Meeting Of The National Organic Standards Board

May 22, 2012

1

United States Department of Agriculture

Agriculture Marketing Service (AMS)

National Organic Program (NOP)

Meeting Of The National Organic Standards Board (NOSB)

May 22, 2012

Hotel Albuquerque Old Town

800 Rio Grande Boulevard NW

Albuquerque, NM 87104

The National Organic Standards Board convened at 8:00 a.m. with Barry Flamm, Chairperson, 

presiding.

Members Present

Barry Flamm, Chairperson

Harold Austin

Carmela Beck

Colehour Bondera

Joe Dickson

Tracy Favre

Jay Feldman

John Foster

Wendy Fulwider

Nick Maravell

Jean Richardson

Zea Sonnabend

Robert “Mac” Stone

Jennifer Taylor

Calvin Reuben Walker 

National Organic Program Staff

Miles McEvoy, Deputy Administrator

Melissa Bailey, Director, Standards Division

Dr. Lisa Brines, National List Manager

Emily Brown-Rosen, Agricultural Marketing Specialist, Standards Division

Michelle Arsenault, NOS Advisory Board Specialist

**Note: This is not a certified transcript, and may contain errors or omissions.
Meeting Of The National Organic Standards Board

May 22, 2012

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TABLE OF CONTENTS

PAGE

Call to Order .................................................................................................. 3

Secretary’s Report ......................................................................................... 8

NOP Update ................................................................................................ 10

Break ........................................................................................................... 32

Open Public Comment ................................................................................ 32

Lunch ........................................................................................................... 67

Open Public Comment (continued) ............................................................ 67

Compliance, Accreditation and Certification Committee .......................... 80

Break ........................................................................................................... 95

GMO ad hoc Committee ........................................................................... 100
Meeting Of The National Organic Standards Board

May 22, 2012

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Barry Flamm: Meeting will come to order. Welcome to the NOSB meeting here in the Land of

Enchantment. This week we will be hearing important comments from the public that 

will guide the final recommendations that the Board will make. We have already received 

around 1700 written comments, will be considered equally. Next on the agenda is the 

approval of our agenda. Are there any changes that the Board wishes to make to the 

agenda? The Board recognizes Madame Secretary.

Wendy Fulwider: Thank you, Barry. In response to public comment, the Livestock Committee 

intends to seek additional input from interested individuals to clarify the issues at hand 

relative to GMO vaccine use under the NOP. It is clear additional information is needed 

for the committee to deliberate in making a final recommendation. We will keep an 

active conversation open by tabling the vote at this meeting. We will bring back a refined 

recommendation at a future meeting of the Board for final vote. Timely, active 

deliberation is necessary to address the ruling of the OGC on this issue. It is vitally 

important to capitalize on the expertise assembled at this meeting to further a workable 

recommendation. We look forward to your input during the Livestock Committee's 

discussion session on the agenda. Thank you. 

Barry Flamm: Without objection, the change is accepted. Is there any other change to the 

agenda? Since there is no other change to the agenda, the agenda is approved. 

I have a couple of announcements to make. Ben, who is doing the recording for us, has 

asked the members to speak into the microphone. I have already violated this several 

times, as you noticed. It takes a little getting used to. He is over there and is ready to help 

us at any time. Also, I would like to alert the Board that there is a New York Times 

photographer here. He will be taking, at various times during the day, will be taking 

pictures, which will apparently appear in the New York Times. 

Next on our agenda is the introductions. I would like to lead off with having former 

Board members in the audience to stand and be recognized. These people have done 

tremendous work for the organic community in the past. Don't be bashful. Where are 

you? I know you are here. [Applause] Thank you very much. Next, I would like the new 

Board members to introduce themselves, and just say a few words about their background 

and what they would like to achieve. If I could, I would like to start off with Tracy.

Tracy Favre: I'm Tracy Favre with Holistic Management International. I come from and 

environmental engineering background, and I now work for an organization that trains 

people on systems approach to agricultural management. And I hope to bring a balanced 

view and pragmatic approach to the Board.

Barry Flamm: Thank you, Tracy. Zea, would you introduce yourself?

Zea Sonnabend: [Indiscernible -- low audio]

Barry Flamm: Thank you, Zea. [Indiscernible – low audio]
Meeting Of The National Organic Standards Board

May 22, 2012

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Zea Sonnabred: [Laughter] Okay.

Barry Flamm: By the end of the week, we will all get used to the mics.Herald, would you 

introduce yourself, please?

Harold Austin: Good morning. My name is Harold Austin. I’m the Director of Orchard 

Administration with Zirkle Fruit Company in the state of Washington. I oversee our food 

safety Programs, all of our quality Programs. I am directly involved with the management 

of our organic Program from growing to the packing side of it. We grow, pack, and sell

apples, cherries, blueberries, pears, and wine grapes. I’m also involved in the advisory 

Board for the Washington State Department of Ag’s organic Program as well. I've been 

involved in our area in organics for almost 20 years now. What I would like to do here is 

to represent the stakeholders from my area and across the country as a handler 

representative but also I bring to the Board, I think, a long line of experience in the 

farming side of it. I have grown up in the orchard industry my entire life. I look forward 

to serving on the Board and working with the stakeholders. Thank you.

Barry Flamm: Thank you, Harold. Carmela, would you introduce yourself please?

Carmela Beck: Good morning. My name is Carmela Beck and I work for Driscoll Strawberries 

Associates. I’m on the producers’ seat. I have about eight years of experience in the 

organic sector. I started out with QAI doing review of files. At Driscoll’s, I manage the 

organic Program. I work with all of our independent growers to maintain their organic 

certification, their OSPs. I also work with our handlers to maintain their organic 

certifications. I look forward to representing our constituencies and learning from all of 

you and also learning from all of the expertise of the Board members.

Barry Flamm: Thank you, Carmela. Finally, Jean, would you introduce yourself?

Jean Richardson: Good morning. I am Jean Richardson from Vermont. I have been an organic 

inspector for about the last 12 years in all kinds of farming and processing as well. I’m 

presently also an organic maple sugar producer, maple syrup that is, a sugar maker as we 

are called. With my family I started a family farm about 35 years ago in Vermont and 

grew everything that there was. And I started a lot of the early intensive pasture grazing 

systems which are now so common, of course, across all of the United States. Also a 

professor of environmental studies and environmental law at the University of Vermont 

with a background in biological sciences, bio-geography, Earth sciences, strong 

environmental interest, a lot of research in that area. And I am very much a pragmatist, a 

lot of practical experience, good background in both science and law that I think will help 

me a great deal as I try to represent consumers in this important arena. Thank you. 

Barry Flamm: Thank you, Jean. And now I would like the Board members who have been 

working diligently the last two, three years to introduce themselves starting with Jay, and 

then we will go around the table. Thank you.
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May 22, 2012

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Jay Feldman: Good morning, everybody. My name is Jay Feldman. I am the Executive Director 

of Beyond Pesticides, which was an organization founded in 1981. Our goal is to bridge 

the interest of farmers and consumers and environmentalists. Our Board is composed of a 

variety of people in the medical field, researchers, farmers, farm workers. Organic, we 

really view, is the solution to pesticide pollution. Quickly, I feel, given my history on 

this, having sat around the table when the actual Organic Foods Production Act was 

written, that my role is to focus on the law. And what our responsibilities are as the Board

vis-à-vis the law. But more than that, the core values and underlying principles that have 

driven that law and driven the market from zero almost when we started, to what it is 

today. So I am really excited about working with everybody on issues of integrity and 

growth under the banner of strict compliance with the law, the principles and the values. 

Thank you. 

Barry Flamm: Thank you, Jay. Calvin, would you introduce yourself please?

Calvin Walker: Yes, I would like to say good morning, everyone.

Crowd: Good morning. [Laughter]

Calvin Walker: I was appointed to the Board in the slot of public interest. As USDA celebrates 

150 years of service, all of us here in this room certainly hope that organics will be a 

major part of the next 150 years. I look forward to a productive meeting. Thank you.

Barry Flamm: Thank you, Calvin. I think John is back there in the corner. I can't see you, John. 

Would you introduce yourself?

John Foster: My name is John Foster. I'm -- this is my fifth meeting on the Board. I'm sitting in 

the other of the two handler positions. I am the Director of Compliance for quality food 

safety and organic integrity at Earthbound Farm. Grower, packer, shipper of organic 

produce. All we do is organic. We started in '84 on 2.5 acres of raspberries, and now we 

grow and market for approximately 200 growers of all manner of organic fruits and 

vegetables from many countries. So we focus more on marketing now. We also have our 

farming division that I don't oversee, but I'm pretty connected to also. I’m looking 

forward to another no doubt interesting meeting. This is one of my favorite activities, to 

get to spend time with this community. Thank you.

Barry Flamm: Thanks, John. Joe, would you introduce yourself please? 

Joe Dickson: Good morning. My name is Joe Dickson. I'm Global Quality Standards Coordinator 

at Whole Foods Market. We are a retailer operating about 300 organic and natural foods 

stores. My job at Whole Foods is to set standards for the products that we sell in our 

stores. I advise the company on food policy issues, organic compliance and manage our 

Programs related to organic certification and integrity. I occupy the retail seat on the 

national organic standards Board and I also serve on the Livestock Handling and Policy 

Development Committees as well as chairing the Compliance, Accreditation and 

Certification Committee. 
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May 22, 2012

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Barry Flamm: Thank you, Joe. Mac, would you introduce yourself please?

Mac Stone: My name is Mac Stone I’m a certified organic farmer from Kentucky. I sit on the 

certification rep. seat, and the Certification Committee, Livestock Committee and Policy 

Development Committee. 

Barry Flamm: Thanks, Mac. Wendy, would you introduce yourself please?

Wendy Fulwider: Thank you Barry. I own a third generation family farm that has been recently 

certified organic. My son is home making hay today. It is a diversified livestock 

operation, and we will be transitioning the dairy herd beginning in the fall. This is my 

fifth meeting on the Board. I am on the Livestock Committee and the Materials 

Committee. And I also work full-time for Organic Valley. So I look forward to having a 

really good meeting here, and very productive, this session.

Barry Flamm: Thank you, Wendy. Colehour, would you introduce yourself please?

Colehour Bondera: Yes, Hello. My name is Colehour Bandera, and I sit in one of the producer 

seats on the NOSB, and I think it's worth mentioning the fact that in my opinion, from my 

small-scale farm in Hawaii, but also from my perspective and background and

constituency, I really see the fact that since the vast majority of farms in the entire world 

but definitely in the United States are small scale, I try to make sure that our discussions 

on the committees I’m in and in general accommodate recognizing the impacts and the 

realities for small-scale farmers when we are making choices and putting forth 

recommendations.

I think that it is worth mentioning that I sit in this position from that perspective but also 

from the perspective of standing up for and standing with the background of organic 

integrity and seeking organic integrity is one of my driving forces. I really appreciate 

working with, like you have already heard, diverse perspectives and experiences on the 

Board, and that's what I anticipate continuing to do, henceforth. So thank you. 

Barry Flamm: Thank you, Colehour. And, Nick, would you introduce yourself please?

Nick Maravell: Hi. My name is Nick Maravell. I’m a certified organic producer for more than 

the last three decades. I hate to admit it. I started out all in vegetables, and now we have a 

diversified operation that includes vegetables, crops, livestock, organic seed production, 

poultry feed production, et cetera. And I am located in the state of Maryland.

Barry Flamm: Thank you Nick. And I am Barry Flamm, chair of the Board, as you may have 

suspected, for this year. And I see my job as working to coordinate this great group of 

people we have on the Board. In an effort to get the most out of them, I try to work them 

hard, and that is not hard to do because they are all hard workers. I am in my last year on 

the Board. I serve also on the CAC Committee, and the Crops, and Policy Development, 

and I was chair of that for the past four years, and I handed the reins over to Colehour a 
Meeting Of The National Organic Standards Board

May 22, 2012

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few months back. I am particularly happy to be here in Albuquerque, in New Mexico. 

This state was my first job after graduating in forestry. When I came out of what was then

Colorado A&M, I end up on the Gila National Forest. I’ve worked all over the state and I 

spent a year here in Albuquerque. Like everywhere else, it has changed a lot.

[Indiscernible – low audio] That’s the trouble sitting here. I missed a very important 

Board member everybody is pointing out to me. And I will complete my comments to say 

I am delighted to be here and work with this great group of people. And glad to see all of 

you in the audience. Jennifer, my sincere apologies.

Jennifer Taylor: No problem. Good morning. My name is Jennifer Taylor. I'm from Florida 

A&M University where I am coordinator of small farm Programs. I develop education 

and hands-on training opportunities, experiences for farmers that are interested in organic 

production and alternative kinds of production and management strategies as well as 

providing information and training for conventional farmers, assisting them to transition 

to organic production. Thank you. [Indiscernible – low audio] on the Board is to 

represent the public, to represent consumers. And I appreciate that. Thank you.

Barry Flamm: Thank you, Jennifer. You got the last word in for the Board. Next, I would like 

our deputy administrator, Miles McEvoy, to introduce himself and his staff, please.

Miles McEvoy: Good morning. Miles McEvoy, Deputy Administrator for the National Organic 

Program, part of the Agricultural Marketing Service. It's great to be here, and I will have 

more remarks in a few minutes. So I would like to introduce the staff here from national 

organic Program.

On my right I have Melissa Bailey who is back from maternity leave. She is our 

standards director and keeps all the rules going through the process of development, 

proposal, through the Office of General Counsel, back through the long and torturous 

path of clearance, which seems to get more and more complicated as the months go by. 

She is the one who makes that happen. On my left I have Dr. Lisa Brines, National List

Coordinator for the National Organic Program. Dr. Brines will be presenting background 

information on petitions and technical reports as we move through the meeting the next 

few days. Next to Lisa is Emily Brown-Rosen, who says she has been to every National 

Organic Standards Board meeting except one, is that right? One or two. Just a couple she 

has missed over the last couple -- I guess it's been 20 years now, the National Organic 

Standards Board. So she is the historian of the Board for the Program. She has a wealth 

of experience in organic certification and standards and the history of the Board. So she 

will be very valuable as we continue through the week. And finally we have Michelle 

Arsenault, one of the newest members of the NOP family. Michelle is the special 

assistant to the Board, who does all of the work on logistics, supports the Board in all the 

things that they do, keeps the subcommittee minutes, and she will be the one that handles 

all of the public comment in terms of scheduling the time and things like that. So, 

Michelle, welcome to the National Organic Standards Board meeting. Thank you.

Barry Flamm: Thank you. I think those of you who have been to previous meetings notice now a 

change in format of the agenda. And this is a trial to see if we can become even more 
Meeting Of The National Organic Standards Board

May 22, 2012

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efficient and make better decisions. So we are hoping that this will be an improvement. 

We think it's a step forward.

Another change you may notice from at least recent meetings is the arrangement at the 

table. And at least for my time on the Board, the NOP and the staff sat with their backs to 

the audience. And when there is questions or dialogs, I think it was difficult for all of you 

to really hear or appreciate what's going on. So this is a little change in layout of the 

tables is so that we can all see each other better. We can see the NOP staff, and I think 

most of you can see them pretty well. And also double screens are an attempt to improve 

the visual effect. 

It's been a tradition of the Board to remind ourselves and remind the participants in the 

meeting of the mission of the Board. And if you will give me a few moments, I would 

like to read from our policy manual on what the Board says its mission is. Of course, we 

have a statutory mission. And I think you are probably familiar with that. But let me read 

the mission that we have given ourselves. The NOSB’s mission is to provide effective 

and constructive advice, clarification, and guidance to the Secretary of Agriculture, 

concerning the National Organic Program, and the consensus of the organic community.

We will do this by several key activities. Assist in the development and maintenance of 

organic standards and regulations, review petition materials for inclusion or deletion on 

the National List, recommend changes to the National List, and communicate with the 

organic community. And this is probably one of our most important roles. And also 

communicate with the NOP staff. Next on our agenda is the Secretary's Report. Secretary 

Wendy Fulbright, please. 

Wendy Fulbright: Thank you, Barry. The transcript and voting record of the previous meeting 

has been distributed to the Board. Are there any corrections or additions?

Barry Flamm: Hearing none, the voting record and transcript of the last fall meeting is accepted. 

Next, Brett Baker, organic Program manager, I hope I have the title right, from the State 

of New Mexico, would like to welcome us. And Deputy Administrator Miles McEvoy 

will introduce Mr. Baker.

Miles McEvoy: We will get nice and formal here. Brett has been working in organic certification 

for a long time and he is the chief inspector for the New Mexico Department of 

Agriculture. I think that's a great title. He's been that chief inspector for a long time. 

Inspection is really the key element in terms of the organic certification process. So 

welcome Chief Inspector Brett Baker to welcome us here to New Mexico.

Crowd: [Applause]

Brett Baker: Thank you, Miles. Thank you everyone for coming here. Bienvenidos. Welcome to 

the Desert. Keep in mind this is mild spring weather. Drink lots of water. Remember that 

the more chili you eat, the more you perspire, and it acts as an evaporative cooler. It will 

keep you cooler that way. I've been working with the State of New Mexico's Organic 

Program since 1990, when Jay Friedman, who some of you might know, was still in law 
Meeting Of The National Organic Standards Board

May 22, 2012

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school and he was writing a bill to pass an organic rule for the State of New Mexico. I 

was minding my own business, growing heirloom native seeds when Jay called me up 

and asked if I wanted to be an inspector. Now since that time, little by little through 

attrition, the people who were the reviewers and certifiers slowly disappeared. And all of 

a sudden I looked around and found out that I was in charge of running the certification 

Program, which I still I'm doing. For many years, we were the New Mexico Organic 

Commodity Commission, an independent agency under the State of New Mexico. It was 

a little bit difficult and a rocky road just being basically a line item on the governor's 

budget, subject to any kind of veto and things going on in the Legislature. And just about 

a year ago, the administration of the state said that, well, we really don't have the money 

to fund your Program anymore. If you can bring in your own money, fine. Or if the New 

Mexico Department of Agriculture will take you on, you can continue. Otherwise, you 

are not getting any more money from us. So thankfully, Secretary of Agriculture Jeff 

Witte agreed to take us on along with the Director of the Marketing Division, David 

Lucero, even though they had absolutely no budget to take on our Program at all. So we 

feel very fortunate that we have a good home under the Department of Agriculture, which 

is under New Mexico State University, which is about three hours south of here, which 

means all of my bosses are about three hours away. So that works out pretty well. 

Crowd: [Laughter] 

Brett Baker: I would like to introduce a couple staff members. First is Craig Maple, who was our 

coordinator. Craig was on the commission, our Board of Directors for many years. He 

has helped us through this change. He is really invaluable in getting us into the 

Department of Ag. and keeping us there. 

And also Joni Quinn. Joni is our education Department, basically. When our legislation 

was written by Jay Friedman, it said that we would have an Education Department, 

someone who could answer the questions that a certifier is not allowed to. So when 

people ask me a question that is more than a “yes” or a “no” answer, they are directed to 

Joni for any help in meeting their corrective actions, non-compliances, anything like that. 

And I don't think he is here right now. Martin Sanchez is our newest reviewer, certifier. 

Oh, there he is. Good morning, Martin. Martin has been with us for a little while now. He 

is a certified organic farmer as well as inspector/reviewer and certifier. 

I want to say welcome, everyone. If there is anything anyone needs, information, 

directions, whatever, please call on any of the department staff. Again I want to thank the 

Board for being here. This is my first time at a NOSB meeting because we were always 

too poor to send most of us anywhere out of the state. So thanks for coming. Thank you.

Crowd: [Applause]

Barry Flamm: Thank you very much Brett. Next on our agenda is the NOP report. Miles 

McEvoy, please.
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May 22, 2012

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Miles McEvoy: Okay. Good morning again. I have a lot of things to cover. So I think I will just 

get started. Why don't we go with the first slide here? We have about 1.5 hours for this.

There are 4 parts to this particular presentation. And after each part I'm going to stop and 

ask if the Board has any questions or comments about each a section of the presentation. 

There is a lot of things here. I will try to take my time, but there's a lot to cover. So the 

first part is about the National Organic Program. What we have accomplished, what we 

are planning on working on. The next part, National Organic Standards Board, the role of 

the National Organic Standards Board, a lot of information that we have, that we have 

learned recently, about the Federal Advisory Committee Act and how that relates to the 

NOSB. Next, how we can best utilize our limited resources that we have in the Program

and the limited resources that the Board has in terms of time and energy as volunteers. 

And then finally how we can work together to achieve common goals. Next slide. 

So the National Organic Program is responsible for oversight of the global organic 

system. There are 93 certifying agents. We have four recognition agreements and two 

equivalency arrangements. There's about 30,000 certified organic operations around the 

world in 133 countries. We are responsible to ensure all those operations, all of the 

certifiers, are complying with the USDA organic regulations. Exports are really 

important. We've been working on acceptance in foreign countries for USDA organic 

products. We have the new US/EU organic equivalency arrangement to open up markets 

for organic producers and handlers in the US. And then for imports we have to ensure 

that all imports that come into the US meet the USDA organic regulations. Next slide. 

A little bit about the 2011 accreditation audits. We did 29 audits in 2011. We had 93% 

compliance with all the criteria. We have a new system in place where we identify all the 

various criteria within the regulations in the certification and accreditation sections, so 

there is many, many different data points on the requirements that certifiers have to meet. 

We did 11 domestic certifiers and 18 foreign certifiers and recognition agreements last 

year. And we looked at all of the various audit reports and found some common problems 

that certifiers are having. They include incomplete organic system plans, that is, that 

certifiers are accepting system plans that are not complete. Organic certificates that lack 

required information. That some certifiers were not adequately identifying operations 

non-compliances when they had identified those in the field. Not taking follow-up action.

And then, not submitting required information to the National Organic Program. These 

are all, for the most part, correctable issues that we identified most commonly. For 

certifiers, we are developing corrective action plan to continue that concept of continual

improvements so the certifiers can improve their process. 

And so for 2012, next slide, we have a lot of audits that are occurring this year. More 

than 50 audits that will occur this year. This is a renewal year. The first set of 

accreditation was issued in 2002. They are renewed every five years, so this is the second 

cycle, 2012. The focus this year for all of those audits is pasture rule implementation, 

grower group certification, materials review and approval process to ensure that there is 

consistent application of that through all of the different certifiers that are operating 

around the world, conflict of interest provisions that they have in place, and then their 

compliance procedures. We really want to make sure that all certifiers are following the 
Meeting Of The National Organic Standards Board

May 22, 2012

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same compliance procedures so that when they do identify non-compliances, corrective 

actions are taken and they are resolved, or that the suspensions or revocations are done 

appropriately and timely when necessary. So audits are occurring in many foreign 

countries, China, South Africa, Egypt, Mexico – you can read the list - and over 25 states. 

What we have been doing is expanding the number of witness audits that we do. Instead 

of just going to the home office and operations close to the home office, we will be doing 

witness audits in many different countries and many different states where the home 

office of the certifier is not necessarily located. 

Next, going to talk a little bit about OIG audits and the peer review process. These are 

really important for the Program to continue to improve the quality of their services, to 

protect organic integrity. It ensures that the NOP is meeting the requirements under the 

Organic Foods Production Act, and so I'm going to talk briefly about these different 

reviews that are going on. 

So the Office of Inspector General, we have three audits that I will cover: the 

comprehensive 2010 audit, the organic milk audit that is partially complete, and the 

National List audit that is underway. And then also the National Institute of Standards 

and Technology that is doing the peer review.

So for the first audit, this is the comprehensive audit I have reported on before. It was 

conducted in March of 2010. It looked at many aspects of the Program including 

compliance and enforcement, our oversight over state organic Programs and certifying 

agents, and our statutory requirements under OFPA. For this audit, all the corrective 

actions are complete including the peer review. There's only one outstanding item and 

that is removing the FACA requirement from the peer review part of the National 

Organic Regulations. So that's in process. 

The second audit is on organic milk. The scope there is to evaluate whether milk 

marketed as organic meets USDA organic requirements. The Phase 1 findings were 

released this winter. It had four findings. One was around GMO testing, which I will talk 

a little bit more this afternoon about during the GMO Subcommittee report. List of 

certified operations: the OIG identified that the Program had provided more transparency 

in terms of the list of certified operations that is on the NOP website, but that there is a lot 

of room for improvement for that list. The list is a point in time of a list of certified 

operations. And as soon as it’s published, it is out of date. So you can find operations on 

there that are no longer certified, or you can find certified operations that are not on list. 

So improvement needs to happen there. The need for unannounced inspections and 

handling of bulk commodities were two other findings. And this is where the Board is 

very important in terms of the work of the OIG audit and the work of the Program is. We 

have already made recommendations on these two different areas. And so, with those 

recommendations and with the information from the OIG audit, it makes it easier for us 

to implement those recommendations. And Phase 2 of the organic milk audit is underway 

so we'll have findings of that later this year. 
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May 22, 2012

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Next we have another audit that is underway on the National List and the National 

Organic Standards Board. So they are evaluating the process for adding substances to the 

National List of allowed and prohibited substances. The findings of that particular audit 

should be released relatively soon. 

Next we have the National Institute of Standards and Technology. So part of the audit 

from March of 2010 was that we had never conducted -- the National Organic Program

had never conducted -- a peer-review. So we contracted with the National Institute of 

Standards and Technology to do a peer review assessment of the Program. The first phase 

was completed last July. They had 28 findings and four observations. And our corrective 

actions have been accepted and we are just about ready to complete those corrective 

actions. 

Overall, NIST found that the NOP is designed to fulfill the requirements of the USDA 

organic regulations and that our actions are aligned with ISO 17011. ISO 17011 are the 

general requirements for accreditation bodies. So what we have done to address the 

findings from the NIST audit was: we revised our work agreement with the NOP

auditors, we have improved our web content, we've drafted proposed regulations to 

remove the FACA requirement related to accreditation, and we have improved control 

procedures for documents and records. 

A brief overview of the NOP budget for fiscal year 2011, just to give you some sense of 

where the money goes. We were appropriated $6.97 million, a little under $7 million for 

fiscal year 2011. This year we have a little bit less than that, $6.92 rather than $6.97. Our 

largest expense categories are $3.8 million for salaries and benefits. We have $1.6 million 

that are for contracts and agreements. And I will talk a little bit more about those 

particular contracts and agreements that we have engaged in. Almost $800,000 for 

agency overhead, which includes the Administrator's Office for Agricultural Marketing 

Service, our human resources, our support for human resources, the Congressional affairs 

office, communications office, civil rights offices, training, and IT. So there's lots of 

things that -- lots of uses that that $7 million goes to, not just directly into the NOP for 

our use. We have overhead expenses. And we have about $175,000 for other USDA

services, for facilities, lights, power, mailroom, security. And then about $165,000 for 

travel, which includes the travel for the Board.

So in terms of contracts and agreements, a lot of the contracts and agreements go to 

support the work of the Board. Technical reports for the NOSB - a couple hundred 

thousand dollars for that. The NOSB public meeting webcasting is a contract that we 

issued. Hotel contracts and transcripts for the NOSB are part of that money. The NOP

Appeals Staff is separate from the National Organic Program, so we fund the NOP 

Appeals Staff, which is 2.5 people. We had a contract for permitted substances list that 

we are hoping to publish later this year that will provide a permitted substances list for 

crop inputs. We are currently doing an economic impact analysis for the animal welfare 

recommendation from last year to see what the economic impact is on the organic poultry 

industry. We have an organic literacy project we are doing and will be rolled out to 

USDA later this year. This is where we are providing information about certification in 
Meeting Of The National Organic Standards Board

May 22, 2012

13

the organic standards to other USDA agencies and field offices in particular, so that 

information about the opportunities in organic agriculture can be provided to farmers and 

handlers all over the country. So we are very excited about that particular project. We 

have an inspector reviewer criteria development project that we hope to provide further 

instructions to certifiers about the criteria for inspectors and reviewers, the qualifications 

that they need to have. And then we are working with NCAT, the National Center for 

Appropriate Technology, which has the producer/handler workbooks that will be 

updated. So lots of things going on through those contracts. 

So accomplishments for the Program, in terms of accreditation and international 

activities, we continue to do audits of domestic and foreign certifying agents. We 

established the trade partnership with the EU. We streamlined our trade of ruminant 

livestock products to Canada. We demonstrated that the pasture rule meets or exceeds the 

Canadian stocking rates. So that now, for ruminant livestock products going into Canada 

under the Canadian equivalency arrangement, they no longer have to demonstrate that the 

stocking rates are being met. As I said, we have aligned our accreditation processes with 

ISO 17011.And we have revised our audit checklist on certification to include all the 

various components of the certification and accreditation criteria. 

In terms of -- next slide -- compliance and enforcement, as of the middle of this month, 

we completed 162 complainant investigations which is 26% more than all of last year. So 

we made a lot of improvements in terms of our timeliness of closing those complaints 

that come into NOP compliance. We have issued $54,000 in civil penalties this year. We 

published nine fraudulent organic certificates online. And we continue to have our efforts 

to streamline investigations and make enforcement more effective. So a lot of things are 

going on in compliance and enforcement. We have a new Director of our Compliance 

and Enforcement Division, Matthew Michael, who comes from FSIS. And he has got a 

lot of experience in conducting investigations and bringing a lot of that experience to the 

National Organic Program and things are going really, really well there. We've also 

worked a lot with our NOP appeals team and reduced the appeals time from 698 days --

was the average time period from the filing of an appeal to the issuing of the appeal 

decision, that was in 2009 -- down to 256 days in 2011. So great improvement there, but 

we are not done yet in that regard. We hope to get down to about 90 days as the target 

over the next couple of years, for appeal decisions. We really feel like this is important to 

get those appeals decisions done as per OFPA. It says “an expedited appeals process”. So 

we will continue to work on improving in that the area. Next slide. 

In terms of standards, we have implemented the pasture rule. We have new policies on 

GMOs, textiles, and residue testing. And we have published many things, many National 

List amendments, and guidance to implement the National Organic Standards Board

recommendations: Sunset 2011 final rule, crops and handling materials, Sunset 2012 

proposed rule; vitamins and minerals proposed rule, parasiticides proposed and final rule, 

methionine and tetracycline proposed rule. So lots of things are going on in that arena.

And then in terms of NOP-wide activities, we have improved our website and 

communication. We have the NOP Organic Insider that is now a standard part of our 
Meeting Of The National Organic Standards Board

May 22, 2012

14

communication strategy. And then we have also increased participation in the organic 

certification cost share Programs over the last couple of years by 20%. More organic

producers and handlers are now participating in that Program and getting the cost share 

assistance that they deserve. 

Okay. Now moving on to some of the challenges that we face, some of the things we 

have identified as challenges. One is geographic. If you look at a map of the United 

States and the number of certified organic operations, you can see that some states, 

there's a lot of adoption of organic agriculture. California, Washington, Wisconsin and 

New York lead the pack. But then if you look at the southeast part of the US, there's 

many states that have very little adoption of organic agriculture or certified organic 

agriculture. And there's no lack of markets in the South. Organic markets are very strong 

in the retail category in those states and the cities in that region. And there's no lack of 

great farmland. So what are the barriers that are there that are not allowing farmers -

organic farmers - in that area to participate in the opportunities that organic offers? We 

would really like to address that to see if we can get more adoption of organic agriculture 

in the South. 

Next challenge that we have identified - next slide - is not applying the standards 

uniformly. We see this when we do the audits of certifiers -- that certifiers are still 

making different decisions in terms of implementing of the standards. So we still need to 

work on consistency in terms of how the standards are applied in this global system. Next 

is lack of data. As we work on our rulemaking and our guidance, we really lack a lot of 

data on the number of operations affected and the economic impact of the rulemaking 

that we are conducting. It is really an impediment for us to move quickly with our 

rulemaking is that lack of data. Insufficient technology in terms of -- as we identified in 

the OIG audit -- insufficient technology of our list of certified operations is out of date.

We really need to ramp it up a bit in terms of information technology. And finally, we 

have limited resources. We have -- the US is in a tough budget times. It is really difficult 

budget scenario in Congress. And so we have a $7 million budget. We cannot get it all 

done. We are getting a lot done, but taking on more activities is really challenging. 

So we have four initiatives that kind of summarize where we are heading around clear 

standards, consumer protection, market access, and information technology.

So the first one is around clear standards. We think that this is essential in terms of 

fairness and transparency, to level the playing field. So continue our work to publish clear 

standards. Address those gray areas, in terms of implementation and ensure consistency. 

Ensure our continued collaboration with the National Organic Standards Board to clarify 

those gray areas. And make sure that this is a transparent process throughout. 

The areas of focus that we have are residue testing - getting our final rule out on residue 

testing. Origin of livestock is a priority - to get that out this year in terms of a proposed 

rule. We are working on getting the permitted substances list published for crops. Pet

food, aquaculture, apiculture, and mushrooms are other practice standards we would 

really like to move forward. 
Meeting Of The National Organic Standards Board

May 22, 2012

15

The next major initiative is around consumer protection, which leads to consumer 

confidence. This is really the core of the whole system - the organic regulatory scheme. 

We need to protect the integrity of organic products, whether they are grown locally and 

sold locally or grown in a foreign country and enter into the global organic market. 

Continue our rigorous inspections and investigations. Conduct more audits. We would 

really like to initiate a market surveillance Program. Enhance our enforcement actions. 

And ensure terms of our trade partnerships are being met. In terms of enforcement 

actions, just to make you aware, that in the Farm Bill that the Senate has adopted, there 

are a couple of amendments that are being proposed to the Organic Foods Production Act 

to provide stop sale authority and subpoena authority to the Programs that would enhance 

our ability to take enforcement actions. And, of course, we have no comments on the 

Farm Bill, but just to let you know that that is out there. 

Market access is really key to provide economic opportunity. We think of market access 

not just in terms of market access to foreign markets, but market access for local and 

regional farmers to get organic products into their farmers market, into their local and 

regional stores. Why in the South is there plenty of organic products being sold, but those 

farmers are not – or don't have access -- to the market. What are the barriers? Why are 

there very limited certifiers -- local certifiers -- available in the South? What information 

do they need to overcome those barriers -- to be successful in getting into the organic 

market? So we want to enhance our USDA technical and financial assistance. We do 

want to continue to provide access to foreign markets as well. We feel that's important. 

And we want to make the organic certification process accessible to all in the US.

Affordable so that small and medium-sized farmers can afford it. And attainable so that 

we don't make the process so difficult that people cannot attain the certification. 

And finally, information technology, which we believe it is very much tied to organic 

integrity. We do have a list of certified organic operations on the website. We get a list of 

all the certified organic operations from the certifiers once a year. And it takes us a little 

while to put that together into a comprehensive list. There's a lot of great information 

there. It's actually a searchable spreadsheet, so if we go to the next down arrow, if you 

were a producer in Alabama, and you were interested in organic livestock production and 

you were looking for organic hay, you could put in the state of Alabama and hay and you 

would come up with two producers. So there is two producers you could potentially 

identify. The next slide shows this farmer in Alabama, let's call him Marcus. What kind 

of questions would he have? So I'm looking for organic hay. I want to get in organic 

livestock production. I found this list of certified operations. But what do I need to know?

I needed to know whether or not -- next -- is this operation still certified? Since we get 

this list of certified operations one time a year, it is already out of date when we publish 

it. So they would have the question, whether this operation is still certified? Have they 

been suspended or revoked? And whether or not they have any organic hay available? So 

we really want to work on this organic database. Next slide.
Meeting Of The National Organic Standards Board

May 22, 2012

16

So this would better connect the organic community, a modernized database. Provide 

historic and current information on the certification status. We would like to display the 

search results in list or map-based formats. And allow certifying agents some kind of 

interface so that they can efficiently provide updates, and that this could be a real-time 

database. 

For example, with a map, you could list the particular operations that are currently 

certified, where they are located. But we would also like to provide information on here,

what certifying agents are available in this region. How do you get in touch with the 

organic certification cost share Program? What kinds of organic input supply companies 

are around, or what kinds of market opportunities are there? So, there's a lot of things that 

we could do through this database that could provide more information, and make it more 

accessible to protect organic integrity. 

So the benefits: enhanced oversight of certifying agents; increased transparency. We have 

a number of separate spreadsheets currently on our website. We would integrate all those 

different spreadsheets into one source. And streamline the certification process,

especially for export markets. We could provide export certificates in a timely fashion for 

Japan, Korea, or the European Union. 

Okay. So those are the four areas that are our initiatives: clear standards, consumer 

protection, market access, and information technology. And we do that to level the 

playing field, protect organic integrity, increase the number of organic farms and 

businesses, and connect the organic community via integrity.

So that's the end of the first section. Any comments or questions from the Board on what 

the Program is up to? Could be a chance to get a drink of water here. 

All right. So we will just move on to the next part. What is the role of the National 

Organic Standards Board? This is what we will talk about the Federal Advisory 

Committee Act. Next slide. 

So the Organic Foods Production Act establishes the framework for the National Organic 

Program, and the National Organic Standards Board, the roles and activities. It 

establishes the NOSB to assist in developing the proposed standards for substances for 

use in organic production and advises the Secretary on other aspects of OFPA. It 

establishes the National List, which is based on proposals from the National Organic 

Standards Board and it outlines the NOP and NOSB roles. 

So a brief history of the Board: It is a very active, self-empowered organic community. It 

existed before the Organic Food Production Act. OFPA was established in 1990 but there 

was little funding, initially, to support the work. There was a tough learning curve faced 

by both the NOSB and the USDA in establishing the National List and the NOP role. 

USDA had a lot of cynicism about the organic community. That has changed 

dramatically over the last 20 years. But when I started, for instance, at the Washington 

State Department of Agriculture in 1988, there was a lot of jokes about organic 
Meeting Of The National Organic Standards Board

May 22, 2012

17

agriculture. Things have really changed. We've really come a long way, that organic 

agriculture is very well accepted within both the federal and state departments of 

agriculture. So I would also like to say that this is the 20th anniversary of the National 

Organic Standards Board. I would just like to read off the names of the original National 

Organic Standards Board. Craig Weakley, who just retired recently from Cascadian 

Farm/Small Planet Foods; Don Kinsman; K. Chandler; Dean Eppley; Margaret Clark

from Washington State; Merrill Clark from Michigan; Michael Sligh, that might be here 

somewhere -- Michael, thank you for your service; Nancy Taylor, who unfortunately 

passed away earlier this year, which is quite sad. She was from Utah and Idaho. She 

actually worked as an inspector for Washington State Department of Agriculture for a 

while. Rich Theuer, who might be here as well. Maybe later. Bob Quinn from Montana;

Tom Stoneback; and J. Friedman, who helped to start the New Mexico Department of 

Agriculture’s New Mexico Organic Commodity Commission. Thank you for their service 

and thank you for the new Board and all the time in your service as well. Okay. So where 

was I? So as NOP implemented the rules, -- let's step back a minute.

So the NOSB recommendations have often been viewed as default answers by the 

organic community, especially in the '90s, as the Program was being developed. And as 

NOP implemented the rules, the focus shifted more and more to the NOP and certifying 

agents. And we have formalized the process. In this phase, NOSB worked on many issues 

but NOP really lacked the resources to respond to many of those things. So you saw the 

development of many, many NOSB recommendations that the Program just did not have 

the resources to implement. And at times the National Organic Program released 

directives without adequate input from the NOSB or the organic community, and that led 

to community conflict. 

So now we have a new balance. There's increased funding for the Program, which allows 

better management and rulemaking. There's more frequent and structured communication 

between the NOP and the Board. We provide regular feedback to the National Organic 

Standards Board on your recognition and the management support for your work. We 

regularly request your advice on materials issues and practice standards and we want to 

continue to do so. 

So our current challenges are that industry growth and new technology options have led 

to increases in the number of public comments and to public scrutiny. The rulemaking 

and guidance implementation is very lengthy and resource intensive. And it is getting 

more and more so. The process of getting things through clearance is just – it takes a long 

time. There's a lot of people we have to satisfy to get the NOSB recommendations 

implemented and through the rulemaking process. The NOP and the NOSB are both 

governed and overseen by many offices and interests. The NOSB activities and NOP's 

management, we must comply with the requirements of the Federal Advisory Committee 

Act, as well as with OFPA. 

So the Federal Advisory Committee Act: what is that? It governs how all advisory 

committees provide advice to the federal government. It has specific requirements. It

requires that advice is objective and accessible to the public. It provides for the 
Meeting Of The National Organic Standards Board

May 22, 2012

18

government-wide oversight of those advisory committees. And it establishes a framework 

covering the creation, management, operation and termination of those committees. The 

goals of FACA are to enhance public accountability. Requires balanced committee 

membership to control undue influence, and to maximize public access to committee 

deliberations through public meetings, and through the public comment process. Another 

goal of FACA is to reduce wasteful spending, to monitor and reduce costs, to reduce 

redundancies, and to maintain accountability of this process through our annual report of 

accomplishments. So we have to report back to the FACA folks every year on the 

accomplishments of the Board. 

So FACA defines a committee as any committee, Board, or other similar group, which is 

established by statute for the purposes of obtaining advice or recommendations. So we 

call it the National Organic Standards Board, or you are also an advisory committee. So 

you will notice on the agenda that we have changed the standing committees to the term 

“subcommittees” because committees in FACA language equals -- has certain 

requirements, has certain standing. All committee meetings have to be public, have to be 

accessible to the public. So that's why we are now, from this point forward, going to be 

calling the previous NOSB committees “subcommittees”. Functionality-wise, it is going 

to work the same way. But we are just going to call your previous committees 

“subcommittees”, because the National Organic Standards Board is a committee under 

FACA. So, federal advisory committees exist to advised and recommend and not to 

decide. So your job here is to advise and recommend actions for the National Organic 

Program in relationship to OFPA.

So, does FACA conflict with OFPA because OFPA has specific requirements as well? It 

does not. OFPA does not direct the NOSB to decide. OFPA asks the NOSB to assist in 

the development of standards, to provide recommendations, to evaluate substances, to 

develop a proposed National List, and proposed amendments to the list for submission to 

the Secretary. The Secretary retains that decision-making and rulemaking authority. 

So government oversight of the NOSB is through the Government Services 

Administration, which administers FACA. At USDA, we have a dedicated Committee 

Management Officer that oversees all the advisory Boards, all of the federal advisory 

Boards, at USDA. And we are held accountable to that group for the governance of the 

Board, for the activities of the Board, and for the budget of the Board. 

Our responsibilities are to establish uniform administrative guidelines and management 

controls, maintain systematic information on committee operations, exercise control and 

supervision over committee management Program, and make sure that the advice of 

committees is not inappropriately influenced. 

Our responsibilities, through our designated Federal Officer – and Michelle Arsenault, 

the Special Assistant to the Board is the designated Federal Officer for the Board -- is to 

call, attend, and adjourn those committee meetings, to develop and approve agendas, to 

maintain those required records and budgets, to ensure efficient operations and adherence 
Meeting Of The National Organic Standards Board

May 22, 2012

19

to FACA and other laws, and to develop committee reports for the Committee 

Management Officer. 

So the success factors: Our success is measured in part by our success in managing the 

National Organic Standards Board. Are Board and Program resources being used 

effectively and efficiently? Is the NOP asking for advice that it can then act upon? It 

wastes time and resources for the Board to work on items that we cannot implement. So 

we really want to collaborate and work very closely with the Board and on the work plan 

of the Board, on the agenda of the Board, so that we can work together to build the 

organic sector, to build the National Organic Program. And then finally, are appropriate 

management structures and processes in place and are they functioning? 

So, a little bit about the budget for the National Organic Standards Board. There’s

$190,000 for direct NOSB expenses in our budget. That covers the salary for our 

Advisory Board Specialist and the travel for Board members and staff. There are 

additional expenses that are related to the Board as well: The meeting contracts and 

transcripts, the technical reports, which is quite a bit; Webcasting; and all of the staff 

subcommittee support that we provide to all of the subcommittees. So all in all, there's 

quite a bit of our budget, of our $7 million budget, that goes to the -- to support the work 

of the National Organic Standards Board. Very critical work, very important work for the 

success of the Program, the work that you do. But we want to make sure that we are 

collaborating on that work to make the best use of our limited resources and to make the 

best use of your time, which is also limited. 

Okay. So FACA meeting rules: open meetings are required with the opportunity for 

public comment. Meetings must be announced 15 days in advance in the Federal 

Register. The meeting minutes are required and have to be publicly available. And the 

meeting must be accessible. 

Ethics: Board members speak for “we” not “I”. They represent and are appointed to 

represent the points of view of recognizable groups: growers, handlers, consumers. It is 

expected that members will represent a particular bias, driven by the group that they 

represent, not by your personal views. So try to keep that in mind as you're deliberating 

on these very important matters: to keep the perspective of your particular group in mind

as you deliberate. Members must disclose interest for any specific votes and abstain from 

voting where conflict exists. 

Some of the key roles for the Board: provide recommendations to the Secretary regarding 

the Organic Foods Production Act, develop the proposed National List or proposed 

amendments to the National List for submission to the Secretary, convene the technical 

advisory panels to provide scientific evaluation of materials. This is something that has 

not been done for a while by the Board. It’s something that I think would be really 

important for the Board to take up again, the creation of these technical advisory panels. 

Specifically, review botanical pesticides, which is in OFPA, and then advise the 

Secretary on product residue testing for unavoidable residual and environmental 
Meeting Of The National Organic Standards Board

May 22, 2012

20

contamination and emergency spray Programs. Those things are all outlined within 

OFPA. 

In terms of the National List: The National List is established by the Secretary, shall be 

based on the proposals developed by the Board. The proposals must be published in the 

Federal Register with public comment period. This notice must include any changes to 

the proposed list that is provided by the Board or amendments that are recommended by 

the Secretary. The NOSB also establishes procedures for how people can petition the 

Board for evaluating substances for inclusion on the National List. So that is also your 

responsibility, to establish those procedures around the petitions process. 

Your activities and parameters: National List activities defining the petition process, 

considering proposed substance petitions, proposing new National List items to USDA, 

that is your responsibility, and completing the Sunset evaluation process that you must do 

every five years for all substances that are listed on the National List. Key parameters 

within OFPA: a quorum is defined as the majority of the NOSB members. And then it 

also talks about decisive vote: that a two thirds of the members present is a decisive vote. 

We will go into that in a little more detail in a moment here. And then it also spells out 

the criteria for evaluating substances for the proposed National List or proposed 

amendments to the National List.

Okay. So that was a lot about FACA. I will stop there and pause. Are there any questions, 

comments, on this section? 

Barry Flamm: Colehour has a question. 

Colehour Bondera: Yes. Thank you. Yeah, it was a lot and I don't know that I feel that I'm totally 

adept to inquire, but I'm curious about some of what may or may not be easier issues 

which are: you laid out some of the budgetary topics and -- I don't know if you can 

clarify more. I have two questions. One is, you said that there is $190,000 that's – sorry 

I'm not going to get the word right -- but is direct expense. But then you said additional 

expenses. And you referred to, in what you presented, that it was “quite a lot”. But I 

wanted to have a better sense of if it was - just to get a scope of the whole picture - if I 

get a better sense of those additional expenses that are incurred. 

Miles McEvoy: Right. For budgeting purposes, we budget $190,000 for the Board. USDA has 

limits on how much money it can spend on advisory boards in general for the whole 

department. And the National Organic Standards Board is a significant amount, of that 

total amount, that is allocated by the federal government, by USDA, for advisory boards.

So there are additional costs, additional time that also goes into supporting the Board. 

Besides Michelle on the subcommittee calls, there are NOP staff members that sit in on 

all those subcommittee calls to provide technical assistance, to do some background work 

for the subcommittees as necessary, to provide you all with the information that you need 

to make good decisions. So there's that cost. There's the cost of the technical reports, so 

that is a separate contract not included in the $190,000. I think we spent – Lisa what was 

it? - about $200,000 for technical reports from our last year's budget? Webcasting and --
Meeting Of The National Organic Standards Board

May 22, 2012

21

I can't remember the other part, but there are other costs as well. We figure somewhere 

between half a million and $600,000 total cost to support the Board, which is a 

significant part of a $7 million budget. But really, it is a very critical part of this whole 

public-private partnership, the Board. We really rely on your work, so it is important for 

us to invest in good deliberations, good decisions so we can move forward with the 

Program. But there is cost involved in supporting that work. 

Colehour Bondera: Yeah. Thank you. That gives me a better sense. And leads to my second 

question, which was: You said that the NOSB could, as it has in the past, convene 

Technical Advisory Boards - that maybe we should be doing that - you alluded to that in 

what you were saying. And I'm curious - again from a financial perspective - is there, 

since we don't have a budget, we don't, I don't feel -- from my perspective -- it's like, 

well, is there money to be convening Technical Advisory Boards? And who is doing 

that? Where that fits into this whole picture is a little bit unclear, at least to me. I don’t 

know. I have not discussed this with people. I would like it if you would address that a 

little bit more detail. Thank you. 

Miles McEvoy: Yeah. If the Board wanted to restart technical advisory panels, there would be a 

cost involved, but we already have a lot that are invested in the technical reports. We also 

are working with the Agricultural Research Service in terms of them providing assistance 

in terms of peer review of the technical reports to ensure the quality and completeness of 

those technical reports. There might be some ability of USDA working with the 

Agricultural Research Service to help to convene technical advisory panels. So I don't 

think you should get hung up on the cost of implementing a technical advisory panel. 

Because first you would want to scope out what it would look like. But it is an important 

part that was envisioned within the Organic Food Production Act that there would be 

these technical advisory panels that would be feeding in information to the National 

Organic Standards Board to provide you with better, more complete information so you 

can make your final decisions on the National List. 

Colehour Bondera: Thank you. 

Barry Flamm: Are there any other Board -- Jay has a question for you.

Jay Feldman: Thank you, Miles. Thank you for your comments and interpretation of the statute. I 

particularly appreciate the emphasis on collaboration with the Board and the need to 

work together in moving the Program ahead on behalf of all of the stakeholders that have 

a real interest in seeing organic grow and seeing it grow with integrity. 

One of the elements, one of the elements that you mentioned, which I think is key to our 

better understanding of the responsibilities that we have in carrying out the statute, is this 

overlap or cross authorities of the FACA law and the Organic Foods Production Act. And 

you pointed out, rightly so, that this Board has specific statutory authorities that are 

distinct from, and perhaps complement and may amplify, the FACA statute. 
Meeting Of The National Organic Standards Board

May 22, 2012

22

And one of the things that the statute talks about, which Colehour mentioned just now, is 

the authority of the Board to convene technical advisory panels, which is an important 

authority and I think goes back to some of the history, that you yourself mentioned, in 

terms of the recognition that was afforded the organic sector back when the law was 

established. And that lack of recognition in some circles, and that today has been 

corrected, and now we see much more acceptance and support from USDA and from 

state agricultural agencies. But nevertheless, that was envisioned by the drafters and by 

Congress as an authority that was vested with the Board. To, by virtue of convening, to 

essentially direct how those technical panels were put together, who served on them, 

what their backgrounds are, whether there are conflicts of interest, the range of issues that 

one would bring to a deliberative process around the act of convening. So I think the 

Board, in my view, should exercise that authority. And I would like to ask the Chair of 

the Policy Development Committee to put this on the work plan in terms of figuring out 

ways to exercise that authority in a collaborative spirit with the Program, which is key to 

the statute working. 

The other element that you didn't mention, which I was surprised not to hear you 

mention, is the section in the law that is entitled “No Additions to the National List”, 

which I know you are familiar with. I just want to make sure the Board is aware that in 

addition to this authority that the Board has. And if we are to do our job, we find we 

spend a lot of time on this, and that is making proposals and recommendations, as was 

stated, to the Secretary on the formation of this National List. But there is a key limitation 

there, which is very distinct to the NOSB. And you will not find in other FACA

committees, that I'm aware of any way. And that is that there's a limitation on what the 

Secretary's authority is with respect to the National List. And that is just to read this, just 

so that I don't misinterpret it, I will read the language to you. “The Secretary may not 

include exemptions for the use of specific synthetic substances in the National List, other 

than those exemptions contained in the proposed National List or proposed amendments

to the National List.”

So those proposals obviously come from this Board and the Secretary may not create 

exemptions from that list. What flows from that is pretty substantial authority to manage 

that list. Now, we can make a proposal, the Board can make a proposal to add something 

to the list and the Secretary may choose not to add that substance. But the Secretary may 

not remove something that we have added to the list. Or, no, I'm sorry. The Secretary 

might not add something that we have not proposed for the National List. And please 

correct me, I will stop in a minute here, but please correct me if I'm wrong in terms of 

this interpretation. I just want to make sure that as we move forward and as we carry out 

our responsibilities, vis-à-vis work plans and agenda items to carry out our statutory 

responsibility, which is unique to this Board, that we have sufficient authority to manage 

that list in a way that enables us to hear from the community of people that we represent 

in our various sectors, and carry out that statutory responsibility as it was intended by the 

lawmakers and the public that got behind it. Thank you.

Miles McEvoy: Yeah, you are absolutely right, Jay, I’m going to cover that in the next part of the 

presentation.
Meeting Of The National Organic Standards Board

May 22, 2012

23

Barry Flamm: Zea has a question for you, Miles.

Zea Sonnabend: Thank you, Miles. My question has to do with what you said about the FACA

Board as it relates to what you said about the OIG auditing the National List procedures.

And will the OIG audit be oriented towards NOSB procedures or only how the NOP

implements NOSB recommendations in terms of rulemaking? And along with that, do 

you expect that to come out before the next NOSB meeting in the fall?

Miles McEvoy: Yeah. I actually can't provide any details because we actually don't have the 

details. We know the report is going to be out fairly shortly. It will be out before the next 

Board meeting. And we will certainly share it with the Board as soon as it is available,

but I don't have any details that I can share with you.

Zea Sonnabend: But will the corrective actions be only for NOP to correct, or will the NOSB

have to take up some of the things that are in there to correct our procedures? Do you 

have any idea?

Miles McEvoy: We don't know what the findings are yet, so we can't, I can't, provide you with 

any information at this time. 

Zea Sonnabend: Thank you.

Barry Flamm: Are there any more questions from the Board on this part of the presentation?

John has a question for you, Miles.

John Foster: Thank you. Miles. On your areas of focus that are coming up, there's a pretty long 

list there. Can you help us understand how those are prioritized? How you prioritize 

those? Apiculture first, or aquiculture first, or mushrooms, or...? What are the criteria 

that you make those priorities?

Mile McEvoy: We have lots of areas of focus. I wasn't sure if you are talking about we are 

focusing on for accreditation audits or ...? So you are talking about for standards 

development specifically?

John Foster: Not necessarily, although that was my main point. We can focus on that. Standards 

development prioritization would be great. 

Miles McEvoy: How do we prioritize? Ah, that is a good question. We try to listen to the various 

stakeholders, the Board ... So, there's a lot of different factors. So let’s just look at that 

list of items that we have for prioritizing standards development. The residue testing rule 

is a priority because that's part of an OIG audit. It was a finding from an OIG audit that 

we were not meeting a requirement under the Organic Foods Production Act. So that 

goes was up to the top of the list. That is why that's at the top of the priority list.
Meeting Of The National Organic Standards Board

May 22, 2012

24

The origin of livestock is at the top of the list because we know it's really, really 

important to a large segment of the organic community. We have a recommendation from 

the Board from years ago that we know we want to move forward as quickly as possible. 

The rest of those items on the list, we pretty much tried to date order them from the oldest 

NOSB recommendation forward. But you will see that they are not quite in that order. So 

it has to do partially with resources and the size of the economic opportunity for 

developing standards in those particular product categories. And Melissa has something 

to add here on that.

Melissa Bailey: Thanks for the question, John. I would also just add to what Miles said in that a

number of our priorities are sort of driven by the nature of the National List, of course. So 

we've been heavily involved in a lot of Sunset work over the last year. Any work that has,

sort of, a time-sensitivity to it. So things with expiration dates really jump to the top of 

the list and push down a lot of those other priorities just because of the time sensitive 

nature. So I think Miles will also address expiration dates a little bit later in the 

presentation.

Barry Flamm: Are there any other questions from the Board on this portion of Miles’

presentation? Jay has a follow-up question, Miles.

Jay Feldman: I was hoping someone else might ask this, but... First of all, I want to preface, 

Miles, what I'm saying with extreme happiness and enthusiasm around the strength and 

growth of the National Organic Program. It's institutionalization within USDA and the 

work that you're doing and the Program staff are doing with respect to implementation of 

this law. But you heard the “but” coming, right?

Crowd: [Laughter]

Jay Feldman: One of the things that I'm hearing – and it is sort of a subtext of what you have 

been saying in this presentation -- is that somehow in carrying out our work plans and in 

thinking about the decisions the Board makes, the NOSB makes, that we should 

recognize that the Program has financial challenges, and budgetary restrictions in terms 

of how it can move and so forth and so on. And I certainly, I hope, you believe that I 

appreciate that struggle and that limitation and that I'm sure all of the other Board

members do as well. 

I want to get your thoughts on this, because I think it's something that we have to be clear 

about. And that is whether this Board, in carrying out its statutory duty to propose 

changes under all the procedures that we have in place, including annotation process 

under the Sunset reviews, whether we should consider issues of budget and financing 

within the Program when we are deliberating on a particular action that we think is 

necessary to carry out our statutory responsibilities as a Board. And I raise this because it 

has come up in your talk today and also in other discussions that we've had. And my 

feeling is that that would be outside the purview of this Board. That our Board has a duty 

to evaluate these based on the standards and statute and that is as far as we go. We hand it
Meeting Of The National Organic Standards Board

May 22, 2012

25

off to the Program. The Program is then in a tricky spot. We recognize. And that goes to 

the question of budget allocations. 

I close saying that, in talking with people in other agencies on this very question, where 

we all know we are struggling as a government to meet obligations and so forth, that the 

one thing I hear over and over again is that, where Programs have statutory duties to 

fulfill, the government is very sensitive to funding those Programs. Because the 

government recognizes that they are vulnerable to litigation should they not meet their 

statutory duties. So I want to put that on the table because we will have a lot of issues 

coming up over the course of this meeting, as you know, that obviously affect the 

Program's use of funds and prioritization and so forth. But I just wanted to get your 

perspective on whether you thought it was appropriate for this Board, the NOSB, to 

curtail its decision-making in any way relative to budgetary issues. Thanks.

Miles McEvoy: Yeah. I wouldn't use those particular words, but I think it's very important for 

the Board, if the Board wants to be successful in terms of implementing your 

recommendations, making them actually be implemented and followed by the Program

and implemented by the organic community worldwide, you have to keep in mind what 

our resources are and what is possible. 

We have a full plate. And a lot of things are not under our control. We have very good 

control over the accreditation process and the compliance and enforcement process. And 

we are making great strides in that area. But in terms of rulemaking, guidance 

development, there's a lot of other factors that come into play.

Office of General Counsel, they have limited resources for reviewing the things that we 

send down there. So that is the major bottleneck at this point is the Office of General 

Counsel just does not have enough attorneys to crank out the work. So they are slowing 

down the process. 

And then you have our ability to get things through the clearance process. There's only so 

much capacity that USDA has for rulemaking. And we get so many cards to play during 

any particular time period. We can't do it all at once. We have those limited resources. If 

the Board wants to be successful in implementing your recommendations, you should 

realize the capacity of the Program, of USDA, to implement these recommendations. 

Okay.

Barry Flamm: I believe that's all the comments for this section. If you want to continue on the 

next, Miles?

Miles McEvoy: Let's move onto the next section. The next section is how can we best utilize our 

limited resources? Perfect segue, Jay. Thank you. Next slide. 

So, a little bit about the process from work plan to rules. The work plans are the things 

that the Board develops. They are basically their agenda for what they are going to work 

on during the various sessions. So the NOP and the Board agree on that particular work 
Meeting Of The National Organic Standards Board

May 22, 2012

26

plan. Those subcommittees engage in the work of developing those work plan items. And 

they develop proposals. That takes between three and nine-months depending upon the 

particular issue. There are things that the subcommittees worked on this last few months 

that they decided not to bring to the meeting here in Albuquerque. And will most likely 

be on the agenda for the Providence meeting. Next slide. 

So next, those NOSB proposals from the subcommittees are posted for public comment. 

There's a public meeting. The NOSB considers those public comments that come in in 

written and oral form. Revises those proposals and votes, and makes a final 

recommendation. Those recommendations are then provided to the National Organic 

Program and USDA. And that takes about three months from the publication of the 

proposals to the final recommendation coming out. 

Next, we consider those recommendations and we respond to those recommendations. 

We engage in rulemaking for development of whatever is necessary, whether it's 

guidance or policy statement or proposed rule. And then anything that we would do, for 

the most part, would then come out as another proposal that would be subject to public 

comment. And then would be finalized to the rulemaking process or the guidance process 

based on that public comment. 

So rulemaking for National List takes from six months - if we are really pressed for time

for particular things, like we did with the interim and final rule on methionine - to eight 

years it took for moxydectin from a final recommendation to a final rule. 

So, the types of proposals that the Board comes up with: National List petitions, to add, 

remove, or change the listing for a National List. You also have Sunset proposals to 

determine if a current listing should be renewed, or whether it should be removed, or 

whether that should be amended. And then you have your non-National List proposals. 

So those are practice standards or clarification of the USDA Organic Regulations or other 

areas involved in implementing OFPA. 

So the process for the National List petitions is that you review the petitions for 

completeness. That is done in concert with the Program. You request a technical report. 

You review the technical report and the petition. The subcommittee develops and votes

on the proposal. We post those subcommittee proposals for public comments. Written 

and oral public comments are considered by the subcommittee and the Board. 

Then, in terms of decisive votes -- sorry for the small print here. But, in terms of National 

List petitions, a decisive vote is a two thirds majority. The Board votes to classify a 

substance as synthetic or natural. That would also require a two thirds decisive vote to 

proceed. The failure to obtain a decisive vote on classification would stop the process. 

So, if the Board fails to make a decisive vote on synthetic versus non-synthetic for a 

petition, the process would end at that point. You would have to go back to 

subcommittee, try to figure out if there's a way to get to a consensus on that or a majority 

vote. Not a majority vote, a two thirds vote. 
Meeting Of The National Organic Standards Board

May 22, 2012

27

Next, the Board votes to list, not to list or change the annotation or to remove the listing. 

That also would require a two thirds decisive vote to proceed. And then NOP considers 

the recommended action and responds with our intended next steps. We can accept that 

recommendation, we can further restrict the addition of something to the National List, or 

we could choose not to take the recommended action. And, Jay, as you pointed out, NOP

cannot expand the use of a substance without the NOSB decisive vote. Next.

So in terms of Sunset review, the NOSB reviews the history. The subcommittee may 

request a technical report. The subcommittee then develops a proposal. That is posted for 

public comments. The Board would then vote to renew, to change, or remove the listing. 

If the NOP cannot renew... let’s see. The NOP cannot renew the listing without a two 

thirds majority. If two thirds majority is not achieved, the listing would be removed.

Again, this is where the decisive vote comes into play on a Sunset material. If there's not 

a two thirds vote to relist, then that substance would not be... we would not have the 

ability to move forward to relist that substance on the National List. So NOP then again 

considers that recommended action, that proposal from the Board, and responds with our

intended next steps. We can either accept, further restrict, or choose not to take the 

recommended action, but we cannot add to the National List. 

Non-National List Proposals: The NOSB and the NOP agree on the work plan. The 

subcommittees develop the proposal. The subcommittee proposals again are posted for 

public comments. The Board votes to recommend action. Again it requires a two thirds 

majority vote for that decisive vote. And then NOP will take those recommendations 

under advisement, but we are not restricted to the recommended language or actions. So 

for non-National List recommendations, we are not restricted. We can change those 

recommendations based on other input. 

A little bit of data here. This just shows the number of petitions that have come in over 

the last 10 years. And you can see that there was a big jump in 2007. This was part of the 

Harvey lawsuit with the 606 materials. So I can't read the small print there, but lots more 

came in in 2007. And then you will see pretty much a steady number of petitions and then 

another uptick in 2011 in terms of number of petitions that are coming to the Board. 

The number of technical reports, there was a number in 2002 and then another uptick in 

2006 related to the Harvey lawsuit. And then you can see that a lot of technical reports 

have been done over the last two years. In 2011, it has some number there, what -- 30 

technical reports were conducted in 2011. So we are putting more resources into those 

contracts to provide more technical reports to the Board. 

Number of NOSB recommendations over the years. There was a peak in 2007. These 

were the 606 materials. And many recommendations -- where is that? Around 40 to 50 

recommendations per year? 2007? -- 63 recommendations in 2007 which is the high 

water mark. And as you know there still are many National Organic Standards Board

recommendations that we have not implemented. Mostly those are practice standards. 

They were working on them but again the limited resources come into play there. Next 

slide. 
Meeting Of The National Organic Standards Board

May 22, 2012

28

Just shows the Federal Register activity. The types of Federal Register notices that we 

have published from 2001 to 2012. We will have this PowerPoint available on our 

website later today, I believe. So you can get a copy of this later. Next slide. 

So from recommendations to final rule: So there's the step between when you make your 

recommendation to when the Program actually publishes the proposed rule. And that can 

vary a lot in terms of the amount of time. It can be six months for us to develop that 

proposed rule, or three years for fenbendazole, or it was eight years for moxydectin, from 

the time there was a recommendation to when we had a proposed rule out on moxydectin. 

And then the next stage is from proposed rule to final rule. On average for a National List

substance, that is 10 [sic]. For Sunset rules, from the recommendation to the final rule on 

Sunset, it's usually about three years and for non-National List recommendations, the 

pasture rule took nine years from the first Board recommendation to the final pasture

rule. And we don't actually have any other examples, which tells you something right 

there. 

So details are important. But so is the big picture. The Sunset process enables the NOSB

to review all materials on a five-year cycle. It's in the statute in terms of what's the 

responsibility of the Board. This is where we make our plea to the Board. That these 

additional expiration dates for National List substances present incredible timing and 

resource allocation issues for us to deal with in our rulemaking process. And we have so 

much work to do that we really would ask the Board to really restrict your use of 

expiration dates because of the extra work that occurs. We are not getting other work 

done. You already have a process through the Sunset review process to review these 

things on a five-year basis. Please restrict your use of that, of expiration dates, to that 

Sunset review process. 

And then think about strategic rulemaking. For instance, pet food. A recommendation 

from the Board from a number of years ago projected sales of organic pet food are $300 

million by 2015. We don't have any specific USDA organic practice standards for pet

food. National List annotation changes are important, but so are practice standards. We 

really want to get to some of this -- what we think are fundamentally more impactful 

work. The National List is really, really important, but give us some time to work on 

some of these other things as well. 

Okay. So that's a little bit about how best to utilize our limited resources. Any comments 

or questions on that section?

Barry Flamm: Jay?

Jay Feldman: Thank you. Thank you, Miles. As you know, I was hoping we could have a 

community-wide discussion on the effect of non-decisive votes on synthetic/nonsynthetic determinations at this meeting because I think there are a variety of opinions 

and insights that could be brought to the Program’s interpretation on how to carry out this 

exercise in a way that is most protective of organic integrity and/or the growth of organic. 
Meeting Of The National Organic Standards Board

May 22, 2012

29

And so I would urge that we put that issue on the work plan. Again, giving the Chair of 

the PDC a lot of work. 

But for the next meeting, because I think that we have, as a community, we have a 

problem with this. And the problem -- tell me again if I am misinterpreting the problem --

as I see it, that is, we have a lot of, from time to time, I wouldn't say a lot but from time to 

time, the Board is really dealing with issues of material allowance retrospectively. In 

other words, the material is out there. It has been used at one time. A MRO, a material 

review organization, may have said to a user that it was okay to use as a non-synthetic. 

And then had to re-, you know, there's new literature, new determinations, new 

information. And the MRO decided this is synthetic and it should go to NOSB. Or we are 

dealing with vaccines, or something of that nature, where we find out that there may be 

some GMOs in the mix. So it is suggested often by the Program that the NOSB take a 

look at this and effectively make a determination retrospectively on the use of those 

materials. 

So we have had situations where the Board cannot make a decisive vote, reach a decisive 

vote on synthetic/non-synthetic. And the question before the Board is: is the material 

non-synthetic? Which is always the default question, as you know, before the NOSB. 

And so the Board, failing to make a non-decisive vote - in this case on a material that is 

in commerce and being used - is a critical question because it is a question of on-going 

use. It was -- many of us believe it was the correct interpretation would have been to 

disallow the use of that material by virtue of a failed vote on determination of nonsynthetic. And so that creates a framework around which we, as a Board would know,

that we are moving forward. In this case, the Program took the position as I understand it 

that because the material was in use, the Program would allow the material to remaining 

use. Sort of the inertia theory. You know: A chemical in use without scrutiny shall 

remain in use? Unless the NOSB can reach a decisive vote on non-synthetic.

Miles McEvoy: Or you could say a natural substance in use would continue to be allowed in use 

without....

Jay Feldman: This is why I want the community discussion, because the Board was unable to 

reach a decisive vote on it being a natural. That's why...

Miles McEvoy: That's exactly how OFPA is set up. You did not make a decisive vote. It then 

means you did not make a decision, so it goes to the Program to make a determination

which we make every day on a multitude of issues, on materials every day. Certifiers are 

making those decisions every day. The Board's responsibility is to make -- your authority 

rests with when you make a decisive vote. You need two thirds of your members to make 

a decisive vote. What we have agreed to is that we will provide a document to the PDC

around this issue of decisive votes. And we will have further discussions of that with the 

PDC. But it's not on the agenda for this meeting.
Meeting Of The National Organic Standards Board

May 22, 2012

30

Jay Feldman: Right, I understand it's not. Here's what I'm hoping we can get to, Miles, and that is 

a better understanding of how the Program makes that decision. In other words, what are 

the criteria that are used?

Miles McEvoy: Yes

Jay Feldman: What are the determinations based on? So that I don't, as a member of the public 

and as a member of this Board, feel that those decisions are arbitrary and capricious? I 

don't believe, finally, I don't believe that just because a material is in use and the Board

cannot make a determination that the material should remain in use, whether synthetic or 

non-synthetic in that context. And so all I am asking for, and I hope we can get some 

consensus on this at some point, that we have a set of understandings as to the process 

that the Program goes for -- goes through, I should say -- when it is taking the authority 

on a question for which the NOSB could not reach a decisive vote. 

Miles McEvoy: Right. We will be going through that in some detail on the classification of 

materials tomorrow morning, which is based on the NOSB recommendation on 

classification of materials. We will be presenting that tomorrow morning. That is the 

basis of how we would make that determination. So we look forward to further 

discussions on that.

Barry Flamm: Any further Board questions on this portion of Miles' presentation? Would you 

like to proceed?

Miles McEvoy: Yes. Okay. Last part. I think this is a little bit shorter. So how we can all work 

together to achieve common goals. Ground rules for the meeting: All public and Board

comments must be respectful. No personal attacks. This is standard Board process. No 

interruptions from the audience while the Board is speaking. No interruptions during 

public comment. We allow the public to speak. No intimidation, profanity or any 

language or activity that threatens openness. 

This is a federally sponsored meeting. The meetings are managed using Robert’s Rules of 

Order with the caveat around decisive votes as per the OFPA requirements. The NOP

will intervene if the ground rules are broken, and may ask anyone who disrupts the 

meeting to leave. So we are many voices joining to form one community. Let's have a 

great meeting together. 

This is a public-private partnership. We commend the NOSB for their public service, the 

countless hours that you have devoted to the Board. We know how much work you do. 

We really, really appreciate it. We really rely on your recommendations for the success of 

the Program, for the success of the organic community. Your diversity of perspectives, 

this vigorous public debate, it really strengthens our outcomes, strengthens our 

community. So thank you for that. 

Just remember that the scope of organic is very, very broad. We have livestock feed to 

frozen beef skillets, apple seeds to hard apple cider, small local CSAs to large 
Meeting Of The National Organic Standards Board

May 22, 2012

31

multinational corporations. All have to meet the same standards. All have to live under 

the same standards. Whether they are here in New Mexico or in Ghana, or China, they all 

have to meet these same standards, this world of organic farmers, world of organic 

agriculture. Let's celebrate this diversity to help us all achieve something much larger. 

I just want to show a few slides from some of the audits that we've been on in the last few 

years. The next slide shows an organic cacao cooperative in Ghana. This is a group of 

150 growers that are part of a grower group. We arrived on the day that they were making 

their first organic sale to a European buyer of organic cacao. They are all very, very 

excited about this opportunity to enter into the organic market.

Next slide shows the truck that was being loaded up. Big celebration for this community

that gets to benefit from this organic market. 

The next slide shows the alternative. The alternative to organic cacao in Ghana is this 

young man or teenager, possibly, with a backpack sprayer spraying chemicals without 

protective gear. In Ghana, the government subsidizes fertilizers and pesticides to cacao 

growers to try to up production. They don't subsidize organic production. They subsidize 

non-organic production. And organic holds so much promise for environmental

stewardship, for getting toxins out of the environment. We really need to work on ways 

to promote and to support these kinds of efforts.

So next slide shows a young man, benefiting from the wonderful taste of fresh organic 

cacao. 

And the next, I have a slide of a Veterans Sustainable Agricultural Training Program in 

Southern California. This is a thing that Karen and Colin Archipley have started. Colin 

Archipley is a decorated Marine veteran, served three tours of duty in Iraq. When he 

came back after his third time there, his wife really did not want him to back a fourth

time. And they decided to by a small piece of land and get into organic production. They 

have developed this organic hydroponic system which produces a lot of organic 

vegetables using 87% less water than a non-hydroponic system in that same area. And 

then they really wanted to give back to the veterans in that community in Southern 

California. So they started this Veterans Sustainable Agricultural Training Program to 

train other veterans on how to get into organic agriculture, how to get into the organic 

food business. So they teach them how to do organic hydroponics, business planning, 

financial planning. And it's really a wonderfully inspiring story of getting more young 

and beginning farmers into organic agriculture. 

The next slide shows Mike Haynes, who was a homeless veteran. A lot of veterans suffer 

from post-traumatic stress disorder. And he certainly did. He was homeless for two years, 

participated in this Veterans Sustainable Agricultural Training Program, put together a 

business plan and now he has a successful hot sauce business that is part of the organic 

community. I think this is some of the things that really inspire me every day that I go to 

work of what we are all about in this organic community to really help build this organic 
Meeting Of The National Organic Standards Board

May 22, 2012

32

movement. So thank you very much and look forward to a number of good days of 

discussions. 

Crowd: [Applause] 

Barry Flamm: We will take a break now, recess until 10:15. Then we will begin our first public 

comment period.

[BREAK]

Barry Flamm: Our first public comment is by Alexis Baden-Meyer from Organic Consumer 

Association. And Jo Ann Baumgartner, Jo Ann will follow her. Alexis, would you 

proceed, please?

Alexis Baden-Mayer: Okay. Alright. So I am Alexis Baden-Mayer. I am the Political Director of 

the Organic Consumers Association. I appreciate the opportunity to present public 

comments before you. 

The Organic law is great. It is just not always followed and it is not being fully enforced. 

And unfortunately, in most instances, when the refusal to obey the law has been

widespread, the response from Congress, from the National Organic Program and from 

the National Organic Standards Board has been to change the law and regulations to 

match non-compliance rather than to strengthen enforcement. 

The most striking example of this was in 2005, when the Organic Trade Association went 

to Congress to overturn a federal court ruling in favor of organic blueberry farmer Arthur 

Harvey. 

Another more recent example is DHA and ARA. The National Organic Program admitted 

that these synthetics used in baby formula were illegally approved for use in USDA 

organic products. But instead of enforcing the law, which would have only meant 

changing the certification of these products to “made with organic”, the NOP asked the 

manufacturer to petition the products for placement on the National List, and the National 

Organic Standards Board approved them at the last meeting, even though it was clear that 

the NOP had not properly vetted DHA and ARA to determine whether they were 

produced using excluded methods of genetic engineering. 

Two more examples of the organic industry's refusal to obey the law, and the NOP’s

unwillingness to enforce the law, are open questions before you: GMO vaccines and 

animal welfare standards. Now I understand that you have tabled this issue, but I'm going 

to give my comments as prepared because I'm not exactly sure why you tabled. So I will 

just let you know what I think. 

Under the regulations, GMO vaccines cannot be used unless they are successfully

petitioned for use on the National List. To date, no GMO vaccines have been petitioned, 

so one would assume that they are not being used in organic. 
Meeting Of The National Organic Standards Board

May 22, 2012

33

In reality, we know that they are being used. This was first admitted publicly by the 

National Organic Program staff at the May 2009 meeting of the National Organic 

Standards Board. Richard Matthews announced to the Board that in fact, since the 

beginning of the Program, all vaccines have been routinely allowed in organic without a 

review as to whether or not they were genetically engineered. And he recommended that 

instead of the NOP enforcing the law against this violation, the NOSB should recommend 

a change in the law. And that is what NOSB did. 

Deputy Administrator McEvoy wisely rejected that recommendation, but the NOP still 

has not made any attempt to enforce current law. The NOP should have immediately 

collected information on which vaccines are used in organic, and informed certifiers and 

producers of which of those vaccines were genetically engineered. At that point, 

prohibited GMO vaccines that had been used in organic could be petitioned, and we 

would be back on track with the current law. 

Instead, the NOP seems to have left the ball in the NOSB’s court, and we still have an 

acknowledged failure to follow the law and to enforce the law. This is not right. I urge 

you all to stop your work on the GMO vaccine recommendation until you get some 

assurances from the Program that they're going to actually take steps to stop the illegal 

use of GMO vaccines. 

We have a similar issue in animal welfare. You all are trying very hard to establish some 

measurable standards for animal welfare. But the irony is that, while you try to improve 

animal welfare standards, the current regulation is being violated. The Livestock Living 

Conditions Regulations and Livestock Health Practice Standard Regulations – they are in 

my comments, and ... Okay. I am done. You can read those. But I encourage you to 

encourage the NOP to follow the law before you produce any more standards on animal 

welfare.

Barry Flamm: Thank you. Are there any questions from the Board? 

Jay Feldman: Thank you, Barry. Thank you, Alexis. I appreciate your comments. You put your 

finger on an issue that concerns me as well in terms of how we get ahead of the curve on 

issues of compliance. Have you had any direct communications with the Program on 

ideas of how they might enforce this? My understanding is it is complex – this I am 

talking about the GMO vaccine – it is complex in terms of even knowing what is out 

there in the market now, as you know, with proprietary control that these companies exert 

over their genetic engineering technology.

How would you suggest we move forward as a Board? In what timeframe? And what is 

your expectation on behalf of consumers as to what we need to do as a Board? I mean, 

obviously you know, we do not enforce the law. So that talking to the Board about that 

isn't that helpful in terms of our ability to set priorities. But, what you think the Board

should be doing next and in what timeframe?
Meeting Of The National Organic Standards Board

May 22, 2012

34

Alexis Baden-Mayer: I don't think the Board be acting on GMO vaccines except to encourage 

the Program to enforce the law. And I think to come up with recommendation after 

recommendation on this issue isn't very helpful. I think that the Program has the 

responsibility. And I understand that the companies that produce GMO vaccines don't 

want to explain whether their vaccine is GMO or not, but if they want to use it in organic, 

they need to. And it is incumbent upon them to prove that their vaccine is non-GMO

before it is used in the Program. So that should be the message of the NOP to the 

manufacturers of vaccines. And I think it is more honest, as a Board, to acknowledge this 

failure of enforcement and the law, rather than trying to help the NOP to put together 

some change in the law that would make enforcement easier.

Barry Flamm: Calvin, I believe you had a question for Alexis.

Calvin Walker: I do. Alexis, would you... what is your view on the Board having more time to 

digest complex issues like DHA, corn steep liquor, and others? Because many times, a lot 

of written comments are provided. We need more time to digest it because consumers put 

a lot of thought into writing. And we come to meetings and, as a new member - not as 

new as Tracy and Camilla and others - is that we hear expert testimony, consultants. And 

we have such a short time to actually vet or determine if this information is correct before 

we vote. Do you think your recommendation such as these need to be deferred after 

hearing oral testimony and then maybe, at the next meeting, bring those issues up for a 

vote?

Alexis Baden-Mayer: That is not a bad idea, I think you all should take as much time as you 

need, and gather the information that you need, especially on complex issues. I think that 

that would have been very helpful at the last meeting on ARA and DHA. If the open 

questions had been answered before the Board made a decision. And, as far as I know, 

there was... you know, you all are not under a deadline. These substances have to be 

properly vetted before they are approved for use in organic. And you can take the time 

that is necessary to do that.

Barry Flamm: Alexis, is there... Nick has a question for you, Alexis.

Nick Maravell: Yes, Alexis. You are recommending here that the Board stop any work on the 

issue of vaccines containing GMOs. You don't see any valuable contribution that the 

Board could make in cooperation with the Program to move forward on this issue? I am 

not quite sure what you are implying by “the Board should stop work” on this if this is 

indeed an important issue for the organic community.

Alexis Baden-Mayer: The law, as it stands, certainly protects organic integrity and it protects 

consumers. The law, as it stands, requires every single vaccine that is genetically 

engineered to be individually petitioned and reviewed by the Board. And we haven't seen 

that. And we know that there is an outstanding violation. And we know that many GMO

vaccines are being used in organic. And we don't know anything about them. And that is 

a very bad place to be. 
Meeting Of The National Organic Standards Board

May 22, 2012

35

And I think it is really important for the NOSB to acknowledge that. And I think that in 

2009, when the Program came to the NOSB and said we are violating the law, there 

should have been some measure of outrage. And there should not have been such an 

effort to change the law to help the NOP with enforcement. And, you know, the most 

recent recommendation is not offensive to me. I think it is in good faith and you are 

trying to figure out these things for producers. But I think that we need to enforce current 

law. And on something like this, it is totally jumping the gun to see how we can enable 

farmers to use GMO vaccines in emergency situations, where they might be needed,

when we don't even know which vaccines are GMO and the Program is not enforcing 

current law.

Barry Flamm: Thank you, Alexis. I don't believe we have any additional questions.

Nick Maravell: Do you have suggestions on ways in which the organic community can work 

with the Program and with the National Organic Standards Board to identify the very 

information you are talking about, and to move this issue further down the road in terms 

of resolving it and making it clearly legal, and clearly understandable to everyone? Do 

you have specific suggestions on who might participate in that?

Alexis Baden-Mayer: The manufacturers of the vaccines have the information that we need. And 

it is incumbent upon them to petition their vaccines that are GMO to the Board. That 

would be what would happen in a perfect world. That may not be what happens here. But 

I think that if that doesn't happen, if GMO vaccine manufacturers are not coming 

forward, then the directive from the NOP has to be “if you want to use a vaccine in 

organic at all, you need to show us that it is non-GMO”. So if they won't come forward 

with the information about whether it is GMO, we need to require each of them to prove 

that it is not.

Nick Maravell: That places organic livestock producers in a quandary. So we are trying to move 

forward in a way that is equitable to all sides. So I guess that’s what I am looking for:

some way in which the information can be collected, and better inform us as we try to 

make policy. I am not sure that the Program can require a manufacturer of a vaccine to do 

anything, if they don't want to submit a petition. So I am not quite sure how we are going 

to get there without cooperation. That is, I guess, what I'm saying is.

Alexis Baden-Mayer: I am not suggesting that we decertify livestock operations that are using 

vaccines for which we don't know the GMO status of. The proposal that I'm making is 

just that the current mess that we have be cleaned up. Not that anyone get decertified. Not 

that vaccines stop being used. Let’s just get into compliance with current law. I'm not 

asking for anyone to be punished for the non-compliance.

Barry Flamm: Thank you, Alexis.

Alexis Baden-Mayer: Thanks.

Barry Flamm: Jo Ann Baumgartner is the next speaker. From Wild Farm Alliance.
Meeting Of The National Organic Standards Board

May 22, 2012

36

Jo Ann Baumgartner: Hi. Oh, good. There it is. Hello, everyone. I am Jo Ann Baumgartner with 

Wild Farm Alliance. And I'm going to talk about biodiversity conservation in the NOP

rule. Next.

Biodiversity conservation is part of the NOP definition of organic farming. There is a 

major standard, 205.200, that says operators must maintain or improve the natural 

resources including soil, water, wetlands, woodlands, and wildlife. The preamble says 

farmers must initiate practices to conserve biodiversity. And twice the NOSB has made 

recommendations. The most current recommendation was for the NOP to 

comprehensively address biodiversity conservation. Next.

So, we, along with many others in the organic community, have come up with 

biodiversity guidance that we are proposing that NOP consider adopting and putting in 

the national handbook. It will help certifying agents. It will help farmers. It will help 

them with complying with regulations in crops, livestock, and handling. Next. This 

addresses the NOP stated commitment to biodiversity as a priority, and the NOSB

recommendations. Next. It is easily adopted. We use the same terminology as what is in 

the handbook right now. It gives definitions. It gives examples of actions that can be 

taken.

So, what is biodiversity? It is the inclusion of diverse flowering plants and habitat for 

pollinators and other beneficial insects. Next. It is conserving and restoring habitat like 

on this organic farm. Next. It is conserving wetland and riparian areas, sensitive areas

that need protection; planting diverse systems and pastures. Next. And rare seeds and 

breeds. Next.

There is also government information that is tied into this along with the NOP’s... it ties

into NOP’s model organic system plan. Next. And addresses land conversion. Next. And 

gives all of these other standards that address biodiversity. 

The other thing we want to talk about was accreditation. Next. We need the 205.200 

standard in the accreditation checklists, both this file review checklist. Next. And the 

witness checklist. It is missing. It would be really simple to include. So we would love to 

see the NOP consider that, and consider adopting and/or editing and adopting the 

guidance into the handbook. Thank you.

Barry Flamm: Jay has a question for you, Jo Ann.

Jay Feldman: Thanks, Jo Ann. Thank you for the work you are doing. Obviously, I am interested 

in how your work can be better incorporated into the work of the Program. And it sounds 

like you feel the handbook is adequate on many levels. I guess what I'm interested in is 

what actions, additional actions you feel are necessary to help promote the adoption of 

biodiversity guidelines or operations. And then what are the hurdles that a certifier faces 

when they are trying to enforce biodiversity guidelines or biodiversity practices as you 
Meeting Of The National Organic Standards Board

May 22, 2012

37

see it? And what should we be doing as a Board in terms of taking additional action with 

regard to all of this?

Jo Ann Baumgartner: First of all, I think the handbook would be much improved with the 

adoption of this guidance. But the most critical thing is to add the biodiversity standard, 

the 205.200, where “operators must maintain or improve the natural resources including 

soil, water, wetlands, and wildlife” into that checklist. Because that would mean that all 

certifiers across the board would be addressing this. Right now, there are several 

certifiers that do. And they have figured out how to build this into their programs. And 

they still have vibrant programs. Like CCOF is an example. As you know, they are the 

biggest certifier and they helped with this guidance. And I think it is fair to say they 

would like to see a level playing field for all certifiers. And that would move the issue 

forward significantly. And what would be great, is for the NOSB to look at the 

accreditation checklist and help make a recommendation to the NOP. 

Jay Feldman: Thank you.

Barry Flamm: Other additional questions? Thank you very much, Jo Ann. Our next speaker is 

Lisa Bunin. 

Lisa Bunin: Good morning. My name is Lisa Bunin. I’m the Organic Policy Coordinator at the 

Center for Food Safety. My remarks address multiple issues. 

GE contamination of organic: CFS is pleased to see the formation of a GMO ad hoc

Committee and we support its letter to the USDA Secretary Vilsack raising concerns 

about GMO contamination of organic. We agree with the letter's conclusion that the 

USDA's actions to date on GE crops have been insufficient to protect organic integrity. 

The burden for preventing GMO contamination continues to unfairly rest on the organic 

industry, even though the technology provides them with no benefits and only costs. We 

urge the NOSB to pressure USDA to require those who profit from GM technology to 

demonstrate whether contamination prevention is possible. This proof is essential to 

protecting organic integrity. 

GMO vaccines: CFS does not support the recommendation. We share concerns about the 

potential lack of non-GMO vaccines to combat a severe disease outbreak or an 

emergency. However, permitting the use of an un-reviewed GMO vaccine will not 

protect valuable livestock genetics if an unanticipated health problems arise as a result. 

There is a noticeable absence of peer-reviewed studies to demonstrate the safety of GMO

vaccines for humans, animals and the environment. Unfortunately, the TR fails to shed 

any light in this regard. A list of non-GMO vaccines and their uses must be published to 

prevent accidental use by farmers. GMOs are not seen as functionally equivalent by 

consumers or in the legal interpretation of the NOP regulations. We urge the NOSB to 

reject the proposal.

Aquaculture: CFS supports the development of organic aquaculture regulations for landbased, closed loop, recirculating systems. We do not support open ocean facilities like 
Meeting Of The National Organic Standards Board

May 22, 2012

38

those allowed in the new Canadian trade standard. Such facilities contravene OFPA 

because fish escapes are impossible to control, and because they disrupt natural 

ecosystems by releasing foreign matter, species, and disease into the ocean. CFS opposes 

harvesting wild fish to feed farm fish under any circumstance, as allowed by the 

Canadian Standard. Organic aquacultural systems must never compete with marine life

for food. It is ecologically unsustainable and inconsistent with the principles of organic. 

The courts have ruled that livestock must eat 100 percent organic feed, not wild fish. We 

urge the NOSB and NOP to develop organic aquaculture rules that truly support organic 

integrity and to resist pressure to make US rules equivalent with Canada's weak,

voluntary standards. 

Inert: CFS supports reviewing Formula List 3 by 2015, and developing a concrete plan

for reviewing Formula List 4, beginning with 4B which includes acutely toxic and 

endocrine disrupting chemicals.

Conflict of interest: CFS supports the proposal and urges disclosures by contractors, 

public communications. CFS supports the proposal and agrees that the Board benefits 

from stakeholder input in between meetings. And we support...

Biodiversity: We support putting biodiversity guidance in the NOP handbook and 

including biodiversity in the accreditation checklist. Thank you.

Barry Flamm: Thank you, Lisa. Before I ask Jay to ask his question, I have a request of the 

people that are scheduled to speak. If, when you are next on the list, if you would come 

up and sit in the chair right next to where Lisa was, that will help us out a great deal.

Male: [Indiscernible -- low audio]

Kathryn Grant: I’m right here.

Barry Flamm: Thank you, Kathryn. Again I... You were blocked out, so thank you. And the next 

person on the list, if you would be prepared to come up, that would be great. Jay, will you 

ask your question?

Jay Feldman: Yeah. Thank you. And thank you, Lisa, for your work and the work of the Center 

for Food Safety, and advocacy work on genetic engineering. I think what you, along with 

the community, did to advance this issue within the NOSB is critical to the process and 

shows that public input into this process is critical to the outcomes of the Board’s work. 

Thank you for that. On the aquaculture, I know you among many others on the consumer 

side are basically asking the Board to revisit a policy that was adopted – what? – 2008 or 

so. And I just wanted to get clarity because we have a lot of new Board members here. 

And there is a basic tenet under which many have operated in the past. And that is, you 

know, a previous policy should really not be revisited except under extreme, pretty 

extreme circumstances. And I would like to just hear if you think we have met that 

threshold of extreme circumstances that would require the Board to revisit it. That is the 

first part of the question. Second part is we are being asked by the Program to move 
Meeting Of The National Organic Standards Board

May 22, 2012

39

petitions for materials that would be used in aquaculture systems before we have actually 

seen the final rule on this and I was interested on your thoughts on how or if we should 

move in that direction.

Lisa Bunin: The 100 percent feed rule is definitely violated by the regulations. So I would 

definitely encourage this new Board to revisit that before really moving forward too 

much further in aquaculture. A 100 percent is legally required and so, allowing less the 

100% organic feed for aquaculture systems should not be allowed. And the second part of 

your question was about moving forward with materials. As you have seen in our 

remarks, we really are supportive of moving forward with aquaculture but in a very 

careful and measured way. And we believe that open ocean systems are detrimental to the 

marine environment. And we have said, submitted many comments on the record 

including resubmitted a list of escapes and what the potential effects are in the marine 

environment. We would recommend moving forward with land-based inland 

recirculating systems where they can be tightly monitored and tested and a trial system be

put in place to really get the system right. I think this is a really important new area and 

we want to make sure that organic integrity is upheld.

Barry Flamm: Thank you. Nick has a question for you.

Nick Maravell: Yes, Lisa. I have two questions. And you packed a lot into your presentation. I 

know we limit them to three minutes. So I was wondering if you could expand on two 

points that you raised with regard to GMO vaccines. One is: you said the un-reviewed 

GMO vaccines will not protect valuable livestock genetics - I see that as one half of this 

one question - if unanticipated health problems arise as a result. Can you extrapolate on 

that a little bit and say fully what you mean there?

Lisa Bunin: We have been looking for data to see really: has anybody really studied the health 

and environmental effects of GMO vaccines? And so they really haven't. And so I guess 

we would be looking for is some side-by-side comparisons where you took a look at a 

conventional vaccine and a GMO vaccine and maybe a control group. And there was 

some sort of... I don’t know if there is data that we are not privy to because it is 

confidential business information. But from the information that we have been able to 

obtain, we just don't feel confident that GMOs are safe. And we feel that, given that lack 

of information, it would be extremely inappropriate for the NOSB to recommend the 

allowance of GMOs even in emergency situations.

Nick Maravell: You anticipated my second question. I will just mention that the committee 

recommendation as it was formulated would not have changed any behavior on the 

ground in the event of an emergency. If the specific vaccine were required by a federal or 

state official empowered to declare an emergency, it is still going to be used under 

existing law or under the committee's recommendation. We simply were providing a 

different status of the resulting product which under current law would be declared not 

organic. Where did you look trying to find information on the health effects, the impact 

on the environment, the impact on humans, of GMO vaccines? Where were you looking?
Meeting Of The National Organic Standards Board

May 22, 2012

40

Lisa Bunin: Medical Journals. I had a list in my longer testimony. Animal husbandry journals.

You know, what we could get access to. But if I could just go back, and addressing what 

you were saying in the case of an emergency: I understand that there are certain laws that 

take precedence and, of course, under those circumstances, the Program has to agree with 

those laws. On the other hand, I keep grappling with myself, is how do we push back, 

particularly on the GMO issue to USDA or FDA to really take a harder look at the safety 

of these drugs for example, or GMOs in particular. And so that was why I phrased it that 

way in hopes that the NOSB would be proactive and aggressive in asking these other 

agencies to really take a harder look at the environmental and public health/safety of 

releasing GMOs that we do not feel have really adequately been studied. Thanks.

Barry Flamm: Thank you, Lisa. There is another question for you from Calvin.

Calvin Walker: You mentioned in your written comments Canadian aquaculture is not the best 

model. 

Lisa Bunin: No. Not at all. 

Calvin Walker: Could you recommend to us, the Livestock Committee, maybe a particular 

aquaculture regulation that may be pretty decent?

Lisa Bunin: I think it is the one that we are going to put together here. I really do not believe that 

there is anything out, that I have seen, that really does a good job of regulating organic 

aquaculture. And I really would urge you to begin with the inland, closed-loop, 

recirculating systems. And I think, if you do that, you are going to find that we are 

maintaining and charging ahead with the organic gold standard of the National Organic 

Program of the United States of America.

Calvin Walker: That is good. That is the same comment that Mr. Lockwood, that was his same 

response when we asked that question in the Livestock Committee. Thanks.

Barry Flamm: Is any other questions for Lisa? Thank you, Lisa. Katherine DiMatteo is our next 

speaker.

Katherine DiMatteo: Thank you. Good morning. My name is Katherine DiMatteo. Welcome to 

all the new members of the Board. And thank you for the energy and time commitment 

you give in service to the organic community as members of this National Organic 

Standards Board.

Wolf, DiMatteo and Associates is a small consulting business that has served hundreds of 

farms and businesses with their organic production systems and regulatory compliance,

both nationally and internationally. Our written comments and these oral comments are 

not made specifically on behalf of any one of our clients. But do represent the opinions of 

my partners based on our personal values and experiences, and on our work with both 

current and past clients. There is not enough time now to restate our written comments. 

So here are some of our overarching thoughts behind the comments that we have written. 
Meeting Of The National Organic Standards Board

May 22, 2012

41

The Inerts Working Group should complete its recommendations as soon as possible in

order to avoid confusion that may result from short-term solutions made in the absence of 

an overall policy on the approval of inert ingredients, and also to end the regulatory 

uncertainty that is disrupting the development of new inputs suitable for organic 

production. As well, the framework document, Classification of Materials, recommended 

by the NOPB, should move forward as NOP guidance before new discussion proceeds on 

solvents and extractants, and on the definition of insignificant, uh, of significant residues. 

We live in a polluted world. The proposal that any detectable level of synthetic is

significant is in direct conflict with the interests of the organic farmers. Allowed synthetic 

materials and natural materials that have long been used by organic farmers, such as 

adjuvants, pH adjusters, plant animal meals, botanical pesticides, beneficial microbial 

inoculants, compost, processed and raw material, uh, manures, mined rock minerals,

micronutrients, and plant extracts, would be lost and, in turn, would result in the decline 

of the numbers of organic farmers and acres in organic productions.

Substances that are formulated with other ingredients, synthetic or natural, and are 

reviewed during the petition process, can be and have been allowed on the National List. 

This approach should be continued rather than individual reviews of such substances. The 

organic label and NOP Seal are allowed on products with up to 5% non-organic, nonsynthetic, and synthetic substances. Don’t sacrifice the producers of the 95% organic 

ingredients by overzealous interpretation of review criteria based on personal opinion 

about the essentiality of the 5% substances, or other concerns that fall outside the scope 

of the National Organic Program, such as chemical sensitivities or allergies. 

The very existence of Certified Organic Farms, organic processing, the National Organic 

Program, and input and ingredient suppliers who provide compliant materials, has been 

continuous improvement from business as usual in the farm and agricultural product 

sector. Please provide them with the tools and time to build on what has already been 

accomplished and increase adoption of organic methods. Let's get beyond the 1 percent 

of worldwide agriculture that we currently have.

Barry Flamm: Thank you, Katherine. Is there questions for Katherine from the Board? I guess 

there is no questions, Katherine.

Katherine DiMatteo: OK. Thank you.

Barry Flamm: Thank you. Gang... how do you pronounce your name, Kristine [sic]?

Kristin Gangwer: [Laugh] It’s “Gan-gwer”.

Barry Flamm: Gangwer. Thank you. Excuse me.

Kristin Gangwer: [Laugh] No problem. My name is Kristin Gangwer. And I'm a consultant to 

agricultural non-profits and CSA’s in Albuquerque, New Mexico, where I also live. I’m a 
Meeting Of The National Organic Standards Board

May 22, 2012

42

member of the Cornucopia Institute and I'm here today as a citizen lobbyist. Today I'm 

going to read a proxy letter that thousands of individuals have now signed.

Dear Secretary Vilsack and Chairman Flamm,

The will of Congress, and the rule of law, has been ignored for too long in the 

management of the USDA’s organic program. This problem predates the Obama 

administration. But after the election of President Obama, we had hopes for “change” at 

the USDA.

We ask that you both immediately take charge of investigating improprieties at the 

National Organic Program and address the following problems and issues:

1. Based on intentional misinformation provided the NOSB, and incompatibility with the

Organic Foods Production Act, we ask that the National Organic Program return to the 

NOSB, for reconsideration, its recommendation approving Martek Biosciences’ 

genetically mutated algal and fungal oils, containing many synthetics.

The NOSB should remove carrageenan from the list of approved non-organic food

substances due to serious health and environmental concerns, including being classified

as a “possible carcinogen.”

3. The Technical Advisory Panel review of carrageenan, and a subsequent review at 

Sunset, took an industry-friendly perspective by ignoring well-documented health and 

environmental concerns. Because these reviews by agribusiness-affiliated scientists were 

not aberrations, we request that all future Sunset reviews be required to include new 

Technical Reviews, until the integrity of the process can be assured.

4. The process of choosing individuals or organizations to conduct future Technical

Reviews needs to be revamped to assure reviews by truly independent scientists. The

current contract with The Organic Center, an offshoot of the industry’s largest

trade/lobby group, must be immediately discontinued.

All future NOSB appointments should be made respecting the letter of the law and

congressional intent. Farmer board representatives must, as is written in the law, own or 

operate a certified organic farm. Further, the independence of NOSB members must be 

maintained by refraining from appointing farmers, scientists, environmentalists, and

consumers who are simultaneously employees of corporate agribusiness.

We call on the Secretary to immediately remove the new NOSB farmer representative

who in reality is a full-time employee of Driscoll Strawberry Associates, Inc. and replace

this individual with a legitimate farmer meeting the definition of the law. We have no

objection to her future appointment to a board seat reserved for a handler.

8. Recent rules reducing individuals of public interest groups to three minutes of public

testimony during NOSB meetings, and limiting direct correspondence with NOSB
Meeting Of The National Organic Standards Board

May 22, 2012

43

members, give corporate agribusinesses a disproportionate advantage, since they can

afford to be represented by numerous executives and lobbyists. Public participation

should not be shortened. The process should be more inclusive.

And, finally, two square feet for poultry outdoors, and other woefully inadequate animal 

husbandry recommendations, need to be revisited. 

Thank you for considering my concerns. I urge you to take action to prevent

embarrassment to the USDA and the organic industry, preventing organic stakeholders 

from being compelled to sue the USDA to enforce the law. 

And again, that was a proxy letter signed by thousands of individuals and I also thank 

you for your time.

Barry Flamm: Thank you for your comments, Kristine. Is there questions from the Board? Calvin 

has a comment for you, Kristine.

Calvin Walker: The proxy letter of a thousand individuals/stakeholders, are they all from New 

Mexico? What is the range in states?

Kristin Gangwer: [Inaudible] Fair enough. Yeah, sure enough, Mark.

Mark Kastel: I can help you with that, Calvin. There have been somewhere upwards of 20,000 

proxies. Dr. Joe Mercola put it on his website as his lead story to 22 and a half-million 

interested parties last Sunday. He gets 25 million visitors to his website, even more than 

the Cornucopia’s website. And so that would be from all over the country including this 

individual who signed it, thank you, from New Mexico.

Barry Flamm: Harold has a comment, a question for you, Kristine. 

Harold Austin: Kristine, one of your comments was about the appointment of individuals to this

Board that might represent larger stakeholder groups. Would they not still be considered 

a stakeholder?

Kristin Gangwer: [Inaudible] Yeah. 

Crowd: [Grumbling]

Mark Kastel: Thank you. Thank you. Ladies and gentlemen, I am going to take advantage of the

opportunity that this Board afforded William J. Friedman, the attorney for...

Miles McEvoy: Mark, it’s not your time. You need to sit down. Mark, you need to sit down.

Mark Kastel: To answer any questions, Miles, you allowed Mr. Friedman to come and ...

Miles McEvoy: You have your time. You need to sit down. It is her time.
Meeting Of The National Organic Standards Board

May 22, 2012

44

Mark Kastel: So the court... Don't touch me. Don't touch me. Thank you. You can argue with 

me. But, Barry, I’m going to appeal to you since you a chairing this.

Crowd: [Applause]

[Off microphone discussions]

Barry Flamm: Kristine, Harold would like to... Excuse me, Kristine, Harold would like to rephrase his question in a way to get your reaction and personal response.

Kristin Gangwer: Sure, and I am happy to respond to the question as it was posed before as well.

Harold Austin: Thank you and my apologies for putting you on the spot. Let me rephrase the 

question to go to your comments. Wouldn't it be, wouldn't you think it would be fair 

though to consider appointments for this Board or any other part of our organic industry

to consider all stakeholders and not limit specific stakeholders? Irregardless of size?

Kristin Gangwer: Sure and I am just going to speak to my understanding of the system. But in 

this situation, what this comment was addressing, I see as a certified organic farmers in 

that position being... they must own or operate a certified organic farm. And so I guess, 

for me right now, that is all I am really able to speak to. That this individual, as far as I 

know, does not actually farm. But any other questions, more detail, can definitely be 

directed to Cornucopia staff in their allotted time.

Harold Austin: Fair enough. Thank you.

Barry Flamm: Are there any other Board questions for Kristine [sic]? Greg Herbuck [sic] is our 

next speaker. Did I come close, Greg?

Greg Herbruck: Close. Good morning. I don't know how to follow that up. But thank you for 

your time. My name is Greg Herbruck. I am an organic and conventional egg producer in 

Michigan. Since the vaccine issue was withdrawn, I will just make a few comments 

that... As Nick had mentioned, please don't put egg producers and specific poultry 

producers in a tough spot by changing things in the middle of the game. We have an 

issue, for instance, we don’t... Vaccines are critical to life of the bird as well as the 

product they produce. For instance, an egg, we give salmonella vaccines to prevent 

infections that wind up in the egg itself and could wind up in the human food chain. And 

I hope that we are not using as a criteria down the road, a human illness infection as the 

time we could use this kind of a vaccine. So I would encourage that we move carefully 

and slowly, that we don't cause collateral issues on downstream. 

I would also like to bring up the methionine issue. I know there has been an agreement to 

move it ahead at a 2-pound static recommendation. I would encourage the NOSB and the 

NOP to consider recognizing, as they have done in many other times, the stage of life. A

bird does not need a static inclusion of amino acids in its diet when it is young. Coming 

into peak production, it has a much higher level. The static number does not fit. We are 
Meeting Of The National Organic Standards Board

May 22, 2012

45

under feeding. We are not meeting the birds’ needs for that stage of life. And so would 

strongly encourage recommendation that we consider it an averaging effect over the life 

of the bird.

And then, finally, I just want to conclude that I would elicit caution as we move forward. 

I have had the chance to travel a fair amount in Europe and watch, in looking at different 

systems that they have as far as the living system for the hens. And what I am seeing is 

organic is disappearing greatly. It is a miniscule portion of the commerce of egg

production in Europe anymore, because they have overdone some of these standards and 

restricted. And I just encourage caution that we move forward, that we don't wind up 

with the same thing here. Because in Europe, it is a very... it is disappearing very fast 

and I just don't want to see that happening here. Thank you.

Barry Flamm: Thank you, Greg. Mac has a question for you. Right here.

Mac Stone: What’s the... how you determine the regiment of vaccines? And is it different from 

your conventional versus your organic? And does the system that is in place create a 

different regiment?

Greg Herbruck: I'm going to let our veterinarian Mohamed speak to that later but, generally, it is 

a slightly different. Some of the same experiences, a bird dealing with viral infection 

risks we deal with are very similar. The bacterial is more significant in organic because 

the birds are in a cage-free environment, where they are in a more – we call it – dirtier 

environment. They are more exposed to agents in the environment and so it is a more

strict regime.

Mac Stone: With the outdoor access, does that change the regiment?

Greg Herbruck: Yes, it does in some degree. We had – we have not done it yet – considering a 

second possible killed salmonella vaccination just to further protect the chick, the hen and 

then the eggs it produces. Have not yet.

Barry Flamm: Nick has a question for you, Greg.

Nick Maravell: Could you just comment on the size of your operation? And whether or not you 

think there would be any value - if you can respond to this - any value in exploring 

autogenous or customized vaccines for your flocks that might be equally as effective as 

what you are using now?

Greg Herbruck: Some of these autogenous are very narrowly focused. And what you run into –

the problem is – some of the commercially available ones are designed for a broader 

spectrum, so you get a broader range of protection for the bird.

Nick Maravell: So you don't think autogenous vaccines would be appropriate for your operation? 

It would be specific to your operation. And could you comment on the size of your 

operation in terms of size of flocks?
Meeting Of The National Organic Standards Board

May 22, 2012

46

GregHerbruck: We have roughly 1 million organic hens and roughly 5 million conventional 

hens. And autogenous, again, it is a very focused. And again, I may defer to Mohammed,

who is going to be coming on later. He is our expert on that and can speak to the details 

of that situation.

Barry Flamm: Jean has a question for you also.

Jean Richardson: Yes, thank you for your comments. I do want to make it clear that we are 

interested in seeking input on GMO vaccines throughout this meeting. And it is important 

to us because, even though we have tabled a vote this week, I think it is reasonable to 

assume that we will try to come up with a good recommendation within a year. So my 

question to you is: have you read the TR? And, if so, are there specific areas where 

you've found error or specifics which you would like to draw to our attention at this time, 

especially perhaps with regards the avian salmonellosis vaccine?

Greg Herbruck: I think that would be... The main concern is that thinking of... Tthat we would 

be able to have some of these restricted vaccines in the event of an outbreak. OK? If it is 

an outbreak in a bird, then it is a localized. If it is an outbreak in a human population, we 

waited and... Are we putting ourselves and our companies at risk because we allow, we 

produced a product then. And then it is too late. And that was my comment there: on 

using a vaccine in the event of... petitioning for it after the fact.

Jean Richardson: Again, did you get a chance to review the technical report?

Greg Herbruck: Not all of it. No.

Jean Richardson: OK. Thank you.

Barry Flamm: Calvin has a question for you, Greg. [Inaudible]

Jay Feldman: OK, thank you. Apologies if I'm asking you to repeat something, but did you say 

that you are aware of using GMO vaccines in your operations?

Greg Herbruck: I am not aware. We are using what has been approved by through the organic 

certification with QAI. We submit our vaccine regiment to them. 

Jay Feldman: Okay. The proposal that was before the Board linked the use of the vaccines to a 

declared emergency. In your experience, have there been emergencies? Does that make 

sense to you, that linkage? And are there any examples of emergencies having been 

declared and by whom?

Greg Herbruck: Well some of... We worry about animal welfare and bird care. Would we wait 

‘til... I mean, the reason we give vaccines is to prevent disease. Do we want to wait ‘til a 

disease has caused illness and injury to a bird or a animal, and then wait... In the case of 

salmonellas, if the salmonella infection winds up in an egg, do we want to wait ‘til a 
Meeting Of The National Organic Standards Board

May 22, 2012

47

human outbreak? And therefore I think that we need... That was my point of caution, that 

we make sure we don't open ourselves up to a high risk situation, where we wait, we react 

instead of prevent. 

Jay Feldman: Thank you.

Barry Flamm: Thank you. Greg. I believe that is all the comments that we have.

Greg Herbruck: Thank you.

Barry Flamm: Liana Hoodes is our next speaker.

Liana Hoodes: Good morning. The National Organic Coalition appreciates the work of this 

Board and the NOP in clarifying definitions and adding consistency to the standards and 

the National List. This Program is one of the most exceptional at USDA, and OFPA is 

one of the most forward thinking pieces of legislation in all of government. 

However, the innovations and complexity inherent in the law and Reg.’s also present 

significant challenges in implementation. Ten years on, there are naturally issues that 

need clarification and prior decisions that may be inconsistent with the intent of the law 

or other decisions. This Board must not shirk from facing them head-on. And we indeed 

see that some of those tough issues are addressed here. 

It is the statutory requirement of this Board as well as NOP to complete this work. It is 

not unusual for government to claim poverty or politics for not getting the job done. But

it is up to citizens to continue to push for their interests to be met. Organic needs you at 

this critical time. Consider the law first and the regulation as a vehicle to its 

implementation. 

Aquaculture: Consider the whole organic system first. Implement the biodiversity 

guidance and checklist. Evaluate all synthetics and provide practical, consistent 

definitions across all categories, even if it calls for midcourse corrections - as it would in 

ARA and DHA, which we believe you must revisit, or for carrageenan, which needs to 

come off, or by refining Classification of Materials by tackling the issues of significant 

residues. 

In obtaining clear, scientific and consistent definitions and reviews, reformulations may 

be necessary and are welcome in facilitating increased organic commerce. Confusion and 

un-clarity of definitions around materials is bad for business. 

Please move forward on inerts and GMOs despite the fact that you may get push-back up 

the line. It is clear that USDA from the top does not want to do anything regarding 

organic and genetic engineering, so you must be the place to do it. Please clarify both 

definitions around excluded methods as well as the effects of GE contamination on 

organic. Send the Secretary your letter, clarify existing regulation, and set a course for 

keeping GE out of organic.
Meeting Of The National Organic Standards Board

May 22, 2012

48

Similarly, deal with inerts immediately. We understand the enormity of the task but 

through the years NOSB has been crystal clear that inerts must be reviewed. Use... 

Group them, but they each must be reviewed. Why the delay?

Many of us advocate for NOP in every budget and farm bill. And it is much better for the 

integrity of the label and all of organic that, having done the hard work to remove unsafe 

materials from organic, you are waiting for USDA way up the line to complete the 

regulation, rather than for this topic to languish. 

We must remind ourselves that organic is the only food or agricultural label with such 

demanding mandates as well as public transparency. Where our flaws are laid bare to the 

public, our only defense must be that the federal government has never embarked on such 

a task and it takes time to get it perfect. But we must show that we are on the road to 

continuous improvement, not that we are thwarted by those who may wish to destroy it 

through weakening or confusing the standards. 

In the end, organic is about the health of humans and the environment and it is the future 

for all of food and agriculture in the US. And thank you for holding that true. 

I just want to note that the yellow comments do have some additions from what we 

submitted to the docket in research priorities, significant residues, biodiversity standards, 

and conflicts of interest policy. Thank you.

Barry Flamm: Thank you, Liana. Board, questions for Liana? Colehour has a question for you, 

Liana.

Colehour Bondera: Yes, thank you, Liana, for your presentation and for handing this out. You 

potentially raised a second question for me, but I will stick to my first question and we 

will see. And my first question is somewhat general. I recognize that, in the amount of 

time that you are testifying, you can't get into much detail. But I guess it is seeking you to 

go into a little bit more detail potentially, even though it is not an easy question. Because 

you suggested or referred to the idea that the NOSB should, and this is not a quote, but 

should strive towards or be ensuring consistency in the various decisions we are making 

across the different recommendations and different topics. And I hesitate a little bit, as 

the chair of the Policy Development Committee to ask this, but do you have a more 

specific suggestion as to how that can be achieved? Or what actions we might strive to 

take? Or what, like I said, what policies we might have in place in order to go down that 

path?

Liana Hoodes: I think that inconsistencies have occurred through unclear definitions or moving 

forward - and not just this Board but through the first 10 years of implementation -

through making decisions without good definitions. So where you are able to define 

terms, then do it. Take that time to do it. And then don't be afraid to go back when 

materials come up for review, review them in light of your new, consistent definitions. So 

I am not sure it is a policy that the PDC takes. I think that it is to acknowledge that there 
Meeting Of The National Organic Standards Board

May 22, 2012

49

were some places, where definitions were not clear in previous years, led to decisions that 

are not consistent across different categories or whatever.

Barry Flamm: Jay has a question, and then Calvin.

Jay Feldman: Thank you. Thanks, Liana. Again, I appreciate the work that NOC is doing is 

doing on all of this and in the context of NOC being a brain trust, of sorts, in the organic 

community and crosscutting in terms of bridging farm-environmental consumer interests. 

I would like to focus my questions on the public engagement part, or the public 

communications issues, and ask you: how important you feel that is? We all, as Board

members, are aware that NOC attempts to communicate directly with Board members to 

share the expertise that makes up the coalition. Some Board members feel overwhelmed 

by that process of direct communication. The proposal on the table makes some other 

suggestions as well as mechanisms for receiving the kind of valuable information that 

NOC provides on an ongoing basis throughout the deliberations of committee work, or 

subcommittee work. So I guess my question is: can you shed some light on the 

importance or lack thereof of the recommendation coming out of the Policy Development 

Committee?

Liana Hoodes: Yeah. First of all, public participation is really important. And we haven't actually 

been communicating with the Board for that long of our history. We felt that we should 

not. And only in the past year or so have really stepped up communicating throughout the 

whole year and not just on the docket, because we felt that, when it came time for the 

comment period, it was a little too late for your decision-making. And so we have 

stepped in. But we actually think it needs to be institutionalized. 

There is a long history of industry having access in USDA and us advocacy groups have 

also stepped up our ability to have input. But everyone needs to be able to have that 

input. And so something like a continuous docket that is separate from the comment 

period would help. But it is crucial because there are so many interests. This is a big 

Program, as you know, and there are a lot of different areas that practical experience, as 

well as good science, would inform your decision-making. And how can you all be 

experts in all of these fields? So I think the more transparency for you receiving 

information the better. 

And, obviously, it must get overwhelming. So I would say that something like an open 

docket where you can have access to it might help. My feeling is the more consistency, so 

it is not that I know I can get to you, or that an industry member knows that they can get 

to you, but that a citizen knows they can get... That we all have the same ability to this 

and it needs to be there to help inform your decisions. I am trying to see if I said anything

- particularly in our written comments - that I need to reinforce. But we do really endorse 

your clarifications on public communication.

Jay Feldman: OK, I need to clarify something. I just want to put my glowing comments in 

context and disclose that my organization is a member of NOC, so said take whatever I 

said with a grain of salt.
Meeting Of The National Organic Standards Board

May 22, 2012

50

Liana Hoodes: [Laugh]

Barry Flamm: Calvin?

Calvin Walker: My remarks is just a comment. Again, I would like to express what you all do as

– NOC, Cornucopia, OTA – I’m just impressed when I read documents from the different 

organizations that I have named and have not named with so much thoughtfulness that 

you all have placed in the written comments to give to the Board. I guess my question 

would be: do you feel that, as a Board, are we adequately addressing oral comments 

because we have so much sometime coming before us before we make a decision?

Liana Hoodes: I think... I do really think it seems you are definitely addressing oral comments. 

I hope that you are able to be a little flexible in the amount of time that is given. Three 

minutes is just not enough to say very much. But I have been at NOSB meetings where it 

ran on until 9 o’clock at night. That is not acceptable either. So is there a way to say 

that... to look at the number of people who are commenting and say, OK, there is less 

than we thought; you can now all have four minutes. Okay, it doesn’t get in the Federal 

register that way. I am not sure how that all gets dealt with. But can’t there be a way for 

flexibility to add minutes and to have a commitment for a little bit more time when it is 

available. Three minutes is not reasonable. But the question and answers that you do I 

think really help to drag it out of us after we fast talked for 3 minutes.

Barry Flamm: Nick has a question for you, and then Jean, please.

Nick Maravell: Yes, Liana. Thank you for your comments. I have some questions about the 

GMO vaccine issue, specifically with regard to some comments that you were not able to 

make verbally, but were in your written statement. And you are suggesting that the 

NOSB and the NOP write to the Secretary of Agriculture. Oh, and, I wanted Miles to 

hear this, but it looks like... Well...

Crowd: [Laugh]

Nick Maravell: I’ll have...Who is standing in for Miles, because I am going to ask for a 

comment from the Program? Melissa, are you standing in? Well, okay. I will give you 

plenty of time. One is you are suggesting that the NOSB and NOP write to the Secretary 

of USDA and APHIS, the Center for Veterinary Biologics who registers vaccines,

requesting that there be mandatory labeling of all vaccines. I assume you mean 

mandatory GMO labeling of all vaccines. This is an issue that goes well beyond, that is 

an agriculture-wide issue. That is not... this is not restricted to just organic agriculture 

here.

Liana Hoodes: Right.

Nick Maravell: And I'm sure we, the NOSB, have that in our purview to advise the Secretary. I 

guess I would like to get a comment out of the Program whether or not this seems to be 

within the authority of the Secretary of Agriculture to make a mandatory requirement 
Meeting Of The National Organic Standards Board

May 22, 2012

51

across all agricultural areas that GMO vaccines be labeled as to their GMO content? You 

can duck or whatever you want, but I need to ask that and see what the...

Melissa Bailey: Sure, no. I can give you some sort of answer. If Miles wants to contribute to that, 

he can do that when he gets back. I think... So to repeat back your question, you are 

asking if the Secretary has the authority to require mandatory labeling?

Nick Maravell: Of the GMO content of the vaccines.

Melissa Bailey: Of the GMO ... for vaccines. I think what we would have to do from the 

Program’s perspective is bring that kind of question to both APHIS, probably through 

the... there is a biotechnology working group that is an interagency group at USDA, to 

see where their authorities lie. It is certainly not under the NOP’s authority. So I would 

not want to speak for APHIS specifically on that particular issue. But if that is something 

the Board wanted information on, we could certainly pursue and find that information for 

you.

