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UNITED STATES DEPARTMENT OF AGRICULTURE

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NATIONAL ORGANIC STANDARDS BOARD

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PUBLIC COMMENT WEBINAR

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TUESDAY

APRIL 19, 2016

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The meeting was conducted by webinar at 1:00 

p.m., Tracy Favre, Chair, presiding.

NOSB Members:

TRACY FAVRE, Chair

HAROLD AUSTIN

CARMELA BECK

HARRIET BEHAR

JESSE BUIE

TOM CHAPMAN, Vice Chair

LISA DE LIMA, Secretary

EMILY OAKLEY

SCOTT RICE

JEAN RICHARDSON

A-DAE ROMERO-BRIONES

DAN SEITZ

ZEA SONNABEND

ASHLEY SWAFFER
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USDA STAFF:

MICHELLE ARSENAULT, Advisory Committee

Specialist

LISA BRINES, National List Manager

PAUL LEWIS, Standards Division Director

MILES McEVOY, Deputy Administrator

DEVON PATTILLO, Materials Specialist

BETSY RAKOLA, USDA Organic Policy Advisor

EMILY BROWN ROSEN, Agricultural Marketing

Specialist

JENNY TUCKER, Associate Deputy Administrator

JESSICA WALDEN, Materials Specialist

SONYA WILSON, Communications Specialist

WEBINAR ATTENDEES:

FARLEY BARICUATRO, Seaweed sourcing manager

COLEHOUR BONDERA, Citizen

MARIE BURCHAM, The Cornucopia Institute

ROGER CLEMENS, USC

DEBRA CLEMENT, Citizen

KELLY DAMEWOOD, California Certified Organic

Farmers (CCOF)

PAUL DeGRANDPRE, Organic Handler

NICOLE DEHNE, Vermont Organic Farmers (ACA)

PATRICIA Di GASBARRO, Manufacturer

KATHERINE DiMATTEO, Wolf, DiMatteo + Associates

STEVE ETKA, National Organic Coalition

BARRY FLAMM, The Cornucopia Institute

GRACE GERSHUNY, GAIA Services

ERIK GUNDERSEN, MOSA

ZEN HONEYCUTT, Moms Across America 

RYAN HOWARD, Chicago Vegan Foods 

AMBER KING, Citizen

ESTEBAN MACIAS, Organic growing technical

advisor

WILLIAM MATAKAS JR., FMC Health and Nutrition

Asia Pacific

WEST MATHISON, Grower 

MADISON MONTY, Northeast Organic Farming 

Association of Vermont (NOFA-VT)

MEGAN PARKER, Citizen
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PETER PITTS, Center for Medicine in the Public

Interest

AMBER POOL, California Certified Organic Farmers

(CCOF)

SHAKEEL REHMAN, Fairlife LLC

CHRISTINE RICH, Citizen

MARGARET SCOLES, International Organic 

Inspectors Association 

TYLER SMITH, Consumer Reports Food Safety and

Sustainability Center 

KELLY TAVERAS, OTA

JOANNE TOBACMAN, Department of Medicine,

University of Illinois at Chicago 

KRISTEN WALKER, Citizen

ANGELA WARTES-KAHL, Citizen

MYRA WEINER, TOXpertise LLC
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1 P-R-O-C-E-E-D-I-N-G-S

2 1:04 a.m.

3 MR. LEWIS: Good afternoon and welcome 

4 NOSB members and the public. We appreciate NOSB 

5 members participating in this call and for all your 

6 efforts serving on the Board. We are particularly 

7 excited about the opportunity for the Board to 

8 conduct this meeting via teleconference, providing 

9 the opportunity to greater public access to NOSB 

10 meetings. This meeting, like other meetings of 

11 the NOSB, operate under the auspices of the Federal 

12 Advisory Committee Act. We are looking forward to 

13 getting comments from the public to assist the 

14 Board in preparing their recommendations to the 

15 USDA.

16 I want to thank especially my National 

17 Organic Program colleagues for their help behind 

18 the scenes to bring us this teleconference today. 

19 Also to thank our Chair, Tracy Favre, for all her 

20 efforts providing leadership and guidance for the 

21 Board. Thank you and looking forward to a good 

22 meeting. I'd like to now invite our Chair, Tracy 
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1 Favre, to make some remarks and to lead us today.

2 CHAIR FAVRE: Hi. Good afternoon 

3 everybody. Can everybody hear me okay? Board 

4 members, I know you can respond, everybody else is 

5 muted.

6 MS. TUCKER: Yes, we can hear you.

7 CHAIR FAVRE: Great, thanks. Really 

8 appreciate everybody coming today to participate 

9 in this webinar. I feel very, very strongly that 

10 using technology to expand our opportunity for 

11 comment from the public is a wave of the future and 

12 I'm delighted to see that we have a very active 

13 sign-up list for commenters today. In fact, I will 

14 just note that we have a very packed agenda today, 

15 so I'm going to be very strict on the time limits 

16 so that everybody gets a chance to have their 

17 comments in the time period that we have allowed.

18 So, just everybody be aware of that, 

19 when you hear the timer, you're not going to get 

20 much latitude. I appreciate your cooperation with 

21 that. And in the interest of getting back on 

22 schedule time wise, I'd like to go ahead and turn 
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1 this over to the conference organizers to do a full 

2 list of the Board members present and then we'll 

3 get started with the public comments after that. 

4 Thank you very much.

5 MS. TUCKER: Great. Thank you so much, 

6 Tracy. We're going to take care of a couple of 

7 housekeeping items here. First, we're going to 

8 read the names of Board members present into the 

9 record. This conference call is being 

10 transcribed, so the names of participating Board 

11 members will be captured in the transcript. 

12 Michelle Arsenault is going to do that. And then 

13 also, Michelle is going to demonstrate what the end 

14 of public comment warning sounds like so if you're 

15 giving public comment, you're going to know what 

16 the signal is that marks your being done. So, 

17 Michelle, please go ahead and read in Board members 

18 for the record.

19 MMA: Sure. Thank you, Jenny. Harold 

20 Austin, Carmela Beck, Harriet Behar, Jesse Buie, 

21 Tom Chapman, Lisa de Lima, Tracy Favre, Emily 

22 Oakley, Scott Rice, Jean Richardson, A-dae 
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1 Romero-Briones, Zea Sonnabend, Dan Seitz, and 

2 Ashley Swaffer. All right. And here is what, 

3 when your three minutes is up, we're going to sound 

4 the timer here and I'm going to set it off so you 

5 guys can hear what it sounds like in just a second. 

6 And so, we appreciate whether you're mid-sentence, 

7 maybe you can finish your sentence, but we'd 

8 appreciate it if you can -- I can't do seconds here.

9 I'm going to start the timer here. 

10 We'd appreciate it if you would end the sentence 

11 you're speaking about and end at that point your 

12 public comment. And then Tracy will see if the 

13 Board members have any questions for you. We do 

14 have a completely full agenda and I think we're 

15 going to run a little late, only because we're 

16 starting a little late. So, hopefully everyone 

17 can stay with us through the whole thing.

18 MS. TUCKER: Okay. Well, while we're 

19 waiting for the timer to ring, we've got about 25 

20 seconds, as a reminder, if you run into technical 

21 problems during the presentation, you can go to 

22 Readytalk.com and they can help you with technical 
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1 troubleshooting. If you activate the chat button 

2 on the side of your screen, you will chat, all the 

3 presenters will see you, please don't use that 

4 function unless we're either trying to get a hold 

5 of you, because you're coming up -- there we go, 

6 so that sounded like a doorbell. Can everyone hear 

7 that?

8 CHAIR FAVRE: Yes, we can hear it.

9 MS. TUCKER: Once you give your public 

10 comment, that's what you'll hear to tell you to 

11 stop. Again, in the meantime, if you need to send 

12 us a message, you can use the chat button on the 

13 left of your screen. If you're having technical 

14 difficulty, please go to Readytalk.com. So, I 

15 think we are ready to get started.

16 CHAIR FAVRE: Okay. Thanks, Jenny. 

17 Thanks, Michelle. I appreciate all your hard work 

18 on this. Just as a reminder, the comment period 

19 is restricted to three minutes. We have allocated 

20 about two minutes for questions and answers for the 

21 Board. And we need to try to stay close to that 

22 with whatever flexibility we can. And as a 
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1 reminder to Board members, the way that you request 

2 a chance to ask a question is in the chat box to, 

3 not raise your hand, to include a question mark that 

4 I will see and then direct you to proceed with your 

5 question. So, our first commenter up is going to 

6 be Nicole Dehne and we're going to have Roger 

7 Clemens on deck after that. So, take it away, 

8 Nicole.

9 MS. DEHNE: Okay. Can you hear me?

10 CHAIR FAVRE: Yes, we can.

11 MS. DEHNE: Oh, excellent. Okay. So, 

12 my name is Nicole Dehne. I am the Certification 

13 Director for NOFA Vermont's Certification Program, 

14 Vermont Organic Farmers. We currently certify 

15 over 600 farmers and processors. And I want to 

16 thank the Board for the opportunity to speak today 

17 and I also wanted to acknowledge how much I 

18 appreciate being able to address the Board without 

19 having to travel to D.C. this time, so thanks very 

20 much.

21 I'm going to comment on four items, 

22 hydroponics, biodegradable bio-based mulch, 
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1 lidocaine and procaine, and parasiticides. For 

2 hydroponics, certification of hydroponic systems 

3 we feel fail to recognize the essential functions 

4 of complex soil ecosystems and the role that 

5 organic farmers play as stewards of soil ecology. 

6 So, hydroponic systems reduce crop production to 

7 basically a feeding system of a nutrient solution 

8 and an inert growing medium. And furthermore, 

9 there's lots of inconsistencies among certifiers 

10 in regards to how they certify hydroponic systems 

11 and this diminishes the value of the organic label. 

12 In February this year, Senator Leahy issued a 

13 letter to Secretary Tom Vilsack strongly advising 

14 the NOP to issue a moratorium on the certification 

15 of new hydroponic operations and we strongly 

16 support the Senator's request and we urge the NOSB 

17 to reconfirm the Board's commitment to soil-based 

18 production.

19 So, under biodegradable bio-based 

20 mulch, we often hear from organic growers about 

21 their desire to use this mulch. We even hear from 

22 some growers that say that the reason they haven't 
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1 decided to certify is because they are not allowed 

2 to use this material. The current NOP Policy Memo 

3 15-1 currently requires that biodegradable mulches 

4 be 100 percent bio-based, despite the fact that the 

5 NOP Rule doesn't require that specifically. The 

6 problem with this interpretation is that there are 

7 no mulches available at this time that meet that 

8 100 percent bio-based requirement. So we 

9 encourage the Crops Subcommittee to review the 

10 policy as requested by the NOP and find a reasonable 

11 solution to this issue that encourages production 

12 of biodegradable mulch that has a lot of bio-based 

13 content, while taking into consideration what is 

14 feasible and available in the marketplace.

15 For lidocaine and procaine, we strongly 

16 believe that the NOSB's proposal to reduce the 

17 withholding time for these anesthetics will 

18 greatly improve animal care on organic farms. The 

19 current withholding period discourages the use of 

20 these important tools. The NOSB recommendation to 

21 change the required withholding times to double the 

22 current recommendations is reasonable, consistent 
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1 with withholding recommendations for other 

2 livestock materials, and we believe it will improve 

3 animal welfare on organic farms.

4 And then as far as the NOSB proposal for 

5 parasiticides, on dairy farms in Vermont, 

6 parasiticides are rarely, if ever, used on 

7 lactating animals because generally these adult 

8 animals can tolerate parasites better than young 

9 stock. There are instances, however, like for one 

10 example, when a herd might have lungworm, where 

11 emergency treatment of lactating animals is 

12 needed. In situations like these, it's extremely 

13 important that producers are not unduly burdened 

14 with long milk withholding, which could be 

15 expensive and unnecessary, and most importantly, 

16 could discourage the needed use of these materials. 

17 Because of this, we support the NOSB recommendation 

18 that includes lessening the withholding times for 

19 fenbendazole and moxidectin and creates an 

20 allowance for the use of parasiticides on fiber 

21 bearing animals. And that's it.

22 CHAIR FAVRE: Thank you very much. Does 
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1 anybody have any questions for Nicole? Okay. 

2 Thank you very much, Nicole.

3 MS. DEHNE: Okay. Thank you so much.

4 CHAIR FAVRE: Next up is Roger Clemens. 

5 And just one correction, I did misspeak, it is four 

6 minutes for the webinar, sorry, it's three minutes 

7 for public comment in person. So you get a little 

8 bit of bonus for putting up with the hassle of the 

9 technology. And, Mr. Clemens, just to bring your 

10 attention to it, does have a presentation that 

11 he'll be sharing with us via the webinar if you are 

12 on the computer. And next up after Roger on deck 

13 is Grace Gershuny. Mr. Clemens, please proceed.

14 MS. TUCKER: Yes, hold on. I need to 

15 unmute. I need to find him so I can unmute him.

16 CHAIR FAVRE: Okay. If you're 

17 speaking, Mr. Clemens, we can't hear you yet, but 

18 we will soon.

19 MS. TUCKER: Yes, Roger, we'll tell you 

20 when you can go.

21 CHAIR FAVRE: And we appreciate 

22 everybody's patience on this. I have a picture in 
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1 my mind of the NOP staff manning this, running 

2 around like crazy people unmuting and muting, so 

3 just have some patience with everybody. Just like 

4 an in-person meeting, we can't always expect things 

5 to go off without a hitch, but we appreciate your 

6 patience and your humor as we work through it.

7 DR. CLEMENS: Are we connected?

8 CHAIR FAVRE: Super.

9 DR. CLEMENS: We are?

10 CHAIR FAVRE: Please proceed. Yes, we 

11 are.

12 DR. CLEMENS: Thank you very much. 

13 Hello and good afternoon. This is Roger Clemens. 

14 I'm a professor at the USC School of Pharmacy and 

15 the International Center for Regulatory Science. 

16 I bring to the school 40 years of experience in the 

17 global nutrition, food safety, toxicology, and 

18 food regulation environment. Thank you for this 

19 great opportunity to present these comments in 

20 support of carrageenan remaining on the national 

21 list. Next slide please. There are two critical 

22 factors to consider when assessing the safety of 
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1 a food additive.

2 The first is its history of exposure or 

3 history of use. The second is an understanding of 

4 animal toxicology, metabolic fate, and human 

5 studies. These are imbedded in the statutes of the 

6 United States in the Code of Federal Regulations. 

7 Such assessments allow us to determine acceptable 

8 daily intake. Without these kinds of data, we 

9 cannot determine the safe use of any food 

10 ingredient, including carrageenan. Next slide 

11 please.

12 In assessing the safety of carrageenan 

13 in human food, there are two key publications that 

14 validate its safe use. They are listed on this 

15 slide, indicated by 1 and 2. These publications 

16 noted that food grade carrageenan is utilized as 

17 a food additive and ingested by humans engaged in 

18 normal dietary patterns. There is no demonstrable 

19 evidence that this class of component pose any 

20 health risk ingested as a food additive. The JECFA 

21 on food additives review of 77 studies, including 

22 those that show potential inflammatory effects, 
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1 the committee concluded there were there no 

2 toxicological concerns. Next slide.

3 In the United States, the Select 

4 Committee on GRAS Substances under the FDA 

5 concluded there was no evidence that undegraded 

6 carrageenan demonstrates a hazard to the public 

7 when it is used at current levels. The same report 

8 also noted that adverse events such as gut 

9 inflammation are species specific phenomena. 

10 Evidence indicating dietary carrageenan can induce 

11 ulceration of the cecum and proximal colon of the 

12 guinea pig does not appear to occur in the rat, the 

13 mouse, hamster, pig, squirrel monkey, or man. 

14 Next slide.

15 Carrageenan represents several unique 

16 and beneficial physical properties in its use in 

17 biomaterials and food supply. Carrageenan is an 

18 indispensable ingredient for organic foods, with 

19 organic formulations. It is cost-effective and 

20 enables functionality of that food that is not 

21 provided any other stabilizer and ensures products 

22 that are suitable and available for a wider range 
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1 of people. Next slide. In conclusion, the 

2 preponderance of scientific evidence, clinical 

3 evidence, and history of safe use indicate that 

4 carrageenan is safe for human consumption at all 

5 ages, including infants. Carrageenan is a unique 

6 ingredient in that it provides utility within a 

7 variety of food products. Lastly, the debate over 

8 carrageenan is used to highlight the necessity of 

9 critical rigor in the way laboratory research is 

10 conducted. Thank you very much for this 

11 opportunity. I'm right on time.

12 CHAIR FAVRE: Well, thank you. If we 

13 had prizes that I could send through the phone, I'd 

14 give you one. Thank you very much.

15 DR. CLEMENS: I appreciate your sense of 

16 humor.

17 CHAIR FAVRE: Thank you. We have a 

18 question from Tom Chapman for Mr. Clemens. And is 

19 it Professor, is it Dr. Clemens or Mr. Clemens?

20 DR. CLEMENS: It's Dr. Clemens. Mr. 

21 Clemens on the birth certificate, Dr. Clemens on 

22 the academic environment.
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1 CHAIR FAVRE: Great. Thank you. Thank 

2 you, Dr. Clemens.

3 DR. CLEMENS: You're welcome.

4 CHAIR FAVRE: We've got questions from 

5 Tom Chapman and then followed by Zea Sonnabend.

6 DR. CLEMENS: Sure.

7 CHAIR FAVRE: Tom, go ahead.

8 MEMBER CHAPMAN: Dr. Clemens, you've 

9 been quoted in the Daily Trojan, a USC publication, 

10 saying that, the only thing that organic food has 

11 added so far is the cost to your pocketbook. 

12 That's a very unsophisticated, narrowminded 

13 statement about this community that the NOSB 

14 represents. The new data on the organic label, how 

15 are we to know the information you just presented 

16 is not similarly selective and narrowminded?

17 DR. CLEMENS: Is that a statement or a 

18 question?

19 MEMBER CHAPMAN: That's a question.

20 DR. CLEMENS: Well, organic foods, as 

21 I've discussed, provides an opportunity for a lot 

22 of people to have other kinds of foods to their 
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1 liking. I've done extensive research in the area 

2 of nutritional value and food quality, and if you 

3 look at the spectrum of data, whether it be celery, 

4 lettuce, radishes, wine, it makes no difference, 

5 that there's a spectrum of inconsistency in terms 

6 of nutritional benefit in these kind of products. 

7 My international experience in the global market 

8 in terms of global nutrition that feed the 

9 malnourished people of the world, organic foods 

10 don't really have a significant role. My goal 

11 internationally is to provide excellent safe food 

12 that is affordable and accessible.

13 CHAIR FAVRE: Okay.

14 MEMBER CHAPMAN: Thank you.

15 CHAIR FAVRE: Thank you, Dr. Clemens. 

16 Zea, I believe you had a question next?

17 MEMBER SONNABEND: Yes. Can you hear 

18 me?

19 DR. CLEMENS: Yes, I can. Thank you.

20 MEMBER SONNABEND: This is Zea 

21 Sonnabend. My question is concerning, I'm sure 

22 you've read at least some of the literature and 
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1 perhaps also some of the other people's comments 

2 that we've received. So both the literature and 

3 the comments that we've received, there's a lot of 

4 critique of different scientific teams' research 

5 methodology. And so I'm wondering on your 

6 perspective of the validity of in vivo versus in 

7 vitro studies and studies of carrageenan that 

8 involve feeding in the drinking water versus 

9 binding to protein in feed. Do you think that some 

10 of those research methods are less valid than 

11 others?

12 DR. CLEMENS: I think you have to look 

13 at the composite and preponderance of evidence. 

14 Clearly, carrageenan is not administered through 

15 water, number one. Number two, the way it's 

16 metabolized, as you know, carrageenan is not 

17 absorbed. But importantly to all kinds of 

18 research, it's imperative that we understand the 

19 starting material. In many cases, the starting 

20 material is not fully characterized. In addition, 

21 some of the in vitro work, even the cell culture 

22 work, was compromised. And so, when you have 
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1 compromised data, it obviously compromises the 

2 concluding remarks. Therefore, if you don't 

3 include those kinds of data or those types of 

4 research in the proper perspective, you get a 

5 different conclusion.

6 CHAIR FAVRE: Okay. Thank you, Dr. 

7 Clemens. We appreciate your comments and your 

8 presentation. Any other questions for Dr. 

9 Clemens? Okay. Next up is Grace Gershuny and on 

10 deck is Patricia Di Gasbarro. And I apologize 

11 ahead of time for mispronunciations, we've got a 

12 couple of complicated ones for me. And just a note 

13 to folks on the line, Grace also has a presentation, 

14 which will be appearing on the webinar screen. 

15 Thank you.

16 MS. GERSHUNY: Can you hear me?

17 CHAIR FAVRE: Only very faintly. Can 

18 you speak up a little bit?

19 MS. GERSHUNY: Yes. Is this better? 

20 I'm on my headset.

21 CHAIR FAVRE: Yes, that's better.

22 MS. GERSHUNY: Okay. So I'll try not to 
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1 swallow the microphone. Thank you for listening 

2 to me again. I was here in Vermont in October and 

3 have now published the book that I gave out a 

4 reader's copy of. It's a much better condition 

5 than the very rough draft that you all on the NOSB 

6 saw. And so, I'm announcing the availability of 

7 the book and I want to point out the quote that's 

8 on the slide. This book is essential reading for 

9 anyone seeking to understand the events and ideas 

10 pivotal to the growth of the organic sector in the 

11 use, from Joe Smillie who wrote the forward to the 

12 book. And I hope that includes everybody here. 

13 So, I will make some copies available when I come 

14 down to Washington and bring some to the NOSB staff. 

15 And I will also be putting out an eBook very soon 

16 and will make those available to anybody on the 

17 NOSB. So, I wanted to just mention my affiliation. 

18 I am currently an instructor for Green Mountain 

19 College, masters of science in agricultural 

20 systems. I teach and practice about agriculture.

21 CHAIR FAVRE: Grace, we're losing you 

22 again, if you could speak up.
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1 MS. GERSHUNY: Am I still on?

2 CHAIR FAVRE: Yes, you're still on, but 

3 we can barely hear you.

4 MS. GERSHUNY: Okay. I'll try to speak 

5 up again. So, I will just make a couple of comments 

6 in support of the comments submitted by OTA, which 

7 includes especially the comments about nutrients, 

8 vitamins, and minerals, ancillary substances, and 

9 terminology of excluded methods. The other 

10 comments that I have have to do with biodegradable 

11 mulch, which Nicole Dehne spoke to very well. I 

12 have heard of at least one Vermont farmer who has 

13 declined to be certified so that he is able to use 

14 biodegradable use, which is ecologically much 

15 superior to the plastic stuff that you have to take 

16 off at the end of season and landfill.

17 And on the hydroponic/agroponic thing, 

18 I do respectfully disagree with my colleagues in 

19 Vermont, many of them. I do support agroponics to 

20 be considered organic and I suggest that it would 

21 be -- the problem could be solved by requiring that 

22 organic products of hydroponic or agroponic be 
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1 labeled as such so that consumers will know if they 

2 care about whether it's grown in water or soil that 

3 it is not grown in soil. So, those are my comments 

4 and I hope you will all check out the book. I 

5 appreciate the opportunity to speak to you all.

6 CHAIR FAVRE: Okay. Good timing. Does 

7 anybody have any questions for Grace? Okay. 

8 Thank you, Grace. Next up is Patricia Di Gasbarro, 

9 followed by Paul DeGrandpre. Thank you. 

10 Patricia?

11 MS. TUCKER: Hold on, we're trying to 

12 find Patricia on the phone list. What's the area 

13 code? 416? I don't have a 4, I go right from 3 

14 to 5, and she is not listed -- Patricia, are you 

15 on the line? Patricia, if you are there, but can't 

16 speak because you're muted, could you please go 

17 ahead and chat us to let us know you're there? We 

18 do not see you listed on the phone list and we can't 

19 find your phone number in the roster. Is she up 

20 here?

21 CHAIR FAVRE: Okay.

22 MS. TUCKER: We don't appear to have her.
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1 CHAIR FAVRE: Okay. Patricia, if we 

2 find you later, we'll try to work you in at the end. 

3 I'm sorry we missed this opportunity. Hopefully 

4 Paul DeGrandpre is on. Paul, if you're available, 

5 let's get you unmuted. And then next up after that 

6 is Joanne Tobacman.

7 MS. TUCKER: Hold on one second. I 

8 can't interact with him on the web, I can only 

9 interact with him by phone. What's his -- 541? 

10 I've got three 541s -- 2837? I don't have a 2837. 

11 Okay, I'm going to go ahead and unmute people from 

12 the 541 area code in the hope that it is --

13 MR. DeGRANDPRE: Hello?

14 MS. TUCKER: Can you hear us?

15 MR. DeGRANDPRE: We can hear you, can you 

16 hear us?

17 MS. TUCKER: Okay, go for it.

18 CHAIR FAVRE: Is this Paul?

19 MR. DeGRANDPRE: This is Paul.

20 CHAIR FAVRE: Great. Go ahead, Paul. 

21 Thank you.

22 MR. DeGRANDPRE: All right. Very good. 
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1 Well, my name is Paul DeGrandpre. I'm with 

2 PowderPure Company out here in lovely The Dalles, 

3 Oregon. I am joined by one of our co-owners and 

4 our chief science officer, Dr. Kerry Ringer. 

5 PowderPure is a certified organic fruit and 

6 vegetable dehydrator. We manufacture organic and 

7 conventional dry fruit and vegetable powders. We 

8 hope you have an opportunity to read the letter that 

9 we submitted. We tried to succinctly summarize 

10 our position as far as the silicon dioxide sunset 

11 issue goes.

12 Silicon dioxide is very important to us 

13 as greater than 95 percent of our organic and 

14 conventional fruit and vegetable powers require 

15 its anti-caking properties to maintain their 

16 condition in a flowable powdered food product. 

17 Silicon at less than the two percent allows us to 

18 produce a nearly pure organic fruit and vegetable 

19 powder product. The removal of silicon dioxide 

20 from the national list at 205.605 would virtually 

21 prevent us from supplying organic fruit and 

22 vegetable powders. Obviously, we're severely 
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1 affected, we don't know how many other companies 

2 would be similarly affected.

3 Our process allows us to produce these 

4 fruit and vegetable no carrier pure products. If 

5 silicon dioxide is removed, we'd have to dilute our 

6 pure fruit and vegetable products with a carrier 

7 at much higher amounts than two percent. We would 

8 need the 15 to 50 percent carrier as mentioned in 

9 our written comment. These are the levels that the 

10 rice hull people, the NuFlo people recommend for 

11 our products. Addition of a carrier or rice hulls, 

12 in this case, vastly changes the final powder's 

13 appearance, flavor, nutrition, solubility, and 

14 shelf stability.

15 The silicon dioxide at less than two 

16 percent dramatically increases the shelf stability 

17 of the fruit and vegetable powders behind what the 

18 rice hulls can accomplish at 15 percent. We're 

19 attempting to promote organics and healthy eating 

20 habits of increasing fruit and vegetable 

21 consumption and to promote fruit and vegetable 

22 preservation and prevention of post-harvest losses 
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1 through the use of our drying technology.

2 Our comment letter, there's a link in 

3 there to a 20 minute video of two of our highest 

4 volume products, the beet and carrot powder 

5 products, at three different storage temperatures 

6 comparing two percent AEROSIL, which is the brand 

7 of silicon dioxide we use, and NuFlo at two percent. 

8 And as you can see in the video, the NuFlo does not 

9 perform as well as the AEROSIL. One other concern 

10 we have is regarding the nomenclature of silicon 

11 dioxide.

12 Obviously, the organic community is 

13 very concerned with chemical use in the form of 

14 pesticides and fertilizers, particularly on 

15 organic products. If I talk about three different 

16 compounds, silicon dioxide, sodium chloride, and 

17 dihydrogen monoxide, it kind of creates a certain 

18 feeling in people's minds. If I call them sand, 

19 salt, and water, it kind of creates a different 

20 perspective in people's minds. And our position 

21 here at PowderPure is that we should leave sand on 

22 205.605 without any further restriction in use.
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1 MS. TUCKER: So that was the timer. I'm 

2 sorry, I don't think I hit the mute button quick 

3 enough for you guys to here that.

4 CHAIR FAVRE: Okay. Thank you, Paul. 

5 Does anybody have any questions for Paul? Okay. 

6 Seeing none, thank you, Paul. We appreciate your 

7 comments.

8 MR. DeGRANDPRE: Thank you.

9 CHAIR FAVRE: Next up is Joanne 

10 Tobacman, but it looks as though we are hunting for 

11 a phone number for her. Dr. Tobacman, if you're 

12 on the line, can you please chat in the window and 

13 let us know? We can't see a phone number for you.

14 MS. TUCKER: Joanne, we need your phone 

15 number to know who to unmute.

16 CHAIR FAVRE: Okay, we see you on here, 

17 but, Joanne, we need to see your phone number. The 

18 rest of the group can't see it, if you're concerned 

19 about that, but we can't unmute you for comments 

20 unless we have a phone number to figure out which 

21 one's you.

22 MS. TUCKER: Okay. Thank you. Just a 
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1 second, I'm going to find you. There you are. 

2 Okay, Joanne, you should now be unmuted.

3 DR. TOBACMAN: Can you hear me?

4 CHAIR FAVRE: Yes, we can. But before 

5 you get started, Joanne, I want to say that Madison 

6 Monty is on deck after Dr. Tobacman. Go ahead, Dr. 

7 Tobacman, thank you for being here.

8 DR. TOBACMAN: Thank you for this 

9 opportunity to comment. My collaborators and I 

10 are among many investigators who have shown the 

11 effects of carrageenan in cell culture and animal 

12 studies. PubMed from the National Library of 

13 Medicine list over 9,900 studies about carrageenan 

14 in recent decades. Now, in the majority of these 

15 studies, carrageenan has been used to cause 

16 inflammation since exposure to small amounts of 

17 carrageenan predictably causes inflammation in 

18 experiments in culture cells and in animals. 

19 Carrageenan induced inflammation has very often 

20 been used to identify mediators of inflammation and 

21 the effectiveness of anti-inflammatory 

22 medications.
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1 However, coincident with the ongoing 

2 use of carrageenan in the laboratory, carrageenan 

3 has been increasingly incorporated into food 

4 products, which are regularly consumed as part of 

5 a typical diet. And the use of carrageenan in 

6 these food products, and in organic food products 

7 in particular due to the increased safety 

8 associated with organic foods, is an ongoing 

9 serious concern. Inflammation contributes 

10 significantly to human diseases, including cancer, 

11 diabetes, arthritis, arteriosclerosis, and 

12 colitis. And we urge the NOSB to not certify 

13 products that contain carrageenan.

14 Carrageenan has been shown to activate 

15 inflammatory cascades through innate immune 

16 pathways and these pathways were first 

17 demonstrated in human immune cells involving the 

18 tolite receptor 4. There are also reactive oxygen 

19 species initiated inflammatory pathways. But 

20 tolite receptor 4 is part of the innate immune 

21 response in humans, it's not particular to any 

22 specific population of humans, but to all humans. 
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1 This is an innate immune receptor. And we believe 

2 that the impact of carrageenan is due to its 

3 fundamental chemical structure.

4 There's been a lot of talk over decades 

5 about distinguishing the low molecular weight 

6 carrageenan, often called poligeenan, versus the 

7 undegraded or higher molecular weight. However, 

8 the more accurate and informative way to think 

9 about carrageenan is to regard it as a 

10 disaccharide. It is a sulfated glycosaminoglycan 

11 similar to heparin or chondroitin sulfate and these 

12 have a fundamental disaccharide structure. In the 

13 case of carrageenan, these are galactose residues 

14 and they are linked in an alpha 1, 3 bond. And this 

15 is an immunogenic bond to humans.

16 So, many of the studies that have been 

17 done for decades in the laboratory animal models 

18 may not be entirely relevant to human disease, 

19 because humans and old world apes do not make this 

20 bond. And this is an immunogenic epitope to humans 

21 and the old world apes, so it stimulates these 

22 immune responses. And this fundamental 
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1 disaccharide unit is a part of carrageenan or the 

2 low molecular weight tail of undegraded 

3 carrageenan or undegraded carrageenan. It's like 

4 a string of pearls and the disaccharide unit is the 

5 pearl, and it can be of varying length.

6 And industry, I think, over decades has 

7 recognized that poligeenan does cause inflammation 

8 and ulcerations. And this is probably because of 

9 the stimulation of reactive oxygen species in the 

10 animals. But at this point in time, I think we need 

11 to recognize instead that this is a fundamental 

12 disaccharide unit and this is the source of harmful 

13 effects attributable to carrageenan. Thank you.

14 CHAIR FAVRE: Thank you, Dr. Tobacman. 

15 I believe Tom Chapman had a question for you.

16 DR. TOBACMAN: Yes?

17 CHAIR FAVRE: Tom, go ahead.

18 MEMBER CHAPMAN: Hi, Dr. Tobacman. So, 

19 in both your written comments and here you've 

20 spoken about the innate universal and fundamental 

21 effects of carrageenan on humans.

22 DR. TOBACMAN: Yes.
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1 MEMBER CHAPMAN: This is a particularly 

2 wide disagreement. Is it based on your study of 

3 cells from human origin? Is there an 

4 epidemiological study to support this statement?

5 DR. TOBACMAN: I'm sorry, I --

6 MEMBER CHAPMAN: Yes?

7 DR. TOBACMAN: I have a little trouble 

8 hearing everything that you said, I'm sorry. 

9 You'll have to repeat --

10 MEMBER CHAPMAN: I'll repeat it.

11 DR. TOBACMAN: Yes, please.

12 MEMBER CHAPMAN: Okay. Can you hear me 

13 now?

14 DR. TOBACMAN: Better, thank you.

15 MEMBER CHAPMAN: Okay. So in both your 

16 written and here, you spoke to the innate universal 

17 and fundamental effects of carrageenan on humans. 

18 And my question was, this seems to be a considerably 

19 wide statement, is this based on your study of cells 

20 from human origin? Was there an epidemiological 

21 study to support this statement? I had noticed 

22 that there wasn't a citation in the written 
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1 comments about this section. I'm curious if you 

2 had a citation for this statement.

3 DR. TOBACMAN: There's the presence of 

4 the anti-GALE antibody, which is highly prevalent 

5 in humans. And humans reject organs from most 

6 mammals, like pig transplants don't work. And 

7 this seems to be related to this epitope being 

8 present in the tissues of these animals. So, I 

9 don't -- in our studies with cells, we've looked 

10 at different enzymes that can break some of these 

11 disaccharide bonds and also the sulfatases and we 

12 do find a variation in the extent of inflammation 

13 that arises following these enzymatic treatments.

14 There are efforts to reduce the 

15 inflammatory response to this alpha 1, 3 GALE 

16 epitope to be better able to accept grafts from 

17 other species, but this seems to be something very 

18 fundamental. I did the notation that you perhaps 

19 saw that new world monkeys and old world monkeys 

20 differ even in the presence of this epitope. And 

21 there are fundamental biological differences 

22 between the two kinds of monkeys, the old world 
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1 monkeys and humans have opposable thumbs and we 

2 lack prehensile tails. So these are fundamental 

3 characteristics of humans.

4 And I don't know of any specific 

5 epidemiological study that you're looking for. 

6 The presence of the anti-GALE epitope is there. 

7 And there has also been the association with meat 

8 consumption and with tick bites, that they may also 

9 cause exposure to this epitope and some of the 

10 reactions may be a result of that. I don't know 

11 how to better answer than that information. Is 

12 there something else?

13 CHAIR FAVRE: Tom, did you have a 

14 follow-up?

15 MEMBER CHAPMAN: No, thank you, that's 

16 sufficient.

17 CHAIR FAVRE: Okay. I see Harold Austin 

18 has asked to ask a question, but, Harold, I don't 

19 know, it looks like you're not promoted, so Jenny, 

20 can you unmute him? Harold is a Board member, but 

21 we have him muted as part of a non-presenter. Do 

22 you have that as an option, Jenny?
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1 MS. TUCKER: I'm trying to find him on 

2 the list. What is his phone number?

3 CHAIR FAVRE: Harold, you might try to 

4 unmute yourself, I can't do it. I'm sorry.

5 MS. TUCKER: I'm unmuting everybody from 

6 509, there are only two of you. So, go ahead, 

7 Harold.

8 MEMBER AUSTIN: Okay. Can you hear me 

9 now?

10 CHAIR FAVRE: Yes, we can. Thank you.

11 MEMBER AUSTIN: Okay. A couple things. 

12 Dr. Tobacman, one of the things, looking at some 

13 of the studies that have been sent in, some of the 

14 comments, some of the reference points that we've 

15 been looking at and reviewing, and I was part of 

16 the original discussions that we had when I first 

17 came on to the Board back in 2012, looking at some 

18 of the reference points, like one of the studies 

19 by Dr. McKim, there seems to be a lot of difficulty 

20 by other researchers to try to replicate the 

21 findings that some of your research trials and 

22 studies have brought forth. Could you explain why 
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1 that might be?

2 DR. TOBACMAN: I think if you'll read 

3 careful the paper from Dr. McKim, et al, which I 

4 was asked to review at one point in time, it's 

5 really a flawed paper. They tried to put into 

6 these embryonic kidney cells and one might ask, how 

7 relevant are embryonic kidney cells anyway to adult 

8 human inflammation? But they tried to put this 

9 construct with a TLR4 and a couple of the other 

10 molecules that are required for the activation of 

11 the TLR4 inflammatory pathway, but they didn't 

12 really demonstrate the presence of the TLR4 in 

13 their cells. They just demonstrated a response to 

14 LPS. LPS may have induced that response by other 

15 mechanisms.

16 There has to be an extra-cellular 

17 domain of the TLR4 present for it to have an active 

18 inflammatory cascade, so there's nothing in that 

19 paper that's viable. It got published in Food and 

20 Chemical Toxicology, which seems to be a favorite 

21 source for publication of these industry reports 

22 that are attempting to refute work. It's not just 
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1 my work, there are other papers in the literature, 

2 9,900 papers, showing inflammatory effects of 

3 carrageenan. And it's not just my work that's 

4 showing TLR4, there are other papers, other 

5 descriptions in the literature. The activation of 

6 the tolite receptor pathway was reported to be 

7 associated with diabetes prior to our looking at 

8 it. And we find that there is activation of 

9 inflammatory pathways leading to glucose 

10 intolerance in association with carrageenan 

11 consumption.

12 The other critiques by industry of our 

13 work have involved using this NCM460 cell line, 

14 which was, when it was first reported, it was 

15 derived from normal human mucosa of a middle aged 

16 Hispanic male and then subsequently has been shown 

17 to be transformed. Most of the work that's done 

18 in cell culture is done with transformed cell 

19 lines, just because they continue to grow, so 

20 people are able to do experiments. We also did 

21 work with normal human colonic epithelial cells and 

22 many other cell lines. So, I don't know quite why 
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1 they feel justified in being so critical of the 

2 NCM460 cell line. It, like other cell lines, 

3 showed inflammation from carrageenan.

4 There was also criticism that the 

5 carrageenan we used contained dextrose. The 

6 carrageenan that was used in all of our experiments 

7 that we've reported was obtained from Sigma 

8 Chemical Company, a very old, established, 

9 reliable source of material. Original molecular 

10 weight was reported to be over a million, so we 

11 thought we were working with very high molecular 

12 undegraded carrageenan. And there was some 

13 suggestion that some of the Sigma carrageenan had 

14 dextrose in it. Well, that would only lower your 

15 exposure to the carrageenan, it wouldn't be a 

16 particularly negative fact if it had dextrose, it 

17 would just mean that less carrageenan was actually 

18 producing the effect that we saw than we had 

19 initially reported.

20 CHAIR FAVRE: Thank you, Dr. Tobacman. 

21 In the interest of getting on schedule, which we've 

22 already slipped a little bit, I'd ask Harold if we 
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1 can hold that question. I know this is a really 

2 complicated topic and we appreciate hearing from 

3 both sides to help us deliberate on this. Thank 

4 you very much. Next up is Madison Monty. And 

5 followed by that will be West Mathison. Madison, 

6 are you here with us?

7 MS. MONTY: Yes. Can you hear me?

8 CHAIR FAVRE: Yes, we can. Thank you.

9 MS. MONTY: Okay. Thank you. So, my 

10 name is Madison Monty and I am the policy advisor 

11 for the Northeast Organic Farming Association of 

12 Vermont. A little background, NOFA Vermont is one 

13 of the oldest organic farming associations in the 

14 country with around 1,200 members who are farmers, 

15 gardeners, and consumers, primarily in Vermont and 

16 other Northeastern states. I want to say I do 

17 appreciate the opportunity to comment to the Board 

18 today and I will be commenting on four topics, 

19 including hydroponics, excluded methods 

20 terminology, seed purity, and peracetic acid.

21 On hydroponics, which Nicole Dehne, our 

22 Certification Director, spoke about earlier, NOFA 
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1 Vermont and VOF believe the maintenance of organic 

2 material in the soil, along with the diverse 

3 populations of organisms that are essential to soil 

4 ecosystems are the foundation of organic farming. 

5 The certification of hydroponic systems as organic 

6 as currently sanctioned by the NOP fails to 

7 recognize the essential functions of complex soil 

8 ecosystems in organic production and the role of 

9 organic farmers as stewards of soil ecology.

10 Hydroponic systems reduce crop 

11 production to a simplified feeding system of a 

12 nutrient solution and an inert growing medium. 

13 Furthermore, the current inconsistencies among 

14 certifiers in regard to certifying hydroponic 

15 systems diminishes the value of the organic label. 

16 And as Nicole mentioned in her comments, our 

17 Senator Patrick Leahy issued a letter earlier this 

18 year to USDA Secretary Tom Vilsack strongly 

19 advising the NOP to issue a moratorium on new 

20 certifications for hydroponic systems and we 

21 strongly support the Senator's request and we urge 

22 the NOSB to reconfirm the Board's commitment to 
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1 soil-based production. And we look forward to 

2 hearing the further discussion about that at the 

3 meeting coming up.

4 And regarding excluded methods 

5 terminology, NOFA Vermont and VOF appreciate the 

6 NOSB's efforts to comprehensively examine the 

7 terminology and implications of excluded methods 

8 and to update the definitions that were established 

9 in 1995. Substantial advancements in 

10 agricultural biotechnology have and will continue 

11 to impact organic producers and challenge 

12 certification agencies that work hard to ensure the 

13 highest standards of production. So, we do 

14 promote the development of a comprehensive set of 

15 definitions of excluded methods terminology to 

16 ensure that the specific nature of new and evolving 

17 biotechnologies is fully captured, especially as 

18 it relates to organic production. So, we're glad 

19 to see the NOSB taking on that work.

20 With regard to seed purity, similarly, 

21 we support the NOSB's effort to continuously 

22 improve the processes, transparency, and data 
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1 collection around seed purity in order to prevent 

2 contamination from GE seed. We feel this is a very 

3 important issue and we appreciate that the NOSB is 

4 taking a thoughtful and deliberate approach in 

5 addressing it. And in addition, we support the 

6 NOSB's proposal to require a declaration of seed 

7 purity for non-organic seed and we hope that the 

8 Board's recommendations will encourage producers 

9 to source more organic seed going forward. So, 

10 we're happy to see that work and we support that.

11 Lastly, we do support the relisting of 

12 peracetic acid to the national list for all uses. 

13 Peracetic acid is a very important compound for 

14 organic vegetable and fruit growers in Vermont, as 

15 well as, I think, many other places. It's an 

16 alternative to chlorine for killing post-harvest 

17 disease organisms as well as potential human 

18 pathogens. It's a key ingredient in foliar 

19 disease control products, some of which are also 

20 used to treat tubers and other crops prior to 

21 planting to reduce plant pathogens. Peracetic 

22 acid is also an alternative to the use of copper 
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1 for managing late blight, which can be helpful in 

2 avoiding overuse of copper. So, just to 

3 reiterate, we do support the relisting of peracetic 

4 acid for all uses. And that's all I have. Thank 

5 you.

6 CHAIR FAVRE: Thank you, Madison. 

7 Anybody have any questions for Madison? Okay, I'm 

8 not seeing any. Thank you very much, Madison.

9 MS. MONTY: Okay. Thanks so much.

10 CHAIR FAVRE: Next up is West Mathison 

11 and then on deck is Margaret Scoles.

12 MR. MATHISON: All right. This is West 

13 Mathison. Can you guys hear me?

14 CHAIR FAVRE: Yes, we can. Thank you.

15 MR. MATHISON: Excellent. Well, thank 

16 you for letting me speak. I am a fifth generation 

17 apple and pear grower from the Washington State 

18 area. Our family grows and packs fruit and we sell 

19 about 2.5 million boxes. We've been doing 

20 organics for three decades. And we also go to 

21 market with 31 other organic apple and pear 

22 growers, most of which are smaller 
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1 multigenerational family farms. We are also 

2 conventional farmers of apples and pears and we see 

3 many positive benefits of using the product called 

4 SmartFresh. This is a natural ethylene blocker 

5 that improves the quality and extends the 

6 seasonality of many popular apple and pear 

7 varieties.

8 SmartFresh is a non-toxic material that 

9 is applied in a very low dose in airtight storage 

10 rooms, which has no impact, because it's not 

11 applied outside, to pollinators, birds, or water 

12 quality. It has an extremely short shelf life and 

13 biodegrades into the product found in nature. It 

14 leaves no detectable residues in exempt from 

15 tolerance studies. Stemlit is a long time user of 

16 SmartFresh and believes that the product is 

17 effective in these areas.

18 First, it improves tack out by around 

19 ten percent because the fruit naturally has less 

20 decay and because of the reduction in receptibility 

21 of ethylene and it basically reduced decay without 

22 any toxicity or fungicide. It also reduces the 
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1 need to repack or reduces shrink for apples and 

2 pears because it adds around ten days of shelf life. 

3 Also it improves freshness and flavor and we've 

4 seen between one to four pounds pressure 

5 improvement with the fruit coming out of storage 

6 maintaining the flavor and its crunchiness.

7 Also, SmartFresh is a great controller 

8 of storage scald, which is the top concern for 

9 storing organic apples and pears. Moreover, for 

10 smaller growers, it would allow them to store their 

11 organic products longer without the significant 

12 investment and expense of controlled atmosphere 

13 storage equipment. So a grower could use his or 

14 her regular storage cold room in conjunction with 

15 SmartFresh and add between 30 to 45 days of selling 

16 and marketing window. This would allow small 

17 organic growers to increase their production 

18 without the substantial construction costs of this 

19 sophisticated storage equipment.

20 We are certain that using SmartFresh on 

21 organic apples and pears would lengthen the 

22 marketing season for good quality organic fruit. 
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1 Increasing the marketing window also would 

2 motivate more growers to transition to organic 

3 because they could store more fruit longer. We 

4 also feel that using SmartFresh on organic apples 

5 and pears would create an increase in domestic 

6 supplies and reduce the pressure to import organic 

7 apples and pears in the United States from other 

8 countries that don't have as strong of programs.

9 Organic apple and pear growers would 

10 obviously -- by the approval of SmartFresh, would 

11 pave the way for growth in organic acreage in the 

12 future. And so, we strongly support the petition 

13 to approve SmartFresh for the use of organic apples 

14 and pears. I want to thank you for your time and 

15 consideration and will answer any questions.

16 CHAIR FAVRE: Thank you, West. Harold, 

17 I see you have a question. Go ahead, Harold.

18 MEMBER AUSTIN: Okay, am I unmuted, 

19 Tracy?

20 CHAIR FAVRE: Yes, you are.

21 MEMBER AUSTIN: Okay. West, thanks for 

22 the presentation. For those listening, 
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1 SmartFresh is currently petitioned before us and 

2 will be bringing it to the discussion in the fall 

3 meeting and it is 1-MCP. My question, West, for 

4 you, we know there's a lot of tools that 

5 conventional growers have or packing sheds have for 

6 storability, could you explain to us the difference 

7 that you see as a grower/packer in the quality and 

8 condition of the fruit from the early season 

9 closest to the harvesting time versus the stuff 

10 that you package and try to sell later in storage, 

11 that's coming out of the later storages? And the 

12 impact that 1-MCP would have on the condition of 

13 that later packed fruit?

14 MR. MATHISON: Yes. So before we had 

15 MCP, storing fruit really past December was really 

16 tricky and we saw a significant reduction in the 

17 pressure of the fruit and the flavor retention, 

18 just really was challenged before we had MCP. And 

19 so, since having SmartFresh, we've been able to 

20 effectively sell conventional products with really 

21 good pressures and flavors into the month of June 

22 and sometimes even July depending on the harvest 
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1 weather.

2 The gala variety, for example, really 

3 was very marginal in terms of our ability to sell 

4 it after the month of March. So you'd harvest it 

5 in September and you'd pretty much be done in March. 

6 Now, with the advent of MCP-1, allows us to 

7 naturally store that fruit without any fungicides 

8 or toxicity later in the season in extending that 

9 window. And again, further reducing the need to 

10 import product from other countries.

11 MEMBER AUSTIN: Thank you.

12 CHAIR FAVRE: Great. Thank you, West. 

13 Appreciate it. Next up is Margaret Scoles, 

14 followed by Angela Wartes on deck. Go ahead, 

15 Margaret, if you're unmuted.

16 MS. SCOLES: Can you hear me?

17 CHAIR FAVRE: Yes, we can.

18 MS. SCOLES: Great. Thank you for this 

19 opportunity to provide comment. The web meetings 

20 are great. The International Organic Inspectors 

21 Association is a membership association of organic 

22 inspectors. And I have not submitted these 
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1 comments in writing, Garth Kahl, a member of our 

2 Board of Directors will be at the D.C. meeting. I 

3 will try to keep my comments as brief as possible. 

4 First of all, on the discussion document on 

5 excluded methods terminology, great work. We're 

6 very supportive of the continued discussion and 

7 work on updating and clarifying excluded methods 

8 and we're pleased to see the inclusion of a 

9 definition of non-GMO that focuses on a process 

10 based definition. And we do think that you should 

11 include GE along with GMO when you're doing the 

12 terminology work.

13 We're very happy with the discussion 

14 document on seed purity. We think this was an 

15 essential first step and we commend you on the work 

16 that you have done. I have just a few comments and 

17 concerns. And first of all, we support others, 

18 others have suggested a seed purity task force to 

19 achieve feasible thresholds of GMO contamination 

20 and we support that. In general, we think that the 

21 organic seed requirement is currently not strong 

22 enough, even if it is written strongly in the 
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1 regulation. Commercial availability is being 

2 overused and possibly even abused.

3 Many organic farmers are choosing not 

4 to use organic seed instead of being part of a 

5 movement to increase the amount of organic seed. 

6 Particularly onerous to some of us inspectors is 

7 when we see contractors buying organic grain from 

8 growers and providing non-organic seed back to them 

9 for planting. And we realize there is NOP 

10 guidance, but something may need to be done, 

11 whether it's in guidance or in regulation we're not 

12 sure.

13 We do join the National Organic 

14 Coalition and the Wild Farm Alliance and others in 

15 suggesting to the CAC that you add to your work 

16 agenda eliminating the incentive to convert native 

17 ecosystems into organic crop production. We 

18 realize you can't do everything, conversion of 

19 native ecosystems for organic ecosystems is a 

20 problem and so we just want you not to stop thinking 

21 about it. For livestock proposals, we do support 

22 reduction of withdrawal times for procaine and 
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1 lidocaine. We think that's in the interest of 

2 animal welfare and a good move.

3 And in general, we support the work that 

4 you've done on parasiticides. Particularly we 

5 agree that wool and fleece from fiber bearing 

6 animals should be organic after an appropriate 

7 transition time. The current approach of last 

8 start of gestation is too large of a barrier to 

9 transition, it makes it almost impossible for fiber 

10 and lamb production to grow and it's not consistent 

11 with the approach to transitioning dairy. 

12 However, it doesn't seem correct that wool that's 

13 been treated with a synthetic parasiticide should 

14 be harvested as organic fiber. Wool clip grows for 

15 a whole year, so withdrawal time should be maybe 

16 addressed better for fiber harvest.

17 And our greater concern is the unequal 

18 application of emergency treatment. As 

19 inspectors, we see considerable difference in how 

20 emergency is determined. We are opposed to any 

21 changes that make it too easy for parasiticide use 

22 to become routine in an organic system. Perhaps 
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1 there's a need to define emergency use better or 

2 to describe the need to follow a decision making 

3 hierarchy as currently exists in the regulation for 

4 both crop and handling standards. As far as 

5 sunset, we support relisting copper sulfate on 601, 

6 although we do have some concerns about the need 

7 for continuing technical review on alternatives. 

8 And we support relisting peracetic acid and calcium 

9 chloride. Good luck with vitamins and minerals.

10 CHAIR FAVRE: We appreciate that. 

11 Anybody have any questions for Margaret? Okay, 

12 I'm not seeing any. Thank you, Margaret. Thanks 

13 for taking the time today. Next up is Angela 

14 Wartes and following that is Tyler Smith. Angela, 

15 are you unmuted?

16 MS. WARTES-KAHL: I believe I am. Can 

17 you hear me?

18 CHAIR FAVRE: Yes, we can. Thank you. 

19 Please go ahead.

20 MS. WARTES-KAHL: Thank you. Hello and 

21 good afternoon. My name is Angela Wartes-Kahl and 

22 I'm an organic farmer in Western Oregon at Common 
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1 Treasury Farm. Thank you for the opportunity to 

2 address the NOSB on the proposed annotation change 

3 for parasiticide use. I support the livestock 

4 community's proposal in its entirety. Common 

5 Treasury Farm has been certified organic since 

6 1993. Our operation is a small diversified 

7 vegetable, berry, and livestock operation.

8 I am also an advocate for local grown 

9 and produced fibers. I am working with Pacific 

10 Northwest chapter of Fibershed to build a 

11 processing facility for flax in Oregon and supply 

12 a growing consumer market looking for regionally 

13 grown fibers. I currently provide contract 

14 services to a certification agency to expand their 

15 fiber and textile program. I am also a certified 

16 wool classer, past student of the Design and Human 

17 Environment School at Oregon State University. I 

18 grow fiber flax on my farm and I raise a small flock 

19 of sheep. And I obviously do too much.

20 So by allowing the emergency use of 

21 parasiticides, a producer would be able to sell 

22 organic wool from animals that previously were only 
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1 classified as breeding stock, management problems 

2 would be considerably less burdensome, and more 

3 producers would stay with organic certification in 

4 the organic wool market in the U.S. and begin to 

5 supply GOT certified production in this country. 

6 Parasiticide use in organic farms is a last resort, 

7 but the ability to use these products without 

8 decertifying the fleece has the potential to 

9 completely transform the organic wool market.

10 Currently, organic sheep producers are 

11 not playing on a level playing field. If there was 

12 complete equivalency between organic standards 

13 concerning livestock the world over, we would 

14 better compete with New Zealand and Australian wool 

15 imports. The global organic textile standards, 

16 GOT, touches on many aspects of textile production, 

17 but they don't include the animal's care beyond use 

18 and the treatment of animals falls into the 

19 livestock rules for each country. Yet the 

20 resulting wool fiber can be certified GOT and 

21 imported around the world, even though one place 

22 allows dewormers and we do not.
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1 U.S. wool is very high quality and the 

2 consumers currently are asking for U.S. made 

3 products, especially now that organic mattresses 

4 are so popular. There is not enough organic wool 

5 in the U.S. to fill manufacturing orders because 

6 burdensome requirements make management so 

7 difficult. This proposed annotation change can 

8 have an immediate positive impact on organic 

9 textile production. I submitted written comments 

10 on the subject as well, in which I go into the 

11 details of managing a flock and the level of 

12 organization you need to meld organic practices 

13 with sheep shearing procedures, especially to give 

14 the NOSB members a window into our operations. 

15 Thank you so much for all your hard work and I 

16 appreciate any questions.

17 CHAIR FAVRE: Thank you, Angela. 

18 Anybody have any questions for Angela?

19 MEMBER RICHARDSON: Question from Jean.

20 CHAIR FAVRE: Yes, Jean, go ahead.

21 MEMBER RICHARDSON: Hi, Angela, and 

22 thank you. I read your written document and I also 
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1 just listened to Margaret Scoles make a comment 

2 that I would appreciate if you could help me to get 

3 to the bottom of, suggesting that there are 

4 parasiticide residues in wool and that you'd need 

5 to wait a year. Have you seen any documentation 

6 at all in your work that would indicate the residues

7 in a parasiticide for a short, long, extended 

8 period of time, et cetera, in wool from different 

9 parasiticides?

10 MS. WARTES-KAHL: Yes. That's a very 

11 good point. And depending on what climate region 

12 you're producing sheep in, it kind of depends on 

13 what kind of parasiticide you're going to use. In 

14 the case of Margaret's area in Montana, they have 

15 fine wool breeds and they might deal with a lot of 

16 skin ectoparasites that would require a drench or 

17 a dip to deal with or in the case of ivermectin, 

18 it would also have an impact on the ectoparasites 

19 as well if it was taken internally. But in our 

20 area, we don't use anything straight on the back 

21 of the sheep and so it doesn't have an impact on 

22 either the shearer's health or safety and then also 
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1 the resulting fleece, whether it would have a 

2 residue on it from the parasiticide.

3 There's been a number of studies, the 

4 most recent one that was brought to my attention, 

5 2003, about ivermectin residue inside the protein 

6 of the fiber of wool and how long that lasts or if 

7 it is detectable. The study was on Boer goats, not 

8 on sheep. And then also, it wasn't tested between 

9 maybe the secretions of sheep, which is going to 

10 be the lanolin, versus what was in the protein fiber 

11 of the actual wool.

12 So it's, I would say, pretty 

13 questionable, though the way the practice of 

14 shearing happens is that you shear once a year, 

15 sometimes two for long wools in our area, and a 

16 parasiticide application would be after the sheep 

17 was shorn. So it's like we shear them right before 

18 they lamb and then you probably give, if you need 

19 to, an emergency parasiticide later in the spring 

20 time, when the parasites are more prevalent, and 

21 then they have another whole year of growing the 

22 fleece out. So, I don't know if that answers your 
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1 questions specifically on the two differences 

2 there.

3 MEMBER RICHARDSON: Thank you, that was 

4 very helpful. I have also sent an email to 

5 Margaret asking her for any scientific references 

6 she has on this topic, because obviously I have 

7 searched all over the place for these and I don't 

8 get the same kind of comments that Margaret 

9 provided me with in terms of residues over an 

10 extended period of time. So, if you've got a 

11 specific scientific reference that you know about 

12 or a study, I sure would appreciate getting that 

13 before we get to vote on this next week. And you 

14 can send it --

15 MS. WARTES-KAHL: Yes.

16 MEMBER RICHARDSON: -- to the 

17 Subcommittee if you would be so kind as an addendum 

18 to your public comment. Thank you.

19 MS. WARTES-KAHL: Yes, I will. Thank 

20 you, Jean.

21 CHAIR FAVRE: Great. And, Angela, we do 

22 agree with you that you're trying to do entirely 
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1 too much. So thank you for being with us today. 

2 Next up is Tyler Smith and then on board after that 

3 is Marie Burcham. Tyler, are you with us?

4 MR. SMITH: Yes, I am.

5 CHAIR FAVRE: Great. We can hear you, 

6 please proceed.

7 MR. SMITH: Good afternoon. Again, my 

8 name is Tyler Smith. I'm the manager of the 

9 Consumer Reports Food Safety and Sustainability 

10 Center. My background is in environmental health 

11 science and risk assessment, as well as the 

12 development and evaluation of environmental health 

13 policy. As stated in our written comments, 

14 Consumer Reports does oppose the relisting of 

15 carrageenan by the NOSB due in part to concerns 

16 about the risks it may pose to human health. OFPA 

17 states clearly that a substance may be included on 

18 the national list only if its use would not be 

19 harmful to human health.

20 Now, there is an extensive literature 

21 on the carcinogenicity and toxicity of carrageenan 

22 at different molecular weights. And this 
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1 literature is discussed in depth both in our 

2 written comments and in the comments submitted by 

3 Dr. Tobacman, who you may know is a physician 

4 scientist at the University of Illinois Chicago. 

5 So while a recent technical report did focus on 

6 human health issues related to carrageenan, there 

7 were several considerations that were not 

8 addressed by the report.

9 And in particular, we note that because 

10 the evidence in toxicity is strongest for low 

11 molecular weight forms of carrageenan, many of the 

12 studies that were reviewed in the report focused 

13 on the average molecular weight of carrageenan 

14 that's added to food, or food grade carrageenan. 

15 A focus on the average molecular weight, however, 

16 does not consider whether a low molecular weight 

17 fraction is nonetheless present in carrageenan. 

18 Now, the TR does cite an analysis of 29 food grade 

19 carrageenan samples by Ito and colleagues and they 

20 found that none of the food grade carrageenan 

21 contained molecular weight fractions equivalent to 

22 poligeenan, which is the low molecular weight form, 
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1 at a detection limit of about five percent.

2 Now, the report did not discuss at all 

3 the adequacy of this detection limit. So, for 

4 example, if four to five percent of carrageenan 

5 added to food is low molecular weigh poligeenan or 

6 equivalent to poligeenan, then what is the cancer 

7 risk to consumers? We really are not able to 

8 assume that five percent is a small number 

9 toxicologically speaking and this question 

10 deserves further analysis before any decision to 

11 relist carrageenan is made by the NOSB. Really, 

12 at this point, the NOSB is not able to conclude that 

13 the use of carrageenan in food is not harmful to 

14 human health, which is the standard under organic 

15 law, and for this reason, Consumer Reports opposes 

16 the relisting of carrageenan. Thank you.

17 CHAIR FAVRE: Okay. Thank you, Tyler. 

18 Anybody have any questions for Tyler? Okay, I 

19 don't see any. Thank you, Tyler. We appreciate 

20 it.

21 MR. SMITH: Thank you.

22 CHAIR FAVRE: Next up is Marie Burcham. 
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1 Marie, are you with us?

2 MS. TUCKER: Yes. Hold on a second, 

3 we've got a number of folks from area code 608, so 

4 I need to unmute all of them, find out who it is 

5 that's speaking, and then mute the folks again. So 

6 give me just a moment.

7 CHAIR FAVRE: Okay. Just saw a chat 

8 from Marie that her number starts with 510.

9 MS. TUCKER: 510?

10 CHAIR FAVRE: Yes.

11 MS. TUCKER: Okay. That's different 

12 than what we had. Okay, Marie, can you hear us?

13 MS. BURCHAM: I can hear you, can you 

14 hear me?

15 CHAIR FAVRE: Yes, we can. Thank you, 

16 Marie.

17 MS. BURCHAM: Excellent.

18 CHAIR FAVRE: And before you start, next 

19 up after Marie is Kelly Damewood. Okay. Marie, 

20 go ahead.

21 MS. BURCHAM: Hi, good afternoon. My 

22 name is Marie Burcham and I'm a policy analyst with 
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1 the Cornucopia Institute. I would like to speak 

2 about the policy and procedures manual rewrite. 

3 In general, Cornucopia opposes this rewrite 

4 because of the manner in which it was done. The 

5 PPM provides a framework to all Board activities 

6 with respect for the process already established 

7 for making changes to this manual. Cornucopia has 

8 submitted detailed comments on these issues and 

9 we've also released a side-by-side comparison 

10 chart, which we hope will assist the Board and the 

11 public in the analysis of the draft manual. The 

12 NOP did not make it easy for the NOSB members or 

13 the public to understand and compare the major 

14 changes they were proposing.

15 I would like to speak briefly about the 

16 specific concerns with the hope that other people 

17 will talk generally about these issues. First, 

18 public access to the documents should not be 

19 delayed or discounted. The Federal Advisory 

20 Committee Act dictates that many documents, 

21 including working papers, are made available to 

22 public inspection. There is language in the 
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1 rewritten manual that appears to conflict with FACA 

2 directly by limiting public access to this kind of 

3 information.

4 Second, the manual is vague and lacks 

5 clear conflict of interest policies. If this 

6 manual is updated, it's important that conflict of 

7 interests are well managed to maintain the public 

8 trust. Specific to conflicts of interest, both 

9 contractors and individual scientists and 

10 technical experts that conduct the reviews for 

11 materials should be named. That's so that full 

12 conflict checks can be performed at this stage as 

13 well. The Organic Foods Production Act 

14 specifically gives NOSB the power to contract for 

15 material review directly and not through the NOP.

16 Third, compared to the current PPM, the 

17 new draft manual diminishes the NOSB's ability to 

18 establish their own procedures. If the NOSB's 

19 duties are constricted by NOP management, it will 

20 infringe upon the Board's ability to act as a link 

21 to the organic community and defend the integrity 

22 of organics. Fourth, the time available for 
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1 public comment on potential changes to the national 

2 list was cut in half, from 60 days to 30 days. This 

3 time is not sufficient for a well developed public 

4 comment.

5 Fifth, the Board's ability to control 

6 their own agenda is compromised by this rewrite. 

7 Congress intended that the NOSB remain an 

8 independent body. The Board cannot advise the 

9 Secretary properly if its authority to develop a 

10 work plan and agenda or create committees and 

11 procedures is diminished or denied. The language 

12 giving NOSB control of their own agenda must be 

13 restored to maintain a proper balance if this 

14 rewrite goes through. These issues do not come at 

15 the cost of collaboration, but rather maintain the 

16 intended purpose of the NOSB as described in OFPA.

17 Finally, there are many fatal 

18 ambiguities, undefined terms, and inconsistencies 

19 found throughout the new draft. These issues, 

20 both big and small, only serve to frustrate the 

21 Board and the public. Our submitted comments go 

22 into more detail and I hope that they will help you 
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1 in making this decision. I'll close by saying, if 

2 the manual does need to be updated, it should be 

3 directed by the NOSB with input from the public. 

4 Thank you very much. I'm happy to answer specific 

5 questions and if you have future questions about 

6 our comments or the chart, I would love to front 

7 those as well.

8 CHAIR FAVRE: Thank you, Marie. I see 

9 Tom Chapman has a question. Tom, go ahead.

10 MEMBER CHAPMAN: Yes. First of all, 

11 thank you for your detailed comments on the PPM and 

12 comments here, with the limits on time, I won't be 

13 able to dig into every comment. But I want to talk 

14 to you about, let's go with agenda setting. Are 

15 you aware of any requirements in the OFPA that 

16 specifically speaks to agenda?

17 MS. BURCHAM: I don't think there's 

18 anything specific to agendas as named, but the NOSB 

19 is supposed to direct their own schedule and review 

20 because they're the ones that are supposed to be 

21 advising the Secretary. It's not supposed to be 

22 a relationship mediated through NOP necessarily. 
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1 And --

2 MEMBER CHAPMAN: Is that on the 

3 information off our FACA or is that just opinion?

4 MS. BURCHAM: That's based on a 

5 publication and I don't have that right in front 

6 of me, but it is in our comments and I can also give 

7 it to you afterward if that would be helpful.

8 MEMBER CHAPMAN: Yes, it would be. I'm 

9 looking at a section of FACA that states in Section 

10 10(f), Advisory committees shall not hold any 

11 meetings except at the call of, or with the advance 

12 approval of, a designated officer or employee of 

13 the Federal Government, and in the case of advisory 

14 committees, other than Presidential advisory 

15 committees, with an agenda approved by such officer 

16 or employee. It's stating that agendas need to be 

17 approved at the point of FACA by government 

18 employees. Can you speak to that?

19 MS. BURCHAM: Approval is not creation. 

20 So, the creation of your own work agenda just means 

21 that the NOSB is in control of creating that work 

22 agenda, directing their own procedures, whereas 
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1 approval is a check mark or a review once that work 

2 agenda has been created by the NOSB.

3 MEMBER CHAPMAN: Okay. Let me hear you 

4 correctly, you do agree that FACA requires 

5 government approval of the NOSB agenda, is that 

6 correct?

7 MS. BURCHAM: It sounds like it, yes.

8 MEMBER CHAPMAN: Thank you.

9 MS. BURCHAM: Again, I went into more 

10 detail in our comments and there should be full 

11 citations to everything.

12 MEMBER CHAPMAN: Definitely, you 

13 definitely did and this format only allows for 

14 certain question and answers. I appreciate your 

15 time.

16 MS. BURCHAM: Right.

17 MEMBER CHAPMAN: Thank you very much.

18 MS. BURCHAM: You're welcome. Thank 

19 you.

20 CHAIR FAVRE: Thank you, Marie. Next up 

21 is Kelly Damewood and following that on deck is 

22 Helen Kees. Kelly, are you with us?
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1 MS. DAMEWOOD: Yes. Can you hear me?

2 CHAIR FAVRE: Yes, we can. Please go 

3 ahead.

4 MS. DAMEWOOD: Okay, great. Thanks. 

5 So thank you NOSB members for the opportunity to 

6 provide public comment today. I'm Kelly Damewood, 

7 policy director at CCOF, California Certified 

8 Organic Farmers. We are a nonprofit organization 

9 that advances organic agriculture through 

10 certification, education, advocacy, and 

11 promotion. We're based in Santa Cruz, California 

12 and represent more than 3,000 certified organic 

13 members in 42 different states and three countries.

14 So, my comments today are to express 

15 strong support for NOSB's ongoing work related to 

16 GMOs, including updating the excluded methods 

17 terminology and determining next steps for seed 

18 purity guidance. This work is essential and must 

19 remain a top priority for NOSB moving forward. GMO 

20 technology continues to rapidly evolve and expand. 

21 It's essentially unchecked and poorly regulated at 

22 best. Therefore, the organic certification 
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1 process must also evolve. Organic producers need 

2 clear guidance and every tool available to prevent 

3 risk of inadvertent contamination.

4 The growing presence of GMO seed in 

5 crops, the complicated terminology and evolving 

6 technology is certainly overwhelming. Yet, we 

7 cannot let our inability to tackle every single 

8 aspect of this issue now really cripple and prevent 

9 us from moving forward and developing logical 

10 certification tools that address the highest areas 

11 of concern. So, to that effect, CCOF supports the 

12 establishment of a USDA Seed Purity Task Force. 

13 That task force should take immediate action to 

14 address the use of non-organic seed with GMO 

15 equivalents, otherwise known as at-risk seeds. 

16 These are an obvious source of contamination.

17 NOSB should move forward on this 

18 discrete area of risk and help develop 

19 recommendations for guidance that would allow 

20 certifiers to implement consistent verification 

21 processes to ensure at-risk seed is non-GMO. 

22 Certifiers can and do test for GMOs under the 
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1 mandated residue testing requirements and based on 

2 test results, certifiers must investigate down the 

3 supply chain and trace the cause of contamination. 

4 This investigatory authority and traceability 

5 means that organic can and does address sources of 

6 contamination now.

7 And with further guidance and proactive 

8 steps, organic certification processes can 

9 strengthen oversight and prevention of inadvertent 

10 GMO presence on organic product and ensure that 

11 organic consumers are receiving the non-GMO food 

12 that they expect and demand. The CCOF supports the 

13 excluded methods proposal and it urges NOSB to move 

14 forward on seed purity and excluded methods 

15 recommendations. So, thank you for your time and 

16 consideration of CCOF's comments.

17 CHAIR FAVRE: Great. Thank you, Kelly. 

18 Anybody have any questions for Kelly? Okay, I 

19 don't see any. Thank you very much, Kelly.

20 MS. DAMEWOOD: Thank you.

21 CHAIR FAVRE: Next up is Helen Kees and 

22 we've got Kristen Walker on deck. Helen, are you 
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1 with us?

2 MS. TUCKER: We've got a number of 

3 callers from area code 608, which is what I believe 

4 Helen is calling from. So I've now unmuted anybody 

5 in the area code of 608. So, Helen, are you with 

6 us?

7 MR. CASTEL: This is Mark Castel. Helen 

8 is in the 715 area code.

9 MS. TUCKER: Oh, okay. We don't have 

10 anyone from the 715 area code. Yes, she gave us 

11 a 608 number and that's why I unmuted all the 608s. 

12 I don't have a 715 area code caller.

13 CHAIR FAVRE: Okay. We'll come back. 

14 Helen, if you are on the line and we've missed you, 

15 we'll try to fit you in at the end. I'll check, 

16 we've got a couple of people that we might have to 

17 do that to. So, next up is Kristen Walker and then 

18 we have Amber Pool on deck. Kristen, are you with 

19 us?

20 MS. TUCKER: Hold on, Tracy. We've got 

21 to find her.

22 CHAIR FAVRE: Okay. Just give us a 
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1 moment everybody.

2 MS. TUCKER: I've got a 267, let's see 

3 if she's listed on it as a name. I don't have any 

4 Ks, is she up above? It doesn't look like we have 

5 a Kristen on the line, Tracy. We're looking 

6 through all the various ways we can find somebody 

7 and not finding her. Again, the area code was 

8 what, 269? I've got a 267.

9 CHAIR FAVRE: Okay. Kristen, if you are 

10 on the line, you can send us a message in the chat 

11 box. If not, we'll try to come back to you if you 

12 are on the line later. So, Amber, that puts you 

13 in the hot seat a little early if you're with us. 

14 Amber?

15 MS. TUCKER: I've got to find Amber too. 

16 Just a second.

17 CHAIR FAVRE: Okay. Now we're rolling 

18 ahead, so everybody be patient with us as we handle 

19 the logistics of this. Again, I have a mental 

20 picture of them running around the room unmuting.

21 MS. TUCKER: Okay. Amber is what area 

22 code, 831? Oh, I've got a couple of 831s, so that's 
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1 good. There's hope here. Amber, are you there?

2 MS. POOL: Hi, I'm here. Can you hear 

3 me?

4 CHAIR FAVRE: Yes, we can. Great.

5 MS. POOL: Okay.

6 CHAIR FAVRE: And then just as fair 

7 warning, next up Christine Rich is on deck. Go 

8 ahead, Amber. Thank you.

9 MS. POOL: Okay. Hi, this is Amber 

10 Pool. I've been an organic certification 

11 specialist for CCOF for ten years in the farm 

12 department. And today I'm going to talk about the 

13 sunset of copper sulfate. And we have 228 CCOF 

14 members who have copper sulfate on their organic 

15 system plan. It's a critical input for aquatic 

16 feed and rice producers and they use it to manage 

17 fairy shrimp and scum disease that interferes with 

18 crop germination. We see that the growers don't 

19 need to use this product every year, but there are 

20 certain situations where this is an essential tool 

21 for producing an organic rice crop.

22 We reached out to all of our rice 
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1 producers who are using copper sulfate and they 

2 told us that they would not be able to produce 

3 organic rice because there is no viable 

4 alternative. Each year at their inspection, the 

5 growers have to demonstrate that they are not over 

6 applying copper and we've never seen evidence of 

7 over applications and we haven't seen copper 

8 accumulation in the water or the soil. And this 

9 is due to the high cost of these copper materials, 

10 in addition to EPA regulations and water 

11 regulations. And, with that, I'm complete and I'm 

12 happy to answer any questions.

13 CHAIR FAVRE: Okay. Do we have any 

14 questions for Amber? Okay, Amber, I don't see any, 

15 so thank you for taking the time to join us today.

16 MS. POOL: Thank you.

17 CHAIR FAVRE: Next up is Christine Rich. 

18 Christine, are you with us yet?

19 MS. TUCKER: We don't have Christine's 

20 area code showing up. She's area code 209. I 

21 don't have her listed as a name. So, I don't either 

22 have a name or a number for her.
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1 CHAIR FAVRE: Okay.

2 MS. TUCKER: If you hold on one -- what 

3 I'm trying to do now is, because it seems like 

4 people are using different numbers than they signed 

5 up with, we're trying to reach out to them in 

6 advance to see if we can figure out what number 

7 they're calling from, but I don't even see her on 

8 the -- she's not even on the web version. So I 

9 don't think we have her.

10 CHAIR FAVRE: Okay. Well, then if we 

11 don't have Christine, Christine, if you join us, 

12 if you'll send in a message to the chat box, we'll 

13 try to work you in at the end if we have time. The 

14 next up on the list is Amber King. Jenny, have we 

15 found Amber?

16 MS. TUCKER: Give me a second, I've got 

17 to find her too.

18 CHAIR FAVRE: Okay.

19 MS. TUCKER: Amber, she's not up there. 

20 What's the area code, 907? We don't have her area 

21 code and we don't have her listed by name. So if 

22 she's calling in, she might be calling in from a 
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1 different number. Let me check one other place to 

2 see if she's on us with chat. Amber King. Hold 

3 on. Amber King, there she is. Let's see if we can 

4 get her to send her -- just a sec.

5 If you are on deck for a future call, 

6 to speak in the future, if you could please send 

7 us your phone number. We're finding that most 

8 people are actually dialing from different numbers 

9 than they gave us, which is making it really hard 

10 to find you. So if you are on deck to give public 

11 comments, please go ahead and send us your phone 

12 number in the chat box. The only people that will 

13 see it are the leads here at the NOP and the NOSB 

14 Board members, so we're not releasing your phone 

15 number, but we need it to figure out who you are 

16 so we can unmute you.

17 CHAIR FAVRE: Okay. In the interest of 

18 staying on schedule, Amber, I know that you're 

19 online, but we don't have a phone number for you, 

20 we'll try to work you in at the end. I see next 

21 up is Peter Pitts. And Peter just chatted in that 

22 he's here on VOIP. So, Jenny, I'm not sure 
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1 exactly, I guess maybe you had the opportunity to 

2 unmute him there?

3 MS. TUCKER: Yes, he is now unmuted. 

4 So, Peter --

5 CHAIR FAVRE: Okay.

6 MS. TUCKER: -- you can go ahead.

7 CHAIR FAVRE: Peter, are you here?

8 MR. PITTS: Can you hear me? I am, can 

9 you hear me?

10 CHAIR FAVRE: Yes, we can.

11 MR. PITTS: Excellent, thank you.

12 CHAIR FAVRE: And before you get 

13 started, let me just warn everybody that Kelly 

14 Taveras is on deck after Peter. So, go ahead, 

15 Peter. Thank you.

16 MR. PITTS: Thank you. I'm the 

17 president of the Center for Medicine in the Public 

18 Interest and a former associate commissioner at the 

19 U.S. Food and Drug Administration. I'd like to 

20 thank all the folks at NOSB for taking the time to 

21 hear comments from the public about whether USDA 

22 should continue listing carrageenan as a 
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1 nonsynthetic ingredient for use in organic 

2 products and I'd like to add my thoughts to the 

3 discussion.

4 In my former capacity at the FDA, I was 

5 responsible for convening diverse stakeholders in 

6 the health and wellness sectors to evaluate 

7 critical health challenges including obesity and 

8 provide public policy recommendations. And a 

9 fundamental part of this effort was offering 

10 recommendations grounded in a science based 

11 approach, that means reviewing all the facts before 

12 us and giving weight to peer reviewed research that 

13 has been replicated many times over.

14 With the democratization of the 

15 internet, it's becoming increasingly difficult to 

16 differentiate between sound science and what has 

17 been dubbed junk science or pseudoscience. And 

18 the shifting landscape has changed the way 

19 consumers get their information and make informed 

20 decisions about a variety of issues, especially 

21 ones with an overwhelming amount of research that 

22 can be found online. That increased exposure 
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1 means that it's harder for consumers to determine 

2 fact from fiction.

3 In some cases, third party 

4 organizations and scientists with dubious research

5 have emerged to fill the gap and find creative ways 

6 to profit from this misinformation and confusion. 

7 And I think this trend is not only concerning, it's 

8 dangerous. In the case of carrageenan, there are 

9 numerous studies that have proven time and again 

10 that it's safe to use, offers nutritional benefits, 

11 and is an important thickener and stabilizer for 

12 a wide ranging consumer product group.

13 Equally as important is that there is 

14 a scientific consensus among leading health and 

15 international organizations, including my former 

16 agency the FDA, the United Nations Food and 

17 Agricultural Organization, the WHO, and regulatory 

18 agencies in various countries and what's more, is 

19 that carrageenan has been around for centuries and 

20 it's been cultivated and consumed by different 

21 cultures in many countries around the world. So, 

22 against this backdrop, it's important to 
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1 understand the agenda of those who are advocating 

2 for carrageenan's sunset. With only one flawed 

3 scientific study to back up their claim, the 

4 question is, what's driving these truths? Is it 

5 science or is it something else? And what do 

6 people really stand to gain?

7 I think that the vaccine debate is a 

8 cautionary tale for us to understand. Up until 

9 recently, it's been a scientifically accepted 

10 principle that we should vaccinate our children to 

11 protect them from life threatening viruses once the 

12 scourge of health and now really absent for the 

13 current generation. But due to unsubstantiated 

14 claims that vaccines can cause autism, we've seen 

15 a growing trend of parents who refuse to vaccinate 

16 their children. And that's really frightening.

17 Now while the impact of the decision in 

18 front of you will not be life threatening, it would 

19 negatively impact the tens of thousands of farmers 

20 whose livelihoods depend on harvesting this 

21 ingredient, carrageenan. It also would impact our 

22 food system, making the texture of many products 
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1 less appealing and leading to more food waste as 

2 certain products would have much shorter shelf 

3 lives. Changing carrageenan's designation would 

4 reverse decades of added benefits to consumers. 

5 So, having once in a position similar to yours 

6 today, I appreciate the challenge you have before 

7 you and I ask you to lead with sound science. 

8 Please, don't let politics or hidden agendas 

9 distract you from the task at hand. Thank you for 

10 your time. I'm happy to answer any questions.

11 CHAIR FAVRE: Thank you, Peter. Harold 

12 Austin has a question for you. Go ahead, Harold.

13 MEMBER AUSTIN: Thanks, Tracy. Peter, 

14 hearing some of the testimonies today and looking 

15 at a lot of the comments that are submitted to us, 

16 there seems to be this continual overlap in misuse 

17 of the characterization of carrageenan and 

18 poligeenan. Could you explain the -- are you able 

19 to explain the difference between those two briefly 

20 for us so that we have a better understanding of 

21 what carrageenan is and what poligeenan is?

22 MR. PITTS: No, that's not my field. My 
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1 field is public policy and scientific accuracy. 

2 And the comment I was trying to offer really is to 

3 stick to the science, you guys are the experts. 

4 Science is rarely a black and white, binary, yes/no 

5 proposition, but to weigh all the science in front 

6 of you that you feel is relevant based on your 

7 testimony and the public's testimony, both written 

8 and oral, and then make a wise decision.

9 MEMBER AUSTIN: Okay. All right. 

10 Thank you.

11 CHAIR FAVRE: Any other questions for 

12 Peter? Okay, thank you very much for your 

13 comments, Peter.

14 MR. PITTS: Thank you.

15 CHAIR FAVRE: Next up is Kelly Taveras 

16 and on deck is Ryan Howard. Kelly --

17 MS. TUCKER: Hold on.

18 CHAIR FAVRE: -- are you with us?

19 MS. TUCKER: Hold on. Okay. Try, 

20 Kelly.

21 MS. TAVERAS: Hi, I'm here.

22 MS. TUCKER: Okay, thank you.
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1 CHAIR FAVRE: Yes, we can hear you, 

2 Kelly. Please go ahead.

3 MS. TAVERAS: Great. Good afternoon. 

4 My name is Kelly Taveras and I serve as the 

5 associate director of digital engagement for the 

6 Organic Trade Association. On behalf of OTA, I'd 

7 like to welcome the new Board members and thank you 

8 for beginning the five year journey of critical and 

9 greatly appreciated service to the organic sector. 

10 My colleagues will speak on specific agenda topics 

11 at the in-person meeting and you have our detailed 

12 written comments, so my remarks will focus on an 

13 introduction to OTA's membership for new Board 

14 members, our NOSB comment process, and our sunset 

15 material review work.

16 To begin, I'd like to thank NOSB and the 

17 National Organic Program for offering this virtual 

18 opportunity for public comment preceding the 

19 in-person meeting. Increasing accessibility to 

20 this process is a big step forward and I'm very 

21 excited to be taking advantage of the option. I 

22 would also like to mention that OTA has published 
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1 our NOSB resource booklet in advance of the spring 

2 meeting, and one of the feature articles in this 

3 edition highlights the work of the National List 

4 Innovation Working Group to find an organic 

5 alternative to celery powder.

6 The process the working group is 

7 following also informed the introduction to the 

8 resource booklet and the model that we've created 

9 to help guide the organic sector in its efforts to 

10 develop organic and natural alternatives to 

11 national list materials. Also, be sure to check 

12 out the booklet for summaries of OTA comments and 

13 a deeper dive into historical perspectives on the 

14 national list.

15 So, a bit about the Organic Trade 

16 Association. One of OTA's strongest assets as an 

17 organization is the diversity and breadth of our 

18 membership. Unlike many trade associations, OTA 

19 is uniquely structured to include the full value 

20 chain for the organic industry, ensuring that all 

21 segments from farm to marketplace have a strong 

22 voice within the organization. OTA brings farmers 
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1 and growers, ingredient suppliers, processors, 

2 manufacturers, distributors, retailers, and many 

3 others together to promote and protect the growing 

4 organic sector.

5 We represent over 8,500 business in all 

6 50 states and half of OTA members are small business 

7 reporting less than $1 million in organic sales per 

8 year. OTA members are represented either through 

9 direct membership or through strategic 

10 partnerships with regional organic producer 

11 organizations across the U.S. through our Farmer's 

12 Advisory Council. OTA's membership is completely 

13 transparent as well, so if you visit ota.com, 

14 you'll see clearly stated information on how to 

15 become a member, what the benefits of membership 

16 are, and even more importantly, how we engage 

17 members in our advocacy work.

18 OTA members are proud to be a part of 

19 the Association and the OTA member list is and 

20 always has been open to the public. Our membership 

21 is also notably governed by a democratically 

22 elected Board of Directors, ensuring that we are 
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1 accurately representing our stakeholders. The 

2 comments that OTA submitted to NOSB are on behalf 

3 of this membership. In order to do this, our 

4 regulatory staff carries out an extensive process 

5 of member engagement so that we can understand how 

6 NOSB recommendations will impact certified farmers 

7 and handlers on a day-to-day basis.

8 The feedback collected informs our 

9 draft comments, which are distributed to the 

10 membership at least a week in advance of comment 

11 deadlines, and then members are provided with an 

12 opportunity to weigh in and inform any changes that 

13 may be needed prior to our final submission. To 

14 help facilitate a thorough comment and review 

15 process for 2018 sunset materials, we created an 

16 electronic survey for each individual input under 

17 review. The surveys are confidential, user 

18 friendly, available to every NOP certificate 

19 holder, and include seven to ten questions that 

20 specifically address the necessity or centrality 

21 of the national list input under review.

22 So, you have our written comments, 
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1 which include all of the survey responses we 

2 received to date, and we're proud to have collected 

3 a total of 52 unique responses from organic 

4 businesses across the U.S. and we will continue to 

5 collect responses to inform the vote that will take 

6 place in the fall. Thank you to the Board for your 

7 hard work and commitment to furthering organics. 

8 And that's it for me.

9 CHAIR FAVRE: Thank you, Kelly. 

10 Anybody have questions for Kelly? Okay, I'm not 

11 seeing any. Thank you for your comments, Kelly.

12 MS. TAVERAS: Thank you.

13 CHAIR FAVRE: Next up is Ryan Howard, 

14 with Myra Weiner on deck. Ryan, are you with us?

15 MR. HOWARD: I am. Can you hear me okay?

16 CHAIR FAVRE: Yes, we can. Please go 

17 ahead.

18 MR. HOWARD: Great. I want to thank the 

19 Organic Board for hearing my comments. So my name 

20 is Ryan Howard. I'm president of Chicago Vegan 

21 Foods the company who manufactures Dandie's Vegan 

22 Marshmallows and a 23 year vegan. To me, my 
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1 comments I feel are kind of are superfluous to all 

2 the scientific support of carrageenan safety, but 

3 I just wanted to provide a comment on my perspective 

4 as a long time vegan and as an industry person, a 

5 food manufacturer.

