degree of antimicrobial control without the toxic risk to employees, the crops, or the harvested products it is applied to. 

These articles also helped to provide support that this material might better support the basic fundamental 

principles of organic crop production compared to many of the alternatives currently being used. These also 

helped to support the petitioners claim as to why this material is needed – because it is safer to use on such 

crops as lettuce, spinach, and other sensitive vegetables and herb crops. 

This material does appear like it could help the organic crop producers meet the requirements of 

compliance with the FDA’s Food Safety Modernization Act, while at the same time providing the producer 

with a material more compatible with the fundamental principles of organic crop production. It could 

possibly be looked at to provide a material that is less concerning for its impact on human and 

environmental health, while helping to meet a necessary need of the organic producer for materials that 

they can use in the sanitizer/anti-microbial listing for use in organic crop production.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

Subcommittee Action & Vote

Classification Motion: Move to classify hypochlorous acid as synthetic. 

Motion by: Harold V. Austin IV 

Seconded by: Francis Thicke 

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

Listing Motion: Move to list hypochlorous acid at §205.601 of the National List: Synthetic substances 

allowed for use in organic crop production. §205.601(a) As algicide, disinfectants, and sanitizer.

(2)chlorine materials (iv) Hypochlorous acid.

Motion by: Harold V. Austin IV 

Seconded by: Emily Oakley

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

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB February 16, 2016

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 291/302
NOSB Evaluation Criteria for Substances Added To the National List – Crops

Category 1. Adverse impacts on humans or the environment?Hypochlorous acid

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

x According to the petition electrolyzed water 

can be made on-site. In this process there 

would not be any residual product to dispose 

of. If produced off-site and sold as a finished 

product then there could be a possibility of 

environmental contamination as the result of 

an accident or a spill. The TR does state that

in forms of hypochlorous acid that are at a 

pH<4.0, dissolved chlorine gas can be rapidly 

lost due to volatilization, decreasing the 

biocidal effectiveness of the solution over 

time, but also creating possible human 

health and safety issues (Fisher, 2009). The 

more neutral, the pH of the material, the 

safer and more stable the substance appears 

to become.

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

x This substance is formed by the electrolysis 

of a sodium chloride solution. Any 

environmental concerns would be from a 

spill during manufacturing or transport of a 

formulated end product.

3. Are there any adverse impacts on 

biodiversity? (§205.200)

x The TR, (lines 596-612) does state that 

hypochlorous acid in aqueous solutions at 

pH< 7. Was of minimal toxicity to birds, but 

could be very toxic to fish and freshwater 

invertebrates. 

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)] 

x Contaminants listed in the US Food and Drug 

Administration’s Guidance for Industry: 

Action Levels for Poisonous or Deleterious 

Substances in Human Food and Animal Feed, 

are unlikely to be found in hypochlorous acid 

since it is the electrolysis product of two 

generally recognized as safe materials, salt 

and water (TR lines 568-571).

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)] 

x The TR (lines 140-153) mentions that there 

can be a reaction with organic material 

(humic acid) which can lead to some

potential concerns. It does go onto state 

though: It is generally accepted that 

carcinogenic and teratogenic 

trihalomethanes and haloacetic acids are not 

formed by the action of hypochlorous acid in 

neutral or near-neutral solutions (Satyawli et 

al., 2007). 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 292/302
6. Is there a toxic or other adverse action of the 

material or its breakdown products?

[§6518(m)(2)]

x

7. Is there persistence or concentration of the 

material or breakdown products in the 

environment? [§6518(m)(2)]

x According to the TR (lines 602-612) 

hypochlorous acid solution decomposes very 

slowly in the dark but more rapidly in the 

presence of light, rapidly in full sun light by 

producing hydrogen chloride and oxygen. 

Released into the environment it is 

distributed into water and air, with an 

estimated half-life of 1-4 hours. A potential 

for bioaccumulation or bioconcentration of 

active chlorine species can be disregarded, 

because of their water solubility and their 

high reactivity.

8. Would the use of the substance be harmful 

to human health or the environment? 