Nick Maravell: Yeah, I think it would be a very useful piece of information to have, and maybe 

something that the ad hoc GMO Committee may want to consider as well. The second 

question...

Liana Hoodes: Nick, can I just comment on that? I believe it is the duty of every citizen of the 

United States to demand that our government label all GMOs. That would be GMO

vaccines and GMOs everywhere else. And therefore, I understand the difference that it 

may not be the purview of the NOP to be able to ask for that. But I do believe that it 

would then be the purview of the NOSB to be able to ask for labeling of GMO vaccines. 

And it is necessary that we demand of our government that there is GMO labeling at 

every turn.

Nick Maravell: The second question I had was your point was: require livestock producers to 

find out if any vaccine is GMO and certifiers to request that information. Do you have 

any indication that that is currently being done or it is possible or is not possible? What 

are you hearing from the field?

Liana Hoodes: I am currently hearing that it is not possible.

Nick Maravell: It is not possible?

Liana Hoodes: Yeah. There is not clarity that a particular vaccine is GMO or not GMO. It should 

be down the line, when we get all of this GMO labeling that we are going to get when we 

ask for it, that it happen. But it is not possible and, you know, we are adamantly against 

the use of GMOs in organic yet we presented to you some alternatives because we're 

really worried about the effect on farmers here of outbreaks and of what happens if GMO 

vaccines are not available in specific instances so we have sort of capitulated - gone a 

little bit both sides here - but it is really about, we don't want to cause problems for 

farmers. It is very serious and you have noted that to other commenters.
Meeting Of The National Organic Standards Board

May 22, 2012

52

Nick Maravell: We have gotten some indication at the Livestock Subcommittee level – I’m now 

informed – that some producers have been able to inquire manufacturers about but, 

generally speaking, that we have not found that as a trend. The third thing I wanted to 

raise is that you are suggesting the NOP should compile a list of all non-GMO vaccines 

and their use. I guess what I would like to inquire would be a comment from the Program

whether or not – and Miles, you missed the first half of this – but whether or not that is 

indeed a realistic request: that the NOP could compile, has the authority, and has the 

ability to compile a list of non-GMO vaccines and their use and appropriately update it.

Miles McEvoy: Ah, it is an interesting idea. My understanding is the way the vaccines are being 

utilized through brand-name products. And, in general, the Program has stayed away 

from any kind of any brand-name review. We leave that up to the certifiers and the 

material review organizations to look at specific brand names. We know that APHIS has 

a list of what they consider recombinant varieties of vaccines. But that does not easily 

translate into the commercial available varieties of vaccines that farmers use. So it is 

unclear exactly what it would be that you are asking. You are asking for a list of brandname product products that are non-GMO, or a list of vaccines that have not been 

genetically modified? And then providing that list of vaccines that are not genetically 

modified would only be part of the process, because from there then you would have to 

see whether or not they are part of a commercially available vaccine.

Nick Maravell: We haven’t gotten to commercial availability. [Laugh] Let me ask Liana, and 

Miles, if you would want to comment on this too. Would maintaining a list of brandname vaccines that did not contain GMOs, is that something that you think a material 

review organization might be able to accomplish?

Liana Hudson: I am not convinced. That seems like it is a hard slog for everybody to get this 

done. So, to start at APHIS and with what information they know and working down, I 

think is a better way to go. And to say that we can't figure out if there are GMOs in 

vaccines is not a reasonable answer for organic. We must find out whether there are 

GMOs in vaccines. So we have to propose a lot of different paths to try and get there. 

For the MROs, and I'm thinking of my own small certifier that I am on the Board of, it 

would be a really tough thing to do that - to require each one to do it - but I think it has to 

happen on a number of fronts. And we just can't say that we can't do it because that is not 

appropriate for organic.

Nick Maravell: Miles, would you like to comment on the appropriateness of a materials review 

organization maintaining a list, perhaps under contract from the USDA, that would 

evaluate materials specifically with regard to excluded methods?

Miles McEvoy: Well, that could be a very good way to go once you have the criteria set up so

that the material review organization knew specifically what they were looking for. So 

the best information we have currently is the APHIS list of recombinant varieties. And 

that’s... we need a lot more information to see how that can be provided to producers and 

certifiers to provide clear information. So, it just seems like there is a lot more 
Meeting Of The National Organic Standards Board

May 22, 2012

53

information that is necessary. The best information is the APHIS list, and it opens up a 

number of additional questions.

Barry Flamm: Thank you. Jean has a question for you, Liana.

Jean Richardson: Hi. I appreciate your very short, your concise verbal comments, and the fact 

that you also were able to give us additional yellow sheet of information. On the 

additional material you gave us, you have expressed concern over the use of gibberellic 

acid in post-harvest handling for bananas. And I would like to know a little bit more from 

you about that. Obviously, when the Handling Committee got the TR and they went 

through all the details, they would have spent a great deal of time working to come up 

with this recommendation that they are putting forward. And I wonder if you could 

provide me with some of the additional information you have which would lead to 

suggesting that it may have some human health impacts as a biologically active plant 

hormone?

Liana Hoodes: I refer you to the Organically Grown Company’s comments, but then also to 

Lynn Cody, will be speaking for NOC on gibberellic acid on Thursday. And she will be 

the person to talk to. And by the way, Nick, Harriet will also be speaking about livestock 

issues and GMO vaccines, and you all can ask Harriet. She is better at livestock stuff than 

I am. Those are two NOC folks who will be speaking later. Sorry to put you off on that.

Barry Flamm: Thank you, Liana.

Liana Hoodes: Thank you.

Barry Flamm: Patricia Kane is our next speaker.

Patricia Kane: I would like to thank the NOSB and NOP for the opportunity to provide these 

public comments. My name is Patricia Kane. I am the coordinator of the Accredited

Certifiers Association. We represent 43 foreign and domestic accredited certifiers, and 

we also have supporting members. 

We did submit written comments on various topics but I'm going to just touch on a 

couple of our comments. I'm also going to talk about GMO vaccines a little bit. I would 

like to thank the committee for withdrawing the recommendation. We would really like 

to have additional work done on this. We have also suggested that the NOSB, the NOP, 

and APHIS work together to provide some sort of list that is usable for certifiers and 

producers on this really important topic. We also do not want to have producers penalized 

by eliminating these tools. Since the recommendation was withdrawn, I'm not going to 

give any additional comment on that. 

We also commented on the criteria for materials review by material review organizations

recommendation. And we were in general support of the recommendation. We did have a 

question. On bullet 2, regarding the requirement that ACAs, or MROs obtain ISO 65 

accreditation, we would like to ask the committee to consider distinctions in the various 
Meeting Of The National Organic Standards Board

May 22, 2012

54

types of MROs. We feel there are three distinct types of MROs. One is an independent 

MRO that reviews materials and publishes a publicly available list of approved materials

- which is... and this activity is conducted outside of the scope of certification; ACAs

that conduct certification activities and also provide a publicly available list of materials; 

and then there are ACAs that review materials within the scope of organic system plan 

and do not offer a publicly available materials list. The ACA believes that the

independent materials review organizations and ACAs publishing materials lists should 

obtain ISO 65 accreditation. We also believe that requiring ACAs who only review 

materials in the context of an organic system plan should not be required to have ISO 65

accreditation in addition to their NOP accreditation. This is redundant and very costly. As 

written we believe the recommendation would require all ACAs to obtain ISO 65 

accreditation. In our written comments, we did have some suggested wording for revision 

of bullet 2, so we hope you can take a look at those. 

We appreciate and thank you for your work on these issues.

Barry Flamm: Thank you Pat. Does the Board have questions for Pat? Joe, please.

Joe Dickson: Hey, thank you, Pat. I don’t have a question. I just have a quick comment on bullet 

2. We read your written comment, and others like it, and we will be voting on a version 

of that recommendation this afternoon that does clarify the ISO 65 requirement to only 

apply to entities that publish lists.

Patricia Cana: Great. Thank you.

Joe Dickson: Thank you.

Barry Flamm: Jay has a question for you, Pat.

Jay Feldman: Thank you, Pat. I am interested in the 100% issue and this distinction between 

processing aids and sanitizers. Your comments in the, I guess, the response to the survey 

questions that went out, indicate this distinction that suggests that the sanitizers don't 

come into direct contact with food, whereas the processing aids are somebody... I guess 

they are referred to as transformative possibly, and do come into contact with food. I was 

wondering if there are examples of sanitizers where there is direct food contact and 

whether, in fact, that is not an accurate distinction, such as a chlorine dip or something of 

that sort.

Patricia Kane: I think that you probably need to talk to some of the certifiers that are here. I 

don't deal with this on a day-to-day basis, so I am not familiar with specific sanitizers.

Jay Feldman: Thank you for sending out that survey. It is very interesting.

Barry Flamm: Mac has a question for you, Pat.
Meeting Of The National Organic Standards Board

May 22, 2012

55

Mac Stone: Pat, kind of a follow-up to Jay’s referring to the survey: There was... several of the 

questions, the survey results were quite varied and lack of consistency, I guess, to say the 

least. How can we work with the certifier community to help develop a standard, if you 

will, that can get to the clarity to eliminate some of these of variances of the current 

interpretation? How do we work together as a Board, as a Program, as a certifier, 

community?

Patricia Kane: I think working through your, you know, your work plan and the process that you 

use, the topics that you are discussing. And we are really willing and able to formulate 

working groups. That is how we arrive at the comments that we submit. We have 

working groups. And we can provide you with information as you are going through the 

process before you come to, you know, the conclusion on a recommendation. Certainly 

the question you ask, how can you work with us to provide standards and consistency 

could be a working group discussion. And we could start that.

Barry Flamm: Any other questions for Pat? Thank you very much, Pat.

Patricia Kane: Thanks.

Barry Flamm: Mark Kastel is our next speaker.

Mark Kastel: Thank you, Mr. Chairman. My name is Mark Kastel. I am the co-director of the 

Cornucopia Institute. My message today is: party is over. Party is over. The systematic 

corruption, secrecy, violation of the letter of the law and the intent of Congress, in

reviewing synthetics and organics with the Board's concurrence, will end in here in 

Albuquerque. The blatant illegal stacking of the NOSB with agribusiness executives, 

consultants, and agents has to end or we are headed to court. Nominating a consumer 

representative from General Mills is illegal. Likewise, appointing agribusiness executives 

to the farmer slots when they do not, as OFPA requires, own and operate an organic farm 

is likewise illegal and a betrayal. 

Furthermore, under the last Board chairman, chairperson, going from public comment 

representation, affording five minutes a year ago to speak before the Board with an 

additional five minutes as a proxy down to a mere three minutes is a gross suppression of 

public input. Why do we at Cornucopia and other public interest groups need proxies? 

Who is in this room? Who is in this room every meeting? At the Cornucopia Institute, we 

have many imminently qualified organic leaders who have important contextual

information to share with the Board. Unlike corporate executives, consultants, lobbyists, 

lawyers, we do not have a travel budget underwritten by agribusiness. Among those 

speaking for corporations in the Martek case at the last meeting, as you recall, was a 

physician, in the best tradition of doctors hired by tobacco companies to contest the 

preponderance of published peer-reviewed literature. It was true that we challenged Dr. 

Alan Greene to identify his conflicts of interest. And we told him if he didn't, we would.

He registered to speak before you folks as a quote “public citizen”. And even though he 

was paid to appear by Dean Foods, he told the Board he was a consultant just answering 
Meeting Of The National Organic Standards Board

May 22, 2012

56

questions about DHA. In reality, he was doing promotional work for their brand. He did 

work for Mead Johnson in promoting DHA for Martek and their conventional infant 

formula, and even sold, partnered with Twin Labs selling DHA supplements under his 

name. 

Going forward, the NOSB needs to require all individuals presenting testimony to this 

Board, to fully disclose who they are working for currently and in the past. Who is paying 

the bills? During the Martek debate, after four years of research, Charlotte Vallaeys had 

three minutes to present her findings to you folks. With all the consultants and people 

they flew in, Martek and Dean Food had almost 55 minutes. Does the imbalance serve 

the Board in building your knowledge base necessary to make good decisions? I hope the 

Board members will ask our position on technical reviews because I am out of time.

Thank you very much.

Barry Flamm: Thank you for your comments, Mark. I believe Calvin had his hand up first for a 

question for you.

Calvin Walker: Mark, you asked that we ask you... your last statement. So what is your position

on TRs?

Mark Kastel: And we had it on our printed comments. I hope you will consider. The Martek 

situation at the last meeting was a wake-up call for Cornucopia. 

We never considered ourselves a quote “materials group”. We depended on other folks 

and now we are learning that there might have been biases involved. The technical 

review system over the last... during the history of the NOSB has been inappropriately 

influenced by the competition of this Board in reviewing. And I have already illustrated 

that some slots that are reserved for independent voices have been filled by corporate 

representatives.

But we need to demand that all the individuals producing the technical reviews are fully 

identified, not just, as I referred to, the testifiers before this panel who are giving expert 

advice, but the conflicts of in... First of all, this is being done in secret. We know the 

firms that the department is contracting, the Program is contracting with. We don't know 

the authors of the technical reviews. 

We have looked at this and have every reason to believe that we would all be disturbed 

by the identity of some of these individuals. So, number one, they have to be made 

public. Their backgrounds have to be made public and any conflict of interests have to be 

disclosed. 

Most importantly, OFPA gives the authority to secure technical reviews, not to the NOP

but to this body. Congress encharged you with making sure you are educated. This is not, 

with the exception of Zea, this is not a scientific panel. You have to be able to depend on 

the independence and quality analysis that is presented to you. The Board of Directors at

the Cornucopia Institute choose our auditor. Chase Bank, or whatever the whole 
Meeting Of The National Organic Standards Board

May 22, 2012

57

conglomeration is called now, their Board of Directors chooses the auditor, not the staff. 

So you folks need to vet those experts. You can collaborate, certainly, with the staff but it 

needs to be your choice and they have to be identified to you, identified with you.

The final thing on TRs, Calvin, is that because - if you read the organic Watergate 

document that we just recently made public - because of the fact that the authors all had 

an agribusiness relationship, some of them are still working as consultants, testifying 

before you on the issues that they have critiqued, I think it is very important to look back 

by requiring TRs on all Sunset-ing materials. The recent committee decisions, one of 

them suggested a material remaining on the list because no new information has come 

forward to contradict what was originally presented to the Board. Unless you do a 

literature review, unless you have someone do a literature review, how do we know if 

there is not new scientific basis, as in the case of carrageenan, that new, very serious, 

deleterious impacts to health or the environment have come to light.

Barry Flamm: Jay has a question for you, Mark. 

Jay Feldman: Mark, I have a couple of questions. But I just want to sort of address the Board

quickly on.

I appreciate the passion that you bring to this. I think there is a fine line between passion 

and disrespect and emotion and I think just, as you may be aware, some people are very 

uncomfortable with where that line is. I personally have experienced the passion in that

people that walk that line over the course of my responsibilities at my organization. So I 

have learned to wade through the weeds on issues of emotion and passion which I think 

are incredibly important to understand when we are dealing with the public. And I urge 

Board members to cut through all of that and get down to the kernel of the issues that are 

being discussed here because, despite that passion-slash-emotion-slash-disrespect that 

you might be seeing or feeling, that there is a lot of good critical important information 

that is being put together by a extremely capable staff that has spent hours and days and 

months researching issues in what I think is a very laudable way and scientific way. So I 

just want to put that out there because I know there is some discomfort among many, 

both in the audience and on the Board here. 

OK, so having said all that, I... You have been raising this issue of proxies which, up 

until very recently, was considered important to the Board’s functioning and hearing 

from the community. And I just want to hear your viewpoint on the whole proxy system 

as a part of public comment, and how important you may view that as a part of the 

process, and why it is important.

Mark Kastel: Sure. I actually think your first comments dovetail perfectly into that.

I want to really clarify for the Board and my fans out in the audience what this little

confrontation today was all about. 
Meeting Of The National Organic Standards Board

May 22, 2012

58

I talked about the fact that Dean Foods and Martek have the budget to fly in farmers, to 

fly in consultants, to have lobbyists and lawyers at this podium before you, whereas a 

public interest researcher did not have that availability. At one juncture in the last 

meeting, an executive was standing at this podium with Martek Biosciences Incorporated

and could not answer a question from the Board. I think, Jay, the questions you ask are 

probably more important than our testimony because it is the missing piece of the puzzle 

that you have to find to make your informed decisions. And since that executive could 

not answer the question, their lawyer William J. Friedman, walked up to the podium and 

said, I can answer that question, and did so. 

Now we don't have $400 an hour lobbyists. But we had in this case, and a few other,

volunteers that are organic stakeholders. And if the Board has a legitimate question, I was 

standing ready and prepared to answer that. Now when Miles came up to me - Miles, I 

said very respectfully, you are not chairing this meeting, Barry is - and that is why I went 

over to Barry. And Barry assured me that myself and the other Cornucopia staff members 

would have an opportunity to answer some of those questions after we do our 

presentation. I appreciate that opportunity. 

So the dovetailing into the proxies is that we have this leadership - I'm just going to 

mention a couple of people because I have presented proxies in the past and other 

Cornucopia staff members that presented from Goldie Caughlan, Bill Weish (who passed 

away last year I’m sure you folks know), Kevin Engelbert, and Merrill Clark - all former 

Board members who are intimately involved in Cornucopia leadership and monitoring 

what is going on here. They are active in their communities. They are working farmers.

Their voices are equally as important as the lobbyists that appear before you. 

The problem is, they can't afford. We can't afford, as Cornucopia, to pay those lobbyists. 

And Goldie, Bill, and Merrill, they can’t afford the... It costs us - and most non-profits

don't have as many people attending - $1500 to $2000 to fly here, to rent a room, to have 

meals, for transportation on the ground. And there are some really important voices in the 

community, not just associated it with Cornucopia, Jay, but not associated with the 

corporate entities that can underwrite their participation. And so I think that is why their

proxies are so fundamentally important. And that is why someone like Liana, who works 

so hard to be up to speed on these things, to be allowed five to 10 minutes to present 

something. In our case, we have about 7500 members - thought to be more organic 

certified farmers than any other policy group in the country. Their voices are funneled 

through Will or Charlotte or myself. Three minutes is a joke. I am sorry. Thank you for 

the question, Jay.

Barry Flamm: Jay, do you have a follow-up question?

Jay Feldman: Yeah, I also... I have many questions. I’m just going to ask this one more. You 

know, I know it is difficult to confront - not for you obviously, but for some people - to 

confront, you know, individuals on issues, especially when they are sitting there, and they 

are representing a sector as we understand it to be in the statute, and then they, of no fault 

of their own, got an appointment outside that sector. So I just want to clarify. I mean, you
Meeting Of The National Organic Standards Board

May 22, 2012

59

are looking at the statute, you are looking at the... You don't have a beef with the statute 

obviously. You believe that those categories are valuable to the process. And so, what are 

you looking for the community to do, or this Board to do, in that respect?

Mark Kastel: Well, the first of all, I want the Board, hopefully, to go on record with the Secretary 

that you want OFPA respected, both the letter and the spirit of the law. So first let me talk 

about the letter of the law. 

No. When it comes to individuals, we don't have a beef with anyone on this Board, 

anyone who has served on this Board. And, an individual who does not qualify as a 

farmer, if they were chosen to represent, to sit in a handler seat, we would certainly have 

no objection to that individual serving. But you are right, Jay. You know, speaking truth 

to power is highly uncomfortable. But that is our job. Because you folks, I don’t think, 

know the scorecard all the time, because... The perception becomes the reality. 

So we talk about the letter of the law, but let me talk about the spirit of the law too. When 

the representative from General Mills was first nominated by the Secretary to serve in a 

consumer slot and was later withdrawn, that was illegal. When she was put in a scientist 

slot, I would testify to you that, although technically she qualify with her PhD, that the 

spirit of Congress was to create a very diverse panel that represented all kinds of 

interests. And the scientist spot wasn’t scientist hyphen corporate agribusiness. It was 

scientist. So I think that if we... I think that we want to as a community, reinforce the 

spirit of what Congress tried to do. 

This is a highly unique Board. There aren’t other Boards at USDA that have statutory 

authority. If it is stacked with corporate voices...And I’ll use one last example. The past 

chairperson was the number one champion and lobbyist for the Martek proposal on this

Board. What slot did she hold? Do you remember? She was the consumer representative. 

Every single public interest group that commented formally, in writing and orally, 100% 

opposed the Martek petition. Was she representing the interests of consumers in the 

United States? I don't think so. Thank you.

Barry Flamm: Thank you, Mark. I believe Jennifer has a question for you.

Jennifer Taylor: [Inaudible]

Mark Kastel: I can't hear you, Jennifer.

Jennifer Taylor: [Inaudible]

Mark Kastel: You’re still ...

Jennifer Taylor: [Laugh] 

Mark Kastel: Okay, now I can hear you.
Meeting Of The National Organic Standards Board

May 22, 2012

60

Jennifer Taylor: OK, I just want to say this is true. And we appreciate your insight and your 

willingness to take on the rally of the organic community. Thank you. Could you please 

address the concern that you had in your document that dealt with the concept of conflict 

of interest within the commenters? Could you please talk about that a little bit more?

Mark Kastel: Sure. First of all, let me just tell you that we are concerned with conflict of interest 

and transparency in all areas, that this very unique community comes together. So that 

means Board members need to declare, as you folks have been discussing. But I think 

appropriately that people in the audience who are aware of conflict should bring that up.

For instance, in the last meeting, General Mills has a contractual relationship with Martek

Biosciences to help them produce the materials that were being petitioned. Their

representative on this Board did not mention that. It was, there was knowledge of that in 

the audience. We don't have the ability to bring that forward. But I think this Board has to 

operate with full knowledge. 

In terms of the Board members, the technical review folks, and people who are standing 

up here, who are representing to you, that they are coming to you and giving you factual 

information. I don't think anyone should be disqualified from standing at this podium 

regardless if they represent corporate interests or public interests, but you should at least 

have that transparency. So I think, at a very minimum, the consultants at the last meeting 

- and this was where this big wake-up call was from us - waltzed up here without saying 

anything but identifying they're name, and saying I'm a consultant to the community. You

need to know who is paying their meal ticket, who flew them here. So that is number one. 

But I think it is just as important to ask them: have you have done any professional work,

either for the petitioner or in this area of science or in this area of commercial interest. So 

as an example, Doctor Alan Greene who worked for years who, while he was testifying 

on Mead Johnson major pharmaceutical manufacturer, on their website still listed him as 

a consultant and reference. The website, one of the medical peer reviewed literature

sites... I’m sorry, they publish peer reviewed literature, but they have a advisory panel. 

Doctor Alan Greene sited on that website in real time as he was speaking to you folks, 

that he was working for Earthbound Farms. There were two representatives from 

Earthbound Farms on this panel. And I respectfully think that people need to be 

transparent about their financial interests. They need to share that with the community 

and that might elicit questions from the Board but at least you can put their testimony into 

context. I hope that answered your question. Thank you.

Jennifer Taylor: Thank you.

Barry Flamm: Thank you, Mark. Is there any other questions? Nick has a question for you, Mark.

Nick Maravell: I'm going to ask about GMO vaccines. I'm sorry but I'm going to be very pointed 

in my focus during these proceedings. You are suggesting that the committee 

recommendation with regard to the use of GMO vaccines in an emergency situation

needs to be tightened up, clarified, etc. Could you give us some specific ideas as to what 
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May 22, 2012

61

your concerns are? And I will just state that the concerns of the committee were parallel 

to yours. And it is in our expanded comments that we did not want to see this emergency 

provision abused. We don't think it would be abused. But I wanted to hear your viewpoint 

on it, given that we saw a declared emergency as something that affected all livestock 

farmers. It has nothing to do with organic or non-organic, and you were required to obey 

the direction of a federal or state official. So could you clarify how you might want to see 

that tightened up? We certainly, on the committee, would not want to see it abused.

Mark Kastel: Nick, I think we had a kind of a divided, rigorous discussion on the Cornucopia 

Board and within our policy advisors also. I can hear Kevin Engelbert’s you know voice 

in my ear here that there are legitimate emergencies. Part of Kevin’s... this is why I kind 

of wish I had a proxy from Kevin here because he could have written this out a little more 

eloquently than I am going to deliver it. But part of his concern was that, if we have to 

wait for a declared emergency, that if there are individual epidemics on a farm, let’s say, 

that something has to be controlled, we are taking that tool away. So I really have 

sympathy. On the other end of the spectrum, we are talking about a whole new area of 

technology. And we are talking about muddying up, our really militant anti-GMO staff in 

giving consumers a pure option in the marketplace. And I do not think that will serve us 

well. 

So I really support Mac’s comments too in that, as we understand it right now, there are 

only two GMO vaccines that are commonly in practice being used for salmonella in dairy 

and in poultry. And I think you heard Mr. Herbert speaking in the poultry arena. The 

dairy, it’s a, it is a very low utilized product, almost nonexistent. I was not even aware of 

it until we started doing research. So by looking at these as individual materials, by the 

Board reviewing them, and then putting in realistic restrictions, if you approve them, I 

think you are preserving the integrity of the process and still making sure the safety and 

well-being of our livestock and the livelihoods of our family-scale livestock producers 

are protected.

Nick Maravell: Thank you. I think some of the sentiment that we are hearing here goes to the use 

of vaccines as they are normally used, which is as a preventative. And I believe what the 

committee’s view was, is as a preventative, that we were open to petitions. There is a 

second use, much less desired, and that is an emergency use. And under those 

circumstances, we felt other things would come into play. So I think we share your 

concerns here and we are quite willing to entertain petitions to look at specific needs.

Mark Kastel: Nick, I want to emphasize one thing if I may. And that is this, you know, if we put 

this into the restricted category, restricted use, and then here is the caveats. This has been 

horribly... and the reason I want you folks, just not on this subject but in general, to 

really view restricted use in a much more judicious manner is that, because of the track 

record of abuse. For 25 years, I was an independent consultant working primarily for 

farmer owned cooperatives in the organic movement and dairy interests. And one of my 

clients was NC+ Organics which, at the time, was the largest independent seed house in 

the United States - the largest. They have since been purchased by Monsanto. And I 

helped them launch their organic seed division. It is now Blue River Hybrids. Maury 
Meeting Of The National Organic Standards Board

May 22, 2012

62

Johnson used to be on our Board of Directors. When I was doing the market research for 

NC+ Organics - it is a cooperative - and I went out in the field and I talked to certified 

organic farmers about what seeds they were choosing, they told me that they had a letter 

from the... They were using treated seed because the untreated variety wasn't available.

And they had a letter from their supplier, and their supplier was NC+ Organic, or oh, I’m 

sorry, NC+. They had all of them available in untreated, and some of them available in 

certified organic, but they had gotten one of the field salesmen to write them a letter 

saying it wasn’t avail... So the potential for abuse is there. So I am just kind of giving 

you that warning. I am shooting the flare up in the air to make sure that, if you do that, it 

is tight enough that it gives farmers the tools but not license to abuse it.

Nick Maravell: Thank you for those comments. That is one of the issues that we constantly 

grapple with when dealing with commercial availability. And so I appreciate those 

comments.

Mark Kastel: Thank you.

Barry Flamm: Thank you, Mark, we appreciate your comments.

Mark Kastel: Thank you, Mr. Chairman.

Barry Flamm: Patty Lovera. And Patty will be our last speaker before we take a lunch break.

Patty Lovera: Hi. My name is Patty Lovera. I work for an organization called Food and Water 

Watch in Washington, DC. And we are a consumer advocacy organization. So I am 

going to try to quickly cover some concerns about aquaculture and then several other 

issues. 

For those of you that have been coming to these meetings for a while, it is not a surprise 

that we do not like the last recommendation NOSB made on aquaculture, specifically,

allowing open net pens and the use of wild fish as feed for organic aquaculture products. 

We are still very concerned that that is what is guiding the regulation making process. 

And we think that that is worth talking about again, worth reconsidering. And I think that 

it is just really important - and Lisa brought this up earlier from the Center for Food 

Safety - to think about starting in a more restricted way. To do it properly and to build up 

organic aquaculture on a really firm foundation that is compatible with other organic 

standards for livestock. We think the way to do that is in the closed, recirculating, inland 

systems, not in the open net pens, not with wild fish as feed at all.

And then as the Board is, you know, taking into consideration this request from the 

Program to look at materials, we think it is kind of hard to evaluate these materials 

without knowing what systems are going to be allowed to be organic. One material in a 

closed system, it is going to behave very, very differently, serve a very different purpose,

than the same material in an open net system in the open ocean. And so we just really 

throw that out there - to think about that. We submitted a much longer comment about 

this to the docket that kind of reiterates points we make in the fall about specific materials 
Meeting Of The National Organic Standards Board

May 22, 2012

63

with some of that thinking about open systems, closed systems, and some things that 

should not be allowed in any aquaculture system for organic if it is being used for a 

crutch for a poorly operating system to deal with the negative effects of too high a density 

or things like that.

So on a few other topics with the time I have left. I think the other major thing for the 

consumers, you know, who support Food and Water Watch is really in the vein of what 

Liana was talking about from the National Organic Coalition. And Food and Water 

Watch is a member of the National Organic Coalition. And what it boils down to is that 

each of these individual decisions you are making, often on materials or vaccines or 

things like this, in the consumer perception we are now at a point where it is kind of like 

the net effect of all these decisions together is really greater than the sum of the parts. 

So we have this continual perception problem we have to answer for consumers and 

explain to consumers who are confused about what is happening to these standards. And 

it may be not just the decision on corn steep liquor or ARA-DHA but the net perception

we really have to deal with as a community. And I just urge you to keep that in mind as 

you think about many of these topics. 

So, super quickly, we support the letter to the Secretary Vilsack on GMOs. It is long 

overdue for this community to talk about the impact biotechnology is having on it. 

We urge the Program and the Board to think about getting biodiversity into the mix the 

way that the Wild Farm Alliance has suggested. 

We believe that carrageenan, it should not be used in organic products. So we do not 

think it should be listed. 

And finally, on inerts, we think that has to be dealt with as soon as possible. It is one of 

these integrity issues for consumers. It is one of the reasons they come to organic and 

they are learning more about how... what the wild west of inerts. How they are not 

regulated. We don't know what they are. And so organic should be a place where they 

can be assured they are not going to have them. So if you separate of those lists to 

finish... Evaluate them individually and finish List 3 as soon as possible, and List 4 as 

soon as possible after that.

Barry Flamm: Thank you, Patty. Any questions for Patty? Calvin.

Calvin Walker: Food and Water Watch is for open and closed systems, or just closed systems? 

Patty Lovera: We are essentially for recirculating, closed systems. We have not seen any open 

net systems that are not damaging the environment. So, yeah, we think we have to start 

and then probably stop with closed recirculating systems.

Calvin Walker: Thanks.
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May 22, 2012

64

Barry Flamm: Colehour has a question for you, Patty.

Colehour Bondera: Yes, Patty, thank you for your testimony and I appreciate your work. I think 

my question is actually very similar to, or a repeat to, the question I heard Calvin ask

when there was testimony about the aquaculture question related to closed systems and it 

is: whether or not you have any examples that you might call upon or references of

experiences - not necessarily Food and Water Watch’s - but that we might look at when

we are considering this aquaculture question. If you have anything to add from a more, I 

don’t know, yeah, reference perspective. Thank you.

Patty Lovera: Sure. So when you're asking questions in the fall, the Materials Committee, about 

how do we start to look at these materials, I think the question on there was: has anyone 

done this well? And our answer in that comment was “no”. We don't think that the EU 

standards, you know, that the new Canadian proposal – we don’t think that they are there 

yet on how to evaluate materials. When it comes to the bigger question of what is a 

responsibly operated, you know, low impact et cetera system for closed recirculating 

systems, there is a new coalition of producers in the US who are interested in this exact 

type of aquaculture. They are moving right along. There is a... So it is called the 

Recirculating Farms Coalition. You know, the woman who is the executive director of 

that has commented in the past. She could not make it to this meeting, but she would be a 

really good resource for the future. Her name is Mary Ann Cufone. I know she would be 

happy to talk to folks. And I actually emailed with her this morning. She is visiting some 

closed recirculating farms in Milwaukee, you know, who are figuring it out on the 

ground. And, if organic can develop a standard that they see working for them, I think 

they would happily embrace it. If it does not and it is very much open net systems and 

going the way of organic salmon, quite frankly, they are just not going to bother with it. 

And they are going to do their own thing because they are figuring it out right now.

Barry Flamm: Jay has a question for you, Patty.

Jay Feldmen: Thanks, Patty, and thanks for the work that you do. You know, this might be a 

really good opportunity for the NOSB to get it right, you know, at the front end. And 

Calvin actually made a suggestion after some of his first year of experiences around a 

process that would enable the Board on questions of materials, which is typically where 

this does not happen, to bring a discussion document on materials to the community 

before we actually are faced with voting. The aquaculture working group has 10 synthetic 

material petitions before the Board right now. And if we proceed as I understand the 

Program would like us to proceed, we will be here at the next meeting in the fall with 

recommendations on those 10 materials. 

We have not yet seen any guidance on the 2008 policy. Some people have told us that 

parts of that policy may be illegal, unlawful. We don't know how the materials fit the into 

the larger policy framework. This might be an example, Calvin, of a situation where you 

would want, the Board would want to get the material discussion out in front of you and 

the community before we actually, you know, vote on allowing materials. 
Meeting Of The National Organic Standards Board

May 22, 2012

65

One of the things we have not had real good access to yet is the kind of independent 

science that you are suggesting be developed, or is being developed. We have heard from 

the aquaculture working group, industry-related people who are, you know, include

scientists to the industry but we have not heard necessarily yet from independent sources 

on that. So it sounds like you are willing to assist and bring the resources that you guys 

have to this process. 

What would you recommend the course of action be in terms of Board action, given that 

we are facing 10 petitions on synthetics in aquaculture perhaps at the next meeting? What 

would you recommend the chair of the Livestock Committee do if indeed that is where 

all this ends up? It has been in Materials Committee up until this point. What would you 

recommend we do in terms of process? Chart out for us where you think we should take 

this process next.

Patty Lovera: That is a good question. It is kind of the ultimate question for this issue, I think,

and it is kind of intertwined with what the NOP is doing. I mean if I was on the Board, I 

think I would be really asking the NOP frequently: what are these regulations going to 

look like? Are we looking at open systems or closed systems? You know, we have an 

opinion is should not be the open net systems. 

If that can’t happen, if you don't get that clarity, I think sadly you have to evaluate these 

materials on two tracks. So I know that in the comment that we submitted, there are just a 

couple of examples. Where, for example, using a vitamin or a nutrient in a closed system, 

you probably use it in a very small amount as a supplement. If you use iron in that way in 

an open system to fertilize growth, you are also fertilizing, you know, growth for free for

everything outside that net too. You know, fish that you are not going to harvest. You are 

changing the environment for them. 

So the same material could be very different in two different settings. So I think it kind of 

doubles the work for the Board. But I think that is what has to be done if you don't know 

what you are looking at for what an organic aquaculture operation is going to be.

Barry Flamm: Follow up, Jay?

Jay Feldman: Here is one more question for you. One of the things the aquaculture working 

group has said to the Materials Committee is, on this question of release, is that any 

release of vitamins, nutrients, would be an adventitious presence, which sort of rang a 

bell in the back of my brain which didn’t sound too good. But their argument is that the 

release would be helpful to the environment and that is something we have not heard the 

other side of the argument on.

Patty Lovera: I think that is overly simplified. To act like adding nutrients of any kind to a 

ecosystem is beneficial all the time. So, you know, in different parts of the world, there

are well documented cases where sharks are drawn to open net pens because there is like 

a salad bar for them. There is food floating out all the time. There is fish escaping all the 

time. Other organisms are coming in to eat the waste. But they are building up an 
Meeting Of The National Organic Standards Board

May 22, 2012

66

unnatural food chain there. And then the sharks get a little greedy, and they start to attack 

cages, and then more fish get out. So I mean this is not a controlled option – an open net 

ocean systems. And to act like it is that simple, like you are just fertilizing the ocean, it is

never that simple in natural systems. So I don’t think that is a good baseline to start from. 

And we are happy to try to find... You know, we have been, I think about a year ago we 

submitted quite long comment with some of the ecological concerns we have. And I'm 

happy to resubmit that and get our folks to update it if there is more stuff.

Barry Flamm: Miles?

Miles McEvoy: Yeah, just an update on aquaculture: The Program has put together a work group 

working on aquaculture to develop a proposed rule to come out hopefully next year. This 

is based on the NOSB recommendations. The NOSB has put in a lot of time and energy 

into developing your recommendations over a period of years. We are in the process of 

implementing those recommendations. Those recommendations, final recommendations 

from this Board included open net pens. So we are not asking the Board to reconsider 

recommendations that you have already finalized. 

What we are asking the Board to do, just like you do with many other systems, is to 

evaluate petitions for these systems. You evaluate materials for aquaculture, for instance, 

and you have added things to the National List even though we don’t have specific 

aquaculture standards. For aquaculture, you have your final recommendations that the 

Board passed. You can utilize those recommendations to move forward with evaluating 

the petitions for aquaculture. 

It is just like how the rule was originally developed. There was no standards when the 

National List was first being proposed by the National Organic Standards Board. You use

your recommendations that you have to evaluate these substances for aquaculture, as we 

move forward to implement organic aquaculture standards based on your work and your

recommendations. So, to reconsider them at this point is really inappropriate.

Barry Flamm: Thank you, Miles. Any other questions? If not, we are going to break for lunch at 

this time and be back here at 1:30 pm. We will continue with the public comments under 

the general category. We have 12 to go yet, so we are running one hour behind schedule 

and I ask the Board just to stay here for a minute. I need to talk to you all before we break 

up for lunch.

[BREAK]

Barry Flamm: We are back in order. We are going to have to change the rules a little bit this 

afternoon for a while. There will only be one question per commenter coming from the 

Board until we get back on track. We could end up being two, three hours behind 

schedule the way things are going. Hate doing it, but that is what we are going to do for a 

while. So, Johanna Mirenda is our first speaker for the afternoon.
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May 22, 2012

67

Johanna Mirenda: My name is Johanna Mirenda. I am materials review specialist for 

Pennsylvania Certified Organic and I would like to comment on recommendations from 

the Livestock Committee and from the Compliance, Accreditation and Certification

Committee. 

Livestock Committee, after a quick rewrite of my comment this morning, I would like to 

thank you for withdrawing the recommendation on vaccines from excluded methods from 

this meeting's agenda. PCO strongly feels that additional research, discussion and 

clarification, is needed on this topic. The recommendation, as is currently written, would 

pose significant challenges to both producers and certifiers. PCO has certified hundreds 

of poultry houses and has reviewed thousands of livestock medical treatment products. 

Many of our certified poultry producers rely on vaccination as part of their preventative 

health care management program. Vaccines for several diseases are currently not 

available in non-GMO form. If organic producers were not able to use vaccination as a 

preventive health care management tool for these diseases it would not only prevent, 

present a significant food safety risk in itself, but it would also conflict with other 

industry regulations that require producers to take preventative measures, including 

vaccination, to ensure food safety. Organic egg producers have told us that they would 

not be able to enter some markets without a vaccination program for salmonella, one of 

the diseases for which a non-GMO form is not available. 

As the Livestock Committee continues to work on this recommendation, we urge you to 

think critically about the areas that the public has identified that require further research 

and clarification. PCO has identified several of these areas in our written public

comment, and we would be happy to participate in future discussions on this topic. 

Compliance, Accreditation, and Certification Committee, we strongly encourage the 

Board to pass the recommendation on criteria for material review organizations. And 

allow NOP to move forward in providing detailed material review criteria to be followed

consistently across all certifiers and material review organizations. Consistent material 

review is critical to providing quality and consistent certification services to all organic 

producers and processors. Thank you, all the committee, for your hard work.

Barry Flamm: Thank you. And, Board, raise your hand if you have a question and Mac Stone 

will decide who will get to ask the question. You got a question?

Mac Stone: I think they were all scared so I will be first. How much variation do you see in the 

vaccine programs based on size or the types of operations you see? How much variation 

in the vaccination schedules do you see?

Johanna Mirenda: I would estimate, at best, that our larger poultry producers are the ones maybe 

using the vaccines but overall, most of our poultry producers are routinely using a 

salmonella and E. coli vaccine.

Barry Flamm: Thank you very much. Steve Mojo. 
Meeting Of The National Organic Standards Board

May 22, 2012

68

Steve Mojo: Mojo

Barry Flamm: Mojo. Thank you, Steve.

Steve Mojo: Thank you. I am Steve Mojo. I am the Executive Director of the Biodegradable 

Products Institute or BPI. The BPI is a not-for-profit trade association started in 1999 and 

represents the major manufacturers of biodegradable mulch films in the United States. 

Our primary goals are, one, to demonstrate and educate consumers and others the role of 

biodegradable products of today's society and, secondly, to promote scientifically-based

standards that ensure these products will fully and safely biodegrade in their intended 

disposal avenues, such as soil, marine, or compost. Today, the BPI consists of 140 

companies located around the world, including suppliers of biodegradable mulch films. 

This is my first visit to the NOSB meeting. Besides introducing the Board to the BPI, I 

hope to observe and better understand your process in preparation for the review of our 

petition - biodegradable mulch films made from bio-plastics. And then, as this petition 

moves forward, to offer any assistance that the Board may need.

Four months ago, the NOP accepted our petition for biodegradable mulch films. And, 

according to the USDA website, the technical evaluation report is being prepared. At a 

future meeting, the BPI will ask that our petition be placed on the National List under the 

crop section 205.601(b): Mulch. 

Our goal is to enable organic growers to use these films if they wish. In fact many 

growers have already encouraged the BPI to submit this petition rather than give up there

organic certification as a few have done. These useful products can improve the 

environmental stewardship of organic production as they provide a more effective tool 

for growers while helping the US organic community reach its stated production and 

growth goals. 

I believe that biodegradable mulch films represent a significant improvement to 

polyethylene plastic mulches and, as such, are compatible with organic farming. In fact, 

other organic standards, such as those in Canada, already allow these biodegradable 

mulch films to be used. Then these Canadian products can be sold in the US and display 

the USDA organic seal. 

Biodegradable mulches provide weed control, moisture retention, and soil warmth and,

unlike polyethylene mulches, they decompose naturally into carbon dioxide and water 

just like the crop residues that are plowed back into the soils at the end of the growing 

season. The performance of these materials has been documented by research at Rodale 

Institute as well as other organic farms. I look forward to working with the NOSB as this 

petition moves forward. Thank you very much.

Barry Flamm: Thank you, Steve. Question? Thank you, Steve.

Steve Mojo: Thank you.
Meeting Of The National Organic Standards Board

May 22, 2012

69

Barry Flamm: David Moore.

David Moore: Good afternoon and thank you for this opportunity to address the Board. My name 

is David Moore. I am a California licensed pest control adviser, qualified applicator, and 

I work for Neudorff. Neudorff is the registrant and manufacture of Sluggo, the ferric 

phosphate snail and slug bait, an NOP compliant pesticide. Sluggo is OMRI and 

ECOCERT listed. It is allowed in organic production in the EU, here in the US and 

elsewhere. 

I would like to thank the Board for their recent unanimous vote to recommend the 

relisting ferric phosphate for another five years and for their careful consideration of a 

petition to remove ferric phosphate from the National List. I also want to thank members 

of the Crops Committee for their diligence and patience as they review the technical 

materials associated with that petition. 

Slugs and snails are a direct challenge to the basic practices of soil fertility management 

and conservation. Fallowing, cover cropping, and minimum till production systems foster 

huge pest mollusk populations that not only damage cover crops but which persist to

damage or, in some cases, destroy subsequent crops. Many agronomically-challenging, 

high-value crops depend on an effective molluskicide to remain economically viable as 

both conventional and organic crops. Economic viability is one of the pillars of sustain... 

one of the three pillars of sustainability, and if organic growers of crops such as leafy 

greens, soft fruits, artichokes, citrus, and ginseng are deprived of Sluggo, these acres will 

likely return to conventional production and these crops will become organic rarities or 

luxuries. 

Remember, the crop pests and diseases are, in themselves, disruptions of the ecological 

balance of the farmer ranch and that growers face three major challenges in correcting 

this imbalance. First, the solution must be effective. But it must also be compliant with all 

laws and regulations, and it cannot compromise food safety. Ferric phosphate is the only 

effective, economically viable organics treatment available for slugs and snails. This is 

clearly established by the market, which has... which as growers have rejected 

alternatives and embraced Sluggo. Indeed the organic community has so far expressed 

only support for this important material. So-called alternatives are not embraced by 

commercial growers. Most are economically impractical. Some are violations of the NOP 

and basic food safety best practices. At least one is a illegal application of an 

unregistered, illegal material. And one or two are pure fantasy. 

Ferric phosphate alone is an effective solution that is consistent with organic agriculture 

and with the Organic Foods Production Act of 1990. Everyone in this room has heard it 

said that organic food, organic agriculture cannot feed the world and we all want to be 

part of refuting that challenge. But if organically produced food becomes, is a luxury, 

offered only to and afforded only by the affluent, then organic agriculture surely will not 

feed the world. This Board’s duty of care is to the organic community and that includes 

dedicated, organic growers that depend on an effective organic molluskicide. But, for 
Meeting Of The National Organic Standards Board

May 22, 2012

70

organic agriculture to feed the world, that duty of care must also be extended to millions 

of people that want to be organic. Thank you.

Barry Flamm: Question?

David Moore: Thank you.

Barry Flamm: Thank you. Cam Wilson?

Cam Wilson: Thank you. I am also here from the company Neudorff. My name is Cam Wilson 

and I am here to talk about ferric phosphate. 

Dear NOSB members, You are probably very familiar with the ferric phosphate issue. It 

has been going on for a couple of years now within the NOSB. A couple of background 

points to talk about first. The active ingredient in the ferric phosphate is on the National 

List for the control of slug and snails in crop production. 

I realize we have submitted a lot of information to you over the last couple of years. I 

have been told voluminous amounts, in the size of a phone book. I would just encourage 

you to take the time to read through the science. The science is there to refute any of the 

allegations that have been made by the company that wants to delist ferric phosphate. 

First and foremost, we support the continued listing of ferric phosphate on the National 

List. Just a bit of background information for you: In 1997, the EPA confirmed that the 

active ingredient in our product Sluggo is ferric phosphate. They registered for the first 

time in ‘97. Our product: the recipe itself has not changed since that original registration. 

In 2005, the NOSB voted “yes” to add ferric phosphate to the National List as a 

molluskicide and, as such, it has become now on the National List as a result.

In 2008, the EPA asked for additional information on our ferric phosphate bait. The

question they put forth to us: is ferric phosphate truly the active ingredient or is it iron 

EDTA? We submitted the science, the same science that has been submitted to the NOSB

and, as a result, the EPA confirmed that the active ingredient was in fact iron phosphate. 

EDTA, which is in the product, is an inert, acts as an inert. And, as a result of that, they 

gave us the NOP language and the OMRI language on that stamped-approved label. In 

other words, they would not be able to do that if they did not believe that we did not show 

without a shadow of a doubt that ferric phosphate was in fact not the, the active 

ingredient. 

A little bit of information about inerts I just want to say for the record: The EPA defines 

an inert as any substance other than an active ingredient, which is intentionally added or 

included in any pesticide product. An example is in a solvent that allows a pesticide’s

active ingredient to penetrate a plant’s outer surface. EDTA is a List 4 inert. List 4 inert 

ingredients are defined as inerts of minimal concern and, specifically, as ingredients for 
Meeting Of The National Organic Standards Board

May 22, 2012

71

which the EPA has sufficient information to reasonably conclude that the current use 

pattern in pesticide products will not adversely affect public health or the environment. 

In 2010, the NOSB voted, as part of the Sunset review process, to relist the existing List 4 

inerts for five more years. As well, in 2010, as part of the Sunset review process, the 

NOSB recommended to relist ferric phosphate as part of the National List. And I am 

being told to stop. Okay. I am obviously a slow talker. I will just conclude then. We have 

had similar allegations like this put forward in Europe. The results were ferric phosphate 

is the active ingredient. EDTA or anything else in the product is an inert, and just... 

Barry Flamm: Cam, will you wrap up? You are over your time limit.

Cam Wilson: We just ask that the NOSB look at this from a point of view of what the other 

countries in the world have done, and the science that the EPA has done, and we just ask 

you to consider the science. And thank you for your time.

Barry Flamm: Board questions? Thank you, Cam. 

Cam Wilson: Thank you.

Barry Flamm: Michael Potter, next.

Michael Potter: Good afternoon, ladies and gentlemen. I am Michael Potter, Chairman and 

President of Eden Foods, in the organic food industry for 43 years. We are not an OTA

member. 

I must object to the greenwashing for more, easy and cheap to produce, quasi-organic 

food. Should organic food be better for large corporations or better for the people? Selfproclaimed organic leaders - self-proclaimed by those in, to those in Washington - long 

ago abandoned quality for quantity - quantity in cash flows, profits and, overall, quantity 

in and of numbers. 

They have adopted the Wall Street ethos that bigger is better and so have completely 

abandoned the organic truth that small is beautiful. Organic food is supposed to be an 

alternative to industrialized food. It is supposed to be the antithesis of commercial food. 

Yet how can it be an alternative to junk food when it is being measured for success with 

the same yardstick used for and by Wall Street rascals? 

The NOSB was designed to be a gatekeeper in order to preserve organic authenticity. To 

do this, they must employ the precautionary principle, always being certain that what 

they do is appropriate for organic food. There is a huge need for something to control the 

inputs into organic food. There is need to offset the efforts of those simply want to make 

as much money as possible doing it the easiest and cheapest way. 
Meeting Of The National Organic Standards Board

May 22, 2012

72

A character of organic agriculture is that it must encourage life in soil. Anything that 

diminishes or limits vitality of soil life ought to be avoided. Anything that stresses or 

destroys soil life must not be used in organic agriculture. 

USDA organic food has a reputation as needing only comply with the paperwork scheme,

a scheme that invites and encourages fraud. It is urgently important than something 

developed to off...something developed to offset this and the role of the NOSB ought to 

be this offset. 

Chemical manufacturers can lay hundreds of pounds of documents before us claiming 

their additive is safe and suitable for organic. Who can counter such a presentation? An 

individual? Objective academia? Is it the people's job to prove them wrong when they 

simply say they are right? They should have to prove beyond a shadow of a doubt, until 

the due diligence of their precautionary principle is entirely met.

Definition of organic food ought to be similar to that of organic agriculture. Anything 

that causes physiological stress in a healthy person eating it should not be added. And the 

handling and processing of organic food should be done to protect and enhance vital 

forces inherent in it. 

Food is a life force and growing and handling and processing it must be looked at in its

entirety not in the myriad of small pieces. First, principles must be set for organic food 

and then the small details looked after accordingly. Looking after small details without 

overriding principles is a recipe for disaster - a disaster where organic food no holds 

credibility with the public. 

At Eden Foods, we hear of trade association’s grandiose numbers touting tens of billions 

of dollars in organic food being sold. This is usually met at Eden with sarcastic comments 

about organic junk food. Organic foods that by no means ought to be called or sold as 

organic food. Thank you for my three minutes.

Barry Flamm: Questions? Thank you, Michael. Whoops, oh, excuse me.

Jay Feldman: Thank you, Michael. Thanks for coming to the NOSB. Welcome. Appreciate you 

being here. I am really interested in getting, since you are such a large producer and have 

a very important presence in the market, the organic marketplace, I am interested in 

getting your specific input on specific materials that we are reviewing. And are you going 

to have, or do you have, specific positions on the materials we will be reviewing over the 

next couple of days? And can we call on you as those come up?

Michael Potter: Eden Foods is a very resourceful company. We welcome being utilized as a 

sounding board. You know, the driving force, I heard someone testify earlier today, that 

you have to hurry up. We need to be bigger. My God, that is not what this is about –

hurry up. We need to do it right. And size is not everything. You know, healthy 

development is what we need. And I am more than willing to participate in any way that 

the Board would deem useful. Thank you.
Meeting Of The National Organic Standards Board

May 22, 2012

73

Barry Flamm: Thank you, Michael. Our next speaker is Alexis Randolph.

Alexis Randolph: Good afternoon. My name is Alexis Randolph, and I represent QAI, an organic 

certification agency. QAI submitted written comments on several different committee 

issues, but I am speaking publicly today to request the NOSB take up the new work plan 

for future meetings. It is very ironic, given Miles’ opening presentation so please 

prioritize this as you see fit. 

We ask that the Board develop criteria for implementation of rule changes. To illustrate 

the necessity for improved guidelines in this area, I will discuss the recent rule change for 

lecithin, and explain challenges certifiers and organic operators are now facing. There is 

exactly 30 days from the Federal Register publication announcing the rule change for 

lecithin to the implementation date in March. Many operators did not prepare to source 

organic lecithin prior to the rule change. 

As you know, the NOSB has made many recommendations to the NOP that have not yet 

been implemented. If companies made changes to their operations based solely on NOSB

recommendations, they could easily be wasting time, money, and in some cases, even

find themselves out of compliance. Preparation goes far beyond identifying a supplier. 

Samples need to be obtained, months of R&D need to be conducted, consumer taste tests 

are performed and then, if all goes well, labels are redesigned. Thirty days was not 

enough time to effectively implement this rule change.

On March 15th, companies stopped organic production. Because 205.606 and commercial 

availability does not apply to products making a “made with organic” claim, some 

companies have continued to use non-organic de-oiled lecithin and reduced products to 

the “made with organic” claim in order to get back into production as fast as possible. 

The “made with organic” claim means that certifiers have to verify agricultural status of 

lecithin, which speaks to another topic at this meeting. We would like the NOP to 

urgently move forward publishing guidance on the classification of materials. I was very 

happy to hear earlier that Miles will be speaking on this topic tomorrow. 

Those companies able to start using organic lecithin are faced with costly label revisions 

just to add an organic designator for the ingredient on their label. QAI expects the 

average manufacturer to take six months in R&D, and one to two years using up labels as 

a result of rule changes. 

Lecithin is just one example. Many National List changes result in organic operators 

performing R&D and making label changes. Additionally, producers and livestock 

operators may find they have spent precious dollars on inputs that they can no longer use. 

We ask the NOSB to consider the impact of rule changes, especially the necessity of 

those changes. And, knowing that some of will be made, we ask for some criteria for 
Meeting Of The National Organic Standards Board

May 22, 2012

74

implementation timelines that the NOP could provide to certifiers in the form of 

guidance.

On a different topic, I would like to briefly mention that QAI submitted written 

comments to the Handling Committee in which we bring up the concern that the NOP

regulations stay in step with international regulations where equivalency agreements have 

now been forged. The NOP regulation, especially the National List, needs to provide a 

level playing field for organic operators to produce the same products in the United States 

as are allowed to be produced in Canada or the EU for import to this country. We ask you 

to consider equivalency agreements as you vote in this meeting and future meetings. 

Thank you for your time.

Barry Flamm: Question? Zea.

Zea Sonnabend: Thank you. This isn't quite so much of a question, or maybe it is a question, but 

as much for Miles as it is for you, Alexis. To me, it would be the NOP’s purview as to a 

grace period for changing labels or a sourcing period when there is a rule change like 

that. But I agree with you. This is something that has worried all of us certifiers for a long 

time - that we are told, time and again, an NOSB recommendation is not law until it 

becomes a law. So you had several years on lecithin to think it was coming, but we have 

been told to not recognize until it becomes a law, and then you only have 30 days. And 

you are absolutely correct. That is not enough time for a reformulation. But I don't think 

it is necessarily the NOSB’s job to determine those details, and more the department. And 

I am wondering if Miles has a response to that.

Miles McEvoy: Yeah, we learned a lot from the rulemaking with lecithin. When it went into 

effect, this is one of the few times that a widely used substance has come off of the list or 

changed its allowance. We had some questions and answers concerning the effectiveness 

of the change. That is on the website. But this is an interesting situation that seems ripe 

for the Board to take a look at. Of when things are coming off the list, things that have 

been in common usage within organic production or handling, what is that transitional 

time period? And how do we work that into the rulemaking process to make that 

transition be as seamless or not disruptive to the industry. So we learned things with this 

lecithin. We will bring back some more information on that to see if we can come up with

better procedures for changes like this in the future. 

Barry Flamm: Thank you. Terry Shistar is our next speaker. 

Terry Shistar: Hi. I have a PowerPoint here. Okay. I am Terry Shistar with Beyond Pesticides. 

We submitted several written comments on a number of issues before the Board. Right 

now I'm going to talk about a few crosscutting issues. 

The NOSB has a duty to review each synthetic material allowed in organic production to 

determine essentiality, environmental and health impacts, and compatibility with organic 

principles. It is a big job and we really do thank you for volunteering to do it. The 
Meeting Of The National Organic Standards Board

May 22, 2012

75

proposed public communications policy would help make the NOSB’s job more efficient 

by encouraging timely input. 

Your action is urgently needed to begin a review process that was called for over a 

decade ago. As a background to the List 3 inerts recommendation indicates, the Board

has been aware of the need to review these ingredients and, in fact, set itself a deadline of 

January 1st 2002, more than 10 years ago, for doing so. It is time to do it now. 

The Board must also adopt a clear and consistent policy on extractants as a first step in 

addressing the other ingredients in processed organic products. The issue of unexamined 

so-called inert ingredients is immensely important to environmentalists and consumers.

One of the first lessons in Pesticides 101 is that inert ingredients are not biologically or 

chemically inert, but are only those ingredients not claimed to have pesticidal action 

against the target pest. You can find the same lesson in publications for hospitals, and 

from the National Pesticide Information Center, or ExToxNet. 

EPA, realizing that the term “inert” is misleading, now calls them “other ingredients”.

The agency no longer supports the system that NOP uses. NOP cannot rely on EPA’s 

evaluation of any material under FIFRA, which has very different standards than OFPA. 

But in the case where the evaluation consists of a list that EPA no longer supports, the 

reliance is completely untenable. 

For the environmental community, the issue of so-called inerts is fundamental. It is about 

exposure to toxic chemicals without informing us. It is about toxic chemicals posing as 

harmless fillers. It is a basic right-to-know issue. We in the environmental community 

believe the organic community should be with us unequivocally on this issue. In the same 

way, other ingredients in processed organic foods are important for the same reasons. 

Thank you.

Barry Flamm: Thank you, Terry. Question? Brise Tencer is our next presenter. Thank you, 

Terry.

Brise Tencer: Thank you. My name is Brise Tencer, and I am the Director of Policy and 

Programs for CCOF Inc., which is the CCOF Trade Association. And I am happy to be 

here just to provide a couple of general comments today. 

First, I would like to start with our kudos to the Board. First, we would like to express our 

very enthusiastic support for the new Committee’s ad hoc Committee on GMOs. We 

think GMOs have presented problems for a long time. And we are really happy to have a 

venue where they can be looked at more thoroughly. We are also supportive of the letter 

to Secretary Vilsack regarding GMOs. 

On another positive note, we want to express our support for the research priorities in that 

framework. Research, of course, is absolutely critical to the organic sector as a whole. 

And we have so many critical issues in front of us that can't be addressed without 

thorough research. 
Meeting Of The National Organic Standards Board

May 22, 2012

76

Looking forward, we do have a couple of thoughts. I want to be on the record of our 

support for organic standards better addressing biodiversity. It is a critical and integral 

part of organic farming systems. We support both guidance and there being a checklist 

for accreditation. 

I want to make a point about unannounced inspections. CCOF continues to try to be a 

leader on unannounced inspections which, we think, is absolutely vital to real 

enforcement and real verification of what is happening. And we strongly encourage 

guidance or rulemaking on this, in the hopes that it can be an integral ongoing part of 

organic certification. 

In general, we think there is a need for continued improvement and clear and consistent 

recommendations on materials that certifiers can understand and enforce. This applies to 

a wide variety of issues from GMO vaccines to the 100% organic label and other topics 

that have been brought up at this meeting. 

On that point of the 100% organic label, I do want to share that we have had 

conversations internally and there is a strong sense that the 100% organic label is 

confusing, it has been difficult to explain, and really difficult to implement consistency. 

Lastly, I want to just mention regarding livestock scorecards that we support strong 

animal welfare that is clear and enforceable. We believe organics should be the gold 

standard in animal welfare, and that there should be no need for any additional animal 

welfare standards. We are prepared to do the work to help get us there, but we need clear 

standards. 

And lastly, please continue to work with the organic community to have a viable public 

input system. It is difficult to do as the industry continues to grow and more people are 

interested in these issues. Three minutes is an awfully short time, but we are all doing our 

best. Thank you so much.

Barry Flamm: Thank you very much for your comment. Question? Thank you. Chris Wilcox is 

the next speaker.

Chris Wilcox: Good afternoon. I am representing Wilcox Farms, a fourth-generation 103 year 

old family business in Washington state. We are a poultry, egg company. I brought some 

pictures. I'm supporting the, and advocating the aviary system. All of our organic 

facilities are in the aviary system. 

Here is a picture of what our farm looks like. You can see the organic growth should 

promote outside access. We should allow for a alternative aviary system. Next, please. 

This is a typical poultry house at our farm. The key factors are training the birds actually 

to go outside. Every day we kind of herd them out and they go out. And then the exits: 

we have 67 linear feet of exits alongside the poultry house and on the back. Next, please.
Meeting Of The National Organic Standards Board

May 22, 2012

77

You can see the inside space calculation needs to allow for square foot created by 

aviaries. Aviaries allow for about an extra 30% square feet. The perches are a natural 

resting space and they should be included. The current wording uses the house’s footprint 

to calculate the inside space. This would make aviaries uneconomical. Next, please.

It is inconsistent: The current recommendations are not consistent with European or 

Canadian organic rules. Our farm builds all of our poultry houses to European standards. 

The maximum flock size: If the committee is worried about big flocks, perhaps you

should have a maximum flock size.

And these are just some suggestions. Don't ban a great alternative production system. 

Thank you.

Barry Flamm: Thank you. Question? Thanks. 

Chris Wilcox: Thank you.

Barry Flamm: Darryl Williams?

Darryl Williams: Good afternoon, Darryl Williams, representing Oregon Tilth Certified Organic.

I am the handling technical specialist. 

Carrageenan is used by a wide variety of certified operations. Amongst other uses for its 

stabilization, emulsification, and protein binding properties, it is notably used by many 

organic soymilk producers because of its vegan and vegetarian sources, and in beer 

manufacturing for its ability to bind with proteins so they can easily be removed. Without 

a proper substitute for all applications in organic production, it should continue to be 

listed on the National List. According to the evaluation criteria identified in 205.600, its

immediate removal without a suitable replacement would be extremely disruptive to 

organic manufacturers. 

Oregon Tilth agrees with the committee's decision to not vote on GMO vaccines proposal 

at this meeting. We feel that there is many refinements needed in order to ensure that the 

policy is sufficiently enforced by certification agents without creating an undue 

paperwork burden on certified organic producers. We are excited to hear your discussion 

this week, and your next action steps for an updated proposal in the future. We did submit 

written comment on this topic, and would welcome any request to discuss this topic with 

you or provide further information.

We do not feel that a non-organic food contact sanitizer should prevent a product or 

ingredient from being labeled as a 100% organic. National List sanitizers are used for 

packaging and for cleaning of equipment without a rinse. If product is run directly after 

sanitation has occurred, there will be a residual sanitizer left on the package or equipment 

unless completely rinsed and tested to show the absence of residual sanitizer. When 

organic production commences, the sanitizer residues left on the package or surface will 

come into contact with organic product. To recommend that a sanitizer used in direct 
Meeting Of The National Organic Standards Board

May 22, 2012

78

food contact will prevent an organic product from being in the 100% category when a 

sanitizer used on a surface which could then be transferred to a product via residual 

contact will not prevent an organic product for being in the 100% category is not 

consistent. 

Not allowing sanitizers to be used on 100% organic products risks bringing more 

negative media attention to the organic movement. We do not believe that this will 

benefit the US organic market. Nor do we believe that allowing the use of sanitizers to be 

used on 100% organic products presents adding any adverse risks to consumers who 

purchase organic products. 

Oregon Tilth’s farm and livestock clients do not utilize the 100% organic category but 

our handlers do. All product are assumed to be 100% organic leaving the farm. Of the 

626 handling clients we currently certify, 159 clients (25%) utilize the 100% organic 

category on their certificates. There are 34% of products certified in the 100% organic 

category. It is worth noting that the vast majority of our clients that utilize the 100% 

organic claim are for the calculation purposes for their buyers who are purchasing 

certified ingredients for further processing and handling.

Barry Flamm: Darryl, would you please wrap up?

Darryl Williams: Yes. Also, the 100% organic content claim is allowed on products. I will just 

end with that.

Barry Flamm: Thank you. Question? Thank you, Darrell. Our next and last public commenter is 

Marty Mesh.

Marty Mesh: Howdy. I thought I was going to be the last one before lunch so I was going to 

make it light, but it is after lunch. I should wake you all up I guess. So my name is Marty 

Mesh. I am executive director of a non-profit called Florida Organic Growers. We 

operate an organic certification program called Quality Certification Services. I have 

been involved in organic farming and the industry since 1972. So I have had the pleasure 

of seeing the frustrations and the growth within it.

So, welcome to the new Board members. Thanks to Miles and his staff for the good work

and the report. Look forward to being able to read the report ‘cause I was sitting way 

back there when y'all post it. 

The GMO letter to Secretary Vilsack, I want to express our thanks and support for it. 

We see Bt resistance no longer as something in the future but something that is here now. 

Bt is a valuable resource and tool for organic farmers and regular farmers and it is on its 

way to being ineffective. We support the concept that the patent holders need to be held 

responsible - and we were glad to see it kind of alluded to in the letter. I think it could be 

made better, even stronger - and that buffers should be really the responsibility of those 

utilizing technology or chemicals, not organic farmers. 
Meeting Of The National Organic Standards Board

May 22, 2012

79

We, I had written the disagreement with Alexis about their GMO vaccine. And then she 

clarified her stance in a letter. And so I will just skip that part, to say we are glad you all 

are tabling it. And that we don't think it is really ready, as it was presented, to go further.

Concerning Miles’ report, we stand ready to help grow organic agriculture in the south. It 

reminds me that, yes, okra still grows well. And we still have never heard from those 

companies who tried to put okra on the non-commercially available list. Even though 

they are not still on the Board, I thought I would just go ahead and mention it. 

Food safety is coming up. And we look to the Board, as well as the Program, to weigh in. 

And organic farmers are hopeful that the Program will weigh in on behalf of organic 

agriculture and ensure that the use of compost and manures that meets the organic 

regulation will not become collateral damage by FDA. 

We did not sign the biodiversity letter due to my travel schedule, but we certainly support 

it. FOG has worked with Joanne for a long time. And we are in fully support of it 

although we remain concerned about what Miles alluded to is the organic certification 

process continuing to be attainable. And so, in that context, we want organic farmers to 

be able to farm, and afford to be able to be certified, and have the time and the capacity to 

do both. And we see the increasing amount of verification required for organic 

certification and paperwork as a weight that organic farmers are starting to just throw off. 

Man, are you kidding me? If you want to ask me about aquaculture, I would say 

something, or calcium sulfate. I don’t know. It is just an idea.

Barry Flamm: Thank you, Marty. Marty, I may be the only one left on the Board that knows your 

okra story. They were sitting in the audience. Question for Marty?

Marty Mesh: There are three.

Mac Stone: Zea.

Zea Sonnabend: Marty, tell us about aquaculture.

Marty Mess: Since we certified, according to the regulation, aquaculture when it was allowed by 

the USDA, and have seen those two aquaculture operations go bankrupt once the ability 

to use the logo was pulled from them and have advocated for standards development for 

years and years, we are happy to see organic aquaculture getting some attention. We 

support the idea of standards. I had a conversation with Lisa and, although she talked

about recirculating things, I think we are in agreement with the fact that recirculating may 

not have been the right term. That they are supportive, as well, of managed pond systems 

and that is what we had certified before in the two domestic shrimp producers that USDA

drove to bankruptcy. So we are glad to see aquaculture standards move forward and

question the idea of materials before the standards as well. 
Meeting Of The National Organic Standards Board

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80

Barry Flamm: Thank you, Marty. 

Marty Mess: And then... was it about calcium sulfate? I don’t know.

Barry Flamm: No. That is the only chance. Thank you, Marty.

Marty Mess: And we will submit written comments in the future given that three minutes goes 

oh so quickly.

Barry Flamm: We are going to move directly into Compliance, Accreditation and Certification.

Joe Dickson, chairperson, I will turn over to you.

Joe Dickson: Thank you, Barry. I believe we have an hour and a half on the schedule here and I 

think we could probably cut that in half and get us back on schedule. We have two very 

straightforward discussion topics today. One is the recommendation of materials review 

organizations, which we will vote on. And the other is the discussion paper on sanitizers 

and the 100% organic category of products. I have asked John Foster first to just give us 

a quick recap of that discussion document. If you are ready to do that?

John Foster: I can get ready. Alright. So this is for those of you have been out in the audience or 

up on the Board actually for the last, any of the last three or four years. This is some... 

This will be a little familiar for some of you. It has had a few different iterations over the 

last few years. That is, I think those are described in the document so I will not belabor 

that. 

But essentially, the question is around the use of sanitizers and the resulting eligibility or 

lack of eligibility for 100% organic claim. The...this kind of presupposes a potential 

distinction between sanitizers and processing aids, which is not necessarily common 

parlance. But in FDA language there is a difference. And how those terms have been 

used in organic production has not been so distinct. So this is an opportunity to dig into 

that a little bit more and provide the community an opportunity to weigh in on that, if 

they choose to. 

The... Kind of in keeping I think, Joe, with not, with trying to get us maybe back on 

schedule, the paper that we, the discussion paper we put out was pretty straightforward. It

speaks also to some of the past discussions that have been had. Some of you in recent 

memory will remember a discussion that ended up focusing on argon and how that is an 

oxygen displacer in some bottling, bottled product manufacturing. That actually started as 

a discussion around this topic and it evolved over the months, actually a little over a year, 

to being something a little different. So this is getting back to a previous version of 

something that we talked about although it does not look like that. I did reference that, we 

did reference that in the discussion document.

Let me scroll to our discussion here. The... let me get back to that. For those of you who 

want to look it up, it was the 2009-2010 NOSB discussions around inert gas packaging 
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81

and the use of the 100% organic claim. A lot of background information is in common if 

you want to look that up. 

There was quite a bit of public comment that came in on this. The... it is variable like 

everything this community tends to speak to. There is a little... there is some people who 

are adamant on one side and those who are adamant on another. So no surprises there but 

we are very appreciative that once again I think CAC has done a good job of using 

discussion documents to flesh out comments ahead of a recommendation if there is one. I 

think this is another good example of using that. 

We had some good discussion amongst the committee. We generated a list of questions 

and many of the commenters dealt with those questions one by one. That was very 

helpful. As were the comments that did not deal with them one by one but took the larger 

approaches to the answer, like questioning the need for the 100% claim. That to me is 

very, that is very helpful. Not... wasn't necessarily the intended outcome, but I think that 

is really important to the discussion and so we recognize that as a potential. We are glad 

to see a lot of commenters speaking to that. This, as this is a discussion document and not 

a recommendation, I can go into a little more detail on public comment if you want, if 

Chair, you would like that. If not...

Joe Dickson: I think we have time for a little more details ...

John Foster: Okay, and then discussion...

Joe Dickson: and summary of the public comments received and then a discussion.

John Foster: Okay. We had a number of certifiers speak to this, a number of whom took the time 

and the effort to survey their client base, which I thought was very helpful, a very 

efficient way to get a lot of people who use these materials to weigh in on it. That was 

very, very helpful. We also got a nice constructive criticism with OTA’s comments that 

made a minor correction on one of the statements we had made relative to current 

guidance and what NOP have to say about it. That was very helpful. Thank you for that. 

Several... one thing that emerged amongst certifiers was that some certifiers do use the 

100% claim on raw agricultural commodities, and some certifiers don't use it at all on 

agricultural commodities and use it only in a processed context. And that is very 

interesting to me that one certifier, who has a lot of processed items and a lot of raw 

agricultural commodities, has just chosen not to get into the 100% claim on anything that 

comes from the field. And for some crops that makes sense, like I can imagine alfalfa 

makes sense. You're not going to have that issue, certainly not with sanitizers coming for 

the alfalfa coming from the field. 

But I can speak with some experience on lettuce coming from a field or broccoli or any 

number of raw agricultural commodities that are field packed. Right now, a great – I 

should not say that – a number of customers and buyers of those products expect good 

agricultural practices to be present in the field. Not only expect it, but demand it as a 
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82

contractual obligation. When you are harvesting those kind of agricultural commodities,

it is expected again and, in some cases, mandated that, for example, the belts on which 

lettuce is dropped to be packed into cartons in the field, which is quite common in 

California, that those belts are sanitized with chlorine or peracetic acid or.., generally it is 

one of those two. Well, right there you have a field packed what we called a raw 

agricultural commodity and, the moment it hits that belt, it contacts some chlorine 

residue. Well, the question is should that or should that not exclude that lettuce, or that

broccoli, or that cauliflower, or whatever, from then being used to..., then being eligible 

for a 100% organic claim. 

That was one of the things that got me interested in this question. Not so much on lettuce, 

but on the results of, say, fruit packing. And very often, in a lot of fruit operations, the 

dump tanks at the packing shed will have chlorine or peracetic acid in it, and all of the 

sudden an apple coming from the field being 100% organic - even if it is not certified to 

that, it is eligible for that. As soon as it goes into a dump tank, it loses that eligibility.

That is very, that is interesting if that pack shed now wants to sell the fruit as an 

ingredient. If the buyer needs to claim a certain percentage in their..., in my finished, say, 

orange juice that I want out of those oranges, I need to know exactly what that... what I 

am able to claim the organic content of those oranges is and it is apparently not 100%. 

There is different scales of that and there is... what I have noticed and what I have talked 

to certifiers and inspectors in the industry, are that there are some certifiers who are not, 

that is not common for them to do and so I think mostly based on inexperience, it is hard 

for processors, handlers to get the kind of numbers, like is it 99% organic? 99.9? 99.99?

That kind of information is hard to get from certifier... from growers typically. 

So that started ask... We started getting a lot more of these questions. That is why the list 

of questions is pretty long. As I said, some certifiers were, if I had to pick one category of 

commenters, it was certifiers, as a... I am very... I am always proud of that one, certifiers 

speak their mind, having been one for a while. And lot of folks were okay with, a lot of 

certifiers were okay with the idea of sanitizers that were on the National List not 

removing the eligibility or cancelling the eligibility for 100% claim. Others were not. 

The public commenters that I could not discern a certification link to or a corporate or a 

company link to, which I think is generally called consumer representation or consumer 

voices, tended not to like that. The most pronounced voices were very clear that, if it is 

100%, it needs to be all 100%, all the time, every bit of. So, and that was very clearly 

stated too. 

I would say, so then, then the last kind of general comment was this question around 

whether or not 100% claims needed to be around at all anyway. And a lot, and there were 

a few folks who went into the origins, and certainly a lot of private standards prior to the 

NOP did not address that at all. And then there are some international issues that are

worth talking about probably in a broader context. But I thought that was an interesting 

outcome also that it is starting to ask the question for whom does this have value? How 

valuable is this claim? And several of the comments spoke to that from their position. 
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83

I think that is a good summary.

Joe Dickson: Thank you, John. Questions or discussion from the Board? Mac?

Mac Stone: There is a little bit about now with the EU equivalency that now that sort of came to 

bear on some of this for processors. Can you explain to me better that current situation?

John Foster: I could go on for a long time. But I think it is better to just note that while our kind 

of production and handling standards are part of that equivalency agreement all labeling 

that is mandated in the EU would still have to be met. So we would have to, our products 

even, though they are manufactured, grown, handled, et cetera, they would still have to 

meet all of the standards that the EU has. Yes.

Mac Stone: I guess I meant relative to the 100% label versus the not 100% label. Wasn’t there 

some question the commenters were referring to that?

Miles McEvoy: Yeah, just a point for clarification: You said “all standards”. You are referring 

to labeling, you have to meet the labeling conditions of the importing country. So, in 

order to ship products to Europe under the equivalency arrangement, you need to meet 

the EU organic labeling requirements and they have to do the same. For them to ship 

products into the US, they have to meet US organic labeling requirements. It is the same 

with our equivalency arrangement with Canada. So it is the labeling standards of the 

importing country needs to be met.

Joe Dickson: Zea

Zea Sonnabend: The main issue I have with this whole discussion is that it fails the common 

sense rule of organic in any way, shape, or form. Which, for example, if I grow apples 

and I wash them in chlorinated water, then they cannot be called 100% organic apples 

because there has been processing aid, sanitizer - whatever you want to call that –

involved. But then, if I sell those apples to an apple juice maker, and say they are 

certified by someone different than I am certified by, they can make those apples into 

juice and call it 100% organic apple juice because they don't have to go back and look 

and see whether I washed my apples in chlorinated water. They just know that it is 100% 

apples, no matter whether I call them 100% or not 100%. You see what I am talking 

about? 

This is one reason why I do not think there should be a 100% label to start with. We 

should just get rid of 100% because it means to most people that the single ingredient is 

100% of what you say it is going to be. And so it means that the apple juice is made of 

100% apples. And they are organic apples, not that a processing aid or a sanitizer may or 

may not have been used. So, you know, our organizational position is get rid of it. It is 

too confusing. It just does not make sense to consumers and any, no matter what policy 

you adopt. But good luck adopting a policy.
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84

Joe Dickson: Zea, I have a question back at you. We heard from a couple of commenters and I 

have heard over the years from different organizations, that the 100% category has the

potential to be a really good resource for consumers who are looking to avoid organic 

products with no synthetic ingredients, with none of the 5%. Do you see that argument as 

having any validity? Or do you think otherwise?

Zea Sonnabend: I do see that as having validity, but then you have to make a clear-cut statement 

that it applies only to ingredients and not sanitizers.

Joe Dickson: Jay, did you have any questions?

Jay Feldman: Yeah. [Inaudible] I sort of agree with Zea on this. I think, if you go back 

historically and look at how we got to this 100%, I think it is fair to say that it was a 

trade-off on allowing 5% - of the 95-5 - to be synthetic, recognizing that the initial law 

was intended to really only allow non-organic non- synthetic in the 5%. And creating the 

100% category enabled the NOSB then to offer, as you are suggesting, to consumers a 

product that did not have synthetics in it. And was really the only opportunity at that 

point to get products without synthetics in it. 

So, you know, I agree if we go down that route we would have to be much more specific

on the labels to how we are defining 100%. Otherwise, the presumption is going to be 

that there are no residues added, purposefully added. And along those lines, it is not clear 

to me - you know this is outside my area really, but - whether product that comes, is used 

and comes into contact or directly with food as opposed to surfaces, then which our food 

is exposed to or raw agricultural commodities are exposed to. Are we making that 

distinction here? For instance, are there sanitizers that are used in a manner that, to which 

food is directly exposed, dunked for instance? And that is still not clear to me whether we

are making that distinction. So if we were to put a label on there that said 100% organic,

which does not include sanitizers, which people can, I think, can understand on some 

level. What do we mean by sanitizers really? Is it just food contact substances? Or is it 

materials to which food are, or can it include materials to which food are directly 

exposed? Not through a surface exposure, but directly. And that you can, maybe you can 

help clarify that for me.

John Foster: I would go with what the FDA definition of sanitizer is when I would define it. I 

don't know that we are going to do it any better than that. They have been at it for quite a 

while. The distinction: I am not quite sure what the distinction you are drawing between 

direct versus contact. I’m not... We can get into that later. But I think it is worth 

clarifying. But the definition, FDA’s definition, is pretty clear, and that is how I, that is 

where I would start anyway. 

But what I was going to say earlier was another interesting comment was pointing out, 

this is an old, I’d say not the first time I have heard but it but it has not got a lot of press 

lately, is that the category heading of 605 is about ingredients. And what is odd about the 

list in 605 is that there are many things that are never going to be ingredients and yet the 

header of 205.605 says ingredients. And I don't know, back in 2001 or somewhere in 
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85

there, at one of the trainings - it might have been in 2000 in Atlanta actually - that I 

remember that question coming up with, I think, Keith Jones. And the list - I don't have 

it in front of me – but the list says something like “ingredients in or on” and the use of the

proposition “on” there then implied that it was anything that might go on to, and 

somehow the word ingredients got, kind of, it got forgotten. 

So one of my questions over the years has always been to what extent should that 605 be 

ingredients versus processing aids and sanitizers and whatnot? Or that’s... I keep looking

over at the Program and, I’m sorry, I don't want to put you in that spot but it... that... A

couple of commenters brought that up again and I think that is going to be part of this

discussion as it keeps rolling is to what extent is that list meant to be ingredients versus

processing aids, versus sanitizers. And that... It has been floating around for at least a 

decade, that I can remember, so might as will put it on the list.

Barry Flamm: Joe, since this is a discussion document, and we do have a voting document, 

perhaps we ought to move on to that.

Joe Dickson: Did the Program have anything to add before we go on to the next item? OK.

Miles McEvoy: I am going to have Emily comment on this please.

Emily Brown-Rosen: Which... Hi, this is Emily Brown-Rosen, NOP staff. Which question do 

you want me to answer first? Could you... The ingredients versus processing aids on 

605? 

Joe Dickson: That is a really important question. This sort of... If you can parse the heading of 

605 which, you know, is substances allowed as ingredients in or on processed products 

and how that sort of bears on this discussion of sanitizers and processing aids.

Emily Brown-Rosen: Well, sort of structurally, the list has always said that in the title of 605

ingredients. The NOSB made a recommendation a long time ago - probably 2002 or 3 -

to change the title to say used in or on, not just say ingredients but substances used in or 

on organic food products or something to that effect. And we have not made that change 

at this point. But that was the understanding as to what 605 means. It is the universe of 

synthetic, non-synthetic substances allowed in organic food.

And there was a legal precedent after the Harvey suit. I think in the Harvey second... 

One of his appeals contended that processing aids were not covered under the court 

ruling. And therefore all processing aids were prohibited. But the court rejected that and 

said that it was really clear from the record in Congress et cetera that intended all 

substances whether they were to be... They did not make a distinction at the time between 

ingredients and processing aids. So they are, in fact have always been, considered 

important.

So I would think, you know, I think we could look at, you know, at some point, and there 

was a proposal a long time ago also to divide up the list differently. That is something we 
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86

could, you know, to have a separate section on sanitizers. That might be very useful thing 

rather than the way they are kind of lumped together with processing aids in future. But 

at this point everything that is basically in direct contact with organic products is 

appearing on the National List. That has been the precedent. OK.

Joe Dickson: Emily, one more quick question and then we can move on. Is the Program’s 

thinking that substances in direct contact with organic food, is there any differentiation 

between materials used on food contact surfaces and materials applied directly to the 

food? Like the difference between a chlorine dip and a, say, cutting board sanitizer?

Emily Brown-Rosen: That is a very good question, Joe. Thank you for that question. Yes, we do. 

And I realize this has been unclear and I realize, after we read your proposal, that even 

certifiers are still unclear about this and I know there has been conflicting information in 

the past. But at this point, our position on sanitizers in direct contact is that, yes, there 

would be two categories. 

The sanitizers that are used in direct contact with food, which are normally called

antimicrobials. They are in dunk tanks. They are on carcass washing. They are in egg 

washing. They are either regulated by FDA or EPA. They have a complicated breakdown 

on who regulates what. But those are classed as secondary direct food additives. They are

regulated generally at 21 CFR 173 or they might have a specific food additive listing in 

the CFR. And we consider them processing aids. And therefore those would be, if they 

are in direct contact, then that would preclude the use of a 100% label.

However, sanitizers used on food surfaces, like belts, bins, dairy pipelines, those are 

considered indirect food additives. And NOP at this point does not consider that would 

affect the 100% label claim. That is an equipment cleaning procedure. And it is not, you 

know, does not rank at the level of being a direct food contact. Usually you have good 

agricultural, you know, you have your required sanitizing practices. We did clarify this in 

the chlorine guidance that we issued earlier last year. So...

Joe Dickson: Great. Thank you, Emily. I could ask a million more questions on this which means 

it will be a really fine conversation between now and Providence.

Emily Brown-Rosen: Yeah, we could work with you on revising this.

Joe Dickson: Yeah, we look forward to working with the Program on this issue as it turns in a 

recommendation for sure.

So, moving on to material review organizations. This is now the third meeting in a row 

where this has been an item on the agenda. Prior to the Seattle meeting, we received a 

request from the Program asking the CACC to do some thinking and recommending on 

how the Program should oversee independent organizations that review materials for 

compliance with the standard. Following that request, we issued a discussion document in 

Seattle in April 2011, which asked a series of very specific questions to the organic 

community about how we should fashion this recommendation, and how the Program
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87

should oversee and evaluate these organizations. Our main concern, of course, being that 

there be some consistency between the materials decisions being made by these 

organizations as there had been a few high-profile situations where there were 

inconsistent decisions made by these organizations and obviously that was a problem. 

So we issued a discussion document in Seattle. In Savannah we issued a recommendation 

which laid out some very broad guidelines for the NOP to use in overseeing these 

organizations, ensuring that their materials review decisions made by these organizations 

were consistent with each other and well communicated to affected stakeholders in the 

organic community. At that meeting we got a few really good comments, specifically 

from OMRI and WSDA and the Accredited Certifiers Association, noting that we had 

answered most of the questions that the USDA had asked us, but we had skipped sort of 

the most important one which was: what are the specific protocols and procedures that 

should be followed within the organizations while they are reviewing specific materials. 

So this sort of phase two of that recommendation is an attempt to answer that question 

posed by the NOP which we did not quite nail the first time. 

The recommendation that we are making today received a pretty decent amount of public 

comment from the organic community. To summarize, the Accredited Certifiers 

Association, as Pat mentioned this morning, thought that the recommendation overall was 

very good but that we were inadvertently requiring ISO 65 accreditation from entities that 

were not publishing lists. And that was an oversight and not the intent of the committee. 

So we have edited the recommendation to reflect that. Michelle, would you scroll down 

to that one modification we made? Or one of two modifications we made? 

Michelle Arsenault: [Inaudible]

Joe Dickson: Yeah. Do you have that version? Or I can just describe them, if not.

Michelle Arsenault: [Inaudible]

Joe Dickson: OK. Well in it’s... I can just keep talking while you find that. The same feedback 

as we received from ACA about that ISO 65 requirement, we received from OMRI, from 

MOSA, from WSDA. PCO expressed their support of the recommendation provided that 

it is only effective if it is swiftly implemented by the National Organic Program. OTA

strongly supported the recommendation and proposed one additional minor change,

which we will also review once we have that version on the screen, and that is just a 

really simple clarifying change to basically empower the Program to begin working on 

the issue immediately and, while they are developing an accreditation scope for materials 

review organizations, allowing them to still immediately began to provide some basic 

guidelines to those organizations. 

Michelle Arsenault: [Inaudible]
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Joe Dickson: Yes, that is the one. Ah, actually I am sorry. There are three modifications. The one 

on the screen now shows that, based on feedback we received from one of the

organizations, to also ask the Program to clarify not only how far back to reach in 

determining the absence of excluded and prohibited methods, but also to very explicitly 

clarify whether or not and exactly to what extent prohibited methods are permitted in the 

production of inputs for organic agriculture in different categories.

Michelle, if you would scroll down under recommendation to the next edit I made there.

This is the OTA’s recommended language change, which basically inserts the language 

“in conjunction with and in parallel to NOP’s work in creating an accreditation scope for

materials review”. NOP should provide detailed guidance and criteria on the material 

review process, etc. Simple but important clarifying change.

And then if you scroll down to the second bullet on the following page? The change that 

we made there is simply to insert the language “who publish materials lists” to clarify 

that materials review organizations who publish materials lists should be required to 

obtain and maintain ISO 65 accreditation. 

And that, those are the only changes that we made. The Board did re-vote on this this 

week and accept this, a modified version of the recommendation. Are there questions or 

general discussion from the Board? Zea?

Zea Sonnabend: CCUF submitted comments on this document concerned about the language 

contains... a bullet point that reads “contain a mechanism to ensure consistency in

decisions across MRO’s” was not sufficiently clear enough and that the language should 

be modified to talk about an appeal process in that the appeal process could be accessible 

to both MROs, ACAs, and manufacturers of the inputs. And I think it was a valid concern 

about the document but you haven’t mentioned it.

Joe Dickson: Yeah, well, CCUF commented in general. And, you know, to paraphrase your 

comments, that, you know, in a lot of different areas this recommendation did not go into 

enough detail so as to be successfully implemented by the Program. And in our 

committee discussions, we felt really strongly that this recommendation should be as 

general and, sort of, abstract as possible and give the Program the latitude it would need 

in order to determine how best to implement it. So, in some of those areas, we felt that, 

you know, we were more comfortable expressing our general intent to the Program

without being overly proscriptive about how the Program should implement our 

guidance. On that particular issue, I don't, you know, I don’t think it is objectionable and 

I would be open to an amendment if other members of the Board are interested and don’t 

see an issue there. 

Are there other questions about this recommendation from the Board? Or the Program?

Or Miles?
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Miles McEvoy: Yeah, we just had a couple of comments that we already shared with the 

committee. In the proposal, it claims that on numerous occasions certifiers are making 

different decisions regarding allowed input materials. We certainly have seen that from 

time to time when we do our audits that... And we would say that occasionally certifiers 

are making different decisions but, for the most part, the decisions on the allowed inputs 

that certifiers are making are very consistent across the board. There are some instances 

where it is not consistent.

Then the other claim in the proposal is that certifiers are continuing to allow substances 

that NOP has specifically disallowed. And, if that is the case, if you have any specific 

information on that, that would be a serious violation of the standards of the accreditation 

agreements that they have. And we would like that information to be submitted to the 

Program, so we can take appropriate enforcement action.

So, in general, it seems to leave a lot of the specifics to the Program, which is fine. We 

know there is more work that needs to be done in this area. We have the situation where 

we have two organizations that are fairly well recognized, OMRI and WSDA, that 

publish lists. And you have the State of California that is in the process of doing organic 

input material review under their state authority. But we had notified California that we 

do not recognize the organic registration, their organic input program, that they are 

creating because they are not ISO Guide 65 accredited, and they have not asked for that 

program to be part of their state organic program purview. So we don't have direct 

oversight over the implementation of that program. So that particular program that is 

going into effect, that is registering products, supposedly in compliance with the NOP

regulations, is outside of the recognition system that we currently have. I just wanted to 

make the Board aware of that situation.

Joe Dickson: Thank you, Miles. I think on your first clarification there, as far as the 

characterization of the occasions in which a material has been allowed by one agent and 

prohibited by another, that could certainly be amended to more accurately reflect the 

reality there, without substantially changing the recommendation and I would support 

that. 

On the second item, I need to look more carefully at the roots of that language. But my 

understanding is that came largely from characterizations that were brought to us by 

different certification organizations during the last cycle. And we, again as a committee,

can look at ways of, you know, massaging that language to make it more accurately 

reflect the reality as well.

Barry Flamm: Joe, are you through with your part of presenting the discussion documents and 

proposal? Next on our schedule is to hear public comments on the CACC proposal. So...

Joe Dickson: Yeah, let’s... 

Barry Flamm: If you are through, I will ask for the public comments.
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90

Joe Dickson: Yes, I am through presenting. I think we should move on to public comments.

Barry Flamm: Thank you. I have on my list, Tawnya Laveta, I hope I’m... Oh, and Peggy Miars. 

Thank you. Peggy Miars is first. That is the reason I have this guy here.

Peggy Miars: [Inaudible] I’ll start over. Good afternoon. I am Peggy Miars, Executive Director 

of OMRI, the Organic Materials Review Institute. And for those unfamiliar with OMRI, 

we are the material review organization, or MRO, that is not a certifier and that publishes 

a public list. 

Thank you to the CAC Subcommittee for your continued discussion and 

recommendations regarding criteria for recognizing MROs and the criteria that MROs

should use in evaluating input materials. We at OMRI agree that there is a clear need for 

more uniform and consistent policies governing material review organizations. We also

agreed that all organic stakeholders would benefit from a clearly defined NOP guidance 

around the qualifications and activities of organizations conducting material reviews. 

It is obvious from questions, answers, and discussions on the accredited certifiers’ 

association listserv that there are varied degrees of material review being conducted by 

ACAs. At last fall’s NOSB meeting, OMRI presented examples of various things that 

different ACAs may look for and not look for when conducting material review because 

of the varying interpretations, policies and procedures. 

As stated in our written comments, and as Joe stated, we do agree that criteria needed for 

how MROs should verify the use of prohibited materials, such as genetic modification, 

and we also believe that clarification is needed for whether such prohibited materials are 

even allowed for use as inputs in organic production. 

The Board should clarify whether requirements for ISO 65 accreditation are sufficient to 

address some of the subcommittee's recommendations or whether you are suggesting that 

the NOP specifically dictate them. For example, the appropriate education, training and 

experience levels for personnel conducting material review. Or, for example, the 

appropriate levels of personnel resources, infrastructure and documentation to engage in 

on-site inspections. And we request clarification regarding what is specifically prescribed 

and what is open to interpretation by MROs.

We have heard some comments that ISO 65 accreditation should not be required for 

ACAs that do not publish a public list, and Joe just showed us that the committee has 

included that in a revised recommendation. I understand the concern about added time 

and expense for those certifiers, and I urge the committee to include in your revised 

recommendation that, for those ACAs that do not publish a public list, during the material 

review portion of their NOP accreditation audit, the NOP should address some of the 

same criteria that are covered under ISO 65 accreditation that will be required of the 

MROs that do publish a public list. In other words, whether you are IOS 65 accredited or 

not, all MROs should be held to the same requirements and should be audited in similar 
Meeting Of The National Organic Standards Board

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91

ways. And you should also consider that ISO 65 audits are required annually whereas the 

NOP accreditation audits of ACAs are conducted every five years. 

And we look forward to NOP guidance on this topic and to more consistency in material 

review for the benefit of the organic industry and organic consumers. Thank you.

Barry Flamm: Thank you, Peggy. Question? Jay?

Jay Feldman: I will defer to somebody else if we are only asking one question. I was curious as 

to whether you have any specific language that could be incorporated into this 

recommendation?

Peggy Miars: Unfortunately, I don't but we could put that together if you would like us to.

Mac Stone: Joe?

Joe Dickson: Thank you. As far as specific language you would propose, would that be 

regarding... just further clarifying the ISO 65 bullet and just clarifying that, for ACAs 

that don’t publish lists, the NOP should still look at similar criteria as part of the 

accreditation audit?

Peggy Miars: Yes. Correct. Yes.

Joe Dickson: OK. Great.

Barry Flamm: Thank you, Peggy. Now, Tawnya Laveta.

Tawnya Laveta: That is pretty good for not being from New Mexico. 

Barry Flamm: I spent enough time here. I should do a lot better.

Tawnya Laveta: Oh, okay. Well, thank you. Thank you, Chair. And good afternoon, Board

members. My name is Tawnya Laveta. I am a consumer and I also work with local farm 

to market programs here in New Mexico. I live in Santa Fe and I am also a member of the 

Cornucopia Institute. I'm here today as a citizen lobbyist. Since public interest charities 

don't have the same resources as corporate agribusinesses to hire lawyers, lobbyists, and 

expert witnesses, I have volunteered my time to be here today.

The proper food safety environment and meticulous sanitation: Those should be the 

hallmarks of all production systems, conventional and organic. However, the rule says 

products labeled as 100% organic, if processed, must be processed using organically 

produced processing aids. And I do like that idea of separating the sanitizers in that other 

5-0-something. 

We are also concerned about problems with mislabeling non-organic products as organic, 

which the Cornucopia Institute has identified on store shelves and bulk bins in stores 
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92

around the country. They have communicated these concerns to the Board, and would 

like to bring this issue to your attention once again. 

When food manufacturers, who were once committed to the organic label, discontinue 

sourcing organic ingredients and they downgrade their products to 70% - “made with 

organic”, or [cough] “made with organic” or conventional - they should ensure that 

retailers are aware of this change and their products are not incorrectly labeled organic by

in-store signage or by advertising. 

This is especially true for the bulk bins. The Cornucopia Institute has sent numerous 

complaints to the NOP, each one identifying about a dozen retailers that continue to 

mislabel Golden Temple bulk bin granola even after being notified about the change. But

many stores had mislabeled Golden Temple bulk granola for months, just unknowingly. 

Golden Temple had neglected to notify the retailers that their granola was no longer 

organic. Customers who bought this bulk item - [cough] – excuse me - purchased a nonorganic product thinking it was organic and that no way... there was no way of 

independently verifying the product’s organic status. And this constitutes consumer fraud 

in my mind. 

To prevent these, this unintentional in-store mislabeling of products that were once 

organic, manufacturers should be required to change their product’s Universal Product 

Code, the UPC, and the accompanying barcode when they downgrade their product from 

organic to “made with organic” or conventional. Whenever a product’s organic status 

changes, the package must be redesigned and reprinted anyway. The organic label and 

USDA seal must be removed or added. 

We urge you to consider recommending a rule change to require the product’s UPC 

barcode on the product package to change when the product’s organic status changes. 

This would alert the retailer that a change has occurred and ensure that they can [cough] 

change their in-store signage and bulk bin labels. 

We hope that the current Board members will concur with this proposed rule change 

which will have a significant impact on protecting organic consumers like myself from 

mislabeled products with virtually no cost or downside to reputable purveyors of certified 

organic products. And I think it will also protect the integrity of the organic label and the 

food manufacturers, farmers, and retailers who are committed to organic foods. Thank 

you.

Barry Flamm: [Inaudible]

Tawnya Laveta: Thank you, Board.

Barry Flamm: Thank you. Joe, I will turn it back to you for the subcommittee consider whether 

you want to make changes and then whether you are ready to present, to make a... have 

some... make a motion and have it seconded and present for Board vote. But remember 

that the motion needs to be in writing, passed to the secretary, and I will look it over.
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93

Joe Dickson: Yeah, I guess I have a procedural question. I would like to propose a couple of 

changes to the recommendation, sort of following the public comment and Miles’

feedback. To do that most appropriately, do we need to ratify that as a committee, as a 

subcommittee before it goes to the full Board? 

Barry Flamm: [Inaudible] You can... 

Joe Dickson: Question?

Barry Flamm: If you can poll the... yes, and this is the first time we are doing it this way so let's 

see if you can try, if you have, try to poll the committee in a brief amount of time and see 

if you can do that. 

Joe Dickson: And should we do that during a break or just right now?

Barry Flamm: Right now.

Joe Dickson: OK, so I will just talk through... and this all...

Zea Sonnabend: Can ask a point of order about this?

Joe Dickson: Yes, please. 

Zea Sonnabend: At some point, is there time for more discussion among the Board, when... 

either now or when they come back with their modifications to further discussion based 

on public comment?

Barry Flamm: When the motion is made and seconded, I will read the motion and then open it 

for discussion.

Joe Dickson: So the compliance, the CAC Subcommittee will discuss a few more potential 

changes, vote as a subcommittee, and then move to vote as a full Board and then there 

will be discussion. Okay? This is a whole new world here. So in addition to the changes I 

presented before, I would like to stick in a few more. First of all, Miles made two really 

good points about some of the language in the challenges section. Michelle, would you 

scroll to that section with the numerals 1, 2, and 3, etc.? Yeah, exactly. Just down to 

bullet number two there/ I would like to change the word “numerous” to “limited” or 

“certain”. Just to... What’s that?

Michelle Arsenault: [Inaudible]

Joe Dickson: You are right. The second sentence: “on numerous occasions” to change that to 

“on limited occasions” to more accurately reflect that the occasions have been few. Any

objections there from the committee? Okay.
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94

Miles McEvoy: We need to provide a point of clarification here. Lisa.

Lisa Brines: Sorry for the interruption. We just had some discussions about process. So it is our 

understanding that the subcommittee would not need to vote separately on these proposed

amendments. So the committee has provided their proposal to the Board for 

consideration. You are welcome to make amendments to that procedurally, but we don't 

think it needs a separate subcommittee vote to move forward.

Joe Dickson: That is great. Thank you. Jay?

Jay Feldman: So who would the proposal be coming from? Would that be the chair or...? It’s a 

question, process question, to you Barry. Because normally what the chair does in a 

situation like this, or his... previously, is bring it back to the committee, the committee 

deliberates, and then brings it back.

Female: [Inaudible]

Miles McEvoy: So you are in full Board session now. You have a proposal that the 

subcommittee has presented. And you haven't had a motion yet, or you are working on a 

motion. So you are, the full Board is making this work happen, not the subcommittee and 

so at a certain point you will finish this and then you will as, someone will make a motion 

to move forward and the Board as a whole will then take it under consideration. So you 

are in full Board session at this point.

Barry Flamm: But the... the agenda calls for the subcommittee to modify its proposal, if needed. 

That is what they are in the process of doing. And then it can go to the full Board. I 

suggested they just poll. They should have an agreement before they bother making a 

motion. That way... I think we should...

Crowd: [Whispering]

Lisa Brines: Okay, let me take another stab at this. So under Roberts’ Rules, generally debate 

would follow a motion. So that, in general NOSB procedure, you generally discuss the 

motion before somebody actually makes, you discuss the proposal before somebody

actually makes a motion. Because this has come out of a committee, you know, generally 

under Roberts’ Rules, it is sort of assumed that that is a motion that has already been 

seconded because it is within a committee. So I think the discussion that you are having 

right now, I would suggest that somebody perhaps make a motion to... for this particular

and then, this particular proposal. And then we can have a secondary motions to make 

whatever amendments that might be needed. It would be a more efficient way to 

progress.

Barry Flamm: We are charting new ground here, for the audience, in terms of this arrangement. 

And I think since we are already past our 3:15 break, I am going to call for a 15 minute 

break. And we will reconvene and continue this committee's action.
Meeting Of The National Organic Standards Board

May 22, 2012

95

[BREAK]

Barry Flamm: Board, please take your seats. I think I am going to have to get a hearing 

examination for these people. Okay. The Board meeting is back in session. Joe, will you 

continue with your committee action?

Joe Dickson: Yeah. Thank you, Barry. So, we are going to continue to just briefly discuss, as the 

Compliance Subcommittee, a few additional edits to the document.

Michelle Arsenault: Do you want the document up?

Joe Dickson: I would love the document up. Thank you. Can we now go down to the challenges 

again? We would like to change the word “numerous”, the second occurrence of the word 

“numerous” in the second sentence of number two, to “limited”. Are there any objections 

from the committee? Thank you. 

On number three, I would like to insert the language at the beginning of the sentence 

“There is no formal mechanism to prevent”. Oh, you lost your... And then, delete from 

“prevent” to “material review organizations” at the... So that it reads “prevent material 

review organizations”. Yes. And then, delete the word “continue” and insert the words 

“from continuing”. And so the sentence should now read: “There is no formal mechanism 

to prevent material review organizations from continuing to list or register these materials 

as approved for use in organic production and handling.” And that I think more 

accurately describes the limitation of the current model without misrepresenting the sort 

of extent of potential issues there. Miles, does that address your concerns with that 

sentence?

Miles McEvoy: Yeah, the first one works. The third point... I am not sure if I understand what is 

being said there. “There is no formal mechanism to prevent material review organizations 

from continuing to list register these materials”?

Joe Dickson: Oh, okay. Let's say “the materials disallowed by the NOP”. You know what I’m

trying to say? I'm changing the sentence so that it does not imply that there is some 

massive crisis out there. 

Miles McEvoy: I don't think that is correct. I think the OMRI, and WSDA, and others have ways 

of disallowing materials that the NOP directs them to.

Joe Dickson: I guess what I’m trying to say there is that the NOP has no way under the current 

model of compelling OMRI.

Miles McEvoy: Oh, okay. 

Joe Dickson: That is what that sentence was trying to do. So let’s just say there is no formal 

mechanism to allow the NOP to compel material review organizations to no longer...
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96

Miles McEvoy: I would suggest that point number three may not be necessary for getting your 

point across. I would just...

Joe Dickson: I would actually agree that we have covered point number three extensively in the 

earlier two versions of this recommendation and it is really kind of... So let’s just delete 

it.

Mile McEvoy: Yeah. When you can’t figure it out, just delete it.

Crowd: [Laughing]

Joe Dickson: Any objections from the committee? Awesome. Cut it.

Let's skip all the way down now to just above the recommendation section. That change 

we have already discussed as a committee. Keep going down. “In conjunction and 

parallel to” has already been voted on and approved by the committee. 

Bullet two. On that... So “who publish materials lists” - that edit has already been voted

ne by the Board. I would like to insert some more language after “transparency” in a new 

sentence. “For ACAs or other entities that do not publish public lists...”

Male: [Inaudible]

Michelle Arsenault: Say it again. Sorry.

Joe Dickson: You, in the word “other” have a “p” instead of an “o”. 

Michelle Arsenault: Oh. I’ll tidy it up.

Joe Dickson: I’m sorry to copy edit before an audience. I know that is awkward. 

“For ACAs or other entities that do not publish public lists” comma “the NOP should still 

include similar criteria as part of the accreditation process.” And that’s...

Michelle Arsenault: Other criteria? Say it again?

Joe Dickson: “accreditation process”. Period. 

Any discussion or questions or objections from the committee on that one? 

That is the final edit that we have as a committee to that document. If there are no 

objections from the committee to those changes, I would hand it back to the general 

Board. And Mr. Chairman, I would like to make a motion that the Board accept this 

recommendation as amended by the committee.

Female: Second it. 
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97

Male: You [Inaudible]

Female: Want me to second that, Mr. Chair?

Barry Flamm: No. We have a motion and a second to accept the document that has been 

presented on the screen. Is there any discussion on this motion?

Colehour Bondera: [Inaudible] Not exactly a discussion but could you scroll back up so I could 

read the change that was made in the second paragraph of the recommendation? Yes, that 

one. Thank you. Because it wasn't up on the screen last time long enough for me to read. 

Thank you.

Barry Flamm: Are you okay with it, Colehour?

Colehour Bondera: [Inaudible] Yeah, so far. If you can just see if other people have comments, I 

just wanted to be able to look at that. Thank you.

Barry Flamm: As there is no further discussion, I call the question. And we will start with voting 

with Jay Feldman.

Jay Feldman: Are you... Point of order. Are you going to ask for conflicts of interest?

Barry Flamm: Oh, golly. Thanks. My partner here, he wrote me a note and I forgot. Are there 

any conflicts of interest? Anybody want to recuse themselves or abstain? Zea?

Zea Sonnabend: I don't know if you consider this a conflict but I do feel the need to disclose that 

I work for an ACA who makes materials review decisions and also a bit for OMRI on a 

stipend basis for conference call, not for material reviewed on the review panel. So you 

tell me if I should not vote or not.

Barry Flamm: I will defer to the Program. Is there any problem with Zea voting on this?

Miles McEvoy: You know, it’s a... For, Zea, if you're working for an organization that is 

affected by this, directly affected by this particular proposal both for your work with 

OMRI and your work with CCOF in terms of reviewing materials – this is... directly 

affects that organization has well. I think it would be best to recuse yourself from this

vote. 

Zea Sonnabend: Okay. Although I do not benefit financially directly, because I am just paid per 

hour, rather than per thing, but I will recuse myself.

Barry Flamm: Your decision stands - that she should recuse herself?

Male: [Inaudible]

Miles McEvoy: Yes.
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98

Barry Flamm: OK. Zea, would you please recuse yourself from voting?

Harold Austin: Point of disclosure. I sit on the Organic Advisory Board for the WSDA. I don't 

stand to any financial benefit but just a point of disclosure at least.

Miles McEvoy: The Program would say you do not need to recuse yourself because of that 

relationship.

Barry Flamm: Anybody else that needs to declare? Jay?

Jay Feldman: Well, I just... Again, point of order. I feel as a Board member I need clarification 

on the standards that are being used here, because many, as we have discussed many 

times, many Board members work for organizations that have an interest in the materials 

and the processes that we discuss and vote on. And I... And yet do not have any personal 

financial gain associated with that decision. So I feel that... I would like to see more 

clarification on how these determinations are being made, so as to not create a precedent

that would preclude other members down the road from voting even though they have a 

perceived vested interest by virtue of being an employee of a company or organization 

that is involved with, may benefit from in somehow – through increased sales or what 

have you – of those materials. So I don't know, Mr. Chairman. I guess that is just a point 

of concern and hopefully the Board can pursue a process that offers more clarity to the 

Board members on how decisions are being reached, with some sort of checklist perhaps.

I don’t know.

Barry Flamm: I agree. Would you like to address the Jay’s comments, Miles?

Miles McEvoy: Yes, this is going to be point of discussion during the Policy Development 

Subcommittee’s time on Thursday, I believe. The conflict of interest: so we will get into

this in some detail at that point. This is an area that we have learned a lot about learning 

more about FACA committees and how conflict of interest and ethics affects this 

Advisory Committee. And so for this particular situation... Well, in general, what we 

want to do is make sure that the decisions around when we would want people to recuse 

themselves because of their interests, is it a conflict of interest, are done consistently and 

fairly. We want to have a diversity of interests being part of the vote, part of the 

discussion. We need those perspectives. In this particular case, Zea is very involved in 

both of those organizations around those particular issues of material review and approval 

of materials and the criteria. And so her intimate involvement in that part of those 

organizations is, I guess, the criteria where it seems best - because of that impact on 

those organizations - that she recuses herself from this particular vote because of her 

involvement in that aspect of those businesses that she works for.

Barry Flamm: [Inaudible]

Jay Feldman: I believe that... I’m sorry.
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May 22, 2012

99

Barry Flamm: Do have another question?

Jay Feldman: I would just like to say that I don't believe that that interpretation is in conformance 

with our PPM and that - our Policy and Procedures Manual - and that our Policy and 

Procedures Manual talks about a personal financial gain - which Zea does not have in this 

case. And therefore this is a new, obviously a new interpretation of conflict of interest 

which, quite frankly, has caught me by surprise. I can't imagine other Board members are 

not being caught, being taken by surprise here. So again, I would just like the record to 

reflect that, and hopefully down the road we can get more clarity on this. Thank you.

Barry Flamm: Thank you for your comments. I think we definitely need more clarity on this.

Any other... Alright. We will proceed with the voting beginning with Jay Feldman.

Jay Feldman: Yes

The Entire NOSB Board: Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. Yes. Yes.

Barry Flamm: And the Chair votes, yes. 

Crowd: [Laughter]

Male: Jennifer.

Barry Flamm: Boy, am I in trouble.

Crowd: [Laughter]

Jennifer Taylor: Yes.

Barry Flamm: I thought I heard you. Sorry. The ... 14 yeses, zero noes, and of, course one,

recusal. So, I believe that completes the CAC report. We can move directly now to the 

GMO ad hoc Committee. [Inaudible]

Zea Sonnabend: Are you turning it over to me, Barry? For the GMO Committee?

Barry Flamm: Yes.

Zea Sonnabend: OK. Thank you. We decided – just slightly different than the agenda – but Miles 

will talk first about what the NOP current GMO policy is. And then, after that, we will 

talk about our committee and where we go from here. So, Miles?

Crowd: [Laughter]

Miles McEvoy: Okay. I'm going to present the NOP policy on GMOs. This is a policy that we 

issued last year that reflects, basically, a reiteration of the letter that was sent to NASDA 

back in 2004. Basically, I'm just going to read through the policy. We thought that this 
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100

would be a good place to start to understand where the Program’s policy is on GMOs as 

this GMO ad hoc Committee gets started - to understand those parameters, and then get 

the feedback from the Board on the policy, and work that needs to happen with GMOs

and organics. 

So, next slide. I wish this was a little larger, but... The Overview: The Organic Food 

Production Act of 1990 does not mention biotechnology, genetic engineering, or

genetically modified organisms. OFPA prohibits synthetics unless they are allowed and 

allows natural substances unless they are prohibited, but it does not make any mention of 

biotechnology or GMOs because they were not really in commerce or being widely used 

at that time. 

The first National Organic Program proposal, which came out in 1997, did not prohibit 

GMOs or GE substances. And, as you all know, there was a huge public outcry because 

of that - against having GMOs being potentially allowed in organic production and 

handling. Unprecedented number of public comments came in, and the proposed rule was 

withdrawn, and USDA went back to the drawing board. So the second National Organic 

Program proposal, proposed rule, which came out in 2000, excluded the use of GMOs in 

organic production and handling. Next slide.

So, the way that the rule looks at that, that they are, GMOs are prohibited as excluded 

methods – and that is under 7CFR 205.105 under the section of allowed and prohibited 

substances, methods, and ingredients in organic production and handling. It specifically 

says, to be sold or labeled as “100% organic”, “organic”, or “made with organic”

specified ingredients or food groups the product must be produced and handled without 

the use of, specifically without the use of – under Sub e – excluded methods except for 

vaccines provided the vaccines are approved in accordance with 205.600(a). And that is a 

discussion for the Livestock Committee, that they are working on, with GMO vaccines.

But excluded methods are the things that are prohibited. That is how GMOs are 

prohibited under the USDA organic regulations. 

So then you have to go to the definitions to look to see how GMOs are defined. It is 

actually, GMOs are not defined but excluded methods are defined. And they are defined 

in three separate sentences. The first sentence says “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.” So a couple of key concepts there: not possible under natural 

conditions or processes, and not compatible with organic production. And that is where 

the Board would most likely come in – defining what is not compatible with organic 

production. 

The second sentence says “such methods include cell fusion, micro-encapsulation, and 

macro-encapsulation, 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.” So, a lot of use of the term recombinant DNA 

technology, moving genes around, and then these other terms – cell fusion, micro-
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May 22, 2012

101

encapsulation, and macro-encapsulation – that are no, there is no further clarification or

definition of those terms anywhere in the USDA organic regulations. And that is causing 

some questions of interpretation that we want the GMO ad hoc Committee to take a look 

at. 

The third sentence says that “such methods do not include the use of traditional breeding, 

conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture.” So again 

those things are not further defined either. And, in some ways, the second sentence 

somewhat conflicts with the third sentence because some things that are used in 

traditional breeding could be considered cell fusion. And so we really need to work on 

this definition. This definition was developed many years ago to really define more 

clearly and specifically some of the provisions of these different terms that are used in 

this definition.

Okay. So then NOP Policy: This goes back to 2004 when the NOP responded to a letter 

from the National Association of State Departments of Agriculture, NASDA, regarding 

the use of GMOs in organic production and handling. So in September of 2010, the NOP 

published the Program Handbook: Guidance and Instructions for Accredited Certifying 

Agents and Certified Operations. And then, in April 2011, we issued Policy Memo 11-13 

to address GMOs in organic production and handling. And this policy really just 

reiterates the policy that was outlined in the 2004 letter to NASDA and clarifies some 

additional questions concerning GMOs in organic production and handling. And that is 

what I will present now.

So, unfortunately, I can't read this and that is going to be a problem because I don’t 

remember this in detail. So...

Crowd: [Whispering]

Miles McEvoy: Okay. You certainly can all read this. It is on the website, but we do think it is 

important to read through this and answer any specific questions that the Board has. So 

the first issue: Is the inadvertent presence of GMOs in organic seeds a violation of the 

NOP regulations? Can organic producers use seeds that contain the inadvertent presence 

of GMOs? The reply is that 7CRF 205.105 of the NOP regulations prohibits the use of 

GMOs as excluded methods in organic production and handling. The use of excluded 

methods, such as planting genetically modified seeds, would require a specific intent and 

would render any product ineligible for organic certification. However, the inadvertent 

presence of GMOs in organic seeds does not constitute a use because there was no intent 

on the part of the certified operation to use excluded methods. The presence of detectable

GMO residues alone in an organic seed does not constitute a violation of the NOP

regulations. It is the same as if you had an organic seed that had pesticide residues in it. 

The presence of pesticide residues in an organic seed does not make the organic seed 

non-organic unless it exceeds 5 percent of the EPA tolerance level, or those pesticides 

were applied in violation of the standards. If the standards were being used, or being 

followed, then the inadvertent presence of GMO residues, or unavoidable residual 

environmental contaminants, do not render the seed non-organic. 
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So, how do organic producers avoid contact with GMOs? The reply is: Organic producers 

utilize a variety of methods to avoid contact or the unintentional presence of GMOs 

including testing seed sources for GMO presence, delayed or early planting to get 

different flowering times for organic and GMO crops, cooperative agreements with 

neighbors to avoid planting GMO crops adjacent to organic crops, cutting or mowing 

alfalfa prior to flowering, posting signs to notify neighboring farms of the location of 

organic fields, and thorough cleaning of farm equipment that has been used in nonorganic crop production. So there many practices that organic farmers utilize to minimize 

and to avoid contact with GMOs. And conventional farmers, in most situations that I 

have been involved with, are very willing to do things to also try to mitigate that

contamination as well. But more work certainly could be done in that area.

What are organic producers required to do in order to avoid the presence of GMOs in 

their products? Reply: In order to become a certified organic operation, a producer must 

submit an organic system plan to an NOP accredited certifying agent for approval. The 

producer’s organic system plan must include a description of management practices and 

physical barriers established to prevent contact of organic crops with prohibited

substances. So that is one part of the organic system plan is to have systems in place to 

avoid contact with prohibited substances. So certifying agents evaluate those preventative 

practices and buffer zones, to determine if the producer has taken reasonable steps to 

avoid contact with GMOs. That is what is required by the regulations. 

Next issue: Could a farm’s organic certification status be threatened if sufficient buffers 

and barriers are not established and inadvertent contact with GMO material occurs? The 

reply is that organic producers that implement preventative practices, preventative 

measures to avoid contact with GMOs will not have their certification threatened from 

inadvertent presence of the products of excluded methods. But crops grown on certified 

organic operations may be sold, labeled, and represented as organic even with the 

inadvertent presence of GMOs provided that all requirements under 7CFR Part 205 have 

been followed. So if a organic farm does not take actions to establish buffers and barriers 

then that could be a violation of the standard. But, as long as they do, and there is that 

inadvertent contact, they can retain their certification and sell the crop as organic. 

Next issue: Is there a working definition of the word “contamination” within the NOP? 

The reply is there is no definition in the NOP regulations for the word "contamination," 

even though it is mentioned frequently in the standards. The use of excluded methods in 

organic production is prohibited, as cited in 7CFR 205.105. And as an aside, we... In the 

US-EU organic equivalency arrangement, there is certain appendixes to that arrangement 

and the third appendix is to establish an organic working group, to share information 

between the EU and the US on organic production, to learn from each other, and 

continually improve our systems, and to do mutual assessments of each other's programs. 

But one of the provisions in there is to share information on ways to avoid contamination 

from genetically modified organisms. And, because of that, that we put the word 

“contamination” in the agreement, we got some pushback from some various parties, the 

biotech industry in particular, that they were concerned that we were using the word
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May 22, 2012

103

“contamination” in a Federal document and that we were changing federal biotech policy 

which we are not. It was just a simple way of sharing information and continuing to share 

information with the EU. But that word “contamination” is a trigger word for many in 

this particular debate because the biotech industry sees the word “contamination”

meaning that the food, the product, would be unfit for human consumption, not in the 

terms of how we look at it in the Organic Program whereas “contamination” means that 

the product does not meet the organic standards and can't be sold as organic. So it is just a 

different meaning of the term in those two different perspectives.

The next issues: What actions are authorized or required when organic crops or products 

are found to contain unintended or inadvertent genetically modified substances? Reply: 

The inadvertent presence of genetically modified material does not affect the status of the 

certified operation and does not result in loss of organic status for the organic product, 

provided it was produced in accordance with all of the organic requirements under 7CFR 

Part 205. So we do not want to punish the certified operation if they are following the 

requirements. Certifying agents are responsible for working with organic producers to

identify the source of the inadvertent GMOs and to implement reasonable steps to avoid 

contact with GMOs in the future. So we don’t want certifiers to ignore this. We don’t 

want the farmers to be penalized. But if GMOs are found, we want the certifiers and the 

farmers to work together to try to further mitigate the presence of inadvertent GMOs in 

the future. That is the whole concept of continual improvement.