6 So, by default, being vegan kind of 

7 means that I eat a lot of organic foods, maybe even 

8 up to 50 percent, so a lot of the foods that made 

9 it easy for me to be vegan and for newcomers to stay 

10 vegan, like vegan cheeses, soy milk, mock meats, 

11 they use carrageenan and they do a really good job 

12 at mimicking the original product. That's 

13 important to me as a vegan because it saves animals' 

14 lives. Now, as someone who likes food, food 

15 product quality I feel has suffered because of this 

16 like climate change denier style fanatical 

17 carrageenan attacks.

18 I get these comments and I know other 

19 companies get these comments, they're being 

20 bullied and a lot of these companies are tired of 

21 hearing things like carrageenan causes cancer and 

22 carrageenan is poison, and so a lot of companies 
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1 have changed their ingredients. And it's coming 

2 from a very, very vocal minority, but to the rest 

3 of us who don't care about that and don't feel the 

4 same way, we just care about the product and the 

5 product quality has suffered greatly with a lot of 

6 these organic and natural products. To the point 

7 which I have actually stopped buying certain 

8 brands.

9 I don't like vegan coffee creamers that 

10 just dilutes my coffee and I don't like soy milk 

11 that's not smooth. It sounds cool, but it doesn't 

12 have a good texture on soy milk. So I just feel 

13 like I'm not alone here, but the people who are 

14 really, really screaming are not my friends and I 

15 and people I know. As a manufacturer, carrageenan 

16 is important to me because I'm looking to make 

17 natural vegan analog products that are very close 

18 to or better than their conventional counterparts. 

19 Carrageenan is used at very low levels and it does 

20 a great job.

21 So, one of my reasons for talking today 

22 is because I really want to develop an organic vegan 
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1 marshmallow, but I'm really concerned that if I 

2 spend money and time and R&D resources on 

3 developing one, that it's potentially going to be 

4 removed from the acceptable list in the new future. 

5 And I worry about like if carrageenan, which is a 

6 product used at very low use levels, is removed from 

7 the list that other ingredients could be removed 

8 as well. So, I mean, I see on the International 

9 Agency for Research on Cancers Class 2B carcinogen 

10 list, we've got coffee and pickled vegetables. 

11 And there's probably way more exposure to coffee 

12 and pickles than carrageenan in a handful of 

13 products. So, that's my comment. And thanks a 

14 lot everybody.

15 CHAIR FAVRE: Okay. Thank you very 

16 much, Ryan. Anybody have any questions? Yes, 

17 Zea, I see you have a question for Ryan. Go ahead.

18 MEMBER SONNABEND: Yes, thank you. In 

19 your situation, which non-vegan components are you 

20 using carrageenan as a substitute for? Is it just 

21 gelatin or do you consider things like xanthan gum 

22 or gellan gum, which are derived from bacteria, to 
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1 be non-vegan?

2 MR. HOWARD: Oh, no, no, no, no, I'm 

3 certainly cool with gellan and xanthan. It's 

4 essentially an issue of just replacing gelatin, 

5 certainly, is a huge one for me, and I look at how 

6 that important that is to remove. As a vegan 

7 removing gelatin is a revenue stream for processors 

8 from their byproduct waste, and that's important 

9 to me as a vegan, but as I look at other things, 

10 I'm not concerned with the -- if gellan or xanthan 

11 are or are not vegan. They're vegan to me, so --

12 MEMBER SONNABEND: Okay.

13 MR. HOWARD: -- it's not an issue.

14 CHAIR FAVRE: Okay. Any other 

15 questions for Ryan?

16 MR. HOWARD: Just simply that they don't 

17 make as good or tasty of a product as carrageenan 

18 does, period, in my mind.

19 CHAIR FAVRE: Great. Thank you very 

20 much, Ryan. Next up --

21 MR. HOWARD: You're welcome.

22 CHAIR FAVRE: -- is Myra Weiner, 
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1 followed by Shakeel Rehman.

2 DR. WEINER: Hello, do you hear me?

3 CHAIR FAVRE: Yes, we do, Myra. And I 

4 understand you have a presentation, is that 

5 correct?

6 DR. WEINER: Yes, I do.

7 CHAIR FAVRE: Okay. Folks, just direct 

8 yourself to the screen on the webinar, if you're 

9 online you can see it. Thank you very much. Go 

10 ahead.

11 DR. WEINER: Hello. I'm Dr. Myra Weiner 

12 and I'm here to support the continued listing of 

13 carrageenan under the sunset review. Next slide 

14 please. The safety of carrageenan is 

15 unimpeachable and there is a very large database 

16 of studies to support its safe use in food. The 

17 most recent study conducted is an infant formula 

18 toxicity and toxicokinetic study on pre-weaning 

19 pigs. This was conducted in compliance with GLP 

20 guidelines, with many parameters evaluated, as 

21 shown on this slide.

22 The World Health Organization Joint 
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1 Expert Committee on Food Additives reviewed this 

2 study and determined that carrageenan is safe as 

3 an additive to infant formula and infant formula 

4 for babies with special medical needs. Next slide 

5 please. However, in the docket, we saw letters 

6 indicating that there were flaws in the infant 

7 formula study. I would like to address these 

8 apparent flaws and dispel falsehoods regarding 

9 this study. One, pigs are an excellent proven 

10 animal model for human responses. There is no 

11 substantiation to the epitope theory.

12 Two, as a standard practice, animal 

13 were allowed to nurse for 48 hours to benefit from 

14 maternal colostrum. This is true for every animal 

15 in this study. Three, antibiotics and iron were 

16 given to all animals based on veterinary guidelines 

17 for good animal care. Four, a few incidental 

18 deaths occurred early in the study without regard 

19 to carrageenan dose level, including control 

20 animals. Replacement animals were added to the 

21 study. Five, a slight increase in watery stools 

22 was noticed in some carrageenan treated animals, 
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1 but their growth and health were unaffected.

2 Six, a minor incidence of glucosuria in 

3 a few animals was noted, but did not affect blood 

4 glucose, which was normal. There were no other 

5 hematology findings and no effects on the kidneys. 

6 Seven, a reporting of decreased rectal organ waste 

7 in the male animals at the high dose only was not 

8 considered due to treatment. The reason being, 

9 there was no rectal abnormal histopathology 

10 associated with the rectal organ, the effects were 

11 not seen in female animals, and there were no 

12 changes to any other part of the gastrointestinal 

13 tract. Next slide.

14 Eight, the body weights of the piglets 

15 reflect growth during the study for all dose groups 

16 and were typical for farm feed pigs of the same age. 

17 It is not true that the animals started at a later 

18 age than 48 hours. Nine, thorough evaluation of 

19 all gastrointestinal --

20 (Telephonic interference)

21 DR. WEINER: -- by trained veterinary 

22 pathologists found no treatment related lesions, 
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1 including inflammation. And, ten, the study was 

2 conducted during the pre-weaning period of 

3 piglets, which is 28 days. After that time, 

4 piglets begin eating solid food. So the entire 

5 pre-weaning period was covered. Longer term data 

6 are available in adult animals and different 

7 species. Next slide.

8 CHAIR FAVRE: Dr. Weiner, I'm sorry, 

9 we've hit the deadline for time.

10 DR. WEINER: Okay. Thank you.

11 CHAIR FAVRE: Thank you. Does anybody 

12 have any questions for Dr. Weiner? Yes, Zea, go 

13 ahead.

14 MEMBER SONNABEND: Thank you. Thank 

15 you, Dr. Weiner, for directly addressing some of 

16 the critiques of your study, which is of course 

17 confusing to us when we get so much comment on both 

18 sides of the issue. I'm interested in your 

19 thoughts about the validity of the studies that 

20 involve in vitro techniques and/or water 

21 introduction of carrageenan into the diet. And 

22 the comments that pigs or rats or other animals are 
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1 not sufficiently comparable to humans, compared 

2 to, say, monkeys.

3 DR. WEINER: Yes. I'll be happy to 

4 address those points. Basic to understanding 

5 carrageenan is that it is a very large molecule with 

6 regulatory specifications and typical use would be 

7 greater than 100,000 daltons. It has many 

8 charged sulfate groups, which interact with both 

9 the positive charge groups of proteins and also 

10 cations. And so, a complex of protein in food and 

11 carrageenan forms, which goes through the 

12 gastrointestinal tract as a very large complex and 

13 is excreted unchanged.

14 If carrageenan is given in drinking 

15 water without protein, the charge groups on the 

16 sulfates of carrageenan do not have the opportunity 

17 to be complex in a matrix with protein. Therefore, 

18 those groups can interact with the gut mucosa. And 

19 it is not considered relevant to the food use. So, 

20 drinking water studies are different than the food 

21 use. In vitro, the media in which the cells are 

22 grown contains serum proteins. It's necessary for 
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1 the survival of the cells in vitro and when 

2 carrageenan is added to an in vitro media, it will 

3 complex the protein and, therefore, not be 

4 available to interact directly with the cells or 

5 to be absorbed by the cells.

6 These factors have been published in my 

7 recent paper in 2016, Pitfalls and Parameters to 

8 the Conduct of Food Additive Research, Carrageenan 

9 as a Case Study. And the aspects of the in vitro 

10 system is different from the in vivo system, and 

11 some of the important features to be aware of when 

12 extrapolating from in vitro to in vivo are 

13 discussed by Dr. James McKim in his review article 

14 in 2014 and also shown in some recent SOT abstracts 

15 in 2016.

16 As far as animal species, most animals 

17 do not absorb carrageenan because it's too large, 

18 particularly when it's complexed to protein. 

19 These models have all been verified, many of them 

20 through the OECD standard guidelines, for example 

21 the 90 day study, which is a workhorse for 

22 toxicology, and I've published a 90 days study 
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1 giving carrageenan in diet at the maximum levels 

2 without seeing any effects. So the animal models 

3 are all robust. Pigs in particular are used very 

4 frequently in research because they resemble human 

5 physiology for many organ systems, including the 

6 gastrointestinal tract, the immune system, as well 

7 as the dermal toxicology. You will find many 

8 references to the use of the pig.

9 CHAIR FAVRE: Okay. Thank you, Dr.

10 Weiner. I have one more question. Harold, if we 

11 can make it a brief question, and, Dr. Weiner, if 

12 we can be mindful of the time on your response? 

13 Thank you.

14 DR. WEINER: Yes.

15 MEMBER AUSTIN: Thanks, Tracy. Dr. 

16 Weiner, I asked this question before, but I think 

17 you could probably give us the answer. Could you 

18 briefly explain the differences between poligeenan 

19 and carrageenan?

20 DR. WEINER: Yes. Poligeenan is not a 

21 food additive, it's not a natural product, it is 

22 created artificially by treating carrageenan at 
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1 extreme conditions involving acid hydrolysis at 

2 very low pH, typically around pH 1, and high 

3 temperatures greater than 80 degrees Centigrade 

4 for several hours. The molecular weight of 

5 poligeenan is 10,000 to 20,000 daltons. And at 

6 that low molecular weight, it is nonfunctional in 

7 food. If poligeenan is given directly to animals 

8 at high doses, you will start to see toxicological 

9 effects. But it is a totally different chemical 

10 from carrageenan.

11 Carrageenan is a high molecular weight 

12 additive made from seaweed with an average 

13 molecular weight of 200,000 to 800,000 

14 kilodaltons. It's derived directly from seaweed 

15 under mild conditions involving washing and 

16 cleaning. And because of the high molecular 

17 weight, it does have functionality when added to 

18 food, as I explained earlier, because it complexes 

19 to proteins in the food giving them stability and 

20 functionality in the various products in which it's 

21 used. The poligeenan is not found in commercial 

22 carrageenan.
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1 And carrageenan is not degraded in the 

2 gastrointestinal tract to poligeenan. 

3 Carrageenan is polydispersed and has a broad band 

4 of molecular weight distribution because it's made 

5 from seaweed naturally. But poligeenan as defined 

6 and explained is not found in carrageenan.

7 CHAIR FAVRE: Great.

8 MEMBER AUSTIN: Thank you.

9 CHAIR FAVRE: Thank you very much.

10 DR. WEINER: You're welcome.

11 CHAIR FAVRE: Thank you, Dr. Weiner. We 

12 appreciate you being with us today and thank you 

13 for the presentation. Next up is Shakeel Rehman 

14 with Esteban Macias, if I'm pronouncing that 

15 correctly, on deck.

16 MR. REHMAN: Dr. Weiner talked about the 

17 safety of carrageenan and I am an end user, even 

18 though I am not a toxicological scientist, I am 

19 basically a basic dairy scientist. So we have been 

20 using carrageenan for a long time. And thank you 

21 for providing me this opportunity to talk about 

22 carrageenan. I will emphasize about the use of 
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1 carrageenan. And carrageenan has generally long 

2 history of use in foods, supplemented by credible 

3 science. So that would make continued listing of 

4 carrageenan as an approved nonsynthetic additive 

5 an easy decision.

6 And the credible science supporting 

7 carrageenan's safety argues for continued use in 

8 organic products. If you see, regulatory 

9 authorities in every region of the world, including 

10 United States, Europe, China, Japan, and Brazil 

11 have found carrageenan safe for use in food. It 

12 is in seaweeds which have been harvested and used 

13 as food for century. Carrageenan is a natural 

14 polysaccharide and is not assimilated by the human 

15 body, as Dr. Weiner was just telling just now. 

16 Carrageenan provide a huge unique functional 

17 characters used to gel, thicken, and stabilize food 

18 production.

19 While we are having some online 

20 conversations about the safety of carrageenan, but 

21 there is no conclusive scientific evidence about 

22 any potentially hazards stemming from the use of 
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1 carrageenan as a food additive. Put simply, 

2 carrageenan has undergone total review by World 

3 Health Organization Joint Expert Committee on Food 

4 Additives. The JECFA review covered both 

5 supporting and opposing science and found 

6 carrageenan to be not of concern in an infant 

7 formula. If carrageenan is considered safe even 

8 for the most sensitive members of our population, 

9 then there should not be any doubt that it is safe 

10 for other consumers.

11 Now, as an end user, why we should use 

12 it. Carrageenan should continue to be on the 

13 approved food ingredient list. This is based on 

14 necessity, scientific evidence, and 

15 sustainability of the ingredient. The removal of 

16 carrageenan from the list of approved ingredients 

17 for organic foods would possibly lead consumers to 

18 question the validity of otherwise a very safe food 

19 ingredient. Removal should be based on scientific 

20 basis rather than myths and rumors.

21 And carrageenan is a hydrocolloid that 

22 at very low levels provided necessary mouth feel, 
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1 stability, and sustainability. We use 

2 carrageenan in our dairy beverages and our 

3 experience is that carrageenan works the best among 

4 hydrocolloids. Carrageenan is especially 

5 important in the suspension of cocoa particles and 

6 product stability, long shelf life chocolate milk 

7 beverages.

8 To replace functionality of 

9 carrageenan, it would take combination of two or 

10 three other hydrocolloids and at higher percentage 

11 levels. The ability to limit the number of 

12 ingredients on the label not only allows for 

13 simpler processing, but it keeps sourcing and 

14 production costs at minimum, ensuring affordable 

15 nutritional options for a greater number of people 

16 around the world. Replacing carrageenan with 

17 other hydrocolloids would be very expensive.

18 While carrageenan performs unique and 

19 essential functionality in various applications, 

20 it is the sourcing and processing of the ingredient 

21 that makes it fundamental to organic milk 

22 beverages. Carrageenan is readily available from 
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1 sustainable sources. Further, carrageenan 

2 replaces animal parts in formulations, allowing 

3 more organic other than milk beverages to satisfy 

4 vegan, Kosher, and Halal requirements. 

5 Carrageenan has been used as a sustainable food 

6 stabilizer by cultures around the world for 

7 centuries. Today it is sustainably harvested in 

8 parts of Africa and Asia by nearly 30,000 to 60,000 

9 members.

10 In summary, I support the continued 

11 approval of carrageenan use in organic foods by 

12 NOSB. It is indispensable ingredient in dairy 

13 beverage formulation as it is cost effective and 

14 enables functionality that's not provided by other 

15 stabilizing products that are suitable for and 

16 available to wide range of people. Thank you very 

17 much.

18 CHAIR FAVRE: Great. Thank you, 

19 Shakeel. Any questions for Shakeel? Okay, I 

20 don't see any. Thank you very much.

21 MR. REHMAN: Thank you.

22 CHAIR FAVRE: Next up is Esteban Macias, 
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1 followed by William Matakas on deck. Esteban, are 

2 you with us?

3 MR. MACIAS: Yes, good afternoon. Can 

4 you hear me well?

5 CHAIR FAVRE: Yes, we can. Please go 

6 ahead.

7 MR. MACIAS: Perfect. Thank you very 

8 much. And good afternoon to everyone. I am 

9 calling you from all the way South Central Mexico. 

10 I'd like to introduce myself. I'm Esteban Macias, 

11 I'm the head of the Department of Crop Protection 

12 for the GRUPO U, it's a company that is dedicated 

13 for production of vegetables, that are mainly 

14 exported to the United States, Canada, and also 

15 being consumed here in Central Mexico. Can I have 

16 next slide please? Okay. Thank you.

17 So that's me, actually, holding a nice 

18 organic lettuce. We grow several acres of both 

19 conventional and organic crops. At this point, we 

20 started growing organics in 2004 and we started 

21 with candidates. To this point, 12 years later, 

22 we are doing 500 acres of organic growing, 
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1 including about 49, 50 acres of greenhouse. My 

2 presentation today is regarding some confusion I 

3 think there may be regarding the use of soiless and 

4 containerized techniques for organic production in 

5 greenhouses. Next slide please. Okay.

6 So, we started with our greenhouse 

7 operation in 2005 and I can tell you we started all 

8 the way from scratch. We didn't want to be just 

9 another tomato grower, since we started into 

10 organic production and we started into greenhouse 

11 production, then we said, well, why not become 

12 greenhouse organic growers. Next slide please. 

13 So, you will be able to -- we asked, well, why 

14 organic? And that's because consumers were 

15 demanding pesticide-free fresh produce. And 

16 organic certification does communicate that 

17 condition to the consumer.

18 We also wanted to challenge our 

19 conventional practices. Everything we are doing 

20 organic, it's immediately transferred to the 

21 conventional, so our conventional is what I call 

22 a dirational system, which is actually using a lot 
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1 of organic techniques. Of course, we have our pure 

2 organic production. Next slide please. So this 

3 is how it looks on the beginning. This is the box, 

4 this in the back, that is filled with coconut core, 

5 a mixture of compost, and nutrients that are 

6 organically allowed, fish meal, chicken manure. 

7 We also look at this with about 30 different strains 

8 of beneficial bacteria and fungi. So we actually 

9 turn this coconut core into living soil, maybe it 

10 was a living soil that we started growing on it. 

11 Next slide please.

12 So, we eventually learned a lot about 

13 what we were doing and we learned that disease 

14 management was a must. It's very hard to handle 

15 diseases when you're actually in the soil. In the 

16 next slide, we will see some plants that actually 

17 were killed by disease. We also are dealing with 

18 the conditions of semi-desert like area. We have 

19 very little water, so we are able to reclaim all 

20 the water, but if -- actually we have to do a little 

21 bit of over irrigation to wash down salts and we 

22 also saw the efficiency of nutrient use. Next 
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1 slide please.

2 So that's the way our organic solution 

3 looks right now. And you can see the bags and the 

4 channels we use for reclaiming that water. Next 

5 slide please. And it is challenging, so by working 

6 this way, we've been able to be very efficient in 

7 the nutrition of the plants, otherwise will be a 

8 lot of waste into the underground because it's 

9 littered by water. Next slide please. And this 

10 is a better sample of why we like to do it on 

11 containers. If you get a disease and you have in 

12 containers, you are able to contain that disease. 

13 If you are on soil, that will spread all over and 

14 lose the installation. So that's why we are still 

15 working on that. Next slide please.

16 So that's a recent picture, so if we 

17 suspect a diseased plant, we just pull it out and 

18 sanitize the tub with some approved material and 

19 then move on and people are working with the other 

20 plants healthy. Next slide please. Next slide 

21 please. That's the way it look on the outside. We 

22 are reclaiming every drop of water that is falling 
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1 on top of the greenhouse and also the water that 

2 is coming from the greenhouse is being captured and 

3 used for irrigation. Next slide please.

4 So, we are not actually working on that 

5 system, this is a very leading invested system, but 

6 it is all the time depending on bioactivity in order 

7 to feed the plant. Next slide please. So you can 

8 see, that's our leading site. You can see the 

9 core, you can see the gypsum we applied there, you 

10 can see all that green material there, it is 

11 growing, you can see some chicken manure on front 

12 there. So that's a burden on the system.

13 CHAIR FAVRE: Excuse me, Esteban. I'm 

14 sorry, I didn't hear the signal and I bet you 

15 probably didn't either. So, we're going to have 

16 to cut you off there, I apologize.

17 MR. MACIAS: All right. No problem. 

18 So that was my comment. Thank you very much for 

19 listening and for giving me the opportunity to show 

20 you --

21 CHAIR FAVRE: Great.

22 MR. MACIAS: -- what we are doing.
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1 CHAIR FAVRE: Great. Thank you. 

2 Anybody have any questions for Esteban? Okay. 

3 Thank you very much for coming and --

4 MR. MACIAS: Thank you all.

5 CHAIR FAVRE: -- thank you for the 

6 presentation. Next up --

7 MR. MACIAS: Thank you.

8 CHAIR FAVRE: -- is William Matakas and 

9 then we have Megan Parker on deck. William, are 

10 you with us?

11 MR. MATAKAS: Yes. Yes, I'm here. Can 

12 you hear me?

13 CHAIR FAVRE: Yes, we can. Please go 

14 ahead.

15 MR. MATAKAS: Great. So, yes, thank you 

16 very much for allowing me this time. And I am 

17 William Matakas. I am the manager of marketing and 

18 technology at FMC in our health and nutrition 

19 business. Formerly, I was also the Marinalg 

20 president for the carrageenan industry. So, I'd 

21 like to talk about essentiality today for 

22 carrageenan. Next slide please. And the first 
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1 thing about carrageenan is that it's used at a very 

2 low level compared to many other things that could 

3 be used in foods.

4 Secondly, it has many suppliers, it 

5 provides a very dynamic market, a lot of 

6 opportunities to buy the products. And with the 

7 large number of suppliers, really minimizes the 

8 chances of shortage except in real extreme cases 

9 that happened for odd weather conditions, but it's 

10 very rare that there are shortages. Next slide 

11 please. There is a long history of manufacturing, 

12 so it's a well known process. And there are no real 

13 patents on the carrageenan process so that 

14 manufacturers are free to come and go in the 

15 industry and continue to provide the product to the 

16 users.

17 The other thing that carrageenan does 

18 that is unique in that it has a very broad 

19 functionality that no other single additive could 

20 provide. It is one of the unique hydrocolloids 

21 that can provide a very broad range of viscosities 

22 for products, textures, stability, all derived 
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1 with one product on the label in a time when you 

2 want to have fewer products on our labels. Next 

3 slide please.

4 Carrageenan is one of the few 

5 hydrocolloids that is derived from plants and its 

6 production and raw materials conserve resources in 

7 food production, it doesn't use fresh water, it 

8 doesn't use arable land. Seaweed is produced by 

9 small holder farms across the world in areas and 

10 it is a pathway out of poverty for them. It is not 

11 a genetically modified organism and farmers may 

12 gather the seed stock from nature or save stock as 

13 they produce product for each growing cycle. Next 

14 slide please.

15 When we're looking for a product where 

16 fewer is better on the label, having something very 

17 flexible to respond to changes in what people want 

18 or changes in texture, when having something 

19 sustainable is better, when wanting something in 

20 our food at lower use levels is better, when looking 

21 at the provenance of our food really matters, and 

22 when safety matters, we really believe that 
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1 carrageenan is essential for products for 

2 producers. And that's my last slide. Any 

3 questions?

4 CHAIR FAVRE: Okay, great. Thank you 

5 very much. Any questions for Mr. Matakas?

6 MS. TUCKER: Looks like Tom does, Tom 

7 Chapman.

8 CHAIR FAVRE: Yes. Thank you, Tom. Go 

9 ahead.

10 MEMBER CHAPMAN: I have a couple 

11 questions. I hope they're quick, if they're not 

12 quick, I'll just limit them. So despite being 

13 classified as a non-agricultural substance, from 

14 information in our TR it does appear that it's 

15 possible to produce carrageenan organically, if 

16 the seaweed itself was certified organic. Has FMC 

17 explored producing carrageenan organically at all?

18 MR. MATAKAS: The first step was the 

19 seaweed being classified organic and we've been 

20 waiting to have discussions around organic 

21 aquiculture and those rules to be finalized.

22 MEMBER CHAPMAN: Okay. There are 
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1 currently some organic seaweed products on the 

2 marketplace, I just want to point that out to you. 

3 So, second question, and that's, what cases would 

4 carrageenan not appear on a food label of a product? 

5 And I'm looking at food, alcohol, and personal 

6 care.

7 MR. MATAKAS: It should be on all labels. 

8 It's an ingredient.

9 MEMBER CHAPMAN: If it's used as a 

10 clarifier for your production, they would appear 

11 on the label?

12 MR. MATAKAS: You mean if it were a 

13 processing aid, where it doesn't go into the 

14 product, maybe? I mean, I guess, I'm confused --

15 MEMBER CHAPMAN: Okay. Classic 

16 applications in food, alcohol, and personal care.

17 MR. MATAKAS: I mean, if it is in the 

18 final product, then I guess it would have to be on 

19 the label by law. So, I don't know why it wouldn't 

20 be on the label, would be my question. We process 

21 it as an ingredient, it's an approved additive, so 

22 under those rules, it would be on the label, as far 
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1 as we know.

2 MEMBER CHAPMAN: Thank you.

3 MR. MATAKAS: Okay.

4 CHAIR FAVRE: Okay. Thank you, 

5 William, very much for your --

6 MR. MATAKAS: Okay.

7 CHAIR FAVRE: -- presentation today. 

8 Next up on our list is Megan Parker, but we haven't 

9 been able to locate her. Megan, if you're out 

10 there, we're going to move you to the end of the 

11 list and we'll try to get to you at that time.

12 MS. TUCKER: But please chat us with a 

13 phone number. If you are online and you can hear 

14 us, we need to know who to unmute, so send us your 

15 area code and phone number from which you are 

16 calling so we know who to unmute.

17 CHAIR FAVRE: Yes, thank you. Okay. 

18 So that moves us to Zen Honeycutt, with Colehour 

19 Bondera on deck. Jenny, have we been able to 

20 unmute Zen?

21 MS. TUCKER: We think so. Zen, are you 

22 there?
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1 CHAIR FAVRE: Zen, are you there? We 

2 can't hear you.

3 MS. TUCKER: Zen, you just muted 

4 yourself. I'm going to unmute you, try again. 

5 No, don't touch the phone, just start -- just a sec. 

6 Okay. Zen, just -- okay. Zen, just start 

7 talking, don't touch the phone, just start talking.

8 CHAIR FAVRE: Okay. Zen, are you there?

9 MS. TUCKER: Zen, if you're there, try 

10 talking.

11 MS. HONEYCUTT: Can you hear me now?

12 MS. TUCKER: Yes.

13 CHAIR FAVRE: Yes, we can.

14 MS. HONEYCUTT: Okay, great.

15 CHAIR FAVRE: Go ahead.

16 MS. HONEYCUTT: Thank you. Sorry about 

17 that. Okay. So I want to say thank you to the 

18 distinguished National Organic Standards Board of 

19 Directors, thank you for the opportunity to speak. 

20 Moms Across America is speaking out for organic 

21 standards because food is the number one factor in 

22 health. Do you have my presentation in front of 
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1 you?

2 CHAIR FAVRE: Yes. Just let me note for 

3 the audience that we do have a presentation for Zen 

4 and it's now showing up on the webinar screen. Go 

5 ahead.

6 MS. HONEYCUTT: Okay, great. Food is 

7 the number one factor in health and many of our 

8 children require organic food to have good health 

9 and, in many cases, to live. The contamination of 

10 organic by toxic chemicals violates our right to 

11 health and threatens our children's lives. So, we 

12 must be able to trust that organic is truly organic. 

13 We want carrageenan, an unnecessary chemical, 

14 removed from the allowable list and for the NOSB 

15 to take steps in a coalition to product organic from 

16 glyphosate and other toxic chemicals. We have --

17 slide.

18 We have Jennifer Lawrence in here who 

19 says that, I had an awesome team of doctors at a 

20 children's hospital that could not figure out what 

21 was wrong with my daughter, who was getting sick 

22 after nearly every meal. The moms posting on 
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1 Facebook that their children got better when they 

2 got off GMOs saved my daughter's life. That day, 

3 I went out and bought organic food and she stopped 

4 throwing up.

5 So, we see that our children get better 

6 when they avoid GMOs and toxic chemicals and eat 

7 organic, however, some of our children are still 

8 experiencing inflammation and rashes, even when 

9 they eat organic. And this inflammation can lead 

10 to cancer. And we see this as -- slide -- our 

11 families are the sickest in the developed world and 

12 our babies and even our men are dying at much higher 

13 rates than other countries. And we believe that 

14 the widespread use and contamination of glyphosate 

15 is a major contributing factor. Slide.

16 Widespread use of glyphosate on 

17 streets, backyards, trees, and food has made this 

18 chemical ubiquitous. Slide. Ib Pedersen, farmer 

19 from Denmark, says that roundup and glyphosate is 

20 contaminating our food supply through the 

21 irrigation system, through the rain, through the 

22 animal products such as manure, and through 
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1 chemical drift. Now, if glyphosate is found in 

2 organic farms, we request that the owner to report 

3 occurrences in a private manner and that the NOSB 

4 or governmental agencies take on the 

5 responsibility of holding neighboring farms who 

6 are contaminating for cleanup. Holding them 

7 responsible.

8 We request that the NOSB take on 

9 leadership to instigate legal action with other 

10 environmental groups as necessary so that organic 

11 farmers are not penalized or suffer losses as these 

12 contaminations are not their intention and they are 

13 victims of a toxic system. We are extremely 

14 concerned about the widespread contamination of 

15 glyphosate. Slide. The glyphosate has 

16 contaminated our tap water, our urine, and even our 

17 breast milk. Slide. It's also contaminated our 

18 cereal, bread, honey, cotton products, beer, and 

19 wine. Slide. Including PediaSure feeding tube 

20 liquid, which was given to children with cancer.

21 We want it on the record that consumers

22 do not want any tolerance level to be set for 
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1 glyphosate or any other toxic chemicals such as 

2 Atrazine, 2,4-D, Paraquat and other toxic 

3 chemicals in organic food at all. Slide. We see 

4 collateral damage of glyphosate, which is harming 

5 millions and millions, hundreds of millions of 

6 Americans, and I can give you this data later. So, 

7 slide.

8 We request the actions to take are that 

9 the NOSB is vocal and takes action to revoke the 

10 license of glyphosate and toxic chemicals that are 

11 used on chemical farms, including non-organic. We 

12 request that NOSB policy to disallow the 

13 contamination of organic fertilizer by toxic 

14 chemicals and GMOs and that manure from animals fed 

15 GMO feed is not allowed in organic -- I'm sorry, 

16 I didn't say slide -- in organic fertilizer. And 

17 then, slide.

18 We understand that some of these 

19 actions are not in the scope of what NOSB addresses, 

20 however, we assert that in these times, we must all 

21 go beyond what we are expected to do. We ask that 

22 you take these steps to address the contamination 
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1 of glyphosate, disallow carrageenan and toxins, 

2 and protect organic standards, thereby protecting 

3 the health of current and future generations. We 

4 want to say thank you so much for your time and 

5 attention.

6 CHAIR FAVRE: Great. Thank you very 

7 much, Zen. Anybody have questions for Zen? Okay, 

8 I don't see any. Thank you very much for your 

9 presentation, Zen.

10 MS. HONEYCUTT: Thank you.

11 CHAIR FAVRE: Next up is Colehour 

12 Bondera and then following Colehour will be 

13 Katherine DiMatteo. Colehour, are you with us?

14 MR. BONDERA: Yes, can you hear me?

15 CHAIR FAVRE: Yes, we can. Nice to hear 

16 your voice. Please go ahead.

17 MR. BONDERA: Great, thank you. Okay. 

18 Aloha to Chair Tracy and to all NOSB members. Your 

19 time and consideration are really appreciated. 

20 Thank you really for your dedication to maintaining 

21 organic integrity. And my name, like I was 

22 introduced, is Colehour Bondera, I'm a small scale 
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1 organic farmer. I'm a former NOSB member, my term 

2 ended January of 2016. The processes of your 

3 consideration and decision making are well 

4 understood through those experiences. Following 

5 the guidance of NOSB Chair Emeritus Barry Flamm, 

6 for two years it was my pleasure to work with and 

7 serve the NOSB as the Policy Development 

8 Subcommittee Chair.

9 Integrity of the process to maintain 

10 organic standards in a healthy and transparent 

11 manner is the common thread that holds us all 

12 together. We must start with the basics of a 

13 healthy process and internal policies and 

14 procedures of decision making. So those are rules 

15 that we can all follow together and not simply 

16 change as individuals prefer. Remember that NOSB 

17 is a public advisory board, and that means you all 

18 are listening to input from people such as myself, 

19 the public, to make well informed and balanced 

20 decisions.

21 That said, as stated in my written 

22 testimony, it is with severe concern that the NOSB 
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1 is now considering voting through the changes as 

2 presented to the PPM without full consideration and 

3 review. If a subject merits scheduled 

4 consideration and review on a Subcommittee call 

5 and/or inclusion on the spreadsheet of items as was 

6 prepared, then like in all of the NOSB 

7 Subcommittees, it is with due diligence that said 

8 item, after consideration by the Subcommittee, is 

9 then seriously considered by the full NOSB. The 

10 Subcommittee is simply making a suggestion to the 

11 Board and each material determination is due its 

12 place for review and inclusion, which in the past 

13 has meant a vote, which is how the PDS has behaved 

14 in terms of items to be added or modified within 

15 the policy and procedure manual.

16 As the former chair of the PDS, it was 

17 quite disturbing when the NOP put forth that they 

18 should somehow be the ones to review and change our 

19 guiding internal document, policy and procedure 

20 manual, which some call the NOSB Bible, not at our 

21 request, but rather because it was not seen as being 

22 maintained in a needed manner. For your 
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1 information, the first round of such concessions 

2 ended up with a compromise, that there should be 

3 two categories of changes and implementation 

4 thereof. First would be administrative changes 

5 and second would be to identify significant areas 

6 of modification or addition and have those put 

7 forth as sub-groups or individually so they could 

8 be seriously and completely reviewed and 

9 considered.

10 Then, the NOP decided that the PDS would 

11 cease to function as a standing Subcommittee and 

12 instead was relegated as ad hoc. When that was 

13 again changed by the NOP, and this was over several 

14 years, the previous agreement was put aside and new 

15 NOSB members took on working with the NOP on how 

16 to update the PPM. The agreement to separate the 

17 administrative updates from content changes was 

18 dismissed without further discussion, and the NOP 

19 decided to rewrite our Bible to meet their 

20 priorities and interpretation.

21 Again, the NOSB should be proposing 

22 changes to the PPM, not reviewing what changes the 
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1 NOP staff made and then justifying those changes. 

2 NOSB is an advisory board, not a reaction to NOP 

3 Subcommittee. Some significant areas, and by no 

4 means all, from my perspective include the 

5 rewritten NOSB/NOP collaboration section, the 

6 required NOP hiring of a staff director, clarity 

7 of NOSB rules and changes to the PPM and the 

8 establishment of internal procedures, changes to 

9 minority report section, the sunset review 

10 process, and the manner in which presence at a 

11 meeting is defined and justified.

12 We are now at a place where bundling of 

13 changes and automatic acceptance of new choices is 

14 simply carried forth as if the only role of NOSB 

15 is rubber stamping what is ordered and not what is 

16 healthiest for all. Many items must be completely 

17 reviewed and each must be voted upon separately, 

18 or at minimum, discussed within the NOSB as a whole. 

19 Significant detail and analysis concluded for many 

20 items, again, not necessarily all, and the written 

21 testimony of groups that -- I've reviewed some of 

22 it, from Beyond Pesticides and Cornucopia, there's 
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1 others as well, representing many thousands of 

2 members, which merit both consideration -- I have 

3 one more sentence.

4 Please send or take this revised PPM 

5 back to the Policy Development Subcommittee for 

6 further efforts to support the document, which 

7 deserves a vote and likely does not include all of 

8 the other pieces that must be considered 

9 independently. And it's set up so that those 

10 pieces at minimum could be voted upon prior to the 

11 whole being approved. Those are my comments. 

12 Thank you for listening.

13 CHAIR FAVRE: Great. Thank you, 

14 Colehour. Anybody have any questions for 

15 Colehour?

16 MEMBER CHAPMAN: This is Tom, I do.

17 CHAIR FAVRE: Okay. Go ahead, Tom.

18 MEMBER CHAPMAN: Aloha, Colehour, great 

19 to hear --

20 MR. BONDERA: Aloha.

21 MEMBER CHAPMAN: -- your voice again and 

22 --
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1 MR. BONDERA: Good to be here.

2 MEMBER CHAPMAN: -- receive your 

3 comments. I'm a little surprised you chose the 

4 webinar format because, as you're probably aware, 

5 the current outdated PPM states full Board 

6 conference calls or full Board summits via 

7 electronic bulletin board are not permitted. But, 

8 all the same, I am happy to get your feedback and 

9 wanted to address the section about the NOP 

10 involvement and PPM approval that you just raised. 

11 Are you aware of sections of OFPA that specifically 

12 talk about the agency's ability to set or approve 

13 procedures?

14 MR. BONDERA: I'm not going to be able 

15 to cite or quote something, but, yes, generally 

16 speaking.

17 MEMBER CHAPMAN: Okay.

18 MR. BONDERA: You're saying, I'm sorry, 

19 am I familiar with or am I aware that it says that 

20 NOP has to basically, it has to be approved by?

21 MEMBER CHAPMAN: I'm asking you what 

22 your interpretation of what it says in OFPA, from 
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1 your extensive experience in this area.

2 MR. BONDERA: Yes. Unfortunately, I 

3 cannot right off the cuff, sorry. But I do 

4 acknowledge that what we put forth does have to be 

5 reviewed and approved, but that's different than, 

6 like I said, it's different than us reacting to 

7 something else that NOSB is being told. It's two 

8 different paths, maybe to the same end, but it's 

9 a different strategy.

10 MEMBER CHAPMAN: Excellent. If I'm 

11 understanding your comments right, you do believe 

12 that the NOP needs to approve the PPM?

13 MR. BONDERA: Absolutely.

14 MEMBER CHAPMAN: Great. Thank you, 

15 Colehour.

16 MR. BONDERA: Yes.

17 CHAIR FAVRE: Any other questions for 

18 Colehour? Okay. Thank you, Colehour. We 

19 appreciate you joining us today.

20 MR. BONDERA: Thank you. Aloha.

21 CHAIR FAVRE: Aloha. Next up is 

22 Katherine DiMatteo and then we've got Steve Etka 
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1 on deck. Katherine, are you there?

2 MS. DiMATTEO: I am here. Can you hear 

3 me?

4 CHAIR FAVRE: Yes, we can. Please go 

5 ahead. Thank you.

6 MS. DiMATTEO: All right. Thank you. 

7 As introduced, my name is Katherine DiMatteo. I'm 

8 a partner in a consulting firm, Wolf, DiMatteo + 

9 Associates, who have been providing advice and 

10 service to the organic sector for over 25 years. 

11 Thank you for the opportunity to comment, for 

12 setting up these webinars that allow more 

13 participation in the NOSB process, and for your 

14 dedicated work as volunteers to maintain the 

15 integrity of the organic sector and encourage its 

16 growth and continuous improvement. My comments 

17 today reflect what has been stated in our submitted 

18 comments to the Crop Subcommittee via 

19 regulations.gov.

20 First, EPA List 4 on NPEs. We 

21 appreciate that the Subcommittee has made it clear 

22 that inert ingredients in the category of NPEs will 
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1 not be allowed and that input companies should work 

2 to phase out their use. We ask that the NOSB and 

3 the NOP allow input companies sufficient time to 

4 reformulate effective products without NPEs. The 

5 Subcommittee has suggested a three to four year 

6 time line from the publication of the discussion 

7 document. We ask that the time frame be set at 

8 three years from the publication of the final rule 

9 for inert ingredients on the SCIL, that's the crop 

10 and ingredient list from Safer Choice, not from the 

11 publication of this discussion paper.

12 We encourage the inerts working group 

13 to focus its resources on moving quickly to publish 

14 information on how the NOP compliant inert 

15 ingredients will be identified on the Safer Choice 

16 Ingredients List and how NOP criteria for inert 

17 ingredients will be assessed when a new inert 

18 ingredient is submitted to be included on the Safer 

19 Choice list.

20 Biodegradable mulch film, we urgently 

21 request that currently available biodegradable 

22 mulch films which meet the national list criteria 
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1 and definitions in the NOP regulation be allowed 

2 for use immediately. To accomplish this, the NOP 

3 Policy Memo 15-1 will need to be corrected to match 

4 the actual language of the regulation. Another 

5 growing season will pass without farmers having 

6 access to this type of mulch film because of the 

7 delay in the recommendation from the NOSB 

8 concerning changes to the NOP Policy Memo.

9 Our understanding of the NOSB 

10 discussions and vote to add biodegradable mulch to 

11 the national list was that bio-based content would 

12 be required and the contents would be tested and 

13 reported, but no minimum content would be required. 

14 However, the NOP Policy Memo restricted 

15 biodegradable mulches to only those that are 100 

16 percent bio-based. There are no 100 percent 

17 bio-based biodegradable agricultural mulches 

18 available today, nor are there any expected in the 

19 near future.

20 The original petition for 

21 biodegradable mulch film, the supporting document, 

22 the independent technical review, all indicated 
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1 that some petroleum products are part of the 

2 production process. In fact, many materials on 

3 the national list of allowed synthetics are derived 

4 from petroleum products and the biodegradable 

5 mulch film should not be treated differently.

6 Natural sodium nitrate, according to 

7 the recommendation of the NOSB, the annotation for 

8 the use of sodium nitrate was to sunset in October 

9 of 2012, but there has not been any rulemaking to 

10 this effect. We urge the NOSB to request that a 

11 proposed and final rule that reflects their 

12 decision of 2011 be published prior to October 

13 2017, the sunset date for the sodium nitrate. The 

14 silent allowance of sodium nitrate that exists 

15 right now has caused an unfair situation and 

16 competitive disadvantage for the input companies 

17 and the growers who are honoring the April 2011 

18 recommendation vote of the NOSB to prohibit its 

19 use. Thank you.

20 CHAIR FAVRE: Great. Thank you very 

21 much, Katherine. Zea, I see you had a question?

22 MEMBER SONNABEND: Yes. Hi, Katherine.
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1 MS. DiMATTEO: Hi, Zea.

2 MEMBER SONNABEND: In regards to sodium 

3 nitrate, you're suggesting we pass a new

4 recommendation to supplement the one that we've 

5 already passed?

6 MS. DiMATTEO: Either a new 

7 recommendation, if that's the proper procedure, or 

8 at least a message to the NOP that they should put 

9 out a proposed and final rule based on the 2011 

10 decision.

11 MEMBER SONNABEND: Yes, because it's a 

12 very awkward situation since we weren't even 

13 allowed to consider it in sunset, even though it 

14 still is technically on the national list. So, I 

15 do feel like our hands are somewhat tied. But --

16 MS. DiMATTEO: Yes. Well --

17 MEMBER SONNABEND: -- we'll look.

18 MS. DiMATTEO: I can appreciate that, 

19 but, as you may know, the people, farmers, input 

20 supply companies, they're using sodium nitrate 

21 either at way more than 20 percent, which is what's 

22 currently still on the national list, and it's all 
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1 over the place right now. There's no consistency 

2 at all in what's happening.

3 MEMBER SONNABEND: Yes.

4 MS. DiMATTEO: And I guess maybe my 

5 message is more for the NOP than for the NOSB, but 

6 if the NOSB can urge in some way that their 2011 

7 decision be acted upon, it would be very helpful 

8 to our organic community and to our international 

9 equivalency partners.

10 MEMBER SONNABEND: Thank you.

11 CHAIR FAVRE: Great. Thank you, 

12 Katherine. Anybody else have any questions for 

13 Katherine? Okay, I don't see any. Thanks again, 

14 Katherine.

15 MS. DiMATTEO: You're very welcome. 

16 Thank you all.

17 CHAIR FAVRE: Next up is Steve Etka and 

18 followed by Erik Gundersen on deck. Steve, are you 

19 with us?

20 MR. ETKA: I am. Can you hear me?

21 CHAIR FAVRE: Yes, we can. Please go 

22 ahead.
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1 MR. ETKA: Great, thanks. My name is 

2 Steve Etka. I'm policy director for the National 

3 Organic Coalition. Thanks for this opportunity to 

4 testify in advance of the NOSB meeting. I wanted 

5 to take a moment to highlight a few issues. One, 

6 NOC appreciates the Board's work to find a more 

7 workable solution to the imbalance in the sunset 

8 review workload. As you all have heard from us 

9 many times, the sunset review process as laid out 

10 in OFPA is a critical aspect of the integrity of 

11 the organic label and we will continue to insist 

12 on adherence to the letter and spirit of the sunset 

13 process.

14 But there's no question that the 

15 workload has become unmanageable and unbalanced 

16 from a time perspective and we believe that 

17 rebalancing the list will result in higher quality 

18 reviews because you will have the time to give each 

19 material reviewed the necessary attention. But it 

20 will also improve public involvement we think, 

21 because by evening out the number of items for the 

22 public to comment on at any one time during a shared 
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1 comment period, it gives the public more time to 

2 give it the time needed as well.

3 To be more specific, in terms of the 

4 concepts presented on this topic by the Policy 

5 Development Subcommittee, we believe that Option 

6 B is the option most in line with NOC thinking on 

7 this matter, because it groups similar materials 

8 together for review. This fosters a comparison of 

9 different materials used for similar purposes in 

10 a way that allows for better review of the necessity 

11 and essentiality criteria. In addition, in the 

12 case of materials that have uses in more than one 

13 type of operation, it allows for both uses to be 

14 analyzed in one TR, which of course would be more 

15 efficient.

16 The second issue I wanted to mention is 

17 the topic of the review of copper sulfate in rice 

18 production use. Some real concerns about the 

19 impact of the material on certain non-target 

20 aquatic life that actually have beneficial 

21 properties. For example, many of the affected 

22 non-target species feed on algae or prey on tadpole 
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1 shrimp in the rice patties, which are of course the 

2 main reasons for using the material itself. So, 

3 from a systems approach perspective, harming the 

4 species that feed on algae and tadpole shrimp may 

5 be very counterproductive.

6 Having said that, we also recognize 

7 that copper sulfate has been used for centuries in 

8 agriculture and there are no good alternatives 

9 available right now for organic rice farmers. 

10 Which leads me to a common refrain that you've often 

11 heard from NOC in recent years, which is the 

12 importance of USDA research funding to the work 

13 that you all do on the NOSB. And we appreciate that 

14 the Board now regularly communicates with the USDA 

15 about unmet research needs that are critical to the 

16 work that you all do, including the need for more 

17 research into alternatives for copper sulfate.

18 And I believe USDA has heard these 

19 concerns in general because one of the stated 

20 focuses of the Organic Transition Program is to 

21 support research into alternatives for materials 

22 on the national list. And we appreciate that your 
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1 current list includes alternatives to copper 

2 sulfate. So we're asking that the NOSB request a 

3 report on recent research of alternatives to copper 

4 sulfate use in rice production. If there is no 

5 satisfactory research on alternatives to copper 

6 sulfate, we believe a robust research strategy must 

7 be recommended by the NOSB to then appeal that 

8 funding is urgently needed to ensure that research 

9 is carried out.

10 Another issue of environmental concern 

11 to us is the use of cellulose from wood pulp for 

12 use in organic handling. We believe there may be 

13 more environmentally friendly materials, such as 

14 rice hulls, that have the anti-caking and 

15 filtration aid functions currently being provided 

16 by cellulose processed from wood pulp. And we 

17 believe the availability of alternatives to 

18 cellulose from wood pulp, such as rice hulls, 

19 should also be on the NOSB list of unmet research 

20 needs. Thanks for this opportunity to testify. 

21 Right on time.

22 CHAIR FAVRE: Good timing. Another 
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1 reward sent to you via the phone. Thank you, 

2 Steve.

3 MR. ETKA: Okay.

4 CHAIR FAVRE: Anybody have questions for 

5 Steve? I'm not seeing any if there are some. 

6 Okay, it looks like, no. Thank you very much, 

7 Steve. We appreciate it.

8 MR. ETKA: All right. Thank you.

9 CHAIR FAVRE: Next up is Erik Gundersen, 

10 followed by Farley Baricuatro, if I said that 

11 correctly, on deck.

12 MR. GUNDERSEN: Can you hear me?

13 CHAIR FAVRE: Yes, is this Erik?

14 MR. GUNDERSEN: Yes.

15 CHAIR FAVRE: Yes, we can hear you. Go 

16 ahead, Erik. Thank you.

17 MR. GUNDERSEN: Okay. Thanks. My name 

18 is Erik Gundersen. I am a certification 

19 specialist at MOSA. MOSA is an accredited 

20 certification agency located in Viroqua, 

21 Wisconsin. We certify approximately 1,700 

22 organic operations across the United States, 
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1 including approximately 215 handlers. So I'm 

2 going to be commenting today primarily on the 

3 discussion document regarding the annotation 

4 change to vitamins and minerals on 205.605(b) of 

5 the national list.

6 This discussion document outlines two 

7 options that would change the annotation for 

8 vitamins and minerals. We recognize the 

9 challenging nature of this topic and appreciate the 

10 time and thought that has gone into this document. 

11 In MOSA's work on this topic, we have been in 

12 contact with other ACAs and found that there are 

13 differences in the interpretation of this current 

14 annotation. This is partially due to the 

15 incorrect section of the FDA CFR that we are 

16 cross-referencing, and it's also due to unclear 

17 guidance from the NOP over the past decade.

18 As a relatively new employee of an ACA, 

19 I can't tell you how strongly I feel that the NOP 

20 needs to be striving for clarity in regulations so

21 that ACAs can work towards consistency of 

22 interpretation. And while we, both MOSA and the 
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1 ACA community, are always working diligently 

2 towards that goal, this clarification from the NOSB 

3 and NOP will aid in meeting that goal. In 

4 developing our opinion on this subject, MOSA looked 

5 first to the needs of our clients and staff, as well 

6 as the opinions and needs of the organic consumer.

7 We feel that organic food processors 

8 adding synthetic vitamins and minerals should not 

9 be relegated to the made with organic category, as 

10 is outline in the first option from the discussion 

11 document. Requiring all of our clients currently 

12 using these ingredients to change their label 

13 claims would be a tricky and cumbersome process to 

14 navigate. The proposed changes outline in Option 

15 1 has the potential to cause much consumer 

16 confusion and to cost processors significant 

17 money.

18 Therefore, we here at MOSA are in favor 

19 of an annotation where synthetic vitamins and 

20 minerals are allowed in organic and made with

21 organic products. This new annotation would cite 

22 the correct sections of the FDA CFR 101.9, as well 
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1 as the two sections referencing fortification of 

2 infant formula, and it would also cite the FDA 

3 standards of identity, which we believe would 

4 ensure vitamins and minerals would be used when 

5 they are mandated by law. This annotation would 

6 provide the strongest possible footing to ACAs when 

7 reviewing products containing these ingredients, 

8 which we believe would prevent their misuse.

9 And as a tag-on to this topic, MOSA 

10 would strongly request further time be spent on 

11 accessory nutrients, such as Omega-3 fatty acid, 

12 DHA, and ARA. As the organic industry and the 

13 demand for highly nutritious food grows, we are 

14 seeing more and more organic processors requesting 

15 the use of these ingredients. MOSA is aware that 

16 there is an interim rule regarding the use of these 

17 ingredients, but similar to the current annotation 

18 for vitamins and minerals, having these 

19 ingredients being allowed under an interim rule has 

20 opened the door for a number of interpretations 

21 and, therefore, inconsistency in the review of 

22 these ingredients industry-wide.
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1 Again, ACAs must have thoughtful, 

2 clear, established regulations from which to 

3 review these ingredients. We request that the 

4 NOSB take up the review of these ingredients in 

5 order to determine their acceptability in organic 

6 and made with organic products. So, in closing, 

7 I just would like to say that the public comment 

8 process is a critical element of keeping the 

9 organic label strong and we here at MOSA greatly 

10 appreciate this process being opened up to include 

11 not only the in-person comments, but this webinar 

12 as well. And just wanted to say, thanks for your 

13 work on this and all the other topics being worked 

14 on this cycle.

15 CHAIR FAVRE: Another perfect timing.

16 MS. TUCKER: Perfect timing.

17 CHAIR FAVRE: Great. Thank you very 

18 much, Erik. This is a tough subject, we appreciate 

19 you tackling it and giving the ACA's perspective. 

20 Anybody have any questions for Erik? Okay, thank 

21 you very much, Erik.

22 MR. GUNDERSEN: Yes. Thank you.
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1 CHAIR FAVRE: Next up is Farley 

2 Baricuatro, if I'm saying that correctly, and then 

3 we've got Debra Clement on deck. Farley, are you 

4 with us?

5 MS. TUCKER: He is on the line and we 

6 unmuted him.

7 CHAIR FAVRE: Okay. Farley, if you're 

8 speaking, we can't hear you.

9 MS. TUCKER: Farley, we have you on your 

10 headset. If you are dialing from a phone instead 

11 of your headset and you can't hear us, go ahead and 

12 chat your phone number in and we can find you on 

13 the phone list. We've unmuted you on your headset.

14 CHAIR FAVRE: Jenny, I think he had sent 

15 in a phone number earlier in a chat, since he was 

16 calling from an international number, I think, 

17 wasn't he?

18 MS. TUCKER: Okay. Hold on a sec, let 

19 me see if I can find that. Which area code is it? 

20 6391?

21 CHAIR FAVRE: Okay. Bear with us folks. 

22 I feel like I should have a standup routine to fill 
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1 these dead air spots. Sorry, guys, I'll prepare 

2 better next time.

3 MS. TUCKER: Yes. Hold on one second. 

4 There we go, okay, it was 63917. I don't have any 

5 number that looks remotely like that. Just one 

6 second. Maybe it's the 917? No, I don't have any 

7 area code that looks like that number.

8 CHAIR FAVRE: Okay. Farley, in the 

9 interest of moving things along, if you could go 

10 ahead and send in a chat with a phone number that 

11 you are going to be using again, that would be 

12 great, but we're going to move on to the next 

13 commenter and we'll come back to you at the end. 

14 Next up is Debra Clement. And I see Debra will be 

15 -- oh, I see Farley. Farley, we'll go ahead and 

16 put you up and we'll go ahead and let Debra speak. 

17 Jenny, if you can go ahead and unmute Debra. She 

18 just sent in a phone number.

19 MS. TUCKER: Okay. Hold on. We're not 

20 seeing an 0458 in the list.

21 CHAIR FAVRE: Okay. It looks like we're 

22 having dueling phone number problems. Can we go 
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1 back to Farley then while you and Debra straighten 

2 things out?

3 MEMBER CHAPMAN: Debra's name is listed, 

4 do you want to try Debra.

5 MS. TUCKER: I just saw her. There she 

6 is.

7 CHAIR FAVRE: There she is. Okay. 

8 Debra, you are unmuted, you should be able to speak. 

9 Can we --

10 MS. CLEMENT: Hello?

11 CHAIR FAVRE: Are you there, Debra?

12 MS. CLEMENT: Yes, can you hear me?

13 CHAIR FAVRE: Yes, we can. Please go 

14 ahead.

15 MS. CLEMENT: Excellent. Well, thank 

16 you very much for the opportunity to address you 

17 all today. I would like to highlight the 

18 importance of sodium lactate in our organic 

19 products and the reason that we believe it's a 

20 valuable and suitable ingredient for inclusion on 

21 the national list. So, today, I'll look at sodium 

22 lactate, although the concepts can also be applied 
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1 to potassium lactate. I believe that the summary 

2 presented in the discussion document --

3 (Telephonic interference)

4 MS. CLEMENT: -- highlights that sodium 

5 lactate is both an important and a safe ingredient 

6 to use in organic food processing. It's 

7 versatility and wide functionality means that it 

8 has an important application to many foods.

9 So why is sodium lactate such an 

10 important ingredient for organic processing? 

11 Well, we all love freshly picked organic produce, 

12 although the reality of consumer demand for fresher 

13 more convenient products in no way has given rise 

14 to the specific segment of the food industry 

15 dedicated to safe, high quality food with great 

16 flavor, color, and nutrition. So, herbs and 

17 spices, this is incredibly important as the 

18 volatile flavors and aromas are extremely delicate 

19 and unstable and, therefore, traditional food 

20 processing techniques, such as heat treatment and 

21 acid preservation, destroy the colors and flavors 

22 and also affect nutrition.
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1 So this is really not acceptable when 

2 herbs' entire purpose for existing is imparting 

3 color and flavor to meals, as well as numerous 

4 health benefits. So, for us at Gourmet Gardens, 

5 searching out ways to process organic foods which 

6 deliver on consumer expectation is what we're all 

7 about. And sodium lactate is a key ingredient in 

8 producing the highest quality herbs and spices, 

9 which deliver on flavor and nutrition and are also 

10 safe to use. Its amazing versatility and wide 

11 functionality have allowed us eliminate all 

12 artificial preservatives from our products.

13 So, let me walk you through how this 

14 works. Sodium lactate is a combination of lactic 

15 acid and sodium hydroxide. This is important as 

16 it contains the inherent antimicrobial 

17 functionality of lactic acid, plus it imparts 

18 additional antimicrobial functionality through 

19 reduced water activity, plus it does all this at 

20 an ideal pH range, without destroying the 

21 chlorophyll. So, I want to thank you for changing 

22 the annotation to include pH regulator.
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1 Reducing water activity in 

2 preservatives and products, we discovered natural 

3 preservation methods like salt and also found that 

4 introducing many hurdles alongside each other 

5 could achieve much greater safety than one hurdle 

6 alone. Also, using many hurdles can reduce the 

7 damage of harsh heat treatment. For example, 

8 reducing water activity can reduce the cook time 

9 and produce a far higher quality and more natural 

10 product.

11 Add to that the natural antimicrobial 

12 functionality, the right pH, and suddenly you have 

13 a product that's actually retaining the natural 

14 attributes of the raw product, but it's still safe, 

15 hence eliminating preservatives without having to 

16 cook all the goodness out of it. And these 

17 products will still remain safe once opened. So, 

18 sodium lactate can eliminate the need for 

19 artificial preservatives and it has proven 

20 effectiveness, unlike some other emerging 

21 antimicrobials mentioned in the technical review, 

22 which despite some promising research results, a 
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1 lot of them had very limited commercial merit.

2 So, the second part of the equation is 

3 that sodium lactate is not just a different type 

4 of lactic acid. Lactic acid is acidic, so it 

5 destroys the green color of chlorophyll and it's 

6 not good for our health to consume highly acidic 

7 food. To make the case, sodium lactate comes to 

8 the rescue, providing antimicrobial capability, 

9 water activity control, and maintaining the pH in 

10 the correct range for the optimum product 

11 experience and consumer health.

12 So this is why there are currently no 

13 substitutes already on the national list and we 

14 have tried several. Food is extremely complex and 

15 there are many different types of degradation we 

16 need to control, microbial, chemical, enzymatic, 

17 physical. So this is why we believe that sodium 

18 lactate has a place on the national list, to allow 

19 safe, convenient organic food options. Thank you 

20 very much.

21 CHAIR FAVRE: Good timing, Debra. 

22 Thank you very much. Anybody have questions for 
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1 Debra? Harold?

2 MEMBER AUSTIN: Yes. Hi, Debra, thank 

3 you. Kind of a two part question. One, and I 

4 think you've partially answered it, but what would 

5 be the significant impact on your business and your 

6 growers that supply you the goods if sodium and 

7 potassium lactate were removed from the national 

8 -- well, were not added to the national list and 

9 therefore you were not able to use it? And second 

10 part of this, when did you guys start to use the 

11 sodium lactate as part of your process? Before or 

12 after the NOP's prior decision that listing these 

13 was not necessary? Do you know?

14 MS. CLEMENT: Okay. So firstly, there 

15 would be significant impact on our product, on our 

16 business, because we use sodium lactate in a lot 

17 of different products. Every product is different 

18 and it's formulated different, because each herb 

19 and spice is different, but sodium lactate is very 

20 important in most of our products. And we've used 

21 sodium lactate before 2004 and we've used sodium 

22 lactate in our organic products since we first 
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1 launched organic products.

2 MEMBER AUSTIN: Okay. Thank you.

3 MS. CLEMENT: Thanks.

4 CHAIR FAVRE: Any other questions for 

5 Debra? Okay, thank you, Debra. We appreciate you 

6 taking the time to join us today. We're going --

7 MS. CLEMENT: Thank you very much.

8 CHAIR FAVRE: -- to go back, circle back 

9 to Farley Baricuatro. Farley, are you with us now?

10 MR. BARICUATRO: Yes, can you hear me 

11 now?

12 CHAIR FAVRE: Yes, we can.

13 JJF: Yay.

14 CHAIR FAVRE: Thank you, go ahead.

15 MR. BARICUATRO: Okay. That's good. 

16 Good afternoon. I am Farley Baricuatro with the 

17 FMC and I buy about 20,000 of dried seaweed for FMC

18 in a year. I would say that I represent the seaweed 

19 farm sector in tropical countries that now produce 

20 in excess of 250,000 dry pounds or 2.5 million wet 

21 pounds each year. Next slide please. 

22 Carrageenan harvesting is sustainable from farm to 
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1 vendor to producers to consumers. Carrageenan 

2 manufacturing uses seaweed varieties that have 

3 been consumed for hundreds of years in Asia, 

4 Africa, the Americas, and Europe, either eaten raw 

5 as a salad, cooked into dessert gels, or added as 

6 food thickeners without any reported deleterious 

7 effects.

8 For farmers, seaweed farming 

9 alleviates poverty, empowers women, provides 

10 independent farmers with positive economic 

11 position, helps in preserving the environment, 

12 promotes biodiversity, remains culturally 

13 significant. Seaweed farming also provides 

14 vendors and processors with benefits such as 

15 traceability. Next slide please. Seaweed is 

16 grown in farms by at least 75,000 farming families 

17 around the coasts of tropical countries like 

18 Indonesia, the Philippines, Vietnam, Malaysia, 

19 Tanzania, Madagascar, the Pacific Islands like 

20 Fiji and Kiribati and other countries.

21 Seaweed farmers are small stakeholders 

22 who use their own capital, relying on fast harvest 
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1 turnover of six weeks on average, 80 percent of the 

2 price goes to the farmers, making farming an 

3 attractive economic activity. These jobs allow 

4 farmers to care for their families and generate a 

5 multiplier effect in the final income in the 

6 communities. Seaweed farming is a platform for 

7 women empowerment. In Tanzania and Madagascar, 

8 where Muslim societies are dominated by men, 

9 seaweed farming is one arena where women are the 

10 major players, comprising 80 to 90 percent of the 

11 workforce.

12 Even in Southeast Asia, seaweed farming 

13 are shared by men and women. About 50 percent of 

14 the farms in Southeast Asia are mainly run by women. 

15 Sea farming is traditional in these societies. 

16 Seaweed farms have the capacity to grow with the 

17 market demand, so curtailing the use of carrageenan 

18 in the food industry would effectively render 

19 thousands of empowered individual farmers 

20 unemployed. There are no big monolithic corporate 

21 seaweed farms, only individual small scale farmers 

22 and their families will be hurt most.
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1 Seaweed farming is a green industry. 

2 It has low impact on the environment and it 

3 preserves coral reefs from activities that these 

4 farmers otherwise will engage in like fishing, fine 

5 net trolling. Seaweed grows only in clean waters 

6 and do not use pesticides, fertilizers, or 

7 synthetic inputs. You just tie seaweed in a line 

8 and it will grow like a weed in the sea. Seaweed 

9 farming promotes biodiversity as the farms are 

10 excellent breeding grounds for fish and marine 

11 organisms.

12 The species being grown in these 

13 seaweed farms in Asia and Africa are endemic to the 

14 location and are therefore non-invasive. These 

15 species are natural and non-genetically modified. 

16 And as we go up the supply chain, the players in 

17 the seaweed industry are implementing key roles in 

18 ensuring sustainability. Vendors or collectives 

19 are providing adequate working conditions, supply 

20 security, and traceability of their produce. 

21 Thank you.

22 CHAIR FAVRE: Okay. Thank you, Farley. 
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1 Anybody have questions for Farley? Okay, I don't 

2 see any. Thank you very much for your 

3 presentation.

4 MR. BARICUATRO: You're welcome.

5 CHAIR FAVRE: Okay, folks, we are going 

6 to circle back around to Helen Kees and then Amber 

7 King. Helen, are you with us?

8 HHK: I am.

9 CHAIR FAVRE: Okay. Please go ahead.

10 HHK: Good afternoon. As introduced, 

11 I'm Helen Kees, president of the Cornucopia 

12 Institute. And I'm speaking to you from our 

13 diversified family farm here in west central 

14 Wisconsin. Our farm name, Wheatfield Hill 

15 Organics, is in honor of the crop my grandfather 

16 grew on a bluff field that was heavy enough to raise 

17 wheat. I now stand on the shoulders of my 

18 foreparents with an awesome responsibility. I was 

19 formed in my mother's womb from this very soil and 

20 I am now interested with keeping it sacred enough 

21 to raise food fit to nourish other life. My 

22 grandchildren are the fifth generation to live and 
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1 work on our farm.

2 We are farmers. We have chosen to be 

3 certified organic farmers for the past 20 years. 

4 We have no full-time employees, family members 

5 constitute the labor for our farm, outside of some 

6 seasonal help. Our home farm consists of 320 

7 acres, with 100 tillable and 100 acres of pasture. 

8 We also lease another 345 acres. Year round, we 

9 husband 40 to 50 cow rotationally grazed beef herd, 

10 operate a farmstead processing kitchen, where much 

11 of our blueberry and raspberry crops are processed, 

12 and sell dairy quality alfalfa forage to other 

13 certified organic producers. In addition, we grow 

14 two acres of asparagus, 20 to 25 acres of corn and 

15 melons, and other traditional vegetables.

16 One of your newly seated Board members, 

17 Harriet Behar, has visited our farm as an organic 

18 inspector. Harriet is highly respected by our 

19 family and the extended organic community. I am 

20 thrilled that a sister Wisconsinite is sitting on 

21 the NOSB. Cornucopia Board member, Dr. Barry 

22 Flamm, was originally scheduled to speak in this 
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1 slot, however, due to a critical medical 

2 appointment, Dr. Flamm is not able to interface 

3 with you today.

4 Barry felt an obligation to address you 

5 because of his deep concern over your loss of 

6 authority due to the USDA unilaterally changing 

7 your policies and procedures. Not only as a past 

8 Chair of your Policy Committee, but also as the 

9 Chairman of the NOSB, Barry is uniquely qualified 

10 to make this judgment. He was intimately involved 

11 with the authorship of the policy and procedure 

12 manual in 2002. To say that Dr. Flamm is alarmed 

13 at the possibility that you may actually vote to 

14 codify this hijacking of your authority into your 

15 PPM is an understatement.

16 To draw a parallel, can you imagine your 

17 outrage if the Executive Branch of our Federal 

18 Government, possibly by Executive Order, rewrote 

19 the Constitution of the United States of America 

20 without any input or scrutiny from the Legislative 

21 Branch? Do you think the states would ratify such 

22 a change? Of course not. The Constitution itself 
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1 contains the instructions to guide any change or 

2 adaptation to the document. Likewise, in the 

3 past, when your PPM needed to be updated, the

4 process laid out in the manual itself guided and 

5 directed the process of the update.

6 Your PPM originally released in 2002 

7 was developed by you, for you, of you, in a 

8 transparent process with input from the organic 

9 community before any ratification by the USDA. 

10 Likewise, your 2012 update was conducted in the 

11 same manner. Personally, and I believe Dr. Flamm 

12 would agree, the USDA policy and procedure changes 

13 of 2015 is one of the largest cases of identity 

14 theft I have seen. Just because someone has stolen 

15 your identity does not mean that you should not 

16 fight to get it back and for farmers' sake, surely 

17 not vote to condone it. Please --

18 CHAIR FAVRE: Helen, excuse me. Helen, 

19 your time -- the timer went off a few seconds ago. 

20 We're going to need to wrap it up there. Thank you. 

21 Do we have any questions for Helen? Thank you. We 

22 appreciate it and we hope Barry is doing well. 
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1 Please give him our regards.

2 HHK: I'll pass your message on.

3 CHAIR FAVRE: Thank you. Next up will 

4 be Amber King. And that will be our last public 

5 commenter. Amber, are you with us?

6 MS. KING: Hi, can you hear me?

7 CHAIR FAVRE: Yes, we can. Please 

8 proceed.

9 MS. KING: All right. Thank you. Dear 

10 distinguished members of the NOSB, my name is Amber 

11 King. I am a chef, a mother, a small business owner 

12 selling organic personal care products and I work 

13 in the health and wellness community. I've been 

14 involved in multiple aspects of the food industry 

15 since I was 14 years old, from high end restaurants 

16 to a manager with the USDA Childcare Food Program 

17 to sales with the largest organic CSA program on 

18 the West Coast. I bring my requests and comments 

19 as a concerned citizen for upholding and 

20 strengthening USDA organic standards as an urgent 

21 matter of public health. I am addressing some main 

22 issues today in my comments.
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1 First of all, the unwanted ingredients 

2 in organics, such as carrageenan, cellulose, 

3 non-organic dyes and artificial flavors, as well 

4 as contamination by chemicals and new technologies 

5 in organic food and personal care products, and the 

6 impacts on children's health, and what we request 

7 be done about these issues. We do not believe the 

8 following substances should be in organic food: 

9 carrageenan.

10 We see these systems every day, we see 

11 our children, and we can argue study after study, 

12 I've listened to many of the comments today, and 

13 every day I live with seeing my daughter's reaction 

14 to carrageenan and hearing my friends talk about 

15 it with their children. Cellulose is just another 

16 one of these ingredients that we really consider 

17 not a food substance and we would want a non-GM 

18 product in its place that is organic and not causing 

19 a reaction.

20 Chlorine materials, disinfecting and 

21 sanitizing food surfaces, as well as artificial 

22 dyes and colors that cause allergic reactions, 
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1 neurological damage, and chronic inflammation and 

2 where these products are only benefitting the food 

3 manufacturers and they're not benefits of health 

4 to the end consumer. If it doesn't happen 

5 naturally and you cannot find a true organic 

6 product, the consumers are okay with not having 

7 these substances in our foods, regardless of mouth 

8 feel, of color or artificial flavor.

9 Also, acidified sodium chloride, a 

10 synthetic disinfectant made by DuPont, a synthetic 

11 DHA that is a strain of algae, synthetic vitamins 

12 and minerals, we do not find non-organic acceptable 

13 substitutes, including adding in of non-wild fish 

14 substances. I know the gentleman before spoke 

15 regarding fish oils and essential fatty acids that 

16 we want wild or natural products that are not 

17 synthetic in our organic foods.

18 We are also concerned about crisper 

19 technology that is not being evaluated or regulated 

20 by current USDA or FDA processes and, from a food 

21 standpoint, find that terribly discouraging. It 

22 is a very concerning situation and I hope the 
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1 National Organics Standards Board is taking into 

2 consideration and to not follow this path of 

3 advancement of technology to be allowed in organic 

4 standards.

5 I would really like to remind you that 

6 the National Organics Standards Board policy is to 

7 make decisions with the care of an ordinary prudent 

8 person in a similar position, and this law requires 

9 Board members to exercise the judgment of an 

10 ordinary person. That person is me, I am a mother 

11 and I am buying food for my family. We request the 

12 NOSB eliminate the phrase natural flavors on 

13 labeling of organic products that require the full 

14 ingredient list.

15 Our children's health and the reactions 

16 that they are having because of widespread 

17 inflammation due to GM and contaminated foods is 

18 -- their health really depends on it. My five year 

19 old daughter has skin sensitivities and I see them 

20 over and over again. The toxins in these foods not 

21 only affect our family's immediate health, they 

22 affect our future and the potential health of the 
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1 country. We understand you may not usually 

2 address these issues, but we need to come together 

3 and go beyond our usual responsibilities in these 

4 extraordinary circumstances. Thank you for 

5 taking time to protect organic standards and the 

6 health of our children and the future of this 

7 country.

8 CHAIR FAVRE: Great. Thank you very 

9 much, Amber, and we appreciate your patience in 

10 staying through to the end so you still had a chance 

11 to speak. I see that Harold Austin had a question. 

12 Harold, go ahead.

13 MEMBER AUSTIN: Thanks, Tracy. Amber, 

14 you made a comment when you were talking about 

15 carrageenan and then you moved into cellulose about 

16 this would remove the concern for the reaction. 

17 What specific reaction to the consumption of 

18 cellulose are you referring to?

19 MS. KING: For me, it's usually GM corn 

20 products or non -- I don't consider wood chips a 

21 food product. So I would look for something that 

22 is naturally occurring that is organic or can be 
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1 considered organic. So we're looking at rash 

2 reactions to these ingredients and additives.

3 MEMBER AUSTIN: Okay. So it would be 

4 the replacement of cellulose, not the cellulose 

5 itself?

6 MS. KING: Yes. From a better source 

7 that is able to be certified.

8 MEMBER AUSTIN: Okay. Thank you.

9 CHAIR FAVRE: Okay. Any other 

10 questions for Amber? Okay. Thank you, Amber. 

11 Folks, this brings us to the close of our webinar. 

12 We ran about ten minutes over, which I think is not

13 too bad given that it was a three hour webinar. We 

14 appreciate everyone joining us. Again, I want to 

15 reiterate how much I appreciate everybody 

16 participating in this webinar as I think this is 

17 an important opportunity for outreach and we look 

18 forward to hearing from you all again in helping 

19 us make our deliberations. And for those of you 

20 that we will see in Washington, D.C., we will see 

21 you in about a week. You all take care. Thank 

22 you.
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1 (Whereupon, the above-entitled matter 

2 went off the record at 4:11 p.m.)

3

4
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UNITED STATES DEPARTMENT OF AGRICULTURE

+ + + + +

NATIONAL ORGANIC STANDARDS BOARD

+ + + + +

SPRING 2016 MEETING

+ + + + +

MONDAY

APRIL 25, 2016

+ + + + +

The Board met in the Blue Room of the 

Omni Shoreham Hotel, 2500 Calvert Street, N.W., 

Washington, D.C., at 9:00 a.m., Tracy Favre, Chair, 

presiding.

PRESENT

TRACY FAVRE, Chair

TOM CHAPMAN, Vice Chair

HAROLD AUSTIN

CARMELA BECK

HARRIET BEHAR

A-DAE ROMERO-BRIONES

JESSE BUIE

LISA DE LIMA, Secretary

EMILY OAKLEY

SCOTT RICE

JEAN RICHARDSON

DAN SEITZ

ZEA SONNABEND

ASHLEY SWAFFAR

FRANCIS THICKE
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ALSO PRESENT

MICHELLE ARSENAULT, Advisory Board Specialist, 

National Organic Program

LISA BRINES, National List Manager, National 

Organic Program

EMILY BROWN ROSEN, Agricultural Marketing 

Specialist, National Organic Program

PAUL LEWIS, Director, Standards Division, 

National Organic Program, USDA 

MILES McEVOY, Designated Federal Officer, Deputy 

Administrator, National Organic Program

ELANOR STARMER, Administrator, Agricultural 

Marketing Service 

STACY TOLLEFSON, University of Arizona, 

 Hydroponics Task Force

JOHN BIERNBAUM, Michigan State University, 

 Hydroponics Task Force
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T-A-B-L-E O-F C-O-N-T-E-N-T-S

Call to Order and Agenda Overview

Miles McEvoy ................................. 4

Tracy Favre .................................. 4

Jean Richardson .............................. 6

Introductions ................................. 7

Introduction and Welcome

Elanor Starmer .............................. 26

Betsy Rakola ................................ 37

Secretary's Report

Lisa de Lima ................................ 50

National Organic Program Report

Miles McEvoy ................................ 51

National Organic Standards Board Report

Tracy Favre ................................. 87

National Organic Program - Materials

Update/Summary of New and Outstanding Petitions

Lisa Brines ................................. 93

Hydroponics Task Force Update ............... 106

Public Comments ............................. 148

Lunch

Public Comments (cont.) ..................... 192

Adjourn
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1 P-R-O-C-E-E-D-I-N-G-S

2 9:01 a.m.

3 MR. McEVOY: Okay. We're going to get 

4 started. 

5 Okay. Good morning, everyone. 

6 Welcome to Washington, D.C. Beautiful spring day 

7 here. I hope you get some time to enjoy the 

8 beautiful sights in Washington, D.C. It's really 

9 an amazing city, especially this time of year. 

10 Lots of flowers, lots of the birds are coming north. 

11 If you're a bird watcher, Rock Creek Park right 

12 here, right by the hotel is a birding hot spot for 

13 warblers. It'll be thousands of them coming 

14 through, dozens of species of warblers. So if 

15 anybody wants to talk to me more about that during 

16 a break, you know who to talk to.

17 So I'm Miles McEvoy, Deputy 

18 Administrator for the National Organic Program in 

19 the Agricultural Marketing Service, also the 

20 designated federal officer for the National 

21 Organic Standards Board. Welcome to the Spring 

22 National Organic Standards Board Meeting 2016. 
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1 And with that, I'll turn it over to 

2 Tracy Favre.

3 CHAIR FAVRE: Good morning. Thanks 

4 everyone for joining us today here in Washington, 

5 D.C. We really look forward to an opportunity to 

6 have a supportive meeting of organic agriculture 

7 through a very productive meeting today, or this 

8 week. 

9 On my farm in Texas this is actually one 

10 of the most beautiful months with lush green grass, 

11 our newborn lambs on the ground and our bees 

12 foraging for pollen and nectar from all the wild 

13 flowers that are on the ground. And I'm really 

14 struck at this time of the year by why we're doing 

15 what we're doing at this meeting. 

16 As I look out on all of you, I'm really 

17 struck by the fact that we're all here for the same 

18 reason, and that is to build a robust organic 

19 movement that enjoys the highest consumer 

20 confidence and offers a sustainable livelihood for 

21 farmers and their families while protecting the 

22 environment and this world that we live in. 
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1 That's a giant undertaking and we all 

2 have our roles to play, but I truly believe that 

3 we are stronger together than we would be apart in 

4 this. We're all mavericks in this room, bucking 

5 the mainstream to pursue this goal, and in that 

6 spirit I'd like to invite Board member Dr. Jean 

7 Richardson to start us off with an inspirational 

8 reading. 

9 Jean?

10 MEMBER RICHARDSON: I'm going to be 

11 reading a poem which most of you are going to know 

12 quite well: Robert Frost's "The Road Not Taken," 

13 and it can be attributed in many ways, so when you 

14 listen to it, as you listen to it, I would like you 

15 to try to think of yourself as one of those leaders, 

16 one of those mavericks. Whoever you are, farmer, 

17 certifier, trouble maker, NOP, NOSB members, all 

18 of you, try to put yourself into this poem and 

19 remember that you took the road less traveled, 

20 which makes you a rather special person and 

21 inspiration to all of us, too.

22 "Two roads diverged in a yellow wood, 
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1 And sorry I could not travel both

2 And be one traveler, long I stood 

3 And looked down one as far as I could

4 To where it bent in the undergrowth;

5

6 "Then took the other, as just as fair,

7 And having perhaps the better claim,

8 Because it was grassy and wanted wear;

9 Though as for that the passing there

10 Had worn them really about the same,

11

12 "And both that morning equally lay 

13 In leaves no step had trodden black.

14 Oh, I kept the first for another day!

15 Yet knowing how way leads on to way,

16 I doubted if I should ever come back.

17

18 "I shall be telling this with a sigh

19 Somewhere ages and ages hence:

20 Two roads diverged in a wood, and I --

21 I took the one less traveled by,

22 And that has made all the difference."
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1 CHAIR FAVRE: Words to remember as we 

2 inform this week what we do here makes all the 

3 difference. 

4 Okay. I'd like to start with an 

5 introduction of our table here, NOP staff and Board 

6 members, and we're going to start down at this end 

7 of the table with our support, Michelle Arsenault.

8 Go ahead.

9 MS. ARSENAULT: I wasn't expecting 

10 that. Welcome everyone. Good to see all of the 

11 familiar faces. 

12 How many people have not been to an NOSB 

13 meeting before?

14 (Show of hands.)

15 MS. ARSENAULT: All right. Look 

16 around you and see all the hands that are not up. 

17 If you have any questions, these guys are old hat 

18 and can answer any questions you may have.

19 Welcome. I hope we all have a really 

20 great meeting.

21 MS. BROWN ROSEN: Hi, I'm Emily Brown 

22 Rosen. I work with the Standards Division and I 
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1 also spend a lot of time on the phone with the NOSB 

2 Subcommittees, helping them out and giving them a 

3 little technical support. Thanks. 

4 MEMBER AUSTIN: Harold Austin. I'm 

5 with Zirkle Fruit. I sit in one of the two handling 

6 positions. I am the current chair of the Handling 

7 Subcommittee. And I just have to say thanks to all 

8 of you for the well wishes. Last year about this 

9 same time I was quite sitting upright, but laying 

10 in a hospital bed with a busted femur. I got to 

11 say it's really nice to be here back in person, 

12 being able to see and mingle and talk with each and 

13 every one of you. 

14 (Applause.)

15 MEMBER AUSTIN: Thank you.

16 MEMBER BUIE: I'm Jesse Buie. I'm 

17 President of Old Brook Organics in Brookhaven, 

18 Mississippi, and I presently sit in one of the 

19 producer slots. I'm really honored to have this 

20 opportunity to be here. And I guess we have a 

21 couple of slides. I'm certified in mixed 

22 vegetables and melons. I have a contract with 
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1 Rainbow, Whole Foods and Fresh Market in 

2 Mississippi where I basically grow squash, yellow 

3 meat watermelons -- that is -- what we have on there 

4 is turmeric. I grow two types --

5 (Off microphone comment.)

6 MEMBER BUIE: Okay. Where I this year 

7 grew two types of turmerics, the regular organic 

8 turmeric and a white mango turmeric and a Blue Baba 

9 ginger. And it was a kind of experiment and we had 

10 some success. The only problem is we -- in 

11 Mississippi it's a seven-month growing period, and 

12 those products need nine months. So this year we 

13 have a high turnover and hopefully we'll have 

14 better success.

15 The farm is part of the Buie Family 

16 Trust, which is a total of 200 acres, and I'm proud 

17 to say that we do have our original 40 acres and 

18 a mule. The mule's been dead for about 145 years --

19 (Laughter.)

20 MEMBER BUIE: -- but -- and this was 

21 through my mother's ancestry, Austin Buie. 

22 So and I've been in farming for over 55 
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1 years, and I just want to give a little perspective 

2 of where I come from. The other one, the French 

3 breakfast -- that's my other product. That's a 

4 French breakfast radish that we also produce and 

5 sell.

6 But to move this thing along, I've been 

7 in farming for over 55 years. I've also been in 

8 health care administration. And I say all this to 

9 kind of give a perspective from where I come from.

10 When I started out, I went to the State 

11 of Mississippi and said I wanted to -- I want to 

12 be organic. They immediately told me there was 

13 nothing they could do for me. And not only that, 

14 they didn't know I could ask. So from that I 

15 started to do the research. I got a lot of help 

16 from people outside of the state. So I'm really 

17 motivated because when I started this process, it 

18 was the USDA symbol I was looking at, and it meant 

19 a lot to strive for that.

20 Sitting on this board here, that's what 

21 I want to make sure continues, that integrity, 

22 because when I had my inspection this summer, the 
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1 inspector said, Jesse, we have a surprise for you. 

2 You've been selected for a spot test. And so all 

3 of a sudden they start pulling up all my plants and 

4 stuff. 

5 But the bottom line is this is what it's 

6 all about: the documentation of quality. And 

7 hopefully that's one thing that I can be a part of 

8 assuring, that USDA label means integrity. So as 

9 a member here I would hope to strive to do 

10 everything I can to make sure that the label means 

11 what people out there think it means and what it 

12 should mean. So thank you very much.

13 MEMBER BECK: Good morning. My name 

14 is Carmella Beck. I'm the Organic Program Manager 

15 at Driscoll Strawberry Associates. We're a 

16 100-plus-year family-owned business, working with 

17 independent farmers to distribute both organic and 

18 conventional strawberries, raspberries, 

19 blackberries and blueberries, and we're based out 

20 of Watsonville, California. It's a pleasure to be 

21 here today.

22 MEMBER SWAFFAR: Hi, I'm Ashley 
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1 Swaffar. I sit in a producer seat and I'm the 

2 current Chair of the Livestock Committee. I own 

3 a small certified mixed vegetable farm in Arkansas, 

4 and I've worked with organic and pasture-based egg 

5 producers.

6 MEMBER ROMERO-BRIONES: (Native 

7 language spoken.) My name is A-dae Romero-Briones 

8 and I come from the village of Cochiti Pueblo, New 

9 Mexico, but I currently reside on the Island of 

10 Lana'i in Hawaii, and I work with indigenous 

11 farmers both through First Nations Development 

12 Institute and Pulama Lana'i. My primary job on 

13 Lana'i is to develop food and agricultural 

14 businesses for the island. First Nations 

15 Development Institute, I work with indigenous 

16 farmers throughout the country on developing 

17 businesses and creating agricultural-based 

18 reservation economies. 

19 The picture is my village, Cochiti 

20 Pueblo, New Mexico. That is three of our buffalo 

21 and some of our agricultural lands. Our primary 

22 crop is indigenous varieties of corn and different 
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1 varieties of grasses. Thank you.

2 MEMBER DE LIMA: Good morning. I'm 

3 Lisa de Lima. I serve in the one and only retailer 

4 seat on the Board. This is my second year. I work 

5 at MOM's Organic Market. We're a local 

6 independently-owned and operated chain here in 

7 D.C. and Maryland and Northern Virginia. And I've 

8 been in organic retail for 19 years.

9 VICE CHAIR CHAPMAN: Hello, my name is 

10 Tom Chapman. I'm the Vice Chair of the NOSB, Chair 

11 of the Policy Development Subcommittee and I sit 

12 in a handler seat. I'm a senior sourcing manager 

13 for ingredients at Clif Bar, based in Emeryville, 

14 California. Organic agriculture is a core value 

15 of Clif Bar under our five aspirations. And to 

16 give you guys a sense, today we purchase over 640 

17 million pounds of organic ingredients avoiding 5 

18 million pounds of pesticides over 30,000 acres of 

19 organic farmland.

20 MEMBER SEITZ: Good morning, everyone. 

21 My name is Dan Seitz and I fill a public interest, 

22 consumer slot on the NOSB. And this is my first 
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1 meeting, and I am delighted and honored to be on 

2 the NOSB.

3 First of all, I just want to say that 

4 I live in the beautiful Berkshire region of Western 

5 Massachusetts. On this slide you can see a view 

6 from one of our hills or mountains, depending upon 

7 your point of view. That's Monument Mountain, 

8 famous for Nathaniel Hawthorne and Herman Melville 

9 having taken a walk in 1850 up the mountain and 

10 being stuck in a cave due to a thunderstorm. And 

11 as a result, Herman Melville conceived the idea of 

12 Moby Dick, or at least he added to his thoughts on 

13 what to write about.

14 I'll say that I think during my five 

15 years on the Board here I won't have time to reread 

16 Moby Dick. 

17 (Laughter.)