[§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]

x Information provided in the petition states 

that compared to other types of chlorine, 

electrolyzed water is usually used at an 

active rate that is ten thousand times less 

than that of common household bleach. The 

TR (lines 624-626) mentions that the human 

innate immune system uses hypochlorous 

acid to fight infection but also directs it 

against host tissue in inflammatory diseases 

(Kettle et al.,2013). Chlorine disinfectants 

have been shown to cause occupational 

dermatitis or skin irritation (TR line 662).

9. Are there adverse biological and chemical 

interactions in the agro-ecosystem? 

[§6518(m)(5)]

x See the answer to question #5 above.

10. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518(m)(5)]

x

 

Category 2. Is the Substance Essential for Organic Production? Hypochlorous acid

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] x

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

x Electrolyzed water is the product of the 

electrolysis of a dilute sodium chloride 

solution in an electrolysis cell containing a 

semi-permeable membrane. This process 

creates hypochlorous acid, hypochlorite ion, 

and hydrochlorite at the anode and sodium 

hydroxide at the cathode. (TR lines 48-68) 

August 13, 2015 TR.

3. Is the substance formulated or 

manufactured by a process that chemically 

x

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 293/302
changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

x

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

x

6. Is there an organic substitute? 

[§205.600(b)(1)] 

x Organic acids such as citric acid, lactic acid, 

malic acid, and vinegar are some alternative 

materials. 

7. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

x Hot water can be used in some instances. 

8. Are there any alternative substances? 

[§6518(m)(6)] 

x Some alternative substances are: Sodium 

and/or calcium hypochlorite (bleach), 

isopropanol, chlorine dioxide, peroxyacetic 

acid, citric acid, acetic acid, ascorbic acid, and 

vinegar. Copper sulfate is another possible 

alternative depending on the use. 

9. Are there other practices that would make 

the substance unnecessary? [§6518(m)(6)]

x

Category 3. Is the substance compatible with organic production practices? Hypochlorous acid 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

x Compared to many of the alternative 

materials currently being used electrolyzed 

water could provide a safer and effective 

alternative. (especially when produced using 

the on-site electrolysis process)

2. Is the substance compatible with a system of 

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

x See answer to question #1 of this category.

3. If used in livestock feed or pet food, is the 

nutritional quality of the food maintained 

with the substance? [§205.600(b)(3)]

x

4. If used in livestock feed or pet food, is the 

primary use as a preservative? 

[§205.600(b)(4)]

x

5. If used in livestock feed or pet food, is the 

primary use to recreate or improve flavors, 

colors, textures, or nutritive value lost in 

processing (except when required by law)? 

[§205.600(b)(4)]

x

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 294/302
6. 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

x

toxins derived from bacteria x

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

x

livestock parasiticides and medicines x

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

x May be used to sanitize equipment

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 295/302
NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 296/302
National Organic Standards Board

Crops Subcommittee

Petitioned Material Checklist - Soy Wax

January 19, 2016

Summary of Proposed Action:

Soy wax has been petitioned as a synthetic substance for use in organic mushroom production to seal plugs 

and ends of logs inoculated with mushroom spawn. Soy wax is intended to be used for the same purpose as 

microcrystalline cheesewax, which is currently listed at §205.601(o) as a production aid in the production of 

mushrooms grown on logs. 

Soy wax is produced from oil extracted from soybeans. The oil is hydrogenated, making it a solid at room 

temperature. Crystalline cheesewax, which is currently listed for the use, is made from petroleum. Soy wax, 

which is now available from non-GMO, domestically-produced soybeans, was petitioned for use because it 

has fewer environmental and health impacts than products made from petroleum.

Soy wax is considered synthetic because it undergoes a chemical change that does not happen naturally 

when it is hydrogenated. Hydrogenation is the process whereby the poly- and mono-unsaturated oils are 

solidified in order to increase the viscosity. As the petition describes it, this process involves the reaction of 

hydrogen with soybean oil at elevated temperature (140-225o

C) in the presence of a nickel catalyst. 

Therefore, even if soy wax were made from organic soybeans by this process, it would be synthetic.