The next issue is: Are organic products tested for genetically modified substances? 

Reply: Under 7CFR 205.670(b), certifying agents may test organic products when there 

is reason to believe that excluded methods were used in the production or handling of an

organic agricultural product. So certifiers have the authority to test. Certifying agents 

may also collect and test organic products from organic handlers to ensure that practices 

are in place to prevent commingling or contamination during handling and processing. So 

they can test in those situations as well. 

Next issue: Are organic products free of GMO contaminants? The reply is: Organic 

standards are process based. The NOP regulations prohibit the use of genetically 

modified organisms. They prohibit commingling or contamination during processing and 

handling, and they require preventative practices to avoid contact with GMOs. Organic 

agricultural products should have minimal, if any, GMO contaminants. However, organic 

food products do not have a zero tolerance for the presence of GMO material. 

The next issue is: Has a tolerance level, for example 5%, been established for the

presence of GMOs in organic agricultural products? Reply: The NOP regulations do not 

establish GMO tolerance levels. The NOP regulations establish a tolerance for the 

presence of pesticides that are registered by the U.S. Environmental Protection Agency 

and that is set at 5% of the EPA tolerance level for the specific residue detected. No 

federal agency, including EPA or USDA has established tolerance levels for the 

inadvertent presence of the products of excluded methods, GMOs. 
Meeting Of The National Organic Standards Board

May 22, 2012

104

Next issue: Processed food sold as “organic” must contain at least 95% organic

ingredients. Are GMOs allowed in the remaining 5% of ingredients? Likewise, processed 

food sold as “made with organic”, specified ingredients or food groups, must contain at 

least 70% organic ingredients. Are GMOs allowed in the remaining 30% of ingredients 

for these products? The reply: The use of GMOs is prohibited in all ingredients in 

“organic” and all ingredients in “made with organic” specified ingredients or food 

groups. There is no provision within the NOP regulations that allows the use of excluded

methods in ingredients or processing aids under the “organic” or “made with organic”

specified ingredients or food groups label categories.

Okay, so that concludes the NOP policy on GMOs. I just wanted to briefly touch on the

OIG organic milk audit and the GMOs there, if that is okay, Zea. 

So the organic milk audit, phase one, had some findings around organic feed and forage. 

They were looking to see whether or not there were any issues with organic feed and 

forage that were received by organic dairies. What they found was that there was no 

testing that they found that certifiers were currently doing for GM material. But they also 

did not find any evidence that GM material or GM inadvertent presence was a problem in 

their findings. So their finding was that the lack of GM testing does not provide assurance 

that feed and forage is not contaminated with GM material. So they use the term

“contaminated with GM material”. They, however, did not define what they meant by 

“contaminated with GM material”. So they are finding that this lack of testing was a 

problem and we have come up with a response to their finding. 

Our response is that GM testing is allowed when certifiers have reason to believe that the 

use of excluded methods has occurred. And we expect certifiers to conduct GM testing if

they suspect that an organic dairy has used a GM soybean or a GM alfalfa. We do 

recognize that limited testing is currently being done by certifiers. And that there needs to 

be a distinction in that testing between violations, which would mean that the GMO was

being used, versus the inadvertent presence of GM material in an organic feed or forage. 

And that is where it gets really tricky of: how do you make that distinction? Our plan is to 

analyze GE testing methods, their costs, their reliability, the very sampling methods that 

could be conducted. Where would you sample? Would you sample at the dairy farm? 

Would you sample at the feed supplier? Would you sample at the farm that is growing the 

soy or the alfalfa? Would you sample the seeds? Would that be the best place to sample? 

We will analyze the results and how that might inform whether the presence of GE 

material would indicate either a violation, which would be the use of GMOs, versus 

inadvertent presence. And then we would determine whether guidance is needed. So we 

will be working on this analysis report. We want to work with the NOSB on that. And we 

have to have our report back to the OIG by February of 2013. 

So that is a quick summary of the policy and our response to the OIG audit.

Zea Sonnabend: Thank you, Miles. Now, while Michelle pulls up my slides, I will mention that 

since that definition was crafted by the NOSB with what became “excluded methods”, 

back in the mid-90s – ‘96 or ‘97 it was finalized – the NOSB has done very little work on 
Meeting Of The National Organic Standards Board

May 22, 2012

105

the issue of GMOs. And I can’t even tell you how many times I have personally have 

stood in public comment in the past and urged for certain things to be done about GMOs, 

to very little avail. And I'm sure many of you have also. So at the time that I was 

appointed to the Board, I decided that that should change. And other Board members 

were feeling a similar amount of frustration. And so, Barry and the Executive Committee 

created the NOSB ad hoc GMO, and I guess it should now say Subcommittee, although 

my slide still says “committee”. Michelle, the slides I sent you about the committee, 

could that come up? 

Male: [Whispering]

Zea Sonnabend: What? Oh. OK, in a second I will take questions to Miles, if there is any 

questions to Miles. I am sorry I did not do that. But, well... Since we are on pause here, 

does any Board member have a question for Miles? Nick.

Nick Maravell: Miles, I just want to get a clearer understanding of the current policy. With 

regard to testing for GMO, which I know is a very sticky wicket so to speak. But you said 

one of the control measures or avoidance measures or mitigating measures was for 

organic producers to test their inputs for GMO, particular seed. However, that is not a 

requirement. Is that correct right now? That as part of your organic system plan, you do 

not have to run a test on all of your seed certified organic and other seed purchased.

Miles McEvoy: Yes, that’s correct. What the requirement is, is that you have procedures in place 

to prevent contamination, to avoid contamination from adjoining land use to prevent 

commingling. So those are the specific requirements. You have to prevent contamination 

from GMOs but also from pesticides and other potential contaminants. So you can do that 

through a variety of mechanisms which may include testing. But it is not required that 

that is one of the mechanisms.

Nick Maravell: If an organic producer were to test and find the presence of GMO in their seed 

stock, what then is the producer required or advised to do?

Miles McEvoy: Well, that would be dependent upon their organic system plan and how they 

would be implementing their organic system plan. So if they were doing testing, then 

they would have then procedures in place, what they would do if they found presence of 

GMOs. So the one farm that I know of that does GM testing is that they would, they 

accept organic feed and forage if it is below, if it meets the non-GMO project’s standards,

which is point 9 percent for feed and forage, and I think point 5 percent for seed. So if it 

is below those thresholds that have been established – I don’t think they call them 

thresholds, but – below those levels that the non-GMO project uses, then that organic 

producer would continue to use that. If it was above that, then they would reject that 

product.

Nick Maravell: OK. So then the organic producer establishes their organic system plan and 

establishes their own criteria for evaluating, if they test, whether or not they would use a 

product that had some presence of GMO.
Meeting Of The National Organic Standards Board

May 22, 2012

106

Miles McEvoy: That is correct.

Nick Maravell: OK. Thank you.

Zea Sonnabend: Are there other questions for Miles? Colehour?

Colehour Bondera: Thank you. And, thank you, Miles. I appreciated that presentation. I did write 

down several different questions and I am going to try to just ask one. And I will hold the 

other ones ‘til the future. But I was just curious: you mentioned something that I wrote 

down as “GMO working group” in reference to the EU and USA. And I would like at 

least another sentence on that if that exists and who serves on that and what you said.

Miles McEvoy: No. If I said “GMO working group” that was a bad mistake. It is an, the Organic 

Working Group is the title of the group and it consists of USDA and the US trade 

representative on the US side and the Director Generate for Agriculture under the EU 

Commission. So those are the two, the parties that are involved in the Organic Working 

Group. And they are involved in implementing the US-EU Organic Equivalency 

Arrangement, working out the details of that. A part of that is also, as a partnership 

between the EU and the US, is to share information on organic production. For instance,

they do not allow methionine to be used in organic poultry production. How did they do 

that? So we can learn from them. We don't allow antibiotics in organic livestock 

production. How do we do that? ‘Cause they allow antibiotics in organic livestock 

production under the European standards. So the idea is to share information and learn 

from each other and get that information out to our respective organic communities. One

of the, one little line in that appendix is that we would also share information about 

methods for avoiding a GMO contamination. And that is the little line that caused some

consternation from our friends in the biotech industry.

Zea Sonnabend: Other questions for Miles? Okay. Thank you. Okay. So as I was saying, we, the 

Board set up an ad hoc GMO Subcommittee to take another look at some of the things 

that had been sitting around wanting to be looked at for the last decade or so. And I am 

the chair of it. So, I could have the next slide? 

Before we get into the substance of the committee, because I sat out there in the audience 

for 20 years now and occasionally had a say, but relatively rarely, I thought it would be a 

good time to just have a moment of audience participation. And so what I would like to 

do is, when I count to three, everyone who thinks there should not be GMOs in organic 

agriculture can join me in saying “no GMOs”. Okay. One, two, three. 

Crowd: No GMOs!!!! [Laughter]

Zea Sonnabend: Thank you.

So, the new committee was set up because the organic industry is very concerned about 

keeping GMOs out of the organic food supply. Manufacturers and consumers alike need 
Meeting Of The National Organic Standards Board

May 22, 2012

107

greater visibility from the leaders of the organic movement, the NOSB, on this subject. 

Excluded methods and the accompanying issues of where to draw the line for exclusion,

how to provide leadership in this area, and how to monitor compliance have not been 

examined since the rule came out. 

The GMO Committee, our first job was to write a mission statement and here is the 

mission statement up on the board. The NOSB accepts responsibility for making 

recommendations that pertain to excluded methods to ensure that genetically modified 

organisms are prohibited in organic production and handling and don’t contaminate

agricultural products. The NOSB ad hoc GMO Committee will examination all the areas 

where GMO contamination poses a threat to organics and will provide leadership in

clarifying what excluded methods actually are, and how compliance to the provisions of 

the rule can be monitored. Next slide. 

So we recognize that this is an issue that cuts across all of the committees. And so, as an 

ad hoc group, our work will be to sort of tie together and keep moving forward the work 

of all the different committees. So some examples, and this, you know, my appointment 

is five years and so I’m working, we as a committee are working on a five-year work

plan. Hopefully, it will keep going on beyond then, in case we don't solve all the GMO

issues in the next five years and get rid of them completely. There will be more work to 

do.

So examples of some of the things that we will do include: examining the GMO 

definitions and regulations in other countries and CODEX to see if we can learn anything 

from them and harmonize better with them. To provide oversight on GMO issues as they 

cross the committees. So certain things, like GMO microorganisms will be used in farm 

inputs as well as in processing ingredients. And we may choose policies that, choose to 

look at policies that apply to both crops, livestock and handling. And then to look at the 

language in the rule that Miles has read about excluded methods in relation to other 

concepts that are also in the rule but not so clearly stated how they relate - concepts like 

unavoidable residual contamination, residue testing and preventative measures to keep 

GMOs out. Next slide. 

So the five-year work plan: These are some of the first-year highlights that we hope to 

start working on right away. And we have started on a few of these. We are going to put 

forward, I hope, a seed purity discussion paper. And this is the step that we like to take 

before we proceed to a recommendation, so that we can gather information from the 

organic community about what type of measures might work for this issue, what type of 

data is out there about the purity of seeds, and other issues related to seed, because after 

all it all starts with the seed and, if we can take some measures in assuring seed purity, we 

will have a jump on assuring everything else about GMOs. So we hope to have a 

discussion paper with questions that members of the public can write in on in the fall. 

We also, as Miles mentioned, will be providing some input to the NOP on their response 

to the OIG audit on the role of GE testing in food and forage. We are going to take up 

some plant breeding issues, such as cell fusion, mutagenesis, which have been bandied 
Meeting Of The National Organic Standards Board

May 22, 2012

108

about without having very clear direction or policy on where they are going. And we are 

going, the CACC may take a look at increasing consistency among certifiers and the 

overall committee about the concept of using decision trees and guidelines for 

preventative measures. And there are some examples that we will have to look at.

So, the first step, which Colehour will present in a moment, will be the letter to the 

Secretary from the NOSB stating that we are claiming responsibility for our part of the 

problem and they need to also claim responsibility. I would like to thank everyone for the 

public comment that we did receive and, in particular, to those of you who submitted

some future ideas for our upcoming work plan; such as, Jim Riddell who gave us a very 

nice pamphlet about preventative measures, and OTA who put in a lot of points about 

their GMO policy. And we encourage you in future public comments to keep those 

coming because we have a lot of work ahead of us and a lot to do. 

So, with that I will turn it over to Colehour to talk about our letter to the Secretary.

Colehour Bondera: Very good, thank you. Michelle is going to put up my simple and brief 

presentation on this topic. But, not the letter my PowerPoint slide 13. 

Which is the, like Zea said, thank you, it is our one recommendation that we are putting 

forth, our first one as a committee and we will be carrying on. The first thing – I guess I 

will start talking about it while she is pulling it up, so we can move on – is really the –

yeah, the next slide – is the importance of the letter. And I just, you know, try to reduce 

that down to a few points, essentially coming from the fact that the public, in many ways,

over a lot of time, was requesting that the NOSB make a statement on integrity of 

organics in relation to GMOs. As is referred to in OFPA, in the Organic Food Production 

Act, the duties of the NOSB include advising the Secretary of Agriculture about 

important issues. And, you know, organics has a stronger voice by using communication 

with the Secretary of Agriculture through the NOP to ensure that time sensitive, these 

time sensitive topics are granted the needed attention.

Yeah, you can go to the next slide, which is just a copy of the letter. I'm not going to read 

the letter in its full. I will, I mean, I assume you have read it. I think I... Yeah, I mean I 

will take a moment and read a couple of paragraphs but I think that because it will to 

stand out. But I think it is a pretty straightforward letter. 

Paragraph four says: “The NOSB ad hoc GMO committee will examine all the areas 

where GMO contamination poses a threat to organics and will provide leadership in 

clarifying what excluded methods actually are, and how compliance to the provisions of 

the rule can be monitored. We see the potential of contamination by genetically 

engineered crops as a critical issue of organic agricultural producers and to the consumers 

of their products. There are significant costs to organic producers and handlers associated 

with preventing this contamination and market loss arising from it.”

And I think, you know, it is worth, as a side comment, especially after what Miles did but 

even what Zea did and even what is here in this, that paragraph of mentioning that really 
Meeting Of The National Organic Standards Board

May 22, 2012

109

there is a interesting both use and reference and time point of the phraseology “excluded 

methods” and then we have formed an ad hoc GMO Committee. We have not formed an 

ad hoc Excluded Methods Committee. So I think that there is still some fine-tuning to be 

working on on these topics. And, you know, they are not exactly synonyms I think is 

worthy of note. But this is how we have moved forward for a variety of reasons and I 

think it is a logical place.

In any case, going to move to the next slide because, you know, Zea mentioned the 

general reality of the public comment and it all was a hundred percent supportive. I note 

that of approximately 35 written comments, 11 of those were specifically about the letter 

to Vilsack, and all were supportive entirely. So I don't have to differentiate really. Really 

a wide range of people though and groups were represented from trade associations, 

public-interest groups, individuals, organizations involved with agriculture from farmers 

to farmer advocacy. I just think a lot of players are making their voices heard and I think 

that that is worthwhile. 

I actually – the next slide – I have even noted a few quotes here, not particularly any bias 

but I just chose a few to highlight, you know, that support. “...strong support for the 

NOSB’s proposed letter to the Secretary”. This next one is a more general one about 

GMOs in general, not specifically about the letter but... “We must protect the integrity of 

organic foods. The consequences of the rapid manipulation to, of genetics as opposed to 

selective breeding are not fully understood, and endanger the whole concept of the 

organic food production, as well as the environment.” Another quote was “...fully 

supports the letter drafted...”. And a final one was again general but “keep GMOs out of 

organics”.

And I will just go to my final slide, which is my final words on this. The integrity of 

organic standards needs to be clear about excluded methods which includes GMOs. 

Really a letter, you know, from the perspective of our committee is really raising the 

topic and pointing out the willingness, you know if you read the letter, the willingness to 

engage in dialogue with the Secretary of Agriculture. I view it as a first step towards 

conclusions which we all, both the organic and the non-organic, can comfortably share. 

And one could argue, I realize, that that is maybe a way of saying that we are open to 

discussing coexistence even though, you know, that is not how I phrased it, not how I see 

it. But I think that the point is that let’s be talking about these issues and not just be 

relying on what is put forth. And I'm happy to, you know, if there is any clarification 

questions, respond. That is all I wanted to present.

Zea Sonnabend: Okay. Is there Board discussion before go to public comment? Nick?

Nick Maravell: Yes, this letter is oriented primarily towards crops and contamination in crops. Is

that correct? And the reason I am asking this is because we are facing a GMO issue with 

regard to animal vaccines where there may be instances where we, the NOSB, might 

recommend the introduction of GMO technology into organic production. So what I 

guess I am asking here is we may need to either seek the help or give advice to the 
Meeting Of The National Organic Standards Board

May 22, 2012

110

Secretary on animal issues as well with regard to GMO. Are you seeing that as a 

possibility in the future or is this sort of our one and only shot so to speak?

Zea Sonnabend: Oh, no. Certainly the letter was not just for crops. It was intended to address 

everything. But recognizing that was actually in the rule besides exclusive methods it 

gives us specific exemption to excluded methods for GMO vaccines to be put on the

National List. And so that is in the rule, and so, you know, we follow the rules, so if that 

is the way it goes, then we will go there. 

Nick Maravell: That is not exactly what I was getting at, but we may need either the assistance of 

the Secretary; because the issues that we're dealing with go beyond the Organic Program.

Zea Sonnabend: Yes, we may. And we were trying to position the letter to not be antagonistic to 

the Secretary but to just claim some leadership in it. Other question? Okay, let's have 

public comment.

Jay Feldman: [Whispering]

Zea Sonnabend: What? Oh, Laura is out for this. Okay. Christine Goodman?

Michelle Arsenault: Zea, I think they just went to look for her, because the person prior to her 

canceled and she did not quite know she was going now.

Jay Feldman: [Whispering]

Zea Sonnabend: Alright. We will go to the next person. Isaura Andaluz? Thank you. Go ahead.

Isaura Andaluz: Good afternoon. My name is Isaura Andaluz and I am here on behalf of 

OSGATA, the Organic Seed Growers Trade Association and as a public citizen. 

As OSGATA: We have concerns. The first one being that we only have three minutes to 

express our concerns for the participation is essential to enhancing organic stakeholder’s

involvement. 

Two, all future NOSB appointments should be made respect with to the letter of the law 

and Congressional intent. Farmer Board representatives must, as is written in the law, 

own and operate a certified organic farm. Further, the independence of NOSB members 

must be maintained by full disclosure by farmers, scientists, environmentalists and 

consumers who are simultaneously employees, contractors, or consultants of corporate 

agribusiness. All interests must be transparent and members should recuse themselves on 

issues where there is a potential conflict of interest. 

Three, the NOP final rule 205.204 must have a deadline to require organic seed with no 

exemptions. We also need a threshold of zero GE contamination to maintain our 

foundation seed clean of any GE material. 
Meeting Of The National Organic Standards Board

May 22, 2012

111

Four, GE contamination is a risk to organic integrity. The result is a loss of consumer 

confidence in our products, whether it is through seed contamination, GMO vaccines, 

organic production, handling, or processing, this contamination dilutes organic integrity. 

Coexistence is not possible with biotechnology until flow and/or contamination is 

controlled.

Finally, we are in support of the biodiversity guidance submitted and the checklist.

Now as a citizen independent of OSGATA: the word “GMO” should be changed to 

“genetically engineered”. Everything is genetically modified. What we are dealing here 

with is genetically engineered. It does not occur in nature. 

Secondly, if this Board continues to allow materials, GMO vaccines and other elements 

to be allowed in organic production, then as a consumer I have no need for organic 

certification. For these same reasons, all the young farmers I am working with are all 

dropping their organic certification. 

Organic products are considered to be receiving a price premium. The truth is organic has 

higher cost productions, employs more people, and implements truly sustainable 

stewardship practices. Organic is the fastest growing agricultural sector and the US 

cannot meet its own market demand. USDA must support, at the same level as 

biotechnology, the organic sector in funding, research, and marketing. 

Thank you for your time, and your, all of your work.

Zea Sonnabend: Are there any questions for our commenter? Okay. Thank you very much. 

Okay. Christine Goodman. Is she here yet? Okay. We will go to Angela Anirton? No? 

Okay. I guess that is all the public commenters that I have on the list for this. Correct? 

Okay. 

So, I guess we are ready to proceed with further Board discussion. And to do that, 

perhaps, Colehour, do you want to put the motion on the floor to adopt the letter? And 

then we will have discussion. 

Colehour Bondera: Yeah. I move to adopt the letter as presented. 

Zea Sonnabend: Second. Oh, it doesn’t need a second because it is from the committee. Okay. 

Further Board discussion. Okay, we are... Nick.

Nick Maravell: I am still a little troubled by this letter and might suggest a two word change 

because I think we need to foreshadow the possibility of going up to the Secretary. On, 

when you say, in the, the letter says in the last paragraph, we intend to keep you informed 

of our recommendation on this issue. The preceding paragraph is about genetic drift 

between farms and mitigation. And I guess my concern is that we keep this open enough 

to say we intend to keep you informed on our recommendations on this issue and other 

GMO related issues.
Meeting Of The National Organic Standards Board

May 22, 2012

112

Zea Sonnabend: This and other issues?

Nick Maravell: This and other GMO, or however you would like. I just want to make it clear that 

this goes beyond genetic drift between farms.

Zea Sonnabend: Okay. Does the maker of the motion accept that? 

Colehour Bondera: Yes. 

Zea Sonnabend: Okay. Further discussion? Okay. I guess we vote. But, Barry, do you lead that?

Barry Flamm: Yeah, I will. If you are ready for the vote, we will begin with you, Zea. 

Zea Sonnabend: Okay. I vote yes. Oh, conflict of interest? We won’t have a conflict of interest?

[Laugh]

Crowd: [Laugh]

Barry Flamm: ... conflict of interest.

Zea Sonnabend: I vote yes.

The Entire NOSB Board : Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. Yes. Yes. Yes. Yes.

Barry Flamm: The chair votes yes.

Zea Sonnabend: Okay, that is unanimous. Without further ado, I am going to bring the hardcopy 

letter up to our Chairman to sign, although we will have to make a wording change and 

have him sign it over again but that concludes our presentation.

Crowd: [Applause]

Zea Sonnabend: There are two copies, and I just hand wrote the little change so that means we 

will have to do it again. Sign right there.

Barry Flamm: Okay. I am signing this letter with great pleasure and I thank the Zea and the 

committee for all there their hard work. Believe it or not, we finished the day’s agenda a 

little ahead of schedule. And we recess until tomorrow at 8:00.

[Event concluded] (End)
Meeting Of The National Organic Standards Board

May 23, 2012

1

United States Department of Agriculture

Agriculture Marketing Service (AMS)

National Organic Program (NOP)

Meeting Of The National Organic Standards Board (NOSB)

May 23, 2012

Hotel Albuquerque Old Town

800 Rio Grande Boulevard NW 

Albuquerque, NM 87104

The National Organic Standards Board convened at 8:00 a.m. with Barry Flamm, Chairperson, 

presiding.

Members Present

Barry Flamm, Chairperson

Harold Austin

Carmela Beck

Colehour Bondera

Joe Dickson

Tracy Favre

Jay Feldman

John Foster

Wendy Fulwider

Nick Maravell

Jean Richardson

Zea Sonnabend

Robert “Mac” Stone

Jennifer Taylor

Calvin Reuben Walker 

National Organic Program Staff

Miles McEvoy, Deputy Administrator

Melissa Bailey, Director, Standards Division

Dr. Lisa Brines, National List Manager

Emily Brown-Rosen, Agricultural Marketing Specialist, Standards Division

Michelle Arsenault, NOS Advisory Board Specialist

**Please note that this transcript may contain errors or omissions and does not represent an 

official record of all proceedings that took place on May 23. 
Meeting Of The National Organic Standards Board

May 23, 2012

2

TABLE OF CONTENTS

PAGE

NOP Materials Classification Overview .......................................................................... 3

Materials Committee...................................................................................................... 12

Break.............................................................................................................................. 38

Materials Committee (continued)................................................................................... 38

Crops Committee ........................................................................................................... 40

Public Comment for Livestock Committee ..................................................................... 61

Lunch............................................................................................................................. 65

Crops Committee (continued)........................................................................................ 65

Livestock Committee ...................................................................................................... 73

Break............................................................................................................................ 100

Livestock Committee (continued)................................................................................ 100
Meeting Of The National Organic Standards Board

May 23, 2012

3

Barry Flamm: Members please take their seat. The National Organic Standards Board meeting is 

back in session. First on the agenda this morning is Materials. And to begin the 

conversation on materials, Lisa Brines, National Organic Program Manager will lead off 

with a little explanation of the process. And then, I will turn the rest of the material 

discussion over to the Committee Chair, Jennifer Taylor. Lisa, please?

Lisa Brines: We are just waiting on slides, so it will be just a moment.

Crowd: [Mumbling]

Lisa Brines: Alright, thank you, good morning, everyone. Okay, so the purpose of the overview 

today is to give an update on the Program’s work on the development of draft guidance

related to classification of materials. 

So, as many of you are aware, classification has been an ongoing project within the 

NOSB for a number of years now. And, recently the Program has indicated its intention 

to move forward with draft guidance. So this is to provide an update, sort of, on where we 

are in the process. Here we go. So, I know the text is a little small, so I apologize for that. 

So, as background, the National Organic Standards Board has issued a number of 

recommendations over the years regarding the classification of materials. A most recent 

one was issued in April of 2011, but they date back to August 2005. So, it has been on the 

work plan for the Board for a number of years. Most recently, in a memo to the NOSB

regarding recommendations made at a recent meeting, the Program had indicated its 

intention to move forward with draft guidance based on the last recommendation that had 

passed the Board. So, that was that was the November 2009 NOSB recommendation.

And there were some minor amendments that were made in 2011. So, as many of you 

know, we have not yet published this draft guidance, so the intent today is to provide as 

much detail as we can in terms of the Program’s current thinking on what this draft 

guidance will ultimately look like. We are pretty far along, so I feel reasonably confident 

in sharing all these details, in terms of what the final project will look like. 

Okay, so, why is this classification guidance needed? So we need a framework to be able 

to classify materials for inputs, to ensure consistency on decisions that are made as 

classifying things as synthetic or non-synthetic. For other substances, it is important to be 

able to classify them as either agricultural or non-agricultural. For placement on the 

National List, it is very important to know how the substance is classified, so we can 

ensure that it is in the proper placement. But, it is important to note that the classification 

decision is a separate decision from the Board's motion to list a substance on the National 
Meeting Of The National Organic Standards Board

May 23, 2012

4

List. So, it is related, but it is a separate decision. So, they are both important, but a 

classification decision does not necessarily mean that the substance is compatible with 

organic agricultural, agriculture or handling or not. So, the guidance is also needed to 

implement the outstanding NOSB recommendations on this topic. 

Okay, so, from NOP's perspective, the purpose of the classification guidance will explain 

the NOP’s policy as related to classification of materials, will describe in detail the 

procedures that should be used to classify substances as either synthetic or non-synthetic, 

or as agricultural or non-agricultural. And, the guidance will be published in conjunction 

with another guidance on permitted substances, which is also in development. So, this is 

a project that we have talked about at past meetings, that the Program is intending to 

publish a guidance at least for crop production inputs of a list of allowed substances. So, 

we have the National List which allows, which indicates the synthetic substances that are 

allowed in organic crop production. But at least to date, there has not been a 

comprehensive list in the regulations of allowed non-synthetic inputs for crop production. 

So we hope this permitted substance list in conjunction with the classifa- guidance will 

provide the clarification which is needed for the industry for those consistent decisions.

Okay, so, what will the guidance document actually look like? We anticipate it will be 

published as three separate related documents. So, the first document is the... will 

contain most of the text, which will be the guidance for classification of materials. And 

there will be two related documents, which contain the decision trees. So the first 

decision tree will include the synthetic, non-synthetic decision tree procedures, and the

second decision tree will be for agricultural and non-agricultural substances. So I know 

within the discussions that the Board and others have had on this topic, there has been 

some discussion on whether additional decision trees might be needed in order to give the 

detail list needed for some materials. At this point, we anticipate just the two decision 

trees. There is just currently one definition for synthetic and non-synthetic in the 

regulations, and a definition for agricultural and non-agricultural. So having two different 

decision trees that might have two different outcomes for the same defined terms did not 

seem consistent. So at this point, we anticipate just those two decision trees to be 

available. 

Okay, so, definitions. A number of new definitions have been included in the NOSB

recommendations regarding classifications. At this point, because we are issuing this as a 

guidance document, rather than a change to the regulations, we are not anticipating the 

need to include those new definitions within the actual rule. So, some of the definitions 

will be included within the scope of the guidance to provide clarification where needed or 

guidance to the users of the documents, but we are not actually anticipating making 

changes in the rule to add those new definitions. The one item that I anticipated a 

question on was that there were proposed changes to the definition for non-agricultural 

within the NOSB recommendation. This is a term that is defined in a different way under 

the NOP rule currently. So, in order to move forward the guidance, we do not anticipate 

at this point amending the definition for non-agricultural. We know that there have been 

some inconsistencies identified with some materials using the current definition. But, at 

this point, in order to move the guidance forward and to get it out, we do not anticipate 
Meeting Of The National Organic Standards Board

May 23, 2012

5

making that change to the regulation. We could revisit that in the future, but that is our 

current plan.

Okay, so just a couple notes on some of the definitions. And I realize for the audience 

you may not be able to read these definitions. But, this presentation will be posted on the 

NOP website so you can look at it more detail. So want to, there are a couple of 

definitions that we are proposing slight changes to, mostly for clarification. I do not think 

it changes the original intent of the NOSB’s definitions. So, one of those changes is for 

the definition of chemical change. So I have the existing definition out there, and I will 

just read you the proposed clarification that we anticipate to include. So, we anticipate 

defining chemical change as a process, for example, a chemical reaction, whereby a 

substance is transformed into one or more other distinct substances. So, it is a little bit 

different, but I think it provides additional, provides clarity that will be helpful. 

And the next definition is extract. So, the NOSB definition is on this screen. I will just 

read our proposed clarification. So, we would define extract: “to separate, withdraw, or 

obtain one or more constituents of an organism, substance or mixture by use of solvents, 

and in parentheses, dissolution, acid-base extraction, or mechanical or physical methods.”

So, the one change from the proposed or recommended definition is we are striking the 

word “essential”. So, it can be, you can extract non-essential substances, as well. And, the 

addition of acid-base extraction as a method used to extract substances.

Okay, next would be the definition of substance. And just a note on this one, because this 

term is not defined within the regulations currently, but, it is used extensively, both in 

terms of the National List of allowed and prohibited substances, but also elsewhere 

throughout the rule. So again, we are not anticipating adding this to the regulations, but I 

will just read you our proposed clarification. And I think this will broaden the scope little 

bit to capture some of the materials that are on the National List, but wouldn't necessarily 

fit within the NOSB’s proposed things. So, something like newspaper or compost, which 

are substances. So the proposed clarification would be a substance would be defined as a 

generic type of material, the new text, such as an element, molecular species, or chemical 

compound that possesses a distinct identity, for example, having a separate CAS number, 

CODEX international numbering system number, or FDA or other agency standard of

identity. Just a minor change, but I think it will be more clear for some of those other 

substances. 

Okay, so that is the definitions. Get down, I think I am going to go through type of 

production, just, so bear with me a little bit. This is going to be background information 

as well. But, for crop input specifically, the synthetic/non-synthetic classification, as you 

are aware, is important to determine whether a substance is allowed, whether it is 

prohibited, or whether it needs to be on the National List. So again, for crop inputs, 

natural substances are generally allowed unless specifically prohibited, and then the 

allowed synthetic inputs specifically need to be listed on section 205.601 of the National 

List. 
Meeting Of The National Organic Standards Board

May 23, 2012

6

So, terms of related to classification, the NOP guidance will state that classification

should be made according to the decision tree, NOP 5033-1. That is the synthetic/nonsynthetic decision tree. And again, we are developing draft guidance for permitted crop 

inputs under a separate guidance document number, which will list the allowed nonsynthetic and synthetic inputs, so, a comprehensive list of inputs that are allowed for 

crop, organic crop production. So, we understand that some substances may not fall on 

this list, and may not have been previously looked at by the Board or by a material review 

organization or certifying agent. So, our intent is that, for substances that are not 

classified on the permitted substance list for crop inputs, we will have to establish a 

separate review process for that. So we anticipate when we publish the permitted 

substance list as final, it is possible we may get new requests to add things to that

permitted list as non-synthetic. We do not currently have a process for petitioning the 

Board for that type of synthetic/non-synthetic decision. If there are some sticky issues, 

we may have to address those on a case-by-case basis. But, we will at least be able to 

accept the request for additions and then decide how to move forward from there. 

Okay. So, for substances that would be considered non-synthetic, one of the tools that is 

available is there is other substances listed elsewhere in the National List that have been 

previously classified. So, even though something may be classified one way for handling 

or for livestock, we know that that does not necessarily mean it would be allowed as a 

crop input. However, we can take advantage of that work that the Board has done on 

classification to have consistent decisions across the different types of production system. 

So what will be clarified in the draft guidance is that for substances that are already 

classified as non-synthetic on 205.605(a) of the National List – those are the nonsynthetic handling inputs , it can be assumed that those are non-synthetic for crop inputs. 

So, those again would be allowed unless they are specifically prohibited on the crop 

section of 602 of the National List. And likewise, for things that are already classified as 

synthetic on section 205.605(b) of the National List, again it is assumed that those would 

be also classified as synthetic for crop use. So they would be prohibited as synthetics 

unless they were listed on section 205.601 of the National List. And then finally, for 

substances that are classified as agricultural on 606 of the National List, the presumption

would be that those would be permitted as crop inputs, again, as natural materials, unless 

they were specifically prohibited. 

Okay, so moving on to livestock. So again, similar to crop inputs, classification is needed 

for livestock inputs to determine again whether the substance is allowed or whether it 

needs to be on the National List. For livestock feed ingredients, classification as 

agricultural/non-agricultural is important to determine whether the substance needs to be 

certified organic. And again, 603 would be the allowed synthetic livestock inputs, 604,

the prohibited natural inputs. Again, for livestock, other natural substances are generally 

allowed for use, with the exception of things that are included in livestock feed and are

agricultural, those have to be certified organic.

Okay, so again, the procedure to be used that will be in the guidance is that, for livestock 

inputs, they should be made according to the same decision tree used for crop inputs for 

synthetic/non-synthetic classification decisions. And again, for things that are not 

Comment [JMS1]: 00:15:00
Meeting Of The National Organic Standards Board

May 23, 2012

7

previously classified, they need a separate, may need a separate review process. At this 

point, the draft guidance for permitted substances is only going to cover crop inputs, 

rather than livestock inputs. So, we will not have that additional resource. But, there will 

be some of the same decisions that can be taken advantage of. 

And this, okay, sorry, is very small. But, similar to crop inputs, again, things that have 

already been classified as natural for handling would presumably be natural for livestock 

inputs and allowed unless prohibited. Things that, again, are non-synthetic on the 

permitted substance list, that is the crop inputs list, would be presumed to be also nonsynthetic for livestock inputs and, again, allowed unless prohibited. Again, synthetic 

substances that are classified for handling as synthetic would not be allowed as livestock 

inputs unless they are specifically listed on the livestock section. And finally, things that 

are agricultural on 606, those that are used as livestock feed ingredients, they would need 

to be certified organic. 

Okay, so moving on to handling. So again, handling is a bit more complicated because of 

the additional details that are, the additional breakdown, in terms of how substances are 

classified for handling use. So again, classification is important to determine placement 

of those non-organic substances on the National List. It is also important for products in 

the “made with organic” category, whether a substance is agricultural or non-agricultural, 

will have some effect. So again, I have listed the references there, and will come up in 

discussions later today. So, 605(a) would be the allowed non-synthetic substances, 605(b) 

allowed synthetic, and 606 is the allowed non-organic agricultural ingredients, which 

again are only allowed when the organic version is not commercially available. 

So in terms of the classification decision process, the guidance will indicate that 

classification of materials used in handling should be first made according to the decision 

tree to classify them as agricultural or non-agricultural. If a substance is class-, and again, 

there is the decision tree number. For substances that are classified as non-agricultural, 

those would need to be further classified as synthetic or non-synthetic, and again, using 

that same decision tree used for crop or livestock inputs. 

Okay, so notes on a couple of issues about separation methods, solvents in handling, 

which will be a topic discussed later today within the Materials Committee, eligibility for 

organic certification, and timeline and next steps.

The separation methods: So, within the guidance, we know that there is, there has been

some concern in terms of what separation techniques would be allowed or change the 

classification decisions. So, we recognize that for some substances, they might be 

isolated from mixtures using a variety of different separation techniques. So, those could 

include things like distillation, also solvent extraction or acid-base extraction, physical or 

mechanical methods like filtration, crushing, centrifugation, gravity separation, there is 

all sorts of methods. The isolated substance could fall under a number of different 

classifications. So depending on the process used and the starting material, that could be 

certified organic, could be non-synthetic, synthetic, agricultural or non-agricultural. So I 

will get into a little bit more detail on what we anticipate putting in the guidance.
Meeting Of The National Organic Standards Board

May 23, 2012

8

So this is just for a comparison. It is not really within the scope of the guidance. But, just 

to compare classification work from the... is different than the process used for certified 

organic substances. So, for certified organic substances, materials used as ingredients, 

extractants, or other processing aids must be organic or must comply with the National 

List. So for example, you can have a certified organic substance that might have been 

extracted with organic ethanol, it might have been extracted with sodium hydroxide 

which is an allowed synthetic, citric acid, carbon dioxide, anything that is, anything that

had been reviewed by the Board and is on the National List, or any organic ingredients or 

processing aides. So, we had clarified this at the last meeting, but, just so as a reminder:

under 205.270, the use of volatile synthetic solvents or other synthetic processing aids are 

prohibited for certified organic substances, unless that solvent or processing aid is on 

205.605. 

So what does this mean for solvents used in handling is that no synthetic solvents or other 

synthetic processing aids in or on organic products, or in or on organic ingredients, can 

be as used unless they are listed on 605. Solvents can be considered a part of the 

manufacturing process for non-organic substances for those listed on 605 that may have, 

that have been reviewed by the NOSB and not further restricted. So examples would be 

lecithin, in the past, pectin or shellac. Non-organic agricultural ingredients in the “made 

with” products may have also been produced with the synthetic processing aids or 

solvents. And non-organic ingredients listed on 606 for use in organic products may have 

also been produced using synthetic solvents or processing aids, unless specifically 

annotated otherwise. 

So again, here is the regulation 205.270. The bold is just for emphasis. So the handler of 

an organic handling operation must not use in or on agricultural products considered to be 

sold, labeled or represented as “100% organic”, “organic”, or “made with organic 

specific ingredients or food groups”, or in or on any ingredients labeled as organic. And 

there is the citation for the prohibition on volatile synthetic solvents for those particular 

types of products.

Okay. And so in terms of classification of materials, the use of solvents for non-organic 

substances: So talk a lot about solvents used for extraction, but it is helpful to recognize 

that solvents are used in many different ways during manufacturing process. So they may

be used as reaction media. It can be used as an extractant, but they can also be used for 

purification or crystallization, for concentration, standardization, serve a number of 

different roles. Seem to focus on the extraction a lot, but there are other uses for solvents

in production of materials. So, the NOSB in reviewing petition materials may always 

consider the use of any substances used in the manufacture of particular materials, 

including solvents, as part of its review of petition materials. So again, the guidance does 

not change any of this, it just clarifies what particular things would be allowed. So, again 

volatile synthetic solvents are prohibited for handling organic products under 205.270, 

unless those specific processing aids would be listed on 605. And according to the draft 

guidance, the use of the synthetic solvent in the process would not necessarily result in a 

substance being classified as synthetic. So, it does not automatically change the 
Meeting Of The National Organic Standards Board

May 23, 2012

9

classification, you have to look at more detail to determine whether the substance 

classification should change.

So, what are the criteria? We have a number of steps that I will go through, in terms of 

what things that would be considered in terms of whether the separation technique 

involved would result in the substance being classified as natural or non-synthetic. It 

would need to meet all of these criteria in order to be considered natural. So, the first 

criteria would be at the end of the extraction process, the substance has not been 

transformed into a different substance via chemical change. So again, chemical change 

will be defined in the guidance using the NOSB recommendation. So, as an example, 

something like citric acid, which is listed as non-synthetic on 605(a), so that is a 

substance produced by microbial fermentation of a carbohydrate substance, then is 

isolated and purified through various techniques, but, again, at the end of the process, and

isolation process, it is not transform into a different substance, so it is classified still as 

non-synthetic on 605(a). 

Okay, so the second criteria would be that the substance has not been isolated in a form 

that does not occur in nature. So again, using citric acid as the example, it is natural when 

produced by microbial fermentation, but something like potassium citrate, which is 

potassium salt of citric acid, would be classified as synthetic on 205.605(b). So that is 

consistent with the Board’s recommendation and the current placement on the National 

List. 

The third criteria would be that any synthetic materials used to separate, isolated or 

extract the substance have been removed from the final substance, for example, through 

evaporation, distillation, precipitation, or other means, such that they have no technical or 

functional effect in the final product. So the example here would be pyrethrins, and many 

botanical pesticides are extracted from the natural materials. So, in the case of pyrethrins, 

they are extracted from the flowers with a synthetic solvent, but the solvent is removed 

prior to product formulation. It does not serve any technical or functional effect in the 

final product. It is just used to extract the pyrethrins from the natural material. So that 

was, again, consistent with how that material has been previously classified. It would still 

be considered non-synthetic. 

The fourth criteria for substances used in crop or livestock production: The substances 

used for formulation would need to be non-synthetic or included in the appropriate 

section of the National List. So, for the example here, again, natural botanical pesticides: 

Even though the active ingredient would be natural, any inerts used for product 

formulation, they would either need to be natural or comply with the National List. The 

current placement for those inerts would be at 205.601(m). 

For handling substances, for those non-organic substances used in handling, those 

substances used in the formulation would need to be provided for in NOSB review of the 

substance or included in the substances annotation on the National List. And we 

understand that the NOSB has on their work plan a recommendation, or is planning a 

recommendation, to clarify other ingredients allowed in handling inputs. So we 
Meeting Of The National Organic Standards Board

May 23, 2012

10

understand that this particular provision might change as a result of that work. But, this is 

our current understanding of practice.

Okay, so, one item that has come up, particularly with respect to the Boards’ 

deliberations on what an appropriate definition of chemical change would be, is that there 

was a concern about crafting a definition that would not result in processed agricultural 

products being classified as synthetic, and potentially ineligible for organic certification. 

So what we anticipate putting in the guidance is the guidance is really just for 

classification. It is not really to be used for determining the eligibility of a substance for 

organic certification. So, assuming a substance contains or is made up of agricultural

ingredients and can meet the NOP requirements for production, handling, processing and 

labeling, it would still be eligible to be certified under the NOP regulations. So the 

classification guidance is just for classification, it is not as a substitute to determine the 

eligibility of any particular material for organic certification. 

Okay, so, a few details on the decision tree: I do not have this in decision tree format, but 

these are the questions that we anticipate putting in the tree. And they should be familiar

because they are fairly consistent with the last recommendation that came out of the 

Board. So the first question would be, is the substance manufactured, produced or 

extracted from a natural source? Does the substance undergo a chemical change? And 

that will be a defined term. Is the substance created by a naturally occurring biological 

process, such as composting, fermentation, or enzymatic digestion, or by heating or 

burning biological manner, matter? And the last piece of that - heating or burning 

biological matter - is a new addition from the, a new addition that the NOP is proposing 

to include in the draft guidance. And that would be consistent with materials, such as ash,

which are classified as non-synthetic on 602. 

Okay, next question on the decision tree would be is the substance created by a naturally 

-- oh, I am sorry, that was a repeat of the second one. Sorry. Is the substance combined 

with other materials to produce a commercial product? And, are those components 

present in the generic substance non-synthetic? So again, some of this is targeted to 

organizations that would be reviewing those inputs for compliance with a producer’s 

organic system plan, but they might also come up during Board deliberation as well. 

Okay, so in addition to having a table with those decision points, we also anticipate 

including a table of example classification decisions with explanations. So, this will give 

some guidance to users of the document on how the decision process should work, with 

specific examples of where the NOP chose, the NOP sees where the line would be, in 

terms of making a particular decision. So I know that for the audience, you cannot read 

all these examples, but again, they will be on this slide, and so it will be listed as 

substance, what the classification decision would be according to the decision tree, and

then just a brief explanation of where on the decision tree that substance, how that 

decision was made, what the final step was.

For the agricultural/non-agricultural decision tree, it will have its own set of questions. 

So, starting with, is the substance derived from a plant, animal, microorganism or 

Comment [JMS2]: 00:30:00
Meeting Of The National Organic Standards Board

May 23, 2012

11

mineral? Is the substance a microorganism, for example, yeast, bacteria, or fungi, or an 

enzyme? Or, is the substance isolated from the product of a microorganism or an 

enzyme? Following that, has the substance been processed to the extent that its chemical 

structure has been changed? 

If there has been a change, is the chemical change a result of naturally occurring 

biological processes such as fermentation, use of enzymes, or a result of mechanical or 

physical processes? And again, have any other, for reviewing of formulated products, 

have any other ingredients been added to the substance that remain in the final product, 

and are those ingredients consistent with the National List for handling? And again, as a 

result of the Board’s work on this issue, that might evolve a little bit. 

So again, similar to the classification decision tree for synthetic/non-synthetic, we will 

include a table with example substances, those classification decisions, and an 

explanation of how we got there using the tree. 

Okay, so that is the overview of the document. In terms of next steps, we hope to put the

draft guidance into clearance this summer. Again, it will be hopefully published in 

conjunction with the draft guidance for permitted substances for organic crop production. 

That way, its... we can make sure those two documents are consistent with each other. 

And, like any draft guidance, it will be open to public comment. This one we anticipate at 

least 60 days for public comment. And as a result of that comment, we will review those 

comments, amend the text and publish the final guidance. And then, the final document 

would be incorporated in the Program Handbook and available to the public. 

That is it. I am happy to answer any questions you might have. 

Barry Flamm: Any questions for Lisa? Zea.

Zea Sonnabend: Thank you, Lisa. That was very informative. Have you anticipated at all that the 

publication of the guidance will necessitate a re-review of some things that are already on 

the list but may not have been classified in alignment with the new guidance? 

Lisa Brines: Yes, we have anticipated that question. We are not clear exactly how many 

substances might need additional review. We anticipate that the guidance will be 

consistent with most of the decisions that are already on the list, but there might be a few 

outliers that need to be looked at by the Board again. 

Barry Flamm: Jay? 

Jay Feldman: Thank you. Thanks, Lisa. On the issue of significant residues, could you go over 

that again? Or I am not sure I caught what you are saying on that, if anything. 

Lisa Brines: Sure. Yeah, so, you may have noticed that we did not indicate, use the term 

significant residues at all in this presentation. We do not anticipate using those terms 

within the guidance. So, I know this will be on the, this is on the agenda for later this 
Meeting Of The National Organic Standards Board

May 23, 2012

12

morning to talk about significant residues. But, we think that we can meet the intent of 

the Board’s recommendation on classification without the need to define what a 

significant residue is. 

Barry Flamm: Any other questions for Lisa? Thank you, Lisa. Next, Jennifer Taylor, Materials 

Chair, will present the initiatives and proposals from the Materials Committee. 

Unknown Female: [Inaudible]

Jennifer Taylor: Thank you. Thank you, Barry. Lisa, could you please provide the update on the 

petitions?

Lisa Brines: Sure. Thanks, Jennifer. I guess you are not done with me yet. You can go back to 

the slide, please. Thank you. 

So, in general, at each of these meetings, the Materials Committee, within the section of 

the Materials Committee, we give an update to the Board and to the public on what

petitions have come in since the last Board meeting. So that is the purpose of this, and to 

just to give a couple of reminders on process. 

So, for the Crops Committee at this meeting, they will be addressing the one listing for 

Sunset, which is still remaining for Sunset 2013, that is the List 3 inerts. There is still an 

out-, one outstanding petition to remove the material, which is ferric phosphate. There is 

two petitions outstanding for inert ingredients. And then for petitions to add a new 

substances, 601, those include bio-plastic mulch, oxidized lignite, polyoxin D zinc salt, 

and propylene glycol monolaurate. Technical reviews for all those petition substances are 

in development. The one for propylene glycol monolaurate has been recently accepted by 

the Crops Committee, so that is available to the public on the NOP website. Currently, 

there is also a supplemental report in development regarding the petition to remove ferric

phosphate, but that is of limited scope.

For Livestock Committee, they are not addressing any petitions at this meeting. There is 

one petition to amend an annotation under consideration which is for methionine. There 

are two petitions to add a new substance. One is nonanoic acid, which is also known as 

pelargonic acid, and there is a petition for pet food amino acids as well. There is one 

technical report in development for the pet food petition. The nonanoic acid technical 

report was accepted by the Livestock Committee and is available to the public on the 

website. 

For the Handling Committee: addressing several substances at this meeting, both 

petitions and Sunset materials. We are still waiting for a petitioner response on the 

petition for Caramunch malt, which has been outstanding for some time, and since the 

last meeting, the petition for dextrin has been withdrawn voluntarily by the petitioner. 

And then there is a long list of outstanding petitions for the Handling Committee as well.

For 605, we have ascorbyl palmitate, beta-carotene as a nutrient which is separate from 

its allowance as a color, L-methionine, lycopene, nucleotides, sodium gluconate, sulfuric 
Meeting Of The National Organic Standards Board

May 23, 2012

13

acid, and taurine. And for agricultural substances with the petitions outstanding include 

barley beta-fiber, bergamot bitter orange power, lutein, and sugar beet fiber. And many of 

these are in process for technical reports. Just one note on the technical reports for all the 

petition nutrients, those drafts have all been provided to the Handling Committee, 

although they have not all been finalized yet. So that, when they are, they will be 

available to the public. 

And, one update on, for the aquaculture petitions, and this will be discussed later this 

morning. We received a number of petitions from the Aquaculture Working Group 

regarding materials for use in either aquatic animal production or aquatic plant 

production. A majority of these are still under review by the NOP so they are not posted 

on the website yet, with the exception of chlorine and carbon dioxide.

And this is just a reminder for the benefit of the audience, and I guess for the Board

members as well. The criteria used to review these petition substances and the National

List come straight from the Organic Foods Production Act and the NOP regulations. And 

I will not read these to you, but these are the criteria from OFPA are what forms the basis 

for your checklist, in terms of filling those out. They are straight from the Organic Food 

Production Act. And then there is additional criteria for the use of processing aids or 

adjuvants that are listed on 205.600. 

We do have two petitions this meeting for 606 materials, which are the agricultural. So 

the Board does have criteria for evaluating those substances that might be potentially 

commercially unavailable in organic form. 

For the Sunset materials, just as a reminder, the reason that the Board is looking at these 

again is because, under OFPA, there is a requirement that the Board look at these existing 

listings every five year to determine whether they should be renewed or not. 

And so, for the voting procedure for petition substances, those... the first motion will 

generally be for classification, either as synthetic/non-synthetic or agricultural/nonagricultural. The second motion would be for listing. And those listings are always made 

in the affirmative. So even for things that do not pass, the original motion is to list the 

substance on a certain section of the National List. And those, either motion would 

require a 2/3 majority to pass the motion. 

For Sunset substances, the classification vote is generally not needed since the substance 

is already classified unless a change is needed. The relisting motion again would be made 

in the affirmative. For our Sunset materials, where a change to the annotation is 

proposed, the Board, according to the procedures, would vote on that proposed 

amendment first, but also vote on the existing listing as a back-up to allow the NOP, if 

we need the time for rulemaking, to have that as an available option. And again, the 2/3 

the majority would be required for those motions as well. 

And I think that is it, just as a reminder, unless there are any questions.
Meeting Of The National Organic Standards Board

May 23, 2012

14

Jennifer Taylor: Are there any questions? Okay.

Lisa Brines: Thank you. 

Jennifer Taylor: Excuse me. I am sorry. I had, I am having computer problems at my computer 

work this morning, and it is not working now so. I have got a small PowerPoint 

presentation. Thank you, Lisa. Thank you, Barry. 

I thought it might be good to start this morning with a review of some of the general 

comments. The comments found in the general category. These are written comments 

that the public, consumers, stakeholders provided in regard to our recommendations and 

discussion documents in regard to the Program in general. And I won't read them all, but 

I'll start off with this one. “Please ensure that the language of the organic standards 

guarantees that organic farming products will not be harmful to human health or the 

environment.” “ I would like to state that I feel the organic standards should continue to 

be strong to protect the consumers who choose to use the products.” “There are many of 

us that wish to limit the chemicals and toxins that are currently pervasive in the food 

supply, and reduce the amount of pollution that accompanies conventional agriculture.”

“We must preserve high and strict organic standards that allow farmers to grow food the 

way it was meant to be, the way nature, not man, made it.” “Food without chemicals 

should not have to be asked for.” And this is an excerpt. “All I want to express is to 

please keep it simple, keep it honest, and keep it up front.” “Please help keep our food 

safe and clean by maintaining organic integrity. Thank you.”

The members of the Material Subcommittee include Jay Feldman, Zea Sonnabend, 

Calvin Walker, John Foster, Wendy Fulwider, and myself, as chair. 

We have worked really hard this year to identify issues that are important to the organic 

community, and to the Program. And, to examine and identify themes that are 

foundational to organics, themes that are foundational to the integrity of the USDA

organic seal. 

So, the topics that we will discuss today will include aquaculture petition update 

presentation - Jay will provide that discussion; research priorities framework proposal, 

provided by Zea and Calvin; two discussion documents, extractants and solvents 

discussion document, and significant residues and classification materials discussion 

document, both provided by Jay.

Unknown Male: [Inaudible] Sounds pretty boring to me.

Jennifer Taylor: Okay, we will begin with Jay.

Jay Feldman: Thank you. We are going to start with the aquaculture update. And as you all 

know, this is just an update. I guess what we are going to do is run through these various 

presentations, and then we will have time for discussion, I hope, at some point. Okay, 

thank you.

Comment [JMS3]: 00:45:00
Meeting Of The National Organic Standards Board

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15

So, this is just some background for you, for everybody. The definition of livestock is in 

OFPA. OFPA provides for a possibility of allowing wild seafood to be certified. The ‘97 

proposed rule allowed certification of confined aquatic systems, but not wild fish. The 

2000 rule removed fish from livestock. And in 2000, USDA began a process of 

developing rules for certified organic aquatic animals. 

This is how things played out in that regulatory and statutory context. An Aquatic Animal 

Task Force produced a report in 2001, based on organic principles for livestock 

management. The NOSB accepted the report of the task force and approved the following 

recommendations. No standards be developed for wild caught aquatic animals; standards 

be developed for the production of farmed aquatic animals that reflect an innovative 

approach to organic certification while remaining fully consistent with the statutory 

requirements of OFPA; and three, if standards are developed for farmed aquatic animals, 

the NOP and the NOSB should use the task force report as guidance. 

As a result of work by the AWG, composed of NOSB members and outside people with 

experience and expertise in the field, a series of detailed recommendations were passed

by the NOSB between 2007 and 2008. Except for aquatic plants, which was bought by a 

Joint Committee of Crops and Livestock, all were brought to the Board by the Livestock 

Committee. 

Petitions: The AWG has submitted petitions for the use of 10 synthetic substances or 

classes of substances in aquatic agriculture. Three of these, chlorine, carbon dioxide and 

vitamins, have been sent to the Materials Committee for consideration. The Materials, I 

mean the Committee has considered the petition for carbon dioxide and vitamins, has 

found them insufficient, and awaits further documentation. So, that process is ongoing. 

We expect that soon. 

As noted in the discussion document in 2011, the Materials Committee learned this from 

petitions. We need different criteria for open as opposed to closed systems. Petitions need 

to include the use pattern of the material, quantity, how it is added to the system; 

aquiculture-specific information, for example, on environmental fate, interactions with 

other substances and organisms; and aquatic, sorry, aquaculture-specific reference to 

applicable law and regulations. 

We learned from petitions regarding carbon dioxide and vitamins two other things. 

Petitions should cite references that are relevant to the use of the material in an aquatic 

system as well as petitions and TRs for crops and livestock. We need to deal with specific 

materials, not categories, at least until we get the material evaluation process worked out. 

And this is what we heard from the public. That... We summarized this in Savannah. So 

we have that on the record, that commenters urged the NOSB to review aquaculture 

materials using organic principles, particularly the concern for the surrounding ecology, 

use of synthetics in non-routine situations and not for systems functions, and using the 

underlying ecology to feed plants and animals. 
Meeting Of The National Organic Standards Board

May 23, 2012

16

Commenters strongly urged the NOSB to distinguish between closed and land-based 

systems in evaluating materials, and we were urged to consider differences between 

herbivorous and carnivorous – I did that last time too – fish in feed requirements and 

potential for bio-accumulating toxic chemicals. 

Commenters urged the NOSB to evaluate materials in light of properties of aquatic 

systems, in addition to questions normally asked when examining materials. Questions 

must be interpreted to include impacts relevant to an aquaculture system, such as bioaccumulation, oxygen depletion, chemical changes that could lead to the need for 

intervention, and depletion of ambient nutrients, as well as impacts to non-aquatic 

organisms attracted to a water source. 

The Materials Committee may continue to work with the AWG to ensure sufficiency of 

petitions, on the work... or the work may be transferred to the Livestock Committee and 

the Crops Committee for the plant materials, which seems to be the direction things are 

headed in right now. Committees will incorporate public response and advice of experts 

in aquatic biology and aquaculture into development of questions for TRs for aquaculture 

materials. TRs will be requested as needed. The Materials Committee will work with the 

CC and LC on materials. 

So, that is the update. And I think we will leave it there. I will hand the gavel here over to 

Zea, who will talk about research priorities, and then I will come back and talk about 

extractants and significant. Thank you.

Zea Sonnabend: Thank you. Michelle, could we have the research document up, perhaps? Well, I 

have been in the fortunate position so far of being the point person on things that have 

had relatively little opposition. The GMO letter, I think, was crafted in a way that 

everyone could agree with. And likewise, this research priorities document, which has 

been quite some time in development, has reached the stage where pretty much everyone 

is happy with both the criteria and the procedures of it moving forward. 

So, just to tell you how we arrived at this place, I mean, you can..., I am assuming that 

everyone who was interested read the document, and perhaps you read the discussion 

document from the previous meeting. But, we looked at the few public comments from 

the previous meeting, which had some very good suggestions. And, that resulted in us –

where did my mess go? – okay, could you scroll down to the recommendation part of it, 

Michelle? That resulted in us using the same criteria that were in the discussion document 

with one more added to it, which it would be to particularly focus on things that are, 

research needs that are relevant to assessing the need for alternative cultural, biological,

and mechanical methods for materials on the National List. Because, after all, that is 

usually where our lack of research comes up in discussion when we are discussing a 

material and we do not have a good handle on what the alternatives really are, and what 

they can do. For... And then, we need more research on it. 
Meeting Of The National Organic Standards Board

May 23, 2012

17

So, we recognized that there..., not only are we identifying research topics, but, along 

with those topics, a lot of times, we have to frame questions. And these questions may be 

framed for all different types of researchers to do research on. So, I use the example of, 

from a couple of meetings ago, the antibiotic use in apples and pears. And so, someone 

could do market research on consumer acceptability of different, of resistant apple 

varieties, for instance. And then, apple breeders could do research on finding resistant 

varieties. And agronomists or chemists could do research on, you know, other materials 

that may be used, useful, maybe microbiologists would get a role. So that there are some 

key, targeted questions framed, so that if I am any type of researcher, and I am looking 

around for a high-priority topic to apply for a grant, I can develop a research project, and 

then I can submit this as evidence to the granting agency that the NOSB really needs this 

research done. And hopefully, that would carry some weight with the funders who like to 

fund organic research. 

So, we created a little structure which would be under the heading Process Framework. In 

this, the Materials Committee will collect all the research topics as they come up in 

meetings, and from the other committees, referred from the other committees. Each 

NOSB committee will have to identify their research questions on their own topics that 

they have been uncovered in the course of doing the committee business, and for the 

amount to the Materials Committee. 

We will keep... We, the Materials Committee, will keep a running list of all the different 

topics. And then, once a year, before the fall meeting, we will try and identify the top 

priorities of that list. I did not put a set number of top priorities in there, but, I expect that 

we are going to try and definitely keep it under 10, and, you know, maybe as few as five

– somewhere in the five to 10 range. And we will flush those out with some appropriate 

research questions in conjunction with the committees. 

We will keep the rest of the list and make that public, also, the things that did not make 

our top five or 10, because there may be some obscure topics that come back in the future 

that rise to the top, shall we say. And, we will make that public for researchers and the 

public to use. So then, at the fall meeting each year, we will present the top topics. And, 

ratify them. And then, we have a dissemination phase of how we are going to make those 

topics and questions known to the organic research community. And so, that is presented 

here. 

Now, Calvin is going to talk a little bit about what types of public comment we got on 

this, and how the proposal will move forward.

Calvin Walker: Thank you, Zea. I will be very brief. Zea actually capsulized we have seen in the 

public written comments, and it is definitely good to be on a committee where the public 

was 100% for what we was trying to do. Not a lot of acrimony. And I think, the key thing 

that came out of this is that stakeholders want to see research. And, we have seen two 

different tracks. One dealing with a individual material topics, such as GMO, terracycling, etc. But, there was a large number of stakeholders also ask that we look at 

organic management systems. Look at cultural, biological, and mechanical type research 

Comment [JMS4]: 01:00:00
Meeting Of The National Organic Standards Board

May 23, 2012

18

that deals with organics. So, I think that those comments was very valued. So we hope 

that we will be able to do that.

Also, as I note, we can actually start doing some of these things right now. For a person 

who have had three organic grants funded, and those of us who know, many times your 

topic is actually -- when it goes through reviews, the topic has a lot to do with it. And, I 

found it very helpful to put the word organic in it. As opposed to, if I am doing something 

with animal science, it may not be the best to not put organic in that topic, because, it 

may get to reviewers who may be conventional agriculture. And many times, these 

agencies select reviewers based on your topic. Or what you determine where they should 

go. So, I think research priority will go a long way in dealing with a lot of these substance 

that we see coming in on the..., that we have been asked by stakeholders to take off the 

list, or add to the list. So, I think two tracks research priorities need to be a look at the 

organic management system, as opposed to individual items. [inaudible]

Zea Sonnabend: Okay, thank you, Calvin. Are there any questions from the Board before we 

move on? Okay, thank you. Oh, question down there.

Nick Maravell: Yes, Zea, I just had a question on one of the criteria relevant to assessing the 

need for alternative cultural, biological, and mechanical methods to materials on the 

National List. I am to understand that what you are saying is assessing, what are the 

alternatives to materials on the National List that could be achieved through cultural, 

biological and mechanic methods? Or am I reading that incorrectly?

Zea Sonnabend: Well, it is not just what are they, but how well do they work. And that is why 

we say relevant to assessing, not assessing, because, many of the alternatives are very 

situation specific, especially biological methods. So, a certain method might work in one 

enviro- , in one microclimate, and not in another, or in one region, and not in another. 

And so, we wanted to encompass all of that, all of those types of work, research in that

criteria.

Nick Maravell: I am in total agreement. I might suggest a few more words to make that clear and 

to particularly, the concept of systems work within regions or localities or whatever. I see 

that as a systems oriented type of situation. And, we need not debate that any further. But, 

I would be happy to discuss that with you, in terms of how to tease that out a little bit 

more.

Zea Sonnabend: Okay, but are you saying we should delay the vote on this to re-craft some 

wording on it?

Nick Maravell: Not at all. What I am suggesting...

Zea Sonnabend: I do think...

Nick Maravell: As we move forward, this would be kept in mind, because...
Meeting Of The National Organic Standards Board

May 23, 2012

19

Zea Sonnabend: Yeah. Absolutely. We, Our committee strongly has a systems approach in mind. 

All of us who discussed it are definitely thinking...

Nick Maravell: Right, and that is what I would like to see, you know, highlighted here. I think 

there will be plenty of opportunity in the future to do that. 

Zea Sonnabrand: Okay, thank you. Mac?

Mac Stone: Are you all going to take this and craft a request to the public and the industry to 

seek topics and kind of formalize the request in preparation for the fall meeting?

Zea Sonnabrand: It will be on the fall agenda, yes. However, what we will be presenting for the 

fall agenda is the research needs that have come in from the past year, and people can 

submit more during the next docket. But, we won't be able to incorporate them until, if 

they are brand-new, until the next year’s thing, because we will be sifting through what 

we already know about. We will be putting in an internal call to committee chairs to, you 

know, collect and move forward their research team that they have developed so far for 

the fall meeting. But anything submitted in the next docket will have to move forward on 

the list until the next year. And actually, some of the public comment from this meeting 

on other subjects that are on our agenda said, this would be a really good topic to do more 

research on, and so, we will collect those things that have come in on this docket and 

move those onto, into the fall pile.

Miles?

Miles McEvoy: Just a process question here. In your process framework, you are proposing that 

this would go to the list of priorities or the recommendation would go to NIFA, ARS and 

NRCS and OFRF and other private foundations. In terms of the mechanism for the 

Board, the priority list would come to the Program, and then what would be a more 

impactful would be for then the Program to then send that list of priorities to these 

institutions within USDA in particular, because that is both the process that we would 

need to follow, and it would have a greater impact by following that process.

Zea Sonnabend: I figured it would be something like that. And that is why it says the Chair of the 

Board will make sure it is sent, and that means, of course, we will send it through the 

NOP. But, I did not know exactly how to word that. We did not have any guidance from 

NOP at the time we were developing the recommendation. So, do you think that is okay 

to say, make sure it is sent, in number six?

Miles McEvoy: Well, again, you can provide it to the NOP, and then we will make sure that it is 

sent to the appropriate [inaudible].

Zea Sonnabend: Okay, so we will make that wording change, and I do not even have a hard 

copy. But, Michelle, can you note down that we will say, in number six, after the 
Meeting Of The National Organic Standards Board

May 23, 2012

20

recommendation is finalized by the NOSB each fall, the Chair of the Board will send it to 

the NOP who will make sure it is sent to primary organic research. Thank you.

Anyone else? Okay, thank you very much.

Jay Feldman: Thank you. We had eight questions that went out for public comment on this. And 

just to put this in context at... Well, I can start the slides actually. At the time that we 

began this process, we had reached out to the NOP to identify this as an issue, and we... 

At that time it seemed appropriate to go ahead with this. I still think it is a valuable 

exercise.

And my hope is that we could even develop a side-by-side that incorporates some of the 

issues that are raised in this document and puts them side-by-side with the NOP

guidance, and even with the material working group proposal, as well as the NOSB

recommendation or policy that was passed by the Board, so that we can see which pieces 

are there, which pieces are missing. Because, what this document tries to get at is a 

comprehensive approach to this extractants issue. And, I believe there are some issues 

addressed in this document that were not addressed today in the NOP presentation.

So, this is the way in which we approached this whole issue. That there are limitations on 

the use of extractants and solvents used to produce materials used in crops, livestock and 

processing that are not uniform or consistent across the rule. The lack of consistency 

leads to problems in classification and listing. The Materials Committee seeks to clarify 

the issues around the use of extractants and solvents to ensure more informed and logical 

decision making across numerous NOSB committees and materials review. The Materials 

Committee asked the NOP if the committee could continue to work on this issue, at least 

at the time, the response was yes. 

So, we addressed eight questions. What is a volatile synthetic solvent? What does the use 

of a solvent or a synthetic solvent change, or when does it change the classification of the 

material? Does the use of a volatile synthetic solvent in an ingredient mean that the 

ingredient is not permitted in organic food? This has to do with the heritage of an input:

does a prohibition against its use carry back to the origin of the ingredient or ingredients? 

The limitations on the use of extract – oh, I went the wrong way, sorry. Okay, when does 

the use of a synthetic solvent change the classification of the material? The use of a 

solvent, synthetic or non-synthetic, may result in production of a non-agricultural product 

from an agricultural substance under the definition, under the current definition. Though,

if the definition passed by the NOSB in 2009 were written into the regulations, it would 

not. And again, we have to weigh this or compare this to what was presented to us earlier 

in this session. The use of a synthetic solvent can change the classification of a material 

from non-synthetic to synthetic, if the addition of the synthetic solvent results in chemical 

change, or if the material contains a significant level of the synthetic solvent. And that is 

the NOSB policy. It uses those two concepts of chemical change, and significant level of 

synthetic. 
Meeting Of The National Organic Standards Board

May 23, 2012

21

Does the prohibition against... Does the prohibition against the use of volatile synthetic 

solvents carry back to the origin of ingredients? And this is where 205.270 – two seventy 

– comes in. It is not clear whether the use of a volatile synthetic solvent in an ingredient 

that is subsequently used in another product disqualifies the second product as being 

labeled organic. 

Public response: We have got several individuals who advocate for clarifying the policy 

and maintaining a prohibition on the use of volatile synthetics. CCOF says any policy 

made must be achievable by certifiers and MROs. Several groups urged, public interest 

urged the Board to make the prohibition on volatile synthetics solvents in processed 

foods clear and consistent, to clearly define volatile synthetic, and re-write 270. The trade 

groups, for the most part, asked to postpone consideration until the guidance is published. 

So, the first question was around this issue of should volatile synthetic solvents be 

defined, especially in relationship to 270? Should we make a distinction between 

different types of solvents? If possible, reference to a standard scientific or regulatory 

definition is preferred. Should the toxicity of a volatile synthetic affect how it is treated in 

classification? And does the supercritical carbon dioxide meet the definition? 

And we received a fair amount of good response to this, I think, from across the groups. 

Beyond Pesticides, NOC, and Cornucopia supported the suggested definition. Beyond 

Pesticides suggested a clarification of “a volatile synthetic solvent is a synthetic chemical 

with a boiling point of less than 287 degrees Celsius at standard atmospheric pressure that 

can dissolve another substance”. All three organizations and Equal Exchange agree that 

supercritical carbon dioxide is not a VSS. 

OMRI says, since handlers – oops – of “organic” and “made with organic” products can 

only use synthetic ingredients and processing aids on 605(b) and 270(c)(2) establishes 

that an organic handler may not use, as Lisa told us, a synthetic volatile solvents in 

producing a final certified organic product, a definition for volatile synthetic solvent 

would only be needed if such a substance was petitioned for addition to the National List

under 605(b). OTA reminds us that 270(c)(2) applies to synthetic processing aids as well 

as volatile synthetic solvents, and referred to a clarification formerly posted on the NOP

website. OTA urges the NOP to formally clarify 270(c)(2). 

Question two: is there distinction between volatile synthetics for extraction versus 

volatile synthetics used for other purposes? Solvents are also used for purposes other than 

extraction, such as purification of a substance via crystallization. Solvents can also, are 

also common inert ingredient in formulated pesticide products. 

Beyond Pesticides and Cornucopia answered that the prohibition is against volatile 

synthetic solvents, however they are used. OTA points out that historically in the context 

of making synthetic/ non-synthetic determinations, the focus is on extraction and 

manufacturing and whether or not a synthetic substance chemically changes the nonsynthetic substance. 

Comment [JMS5]: 01:15:00
Meeting Of The National Organic Standards Board

May 23, 2012

22

And then Question three: Should the process of extraction change the classification of an 

ag product? Does it matter whether the extractant is synthetic or non-synthetic? And we 

did not get much response to that. We did not get any response to that, I guess, because 

people integrated answers to that in their other responses.

Since – this is question four – since 270 organic handling requirements explicitly 

prohibits VSS, oops, the handler of an organic handling operation must not use in or on 

agricultural products intended to be sold, labeled, or represented “100% organic”, 

“organic”, or “made with”, or, in or on any ingredient labeled as organic. A volatile 

synthetic solvent or other synthetic processing aid not allowed under 605. 

Except that non-organic ingredients in products labeled “made with”, are not subject to 

the requirement should consumers expect that non-agricultural ingredients identified as 

“organic” be produced or extracted with the same restriction. And that becomes a key 

issue, I think, given the range of issues we have heard about today. So, I am going to 

repeat that. Except that non-organic ingredients in products labeled “made with organic”

are not subject to this requirement, should consumers expect that non-agricultural 

ingredients identified as “organic” be produced, inorganic, be produced or extracted with 

the same restriction. And then we asked for rationale. 

And this is where the public interest side basically said that we should re-write 270, 

which has been referenced today extensively, skip down, to a volatile synthetic solvent or 

other synthetic processing – this is the last paragraph – aid not allowed under 605, except, 

that non-organic ingredients in products labeled “made with specified ingredients or food 

groups” are not subject to this requirement if the use of the volatile synthetic is revealed 

in the ingredient statement –which is not happening now. 

So, Beyond Pesticides put this in their testimony, which I think helped me, I mean, you 

know, I did not... When we sat down to really figure out what is going on here, this is all 

complicated mumbo-jumbo to a lot of us. What is happening here? And there are two 

tracks happening. If you start at the top, and this is something that we experienced with 

DHA, actually. We start with any agricultural material. We use a vola- – go to the second 

box – we use a VSS, right? Then we have the next material, the extracted material. Okay? 

That extracted material either goes to a certified handler, or goes to a non-certified 

handler. If it goes to a certified handler, we have heard today very clearly, it cannot go 

into, it cannot be labeled as “organic”. 

But, if it goes to a non-certified handler, as I understand it, as Beyond Pesticides explains

this, it goes to, it can end up in a USDA certified product. So, that is what the public 

interest side was saying. Well, what... Is this fair? Or I mean I do not know if that is the 

right word. But, shouldn't we have some equality of attention to the extractant or the 

extracted material whether it is handled by a certified handler or it is handled by a noncertified handler? In the case of DHA extraction, as you recall, it was handled, as I 

understand it, by a non-certified handler, so it ends up an organic product without any 

discussion as to whether – okay, we can discuss that. Okay. 
Meeting Of The National Organic Standards Board

May 23, 2012

23

And here we have it on the non-, oh, that was an agricultural. So, here we have it on the 

non-ag side. So, you are right, it was an agricultural. So, DHA would be the second 

example. We start with a non-agricultural material. We applied a VSS. We then have an 

extracted material. What we start with in that case, algae or whatever. And then, it is 

handled by a non-certified handler, and then sold at some point to a certified handler. But, 

we are talking about the heritage here. We are talking about the original ingredient. It 

is... The VSS, in all these cases, is applied to the original ingredient. If it is handled by a 

non-certified handler, it ends up in an organic product. If it is handled by a certified 

handler, it ends up in a certified product. And you can clarify this later. Or, do you want 

to do it now? 

Zea Sonnabend: A non-certified handler cannot make a product labeled organic on the front 

label. 

Jay Feldman: Right. We are talking about the ingredient, ingredient B, put into a certified 

organic product. That is what this chart is talking about. Not the... The product itself 

cannot be labeled organic, we understand that. It can be put into...

Zea Sonnabend: A made with organic.

Jay Feldman: Right, it can be into a product that is made with organic. So, the question is, should 

we try to fix that? Or, does it need fixing? And that is what we are going to hear from 

later today, I guess. The solution being proposed here is that whether it is ag or non-ag, if 

it is extracted with a VSS, whoever handles it, it needs to, you know, it needs to either get 

on the list or it should not be used, or, we have to have some process of keeping it out of 

organic. Or, some people believe we need a process of keeping it out of organicallylabeled products. 

Okay. We are obviously not going to get through all of this. So, that was the main 

distinction I think I wanted to bring up between this issue and some of the other issues 

that have been raised by the Program this morning. But, I just want to provide you with 

the OTA response, which we will hear directly hopefully from them, and OMRI. OTA

says that this does not make sense because non-agricultural ingredients are not identified 

as organic. And we will talk about what we are trying to identify as organic. But, OTA

says it is important to note that the heading of 605 refers to ingredients only. Under this

section, a certified handler is allowed to use the listed substance referred to as ingredients 

in the 5% or 30% of the certified product. So, it would be the “organic” or “made with 

organic” label. The reference to 270(c)(2) is significant to the handler of a certified 

operation because it clarifies that synthetic solvents and synthetic processing aids used in 

or on products labeled “100% organic”, “organic”, or “made with”, must also be on 605 

of the National List.

I am going to stop there because I want to run quickly through the significant discussion 

piece as well. And I think the rest of this presentation overlaps, to some degree, with the

significant issue, which may be a non-issue, given that the NOP believes that we may not 
Meeting Of The National Organic Standards Board

May 23, 2012

24

need to be concerned about that word. I am going to be really interested to hear from the 

industry side on whether they feel comfortable with dropping the significant language. 

Jennifer Taylor: Excuse me. Excuse me, Jay. The Program has a statement.

Jay Feldman: Okay.

Emily Brown-Rosen: We would just like to reiterate what was said before in Lisa's presentation 

about the use of synthetic solvents under 270(c). So basically... And I think the little 

diagram there which made a distinction between the certified handler and non-certified 

handler was pretty confusing and inaccurate. Basically, a non-organic ingredient, you can 

if it is on 605 and is reviewed by the National Organic Standards Board, you consider 

solvents in the manufacturing process. There is no prohibition – [cough] excuse me

[whisper: could you get me some water?] – there is no prohibition if you review it as part 

of the process, if you do want to restrict solvents in a non- organic, non-agricultural 

substances on 605, then you need to annotate that on the list. In non-organic agricultural 

ingredients and made with organic products, so, in the 30%, they are not restricted either. 

They can have been produced with synthetic solvents. This is the way the rule is written

now.

Non-organic ingredients that are listed on 606 for use in organic products, they may have 

been produced also with synthetic solvents or processing aids unless the NOSB

specifically annotates it. So, the NOSB has moved to annotate things like colors on 606. 

So, that is the framework we are working with now. So, you know, we do not need to 

make suppositions about if the handler is certified or not. That does not seem relevant.

Jay Feldman: Right. Well, what this discussion document is trying to get at is whether this 

should be a uniform restriction. This was the question that was asked in using volatile 

synthetic substances in extraction. And, if there was to be a uniform prohibition or 

restriction, we would not, as a Board, be negotiating between hexane and some other 

equally hazardous synthetic, volatile synthetic organic - It would not matter who... -

material. It would not matter who handled it, whether it was a certified handler or was a 

non-certified handler. 

There is a distinction in the law, which has really not been fully vetted, that allows 

ingredients in organically labeled or certified products - these are heritage ingredients, 

precursor ingredients - that have been extracted with volatile synthetic organic. And I 

think it, we experienced, I experienced a frustration on this Board in getting to a 

discussion point, finding out that there was a long list of volatile organic, or volatile 

synthetic substances utilized in the production of this ingredient, even though there was 

another equally effective ingredient that was produced without that long list of volatile 

synthetics.

And we, yeah, we checked one off on the list. But, what this discussion document was 

asking the community is, whether we could come up with a uniform way, across the 

board, of addressing the use of volatile synthetic substances. So, yes, it is confusing. But, 
Meeting Of The National Organic Standards Board

May 23, 2012

25

this is a reality, unfortunately. And the distinctions that are in the rule, I think, make it 

confusing. What we could discuss here today is whether we could eliminate those 

distinctions, so that the consumers know that volatile synthetic substances are either not

used or prohibited, or are used in some way that this Board deems acceptable in a 

uniform type of way. And I hope we can discuss that further as we move through this. 

But, I have four minutes to go through the other document, which I am obviously not 

going to get through. But, I do not want to hold this up. So, thank you for that, and I hope 

that we can discuss it further, Emily. I appreciate that comment.

So, again, what we are faced with as a Board is the fact that we have a policy on the 

books that is very clearly stated that chemical, that chemical change is, or synthetic is 

defined, synthetic substance is defined by two elements. One is whether there is chemical 

change, and two whether there is a significant residue of a synthetic in that product that 

we are reviewing. Those are two elements.

And, the Program, this is the first I am hearing of this, so I may have it a little bit wrong, 

of course, but the Program is suggesting that we can define chemical change, certainly, 

and that instead of specifically identifying some significant residue that would deem a 

product synthetic. So let me say that again, instead of using the term significant residue in 

a product we determine to be organic, that we can determine that there is some language 

we could utilize that identifies removal of that product to the extent that it does not have a 

technical or functional effect. Okay? So, that is the substitution for significant. I am going 

to be really interested to hear what the industry has to say about that. 

This presentation was really an attempt to provide for the Board the background history, 

especially since we have many new Board members here. But, you are getting a sense of 

the context, I hope, that this Board passed a policy in 2009. The Board came back, the 

Materials Committee came back to the Board in 2010 and asked for a definition of 

synthetic. We were unable to reach a decisive vote on that question. And, we were left 

with this question in the Materials Committee as to whether we should take this up again, 

given that we were unable to resolve it in 2010, again, consulted the program, and the 

program said, if you want to keep beating your head against the wall, have at it. But, that 

is what we did, instead of coming back with a proposal, we came back with a discussion 

document that really opened this issue up, again. And, I think we will hear from OMRI

later in terms of the, in terms of the process that they use. 

And, I just want to show you quickly here. We will see this flow chart. I hope you all saw 

this in Lindsay's testimony from OMRI, how they, and a hope that she can walk us 

through this process, because I think it will help us to understand this concept of removal 

to a functional or technical or functional effect level. But, at the end of the day, there is 

no distinction in this flow chart that OMRI uses on this question of significant. It is

simply a review. Now, I wonder whether we, as a Board, would need to revise our policy 

on this. And, I would be interested again to hear from the industry on, and the people 

associated with the Materials Working Group on this. So, I will leave it there, Mr. Chair, 

Madam Chair, and I appreciate the time to go through these. 

Comment [JMS6]: 01:30:00
Meeting Of The National Organic Standards Board

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26

Jennifer Taylor: Thank you, Jay. Are there any questions? Okay. Thank you. I believe we need to 

proceed with the public comment period. Is Grace here? Grace Marroquin? Please come 

up. 

Unknown Male: [Open mic; Inaudible]

Jennifer Taylor: Followed by Lindsay Fernandez-Salvador. [Inaudible]

Unknown Male: [Open mic; Inaudible]

Grace Marroquin: Okay. My name is Grace Marroquin, and I am President and CEO of 

Marroquin Organic international. We are an organic and non-GMO ingredient supplier. 

We have been working with farmers and suppliers from around the world for the last 22 

years. 

Today, I am here to talk about yeast. Naw, I am just kidding. I promised I would come 

back once our yeast petition had moved through the Board. Today, I am here to give the 

NOSB and Program a progress report on the results of some decisions and changes.

I want to say thank you for doing the right thing with the organic lecithin. Rule change

went into effect February of 2012. I am happy to report that, as of today, there are now 

three suppliers of organic lecithin and, in six to twelve months, there may be another two. 

Bravo. This is how it is supposed to work. The petitioner was not so happy, but as he 

shared with me, it is the pioneers that take the arrows and the settlers that get the land. 

Our yeast petition took almost 7 years to move through the review process. Finally, an 

annotation went into effect and stated that, if yeast was being used for human 

consumption, organic yeast must be used if available. This rule change goes into effect 

October 2012. As expected, I am now pulling an arrow out of my back, because another 

yeast company is close to launching organic yeast. 

I applaud the Board and Program for taking the steps to uphold the principles of organic 

preference, which results in the growth of the organic industry, supports continuous 

improvement, and in the end, benefits and supports our organic farmers and consumers 

and the planet. 

With that said, I want to recommend that the Board exercise caution when reviewing 

ingredients to be taken off the National List. Many of us can appreciate the complexity of 

reviewing materials and applying the criteria required by OFPA and the NOP regulations. 

We urge you not to take an overly proscriptive approach and be sure that alternatives are 

widely applicable and viable when considering renewal or approval of materials.

Thirdly, research and evaluate the impact of the removal of one ingredient will have on 

the farmers and on the trade. Please keep in mind that you are not just removing one 
Meeting Of The National Organic Standards Board

May 23, 2012

27

ingredient, but there is a watershed effect, such as in the case of carrageenan. If there are 

no alternatives and if companies cannot make a final product organic, they may 

downgrade the product. This could affect sales of organic sugars, soybeans, rice, 

almonds, milk and fruits, just to name a few. And who do you think loses besides the 

manufacturers? Yup. It is going to be the farmers, and consumers, and in the end, it is the 

planet. Please hold on decisions until you are truly sure you are making the right 

decision.

The use of annotations can be positive actions towards continuous improvement. It is not 

fair to hold organic ingredients in limbo while we decide the meaning of life, ag versus 

non-ag, synthetic versus non-synthetic. Flavors are an example of an ingredient being 

held in limbo. Keep up your efforts to develop balanced, pragmatic recommendations and 

come to decisions that stimulate growth and integrity within the organic sector. Please do 

not let the perfect be the enemy of the good. The future of the planet is at stake. The 

future generations will appreciate –or suffer – our legacy. Thank you for all your hard 

work and consideration.

And I may add three minutes is way too hard to do this. It is stressful for us slow talkers. 

Thank you. 

Jennifer Taylor: Thank you. Any questions? Thanks. [Inaudible] Could Dragon please come up? 

Thank you.

Lindsay Fernandez-Salvador: Thanks. Well, first of all, I would like to say thank you for 

providing this little stepstool for us short people. [Laughing] I did not want to be a bobble 

head here. 

Unknown Male: [Laughing]

Lindsay Fernandez-Salvador: While they are getting up my presentation, that is supposed to start 

with a comic so that we can get through this difficult stuff with laughter, I will introduce 

myself.

My name is Lindsay Fernandez-Salvador. I am the program director at OMRI. I wanted 

to talk a little bit about significant residues and about how OMRI currently thinks about 

significant residues. And I also see OMRI’s role today as providing real-life examples so 

that some of you that are not familiar with this type of process and thinking can wrap 

your head around these really difficult complex issues. Next. 

This may look complicated, but this is how I train a lot of industry members about how to 

do material review, what material review looks like. Thank you. We are not going to go 

through this entire thing, but I wanted to show it to you to show that there is an actual 

step-by-step process that one can take to determine how significant residues come into 

play during material review and during the process in general. And I am going to give an 

example of how we look at it in two different aspects.
Meeting Of The National Organic Standards Board

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28

So we are really going to just use question number one there: are there ingredients within 

ingredients, and follow that flowchart through to the end. 

How do you -- I really do not know. I cannot see this. Sorry. Thanks. Okay, next, thanks. 

Oh, that is a happy thing. I am so [Laughing] Just go through to the next slide. Just keep 

clicking. Sorry, folks. I completely forgot about that animation. Okay. 

So, in the one example, feathermeal is used as a compost feedstock. And the feathermeal

has potassium sorbate. It is a preservative. Okay? So are there ingredients within 

ingredients? The answer is yes. Is that ingredient synthetic on the National List? Is 

potassium sorbate on the National List? No, and it is not non-synthetic. So, you want to 

go to number two and you ask, is it present in the final product? If it is using as a 

compost feedstock, it is going to be consumed during the composting process. That is 

called a removal step for OMRI, so we would move on to question number two next. 

Yeah. Okay. Thanks. Okay, and that is it. Keep going. Sorry, folks. I completely forgot 

about this. 

So, the removal step can be anything, based on chemical properties of the substance. 

Right? So, it would not be an analysis after the removal step. We would not look at the 

lab analysis for most cases. So, it could be evaporation, acid-base precipitation; it could 

be consumption; it could be metabolism by microbes; washing. A lot of different things 

act as removal steps for lots of different materials. It is based on knowledge of the 

material, plus the specific manufacturing process, which it is being removed from. And, it 

requires deep chemical knowledge of chemistry, biology, and geology. I did not get to go 

through that. Thanks.

So, this is just feathermeal as a compost , as a ingredient in... 

I have got to stop, sorry. I cannot get through this. I am sorry. So we can go through it in 

general if people want to ask me about it later. Sorry. 

Jennifer Taylor: Okay. Thank you. Jay? 

Jay Feldman: Could you continue?

Lindsay Fernandez-Salvador: Could I continue? Okay, thanks. 

So, feathermeal used as an ingredient in a blended fertilizer: If it is being mixed into a 

blended fertilizer, there is no removal step for that potassium sorbate. So therefore, it is 

just been diluted down. So, OMRI would currently prohibit this particular ingredient, 

okay, or this particular product. Because, it is not removed, it is in a presence of 4 to 5 

parts per million. So, the next slide. 

So, our really significant question for us is, is 4 to 5 parts per million significant? Is it a 

significant residue? And so, what we really want you to take home today is that OMRI
Meeting Of The National Organic Standards Board

May 23, 2012

29

does support evaluating residues based on the functional and technical effect on the final 

product. So if you were to look at both types of compost feed stock versus blended 

fertilizer with feathermeal, both of those would have insignificant residues based on this 

new approach of looking at it from a functional and technical effect on the final product. 

I think that is it. Yeah. Well, those are take-homes from other things. So, I won't spend 

time on that.

Jennifer Taylor: Thank you. Zea? Do you still have your question?

Zea Sonnabend: It was the same as Jay's, to just ask Lindsay to continue. 

Jennifer Taylor: Oh, okay. Thank you. Max?

Mac Stone: Lindsay, can you give me a visual of a part per million? Like, one dollar bill and a 

million would be a stack how high? Or one marble would fill this room? Do you have 

some sort of visual on what parts per million looks like? 

Lindsay Fernandez-Salvador: Yeah, it is a needle in a haystack. [Laughing] 

Crowd: [Laughing]

Jennifer Taylor: Okay, I am sorry. Jay? Thank you.

Jay Feldman: So do we need a definition of technical and functional effect? Is there something 

that you reference when you use those terms? 

Lindsay Fernandez-Salvador: Well, currently we do not use these terms, okay. But if we were to

use these terms, we would look at the technical and functional effect of that particular 

ingredient. So, in the case of potassium sorbate, say, the functional effect is a 

preservative. So if it was having a preservation effect in the final blended fertilizer 

ingredient, then we would prohibit it. But in that case, at 4 to 5 parts per million, that is 

just below industry standard for any preserving effect. 

Unknown Female: [Inaudible whispering]

Jay Feldman: Okay, so it does not apply to a technical effect, say, on environmental impacts or 

human health effects? I mean, you know, from the consumer's perspective, there is a 

concern about an effect to the organism, to... Whether you have a visual of one drop in an 

Olympic size swimming pool or the Atlantic Ocean, you know, science can hopefully 

now tell us that the exposure level has some effect. There may be uncertainties in there, 

but you know, we... To answer the consumer question, I understand the issue of effect on 

the product’s operation or, you know, how it functions, but... Do you see what I am 

getting at? Do we have a way of evaluating the effect on organisms and the environment? 
Meeting Of The National Organic Standards Board

May 23, 2012

30

Lindsay Fernandez-Salvador: That... You know, I really cannot answer that question because 

currently that is not how we review. I am just saying that we could support that going 

forward. If that was part of the technical and functional effect, that adds a significant 

level of complexity that would require some significant research on our behalf to 

determine, what are these substances that have some environmental effect, and at what 

level do they have that environmental effect?

Jennifer Taylor: Yes, Zea? 

Zea Sonnabend: Lindsay, would you describe how OMRI would treat the same 4 or 5 parts per 

million of potassium sorbate if you were to review it for a handling material, say an 

enzyme used in processing, where that preservative would fall under the other 

ingredients? 

Lindsay Fernandez-Salvador: Yeah. That is a good question. Currently, OMRI...Because they 

are a little bit different in the handling ingredients the way that the standard of identity 

works for those sorts of types of materials, we understand that a lot of time there are other 

ingredients in there. So, what OMRI does is that we look back to the TAP review or the 

technical review, and we look at what the NOSB reviewed and we try to understand, 

were there other ingredients as part of the review. And, if the NOSB did in fact review 

preservatives as part of that ingredient, of enzymes or possibly agricultural ingredients, 

and they chose not to annotate that material, then we will allow those other ingredients.

But, if the technical review does not make any mention of other ingredients, like the 

enzyme technical review does not, we would not allow that material, that extra other 

ingredient. 

Jennifer Taylor: Any other questions? Jay? 

Jay Feldman: I am really trying to understand this handler issue, and the ingredient within 

ingredient, which I do not think is still clear to many of us.

Are there indeed two paths one can go through to get into an organic, to be an ingredient 

in an organic product? One through a certified handler, and one through a non-certified 

handler? And, are those two paths subject to different degrees of review and allowance at 

the end of the day in a certified organic product or made with? 

Lindsay Fernandez-Salvador: I am sure there is. I am sure there is because certifiers are human 

beings. They are all human beings reviewing these materials and one certifier may look at 

something and then put it differently. So I am sure that there are different pathways. 

Jay Feldman: Yes, I mean, I guess I would like to get at this question of whether this is a real 

issue or not, that there could be a need for uniformity across the system of review when it 

comes to volatile synthetic substances. That indeed, we do not have uniformity now, in 

terms of how we review ingredients within ingredients, and that for us as a Board to 

review each volatile synthetic every time it comes up in every material before handling or 

Comment [JMS7]: 01:45:00
Meeting Of The National Organic Standards Board

May 23, 2012

31

crops or whatever. It seems to me we could as a community agree that regardless of how 

it is used and applied, you know, used in extraction for non-ag or ag, that at the end of the 

day, even if you go to the functional technical equivalent definition, hopefully applying 

to adverse impacts on organisms and environment in addition to impacts on the 

functional effect in the product itself, even if we were to agree on that, could not we still 

benefit from a uniform definition and application of VSS review and restriction across 

the board? Ag, non-ag. 

Miles McEvoy: Just to clarify, there is one standard, one regulation. We expect the certifiers to 

follow that for all ingredients, whether it is coming through a certified handler or there is 

an intermediate non-certified handler involved. There is one standard. There may be 

different ways that certifiers are conducting their reviews, but, there is one standard. They 

are expected to follow that. So if there is inconsistency, we will work with the certifiers 

to ensure it is a consistent process. But, there is not two ways that ingredients are allowed 

in organic products. There is only one way. 

Jay Feldman: Do you believe that this Board should be reviewing individual volatile synthetic 

substances and each handling product as we looked at one of many in DHA, which 

seemed difficult and confusing and unsatisfying, in terms of the end result? Do you think 

there is a better way of creating some uniformity in how we look at volatile synthetic 

substances? 

Miles McEvoy: As we wrote to the Board in the fall, we want the Board to work on a 

comprehensive policy on other ingredients, which would include synthetic solvents that 

are used in creating products that are on 605. So, yes, it is important to have a 

comprehensive way of approaching other ingredients on 605 materials. It really has not 

been done in the past. It has been a case-by-case basis. In the meantime, you need to look 

at it on a case-by-case basis as you are reviewing substances for either Sunset or addition

or withdraw from the National List. So, both are true. You should look at other 

ingredients for all categories. Comprehensive policy on that is also important.

Jay Feldman: Okay, well that helps because I did not realize, I was not clear that solvent or 

extractants were included in the other ingredients discussion. And hopefully, we can put 

that on the work plan for the Board. Or someone said it might be on the work plan 

already. So thank you. 

Jennifer Taylor: Thank you. Dragon. Could Robin please come forward?

Dragan Macura: My name is Dragan Macura. I am the Chief Science Officer and part owner of 

AgroThrive Incorporated. We are a small organic fertilizer manufacturer that can very 

much be affected by the decision on the significant residues that is in front of you. Could 

you have the slide please?

AgroThrive Incorporated produces organic fertilizers from food industry and other 

organic wastes. We are very small, seven employees in all, including myself. We 

pioneered the food safety and organic integrity programs in our industry, advocating full 
Meeting Of The National Organic Standards Board

May 23, 2012

32

transparency, plant audits, and a clear way out of the wilderness that our industry was in 

only a few years ago. 

We must accept waste streams of organic materials as they come, contaminated or not.

We apply microbial and enzymatic digestion technologies to convert an environmental 

hazard – that is organic waste – to a valuable agricultural commodity – that is organic 

fertilizer – thereby, significantly improve the impact of the organic waste on the 

environment. 

Our operation takes organic wastes and other ends, that often, that often end up in the 

landfills, and converts them to materials that are excellent, that are excellent fertilizers 

and improve, that improve plant and soil health. Fertilizers drive, drive food and fiber 

production, organic and conventional. NOSB decision on significant residues will have 

huge impact on our business, thus, I offer several points of, for consideration when 

deliberating over this very important issue. Next, please. 

Consider the system in question. Feedstock for composting or organic fertilizer 

manufacturing process should be looked at differently than the food for human 

consumption. Number two. 

Consider mitigating or amplifying circumstances. Is there anything in the process that 

renders the substance in question more or less dangerous? For example, composting and 

or microbial enzymatic digestion will often inactivate the offending substances. If so, 

allow for the transformation or decontamination. Is anything in the process of making the 

material more dangerous? If so, take that into account. Number three. 

Consider the point of significant engagement as major point of evaluation. At what point 

in the process and at what concentration does the offending material become dangerous 

to the environment, handlers or consumers? Consider the point of significant engagement 

at the point of food consumption. Next, please. 

Do not needlessly reduce, this last one, our feedstock options as we already have a severe 

shortage of organic inputs. Please remember, everything that is organic, has to be 

fertilized first. We need more organic fertilizers, not less, in order to grow the whole 

organic industry. 

Jennifer Taylor: Thank you. Any questions? Thank you. Could Gwendolyn please come up? 

Robin Seydel: Good morning, my name is Robin Seydel. I am the Membership and Community 

Development Manager of La Montanita, a consumer co-op owned by over 17,300 New 

Mexicans. And I am a member and supporter of Cornucopia, NOC, the Wild Farm 

Alliance, Beyond Pesticides, Food and Water, and the Center for Food Safety. And RAFI 

too. 

A businessperson, I recognize that you are in the weeds of rule-making minutia, and that 

some of your deliberations are beyond my expertise. I urge the NOSB and the NOP to 

take the technical testimony of the above mentioned organizations as my
Meeting Of The National Organic Standards Board

May 23, 2012

33

recommendations, but, would like to thank you for the discussion of extractors and 

solvents. 

The current rule which prohibits the use of synthetic volatile solvents only by certified 

organic handlers is extremely misleading to consumers who rightfully expect all 

ingredients in a certified organic product be produced without their use. Cornucopia notes 

the annotations to prohibit specific volatile synthetic solvents for some materials on the 

National List, but not for others, is inconsistent and adds to confusion among consumers. 

The prohibition of hexane and Martek DHA oil production, but continued use of 

synthetic isopropyl alcohol, makes no sense and shows why clarification is needed in the 

rule.

Please support the definition of volatile synthetic solvent as a synthetic chemical with a 

boiling point less than 287 degrees Celsius that can dissolve another substance. 

Cornucopia points out language in the rule prohibiting certified organic handlers from 

using volatile synthetic solvents but allowing them to purchase ingredients from noncertified handlers who do use volatile synthetic solvents is a loophole with serious 

implications for organic integrity. Organic products should be produced without the use 

of synthetic volatile solvents and this prohibition should apply to all ingredients. Please 

support the change to the language in the rule as proposed by the above groups. 

Any residue of synthetic is significant with significant defined as any known level of a 

synthetic substance in the final material, or in the environment as a result of manufacture, 

use and disposal, and should trigger review. Any materials that are produced with the use 

of synthetics must be classified as synthetics to trigger the required NOSB review under 

OFPA. 

Mr. McEvoy yesterday used the phrase consumer trust in organics. Thank you, very 

much. I could not agree more. Thanks to my decades of work in the retail organic food 

sector, I know this trust is based on consumer perception of the safe process and materials

inherent in organic production. 

As market research shows, organic consumers are a highly educated and discerning 

population. Every time you approve a possible carcinogen or an endocrine disrupting 

chemical or a genetically engineered material for use in organics, you erode that trust. 

And hence, threaten the vitality and viability of all our organic businesses. Because, 

sooner or later, we, consumers will find out that we have not met their expectations. And,

as any business person will tell you, not meeting consumer expectations is not good for 

business.

I most respectfully request that in all of your deliberations, you go slow, as they affect all 

of us. You hold ourselves to the highest standard of ethics, integrity and transparency in 

the face of any and all political or financial pressures, because, our shared organic future 

is at stake. 
Meeting Of The National Organic Standards Board

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34

Sorry I went a little over. But, three minutes, just could not get it in in three minutes. 

Sorry. 

Jennifer Taylor: Thank you. Any questions? Jay.

Jay Feldman: Welcome, real consumer. 

Robin Seydel: Thank you. It is a pleasure to be here. Thank you all for the opportunity to be 

here. 

Jay Feldman: And how many members are part of your co-op? 

Robin Seydel: 17,300. We have five locations in New Mexico. We work with 900 local 

producers around the state and have a food shed warehouse that runs trucks every day.

20% of everything we purchase and sell is local and organic, or organic. 

Jay Feldman: I know you have been around some of the meanings of the last couple of days, and 

sessions. You know, you may have heard people say that if you do this to organic or that 

to organic, if you restrict this input or that input, you will restrict the growth of organic. 

You will hurt organic. You will hurt our ability as a community to grow and expand. 

How does that comment sit with you? And how would you respond to that? Or, how do 

you think I should respond to that as a NOSB member? 

Robin Seydel: It is a really good question, Jay. And I understand the viewpoint of people who

say that we will limit the growth of organic. But, I think that if we do not maintain the 

integrity of organic, as I said in my comments, consumers will know. And we are already 

seeing consumers say, oh, organic, you know they allow all of this stuff in it now. It is 

not really organic any more. I am not going to buy organic. I am going to go local or I am 

going to go sustainable because organic does not mean anything anymore. 

So, I think, you know, we... it is a tightrope that we walk. It is a really fine line. And I 

would urge this committee to maintain the strictest standards. Go really slow. We have to 

be careful. You know the carrageenan thing. People will find out. In our next co-op 

newsletter that goes out to all those consumers, I feel held to my integrity as a person and 

in our organization to let them know that carrageenan is a possible human carcinogen, 

and that if they see that in the ingredient list in a certified organic product, they shouldn't 

buy it if they care. 

And so, I think we have to be really careful. And I think of many of our organizations and 

many of the people here feel strongly about that, that we must maintain our integrity, 

because if we do not, we have nothing. And, people will find out, and if they do not trust 

us as Mr. McEvoy, you know, most astutely pointed out, then we have nothing when we 

lose that trust. And I, for one, am all for maintaining that trust as we look at these 

solvents, and look at these chemicals and these possible carcinogens and these additives

and, as you pointed out, these ingredients within the ingredients. That was totally new to 

me. 

Comment [JMS8]: 02:00:00
Meeting Of The National Organic Standards Board

May 23, 2012

35

Jennifer Taylor: Okay, thank you. Any other questions? Thank you again. 

Robin Seydel: You are welcome. 

Jennifer Taylor: Gwendolyn, please come forward. And followed by Sarah? Sarah Ann.

Gwendolyn Wyard: Thank you. Lisa, are you my timekeeper? Okay. I want to get ready to set 

and go here. So I can just give myself a moment to time, because I really tried to time this 

to stick right to three minutes. Okay, one, two, three. Go. 

Good morning, Mr. Chairman, NOSB board members, NOP staff, and ladies and 

gentlemen of the gallery. My name is Gwendolyn Wyard. I am the Associate Director for 

Organic Standards and Industry Outreach for the Organic Trade Association. And, for the 

new members, welcome. I am also co-chair of the Materials Working Group and I serve 

on a OMRI Board of Directors. I have been in certification for 15 years with a focus on 

materials, and I have a food science degree. My comments today are on behalf of OTA, 

representing businesses across 49 states, and we represent over 6500 members. OTA is 

respect – Okay, next slide. 

OTA is respectfully asking the Board to please pull back the discussion documents on 

synthetic solvents and extractants and significant residues, and reserve any further work 

on these topics until after the NOP has released draft guidance on classification of

materials. The questions raised in both discussion documents address very critical yet

very specific challenges that are housed within the larger classification of materials

discussion that led to a recommendation that was finally passed in 2010 after ten years of 

NOSB, NOP and public collaboration. We are concerned about the discourse and the 

confusion that may be created, especially for the new Board members, if these topics are 

revisited without the full context of the 2010 recommendation, and the subsequent NOP

draft guidance. So, let's call the 2010 recommendation the whole pie. Next slide please. 

So here, this is really intended to overwhelm you. It is only half the pie. And you can see 

the arrow in the red box is pointing to a couple questions, and those couple questions are

what resulted in the discussion documents that are coming out of the Materials 

Committee. This is a decision tree, the tree that was drafted by NOP in 2005. It is being 

re-worked. This is not the decision tree that is coming out of the draft guidance from 

NOP. I want to be clear. We believe it is confusing and counterproductive to discuss 

these topics without understanding how they fit into the whole pie, and then how that 

whole pie fits into the feast, if you will, the entire evaluation of materials in general both 

at the NOSB level as well as at the MRO and certifier level. In our comments, we took 

the opportunity to answer the questions by reviewing the work that has been completed 

since 2005. Would you go ahead and just flip through those next two slides?

If you just go through, that is a lineup of all the documents that have been produced since 

2005. Go onto the next one. And I hope that you carefully review all of those documents 
Meeting Of The National Organic Standards Board

May 23, 2012

36

and, for the new members, that you really take the time to study this topic, because it is 

critical to your rule, obviously, as the NOP presented this morning. 

This is a picture of some products here – chocolate milk, chocolate pudding. All of the 

ingredients that you see up here, they are hydrocholates. They are gums. We see that they 

have similar functionality. They are produced in a very similar fashion although we see 

them placed on the National List as non-synthetic, synthetic and agricultural. Their 

placement seems to be very random so we really urge the Board to hold back on 

classifying these materials. Also relevant to these discussion materials, hold back on 

classifying them and take the opportunity to look at all these materials as examples and 

deal with them all at once and see what – and this is after the NOP has released their draft 

guidance. 

And then I just have a couple take-home messages that if you just move on to the next 

slide. 

We really urge the Board to request a training on classification materials. And, urge the 

Board and thank the NOP for the work they have done on putting together draft guidance 

and we look forward to that coming out and all of us collectively as a community 

commenting on that draft guidance. Thank you very much. 

Jennifer Taylor: Thank you. Any questions? 

Gwendolyn Wyard: Oh, could you put that slide back up there? 

Jennifer Taylor: Okay. 

Gwendolyn Wyard: Could you... Oh, thank you. Questions? Yes, Jay? 

Jay Feldman: I am just interested in your response to what you heard this morning from the 

Program, especially on the issue of significant and the functional and technical effect 

level or whatever. 

Gwendolyn Wyard: Well, I am absolutely pleased. I am excited about what we heard this 

morning. It is great to see the progress that the program has made. I think that, as they 

pointed out, they did not use the term significant. But, certainly they have addressed the 

question of the use of synthetic processing aids and synthetic volatile solvents. And, this 

idea of a removal step and a technical or functional effect, as we also heard from Lindsay, 

that is consistent with the practice of OMRI, which as we know, many, many of the 

materials that out there in use today have been reviewed by OMRI and that is the criteria 

that they have been applying. So, I appreciate what is being presented because it is 

consistent with practice, which I think is very important. 

They have also, it is draft guidance, and so, they have picked a path, and so it provides us 

with a great opportunity to comment on what they have put out there. So, that is what I 
Meeting Of The National Organic Standards Board

May 23, 2012

37

am really looking forward to is really, you know, all of us being able to take a look at 

these questions in that greater context. 

Technical or functional effect, I think there is regulatory references that we will be able to 

look to when we are talking about crop materials. We have, we have certain regulations 

in place. We have the, we have the inerts to look to. When we get into handling materials, 

we have regulatory references that are set, that determine, you know, whether or not a 

certain material has to be declared on the, an ingredient statement. There also have 

undergone a number of evaluations from FDA, USDA, in terms of their safety. So I think 

we have a lot to look at. 

Certainly, there is a refinement. And I can, you know, I can see where we may have to 

come up with some definitions of technical or functional, or at least lay out specifically 

what regulatory references are out there that we can look to. 

But, I think that we are, we are going in the right direction and we are closer than we 

have ever been before. 

Jennifer Taylor: Thank you. Jay.

Jay Feldman: Just a follow-up to that. You know, as you have heard from the consumer side, the 

environmental side, the issue of studying effect, at least as I understand, the responsibility 

of this Board is to look at effects on health, on human health, on biodiversity, on in this 

case we are talking about a food, a processed food commodity, you could be talking 

about, I guess, an extracted material that is a crop material. But, the consumer message 

that I am hearing is that the expectation is that these materials be reviewed for an effect 

through the National List process, and that anything that would circumvent that review 

would be problematic. Do you, as an industry representative, are you concerned that the 

people that ultimately are needed to make this industry grow are raising concerns that 

some ingredients may not be subject to full review for their human health, biodiversity, 

environmental effects? 

Gwendolyn Wyard: So, in this situation, OMRI would be reviewing a otherwise non-synthetic 

material. And, but, they are going through an evaluation of synthetic or non-synthetic. 

They see that a synthetic processing aid is being used. It is not just a volatile synthetic 

solvent, it is any synthetic that is used in the process. And, it is used during the process. It 

does not remain in the product in a, at a sig-, or have a technical or functional effect.

I think that we have to take into consideration the consequence of what we are really 

talking about. I mean, we cannot separate out crop materials from handling materials. If it 

remains in the product at any known level, it is going to be there. So, that would also 

include pyrethrins. I do not know how you are going to be able to separate out, and if you 

want, if you want to drill down to that level, I think we just need to, you know, if this is 

the concern, if this is where the organic sector wants to go, then we will see a lot of 

materials go away. 
Meeting Of The National Organic Standards Board

May 23, 2012

38

And I think we just need to be prepared for that outcome if that is the direction that we 

want to go to. I do not think that, I think the law requires that synthetic materials are, be 

put, be placed on the National List, but, the situation we are talking about here is whether 

it is synthetic or non-synthetic. And if a synthetic is used during this process, it has not 

resulted, we do not have a synthetic process so it is not subject to review. So, I think if we 

just stick to the law and the regulations, we have not violated anything in OFPA, as they 

are currently written. 

Jennifer Taylor: Any further questions? John? John? No? Okay. Thank you, Gwendolyn. 

Gwendolyn Wyard: Okay. Thank you.

Jennifer Taylor: Barry?

Barry Flamm: We will take a 15 minute break now and be back at 10:30 am.

[BREAK]

Crowd: [Background noise; Indiscernible conversations]

Barry Flamm: The Board is back in session. Jennifer Taylor, please continue with your 

committee business. 

Jennifer Taylor: Thank you, Barry. We have a proposal before us that needs a motion. Go ahead. 

Yes, Zea?

Zea Sonnabend: I would like to make the motion to approve the recommendation for research 

priorities as posted. 

Unknown Male: Second. 

Wendy Fulwider: Second. 

Unknown Male: [Indiscernible]

Wendy Fulwider: Second. 

Barry Flamm: There is a motion on the floor to approve - motion and second - to approve the 

research proposal. Is there ---

Zea Sonnabend: We should call for---

Barry Flamm: -- any discussion? 

Zea Sonnabend: Yeah, discussion. 

Comment [JMS9]: 02:11:00

Comment [JMS10]: 02:38:25
Meeting Of The National Organic Standards Board

May 23, 2012

39

Barry Flamm: Got any questions from the Board?

Wendy Fulwider: Colehour.

Barry Flamm: If not, we will proceed with voting. 

Wendy Fulwider: Colehour has a question, Barry. 

Colehour Bondera: Yes, just for the sake of verification. During the presentation process, there 

were a few words added to number six, and what has been moved did not include that. 

And I wanted to know if it is going to be modified at this time or not as a motion. 

Zea Sonnabend: Nick did not really add words. He suggested something conceptually, and then I 

asked him about wording changes and he said he did not have any at this time.

Oh, Myles. Myles did have words. Yes, sorry. Thank you for that correction. So with the 

correction to, the motion then is, with a correction to point number six as explained in 

when we were talking about it before, which was to send it to the NOP and they will 

disseminate it. Does the second agree with that wording change? 

Wendy Fulwider: Yes, I do. 

Zea Sonnabend: Okay. Thank you. Sorry, Colehour. 

Colehour Bondera: Thank you. 

Barry Flamm: Thank you. Any other questions or discussion? If not, we will proceed with 

voting. First of all, is there any conflict of interest among the Board? Anybody want to 

declare a conflict of interest? Hearing none, we will proceed with the vote. Calvin, would 

you start please? 

Calvin Walker: Yes.

The Entire NOSB Board : Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. Yes. Yes. 

Barry Flamm: The chair votes yes.

The Entire NOSB Board: Yes. Yes. 

Barry Flamm: Excuse me. I will revote and be last. I vote yes. The motion passes. 15 yeses, and 

zero noes. 

Unknown Male: Excuse me.

Zea Sonnabend: Barry. Correction, 14 yeses, zero noes, one absent. 
Meeting Of The National Organic Standards Board

May 23, 2012

40

Unknown Female: Nick is missing. 

Barry Flamm: Thank you. I did not know he was gone. So, the record should be corrected, it is 

14 yeses, and zero noes, 1 absent. 

Nick Maravell: I just returned. [Indiscernible] Okay, I can record my vote if you would like. 

Barry Flamm: Okay, that completes the Materials work. Next on our agenda is Crops Committee 

and Jay Feldman will take over. 

Jay Feldman: Thank you all. We are going to discuss the, an item for which we will be voting, 

which is the List 3 Inerts Sunset - List three inerts and passive pheromone dispensers. 

Hopefully, everybody has had a chance to look at this but I am going to run through the 

background on this and then we will get an update from Emily on the task force, the 

Inerts Task Force. 

In terms of where the actual rule is now, 601, synthetic substances allowed for use in 

organic crop production. This is where the inerts fits in as one of the list of materials. (m) 

As a synthetic inert ingredient classified by EPA for use with non-synthetic substances or 

synthetic substances listed in this section and used as an active pesticide ingredient in 

accordance with any limitation on the use of such substances. And, it is this next section 

that we are looking at. EPA List 3: Inerts of unknown toxicity for use only in passive 

pheromone dispensers.

So, here is some background on this, just so you, we all are understanding where this has 

been over the years. This has been an issue that has gotten significant amount of 

discussion on the Board. As you probably know, OFPA, in establishing the National List,

creates a list of exemptions for prohibited substances in organic production and handling, 

and lists the categories of substances that must be reviewed by the NOSB if they are to be 

listed. Section 2118(c)(1)(B)(i) – little i – creates a category of active ingredients that 

may be allowed, and (B)(ii) – little 2 i – creates a category of inerts that may be allowed, 

those found by EPA to be, to not be of toxic, inerts of toxicological concern. The 

categories of active and inert ingredients establish an NOSB duty to review substances. 

Okay. So, here is where the Board started getting engaged on this issue back in 1999. The 

NOSB recommended this: inert ingredients on EPA’s Lists 1 and 2 shall be prohibited by 

use, or for use in organic production and handling effective on the date of implementation 

of the final rule. This goes way back. Synthetic inerts on EPA’s List 3 shall be prohibited 

if not specifically approved by NOSB. The approval process will be completed and 

published by January 2002.

Any inert currently in use in organic production that is not approved by the NOSB will be 

banned within 18 months after the review is completed and published. To that goal, inerts 

on EPA List 3 used in products that have active ingredients approved for organic 

production shall be reviewed by the NOSB on a case-by-case basis for possible inclusion 

on the National List. 

Comment [JMS11]: 02:45:00
Meeting Of The National Organic Standards Board

May 23, 2012

41

In October of 2002, the Board passed the motion to list pheromones, which results in a

current listing for List 3 Inerts which we are voting on today. At the same meeting, the 

Board also passed a motion temporarily allowing the continued listing of certain List 3 

inerts. The NOSB recommends that any List 3 inert material forwarded for a technical 

review be allowed for use until that material is approved or prohibited by the Secretary of 

Agriculture.

When the List 3 inerts came up for Sunset in 2007, the summary of the recommendation 

said: future petitions to add, remove or renew an inert ingredient to the National List will 

need to reference a specific inert ingredient. That was the Board policy at the time. 

In then the 2007 recommendation was affirmed again in 2008 in presenting the 

discussion paper on List 4 inerts in November 2008, NOSB member Gerald Davis said, 

about List 3 inerts used in passive pheromones dispensers, quote, they – and this is List 3 

inerts – need to be petitioned individually and are subject to regular Sunset re-evaluation 

that has already been in place as an NOP policy for a couple years now, since we were 

first notified about the EPA change. 

So there was a notification that came out of from EPA that they were dispensing with the 

list process. So these lists that we actually reference no longer exist at EPA any longer. 

They have just, they are just put them all together in one list and class, evaluate them as 

other ingredients, which, actually in my other, in my other world, I have been advocating 

for for many years. So, we view that as a positive change. And part of what we are trying 

to do here is bring ourselves into compliance with this new world where we are not 

listing inert ingredients any longer in this list format. 

At this point, I am going to turn it over to Emily who will talk about how we are trying to 

deal with that issue overall in the Working Group on Inerts. 

Emily Brown-Rosen: Thanks, Jay. I am just going to quickly update what the Inerts Working 

Group has been doing since the last meeting in December. So, this is similar PowerPoint.

I will just skip through a few of these slides, but I have updated a couple points here I 

wanted everybody to see. 

So, this is our Inerts Working Group. We now have Dr. Lisa Brines, myself from the 

NOP, from the EPA, we have Chris Pfeifer and Kerry Leifer, and from NOSB Jay and 

Zea Sonnabend is our new member. So I am going to skip this background because Jay 

just pretty much went through this. 

Current timeline: We are working on a proposal, we have been, you know, it is working

for a couple of years on this collecting information and trying to figure out options. But, 

we hope to have a proposal to give to the Crops Committee by this September. Then, 

NOSB will work with that proposal and develop a formal recommend, or, the Crops 

Committee will develop a formal recommendation for the full Board. Then, NOP needs 

to receive a proposal from NOSB so that we can complete rulemaking no later than 
Meeting Of The National Organic Standards Board

May 23, 2012

42

October 17th, which is when the Sunset date for List 4 is. And that was, that was the 

original goal for the Inerts Task Force, or I should say Inerts Working Group. So that we, 

the next time that Sunset comes around, we do not have to refer to this obsolete reference 

in our CFR. 

Right now, EPA does not use these lists, as Jay has mentioned. They have instead set 

tolerance exempt, tolerances or exemptions from tolerance for pesticide residues and inert 

ingredients, and it is, whoops, it is all at the, in the 40 CFR, their part. And they have, in 

this review process, they have drastically cut down on the number of inerts available. So, 

the whole List 4 is not even available anymore. They also have a new classification.

Well, it is not new, but they expanded it a little bit of inerts as permitted for use in 

minimal risk products, and it includes what is called FIFRA 25(b) products. And it 

includes most of the former 4a’s but not a lot of the 4b’s which are still in current use for 

organic. 

This was a diagram I showed last time. The old List 4 has around almost 900 substances 

on it. We did a survey from OMRI and WSDA and EPA and we think we have only, you 

know, less than 300 in use. And most of those are non-synthetic. But, half of them are in 

25(b). And then we have about, in this little brown column on the right, we have about 

121 substances that are on the old List 4(b) that are the ones that we are, kind of, at this 

point we are trying to figure out what to do with. 