18 MEMBER SEITZ: Being on the Board 

19 represents a number of my professional and personal 

20 interests. I serve on the Board of a food co-op 

21 in Great Barrington where I live, and we focus on 

22 sourcing our food sustainably, organically, 
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1 locally. 

2 Also, for the last 30 years I've been 

3 involved with natural alternative, complementary, 

4 integrated medicine. There are different terms 

5 for that. Currently serving as the executive 

6 director for the Council on Naturopathic Medical 

7 Education and also consulting and advising others 

8 in homeopathy, Ayurvedic medicine, yoga therapy 

9 and nutrition. And at the heart of all of these 

10 different fields is the understanding that 

11 nutrition, good nutrition is really a primary 

12 source of good health. In fact the father of 

13 Western Medicine, Hippocrates, said let food be thy 

14 medicine and let thy medicine be food. And I think 

15 if Hippocrates was living today, he would say let 

16 organic, sustainably produced food be thy 

17 medicine, and let that medicine be organic 

18 sustainably produced food.

19 And finally, I want to say that I'm also 

20 excited to be on the Board because it's going to 

21 be an opportunity for a crash graduate-level course 

22 in chemistry, biochemistry, ecology, agronomy; 
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1 I've let out some others, as well as political 

2 science. So I'm going to learn a lot. And again, 

3 delighted to be part of this community. 

4 MEMBER RICHARDSON: Good morning 

5 again. Jean Richardson. This is my fifth and 

6 final year on the Board. I have a few things that 

7 I'd like to accomplish yet. I'm a professor 

8 emerita of environmental studies and environmental 

9 law, University of Vermont. And I've been an 

10 organic inspector for 16 years, and I am from the 

11 great little State of Vermont that brought us all 

12 a GMO labeling bill.

13 (Applause.)

14 MEMBER BEHAR: I'm Harriet Behar. I 

15 come from Gays Mills, Wisconsin. I'm sitting in 

16 the conservation/natural resources seat, but many 

17 of you know me as many different things. I've been 

18 an organic inspector. I am a certified organic 

19 farmer since 1989. Michelle is going to put some 

20 pictures up. I'm also an organic educator. This 

21 is my 10th year working for MOSES. 

22 But really my most important job is 
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1 being a steward of the land. And on my farm we 

2 produce all the electricity that we need for our 

3 farm. I have a solar greenhouse you see there, and 

4 it's full of plants. And I thank my husband for 

5 keeping them watered and alive. We also grow and 

6 dehydrate herbs. I sell to soap makers and tea 

7 makers and my local food co-op.

8 Next slide. But also we're also 

9 beekeepers. We have over 30 hives. And we do a 

10 lot of work on our land as well as teaching other 

11 people about doing natural resource conservation. 

12 So we have put in over 25 acres of native prairie. 

13 That stream there, we did a lot of work in the past 

14 three years improving the habitat for naturally 

15 reproducing brook trout. We have chickens. We 

16 sell eggs. I think there might be some of my egg 

17 customers in the audience. 

18 And really, like I said, the most 

19 important thing that we do is steward our land. 

20 And I help educate farmers, ag professionals, 

21 processors, handlers and consumers about the 

22 benefits of organic. And it's not just only about 
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1 the food you eat, but the way it's produced and 

2 keeping the resources, maintaining and enhancing 

3 them for future generations. 

4 So thank you. And it's the first time 

5 on the other side of the podium here, so thank you 

6 to all my friends in the audience.

7 MEMBER SONNABEND: Hello. I'm Zea 

8 Sonnabend. I hold the scientist seat on the Board. 

9 I am with a small organic farmer with a 20-acre 

10 diversified fruit farm called Fruitilicious Farm, 

11 growing apples, figs, quince, citrus, blueberries 

12 and pears, as well as about an acre of vegetable 

13 crops for seed production.

14 I serve as a policy specialist and 

15 inspector with CCOF, and this is my fifth of five 

16 years on the NOSB as the scientist seat, which I 

17 hold from a long career of reviewing materials for 

18 compatibility with organic systems.

19 MEMBER RICE: Good morning. My name 

20 is Scott Rice. I'm a USDA accredited certifying 

21 agent representative on the Board. I'm the 

22 Accreditation and Outreach Manager for the 
20

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1 Washington State Department of Ag Organic Program. 

2 And WSDA is the oldest and largest certifier, 

3 currently certifying about 1,100 operations in all 

4 scopes and a tremendous diversity of crops in our 

5 state. Apples, as Harold will agree, figure 

6 prominently there.

7 The next slide is an orchard in the Chelan area, 

8 northern part of the state. 

9 I've been with WSDA for the past nine 

10 years. And as many of my certifier colleagues can 

11 attest, if you've been in certification long enough 

12 you've covered just about every role from inspector 

13 to reviewer, compliance manager to input materials 

14 review and just about everything else, and my 

15 experience is no different. I get to the end of 

16 some days and feel like I've filled all of those 

17 roles. And that's why we're in the work, though. 

18 It's what makes it interesting and rewarding.

19 I also serve as the Chair of the 

20 Accredited Certifiers Association. It's an 

21 organization of 50 domestic and international 

22 USDA-accredited certifiers. We work together to 
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1 protect the integrity of the organic label and 

2 ensure consistent implementation of the standards. 

3 Each year our organization hosts an in-depth 

4 professional development training in conjunction 

5 with NOP's certifier training where we dive into 

6 some of those issues that we face every day and work 

7 through them together. 

8 I graduated from the Evergreen State 

9 College in Olympia, Washington, home of the 

10 fighting Geoducks, where I focused on sustainable 

11 ag --

12 (Applause.)

13 MEMBER RICE: -- thank you, and food 

14 and community studies. I've worked in organic and 

15 sustainable ag for the last 20 years. It's an 

16 experience that started as an apprentice on a 

17 beautiful piece of land in Western Sonoma County 

18 in California, and it's continued through work with 

19 the Organic Materials Review Institute. I managed 

20 the farm program at Pike Place Market for several 

21 years and have overseen production of a large 

22 asparagus operation and continues with my work at 
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1 WSDA today.

2 I'm excited to be here and really 

3 honored to be a part of this board and work on behalf 

4 of the organic sector. Thank you.

5 MEMBER OAKLEY: My name is Emily Oakley 

6 and I'm serving as a farmer representative, but I'm 

7 also a dedicated consumer of organic foods, and 

8 that's an important part of my perspective as well. 

9 This is my full-time job. I am 

10 starting or I'm in my 13th season of farming in 

11 Oklahoma. I own 20 acres. I farm about three in 

12 annual crops and about two in perennial fruits and 

13 asparagus. And that is a challenge in Oklahoma. 

14 The rest of the land is in dedicated wildlife 

15 habitat. We have about an acre in wild flowers 

16 that are native and native edible fruits as well. 

17 That's a really important part of what we do. 

18 It's my full-time job. We have no 

19 off-farm income. It's a two-person operation, 

20 which is a big part of our philosophy. And we are 

21 also direct market farmers, so we sell directly to 

22 our consumers through one farmer's market and 
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1 through a CSA of about 120 members.

2 Next slide. Thank you. I just want to 

3 show you some more of our pictures of our farm to 

4 give you a sense of where I'm coming from. I've 

5 been involved in organic and sustainable 

6 agriculture for the last 22 years, through both 

7 college and graduate school working with community 

8 garden organizations. 

9 And in my "off season," which is in 

10 quotes, because you're never in an off-season, but 

11 during our winter months we spend a good deal of 

12 time doing farmer-to-farmer exchanges 

13 internationally working with farmers on organic 

14 agriculture issues and having the pleasure of 

15 having people to come to our farm as well to 

16 reciprocate that exchange. 

17 I look forward to meeting all of you 

18 over the next couple of days. And this is my first 

19 NOSB meeting and I hope I can do a good job of 

20 serving the diverse stakeholders that are involved 

21 in this movement. And please share your comments 

22 with me at any point if you have questions or 
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1 concerns. Thank you.

2 MEMBER THICKE: Emily, it looks like 

3 there aren't any weeds in Oklahoma.

4 I'm from Iowa and I sit in an 

5 environmentalist seat. I have an organic 

6 grass-based dairy farm. I milk about 90 cows, 

7 which are going out to pasture about now, not by 

8 my work. But usually I am there. And we process 

9 our milk on the farm. We make bottled milk and 

10 yogurt and cheese, and we market it all within three 

11 miles or four miles of the farm.

12 CHAIR FAVRE: And I'm Tracy Favre, 

13 current Chair of the Board, former Livestock and 

14 PDS Subcommittee Chair. I'm a 20-year veteran of 

15 the environmental engineering field; I'm a 

16 registered professional and engineer in the State 

17 of Texas. My husband and I operate a diverse 

18 family farm in North Central Texas outside of the 

19 Dallas/Fort Worth area, including some grass-based 

20 farm-raised lamb, pastured laying hens, bees, 

21 fruit and vegetable gardens, fruits, and I'm also 

22 an organic inspector.
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1 I think you can see we've got a 

2 fantastic new cohort of board members coming in. 

3 I'm really excited. I think we got a great group 

4 this year, and we've got some fresh meat to get some 

5 of the work done for the Board.

6 (Laughter.)

7 CHAIR FAVRE: I'd like to now turn it 

8 over to AMS Administrator Elanor Starmer for an 

9 introduction and welcome. We're delighted to have 

10 her here today.

11 MS. STARMER: Thank you so much, Tracy.

12 It's wonderful to be here. It's 

13 wonderful to see so many new faces and also a lot 

14 of familiar faces, or in Marty's case a familiar 

15 t-shirt.

16 I have worked on this -- in this area 

17 for many years prior to coming to USDA in 2011, when 

18 I came in working for Deputy Secretary Kathleen 

19 Merrigan and then moved over to be senior advisor 

20 to Secretary Vilsack a couple years later. I just 

21 joined AMS in February of this year, and I could 

22 not be more thrilled to have landed in this agency. 
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1 I have gotten up to speed quite quickly 

2 on the work that the Board does and just want to 

3 thank the members of the Board and welcome the 

4 incoming members for all of the time and effort that 

5 you've put into this very important work. 

6 And I also want to thank every else in 

7 the audience for being here as well. It is so 

8 important that you are here and engaging, and we 

9 really appreciate that. Public participation, 

10 including meetings like this, is really vital to 

11 the process that all of us are invested in as we 

12 work to protect the integrity of the organic seal.

13 As I mentioned, this is work that's very 

14 close to my heart. I grew up in a small community 

15 of about 700 people just south of the White Mountain 

16 National Forest in New Hampshire. My next door 

17 neighbors were early certified organic farmers, 

18 and I grew up working on their farm. 

19 It's a small operation. They do mostly 

20 direct to consumer, a little bit of restaurant and 

21 retail. And they have one spouse working off the 

22 farm. But through both good times and bad, they 
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1 have always maintained their organic 

2 certification. And in talking with them and in 

3 working on the farm I came to learn the value of 

4 that certification in terms of the practices that 

5 it represents and in terms of the market 

6 opportunities that it creates. And that's really 

7 a lot of what drives me in the work here and one 

8 reason why I'm so excited to now be in a position 

9 to be able to work closely with our National Organic 

10 Program.

11 USDA strongly supports organic 

12 agriculture and we are committed to establishing 

13 a level playing field that protects all organic 

14 farms and businesses. I'm going to talk a little 

15 bit more broadly about this in a moment, but I want 

16 to start with a timely and specific example. 

17 One of my first acts as administrator was to 

18 sign the proposed rule on organic livestock and 

19 poultry practices, which was published about two 

20 weeks ago, and aims to clarify how organic 

21 producers and handlers must treat livestock and 

22 poultry to ensure their health and well-being 
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1 throughout life, including transport and 

2 slaughter.

3 This proposal grew out of a number of 

4 recommendations from the NOSB, and the Board's work 

5 was vital to the development of the rule. The rule 

6 is intended to strengthen consumer confidence in 

7 the organic label and to provide clear and fair 

8 guidance to livestock and poultry producers so that 

9 they can benefit from the economic opportunities 

10 that the organic market provides. 

11 The proposed rule is one example of what 

12 makes our work in organic so impactful, and that's 

13 the fact that it's a process -- as Tracy mentioned 

14 -- that we engage in together. The rule grew out 

15 of a number of recommendations, as I said, from the 

16 NOSB, as well as extensive input from the organic 

17 community and stakeholders. We've taken 

18 that input and developed a proposal that we think 

19 is responsive, but the process does not end here. 

20 I hope you'll take the time to submit public 

21 comments and review the proposal. That's the best 

22 way to improve the final rule.
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1 Throughout the history of the Organic 

2 Program, yours and others' engagement in the 

3 rulemaking process has been vital to shaping the 

4 very meaning of organic. It's something that we 

5 all have ownership over as a result of that 

6 engagement. And in turn, that shapes the value 

7 that it provides to farmers and ranchers, to 

8 businesses and to communities. I'm very excited 

9 to engage with you all as we move forward with this 

10 important piece of the work, and I thank you for 

11 your partnership on it.

12 I also want to acknowledge --- and 

13 you'll sort of sense a theme here -- how important 

14 your engagement and partnership have been to 

15 shaping USDA's overall work in support of organic 

16 agriculture. The organic community recognized a 

17 need to make organic certification more 

18 accessible, affordable and attainable, and in 2013 

19 USDA launched the Sound and Sensible Initiative, 

20 which has helped to streamline the certification 

21 process, to strengthen our enforcement activities 

22 and has boosted our work with farmers and 
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1 processors to correct small issues before they 

2 become large ones.

3 In partnership with 14 organizations 

4 around the country, we also published a series of 

5 Sound and Sensible resources to help farmers and 

6 ranchers become familiar with the requirements of 

7 organic certification before they engage in the 

8 process and to access educational and technical 

9 tools as they engage in it. 

10 We've also recognized, as you have, 

11 that meeting the requirements for organic 

12 certification can take time, effort and money. So 

13 in partnership with state Departments of 

14 Agriculture, we offered the Organic Certification 

15 Cost Share Program. Last week we announced that 

16 a total of almost $12 million is available to 

17 organic farms and businesses nationwide to cover 

18 up to 75 percent of an individual applicant's 

19 certification costs, to a maximum of $750. Each 

20 state has its own guidelines and requirements for 

21 reimbursement, and so folks who are interested can 

22 work directly with their state agency. But that's 
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1 just one example of the ways in which we are trying 

2 to work together to make certification more 

3 accessible.

4 I'm also very pleased that recently 

5 we've launched the Organic INTEGRITY Database. 

6 This is a modernized system for tracking certified 

7 organic operations. In the past USDA published an 

8 updated list of these operations once a year, but 

9 with the new database -- which was made possible 

10 by the passage of the 2014 Farm Bill -- organic 

11 certifiers can add new operations and report 

12 changes to existing operations at any time, 

13 allowing USDA to report updated counts of certified 

14 operations throughout the year. 

15 The database is a great tool for market 

16 research. It enables stakeholders to identify 

17 market opportunities and make connections across 

18 the supply chain. It supports international 

19 verification of operator status to facilitate 

20 trade and it allows certifiers to share more 

21 accurate and timely data electronically. 

22 According to the new data there are now over 31,000 
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1 certified organic producers and handlers around 

2 the world, including nearly 22,000 here in the 

3 United States.

4 In addition to the data on operations 

5 that we're now providing through the Organic 

6 INTEGRITY Database, AMS Market News is now 

7 publishing pricing data across the country for over 

8 250 different organic products, to help bring 

9 greater transparency to the marketplace.

10 USDA also continues to expand markets 

11 for American organic products abroad, adding to the 

12 list of agreements that increase market access for 

13 U.S. producers. During this administration, 

14 we've secured trade arrangements for organic 

15 products with Canada, the European Union, Japan, 

16 Korea and Switzerland.

17 We also know from talking with you that 

18 there are a lot of USDA programs that are critical 

19 to organic producers and over which AMS has very 

20 little control -- things like crop insurance, 

21 credit, on-farm research activities. It's so 

22 important to the success of organic producers that 
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1 the USDA is integrating organic priorities across 

2 all of our agencies, and that all of these pieces 

3 of the puzzle are working for organic.

4 So for a number of years AMS has 

5 invested in a full-time employee -- Betsy Rakola, 

6 who I know many of you know, who's going to speak 

7 to you shortly -- to work across USDA so that the 

8 whole institution can better meet the needs of the 

9 organic sector. I'm not going to go into detail 

10 about the accomplishments we've been able to make 

11 there, because she's going to be talking to you 

12 about them, but suffice it to say I think we've seen 

13 unprecedented change within the institution of 

14 USDA over the last six or seven years as a result 

15 of this work, which has been very, very exciting. 

16 And you can find a lot of the 

17 information about cross-USDA efforts to support 

18 organic through the National Organic Program and 

19 the One-Stop Shop we've created at 

20 usda.gov/organic.

21 I also just quickly want to mention 

22 because this used to be my job when I was in the 
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1 Secretary's office that the Department also has a 

2 full-time senior staff person doing the same type 

3 of work across USDA to support local and regional 

4 food systems. This position has been a 

5 term-limited political appointment. We're soon 

6 going to be advertising to make it a permanent 

7 career position, just like Betsy's, which I think 

8 is going to help institutionalize all of this work 

9 as we transition across administrations.

10 Many organic producers, like my 

11 neighbors in New Hampshire, get their start or stay 

12 in local markets, and it's really critical that 

13 they have access to tools like crop insurance that 

14 accurately reflects the value of their crops, 

15 research relevant to diversified smaller scale 

16 operations, and local or regional supply chain 

17 infrastructure that's scale- appropriate to help 

18 bring their products to market. 

19 We've made tremendous progress in this 

20 regard across USDA, making over $1 billion in local 

21 food investments since 2009, and I know this is 

22 progress that benefits many in the organic 
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1 community as well.

2 Now, USDA and AMS provide a lot of 

3 support for organic agriculture, but the National 

4 Organic Program's focus is on protecting the 

5 integrity of the USDA organic seal, and this means 

6 clearly defining what it means to be organic and 

7 enforcing those rules. The NOP is dedicated to 

8 that mission through its work on standards 

9 development, accreditation of certifying agents, 

10 oversight of organic trade arrangements, and the 

11 ongoing work that we do on compliance and 

12 enforcement. 

13 This is something that's particularly 

14 important to me in this role as the AMS 

15 administrator. It's through enforcement that we 

16 can ensure that consumers are getting organic 

17 products that comply with USDA organic regulations 

18 and that all organic producers and handlers have 

19 a fair market place in which to operate.

20 I'm now going to turn things over to 

21 Betsy to talk a little bit about her work as the 

22 Department's organic policy advisor and some of the 
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1 accomplishments that we've seen through the 

2 Organic Working Group, and how these organic 

3 priorities are being integrated across USDA. 

4 But again, I really want to thank you 

5 for having me here today. I wish you a very 

6 productive meeting. I particularly want to thank 

7 the members of the NOSB for your service. And 

8 again, I thank everyone in the room for your 

9 engagement. It is so important. I look forward 

10 to seeing the outcomes of the meeting and to 

11 partnering with you in the months to come. Thank 

12 you.

13 (Applause.)

14 MS. RAKOLA: Good morning, everyone. 

15 Good morning to the Board. Thank you for having 

16 me here. Again, my name is Betsy Rakola. I am the 

17 organic policy advisor to the Secretary and my 

18 job -- Miles and I often describe it that sort of 

19 my job picks up where his leaves off, that I work 

20 with the pieces of USDA beyond the NOP to try to 

21 institutionalize support for organic agriculture 

22 throughout the Department.
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1 I see a lot of familiar faces. I saw 

2 a lot of hands up for those of you who are here for 

3 the first time. So whether you're an old hat or 

4 a newbie, we're glad that you're here. For those 

5 who don't know me, I have been with USDA for about 

6 six years. And prior to my current role I was a 

7 part of the National Organic Program, first 

8 managing the Certification Cost Share Programs and 

9 then as an accreditation auditor.

10 So I'm going to cover a lot of 

11 information very quickly out of respect for time. 

12 I want to make sure that we're talking less and 

13 listening more. So all that to say that there is 

14 going to be a lot of information here, and if anyone 

15 has any questions I will be here today and tomorrow, 

16 and I do have my email at the end of the 

17 presentation. I'd be happy to follow up with you 

18 on it. But I just want to give a very quick and 

19 broad overview of what's going on across the 

20 Department. 

21 So the broad framework for what we do 

22 on organic agriculture is encapsulated in USDA's 
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1 Strategic Plan, which actually does have specific 

2 goals for organic agriculture. The main metric 

3 that we have is to achieve 20,000 certified organic 

4 operations in the United States by 2018. For those 

5 who were listening closely to Elanor's remarks, you 

6 may have heard that we actually blew that out of 

7 the water. We achieved it two years early and 

8 we've already exceeded that goal. So we're very 

9 excited about that.

10 But I think the plan does lay out a great 

11 strategy for how it is that we want to support the 

12 sector. So we focus on research and education, 

13 outreach through our field offices and risk 

14 management tools with a broad goal of reducing 

15 paperwork and making certification simpler, more 

16 sound and sensible, so that the organic market is 

17 accessible to small and beginning farmers.

18 So we do this through a structure that 

19 we call the Organic Working Group. The working 

20 group is internal to the USDA. Elanor Starmer, our 

21 AMS administrator, is the executive leader of the 

22 working group, and we have members from all of our 
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1 different agencies. And we set various goals. We 

2 have teams working on different themes all trying 

3 to come together across what often end up sort of 

4 being silos in the Government, making sure that we 

5 can collaborate to make sure that we're supporting 

6 organic and providing organic producers and 

7 handlers with the programs and services that they 

8 need to succeed.

9 I want to highlight the fact that we 

10 often welcome external speakers. We have a number 

11 of informal brown bag lunches or other 

12 presentations, so if you're ever in the D.C. area 

13 and you have some information that you'd like to 

14 share with us, please reach out to me. We'd love 

15 to have you. It's always great to have fresh faces 

16 and some outside voices to let us know what's 

17 happening out in the field.

18 So a quick run through some of the 

19 accomplishments that we've had recently at USDA, 

20 starting with our marketing programs.

21 Earlier, I believe just at the end of 

22 2015, we passed what's called the Organic Exemption 
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1 Rule. So this was something that was laid out in 

2 the Farm Bill to extend the exemption for organic 

3 producers and handlers from our research and 

4 promotion programs and our marketing orders. 

5 So previously the exemption only 

6 applied to those producing and handling solely 

7 organic products and now it applies to anyone who 

8 is producing or handling organic products. We're 

9 very happy to have that benefit for the organic 

10 sector.

11 We've had a number of accomplishments 

12 in our conservation programs. Our Natural 

13 Resources Conservation Service has done a lot to 

14 bridge the gap between conservation planning and 

15 organic agriculture. The capstone of this was 

16 really the "National Organic Farming Handbook," 

17 which was published this last summer that clearly 

18 walks through the conservation practices 

19 established by the NRCS and lines them up with 

20 organic farming regulations. It's a great tool 

21 that makes it clear for both our field-based 

22 conservation planners and organic producers, how 
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1 these things work hand-in-glove. And it includes 

2 a wealth of helpful resources to figure out how to 

3 get from idea to on-the-ground implementation.

4 We've also done a lot in terms of 

5 capacity building with a focus on our field staff. 

6 There is an ongoing webinar series that is open to 

7 the public that targets NRCS staff talking about 

8 a number of topics. And last year we focused on 

9 the environmental benefits of organic agriculture. 

10 Anyone who's interested in that can go to the NRCS 

11 web site, and you're welcome to sign up. 

12 We also recently launched a new 

13 initiative for trying to provide more conservation 

14 buffers on organic acres. The Farm Service Agency 

15 manages the Conservation Reserve Program. 

16 They've set a target for 20,000 acres to be in 

17 buffers on organic farms. These buffers can plant 

18 trees or shrubs. They cost share the 

19 implementation. There are initiatives for 

20 pollinator habitat and wildlife habitat. We're 

21 excited about this. I think it's a great example 

22 of creative use of our existing programs and our 
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1 existing authorities, but targeted toward 

2 supporting the organic sector. 

3 We've also seen a lot of progress in our 

4 Risk Management and Disaster Assistance Programs. 

5 So I won't go through this in depth, but just to 

6 say when I came to USDA in 2010, we actually didn't 

7 have any crop insurance programs that were 

8 specifically targeted to the organic sector. We 

9 now have three different flavors of crop insurance 

10 that cover several dozen crops, and most recently 

11 we announced an initiative where those who have a 

12 contract to get premium prices during the 

13 transition years to organic can now get a crop 

14 insurance product that reflects those premium 

15 prices. All of these tools are really important 

16 to make sure that organic producers have the tools 

17 that they need where if a disaster does hit, they're 

18 made whole at prices that reflect what they would 

19 expect on the organic market.

20 We're also working very hard to expand 

21 our Non-insured Disaster Assistance Program in a 

22 similar direction. NAP picks up where crop 
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1 insurance leaves off, and the Farm Service Agency 

2 has allowed the program to establish separate 

3 prices for those who are getting a premium by 

4 selling direct to the market or by selling on the 

5 organic market. So it is a challenging area just 

6 because the data are hard to get here, but the FSA 

7 team is dedicated to providing solutions to those 

8 sectors. 

9 So moving a little bit to data and 

10 analysis. We've had a lot of developments and 

11 continue to develop more products in this area as 

12 well. Both last year and this year the National 

13 Agricultural Statistics Service conducted organic 

14 producer surveys. For those of you who are 

15 familiar with any surveys or ag censuses, this is 

16 the first time that we have ever had two years of 

17 consecutive data on the organic sector. And I 

18 can't underscore enough how important that is to 

19 be able to understand what is happening in the 

20 organic marketplace and then develop programs that 

21 are appropriately tailored to it. 

22 NASS has also underway with the organic 
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1 certifier survey right now collecting crop acreage 

2 numbers and livestock head numbers. I know that 

3 the producer survey will be published in September. 

4 We don't have a date yet for the certifier survey, 

5 but that should be coming out soon. And for anyone 

6 who works with farmers, please encourage them to 

7 fill out the survey. A high response rate is 

8 incredibly important.

9 So why is this important? How does 

10 this help us? What I've really seen is that we now 

11 have the data to tell the story that we've always 

12 assumed to be true that we can now support with 

13 numbers on the importance of the organic sector.

14 So from the agriculture census some of 

15 the points I always hit are that we're now able to 

16 conclusively say organic farmers are more likely 

17 to be beginning, are more likely to be new to the 

18 farm. They are definitely younger on average than 

19 other farmers and they're more likely to 

20 participate in direct-to-market sales. So those 

21 link up with a lot of other interests that folks 

22 have around USDA and generally in the agricultural 
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1 policy world.

2 We've also been able through economic 

3 analyses to determine that organic producers are 

4 less likely to work off the farm, which I think is 

5 a huge success story for the sector and, in 

6 particular with an analysis we had coming out of 

7 our Economic Research Service, determined that the 

8 profit of organic row crops -- corn, wheat and soy 

9 in this case -- is in fact higher than what it is 

10 in conventional. So we've got good stories in 

11 terms of bringing the next generation back to the 

12 farm and providing a stable farm income for the 

13 future.

14 We're also working to support research. 

15 We know how important it is to have appropriate 

16 technology and on-farm research solutions for 

17 organic producers. So we are working with our 

18 research granting agencies to incorporate language 

19 on organic agriculture, in some of our more 

20 traditional research programs making sure that our 

21 requests for applications make it clear that 

22 proposals on organic agriculture are welcome 
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1 there. And we are continuing to incorporate the 

2 research priorities that are passed by the National 

3 Organic Standards Board into our core organic 

4 research programs, so that they're explicitly 

5 called out in our requests for applications there.

6 Lastly, I want to touch quickly on our 

7 training and outreach efforts, which are a big 

8 focus of what we do with the Organic Working Group. 

9 We recently had some great tools come 

10 out of an external partner through one of our grants 

11 to the University of Minnesota, where we have some 

12 new tools looking at how to transition to organic 

13 agriculture. So for those who haven't seen these, 

14 there's a business planner with a companion set of 

15 farm profiles. Everything is available on 

16 eOrganic. This is the result of a either four or 

17 five-year grant focusing on helping farmers make 

18 that leap from conventional to certified organic 

19 production. 

20 And lastly, I always have to highlight 

21 our accomplishments with our organic literacy 

22 initiative. This is something that we rolled out 
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1 in 2012 and updated just last year where we focused 

2 on internal education at the USDA, making sure that 

3 all of our staff understood the fundamentals of 

4 organic agriculture. I'm proud to say we've 

5 reached over 30,000 people both around the country 

6 and the world through this, and it continues to be 

7 a great way for us to centralize all of our 

8 resources and really showcase what it is that we're 

9 talking about with organic and to get the word out 

10 very quickly and easily to all of our staff.

11 So again, I know that was quite a bit 

12 of information, but I am here both today and always 

13 as a resource. And please do think of me as such. 

14 I always say I can only do my job if I hear from 

15 you and know what the needs are of the community. 

16 So my email is up there. Again the web site that 

17 Elanor mentioned of our organic portal, and I'm 

18 always happy to take questions. Thank you.

19 (Applause.)

20 CHAIR FAVRE: Do we have any questions 

21 from the Board for Betsy? 

22 (No response.)
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1 CHAIR FAVRE: Great. Thank you very 

2 much. Before we proceed, I'd like to introduce a 

3 couple of other NOP staff members that are hiding 

4 back behind this pillar over here. Not 

5 intentional, I assure you. 

6 Dr. Paul Lewis is the head of the 

7 Standards Division and Dr. Lisa Brines is the 

8 national list manager.

9 If you guys will wave to the audience?

10 Okay. Thanks.

11 And a quick couple of housekeeping 

12 items before we go to the NOP's update. The first 

13 thing is we operate on a combination of Robert's 

14 Rules of Order and tradition here, and with the 

15 objective to create an open environment for 

16 discussion. And we have a very packed agenda 

17 today. I'm going to ask that we all do our best 

18 to stay on track, which we're already not on track.

19 (Laughter.)

20 CHAIR FAVRE: And then we'll also be 

21 doing our morning breaks and ask everybody to 

22 return promptly from lunch. 
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1 And next I'd like to have Lisa de Lima 

2 bring us the Secretary's report. 

3 MEMBER DE LIMA: So at this time I'd 

4 like to ask the Board if they have any changes or 

5 corrections to the meeting summary of our fall 

6 meeting in Stowe, Vermont.

7 (No response.)

8 MEMBER DE LIMA: Hearing none, we 

9 accept that summary as official record.

10 CHAIR FAVRE: Thank you, Lisa.

11 Okay. Now I'd like to turn it over to 

12 Deputy Administrator Miles McEvoy. 

13 Thank you, Miles.

14 MR. McEVOY: Okay. So I'm going to 

15 talk a lot about things that are happening at the 

16 National Organic Program, both past, present and 

17 future. 

18 First of all, National Organic Program, 

19 our mission is to ensure the integrity of USDA 

20 organic products in the United States and 

21 throughout the world, so this is a global program. 

22 So we ensure that all products that are so labeled 
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1 or represented as organic in the United States meet 

2 our standards. So that means that we're not only 

3 overseeing the certifiers operating in this 

4 country, but doing that for the certifiers 

5 operating in other countries as well. The 

6 equivalency arrangements, making sure that they 

7 are effectively implemented. 

8 Our vision, organic integrity from farm 

9 to table. Consumers trust the organic label, so 

10 it's not just at the farm level. We have to make 

11 sure that organic standards are maintained at each 

12 step in the production and distribution and 

13 handling aspects, so that when consumers see that 

14 USDA organic label in the marketplace they can be 

15 assured it meets those standards. So we are a 

16 regulatory program implementing the Organic Foods 

17 Production Act and the USDA organic regulations. 

18 So just briefly, we have a number of 

19 different responsibilities: developing and 

20 maintaining the organic standards, accrediting and 

21 overseeing third party organic certifying agents. 

22 They're the ones that do the actual reviewing, 
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1 inspecting and approving of organic producers and 

2 handlers. 

3 We implement and maintain 

4 international organic trade arrangements. We 

5 investigate complaints of violations. For 

6 instance, uncertified farmers selling food as 

7 organic or selling conventional food products as 

8 organic. 

9 And of course we support the work of the 

10 National Organic Standards Board in very -- simply 

11 there's around 80 accredited certifying agents 

12 that work worldwide, over 31,000 certified organic 

13 operations. You have to also keep in mind that of 

14 those certified organic operations, many of the 

15 ones in foreign countries are grower groups that 

16 can consist of hundreds or thousands of farmers 

17 involved in one certified operation. In 2014, $39 

18 billion in U.S. organic sales. So this is a huge 

19 part of American agriculture and very important 

20 that there is this oversight to ensure that 

21 integrity.

22 So in general, we have five areas that 
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1 we focus on in our Strategic Plan. First and 

2 foremost, protecting organic integrity, market 

3 access. And when we talk about market access, it's 

4 not just in terms of international market access, 

5 but for that local and regional access, making sure 

6 that farmers have the tools that they need to obtain 

7 certification and get into the organic 

8 marketplace. 

9 Clear standards are critical to have 

10 standards that are enforceable, so we continually 

11 work on improving the standards, clarifying the 

12 standards and working with the National Organic

13 Standards Board on that.

14 Building technology that advances 

15 organic integrity. That's about the Organic 

16 INTEGRITY Database, making sure that we're using 

17 technology to improve the oversight and audit 

18 trails of organic product. 

19 And then people and process. Making 

20 sure that we have the staff that are trained and 

21 motivated to do the work and that our processes of 

22 doing the work are effective and efficient to best 
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1 utilize the funds that are appropriated for the 

2 program.

3 So a little bit on -- a little more 

4 details on protecting organic integrity. A lot of 

5 you have probably seen this slide before, but we 

6 think of 10 specific points of organic integrity. 

7 Clear enforceable standards. If the 

8 standards are clear, then it's easier for producers 

9 and handlers to comply with those standards, if 

10 they understand them. 

11 Communicating about the standards. If 

12 there's any changes to the standards so that people 

13 don't get caught in not knowing that something has 

14 changed.

15 Transparency. Having that input 

16 through the National Organic Standards Board and 

17 in any of our rulemaking or guidance development, 

18 that -- having a transparent process, public input.

19 Certification. The core business 

20 process of the organic sector. We're involved 

21 with reviewing applications, Organic System Plans, 

22 quality inspections, unannounced inspections. 
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1 All the work that certifiers do to make sure that 

2 it's thorough and complete when they're doing that 

3 work.

4 Complaints. That there's an effective 

5 complaint process so that when people see things 

6 that they feel are out of compliance there's an 

7 effective way to file those complaints. 

8 Penalties for violations that are 

9 appropriate for the type of penalty that has 

10 occurred. Many of the violations are correctable 

11 violations, but when they are more serious, then 

12 there are civil penalties and even more severe 

13 penalties for violating the organic standards.

14 Market surveillance so that there's 

15 oversight in the marketplace. This is one area 

16 that we haven't done a lot of work in. We do have 

17 a project starting this year to look at a couple 

18 of commodities in terms of surveillance testing of 

19 those products for pesticide residues, but that's 

20 one area that certainly needs more development in 

21 the National Organic Program.

22 Unannounced inspections. That's now a 
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1 regular part of how certifiers do their work. 

2 They're doing -- five percent of the operations on 

3 an annual basis are inspected on an unannounced 

4 basis. Periodic residue testing is now a 

5 requirement that certifiers are testing at least 

6 five percent of the operations that they certify 

7 on an annual basis.

8 And then concept of continual 

9 improvement, that there's always looking at your 

10 systems through an isotype of lens of auditing 

11 yourselves, internal/external audits, identifying 

12 areas to improve how we can do a better job in the 

13 certification, in the accreditation and the 

14 enforcement arena.

15 So a little bit of data on compliance 

16 and enforcement. This shows fiscal year 2015 in 

17 terms of the totals in the first quarter of 2015, 

18 or actually two quarters of 2015. So half of 2015. 

19 So in terms of incoming complaints we had over 500 

20 complaints last year. This year we received a 

21 little under 200, so a little bit less in terms of 

22 what's coming in this year from last year. 
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1 Completed complaints last year, 390; 175 have 

2 already been completed this year so far, so it looks 

3 like we may get close to the same numbers as last 

4 year in terms of completed complaints. 

5 But one of the things that's a little 

6 bit troubling about the numbers is that the number 

7 of complaints coming in exceeds the number that are 

8 being completed. So we have work to do to catch 

9 up to the incoming complaints.

10 In terms of types of actions we have 

11 taken on the complaints. Cease and desist orders, 

12 36 last year; 14 so far this year. Notice of 

13 warning, 121 last year, 54 this year. Civil 

14 penalties last year eight, five already this year. 

15 There were 1.8 million in civil penalties levied 

16 last year; $946,000 in civil penalties this year.

17 So some of the other things that we're 

18 doing to get more information about what we are 

19 doing in compliance and enforcement is posting our 

20 enforcement documents. So it highlights the 

21 enforcement actions that we have taken. We want 

22 to do this to increase transparency so that 
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1 operations know there are serious consequences for 

2 violating the organic standards. Enforcement 

3 records involve both certified and uncertified 

4 operations that have violated the organic 

5 standards. 

6 So the documents that have been posted 

7 so far are 6 settlements that we've finalized this 

8 year, 3 Agricultural Marketing Service 

9 administrator decisions that were finalized this 

10 year, 25 ALJ decisions and orders from 2004 through 

11 2016; so that's over a long period of time, and a 

12 link to all judicial officer decisions and orders 

13 since 2004. So this is our first step at getting 

14 this information posted and we plan to post both 

15 new and historical documents as we move forward.

16 Some notable enforcement actions that 

17 we've taken in the last few months. Earlier in 

18 April Yorgo, which is a hummus manufacturer in New 

19 England, they agreed to pay a $340,000 civil 

20 penalty and a three-year suspension for sale of 

21 products as organic without certification. This 

22 was a case where the operation had violated the 
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1 standard, they signed a settlement agreement, they 

2 violated the settlement agreement and the end in 

3 this case is a $340,000 civil penalty and a 

4 three-year suspension.

5 The other significant case is Saul 

6 Farms, which was handled by the Department of 

7 Justice. March 30th Bernard Saul pleaded guilty 

8 to wire fraud and money laundering. So this is an 

9 example of when we get to more serious violations 

10 of criminal activity. We don't have that 

11 authority within the National Organic Program. 

12 That is handled by the Office of the Inspector 

13 General or the Department of Justice. So we worked 

14 closely with them as they worked on this case. 

15 That's for the sale of conventional alfalfa seed 

16 as organic. So Idaho State Department of 

17 Agriculture also worked very closely with the USDA 

18 Office of the Inspector General on this 

19 investigation.

20 Freedom of Information Act is one of the 

21 very important activities that we're responsible 

22 for. Since 1967 the Freedom of Information Act has 
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1 provided the public the right to request access to 

2 records from any federal agency. Federal agencies 

3 are required to disclose any information requested 

4 under FOIA unless it falls under one of nine 

5 exemptions which protect interests such as 

6 personal privacy, national security and law 

7 enforcement. So for instance, we do not -- ongoing 

8 investigations, those fall under one of those nine 

9 exemptions.

10 FOIA also requires agencies to 

11 proactively post online certain categories of 

12 information, including frequently requested 

13 records. So that's part of our job of trying to 

14 get more information out through the AMS Reading 

15 Room so there's more information available.

16 Congress, the President and the Supreme 

17 Court have all recognized that FOIA is a vital part 

18 of our democracy. President Obama and the 

19 Department of Justice have directed agencies to 

20 apply a presumption of openness in responding to 

21 FOIA requests and AMS works in a spirit of 

22 cooperation with all FOIA requesters.
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1 So FOIA requests are a processed with 

2 20 days, so that's a very tight time frame, about 

3 a month. That's 20 business days for us to respond 

4 to those FOIA requests. All NOP staff are 

5 responsible for identifying the response of 

6 records in a FOIA request. Records must be 

7 reviewed that are identified to ensure that they 

8 are responsive records and to redact any 

9 information that falls under those nine FOIA 

10 exemptions. 

11 Some FOIA requests are very 

12 straightforward and others -- or many actually 

13 involve hundreds or even thousands of pages and 

14 years of records. So this is a very large job for 

15 the National Organic Program to provide these 

16 records under FOIA. Currently we have two staff 

17 members that are dedicated to FOIA and additional 

18 staff support as needed to address these FOIA 

19 requests.

20 Okay. Moving on to the National 

21 Organic Standards Board. The NOSB is a federal 

22 advisory committee. It assists and advises USDA. 
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1 It has a charter with established mission and 

2 duties, a designated federal officer, 

3 subcommittees and chair, and opportunity for 

4 public participation. These are all governed by 

5 the Federal Advisory Committee Act. 

6 There's a charter that under the 

7 Federal Advisory Committee Act that is in effect 

8 for two years. We're in the process of renewing 

9 that charter so that the NOSB can continue to 

10 operate. We plan to have the renewed charter 

11 posted very soon since the existing charter expires 

12 on May 8th, I believe. 

13 Call for nominations. So we have six 

14 new wonderful board members at this meeting. For 

15 next year we'll have an additional five new board 

16 members. So there's an open call for nominations, 

17 open until June 3rd for one organic producer, one 

18 individual with expertise in environmental 

19 protection and resource conservation, one 

20 scientist, one handler or processor and one 

21 representative of a public interest or consumer 

22 interest group. 
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1 So please think about applying to be on 

2 the National Organic Standards Board, or if you 

3 know folks that are interested in organic policy 

4 or the organic sector, please encourage them to 

5 apply for these positions. The written 

6 nominations must include a cover letter, résumé and 

7 required form, but please encourage people to 

8 apply. It's really quite an honor and I think most 

9 of the board members most of the time have a really 

10 great experience. And there are flyers on the 

11 table for more information.

12 A summary of NOSB recommendations. So 

13 the Board has been in operation for more than 20 

14 years now. In terms of practice standards, those 

15 are the non-National List standards. There's been 

16 178 recommendations. A hundred and forty-nine of 

17 those have been addressed and 24 are in process. 

18 For instance, aquaculture and animal welfare are 

19 in process. We actually have quite a few of the 

20 outstanding recommendations that are in process in 

21 terms of us addressing. 

22 There are five outstanding 
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1 recommendations that we're not currently working 

2 on. That includes expiration dates on 

3 certificates, which would create an annual 

4 certificate rather than the certificates that now 

5 do not expire. Inspector qualifications. We 

6 have some work that's been done on inspector 

7 qualifications, but more to come on that. Retail 

8 compliance and certification. We haven't 

9 addressed that one yet. Mushrooms, which is an old 

10 NOSB recommendation from 2002. We did some work 

11 on that a few years ago, but we're not currently 

12 working on that. And then a recent GMO prevention 

13 strategy guidance. So the good news is is that 

14 there's many of these other recommendations that 

15 are in the process of being addressed.

16 In terms of the National List and 

17 sunset. On a National List there's been 280 

18 recommendations; 254 of those have been addressed. 

19 Most of the ones that have not been addressed are 

20 very recent and those are in process. We have a 

21 docket working its way through the system for 21 

22 substances. Sunset, 129 reviews have been 
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1 completed. There is an outstanding issue of 

2 sodium nitrate that we did discuss at the National 

3 Organic Coalition meeting yesterday.

4 Hydroponics. 1995, NOSB recommended 

5 that hydroponic production in soilless media to be 

6 labeled organically produced shall be allowed if 

7 all provisions of OFPA have been met. 2005, NOP 

8 confirmed that hydroponic operations may be 

9 certified organic if produced in compliance with 

10 the regulations. 2010, NOSB stated that a 

11 recommendation that USDA shouldn't allow organic 

12 crops to be produced hydroponic methods. And 

13 2015, we established the Hydroponic/Aquaponic Task 

14 Force. So you'll hear from two members of that 

15 task force later this morning.

16 So that task force has been set up to 

17 report on the compatibility of 

18 hydroponic/aquaponic systems and the Organic Foods 

19 Production Act and USDA organic regulations and 

20 provide a report to NOSB that we hope to have early 

21 this summer that looks at current hydroponic and 

22 aquaponic production methods and whether these 
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1 practices align with OFPA and the USDA organic 

2 regulations. 

3 We've done some work on surveys in terms 

4 of how many of these organic hydroponic operations 

5 are there out there. In 2010 we did a survey of 

6 certifiers. We did not define what hydroponics 

7 was in that particular survey and the results that 

8 we received in 2010 may have included hydroponic, 

9 aquaponic and container-based production systems 

10 because there's a continuum between soil-based and 

11 hydroponic systems, and some container-based 

12 systems may have been considered hydroponic-based 

13 systems in the 2010 survey. And at that point no 

14 certification of aeroponics was reported. 

15 So recently we did a survey of 

16 certifiers and we defined what hydroponic systems 

17 are. As you can see there, we also define what 

18 container-based production systems are and there 

19 was no reported certification of aeroponic systems 

20 in this survey. 

21 The numbers are here. In the 2010 

22 survey eight certifiers were certifying hydroponic 
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1 operations and there were 39 certified hydroponic 

2 operations reported. But again, remember that 

3 these were -- it wasn't defined, so they may -- some 

4 of those 39 may have included container-based 

5 systems. 

6 In the 2016 survey 17 certifiers 

7 reported certifying hydroponic and/or aquaponic 

8 operations, 30 certified organic hydroponic 

9 operations, 22 aquaponic operations, 69 certified 

10 container-based operations. And the crops being 

11 produced are quite broad: herbs, greens, tomatoes, 

12 peppers and other mixed vegetables, pea shoots, 

13 microgreens, watercress, berries and edible 

14 flowers. 

15 And then where this is occurring is all 

16 over the place. So California, Mexico, the 

17 Netherlands, North Carolina, Virginia. So all 

18 over the country there are examples of certified 

19 organic hydroponic or aquaponic operations. 

20 So I see some people taking pictures. 

21 These slides will be posted online hopefully later 

22 today so that you can get the numbers.
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1 Okay. Moving onto the Organic 

2 INTEGRITY Database that Administrator Starmer 

3 talked about. We're very excited about this 

4 database. We continue to make improvements to the 

5 database. It's much better than the Excel 

6 spreadsheet that we had last year. I mean, that 

7 had a lot of information, but this is something that 

8 is maintained and kept up much more up to date by 

9 the certifiers. They have the way of providing 

10 information on a more timely basis.

11 The funding for this was provided by the 

12 2014 Farm Bill. It's separate funding from the 

13 National Organic Program. It's a $5 million pot

14 of money that we have available until 2018. We've 

15 used about half of those resources, so we still have 

16 some significant resources to make improvements to 

17 the INTEGRITY Database.

18 In the first release that came out in 

19 the fall there's a lot of different features. I'm 

20 not an IT person, so I don't know if I can explain 

21 all these things, but there's a certifier account 

22 management. There's a way for certifiers to talk 
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1 to this database in different ways. They can send 

2 in Excel sheets. There's some kind of portal which 

3 exchanges data and information. We do provide 

4 more information fields for the certifiers to fill 

5 in so they can provide more data. 

6 We have new product list and 

7 classifications, so this is really important to 

8 standardize the terms so you can find things, that 

9 there's not a lot of misspelled words. But a lot 

10 of this really depends on the work of the certifiers 

11 on that data quality, making sure that they're 

12 using similar terms and taxonomy. 

13 And then we have better search 

14 capability for getting information or requesting 

15 information from the database. And there are 

16 monthly data reports that will be expanded. So 

17 this is what it looks like. It's probably a little 

18 small for those of you in the back, but there's the 

19 list of the certifier, the name of operation, all 

20 the different crops that they have. And this will 

21 continue to be improved over the coming year and 

22 next year.
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1 So our planned enhancements to this 

2 include advanced search enhancements, search by 

3 operation status so you can determine when they 

4 were -- how long they've been certified, improved 

5 product level search capacity, exact word 

6 searches, the certifier profile. So there will be 

7 a feature to find a certifier if you're looking for 

8 certain attributes for a certifier in Mississippi 

9 or in Bolivia. You can have those kinds of 

10 resources. 

11 Complete flat file data export from 

12 search results. The IT people explained to this 

13 to me. They say it's really important and the 

14 certifiers would love this, but I'm not sure I 

15 exactly understand what that means. But 

16 supposedly it's a really good thing.

17 Operation certificate module. So 

18 that's what we plan to release at the end of the 

19 year, or at the end of the fiscal year, is the 

20 ability or certifiers to issue a federalized 

21 certificate from the database. One of the 

22 problems in terms of enforcement and oversight is 
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1 that of those 80 accredited certifiers they each 

2 have their own certificate. So as we work with 

3 other federal agencies and foreign governments 

4 it's very difficult, because all these 

5 certificates look different and they don't have the 

6 same format. 

7 So we are really -- want to move to a 

8 one form certificate, that all certifiers use the 

9 same certificate rather than have these 

10 individualized certificates because that will make 

11 it easier for our partners in APHIS for checking 

12 imports or foreign governments to be able to 

13 actually see that a certificate is a valid 

14 certificate. We're also looking at electronic 

15 certificates as we move into the future. We're 

16 working very closely with certifiers to improve 

17 data quality and encourage frequent data uploads. 

18 Okay. Sound and Sensible. We have a 

19 number of new education and outreach tools. As 

20 Elanor Starmer said, this has been an issue for the 

21 last few years. The whole concept is to make 

22 certification affordable, accessible and 
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1 attainable.

2 There were 14 projects awarded to 13 

3 organizations all over the country, a whole bunch 

4 of different types of tools that are available to 

5 certifiers and organizations that are doing 

6 outreach to the agricultural community. So some 

7 things are for getting information out about what 

8 is organic. Others are about the actual specifics 

9 about how to be successful in producing organic 

10 crops. 

11 So some of the examples are an 

12 interactive video that helps candidate organic 

13 farmers choose their own adventure. So this one 

14 is my favorite where you -- it's a video that has 

15 two different farmers and they -- they're both 

16 curious about organic. One's a direct-market 

17 farmer, one's a wholesale grower and they do their 

18 own little exploration of what is organic, how do 

19 I get certified, how complicated is it? We call 

20 it "The Road". It's really, really well done. 

21 There's also a number of short topic by 

22 topic video clips. Florida Organic Growers has 
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1 done a number of these little video clips that are 

2 quite good on a whole bunch of different topics, 

3 so encourage people to take a look at that. There 

4 are record keeping case studies for four successful 

5 record keeping models. That was a project done by 

6 Oregon Tilth. And then a train the trainer guide 

7 that walks through how to conduct a farm work that 

8 WSDA did. So this is just a short example of some 

9 of those resources that are available through these 

10 Sound and Sensible projects.

11 There were four separate launches in 

12 sort of four different buckets of concepts in the 

13 suite of projects. The first one was the organic 

14 value proposition, Why Go Organic? So if you have 

15 folks that you're trying to show them information 

16 about organic and why it's such a valuable 

17 production method, that's what's in those 

18 products. How To Resources was our second launch. 

19 Third launch was around outreach and education. 

20 And then our fourth was resources for 

21 Spanish-speaking farmers and farm workers and 

22 people working in Latin America. We have a lot of 
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1 the agricultural sector is Spanish-speaking, so 

2 this has been very useful for those folks.

3 Okay. Now moving to organic 

4 standards. So over the last few months we've put 

5 out two new final guidance documents, one on 

6 substances used in post-harvest handling and one 

7 on natural resources and biodiversity 

8 conservation.

9 So the final guidance on post-harvest 

10 handling clarifies whether a substance is 

11 acceptable for use in post-harvest handling. The 

12 challenge has been on post-harvest handling is that 

13 some of the materials on the National List are under 

14 the Crop List under 601 and some are on the 

15 Processing List under 605. And post-harvest 

16 handling can be conducted either on farm or in a 

17 handling facility. So that's been other questions 

18 that we've had as well. And facility pest control 

19 can also be on-farm and also at handling 

20 facilities.

21 So we clarify that the substances that 

22 can be used are non-synthetic substances that are 
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1 allowed from crop production and are not restricted 

2 on 205.602, synthetic substances that are listed 

3 in 205.601 that are specific for post-harvest use. 

4 So there are a few substances on 601 that are

5 specifically listed for post-harvest use. Also 

6 substances listed on 605, which is basically the 

7 Handling List. According to those restrictions 

8 those are also relevant to be used on post-harvest 

9 handling. And any inert ingredients that are used 

10 in any pest-control substances must be allowed in 

11 205.601(m) or meet one of the other conditions. 

12 For instance, a non-synthetic inert ingredient 

13 would be allowed unless it was specifically 

14 prohibited.

15 In terms of facility pest management 

16 non-synthetic and synthetic substances that are 

17 listed in those various sections are allowed. EPA 

18 registered pesticide use in facilities must be 

19 registered for that use. Inerts must be either 

20 non-synthetic or be allowed on 601(m), 603(e) or 

21 605. And preventative practices apply to all 

22 handling facilities whether on or off-farm. 
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1 So final guidance. Post-harvest handling 

2 puts all that information in one place. Very 

3 useful for both farmers and handlers that are doing 

4 that post-harvest handling and certifiers.

5 Natural resources and biodiversity. 

6 This addresses a few different NOSB 

7 recommendations on biodiversity. So this is a 

8 final guidance. Draft guidance came out a year or 

9 so ago. 205.200 requires operations to maintain 

10 or improve the natural resources of the operation 

11 including soil and water quality. This guidance 

12 was developed in collaboration with USDA's Natural 

13 Resource Conservation Service. It provides 

14 examples of production practices that support 

15 these conservation principles and makes that 

16 tie-in between NRCS and USDA organic regulations, 

17 between what organic farmers are doing and those 

18 conservation support programs at NRCS much more 

19 linked.

20 It also states what the 

21 responsibilities are of organic operations, that 

22 their Organic System Plan must address 
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1 biodiversity and that operations that participate 

2 with NRCS can use that part of their plan for their 

3 Organic System Plan. Split operations can use 

4 non-certified land for some of the conservation 

5 efforts. And some examples -- I guess I don't have 

6 examples there. 

7 Okay. So responsibility of certifiers 

8 and inspectors. They need to verify that the 

9 Organic System Plan has those biodiversity 

10 practices included. Inspectors must be qualified 

11 to assess compliance with those very important 

12 parts of the regulations, that operations must 

13 maintain or improve soil and water quality. And 

14 then Appendix A of this guidance offers a number 

15 of best practice examples. For instance, planting 

16 diverse species and controlling livestock access 

17 to biologically sensitive areas. So this is a 

18 whole list of those types of practices that are in 

19 this final guidance.

20 So under development for final guidance 

21 we have classification of materials. That is 

22 really -- I've been talking about this for a long 
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1 time, but it really is close to coming out as final 

2 guidance. Also final guidance for materials for 

3 organic crop production will be coming out in the 

4 next -- we'll say this summer. And then we 

5 have a number of different draft guidance -- boy, 

6 this is coming out strange here -- a number of 

7 different draft guidance documents that should be 

8 published relatively soon. Treated Lumber should 

9 be coming out. Calculation of Organic 

10 Ingredients, which is an NOSB recommendation that 

11 Jean Richardson really cares about. But I -- you 

12 all care about, but I've heard a lot from her about 

13 that particular draft guidance. 

14 Livestock materials, materials for 

15 organic livestock production will be coming out. 

16 Pesticide spray drift. We have draft guidance on 

17 that. So look for that this summer. And then some 

18 new instructions or updates to instructions on 

19 materials review and private label certification. 

20 So there's a lot of things that are under 

21 development that we're hoping to get out before the 

22 end of the administration.
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1 In terms of final rule, Origin of 

2 Livestock will be coming out. And then for 

3 proposed rule we have aquaculture, pet food, 

4 apiculture. All those are way -- really far along 

5 in the clearance process, so you should see those 

6 relatively soon. 

7 And we have a new initiative to put a 

8 proposed rule out on import certificates. Import 

9 certificates are required under our equivalency 

10 arrangements with the European Union and Korea, 

11 Japan and Switzerland. We require affidavits for 

12 Canada. But we're looking at a proposal to have 

13 all imports be accompanied by a transaction import 

14 certificate. We feel that this will help with 

15 oversight and identifying the audit trail of 

16 imported organic products coming into the U.S. 

17 We're hoping to get that out this summer and 

18 actually finalizing that later this year.

19 Organic Livestock and Poultry 

20 Practices was just published a few weeks ago. The 

21 background for where this came from is quite 

22 extensive. First of all, the Organic Food 
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1 Production Act of 1990 talked about the organic 

2 livestock area. Livestock practices were to be 

3 developed with the input of the National Organic 

4 Standards Board and notice and comment rulemaking. 

5 The preamble to the NOP final rule in 2000, further 

6 collaboration between the National Organic 

7 Standards Board and NOP for specie-specific 

8 standards. So it was always considered that there 

9 would be more specificity in this livestock sector. 

10 2010, we had an OIG audit that 

11 recommended to AMS to develop and issue guidance 

12 regarding outdoor access for livestock because 

13 they identified inconsistent practices by 

14 certifiers. Nine recommendations from the NOSB 

15 between 1994 and 2011. And we have implemented the 

16 Access to Pasture Rule in 2010, so really the 

17 non-poultry side, most of that was, at least the 

18 ruminant side was addressed in the Access to 

19 Pasture Rule. So we look at it as sort of 

20 completing the suite of organic livestock 

21 standards making it much more specific for 

22 mammalian and avian species.
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1 So this shows the very different types 

2 of systems that are currently certified organic. 

3 Upper right is a porch-like system that provides 

4 outdoor access through a screened in porch. And 

5 the lower left shows more of a pasture-based system 

6 where you have hundreds of birds outside on 

7 vegetation. So because of this difference in 

8 standards, the wide divergence of practices of what 

9 outdoor access is, the NOSB has made the 

10 recommendations that the porch-like systems in the 

11 upper right should not be considered outdoors. 

12 And so we have a proposed rule.

13 Looking forward to everyone's comments 

14 on this so we can make the final rule even better. 

15 Comment period is open until June 13th.

16 So, yes, we published it on April 13th. 

17 Sixty day comment period. There's also a webinar 

18 that we conducted and the slides and the recording 

19 of that webinar are available on the AMS web site 

20 for more information about the specific proposed --

21 the provisions in the proposed rule.

22 Okay. So and I'll end there with just 
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1 one thing here. So this is a picture of where I'm 

2 from in Washington state. It's now an organic 

3 orchard by Lake Chelan. You can see the 

4 pesticide -- keep out because of pesticide spray 

5 upper right. A farm worker picking a load of 

6 apples lower left. And a couple of kids in the 

7 lower right. 

8 So changing landscapes. Small is 

9 beautiful; we all learned this in school, and big 

10 things make big differences. Organic can be proud 

11 of both. Organic, small scale, sustainable 

12 farming, bringing ecological methods to 

13 small-scale productions, supporting economic 

14 vitality and growth to local communities. Organic 

15 wholesale production, bringing incredible biology 

16 and production systems, soil diversity, compost 

17 love, biological pest control, making a difference 

18 on the landscape, reducing pesticides exposure for 

19 farmer and farm workers. 

20 For those of us who have worked in 

21 production agriculture, in conventional 

22 production agriculture, we know the difference 
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1 that organic makes. No longer living under the 

2 trees in fear of toxic sprays for ourselves or our 

3 children. 

4 When I was a young man I worked in 

5 conventional orchards. There were only four 

6 organic orchards in the whole state of Washington. 

7 Everything else was chemical agriculture. I lived 

8 amongst the trees. We camped in condobiniums, 

9 living spaces made out of apple bins. It was a 

10 grand life. Music, work, food and love during the 

11 fall harvest. 

12 Two of my sons lived in the orchards, 

13 were raised in the orchards during that time. As 

14 a young father it was a very happy, but also a scary 

15 time. Happy to be able to be with our kids every 

16 day, have them with you as you're working in the 

17 fields. It was also scary for the pesticides all 

18 around. Those that have already been applied, 

19 those that were applied while we were picking. 

20 So now, there's no longer just four 

21 small little organic orchards in Washington State. 

22 Ten percent of Washington apples are organic and 
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1 many non-organic orchards use organic methods for 

2 pest control. Thousands of farm workers and their 

3 families, thousands of farmers are not exposed to 

4 these dangerous chemicals. That is my motivation 

5 for this work that I do, keeping farmers, farm 

6 workers and farm families in a healthy environment 

7 or a healthier environment in life.

8 So don't let the perfect be the enemy 

9 of the good. Let's all move forward together. 

10 There is so much good we are all doing to heal the 

11 Earth and create a sustainable future for 

12 ourselves, our children and our grandchildren. So 

13 thank you very much.

14 (Applause.)

15 CHAIR FAVRE: Harriet, go ahead.

16 MEMBER BEHAR: Hi, Miles. I wondered 

17 if you have any plans to put any of the information 

18 about organic for incoming producers into the Hmong 

19 language, either doing some voice-over on the 

20 videos or something written, because we do have a 

21 lot of Hmong producers, at least in my region and 

22 I know around the country that are interested in 
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1 organic and we have very limited resources for 

2 them.

3 MR. McEVOY: Yes, I know there are a lot 

4 of Hmong farmers and farm workers in different 

5 parts of the country. We don't have any current 

6 plans for doing that, but that would be something 

7 to look into if we had resources for that.

8 CHAIR FAVRE: Any other questions for 

9 Miles? Francis?

10 MEMBER THICKE: Miles, some of the 

11 dairy farmers are concerned about some of the 

12 animal welfare standards. There seems to be some 

13 unintended effects in there, I think. And that 

14 will outlaw most of the housing for dairy farms, 

15 organic dairy farms for the winter.

16 But anyway, they're requesting a 30-day 

17 extension. Is that going to be possible for 

18 comments to July 13th?

19 MR. McEVOY: We've received some 

20 requests for extensions and we're taking a look at 

21 that to see whether or not that would be granted 

22 or not. Would encourage people to take a look at 
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1 the webinar for clarifications on some of those 

2 issues. So, but we are looking at those requests 

3 to extend the comment period.

4 CHAIR FAVRE: Any other questions for 

5 Miles?

6 (No response.)

7 CHAIR FAVRE: Okay. Thank you, Miles. 

8 Okay. Next up I'd like to just kind of give you 

9 an overview of what we've been doing on the NOSB. 

10 I'd just like to state that we've got 15 volunteer 

11 members of this Board up here who have been working 

12 really hard to advance the work in the organic 

13 community and we've been tackling some pretty big 

14 issues facing us these days.

15 We have just added three additional 

16 items to our work agenda. In CACS we're going to 

17 be discussing the in-field evaluation of organic 

18 inspectors from recent documents that came out from 

19 the NOP. In Crops we're going to be looking at 

20 strengthening and clarifying the requirements for 

21 the use of organic seed. And we will also be 

22 looking through Materials Subcommittee a five-year 
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1 report to the Secretary on GMOs. And the full work 

2 agenda will be presented at the fall meeting in St. 

3 Louis, which will be in November this year.

4 We did a webinar this past Tuesday, 

5 19th, which I think was very well-received. We had 

6 around 32 public commenters that participated in 

7 the webinar, and at one point we had as many as 93 

8 people on the call or webinar. And it was three 

9 full hours of public comment and questions from the 

10 Board. 

11 I personally am delighted to have this 

12 as an opportunity and a vehicle for public comment. 

13 I think it increases our chances for those of us 

14 that cannot participate in an in-house 

15 face-to-face meeting to call in. I think that that 

16 particularly offers some great opportunities for 

17 farmers who cannot take the time away from their 

18 farms or bear the expense to come to a meeting, even 

19 a regional meeting sometimes. So I'm very happy.

20 And while we still wrestle with a few 

21 technical challenges from time to time, I think the 

22 NOP staff did an excellent job making all that work. 
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1 And I'm sure we'll continue to refine that process 

2 as we move forward.

3 So this week, as we often do, we have 

4 a very, very packed agenda. Although it's nothing 

5 compared to the agenda that my predecessor Dr. Jean 

6 Richardson presided over in Stowe, Vermont, it's 

7 still a pretty hefty list. Over the 

8 next three days we're going to be hearing from an 

9 expert panel on rapidly changing state of emergent 

10 technologies in bioengineering and their impact on 

11 organic agriculture. We'll be hearing from two 

12 members of the Hydroponics Task Force who will 

13 present their perspectives on the work of that 

14 group. That group will probably have their report 

15 done. I believe it's targeted for June of this 

16 year. And that report will be more formally 

17 presented at the meeting in the fall. 

18 We'll also be discussing this week the 

19 next steps and the critical tasks of preserving 

20 organic seed purity and addressing excluded 

21 methods. We'll be voting on some comprehensive 

22 changes to the Policy and Procedures Manual 
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1 including new sections on increasing the 

2 opportunity for that public participation through 

3 the use of technology like webinars and providing 

4 some -- it also provides some clarification on 

5 procedures such as the presentation of minority 

6 opinions. 

7 The Policy Development Subcommittee is 

8 also going to be bringing forward a discussion 

9 document for the reorganization of the review of 

10 sunset materials so that future boards are not 

11 faced with that daunting task of around 200 

12 materials that we dealt with in Stowe. Those of 

13 you that were in the audience there, I'm sure you 

14 can appreciate not only how difficult it was for 

15 you to review and provide comments on that, but for 

16 the Board to provide comprehensive and in-depth 

17 reviews of those materials. And Jean had t-shirts 

18 made up for us at that meeting that said, "I 

19 Survived 2017 Sunset." And I'm not sure we all did 

20 actually survive. 

21 (Laughter.)

22 CHAIR FAVRE: I think a few of us still 
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1 have a little bit of PTSD from it. But hopefully 

2 we're not going to be faced with that daunting task 

3 again.

4 Livestock Subcommittee is presenting a 

5 couple of proposals at this meeting to change the 

6 withholding periods for two parasiticides and two 

7 medicinal treatments which could have some 

8 significant impact on the organic livestock and 

9 fiber producers in this country. 

10 Handling Subcommittee will be bringing 

11 forth a discussion document on the recommendations 

12 for listing nutrient, vitamin and minerals, which 

13 has been problematic for us. And we'll be voting 

14 on a proposal to address the review of the ancillary 

15 substances and handling materials. 

16 Crops will be presenting a discussion 

17 document on the prohibition of MPEs. 

18 And CACS will be giving us an update on 

19 the assessment of organic soil conservation 

20 practices. 

21 All of this is in addition to the more 

22 routine work of the Board, and that's the review 
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1 of sunset materials and the new materials petition 

2 for inclusion on the National List.

3 So hopefully that's given you a little 

4 bit of a sense on what's going on with us. We'll 

5 be working this summer on the research priorities 

6 that we'll be presenting at the fall meeting. 

7 Betsy Rakola, who spoke earlier, referred to our 

8 work on that. We've had some conversations with 

9 the Organic Working Group over the last couple of 

10 years refining that process. 

11 The Research Priorities Framework 

12 document has been a big help with that, but now 

13 we're getting some feedback on the researcher's end 

14 on how we might make that process for them more 

15 useful and more relevant including finding ways to 

16 package it in a way that's more palatable and easier 

17 for understanding for the research funders, which 

18 is obviously critical in order to make all this 

19 happen. 

20 So I would again like to -- before we 

21 go to the National List update, I would just like 

22 to thank you all again for being here. We've got 
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1 a lengthy public comment session, both this 

2 afternoon and into tomorrow. And with that, I'd 

3 like to turn it over to Dr. Brines.

4 DR. BRINES: Good morning, everyone. 

5 My name is Lisa Brines. I'm the National List 

6 manager in the Standards Division of the National 

7 Organic Program, and I'm just giving a brief update 

8 today on some outstanding petitions and technical 

9 reports. And this presentation will be posted on 

10 the NOP web site later this week, for those taking 

11 notes.

12 Okay. So at this meeting there are 

13 seven petition materials on the agenda, as well as 

14 over a dozen substances that will be considered 

15 under the sunset 2018 process. As a reminder, this 

16 is just the first of two meetings for the sunset 

17 2018 materials, so there will be public comment, 

18 discussion at this meeting, but the votes for the 

19 sunset 2018 materials won't occur until the fall 

20 NOSB meeting.

21 In terms of the criteria that you as the 

22 Board will be using to evaluate materials for 
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1 consideration on or off the National List the 

2 criteria are provided for in the Organic Foods 

3 Production Act of 1990. These criteria are the 

4 basis by which we've established the petition 

5 guidelines, the questions in the technical 

6 evaluation reports, as well as the NOSB review 

7 document. So all of those documents in concert 

8 evaluate the materials against those criteria.

9 There are different criteria that apply 

10 for crop and livestock production materials versus 

11 those that are petitioned or considered for use in 

12 organic handling, and the additional criteria for 

13 synthetic processing aids and adjuvants for 

14 handling uses are at Section 205.600(b) of the 

15 standards.

16 In terms of outstanding petitions that 

17 are the agenda for this meeting, the Crops 

18 Subcommittee will be considering a petition for --

19 to amend the -- I guess add an annotation for ash 

20 for manure burning at Section 205.602 of the 

21 National List. And the Committee will be 

22 considering the addition of three materials to 
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1 Section 205.601 of the National List. Those 

2 include squid and squid byproducts, hypochlorous 

3 acid and soy wax. And in support of those reviews 

4 two new technical reports were developed, one for 

5 squid and squid byproducts and one for hypochlorous 

6 acid. And those technical reports as well as all 

7 four of those petitions are on the NOP web site.

8 In terms of what's coming up next there 

9 are several petitions that are currently 

10 outstanding for the Crops Subcommittee that are not 

11 on the agenda for this week's meeting. Those 

12 include aluminum sulfate, fatty alcohols, which 

13 have been petitioned as a growth regulator, 

14 1-Methylcyclopropene, or 1-MCP, and as well as two 

15 recent petitions for chelating agents, which 

16 include ammonium citrate and ammonium glycinate. 

17 All of those petitions are posted on the NOP web 

18 site. There are two technical reports available, 

19 one for fatty -- or in development, I'm sorry. One 

20 for fatty alcohols and one for aluminum sulfate.

21 In addition, since our last public 

22 meeting the Crops Subcommittee did receive a 
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1 petition for calcium chloride, which is posted on 

2 the NOP web site. The Committee had decided at 

3 that time that that petition did not provide 

4 additional new information since the last review 

5 of calcium chloride, since the last petition. So 

6 because that petition didn't contain any new 

7 information, the Crops Subcommittee determined 

8 that it was ineligible for review by the NOSB. We 

9 do have for clarity have that full petition posted 

10 on our web site.

11 For Livestock Committees the Livestock 

12 Committee will also be looking at hypochlorous acid 

13 at this meeting. Again, that technical report is 

14 available and posted. 

15 In terms of what's coming up next for 

16 the Livestock Subcommittee, there are three 

17 petitions that are currently under review for use 

18 as poultry litter amendments. Those include 

19 acid-activated bentonite, aluminum sulfate and 

20 sodium bisulfate. Each of those did have a new 

21 technical report that was developed and all three 

22 of those technical reports are now available on the 
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1 National Organic Program web site.

2 In addition, a new petition for sulfur 

3 was submitted since our last meeting. The 

4 Livestock Subcommittee has requested a technical 

5 report to assist in the review of that substance. 

6 That's currently in development and when it's 

7 finalized it will be posted on the web site.

8 The 10 aquaculture petitions also fall under the 

9 scope of Livestock Subcommittee as well.

10 In terms of handling petitions, at this 

11 meeting the Handling Subcommittee will be 

12 considering the petitions of sodium lactate and 

13 potassium lactate, as well as oat beta-glucan, 

14 hypochlorous acid and sodium dodecylbenzene 

15 sulfonate, or SDBS. Technical reports were 

16 developed in support of the reviews for both 

17 hypochlorous acid and the two lactate salts.

18 Coming up next for the Handling 

19 Subcommittee there's a petition for chlorine 

20 dioxide gas which is currently under review; I 

21 think it's under revision, and a petition for oat 

22 protein concentrate, which is currently under 
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1 review.

2 In terms of other technical reports 

3 that are in development, some of these came as a 

4 result of actions and deliberation at the last 

5 Board meeting. There's currently in development 

6 a technical report for marine plants and algae, 

7 which covers several materials that are on the 

8 National List. There is a technical report in 

9 development for Bisphenol A as a packaging use for 

10 handling, one for xanthan gum in support of a 

11 possible reclassification decision --

12 classification that was brought up at the last 

13 meeting. 

14 In support of the review of peracetic 

15 acid, it's a crops material that's under review for 

16 sunset, since we were updating the crops report, 

17 we also had the resources available this time to 

18 update the livestock and handling reports. So 

19 they're not currently under consideration for 

20 actions by the Livestock or Handling Committees, 

21 but we do have a new report available for peracetic 

22 acid for handling use and one that should be posted 
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1 soon for peracetic acid for livestock use.

2 In addition, there is a new report 

3 available for phosphates for handling, and that 

4 covers several phosphate materials that are 

5 currently on the National List for use in handling 

6 organic products.

7 Just a quick note about technical 

8 report contractors. There have been some 

9 questions about who works on technical reports in 

10 support of the work of the Board. Currently we 

11 have three external and one internal contracting 

12 groups that work on technical reports for the 

13 program. That includes the AMS Agricultural 

14 Analytics Division, ICF International, the Organic 

15 Materials Review Institute and the Pesticide 

16 Research Institute. 

17 For those that do have comments on the 

18 technical reports, certainly we would encourage 

19 those comments to be submitted through the public 

20 comment process. So that can be done prior to the 

21 NOSB meetings through regulations.gov.

22 In terms of voting procedures for 
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1 petitions that we'll have at this week's meeting, 

2 for petitioned substances the NOSB will typically 

3 take votes on two different motions. The first 

4 motion will be a classification motion for 

5 materials that have not been previously 

6 classified. So that might include either a 

7 synthetic or non-synthetic determination or an 

8 agricultural or non-agricultural determination 

9 for some handling substances. 

10 The second motion will be a motion to 

11 either list, remove or amend the substance as 

12 proposed. For each of those actions in order to 

13 pass a two-thirds majority of the Board will be 

14 needed. So for the Board with 15 members, that 

15 means 10 votes to pass either of those motions.

16 For sunset 2018 there are two sunset 

17 dates that apply to these materials, so any of them 

18 that are on the docket for this week's meeting 

19 either expire May 29th or November 3rd, depending 

20 on when they were last added or renewed to the 

21 National List, but we're considering them as a 

22 group just for convenience. So again, they'll be 
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1 considered at this meeting and again at the Fall 

2 2016 meeting. But any voting on those materials 

3 won't occur until the fall meeting.

4 All of the materials, both sunset 2018 

5 and those that are up for subsequent sunset 

6 reviews, those specific dates at which their sunset 

7 are available in the NOP Program Handbook as 

8 document No. NOP 5611. So that is posted on our 

9 web site. If you have difficulty finding it, 

10 certainly let me know.

11 In terms of technical reports that are 

12 available for those sunset 2018 materials, we were 

13 able to meet all of the Board's requests for 

14 technical reports for those materials this year. 

15 Those include new reports for peracetic acid to 

16 address the crop uses, several handling reports, 

17 some of which were limited in scope and included 

18 carrageenan, cellulose, glucono delta-lactone and 

19 potassium hydroxide.

20 Also since our last meeting you may have 

21 noticed that we have published an updated petition 

22 process for the National List. The purpose of this 
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1 work was to implement two NOSB recommendations from 

2 your April 2014 meeting to update the National List 

3 petition process. 

4 One change is that there's a new 

5 document in the Program Handbook that gives the 

6 procedures for petitioning to the National List. 

7 It is document number NOP 3011. And that new 

8 process became effective on March 11th.

9 In terms of what changes happened as a 

10 result of that publication, it did implement the 

11 Board's recommendation to eliminate the 

12 possibility for petitioners to submit confidential 

13 business information. So it's no longer part of 

14 the petition process to have both CBI and 

15 CBI-deleted versions of petitions submitted. 

16 It also requires that petitioners 

17 indicate the category for a substance for certain 

18 uses in organic production. It clarified 

19 procedures for certain types of petitions such as 

20 annotation changes. Some of those changes include 

21 simplified procedures for certain types of 

22 changes. It also addressed common questions about 
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1 the petition process to clarify the role of the 

2 National Organic Program, the role of the Board and 

3 what criteria are used to evaluate petitions.

4 And that's all I have for today, unless 

5 there are questions. Thanks.

6 CHAIR FAVRE: Any questions for Dr. 

7 Brines?

8 (No response.)

9 CHAIR FAVRE: Thank you very much. 

10 Okay. I want to mark this historic 

11 event in that we are actually nine minutes ahead 

12 of schedule.

13 (Laughter.)

14 (Applause.)

15 CHAIR FAVRE: It won't last.

16 We are actually scheduled to take a 

17 break now. And so, I would like us to go ahead. 

18 In the interest of doing our best to stay on 

19 schedule, let's be back promptly at 11:15. Thank 

20 you.

21 (Whereupon, the above-entitled matter 

22 went off the record at 10:51 a.m. and resumed at 
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1 11:17 a.m.)

2 CHAIR FAVRE: Okay, folks, let's get 

3 started back. Let's not lose all the perfect 

4 timing we had. If everybody will take their seats

5 as quickly as possible. Folks, if you're out there 

6 in the pre-meeting area, if you'll let the people 

7 know that we're getting started back and have them 

8 come in and take their seats, please.

9 Okay, we're going to start our session 

10 after the break with a Hydroponics Task Force 

11 update. That's going to be a couple of members 

12 from the task force giving us some information on 

13 the work they're doing, and I'm going to turn it 

14 over to the NOSB liaison to that task force, Zea 

15 Sonnabend.

16 MEMBER SONNABEND: Thank you, Tracy. 

17 As chair of the Crops Committee and liaison to the 

18 task force, I'm pleased to be able to introduce this 

19 little session which will be about not exactly 

20 progress, but it will be a frame outline of some 

21 of the issues that they're working on in order to 

22 create their report, which will be coming to us at 
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1 the next NOSB meeting or before the next NOSB 

2 meeting so we can take it up on our agenda for then.

3 The current status of this is that, 

4 Miles mentioned this a bit in his report this 

5 morning, the USDA regulations do not prohibit 

6 hydroponics, in their minds. And certification to 

7 the USDA organic standards is currently allowed if 

8 the certifier can demonstrate that it complies with 

9 the standards. There are conflicting NOSB 

10 recommendations about this. A 1995 

11 recommendation: hydroponic production in soilless 

12 media labeled organic would be allowed if the 

13 provisions of OFPA are met. In the 2010 

14 recommendation, growing media shall contain 

15 sufficient organic matter capable of supporting 

16 natural and diverse soil ecology. For this 

17 reason, hydroponic and aeroponic systems are 

18 prohibited.

19 So the task force was formed to 

20 reconcile some of these conflicting positions over 

21 time. The composition contains individuals that

22 represent soil-based systems and hydroponic 
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1 systems and aquaponic community, with an emphasis 

2 of technical expertise in both sets of areas. The 

3 objectives are to describe the hydroponic and 

4 aquaponic systems in use and their practices, of 

5 which there are very many. And I will say also the 

6 line is quite blurred between what is hydroponic 

7 and what is known as container-based growing and 

8 how that interfaces with noncontainer growing or 

9 soil systems.

10 They are to examine how hydroponic and 

11 aquaponic methods align or conflict with OFPA and 

12 the USDA organic regulations. And then it says 

13 explore alternatives, but I would say it's more 

14 explore options of what type of standards we would 

15 have to propose to have only the most appropriate 

16 of those systems in use and not the ones that would 

17 be inappropriate with the organic standards, or to 

18 propose what could happen if we did not allow 

19 hydroponics in the end but perhaps have a separate 

20 rule or a separate approach to the systems.

21 So with that, I'm going to let our 

22 presenters tell us a little bit about their work. 
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1 Thank you. 

2 First, we have Stacy Tollefson. Dr. 

3 Tollefson has a Ph.D. and over seven years of 

4 experience with commercial style hydroponic and 

5 aquaponic systems and has further expertise in 

6 biosystem engineering, controlled environment 

7 agriculture and pest management. She's currently 

8 an adjunct lecturer in the Department of 

9 Agricultural and Biosystems Engineering and a 

10 research specialist for the Controlled Environment 

11 Agriculture Center at University of Arizona.

12 Dr. Tollefson's work at the Center's 

13 5,000 square foot teaching greenhouse currently 

14 focuses on IPM techniques, recirculating nutrient 

15 solution systems and transitioning hydroponic 

16 systems to organic production. Dr. Tollefson has 

17 experience managing a commercial aquaponics farm 

18 and consulting for hydroponic greenhouse growers 

19 wishing to transition.

20 Thank you. Dr. Tollefson.

21 DR. TOLLEFSON: Hi. Thank you. I 

22 guess as an overview, our committee has split into 
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1 two different groups, one that's looking at the 

2 emerging technologies that are hydroponic-based, 

3 but aligned with the organic standards. And the 

4 other committee was to look at the 2010 

5 recommendations to provide feedback on that and 

6 clarifications. But it kind of became two 

7 separate positions, if you will. We have the one 

8 group that is for the organic hydroponics and 

9 aquaponics and the one group that wants to keep 

10 everything soil-based. So just to give a 

11 perspective, we're kind of split in our views of 

12 what the regulations say.

13 Okay, so definition-wise, there was a 

14 definition in the 2010 recommendation for 

15 hydroponics. We adjusted it to be a little more 

16 specific. Our definition of hydroponics is the 

17 growing of plants in a mineral solution with or 

18 without an inert growing media to provide 

19 mechanical support. 

20 We agree with the 2010 recommendations 

21 that these kinds of systems should be prohibited, 

22 the reasons being that they use unapproved inputs, 
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1 insufficient carbon and biology in these systems, 

2 and there's no nutrient cycling. Everything is in 

3 a plant-available form, and microbiology is not 

4 necessarily required in these systems.

5 The emerging technologies that were not 

6 addressed in the 2010 recommendations are systems 

7 which we call bioponic. And these we define as a 

8 contained and controlled growing system in which 

9 plants derive nutrients from organic substances 

10 which are in the water and/or the growing media 

11 which are released by biological activity of 

12 microorganisms that are throughout the system. 

13 These modified hydroponic systems use the same 

14 organic inputs, processes, and principles as field 

15 growers use.

16 In looking at the alignment with the 

17 organic principles and the regulations, all inputs 

18 are compliant with the National List including the 

19 media that's used. There is sufficient organic 

20 matter added to the system to support microbial 

21 diversity. The biology is added to the system and 

22 maintained in the system so that we do have nutrient 
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1 cycling in those systems. And also, natural 

2 resources of the farm site are conserved so that 

3 the soil and water quality are not degraded. And 

4 any excess fertilizer that does come out of the 

5 system is captured and repurposed, and it doesn't 

6 go out to the farm site.

7 One example is aquaponics, and this is 

8 a system of aquaculture in which the waste produced 

9 from farmed fish or other aquatic animals supplies 

10 the nutrients for plants, and then the plants are 

11 grown hydroponically, which actually cleans the 

12 water, and that clean water is input back in the 

13 system for the fish. So it's a completely clearly 

14 closed system, except for evaporation.

15 Our example 2 is bioponic tomato 

16 production. In this case, tomatoes are grown in 

17 a base of organic coconut husk or other organic 

18 material. The crop nutrition is supplied through 

19 solid and liquid plant, animal, and National List 

20 approved minerals. There is biology added to the 

21 system, which is necessary for this system to 

22 actually work and produce a crop. The media is 
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1 either inoculated with a compost tea or some other 

2 microbial product or natural sources. Earthworms 

3 are often added to the media as well.

4 A third example is lettuce, a bioponic 

5 lettuce system in which lettuce is started in a base 

6 of organic material. The crop nutrition is again 

7 supplied through liquid organic fertilizers, which 

8 may be fermented plant materials or compost teas. 

9 And these are typically recirculating systems. 

10 The biology again is added through compost tea. 

11 Many of these systems have biofilters in which 

12 there are active microorganisms in the system to 

13 cycle the nutrients, or there may be other 

14 microbial inoculant products that are added which 

15 are on the National List or the OMNI-approved list.

16 The 2010 recommendations state that 

17 container culture-based growing media which is 

18 typically used in greenhouse systems which 

19 predominantly have compost or compostable plant 

20 material should rightly be considered soil. And 

21 we agree with this. We do also further believe

22 that other bioponic container systems should also 
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1 rightly be included because we do support all 

2 soil-dwelling organisms that you would find in the 

3 soil food web, and they would be within our growing 

4 systems.

5 Bioponic growing systems, because they 

6 are container systems, they maintain the site soil. 

7 So with all of the regulations that state that the 

8 soil must be maintained or improved, we do maintain 

9 the soil on the site. Therefore, there's no need 

10 to perform soil crop rotations or cover cropping. 

11 Our runoff drainage does not contribute to surface 

12 and groundwater contamination since it is 

13 recaptured or repurposed. And that would 

14 definitely have to be something that might need to 

15 be put in a regulation at some point.

16 Our subcommittee came to the conclusion 

17 that the intent of the organic regulations is to 

18 be able to grow foods in a way that provides the 

19 least harm to the earth's soil, water, and 

20 biological communities. And for production 

21 systems to integrate, of course, cultural, 

22 biological, and mechanical processes that foster 
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1 the cycling of resources, promote ecological 

2 balance, and conserve biodiversity. And that 

3 definition of organic production is certainly what 

4 our main idea is for these bioponic systems. We 

5 do that within our growing system. And to grow 

6 foods that are chemical-free and healthy.

7 One thing to consider, of course, is how 

8 the public views organic foods. Numerous studies 

9 have been done on consumer beliefs, and the main 

10 findings that you see is that people associate 

11 organic with chemical-free, healthy and 

12 nutritious, and environmentally friendly. I have 

13 not seen any reports that people associate organic 

14 with grown in the soil in particular. Thank you.

15 CHAIR FAVRE: Thank you. Our next 

16 presenter is John Biernbaum. Dr. Biernbaum is a 

17 Professor of Horticulture at Michigan State 

18 University. Over the past 30 years, he's acquired 

19 extensive academic and practical experience in 

20 greenhouse management, container plant fertility 

21 systems, high tunnel vegetable production, organic 

22 agriculture, and composting.
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1 Dr. Biernbaum was involved in the 

2 development and certification of a year-round 

3 organic teaching farm, a one-year organic farmer 

4 training program, a sustainable and organic 

5 horticulture concentration, and teaches a class, 

6 of course, in organic farming principles and 

7 practices. He has been a member of the Michigan 

8 Organic Farm and Food Alliance Board of Directors 

9 since 2009 and is currently chair of the MOFFA Board 

10 and Education Committee. Thank you

11 DR. BIERNBAUM: Thank you very much for 

12 this opportunity to share, this morning, what we've 

13 been working on. I'd like to just start by 

14 recognizing the other members of our subcommittee. 

15 There's seven of us. Combined, there's over 160 

16 years of experience with organic farming, 

17 education, and certification.

18 I'd also like to recognize the efforts 

19 of USDA in so thoughtfully bringing us together in 

20 a way that's been very productive and constructive, 

21 which doesn't always happen in a situation like 

22 this where you have people with different ideas. 
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1 That it's been a good experience, and I appreciate 

2 all the effort that's gone into making it that kind 

3 of an experience.

4 We've been asked primarily to focus on 

5 the what and the how of how to do these systems, 

6 the aquaponics, the hydroponics, and also 

7 addressing the indoor enclosures. But the first 

8 part of our report, we also, in addition to 

9 addressing the what and the how, are working on 

10 addressing the why of organic agriculture and why 

11 we're doing things. 

12 This particular figure is taken from 

13 the 1940 book, Look to the Land by Lord Northbourne 

14 where he laid out some of the early concerns about 

15 what was happening with agriculture and the soil, 

16 and he also referenced the concerns about 

17 hydroponics then. He, as many others, often point 

18 to the development of water culture systems around 

19 1840 to 1860, 100 years previous, as one of the 

20 reasons why organic agriculture developed in the 

21 ways that it did with this emphasis on feed the soil 

22 and not the plant. 
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1 At that same time, Sir Albert Howard 

2 published An Agricultural Testament where the key 

3 thesis of the story that he was telling of his work 

4 in India was the importance of healthy soils 

5 leading to healthy plants, healthy animals, and 

6 healthy people. This is a slide that I started 

7 using probably 12 years ago as I was learning about 

8 organic agriculture, and I've included it in dozens 

9 of talks and as a way of helping to talk about what 

10 the purpose is and where's the background of 

11 organic.