The Crops Subcommittee supports the addition of soy wax made from non-GMO plant material to the 

National List as an alternative to microcrystalline cheesewax, which is made from petroleum.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

Subcommittee Action & Vote: 

Classification Motion: Move to classify soy wax as synthetic. 

Motion by: Francis Thicke 

Seconded by: Colehour Bondera

Yes: 4 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

Listing Motion: Move to list soy wax at §205.601 of the National List (o) - As production aids. Soy wax

(CAS # 8016-70-4) - for use in log grown mushroom production. Must be made from non-GMO 

soybeans. 

Motion by: Francis Thicke 

Seconded by: Colehour Bondera 

Yes: 4 No: 0 Abstain: 0 Absent: 1 Recuse: 0

 

 Proposed Annotation: Must be made from non-GMO soybean oil. 

 Basis for annotation: ☐ To meet criteria above ☒ Other regulatory criteria ☐ Citation 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 297/302
Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB January 19, 2016

NOSB Evaluation Criteria for Substances Added To the National List - Crops

Category 1. Adverse impacts on humans or the environment? Soy Wax

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X 

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X 

3. Are there any adverse impacts on 

biodiversity? (§205.200) X 

Soy wax (hydrogenated soy oil) is 

biodegradable and non-toxic

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X 

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems? 

[§6518(m)(1)]

X 

6. Is there a toxic or other adverse action of the 

material or its breakdown products?

[§6518(m)(2)]

X 

Soy wax breaks down into carbon dioxide 

and water.

7. Is there persistence or concentration of the 

material or breakdown products in the 

environment? [§6518(m)(2)]

X 

Soy wax is hydrogenated soybean oil and

non-toxic and biodegradable in soil.

8. Would the use of the substance be harmful 

to human health or the environment? 

[§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]

X 

Soy wax for mushroom production is not 

intended to be ingested, but would not be 

harmful it if were.

9. Are there adverse biological and chemical 

interactions in the agro-ecosystem? 

[§6518(m)(5)]

X 

10. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518(m)(5)]

X 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 298/302
NOSB Evaluation Criteria for Substances Added To the National List - Crops

Category 2. Is the Substance Essential for Organic Production? Soy Wax

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)]

X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X 

Hydrogenation of soybean oil

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

X 

The chemical change is hydrogenation, which 

alters carbon bonding with hydrogen. 

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X 

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)] X

6. Is there an organic substitute? 

[§205.600(b)(1)] X

Soy wax could be made with organic soybean 

oil, but would still be considered synthetic.

7. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)] X

8. Are there any alternative substances? 

[§6518(m)(6)] X

Microcrystalline cheesewax, which is 

currently on the National List.

9. Are there other practices that would make 

the substance unnecessary? [§6518(m)(6)] X 

The sealing of log ends and plug holes is 

considered necessary in mushroom 

production.

Category 3. Is the substance compatible with organic production practices? Soy Wax 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X 

Soy wax is more consistent and compatible

with organic farming and sustainable 

agriculture than the petroleum-based 

microcrystalline cheesewax currently in use.

2. Is the substance compatible with a system of 

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

See #1 above.

3. If used in livestock feed or pet food, is the 

nutritional quality of the food maintained 

with the substance? [§205.600(b)(3)]

X 

4. If used in livestock feed or pet food, is the 

primary use as a preservative? 

[§205.600(b)(4)]

X 

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 299/302
5. If used in livestock feed or pet food, is the 

primary use to recreate or improve flavors, 

colors, textures, or nutritive value lost in 

processing (except when required by law)? 

[§205.600(b)(4)]

X 

6. 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

X 

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X 

livestock parasiticides and medicines

X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X 

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National Organic Standards Board

Crops Subcommittee

Discussion Document - EPA List 4 on §205.601(m) Annotation Change

February 2, 2016

Introduction

The Crops Subcommittee is working towards a solution to reviewing the inerts that were formerly on 

EPA List 4 by collaborating with the EPA Safer Choice Program (SCP) (formerly Design for the 

Environment Program). The NOSB supported a recommendation to change the existing listing for inert 

ingredients at its October 2015 meeting. An additional annotation change is proposed for posting (but 

not voting) so that all stakeholders can be aware of an impending proposal for a change to the listing.