So, this is where we are, where we are currently at with the Working Group. We have 

got, sort of, two schools of thought here, two main options that we are looking at and then 

trying to figure out how to move forward. But the first option is that NOSB should 

review all individual inerts that are currently in use, and by just starting with the ones that 

are known in use, and that are not on EPA's 25(b), so we would presume that we would 

allow the ones already classed as minimal risk by EPA and then review about 121 

substances individually. So that is a lot of chemicals, synthetic chemicals, to review and 

consider for the National List. So, the group is trying to come up with a more streamlined 

proposal of grouping them in categories. And so we can maybe schedule TRs around 

certain groups. But, and then set up some sort of timetable for staggering the ones that are 

most of concern to get them reviewed and off the list first, if that was the case. And then 

have various, sort of, staggered implementation dates. But, this still means that all, these 

all have to be reviewed and all have to be on the National List and then each one of these 

things that appeared on the National List would have to be re-reviewed again in five 

years, in addition to the existing 220 substances. So we are talking about going up to 350. 

Although maybe, you know, the hope is that people would reformulate and we would not 

need all of these and it would be less, and it would be an incentive to have less. But, it 

did, does present certain resource problems for the NOP, because the technical reviews 

are running around $10,000 apiece and this is a lot of materials to review. Plus, the time 

and the staff and, you know, it is just a lot, and then the NOSB’s time.

So, second option is maybe coming at it from the other end. Allow all EPA approved 

inerts that have a tolerance exemption, but then go through and review those categories 

and specifically include on the list ones that should be prohibited and figure out a way to 
Meeting Of The National Organic Standards Board

May 23, 2012

43

identify the things that should be prohibited. In other words, identify certain chemical 

groupings that might be carcinogens, endocrine disrupters, you know, known problems, 

and then, and then go ahead and list them. And then have the option in future, as you find 

more information, to add more prohibited categories as times go on. This would require a 

lot of work, which is the problem, to like, kind of, look at the whole universe that EPA is 

allowing and trying to identify those bad actors. And then, we, it also has a problem of 

specific, you know, once you have prohibited say category, then identifying all the 

specific chemicals that would be part of that category. So there is a lot of problems there, 

too. So, but, it would have the up side of being more manageable in terms of Sunset 

review. 

So I just wanted to just give you an idea of current thinking of the task force and we are 

hoping to resolve this and come up with a consensus opinion by the end of the summer 

and turn it over to the Board. So, that is basically what we are at. And, ...

Jay Feldman: We will discuss.

Emily Brown-Rosen: We can go forward. 

Jay Feldman: Yeah. Thank you. We will discuss. You know, people will have time to ask 

questions about this. And, but, we wanted to give you an overall context of the whole 

inerts issue. Of course, today we are dealing with the List 3 inerts, which is a very narrow 

list of three or four materials. As we understand it, it is a very, it is a separate, it is a 

separate rule, it is a separate line in the rule from the List 4 inerts. And they have, for 

some reason, they have different dates for Sunsetting. 

And just to, just to remind everybody, inert ingredients are ingredients in substances that 

can be active, biologically and chemically active. The reason they are not defined as 

active, however, is that the manufacturer does not include those ingredients in the product

in an active capacity. They are not targeting an active or pest or whatever the target use of 

that product is. So for the most part, we are talking about crop materials here that are 

developed by manufacturers who list on the label all the ingredients. And if you, if you 

have ever picked up a material, a pesticide, you have noticed that the bulk of those 

materials, or the bulk of the ingredients, are listed as inert ingredients. They are the 

carrier, the surfactant, the mixing agent, the dust, the granule in which the active 

ingredient is put. And so, the purpose of reviewing this is to make a determination as to 

whether that particular ingredient in that product that we, as a Board, are allowing to be 

used, whether that ingredient has any properties, health, environmental, that we should be 

concerned about as a Board. 

So, as Emily said, it starts out being a huge list. And then you realize you can cut that 

down, many non-synthetics, and also, many that are recognized to be not, not of concern. 

So, let us, let us move on then to, back to the recommendation for this particular listing.

Okay. 
Meeting Of The National Organic Standards Board

May 23, 2012

44

So, this is what the Crop Committee recommendation proposes: That we phase out the 

List 3 inerts and passive pheromone dispensers from a general approval and move it to a 

National List review status. So, we would do that as part of our review process. It is 

understood that the former List 3 inerts require review, that are requiring review are 

limited to the, to these three substances, which I am not going to try to pronounce for you 

guys. It is also understood that there may be a fourth inert in this category that has been 

identified by the Washington State Department of Agriculture.

Okay, so the proposal acknowledges all that, and makes that change, and then establishes 

a deadline for action, an expiration date. Review and Board action is set for December 

31, 2015, allowing two years to review the petitions and act, a year for the NOP to go to 

rulemaking. And I should note that we actually have petitions for these. But, they are old. 

They are very old, because if, you know, if you go back to the Board history, you can see 

that there was an attempt made by the Board to begin this review process years ago. And 

at that point, manufacturers started submitting petitions for these materials and we never 

acted on them at that point.

If for some reason the time frames are delayed, the backup Sunset provision, which we 

always adopt on Sunsets, allows the former List 3 uses to continue until Board action and 

rulemaking are complete. If the NOP adopts a policy by December 31, 2015, that covers 

former List 3 as well as other inerts – which is my hope – then that pol-, then that policy 

will prevail. So that hopefully by the time we actually get around to reviewing these, we 

will have a policy that we can bring back to you, the Board, and we can review 

everything at that time. But this, this really establishes this as a priority and indicates that 

given the history of Board policy on this, it is, we really cannot afford to move this in a 

five-year timeframe – that we really need to move this more quickly. 

So, here is how this translates into the actual language to the listing. List six, 205.601, 

synthetic substances allowed for use in organic crop production. So we strike out the 

word inert and add the other words in italicized here. As syn-, I will read the new 

language - as synthetic, other ingredients, not classified by the EPA as active ingredients 

for use with non-synthetic 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 substance. I am sorry. It is... That is... Let me read it again so that you can see it. 

Any synthetic other ingredients not classified by EPA as active ingredients for use with

non-synthetic substances or synthetic substances used in this section and used as an 

active ingredient in accordance with any limitations on the use of such substances. That is 

the existing language. We are just changing a few words there. 

Then, we are adding this language. Inert ingredients exempt from the requirement of 

tolerance under 40 CFR 180.one 1122 that were formerly on EPA list 3 in passive 

polymeric dispenser products may be used until December 31, 2015, after which point 

they are subject to individual review under 601, unless already covered by a policy 

adopted by the NOP for all other inert ingredients.

Comment [JMS12]: 03:00:00
Meeting Of The National Organic Standards Board

May 23, 2012

45

And then the Committee backup is obviously the existing language, the existing listing. 

So you can see it does not have the cross-throughs and all that. 

And then we define passive polymeric dispenser products, which has not been really 

defined. And this is the definition: Solid matrix dispensers delivering pheromones 

through volatilization only at rates less than or equal to 150 grams active ingredient –

active ingredient, AI – acre per year that is placed by hand in the field and is of such size 

and construction that it is readily recognized and retrievable – and this cites other Federal 

Register notices – to be removed as a definition when 601(m)2(a) and (b) expire. So in 

other words, we will not need this once we get to a generalized policy. This will be 

obsolete at that point. 

So, this was our vote. We have a unanimous vote on this out of the Committee. 

Just to give you a sense of the public comments. We received a lot of support from --

well, we received support from everybody for that, the actual language change. I think 

there are differences of opinion on the history and interpretation of the history. And, you 

know, what I have given you are quotes from the Board. So, you can take that, you know, 

as you will. 

But, what we have are some individuals call for the elimination of List 3: Beyond 

Pesticides, CFS, NOC, Food and Water, Cornucopia are disappointed that former List 3 

inerts have not yet been individually reviewed. The same organizations call for review of 

inerts formerly on Lists 4a and 4b. 

And then, OMRI emphasizes the importance of having the appropriate plan for inert 

ingredients to pher-, in pheromone dispensers, and CCOF expresses a similar concern. 

WDA strongly disagrees with the Committee's conclusions about the duty of the NOSB

to do individual reviews. OTA and CCOF view the recommendations as an acceptable 

interim measure while a comprehensive inerts policy is being developed. 

That is the presentation. And, if any other members of the Committee would like to add 

to that or amend it or provide additional information, I would be happy to have you do 

that. And, if not, we can take any questions that you guys may have. I know this is 

sometimes a complicated subject. Yes? 

Mac Stone: Looking at paragraph 2 of the recommendation, last line. Unless covered by policy 

adopted by the NOP for all other inert ingredients, shouldn't it just be for all inert 

ingredients? Because otherwise, it would... 

Jay Feldman: Yeah.

Mac Stone: To include these. And I am reading that right?

Jay Feldman: Yeah. Let me see. Yeah, I guess we could remove. So, you are talking about the 

passive pheromone dispenser? 
Meeting Of The National Organic Standards Board

May 23, 2012

46

Mac Stone: Just take the word "other" out, because otherwise then, to include "these". 

Zea Sonnabend: [Inaudible] It means the same thing either way. It is a little bit more cleaner the

way Mac says it, but it means other, these – the ones we are talking about in this 

paragraph – as well as others. 

Mac Stone: [Inaudible]

Jay Feldman: Okay. Any... Yeah, that is helpful. We can amend that. Any other questions or 

comments on this? Yes? 

Harold Austin: Jay, have we gotten any further clarification from WSDA on that fourth potential 

ingredient? 

Jay Feldman: Not that I know of. Do you know of anything? 

Zea Sonnabend: The Inerts Working Group does know the identity of that. It was disclosed in the 

course of tabulating all the different inerts. So, Emily has that information. But, it is not

released to the public, yet, and some procedure would need to be made to notify because, 

the Inerts Task Force knows the identity of the inert, but not what product it occurs in. 

So, a procedure would have to be made to solicit a petition on that one in order to review 

it. 

Jay Feldman: Go ahead. 

Harold Austin: Next question. Would this, more I think to the Program, would us passing this 

one, would it have any impact on the potential work of the Inerts Working Group and 

what you are looking to propose in the future? 

Miles McEvoy: Yeah. We have a number of comments on this particular proposal, and one of 

those is about the Inerts Working Group. That the NOSB set up the, with the NOP, the 

Inerts Working Group to provide a proposal on Inerts – List 3 Inerts, List 4 inerts –

because of the EPA getting rid of the List 3 and List 4 inerts. This is a very important 

issue that needs to be done through a comprehensive approach. So, the Inerts Working 

Group was formed to develop a proposal and come back to the Board with that particular 

proposal for the Board to then review. And so, this particular proposal is outside of that 

process that was established by the Board. And so, we are concerned that that would 

potentially conflict with the recommendation or the proposal that comes from the Inerts 

Working Group because this would set a precedent in terms of how we would be 

approaching inerts and it might conflict with the comprehensive approach that the Inerts 

Working Group, working with EPA and NOP, is working on developing. So, we see it as 

outside of the process that you already established, where you set up this Inerts Working 

Group to make recommendations back to your Board. So, it is outside of that process. 

Jay Feldman: [Deep breath] Would you like my interpretation of this, Harold? 
Meeting Of The National Organic Standards Board

May 23, 2012

47

Well, first of all, this is Sunsetting, so the Board has to make a determination. It would be 

very problematic, I believe, for the Board to issue a five-year re-authorization of this, relisting of this, given the history that I read to you and the history of this Board and its 

intent to review these List 3 inerts independently, and independent of whatever happens 

on List 4. I mean, if we are talking about dozens and dozens, you know, obviously that 

would be a different issue. 

And, the other belief, given that, given the pace of the work of the Working Group, is 

that, you know, the expectation is it will be done and so we can come back to the Board 

with a comprehensive policy but that this has to be highest priority, given the nature of 

some of these reviews that are needed. And, that leaving it for five years would be 

inappropriate, given the history on this. I mean, the question of whether it is a precedent 

is really, you know, I respect that opinion. But, you know, this is List 3 and it has always 

been a distinct listing in this, in our rule from List 4. It has been treated distinctly. It has 

been reviewed distinctly. And so we have to, unfortunately, we have to make a decision 

on that, because of the expiration.

Mile McEvoy: Yeah, just to clarify on this particular listing. It was not part of the original, the 

final rule that was published in 2002, or was effective in 2002. That is why it is 

Sunsetting in 2013. It was added to the National List in 2003, so over a year after the 

final rule went into effect. And the reason for that is that it was thought that with passive 

pheromone dispensers, there is no application to the crop, so therefore, the inerts that 

were being used in these passive pheromone dispensers were kind of irrelevant. And 

therefore, were being used in organic agriculture, were being allowed by the Program and 

by certifiers and by the industry. And then, that was added as an afterthought in 2003. 

And that is why it is Sunsetting in 2013, rather than in 2012. So it really was not part of 

that original review that the NOSB did on, with the original recommendation that you 

referred to earlier. It was not under consideration. That recommendation was really about 

the List 4 inerts that are in active pesticide products that are actually applied to the crops.

So there is a very, there is a distinction here on the passive pheromone dispensers. 

Jay Feldman: Yeah, but to clarify, the Board has specifically taken up List 3 many times. And, 

you know, we talk about following policy. The Board has been very clear that it wanted 

to review these independently, as an independent specific... 

Zea Sonnabend: I have a comment and a question for the Department. A clarification on the List 

3’s is that, just because something was on the old List 3 did not mean it was necessarily 

bad or toxic. It is just that the EPA had not classified it to one of the other lists yet, 

because enough studies had not been done. The fact that in their new exemption from 

tolerance schematic, they moved all the pheromone dispensers into their own section, 

with other semiochemicals, which is the 40 CFR 181.1122, implies that they have 

completed whatever studies they are planning to do, and that they have deemed those 

particular inerts to be not of concern – similar to the 4a Inerts, for the reasons that Miles

stated. 
Meeting Of The National Organic Standards Board

May 23, 2012

48

My question, which is based on what Emily was saying, is: if the inerts policy is going to 

be put forward soon, but the rulemaking on the policy will not be completed until 2017,

does that mean that the review of the individual inerts would not start until 2017? Or 

would be completed in 2017? Because that is a huge difference. 

Emily Brown-Rosen: Well, we are not anticipating changing the current list, the current listing 

for List 4 until Sunset of... and that has to be changed by 2017. With... the process has to 

start three or more years before that in order to do that. But, it depends how that change 

happens. I mean and how much, what, you know, what it says.

Zea Sonnabend: So, if a policy is passed, yes, we want to review individual inerts, or even 

groups of inerts, but any review that we do, that review can start well before 2017, so that 

we can take List 4 off of the list in 2017? 

Emily Brown-Rosen: I will let Melissa talk about this, because, you know, we could do separate 

rulemaking, you know, and have a whole separate thing going on there. But, let me let 

Melissa talk about that. 

Melissa Baily: Yeah. I think what we would look for is to start that process many years before 

the 2017 deadline so that we could address it all in one streamlined regulatory action for 

list 4 inerts. So, I think that was the original discussion that the Program had with the 

Board when we talked about setting up the Inerts Working Group was that we would 

come up with some sort of policy and that that policy, if it does contain individual review 

of inerts, that we would address those all in one rulemaking for the Sunset 2017 for List 

4. Does that answer your question? So in terms of timing, because this would be a change 

from current practice, I would certainly advocate for the more time that we can have to 

get the rulemaking done on this, the better. So, I would advocate that the Board start any 

kind of review quite early.

Zea Sonnabend: Right, well that is exactly why we thought, we will start with these three, or 

maybe four, inerts and pheromone dispensers and try and complete that by 2015. So at 

least that can be done. And by then, we will have, be well underway on the overall policy 

with the overall other inerts. Because, three, compared to 121, you know, if we cannot do 

three by 2015, there is, like, we are not going to meet a 2017 deadline on the rest of them. 

Do you see what I mean?

Jay Feldman: Are there other questions? Okay. Go for it.

Zea Sonnabend: If, since we know that the Department doesn't like this 2015 date, but, since we 

feel that past, as Jay said, you know, past attempts to move inerts review forward have 

languished or failed in the five-year time period, is there any way that the date could be 

taken out, but, in the strongest possible of terms or language in the recommendation, it 

insists on moving the review of inerts forward?

Melissa Bailey: Is that a question for us? 

Comment [JMS13]: 03:15:00
Meeting Of The National Organic Standards Board

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49

Zea Sonnabend: Yes, I was asking the Department. 

Melissa Bailey: So, you would be, to clarify, what you would be suggesting would be to remove 

just the date from the annotation you are proposing, and, but retained the reference to 

some sort of outside NOP policy that may be adopted? 

Zea Sonnabend: Yes, possibly. I think I would like to retain the language about 40 CFR

181.1122, because I think that the EPA wants us to stop saying List 3, List 4, like that. So 

if it is in the regulation, I feel that reference should be maintained. And, I feel that the 

will of the Board, the past Boards, certainly, has really been to move this forward 

seriously. But, we do not want to make the Department mad at us, but we do definitely 

want to use the strongest possible efforts to move this forward. 

Jay Feldman: Can the Program respond, or does the Program want to respond to it? 

Emily Brown-Rosen: I would just like to say. I mean, I would have, well, what language are you 

proposing? I mean, maybe, if you... You are saying just take the date off and, and say

exempt from requirements of tolerance under 181.1122, that were former List 3 may be 

used until 2017, or until next Sunset? Is that what you are saying? Or just end it there? 

And then, and then you could make a separate recommendation that is not a National List

recommendation and recommend that the Program do, you know, something else that you

want us to do? But, I mean if you, it is very hard for us to put in the National List an 

annotation that says, unless already covered by a policy adopted by the NOP. That... we 

cannot put that in the rule. You have to, you have to put the proposal up to there and stop. 

And you could make that as a separate recommendation. But that is not something that 

can go. You know something that goes in the register has, it is the rule, until you change 

it. So that would be the rule. It would not be something voided by another action. We 

would have to then make another rule to change it. So we cannot say this is the rule until 

we tell you something else. It does not work that way. 

Mile McEvoy: Yeah, just to clarify, we cannot allow things that the Board has not approved. So, 

we cannot allow inert substances in passive pheromone dispensers unless the Board has 

recommended to do that. We cannot do that by policy. There is something that we can, 

but this is one area where we cannot. So, that part is definitely a problem. 

Jay Feldman: That was intended to show the spirit of the committee's work, in terms of trying to 

coordinate with the List 4, but given the Sunset date that we have, the need to move 

forward on this and really make it clear that this is a priority, given the years of inaction 

on this matter. And by the way, just so that the Board members know, there is a high 

degree of frustration at EPA that we have not gotten our act together on this. 

Zea Sonnabend: So, perhaps, would not it make more sense, in light of Emily's report, to put a 

date of October 2017 in it, so that it is at least in sync with the rest of the inerts and the 

rest of the proposed re-change of the inerts policy? 

Miles McEvoy: We missed that, sorry.
Meeting Of The National Organic Standards Board

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50

Emily Brown-Rosen: Sorry.

Zea Sonnabend: Wouldn't it make more sense, in terms of what Emily presented, that instead of 

an automatic five-year renewal, we put a date of October 2017, which would be one year 

sooner than it would have Sunset normally, so that it is in sync with the rest of the inerts 

Sunset? 

Miles McEvoy: You are making us, you are making us think a lot here. I think, okay, a couple of 

things. One is that, that Jay said that the EPA is frustrated. I think there might one person 

that has made some comments of that, but that certainly is not an official, official position 

from EPA that they are frustrated with us. So I think that needs to be clarified that there 

has been no communication from EPA that they are frustrated with the National Organic 

Program or have any problem with the National Organic Program's listing of List 3 and 

List 4. We are working together to solve this problem. And we have a very good working 

relationship and we will solve this problem. 

Okay, so the other point was the 2017 versus 2018. That seems like that is a little, that 

gives us a little more flexibility. We could potentially work with that more easily than the 

2015. We are just really, really concerned about the expiration dates, because it causes us 

a lot of extra work, and that means that we are not getting other work done. We know this 

is an important issue. Another concept would be to get the, to have a recommendation to 

get the correct annotation with the 40 CFR 180.1122, and then as a separate 

recommendation, say that the Board wants these List 3 inerts individually reviewed and 

evaluated by 2017. So, you take two separate actions. You direct the, well, your 

recommendation to the Program is, make this happen. And, that might be a way to split 

those two different issues, to make sure that we are accountable, to make sure that 

happens.

Jay Feldman: Would that be an annotation change? Make this happen? 

Miles McEvoy: No, it would not be, it would not go into the rulemaking process. That would be 

separate from the rulemaking process. 

Jay Feldman: Miles, I just, you know, we have had side conversations on this and, just so the 

Board knows, what is happening here is so detrimental to organic, in my view. This is an 

issue that could be easily resolved, should not have taken the Working Group two years 

to get to a conclusion. We should have been prepared at this Board meeting to present an 

overall policy, in my view. That did not happen. 

We are in this situation we are in. We have to show the public we are moving forward, 

not with a make this happen resolution, but with a clear, extremely clear set of guidelines 

and actions that we can point to. And I can point to my constituents and say, the NOSB is 

serious about this. This has got to be resolved. We have too many other issues that have 

been hanging out there, and many people were told this was going to be resolved two 

years ago. We thought we would have resolved this by now.
Meeting Of The National Organic Standards Board

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51

I know we did not have specific deadlines in stone, and that is part of what is driving this 

approach with the deadline. Because when we do not get those numbers and dates in 

stone, other priorities do overtake us. I understand that frustration. But, I really want, you 

know, the Board to understand, at least in my view, that I cannot support delaying this 

beyond what is necessary to get the job done. And we can get this job. We could have 

gotten it done for this Board meaning, quite frankly. 

This proposal was in deference to the work of the Working Group. It was in deference to 

the Program to not rush things with a deliberative process. And, and for me, and for the 

people that I am sitting here representing, even what we are proposing here is too long 

and has been, unfortunately, allowed to go on, after all of these Board votes. So we make 

a big deal around here of honoring previous Boards and the decisions they have made. 

And this is one where it is so clear. And I would like to honor what the previous Boards 

have said on this, and I respect what they have, their deliberations. And I would like, I do

not think this is too much to ask. And, I know we can get it done and it will get us in a 

position where we can point to resolving a nagging issue that we, that we are... I know 

the Crops Committee is committed to working on. So thank you. 

Any others? Go ahead. 

Melissa Bailey: Just one other point. Or, I guess a question for you, Jay. How critical is the 

definition that you are proposing to this, to moving this recommendation forward? The 

addition of passive definition for...? 

Zea Sonnabend: We look at it as fairly important until the individual materials are reviewed. 

Because, there are new pheromone technologies out there that groups such as OMRI and 

other mat- MROs have not been able to determine whether that technology is actually 

passive pheromone dispenser, as in the old language. And so, by adding the word 

polymeric, and defining passive, you know that passive polymeric is part of a thing, is 

fairly important to the MROs, if this language continues because the 40 CFR 181.-22 is 

much broader interpretation of semiochemicals rather, outside of passive polymeric 

pheromone dispensers. 

Melissa Bailey: Okay. Thanks for that, that information. Just for your consideration, I guess, we 

have, to my knowledge, and somebody can correct me if I am wrong, we have never 

added a definition during a Sunset rulemaking. So, I am not sure what that would mean 

in, mean in terms of our process, and generally, the scrutiny that we come under trying to 

get these things out the door. So, I just wanted to make you aware that this is something 

new, unless somebody has other examples that we have not done before. 

Zea Sonnabend: The definition language, however, is cited in another CFR section that we put in 

the definition there. And so, it is not like we made up the definition. We took, just took it 

from a different federal regulation.
Meeting Of The National Organic Standards Board

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52

Melissa Bailey: Sure, yep, yeah, I understand that. I am saying that if we are adding it to the 

NOP regulations, you are adding it to terms defined? 205.2? That we, that we have not 

done that kind of exercise, and generally Sunset has been about the materials and not 

adding new things to the regulations outside of the scope of the substances being 

reviewed under Sunset. 

Zea Sonnabend: Can it be done through guidance instead of in the rule? 

Melissa Bailey: Potentially. 

Nick Maravell: Could it be done in the text of the amendment, just as a reference to another 

federal definition? We already have the reference to 40 CFR 180.1122, and then we could 

add the reference after passive polymetric [polymeric] dispenser products, and just put in 

the citation to the CFR. 

Unknown Male: Yeah.

Melissa Bailey: Yeah, I mean, I guess my answer would also again be potentially. What I am 

trying to do is explain to the Board, you know, we are in the middle of the Sunset 2012 

rulemaking where we had a number of annotation changes that has really taken a lot of 

heavy lifting to get those out the door. And so my expectation would be, again, if we are, 

the more we are doing in Sunset on some of these substances, the more it is going to take

for us to figure out how to actually execute them. And I do not know exactly what that 

looks like until we get it kind of in the queue and in the process. 

Jay Feldman: That sounds like a good suggestion, since it is a CFR cite, and we have in, I 

believe, in other annotations, cited CFRs or other... So, it would not, it would not...

Emily Brown-Rosen: Jay, I think we have to check on that. I think that was a proposed rule but, 

from EPA, I do not think it is a CFR. It is just a Federal Register. So I am not sure if it is 

an official cite. 

Jay Feldman: Okay. 

Nick Maravell: Emily, are you saying that that is not a final rule? That citation? 

Emily Brown-Rosen: I do not believe so, yeah. 

Nick Maravell: Okay, well, then that is a problem. 

Jay Feldman: Okay, we will, we will regroup and see if we can cite a, if there is a citation that is 

in the CFR. Yeah.

But, but otherwise, this, you are saying an edit, or amendment to 205.2 under definitions 

is a separate process or cannot be done in coordination with this process? Or would be a, 

Comment [JMS14]: 03:30:00
Meeting Of The National Organic Standards Board

May 23, 2012

53

would it create an additional burden that you are saying would, might delay the process 

or something? 

Melissa Bailey: Correct. Yeah, we, again, anything that we have not done before takes a lot of 

explaining on our part to get it out the door. And so I just want the Board with sort of 

clear eyes to understand that we have not done this before, so in terms of the rulemaking, 

I do not know what that ends up looking like. And, just want you to be aware of that

potential unknown. 

Jay Feldman: Okay. You know, just so the Board understands, we were trying to create clarity

for the product manufacturers because this has not been defined. We were trying to 

provide some closure on this issue so that people were not asking questions about what 

we were talking about when we said poly, these passive polymetric [polymeric]

dispensers. We could take that out and just leave the manufacturers in continuing limbo, 

and let folks figure it out for themselves. Harold, you may have something to say about 

this? I do not know whether you feel a definition is necessary, or you are happy with the 

way things are. 

Harold Austin: Jay, I think a definition probably should be in there because all of these inerts 

really pertain to that specific process that is being used by the, the you know, the

growers. I mean, so, I think, you know, these are not individual inerts that are used for 

separate, separate issues. They are all being used for one, one pointed application. So, I 

think having that definition in there, I think there is value to that. But, I would defer to 

the rest of the Board's thoughts as well. 

Jay Feldman: Any other comments or questions or thoughts? Anybody? Board? Program? John?

John Foster: Thanks. As we were talking about the other night, Jay, in the Crops meeting, I guess 

I am not convinced yet, that the net benefit of a shortened timeline outweighs the, the

potential problems. I am just not, not convinced, yet, that, that in total it is that way. And 

I would be interested to hear other Board members’ thoughts on that because we have 

talked about it in committee and I would like a wider discussion, if we could have, on 

that. Because that really is a, it is an important feature of this, and there is a lot riding on 

it, I think, for industry, there's a lot riding on it from perception, and a number of angles. 

And my, I will just wrap it up with that invitation. But, my experience, when we have put 

accelerated expiration dates on things, my recollection is there is, that has caused a lot of 

problem in the past. And I am not looking forward to doing more of that unless it is just 

absolutely necessary. And I do not know if that kind of measurement has been met yet. 

So I would be interested in other, other Board members’ thoughts on that. 

Nick Maravell: John, have you heard specifically from the industry on this deadline issue on 

inerts? 

John Foster: Yeah, anecdotally. I mean, like, I hear from a lot of, you know, community 

members on a lot of things. Just that particularly in the Northwest, I have a fair number of 

contacts there, and their... I do not think it is a well-organized, you know, set of 
Meeting Of The National Organic Standards Board

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54

comments. But, the hope is to have as many tools as available as possible, especially on 

an essential tool for, and this is just Pacific Northwest, so I do not know as much about 

other production areas on these crops. But, it is, it is a critical tool, and to mess with a 

critical tool in anyone's toolbox is, that is, that is kind of threatening. So, that has been 

mostly the message is worry over a, an accelerated timeline, and the system's ability to 

actually process, to actually process what we do pass in a timely fashion, and, then also, 

concern over the ability of any one inert ingredient to get the okay that they would feel it 

needs particularly under, under that accelerated timeline. There's concern about that, also. 

Nick Maravell: Jay, have you heard public comment with regard to the timeline issue here? Are 

we at risk of producers not having the tools that they would need to continue production? 

Jay Feldman: Well, as you know, this does not take anything off the market. This creates, this 

subjects these materials to review, that is all. There is always a possibility when you 

review something that it gets annotated or removed, of course. But that is not what this is 

about. This is about bringing ourselves into review in accordance with what we are 

supposed to, what at least the Crops Committee, felt we are supposed to do and the 

previous Board, as I stated. 

You know, I was pleased to see that the community came together around this, John. I, 

you know, I... We are always going to have different interpretations of intent and spirit 

and all that. But, it was great to see that people realize that even if they did not like this a 

little bit, that this was one of those issues that we, we as a community, had to come 

together on. And everybody did support. And to answer your question, Nick, the 

comments we got came through the Federal Register and they were all supportive of this 

language.

Whether people did that reluctantly, not with a lot of enthusiasm, I am not characterizing 

it. But, I am saying that people recognize that we have to put this behind us. We have got 

to get this, our house in order on these issues of inerts and, and we put them, we run them 

through the National List process. And then we move on. But, I have not heard anything, 

in terms of economic impact associated with the review process. I have heard, clearly, we 

all have heard, that pheromones are an essential tool in organic crop production or at least 

sectors of crop production. We have heard that many times and we have already 

discussed that as a Board. So we understand that part of it. This is a separate issue of 

whether we are going to move these inerts through the review process. 

Okay, sorry. 

Mac Stone: Just from listening, I would suggest that with the long history of the conversation 

here, and the lack of uniformity between the position of the Program and the Board on 

this recommendation, 2017 is still a hard, fast number. But, it gives everybody more time

to align with the other inerts proposal, or policy. But it still is a hard, fast deadline, versus 

forcing the hand of a system that has not communicated real well, apparently. 

Jay Feldman: Go ahead, Miles.
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55

Miles McEvoy: Yeah, that would be good. Can I add a couple of other ...

Jay Feldman: Yes, go ahead. 

Miles McEvoy: ... points? Yeah, I first want the Board to recognize that there is current 

standards on inerts, that the restrictions on inerts under the USDA organic regulations are 

part of the reasons why the USDA organic regulations are the, the highest standards in 

the world. No other organic standards, well, Canada has some restrictions on inerts, but 

the, the major organic markets, the EU, for instance, there are no restrictions on inert 

ingredients in approved, allowable organic pesticides. So the current standard is, part of 

the reason why the USDA organic regulations are very strict, and why, to a large extent, 

the USDA organic standard is the gold standard around the world. So I just want to make 

sure that people understand that, that this is a much more thorough review process than 

what is going on in other organic standards. 

And the other point is that this, the approach of reviewing each inert ingredient, that that 

would set a precedent, or potentially set a precedent for the List 4 inerts, and we just do 

not have the resources, the financial resources to do the technical reports, or you do not

have the time to do all the reviews for those 200 materials that are currently on List 4. So, 

you really have to think this through of how, how this particular proposal interfaces with 

those other 200 materials for inerts that are not even contacting the crop. It just seems 

like the, the inerts that are contacting the crops should be a higher priority from my 

perspective.

Unknown Male: [Inaudible]

Zea Sonnabend: Okay, I just, to respond to one thing that you say frequently, Miles, that, the, in 

Europe, they do not review inerts. The reality is that in Europe, their EPA-equivalent 

does not allow quite so many inerts as we do. And so what goes into products in Europe 

even though they may not review inerts, they are working with a much narrower group of 

things that they can put into those products. And so I just do not think that argument 

means all that much, in terms of our reality here in the US, where the EPA has put, you 

know, 900 or so ingredients that can be used for inerts, many of which would not be 

allowed in Europe.

Jay Feldman: The other thing I was, I am not sure I heard you correctly, but, these are, these are

substances that come into direct contact with food, that, you know, this is not... Did I 

miss-hear you on that? I mean, these are, these are ingredients in products that we allow. 

And, we are trying to figure out a way given, and it is really, the motivation for this is 

hopefully you, you all recognize, and the recent inerts get separated out from the other 

ingredients that we look at, is because they are proprietary information. So when 

someone comes to us and says, I want to register, I want you to allow a particular 

substance, and they are, they are basically, we are allowing a product, per se. That

product is a formulation that has a lot of different ingredients. Many of which we are not 
Meeting Of The National Organic Standards Board

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56

privy to, because they are considered proprietary business information, confidential 

business information.

So, we, we have always had to deal with inerts in a separate track. We... That is why 

EPA deals with them separately, too. So, but, that does not mean they are not in products 

that we allow that are applied directly to crops, that are... Did, were you saying something 

different than that? I did not, I missed that, I guess.

Miles McEvoy: With passive pheromone, ...

Jay Feldman: Oh, I see.

Miles McEvoy: ... passive pheromone products, those are not being applied to the crop. They are 

being put into the ...

Jay Feldman: Right.

Miles McEvoy: ... the orchard or the field, and those pheromones passively are dispensed. And, 

but they are not applied. They are not ...

Jay Feldman: Right.

Miles McEvoy: ... put in a spray tank and applied directly to ...

Jay Feldman: Right.

Miles McEvoy: ... the crop. So that is the distinction. [Inaudible]

Jay Feldman: Well. Okay. Obviously, it is a material. It is something that is subject to our 

review. I mean, that is, you are getting into the substance of whether we would allow it or 

not, which is not... You know, the presumption here is that pheromones are important 

materials. We are having a discussion on whether we, as a Board, have a responsibility to 

review those materials. You know? And to....

Miles McEvoy: Yeah. No argument there. But what I am just saying is that in terms of the, the

application of the substance, those other inert or other ingredients in pesticide 

formulations that are directly applied – which are the List 4 inert substances – are things 

that are directly applied to the crop, versus the List 3 inerts – that are allowed in passive 

pheromone dispensers – are not directly applied to the crop. To me, it is a higher bar or a 

higher priority to look at things that are directly applied to the crop, than things that are 

not directly applied to the crop. That is the only point I am trying to make there. 

And then in terms of, Zea, what you were saying about the EU review. The EU review is 

done member state by member state. And there are, there are substances that are allowed 

within those various member state reviews that are, go beyond the, the List 4 other 

ingredients, inert ingredients that are allowed. So there is no review process in terms of 

Comment [JMS15]: 03:45:00
Meeting Of The National Organic Standards Board

May 23, 2012

57

their organic system. There are substances that are further restricted in the US system that 

are allowed under, in the EU system. 

Jay Feldman: Again, Miles, I think why it is really hard to ask the NOSB to put aside a 

responsibility, based on a presumption that the use pattern is not of importance, vis-a-vis 

our, our checklist, our review in accordance with all the things we do as a Board, as a 

Crops Committee, as whatever committee we are on. We are, we are looking at food. We 

are looking at environment. We are looking at all kinds of issues related to the use of 

products. And, you know, we, again, we are not saying anything different here than has 

been said by previous Boards. We have just got to get, we have got to get moving on this. 

And, we will just have to decide whether that it seems like the timeframe is reasonable or 

not. But, that is what it is coming down to, it seems like. Thanks. 

John Foster: So, I do not know if, I do not know if it was just a lot of thoughts in, in everyone's 

heads, but you were referring to these for a second it while ago as ingredients. And I 

think it might have just gotten caught up, because ...

Jay Feldman: Substances...

John Foster: I heard, I heard you say ingredients a few times. I think it was probably just 

momentum. But anyway, I wanted to call attention to that. But...

Jay Feldman: Well, they are ingredients in pesticide products so, you know, pheromones are a 

pesticide registered by EPA, it is a, I mean I guess technically, it is an, it is an ingredient 

in the product. So that is...

John Foster: Right. In the context of the sentence structure you were using, that was not 

necessarily clear, though, because we were talking about food also. So, enough about 

that. 

But the other thing is, I do not, I do not get at all that the Program is asking us to set aside 

anything. I do not, I do not feel that that is the way. I do not feel pressure that way. I have 

not heard anything along those lines. So, I do not, I do not approach it that way. And I, I 

feel like this has been a very good collaborative process, on this issue particularly. And 

so, I wanted to get that out there, too. I do not, I do not feel like I have been asked to put 

aside anything. That is it. 

Jay Feldman: But, five years, in my, I, I was saying that in reference to five years. Because to 

me, that just is, does not seem reasonable, given what the history is on this. It is a 

contextual. 

John Foster: Right. Yeah.

Jay Feldman: Yeah.
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58

Harold Austin: Jay, I rep-, for the stakeholders and stuff that I represent, I think the additional 

time to get some consolidation of the inerts I think probably makes better sense. I also 

think that by giving that extension that the Program has suggested, that if there was a 

problem with one of the three inerts or possibly four inerts that are in the, the dispensers, 

then it would give the stakeholders, that I sit here and represent, the opportunity to find 

alternative measures if needed because we cannot ensure that all of these are going to get 

passed. 

Jay Feldman: Right.

Harold Austin: So I think that two year, I think you are still living up to the previous Boards’

intent. I think also you can go back to the stakeholders that you are representing and 

giving them a definitive that there is a timeframe that has now been established that has 

not been in the past. And I think we can all do that. And I think it is a collaborative effort 

here that I think we can move this process forward and I think we can all take and come 

to a mutual agreement. But, I do not think what the Program is, is asking us to do – by 

extending it by two years and getting everything consolidated – I do not think that is an 

irrational approach at all. So I, you know, my, I agree with John. I think that moving it to 

two years down the road is not the end of the world. Actually, I think it, there is, it solves 

a lot of other issues that potentially could arise from that decision, if we move this 

forward as it sits right now. 

Jay Feldman: Thank you. 

Zea Sonnabend: I agree with Harold, and as such, I think I will, if this is called for a vote right 

now, I will vote against this and recommend that the Crops Committee [sigh] meet before 

Friday to [laugh] separate this in... Well, either that or I can propose language and we can 

put it off until Friday, to separate this into two separate motions. One would be the 

motion that exists now for the 40 CFR 180.-122, in- with a date, instead of December 

31st a date of October 2017, and then a second motion urging review of these specific 

inerts sooner than that, if at all feasible, in the strongest language but not being a National 

List motion, that we could talk about in the Crops Committee further to develop that.

Tracy has a question.

Jay Feldman: Yeah. Tracy.

Tracy Favre: Miles, I have a quick question for you. If, if we do adjust the deadline language to 

2017, I, I just need to get some clarification. It seems to me, as big of a concern is the 

potential setting a precedent for review of the individual materials. Can you give me 

some feedback on that? 

Miles McEvoy: Yeah. We had those concerns about the individual, our capacity, the Board’s 

capacity to review all individual inert or other ingredients in pesticide formulations. So,

we have already invested, the Board has invested a lot of time and resources into the 

Inerts Working Group. Jay, yes, they have not reported back with a proposal but they, 
Meeting Of The National Organic Standards Board

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59

they have reported back on a lot of information and they have a couple of things that they 

are mulling over to come back to the Board. The Board, the previous Board invested into 

that, the Program has invested into that Inerts Working Group. So, the main point is that 

we would suggest waiting for that group to come back with a comprehensive proposal 

around all inert ingredients, including the List 3 and List 4. So this particular discussion 

about going to 2017 to line up the List 3 and List 4 together, that seems, that does seem 

more feasible. But, we still have those concerns about the capacity, both of the Board,

your time and energy, and the Program, in terms of resources for technical reports of 

individually reviewing all, all of these substances on an individual basis. On the other 

hand, you know, maybe this is a trial run, that you could see what it is like. And, if it is,

becomes completely unworkable, then we get creative and find another way to, to move 

down the road.

Jay Feldman: We should... You know what? Can.. . We can pick this up because we should take 

the public comments. I feel bad that we missed them. I apologize to the public

commenter who is hopefully still here. I realize I overlooked asking Jonathan Ashe, if he 

is still here, to make his presentation.

Michelle Arsenault: Actually, Jay, he rescheduled, and it should be Sarah Wintzel-Fisher. 

Jay Feldman: Oh, okay. Well, at least you have the benefit of hearing what all of the issues are. 

So...

Sarah Wintzel-Fisher: Hi, I am Sarah Wintzel-Fisher. I am a small scale agricultural producer 

and I also manage Growers Markets here in the city. I live here in Albuquerque, just a 

few blocks away. I am a member of the Cornucopia Institute and I am here today as a 

citizen lobbyist.

The Cornucopia Institute supports the Crops Committee’s proposal to review List 3 

inerts. These chemicals should never have been listed without the proper review that is 

[background noise] required by the Organic Foods Products Act. And NOSB should 

move forward with the review. As outlined in the proposal, List 3 inerts should have been 

reviewed by January 1st 2002. Previous Boards have repeatedly stated that these inerts 

need to be individually reviewed. Given that there are only four List 3 inerts that require 

review and that the Crops Committee had no other work on its agenda for this meeting, it 

is inexplicable why the Crops Committee again delayed the required review of these 

materials. 

Consumers expect organic food to be produced without the use of potentially dangerous 

chemicals, and they especially expect any synthetics used in organics to have been 

thoroughly reviewed and approved. This expectation is legally grounded in OFPA. These 

chemicals should not be given a free pass from the legally required review process simply

because they have been given, they have been referred to as inerts. 

The terms “inerts” is misleading, and even the EPA encourages manufacturers to use the 

term other ingredients instead of inerts. Inerts cannot be considered benign or harmless, 
Meeting Of The National Organic Standards Board

May 23, 2012

60

especially since they often act to increase the effectiveness of the active ingredients. Inert 

ingredients can have toxic, toxicological effects on human health or the environment. We 

believe that all inert ingredients, including those formerly categorized as List 4a and List 

4b by the EPA should be reviewed. 

While it may seem a daunting task given the number of chemicals on the list, it is

absolutely necessary for the integrity of organics that all chemicals used in organic 

production be reviewed. Organic consumers expect nothing less. If strategies exist to 

facilitate and expedite the review of these chemicals, such as grouping certain chemicals 

in classes and reviewing classes, rather than individual chemicals, we would support any 

strategy recommended by Beyond Pesticides, which is a leader in the field of protecting 

human health and the environment from toxic effects of agri-chemicals. Thanks for 

listening. 

Jay Feldman: Thank you, are there any questions? Okay. 

Calvin Walker: You are suggesting, with the large list of inerts, the possibility of grouping them 

by certain classification to speed up the process? 

Sarah Wintzel-Fisher: Yes, I think that that would be helpful. 

Jay Feldman: Thank you. Oh, is there another question? Sorry, go ahead.

Harold Austin: Are you a farmer or a grower as well? 

Sarah Wintzel-Fisher: Yes. 

Harold Austin: Just a quick question. Are any of the crops that you deal with here locally, do 

they use maybe disruption or the pheromone dispensers on those crops? 

Sarah Wintzel-Fisher: We do not at our farm, and I am not sure about other farms. 

Harold Austin: Okay, thank you.

Jay Feldman: Go ahead. Do you have a question? No. Thank you very much. 

Sarah Wintzel-Fisher: Thank you. 

Jay Feldman: Okay, so this actually is the time period in which we designated discussion and 

modification proposal. Do people feel ready to vote on this? I mean, you had suggested, 

maybe, Zea, that we needed time to reconstruct something or construct something, but 

how are other people feeling? So, Zea, if we were to vote now, would you be able to 

propose an amendment to this? Or how would you want to proceed? 

Zea Sonnabend: I feel that, in light of what the Department said, it needs to be divided into two 

motions to separate out the timeline issue from the individual review of the inerts issue. 
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61

Because, putting the individual review into the same motion is not really a National List

Sunset subject at the moment. You know? According to what they say. So, I would like 

to have one line, one thing for the first part of the motion, with a deadline of October 

2017. And then the second motion [sigh], you know, urging them to move forward with 

individual review as quickly as possible. And, I do not think I can quite get a good 

wording on the spot. I am wondering if anyone else agrees with me, but... 

Harold Austin: Jay, I... is it possible to take like a five or a ten minute recess? Which may 

actually end up saving us time here, and to, to confer on this briefly? Would that, would 

that be a good idea from your point of view, Zea? 

Zea Sonnabend: Yes, perhaps if maybe the Crops Committee could get together in that recess 

and talk about revising...

Nick Maravell: Mr. Chair, Barry, can... we would request that you call a 15 minute break and 

then we could reconvene for 15 minutes to vote? 

Barry Flamm: I have a couple of thoughts there. One, we have a gentleman that wants to, needs 

to catch a airplane. He has a, a comments that he would like to make, but it is on 

Livestock. I wonder if we could take that and then break for lunch. And that would give 

you extra, extra time to get your committee together.

Jay Feldman: Enough time to ruin our lunch?

Crowd: [Laughter]

Barry Flamm: Ruin your lunch.

Zea Sonnabend: And eat into the Livestock time after lunch so we can discuss the new proposal?

Barry Flamm: No, no. 

Jay Feldman: No, no. We come back. 

Barry Flamm: We will come back.

Jay Feldman: Oh, yeah. Would... Yeah, would we come back early? Is that what you are

suggesting?

Barry Flamm: Yeah, come back early. And then you, and then you proceed with the voting. Just 

taking the lunch now, rather than taking it later, except, giving this gentleman a chance to 

make his three-minute comment. Is that okay with you, Jay? 

Jay Feldman: Yes.

Barry Flamm: Is that alright? If we... Alright. John Bruinquett. Is that correct?

Comment [JMS16]: 04:00:00
Meeting Of The National Organic Standards Board

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62

John Brunnquell: It is close. 

Barry Flamm: Close, huh?

John Brunnquell: No, thank you. I appreciate the courtesy extended. I have to jump onto an 

airplane a little bit. I am John Brunnquell. I am president of Egg Innovations. Wanted to 

address some issues to the Livestock Committee. In response to several years of NOSB

topics as they related to the organic egg industry, we wanted to share with you that our 

industry has begun to coalesce under the Organic Egg Farmers of America. And you will 

see several of those people out here today. I am coming to you also is a director of that 

group and as their secretary. 

We, we presented to you through written comments our, our feelings on the methionine 

issues and we, we urge you to take a look at those. We want to share with you that, as a 

membership base, we currently represent about 10% of all organic egg certificate holders 

in the nation, but about 60% of all organic egg production in the United States. 

The thing we wanted to chat a little bit about today was the vaccine issue and GM, GMOs 

and their use of that. As of July 7th this year, all flocks over 3000 birds in the United 

States, including organic birds, are going to be obligated to follow an SE prevention 

program. As part of that SE prevention program, it is strongly recommended by the FDA

that vaccination for SE will be part of that program. 

And so, that is our real world, where we come here, we agree in spirit about removing 

GMOs from organic. But, we have real practical issues where the next meeting we all 

attend, proverbially, is with an FDA person who is saying, tell us your SE prevention 

program, we really do not care that you are organic. We have food safety issues, and 

where that vaccination program is a little unique is that we are not vaccinating as 

specifically for a disease for the bird although as he is, we are really trying to do a

preventative food safety issue, that we cannot wait and react to after it occurs to come 

back and deal with the source issue. 

And so we share with you that these are issues that are out there. We support in concept 

the removal of GMOs from organic, but we ask you to move very patiently as it is the 

discussion of GMOs and vaccines in organic egg production. Thank you. 

Mick Maravell: I do not know who is calling for questions.

Barry Flamm: I am going to let Wendy do it since it is her committee.

Wendy Fulwider: Nick.

Nick Maravell: Thank you for your comments. I have several questions, and I am glad you are

here and we were able to get you before you had to leave. Are there a variety of SE, this 

is salmo-, salmonella and then...
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63

John Brunnquell: enteritidis. 

Nick Maravell: ...enteritidis. Are there a variety of vaccines available or are there only one or 

two? 

John Brunnquell: The latter. There is, there is a very small bucket. There is I want to say two or 

three manufacturers, and there is about two or three choices of what you can use. 

Nick Maravell: And do you, currently now, have any knowledge as to whether or not those 

vaccines might be impacted by our proposed, what was our proposal? 

John Brunnquell: I do not have specific knowledge. I have a general awareness of how vaccines 

are developed. I wouldn't be surprised that they would be in conflict. 

Nick Maravell: Okay. Because I, I do have some anecdotal information that goes both ways on 

that. Okay. So, so you are saying it is, it is open for discussion as to what, what your 

options really would be, to satisfy both an FDA program and an NOP type program. 

John Brunnquell: Well, what we are saying is, we are going to vaccinate with whatever is 

commercially available with SE. We do not present ourselves as an expert on does that 

currently use GMOs, or are there non-GMO forms available. We are subject to, there is

two or three choices. That is all we have to use independent of the organic discussion.

Nick Maravell: Right. And, if you were to try to find out that information, where, what would 

you do now? What are your options for finding out? 

John Brunnquell: We would approach our technical service people that support our various 

companies. 

Nick Maravell: And, and do you think that they have adequate guidance now to make that 

determination for you? 

John Brunnquell: I could not speak to that without talking to them. 

Nick Maravell: Alright. [Inaudible] So, would you say that most of your producers are going to 

fall under the FDA guidance of flocks of 3000? Or when I say your producers of, of the 

group that is forming the Organic Egg Producers, do you feel that most of them would 

fall under the FDA guidance rule of flocks of over 3000?

John Brunnquell: Currently, we have approximately 60 members, of which approximately 55 of 

them would be over 3000 birds.

Nick Maravell: Okay. Thank you. Are there any other?

Barry Flamm: Thank you.
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64

Wendy Fulwider: Joe has a question. 

Barry Flamm: Oh, Joe.

Joe Dickson: You said that the, the FDA, I think the language you used was strongly suggests the 

use of the virus, or the vaccine rather, but it stops sort of short of saying requires. Can 

you give a little more color to the extent to which that advice is being given out? 

John Brunnquell: Certainly. We are, all flocks over 3000 birds beginning July 7th this year – all 

flocks over 50,000 are already subject to that rule – have to have some type of salmonella 

enteritidis prevention program. The FDA outlines several key characteristics of strong 

recommendations. They include harborage, which is preventing mice and rodents, cooler 

temperatures, and keeping eggs cool. And so there is a series of best practices. And of 

that, the vaccination with salmonella, you know, preventative vaccines is a strong 

recommendation. The other thing we have to bring visibility to, although we are not 

proud of it, the last egg recall of the United States was an organic farm. So, while we, we

want to say, everything is great in the organic world, statistically, the last egg recall in the 

nation was organic. The vaccines are very effective. FDA does not mandate, at this point, 

that it is the law you use them. But, they do mandate that you have an SE prevention 

program. And best practice of science is that you would use that tool.

Wendy Fulwider: Mac.

Mac Stone: John, we met at the poultry meeting in Minneapolis. But, part of that is keep them 

indoors, right? Or, access to outdoors is part of this formula, if you will. 

John Brunnquell: There is, the, that is an area obviously of a lot of debate. The FDA and the 

organic community, quite frankly, are going to have to figure that out beginning October 

of this year. October of this year is when we have been informed on-farm audits will 

begin. And, in our discussions with Jerry Ramirez who was there, it was very clear they 

do not have that figured all out, yet. They understand that organic says you must be 

outside. And they equally understand that that is not their issue. Their issue is prevention 

of salmonella. And so, there is not a clear path, at this point. 

Wendy Fulwider: Nick.

Nick Maravell: What have you been able to determine in your management programs of, have 

been the most effective in preventing salmonella? In other words, there are, the FDA

guidance has got a variety of things. You know, give us an idea of the types of things that 

you are currently doing, and how a vaccination program fits into that and your overall 

priority on vaccinations.

John Brunnquell: Sure. And, and I would encourage you, as other people during the course of the 

day speak to the Livestock Committee, they might have slightly different variations from 

ours. We start with baby chicks that are purchased from clean hatcheries. In our pullet
Meeting Of The National Organic Standards Board

May 23, 2012

65

facilities, we monitor the fly levels. We monitor the rodent levels, and we swab the 

facilities during the lifetime of they are in the pullet facility to ensure that they are SE

negative. In our world, we also vaccinate for SE twice during their pullet life. When we 

get to the layer level, again, we follow a very comprehensive program where we are 

monitoring on a weekly basis fly counts, rodent counts. We have people that audit the 

facilities as far as is the lawn mowed, are cooler temperatures maintained? So it is a very 

comprehensive approach which I think nears probably a lot of our colleagues in the 

industry. Vaccines, in of themselves, are not the answer. They fit in an overall program. 

Would we be extremely nervous without them? Yes. 

Nick Maravell: At what ages are you vaccinating and do you vaccinate once you, or do you also 

have to vaccinate once they reach maturity?

John Brunnquell: We vaccinate twice: once in the window of time between 6 and 10 weeks old, 

and once in the window of time between 12 and 16 weeks old. There are two different 

types of vaccine so that you can provide a broad protection level for the bird.

Nick Maravell: So, there is no, no vaccination once they reach maturity?

John Brunnquell: Once they are in the layer barn, there is no supplemental vaccination. 

Wendy Fulwider: Thank you. 

John Brunnquell: Thank you all for your time. 

Barry Flamm: We will now recess for lunch and be back here at 1:15.

[BREAK] 

Barry Flamm: ... back in session. Jay, would you continue with the Crops business? And...

Jay Feldman: Thank you, Barry. Welcome back, everybody. Hope you had a good lunch. I have 

asked Michelle to put up language that we discussed over lunch. And I will give you the 

background on this. 

The Crops Committee met over lunch and discussed, continued the conversation and tried 

to reach resolution on moving forward. And so, I think what we have is, is really a threepart proposal. And again, I am going to ask for clarification on this and concurrence. So, 

I, I am not meaning to have a perfect report at this point. But, I just want to make sure 

that we discuss these three elements. And that is the issue of the Sunset of List 3 and how 

that will be handled; the issue of defining passive polymetric [polymeric] dispensers and 

how that will be handled; and then, a motion adopted by the Board that would ensure that 

we, as expeditiously as possible, move forward with an inerts plan and incorporate those 

activities into the work plan of the Crops Committee. So that we might address the issue 

of inerts well before the deadline that is in the current Sunset for List 4 inerts. The goal in 

all of this being to get to a point where we can bring everything in sync, you know, have 

Comment [JMS17]: 04:12:30

Comment [JMS18]: 05:26:25
Meeting Of The National Organic Standards Board

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66

List 3 and List 4 reviewed as, as one, one group of materials and prioritize, based on 

hazard or concern or whatever the prioritization system is. But, not slow down the 

process of review, and not delay this sense of urgency that many of us have, or at least 

sense of concern that we have, that we are not moving forward at the pace that we could 

be or ought to be. 

So, the, the proposal, then... Let me see if I can get this up here. I will read it into the 

record. Is, Barry, is that sufficient in terms of having a written document? Or do you need 

anything more than that? I am going to read it now. Okay. So, starting at the beginning. 

List 205.601, Synthetic Substances Allowed For Use in Organic Crop Production. (m) As 

synthetic other ingredients, not classified by EPA as active ingredients for use with nonsynthetic substances, or synthetic substances listed in this section, listed as an active 

pesticide ingredient in accordance with any limitations on the use of such substances. (2) 

Inert ingredients exempt from the requirement or tolerances under 40 CFR 180.1122, that 

were formerly on EPA List 3 of passive polymeric dispenser products may be used until 

December, I am sorry, October 31st, 2017. Twenty-first. Oh, 21st? Yeah. Good. 2017. 

And then, that period and that would be the end of that part of the motion.

Barry Flamm: Okay, would, Jay, would you restate that in the form of a motion? What will be 

precisely voted on? 

Jay Feldman: Okay. The committee moves to... I am going to have a three-part motion because I 

think these all have to work together. 

Barry Flamm: Do you want a separate vote on each one? 

Jay Feldman: No, I... what I would like to do is put the motions out there and have discussion. I 

guess that we could discuss them separately. But, I would like, since we had, did this on 

the fly over lunch, what I would like to do is present them, have the discussion, and then 

go back and have individual. Because we may need to amend, amend the language, if that 

is okay. 

Barry Flamm: It would be better if you just would state the motion and we vote on each one of 

them as we proceed. 

Jay Feldman: Yeah. Okay, I... Then at this point, then, I would like to start with the, with the last 

part of this effort to reach consensus. And that is with the broader motion on our overall 

intent. And then I'll work backwards to this, if that is okay with you. And the intent being

that, and I will just read what I have drafted so far. Motion: It is our understanding, or is 

the understanding of the NOSB, that the NOP is committed to expediting the review of 

all inert ingredients as soon as possible and will support the NOSB in creating a plan for 

inerts review and an accompanying work plan for the Crops Committee to complete this

work. 

Barry Flamm: Is there a second? 

Comment [JMS19]: 05:30:00
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67

Unknown Male: Second.

Barry Flamm: The motion has been moved and seconded. I will not try to repeat without, I do 

not have that in front of me. Discussion? 

Unknown Female: Could you repeat it?

Jay Feldman: It is the understanding of the NOSB that the NOP is committed to expediting the 

review of all inert ingredients as soon as possible and will support the NOSB in creating a 

plan for inerts review and work plan, accompanying work plan for the Crops Committee 

to complete its work.

Barry Flamm: Okay. And you have that in writing on your...

Jay Feldman: Yeah.

Barry Flamm: ... computer? Alright. Do we have any comments from the Board? Okay, Zea? 

Zea Sonnabend: Okay, I guess, Jay, because we are taking this one motion at a time did not fully 

explain the reasoning behind this in the context of us extending the deadline. Because, we 

acknowledged, as a committee, that extending the deadline was a good idea and that in 

the overall inerts proposal that we hope to have before the Board at the fall meeting, there 

may or may not be an individual review of these particular List 3 inerts at the beginning 

of the process. And, because they are really further down the list in the scale of inerts of

concern. And so that we will put them in the timeline somewhere, or categorize them 

somewhere when they come in in the full proposal in the fall. But, we did not necessarily, 

and the Department especially, did not think it should be locked into individual review of 

those three inerts sooner than the rest of the inerts proposal. So, in the context of that, the 

people concerned about inerts review among us, which is most of us, of course, said we 

can extend the deadline, but we want to only extend the deadline if we get a real 

commitment. If we let the Department know that we really have a commitment to get this 

done and we want them to facilitate that as best as possible. So, that is where this is 

coming from. 

Barry Flamm: Thank you for that ...

Jay Feldman: Thank you. 

Barry Flamm: ... excellent explanation. 

Jay Feldman: Very good. 

Barry Flamm: Are there any...
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Jay Feldman: Can... May we ask the Department to just express its concurrence with this? I 

mean, I, I hope this reflects the agreement, or the sense, anyway, of our discussion. 

Miles McEvoy: Okay, you said a lot of things and there is a lot of different proposals here. But, 

what we concur with is moving forward with the petitions that have been received for the, 

the List 3 inerts.

Melissa Bailey: [Inaudible]

Miles McEvoy: Okay, I am going to turn it over to Melissa since I am not paying attention here. 

Melissa Bailey: Okay, so I think what we, our understanding, if I could restate it back, is that the, 

the Program agrees to support the, the Inerts Working Group process to move forward on 

inerts review. That may, depending on what kind of proposal the Working Group comes 

out with, the individual, any individual review of List 3 inerts may not actually occur 

first. It could occur later on in the process because of prioritizing inerts in however those 

may be reviewed, according to the Working Group for List 4. So, that we certainly 

support and would provide the, the resources and support to get there. That is my 

understanding. Emily, did, do you want to, is that your understanding? Is that, Jay, is that 

satisfactory? Or... Were you listening? [Laughing] 

Jay Feldman: Yeah, I mean, clearly, the intent here is that we, we are not, it is not our preference, 

I should say, to delay this beyond what is necessary. And so, we do not want to just wait, 

as we typically do in a Sunset review process, for the date to approach, and then begin the 

development of a proposal, so as to meet a deadline at the end date. We want, we would 

like to see a process that begins as expeditiously as possible, and begins a process of 

review, hopefully, in, in hopes of, of resolving these issues well in advance of the, of the

deadline. 

Barry Flamm: Okay, thank you, Jay. 

Mile McEvoy: Yeah. Just to clarify, we definitely can commit that, that this is important and we 

will move that forward. In context of all of the other things that we are moving forward 

as well. So, is a lot on our work plan, a lot on your work plan, you know what is 

important, we will move it forward.

Jay Feldman: Thank you. I really appreciate that. 

Barry Flamm: [Inaudible]

Jay Feldman: So, moving back then, Mr. Chairman, to the first motion. 

Barry Flamm: No...

Jay Feldman: Or, the second motion now. Sorry. 
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69

Barry Flamm: No, Jay. 

Jay Feldman: Oh, we need to vote.

Barry Flamm: No, we have got to complete the discussion if there is any more comment. 

Jay Feldman: Oh, sorry.

Barry Flamm: Since there is no more discussion or questions from the Board, we will begin the 

voting with Tracy. 

Tracy Favre: Yes. 

The Entire NOSB Board : Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. Yes. Yes. Yes. Yes. Yes. Yes. 

Barry Flamm: And the chair votes yes, and I am sorry, I should have asked the conflict of 

interest question. Does anybody have a conflict of interest? And that would require 

withdrawing your vote. Hearing none, there is no indication there is a conflict of interest. 

So, the vote stands. It is 15 to zero. 15 yes, zero no. Proceed, Jay.

Jay Feldman: Okay, so the second motion is an amendment to what you received in your Board 

packet. Again, I will read it as I read it earlier. List 206.601. This is, this will be 

committee recommendation to adopt, as 205.601. Synthetic substances allowed for use in 

organic crop production, and as synthetic inert, other ingredients not classified by the 

Environmental Protection Agency, EPA, as active ingredients for use with non-synthetic 

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. (2) Inert 

ingredients exempt from the requirement of a tolerance under 40 CFR 180.1122 that were 

formerly on List 3 in passive polymeric dispenser products may be used until Dece... 

October 21, 2017. 

Zea Sonnabend: I second that.

Barry Flamm: Jay, we seem to have something different on the screen than what you...

Jay Feldman: Really?

Barry Flamm: ... you read. Is it? Or maybe I cannot see. 

Miles McEvoy: That is it.

Barry Flamm: Was it okay? Okay. 

Unknown Male: You cannot see the cross-out. 

Miles McEvoy: Yeah, you cannot see the [inaudible].
Meeting Of The National Organic Standards Board

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70

Jay Feldman: It is hard to see the cross-outs. 

Barry Flamm: Okay, that, that was your motion? Or you want to restate...

Jay Feldman: Yes, sir.

Barry Flamm: ... re-read it and form a motion? 

Jay Feldman: Oh, I am sorry. I move that... Do I have to re-read the whole thing? 

Crowd: [Laughing] 

Zea Sonnabend: I second it.

Barry Flamm: I will ask later. Is there a second? 

Zea Sonnabend: Yes. 

Barry Flamm: Zea seconds. Discussion, and if anybody wants a clarification of what the motion 

is, Jay can provide that. Any questions, discussion from the Board? Hearing none, we 

will proceed with the, with the vote, beginning with Carmella.

Carmella Beck: Yes. 

The Entire NOSB Board : Yes. Yes. Yes. Yes. Yes, sir. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes.

Barry Flamm: Again, I do not know if this required a request of, of any conflict of interest. 

Please state it. If not, ... Oh, Zea? 

Zea Sonnabend: I put out pheromone twist ties on my apple orchard just last week, and by using 

them, I will get more apples and more money from selling the apples. Is that a conflict of 

interest?

Crowd: [Laughing] 

Barry Flamm: There is ...

Miles McEvoy: Well, that is a disclosure of your interest. It is not a conflict that you would need 

to recuse yourself. 

Zea Sonnabend: Thank you.

Barry Flamm: Okay, the vote stands, 15 yes, zero no. 

Melissa Bailey: Barry? 
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71

Miles McEvoy: Barry?

Melissa Bailey: Excuse me, Barry? Did you actually say yes to the vote? Did you actually cast 

your vote?

Barry Flamm: Oh, I didn't. I say yes. Thank you.

Melissa Bailey: [Laughing] 

Jay Feldman: And because of our process, I move, I move the committee recommendation for a 

backup vote to relist, which is list 205.601, synthetic substances allowed for use in 

organic crop production, (m) as synthetic inert ingredients as classified by the 

Environmental Protection Agency, EPA, for use with non-synthetic substances or 

synthetic substances listed in the, listed in this section and used as an active pesticide 

ingredient in accordance with any limitations on the use of such substances, and (2) EPA

List 3 inerts of unknown toxicity for use only in passive pheromone dispensers. I move 

that.

Barry Flamm: Okay. Second?

Harold Austin: I will second. 

Barry Flamm: Harold seconds. Sort of redundant, but any conflict of interest on this? 

Zea Sonnabend: Same disclosure as last vote. 

Barry Flamm: Okay, I think the decision would be the same. Any discussion on this backup 

vote? Do you, any new member have any question on what the backup vote is for? Okay, 

hearing none... Oh, you have got a question? 

Unknown Male: Just a comment. I know it is really hard for Jay to make that motion. [Laughing] 

Jay Feldman: Thanks for feeling my pain.

Barry Flamm: Okay, hearing no more requests for discussion, I think John, you are up to begin 

the voting. 

John Foster: Yes. 

The Entire NOSB Board : Yes. Yes. Yes. Yes, sir. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. 

Barry Flamm: And the chair votes yes. 

Jay Feldman: And then, I move the Committee motion to add a definition to 205.2, terms 

defined. Passive polymeric dispenser products, solid matrix dispensers delivering 

Comment [JMS20]: 05:45:00
Meeting Of The National Organic Standards Board

May 23, 2012

72

pheromones through volatilization only at rates less than or equal to 150 grams active 

ingredient, AI, acre per year, that is placed by hand in the field and is of both size and 

construction that is readily recognized and retrievable. 50 FR 7368, March 30, 1994. 

Unknown Male: Do we still need to [inaudible]

Zea Sonnabend: I second. 

Jay Feldman: Well, I, I guess we need to still include, to be removed, as a definition when 

205.601(m)2(a) and (b) expire.

Zea Sonnabend: Okay. 

Barry Flamm: Is there a second to the...? 

Zea Sonnabend: Yes, I second it. 

Barry Flamm: Okay, we have a motion on the floor which has been seconded. Is here any 

discussion? Yes, John? 

John Foster: Can I ask about the, the necessity of the applied by hand portion? Is that, and I do 

not know, maybe Harold, you can, you have a better sense of how important that part is. 

But, and exactly, I mean, I hate to do this, but what, what do we mean by that? I can

imagine, for example, using a tool to put something in place of one's hand, you know, to 

not necessarily twist it on with your fingers, but with something else. I do not know. 

My...

Unknown Male: A robot?

Jay Feldman: The, the majority of the, of the growers use application tools to physically put the 

pheromones up to the tree or to the trellis wires. They, they do not use their hands. There 

is a tool involved. 

Zea Sonnabend: But, you are still doing it by hand because you are using a tool. It is not a 

machine that goes into the rows and does it.

Unknown Speakers: [Inaudible] Yeah, that is true. In the row. Yeah.

John Foster: I apologize for that question. 

Crowd: [Laughter]

John Foster: But, I mean, it sounds silly to ask: what do we mean by applied by hand. But 

actually, I can imagine a world where someone would want, you know, could have issue 

with that. If we mean it is put on with a tool, then maybe that is not... If we do not want 

to be that specific, that is all I am saying. 
Meeting Of The National Organic Standards Board

May 23, 2012

73

Zea Sonnabend: We copied... The definition was copied out of a Federal Register definition, 

elsewhere. And they said by hand. So, that is what we are saying.

Jay Feldman: Any other? Carol, do you have a problem with that wording? 

Barry Flamm: Any other questions, discussion? If not, we will proceed with the voting. With 

the... Joe is next. 

Joe Dickson: Yes. 

The Entire NOSB Board : Yes. Yes. Yes, sir. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. 

Barry Flamm: 15 yeses and zero noes, and myself. I always forget myself. The chair votes yes, 

and that makes it 15 yes, zero no. Thank you. That completes the Crops session. Next up 

is a Livestock Subcommittee with Wendy Fulwider, as chairperson. 

Wendy Fulwider: Thank you, Barry, and Michelle has some slides that we are going to bring up.

And I just want to let everybody know that we are going to take things slightly out of 

order because we have people that want to give public comment, and they have planes to 

catch. So we are going to take one kind of in the middle of our presentation. 

I will start here while the slides are coming up. But, our agenda today, I am going to start 

out with animal welfare guidance, and the, the pieces that I am going to talk about are:

why do we need animal welfare guidance? Who is generating the pieces for each species, 

and how will they be used? And after that, we will take off with the GMO vaccine 

discussion, and Nick Maravell and Jean Richardson will lead to that. 

So, why do we need animal welfare guidance? First, we need it for consumers. 

Consumers expect good animal welfare, and they want assurance that the food producing 

animals are treated well. The majority of consumers do not have access to farms or no 

farmers at this point, with so many suburban folks. Less than 1% of our population is 

engaged in farming in this country. And, many consumers are not aware of the fact that 

there are animal welfare requirements within OFPA. One more. Okay. 

Certifiers, inspectors, certified operations and animal care: When the NOSB passed the 

animal welfare recommendation, it was with the understanding that we would have 

strong outcome-based measures that would be a part of this Program. This is to be a tool 

for use by certifiers when they need it. It is not for use on every farm, or for every 

certification. It offers different ways to assess the compliance with the animal welfare

recommendations. 

The species-specific guidance pieces should be helpful for producers, because this should 

help them avoid doing multiple animal care audits by different certification agencies. It 

should all be covered within the organic certification. It is, will also be helpful to farmers 

that are transitioning to organic. I go out and do animal care checks with our Organic 
Meeting Of The National Organic Standards Board

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74

Valley producers, and I use similar scorecards and tally sheets to what I have proposed 

here for use by the organic community. And, it is, it is very helpful when you are talking 

with a new producer that is new to organic, and they are not accustomed to the, the

different ways that we manage, because it is different than when they were conventional. 

It is also helpful to producers that are expanding or renovating, you know, their facilities. 

Because they are going to do something different than they did when they were a 

conventional operation. It should also be helpful to farmers that are having issues, 

whether it is with hygiene or body condition or, or locomotion. Because, that is all part of 

management and management issues should be a part of the guidance pieces. 

Who wrote the guidance drafts? The bison piece was written by Dave Carter, who is a 

former Board member. The poultry section was started by Holly Born when she was at 

MOSA and Sarah Shields, who is an HSUS consultant, and studied with Temple Grandin 

and Barry, Berty Rollin at Colorado State, did the academic portion of the poultry piece. 

The sheep guidance was written by Bonnie Wideman from MOSA, and we have, as a 

Board have already, or as the Livestock Subcommittee, have already started making 

refinements to that piece. The dairy outcome scores and tally sheet were written by me, 

and it is very similar to similar, very similar to score sheets that I have used in the past

and the one that is also used at Organic Valley. So, I think with these pieces, you know, 

they are, they need a lot of refinement, and we need to do a lot of editing before they are 

ready to go. But, I think we are off to a really good start. 

This is an example of the piece that we have prepared for the guidance. And, this piece 

shows the loco, locomotion scoring. And these are standard industry scores, the same 

with the body condition scoring, all standard industry pieces and similar to what the 

National Milk Program is using when they go out and do voluntary audits. There is the 

hock lesion. This piece has the hock lesions and the cow hygiene, and also similar to 

what is used in the National Milk Program Federation audit. 

So, this would help you to determine if animals are thin on a farm, if they are not clean 

enough, how many lame animals are they, how lame are they? Is it actually issue? It is

normal to have animals on a farm that are challenged. You know, if you have animals, 

they are going to find ways to get in trouble. They get sick. They get dirty. They get hurt. 

And so, it is just a tool to deter, determine whether or not there is an issue. So, the 

scorecards can be helped, can be used to help make decisions when you are out on a 

farm. And, the guidance pieces can also be used to educate and inform, whether it is

consumers or producers or anyone else that is involved in, in checking welfare. So.

Future guidance will be developed for beef and swine and Tracy Favre has volunteered to 

do the beef piece. And I have two ladies working on the swine guidance, Marlene 

Halverson, a farm animal welfare consultant at Farm Forward and producer at Field 

Productions LLC. Tracy Harper is a reproductive swine physiologist and agribusiness and 

science technology instructor at Western Technical College in La Crosse, Wisconsin. 

And they are both familiar and have worked with organic hog producers. 
Meeting Of The National Organic Standards Board

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75

Written public comments, we have received 626 pages in pdf form. So, we have not been 

able to go through all of them. Previously, Calvin has sorted and analyzed all of them for 

us, so that we can sift through and use part of it and make decisions on, on our 

refinements. 

And so, I just want to let everybody know, if you are not going to be here for our, our

closing, at the fall meeting, this is the list of things that we are going to be addressing, 

and of course, the things at the top of the list will be addressed first. 

And with that, if there are a few questions, on the species-specific guidance, animal 

welfare pieces, I would like to take those from the Board and then we will move on to the 

GMO vaccines. 

Okay. So, Jean, I believe that you are up next. 

Jean Richardson: Okay, well the Livestock Committee worked for several months on the coming 

to this meeting with the recommendation that GMO vaccines should be used only during 

an emergency or they can be petitioned as individual substances. However, we received a 

considerable amount of public comment, suggesting that we needed more information 

and providing additional information, indeed, and also we got further information from 

the NOP staff themselves. So, it made it obvious that we would need to table this 

recommendation for this meeting. 

However, what we are hoping that will happen today is that all of your expertise here will 

clearly help us and inform us with factual information and data that can allow us to come 

back to hopefully the spring meeting with a better recommendation or a clear 

recommendation, or perhaps it will be the same one. I mean I really do not know. 

Obviously, I am not going to second-guess the experts. 

So, what my goal here just briefly, as briefly as I can with a complex subject, is to try to 

outline how we got to where we are right now. And then after I have spoken, Nick is 

going to look at some of the questions that have been raised during our work, and also 

from those that came in from public comment. 

So, basically, the NOSB is seeking to clarify if in fact GMO vaccines as a class of 

substances is allowed or prohibited under requirements stipulated in 205.105(e) and 

205.600(a). At the moment, livestock producers use all vaccines, as they are allowed to 

do, under the, under the standards including 205.603(a)4. But, the National, the NOP has 

received advice from General Counsel that GMO vaccines should only be allowed if 

specifically added to the National List. GMO vaccines are not on the National List. 

Obviously, vaccines are used nationwide in most farms, not all. There are closed herds 

and there are small farms that do not use vaccines on a routine, routine basis. We know 

from experience, our boots on the ground, that typically, producers do not go and ask 

their veterinarian or the producer or where ever they buy the vaccines from, if they are 

GMO or non-GMO at the present time. Producers... Let us see what else. 

Comment [JMS21]: 06:00:00
Meeting Of The National Organic Standards Board

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76

Since its implementation in 2002, certifiers have routine been allow, routinely been 

allowing all vaccines. So that in 2009, the NOSB recommended that if non-GMO

vaccines were not commercially available, then a GMO vaccine could be allowed

because that was the practice of the time. So the status quo essentially was officially left 

in place. Nonetheless, what is very important is that all consumers out there are still 

assuming that all organic products, both in the processing and in the handling, are in fact 

non-GMO. And we have already had the Zea's vote on that yesterday, as I recall, that 

non-GMO is still as popular as ever. 

So if we look at the relevant areas of the rule, if you look at 205.238(a)6, it states that 

livestock health care practice standard requires that producers must establish and 

maintain preventive livestock healthcare practices, including the administration of 

vaccines and other veterinary biologics. And then if you look at 205.603(a)4, in 2002, the 

NOP simply lists without annotation, synthetic substances allowed in livestock 

production, they allow biologics, vaccines, without annotation. Then, if you look at

205.105(e), the allowed and prohibited substances in organic production and handling, 

the product must be produced and handled without the use of excluded methods, except 

vaccines, provided – and this proviso is very important – provided that the vaccines are 

approved, according to 205.600(a). And, the relevant section of 205.600(a) requires, sets 

up evaluation criteria for allowed and prohibited substances requiring that we look at a 

whole group of criteria use, that the NOSB has to look at the whole range of criteria as 

specified in the, in the Act. And the reference is provided there. 

Now, obviously, the NOSB has not reviewed GMO vaccines under 205.600. That has not 

happened. We have received a technical report, as you know, and we have used that as 

we began to go through the rule and look at the reality of what was happening out in the 

country. We also looked at the, the history of, of what the NOSB has previously done. In 

2009, the NOSB added the phrase in their recommendations for excluded methods except 

vaccines, provided that vaccines made from non-excluded methods are used, if 

commercially available. And it was at this time that they essentially accepted status quo. 

They said at the 2009 meeting, the rationale of the Livestock Committee at that time, it 

says: Previously, vaccines made by excluded methods were to be individually petitioned 

to the Board, for allowance or prohibit, prohibition of use. In reality, since – still quoting

– in reality since implementation of the rule, certifiers have routinely allowed all 

vaccines, since they are used to prevent disease and needless suffering of animals. This 

recommendation will more closely align with what has been occurring in the field since 

2002, however, it will actually make it incumbent upon the producers and certifiers that 

vaccines made by non-excluded methods are located and used before those made by 

excluded methods. End of quote from 2009. 

The NOP responded to this in 2010, and let me read from, from their document, which 

includes reference to the, to the final rule as well. The Act allows use of animal vaccines 

in organic livestock production. Given the general prohibition on the use of excluded 

methods, however, we believe that animal vaccines produced using excluded methods 

should not be allowed without an explicit consideration of such materials by the NOSB, 
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77

and without an affirmative determination from the NOSB that they meet the criteria for 

inclusion on the National List. It is for this reason that we have not granted this request of 

commenters, but rather, provided an opportunity for a review of a narrow range of 

materials produced using excluded methods through the National List process. 

So, the NOP's understanding is that excluded methods are prohibited under section 

205.105(e), except for vaccines. And further, that this exception applies to vaccines that 

are produced only if the GMO vaccines are approved according to 205.600(a), again. So 

we still have that to keep in mind. The NOP requested a legal review from USDA’s 

Counsel of, Office of General Counsel, the OGC, to determine whether vaccines 

produced through excluded methods are currently allowed under 205.603(a)4. The OGC

opinion supports the position that GMO vaccines are allowed only if they are approved 

according to 205.600(a). 

So, there we are. So, what do we have in, to work with, then, at the present time? The 

Livestock Subcommittee looked at a wide range of questions and attempted to get 

answers, both from the technical report by having people on phone calls from, from 

industry, from, from labs, producers of vaccines, to try to answer some of the questions 

that we posed. I am not going to go through those in detail right now. But, I will say the 

one thing that we, we were able to determine is that there is, in fact, a list: it is the APHIS

list.

The Animal and Plant Health Inspection Service’s APHIS List maintains a periodically

updated list of all registered vaccines with code alpha-numeric annotations that could 

allow a certifier to determine if a vaccine being used is GMO or non-GMO. However, I 

should tell you, having looked at this list, it is certainly not easy to really be sure what it 

is you are looking at. Especially because the, the products on the list are typically listed 

by generic names and, and, and the code is not clearly able to be used.

And furthermore, what is important is what we have found is that obviously, most of the 

producers using vaccines are actually using combination vaccines. They are not just 

giving one at a time, they are using a group of six. So maybe one of those is GMO, one 

is, and all of the rest are not. We did get some information that allowed us to believe that 

it would be possible to have all of, basically all vaccines available in a, in a non-GMO

format. And I am hoping that as we get into the discussion section that we will get some 

clarity on that. 

So, if I just synthesize the findings. Section 205.238 requires producers to maintain 

preventive healthcare practices, including the use of vaccines. You cannot deny treatment 

to an animal in order to re-, maintain organic status. That is not permitted under the rule. 

Livestock vaccines are commonly used. The list is not easy to understand, and at the 

moment, there is no requirement that a producer be asked to tell their inspector or the 

certifier whether they are using GMO or non-GMO vaccines. 

I should add also that Canada does not allow GMO vaccines, as far as I am aware, or we 

are aware. Europe does allow GMO vaccines, with the typical exception, as we presently 
Meeting Of The National Organic Standards Board

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78

are using. An interesting sidebar in the World Health Organization and the Food and 

Agricultural Organization in Europe differentiates between GMOs in, in food, and GMO

vaccines, saying that with engineered foods, the intention is to introduce a new trait into a 

food, and this trait is present in the food eaten by the consumer. On the other hand, 

genetically modified vaccines are used to, to provide a provective, protective immune 

response by means of an mmune, immunogen that is often no longer itself present at the 

time the animal is slaughtered. 

So we have a large amount of data and information with which to continue to proceed on 

this. So, public comment makes it clear that we need further information from all of you 

here today. And, and we are particularly concerned, of course, with the poultry industry 

issue, and the need for a greater understanding overall. 

So, that is my general, sort of, introduction and I will turn it over to Nick at this point.

Nick Maravell: Wendy, do you want to [inaudible]

Wendy Fulwider: Yes, we would like Don Blake to come up and give public comment before 

Nick begins his presentation. 

Don Blake: Is this where you need me? Okay, hello. I am Don Blake. I am the Director of 

National Accounts with Newport Laboratories. I work primarily with the production 

systems of the large food companies in the US and all of Latin America. 

The comments that I want to make: Newport is the largest producer and manufacturer of 

autogenous vaccines in the US. And, we are also, we have the largest diagnostic lab, 

private lab, in the United States as well. And it basically supports our vaccine business. 

What autogenous vaccines are, very straightforward, we get isolates in from the farm 

level. These would be primarily viruses and bacterias. We produce a vaccine. We can do 

combinations of viruses and bacterials. And, these vaccines are constructed under our 

USDA license, the protocols that we have registered with the USDA. But, unlike a 

commercially produced and licensed vaccine, our protocols are very broad.

And unlike commercial products, we can fully disclose to the customer, the veterinarian, 

a lot of information about the antigen that is in there, the adjuvant that is used, 

preservatives. Basically, you can direct the product. It is your vaccine. You can 

customize it. And that is what the large food companies really look to me and to our 

company to do. Food safety is what they are all about. So they want to control their

inputs. They want to know everything that goes into it and they want to understand that.

So, on the GMO issue, we do not produce vaccines that way. We certainly can, we have 

the technology to do it. We can do it if we are asked to, but the autogenous is an 

alternative. Again, anything that we find on a farm, we can make a vaccine out of. And, it 

doesn't have to be done under GMO standards. 
Meeting Of The National Organic Standards Board

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79

Recently, we were purchased, March 28th, by Merial. They are one of the world largest 

animal health companies. They bought us specifically for our autogenous production.

Merial is a, has... Merial Select is the largest poultry vaccine company in the world. So, I 

heard from the Board that this is an area of concern. 

So if you look at our capacities, I mentioned we are the largest. In 2011, we produced 

approximately 86 million doses of vaccines. That is about 63% of our internal capacity. 

We can expand our capacity very rapidly. With being owned by Merial domestically, 

Merial has three large animal health vaccine plants in Georgia. We can contract actual 

antigens to have them made there, if we need added capacity. We can finish them off in 

Worthington, where we are located. So, we, capacity I do not see as ever really being an 

issue in the arena that we play in. We are primarily pigs and cattle. But, we can also --

okay, I am done. Questions? 

Nick Maravell: Yes, could you please continue? [Laughing]

Don Blake: Okay. Well, I am pretty much wrapped up from what I said. 

Nick Maravell: Okay.

Don Blake: Timelines, though, I will be real quick on the timeline. When we get an organism in, 

if it is a bacterial, it takes us 4 to 5 weeks to make a vaccine on the first time. Viruses are 

about 6 to 8 weeks. We have two years that we can use that particular isolate organism 

we got in. So, you do not have to do the process every time. Every two years, we have to 

re-isolate or just renew it. So, that is kind of a timeline. So, end of my comment. 

Wendy Fulwider: Zea.

Zea Sonnabend: Thank you for actually being a vaccine producer to come talk to us. For some of 

us who are not on the Livestock Committee and are trying to grapple with the issues, you 

explained that you could make non-GMO vaccines and you could scale up fairly easily.

Don Blake: Yes.

Zea Sonnabend: But, I am assuming you do not really want to make it for like 50 cows. And so, 

what, how, what is your minimum amount that you feel that it is worthwhile to make a 

vaccine? Is it feasible to do it on as small a scale as organic currently represents in the 

industry? 

Don Blake: On an individual basis, it would not be. But, what we can do is regionalize it. The 

USDA lets us do what is called a, it is a non-specific herd of origin. Where, we can get 

isolates in from a region. A region can be the US. It can be a state. It can be a county. 

Where we could get together multiple producers in an area, qualify their isolates, so that 

they all have basically the same problem and make a common vaccine for the whole 

group. Now, economically, that works very well. We do that all the time right now with 

current customers. It is just called a non-adjacent forms that have to be filled out. 

Comment [JMS22]: 06:15:00
Meeting Of The National Organic Standards Board

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80

Zea Sonnabend: Do you have a minimum, though?

Don Blake: Usually, for... yeah, 2000 doses would be a minimum. 

Zea Sonnabend: Thank you. 

Don Blake: You are welcome.

Wendy Fulwider: Mac.

Don Blake: Yes.

Mac Stone: [Inaudible]

Wendy Fulwider: Colehour.

Colehour Bondera: Yeah. Thank you, Don, for your, for your testimony. I appreciate it. And I 

have a, a question that I will admit I think I already know the answer to. But, I want you 

to verify. So, from what I heard you present and what I understand, you know, the 

situation that we are going to be dealing with and listening to the other testifiers, where if 

you leave, you will not necessarily be able to do, is that we are going to have some level 

of emphasis on this salmonella and poultry question. And my question to you is, from

what you said, it sounded like you could readily produce a non-GMO poultry salmonella 

vaccine. 

Don Blake: Yes.

Colehour Bondera: And that is my question, if that is a viable option to commercially produce 

such a thing...

Don Blake: Yes.

Colehour Bondera: ...at this point in time. 

Don Blake: We, we currently make a lot of salmonella vaccine. Primarily, it is sold in the dairy 

calves, but to do poultry, I mean, it, it is just another strain of Salmonella. We have all the 

cell cultures we need to grow it in. It is really not an issue. You know, I do know how 

widespread it is in poultry. But, again, we have Merial Select in Georgia that produces, I 

do not know, 600 million doses of poultry vaccine a year. They are the world’s largest. I 

do not see an issue there. I really do not. 

Colehour Bondera: Thank you.

Wendy Fulwider: Tracy.
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Tracy Favre: It is my understanding that there is two different types of salmonella vaccines: a 

live vaccine and a killed vaccine. 

Don Blake: Mmm-hum.

Tracy Favre: Can you explain any limitations in the ability to generate a non-GMO live vaccine? 

Don Blake: The autogenous outlines do not allow any modified live vaccines to be made as an 

autogenous. It is not allowed, we cannot do it. We know how to do it. The reason we 

modify modified lives, is if we do not, they will cause the disease. They will kill your 

animals. They have to be modified. That is why they call them a modified live. 

Wendy Fulwider: Jean.

Jean Richardson: Don, when we read the technical report, we were given the impression from 

that that there are about 73 or so registered livestock animal vaccines. And, from all the 

other things we have read, we now understand that as far as we know, we could get those 

in non-GMO format. 

Don Blake: Yes.

Jean Richardson: And yet, the APHIS list seems, has an inordinate number of vaccines listed, 

which makes it all very difficult, really, to understand. So can you help us to understand

the, sort of, the interface between the fact that there is about 73, which really is not a lot 

of vaccines to be working with, and that list so that we can begin to understand how we 

can assess [inaudible]? 

Don Blake: Jean, the document that you are talking about, you know, there is multiple 

manufacturers of the same antigen. Let us, we are talking about salmonella, let us stay on 

salmonella, but maybe not just in poultry. There might be several companies that 

manufacture and sell a salmonella vaccine. And in that document, it lists their, their

license that they have at their facility. It lists the license they have for that vaccine, and 

then all the other licenses. So, if you sort through that, you are right, there might be, let us 

say instead of 73 vaccines, let us say there is 73 organisms, disease entities for which 

there are vaccines. And there might be multiple vaccines for those disease entities. 

Autogenous vaccines, what we do, do not appear on any list and they are not in any 

document. They do not have to be. 

Wendy Fulwider: Nick.

Nick Maravell: Can you explain what the licensing procedures are for a company that makes 

autogenous vaccines? And whether or not autogenous vaccines are reviewed by APHIS

for efficacy, and dosage? 

Don Blake: We, with an autogenous vaccine, the only criteria we have with the USDA is we 

have to be a licensed vaccine facility. That is the same license. We also make commercial 
Meeting Of The National Organic Standards Board

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82

vaccine. We have to have that. All of our autogenous products have to be safety tested. 

Every serial we make has to go into CDB and it is safety tested. All that really says is it is 

not contaminated. On potency testing, we do not, we are not required to do potency 

testing. But, a lot of our customers require it. So, when we make new serials, we do inhouse potency testing. We have what I call non-target animal models that we have, we 

have developed to do this. We do not have to submit this to any regulatory agency. It is

between us and the customer. We do report our potency results to the customer. We do 

not have to, but we do. 

Nick Maravell: Can you explain the difference between potency and efficacy?

Don Blake: Potency means you, you make a vaccine, you inject it into an animal, let us say it is

salmonella. And then the USDA has guidelines that you have to challenge with 

salmonella, and you have to record the level of protection in that animal. Potency and 

efficacy is fairly interchangeable. 

Nick Maravell: So, you are saying your customers could require that, and you can perform that, 

but it is not required as a re-, as part of an APHIS review? 

Don Blake: It is not required. 

Nick Maravell: What about dosage [inaudible]? 

Don Blake: Dosage, again, we have a lot of flexibility. We can concentrate. Our minimum dose 

is 0.2 ml, and we can go all the way up to 5 mls. The customer determines what dosage 

level. It also is determined by how many antigens we put in a vaccine. If we have eight 

different things in there, we probably need two or more mls as an actual dosing. 

Nick Maravell: Okay. You said you can combine viral and bacterial...

Don Blake: Yes.

Nick Maravell: ...in the same vaccine? 

Don Blake: Yes.

Nick Maravell: So, you can stack a variety of vaccinates and virals...

Don Blake: Yes. 

Nick Maravell: ... in there? Can you explain what the disadvantage is of only being able to use 

inactivated or killed vaccine, organisms for use in vaccine as opposed to what would be 

considered in layman's term, a live vaccine? 

Don Blake: A modified live is, is going to be used if you have an active disease outbreak going 

on in a herd. You come in with a modified live, and generally, especially with viruses, 
Meeting Of The National Organic Standards Board

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83

because you cannot treat a virus with the antimicrobial or pharmaceutical. But, if you use 

a modified live, if there is one available for that particular virus that is breaking, it will 

pretty much stop the loss, the economic loss. It is not going to make it go away. But, it is

going to have a real impact on your death loss with your animals. That is really the 

biggest difference. There is a difference in antibodies that are produced. Modified lives 

produce a CMA, where we do an IGM and a IGA. I do not think we want to have that 

kind of broad based immunology discussion. But, for layman’s purposes, let us just focus 

on if there is a disease outbreak in a viral, modified live will stop your economic loss.

Nick Maravell: You are saying that for the viral. Is that also true if it is a bacterial? 

Don Blake: Not really. The other advantage is it is a single dose. From a, from a immune

response standpoint, a modified live is a single dose product. Where bacterials, 

autogenous, anything killed, you really have to use two doses to get your best immune 

response. There is really no way around it.

Wendy Fulwider: John.

John Foster: So, one of my concerns is about the capacity to serve, you know, and hopefully an 

ever expanding industry. And, I mean, I am pretty sure everyone in the room wants that. 

We want it to grow as much as it can responsibly and fairly and all that. So how, what 

kind of, my question is more about, I was unaware, I guess, of the new parent company. 

So what kind of capacity does that give you? And, are you able to [inaudible]

Don Blake: Well, it gives us access, it gives us access to two more very large commercial plants.

Now, I cannot say we can, you know, they, they are not maxed out, either. But we could 

in emergencies, have them produce some of our antigens. At this point, I do not know 

how much that would be. You know, we have only been part of Merial since the very end 

of March. But, they have offered this to us. So, we have it available. But, I have never 

really had an issue with a large customer where we could not meet the demand. And as I 

said, you know, some of the, I deal with some of the largest food companies in the 

country right now. Not with poultry, but with pigs and some of them have huge demands

for vaccine. But, I mean millions of doses at a time. 

John Foster: Well, what I am hearing is that that scale is kind of giving you comfort to make sure 

that you are, you are going to be able to accommodate that. That is all.

Don Blake: Autogenous, scaling up on autogenous is so much different than scaling up 

commercial. It could be done so quickly and for a lot less money.

John Foster: Thank you.

Don Blake: Mmm-hum.

Wendy Fulwider: Tracy.
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Tracy Favre: Just a point of clarity. You made a comment that a live or modified live vaccination 

is used for an outbreak. Is there any reason to use a modified live as a preventative in, for 

instance, the case of salmonella? 

Don Blake: Yes. It, you will get a strong immune response, and you only have to give one dose.

So that there is a convenience factor there. 

Tracy Favre: So, could you accomplish the same results with a killed virus with two doses? 

Don Blake: Yes. If, if we are talking about, from an immune perspective, yes. 

Tracy Favre: Thank you.

Wendy Fulwider: Jean.

Jean Richardson: How easy would it be to generate a list of non-GMO vaccines so that the 

individual farmer and the certifying agency would be able to have, ask the right questions

so to speak at the time they are deciding what vaccines to use and that would include of 

course listing, being able to get access to autogenous vaccines?

Don Blake: Mmm-hum. Jean, it, it is hard to, to say because commercial companies, you, you are 

getting into their intellectual property. There is a lot of things they do not have to disclose 

to the public, and they will not. However, part of their marketing materials will have that 

information in it. And what you really want to look for, in a GMO product, you want to 

look for vectors. There is a lot of the commercial vaccine that is put into a vector. And by 

your definition, it has been genetically modified. Because, they will take some, you 

know, amino acid sequences out of the disease organism, and they will put it into a 

benign vector that does not cause disease. And that is your vaccine. 

Marketing materials have a lot of this information in it. But, the manufacturer does not 

have to disclose that to the public, on what they have done or why they do it. So, I do not

know if I answered your question, but I would start with practicing veterinarians, they 

have access to the commercial vaccine companies that give them marketing materials.

And, you will have to, I do not know of any other way to do that. I do not think you can 

look at the license itself. I do not think the general public is going to get, like, you cannot

look at my licensed vaccines. I would not show it to you. 

Wendy Fulwider: Nick.

Nick Maravell: We heard in earlier testimony that autogenous vaccines have a more narrow 

spectrum as to the strains of, let us say, salmonella, that they might protect against. And 

do you feel that that is a limitation? You were describing the ability to come up with 

regionalized autogenous vaccines.

Don Blake: Well.
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85

Nick Maravaell: Is, is an autogenous vaccine going to be seen as less able to cover a broad, 

broader spectrum? And, I do not know how essential that is to production at this point, 

but [inaudible]. 

Don Blake: Well, of course. That is the reason for our existence. 

Nick Maravell: Right, by definition. 

Don Blake: Again, we go into the, the herd, and even to an area, and we identify all the strains of 

salmonella that are there. We do not make a broad-spectrum product. We put in it what 

we found. So, it, it is targeting exactly what we found. You are getting the disease that 

you had in your herd, that you had in a region, that you had in non-adjacents. So, the 

argument is not about if it is broad. If I made a commercial salmonella, I would have to 

make it broad. But, I, I am limited there because I cannot cover everything. But 

autogenous, I can. 

Nick Maravell: Right, right. I understand. We have also heard about the difference, in terms of 

how quickly or how strong of a take or a reaction, if you will, you get from an

autogenous vaccine that may have to be administered, or, or a vaccine that is using 

inactivated organisms versus a live vaccine may have to be administered at a later stage 

of development of the animal or may have to be administered twice, which is what you 

have said. So, do you see some disadvantages then to the autogenous vaccine, in terms of 

how strong of a reaction, how well it takes composed, as opposed to a live vaccine? 

Don Blake: I, I think that is a convenience factor. You know if you are going to deal with a... In 

the livestock industry, you know if you have parent animals that are producing offspring, 

and you need to vaccinate the offspring, then you want to rely on maternal antibodies.

You have got to let them do their job. You cannot vaccinate with a killed product in the 

face of maternal antibody, a high level. Now modified live can come in and, you know,

reformat that whole immune system, if you want to, want to do that. But, you have to 

wait for your maternals to drag out, then you can effectively immunize with the killed. So 

it might be a convenience thing. Somebody might say, look I will vaccinate young 

animals because I can do it. I do not want to wait until they are this old.

Wendy Fulwider: Thank you, we need to move on now. 

Don Blake: Okay, thank you. 

Wendy Fulwider: Nick, if you would like to continue your presentation.

Nick Maravell: Sure, Wendy. Was there a slide or two I should be talking to? 

Wendy Fulwider: Michelle, if you could [inaudible].

Nick Maravell: Okay. What the Livestock Committee found was that we kept getting more 

information, which generated more questions. And, we went through a process and, in 

Comment [JMS23]: 06:30:00
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86

reviewing the technical report, we came up with some key questions as we went through

our, that were not answered by the technical reports. They were not necessarily posed to 

the contractor. 

Then, as we went through our deliberation to come up with a recommendation, there 

were obvious questions that also emerged. Such as, why do not we make a list so 

everybody knows and is playing off of the same sheet of music? This is a vaccine. This is 

its name. This is the disease it treats. It is either produced with excluded methods, or 

without excluded methods. That we, we would really love to see such a, a document. 

Then, we came up with questions that we wanted to hear more information from the field.

What would be the impact on the industry? What were the different types of species that 

were particularly in need of vaccines produced from excluded methods, etc.? And then, 

we went back to the Program and said, this is what we are thinking about, but, do you 

have questions that you want answered or think that would be valuable in proceeding 

with this issue? So, we sort of have four sets of questions. And, some of them will flash 

up on the screen. I am not going to go through all of them, maybe one or two. 

One obvious question is: what specific disease problems can only be addressed with a 

GMO vaccine? And, we are not 100% on the answer to that question. We have got a lot 

of good information. Wendy has gone out and gotten us additional resources to consult. 

And, we are getting closer. But, we are not there yet. 

Another question that we have, and I am going to put this off to the side, we did make a 

recommendation, with regard to emergency use. And, I should put a little bit of a preface 

on this. Vaccines generally should be used as a preventative 99.9% of the time. That is

where vaccines are effective and should, desirable. There are instances beyond the 

control of normal events, and I, you know, I hesitate to mention these, but there are the 

realistic possibility of bioterrorism, and there is the realistic possibility of what are called 

foreign animal diseases, such as hoof and mouth disease coming onto these shores. In 

those instances, it is not always possible to have the tool in your box to meet the 

emergency. It is, though, a very hopefully rare occurrence, and so, the committee made a 

recommendation that in that instance where a federal or state official declared a state of 

emergency and mandated, required, all producers, not just organic producers, to 

administer certain treatments under that circumstance, we were making a 

recommendation that the Secretary change current policy and not exclude the organic 

products that would be affected: livestock and livestock products, such as milk, eggs, 

slaughter stock, young stock still in the last third of gestation in mammalian species, etc.

And our reasoning on that did not fall directly from the statute. So, we are going out a 

little bit on a limb on this. It would create multiple years of recovery for the organic 

livestock industry. And, you can debate how long that recovery would take. But, it would 

be a, a financial issue. It would be a major impact. We felt that if it was explicitly 

described to the consumers that they would understand, the entire country, the entire state 

was pulling together to meet a public health need. So, we felt it was justifiable. But, there 

is not an explicit criteria there in the statute. So, I just want to make that clear. 
Meeting Of The National Organic Standards Board

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87

So, what we would like to do with, hopefully, with the remainder of our time, is we really 

want to hear from the public. We want the ability to have some back and forth, like we 

just did with that witness that had to catch a plane. So, we can truly understand the needs, 

and we are looking for your ideas as to what the next steps should be, as we move 

towards a policy on vaccines, GMO vaccines. What are the next steps that you would like 

to see take place, and who should be involved in those steps? Second, if this – these list 

of questions are up on the website – if there are specific areas that you would like to 

address, related to these or other questions, or you think there are questions we should 

add to our list – we are not sure exactly how these questions are going to get answered 

right now – we would like to hear that as well. So, we are looking for the next steps and 

we are looking to gain more information. 

Wendy Fulwider: So, we are ready to start public comment. Bob Beauregard, if you are here. 

And, Mohammed Mousa on deck. 

Bob Beauregard: Good afternoon. To the new members, welcome. Good luck. 

Unknown Male: [Laughing] 

Bob Beauregard: My name is Bob Beauregard and I am the general manager at the Country Hen. 

We are a small organic egg farm located in central Massachusetts and have been in the 

egg production business for, since 1988. 

The Country Hen does not support the use of excluded methods in the production of 

organic seeds, crops, ingredients or other production methods. We have signed petitions

endorsing the fight against GMO Round-Up Ready alfalfa and the mandatory labeling of 

GMO foods, ingredients produced by the means of excluded methods. We also support 

the proposed letter – [cough] excuse me – to the Agriculture Secretary Vilsack from the 

Ad Hoc Committee as well as support the national, the GMO vaccine comment submitted 

by the Organic Trade Association. 

The National List identifies all vaccines as a group as synthetic substances allowed for 

use in organic livestock production, 7 CFR 205.603(4)(a), Biologics, vaccines. Although

we clearly understand why GMO vaccines are being questioned, we do not understand 

the Livestock Committee's rationale to use these vaccines for emergency cases only. 

Vaccines are essential in livestock production, and are specifically listed as preventative 

health care practice in the NOP regulations. The proposed LC document is inaccurate, 

lacks information with regards to the use of GMO vaccines in organic livestock 

production. There are many unanswered questions. Furthermore, the recently signed 

equivalency agreement between the United States and the European Union allows the EU 

organic livestock producers to market their products, potential, potentially produced with 

GMO vaccines, in the United States, which puts the US organic producers at a 

disadvantage if some of the vaccines are only produced as GMO and are thereby not 

allowed to be used in the United States. 
Meeting Of The National Organic Standards Board

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88

We respectfully request that this proposal be withdrawn, which you have already done.

And, we thank you for that. But, this comment was prepared, obviously, flying in on the 

plane. We know that more work is necessary. Difficult to answer questions for endovaginal vaccines must be addressed. We support the idea of specific lists that can be 

created and determine non-GMO and GMO vaccines as guidance for producers and

vaccine manufacturers. Thank you for your time, your service and your consideration to 

the issue.

Wendy Fulwider: Thank you. 

Nick Maravell: I have a question.

Wendy Fulwider: Oh.

Nick Maravell: I have questions. I have questions. Could you describe your vaccination 

protocol...

Bob Beauregard: Schedule...

Nick Maravell: Schedule, yeah and, also, how you are responding to salmonella as a, as a total 

management program of which vaccination is a part? 

Bob Beauregard: Okay, so earlier, John basically described his. 

Nick Maravell: Mmm-hum.

Bob Beauregard: And, ours is pretty much the same. 

Nick Maravell: Okay.

Bob Beauregard: We are using, you know, the, the 4 to 6 week, and then the, you know, the 10 to 

14 week vaccination program. One is a live version, one is a killed version. It is all done 

in the pullet Stage. It is being done. We, we have always used a salmonella vaccine. The 

egg prevention, FDA egg prevention, salmonella prevention plan that came out, 

obviously, that is suggested by the FDA that you use that as a prevention method. It is not 

required. It is not mandated, same thing that John said. And that is pretty much the 

program that we are using. Obviously, we, we are keeping our farms clean. We have 

different areas of production. We have got one farm that has 50,000 birds on it, but, they 

are all in small flocks, between 65 hundred and 7 thousand birds in each flock. But, then 

we have farms that are not on that address that you have to have separate prevention 

plans for. We have those plans set in place for this coming July. So, you know, the 

smaller areas will be inspected come this October. The bigger areas have already been 

inspected. So, as a prevention plan, you want to put everything in that plan that is going 

to prevent salmonella from, from entering. 

Nick Maravell: So, you are administering twice now.
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89

Bob Beauregard: Yes.

Nick Maravell: And, if those vaccines do not contain excluded methods, that would, that would

be just fine with you? 

Bob Beauregard: That is the ultimate. 

Nick Maravell: That is the ultimate.

Bob Beauregard: That is our goal. 

Nick Maravell: That is your goal, alright. So, if, if you can get that, that will satisfy your 

production needs.

Bob Beauregard: Exactly. We just need to know which ones they are because, our certifier, since 

day one, has requested that we get statements from our vaccine producers that a nonGMO statement. So we have done that since the day we were certified. And that 

statement, I think, may be what is more in conflict than the vaccine. I mean, so that is 

where the producers and certifiers are as confused as to what vaccines are actually GMO

and non-GMO. So, that is where we need the clarity, as producers.

Wendy Fulwider: Joe.

Joe Dickson: I think, actually, I think Bobby just answered the question that I was going to ask. 

So you, you do not feel that you have sufficient information from your vaccine 

manufacturers to determine...? 

Bob Beauregard: Well, I mean as the gentleman, as the gentleman just spoke, I mean, some 

manufacturers are not going to disclose the methods of the production of their vaccines. 

So, I mean, they can tell you that it is non-GMO and that is what you have to go by. But, 

do you really, really know that? You know, so that, there is the question in my mind as to 

that. 

Wendy Fulwider: Mac.

Mac Stone: So, what does that non-GMO statement say? What do you get from [inaudible]?

Bob Beauregard: It says that the vaccines are not produced using excluded methods. So, that puts 

it in the non-GMO category. And that has satisfied the certifier. But, it has always left the 

question.

Wendy Fulwider: Tracy.

Tracy Favre: Did I understand you to say that in your two rounds of vaccination, one is a killed, 

and one is modified live? 

Comment [JMS24]: 06:45:00
Meeting Of The National Organic Standards Board

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90

Bob Beauregard: That is correct. 

Tracy Favre: Can you explain why you do both? 

Bob Beauregard: Well, we do one in the beginning which is the live version, and then we use the 

killed version as a booster, which was suggested from our vet, our veterinarian, poultry 

science specialist Mike Dairy, from the University of Connecticut. So when we, when we

built our vaccination program, this is how it was built. And this is what we have done all 

over these years, you know.

Tracy Favre: We heard in the previous comments that it is possible to get a similar immune 

response with two applications of the killed virus. Would it be possible, or would you 

consider doing two rounds with killed virus versus one live versus...? 

Bob Beauregard: I would certainly discuss that with the veterinarian. If he feels good about it, 

then I would feel real good about it. 

Tracy Favre: Okay. 

Wendy Fulwider: Thank you. Harriet, you are up next. Yeah.

Mohamed Mousa: My name is Mohammed Mousa. Thanks for the Board and thanks for the 

Program and the team. Issue with the vaccine: the question is why we vaccinate. Much 

money was spent for the vaccine, and what we vaccinate for. We vaccinate to protect the 

birds from very fatal diseases. There are several of them. There is viral. There is 

bacterial. There is protozoa and there is mycoplasma. 

For the viral diseases, I made some information, because I have only three minutes. So, 

you can read it on, on that. The viral diseases have more advanced vaccine than any other 

disease because, it has been implemented and there are so many research has been done 

on that. There is about 12 viruses can kill the chicken from day one. There is some of 

them have very short an incubation period, there is like IBD and Newcastle, and LT, and 

there is some of them have very long, like Marek’s Disease and Laryngotracheitis, 

Lymphoid Leukosis, and others. 

The issue was, was GMO vaccine or non-excluded methods, we are not educated enough 

in the field to know exactly how that vaccine produced. There rather some vaccine which

it has a donor and a vector and you, they take part of the donor, and put it, and they call 

that, it say HVT, IPD, and so on. Those five of them and they are very known. Most of 

those vaccines can be done in a day one. But also, I do not know too much about exactly 

how they do it. They do not tell us. The other vaccines, which is normal vaccines, we call 

them, we do not also know how they do that. How they stop the virus from growing, and 

become attenuated virus. The method of attenuating that virus, if they use chemical in it, 

is this considered GMO? I do not know that. 
Meeting Of The National Organic Standards Board

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91

The other issue is bacteria. The bacterial infection, if it is E. coli, or if it is salmonella, 

and there is Clostridium, and there is others. I will just specify those. E. coli can kill 

approximately 25% of the floor raised birds if it is very, very vicious bacteria. When I 

open birds, the septicemia which happened to the organs and the damage to the liver and

the, the gizzard and the spleen and the ovary and all that, when you open the bird, you 

feel very sad for that bird. E. coli, it must be vaccinated for the floor birds. In a cage 

facility, we do not vaccinate for E. coli at all, because we separate the birds from their 

feces. If the birds are in the floor, they are raised with their feces. There is recycle in here 

in the bacteria and the bacteria gets stronger and stronger as it cycles. 

The other issue, issue of salmonella and the food safety: Salmonella will not cause very 

disturbance to the chicken too much, unless the bird is weak. If the bird is weak, E. coli 

comes on beside it and cause a lot of damage. Salmonella is a human health issue. The 

gentleman who was before, before Bob talked about the autogenous, autogenous

vaccines: they do not work. We have prevention, like what Nick said. You cannot wait

until you have a disease and you kill the chicken then you make a vaccine. And it is

narrow targeted. It is more suitable for larger animals like cattle, sheep, goats, bison, 

other large animals. 

Wendy Fulwider: Questions?

Nick Maravell: [Inaudible]

Wendy Fulwider: Nick.

Nick Maravell: Could you amplify a little bit or explain some more? You are saying that the 

autogenous vaccines do not work. Is that what you said? 

Mohamed Mousa: Yes, that is what I said. 

Nick Maravell: Okay. Now, one way to produce an autogenous, well, the only way to produce an 

autogenous vaccine is, is to have lesions of some sort that you can then culture out and 

use a killed bacteria to create a vaccine. Can you explain from your experience how 

autogenous vaccines fail to work effectively? 

Mohamed Mousa: The birds – the chicken, general poultry – is the only creature we raise have

another wild reservoir in the air. There is birds, if you step outside now, you are going to 

see birds, you are not going to see cattle or sheep or others. The recycling from the wild 

reservoir always a change, and when you isolate that virus or that bacteria from the 

environment, it is specifically for that virus. If there is any mutation, it does not work. I 

used it with mycoplasma. It did not work. I tried it to see if, if is here that I talk to him, it 

did not work. Because it was mycoplasma, I had to get an F strain and Microvac L from 

commercial vaccine to use it, because the local one which I had, they changed it and it 

specific for that organism. 
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Nick Maravell: So, you, you are not seeing the possibility to control salmonella with an 

autogenous vaccine because of the reservoir in the wild flocks...

Mohamed Mouse: It have...

Nick Maravell: ... you always introduce additional strains? 

Mohamed Mouse: In, in the situation of salmonella, it would have to be targeted, a special strain. 

We have about 200 and some strains of salmonella. You have to have that target. And 

when you change the flock, then what do you do if you have another one? Plus, the 

autogenous vaccine is very expensive. 

Nick Maravell: Okay, so it is more expensive than commercially available? 

Mohamed Mousa: About 10 times the cost. And, the small producers will have a hard time to get 

into that, unless they have resources, you know, somebody to help them with grant or so

that they can get that vaccine if that is the way it goes. 

Nick Maravell: Okay.

Wendy Fulwider: Will you still be here for a while if we have additional questions?

Mohamed Mousa: I will be, but I want to say I support taking all GMO out from the organic 

production, but, we need to reserve for the life of the bird and the health of the bird. 

Thank you. 

Wendy Fulwider: And Aaron Brin is on deck. 

Harriet Behar: Hello, everyone. I am Harriet Behar with MOSES, and I am also a, MOSES is 

also a member of the National Organic Coalition whose diverse stakeholder group of 

farmer, consumer, environmental, retailer and handler organization strives to aid your 

work in maintaining organic integrity and trust in the organic label. First, I would just 

like to give a statement about animal welfare. 

While there are some useful suggestions in the animal welfare recommendations, since 

many of these came directly from animal welfare standards that were developed in 

reaction to conventional confinement and industrial style agricultural systems, many of 

these suggestions do not quite fit with organic systems. I have concern that the numerical 

guidance will be used literally by certifiers, which would result in stifling innovation in 

the development of systems that recognize the symbiotic relationship of livestock with 

their ecosystem. When there are numbers applied to an assest-, assessment, certifiers and 

inspectors tend to use them to evaluate a farm in a snapshot type fashion, rather than an 

evaluation that assesses the organic system that is in place over the full year. 

Now, on GMO vaccines: And I just want to refer you to the NOC and my own written 

comments because we do not have much time up here. 
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93

So, the first issue with GMO vaccines is we are really dealing with two issues here. We 

are dealing with GMO vaccines that may be used currently in organic production, and 

those are being used illegally. The Office of Inspector General has said that, and we need 

to use the system that we currently have in place to deal with those vaccines. Those 

vaccines need to be petitioned and put before the Board. However, your current review 

criteria is, probably is not going to be able to deal adequately with this novel technology, 

and you may look to increasing the questions that you put to those materials. So, I, I refer 

you to the NOC questions that we have in our written comments. 

The second is the emergency issue. And I believe this is an animal welfare issue, as well 

as one that could affect the livelihoods of many organic livestock producers, as well as 

the health of the organic marketplace. We believe that if you are going to be looking at 

this emergency exemption, it should be moved over to the temporary variants section, 

205.90, and make a new 4(a) through (d), which is what we recommended in our NOC

recommendations. But, we among NOC are not 100% sure that we really want to support 

GMO at all in organic, but we are concerned about this emergency need. If the vaccine is 

allowed, one thing that was not included in your recommendation was that it would be 

eventually reviewed. So, we feel like it is very important that if there is an emergency 

exemption, that that immediately triggers a technical review and that within 18 months, 

you guys are at least talking about it. And then, maybe there would be an annotation that 

it would be for emergency only. Any questions? 

Wendy Fulwider: Nick.

Nick Maravell: Could you explain what you think the current impact would be on producers, 

were they to administer a GMO vaccine in an emergency or otherwise? Well, let us say in 

an emergency. What would be the economic impact? What, what would be affected? 

How, how deeply would this run in the organic livestock community? 

Harriet Behar: Well, if it, if it was being enforced as the rule is written, those animals would be 

taken out, the, well, their products would be out of organic production. So, a dairy 

producer would have to, would stop selling organic milk, would have to find a market for 

their conventional milk. And I am not sure how we would deal with it. They would 

probably have to be transitioned or, our rule does not allow for a dairy herd to be retransitioned into organic production. So they would either have to start out with young 

stock and raise those up organically. So, a dairy producer, – if they were raising all of 

their own animals and not bringing in new animals – it could be two years. Obviously, for 

a poultry operation, they could bring in day old chicks and start out new and fresh. But, 

they would have an investment in organic feed in those animals that would be lost, 

because since they could not sell them on the organic marketplace anymore. And a lot of 

times, the conventional marketplace is not necessarily open to the organic producer 

[snap] like that. You know, a dairy producer might not find a conventional buyer for their

milk, you know, the day after they have given a GMO vaccine.

Wendy Fulwider: Tracy.
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May 23, 2012

94

Tracy Favre: Hi. 

Harriet Behar: Hi. 

Tracy Favre: I am intrigued by your comment about the animal welfare standards not being 

prescriptive with numbers. And, I would like your input or your thought on how you 

create an out gum, outcome based program without relying on prescriptive numbers.

Harriet Behar: Okay, well as an example, we have a rule right now about buffer zones, which 

have to be of sufficient size to prevent unintended application of prohibited substances. 

And that is then reviewed on a site-specific basis. And that is a discussion between the 

certifier, the inspector, and the farmer. If someone has got a row of arbor vitae trees that 

are 10 feet wide next to a conventional field, their buffer maybe 10 feet. If someone is 

next to an operation that is aerial spraying, they may have to have 100 feet or more of 

buffer zone. So what we have given in the regulation in many places in our regulation is a 

vision of what we want for organic agriculture. And we have been allowed the producer 

to put forward a way to meet that regulation through a systems-based approach. 

So, there are things. I mean, there is a thing about prevention of abuse and having 

perhaps a minimum number of things, of numbers. But, as far as having, you know,

cleanliness scoring, that sort of thing, when you are there in a snapshot... I was an 

organic inspector for many years. I could show up after a 4 inch rain. Those animals 

could be having difficulty walking. They could be filthy. You can have an inspector who 

does not under.., who just flew in from somewhere else. And then that farmer, whose 

system throughout the year could be very good, but had, just had an extreme climactic 

event, would be penalized. And, and their report, even if they maybe would not have lost 

organic certification, it would be a permit record of their farm, you know, looking poorly. 

And a lot of these animal welfare standards are based on really confining the animal, 

having them in much more controlled environment than we in organic see as the 

beneficial system between the livestock and the ecosystem. So, when they are outside, 

they are going to, you know, get cut. They are going to be dirty, you know, there is, there 

is things that happen when they are interacting with their environment. When you have 

them in a more controlled, you know, you have them in a freestyle barn, all on clean 

sand, where they, you know, walking on concrete, they do not get as dirty. And there is 

just, we, we know we have less control in the natural environment, but we also know that 

is where the animals should be. 

Wendy Fulwider: Tracy.

Tracy Favre: As you might imagine, in my regular job, I am very much about systems based 

methodologies and processes. So, how do you balance the need for objectivity in 

standardizing evaluations with a systems approach that is on a case-by-case basis?

Comment [JMS25]: 07:00:00
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Harriet Behar: Well, as an inspector, you should be sticking to the facts and talking about what 

you saw. And a good inspector will ask the farmer, why are the cows so dirty? What 

happened yesterday? Why is this area causing an injury? Or, or whatever it might be. 

And so, that is then given to the certifier, who is actually the one supposed to be making 

the decision anyway. And so, in a descriptive sort of way, you are discussing the whole 

organic system. You are discussing what you see there that day. But, the inspector should 

also be discussing overall what the farmer should do. And rather than kind of writing 

down just a score, that really the farmer does not have much input into, there is a 

discussion with the farmer which the inspector then puts in the report about what the 

farmer had described as their challenges, and how they were meeting those challenges on 

the farm. 

Tracy Favre: Thank you. 

Wendy Fulwider: Zea.

Zea Sonnabend: Thank you. Apologies if this is a naive question, Harriet. But, the gentleman 

earlier who said he could make any vaccine as a non-GMO, which appears like it could 

solve the whole GMO vaccine problem, and I am curious what you thought about that 

and what challenges there might be in believing that. 

Harriet Behar: Good question. And, I was myself was thinking about it, and I am mostly 

speaking now for myself and for MOSES than I am for NOC. Well, I, I really think that 

there is an issue with an emergency. There could be a time when the Secretary or a state 

official might declare a mandatory vaccination for animals or, or a destruction. That is

your choice. Of course, most farmers would choose to vaccinate. And, we would not

want those farmers to then lose their livelihoods in the organic industry. So, so I think 

that the development of vaccines, anywhere from 4 to 8 weeks, could be too late for the 

type of outbreak that we are looking at for this type of emergency. But again, if it is then 

reviewed by the NOSB, going through a technical review, if any GMO vaccine is 

approved for that emergency use, it immediately must trigger a, a review. No petition 

necessary, just get it here. So then, there can be further deep thought about, is there 

another way to do this, because, an emergency is basically to avoid a catas-, catastrophic 

situation.

Wendy Fulwider: Nick.

Nick Maravell: Harriet, could you give us your thoughts on what would help to administer a

policy with regard to vaccines, which could, could potentially include excluded methods? 