12 We're not going to get into a real 

13 detailed story of the time line here, but just going 

14 from that 1940, if we fast forward 50 years of 

15 organic certification and 50 certifying agencies 

16 is when we began this process that we're really 

17 looking at more detail of the Organic Food 

18 Production Act starting in 1990 and then the NOP 

19 regulations in 2000 and 2001.

20 So the question is what's going to 

21 happen going forward? This is another key aspect 

22 of what we're discussing in both of our 
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1 subcommittees, the importance of organic matter in 

2 soil biology and also that there's much more to 

3 organic farming than just the soil biology. One 

4 of the concerns that I have based on past 

5 experiences in academia is the risk of taking 

6 something that's very large and integrated and 

7 reducing it or taking some part of it and 

8 emphasizing it. The biology is important as is the 

9 organic matter, but we're learning so much about 

10 the different roles here. 

11 And one of the questions that we need 

12 to consider is is the estimated six to seven billion 

13 organisms that could be in a cupful of healthy soil, 

14 how does that compare to what would be present in 

15 a bioponic, NFT-type system that has compost and 

16 has organic inputs in, but how do those compare? 

17 And I think the answer is going to be we don't know 

18 at this point, but it is something that we can 

19 certainly consider as we go through this process.

20 But the way I've learned organic 

21 farming, even though I started in the greenhouse 

22 and I started with transplants, is I've gone on to 
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1 learn so much more about what happens in the field 

2 and how we manage these soils to have a truly 

3 successful organic system, and that it's much more 

4 than the biological contributions of nutrient 

5 availability and cycling and disease management, 

6 but we also have to really think about the physical 

7 contributions of what's happening in these 

8 systems, particularly now as the NRCS and so many 

9 people are reminding us about, with the climate 

10 change issues and the heavy rainfall and the need 

11 to retain water, how important these physical 

12 contributions are, as well as the chemical 

13 contributions, of building this foundation of 

14 nutrients that will be available over a long period 

15 of time without routine updating or additions.

16 So as we shift from some of the reasons 

17 why we come back to the regulations, and this is 

18 one of the foundational sections of OFPA where 

19 looking at this call for soil fertility, that an 

20 organic plan shall contain provisions designed to 

21 foster soil fertility primarily through the 

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

2 this is in our report what we seek to develop in

3 more detail, just why these principles are there 

4 and what was intended here. And also, this seems 

5 to be one of the key parts that is being interpreted 

6 different ways that needs to be resolved. 

7 This other, production and handling

8 practices: if a production or handling practice is 

9 not prohibited or otherwise restricted under this 

10 chapter, such practice shall be permitted, unless 

11 it is determined that such practices would be 

12 inconsistent with the applicable organic 

13 certification program. And I think that's where 

14 there's some differences of interpretation of 

15 this. Are these systems consistent or not? And 

16 that's what really needs to be resolved.

17 When we look more closely at the organic 

18 regulations, we address a number of the different 

19 sections, but this is one that really stands out 

20 when it comes to soil fertility and nutrient 

21 management and the fact that we're defining these 

22 practices. And there's this emphasis on the must 
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1 here, select and implement tillage and 

2 conservation practices that maintain or improve 

3 the physical, chemical and biological, as I 

4 mentioned previously, condition of the soil and to 

5 minimize soil erosion. And then also that the 

6 producer must manage crop nutrients and soil 

7 fertility through rotations, cover crops and the 

8 applications of plant and animal materials.

9 And there are exceptions. The 

10 different types of systems that have been or are 

11 being identified, and the question is how far do 

12 you go with those exceptions? In our case, we also

13 have an extensive amount of international 

14 regulations that we can look to, and it's going to 

15 be really important that whatever is decided from 

16 this, that how this is going to align with our key 

17 trading partners and their policies, particularly 

18 with Canada, the EU and Mexico. And for the most 

19 part, what we see internationally is requirements 

20 for in-ground production with certain limited 

21 exceptions. 

22 And then there's other information 
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1 that's available where some places the regulations 

2 do include more information about containers. And 

3 Canada has been working on that, and there's some 

4 in the Scandinavian countries. And that can be 

5 addressed by either talking about the size of the 

6 container or the media that's in those containers, 

7 just what are the substrates that are allowed, and 

8 how frequently or infrequently do they need to have 

9 fertility added? And those are some of the things 

10 that are developed in great detail in the report.

11 One other part of the report is looking 

12 closely at the 2010 recommendation and trying to 

13 offer suggestions on how it could be -- the wording 

14 could be chosen and things could be clarified. I 

15 feel very fortunate to be in this position, with 

16 30 years of teaching greenhouse management and 

17 operations and 15 years of learning about organic 

18 farming, to be able to help offer some suggestions 

19 as well as to summarize all the thoughts of the 15 

20 members on the task force, and we're working on 

21 trying to do that so that we can have that available 

22 for the NOSB. 
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1 The original definition of a 

2 greenhouse, in the 2001 recommendation, just 

3 mentioned a structure. It didn't mention what is 

4 essential to a greenhouse, which is a transparent 

5 roof. And because of that, things are being grown 

6 in buildings which would be more correctly called 

7 controlled indoor environments. So we're helping 

8 to identify those things so that we can be more 

9 accurate.

10 Also, with lighting, lighting is 

11 allowed, but how much lighting? Are we going to 

12 allow indoor production with 100 percent lighting 

13 or lighting as supplemental? So there's other 

14 issues about what is the compost and about 

15 rotations also. So lots of things that we're 

16 working hard to share.

17 As we look at trying to make some 

18 conclusions here, again, I can use myself as an 

19 example of starting 15 years ago with my 

20 introduction to organic coming from greenhouses 

21 and from transplants. At that time, there wasn't 

22 a regulation. I had the act to look at, and I 
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1 started asking farmers. And I admit that my 

2 perception of organic was biased because of where 

3 I came from. I didn't really come necessarily from 

4 a farming background. I came from a greenhouse 

5 background. But as I asked more and more questions 

6 and learned about what the expectations were, I 

7 learned how to include compost and other systems 

8 that could make the indoor systems more resilient 

9 and more successful in the long term.

10 So just looking at some pictures, as we 

11 think about this, I'm going to show you just a range 

12 or a continuum of examples that will have to be 

13 chosen or described as how we're going to manage. 

14 In this case, a very simple enclosure with high 

15 tunnels where we're definitely growing in the 

16 ground, and we see a rapid, I think we're finally 

17 getting out of this slow growth and high tunnels 

18 into the rapid growth phase. And again, in part 

19 due to the support of the USDA and the High Tunnel 

20 EQIP program and other things like that, it's going 

21 to really help many, many farmers in both urban and 

22 rural settings. But it's an enclosed system. 
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1 It's not leaching. We have to be careful about how 

2 we manage that fertility. 

3 I think that's -- we can do, as we look 

4 at the potential for more indoor heated production. 

5 This is the Stone Barns, the facility at the Stone 

6 Barns, a center in New York, seeing more in-ground 

7 production with heated greenhouses. There's a 

8 good potential that's going to grow, and we need 

9 to maintain that. 

10 But this is from a greenhouse in Detroit 

11 that is right across from the MGM Grand Casino built 

12 on a parking lot. And this is a soil -- a big box 

13 of soil. And we're going to have to ask, is this 

14 a container? Is this soil? Is this something 

15 that can be certified as organic? And is it 

16 growing in the ground, or is it not growing in the 

17 ground? 

18 And here's a greenhouse that's on the 

19 MSU campus, 20 feet from a dormitory. And this was 

20 built in an area where you couldn't grow in the 

21 ground, and there's 45 cubic yards of compost that 

22 I made there from the food waste that was taken from 
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1 the dormitory a hundred yards away. So this is a 

2 100 percent compost system, and it's been growing 

3 in there for four years with little to no addition 

4 of nutrients. So there's a lot of things that are 

5 possible.

6 On a smaller scale, this idea of bucket 

7 production, or are we going to allow this as 

8 in-compost based media, or this type of bucket 

9 production in a greenhouse where it's more of a 

10 bioponics-type system with frequent inputs? Are 

11 we going to allow large hydroponics production? 

12 This is not an organic system, but this is the 

13 growing greens in Chicago. And we're going to see 

14 more of this type of production. How will it be 

15 managed?

16 And finally, this type of indoor 

17 production that people are talking about with the 

18 100 percent lighting and liquid ways of managing 

19 the fertility. Is this something that we think is 

20 suitable for an organic systems plant?

21 So in conclusion, our committee is 

22 taking more of the position that the hydroponic 
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1 systems cannot meet key requirements for the 

2 organic production, as laid out in OPFA and the USDA 

3 organic regulations and that these systems do not 

4 align with the founding principles of organic 

5 agriculture, which are the sound management of soil 

6 biology, ecology, and overall soil health. 

7 And there will be some options that will 

8 have to be decided. Is there going to be 

9 limitations that are based more on growing what is 

10 in the ground? Is this more common in the EU? Or 

11 will there be organic certification to what is 

12 grown in the ground as well as some type of 

13 definition for containers with restrictions for 

14 enclosures, lighting, and fertility that could 

15 include -- that's a big option there. It could 

16 include many different things as we've shown. 

17 So with that, I think that's the end.

18 MEMBER SONNABEND: Thank you, Dr. 

19 Biernbaum. We do have, I believe, 15 minutes for 

20 questions from the Board, and Tracy, will you be 

21 calling on people or should I? Okay. 

22 Okay, so does the Board have any 
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1 questions for our panelists? Francis. Thank 

2 you.

3 MEMBER THICKE: Dr. Tollefson, can you 

4 tell us more about the nutrient solution you used, 

5 and in particular, nitrogen for a heavy feeder like 

6 tomatoes, how does that work?

7 DR. TOLLEFSON: As I mentioned before, 

8 one of the inputs that is commonly used is compost 

9 tea. And compost teas can use both compost and 

10 added soil amendments that would be on the National 

11 Priorities List that get added to the tea making 

12 process. And with the microbes in that compost tea 

13 making process, it helps with the nutrient cycling 

14 to bring those nutrients into a form that can be 

15 used by the plants. There are also some commercial 

16 liquid products that are fermented plant materials 

17 and animal materials that produce amino acids and 

18 ammonia typically, and you need microbes in the 

19 system to then convert the ammonia to nitrates.

20 MEMBER SONNABEND: Harriet?

21 MEMBER BEHAR: Dr. Tollefson, can you 

22 tell me the percentage -- we know that vibrant, 
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1 biologically active soil is teeming with 

2 biological activity, and you're also saying that 

3 the bioponics has biologic activity. What is the 

4 percentage? Are they equal? Are they -- is it 10 

5 percent of the activity that you might find in soil?

6 DR. TOLLEFSON: I honestly can't tell 

7 you. Unfortunately, this is such an emerging 

8 technology that we don't have the research out 

9 there yet, and that is a real limitation to this. 

10 So there is quite a bit of work that needs to be 

11 done to test for that type of information.

12 MEMBER SONNABEND: A-dae.

13 MEMBER ROMERO-BRIONES: Can you tell 

14 me if their container growing or hydroponic systems 

15 are more popular in different regions of the 

16 country?

17 DR. TOLLEFSON: It's really across the 

18 board, just everywhere, and that's the beauty of 

19 these systems, that they can be used in any region, 

20 whether it's Antarctica, we have a research 

21 indoor-growing facility where you can't bring 

22 fresh vegetables but once a month maybe, where they 
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1 can actually grow and have food. You can use these 

2 on the moon. So these systems can be used 

3 anywhere, and all types of systems are used in all 

4 different areas.

5 MEMBER SONNABEND: Francis.

6 MEMBER THICKE: I've heard that in the 

7 bioponics that frequently ozone is used to keep it 

8 from becoming too biologically active to plug up 

9 the system. Is that true that ozone is used to 

10 modulate that?

11 DR. TOLLEFSON: Yes, that is certainly 

12 an issue, and that's why research is -- that's why 

13 I'm doing research on these types of systems right 

14 now because it is possible that there's too much 

15 microbiology, at least at the beginnings when you 

16 put these nutrients into the system. The 

17 microbes, there are so many microbes, I can't 

18 enumerate them, but there are so many microbes they 

19 do use up quite a bit of oxygen, and that can be 

20 a problem for the plants. So there is a lot of 

21 management and a lot of research that needs to go 

22 into this. However, there are some very 
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1 successful growers that are using these techniques 

2 and have put the research time into it, and that's 

3 why these types of systems are quite proprietary 

4 in their methods and nutrients because they have 

5 spent a lot of money and research to do this.

6 DR. BIERNBAUM: If I could add to that, 

7 one of the -- in trying to learn about these systems 

8 that we've heard some in our committee reports. 

9 But I have one student who works at a greenhouse 

10 that uses this type of a system that's associated 

11 with a hospital near Detroit, and he was pretty much 

12 on his own figuring it out. But he learned what 

13 I heard from the committee is that using these 

14 systems that there could be enough particulate 

15 matter that the roots could be covered with a film 

16 that could lead to then oxygen depletion and 

17 reduction in growth. And that the only way -- the 

18 way that he did and others have done is to then 

19 filter this system and remove a number of the 

20 particulate matter and other things to try to 

21 prevent that biofilm from forming on the roots. 

22 Again, that seems like a fairly specific 
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1 modification that isn't -- that seems a little 

2 contrary to me to what we're trying to accomplish.

3 DR. TOLLEFSON: May I say something on 

4 that note?

5 DR. BIERNBAUM: I hope there's more to 

6 that story.

7 DR. TOLLEFSON: Yes, there are also 

8 ways to adjust the microbiology of the system to 

9 help prevent those things from occurring.

10 MEMBER ROMERO-BRIONES: For the 

11 hydroponic systems in particular, is there waste, 

12 and what is done with the waste?

13 DR. TOLLEFSON: In many of these 

14 systems, they are recirculating, and so there are 

15 no wastes: we reuse any excess solution. In some 

16 cases where you have, like a binding production 

17 system, where you have media in a bucket, there is 

18 some waste solution, and sometimes it is 

19 recirculated as well. Sometimes it is captured 

20 and used on an outdoor crop, but the nutrient levels 

21 would be known beforehand to know that we're 

22 sufficient to meeting the needs of the outdoor crop 
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1 and not polluting our soil and water of the site.

2 MEMBER SONNABEND: Harriet and then 

3 Emily.

4 MEMBER BEHAR: Since we are charged to 

5 also, especially when we're looking at materials, 

6 to review things in a sustainable farming system, 

7 I have some concern about the heavy reliance on 

8 inputs, off-farm inputs. A lot of organic farmers 

9 really seek to produce a lot of their own fertility 

10 on the farm and to move away from purchased inputs 

11 whether they're allowed or not. And this includes 

12 the use of energy because it is in an enclosed 

13 environment for heat, maintenance, and lighting. 

14 So can you speak to how a hydroponic system could 

15 be considered sustainable?

16 DR. TOLLEFSON: Okay, yes. One thing 

17 is that many of these systems do use compost, and 

18 it may not be necessarily from the farm site, but 

19 certainly from a waste-producing locality near 

20 them. As far as sustainability goes, for 

21 instance, the media, even if it's not a compost, 

22 the media can be re-used. 
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1 The inputs, like I said, many times the 

2 inputs are compost teas. So that kind of goes with 

3 that. If they do use commercial product, there 

4 aren't very many commercial products on the market, 

5 but most of those are waste product produced. 

6 There is some carbon footprint in the production 

7 of those products, so I'd agree with that. But all 

8 together, these systems are going to save you 

9 approximately 90 percent of the water inputs that 

10 you're going to use. They will also save on the 

11 nutritional inputs because we know exactly what 

12 those plants need and what they're going to use, 

13 and we can monitor that very closely and adjust our 

14 inputs to be conservative.

15 DR. BIERNBAUM: From the compost 

16 perspective, that's the focus of my current 

17 research, is looking at taking locally-available 

18 resources including food waste, which is a big 

19 issue right now that's being addressed -- how can 

20 we get more of these nutrients back to the farm? 

21 -- and in a local set up that a farm can do on-farm 

22 composting using things like leaves and straw and 
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1 hay together with food scraps and produce a system 

2 that could be a very effective long-term supply of 

3 nutrients in a container-type system.

4 The greenhouse that I showed that's on 

5 campus, as I mentioned, it's been growing for four 

6 years with very little to no inputs other than some 

7 leaf mold type compost with all local materials. 

8 So I think that that's one part, and I think the 

9 water part, we've kind of had that in the 

10 discussion, that if you compare hydroponic or 

11 bioponic type systems to field-flood production, 

12 yes, there's big differences in water. But if we 

13 compare it to other enclosed greenhouse container 

14 systems, my estimates would be that there's not 

15 really that much difference. Actually, after our 

16 meeting in San Diego, I had the class set up a demo 

17 of a bioponic-type system and a compost system, 

18 both in enclosed flats, and looking at how much 

19 water they applied over a three weeks of kale 

20 production, and they were basically the same. 

21 So it's just what are you comparing, and 

22 we definitely want to conserve water, and that's 
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1 one of the advantages of these container systems 

2 is that we can conserve water in a non-leaking type 

3 system.

4 DR. TOLLEFSON: So you're saying with 

5 the compost, that experiment, that was container 

6 to container, correct?

7 DR. BIERNBAUM: Correct.

8 DR. TOLLEFSON: So what my argument 

9 would be that the water in any of those container 

10 systems is going to be, I would say, 75 percent to 

11 90 percent water conservation compared to a field 

12 situation.

13 MEMBER BEHAR: Just to follow-up on 

14 that. I'm just wondering: but the vast majority 

15 of the hydroponic system set are being certified 

16 organic right now, they're not necessarily the 

17 bioponic using compost tea. They are?

18 DR. TOLLEFSON: They are.

19 MEMBER BEHAR: I thought they were 

20 using just like approved -- other approved inputs. 

21 No. Okay.

22 DR. TOLLEFSON: There may be 
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1 situations where everything would be approved 

2 inputs. If not, I don't know why the certifier 

3 would be doing that, but I don't know. But there 

4 may or may not be sufficient biology. It may be 

5 organic sources that are already soluble. And 

6 that is an issue that we are discussing in our 

7 report is the role of the biology. Just because 

8 it's there doesn't mean it's organic. We need to 

9 see some nutrient cycling.

10 MEMBER SONNABEND: Okay, Emily.

11 MEMBER OAKLEY: Just in hearing your 

12 comments, I wanted to speak to one point about water 

13 conservation, simply because I'm a field-based 

14 grower and a lot of my crops provide all of their 

15 water needs through rainfall and never require 

16 irrigation, so I just wanted to put that out there 

17 was a point of comment.

18 But my question was that you spoke or 

19 referenced the biological activity in organic 

20 matter which you just referenced again. Could you 

21 describe that in a bit more detail?

22 DR. TOLLEFSON: I'm sorry, about what?
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1 MEMBER OAKLEY: Could you describe the 

2 biological and organic matter components of a 

3 hydroponic system in more detail, please?

4 DR. TOLLEFSON: Sure. As I said, the 

5 inputs many times are compost teas, and so that 

6 organic matter of the compost is going to be 

7 contributing to the nutrients, the nitrogen and all 

8 the nutrients for the plants.

9 In other situations, we would be adding 

10 some solid amendments perhaps to the media if it's 

11 a media-based system. Those again would be 

12 National List approved and it could be blood meal, 

13 feather meal, kelp, any of those types of products. 

14 On the other hand, in the liquid stream, 

15 you could have some of these fermented plant 

16 products, and then your sources are coming from 

17 that, your nitrogen and everything else.

18 MEMBER SONNABEND: Scott.

19 MEMBER RICE: I was wondering if you 

20 have considered the essentiality of those -- of 

21 crop rotation in those in-ground systems? You 

22 make a distinction on in-ground is more in line with 
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1 the standard, and I'm just wondering if you've 

2 considered the crop rotation, for instance, and 

3 something that is doing explicitly lettuce or some 

4 other crop?

5 DR. BIERNBAUM: We have been 

6 discussing that, and I would say the short answer 

7 is there's just some difference of opinion which 

8 we're trying to capture, but that when I started 

9 working in high tunnels, I was working under the 

10 assumption that we had to do rotations, and we 

11 worked out rotations, so it's clearly possible.

12 There are some economic factors there 

13 in terms of certain crops. Tomatoes and spinach 

14 are potentially higher profitable or more income 

15 per unit of square foot of area compared to some 

16 of the other crops, but I believe it's possible with 

17 a diverse system to do that.

18 We are doing that at the Student Organic 

19 Farm, but I'm not in a business where my life 

20 depends on that, and that's where the other side 

21 of the story comes in is where someone's livelihood 

22 depends on the income from that structure and being 
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1 able to pay for the costs of that structure, both 

2 the construction and maintenance that you've got 

3 to have -- the economics have to work. 

4 So can you do that or not is the question 

5 we've been discussing and trying to come back 

6 around to being able to have a good answer in the 

7 report about the different perspectives of that. 

8 But that is one of the key things that will have 

9 to be decided. So right now, if you look at it, 

10 there's room for the certifiers to make exceptions 

11 for rotation in some of the enclosed -- I think that 

12 needs to be reconsidered.

13 MEMBER SONNABEND: Any other 

14 questions? Carmela? You're right against 

15 reflective mirrors, so it's hard to see your hand.

16 MEMBER BECK: Okay, so Dr. Tollefson, 

17 in your report, I saw you used the word bioponics. 

18 So I was wondering -- and you gave a couple of 

19 examples. I'm wondering if that's an industry 

20 utilized word, if it's a common one and if you could 

21 talk a little bit more about that.

22 And Dr. Biernbaum, you didn't mention 
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1 bioponic in your presentation, and I'm just 

2 wondering if both subcommittees are utilizing the 

3 same definitions in the presentation of materials 

4 or in the final report, you're working from the same 

5 basic definitions.

6 DR. TOLLEFSON: Yes. We were very 

7 conscious of our verbiage. And the whole 

8 committee decided to use the same language. So we 

9 agreed upon a definition of soil. We agreed upon 

10 a definition of bioponics. Bioponics is a 

11 relatively new term. We had some experience with 

12 it, just looking in the literature -- well, not so 

13 much the literature, but online. 

14 Typically, bioponics is a combination 

15 of hydroponics and aquaponics, but it is also a 

16 combination of hydroponics and any 

17 microbial-mediated type of growing system, and 

18 aquaponics being one type. So bioponics basically 

19 means an integration of a hydroponic system which 

20 has organic inputs and that has microbiology that's 

21 cycling the nutrition.

22 DR. BIERNBAUM: I'm not sure if I fully 
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1 understand your question, but there were some 

2 places in my -- what I presented here where we're 

3 referring to hydroponics of old which as Stacy 

4 defined as inorganic-type hydroponics. And then 

5 when I was referring to the types of systems that 

6 they're working on now, I tried to use the word 

7 bioponics, that that's the word that the overall 

8 task force or committee, both committees agreed to 

9 use. That word has been around for a while, but 

10 it's not -- I wouldn't say that it's common usage 

11 yet.

12 MEMBER SONNABEND: Harriet?

13 MEMBER BEHAR: Are either of you aware 

14 of the studies that were done, I think about 12-14 

15 years ago, about there being higher antioxidants 

16 in crops grown in organic fields because the plants 

17 are exposed to some weed pressure, some insect 

18 feeding and that then challenges the immune systems 

19 of the plants which then result in higher 

20 antioxidant? I believe it was done by the American 

21 Chemical Society, and I know that Chuck Benbrook 

22 knows about that. Do either of you know about 
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1 that?

2 DR. BIERNBAUM: Certainly aware of 

3 that, and both the individual studies and then 

4 there have been what they call the meta studies 

5 where they try to look at several things together. 

6 We heard within the last year or two the Stanford 

7 one that came to one set of conclusions that when 

8 people looked at it, they didn't all agree even what 

9 the conclusions were. But then there was one prior 

10 to that where they tried to isolate the studies and 

11 come up with comparisons, and often the challenges 

12 are, the difficulties, is it a good comparison or 

13 not? Are you comparing the system, or did you go 

14 to the grocery store and buy this and that which 

15 probably isn't a good comparison because there are 

16 so many other variables. But overall, my 

17 perception is there are some carefully-done 

18 studies that show some specific differences with 

19 higher antioxidants and phytochemicals say in 

20 organic systems versus other systems. But that's 

21 still something that where more data could be used. 

22 That's looking at the overall system and how does 
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1 that affect the plant and how the plant is growing 

2 and the rate of growth and the amount of nitrogen 

3 fertilization and the amount of water. There are 

4 many factors there that people are considering.

5 DR. TOLLEFSON: One thing is that first 

6 of all, most of the meta-studies say it's not 

7 conclusive, organic versus conventional produce, 

8 no difference in nutritional quality.

9 But one thing I wanted to mention first 

10 of all, conventional and organic hydroponics can 

11 be easily designed to increase antioxidant levels. 

12 And there's much research out there on that. And 

13 typically, there is some research to show we have 

14 higher lycopene levels and antioxidant levels in 

15 an inorganic system.

16 However, when we look at bioponics, 

17 that's an organic system. This is organic input, 

18 so I don't see how -- we don't have the research 

19 out there yet because this is such an early emerging 

20 technology, but I would venture to guess that we 

21 would have the same type of nutritional quality as 

22 a field-grown organic system because it is an 
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1 organic system.

2 DR. BIERNBAUM: That's one of the 

3 things that's really been lacking in that Sir 

4 Albert Howard brought that to the attention in 1940 

5 is that these studies where they look at fertility 

6 is they're really not looking at -- the question 

7 would be, could you grow in these hydroponic or 

8 bioponics systems crop after crop after crop and 

9 select the seed and continue to show that these 

10 plants would be healthy? That's a big if. But it 

11 is really at the foundation of our food and how our 

12 food is healthy is by growing in systems over long 

13 periods of time in closed systems, and there is 

14 concerns about that, that we haven't really done 

15 that type of work, and Sir Albert Howard raised it 

16 a long time ago, and it's something we still haven't 

17 really addressed.

18 MEMBER SONNABEND: Okay, I think we're 

19 out of time. And so I'd like to thank our panelists 

20 very much and we'll be hearing a lot more about this 

21 in the fall, and board members will have ample 

22 opportunity to talk about this within our 
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1 subcommittee once we receive the report. Thank 

2 you.

3 (Applause.)

4 CHAIR FAVRE: Thank you to our 

5 presenters for being with us today and sharing your 

6 perspectives.

7 We're going to start the public comment 

8 portion of the meeting. I'd like to have a couple 

9 of reminders -- we're out of time, sorry.

10 (Laughter.)

11 CHAIR FAVRE: Just a couple of 

12 reminders. We have a very tight agenda, so please 

13 again, be very respectful of the time constraints. 

14 I don't want to, but I will, if I have to, inject 

15 myself and ask you to wrap things up if you have 

16 a tendency to go long. 

17 It's three minutes for public comments. 

18 And Michelle, you want to go over the timer system? 

19 Actually, I might just say the timer blinks green 

20 first, then yellow, and then red. You'll get a 

21 buzz, which you just heard, when the red comes up. 

22 That means you're done. And then we'll have an 
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1 opportunity for board members to ask questions.

2 I will ask all of you to keep it 

3 professional. We're all very passionate here, but 

4 please no personal attacks, and they will not be 

5 tolerated. And just as a reminder to everyone, 

6 please silence your cell phones.

7 We will be taking a break at 12:45 and 

8 we will return promptly after lunch starting back 

9 at 2, so if you're on the agenda to speak, please 

10 make sure you're back here at 2 because I don't want 

11 to have to delay the start of the meeting for the 

12 speakers' schedule, so if you're not back, we may 

13 have to proceed without you.

14 Michelle has -- if you have a 

15 presentation, Michelle has the clicker and is going 

16 to put it up there on the podium.

17 Michelle, do you have any other 

18 messages for public comments?

19 MS. ARSENAULT: No other messages, but 

20 I do want to thank people for all the notes that 

21 you added to your registration when you signed up. 

22 Very helpful for me, and I think I was able
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1 to accommodate everyone's travel schedules and all 

2 that, so I do appreciate that. Thanks.

3 CHAIR FAVRE: Okay, thank you. So 

4 first up for our speaking comments is Dave Chapman, 

5 and we're going to David Miskell on deck.

6 MR. CHAPMAN: Hello. I'm Dave 

7 Chapman. I own Long Wind Farm in Vermont. We grow 

8 organic greenhouse tomatoes. I have the 

9 distinction of being the only full-time farmer on 

10 the Hydroponic Task Force who actually grows in the 

11 ground.

12 I'm presenting a letter today to the 

13 NOSB that was written by seven organic farmers, 

14 three of whom are here today, and the letter is 

15 calling for a moratorium on certifying new 

16 hydroponic production as organic. It also calls 

17 for the NOP regulations banning hydroponics from 

18 organic certification to be created. 

19 This letter is also going to Elanor 

20 Starmer and Secretary Vilsack. It calls for quick 

21 action to create a clear standard that supports the 

22 traditional meaning of organic. It's already been 
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1 six years since the 2010 recommendation, so we hope 

2 that a moratorium will prevent hydroponic organic 

3 from becoming too big to fail as has happened in 

4 the past.

5 The letter was signed by 39 

6 organizations from around the world. Signers 

7 include NOC, all seven of the state NOFA chapters, 

8 MOFGA, OCIA, Center for Food Safety, Beyond 

9 Pesticides, Cornucopia, Organic Consumers 

10 Association, New England Farmers Union, Biodynamic 

11 Association, and Demeter.

12 From Holland, it includes Bionext, 

13 Federal of Organic and Biodynamic Farmers, 

14 Nautilus Organic, plus AIAB from Italy, BOLW from 

15 Germany, CAPE from Canada and Soil Association from 

16 England. And the Italian organization alone 

17 represents 10,000 organic farmers. It was also 

18 signed by 15 former members of the NOSB and 56 other 

19 leading farmers, soil scientists and organic 

20 advocates.

21 The signing organizations speak for 

22 well over 100,000 members, many of them organic 
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1 farmers, many of them just people who care about 

2 organic. Very few of them actually grow 

3 vegetables in a greenhouse. They don't have a 

4 horse in this race. They simply care about 

5 preserving the meaning of organic certification.

6 We're at a crossroad for organic 

7 certification. It's a confusing place. No 

8 matter what happens now, it will be a defining 

9 moment for the organic movement around the world. 

10 Most people have little idea of how enormous the 

11 response will be from the hydroponic community as 

12 the doors to organic certification are opened. 

13 The ensuing flood of hydroponic production will 

14 have enormous consequences in terms of consumer and 

15 farmer trust in and support of the USDA organic 

16 seal.

17 In the end, will our decision enhance 

18 or damage the public trust in the organic label? 

19 Will this decision enhance transparency or will we 

20 have to hide what the new organic means? What 

21 happens when organic means one thing to the USDA 

22 and another thing to the organic community?
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1 We hope that the USDA can have a nice 

2 day.

3 (Laughter.)

4 (Applause.)

5 CHAIR FAVRE: Any questions for Mr. 

6 Chapman? Harriet?

7 MEMBER BEHAR: I'm just curious as a 

8 member of the task force, do you feel like you'll 

9 be able to come up with a recommendation for us at 

10 the end? I mean how are things going in the --

11 internally, I understand there's kind of two sides, 

12 and I'm just wondering how the communications are 

13 going and how we're moving forward.

14 MR. CHAPMAN: The mission to the task 

15 force, as we've been told over and over, is not to 

16 come up with a recommendation, but to provide 

17 information so that you can come up with one. But 

18 you know, clearly the way the task force was 

19 selected, it was not expected that we would come 

20 to consensus, and we will not. There are two 

21 really divergent points of view there. I have come 

22 to respect the other point of view and certainly 
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1 have become friends with some of the people, but 

2 I still don't agree with them at all. 

3 So I think that you will get two roads 

4 described that we might pass with a few possible 

5 clarifications of what this or that would mean.

6 CHAIR FAVRE: Any other questions? 

7 Okay, thank you very much.

8 MR. CHAPMAN: Thank you.

9 CHAIR FAVRE: Next up is David Miskell 

10 with Anais Beddard on deck.

11 MR. MISKELL: I'm David Miskell. I 

12 have an organic -- certified organic greenhouse, 

13 a half-acre in Charlotte, Vermont. I've been 

14 involved with organic farming for 42 years and with 

15 34 of them on my own farm.

16 I have testified throughout this whole 

17 process to the NOSB on the issue of organic 

18 hydroponics right from day one. And it sort of got 

19 left behind a little bit. As all of you know, 

20 farming is over a full-time job. 

21 About three or four years ago, maybe 

22 five years ago, Dave Chapman and I started seeing 
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1 lots of organic certified tomatoes coming from 

2 Mexico. And we kind of questioned, what's 

3 happening here? We did more research and found out 

4 that they were being grown hydroponically and were 

5 being certified as USDA organic.

6 Luckily, I have a neighbor, Jean 

7 Richardson, who I spoke with about that, and she 

8 showed me the 2010 recommendations, and I said 

9 well, how is this happening? Dave and I did more 

10 research and decided that we as farmers needed to 

11 work towards maintaining the organic integrity, 

12 which we have in the past five years.

13 I can be honest to say if it hadn't been 

14 for our push on this issue, this would not be talked 

15 about at all with NOP. 

16 Our call for a moratorium is for a 

17 couple of reasons. One reason is this is 

18 confusing, and I've watched USDA in their process 

19 of making decisions. It's going to take forever 

20 as far as I can see. And it's what Dave said, it's 

21 going to become too big to fail. And this needs 

22 to stop.
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1 The other issue that came back out was 

2 how to certify. Are we going to need professional 

3 certifiers versed in organic hydroponics in order 

4 to be able to certify these places? Right now, VOF 

5 does not certify organic hydroponic. If the rule 

6 comes out to allow organic hydroponics, are all 

7 certification agencies going to have to be forced 

8 to certify this process?

9 Then you go back to organics from the 

10 start, which Dr. Biernbaum talked to them. It was 

11 a revolt against reductionism in the chemical 

12 fertilizer practice of growing. And they were 

13 focused on holistics. And this is the issue, as 

14 I've heard the presentation on the hydroponics. 

15 Thank you. 

16 And I have a petition of names that we 

17 got from 2013 to 2016 supporting the NOS 2010 NOSB.

18 CHAIR FAVRE: Thank you. Any 

19 questions for David Miskell? Thank you. Next up 

20 is Anais Beddard, followed by Tom Beddard on deck.

21 MS. MISKELL: Hi. My name is Anais 

22 Beddard and I'm the second generation at Lady Moon 
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1 Farms. We're the largest organic vegetable grower 

2 east of the Mississippi, but we weren't always this 

3 size. Our farm was founded nearly 30 years ago by 

4 my parents when organic wasn't a buzz word and 

5 farmers markets weren't in every city.

6 They believed in the importance of 

7 biodiversity within the larger ecosystem and 

8 making sure you're putting more into the soil than 

9 what you're taking out. It was a radical approach 

10 back then with little to no support from the

11 established agricultural community or land grant 

12 universities, but they persevered and they put 

13 blood, sweat, and tears to make the company what 

14 it is today.

15 I want a shot at continuing my parents' 

16 legacy. I want to provide healthy food that I know 

17 is grown with real commitment to making our 

18 nation's soils come alive through the judicious use 

19 of cover crops, compost, and crop rotation to name 

20 just a few of the sustainable practices that 

21 organic farmers use every day.

22 As I became entrenched in the 
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1 agriculture industry, I met Dave Chapman and Dee 

2 Dee, and I began to research the soil and organic 

3 movement. Working closely with them, other 

4 farmers, help from the Cornucopia Institute and 

5 many other people, a petition was put forth that 

6 demands that the USDA and NOP accept the 2010 NOSB 

7 recommendation to prohibit soilless hydroponic 

8 vegetable production as certified organic. 

9 Here's that petition. I have it with nearly 1300 

10 signatures that we got in just a few short months 

11 this year. 

12 We ask that you immediately institute 

13 a moratorium on the organic certification of all 

14 new hydroponic acreage until the final rule is 

15 issued.

16 To me, organic was always about the 

17 earth and the greater ecosystem. It never crossed 

18 my mind that a greenhouse without a speck of soil 

19 in it could sell organically. And it shocked me 

20 that we would allow hydroponic produce to be sold 

21 organically when those countries who were the main 

22 producers of such would not.
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1 Where is the reciprocity between 

2 countries? Where is the common sense? 

3 I began talking to people; family, 

4 friends, colleagues, acquaintances, wondering if 

5 they were aware that the bell pepper or tomato they 

6 were eating was hydroponically produced while 

7 still organic. Not surprisingly, most of them had 

8 no clue.

9 When I explained what it was, they were 

10 shocked. As the consumer yearns to learn more 

11 about where their food comes from, will we let them 

12 continue to think the bounty is coming from the 

13 earth, rather than a sterile greenhouse

14 environment? It's not that hydroponics are bad. 

15 As the population grows, when you're eight billion 

16 people, we need new ways to grow food. But is it 

17 organic? I think not.

18 The average age of the farmer in the 

19 U.S. is 60 years old. I'm only 28, nearing 30 as 

20 our farm does, too. What will the next 30 years 

21 look like? I hope Lady Moon Farms continues to 

22 provide healthy, organic food for generations to 
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1 come. But this year has been an eye opener. The 

2 El Niño weather pattern took its toll on our Florida 

3 farms and I saw crops just diminish. 

4 So I'll end quickly, just two more 

5 sentences. It's because of all of these reasons, 

6 organic, soil-based farmers must do all of this, 

7 plus a lot more and it's these reasons and effort 

8 putting into creating a richer, more sustainable 

9 soil that consumers pay a premium for organic 

10 produce.

11 Would consumers pay this higher premium 

12 if they saw the factory hydroponic greenhouses? I 

13 don't think they would, but right now they don't 

14 have the choice. So thank you, and here's the 

15 petition.

16 CHAIR FAVRE: Thank you. Any 

17 questions for Anais? Thank you very much.

18 Next up is Tom Beddard, and then we have 

19 Pete Overgaag on deck.

20 MR. BEDDARD: It is Beddard, but that's 

21 okay, and her name is Anais. Good afternoon, NOSB 

22 board members. My name is Tom Beddard. I along 
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1 with my late wife, Christine, founded Lady Moon 

2 Farms in Selinsgrove, Pennsylvania on a worn out, 

3 rocky, 22-acre farmette that in 1988 had little 

4 potential for making a living. It was, however, 

5 on this very unlikely piece of ground that together 

6 we saw some unknown potential others couldn't see. 

7 And what was it about Chris and I that 

8 allowed us to see something so unlikely? I believe 

9 that it was our firm belief in the fact that soil 

10 is a living organism, one that when cared for 

11 properly teems with life in many, many forms, seen 

12 and unseen. And because of this, even old, worn 

13 out soil could be brought back to life through the 

14 principles of what is commonly known as organic 

15 farming.

16 It is this love of the soil over most 

17 of my life that brings me here today. Lady Moon 

18 Farms is now the proud caretaker of almost 3,000 

19 acres in three states, farming on many different 

20 soils in different climates, and yet this founding 

21 principle of organic farming has never failed us. 

22 For us to be a certified organic farmer begins and 
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1 ends with how we care for the soil. 

2 The soil truly is the soul of organic 

3 farming, and this is a sentiment shared by the vast 

4 majority of certified organic farmers worldwide. 

5 We were the seventh farm to ever be 

6 certified organic in Pennsylvania way back in 1988, 

7 and now almost 30 years later, I am troubled by the 

8 fact that there is a somewhat new but rapidly 

9 expanding production system, a production system 

10 that uses no soil and yet wears the highly coveted 

11 USDA certified organic seal. It troubles me that 

12 the NOSB way back in April of 2010 recommended to 

13 the NOP that hydroponic vegetable operations do not 

14 meet the high standards set forth in OFPA. 

15 I remember clearly, as past president 

16 of the Eastern PA Chapter of OCIA and the founding 

17 president of PCO, all the discussions that the 

18 organic community had with itself over the pros and 

19 cons of the Federal Government creating a certified 

20 organic seal through the USDA. One of the main 

21 benefits was the idea of reciprocity, that what it 

22 meant to be certified organic would be the same all 
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1 over the world. And yet, in 2016, we find 

2 ourselves wondering how the NOP can allow products 

3 grown without soil to be sold in the United States 

4 as certified organic, mostly produced in Canada, 

5 Mexico, and Holland, when these same products 

6 cannot be sold as certified organic in their own 

7 countries.

8 How is this possible? It just makes no sense.

9 Mexico, Canada, Japan, New Zealand and 

10 24 European countries all prohibit hydroponic 

11 vegetable production, yet their producers are able 

12 to export their products to the United States' 

13 organic premium market, hurting the bottom line of 

14 domestic soil-based farmers. It threatens the 

15 integrity of the USDA seal and what it means to be 

16 a certified organic grower in the United States. 

17 And this simply cannot be allowed to stand.

18 In 2010, the NOSB made a clear 

19 recommendation: hydroponic systems should not be 

20 eligible for organic certification. I urge the 

21 NOP to respect that decision and enforce it. As 

22 one of our Founding Fathers once said, "While the 
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1 farmer holds the title to the land, actually, it 

2 belongs to all the people because civilization 

3 itself rests upon the soil." And I can keep going 

4 because the light didn't go off?

5 CHAIR FAVRE: I was going to say, I 

6 don't think our timer got reset for you. Thank 

7 you.

8 MR. BEDDARD: How long was it?

9 CHAIR FAVRE: We appreciate you 

10 self-monitoring.

11 MR. BEDDARD: And I had to cut stuff 

12 out. I was going to go further.

13 CHAIR FAVRE: Do we have any questions 

14 for Tom?

15 MR. BEDDARD: Thank you, and I did want 

16 to say thank you for your volunteer service. 

17 That's something that I don't think people 

18 understand because I've been asked. That's a real 

19 time commitment, and I honor you all for that. 

20 That is truly amazing. Thank you.

21 CHAIR FAVRE: Thank you. That's nice 

22 to hear.
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1 (Applause.)

2 CHAIR FAVRE: Okay, next up is Pete, 

3 and Pete pronounce your last name for me.

4 MR. OVERGAAG: Overgaag.

5 CHAIR FAVRE: Okay, I got that one 

6 right. Good job. And then on deck is Mark Kastel.

7 MR. OVERGAAG: Thank you. I'm with 

8 Hollandia Produce. I'm a third generation 

9 greenhouse grower, growing lettuce and watercress. 

10 Both my grandparents in Holland were greenhouse 

11 growers, as were my parents, who immigrated to the 

12 USA in the 1960s and continued on with greenhouse 

13 growing here. So I grew up in the greenhouse 

14 business. 

15 My dad showed me how to grow cut flowers 

16 when I was ten years old, and he helped me set up 

17 my own small plots of production, which I started 

18 from seed, grew to finish, and then harvested and 

19 sold to the local street corner flower stands. 

20 Our company started with hydroponic 

21 vegetables back in 1986 using conventional 

22 fertilizers at the time. It was very exciting to 
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1 see the efficiency improvements that hydroponics 

2 brought: less labor, more production per acre, 

3 and of course, major water savings. California 

4 had drought periods then as well, just as we do now.

5 About eight years ago after hearing 

6 bits and pieces of info about organic container 

7 growing being possible, we decided we had to figure 

8 this out. We set the goal of learning this process 

9 and then later set the end goal of switching our 

10 entire operation over to organic container 

11 growing. We still have more areas to convert, but 

12 all of our new areas are set up as organic from the 

13 start.

14 This head of lettuce that I have here 

15 was grown organically, not one synthetic input was 

16 used. Everything we use is OMRI-approved. We 

17 have biological activity in the starter growing 

18 media as well as in the water that's circulating 

19 throughout our system.

20 We've always been sustainable growers, 

21 releasing predatory insects even on our 

22 conventional crops, conserving water, recycling 
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1 our waste, et cetera, et cetera. It has always 

2 been in my blood to be sustainable and conservative 

3 with resources. Only use what you need, and save 

4 what you can. For example, I have three types of 

5 solar systems on my home. My electric bill is 

6 about $1.35 per month and my gas bill is about $15 

7 a month. I bring this up because I believe in 

8 sustainable technology, and I am thankful that 

9 these solar systems have been developed so I can 

10 live in a sustainable manner. It just makes sense.

11 Looking back, it would have been quite 

12 a shame if the solar industry had been stifled and 

13 held back by naysayers who insist on things staying 

14 the same and not allowing new methods to be 

15 developed and implemented. I draw this 

16 correlation of what's happening here in the organic 

17 world. We have this great method of producing 

18 organic food that is more sustainable and 

19 economically viable than the old ways. It should 

20 be supported, not stifled. Thank you.

21 CHAIR FAVRE: Thank you. Any 

22 questions for Pete? Thank you very much. We 
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1 appreciate the lettuce.

2 MR. OVERGAAG: I want to answer one 

3 question from earlier. We don't use ozone in our 

4 systems. It's all living. No ozone.

5 CHAIR FAVRE: Thanks. Thank you. 

6 (Applause.)

7 CHAIR FAVRE: Next up is Mark Kastel 

8 and then we've got Patricia Kane on deck.

9 MR. KASTEL: My name is Mark Kastel. I 

10 act as the Cornucopia Institute's senior farm 

11 policy analyst. I'm proud to be here today 

12 representing our approximately 10,000 members 

13 including a sizable percentage of the organic 

14 farmers in the U.S., including many folks who are 

15 here testifying.

16 When you hear some of the industry 

17 denigrating our credibility of Cornucopia, they 

18 are dissing these hard-working farmers, including 

19 many of the agrarian elders and leading voices in 

20 organic agriculture. This industry has morphed 

21 from a farmer-led organization and movement to an 

22 oligarchy. 
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1 My comments today will help connect 

2 some of the dots. We now have the pasture rule. 

3 We have giant CAFOs placing ethical farmers at a 

4 competitive disadvantage. Many are milking 

5 three, even four times a day with 100 percent 

6 confinement for their top producing cows. We have 

7 filed a number of complaints, including against the 

8 WhiteWave/Horizon dairy in Idaho. They've never 

9 been investigated by the USDA based on FOIA 

10 records, but their certifier, QAI, says that 

11 they're in compliance. Case closed.

12 WhiteWave's chief lobbyist sits on the 

13 OTA Board and has been instrumental in the 

14 appointment of current and past NOSB members. 

15 Money speaks loudly in Washington.

16 Mr. Miles McEvoy sent a letter to the 

17 industry five and a half years ago explicitly 

18 saying that organic producers, egg producers "must 

19 provide livestock with an opportunity to exit any 

20 barn or other enclosed structure." Other 

21 structure. That would mean a porch. Five and a 

22 half years later, no enforcement.
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1 Today, in 2016, the vast predominance 

2 of organic corn and soybeans and many other grains 

3 are being imported from countries with a history 

4 of endemic commercial fraud with incredibly weak 

5 oversight by the USDA. And who's minding the 

6 organic materials' chicken coop?

7 Congress explicitly, explicitly 

8 empowered the NOSB to hire their own technical 

9 review scientists. The USDA has always violated 

10 this provision of the law. At one point, the OTA's 

11 scientific arm was doing the TRs. Now one of the 

12 most prolific contractors is the Organic Materials 

13 Review Institute. They earn $2.5 million a year 

14 worth of funding from the industry they are 

15 scrutinizing. Their board includes executives 

16 from General Mills, the Organic Trade Association, 

17 and many other industry interests. 

18 Who are the authors of these reports? 

19 We don't know. It's secret. 

20 We do know that the technical reviews have 

21 conveniently left out many scientific reports that 

22 would be damaging to industry interests. 
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1 Some of the most prominent brands 

2 represented on this Board have the lowest scores 

3 in the Cornucopia and OSB score card. 

4 Cornucopia's radical scoring criterion -- I really 

5 timed this carefully. I have a little bit left. 

6 Just a little bit.

7 CHAIR FAVRE: A little bit.

8 MR. KASTEL: Sure. Thank you, Madam

9 Chair. Our scoring criteria is 100 percent 

10 compatible with the other NGOs, so I'm appealing 

11 now to the NOSB members and the veteran members who 

12 are dedicated to organics and are willing to take 

13 a hard, independent look. Please consider the 

14 comments of Cornucopia scientists and other 

15 nonprofits when making your decisions. Please 

16 table the PPM revision because that is rubber 

17 stamping the changes that the USDA made. You're 

18 now going to bring the PPM into compliance with the 

19 changes they made without the input of this Board. 

20 Thank you very much.

21 CHAIR FAVRE: Thank you. Any 

22 questions for Mark?
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1 Thank you, Mark.

2 MR. KASTEL: Thank you.

3 CHAIR FAVRE: Next up is Patricia Kane, 

4 followed by Christie Badger on deck.

5 MS. KANE: Hello. I'm Patricia Kane. 

6 I'm the coordinator of the Accredited Certifiers 

7 Association, and thank you for the opportunity to 

8 provide comments.

9 My original comments were going to be 

10 a request to the Compliance, Accreditation, and 

11 Certification Committee to take up the discussion 

12 of NOP 2027, the instruction pertaining to 

13 performance evaluations. But now I don't have to 

14 do that. Thank you very much for doing that.

15 The instruction reviews the 

16 requirements for certification agencies relating 

17 to annual personnel performance evaluations. 

18 Included in the instruction document is a section 

19 on field evaluation. This was a new requirement 

20 for certification agencies to conduct an annual 

21 on-site evaluation of all inspectors. ACAs do 

22 support the tool of on-site evaluation of 
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1 inspectors and find it valuable. However, even 

2 without that component of the evaluation, all 

3 inspectors undergo performance evaluation every 

4 year. The formal performance evaluation is in 

5 addition to the evaluation of each inspection 

6 report that is submitted to the agency.

7 There are two main issues with the 

8 instruction document that are extremely 

9 problematic for certification agencies. They are 

10 now required to conduct a field evaluation of each 

11 inspector every year at the expense of the agency, 

12 regardless of the number of inspections conducted 

13 by the inspector for that agency. Even though the 

14 instruction states inspectors should be evaluated 

15 during an on-site inspection by a supervisor or 

16 peer at least annually, the NOP is interpreting the 

17 should as a must, requiring ACAs to conduct the 

18 annual on-site evaluation of inspectors, and if 

19 they are not conducted, noncompliances are issued 

20 to the agency.

21 So in the two years since the 

22 publication of the instruction, certification 
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1 agencies' budgets have increased dramatically. 

2 Many agencies have significantly reduced the 

3 number of inspectors being used, and inspectors are 

4 undergoing multiple evaluations each year if they 

5 work for multiple agencies, consuming a lot of time 

6 and effort.

7 So we've identified just a few issues 

8 that we would like the Board to look at, and one 

9 is a lack of public input on this new requirement; 

10 the NOP interpretation of should as a must in the 

11 issuing of noncompliances; the identification of 

12 the nature of the concerns and problems that NOP 

13 is attempting to correct; why a risk-based approach 

14 to conducting annual field evaluations is not 

15 acceptable; and the lack of specific NOP 

16 requirements, guidance, and instruction for 

17 inspector education and training, despite having 

18 information on that provided by IOIA.

19 We would like to extend our 

20 appreciation to the NOSB for their continued work 

21 you are doing on the difficult topics of excluded 

22 methods, seed purity, and attempting to sort out 
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1 the work of the sunset process. Thank you.

2 CHAIR FAVRE: Thank you for that. I 

3 apologize. We're having some technical 

4 difficulties, I think, with the lighting system, 

5 but Michelle is keeping track over there, and you 

6 were within your time limit. So thank you. 

7 Questions? Yes. Jean?

8 MEMBER RICHARDSON: Pat, I'd just like 

9 to thank you for bringing this issue to the 

10 attention of the NOSB. And also to the NOP for 

11 being so quick to agree that this is an issue that 

12 we need to understand more about in order to ensure 

13 the integrity of organic inspections nationwide. 

14 What would be helpful to the CACS Subcommittee 

15 during the next few months as we review this is we 

16 can't do a survey. We're the NOSB. But anything 

17 that you can provide us in the way of specific data, 

18 facts, that help us to understand what the costs 

19 are in dollars in terms of the budgets, especially 

20 for the larger certifying agencies that they are 

21 then having to put into their budget and to the 

22 degree to which that then becomes sustainable over 
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1 time, if in fact having to do these inspections 

2 every year takes place without flexibility, 

3 although it does appear that there is some 

4 flexibility built into that. 

5 And anything you can provide us also to 

6 suggest alternative methods for ensuring that 

7 indeed we inspectors are inspected in the field on 

8 a regular basis, any kind of proposals that we could 

9 look at to evaluate so that we can provide -- based 

10 on the public comment from you and from other 

11 inspectors, et cetera, so that we can provide the 

12 most useful information as quickly as possible back 

13 to the NOP in regards 2027. Thank you.

14 MS. KANE: Thanks, Jean. Yes, we can 

15 do that. We've already talked about gathering the 

16 financial data on this, and I know a lot of our 

17 members have plans in place and ideas to address 

18 this.

19 CHAIR FAVRE: Harriet.

20 MEMBER BEHAR: I know it's really in 

21 the certifiers' interest to make sure that they are 

22 using inspectors that are competent and doing a 
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1 good job, so I'm wondering within ACA, are you 

2 working on a system of evaluation that those 

3 various certifiers all feel comfortable with, so 

4 if one certifier evaluates an inspector, the other 

5 certifiers will accept that? Basically looking 

6 for consistency in the evaluation process?

7 MS. KANE: First, I think there is 

8 interest in doing that, and the second is that was 

9 only really put forth as an option in the March 

10 revision of the document, so I know that several 

11 certifiers are talking to other certifiers about

12 that, so I think work will be done on that.

13 CHAIR FAVRE: Harold.

14 MEMBER AUSTIN: Pat, also, if you could 

15 help provide us with some input as you're working 

16 with the other agencies and stuff on gathering the 

17 information, if there would be possibly any 

18 unintended consequences on those that you certify.

19 CHAIR FAVRE: Thank you very much. 

20 MS. KANE: Thank you all.

21 CHAIR FAVRE: Next up is Christie 

22 Badger, followed by Theojary Crisantes, if I got 
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1 anywhere close to that.

2 MS. BADGER: Hi. My name is Christie 

3 Badger, and I'm speaking today on behalf of the 

4 National Organic Coalition. Thank you for the 

5 opportunity to be a part of this exciting process 

6 and thank each of you for all of the work that you 

7 do to further strengthen the integrity of the 

8 organic label.

9 NOC supports the relisting of peracetic 

10 acid to the National List for all uses. However, 

11 we feel that the NOSB would benefit from a view of 

12 sanitizers and disinfectants as a class to aid the 

13 NOSB, organic producers, and the general public 

14 with future reviews of these items as they come 

15 before the Board, either as a new petition or at 

16 sunset.

17 This is a critical next step to be 

18 consistent with the continuous improvement 

19 approach to organic agriculture, which NOC members 

20 strongly endorse. The listing of this class of 

21 materials has been responsive to petitions and 

22 historical use without the benefit of research into 
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1 which could be most compatible with organic 

2 production. This type of research would provide 

3 the NOSB with the background they need to make 

4 informed decisions when these materials come 

5 before the Board. We recommend this topic of 

6 information gathering on sanitizers and 

7 disinfectants be placed on the NOSB work agenda.

8 NOC urges the NOSB to take the sunset 

9 review of List 3 inerts seriously and act in a 

10 timely manner, as it must with the review of all 

11 sunset materials, reviewing to the OFPA criteria 

12 as required by law. While NOC recognizes that the 

13 fall 2015 NOSB recommendations for inerts has been 

14 reviewed by the NOP with plans to collaborate 

15 further with the EPA's Safer Choice program for 

16 future review of inert ingredients, it's 

17 imperative that List 3 inerts are reviewed at this 

18 time to maintain the integrity of the sunset review 

19 process.

20 NOC believes there is a necessary next 

21 step remaining after the approval of the fall's 

22 recommendation for safer choice inerts to be placed 
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1 on the National List. The NOP, with the NOSB 

2 involvement and the EPA, should draft and sign a 

3 Memorandum of Understanding detailing the 

4 interaction of the EPA's Safer Choice program with 

5 the NOP's National List.

6 Materials used in organic production 

7 are subject to the OFPA criteria, and EPA's 

8 criteria for the SCIL do not cover all the OFPA 

9 criteria. Consistent with OFPA, there should be 

10 a mechanism for the NOSB to not allow a subset of 

11 the safer choice inerts, and the method for making 

12 that determination should be part of the MOU.

13 As part of the MOU, interaction between 

14 the NOSB and EPA should continue in order to aid 

15 the EPA in understanding the OFPA criteria and help 

16 the EPA identify inerts that might be questionable. 

17 CHAIR FAVRE: Thank you.

18 MS. BADGER: Thank you.

19 CHAIR FAVRE: Any questions for 

20 Christie? Harriet?

21 MEMBER BEHAR: It's more a question for 

22 Miles. I'm just wondering if there is any 
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1 discussion about a Memorandum of Understanding in 

2 helping us with those inerts and especially 

3 possibly certain safer choice inerts that maybe we 

4 would not want to be used in organic agriculture.

5 MR. McEVOY: Emily.

6 MS. BROWN ROSEN: There's going to be 

7 an update on the Inerts Working Group later in the 

8 agenda with the crops, so I think we can go into 

9 it in more detail then.

10 CHAIR FAVRE: Any other questions? 

11 Harold.

12 MEMBER AUSTIN: Christie, we've gotten 

13 several comments back asking for us to look at an 

14 overall overview of the sanitizers and 

15 disinfectants. I guess my question out there to 

16 you would be what would be the value completely of 

17 lumping those together where like we just now got 

18 back the one for crops for the peracetic acid one, 

19 so we haven't -- that will come forward in our fall 

20 discussion because it was late in arriving. 

21 We're getting more and more TRs back on 

22 all of these materials. Wouldn't we get more
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1 information provided via a TR on a specific 

2 material rather than lumping them all together and 

3 then doing an overview? I guess I'm just trying 

4 to find out what's really driving everybody wanting 

5 to -- the few commenters that have wanted to lump 

6 them together rather than a specific in detail, in 

7 depth TR review on material?

8 MS. BADGER: I can just tell you that 

9 in my work with NOC and helping to coordinate their 

10 work on providing their comments to the NOSB, one 

11 of the things that comes up when new materials are 

12 petitioned or materials come up for review is 

13 looking at is that the best material out there, and 

14 how many other materials are there that can do the 

15 same job. And in our comments, which I hope you've 

16 all had an opportunity to read, you'll see that we 

17 do recognize that we understand that different 

18 materials are needed to do the job in order to not 

19 create say super bugs or whatnot by not having 

20 enough to switch them out. 

21 But I think when you're evaluating new 

22 materials, it's really hard to tell what is 
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1 currently already available and where does it stand 

2 on a list of good, better, best, not good, things 

3 like that.

4 CHAIR FAVRE: Thank you, Christie.

5 MS. BADGER: Thank you.

6 CHAIR FAVRE: Next up.

7 MR. CRISANTES: Yes, I'm fine. 

8 Thanks.

9 CHAIR FAVRE: In the interest of 

10 helping me out here, pronounce your name for me.

11 MR. CRISANTES: Theojary Crisantes. 

12 Theo for short.

13 CHAIR FAVRE: Got it. Thank you. Go 

14 ahead. Bear with us while we're trying to -- there 

15 we go. Not yet. Working on technology issue 

16 again.

17 Michelle, you want to go ahead and just 

18 -- okay. Does he have his presentation there that 

19 he can speak from? Okay. 

20 Why don't we go ahead and let you get 

21 started. I want to apologize for not having the 

22 presentation projected.
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1 MR. CRISANTES: All right, anyways, 

2 good afternoon, ladies and gentlemen, members of 

3 the NOSB Board. My name is Theojary Crisantes. 

4 I'm from Wholesome Harvest. 

5 Today, I would like to address the Board 

6 about organic container growing. Wholesome 

7 Harvest is a family company that has been owned and 

8 operated for three generations of farmers. We 

9 have more than three decades of experience of 

10 organic growing and ten years since all of our 

11 production is 100 percent organic following the 

12 National Organic Program.

13 As a company, we currently have 150 

14 years of combined professional knowledge of 

15 organic growing in our operation. At Wholesome, 

16 we grow organic vegetables in diverse production 

17 methods such as glass houses, protected 

18 agriculture, and open field, in different 

19 locations in Arizona, Sonora, and Sinaloa.

20 The diversity of locations and products 

21 that we grow have led us to find site-specific 

22 requirements to achieve our goals: produce the 
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1 best organic produce possible with the least 

2 possible impact. 

3 Can you just go down more and more and 

4 more and more -- more. There. Yes, please.

5 For the Arizona desert, we have chosen 

6 to grow our tomatoes inside the greenhouse in a 

7 container filled with organic enriched cocoa coir. 

8 To establish the correct biology in the root zone, 

9 we start by soaking the cocoa with our biology-rich 

10 composting, fish emulsion and soil meals. As the 

11 plant roots in, and the symbiosis between the plant 

12 and the microorganisms flourishes, we see an 

13 explosion of life emerging to the point that we can 

14 find a complete ecosystem in our buckets.

15 Next. As you can see in the picture, 

16 a larger number of springtails and earthworms, 

17 next, are found on the surface of the buckets. 

18 These are the visible members of the ecosystem.

19 Next. Here's the bottom line. I 

20 wanted to share with you the results of our recent 

21 biological analysis of our bucket. It shows a 

22 complete ecosystem that includes a high number of 
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1 bacteria, fungi, protozoa, and nematodes with a 

2 total nitrogen-cycling potential of 300 plus 

3 pounds of nitrogen per acre, suitable for 

4 supporting and helping tomato plants.

5 Next. Once we are finished with the 

6 cocoa coir on our tomato crop, we have several uses 

7 for it. Specifically, in our farm in Arizona, we 

8 incorporate the cocoa coir to an open field to grow 

9 Sudangrass as hay, to be used by local farmers to 

10 feed their animals.

11 Next. We are always looking for 

12 solutions and methodologies to foster the cycling 

13 of resources and promote ecological balances and 

14 conserve biodiversity. Thank you very much.

15 CHAIR FAVRE: Thank you, and my 

16 apologies for the technology snafu there. Any 

17 questions for Theo? Thank you very much.

18 Our final commenter today before our 

19 lunch break will be Melody Meyer.

20 MS. MEYER: My name is Melody Meyer. 

21 I'm with United Natural Foods, Incorporated. I 

22 thank you for the opportunity to provide comments. 
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1 I've been up here many times talking about emerging 

2 technologies and synthetic biology, so I'm really 

3 thrilled that you're requesting comments on the 

4 definition of excluded methods.

5 The proposed definitions that are put 

6 forward are a priority, but I do think they need 

7 some revisions. I recommend separating out the 

8 definitions from the rest of the proposal and 

9 moving the definitions forward as an independent 

10 recommendation. 

11 The terminology chart and criteria 

12 principles, they do need more time and attention. 

13 I recommend taking those back to an independent 

14 committee of experts and affected communities for 

15 further work and input. 

16 The goal of this committee would be to 

17 release a final proposal prior to the fall 2016 NOSB 

18 meeting.

19 I recommend as genetic engineering 

20 evolves, and we have these emerging technologies, 

21 so should the definition, and that it should be 

22 broadened to address not just genetic material, but 
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1 genetic systems. I recommend that several to be 

2 determined techniques should be included in the 

3 list of excluded methods before moving the proposal 

4 forward.

5 Regarding the definition, it's best to 

6 utilize the definition used by CODEX over the 

7 Cartagena Protocol definition for several reasons 

8 that I've outlined in the rest of my comments. The 

9 definition of biotechnology should refer to CODEX, 

10 but without the reference to Cartagena because this 

11 adds potential confusion about what is an LMO and 

12 a GMO.

13 Next, I want to comment on seed purity 

14 next steps. Thank you for the opportunity to 

15 provide comments on this. Many think that we can't 

16 really move forward, but I think it's a critical 

17 control point that we do. We shouldn't wait to set 

18 limits for controlling the unintended or 

19 unavoidable presence of GMOs. 

20 Some of the things that I want to 

21 highlight that need attention, NOP seed guidance 

22 does not address the prohibition on excluded 
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1 methods for sourcing of seeds, annual seedings and 

2 planting stock. The NOP seed guidance does not 

3 require growers to contact more than three sources 

4 for seed. NOP's guidance does not establish 

5 organic seed usage as an organic systems planned 

6 goal. It doesn't address the requirements of a 

7 certified buyer or handler purchasing seed 

8 planting stock for contractual growing purposes. 

9 And it should probably reference the Organic Seed 

10 Finder as a resource.

11 I urge the USDA to establish and appoint 

12 a Seed Purity Advisory Task Force whose primary 

13 function would be to design a feasibility study 

14 based on testing and data collection. The study 

15 would evaluate a rigorous and realistic threshold 

16 supporting the seed purity standard for 

17 non-organic seeds. 

18 And my final comment was on 

19 biodegradable mulch. I'll keep bringing that up. 

20 I think that should be an allowed tool for organic 

21 farmers as we seek continuous improvement. Thank 

22 you very much for your hard work and especially to 
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1 the NOSB for all the time you put in. Let's have 

2 lunch.

3 CHAIR FAVRE: Zea, you had a question?

4 MEMBER SONNABEND: Thank you, Melody, 

5 on the excluded methods terminology comment, how 

6 do you suggest such an independent scientific task 

7 force get organized, recruited and funded before 

8 the fall meeting?

9 MS. MEYER: I don't have an answer to 

10 that right at this moment, but I could help you 

11 brainstorm on it. I think there is more input 

12 needed from the community.

13 CHAIR FAVRE: Any other questions? 

14 Thank you. And I think we will now break for lunch.

15 Folks, we want to be back here promptly 

16 for the first commenter to start at 2:00 and that 

17 would be Jim Gerritsen. So Jim, if you'll make 

18 sure you're here right at 2. Thank you.

19 (Whereupon, the above-entitled matter 

20 went off the record at 12:55 p.m. and resumed at 

21 2:01 p.m.)

22 CHAIR FAVRE: Okay, folks. By my 
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1 reckoning we've got one minute after 2:00. If all 

2 the Board members would take their seats.

3 Thank you, Jim, for being here on time 

4 as I requested.

5 Okay. We're going to start back with 

6 public comments again. First up for the afternoon 

7 is Jim Gerritsen. On deck is Julie Weisman.

8 Thank you, Jim

9 MR. GERRITSEN: I'm Jim Gerritsen. 

10 I've been farming for 40 years on Wood Prairie Farm 

11 in the State of Maine. We've been certified 

12 organic by MOFGA for 34 years and I have served as 

13 a volunteer on the MOFGA Certification Committee 

14 for 25 years. 

15 In addition to farming full time I am 

16 president of Organic Seed Growers and Trade 

17 Association and I serve as a policy advisor to the 

18 Cornucopia Institute. 

19 I'm also a member of a group of 

20 experienced organic farmers, each with decades of 

21 organic farming experience, totaling over 1,000 

22 years. This group is called the Agrarian Elders. 
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1 I'd like to read into the record from this letter, 

2 and I've placed that letter at each of your desks 

3 there. It's signed by 22 elders.

4 "Dear NOSB members, as agrarian elders 

5 we want to tell you how concerned we are about the 

6 organic farming movement losing connection with 

7 its roots and traditional organic concepts. Here 

8 are some examples.

9 "Production of milk, meat and eggs from 

10 giant CAFOs which overtly skirt the letter and 

11 spirit of the organic law, betraying consumer 

12 trust, the flood of imported organic commodities, 

13 including corn and soybeans, now making up the 

14 majority of the market and shutting out U.S. 

15 farmers. Allowing hydroponics to be certified as 

16 organic is just one area where the USDA has refused 

17 to respect the NOSB and its past deliberations and 

18 is defrauding the public. The current wholesale 

19 usurping of the historic NOSB process through 

20 shifting the power of board governance from the 

21 NOSB to the USDA NOP leadership. 

22 "We are writing respectfully to ask you 
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1 to consider carefully the research that is 

2 performed by the Cornucopia Institute and other 

3 non-profits respected by the organic farming 

4 community in your deliberations."

5 The letter continues, but it is signed 

6 by 22 elders: Michael Ableman, Foxglove Farm, 

7 British Columbia; Eliot Coleman and Barbara 

8 Damrosch, Four Seasons Farm, Maine; Jean-Paul 

9 Courtens, Roxbury Farm, New York; Gloria and Steve 

10 Decatur, Live Power Farm, California; Carly 

11 DelSignore, Tide Mill Farm, Maine; Jim Crawford, 

12 New Morning Farm, Pennsylvania; Jim Gerritsen, 

13 Wood Prairie Family Farm, Maine; Jake Guest, 

14 Killdeer Farm, Vermont; Andrea Hazzard, Hazzard 

15 Free Farm, Illinois; Betsy Hitt, Peregrine Farm, 

16 North Carolina and others.

17 CHAIR FAVRE: Thank you. Any 

18 questions for Jim? Tom?

19 VICE CHAIR CHAPMAN: Hi Jim. I have a 

20 question related to your written comments. OSGATA 

21 was the only organization who wrote in opposition 

22 to the sunset reorganization for 2017 items to 
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1 spread it evenly throughout the years.

2 MR. GERRITSEN: Can you speak up a 

3 little bit, Tom?

4 VICE CHAIR CHAPMAN: Yes, OSGATA was --

5 can you hear me now?

6 MR. GERRITSEN: Yes.

7 VICE CHAIR CHAPMAN: OSGATA was the 

8 organization who wrote in opposition to these 

9 sunset reorganization for 2017 to spread those 

10 materials evenly across the years. Can you speak 

11 to your opposition to that?

12 MR. GERRITSEN: I don't recall that as 

13 being part of our comments. If it was, I would say 

14 that that was a mistake.

15 VICE CHAIR CHAPMAN: Okay. 

16 MR. GERRITSEN: We do have opposition 

17 to the Board moving on the sunset rule since OSGATA 

18 is one of the 10 plaintiffs in litigation against 

19 the USDA because we feel that that action was 

20 illegal.

21 VICE CHAIR CHAPMAN: So you meant those 

22 comments against the PPM, not against the sunset?
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1 MR. GERRITSEN: I'd have to look at 

2 them to be sure, but we think that there needs to 

3 be some common sense, and it needs to be spread out 

4 evenly. So if we did err in those comments, the 

5 intent is to try to make it reasonable for you as 

6 a board and evening them out.

7 VICE CHAIR CHAPMAN: Thank you.

8 MR. GERRITSEN: Yes.

9 CHAIR FAVRE: Any other questions?

10 (No response.)

11 MR. GERRITSEN: Thank you.

12 CHAIR FAVRE: Thank you very much.

13 Okay. Next is Julie Weisman, and 

14 following that is Cameron Harsh on deck.

15 MS. WEISMAN: Good afternoon. My name 

16 is Julie Weisman. As an owner of Elan Vanilla and 

17 Flavorganics I have been making certified organic 

18 vanilla extract for almost 20 years now. 

19 I served on the NOSB from 2005 to 2010, during 

20 which time I chaired the Handling Committee and 

21 served as both secretary and vice-chair of the 

22 Board. I extend a hearty welcome to the six new 
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1 members. Thank you in advance for your hard and 

2 important work that you'll be doing for the next 

3 five years.

4 I will talk today about excluded 

5 methods. The language crafted in 1995 was a 

6 cornerstone of our infant rule; however, an update 

7 of the NOP's language and regulations regarding 

8 excluded methods, and genetic engineering in 

9 particular has suddenly become long overdue. The 

10 technology has become so complex and fast changing 

11 that the way the NOP limits their use may require 

12 a different structure. 

13 The NOP, with NOSB oversight of 

14 rulemaking, is a deliberate and thorough process 

15 and it should remain ever so. However, it may not 

16 be a good fit with keeping abreast of the onslaught 

17 of new methods placing novel organisms in the 

18 supply chain and into the stream of commerce.

19 In my tiny corner of the organic supply 

20 chain, vanillin, normally produced in vanilla 

21 beans and other plants, is now excreted by 

22 genetically re-engineered yeast. This vanillin 
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1 is used in flavors, and such flavors may be labeled 

2 and sold as natural because under FDA definitions 

3 products of fermentation are natural, without 

4 regard to the provenance of the organism doing the 

5 fermenting. 

6 Makers of NOP-compliant flavors; 

7 that's not organic flavors, are often not certified 

8 organic and not themselves familiar with NOP 

9 regulations on GMOs. They may have no idea that 

10 their ingredient contains a product of genetic 

11 engineering.

12 Now, this particular conundrum will be 

13 remedied by adding language to flavor 

14 questionnaires that asks if the flavor contains 

15 natural vanillin as we currently do for citric 

16 acid. And it will also be remedied once the new 

17 annotation prioritizing use of organic flavors, 

18 which was passed in Vermont in the fall, becomes 

19 a final rule. 

20 However, in considering the potential 

21 universe of threats posed by genetic engineering 

22 to the organic industry, a more proactive procedure 
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1 may be called for, and I therefore support the 

2 suggestion of my colleague Dag Falck at Nature's 

3 Path, that with regard to GE methods the NOP move 

4 from defining excluded methods to defining allowed 

5 methods.

6 And further, I recommend that the 

7 allowance of new methods occur through the use of 

8 the same petition process that we currently use to 

9 add substances to the National List. Might even 

10 be a new section on the List. This would bring 

11 consideration of these novel technologies into the 

12 sunlight and provide an opportunity for public and 

13 often expert comment which has served the rule and 

14 this industry so well. 

15 So in summary, please consider a revamp 

16 of the treatment of genetic engineering under the 

17 National Organic Program so that many horses will 

18 not have a chance to dash out before we stakeholders 

19 of the NOSB and the program have a chance to close 

20 the barn door. Thank you.

21 CHAIR FAVRE: Thank you, Julie. Any 

22 questions for Julie? Zea?
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1 MEMBER SONNABEND: Thank you, Julie. 

2 Could you give an example of what you mean by a 

3 process we would put on the National List?

4 MS. WEISMAN: Well, what I mean 

5 generally is that instead of having the National --

6 we have been focused on excluded methods, and the 

7 current endeavor right now is to refine the 

8 definition of excluded methods to take into account 

9 all of the changes that have occurred since 1995. 

10 And I'm suggesting that the rate at 

11 which these changes will come at us are too fast 

12 for this process, and that if instead it were 

13 possible -- I don't know if it is, but in my 

14 imagination it is possible -- to have a list that 

15 is a positive list of allowed methods, and that new 

16 technologies cannot be used until after they have 

17 been reviewed in the same way that we've reviewed 

18 new substances and then added to the list of allowed 

19 methods. That's my fantasy.

20 MEMBER SONNABEND: And this can be done 

21 without a rule change when the rule already says 

22 excluded? And I still would want to hear an 
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1 example of what you mean.

2 MS. WEISMAN: Well, in other words, 

3 there are a number of techniques which everyone 

4 does agree are already -- are excluded. But there 

5 are a lot of things that are being debated and 

6 parsed out right now in this public comment 

7 process. Some people believe that CRISPR is part 

8 of the villains and other people have pointed out 

9 that it's something that occurs naturally in plants 

10 already, in bacteria, I guess. 

11 So I think that the time that it's going 

12 to take -- and this process should take time. 

13 That's what's important about it. But in the 

14 meantime, all these other technologies are being 

15 loosed upon the environment before we have a chance 

16 to hammer them down. And that is only going to 

17 accelerate. 

18 I feel like I'm not answering your 

19 question yet, Zea. I'll give it more thought.

20 CHAIR FAVRE: Any other questions?

21 (No response.)

22 CHAIR FAVRE: Thank you very much.
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1 Okay. Next up is Cameron Harsh, and 

2 we've got Abby Youngblood on deck.

3 MR. HARSH: Good afternoon. My name 

4 is Cameron Harsh. I am the senior manager of 

5 organic and animal policy at Center for Food 

6 Safety. I want to thank the Board for your 

7 commitment to organic.

8 CFS is disheartened by the late posting 

9 of the opportunity to comment which cut the time 

10 available for the Board to review written comments 

11 by half compared to previous meetings.

12 On policy and procedures, we appreciate 

13 the transparent documentation of all proposed 

14 revisions. The manual functions as bylaws for 

15 NOSB and is crucial to a strong organic process. 

16 Control of the language must remain with NOSB, and 

17 revisions must not reduce its functioning as an 

18 autonomous advisory body to NOP. Certain proposed 

19 revisions reduce the authority and independence of 

20 NOSB, including initiating agenda items and 

21 establishing its own procedures. Suggested 

22 revisions regarding minority opinion procedures 
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1 reduce transparency and the ability of the full 

2 board to consider diverse perspectives. More work 

3 is also needed to bring the manual into full 

4 alignment with FACA.

5 On sunset review, we understand that 

6 the sunset review schedule unfairly burdens the 

7 Board, NOP and the public in certain years and 

8 affirm the subcommittee's recognition the review 

9 dates must only be moved ahead in compliance with 

10 OFPA. CFS supports grouping materials by their 

11 similar function or use in organics, such as option 

12 B. This facilitates considerations of 

13 essentiality, as materials that address similar 

14 needs are reviewed on the same cycle, and supports 

15 the intent that the National List is meant to 

16 decrease over time.

17 Squid and squid byproducts. Due to the 

18 environmental impacts of squid harvesting, such as 

19 destruction of benthic Habitat and bycatch of 

20 endangered species, any allowance of squid-based 

21 fertilizers in organic must not lead to increased 

22 harvesting of wild squid. While the recycling of 
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1 waste from the squid food industry is positive, 

2 manufacturers of fertilizers should not be allowed 

3 to source whole squid. Research also indicates 

4 high heavy metal contamination of squid 

5 byproducts, particularly liver and muscle, as well 

6 has high leaching potential of squid-based 

7 fertilizers. These issues should be addressed 

8 before moving forward with the petition.

9 Copper sulfate. Before voting on 

10 copper sulfate more research is needed regarding 

11 whether non-target aquatic species that are killed 

12 by the toxic effects of copper may provide suitable 

13 algae and tadpole shrimp control if their 

14 populations were instead allowed to flourish. 

15 Carrageenan. CFS has consistently 

16 urged NOSB to remove carrageenan due to its 

17 incompatibility with organic. Several 

18 researchers from a number of institutions have 

19 demonstrated potential harm from the breakdown of 

20 carrageenan during digestion. Further, the 

21 subcommittee's comparison of harm from consuming 

22 carrageenan to a food sensitivity is an inaccurate 
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1 analogy. It is a plant extract used as a food 

2 additive, not a food or an actual component of a 

3 food in and of itself. Additionally, research 

4 suggests that all people could be affected by 

5 degraded carrageenan to varying degrees. Lastly,

6 as several companies have already removed it, it 

7 is clearly not essential and should not remain on 

8 the National List. 

9 Vitamins and minerals. CFS continue 

10 to advocate for removing the categorical listing 

11 of vitamins and minerals and requiring that 

12 individual materials intended for fortification of 

13 foods be individually petitioned for inclusion as 

14 required by OFPA. Many materials already listed 

15 individually are sources of the desired vitamins 

16 and minerals, and would not need to be 

17 re-petitioned. CFS supports the proposal put 

18 forward by the National Organic Coalition in its 

19 written comments. 

20 Finally, on hypochlorous acid, the 

21 Board must review the potential addition of 

22 hypochlorous acid within the context of similar 
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1 materials already listed, as well as the physical 

2 and non-chemical sanitation practices that should 

3 be encouraged. Thank you.

4 CHAIR FAVRE: Good job. Any questions 

5 for Cameron? Zea and then Tom.

6 MEMBER SONNABEND: Thank you. You 

7 didn't comment on the excluded methods 

8 terminology. Is someone else from Center for Food 

9 Safety planning to talk about that or --

10 MR. HARSH: Yes, I'll be leaving that 

11 to Jaydee Hanson, who will comment tomorrow.

12 MEMBER SONNABEND: Tomorrow there will 

13 be someone to comment?

14 MR. HARSH: Yes, tomorrow morning.

15 MEMBER SONNABEND: Okay. I'll wait 

16 for that.

17 CHAIR FAVRE: Tom?

18 VICE CHAIR CHAPMAN: You mentioned 

19 FACA in your comments there very briefly. Can you 

20 go over that again? What was your comment?

21 MR. HARSH: Yes. So in our written 

22 comments it elaborates in more detail, but one of 
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1 the issues is that the proposed revisions conflates 

2 two positions, one being the committee member of 

3 the CMO and the DFO are the acronyms. I can find 

4 exactly what those stand for. 

5 PARTICIPANT: Committee management 

6 officer.

7 MR. HARSH: Yes, committee management 

8 officer. Thank you so much. So many acronyms.

9 PARTICIPANT: And designated federal 

10 officer.

11 MR. HARSH: And the designated federal 

12 officer. Their roles have been conflated in the 

13 proposed revisions, and also there is still some 

14 work for record keeping requirements under FACA, 

15 as two examples. But again, our written comments 

16 go into further detail.

17 VICE CHAIR CHAPMAN: What were the 

18 record keeping? Can you speak to those?

19 MR. HARSH: Yes. It's in relation to 

20 the minutes of advisory committee meetings and 

21 submitting record keeping under FACA instead of 

22 FOIA, which has been addressed to some degree in 
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1 the new revisions, but not fully. 

2 VICE CHAIR CHAPMAN: What piece of the 

3 FACA disclosure under our new revisions is not 

4 fully met?

5 MR. HARSH: That would be a question 

6 that I can answer later based on our attorneys that 

7 have done the assessment of the revisions.

8 VICE CHAIR CHAPMAN: Okay. Thank you. 

9 I'd be interested in that.

10 CHAIR FAVRE: Dan?

11 MEMBER SEITZ: I didn't quite fully 

12 catch your comments on squid and squid byproducts. 

13 I understand that you wouldn't want people to catch 

14 squid to use that as fertilizer, but are there any 

15 problems with the byproducts apart from catching 

16 whole squid from your understanding?

17 MR. HARSH: There is research, and we 

18 have cited a number of studies in our written 

19 comments to suggest that there are some issues with 

20 cadmium and copper levels in certain squid 

21 byproducts, particularly the liver and the muscle. 

22 So that would be one issue, heavy metal 
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1 contamination, that we'd want looked into further. 

2 Another issue is the high nitrogen leaching 

3 potential from fertilizers that are using squid.

4 CHAIR FAVRE: Thank you.

5 Next up is Abby Youngblood, followed by 

6 Michael Sly on deck.

7 MS. YOUNGBLOOD: Good afternoon. My 

8 name is Abby Youngblood, and I'm the executive 

9 director at the National Organic Coalition. And 

10 I want to say welcome to new Board members, and 

11 thank you to all of you for your work.

12 I want to talk first about the role of 

13 the NOSB, and then I want to touch quickly on a few 

14 of the materials that we commented on.

15 The NOSB plays a critical role by 

16 serving as a link between the organic community and 

17 the USDA by representing and balancing the 

18 interests of diverse stakeholders and by 

19 maintaining a level of autonomy from the USDA that 

20 is absolutely essential if the organic label is to 

21 have the trust of farmers and citizens alike. 

22 NOC believes the NOSB must have the 
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1 authority to set its own direction and agenda and 

2 we urge the NOSB to maintain control over the Policy 

3 and Procedures Manual, or PPM. Changes to the PPM 

4 must be transparent and submitted with full 

5 justification, and we urge you to not allow the PPM 

6 to be weakened in such a way that it infringes on 

7 the NOSB's authority. We support integrating 

8 minority opinions held by subcommittee members 

9 into NOSB recommendations for consideration by the 

10 full Board and public. 

11 Expanding organic production by 

12 destroying endangered ecosystems is unacceptable, 

13 and we would like to see the NOSB address this issue 

14 on its work plan and work with leaders in the 

15 organic community such as Wild Farm Alliance to 

16 provide a path forward. And we believe that 

17 addressing this issue is fully within the Board's 

18 statutory authority, and in fact believe that it's 

19 the Board's responsibility to go beyond reviewing 

20 National List materials as you've done in so many 

21 other cases to examine and propose solutions for 

22 critical issues that could harm the integrity of 
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1 the organic label.

2 We ask that the Board uphold all of the 

3 OFPA criteria in your review of petition and sunset 

4 materials and we agree with the Handling and Crops 

5 Subcommittees that oat beta-glucan and ash from 

6 manure burning do not meet OFPA criteria. We urge 

7 the Board to reject these materials. 

8 Carrageenan does not meet OFPA 

9 criteria. It's not essential for production of 

10 organic food and may have negative human health 

11 impacts as my colleagues from Consumers Union and 

12 CFS describe in detail, and it should be removed 

13 from the National List. 

14 Nutrient vitamins and minerals should 

15 be removed from the National List and reviewed 

16 individually to OFPA criteria, and we support the 

17 Handling Subcommittee's efforts to fix the listing 

18 and annotation and provide a specific proposal in 

19 our comments about how option 1 could be modified 

20 to accomplish this. According to our analysis, 

21 only a handful of nutrients would require petition 

22 and review. 
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1 Thank you, NOSB members, for your hard 

2 work and for this opportunity to testify.

3 CHAIR FAVRE: Thank you. Jean?

4 MEMBER RICHARDSON: Abby, can you help 

5 me with the minority opinion piece? You probably 

6 wrote this in your materials and I'm just not 

7 remembering it, but did you have some specific 

8 language that you would be recommending to modify 

9 or edit what we had for the minority opinion? 

10 Because our goal in doing that was that indeed 

11 minority opinions would be absolutely incorporated 

12 into the recommendation. What we're trying to 

13 avoid is having the recommendation written, ready 

14 to be voted, or about to be voted, or voted --

15 MS. YOUNGBLOOD: Yes.

16 MEMBER RICHARDSON: -- and then a bunch 

17 of people say, hey, we have a different approach. 

18 We're trying to avoid --

19 MS. YOUNGBLOOD: Yes.

20 MEMBER RICHARDSON: -- that. 

21 MS. YOUNGBLOOD: And we're 

22 supporting --
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1 MEMBER RICHARDSON: What we want is 

2 consensus.

3 MS. YOUNGBLOOD: We're supporting 

4 that. So in our comment we're saying that we 

5 support the language that would incorporate that 

6 minority opinion.

7 MEMBER RICHARDSON: Okay.

8 MS. YOUNGBLOOD: So thank you for --

9 MEMBER RICHARDSON: Okay. Thank you.

10 MS. YOUNGBLOOD: -- making that

11 change.

12 CHAIR FAVRE: Thank you very much.

13 Okay. Next up is Michael Sly, followed 

14 by Linley Dixon on deck.

15 MR. SLY: Good afternoon. I'm Michael 

16 Sly with the Rural Advancement Foundation 

17 International. 

18 I rise mostly to speak about seeds and 

19 new genetic techniques, but I would also say that 

20 I support NOC's particular concerns around 

21 changing the procedures manual, particularly here 

22 at the end of administration, when we don't know 
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1 really who will be here in the future. So I think

2 it's important that we kind of keep a level hand 

3 as we go into this new administration. So I urge 

4 that we don't tilt this delicate balance that we've 

5 created and was observed in OFPA. 

6 But I'm here to talk about seeds. 

7 Particularly, we found on the original NOSB that 

8 the criteria of compatibility with sustainable 

9 agriculture to be a key touchstone for us when we 

10 came across genetic engineering back in the day. 

11 I suggested that is a very good criteria for you 

12 to look at because it is already defined by USDA. 

13 It includes a much bigger framework and allows us 

14 to look at the implications of new technology on 

15 the very structure of organic agriculture.