Background

For background here are the final two paragraphs of the EPA List 4 Sunset Review:

The Crops Subcommittee (CS) fully agrees with the frustration over how long it is taking to implement 

the NOSB recommendation to review inerts. We sincerely hope that the vote to proceed will be taken 

soon so that the program to work with the Safer Choice Program can begin in 2016. Once it begins, the 

inerts manufacturers will have to submit their products to Safer Choice to be reviewed. This will clearly 

favor those inerts that have the best chance of being approved, because the ones that are not likely to

be approved will not apply until absolutely forced to do so. The CS believed that it would be better to 

put some of the inerts categories that are unlikely to end up on the SCIL list on notice sooner than the 

very end of the whole SCP project so that they could start moving towards reformulation sooner rather 

than later. That is why we requested a Technical Report for nonylphenol ethoxylates (NPEs) and are 

considering Technical Report requests for other categories that will not pass the SCP. We are doing this 

with the expectation that there will be a long period of time before full implementation of this program, 

so that everyone doesn't complain at the end that there wasn't enough notice.

The accompanying annotation discussion proposal to remove NPEs from organic products has one clear 

message from the NOSB: START REFORMULATING NOW! The change will definitely not be sudden, but it 

is clear that eventually NPEs will not be allowed in organic. Unless all stakeholders communicate this in 

their messaging to their constituents, this will bog down the change even further.

Discussion: Proposal to Prohibit NPEs

As stated above, if the goal is to get NPEs out of organic products without disrupting the tools that 

organic farmers use we need to give as much notice as possible. No matter how we approach it 

companies will likely object about not having enough notice and time. They did the same thing when List 

3 was first prohibited. The 2000 Final Rule establishing the organic regulations allowed an 18-month 

period for compliance with the new prohibition on List 3 inerts, and the EPA cooperated by fast-tracking 

some chemicals that were on List 3 to move to List 4. This proved to be enough time for products to 

either be reformulated or get re-classified. In the end, only a few products came off the list and these 

were soon replaced by acceptable organic alternatives.

One of the biggest challenges, however, is reaching the formulators and suppliers of the products that 

need to be reformulated. We are requesting input from the public on how to reach this group of 

stakeholders so that there is plenty of notice.

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 301/302
Both the information in the TR and the comments from the public were clear that NPEs are a group that 

we should attempt to remove from organic products. Because this is a discussion document the Crops 

Subcommittee has not prepared a checklist at this time, but readers are encouraged to read the

2015 Technical Report on NPEs for the details. 

The Crops Subcommittee believes that a 3-year notice should be enough time to remove the most 

problematic inerts. If the NOSB waits until all the other inerts are reviewed through the SCP process to 

announce which ones are prohibited it will take a lot longer. For NPEs, Crops has chosen to put forth a 

discussion document on a proposed annotation to make the public aware of its intention. The document 

will circulate until fall of 2016, at which time the NOSB will vote on it. Expect another 18 months for rule 

change with a comment period and perhaps a grace period in the rule as there was for List 3 inerts. This 

would be 3 to 4 years at least. So why not start now?

The Proposed Annotation change for discussion is as follows: 

§205.601(m) As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA), 

for use with nonsynthetic substances or synthetic substances listed in this section and used as an active 

pesticide ingredient in accordance with any limitations on the use of such substances. 

Except for inerts from the group known as Nonylphenol Ethoxylates. 

Discussion Questions

1. Is the timeline outlined above enough time to reformulate products?

2. For Accredited Certification Agencies and Materials Review Organizations: how many products that 

you approve contain NPEs and can you characterize the generic categories that they fall into?

3. Please provide suggestions for outreach to the parties affected by this change.

Motion to approve this discussion document for posting, and work in conjunction with the Livestock 

Subcommittee on the proposal. 

Motion by Zea Sonnabend

Seconded by Harold V. Austin, IV

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

Approved by Zea Sonnabend, Subcommittee Chair, to transmit to NOSB February 2, 2016

NOSB APRIL 2016 PROPOSALS & DISCUSSION DOCUMENTS 302/302