What would it, what would be necessary, what would be necessary for you certifiers, 

producers, inspectors. What would it be necessary for them to, to have available in order 

to do this? 

Harriet Behar: Well, the, the comments that both NOC and myself made by putting it into the 

temporary variants, where we mandated that the Secretary and the National Organic 

Program both discuss this emergency. Is it truly an emergency? And, like I said, that 
Meeting Of The National Organic Standards Board

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96

there is a mandated review, that there is, hopefully the NOP will be able to help us figure 

out in a short timeframe. Is there truly no non-GMO alternative? Those are the, the items. 

That is a beginning. I do not say that what we proposed is a final, but, but I think that our 

written comments were quite well vetted, at least amongst the National Organic Program 

members of, of trying to make it so the emergency would not be abused. That there 

would be a limit to the emergency and it would not go on for five, six, seven, 10 years 

with no review. And that, but, but at the same time that we were providing to those 

organic livestock producers the safety net that they need to remain in organic farming and 

to take care of their animals. 

Wendy Fulwider: Thank you. Nancy Coonridge on deck.

Aaron Brin: [Inaudible] You ready for me? Hi, Wendy. Thank you. My name is Aaron Brin, I 

am the new inspection manager at MOSA, Midwest Organic Services. We certify over 

550 dairy farms in the, in the Midwest, over about 15 states. And, we have over 700 

livestock operations that we certify. I am also working with about 42 contract and staff

inspectors. And, I was looking at your discussion document, again, about methods of 

verifying animal welfare and that you believe outcome based scoring is the best measure 

of farm animal welfare, and that made me feel like I should comment on that some. 

We are glad, Wendy, for your clarification that your, you do not expect inspectors to do 

body condition scoring, cleanliness scoring and all that on every form in every situation. 

That would be really a burden. It would be very expensive. And it, it really would not get

us any further along than we are now. 

What, what I think about this, and, and some of this is similar to what Harriet was talking 

about, is we have to look at it in terms of a broader context of, of certification, where 

there is inspector and reviewer. And the inspection report, I feel, basically is an

appropriate document for communication between the inspector and the reviewer who 

makes that certification decision about animal welfare issues. 

I can see that numerical scoring can be an adjunct to that report. But, it is, it is limited. It 

is oriented towards the animals’ condition. It does not describe the organic system plan, 

or the situations in the organic system plan that have given rise to those problems in the, 

in the animal or the animal group. 

We have used, in place of that, we use photographs extensively, so that again, the 

reviewer is getting information from the inspector, which is an observation, a verification 

of the organic system plan, but it does not look like a judgment or an attempt by the 

inspector to make a certification decision. And, I think that is an important distinction. I 

think, actually, numerical scoring can be well used by certification reviewers when they 

are making decisions about animal livestock issues. I also think unannounced inspections 

are something that would be a really valuable tool to look at, besides scoring. Thank you.

Mac Stone: [Inaudible]
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97

Wendy Fulwider: Yeah. Mac.

Mac Stone: If you get an inspection report and it indicates that they are too thin or their poultry 

are too crowded, or outdoor access, how do you educate or help that customer fix the 

situation? 

Aaron Brin: Right, you know, in most cases of animal welfare issues, I think that the final 

reviewer is going to issue a minor non-compliance with a need for correction. There may 

be situations where the system is so badly broken that, that it cannot be certified. But, 

mostly, it is going to be a minor non-compliance with a clear description of what the, 

what we expect our correction to be. And, that would be a situation where if you are 

seeing a very thin animal, and you have a picture of that animal and it looks like it is 

malnourished, you can say to that farmer, we will expect within x number of days that a 

veterinarian or some other professional will come back and score your animal and your 

animal will be up to the next highest level, or, you will not have corrected the problem. 

Wendy Fulwider: Thank you. Nicole Dehne on deck.

Nancy Cooridge: Hi. My name is Nancy Nathania Coonridge, and I am an organic dairy goat 

farmer in the wilds of New Mexico. I have been up there for 30 years now, producing 

wonderful cheese. And, since many, you know, citizen - I am here as a citizen lobbyist. 

And, I am a member of Cornucopia Institute. And, groups like that really cannot afford to 

get paid lobbyists and paid lawyers and paid, you know, witnesses. So, you got me.

If the goal of developing animal welfare standards and guidances is to satisfy the 

concerns of our organic consumers, and the animal welfare community, this goal is not 

being met. And, if the goal is also to create a viable marketplace alternative to inhumane 

and unhealthy conventional livestock production, then the NOSB must reconsider the 

direction that it is taking. As it stands right now, the recommendations do not meet the 

expectations of my organic consumers, and the, and the animal welfare community. And 

it places ethical, family farmers, like myself, at a, [sigh] at a disadvantage, because we 

want to follow the spirit of the, of the organic standards, and if other people are just 

skimming along, where does that leave us? 

The most important thing, I think, is why is the Livestock Committee so focused on 

spending time and resources on guidance recommendations? The purpose of certification

systems are to assure consumers that certain standards are being met, and that all farmers 

are following those same standards. And listen, I have been living out in the wilds of 

New Mexico for 30 years, it is hard for me to say, give us more standards. But, I want 

everyone to be on a level playing field with this. So, there is guidance documents right 

now in place that certain standards need to be met, but it is just recommendations. Let us

make them rules, okay? Let us have everybody following the same rules. Thank you very 

much. 

Wendy Fulwider: Questions? Calvin.

Comment [JMS26]: 07:15:00
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Calvin Walker: What type of livestock you raise? 

Nancy Coonridge: Dairy goats. 

Calvin Walker: Dairy goats. 

Nancy Coonridge: Absolutely, they are the best. And they get no respect. Okay, I agree. I agree.

Crowd: [Laughter]

Wendy Fulwider: Thank you. Christopher Ely on deck.

Nicole Dehne: Hi. My name is Nicole Dehne. I coordinate the certification program for Vermont 

Organic Farmers. I want to thank the Board for the opportunity to speak today and for all 

the hard work you all have put into these documents. 

VOF appreciates the Livestock Committee's commitment to continue their work to refine 

animal welfare recommendations. It is very important. We believe that the NOSB should 

try to create standards that invest the concerns of consumers and assure animal comfort 

and care while remaining practical for farmers, both in assessment and application. So, 

we do believe though that strong animal welfare recommendations, recommendations

should include tools, like the NOSB scorecards from making a quantitative assessment 

regarding animal welfare. We have provided body condition scoring training for 

inspectors, not to make them fluent in body condition scoring, but to give them language 

and foundation to describe their concerns. So, we ask our inspectors right now to report 

back on basic animal welfare assessments, and I have include it in my written comments 

examples from our inspection report. 

But, in addition, it should be understood that VOF inspectors are trained to involve the 

farmers in their assessment of animal welfare. So the inspection report should include not 

only a description of what the problem is, but how the farmer is addressing that problem 

or whether they even believe that they have a problem. So, if... We feel that if ACAs are 

going to continue to improve our assessment of animal welfare, we are going to need to 

make judgments about the condition of care on the farm. And we are going to need tools 

like the scorecards presented by the NOSB to make these judgments fair and consistent.

So, without specific guidelines that are quantifiable, we are, we are afraid that the 

recommendations will be too vague, and it will be difficult for ACAs to cite farmers for 

animal welfare non-compliances.

So in regards to vaccines, we support the withdrawal of the recommendation. It was said 

yesterday, we live in a polluted world and I would also contend that we live in a bit of an 

imperfect world where in a small number of cases, and I think they are small, GMO

vaccines may be the only vaccines available to farmers who strive to present disease in 

their herds and flocks. So we currently have a list of all the vaccines that are used by our 

producers. What we do not yet have, I will stress yet, is the criteria or process by which 

to evaluate whether or not those vaccines are GMO. And, we are, we would like to better 
Meeting Of The National Organic Standards Board

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99

understand what criteria APHIS uses to determine whether a vaccine is GMO, and how 

that lines up with our NOP definition of excluded methods. 

So we support the Committee's efforts in developing a compromise to ensure that farmers 

have the vaccines that they need to prevent diseases, be it in an emergency or routine. If 

the NOSB recommends allowing limited GMO vaccines, based on the fact that there are 

no alternatives, then our job as an industry would be to educate the organic consumer 

about why this is necessary and important for the viability of our organic livestock 

producers. So, we would contend that organic consumers are vital to the success of the 

organic industry, but so are our organic farmers. 

Wendy Fulwider: Okay, thank you. Any questions? [Inaudible] Christopher? We will be taking a 

break after Christopher's comments. 

Christopher Ely: Hi. I am Christopher Ely, co-founder of Applegate. We have been in business 

for over 25 years. I am also a PAACO certified animal welfare auditor. And I am thirdgeneration farmer, having grown up on a Angus farm, turkey farm in the state of New 

Jersey. And yes, there are nice place, parts of New Jersey. 

Applegate would like to thank NOSB for its hard work in establishing the animal welfare 

recommendation and guideline for organic livestock and poultry. At least 95% of the 

organic livestock and poultry raised for Applegate today are by farmers, who have 

transitioned from conventional farming to organic. These converted farms are not the 

CAFOs that we all read about, but rather small, family farms that have invested in one or 

two barns purposely built to raise either their chickens, their turkeys, their pigs, whatever 

they were raising. 

The number one reason for their switch: with the total disillusion, with the conventional 

livestock industry, from the practices of over-crowding, and lousy elusive returns on their 

investments. Most of these farms are on properties where they practiced diversified 

farming. Most of them are still paying off the loans not only for the initial investment to 

build these barns, but also for the consistent pressure put on by the conventional 

contractors to upgrade their barns. If organic is truly going to compete with conventional

farming, contribute to the overall food supply in the world, then we have to design

standards that are realistic and allow farmers to easily come over to the organic way of 

life without creating a financial strain in the process. We need to continue to grow the 

organic agricultural model in order to satisfy the ever growing consumer base that 

demands organic products. 

On average, the size of our turkey organic flocks are in housing designed specifically to 

hold an average of about 6500 birds. You know, this is based on the recommendation of 

7.5 pounds per square foot. They are also given outdoor access. Since these growers grow 

in space requirements to achieve the best... Excuse me, I am losing my place here.

[Laugh]
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Our concerns, though, are about the outdoor standards. As written in the, in the guideline 

proposal, they are saying 2 pounds per square foot. If we use these calculations, this 

means that they would have to get over two and half acres per barn for outdoor access. 

Unfortunately, the majority of these barns were not designed to accommodate this

requirement, due the proximity to other agricultural structures, rip, riparitory [property?] 

boundaries, roads, houses etc. I have already been notified by most of our farmers that 

they will no longer be able to grow organic turkeys if they are required to use these space 

requirements. The industry indicates, the industry estimates indicate that we have already 

lost about 30% of our organic grain growers in the United States. All have said the same 

thing. The configuration of their barns and properties would not allow them to increase to 

this area. So our recommendations, if we could have the indoor standards match the 

outdoor standards, that would be applicable and work for all of them. Thank you. 

Wendy Fulwider: Questions? John.

Johan Foster: Amongst your grower base, ...

Christopher Ely: Yeah.

John Foster: ... how old are some of these? How long have these operations been in [inaudible]? 

Christopher Ely: Most of our base are older farms. Most are Amish and Mennonite farmers. So, 

their, they are, they are always have been practicing diversified farming. They are older 

buildings. And, so they struggle to keep up, and had struggled to keep up with the 

conventional business, because of this. To build a new barn today would cost close to 

half a million dollars. 

Wendy Fulwider: Calvin.

Calvin Walker: You mentioned that approximately 30% of organic grain growers have went out 

of business. [Inaudible]

Christopher Ely: No, I did not say go out of business. They have left the organic... 

Calvin Walker: What time frame? 

Christopher Ely: Within the last two or three years is the estimates when we asked, you know, 

where is the supply? If you know where, over two years ago or no, less than two years 

ago, for example, organic corn was about five dollars a bushel. It is now over $16 a 

bushel. Part of that is, is supply. They all went because it is easier to grow ethanol, you 

know, corn for ethanol. Make a lot more money. 

Wendy Fulwider: Alright, thank you. 

Christopher Ely: Good, thanks. 
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101

Barry Flamm: We will take a break now and returned at 3:45. 

[BREAK] 

Barry Flamm: Wendy, you can continue with the public comment part of your committee work. 

Wendy Fulwider: Michelle, could we have that slide back up? Okay, Michelle has the url here 

where you can go and see the question list that we have for the GMO vaccines. So that is 

available. It is on the website, on the NOP website. Okay, and Mel Gehman, you are up 

for public comment, and Dena Jones is on deck. 

Melvin Gehman: Good afternoon, members of the NOSB and the National Organic Program. I 

am Mel Gehman, represent, Mel Gehman of Heritage Poultry Management Services. 

Since 1997, we manage organic egg production, produced in Pennsylvania farms, and 

certified by PCO, packed for high-quality brands in the Northeast markets. I also serve on 

my second term on the Animal Health and Diagnostic Commission of Pennsylvania 

Department of Agriculture, as Chairman of Poultry Health Committee. PDA is a 

certified, a certifier of the PCAP Program for 21 years, which includes SE environmental 

testing, and inspection. 

I want to address the Livestock Committee’s agenda item, vaccine for excluded methods. 

Thanks for the Livestock Subcommittee for the delay. Thanks for your diligent efforts to 

understand these complicated issues. I think we need some scientific input on different 

types of gene, gene changes and vaccines and so on. So, I commend your efforts, and 

wish you the best in coming up with some ideas on how to handle this. 

We recommend that the decision on vaccines for excluded methods be postponed until 

there is clear, acceptable choices of live salmonella and E. coli vaccines available for our 

food safety commitment. Salmonella vaccination is a proactive, preventative program 

that is considered essential in well-regarded food safety programs, to name a few, the 

PCAP Program in Pennsylvania, FDA egg safety law and the Line Code Egg in Britain. 

And that is some potential export market, because they are very short on organic eggs in, 

in Europe at this time. 

Salmonella vaccination is a very vital component of an integrated management food 

safety program. Many egg farms may not experience or know of their experience of 

salmonella, unless they have a testing program. Salmonella can come into an organic egg 

flock by underground water supply or insects besides other well-known vectors. We need 

a good option for salmonella vaccination, and today, are, there are national and regional 

supermarkets that require vaccination, vaccinations. 

I am sorry, I ran out of time. I had a few pictures of organic farms in Pennsylvania that

have been on the Pennsylvania quality assurance program and tested since the late 90s, if 

there is any interest. 

Wendy Fulwider: Questions? Okay, thank you. Melissa Liszewski is on deck. 

Comment [JMS27]: 07:25:02

Comment [JMS28]: 07:51:40
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Dena Jones: What do you think, am I tall enough? Oh, now I feel really tall. I think I will go 

back down. [Laughing] Thank you, though.

I am Dena Jones with the Animal Welfare Institute and thank you for allowing me to 

comment on the guidance documents and the scorecards. Wendy, your introduction was 

very helpful. It did answer my, some of my questions. 

Before I talk about the guidance documents, though, I wanted to mention quickly the USEU equivalency agreement. As you know, the two partners have, trade partners have 

entered into an agreement on organic and animal welfare is one of the areas, it is where 

they differ quite a bit. There is no exception, as there is in the Canadian equivalency 

agreement for animal welfare, for stocking densities, or anything like that. So we feel that 

this is a disadvantage to the producers in the EU and some of the US producers that 

produce to a higher standard. So, we are not happy about the equivalency agreement on 

the basis of animal welfare.

As to the guidance documents and the scorecards, we still believe that the guidance 

should not replace regulations, and that some of what is in the guidance belongs in 

regulation. If a practice is to be prohibited, then that pro-, prohibition should be spelled 

out in regulation, not in guidance. 

The three guidances for sheep, bison and poultry are quite different and it is clear that 

they have been written by different people. And I know that you are aware of that. They 

cover different things. They address different kinds of issues. They are organized 

differently. The poultry guidances cover transport and slaughter, for example, while bison 

and sheep do not. The scientific justification for the guidances vary significantly. The 

bidance, bison guidance appears to be some sort of producer’s handbook with very few 

references, while the poultry contains 175 scientific references – that must be Sarah

Shield’s influence – and the sheep has no scientific references at all.

We support the use of scorecards, but not in isolation. So, in this case, we have guidances 

for poultry, bison and sheep, with no scorecards. And then we have scorecards for dairy 

with no guidance. We think that they should be done together and not in isolation. 

We thank the Livestock Committee for your work over the last few years. Know it has 

been difficult. You spent a lot of time on animal welfare. I think it does shows but we feel 

that a lot more does need to be done and that you are off to a good start but we want you 

to continue on and eventually reach your goal of being the gold standard for animal 

welfare and also closing the gap of the differences between the EU and the US. Thank 

you. 

Wendy Fulwider: Questions? Colehour.

Colehour Bondera: Thank you for your, for your testimony and I apologize if you are going to be 

repeating yourself a little bit. But, could you comment either a little further or start out by 
Meeting Of The National Organic Standards Board

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repeating what you said about the animal welfare issues as they relate to the agreement 

with the EU? 

Dena Jones: Right. 

Colehour Bondera: [Inaudible]

Dena Jones: Well, the Animal Welfare Institute did a side-by-side comparison of the US and the 

EU on animal welfare and there is dozens of major differences between the two. So, they 

are not close. When we entered into an agreement with Canada, Canada made an 

exception for stocking densities. That was an animal welfare issue. There is no exception 

here, and we feel that that puts some of the producers that produce animals, raise them to 

a higher welfare standard, puts them at a disadvantage. So there is many differences. We, 

and we, like I said, we have a side-by-side comparison if you are interested. 

Wendy Fulwider: Colehour.

Colehour Bondera: Sorry, just as a, as a follow-up to ask, maybe that is where I wanted you to 

give more information is you do feel like producers in, in both the United States and the 

European Union are, some of them are going be, some of the ones that are doing things at 

higher animal welfare standards are going to lose out by this agreement? Or could you be 

more specific? 

Dena Jones: Yeah, we believe that it puts the EU producers and some US producers at a 

disadvantage. So I am saying that basically all the EU producers are producing at more of 

a consistent standard than the US is. And that it is generally higher on animal welfare. So, 

it is a disadvantage to EU producers and some US producers that produce to a higher 

level. 

Wendy Fulwider: Did you submit the document you are referring to in your written [inaudible]? 

Dena Jones: No, but I have it with me and I can. I can... Can I hand it to you right now? 

Wendy Fulwider: That would be fine, thank you. And, Hanna Whitehead would be on deck.

Unknown Male: Thank you.

Melissa Liszewski: I am Melissa Liszewski with the Animal Welfare Institute. And first of all, I 

would like to thank the NOSB for allowing me to comment on the proposed species 

specific guidance documents today. Oh, thank you. 

While AWI appreciates the NOSB' s continued efforts to address the lack of animal 

welfare standards under the NOP, these guidance documents must be strengthened in 

order to better assure that animals are well cared for and that the organic community 

maintains focus on making truly continuous improvement. A few of the areas in need of 

strengthening are as follows. 

Comment [JMS29]: 08:00:00
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First of all, with the ammonia level: If USDA organic wishes to have higher animal 

welfare standards than the conventional industry, then guidance should state that 

ammonia levels in poultry housing be less than 10 ppm and action must be taken if the 

level is more than 15 ppm. The current proposal that ammonia levels should be less than 

10 ppm and must be at or below 25 ppm is too weak. 

For space allowances for poultry: Minimum indoor and outdoor space allowances should 

be increased for chickens, turkeys, geese and ducks. Although the space allowances were 

increased during the last NOSB, NOSB meeting, they are still too low. 

For catching and carrying: Standards should be set requiring that all birds be carried by 

both legs and not by the neck, wing or a single leg. Also, birds should be caught in low 

light situations and no more than three birds should be carried per hand. 

For method of stunning and killing: Guidance should discourage killing poultry without 

stunning, and recommend gas stunning over electric to avoid removal from transport 

crates, shackling and inverting of live birds.

For euthanasia: Acceptable methods of euthanasia for both sheep and bison should be 

specified or reference made to the international OIE guidelines. 

AWI encourages the Livestock Committee to strengthen these guidance documents for 

poultry, sheep and bison to increase animal welfare and to help bring the care of animals 

under the organic program closer to what consumers expect of the label. Thank you very 

much for your time and consideration. 

Wendy Fulwider: Okay. We have a comment, question, here. Mac.

Mac Stone: I see on your list, you are talking about force-feeding in foie gras.

Melissa Liszewski: Mmm-hum. 

Mac Stone: There are several public comments that came to Livestock Committee, and I guess in 

consultation with other Board members, we felt that, you know, it would not be allowed 

in organic if it is not a natural situation and do not know of any certifiers that certify that.

Melissa Liszewski: Mmm-hum.

Mac Stone: But in general, it would not be allowed in organic just [inaudible].

Melissa Liszewski: Mmm-hum. Okay, thank you. Yes, we, we did look into this issue, and we 

just felt that it might be something that would be clar-, it would be helpful to be clarified 

in the guidance document or in the standards, because we did many searches for organic 

foie gras products. And although we were not able to find any with the USDA organic 

seal, there was a lot of misleading products for sale on different organic food websites, 
Meeting Of The National Organic Standards Board

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105

gourmet food websites, that made it appear that it was an organic product. Although, 

when I look at the packaging an actual picture, I did not see the USDA organic seal. So as 

further clarification to help consumers, it might be helpful to just have this stated 

outright. 

Wendy Fulwider: Okay, thank you. 

Melissa Liszewski: Thank you.

Wendy Fulwider: Suzanne McMillan is on deck. 

Hannah Whitehead: Hello, my name is Hannah Whitehead. I worked on an organic urban farm in 

Chicago. I have worked on organic farms through Worldwide Workers of Organic Farms 

in Europe, and right now I am volunteering at Nancy's organic goat dairy, Nancy 

Coonridge’s organic goat dairy here in New Mexico. I am here today as a citizen 

lobbyist, testifying on behalf of the Cornucopia Institute. 

I want to reiterate what Nancy said about how the recommendations do not meet the 

expectations of organic consumers and place ethical family farmers who adhere to the 

spirit of organic standards at a competitive disadvantage. I want to talk a little bit more 

about the chickens and the outdoor space allotted which is an embarrassment, compared 

with European standards, which require 43 square feet, with no more than 3,000 birds per 

building. In the US, the organic brand with the largest number of farmer suppliers, 

Organic Valley, has proven that five square feet outdoors is commercially viable for egg

production. Two square feet outdoors also deprives chickens of the ability to exhibit their 

natural behaviors in an outdoor environment, which is part of the organic regulations. 

Chickens like to sort of run around and flap and forage everywhere, like you know and 

like we see all over at Nancy’s farm. And chickens with only two square feet clearly do 

not have the ability to do any of that. 

Also I want to reiterate what she was saying about the limits on ammonia levels in 

poultry houses which should be lowered and the confusion about 20 ppm and 25 ppm 

should be clarified. 

There must also be a minimum age of slaughter for chickens to make sure that the 

practice of choosing unhealthy breeds that grow too quickly, which happens in 

conventional poultry in the conventional poultry industry, does not happen in organics. 

The only way to ensure that animal welfare standards are met is to create... to ensure that 

animal welfare standards are met is to create standards that are meaningful and, and

enforceable, as others have said. So, we urge the Livestock Committee to focus its energy 

and resources on strengthening these standards. Thank you. 

Wendy Fulwider: Questions? Calvin.

Calvin Walker: You mentioned you had some experience in Europe? 
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106

Hannah Whitehead: Yeah.

Calvin Walker: Can you share with us maybe one or two differences that you see as it relates to 

animal welfare? 

Hannah Whitehead: I guess it is hard for me to say because here I am working also on an organic 

farm that adheres not only to the regulations, but very much to the spirit of, of organic. So 

I see a lot more similarities than differences. So, unfortunately, I do not know. Yeah.

Wendy Fulwider: Thank you. Trey Reish is on deck. 

Suzanne McMillan: Hi. My name is Suzanne McMillan. I am director of Farm Animal Welfare 

for the ASPCA. By virtue of being alive and sentient, farm animals pose unique 

challenges for the organic sector, which crop and other inanimate commodities do not. 

The recent US-EU equivalency agreement makes it all the more timely and urgent that 

we address animal welfare concerns. Our written comments address five areas, and I, I

will touch on each briefly.

First, the topic of space: Stocking densities should allow for animals’ natural movements 

and behaviors. All too often, this is not the case. Frequently, birds are unable to engage in 

even the most basic comforts, which they desperately crave, such as spreading their 

wings, foraging, and dust bathing. Providing adequate space also supports physical 

health, such as leg health and undisturbed sleep. NOSB’s recommendations are a strong 

first step in the right direction, but fall short in certain key areas which we have outlined 

in our submissions to you all. 

Secondly, the topic of ammonia: Birds who are housed predominantly indoors, such as 

organic rules currently do allow, generally live with their own droppings. Which in turn, 

generate ammonia, which has the effect of irritating eyes and respiratory tracts. And so, 

we are asking you for please lower the allowable level of ammonia to 10 ppm. 

On the topic of beak trimming: Thank you for recognizing that the perceived need to

beak trim is in fact tied to numerous industry created underlying factors, such as using 

breeds prone to pecking, providing inadequate space for birds, lack of enrichment for 

these birds, offering an improper diet, and other factors. As a result, birds experience 

stress and exhibit misdirected pecking behavior. Therefore, farms should be made to 

address these underlying factors, rather than allow it to simply mask the real problem by 

perpetuating its underlying causes.

On the topic of forced feeding: Forced feeding is not covered, currently, by NOSB

recommendations or proposed guidance, expressly covered. But, is it, we feel it is an 

important topic to address because there is an active foie gras industry in the US in which 

ducks and potentially geese are or will be force-fed and this is particularly a cruel and 

controversial practice. The EU does expressly bar force-feeding in organics, and the 

reality is that the current poultry industry rules here argue, arguably would allow it. 
Meeting Of The National Organic Standards Board

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107

And, on the last topic, slow-growing breeds: Thank you so much for recognizing that this 

is a key issue of bird welfare. The broiler and turkey industries have for some time now

relied on fast-growing breeds, decreasing the time that it takes to get them up to slaughter 

weight. The combination of fast growth and excessive growth creates physical 

complications when their skeletons simply cannot match with the excessive breast 

musculature, resulting in horrendous and frankly avoidable suffering for these birds, 

including leg abnormalities, severe problems with locomotion, often chronic pain, bone, 

joint, and tendon problems. Thank you very much. 

Wendy Fulwider: Questions? Okay, thank you. 

Suzanne McMillan: Thank you.

Wendy Fulwider: Leah Garces on deck. 

Trey Reish: My name is Trey Reish and I want to thank you for letting me speak. I work for 

Veterinary Service Inc. in, in the West Coast and we distribute animal health products. 

My job mainly is poultry vaccine. 

I was going to say a lot of other things, but I think I want to try and clarify what the 

salmonella vaccines are. There are two types of vaccines, there is live and there is killed. 

The killed is not what you guys are talking about. The live is the GMO. There are three 

companies that produce them, Lohmann Animal Health, Pfizer, and CEVA. Their, the

names of those vaccines are MEGANEG or MEGAVAC, Poulvac ST, and SALMUNE. 

On the West Coast, and I believe here I think there is something, the recommended 

application of these vaccines are two lives and one killed. The first one is given around in 

the first week of age, then six weeks, and then somewhere between 11 and 14 weeks.

And the purpose to do it in that manner is, the live vaccines are not a booster, or not a 

primer for the killed. What the live vaccines do is they protect the bird during that grow 

period up to 11 to 13, 14 weeks. And then you give them the killed, which gives them 

protection that carries them out for the rest of their lives. So, it is real important that you 

do that. 

The application of the two vaccines, the live vaccine, which is the GMO – let us get that 

clear, live is GMO, there is no company out there, there is no company out there making 

a vaccine that is not a GMO that is not a live. He is making the same vaccine as the killed

that all the companies have. The application of the live is done through the water or 

spray. And again, it is done at an, at an early age, somewhere around six, one day, one 

week of age, some out to six weeks we do the second one. Then you come in with the 

killed, and that is an injection. And that is the only way it can be given. 

Thank you. I am, I got it. Any questions?

Wendy Fulwider: Questions? Thank you. 
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108

Nick Maravell: I, I...

Wendy Fulwider: Nick. [Laugh]

Unknown Male: Jay [inaudible].

Barry Flamm: Jay has a question.

Nick Maravaell: Is there a, is there a reason that the inactivated or killed bacteria cannot be used 

in the earlier stages of development, in terms of the health and the growth of the animal? 

Trey Reish: I cannot give you a specific reason, except one: that the chicken is probably too 

small to accept that injection. A vet could answer that question very clearly. But, I used 

to, I have been in poultry industry for 35 years, and the chicken is probably just too small 

to take that volume of a... There is a adjuvant that is put into, and it is an oil, that is put 

into the chicken with the vaccine and it spreads out there and it stays there for a long time 

and continues to give protection. And the, the salmonella vaccine that they are giving at, 

at 14 weeks, it is usually a combination with the Newcastle, which is a virus, and a 

bronchitis, which is a virus, and the salmonella, which is a bacteria. 

Nick Maravell: You say you have been in the industry about 35 years? 

Trey Reish: Yeah. 

Nick Maravell: What happened 35 years ago? That was about, well, roughly the time that GMO

vaccines were first developed. Not for, not for birds but. What, what occurred back 35 

years ago? 

Trey Reish: The GMOs really, in my experience, have probably been in the last 10 years.

Nick Maravaell: Mmm-hum.

Trey Reish: And, other than salmonella, there is a, a gene inserted vaccine, where they take the 

Marek’s vaccine, which every chicken gets a day of age, and they insert a gene from 

Newcastle, bronchitis – something else [inaudible] – oh, IBD, infectious bursal disease, 

and they insert it into the, the cell, or the, the cell of the Marek’s Disease. The chicken 

sees that without the actual virus being present, and if there is an attack of that disease on 

that bird, the bird has protection to fight off that. And, the, why this technology is, is so

needs to really be looked at is because there are a lot of diseases out there. And I am from 

Southern California, and we have a bunch. And all the farms are close around. Is that if

you use this vaccine, and it is successful, the virus is not there. If you continue to use a 

live virus to treat your diseases, which is what we are doing now, you continue to keep 

the virus going. You keep it at a low level. But it continues to, it continues there. If you 

were to use the gene inserted, and it is successful, and this is new technology, you may be 

able to eliminate the disease or you might not have to vaccinate. 

Comment [JMS30]: 08:15:00
Meeting Of The National Organic Standards Board

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109

Nick Maravell: The gene inserted, I assume, would be considered a biotechnology method or an 

excluded method or a GMO method. 

Trey Reish: Yes. Yes. It is GMO.

Nick Maravell: But, but are you saying that you would not have any virulence in that, from that

gene? 

Trey Reish: No.

Nick Maravell: Right. So, you have attenuated, you have deactivated that?

Trey Reish: You put it there, and it only seems to appear when it is needed, because it is being 

attacked. The body has some memory there, like, hey, I have seen this one before. I can 

go after it. 

Nick Maravell: But what occurred before you have this technology in the poultry industry? 

Trey Reish: Live vaccines. 

Nick Maravell: Live. So, so live vaccines, live vaccines prior to using GM, GMO methods to 

inactivate them?

Trey Reish: In my experience, the GMOs have only been out for about the last eight years, 10 

years. 

Nick Maravell: Right. 

Trey Reish: Okay. So what is your question?

Nick Maravell: Well, what did, what did, what happened in the poultry industry 30 years ago 

with regard to vaccination before there was the GMO technology and the current live 

vaccines? 

Trey Reish: We just, we dealt with each vaccine, the man who did the autogenous, there was a 

number of people who made their own vaccines. They would take their own bug and they 

would make their own in the bathtub and try it. And that is how technology has grown. 

The vaccines companies came in and they have made theirs, you know, the, there is four 

major ones. That man mentioned the Merial, and I did not mention that one earlier. And 

they just kind of kept up with technol-, or the needs of the farmer, as the disease became 

a problem. Probably, I am going to guess 20 years ago, we did not have any vaccine for 

MG, Mycoplasma galla-, galiseptium [gallisepticum]. And that is one that plagues us 

now, and we have a vaccine for it and it, it works very well. So, as these disease, diseases 

appear, the companies make their vaccines for them. But, generally, most vaccines over 
Meeting Of The National Organic Standards Board

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110

the last 35 years have been live, and this, this technology is, it is, it is an attempt to try 

and get rid of the diseases themselves. 

Nick Maravell: But, in, in the past eight to 10 years, have you seen that actually occurring with 

salmonella, for example? [Inaudible]

Trey Reish: Salmonella is not the gene inserted, it is gene deleted. And the reason, the reason for 

that is, you are not, you want, you do not want to take salmonella and put it out there, 

even though Europe has a vaccine that does that. They put it out there, and it is 

salmonella typherium [typhimurium], they gene delete it so it cannot become active. And 

that is the purpose of the gene deleted. Lohmann and Pfizer have gene deleted and CEVA 

Biomune has a chemical deleted. Any other questions? 

Wendy Fulwider: Jay.

Jay Feldman: Thank you. Of your vaccine suppliers, can you determine which materials are 

GMO? 

Trey Reish: Yeah. 

Jay Feldman: Is that through labeling? Or how do, how do you make that determination? Just 

based on this formula of live versus killed? 

Trey Reish: No. In the sales of the vaccine, I am around the vets all the time. And it is a topic 

that we bring up all the time. Is this one a GMO? And generally, most of the HVT, the 

herpes virus vaccines, that have the insert, so when you see the HVT vaccine on a 

vaccination schedule and then you see a secondary disease there, like HVT-IBD, which is 

Infectious Bursal Disease, HVT-ND, which is Newcastle, HVT-LT, which is 

Laryngotracheitis. That one is inserted, and those are all GMO. And then, the salmonella, 

the ST, salmonella typherium [typhimurium?], is a gene deleted, not gene inserted. 

Jay Feldman: Are you dealing with the universe of vaccines? Or, you are West, West Coastbased, right? [Inaudible]

Trey Reish: I deal with all the major manufacturers. I sell whatever the customers are looking 

for.

Jay Feldman: So, you know, in your view, would it be difficult to transfer the information you 

have to the, to the farm community or to the certifier community? 

Trey Reish: That, that is what I do. Oh, to the certifying community? Yes, I can get that done. 

And I can, I can put you in touch with people who can explain, like the question I said 

you need to ask a vet that, of how it is actually done.

Jay Feldman: Thank you.
Meeting Of The National Organic Standards Board

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111

Trey Reish: Because all of my information comes from sitting on the sidelines and listening to 

vets explain, ...

Jay Feldman: Right.

Trey Reish: ... explain how their, their vaccine works. And, and when they have difficulties, you 

know. We do not only, only vaccinate for, to prevent. Sometimes we vaccinate to put 

down a, an outbreak. 

Jay Feldman: Thank you. 

Trey Reish: Thank you very much. 

Wendy Fulwider: Thank you. David Will on deck. 

Leah Garces: Hello, and thank you for this opportunity, and also for your very hard work to date 

on these standards. I know it has been a difficult process. By way of background, 

Compassion in World Farming is headquartered in the UK, but we have a US presence in 

Atlanta. And throughout our 50 year history, we have been integral to banning some of 

the cruelest confinement systems throughout the EU. And we have also provided 

comments and guidance to the EU organic standards and continue to provide those 

comments. And we work to end factory farming globally. 

We appreciate the efforts that have been done to date, and of you, as you have heard with 

some of the other comments, we are deeply concerned with regard to the recent 

equivalency agreement between the EU and the USA regarding the organic standards. 

And there are some very significant differences between the EU and the US organic 

standards, with regard to farm animal welfare. And, I would like to talk about some of 

those today and answer any of your questions that you might have. 

We have been working in the EU with the organic community to raise our concerns with 

the commission to this regard, because we strongly disagree that these are equivalent 

standards at this stage. We have had press and consumer interest in the EU. But, we also 

have been emphasizing the wonderful opportunity we have here, to have the US organic 

standards rise to the potential of meeting, to be truly equivalent to the EU. I have 

submitted lengthy comments, some of which outline the differences between the EU and 

the US, which you have received. But, I would like to talk, highlight a few of them that 

have concerned consumers in the EU and, of course, will be highlighted when this 

equivalency agreement comes into effect on the first of June. 

One of them is on water for swimming for ducks and geese. This has been mentioned

already. But, the EU organic standards says as follows: water fowl shall have access to 

stream, pond, lake, or a pool whenever the weather and hygienic conditions permit, 

permit in order to respect their species specific needs and animal welfare requirements; 

where the US organic standards just require dipping their heads or splashing their 

feathers, which could be accomplished through a small trough. 
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112

The other big one for us is the minimum space allowance. Now, I know that we discussed 

this at the last meeting, but they are still too low. We have discussed that the EU have, 

has an outdoor requirement of 43 feet squared per bird, and we are talking about two 

here. That is not equivalent.

And there were other issues which are not addressed to date, which are, for example, 

there is no minimum space allowance for pigs, and there is extensively written space 

allowances for pigs in the EU, and for all species for that matter. 

So, electric prods are also expressly prohibited in the EU and they are not in US 

standards. 

So we respectfully urge you to incorporate the standards that have already submitted and 

continue your hard work to have the US organic standards rise to the potential of what 

consumers expect in the spirit of organic. Thank you. 

Wendy Fulwider: Questions? Thank you. David Bruce on deck. 

David Will: Ready, set, I have this timed. Go. 

Hi. My name is David Will. I am with Chino Valley Ranchers. I also sit on the California 

State Organic Program Board. And I am the newly appointed Chairman of the brand-new 

United Egg Producers Organic Group. My comments are based solely on our, my 

position as general manager of Chino Valley Ranchers. We are organic egg producers in 

California. 

I wanted to thank the Board very much for the work that they have done so far on the 

standards, and just wanted to bring up one minor concern that we have as being one of 

the few organic producers that molt our organic laying hens. We found that the standard 

does not match what already is in existence by Animal Certified Humane, the United Egg 

Producers program, or the Humane Animal Certified program. You do not take into 

account the fact that when a bird goes into molt, that its nutritional needs have changed 

and that comparing the ration consumed during the life of a bird during its egg laying 

phase versus in molt, there is definitely a different nutritional requirement and therefore, 

the feed requirement would be different. 

Second, we support the change proposed by the Methionine Task Force. I know that is 

not up for this Board meeting, but we did want to let you know that we do support the 

change to the 2 pound cap over the life average of the bird, not a 2 pound cap per ton of 

feed. Because as different age of birds, they do have a different nutritional requirement, 

and capping us does not allow us to adjust for that specific need. Also, there is many 

times at the end of a bird’s life that the 2 pounds is woefully over feeding, and we would

like to be able to have it based on science. 
Meeting Of The National Organic Standards Board

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113

Also, I have one concern with the, the language in the GMO vaccine about requesting 

that a state organization, perhaps, be the one to declare an emergency for the use of GMO

vaccines. I would like you to please look at the written comment that was submitted by 

the California Farm Bureau Federation where they do address the fact that they do not

think a state organization or a federal government would be as not in the practice or 

practical for them to declare a state of emergency, and that states would be reluctant to 

declare states of emergency.

Also, I wanted to point out that we do use two live and one killed SE vaccine. We do that 

solely due to the demand of customers. Also, the, our vets have required it. After the 

outbreak of 2010, I cannot tell you the number of phone calls from retail chains that we 

got, including one of the largest natural food chains that has 300 locations worldwide, 

making sure that we are using live and killed vaccine because at the time, it was a very 

hot button with the introduction of the FDA egg safety rule, at the same time as that 2010 

outbreak. 

Also, just know that of the last three salmonella outbreaks that have occurred, two were 

on organic farms. Coming from California, we are proud members of the California Egg

Quality Assurance Program, and that program has been in existence since the early 90s 

and strongly supports the use of the two live and the one killed vaccine for our state. 

[Sigh]

Wendy Fulwider: Questions? Thank you. 

David Will: Thank you. 

Wendy Fulwider: David Bruce? Woodie Williams on deck. 

David Bruce: Okay. Good afternoon, everybody. My name is David Bruce. I work for Crop 

Cooperative, which markets under the Organic Valley and the Organic Prairie label. I 

direct the juice, eggs, meat, produce, and soy pools. I am also President of the Organic 

Egg Farmers of America, which is a affiliation of about 40 farmers from small to large 

and industry affiliates and certifiers that have come together to have educational events, 

to do research, to talk about issues that we hold in common that we all need to learn 

about. And all, obviously, this is one of those, too. And then I am also on the Methionine

Task Force as well. 

First off, in terms of the GMO vaccine issue, I would say clearly and loudly that I am not 

a, a GMO, or a vaccine expert by any means. But, I hear from my producers all the time 

about how important this is in their toolbox for organic layer hens. There are not very 

many options in terms of treating diseases and so clearly this is something that needs to 

be very, very well understood before we move forward on recommendation for organic 

producers, particularly in terms of the, as other people have said, in terms of the FDA

salmonella rule. It is just a really hard time to be looking at taking that tool away from the 

producers. We also follow the two live and one killed vaccine regime, both from 

customer standpoint and just because our veterinarians are, are advising that. And so, 

Comment [JMS31]: 08:30:00
Meeting Of The National Organic Standards Board

May 23, 2012

114

until we truly understand, I mean, obviously there is a lot of expertise in this room, and 

what I had heard was that we could not necessarily gather the true information. So I think 

if we come together, I think OTA has done a tremendous job in their comments and, and

in terms of the research that was done there, and so I would really endorse that

recommendation, that we form a task force working with USDA and the industry to try to 

address those things. So we are happy to be involved, if we can. 

In terms of the animal welfare for organic layers, I personally feel like we really are on a 

slippery slope here with having such long detailed analytical documents to work off of. I 

understand that this is a discussion document, but, you know, it seems like it had not been 

well reviewed by the committee or the NOSB as a whole since the density requirements 

were not the same as what had just been put forward. It seems like it is one particular 

view, one author's view of these issues and that it ought to be vetted through the 

community so that it repre-, represents all sorts of different production models. And so, I, 

I just feel like, obviously the step from discussion documents to guidance to proposals. 

And we all know that we are dealing with livestock inspectors on the ground that are not 

necessarily well-trained for the current things they are doing. And so to add this layer of 

expectation that they are going to be suddenly able to score hens, which is not, you know, 

it is difficult for anybody, really depends on the breed and the stage of life and the 

conditions that they are in. So, I think that while I agree that we need to incorporate these 

kind of things, we need to get down to a bullet points and something that is really, truly 

something that can be used in the field and is applicable. 

In terms of the Methionine Task Force, I would just echo too what has been said already. 

You know we really appreciate that the rule came out and has been put into place. We are 

all talk, tired of talking about methionine. But, we know that the, the levels that were put 

forward came from the step down rates which were not responded to by the last NOSB or 

two NOSBs ago, or I forget how long ago. So, we would really request that the petition 

on the table be picked up and dealt with. We put it in in terms, we put it in in time to be 

dealt with at the fall meeting, and while I believe that perhaps we might be able to get 

away with 2 pounds average for layers, I am really concerned about broilers and turkeys, 

in particular, because of ammonia issues, health issues in regard to that. So thank you.

Wendy Fulwider; Questions? Thank you. Please come up. 

Woodie Williams: I am going to make a few comments, which I hope I can deduct from my real 

comments. This is my first time at a NOSB meeting, and I will have to say, it is rather 

illuminating. I come from an academic background, a professor of nutrition department 

head, and really have been in the consulting business, international consulting in poultry, 

etc. for some 30, 40 years. And I have followed the organic situation quite well from a 

nutrition standpoint. And, I just want to make a few comments today, basically pertaining 

to methionine. 

Most of us look at methionine as being an amino acid, just an amino acid. But, it is

unique among the amino acids. And we need to, need to remember that, because, the 

methionine issue is not only a nutritional issue, it is an animal welfare issue. Because, 
Meeting Of The National Organic Standards Board

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115

methionine is one of the amino acids, that if it is deficit for any period of time, the birds 

may begin to loose feathers, they begin to become cannibalistic, and you can have a real 

mortality issue. Now I say that in preference to, to saying, well, it is a, it is a critical 

issue. And, understand it is from a nutritional issue, and it is a animal welfare issue. If 

you have never seen a group of birds which have been deficit from methionine for a 

period of time, you have not seen a real animal welfare issue. So my comments today 

relate to how do we prevent this, and how we make it possible for producers to, to

enhance their performance.

Now, in the issue which I have put forth in the pamphlet, most of us in my case, we 

recommend multiple phases of feeding. We fix, we feed six phases to laying hens, 

organic or non-organic. Which means that in the case of methionine supplementation, as 

you will see in the handout, then initially, for example, that if you assume a bird is eating 

a given amount of feed, we put a given amount of methionine in, or amino acids like 

lysine or arginine or tryptophan, or any the others. 

So what I urge you to do, basically, is to look at it from the standpoint that in phase one, 

we need about 3 pounds. In the phase six, we only need about less than 0.9 pounds. So, 

you see if you will average this – excuse me – if you will average this over the life of the 

bird, we can live with two, two and a half pounds. But, if you do not give us some help, 

the growers on the front end when we need maybe two, three pounds, we will have a 

problem. We will have a serious problem on our hands, and it is, it will be caused by a 

nutritional issue becoming a animal welfare unit. Thank you. If you read the documents, I 

think you will see a little more of what I am, what I am saying and it will be passed 

around to you. Any questions? 

Wendy Fulwider: Jay.

Jay Feldman: Can you tell us what the natural forms of methionine are in the diet, or could be in 

the diet? 

Woodie Williams: Natural forms would come in from any ingredient. You see, in the US, and I 

have had experience in Europe for organic feed, we rely upon soybean meal as our 

principal source of protein. It happens to be very good in lysine but very low in 

methionine.

So in Europe, though, they do not have the same problem. I have formulated some feeds 

for Europe for organics. It is a, it is a different problem, where we do not have a lot of 

ingredients that are high in methionine, except for maybe, say, fish meal, and some others 

that are not very abundant. And I certainly would, would not have liked to have been 

dependent upon fish meal when we had the oil spill in the Gulf of Mexico. That would 

have been a disaster for the organic people relying upon fish meal or something of this 

nature and have such a, such a dependency. 

So, we get it from corn. We can get it from wheat. We can get it from alfalfa. We can get 

some from soybean meal. But basically, other than that, from a distributor's standpoint, 
Meeting Of The National Organic Standards Board

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116

you do not have much alternative. Lysine is not a problem. Why? Because soybean meal

has a lot of lysine in it, so we do not worry about that. Europe has to worry about lysine, 

you know, because the difference in ingredients. 

This is what, sometimes I think, we forget that we talk about what Europe is doing and 

what we are doing. We do it different because we have different things to work with.

Jay Feldman: Thank you. 

Jennifer Taylor: [Indiscernible-low volume] through pasture, pasture management?

Woodie Williams: Minimal. Grasses are very, very low in methionine as such. It is very 

minimal. So you cannot do much to correct that from a natural grazing standpoint. So, 

we, we have some products, like, that may be high in methionine, or high-er. Meat meal, 

but we cannot use it in organic, see. So we are limited what ingredients are produced in 

the US that are organic certified that have any cornmeal methionine in them. So I do not

know, I would be real honest with you. Down a few years from now what is going to 

happen if we take methionine out. I just do not know. Unless we have an abundance of 

other ingredients coming along, it is going to pose a real problem. Let us just face it. It is

not going to be an easy, easy thing to settle in the US. Much easier settled in Europe, 

because we have done most of it in Europe. But, the US is quite different in feed 

ingredients. They do not want soy. Why do not they want soy? They have to bring it in. 

They do not want to import it. So, they go another way. So, it is, it is really interesting to 

watch it worldwide. That is what I am saying. 

Wendy Fulwider: What about all the research that is being done on other alternative sources of 

methionine?

Woodie Williams: Well, I, I have to say this. I do not give it much, much hope. A lot of work 

went on with corn, for example, breeding more corn. Well, they could breed a little bit 

more protein, but methionine in relation to protein did not change. So, that really was not 

much of a fruitful effort. And it is a long-term thing. Plant genetics is a very, very longterm thing, unless we can get some soybean meal, which has a lot of methionine.

Wendy Fulwider: Any other alternatives? 

Woodie Williams: I do not see it. And I have worked with this thing for 10 years, and unless we 

can do some importing from Europe. 

Wendy Fulwider: All right, thank you. Based on all the public comments we have received 

today, we, the Livestock Subcommittee has come up with a proposal that Nick would like 

to share.

Nick Maravell: Well, I just, whoop, I just sent it to the Livestock Committee. I do not know how 

quickly the..., oh, it just went, how quickly. And Miles, you have a copy of it, too. This 

is a draft. 
Meeting Of The National Organic Standards Board

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117

Let me explain a little bit about what, what the Livestock Committee would like to do on

the GMO vaccine issue. We would like to work cooperatively with the Department to 

come up with what we have heard from the public are some vital first steps before we can 

move forward with the final formulation of policy. And the first step is clearly identifying 

the list of current vaccines as to their GMO content and then the second part, that we are 

proposing is that as we speak, any new registered vaccines either be labeled or there 

would be a tracking system that is publicly available. So, the list would automatically 

update. We need to know what are we talking about first.

So, I would like to propose a, a resolution in draft form that can be considered by the 

public, if, if we have an opportunity for additional comment, and by the Program, that the 

Board could vote on as its sense of, of the Board, as to what we need to do in order to go 

forward. And, we vitally need better information. There is no question about it. 

So, I can, let me see if I can find it now, I can. Would you like me to read that even 

though...? Or, or I do not know that it can be, if it could be put up on the screen. Can 

you...

Unknown Male: [Inaudible]

Unknown Female: You can send it to Michelle.

Nick Maravell: All right. I can cut through the introduction and the conclusion and just read two 

or three key sentences in the middle. What we are requesting is that USDA require 

livestock vaccines be labeled when they contain GMOs or were developed using GMO

techniques, or, USDA have a real-time, publicly accessible tracking system to identify 

GMO vaccines as they are registered. And, (2) APHIS or other appropriate USDA

agencies identify which currently available livestock vaccines are GMO, so that the 

NOSB, organic livestock producers, and organic certifiers can make informed decisions. 

That is the essence of what we, we are requesting. We are requesting the information that 

we do not feel we have solid ground on right now. And so, I guess -- oh, is it up on...? 

Okay, it is up on, on the board. 

We are further asking that at our October and our spring 2013 meeting, that any 

information that can be shared on this issue continue to be shared on this issue if we are 

making progress towards answering, for example, those two items. 

And we have also attached a list of, and I do not know if I, I do not have the attachment 

on this particular one. We have also attached a list of questions that we have collected 

from the public, from the Program, and from our review of the TR and our deliberation. 

If there is a way to also address those questions, we would love to work with the 

Department in discussing what the possibilities are for answering those questions. 
Meeting Of The National Organic Standards Board

May 23, 2012

118

But, the two essential ones we have outlined in the body of the text. And, we feel it is, it 

is responsible and fair to collect this information, make it publicly available, and have 

everybody able to then weigh in on the subject, based upon what we actually know. 

Melissa Bailey: Zea? We are, the, we are wondering, you know, how you feel about this or what 

you think about this proposal. 

Zea Sonnabend: I think it would be good to work in conjunction with Livestock to look at these 

issues. But, [sigh] the GMO aspects of it are not necessarily the same as like an em-, if 

you decide to go towards an emergency declaration language, like some people suggested 

or whatever. So, I did not receive it in writing, so I, and I was sort of half involved in 

paying attention when you were talking, Nick. 

Nick Maravell: I did not send it to, I was, I thought we were... I thought first to consult with the 

Livestock Committee before we but, but we can go ahead and do it with, and send it to 

everybody.

Zea Sonnabend: You know, the GMO task force would be happy to take a look at anything, you 

know, new coming up. 

Nick Maravell: Right. What we are, what we are proposing here, and this does not cut across 

committee areas, what we are looking here is to get a sense of the Board resolution.

Zea Sonnabend: Oh.

Nick Maravell: That this is where we want to go. And, we would, would appreciate if the 

Program would like to respond now to any comments that the Program have. We are 

looking to work together and, and get the information we feel is necessary to respond to

the issue raised by the Program. 

Miles McEvoy: Yeah, thanks, thanks a lot for this. We just got it, so it is going to take us a little 

while to look at it and see what the meaning is. And the Board as well is just getting this 

proposal. We can take another, we can look at it and get back to you on Friday with any 

particular comments. 

A lot of really good information was shared here today, we have also had a lot of 

assistance from APHIS in terms of them providing information over the last few weeks. 

They are very willing to engage and help out as much as they can with information. So, it 

seems like there is a, a lot of really good information that just needs to be assembled. 

What is the best mechanism to make that happen? I think we can work very closely with 

the Livestock Committee to see how we can move this issue forward, if that is just a 

matter of working with our, our sister agencies to get that information, getting the 

Livestock Committee more closely connected with APHIS in providing their, their

expertise on this, with, you know, other industry experts on this particular issue, we have 

just got to assemble this information. 

Comment [JMS32]: 08:45:00
Meeting Of The National Organic Standards Board

May 23, 2012

119

The concept of the task force, potentially, to address this, to take some of the burden off 

of the Livestock Committee's to assemble some of this information might be a way to go 

as well. So we look forward to working with the Livestock Committee on resolving this 

issue. 

Barry Flamm: Wendy, I suggest that the Livestock Committee distribute the written form of this 

and we will, I suggest we add this to the agenda. We have two, two different 

opportunities to put this on the agenda on Friday, and we will see if we have a resolution 

then. And, and I, either under new business, or under the area of differed voting. Either 

one of those, depending on the, if we have enough time under deferred voting, we can put 

it there. Otherwise, put it under new business. This is a proposed change to the agenda. 

And without objection, we will, we will change the agenda. Please, please distribute that

to all the members of the Board. 

Nick Maravell: Wendy, I am going to try to do that right now. We will see if I [inaudible]. If I 

could type, it would help.

Barry Flamm: This completes the agenda for today. We are in recess until tomorrow morning at 

8:00. Have a good evening. 

[Event Concluded] (End)

Comment [JMS33]: 08:50:19
Meeting Of The National Organic Standards Board

May 24, 2012

1

United States Department of Agriculture

Agriculture Marketing Service (AMS)

National Organic Program (NOP)

Meeting Of The National Organic Standards Board (NOSB)

May 24, 2012

Hotel Albuquerque Old Town

800 Rio Grande Boulevard NW 

Albuquerque, NM 87104

The National Organic Standards Board convened at 8:00 a.m. with Barry Flamm, Chairperson, 

presiding.

Members Present

Barry Flamm, Chairperson

Harold Austin

Carmela Beck

Colehour Bondera

Joe Dickson

Tracy Favre

Jay Feldman

John Foster

Wendy Fulwider

Nick Maravell

Jean Richardson

Zea Sonnabend

Robert “Mac” Stone

Jennifer Taylor

Calvin Reuben Walker 

National Organic Program Staff

Miles McEvoy, Deputy Administrator

Melissa Bailey, Director, Standards Division

Dr. Lisa Brines, National List Manager

Emily Brown-Rosen, Agricultural Marketing Specialist, Standards Division

Michelle Arsenault, NOS Advisory Board Specialist

**Please note that this transcript may contain errors or omissions and does not represent an 

official record of all proceedings that took place on May 24. Please refer to the live webcast for a 

more accurate representation of the meeting.
Meeting Of The National Organic Standards Board

May 24, 2012

2

TABLE OF CONTENTS

PAGE

Policy Development Committee ...................................................................................... 3

Break.............................................................................................................................. 36

Policy Development Committee (continued) ................................................................. 36

Handling Committee ...................................................................................................... 36

Lunch............................................................................................................................. 69

Handling Committee (continued)................................................................................... 69

Break............................................................................................................................ 104

Handling Committee (continued)................................................................................. 104
Meeting Of The National Organic Standards Board

May 24, 2012

3

Barry Flamm: Take their seats. Board members, please take your seats. The NOSB Board 

meeting is back in session. The first order of business this, this morning is the Policy 

Development Committee report and the proposals and recommendations plus public 

comments. Chair Colehour Bondera, please proceed. 

Colehour Bondera: Thank you, Mr. Chair. Yeah, I would like to go ahead and start with –

Michelle, can you put up the first slide, please? – with the, the Policy Development 

Committee. I will briefly introduce it. And I have not used what I am holding in my hand 

before so hopefully it works. I am using a remote modifier to that machine, but it seems 

to work fine. 

So the Policy Development Committee, briefly, what we, what we, who we are, what we 

do: provide guidance, clarification or proposed standards of Board operations, policies 

and procedures; maintain the content and updates to the NOSB Policy and Procedures

Manual and New Member Guide; work with other committees to develop joint 

recommendations where policy issues are involved. And as was introduced, I am the 

Chair of the Committee, C. Ruben Walker is my vice chair. Other members include Jay 

Feldman, Jennifer Taylor, Barry Flamm, Jean Richardson, Joe Dickson, and Mac Stone. 

And I must thank, like he told us before, Barry Flamm served in the role that I am in for 

four years so he is not the easiest act to follow, but try, I will.

Well, it worked up to... Okay. Sorry. I apologize. 

So then, we have, our Committee has three recommendations that we are here to talk 

about and in the order that they are going to be presented in: conflict of interest, public 

comment, and public communications. And like it says, these topics were prioritized for a 

variety of, from a variety of sources: the, the NOP, the public, an internal NOSB request 

for review and updates of Policy and Procedure Manual. The honest truth is, in several of 

the cases, it was, it was, you know, more than one, but not in all. The conflict of interest 

recommendation was actually put forth at the Savanna meeting in November. And it was 

tabled and has now been substantially revised, the recommendation we are looking at. 

The public comment was presented at that same meeting as a discussion document so we 

have seen it before and it has also been substantially revised. If I fail to say in the future 

the fact is, that I was the person that was the lead and am still on the lead on that but I 

must formally thank Jean Richardson for the role that she has played since she joined the

Board on that particular recommendation. Like I said, in case I forget to do so in the 

future, she well deserves it. So thank you, Jean. And public communications

recommendation is to establish a policy on public communications. 
Meeting Of The National Organic Standards Board

May 24, 2012

4

And so my intent is, and I have not said all of it, but is to just go through the three 

recommendations. C. Ruben Walker will be presenting the first one in a few moments on 

conflict of interest. And then I will take back because I am the lead person and present 

about public comment. And then it will go to Jennifer and Jennifer will present about

public communications. And then it will come back to me and we can have what we need 

as discussion and the public comment that we have at that time. So, with that, I would 

like to – and like I said electronically I am not sure if I can figure out how – but I am 

going to put this down and turn it over to Calvin. Thank you.

Calvin Walker: Good morning. 

Crowd: Good morning. 

Calvin Walker: Good morning. That is good. Again, I would like to thank the PDC for giving me 

the opportunity to take the lead on this particular important issue. While everyone is halfsleep, I suggest that you strap on your seatbelts and we can get through this real fast and 

we can move on to other topics on the agenda. 

I am ready. Next slide.

As Colehour mentioned, the chair of PDC, stakeholders at the Savanna meeting was 

overwhelmingly in support of our conflict of interest documents but I am a person that 

likes to try to bring about a consensus, even with those who might be in the minority to 

try to craft together something that could be of benefit to everyone. And some, someone 

once said that a consensus is something that both sides are still pissed off in the end. 

Crowd: [Laughs].

Calvin Walker: So I think at the end of this, we will see that both sides will still be ticked. Maybe 

that is the better word since it is being... Could you scratch that from the transcript?

Crowd: [Laughs].

Calvin Walker: Okay. [Inaudible] Okay. The next slide here, Colehour suggested that I get 

through these real fast and I definitely will do that. The, first I would like to mention that 

conflict of interest probably had its beginning during the Biblical days when Adam, Abel 

and Cain had a issue. You know, Cain killed Abel because God accepted the offering of 

Abel so maybe that is where conflict of interest began, or maybe with Eve and Satan.

Crowd: [Laughs]. 

Calvin Walker: As, as it relates to a broad view of conflict of interest, there are over 1000 

advisory committees. They provide advice to over at least 50 departments. The cost per 

year is $390 million each year and they are projected to go up at least another 20 million 
Meeting Of The National Organic Standards Board

May 24, 2012

5

each year. The public is definitely concerned about the advice that these advisory 

committees are giving to these agencies that make policy. And our Board is no different. 

Overview: NOSB is seeking to enhance its conflict of interest policy by providing 

additional definitions and outlining some general procedures for declaring, evaluating, 

and acting upon a conflict of interest. How did this come about? Not by the Policy 

Committee, but it came about by several stakeholder groups: National Organic Coalition, 

Cornucopia, Center for Food Safety, Food and Water Watch, and there was several that 

was just individual citizens just saying that we need to enhance our conflict of interest 

policy. At the Savannah meeting, we was intent on bringing this forward. But we 

withdrew it because a couple of stakeholders group, that, that their comments are very 

valuable and of value to the organic industry, trying to get a consensus, we tabled it to 

make some substantial changes. So Board member, Joe Dickerson [Dickson] and I 

worked on this to try to improve it from where it was. Okay, next page.

Purpose: I think I have already said that. We will go to the next slide. I know everyone is 

happy on that if we move along. 

Background: The original proposal that we was intending on sending forward, we had a 

definition for several types, types of conflict of interest. We outlined the steps and we 

outlined the steps for conflict of interest in TRs and a declaration of interest form. 

So what we did was and try to get a consensus and move this to the Board, because we 

know that the Board will ultimately, NOSB will ultimately make that determination. 

Because I remember in June of last year, I called the Office of the Inspector General. I

talked to the Deputy, I think her last name was Diaz, I have forgotten the name. The 

question she asked me was, after 20 min-, we had a 20 minute conversation, and she 

essentially said it was left up to the Agency. And I tried to, when you are dealing with 

lawyers, you have to kind of tune in on all the words that they say. But in essence, she 

said it was left up to the agency. If that was a problem, the agency will contact them and 

not our Board. So she was very polite in telling me that and we began to talk about Cajun 

and Creole foods in south Louisiana. 

Crowd: [Laughs]. 

Calvin Walker: So she was very diplomatic in saying that if the agency have a problem, then 

they would get with them to, to get that rectified. Upon that, I did, I think I approached 

someone at NOP and they just encouraged us to go ahead with all the policy until they 

could get some firm and definitive answers. So the PDC Committee on Conflict of 

Interest are trotting along. Okay, as it relates to stakeholders written comments, 91% of 

the stakeholders that responded to what was put out on the website, 100% agreed with 

recommendation number one. Recommendation number one was to keep the current 

policy on page 8, I believe. And recommendation three, to outline a procedure for the 

Board in dealing with the conflict of interest, there was a 100% agreement. As I said 

before, the majority, the 91%, they still wanted some form of conflict of interest for those 
Meeting Of The National Organic Standards Board

May 24, 2012

6

who testify, expert testimony, conflict of interest surrounding TRs to also be looked at 

another time. So to try and get this moved this along, we removed the... 

Oh, ahead of myself. That slide was alright. We have, we have, the PDC COI Committee 

have three recommendations. Recommendation one, everyone that submitted pub-, 

written testimony had no problem with recommendation one. They had no problem with 

recommendation number three. And three groups had a problem with recommendation 

two. So we was in the process of trying to work that one to satisfy those who had a issue 

with some of the definitions. But by the time the PDC Committee could act on that, the 

Program, like CNN breaking news, had came up with recommendations that came from 

the, the Ethics Office as well as their Program. So we did not have a chance to address 

some of the comments of some of the stakeholders that wanted to see a different 

definition of some of the words, of some of the language we was using. 

Okay, Recommendation number one essentially is already in the policy. Nothing was 

changed. No one had a issue with this recommendation. 

Recommendation number two dealt with definitions. The Program has weighed in and we 

appreciate them weighing in because it would have saved us a lot of sweat, but, such is 

life. Recommendation one is the definition of a conflict of interest. That came from NOP

upon consultation with the Office of, I believe, Ethics which give a, a definition of 

conflict of interest similar to what we had initially. And it also dealt with immediate 

family members. Some of the concerns of some of the groups that did not like the 

definition of conflict of interest, it was broad because I had parents, grandparents, 

biological stepchildren, you know all that kind of stuff. You know you may have to have 

a family reunion and try to get all these financial interests. But the Program I thought on 

consultation with the, with the Ethics Office came up with something that was very nice. 

So immediate family member is now limited to parent and the spouse or partner, as well 

as your children that are in the household, as opposed to your uncle, you may have a 

problem with your uncle anyway. So you, you may not want to try to deal with that. So I 

was really pleased to see the definition of immediate family member shortened because 

we did have one that was quite broad. Of the last definition, direct financial gain, nothing 

was changed. It is already in the policy. 

Recommendation three essentially says that if you have a conflict, if you disclose, if you 

have a conflict of interest and if it is financial, you should surface that at the committee 

level as well as at our biannual meetings before you discuss and as well as vote. But 

going forward, the Program, upon consultation with legal, our Chair Mr. Barry Flamm, 

the process you used yesterday was the one that will be going forward is that the Board 

will not decide if there is a confl-... If Calvin – I guess I called my own name – disclosed 

that I have a conflict of interest, the Board will not determine if that is a conflict. It will 

be determined by the Program. Like yesterday, when Zea disclosed that she had a conflict 

and the Program, upon hearing the nature of it, made a determination whether it was a 

conflict of interest or not.

Comment [JMS1]: 00:15:00
Meeting Of The National Organic Standards Board

May 24, 2012

7

Moving along. We are almost finished here. Summary: The revised conflict of interest 

policy and procedures are an attempt to address several stakeholders’ requests for 

updating the Board’s conflict of interest policy providing a greater level of transparency 

in the deliberation, discussion and voting on matters pertaining to the Board for the 

benefit of the organic community. The second item, every stakeholder that wanted a 

tough, leaner, meaner, clear conflict of interest policy we did not address the issue that is 

related to public testimony, expert, I mean, expert testimony, consultants, and technical 

reviews. These groups that was in favor from the beginning believe that conflict of 

interest need to also be dealt with individuals that come before us to, to give their expert 

advice on a matter. 

And I think at some point, if not next, our next meeting, but in the near future, that we 

would if the Board, if the Board and Program concur, that we need to look, at least put 

this out in the form of a discussion document. May not be in term of a technical reviews 

but I think the Board, NOP have a policy all, already for technical reviews. Well they use 

the term covered relationship. But if we are to listen to our stakeholders, and maybe it 

would provide a better collaboration, cooperation with the different groups if at some 

point soon, that we would look at seeing what our stakeholders as a whole think about 

conflict of interest as it relates to that for experts who come before us and consultants. So, 

the PDC Committee is saying that we would like to see this particular proposal go 

forward. We know that what this Board do is not to make rules or regulations but to 

advise, at the next level changes and corrections will be further modified.

The Board met on Monday evening with these revisions. Actually, the Board, NOP had 

some additional changes but it would have been so much so we decided that we would 

make some changes to our policy and at their level, they would along with the, the Ethics 

Office, for the refining. 

Barry Flamm... You can see we have a good cross-section of support. Barry Flamm, yes. 

Jay Feldman, yes. Joe Dickerson [Dickson], retailer, yes. Mac Stone, certifier, no. Jean 

Richards [Richardson], public interest, yes. Jennifer Taylor, yes. Colehour Ben-, I should 

know as much as I talk to him [laugh], Mr. Hawaii, Colehour Bondera, organic producer, 

yes, and yours truly said, yes. 

Ten more slides. Just kidding. And the last slide is c’est tout. That is it. 

Colehour Bondera: Michelle, can you put that slide back up? Thank you, Mr. – yeah that guy 

over there, the Louisiana guy. Thank you very much. I appreciate it. 

Crowd: [Laughs].

Barry Flamm: A little pay back.

Colehour Bondera: Do what we got to do, you know. So, yeah, I hope that that was useful and 

helpful for him to, to do that. And I am just going to move us on to the next 
Meeting Of The National Organic Standards Board

May 24, 2012

8

recommendation at this point in time. So now that we are, we are all slowed down and we 

have done the big thing, now we get to go on to the easy things. Hum. Very good. 

So the next one is our, let us see, I am going to have to give you some background before 

I go into this, I think. 

What we are going to do is we are going to look at the policy for public comments at our 

meetings. And the truth is that the recommendation that was publicized is what I am 

going to present to you right now and read through. However it is worth noting that our

Committee has discussed changes. However, since our Committee has not agreed upon 

any, our, our whole Committee has not agreed upon changes and in fact, I have

Committee members including something that you just heard from Mr. Walker, of ideas 

of additional things or different ways that, since I am under, under occupied as the

Committee Chair, that our Committee should be putting a little bit more energy into and 

putting into the work plans and things like that. My point is that there, there are even 

some proposed modifications to the modifications that have already been circulated 

within the Committee but not concluded upon. And so I will be referencing some of those 

but what is going to be presented right now is the recommendation as it has been put 

forth. 

And this one is not as, I think, easily separate-able into categories as what we just saw in 

terms of distinct recommendations. However, several of the items that you are going to 

see already exist in the Policy and Procedure Manual and there has been no suggestions

for changes. And that is... Actually, when you look at this, that is the first two paragraphs 

already exist in the PPM and there are no suggested changes from public and/or from the 

National Organic Program and/or internally. 

And so I can still read through those. All persons wishing to comment at NOSB meetings 

during public comment periods must sign up in advance per instructions in the Federal 

Register Notice for the meeting. So you will be happy to hear, if we call that 

Recommendation number one, that there is no contest.

Anyway, item number two: All presenters are encouraged to submit public comment in 

writing according to the Federal Register Notice. Advanced submissions allow NOSB

members the opportunity to read comments in advance electronically, and – [sigh] God, I 

mean I, I have to interrupt myself just to say that electronically has been last night and 

this morning, quite a interesting issue for me, so I do not know if it is always a viable 

option to be saying it is going to be a possibility, but – and decrease the need for paper

copies to be distributed during the meeting. So that item also has not received any 

discussion or suggested changes and that will change henceforth. 

Number three: Persons will be called upon to speak in the order they sign up. Persons 

called upon who are absent from the room could potentially miss their opportunity for 

public comment. And in the revision that we will be discussing in a few minutes as a

Commit, as a Committee probably, then as the NOSB, before we vote on this, this one 

has several changes, notably, the fact that people will be called upon if they sign up but 
Meeting Of The National Organic Standards Board

May 24, 2012

9

we cannot guarantee it will be in the order that they sign up. Because we are not 

necessarily,... People may have signed up but then they are talking on a topic that is in a 

different order than where they wanted to be. So the concept is that people will be called 

upon if they sign up. And we cannot also focus on, you know, there are time, potential 

time constraints of the meeting which could be an issue as well and the word potentially 

will be eliminated so there is a couple of details. 

Number four: Excuse me. Time allotment for public comment per person will be three 

minutes with the option of extending to a maximum of five minutes at the discretion of 

the Chair during the meeting. And we – actually when I get, in a moment, to public 

comment on this issue, you know – have received quite a bit of response to that particular 

item and I think that there is, you know, we can still discuss that further, but I think it is 

standing at this point in time with the variation going to be that it is at the discretion of 

the Chair in collaboration, association, or connection with the NOP and/or FACA rules. 

So I think that that is an issue we are going to have to straighten out in a few minutes. 

Number five: Persons must give names and affiliations for the record at the beginning of 

their public comment.

Number six: Proxy speakers are not permitted.

Number seven: Public comment requests may be scheduled by the Board by major topics 

under consideration. On that item, our, we have discussed but again, like I said, have not 

finalized eliminating the “by the Board” clause in that part of it.

Number eight: Individuals providing public comment will refrain from any personal 

attacks and from remarks that otherwise impugn the character of any individual. 

So I am going to carry on to the next one. Excuse me. The next part of that, which is also 

in the Policy and Procedure Manual. Two paragraphs that are in there. The NOSB will 

attempt to accommodate all persons requesting public comment time, however 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 NOSB Chair depending on the availability of time. And, that one has pretty much in 

discussion remained where it is with elimination of the NOSB at the beginning, with the 

replacement of the word “we”, we will attempt is what I have put forth as a internal 

discussion and at the end, where it says the NOSB Chair, that is going to get some 

additional descriptor referencing the NOP and/or FACA rules. 

So finally, 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. And I am going to, I am sorry to say, move on 

and we will come back to those things. 

In terms of written public comment on this public comment recommendation, 93% of the 

comment received were supportive. Most of those, 84% of those, though do, did present 
Meeting Of The National Organic Standards Board

May 24, 2012

10

conditions to their support. And it is worth noting that comments came from both 

individuals and groups, from consumers, farmers, interested citizens, farmers, like I said, 

farmers associations, trade associations, advocacy, non-profits, the whole range were, 

were represented in public comment. Here is a few quotes from my presentation that I did 

on the, on the letter to Vilsack I used the same process. So nothing new here. Right? In, 

in other words, here is a, there are subsets of, of quotations from comments we received. 

Nothing I think really new but it is worth noting. 

“Allow more time for public commentary.” Like I said, that is a notable subset of the 

comments and that is the item number four that I presented in reference to that. Several, 

sev-, a few of the comments were: “The ability to comment by proxy is especially helpful 

for public interest organizations.” And it is worth noting that that was part of, of what we

received as well. Another one was: “Be flexible according to the circumstances.” And I 

think that that is very important. I think that Barry has done a, a very good job of doing 

that during this meeting in my opinion but I think that, you know, that is where, where

things are ideally is be flexible as much as we can, like that person said. And again a, a 

repeated kind of comment, but in quotes like it says: “Prefer, prefer to see a stand, 

standard five-minute comment period that is adjusted downward.” And that is instead of a 

three-minute that would be increased upward as the recommendation reads.

I think on this public comment recommendation, you know, the N, the NOP comments to 

us internally have indicated that the DFO, the Designated Federal Officer, is responsible 

for how these details are scheduled. And so I think that that was worth noting. And, you 

know, we are going to receive a little bit of live testimony and if, if some of it is 

specifically on, on this recommendation, then, you know, we will be dealing with that

before we vote on the recommendation. So that is going to bring my public comment 

recommendation presentation to a close. And I just want to say “mahalo” for listening to 

that. And I am going to, at this point in time, request that our third recommendation be 

presented. And Jennifer Taylor is going to present about public communication and, so I 

will pass the mike to her.

Nick Maravell: [Whispering]

Colehour Bondera: [Whispering] Yes. Thank you.

Jennifer Taylor: Thank you. Good morning. The National Organic Standards Board Policy 

Development Committee has put before the public a proposal for public communications. 

And I am going to read it to you.

An introduction: A primary role of the National Organic Standards Board is to advise and 

counsel the Secretary – thank you, [whispering], okay – is to advise and counsel the 

Secretary to represent the segments of the population from which they were selected and

to treat the business of the Board as fiduciaries for all members of the organic community 

and public at large; coming from the Policy and Procedures Manual page four through 

eight. The Federal Advisory Committee Act meeting obligations to, to the public suggest 

that any member of the public is permitted to file a written statement with the advisory

Comment [JMS2]: 00:30:00
Meeting Of The National Organic Standards Board

May 24, 2012

11

committee during meetings. In addition, the NOSB infrequently receives public 

communications outside of the designated public comment period. These 

communications include verbal and written information. 

Background: The Organic Foods Production Act, enacted under title 21 of the 1990 Farm 

Bill serves to establish uniform national standards for the production and handling of 

foods labeled as organic. The Act authorized a new USDA National Organic Program to 

set national standards for the production, handling, and processing of organically grown 

agricultural products. In addition, the Program oversees mandatory certification of 

organic production. The Act also established the National Organic Standards Board

which, which advises the Secretary of Agriculture in setting the standards upon which the 

Program, the NOP, is based. Section 2119 of US, 7 USC 6518 states that the NOSB

consist of four individuals who own or operate an organic farming operation, two

individuals who own or operate an organic handling operation, one individual who owns 

or operates a retail establishment with significant trade in organic products, three 

individuals with expertise in areas of environmental protection and resource 

conservation, three individuals who represent public interest or consumer interest groups, 

one individual with expertise in the fields of toxicology, ecology or biochemistry, and 

one individual who is a certifying agent.

The statutory mission of OFPA states: 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 Section 2119(a). As stated in the 

NOSB Policy and Procedures Manual, page five, the NOSB mission statement is: to 

provide effective and constructive advice, clarification and guidance to the Secretary of 

Agriculture concerning the National Organic Program and the consensus of the organic 

community. 

In carrying out the mission, key activities of the Board include: assist in the development 

and maintenance of organic standards and regulations, review petition materials for 

inclusion on or deletion from the National List of approved and prohibited substances, 

National List, recommended changes to the National List, communicate with the organic 

community including conducting public meetings, soliciting and taking public comments,

provide timely information and education on the NOP, making reasonable use of a 

variety of communication channels, communicate, support and coordinate with the NOP

staff. 

The Policy manual, page eight, states that the NOSB members shall act impartial,

impartiality [impartially] and not give preferential treatment to any organization or 

individual. The PPM indicates that to fulfill their responsibilities, Board members agree 

to adhere to three duties, duty of care, duty of loyalty, and duty of obedience. The PPM

continues.

The duty of care calls upon a member to participate in the decisions of the Board, 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 
Meeting Of The National Organic Standards Board

May 24, 2012

12

study the information needed to make a reasonable, 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. 

The National Organic Standards Board members study and evaluate all public 

communications, written and verbal communications, as a function of the NOSB role and 

duties in order to benefit the organic community. In so doing, National Organic Standards 

Board members are able to provide effective and constructive advice, clarification and 

guidance to the Secretary of Agriculture and to the NOP. 

The NOP said in the National Organic Program newsletter, December 11th 2011: The

members of the National Organic Standards Board and the National Organic Program 

often receive letters and requests from people interested in our upcoming regulatory 

activities and meetings. In this note, we summarize the best way to direct your letters and 

requests. As a federal advisory committee, the NOSB has a well-defined scope of 

activity. If you have opinions and requests to share with the Board, please use the public 

comment period that is open before each NOSB meeting to submit your thoughts, or

submit a formal National List petition for consideration using the guidelines provided in 

the link below. 

The NOP is the best place to send your letters outside of the NOSB public comment and

petition process. In addition to formal public comment periods on specific regulatory 

actions, we are always open to comments on a variety of topics related to organic 

agriculture. While we cannot guarantee that every letter we receive a direct response,

your letters do get an audience and help us identify and prioritize needs. We look forward 

to hearing from you. 

This explanation by NOP describes the current official means of communication out lied, 

outlined in the PPM which does not prohibit other forms of communication between the 

public and the NOSB members. The NOP statement, however, suggests a need to clarify 

the ability of the public to communicate with NOSB members outside of the Board 

meetings and the public comment period to inform the un-, ongoing deliberations of the 

Committee work. 

In summary, the National Organic Standards Board, through its Policy and Procedures 

Manual, establishes procedures for its activities. The manual is designated, is designed to 

assist the Board in its responsibilities, on page four. And establish procedures for 

carrying out its responsibilities in accordance with its advisory mission. Because of the 

opportunities that the Board has to hear from the organic community in the course of 

fulfilling its mission, it has both an opportunity and responsibility to bring to the 

Secretary of Agriculture information that it believes may impact on the implementation 

of OFPA. This communication may, by necessity, extend to organic standards and 

practices as well as related issues that may affect those standards and practices. 

Therefore based on the communications and input it receives from the public, the 

National Organic Standards Board may provide effective and constructive advice, 

clarification and written information as it deems necessary directly to the Secretary of 
Meeting Of The National Organic Standards Board

May 24, 2012

13

Agriculture after each of its Board’s, Board meetings. Additionally, and as a part of its

responsibility to communicate with the organic community pertaining to the 

implementation of OFPA, the Board may receive and review information from the NOP 

and other sources during its deliberations. As a stakeholder Board, the input from the 

organic community is valuable in the deli-, in the deliberations of the Board and the 

community decision-making process. The procedures of the Board should facilitate 

public communication with Board members in the course of those deliberations.

Recommendations: PPM section six, miscellaneous policies, page 26, is amended by 

adding a new subcategory, which is provided in italics. NOSB policy on its Advisory 

Board and communication with the Secretary of Agriculture: Based on the 

communications and input it receives from the public, the National Organic Standard 

Board may provide effective and constructive advice, clarification and written 

information as it deems necessary directly to the Secretary of Agriculture after each of its

Board’s, Board meetings. This information is intended to facilitate public communication 

with the Secretary on critical issues that may emerge that it believes are important to the 

implementation and integrity of the organic standards and practices under the Organic 

Food Production Act. 

PPM section six, miscellaneous policies, page 27, is amended by adding a new 

subcategory, which is provided in italics. NOSB policy for public communications 

between NOSB meetings: The NOSB accepts public communications to NOSB members 

outside of Board meetings and public comment periods to inform the on-going 

deliberations of Committee work. The Board requests that communications on specific 

subject matters be sent to the entire Board membership of the relevant Committee or, on 

matters relating to the full Board, be sent to all Board members. 

PPM section two, page 13, role, role of the Executive Director, is amended to include the 

following language: Receive and maintain an archive, archival record of all 

communications submitted by the public to the National Organic Standards Board and 

make communications available to the Board members. Maintain a public listing posted 

on the NOP website of contact information for NOSB members including an e-mail 

address or other points of contact. 

We had a Committee vote and five of the Committee members, I am sorry, six of the 

Committee members voted in favor of the proposal. Two members were absent. 

Colehour Bondera: [Inaudible]

Jennifer Taylor: We are going to be leading to the, no, I am going to PowerPoint. I have a, yes. 

Michelle? Could, okay, control it where, here? Here. [Laugh] Oh, here. Okay. Okay, 

thanks. Okay. Okay.

Michelle Arsenault: Press here, that should go forward. [Inaudible]

Comment [JMS3]: 00:45:00
Meeting Of The National Organic Standards Board

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14

Jennifer Taylor: Okay. I will now provide a review of the written comments. And I needed to ask 

Michelle or someone from Program, did we receive any comments through the mail?

Michelle Arsenault: [Inaudible]

Jennifer Taylor: They were, they are included. Okay, thank you. 

This is a review of the public written comments that have been provided by the organic 

public, consumers and stakeholders. A written review of the comments: A review of the 

written comments indicated that the majority of commenters supported the proposed 

recommendations. One commenter stated that the National Organic Standards Board, in 

carrying out, that the National Organic Standards Board, in carrying out its statutory 

responsibilities, plays an important role in bringing to the USDA information,

experiences, and perspectives directly from the organic community.

We support both elements of the proposed public communications policy. It is very 

important that the NOSB be able to express to the Secretary of Agriculture the views of 

the organic community that it receives. This is particularly true of views that may be at 

odds with current or proposed US pop, USDA policy such as the views of the organic

community concerning so-called coexistence with farming you, farming utilizing

genetically modified organisms. 

The transparency policy, this is another comment, the transparency policy passed at the 

last Board meeting will, when implemented by the NOP, allow for the public to follow 

NOSB deliberations more closely. This policy will allow for those who have information 

useful to the Board to provide that information in a more timely fashion. As a follow-up 

to these comments, we applaud the Policy Development Committee for bringing this 

public communications policy recommendation forward. 

The policy as written provides the proper balance between inch, ensuring an open and 

collaborative process with the organic community while giving the NOP the ability to 

establish the most cost effective means of achieving this policy goal. 

Another comment: We urge approval of the recommendation that has been proposed. The 

NOSB is intended to represent the organic community as a whole. This would be more 

easily accomplished if the community were able to provide input throughout the NOSB 

decision-making process.

Another comment: We har-, we heartily endorse the Board's clarification as to their role 

in communication with the Secretary of Agriculture, and the ability of the public to 

communicate at any time with the Board. 

It is the statutory responsibility of the NOSB to communicate to the Secretary on any and 

all issues relating to the organic, relating to organic that the Board deems important. 

Additionally, it is necessary that NOSB communicates, communicate issues of concern 
Meeting Of The National Organic Standards Board

May 24, 2012

15

directly to the Secretary regarding organic, that they have heard from the public, whether 

or not it is the subject of proposed regulations, standards, or recommendations. 

Another comment: The NOSB not only has the statutory authority, but also the 

responsibility to directly communicate issues of critical concern from the greater organic 

community directly to the Secretary of Agriculture. 

Another comment: These issues include those of the NOSB bi-annual agenda and those 

outside of the Board's agenda which members of the public are compelled to raise in their

written and/or verbal comments. 

We also strongly believe that the NOSB’s work is greatly improved when experienced 

stakeholders are consulted during a Committee development, a Committee’s development 

of a discussion document, proposed guidance and/or recommendation.

We also had comments in relation to the concept of a public docket. These comments 

included: To facilitate communication between NOSB Committees and the public to 

receive comments, this would be a valuable mechanism for stakeholders to engage 

individual Committees on critical issues of concern to their constituents. 

Another comment: We fully support the following addition to the policy manual as 

proposed by the pop, PDC. The NOSB policy on its advisory role in communication with 

the Secretary of Agriculture and it goes on to include the, the paragraph that we 

proposed. 

We support of the following addition to the PD manual, the NOSB policy for poba-, for 

public communications between NOSB meetings. Opportunity for public comment

should not be limited to the official public comment period.

We received a comment from the Program on May 10th as a result of a, a meeting that 

they held with the USDA Committee Management Officer. The Program’s comments 

follow. 

They suggested to add to the third line – are you able to go there Michelle? In the 

recommendation? They suggested to add in the third line of the, of the proposal, NOSB

policy on communications with the Secretary: We request that the phrase “directly to the 

Secretary of Agriculture” be modified to read “to the Secretary of Agriculture, through 

the NOP’s Designated Federal Officer”. We request that the phrase “directly to the 

Secretary of Agriculture” be modified to read “to the Secretary of Agriculture through the 

NOP’s Designated Federal Officer”. The USDA Secretary delegates authority and 

responsibility for the NOSB to the NOP and the DFO. It is specifically required to be the 

point of contact for Board communications. The NOP will ensure transmission of any

letter to the Secretary through the appropriate chain of command. To ensure both 

appropriate delivery and consideration, we ask that the letter not be sent directly to the 

Secretary by the Board. 
Meeting Of The National Organic Standards Board

May 24, 2012

16

Okay, oh, okay. Yeah. I am back to the private one. Anyway. Okay. Thank you, yeah.

The comments continued. For public communications between NOSB meetings, in the 

section on receive, and maintain, and archive, archival record, the NOP will be happy to 

research and propose a year-round mechanism and archival record by which public 

feedback can be received and posted for public viewing by both the NOP and NOSB. 

This general communication mechanism needs to be set up outside of the FACA driven 

meeting public comment process so it will need to be established as a forum by which 

people can provide feedback to the NOP and the NOSB, not just the NOSB. The solution 

also needs to be selected with an eye to staffing resource demands, as NOP would need to 

administer and monitor this kind of mechanism.

That is right. That is written down.

The comment from the Program continues. For public listing of NOSB members, this is 

not a proposal the NOP will be able to accept. We are not permitted to post Board 

members’ info, personal information on our site. The public feedback mechanism that is 

established, that is established, previous bullet, is the best way for people to share their 

thoughts with the NOSB outside the meeting-driven public comment process. 

Okay. That completes the com-, the comments from the Program, as well as those, a

summary of some of the comments that we received from the public. And I just added a 

note that the National Organic Standards Board members’ contact information is 

currently avail, available on the NOP website. And it is currently available for, for the 

public. That concludes my presentation. Thank you.

Colehour Bondera: Thank you, Jennifer. At this point in time, I would like to turn the mike over 

to the people that have signed up to make public comment to our Committee on these

recommendations, etc. And so we have two people that are signed up. Is that correct, 

Michelle? So Will Fantle from the Cornucopia Institute, if you could step forth. And I 

have David Rogers in queue. Thank you.

Will Fantle: Yes. Good morning everyone, my name is Will Fantle. I am the co-director at The 

Cornucopia Institute. We are a research and farm policy organization, national 

organization. Most of our members are organic farmers scattered across the country. 

Want to welcome the new Board members. You signed on for quite a ride here. 

A policy issue is, is something too that is becoming and has become aware to us of the 

increasing importance of it. We had not followed this as closely, but the need for robust 

discussion, not stifled, transparency, and a vibrant and full exchange of information is 

something that has become more and more apparent and obvious to us. So I think the 

Board is well served by the policy recommendations, many of them which are brought 

before you today. Some that we would propose some tweaks to. But your Board chair 

who served for four years on this Committee has a pretty good perspective and he has 

been able to observe and watch and monitor the proceedings of this Board and I, I think 

that has contributed to the breadth and wisdom of some of these recommendations.
Meeting Of The National Organic Standards Board

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17

Three minutes: You have heard many commenters up here in the last few days that have 

said it is just too short. Not only does it stifle the breadth and fullness of a presentation, 

but it also has a tendency to degrade it as people start talking really fast and trying to get 

all their words in. It becomes difficult to understand and comprehend the nature of what 

they are trying to convey to you when that occurs. People are anxious. They have been 

lots of things that they want to share with you. And we think that some tweaking of that

is worth doing, going to five minutes. We think that proxies are something that are worth 

bringing back. Proxies have afforded us in the past, to bring other voices before the 

Board to populate this discussion with former NOSB members, who are advisers or 

Board members of our organization, farmers. In one case, we turned even over a proxy to 

a retailer to allow that person to present their information to the Board. 

Conflict of interest: I want to add some remarks to something that I know you are going 

to be considering in the future and that deals with TRs. You need to know who the 

authors of the TRs are. You need to know if there are conflicts of interest there. Those 

individuals that come before this Board and, and testify as well as from the public, I think 

it is wise for you to know who they are representing and what conflicts they may have. 

Consultants that come before you rarely are hired to advocate for the public good. It is 

principally for an economic interest of a client. You should know that. You should weigh 

that in your decision. 

Board communications: You need to be able to hear from people during the entire year, 

the whole process. This is particularly important when proposals are being analyzed and 

assessed during Committee proceedings when you can get full information. Thank you. 

Colehour Bondera: Yeah, I would like to see if there is any questions. Jay, you have a question?

Jay Feldman: Yeah. Thank you, Will. You among some other organizations take advantage of 

the opportunity, or exercise what you believe is a right I take it, to communicate directly 

with Board members, correct?

Will Fantle: That is correct. It is something that has not been something that we have done real

often during our history, but it has become more frequent in the last year and a half or so 

as we try to share views and information with Board members. 

Jay Feldman: How the heck did you find their personal information? 

Will Fantle: [Laugh] That is why we are researchers. 

Jay Feldman: Was it difficult? 

Will Fantle: In some cases, very difficult, yes, that is not easy to find, but certainly, mailing 

addresses have been much easier to find. Electronic can be quite difficult but we take a 

pretty good look and dig and dig and dig. 

Comment [JMS4]: 01:00:00
Meeting Of The National Organic Standards Board

May 24, 2012

18

Jay Feldman: How would you feel about a public docket system as opposed to communicating 

directly with Board members who, by the way, sometimes feel overwhelmed by having 

direct communications with the public. You are aware of that, right?

Will Fantle: Totally understand that, that you can be overwhelmed by the volume of 

communication. Unfortunately, I think that is one of the things you signed up for, as, as

part of the job. Public docket I think would be helpful. That would be another venue that 

I think people would take advantage of and to try to provide information that 

comprehensively could be collected and aggregated. 

Jay Feldman: My final question: would, would you use that instead of direct communication, or 

would that be sufficient? Would you feel that? Because what I am hearing on our end, is 

that that might help to organize the flow of information in a way that would be less 

disruptive, you now, to all the other work people are trying to do as part of their, their, the

jobs that put food on the plates. 

Will Fantle: Right.

Jay Feldman: So would you, would you utilize that system feeling it was adequate, an adequate

form of communication with the Board? 

Will Fantle: We would utilize it. I am sure of that. I cannot make a firm commitment that that 

would be the only path of information that we would use. 

Jay Feldman: Thank you. 

Colehour Bonder: Other questions, Board members? Yeah, I, I have one myself. Will, thank you 

for your presentation. I, you said something in reference to the number of minutes in the 

public comment part, that I would like to hear your response to something else that I have 

heard regarding that, which is, a reference, or reflect upon or respond to whether or not it 

is the number of minutes that a testifier is given to testify or how does that relate to or is 

associated with the amount of time that that person can receive questions from Board 

members of their testimony. Can you associate those things? 

Will Fantle: Yes. What has been proposed for Board questioning of commenters I think is an 

improvement to over what we have recently seen. So I think that is good. The amount of 

time, many of us come with multiple issues to talk about and discuss and the three 

minutes is just a very difficult perimeter to fit all that information into and try to convey 

it to you in a meaningful fashion. We do take advantage of written testimony. We provide 

that in advance. Others do as well. But we know you are overwhelmed and we also know 

that many Board members, reflecting upon their experience on the NOSB have 

highlighted this particular aspect of the NOSB hearing public comments in public 

testimony is one of the things that they enjoy and take a lot out of. So I think it is 

important for you to allow that expression, if the Board members also are benefiting from 

this type of discussion. So I, I think it enhances the level of discussion and the 

conveyance of information.
Meeting Of The National Organic Standards Board

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19

Colehour Bondera: Thank you. Other questions? Mac, you had a question.

Mac Stone: Will, do you all feel that public testimony has any more gravity than written, 

submitting written comments? 

Will Fantle: It is hard for us to know that without being in the decision-making aspect of the 

room. I, I do know from having been an elected official myself, and participating in 

numerous public hearings, the value of, of public testimony and the impact that I have 

seen that that has upon my fellow Board members, when I was on the County Board, in 

the decisions that they made, some people process information differently. Verbal has 

more impact for some people than written. I, I just notice that in my participation in the 

public arena.

Colehour Bondera: I am going to go Nick and ...

Barry Flamm: Colehour, [inaudible]

Colehour Bondera: ... yeah, and then Harold.

Nick Maravell: Will, you, you sort of addressed the question I am about to ask, but many of us 

have had the, the experience of presenting public testimony and being on many sides of 

the table. Do you have any models in mind of other bodies that you might suggest that 

could inform how this body would work? 

Will Fantle: Well, I do not know that I have anything that, I have witnessed anything that is 

uniquely different. I will say that what we had in the past, and historically have had 

before the National Organic Standards Board, I think was an improvement over what we 

have gone to the last few meetings with a fuller discussion and the ability to bring in 

other voices to populate that discussion with proxies. That worked pretty good. 

Colehour Bondera: Harold? 

Harold Austin: Will, thank you for your testimony. You made a comment about the consultants’

expert witnesses being allowed to testify. I, I know that can be a kind of a two-way 

dynamic that takes place, but is not there also value to that testimony, from those types of 

peoples, if used in the right context to take and help enlighten and enrich the knowledge 

of the Board and the, and the people that are here? I mean, would not you think so? 

Will Fantle: Please do not misconstrue what I am saying about prohibiting their testimony. I am 

not advocating that at all. I merely advocating, and we are advocating, that they disclose 

who they are representing and what that brings to the table so that you can factor that into 

your decision-making. I know it makes a difference. The Planning and Development 

Committee hearings that I have sat on when the advocate comes and wants to add 

something or develop a property in a certain way, you know what his interest is. And you 
Meeting Of The National Organic Standards Board

May 24, 2012

20

are able to factor that into your decision-making as it pertains to other interests when they 

present testimony. So.

Harold Austin: Thank you for that clarification.

Will Fantle: Yes. 

Colehour Bondera: Very good. Thank you very much, Will. I appreciate your testimony. Do we 

have David Rogers? Thank you.

David Rogers: Good morning everyone, I am Dave, I am David Rogers, a policy adviser with the 

Northeast Organic Farming Association of Vermont. NOFA Vermont is one of the oldest 

organic farming associations in the country. We are a member NOC, and I am presenting 

NOC’s comments this morning on the Policy Development Committee’s 

recommendations. 

NOC fully supports the rec, these recommendations to amend the Policy Manual to 

clarify conflict of interest definitions and procedures. It increases transparency, and, and 

therefore, increases the quality of the, the Board's work and the integrity, and protects the 

integrity of organic products and is consistent with the core principle of continuous 

improvement, which should include procedures of the, of the Board. So these 

recommendations send us down the road and, and are improvements, go some way in 

improving transparency but they do not go far enough. There is a missing piece and that 

has to do with, that has to do with the experts, expert consultants and folks involved with 

technical reviews. 

The rep, technical reports directly affect the quality, completeness, and integrity of the 

Board’s deliberations and decision-making, particularly those pertaining to the addition 

and removal of substances to the National List. I think we all know that we are way 

beyond the time when the work of scientists and the judgments of scientists can be 

naively assumed to be somehow removed from personal interests and affiliations. These, 

these interests may be financial. They may be direct. They may be indirect. But they may 

affect the objectivity of, of experts’ judgments. This is why codes of professional content, 

conduct routinely requires the disclosure of such interests. This is why professional 

scientific journals, at least the better ones, require authors to declare financial interests

and sources of funding. So for these reasons, for the, in the interest of integrity, in the 

interest of continuous improvement, in the interest of transparency, it is clear that conflict 

of interest policy should include those who provide the Board with technical information. 

This information should be, the disclosure should include direct and indirect financial 

interests that may constitute a conflict of interest. They should declare sources of 

funding, business associations that have the potential to affect the objectivity of their 

work and without this, the Board simply cannot have full confidence in its deliberations

and decisions and be, be assured that its work will depend on reliable and objective 

information. The Center for Food Safety, which is also a NOC member, has proposed 

draft language for conclusion in conflict of interest.
Meeting Of The National Organic Standards Board

May 24, 2012

21

What do we have? Oh. [Sigh] Okay. Ask me a question. 

Crowd: [Laughs] 

Colehour Bondera: Very good, thank you. Do I, do we have any questions for David? Yeah, go 

ahead, Jean. 

Jean Richardson: Could you continue and give me some clarification? I am not really quite 

following what you have in mind.

David Rogers: Well, I will, I will read this draft language from the, from the Center for Food 

Safety. This is the recommended language for inclusion in the, in the conflict of interest 

policy. 

Consistent with its conflict of interest policy, the NOSB seeks to ensures that contractors 

and consultants who provide research services to the NOSB do not stand to financially 

gain from any recommendations it makes with respect to the addition or removal of 

substances from the National List. Therefore purveyors of such services will be requested 

to sign a conflict of interest statement prior to the commencement of their work which 

explicitly states that there is no actual or perceived direct financial interest to be gained 

from the outcome of their research that could prejudice the tone, scope, or conclusion of 

the report in question or impair the individual or Agency’s objectivity. If a given 

contractor or consultant is unable to or unwilling to sign the statement, then another 

individual or agency will be sought out to do the work. 

Colehour Bondera: Go ahead, Jean. 

Jean Richardson: Dave, have you already, has NOC already submitted this to us in writing? 

Because, I, I know I have heard the general concept of what it is you are talking about, 

but the specific language, do you know if that has been already submitted [inaudible]?

David Rogers: The specific language was submitted as part of Center for Food Safety’s written 

testim-, testi-, comments and NOC supported those in their comments. 

Colehour Bondera: There was another person with question? Sorry.

Barry Flamm: Calvin had...

Colehour Bondera: Sorry? 

Barry Flamm: Calvin had...

Colehour Bondera: Calvin, did you have a question? 

Calvin Walker: We did get information back from the Program. I do believe that something need 

to be done that relate to expert testimony as far as a conflict of interest. At the university, 
Meeting Of The National Organic Standards Board

May 24, 2012

22

when we write grants, we have to sign conflict of interest statements. One of the 

comments I got back from the Program, maybe the Program can add more, they use the 

term “Federal Acquisition Regulation” dealing with a covered relationship where 

contractors are asked to declare a conflict of interest. But I, I definitely agree that as a 

person on the Board, to know who is the author of TRs. In one instance, we do know that 

one of the references apparently did not concur with what was said, what they said in a 

personal communication and it can sometimes present a problem. So we hope at some 

point that we can look at that. 

David Rogers: I think such disclosure and transparency should extend to public commenters as 

well.

Calvin Walker: I agree.

David Rogers: I, I think it is a, I think the Board should perhaps make clear to presenters that this 

is what their expectations are. That, if you have financial interests, direct associations, 

that you would urge presenters to divulge those. You expect them to. I think most people 

do a good job of that. But there is plenty of opportunity for non-trans-, non-transparency

up here. 

Colehour Bondera: Jay.

Jean Richardson: Dave, is there a, you have been in this business for a long time. Is there a, a

broad spectrum of perception that the technical reports are done by a limited stable of 

expert witnesses, so to speak, that do not necessarily represent the interest of a broader 

range of stakeholders or that they have biases, that are not... I understand you do not

think they are always fully disclosed, but are they sufficiently biased that you feel the 

NOSB, in their technical reports that they receive, are not getting the best range of 

information and data? 

David Rogers: I, you know, have been in the business for a while, yes, but not particularly 

paying close attention to this aspect. I am not, I am not sure what the quality of the

disclosures are with respect to those doing, conducting technical reviews and because of 

that, I think the policy needs to make it, to ensure that becomes more apparent, becomes 

more public and, but I do not, I do not have any personal information would indicate 

whether or not there have been problems in the past or what the, whether associations 

have caused conflicts of interest. We just need to get this out, make transparent. It is

consistent with protecting the integrity of organic products. It is consistent with the 

notion of continuous improvement. 

Jean Richardson: Thank you.

David Rogers: I would also sup-, NOC, NOC also supports the idea of improved and continuous

communications. This was discussed earlier. And the, the concept of a public docket is 

one that is of interest to us.

Comment [JMS5]: 01:15:00
Meeting Of The National Organic Standards Board

May 24, 2012

23

Colehour Bondera: Yes, Jay? 

Jay Feldman: Thank you, David, for your testimony and the work you do. I want to switch gears 

here a little bit to an issue that came up pretty recently and Jennifer referenced and read 

from the Department or from the Program on the issue of communication directly with 

the Secretary of Agriculture. And given your long work on policy issues, I am, I am 

really interested in your viewpoint on this. I am, I, I ask you this in the context of policy 

because many of the things that I am hearing from the Program feel to me as an erosion 

of authority of the Board, the NOSB. And having been again, having been at the table 

when the law was written, this was, this Board was really established to have a, a large 

degree of independence, as you know, you were around at the time as well. And, and to 

create a, both a collaborative relationship but a check and balance on, on that relationship 

and so there was some degree of independence including convening, convening technical 

advisory panels and communicating with the Secretary of Agriculture. Now while on a 

bureaucratic level, I do not feel like it is a big deal that we send our letter to what, 

someone who happens to be a really nice person, who I trust will send the letter on to the 

Secretary. From a policy standpoint, do you feel that is an inappropriate or appropriate 

position for the Program to have? 

David Rogers: Well, I think, I think OFPA provides for direct communication from this Board to 

the Secretary. So I, I would say, I would say any requirement that it pass through the 

Program first is, as you characterized it, an erosion. So and I think it is important again 

for the, in the interest of protecting the integrity, the perceived integrity of organic out 

there, that this, this Board, which is represents the public and the organic community, the 

organic world as a whole, has the power to direct, to communicate their positions and 

concerns directly to the Secretary.

Colehour Bondera: Thank you. Nick has a question. 

Nick Maravell: You referred to the way that OFPA is constructed. I noticed in the Program 

comments that Secretary has delegated the authority to the DFO, the Designated Federal

Officer. Do you feel that the Secretary has the ability to delegate the Board's authority 

that is statutorily given? 

David Rogers: [Sigh] I think that is above pay grade. 

Crowd: [Laughs]

Nick Maravell: Okay. 

David Rogers: You know, I, there are so many pressing issues; the question of genetic 

engineering, of course, highest on the list, at least in terms of my thinking. Efforts to 

communicate concerns and express suggestions and such, I think it is tremendously 

important at this time with respect to that issue to have communication as open and as 

direct as possible and so I, I would say to the Board that it should work to restore the 
Meeting Of The National Organic Standards Board

May 24, 2012

24

power that they have under OFPA and to insist, if they can, to, to maintain that, the

prerogative to, to communicate with the Secretary directly.

Colehour Bondera: Very good. Thank you very much for your test-. Sorry, go ahead, Calvin. 

Excuse me.

Calvin Walker: What is your view on time? I notice, this is my third meeting, expert testimony, 

stakeholders make comments. As a researcher, sometime it takes a while to digest things 

and sometime we make changes in 30 minutes, one hour. And we notice that local school

boards, City Council, Supreme Court, you know, they hear sides and at some point later 

on they make decisions after digesting all the information coming before them. What is 

your view, or the NOC’s? Do you think we have, we make enough, allowing enough time 

to kind of deliberate on such important information that come before us ...

David Rogers: So you are, you are ...

Calvin Walker: ... in such a short time? 

David Rogers: ... you are talking about time for the Board to consider ...

Calvin Walker: Yes. On certain issues. Yeah.

David Rogers: ... its decisions on some issues? I think it is, you know, I have, I have been out 

there for a few years witnessing what you all go through and I think sometimes it is akin 

to drinking from a fire hose. And to, to expect on very complex issues, issues where new 

information comes to light in this exchange, this kind of exchange, and then to have you,

sort of, later that day or 36 hours later or something, to expect you to have digested all of 

that, discussed it, and come to the most, you know, the best decision, I think that is 

unrealistic. I think the Board, I think you all should feel free to say, look, we know we 

were going to vote on it but now we really need more time. And then through an open 

docket process between this meeting, for example, and the next one, you could continue 

to get information, continue to think about it, and then come back right off the bat at the 

next meeting vote. Other issues, less, less difficult, you just stick to your plan and, and

have a vote. But, you know, whatever is best I would say, whatever leads to the best 

decision, whatever is, you know, going to in the end help us protect the integrity of 

organic agriculture and, and continuously improve the, the work of the Board. 

Colehour Bondera: David, thank you very much for your testimony. I appreciate it. 

David Rogers: Thank you.

Colehour Bondera: At this point in time, I would like to request that we, as the NOSB, discuss 

the recommendations that have been put forth. From my perspective, it would be most 

appropriate if we could go through them in the order they were presented, and have a 

discussion first about the conflict of interest, and then move to the public comment, and 

then move to the public communications since that is how they were presented. And, if 
Meeting Of The National Organic Standards Board

May 24, 2012

25

people are willing, then if people have questions or discussion or about the 

recommendations put forth so far, that will be fine, or... Yes, go ahead, Mac.

Mac Stone: Can you, Michelle, can you put the conflict of interest back up please, the 

recommendation section?

Michelle Arsenault: [Inaudible]

Nick Maravell: [Whispering] 

Colehour Bondera: Me too. 

Nick Maravell: [Whispering]

Colehour Bondera: Yeah. Sorry. Yes? Yeah, go ahead.

Mac Stone: While she is getting that up, I know we were discussing this the other evening: is the

word “potential” or “perceived”, we were having that conversation. What was that final 

draft I guess is my question?

Colehour Bondera: Calvin, can you address that? 

Calvin Walker: Oh, okay. I am sorry. As I mentioned earlier, trying to get a consensus and based 

on some of the information given to PDC by the Program after discussing with the Ethics 

Office, they essentially seem to have left it up to the Agency. And the definition of 

“conflict of interest” that we are putting forward was derived from that. Because the 

Ethics Office seemed to say that that is left up to the Program as a Board, as opposed to 

this Board. So, the definition that we have seen there is, it came from the Program. So, 

they may want to give us a little bit more than this. But we tried to capsulize it in this 

short form. 

Colehour Bondera: Yes, Miles.

Miles McEvoy: Yeah, we have, we have learned a lot about the FACA over the last few months. 

We shared a lot of that information in our, my opening, opening remarks on Tuesday 

morning. And we have committed to work with the Policy Development Subcommittee

on, on revising the Policy and Procedures Manual in, in alignment with the, what we are 

learning from the FACA rules. So we are very engaged in working very collaboratively 

with the, with the Policy Development Subcommittee to, to make that happen so that we 

are aligned both with OFPA and the FACA requirements. So that is going to be an 

ongoing project. We will be working on that over the summer. We really look, look 

forward to collaboration on that. 

So we have learned a lot about conflict of interest over the last few months and 

specifically, it is important that Board members research any actual and potential 

conflicts of interest. So the Ethics Office and the, and the Community Management 
Meeting Of The National Organic Standards Board

May 24, 2012

26

Officer do use the term “potential conflicts of interest” in, in their definition of conflicts

of interest. So it is a little bit broader than the, the conflict of interest definition that is in 

the current NOSB Policy and Procedures Manual. So it is important that Board members 

research any actual and potential conflicts of interest because of their organizational 

affiliation or relationships before they came, they come to the Board meeting. This is as 

much about the appearance of conflict and loss of impartiality as it is about actual direct 

financial interests. So again that is broader than the past definition of conflict of interest.

Members need to self-assess for self, proposals. Are there any areas where there could be 

any, an actual or potential conflict of interest? Do your homework before the meeting. 

We will be providing, you know, more specific information on this as we move forward. 

If a Board member discloses having a conflict of interest and offers to recuse him- or herself, NOP will accept that, no questions asked. You do not need to give the details of the 

conflict, just state that a conflict exists. Because there may be times when you just want 

to recuse yourself, you do not need to necessarily tell people why. If a Board member 

discloses a potential conflict of interest and uncertain as, as to whether he or she should 

recuse him- or her-self, then the NOP will make the determination, the Agency makes 

that determination about whether a conflict exists and will instruct the member 

accordingly as to whether or not to vote. We are committed to doing that in a fair and 

consistent way. We are learning about this as we, as we go along and we will, we will do 

our best to, to do that as, in a fair and consistent manner. 

In regards to the actual proposal, we do encourage you to, to move forward with, with

your proposals on conflict of in, interest and those other proposals. That will be very 

good for our guidance as we move forward. 

Specifically, proposal one: let us see. Okay, there are three elements of the PDC proposal 

related to conflict of interest. The key point is, under FACA, the NOP is responsible for 

Board operations. The NOP will, will be working closely with the Board, the USDA

Committee Management Officer, and the USDA Office of Ethics to review the Policy 

Procedures Manual over the summer to help definitively guide the Board's work in the 

future. The NOP, working closely with our USDA Committee Management Officer and

the USDA Ethics Office, will review what the NOSB sends forward. 

Proposal one relates to keeping standing conflict of interest language in the PPM. The 

NOP will review this existing language with our USDA Committee Management Officer 

and the USDA Ethics Office to determine what changes may be appropriate in the PPM 

moving forward. We will work closely with the Board through this process. 

Proposal two relates to definitions. The NOP provided feedback to the PD, PD 

Subcommittee from our Ethics Office on definitions related to “conflict of interest” and 

“potential conflict of interest”. We will again review these recommendations with the 

Committee Management Officer to determine what changes may be appropriate. 

Comment [JMS6]: 01:30:00
Meeting Of The National Organic Standards Board

May 24, 2012

27

And then, in terms of procedural steps, we will need to make adjustments to 

recommendation three. I think this has already been addressed. To, so that the, it is the 

agency that makes the decision on conflict of interest, not the Board. So, thank you. 

Colehour Bondera: Yes, Mac.

Mac Stone: I am going to vote to move this forward. But thinking as a certifier, and as an 

inspector, we sign a conflict of interest ahead of time. And maybe pragmatically, if, as 

Miles just stated, if a Board member is evaluating the agenda ahead of time, I mean, this 

might be played back into Committee deliberations, not just sitting at the Board table. 

But, so maybe we should think about preparing this ahead of time so Zea is not 

wondering if she should recuse herself at the table and disclose all that. That, if we could 

do that ahead of time, would be greatly consistent with the way we accredited certifiers 

operate for that matter. And it can be pre-vetted before we get here. I would also just like 

to suggest maybe if Calvin is leading this, if you could kind of give us some case studies 

and hear some examples of where you would or would not so that we can sort of evaluate 

our own position with the various topics. 

Colehour Bondera: Calvin, did you want to respond? Or Zea, you have?

Calvin Walker: I agree. What Mac had mentioned. And Miles also, the Program also mentioned 

that we have what? Two calls per month. At any point in time, a, a conflict, a disclosure 

may be necessary. And so the Program has committed to quickly, shortly coming up with 

a path of how do we deal with that. Because in the course of a call, you know, something 

may arise. And one may have to disclose if they have a conflict. So that issue, you know, 

still need to be worked out. And we think that the Program can get that done in short 

order. Because we should disclose it, not just at the bi-annual meetings, but it should be if 

it occurs, Mac, you know, when we are on a Livestock call, or GMO call, we need to be 

able to, to get clearance to continue to participate in that discussion on those. But I agree

with Mac, as I said.

Colehour: Yes, Zea.

Zea Sonnabend: I agree with that advanced one. And for those of us who are in a position where, 

you know, it appears from this new policy that, for each vote, I would have to say 

something like: I work for a certifier who may certify products containing any of the 

ingredients that we are about to be voting on. Likewise, Joe works for a retailer that 

might carry any ingredient. And it, it does not make sense to say that before every single 

vote. So maybe we could do those kind at the beginning of a meeting or advance, and you 

say, okay, you cannot vote on anything, or, we can. 

Miles McEvoy: Yeah, that seems very reasonable to, that this before the meeting, to know what 

those interests are and determine whether or not anyone needs to recuse themselves on 

any particular issue. It, it would be a much more thorough and consistent process to do it 

that way rather than to do it on the fly at the meeting.
Meeting Of The National Organic Standards Board

May 24, 2012

28

Zea Sonnabend: And because, is the new policy going to make us recuse ourselves on everything 

because of that? Even if we work for an hourly rage, wage but our company certifies 

everything? 

Miles McEvoy: No. 

Colehour Bondera: Yes, Jean.

Jean Richardson: Yeah, this is a really question to Miles. So we seem, we appear to be different 

from the other FACA committees in, in this issue of conflict of interest because 

obviously each of us are appointed to represent something or somebody, some entity. So 

are there other, any equivalent situations that, that you have come across on FACA 

because now obviously we have to really pay close attention to the FACA, make sure that 

what we do is in accord with all of that, and yet we have this unique nature and 

construction. 

Miles McEvoy: No. The point is, is that you are a FACA committee and you need to follow the, 

the procedures that other FACA committees are following regarding conflict of interest 

and ethics. And so that is where we are working closely with the commit, Committee 

Management Officer and the Office of Ethics to ensure that, that there is that consistency

from this Board to the other FACA committees that are within USDA.

Jean Richardson: Yes, I understand the need for consistency and it is a good idea. But again, are 

there other FACA committees which are with people who are similarly appointed 

specifically to represent entities where obviously there, there is a bias in the background, 

because that is why they are appointed. So if you are a retailer, or a handler, et cetera, you 

are specifically appointed to represent that perspective. Are there similar situations on 

FACA committees that you are aware of?

Miles McEvoy: I, I believe that most FACA committees are going to have people that are 

representing specific interests, because you want to have those interests to be represented 

to have good decision-making and good input. So this is a, a normal process is to have a 

FACA committee with a diversity of interests that are stakeholders in the topics that are 

being discussed, so that, that is not different than other FACA committees. There are 

some unique natures about the NOSB. You have some statutory authority that is 

relatively unique and maybe, maybe completely unique in terms of FACA committees. 

Yeah.

Colehour Bondera: Yes, Calvin.

Calvin Walker: Since given this task, I have noticed that the NOSB conflict of interest seem to, 

to be probably, to me, the most advanced. I have looked at a few and our policy on 

conflict of interest seem to be much more advanced than some of the others. Some refer 

to have immediate family member in their... There is one from the Department of 

Interior that was recently formed, I think, two years ago. They mention immediate

conflict of interest should not be allowed by Board members and “immediate family 
Meeting Of The National Organic Standards Board

May 24, 2012

29

member” but they did not define what was “immediate family member”. So in our regard, 

seem like our policy is kind of far ahead of the game. 

Colehour Bondera: Very good. In an attempt to move us forward, if there is no more discussion 

about conflict of interest. Oh, there is more. Let us wrap it up with John, I hope. John.

John Foster: Just a comment I mentioned at the Develop, the PDC meeting the other night, was 

that, just a, a comment and a, a hope that, that we use our language really carefully. That 

most of the dialogue I hear, we are using the word “conflict” when we really mean 

“disclosure”. And I think we should be very careful about the language we use, 

particularly on those two words. That is a very, that is a big distinction, and as, as we 

have seen, a small word can move a lot of people. So I just would urge us to use 

“disclosure” when we mean disclosure, “conflict” when we mean conflict. Be very 

deliberate about that. 

Colehour Bondera: Yeah, I mean that makes a lot of sense to me, but I think that my 

understanding of that reality is that you need to disclose things in order to verify if there 

is or is not a conflict often. So I think that they are directly associated even though they 

are not, not synonyms is I think worth, worth noting. Jay, Jay, you had a comment.

Jay Feldman: Yeah. I mean a lot of this information is new to us. We, you know, we deliberated 

on this for many months and these issues were just brought to us at this Board meeting in 

terms of the implications of FACA. I mean it was always my understanding that this

Board was exceeding, to some degree, the FACA requirements, was putting in, was 

putting in standards that were tweaking FACA, maybe creating more onerous restrictions 

because of the, the sensitive nature of the relationships that we all have with our 

stakeholders and the community generally. But there is nothing in the training that we all 

have received as part of, as part of our ethics training that would indicate the degree of 

detail that is now being, was presented to us during this meeting for the first time.

And I, having looked at it and, and consulted with people, believe that some of these 

interpretations are incorrect. So what do I do with that at this meeting? What I would 

suggest we do as a Board, just to protect ourselves, to not institutionalize things that may 

be an incorrect interpretation into our own PPM, is that we just refer to our policies in 

addition to whatever we think is correct, whether it is potential or not potential, if we 

want to use that word or not use that word. That we should not be instructed by any

interpretation at this meeting as, as to FACA rules, but we should just put a qualifier in 

what we do that would say subject to FACA rules. So that way we are acknowledging 

FACA plays an important part in what we do, but we are not advancing an interpretation 

of FACA that may be incorrect. And I believe, in many cases, is incorrect and we will 

find out after the fact is incorrect but we will have institutionalized those 

misinterpretations into our PPM. So if we just put the clause “subject to FACA rules”

into our PPM in addition to whatever we believe is correct governance for the Board, 

then we will have both met the Program’s need to be in alignment with FACA and meet 

our own needs to govern the NOSB in a manner that we were statutorily approved to do. 
Meeting Of The National Organic Standards Board

May 24, 2012

30

And that is just a compromise, hopefully, that we could reach pending more deliberations 

on the subject of interpreting FACA and how it applies to a Board that we were told, 

during our ethics training, makes us all representatives, not government employees, not 

special government employees. And if you remember the slides, there were three slides 

on the ethics presentation. One was on government employees. One was on special 

government employees. And one was on representative. And we were told that we were 

representative. And the distinction on ethics application of ethics law was different on our 

slide than it was on the other slides. So there obviously is a distinction there. And I would 

like to see it in writing, similar to what you just des-, your discussion, Calvin, with 

David. You know, it, this does require some deliberations. I would hate put something in 

our PPM that is, that ends up being a misinterpretation. 

Colehour Bondera: Yes, Nick.

Nick Maravell: Yes. Jay, just to add to your comments, I read from the statute: The Secretary 

shall establish a National Organic Standards Board in accordance with the Federal 

Advisory Committee Act. So is that basically what you are trying to accomplish here?

Colehour Bondera: Go ahead, Calvin. 

Calvin Walker: So, Jay, you are essentially saying to the motion add the phrase “as subject to the 

FACA rules”? 

Jay Feldman: Yeah, I am just, I am just saying, if we are being asked by the Program in this 

meeting to put in something that we are told is a FACA responsibility, that we do not 

really need to do that at this meeting. It just is my position, that we can simp-, if the 

Program believes that we are doing something out of line with FACA, we can just add 

the phrase in “subject to FACA rules”. And this goes for the next proposal as well

regarding, you know, the, the issue of public comment and how the Board is run by the, 

by the, the Board Chair that we, as the NOSB, elect. I think that too and, and when the 

NOP steps in and does not step in. I think we should just establish what we believe is 

correct process for the NOSB and then add the line “subject to FACA rules” and at, at

that point, we can get an, an inter-, or at a later point we can get an interpretation as to 

what that really means. 