16 I particularly want us to make sure that 

17 we don't get lost in the weeds on this one, because 

18 this is really one that requires our clearest 

19 vision, and it is an opportunity for us to 

20 communicate to the larger agricultural sector 

21 about what is compatible with a system of 

22 sustainable agriculture. Why would we want to 
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1 exclude something and for what reason? It's a 

2 really good teachable moment, that we should seize 

3 this moment.

4 I'm going to provide many more criteria 

5 in my written comments, but I want to focus on just 

6 a couple of realities that are important when we 

7 think about these new techniques. I think it's 

8 important to understand that the overall seed 

9 industry is already highly concentrated and 

10 consolidated and it is driving genetic uniformity 

11 and a loss of regionally adapted varieties. 

12 So we need to be very careful in 

13 thinking about any new technique that will include 

14 a utility patent, which these do already. And we 

15 would expect that these new techniques would not 

16 only have a utility patent, they would also have 

17 restrictive use agreements. And this will in many 

18 ways prevent plant breeders in the public sector 

19 and farmers from saving these seeds, from improving 

20 these seeds, and will further push organic 

21 agriculture and seed production even further 

22 behind.
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1 So I caution us to not go down that road 

2 at this point. We think that we can't see utility 

3 patents being compatible with a system of 

4 sustainable agriculture.

5 We do also call on the NOSB to urge USDA 

6 to put more priority on funding public cultivar 

7 development.

8 CHAIR FAVRE: Thank you.

9 MR. SLY: Thank you.

10 CHAIR FAVRE: Questions for Michael? 

11 Zea?

12 MEMBER SONNABEND? Thank you. 

13 Michael, could you explain how what you just said 

14 specifically relates to our proposal on the table?

15 MR. SLY: Yes, I mean, I think your 

16 proposal is really good work, Zea. And we did meet 

17 with the Organic Seed Alliance and got a bunch of 

18 the plant breeders on a phone call, and we looked 

19 at the definitions. And we think that it needs 

20 some more clarity to be clear about what is excluded 

21 and what is not included. 

22 And we also think that actually it would 
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1 be a better route if we would look at defining what 

2 is organic plant breeding, that that may be a better 

3 route for us to go in terms of including this 

4 discussion of what is excluded by saying what we 

5 think should be included. 

6 So I will provide this in written 

7 comment, Zea. I apologize. I couldn't -- as a 

8 Southerner, I can't say much in three minutes.

9 MEMBER SONNABEND: Well, of course you 

10 realize that the under-text of what you just said 

11 is like let's wait 10 more years while we develop 

12 organic --

13 (Simultaneous speaking.)

14 MR. SLY: No, I'm not saying wait 10 

15 more years. And I mean, the international organic 

16 community is already moving rapidly ahead on this 

17 and we're participating in that. 

18 MEMBER SONNABEND: And how long --

19 (Simultaneous speaking.)

20 MR. McEVOY: And I understand your term 

21 is coming up, and we would love to see clarity on 

22 this before you leave, Zea, but --
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1 MEMBER SONNABEND: But how long has the 

2 international community worked on this so far?

3 MR. SLY: Couple of years. Couple of 

4 years.

5 MEMBER SONNABEND: Or 10?

6 MR. SLY: Yes.

7 (Laughter.)

8 MR. SLY: But I would urge that I think 

9 we should take advantage of the number of organic 

10 plant breeders that are out there and NGOs and 

11 farmers that are working very hard on these 

12 techniques and bring them into this closely so that 

13 we can get this right the first time. It's quite 

14 critical that we not be too vague, because if we're 

15 too vague, it will come back to haunt us. So that's 

16 really our main concern is that it needs to be 

17 tightened up. And we can provide that additional 

18 information.

19 CHAIR FAVRE: Dan?

20 MR. SLY: Thank you.

21 MEMBER SEITZ: I have a question.

22 CHAIR FAVRE: Hold on just a minute. 
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1 We have one more question for you.

2 MR. SLY: Oh.

3 MEMBER SEITZ: Just can you more 

4 explicitly make a connection between the work of 

5 the NOSB and how steps on our part will work to keep 

6 a further consolidation of the seed industry and 

7 a further loss of varieties?

8 MR. SLY: Yes.

9 MEMBER SEITZ: How do those things 

10 connect?

11 MR. SLY: Yes, I mean, the issue that 

12 we're concerned about is that we have had this rapid 

13 decline in public cultivar development and funding 

14 at the federal level, particularly at USDA. And 

15 many of us have been working very hard to try to 

16 change that trend line. And you'll have Dr. Tracy 

17 here tomorrow who probably can corroborate that 

18 better than I can, but our concern is that if in 

19 the larger context we're already behind and have 

20 limited resources to fund public cultivar 

21 development, which is where organic farmers 

22 currently are turning to to find compatibility with 
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1 organic, because the organic seed industry is still 

2 very much in its infancy. We don't have enough 

3 organic seeds to meet the locally-adapted needs of 

4 farmers all over the world yet. We're trying to 

5 build that infrastructure. 

6 But if we allow utility patents to creep 

7 into organic plant breeding and to be allowed 

8 through these new techniques, we will further 

9 constrain the ability to innovate more rapidly. 

10 That's my point there, is that that's the key that 

11 we're seeing as a direction that is not useful for 

12 a system of sustainable agriculture. There are 

13 many other ways to reward breeders without using 

14 a utility patent. Thank you.

15 CHAIR FAVRE: Thank you. 

16 Next up is Linley Dixon, and Jake Lewin

17 is on deck.

18 DR. DIXON: My name is Linley Dixon and 

19 I'm a scientist for the Cornucopia Institute. I 

20 have submitted extensive written comments on the 

21 carrageenan controversy. 

22 In my former live before I became a 
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1 farmer I was a Ph.D. molecular biologist for the 

2 USDA Agriculture Research Service. Even so, I 

3 admit I initially fell for the carrageenan 

4 industry's story. When I say the industry, I mean 

5 this group of companies and scientists from United 

6 for Food Science that all profit from carrageenan, 

7 the group that produced the pig feeding study that 

8 JECFA largely based their decision regarding 

9 carrageenan safety. Nearly all the studies 

10 showing its safety can be traced back to this group. 

11 It's also this group that produced the Facebook 

12 campaign that submitted to you over 1,100 identical 

13 comments on carrageenan.

14 FMC, an $8 billion conglomerate, is 

15 coordinating the effect to discredit public 

16 research. All we're doing is letting consumers 

17 know that this quality public research exists. 

18 The industry that claims that sounding 

19 the alarm on carrageenan are simply confused 

20 between poligeenan and carrageenan. We are not 

21 confused. They're both extracted from red 

22 seaweed, but poligeenan is produced by subjecting 
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1 carrageenan to acid and high temperatures and has 

2 a much lower average molecular weight, between 10 

3 to 20 kilodaltons. 

4 But what the industry doesn't readily 

5 admit is that the higher average molecular weight 

6 of food grade carrageenan doesn't preclude the 

7 presence of smaller amounts of harmful low 

8 molecular weight forms. The term "average" would 

9 obscure that presence. This presence is confirmed 

10 by studies of both publicly and industry-funded 

11 studies. There is a scientific consensus on the 

12 presence of low molecular weight forms in food 

13 grade carrageenan and many labs around the world 

14 are investigating its effects.

15 The carrageenan industry attempts to 

16 pinpoint one lab and claim that they don't have good 

17 laboratory practices, or GLP. It didn't take much 

18 investigation to find out that it's not just 

19 Tobacman's lab at the University of Chicago that 

20 has published on the harmful effects of food grade 

21 carrageenan, but also the University of Calgary, 

22 Alberta, the Metabolic Phenotyping Center at
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1 Vanderbilt, the University of Tubingen in Germany 

2 and Pusan National University School of Medicine 

3 in South Korea.

4 The peer review process and the 

5 high-calibered journals that these groups have 

6 published in means more than the industry's 

7 self-defined GLP for carrageenan and publications 

8 in Critical Reviews in Toxicology, an 

9 industry-friendly journal that the Center for 

10 Public Integrity has called brokers of junk 

11 science.

12 In addition, the industry has tried to 

13 discount studies in human colonic epithelial cell 

14 line MCM460. This cell line is routinely used in 

15 many cell culture studies because it enables 

16 survival and culture. Any scientist can quickly 

17 see this argument doesn't hold when there are 

18 proper controls, repetitions and data that are 

19 analyzed by appropriate statistics. Plus there 

20 are also studies showing harm in normal human 

21 colonic epithelial cells. 

22 Over the last three years, in 
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1 collaboration with Dr. Tobacman and her team at the 

2 University of Illinois, Cornucopia has gathered 

3 information from individuals who have eliminated 

4 carrageenan from their diets and noticed a 

5 resulting health change. To date, there are 1,300 

6 individuals that have found their way to our web

7 site and every one of them has medical details 

8 regarding better health. 

9 And the only thing I would like to end 

10 with is that if there were a open docket between 

11 now and the vote, you would get to hear all those 

12 stories and read them for yourselves.

13 CHAIR FAVRE: Thank you. Anybody have 

14 questions for Linley?

15 (No response.)

16 CHAIR FAVRE: Thank you very much.

17 Next up is Jake Lewin, with Christopher 

18 Peot on deck.

19 MR. LEWIN: All right. Hi, everybody. 

20 My name is Jake Lewin. I'm the president of CCOF 

21 Certification Services. I've worked in organic 

22 farming inspection and certification for 18 years.
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1 CCOF Certification Services is the 

2 non-profit certification arm of the member-based 

3 non-profit CCOF. After starting it on a kitchen 

4 table in Santa Cruz, California and playing a major 

5 role in standards development and the NOP, we 

6 certify about 3,200 operations in the U.S., Mexico 

7 and Canada, including about 2,000 farms and about 

8 1,000 processors. We perform about 4,700 

9 inspections annually.

10 Our organizational mission is to make 

11 organic the norm. We do this through 

12 certification, advocacy and promotion. We want to 

13 see organic grow and the standards evolve and 

14 address new and modern challenges. Each year we 

15 provide funding to future organic farmers, provide 

16 organic farmer hardship assistance and support the 

17 certification of educational institutions and 

18 incubators by providing certification free of 

19 charge.

20 One area that we pride ourselves in is 

21 information management and the use of technology. 

22 These efforts allow us to provide you highly 
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1 accurate information about the content of organic 

2 system plans. However, these are people to us and 

3 we ask you to see them that way. I ask you to look 

4 at our written comments and whenever you see us 

5 reporting, even reporting on producers that 

6 include a material in the OSP, we ask you to see 

7 people. They're not just numbers. 

8 We struggle to get operations to 

9 understand and engage in this process. We strive 

10 to not approach your deliberations as an all or 

11 nothing or to over-dramatize the situation. In 

12 many instances we're simply left bringing you the 

13 facts that there are real individuals in our system 

14 we know are affected by your decisions. We have 

15 tried to be helpful and constructive on issues like 

16 residue testing, GMO testing, inspector 

17 evaluations and countless other improvements to 

18 the program as a whole. We're not afraid of change 

19 and we want organic to evolve and we to evolve with 

20 it. 

21 We firmly believe in organic being 

22 non-GMO and have pioneered an organic is non-GMO 
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1 and more seal. I am personally really troubled by 

2 GMOs and how to continually improve their exclusion 

3 from organic. We support the work on seed purity, 

4 but are challenged regarding how to apply it 

5 effectively. We are pursuing GMO testing, and if 

6 we find contamination, we need the help and a good 

7 system for pursuing problems down the supply chain. 

8 The end point is going to be the seed, but that's 

9 going to be hard. 

10 We're ready to do the work. In fact, 

11 I think we already have some of that authority, but 

12 I can't figure out how to do it fairly. This is 

13 something that needs a lot of work, and we really 

14 encourage you to pursue it. I ask you to be fair, 

15 open-minded and generous in your deliberations, 

16 then vote honestly. Vote your conscience and be 

17 fair and we will live, work with and respect the 

18 outcomes. 

19 I want to really thank you for your 

20 service to the organic community, and I want to 

21 congratulate the NOP on the proposed rulemaking on 

22 organic livestock and poultry practices. I think 
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1 that's a great thing.

2 Thank you, Jake. Any questions for 

3 Jake?

4 (No response.)

5 CHAIR FAVRE: Thank you very much. 

6 Okay. Next up is Christopher Peot, followed by 

7 Liana Hoodes.

8 MR. PEOT: Hi. Thank you. I really 

9 appreciate the opportunity here. My name is Chris 

10 Peot. I'm a process engineer, and I'm the director 

11 of resource recovery for D.C. Water, the local 

12 water utility. We treat drinking water, serve all 

13 of the residents of D.C., but we also treat waste 

14 water, and I, among other things, manage the 

15 biosolids reuse program. 

16 Today I'd like to talk a little bit 

17 about the existing organic standard, and there's 

18 a provision in there that prohibits the use of 

19 biosolids because of the potential of 

20 contamination in organic farms. And that 

21 potential is there, but product quality varies 

22 greatly amongst our industry.
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1 What I'm here to ask is for 

2 consideration of revisiting the prohibition of 

3 biosolids, not to get rid of it altogether, but to 

4 consider a science-based standard, because right 

5 now it's not based on any science. It's just the 

6 potential of some contaminants there.

7 We strongly, strongly support the 

8 mission of USDA and the organics rule. We feel 

9 like we -- what we do gets towards some of those 

10 same goals. We don't even consider ourselves or 

11 refer to ourselves as a waste water treatment plant 

12 anymore, but rather as a resource recovery facility 

13 recovering water, of course the world's most 

14 precious commodity, but also nutrients, carbon and 

15 energy. 

16 And we understand that the nutrient 

17 cycle needs to be closed. In many cases we 

18 harvest -- as urban dwellers, we harvest organic 

19 matter and nutrients from rural areas, bring them 

20 into cities, process them through our bodies. 

21 They end up at the treatment plant, and a lot of 

22 times those organics get locked in the landfill, 
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1 which isn't good. It's not sustainable. And we 

2 would like to see as much of that get onto the land 

3 as possible.

4 The benefits of biosolids use are 

5 slow-released nitrogen, carbon sequestration, 

6 avoidance of inorganic fertilizer and the 

7 associated energy required to produce it. There 

8 is bound phosphorus, which means that it's slowly 

9 released in biosolids. We have research that 

10 shows that there's crop yield increases, a crop 

11 drought tolerance -- which is incredibly important 

12 in these times of climate change -- and it 

13 dramatically reduces our carbon footprint as a 

14 city. So many of the things that I think USDA is 

15 very interested in.

16 The backbone of our program has always 

17 been agriculture, and our farmers have always 

18 anecdotally told us that they can get through 

19 drought conditions better when they use biosolids 

20 as opposed to inorganic fertilizer, and they get 

21 higher crop yields. We now have research that 

22 definitively shows why that is happening. I'm 
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1 going to submit some papers here from Virginia Tech 

2 for the record, please. 

3 Thank you. I think my time is up. I 

4 appreciate it.

5 CHAIR FAVRE: Thank you. 

6 MR. PEOT: Yes.

7 CHAIR FAVRE: Any questions for Chris?

8 (No response.)

9 CHAIR FAVRE: I actually have one 

10 before you go.

11 MR. PEOT: Sure.

12 CHAIR FAVRE: I have some experience in 

13 this area, and I'm curious as to how you would 

14 ensure that the biosolids would not contain, for 

15 instance, like pharmaceutical residues and things 

16 like that. I mean, are those removed during the 

17 digestion process, or what happens?

18 MR. PEOT: Yes, some are, but many 

19 aren't. They do show up. We're testing for many 

20 compounds beyond what is required by EPA because 

21 we want to make sure that we're not doing any harm 

22 to the environment either. 
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1 They do show up. And there's been some 

2 risk studies and some studies showing that. King 

3 County, Washington, where Seattle is, just did a 

4 large study, and they tested for a whole suite of 

5 compounds and pharmaceuticals, and they had four 

6 risk pathways -- a child that plays in a yard in 

7 a garden and eats a certain amount every day, a 

8 gardener, somebody who works in the forest, and 

9 somebody who works in agriculture. 

10 And they chose the most -- the pathway 

11 that was -- that gave the most -- the highest risk. 

12 And in every case there were -- they went through 

13 this whole suite of compounds. And in many cases 

14 it takes for daily exposure something like 90,000 

15 years to get a single therapeutic dose of say 

16 estrogen. So I'm not saying that they're not 

17 there. It's just the risk is extremely low. And 

18 some biosolids are better than others. So I 

19 wouldn't say take the rule out or change the rule 

20 for all, but have some sort of a science-based 

21 solution.

22 CHAIR FAVRE: Thank you.
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1 MR. PEOT: Yes, thank you.

2 CHAIR FAVRE: Okay. Next up is Liana 

3 Hoodes, and followed by Emily Lyons on deck.

4 MS. HOODES: Good afternoon, NOSB. My 

5 name is Liana Hoodes, and today I'm representing 

6 the Northeast Organic Farming Association of New 

7 York. I want to thank you all for all of the work 

8 that you do. It's incredible over the vast array 

9 of topics.

10 Founded in 1983, NOFA New York is the 

11 premier statewide organization growing organic and 

12 sustainable food in agriculture in New York State. 

13 We're an education organization for farmers and 

14 consumers. We're a USDA-accredited certifier and 

15 we also work to advocate for policies, both 

16 statewide and federal to support sustainable and 

17 organic agriculture.

18 NOFA New York is currently working in 

19 collaboration with several groups -- including 

20 Food & Water Watch, Center for Food Safety and 

21 Consumers Union -- to stop the first worldwide 

22 open-air trials of the genetically-engineered 
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1 Diamondback moth, or GDM. These trials have been 

2 permitted by APHIS to be released in an experiment 

3 station in Upstate New York, although we have 

4 recently heard that they may have been -- not 

5 followed the full law and maybe pulled back. But 

6 they're scheduled to start this year.

7 I'm going to limit my comments to two 

8 areas on your excluded method definition. I think 

9 you have covered it, but the definition must 

10 include techniques applicable to insects and 

11 animals. And I also ask that the entire organic 

12 community -- USDA, NOP and this Board -- must begin 

13 to address the issue of what contamination means 

14 and how that line gets drawn, because it's getting 

15 different out there. 

16 Diamondback moths are a serious pest to 

17 Brassica family crops around the world, mostly in 

18 southern climes, not particularly in New York 

19 State. The GDM are created using several GE 

20 techniques, including transposons and some RNA 

21 techniques. I've attached in the email version 

22 work by GeneWatch UK that has a chart of the genetic 
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1 techniques. And you should also ask questions 

2 about that of Dr. Hansen, who's also an 

3 entomologist as well as an expert on GE. In 

4 general, it will be crucial that your definition 

5 include these range of techniques.

6 The role of the GDM, genetically7 engineered Diamondback moth, is to reduce or wipe 

8 out populations of the Diamondback moths through 

9 a female lethality trait, not sterility. This 

10 trait is produced in the lab and turned off by a 

11 tetracycline switch. Multiple thousands of male 

12 GDM are repeatedly released into the field and mate 

13 with wild females who produce eggs which are laid 

14 on the Brassica. Larvae develop on the Brassica 

15 and the GDM female larvae die. The GDM male pupate 

16 to continue the cycle, surviving GDM males along 

17 with repeated additional releases of the GDM males, 

18 suppress the numbers of wild Diamondback moths 

19 through continual mating.

20 Genetically-engineered male moths are 

21 released in the field 10 to 50 times the numbers 

22 found in nature. There have been no environmental 
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1 or health impact assessments about this, and 

2 imagine GDM genetically-engineered insects on your 

3 broccoli, cabbage and cauliflower. And remember 

4 that that would not affect the organic 

5 certification because the farmer would not have 

6 used it, but they would still be on the plant. 

7 CHAIR FAVRE: Thank you. Any 

8 questions for Liana? Zea?

9 MEMBER SONNABEND: Thank you, Liana. 

10 What is it we can do that would help this situation?

11 MS. HOODES: Two things: One is do 

12 make sure with your Technical Committee, which 

13 would not be me, that you have covered all of the 

14 types of technologies that are currently being used 

15 to develop genetically engineered insects. 

16 And the other is to realize that the 

17 issue of what's considered contamination will come 

18 up. As these pest types of genetically engineered 

19 insects that are supposed to wipe out whole species 

20 of pests come up, consumers will then be hearing 

21 about and eating genetically engineered insects. 

22 And I don't even know how to approach 
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1 that in terms of what we do. I don't -- farmers 

2 should not be made -- penalized by having them fly 

3 onto their crops, but so I'm not proposing that. 

4 I'm saying we have to think about what those next 

5 steps are beyond where we are at this point. 

6 Thanks.

7 CHAIR FAVRE: Thank you. 

8 Next up is Emily Lyons, and we've got 

9 Sam Welsch on deck.

10 MS. LYONS: Good afternoon. My name 

11 is Emily Lyons and I am here on behalf of the 

12 International Dairy Foods Association. IDFA 

13 represents the dairy manufacturing and marketing 

14 industry and their suppliers, including several 

15 dairy product companies.

16 I appreciate the opportunity to comment 

17 this afternoon on the National Organic Standards 

18 Board's sunset review for several food handling 

19 substances.

20 In general, IDFA supports the Board's 

21 renewal of the substances up for review on the 

22 National List. Specifically, IDFA supports the 
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1 renewal of agar-agar, carrageenan, glucono 

2 lactone, cellulose and silicon dioxide, as all of 

3 these substances are currently used in various 

4 organic dairy products, and there are no or limited 

5 substitutes for these additives. Today my 

6 comments will specifically focus on two 

7 substances: carrageenan and cellulose.

8 Concerning carrageenan, it is used in 

9 organic dairy products because it provides a 

10 precise adjustment of texture and mouth feel in a 

11 broad range of milk and dairy products. 

12 Carrageenan interacts well with milk proteins as 

13 it promotes the smooth and thorough dispersion of 

14 even the most delicate ingredients in milk and 

15 dairy products, and it's especially useful in the 

16 formulation of low-fat versions of dairy products 

17 that can play a critical role in improving the 

18 health of the American public. As such, 

19 carrageenan is still used in some organic products 

20 due to its unique characteristics.

21 The Food and Drug Administration, the 

22 U.S. food safety authority, has approved 
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1 carrageenan as a safe food additive. The FDA has 

2 reviewed the safety of carrageenan on several 

3 occasions over the past decades, including a recent 

4 review in 2012 in response to a citizen petition. 

5 After appropriate consideration, the FDA concluded 

6 that the scientific information provided in the 

7 petition did not support the request to revoke the 

8 permitted use of carrageenan as a food additive. 

9 IDFA has worked closely with the FDA on numerous 

10 food safety and food defense issues, and we have 

11 the utmost respect their science-based 

12 conclusions. 

13 The Board should continue to recognize 

14 as it has in the past the FDA's authority and defer 

15 to its opinion on the safety of food additives, as 

16 the Board is also required to consult with the 

17 Secretary of Health and Human Services when 

18 reviewing items for listing on the National List.

19 Further, other health organizations 

20 such as the Joint Food and Agriculture Organization 

21 and the World Health Organization's Expert 

22 Committee on Food Additives and other world 
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1 regulatory agencies have recognized the safety of 

2 carrageenan.

3 Now turning to cellulose, IDFA supports 

4 the continued use of cellulose as a safe anticaking 

5 agent for organic products. And this use is also 

6 permitted by the FDA for use in certain foods such 

7 as an optional ingredient for grated cheese. 

8 Although there's no specific limit for the amount 

9 of anticaking agents listed in the grated cheese 

10 standard, it's permitted to be used up to the amount 

11 needed to achieve the technical and functional 

12 anticaking effect.

13 The limited use that is currently 

14 allowed by the Board should be continued. And I 

15 appreciate the opportunity to provide these 

16 comments to the Board. Thank you.

17 CHAIR FAVRE: Thank you.

18 Tom, you had a question?

19 VICE CHAIR CHAPMAN: Yes, you made a 

20 comment about the NOSB must and should, or 

21 something along those lines, accept the FDA's 

22 recommendation on food substances. The current 
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1 National List for handlers is something around 79 

2 materials, give or take a few, and everything added 

3 to food is over 3,000. So are you saying that we 

4 should have a list of every -- all 3,000 items?

5 MS. LYONS: No, what I'm saying is that 

6 on the substances that the National Organic Program 

7 does include on the National List, when it's 

8 reviewing things like food additives, OFPA itself 

9 states that the Secretary of Agriculture through 

10 the National Organic Standards Board must consult 

11 with the Secretary of Health and Human Services 

12 when considering items to be listed. So it could 

13 be -- that consultation should just be limited to 

14 the items that the Board decides to review. 

15 CHAIR FAVRE: Harold?

16 MEMBER AUSTIN: In regards with your 

17 support of cellulose, have there been any other 

18 alternatives that have looked at to -- that would 

19 work in the same capacity and have they been 

20 successful or not?

21 MS. LYONS: We are not aware of any 

22 other anticaking agents that organic companies 
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1 have necessarily been using in place of cellulose. 

2 I'm sure that they have looked into it in order to 

3 not use cellulose; however, at this time an 

4 appropriate replacement has not been identified.

5 CHAIR FAVRE: Tom?

6 VICE CHAIR CHAPMAN: You mentioned 

7 GDLs used in dairy. Do you know the application 

8 in dairy?

9 MS. LYONS: I believe it's used in some 

10 creams.

11 VICE CHAIR CHAPMAN: Okay. 

12 MS. LYONS: But fluid products, 

13 generally.

14 CHAIR FAVRE: Okay. Thank you very 

15 much.

16 MS. LYONS: Thank you.

17 CHAIR FAVRE: Next up is Sam Welsch, 

18 followed by Holli Cederholm.

19 MR. WELSCH: Hello. Thank you all of 

20 you for your service. 

21 I want to talk today about the organic 

22 label. It has value because it represents a 
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1 meaningful distinction from non-organic products; 

2 however, there are those who want to expand the 

3 organic label to include methods, products and 

4 ingredients that reduce this distinction to the 

5 point of being meaningless. As members of the 

6 NOSB, you're the protectors of organic integrity. 

7 Please guard it wisely. 

8 I want to discuss three significant 

9 issues today that could severely damage organic 

10 integrity. Others have already spoke about the 

11 USDA allowing operations to be certified, 

12 hydroponic operations to be certified. Organic 

13 agriculture has its roots in the soil. 

14 Certification of hydroponic dilutes and blurs this 

15 essential core feature of organic farming.

16 Number two, turning sunset rule upside 

17 down. A substance on the National List should 

18 sunset if it does not continue to have the same 

19 two-thirds majority support that placed it there. 

20 If upon review the NOSB believes that a substance 

21 continues to meet the criteria for an exemption or 

22 prohibition, the NOSB can recommend that by a 
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1 decisive two-thirds vote to renew the substance. 

2 Just change that one word in your motions and you'll 

3 return -- restore the original intent and practice 

4 of sunset review.

5 Three, the certification of substances 

6 that are non-agricultural and/or synthetic. 

7 There are non-agricultural and synthetic 

8 substances that are prohibited for use as

9 ingredients in organic products. That's a big 

10 part of why you're here. With that, however, some 

11 of these -- the synthetics -- excuse me, I'm --

12 synthetic -- or the non-ag and synthetic substances 

13 that are prohibited for use as ingredients are 

14 being certified organic. With that organic 

15 certification, these otherwise prohibited 

16 substances are being allowed as ingredients in 

17 organic products. So it's not possible to be 

18 rationally consistent when conducting organic 

19 certification if a substance can be both prohibited 

20 and certified.

21 A couple of examples, since I may run 

22 out of time, is ethyl propionate, ethyl palate, 
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1 sucrose cocoate, coconut sucrose esters, 

2 cocoglycerides, triethyl citrate. These are all 

3 items that you can find on the Organic INTEGRITY 

4 Database as certified organic products. If 

5 somebody wanted to use non-organic versions of 

6 those substances, it would not be allowed, yet 

7 somehow they're being certified.

8 If you look at the OFPA and NOP 

9 regulations, they clearly state that organic 

10 certification applies to agricultural products. 

11 I guess I'll need to stop there.

12 CHAIR FAVRE: Thank you. Any 

13 questions for Sam?

14 (No response.)

15 CHAIR FAVRE: Thank you very much.

16 MR. WELSCH: Sure.

17 CHAIR FAVRE: Next up is Holli 

18 Cederholm, and we've got Lee Frankel on deck.

19 MS. CEDERHOLM: Good afternoon. My 

20 name is Holli Cederholm, and I am the general 

21 manager of OSGATA -- the Organic Seed Growers and 

22 Trade Association. We are the farmer-controlled 
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1 national non-profit membership trade organization 

2 comprised of certified organic farmers, certified 

3 organic seed companies, organic seed professionals 

4 and organizations and individuals dedicated to the 

5 advancement of certified organic seed.

6 I would like to briefly touch on several 

7 of our issues that we've submitted extensive 

8 comments on on behalf of OSGATA's membership.

9 To begin, the National Organic 

10 Standards Board should table any further changes 

11 to the sunset process at this time, as the Federal 

12 Register notice was a rule issued without notice 

13 and comment as is required by law. This rule is 

14 currently the subject of litigation in federal 

15 court, which OSGATA is a plaintiff in. 

16 Additionally, any revision to the Policy and 

17 Procedures Manual must be open to public comment 

18 and also respect OFPA's requirement that NOSB be 

19 independent and not subservient to NOP. 

20 OSGATA's members want to reiterate our 

21 second of several issues that organic production 

22 must be soil-based following the 2010 
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1 recommendations. Therefore, hydroponic systems 

2 are not compatible with NOP organic certification, 

3 and there should be an immediate moratorium. 

4 Regarding seed purity, we'd like to 

5 thank you for your continued attention. And we 

6 submitted more thorough comments, but the thing 

7 that I'd like to underscore today is that OSGATA 

8 would like to see the adoption of a non-detect 

9 threshold for all seed used in organic production. 

10 We have a member-approved policy, which 

11 we've submitted to you time and time again, that 

12 states GE contamination of organic seed 

13 constitutes irreparable harm to the organic seed 

14 industry, and crops grown from contaminated seed 

15 will ultimately yield a contaminated product. GE 

16 pollution undermines the integrity of organic 

17 seed. Any detectable level is unacceptable.

18 Importantly, the IFOAM organics, their policy 

19 that's in a working draft on GE and GMOs aligns with 

20 this position.

21 I'd like to present another policy 

22 which I've handed out a copy of. In February 2016, 
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1 by unanimous vote of our membership, we passed a 

2 policy outlining in lay language four principles 

3 of organic plant breeding. We believe these 

4 principles establish a guiding framework which 

5 ensures the integrity of organic systems and should 

6 be used for determination of allowable breeding 

7 techniques in organic production. 

8 Briefly, number one, respects plant 

9 integrity and is free of genetic manipulation at 

10 the sub-cellular level. 

11 Number two, supports genetic diversity 

12 and opposes systems of crop monoculture. 

13 Number three, remains farm-centered 

14 and that organic plant breeding must be able to be 

15 performed on a farm.

16 And number four, honors the public 

17 domain. The genetics are part of the commons and 

18 must remain accessible to farmers and plant 

19 breeders. Utility patents have no place in 

20 organic. Thank you. 

21 CHAIR FAVRE: Tom?

22 VICE CHAIR CHAPMAN: In speaking to the 
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1 PPM, you spoke about OFPA and independence. Can 

2 you give me a citation for that?

3 MS. CEDERHOLM: Well, so, one thing is 

4 we don't really want to speak further to that as 

5 a plaintiff. In the coalition challenge of USDA, 

6 we basically were guided not to give further 

7 comment, so I think I could prepare something, but 

8 I'd want to consult.

9 VICE CHAIR CHAPMAN: So you're okay 

10 with commenting to us that OFPA requires 

11 independence, but you won't give me a citation for 

12 where OFPA says that now?

13 MS. CEDERHOLM: No, can speak with you 

14 afterwards, but as --

15 MR. GERRITSEN: I can speak to that, 

16 Tom, as president.

17 VICE CHAIR CHAPMAN: I'll speak to you 

18 guys afterwards. I mean, there's procedure for 

19 that, but I want to hear you guys' comments. So 

20 at the next break I'll come and find you guys. 

21 Thank you.

22 MS. CEDERHOLM: So, and, Tom, I'd like 
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1 to also address your comment that you brought to 

2 Jim earlier stating that OSGATA was the only 

3 organization that was against the efficient 

4 workload reorganization. I think that was a 

5 misinterpretation of our written comments. We 

6 actually didn't state that anywhere. I have a copy 

7 of what we've submitted. So --

8 VICE CHAIR CHAPMAN: Yes, the subject 

9 line says, "Sunset Reorganization?"

10 MS. CEDERHOLM: Yes, so that's why I'm 

11 saying it's a misinterpretation.

12 VICE CHAIR CHAPMAN: You meant the PPM, 

13 right, that section?

14 MS. CEDERHOLM: Yes.

15 VICE CHAIR CHAPMAN: Yes. Thank you.

16 CHAIR FAVRE: Any other questions? 

17 (No response.)

18 CHAIR FAVRE: Thank you very much. 

19 Next up is Lee Frankel, with Brett Jurd on deck.

20 MR. FRANKEL: Okay. Thanks. Good 

21 afternoon. My name is Lee Frankel, and I'm the 

22 executive director for the Coalition for 
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1 Sustainable Organics. The coalition is a group of 

2 environmentally and socially responsible growers 

3 of all sizes committed to maintaining the USDA's 

4 current high standards for certifying organic 

5 produce. Further, we believe in organics for 

6 everyone.

7 Over the past few weeks, I've met with 

8 and spoken with growers from all over the country. 

9 They have told me that containers are a critical 

10 tool that helps them best meet their site-specific 

11 conditions to foster the cycling of resources, 

12 promote ecological balance and conserve 

13 biodiversity as required by the organic 

14 regulations. I've also learned that most organic 

15 container operations are small family businesses. 

16 To me, they are the very embodiment of the public 

17 priority of the USDA to bring new and small farmers 

18 into the industry.

19 Now, I'd like you to imagine a 

20 Government program established with the purpose of 

21 reducing greenhouse emissions for people commuting 

22 to work. Members of the public are quickly excited 
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1 by the potential to impact the world through their 

2 individual choices and begin to participate. Some 

3 people carpool; some people take public 

4 transportation; some buy a hybrid car, while others 

5 ride their bicycle to work. Some people even use 

6 a combination of the different methods depending 

7 on the weather or their schedule for the day. Now, 

8 imagine that a group of car companies comes in to 

9 say that riding a bicycle should not count since 

10 it doesn't have a mechanical motor. That just 

11 would not make sense. 

12 Year after year, the Organic Trade 

13 Association Survey of the primary consumer 

14 motivations for purchasing USDA organic product 

15 show that consumers are looking to avoid pesticides 

16 in their fresh produce and to avoid added hormones 

17 and antibiotics in their meat products. Thus, for 

18 the vast majority of consumers produce grown in 

19 containers following USDA standards is every bit 

20 as organic as produce grown in the ground. 

21 Let me make this clear: containerized 

22 organic growers rely on the same natural inputs and 
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1 biological processes as open-field growers to 

2 nourish and grow their crops while using methods 

3 that have been in use for thousands of years. At 

4 a time when demand for organic produce is at an 

5 all-time high, changing U.S. organic growing 

6 standards to restrict containerized growing will 

7 limit the amount of organic produce available to 

8 consumers, making it less accessible and more 

9 expensive for those who want it. If a grower meets 

10 USDA standards for organic certification, their 

11 produce is organic, whether grown in the outer 

12 crust of the earth or other sustainable organic 

13 growing medium. 

14 The members of the coalition admire the 

15 hard work and commitment of the members of the task 

16 force and the NOSB. We look forward to supporting 

17 you as you consider this issue moving forward. 

18 CHAIR FAVRE: Thank you. Emily.

19 MEMBER OAKLEY: Thank you. I was 

20 wondering if you have a study that indicates that 

21 consumers are aware of hydroponics versus 

22 soil-grown organic systems, when you make the 
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1 statement that consumers just want organic? 

2 Because I -- that was stated earlier, and I'm 

3 wondering if there's a study that that's being

4 referred to?

5 MR. FRANKEL: It's a study of Organic 

6 Trade Association's Organic Attitudes and Belief, 

7 and they don't ask the question specifically, 

8 hydroponics or growing methods.

9 This is an open-ended question that 

10 they ask to consumers. What really matters to you? 

11 And this is what they come back with, are 20 

12 different items and not one of them includes 

13 whether it was hydroponic or grown in the soil.

14 CHAIR FAVRE: Any other questions. 

15 Thank you very much.

16 MR. FRANKEL: Thank you.

17 CHAIR FAVRE: Next up is Brett Jurd. 

18 We've got Daniel Fabricant on deck.

19 MR. JURD: Good afternoon. My name is 

20 Brett Jurd, and I'm here representing the Synthetic 

21 Amorphous Silica and Silicate Industry 

22 Association.
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1 On behalf of SASSI, I'd like to thank 

2 you for giving us the opportunity to comment on the 

3 sunset review of silicon dioxide. SASSI would 

4 like to request that silicon dioxide remain on the 

5 list of allowable substances.

6 Based on a review by a number of our 

7 member companies reported to NOSB, and our comment 

8 letters dated November 11th, 2011, December 20th, 

9 2013, and April 7, 2015, coupled with recent 

10 experiences reported to us by food processors, 

11 silicon dioxide remains an essential and 

12 irreplaceable ingredient in a broad number of 

13 applications, including, but not limited to, free 

14 flow agents and as an anticaking agent.

15 As you're likely aware, silicon dioxide 

16 has been safely and successfully employed for more 

17 than 70 years in the food industry. Critical for 

18 consideration is the safety of silicon dioxide. 

19 It has been extensively studied and has broad 

20 regulatory approval, both here in the U.S. and 

21 overseas where U.S. manufactured organic products 

22 may be sold.
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1 Decades of improvement to silicon 

2 dioxide have resulted in a substance of extremely 

3 high purity and exceptional performance and 

4 consistent quality.

5 These facts allow the organic industry 

6 to use silicon dioxide with the confidence needed 

7 in organic food industry to consistently supply 

8 high-quality products.

9 While we do acknowledge that there may 

10 be specific limited applications where silicon 

11 dioxide -- excuse me, limited applications were 

12 currently available alternatives to silicon 

13 dioxide may provide acceptable performance, 

14 SASSI's members are confident that they cannot be

15 used as a viable replacement for all silicon 

16 dioxide and all the applications where it is 

17 currently employed.

18 Given its broad range of applications, 

19 silicon dioxide would have -- the de-listing of 

20 silicon dioxide would have a significant adverse 

21 effect on the organic food producer's ability 

22 provide acceptable products to the consumer.
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1 For the above reasons, we therefore 

2 feel that it is imperative that silicon dioxide 

3 remain on the list of allowable ingredients. 

4 Thank you.

5 CHAIR FAVRE: Thank you. Any 

6 questions? Lisa.

7 MEMBER DE LIMA: So you briefly 

8 mentioned that there were some uses where 

9 alternatives were viable, just not all uses. 

10 Could you speak some more to the specifics of where 

11 alternatives do work?

12 MR. JURD: The -- I'm not -- I believe 

13 defoaming with a Ryzolt product. That's the only 

14 one that I'm familiar with.

15 CHAIR FAVRE: Harold.

16 MEMBER AUSTIN: During this last --

17 this current sunset review cycle, for the areas 

18 where you say that there's no specific alternatives 

19 that are effective, has there been work done, 

20 though, to try to look at alternatives that have 

21 not been successful?

22 MR. JURD: We're a silica producer, so 
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1 we don't really look at alternatives. I'm not sure 

2 if other people do. What -- the feedback we're 

3 getting from our customers is no. But, to be 

4 honest --

5 (Laughter.)

6 CHAIR FAVRE: Thank you very much.

7 MR. JURD: Thank you.

8 CHAIR FAVRE: Next up is Daniel 

9 Fabricant and we've got Susan Finn on deck.

10 DR. FINN: Thank you, Tracey. I'm 

11 Daniel Fabricant, the Executive Director and CEO 

12 with the Natural Products Association, the oldest 

13 and largest trade association representing sellers 

14 and manufacturers of natural and organic products 

15 in this country. Thank you for your time today.

16 Consistent with our written comments, 

17 we urge this Board to really weigh the evaluation 

18 of carrageenan strictly on the scientific 

19 evidence, which has been evaluated by the world's 

20 experts many times over. Those experts include 

21 the ultimate food authority here in the U.S., the 

22 FDA, the FSA, WHO, JECFA, and many others.
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1 At this time, carrageenan has been 

2 repeatedly shown to be safe for consumption of both 

3 organic foods and organic infant formula. 

4 Carrageenan is in many food products and consumer 

5 goods as a thickener, emulsifier, stabilizer, and 

6 gelling agent.

7 In addition to its long history of safe 

8 use, it is allowed by FDA as a direct food additive 

9 and a grass substance. During my time as a 

10 Division Director at the FDA, there was never a 

11 rendering that carrageenan presented unreasonable 

12 risk of illness or injury, or any other harm to be 

13 rendered adulterated.

14 In addition, USDA's AMS conducted an 

15 independent review, which included consultation 

16 with experts from FDA, to gain a detailed 

17 understanding of the regs allowing for safe use of 

18 carrageenan in infant formula and foods.

19 In that review, FDA continued to 

20 maintain that carrageenan is safe for use in food 

21 and infant formula. The last time there was a 

22 public hearing inquiry into carrageenan, the NOSB 
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1 recommended that carrageenan be excluded from 

2 organic infant formulas. However, a prior May 

3 2012 NOSB meeting the Handling Subcommittee USDA 

4 reiterated that carrageenan was compatible with 

5 organic production practices and does not reveal 

6 an unacceptable risk to the environment, human, or 

7 animal health. A 2013 opinion from USDA in a 

8 proposed rule, once again, upheld that opinion.

9 While we understand the NOSB has a broad 

10 mandate, the larger focus is deemed whether or not 

11 a material is appropriate for use in organic 

12 products, not establish themselves as a 

13 toxicological evaluation body, such bodies already 

14 exist.

15 Consistent with that theme and other 

16 regulatory agencies, a 2003 opinion of JECFA, which 

17 has met no less than seven times on safety, has 

18 never prohibited its use.

19 Speaking -- in closing, any regulators 

20 who would not consider the totality of the science 

21 will get in real trouble as either being arbitrary 

22 or capricious, so again, I implore this Board to 
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1 look at the science, and also, FDA has rendered an 

2 opinion many times that the ingredient is perfectly 

3 safe.

4 In addition to that rendering, we'll be 

5 requesting that they formally put it to their 

6 external advisory committee to no longer hold the 

7 science hostage. So with that, thank you for your 

8 time.

9 CHAIR FAVRE: Any questions for 

10 Daniel? Thank you very much. 

11 Next up is Susan Finn, and we've got 

12 Margaret Barnes on deck.

13 DR. FINN: Thank you very much for the 

14 opportunity to speak with you here today, and I 

15 value you what you do to make healthy choice foods 

16 available to people.

17 I am Susan Finn. I am a PhD Registered 

18 Dietician Nutritionist. I am speaking here on 

19 behalf of the United 4 Food Science where I am the 

20 Director.

21 We are a coalition of scientists, 

22 academics, nutritionists, toxicologists, experts 
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1 in agriculture and food production, and we are all 

2 dedicated to ensuring that unbiased science 

3 remains the foundation of Washington's decision 

4 making process.

5 Over my 40-year career, including 

6 leadership in the Academy of Nutrition and 

7 Dietetics, the largest nutrition organization in 

8 the world, I have championed the necessity of 

9 basing our nation's food and nutrition policy on 

10 sound science.

11 Today's topic is the organic status of 

12 carrageenan but the fundamental question here at 

13 the table is, will the guiding principles of this 

14 country's food and nutrition policy be based on 

15 facts and sound data, or will it acquiesce to loud 

16 voices, anxiety-creating tactics and questionable 

17 research?

18 Carrageenan is the case in point here, 

19 of course. Although long approved by the USDA for 

20 its use in organic foods, a vocal opposition is 

21 questioning its safety. However, extensive data 

22 based on centuries of use and decades of studies 
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1 lead to these conclusions. Carrageenan is not 

2 even only safe, effective, and economic, it's 

3 essential.

4 It's essential to the ground-breaking 

5 innovations in food science that help make our 

6 diets healthier, and healthier foods. For 

7 example, to combat obesity major food companies 

8 have literally eliminated trillions of calories 

9 from the food supply by reducing fat, salt, and 

10 sugar. Thanks to carrageenan, these ingredients 

11 can be removed without compromising texture and 

12 consistency and customers have become accustomed 

13 to that.

14 Second, carrageenan is essential to the 

15 nutritional value of some of our most critical 

16 products, infant formula, medical nutrition 

17 products, carrageenan's emulsifying stabilizing 

18 properties ensures a palatable taste and texture, 

19 meaning infants and patients receive balanced 

20 packet of nutrients from that first sip to that last 

21 drop. Unlike other substitutes, carrageenan 

22 accomplishes this without altering taste and 
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1 color.

2 And third, carrageenan is essential to

3 the fight against food and nutrition insecurity. 

4 Carrageenan's properties give canned foods, often 

5 stored in food banks and transported long distance, 

6 a stable, long shelf life, without compromising 

7 health, cost, or safety.

8 So these facts are based on decades of 

9 proven research and good evidence. This is the 

10 quality of science that nutrition experts around 

11 the world rely on to make decisions. I hope you, 

12 too, rely on sound science when you make your 

13 decisions regarding carrageenan. Thank you.

14 CHAIR FAVRE: I'm guessing you must 

15 have practiced that a time to two.

16 DR. FINN: No I didn't.

17 CHAIR FAVRE: Zea, you had a question?

18 MEMBER SONNABEND: Yes. Thank you for 

19 your comments, and I'm sorry to have to ask you this 

20 question, but there's a lot of -- you may have read 

21 some of the other comments, or not, and there's a 

22 lot of accusations and insinuations of bias in the 
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1 various research and comment perspectives. And 

2 so, I am wondering, how your organization is funded 

3 and if you are receiving any funding from the 

4 carrageenan manufacturers?

5 DR. FINN: Ours is a coalition funded 

6 by a group of different organizations and, yes, 

7 they do support other coalition's activities. 

8 And, of course, the research we pulled together 

9 based on sound science from many, many decades of 

10 research.

11 MEMBER SONNABEND: And, not just on 

12 carrageenan, on other nutritional subjects?

13 DR. FINN: We look across the board but 

14 primarily right now, we're, of course, focusing on 

15 carrageenan.

16 MEMBER SONNABEND: Okay.

17 CHAIR FAVRE: Harold.

18 MEMBER AUSTIN: Could you, in your 

19 opinion, give us your thoughts or input on the level 

20 of scientific expertise that guides JECFA and the 

21 WHO and their recent releases on the information 

22 regarding carrageenan?
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1 DR. FINN: Again, I'm not the world's 

2 expert on that committee's recommendation. Some 

3 of the scientists would probably give you -- that 

4 you heard in the webinar, may give you even more, 

5 but World Health Organization and Joint Expert 

6 Committee on Additives have long approved 

7 carrageenan for use.

8 We have a long, long history of a lot 

9 of the research on products, such as infant 

10 formula, have a long -- decades and decades of 

11 history on it.

12 CHAIR FAVRE: I had one quick question 

13 for you.

14 DR. FINN: Sure.

15 CHAIR FAVRE: You mentioned that the 

16 properties of carrageenan used, for instance, in 

17 infant formula ensured the nutritional quality.

18 DR. FINN: Right.

19 CHAIR FAVRE: Can you speak to that a 

20 little bit?

21 DR. FINN: Yes. Both infant nutrition 

22 -- infant formulas as well as medical nutrition 
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1 products that are used primarily orally by 

2 patients, like cancer patients, would be an example 

3 of that patient.

4 When you have a product that's stable, 

5 that it's emulsified, that infant, or that patient, 

6 is getting a complete of nutrients at swallow. 

7 It's not separated. It's all together in a stable 

8 emulsion. And for that reason, they're getting 

9 all the nutrients, no matter how much of that 

10 product they drink.

11 They may not finish the whole cup, or 

12 the whole glass, or the whole bottle, but they're 

13 still getting the maximum nutrients in that volume.

14 CHAIR FAVRE: Just as a follow up to 

15 that, we've seen in some of the public comments that 

16 without carrageenan a consumer would basically 

17 just have to shake the product repeatedly and is 

18 there any reason why that couldn't be done?

19 DR. FINN: Not acceptable. It's 

20 nothing, I think, that people would want to do, but 

21 yes. But it would hold in solution. It would fall 

22 apart very quickly.
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1 CHAIR FAVRE: Thank you. Any other 

2 questions for her? Thank you very much. Thank 

3 you for your excellent timing today, too. 

4 Next up is Margaret Barnes, followed by 

5 Charlotte Vallaeys.

6 MS. BARNES: Hello. I hope I'm as 

7 short as she is but I don't think I will be. My 

8 name is Margaret Barnes. I'm with Moms Across 

9 America and I co-founded the Moms Across America 

10 in Maryland, and I founded the Moms Across America 

11 at Eastern Shore.

12 I have a testimonial I'd like to read, 

13 but I first would like to say that on my way here 

14 from the Eastern Shore, I passed several fields 

15 that were just completely red and the reason 

16 they're red is because they're cover crops, and 

17 they were saturated in Roundup and Atrazine to 

18 destroy the cover crops because, obviously, the 

19 farmers no longer want to till them and it's just 

20 -- dealing with the poultry industry on the Eastern 

21 Shore has been something that's been all consuming 

22 lately. They're expanding rapidly.
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1 And it's a huge concern for me, as a 

2 parent, but also in terms of organic food, 

3 particularly, manure, fertilizer, any manure 

4 fertilizer that is coming from factory farms has 

5 to be held to a higher standard than it is.

6 I know that the lady before me was 

7 talking about infant formula and of course, you 

8 know, they -- arsenic has been found not only in 

9 conventional formula but also organic, and a lot 

10 of that has to do with the arsenic that was 

11 deliberately fed to chickens as part of the feed.

12 So this is something that concerns me 

13 a lot is -- frankly, it's the one that frightens 

14 me more than anything when it comes to keeping our 

15 organic food organic.

16 So anyway, dear -- and if I run too long 

17 please cut me off. Dear distinguished NOSB Board 

18 Directors, thank you for the opportunity to address 

19 the Board. I appreciate what you do to protect the 

20 standards for organic food, particularly as a 

21 mother, because our children are exposed to more 

22 chemicals, pesticides, herbicides, and heavy 
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1 metals than at any other time in history.

2 We are facing a health crisis in America 

3 and we need you to be vigilant more than ever to 

4 protect our children in a fight for a sustainable 

5 future.

6 The present day reality of our health 

7 is shocking. According to Steve Wolf of the 2014 

8 U.S. World Health Report, of the top 17 most 

9 developed countries, the USA is last in health. In 

10 a 2014 Save the Children Report, of the top 

11 developed countries -- oh, oops. I didn't get to 

12 read this.

13 This is mainly about glyphosate, and 

14 how it's being found pretty much in everything now. 

15 And it's being so liberally used that it's almost, 

16 you know, not even regarded as something dangerous. 

17 Though, anyway, that's what I have. But if you 

18 would like to know about chicken CAFOs on the 

19 eastern shore, I can tell you about that.

20 CHAIR FAVRE: Do we have any questions 

21 for Margaret? Thank you very much.

22 MS. BARNES: Thank you.
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1 CHAIR FAVRE: Next up is Charlotte 

2 Vallaeys, and followed by Kip Rondy.

3 MS. VALLAEYS: Good afternoon. My 

4 name is Charlotte Vallaeys and I'm a Senior Policy 

5 Analyst with Consumer Reports Food Safety and 

6 Sustainability Center.

7 The value of the organic label lies in 

8 the strength of the organic law and regulations, 

9 which promise consumers a consistent standard for 

10 organically produced foods, and create a 

11 meaningful process with strict limits for 

12 determining what can and cannot be used in organic 

13 food production.

14 Carrageenan should be removed from the 

15 National List. It does not meet the criteria in 

16 OFPA. Laboratory research in animals have shown 

17 ulcerative colitis-like disease and intestinal 

18 lesions and ulcerations in some animals.

19 Additional studies in animals have 

20 shown carrageenan may act as a promoter of colon 

21 tumors. Recent research suggests that 

22 carrageenan may also contribute to the development 
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1 of Type II Diabetes.

2 The NOSB should use the precautionary 

3 principle. The burden of proof, given this 

4 existing scientific literature, should not fall on 

5 consumers. 

6 We believe NOSB should consider the 

7 difference between materials that are necessary to 

8 the production of an organic product, like yeast 

9 in bread, and materials that are just convenient 

10 or useful. Our 2016 Consumer Survey shows that 70 

11 percent of consumers do not think that non-organic 

12 ingredients should be added to organic foods if 

13 they are not deemed essential.

14 We do not believe there's currently any 

15 organic product on the market that could not be made 

16 without carrageenan. It is therefore, not 

17 essential. 

18 We oppose listing oat beta-glucan for 

19 the same reason. It fails the OFPA criteria of 

20 essentiality.

21 For SDBS, the NOSB should not vote to 

22 list it on the National List without a TR. For 
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1 ancillary substances, the NOSB should review all 

2 ingredients that end up in organic foods to OFPA 

3 criteria.

4 Our 2016 survey found that 91 percent 

5 of consumers think artificial materials or 

6 chemicals should not be used during processing of 

7 organic foods, and 89 percent of consumers think 

8 that the organic label on processed and packaged 

9 foods should mean no artificial ingredients or 

10 colors were used.

11 We continue to urge the NOSB to review 

12 all materials, including ingredients of 

13 ingredients used in organic production, to OFPA 

14 criteria, to determine whether they are not harmful 

15 to human health and the environments, whether they 

16 are essential, and compatible with organic 

17 production.

18 For nutrient vitamins and minerals, we 

19 propose listing vitamins and minerals as a category 

20 on both 205.605(a) and (b), with individual 

21 vitamins and minerals listed underneath after they 

22 have undergone full review by the NOSB to OFPA 
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1 criteria.

2 Many sources of vitamins and minerals 

3 already appear individually on the National List, 

4 such as iron, Vitamin C, and only a handful, 

5 including Vitamin A and Vitamin D, would need to 

6 be petitioned. Thank you.

7 CHAIR FAVRE: All right, thank you. 

8 Jane, you had a question? Followed by Tom.

9 MEMBER RICHARDSON: Charlotte, did 

10 Consumer Reports any work in regards the seaweed 

11 sources of carrageenan and their over-harvesting, 

12 as part of the research on that material?

13 MS. VALLAEYS: No, we didn't do any 

14 research on that. After we reviewed the 

15 scientific literature on the human health effects, 

16 it was pretty clear to us that on that basis alone 

17 it should not be re-listed.

18 MEMBER RICHARDSON: Thank you.

19 CHAIR FAVRE: Tom.

20 VICE CHAIR CHAPMAN: You made comments 

21 about alternatives to carrageenan or that there's 

22 alternative products --
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1 MS. VALLAEYS: Oh --

2 VICE CHAIR CHAPMAN: Yes, right here. 

3 I know it's confusing the voice coming from there 

4 and there.

5 MS. VALLAEYS: Right.

6 VICE CHAIR CHAPMAN: You talked about 

7 alternative products on the marketplace that don't 

8 contain carrageenan. Most of those contained 

9 other gums and gelling gum, are those also 

10 materials that Consumer Reports opposes, or --

11 MS. VALLAEYS: Nope.

12 VICE CHAIR CHAPMAN: -- are those 

13 alternatives --

14 MS. VALLAEYS: No you'll have no --

15 VICE CHAIR CHAPMAN: -- acceptable?

16 MS. VALLAEYS: I'm sorry. Yes, you 

17 notice for agar-agar, gellan gums, some of the 

18 alternatives to carrageenan, we have not submitted 

19 comments opposing the re-listing of those. And we 

20 have done a search of the scientific literature on 

21 human health effects of those gums, and unlike 

22 carrageenan, we do not object to the human health
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1 effects -- that they don't meet the human health 

2 effects criteria in OFPA. So -- whereas 

3 carrageenan doesn't.

4 VICE CHAIR CHAPMAN: Specifically to 

5 human health, on the other criteria, do you have 

6 objections on those substances?

7 MS. VALLAEYS: Their essentiality, you 

8 mean? Yes, I mean, we still think -- and we 

9 continue to think that if something is being used 

10 because it is useful or convenient, for example, 

11 the alternative would be to put a shake well words 

12 on the label.

13 Yes, we do believe that that is an

14 alternative. Creating a certain mouth feel for a 

15 product that doesn't -- or a creamy, fatty mouth 

16 feel for a product that doesn't have cream, we don't 

17 think that that's essential. We think it doesn't 

18 meet those criteria.

19 VICE CHAIR CHAPMAN: Thank you.

20 CHAIR FAVRE: Emily.

21 MEMBER OAKLEY: You and a couple of 

22 others reported objections to the ancillary 
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1 substances proposal and I'm wondering if you could 

2 specify how each material could be reviewed 

3 individually?

4 MS. VALLAEYS: Our objection is based 

5 on OFPA which doesn't distinguish between 

6 ingredients of ingredients, so if it's an 

7 ingredient of an ingredient that's on the National 

8 List, it still ends up in an organic food and 

9 consumers do have those expectations that when they 

10 buy a food with the organic label that everything 

11 that ended up in that food, however it ends up in 

12 there, has been reviewed to OFPA criteria by the 

13 NOSB.

14 So based on that, we believe that 

15 ancillary substances should be reviewed 

16 individually to OFPA criteria to determine whether 

17 they meet human health and environmental 

18 compatibility and essentiality criteria.

19 CHAIR FAVRE: Any other questions? 

20 Thank you.

21 MS. VALLAEYS: Thank you.

22 CHAIR FAVRE: Next up is Kip Rondy, 
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1 followed by Jay Highman.

2 MR. RONDY: My name is Kip Rondy. With 

3 my wife Becky and I, along with nine or ten other 

4 year-round employees, we make up -- which is Green 

5 Edge Gardens in Athens, Ohio.

6 We are a full-time year-round vegetable 

7 farmers and are solely dependent on our farm income 

8 for many years. I'm a certified -- I've been a 

9 certified organic grower for most of my life.

10 We certify for a couple of reasons. 

11 Most was to preserve and improve the integrity of 

12 the land and the nutritional content of the food 

13 we grow. The second reason we certified is to 

14 obtain a higher price for our produce.

15 I want to talk to you about three 

16 things, integrity of the organic name, economic 

17 stability of small and medium-sized farms, and the 

18 legacy to the next generation.

19 It's on the web and in the print media 

20 that frack water is being used for irrigation in 

21 both conventional and organic food crops, mostly, 

22 at present, in California.
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1 In my county alone, that's in Athens, 

2 Ohio, we are injecting over a million gallons 

3 annually of frack waste into the Earth, supposedly 

4 never to be seen again. Well, at least not for a 

5 few years. That's a joke.

6 I am sure, if it got dry enough at home, 

7 the frack water we are currently injecting into the 

8 earth would find in agricultural use. And what do 

9 we do, the guardians of the organic name, in light 

10 of this unwanted publicity? We wring our hands, 

11 and say it's up to the EPA. What good are standards 

12 if you don't have the courage to enforce them?

13 At stake here is everything that we in 

14 organic growers have built over the last 40 years, 

15 as far as the development of a public image and the 

16 quality and integrity of the organic brand and we 

17 are willing to throw that away to satisfy a flawed 

18 bureaucracy, and dare I say, a large corporate 

19 interest.

20 And what about the economic stability 

21 of the organic spot to the small and medium-sized 

22 farms? Are we willing to trash that just after 
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1 family farms are beginning to make a comeback? Oh 

2 I know, we'll start local. That'll be a good idea. 

3 Until somebody else comes along and takes that away 

4 from us.

5 What good are standards, if we don't 

6 have the courage to enforce them? Since taking our 

7 farm over in 1984, the ground is substantially 

8 better -- in better condition than when it was when 

9 I first came to the farm. I owe much of that 

10 improvement to the influence and guidance from 

11 other conscientious farmers, both regionally and 

12 nationally.

13 In summation, I would say, what good are 

14 standards, if we don't have the courage to enforce 

15 them? Thank you.

16 CHAIR FAVRE: Any questions for Kip? 

17 MR. RONDY: Thank you.

18 CHAIR FAVRE: Thank you very much. 

19 Next up is Jay Highman, followed by Alesia Bock.

20 MR. HIGHMAN: Hello --

21 CHAIR FAVRE: And --

22 MR. HIGHMAN: -- I'm Jay Highman, and 
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1 I --

2 CHAIR FAVRE: Excuse me, just a minute.

3 MR. HIGHMAN: Sorry.

4 CHAIR FAVRE: Just as a reminder to 

5 everybody making comments, if you can make sure you 

6 can speak up, some of the board members are having 

7 a hard time hearing some folks. Just make sure you 

8 project. Thank you.

9 MR. HIGHMAN: Hi, I'm Jay Highman, 

10 President and CEO of Nature's One. I'm talking 

11 today about the need for synthetic vitamins and 

12 minerals in organic products.

13 There's three reasons for nutrition in 

14 vitamins and minerals in organic products. One is 

15 nutrition for tube and enteral fed patients, second 

16 is Centers for Medicaid and Medicare require 

17 vitamins and minerals, and also the FAO/WHO do as 

18 well.

19 First of all, let's talk about enteral 

20 nutrition. It's nourishment administered into 

21 the gastrointestinal tract, either orally or 

22 through tube feeding. Each day 500,000 children 
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1 and adults are tube-fed. There are a variety of 

2 reasons for this, childhood cancers, congenital 

3 heart defects, cleft pallet, metabolic disorders. 

4 There's over 300 medical conditions that require 

5 tube feeding nutrition.

6 Vitamins and minerals are just a 

7 necessary part of their daily lives and are very 

8 important for their livelihood and for their 

9 continuation to thrive. Synthetic vitamins and 

10 minerals are the only option for organic enteral 

11 products.

12 The second reason is Centers for 

13 Medicaid and Medicare require that vitamins and 

14 minerals be included to be classified according to 

15 what is commonly known as B Codes. This is a common 

16 procedure coding system.

17 Nature's One's formulas are registered 

18 and approved using this HCPCS 2016 Code called 

19 B4158. The FAO and WHO also require -- there's a 

20 definition for follow-up formulas and it's defined 

21 as food prepared from the milk cows or other animals 

22 and it's basically for infants six months on and/or 
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1 for young children. And, again, the CODEX 

2 standards specify that there's a minimum and 

3 maximum amount of nutrients in follow-on formulas.

4 So the three reasons, essentially, 

5 Medicare/Medicaid require it, the B4158 Codes, the 

6 CODEX requires it for toddler formulas and 

7 follow-on formulas, and enteral and tube-fed 

8 children require this for their survival.

9 I don't think that relieves us of any 

10 commitment to organic as a company. We're always 

11 pursuing organic vitamins and minerals, but as we 

12 all know that has to be proven and the efficacy has 

13 to be known.

14 So I respectfully request that the 

15 final annotation includes reference to allow 

16 synthetic vitamins and minerals for enteral 

17 products and HCPCS B Codes, and also, for formulas 

18 meeting CODEX standards for follow-on feedings. 

19 Thank you.

20 CHAIR FAVRE: Tom.

21 VICE CHAIR CHAPMAN: The formulas for 

22 follow-on feeding, is that for medical purposes or 
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1 is that for formulas for kids over the age of one?

2 MR. HIGHMAN: For both. But 

3 essentially the B codes are assigned to medical 

4 foods or medical formulas, which would be enteral 

5 tube fed.

6 VICE CHAIR CHAPMAN: And would the 

7 citation to the references that we have already 

8 cited be applicable, that list that allowed 

9 vitamins and minerals?

10 MR. HIGHMAN: No, one, two, and three 

11 do not account for enteral fed or for the CODEX 

12 standard. So that's the inclusion that we would 

13 respectfully request be included.

14 VICE CHAIR CHAPMAN: Thank you. I 

15 have one more question. So I assume you're a 

16 manufacturer of these products --

17 MR. HIGHMAN: Yes.

18 VICE CHAIR CHAPMAN: -- enteral food, 

19 organic ones, as well, I guess?

20 MR. HIGHMAN: Only organic, yes.

21 VICE CHAIR CHAPMAN: Only organic. Do 

22 you use carrageenan in any of those products?
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1 MR. HIGHMAN: Do we use carrageenan? 

2 No we do not.

3 VICE CHAIR CHAPMAN: You do not. 

4 Thank you.

5 (Laughter.)

6 MR. HIGHMAN: I got some points 

7 someplace back there for that.

8 CHAIR FAVRE: Harold.

9 MEMBER AUSTIN: Have you submitted 

10 your comments and this information with these 

11 bullet points in writing to us, or --

12 MR. HIGHMAN: We submitted a letter, 

13 yes, with all these.

14 MEMBER AUSTIN: Okay.

15 CHAIR FAVRE: So before you go, I just 

16 want to clarify. So what you're saying is that we 

17 need to add this as an annotation to the listing, 

18 in addition to the recommendations that we've 

19 already got?

20 MR. HIGHMAN: Yes.

21 CHAIR FAVRE: Okay.

22 MR. HIGHMAN: For these specific uses, 
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1 yes.

2 CHAIR FAVRE: Okay. Thank you. Any 

3 other questions?

4 All right. Thank you, Jay.

5 MR. HIGHMAN: Thank you very much.

6 CHAIR FAVRE: Next up is Alesia Bock, 

7 followed by Amalie Lipstreu.

8 MS. BOCK: Hello. My name is Alesia 

9 Bock, the Director of AgriSystems International. 

10 Thank you for the opportunity to provide feedback 

11 today. I'm here to provide client feedback on 

12 several sunset items as well as two of the petitions 

13 for handling.

14 For sunset, we support the re-listing 

15 of copper sulfate and per acetic acid, and for 

16 handling, we support the re-listing of silicon 

17 dioxide and cellulose as the anticaking agents, 

18 enzymes for cheese production and beta-carotene 

19 for naturally derived color.

20 Secondly, we support two petitions 

21 being evaluated by the Handling Committee, 

22 specifically, the sodium and potassium Lactate and 
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1 STBS as antimicrobials. And we don't take this 

2 position lightly.

3 We very much appreciate the Board for 

4 your work. You have the monumental task of 

5 evaluating all these materials against OFPA 

6 criteria, as well as taking into account many 

7 diverse stakeholder positions and needs.

8 We applaud the clear trend since 2007 

9 that has consistently reduced the number of 

10 non-organic materials on the National List by 

11 supporting time it takes to develop commercially 

12 available organic opportunities. This is how the 

13 system is designed to work.

14 However, we would request that the 

15 Board consider these two handling petitions in the 

16 broader context of food safety, to ensure that the 

17 industry has robust antimicrobials in their 

18 restricted toolbox until organic alternatives are 

19 developed and commercially available.

20 Specifically regarding potassium 

21 lactate and sodium lactate, we understand that 

22 these materials are critical antimicrobials to 
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1 reduce pathogens in organic meat products. HPP 

2 may be an option longer term, but for small 

3 producers it may not be commercially viable.

4 For SDBS, this is an active ingredient 

5 in a product specifically developed for food 

6 service applications, such as restaurants and 

7 stores, to prepare fruits and vegetables in a safe, 

8 sanitary manner.

9 Per CCOF criteria, it appears that 

10 these materials meet human health and 

11 environmental impact. These are also very unique, 

12 specific safer alternatives for food service 

13 employees that are safer to use than other 

14 currently allowed sanitizers and cleaners on the 

15 List.

16 Consumers are demanding more quality 

17 organic foods and the industry is responding. 

18 However, food safety must remain top of mind for 

19 everyone.

20 While Chipotle was the first national 

21 restaurant chain that pledged the self-sustainably 

22 raised non-GMO food, we were thrilled. But the 
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1 recent illness events have shaken consumer 

2 confidence and threatened to carry over to the 

3 organic industry, just as the bagged spinach 

4 recalls did a few years ago.

5 So as organics continue to grow, we need 

6 to make sure that robust and environmentally 

7 friendly food safety goals are available to 

8 handlers, while the industry is continued to 

9 encourage to continue developing suitable organic 

10 alternatives, especially for use in the food 

11 service industry as consumers expect organic 

12 products for on-the-go occasions. Thank you.

13 CHAIR FAVRE: Thank you. Any 

14 questions? Harold.

15 MEMBER AUSTIN: For -- as for sodium 

16 dibenzyl sulfonate, do you know what currently is 

17 being used, right now, in place of that, if 

18 anything?

19 MS. BOCK: We have attempted to find 

20 out from retailers, specifically on the questions 

21 that the Board was asking. We didn't get as much 

22 feedback on that, as we'd like. There's someone 
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1 else here who might have more information than I 

2 do on that so I'd like to defer.

3 CHAIR FAVRE: Go ahead.

4 MEMBER AUSTIN: Okay, switching gears 

5 to sodium and potassium lactate. It looks like 

6 most of the information that we're getting back is 

7 really more in support of sodium lactate, rather 

8 than potassium lactate. Can you give us any 

9 further information on that?

10 MS. BOCK: From what I understand 

11 through people that I know that are using sodium 

12 lactate, it seems to be the more common used one. 

13 We didn't hear back from anyone specifically 

14 stating that potassium lactate or sodium would be 

15 better or worse. At least I didn't get any 

16 personal feedback from that.

17 CHAIR FAVRE: Thank you very much. 

18 Okay, next up is Amalie or Amalie Lipstreu, and 

19 we've got Julia Barton on deck.

20 MS. LIPSTREU: Good afternoon. The 

21 Ohio Ecological Food and Farm Association is a 

22 grassroots coalition of over 4,000 members working 
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1 to develop a healthy and sustainable food system. 

2 Our certification program certifies over 950 

3 producers and handlers in 18 states.

4 Organic food represents something 

5 pure, something nutritive, chemical-free, an 

6 ecological system of agriculture. The nature of 

7 organic farming requires our farmers to be 

8 indigenous to place in a way that's unique in 

9 agriculture and requires mutual dependencies on a 

10 high-quality natural resource base.

11 OEFFA provided comments last fall about 

12 how unconventional oil and gas extraction is 

13 impacting organic farms and the potential for that 

14 harm to grow.

15 Since that time, the impacts of high 

16 pressure hydraulic fracturing have continued to 

17 increase, as has public awareness about the 

18 negative effects on organic farms and organic 

19 products.

20 And here's what we know. 

21 Approximately 20 percent of organic farms in the 

22 United States are in close proximity to areas of 
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1 shale gas extraction. There are no national 

2 restrictions in pace protecting organic farms from 

3 production wells, injection wells, pipeline

4 impacts, or compressor station impacts.

5 Most gas drilling and extraction is 

6 exempt from requirements of the Underground 

7 Injection Control Program of the Safe Water 

8 Drinking Act and has similar exemptions from the 

9 Clean Air Act and the Clean Water Act.

10 There's little to no ability to test for 

11 the contaminants used in the fracking industry due 

12 to trade secret protection from many of the 

13 chemicals used in this process.

14 So these issues combined to make it 

15 difficult for local communities and the 

16 Environmental Protection Agency to protect the 

17 water quality and integrity of organic farming 

18 operations.

19 We can't rely on the EPA because of a 

20 lack of regulatory authority, and in the past these 

21 threats have been confined to areas of shell gas 

22 extraction. That's not necessarily the case 
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1 anymore.

2 The injection wells that often contain 

3 over 60 different chemicals do not have to be in 

4 the locations that you see on the screen that are 

5 in this food/energy/water interface.

6 So many -- additionally, many proposed 

7 pipeline infrastructure projects will transect 

8 productive pastures and crop land. Despite these 

9 challenges, there are things we can do to be 

10 proactive.

11 The energy and agricultural interface 

12 is unique for organic agriculture and there are 

13 important discussions to have, coalitions to 

14 build, and actions to take.

15 I urge you to place this issue on the 

16 work agenda for the NOSB and know that we commit 

17 to providing any resources and assistance that we 

18 can. Thank you.

19 CHAIR FAVRE: Any questions?

20 Thank you very much. Next up is Julia 

21 Barton, followed by Patty Lovera on deck.

22 MS. BARTON: Good afternoon. My name 
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1 is Julia Barton. I'm also with the Ohio Ecological 

2 Food and Farm Association. It's nice to see you 

3 all. Thank you for your work.

4 There are two key items I'd like to 

5 address with you, today. The first has to do with 

6 inspector evaluations. Thank you for adding this 

7 to the CAC's work plan. We are very excited about 

8 that discovery today.

9 As you know, the NLP has communicated 

10 to certifiers that every organic inspector must 

11 undergo a field evaluation every year. OEFFA 

12 disagrees with this requirement.

13 We work with about 35 contract 

14 inspectors, in addition to staff inspectors, to 

15 cover about an 18-state region. Earlier, Jean 

16 asked about the cost associated with conducting 

17 annual field evaluations for inspectors.

18 We estimate an annual cost of $25,000 

19 to conduct a field evaluation for every inspector 

20 we work with every year. This is a high cost, which 

21 has been passed on to organic producers, as part 

22 of their certification fees.
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1 Here are a few examples, in which this 

2 requirement presents a challenge for us. When 

3 working with a new inspector, we determine if the 

4 contract situation is a good fit for OEFFA.

5 It's inefficient to conduct a field 

6 evaluation after just a few inspections, if we 

7 don't intend to renew that inspector's contract the 

8 following year.

9 Secondly, some inspectors, many of them 

10 farmers, or agricultural professionals, who 

11 conduct a few inspections a year for one ACA, do 

12 really excellent quality work, because of their 

13 experience.

14 This requirement offers a disincentive 

15 for working for these particular inspectors, 

16 because we would have to evaluate them every year, 

17 so low volume higher cost.

18 Finally, some inspectors do over 100 

19 inspections for one ACA and they might pick up one 

20 for OEFFA in a pinch, you know, maybe they're in 

21 a particular area, or we need a spot inspection, 

22 there are a number of reasons we might need to do 
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1 that. Again, this requirement provides a 

2 disincentive for this sort of collaboration.

3 So we are so thankful that you've taken 

4 up this issue and we, we recommend, as you move 

5 forward, a risk-based model, so we can imagine a 

6 system within which every inspector is evaluated 

7 in the field, over a period of several years.

8 The second item we'd like NOSB to please 

9 consider is the conversion of native ecosystems to 

10 organic crop production, a topic that was 

11 previously raised by our colleagues at the Wild 

12 Farm Alliance.

13 While we support the continued growth 

14 of the organic industry and the expansion of 

15 organic acreage, we do not support growth at any 

16 cost.

17 Organic growth should not be at the cost 

18 of native ecosystems. We have faith that the NOSB 

19 is equipped to find a viable solution to this 

20 challenge in partnership with the organic 

21 community. Please consider adding this issue to 

22 the work agenda. Thank you.
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1 CHAIR FAVRE: Thank you. Any 

2 questions? Scott.

3 MEMBER RICE: Thanks, Julia. I 

4 wonder, if you could speak to any cost savings, by 

5 working with a program, such as the one that IOIA 

6 put together for some of the other work that 

7 certifiers are doing to collaborate on sharing 

8 reports and, maybe, some of the logistics involved 

9 in that?

10 MS. BARTON: I don't have the numbers 

11 on the cost savings for participating in the IOIA 

12 Program, but I can tell you that we did participate 

13 in that program last year.

14 We thought it was a really great 

15 collaborative effort lead by IOIA and I think nine 

16 of our, about 30 inspectors were evaluated through 

17 that program, for the 2015 production season. So 

18 we were happy to participate with that and 

19 collaborate with other, you know, ACA folks in 

20 considering the options for this issue. 

21 We agree with the common set Pat shared 

22 earlier, Pat Kane, of the ACA, shared earlier, in 
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1 stating that, that we're not sure what the problem 

2 was that this was meant to address.

3 We were, initially, really excited 

4 about the concept of inspector evaluations and, 

5 kind of, jumped in and tried to figure out a way 

6 to make it happen, but what we're finding is that 

7 the data that we're receiving, as a result of the 

8 evaluations we're conducting every year, is not so 

9 different from the feedback that we received 

10 before.

11 We also have multiple ways of gathering 

12 that feedback. So I think a number of ACAs do 

13 this, not just OEFFA, but we, we every producer, 

14 after their inspection, has the opportunity to then 

15 share feedback about how that inspection went for 

16 them and what they thought of the job.

17 Also, our staff reviewers conduct those 

18 evaluations on the reports that they receive back, 

19 so we have a number of ways of, kind of, gathering 

20 data about that, in addition to the field 

21 evaluations, which we think are very important.

22 CHAIR FAVRE: Harold.
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1 MEMBER AUSTIN: Have you looked at what 

2 solutions and alternatives could be moved forward 

3 that could take, enable you to continue to look at 

4 using the producers, the growers out in the field, 

5 as those certifiers, even though they're not, you 

6 know, as an inspector, even though they're not able 

7 to take and do the heavy workload that a full-time 

8 inspector could do, have you guys looked at what 

9 other options might be out there?

10 Because it seems like that's a pretty 

11 valuable resource to just simply turn our back and 

12 walk away from, so I mean, I'm wondering if there 

13 could be some suggestions put forth that could help 

14 us, as we work on some of these issues, as well?

15 MS. BARTON: Sure. Thank you for 

16 bringing that up. I do think that the producer 

17 inspectors are folks with that strong production 

18 background are probably our very best inspectors. 

19 We, actually, were just talking about that, over 

20 lunch.

21 And that is a challenge, because that 

22 low volume, but they need to have those evaluations 
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1 each year, under the current requirement.

2 I think the idea that Scott raised about 

3 participating with IOIA's, sort of, collaborative 

4 efforts is a good one and IOIA tends to think really 

5 collaboratively, so we love partnering with them.

6 I think there are, probably, other 

7 options out there. I think, what would be a better 

8 fit for us would be a little bit of a more flexible 

9 requirement that we could then, kind of, use that 

10 risk-based model to assess what we think needs to 

11 be done.

12 We are given that leeway in a lot of 

13 other aspects of our work and I think we do a good 

14 job to, to meet a high standard in that, so I think 

15 we'd appreciate having it in this, in this 

16 particular shoe, as well.

17 CHAIR FAVRE: Jean and then, Harriet.

18 MEMBER RICHARDSON: Do you think it 

19 would be reasonable to have each certifier agency 

20 come up with a, sort of, a plan, as to how they would 

21 over, say that, well, the NOSB had suggested, 

22 originally, in 2010, was a three-year period, 
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1 could, do you think it's reasonable for us to ask, 

2 base, get the data from them, say, you know, we have 

3 x-number of inspectors, we would propose to do an 

4 infield evaluation of so many each year, would that 

5 be a reasonable thing to get?

6 Because one of the things I notice is 

7 that we don't actually don't know how many 

8 inspectors there are, because they're not all 

9 members of IOIA.

10 MS. BARTON: Sure.

11 (Off microphone comment.)

12 MS. BARTON: Yes, thank you for that. 

13 I think, I don't want to speak for other ACAs, but 

14 I can tell you that we already did that plan when 

15 you offered the recommendations, so we did that on 

16 paper a long time ago, and then, the recommendation 

17 from NOP, or the requirement from NOP was a little 

18 bit different, so then we had to go back and revisit 

19 that.

20 I suspect, knowing other ACAs that 

21 they, also have done those plans for themselves and 

22 thought through this. We tend to have to do a lot 
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1 of that in this type of work, so I think we are 

2 pretty good at that sort of thinking. I can tell 

3 you for sure that OEFFA would be happy to provide 

4 you with that information.

5 CHAIR FAVRE: Harriet.

6 MEMBER BEHAR: Two things. Hi, Julia. 

7 I just wanted to encourage the ACAs to really work 

8 together, because so many inspectors work for 

9 multiple agencies and work with IOIA to have that 

10 evaluation really be consistent between agencies, 

11 and so then, also, you will feel confident in 

12 sharing the evaluations with others and they would 

13 feel confident that those questions and the 

14 evaluation methods were some that they, that they 

15 trust and that they feel meet their requirements.

16 And the second thing about the high 

17 value ecosystem transition to organic, thank you 

18 for bringing that up. And I'm just wondering, a 

19 lot of times we think about this, perhaps, this is 

20 overseas and this is not necessarily here in the 

21 United States, but in Ohio are there areas that you 

22 feel that are being endangered to being 
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1 transitioned to organic that really should have 

2 been remained, you know, in their pristine 

3 high-value ecosystem?

4 MS. BARTON: That's a really good 

5 question. I think, this came up a little bit 

6 yesterday at the NOC pre-NOSB meeting and the 

7 conversation about new farmers and farmers 

8 transitioning to organic and their choices about 

9 whether to certify or not, and one of the barriers 

10 that we know is there and that type of situation 

11 is being able to have access to land that has not 

12 previously had a prohibited substance applied to 

13 it, recently, so we can hit the ground running, as 

14 a certified operator.

15 We know that that makes a big difference 

16 in direct marketing, so you don't have a changing 

17 personality on transitional, oh no I'm organic, oh 

18 but I'm transitioning additional land, but this 

19 stuff is organic, but this stuff isn't, and that 

20 becomes, you know, tricky conversation to have in 

21 any, any selling situation, but, maybe, even a 

22 little bit easier in a direct market situation, but 
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1 still difficult.

2 So I think the risk there is very high 

3 for native ecosystems that are very valuable to be 

4 converted. I don't have data on, or, or even less 

5 specific example that I can give you, right off the 

6 top of my head, but I know it's happening and it's 

7 happening, because we incentivize it. So we have 

8 power to change that. Well, you all do.

9 CHAIR FAVRE: Thank you, Julia.

10 MS. BARTON: Thank you for your work.

11 CHAIR FAVRE: Next up is Patty Lovera, 

12 and she'll be our last commenter, before we take 

13 a break.

14 MS. LOVERA: All right. Hi, my name's 

15 Patty Lovera. I'm the Assistant Director of Food 

16 and Water Watch and we're a national non-profit 

17 advocacy organization and we're also a member of 

18 the National Organic Coalition.

19 So I'm going to try to hit a bunch of 

20 topics and then you all can take a break. So first, 

21 a lot of folks are putting in comments and I know 

22 there will be more discussion tomorrow on excluded 
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1 methods, but I also just wanted to echo that we 

2 think that the CODEX definition not the Cartagena 

3 Protocol is the way to go.

4 And just a couple of other points I 

5 wanted to emphasize. On that excluded methods 

6 conversation is the need to really be very clear 

7 about synthetic biology, it is something that's 

8 emerging and it needs to have some hands wrapped 

9 around it and really be drawn out in that 

10 definition.

11 And also, just emphasis, some emphasis 

12 on organisms, in addition to plants, we're now 

13 talking about genetically engineered food, 

14 animals, insects, and in lots of places in the 

15 document I think we could add some, and animals, 

16 or, and other organisms, in addition to other 

17 places where it said plans, and just to put this 

18 into the context we're dealing with more broadly. 

19 I mean, the whole federal government is 

20 trying to redo the coordinative framework for how 

21 we deal with biotechnology. We are living through 

22 some of examples of that framework not working when 
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1 it comes to things like genetically engineered 

2 insects.

3 You know, one company seen technology 

4 two different agencies, depending on the insect. 

5 I mean, there's a lot of need to figure this out, 

6 and so that, to me, indicates a need for the NOSB 

7 to have a more regular process to update these 

8 definitions, because the technologies are changing 

9 and they're changing pretty quickly.

10 Really quickly, on several materials. 

11 We support the position on carrageenan not to be 

12 re-listed for the reasons that Charlotte laid out 

13 so clearly, in terms of making a precautionary 

14 choice, we think that is to not allow carrageenan 

15 to be re-listed.

16 And then, there are several items on 

17 your agenda for this meeting that really boil down 

18 to transparency for us and for our members, so for 

19 nutrient vitamins and minerals, the need to list 

20 them individually and review them individually we 

21 think is a transparency issue, similarly for inerts 

22 that each one gets looked at and they get a full 
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1 review, and then, also, on ancillary substances, 

2 they need to individually review them to get to the 

3 criteria.

4 And then, the final material I'll add 

5 is that I agree with the proposal not to allow the 

6 use of ash from manure burning, because it really 

7 props up the factory farming industry.

8 And then, finally, on fracking, I was 

9 glad to follow some folks from Ohio, who are living 

10 through what the oil and gas industry has the 

11 potential to do to lots of rural areas, but also 

12 other areas, and organic has to be a community 

13 that's willing to talk about that and talk about 

14 what's at risk, the soil and water that we use to 

15 grow clean food is at risk.

16 But, I also think, specifically, for 

17 the NOSB, this is a conversation about inputs and 

18 what it means to have inputs that are acceptable 

19 for organic, and I think we're not going to be able 

20 to avoid, for very much longer, the conversation 

21 about water, as an input, and what it means when 

22 you're looking at the water you're using to 
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1 irrigate crops. We've had examples already from 

2 traditional oil drilling and I'm afraid we're going 

3 to have more examples soon, because of fracking. 

4 So thank you.

5 CHAIR FAVRE: Thank you, Patty. Any 

6 questions for her?

7 (No response.)

8 CHAIR FAVRE: Thank you very much.

9 MS. LOVERA: Okay, thank you.

10 CHAIR FAVRE: Okay, folks, we're right 

11 on schedule, right now, so we're going to take a 

12 15-minute break and have everybody reconvene here 

13 back at 4:15 p.m. Thank you.

14 (Whereupon, the above-entitled matter 

15 went off the record at 3:59 p.m. and resumed at 4:16 

16 p.m.)

17 CHAIR FAVRE: Okay. I'd like the 

18 Board Members to take their seats so we can started 

19 back please. If you're in the room, Board Members 

20 please take your seats. Those of you out in the 

21 hallway, if you'll let folks know we're going to 

22 get started back again.
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1 First up in our commenters after the 

2 break is Patrick Kerrigan. And we have Terry 

3 Shistar on deck.

4 MR. KERRIGAN: Good afternoon. 

5 Organic Consumers Association once again calls on 

6 the NOSB to delist carrageenan as an unnecessary 

7 and unhealthy ingredient for consumers of 

8 processed foods.

9 Since its initial approval in 1995, 

10 carrageenan has subsequently been reapproved by 

11 the NOSB with every five year sunset review while 

12 debating for decades about whether or not food 

13 grade carrageenan degrades when ingested.

14 It behooves the NOSB to acknowledge the 

15 ensuing result, that of all the suspect substances 

16 that have been and are being relisted, carrageenan 

17 has become the poster product for the eroding trust 

18 of organic consumers and the integrity of organic 

19 foods because of synthetic substances being 

20 continuously relisted.

21 And this is something that's well known 

22 as far as the health concerns. POLITICO Pro 
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1 Agriculture's lead article this morning, the headline 

2 was Carrageenan Organic Battle Continues.

3 At this meeting, you have the golden 

4 opportunity to rebuild consumer trust in both the gold 

5 standard, that is the USDA Organic Seal, and to 

6 rebuild the damaged consumer confidence in NOSB's 

7 relisting of suspect synthetic substances by voting 

8 to delist carrageenan.

9 As at the 2012 Albuquerque NOSB meeting, 

10 the primary considerations before the NOSB is whether 

11 the use of carrageenan by organic food processors is 

12 indeed essential. And whether the unknown 

13 inflammation, cancer, and intestinal ulceration 

14 dangers of low molecular degraded carrageenan can 

15 result when contaminated food grade high molecular 

16 carrageenan is ingested.

17 Regarding essentiality, organic brands 

18 including White Wave and Stonyfield have substituted 

19 other ingredients including guar gum and locust bean 

20 gum for carrageenan in response to organic consumer 

21 backlash. Other companies included the message 

22 shake well on their packaging.
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1 Does the NOSB really believe that 

2 consumers would rather have such a controversial 

3 ingredient as carrageenan added to an organic product 

4 so that they don't have to shake it?

5 Regarding the safety aspect, what is 

6 clear is that under the NOSB's own previous 

7 determination, that food grade carrageenan is safe if 

8 and only if processors can guarantee that it will not 

9 degrade to low molecular poligeenan.

10 Inflammation, cancer, and ulceration of 

11 the colon concerns with carrageenan go back to the 

12 1960s when it was found that food grade carrageenan 

13 contributes to the ulcerative colitis-like disease in 

14 guinea pigs.

15 When the European Commission's 

16 Scientific Committee on Food reviewed safety data on 

17 carrageenan, they concluded that food grade 

18 carrageenan is not safe unless the amount of degraded 

19 carrageenan is cut to a minimum which they suggested 

20 at levels below five percent.

21 As Cornucopia Institute noted, this 

22 decision prompted the laboratory testing of food 
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1 grade carrageenan by the industry, which revealed 

2 that no food grade carrageenan sample could 

3 confidently be shown to be free from degraded 

4 carrageenan at concentrations below five percent.

5 Could I just say my final closing comment? 

6 Finally, the PPM's a critically important process for 

7 ensuring the statutory authority vested in the NOSB 

8 by the OFPA. With so much at stake, more time is 

9 needed for public comments. Please table it for this 

10 meeting.

11 Thank you for your consideration. And 

12 thank you for your time. I know it's a huge job, so 

13 we really appreciate your volunteering. Thanks.

14 CHAIR FAVRE: Thank you. Questions for 

15 Patrick? Okay. Thank you very much. Next up is 

16 Terry Shistar followed by Henry Dao on deck.

17 DR. SHISTAR: Okay. My name is Terry 

18 Shistar and I'm on the Board of Directors of Beyond 

19 Pesticides. We have a long history of involvement 

20 with organic production. And these are a few of our 

21 current and former Board Members.

22 We have submitted comments on all of the 
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1 issues before the Board at this meeting. My comments 

2 today summarize a few of the issues, starting with 

3 so-called inert ingredients.

4 The NOSB must conduct a real sunset review 

5 of List 3 inerts. The Board previously identified 

6 those used in organic production and recommended that 

7 their use expire on December 31, 2015. Respecting 

8 that vote, as the NOP did not, the NOSB should vote 

9 to delist them.

10 NPEs can and should be replaced as soon 

11 as possible with safer alternatives. The NOSB must 

12 ensure that the fall of 2015 recommendation on the 

13 inerts annotation is implemented in a way that ensures 

14 NOSB control at the initial review and future sunset 

15 review of the chemicals.

16 The NOSB should delay recommending the 

17 addition of more sanitizers until it performs a 

18 thorough review of all sanitizers, disinfectants, and 

19 their uses, one that determines needs for sanitizers 

20 in organic production and handling and compares the 

21 safety and effectiveness of the available materials 

22 with an eye to eliminating chlorine-based and other 
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1 hazardous materials.

2 The review of hypochlorous acid must take 

3 into account the sodium hydroxide and hydrogen that 

4 are co-generated with it. SDBS is on EPA's safer 

5 chemical ingredients list but again, should be part 

6 of a comprehensive review.

7 The process for reviewing ancillary 

8 substances must require them to be evaluated relative 

9 to OFPA criteria and approved for specific uses.

10 Added vitamins and minerals, synthetic or 

11 non-synthetic, should not be permitted in products 

12 labeled organic unless required by law. Consumers 

13 expect that organic food contains a complete 

14 compliment of nutrients based on organic agricultural 

15 protection practices, not supplementation.

16 Carrageenan does not meet OFPA criteria. 

17 And due to consumer concerns, it has been removed from 

18 many organic products. And every organic product 

19 containing carrageenan is available without it.

20 Since the intention of the NOSB in 

21 approving fenbendazole was to allow for the removal 

22 of ivermectin and possibly moxidectin, parasiticides 
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1 should be referred back to the subcommittee to return 

2 with options that address the full range of actions 

3 supported by the available evidence. Jay is going to 

4 address the PPM.

5 We prefer a sunset date reorganization 

6 that groups materials in functional classes. But our 

7 main message is just do it. Thank you.

8 CHAIR FAVRE: Great slide transition 

9 there at the end. Questions for Terry? Ashley?

10 MEMBER SWAFFAR: Terry, I just want to 

11 say one thing. I loved your comment about the sunset 

12 reorganization where you suggested we just lock 

13 everybody in a room until we all decide. And those 

14 of us who lived through sunset 17 agree with you.

15 DR. SHISTAR: Yes, I lived through it 

16 too.

17 CHAIR FAVRE: Any others? Jean?

18 DR. SHISTAR: Hi Jean.

19 MEMBER RICHARDSON: Back to your comment 

20 on the parasiticide thing, I'm hoping that I'm going 

21 to be able to address that when I give the presentation 

22 on how we're going to approach it. One of the ways 
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1 is that we are looking to petition for the removal of 

2 ivermectin. But as a separate item, not all part and 

3 parcel, as soon as we can see the way clear. And I'll 

4 be able to explain that better on Tuesday when we do 

5 that presentation.

6 DR. SHISTAR: Okay. Thank you.

7 MEMBER RICHARDSON: Thanks.

8 CHAIR FAVRE: Harold?

9 MEMBER AUSTIN: Terry, how would you 

10 advise us to move forward with sodium 

11 dodecylbenzenesulfonate at this juncture?

12 DR. SHISTAR: You know, that's an 

13 interesting one that I had mixed feelings about. 

14 Because when I looked into it and found that it was 

15 on the safer chemical ingredients list which is where 

16 I've recommended you look for alternative sanitizers, 

17 I found -- well there's one problem.

18 And that was that it appears that not all 

19 the data is complete. There's a study missing on 

20 acute eye irritation or something like that. But the 

21 main thing is that I think that the NOSB needs to 

22 address all the sanitizers together to really -- and 
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1 somebody else brought this up earlier, to really look 

2 at what the needs are.

3 We keep getting references to, well this 

4 required by law. The review of the nutrient vitamins 

5 and minerals looked at the what the laws actually said 

6 for different things.

7 And I think that something similar needs 

8 to be done for the sanitizers and disinfectants. We 

9 need to know what the legal requirements are. And 

10 also what the efficacy requirements are.

11 CHAIR FAVRE: Thank you. Okay. Next up 

12 is Henry Dao with Keith Kandt on deck.

13 MR. DAO: Good afternoon ladies, 

14 gentlemen, and members of the NOSB Board Members. 

15 Thanks for the opportunity to provide comments. I'm 

16 Henry Dao from HSP USA. We've been serving our 

17 customers for over 20 years in food safety and 

18 healthcare. My day started at 3:00 a.m. this morning 

19 from Philly. So I hope I make sense here.

20 So we support adding hypochlorous acid 

21 without any limitation to the National List under 

22 chlorine materials for all three categories. From a 
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1 scientific standpoint, hypochlorous acid is a 

2 well-known antimicrobial substance. And it's one of 

3 the many substances in electrolyzed water. 

4 Electrolyzed water is not a substance but a production 

5 method.

6 So hypochlorous acid is also formed when 

7 hypochloride is added to water. For example, you do 

8 that for a swimming pool. So ever since hypochlorous 

9 is used, hypochlorous acid has been around. So it's 

10 not really a new substance. And hypochloride is 

11 already approved on the National List.

12 And from a policy standpoint, there's no 

13 difference in hypochlorous acid as a substance when 

14 it's generated by different methods. And none of the 

15 other substances current on the List is tied to any 

16 production methods. For example, chlorine dioxide, 

17 even including sodium hypochloride, peracetic acid, 

18 so none of them have been tied to any methods. So we 

19 felt that neither should hypochlorous acid be.

20 And from a substantial evidence 

21 standpoint, hypochlorous acid is proven to be a safe 

22 substance. There are many scientific literatures 
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1 that you can cite that proves it's safe, effective.

2 From our standpoint, our hypochlorous 

3 acid product is approved as a food contact substance. 

4 So it has a food contact notification by the FDA, 

5 Number 1176, and is also reviewed by USDA.

6 So in conclusion, we request NOSB to make 

7 decisions based on the sound science around 

8 hypochlorous acid as a substance. And consistency in 

9 rules, meaning that other products don't have any 

10 methods tied to it. And based on the substantial 

11 evidence already available for safety and 

12 effectiveness. Thank you.

13 CHAIR FAVRE: Tom?

14 VICE CHAIR CHAPMAN: You made a statement 

15 that other substances on the National List don't have 

16 production methods tied to them. Maybe not on the 

17 sanitizers category, but there are several substances 

18 that we do limit the way it's manufactured. Calcium 

19 sulfite has an annotation that says mined. So it's 

20 only from mined sources how it's made.

21 And there are numerous other examples. I 

22 could give you more if I need to. But I can think of 
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1 four or five off the top of my head. So given that, 

2 our committees has only reviewed the electrolyzed 

3 water form of manufacturing it.

4 And that our criteria are more than just 

5 safety. It's environmental health, compatibility 

6 with organic handling systems and production systems. 

7 Would it be prudent for us to just add this to the List 

8 at this time without further review?

9 MR. DAO: Well we believe that you should 

10 focus on the substance itself. I think electrolyzed 

11 water is not a substance. It's actually a mixture of 

12 things including hydrogen peroxide, for example. 

13 There's many species of oxidants within that 

14 electrolyzed water.

15 So we want recommend that you focus on the 

16 substance itself, which is proven to be safe and 

17 effective. And not just calling it electrolyzed 

18 water because it could be generated many different 

19 ways. Like you said, it is -- or we focus on 

20 antimicrobials space. So for example, chlorine 

21 dioxide could be generated including electrolytic 

22 technology.
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1 VICE CHAIR CHAPMAN: Yes. I guess my 

2 point was saying that when we add substances, we 

3 evaluate numerous ways of producing it depending on 

4 the way it was petitioned. This one was petitioned 

5 to us as electrolyzed water, hydrochlorous acid 

6 generated via electrolyzed water.

7 And so we did not expand that review to 

8 all these other manufacturing methods. Often times 

9 when we do expand our view to other manufacturing 

10 methods, we choose to narrow the scope of what's 

11 allowed.

12 I'm not saying that we would not, if we 

13 had a wider view, not accept this method of producing 

14 hypochlorous acid. But without reviewing it, I don't 

15 know if it's prudent for us to add it at this time.

16 MR. DAO: Right. I mean our view is, we 

17 review on the substance, right? So I think, I don't 

18 know how the other substance are reviewed. But this 

19 jumps out that it is somewhat tied to a method. Maybe 

20 people are not aware of other methods. Because if you 

21 look at chlorine dioxide, there are many methods of 

22 generating that including electrolytic technology.
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1 I don't know if that substance, when it 

2 was petitioned, was reviewed, the production methods, 

3 all the various production methods were reviewed as 

4 well. So from a consistency standpoint, we felt that 

5 we fall in the same category.

6 VICE CHAIR CHAPMAN: It depends on how 

7 it's petitioned in that case. But I'll stop with the 

8 back and forth.

9 CHAIR FAVRE: Thank you. Any other 

10 questions for him? Francis?

11 MEMBER THICKE: I'm not real clear. 

12 You're suggesting that you can -- you make it in 

13 another process? And is it stable? And is it at the 

14 same concentration of pH that --

15 MR. DAO: Actually, yes. To answer your 

16 question, we manufacture hypochlorous acid in a much 

17 purer form than what's being made available by 

18 electrolyzed water. Because electrolyzed water, it 

19 is a cocktail of oxidants depending on the pH and 

20 everything. So it includes many different species of 

21 oxidants.

22 Like the speaker prior to me suggested, 
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1 hydrogen peroxide is in there. And sodium hydroxide 

2 is also in there.

3 MEMBER THICKE: Okay. And is it, the 

4 manufacturing method you're talking about, is it a 

5 neutral? What pH are you suggesting it would be at?

6 MR. DAO: Near neutral, yes.

7 MEMBER THICKE: It would be at neutral?

8 MR. DAO: Yes, 6.8, 6.5. It's nothing 

9 different from a characteristic standpoint. It's 

10 hypochlorous acid. It's a weak acid --

11 MEMBER THICKE: Right.

12 MR. DAO: -- existing in a solution form. 

13 And it's very common in the industry that you use some 

14 kind of food grade acid to adjust pH when you add 

15 hypochloride to water to increase the amount of 

16 hypochlorous acid to make it more effective.

17 MEMBER THICKE: Well the technical 

18 reviews seemed to indicate that it will decay back to 

19 sodium chloride in water, dissipate spontaneously 

20 over a short time. But you're saying that you keep 

21 it in a stable form.

22 MR. DAO: Yes.
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1 MEMBER THICKE: And do you use other 

2 chemicals to keep it in a stable form?

3 MR. DAO: Well like I said, there's many 

4 methods for it. And then there's one common method 

5 in the industry is adding food grade acid to, really 

6 for a pH adjustment. And it's like citric acid, for 

7 example, acetic acid, like vinegar. And it's very 

8 common practice actually to do that. And it is widely 

9 used in the food industry, as you know.

10 And also, it could use carbon dioxide. 

11 As a common practice, you inject carbon dioxide as to 

12 lower the Ph. So those are the methods that I just 

13 mentioned in addition to electrolyzed water.

14 CHAIR FAVRE: Harold?

15 MEMBER AUSTIN: Okay. So in our review 

16 of the hypochlorous acid via the electrolyzed water 

17 formulation on site, the primary materials coming 

18 from both the cathode and the anode of the equipment 

19 itself is ultimately used.

20 With your formulation, is there any 

21 byproducts that are part of the formulation process

22 that's not used in the formulation of the hypochlorous 
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1 acid?

2 MR. DAO: No, there's no byproducts like 

3 sodium hydroxide. But as an inner ingredient, it 

4 does have salt. So it's table salt inside, in the 

5 solution itself.

6 And to answer your question that some 

7 sodium hypochlorite could be generated by 

8 electrolytic technology as well. And by other 

9 methods, in terms of sodium hypochlorite. Just you 

10 know, since sodium hypochlorite is already on the 

11 list, and just drawing by analogy that, looking at the 

12 other materials, not all of them are tied to any 

13 methods.

14 CHAIR FAVRE: Thank you very much.

15 MR. DAO: Thank you.

16 CHAIR FAVRE: Next up is Keith Kandt 

17 followed by Laura MacCleery on deck.

18 MR. KANDT: Hi my name is Keith Kandt. 

19 I'm with NatureSweet Tomatoes. And I want to add my 

20 thanks to the others that you've heard for the time 

21 and effort that you're putting in to address a lot of 

22 I know pretty thorny and complex issues. So I 
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1 appreciate that.

2 What I'd like to do is take a few minutes 

3 to outline what I think are some of the important 

4 reasons that we need to have the continued acceptance 

5 of containerized growing as a viable option and why 

6 that's an attractive idea.

7 Containerized growing, first of all, has 

8 a minimal impact on the environment. Care for the 

9 future of the planet is a core pillar of the organic 

10 philosophy. And I know that the farmers of field 

11 grown organic products are careful to minimize 

12 erosion, water usage, and fertilizer runoff among 

13 other things.

14 Yet we still know that erosion happens, 

15 water is wasted, fertilizer is lost even with the best 

16 of efforts. I ask you to consider containerized or 

17 greenhouse growing and the environmental impact of 

18 what we do. There is no runoff, zero soil erosion.

19 In fact, at NatureSweet, and similar to 

20 what a lot of other folks have said earlier, our water 

21 is recycled. Our fertilizer is recycled and absorbed 

22 back into the plants. Our water usage is typically 
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1 about 80 to 90 percent less per pound than the water 

2 used for field growing.

3 And our yields are about eight times that 

4 of field grown tomatoes based on some data that the 

5 USDA has provided. Plus we can execute that 

6 containerized growing on a footprint of land that may 

7 be otherwise arid or practically unusable.

8 So what all this allows us to do as a 

9 people is to provide quality, safe produce to the nine 

10 billion people that we're going to have on this planet 

11 very soon. And that leaves us a lot of other land that 

12 we can maintain either untouched or for other uses or 

13 just to enjoy as beautiful, as it is.

14 Now of course, there are a significant 

15 number of significant sized companies that utilize 

16 greenhouse or containerized growing, and I'm happy to 

17 recognize that. But what I'd also ask you to 

18 recognize is that organic greenhouse growing or 

19 containerized growing is overwhelmingly done by very 

20 small farmers.

21 For every NatureSweet tomato out there, 

22 there is at least 100 or probably hundreds of small 
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1 family farms that are trying to grow organic produce 

2 in greenhouses or in containers.

3 Also, I see no evidence of a consumer 

4 outcry on this issue. We've done a lot of research. 

5 And consumers' concerns are that it's safe, that it's 

6 available, and that it's flavorful. But there is 

7 really no angst out there about whether the organic 

8 produce comes from a greenhouse or from a field.

9 So just to leave it right there, I just 

10 hope you will agree that leaving greenhouse growing 

11 and containerized growing as a viable option as we 

12 move into the future is really the right thing to do. 

13 Thanks.

14 CHAIR FAVRE: Emily?

15 MEMBER OAKLEY: Got my new microphone 

16 that I can actually use. I was wondering if you could 

17 answer whether most of these operations are on cement 

18 pads? Because you spoke of soil erosion. And I'm 

19 wondering about the concern of covering the soil with 

20 cement.

21 MR. KANDT: I don't have any statistics 

22 that I can give you as to what percentage of them would 
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1 be cement pads versus not. I can try to find some out 

2 and get some to you if that'd be helpful. Okay.

3 CHAIR FAVRE: Harold?

4 MEMBER AUSTIN: Compared to soil-based 

5 crop production, what would be the yield, the output 

6 on this system versus the equivalent on a soil-based? 

7 I mean are you able to grow multiple crops throughout 

8 the growing season because of this compared to a 

9 soil-based --

10 MR. KANDT: Yes, and I maybe wasn't 

11 clear. But our productivity over a year, for 

12 instance, is about eight times what field grown 

13 organics come back with. And that number, the base 

14 number for field grown organics is a number that was 

15 published by the USDA. So we did our calculation off 

16 of that.

17 CHAIR FAVRE: Thank you very much.

18 MR. KANDT: Okay. Thanks.

19 CHAIR FAVRE: Next up is Laura MacCleery 

20 followed by Deborah Klein on deck. Is Laura 

21 MacCleery here? Last call for Laura. Okay. 

22 Deborah, if you want to go ahead and join us.
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1 MS. KLEIN: Sure. Thank you very much. 

2 Good afternoon. I'm Deb Klein with Ecolab. And I 

3 wanted to say we can appreciate the many commenters 

4 here today wishing to preserve the integrity of 

5 organic, their healthy choices, and our planet.

6 I'm here to represent and to talk about 

7 food safety. The addition of SDBS to the organic 

8 processing and handling list will help small grocers, 

9 restaurants, food service, and kitchens have a safe 

10 washwater treatment to ensure dangerous foodborne 

11 pathogens are able to be rinsed off our organic 

12 fruits, vegetables, and produce and ensure the 

13 health, safety, and integrity of our organic food 

14 supply. We must be vigilant that organic product not 

15 be the source of foodborne outbreaks.

16 In these few minutes, I hope to provide 

17 the subcommittee and others here today with a frame 

18 of reference and address the committee's questions 

19 for this processing aid.

20 SDBS is a critical synthetic needed in our 

21 restricted toolbox as an alternative to the few 

22 chlorine-based products such as sodium hypochlorite 
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1 in the market today. Other approved products on the 

2 National List such as acidified sodium chlorite, 

3 peroxyacetic acid are suitable for the large 

4 processors. But they're not convenient or practical 

5 for small processors.

6 Retailers need alternatives to address 

7 spoilage organisms and pathogens present during their 

8 rinsing and prepping of produce for sandwiches and our 

9 salads. SDBS is proven effective to protect public 

10 health.

11 It's an active and a surfactant to boost 

12 the efficacy of lactic acid. It performs better in 

13 the presence of high organic loading than other 

14 synthetics such as sodium hypochlorite or chlorine.

15 Chlorine presents a couple of challenges 

16 to food safety. It's difficult to control and 

17 maintain the proper concentration. It's easily 

18 overcome by organic matter. And some systems require 

19 complex equipment to generate the hypochlorous acid 

20 which makes it difficult and potentially unsafe for 

21 workers.

22 SDBS overcomes these challenges through 
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1 its enhanced efficacy in the presence of high organic 

2 loading post-harvest. Its dispensing is automated, 

3 and it improves product quality, reducing the 

4 spoilage organisms via less trimming, waste, and 

5 discarded product going to the landfill. This 

6 improves organic yields and profits.

7 SDBS is manufactured to be suitable for 

8 food. Impurities of the Board's concern are 

9 addressed in modernized manufacturing practice to 

10 remove and eliminate these impurities of concern. 

11 SDBS presents no toxicity, residual, or persistent 

12 substances to the environment or human consumption. 

13 And it's been reviewed exhaustively by FDA and EPA 

14 with toxicological and environmental impact 

15 assessment.

16 We appreciate and support the need to 

17 protect the integrity and purity of organic product, 

18 but also balancing the need for food safety and 

19 ensuring the health and wellbeing of organic 

20 consumers, and urge the subcommittee to vote in favor 

21 of adding this valuable and essential tool for organic 

22 retailers and kitchens, at least until an alternative 
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1 can found. That's my last comment. Any questions?

2 CHAIR FAVRE: Tom?

3 VICE CHAIR CHAPMAN: Can you help me 

4 understand why PAA is not available in smaller 

5 quantities? You spoke to restaurants and other 

6 retail establishments.

7 MS. KLEIN: Most of the PAA out on the 

8 market today and manufactured by the larger 

9 manufacturers, and there are 30 of them distributing 

10 them, they come in 50 gallon drums or 300 gallon totes. 

11 And they are in an automated system to dispense it.

12 But they're not available like in a two 

13 and a half gallon container or five gallon container 

14 or one gallon containers that are much more convenient 

15 for a retailer in the back of the kitchen.

16 VICE CHAIR CHAPMAN: Is there something 

17 about PAA that is like, that requires it in those 

18 bigger quantities? Or is that just the market 

19 situation?

20 MS. KLEIN: It's just the market 

21 situation. I mean there are PAAs like Victory and 

22 some of those. But they're like, in the European 
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1 market, not in our North America market.

2 VICE CHAIR CHAPMAN: Thank you.

3 CHAIR FAVRE: Harold?

4 MEMBER AUSTIN: In one of the written 

5 responses back to us, it addressed one of our concerns 

6 about human health issues around this material and 

7 exposure. And one of the comments was that it was, 

8 at the point of use, it was such a minute amount. But 

9 our review is really not about the finished product, 

10 but really about sodium dodecylbenzenesulfonate.

11 MS. KLEIN: Right.

12 MEMBER AUSTIN: So my question to you 

13 then would be, human health concerns around that as 

14 far as any exposure to that material, not the finished 

15 material. What would be our concerns with that?

16 MS. KLEIN: You wouldn't have exposure to 

17 the direct concentrate because in most situations, 

18 it's going to be blended with something else like a 

19 lactic acid because it's more of a surfactant. It's 

20 not used in the wash water in and of itself 

21 necessarily.

22 But they wouldn't be handling the 
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1 concentrate. It would be dispensed through an 

2 automatic dispenser. It's like not like you're going 

3 to measure out and pour it into the wash water in a 

4 sink.

5 So the -- that's one of the things is the 

6 workers wouldn't be exposed to that. So they 

7 wouldn't have that eye irritation or skin irritation. 

8 That's more with the concentrate in an MSDS.

9 MEMBER AUSTIN: What about at the point 

10 of manufacture as far as the combination of the two 

11 materials? Would there be any concerns there?

12 MS. KLEIN: Well they would be trained 

13 people who would be doing that. And it would be in 

14 a larger environment, like in Ecolab or like in 

15 Enviro-Tech or something like that, FMC. I mean I 

16 think we're one of the only manufacturers of it.

17 But it would be in a manufacturing 

18 facility that's controlled and has processes and 

19 proper PPE and those kinds of things. Nobody would 

20 be handling it that's not fully trained.

21 MEMBER AUSTIN: Follow-up, the material 

22 itself, SDBS, is it truly, does it have antimicrobial 
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1 activity in this finished product? Or is it simply 

2 a non-ionic surfactant that's helping the lactic acid 

3 that it's combined with?

4 MS. KLEIN: It's both. It does boost the 

5 lactic acid. And it is an active, it is an active 

6 antimicrobial as well as provides a surfactant. I 

7 don't know if I'd call that a secondary benefit, but 

8 it's a co-benefit.

9 MEMBER AUSTIN: Okay. Thank you.

10 CHAIR FAVRE: Thank you very much.

11 MS. KLEIN: Thank you.

12 CHAIR FAVRE: Okay We've got Martin 

13 Gramckow, I'm not sure how to pronounce that, sorry, 

14 up next. And we've got Robert Rankin on deck please.

15 MR. GRAMCKOW: Hello honorable members 

16 of the National Organic Standards Board. My name is 

17 Martin Gramckow. Together with my brother, I own 

18 Southland Sod Farms. We are located in Southern 

19 California.

20 We grow a variety of crops including turf 

21 grass, tangerines, hay, blackberries, raspberries, 

22 and blueberries. I grow my berries organically. I 
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1 grow them both in the soil and in containers.

2 In November of last year, we received a 

3 letter from our marketer that the CCOF would not be 

4 carrying organic container production into 2016. I 

5 had spent the previous four years personally learning 

6 the complexities of container production and had just 

7 invested a significant sum in an expansion to be 

8 certified this year.

9 While the CCOF has since reversed its 

10 position, that got my attention, and it initiated my 

11 involvement in this process. I've learned as a 

12 grower that each crop and each location has unique 

13 requirements.

14 Our organic blackberries are grown in a 

15 location where they thrive natively. The soil and 

16 climatic conditions are simply ideal. And little is 

17 needed with respect to soil amendments and climate 

18 amendment.

19 Our organic blueberries are a different 

20 story indeed. Blues grow naturally in well-drained, 

21 acidic soils which are not common in my area. Growing 

22 in a container allowed us to recreate the soil 
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1 conditions needed for the natural biological 

2 processes to thrive in the root zone, producing now 

3 in a location that would otherwise be unsuitable.

4 Container production simply saves water. 

5 My container production consistently uses 50 percent 

6 less water than my own in ground production. And as 

7 you've heard here today, some indoor systems are 

8 reporting staggering 90 percent water savings. And 

9 sustainability, when viewed through the water savings 

10 optic, is simply undeniable.

11 Imagine that if the majority of 

12 California farmers adopted this method, we would not 

13 have a drought. Very soon, this Board will receive 

14 technical reports from the task force on the subject 

15 of containers, hydroponics, and aquaponics.

16 You will be faced with the task of 

17 assessing whether these systems meet the requirements 

18 of the organic certification. You have received and 

19 will likely continue to receive pressure from groups 

20 fighting against these methods. And I respectfully 

21 ask Members of this Board to maintain objectivity in 

22 the process of establishing new standards for these 
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1 systems.

2 Identify your objectives first. Then 

3 develop the rules that allow growers flexibility in 

4 how to meet them. Be careful not to protect or limit 

5 systems. My view is that the job of the NOSB is to 

6 preserve the integrity of the organic program in the 

7 eyes of the consumer.

8 I thank you for your time. And if anyone 

9 has any questions --

10 CHAIR FAVRE: Carmela?

11 MEMBER BECK: Martin, you didn't get a 

12 chance -- you mentioned that you do both in ground and 

13 you do container production. Can you talk a little 

14 bit about the function or purpose of the media that 

15 you use?

16 MR. GRAMCKOW: So essentially the media 

17 in the container provides the exact same purpose that 

18 the soil does in the open field. It provides 

19 structure for the plant. It provides moisture and pH 

20 buffering. And it provides a location for the 

21 biology to thrive. Anything else?

22 CHAIR FAVRE: Any other questions? 
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1 Thank you very much. Next up is Robert Rankin. And 

2 they we'll have Jane Shey on deck.

3 MR. RANKIN: Good afternoon. My name is 

4 Robert Rankin, and I am speaking on behalf of the 

5 Infant Nutrition Council of America. INCA is an 

6 association of manufacturers and marketers of 

7 formulated nutrition products whose member companies 

8 produce over 95 percent of the infant formula, 

9 including infant formulas marketed as organic in the 

10 U.S.

11 My comments focus on the Handling 

12 Subcommittee's proposed annotation change for 

13 vitamins and minerals and the sunset review of 

14 carrageenan.

15 INCA appreciates the Handling 

16 Subcommittee's efforts to propose options and 

17 annotations to address nutrient vitamins and 

18 minerals.

19 INCA and its member companies strongly 

20 believe that infants who are not breast fed receive 

21 an alternative that is both safe and efficacious.

22 The American Academy of Pediatrics, the 
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1 U.S. Food and Drug Administration, and other experts 

2 agree infant formula is the only safe, recommended, 

3 and nutritious alternative to breast milk.

4 Organic infant formulas contain required 

5 essential nutrition while offering additional safe 

6 and beneficial ingredients that are provided in 

7 conventional products. We strongly believe that 

8 infants who consume organic infant formulas should 

9 receive the same safe and beneficial ingredients as 

10 those who consume conventional products.

11 We believe the National Organic Program 

12 has already begun addressing the listing of nutrient 

13 vitamins and minerals in organic food including 

14 infant formula through a 2012 proposed rule. This 

15 rule clearly outlines a process for determining the 

16 appropriate vitamins and minerals to be contained in 

17 organic foods and organic infant formulas.

18 If the NOSB wishes to recommend an 

19 annotation based on the discussion document, INCA 

20 supports a new annotation for infant formula that is 

21 similar to the proposed Annotation Number 4 and would 

22 also reference 21 CFR 101.9. Specific language 
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1 incorporating this addition was submitted through our 

2 written comments, and I can provide it if needed.

3 Incorporating 21 CFR 101.9 into the 

4 annotation for infant formula would ensure all 

5 current and future vitamins and minerals identified 

6 as essential or required or permitted by the U.S. FDA 

7 to be used in organic infant formulas.

8 The INCA also reiterates our past support 

9 for retaining carrageenan on the National List. 

10 Carrageenan is a unique stabilizing substance which 

11 infant formula manufacturers to ensure components of 

12 their liquid products remain in suspension so the 

13 nutrients are delivered appropriately during 

14 feeding. The FDA has deemed carrageenan to be safe 

15 for consumption by infants and has a history of safe 

16 use.

17 Additionally, as noted in the NOSB 

18 meeting documents, the Joint FAO/WHO Expert Committee 

19 on Food Additives determined the use of carrageenan 

20 in infant formula and formulas for special medical 

21 purposes for infants does not present any safety 

22 concerns.
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1 As an international expert scientific 

2 committee that reviews the safety of food additives, 

3 INCA encourages the NOSB to consider this critical 

4 objective evaluation when making determinations on 

5 carrageenan safety and whether it should continue to 

6 be used in organic infant formula.

7 Removing carrageenan from the National 

8 List could negatively impact the availability of 

9 liquid organic infant formula products and reduce 

10 organic options available to consumers. Thank you 

11 for your consideration.

12 CHAIR FAVRE: Tom?

13 VICE CHAIR CHAPMAN: Do you know the 

14 percentage of organic liquid versus dry powder in 

15 infant formulas, like market share?

16 MR. RANKIN: I don't know the exact 

17 numbers. But I do know that, essentially, right now 

18 there is one manufacturer of liquid organic infant 

19 formula, and they use carrageenan. I have some other 

20 answers to some questions that were raised for other 

21 people in addition to this as well.

22 VICE CHAIR CHAPMAN: But you don't know 
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1 the market share breakdown?

2 MR. RANKIN: I don't know the breakdown, 

3 no. I would say that I would assume powder outweighs 

4 liquid. But I don't know by how much.

5 CHAIR FAVRE: Harold?

6 MEMBER AUSTIN: Are you aware of any 

7 research being done around this topic? Since 

8 carrageenan was quite an interesting topic in the 2012 

9 review, so I mean, the fact that we're even having 

10 these conversations can't be coming as a surprise to 

11 anybody. Do you know of any research that's been 

12 undergoing to try to find a suitable replacement for 

13 carrageenan for this specific purpose?

14 MR. RANKIN: Well I think one would need 

15 to have a reason to replace it for those reasons. I 

16 think those who use carrageenan know that it is safe. 

17 It is determined to be safe by the relevant regulatory 

18 authorities.

19 JECFA just last year, or in their report 

20 of the last meeting, based on a recent study that was 

21 conducted after the 2010 review by this group to look 

22 specifically at some of the concerns that you all had 
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1 about certain populations, that research was used by 

2 JECFA and included in their conclusion that it's safe 

3 for all populations including infants.

4 So I don't, unless there is a specific 

5 need to go and replace it, I don't know that there 

6 would be any research at this point to do that.

7 CHAIR FAVRE: I have a quick question for 

8 you. Besides food safety, we also look at things like 

9 necessity or essentiality. So can you speak to that 

10 in regards to infant formula?

11 MR. RANKIN: Sure. So for -- well are 

12 you talking about carrageenan? So carrageenan is a 

13 very unique substance, as some have said and more will 

14 say. It provides specific benefits in terms of how 

15 it functions with the nutrients in the ingredients to

16 deliver the consistent optimal nutrition that infants 

17 need when they're consuming formula.

18 Currently, as carrageenan is, as far as 

19 I know, the only stabilizer that is approved for use 

20 in infant formula, any change by industry to 

21 reformulate a liquid organic infant formula product 

22 to contain something besides carrageenan would need 
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1 to undergo FDA review as part of FDA's new formulation 

2 requirements.

3 So a company would need to identify an 

4 alternative. They would need to do their own testing 

5 on the alternative. They would need to submit that 

6 to FDA as part of a full infant formula review. FDA 

7 would need to review the safety of that ingredient. 

8 FDA would need to review the safety and the 

9 appropriateness of that formula.

10 And then, you know, assumedly if that goes 

11 forward, then the company could begin marketing that 

12 product. Does that answer your question?

13 CHAIR FAVRE: Not really.

14 MR. RANKIN: Okay.

15 CHAIR FAVRE: Sorry.

16 MR. RANKIN: Should -- you want to try 

17 again?

18 CHAIR FAVRE: Well that speaks to, sort 

19 of the fact that a company right now would have to 

20 undergo some pretty arduous machinations to come up 

21 with a new formulation. But that doesn't speak 

22 necessarily to the necessity of the ingredient in the 
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1 product.

2 MR. RANKIN: Okay.

3 CHAIR FAVRE: It goes in the formulation.

4 MR. RANKIN: Okay. I can speak to that 

5 too. So as some have said, carrageenan helps 

6 stabilize ingredients in a product, in a liquid 

7 product. It's very important for infant formula. 

8 Infant formula, infants, that's basically, if you're 

9 receiving the infant formula, it's pretty much the 

10 sole source of nutrition. So that's all they're 

11 receiving.

12 So it's important that that nutrition is 

13 delivered appropriately. Obviously carrageenan 

14 helps stabilize the product, helps aid in the 

15 nutrition delivery.

16 There are some minerals, in my 

17 understanding, which if you don't have carrageenan, 

18 and it separates and they fall to the bottom, that they 

19 will not be able to be necessarily shaken back into 

20 suspension.

21 I think calcium is an example. We all 

22 know how important calcium is. It's my understanding 
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1 if calcium -- if carrageenan is not in the product and 

2 the calcium sinks to the bottom for a long period of 

3 time, which these liquid infant formula products 

4 especially the ready to feeds, they're on the shelf 

5 for 12 to 15 months.

6 That calcium can form a precipitate at the 

7 bottom of the container. And if it's shaken up, it 

8 may not come back into suspension. Or it may not 

9 properly come back and stabilize as it would with 

10 carrageenan. It's just a very unique material for 

11 which not a lot of other products do the same thing.

12 CHAIR FAVRE: Yes, that's what I was 

13 hoping to get an answer to. Thank you. Tom, you had 

14 a question?

15 VICE CHAIR CHAPMAN: I may not phrase 

16 this correctly. So we may have to go back and forth 

17 real quick on it. But I get that it's essential to 

18 keep liquid formulas in suspension. Is there 

19 applications where liquid formula is necessary over 

20 a dry formula where it's not the market preference?

21 MR. RANKIN: It's a consumer preference. 

22 Some parents would rather not use water or have to buy 
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1 bottled water or use tap water. There's all kinds of 

2 reasons. Convenience. My children, we used liquid 

3 formula sometimes when we were traveling just because 

4 it's a lot easier. It just provides some added 

5 conveniences, and it's an option.

6 VICE CHAIR CHAPMAN: So it's a 

7 convenience of market? There's no other, there are 

8 no medical reasons --

9 MR. RANKIN: Well --

10 VICE CHAIR CHAPMAN: -- socioeconomic 

11 reasons, no other --

12 MR. RANKIN: There are some conditions 

13 and some indications in the hospital, maybe in the 

14 NICU where you have a premature infant, where a 

15 healthcare provider would rather not a premature 

16 infant consume powder infant formula. Just because 

17 of mixing it and all the things that one needs to do 

18 to ensure that it's safely prepared.

19 So liquid infant formula would provide 

20 less steps in terms of preparing the product where you 

21 have an immunocompromised patient who depends on it.

22 VICE CHAIR CHAPMAN: Do you know if that 
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1 one organic infant formula is approved for such uses?

2 MR. RANKIN: I would need to check on that 

3 and get back to you.

4 VICE CHAIR CHAPMAN: Thank you.

5 CHAIR FAVRE: Jean?

6 MEMVER RICHARDSON: So I'm not a big fan 

7 of adding synthetics to products, organic products, 

8 just to extend shelf life. So let's just set that one 

9 aside for a minute. Suppose I'm the grandma, and I've 

10 got to go out, and I get the liquid organic formula 

11 for the grandchild.

12 I shake it up really well and feed the kid. 

13 How long does it take for that then to separate so the 

14 infant isn't getting the full nutrition in one gulp?

15 MR. RANKIN: Right. I can't say that I 

16 have done research on how often one would have to 

17 continuously or repeatedly shake the bottle to make 

18 sure that it's not losing suspension. But I would say 

19 probably, based on my general estimate, one would 

20 probably need to shake it a couple times during a 

21 feeding to make sure.

22 And so then, if you have a container 
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1 that's being used for multiple feedings, which those 

2 are available, that would need to be shaken in between 

3 feedings. It would need to be shaken repeatedly a 

4 number of times in between the feedings to ensure that 

5 it's not separating and doing the precipitation that 

6 I've mentioned before. So I think you would need to 

7 do it quite a few times.

8 MEMBER RICHARDSON: So it takes 15 

9 minutes to feed the three month old kid. So you're 

10 saying that I would need to shake it up every five 

11 minutes?

12 MR. RANKIN: I haven't done the research. 

13 There may be a manufacturer --

14 MEMBER RICHARDSON: Well I'm trying to 

15 get a sense of its essentiality.

16 MR. RANKIN: I understand. And there 

17 may be a manufacturer who knows this answer. I don't 

18 know the answer, the specific answer. But I do 

19 believe you would need to shake it.

20 CHAIR FAVRE: Okay. Francis first and 

21 then Lisa.

22 MEMBER THICKE: What did they do before 
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1 carrageenan came on? And how long has carrageenan 

2 been in baby, in infant formulas?

3 MR. RANKIN: There are others in this 

4 room probably who would be able to answer that better 

5 than I. Carrageenan has been used for years, 

6 decades. It provides specific properties that allow 

7 the product to remain in suspension as long as 

8 possible.

9 Before carrageenan, there were other --

10 and this predates me. So I don't even know if there 

11 was liquid product before carrageenan. I assume not. 

12 I assume carrageenan allowed liquid product to be 

13 used. So I don't know that there was anything used 

14 before that.

15 CHAIR FAVRE: Lisa?

16 MEMBER DE LIMA: So help me understand. 

17 With the powdered form that doesn't use carrageenan, 

18 people aren't having to shake that every x amount of 

19 minutes. So why is that different than the liquid 

20 form?

21 MR. RANKIN: Because when you make the 

22 product, and then you dry it, or if you make it, and 
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1 it's dried as you make it, everything is very evenly 

2 distributed. And when you add the water, and you 

3 reconstitute it, it more evenly distributes.

4 When it's already liquid and it's in 

5 suspension, it's much more difficult for it to be kept 

6 that way. And the powder is not sitting on the shelf 

7 for 12 or 15 months in that suspension. It's just, 

8 you're mixing it right away, and it's more freshly 

9 prepared.

10 CHAIR FAVRE: Thank you very much.

11 MR. RANKIN: You're welcome. Can I make 

12 one comment about a previous question to another 

13 commenter?

14 CHAIR FAVRE: Sure, quickly please.

15 MR. RANKIN: There was a question about 

16 the use of carrageenan in another manufacturer's 

17 product. I don't believe that manufacturer -- I 

18 think you all know this, but that manufacturer does 

19 not produce any liquid organic formula products. So 

20 they wouldn't need to use carrageenan.

21 CHAIR FAVRE: Okay. Thank you very 

22 much.
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1 MR. RANKIN: Thank you very much.

2 CHAIR FAVRE: Okay. Next up is Jane Shey 

3 followed by Gwendolyn Wyard.

4 MS. SHEY: Good afternoon. My name is 

5 Jane Shey, and I'm a Policy Associate for the Organic 

6 Farming Research Foundation, a national non-profit. 

7 The Organic Farming Research Foundation works to 

8 foster the improvement and widespread adoption of 

9 organic farming systems.

10 OFRF cultivates research, education, 

11 organic research, education, and federal policies 

12 that bring more farmers and acreage into organic 

13 production. We recognize that research is only one 

14 of many topics under the jurisdiction of the NOSB.

15 We believe research is a foundation upon 

16 which Board decisions are made from use of materials 

17 to biotechnology to crops and livestock. Research 

18 informs and guides most of the issues faced by our 

19 farmers and the organic industry.

20 One year ago, NOSB submitted a list of 

21 research priorities that would support the organic 

22 community. Priorities on this list include, but are 
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1 not limited to, plant disease management, soil 

2 building practices, seed purity from GMO, research 

3 needs, and several livestock topics.

4 OFRF is in the process of finalizing a 

5 national organic research agenda survey with more 

6 than 1,000 farmers from across the U.S. 

7 participating. The needs of these farmers and 

8 ranchers matches the research goals identified by 

9 NOSB.

10 OFRF is in the process of finalizing the 

11 report, which should be released soon. And a copy 

12 will be provided to the NOSB Members. And attached 

13 to my testimony is a summary of the priorities for 

14 research, including education and extension 

15 activities.

16 The top five priorities are soil health, 

17 quality, and nutrient management at 74.5 percent; 

18 weed management, 67 percent; fertility management, 66 

19 percent; nutritional quality, health benefits, and 

20 integrity of organic food, 55 percent; insect 

21 management, 51 percent.

22 With the goal of enhancing the economic, 
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1 environmental, and societal sustainability of 

2 organic farming and ranching, OFRF would like to 

3 highlight the following research priorities based on 

4 the Norris Survey:

5 Soil health and basic practices for 

6 coping with climate variability; increased research 

7 in organic insect pest control especially for new, 

8 invasive insect pests; greater investment in animal 

9 production especially minor species such as sheep, 

10 pigs, and bees. Organic seed and seedling production 

11 is another area that merits greater research 

12 attention.

13 We want to thank the NOSB for their work 

14 in recent years to develop research recommendations. 

15 We do encourage NOSB to work to identify research 

16 needs prior to consideration of NOSB recommendations 

17 so that research can provide -- can better inform 

18 policy decisions or help growers adapt more quickly 

19 to changing regulations.

20 OFRF is committed with the NOSB and USDA 

21 as a partner to represent the needs of the organic 

22 research community and organic farmers.
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1 CHAIR FAVRE: Thank you. Any questions? 

2 Jean?

3 MEMBER RICHARDSON: Just a real quick 

4 one, I probably should have read them. Did you submit 

5 these already in writing?

6 MS. SHEY: Yes ma'am, we did.

7 MEMBER RICHARDSON: Okay. Thank you.

8 CHAIR FAVRE: We are actually going to be 

9 working on this this summer. So it's good timing. 

10 Thank you very much.

11 MS. SHEY: Okay. Thank you.

12 CHAIR FAVRE: I'm sorry. Hold on, don't 

13 leave. Francis?

14 MEMBER THICKE: Well I just wanted to 

15 make a comment to clarify that we appreciate your 

16 research priorities. The NOSB -- people should know 

17 that the NOSB's research priorities are really 

18 restricted to topics that we're working on. We don't 

19 cast the net as wide as you do. And so we should know 

20 that.

21 MS. SHEY: Sure.

22 MEMBER THICKE: Okay.
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1 MS. SHEY: Thank you.

2 VICE CHAIR CHAPMAN: Clarification on 

3 that, is it not topics that we're working on and topics 

4 brought to us by the public?

5 CHAIR FAVRE: Yes. We do have that as an 

6 option.

7 VICE CHAIR CHAPMAN: So these were now 

8 brought to us by the public.

9 MEMBER THICKE: Okay. Well that's 

10 great. I didn't realize that.

11 CHAIR FAVRE: Yes.

12 MEMBER THICKE: Then it's a wider net.

13 CHAIR FAVRE: It is, yes. Thank you.

14 MS. SHEY: Okay. Thanks.

15 CHAIR FAVRE: Okay. Next up is 

16 Gwendolyn Wyard followed by Allison Cooke on deck.

17 MS. WYARD: All right. Good afternoon 

18 Madame Chair, NOP staff, and ladies and gentlemen of 

19 the gallery. My name is Gwendolyn Wyard, and I serve 

20 as the Senior Director of Regulatory and Technical 

21 Affairs for the Organic Trade Association.

22 First I'd like to extend a warm welcome 
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1 to the new Board Members. Congratulations. And I 

2 also want to express my gratitude to each and every 

3 one of you for, I know, the hundreds of hours of 

4 volunteer time you put in. So thank you very much.

5 I'm just going to take a couple minutes 

6 to highlight one of the topics that we submitted 

7 written comments on. You have all of our comments. 

8 My colleague Nate Lewis is going to be addressing some 

9 other issues later this afternoon.

10 But just a couple minutes, I want to 

11 address nutrient, vitamins, and minerals. As we 

12 emphasized in our comments, we agree that the current 

13 annotation is problematic, and a revision is 

14 definitely needed.

15 First and foremost, OTA would like to see 

16 NOP complete rulemaking on this exact issue because 

17 considerable time and stakeholder energy went into a 

18 two year process that led to a 2012 proposed rule that 

19 included an annotation consistent with Option Number 

20 2 of the discussion document.

21 So OTA supports Option 2 for several 

22 reasons. You'll see in our written comments we have 
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1 a slightly tweaked version of that, but it's 

2 essentially the same. The one that we submitted is 

3 just a little bit more concise.

4 We support Option Number 2 because first, 

5 it's certifiable and enforceable. Because the CFR 

6 references in the annotation tie to a black and white 

7 list of vitamins and minerals that anyone can look up.

8 Second, the annotation references a list 

9 of vitamins and minerals that FDA considers to be 

10 essential or required in food and/or infant formula. 

11 And, and this is the biggie, those lists are 

12 consistent with the vitamins and minerals that were 

13 specifically enumerated, reviewed, and approved by 

14 the Board in 1995. Anything that's not on those 

15 lists, the ones that you can look up, must be 

16 petitioned.

17 The third reason we support Option Number 

18 2 is because it's consistent with the intent of the 

19 1995 Board. As OTA's task force determined through 

20 extensive outreach with members that served on the 

21 Board at the time, NOSB was opposed to the helter 

22 skelter addition of nutrients to organic foods.
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1 But they were determined to allow 

2 fortification in certified organic products in 

3 instances where their use was appropriate and the 

4 nutrients had undergone complete NOSB review via the 

5 National List process.

6 And finally the fourth reason that we're 

7 supportive of Option Number 2 is that we do support 

8 the maximum freedom of choice for consumers. And we 

9 believe that organic products should be nutritionally 

10 equal to their conventional counterparts.

11 So in closing on this topic, we hope 

12 NOSB's request for information will provide NOP with 

13 the information needed to move the process forward. 

14 We urge NOP and other stakeholders to communicate to 

15 NOP that completion of this rulemaking should be a 

16 priority.

17 And please everyone join us tomorrow 

18 evening for the reception that's going to be across 

19 the street at the zoo. If you look at the resource 

20 booklets that we have out there, there's information 

21 on the back. And I'll have some cards. Really 

22 looking forward to a networking event that everybody 
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1 is welcome to. So thank you.

2 CHAIR FAVRE: Tom?

3 VICE CHAIR CHAPMAN: So on nutrients, 

4 vitamins, and minerals, your comments point to a 

5 survey as well as SPINS data that shows consumer 

6 increased purchasing of fortified organic products. 

7 But we've had and received comments from non-profit 

8 groups that represent consumer interests that, pretty 

9 much, lobbies to the opposite.

10 How to we rectify that kind of disconnect 

11 of consumer interest or wants related to fortified 

12 products in organics?

13 MS. WYARD: I would have to look at the 

14 data myself and do the side-by-side comparison 

15 because I don't know specifically.

16 VICE CHAIR CHAPMAN: We didn't really get

17 data on the other side. It was more statements.

18 MS. WYARD: Yes. And also I think the 

19 data that we provided in our comments, it is a few 

20 years old. And the data that we were presenting was 

21 really making the point that you can see what 

22 consumers are wanting through the cash register, 
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1 through the purchases that are happening there.

2 So you can look at the sales of fortified 

3 organic food. And that speaks for consumer 

4 preference. And that was our point there. There's 

5 also information that we submitted at the time of the 

6 proposed rule or the comment on the proposed rule, I 

7 think it's included in the interim rule.

8 I think there's a lot of data there that 

9 can be looked at as well that speaks to the sales of 

10 fortified foods.

11 VICE CHAIR CHAPMAN: Thank you.

12 CHAIR FAVRE: Zea?

13 MEMBER SONNABEND: Thank you Gwendolyn. 

14 Diverging just slightly, I'm going to ask you to 

15 clarify your comment on ancillary substances that you 

16 didn't address in your verbal comment. But then I'm 

17 also going to ask Emily Brown Rosen to respond to your 

18 concern about the IRAC lists and things like that.

19 MS. WYARD: So you'd like some 

20 clarification on the concerns that we expressed on the 

21 ancillary substances? Sure. So our comments on the 

22 ancillary substances, just a quick review, we think 
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1 that all parts of the proposal are needed. We support 

2 the definition of ancillary substances. We support 

3 the review procedure that was outlined.

4 We've always agreed that ancillary 

5 substances do need to be reviewed. We absolutely are 

6 supportive of the template, the information that was 

7 put in there for the creation of an affidavit so that 

8 certifiers, material review organizations, and 

9 industry can make these compliance decisions on a 

10 day-to-day basis.

11 Our concern had to do with the baseline 

12 criteria that was passed in the April 2013 

13 recommendation that wasn't included in the criteria 

14 that was in this proposal. We just wanted to make 

15 sure that, at the end of the day, all of that criteria 

16 would come together so that that criteria then would 

17 be transferred to Example 2 in affidavit.

18 So if the intent is for all of that to come 

19 together, that's great. We recommended taking the 

20 proposal back to subcommittee and putting one out in 

21 the fall that would put that all there together just 

22 to be absolutely certain. Does that answer your 
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1 question as to the concern?

2 MEMBER SONNABEND: What I was more 

3 concerned about, because I will explain the 

4 difference between those two sets of criteria in the 

5 presentation on Wednesday, but more your concern 

6 about IARC lists and the NTP lists involving ethanol 

7 and red meat and how that you construed that as, 

8 perhaps, not being allowed.

9 MS. WYARD: Okay. Sorry. So I told you 

10 about that one.

11 MEMBER SONNABEND: But I mean, I'm glad 

12 to hear the other thing. But that will be addressed 

13 on Wednesday.

14 MS. WYARD: Okay. Super. So the list 

15 of known and probable carcinogens, on that list I 

16 found ethanol and ethyl alcohol and red meat. And I 

17 heard from several members expressing concern that 

18 they're on that list.

19 Ethanol is quite commonly used as an 

20 ancillary substance. There's organic ethanol that's 

21 used for making flavors, et cetera, et cetera. So it 

22 was how to reconcile something such as ethanol that 
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1 would be on that list of probable or known 

2 carcinogens. Would that completely eliminate then 

3 its allowance as an ancillary substance?

4 And we, in looking at it, felt like the 

5 whole context wasn't being taken into consideration. 

6 That just because something was on that list, you had 

7 to then look at the overall exposure that one would 

8 have to that particular substance on the list.

9 I mean I think we've probably all here in 

10 this room consumed red meat or alcoholic beverages 

11 sometime over the past week, maybe not.

12 MEMBER SONNABEND: Well before I ask 

13 Emily to comment, what is red meat an ancillary 

14 substance in? And shouldn't vegetarians be warned 

15 about that?

16 MS. WYARD: That was just to express a 

17 point, that just because it's on the list doesn't 

18 guarantee that you're going to get cancer.

19 MEMBER SONNABEND: Emily, could you talk 

20 about the alcohol, the ethanol?

21 MS. BROWN ROSEN: Yes. I think I need to 

22 look back at the IR list again and the other list 
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1 again. But I think you could somehow -- basically 

2 you're looking at the use as an ancillary. And that 

3 list is not restricted to that type of use.

4 So I think there might be some wording 

5 ways to get around that. I'm not, you know, but we'd 

6 have to look at that a little more closely.

7 MEMBER SONNABEND: I thought you 

8 mentioned to us in subcommittee that it was for 

9 alcoholic beverages only was how it was listed on the 

10 cancer list. And therefore, as an ancillary it 

11 wouldn't be used in alcoholic beverages. It would be 

12 used in other things.

13 VICE CHAIR CHAPMAN: That's my 

14 understanding of the list. It says ethanol for 

15 alcoholic beverage.

16 MS. BROWN ROSEN: Okay.

17 VICE CHAIR CHAPMAN: So if that's the 

18 annotation, would we consider that, if it's being used 

19 as an ancillary, would we consider that for alcoholic 

20 beverage? I assume not.

21 MS. BROWN ROSEN: No. No, because 

22 you're looking at its use as an ancillary. We maybe 
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1 have to tighten up the language a little bit to make 

2 the use indicated there.

3 MS. WYARD: And that was our comment, 

4 that there might need some additional guidance to go 

5 with it. But we completely support the approach that 

6 you're taking. That you'd be looking at the, you 

7 know, the health impacts. That's critical.

8 MEMBER SONNABEND: If you do find red 

9 meat in something, please let some of us know who don't 

10 eat red meat.

11 MS. WYARD: I'll be the first to let you 

12 know. Thank you very much.

13 CHAIR FAVRE: Okay. Next up is Allison 

14 Cooke followed by Jeff Noland on deck.

15 MS. COOKE: Okay. Good afternoon. My 

16 name is Allison Cooke and I'm representing the 

17 International Food Additives Council. IFAC is a 

18 global association representing manufacturers of 

19 food ingredients.

20 IFAC strongly supports relisting 

21 carrageenan on the National List at 205.605(a). Like 

22 other seaweed derivatives, carrageenan utilizes mild 
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1 processing and is correctly characterized as a 

2 non-synthetic substance.

3 Since the last sunset review, multiple 

4 rigorous scientific studies have been published that 

5 demonstrate its safety. Perhaps the most 

6 significant, in 2015, the Joint FAO/WHO Expert 

7 Committee on Food Additives published their 

8 evaluation of carrageenan for use in infant formula 

9 and formulas for special medical purposes.

10 JECFA is an international independent 

11 expert scientific committee which reviews the safety 

12 of food additives. Ultimately JECFA determined that 

13 carrageenan is safe for use in infant formula and 

14 formulas for special medical purposes.

15 The report also concluded that it is 

16 unlikely to be absorbed in the human gut. 

17 Carrageenan offers organic formulators with a number 

18 of unique properties that are not available from other 

19 hydrocolloids or thickening agents.

20 One of these properties is its unique 

21 protein interaction which helps prevent separation of 

22 key components even at very low usage levels. It is 
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1 also known for its gelling, suspension, and 

2 thickening abilities across many temperature and pH 

3 ranges.

4 Reclassifying or delisting carrageenan 

5 when other suitable organic alternatives do not exist 

6 would threaten consumer access to many organic 

7 products and limit innovation.

8 Finally, it is important to note that 

9 seaweed cultivation for carrageenan production helps 

10 create valuable marine habitats and improves water 

11 quality, a net positive impact on the environment. 

12 Such cultivation is also commonly practiced by small 

13 family farmers and provides a sustainable livelihood.

14 For these reasons, IFAC strongly supports 

15 relisting carrageenan on the National List at 

16 205.605(a). IFAC also supports the continued 

17 listing of silicon dioxide as a synthetic listed on 

18 the National List at 205.605(b).

19 Silicon dioxide is an essential and 

20 irreplaceable ingredient that functions as the 

21 defoamer in a variety of applications which are 

22 critical to the production of organic foods. IFAC is 
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1 unaware of any suitable organic alternatives.

2 IFAC also notes that the revised 

3 annotation for silicon dioxide effective November 3, 

4 2013 already provides for the continued use of the 

5 defoamer under certain circumstances.

6 Due to its versatility, IFAC believes 

7 that delisting silicon dioxide will have a 

8 significant negative impact on organic products. 

9 And we urge the NOSB to relist silicon dioxide at 

10 205.605(b) with the current annotation.

11 Finally, IFAC supports the continued 

12 listing of cellulose at 205.605(b). While the 

13 production of non-synthetic cellulose is technically 

14 possible, no commercial sources are currently known. 

15 IFAC is also unaware of any organic cellulose 

16 currently available.

17 IFAC notes that the NOSB has asked for 

18 information on possible alternatives for what limited 

19 use is permitted under the National List annotation. 

20 To date, IFAC has been unable to identify a suitable 

21 organic alternatives for the important functions of 

22 filtering aid and anti-caking agent nor suitable 
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1 substitutions in casings.

2 As a result, IFAC supports the relisting 

3 of cellulose for use in regenerative casings, as an 

4 anti-caking agent and filtering aid and would not 

5 object to the addition of powder to the listing. 

6 Thank you.

7 CHAIR FAVRE: Any questions? Tom?

8 VICE CHAIR CHAPMAN: On carrageenan, you 

9 said its removal would threaten the access to many 

10 organic products. We've had liquid infant formula 

11 identified. What other products are solely 

12 available with carrageenan?

13 MS. COOKE: So I believe the 

14 representative from IDFA mentioned that it's used in 

15 a lot of dairy products. It's in different matrices 

16 there. So creams, ice creams, yogurts, other dairy 

17 products it's used.

18 VICE CHAIR CHAPMAN: And none of those 

19 are available without carrageenan?

20 MS. COOKE: I mean I believe there might 

21 be alternatives. But I don't know of organic ones 

22 that are available. There could be.
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1 VICE CHAIR CHAPMAN: You're not aware of 

2 organic ice creams without carrageenan in them?

3 MS. COOKE: I don't know all the organic 

4 ice creams available out there so I cannot answer that 

5 truthfully.

6 VICE CHAIR CHAPMAN: Okay. So if I could 

7 reinterpret what you said, there are organic products 

8 on the marketplace that use carrageenan that could be 

9 threatened. But besides liquid infant formula, 

10 you're not aware of any other classes of products that 

11 solely use carrageenan? Like ice cream, that it's in 

12 100 percent of the ice creams out there.

13 MS. COOKE: I know there are others 

14 talking tomorrow on carrageenan. So perhaps they 

15 could provide more information on the specific types 

16 of products that it would be used.

17 VICE CHAIR CHAPMAN: Okay. But you 

18 don't have any more information on that statement you 

19 made?

20 MS. COOKE: Not at this time.

21 VICE CHAIR CHAPMAN: Thank you.

22 CHAIR FAVRE: Jean?
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1 MEMBER RICHARDSON: I'm getting the look 

2 from the Chair. You say that most of the carrageenan, 

3 or I'm interpreting you, is most of the carrageenan 

4 is actually farmed. Is that what you're suggesting?

5 MS. COOKE: Correct.

6 MEMBER RICHARDSON: So do you have a 

7 percentage?

8 MS. COOKE: I don't have that off hand. 

9 I could follow up and --

10 MEMBER RICHARDSON: It would be great if 

11 you could. That would be helpful.

12 MS. COOKE: Okay. Yes.

13 MEMBER RICHARDSON: Thank you.

14 CHAIR FAVRE: Thank you very much. Next 

15 up is Jeff Noland followed by Richard Mathews on deck.

16 MR. NOLAND: Hi there. I'm Jeff Noland. 

17 I'm the Managing Director of EnergyWorks BioPower. 

18 And I want to thank you guys for the opportunity to 

19 speak today regarding our petition to modify the ash 

20 from manure burning prohibition.

21 I've read the Crop Subcommittee 

22 recommendation and I am surprised that it basically 
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1 ignores our petition. I am responding to that 

2 recommendation and we look forward to your fair 

3 consideration and dialogue.

4 First, our petition highlights the big 

5 difference between open burning and a controlled 

6 thermochemical reaction. It's true that open 

7 burning wastes nutrients and causes air pollution. 

8 So it is rightly prohibited.

9 Our proposal specifies a process that 

10 selects mineral nutrients, retains fixed carbon, and 

11 operates under an air permit. The result is a 

12 non-synthetic ingredient that lets a crop fertility 

13 program proceed with no health and environmental side 

14 effects.

15 The logic gap in the recommendation is the 

16 premise that since some of our manure comes from a 

17 CAFO, it disqualifies the new practice from being 

18 considered. Suppose that the manure came from 

19 organic farmers. Would that qualify our ingredient? 

20 Is fresh manure from CAFOs prohibited in organic 

21 farming? No it's not.

22 The National List encourages sustainable 
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1 non-synthetic materials. So clearly, the manure's 

2 origin should have nothing to do with the prohibition. 

3 So the answer to the three evaluation criteria should 

4 clearly be yes.

5 On impacting humans and the environment, 

6 the no boxes being checked are only true if a process 

7 like ours is not solving CAFO manure challenges.

8 Well our petition is not about a single 

9 facility. The agreement is to the overwhelmingly 

10 positive benefits of our process to the Chesapeake 

11 Watershed is broad, to environmentalists, the EPA, 

12 and the states around us who benefit from improved 

13 water quality.

14 On the essential and available criteria, 

15 there are two points. The first is that our material 

16 is a tricalcium phosphate. The National List 

17 currently allows synthetic calcium phosphates that 

18 originate from mined rock, a byproduct of which is 

19 large radioactive tailings piles that are regulated 

20 by EPA. So alternatives are available but they hurt 

21 the environment.

22 Second, manure can be substituted but 
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1 that the risk of nutrient pollution and health issues 

2 which the subcommittee acknowledges in objection to 

3 CAFOs. As we deal with avian influenza, storing, 

4 transporting, and broadcasting manure even from 

5 smaller producers is a major risk.

6 On compatibility and consistency, the 

7 counter argument is the same as that for humans and 

8 the environment. If the NOP wants to promote natural 

9 and healthy food production practices, then the 

10 answer to the first criteria is absolutely yes.

11 In fact, the presence of an effective 

12 manure management plan minimizes a CAFO's 

13 environmental impact. So by any yardstick, a process 

14 that recycles material, minerals, generates 

15 renewable energy, and tackles the top pollution issue 

16 in the Chesapeake Bay is unsustainable.

17 So finally, manure is in abundance. It 

18 is the number one water pollutant in the Mid Atlantic. 

19 It makes no sense to limit manure derived 

20 non-synthetics. With repeated reference to past 

21 decisions, the subcommittee ignores the potential for 

22 innovation.
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1 In this case, that innovation enables 

2 wider scale adoption of non-synthetics. So the 

3 subcommittee's recommendation should be rejected and 

4 a well written exception to the ash from manure 

5 burning prohibition accepted. Thank you.

6 CHAIR FAVRE: Do we have any questions? 

7 Thank you. We appreciate your passion on the 

8 subject.

9 MR. NOLAND: You bet.

10 CHAIR FAVRE: Next up is Richard Mathews 

11 followed by Zareb Herman.

12 MR. MATHEWS: Good afternoon. My name 

13 is Richard Mathews. I'm the Executive Director of 

14 the Western Organic Dairy Producers Alliance. The 

15 dairy producers in the western region produce or raise 

16 over half of the dairy animals and produce over half 

17 of the milk.

18 We are in support of the hypochlorous acid 

19 as produced through electrolyzed process. That is an 

20 important point that it has to be the electrolyzed 

21 method because that is only using water and salt.

22 Other forms of hypochlorous acid are 
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1 produced using other chemicals that you have not 

2 reviewed. And therefore, it needs to be annotated in 

3 a way that makes it clear that it's coming from the 

4 process of electrolyzing the brine.

5 The second issue that I would like to 

6 bring up is that we've heard a lot today about 

7 hydroponics, aquaponics. I think I heard aeroponics 

8 one time. And I talked to Dr. Tollefson and she 

9 indicated that they had not considered fodder. 

10 Fodder produced through a fodder growing system that 

11 is indoors that uses water and alfalfa seed to raise 

12 fodder for dairy animals as a replacement for grain.

13 Now I've heard through the grapevine that 

14 that would be considered as a sprout. I'm having 

15 trouble envisioning that fodder several inches tall, 

16 green as the grass in my yard with white roots is going 

17 to be considered a sprout. And so we need to be real 

18 clear there whether or not you're going to take away 

19 fodder growing systems from dairy farmers. And I 

20 hope that's not the case.

21 The other thing is parasiticides. We at 

22 WODPA believe that it is only for use in an emergency 
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1 situation. We want to see that continue. We would 

2 like to see something new in that, specifically that 

3 you prohibit off label uses of parasiticides. And I 

4 can tell you that my farmers are very upset about the 

5 concept of two days for Moxidectin and fenbendazole.

6 And in quickly closing, to say that in the 

7 case of the animal welfare, the dairy farms are 

8 concerned throughout the nation. And to say that 

9 well, it's going to be okay because that's not quite 

10 what we meant to do and give out some explanation or 

11 a guidance.

12 We all have to remember explanations and 

13 guidance are not regulatory text. Regulatory text 

14 will be interpreted and enforced. Just think of one 

15 thing, the pasture rule. Why did we have the pasture 

16 rule? Because the text said one thing --

17 CHAIR FAVRE: I'm sorry, we're going to 

18 have to cut it off there.

19 MR. MATHEWS: Okay.

20 CHAIR FAVRE: We're past time.

21 MR. MATHEWS: Well I'm really done. I 

22 just wanted to make the point that the text said one 
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1 thing, the preamble said something else, preamble 

2 never follows through in the code of federal 

3 regulations. Thank you.

4 CHAIR FAVRE: We might have a Board 

5 Member ask a question that'll give you a chance to 

6 finish out. Do we have any questions? Jean?

7 MEMBER RICHARDSON: Yes. I read your 

8 comments with great care and took them very seriously. 

9 And compared data and so on to verify, you know, what 

10 it is and how we're approaching it.

11 The first thing I want to do is absolutely 

12 assure you that there is no change to the emergency 

13 only use in this recommendation. That's always been 

14 the case and that continues to be the use.

15 And indeed, one of the things that we will 

16 be taking up following this meeting based on public 

17 comments such as yours, is to really fully understand 

18 what the definition is of emergency use in order that 

19 it's fully clarified. So I appreciate your comments 

20 on that and others that have done the same thing.

21 The other thing regard the off label use, 

22 I don't believe that we -- and Emily can perhaps 
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1 correct me if I'm wrong here. I'm not brilliant on 

2 everything. I don't believe that we could prevent 

3 the off label use. And there is no intent at all in 

4 what we drafted to encourage off label use.

5 Off label use, as you know, is really a 

6 veterinarian relationship discussion with the 

7 farmer. And based on animal size, et cetera, breed 

8 of animal, ruminant, you know -- so that's the kind 

9 of thing that the veterinarian has to make a decision 

10 on.

11 But we are not in any way pushing off label 

12 use at all. But at the same time, we can't, it's not 

13 something we're able to prevent. I don't know, 

14 Francis, if you want to add something there.

15 CHAIR FAVRE: Francis?

16 MEMBER THICKE: Well thank you Richard 

17 for your comments. I'm just, my question is, were 

18 there sheep and goat dairy producers in your WODPA 

19 discussion? Or was it all dairy cattle?

20 MR. MATHEWS: It's all dairy cattle.

21 MEMBER THICKE: Okay.

22 CHAIR FAVRE: Emily?
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1 MEMBER OAKLEY: Could you elaborate on 

2 the concern for the two day withholding period please?

3 MR. MATHEWS: Well there are meat 

4 withholdings which, if you look at at least one of the 

5 NADAs for Ivermectin as an example -- well actually 

6 for all of those. For Ivermectin, it says that meat 

7 isn't a good measure. And the other ones are using 

8 meat as measures.

9 Now I understand that when the animal is 

10 treated, it loses its meat status. But to say that 

11 you've got milk tolerances would zero withholds. And 

12 then you, apparently, have an arbitrary two day. 

13 We're not convinced that there's not going to be 

14 parasiticides in the milk.

15 And the last thing we need is a scandal 

16 caused by the presence of parasiticide in milk. Our 

17 consumers expect that the milk not have antibiotics, 

18 that it not have growth hormones, or any other 

19 material such as a parasiticide.

20 CHAIR FAVRE: Jean?

21 MEMBER RICHARDSON: I take your concerns 

22 very seriously. And if I have your email address, 
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1 what I could do is I can email to you the precise way 

2 in which we got the two day. And FARAD database and 

3 all those other places, so you can see the scientific 

4 basis. And you know, the FARAD database science that 

5 went into developing the data.

6 And we are, as you know, not proposing to 

7 -- we're proposing to use double the FARAD. So it's 

8 still low, you know, compared with anything else. I 

9 mean, I believe the science is very good to support 

10 what it is that we're recommending.

11 Furthermore, Ivermectin, we're going to 

12 be petitioning to remove Ivermectin. We, all of us, 

13 were fully in accord at our last year, as you know, 

14 to remove it then. We wanted to just give it a bit 

15 longer. And we will be moving to remove it because 

16 of the dung beetle impact, apart from anything else. 

17 And we're not changing the Ivermectin 

18 recommendations.

19 So if you email me, or I'll provide you 

20 with that science foundation.

21 MR. MATHEWS: I'll be glad to give you my 

22 email address.
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1 MEMBER RICHARDSON: Thank you.

2 MR. MATHEWS: And just to follow up on 

3 some of your comments, we -- well we'll just talk about 

4 it later.

5 CHAIR FAVRE: Yes.

6 MR. MATHEWS: Okay.

7 CHAIR FAVRE: Thank you very much. We 

8 appreciate it. Next up is Zareb Herman followed by 

9 Troy Aykan.

10 MR. HERMAN: My name is Zareb Herman. I 

11 am a nutritionist with the Hain Celestial Group. My 

12 topic is the vitamins and minerals discussion 

13 document.

14 While most Americans consume an abundance 

15 of calories, the National Health and Nutrition 

16 Examination Survey shows that millions of Americans 

17 consume inadequate levels of one or more vitamins and 

18 minerals including iron, calcium, magnesium, 

19 Vitamins A, C, D, E, B6, folate, thiamine, and others.

20 These low intakes would be much worse if 

21 food was not fortified. As an example, if food was 

22 not fortified with folic acid, 88 percent of the 
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1 population would consume less than the estimated 

2 average requirement. But due to fortification, the 

3 percentage has dropped to just 11 percent and 

4 thousands of children have been spared from serious 

5 birth defects.

6 As a nutritionist who cares about the 

7 health of others, I cannot support an annotation that 

8 limits the fortification of organic foods Or forces 

9 organic products into the inferior made with organic 

10 category. Making organic food less nutritious and 

11 nutritionally inferior to conventional food is 

12 irresponsible.

13 The public health consequences would hurt 

14 the health of consumers. And the loss of sales would 

15 hurt the organic industry. For these reasons, I 

16 generally support Option 2, Annotation 4.

17 But I prefer a more concise annotation 

18 that was proposed by the Organic Trade Association 

19 that reads, vitamins and minerals identified as 

20 essential in 21 CFR 101.9 or as required for infant 

21 formula by 21 CFR 107.100 or 107.10.

22 The substantial sales of organic foods 
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1 show that organic food consumers want these products. 

2 If some consumers do not wish to purchase such 

3 products, the solution is simple. Don't buy them.

4 As an example, I purchased this fortified 

5 rice beverage that contains calcium and Vitamin D 

6 because I am lactose intolerant and don't drink milk. 

7 I like to get the nutrients that are normally obtained 

8 from milk. But if another consumer does not want the 

9 added nutrients, he or she can purchase this product 

10 that is not fortified.

11 Please do not limit the fortification of 

12 organic foods. Thank you.

13 CHAIR FAVRE: Any questions? Thank you 

14 very much. Next up is Troy Aykan followed by Jason 

15 Whitcher on deck.

16 MR. AYKAN: Good afternoon. My name is 

17 Troy Aykan. I'm a food scientist and a lawyer with 

18 the Hain Celestial Group, one of the largest producers

19 of organically produced items in the world. I also 

20 teach courses in food laws and regulations at several 

21 universities in Southern California.

22 We strongly support the continued listing 
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1 of silicon dioxide. The current annotation allows 

2 for the use of silicon dioxide when organic rice hulls 

3 are not effective. In some food processing 

4 applications, in fact, rice hulls are an acceptable 

5 substitute for silicon dioxide.

6 However, rice hulls are not the same 

7 substance as silicon dioxide. And rice hulls do not 

8 have the same functionality as silicon dioxide in all 

9 applications. Some of our organic flavor suppliers 

10 utilize silicon dioxide to prevent caking in dry 

11 flavors.

12 A number of our suppliers of organic spice 

13 and seasoning blends use silicon dioxide because rice 

14 hulls cannot prevent caking in these sticky 

15 ingredient blends. Silicon dioxide is extremely 

16 important to ensure uniform mixing of our dry blends 

17 and the uniform application of our seasoning blends 

18 to our snack products.

19 We urge the Board to keep silicon dioxide 

20 on the National List. Thank you.

21 CHAIR FAVRE: Thank you very much. Any 

22 questions? Thank you very much.
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1 MR. AYKAN: Thank you.

2 CHAIR FAVRE: Next up is Jason Whitcher 

3 with Jay Feldman on deck.

4 MR. WHITCHER: There's a small group, 

5 there's a group of farmers proposing that 

6 containerized growing should not be permitted to use 

7 the USDA organic seal. What they are suggesting is 

8 that if a plant is grown in a bucket, bag, trough, or 

9 any other type of container, the production cannot be 

10 considered organic.

11 Does this mean they feel or believe the 

12 house plants I have in my home are synthetic and not 

13 organic because they're in clay pots? Hopefully not 

14 or this would be viewed as absurd. However, this is 

15 no more absurd than the suggestion that containerized 

16 growing cannot be organic.

17 Containerized growing is a sustainable, 

18 viable, and vital method of organic production that 

19 provides an environmentally responsible way to give 

20 the U.S. consumers the organics that they want.

21 Mastronardi Produce distributes organic 

22 cucumbers, tomatoes, and peppers from our own farms 
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1 as well as grower-partner farms. We've been doing so 

2 for over eight years under the USDA organic seal.

3 According to Nielsen Perishables Group 

4 data, year over year volumes are up on organic 

5 cucumbers by 29 percent with 39 percent of the volume 

6 coming from hot houses, by 39 percent on organic 

7 peppers with 43 percent of the volume coming from hot 

8 houses. And volume is up 19 percent on organic 

9 tomatoes with 38 percent of the volume coming from hot 

10 houses.

11 Now that container growers have grown the 

12 market over the last ten years, this notion to 

13 decertify containerized growing would inhibit the 

14 growth, supply, and consumption of organic produce. 

15 And increase pricing to the financial benefit of the 

16 remaining producers and the detriment of the American 

17 public.

18 USDA organic regulations mandate that we 

19 respond to site specific conditions by integrating 

20 cultural, biological, and mechanical practices that 

21 foster the cycling of resources, promote ecological 

22 balance, and conserve biodiversity. Are soil 
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1 erosion, nutrient runoff, water consumption no longer 

2 issues in the United States?

3 To illustrate the environmental 

4 sustainability of containerized growing, the 120 

5 acres of hot house production in the Mastronardi 

6 network would require over 1,000 acres of open field 

7 production and approximate ten times the amount of 

8 water.

9 The 120 acres that Mastronardi produces 

10 and distributes is only a small part of the hot house 

11 production of organics, less than five percent 

12 actually.

13 Even if we argue it is five percent of the 

14 production, this means that the removal of these 

15 organics in the marketplace would require over 20,000 

16 acres of land and all of the excess natural resources 

17 required to farm without using containerized methods.

18 That's just in tomatoes, cucumbers, and 

19 peppers. Are we willing to sacrifice all of this land 

20 and add to nutrient runoff, soil erosion, and water 

21 consumption issues that already exist?

22 The objective of the NOSB and the USDA 
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1 should be to ensure that the American public is being 

2 protected and getting what they expect when 

3 purchasing products with the USDA organic seal.

4 The research of the Organic Trade 

5 Association demonstrates that containerized 

6 production of organics meets or exceeds consumer 

7 expectations for organically grown produce. And 

8 that's the only opinion that should matter. Thank 

9 you.

10 CHAIR FAVRE: Any questions? Thank you 

11 for your comments.

12 MR. WHITCHER: Thank you.

13 CHAIR FAVRE: Next up is Jay Feldman with 

14 Michael Polletta on deck. Hi Jay.

15 MR. FELDMAN: Hi. Good afternoon. 

16 Welcome to all new Board Members. And Harold, it's 

17 great to see you back and not have to listen to your 

18 disembodied voice. So we're happy about that.

19 Organic is great and we have to make sure 

20 that it stays that way. So I'm going to spend a lot 

21 of my time today talking, all of it, on the PPM.

22 The NOSB has, through its policies and 
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1 procedures, created an opportunity to discuss 

2 problems under the banner of incentivizing continuous 

3 improvement. The PPM, as you know, outlines the 

4 decision making process of the Board that has 

5 historically facilitated broad public discussion.

6 Revisions to the PPM have been made since, 

7 have not been made since 2012. As you all know, the 

8 PDS or the Policy Development Subcommittee was 

9 eliminated by the NOP in 2013. And the Board was told 

10 that USDA has complete authority over the PPM.

11 I realize that's changed now but you must 

12 ensure that NOP does not, at its discretion, limit the 

13 ability of the Board, your ability to fulfill a 

14 statutory duty to recommend materials and clearly 

15 advise the Secretary on "any other aspects of the 

16 implementation" of the Act.

17 Work plans, the Board must fulfill its 

18 statutory responsibility and comply with the law. If 

19 it does not control its work plan, it cannot do this. 

20 The Board was created to keep organic ahead of the 

21 curve and was given independence to do this. This 

22 creates a healthy push and pull with USDA that has 
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1 served organic well as it grows to a $40 billion 

2 industry.

3 We are not supporting farmers when we take 

4 actions that reduce consumer confidence in the 

5 organic label. Consumers want to know that the 

6 process by which decisions are made are fair.

7 Do not feel constrained when it comes to 

8 following the law if there is a need for restricting 

9 material uses. The marketplace will encourage 

10 ingenuity and that has gotten us to this point. And 

11 we have instituted organic systems that nurture soil 

12 biology and nutrient cycling that we once were told 

13 was not feasible in commercial agriculture.

14 Do not do away with the incentives the 

15 Board has created over time for open participation of 

16 all stakeholders including minority views. We will 

17 see, if you do that, we will see others filling a gap 

18 such as non-GMO labeling and pastured eggs and no 

19 carrageenan.

20 So over time, the Board has adopted a lot 

21 of provisions including an amendment to the PPM for 

22 annotations. It has unanimously adopted a docket. 
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1 All of these things have established a tone of 

2 openness.

3 So it's your job, we believe, through the 

4 PPM and its amendments to ensure that this openness 

5 is retained. Do not confuse collaboration with 

6 concurrence. You have an independent responsibility 

7 to establish positions that ensure public 

8 involvement. Thank you.

9 CHAIR FAVRE: Thank you Jay.

10 MR. FELDMAN: Thank you.

11 CHAIR FAVRE: Any questions? Zea?

12 MEMBER SONNABEND: Hi Jay.

13 MR. FELDMAN: Hey.

14 MEMBER SONNABEND: Sorry to change the 

15 subject. One of the things that is on our work plan 

16 because you put there is the contamination of farm 

17 inputs. What would you suggest should be our next 

18 steps to take a look at that? Because we haven't 

19 gotten a very firm grip on it since you left. But 

20 Harriet has agreed to take it over.

21 MR. FELDMAN: Thank you. Thank you 

22 Harriet. Well as you know, the public has seen a 
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1 discussion document on this topic. It's one of the 

2 examples, by the way, of the Board staying ahead of 

3 the curve. And is a positive example of a work plan 

4 item being approved by NOP to engage the community 

5 with this.

6 I think the compost issue is a place to 

7 begin in terms of identifying a procedure by which the 

8 Board affirms a review process that can be carried out 

9 by certifiers, by inspectors to ensure a level of 

10 compliance.

11 And that, through that process, we go back 

12 and review the guidance on bifenthrin and evaluate 

13 that whole process of allowed residues. And how we 

14 go through a process that ensures that when consumers 

15 ask, well do we know what's in our compost, we have 

16 a solid process that we can point to that we feel good 

17 about. And that we have evaluated fully. So I hope 

18 that answers your question.

19 I think that's a good starting point, a 

20 jumping off point for issues around water 

21 contamination, for issues around acceptable residues 

22 in materials that make their way into organic 
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1 production.

2 MEMBER SONNABEND: Okay. I'm not sure 

3 we can look at that compost guidance while it's being 

4 challenged in court. But once that is past, maybe. 

5 But thanks.

6 MR. FELDMAN: Okay.

7 CHAIR FAVRE: Any other questions?

8 MR. FELDMAN: Thank you.

9 CHAIR FAVRE: Thank you Jay. Next up is 

10 Michael Polletta followed by Jim Crawford on deck.

11 MR. POLLETTA: Greetings and good 

12 afternoon. My name is Michael Polletta, Esquire and 

13 I'm the Legal and Regulatory Specialist at Vermont 

14 Soap in Middlebury, Vermont, U.S.A. I'm here today 

15 to represent the interest of organic soaps.

16 For the last 13 years, Vermont Soap has 

17 been a certified organic processor of body, pet, and 

18 home cleaning products that make products made both 

19 under our own label and for a number of independent 

20 labels.

21 Vermont Soap supports the relisting of 

22 potassium hydroxide with the following comments. We 
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1 ask for a clarification that potassium hydroxide is 

2 a processing aid rather than an ingredient for the 

3 purpose of organic soap production.

4 According 7 CFR 205.2, the NOP defines an 

5 ingredient as a substance used in preparation of a 

6 product that is still present in the end result. 

7 Processing aid is defined as, relevantly, a substance 

8 added for a functional effect which is not present in 

9 the finished product at a significant level and has 

10 no technical or functional effect on the product.

11 We believe that potassium hydroxide's 

12 role in soap making should be clarified is that as a 

13 processing aid because it is not present in the final 

14 product except in incidental, non-functional trace 

15 amounts.

16 Potassium hydroxide crystallizes organic 

17 oils into organic soap. Chemically speaking, one 

18 triglyceride oil chain is joined to three soap crystal 

19 molecules and a glycerine molecule leaving behind no 

20 potassium hydroxide. Meaning it poses no threat to 

21 human or environmental health.

22 To put it simply, potassium hydroxide 
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1 aids in processing oils, which make you dirty, into 

2 soap, which makes you clean. According to the NOP, 

3 that means for the process of making soap, potassium 

4 hydroxide which is not found in nor has an effect on 

5 final product, meets the definition of a processing 

6 aid which is not counted against a products organic 

7 percentage.

8 However, as things currently stand, 

9 potassium hydroxide is counted in the ingredients 

10 that make up soap despite not appearing in organic 

11 soap. This keeps it from passing the key 95 percent 

12 organic mark.

13 Instead, all organic soap products must 

14 state made with organic oils despite the fact that 

15 saponified organic oils are the only ingredient found 

16 in this product.

17 Organic soap is part of the organic 

18 family. It may not be a food product, but it is a 

19 daily part of life that organically minded consumers 

20 both desire and deserve. If the body is a temple, not 

21 only should we be concerned with what goes into it but 

22 also what goes onto it.
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1 Organic soap will never harm human skin 

2 or the environment in the same way that detergent 

3 based synthetic soap does. If the law is clarified 

4 so that potassium hydroxide is officially recognized 

5 as the processing agent that it is, organic soap 

6 makers will be able to advertise their product for 

7 what it is. An organic product made with organic 

8 ingredients made in much the same way that humanity 

9 has been making soap for over 4,000 years.

10 On behalf of organic soap manufacturers, 

11 we request that NOSB clarify the classification for 

12 potassium hydroxide as a processing aid, paving the 

13 way for truly organic certified soaps. Thank you for 

14 your time and consideration.

15 CHAIR FAVRE: Thank you very much. Any 

16 questions? Thank you. Next up is Jim Crawford 

17 followed by Mark Stanley on deck.

18 MR. CRAWFORD: Thank you very much for 

19 this opportunity to speak on some general topics. My 

20 name is Jim Crawford and for 44 years my wife and I 

21 have owned and made our family's living on New Morning 

22 Farm, a certified organic vegetable farm of 95 acres 
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1 in central Pennsylvania.

2 In addition to our many vegetable crops, 

3 we sell eggs from our flock of 400 pastured laying 

4 hens. Besides my farming work, I am a founder and 

5 President of a producer's marketing cooperative, 

6 Tuscarora Organic Growers Cooperative which since 

7 1988 has been owned by its members, approximately 50 

8 growers like myself all certified organic.

9 On our farm, we've been growing 

10 organically since the beginning in 1972. In 1987 we 

11 did become certified. And in 1990, we strongly 

12 supported the idea of USDA certification.

13 As the rules were made and the NOP and the 

14 NOSB were established, we were optimistic that the 

15 process would succeed in truly representing and 

16 legitimizing our growing methods. The legislation 

17 and the rules seemed to be well conceived to create 

18 an open democratic process that would have strong 

19 input from all sectors of the organic community.

20 We knew that there would always be threats 

21 to the organic, to the integrity of the word organic 

22 from powerful commercial interests that would seek to 
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1 weaken the standards to make it easier to profit from 

2 marketing organic foods. But we felt that the NOSB, 

3 being at the heart of this potential conflict, had the 

4 power and the duty to protect organic integrity.

5 We felt that the NOSB would be the key, 

6 the strongest guarantor of organic integrity. And 

7 that as long as the NOSB was constituted as intended 

8 by the law, as long as the NOSB maintained its power 

9 to define organic standards, that organic integrity 

10 would be safe.

11 Unfortunately, we are worried today. I 

12 feel a lot of respect and gratitude for the difficult 

13 work that you folks do. I'm personally unschooled in 

14 many of the arcane, complex issues that you have to 

15 deal with.

16 I do know, however, that way back in 1972, 

17 we organic farmers, unsophisticated as we were then, 

18 pretty much agreed on what the word organic meant. We 

19 agreed that synthetic inputs were not part of organic 

20 farming.

21 We agreed that soil, healthy, 

22 biologically active soil was the very essence and key 
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1 feature of organic farming. Soil, not plant 

2 nutrients formulated by humans and fed to plants 

3 indoors through plastic tubes.

4 And we agreed that organic animal 

5 agriculture should be based on pasture. That is, on 

6 grass, dirt, sunlight, and fresh air. We never 

7 imagined that organic milk, meat, or eggs could be 

8 produced on huge pads of concrete or vast, muddy feed 

9 lots in factory like conditions.

10 So we farmers are dismayed at the trends 

11 that we see in the ways the word organic is being 

12 abused today in agriculture. A great many of us 

13 organic farmers believe in the work and trust in the 

14 work and the views of the Cornucopia Institute.

15 Many of us have supported the Cornucopia 

16 people for many years. We think they have enormous 

17 integrity and expertise. We think that they 

18 understand the issues and the details.