Colehour Bondera: Yes.

Jean Richardson: I have listened to these comments over the last few minutes and, like Jay, a lot 

of what we heard at this meeting was news with regards FACA and we are aware of the 

fact the NOP is going, going to continue to clarify what language is the most appropriate 

over the summer. Are we foolish to go ahead and vote on this in a sort of a semicomplete way today? Should we wait and hold the voting until the fall? 

Colehour Bondera: Yeah, I do not. Mac, do you want to comment on that?

Comment [JMS7]: 01:45:00
Meeting Of The National Organic Standards Board

May 24, 2012

31

Mac Stone: Just, just glancing at the Policy Manual on page nine, it looks like that the, there is a 

header or initial says that kind of states we have an inherent conflict of interest and it is a 

way to protect ourself from ourself. But you could just add at the end of that Jay’s 

statement. The sentence reads, prevent – excuse me – prevent overt advocacy, direct 

financial gain, appearance of self-interest, appearance of wrongful activity, NOSB has 

adopted the following conflict of interest policy subject to FACA rules and then there is 

these definitives that we have come up with to kind of clarify that specific to us. But it 

would be easy to insert in my opinion. 

Colehour Bondera: I, I do not know if you are comfortable with me doing this or not, Miles, but 

do you have any response based on the fact that when you were talking, you, you

mentioned that you thought that the NOSB should move forward with these 

recommendations at this point in time? Related to this conversation, do you have 

anything to add? 

Miles McEvoy: Well, I would say that what we have learned is that we need, we need to make 

the Policy and Procedures Manual align with the FACA requirements. And there will be 

some changes that are necessary. So if the Board did move forward with these 

recommendations as you would with any recommendation, the Program then reviews 

them and responds. So we would be able to provide that clarification to the, the

recommendation from the Board to clarify anything that we need to under the FACA

rules. So having a recommendation on these topics does not stop the process of us 

reviewing those recommendations and getting back to you with any clarifications or 

changes that would be needed. 

Colehour Bondera: Very good. I would like to move us on to a as-brief-as possible discussion on 

the public comment recommendation at this point in time. I do not know, Michelle, if we 

can put up those pages on, from what I gave you. I did converse with the Committee and 

did, via difficult electronic communication processes, try to make some modifications in 

various ways this week. But now I just want to propose some modifications to the 

recommendation as it stands at this time before people respond further to it. 

In item number three: I do not know if you all can see it there because of the cross-out 

parts, but instead of, yeah, I mean, you can read it, it, I am getting rid of “in the order 

they sign up” of like I said when I presented this and adding “subject to the time 

constraints of the meeting” and eliminating the word “potentially”. So I think that those 

are the critical components of that modification there. 

And I am going to go down to number four, where we are going to start to enter into what 

was just raised because what the, what the, what it says right there and I think that 

Michelle should be able to change it right now. Jay is suggesting that we change that

wording to read, the red words would read “the discretion of the NOSB chair, subject to 

FACA rules”. So it would eliminate the, it would eliminate “the NOP working closely 

with” from this suggestion. And that is repeated one more time further down. 
Meeting Of The National Organic Standards Board

May 24, 2012

32

I guess before I get further down, going to number seven, “by the Board” has already 

been eliminated in the previous slide. And then finally further down, in the, the second to 

last paragraph, the NOSB was eliminated and it says we – there is a little typo issue there 

where “however” is made into a separate sentence – and then the final sentence the 

suggestion was, for change was “in consultation with NOP”. And Jay is suggesting 

putting in that parentheses instead, where it says the NOSB Chair putting “subject to 

FACA rules” to leave it “not already decided”. So that is where... Michelle, did you get 

that?

Michelle Arsenault: No, please repeat it. [Laugh]

Colehour Bondera: Where the second to last paragraph reads “in consultation with NOP” in 

parentheses, the suggestion right now was “subject to FACA rules” instead of those 

words. 

So I would, I would like to hear any discussion that people have on this recommendation 

at this point in time. I, I will mention again, on, at some level I am repeating it, but just to 

make it clear, I did try to work with the Committee to get people's agreement on these 

changes before I presented them, however, because of electronic difficulties, I do not

have everybody's vote on, on the changes that are in red on this document so these are 

coming from, essentially they are coming from me, even though I did end up with a 

second and some votes, it was not concluded. So. Go ahead, Mac. 

Mac Stone: I, I guess I missed something, where we jumped to public comment and that, that is 

in conjunction with the staff of the Program because they received the request and all 

that. So I was thinking Jay’s comment was just on the conflict of interest because we do 

need to work with the Program on the timing of public comment.

Colehour Bondera: Yes, Miles.

Miles McEvoy: Yeah, just a, a point of clarification from what Jay was saying about the, the

Ethics Office and the training. Jay, have you shared the information that you got from the 

Ethics Office from last week? That you asked a series of questions of the Ethics Office 

concerning the training, have you shared that with the rest of the PD, PD Subcommittee?

Jay Feldman: No, I have not had time to do that. 

Miles McEvoy: Okay. So [inaudible].

Jay Feldman: You see, Miles, I did not know it was relevant to this meeting because the 

presentation that you provided us at the beginning came as a total surprise. So I was 

trying to be preemptive just to understand it for myself and so I had not had a chance, did 

not think it was necessary. 

Miles McEvoy: Right, okay. So there is, there is a lot of additional information that Jay received 

from Mary Royster from the Office of Ethics around this particular question of training 
Meeting Of The National Organic Standards Board

May 24, 2012

33

and, and who is a government representative versus a special government representative. 

And we will get that out to the rest of the PD Subcommittee. So it, Jay, your 

characterization of the training, you have gotten additional information and that needs to 

get shared with the rest of the...

Jay Feldman: I do not believe the information I got clarified. The, the information I got simply 

referred to the authority of the NOP to apply applicable laws. That I believe the response 

I got from Mary Royster was inc-, inadequate and confusing.

Miles McEvoy: Right, but you failed to share that with the rest of the, with the Subcommittee

and mischaracterized ... 

Jay Feldman: Well, I did ...

Miles McEvoy: ... the, the training that was offered by ...

Jay Feldman: I did to share it with the Chair

Miles McEvoy: ...Ethics Office so ...

Jay Feldman: ... of the PDC. Miles, I did share with the chair 

Miles McEvoy: That is great.

Jay Feldman: ... of the PDC. 

Miles McEvoy: So we will get that out to the rest of the PD Subcommittee so that everybody has 

access.

Jay Feldman: And we did not think it was relevant to this meeting. It became relevant when you 

brought it up, on your own, without notification to me. At least, I was not aware of any 

notification to the Board that this was a topic of discussion for this Board meeting. So.

Miles McEvoy: It has, it has been shared with the Chair and the, of the PDC and with Barry. So.

Jay Feldman: Right, so, but you are, you are, [sigh], you are suggesting that I withheld 

something from the Board on a relevant matter and I am suggesting back to you that I 

was not aware this was a relevant matter for this Board meeting. I take my responsibility 

here and, and with my colleagues very seriously to be open and collaborative and for, I, I

really I am taken aback by the suggestion that I did not share information that I should 

have. I gave it to the Chair of this commit, of the PDC, not knowing that this would be a

ma-, a, a issue of discussion at this meeting and I believe, I am not sure he knew as well 

the extent to which we would be, be told that there were new interpretations of FACA. 

So, just so the other Board members understand, this was information that I was 

collecting because of communications that were going on in the PDC. That I did not 

realize that this would be a topic of discussion. 
Meeting Of The National Organic Standards Board

May 24, 2012

34

Miles McEvoy: Yeah, the point, Jay did get additional information about your specific question 

that is relevant and it is important that the rest of the, the Committee members see that. 

So I, I am just saying, when you presented that information, you only presented the part 

about the original training and not the additional information that you received and at this 

point, that is relevant and so now we can share that with everyone so that everyone has 

the same information. 

Jay Feldman: I will be happy to send it around. 

Miles McEvoy: Thank you. 

Colehour Bondera: Yes, very good. I, I apologize as the Chair for not having interpreted to make

sure that we all received that additional information. I am sure we all would have 

reviewed it carefully. And I acknowledge that I may have made an erroneous judgment in 

that regard. You have a comment, Nick? 

Nick Maravell: [Inaudible]. 

Unknown Female: We cannot hear.

Nick Maravell: Yeah, I have a additional comment, not to follow up on this specific. Are we 

finished on this specific discussion? Okay. 

My comment and, is that I would prefer to see our comment period remain as it 

historically has been. So I would propose that we set it at a five-minute comment period 

at the discretion of the Chair, in consultation with the Program. I think that has worked. I 

think we have responsibly used our time at the last meetings that I have been at. And I 

think perhaps we may be trying to solve a problem that may have oc-, occurred at one 

meeting and maybe we do not need to solve it at every meeting. And, and Barry has done 

a wonderful job here, you know, at this meeting. We have not had a problem. I think, if 

we had counted the minutes, we probably could have had each commenter, because we 

finished early on both days. We could have had the commenters extend their minutes by 

two minutes. So, I am old school. I want as much public comment as possible. 

Colehour Bondera: Zea.

Zea Sonnabend: Thank you. I agree somewhat with Nick. As a person who has stood on the 

other side of that podium as much as anyone else in the room, I do not feel that 

legislating three minutes is appropriate. It is way too prescriptive. 

I did count up the public commenters we had. And we had 22 on Tuesday, and giving 

them each two more minutes would have added 44 minutes to our agenda. And that is 

assuming the same amount of questions, where the two more minutes may have been able 

to reduce the amount of questions, if anything. Yesterday, we had 25 commenters; that 

would have added 50 minutes. It makes so much difference to the public, those two extra 
Meeting Of The National Organic Standards Board

May 24, 2012

35

minutes or even one extra minute, that I am perfectly willing to sit for an extra hour to 

hear them all. 

However, I do not feel that waiting until we are at the meeting to decide is fair to the 

commenters, because they prepare ahead of time. And you have to rehearse to try and get 

it into three or even five minutes. And so, therefore, I feel like the decision of how many 

minutes should be made between the time the sign-ups close with public comment, you 

know, with the comment deadline and the meeting, and there is a few week period where 

it is totally possible for the Chair with the NOP to look at how many sign-ups there are, 

decide 3, 4, or 5 minutes, and let all the com-, all the people who signed up know before 

they get here. And so I cannot vote for this as-is but I do really strongly recommend the 

advance notice of how many minutes.

Colehour Bondera: Thank you. Do I have any comments on that topic or on the public 

communications recommendation at this time? Yes, sorry, go ahead, John. Sorry.

John Foster: I, I, so before I was on the Board, I, I spoke a few times and I found whatever the 

time limit was, it always seemed too short. So then, when I was on the Board the previous 

meetings, when we went to a three minute time period, I found myself much more 

engaged as a Board, as a Board member. It is much easier for me to keep up. It may seem 

a little chaotic to some but I found it to be just the opposite. I was able to track things and 

pay better attention for a longer period of time and that just worked better for me. I know 

that not everyone works that way but I just want to throw it out there, for those of us that 

do, that worked really well for me. I felt like I was more engaged, more on, on topic, and 

maybe my mind works a little bit differently but, than everybody else’s, but it worked 

great for me. Having said that, if it were five minutes and we kept cadence going, kept it 

moving, that might have the same effect. It, for me, it is more about keeping things 

moving and hearing new ideas, new speakers, new voices, new perspectives. That is what 

keeps me engaged and the time period is not that big a consideration for me. I will leave 

it there.

Colehour Bondera: Yes. Jean.

Jean Richardson: I like the three minutes. And I actually drafted this with, with Colehour. And 

the, on the PDC conference calls, we had considerable discussion on this point covering

the issues, the very issues that Zea was raising, is that if we say it is going to be five 

minutes, I mean I know I have presented in three minutes, five minutes, ten minutes 

many times on other parts of other Boards, so that the first of the NOSB Board meetings 

that I have attended. And I, I think that to, once people are prepared for something, three 

minutes or five minutes is always going to feel too short. But if you are concise, you have 

thought it through, what are the main points you are going to present, and you can clearly 

present them. You will have left enough of a window open for the questions. And I think 

that I have learned much more by the question and answers that we have been able to 

have at this meeting. And I think that all the presenters really did an outstanding job in 

clearly presenting what they have to present in a concise and clear manner. And I 

particularly appreciated the ones that came with an extra piece of paper for us also to read 

Comment [JMS8]: 02:00:00
Meeting Of The National Organic Standards Board

May 24, 2012

36

and consider, which we certainly do. So I, I would much rather see us stay with the three 

minutes, which could be expanded to five, as we did for some of the speakers by saying

“go on talking” when there is time available for us to do that. So I, I would, I can support 

the three minutes and will do so. 

Colehour Bondera: Very good. At this point in time, I would suggest that we bring this 

discussion to a conclusion and take a break. I don't know, Barry, how you feel about that 

and come back for the vote after a break. 

Barry Flamm: I agree with the Chair, that, that we will take a break right now and come back in 

15 minutes and the Policy Committee will then hopefully be able to vote on these

recommendations.

[BREAK]

Barry Flamm: Board members, please take your seat. Colehour, you can proceed. 

Colehour Bondera: Very good, thank you. Aloha, folks. Based on the, the conversations, 

discussion that we had on the Policy Development Committee’s recommendations up 

until this point, I would like to request that we postpone the final discussion and final, 

and the voting on these until, until tomorrow, Mr. Chair, if that is possible for you to put 

that in the agenda that way so we can move on with what is scheduled as scheduled. 

Barry Flamm: Without objection, the proposal is accepted and the Policy Committee, its three 

recommendations will be dealt with tomorrow morning.

Colehour Bondera: Thank you. 

Barry Flamm: Next on the agenda is the Handling Subcommittee, John Foster, Chairperson. 

John Foster: So I was actually expecting to have a little bit of time, [laugh], not knowing this was 

happening. So I, so I beg even more indulgence than I would anyway. So, that, that

would be, that would be a good heads-up to me to know actually. So let me, in a flurry, 

get things up on my computer. Sorry about this. And now I guess I know what, what we 

are going to do tomorrow. That is good. We were just talking about that. Okay. Alright. 

Thank you, Barry. We have got a long list of materials today, a result of actually 

hundreds of person-hours, work on the part of the Handling Committee. It, it still remains 

a mystery to me, a wonderful mystery, that what could possibly motivate six people to, 

who are all busy, all over committed, all tired, and all talented. It is still a mystery to me 

about what, what could possibly drive them all to spend this much time on things. And I, 

it is a lovely mystery. I thank each, each of them. It is all the more striking that we, we 

really have a, a very long list of materials on Handling and the fewest number of

Committee members. We may be asking to amend that in the not-too-distant future, 

seeing as our, our future work plan is pretty heavy also. But I would like to especially 

Comment [JMS9]: 02:03:05

Comment [JMS10]: 02:29:03

Comment [JMS11]: 02:30:00
Meeting Of The National Organic Standards Board

May 24, 2012

37

thank Vice Chair Harold Austin, Joe Dickson, Nick Maravell, Tracy Favre, and Zea for 

all of the dedication, many, many hundreds of hours all together. So, thank you for that. 

I, I am going to go off, off target for just a second here. Because I have been, I, I was 

awake for a long time last night. I was thinking about, what I ended up with, about the 

time the sun was coming up, was that I was wondering why I was here actually. Not an 

existential why are we here, which I am also prone to ask about, but, but mostly why am I 

here right now, today and why is my blood pressure so high. Very interesting. Because as 

I said in my intro, I am, this is my favorite thing in life to do. Like I am, I do not want to 

be with any other community I have ever, I have ever been around. So this is my choice 

to be here. So, but I was up last night worrying quite a bit and the question I got back to 

was why I was here. And once I started asking that question, I felt like, hmm, I wonder 

how many other people have stopped to ask that question. So I am going to take a minute, 

a very short minute and, and give you my, my little piece of it and I am hoping that each 

of you take that and ask yourselves that question. Think, think for yourselves on that. I 

think it will help the dialogue. I think it will help, it will make the discourse very healthy. 

And I think we will find that the ties that, that bind us are much stronger than we might 

have supposed.

So, my, my grandparents, my dad's parents, grew up on farms in northwest Missour-a –

yes, I said Missour-a – outside of Union Star and Savannah, for that, those of you 

familiar with that lovely part of the country. I was real small. My, my grandfather would 

tell a lot of stories, as people from that part of the country are wont to do. And I listened. 

And mostly what I remember is excruciating detail about his time on a plow behind two 

mules. That was his life for many, many years. And he was not worldly, but he was pretty 

wise and no one knew the world better than he did, for, you know, his world, not worldly, 

but he knew his world. Over the Depression, things did not work out so well on the farm 

and we had a little scattering of family all over the place. Prior to that, I am really lucky 

to have a book that my grandmother put together that goes back about 400 years of, of

family. And they were all farmers up to that point that the records disappear, and I, I

think that there were not records before that in the part of England and Scotland they 

came from. But what is cool to me is that I can look back and see in that record 400 years 

of farming families and where they were and where we, where I came from. That is, it is, 

and so I come from a long line of that and I think that makes me a much better person

actually. So it has been very, is has been very heartening to hear the, the farmers speak 

here and talk about how many generations they have been on, on the land. That is, that is 

something that is very meaningful to me and I, I really appreciate. I think it is a privilege 

that we get to hear, hear stories like that.

So, fast forward a bit and I guess back to the, the present here. So I am really privileged 

to, to kind of, to work for a company who has got a mission I really believe in, that is 

provide benefits of organic food to as many people as possible, serve as a catalyst for 

positive change. And I'm guessing that maybe while that is not a mission for everybody, 

that is, maybe it is not written down anywhere but that's probably what most of it is, of us

in this room, that is what makes us get up every morning. That is what I want to get to. 

That is the tie that binds I think. So, that is, that is really why I am here. That is my intent. 
Meeting Of The National Organic Standards Board

May 24, 2012

38

That is my hope. And I think that a lot of us share that whether it is written or not. I think 

it is, obviously it is really important. My job, why I am here, is to represent handling and 

processing communities, that is my, that is the seat that I occupy in the position, so the 

seat that demands that. Obviously respect for OFPA, respect for the Program, respect for 

the standards, we need to act as all consistent with that. But if there is, if I am kind of 

conflicted, the last tiebreaker for me is: does this vote help to put more ground in organic 

production or not? And that for me, I am not saying that is for everybody, that is just for 

me, that is the tiebreaker for me. And so that is why I am here is to get more ground in

organic production. I just want to be very upfront about that. Thank you all for your 

indulgence. And, for those of you that know me, that was a remarkably short period of 

time for me to, to go on about something. 

Crowd: [Laughs]

John Foster: So thank you again. So we have, we are, as a group, reluctantly pleased, to be 

something of a guinea pig in this revised format in that we have a lot of material, 

materials to go through, a lot of discussion, a lot of voting to go through. We are going to 

need to move fairly quickly I think but we want to do a complete job so we may need to 

put one or two votes out to tomorrow. I, I would not be surprised if that was the case. 

The materials we are dealing with today are choline, curry leaf, gibberellic acid, inositol, 

citrus hystrix. At then on Sunset – those were all petitions – then on Sunset, 

determinations for agar-agar, calcium sulfate, carra-, carrajeenan/carrageenan, glucono 

delta-lactone, and cellulose. And then, lastly, we will have a brief update on our

discussions around ancillary or other ingredients. 

So in this format, I check in with the Program yesterday, so we will ask the National List 

manager to provide a brief introduction to a material, I, I believe in the order of the 

agenda, and then – and by the way, I am really grateful for that, I think this is a positive 

thing, I appreciate that about this format. Then the person on the Handling Committee 

who is the primary reviewer will address that, that material with respect to the discussion 

we had, a brief, brief summary of, of public comment. And then we will move to public 

comment in one big chunk. 

I will, I, just forewarning, I would like to ask that after public comment is done, that we 

have a break in mind, because I, one way or another, I think we are going to need it. And 

then lastly, I just ask the public for a little leeway as we work through this new, new 

process. It is going to be a lot of toggling between screens for me and documents for, for 

everybody else. So there may be a little more quiet than people are comfortable with and 

we just need to work to work through that process. So please bear with us.

With that, I would ask Lisa to start out with choline. 

Lisa Brines: Okay. Thank you, John. So the first petition material on the agenda today is choline, 

which there is actually two different petitions. The first petition was submitted in April 

2011 by Nestle Infant Nutrition, Gerber Products Company and it requests the inclusion 
Meeting Of The National Organic Standards Board

May 24, 2012

39

of choline at Section 205.60(b) of the National List as a synthetic substance for use as an 

ingredient in infant formula and toddler foods. Second petition was submitted by 

Ballchem Corporation on June 29th 2011 and it requests addition of the same substance 

to the same section of the National List but with a broader allowance. There, choline does 

not appear anywhere on the National List at this time. To assist in its review, the 

Handling Subcommittee had requested the development of a third-party technical report. 

That report was drafted and provided to the Committee and was available to the public in 

advance of the opening of the public comment period. The Committee did, the 

Subcommittee did complete its review of the substance according to the criteria in OFPA 

and the NOP regulations and has a proposal which was posted on the NOP website also 

for public comment. Public comment was received on this substance, and I believe both 

petitioners are signed up for in-person public comment during this session. And as a 

petitioned substance, the Board will be taking presumably two votes on this substance, 

first for classification and second for the listing motion. And with that I will turn it over 

to the Subcommittee for a discussion of the proposal.

John Foster: Alright. Thank you, Lisa. Zea, you were point on this. If you would, go forward.

Zea Sonnabend: Thank you. Michelle, could I have the choline summary, public summary? 

Okay. First I am just going to read a little bit from our recommendation and then I will 

get into the public comment. Choline is a synthetically made nutrient that also occurs 

naturally in food. It is considered by most regulatory bodies to be essential in non-milk 

based infant formula and is required by the FDA for this purpose. It is permitted but not 

required to be added to milk-based infant formulas. All the organic infant formula brands 

that we could find through an Internet search contain added choline, both milk-based and 

non-milk based. Allowing it in adult foods that are in the “made with organic” category

would allow such foods to highlight the fact that they are fortified while at the same time 

limiting the number of non-essential synthetics in organic processing. 

Now we realize that the “made with” category has not been utilized much by the NOSB

in recent years, but we saw that it might be better than nothing for those companies who 

emphasize fortified food. We, the Handling Committee, felt that synthetic, the consumers 

do not expect synthetics in their food any more than are necessary to produce the food. 

And so fortification is not necessary to produce the food and should not necessarily be 

allowed in the full organic label. However, for infant formula, because human milk is 

very high in choline, but even though it is not regulated in milk-based infant formulas, 

the cow's milk and sheep's milk is lower in choline than human milk. 

So, choline public comments: We received 13 specific comments about choline and a 

bunch of general comments about synthetics in handling. Of the specific comments, nine 

were in favor, three were against and one was mostly raising a point about international 

trade in the “made with organic” claim. All of the ones in favor did not like the proposed 

listing for “made with organic” only and wanted full allowance for choline in all organic 

food. So, I want to specifically address a few of the points made in the public comments. 
Meeting Of The National Organic Standards Board

May 24, 2012

40

One was “choline is essential”. Some people seem to have missed the part in the TR and

in our recommendation that said that: yes, we acknowledge choline is essential but

choline can be obtained from food and synthetic choline is not necessarily essential.

Humans who can choose what foods that they eat can select foods that are high in choline 

and the body can extract choline easily from the highest foods and an, an Internet search 

on foods high in choline brings you lots and lots of information beyond what was in the 

TR, the highest sources of choline include eggs, many types of meat, peanuts, caviar, 

beans, shiitake mushrooms, dried, which have as much as a poached egg for instance, 

milk, and even meatless bacon bits. In fact, choline is a component of lecithin and the 

body can break down lecithin although not necessarily in infants. Choline can be also 

acquired by synthesis in the body where the body can make it from smaller food

molecules. 

So our recommendation was that choline supplementation was not essential, not that

choline was not essential. Many commenters gave us a lot of detail about the ADI, 

average daily intake, and the AI, adequate intake, for choline in people. These have been 

well established and it is well established that the average American diet is deficient in 

choline. We recognize that humans need choline but ADIs alone are not relevant to our

decision. Look at what the average American eats that that recommendation is based on. 

We did not see data from people eating a balanced organic nutritional diet as being 

deficient in choline. Humans who make food choices can get a balanced diet and can 

choose foods that are suff-, sufficient in choline. 

Now, infant formula: Infants do not have the ability to choose what they eat. Human 

breast milk is by far the best source of choline for babies and breast-feeding is by far the 

best alternative. However, the Committee felt that not all mothers are able or willing to 

breast-feed their babies and that is just a reality in life. But it is important for infants to 

get off on the right track when they cannot make their own food choices. And so that we 

felt that allowing synthetic choline in infant formula is the right choice for those who 

must choose formula. By the time baby is able to eat solid foods, a mother can choose a 

varied diet and include foods that are high in choline in, in the diversified baby's diet. 

Okay. Commenters raised the point about GRAS status of choline. We heard input on 

both sides that it was not GRAS and that it was GRAS but there were some C-, CFR 

citations given for its GRAS status so we do not believe this to be relevant to the 

discussion further. 

The argument was given that choline should be allowed as a flavor modifier because –

and I am quoting from a public comment – choline chloride’s unique non-nutritive 

functionality augments the taste impact of sodium chloride which has important 

implications for acceptance and palatability of reduced sodium food. We do not find this

suggestion palatable or important to organic deliberations because this is not even 

fortifications, this is just some food modification function. 

Several commenters pointed out: if organic food manufacturers are not allowed to fortify 

their products, they will not be able to compete fairly with conventional products and this 

Comment [JMS12]: 02:45:00
Meeting Of The National Organic Standards Board

May 24, 2012

41

will harm the industry. We did not see a criteria in the Rule or in OFPA that competing 

fairly is a, a criteria that we use to evaluate materials. We would entertain data in the 

future to determine how many consumers would choose conventional just because a 

fortification over organic food but such data was not presented to us. 

Conclusion on the public comment: One commenter said “choline should not be a 

compromise”. They may not have meant that the way we might be meaning it but we 

agree. And although the “made with organic” idea did not get very much traction and that 

was probably the comp, compromise they were referring to, we are keeping that on the 

table for the Board to vote on. 

Now, with that in mind, we are proposing an amendment because I realize that in 

preparing for this, that we had not been very specific about what forms of choline we 

were adding to the National List and so first, I e-mailed this all to the Handling

Committee a little while ago and Michelle, if you can put the amendment. I am 

requesting changing the motions to refer to the CAST numbers for choline chloride and 

choline bitartrate so we are all clear what forms of synthetic choline. The old language 

said choline as petitioned but that is not really on the National List entry. And so, is that 

okay with everyone on the Handling Committee? I am assuming it is; moving forward. 

Okay. So, thank you. Any questions about choline? Okay, well we will hear public 

comment and then we will come back to it. 

John Foster: Okay. That also caught me by surprise actually. So let me, so we will move to the 

next item on the list, curry leaf. And, Lisa? 

Lisa Brines: Okay. Thanks, John. The next petition is for the substance curry leaf. The petition 

was submitted in August of 2011 by the company Curry Love, Incorporated, who is a 

certified organic handler. This petition for inclusion at section 205.606 of the National

List as an agricultural product, as a non-organically produced agricultural product 

allowed as an ingredient in or on processed products labeled as organic and would be 

subject to commercial availability requirements. In evaluating the substance, the 

Handling Subcommittee did not request a technical report in support of its review but was

ab-, was able to complete a proposal based against the OFPA criteria and the NOP

regulations. So the Committee proposal and the petition have been available to the public 

in advance of the opening of the public comment period for this meeting. Public

comment was received on the substance and the Board will need to take two votes: the 

first is a classification decision and the second as a listing motion. And I will turn it back 

to the Handling Committee for discussion. 

John Foster: Thank you. This is one that I, I was point person on. Let us see. Too many screens 

open, I apologize. Here we go.

So, we did receive the petition. We talked about the curry leaves being natural, not 

reported, as far as we could find, to be toxic or dangerous, a pretty common condiment, 

an ingredient in human diets and that is the rationale why the Handling Committee did 

not request a TR. Also in light of the, the other TRs already in, in queue, there was a lot 
Meeting Of The National Organic Standards Board

May 24, 2012

42

of demand for precious time there so those of the two reasons together, mostly focusing 

on the commonality of it though, and lack of any documented concerns. So we did some 

searches on the NOP database, two major organic certifiers’ databases and few suppliers 

coming up on US supply of, of organic curry leaves and then there was, there are, there 

are more organic pretty high volume outside of the US. Unfortunately, it is one of, one of 

several crops that are under quarantine because of a, a pretty dangerous horticultural pest.

So getting them into the country is next to impossible. In fact, it is as organic because 

they require fumigation, as far as our research could find. So obviously, that fumigation 

would prohibit the materials, would make the products no longer organic. So the, the

availability of quantity was, is just not there on the US market. 

The petitioner indicated that a, yeah, pest species is the Asian Citrus Psyllid, so we did a 

little research on how troublesome that was. It turns out to be quite troublesome for a 

variety of crops and is under a, a pretty tight lid so that is not likely to change anytime 

soon in terms of quarantines or, or mandatory treatments. We did look at volumes of the 

available supply in the US. They are reported to be quite a bit less than what the 

petitioner is looking for, and so based on quantity. Now this, now this is going to reveal a 

little interesting feature on the lack of commonly available or easily available market 

data. TRs do not generally get into that anyway but we did our best to, to call around to 

companies that, that would be interested in creating products that might need this and 

they felt like it was their suppliers that they knew would not be able to supply even a little 

bit of it. It has a pretty, a pretty narrow, a pretty specific flavor profile and adds a specific 

kind of flavor complex to food so there is not a lot of substitutes. Also part of our feeling 

was that we would much rather have helped, you know, push a, a market for organic 

ingredients than to push companies into natural flavors, that is one of our considerations. 

Any question or discussion on that? Yes, Jean.

Jean Richardson: There are a number of other species of this genus. Was there only the one that 

was under consideration and is it adequate to list only one species in the genus? 

John Foster: This is the, the species that, that has the culinary value. So, yes, a lot of other citrus 

crops out there, I am sorry, Murraya crops out there but this is the one, this is the one that 

was under the petition. So and, and to the best of my knowledge it was the one that is in 

common use in, in these kinds of entrees, conventional or organic. Other, other

questions? Alright. Moving on to gibberellic acid. Lisa. 

Lisa Brines: Thanks you, John. The next petition substance is gibberellic acid. The original 

petition was submitted in September of 2010 by Valent BioSciences Corporation, is a 

petition for inclusion in section 205.605 of the National List. There was an amendment to 

the petition that was submitted by the same organization in August of 2011 that would 

expand the use. So the original submission was for post-harvest use, post-harvest 

handling on bananas and the expanded use that was submitted later also included postharvest use on citrus and pineapples. Gibberellic acid does not appear elsewhere on the 

National List but it was reviewed by the NOSB previously in consideration of its use on, 

in crop production. To assist this review, the Handling Subcommittee did request the 

development of a new technical report. That technical report was developed and provided 
Meeting Of The National Organic Standards Board

May 24, 2012

43

to the Handling Committee. So there is actually two hand, two pieces of technical 

information available: the new technical report, which addresses the handling criteria,

and there was an old Technical Advisory Panel report that was completed in 1996 during 

the NOSB’s initial review of the substance for crop use. The Handling Subcommittee was 

able to evaluate the substance according to the criteria under OFPA and the NOP

regulations and come up with a proposal. So the proposal, the technical reports, and the 

petition and petition amendment were all available and posted on the NOP website in 

advance of the opening of the public comment period for this meeting. For public 

comment, written public comment was received on this substance. The petitioner, I 

believe, is also signed up for in-person public comment. For the vote on this substance, 

generally, for Handling Committee, for handling materials, the Committee would vote on 

the classification of the substance, that... This substance has been previously classified as 

non-synthetic during the initial review. I do not know that is needed, but the listing 

motion will be needed to determine whether it will be included on the National List. That 

is all I have. Thanks. 

John Foster: Thank you, Lisa. Zea, you were point person in this. Would you take it from here?

Zea Sonnabend: Yes. A material I am quite familiar with. So gibberellic acid is pretty well

accepted in crops and is non-synthetic. It is derived from a micro-organism fungus and 

the review of this posed some, a few interesting issues. First of all, it is for post-harvest 

use which is not a specific section of the National List. And then second of all, it is a, 

because it is proposed to harvest use, the not, the criteria in the Handling Checklist were 

not all exactly relevant to the same thing as an ingredient that appears in final food. 

So we had some concern on the Handling Committee that while the TR was as complete 

as it could be, we were not getting all the information that we needed to make a decision 

on this. So, reading from our recommendation: Two issues of concern to the Handling

Committee that we are seeking public comment on. The first is whether there are cultural 

practices that would serve the same function in bananas to reduce the disease pressure 

after harvest; and the second is the effect of post-harvest treatment on the nutritional 

content of the fruit. For this reason, it is being recommended for bananas, where the 

nutritional profile is, remains the same, and not recommended for other uses. There was 

information in the TR that pointed to a decline in nutrition from its use on citrus but not

from use on bananas and we were hoping that other information would come in on that

subject, which it did not. However, some information did come on cultural practices. 

We recognize in doing this review that there is a flaw in the Handling Checklist and also 

therefore the TR points that the, the contractor has to address because there is no question 

addressing whether growing practices could reduce or eliminate the need for this 

material. So we would like whoever deals with a checklist in the future on these issues to 

take a look at that subject. 

So as far as the public comments go, we received relatively little public comment, 

especially from growers. We received only eight comments and since they are so few and 

they raise all valid points, I am going to address them indi-, each of them. The comments 

Comment [JMS13]: 03:00:00
Meeting Of The National Organic Standards Board

May 24, 2012

44

were from Valent BioSciences, Organically Grown Company, OTA, Wolf, DiMatteo and 

Associates, OMRI, Beyond Pesticides, Cornucopia, and NOC. Both OTA and OMRI 

pointed out an oversight on my part which is that inerts were not on the Handling list 

either, and gibberellic acid is already form, always formulated with inerts. And therefore, 

they each gave suggested wording for inerts. And we concur with this and when we go to 

make the motion a little later, we will add, we liked OMRI’s inerts wording better, which

is up there on the board. Gibberellic acid for post-harvest, for post-harvest banana use 

only may only be formulated with 2004 EPA list 4 inert ingredients. Much as I hate to put 

List 4 on the list another time, but it is inevitable for this.

Okay. So, OTA, OMRI, and Wolf, DiMatteo and Associates asked the NOSB and NOP

to consider the ramifications of adding post-harvest materials to 205.605 and whether that 

would mean that all other post-harvest materials have to be petitioned. We do share this 

concern and would like the department to comment on their view on this subject. Miles: 

your view on the subject of petitioning for all post-harvest materials?

Miles McEvoy: I am sorry. I was talking to Lisa. Can you repeat the question? 

Zea Sonnabend: Okay. The concern from the commenters about whether all post-harvest 

materials, especially non-synthetics, would have to be petitioned for inclusion on to 6, 

205.605.

Miles McEvoy: Yeah, the Program is looking at guidance for post-harvest materials. If you look 

at the National List, there are post-harvest materials that are on 601 and others that are on 

605. So it is somewhat of a confusing area that is ripe for clarification. I would say that 

the article in the Organic Processing Magazine, from I think it was January issue, it kind 

of explains a lot of the dilemmas around post-harvest materials. That article characterizes 

the current situation very well and we are in the process of writing that draft guidance and 

will have that out for public comment later, later.

Crowd: [Laughs]. 

Miles McEvoy: I would say later this year, but Melissa will kill me.

Melissa Bailey: Yeah. 

Crowd: [Laughs].

Zea Sonnabend: Okay. Thank you. Okay. Back to public comments. 

Cornucopia urges rejecting this because it is a preservative. We reject this argument 

because it is not a preservative. Beyond Pesticides wants it rejected because of the 

purification methods of the gibb with solvents. And also they do not see it as necessary 

for production. We reject the solvent issue until a full classification policy is adopted. We 

will talk more about necessary in a minute. Valent provided testimony that post-harvest 

pitting is a citrus peel disorder that is characterized by the physiological breakdown of oil 
Meeting Of The National Organic Standards Board

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45

glands and is caused by high temperature storage waxed fruit. This is for citrus now. 

Pitting can be controlled by low temperature storage, less than 10 degrees centigrade, or 

application of waxes with high gas permeability. However, refrigeration is costly and 

often difficult to implement, while wax with higher gas permeabilities have gloss values 

that are considered to be insufficient for consumer acceptance. Adding gibb to approved

waxes has been seen to be beneficial to post-harvest storage. We find that argument a 

little odd because suggesting that refrigeration is a good alternative, means refrigeration 

is a good alternative, and so why would we need the material then? 

OGC and NOC both supported the cultural practices idea and OGC was the only one who 

gave direct information about this. They actually did a survey of their banana growers 

and they distribute 6 million pounds of bananas, primarily grown in Mexico with some 

grown by Ecuador and Peru, they also handled 725,000 pounds of pineapples from 

Mexico, Costa Rica, and Hawaii, and 8.5 million pounds of citrus fruit from the US and 

Mexico. When they surveyed their growers of all of these fruits, they found none of them 

had the need or desire to use post-harvest applications of gibberellic acid to support postharvest. They learned from the field managers that the on farm use of cultural practices,

such as attention to soil fertility and removal of infected plant material, combined is the 

best approach for controlling Black Sigatoka disease, which is a prevalent disease in

bananas. They found that using cultural practices reduced the pressure of the disease on 

the fruit and the trees and therefore provided acceptable control of the disease later during 

shipping. They stated that the careful attention to soil fertility and field sanitation also 

improves the long-term health and rigor of their production systems. 

We would like to commend OGC for providing public comment on what we asked for. It 

is compelling to us that cultural practices can be effective in controlling the disease that 

would cause bananas to break down in shipping. We wish we had received more input 

from other areas of the world where bananas are grown so that we can be sure these 

practices are used everywhere. Thank you. 

John Foster: Thank you, Zea. Questions from the group? Colehour.

Colehour Bondera: Thank you, Zea, for what you presented. And I, I, yeah, I have, I guess I have 

a clarification question and I will put my cards on the table. I do grow bananas and I do 

not export them and I do not try to figure out how to preserve them either. But 

nonetheless, I think that this final part of your presentation sort of struck a chord with me 

and maps with my question which is: The concept here is essentially to seek uniform 

ripening, it seems like. And my question is, up until now, what have the bana-, the 

organic banana producers, and I will admit it you know all of the imported bananas, I 

grew-up on a farm in Oregon, people eat bananas all the time in temperate climates, they 

are exported all over the world, there has been organic bananas, not just for a few days or 

weeks or months or years, but forever and they have been exporting them successfully 

and functionally without this being included in the organic list so I guess that is my 

question, have not we successfully been transporting organic bananas for many decades 

without the use of this partic-, I understand there is a petition on this question so we have 

to answer it. But I just, it seem like we are already doing it successfully without this and I 
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46

think you gave some exam-, or the, the commenter gave some methodologies that people 

manage that it is unnecessary so I am wondering about the conclusion of recommending 

that we, you know, want to support it is confusing to me. 

Zea Sonnabend: Well, keep in mind, we made the recommendation before we received the public 

comment so the recommendation is on the floor, but we have received public comment 

now. The question that you asked is the key question, but we do not have an answer, I do

not think all of us, but we might want to direct that question to people who do give public 

comments on that topic. 

John Foster: Calvin.

Calvin Walker: What was, what was the sample size from OGC? And what areas did they take 

that from? 

Unknown Female: Six million pounds.

Calvin Walker: Six million pounds? 

Zea Sonnabend: Okay. They had 6 million, six million pounds of bananas primarily grown in 

Mexico supplemented by fruit grown in Ecuador and Peru. And someone from the, will 

be giving public comment on behalf of that organization. Question? 

John Foster: Jay.

Jay Feldman: Thanks, Zea. I am glad we are going to listen and hear from those who have 

experience on the essentiality of this because I appreciate your question, Colehour. I 

think it gets to the root of obviously a key issue that, that goes to our review process. So, 

here is where I think we need to come at this from and that is where we have data that 

shows the lack of essentiality. I would think it was the burden of the petitioner to show us

essentiality. In other words, we would always like to have more information. Obviously,

that is a challenge. But in a situation like this where a producer/distributor has 

information for us and we do not have any countervailing information, I think the burden 

is on the petitioner to show that, in fact, there is essentiality and, you know, – [cough] 

excuse me – and this does [cough], this does raise the issue of how do we get this 

essentiality information at the front-end of our review process. I know it is a difficult 

thing to get, but I would hope we would have a bet, a mechanism to do that.

Zea Sonnabend: Yes, it is lacking in many technical reviews. You do have to keep in mind, six

million pounds is probably less than Whole Foods alone sells in a year. I mean that is a 

drop in the bucket of the amount of bananas that happens. So we have only heard from a 

small segment of the industry and maybe there are some other commenters here today. 

We will see. 

Jay Feldman: Yeah. The other question I had is around the alternatives. Could you, I did not

quite catch your comment on refrigeration. Is, are you saying that is not a – and then I 
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47

have one other question about the solvents – but are you, are you saying refrigeration is 

not practical or...?

Zea Sonnabend: Well, bananas cannot be refrigerated, no. 

Jay Feldman: Oh, that is true.

Zea Sonnabend: But for citrus, that was for citrus and citrus can be refrigerated. 

Jay Feldman: Okay. Thank you. On the solvent issue, the way I understand things stand now, we 

have the authorities aboard to address the solvent issue when we are reviewing a material. 

We have done that, obviously we did that with the annotation on hexane. Do you know 

what the solvents are and could we annotate around solvents that we find to be 

problematic? 

Zea Sonnabend: I suppose theoretically you could, but I do not doubt if you have enough votes to 

do that right now when the classification of materials policy is yet to come out to clarify 

the solvent issue. 

Jay Feldman: Okay. Well my point is we have been doing solvent annotation. Not just us, but 

previous Boards. So I think it is appropriate for the Committee in doing its review to ask 

the question about solvents and at least bring that forward as a possibility for annotation. 

The other issue I think you know inerts, no one is surprised to hear me raise the issue of 

inerts, right? You know the Crops Committee has put on hold a lot of proposals for inerts 

in List 4, pending the completion of the policy. I, it is, I feel a little uncomfortable having 

kept those petitions on hold and allowing something like this to, to move through. So, 

yeah, those petitions were for individual inerts, I understand that. But you know in this 

case, where we have a policy pending analogous to the issue on solvents, which I am not 

sure I buy, but where we have a policy pending like this we, we need some consistency 

and the Crops Committee has chosen not to add List 4 inerts pending a policy and I 

would hope we could do that across the Board. But is the problem here that this simply

cannot be used without the inerts, is that correct? 

Zea Sonnabend: Yes, all formulations of gibb on the market contain inerts. We already have an 

inerts policy for crops and this is consistent with that inerts policy that we currently have. 

It will be switched when we have a different inerts policy if this passes. 

John Foster: Thank you. Other questions? Other voices? Alright, thank you. Moving on to 

inositol. So I started on that. So two things here. One, the public comment for inositol 

mirrored pretty closely that for choline. And Zea did such a great job of encapsulating 

that and I conveniently noted that choline was ahead of inositol. 

Sorry. Question? Oh! I am sorry, I went out of order. Lisa, would you please introduce 

inositol?

Comment [JMS14]: 03:15:00
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48

Lisa Brines: Absolutely. Yes, the next substance under consideration is inositol. There was a

petition submitted in July of 2011 by the International Formula Council and it is 

requesting inclusion of inositol at Section 205.605 of the National List as an ingredient to 

be used for nutrient fortification of infant formula. In support of its review, the Handling 

Subcommittee received a third-party technical report which addresses the criteria under 

OFPA. In their consideration of the petition and the technical report, the Handling 

Subcommittee was able to evaluate the substance and come up with a proposal. Both the 

proposal, the petition, and the technical report were posted on the NOP website and 

available to the public in advance of the opening of the public comment period for this 

meeting. Written public comment, as John said, was received on this substance. And the 

petitioner is signed up for in-person public comment. And for this petition, the

Committee will need to take two votes, first for the classification of the substance and a

second vote for listing. Thanks. 

John Foster: Thank you, Lisa. My, again, my apologies for going out of order. I was just so 

excited. So, yes, fortunately for me, Zea did a, a great job of, of covering public comment 

and, and almost word for word, the comments for inositol were, were the same as 

choline. A slight difference in, in that for choline there is some, some documented 

deficiencies in some population subgroups that has not been documented for inositol as 

far as we could find. In general, I, in public comment we were roughly four to one in 

favor, although that was a, a qualified in favor similar to choline that infant formula was, 

was fairly well uniform, there was some dissent but, but for the most part pretty good 

consensus from comment that it should go into organic, should be allowed in organic 

infant formula but also the same concern over the “made with organic” claim as Zea 

described with choline. Actually that is, that is, it is very similar that all the comment, all 

of the discussion was almost mirrored, like I said, word for word on, on this. So I am 

going to, in the interest of saving a little time, we are going to [inaudible]. Yeah.

Zea Sonnabend: One, one teeny difference, though. I think, I did not do a literature or an Internet 

search of which foods are high in choline on their own. It may not be the same list of 

foods, I mean high in inositol, same foods might not be high in inositol as are high in

choline. 

John Foster: The, some of the same foods are. Not, it is not exactly a mirror but it is close, 

including that of breast milk and all the things you spoke to in that, in that case. The other 

little significant difference I forgot to mention was that choline is considered essential by, 

by groups and, and inositol is not. So, Jay, did I see you had your hand up?

Jay Feldman: Yeah, I guess this pertains to inositol and the one you were talking about, choline. 

Are there non-synthetic? Well, you mentioned that, that choline was not, did you say it 

was non-synthetic? 

Zea Sonnabend: When, when it occurs in food, it is non-synthetic. 

Jay Feldman: Right.
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49

Zea Sonnabend: But the petition things are synthetic.

Jay Feldman: Okay. So were there no non-synthetic forms of choline that could be added to...? 

Zea Sonnabend: There are foods. [inaudible]

Jay Feldman: No, I know, but are there, was there a finding of ... 

Zea Sonnabend: To my knowledge, there is no choline extracted from food that is used as a 

supplement. 

Jay Feldman: Right. And in terms of the FDA requirement is, does that pertain? My 

understanding was that pertained to non-milk products as opposed to milk products in 

terms of the, you know, the FDA allowances and the FDA finding. Do I have that right or 

is there...?

Unknown Female: Yes, [inaudible].

Jay Feldman: So we are talking about allowing this in milk products, right? Why the distinction 

there? What...?

Zea Sonnabend: I did not say that, but ...

Jay Feldman: Oh, I am sorry. 

Zea Sonnabend: Although it is not required in milk-based products, cow and sheep and whatever 

milk is still lower than human breast milk in choline and we felt that it would be 

worthwhile to fortify for people who cannot choose their own foods and also to make, it 

is much easier to understand if all infant formula is allowed to have it in it than only...

Jay Feldman: Right, I mean, I heard that. I am just, my question, maybe I was not clear enough. 

Why would you, why would we distinguish ourselves from what FDA requires? What, 

what is the basis for that? 

Zea Sonnabend: What I just said is the, our reasoning for [inaudible]. 

Jay Feldman: So just because we believe in sup, supplementation or...? That goes beyond what 

the FDA thinks is necessary.

Zea Sonnabend: For that case, particular case. 

Jay Feldman: And is there science to support that? I mean, where, what are we citing?

Zea Sonnabend: There is, there is science to support that there is not enough choline in milk 

compared to human milk and that you cannot, there was one suggestion that you just put 

more lecithin in.
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Jay Feldman: Right.

Zea Sonnabend: There is well-established research that you cannot put enough lecithin in to 

make up the difference. Just technically you cannot. 

Jay Feldman: See this, you know, this is the road that people were worried about when we heard 

testimony on DHA that we are, we are going down this road of supplementation in

organic that goes well beyond what the FDA has deemed is required and necessary. And I 

understand people may want these things in their diets but I think as a organic community 

we have to, we have to have a little more before we just putting, just start putting all these 

things in as supplementation. I realize that is a personal opinion but I think at least we 

should have clear documentation on the science that really says to our Board, this is why 

we disagree or believe that the FDA standard is not sufficient and therefore we are 

allowing this additional supplementation that the, the agency itself does not deem 

necessary. 

Zea Sonnabend: What would you like beyond the research paper that says you cannot add 

lecithin and the amount of choline in milk? I can provide you with those figures. 

Jay Feldman: I, I get a lot of good information when I shop at Whole Foods or other, you know, 

Safeway or my local Co-op about things I can do with cooking and diet and so forth, 

where I can get other sources of these nutrients and that is where I think all lot of people, 

you know, what I am hearing is a lot of people in the organic community believe we 

should be at as a community. We should not be putting all these synthetics into our food 

to supplement what we can get through other means in this very same store which we 

shop.

Zea Sonnabend: But that, that is our whole point. You can choose what you eat. A baby cannot 

choose what it eats. 

Jay Feldman: Yep. The, hopefully, the parents can be educated. I mean that is the whole point 

here.

Zea Sonnabend: A parent cannot go to Whole Foods and choose like different foods for an 

infant. It is either breast milk or formula. 

Jay Feldman: Well, then I will ask the same question Colehour asked in a different context. Is 

there an identified deficiency that the FDA has identified that would put this on a list of 

required supplementation for meeting nutrient needs of, of infant development? And I 

just do not see that anywhere. I just, I need to see that to be able to support something 

like this. 

John Foster: Alright. I have got Colehour, then Jean.
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Colehour Bondera: I, I guess my question, and I apologize I that did not do it when we were 

talking about choline, I, I was not thinking fast enough. But it, it applies to these, them 

both and it is actually more of a logistical question of layout. And I think that Zea might 

have just alluded to the response but it is still a little bit unclear to me. The way that these 

are presented as two separate listing motions and one of them is specifically the infant

formula component and says “labeled organic” or “made with organic”. And then that, 

that is the first listing motion in both cases. And then the second listing motion – and now 

I have to go back and forth – but in both cases is agricultural products other than infant

formulas and then just labeled “made with organics”. And I get concerned and confused 

that we are going to, and I am not saying this is your goal or point, but mislead the 

parents of infants, that those things are organic because they are for infants but the same 

exact thing, if it is for an adult, we are not going to call it organic, we are going to say

“made with organic”. And I just do not get the, the exact rationale as to why, when we 

are talking about the same exact things, but all we are differentiating is adult versus 

infant, and it is required for the infants therefore we are going to call it organic but it is 

not required for the adults therefore we will just say “made with organic”. That is how I

am reading these differentials and it is confusing to me and I would like to hear a little bit 

more as to the rationale I think.

Zea Sonnabend: The rationale was there in our summary of, of our recommendation. It is so you 

have a choice to vote for one motion and not the other if you feel that you would like to 

comply with the FDA requirements for infant formula but you do not think it belongs in 

adult food at all. You can vote yes on one and no on the other. If the motion for infant 

formula fails, you could put in a substitute motion for just non-milk-based infant formula,

for instance, to separate it out even more. But we believe to put, we decided to put 

forward the choice of the “made with” for adult food in case it, people on the Board 

thought it was a good idea that such foods could highlight the fact they are fortified but at 

the same time, and contain some organic ingredients, but at the same time limit the 

number of non-essential synthetics in organic processing. So, you know, vote yes for one 

and no for the other, or vote no for both of them, but we, we thought it, they were 

different enough issues, they should be two different motions. 

John Foster: Thank you. Jean? 

Jean Richardson: When I look at the inositol, it, it appears that there is a non-synthetic form that 

could be used in place of a synthetic form when I read the, your, the, the wording in the, 

in the document. Should I address this to John or Zea? Sorry, but this is on inositol. But 

the, where going... We would be voting to support synthetic addition, synthetic version 

of inositol into the infant formula because it is more commercially available than the nonsynthetic. And so I would like some clarification on that, you know, because I sort of hate 

to see us putting in a synthetic into a, you know, into infant formula with, when we could, 

in fact, be encouraging the use of a non-synthetic. I understand the commercial issue but I 

wonder if you would address that on your Committee?

John Foster: We did. And if the phrasing in the, in the proposal is confusing, I apologize. That 

was my fault. The, the idea, what I was trying to convey, was that while inositol is a non-
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52

synthetic originally in all of the sources we were talking about ahead of time, the sources 

that are available for this kind of supplementation are synthetic. 

Jean Richardson: And are there no non-synthetic versions of it that could be used in infant

formula?

John Foster: Similar to choline – Zea, correct me if I am wrong – well, “none” is, I do not know. 

I, I try to stay away from “always” and “never”, but they were, they were not in a, they 

did not appear to be commercially available such that they would be useful to the, to 

manufacturers. That was my, that is what I could find anyway. Zea, was that the same for 

choline? 

Zea Sonnabend: [inaudible] I do not remember what the inositol TR said. I am looking for it 

now, but a lot has come and gone since I looked at that TR. 

John Foster: Okay. While Zea is looking at that, are there other questions? 

Unknown Male: [Inaudible]

John Foster: Jay?

Jay Feldman: Did you guys look at the extraction issues again here? Did that come up at all? 

John Foster: For both, both you mean?

Jay Feldman: Both are the same extractant?

Zea Sonnabend: They are not extracted. They are just totally chemically synthesized. 

Jay Feldman: Okay.

Zea Sonnabend: Well, I do not know about inositol once again I [inaudible]. Choline is just 

totally chemically synthesized.

John Foster: Tracy. 

Tracy Favre: Yeah, according to the TR it says inositol is not available; non-synthetic production 

methods are not available for use on commercial scale.

John Foster: Thank you, Tracy. 

Zea Sonnabend: And we will look at the extraction method too while we are at it. 

John Foster: Alright, I am feeling like I want to kind of wrap up inositol. Is it alright if we get 

back on the extraction after? Is that alright, Jay? Okay. Alright, moving along to citrus

Comment [JMS15]: 03:30:00
Meeting Of The National Organic Standards Board

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53

hystrix. Here is another one where, oh, I am sorry. God dang it. Lisa, would you be so 

kind? 

Lisa Brines: We will get his down by the end I think. 

John Foster: Thank you.

Lisa Brines: So the next substance under consideration is citrus hystrix, also known by its 

common name Kaffir Lime leaves and fruit. Petition was submitted in August of 2011 for 

inclusion of citrus hystrix into section 205.606 of the National List as a non-organically 

produced agricultural product allowed as an ingredient in or on processed products 

labeled as organic. The petition was submitted by the company Curry Love Incorporated, 

which is the same petitioner that submitted the petition cur, for curry leaf which is under 

consideration at the meeting as well. The Handling Subcommittee did not request a 

technical report for this petitioned substance, but using the petition they were able to 

complete its evaluation according to the criteria under OFPA and the NOP regulations, 

and have issued a proposal. Both the proposal and the petition were posted on the NOP 

website and available to the public in advance of the public comment period opening for 

this meeting. Public comment has been received on this substance and the Board will 

need to take two votes, the first a classification decision and second a listing motion. 

Thanks.

John Foster: Thank you, Lisa. So you, you will notice on the, the prior 606 addition, I did not 

talk about public comment because I will do that all one, all as one now. The comments 

for curry leaves and the comments for citrus his-, hystrix are, are lock-step together. 

Petitions, petitioner was the same. The lack of at least readily available market data was 

the same, the essentiality, leading to the essentiality question. The importation had 

similar concerns. The, in general, public comment was in favor of it. There was an, an

articulate question I think in, in one public comment about the essentiality, which I, I 

imagine we will get to it in discussion when, when that time comes, same as, same as for 

the curry leaves. Again, we did not ask for the TR based on its at least apparent nonsynthetic status to us. And I, actually everything else is the same. We had a handful, not 

many, not many comments. We did the same kind of literature review on, on availability, 

found the similar findings. Questions? Jay.

Jay Feldman: I just want to raise an issue that came up while we were looking at this which, 

which I had not thought about before but, because of the importation issue here and 

quarantines that are in effect by APHIS and the use of materials that we would not like in 

terms of fumigation and that, that sort of thing. I just raise it because it raises an issue of 

production and it raises an issue outside the scope of the Program but gets to more 

sensitivity on the part of APHIS to identify alternative fumigation or quarantine 

procedures that are more in alignment with organic. And we have seen this historically 

happen with mangoes, for instance. I mentioned this previous Board meeting where they 

went from, you know, ethylene dibromide fumigation to hot water dip. And to the extent 

that we as a Board can encourage quarantine practices that are not heavily relying on 
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54

toxic chemicals, especially when we are allowing those crops to be used as ingredients. 

You know what I am saying? That would be really helpful down the road. 

John Foster: That is a good thought. I, I do not know if it is going to make it to the, the top of the 

list of research priorities but that certainly, it sounds like that would be an appropriate 

way to look at it. It also sounds like a good maybe master's thesis for somebody out there.

Colehour, question?

Colehour Bondera: Yeah, I, I guess I am not intending to add to what Jay said, but you know

both of these items, Kaffir Lime leaves and curry leaves, grow quite prolifically and 

easily in Hawaii. I am not aware of anyone who is producing them commercially. I do at 

my farmer’s market sell Kaffir Lime leaves all of the time to customers. So I, I think that,

you know, I am not familiar with the, you know, USDA rules and processes on 

importation and transportation of those within the United States and Hawaii, to, you 

know, I am not familiar with those. But I think that the issues that Jay raised are the 

critical issues because it is not as if these things could not be readily produced at an 

organic scale without any difficulty. 

John Foster: Sounds like you need to get planting. Jennifer? 

Jennifer Taylor: [Inaudible] I would like to add that the Kaffir Lime is, the farmers grow it in 

Florida and it is grown and they sell it in the market as an organically grown citrus. So 

there, there is a possible market for it. 

John Foster: So, those did not come up on, if – I do not know how to say this – so if they are 

being represented as organic, they are not readily coming up on any of the searches I 

could find. So, may want to look into that. But also, this, you know, this, prior Boards 

before us have, have noted that 606, I think Joe Smiley was probably the, the biggest, the

speaker to this most often, was that this should be the list of, of products that growers 

ought to get involved with and that, that was part of the intent behind having a list and I 

think it, it still could be a very positive way to, to get more ground in organic production. 

Zea, you had a question?

Zea Sonnabend: Yeah, I wanted to supplement what you just said last by saying that all of the 

commercial availability clauses are aimed at handlers trying to source commercially 

available organic ingredients but there is no backward line of communication for a 

grower to know what to plant that there might be a market for without putting something 

on this list. And this list would give notice that these are things that are being looked for 

in the industry. And while I have very ambivalent feelings and do not really feel qualified 

to assess the market on any 606 items, but I do feel that that is one real reason to consider 

some of these additions and keeping that in mind that this is a way for growers to know

what there might be demand for. 

John Foster: Other questions or discussion? Alright, I believe that is the last petition item on this 

time around. Moving on to Sunset determinations. Lisa, would you be so kind? 
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55

Lisa Brines: Yes, thanks, John. So the first Sunset material under consideration is agar-agar. It 

was originally reviewed by the NOSB in April of 1995 and added to the National List 

with an effective date November 3rd, 2003. We, it was renewed under a Sunset process in 

2008 as well. So the current listing reads as follows, it is included at section 205.605 as a 

non-agricultural, non-organic substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic” specified ingredients or food 

groups. It is under (a) non-synthetics allowed as agar-agar without annotation. Its current 

Sunset date is November 3rd, 2013. In support of its review, the Handling Subcommittee

did request additional technical information to assist in its review. So there is two pieces 

of technical information available. There was a new technical report that was developed 

in support of this Sunset review which is posted on the NOP website. And there was an 

also an old Technical Advisory Panel that was conducted in 1995. And both of those 

reports are available on the NOP website and were available in advance of the opening of 

the public comment period for this meeting. So the Committee was able to conclude its 

review against the criteria under OFPA and NOP regulations and issue a proposal. And 

that proposal was also available on the NOP website in advance of this meeting. In terms 

of public comment, public did have the opportunity to comment in advance of this 

meeting and in an addition to that, the Program had published an advance notice of 

proposed rulemaking in June of last year to announce the Sunset 2013 materials. And that 

NPR had a 60 day comment period as well. Thanks. 

John Foster: Thank you, Lisa. Harold, I believe this was in your court. Would you be so kind? 

Harold Austin: Thank you, John. The Handling Committee at this time would like to modify our 

recommendation based off of public comment. And that would be, the, our 

recommendation would be to relist it as previously stated without the modifications that 

we had submitted in February. So that we would be recommending to relist it under 

205.605 non-agricultural, non-organic substances allowed as ingredients in or processed 

products labeled as “organic” or “made with organic” speci-, specified ingredients or 

food groups (a) non-synthetics allowed. Originally, why we had recommended making 

some changes and we were going to ask that it be listed based off of the TR and the, the

extraction processes – we did look at those, Jay – and it, we looked at the TR 

information. It does, it did have a tendency to make us think that there was some 

modifications taking place to the product itself. But based off of the public comment, a 

lot of public comment was giving us some pretty good feedback that at this juncture, we 

should not recommend making a change until the draft guidance that was submitted to the 

NOP in 2009 becomes final and then we can use that. They felt that we would be setting 

precedents and the Committee agrees with that. So we are going to list, we, we are going 

to, we move to as a Committee or recommend it that we go ahead relist it as it originally 

was. 

This is a, a seaweed-derived polysaccharide. It has been classified GRAS by the FDA

since 1972. It is world, it is recognized around the world, originated, originally used in 

Japan in the 19-, 1650s, recognized by the FDA, CODEX, a commission of the European 

Union, the Canadian General Standards Board, IFOAM, as food safe. Its primary use is 

as a, a stabilizing agent, a gel, a gelling compound, used in bakery goods, used in
Meeting Of The National Organic Standards Board

May 24, 2012

56

products such as yogurt, some dairy, some dairy goods. There are alternatives to this but 

based off of public comment, there are some unique characteristics with the product that 

is derived from agar that has a, a very high loop between cooling and heating so that 

especially in bakery goods, it makes it a, a very unique material that is not have another 

alternative to replace it with.

On the TR, well okay on public comment, on the ANPR, the advanced notice of proposed 

rulemaking that ended August 1st, 2011 there were several comments that were in favor 

of relisting it. There were none that were opposed. On our just recently ended public 

comment, there were a handful of comments that were in favor of relist, relisting, one 

opposed, primarily based off of the fact that there were other alternative materials out 

there that could be substituted. But based off of the additional public comment that we 

saw, that although there are alternatives, there are not alternatives that meet this specific 

need especially in the bakery goods and in, in some of the products like yogurt and stuff. 

So that is why I think we have looked at it and we have gone into our proposal of support 

to move it to relist it.

John Foster: Thank you, Harold. Question from the Board? Jay.

Jay Feldman: Thanks, Harold. I am wondering if you could just repeat, because I, I am not sure I 

followed what changes you were making to the original [inaudible].

Harold Austin: Okay, our original amendment, or our original recommendation, Jay, was to, we 

were going to propose, I will just read it to you. At this time, we would, we recommend 

that the relisting of agar-agar as it currently is listed on 205.605(a) as a non-synthetic 

allowed but based off of the information from the TR then we also recommended an 

additional listing of agar under (b) synthetics allowed. We have since retracted that and 

we are going to go back to the original recommendation of listing. So that we are going, 

we are going to strictly list it under 205.605(a) non-synthetic allowed. The one comment 

that I will put in there though is that we would also recommend that the listing be revise, 

revisited once the NOP has finalized a draft guidance for materials classifications. This 

would help to ensure that the materials have been properly classified and thus remove any 

further confusion from their status and help with future reviews. 

John Foster: [Inaudible] Oh, question?

Jay Feldman: Okay, can I follow-up to that? 

John Foster: Follow-up. 

Jay Feldman: Thank you. Okay. So basically the Handling Committee has decided that we are 

not going to follow the material classification policy as it was adopted by the Board, 

which we have been doing since the materials classification policy was adopt, excuse me, 

adopted. I guess that is how I am interpreting this because we have used and struggled

with the definition of class, chemical change on a whole bunch of listings and what we 

are still going to have to do that under new petitions, and the way we have operated, as I 

Comment [JMS16]: 03:45:00
Meeting Of The National Organic Standards Board

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57

understand it, is to apply the policy that the Board adopts rather than waiting for the 

guidance to come out. We, we have done that on a whole series of material. So you are 

now, you are, you decided as a Committee I guess that we are going to wait on a policy. 

Is this just for Sunsets? Or it is...? How are we going to apply that thinking to petitions? 

What policy are we going to use for that? 

John Foster: The other Committee members, please chime in if you want, but the thought was 

stick with the existing classification as it has been. And it has been what it is for a while 

and if I am remembering it wrong, please correct me, but and knowing we had 

clarification coming, it seemed to be consistent with wanting to keep things moving 

forward. There were not a whole lot of other concerns that, that told us this had to be 

changed right now. 

Jay Feldman: Okay, so in terms...

John Foster: Hold on. Hold on. 

Jay Feldman: This is Sunset.

John Foster: So that, so that we, we have faith that we are going to get that clarity. That is also 

why we added the portion of revisiting once that clarification comes, comes through. 

Other Committee members, am I, am I on or no? 

Harold Austin: No, I think you are on, John. I think, Jay, one of the reasons why we opted to take 

and go back to the original recommendation of listing as it existed was that we, because 

we knew that the draft guidance was coming, we did not want to take and because I think 

you have, you have made the comment of the extraction process. And it is a very 

confusing, very complex scenario that takes place and it is up to indiv-, a lot of it is up to 

individual interpretation. And we did not want to set a precedence by stepping out of 

something that has already been reviewed, already been listed in a, in a specific position,

and then all of a sudden in the twelfth hour we are changing it. We felt that we would 

wait until the draft guidance became, it became a rule and then look, look to that 

clarification if we needed to make any, any changes in the future. And that is why we 

added that last statement that in the future, once we had an official rule that was in place,

then we would revisit, then possibly revisit it at that time.

Jay Feldman: Just one clarification. I, I will finish on this. So are we, does that mean we are 

going, you expect the Board would take this up at the point because we are issuing a fiveyear relisting. Would we take it up prior to that five-year relisting, or we would take it up 

again at the end of the five years’ Sunset?

Harold Austin: You know I think that is really up to the Board to decide but I think it is, it is 

really when we see that, that final rule back to us, how that looks, and the verbiage that is 

in it, then we can to make that determination on it on a, at that time. 
Meeting Of The National Organic Standards Board

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58

John Foster: That was our thinking. Also to not just, you know, look at this but all the other 

similar products, some of which are 605(a), some are 605(b), some are 606 and using that 

clarification to hopefully align all of those at the same time would be, would be the hope. 

And I think that, that serves, I think that serves everybody actually. Yeah, Zea did you 

want to, did you want to add anything? Okay. Jean, and then Mac. 

Jean Richardson: Generally I do not have an issue with approving the agar-agar going forward. 

However, I, I would like to know if the Committee, since this is going to be for another 

five years, I would like to have some reassurances that the Committee looked at the 

extent to which this red seaweed is in anyway being over harvested. Because we know 

with other species, like in the Brown Laminaric Group, there is considerable 

overharvesting for other reasons. So did you look at that issue? 

Harold Austin: We did look at that issue. From what we could see at this point that does not 

seem to be an issue but it is definitely something that needs to be, you know, for future 

needs to continue to be monitored. But there was nothing in the TR report or anything 

else that we, we researched to show that there was any negative effect on the biodiversity 

of, of the surrounding areas and beaches.

John Foster: Then I had Mac.

Mac Stone: When you all are evaluating this, investigating this, did it ever come up why is it 

“agar-agar” and not just “agar”?

Crowd: [Laughs]. 

Harold Austin: That one I cannot answer. 

Jean Richardson: Actually it is agar-agar. 

Crowd: [Laughs]. 

John Foster: Po-tay-to, po-tah-to.

Crowd: [Laughs]. 

John Foster: Any last questions, anybody? Alright. Thank you. Next on our list though is calcium 

sulfate, is another Sunset item. Lisa, would you be so kind? 

Lisa Brines: Thanks, John. Yes, the next material under consideration is the Sunset listing for 

calcium sulfate. It was originally reviewed by the NOSB in September of 2000, I am 

sorry, September 1996 and there was a petition for this substance in November of 2000 as 

well. The substance was originally added to the National List effective November 4th,

2003 and was renewed under the Sunset process in 2008. The current listing is on section 

205.605 as a non-agricultural, non-organic substance allowed as an ingredient in or on

processed products labeled as “organic” or “made with organic” specified ingredients or 
Meeting Of The National Organic Standards Board

May 24, 2012

59

food groups. It is under (a) non-synthetics allowed and reads calcium sulfate, mined. The 

current Sunset date is November 3rd, 2013. In support of its review, there was not a new 

technical report developed for this review. The most recent technical report was from 

2001, and that was available on the NOP website in advance of the opening of the public

comment period. So in addition to the public comment period for this meeting, the 

substance was also included in the advanced notice of proposed rulemaking that was 

published in June of last year with a 60 day comment period. And as a, I guess, for this 

particular substance and for all Sunset substance, the Committee really just needs to make 

the one vote, the listing vote, since these materials have been previously classified unless 

changes are being considered. Thanks.

John Foster: Thank you, Lisa. Joe, I believe this was yours. Would you be so kind? 

Joe Dickson: Thank you John. Calcium sulfate – let me just get my ducks in a row here – is 

currently listed on 605(a) as calcium sulfide, mined, which restricts the, the use to the 

mined form instead of the synthesized form. It is used primarily as a coagulant in tofu 

production and it has a long, well-documented history of use in that function. There are a 

few other documented uses in beer brewing and various baked goods for a couple of 

different reasons. From the commenters we heard from for this meeting, three 

organizations, Quality Assurance International, Wolf and DiMatteo, and the Soy Foods 

Association of North America, supported relisting noting its extensive use in tofu 

production. Beyond Pesticides proposed or they supported relisting with an additional 

restrictive annotation to read “for use only as a coagulant in bean curd, tofu and similar 

products”, basically, you know, restricting the use to tofu production only. The Handling

Committee has not had an opportunity to consider that proposal but will before the vote is 

taken. My concern there, of course, would be that it, it may currently be in other uses that 

we did not hear about because the annotation was not in the published proposal. Those 

were the only public comments we received about this material. Any questions or 

discussion on that substance? 

John Foster: Alright. Thank you, Joe. Next on the list, another po-tay-to/po-tah-to: carrajeenan or 

carrageenan. I hesitate to say, let's call the whole thing off. But, but Lisa, would you be 

so kind. 

Lisa Brines: Yeah. Thanks, John. I will use the hard “g”. Thanks.

John Foster: Alright.

Lisa Brines: So the next substance under consideration is carrageenan which was originally 

reviewed by the NOSB in April of 1995. It was added to the National List effective 

November 3rd, 2003 and renewed under the Sunset process in 2008. The current listing 

reads as follows. It is included at section 205.605 on the National List. It is a nonagricultural, non-organic substance allowed as an ingredient in or on processed products 

labeled as “organic” or “made with organic” specified ingredients or food groups. It is 

under (a) non-synthetics allowed and listed just as carrageenan without annotation. 

Current Sunset date is November 3rd, 2013. In terms of the technical information 
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60

available, the NOSB Subcommittee, Handling Subcommittee, had requested a new 

technical report in support of their review of this Sunset substance. So that technical 

report was developed and was posted on the NOP website in advance of the opening pot, 

opening of the public comment period for this meeting. In addition to this new report, 

there was an old Technical Advisory Panel report from 1995 which was also posted on 

the NOP website. So the Committee did it, was able to complete its evaluation of this 

Sunset substance and the proposal was again posted for public comment in advance of 

this meeting. There was a lot of public comment received on this substance in advance of 

this meeting. In addition to this public comment period, this substance was included in 

the advanced notice of proposed rulemaking that the Program published in June of 2011 

and that had a 60 day comment period. Thanks. 

John Foster: Thank you, Lisa. And Harold, I believe this was your material. And let me just 

preface this by saying, sometimes you eat the bear and sometimes, well, the bear eats 

you. 

Harold Austin: You know and when John gave me this one, he told me this was really a simple 

deal. 

Crowd: [Laughs]

Harold Austin: You know, it is a review, it is up for Sunset. You know, no problem. Yeah, right.

Okay. Yeah, it is, we got a lot of comments, alright, to go with it though. Our original 

proposal, again, we have chosen, the Handling Committee has chosen to modify, partially 

because of the same rationale behind what we use in agar-agar waiting for the final draft, 

the draft guidance to become a guidance document to give us an idea of definition, 

definite how to handle some of the compounds and some of these issues when we are 

dealing especially with the areas of extraction. So our modifications would be, first, we 

would like to go back and recommend that we relist it under 205.605(a) non-synthetic 

allowed. Our posted recommendation was going to break that down into 605(a) nonsynthetic allowed and (b) synthetic allowed. And we are going to retract that part of it. 

The additions that we will make to try to take and help deal with some of the public 

comment, which was a lot, would be the verbiage that we have implemented into the 

original recommendation would be: after further review of public comment and commit, 

Committee discussion, the Handling Committee during its the May 9th, 2012 Handling

Committee call has voted to make the following changes to the recommendation on car, 

carrageenan: To relist it as currently listed under 205.605 non-agricultural, non-organic 

substances allowed as ingredients in or on processed products labeled as “organic” or 

“made with organic” specified ingredients or food groups, (a) non-synthetic allowed. We 

would recommend including the follow annotations because there has been some 

concerns raised as to the possible health risk from the use of carrageenan we feel that 

these risks can be addressed by allowing only the carrageenan with the following cast 

numbers to be permitted for use as food processing ingredients or additives. These cast 

numbers would be 9000-07-1 General, 9062-07-1 Iota, 1114-20-8 Kappa and 9064-57-7 

Lambda. 
Meeting Of The National Organic Standards Board

May 24, 2012

61

To further address concerns that have been raised, we would also like to add the 

additional annotation that carrageenan not be allowed for use in infant formulas. Its use in 

foods for older infants older than six months and weaning foods for young children 

would be allowed. 

The rationale and reasoning behind the two annotations are as follows. While there are 

concerns raised regarding adverse health effects caused by the use of carrageenan in 

some studies, most scientific reports tend to agree that the cast numbers that we have 

mentioned are for, for use as food ingredients and have been approved as such by the 

FDA, while carrageenan listed under other cast numbers are not recommended for use in

food production as ingredients or otherwise. 

The reason for the second annotation regarding infants is based on concerns that have 

been raised by the EU Scientific Committee on, on Food, specifically that with the use of 

carrageenan in infant formulas for newborns. The SF, the SCF’s concern is based on facts 

that the Pediatric Nutrition Handbook that, that explains that in newborn infants, the 

neonatal intestine is uniquely capable of ab-, absorbing macromolecules via endocytosis. 

This is the reason why it is recommended by pediatric-, pediatricians not to feed infants

solid foods until they are four to six months old to help prevent food allergies, as printed 

in the Pediatric Nutrition Handbook. The SCF had no objections for the use for older 

infants or in weaning foods for young children. We feel that there are enough scientific 

discussions on this subject that by add, adding these two annotations to our

recommendation that we address concerns, or at least the majority of the concerns raised 

during public comment. 

Public comment was substantial, a lot of comments. You on the Board, the one thing that 

I would, I would make mention of, and I am sure that it is always there, is that there were

a lot of percentage of those public comments that were kind of a canned response, looked

like they were probably originated from one or two sources and, you know, sometimes 

people just do not have the ability to say the words that they think or what they mean, so

they, I mean I, I think it is standard practice. But there were a lot that, that were a just 

simply a canned response. And then there were a lot of others that were from the heart 

that were individuals that making comments. A lot of the responses were raising health 

concerns, regarding this material, as a possible carcinogen, as material that has, would 

maybe cause some intestinal internal irritations and concerns. And I am going to let Zea 

address some the scientific stuff here in just a minute. 

The one thing that I would mention that during the public, a lot of the public comments 

referred back to publications that have been done over the years that I believe the 

individual that drafted those documents is going to be one of our public speakers later on. 

So she will be able to enlighten us a little bit on that. Others have responded to point out 

that there are different forms of carrageenan that in a scientific community that have

where there have been concerns raised. And I am going to let, I am going to fall back. 

There are two specific types of carrageenan. And I am going to let Zea go into the 

specifics on, on the differences between carra-, carrageenan and polygeenan.

Comment [JMS17]: 04:00:00
Meeting Of The National Organic Standards Board

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62

Probably the other area that we had significant input from stakeholders from trade 

associations was that our propose to reclassify. And that was one of the main reasons why 

we chose not to do that at this time until we can wait until the draft guidance comes 

through. Public comment also, from stakeholders also, states that there is definite still a 

need within the industry for the continued use of carrageenan, beer production, whipping 

cream, chocolate pudding, chocolate milk, some characteristics that some of the other 

materials that are available as an alter-, alternative or a substitute, some of the properties 

that they do not have as a replacement or as an alt-, a substitute. This product has been 

deemed as food safe by the FDA, by Canada, by the Joint Evaluation Committee for 

Food Additives.

One of the things that we did see was raised a little bit also in public comment and it was 

mentioned a little bit in the TR was some concerns with the environmental impact, the 

harvesting. There are concerns as the uses continues to grow, that the extraction from the 

sea of the red seaweeds and algaes may have some negative impact on the bi-, on the 

biodiversity of the, the existing area. But that is a complicated issue because there is other 

things being harvested at the same time that also impact that environment, that 

biodiversity. So, looking at the information we have, it is a concern that is out there but it 

is not one that we feel has been substantiated to a level that we would deem it has an 

impact at this juncture. But it is definitely worth noting and it is definitely continuing to 

monitor and look at in the future. That is all I have. Zea, you want to kick in on this one?

Zea Sonnabend: Yes, thank you, Harold. All right I want everyone to put their scientist hat on

because in order to understand this material we really have to delve into the science. And 

I am sure we are going to have a lively discuss-, discussion on these issues this afternoon 

after we hear public comment. But in the way of framing that discussion, I am just going 

to read from a few scientific papers that address some of the basic points of carrageenan 

and then after we hear public comment, we can come back and discuss the merits of, of 

various points of view. Okay. These, these are the discussion topics that I am going to 

address somewhat in this, in this discussion. I am leaving alone the issues of alternatives 

and what happens in the marketplace and just focusing on the parts that are justifiable in 

the scientific literature at the moment. 

And you know I do, while I have my virtual science hat on, I left my real science hat at

home. I had a sci-, sci-, a hat made that said, Miss Information. 

Crowd: [Laughs] 

Zea Sonnabend: But I am not wearing it today so I hope to give you accurate information from 

the literature. Now one thing I found, I delved into the original literature beyond the 

public comment, the citations that were given and some citations that were not given, to 

look at what has been done on carrageenan. These, to boil this down for non-scientists, 

these are the basic questions that we should be asking ourselves as we hear the following 

discussion. What is the difference between un-degraded carrageenan and degraded

carrageenan? What type of carrageenan is in food? Are there environmental issues from 
Meeting Of The National Organic Standards Board

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63

the production of carrageenan? Does – and I started abbreviating after this, but – does it 

degrade in the human digestive tract? Does any form of it cause colitus or inflammation 

in humans? Does it cause cancer or tumors in humans? And whose research is believable 

and which research method, methods might be flawed? Can I have the next page? 

These are the literature sources that I am using for the purpose of this particular 

discussion although I have read many, many, many more than this but I thought that these 

were good for starting off the discussion. The first three I will be reading from rather than 

stating my interpretation of them. And I apologize for those of you not scientists that this 

might be overwhelming and you might get sick of hearing about rat colons by the end of 

this, but that is what science is all about so. 

Okay, from the first reference, which is JECFA, an FAO organization that reviews data 

on food ingredients. This is a review of toxicology literature pertaining to carrageenan 

and processed eu-, eu-, – I do not know how to say that – seaweed published from 1997 

to 2006 by Doctor Samuel Cohen from Nebraska and Doctor Nobuki Ito from Japan. And 

these are excerpts. If I read the whole 69 page thing, I think everyone would be asleep by 

then end but these are excerpts. 

Carrageenan has often been confused with polygeenan. Polygeenan involves a different 

manufacturing process. It utilizes carrageenan as the starting material which is exposed to 

intentional extensive acid hydrolysis at high temperatures over 80 degrees centigrade 

resulting in significantly smaller sulfated galactose polymers with an average molecular 

weight of approximately 15,000 daltons. Though of, of no toxicological significance, 

carrageenan contains a negligible amount of low molecular weight polymers. Depending 

on the analytical method used, the low molecular weight forms are less than 12% of the 

total composition of the commercial carrageenan used in foods. Because carrageenan is 

extracted from seaweed under alkaline conditions, degradation to smaller polymerized 

pal-, polysaccharides is avoided. As long as the pH is maintained above six, carrageenan 

is stable to heat processing. Once carrageenan is in the gel configuration as in the case for 

its use in food systems, the carrageenan becomes highly resistant to degradation even 

under more acidic conditions such as occur in the stomach. Carrageenan ingested in the 

gel form either as homogenous carrageenan gel or one consisting of a carrageenan protein 

gel from meat or dairy is also stable to the conditions of passage through the digestive 

tract – and a lot of citations are given. Based on these broad, basic properties of 

carrageenan, there are several obs-, observations which must be followed in any

evaluation of literature regarding the pet-, potential safety of carrageenan from food. –

And I might add these are basic properties I am about to read as what you also should pay 

attention to in listening to public comments. –

1. Carrageenan is a high molecular weight substance with well-defined specifications, 

a.k.a. purity criteria. 

2. In its commercially utilized form, carrageenan is not degraded in the intestinal tract. 

3. Carrageenan administered in food and beverages is not absorbed from the 

gastrointestinal tract. 
Meeting Of The National Organic Standards Board

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64

4. Studies involving polygeenan, a low molecular weight substance historically referred 

to as degraded carrageenan, and which is produced by the acid hydrolysis of carrageenan, 

are not relevant to the biological or toxicological evaluation of carrageenan. 

5. Experiments using systemic administration, subcutaneous, intra-peritoneal and 

intravenous, this means injection in general, are not relevant to biological or toxicological 

evaluation of orally administered calla-, carrageenan such as food. 

In vitro studies evaluating carrageenan are not relevant to the biological or toxicological 

properties of orally administering carrageenan. The relationship between the molecular 

weight and concentration of the test material needs to be considered. The concentration in 

diet, especially in drinking water, can greatly affect the acceptability of the administered 

stub-, substance by the test animal as well as affecting availability of water and nutrition. 

In publishing a study of the scientific literature, it is essential to fully disclose the 

characteristics of each carrageenan being administered including the type and viscosity, 

the dose and form in which it is being administered, the route of administration, and

evaluation of the specific bioassays being utilized to util-, assess the biological or 

toxicological properties of carrageenan. A comparison to commercially utilize 

carrageenan and polygeenan should be provided. – And that is by each, in each study that 

you are looking or each commenter. 

Okay, from the second reference, The European Commission. Opinion of the Scientific

Committee on Food on Carrageenan. A recent prob-, publication from Uno et al. in 2001 

re-, examined 29 samples of food-grade carrageenan, showed that the average molecular 

weight of these samples ranged from 453,000 to 652,000 daltons. Polygeenan, which 

range from 20,000 to 30,000 dalton, was not detectable in any sample. While this study 

indicates that should any mull lower, lower molecular weight fraction be present in foodgrade carrageenan, it would represent only a small proportion of the material. The

Committee noted that the specification for carrageenan does not exclude the possible 

presence of lower molecular weight material. 

Two studies in rats with known colon tumin, tumor initiators, either azoxymethane or Nmethyl-N-nitrosourea or 1,2-dimethylhydrazine, showed that co-administration of 

carrageenan at 15% or 6% in the diet increased the incidence of colon tumors compared 

to animals treated with incident alone – citation given. Study con-, conducted to a 

classical design for detection of prum-, tumor promotion in which four weekly injections 

of the initiator dimethylhydrazine were followed by 32 weeks of feeding carrageenan at 

concentrations of zero, 1.25, 2.5, and 5.0 in the diet, did not find any increase in the 

incidence of tumors compared to animals treated with the initiator alone – citation given. 

The nominal 5% dietary level gave a calculated mean intake of carrageenan during the 

study period of 3230 milligrams per kilogram of body weight a day. 

The Committee noted that this negativist study was not included in the review by 

Tobacman – citation given. JECFA – which is the publisher of this monograph – review,

an earlier review in 2002 pointed out that the two positive studies using higher dietary 

levels of carrageenan, while negative studies used lower dietary levels of carrageenan. 

The review further noted that since the carrageenan in the positive studies was fed, fed

Comment [JMS18]: 04:15:00
Meeting Of The National Organic Standards Board

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65

before, during, and after the administration of the tumor initiator, the enhanced 

carcinogenesis may have resulted from promotion but could not, also have resulted from 

altered toxico-kinetics or biotransformation of the carcinogen used as the initiator. 

In the absence of any further information on the possible absorption of carrageenan by 

the immature gut of the very young infant, the Committee reaffirms its earlier view that it 

remains inadvisable to use carrageenan in infant formulas that are fed from birth,

including in those categories of food for special medical purposes. The Committee has no 

objection to the use of carrageenan in foods for older adults, older infants, such as followon milks and weaning foods.

Okay, that is all from that reference. But you may be asking yourself if you paid 

attention, what the heck is the comparison between 5% dietary level, 1.25, 3.2 milligrams 

per kilogram? So, I could not find a concise place, although the document discusses this, 

I could not quote a concise thing so I have tabulated that for you from the document. 

Typical human intake is 30 to 50 milligrams per person per day. Studies are often done 

on 5 percent of body weight which gives a mean intake of 3230 milligrams per kilogram 

per day. For a 220-pound person, which is the easiest to calculate because a kilogram is 

2.2 pounds, ...

Crowd: [Laughs]

Zea Sonnabend: ... this would ee-, equivalent to 323 milligrams per person per day, which is in 

contrast to 30 to 50 average milligrams per kilogram today. These levels did not show 

adverse effects in these studies. However, these levels are well, well above average daily 

intake. The levels that did show adverse effects in the other studies were two to three 

times as much as this 323 milligrams per kilogram. 

Okay, next, next reference and this is the last one I will read from. The Durham Research 

Online paper from Burges Watson in 2008. Public health and carrageenan regulations: a 

review and analysis. It is concluded that current assessment of risk associated with 

carrageenan have, in some contexts, failed to take into account the full spectrum of safety 

assessments that have been carried out and the maturing of food additive regulations

thereby allowing a myth of risk to continue. The Scientific Committee of Food from the 

SCF recently endorsed a mess, a molecular weight distribution limit on carrageenan that 

is more restrictive than is the case in the US – citation given. At the same time, the SCF

acknowledges there is no evidence that exposure to low molecular weight carrageenan 

from the use of food-grade carrageenan is occurring. Since 1969 scientific assessments of 

carrageenan included short-term and long-term generational studies, involved different 

dosages of degraded and non-degraded forms, and various animal studies including 

rabbits, rats, mice, rabbits, rhesus monkeys, squirrel monkeys, pigs, gerbils, baboons, 

hamsters, ferrets, chick embryos and dogs – citation given. All of these studies support 

the safety of carrageenan for use in foods. Regulatory authorities saw no reason to 

question the safety of carrageenan as long as the average molecular weight was 100,000 

daltons or higher. 
Meeting Of The National Organic Standards Board

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66

There is also the increased recognition of the potential value of carrageenan for antiviral,

hypocholesterolaemic and hypoglycemic properties – citation given. If current rounds of 

research prove successful, carrageenan will play an important role, part in sexual health 

applications, such as microbicides for HIV, AIDS and use, and can reduce the risk of 

cervical cancers by inhibiting the human papilloma virus – citations given. This diversity 

of possible new uses for carrageenan across different regulatory settings provides a 

complex context for assessing health risks and benefits, but the positive nature of these 

applications will help the public and regulators to understand the potential health effects 

of different products. 

Okay, I will have more to add on the other discussion points after the public comment 

period but I am sure we will get some divergent opinions from public commenters and I 

would like to hear them before we proceed. But are there any questions on what I have 

said so far? [Inaudible]

Calvin Walker: How would you summarize all you have said in scientific jargon? What would 

be your message from research [inaudible]?

Zea Sonnabend: My, I would rather wait for a complete summary until after we hear the public

comment, but in general, what the researchers clay, seem to be squabbling about the 

most, is that the research methods that find tumors and lesions and problems, the research 

methods with those are flawed and the research conducted with what the reviewers 

consider to be good scientific methods are the ones that are the more believable. 

Jean.

Jean Richardson: My question does not directly relate to this, the technical science of it right 

now; relates more to the impact on the marine ecosystems and is this the right time to ask 

the question or not? 

Zea Sonnabend: I think we should wait until after public comment on that, if you do not mind.

Because I think some of our testifiers will have more information that we could get from 

them. 

Harold Austin: Calvin, I think one point to, to follow up on what Zea had just said though, to, to

clarify what her presentation was, that there has been a lot of, in the scientific 

community, there has been a lot of banter back and forth about, about what is, what was 

working, what you know as far as the scientific approach to it, because there are two very 

distinct materials that we are talking about, carrageenan and polygeenan, with very 

distinct, very specific molecular weights that are involved. Based off of what she had just 

said, this is, this was the scientific rationale why, why most of the international bodies 

have deemed this product as food safe. And so, and I think we will find more and hear 

more of this as the public comments begin. 

Unknown Male: [Whispering] Barry, [inaudible] break for lunch and then do these two.
Meeting Of The National Organic Standards Board

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67

John Foster: Yeah.

Nick Maravell: Yes, this is not, not to follow up on your comments, but to Harold’s. I will do 

this as delicately as possible here. I read many of the comments on carrageenan and many 

of them were coming off of a standard type of formula. But I did not find them any less 

heartfelt and I think you may have meant to say more that they were, they did not provide 

additional insight and further, further evidence. But I, I do want to see the comments that 

come from the field and people have different levels of expertise and, and knowledge and

so I think we should characterize them all and assume them all as equal in their intent and 

heartfelt-ness. And I know that is not what you meant. But I just want to clarify that for 

the public that we, we do want to see all comments, big and small. 

Harold Austin: Nick, thanks. And, and yeah, that was, if I came across that I was giving those 

any less credence, that was not my intent at all, I was just, just trying to make it, I guess 

to categorize that there were a, a couple of very distinct groups of comments and that, and

that there were a lot of others. So that, yeah, it was I took nothing away from those 

comments. I just, I am new and that was my observation and I was just trying to put that 

forward. 

John Foster: Nick. Okay, Jay.

Jay Feldman: Than you. Thanks, Zea, really appreciate that reading. I am going to send you 

studies to read to me and you can tape them and send them to my office. 

Crowd: [Laughs]. 

Jay Feldman: So, I mean it is, it is a little difficult to absorb obviously as you are sitting here 

listening to it. But what I got out of some of the public comments was that distinct, 

distinction between high molecular and low molecular weight is somewhat of a false 

distinction because in effect, the, the food-grade, which I pres-, I understand to be the 

high molecular, is typically contaminated by the low-grade, which is the low molecular. I

am sorry, the degraded, degraded carrageenan, which is a low molecular. And so, I guess 

my question is, did the studies that you are citing acknowledge that a high molecular was, 

was contaminated with low molecular, or food-grade was contaminated with degraded 

carrageenan? Did that come up in the studies?

Zea Sonnabend: Contaminated is the wrong word. 

Jay Feldman: Okay.

Zea Sonnabend: But, yes, in some of what I read said it contains a certain percentage of lower 

molecular weight. But there is a big difference between 100,000 daltons and 10,000 

daltons which are the typical weights. And one of the things I read that said, well, a 

hundred thousand daltons is the minimum for food-grade, it can go up between 400,000 

and 600,000. So, they have no, they are arguing a lot and I did not even want to get into it 

because in the end it is not totally relevant. But they are fighting over the scientific 
Meeting Of The National Organic Standards Board

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68

methods to measure how much degradation is occurred extensively. But there is a whole 

range of different degradation, say it is a hundred thousand and it degrades and it goes 

down to 80,000. That, they call that degraded because it is degrading somewhat but it is 

still 80,000. It, you know, there is no conclusive evidence that shows that it degrades all 

the way to 10,000, and that, therefore, it is in there at a level, that the extremely highly 

extracted polygeenan is in there. They cannot tell, you know, they just say it is degraded 

somewhat, well the degradation could be anywhere between any, you know, that whole 

range in between. So it is degraded, the adjective, how much does it degrade and 

degraded the noun, degraded carrageenan.

Jay Feldman: Thanks, Zea. Follow-up: Did the, did the studies look at the metab-, the 

metabolizing of the material in, in the test organism, or in? 

Zea Sonnabend: Yeah.

Jay Feldman: Okay. So it is looking at another issue that I understand to be, to come into play

here is that once this substance is ingested into the body it takes on a different form as 

well. So it is not just a question of what percentage of the food-grade contains a degraded 

form, but it is also a question of what happens to that material when it is metabolized in 

the body. And did these studies look at, look at that mechanism? 

Zea Sonnabend: Carrageenan is extremely well studied. There are thousands of studies. So, yes, 

of course they have looked at it. But whether you, you know, what conclusions can be 

drawn from any individual study compared a whole group of studies, is somewhat 

subjective. 

Jay Feldman: And then finally, John, this is it, in terms of tracking what, you know, sort of 

epidemiology on this, did you guys, you guys did not see, at least in the documents I saw,

did not seem to recognize that there is a proportion of the population that is experiencing 

adverse effects. In fact, one of the, one of the submissions from a respected scientist 

indicated that he himself experienced reactions but was not aware of anything in the 

scientific literature that identified his problem to be widespread and yet I have seen other 

references to the, to the or I have seen other citations that indicate that there is a 

proportion of the public that suffers from an adverse reaction to this.

Zea Sonnabend: I would like to get back to that point after lunch and after the public comment, 

because I do have something to add but it really was not part of the introductory material. 

Harold Austin: Zea, and that I think there was another, actually another written submitted public 

comment that was from one of our original Board members that, that was part of the TAP

that has an allerg-, an allergic reaction to carrageenan but he also recommended 

continuing forth in listing this material. 

John Foster: Thanks, Harold. Last questions? Calvin. 

Comment [JMS19]: 04:30:00
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69

Calvin Walker: How would you characterize the public comments? You mentioned that it was 

substantial. Would you say it was substantial for or against? 

Harold Austin: I think from the individual comments coming in, it was definitely against listing. 

Quantifying that, part of it I think was based off of documentation that was presented that 

I think Zea is wanting to address maybe at a little bit later date, little later point in time 

after we have had some public testimony. There was a, a lot of stuff that was submitted 

also, Calvin, that was basing, and, and it goes back to this commentary that I made earlier 

about the, the back-and-forth within the scientific community about some of the studies 

that are being used to substantiate the, the negative impact of the carrageenan. And so I, I

think as we go into public comments this afternoon, a lot of these types of questions, I 

hope for all of us will get clarified and cleaned up so we can, we can make a, a good 

honest vote on, on a true, a true feeling. 

John Foster: Alright, thank you. I think, I have been, through an intermediary, communicating 

with the Barry on wanting to stick to our lunch schedule which I believe is right about 

now that would mean that we would come back to cover glucono delta-lactone and 

cellulose after lunch and then go straight into public comment. Barry, is that, is that 

alright with you? 

Barry Flamm: Yes, I, I think we should take a break for lunch now, a one-hour lunch break, that 

would put us back here about 1:30.

[BREAK]

Barry Flamm: Take your chairs. 

Unknown Male: Want some water, Barry?

Barry Flamm: Yeah. I got a glass. Thank you. 

Unknown Male: This is a far cry from [inaudible].

Unknown Female: It sure is. But it is good.

Unknown Male: This is my next group here.

Barry Flamm: Do I still need to make your announcement? 

Unknown Male: You can make it too, or I caught up with everybody so do not worry about it.

Barry Flamm: Okay, I will not worry about it if you caught everybody.

Unknown Male: Hey, Dave. David. [Inaudible]. So one thing we are noticing as people are 

discussing topics in between each other, they are facing away from the mikes. That 

makes it really hard [inaudible] to hear. Their words disappear. [Inaudible] So as you are 

Comment [JMS20]: 04:32:30

Comment [JMS21]: 05:42:27
Meeting Of The National Organic Standards Board

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70

answering questions just try to be a little more [inaudible] somewhat in that direction and 

we will pick it up. Okay.

Barry Flamm: [Inaudible]. We are back in session. John, please continue a Handling 

Subcommittee comments. 

John Foster: Thank you, Barry. 

Barry Flamm: Sorry.

John Foster: Zea just handed me a, an announcement to make to make sure everyone realizes 

there is a reception tonight to join the New Mexico Department of Agriculture’s Organic 

Program for a reception following a day of good work. Today, 5:30 to 7:00 o’clock in the 

courtyard of this here hotel. Is that? You need any more? Good. Good. I am going to 

write myself a note now to make sure to always call on Lisa first. 

Moving back into the agenda, we have two, two more remaining materials then we will 

hopefully have a quick update on, on ancillary and other ingredients, then we will move 

to public comment. First of the remaining two materials are Sunset determinations for 

first one is glucono delta-lactone. Lisa, would you be so kind?

Lisa Brines: Sure. Thanks, John. So, yes, the next Sunset material on the agenda is glucono 

delta-lactone. It was originally petitioned to the National List in March of 2002, reviewed 

by the Board in September of 2002, and added to the National List with an effective date 

of November 4th, 2003. It was previously renewed under the Sunset process in 2008. 

And it is currently listed on the National List with annotation under 205.605 nonagricultural, non-organic substances allowed as ingredients in or on processed products 

labeled as “organic” or “made with organic” specified ingredients or food groups under 

(a) non-synthetics allowed. And the listing and annotation reads: Glucono delta-lactone

production by the oxidation of d-glucose with bromine water is prohibited. Current 

Sunset date is November 3rd, 2013. There is not a new technical report that was 

developed for this round of Sunset. The most recent technical report was developed in 

2002. The NOSB Handling Subcommittee was able to conduct its review according to the 

criteria in OFPA and NOP regulations. And both the petition, the 2002 Technical Report, 

and the NOS, the Handling Subcommittee’s proposal were available to the public on the 

NOP website in advance of the opening of the public comment period for this meeting. In 

addition to the written public comment that was received in advance of this meeting, this 

substance was included within the advanced notice of proposed rulemaking that the NOP

published in June of 2011, which had a 60 day comment period. Thanks.

John Foster: Thank you, Lisa. Joe, I believe you were point on this. Would you be so kind?

Joe Dickson: Thank you, John. Moving back into the world of tofu coagulants, GDL, as we call 

glucono delta-lactone, is also like calcium sulfate used as a coagulant in tofu production. 

It can be produced via two different methods, one of which renders it a synthetic material 

and is not allowed based on the current annotation, that would be the, its production using 

Comment [JMS22]: 05:45:00
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71

oxidation by bromine water. The other, only other method of GDL production is the 

oxidation of gluconic acid with microorganisms or enzymes derived from 

microorganisms, and that does result in what the original NOSB and the, the TAP review

determined to be a non-synthetic form of GDL. That is the form that is currently allowed 

under the listing on 605(a), which reads: glucono delta-lactone production by the 

oxidation of d-glucose with bromine water is prohibited. We received a number of public 

comments on this material. Three commenters, the Soy Foods Association of North 

America, QAI, and Wolf and DiMatteo, supported the relisting of this material. Beyond 

Pesticides also supported the relisting of this material but proposed a restrictive 

annotation that, rather than prohibiting the bromine water method, would positively 

require use of the other enzymatic method, and additionally read, and I will here, I will 

just read their proposed annotation: for use only as a coagulant in bean curd, tofu and 

similar products when produced by oxidation of the d-glucose by non-genetically 

modified, non-pathenogenic, or non-pathogenic and non-toxicogenic microorganisms or 

by enzymes derived from these organisms; no volatile synthetic solvents may be used in 

the crystallization process. Those were the only public comments we received on that 

Sunset recommendation. There any questions or discussion from the Board? Alright. 

John.

John Foster: Alright then. Last of the materials for today are, is cellulose, also a Sunset 

determination. Lisa? 

Lisa Brines: Thanks, John. Yeah, the National List addition for glucose was a result of a petition 

that was submitted in December of 2000. Cellulose was added to the National List 

effective November 4th, 2003 and renewed under the Sunset process in 2008. It is

included in section 205.605 of the National List as a non-ag-, non-agricultural, nonorganic substance allowed as an ingredient in or on processed products labeled as 

“organic” or “made with organic” specified ingredients or food groups. It appears under 

(b) synthetics allowed and is listed with the following annotation: cellulose for use in 

regenerative casings as an anti-caking agent, then in parentheses, non-chlorine bleached,

and filter aid. The current Sunset date is November 3rd, 2013. There was not a new 

technical report that was commissioned for this Sunset review, but there is a, a Technical 

Advisory Panel report available from 2001. The Handling Subcommittee was able to 

review the substance according to the criteria under OFPA and the NOP regulations. And 

the commit, the Subcommittee’s proposal, the 2001 Technical Report, and the original 

petition had been posted on the NOP website and were available to the public in advance 

of the opening of the public comment period for this meeting. In addition to the public 

comment received for this meeting notice, the substance was also included within the

advanced notice of proposed rulemaking published in June of last year with a 60 day 

comment period. Thanks.

John Foster: Thank you, Lisa. And Joe, you lucky devil, I think this was your, your material also.

Joe Dickson: Why, yes it was. So, cellulose, as Lisa just said, is listed on 205.605(b) synthetics 

allowed with the listing: cellulose for use in regenerative casings as an anti-caking agent,

non-chlorine bleached, and a filtering aid. Five commenters, Smuckers, QAI, 
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May 24, 2012

72

International Flavor Additives Council, White Wave Foods, and Wolf and DiMatteo, 

supported the relisting of this material, noting that there are no alternatives in several 

different applications. I in fact noted that, while the production of non-synthetic cellulose 

is theoretically possible, there are no commercially available products on the market at 

this time. Two commenters, and this got a little confusing, so Beyond Pesticides and 

Cornucopia both expressed very significant concerns about the use of microcrystalline 

cellulose, which is a highly processed form of cellulose that it is our understanding is not 

allowed under the current listing. It is also OMRI’s position that microcrystalline 

cellulose is not allowed under the current listing and had some conversations with the 

Program about that. And I am wondering if Emily or Lisa, could you just give us a quick 

overview of your thinking on that question? 

Emily Brown-Rosen: Okay. Sure on, cellulose was originally reviewed in 2001 by the NOSB

and at that time, there, there was a TAP review, actually the same TAP review you, you 

are using this time and which went into detail about three different forms of cellulose and 

the three forms that were described were powdered cellulose, microcrystalline cellulose 

and cellulose used in regenerative casings. The TAP reviewers that were polled in that 

TAP, in the TAP review, none of them were in favor of the microcrystalline form and the 

NOSB discussed, it is in the transcripts, that there was no need for the microcrystalline 

form in inorganic production. There was some debate, but for whatever reason it did not 

specifically annotate cellulose as the powdered form but that was the form that they were, 

they discussed and they felt that the annotation of for only anti-caking age, agents or 

filtering agent would limit that, that would not allow. Microcrystalline is not used for that 

purpose generally, or was not at the time, so they did not feel a need to specify at that 

time. 

Joe Dickson: Great. Thank you. Yeah, so given that we think it is extremely unlikely that 

certifiers are allowing microcrystalline cellulose for that use but we will discuss the 

possibility of adding a clarifying annotation to, to double-check and ensure that that is the 

case. And that is really the summary of comments on that issue. The only, you know,

complicated one was the sort of question of microcrystalline and whether it is, it is out 

there. Any questions or discussion? Jay.

Jay Feldman: Thanks. Just on the alternative side, you know we heard from a, the rice producer, 

the ribus product. Is, is there, does that have a similar function? Or do you know if there 

is an alternative that is possible to use as an anti-caking agent? 

Joe Dickson: My understanding from the commenters is that there, there are applications where 

this is the only functional ingredient. 

Jay Feldman: Yeah. Thanks.

John Foster: More questions? Alright. Ah, let us see. So could we, well I was going to have Zea 

to do a quick little description. Is she there and I just cannot see her? Well. Well, this is a 

predicament. 
Meeting Of The National Organic Standards Board

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73

Unknown Male: Here she is.

John Foster: Right on cue, she is entering the, the room. No pressure, no pressure. Zea, we just 

wrapped up discussion on the cellulose and I was hoping you might give us the update on 

ancillary and/or other ingredients. Sorry to catch you off guard. 

Zea Sonnabend: Okay. We realize that some people may be impatient because they were hoping 

to see a proposal already on the agenda for this meeting after it came out right before the 

last meeting. However, because there were many new Board members, a big workload 

and a complicated subject that we had to work with, we could not complete work on a 

proposal at this time and so we are putting it on the work plan for the next meeting. We 

have, I have decided to enlist the support of the Materials Working Group who has 

historically helped on issues of classification of materials. This Ad Hoc group is open to 

anybody who would like to join it. And we will be developing a proposal to help me 

inform my NOSB colleagues as we work on it in the Committee and we will have a 

proposal for the next meeting. 

Oh, I should add, if anyone is, is interested in joining the Materials Working Group, you 

can talk to Kim Dietz in the back. Kim, wave. Okay, thank you. 

John Foster: Thank you, Zea. 

Jay Feldman: John, can I ask a question now?

John Foster: Sure, Jay.

Jay Feldman: Can you tell me, historically, what collaboration goes on between a working group

and, the Materials Working Group and say the Committee that has jurisdiction over that 

issue? And, and how does that, how do you interface with, with the Board Committee? 

Zea Sonnabend: In the past iteration of the group, there was at least one NOSB member and 

maybe two or three on the calls. And they hashed through the details, you know, of the 

very complicated subjects of what could hap, how do you make a materials decision, 

what are classification. And we, there tries to be a, a pretty broad base between, you 

know, certifiers, OMRI representatives, industry people, trade groups and public interest

sector, who wish to join. But we are real wonky in talking about materials. And so then 

during the public comment periods at NOSB meetings, someone reports on the work of 

the group. In the past has been showing the decision tree for classification of materials, or

sometimes it has been not just public comment but a scheduled presentation within the 

meeting. And then the NOSB Committee takes that under advisement and brings it 

forward like any other NOSB proposal. It is toe...

Jay Feldman: So is the process to bring that to the material of jurisdiction and then to the Board,

or to the Board and then the Committee?
Meeting Of The National Organic Standards Board

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74

Zea Sonnabend: No, the commit. The Committee will work with the Materials Working Group. 

John and I will be, are on the Committee and I am the point person. So I will bring 

forward the Committee's work and we may call on them for a presentation at the next 

meeting or it may be public comment. And we will develop a recommendation from their 

work. 

Jay Feldman: Okay but, but I am just trying to get the process down here. So that would have to 

go to, that would have to be on the work plan somewhere. 

Zea Sonnabend: It is on the work plan.

Jay Feldman: Okay, of the Materials Committee? Okay.

Zea Sonnabend: No, of the Handling Committee. 

Jay Feldman: Of the Handling Committee.

Zea Sonnabend: It was assigned to the Handling Committee. Mmm-hmm.

Jay Feldman: Okay. Okay. Thanks.

Mile McEvoy: Yeah, we need to think this through in terms of how that works with the 

Subcommittees and the public process and the FACA. Because you, you are basically 

forming a group, a voluntary group. So we, we need to talk about this process and how 

that works and aligns with the, the requirements under FACA. 

Zea Sonnabend: Is it any different than me asking for advice from anyone at any point in time? 

Miles McEvoy: Well, you are forming...

Zea Sonnabend: Including my job? 

Miles McEvoy: You are forming a, it sounds like you are forming a group. Now we have some 

informal groups that have formed, as the Methionine Task Force and the, the Fire Blight 

Task Force, and there are independent groups that have assembled people together 

independently and are providing information on given topics. So now you are sort of 

trying to form a subcommittee of the Handling Committee.

Zea Sonnabend: No. It is just a group of, that already existed and we are resurrecting it, of 

colleagues to give me input in developing a proposal. 

Miles McEvoy: Okay.

Zea Sonnabend: It has no standing at all within the NOSB or NOP scheme of things. They are 

just helping me bring a proposal to the table. 

Comment [JMS23]: 06:00:00
Meeting Of The National Organic Standards Board

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75

Unknown Male: [Inaudible]

Miles McEvoy: So how does that relate to the NOSB? 

Zea Sonnabend: What?

Miles McEvoy: How does that relay, how does that interface [inaudible]?

Zea Sonnabend: I will bring a proposal to the Material, to the Handling Committee and we will 

put it through the regular process. You know, the how a, how a Committee develops a 

proposal. 

Miles McEvoy: I guess the question is how do you make this an open opportunity for folks that 

want to be involved to be involved?

Zea Sonnabend: It is open. Anyone can talk to Kim.

Miles McEvoy: Well, it is open in an announcement that you are making here at this meeting. 

There is a lot of people who are not on, at this meeting that might not hear you make that 

announcement. Who do they contact? So we have got to figure this out in terms of a 

procedural way so we make it open and transparent to everyone that has an interest in this 

particular topic. Because otherwise it is just that your, you are, you would be creating a 

select group of people that would, would be able to provide input. 

Zea Sonnabend: There was no problem with Katrina doing it before. Has that changed? 

Miles McEvoy: Yeah. It, the, the, it may have. Yeah. 

Zea Sonnabend: Okay, well then you have to explain to me, you know, I, I thought I could ask 

anyone I wanted for advice in doing my job as an NOSB member.

Miles McEvoy: Yes, you can do that.

Zea Sonnabend: Okay.

Miles McEvoy: But what you are talking about is forming a group that is, if you are forming a 

group that is associated with the NOSB, then it has got to got, go through some kind of 

[inaudible]. 

Zea Sonnabend: The group is not associated with the NOSB. 

Miles McEvoy: Okay. So then it is not part of this process then. You are just [inaudible].

Zea Sonnabend: Okay. Just forget I just said all that, and I will determine appropriate advice and

... 
Meeting Of The National Organic Standards Board

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76

Crowd: [Laughs]

Miles McEvoy: But how about we work together to, to make sure that it is an open process that 

people can participate in and provide information to as they collaborate on this.

Zea Sonnabend: Okay. It is an open process, and this is very weirdly confusing to me, so we will 

have to talk off-line. 

Miles McEvoy: Sounds good. 

John Foster: I am, I am certain we can figure out how to make it work the way it needs to work. 

How about that? How is that? 

Miles McEvoy: Yahoo. 

John Foster: So, at this point, I would like to move into taking up public comment. I apologize, 

we are about an hour behind. So I am going to, I am going to guess that there is going to 

be a couple of subjects in here that are going to bring up a little more discussion, so in 

light of that, I will, I will, you know, try and divvy up the, the question time, postcomment, you know appropriately. I will do my best. But if there is any chance we can 

get back on, on track, I, I will try to do that. So with that, I have, I have the most recent,

hot-off-the-presses list of public comment. I understand it is changing periodically but, I 

have got, I got one that is ten minutes old. 

So, first up will be Luis Mon-, Mon-jay, Mon-gay, hard gee, soft gee. And then up on 

deck would be Maria Herrero.

Nice.

Luis Monge: Excuse me. It is okay. Hi. Wow. Good afternoon. My name is Luis Monge. A, I am 

the manager of Dole Fresh Fruit International, Organic Program. We grow and source 

organic bananas and pineapples in five different countries in Latin America since 1996. 

The organic program supplies more than 90,000 tons of fresh organic bananas to the US

market every year. Our organic bananas are currently grown in Ecuador, Colombia, and 

Peru by more than 2000 micro, small, medium and large farmers. And I came here today 

to speak on their behalf. 

Organic banana growers from South America fully support the Handling Committee 

recommendation to include the use of gibberellic acid on 205.605 for postharvest use of 

bananas. Gibberellic acid represents a very helpful tool for organic banana growers in 

order to reduce the volume of rejected fruit, especially during rainy season. I do not think, 

I think I do not need to tell you how difficult it is, it is to grow organic bananas, 

especially with extreme weather conditions the planet has been facing during the last 

years. And I need to say that I have changed the approach of this comment several times 

during the meeting. But at the end I realize that the more, the most important argument I 

can present to you at this time is the people. Yes, the people we handed delicious bananas 
Meeting Of The National Organic Standards Board

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77

some of you, hopefully most of you have tasted in your life, and especially during the last 

two days. Organic, organic banana growers of Peru, Colombia, Ecuador are fighting 

against many different factors, including the most aggressive variation of Mycosphaerella 

fijiensis, which is the, the scientific name for Black Sigatoka. And the only way that they 

have to survive as organic growers is by maintaining their ability to sell the fruit into the 

organic market. Years of research have shown that the use of gibberellic acid postharvest 

on bananas allows farms to ship their fruit to the market with a much lower risk of early 

ripening and subsequent rejection of the fruit and the huge economical losses. On behalf 

of the more of 2000 organic banana farmers, their families, and their workers, I ask you 

to approve the petition to include gibberellic acid on 205.605. Thank you. That is it. 

And then the footnotes, okay? Regarding the comment from Zea on the public comments,

Dole organic banana growers have sent letters to the Handling Committee on this regards 

on March 2011, August 2011 to the NOP, and September 2011. Regarding the comment 

from the six million pounds of bananas produced in Mexico, I have to say is that this is 

equivalent to three containers a week and according to my numbers, it would be no 

higher than the 2 percent of the US market demand. Producers in Mexico are in a 

privileged situation since their transportation time to the US market is just 30 hours by 

truck compared to the 15 to 21 days by parcel that the organic bananas produced in South 

America require to arrive the US market. And I will be more than glad if you ask me the 

question on the Sigatoka thing. I can answer that. 

John Foster: Thank you, Luis. Any questions? Colehour.

Colehour Bondera: Yes, thank you. Thank you, Luis. I guess I am going to ask my question 

pretty generally. But I, I understand the difference that you were mentioning related to 

transportation in terms of where the bananas are coming from but my question is, what 

were organic banana producers in these countries, if we are talking about Ecuador and

Peru, or whatever specific countries, doing in the past in terms of controlling for Black 

Sigatoka in their bananas? 

Luis Monge: Okay. First of all, we have not faced the extreme weather conditions that we are 

facing today. It has no precedent. For example, in La Guajira, Colombia, northern 

Colombia, in 2005 we opened a, a 450-hectares organic banana farm. At that time, with 

the recollection of the statistics and rainfall, we knew it for sure that that region receive 

less than 100 inches of rain a year. 2011, the same region receive 1000 inches of rain. 

That means that there is a big change in weather conditions. That, that is number one. But 

addressing directly your question, what have we done in the past? And this is the first 

claim that I received in my website, doleorganic.com. If you want to check it out, you 

can. A, the consumers are just yelling at me because it is not a, it is not fair, it is not on 

the same concept of organic that we grab organic bananas with plastic. We have done that 

because it is the only available alternative and it is very expensive by the way. That we 

can simulate a anaerobic condition to the crown of the fruit so we can in a, in a very 

ineffective, but it is only resource we have, to delay the early ripenings of the fruit. Just 

as a, as a comment I, I feel that this is important. Gibberellic acid is not intended to 

control Black Sigatoka. In fact it is very ineffective by controlling Black Sigatoka. What 
Meeting Of The National Organic Standards Board

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78

we really need is to delay the natural message that, that the plant sends to the fruit, that it 

is something like, hey, I am dying, you have to ripe right away, we have to preserve the 

species, something like that. But we want to delay that message to the fruit so the fruit 

will survive that transportation time. 

John Foster: Thank you, Luis. Another question? Zea.

Zea Sonnabend: The, the question that I do not think we have had answered, that I keep coming 

back to is there seem to be a lot of bananas in the store now. There does not seem to be a 

shortage of bananas and this is not approved yet. So what would you say about that point 

of view? 

Luis Monge: Okay. I, I would have to disagree with that comment. I mean I have to go to four 

different supermarkets in Albuquerque to find the, the bananas that I brought to the 

meeting. And it is something that is just happening. And it is not only the US market that 

is growing, because it is growing, but we also have, I mean, the US market has the 

competition from Europe and the increasing demand in Asia. So this is, this is about to 

happen. What, why, what has or what is the reason why there is not a, a, or what is the 

reason why the markets still have enough bananas here is because we have been growing 

more land and we have been moving from the regions where the Sigatoka is a, is a major 

disease to a semi-deserted regions in, in the tropics. But that portion of land is limited. 

We cannot keep moving to an, another place. And the problem is not about the importers 

and the exporters because if I see this situation from the importers point of view or, or the 

exporters, we can change the suppliers. But the point is what happened with the growers? 

The growers have only their land they have. They cannot move their farm to another 

place. They have to live with it. And if they get without resources to face this situation, 

they will move into conventional production once again. 

John Foster: Alright, thank you, Luis. We appreciate it. Carmella.

Carmella Beck: So, Luis, you said that there was 90,000 tons of, of bananas that you export to 

the US, is that correct?

Luis Monge: Yes, yes.

Carmella Beck: And so in pounds, what is that? 

Luis Monge: Well, times 2.2 times 1000. Something like 90 million, something like that. 

John Foster: One hundred and 80 million. 

Luis Monge: Well it is like, I, I put it in, in containers, so you can make the compare with the, 

the value from the commenter, from the volume coming from Mexico. The volume 

coming from Mexico is only three containers a week and the volume that Dole is

supplying the US market is 50 containers a week. 
Meeting Of The National Organic Standards Board

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79

John Foster: Thanks. Jay, did you have something? I saw your hand up?

Jay Feldman: Yeah. We received a statement from Organically Grown Company. Do you know 

them? 

Luis Monge: Yeah.

Jay Feldman: Yeah. And ...

Luis Monge: I read their comment, at least [inaudible].

Jay Feldman: You read their comment. So do you have a comment on their comment? 

Luis Monge: Well, yes. All I can say is that they have a ground approach to the question because 

they, as their, their managers, the people in the fields, if they find a gibberellic acid as a 

useful tool to fight against Sigatoka and there is not why, that is not the question. I mean, 

even I do not use, or I cannot use a gibberellic acid to fight against Sigatoka because 

there is no control. There is no control. And Sigatoka does not affect the fruit after 

harvest. The problem is, and this is, this is something that needs to be explained is a

banana plant produces one leaf a week. Alright, right? There is one new leaf on the plant 

every week. Once the fruit appears, the, a, the leaves, the production of leaf stops and all 

the energy of the plant goes to the development of the fruit. It means that if at the time of, 

of the appear of the fruit, you have eight, eleven or three leaves, that is all you have to 

develop and grow that fruit. If there are not enough leaves on the plant, the fruit is going 

to receive the natural message from the plant to the fruit saying, you have to ripe because 

we have to preserve the species. I mean, I am, I am dying. I, I do not have enough 

resources to make you grow. You have to ripe right away. And this is, this, this situation 

can be caused because of drought, floods, winds, but the, the main reason is the attack of 

fungus and the main fungus that attack the, the banana plantations in Latin America is 

Black Sigatoka. So answering your question, they did not ask the right question to the 

farmers. 

John Foster: Thanks, Luis. Tracy, and then we are going to have to wrap this up. 

Tracy Favre: Hi, Luis. 

Luis Monge: Hi.

Tracy Favre: I, I am a little confused. I hear that the, the gibb is not used for control of the 

disease. It is to delay ripening of the fruit for transport. Is that correct?

Luis Monge: Well, while the plant is attached to the plant, the fruit is receiving natural 

gibberellic acid from the plant so the fruit stays green. Right? Once you take the, the fruit 

out of the plant, that supply is no longer there. It is not a problem if, if there is enough 

leaves to make that fruit develop and grow, but when you do not have enough leaves, that 

fruit is in a high risk to early ripening. 