19 So I respectfully encourage you, Members 

20 of the NOSB, to listen to the seasoned experts on 

21 Cornucopia staff who have the best interests of all 

22 of us at heart. And who only hope to protect the 
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1 integrity of organic agriculture. Thank you very 

2 much for letting me speak.

3 CHAIR FAVRE: Thank you very much. Any 

4 questions? Thank you for your comments. Next up is 

5 Mark Stanley with Roy Brubaker on deck.

6 MR. STANLEY: I want to thank you for 

7 having us here this evening. And thank Cornucopia 

8 for allowing us to be part of the representation of 

9 this brief time. My name is Mark Stanley and I am a 

10 farmer.

11 We have been farming in Three Springs, 

12 Pennsylvania since 1986, for 30 years. And before 

13 that, I actually started organic farming in 

14 California in 1972 and was part of a founding movement 

15 of the CCOF. In the mid '80s, I also was able to help 

16 organize and become involved with the OCIA, an organic 

17 certifying organization.

18 I realize you don't know me from Adam. But 

19 we do know each other in the fact that we have the 

20 propensity to act in self-serving and selfish ways. 

21 Or we can choose to act in openness and fairness, set 

22 our criteria based upon the foundations of the organic 
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1 movement.

2 These foundations, since I've been a 

3 farmer, since 1972, have been our operating model. 

4 The time honored and proven method of openness and 

5 honesty within the decision making of organic 

6 standards by yourselves, the Board, and with the other 

7 groups that I've been involved with.

8 The farmers have been the ones to lead 

9 forth in honesty and primarily a concern for the good 

10 of the community. Profit motive was really not our 

11 motivation. We were concerned with soil, health, 

12 life, et cetera.

13 We, ourselves as farmers, are held to a 

14 traceability, transparency in all our farming 

15 practices. And so again, we want to urge the Board 

16 that you also maintain these same standards. 

17 Foundations are important, going back to my 

18 beginnings, for openness, transparency, what is 

19 organic, and how the decisions are made.

20 I urge you to continue on these same 

21 foundations. Thank you very much.

22 CHAIR FAVRE: Thank you. Any questions? 
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1 Thank you very much. Next up is Roy Brubaker followed 

2 by Manojit Basu.

3 MR. BRUBAKER: Thank you. I'm a farmer 

4 in Juniata County, Pennsylvania, one of the smallest 

5 counties in the state. But it has 66 certified 

6 organic farms, second only to Lancaster County which 

7 is two and a half times larger and with 25 times more 

8 population. We have an organic farm for about every 

9 360 people.

10 We are in the Appalachian region of 

11 Pennsylvania between the mountains. We are one of 

12 the poorer counties I would say. But these farms are 

13 doing well and are dependent, very much, on the 

14 integrity provided in the organic seal in marketing 

15 their products because their local populations are 

16 quite small.

17 Our own farm, certified since 1991, 

18 markets to State College in Harrisburg. Our 

19 clientele are largely well educated professors, 

20 professionals. And they are very concerned that 

21 government is seen as a vehicle of integrity in 

22 guarding the organic meaning.
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1 I myself am a second generation organic 

2 farmer with a 70 year memory back to the time when my 

3 parents decided to farm organically after 15 years of 

4 struggle trying to restore a nutrient depleted and 

5 badly eroded 120 acre farm.

6 In my lifetime, I've seen that farm come 

7 alive and pass on to the second generation with my 

8 brother becoming the farmer. I returned to farming 

9 sometime later and developed the vegetable, fruit, 

10 and poultry farm which was just turned over to the 

11 third generation of organic farmers. And I now work, 

12 since January 1st, as a laborer for my daughter who 

13 is managing this organic farm.

14 It sustains three families. It provides 

15 opportunities for several apprentices to learn the 

16 organic methods. And we've been very blessed to see 

17 many of them go on to find their own livelihood in 

18 providing organic vegetables to their communities.

19 My dad, later in his life, developed value 

20 added products from his grains and to begin to mill 

21 and market various flours, meals, and so on from the 

22 grains that were grown on the farm. And his product 
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1 list, at the very top, he listed these words, the 

2 quality of a product is directly dependent on the 

3 integrity of its producer.

4 And he established integrity with his 

5 clientele by sharing freely all that he knew and was 

6 learning about his methods. And I think that needs 

7 to continue today. I support the work of Cornucopia 

8 and its advocacy for integrity.

9 CHAIR FAVRE: Thank you very much. Any 

10 questions? Thank you for coming. Next up is Manojit 

11 Basu followed by Colin Archipley.

12 DR. BASU: Thank you very much Madame 

13 Chair and the NOSB Board for this opportunity to talk 

14 on carrageenan. That's where I'll be presenting my 

15 comments. I'm Manojit Basu. I have a PhD in 

16 molecular biology with a focus on allergenicity and 

17 toxicity.

18 And I'm representing the Grocery 

19 Manufacturers Association here which is a trade 

20 organization representing the world's leading food, 

21 beverage, and consumer product companies.

22 What I want to start with is the history 
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1 of carrageenan. And someone in the morning started 

2 with Robert Frost, The Road Not Taken. And 

3 carrageenan is something which has been used for 

4 centuries.

5 So what I would want to say is that's a 

6 road which has been taken for centuries. And are we 

7 questioning whether it's safe or not? I, as a 

8 scientist, am not concerned about the safety of the 

9 product.

10 As you can see on the screen here from 

11 regulatory approvals, whether we talk about the U.S. 

12 FDA or whether carrageenan is recognized, generally 

13 recognized as safe. Or whether the FAO/WHO body, the 

14 JECFA saying carrageenan is safe and the recent 

15 approval in 2015. It all shows that carrageenan is 

16 a safe product and there isn't a concern on the safety 

17 of the product.

18 Now coming to the technological need, why 

19 do we need carrageenan in organic product? It 

20 definitely has a technological need. The function it 

21 provides as a stabilizer is what is needed mostly in 

22 infant formula as well as in several dairy as well as 
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1 processed meat food products.

2 And I did hear someone saying that, you 

3 know, bottle of milk can be finished by a baby in 15 

4 minutes. And I envy those because my kid doesn't want 

5 to drink it in 15 minutes.

6 So finally finishing, what I have seen is 

7 also some publications on the inflammation of the 

8 cells. And as a scientist and having researched on 

9 allergenicity, those could be allergenic reactions. 

10 And if there are sections of population who are 

11 allergenic to carrageenan, I totally understand that.

12 But my question, what I want to leave here 

13 with is, even peanuts are as known allergens. So what 

14 do we do? Do we ban peanuts from considered organic? 

15 Or we do we label them so that people who are allergic 

16 to peanuts avoid them? Thank you very much.

17 CHAIR FAVRE: Thank you. Any questions? 

18 Thank you for coming.

19 DR. BASU: Thank you.

20 CHAIR FAVRE: Next up is Colin Archipley 

21 followed by Karen Archipley.

22 MR. ARCHIPLEY: Good afternoon. I'm 
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1 here today as both a soil and a container grower. And 

2 we've been certified in both our production systems 

3 since 2007. And I first want to address a few of the 

4 concerns that were brought up this morning.

5 One of which was a comparison of 

6 containerized production systems and biology 

7 compared to soils. For one, that's a moving target 

8 being that there's different soil types of 

9 productions as well as containerized productions.

10 But I can tell you from my experience and 

11 observation in our own systems, because our 

12 containerized systems produce an ideal environment 

13 for these organisms to thrive, we have extracted 

14 samples from the root zone and observed a higher 

15 biological content activity than in many of our soil 

16 samples. I should say field grown samples.

17 And we have observed everything from 

18 bacteria to protozoa, nematodes, fungi, worms, and 

19 much more in those systems.

20 Another issue brought up this morning was 

21 the use of off farm inputs compared to typical field 

22 grown production. Because these systems are 
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1 containerized, that means none of the inputs are loss

2 which means overall input use is reduced, becoming 

3 more sustainable.

4 Studies have also shown greenhouses use 

5 less energy overall than field grown production. And 

6 because its energy is typically derived on electrical 

7 form, many of those, most of that energy can be offset 

8 to alternative energy systems. And compared to field 

9 growers who are reliant on fossil fuels to fuel their 

10 farm machinery.

11 I'd encourage the Board to use an analogy 

12 not to be the coal miner that fears the solar industry. 

13 But to actually adopt and accept innovation that 

14 harnesses the power of biological and organic inputs. 

15 These systems disrupt current markets and that's bad 

16 for the status quo. And I'd like to talk to you about 

17 that in just a minute.

18 Another thing that was brought up this 

19 morning was the idea of filtering out organic matter 

20 from these systems. That just doesn't make sense. 

21 If you filter out organic matter from these systems, 

22 you can't feed the biology. If you can't 
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1 feed the biology, that means that processes like 

2 nitrification can't occur which means your plants 

3 aren't going to get the nutrients in order to thrive 

4 which means you'll fail.

5 The National Organic Program falls under 

6 the Agricultural Marketing Service. That means you 

7 have to put the consumers first, not the farmer. It's 

8 a marketing brand. Therefore, if you do studies 

9 about -- and you've heard these studies already today, 

10 that the use of container production is not a concern 

11 from the market.

12 And I want you to take this into account, 

13 if you exclude container production, who are you going 

14 to disenfranchise? You're going to disenfranchise 

15 the poor who can't afford rural agricultural land.

16 Furthermore, history shows that ag land 

17 only consolidates over time which means there are 

18 going to be fewer and fewer farmers if you don't allow 

19 these processes in the organic space.

20 Others who will be disenfranchised are 

21 beginning farmers, rural farmers, those who lack 

22 access to financial resources through no fault of 
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1 their own to purchase rural land as well as already 

2 disadvantaged farmers as well as consumers and the 

3 environment.

4 We have dozens of container growers in the 

5 organic industry today only because these production 

6 systems allowed increasing yield with decreased space 

7 and land overall.

8 And ultimately, studies have shown these 

9 systems overall are more sustainable. And 

10 sustainability is not a belief system. It is 

11 measurable. We can measure the reduction in water. 

12 We can measure the reduction in overall inputs. 

13 Thank you.

14 CHAIR FAVRE: Any questions? Thank you 

15 very much. Next up is Karen Archipley followed by 

16 Nate Lewis who will be our last commenter for the day.

17 MS. ARCHIPLEY: Hi. My name is Karen 

18 Archipley and I'm co-founder of Archi's Acres and 

19 Archi's Institute for Sustainable Agriculture. We 

20 train beginning farmers, many just transitioning from 

21 the military. But also civilians who wish to choose 

22 agribusiness as a career.
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1 Many of our students have gone on to start 

2 their own farms. And most, if not all, have chosen 

3 containerized production due to the affordability of 

4 rural land which is unattainable due to the financial 

5 resources. And most, if not all, are farming without 

6 the use of -- I'm sorry. Most would not be 

7 farming at all without the use of containerized 

8 production systems due to the productivity in limited 

9 spaces and limited inputs.

10 Science can show -- also many are in urban 

11 areas. Science can show biological processes 

12 conducted in containers are equivalent to field 

13 production. There's been a lot of misinformation 

14 about the use of synthetic and inert inputs.

15 Any grower, either in containers or the 

16 field using these inputs described in the 

17 misinformation, should be denied certification. And 

18 that process is already in place by our certifiers. 

19 Correct?

20 Archi's Acres has never used synthetic 

21 inputs, either approved or not, in the use of ozone, 

22 chlorine, chemicals, or that that the opponents have 
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1 attempted to associate with our containerized 

2 production systems.

3 It's our hope that you will see through 

4 this misinformation. And instead, take some time to 

5 read the research and understand the facts. We are 

6 in 2016. We should not be afraid of innovation. In 

7 fact, our planet is insisting on it.

8 The container method was not raised as a 

9 concern in a recent OTA research consumer study or in 

10 the CCOF Blueprint for an Organic World which took 18 

11 months. I'm on the Executive Committee there. And 

12 I will tell you that that is true. This is a concern 

13 from growers, not consumers.

14 So let's embrace this new generation of 

15 organic growers. Let's be inclusive not exclusive. 

16 Happy to take any questions.

17 CHAIR FAVRE: Thank you. Any questions? 

18 Thank you very much.

19 MS. ARCHIPLEY: Thanks so much.

20 CHAIR FAVRE: Our final commenter today 

21 will be Nate Lewis.

22 MR. LEWIS: Well I know I'm the only thing 
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1 standing between you all and the ACA meeting so I'll 

2 keep it brief. In 2010, NOSB passed the 

3 recommendation, 12 yes, 1 no, 2 absent, providing 

4 guidelines on how greenhouse and containerized 

5 production systems should operate to ensure 

6 compatibility with organic production principles.

7 This was the last opportunity for public 

8 comment on the issue of hydroponics and containerized 

9 production. And the Organic Trade Association 

10 supported that recommendation.

11 This recommendation included a specific 

12 definition for hydroponics, aeroponics, and 

13 containerized and greenhouse production. The NOSB 

14 recommended a prohibition on hydroponics and 

15 aeroponics as defined by the recommendation in 

16 organic production.

17 The recommendation included detailed 

18 guidance concerning organic greenhouse and container 

19 grown plant production. Lastly, the NOSB 

20 recommendation remained silent on the question of 

21 aquaponics specifically. But did recommend that 

22 growing media shall contain sufficient organic matter 
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1 capable of supporting natural and diverse soil 

2 ecology.

3 OTA supports the work of the Hydroponic 

4 Task Force as it brings further clarification and 

5 definition to this range of production practices. We 

6 look forward to continued discussions on the topics 

7 of hydroponics and containerized production systems 

8 and will engage in any public process that occurs as 

9 a result of the NOSB task force on the issue.

10 The Board represents diverse farming 

11 systems and regions. As farming struggles with 

12 massive global challenges like climate change and 

13 water scarcity, we need to remember to look 

14 regionally, environmentally, look at regionally and 

15 environmentally adaptive systems. And strive for 

16 those systems to be consistent with organic 

17 principles. The grass ain't greener, the wine ain't 

18 sweeter either side of the hill.

19 Secondly, this Livestock Subcommittee is 

20 proposing some changes to annotations and use 

21 patterns related to synthetic parasiticides in 

22 organic livestock production. As we explained in our 
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1 comments, OTA supports the work of the subcommittee 

2 and particularly pleased to see the expansion of use 

3 to sheep for wool.

4 We're encouraged by hearing earlier you 

5 did consider off label use when deliberating on your 

6 recommendation. And we appreciate that you'll be 

7 bringing forward additional Board work on better 

8 defining emergency use of parasiticides as it is the 

9 most effective way to ensure these products are used 

10 in the most judicious manner possible.

11 You've all read our comments and perused 

12 our NOSB booklet. And I welcome any questions or 

13 clarifications you may have for OTA on our comments 

14 and positions. Thank you.

15 CHAIR FAVRE: Thanks Nate. Any 

16 questions?

17 MR. LEWIS: MPEs? Come on. No? All 

18 right. Thanks everybody.

19 CHAIR FAVRE: Thank you. Okay. 

20 Everybody, we are adjourned for the day. And we will 

21 be starting back here tomorrow at 8:30. Thank you 

22 very much and you all have a nice evening.
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1 (Whereupon, the above-entitled matter 

2 went off the record at 6:18 p.m.)

3

4
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UNITED STATES DEPARTMENT OF AGRICULTURE

+ + + + +

NATIONAL ORGANIC STANDARDS BOARD

+ + + + +

SPRING 2016 MEETING

+ + + + +

TUESDAY

APRIL 26, 2016

+ + + + +

The Board met in the Blue Room of the 

Omni Shoreham Hotel, 2500 Calvert Street, N.W., 

Washington, D.C., at 8:30 a.m., Tracy Favre, Chair, 

presiding.
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PRESENT

TRACY FAVRE, Chair

TOM CHAPMAN, Vice Chair

HAROLD AUSTIN

CARMELA BECK

HARRIET BEHAR

A-DAE ROMERO-BRIONES

JESSE BUIE

LISA DE LIMA, Secretary

EMILY OAKLEY

SCOTT RICE

JEAN RICHARDSON

DAN SEITZ

ZEA SONNABEND

ASHLEY SWAFFAR

FRANCIS THICKE

ALSO PRESENT

STAFF:

MICHELLE ARSENAULT, Advisory Board Specialist, 

National Organic Program

LISA BRINES, National List Manager, National 

Organic Program

EMILY BROWN ROSEN, Agricultural Marketing 

Specialist, National Organic Program

PAUL LEWIS, Director, Standards Division, 

National Organic Program, USDA 

MILES McEVOY, Designated Federal Officer, Deputy 

Administrator, National Organic Program

PANELISTS-EMERGING TECHNIQUES IN AGRICULTURAL 

BIOTECHNOLOGY:

DAVID GOULD, International Federation of Organic

Agricultural Movements (IFOAM)

MICHAEL HANSEN, Consumers Union

RALPH SCORZA, Agricultural Research Service, USDA

WILLIAM TRACY, University of Wisconsin-Madison
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C-O-N-T-E-N-T-S

Call to Order ................................. 6

Public Comments

Kent Henderson ............................... 6

Donald Bliss ................................. 15

Eugene Ung, Best Formulations ................ 30

John Ashby ................................... 37

Peter Barbera, Shoreside Organics ............ 42

Garth Kahl ................................... 54

Scott Rangus, Ingredient Solutions ........... 60

Nicholas Gardner, On Behalf of Marinalg

International........................... 72

Anicia Hurtado, On Behalf of Marinalg

International ......................... 83

Dr. Urvashi Rangan, Food Safety and

Sustainability Center

Consumer Reports........................ 91

Dr. James "Jim" McKim ........................ 97

Linda Froelich, FMC ......................... 105

Marty Mesh, Florida Organic Growers ......... 109

Jane Parker, Botanical Food Company,

Australia.............................. 116

Suzanne McMillan, ASPCA

Reading of an Inspirational Passage ......... 120

"Putting in the Seed" By Robert Frost

Scott Rice, Member..................... 124

Annie Rouse ................................. 125

Lydia Henshaw, Sow Organic .................. 132

Jaydee Hanson, Center for Food Safety ....... 135

Jennifer Lonergan, The Humane Society of the

United States.......................... 140

Britt Lundgren, Stonyfield .................. 144

Bob McGee, Straus Family Creamery

Also Representing Eight

Organic Dairy Farming Families......... 149

Albert Straus ............................... 153

Marni Karlin, Organic Trade Association ..... 158

Rhodes Yepsen, Biodegradable Products

Institute.............................. 162

Drew Norman, One Straw Farm ................. 163

Joan Norman, One Straw Farm ................. 164
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Public Comments (cont.)

Peggy Miars, Organic Materials

Review Institute....................... 169

Jackie Sleeper, Oregon Tilth Certified

Organic................................ 173

Mabell Rivas, QAI ........................... 178

David Hiltz, Acadian Seaplants, Canada ...... 181

Ross White, FMC ............................. 185

Beth Unger, CROPP Cooperative ............... 191

Stephen Walker, MOSA ........................ 196

Lyn Coody, Organic Produce Wholesalers 

Coalition.............................. 202

Kate Houston, Cargill ....................... 208

Clara Poffenberger, New Family Farm ......... 213

Johanna Mirenda, OMRI ....................... 217

Agus Sastra, On Behalf of Over 25,000

Seawood Farmers in Indonesia........... 222

Erick Ask, FMC .............................. 224

Bill Blakemore, Celtic Colloids ............. 231

Jackie DeMinter, MOSA ....................... 236

Nina Mahmoudpour ............................ 241

Alexis Randolph, Quality Assurance

International.......................... 245

Lauren Berlekamp, Hemp Industries

Association............................ 249

David Will .................................. 253

Bill Wolf ................................... 257

Laura Batcha, Organic Trade Association ..... 260

Richard Siegel, On Behalf of Absorbent

Products Limited, B.C.................. 268
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Expert Panel Discussion on Emerging

Technologies in Agricultural Biotechnology

Dr. David Gould........................ 275

Program Facilitator for IFOAM

Organics International

Dr. Ralph Scorza....................... 284

Research Horticulturist and Lead Scientist

Genetic Improvement of Fruit Crops

Research Unit, USDA-ARS

Dr. Michael Hansen..................... 297

Senior Staff Scientist, Consumers Union

(Publisher of Consumer Reports)

Dr. William "Bill" Tracy............... 310

Clif Bar Family Foundation and Organic

Valley, Professor of Organic Plant

Breeding and Chair of the Department of

Agronomy, UW-Madison

 Questions and Comments .................... 320

Materials Subcommittee

Excluded Methods Terminology ............................ 361

and Two Discussion Documents

Seed Purity - Discussion Document ........... 379

Livestock Subcommittee

Hypochlorous Acid Petition Proposal ......... 389

Lidocaine and Procaine ...................... 407

Parasiticides Proposal ...................... 417

Policy Development Subcommittee

Policy and Procedures Manual ................ 448

2017 Sunset Timeline Reorganization ......... 508

Adjourn
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1 P-R-O-C-E-E-D-I-N-G-S

2 8:31 a.m.

3 CHAIR FAVRE: (presiding) Good 

4 morning. Thank you for joining us for the second 

5 day of our meeting today.

6 We are going to continue with public 

7 comments this morning. Okay. Our first speaker 

8 will be Kent Henderson, followed by Donald Bliss 

9 on deck.

10 (Pause.)

11 DR. HENDERSON: Good morning.

12 CHAIR FAVRE: We are waiting for the 

13 timer. So, just bear with us for a moment.

14 (Pause.)

15 DR. HENDERSON: Good morning again.

16 The purpose of my comment today is to 

17 encourage the NOSB to approve a two-day 

18 milk-withholding period for dairy cattle treated 

19 with fenbendazole, as recommended by the Livestock 

20 Subcommittee.

21 And also, the second purpose is to ask 

22 for the elimination of continued use of ivermectin.
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1 My name is Kent Henderson. I'm a 

2 long-time dairy-exclusive veterinarian. I have 

3 treated many parasitized herds with very good 

4 results using whole-herd fenbendazole treatments.

5 Fenbendazole peak level at 24 hours is 

6 actually 10 times less than the FDA safety level. 

7 So, a two-day milk-withholding time on a product 

8 that has zero-day withhold product from the FDA can 

9 assure the organic consuming public that the milk 

10 is a safe product from healthy cattle.

11 Fenbendazole is a superior product to 

12 use on organic cattle because it is not absorbed 

13 by mammalian tissue. It accumulates in the 

14 parasite and not in the cow.

15 If you look at this chart, at the graph, 

16 you will see the red curve is fenbendazole. You 

17 will see how rapidly it is absorbed, and it is out 

18 of the animal totally in 72 hours. Whereas, in 

19 comparison, ivermectin, it takes seven to eight 

20 days to reach peak killing level and, then, 

21 continues to be excreted for 60 days. This is 

22 leading to resistance problems in using these 
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1 products and, also, a more complete kill of dung 

2 beetles on pasture with the 60-day exposure.

3 On this graph you will see how effective 

4 fenbendazole has been after over 25 years' use. 

5 The column on the right indicates that, overall, 

6 it has got still over 98-percent success rate.

7 And then, in the same study, if you 

8 compare Ivomec- and ivermectin-type products, you 

9 will see how fast the percent of efficacies drop 

10 down to 58 percent.

11 This is a pasture where buffalo run that 

12 have been treated with Ivomec, with Eprinex, and 

13 you will see all the fecal pats that have not been 

14 broken down by dung beetle. Dung beetle is very 

15 important in bringing nutrients into the soil, 

16 improving soil health. This is a strong reason to 

17 discontinue the use of ivermectin.

18 After finding 35 of her 65 cattle 

19 coughing and sick, this producer called our 

20 practice after she had used an approved product 

21 that had been advised by her certifier. We took 

22 samples. Cornell Lab diagnosed it as lungworm, 
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1 and I prescribed the use of Safe-Guard pellets to 

2 these cattle. They recovered, but there was a huge 

3 financial loss to the farm, not from dead cattle 

4 and loss of production, but from having to operate 

5 on non-organic prices, and the herd loss, $55,000 

6 in milk sales in a three-month period because of 

7 the milk withhold.

8 And I guess I am ready for questions.

9 CHAIR FAVRE: Any questions?

10 Francis? Then, Harriet.

11 MEMBER THICKE: Thank you for that 

12 presentation.

13 Can you tell us a little bit about, 

14 since you are veterinarian, about off-label use of 

15 things like garcidicides because some of the 

16 garcidicides aren't labeled I think for goat and 

17 sheep? Can you explain how that works?

18 DR. HENDERSON: My practice is limited 

19 to dairy cattle. The following speaker is very 

20 well prepared to speak to that. But I can tell you 

21 with dairy cattle the off-label use would be in this 

22 lungworm-infested herd. I always prescribe 
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1 coming back again six weeks later and doing a repeat 

2 treatment. And I do that also with my strategic 

3 deworming.

4 The reason I think it is important to 

5 have a veterinarian involved in these strategic 

6 deworming processes is because we offer the 

7 diagnoses. We are at the herd every month. We are 

8 monitoring what is going on, and we are the stimulus 

9 to the dairy producer to stay on the product and 

10 the practice until his pastures are actually 

11 cleaned up, you know, very significantly on eggs, 

12 parasite eggs.

13 CHAIR FAVRE: Harriet?

14 MEMBER BEHAR: Our rule does have for 

15 emergency use only. So, we are hoping that it is 

16 not going to be used pervasively. But I am a little 

17 concerned about, especially for sheep and goats, 

18 that maybe only having one parasiticide, if we 

19 remove the ivermectin, not that I like ivermectin, 

20 but I am wondering about resistance to fenbendazole 

21 and moxidectin. I know we have seen that with 

22 ivermectin because so much of its pervasive use. 
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1 I am wondering if there is any of that happening 

2 with those other two parasiticides.

3 DR. HENDERSON: All right. Well, as I 

4 showed in my tables up there with FBZ, 

5 fenbendazole, it has been in use for over 25 years. 

6 That study demonstrated very clearly that 

7 fenbendazole is continuing to have over 98-percent 

8 effectiveness. That is in, I think it is a 

9 400-herd study. So, that is a really powerful 

10 study to defend that FBZ is maintaining and the 

11 others are dropping, the others, as you could see 

12 in the table.

13 This is all in my written comments, by 

14 the way. There is a lot more in my written comments 

15 than what I am able to say today. But it is very 

16 clearly written out there, and it shows how the 

17 efficacy is dropping.

18 As far as if I had to choose, I am not 

19 really prepared to say too much about Cydectin. I 

20 don't use it much in my practice. But I know that 

21 it is in the same class as the Ivomec. I think it 

22 is more effective. I think if you keep those two 
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1 in the mix and get rid of Ivomec, I think you are 

2 going to have two really good dewormers on hand for 

3 emergency situations.

4 But I would caution you not to ignore 

5 the strategic deworming and the preventive effects 

6 that the veterinary practice can provide to the 

7 organic producer. We would really like to get 

8 ahead and stimulate the immune system of these 

9 animals at the peak when they really need it. The 

10 cow really needs her peak performance on her immune 

11 system the day she freshes.

12 And if I put fenbendazole in front of 

13 her, I know that I see improved production, 

14 improved fertility. But, if the producer is 

15 expected to live on non-organic price for the first 

16 90 days of her lactation, it takes all advantages 

17 away and it puts the animal at risk of secondary 

18 invaders, other bacteria and other viruses 

19 affecting the animals. So, I really would like to 

20 have that in the organic producers' toolbox.

21 CHAIR FAVRE: Jean?

22 MEMBER RICHARDSON: So, Dr. Henderson, 
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1 you have a lot of this in your written comments, 

2 as I recall, which we have all looked at. So, you 

3 see this as being an animal welfare issue, in 

4 addition to just the cost involved in the milk loss 

5 for the 90-day withholding?

6 DR. HENDERSON: Yes. I think the next 

7 speaker will indicate to you the effect it has on 

8 the animals. I think that organic production has 

9 a great reputation as far as promoting animal 

10 welfare and is trying to set itself apart in that 

11 regard.

12 In our parasite evaluation clinics, 

13 every organic farm that we have tested, we find 

14 significant worm loads. We have got 22 organic 

15 farms. We have tested 15 of them, and in every one 

16 of them we find parasite eggs, and this strategic 

17 deworming would work.

18 I think that it is definitely these 

19 animals are being asked to work at a real detriment 

20 to their immune system, and it leaves them open to 

21 infection and they are living with an anemia. They 

22 are not living in a thrifty state. And I really 
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1 don't think that that is an image that organic wants 

2 out there.

3 CHAIR FAVRE: Francis?

4 MEMBER THICKE: What about

5 alternatives, natural alternatives? I know there 

6 is a company in Pennsylvania, a company in 

7 Wisconsin that have some things. I have used them 

8 in young stock, very young stock, and found good 

9 results.

10 DR. HENDERSON: Okay.

11 MEMBER THICKE: But do you recommend 

12 some of those?

13 DR. HENDERSON: I haven't seen the type 

14 of research on products like that to really give 

15 me confidence to go in and use them. I can tell 

16 you that the photo I showed of the Jersey dairy cow 

17 that had the lungworm, she had had aloe vera 

18 pellets. She had had diatomaceous earth. And 

19 then, there was one other product she had had. And 

20 the producer tried for 10 days to use those 

21 products, and we had to resort to that.

22 I have used a few approved products for 
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1 external parasite control which I had really, 

2 really good results with, with some louse 

3 infestations. But, as far as internal parasites 

4 are concerned, this is the product that I have had 

5 the best results with.

6 I'm not denying that it can't happen, 

7 but I would just like to see more research before 

8 I would go very far with it.

9 CHAIR FAVRE: Any other questions?

10 (No response.)

11 Thank you very much.

12 DR. HENDERSON: All right. Thank you.

13 CHAIR FAVRE: Next up is Donald Bliss, 

14 with Eugene Ung on deck.

15 DR. BLISS: Yes. Thank you. It is a 

16 pleasure to speak today.

17 I, too, support the fenbendazole, 

18 moxidectin in organic milk with a two-day 

19 withdrawal and, also, see that ivermectin kills the 

20 dung beetle and has a high level of blood levels 

21 that last for about 35-40 days.

22 I am a veterinary parasitologist out of 
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1 Wisconsin. We have got a parasite lab there. We 

2 do thousands of samples every month from all over 

3 the country of all nature.

4 We have these people who can go into our 

5 website: how to collect samples, how to send 

6 samples. We also go out around the country. I 

7 spent every week for the last six-seven weeks, we 

8 just travel from all over the country and set up 

9 these parasite clinics and monitor parasite 

10 problems that we can see across the country. So, 

11 we have a good feeling in all 50 states.

12 We use a Modified Wisconsin Sugar 

13 Flotation, and that was designed for lactating 

14 dairy cows. It is really the only technique that 

15 gives you a great value on it.

16 We look at parasite control as kind of 

17 the keystone to everything else we are doing with 

18 these animals. If these animals are 

19 parasite-free, they convert better; their vaccines 

20 work better; they have got better feed conversion, 

21 better hair coat, and so forth.

22 We also look at that immune system. 
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1 This is a review of publications from Iowa State, 

2 170 publications. They looked at five different 

3 technologies, ionophores, implants, growth 

4 promotants. And deworming returned the greatest 

5 value to the producer of all the technologies.

6 We look at what these parasites do. 

7 They live off the cattle. They shed eggs back in 

8 the environment. This process has been going on 

9 for thousands of years.

10 What we try to do with strategic-timed 

11 deworming is prevent the shedding of eggs back on 

12 that pasture. If that pasture has become 

13 infected, there is nothing you can do with it. You 

14 have to prevent it. So, we believe in preventative 

15 treatment.

16 To show what these parasites do to the 

17 animals themselves, you can see that the pastures 

18 that were dewormed, you see those cattle are up 

19 there grazing. They feel well. These are all 

20 blind studies, but we can drive out and we can see 

21 the cattle laying down. We know which cattle are 

22 the wormy cattle because they don't feel well; they 
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1 are not up grazing.

2 In this particular study there was 60 

3 pounds difference between the 

4 strategically-dewormed cattle and the worming 

5 cattle. It comes from here. These parasites go 

6 into this gastric gland. They form a mucous plug. 

7 They go through a double MALT. They crush the 

8 cell.

9 That cell is produced in HCl. So, what 

10 happens to that pH in that gut is that the pH goes 

11 up. As the pH goes up, fiber digestion drops. As 

12 fiber digestion drops, the animal is full, so that 

13 material is not moving down the GI tract.

14 This is also a very vascular area. So, 

15 the immune system is fighting off these parasites. 

16 It is sending down mast cells, what we call Th2 

17 cells, to fight off these parasites. By doing 

18 that, it --

19 (Timer rings.)

20 Am I done?

21 (Laughter.)

22 CHAIR FAVRE: That is the time, but why 
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1 don't you finish that sentence?

2 DR. BLISS: Okay. It suppresses the 

3 immune system and is directly related to the worm 

4 burden. The higher the worm burden, the more we 

5 see a problem.

6 So, for example, we seldom see 

7 coccidiosis. Pinkeye, if we have got pinkeye 

8 problems, we oftentimes will put fenbendazole in 

9 the mineral and treat these cattle on pasture, and 

10 the disease will go away, because the immune system 

11 can fight it off by itself.

12 CHAIR FAVRE: Great.

13 DR. BLISS: Sorry.

14 CHAIR FAVRE: Emily?

15 MEMBER OAKLEY: Thank you.

16 So, are you suggesting that it needs to 

17 be used more preventatively than just on an 

18 emergency basis? And how would you define an 

19 emergency basis?

20 DR. BLISS: Well, I think from an 

21 animal welfare standpoint we want preventative 

22 basis because I think, as you saw in that picture, 
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1 these animals don't feel well. And you don't want 

2 to wait until the animal is full of worms, then you 

3 try to treat them. That is why some of our 

4 dewormings don't work. If you use them at a night 

5 where you prevent the parasite, then you have less 

6 problems and you respond.

7 We can show you some feedlot trials, and 

8 so forth, where animals that were strategically 

9 dewormed did much better than those that they 

10 brought them in wormy, then treated them in the 

11 feedyard. The ones that were treated on pasture 

12 went through with much less disease problems, less 

13 health problems.

14 CHAIR FAVRE: Jean?

15 MEMBER RICHARDSON: Dr. Bliss, as you 

16 know, in organic farming we can only use the 

17 parasiticides in an emergency situation. So, we 

18 can't, of course, go ahead and do any kind of the 

19 strategic deworming that can take place on a 

20 conventional farm.

21 So, in the work that you have done on 

22 organic farms --
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1 DR. BLISS: Yes.

2 MEMBER RICHARDSON: -- what have you 

3 seen to be the most useful ways to reduce parasite 

4 levels in the management practices of the dairy 

5 farmers, for instance?

6 DR. BLISS: Well, what we are doing is 

7 we base it on fecals. When the fecals come in, 

8 those are the ones that are telling us that, first 

9 of all, where there is smoke, there is fire; where 

10 there are worm eggs, we have got worms in the 

11 cattle.

12 And then, we can go in and break that. 

13 But it becomes a herd disease. So, once you 

14 identify you have got a heavy worm burden, we can 

15 go through and clean up the entire herd. That is 

16 what this milk withdrawal will allow us to do, if 

17 we can.

18 CHAIR FAVRE: Harriet?

19 MEMBER BEHAR: So, I am just wondering, 

20 when we are wrestling with defining what emergency 

21 use is, would we tie it to fecal samples and would 

22 lungworms show up in a fecal sample?
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1 DR. BLISS: Well, with a lungworm, we 

2 have to run a special test called Baermann test. 

3 But, usually, you will seldom ever see a lungworm 

4 problem without a GI parasite worm problem. So, 

5 your fecal will pretty well tell you whether or not 

6 you have got other issues. Because both Cydectin 

7 and fenbendazole control lungworm, the fecal test 

8 will give you that. You may not even have to take 

9 the next step for doing a Baermann for the lungworm.

10 MEMBER BEHAR: Are there threshold 

11 levels on fecal samples like by weight of animal 

12 or that sort of thing, where you decide this is a 

13 critical time to deworm the animal?

14 DR. BLISS: It is a complicated answer, 

15 but it is based on the time of the year. For 

16 example, if you are going into the winter with a 

17 high worm burden, you're not going to get any new 

18 parasites in there. So, a deworming then will 

19 leave that animal, render that animal worm-free 

20 until we have spring grass. So, there are some 

21 timings that you can do that actually help promote 

22 better health of the animals, and we do it through 
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1 a fecal, yes.

2 CHAIR FAVRE: Francis?

3 MEMBER THICKE: What about young 

4 cattle versus adults? Often, people say adults 

5 are more resistant. And one veterinarian once who 

6 wasn't real big on worming told me, he said, "You 

7 know, we are trying to build resistance into our 

8 herd. We don't want to be worming them all the time 

9 because we are not going to get that built up."

10 DR. BLISS: Yes, and you do want to have 

11 some exposure to the parasite. And so, one of the 

12 things, even with our strategic time deworming, we 

13 are allowing that. We are preventing a high 

14 buildup, but we are leaving a refugia on the pasture 

15 that will allow those animals to stimulate their 

16 immune system. So, we are really preventing it, 

17 but we are not eliminating the parasites.

18 And even in other species, you know, 

19 like sheep and goats, we come in with a fenbendazole 

20 and follow up by a Cydectin. Those two products 

21 are the best of their class of compounds, and that 

22 will prevent those parasites from overwhelming 
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1 them and clean them up.

2 CHAIR FAVRE: Dan?

3 MEMBER SEITZ: I imagine that 

4 management practices vary among organic dairy 

5 producers. Are there any particular management 

6 practices you have observed that are helpful for 

7 preventive care in this area?

8 DR. BLISS: Sure. From a parasite 

9 standpoint, one of the things we can do is alternate 

10 our pastures or moving cattle onto like, for 

11 example, take a cot of hay and move cattle onto that 

12 pasture. That is a worm-free pasture. So, we can 

13 time our dewormer around when we use our pasture 

14 based on seasonal. I mean, it is a little bit 

15 complicated, but as long as no cattle have been on 

16 that pasture for the first three months of the 

17 grazing, that is a parasite-free area. So, we can 

18 move. There are a few things we can do like that 

19 to help get them out of the face of the parasite 

20 challenge.

21 CHAIR FAVRE: Jean?

22 MEMBER RICHARDSON: Dr. Bliss, again, 
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1 back to this issue that Harriet brought up on 

2 emergency use because, obviously, there is a lot 

3 of concern that, if -- and, hopefully, when -- we 

4 pass these recommendations, that there may be an 

5 unnecessary increase in the use of parasiticides, 

6 just because they are not going to have the long 

7 milk withholding on their income.

8 But we want to be sure that the animals 

9 have high levels of animal welfare. What we are 

10 going to be doing after this meeting is trying to 

11 look at a definition of what constitutes an 

12 emergency situation. And so, should we, for 

13 example, be requiring that all the organic farmers, 

14 as part of their organic system plan, should have 

15 fecal cell counts, I mean fecal parasite counts as 

16 part of their management plan, that they show not 

17 only the pasture management that Dr. Seitz was 

18 mentioning, but also fecal counts, other aspects 

19 like that, that would allow us to say, yes, for 

20 sure, this is an animal welfare situation we need 

21 to move to using the parasite control?

22 DR. BLISS: Absolutely. Every herd is 
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1 going to be different, and every herd you can 

2 profile with the fecals. The fecal count really 

3 is not measuring how many parasites are in that 

4 animal as a rule, depending on what we are seeing. 

5 But what it does do is predict, it is a predictive 

6 value of what is going out on that pasture.

7 So, we can quickly say, if cow was 

8 putting out 10 eggs, that is 1500 eggs in a pound 

9 of manure. She is putting out 40 pounds of manure. 

10 That's 60,000 a day is going on that pasture. If 

11 she is putting out 80 pounds, you can calculate 

12 that. So, it is a predictive value of where that 

13 herd is going to be, yes.

14 CHAIR FAVRE: Francis, did you still 

15 have a question?

16 MEMBER THICKE: Yes. Back to that 

17 question of off-label use --

18 DR. BLISS: Yes.

19 MEMBER THICKE: -- for fenbendazole 

20 and moxidectin.

21 DR. BLISS: Yes.

22 MEMBER THICKE: They are not all 
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1 approved for goat, sheep, and cattle, are they?

2 DR. BLISS: No.

3 MEMBER THICKE: And how does that work?

4 DR. BLISS: Well, we had an operation 

5 in Kansas that they lost 3,000 head of sheep due 

6 to Haemonchus, the barber pole worm. What we did 

7 is we contacted their local vet. We got him to 

8 script Safe-Guard in there, fenbendazole in there. 

9 Sorry. And we had it run for a three-day. We came 

10 back on moxidectin on the fourth day. He scripted 

11 it, allowed it. So, it was very easy to solve.

12 We had the fecals to show and the death 

13 rates to show that we had a severe problem. We were 

14 able to stop that disease loss.

15 MEMBER THICKE: What about withdrawal 

16 time? I mean, because there's no established 

17 withdrawal time if it is not approved. And why is 

18 it not approved for some animals? Is it because 

19 they haven't submitted the requests through FDA or 

20 because --

21 DR. BLISS: Well, the fenbendazole, 

22 actually, it is the most widespread use. It is 
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1 cleared in poultry, swine, zoo animals. It 

2 doesn't have a sheep label because of the barber 

3 pole worm. When that barber pole worm goes to a 

4 high level, it goes inhibited, into an arrested 

5 development. Safe-Guard destroys the parasite's 

6 ability to metabolize energy. When it is 

7 inhibited, it is not metabolizing. So, what we use 

8 it is we treat them with fenbendazole to activate 

9 it out of the tissues, and we use the moxidectin 

10 to kill it.

11 But that is the reason it has not been 

12 in sheep. It is approved in goats and in cattle, 

13 you know, a wide range, but they didn't pursue 

14 because of the big Haemonchus problem.

15 CHAIR FAVRE: Jean?

16 MEMBER RICHARDSON: On the question of 

17 fiber, Dr. Bliss, one of the things that we are 

18 recommending is that it would be okay to use 

19 fenbendazole, for example, in sheep in such a 

20 manner that the wool could be still sold organic.

21 DR. BLISS: Yes.

22 MEMBER RICHARDSON: As I understand it 
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1 from the science and from your presentation today, 

2 because the fenbendazole goes to the parasite, it 

3 is not going to end up in the wool of the sheep.

4 DR. BLISS: That's correct.

5 MEMBER RICHARDSON: Is that correct?

6 DR. BLISS: Yes. Yes.

7 MEMBER RICHARDSON: Okay.

8 DR. BLISS: It is a very large 

9 molecule. It has an affinity for the parasites. 

10 The parasites can absorb it, ingest it; they can't 

11 excrete it. When they have enough, it destroys 

12 them. It has no effect on the tissues until we just 

13 found out two years ago it does it affect tumors. 

14 So, anything that is rapidly developing, it will 

15 shut it down. But, basically, that product will 

16 not be absorbed into the wool.

17 CHAIR FAVRE: Any other questions?

18 (No response.)

19 Thank you, Dr. Bliss.

20 DR. BLISS: Thank you.

21 CHAIR FAVRE: Next up Eugene Ung, 

22 followed by John Ashby on deck.
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1 MR. UNG: Hi. Good morning.

2 I'm here to give some comments about 

3 carrageenan. My name is Eugene Ung. I'm the CEO 

4 of Best Formulations. We are a contract 

5 manufacturer of dietary supplements located in 

6 southern California. We are an FDA-licensed, 

7 GMP-approved drug-licensed manufacturer of 

8 softgels, tablets, capsules, powders, and teabags.

9 Now carrageenan has been commonly used 

10 for decades in our industry as a thickening and 

11 stabilizer in powder formulations. More 

12 recently, we have been using carrageenan as a 

13 gelatin alternative in the manufacture of softgels 

14 and capsules in our industry.

15 Softgels are a very popular dosage form 

16 for encapsulating nutritional oils. Prior to 

17 2006, nearly all softgel capsules sold were made 

18 from animal gelatin sources, such as bovine, 

19 porcine, or fish. Non-animal, vegetarian softgel 

20 alternatives had been developed, but none were 

21 suitable for large-scale, mass application. So, 

22 along with FMC, we pioneered the development of the 
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1 first commercially-viable, non-animal softgel 

2 capsule in the dietary supplement industry.

3 The vegetarian softgel has been 

4 somewhat of a Holy Grail of softgel manufacturing 

5 for years. The carrageenan provides structural 

6 integrity for the soft capsule shell. Other 

7 biopolymers have been tried, but did not have the 

8 properties required to make a good softgel capsule.

9 Over the years, other companies have 

10 attempted to manufacture vegetarian softgels using 

11 other biopolymers such as potato starch, 

12 alginates, et cetera, without success. At this 

13 point, carrageenan is really the only natural 

14 biopolymer that has similar characteristics to 

15 animal gelatin.

16 Over the past several years, we have 

17 built a non-animal, vegetarian softgel market to 

18 meet the demands of vegetarians and other 

19 conscientious consumers looking for organic, 

20 healthy ingredients, offering them a non-animal 

21 alternative to traditional softgel capsules.

22 If carrageenan can no longer be used in 
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1 organic food or food in general, we could see the 

2 entire vegetarian, non-animal softgel market 

3 disappear, as there is no other 

4 commercially-viable, non-animal alternative to 

5 animal-based gelatins.

6 Safety is of utmost importance in our 

7 industry, and all materials used in our 

8 manufacturing business must be safe for human 

9 consumption. Carrageenan has been used as a 

10 natural ingredient in the food industry for decades 

11 and has been deemed safe by many organizations, 

12 such as WHO, FDA, et cetera.

13 We understand that carrageenan has even 

14 been approved for use in infant formulas, and 

15 infants are the most susceptible and vulnerable 

16 individuals. The, quote/unquote, "research" 

17 indicating that carrageenan can cause tumors or 

18 cancer was based on synthetic, manmade, 

19 short-chain, low-molecular weight called 

20 poligeenan, often referred to as degraded 

21 carrageenan.

22 So, for carrageenan to function in food 
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1 applications, including our application, it has to 

2 be the long-chain, the way it is found naturally. 

3 Consumers are looking for natural, organic, 

4 healthy ingredients.

5 (Timer rings.)

6 In the world of softgel manufacturing, 

7 carrageenan is the only ingredient that fulfills 

8 the functional requirements and consumer demands.

9 Thank you.

10 Any questions?

11 CHAIR FAVRE: Questions?

12 Harold?

13 MEMBER AUSTIN: As part of your 

14 manufacturing process protocol doing the research 

15 to look at the development of your softgel and 

16 stuff, how extensive was the human and the 

17 environmental health impact research that you did 

18 as part of your formulation process?

19 MR. UNG: Well, we are a contract 

20 manufacturer. We respond to our customer demands 

21 and requirements. So, we look more technically at 

22 the ability to manufacture products.
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1 Sustainability is an important issue, 

2 and our understanding is that carrageenan, the 

3 specific species used is a very sustainable 

4 product. But I wouldn't say it is at the top of 

5 the list, so to speak, with our particular 

6 customers, but it is something that they ask about.

7 CHAIR FAVRE: Lisa?

8 MEMBER DE LIMA: Hi.

9 MR. UNG: Hello.

10 MEMBER DE LIMA: So, in the beginning 

11 of your presentation, you said something to the 

12 effect of a large-scale manufacturing, something 

13 about the volume which was necessitating the 

14 carrageenan for softgel vegetarian caps?

15 MR. UNG: Yes. Correct.

16 MEMBER DE LIMA: Because my 

17 understanding is there are a number of softgel 

18 vegetarian caps that don't contain carrageenan.

19 MR. UNG: Well, okay, so it is really 

20 in the technical application. So, for example, 

21 some of the starch alternatives, you can only make 

22 a small capsule. Once you get into the larger 
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1 sizes, it just doesn't work. The stability is not 

2 there. It leaks. It is fragile. So, 

3 carrageenan is the only substance that we can use 

4 to give us the size range from very small capsules 

5 to very large capsules.

6 MEMBER DE LIMA: So, would one 

7 alternative for a manufacturer be to produce 

8 smaller capsules without the carrageenan and 

9 increase the dosage, the number of caps a person 

10 would need to take to get their dose per day?

11 MR. UNG: Sure. I mean, yes, I think 

12 these are driven by consumer demands. Well, from 

13 what our customers are telling us, they would 

14 prefer one or two softgels rather than five-six 

15 serving size.

16 CHAIR FAVRE: Thank you very much.

17 Oh, sorry. Harriet?

18 MEMBER BEHAR: Are there any currently 

19 certified organic products that are using your 

20 capsules?

21 MR. UNG: Currently, not to our 

22 knowledge as a finished product. The reason being 
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1 is another ingredient that is used in the 

2 manufacture of these capsules, I don't believe it 

3 is organic-certified, but I think it is something 

4 that we are working on.

5 There are a lot of questions that 

6 revolve around that. You know, can the finished 

7 product be organic-certified? And that is 

8 something that we are working towards.

9 CHAIR FAVRE: Anybody else?

10 (No response.)

11 Thank you very much.

12 MR. UNG: Thank you.

13 CHAIR FAVRE: Next up is John Ashby, 

14 followed by Peter Barbera on deck.

15 MR. ASHBY: I'm John Ashby. I have 

16 three comments.

17 My first haiku: Si02, yes.

18 (Laughter.)

19 Or we make no more solids; lysols don't 

20 fix all.

21 We invented organic syrup solids 

22 decades ago. No silicon dioxide, no more organic 
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1 syrup solids. Written comments and other comments 

2 given earlier explain why.

3 The next haiku: sanitizers more; FSMA 

4 means it "or you're closed". No excuses at all. 

5 Or, the sub-haiku: grow up, organics, embrace our 

6 strengthened presence or we could disappear. 

7 Don't wait; don't dawdle; approve sanitizers.

8 I live in Davis where there is UC Davis. 

9 The campus is completely supported to such an 

10 extent by GMO funding. I know these people. 

11 They, frankly, expect us to self-destruct, 

12 consider us no threat because of that expectation. 

13 And eliminating sanitizers is probably one of the 

14 quickest ways to take us down.

15 WWMWUTD, okay, that is kind of long. 

16 It's: what would Monsanto want us to do? Every 

17 time we do something like eliminate a sanitizer, 

18 we are doing the devil's -- I mean Monsanto's work.

19 Now I need to respond. I was offended 

20 yesterday by the use of a four-letter word. To 

21 respond, I have to say it.

22 My final haiku, well, sort of. Here it 
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1 comes: OMRI's not evil. Substance evaluation, 

2 it's what OMRI does.

3 We had OMRI up on the projector, and 

4 evaluating substances was presented as a negative. 

5 The money we bring in was presented as something 

6 almost evil. I'm here to confess, yes, we bring 

7 in money -- to pay, reasonably and with good 

8 benefits, our staff who evaluates materials for the 

9 organic community with, I might add, total 

10 transparency of process.

11 All the work I have done, gladly, for 

12 OMRI has been for zero money. Okay, not completely 

13 gladly, but a free glass of wine here and there.

14 (Laughter.)

15 P.S., Peggy, OMRI's CEO, is also not 

16 evil. And if she was, frankly, that would be my 

17 fault since I have been --

18 (Mr. Ashby's cell phone rings.)

19 There's my barking dogs (referring to 

20 phone ring).

21 (Laughter.)

22 Since I have been multiple times Board 
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1 Chairman, frankly, if she and OMRI were not 

2 exquisite, it would be my fault, and my integrity 

3 would have required me to correct it. Instead, I 

4 get to pretend to be worthy of credit for what we 

5 do.

6 Final haiku: organic must grow or we 

7 haven't done our jobs, so we must be wise.

8 CHAIR FAVRE: Questions?

9 Since it's impossible to follow 

10 that -- (laughter) -- it is difficult for us to ask 

11 a question.

12 Jean? The only one brave enough to ask 

13 a question.

14 MEMBER RICHARDSON: I can't ask a 

15 question because I only have iambic pentameter.

16 (Laughter.)

17 CHAIR FAVRE: Harold?

18 MEMBER AUSTIN: Point of order. A 

19 question will have to be in the form of a haiku? 

20 Okay, then I'm going to retract my question.

21 (Laughter.)

22 John, eloquent, as always.
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1 Could you explain the value to all of 

2 us of having multiple sanitizers and why 

3 restricting the number of sanitizers that we 

4 currently have available is such a detriment to the 

5 growth of organics as we move forward?

6 MR. ASHBY: Yes. You know, different 

7 things just work differently in different 

8 situations. And the days of cutting corners on 

9 this kind of stuff are just gone. I mean, my God, 

10 we had a melon farmer go to jail for insufficiently 

11 sanitizing their melons. I mean, there just are 

12 no excuses with this, with FSMA now.

13 It is getting to the point where, if the 

14 tools get too thin, I could imagine a situation 

15 where you are getting an FDA inspection, which 

16 frightens us a little less than others because FDA, 

17 for other things that we do, is in our plant every 

18 single day by design.

19 But they could look and say, "We know 

20 this isn't a sufficient way to deal with it. You 

21 have to do it differently."

22 We could say, "Well, organic doesn't 
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1 let us use that tool."

2 And they could say, "Then you can't make 

3 it."

4 I mean, things just have different 

5 functionalities, and you have got to have enough 

6 tools to deal with it or we are doing Monsanto's 

7 work.

8 CHAIR FAVRE: Thank you very much.

9 (Applause.)

10 Next up is Peter Barbera.

11 MR. BARBERA: Barbera.

12 CHAIR FAVRE: On deck is Garth Kahl.

13 MR. BARBERA: Thank you and good 

14 morning. I'm not going to try to follow that at 

15 all.

16 My name is Peter Barbera, and I'm the 

17 General Manager of Shoreside Organics in 

18 Narragansett, Rhode Island. I come to you with our 

19 petition to add squid and squid byproducts 

20 stabilized with acid to the National List.

21 I would like to address a concern 

22 regarding the health of the squid fishery. The 
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1 East Coast squid fishery is regulated under the 

2 Magnuson-Stevens Act and controlled by the 

3 National Marine Fisheries Service, the 

4 Mid-Atlantic Fishery Marine Council, and in Rhode 

5 Island, the Department of Environmental 

6 Management.

7 It is a highly-regulated fishery and 

8 has been for many years. The National Marine 

9 Fisheries Services has stated that overfishing is 

10 not occurring in the East Coast squid fishery and 

11 it has not exceeded its quota for the past 10 years.

12 The economics of squid fertilizer make 

13 it not possible to develop a fishery for 

14 fertilizer. Squid is a very valuable product, 

15 whole squid. Nor would the National Marine 

16 Fisheries Service allow it. It works only by 

17 getting squid waste for free or a small token 

18 amount. The saving is on the other end with no 

19 trucking or landfill cost to the processor.

20 The second concern of the whole squid, 

21 I specifically added whole squid because in every 

22 load of squid waste we receive, we get a very small 
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1 percentage of whole squid. Squid cleaning is done 

2 by hand, and a full whole squid accidentally slip 

3 by during the process. That percentage is less 

4 than one-quarter of 1 percent.

5 Also, on rare occasions, squid is unfit 

6 for human consumption, the reasons ranging from 

7 being out to sea too long, equipment or vessel 

8 breakdown, and weather. This unusable squid would 

9 end up in landfills instead of being 

10 beneficially-used on crops. Heavy metals, on our 

11 squid fertilizer analysis we have done, compared 

12 to most fish fertilizers show less heavy metal 

13 concentrates. By adding squid and squid 

14 byproducts to the National List, it would greatly 

15 reduce the waste streams going to landfill, which 

16 can lead to runoff issues.

17 Using 100 percent of this squid for both 

18 human consumption and fertilizer is in the spirit 

19 of organics and living in a world of reduced waste 

20 and full resource utilization. As finfish 

21 byproducts are increasingly used to make animal and 

22 aquaculture feed, squid fertilizer can help offset 
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1 this.

2 Squid is a natural organism that has 

3 good source of macro and micro nutrients for plant 

4 growth. It has been used for centuries as a 

5 fertilizer. Our squid fertilizer has a 

6 USDA-certified bio-based product certification. 

7 We feel that squid fertilizer would be beneficial 

8 to the organic farming community and respectfully 

9 ask that your approval to add squid and squid 

10 byproducts stabilized with acids to a National 

11 List.

12 Thank you.

13 CHAIR FAVRE: Emily? Followed by Zea.

14 MEMBER OAKLEY: You talked about whole 

15 squid or unusable squid being in the byproducts. 

16 Couldn't those just be considered by products since 

17 they're coming as a result of the manufacturing and 

18 grading process?

19 MR. BARBERA: When I say they are in 

20 there, by the time we get the product, the squid 

21 byproduct or waste, you know, there is a few whole 

22 squid. But, technically, it is a waste now or 
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1 byproduct that has gone through the processing, but 

2 we are just worried, technically, if somebody came 

3 in and said, "Oh, you've got a whole squid in there, 

4 that you're out of regulation. It can only be a 

5 byproduct."

6 And we run into times, and typically, 

7 if a trip comes in with 20,000 pounds of squid, in 

8 the rare occasion that there is squid that is unfit 

9 for human consumption, it is usually only 2 or 3 

10 thousand maybe the first part of the trip that had 

11 gone bad, because sometimes they have been out a 

12 little too long. But, like I say, squid is very 

13 valuable. Neither the fisherman nor the processor 

14 wants to see squid going to fertilizer.

15 MEMBER OAKLEY: Can I clarify that, 

16 then? So, what I am hearing is that those whole 

17 squid are byproducts. Would you say that is 

18 correct?

19 MR. BARBERA: Yes, they are whole 

20 squid. When we consider byproducts, what we are 

21 getting, we are getting the guts, the wings, the 

22 skin. We are getting the waste.
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1 When you make a calamari out of whole 

2 squid that you get in the restaurants, there's 

3 about 50-percent waste left over that ends up in 

4 landfills or trucked.

5 CHAIR FAVRE: Zea?

6 MEMBER SONNABEND: Thank you.

7 We appreciate that this squid that you 

8 catch in the Eastern Atlantic, or I guess it's the 

9 Western Atlantic, but it is the East Coast of 

10 America, is only for food and that, therefore, both 

11 the whole squid that you bring in and the byproducts 

12 are considered byproducts because your purpose for 

13 catching the squid is for processing, not for 

14 fertilizer.

15 But we have to evaluate the squid that 

16 might come from other regions also. And I am 

17 wondering how familiar you are with any other areas 

18 where squid are fished or -- I can't say "squid 

19 fishing" -- squid crustaceaning. No. What are 

20 squid?

21 (Laughter.)

22 Anyway, catching squid from other 
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1 regions, if there are any areas of the world where 

2 they are caught specifically for fertilizer or 

3 whether it is always for food processing.

4 MR. BARBERA: I have not heard of 

5 anyplace in the world that uses squid for 

6 fertilizer, you know, specifically when they catch 

7 it. The only other that I have some familiarity 

8 with is the West Coast. And again, squid has 

9 become a very valuable commodity. I know, also, 

10 that they take some of their waste, but I have not 

11 heard that they take whole squid. Whole squid is 

12 over $1 a pound for the product. A fisherman, if 

13 you ever said, "I'm taking your trip and going to 

14 turn it into fertilizer and you're going to get 2 

15 cents," they would shoot me.

16 CHAIR FAVRE: So, I have a question for 

17 you. Some of the public comments indicated that 

18 there is a high percentage of unreported harvesting 

19 of squid. And so, from a natural resource 

20 management, there are some concerns associated 

21 with that. Can you speak to that? Do you have any 

22 knowledge of that at all?
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1 MR. BARBERA: I do. I have been in the 

2 fishing industry for 40 years now of my life. On 

3 the East Coast and on the West Coast, the United 

4 States, there is very, very little. To say there 

5 is zero overfishing going on anywhere, nobody can 

6 say that. There's some cheating going on.

7 But the squid fishery on the East Coast, 

8 and the same thing on the West Coast, is highly 

9 regulated. The enforcement is there. There's 

10 onboard monitors. So, there is very little.

11 And as I have stated, and I talked with 

12 the folks from the National Marine Fisheries 

13 Service before I came here, there hasn't been 

14 squid -- as a matter of fact, there's some years 

15 the squid quota that is the allowable catch for the 

16 fisherman is not even caught.

17 Now overseas, I can't really speak for 

18 that. I think most of the comments talked about 

19 overseas fishing where there was overfishing and 

20 not heavy oversight. That I can't speak on. That 

21 is something that, you know, I know the United 

22 States puts pressure on other countries to stop 
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1 overfishing. How successful they are I'm not 

2 sure.

3 CHAIR FAVRE: Harriet?

4 MEMBER BEHAR: In the technical 

5 review, it spoke a lot about the byproduct also 

6 being dumped out in the ocean, besides just 

7 landfilling. Can you speak to the environmental 

8 impacts of that type of disposal?

9 MR. BARBERA: This is going back about 

10 15-18 years ago. When squid first started to be 

11 used for the calamari in the United States, 

12 especially on the East Coast, prior to that, all 

13 our squid was sold whole, most of it overseas. 

14 This is going back like 25 years, where the foreign 

15 countries used a lot of squid for food.

16 But, as the United States started to 

17 come around and using squid, all of a sudden, of 

18 course, processors started to clean squid. What 

19 happened is many places we overwhelmed the waste 

20 treatment plants. The high biological content 

21 caused havoc.

22 We received from EPA permission to go 
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1 take squid waste out to sea. We had to travel about 

2 12 miles out, and there was certain protocol on how 

3 fast you had to go to dump it and how much area you 

4 had to cover. But they have stopped that.

5 Some of the reason, too, was, no matter 

6 what, if you are doing high volume of squid, the 

7 concentrate of squid and, you know, the nutrients 

8 that are released and what that does to the water 

9 can cause problems. To do it in a concentrated 

10 area, large volumes of squid waste in a 

11 concentrated area would cause environmental 

12 problems.

13 CHAIR FAVRE: Scott?

14 MEMBER RICE: On that note of the 

15 nutrient loading, either in the sea or as an input, 

16 what is the profile as far as nitrogen content?

17 MR. BARBERA: About 2 percent.

18 MEMBER RICE: So, would you say that is 

19 fairly low?

20 MR. BARBERA: As an organic -- if it was 

21 a chemical synthetic, it is fairly low -- but for 

22 an organic product, you know, that is in the range 
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1 without adding. You know, that is not without 

2 adding anything to boost it.

3 MEMBER RICE: Thanks.

4 CHAIR FAVRE: Harriet?

5 MEMBER BEHAR: So, it seems part of the 

6 reason that we are considering this product is 

7 because we have an issue with disposal. And so, 

8 we want to take this byproduct. And it can be a 

9 beneficial fertilizer, but, really, part of it is 

10 that we are reacting to a disposal problem, that 

11 we don't want to put it in the oceans and we don't 

12 want to put it in the landfills.

13 MR. BARBERA: Yes, that is one thing. 

14 When we first started this project -- like I say, 

15 we are in the fishing industry. We produce squid; 

16 we process squid. We see all this; we have seen 

17 this waste stream.

18 The University of Rhode Island worked 

19 with us. Dr. Chong Lee, who has been working on 

20 squid fertilizers and squid waste for many, many 

21 years, talked to us about this project, as a matter 

22 of fact, years ago.
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1 We were under the assumption that it was 

2 squid. We consider, when we go fishing, we are 

3 squid fishing; we are cod fishing. So that we were 

4 just going to be able to use it because fish 

5 byproducts in fish fertilizers is approved for an 

6 organic input. Little did we know that, once we 

7 get started, that squid and fish are not the same 

8 thing.

9 But, yes, I would say both thing. We 

10 have a byproduct that can be used in the organic 

11 community, and we also have a wastewater issue, a 

12 waste stream issue.

13 CHAIR FAVRE: Francis? And I think we 

14 will need to make this the last question.

15 MEMBER THICKE: So, why is it going to 

16 the landfill? Why don't conventional farmers use 

17 it?

18 MR. BARBERA: Well, I think synthetic 

19 fertilizers, I think if you are not in organic, 

20 unless you have, just a sad thing, that you want 

21 to be environmentally-sound, I think fertilizers 

22 are much cheaper, synthetic fertilizers; that to 
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1 compete in the synthetic market with a 2-2-2 

2 product, that we have a liquid, would some do it? 

3 I think there are some small farmers who are 

4 actually in Rhode Island who do use squid 

5 fertilizer, but the big boys are not using it.

6 CHAIR FAVRE: Thank you very much.

7 MR. BARBERA: Thank you.

8 CHAIR FAVRE: Next up is Garth Kahl, 

9 with Scott Rangus on deck.

10 MR. KAHL: Hi. My name is Garth Kahl. 

11 I'm a mixed crop and livestock producer, certified 

12 organic for 23 years in western Oregon. I have 

13 submitted my written comments on a range of issues, 

14 but today I specifically want to talk about the 

15 parasiticide issue, particularly with respect to 

16 small ruminants.

17 And if you are talking about small 

18 ruminant production in North America, this 

19 organism is your big, bad guy. This is Haemonchus 

20 contortus. It is the biggest barrier to small 

21 ruminant production, conventional and organic, in 

22 North America, also known as the barber pole worm 
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1 because of the little stripes that you see on it 

2 there.

3 So, here, really quickly, is the life 

4 cycle of Haemonchus. It goes into the sheep or 

5 goat. It goes into the abomosum, the fourth 

6 stomach of the organism. The parasites grow to 

7 adulthood. They are passed out onto the grass, and 

8 then, they can develop there and they can remain 

9 viable for up to six months, which means combating 

10 it with solely rotation of pastures is really, 

11 really impossible for most growers because they 

12 don't have the space to have that long of a 

13 rotation.

14 Here is a picture of what the infectious 

15 larvae look like. This is a third-stage instar of 

16 Haemonchus just waiting to be eaten by a 

17 susceptible young lamb or a ewe whose resistance 

18 is down because she has just lambed and she is 

19 lactating, and her resistance is low.

20 This is what Haemonchus does in the 

21 abomosum. It goes in and it actually pierces the 

22 wall of abomosum, and they are blood-sucking 
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1 parasites. And they generally reduce 

2 thriftiness; they reduce weight gain; they can 

3 cause abortions. In severe cases you get this. 

4 This is bottle jaw.

5 So, if you, as an organic inspector or 

6 you, members of the NOSB, are looking for an 

7 indicator of what is emergency use, if you see an 

8 animal with this, this animal is critical. It 

9 could die in days or weeks. This is caused by 

10 buildup of fluids underneath the jaw, and you also 

11 get anemia. And I will talk about that in a second.

12 So, treatment strategies. On our farm 

13 we use multi-species grazing to try to break the 

14 life cycle, so the cattle eat the organism and it 

15 is a biological dead-end.

16 This is also key, and this is being 

17 used, conventional and organic. This is the 

18 FAMANCHA test. It is a test for anemia. 

19 Basically, you look at the upper lefthand corner 

20 of the slide there. If the animal's eye is white 

21 there, that is an emergency treatment protocol, 

22 basically. If your animal is that anemic, you need 
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1 to do something.

2 So, we used approved herbal and 

3 homeopathic wormers, but we also use judicial use 

4 of parasiticides as a last resort. And we are 

5 seeing resistance, both conventional and organic, 

6 to fenbendazole. So, this is why I would ask you 

7 to please keep ivermectin and the whole slew of 

8 options on the list.

9 (Timer rings.)

10 And I would welcome any questions.

11 CHAIR FAVRE: Questions?

12 Jean?

13 MEMBER RICHARDSON: So, you know we're 

14 struggling with the ivermectin, Garth. Have you 

15 used ivermectin very much on your sheep? Have you 

16 seen any negative dung beetle impact on your farm 

17 or the ones in your region?

18 MR. KAHL: Well, yes, first of all, I 

19 do use ivermectin on the sheep and I will use it 

20 on non-lactating goats. Basically, the way you 

21 use ivermectin -- and this is now recommended to 

22 us both conventional, this is what Extension is 
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1 recommending, and also, obviously in organic -- you 

2 don't treat the whole herd. You treat maybe 20 

3 percent of the herd.

4 You use the FAMANCHA test. And I 

5 didn't put a slide in there. We also use fecal eggs 

6 counts. So, you're only treating, the rule of 

7 thumb is you have 80 percent of the parasites in 

8 20 percent of the animals. So, you're treating 

9 those animals that show up with a severe FAMANCHA 

10 test. Nobody is recommending, conventional or 

11 organic, to treat the whole herd because that is 

12 how you build up resistance.

13 So, you use a FAMANCHA test. You check 

14 body conditioning score. And you treat those 

15 animals that are very susceptible, that have a low 

16 body conditioning score and a bad FAMANCHA test. 

17 So, you are only treating at the most 20 percent 

18 of your herd. You are also providing refugia for 

19 dung beetles in the other 80 percent of the herd.

20 The other thing is we don't use 

21 ivermectin or any parasiticides on our cattle in 

22 our area. We don't have lungworm in the western 
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1 U.S., and the WODPA people could probably add to 

2 this. But we don't have as big a parasite load in 

3 large ruminants as other areas of the country.

4 Basically, what I am saying is dung 

5 beetle can live in 80 percent of the patties out 

6 there. There's 20 percent that might have 

7 ivermectin in them.

8 CHAIR FAVRE: Any other questions?

9 (No response.)

10 MR. KAHL: Thank you.

11 CHAIR FAVRE: Thank you very much.

12 Next up is Scott Rangus, followed by 

13 Nicholas Gardner on deck.

14 MR. RANGUS: Good morning. I'm Scott 

15 Rangus. I'm the President and CEO of Ingredient 

16 Solutions. We are the largest independent 

17 supplier of carrageenan in the world, and I have 

18 been in the carrageenan business since 1976, pretty 

19 much straight of school.

20 Over the past 40 years, we have seen the 

21 attacks on carrageenan come and go over the years. 

22 Upon repeated review, every major food regulatory 
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1 ingredient agency in the world has reaffirmed that 

2 carrageenan is safe for use in food, and continues 

3 to reaffirm that even last year in infant formulas.

4 There's plenty of scientific speakers 

5 that are going to support this. So, I am not going 

6 to dwell on that, but I do want to make a few points, 

7 though.

8 The current critics of carrageenan say 

9 that, just because the world's food ingredient 

10 agencies say carrageenan is safe, the theory is, 

11 well, industry and government are in collusion. 

12 Does anybody really believe that in the entire 

13 world that this is all a big conspiracy between the 

14 food agencies and the carrageenan industry? That 

15 just doesn't make a lot of sense.

16 The next criticism is that the 

17 carrageenan industry, you know, any of the studies 

18 that are supporting carrageenan are funded by the 

19 industry. Well, the reason for that is the 

20 ingredient industry doesn't have the luxury of 

21 grants that are paid for by taxpayers to continue 

22 these programs to attack carrageenan and other food 
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1 ingredients. It is not just carrageenan.

2 As long as the grant money is flowing, 

3 this has become a career for some researchers, and 

4 they will just generate more theories, do some 

5 research, publish a paper, and the social media 

6 keeps it going.

7 I wasn't here yesterday, but I heard 

8 that there was somebody citing 1300 anecdotal cases 

9 of carrageenan "giving me a tummy ache". Well, I 

10 would argue that, in a country of 320 million 

11 people, you could pick any food or food ingredient 

12 and find at least that many who claim that "this 

13 doesn't agree with me," whether it is true or not. 

14 That is a point.

15 Now, in support of carrageenan, 

16 carrageenan provides a livelihood, the seaweed 

17 farming part, for over 100,000 families in Asia, 

18 the Philippines, Indonesia, and other parts of the 

19 world. This is an industry that provides a 

20 livelihood that wouldn't exist otherwise.

21 The carrageenan seaweeds are farmed 

22 without the use of pesticides, without the use of 
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1 fertilizers. And without the current critics, it 

2 would be considered the ideal sustainable food 

3 ingredient of the 21st century.

4 Keeping carrageenan on the organic list 

5 I think gives the organic producer at least the 

6 option.

7 (Timer rings.)

8 It is still their choice whether to use 

9 it or not, but it should remain at least an option. 

10 Let them decide if they want to keep it or not.

11 Thank you.

12 Questions?

13 CHAIR FAVRE: Jean? And then, 

14 Harriet.

15 MEMBER RICHARDSON: Are you someone I 

16 could ask about overharvesting, a question?

17 MR. RANGUS: Overharvesting? There 

18 is so much tidal waters available in the 

19 Philippines, Indonesia, some in Africa, that these 

20 are continuously planted and harvested.

21 MEMBER RICHARDSON: Okay. So, that is 

22 kind of my question.
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1 MR. RANGUS: Yes.

2 MEMBER RICHARDSON: Let me try to, 

3 then, phrase the question the way I want it. It 

4 is that I have observed Irish moss, as it is called 

5 in Canada, being overharvested, Prince Edward 

6 Island, Nova Scotia, a huge impact.

7 MR. RANGUS: Yes.

8 MEMBER RICHARDSON: So, could you help 

9 me to understand? Because, obviously, we have to 

10 make a decision on this that works internationally 

11 and not just for one part of the world. How much 

12 carrageenan today going into industry is from the 

13 red algae that have actually been farmed --

14 MR. RANGUS: Right.

15 MEMBER RICHARDSON: -- and therefore, 

16 more under control, as opposed to the wild 

17 harvesting, which has obviously had a negative 

18 impact over the years?

19 MR. RANGUS: Yes. The Irish moss was 

20 the original source of carrageenan, going back to 

21 the 1800s, when somebody found out they could boil 

22 it. Now why anybody would do this, I have no idea, 
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1 but somebody figured out that they could boil Irish 

2 moss with milk and strain out the seaweed, and it 

3 would set into a custard. Now why anybody would 

4 even think to try that is anybody's guess, but that 

5 was how carrageenan was originally discovered.

6 And that is why most of the carrageenan 

7 processing plants all were built along the North 

8 Atlantic Coast from the U.S. through Europe. The 

9 natural harvest of Irish moss has been replaced by 

10 the farming, mostly in the Philippines and 

11 Indonesia, of seaweeds that are much more 

12 economically. So, these days there is relatively 

13 little harvesting of Irish moss from the North 

14 Atlantic Region, simply because it has been 

15 replaced by more economically sources. So, the 

16 cost of harvesting the Irish moss is quite high.

17 So, just from an economic standpoint, 

18 there is very little of that done. And the farming 

19 that is done in other parts of the world, it is about 

20 as environmentally-friendly and sustainable as 

21 you're going to find of any raw material that you 

22 would grow.
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1 MEMBER RICHARDSON: So, what 

2 percentage is farmed?

3 MR. RANGUS: Oh, boy, I would have to 

4 say it is like 98 percent plus. There is very 

5 little of the Irish moss. Now there is natural 

6 seaweed harvesting in Chile of a different type for 

7 a different type of carrageenan. But, again, that 

8 is a natural harvest. It is harvested something 

9 like kelp, where it is essentially raked, but only 

10 the top part of the plant is taken from under the 

11 water. And it just grows back. There is no damage 

12 to the seabed or coral in the case of the Chilean 

13 weed.

14 In the case of the farmed stuff in the 

15 Philippines and Indonesia, there is virtually no 

16 effect on the environment there, no fertilizers, 

17 no pesticides. It would be like the ideal 

18 ingredient. It is totally sustainable, provides 

19 a livelihood, and it has replaced in those regions' 

20 destructive fishing practices as a means of making 

21 a living.

22 So, people can grow seaweed instead of 
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1 fishing out an area or using things like dynamite. 

2 They used to use dynamite, throw it in the water, 

3 explode it, and the fish would float to the surface. 

4 That was not a very environmentally-friendly 

5 practice, and that has been replaced by seaweed 

6 farming in these areas now.

7 My point is, you know, let the organic 

8 food producer make their own decisions. But the 

9 idea of the food regulatory agencies worldwide are 

10 in some great conspiracy with the carrageenan 

11 industry just doesn't make any sense.

12 CHAIR FAVRE: Harriet?

13 MEMBER BEHAR: Jean mostly asked the 

14 question, but I am going to do a follow-up. The 

15 carrageenan or the seaweed that they are planting, 

16 is that a native seaweed --

17 MR. RANGUS: Oh, yes.

18 MEMBER BEHAR: -- or are they using 

19 North Atlantic seaweed in --

20 MR. RANGUS: No, no.

21 MEMBER BEHAR: This is a seaweed that 

22 is native to that area?
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1 MR. RANGUS: Yes. Well, you have to 

2 farm the seaweed in the areas that it grows 

3 naturally.

4 MEMBER BEHAR: Uh-hum.

5 MR. RANGUS: Decades ago, these were 

6 also gathered naturally. They just picked them 

7 off the ocean floor. But what has replaced that 

8 is, basically, you put lines in the water with 

9 cuttings. You take little seedlings, tie them 

10 off. This is why you get like multi-generational 

11 farming families. You see everything from 

12 grandparents to little kids involved, and the 

13 government grants each farming family a certain 

14 area of hectares of water to use for their little 

15 farms. And these are all private. They say 

16 there's over 100,000 families involved in growing 

17 this. And all those seaweeds are indigenous to the 

18 areas they are farmed in; they have to be because 

19 the North Atlantic seaweed is not going to grow in 

20 the Philippines. It is too hot, a number of 

21 reasons.

22 But, yes, what happens is you put a 
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1 little seedling on a line. Those things in four 

2 to six weeks grow to a 2- to 3-foot plant. They 

3 are harvested, and the process starts all over, 

4 taking the cuttings and putting them back on new 

5 lines. And this just goes on 12 months of the year. 

6 It is a year-found harvest.

7 MEMBER BEHAR: So, is it still the red 

8 algae?

9 MR. RANGUS: Oh, it is still, yes, the 

10 red seaweeds are the source for carrageenan and 

11 agar.

12 MEMBER BEHAR: Okay.

13 MR. RANGUS: And then, brown seaweeds, 

14 these are the marine kind of group families. The 

15 brown seaweeds are the alginate. That is the stuff 

16 you see on the beach in California, kelp.

17 CHAIR FAVRE: A-dea?

18 MEMBER ROMERO-BRIONES: Can you 

19 explain the economics of carrageenan for the 

20 farming families? We have heard a lot about 

21 carrageenan being the livelihood for many farmers 

22 around the world. How much are the farmers given 
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1 for, let's say, a pound of carrageenan?

2 MR. RANGUS: Okay. We have a 

3 speaker -- actually, the reason I am not going to 

4 answer that is because I don't want to give you the 

5 wrong information. But the seaweed in general, 

6 depending on the type, especially in the 

7 Philippines and Indonesia, sells from anywhere on 

8 the market for $500 to $1200 per metric ton.

9 Now how much each family can farm and 

10 produce, I'm not sure of the exact number, but we 

11 do have a speaker from the Philippines coming up 

12 later, and she can probably can answer that 

13 question more. I don't want to give you the wrong 

14 information.

15 But it is quite a good livelihood. It 

16 is year-around. And they say it has replaced the 

17 destructive fishing practice that were common 

18 before seaweed farming became more popular as a 

19 living.

20 CHAIR FAVRE: Last question, Lisa.

21 MEMBER DE LIMA: Do you know what 

22 percentage of carrageenan goes into conventional 
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1 products versus organic products?

2 MR. RANGUS: Oh, conventional 

3 products, again, it is the vast majority goes into 

4 conventional food products, dairy, meat, and we had 

5 a speaker from Best Products making the softgel 

6 capsules, everything from toothpaste, even the 

7 solid air-freshener gels that you buy in the store, 

8 the little cones, those are carrageenan gels. A 

9 lot of people don't even know that.

10 But the organic market is very small, 

11 probably less than 5 percent, to be honest with you. 

12 But it is an important -- it is a beachhead, if you 

13 will.

14 The only thing I would like to leave you 

15 with is, you know, if you are going to review things 

16 like carrageenan or any ingredient, do it on the 

17 basis of science and don't let social media drive 

18 this, which is kind of what we are seeing every day.

19 This is what is different now than 20 

20 or 30 years ago. You didn't have the bloggers and 

21 the social media. Let's face it, the average 

22 consumer is not a scientist. So, they read 
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1 something, "Oh, this must be true." They jump on 

2 the bandwagon and it goes from there.

3 You can accuse somebody of anything. 

4 What happens is, then, the obligation falls on us 

5 to defend ourselves, whether the accusation is 

6 accurate or not. And that has been the problem. 

7 That is why we are addressing this so aggressively, 

8 because we can't just wait for it to go away, as 

9 it has over the past decades. These accusations 

10 come and go. They get disproven, and we move on.

11 That is we have to do it today. We 

12 can't just say, "Well, this will blow over." You 

13 can't just assume that anymore.

14 CHAIR FAVRE: Thank you very much.

15 MR. RANGUS: All right. Thank you.

16 CHAIR FAVRE: Next up is Nicholas 

17 Gardner, followed by Anicia Hurtado.

18 MR. GARDNER: Good morning. My name 

19 is Nicholas Gardner, and I am commenting on behalf 

20 of Marinalg International. Marinalg is a trade 

21 association representing companies that produce 

22 seaweed-derived hydrocolloids, including 
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1 carrageenan.

2 Marinalg strongly supports the 

3 continued listing of carrageenan on the National 

4 List at 205.605(a). Carrageenan is a 

5 non-synthetic, high-molecular-weight 

6 polysaccharide extracted from red seaweed.

7 Carrageenan has been safely used in 

8 foods for hundreds of years because of its unique 

9 functionality. Carrageenan is commonly used to 

10 thicken, stabilize, bind water, promote gel 

11 formation, and is a substitute for fat. 

12 Carrageenan improves palatability, appearance, 

13 consistency, and stability of nutrients in a long 

14 list of organic and conventional foods, including 

15 dairy products, dessert gels, meat and fish 

16 products, beverages, condiments, infant formula, 

17 and even pet food. Although alternatives have 

18 worked for some products, we disagree with claims 

19 that alternatives exist for all organic 

20 applications.

21 Carrageenan is, first and foremost, a 

22 safe ingredient. Extensive scientific research 
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1 demonstrates that carrageenan does not cause 

2 adverse health impacts when consumed in food.

3 Perhaps the most significant indicator 

4 of the global consensus on carrageenan safety is 

5 the recent evaluation of carrageenan for use in 

6 infant formula and formulas for special medical 

7 purposes by JECFA.

8 JECFA is one of the most respected 

9 risk-assessment bodies in the world and it is used 

10 by Codex and nations around the world to manage 

11 risks. JECFA's conclusions are unambiguous. 

12 Carrageenan is safe for use in products for 

13 infants. It is unlikely to be absorbed in the 

14 body. And JECFA's review of the toxicological 

15 database on carrageenan did not indicate other 

16 toxicological concerns.

17 Some have tried to raise uncertainty 

18 about carrageenan by claiming that carrageenan 

19 contains poligeenan or equating carrageenan to 

20 poligeenan. I want to be very clear. Carrageenan 

21 is not poligeenan. Poligeenan is an entirely 

22 different substance. Food-grade carrageenan does 
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1 not include or degrade into carrageenan in the 

2 body, and we need to judge carrageenan's safety 

3 based upon research on carrageenan, not 

4 poligeenan.

5 Let me just touch on a couple of 

6 remaining points in the time I have. Carrageenan 

7 is essential to organic production and cannot be 

8 replaced in all products. While some companies 

9 have found substitutes for certain products, there 

10 are examples where reformulation is not possible 

11 or would result in inferior products.

12 Carrageenan is consistent with organic 

13 principles, including the seaweed farming that you 

14 just heard about. And the concept of carrageenan 

15 sensitivity has not been demonstrated, but if it 

16 does exist, you can avoid carrageenan by reviewing 

17 food labels. All processed packaged foods that 

18 use carrageenan will have carrageenan listed on the

19 label.

20 Thank you very much. I would be happy 

21 to take any questions.

22 (Timer rings.)
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1 CHAIR FAVRE: Oh, good job.

2 (Laughter.)

3 Tom, you had a question?

4 VICE CHAIR CHAPMAN: I've got a couple, 

5 actually.

6 I mean, you made two statements in there 

7 about organic products requiring carrageenan.

8 MR. GARDNER: Yes.

9 VICE CHAIR CHAPMAN: Do you have 

10 examples of categories?

11 MR. GARDNER: Yes, and I was hoping, 

12 actually, Tom, you would ask me this question.

13 I want to talk a little bit about 

14 essentiality in framing how I respond to this 

15 question. I concede that there are substitutes 

16 for carrageenan that provide technical functions 

17 that are very similar to carrageenan. But, in my 

18 opinion, essentiality comes down to the organic 

19 formulator who has spent months or years developing 

20 a formulation where they evaluated alternatives, 

21 and they have selected carrageenan for a very 

22 specific reason or reasons.
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1 When they look at their 

2 formulation -- and we know some have tried to remove 

3 carrageenan -- they often find that using 

4 alternatives results in very negative properties 

5 that aren't present in the formulation when they 

6 use carrageenan, things like odor, color, not great 

7 mouthfeel or consistency; potentially in terms of 

8 stabilizing nutrients, not the same performance, 

9 which can be very important if you are making a 

10 nutritional beverage, for example.

11 Now could that producer create a 

12 product that has similar properties without 

13 carrageenan? Yes, that may be the case, but they 

14 are really forming products to satisfy their 

15 consumer. And if they are faced with the choice 

16 of formulating a product that their consumers don't 

17 want that has an organic label on it or using 

18 carrageenan and, say, forming a conventional food 

19 that has a natural label on it that will sell, that 

20 formulator will likely go for the conventional food 

21 product that sells that their consumers want. To 

22 them, it is really essential that they use 
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1 carrageenan, even if technical functionality may 

2 be achievable through other means.

3 Now let me just note one other point as 

4 well. This is very important for a lot of the 

5 organic formulators that we have talked to. 

6 Often, replacing carrageenan requires the use of 

7 multiple other stabilizers and thickeners. When 

8 you are thinking about formulating a product that 

9 is intended for an organic consumer that is 

10 scrutinizing food labels, is looking at all of the 

11 ingredients that go into their products, they would 

12 rather have a product that has just carrageenan in 

13 it than two or three other hydrocolloids or 

14 biopolymers that function in a system to achieve 

15 comparable functionality.

16 VICE CHAIR CHAPMAN: And follow-up to 

17 that, I mean, I hear what you are saying about the 

18 multiple substances. Unfortunately, under the 

19 OFPA criteria, one of the areas with alternatives 

20 that we are supposed to evaluate is other available 

21 materials, plural. So, the replacement of one 

22 material with multiple is still an acceptable area 
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1 of the evaluation under the OFPA criteria.

2 MR. GARDNER: Well, that is why you 

3 have the tough job.

4 VICE CHAIR CHAPMAN: Indeed.

5 (Laughter.)

6 All right. Which one do I want to 

7 follow up on first? Let's go with, you made a 

8 comment about labeled ingredients.

9 MR. GARDNER: Yes. Sure.

10 VICE CHAIR CHAPMAN: And I had asked 

11 the question on the webinar, and I don't feel like 

12 I got a clear answer. So, I am going to ask it again 

13 here.

14 In cases of products like alcohol, and 

15 particularly beer --

16 MR. GARDNER: Yes.

17 VICE CHAIR CHAPMAN: -- where 

18 carrageenan is used as a --

19 MR. GARDNER: Clarifying agent.

20 VICE CHAIR CHAPMAN: -- clarifying 

21 agent --

22 MR. GARDNER: Yes.
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1 VICE CHAIR CHAPMAN: -- it will not 

2 appear on the label.

3 MR. GARDNER: In beer, when used as a 

4 clarifying agent, it would not appear on the label. 

5 But the way a clarifying agent works is the 

6 particles in the beer that carrageenan is intended 

7 to bind with to clarify the beer are actually 

8 removed from the beer prior to marketing.

9 So, you wouldn't have carrageenan in 

10 that beer product, which is why labeling it in that 

11 application is not a concern. Also, you know, that 

12 is regulated somewhat differently than processed 

13 food products, which is I think what my comments 

14 limited them to.

15 VICE CHAIR CHAPMAN: Okay. I did 

16 remember my other follow-up. So, I am going to ask 

17 that real quick and, then, I will shut up.