Comment [JMS24]: 06:15:00
Meeting Of The National Organic Standards Board

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80

Tracy Favre: Okay. So that, that kind of maybe answers the second part of my question. Because 

you had made a reference to the fact that some, some growers could not move to new 

land but that purchasers could go to other growers and other land. And so do I understand 

you to say that the existing growers that are having problems with the disease would, 

would benefit from application of the gibb, gibberellic acid to be able to continue to stay 

and produce there, but it is not specifically because of the control of the disease. It is 

because that they cannot afford to move to another location and start another farm where 

they would be away from the disease. Am I making myself clear? 

Luis Monge: Yes, yes. And, and I think your appreciation is correct. 

Tracy Favre: Okay.

Luis Monge: Thank you.

Tracy Favre: Thank you.

John Foster: Thank you very much, Luis. 

Luis Monge: Welcome.

John Foster: Right up here now we have Maria Herrero and then Lynn Coody is up after this. 

Maria Herrero: Hi. I have, yes, a presentation so I am not a very good public speaker unless I 

have something to follow. So the next, okay, thank you. Okay, first of all, USDA has 

come out indicating that for organic practices, one of the major problems is postharvest 

decay to maintain food safety and also competitiveness. I also want to mention that 

gibberellic acid, while not GRAS because it is not specifically added to food, is found in

food because it is a natural component of vegetation. The FDA has reviewed it, because 

there were some people who were concerned about the toxicology of it, and it is used 

actually be for malting of beer because the barley grains actually all contain gibberellic 

acid. For malting, you need to germinate that grain, but different grains have different 

amounts of gibberellic acid in them. So there is a natural indication already from FDA

that they, they are okay to be used in this compound. As has been indicated, bananas are 

usually harvest mature green stage but they are green and they stay green because the 

gibberellic acid maintains the chlorophyll content that they have. GA3, as has been 

indicated, has nothing to do with controlling Black Sigatoka. It is just the way for farmers 

to be able to get to the market. There were indications as to what alternate methods are 

available and, as been indicated, those are polyethylene bags, controlled atmospheres in 

terms of changing the atmosphere that they are shipped in from a oxy-, from a CO2

component to an oxygen is also available. Those are extremely expensive and really not 

used very much. Those methods are much more expensive and less sustainable and less 

effective than the gibberellic acid. This is the picture of actually how the gibberellic acid

is done and it, you can see they are simply brushing it to the crown of the banana. And 

the substance is not used as the preservative, although that has already been indicated. It 
Meeting Of The National Organic Standards Board

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81

is simply to maintain the natural healthy activity of the banana. The GA3 is metabolized 

within the banana and then the fruit ripens normally. And then for citrus, basically what I 

want to indicate is, and I did not explain myself very well in the comments that we sent 

out, citrus is treated postharvest with all kinds of fungicides. Organic citrus does not have 

that ability. The only thing they have are hot water treatments. What happens, they are 

trying to reduce the number of spores of fungi on them. Stop there.

John Foster: Thank you. Are there questions? Calvin?

Calvin Walker: Could you explain a little bit more on your slide dealing with alternative methods 

instead of the GA? 

Marie Herrero: The alternative methods that are available right now, if you wrap the bananas in

plastic so you try and create an, an atmosphere, sort of reducing the atmosphere so they 

are not available com-, they are not exposed to any air. That reduces the amount of 

harvesting. Not very effectively, but it does work to some degree. 

John Foster: Calvin. Follow-up comment.

Calvin Walker: Could you, oh. Could you give me a percentage of level of effectiveness for 

some of these alternative methods? 

Marie Herrero: That would have to come more from my colleague, Luis, than from myself. 

Zea Sonnabend: Will you call on me?

John Foster: I [sigh], I am not really, I am not comfortable. We are taking a lot of time on these. 

Is there a way we can follow up with that at a, at a break perhaps? Luis, will you be 

around during, for the rest of the day?

Luis Monge: Yes.

John Foster: Maybe we could follow that, that follow-up question. Could we do at a break, is that 

all right, Calvin? To follow-up on that at a break, is that okay? 

Calvin Walker: That would be good.

John Foster: Okay, thanks. Then, Zea, then we should wrap up. 

Zea Sonnabend: Could you comment on waxes as an alternative because we do have some 

organically approved waxes for citrus, for the use on citrus. 

Marie Herrero: That is correct but those waxes are put on warm, the same way that the hot water 

treatments are and what happens is it causes pitting in the citrus and that pitting actually 

permits the fungi to enter in. The gibberellic acid again has no control on the fungi 
Meeting Of The National Organic Standards Board

May 24, 2012

82

themselves, it simply maintains the health of the peel so that the pitting does not occur 

and fungi do not enter.

Zea Sonnabend: Thank you.

John Foster: Thank you. Lynn Coody is next and then on deck is Rob M., no Rob Moore I 

believe. 

Lynn Coody: Thanks, I am afraid I will fall off it. Okay. Now for the other side of the issue. My 

name is Lynn Coody and I am commenting on behalf of the National Organic Coalition, a

national alliance of org-, organizations representing farmers, environmentalists, industry 

members and consumers concerned about the integrity of the national organic standards. 

As an overview, I would like to point out that the NOP regulations do not clearly 

addressed postharvest handling issues creating a kind of no-man's land for the regulation 

of activities that occur between farming and processing or packing. NOC asserts in 

general that control of postharvest diseases on organic produce must begin in the field. 

The NOP regulation lays out a stepwise approach for disease control in 205.206 which 

specifically requires the use of soil and crop nutrient practices, sanitation measures to 

remove disease divec-, vectors, and management practices which suppress the spread of 

disease organisms. Careful attention to such practices can reduce or even eliminate the 

need for the use of materials in postharvest handling. According to our research, this 

principle is relevant to the petition for gibberellic acid. The reason that we, we got started 

on this topic was the note from the Handling Committee asking the question about the 

possibilities to reduce disease incidence of Black Sigatoka. That was a specific request 

from the Handling Committee and that is what we responded to. So NOC urges the 

NOSB to wholly reject the petition for a listing gibberellic acid for postharvest use 

because it fails the evaluation criteria 2.10 that the material should be necessary to 

production. In general, we agree that the commit, with the Committee's findings that the 

gibb should not be allowed for postharvest use on citrus based on the inf-, information in 

the technical evaluation report that the material reduces the nutritional content of citrus 

fruit. We agree with the Committee that the petition does not make an adequate case for 

use on pineapples. However, NOC does not agree with the recommendation that supports 

the use of gibberellic acid for postharvest handling of bananas. As Zea mentioned, we are 

basing our opinion on this on information detailed in the comments of a NOC member,

Organically Grown Co-, Company, the largest distributor of organic fruits and vegetables 

in the Pacific Northwest. Zea gave some background on the poll that OGC did. They 

learned that farmers currently employ cultural practices in order to control diseases that 

affect bananas during shipment. These agricultural management practices coupled with 

good sanitation dur-, during at harvest and practice were sufficient to control postharvest 

diseases including Black Sigatoka, which is specifically mentioned in the technical 

report. So that as far as I can get and so I will stop there.

John Foster: Thank you, Lynn. 

Lynn Coody: Thanks.
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83

John Foster: Is there a question? Colehour.

Colehour Bondera: Yes. Thank you. Thank you, Lynn, for, for what you were able to present and 

I would appreciate it if you would at least in brief talk about some of the farm 

management or farm system approaches that you just stopped on because I would be 

curious as to understanding those alternatives a little bit better. Thank you.

Lynn Coody: Thanks, I would be happy to do that. The reason that I, I feel that there is at least 

some relevance of Black Sigatoka to the need for gibberellic acid is as one of the 

previous commenters noted, when the leaves fall off the, a plant, it does not have enough 

energy really to, to keep the, the fruits from ripening. Well, as he explained, the, the

gibberellic acid is a, is being supplied to the plant, to the fruits and then when, when the

leaves fall off, the plant is ready to just give up on it and the, and that creates the, the 

difficulties in shipping. But why are the leaves falling off? That is from fungal spores. So 

that, so we go back to trying, if you can control Black Sigatoka, you may have a better 

chance at having healthier fruit come off the plants. So on behalf of NOC, after we got 

the information from a NOC member Organically Grown Company, I did some research 

in plant pathology literature that reinforced the growers’ experiences that, that were 

reported to OGC. So the, the research that I did found that there were other things that 

growers could do and do indeed do, especially growers who are more, I do not know, you 

might say subsistence farmers or smaller growers. They use, they use the following 

things were reported in plant pathology literature as things that might, might help as a 

systemic in a, like in a farm plan situation to, to create a good enough amount of control. 

So field sanitation, good drainage, increased plant spacing, inter-planting with nonsusceptible crops, planting in partial shade, and also back up with two materials that are 

already listed on the National List, Bordeaux Mix and Horticultural Oils, are currently 

used to help control Black Sigatoka as a system, systematic approach, not a one-on thing, 

everything used together in order to create a farm plan that is viable for an organic 

grower. And in addition there are breeding, breeding programs in multiple countries that 

are focusing on ver-, banana varieties that are resistant to Black Sigatoka. So thanks. 

John Foster: Thanks, Lynn. Okay, we got, we need to, we can, we can go if it is important, let us 

do it. Alright, we are, I am going to try and focus on newer voices if that is alright. So, 

Harold, go for it and then we are going to have to wrap it up. 

Harold Austin: Okay. In the scope of the, of the growers that you are getting the information 

from, the climatic conditions that Luis was talking about versus the growers, as far as the 

annual rainfall, do, do you have any of that, that comparison?

Lynn Coody: No, I am sorry I do not. The, the growers that they, that they polled were mostly in 

Mexico and Peru and some in Equador I believe. But that is, that was the, the range of 

growers, that they, they, these are just the growers who supply them, that is all they have 

information from. 

Harold Austin: Because I think, I think, you know, when we are, when we are looking at the 

disease vectors and stuff, I think, you know ...

Comment [JMS25]: 06:30:00
Meeting Of The National Organic Standards Board

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84

Lynn Coody: Oh, yeah.

Harold Austin: ... the amount, the amount of humidity and moisture ...

Lynn Coody: Absolutely.

Harold Austin: ... is still going to have a significant impact. 

Lynn Coody: Yeah, no, no doubt about it, I agree with you completely. 

Harold Austin: Thank you, Lynn.

Lynn Coody: Yeah. Okay.

John Foster: Thank you very much, Lynn. 

Lynn Coody: Thanks, guys.

John Foster: Thank you. Next up we have Rob Moore and then Cheryl Van Dyne is on deck.

Rob Moore: Hello, my name is Rob Moore and I live here in Albuquerque, New Mexico. I am 

here as a consumer and as a retailer through my work with La Montanita Co-op to urge 

you to protect those of us who choose to eat organic foods. I am here to ask you to 

remove carrageenan from organic foods. Carrageenan can be classified as low molecular 

weight degraded carrageenan, or high molecular weight, or un-degraded carrageenan. 

Processors tend to portray the difference between degraded and un-degraded carrageenan 

as a simple black-and-white distinction. They claim that food grade carrageenan sold to 

processors falls entirely in the un-degraded category and is therefore safe. However, 

studies including industry funded studies have shown that food grade carrageenan is 

linked to colon inflammation and colon cancer in animals. Humph. Studies have reported 

that high molecular weight carrageenan can degrade in the gastro-intestinal tract to low 

molecular weight carrageenan. In 1975, a study with Rhesus monkeys found adverse 

effects in the intestinal tract when the animals were given low levels of un-degraded 

carrageenan in their drinking water. In 1978, a study published in Cancer Research found 

that rats fed a diet containing un-degraded carrageenan had higher rates of cancer than 

rats fed a controlled diet without carrageenan at all. The authors concluded, quote, the undegraded carrageenan in the diet had an enhancing effect in colorectal carcinogenesis in 

rats. In 1980 and 81, leading carrageenan researchers Marcus and Watt published two 

letters in The Lancet titled “Danger of carrageenan in foods” and “Potential hazards of 

carrageenan” respectively pointing out health concerns with the consumption of 

carrageenan including un-degraded carrageenan. They noted that they harmful effects of 

un-degraded carrageenan in animals, quote, are almost certainly associated with its

degradation during passage through the gastrointestinal tract, unquote. In 1983, the 

World Health Organization classified degraded carrageenan as a group to be possibly 

carcinogenic in humans. In March 2003, the European Commission Scientific Committee 
Meeting Of The National Organic Standards Board

May 24, 2012

85

on Food reviewed safety data on carrageenan. The Committee suggested that the amount 

of degraded carrageenan should be kept to levels below 5%. Your decision should be 

based on the law as a Committee and the law states that ingredients with adverse human 

health effects should not be in organic foods. Please reject the relisting of carrageenan. It 

is clear from the preponderance of scientific studies conducted using food grade 

carrageenan that there are reasonable questions about its safety in any food, much less 

organic foods. As an organic consumer and a father, I want you to rely on the organic, I 

want to reply on the organic label as an assurance that there are no potentially dangerous 

ingredients in our food. If I have to choose between a chocolate milk that I have to shake 

before serving it to my children or chocolate milk that I do not have to shake but contains 

an ingredient that is a potential carcinogen, I do not think I have to tell you which one I 

will choose. If I do, it would be the one without. Thank you. 

John Foster: Thank you. Do you have a question? Thank you, sir. Next, we have Cheryl Van 

Dyne and Troy Aykan on deck. 

Cheryl Van Dyne: Thank you for the opportunity to speak. My name is Cheryl Van Dyne. I am 

the Director for Regulatory Affairs for CP Kelco. To address the Sunset: CP Kelco is a 

carrageenan producer and a member of Marinalg, the seaweed producers industry group, 

and we respectfully request that the NOSB accept the recommendations of the Material 

Handling Committee to relist carrageenan with no annotations. My objective is to provide 

information to the Board if there are questions for which we as CP Kelco carrageenan 

producers would have science or safety knowledge that you would need to, regarding 

carrageenan. In regard to safety of carrageenan, carrageenan safety has been reviewed by 

leading world health organizations and deemed safe as a food additive. These include 

JECFA, the Joint Evaluation Committee for Food Additives of the World Health 

Organization, the European Union, and the US FDA, and many other countries globally. 

These safety reviews were based on validated safety and toxicology studies. The food 

additive carrageenan is not polygeenan and carrageenan is a soluble fiber. The 

uniqueness or essential functionality of carrageenan, when carrageenan is used, it can be 

used alone or it can be used with other materials to impart properties to organic consumer 

foods, beverages and other uses that are unique and essential to the producers’ product. 

For organic status, carrageenan is approved in global organic production standards and 

regulation without concern. In regard to synthetic, it is requested that any evaluation of 

synthetic be done after the NOSB has well established the criteria for synthetic and nonsynthetic and at that time it is recommended that all materials be reviewed at the same 

time and that we request that the Sunset review of carrageenan or any other material not 

be used for the evaluation of synthetic or non-synthetic. Thank you. 

John Foster: Thank you very much. Do we have a question? I see Harold and Mac.

Harold Austin: Thank you.

Cheryl Van Dyne: Okay.
Meeting Of The National Organic Standards Board

May 24, 2012

86

Harold Austin: Oh, no, I have got a question for you. Could you explain to us, during the 

harvesting of the material, you know, there is, there is some environmental concerns, you 

know, that there may be some negative effects on, on biodiversity the, on, on the

environmental impact. Could you explain to us that process and what safety pol-, 

procedures you have in place to make sure that that does not happen if there is such a, if 

you do have such a policy in place? 

Cheryl Van Dyne: The, the farming of carrageenan, it is farming and I am going to let Bill from 

FMC speak to that. He has prepared some slides on the farming for you. And I think it 

would be helpful. But as far as environmental impact, these are family owned farms. It is 

well documented that there is no environmental impact in the way of carrageenan is 

farmed and I will let him speak to that. He is, he is well prepared to speak to that. Any 

other questions? 

John Foster: Thank you. I had Mac and then Jean if we have got time. We are going to keep it 

quick. Oh, Jean is going to hold off, so Mac.

Mac Stone: If, if someone were averse to carrageenan, does it always show up on the label of the 

product? 

Cheryl Van Dyne: Depending upon the food regulations for labeling, I would assume that it 

would. Food additives are required to be labeled in most regulations so if you, and it 

depends on the order of precedence and sometimes they are put together but yes, 

carrageenan would show up as carrageenan as a rule. You would have to check with each 

individual country regulations. But in the US, for certain. 

John Foster: Fine. Thank you very much for your time. Next up we have Troy Aykan and Harris 

Bixler on deck.

Troy Aykan: Can I have the remote control please? Fine. Which one? This? Okay. Thank you. 

Sorry. [Laugh] I was too close. My name is Troy Aykan. I am a lawyer with a back, 

background in food science and nutrition. I work for The Hain Celestial Group. I also 

teach part-time food laws and regulations at two different universities in Southern 

California. We support the Handling Committee’s recommendation to allow both choline 

and inositol in National List for use in infant formula labeled “organic” or “made with 

organic”. Choline and inositol are added to infant formula because they are essential for 

the proper growth and development of infants. These two nutrients are also classified as 

GRAS, which means generally recognized as safe, and permitted by the FDA for addition 

to both milk and non-milk infant formulas. Furthermore, FDA mandates choline and 

inositol to be added to non-milk-based infant formulas. But they are, they have always 

been added to milk-based formulas because cows’ milk do not contain as much inositol 

and choline and, and when they do, they are, the values vary. So manufacturers cannot 

get a stable nutrition profile without adding it. When it comes to choline and products

other than infant formula, the Handling Committee recommended that it, choline would 

be allowed in only “made with organic” category. However, toddlers and young children 

are not infants, but they are vulnerable to inadequate intakes of nutrients because their 
Meeting Of The National Organic Standards Board

May 24, 2012

87

brain and other organ systems are still developing. In national health and nutrition 

examination survey found that all segments of the US population have inadequate intakes 

of chol-, choline. Foods fortified with choline will help ensure that these young children 

and adults receive proper nutrition that they need. According to an OTA survey, 78

percent of the organic food consumers stated that they would prefer buying fortified 

organic foods was either very important or somewhat important. Consumers should be 

able to purchase an organic product with fortification if they choose to do so. We urge the

Board to vote yes to adding choline and inositol to infant formulas. In addition, we urge 

the Board to allow choline to be added to “organic” and “made with organic”. 

Additionally, we strongly support the relisting of cellulose, calcium sulfate and glucono 

delta-lactone as these substances are GRAS and do not pose any risk to the environment. 

Thank you. Any questions? 

John Foster: Thank you. Is there a question? Jay.

Jay Feldman: Thank you. So maybe I, you can help me understand the law since you teach it. 

What better person to ask, right? 

Troy Aykan: Yes.

Jay Feldman: Are there foods, or there are foods, how many are there, that require, are required 

by FDA to be fortified or to, to contain a certain level of essential ingredient? Can you 

give me a couple examples of that? 

Troy Aykan: Yes, sir. The FDA, as, as a general rule, if you look at the spirit of the laws, we do 

not like to mandate people add stuff to foods unless we think that, you know, it is, like,

targeted for certain populations or special dietary use. To make the long story short, that 

FDA decides, decides that certain categories of food should be fortified with given 

things. Examples, fruit juices that, although it is not mandatory, okay, they say you may, 

but you, I am sorry, you said when it is manda-, mandatory. 

Jay Feldman: Mandatory, yeah, required.

Troy Aykan: Yeah, okay. Let me rephrase that because I was talking about prescribed nutrition 

but not necessarily mandatory. When it comes to man-, mandatory nutrition, I could think 

of the infant formula obviously.

Jay Feldman: Yeah.

Troy Aykan: And other than the infant formula, what else would be mandatory by the FDA is 

that, yeah, I cannot think of any examples that very specific fortification [inaudible]. 

Jay Feldman: I am thinking vitamins as well, sort of like milk, vitamin D. 

Troy Aykan: Again, vitamin A and D to milk and margarines, they are, they are codified 

regulations but they are not mandated. You may purchase milk without vitamin A and D. 
Meeting Of The National Organic Standards Board

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88

Jay Feldman: Okay, so now switching to this particular proposal, what category would this be in, 

this, this, you know, choline and inositol, or choline? Would this be in a category of 

mandate [inaudible]? 

Troy Aykan: Mandate.

Jay Feldman: Mandated. In what? In, in soy-based or in milk-based? 

Troy Aykan: Choline it, it, this is a, by I understand enough to regulations, choline and inositol 

must be present in the infant formula, whether it is milk or, or non-milk. At the time the

Infant Formula Act passed in 1990, the legislature or the FDA thought that for non-milkbased formula this must be mandated because they would not be getting any. For the milk 

formula, they did not mandate it, thinking that this would be coming from milk. But in, in

practice, that assumption by the FDA did not seem to have worked out. The 

manufacturers over the course of 32 years determined that the only way, because let me 

back up and tell you this too. The, the choline and inositol must be reported on nutrition 

facts label on an infant formula. Okay? If you are using non-milk, then you have the 

mandatory addition and list it. If you are using milk formula and, and not adding any inf-, 

inositol and choline, then you may be reporting two to three, which is like it should be 

four to seven and it may be falling short of what is deemed as proper in a infant formula 

by the FDA. So to make up the difference, the manufacturers are adding with the FDA's 

permission and approval to match those levels.

Jay Feldman: Thank you. Thanks.

Troy Aykan: You are welcome.

John Foster: Thank you, sir.

Troy Aykan: You are welcome. One more question?

John Foster: Yes, sir.

Troy Aykan: Great. 

John Foster: Got to go quick.

Calvin Walker: What would be an alternative to choline? Choline is a vitamin, right? 

Troy Aykan: Yes, it is.

Calvin Walker: So what would be an alternative to choline? Would breast-feeding resolve that?

Troy Aykan: Oh, how do we get choline in our diet? Yah, the breast milk is, you would get it in 

breast milk obviously if you are breast-feeding. And infant formulas, as we always say, 

Comment [JMS26]: 06:45:00
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even, even though on our packaging, that the best way to feed a baby is by breastfeeding. But if for one reason or another reason, you are unavail-, available to, or unable 

to do so, we offer you this, to, to you know closest match that we could offer as permitted 

by regulations. 

John Foster: Thanks. We do need to move along. Thank you, sir. 

Troy Aykan: Thank you.

John Foster: Next up Harris Bixler and following him is Beth Unger. 

Harris Bixler: I am Harris Pete Bixler, an MIT graduate in colloid chemistry with a Ph.D. I am

been in the carrageenan industry for 43 years so I hope I speak with some authority. I am 

here as a member or a director of Marinalg International. It represents the producers of 

agar agar and carrageenan. Probably the most useful comments I can make is to fortify 

the health, safety of carrageenan when used in foods. First of all, we start with a premise 

that the major international regulatory agencies have all approved carrageenan for use in 

foods when used at GMP. The, these conclusions by these organizations have been based 

on the study of in recognized animal species and at, at recognized protocols. A lot of the 

information in the literature on carrageenan is based on faulty protocols or in 

inappropriate animal species. And I, I think that the report made to you this morning 

made it clear the distinction between the two. The other thing we are seeing a lot of these 

days are in vitro studies, lab bench studies, if you will, on carrageenan and while those 

studies are very interesting, I think it is going to be a while before we, they can support 

their claims of carrageenan being unsafe as a result of the in vitro studies. There were 

several questions that came up from Committee members earlier and one in particular 

was about the metabolism of carrageenan in the human gut. And care, the human gut 

contains no bacteria that may naturally make carrageenan, carrageenase, the enzyme 

necessary to, to metabolize the carrageenan. And this is, you can demonstrate this 

principle on, on the laboratory bench by showing that the apparent VOD of carrageenan 

is very high, but in fact it is not. And the reason for that is that to generate, there is a long 

lead time needed to generate the per-, the bacteria that can metabolize the, the

carrageenan itself. So that, the, the human gut just does not have the ability to metabolize 

carrageenan. The, there are few experiments in the literature, they are very difficult to 

perform, but clearly show that at least 95% of the carrageenan that goes through the gut 

is, is excreted in the feces or excreted in the urine. And with that, I will thank you. 

John Foster: Thank you very much. Is there a question? Zea.

Zea Sonnabend: Thank you. Could you comment on the anecdotal reports that we receive about 

incidences of colitis from consuming carrageenan?

Harris Bixler: I, I know of no studies that are done under a reputable prota-, protocol and where 

the fault is, usually is the way in which the carrageenan is introduced into the body. For 

instance, in drinking water, the problem there is carrageenan is a great water absorber and 

in many cases the animals are dehydrated as a result of the way in which they are 
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receiving carrageenan. So I know of none that, and I know of none myself and certainly 

the regulatory agencies have not found any in their examination that are reliable and upon 

which you can make conclusions. 

John Foster: Thank you very much. We, a quick follow-up maybe? Alright, we have to keep, 

yep, quick.

Zea Sonnabend: [Inaudible]

John Foster: Yep, I know. I know.

Zea Sonnabend: Could you state your opinion on the amount of degradation of the high 

molecular weight carrageenan that occurs in the handling and extraction of it before it 

gets into a person's body? 

Harris Bixler: Yes. You know, the, the European Commission has placed a limit on the amount 

of degraded or low molecular weight carrageenan that can be in food-grade carrageenan, 

that is less than 5% less than 50,000 molecular weight. The problem is, that is a very 

difficult analytical job, even with today's most modern spectroscopic equipment. The 

amount is so small that the analyst is virtually having to count the, the molecules of 

carrageenan present. What we can say with assurance is that there is probably less than 

5% and definitely less than 10% of that material less than 50,000 molecular weight in 

food-grade carrageenan. 

John Foster: Thank you, sir. Appreciate your time. 

Harris Bixler: All done?

John Foster: Yep. Thank you. Oh, oo. Beth Unger is up at the moment followed by Joanne, 

Joanne Tobacman please.

Beth Unger: Good afternoon. I am Beth Unger. I work with CROPP Cooperative. It is a farmer 

owned cooperative with over 1700 farmer members marketing products under the 

Organic Valley and Organic Prairie brand names. I have two topics I wanted to cover 

today, carrageenan and cellulose. I want to express a great deal of appreciation to the 

depth of the work that the Handling Committee has done in looking at carrageenan. I was 

really impressed with the, all of the dialogue that was going on earlier when you were 

presenting the substance. Harold, I think that your first meeting on the National Organic 

Standards Board and I was very impressed in the way you dialed right in on the fact that 

although the comments were substantially against the relisting of carrageenan, that you 

were able to see that a lot of these comments were what I would call a cut-and-paste 

variety, even to the extent where the same punctuation error existed in many of the 

comments. Yes, I read all of the comments as I am sure every one of you did. So and, 

Zea, you know, the work that you did in your research, you know, it, it totally changed 

what I was going to say to you all today be I wanted to caution you about, you know, the 

varying types of studies and, you know, I think that is true in anything that you want to 
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91

look at, you can find stuff to, you know, studies that are funded by somebody to express 

the results that you want to see. And you can see that in the public comment that had 

some substance to them. So I really appreciate that. But I did want you to know that we 

do you use carrageenan in some of our products. We are also working to not have 

carrageenan in our products but there are certain functional effects that we cannot do 

without. Oh, my gosh, I got to get to cellulose. Heavy, you know, the UHG heavy cream, 

there is no substitute. And the chocolate milk as a stabilizer, there is no substitute. And I 

am going to move right into cellulose. I was shocked. I did not include it in my written

comment, because I had no idea that this was an evil synthetic. It is not. It is a ubiquitous 

thing. We use it in our shredded cheese and in our Parmesan and there, rice cells will not 

do it. We need it. Please, relist it. I am, I am fully in support of the recommendations the 

Handling Committee put on the table. 

John Foster: Thank you, Beth. Is there a question? Colehour.

Colehour Bondera: Yeah, thank you for your testimony. And I, could you expand very briefly 

on, I, I guess I wrote it down, sorry but you said that you are working to have no 

carrageenan in your products ...

Beth Unger: Yes.

Colehour Bondera: ... when you gave that, and I was curious, why? 

Beth Unger: Thank you, that was going to be in there in the five-minute version. 

Crowd: [Laughs] 

Beth Unger: I cannot remember how many years ago, but there was some concern brought 

forward about carrageenan and we have a, well I want to backup for just a moment, 

Colehour, because at CROPP we really want to formulate our products to be as clean as 

they possibly can. This has always been the case and we worked very hard to ensure that, 

that the formulations are, you know, filled with certified organic ingredients to the extent 

possible. So there is constantly product development work going on to improve our 

product formulations. And, you know, I have a number of examples of that. But two 

products, it is out of the eggnog. It was used in the eggnog as a, yeah, to ...

Unknown Female: [Inaudible].

Beth Unger: ... keep the little nutmeg things all floating around nice. 

Crowd: [Laughs].

Beth Unger: And then we also have it in our soy beverages, not our soy creamers, but our soy 

beverages. Our product development team has been working on getting that out of the 

soy beverages for a long time now. This is not, this is a challenge. It is a huge challenge. I 

think that they are getting close. I believe that we are going to be going to plant trials and 
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92

that, for that, some new formulations. But the, the terrifying thing about that is, and I am 

not sure what material they are trying to replace the carrageenan with, but it is something 

else on 605. And it, you know, is like, it is like rolling the dice when you cannot take a 

material that is on 605 out of a formulation and use another one because that will be, it, it 

is expensive to keep reformulating, you know, and trying to do the best, cleanest products 

possible and wondering, you know, what is the next thing to go. 

John Foster: Thank you. Jay, then we have got to wrap it up.

Jay Feldman: Yeah, just quickly. Thank you, Beth. Try to go back to the nasty cellulose

[inaudible]. 

Beth Unger: Yeah, yeah. [Laugh].

Jay Feldman: You know, a lot of this stuff is a surprise to a lot of us. I am just wondering if you 

would feel okay with an, an annotation that is specifically focused on the, the 

microcrystalline material. 

Beth Unger: No problem, yeah. We use the powdered. 

Jay Feldman: Thank you. 

John Foster: Thank you, Beth, very much. Alright, let me... We have Joanne Tobacman, 

followed by Britt Lundgren. 

Joanne Tobacman: Okay. Good afternoon members of the National Organic Standards Board and 

other meeting attendees. I am a physician/scientist at the University of Illinois College of 

Medicine who has been studying the effects of carrageenan in human cells and in animal 

models for almost two decades. I am a graduate of Harvard University Case Western 

Reserve University School of Medicine trained at the NIH and the CI, and I am Board 

Certified in internal medicine. With collaborators, I have published 19 peer-reviewed 

papers that address the biological effects of carrageenan. Most of this work has been 

funded by the NIH and the Veterans Administration. I will address three major points. 

First, exposure to carrageenan causes inflammation which is harmful. Second, the amount 

of carrageenan consumed in the human diet is sufficient to cause inflammation. And 

third, both un-degraded and degraded carrageenan cause inflammation. Carrageenan is 

used in food due to its potent chemical effects that improve the texture of food products. 

But carrageenan has no nutritional value. The same potent chemical effects that change 

the texture of processed foods can lead to harmful biological effects in human cells and in 

animals exposed to carrageenan. Carrageenan has been used in thousands of biological 

experiments over several decades because it predictably causes inflammation. 

Inflammation is well known to be the basis for many human diseases and is associated 

with over a, a hundred human diseases, including inflammatory bowel disease, 

rheumatoid arthritis, arteriosclerosis and inflammation is also linked to cancer. In 

experiments with human colonic cells in my laboratory, we do small amounts of high 

molecular weight carrageenan and yet determine the specific molecular mechanisms by 

Comment [JMS27]: 07:00:00
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93

which carrageenan causes inflammation. There are three major pathways by which 

carrageenan causes inflammation including stimulation of an innate immune pathway. 

This pathway is also activated by pathogenic bacteria such as salmonella and is 

stimulated due to the unusual chemical structure of carrageenan. Stimulation of this 

pathway is no accident. It is a direct result of the unusual chemical structure of 

carrageenan including an alpha-1, 3 galactosidic [glycosidic] linkage. And stimulation of 

this pathway has features that can lead to prolonged inflammatory effects in human cells. 

The effects of carragan [carrageenan] induced inflammation are not limited to the 

intestine. And when laboratory mice were exposed to low concentrations of carrageenan 

in their food for eighteen days, they developed profound glucose intolerance and 

impaired insulin action. These responses are precursors of diabetes which is associated 

with activation of the innate immune pathway. In the past many investigators used

carrageenan to cause inflammation to study how specific drugs could reduce 

inflammation and to study the cells and cell products involved in the inflammatory 

response. Our recent work has looked instead within cells to study the signaling processes 

caused by carrageenan exposure and we have found convincing evidence that 

carrageenan activates biologically significant pathways. Some of these effects are related 

to activation of reactive oxygen species, reduction activity of sulfatase enzymes, and

activation of genes involved in carcinogenesis. Quantitative assessment of these is 

included in your written materials. I guess I am supposed to stop. I would like to go on. 

Does someone want to ask me a question?

Crowd: [Laughs],

John Foster: Alright. As [inaudible].

Joanne Tobacman: See maybe you would ask me a question? I was very upset by the comments

this morning that were based on literature from industry. Two out of three of the papers 

that you referred to were industry based. That was very disappointing. 

John Foster: So I, my inclination is to have our scientist member go, go first. 

Zea Sonnabend: Okay. I actually have two questions ...

Joanne Tobacman: Yes?

Zea Sonnabend: ... for you. And I would like you to continue but address why the other 

scientists in those papers, of which there were considerable number of citations, of, 

thought, criticize your work so much. 

Joanne Tobacman: Well, I think you have to look at the date of things. My work is originally a 

review. In 2001, I wrote a review of carrageenan. That is rather hard to, it seems to me, to 

criticize. I think industry was very upset about the review because it showed that undegraded carrageenan also had profound effects. And in general, the feeling has been to 

try and separate the effects of degraded and un-degraded carrageenan. And that has been 

a decoy argument for years within the industry because the, in our experiments we used 
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94

un-degraded carrageenan. The structure of un-degraded carrageenan contains this 

biologically active component in each of the disaccharide molecules and this is an 

inflammatory inducing chemical composition. You cannot get away from that. And that 

is present in the un-degraded and the degraded. There is a lot of reluctance to accept this. 

People have been using carrageenan successfully in food products for decades. But that 

does not mean it is safe. We have a lot of unexplained human disease. 

John Foster: Uh, but, ... 

Joanne Tobacman: And our only hope is to be able to find ways of getting, of understanding it 

better. And I think the inflammation caused by carrageenan is a real factor in human 

disease and I think that you as the Organic Standards Board have a wonderful opportunity 

to improve the safety of organic foods in this country.

John Foster: Uh, okay. I got a, hold on a second. Zea, I am going to finish with you. 

Zea Sonnabend: I did have a second question. 

John Foster: Is it, it is follow-up or is it new? 

Zea Sonnabend: It is a different question. 

John Foster: Alright, is it okay if I wrap up with you?

Zea Sonnabend: Alright.

John Foster: Okay, thanks. So I had out of the corner of my eye, Calvin. I saw some hands down 

here to my left. 

Unknown Male: Jennifer.

John Foster: Jennifer and Mac. 

Unknown Male: No, Nick.

John Foster: We are obviously going to go a little bit longer on this particular commenter, so. I 

am sorry, Nick after Jennifer. 

Calvin Walker: I am, I am impressed as an M.D. you have 19 refereed publications. That is, that 

is very good. You mentioned grants from NIH, which is a big name organization. Were 

those grants that you received peer-reviewed as relates to ...?

Joanne Tobacman: All, all of the grants that we have had to be, that fund carrageenan work have 

been peer-reviewed. Some of it has been to fund inflammation. I do not want to make it 

sound that all of those were specifically for carrageenan. It was to fund infla-, work on 

inflammation as well. 
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John Foster: Alright. Jennifer.

Jennifer Taylor: [Inaudible] Were you able within the questions as they asked to complete your 

presentation of information today? 

Joanne Tobacman: I had wanted to be able to – thank you for asking that – I wanted to be able to 

make a specific comment about why the Board is uniquely positioned at this time to 

make a determination when previous evidence could not have been as convincing. And I 

think the Marinalg work in 2006 with the round-robin analysis of food-grade carrageenan 

in which they showed a lot of variability among the food manufacturers in determination 

of the molecular weight of the low molecular weight component of the food-grade 

carrageenan ranging up to 25 percent in food-grade carrageenan that was being put into 

the processed food that would then be used into the final food product. Up to 25%. This 

is low molecular weight, under 50,000 is what they were using as the cut off in response 

to the European Union. So that is a lot. If, if you are still going to go by the argument that 

the degraded polygeenan is carcinogenic and that this is what we should be avoiding, 

which was the argument brought to the FDA in 1972, when they were ready to say, no 

more than 10 percent of molecular weight less than 100,000 as a regulation. But, so, that 

is a unique change that that was, that material became available in 2006 in response to the 

European Union recommendation. So we have from industry itself that they cannot 

supply a food-grade carrageenan that is free of low-weight molecular carrageenan 

[inaudible]. And that is a new finding that you have the opportunity to act upon. Okay, 

that was mainly what I want to say.

John Foster: And then I believe Jay and we will finish up with Zea.

Jay Feldman: I, yes, I am going to ask a question about your views on, on carrageenan with 

relationship to what the FDA has found and what the charge of this Board is – and this 

may or may not make sense to you as a question, so if, if it does not, then I will 

understand. We, we are charged with looking at the impact on human health and the 

environment. FDA is charged with looking at food safety. In your, if you were to evaluate 

this product for us, versus if FDA asked for an evaluation, would you be evaluating it by 

the same standard or do you feel that we, we see, we are held to a, a different standard? 

Joanne Tobacman: I am not sure that I have enough experience with the underlying annotations 

and regulations that you are dealing with to be able to answer that as well as I would like 

to. I, I would say that there is an environmental aspect of the carrageenan farming that 

has not really been dealt with substantively now that there has been a consideration in the 

past and we wrote a letter to Science about this about a year or so ago in response to 

damage to coral reefs occurring in the Bay of Bengal and someplace else, Pacific Atolls, 

Pacific Islands. There was significant damage to coral reefs and that was thought to be 

related to overgrowth of carrageenan-producing algae or red algae that would make 

carrageenan. So there is potentially an environmental impact. In terms of health versus 

safety, I, I do not know that I see those as all that much different. I think that the criteria 

for inflammation is a, a significant one since inflammation is a precursor for so much 
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human disease and I think that can be taken into consideration both in terms of organic 

foods and from the FDA’s point of view. 

John Foster: Thank you. We have got Jay and then Zea.

Jay Feldman: [Inaudible] Have you, thank you. Have you fully explained the mechanism for 

inflammation in your recent work? Is that, do you need more explanation of that in terms 

of bringing new information to this Board that, that needs to be considered? And then, do 

you feel that levels, because I understand FDA has set a level, a level for degraded 

carrageenan. How did they get to that level and what are the deficiencies in that process 

in light of the kind of research that you are doing? 

Joanne Tobacman: FDA proposed a level in 72 of, as I said, less than, no more than 10% of 

molecular weight less than a hundred thousand based on concerns about the harmful 

effects associated with the polygeenan, the low molecular weight. But they rescinded that

in 79 anticipating, actually not saying that carrageenan was safe, they never said

carrageenan was safe. They anticipated a more comprehensive regulation. But I think it 

became a very much a, a deregulatory environment and perhaps more and more food 

conglomerates with political power, speculation there. But they, they have not acted on 

carrageenan in this intervening period of time except with regard to the Philippine drive 

variation but that, that is not a significant issue at this point in time. Terms of 

inflammation, I think we have very well defined the activation of an innate immune 

pathway by carrageenan. This was unexpected. People had, as I said, had used 

carrageenan for, since experiments dating back to at least the 50’s to, because it 

predictably causes inflammation. This is no surprise. This is well known. The same time, 

it has been used increasingly in food products. It is also sort of in a parallel way been 

used increasingly in scientific experiments, but with a, the idea mainly of identifying 

treatments for inflam-, of inflammatory diseases, looking at the medications that would 

be effective to reduce the carrageenan-induced inflammation. So back in our pathways 

looking at the innate immune response were completely unexpected because that puts it 

in a somewhat even more provocative and worrisome light than if it were causing

inflammation by other means.

John Foster: Excuse, excuse me. My, my thought was about literature, more information, was 

that, I lost track. 

Joanne Tobacman: It [inaudible].

John Foster: See I, I am trying, boy, it is a tough crowd to wrangle. I got to tell you. This, Jay, as 

I understand it you wanted to know more about what more information was needed, 

right?

Jay Feldman: Yeah, I, I was thinking that she had, her more recent research on inflammation ...

John Foster: Got it. Okay.
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Jay Feldman: ... was, would be helpful to the Board. 

John Foster: Okay. Thanks. 

Joanne Tobacman: Were there other questions?

John Foster: And then Zea. You are going to bat clean-up.

Zea Sonnabend: Okay and my question is complicated so bear with me. Your review contained, 

your 2001 review contained a variety of studies, some of which involved feeding, some 

of which involved water administering the carrageenan, and some of which involved 

injection and other methods. And the testi-, what I read this morning indicated concerns 

that injection and especially of higher doses was not necessarily a valid way to do 

research on this and water studies, where it was administered in water were not 

necessarily accurate for doing research because when the carrageenan enters your body, 

when you consume it in a product, it has already formed a gel and the gel colloid is more 

stable once it reaches the human digestive system than a in vitro cell study or a water 

study or an injection type of study and could you comment on, first of all, the range of 

types of studies in your review? If that, if I characterized that accurately and what 

proportion of studies were what and that perception that once it is in a stable gel, it is not

so easily degraded.

Joanne Tobacman: Alright, I passed out I think the first page from that review which might 

provide some overall sense of ...

Zea Sonnabend: We have, we have the whole thing in public comment.

Joanne Tobacman: Oh, I, okay, good. There were studies in a wide variety of animals. This was 

just the, the studies were selected, they were not in, inclusive of all the studies but they 

were selected because they were well controlled and the amount of carrageenan given 

and the route, everything was clear. So these were highly selected studies that showed 

significant harmful effects on the gastrointestinal, development of gastrointestinal 

lesions. I, I am not sure that this needs to be taken as the last word. There are on-going 

studies of the harmful effects of carrageenan. Now, whether or not you look at the gel 

product that is included in food, well, when you drink chocolate milk that has 

carrageenan, there is no noticeable gel obviously and there is also this presence of a fair 

amount, up to 25 percent we have said, of degraded carrageenan. So some of the 

carrageenan that is incorporated into that final product is not in gel form, since the low 

molecular weight form is not going to form gel. But lambda is non-gel forming. It is also 

used very commonly in the, in food and, and considered in the annotation now as a 

separate product. So, lambda is non-gel forming so that does not partake of the issues 

with regard to the kappa and the iota. 

Zea Sonnabend: And studies with lambda were in your, part of your review? 

Joanne Tobacman: Oh, yes, yes. I am not sure what other specific question you might have. 

Comment [JMS28]: 07:15:00
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98

Zea Sonnabend: It was: what proportion of the studies that you did review were in vitro versus 

feeding studies versus the tumor injection kind of studies?

Joanne Tobacman: Well, the study in the, in the review were all animal studies. I did not use any, 

there were no in vitro studies in the, in the review. And in terms of the injection studies, I, 

I avoided much analysis of those because those are more alarming. They include 

development of mammary cancers from injectable carrageenan. I do not really want to 

get into that until we have better information. But I think this is a very harmful substance 

and there is just no reason for it to be there. The, the products can be made with different 

formulae. Shaking probably does work for some of the chocolate milk and it would be 

wonderful to get this out of our human exposure. So.

John Foster: Alright, we are going to wrap it up. Thanks.

Joanne Tobacman: Thank you for the opportunity to speak.

John Foster: Next up we have Britt Lundgren, followed by Robert Rankin on deck. 

Britt Lundgren: Thank you for the opportunity to comment today and thank you to the Board for 

all of your diligent work. Are we on? There we go. Alright, so anyway, thank you for this 

opportunity. My name is Britt Lundgren. I am the Director of Organic and Sustainable 

Agriculture at Stonyfield. I am going to be commenting today on behalf of Stonyfield on 

the Handling Committee's proposal for carrageenan. And we wish to express support for 

the Handling Committee's recommendation of relisting carrageenan and also like to note 

our support for the comments heard earlier from Beth Unger of Organic Valley and for 

the comments that were submitted by White Wave and by OTA. Stonyfield was founded 

in 1983 with seven cows and the goal of helping family farmers survive and protecting 

the environment. Today we are the world's largest, largest leading, world’s largest 

organic yogurt producer. Our volume of production allows us to support enough family 

farms to keep over 200,000 acres of farmland in organic production. And this avoids the 

use of 210,000 pounds of toxic persistent pesticides and nearly half a million animal drug 

and hormone treatments annually. We are committed to meeting consumer expectations 

for a pure organic product that is free from unnecessary artificial ingredients, flavors, and 

fillers. We are also fully committed to the concept of continual improvement in the 

organic standard. We believe that the Sunset process is a valuable tool for facilitating this 

continual improvement. As we well know by this point in the day, concerns have recently 

been raised about whether carrageenan has negative impacts on human health. We take 

these concerns very seriously because we want to be sure that we are provided the 

healthiest pros-, possible product. We engaged a scientist to conduct a thorough review of 

the literature with regard to these health impacts and, based on this review, we feel the 

evidence shows that carrageenan is in fact safe to eat. However, I am not an expert on 

this topic and in my comments today I want to stick to Stonyfield’s area of expertise 

which is the process of making yogurt. Stonyfield uses carrageenan in our YoKid 

squeezers and in the caramel in our Oikos caramel yogurt. Carrageenan provides a critical 

function in each of these products, creating a unique combination of stability, texture, and 
Meeting Of The National Organic Standards Board

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99

mouth feel. To our knowledge, there are no commercially available organic ingredients 

that could replace the functionality of carrageenan in these products. The ingredients 

suggested as alternatives in the technical report do not provide both the structural and 

sensory properties that we are seeking. Some of the alternate ingredients suggested in the 

technical report may provide some of the properties that we are looking for but, as far as 

we have been able to determine, none of them can provide all of these properties, either 

alone or in combination. We also do not know if these alternative materials suggested in 

the technical report are available in sufficient quantity in organic form to meet our need 

and if it turned out that we could use a combination of them as, if we could use a 

combination of them as a substitute. So we are very concerned that if this ingredient is 

removed from the National List, that we will no longer be able to offer the products that 

contain carrageenan to our customers and this will have a substantial negative impact our 

business. I urge you not to remove carrageenan from the National List at this point in 

time. Thanks. I will take questions.

John Foster: Thank you, Britt. Is there a question? Mac. 

Mac Stone: Does carrageenan show up on the label of your yogurt? 

Britt Lundgren: Yes.

Mac Stone: Okay.

John Foster: Joe.

Joe Dickson: So, if carrageenan were to go off the List, what would happen? Would you

reformulate the products with something else? Would they become conventional 

products? Would they disappear from the market? Like what, assuming it went off the 

List at this meeting, would the impact on your business be? 

Britt Lundgren: Well, we are investigating whether we could reformulate. We do want to be 

responsive to consumer concern and so we are, we are looking to see whether we could

take carrageenan out of our product, but as I said, we really have not been able to find 

anything else that we could use in place of it. So we may just have to pull the squeezers 

and the caramel Oikos from the market.

John Foster: Okay, I have Jennifer, Nick [laugh]. Jennifer and Nick for sure.

Jennifer Taylor: Hi. I like for you to tell me as a representative from your company, an organic 

company, how and where do you place the health of the community that you are serving 

with the new knowledge that you now have maybe about carrageenan?

Britt Lundgren: As I said, we prioritize the health of our consumers very highly. Stonyfield's 

mission is healthy planet, healthy business, healthy food, and healthy people and we take 

all four of those “healthy”s very seriously. We do not put one of them, any one of them 

above the other. That is why we conducted the literature review that we did and that is 
Meeting Of The National Organic Standards Board

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100

why we continue to investigate this issue. But as I said, we feel confident that the 

literature does conclude that carrageenan is safe to eat.

John Foster: Thanks. Nick.

Nick Maravell: Yes. This is a follow-up to some of Joe’s questions. What would, you have two 

products that use the carrageenan now?

Britt Lundgren: Yep.

Nick Maravell: Roughly, what percentage of, of your business do those two products represent? 

You know, I mean, ballpark figure. We are not going to hold you to it. 5%? 50%? 1%?

Britt Lundgren: I was afraid someone was going to ask that. I do not know. It is, they are very 

popular products. The, the squeezers represent a growing product line for us. And the 

caramel Oikos is a, is a very popular flavor of our Greek yogurt. But of course, we have 

probably over 60 products on the market right now and that is two of those products. 

Nick Maravell: That is what, okay. And then could you just give us a, sort of a rough idea, if 

you, if you were, you seem to be constantly coming up with new products and you are 

consid-, you would consider reformulation if that were, if carrageenan were not available. 

How long does that process take, you know, to develop the reformulation of market 

tested, and things like that? Are we talking weeks, months, years, in order to, to

accomplish that? 

Britt Lundgren: Well, the reformulation process is, varies depending on what it is that you are 

trying to do. And in a situation like this one, where the ingredient is, is important for the 

fundamental constitution of the product, it, we are concerned that it could actually take 

years. And in my written comments, you will see that I, I do request that if the Committee 

does choose to de-list carrageenan, that we ask that you recommend extending the Sunset 

date past November 2013 to November 2015 to give us adequate time to reformulate 

because we really have no idea what, what else we would use in those products. 

John Foster: Alright, I believe that is it. Thank you very much. 

Britt Lundgren: Thanks.

Unknown Male: We probably ought to take a break at some time.

John Foster: Okay. We have Robert Rankin and then followed by Zareb Herman.

Robert Rankin: Thank you very much. Good afternoon. My name is Robert Rankin. I am 

Associate Director at the International Formula Council. The IFC is an association of 

manufacturers and marketers of formulated nutrition products including infant formula. 

These comments are on behalf of IFC members who manufacture organic infant formula 

as well as the Hain Celestial Group which is not an IFC member but is in the organic 
Meeting Of The National Organic Standards Board

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101

infant formula market. The IFC supports the continued use of all substances currently 

allowed as ingredients in infant formula products labeled as “organic” or “made with 

organic”, including choline, inositol, and carrageenan. These substances have been 

reviewed by the US Food and Drug Administration for their safety and suitability for 

infants. The IFC strongly supports the Handling Committee's recommendations to add 

choline and inositol to the National List at 205.605(b) for use in organic infant formula. 

Manufacturers, they follow US law and the law that was talked about a little bit earlier, 

the US Infant Formula Act, requires that choline and inositol are present in infant

formula. I have here a copy of the Infant Formula Act which was codified in 1980 and 

which I am happy to share with the NOSB and the NOP following my comments. It 

includes a table which lists all of the nutrients that are considered essential and that must 

be present in infant formula. Choline and inositol are both listed on here as required 

nutrients. There is a footnote which specifies that this is for non-dairy infant formulas, so 

all non-dairy formulas must contain these levels. So those products must be fortified. In 

regards to milk-based infant formulas, at the time that this law was codified in 1980, the 

general consensus was, or the thinking was that cows’ milk provided that level of choline 

and inositol such that those products do not need to be fortified, so it is not mentioned in 

the Infant Formula Act. However subsequent regulations, which I believe were I guess 

codified in 1984, reflected research and development from the manufactures which

showed that the levels of choline and inositol in milk-based infant formulas is variable.

So in order to make that level that is required for soy-based or non-milk-based infant

formulas, those products are fortified by the manufacturer. And if a product is fortified, a 

milk-based product is fortified or soy-based, that must be shown on the label. And of 

course that goes back to the law so that if a, if a government or whoever is looking at the 

fortification of that product and it does not contain those levels, it would be considered 

misbranded, adulterated, and it would have to be pulled off the market. I also wanted to 

speak to the support for carrageenan. Carrageenan again is a, is a substance that US

manufacturers look towards US regulations for and, as has been said before today, the US 

Food and Drug Administration which governs the safety of, of foods in the US has said 

that carrageenan is safe for consumption by infants. And there is also a very long history 

of safe use of carrageenan in liquid infant formulas. Excuse, me, I am just skipping

around a little bit here. In the event that, well, thanks. 

John Foster: Ah, yes, Jay and then Calvin.

Jay Feldman: Thank you for that. It is very helpful. I, I am trying to understand the process. You, 

you, it starts with, you did explain it to some degree that, you know, the Acts passed and 

then a decade later, whatever, new information comes along, there is a proposed 

rulemaking to change the levels or in, include additional nutrients on the mandated, or 

required list. What is the process by which you would seek to get a nutrient or 

fortification on the list, on the mandated, required list as it is in that Infant Formula. 

Does, I, I do not imagine it takes an Act of Congress to do that. What would, what would

the process be and why has not, why has not that process been completed with regard to, 

you know, inositol, choline in infant formula?
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102

Robert Rankin: Well, I, I do not think I could speak to why it has not happened, but to your first 

question, one would have to approach the FDA, which, which implements that law and 

through a conversation I guess with FDA and Education or what have you, they 

potentially could agree to reopen that and discuss the essentiality of nutrients. In terms of 

the, the levels and, and what is in the products, the law requires that it is in the non-milkbased infant formulas. And as I said before, after 1980 through continuous research and 

development it was determined that the levels in the milk-based products are variable. So 

some are below that level; some are above that level. And in order to ensure that those 

levels are what they should be, those manufacturers fortify. And if those manufacturers 

fortify, they have to label it. And if it is labeled, then you have to be able to guarantee

that it is in the product and to cover yourself against the law. 

John Foster: Alright. Calvin.

Calvin Walker: I did not hear the last part of your statement. You said something about in the 

event, and you was cut off.

Robert Rankin. Yes. Thank you. I appreciate that. What I was going to say is that if choline and 

inositol were, were not allowed to be present in organic infant formulas, we believe those 

products would have a nutritional disadvantage as well as a competitive disadvantage 

against non-organic products which do not have, they are allowed to formulate with those 

nutrients. And in the event that organic infant formulas cannot compete with nonconventional or conventional infant formulas, then that would, I think the manufacturers 

would, would have to evaluate their presence in the market. I think it would also affect 

consumers who as the gentleman, the local gentleman earlier said, he wants to be able to 

provide organic formulas, organic, excuse me, organic products. And, you know, I think 

that consumers want the most nutritionally adequate product they can get. And knowing 

that these nutrients are required by law for certain products, I would think that they would 

want to have that option for the organic products as well. So it is a, it is a consumer 

preference issue and it is a, a competitive issue or I guess it is a presence in the market 

issue from the manufacturers’ point of view. Also with regards to carrageenan, I did want 

to also say that if that is no longer allowed in organic liquid infant formulas, that would 

also result in potentially a disruption in the market for those particular products and it

would also I think force the manufacturers to re-evaluate their presence the market as 

well just because of the process that would have to be undergone to, to replace 

carrageenan. 

John Foster: Alright. Thank you very much. Short. Real short, Nick. 

Nick Maravell: You said choline and inositol were in milk-based formulations where it was very 

variable. It could be high. It could be low. And it could be below recommended rates. Is 

there any information on what that variability is caused by? What are the factors that 

contribute to it?

Robert Rankin: It is, it is just the naturally occurring presence of those nutrients in cows’ milk 

and again in 1980 the assumption was that milk delivered that amount. Subsequent 

Comment [JMS29]: 07:30:00
Meeting Of The National Organic Standards Board

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103

research showed that it varies. Some were low. Some were high. I mean I think it 

depends on the animal. And then, so then to, to address that, the products were fortified at 

a level to make sure they were at the, the level. 

John Foster: Thanks very much for your time. 

Richard Rankin: Thank you.

John Foster: Zareb Herman and then we had a request to take a break which sounds like a pretty 

good idea to me. 

Zareb Herman: My name is Zareb Herman. I am a nutritionist and food scientist with the Hain 

Celestial Group. We have been producing natural and organic foods for over 40 years. 

We wish to strongly support the Handling Committee’s recommendation to re-list 

carrageenan on 205.605(a). Carrageenan is an ensen-, essential ingredient derived from 

seaweed and it is used in thousands of organic products. Carrageenan is unique. Its 

unique characteristics are not matched by any other substance. And in many applications, 

it cannot be replaced by any other substance. Carrageenan is often used in combination 

with gums, starches, and emulsifiers. It has taken years of research to develop these 

combinations for specific applications in organic products and carrageenan is essential in 

these applications. On safety, the FDA has determined that carrageenan is GRAS or

generally recognized as safe for direct addition to food for human consumption. And has 

already been stated, carragan [carrageenan] is all, is also been determined to be, be safe

by Health Canada and the FAO-WHO Joint Evaluation Committee for Food Additives. 

Arguments questioning the safety of carrageenan are based primarily on animal studies 

that do not reflect the way that humans consume food-grade carrageenan. Also, in vitro

studies of human cells that have been taken out of the body and soaked in carrageenan 

solutions have little relevance to how cells operate inside the body. It is a huge stretch to 

take these selected studies and then claim that food-grade carrageenan is harmful to live 

human beings. Such a stretch [strategy] ignores the most important studies in which 

food-grade carrageenan was fed to animals with no adverse health effects. There are also 

no studies whatsoever showing adverse effects on, on live humans who have consumed 

foods that contain food-grade carrageenan. Today you are hearing a lot of arguments for 

and against the safety of carrageenan. If you are not a scientist, and maybe even if you 

are, you may have difficulty deciding. The good thing is, you do not have to. The FDA

has already determined that carrageenan is safe. The FDA has the legal authority to 

determine the safety of food ingredients in the United States. It is amazing that some

people think that they know better than the scientific experts at the FDA, Health Canada 

and other international authorities. Carrageenan is safe. And it is essential for organic 

handling. I urge the Board to not react to unfounded claims about the safety of 

carrageenan. A “no” vote is totally unwarranted and would have a devastating impact on 

the organic industry. Thank you.

John Foster: Thank you. Do we have questions? We must have got it, must have answered them 

all already. Okay. Thank you very much. We are going to take a, Barry, I will hand it 

over for taking the break.
Meeting Of The National Organic Standards Board

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104

Barry Flamm: We will take a 15 minute break. Be back here at, what, three, four, 3:55. 

[BREAK]

Barry Flamm: It is still turned off. They got me turned off. [Laugh] Hey, Ben? Hey, Mac, get 

Ben to turn me on.

Unknown Male: You are on. You are on.

Barry Flamm: Am I on? I was not. Board members, please take your seat. I did not, I did not hear 

myself.

Unknown Male: Yeah, I, I was right by the speakers. 

Barry Flamm: You heard it?

Unknown Male: Yeah.

Barry Flamm: Oh, I thought you turned me off. [Laugh]

Unknown Male: [Laugh]

Barry Flamm: I thought maybe you turned me off, Ben, because all of a [inaudible].

Unknown Male: We do during the break. We turned you back on.

Barry Flamm: Oh, okay. Thanks, man. 

Unknown Male: Can you go ahead and make that announcement again about what we were 

discussing? They are doing great but just to reiterate. 

Barry Flamm: Oh, okay, I will do it right now. Where is everybody? They are not paying much 

attention to my...

Unknown Male: We are almost at quorum, sir.

Barry Flamm: Huh?

Unknown Male: We are almost at quorum.

Barry Flamm: Hey, Nick. Jay. Calvin. 

Unknown Male: Sit down so we will be at quorum. 

Comment [JMS30]: 07:37:07

Comment [JMS31]: 07:52:58
Meeting Of The National Organic Standards Board

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105

Barry Flamm: I would like to remind the Board members that when you are having discussions, 

particularly with, or questions with, with your neighbor, or close by, to speak in at all 

times, speak into your microphone please. It is, this is just a reminder. John, would you 

proceed? 

John Foster: Yep, thank you, Barry. Coming back from the break, next in sequence is Cheryl 

Callen. Thank, and thank you for being on spot on time. Thank you. And on deck is Steve 

Freeman. Steve, you in the room? Excellent. Thank you.

Cheryl Callen: [Inaudible] Thank you. Good afternoon. Is this on? Is that better? Okay. My name 

is Cheryl Callen. I am representing Nestlé Infant Nutrition. We currently market organic 

baby foods and toddler foods and infant cereal under the Gerber brand. And many of 

these organic foods currently have added choline. As one of the petitioners to add choline 

to the National List, we are here today to lend our support to the Handling Committee's 

recommendation to allow for the addition of choline to organic infant formulas. We are

also here to encourage the Board to reconsider the recommendation to only allow choline 

addition to adult food made with organic ingredients. We are asking the Board to 

specifically consider the addition of choline for foods positioned specifically for infants 

and toddlers, including infant cereal which is commonly fortified with vitamins and 

minerals. I would like to briefly review for the Committee some of the points we made in 

our written comments. Choline is important for cell function and there is substantial 

evidence indicating that choline plays a role in brain development and function. Adequate 

choline is important in periods of rapid growth and development including infancy and 

early childhood and is important for optimal fetal development during pregnancy. In 

1998, the Food and Nutrition Board of the Institute of Medicine recognized choline as an 

essential nutrient and established adequate intake levels, or AIs, for population groups 

including infants, young children, and pregnant women. Prior to 2005, little data were

available on choline intakes in the US population. Starting in 2005, the INHANE surveys 

estimated choline intakes. Mean intakes for men and women are below the recommended 

AIs established by the Institute of Medicine. And especially concerning, is that the mean 

intake for women is 40% below the AI. The Nestlé Feeding Infants and Toddler Study, or 

FITS, is the most comprehensive dietary intake survey of infants and young children in 

the United States with a sample size of over 3000 children between the ages of zero and 

48 months. Data from FITS shows choline intakes for infants are below the AI with over 

75% of children ages seven to 12 months below the adequate intake levels. For toddlers, 

12 to 24 months, 66% have intakes below the AI. The Handling Committee 

recommendation states that the addition of choline is not harmful and that there are no 

adverse effects on the environment from the use or manufacture of choline. The 

limitation of choline addition to foods made with organic ingredients seems largely based 

on the availability of food sources for choline. Clearly based on the surveys done by both 

USDA and Nestlé, a significant portion of the population, both adults and children, are 

not getting choline from available food sources. I am not aware of any data to indicate 

that organic consumers are faring any better, or even are aware that they need to modify 

their diets to achieve adequate intakes of choline for themselves and their children. Given 

the low levels of intake, especially concerning for pregnancy and for infants and children 

during development, we urge the Board to consider allowing the addition of choline to 
Meeting Of The National Organic Standards Board

May 24, 2012

106

organic foods and specifically for foods intended for infants, such as infant cereal. 

Consumers of organic food should have the option to choose foods with this important 

nutrient. Thank you. I will take any questions. 

John Foster: We the, do you have a question?

Cheryl Callen: Any questions?

John Foster: Alright. Thank you very much. 

Cheryl Callen: Okay. Thank you.

Jay Feldman: I had a question. 

John Foster: Oh. 

Jay Feldman: Just a quick question. I am sorry. I was waiting to see if there were any others. 

Thank you. I have a whole lot of questions. I am going to cut back to one. Do you guys 

measure, I am assuming in the milk-based infant formula, liquid formula, do you measure 

levels of choline and inositol before you add? 

Cheryl Callen: Actually, I am not, we do not make an organic infant formula. We only make 

organic baby foods and toddler foods. Mean in our, we do...

Jay Feldman: In your conventional line.

Cheryl Callen: We do make a conventional infant formula, yes.

Jay Feldman: Right. And do you, do you test for levels before you add? 

Cheryl Callen: Yes, we do. We test our incoming ingredients for naturally occurring nutrients

and then our formulations are developed to assure, as was said earlier, to assure adequate 

intakes of choline in the final formulation. 

Jay Feldman: Thank you.

John Foster: Thank you very much. Appreciate it.

Cheryl Callen: Yes, thank you. 

John Foster: We have Steve Freeman and then Kelly Shea is on deck. 

Steve Freeman: I do not need the box. Good afternoon and thank you for having this opportunity 

to express. I am here today on behalf of Jackson Farms, a tree fruit producer in central 

California of organic cling peaches and, and thank the Board for its passage of the ability 

to peel peaches with potassium hydroxide at the December 2011 meeting. It is frustrating 

to Mr. Jackson and, and his processors that it is taking so long for this minor amendment. 

Comment [JMS32]: 08:00:00
Meeting Of The National Organic Standards Board

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107

The material is used currently and approved to use for individually quick frozen peaches 

and this would be used for canning peaches and it is taking a very inordinate long time 

for this minor amendment, minor change in the regulations to take place and with harvest 

imminent in the, in the next month or so and him not being able to market his fruit as 

organic canned peaches, he is here to, to implore the Board to ask the, the USDA to get 

this change adopted in a posthaste manner, and I would, I would help get you guys back 

on schedule by that would be the terms of my comments. So, thank you.

John Foster: Thank you. Could, actually we, do we have one question? 

Joe Dickson: Sure.

John Foster: Alright, we have got one question.

Joe Dickson: This is more of a clarification, maybe a question for the Program. My recollection

is that in Savanna we did approve the annotation to allow the additional use of potassium 

hydroxide and it is now with the Program, correct? 

Melissa Bailey: Yeah, that is correct, Joe. So I, I have actually spoken also directly with Mr. 

Jackson before. Appreciate your coming to represent him. We are, what I have expressed 

to him, is that the Board made the recommendation in December. That was transmitted to 

the Program I believe in January. We have it as part of the drafting for a Handling docket 

that we are working on now for a proposed rule that we are trying to get to our General 

Counsel, you know, sometime in June. So, but I did express to him that in terms of rulemaking, these National List amendments do still take our process to get through after the

Board has done its work. So we will continue to, to make progress as, as we can on that. 

Joe Dickson: Thank you. 

John Foster: Thanks very much. Next up we have Kelly Shea followed by Steve Warshower, I 

believe.

Kelly Shea: Hello, welcome to our new NOSB members. My name is Kelly Shea with White 

Wave Foods. We make Horizon Organic and Silk Organic products. Horizon has been 

making organic dairy products since 1991. We are the largest organic dairy brand in the 

US, sourcing organic milk from over 600 farmers across the US. And Silk has been 

making organic soy milk since 1996. It is the largest organic soy brand in North America.

We purchase all our organic soy from US farmers. In transparency, I serve on the Board 

of Directors of the Organic Trade Association. I have in the past served on the Board of 

Directors of OMRI as well as other organic organizations. I have made my living and 

supported my family by working in organic food and farming for almost 25 years. White 

Wave submitted written comments and I am here to reiterate those and to support the

comments of my colleagues at Organic Valley and Stonyfield as well as the many other 

organic food manufacturers, input suppliers and trade associations who are asking that 

this Board renew on the National List carrageenan and cellulose, specifically powdered 

cellulose in our case. These have been used by organic food processors for almost 20 
Meeting Of The National Organic Standards Board

May 24, 2012

108

years. I mean we are actually awaiting organic aquaculture standards so we can have 

organic carrageenan. We have heard and read consumer comments asking that you 

maintain the integrity of the organic standards. Well, relisting these items is maintaining 

that integrity because they are not new to organic. Carrageenan and cellulose have been 

used in organic soy products and other organic products since before the USDA, NOP 

even existed. We have millions of consumer that every day see these ingredients on our 

package labels and choose to purchase them and have for decades. The Federal Register 

notice on Sunset materials published in August of 2011 solicited nothing but positive

comments to re-list these materials. So I do not know where these concerns were at, at

that time. The Handling Subcommittee also unanimously voted to re-list handling 

materials during the Sunset review. So if this Board is contemplating action other than relisting these materials, I really want you to consider something important. Based on the 

positive Federal Register process, the unanimous Handling Subcommittee vote, there are 

many participants in organic agriculture as this is a global program that have not traveled 

to this meeting as they had no idea there was going to be any issue at all with the relisting because all of these things just sort of happened at the 11th hour. And I would just 

like to keep that, you to keep that in mind and I thank you for the time to address you 

today. 

John Foster: Thank you. Do you have any questions? Jean.

Jean Richardson: When you source your carrageenan, what percentage of it comes from wild 

source seaweed as opposed to farmed? 

Kelly Shea: I believe, with speaking from our manufacturers, that it is all wild sourced seaweed.

John Foster: Thank you. Joe? 

Joe Dickson: On the sort of necessity angle, can you speak a bit to what would happen within

your business and your product line if carrageenan were to go off of the list? Would there 

be, where would there be opportunities for reformulation and where would products 

disappear from the marketplace? 

Kelly Shea: Sure, we have a really robust R&D department and they are little research monkeys 

that love to do nothing more than discover new ways to make really cool, awesome food. 

And we are constantly trying to not use things that are on 605(a) and (b) and 606 because 

it is really like Russian roulette. It takes a couple of years to formulate a product and then

you have really only got two years left of it on the National List before it is up for Sunset 

again. So our R&D department really likes it when they are not using things on the 

National List. But, for many products, for example for our soy milks as Britt from 

Stonyfield said, in our Tuberz Yogurts, as Beth had commented in our chocolate milks, 

carrageenan is just very uniquely positioned to work in those products and that is why it 

is so ubiquitous in so many food products and I have never before heard these types of 

concerns that we are hearing today. It has been boldly labeled our packages since about 

1993 in the case of Horizon. 
Meeting Of The National Organic Standards Board

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109

John Foster: Thank you. Yep. Joe. 

Joe Dickson: Totally different question, on the cellulose issue, would you support an annotation 

that excludes microcrystalline cellulose?

Kelly Shea: Absolutely. It has been the understanding of the organic community that that has

always been prohibited. We use a powdered cellulose in our cheese shreds. 

Joe Dickson: Thank you. Jay.

Jay Feldman: Thanks, Kelly and thanks for your support on the GMO letter. Appreciate that.

Kelly Shea: Always.

Jay Feldman: I was curious in terms of the product lines that would be affected by ...

Kelly Shea: Mm-hum.

Jay Feldman: ... carrageenan and so far I have heard about chocolate milk and ultra-pasteurized 

whipping cream and I am wondering is there something unique to the ultra-pasteurized 

whipping cream that requires it in that, but not in the, on the pasteurized line?

Kelly Shea: I do not know the answer to that. I am not a food scientist. Maybe somebody else in 

the room can speak to that. 

Jay Feldman: Okay, thank you.

Kelly Shea: Sorry, Jay.

Jay Feldman: That is okay. 

Kelly Shea: I am a theater major. 

Crowd: [Laughs]. 

Unknown Male: Perform very well. 

Crowd: [Laughs] 

Kelly Shea: It is because it is what I believe in, much like yourself, I am sure. 

John Foster: I think we have a question from Jennifer. 

Jennifer Taylor: [Inaudible]. I am sorry. Hi. Is it possible to use, is it called comm-bu, k-o-m-b-u 

seaweed instead of the carrageenan that you are using? 
Meeting Of The National Organic Standards Board

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110

Kelly Shea: I am only familiar with kombu from eating it in Japanese food.

Jennifer Taylor: Yes. 

Kelly Shea: And it is, I love kombu salad.

Jennifer Taylor: Yes. 

Kelly Shea: But I have never known it to my knowledge to be a thickener for use in food 

products. 

Jennifer Taylor: Okay.

Kelly Shea: Much like wakame is the one around ...

Jennifer Taylor: Right. 

Kelly Shea: ... the sushi, I have never known that to be a thickener for use in food products 

either.

John Foster: Alright. Thank you very much. 

Kelly Shea: Thank you. 

John Foster: I believe we have Steve Warshower followed by Diane Wilson. 

Steve Warshower: Good afternoon. I do not know how well I can follow a theater major. But, 

Handling Committee, my name is Steve Warshower. I am a farmer here in New Mexico 

and I also work with a number of farmers helping prepare their products for the supply 

chain and encouraging them to choose the organic label as a assure, an, an assurance of 

integrity and value to the consumers who will be choosing their products. I am also a 

member of the Cornucopia Institute and I am here today as a citizen lobbyist. In 1943, Sir 

Albert Howard, one of the founders of the organic movement wrote that the approach to

the problems of farming must be made from the field, not the laboratory. When soil 

fertility suffers, organic farmers turn to natural sources of nutrients rather than to

synthetic fertilizers. Should not the same principle apply to organic food? Chemical and 

pharmaceutical companies and their customers are now petitioning the NOSB to allow 

synthetic nutrients to be added directly to organic human foods. For every one of these 

synthetic nutrients there is an organic alternative, naturally nutrient-dense organic food. 

Just as synthetic fertilizers, which are synthetic soil nutrients, are prohibited in organic 

farming, synthetic nutrients should be prohibited from being added directly to organic 

foods. Synthetic choline and inositol are essen-, are not essential for organic handling 

since these nutrients occur naturally in food. There has never been a documented case of 

inositol deficiency since it is so common in everyday foods. Good sources of choline 

include peanuts, tofu, chicken, beef, eggs, broccoli, spinach, navy beans, fish, et cetera. 

In infant formula, organic soy lecithin would be a good source of choline. The technical 

review for synthetic choline points out concerns with the use of ethylene oxide and 
Meeting Of The National Organic Standards Board

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111

synthetic solvents, resulting in the possible presence of carcinogenic 1,4-dioxane and 

other toxic contaminants. The technical review, technical review also points out that 

people suffering from depression should avoid choline supplementation. Organic foods 

should be a healthy and safe option for all Americans including the 21 million suffering 

from depression. For infant formula, with the proposed NOP rule change clarifying the 

annotation for nutrient vitamins and minerals, any nutrients required by FDA would be 

permitted. Therefore there would, there would not be a need to add these nutrients to the, 

or vitamins to the National List. Please reject the inositol and choline petitions in their 

entirety. There is no need to allow these synthetic nutrients in organic food. Please also 

reject re-listing of carrageenan. It is clear from the preponderance of scientific studies 

conducted using food-grade carrageenan that it is not a safe ingredient for any food and 

we should be able to rely on organic food as a safe alternative to conventional foods. 

Thank you.

John Foster: Thank you. Nick.

Nick Maravell: See you were not a theater major, Steve. 

Steve Warshower: Working on it. 

Nick Maravell: You were obstructing your stage presence with your computer. I, I want to ask a 

question. I do not know if you can answer or have any knowledge of. I, I know that you 

are knowledgeable about cattle, but I do not know if you are knowledgeable about dairy. 

Is there any indication that the, your production system in dairy would change the levels

of inositol and choline in milk? 

Steve Warshower: I do not have any direct experience at a scale which would allow me to report 

on that from, you know, from data, but it stands to reason that it would.

Nick Maravell: And, and it stands to reason because? 

Steve Warshower: Well, the, the feed composition affects the product of, of a lactating mammal.

Nick Maravell: And what would be in the feed that, that might increase the inositol or choline 

levels in, in dairy cattle? 

Steve Warshower: Yeah, that one I could not answer.

Nick Maravell: Okay.

Steve Warshower: Have not addressed it at that level.

Nick Maravell: Okay. Thank you.

John Foster: Alright. Thank you very much. Next up Diane Wilson followed by John Ashby. 
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112

Diane Wilson: Good afternoon. My name is Diane Wilson. I am a registered dietitian and I am 

also the Nutrition Director for Nature’s One, the manufacturers of organic pediatric 

nutritional products. Thank you for this opportunity. I did have a formal presentation. I 

am going to go to the very end of it in the summary in the event that I run out of my three 

minutes. And basically, what we are asking the National Organic Standards Board and 

the NOP is to really take into consideration a group of, of medically challenged and 

medically vulnerable people who have not been addressed yet regarding the choline and 

the inositol issue. And this is a group of children, especially, from at least my 

perspective, where inositol and choline are absolutely essential. These are children who 

are enterally fed. And let me give you a definition of enteral as defined by both Medicaid 

and also by FDA in the Orphan Nutrition Act, I should say the Orphan Medical Act. But 

the Centers for Medicare and Medicaid Service recognize the importance of enteral 

nutrition products and have reviewed and approved our products, Nature’s One products, 

for use in eligible patients. They have assigned what is called a Healthcare Common 

Procedural Coding System Number, often referred to as a “hick-pick” [HCPC] number to 

be used by themselves and private insurance carriers for coverage of enteral nutrition 

products. Now, the, they define it as organic pediatric has been assigned the code, for 

example, our product PediaSmart as code B4160 specific for enteral formula for 

pediatrics. What this means is a child is unable to consume a normal diet of foods. The 

child must obtain their nutrition either orally from a liquid complete nutrition product or 

by tube. This tube would be inserted through the nose into the stomach or be placed into 

the stomach directly, a gastrostomy tube. These are children that absolutely require this 

nutrition. We are not talking about nice-to-have supplements, we are talking about 

complete nutrition that is often life-sustaining and often times needed for life. Okay. Let 

me also give you the definition by FDA. Under the FDA, Orphan Drug Act, Act, this is a 

food which is formulated to be consumed or administered enterally under the supervision 

of a physician and which is intended for the specific dietary management of a disease or 

condition. Again, we are not talking about a normal child or teenager who can eat foods 

and get these two nutrients. Now, I am running out of time, but what we are asking, is 

that you expand the definition of infant nutrition to include enteral nutrition products that 

medically... Thank you very much and I would be happy to address any issue pertaining 

to choline deficiency or organic inositol.

John Foster: Thank you. Question from Zea.

Zea Sonnabend: Do those children and their caregivers, or their caregivers, understand what 

“made with organic ingredients” means?

Diane Wilson: I am not sure I understand your question. I mean, the, we have... The people who 

are using our products are seeking organic products compared to the standard nonorganic that are on the market. 

Zea Sonnabend: So, we are proposing to allow these nutrients in the category “made with 

organic”, which would mean that it contains at least 70% of organic ingredients and 

could be higher, but then is also fortified with synthetic ingredients. 

Comment [JMS33]: 08:15:00
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Diane Wilson: Our consumers are hard-core organic consumers and they would appreciate 

having us listed as organic, over 95%. 

John Foster: Thank you. I wonder, I, I have a clarifying question. I could not do this and write at 

the same time. You said the, your preferred listing would be entero- and then I lost it.

Diane Wilson: It is called enteral medical nutritional products, e-n-t-e-r-a-l.

John Foster: Got it. Thank you. Jay.

Jay Feldman: Thank you and I want to thank you for your creativity in finding an alternative 

source of DHA that is ...

Diane Wilson: Thank you.

Jay Feldman: ... not synthetic. That is a testimony to the creativity and, I think, the future of 

organic. So in that respect, I, I wonder how deeply you have looked at the production of 

choline and the, I think one of our presenters earlier said, mentioned the 1,4-dioxane used 

in the production process, you know, to, to produce the choline and whether that, given 

your other efforts, would be of concern to you or were you aware of that or anything on 

that subject? 

Diane Wilson: Of course, we are aware of it. As you mentioned, we have taken great pains over 

the years to use a source of DHA and ARA that is not from algal and fungal sources. And 

we eventually, as of last year, we were able to introduce products with an egg

phospholipid organic compliant product. Regarding the choline, it would be wonderful if 

soy lecithin had adequate amounts of choline in it in order to support the needs of a child. 

We are certainly looking into options for organic choline. When organic choline and 

organic inositol are available, and we continue searching worldwide for such ingredients, 

you can bet your booty that we will certainly use it.

Jay Feldman: Thank you. 

John Foster: Alright. Thank you very much. 

Diane Wilson: Thank you.

John Foster: And thank you for bringing the “bet your booty” phrase back into style. 

Crowd: [Laughs]

John Foster: It was one of my favorites. So thank you. [Laugh] We have John Ashby up and 

following him is Bill Matakas.

John Ashby: Hi. I am John Ashby with California Natural Products. We have been, we have 

been making organic products actually since 1985. I just retired after serving several 
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114

years as the Chair of the State of California’s Organic Products Advisory Committee. I 

am currently the Chair of the Board of OMRI. I understand a little bit about volunteer 

work in a contentious situation and one of the things I want to do is reassure you that in 

my experience, no good deed ever goes unpunished. So just be prepared. But, in our 

family phrase, what we use is we talk about being a duck. And what being a duck means 

is the duck would freeze to death if the duck let the water get down to its skin but it does

not because he just lets it roll off. So just be a duck. I am getting a little more concerned 

about organics in general. I feel like we are moving beyond the circular firing squad into 

a game of Russian roulette with a six-gun with seven chambers full. There is, there is too 

much focus on too much negativity on too much trivial stuff. And I would like to see us 

think about this and I am just mentioning a few generic thoughts here about how we can 

approach things a little differently, have a few thoughts out in front of us. We need to be 

a lot more focused on what the values of organics are and a lot, worried a lot less about, 

about trivial little things. One thought that I do want to put in front of everybody here is 

you should always be thinking about avoiding policy or material decisions that are likely 

to conflict with FDA safety policies because if we fall into that trap, we are going to lose 

and FDA is going to win. That is not saying that you have to think “what would FDA

want me to do”, but be really careful about that. I am thinking about specifically about 

the vaccines for the salmonella. When, you know, they say, well we kind of recommend 

this as a procedure, they are saying a little bit more than, saying a little bit more than 

recommend. So, be careful about that. If we get too anxious about not allowing some 

nutrients into organic foods, we leave ourselves wide open to other people saying look 

they are not nutritious enough. Okay. I see in the comments, often, I see comments like, 

well there is a substitute, there is a substitute, there is a substitute. People who are saying 

that are usually not food product developers. I caution you to be careful with that 

statement. I have got decades, plural, of food product development behind me. Things are

a lot more complicated in the real world, real world than you think. The last comment I 

do want to make, is that be really, really, really cautious about ever eliminating anything 

off of the National List. And I want to remind us that we do have a 100% category for 

people that want this. We ought to be thinking not as the only driver of our thoughts, but 

we need to be thinking balancing this versus more agricultural land under organic 

management. 

John Foster: Thank you, John. Maybe I missed it but could you, I know your affiliation, but 

could you give your title and ...?

John Ashby: General Manager for California Natural Products. 

John Foster: Thanks. Thank you. Questions? 

John Ashby: Thank you.

John Foster: Alright, we are good. Thank you. We have Bill Ma-, Matakas – sorry for 

mispronouncing that. 

Bill Matakas: It is alright. It is Matakas.
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John Foster: Matakas. Thank you. And Jonathan Ashe deck.

Bill Matakas: So good afternoon. My name is Bill Matakas. I represent FMC Corporation. I am 

the Carrageenan Product Manager, so we obviously make the carrageenan. We support 

the continued listing of carrageenan as a allowed for use in organic non- synthetic. We 

also support the use of carrageenan in all applications. I was going to talk about, and I 

still will make comments on, the environmental nature and sustainability of seaweed 

farming but I do want to correct a, a comment I heard earlier. And the comment was 

based on the fact that the manufacturers have 25% low molecular weight product in there. 

The study that is out in the public on the website actually talks about five or six different 

ways that the industry and analytical chemists have tried to evaluate and measure low 

molecular weight carrageenan. That 25 percent was in one study and really showed the 

fact that that analytical method did not work, and it just crashed and burned. So it got a 

spurious result. I am not a analytical chemist, but I did read the study on the website 

while we were sitting here. And you can go to the Marinalg website if you want to read 

about that study. So I would really like to talk now about seaweed farming and its 

importance and also how seaweed goes from a sustainable farm product to a product that 

is used. Carrageenan is a safe product that not only is a good hydrocolloid but also helps 

the organic industry. I have one minute to talk about farming. Seaweed farming has 

happened since the 1970s. Sustain, it is sustainably grown on mo-, on family farms, small 

family farms in Southeast Asia and East Africa. FMC makes a priority of having people 

in the field to teach best farming practices, where to grow seaweed, how to grow 

seaweed, where not to put seaweed farms, how to harvest sustainable raw materials for 

the use in, in farming. On, also on the Marinalg website, there is a discussion paper on 

introducing species and control of that. That was discussed earlier about invasive species 

in a couple of areas that were done by people who did not do things properly. So the 

industry has taken a position and written a paper on that. You can look at that on the 

Marinalg website also. Finally, seaweed farms really help people who are at the fringes of 

the world economy. They are small family farms. They are people in East Africa, mostly 

women who have taken entrepreneurial spirit and, I have to stop. Do you have any 

questions?

Thank you. Jean, I think this is the speaker you have been waiting for. 

Jean Richardson: You are the speaker I have been waiting for.

Bill Matakas: Okay.

Jean Richardson: So I am one of those environmental types really struggling to understand the 

impact of seaweed harvesting on the marine ecosystems. 

Bill Matakas: Sure.

Jean Richardson: So what I am looking for is some understanding of the percentage of 

carrageenan that is today sourced from wild as opposed to farmed and for you to see if 
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116

you can provide me with some of the cons-, the data which would suggest that there is 

still wild a lot of wild carrageenan harvesting taking place which is having a negative

impact both on coral reefs and also on the, the over harvest, excessive over-harvesting 

such as off the coast, coast of Nova Scotia. 

Bill Matakas: The, the, so there is two types of seaweed. There is the wild harvest seaweed that 

primarily occurs in cold waters. So the coral reefs do not come into play with those. 

Where coral reefs are, and, and let me give you an analogy. If you look at the three 

largest countries that provide seaweed to the industry, Indonesia, Philippines, and, and 

Tanzania. If you took a look at the total area of their coral reefs and you equated that to a 

football field and you said, if you were to put all of the seaweed farms over top of that 

football field, how much area would that take up? You would put the football on the one 

foot line and basically have that little strip. It is about three tenths of a percent. Most

seaweed farming is actually done on a floating line system, where seaweed is tied to a 

nylon rope. And they really recycle most of the drink bottles and use those as floating 

devices. And so then they are, then that material is brought in by these family farmers and

then sold through co-ops in these villages to people who then sell it into the processing 

industry. The over-harvesting, there are normally management plans, I think Canada has 

a management plan and most of the cold water countries have management plans to 

manage their own marine environments. 

Jean Richardson: May I have a follow-up question? What about the, the seaweed harvesting in 

the areas which are basically, need, need the, those species to protect the coral reefs? 

Bill Matakas: The, the seaweed is done floating above the coral reefs so it is done in pretty deep 

water when I have been out there on the, their little plywood boats the, the seaweed 

farmers tend to use. So they are not touching the coral to destroy it. The coral destruction 

primarily happens due to dynamite fishing in these regions, where people either are 

fishing to for sustainability of food or the tropical fish trade can happen. So they, they

throw dynamite in and then that destroys the coral. There was a good article on a marine 

park at Indonesia that was a protected area and the coral has been completely destroyed 

by dynamite fishermen. 

Jean Richardson: Did you give a percentage of how much of the sea-, carrageenan is coming 

from wild as opposed to [inaudible] farmed? 

Bill Matakas: Wild harvest is probably about 20 percent of the total seaweed harvested for the 

carrageenan industry. It is a pretty small amount. 

John Foster: Great. Thank you very much. 

Bill Matakas: Okay.

John Foster: We have Jonathan Ashe and then Charlotte Vallaeys is up on deck. 

Comment [JMS34]: 08:30:00
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117

Jonathan Ashe: Hello. My name is Jonathan Ashe and I am owner and farmer of Thunderhead 

Farms in Bosque Farms, New Mexico. I am also a conscientious consumer seeking the 

best quality foods when I am unable to produce them myself. To me, that means the 

organic label. It also means I put my trust in you, the NOSB, to maintain the integrity of 

that label. I am also a Cornucopia Institute member and here today as a citizen lobbyist.

Cornucopia supports the re-listing of agar agar as a non-synthetic with the annotation of 

“from Gelidium species only, processed without alkaline treatment.” According to the 

technical review, two different species of red seaweed are generally used to produce agar 

agar: Gelidium and Gracilaria. Gelidium was the original species to use to make agar 

agar. Gracilaria is only suitable as an alternative to Gelidium if it is treated with alkali, 

which cause a chemical change that leads to increased gel strength. The technical review 

misleadingly states that Gracilaria species are usually, usually subjected to alkali pretreatment, when in fact, commercially viable agar agar from Gracilaria must be treated 

with alkali before extraction. This is an important distinction which bears repeating 

because it is crucial to understand the reason for our proposed annotation. Agar agar from 

Gelidium is not treated with alkali and therefore does not undergo chemical change while 

agar agar from Gracilaria requires alkaline pre-treatment and the chemical change to be 

useful for commercial applications. We therefore urge the NOSB to adopt the following 

annotation for agar agar: “from Gelidium species only, processed without alkaline 

treatment.” Next I will briefly address the Sunset material cellulose. Cornucopia cannot 

support the re-listing of cellulose without a new TR that bridges the eleven-year gap from 

2001 when a, the TR was performed, until today. The original TR found microcrystalline 

cellulose to be highly processed material, and not compatible with organic handling 

systems. And reviewers unanimously suggest that microcrystalline cellulose be 

prohibited in organic foods. The 2001 TR pointed out environmental concerns with the 

production of microcrystalline cellulose as well, quote, acid waste due to the hydro-, 

hydrochloric and other acids. For cellulose, please add the annotation. From DHA to 

carrageenan, it is true that we cannot always rely on the work of past reviews. Please 

request a new technical review for every Sunset material. Thank you. 

John Foster: Thank you. Question? Alright. Thank you very much.

Jonathan Ashe: Thank you. 

John Foster: Next up, we have Charlotte Vallaeys and last commenter will be Kim Dietz after 

this. 

Charlotte Vallaeys: Thank you. My name is Charlotte Vallaeys. I am Director of Farm and Food 

Policy at the Cornucopia Institute. Thank you, Board members. Welcome to the new

Board members. Thanks for your hard work on these very important issues. The 

Cornucopia Institute has approximately 7500 members, with certified organic farmers as 

our primary constituency. We feel very fortunate that a number of our members including 

organic farmers living in or near Albuquerque were able to be at this meeting to present 

testimony. I would like to speak about carrageenan. I wish I also had time to comment on 

inositol and choline, agar agar but I will focus my three minutes on carrageenan. The 

human health concerns in foods from car-, from carrageenan are so serious, according to 
Meeting Of The National Organic Standards Board

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the preponderance of scientific evidence, that I urge you to make your decision based on 

the law, and on the scientific evidence presented to you in written and oral testimony. 

The law states that the National List may provide for the use of substances in an organic

handling operation that are otherwise prohibited only if the use of such substance, 

substances would not be harmful to human health. The International Agency for Research 

on Cancer has classified degraded or low molecular weight carrageenan a List 2B, as a 

possible human carcinogen based on the fact that it is a carcinogen in animal studies. The 

European Union determined in 2003 that no more than 5 percent of food grade 

carrageenan should contain the low molecular weight, less than 50,000 daltons. The 

industry then tested their own product, products to determine if they could meet that 

standard. They found that first of all, and I have copies, which the previous presenter 

mentioned as well, I have copies of the study he mentioned for, for everybody. They 

found first of all that they were not able to reliably test. Second, they found levels ranging 

from a very low percentage, but ranging all the way up to 25%. I repeat, the industry's

own data show that degraded carrageenan, a classified possible human carcinogen was 

found in every sample that they tested. We are also very grateful that Doctor Tobacman 

travelled here at our invitation, but at her own personal expense to present her research to 

you. As the leading physician scientist who has devoted the last two decades of her 

professional career to studying the effects of food grade carrageenan, we urge you to 

consider her testimony and expertise when you make your decision as to whether 

carrageenan, any carrageenan, fits the law’s criteria and is safe for human health. And I 

will end right there. 

John Foster: Thank you. Do we have a question? Nick.

Nick Maravell: And, John, I may very likely have one follow-up question as well.

John Foster: Thanks for the heads up.

Nick Maravell: Charlotte, what, in your opinion, based on your investigation, what information 

would satisfy you that carrageenan was indeed safe to use and, and I will just make up an 

example. If independent studies showed that the use of, of food grade carrageenan was 

essentially of the high molecular weight, a very low percentage of the low molecular 

weight carrageenan – I am just making that as an example; I am not trying to put that into 

your lexicon – but I am just saying, could you, could you give us an example of what 

information you think that we should have available to us before we would allow 

carrageenan on the National, continue to be on the National List? 

Charlotte Vallaeys: Right, well I personally, I, I buy organic food because I am looking for a safe 

alternative. I, I, I also really believe in the precautionary principle and I would... When I

look at the science, even if the science is mixed, so Doctor Tobacman’s research,

independently funded, shows she has determined the pathways by which this causes 

inflammation so you have that, that research. If there is research showing that, coming to 

conclusion that there are no human health impacts, that, that is a mixed research and I 

would hope that the precautionary principle would be guiding the decision in determining 
Meeting Of The National Organic Standards Board

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whether something would be safe in, in organic, in food, and all food. Does that answer 

your question? 

Nick Maravell: Well, yes. Let me follow-up with the, the precautionary principle, which is

something that is, is more predominant in Europe, than in the United States with regard to 

how we evaluate environmental and food safety issues. What is the status of carrageenan 

in, in Europe and I know we have, we have heard some of the European studies and, and

limitations on infant formula, etc.? What is the general condition of the allowance of, of

carrageenan in, in Europe where there is more acceptance, I do not know total 

acceptance, but more acceptance of the precautionary principle? 

Charlotte Vallaeys: I, I do not know the current status. All I know is that when the European 

Commission’s Scientific Committee on Food reviewed the scientific data on carrageenan, 

that they did say no more than 5% of degraded, less than 50,000 daltons molecular 

weight carrageenan in the food and that is what prompted this industry testing of which I 

have copies of in which the, they were trying to figure out if they could meet that 

standard and, and that is where they found that they were not even able to really reliably 

measure. So, I, I, but I do not know where they are right now in the European Union.

John Foster: Thank you. Okay. Did you want to [inaudible]?

Nick Maravell: But if we, if that standard were met, would that satisfy the concerns of 

Cornucopia here in the United States? 

Charlotte Vallaeys: Oh, no, I mean I, I believe in the Delaney Clause. Zero percent carcinogens 

should be the acceptable limit in our food. I, I do not think 5 percent When you are 

talking about a possible human carcinogen, I do not think 5 percent is, is an adequate lim, 

limit. I think it, it should be zero percent. 

John Foster: Thank you. Mac.

Mac Stone: As an organic food buyer, what foods do you wish you could buy organically that

have carrageenan in them and you cannot buy or you choose not to? 

Charlotte Vallaeys: It is interesting that you should ask that. I actually have to avoid carrageenan 

in my diet. I am, I am one of those people who unfortunately experiences very serious 

gastrointestinal symptoms to carrageenan and it took me years to figure it out. And, and I 

am actually grateful for the organic program because it is, it is only now that I have really 

been able to confirm that it is carrageenan that has caused these symptoms. So, yes, I 

have been avoiding carrageenan. And, and it, it appears that from previous comments, 

that ultra-pasteurized whipping cream, chocolate milk, are, are some foods but again, it is 

not just me, because I actually experience the symptoms, I am aware of them very much 

but also, for my children, if I had to choose between a chocolate milk that I had to shake 

in order to get the cocoa particles to be evenly distributed again or, or knowing that I was 

giving them something that has perfect texture and good mouth feel but was causing them
Meeting Of The National Organic Standards Board

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potential harm, I, I personally would I mean obviously choose the kind without the 

carrageenan. 

Mac Stone: Thank you.

John Foster: Colehour.

Colehour Bondera: Yes, thank you and thank you for your testimony, Charlotte. You just said 

something that I, I am not quite sure, I made myself some notes and I am not quite sure I 

have this straight, but that whole, like it is not health, the dietary issue of reacting, and 

adverse reactions, and I am just wondering through what sounded like you have done at 

the beginning, you, you made it sound like you have researched this and I am just 

wondering if there are outside of your own personal experience, if you have documented 

cases of adverse reactions to carrageenan that it sounds like you, you made it sound like 

you are an example in experience but, can you take that any further in terms of, you 

know, is there science, literature and cases a-, around that? 

Charlotte Vallaeys: Yes, well interestingly, there was one comment, written comment, which is 

from another individual who also, like me and many others, exp-, actually notices the 

gastrointestinal inflammation from eating carrageenan and, and he made it sound as if he 

was a unique individual and in experiencing those symptoms. And he actually cited a 

study and I went and I looked up that study and it was a 26-year-old woman and – this is 

in a peer-reviewed published journal – I actually do not remember the exact journal name 

– but it was the case of a 26-year-old woman who experienced serious gastrointestinal 

symptoms that led to invasive procedures. And, and the study noted that her symptoms 

went away after she eliminated carrageenan from her diet. So there is a document, I 

mean, that is a documented case but, you know, I will document my case right here. I will 

say it on the record. And I, I am also very aware of online forums. If you Google 

carrageenan and gastroin-, gastrointestinal symptoms, you will find many online forums 

of people who have noticed that if they remove carrageenan from their diets, symptoms

that sometimes they have been living with for years, disappear. So ...

John Foster: Thank you. We have one more question. Tracy.

Tracy Favre: Would you advocate removing products from the marketplace that provoke 

inflammatory response in other types of foods and other types of ingredients?

Charlotte Vallaeys: I, I think that with carrageenan, the inflammation, some people notice it. I 

do. I asked Doctor Tobacman, you know, why, why do I experience it and, and not others 

and she has an explanation for that. But what she has shown in her research is that 

everybody experiences the inflammation. It is just a matter of whether you are aware of it 

and it has to do with maybe the gut flora, but that, so her research has shown that it, it

does cause the inflammation. You may just not know about it and therefore, it is, it is

different from being an allergic reaction. Because I understand the argument, well we are 

not removing organic peanuts from the marketplace because some people are allergic to 

peanuts. I think this is a very different, a different situation. 

Comment [JMS35]: 08:45:00
Meeting Of The National Organic Standards Board

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121

John Foster: Alright. Zea, drop dead last question. 

Zea Sonnabend: Thank you. You and your team of lobbyists keep referring to a preponderance of 

data. The three reviews that I cited had 157 citations by 100 different authors 

approximately of which you cited some of the same ones in yours, about maybe 20 and 

selected different parts of them to put in your review, but I, with about 40 citations. I just 

do not see how you can say a preponderance of data when the vast majority of those 

studies in the reviews I cited had opinions that disagreed with your opinion. What is your 

response to that? 

Charlotte Vallaeys: Yes, well I think it is interesting to look at who fund, who funded those 

review studies. 

Zea Sonnabend: A hundred of them? 

Charlotte Vallaeys: The review studies.

Zea Sonnabend: But they cited other studies. That, those are the citations I am referring to.

Charlotte Vallaeys: Right, so I, I mean I can give you one example. When the Marinalg Working 

Group put their findings, their position paper on the safety of carrageenan on their

website, for example, they cited a study which was their way of saying look, the, it is 

safe. And they cited the study. When you actually went to the study, they did find higher 

rates of cancer. They just had a different conclusion. If you, so there are different ways 

of, of taking the data and, and I am sorry to say, but sometimes twisting it. And that is 

why I do think it is important to look at who cites, who funds the studies that you are 

looking at and also to look at, at, well I will end it right there. 

Zea Sonnabend: Thank you. 

John Foster: Thanks. That is it. Thank you. Last speaker, Kim Dietz. 

Kim Dietz: Last but not least. I am the least. I think I am the last of the whole session, right?

Okay. Good afternoon. My name is Kim Dietz and I served on the NOSB from 2000 to 

2005 as handler representative. I am the founder and co-chair of Materials Working 

Group. My employer is James Smucker Company and I have worked for them for 28 

years. I have been an active stakeholder in this industry for about 25 of those. Today I am 

here to provide comments, personally, as a materials expert and secondly, on behalf of 

my employer. Smuckers would like to support the continued use of cellulose and 

carrageenan. I was on the NOSB when of cellulose was reviewed and agree with the 

Program's interpretation that the intent was for powdered cellulose. Therefore I support 

an annotation change for the powdered form for use as a filtering aid. Excuse my laptop 

but I did not plan on giving public comment. But I felt that was necessary today. 

Carrageenan: Smuckers uses carrageenan in a blend, a blend of four gums. One gum is 

organic and the other three are on the National List. Carrageenan provides a specific 
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functional effect and there are no organic or conventional alternatives. The percentage of 

gums including carrageenan in our finished product is 0.073. Yes, it is labeled on the 

product. The criteria for removal of a su-, of a material during Sunset is that it must be 

demonstrated that a substance is harmful to health. I am not convinced that approximately 

0.0025 percent of carrageenan in a bottle of organic juice is harmful to health. Most 

likely, we would not be able to purchase that blend of gums without carrageenan. As 

Board members, it is your job to use the facts presented to you. At the end of the day, if 

there is not absolute evidence that you should dis-, that you should not disrupt this 

industry and remove a material during the Sunset process. Personal comment: Lastly, I 

want to remind this Board and the public that, as consumers, we have a choice in 

purchasing organic products. We have three labels, 100% organic, organic, and made 

with. If the consumer wants to purchase products without any substances on the National 

List, then they should purchase the 100% organic label. If you would like to ask me about 

my role with the Materials Working Group, I would be happy to answer that. 

John Foster: Thank you. Nick, Jay and then Joe.

Nick Maravell: Do you have any products under the 100% label, that you market under the 100% 

label? 

Kim Dietz: We had two products, 100% lemon and lime but with the processing aid change, we 

took those off. We, no, we do not. It is, it is pretty much impossible. 

John Foster: Jay.

Jay Feldman: Thanks, Kim, for testifying. I know you did not have stage fright. 

Kim Dietz: I know, well I do, actually. I hate to do this but that is okay. 

Jay Feldman: Well, thank you. I, I am struggling with a couple of things. One thing I am 

struggling with is, eating ice cream one day, I looked at the container after having read all 

the great work of the Handling Committee, and I noticed that my favorite ice cream had 

carrageenan in it. And then I went to one of my favorite grocery stores and I looked in the 

fresh, in the freezer and I picked out another one of my favorite ice creams and it did not 

have any carrageenan. So I said to myself, is this necessary? And then I had the 

opportunity to read the public statements and a couple of companies indicated the

necessity, the essentiality of this material in certain products. And I am trying to still get a 

handle on what those are because certainly I do not, I, I hope everyone in this room 

would agree that we can take the non-essential stuff off the table right at the get-go. And 

then we move to how we move away from something that has uncertainty. I may differ 

with you here, and I, this is where I wanted to see if we could get your help. Both on the 

issue of, you know, uncertainty when there is uncertain science, is organic not a place 

where people can go until certainty is found? Certainty on the side of safety and health, is 

that not a valid, given that you were on the Board, and is that not a valid position to take 

on this Board? And can we come up with a list of where, you know, there really are no 
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other alternatives to this, to this material? And then tell us about the Materials Working 

Group. 

Kim Dietz: Okay, thank you. Well, first of all, when you review materials, you know, you have 

to go through the list of all of the different criteria. And it is not that you must meet one 

or two or three, you have to look at all the criteria in a whole and decide whether or not 

that is something that is the best choice. So you have to make that choice. That is how I 

did it as a Board member. The essentiality of it, Jay, you know, yes, you, you could 

probably make ice cream – we do not make ice cream – but for us, for juice, if we did not

have that specific gum in our products, they would totally separate and float. And it, it is, 

just the consumer would not buy it and at least that is my opinion, and we would 

probably most likely not market that juice. So that, that is my response to that. Material, 

was there another question or you want me to ...? 

John Foster: Continue. Continue.

Kim Dietz: Oh, okay. So the Material Working Group: I know that there was some discussion 

about what our specific role was with the NOSB, so I want to just provide you with that. 

We, I founded the Materials Working Group after my role on the Board, so that the 

history of materials would not be lost, so that we could give, provide to you, as current

Board members, the history of how things, how things were reviewed and so that we had 

consistency, year to year to year to year. So we were not a formal NOSB task force. What 

we were was a separate group, independent, anybody could join as Zea had said and we 

were given special time on the agenda as presenters. So you have a policy in your 

handbook, I believe it is still there, that, where you could invite presenters. So we were 

invited as presenters during the materials review process and we gave you our technical 

information. We would be happy to serve in any function, whatever you see fit. Thank 

you.

John Foster: Thank you. I had Joe next. I actually had Joe next in line.

Joe Dickson: Going back to cellulose, you said you would support an annotation restricting it to 

the powdered form?

Kim Dietz: Yeah, I kind of, kind of took what you had, but yeah I think we, I would definitely 

support it. That was the intent when I was on the Board and I also downloaded our spec 

sheet this morning just to try to make sure that I could craft something correctly. I think 

really all you need to do is add the word powered right before non-chlorine bleached and 

as a filtering agent and that would work. 

Joe Dickson: So, if it read, and let me try like this on here, if it said cellulose for use in 

regenerative casings, powdered cellulose as an anti-caking agent non-chlorine bleached et 

cetera?

Kim Dietz: Well we, we actually use cellulose as a filtering aid so ...
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124

Joe Dickson: Right.

Kim Dietz: ... yeah, 

Joe Dickson: Well, yeah, that is ...

Kim Dietz: ... either, either, yeah, so if it was before, it would be fine. 

Joe Dickson: Okay. Thank you. 

John Foster: And, Zea, I saw your hand up at the last minute. Did you get what you needed? 

Kim Dietz: Okay. Good luck, thank you.

Crowd: [Laughs]

John Foster: Thank you. [Laughs] Thank you. Do not quite know how to take that. So, we are 

considerably behind schedule. Barry and I conferred and we are going to try and get a 

few of the Handling materials through the next step, recognizing they are not all going to 

get done. He and I kind of took a barometer and we feel like the Board has probably got a 

half an hour left in it, gas in the tank, today and so we are going to try to get done what 

we can in the next half hour. Be, because of that, I do not think, we are not going to be 

able to cover the materials in sequence. My suggestion, Barry concurred, was to try and 

move through, huh-huh-huh, hopefully the less contentious things today, right now, see 

what we can get through and the rest will, of course, be need to be moved to tomorrow. 

So, Miles, your question earlier of what we are going to do tomorrow, I, I think we have 

it figured out now.

So, my, my suggestion is that we try and get curry leaf and citrus hystrix worked on right 

now. They seem to be less contentious, anyway I can only hope and we will get as far as 

we can on those. Now, this is the part where we are moving into a new, a new kind of a 

phase in the, in the format where it comes to, that I am going to need help with. And, and

actually, this is why I wanted a break before this too but we will do the best we can. I 

need help knowing now if, how, what the process needs to be. Is Barry going to call on 

me to present materials or do I do that myself? And I do not think we worked that out 

ahead of time. 

Barry Flamm: You want to go directly to motions on these, on, on the ones that are easy? And 

then have discussion afterwards?

John Foster: We can, we can. Yeah. Okay. Program okay with that? Oh, okay. 

Barry Flamm: So you, you need to tell me which, which are the easy ones you want. 

John Foster: Well, I thought we would, curry leaf first. Cur, curry leaf first and then citrus 

hystrix.
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Barry Flamm: Okay. Do we, do we have a motion on, on curry leaf? 

John Foster: Yes we do. Let me find it. We, we would be making two motions here and actually 

there, there needs to be a correction on here that the motion to determine the substance is 

agricultural. This was an error that we had. So the first motion, the, I, I would move that 

we determine curry leaf as petitioned to be agricultural. Is there a second? 

Tracy Favre: I will second.

Barry Flamm: Is there a second to the motion?

Barry Flamm: Tracy seconds.

John Foster: And Tracy seconded. Discussion?

Barry Flamm: Discussion on the motion to, to consider curry leaf an agricultural product. There 

being no, no questions, no discussion, we will begin the, the voting. 

Zea Sonnabend: Conflict of interest. 

Barry Flamm: Conflict of interest. Thank you. My note, right in front of my nose but... Anybody 

have a con- ... I would like to just, can, is it possible to group these? Or do you think 

each one has an individual potential conflict of interest? I do not want to take too much 

time. I, I will just proceed with this one and ... Conflict of interest, Zea? 

Zea Sonnabend: I work for a certifier which has growers who grow this product as well as every 

other product, or have, use it as an ingredient in every other product in the Handling

Committee agenda today.

Barry Flamm: Okay. So you are either [inaudible]...

Zea Sonnabend: Should I recuse myself? I do not feel the need to recuse myself. 

Barry Flamm: I am sorry?

Zea Sonnabend: I do not feel the need to recuse myself but Miles has to say. 

Miles McEvoy: No, you do not need to recuse yourself. 

Zea Sonnabend: Thank you. 

Barry Flamm: Alright. Anybody else have a con-, concern over conflict of interest? I will look 

down. Jennifer, I do not want to forget you.

Unknown Male: He cannot see you.

Comment [JMS36]: 09:00:00
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Jennifer Taylor: I beg your pardon? No. I am, I am fine.

Barry Flamm: Do you have a conflict of interest? 

Jennifer Taylor: Oh, no.

Barry Flamm: Okay, we will proceed with the, with the voting with Jean.

Jean Richardson: Yes. 

The Entire NOSB Board: Yes. Yes, sir. Yes. Yes. Yes. 

Jennifer Taylor: It is me? Oh. I am already on. No.

Barry Flamm: Remember the, the motion is on whether this is an agriculture, this is agriculture 

or not agriculture.

Jennifer Taylor: Oh, okay.

Barry Flamm: So you, you voted that it is not agriculture.

Jennifer Taylor: Oh, okay.

Unknown Male: [Inaudible]

Jennifer Taylor: I will change my vote to yes, please.

Barry Flamm: Jay.

Jay Feldman: Yes. 

The Entire NOSB Board: Yes. Yes. Yes. Yes. Yes. Yes. 

Barry Flamm: Oh, you already voted, did not you? And me, yes. Chair votes, yes. 

Unknown Female: Okay.

Barry Flamm: Lost track of vote. Okay, do we, do we have a motion on, on listing? 

John Foster: Yes, we have a listing motion. I move that to add Murraya koenigii, parenthetically 

curry leaves, to section 205.606 not organically produced agricultural products allowed 

as ingredients in or on processed product labeled as organic.

Barry Flamm: Very good, John. Do we have a second? 
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Unknown Male: I will second. 

Barry Flamm: We have a, a motion and it has been seconded to list curry leaf, and I will not even 

try to say what John said. I will ask again is there conflict of interest? But have we 

cleared ...

Zea Sonnabend: Should I repeat mine for each vote we take?

Miles McEvoy: You do not need to do that again for the same substance.

Zea Sonnabend: Okay.

Barry Flamm: Okay. That is what I was hoping the answer was. Any, any other conflict of 

interest? Hearing none, start with Harold.

Harold Austin: Yes. 

The Entire NOSB Board: Yes, sir. Yes. No. Yes. No. Yes. Abstain. Yes. Yes. Yes. Yes. Yes. 

Yes. Yes. 

Barry Flamm: And the Chair votes yes. Let us see the count. 

Unknown Female: Two no, one abstain.

Unknown Males: Yeah. Yeah. Twelve yeses. Twelve yeses. Twelve yes, two no. 

Barry Flamm: The motion carries. I want to make sure of the vote count. What is it again? 

Unknown Male: 12, and 2, and 1.

Barry Flamm: Twelve yeses; two noes; one abstention. It was, John, which is the next one you 

want to bring up?

John Foster: Next one would be on the petition for citrus hystrix leaves and fruit. 

Barry Flamm: You want to make a motion? 

John Foster: Do as a classification motion. I move to determine the substance is agricultural. 

Barry Flamm: Do we have a second? 

Jean Richardson: I second. 

Barry Flamm: Jean seconds. We have the, the motion and the motion has been seconded to, to 

classify citrus hystrix as a, as agriculture product. Any discussion? Okay. We will begin, 

begin the voting. 
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Zea Sonnabend: Conflict of interest again. Do we, did it cover it for every item or do I have to 

repeat it again? 

Unknown Persons: No. No. You are already covered. No.

Zea Sonnabend: Yes?

Barry Flamm: We are not going to repeat for you again. 

Zea Sonnabend: You have to have the requirement, though.

Barry Flamm: You are covered. But does anybody else have a conflict of interest? 

Miles McEvoy: You, you are doing it for each substance, so you are doing it each time, so you

disclose that you have the conflict? 

Zea Sonnabend: Every single time.

Miles McEvoy: Or you have to, [inaudible] 

Zea Sonnabend: I cannot do it once for all the handling Committee items on our agenda that I ...

Miles McEvoy: So for every single one.

Barry Flamm: Yeah, I thought we...

Miles McEvoy: Yeah, you can disclosure interest and it is the same interest, correct? So you do 

not need to recuse yourself. 

Zea Sonnabend: Thank you.

Barry Flamm: So you are clear. And that was my understanding before, that that was your 

decision. But, but that does not apply to the others. So I should ask the question. Hearing 

none, I think we can proceed with voting. 

The Entire NOSB Board: Yes, sir. Yes. Yes. Yes. 

Unknown Male: This is to classify.

Jennifer Taylor: Yes. 

The Entire NOSB Board: Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. 

Barry Flamm: Yes. 
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Unknown Male: Fifteen-oh.

Barry Flamm: Fifteen yes. Zero no. The motion passes. What is the next, John? Oh, no, we are 

still on this one.

Unknown Male: We need a listing...

Barry Flamm: We need a motion now to list. 

John Foster: So I will move to add citrus hystrix leaves and fruit to section 205.606 not 

organically produced agricultural products allowed as ingredients in or on processed 

products labeled as organic. 

Barry Flamm: Do we have a second? 

Harold Austin: Second.

Unknown Male: Second.

Barry Flamm: Harold second. And we, we have a motion and it has been seconded to list citrus

hystrix on the, on the List. Okay. This is somewhat redundant to ask on the same product 

twice, but I will ask if there is any conflict again. 

Zea Sonnabend: I think Miles said you only have to do it once per product. 

Barry Flamm: Yeah, I would think so. I will not do it again on the next one.

Unknown Male: [Inaudible]

Barry Flamm: Okay. I think, is there any discussion? Any discuss, any discussion on the motion? 

Hearing, hearing none, we will move to the vote beginning with Wendy. 

Wendy Fulwider: Yes. 

The Entire NOSB Board: No. Yes. No. Yes. Abstain. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes,

sir. 

Barry Flamm: Yes. Have, I believe...

Unknown Male: 12, 2 and 1 abstention.

Barry Flamm: Twelve, 12 yes; two noes; one abstained, one abstention. The motion passes. What 

next, John? 

John Foster: Alright, I think we probably have room for a couple more. We are going, we are 

going to move to Sunset item calcium sulfate. Joe?
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Joe Dickson: I move to accept the Sunset recommendation to re-list calcium sulfite, sulfate 

rather, mined on 205.605(a) non-synthetics allowed. Is there a second? 

Jean Richardson: Second. 

Unknown Female: That was Jean.

Barry Flamm: Motion, let us see, are we, no, we do not have to do the classification on that. That 

is right. We have a motion to re-list calcium sulfate? The motion has been seconded. Is 

there discussion? 

Unknown Male: Jay.

Jay Feldman: I would like to move to amend the motion to include an annotation that says for 

use only as a coagulant in bean curd in parentheses tofu and similar products.

Barry Flamm: You are proposing an amendment to the motion?

Jay Feldman: Yes. I would need a second, I think.

Barry Flamm: Yeah, you will need a second. 

Colehour Bondera: I will second that. 

Barry Flamm: So we will have discussion on this amendment and the vote on it separate from 

the, from the, the main motion. We will, we will take care of that first. Discussion on the

amend, amendment which, which has been seconded? Yes.

Joe Dickson: [Inaudible] On the proposed amendment, I just want to argue against it because the 

...

Barry Flamm: Okay. No, I was going to open it for the discussion right now. Go ahead. 

Joe Dickson: I am, I am okay to discuss the amendment right now. Okay, good. Just figuring this 

out. The version of the Sunset proposal that was posted did not include that annotation 

language and my fear is that there are beer brewers in particular and potentially other 

stakeholders who are using the ingredient and do not know that it is about to no longer be 

available to them if this annotation passes. So for that reason, and that group of 

stakeholders, I would not support that amendment. 

Zea Sonnabend: [Inaudible]

Barry Flamm: Zea, please.
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Zea Sonnabend: Thank you. I would like to ask Jay why, like you think it will be abused in 

some way if it is allowed for everything?

Jay Feldman: [Sigh] Well, we, we, I thought we had an understanding that we knew the uses but 

this is a process issue for me. I think we do need to know uses to make a judgment on 

essentiality and I would hate to be in the situation, Joe, every time that we are evaluating 

these things where we have not involved the whole community of users on these things. 

We, we need to have a process that brings everybody in and they know that the material 

they depend on is being discussed and, and should be aware of our process enough to 

know that anything can happen at these meetings so, unfortunately. And that is, by the 

way, that is my plug for the communications policy. 

Zea Sonnabend: But is there something that leads you to believe that there is concern in some 

uses and not others? That you would like arbitrarily pick some uses when you do not

know all the uses?

Jay Feldman: Well, I, no. I mean, I ex-, we ex-, in this whole system, there, there were uses that, 

you know, in terms of skin irritation and I mean there are issues we could run through all 

the hazard issues and then there are questions of alternative management strategies or 

alternative materials that can be used as a coagulant for other products. So the whole goal 

of this program I think is to reduce to the extent possible, reliance on these things and

identify where the uses are truly necessary or truly needed and then, you know, ratchet it 

down to the extent possible. So yeah, I mean, when I looked at this, it seemed pretty 

convincing to me that there are other, other uses, other coagulants that could be used in 

this situation. And so the one that rose to the top is the one that was both most widely 

used and most necessary. But I would turn that around to the com-, was this use that is 

being defined is tofu, but what I would do is turn around to the Committee and tell me 

what you found relative to the use and why we need to leave this open ended and not 

evaluate each of the uses that, for which this is being used. That, that is my question. I, 

you know, I am not saying you should take me at my word on, you know, on this 

particular use but this is what I proposed, you know, was proposed by Beyond Pesticides 

early on in the process, it went to the Committee, the Committee had it, we had an 

opportunity to discuss whether this issue of necessity was, was not, you know, was a 

bogus issue or not and then my hope was that we would have had that discussion and 

then we would come to this meeting and everybody would have been able to, to make a 

decision based on the criteria that, that we are supposed to be evaluating. So, again, I, I

view this as somewhat of a process issue but yeah I am concerned that when we have 

these open-ended use, uses, that stuff happens, use happens, and expansion and goes on. 

Barry Flamm: Nick? 

Nick Maravell: Yes, Jay, I think you raise an important question. It, it is a broad, much broader 

question than this material. And I can also say that I do not think that there is a broad 

consensus that, you know, we are trying to move in a direction that would reduce reliance 

on materials on the National List. If that were true, I think we would see the National List

Comment [JMS37]: 09:15:00
Meeting Of The National Organic Standards Board

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getting shorter and shorter. So, you know, I do not think, I think it is a good discussion to 

have, but I am not sure we, if, if this is the appropriate place and time to have it. 

Barry Flamm: John, you want ...

John Foster: I think this is, I think this is one place where if we, if we had an unlimited time to 

work on things, we could have gotten to this, but I think for all the right reasons, it was 

not at the top of the priority list for the Handling Committee to try and deal with. There 

were other things that the public certainly felt were a higher priority. And, I mean, I hate 

to say that we, we do not have the time to deal with this, with, with everything but the 

truth of the matter is, we do not. None of the Committees do. So I think it, if anything, it 

was a little more priorities and I do not want to speak for the rest of the Handling

Committee but I think we prioritized the best we could.

Unknown Male: [Inaudible] table coagulants was presented in the testimony [inaudible]

Barry Flamm: Zea and then I will since I will give the proposer of the movement, motion the last 

word and then will, I will call for a, and we will have a vote. 

Zea Sonnabend: I just want to say that while I somewhat agree with you on synthetics in

processing, this is a non-synthetics in processing and everything in the Rule does not lead 

us to a great deal of concern about non-synthetics in processing. 

Jay Feldman: [Sigh] I just, I just hope ...

Barry Flamm: Last word.

Jay Feldman: In, in the spirit of what you said, Nick, I, I really hope we can get a process that 

enables us to say to our community, we have evaluated these things, the uses, and we 

made a determination that these things are acceptable. I, I also do not like blind siding 

users of materials that people have come to depend on and in that spirit, I will vote for the 

motion but I, I really think we need a process that clearly evaluates these things, on use 

basis-es. That is only basis on which we can make a determination. 

Unknown Male: Thank you.

Barry Flamm: Did I, I am sorry, Jay, did you make ...

Jay Feldman: I withdraw my motion if Colehour agrees to that. 

Colehour Bondera: I agree. 

Barry Flamm: Okay, I guess we are... Are we ready to vote on the ...? We have a, a motion that 

has been seconded to, to list calcium sulfate. Is there any further, is there discussion on 
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133

the motion on the, on the floor? Question on the floor? Hearing none, we will begin the 

vote with, with Colehour. 

Colehour Bondera: Yes. 

The Entire NOSB Board: Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. 

Barry Flamm: Chair votes yes. Fifteen yes; zero no. 

Miles McEvoy: Conflict of interest was missed. 

Barry Flamm: Sorry? 

Unknown Males: Conflict of interest [inaudible]

Barry Flamm: We did it way back.

Unknown Persons: No.

Barry Flamm: Did not we? 

Miles McEvoy: No. You did it for the two other substances. You did not have disclosure of 

interest for this particular substance. 

Barry Flamm: I thought we, so much time passed, I thought we already did it. Is there a conflict 

of interest? You are excluded I think, Zea, by... 

Zea Sonnabend: I have actually no idea if this is in anything from CCUF. The other things I 

knew, but I work for a certifier that may or may not certify products with this in it. 

Miles McEvoy: Is that it? Okay. 

Barry Flamm: Yeah, that is it. So it is ...

Miles McEvoy: No recusal necessary. 

Nick Maravell: Barry, I have a question. 

Barry Flamm: Yes.

Nick Maravell: Just, just out of curiosity, I thought our Policy and Procedures Manual, or maybe 

it does not say this, says it is the responsibility of Board members to bring forth their 

potential conflict of interest, does, does that mean we cannot rely upon the good faith of 

the Board members but we do have to seek it every single time? 
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Miles McEvoy: Yeah, the, the process has been that before every substance is voted on, that the, 

the Chair ask that question, are there any interests that need to be disclosed, any conflicts, 

anybody want to recuse themselves? So that has just been the normal process for each 

substance, so, you know, we are just getting started here, so get into the swing of things 

so we will be fine. 

Barry Flamm: Okay, bec-, I do not know if I gave the results yet, but it is, I will repeat it in any 

case, it is 15 yes. Zero no. The motion passes to list calcium sulfate. John, we going to try 

one more?

John Foster: We are going to try for one more. 

Barry Flamm: Pick an easy one. 

John Foster: We are going to try for glucono delta-lactone, another Sunset proposal. This is 

glucono delta-lactone on 205.605(a). Joe.

Joe Dickson: I move to accept the Handling Committee's Sunset proposal to re-list glucono 

delta-lactone production by the oxidation of d-glucose with bromine water is prohibited 

to 205.605(a) non-synthetics allowed. Is there a second? 

Unknown Male: I will second. 

Barry Flamm: We have got a motion and, and it has been seconded to re-list, I will just say GDL.

Is there a conflict of interest? 

Zea Sonnabend: I have no idea but maybe. I work for a certifier that may or may not certify this. 

Barry Flamm: I think you are home free. 

Unknown Male: It is getting redundant.

Barry Flamm: Oh, John.

John Foster: Earthbound is getting into beverage, beverage manufacturing and we may, in the 

future, in the near future, use a co-packer who might use this as a, as a material. 

Miles McEvoy: Okay, is that it? That is ...

John Foster: That is it.

Miles McEvoy: ...that is good. 

Unknown Female: Joe, is fun party?
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135

Joe Dickson: For the sake of transparency, I will get on this conflict wagon. I work for a retail 

organization that sells products made with every single item on this agenda, if you 

consider that a conflict of interest. 

Miles McEvoy: Thanks, Joe. In these situations, you do not, none, none of the folks that

disclosed their interests need to recuse themselves. 

Joe Dickson: Thank you. 

Zea Sonnabend: But we still have to do this every single vote?

Miles McEvoy: That is the process that has been the standard process for materials for, for all 

motions is that there is that question before the final discussion and vote. 

Barry Flamm: Discussion? Any discussion on this material to be re-listed? Hearing none, we will 

start the voting with, with Nick.

Nick Maravell: Yes. 

The Entire NOSB Board: No. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. Yes.

Barry Flamm: Yes. Fourteen yeses; one no. The motion carries.

John Foster: Mr. Chairman, in light of the time and the kind of the sense of, of the Handling 

Committee, I think that we are going to wrap that up for today. We are going to need to 

carry over the next votes to tomorrow. This, and I would like to request that the Handling

Committee have a quick, a quick meeting in preparation for that to my right after this. 

That is all we are ready to do. 

Barry Flamm: I have an announcement to make. The New Mexico Department of Agriculture 

Organic Program reception has been moved to Salon E.

Unknown Male: To what?

Barry Flamm: Salon E. I guess that is a room or a conference room.

Unknown Male: Yeah, thank you.

Barry Flamm: And the time is the same as the invitation, 5:30 to 7:30. 

Unknown Male: 5:30. That is in three minutes.

Barry Flamm: We will recess until tomorrow morning at 8:00. 

[Event concluded] (End )
Meeting Of The National Organic Standards Board

May 25, 2012

1

United States Department of Agriculture

Agriculture Marketing Service (AMS)

National Organic Program (NOP)

Meeting Of The National Organic Standards Board (NOSB)

May 25, 2012

Hotel Albuquerque Old Town

800 Rio Grande Boulevard NW 

Albuquerque, NM 87104

The National Organic Standards Board convened at 8:00 a.m. with Barry Flamm, Chairperson, 

presiding.

Members Present

Barry Flamm, Chairperson

Harold Austin

Carmela Beck

Colehour Bondera

Joe Dickson

Tracy Favre

Jay Feldman

John Foster

Wendy Fulwider

Nick Maravell

Jean Richardson

Zea Sonnabend

Robert “Mac” Stone

Jennifer Taylor

Calvin Reuben Walker 

National Organic Program Staff

Miles McEvoy, Deputy Administrator

Melissa Bailey, Director, Standards Division

Dr. Lisa Brines, National List Manager

Emily Brown-Rosen, Agricultural Marketing Specialist, Standards Division

Michelle Arsenault, NOS Advisory Board Specialist

**Please note that this transcript may contain errors or omissions and does not represent an 

official record of all proceedings that took place on May 25. Please refer to the live webcast for a 

more accurate representation of the meeting.
Meeting Of The National Organic Standards Board

May 25, 2012

2

TABLE OF CONTENTS

PAGE

Deferred Proposals and Final Votes................................................................................. 3

 Livestock Committee .................................................................................................... 3

 Policy Development Committee.................................................................................... 5

Break................................................................................................................................ 6

Deferred Proposals and Final Votes (continued).............................................................. 6

 Handling Committee ..................................................................................................... 6

Break.............................................................................................................................. 34

Deferred Proposals and Final Votes (continued)............................................................ 34

 Handling Committee (continued)................................................................................ 34

Break.............................................................................................................................. 45

Committee Workplans ................................................................................................... 45

Other Business and Closing Remarks ............................................................................ 53

Adjournment .................................................................................................................. 57
Meeting Of The National Organic Standards Board

May 25, 2012

3

Barry Flamm: Board members, please take your seat. The NOSB Board meeting is back in 

session. Good morning. 

The Entire NOSB and Crowd: Good morning. 

Barry Flamm: We have an incredibly busy morning this morning. And I am going to give you 

the agenda for this morning. From 8 o’clock to 8:15, Livestock will present a proposal

which will require voting. From 8:15 to 8:30, the Policy Development Committee will, 

will make their report. From 8:30, 8:45, the Handling Committee has requested a, a brief 

period where they can huddle and get together for, for their presentations this morning. It 

will be, then, the Handling Committee for the rest of the morning until 11:30, with the, 

with their Sunset and petition items. At 11:30 to 12 o’clock, is work plans will be 

presented. Each Committee will be allowed three minutes to present their work plans for, 

for the next fall and spring. And, and this meeting will end at 12 o’clock according to the 

official agenda. So, if the Livestock Committee will proceed? Wendy, please?

Wendy Fulwider: Thank you, Barry. I would like to refresh everyone's memory as to the 

Livestock [inaudible]

Unknown Female: Mic.

Wendy Fulwider: Sorry. Thank you, Barry. I would like to refresh everyone's memory as to the 

Livestock Committee's discussions on Wednesday. And as a result of public comment, 

the Livestock Commit-, Subcommittee would like to, more information to move forward 

with our work on the GMO vaccines. We would like to make a request to the Program

and Secretary to get the information that we need. Nick, would you please present the 

document? 

Comment [JMS1]: 00:41:10
Meeting Of The National Organic Standards Board

May 25, 2012

4

Nick Maravell: Well, I will, I will present what I have. But, my, I cannot seem to connect to the 

Internet, so I do not have the document, so bear with me. Given the full way of public 

comment, we felt we had a very constructive discussion here about the use of GMO

vaccines in livestock production. And, we feel that we need more solid information in 

going, in order to go forward. And, we are proposing a resolution of this Board to send 

our request to the Program, to basically do three things. 

The first thing is to establish a list that would be specific to pathogens by strain, and that 

list would make reference to the known registered vaccines. And, that list would include 

an indication of which of those vaccines are produced by the definition of excluded 

methods, and those which do not. 

We, the second thing is, we would request that there is a regular procedure to update that 

list. We are suggesting real-time, as it happens, as new registrations come in. So that 

producers, certifiers would all be able to look at one list. 

The third thing that we are requesting is to in, use the auspices of the National Organic 

Program to encourage vac-, vaccine manufacturers to voluntarily identify the absence of 

GMO technology on their vaccines. So, in other words, if you were to buy one at a 

livestock supply store, it might say, produced without GMO technology or without 

excluded methods or something. But, this would be encouragement and it would be 

voluntary and it would not be anything that would be required. But, it would be 

verifiable, because certifiers could verify, indeed, this is a truthful label claim, because I 

can go to the accessible list. 

And, the fi-, last thing, that we, what we have said, is that we are going to continue to 

work on a list of questions, some of which have already been posted on the NOP website, 

that would better inform the policy making on the use of GMO vaccines in livestock 

production. And, we, we are going to refine that list, accept additional comment on that 

list of questions. And work with the Program to see how it might be possible to get that 

information that might be useful for the community, and, and for the NOSB to make 

policy in this one area of GMO vaccines. 

So, that is the essence, and it, it looks like -- oh, and we are requesting ... Thank you. 

Wendy, it is up on the screen. Okay. We are also requesting that at the next meeting in 

Providence, and the next spring meeting, that we revisit this issue, and get a, basically, an 

update. And, and we may also put out something in the Federal Register during the 

meeting agenda to, to indicate that we might want additional input on specific questions

as we move forward on this. Do I? Okay.

So, I would make a motion that we pass a resolution of the Board, addressed to the 

National Organic Standards, National Organic Program as outlined in the document that 

is on the screen which was approved unanimously after taking into account all concerns 

that we were able to, legitimate concerns we were able to identify, so approved 

unanimously by the Livestock Committee. So, I move that we adopt that and forward that 

resolution to the National Organic Program. 

Comment [JMS2]: 00:45:00
Meeting Of The National Organic Standards Board

May 25, 2012

5

Barry Flamm: Do we have a second? 

Wendy Fulwider: I second that. 

Barry Flamm: It has been moved and seconded, the, the Livestock Committee resolution, which 

you see shown on the Board, be adopted. Is there any conflict of interest? Hearing none, 

we will proceed with voting, Jennifer leading off. Jennifer.

Jennifer Taylor: Yes. 

The Entire NOSB Board: Yes. Abstain. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. Yes. 

Yes. 

Barry Flamm: The chair votes yes. Four, 14 yes, zero noes, and one abstention. Thank you, 

Livestock Committee. We will proceed to Policy Development Committee report. 

Unknown Female: Barry.

Barry Flamm: The Program has a comment to make. 

Miles McEvoy: Yes, the NOP welcomes the resolution. We will evaluate the resolution and 

respond back to the Board with a full response. We will explore the concept of 

developing a GMO Vaccine Working Group consisting of NOSB Board members, NOP, 

APHIS, and other relevant technical experts. So thank you very much for this work and 

we look forward to continuing to work on this issue with the Board. 

Barry Flamm: Thank you for those comments. Colehour, would you proceed? 

Colehour Bondera: Very good. Thank you. Speaking to you as the Chair of the Policy 

Development Committee, and I have two things I would like to do in a short amount of 

time. And actually, it will only take a very short amount of time, to be frank. The first one 

I want to do is to withdraw the three proposed recommendations that were put forth at 

this point in time, given the fact that, to be frank, we are out of time. So, that said ...

Barry Flamm: Before you move on to the next point, without objection, the Policy Committee’s

request to withdraw their prop-, three proposals is accepted. Continue, Colehour. 

Colehour Bondera: Thank you, Mr. Chair. I, I, after meeting with the Policy Development 

Committee and discussing with other Board members, I am prepared to, and would like 

to make a statement from the Policy Development Committee to enable our efforts to 

move forward more smoothly and functionally in the future. And, the statement is on the 

screen. Our Committee hereby requests complete written communication from the 

National Organic Program regarding how FACA informs our policy efforts.
Meeting Of The National Organic Standards Board

May 25, 2012

6

And, we have kept that fairly simple and straightforward. And, we are not, you know, 

thinking or wanting there to be any difficulty in this. Instead, we would just like 

something written in our hands that we can reference, so we know what process is going 

to be occurring. Because, several people, at least, have felt that the un-clarity of what 

things are going to be happening at what stages has led to the, the place we are at where 

we have resulted in withdrawing the recommendations that we have worked on this 

session. So, that is the request we have made. I do not know if the National Organic 

Program needs to or would like to respond right now. And I understand either way, but, 

but that is what I would like to put the table. Thank you. 

Miles McEvoy: Yeah, that is fine by us. And we look forward to providing more specific 

information and collaborating with the Policy Development Subcommittee. 

Barry Flamm: Thank you. With that, we will... Oh, Zea, you have a question? 

Zea Sonnabend: My question is just of concern over the portion of the recommendations about 

having a public docket open between meetings. And I am wondering if maybe, since I do

not think that is the convert-, controversial part of the recommendation, if the Department 

could explore that in between this meeting and the next meeting without having a motion 

on it? 

Miles McEvoy: Yeah, we are already exploring that option and looking at ways that we can 

make that happen. 

Zea Sonnabend: Thank you. 

Barry Flamm: Okay, at the request of the, the Handling Committee, we will, we will break for 15 

minutes while they huddle, have a word, and then, we will get, we will return and, and

proceed with the formal presentations of the Sunset items. 

BREAK

Barry Flamm: Board meeting is back in session. The Handling Committee will continue, please. 

John.

John Foster: Thank you, Barry. We will continue – [cough] sorry – we will continue with 

handling materials, picking up from yesterday. We have six materials to, to vote on 

today. We have a hard stop at 11:30. The Committee work has a hard stop at 11:30, so we 

are going to correct, re-prioritize, make sure that we can get to Sunset first. And then we 

will do petitioned items. We will start off the motions with carrageenan. Carrageenan.

Barry Flamm: Is there a motion on Carrageenan?

Joe Dickson: I move, I move that we accept the Handling Committee’s recommendation. I will 

read it as it has been modified. At this time, we would recommend the re-listing of 

carrageenan on the National List 205.605, non-agricultural non-organic substances 

Comment [JMS3]: 00:54:05

Comment [JMS4]: 01:16:47
Meeting Of The National Organic Standards Board

May 25, 2012

7

allowed as ingredients in or on processed products labeled as organic or made with 

organic specified ingredients or food group or groups. We recommend re-listing under

605(a), non-synthetics allowed. 

We would also include the following two annotations. The first annotation, only 

carrageenan that is in one of the following four CAS numbers will be allowed for use as a 

food additive: 9000-07-1 (general), 9062-07-1 (Iota), 11114-20-8 (Kappa), and finally 

9064-57-7 (Lambda). All other CAS numbers would not be recommended for use in food 

production as an ingredient or otherwise. 

The second annotation, carrageenan would not be allowed for use in infant formulas. We 

would also recommend that the listing be revisited once the NOP has finalized the draft 

guidance submitted by the NOSB on November 5, 2009. Re-evaluation of the materials 

classification, agricultural, non-agricultural, synthetic, non-synthetic should be 

considered to ensure that the listed material has been properly classified and thus remove 

any further confusion from its status thus helping to, to, during future reviews. 

Barry Flamm: Is there a second? 

Unknown Female: Second. 

Barry Flamm: The motion to re-list carrageenan has, has been seconded, and we will have 

discussion now. John and the Chair, Subcommittee Chair will lead the discussion. 

John Foster: Alright. Other questions or discussion items? I have got Zea, then Jean. I am sorry, 

Zea, then Tracy. 

Zea Sonnabend: Thank you. We realize that concerns have come to us about this material in the 

last month. And yet, we have also heard from a number of companies that these concerns 

are news to them, too. And, even the most highly rep-, high integrity and conscientious 

companies have stated that they are going to need some time to try and remove this from 

their products. And so, we would like to proceed with the re-listing of this, but, to put an 

accompanying statement somehow that says, the Board intends to explore these concerns 

further, and put the community on notice that we would like it to be off the List by the 

next Sunset period, if possible. 

John Foster: Thank you, Zea. Tracy?

Tracy Favre: In an effort to make sure I understand the process for Sunset review, I have done a 

little exploration, including looking at the Policy and Procedures Manual on Sunset 

review. There is sort of a decision tree that helps us understand that process. In particular, 

there is three criteria for evaluating whether or not a material should come off the List. 

And that is, there is three. The first is whether or not it is harmful to human health and 

the, or the environment. Number two, it is unnecessary because of avail-, availability of 

alternatives. And number three, it is inconsistent with organic farming or handling. So I, I 
Meeting Of The National Organic Standards Board

May 25, 2012

8

urge all of us on the Board to keep those three criteria in mind as we are looking at 

evaluating whether or not to re-list this substance. 

John Foster: Thank you, Tracy. Further discussion items, questions? Jay? 

Jay Feldman: Thank you. And, I appreciate your comment, Zea, on, on this. In a perfect world

that approach would probably work. That is, we put, to quote you, the industry on notice 

or manufacturers on notice. Unfortunately, having studied the history of the Board and 

actions on, on materials and processes that have been identified as problematic by this 

Board, that kind of operationalization of a, of a view, that does not seem to result, to 

ensure results unfortunately. 

So, I believe, and that is why I have been an advocate for expiration dates, because I 

think it offers industry an opportunity to adjust. It creates a date certain. It establishes a 

decision that the industry can be sure about. There is, there is no equivocation in that.

And, it allows us to meet our statutory responsibilities to take action on the material. I 

think the Committee made a lot of progress in, in moving this issue and being responsive 

to the public, and I appreciate that, in terms of amending the, the proposal that first came 

out of the Committee. 

You know, one of the things that we have to do as a Board when we evaluate science is 

recognize that what decisions were based on before us may not have been, may need 

updating, may need to be re-evaluated, I think along the lines of what Tracy just said. It is

our responsibility to re-evaluate the science and obviously that is why we get these 

technical evaluation reports. If you look back to the original decision and the science that 

supported the listing of this material, I think and we did not have a full discussion of this, 

but I think you will find it very unsatisfactory. 

You know, one example of that is the reference to GRAS. And GRAS, we can have a 

day-long seminar on GRAS and issues around generally recognized as safe, and how 

FDA a, arrives at that. But the, and, and I would be happy to read to you a recent GAO

report that came out last year that identifies the deficiencies in GRAS in reading, in 

reaching scientific determinations, in general. But, when you look at it relative to what 

our responsibilities are to look at adverse impacts on health and the environment, the, the

process is, is wholly deficient. And, and so, you know, if you view the G, the US 

Government Accountability Office, an arm of Congress, as something that is useful, I 

think that, you know, we have to take that into account. 

So, what we do with this TER, is we, we look back and we identify implicitly that the, the

original scientific basis for the listing was in some way limit, limited. And, we are 

updating it through this TER, right? So, the TER then identifies a range of scientific 

opinions on these things. And this is classic. You have seen it before in your work, right? 

We get different opinions, scientific opinions on where, where things are at, on different 

opinions on what the science says, what it means, what its implications are, in terms of 

use. 
Meeting Of The National Organic Standards Board

May 25, 2012

9

I mean I have been dealing with this personally, professionally, on materials regarding 

pesticides for, for years. And I can tell you, we debated chlordane, we debated 

chlorpyrifos, dursban, and in every one of those situations over decades, we debated with 

EPA the, the science. You know, what is the science on this side? What is the science on 

that side? And we came to the conclusion as an organization at Beyond Pesticides that 

uncertainty was not in the public interest because in most of those, in virtually all of those 

situations where we had the science, like you know of, of independent scientists, we had 

industry scientists, we had academics who were supported with industry money, et cetera, 

et cetera. We have government money supporting other scientists, whatever it is. We 

have seen these wrenching debates on dis-, and discordance among in the scientific 

community. So what do you do with that? 

Well, we turned to organic for that. That is why we got involved with organic. Because 

we said that, you know, this is a place, as I said yesterday, where we can eliminate 

uncertainty to the highest degree possible. This is not a place like the conventional food 

system, we believe, this is our opinion, Beyond Pesticides, where we can and should 

accept the degree of uncertainty on hazards. 

Now where does the uncertainty come in with carrageenan? Okay, we have got, we have 

got the International Agency for Research on Cancer that has identified de-graded 

carrageenan as a carcin-, as a carcinogen. Okay, that is, in our organization, we use the 

International Agency for Research on Cancer historically for determinations. It is a 

respected international body. And, and so, the, the carcinogenicity issue seems to be a 

real one. I had not heard anyone during our proceedings dispute the cancer issue. Did I? 

Zea Sonnabend: [Inaudible]

Jay Feldman: Okay, then you will do it in a few minutes. Okay, so anyway, you have got this, 

you have got this cancer finding. Now, does that apply to the, to the high molecular 

formula or weight formula? Or, does it only apply to the food, the food grade material? 

Or, does it only apply to the de-graded, and to what degree is de-graded is showing up in 

food grade? So in that respect, my, my sense is we have a, we have some degraded. We 

do not know how much that is in it, in the... We have de-graded carrageenan in the food

grade. We do not know how much of the de-graded is in there. And, we do not have a 

proposal on the table that limits it in any way. 

John Foster: Hey, Jay, can we... 

Jay Feldman: Yeah.

John Foster: I want to make sure that we get a lot of other voices, too. [Inaudible]

Jay Feldman: Okay. So, so the bottom line is that if we have a carcinogen, even in percentages in 

five, the 5 to 10 range, we are exposing the public to a carcinogen. And, when you have a 

material that has a no threshold dose, no one has brought to this proceeding, because we 

cannot, an identification of an exposure to a carcinogen that in, that does not result in 
Meeting Of The National Organic Standards Board

May 25, 2012

10

initiating or promoting carcinogenesis. This is the, the safe place of organic. We do not

bring carcinogens to the table. We do not do that. It is not a part of our ethic or our fabric. 

And so, we are not even getting into the, the debate of whether somebody believes there 

is a, a weight of evidence that you can bring to this argument of carcinogenicity. We have 

elim-, we have traditionally tried to eliminate carcinogens. So then you get to the issue of 

necessity and, and on and on. And, and so, I think, I think we, we have a duty to reject 

this. 

I would like to see some sort of phase out that recognizes this caught everybody by 

surprise, that this was not something on the table even a year ago. And so, in good faith, 

I, I am, this is why I am a proponent and have been since I got on the Board, of, and in 

my work with EPA as well, for expiration dates. I know the Program does not like them. 

But, I think it, it allows us to affect a transition in an orderly way and give the industry an 

opportunity to retool so that we can meet the standards and feel we are doing it ex-, 

expeditiously in the quickest time possible. 

I am looking for a compromise here, John, and I just want to, I apologize the amount of 

time I took. But I wanted you to understand that this is based on what I believe the 

history of our involvement in issues that involve carcinogens is, carcinogenesis and, and

other health impacts that we heard about in terms of, of the research that was presented to 

us. Thank you. 

John Foster: Thanks. Other comments? Harold? 

Harold Austin: I think to further clarify a little bit for the comments that Jay just made. 

Regarding the scientific information and re-evaluation, the data is the same flo-, the same 

data that has been out there since this product was originally listed. It is, the argument is 

still the same, being made by the same science, by the same studies, by the same author 

that have been continually rejected by fellow scientists and that the majority of the World 

Health Organizations repetitively over the last 18 years. There was nothing new that has 

been presented that has not already existed.

What we have done is we have researched, looked through the different testimonies, 

looked through the data during the review of this material. The things that have been 

brought to light, is that there is a distinct difference between the high molecular 

carrageenan, the low molecular polygeenan. There has also been reference made to the 

fact that there is some concerns about newborn infants up to the age of four months. We 

have included that. I do not think we have the expertise to take on every world health 

organization that is out there and defute [refute] what they are saying and what they are 

accepting. I think that is a travesty to our stakeholders. 

I think we have put the consumers on notice. I think we have put the stakeholders on 

notice that there is an issue, a potential issue, with this material. I think we are putting in 

place the safeguards that are necessary to continue to allow, to allow this material to go 

out to our stakeholders, while at the same time, serving ner-, notice that they need to do

Comment [JMS5]: 01:30:00

Comment [JMS6]: Defute in the Urban 

Dictionary means to refute a comment in an 

argument in a dirty way. I do not think Harold 

meant to use this word. 
Meeting Of The National Organic Standards Board

May 25, 2012

11

more in-depth research in order to make sure that we do have a material that truly is safe 

for the consumer. And I think if that research has not been provided to the Board by the 

time this comes back up for review in five years, then I think the outcomes could possibly 

be a totally different outcome. I really do. 

But, I think, I think to allow this to go through the, the Sunset review process to, to re-list 

it, I think is the right move for the right reasons, knowing that we have, we have really 

bought a lot of materials, a lot of things out to the forefront on this issue on both sides of 

it. And I, I think, that is a fair evaluation as this Board, representing all stakeholders in 

the organic arena. 

John Foster: Thank you, Harold. More discussion? Oh, Zea.

Zea Sonnabend: Okay. I just have to refute the cancer claim. What is on the AR, AI – right, okay 

– it is polygeenan, ten to thirty dal-, [cough] thousand daltons. I am going to read brief, I, 

I think there are valid concerns raised about inflammatory properties of carrageenan. The 

cancer studies of which there are three, on food grade carrageenan, involved injecting rats 

with tumor provoking chemicals and then injecting them with carrageenan, to see if they 

actually got to, canc-, tumors from the injections. And in two of the studies, they did get 

tumors, and in one of the studies, they did not. But, they were injecting like 10 to 20 

times the average human daily dose into rats.

So, I can read you these paragraphs from the research. But, it is absolutely 

unsubstantiated that eating food causes carrageenan, eating food carrageenan causes 

cancer. And, while I still have the mike, because you did not call on him, I am going to 

from the British report, which is the most recent review of literature, it says, there is one 

issue upon which the Committee felt further research should be undertaken. The 

possibility that native carrageenan could cause significant amounts of polygeenan, either 

by processing techniques or by acids during digestion. This is the val-, to me, this is the 

valid concern. The Committee suggested, if feasible, a molecular weight limit of below 

5%, less than five percent below 50,000 daltons should be introduced into the 

specifications to ensure the presence of low molecular weight carrageenan in food is kept 

to a minimum. So, I, further research, that is the key point; the inflammation, the cancer, 

forget it. 

Crowd: [Laughing] 

John Foster: Yes, Jay? 

Jay Feldman: Sorry, John. 

John Foster: [Laugh]

Jay Feldman: I just have to say, I mean this, obviously we, again, me, we, the organization I 

work for, have been through these cancer debates for decades now. We do not test on 

humans in this country, or in most of the world. And certainly, EPA does not even accept 
Meeting Of The National Organic Standards Board

May 25, 2012

12

canc-, human studies. They will accept studies, occupational studies, from the workplace 

that are basically epidemiologic studies that look at exposure in different settings. They 

have done farmer studies. That has helped us to remove a lot of pesticides in agriculture. 

But, they do not rely on those studies. They rely on animal studies. This is how we test in 

our modern world for adverse outcomes. And in, in the area of cancer, we test at 

maximum tolerated doses. Right? I mean, a lot, I am telling a lot, a lot of you know this 

already, and I apologize. But, I have to, I have to dispute what you are saying, Zea, 

because these are the protocols we utilize for classification of materials. We, we are not, 

not, not the classification of materials we talk about on this Board, but in terms of 

pointing to other institutions that identify cancer-causing chemicals, you cannot find any,

with the rare exceptions, and those are the ones that we have found through 

epidemiologic studies, after they have been out in the market, like arsenic or arsenical 

materials. You cannot find any other studies except laboratory animal studies that 

identify carcinogen-, carcinogenesis. That is what we use in our, in our st-, in our world 

today. 

So, when the International Agency for Research on Cancer describes its study protocol, 

which involves the injection of a material into the organism, that is then extrapolated and

they come up with their classification, possible carcinogen, probable carcinogen, you 

know, the, the different classifications, based on the strength of the, of the reaction. And, 

that is the methodology that is used. It is used worldwide. It is accepted as a 

methodology. So to pull out the study design and protocol and to, to say to lay people, 

how could you accept a high-dose animal experiment as indication that low-dose 

exposure in the food supply is going to cause an effect, is, is quite outrageous, I, I must 

say, given that these are the protocols that are utilized worldwide in our own government 

to make determinations on cancer outcomes, and on other outcomes, as well. 

In fact, years ago, there was an attempt to try to do low dose experimentation in 

laboratory animals, because again, we do not test on humans, where they set up a million 

control group, and a million so they could get their levels for 1 million. We look at cancer 

in levels of excess levels of cancer per million population. And, it was a dramatic failure. 

We realized we could not do that. So, we went to, we tried, gov-, you know, science tried 

to do that. And, it, it went to this maximum tolerated dose, high-dose exposures, low 

numbers of animal population, extrapolated to humans. And that is all we have got to go 

on. So, to dispute the science and the finding and classification of the International 

Agency for Research on Cancer, IR ...

Zea Sonnabend: [inaudible]

Jay Feldman: This is, this is part of the degraded, part of the degraded material that is showing 

up in food grade carrageenan. Unfortunately, this is a common problem where we have 

contaminants or we have materials, as you all know, in our ingredients that are not 

intended to be there. They are not purposefully added, you know, but, they show up. And 

unfortunately, you cannot ignore them. If we are going to do our job as a Board and we 
Meeting Of The National Organic Standards Board

May 25, 2012

13

are going to provide the public with clean food met, that is meeting a standard, this is 

what.., this is the rigor with which we have to look at these things.

John Foster: [Inaudible] interrupt.

Jay Feldman: Please do not dismiss findings of, of agencies that determine classification of 

materials. 

John Foster: More voices? Alright. As they say, last call. Oh, Colehour.

Colehour Bondera: Yes, thank you, John. I, yeah, I admittedly am hesitating because I am not 

sure that I have something to add. But, when you said more voices, I can go ahead and 

add more voice. Because, I think that in my opinion, based upon what I have read and 

heard and as Tracy said, attempting to follow the policy that we are subject to be 

utilizing, my personal conclusion is, I guess along the lines of what, I think, correct me if 

I am wrong, but I think Zea brought up is that, you know, we need to try to address this 

topic by recognizing its current, it, its reality, what, where it is used and how it is used at 

present. But, then to try to look at, you know, maybe we should be raising the flag to this 

for the, from my perspective, for the various health reasons are, are a big emphasis, and, 

and I think that one of the other big issues is related to this, the, the science that is quote 

unquote, proving different things seems all over the map. But, I, and that is up to 

interpretation for better or worse. 

But, I think that I could support, if there were a something to this recommendation that 

specifically said a date that was well before the five-year time frame. Then I could see 

that being something that I understand that the current industry cannot change overnight. 

And so, you know, if we put in a two or three-year time and said this is as long as it goes 

to and then it goes and, you know, it has to get re-reviewed at that process or whatever, 

then, then I think, and, and you know, looking, you know, have more, put some pressure 

on getting some more research done as, as necessary, et cetera, I, I could see wavering on 

my, my conclusion, which is, you know, not in support of, of the recommendation as it 

stands. And I hope that that makes sense. Thank you. 

John Foster: Thank you, Colehour. Tracy? 

Tracy Favre: You know, as someone new on the Board and going through this process, it has, it 

has been interesting to me to try to tease out where I stand on things, based on the fact 

that the science reports are coming in on both sides. I think, probably the only thing I 

would want to remark on is I am, I am a little bit troubled by this sort of piling on 

mentality that we have seen on some of the public comments, and my own personal 

nature is to be very cautious if there seems to be sort of a momentum that springs up out 

of nowhere and comes on board. Everybody is going to pile on board against something. 

That, that raises a red flag for me for a lot of reasons. Particularly when the science has 

been so ambiguous, and when some of the material that was presented as science has 

been sort of debunked by other scientists.
Meeting Of The National Organic Standards Board

May 25, 2012

14

I think it is really incumbent upon us to not let sort of that momentum of, I will not call it 

hysteria, that is a perjorative, I do not mean it that way, but, the momentum of negative 

feeling to kind of swell at the last minute and sort of stampede us into making a decision. 

And is, and as someone who is grappling with this for the first time, it seems to me that it 

would be wiser for us to proceed cautiously, and to get more updated information before 

we let sort of that tide of momentum sway us because this does have far-reaching 

consequences, not only for the individuals that depend on this for their livelihood, but 

also for the industry that manufactures products for it and with a long time to reformulate. 

So, I do not really have a question. It, it just seems to me that anytime there is this swell 

and this momentum, rushing towards judgment, my personal inclination is to actually 

slow down, rather than speed up because there is usually a reason for that rush.

John Foster: Thank you. We are going to, in the, knowing we have got a lot of materials, we, we 

are about a half an hour into this material, so I am going to wrap up that. I did ask for last 

call, which I think everyone recognizes. So, a good discussion. I think a lot, I think all, all

kind of different opinions were, were voiced there. Yeah, well, the motion has been 

made. It has already been seconded, so we had the discussion. We can move on to voting.

Barry Flamm: John, I, I heard some, it sounded like interest in, by a couple of members, of 

perhaps of amending the motion. And I just want to see if that was something on, on the 

table. I think that, I think Zea sort of hinted at, at something, Jay and Colehour. And 

before moving on with the vote, I just want to see if there is, if there is a desire to propose 

an amendment.

Zea Sonnabend: I did not suggest an amendment, just a statement to go along with it that we 

intend to take it off after the five-year Sunset period. 

Barry Flamm: Jay? 

Jay Feldman: May I respond to that? You know, normally, I am inclined to put, put forward a 

compromise. But, it seems like that strategy does not work too good. [Laugh] So, I am, I 

am just going to vote it down. I, I do not want to do that, but I am not, we are not getting 

support from the Program, typically, regarding expiration dates, despite the fact that most 

of the peop-, the manufacture, or many of the folks that provided statements suggested 

they were looking, moving in this direction, and were looking for alternatives or open to 

looking to alternatives. 

This is not my preferred position, but, the compromise thing does not seem to work too 

well. So, I am, I am just going to vote against it, Barry, unfortunately. I would, I would

love to see support for a compromise on this. That is where I would want to go. That is 

where I want to go. But, I do not see, I do not see that happening. And so, if I cannot get 

a decisive vote on the compromise, I lose my opportunity. I just, I just would like to go 

forward with the compromise and feel there was support before putting a motion forth. 

Barry Flamm: Colehour.

Comment [JMS7]: 01:45:00
Meeting Of The National Organic Standards Board

May 25, 2012

15

Colehour Bondera: Yes, thank you. And, Barry, maybe you can clarify for me. I am not sure but 

my understanding of the process, that, that, and Zea, I appreciate your, your clarification 

and thoughts. I think I understood fine. But, my understanding is, you know, if ... We 

would have to vote to reject a product and then it would have to be re-petitioned for it to 

be, you know, we cannot, at this point in time, decide that something would come off. It 

is just a hypothetical that in five years, at another Sunset, the NOSB could vote to, to not 

support it. And so, if we made a statement, that would not have any impact. So that is my 

understanding of the process anyway. 

Barry Flamm: You, you could propose an amendment to the, the motion that, with an alternative 

date. But, Jay has explained the, you know, the problems with that. But I just wanted to 

give, you know, anybody who suggested something to that effect, so I just wanted to give 

that opportunity before taking a vote on the motion. 

Zea Sonnabend: Barry, can I ask a question? This is a point of procedure but if this motion fails, 

could not somebody bring back a motion for a, a alternative date for expiration? That 

would be the compromise.

Barry Flamm: I do not know if we have ever done that. I, I suppose we could. 

Zea Sonnabend: We have in, the NOSB has in the past. 

Barry Flamm: Have we? Okay. I would, I would be open to that. Nick.

Nick Maravell: Is, is there some way to get a sense of the Board whether a compromise position 

would indeed be likely to get a decisive vote? I, I personally think a compromise position 

would be acceptable and I think this could very well be a decisive vote for that. 

Barry Flamm: So, what, what are you suggesting, Nick? 

Nick Maravell: Well, in the past, and I am a newbie here, still, I consider myself in terms of 

parliamentary precision, procedures, we, the previous chair would do something called 

like a straw vote. Can people help me out here? Is there... We used to do sort of a sense 

or a straw vote, where people were leaning, or am I making that up? I seem to remember

having... 

Barry Flamm: That has been discussed, but I am not, I am not enamored by that approach.

Nick Maravell: Okay, then I withdraw the suggestion. 

Barry Flamm: Okay. John, please.

John Foster: I just want to point out we have a, we have a motion and a second, we have had 

discussions, so I think there is a lot of options in front of us, but I, I feel like it is going to 
Meeting Of The National Organic Standards Board

May 25, 2012

16

get much more confusing if we, if we get in the middle with something else. Past 

experience is telling me that. 

Barry Flamm: Yeah, I will, I will proceed with the vote, then. Is there a con-, anybody have a 

conflict of interest? 

Zea Sonnabend: Barry?

Barry Flamm: Wendy, Wendy you want to ...

Wendy Fulwider: ... work for Organic Valley, and they do use carrageenan. 

Zea Sonnabend: I work for a certifier that may or may not certify products with carrageenan. 

Barry Flamm: Where, are you making the, the NOP decision? 

Melissa Bailey: Yeah. Do you want me to make it after each person? 

Barry Flamm: Yeah, I think we ought to do it after each person. 

Melissa Bailey: Okay.

Barry Flamm: So let us back up just a moment to, to Wendy. 

Melissa Bailey: Okay, Wendy, you do not have to recuse yourself because you, along with many 

food producers, all use carrageenan. You do not have a particular specific sole sort of 

agreement to... You are not the only one who has access to use that particular ingredient, 

so you do not have to recuse yourself.

Barry Flamm: Okay.

Zea Sonnabend: I have to say it again? 

Barry Flamm: Zea.

Melissa Bailey: Sure. 

Zea Sonnabend: I work for a certifier that may or may not certify products with carrageenan. 

Melissa Bailey: You do not have to recuse yourself. 

Barry Flamm: Jay, you had your hand up.

Jay Feldman: I work for an organization that receives support from Organic Valley and

Stonyfield for our national conference and scholarship fund. 
Meeting Of The National Organic Standards Board

May 25, 2012

17

Melissa Bailey: You do not have to recuse yourself.

Barry Flamm: Tracy? 

Tracy Favre: My organization has provided educational and training to Horizon Organic at their 

corporate owned dairies on pasture management.

Melissa Bailey: You do not have to recuse yourself. 

Barry Flamm: John? 

John Foster: One of Earthbound’s product lines has a minor ingredient in which a minor 

ingredient is likely to, it could be carrageenan, I just do not remember. But, it could be.

Melissa Bailey: You do not have to recuse yourself for the reasons I specified for Wendy. Joe? 

Barry Flamm: Joe? 

Joe Dickson: I work for a chain of retail stores that sells products which contain the ingredient.

Melissa Bailey: You do not have to recuse yourself, Joe. 

Barry Flamm: Anybody else? Okay, we will proceed with the vote, beginning with Jay. 

Jay Feldman: No. 

The Entire NOSB Board: Yes. No. Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. No. Yes. No. 

Barry Flamm: I know I have to vote. 

Crowd: [Laughing] 

Barry Flamm: This is a vote I do not want to make. It is probably the hardest vote I have had to 

make since I have been on the Board, and I have heard such incredible testimony on both 

sides of the issue. However, sitting in the environmental seat and believing in the 

precautionary principle, I have to vote no. 

Mac Stone: [Inaudible] 

Barry Flamm: What is the count? The vote is ten, 10 yes. Where is the, the other person? The 

vote is 10 yes, five noes. I believe I am correct, the motion carries. John, would you 

proceed with the next item?

John Foster: So traditionally we have done, when we have made changes, we have done a, a 

backup vote on Sunset items. Am I remembering correctly? Excellent. So, Harold, you ...
Meeting Of The National Organic Standards Board

May 25, 2012

18

Barry Flamm: That is correct.

John Foster: ... take that forward.

Harold Austin: I would move at this time that we move forward the backup vote to, to re-list 

carrageenan. 

Barry Flamm: And, and for clarification, that is a, the difference is that the annotation, it would 

not be there, is that right? 

Harold Austin: Correct. 

Barry Flamm: Do we have a second? 

Unknown Female: I will second.

Barry Flamm: It has been moved and seconded. Is there discussion? Hearing none, we will 

proceed with the, the vote. I do not think a, a question conflict of interest needs to be

taken again on this. Zea? 

Zea Sonnabend: Yes. 

The Entire NOSB Board: No. Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. No. Yes. 

Jennifer Taylor: My role is to represent the public and the consumers. No.

Jay Feldman: No.

Barry Flamm: I will vote yes. What is the count? 11 yeses, 4, noes. The motion passes. John, 

next item.

John Foster: Thank you. We will move on to agar agar. Harold, I believe you are the fortunate 

individual to carry that, also. 

Harold Austin: You are just bound and determined to continue to throw the new kid under the 

bus, aren't you? 

John Foster: [Laugh]

Harold Austin: Okay, our motion, as it has been modified on agar agar, at this time, we would 

recommend the re-listing of agar agar as it is currently listed on the National List, 

205.605, non-agricultural, non-organic substances allowed as ingredients in or on 

processed products labeled as organic or made with organic, specified ingredients or food 

groups non, (a) non-synthetic allowed. We would also recommend that this listing be 

revisited once the NOP has finalized the draft guidance for materials’ classifications. This 
Meeting Of The National Organic Standards Board

May 25, 2012

19

would help to ensure that the material has been properly classified and thus remove any 

further confusion from their status and help during future reviews. 

Zea Sonnabend: Second. 

John Foster: Thank you. Is there a second? 

Zea Sonnabend: I will second. 

Barry Flamm: It has been moved and seconded. Is there discussion on the motion? Zea. Oh, no, 

John, take over please.

John Foster: Alrighty. You got it. Zea? 

Zea Sonnabend: Okay. I just would like to put in the public record that we received some very 

good testimony from a gentleman who, with a lot of experience in colloid technology 

who indicated the flaws in the National List structure in regard to colloids, and once the 

classification of materials docket or guidance comes out, I do think we have to take 

another look at all the colloid materials and things like seaweed derivatives. 

John Foster: Jay.

Jay Feldman: You know I was hoping that the discussion would yield a more precise 

classification of this to the non-synthetic 605(a) listing. But, I do not think, it does not 

sound we are headed in that direction. So, I will be voting against this.

John Foster: Thank you, Jay. More comments, discussion? All right, seeing none, Barry, I think 

we can, Mr. Chair, we can proceed to vote. 

Barry Flamm: Okay, where are we at? Is there a conflict of interest? Zea.

Zea Sonnabend: I work for a certifier which may or may not certify products with this material.

Melissa Bailey: You do not need to recuse yourself. John.

Barry Flamm: John.

John Foster: One of our co-packers has a minor ingredient in a minor ingredient that might have 

agar agar in it. 

Melissa Bailey: You do not need to recuse yourself. 

Barry Flamm: Any other? 

Melissa Bailey: Joe. 

Comment [JMS8]: 02:00:00
Meeting Of The National Organic Standards Board

May 25, 2012

20

Barry Flamm: Joe.

Joe Dickson: My company sells many products which contain agar agar. 

Melissa Bailey: You do not need to recuse yourself. 

Barry Flamm: Any others? All right, I, we can proceed with the voting beginning with Calvin. 

Calvin Walker: No. 

The Entire NOSB Board: Yes. Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. No. Yes. No. No. Yes.

Barry Flamm: Okay, yeah. Yes. [Inaudible] The vote is 11 yeses, 4 noes. What is next, John? 

John Foster: Thank you. Next on the list is last, this is the last of the Sunset determinations, and 

this is for cellulose. Joe? 

Joe Dickson: Thank you, John. I would like to move that the Board accept the recommendation 

on the re-listing of cellulose to 205.605(b) synthetics allowed with the following 

modified annotation. Cellulose for use in regenerative casings, powdered cellulose as an 

anti-caking agent, non-chlorine bleached, and filtering aide. Is there a second? 

Unknown Female: Second. 

Barry Flamm: It has been moved and seconded. Is there discussion? John. I will turn it over to 

John. 

John Foster: Okay. Any discussion items on cellulose? [Inaudible] Thank you.

Joe Dickson: I just want to clarify that what that annotation does is clarify the, it strengthens the 

exclusion of microcrystalline cellulose by making it very clear that only the powdered 

form is acceptable under this annotation. It appears that that is what practice has allowed, 

but, you know, there is an opportunity to, to make it a little clearer so that is what that 

does. 

John Foster: Is, is that what you ...?

Jay Feldman: Just, thank you. I want to thank you for that.

John Foster: Okay. More questions, discussion? Okay, seeing none, I think we can proceed to 

vote. Oh, okay, I will ask conflict of interest on this one?

Barry Flamm: Declare... Jay.
Meeting Of The National Organic Standards Board

May 25, 2012

21

Jay Feldman: I work for a company that has received support for our national conference and 

scholarship fund from a manufacturer that uses, from Organic Valley that apparently uses 

it, according to the testimony. 

Melissa Bailey: You do not need to recuse yourself, Jay. 

Barry Flamm: Zea.

Zea Sonnabend: I work for a certifier that may or may not certify products with this in it. 

Melissa Bailey: You do not need to recuse yourself.

Joe Dickson: I work for a chain of retail stores that sells many products which contain this 

ingredient in different forms.

Melissa Bailey: You do not need to recuse yourself. 

Joe Dickson: Thank you.

Barry Flamm: Wendy.

Wendy Fulwider: We, at Organic Valley, may use cellulose. 

Melissa Bailey: You do not need to recuse yourself, Wendy.

Barry Flamm: I believe that we can proceed with the voting starting with, starting with Tracy. 

Tracy Favre: Yes. 

The Entire NOSB Board: Yes. Yes. Yes. Yes. Yes. Yes, sir. Yes. Yes. Yes. No. Yes. Yes. Yes.

Barry Flamm: Chair votes yes. What is the count? 14 yes, 1 no, the motion passes. 

Joe Dickson: Now, we need to do a backup vote to re-list the material as is. So I would move that 

we re-list cellulose to 205.605(b) with the annotation as it currently reads for use in 

regenerative casings as an anti-caking agent, non-chlorine bleached, and filtering aide. 

Unknown Male: Second. 

Unknown Male: Second.

Barry Flamm: It has been moved and seconded. 

John Foster: Discussion? 

Barry Flamm: Would you restate the, the motion for me on the annotation? 
Meeting Of The National Organic Standards Board

May 25, 2012

22

Joe Dickson: Yeah. The motion is just to re-list the material as it currently appears on the 

National List which is with the annotation: cellulose for use in regenerative casings as an 

anti-caking agent, non-chlorine bleached, and filtering aide.

Barry Flamm: Okay, it is... I will turn it over to John for a discussion.

John Foster: We have got a motion and a second. Is there discussion on this item? Jean.

Jean Richardson: So that would mean that the crystallized version could indeed be used? 

John Foster: In theory, although, I, I think, Joe, you were saying it is, and my understanding is 

that that particular kind is not in, is not used in commercial production. Joe? 

Joe Dickson: Yeah, I mean we have heard that the current thinking of both the Program and the 

Organic Materials Review Institute is that microcrystalline cellulose is a distinct 

substance that is not covered under the existing listing. But the, the modification to the 

annotation is simply to shore that up after some stakeholder comments expressing 

concerns. And this motion on the table is just the backup motion which is a procedural 

measure that basically ensures in the event that the changed annotation cannot go through 

the, the rulemaking process expediently, that the, the substance does not inadvertently 

come off of the List. 

John Foster: Additional questions or discussion? Okay, seeing none, I think we can proceed to 

vote.

Barry Flamm: And I believe we are covered on the ... We are starting. Okay. The voting is 

starting with Carmella. 

Carmella Beck: Yes. 

The Entire NOSB Board: Yes. Yes. Abstain. Yes. Yes, sir. Yes. No. Yes. No. Yes. Yes. No. Yes. 

Barry Flamm: The chair votes yes. 11 yes, 3 noes, and one abstention. The motion carries. Does 

that complete the Sunset items? 

John Foster: That does complete the Sunset items.

Barry Flamm: You wish to move on to the petitions? 

John Foster: All right, we will do that. And I just want to double check here. We have a break 

scheduled for about, in about half an hour, is that correct? 

Barry Flamm: That is correct. Would you like to take the break now or ...? 
Meeting Of The National Organic Standards Board

May 25, 2012

23

John Foster: No, I think this is, I think, I think we are, I think we are in a good groove. We can 

keep on. I, I would like to take a break around 10 though, if that is alright. 

Barry Flamm: We will do that. 

John Foster: Alright. Alright, next up is going to be the first of the petitioned items of the day. 

The first one up is choline. And, Zea, I believe you are point on that.

Zea Sonnabend: Thank you. Oh, that is not, oh yeah, it is the new version I gave you. It is just 

very big. Okay. Yesterday, or whenever that was that we presented the motion, we 

presented the amendment just to provide CAS numbers and be specific about what 

compounds we were talking about. 

Based on the testimony we received yesterday, we decided to put in an additional 

amendment to include, in addition to infant formula, to include the products for medical, 

nutritional enteral use. And these are products that are fed to sick children, primarily 

through a tube, and are a sole source of nutrition. And we felt this was compatible with

our thinking about the infant formula because the person cannot choose what food they 

get to eat. And, these are, there is no chance that these materials would be abused by 

anyone else, because they have medical labels on them, and therefore can only be used 

under care of a physician and for medical use. And we feel that those people should have 

the opportunity to have access to organic food with a complete nutritional profile. So, we 

have added that to the motions for both choline and inositol. 

Now I do want to clarify one other point that came up yesterday, and that was why the 

FDA would mandate it for non-milk based infant formula, but not for milk-based infant 

formula. And the people from the formula group that spoke yesterday clarified this for 

me after the meeting was over. The FDA has a number of things that, for them to review 

to put on their approved list or mandated list for infant formula. And, they are a little bit 

behind in their regulation writing. Much as the Department sometimes gets behind, they 

have to go through similar types of loophole or, you know, stuff, red tape, I guess you 

would call it. And so, they see this as something that is widely in use and since 1988 or, 

and again in 1998 or 2000, people have urged them to put this, as well as selenium and 

some other nutrients onto the list. And they have every intention to, but they have not 

gotten to it, yet.

So, I think that we are on very safe ground here in recommending it for all infant 

formula, which is also much clearer to consumers than trying to distinguish between 

milk-based and non-milk-based. So, I put the motion on the table. We do them one at a 

time? 

John Foster: Yes, please. 

Zea Sonnabend: Okay. The motion on the table to classify that choline chloride, CAS number 

67-48-1, and choline bitartrate, CAS number 87-67-2 are synthetic. 
Meeting Of The National Organic Standards Board

May 25, 2012

24

John Foster: Is there, is there a second?

Unknown Female: Second.

Barry Flamm: It has been moved and seconded, to classify choline, both, both the CAS numbers, 

as synthetic. Is there discussion on the motion? 

John Foster: Nick. Nick?

Barry Flamm: John, do you want to take over? 

John Foster: You bet. Go for it, Nick. 

Nick Maravell: Zea, two points. Do we, in the annotation there, normally put C-A-S and a hash 

mark before the numbers or do we just leave that out? That is just a minor point. And...

Go on.

Zea Sonnabend: We have not started really using CAS numbers in the actual listings until very 

recently, but, this was definitely a cause for concern, that things were not precise enough 

in their listing. So, I do not know what the exact precise format is. 

Nick Maravell: Well, to the, to the layperson, it might be helpful to have a CAS number, at least 

C-A-S.

Zea Sonnabend: To say C-A-S?

Nick Maravell: It might be helpful. 

Zea Sonnabend: Okay.

Nick Maravell: Because, other, yeah, it might be. 

Zea Sonnabend: Okay. Does the Department think it makes a difference? Yes? Okay.

Lisa Brines: For consistency, with the way it is represented for other substances on the National 

List, yeah, we would in-, we suggest including the acronym CAS and then the number 

sign. 

Zea Sonnabend: So then we will add C-A-S before the numbers in all the motions.

Nick Maravell: And then, Zea, my, my second question is concerning the clarification on the 

milk-based infant formula and the action, if we can call that, from FDA. You are 

indicating that there is a high likelihood that this will be listed in the future as a required 

supplement in milk-based infant formula, the addition of the choline. Is that correct? 

Zea Sonnabend: Yes, absolutely. 

Comment [JMS9]: 02:15:00
Meeting Of The National Organic Standards Board

May 25, 2012

25

Nick Maravell: If, has, you, has FDA gone through any part of its process towards that? In other 

words, how do we know that indeed, yes, that is likely to happen? I, I understand the 

industry is prepared to do it and is doing it now, to some extent, et cetera, et cetera. But, 

is it, is there something that FDA has done to date or indicated? 

Zea Sonnabend: The FDA is not very transparent in their working, so I cannot answer that 

question. 

Nick Maravell: You cannot. Okay. Thank you. 

John Foster: More questions, discussion? Jay.

Jay Feldman: Are we talking about the synthetic/non-synthetic motion, is that what we are on? 

John Foster: That is correct.

Jay Feldman: I believe the motion should be structured as a motion, move that choline as a nonsynthetic, and that we vote on it being non-synthetic, and we can then determine it, we 

can vote that down. I believe it is...

Zea Sonnabend: [Inaudible]

Jay Feldman: I know. But, I believe our motions, I mean, I would like to check with the Program

on this, but I believe our motions are on synthetic/non-synthetic questions are written to 

the non-synthetic perspective. 

John Foster: Would the Program like to clarify? Or help us understand? 

Melissa Bailey: Just give us a minute here to double check.

John Foster: You bet, you bet.

Lisa Brines: Thank you for your patience. 

John Foster: That is fine, that is fine, take, take what you need.

Lisa Brines: It does not appear to be directly stated in the Policy Manual that classification 

motions for handling materials would always be structured in the affirmative in the same 

way that listing motions are. Based on, I mean, the classify, taking a classification vote

first is a fairly new practice that was reinstituted by the Board after a break of some 

period of time. But, our current recollection and understanding is that it would be 

appropriate to make this particular motion to classify this material as synthetic and take 

the vote on that basis. 
Meeting Of The National Organic Standards Board

May 25, 2012

26

John Foster: Just, just for clarification. Leave it the way it is. Leave it the way it was presented 

just now.

Lisa Brines: That is under, our understanding, the way it would work. 

John Foster: Okay, excellent. Thank you. And thanks for checking that out in short under, in 

short order under public scrutiny, I appreciate that. Okay.

Jay Feldman: I would just like to get something on the record. 

John Foster: Yes, Jay, go ahead.

Jay Feldman: I would just wanted to get something on the record regarding this. I had, I had

advocated that we have a discussion document on synthetic/non-synthetic to resolve these 

sorts of issues. What we are doing by voting on a synthetic motion is recruit, we are 

creating a higher standard, a higher burden on the Board to deem things synthetic, 

whereas the, the Act and Law is structured in just the reverse. That is, the higher burden, 

the higher burden should be to those who are seeking to find that a material... Well, the, 

the idea is that we re-, we, the default should be that we review materials, and put them 

on the National List, unless there is a finding of synthetic. And, it should not be difficult. 

The burden should not be high to reach that finding of synthetic.

And, as, as we put out in the discussion document, that did not make it to this meeting, 

what we are doing here is creating a higher burden on the Board to review things for the 

National List, by structuring motions in this manner. It should not be difficult to review, 

to put things on the National List, because that provides a fail-safe for us to be able to 

evaluate them fully, according to our checklist and the criteria that is in the statute. What 

we want to do is, is err on the side of caution, and therefore make it less difficult to 

review things under the standards of the statute. 

In this situation, although this is not a controversial one, I recognize that, but, as a matter 

of process, I think the burden should be shifted here, and I hope we can work this out 

down, down the road with the Program. I, I assume we can. But, that we have some 

clarity on, on these points. Because, at the end of the day, if this is controversial, then it is 

much more difficult to subject this chemical to review under the National List process

when we establish the motion in this fashion. That is all.

John Foster: Duly noted. Alright. Any other additional discussions? Seeing none, I think we can 

proceed. 

Barry Flamm: Is there any conflict of interest on this material? Jay and Zea, I do not know if you 

heard the request or not. Is there a con-, do you have a conflict of interest?

Zea Sonnabend: I work for a certifier that may or may not make things with this ingredient, 

certified.
Meeting Of The National Organic Standards Board

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27

Melissa Bailey: You do not need to recuse yourself. 

Barry Flamm: Anyone else wants to declare a conflict of interest or ...? Joe.

Joe Dickson: I work for a retail chain of stores that sells many products which contain this and 

other supplementary ingredients. 

Barry Flamm: Thanks you.

Melissa Bailey: You do not need to recuse yourself, Joe. 

Joe Dickson: Thank you, Melissa. 

Barry Flamm: Anyone else would like to make a declaration? Hearing none, we can proceed 

with the voting. John, would you begin the voting? 

John Foster: Yes. 

The Entire NOSB Board: Yes. Yes. Yes. Yes, sir. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes.

Barry Flamm: Does that complete? The chair votes yes. 

Zea Sonnabend: I am waiting for the ...

Barry Flamm: 15, 15 yeses, zero noes. The motion passes. 

Zea Sonnabend: Thank you, Barry. Our next motion is to add choline, choline chloride, with a 

CAS number 67-48-1, and choline bitrar-, bitartrate, CAS number 87-67-2 to the 

National List 205.605(b) for use in infant formula and medical nutritional enteral 

products labeled organic or made with organic specified ingredients or food groups. 

Barry Flamm: Is there a second?

Unknown Female: Second. 

Barry Flamm: It has been moved and seconded. John, would you lead the discussion? 

John Foster: You bet. Is there any discussion on this? I have Jean.

Jean Richardson: I will be voting in favor of this motion but with considerable reluctance to see 

anything, any synthetic things being added to infant formula, the only reason being is that 

it is going to be, it is required by the FDA for soy right, infant formula right now and will 

be for the milk-based ones in the not too distant future.

John Foster: Thank you. Additional? Colehour.
Meeting Of The National Organic Standards Board

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28

Colehour Bondera: Yes, thank you. Based upon my understanding and review and in addition, 

even the revisions to the motions as was presented previously by Zea, I just wanted to let 

people know that I will be voting against this motion unless the words organic or are str-, 

struck from the motion. Thank you. 

John Foster: Thank you. Other ...? Jay.

Jay Feldman: Thank you. Thank the, I would like to thank the Committee for its work on this. I 

know these are difficult petitions. I, you know, the law was written in such a way as to 

allow those requirements from FDA to be allowed under the organic statue. And that 

made, that makes sense to me. Unfortunately, FDA has been slow on updating its

standards over the years. We heard testimony on that. And, we know from other 

discussions, previous discussions, that that has been the case.

At the same time, I think there has been some degree of acceptance of certain nutrients 

and vitamins that are deemed recommended. Even though FDA has not mandated them 

or required them. And so, I would like to put into the record a citation here on this point, 

which comes out of the Pediatric Nutrition Handbook second edition by the American 

Academy of Pediatrics. The second edition, I do not have a date, unfortunately. Appendix 

1, recommended ranges of nutrients in formulas. And, this is, this is something that I 

think we need to consider as a Board when we look at these things. And, it includes on 

the list, choline at seven milligrams per 100 kilogram or cuh-, what is k, k-c-a-l, nutrient 

and inositol at four. Okay, and the date of the publication is 1985, American Academy of 

Pediatrics. 1985? 

Unknown Female: 85? [Laugh]

Jay Feldman: Okay. Okay, so just to put that on the record, I am, obviously, I am concerned 

about fortification in organic, especially with synthetics. I, well, with synthetics, that is, I 

should say. So, fortification of, of synthetics, I think I, I really want us to consider as a 

problem area that we should not take lightly, and we should, we should look at this very 

carefully when we are talking about recommended nutrients and accepted nutrients that 

are advanced by the American Academy of Pediatrics and others. I think we need, that is 

a different, different discussion. Okay.

Now, having said that, of course, we come at, we, we have to face this discussion a little 

bit differently than I think the conventional industry does, in the sense that we, we should 

be looking at both whether there are non-synthetic versions of these things, number one, 

and we should be, be aware of whether there are hazards associated with the production 

of these, these nutrients that we view as recommended and necessary or essential to some 

degree. 

And, your TR, the guys, the one you guys looked at in the Handling Committee, on the 

first point, on the issue of non-synthetic or natural sources did not do, I do not know how 

you felt about this, I wanted to hear from you guys. I, I found it very unsatisfactory and I 

want to read this to you. This is a question: provide a list of non-synthetic or natural 

Comment [JMS10]: 02:30:00
Meeting Of The National Organic Standards Board

May 25, 2012

29

sources of the petition substance, which is a checklist question for review. Choline can be 

supplemented through diet by addition of organic liver, eggs, wheat germ and other foods 

high in natural choline. Breast milk is another natural form of choline for infants whose 

mothers are not able to breast-feed. While choline is a natural non-synthetic substance 

found in many foods, some people do not synthesize or consume enough choline in their 

diet. That line is choline 2008. 

It does not appear that there are natural or non-synthetic sources of the petition 

substances, choline chloride and choline bitartrate. One natural source of choline that 

may be used as a food additive in place of synthetic choline salts is unbleached lecithin 

which contains – can you pronounce that for me? – phosphatidylcholine. Yeah, that one. 

Lecithin is defined by FDA as a naturally occurring mixture of phosphilatides 

[phosphatides] of choline, etha-, whatever these are, and inositol, with smaller amounts 

of other lipids. It is isolated as a gum following hydration of solvent-extracted soy, 

safflower, or corn oil. 

So, my focus here, John, is this issue of whether there actually is a non-synthetic 

alternative. And I, for one, I know we have had this discussion and I, I know you are in 

agreement, that we really get a good fix on whether we have a non-synthetic alternative. 

And, this, this equivocal language is really, I just want to raise this as a, as a problem. I, I 

really feel, especially on petition substances, we are not, you know, when we have this 

discussion on Sunset, I know people's reluctance to move something off with some shaky 

discussion as to whether there really is a non-synthetic alternative. I understand that. But, 

here we are adding something to the List. And so, I think we need to really have, and you 

may have an answer to this. We really have a good fix on the, the non-syn-, nonsynthetic. So, I, I hope Zea will address that. 

The, the other point on extractants is, and this speaks to the issue that the Committee, I 

think, wisely identified. And that is this made, using this made with category. This issue 

of the extractant, and again, it is ironic how these conversations sort of blend together. 

But, the TI, the TER said the organic component 1,4-dioxane has been classified as 

possibly carcinogenic to humans by the World Health Organization’s International 

Agency for Research on Cancer. It may be present in choline salts, due to the use of 

ethylene oxide in the manufacturing process. And then recognize that 1,4-dioxane not 

only is there a huge consumer movement on the toxics, on the industrial toxic sites to 

remove 1,4-dioxane from cleaning products and detergents, but here, even this chemical 

is on the Proposition 65 list at, in California. 

So, I do not think there is any real question that this is a hazardous carcinogenic 

extractant or ingredient or mix, mixed, I do not know what the technical term would be, 

but it is used in the manufacture of this material. And so, that puts it into a totally 

different class, in my view, I mean, as allowed in organic. So, I just put those two issues 

on the table and I appreciate again the Committee's work on this. 

John Foster: Discussion? Zea.
Meeting Of The National Organic Standards Board

May 25, 2012

30

Zea Sonnabend: Okay, the part of the TAP review about alternatives, we did look into. And, I am 

not sure if I can find it that easily, but, found at least one research paper from the 70s 

about how it was not technically feasible to get enough lecithin into a formula that would 

provide a substan-, enough choline. And not only that, but since the lecithin is derived 

from soy and there is considerable controversy about whether soy is a good thing to feed 

your baby or not, it just really seemed to leave that alone and it was not a viable 

alternative. And, in the desire for precaution, this is why we only recommended it for 

infant formulas, where it was mandated by law and for these medical products, where 

they don't have alternative nutritional sources. 

John Foster: Thank you. Let, Nick and then Harold I believe.

Nick Maravell: Yes, I would, I would like some clarification. Maybe the Program can provide

this just on the record. Let us just suppose we take no action, whatsoever, with regard to 

choline, and it is required by FDA under certain circumstances. Would those products be 

permitted to be used by default or some other mechanism in products labeled as organic 

that are infant formula? 

John Foster: We will wait to see if the Program wants to weigh in on this.

Crowd: [Whispering]

Melissa Bailey: Okay. Oh, John has walked away from the table. [Laughing] 

Crowd: [Laughing]

John Foster: I just had, I just had to stretch my legs for a minute. Thank you. Thank you for the, 

your indulgence on that. Yes? 

Melissa Bailey: Okay, so as the Board knows, we are, the Program is currently engaged in a rule 

making, specific to the listing for nutrient, vitamins and minerals on the National List at

605(b). The proposed annotation in that rule making would cover the use of choline in

non-milk-based infant formulas, should it be finalized. But, it would not cover the use of 

choline in milk-based infant formula, hence why you have this petition on the table. 

John Foster: Thank you. Alright, Harold.

Harold Austin: Yeah, this, either to, back to Jay or to Zea, either one. On the appendix that Jay, 

Jay was quoting from and the numbers there, how does that match up with what the FDA

mandate is on that?

Zea Sonnabend: Actually, address that to Emily, because I believe those numbers are in the 

docket that you just referred to, in the rule making, the numbers. 

John Foster: Em-, Emily? Thank you. 
Meeting Of The National Organic Standards Board

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31

Emily Brown-Rosen: If you give me a minute, I can pull that up. But, you are talking about the, 

the requirements, guarantees for infant formula? Yeah, I will, I will get that.

Zea Sonnabend: The required levels for infant formula. I think there was a chart in the docket.

Emily Brown-Rosen: We did, yeah, we did. It is from the, the FDA rule on infant formula 

requirements, but I will, I will get that to you in a second. 

John Foster: Thank you. Additional questions? Looks like last call. Alright. Seeing no more, we 

can move to voting. 

Barry Flamm: Would the, would you restate the motion for clarity of the, the Board? 

Zea Sonnabend: The first listing motion is to add choline chloride, CAS number 67-48-1, and 

choline bitartrate, CAS number 87-67-2 to the National List 205.605(b) for use in infant 

formula and medical nutritional enteral products labeled organic or made with organic, 

specified ingredients or food groups. 

Barry Flamm: And there was a second, so conflict of interest? 

Jay Feldman: Point of order. What, did we, maybe I misunderstood what Colehour was 

suggesting. Were you, was he suggesting a, an amendment to this or, or not? I, I was not 

clear on that. 

Colehour Bondera: Yes, I, I am requesting the removal of the words “organic or” from this 

motion.

Jay Feldman: Okay.

Unknown Male: Are you [inaudible].

Unknown Male: So it, it just, excuse me, so it just reads “labeled made with organic”. 

Zea Sonnabend: The maker of the motion rejects that request. You will have to propose it as a 

second motion if this fails.

Barry Flamm: Colehour, do you...?

John Foster: So...

Colehour Bondera: [Inaudible]. Thank you.

Barry Flamm: Okay, we will proceed with the voting. Who is next? Joe, would you begin the 

voting?

Joe Dickson: Yes. 
Meeting Of The National Organic Standards Board

May 25, 2012

32

The Entire NOSB Board: Yes. Yes. Yes, sir. Yes. No. Yes. No. No. Yes. No. Yes. Yes. Yes.

Barry Flamm: Yes. The chair votes yes. The vote is 11 yeses, 4 noes, the motion passes. 

Zea Sonnabend: Thank you, the second listing motion is to add choline chloride, CAS number 

67-48-1, and choline bitartrate, CAS number 87-67-2 to the National List 205.605(b), for

use only in agricultural products other than infant formula and medical nutritional enteral 

products labeled made with organic, specific, specified ingredients or food groups, and 

prohibited in agricultural products labeled organic. Now I, oh, I guess we need a second 

before discussion. 

Unknown Female: Second. 

Zea Sonnabend: Okay. 

Barry Flamm: Moving [inaudible]. 

Zea Sonnabend: I did not know if we needed the last part or not, to clearly state prohibited for 

the other. But, I put it in. And then I would also like to ask the Department for 

clarification on what happens to, this is a unusual one, but a precedent for a lot of other 

ones coming up. There are products already out there in the marketplace using an organic 

label with choline fortification. And, if this, if they are not added to the National List, will 

they get a grace period to use up, to re-label and reformulate? Or, do we have to put that 

in the motion? 

John Foster: From the Program?

Miles McEvoy: Yeah, you are asking a general question about an existing rule making action 

that we are conducting on nutrient, vitamins and minerals in terms of the phase out. And, 

and in the proposed rule, we asked for comments, specifically about that, and we will, we 

will be able to address that in the final rule on, on nutrient, vitamins and minerals, in 

terms of the phase out.

Zea Sonnabend: Except, the specific part of that question is, do we need to put something in the 

motion right now, or it would not happen? 

Miles McEvoy: What you are working on is a petition to add something to the National List, so 

there is no phase out involved in adding something to the National List. 

Zea Sonnabend: Okay, thank you. 

John Foster: Additional ...

Barry Flamm: I will turn it over to John for guide discussion. 
Meeting Of The National Organic Standards Board

May 25, 2012

33

John Foster: Additional discussion? Jay.

Jay Feldman: Thank you. Okay, so now we are talking about allowing a substance for which 

there are other sources of choline, right? To a made with labeled product. Not, well, made 

with product. And, what, why do you think we need to do that, if there are other sources 

that, that are not, I mean, in the case of infants, certainly we are talking about a, as I 

understood it, an essential ingredient at a certain level in a product. That seems to have 

some degree of agreement around, although, I guess there is some, still some question as 

to whether the recommended ranges of nutrie-, nutrients in infant formulas is, is a 

appropriate citation. But, regardless of that, now we are, we are moving off of something 

that is in this gray area of recommended, required, to something that clearly does not

have essentiality but manufacturers would like to have. Could you just explain a little bit 

more of the thinking of the Committee on that point?

Zea Sonnabend: The thinking of the Committee on this was allowing it in adult foods in the 

“made with organic” category would a, allow such foods to highlight the fact they are 

fortified, while at the same time limiting the number of non-essential synthetics in 

organic processing. It was felt that a large number of consumers buy fortified foods, and 

a large number of manufacturers make them. And therefore, that would highlight the fact 

that these materials were synthetics in the foods that they were buying by putting it in the 

“made with organic” category. Now, personally, I would much rather, I would allow it in 

the “made with organic” category if it could have on the ingredient panel “synthetic 

choline”, but I do not think that is within our purview to mandate. And I personally will 

not be voting for this motion. But, we put it forward from a Committee for people who 

wish to have that choice.

John Foster: Okay, Jay and...

Jay Feldman: Yeah, I am...

John Foster: Hold on just a second, I am going to, I have got a response to your question. But, I

am going to wait until everyone else is done, so.

Jay Feldman: Again, just to reiterate, quickly, I am worried about this fortification issue as it, as 

it relates to synthetics. So, I, I almost feel like we, as a Board, need a more lengthy and 

detailed conversation on, on this, and how it fits within the structure of the statute. And, 

the intent associated with the allowance of essential materials, essential synthetic 

materials in organic production, handling, processing. So, I think until we have that 

discussion and get clarity around the issue of synthetic fortification, I do not feel 

comfortable. I think it is outside the category of allowance in our statute. And, and we 

should really look for natural forms of these materials, if they are available. And, and

encourage manufacturers to, to go down that road. Thank you. 

John Foster: Any other discussion, thoughts? Alright, hearing none, I told you that I would save 

mine for the last. So one of the schools of thought was that, this relatively small amount 

of materials like this, encourage a broader use of a, a wide variety of organic ingredients

Comment [JMS11]: 02:45:00
Meeting Of The National Organic Standards Board

May 25, 2012

34

from a handler's standpoint. Where customers need to be, you know, attracted to 

products, that is a, that is a worthwhile consideration. So, I just wanted to get that out 

there. That is part of the thought is that it, it encourages the use of additional organic 

ingredients in the marketplace. Alright, now we will do last call. 

Barry Flamm: I believe that is, complete the discussion.

John Foster: Completes the discussion, ready to vote. 

Barry Flamm: We are ready to vote. I believe, believe we did the conflict of interest earlier. So, 

proceed with Jean please. 

Jean Richardson: No. 

The Entire NOSB Board: Yes. No, sir. Yes. No. No. No. No. No. No. No. No. Yes. No. 

Barry Flamm: The chair votes no. Three yes, 12 no, the motion fails. We will take a 15 minute 

break at this time.

[BREAK] 

Barry Flamm: Board members, please take your chair. 

Nick Maravell: Barry, I think that there is, there is, I am wondering if we can reintroduce the 

[inaudible] so maybe we can talk about that after [inaudible].

Barry Flamm: I do not think we can [inaudible] the vote was taken.

Nick Maravell: Well, I voted for it [inaudible] in fact I thought, thought we were going to 

[inaudible].

Barry Flamm: But I, we have got to proceed.

Unknown Male: Are you unplugging yourself, sir?

Barry Flamm: The Board is back in session. John, would you like to proceed? 

John Foster: Yes, Barry, thank you. I would like to proceed with the petition for gibberellic acid.

And if I am not mistaken, I believe Zea was point person on that. Zea, would you be so 

kind? Thank you. 

Zea Sonnabend: Okay. Thank you. Before we put forward a motion on this one, what we decided 

to do but did not actually pass in Committee was to adopt the language suggested by 

OMRI. Our original motion was “gibberellic acid for postharvest banana use only” and 

the addition by OMRI suggested was “may only be formulated with 2004 EPA List 4 

inert ingredients”. And that is the motion, although Miles is not here, but here he comes. 

Comment [JMS12]: 02:49:10

Comment [JMS13]: 03:10:28
Meeting Of The National Organic Standards Board

May 25, 2012

35

But maybe Emily can answer this whether this is actually an appropriate form or whether, 

like in 205.601, inerts needs to be a separate listing. So inerts used with the products in 

there. Is this an appropriate listing?

John Foster: Program?

Emily Brown-Rosen: Yes, sorry for the delay there, but, yes, we think that you should put it in 

the annotation if you want to include a reference to inerts. We do not think it is necessary 

to say 2004. It should just say EPA List 4 to be consistent with the rest of the National 

List. 

Zea Sonnabend: Okay. So, would anyone on the Committee like to make that motion, or anyone 

for that matter? To put gibberellic acid on the National List, 205.605(a), for postharvest 

banana use only, may only be formulated with EPA List 4 inert ingredients.

Jean Richardson: For the motion. So moved.

Barry Flamm: Is there a second to the motion?

Zea Sonnabend: Okay.

Harold Austin: Second. 

Zea Sonnabend: Okay, Jean moved and Harold seconded. 

Barry Flamm: Is, call for point of order. 

Unknown Male: Does it need to be classified first? 

Zea Sonnabend: Well, it has previously been classified for crops as non-synthetic, so my

understanding is it does not need to be reclassified. Is there discussion? Should I call for 

discussion or you?

Barry Flamm: No. John, I will pass the discussion to you.

John Foster: You bet. Thank you, Barry. Yeah, any discussion on the motion? Yes, Jay. 

Jay Feldman: Having worked on inerts and as you all know, we are moving ahead with an inerts 

policy. It is wholly, I believe, inappropriate to add inerts to products at this stage that are 

not evaluated independently. That would also be, I believe, unfair to other manufacturers 

that have, have been waiting in the queue for a review of their inerts which are also on

these lists, List 4, a or b. So I, in an interest, in the interest of fairness, and given the fact 

that we do not have a good hazard evaluation of the full, full formulation that we are 

talking about here, I cannot support this. Sorry, Louise. 

John Foster: Thank you. Thank you, Jay. Conditional comments, please. Zea.

Comment [JMS14]: 03:15:00
Meeting Of The National Organic Standards Board

May 25, 2012

36

Zea Sonnabend: Okay. In response to Jay, this is not adding new products to the list because it is 

the same formulation of gibb, formulations multiple that are already in use for crops.

Jay Feldman: Adding new, new uses. I misspoke.

Zea Sonnabend: New uses. Yes. Okay. And, where do I want to go? Oh. This is, at this point, not 

the Committee opinion, but is my personal opinion. As a scientist, I like to make the 

distinction of what is opinion from fact. I struggled with this one a great deal, because I 

do not think there is really harm in the product itself, gibb, in gibberellic acid as 

formulated for uses. However, the mandate of putting things on the list in handling has, 

you know, a different set of criteria. And, we ask, you know, we asked for input on one 

aspect of it, which was the call on whether cultural practices could control the disease 

Black Sigatoka. We did get some input that that was, that could happen. But, we also got 

some input that, and this was true from the original petition, that the concern over Black 

Sigatoka was only one of the concerns. 

And the additional concern was being able to ship bananas for long distances without 

have them, having them ripen prematurely. The distances that, and the length of time that 

was presented to us in public comment yesterday was, I believe, 22 to 30 days. This, to 

me, was, is not one of the criteria that we evaluate things for handling. And, much as I 

hate to do it because I have total sympathy for small farmers, I believe I have decided to 

vote against this material because it has, its use has not proven to be essential to me. I 

cannot get beyond the fact that yes, we have plenty of bananas, not yes we have no 

bananas. [Laughing] 

Crowd: [Laughing]

Zea Sonnabend: I am corny, that is why I am called Zea. 

John Foster: That was awesome twice over. Wow. Well done. Well done. Additional, additional 

comment? I will save mine for after everyone else is done. Additional comments? 

Alright, maybe we are done. 

I, I will be voting for this. I think, I think the arguments around quantities are I do not 

know, I know there is a lot of organic bananas, but I would like to see more and it seems

to me that this will help that. So after particularly seeing the photograph of delicately 

putting paint, applying this material with a paint brush to the tops of the bunches, I cannot 

imagine a more precise and strategic use of a material than that. In fact, I cannot think of 

an, anyone in agriculture or postharvest handling that is that precise and that controlled. 

So, from that point of view, you really, you, a, a producer would not be doing that unless 

they felt it was absolutely necessary. So, I am, that is, that is all I wanted to say. Oh, 

sorry, Harold.

Harold Austin: Sorry, I know you wanted to go last, but...
Meeting Of The National Organic Standards Board

May 25, 2012

37

John Foster: No. I just did not want to crowd anyone out. That is all.

Harold Austin: Well, I think the other thing too to take a look at is that gibberellic acid is also a

natural, naturally occurring substance within the plant itself. So they are just augmenting 

that process once the, once the bunches have been removed to stabilize the, the plant 

from over ripening. I think the other thing to point out is that it, it does, it would help 

those small growers to be able to deliver a better quality product with less rejections, thus 

giving them a more sustainable presence in the market. So, I think when we look at that 

part of it, I think there is value in, in at least considering this as an option to, to include 

for them as a, as another tool to put in their toolbox. 

John Foster: Thank you, Harold. Additional comments? Okay. Seeing none, we can proceed with 

vote.

Barry Flamm: Is there a conflict of interest? Zea.

Zea Sonnabend: I work for a certifier who I do not think certifies bananas, but I am not sure. So, 

I guess I need the ruling. 

Miles McEvoy: You do not need to recuse yourself. 

Barry Flamm: Any other? All right, we can proceed to the voting, beginning with Harold.

Harold Austin: Yes. 

The Entire NOSB Board: Yes, sir. Yes. No. No. No. No. No. No. No. Yes. Yes. No. No.

Barry Flamm: The chair votes no. What is the count? Five yes, 10 noes, the motion fails. What is 

next, John? 

John Foster: The next material is the last material on the Handling Committee’s agenda. And that 

is inositol. Michelle, I believe, could you pull up the most recent version, please? Alright, 

and if we could scroll to the last, there we go, right where the red ink is there. Just before 

a motion, very quickly, we did, you will see on the next page in a second, we made a, a

slight amendment, similar to choline. The discussions around this were similar to 

discussions we had around choline. So I will not go into that. We did add CAS numbers, 

and we did made another similar amendment that you will see in a second here. And this 

is paragraph that is just speaking to that point. So if we could go one more page. I guess 

one more page. There, thank you. So, I, with that, I would like to move that inositol as 

petitioned, CAS numbers 87-89-8, myo-inositol, and 6917-35-7, nonspecific isomer, is 

synthetic. Do I have a second? 

Unknown Male: Second.

Unknown Male: Second.
Meeting Of The National Organic Standards Board

May 25, 2012

38

Barry Flamm: It has been moved and seconded to add inositol to the, to the List. John, you want 

to lead the discussion? 

John Foster: Sure. Is there any discussion? Yes, sir, Colehour.

Colehour Bondera: I am sorry. I am sorry, we are just talking synthetic/non-synthetic, is that 

accurate?

John Foster: That is correct. This is for classification.

Colehour Bondera: I apologize. I do not, I do not, yes, I apologize, I withdrawal.

John Foster: Okay. No problem. Alright. Additional discussion? Seeing none, Barry, we can 

proceed to vote. 

Barry Flamm: Okay. We are voting on synthetic/non-synthetic...

John Foster: This is classification. 

Barry Flamm: The motion is of this material. We are voting on declaring this a synthetic, 

correct?

John Foster: Correct. 

Barry Flamm: Okay. Zea? Is there a con, a conflict of interest on this, this material? Zea are 

you...? 

Zea Sonnabend: I work for a certifier that way or may not certify products with this in it.

Miles McEvoy: No recusal necessary. [Laugh]

Barry Flamm: Joe.

Zea Sonnabend: Gets old, huh?

Joe Dickson: I, I work for a chain of retail stores that sells many products that contain this 

ingredient. 

Miles McEvoy: You do not need to recuse yourself. 

Barry Flamm: Anyone else? Alright, we will proceed with the voting, starting with Mac. 

Mac Stone: Yes, sir. 

The Entire NOSB Board: Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes. Yes.
Meeting Of The National Organic Standards Board

May 25, 2012

39

Barry Flamm: Chair votes yes. 15 yeses, zero noes, the motion passes to classify this as a 

synthetic substance. We will proceed. 

John Foster: Yes.

Barry Flamm: John, do you have a motion? 

John Foster: Yes, sir. Michelle, I wonder if we could have that up on the screen again, please.

Thank you. Next motion is a listing motion. I move to add inositol, CAS numbers 87-89-

8, myo-inositol, and 6917-35-7, non-specific, non-specific isomer to the National List, 

205.605(b) for use in infant formula and medical nutritional enteral products labeled 

organic or made with organic, parenthetically specified ingredients or food groups. Do I 

have a second? 

Unknown Male: I will second. 

John Foster: Discussion?

Barry Flamm: Do we have a second? Oh, okay. It has been moved and seconded to list inos-, 

inositol on the, on the List as described on the screen now. John, you want to take over 

the discussion? 

John Foster: You bet. Do we have any discussions on this point? Colehour.

Colehour Bandera: Yes, thank you, John. I feel like I am going to be repeating to some degree 

what I said about choline, but more specifically as a father who has two children and 

understands the issue of infant formulas. But, also as a consumer who looks very 

carefully. And I will throw in the fact that we are all are consumers. And as a consumer 

who looks very carefully at products to know what I am getting and to look for accurate 

representation, I hereby request that the motion strike the words “organic or”, and then it 

would have my support. Thank you. 

John Foster: A point of order. Is this a friendly amendment? Well, I mean, well, proposed 

amendment.

Crowd: [Laughing] 

Colehour Bondera: You, you suggest [inaudible] amendment?

John Foster: Depends on your point of view, I suppose. As with choline, I will, I will reject that.

Colehour Bondera: I hereby thank you for your friendly consideration.

Crowd: [Laughing] 

John Foster: Jay.
Meeting Of The National Organic Standards Board

May 25, 2012

40

Jay Feldman: But I would like to second the motion, in a very friendly way of course. 

John Foster: Oh, I see you are smiling. Of course, that would be mean to be necessary. And then 

I would actually friendly reject that. 

Jay Feldman: I do not think... I think we can vote. 

John Foster: Oh, no, you are right, you are right. We have to, I am sorry, my, my mistake. We 

need to have discussion on that point. 

Jay Feldman: Right.

John Foster: Yes. Thank you. Thank you for correcting me. Jay? 

Jay Feldman: Okay, so a lot of this is similar, as you pointed out, to choline. So just want to 

make sure again that we recognize the Pediatric Nutrition Handbook, and the apparent 

recognition of, of the essentiality of inostitrol [inositol] at a certain level. They, they have 

it here in milligrams per kilogram at 4.0. Which, for me, in terms of fortification, or I 

would view this more as nutrient addition, a very distinct discussion from fortification of, 

with synthetics outside of that context of required for, especially for infants. 

Having said that, I, the reason I like Colehour's approach on this is, and I wish we had 

considered it more thoroughly with the choline, it because it, it is a good compromise. It, 

it allows for product differentiation in the market, which we are really trying to get at. 

And I really appreciate what you are const-, constantly reminding of us, of us here, John, 

that we do want to, you know, increase the demand for organic, and thereby increase

acreage, et cetera, et cetera, and that consumers we know are, parents especially, are 

looking for certain things and products that their pediatricians tell them to look for, et 

cetera.

On the flipside, of course, I feel we in the organic community have an obligation to 

educate consumers with, with our, you know, with, with the best information we have at, 

have on the subject. So, the reason this is a good compromise is because, and I remember 

this as you all probably do from the early days, you know, a lot more products with the 

“made with” before we were putting all this stuff on the National List. “Made with” was 

a category that did differentiate, and still does. And there are many manufacturers out 

there that use it very successfully and profitably. And yet, it, it enables us to put a 

synthetic in that I would typically vote against. 

But, because of these nutritional requirements, I feel compelled to support, but not in the, 

not under the label. See? That is a distinction. Because, here we are putting, we are 

adding a form, a synthetic form. Again, we talked about this in the past. Hopefully, part 

of what we are doing here as a Board is we are creating incentives for manufacturers 

develop natural, to develop natural forms of these synthetics. And so, I think by putting 

these synthetics on, just jumping in whole hog under the label that we are not, we are not

Comment [JMS15]: 03:30:00
Meeting Of The National Organic Standards Board

May 25, 2012

41

doing that. We are cutting off the incentive to develop the alternative. So, thank you, 

Colehour, for that amendment, and I hope others will support it. 

John Foster: Sorry, is there more discussion on the, I do not even know what we call that, the

amendment? 

Barry Flamm: We have a... Who, who seconded the amendment? Jay?

John Foster: Jay seconded. 

Barry Flamm: Okay.

John Foster: Hum-mmm. More discussion on the amendment? Okay, seeing none, I believe we 

can proceed to vote on the amendment.

Barry Flamm: So we are voting on amendment to the motion. And the amendment... If the 

maker of the motion would re-state his amendment for clar-, so that the Board is clear 

what we are voting on. 

Colehour Bondera: Yes, thank you. The amendment is to strike the words, where it reads “infant 

formula labeled organic or made with organic” to strike the words “organic or”. That is 

the amendment. 

Barry Flamm: So, it would read just “made with organic”?

Colehour Bondera: That is correct. 

Barry Flamm: Alright.

Unknown Male: Mr. Chair. [Inaudible] has a question.

Barry Flamm: Okay. There is the question.

Nick Maravell: Are we, are we, can we, can we, is there an opportunity for discussion on this? 

John Foster: We, I, I asked for discussion I think. 

Nick Maravell: Oh, yeah, I, I have a question. If this amendment passes, then we would have a 

little bit of lack of parallelism, if you will, between choline and inositol. 

John Foster: That... Correct. 

Nick Maravell: And, I would, I, I guess what I am asking is, if this were to pass, I voted for 

choline as it went through, would it be appropriate to reconsider that vote and give the, 

give the Board the opportunity to consider amending our previous action? 
Meeting Of The National Organic Standards Board

May 25, 2012

42

John Foster: I, I cannot really speak to that.

Nick Maravell: Okay. [Inaudible].

John Foster: It is above my pay grade. 

Nick Maravell: Well, let me ask, would it, would it be in order, maybe appropriate is the wrong 

word, would it be in order to ask for a reconsideration of, of the choline vote to determine 

if any members wanted to re-do? 

John Foster: I, I would need to give that over to the chair. That would be his discretion, or his 

decision. 

Barry Flamm: Let us, we have a tight schedule, so let us proceed with the vote on this 

amendment, and we will, we will consider your ... after the outcome here. 

Nick Maravell: Okay.

Barry Flamm: Wendy will lead off the vote on the amendment. 

Wendy Fulwider: No.

The Entire NOSB Board: Yes. Yes. [Inaudible]. No. Yes. No. Yes. No. No. No. No. No. No. 

Yes, sir. 

Barry Flamm: The chair votes yes. Five yes, 10 no, the amendment fails. We will proceed with 

the, the main motion. 

Lisa Brines: Excuse me, Barry? We had a, we had a different count for that vote. 

Barry Flamm: I am sorry.

Lisa Brines: We had six yes and nine no. 

Barry Flamm: Okay. Alright. Thank you for the correction. Six yeses, nine noes. The motion still 

fails. 

John Foster: All right, we will proceed with the main motion, then. Would you like me to 

restate? 

Barry Flamm: Yes, would you restate the main motion? 

John Foster: Michelle, could you put that up on the screen again or...? Oh, sorry. This is a listing 

motion. I move to, the motion was to, to add inositol, CAS numbers 87-89-8, myoinositol, and 6917-35-7, non-specific isomer, to the National List, 205.605(b) for use in 
Meeting Of The National Organic Standards Board

May 25, 2012

43

infant formula and medical nutritional enteral products labeled organic or make with 

organic, parenthetically specified ingredients or food groups. 

Barry Flamm: Thank you. 

John Foster: We can proceed to vote. 

Barry Flamm: We already have. 

John Foster: Oh.

Barry Flamm: Was there any more discussion, John? 

John Foster: Apparently, Jay. Yep.

Jay Feldman: I am sorry. Yeah, I was just trying to support the motion. I did not, I, I wanted to 

get on the record the concerns that were raised in the TR, just so that it is clear here, that

according to the TR, gibberellic acid, at least that which is made by submerged 

fermentation techniques is quote purified using methanol, acetone, ammonia, ammonia 

salts, and/or ethyl acetate, specific details on recovery and purification processes are 

generally not published but rather kept...

Jean Richardson: Point of order. 

John Foster: Were you talking about gibberellic acid? 

Jay Feldman: Oh, I am sorry. Thank you. I am reading the wrong thing. Yeah. Apologize for 

that. 

John Foster: In, in your favor, you had a lot of people like going with it for a second.

Jay Feldman: No. no.

John Foster: That was very convincing. 

Jay Feldman: I do not know how that. Oh, I see what happened. I am sorry. No. You are right. 

Okay, well, let me, before I get back to, to the issue of synthetics used in its production, I 

wanted to, to address the issue of whether there was, you know, the manufacturing 

processes and what, what we, what we know and do not know about the manufacturing 

processes of, of this and how it is made. I guess my question is, maybe, Zea, you can help 

me with this, my understanding was that there was a process of dilution with water 

boiling and agitating that and whether this, whether in fact when you looked at the 

manufacturing process, that, that there were no ingredients or processes that were, that 

were identified as pot-, as potentially hazardous. I guess that is what I am getting at.

Zea Sonnabend: Can I respond to that? 
Meeting Of The National Organic Standards Board

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44

John Foster: Zea.

Zea Sonnabend: Thank you. I was not the point person in this, so I did not delve into the research 

as much as I did on choline, but my understanding is that it, while it could be made nonsynthetically, it is not in any form that anyone can buy. So, it is not commercially 

available. Although theoretically feasible to ex-, make it from a non-synthetic source. 

Jay Feldman: Yeah. Okay. I do not want to belabor this point, but I wanted to make sure we had

on the record, and I cannot find this now, the, the materials that are actually used in the 

process of making this, and whether in fact, you know, we are, have fully evaluated what 

those materials are. Again, because this is viewed as essential, obviously, this is not a, not 

as, as critical as in other situations. But, it still in my mind goes back to the point of 

whether we should be carrying this under the organic label. But, we have already voted 

on that so, apologies for reading from the wrong script here. 

John Foster: That, that is all right. It has been a long week. Duly noted. Thank you. Additional

discussion? Alright, seeing none, I believe we are ready to proceed to vote. 

Barry Flamm: Thank you, John. Let us see who you got here. We will begin the voting with 

Colehour.

Colehour Bondera: No. 

The Entire NOSB Board: Yes. No. No. Yes. No. Yes. Yes. Yes. Yes. No. Yes. Yes, sir. Yes. 

Barry Flamm: Chair votes yes. 10 yes, five no, the motion passes. John, do we have any...? 

John Foster: Yes, we have one more, what I believe is one more motion to put forward. Could 

we have that up on the screen again, please, the, the pages? Thank you. This is a second 

listing motion. I move to add inositol, CAS numbers 87-89-8, myo-inositol, and 6917-35-

7, non-specific isomer, to the National List, 205.605(b) for use only in agricultural 

products other than infant formula, other than infant formula, and medical nutritional 

enteral products labeled “made with organic, specified ingredients or food groups” and 

prohibited in agricultural products labeled “organic”. Second? Joe?

Barry Flamm: We have a second?

Joe Dickson: I second that. 

John Foster: We have a second. Is there discussion? 

Barry Flamm: For the...

John Foster: Alright. Seeing none, I believe we can proceed to vote. 
Meeting Of The National Organic Standards Board

May 25, 2012

45

Barry Flamm: Okay, we will start the voting with, with Nick. Nick, would you start the voting, 

please? 

Nick Maravell: No. 

The Entire NOSB Board: No. No. Yes. No. No. No. Yes. No. No. Yes. No, sir. Yes. No. 

Barry Flamm: Chair votes no. 

Zea Sonnabend: Could I change my vote to no because I was, thought it was the previous vote. 

Barry Flamm: Without objection. What was the count? 

Unknown Female: 12 no.

Barry Flamm: The vote is three yes, 12 no, the motion fails. 

John Foster: Mr. Chair, it is with some happiness I report that is the last of the voting items for 

the Handling Committee. 

Barry Flamm: Whoopee. 

John Foster: Oh, my God. 

Barry Flamm: Next, next on the agenda is a presentation of Committee work plans. Maybe after 

this session with Handling, I think maybe we, we all need to stand up for a moment, but 

do not leave the room. Stretch your legs and then we will go to, then we will start with 

the work plans. Just a moment or two.

[BREAK]

Barry Flamm: What do I do? [Inaudible] The Board meeting is back in session. Please come to 

order. We are going to present the work plans, the Subcommittee work plans in the order 

of the way they, the Committees were listed in the beginning of the agenda. And that is 

the CACC will begin, followed by GMO ad hoc Committee. 

Joe Dickson: Thank you, Mr. Chair. Michelle, do you have the work plan that was presented you 

know?

Michelle Arsenault: [Inaudible].

Joe Dickson: Well, I will just use my words. [Laugh].

Michelle Arsenault: Okay. 

Comment [JMS16]: 03:45:00

Comment [JMS17]: 03:46:50

Comment [JMS18]: 03:53:40
Meeting Of The National Organic Standards Board

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46

Joe Dickson: Thank you. The Compliance, Accreditation, and Certification Subcommittee’s 

work plan for the fall of 2012. The first item is the discussion document on sanitizers and 

100% organic products will most likely be turned into a recommendation, based on the 

feedback we received through public comment at this meeting. The Material Review 

Organization recommendation I believe is officially complete and off of our work plan. 

Also, for fall 2012, we will be covering monitoring practices and procedures for organic 

system plans, as described in 205.201(a). That is a discussion document for the fall that 

will be worked on by Mac and Barry. We also have on our work plan a recommendation 

or, or other communication related to calculating the percentage of organic ingredients 

and some of the issues surrounding the 95% organic category, and how those, those

ingredients factor into the cert-, certified multi-ingredient products. Barry will be leading 

us through some reconsideration of the earlier 2009 joint Crops and CACC biodiversity 

recommendation and a few loose, loose ends that are trailing from that recommendation 

and may necessitate further work or consideration. That is the extent of our, our fall work 

plan, as it currently sits on our agenda. Thank you, Barry. 

Barry Flamm: Thank you, Joe. Next up is Zea, present the...

Miles McEvoy: Barry, could, could the Program make some comments on this? 

Barry Flamm: Yes, certainly.

Miles McEvoy: We had a few questions on a couple of these items. On the sanitizers and 100% 

organic products, we are going to, as agreed upon, we are going to provide an overview 

to the CACS of food contact substances, processing aids, et cetera. And, I think there 

needs to be a lot more work done in this area, and not sure if it is going to be ready for a 

proposal by the fall, so, but, certainly willing to work with the, with the CACSC on that. 

Okay. Review criteria, that is done. Let us see, monitoring practices. We just wanted to 

get a little more clarification on what that particular item is, monitoring practices and 

procedures for organic system plans, so that we can continue to work with the 

Subcommittee on clarifying that. Calculation of percentage of organic, we are, that is 

very exciting that you are going to work on that. That is a very important item. And 

biodiversity, we already have the 2009 joint Crops and CACC recommendation that we 

are working on implementation. So, look forward, I guess, to more information on that as 

we work towards implementation of that biodiversity recommendation. 

Joe Dickson: Great. On the sanitizers and 100% organic products, yeah, depending on the timing 

of more clear information from the Program, we look forward to working with you guys

over the summer and, you know, if it is right for something in the fall, it is. If not, it will 

stay on our work plan until such a time that it is appropriate. I am going to ask John to 

chime in a little on the 205.201(a) recommendation or issue rather. 

John Foster: Yeah, 205.201(a)(3). 

Joe Dickson: Yes. Sorry.
Meeting Of The National Organic Standards Board

May 25, 2012

47

John Foster: So, the idea there, this has, this has been kind of something of a undiscovered 

country of the organic system plan for a while. It has, it has been the least, I do not want 

to say least monitored, but it is certainly the least articulated part of the organic system 

plan. There is a fair amount of cloudiness about what it means and how it should apply. 

This is coming from some certifiers from many inspectors having trouble with the, what 

that means. And so, there was some public comment, I believe, at the last, I cannot 

remember if it was the meeting or the meeting before now, but for clarification on this

and suggested some pathways to, to help, well, suggested an interpretation, actually, of, 

of what that meant. Meaning, how are operators monitoring their own systems, such that 

they can ensure compliance with the Act, compli-, or consistency with their own OSPs

over time, since the inspector is not there every day. It was, that was, that is my 

recollection of the gist of the need or the, or the ask. And so, this, this work plan item is 

designed to flesh that out, gather more information from those constituencies. And, and if 

there is a need for, for clarity that we can get, that would be helpful, then that is what we 

would work toward. 

Barry Flamm: Thank you, John. We will, we will have to move on. We do have to close this 

meeting on time at 12 o’clock so there is limited time for each of the Committee’s 

presentation and we have allocated three minutes per Committee to present the work 

plan.

John Foster: Just I wonder if the Program wanted to respond to that. 

Miles McEvoy: Yeah, that was some helpful clarification. We just have two quick things that we 

are going to ask for clar-, some help with. The residue testing response to the IOG audit, 

we will put that in writing to the Board and the CACS in particular. And also sanitizers 

and milk trucks: we are looking for the Board to help us and collaborate on those two 

projects as well. 

Barry Flamm: Thank you. Zea, would you present the [inaudible] [GMO ad hoc Committee work 

plan]?

Zea Sonnabend: Okay. We have three particular things for our fall work plan. We are going to 

put forward I hope a seed purity discussion paper. This, you know it all starts with the

seed and keeping things free of GMOs, and this may not advance further to a 

recommendation but it will be a call to the community to ask for input on this very 

important topic. We also will help give feedback to the NOP and their response to the 

IOG audit about testing feed products. And we will be discussing plant breeding issues 

such as cell fusion and mutagenesis. And there are some other plant breeding issues, and 

I am not sure, we will be doing this in conjunction with the Crops Committee. I am not 

sure if it will result in a discussion paper or a recommendation, but, we will see. 

Barry Flamm: Okay.

Miles McEvoy: That sounds great. 

Comment [JMS19]: 04:00:00
Meeting Of The National Organic Standards Board

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48

Barry Flamm: Okay, we will move on to the Materials Committee. 

Jennifer Taylor: Thank you, Barry. The Materials Committee draft work plan will include:

To develop and implement the framework for the NOSB research priorities that have 

come out of the implementation of the research priorities frame, framework 

recommendation. 

To examine issues focusing on genetically modified organisms. 

To examine and update petitions and technical review process jointly with the Policy 

Development Committee.

To examine confidential business information transparency, again, also jointly with the 

Policy Development Committee. 

To examine ion exchange chromatography and impact. 

Thank you. 

Barry Flamm: Questions, comments, Program? 

Miles McEvoy: So, from the Executive Committee, we have the ion exchange chromatography 

that, that is, that sounds great. And then we have the examine CBI and petitions, right?

That was the second one? 

Jennifer Taylor: Yes.

Miles McEvoy: That is great. And then, the, there was a third one on identifying substances 

made with GE materials. Was that the one? 

Jennifer Taylor: Right, to examine issues focusing on that. Another one was to examine and 

update the petitions technical review process. 

Miles McEvoy: What was the fourth one?

Barry Flamm: Jennifer, would you speak up? I cannot hear you. 

Jennifer Taylor: [Inaudible] Oh, okay, I am sorry. Examine the, and update petitions, the 

technical review process. 

Zea Sonnabend: Also, they are collecting the research priorities was the first thing she said, 

which is as per the recommendation that was passed this meeting. 

Jennifer Taylor: Right. And then...
Meeting Of The National Organic Standards Board

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49

Miles McEvoy: Okay, thank you for the clarification. 

Jennifer Taylor: Alright, okay.

Barry Flamm: Okay. Miles? You okay? Next is Crops. Jay, please.

Jay Feldman: Okay, we have a number of petition substances on the Crops Committee that we 

are dealing with, ferric phosphate, snail bate, PGML, oxidized lignite, biodegradable 

plastic mulch, polyoxin D zinc salt, vinasse, sulfuric acid, aquaculture materials for 

plants, CO2, is one I guess, micronutrients, perhaps. I am not sure. Some housekeeping on 

Rotenone. 

And then we are not sure where things are at with streptomycin and tetracycline. But, 

those will have to be petitioned to the Board if there is a, a desire to maintain their uses. 

In the inerts ingredients category, as you know, we have the List 4 inerts, or, or the sort of 

overall inerts policy, now. And then we have, as I have mentioned throughout this 

meeting, we have another individ-, a number of petitions for individual inert ingredients:

Polyglyceryl Phthalate Ester Coconut Oil Fatty Acid, 1,1-Difluoroethane, Magnesium 

Sulfate, Monphydrate, Ethylene DDSA or EDDS, as it is known, Turpenes. So those are 

the inert issues that we have got before either pending or sort of on the plate, as it were. 

And then, other issues that have come up that have been on the work plan, so I guess we 

have to really decide whether we are going to do something with these things: Seed 

Purity, Plant Breeding, review public comments on GMO issues, Mushroom standards, 

food safety, Fire Blight, which obviously is under streptomycin and tetracycline, and 

Organic Seeds, so I guess that is part of seed purity, but one was GMO and the other was 

more general. Thank you. 

Barry Flamm: Questions from the, from the Program?

Miles McEvoy: That is a long list, but it looks great. [Laugh].

Barry Flamm: Okay, thank you, Jay. Next is Livestock Committee. 

Wendy Fulwider: Thank you, Barry. Michelle, you have our list?

Michelle Arsenault: [Inaudible].

Wendy Fulwider: Okay, I had sent a revised one, but that is fine. It is close. We will begin our 

work on petitions for Nonanoic Acid and Pet Food Amino Acids. And then we will be 

working on aquaculture. We will be working on Carbon Dioxide, Chlorine, 

Micronutrients, Vaccines and Biologics. We will have a GMO vaccines update. We will 

try to complete the rest of this list as it is rather lengthy. There is a Parasiticides for Fiber 

Bearing Animals discussion document, a Poultry-Omnivore Diets discussion document, 

and then, of course, the Beef Guidance, Dairy Guidance, and Swine Guidance. 
Meeting Of The National Organic Standards Board

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50

Barry Flamm: Thank you, Wendy. Comments from the Program? 

Melissa Bailey: Thank you, Wendy. In terms of the work plan for additional species-specific 

guidance, or I think you might have had up there a mention of the stocking density for 

other species that were not covered in the previous recommendation. The Program at this 

time would appreciate us taking the time to focus on looking at the Animal Welfare 

Recommendation that the Committee already passed. And, sort of allow us to figure out 

what we are going to do with that recommendation before we start getting more and more 

additional information and proposals from or recommendations from the Board on 

species-specific guidance and the stocking densities. You guys did a lot of great work 

before. We have not fully digested all of that work, yet. And so, we would like an 

opportunity to do that before having the Committee spend a lot of time on these 

additional items. So.

Barry Flamm: Wendy? 

Wendy Fulwider: We were just considering working on refinements to the pieces that we have, if 

we have the time.

Barry Flamm: Any other comments? Okay, Colehour, Policy. 

Colehour Bondera: Michelle, can you...? 

Michelle Arsenault: [Inaudible].

Colehour Bondera: Yeah. Thank you. Yes, so, for the work plan of the Policy Development 

Committee – go to the next one, Michelle, please – for October 2012 and beyond. We 

may or may not be able to read it, sorry about the font size issue. I started adding too 

many things and frankly when I added back the Public Comment Policy, the Public 

Communications Policy, and the Conflict of Interest Policy back to this that were not on 

it up until this point in time, it did confuse it a little bit. But, those three items are 

appearing at the top of the list along with Policy Procedure Manual Updates, which does 

include, it was already on there before, the review of the Ethics Rules, our you know 

existing and updated components of that PPM. 

We also need the New Member Guide Update to be, to be dealt with, and we are hoping 

from a time, time frame perspective all of those things will be dealt with in October 2012. 

But we will see. We have on there, and we will get the NOP’s response, but, the Material 

Initiation Policy, and if necessary, Jay can speak further to that one. But, that is where, 

because we have with the NOP discussed this to some degree, in terms of where mate-, 

where the initiation comes from, in terms of having it in policy, if, if it is coming from 

the public, if it is coming from the NOP, or if it is coming from NOSB, and what the 

processes are for that. 
Meeting Of The National Organic Standards Board

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51

The Confidential Business Information joint with the Materials Committee was 

mentioned by the Materials Committee, and that is on there as well. I think that the next 

one overlaps with that presentation, too, from Materials, which is technical review, policy 

review and, which includes a proposed threshold to stage technical review. The 

decisive/indecisive determination on the NOSB votes is on there. And, and I am not sure 

in what form that will take. But, I wanted to leave it on there, because we are working 

with the NOP on that issue, but just so that if we need to put it forth in its own way at one 

of these meetings, that we are avail-, able to do that. 

And then I have added on there “Convening of Technical Advisory Boards and Working 

Groups Policy” so that that is clear within the Policy Procedures Manual, how we are 

dealing with that process of those things. So, we are all on the same page with that. And 

so, I, I welcome any comments. Thank you. 

Barry Flamm: Comment from the Program?

Miles McEvoy: Yeah. I, I think we covered most of these things at the last Executive call. If you 

could put that back up there so that I could respond to it, that would be great. Thank you. 

The Policy Procedure Manual updates, we are certainly going to work very closely with 

the PDSC on that, including the Conflict of Interest, Public Comment Policy, Public

Communication, New Member Guide, all very committed to, to working with the 

Subcommittee on that. Material Initiation Policy, we are, I, I think this is related to, Jay, 

what we talked about a few weeks ago, on how, clarifying the process for how substances 

are brought to the Board and, but we still need a little more clarification on, on what that 

is. And I guess we can work that out as we move, move down the road on that. But, we 

are, I am still not real clear on exactly what the parameters are, and. and further 

conversation I think will help to clarify that. So, I do not know if you want to add 

anything to try to help clarify that. 

Jay Feldman: Yeah, I mean... Yes, thank you. Yeah, the, it is pretty clear what the, what the 

public needs to do to get a material before the Board, and that has been laid out for many 

years in the Policy Procedures Manual. It is not clear what the process should be for the 

Board. If the NOSB was to revisit in, a material prior to Sunset or in the absence of a 

petition, how that would happen and the hurdles that we would need to go through are not 

clear. So, that was just, maybe it just requires clarification. 

Miles McEvoy: Okay.

Nick Maravell: Jay, would that include, I am, I am not sure, quite sure that I am following it

completely. But, suppose we get some form of a, of a policy recommendation or 

clarification from the Program, requesting us to add something to the National List. 

Would that be part of that? 

Jay Feldman: Right, yes. Yes, exactly. 

Nick Maravell: Okay. Thank you. 
Meeting Of The National Organic Standards Board

May 25, 2012

52

Barry Flamm: Okay, Thank you for the comments. Miles, did you have anything?

Miles McEvoy: Yeah. The, the other part on the decisive/indecisive vote, that we are providing 

specific information to the Policy Development Committee, Subcommittee on that, and 

what will become of that, whether there will be something in the fall to, to either present 

or discuss, I guess we will, we will see how that process unfolds. 

Barry Flamm: Okay, thank you. 

Melissa Bailey: Barry, could I just add one thing? Could you put that up? Sorry. On the CBI 

information petitions and the technical reviews, including this two-stage concept that was 

presented: If the Committee could, I, I understand you will be working with Materials, 

but if you could make sure to keep Lisa Brines in the loop, because she does work quite a 

bit with those contracts for the TRs, and that will impact our process at the Program. So I 

would appreciate her being part of that. 

Colehour Bondera: Yes, thank you. And thank you NOP for your input, and we will work with 

you and I will make sure I am cc-ing every member and inclu-, make sure Lisa is 

included. Thank you.

Barry Flamm: Colehour, does that conclude your presentation? 

Colehour Bondera: Yes. Thank you, Mr. Chair.

Barry Flamm: Thank you. John, Handling, will you present your work plan, please?

John Foster: Sure. Michelle, could you put that up, please? The, yeah, from the Excel sheet. If 

we cannot see it, does that mean that we do not have to do it? 

Unknown Female: [Sigh]

John Foster: That was an old joke. Little joke. 

Michelle Arsenault: We are just trying to get it big enough so people can see it.

John Foster: Thank you, including me. 

Michelle Arsenault: That look okay?

John Foster: Thank you. Handling Committee has a, a fairly long list of petitioned materials. 

And, and I have already spoken with Melissa a little bit on, on knowing that we need to 

strategize a little bit to make sure that we are, we are going to get through all of these. 

They are, are all petitions. There is no Sunset items. The only exception is a, hopefully a

proposal on, if not a discussion document on, other or ancillary ingredients. But, the 

remaining work plan items are all petitions. They are for L-carnitine, L-methionine, BetaComment [JMS20]: 04:15:00
Meeting Of The National Organic Standards Board

May 25, 2012

53

carotene, Taurine, Nucleotides, Ascorbyl palmitate, Lutein, Lycopene, Barley Betafiber,

Sugar beet fiber, Bergamot bitter orange powder, Sulfuric acid, and if we can get the TR 

for DBDMH prior to about August 20th, I am sorry about August 10th, we can probably 

get, fit that in, also. That is the work plan. 

Miles McEvoy: Sounds great. 

Barry Flamm: Thank you, everyone. Well we are coming down to the end right now. And, I want 

to thank all of you diehard participants that are still here, and for the record, all the people 

who presented comments during the week. I think we had a, had a extremely interesting 

and valuable interactions and participation and tremendous comments. And, I, I would 

like to thank the, the Board members for the, their great cooperation in, in dealing with a 

new format. And, I appreciate all what you have done, and thank, thanks to the NOP for 

their, for their partici-, participation and help and the advice that they have given. So, 

with that, I adjourn this meeting of the Board. 

Nick Maravell: Mr. Chairman? Mr. Chair, could I introduce another item for the Board to engage 

in? 

Barry Flamm: You want to introduce a ...

Nick Maravell: Basically, a discussion to ask. We have changed our formats a little bit here. 

And, we have got some new policies and procedures we are following. And, I am just 

sort of wondering. We want, we might want to go around and just sort of ask a minute or 

less what worked and what did not work about this meeting, and to include the NOP staff 

in that discussion. So, I, I, that, that is my suggestion.

Barry Flamm: We will definitely have a thorough discussion and evaluation and dialogue on 

considering talking about what worked and what did not work under the new format. 

And, that will be done subsequently. I have no, no objection with the time left, if you, if 

members want to just off the cuff, but I think we need some of this to soak in and think 

about and talk about later. But, I, I have no objection if, and since, Nick, you, this is not a 

motion or anything, but it, since you introduced it, do, would you like to make a few 

comments and keep them brief? We have, according to my, I do not know if my, my

clock, how much time does other people have? We have got to be done.

Nick Maravell: You have got to watch me carefully. 

Barry Flamm: I have two different clocks here, and they give me different times, so.

Miles McEvoy: You have got about 15 minutes. 

Barry Flamm: Okay, we have, we have time. Go ahead, Nick. 

Nick Maravell: I think the new public comment arrangement whereby we try to group comments 

of similar impact or, or topic is very good. I think we stumbled in how we arrange and get 
Meeting Of The National Organic Standards Board

May 25, 2012

54

the general comments and how we have enough time to get the full view of information 

from people in the field, and particularly national organizations that are commenting on 

multiple items. So, I think that that might be something we would want to work on, in 

terms of increasing the public comment. And I will st-, I will also comment that I think it 

has, it has taken a lo-, I am not sure I have gotten used to the rhythm of how the 

Committee decisions are made during the meeting, as opposed to how they were at 

previous meetings, when we seemed to have more time to readjust. So, I will just, those 

are my comments. 

Barry Flamm: Anybody else want, would like to make a comment at this point in time? Mac, go 

ahead, please. 

Mac Stone: I, I too like the format of grouping by Committee conversation. It does seem 

awkward of wordsmithing, sort of on the fly. So, how we can structure that, maybe 

around breaks or whatever. But, I like the clustering, but just not the wordsmithing onthe-fly.

Barry Flamm: Anybody else? Zea.

Zea Sonnabend: This is more of a question. But, how much longer today do we have to turn in 

our final forms for our motions that we made with the final votes, which I might have 

gotten all down right, and might not have. 

Barry Flamm: As soon...

Zea Sonnabend: Because I, that seems to me to be a problem, because we are in the thick of the 

discussion and so now I have to fill out this form. And so I have to wait until we are 

done. So how much longer? 

Barry Flamm: That is, I am going to be here until 2 o’clock. I thought that would allow 

everybody time .... 

Zea Sonnabend: [Laugh] Is not it how long Miles is going to be here though or...? 

Barry Flamm: I do not know. I have not ...

Zea Sonnabend: Do we turn them in to ...? We turn them in to you, Barry.

Barry Flamm: Yeah, you turn them into me. And are you going to be doing it electronically or 

hard copy?

Zea Sonnabend: Electronically, I do not have a printer. 

Barry Flamm: Okay. Well, just copy me and copy Michelle, that is all. 

Zea Sonnabend: Okay, and if the vote is wrong, you will double check it?
Meeting Of The National Organic Standards Board

May 25, 2012

55

Barry Flamm: I will.

Zea Sonnabend: Okay, thank you. [Laugh].

Barry Flamm: Soon as I can open my computer. 

Zea Sonnabend: I, because I just see that a flaw, like having to do this final thing right now and 

so maybe that could be thought about for the future. 

Barry Flamm: Yes, I know, handling this is a particular problem. I think everybody else has, has

got theirs done. John, John, please.

John Foster: I was just going to say that I, I as chair need to send that, I need to send that to 

Barry.

Zea Sonnabend: [Inaudible].

John Foster: I will be here as, as long as I need to be here. So, but, but, procedurally, it needs to 

go through the chairs, to Barry. And then ... 

Barry Flamm: Yeah, right. Thanks, John.

John Foster: Okay. And then, my, I really enjoy, I really appreciated the, even though it took me 

a while to get into the groove of it, I really appreciated the introduction of each material. 

That was really helpful. And it, it got, once, once I got used to the idea, I think it really 

helped to set a good cadence. And, I, I think that has, that is only positive, so. That was 

my big, I liked that part of it. 

Barry Flamm: Any other comments? Does the Program want to make a comment? Oh, oh, 

Jennifer.

Jennifer Taylor: Well, I, I actually did not have a comment myself. I was trying to get the 

attention of Calvin, because Calvin had been talking to many of us. And also I believe 

that he talked with you, Miles, about the introduction of a new kind of concept and a way 

to hear from the public. And then, think about it in a while. And then address some of the 

issues. Calvin? Can you talk about it? 

Calvin Walker: I have closed that part of my brain. 

Jennifer Taylor: Oh, okay.

Calvin Walker: I, I believe that was on Tuesday, mentioned sometime we are making quick 

decision, maybe the format that we have may need to be tweaked to allow more time to 

digest recommendations. Because, the Supreme Court, city councils, sometime do not 

decide things on the fly, on a short time, on a short time on it. So, maybe as we look at 
Meeting Of The National Organic Standards Board

May 25, 2012

56

this arrangement, as far as voting, discussing, particular issue, we may have to look at a 

different arrangement. That was the essence of it. Maybe some of these things could be 

brought back and voted on at another time at the next meeting, something of that nature. 

Not everything.

Barry Flamm: John, please? 

John Foster: To, to add the, to what Calvin was saying, he and I spoke about it a little bit, and it 

seemed to us that if we, that part of the problem in trying to implement something like 

this in the past has been that in, at least since I have been on the Board, we have been in 

high season for Sunset, and we really did not have the, the time to get out ahead of things. 

And right now, we are in a bit of a low season of Sunset items. So if, if we are going to 

look into this, now is exactly the right time to do it, so that we can incorporate Sunset 

review in addition to petitions in that kind of more proactive way. So, so there is a little 

time-of-the-essence feature here. But I think it is a good opportunity and we should give 

it, give it some good thought. I, I thought it was a great idea. 

Jennifer Taylor: Yeah.

Barry Flamm: Thank you. 

Jennifer Taylor: Thank you.

Barry Flamm: Any other Board, Board members [inaudible]? 

Unknown Male: Just the Program.

Barry Flamm: Any other Board member? Miles, would you like to make a [inaudible] comment? 

Miles McEvoy: Yeah, I would just, just like to thank the Board for your public service, all the 

hard work that you did. You had a lot of really difficult discussions and, and fruitful 

discussions. Lot of really good work that was done. Really loved the process. We will 

continue to work together and provide the support we can. But I would like to give a 

round of applause to the Board members and their service. 

Crowd: [Clapping] 

Barry Flamm: Thank you, and I do not want to be too abrupt, but if there is no other new 

business, I adjourn this meeting, and thank you all. 

Crowd: [Clapping] 

Mac Stone: [Inaudible].

Barry Flamm: Huh? Oh, Mac says I got to hit it one more time. 

[Event concluded] (End)