18 So, you made comments about formulators 

19 and reformulation resulting in inferior products. 

20 There were several companies between the last 

21 sunset review and now --

22 MR. GARDNER: Yes.
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1 VICE CHAIR CHAPMAN: -- that have 

2 removed carrageenan from their products. Are you 

3 aware of customer complaint data or sales data, or 

4 anything like that, that supports that claim in 

5 terms of customer preference of these products?

6 MR. GARDNER: Well, the way I think I 

7 can answer that question best is by talking about 

8 some of the conversations I have had with my members 

9 who often are consulted when producers are making 

10 product reformulation decisions. I know of 

11 several instances and a variety of products that 

12 I'm not going to name here in this public forum, 

13 but several instances where formulators have come 

14 back to my members and have said, "Look, we are 

15 trying to reformulate. We have tried multiple 

16 alternative hydrocolloids, biopolymers, and 

17 really, our formulation at this point is broken. 

18 We cannot produce the product that we want with the 

19 exact characteristics that we want without 

20 carrageenan."

21 And frankly, if you asked a producer 

22 about customer acceptance, they are going to know 
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1 that a lot better than I will, representing a little 

2 further upstream.

3 CHAIR FAVRE: Okay. The last 

4 question, Zea.

5 MEMBER SONNABEND: Thank you.

6 Actually, mine is a follow-up to Tom's 

7 middle question about the beer, which I appreciate 

8 that in beer it is a processing aid, essentially. 

9 But we did get some public comment about some other 

10 ingredients, other products it didn't appear on the 

11 label, including I believe condensed milk or 

12 evaporated milk was one of them.

13 It is of some concern to us if people 

14 with sensitivity can't see it on the label. So, 

15 can you verify that?

16 MR. GARDNER: Of course. Now, I mean, 

17 I think, Zea, I would start by acknowledging that 

18 if you cannot identify something on a label that 

19 you think you are sensitive to, that is a big 

20 problem.

21 Evaporated milk or condensed milk, in 

22 either case, is going to be an FDA-regulated 
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1 product. I can't think of any instance where it 

2 would be a USDA-regulated product. But, either 

3 way, the labeling laws are quite clear. If used 

4 as a primary ingredient in those products, it has 

5 to be listed. And I really can't think of any 

6 processing use that I have ever encountered for 

7 carrageenan other than clarifying agent. It is 

8 possible they exist, but I have never encountered 

9 one.

10 MEMBER SONNABEND: Thanks.

11 CHAIR FAVRE: Thank you very much.

12 MR. GARDNER: Thank you.

13 CHAIR FAVRE: Next up is Anicia 

14 Hurtado, followed by Urvashi Rangan on deck.

15 MS. HURTADO: Good morning. I am 

16 Anicia Hurtado, a seaweed scientist with more than 

17 30 years of experience advising seaweed farmers on 

18 crop science and crop management. I am here at the 

19 request of Marinalg to speak on the importance of 

20 carrageenan being able to retain its organic status 

21 in the upcoming sunset review.

22 Two carrageenans produced are dominant 
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1 in farming. These are known as cottonii and 

2 spinosum, the former producing kappa carrageenan 

3 and the latter, iota. Each has its own markets in 

4 processed meat and dairy products.

5 Seaweed farming and carrageenan 

6 production are major revenue-producing activities 

7 in Southeast Asia. They are also major employment 

8 producers, especially for seaweed farm families.

9 In the Philippines alone there are over 

10 100,000 families engaged in seaweed farming. 

11 Prior to the introduction of seaweed cultivation 

12 in the 1960s, these coastal residents relied on 

13 declining fisheries for marginal systems. 

14 Seaweed farming has stepped in and has produced a 

15 fair and equitable income for fisher-folk.

16 Carrageenan production remains the 

17 only market for these farmed seaweeds. All 

18 carrageenan producers worldwide rely on cottonii 

19 and spinosum farms in Southeast Asia, particularly 

20 Indonesia and the Philippines. Any reduction in

21 demand for carrageenan ripples quickly down the 

22 supply chain, affecting farmers' income.
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1 Thus, even though organic carrageenan 

2 is still a small market, it is an important one. 

3 Removing it from the National List would cause 

4 undue damage to seaweed farm families.

5 Other advantages of seaweed 

6 cultivation address environmental and ecological 

7 issues. Seaweed farming perpetuates a renewable 

8 resource. It grows vegetatively. A small piece 

9 of seaweed can be suspended in coastal seawater and 

10 it will grow undiminished in time.

11 In practice, a 100-gram seedling is 

12 allowed to grow for 45 to 60 days, and it is 

13 harvestable when it has reached a weight of more 

14 than 700 grams each. A new seedling is taken from 

15 the harvest, and the whole process is repeated. 

16 Methods of suspending the seaweed and harvesting 

17 are described in detail in my written submission.

18 Seaweed farming is beneficial to the 

19 environment. It sequesters CO2 from the 

20 atmosphere. Seaweed farms provide habitats for a 

21 diversity of marine organisms, thus, increasing 

22 the biodiversity of the marine ecosystem.
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1 No pesticides or fertilizers are used, 

2 nor are they needed in seaweed farming. The sea 

3 provides all the nutrients needed for efficient 

4 seaweed cultivation. The bright tropical sun

5 provides energy for growth through photosynthesis.

6 In conclusion, my country, the 

7 Philippines, needs to have carrageenan remain on 

8 the National List.

9 (Timer rings.)

10 I hope I have given you some convincing 

11 reasons to retain carrageenan in the National List.

12 Thank you.

13 CHAIR FAVRE: Thank you.

14 Any questions?

15 Harriet?

16 MEMBER BEHAR: Everyone states that 

17 there are no pesticides or fertilizers used. In 

18 any case is there ever any used? No?

19 MS. HURTADO: There's none.

20 MEMBER BEHAR: So, there are no other 

21 sea plants being grown in that area? So, they just 

22 introduce them? Or how are they growing that 
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1 monoculture?

2 MS. HURTADO: Actually, you can 

3 cultivate the seaweeds which are endemic in that 

4 place or you can just transplant it in another 

5 place. But we never use fertilizer nor pesticides 

6 in that area. We have to depend on the nutrients 

7 present and the water column of the sea. And that 

8 is more than enough to grow the seaweed.

9 CHAIR FAVRE: Harold?

10 MEMBER AUSTIN: Thank you for coming 

11 and giving the presentation to us and providing us 

12 with this additional information.

13 A two-part question. The first part 

14 would be, in the areas where the carrageenan is 

15 being farmed, the red seaweed is being farmed, is 

16 there any noticeable changes to the biodiversity, 

17 to the plant life in those areas where these farms 

18 currently exist?

19 MS. HURTADO: Yes, because when you 

20 plant the seaweed hanging in the water column, 

21 after 15 days -- that is my personal 

22 observation -- there are a lot of juveniles, 
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1 fishes, crustaceans, even what you call finfish 

2 that are roaming around in that area. So, it is 

3 a very good mix or a habitat for the juveniles. In 

4 fact, we call it a nursery ground.

5 MEMBER AUSTIN: Okay. So, it is 

6 actually helping to improve it.

7 The other question that I have is we 

8 have heard that there's 100,000 family farms that 

9 are involved in this and roughly 5 percent of the 

10 harvest goes into organic production. So, if we 

11 did the math, we would be looking 

12 at -- what? -- 5,000 family farms that would be put 

13 out of business. What would those individuals do 

14 if they weren't able to harvest carrageenan?

15 MS. HURTADO: Oh, actually, if you go 

16 for cultivation, there is a phase. So, you have 

17 to manage your farm in such a way that every month 

18 you can harvest it. So, you have the planting and, 

19 then, cleaning or sorting in the lines and, then, 

20 harvesting, drying, packing. And then, they are 

21 ready to go to the market.

22 There is actually a program in seaweed 
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1 farming. You cannot be idle. Especially if you 

2 have a big farm of two hectares, a family of five 

3 to seven can practically farm two hectares, and 

4 that will give you a lot of income annually.

5 CHAIR FAVRE: Harold?

6 MEMBER AUSTIN: Okay. Not quite 

7 getting to my point, though, but I appreciate that 

8 additional information.

9 But, if we were to say, okay, we're no 

10 longer going to allow carrageenan in organic 

11 production, we would then take away the jobs, the 

12 ability for those --

13 MS. HURTADO: A lot of jobs.

14 MEMBER AUSTIN: If they could not farm 

15 carrageenan, what would they physically do for a 

16 living?

17 MS. HURTADO: Oh, especially in the 

18 southern Philippines where there are hundreds of 

19 islands and there are isolated islands, I think 

20 removing seaweed cultivation in those areas will 

21 dramatically change their lives.

22 CHAIR FAVRE: Final question, Jean.
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1 MEMBER RICHARDSON: Thank you for your 

2 excellent presentation.

3 When we look at the seaweed, the red 

4 seaweeds, and so on, growing there on the slide you 

5 showed us, are they growing as part of a marine 

6 ecosystem or in a monoculture?

7 MS. HURTADO: Oh, these are all 

8 monoculture because we haven't tried what is very 

9 popular in Canada and in Western Europe. It is 

10 monoculture, yes.

11 CHAIR FAVRE: Thank you very much.

12 MS. HURTADO: You're welcome.

13 CHAIR FAVRE: Next up is Urvashi 

14 Rangan, followed by James McKim.

15 DR. RANGAN: Good morning. My name is 

16 Urvashi Rangan. I'm the Executive Director for 

17 the Food Safety and Sustainability Center at

18 Consumer Reports. I'm a toxicologist and 

19 environmental health scientist.

20 For those of you who are new to us, we 

21 are an 80-year-old organization. Our parent 

22 company used to be Consumers Union. That is now 
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1 our policy arm. Our parent brand is Consumer 

2 Reports. We have about 8.5 million subscribers 

3 and more than 1 million activists.

4 We conduct label ratings. We draw 

5 comparisons among them. We run national survey 

6 polls, some of the largest next to the Census. And 

7 we have been documenting consumer attitudes and 

8 expectations on labels, including organic and 

9 natural, for the past several years.

10 The natural label, as many of you know, 

11 undermines the organic label. There is an open 

12 comment period right now, open until May 10th. We 

13 are proposing to either ban the natural term 

14 altogether or define it as organic plus no 

15 artificial ingredients. Any group in the room 

16 that wants to sign onto our letter can and reach 

17 out to Charlotte Vallaeys, my colleague.

18 Some of the areas that fall short of 

19 consumer expectations in organic are also the basis 

20 for why we rate organic as meaningful instead of 

21 highly meaningful compared to other labels and to 

22 the 100-percent organic label. That includes our 
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1 continued concern with the sunset of materials. 

2 We are concerned, again, with the vote change, that 

3 NOP has made it easier to maintain the use of 

4 non-organic ingredients, and the reason being is 

5 because consumers actually care about artificial 

6 ingredients.

7 Our 2015 December poll shows that 79 

8 percent of people don't actually really want 

9 artificial ingredients in their foods in general. 

10 Eighty-six percent think that there shouldn't be 

11 artificial ingredients or colors in foods labeled 

12 as organic.

13 In February we featured 25 products 

14 that we think are misleading when it comes to 

15 natural labeling, which you can also infer that 

16 would be misleading in terms of organic, that 

17 featured ingredients like xanthan gum, 

18 carrageenan, cellulose, and caramel color.

19 Carrageenan, as independent scientists 

20 and the bandwagon that others refer to in this room, 

21 we are concerned about the human, animal, and cell 

22 studies with gastrointestinal issues related to 
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1 carrageenan as well as the breakdown products, 

2 which can occur on the shelf or in the gut, that 

3 are classified as Class 2B carcinogens by the World 

4 Health Organization. Neither the World Health 

5 Organization or Consumer Reports is vested in 

6 carrageenan. We are concerned about it as 

7 independent scientists.

8 We think the loophole on antibiotic use 

9 in poultry also needs to be shut down and be 

10 consistent with livestock and poultry antibiotic 

11 use across the board.

12 And while we know you haven't proposed 

13 things for aquaculture, we thought we would bring 

14 our 2016 survey results to you. Ninety-three 

15 percent of people expect organic aquaculture 

16 standards to have 100-percent organic feed. 

17 Eighty-eight percent expect standards to prohibit 

18 antibiotics and other drugs, and 87 percent expect 

19 no colors or feed added to the fish. Seventy-three 

20 percent expect no open pens.

21 (Timer rings.)

22 Thank you.
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1 CHAIR FAVRE: Good job.

2 Any questions?

3 (No response.)

4 Thank you very much.

5 Oh, Harriet?

6 MEMBER BEHAR: You mentioned that 

7 carrageenan will break down on the shelf?

8 DR. RANGAN: It can.

9 MEMBER BEHAR: I thought that it broke 

10 down like in an acid environment. How --

11 DR. RANGAN: It is really not clear to 

12 us. The industry studies that were --

13 MEMBER BEHAR: Oh, yes. Do you have 

14 like citation that could help me find that?

15 DR. RANGAN: The industry studies that 

16 were presented several years ago showed breakdown 

17 products of carrageenan. We submitted detailed 

18 comments on that, Harriet.

19 MEMBER BEHAR: Okay.

20 DR. RANGAN: We can pull those out and 

21 give those to you.

22 We are concerned. There are many 
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1 products that break down both on the shelf or in 

2 the gut. Nitrosamine formation is one of those 

3 examples. Nitrates and nitrosamine formation can 

4 occur both on the shelf and in the gut, and there 

5 is also a susceptibility issue involved in that as 

6 well.

7 I think what is really particularly 

8 concerning about carrageenan is that it is not just 

9 reports of people with tummy aches. It is 

10 human -- it is actually quite a large number of 

11 human people who have reported problems. We need 

12 to understand that, and that is an important 

13 attribute scientifically.

14 But not only that, there are a whole 

15 slew of animal studies as well as cellular studies. 

16 As a toxicologist, you must put that prism together 

17 and look through that when you are determining 

18 whether it is safe or not.

19 And remember, this Board should know it 

20 is safe, not sort of guess that it might not be. 

21 The responsibility here is higher. Grass is not 

22 an adequate system for you to rely on to determine 
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1 safety. It just isn't. And FDA admits itself 

2 there's a number of problems. So, you have a 

3 bigger task to know it is safe.

4 But there are a number of studies out 

5 there that question its safety. Because of that, 

6 we don't think it is appropriate as an ingredient 

7 in organic.

8 MEMBER BEHAR: Okay. Thank you.

9 DR. RANGAN: Thank you.

10 CHAIR FAVRE: Thank you very much.

11 DR. RANGAN: Thanks.

12 CHAIR FAVRE: Next up is James McKim, 

13 followed by Linda Froelich on deck.

14 DR. McKIM: Good morning. My name is 

15 Jim McKim. I'm here to talk to you about the last 

16 four years of research that my laboratories have 

17 been conducting around the safety of carrageenan.

18 I am a Board-certified toxicologist, 

19 specializing in biochemical and molecular fields. 

20 And my expertise is in vitro toxicology and the 

21 extrapolation of cell-based data to human risk. I 

22 am also the Chief Science Officer for Iontox, a 
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1 contract research laboratory.

2 We're doing this work because of a 

3 series of studies that had been published by a 

4 single group, the University of Illinois. They 

5 have reported that carrageenan does cause 

6 inflammation and it causes insulin resistance.

7 These studies were done using human and 

8 intestinal liver cell lines, but the data was not 

9 consistent with animal feeding studies. 

10 Therefore, it is very important as a scientist to 

11 verify another laboratory's work.

12 To do that, we looked at the three 

13 proposed mechanisms of carrageenan adverse 

14 effects. In the intestine and liver, they have 

15 proposed that inflammation is caused by 

16 carrageenan binding to a specific receptor known 

17 as TLR4 or by inducing reactive oxygen species, and 

18 in the liver, that those pathways crosstalk and 

19 inhibit insulin signaling.

20 This is a complex diagram that shows 

21 those signaling pathways. You can see that there 

22 are some major components. Our philosophy was to 
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1 take them apart and look at each one.

2 First, you have carrageenan binding to 

3 TLR4. You see that in the upper left. You have 

4 ROS being produced, the reactive oxygen species. 

5 And then, those pathways inhibit insulin 

6 signaling.

7 One thing that has been forgotten is 

8 that carrageenan, to get to the liver, has to be 

9 absorbed across the intestine and, then, absorbed 

10 across the liver cells. So, we looked at each 

11 pathway. We found no absorption of carrageenan 

12 that was detectable in in vitro models, and there 

13 is nothing reported that we have found in the animal 

14 models.

15 Carrageenan does not bind to TLR4. It 

16 doesn't do it in vitro in any of our cell models. 

17 And therefore, we don't see any induction of 

18 inflammatory cytokines.

19 In addition, we showed no reactive 

20 oxygen species formed. If these pathways aren't 

21 active, then you can't inhibit insulin signaling 

22 because it is crosstalk that does it.
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1 In conclusion, carrageenan in our 

2 laboratory over the last four years is not 

3 absorbed, does not induce inflammation or inhibit 

4 insulin-signaling pathways. And as I said, after 

5 four years of research on multiple cell lines, none 

6 of the findings related to carrageenan, to 

7 inflammation or insulin signaling has been 

8 repeatable.

9 If carrageenan is as promiscuous as it 

10 is reported to be, then it should not be difficult 

11 to repeat the work, at least some of it, even in 

12 trend. We have not been able to repeat any of it.

13 Thank you. I would be happy to answer 

14 questions.

15 CHAIR FAVRE: Zea?

16 MEMBER SONNABEND: Thank you.

17 I'm going to ask two questions in one, 

18 because I might not get another chance. I noticed 

19 that in your written comments you submitted 

20 abstracts of the work that you have just talked 

21 about to repeat the experiments from the University 

22 of Chicago. And I realize that it was only 
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1 abstracts because it is in preparation for 

2 publication in a journal. And so, the whole 

3 article is not available.

4 But I am wondering if you could address 

5 two things. One is, is the research methodology 

6 that you used exactly the same as what they showed 

7 in their articles? And the second is just sort of 

8 a bigger concern, which is if, as you say, the 

9 carrageenan binds with protein and, therefore, 

10 won't cross the barrier out of the intestinal 

11 tract, wouldn't that reduce the protein content of 

12 the foods that contain carrageenan because you 

13 can't absorb the protein, either, as well as the 

14 carrageenan?

15 DR. McKIM: Well, I will address the 

16 first question regarding the scientific 

17 methodology and being exact or not exact. We 

18 started out by asking simple questions. So, to 

19 answer your question, we tried to use the same cell 

20 lines whenever possible. We tried to follow the 

21 basic methodology of exposure and preparation. We 

22 extended the dose ranges. So, we used some 
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1 concentrations higher; we used some concentrations 

2 lower than the dose that was reported by the Chicago 

3 group. In some instances, we used different cell 

4 lines because we wanted to see what other lines 

5 these would affect.

6 For the insulin resistance work, the 

7 question was the HepG2 cell. That is a human 

8 hepatoma cell line. We use the same cell line. We 

9 followed the same dose and protocol, which requires 

10 a time of dosing of carrageenan in the presence of 

11 protein followed by a shorter time with no protein 

12 present. In addition to that, we extended the 

13 studies by using no protein at all.

14 So, yes, we're trying as closely as we 

15 can to follow the protocol. In some cases we take 

16 a different approach. So, just like a 

17 mathematical equation, sometimes it is better to 

18 get the same answer from two different directions. 

19 That gives you more confidence that you are not just 

20 repeating the same thing incorrectly, but the wrong 

21 step has been taken.

22 For example, our first paper that was 
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1 published on TLR4 binding, we used a human 

2 embryonic kidney cell line that had been designed 

3 to be highly-sensitive to TLR4 binding. We wanted 

4 to make sure that, if carrageenan was going to bind, 

5 we would see it in this. Because if it is binding 

6 to TLR4, it should bind to TLR4 in any system. Why 

7 just one cell line? So, we used the HEK for that. 

8 That is different from the Chicago group. But, as 

9 closely as we could, yes, we followed their 

10 protocol.

11 Another thing we did differently is we 

12 actually characterized the carrageenan. It is a 

13 very expensive process to do carbohydrate 

14 chemistry. If you don't know what you're testing, 

15 as a toxicologist, how can you determine the 

16 result, what the result is due to. Is it a 

17 causative result or is it a correlative result?

18 Okay. So, for protein binding, the 

19 protein-binding question, if carrageenan binds to 

20 protein in the diet and it is digested, as the 

21 protein moves down the gut, it should be digested 

22 just like always, and the carrageenan would be 
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1 released and it is excreted in the feces.

2 CHAIR FAVRE: Harold?

3 MEMBER AUSTIN: We have seen a lot of 

4 written scientific information presented to us 

5 that really delves into -- we have seen studies that 

6 are in vitro; we have seen studies that are in vivo. 

7 Could you explain to us the value or the breakdown 

8 of the value in vitro versus the in vivo studies?

9 DR. McKIM: Sure.

10 MEMBER AUSTIN: And help us to 

11 understand what this is all about and the 

12 importance of it.

13 DR. McKIM: Sure. The easiest way to 

14 think about it is that in vitro models or cell 

15 systems outside the body are highly useful for 

16 understanding specific mechanisms by which a 

17 chemical might interact. Ideally, then, you 

18 should be able to test that hypothesis in an animal 

19 model to see if the anticipated pathways, in fact, 

20 manifest in the symptoms or in the adverse event 

21 that you would expect to see in the animal.

22 In some cases, we have had to go 
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1 backward. So, there is a plethora of animal data 

2 where they have done really rigorous feeding 

3 studies and shown no effect on the gut. And yet, 

4 we are still forced to go back and look at the cell 

5 models to understand the mechanistic data that is 

6 purported for carrageenan.

7 So, the in vitro data is very useful for 

8 understanding species differences, you know, human 

9 cells versus rodent cells. It is also very useful 

10 for specific mechanisms, but you have to have the 

11 in vivo data to correlate that to.

12 Oh, and the other point I just want to 

13 bring up is exposure. You can't do risk assessment 

14 without exposure. So, in vitro you put a known 

15 concentration directly on a cell. If you put that 

16 on a liver cell, it is highly unlikely that that 

17 is the concentration the liver is actually going 

18 to see. So, unless you know what the 

19 bioavailability -- bioavailability is the amount 

20 that actually is absorbed and gets into the 

21 body -- you can't do the correct assessment.

22 CHAIR FAVRE: Thank you very much for 
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1 your comments.

2 DR. McKIM: You're very welcome.

3 CHAIR FAVRE: Next up is Linda 

4 Froelich, and we have Marty Mesh on deck.

5 MS. FROELICH: Good morning. My name 

6 is Linda Froelich, and I am the Sustainability II 

7 Director for FMC. Thank you for this opportunity 

8 today to speak with you.

9 I am here today to talk with you about 

10 sustainability, specifically about our 

11 manufacturing facility where we make carrageenan, 

12 the people who work there, and about carrageenan. 

13 Sustainability is in our DNA and how we do our 

14 business.

15 Our manufacturing facility was 

16 established in 1937 and is located in Rockland, 

17 Maine, on the pristine coast of the Atlantic Ocean. 

18 We are the only carrageenan manufacturing facility 

19 in North America and the largest carrageenan 

20 facility in the world. We have 130 employees. 

21 Multiple generations of families have worked at our 

22 Rockland site over the years.
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1 We are a major contributor to the 

2 sustainability of the community through 

3 participation in first-responder drills, hosting 

4 safety fairs at the plant, and contributing to the 

5 needs of the local area.

6 We are environmental stewards for 

7 global and local communities. We support 

8 biodiversity and aquaculture through sound seaweed 

9 farming and harvesting practices. We adhere to 

10 the strictest environmental standards in our 

11 industry, protecting resources, customers, and 

12 consumers.

13 All of the seaweed we use is grown, 

14 harvested, and packaged naturally without the use 

15 of fertilizers, pesticides, preservatives, or 

16 other chemicals. There is no 

17 generically-modified seaweed.

18 We have a holistic approach to 

19 manufacturing. Ninety-nine percent of the 

20 byproducts from our carrageenan processing is zero 

21 waste. The two primary byproducts created are 

22 algae fiber and seaweed shakings.
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1 Algae fiber contains organic matter and 

2 is used by local farmers to improve soil health and 

3 reduce farm input costs. Farmers seek algae fiber 

4 because it is easy to spread, it is slow release, 

5 and provides micronutrients. It is a great 

6 benefit to all parties involved in this resource 

7 reuse program.

8 In 2015, algae fiber was used at more 

9 than 50 farms in Maine to improve over 1800 acres 

10 of farmland. Additionally, it has been shown to 

11 help naturally increase plant root development and 

12 promote crop growth.

13 After harvesting and drying, the 

14 seaweed contains salts and sand in various 

15 proportions. In the first stage of processing the 

16 seaweed, it is chopped and screened to remove the 

17 bulk of the salt and the sand. Some seaweed 

18 particles also pass through the screen. This dry 

19 mixture, called seaweed shakings, contains 

20 potassium and is verified by OMRI to be used in 

21 certified organic production as a crop fertilizer 

22 and soil amendment.
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1 In 2014, the Rockland plant converted 

2 all of our energy use from No. 6 fuel oil to 

3 compressed natural gas. This conversion has 

4 resulted in a 30-percent reduction in greenhouse 

5 gas emissions.

6 However, at the end of the day, we are 

7 not here to talk about numbers. We are here to talk 

8 about people, community, and how the production of 

9 carrageenan improves lives.

10 I invite you all to come to visit the 

11 Rockland plant and see for yourself. We would 

12 really love to have you there.

13 Again, thank you very much for your 

14 time. And I urge you to relist carrageenan for 

15 continued use in organic foods and beverages.

16 Thank you.

17 CHAIR FAVRE: Thank you very much.

18 Questions?

19 (No response.)

20 Thank you.

21 MS. FROELICH: You're welcome.

22 CHAIR FAVRE: Next up is Marty Mesh, 
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1 followed by Jane Parker on deck.

2 MR. MESH: Tell me when. Don't start 

3 the clock yet. Some of the people who finished 

4 early deferred the rest of their time to me.

5 (Laughter.)

6 My name is Marty Mesh. I'm the 

7 Executive Director of Florida Organic Growers; our 

8 certification program, Quality Certification 

9 Services.

10 I started growing organically in 1973. 

11 Because there are so many new faces on the Board, 

12 I thought I would give a bit of a personal 

13 introduction. I started organically in 1973, on 

14 a larger scale in 1976, and the nonprofit we started 

15 in 1987.

16 So, people have asked me where the baby 

17 is, and here's a couple of pictures that are going 

18 to come.

19 (Laughter.)

20 And then, I will tie her into my 

21 presentation in a minute.

22 My farming partner and I steadfastly 
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1 disagreed about the benefits of a National Organic 

2 Program. He was totally opposed to it. I was 

3 supportive of it. And I told him, "I'll make this 

4 different. USDA, it will work. You'll see." 

5 And the experiment still is ongoing, but I believe 

6 it has worked.

7 I was OCC Chair for many years during 

8 the 2001 period. The OCC is now called the ACC, 

9 the Accredited Certifiers Caucus. And that was 

10 certainly herding cats and dealing with a 

11 less-sophisticated National Organic Program.

12 I certainly want to thank Miles and the 

13 NOP staff. I think they are underappreciated and 

14 oftentimes on the receiving end of throwing rocks. 

15 And the Board, for all the work that you guys have 

16 done and will do, certainly.

17 The hydroponic moratorium seems like a 

18 good idea to me. It was really back when Michael 

19 Sly was the Chair of the Board in the nineties that 

20 the Board said, "Yes, hydroponic production 

21 organically, we see this as a possibility. We see 

22 it." You know, fishmeal, seaweed, kelp, yes, it 
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1 could be done.

2 Now, of course, there has been a later 

3 recommendation, too. So, I think in the meantime, 

4 while this issue is revisited again, the moratorium 

5 is a good idea. To put a moratorium now to stop 

6 hydroponic, which is, in my estimation, 

7 water-grown with no media at all, would be a useful 

8 exercise.

9 Utility patents are a problem. The 

10 checkoff program that we are trying to start 

11 strictly prohibits the use of utility patents on 

12 seeds, breeds, or equipment. And so, if we can get 

13 that thing done, maybe that would be a way that we 

14 could springboard more organic plant-breeding 

15 research without patents.

16 I want to touch on citrus growers, but 

17 I will do that last, and Zea will ask me, I'm sure, 

18 if we run out of time.

19 The Policy Manual, maybe delaying the 

20 vote would be an appropriate decision. I urge you 

21 near the conclusion to consider the facts. I mean, 

22 you hear scientists on both sides of the issue. It 
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1 is hard to know what's true, what's not true, but 

2 to consider things carefully and, of course, 

3 ethically, and know that whatever comes out the 

4 other end of the pipeline, there's folks like me 

5 that will support it. Because not everybody is 

6 going to be happy at whatever decision you make.

7 For Jesse, I look forward to working 

8 with you to grow organic agriculture in 

9 Mississippi, something we have been passionate 

10 about, and to having another --

11 (Timer rings.)

12 Can I just finish the sentence?

13 -- another ally in terms of if 

14 corporations come to petition non-organic okra 

15 saying that they can't get enough non-organic okra 

16 in the South. I fought that alone for many years. 

17 And now, I believe, indeed, I will have another ally 

18 on the Board, if that becomes an issue.

19 In conclusion, I see organic as the next 

20 generation.

21 And there's my baby, the 10-month-old 

22 now, feeding Alice Waters organic broccoli. And 
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1 so, I think you have to weigh carefully saving the 

2 planet for the next few generations, for many 

3 generations to come. Our responsibility is to 

4 grow organic agriculture.

5 Thanks.

6 Oh, citrus greening, I am sure there was 

7 a question that was going to come.

8 (Laughter.)

9 CHAIR FAVRE: Zea?

10 MEMBER SONNABEND: Marty, what was I 

11 supposed to ask you about?

12 (Laughter.)

13 MR. MESH: Citrus greening continues 

14 to be a devastating --

15 (Laughter.)

16 I'll just skip the question and go ahead 

17 and give the answer.

18 It is continuing to devastate organic 

19 citrus and conventional citrus in Florida. I 

20 think that the Board will see a petition coming from 

21 citrus growers. I don't know how you beg or plead, 

22 but to view that petition in a much more expedited 
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1 manner because the life of organic citrus and the 

2 citrus farmers will be hanging much more than 

3 somebody that sees the material for use in 

4 processing at a later date. So, I don't know if 

5 you can do that, but I think it would be a good idea.

6 MEMBER SONNABEND: Well, could you be 

7 sure to let us know the name of what is being 

8 petitioned, once you find that out?

9 MR. MESH: If it is filed. I would 

10 rather not at this point until it is filed.

11 MEMBER SONNABEND: Right. Okay. 

12 Thank you. We'll look for it.

13 MR. MESH: It just got approved for use 

14 on citrus, and I see that as a last-ditch effort 

15 to try to save citrus in this scenario.

16 MEMBER SONNABEND: Okay. Thanks.

17 MR. MESH: Anything else?

18 And welcome back, Harold.

19 Is that it?

20 CHAIR FAVRE: Harold?

21 MEMBER AUSTIN: Thanks, Marty.

22 Marty, you complimented all of us up 
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1 here. You supported the USDA in your comments to 

2 them, the NOP.

3 MR. MESH: I've had my disagreements 

4 with you.

5 MEMBER AUSTIN: One of the things I 

6 would like to say is thank you for your passion in 

7 behalf of organics in such a positive way.

8 CHAIR FAVRE: Thank you very much.

9 Next up is Jane Parker, followed by 

10 Suzanne McMillan.

11 Just, guys, we're running quite a bit 

12 behind. We're going to do these two speakers. 

13 Then we are going to take a five-minute break. Do 

14 your best, but we have got to make up some time.

15 MS. PARKER: Good morning. My name is 

16 Jane Parker from Botanical Food Company in 

17 Australia. Before, I came from Scotland. So, you 

18 can probably tell by the accent.

19 Today we wish to support the addition 

20 of sodium lactate to the National List. However, 

21 we believe it should not be limited to microbial 

22 control in meat and poultry processing.
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1 We are a certified organic processor of 

2 chilled, made-with-organic herb and spice paste, 

3 Gourmet Garden. We have eight growers, and 50 

4 percent of our business is through sales to the U.S.

5 Our pace meets the needs of consumers 

6 who do not have access to fresh herbs and spices, 

7 and we put particular emphasis on quality and food 

8 safety. Sodium lactate has been approved as an 

9 ingredient for over six years. Unlike, for 

10 example, sodium citrate, it is made from two 

11 ingredients on the National List.

12 Herbs and spices are used for their 

13 flavor and medicinal qualities and are 

14 characterized by their essential oils. It is 

15 difficult to maintain their integrity either as a 

16 fresh or processed product, particularly their 

17 antioxidant qualities. Also, because of their 

18 nature and where and how they are grown, they are 

19 at high risk of pathogen contamination.

20 As the Gourmet Garden herb and spice 

21 paste are not heat- or acid-treated, we use various 

22 hurdles to maintain product safety and integrity. 
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1 For example, growing the correct plant for the 

2 environment, harvesting within the correct season 

3 and at the correct time of day, chilling to the 

4 correct temperature, washing, sanitizing, et 

5 cetera.

6 But we use one more, sodium lactate. 

7 As a single product, it is used to control and 

8 maintain pH. The natural pH within the raw herbs 

9 and spices vary by day, by drawer, et cetera. And 

10 for safety and integrity, product pH must remain 

11 within a critical range. At high pH microbial 

12 growth can pose food safety and quality issues. At 

13 low pH, certain plant compounds such as chlorophyll 

14 become unstable, resulting in product 

15 degeneration.

16 As a natural microbial, the lactate 

17 acid portion is known for its effectiveness in the 

18 controlling the growth of bacteria such as 

19 Listeria, E. coli, and Salmonella.

20 We have made many attempts to replace 

21 sodium lactate with other ingredients, as it is 

22 still not on the National List, such as sodium 
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1 citrate, but it is hard. We have found that there 

2 is no other single ingredient or even combination 

3 of ingredients that can take the place of sodium 

4 lactate without an increased food safety risk and 

5 the loss of flavor and nutritional integrity.

6 We believe that putting sodium lactate 

7 on the National List as a natural microbial and pH 

8 regulator will continue to give food processors a 

9 critical food safety tool. We also believe, as 

10 shown by our current use, that sodium lactate has 

11 a wider range of application than the meat and 

12 poultry industries, and sincerely request that 

13 this be considered.

14 Thank you.

15 CHAIR FAVRE: Thank you.

16 Jean?

17 MEMBER RICHARDSON: Just a quick 

18 question. Our proposal deals with sodium and 

19 potassium lactate. Is potassium lactate of any 

20 use in the same kind of things that you're --

21 MS. PARKER: We actually, apparently, 

22 don't use potassium lactate, but don't really see 
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1 it as an issue. The reason that we don't use it 

2 is that we use hydrogen salt and the sodium lactate 

3 as part of the preservation. So, we use the salt; 

4 whereas, potassium hasn't got that salt benefit, 

5 I think.

6 CHAIR FAVRE: Thank you very much.

7 MS. PARKER: Thank you.

8 CHAIR FAVRE: Our final speaker, our 

9 commenter before the break will be Suzanne 

10 McMillan. And then, we will take a very short 

11 break.

12 MS. McMILLAN: Hi. Thank you. I am 

13 Suzanne McMillan, Content Director for the Farm 

14 Animal Welfare Program at the ASPCA, which is the 

15 American Society for the Prevention of Cruelty to 

16 Animals. We are a national organization with over 

17 2.5 million supporters around the country. So, on 

18 their behalf, I would like to thank you for the 

19 opportunity to provide comments today.

20 Specifically, we would like to support 

21 the Livestock Subcommittee's proposal to reduce 

22 the withholding period for the anesthetics 
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1 lidocaine and procaine. Whether farm animals are 

2 raised organically or otherwise, pen control is 

3 central to their welfare. Farmers need to be able 

4 to provide animals with anesthetics and analgesics 

5 as needed, no matter the point in the animal's 

6 production cycle.

7 If an animal's marketability drops due 

8 to a treatment protocol, there is potential to 

9 inadvertently create a disincentive to treat. The 

10 Livestock Subcommittee's proposal notes that an 

11 extended withholding period for anesthetics can 

12 have this effect by causing animals to either 

13 receive delayed treatment or none at all.

14 The Subcommittee also states in its 

15 proposal that it has found no scientific reason to 

16 extent the withholding periods beyond the number 

17 of days proposed.

18 Given these considerations, the ASPCA 

19 supports the proposal to reduce the withholding 

20 periods for procaine and lidocaine to the number 

21 of days suggested.

22 We would also like to note a larger 
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1 context around this conversation. It is generally 

2 uncommon for farm animals to receive pain control, 

3 be it anesthetics or analgesics, for physical 

4 alterations. But a broad array of alterations are 

5 commonly performed to compensate for certain 

6 conditions and stressors that can arise in 

7 commercial farming which lead to undesirable 

8 behaviors. It is not uncommon to remove portions 

9 of animals peaks, toes, tails, and other body parts 

10 to mitigate these behaviors. We encourage input, 

11 such as adequate space, enrichment, proper diet, 

12 and healthy genetics, among others, to reduce the 

13 need for some of these alterations.

14 This bigger holistic picture is one 

15 reason the ASPCA is so pleased to see the USDA's 

16 proposed rule on organic animal welfare. It 

17 addresses some of these inputs I just mentioned. 

18 We thank the NOSB for making many of the 

19 recommendations over the years that formed the 

20 basis of the proposed rule.

21 Thank you.

22 CHAIR FAVRE: Thank you very much.
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1 Questions?

2 (No response.)

3 Thank you.

4 All right. We are going to take a 

5 break. By my count, we are about 30 minutes behind 

6 schedule. So, I'm going to say a five-minute, 

7 recognizing that the line to the bathroom will 

8 probably take longer than that. But, everybody, 

9 make your efforts to get back here as quickly as 

10 possible.

11 (Whereupon, the foregoing matter went off the record at 10:27 a.m. and 

12 went back on the record at 10:42 a.m.)

13 CHAIR FAVRE: As we get started back this afternoon or this morning, 

14 late morning, I am going to ask one of our Board members, Scott Rice, to read us a little 

15 passage to keep us focused on the big picture.

16 Scott?

17 MEMBER RICE: Thanks, Jean. Or Tracy. Excuse me.

18 (Laughter.)

19 CHAIR FAVRE: That was a Freudian slip.

20 (Laughter.)

21 MEMBER RICE: I was going to reference--

22 MEMBER RICHARDSON: Wasn't it a compliment, though. Thank 
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1 you.

2 CHAIR FAVRE: Of course.

3 MEMBER RICE: I was going to reference Jean's poem from yesterday 

4 and just note that it is the 20th anniversary of National Poetry Month. I don't know if you 

5 all knew that. And so, it was fitting that Jean started us off with a poem, and I had that in 

6 mind as well. And I also had in mind a Robert Frost poem. So, I am going to stick with 

7 that because it is one that speaks to the time of year when all of us are thinking about weeds 

8 getting ahead of us and things needing tending back home.

9 "Putting in the Seed".

10 "You come to fetch me from my work 

11 tonight when supper's on the table, and we'll see 

12 if I can leave off burying the white soft petals 

13 fallen from the apple tree. (Soft petals, yes, but 

14 not so barren quite, mingled with these, smooth 

15 bean and wrinkled pea.) And go along with you ere 

16 you lose sight of what you came for and become like 

17 me, slave to a springtime passion for the earth. 

18 How Love burns through the Putting in the Seed on 

19 through the watching for that early birth when, 

20 just as the soil tarnishes with weed, the sturdy 

21 seedling with arched body comes shouldering its way 

22 and shedding the earth crumbs."
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1 Thanks.

2 CHAIR FAVRE: Thank you, Scott. 

3 Hopefully, that will help get us focused and remind 

4 us of what we are here about.

5 Our first speaker/commenter is Annie 

6 Rouse, and we have Lydia Henshaw on deck.

7 MS. ROUSE: Thank you.

8 Good morning. My name is Annie Rouse, 

9 and I'm here today to advise that the USDA approve 

10 organic certification for industrial hemp, to 

11 improve research data availability, and support a 

12 nascent domestic industry.

13 In 2013, before the 2014 farm bill even 

14 passed, the U.S. Department of State used federal 

15 funding to grant me a U.S. Fulbright scholarship 

16 to study the environmental life cycle of hemp in 

17 Canada.

18 After my Fulbright experience, I 

19 started the Kentucky Hemp Research Foundation. 

20 Part of our research is conducting economic 

21 assessments on hemp, but the instructions on the 

22 USDA's refusal to allow organic hemp 
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1 certifications is hindering market research and is 

2 in direct violation of the 2016 omnibus bill, which 

3 states that none of the funds made available by this 

4 Act or any other Act may be used in contravention 

5 of Section 7606 of the Agricultural Act or to 

6 prohibit the transportation, processing, sale, or

7 use of industrial hemp that is grown or cultivated 

8 in accordance.

9 Because of the USDA's stance, major 

10 U.S.-based organic hemp companies cannot buy 

11 organic hemp grown on organic U.S. soil. So, it 

12 is impossible to research the price premium or the 

13 economic impact. But the farming industry wants 

14 it and needs it.

15 The Foundation has a goal organic 

16 program which helps to educate farmers and 

17 processors on how to transition to organic with 

18 hemp. Given that hemp is already non-GMO, has a 

19 growing market, and serves as a great rotational 

20 crop, we have found that farmers are actually 

21 excited to transition to organics with hemp. And 

22 this is in Kentucky, where conventional 
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1 agriculture is king. But, if they can't get 

2 organic certification, they can't receive a price 

3 premium on the organic industrial hemp, then they 

4 do not think it is worth it to transition.

5 Finally, the Letter of Determination 

6 issued on February 16th references USDA organic 

7 regulations' general requirements for 

8 accreditation. The last subsection in this states 

9 that "No certifying agent shall exclude from 

10 participation in or deny the benefits of the 

11 National Organic Program to any person due to 

12 discrimination because of national origin."

13 However, this decision is directly in 

14 violation of the requirements because it is causing 

15 certifying agents to discriminate against U.S. 

16 organic hemp growers and processors based on their 

17 U.S. national origin. Canadian organic hemp is 

18 considered USDA organic. So, why can't U.S. hemp?

19 The current stance is favoring 

20 international imports and squashing a fledgling 

21 domestic industry, a domestic organic market that 

22 is worth over $15 million and growing which could 
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1 be supporting a local farming economy, fostering 

2 sustainable agriculture, and building a domestic 

3 industry.

4 The federal government supported my 

5 research before hemp was even legal for research 

6 purposes. Now that it is legal for research, it 

7 is time the USDA support the local organic hemp

8 industry by allowing organic certification, so 

9 that we may conduct robust economic research on 

10 organic hemp and because adding a new organic 

11 rotational crop will grow the organic industry and 

12 the U.S. farming economy.

13 (Timer rings.)

14 Thank you.

15 CHAIR FAVRE: Thank you very much.

16 Yes, Miles?

17 MR. McEVOY: Yes, in terms of the 

18 industrial hemp issue, I would just read something 

19 from our memo from February. Section 7606 of the 

20 Agricultural Act of 2014. "Authorized 

21 institutions of higher education and state 

22 departments of agriculture to establish industrial 
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1 hemp research pilot programs in states where the 

2 production of industrial hemp is legal and subject 

3 to certain other conditions."

4 The problem is that our understanding 

5 is that there is some conflict with that provision 

6 and some other federal statutes. So, USDA has been 

7 working with the Department of Justice to clarify 

8 the provisions under federal law for growing 

9 industrial hemp. That guidance on producing 

10 industrial hemp in the U.S. is very close to being 

11 published. We thought it would come out this 

12 month. But, once that is published, then further 

13 guidance will be provided to certifiers in terms 

14 of how they could go about certifying hemp. Until 

15 then, since there has not been clarification under 

16 the 2014 farm bill, certifiers cannot certify 

17 industrial hemp.

18 CHAIR FAVRE: Dan?

19 MEMBER SEITZ: It has been a while 

20 since I have read about industrial hemp, but my 

21 memory is that it is an amazingly versatile crop, 

22 one that was revered by our Founding Fathers.
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1 I am just wondering, what, again, is the 

2 reason why it was outlawed? I understand there was 

3 a connection with marijuana. But if you could just 

4 clarify, so that we understand what the connection 

5 between hemp and marijuana is?

6 MS. ROUSE: Sure. So, industrial hemp 

7 and marijuana are in the same plant family as, 

8 actually, is beer hops. And marijuana and 

9 industrial hemp are different varieties of the 

10 Cannabis sativa L. plant species.

11 Marijuana is a high THC, which is 

12 tetrahydrocannabinol, the psychoactive ingredient 

13 found in marijuana, and it usually is between 5 to 

14 25 percent THC.

15 Industrial hemp, by definition, is less 

16 than 1 percent and, by regulation, is less than .3 

17 percent. This is in Canada and the U.S. and all 

18 across the world.

19 Back in 1937, industrial hemp was 

20 pushed under marijuana as the same plant and has 

21 been regulated under the Marijuana Tax Act of 1937. 

22 So, since then, it has been subjected to the same 
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1 regulations as marijuana, even though the 

2 psychoactive ingredient that is found in both of 

3 them is by far less than what is found in marijuana.

4 Industrial hemp is used as a fibrous 

5 crop and as an oil in food, health food. So, you 

6 could use it in buildings, automobiles. It is a 

7 health food with high amino acids, and it has a 

8 near-perfect omega-3-to-omega-6 ratio. The oils 

9 can be used in cosmetics as well as ethanol, and 

10 you can also consume it, and you would not receive 

11 the psychoactive effects because that TCH is 

12 actually found in the flowers, not within the fiber 

13 or within the grain.

14 Thank you.

15 CHAIR FAVRE: Thank you very much.

16 Next up is Lydia Henshaw, and we have 

17 got Jaydee Hanson on deck.

18 MS. HENSHAW: Hello. My name is Lydia 

19 Henshaw, and I am representing Sow Organic, a 

20 digital platform for the organic supply chain.

21 Thank you, Distinguished Members of the 

22 Board, for the opportunity to testify today.
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1 This morning I am proposing that the 

2 NOSB take up discussion regarding incentive 

3 structures for organic operators, certifiers, and 

4 inspectors to adopt digital solutions for organic 

5 certification, administration, and production.

6 By digital solutions, I am referring 

7 directly to platforms, systems, and tools that 

8 improve productivity and workflow related to 

9 compliance with organic production and 

10 transparency, such as technologies to streamline 

11 organic certification management and modernize 

12 legacy systems from a paper-based existence.

13 This proposed request supports the 

14 Paperwork Reduction Act of 1980, and it is also 

15 similar in structure to the Organic Cost-Share 

16 Program introduced in recent years. In 2012, the 

17 Organic Cost-Share Program provided 10,000 

18 reimbursements, totaling over $6 million, to new 

19 and existing operators. A similar reimbursement 

20 structure that encourages adoption of digital 

21 solutions across the supply chain could yield an 

22 exponential increase in productivity and 
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1 profitability of organic operations. This can 

2 ensure a strong, scalable supply chain poised to 

3 meet increasing output demands in future years.

4 People, process, and platforms are 

5 fundamental components of an operating 

6 environment, and they are key to a sustainable 

7 industry. In a highly-transactional industry 

8 like organic, it is important to integrate both 

9 human and digital dimensions for agility and for 

10 longevity.

11 Enabling technology that supports 

12 administration and oversight will yield more 

13 capacity for regulation to focus on nuanced areas 

14 of organic production and administration; 

15 therefore, relieving burdens of compliance and 

16 increasing integrity for the long-term.

17 Sustainability for organic operations 

18 can be enabled through an intensified focus on 

19 technology. Industry incentives can encourage 

20 research and development of new engineering 

21 approaches using hardware and software to solve 

22 challenges in production and management. Greater 
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1 efficiency in operations enables more capacity for 

2 value creation in organic production.

3 As an industry, we should aim to make 

4 it increasingly easier for organic operators, 

5 certifiers, and inspectors to adopt technology 

6 that can reallocate manpower into more 

7 value-creation activities, such as providing 

8 breakthroughs in the science of organic 

9 production. Therefore, the introduction of 

10 incentive structures for adoption of digital 

11 solutions is proposed in order to yield such 

12 benefits.

13 Thank you for the time, the 

14 consideration, and the opportunity to propose a 

15 solution for a more efficient, transparent, and 

16 agile organic industry of the future.

17 CHAIR FAVRE: Thank you very much.

18 Any questions?

19 (No response.)

20 All right. Thank you.

21 MS. HENSHAW: Thank you.

22 CHAIR FAVRE: Next up is Jaydee Hanson, 
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1 and then, we have got Jennifer Lonergan on deck.

2 MR. HANSON: Good morning. I'm Jaydee 

3 Hanson, Senior Policy Analyst at the Center for 

4 Food Safety and a member of our science team. The 

5 Center for Food Safety has submitted extensive 

6 comments on past discussion documents on excluded 

7 methods. In our written comments for this cycle, 

8 we have provided additional feedback and 

9 scientific expertise on excluded methods.

10 CFS urges the Board, though, to refer 

11 this proposal back to Subcommittee and to consult 

12 with independent scientists to prepare a new 

13 proposal that clarifies and refines the 

14 definitions, principles, criteria, and 

15 terminology.

16 The definition and understanding of 

17 excluded methods must incorporate the full range 

18 of new plant, animal, microbe, genetic engineering 

19 methods and techniques. That said, the current 

20 NOP definition of excluded methods related to 

21 modern biotechnology should be seen as 

22 encompassing a broad swath of the significant new 
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1 and emerging technologies. That definition will 

2 continue to be important as new technologies 

3 emerge.

4 The proposed guidance will serve as an 

5 additional benchmark when questions or concerns 

6 arise regarding a new technology, but cannot 

7 provide an exhaustive list of all future excluded 

8 methods. We understand the organizational 

9 methods of compiling the terminology chart on new 

10 and existing techniques, but it must be made clear 

11 that the chart does not and cannot encompass the 

12 full range of genetic engineering methods that 

13 would be considered excluded from organic 

14 production and processing.

15 We reiterate from our previous comments 

16 that all of the various new techniques would fall 

17 under the umbrella of genetic engineering that are 

18 examples of excluded methods; i.e., genetic 

19 engineering. However, there are other methods and 

20 techniques that fall outside the umbrella of 

21 genetic engineering that might also be considered 

22 objectionable to the organic community and 
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1 incompatible with the underlying philosophy and, 

2 therefore, must also be considered excluded 

3 methods.

4 This is captured in the existing 

5 definition, and I quote, "a variety of methods used 

6 to genetically modify organisms or influence their 

7 growth and development by means that are not 

8 possible under natural conditions or processes and 

9 are not considered compatible with organic 

10 production". End of quote.

11 From this definition, any method that 

12 influences the growth and development of organisms 

13 by means not possible under natural conditions or 

14 processes should not be considered compatible with 

15 organic and would fall under the definition of 

16 excluded methods.

17 (Timer rings.)

18 I will point you to our rather 

19 extensive, marked-up comments. I think we have 10 

20 pages of comments just on excluded methods that we 

21 have provided you in writing.

22 CHAIR FAVRE: Thank you very much.
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1 Any questions?

2 Zea?

3 MEMBER SONNABEND: Thank you, and 

4 thank you for your ongoing participation in this 

5 effort, which I am the lead person on.

6 I have two questions.

7 MR. HANSON: Sure.

8 MEMBER SONNABEND: The first one is 

9 pretty simple. You do recommend that we send the 

10 criteria, in particular, principles and criteria 

11 back to engage with independent scientists. If we 

12 were to do that, would you have some independent 

13 scientists you could recommend for that 

14 consultation?

15 MR. HANSON: Yes, we would be happy to 

16 do that.

17 MEMBER SONNABEND: Okay. And then, 

18 the second question is, your organization didn't 

19 mention this, but others did: that it would be 

20 helpful if we also defined traditional plant 

21 breeding as one of the definitions, which is 

22 referred to in the excluded methods definition. 
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1 Is that something you see value in?

2 MR. HANSON: I do see it valuable. In 

3 our written comments, we identified some things 

4 that are being used in traditional breeding methods 

5 that might in another context become an excluded 

6 method.

7 So, in our discussion on transposons, 

8 for example, and in discussions of things like 

9 cisgenics, you will have to unpack that definition 

10 of traditional breeding some more.

11 CHAIR FAVRE: Questions?

12 (No response.)

13 Thank you very much.

14 MR. HANSON: Thank you very much for 

15 your work and your time. As hard as it is to be 

16 in the audience sitting listening to all of this, 

17 you have to sit and be attentive to all of it. So, 

18 thank you very much.

19 CHAIR FAVRE: Thank you for that.

20 Next up is Jennifer Lonergan, followed 

21 by Britt Lundgren.

22 MS. LONERGAN: Okay. Good morning. 
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1 My name is Jen Lonergan. I work at the Humane 

2 Society of the United States as a Regulatory 

3 Affairs Specialist.

4 I, first, want to say thank you for the 

5 opportunity to provide comments today. And more 

6 importantly, I want to thank the Board for your 

7 years of recommendations regarding animal welfare 

8 that were the basis for the recently-released 

9 proposed rule that we strongly support and we are 

10 really excited to see. And I am sure you all were 

11 just as excited, if not more so. So, thank you so 

12 much for all of your work.

13 I am here today to bring your attention 

14 to three key issues that the agency would love to 

15 see this Board address or continue to address in 

16 more detail in the future. Those issues are pain 

17 relief, calf hutches, and care for broiler 

18 chickens.

19 So, the first issue is pain relief for 

20 routine physical alterations such as castration 

21 and dehorning. We thank the NOSB for your work on 

22 this important issue in the past, and we support 
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1 the Livestock Subcommittee's proposal to shorten 

2 the withholding period for two anesthetics, 

3 lidocaine and procaine. We hope that this will 

4 encourage their greater use.

5 USDA's newly-proposed animal welfare 

6 rule takes important steps on this topic, but it 

7 is not quite as strong as NOSB's recommendations. 

8 It is a little vague, and it may still allow 

9 substantial animal suffering by failing to address 

10 some of the most painful physical alterations. 

11 So, we will be submitting comments on the proposed 

12 rule in hopes of strengthening this section of that 

13 rule and making it more consistent with NOSB's 

14 recommendation.

15 The second concern is calf hutches used 

16 in dairy production. Young calves are energetic, 

17 playful, and social animals. Yet, on many 

18 operations they are confined individually in calf 

19 hutches with very little space.

20 Disease prevention is obviously 

21 important, but interaction and social contact 

22 could be better accommodated in dairy-rearing 
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1 systems. Some producers are doing really well 

2 rearing calves in small groups, pair housing or 

3 collective hutches. And the research supports 

4 that these housing systems can be viable 

5 alternatives to individual hutches, pens, or 

6 tethering. So, we hope that the Board will 

7 consider recommending further integration of these 

8 systems in the organic program.

9 We're also concerned about the use of 

10 commercial broiler chicken genetics. These birds 

11 are bred for rapid growth, and because they 

12 accumulate excessive weight on an immature 

13 skeletal system, they are prone to debilitating leg 

14 disorders, metabolic disease, and poor immunity. 

15 Studies have been consistently showing that about 

16 30 percent of broiler chickens suffer from gait 

17 abnormalities that are significant enough to cause 

18 pain with locomotion. So, we hope that the organic 

19 program will require the use of more robust broiler 

20 chicken strains that are healthier and have better 

21 leg strength. Every major genetics company now 

22 has a slower-growing broiler chicken line, and 
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1 heritage birds don't tend to suffer these effects 

2 to the same extent. So, we see these hardier lines 

3 as the solution.

4 (Timer rings.)

5 Thank you so much for considering our 

6 comments.

7 CHAIR FAVRE: Thank you very much.

8 Questions?

9 (No response.)

10 Thank you.

11 MS. LONERGAN: Thanks.

12 CHAIR FAVRE: Next up is Britt 

13 Lundgren, followed by Bob McGee.

14 MS. LUNDGREN: Hi, everybody. Thank 

15 you for this opportunity to comment.

16 My name is Britt Lundgren. I'm the 

17 Director of Organic and Sustainable Agriculture at 

18 Stonyfield. I have submitted detailed written 

19 comments, and I am going to focus today on nutrient 

20 vitamins and minerals.

21 Stonyfield supports the continued 

22 allowance of vitamins and minerals in certified 
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1 organic foods, and we agree with the need to update 

2 and clarify the listing.

3 Stonyfield supplements many of our 

4 yogurts with vitamin D. Although this is not 

5 required by law, we do it because of the substantial 

6 health benefits that it provides. The 2015 

7 Dietary Guidelines say that vitamin D is an 

8 underconsumed nutrient of public health concern 

9 and note that yogurt is commonly fortified with 

10 vitamin D and, thus, a potential dietary source of 

11 this underconsumed nutrient.

12 Stonyfield supports a version of option 

13 2 that was presented by the Handling Subcommittee, 

14 and we suggest the listing should read, "vitamins 

15 and minerals as identified as essential in 21 CFR 

16 101.9 or as required for infant formula by 21 CFR 

17 Section 107.100 or 107.10".

18 This language ties the annotation to a 

19 clear listing of what vitamins and minerals are 

20 allowed and makes it clear that all other nutrients 

21 need to be petitioned and evaluated separately. 

22 This will make the requirements clearer, 
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1 transparent, and easily understood by all.

2 We are concerned that the Handling 

3 Subcommittee's first option would force us to 

4 choose between providing consumers with a 

5 certified organic product or providing them with 

6 a product that meets their nutritional 

7 expectations for yogurt, most of which are 

8 fortified with vitamin D.

9 We are unaware of a nonsynthetic option 

10 for vitamin D and we would not be willing to switch 

11 our products to the "made with" category in order 

12 to continue using vitamin D in our products. The 

13 traditional distinction between the 95-percent 

14 organic category and the "made with organic" 

15 category is based solely on the volume of 

16 ingredients, not on which ingredients are allowed 

17 in the remaining 5 or 30 percent of the product. 

18 If we had to move to a "made with organic" 

19 designation for our products, the implication to 

20 many consumers might be less than 95 percent of the 

21 ingredients in our product are organic. And this 

22 would be confusing for many and a real disservice 
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1 to the farmers who supply the organic ingredients 

2 that in reality make up over 95 percent of our 

3 products.

4 The NOSB has already done good work to 

5 address the need to refine the listing for vitamins 

6 and minerals in 2011. We urge USDA to complete the 

7 proposed rule that was issued based on these 

8 recommendations in 2012. NOSB does not 

9 necessarily need to issue a new recommendation on 

10 the annotation, but should use this opportunity to 

11 reinforce the message to USDA that their work on 

12 this topic needs to be completed. We hope that 

13 USDA NOP will take into account the additional 

14 comment from NOSB and move forward with completing 

15 the 2012 proposed rule.

16 In conclusion, we appreciate the work 

17 of NOSB on this topic and we are grateful for this 

18 opportunity to comment.

19 (Timer rings.)

20 I'm happy to answer questions.

21 CHAIR FAVRE: Zea?

22 MEMBER SONNABEND: Hi, Britt. Sorry 
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1 to do this to you, but does Stonyfield use 

2 carrageenan in any of your products?

3 (Laughter.)

4 MS. LUNDGREN: I knew somebody was 

5 going to do that. We have just completed phasing 

6 it out of all of our products.

7 MEMBER SONNABEND: And what 

8 alternatives have you used?

9 MS. LUNDGREN: Gellan gum or 

10 discontinuing in some cases.

11 CHAIR FAVRE: Tom?

12 VICE CHAIR CHAPMAN: Can you speak a 

13 bit more to the discontinuing? Are there quality 

14 differences you have seen in the products 

15 reformulated?

16 MS. LUNDGREN: Well, I don't think we 

17 would have reformulated and kept something on the

18 shelf if we felt quality was going to suffer 

19 significantly. So, my understanding is that R&D 

20 was able to find a satisfactory replacement. But 

21 there were a couple of cases where we couldn't find 

22 a satisfactory replacement in particular flavors. 
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1 And so, we chose to discontinue those flavors.

2 VICE CHAIR CHAPMAN: Is it particular 

3 flavors of a product or is it like entire product 

4 lines?

5 MS. LUNDGREN: It is just particular 

6 flavors. So, one example is that we had some 

7 yogurt with caramel on the bottom, and the 

8 carrageenan was important for the -- I'm not the 

9 R&D person and I didn't really prepare to answer 

10 all these questions. So, it is important for 

11 something in that caramel, and we just couldn't 

12 find a substitute that worked the same way.

13 VICE CHAIR CHAPMAN: Thank you.

14 CHAIR FAVRE: Thank you very much.

15 Next up is Bob McGee, with Albert Straus 

16 on deck.

17 MR. McGEE: Good morning. My name is 

18 Bob McGee, and I am the President of Straus Family 

19 Creamery.

20 Straus Family Creamery was the first 

21 creamery in the U.S. to be verified by the Non-GMO 

22 Project. Today we continue to have every load of 
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1 feed tested for the presence of GMOs.

2 I'm here representing eight organic 

3 dairy farming families and their employees, plus 

4 the 140 employees of Straus Family Creamery and 

5 their families. Their livelihoods are very 

6 dependent upon the actions and decisions of the 

7 Board and the program.

8 I want to thank Zea and the Materials 

9 Subcommittee for the work on the excluded methods 

10 terminology proposal. In combination with the now 

11 three discussion documents, the proposal helps put 

12 a framework around the new GE technologies in a way 

13 that a layperson can better understand.

14 Several people have spoken today and 

15 yesterday about how the proposal is not perfect yet 

16 and needs more work. I respect their knowledge and 

17 points of view. Genetic engineering in all its 

18 forms is a very complex topic, one that is difficult 

19 to understand and define.

20 However, there are two very simple 

21 facts that I think all of us can agree upon. The 

22 biotech companies that have developed and are 
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1 developing these new technologies are not going to 

2 wait to distribute their products until we meet in 

3 St. Louis nor until a new Administration is elected 

4 into office, makes it appointments, and comes up 

5 to the regulatory responsibilities.

6 Secondly, it seems to take quite a long 

7 period of time for the program to complete their 

8 work on proposals like this one. Do we really have 

9 one to two years, or maybe even longer, to wait? 

10 Even if the proposal isn't perfect, shouldn't we 

11 do something measured and well-considered? It is 

12 likely just the next step in a topic that will 

13 continue to challenge us and our farmers long into 

14 the future.

15 I encourage the entire Board to approve 

16 the proposal and for the program to act quickly on 

17 the recommended guidance.

18 Thank you.

19 CHAIR FAVRE: Questions?

20 Thank you.

21 Sorry. Tom?

22 VICE CHAIR CHAPMAN: Is it better to 
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1 ask you or Albert about carrageenan in dairy 

2 products?

3 MR. McGEE: You can ask either. We do 

4 not use any carrageenan. We use no thickeners in 

5 our yogurt. We occasionally use a little guar gum, 

6 but we don't use carrageenan at all.

7 VICE CHAIR CHAPMAN: And you haven't 

8 ever or recently since --

9 MR. McGEE: Have we ever used 

10 carrageenan (speaking to someone in the audience)?

11 PARTICIPANT: There is one product 

12 where we used it and we took it out.

13 VICE CHAIR CHAPMAN: And did you see a 

14 quality difference in that product?

15 MR. McGEE: No.

16 VICE CHAIR CHAPMAN: Thank you.

17 CHAIR FAVRE: Thank you very much.

18 Next up is Albert Straus, with Marni 

19 Karlin on deck.

20 MR. STRAUS: My name's Albert Straus. 

21 Thank you for letting me share my observations.

22 For the people that don't know me, I 
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1 started the first organic dairy and creamery west 

2 of the Mississippi River in the beginning of 1994. 

3 We now have nine family farms that supply us, and 

4 about 80 percent of the dairies in Marin and Sonoma 

5 County are certified organic.

6 One of the concerns I have is for 

7 succession in the next-generation farmers. Some 

8 of the dairies in our area don't meet the pasture 

9 requirements, and rather than looking at it from 

10 a compliance issue, looking at it from a 

11 certification issue: how do you get a tool that 

12 can be used by certifiers consistently across the 

13 board to evaluate whether a farm has enough acreage 

14 to meet the pasture standard?

15 So, I kind of came up with this tool. 

16 It is just a way to kind of look at, given optimistic 

17 amounts of pasture, dry matter, and meeting the 

18 minimum requirements in how many animals could be 

19 supported off of a piece of land -- anything like 

20 this would help consistently across the 

21 certifiers.

22 Then, the other thing I wanted to talk 
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1 about was there's a lot of issues around -- I have 

2 been farming all my life. What I notice is that 

3 a healthy animal doesn't need parasiticides. I 

4 mean, it is not something that is really -- well, 

5 I haven't used parasiticides in our cows for 30 

6 years and haven't had any problems. Calves, we had 

7 to use it once last year because we had a group of 

8 underperforming calves that got worms, which I 

9 haven't had in over a decade.

10 So, I think a healthy animal is 

11 something that is a concern of mine because, if you 

12 look at the grass-fed rules or grass-fed standards 

13 and labeling, which is the marketing label, not 

14 something that is going to help meet organic 

15 standards, meaning it is not going to help the 

16 viability of farmers. It is not going to help 

17 animal health or welfare. And so, I have huge 

18 concerns about having grass-fed as a term that is 

19 being used as a replacement or as an addition to 

20 organic certification. So, those are the kinds of 

21 comments I wanted to talk about.

22 The one other thing I wanted to talk 
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1 about was, as we all get older, the next generation 

2 and succession farming is a huge issue that we are 

3 dealing with, and I think we will have to deal with 

4 as an industry.

5 (Timer rings.)

6 Thank you.

7 CHAIR FAVRE: Questions?

8 Dan? Then, Emily?

9 MEMBER SEITZ: What do you do 

10 differently in terms of management that makes it 

11 possible for you to raise your herds without using 

12 parasiticides or virtually without using them?

13 MR. STRAUS: Balanced nutrition for 

14 the animals, best management practices on pasture, 

15 not overgrazing, not feeding feed on the ground 

16 like supplemental feeds, like hays, where you can 

17 get them eating off the ground and picking up worms. 

18 I mean, just kind from the calf all the way through, 

19 if you don't get a good start with a calf, get good 

20 colostrum, get good nutrition, you will have 

21 problems throughout their life.

22 CHAIR FAVRE: Emily?
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1 MEMBER OAKLEY: Do you, then, have

2 recommendations for how the emergency use should 

3 be defined?

4 MR. STRAUS: As far as parasiticides? 

5 I think there should not be any allowance in milking 

6 cows for parasiticides. If they have to use a 

7 parasiticide, they are no longer organic. And the 

8 second thing is, yes, that would negate the need 

9 to go from 90 days to two days. And so, I think 

10 that, yes, we should limit the use. I think we 

11 should not use it as a crutch.

12 I have had to retrain our veterinarians 

13 from the very beginning not to use conventional 

14 ideas and remedies. And it is something that is 

15 hard to do for most people, but over experience and 

16 over time you figure out ways of doing it as 

17 preventative rather than as a crutch and a 

18 solution.

19 CHAIR FAVRE: Harriet?

20 MEMBER BEHAR: Hi, Albert.

21 MR. STRAUS: Hi, Harriet.

22 MEMBER BEHAR: I have been to your farm 
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1 and it is a very unique ecosystem, quite beautiful, 

2 right there on the ocean. I think you can really 

3 get grass to grow there that other sections of the 

4 country, you know, we need more land per animal just 

5 because it is hard, unless you are irrigating, or 

6 whatever.

7 So, I just think, even the parasiticide 

8 issue, as we look at our standard is international, 

9 that not everyone would have somewhat of the ideal 

10 situation that you have in grazing and management.

11 MR. STRAUS: I wouldn't characterize 

12 our place as ideal. This is the first normal 

13 winter out of five years. We have had challenges 

14 of meeting the pasture standard for a few years. 

15 So, I think we have our challenges. We all have 

16 our challenges with our regions, but I think it 

17 comes back to management practices and prevention.

18 Yes, I agree that there's different 

19 scenarios and different things, but I think farmers 

20 can do their job in the areas that they farm. And 

21 some scenarios where they have too many animals on 

22 a small piece of land, look at all these different 
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1 criteria and say maybe we shouldn't be that big or 

2 we don't have enough land or the land can't sustain 

3 that.

4 So, I hope that answered your question.

5 CHAIR FAVRE: Thank you very much.

6 MR. STRAUS: Thank you.

7 CHAIR FAVRE: Next up is Marni Karlin, 

8 with Rhodes Yepsen on deck.

9 MS. KARLIN: Good morning. My name is 

10 Marni Karlin, and I'm Vice President of Government 

11 Affairs and General Counsel for the Organic Trade 

12 Association.

13 I'm here this morning to comment on the 

14 excluded methods terminology proposal. OTA 

15 continues to support a process-based approach to 

16 evaluating the use of excluded methods. We 

17 believe that the proposed definitions will be 

18 useful and, with some revisions, they will be 

19 proposal-ready.

20 The terminology chart and the criteria 

21 and principles, however, need a little more time 

22 and attention. OTA recommends taking the entire 
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1 proposal back to Subcommittee for further work, 

2 with the goal of releasing a final proposal prior 

3 to the fall 2016 NOSB meeting. We also recommend 

4 separating out the definitions from the rest of the 

5 proposal and moving the definitions section 

6 forward as an independent recommendation.

7 With respect to the definitions, OTA 

8 supports the proposed definition for modern 

9 biotechnology, but requests that NOSB reference 

10 Codex rather than the Cartagena Protocol since 

11 Codex is both recognized by the U.S. and referenced 

12 by the World Trade Organization. Adopting Codex 

13 definitions will help support both U.S. trade and 

14 interagency coordination.

15 In our written comments, we suggested 

16 revisions to the rest of the proposed definitions. 

17 And the one I want to focus on now is the definition 

18 of non-GMO. OTA thanks the Subcommittee for 

19 including this definition, as it is critical, given 

20 the final FDA guidance on voluntary GE labeling and 

21 the various state and federal initiatives in play 

22 regarding labeling of genetically-engineered 
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1 foods.

2 As Congress continues to work on the 

3 presence labeling legislation, it is critical that 

4 organic have a clear non-GMO definition in place. 

5 A clear definition of the terms "non-GMO" and 

6 "organic" is critical, as others are moving to 

7 define what may or must be labeled with a presence 

8 claim.

9 The term "non-GMO" is commonly used 

10 throughout the organic sector on labels and 

11 marketing materials to mean that the product was 

12 produced and handled without the use of excluded 

13 methods, as required by the organic regulations. 

14 Unlike the term "GMO-free," the term "non-GMO" does 

15 not necessarily mean a product is 100 percent of 

16 GMOs, but is a process-based claim. Securing a 

17 definition of non-GMO in NOP guidance will bolster 

18 the consistent use and interpretation of this 

19 frequently-used term, particularly in the face of 

20 others moving to define presence in other contexts.

21 The Subcommittee's proposed definition 

22 of non-GMO captures some, but not all, of the 
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1 comments we submitted in the fall of 2015. And we 

2 have suggested a revision in our written comments 

3 that we feel more precisely and accurately 

4 articulates the parameters around non-GMO.

5 With respect to the terminology chart, 

6 we continue to believe that such a chart would be 

7 very useful in guidance, and we believe both the 

8 chart and the principles and criteria need a little 

9 more work and more public input before they will 

10 be ready to move forward. If there is general 

11 agreement from public commenters that this section 

12 needs more work, OTA would be willing to form a task 

13 force and prepare comments in advance of the fall 

14 meeting.

15 In conclusion, I want to thank you all 

16 again for your work on this. We continue to be 

17 extremely supportive of moving recommendations 

18 forward to NOP that will not improve the practices 

19 used to keep GMOs out of organic seed, feed, and 

20 crops, but will also clarify the standards and 

21 terminology.

22 (Timer rings.)
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1 Thank you.

2 CHAIR FAVRE: Questions?

3 (No response.)

4 Thank you very much.

5 MS. KARLIN: Thank you.

6 CHAIR FAVRE: Next up is Rhodes Yepsen, 

7 followed by Peggy Miars on deck.

8 MR. YEPSEN: Hi. My name is Rhodes 

9 Yepsen. I'm the Executive Director of the 

10 Biodegradable Products Institute. We are a 

11 nonprofit that promotes the production, use, and 

12 appropriate end of lives for biodegradable 

13 materials.

14 I would like to address the NOP Policy 

15 Memo 15-1 which states that biodegradable mulch 

16 film must be 100-percent bio-based. This misses 

17 the point of what was petitioned and approved. The 

18 key attribute is for that mulch film to completely 

19 and safely biodegrade in the soil. This 

20 functionality is entirely separate from bio-based 

21 content. I would request that you please stand by 

22 the original approval.
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1 And I would like to share my time slot 

2 with Drew and Joan Norman of One Straw Farm, so you 

3 can hear directly from farmers about their 

4 experience with soil biodegradable mulch film.

5 Thanks.

6 MR. D. NORMAN: Good morning. My name 

7 is Drew Norman, and I run One Straw Farm, which is 

8 an organic farm, but not a certified organic farm 

9 at this point.

10 We were probably one of the first farms 

11 certified in the State of Maryland in 1986. So, 

12 it is with sadness that I withdrew my application 

13 for certification in 2012 because of my desire to 

14 use a biodegradable mulch film.

15 I use these films because they 

16 eliminate the disposal problem that we have with 

17 polyethylene films. They enable me to get my cover 

18 crops in the ground more quickly in the fall. And 

19 I find they are actually probably cheaper to use 

20 in the long-run when you take into account disposal 

21 cost of polyethylene films.

22 Thank you.
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1 MS. J. NORMAN: I just want to say that 

2 we actually withdrew our application and were told 

3 that, when it was approved, that we would be able 

4 to reapply again. So, we found out that bio-based 

5 films were approved and, then, we applied 

6 immediately and, then, found out very shortly 

7 afterward for a second time we had to withdraw our 

8 application for certification. We would love to 

9 be certified organic once again. So, we really 

10 hope that this gets changed and adjusted. And 

11 then, we can reapply immediately for our 

12 certification once again.

13 Thank you very much.

14 CHAIR FAVRE: Questions?

15 Zea?

16 MEMBER SONNABEND: Thank you both for 

17 coming once again and not giving up on this, what 

18 has turned into quite an involved, laborious 

19 process.

20 When you first made the decision to give 

21 up your certification in order to use the product, 

22 did you ask questions about how much of the material 
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1 was bio-based and did you have a sense of what the 

2 components are of what you were putting down? Or 

3 did you only look at the question of it breaking 

4 down all the way?

5 MR. D. NORMAN: I did as much research 

6 that I could with the information that was 

7 available. I certainly know much more about it 

8 today than I did five years ago, and that's through 

9 this whole process that you all have gone through. 

10 I have been kept abreast of all the information that 

11 was gathered.

12 But it was not a decision taken lightly 

13 by us, by any means. And I recognized that it was 

14 a synthetic product and it potentially had 

15 consequences, but, for the most part, our decision 

16 was based on the fact that it was approved in other 

17 parts of the world. And then, that is really why 

18 we decided that we were going to use it, and then, 

19 for the rest of the reasons, quite frankly.

20 CHAIR FAVRE: Francis?

21 MEMBER THICKE: Well, what is your 

22 experience with it breaking down at the end of the 
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1 season? Visually, what do you see and the 

2 timeframe and what happens? Do you till it in?

3 MR. D. NORMAN: During the 

4 biologically-active part of the season, i.e., 

5 summer when it is warm and moist, it breaks down 

6 very quickly. So, within, say, two weeks of laying 

7 the mulch, if you go right to where you are having 

8 soil contact with it on both sides, you can't 

9 separate the mulch from the soil anymore. It looks 

10 like a decayed leaf at that point. So, once it's 

11 in the soil, it breaks down very quickly.

12 The reason it stays put is it sort of 

13 kind of sticks to the surface of the soil. So, 

14 while the edges have decayed already -- and we're 

15 talking in less than a month -- what part that I 

16 am growing through stays intact. So, if I use 

17 mulch in the spring and till it in the ground in 

18 August, by October the only pieces that I'm seeing 

19 are the pieces that aren't mixed in with the soil.

20 And, you know, I live in Maryland. So, 

21 we have a very biologically-active soil. It's 

22 warm. It's moist.
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1 CHAIR FAVRE: Harriet?

2 MEMBER BEHAR: Can you compare to me 

3 the difference in labor or why you have decided to 

4 not use a plastic mulch that is allowed that you 

5 have to remove?

6 MR. D. NORMAN: I figure it takes like 

7 four people several hours to completely remove 

8 polyethylene mulch from the field. And then, we 

9 have the expense of disposing of it, too.

10 You know, I am sure that is something 

11 that every organic farmer struggles with when he 

12 uses polyethylene mulch, is the fact that he is 

13 taking something and using it and, then, having to 

14 throw it away. It is not recyclable. It is too 

15 dirty.

16 MS. J. NORMAN: We still do use the 

17 polyethylene mulch in addition to the 

18 biodegradable one. We use both of them, which we 

19 do dispose of properly.

20 CHAIR FAVRE: Emily?

21 MEMBER OAKLEY: Do you have any 

22 concerns for growers in more dry and 
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1 less-biologically-active soil conditions, like a 

2 desert environment or even just a colder 

3 environment without such a long growing season?

4 MR. D. NORMAN: Well, like if I use it 

5 late in the fall, it does not degrade over the 

6 winter at all, even if it is worked into the soil. 

7 I mean, our soils are frozen most of the wintertime. 

8 So, it sits there all winter long. But, come 

9 spring, as soon as things warm up, it disappears 

10 very quickly.

11 MS. J. NORMAN: But if it doesn't work 

12 for you, you wouldn't use it. There's plenty of 

13 things that we can use that we don't.

14 CHAIR FAVRE: Thank you very much.

15 MS. J. NORMAN: Uh-hum.

16 MR. D. NORMAN: Thank you.

17 CHAIR FAVRE: Next up is Peggy Miars, 

18 followed by Jackie Sleeper on deck.

19 MS. MIARS: Good morning. I'm Peggy 

20 Miars, Executive Director of OMRI, the Organic 

21 Materials Review Institute.

22 Thank you to the creators of the NOSB 
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1 training presentation which is posted on the NOP 

2 website, and on the screen is slide 7 of the 

3 presentation. But there is a piece missing.

4 OMRI is an important stakeholder in the 

5 organic community. The NOP allows certifiers to 

6 accept OMRI decisions, and OMRI is a technical 

7 report contractor. The NOSB uses those technical 

8 reports in their work, and we have provided 

9 information, when requested by NOSB subcommittees.

10 Certifiers subscribe to OMRI and 

11 receive technical assistance, and they rely on OMRI 

12 product decisions. Certified operations also 

13 rely on the OMRI products list when sourcing inputs 

14 for which the certifier has final approval.

15 And consumers rely on the OMRI list and 

16 seal when they choose products at their home and 

17 garden retailers.

18 So, for those of you new to the NOSB, 

19 you will see OMRI commenting at every meeting, and 

20 we are a resource for material, review information, 

21 and technical assistance.

22 Next, because OMRI was spotlighted in 
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1 the public lately, I am compelled to address some 

2 lies and innuendo. What is true is that OMRI 

3 authored the recent technical report on 

4 carrageenan, as well as several other technical 

5 reports over the last three years.

6 In a recent online report, OMRI was 

7 alleged to include the following statement in the 

8 technical report. Quote, "Carrageenan can be 

9 avoided by sensitive individuals as it is included 

10 in the label." End quote. That statement is not 

11 in the technical report authored by OMRI.

12 That same report insinuated that, 

13 because of a job I held six to twelve years ago, 

14 that I am somehow in collusion with Zea Sonnabend 

15 to continue to allow carrageenan. And that is 

16 quite a stretch of the imagination.

17 There was a statement made yesterday 

18 that OMRI's Board includes a representative from 

19 General Mills. That is a lie. As far as I know, 

20 no one from General Mills has ever served on OMRI's 

21 Board of Directors. However, nothing prohibits 

22 someone from General Mills from serving as long as 
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1 they meet the requirements of the position.

2 OMRI's volunteer Board is made up of 

3 designated seats, similar to the NOSB. Our bylaws 

4 require a certain number or percentage of seats for 

5 organic farmers, handlers, certifiers, public 

6 interest representatives, and input suppliers. 

7 There's also an optional seat for one individual 

8 nominated by the OTA and an optional non-voting 

9 seat for one individual nominated by NOP. 

10 However, I don't believe that the NOP has ever 

11 nominated anyone for our Board.

12 The designated seat design is intended 

13 to ensure that our Board represents the various 

14 stakeholder groups that we serve. None of the 

15 groups except for certifiers and public interest 

16 may comprise more than 25 percent of the Board.

17 OMRI's Board of Directors does not make 

18 product listing decisions and is not involved in 

19 technical report writing.

20 OMRI is a nonprofit organization that 

21 uses a fee-for-service model. Just as certifiers 

22 are paid for the services they provide to their 
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1 customers, OMRI is paid for services that we 

2 provide to our customers.

3 We maintain a strict 

4 conflict-of-interest policy for all staff and 

5 volunteer personnel.

6 OMRI does not take positions for or 

7 against materials. Our job is to review product 

8 compliance to organic standards.

9 (Timer rings.)

10 We are a neutral ISO 17065 accredited 

11 material review organization that was created by 

12 and for the organic community.

13 And I thank you for allowing me to 

14 provide more transparency of OMRI.

15 CHAIR FAVRE: Questions?

16 Harriet?

17 MEMBER BEHAR: As a former OMRI Board 

18 member, thank you for all the work that OMRI does 

19 and how trusted you are in the organic community.

20 MS. MIARS: Thank you.

21 CHAIR FAVRE: Thank you, Peggy.

22 Next up is Jackie Sleeper, with Mabell 
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1 Rivas on deck.

2 MS. SLEEPER: All right. Hello. I'm 

3 Jackie Sleeper, Farm Program Technical Specialist 

4 with Oregon Tilth Certified Organic, or OTCO.

5 We thank the NOSB for their hard work 

6 and dedication to sound improvement of the National 

7 Organic Standards.

8 We were delighted to hear yesterday 

9 that the CACS has added the review of NOP 

10 Instruction 2027 specifically regarding inspector 

11 onsite performance evaluations to their work 

12 agenda, as I will be providing comments on this 

13 today. So, thank you very much.

14 There is no doubt that we must have 

15 well-qualified and trained inspectors performing 

16 high-quality organic inspections. This is vital 

17 to the integrity of the organic industry.

18 Certifiers must conduct annual 

19 performance evaluations of all staff and 

20 contractors, including inspectors, per the rule at 

21 205.501(a)(6). Oregon Tilth evaluates inspectors 

22 each year using collective feedback from operator 
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1 surveys and inspection report reviews, and we 

2 address any need for improvement or additional 

3 training identified during these evaluations.

4 However, we have concerns about the 

5 unintended impacts of this instruction requiring 

6 annual onsite inspector evaluations. We agree 

7 with the comments given yesterday by Pat Kane of 

8 ACA and several other certifiers concerning the NOP 

9 interpreting their own recommendations as 

10 requirements and a lack of clarity about the reason 

11 the NOP feels these field evaluations are necessary 

12 on an annual basis.

13 I would like to address several of the 

14 questions I heard the Board ask about this topic 

15 yesterday.

16 The first, what are the potential and 

17 current impacts? So, one impact is financial. 

18 Cost to perform annual field evaluations adds up 

19 quickly for a larger certifier. OTCO uses over 60 

20 staff and contract inspectors to perform our 

21 inspections in the U.S., Canada, and Mexico. We 

22 estimate the cost for each field evaluation 
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1 averages $500 per inspector, which adds up to over 

2 $30,000 per year. Those costs will end up being 

3 passed onto the certified operations.

4 Another impact is the reduction in the 

5 inspector pool. In an attempt to minimize the 

6 financial impact on our organization and our 

7 clients, OTCO is not using inspectors that don't 

8 perform enough inspections to justify the cost of 

9 their field evaluation.

10 Reducing the inspector pool has impacts 

11 of its own. Fewer inspectors lead to increased 

12 travel costs, as we no longer have inspectors 

13 located in regions with fewer clients. It also 

14 increases the workload on our remaining 

15 inspectors, which could lead to inspector burnout 

16 and potentially lower-quality inspection work.

17 And lastly, it decreases opportunities 

18 for new inspectors to gain experience, as it may 

19 not be financially-viable for certifiers to work 

20 with them.

21 So, what alternative approach might be 

22 taken? OTCO supports allowing certifiers to 
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1 implement a risk-based approach to field 

2 evaluations for inspectors. For example, 

3 certifiers could develop a set of criteria to 

4 identify high-risk inspectors such as those with 

5 less experience or with documented performance 

6 concerns, and have a plan to perform field 

7 evaluations proportionate to risk, such as 

8 annually for high-risk inspectors and once every 

9 three years for all others.

10 We are thankful that the NOSB will take 

11 up this discussion and allow public input on any 

12 recommendation. We believe that, by working 

13 together on this topic, we can address the concerns 

14 and issues this instruction document is trying to 

15 correct and ensure we have a strong evaluation 

16 system for all personnel, including inspectors.

17 Thank you.

18 CHAIR FAVRE: Jean?

19 MEMBER RICHARDSON: Thank you.

20 Just to request that you could email us 

21 your comments, because I don't think we have those 

22 in the written record right now, and it went quickly 
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1 and I didn't get all the notes.

2 MS. SLEEPER: I would be happy to do 

3 that.

4 MEMBER RICHARDSON: Thank you.

5 CHAIR FAVRE: Thank you very much.

6 Next up is Mabell Rivas, followed by 

7 David Hiltz on deck.

8 MS. RIVAS: Hello. My name is Mabell 

9 Rivas, and I am a Senior Reviewer for QAI. For 

10 those new on the Board, QAI is an accredited 

11 certification agency. I'm just going to address 

12 three topics today.

13 On the discussion paper about the idea 

14 of ACAs sampling for the purpose of collecting 

15 data, we think that the only feasible way for ACAs 

16 to perform this function is if is to be made part 

17 of the current testing programs that follow the 

18 criteria in 205.670.

19 However, the proposal as laid out would 

20 not allow us to follow this criteria. For example, 

21 ACAs would have to not be available to take actions 

22 when positive test results are obtained. Also, 
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1 per regulation, test results are to be made 

2 available to the public. The proposal suggests 

3 that we will keep these results confidential.

4 Also, this type investigation places a 

5 financial burden on both the certifier and 

6 operators involved even if the contamination is not 

7 the fault of the operator. For that reason, the 

8 period should fall under the non-organic seed 

9 providers, not the organic industry.

10 On the ancillary substances proposal, 

11 we support the definition, criteria for 

12 compliance, and procedure for review of ancillary 

13 substances. However, on the criteria for 

14 compliance, we echo the concerns others have 

15 expressed about the restriction regarding known 

16 carcinogens.

17 While we agree with the intent, some 

18 substances that appear on this list are commonly 

19 used in materials on 605. So, implementation 

20 might be difficult. For example, silica is widely 

21 used and mineral oil, used in regenerative 

22 cellulose casings.
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1 And then, the third topic is on nutrient 

2 vitamins and minerals. We are concerned that 

3 limiting the use in those situations where 

4 fortification is not required by law will have a 

5 significant negative impact on the industry.

6 We must keep in mind that the main 

7 organic category is confusing and, honestly, the 

8 least preferable. We wonder about how this change 

9 might impact consumer trust.

10 In addition, this change of annotation 

11 will involve the relabeling of hundreds of 

12 products. This could be a real nightmare.

13 On the other hand, we are comfortable 

14 with option 2 and the proposal. We think it 

15 captures the intent for the annotation approved in 

16 1995. In addition, its implementation will be the 

17 least detrimental to the health of the organic 

18 industry. We feel that most certified fortified 

19 products already follow the proposed approach. If 

20 the Board goes with this option, however, we 

21 propose the allowance of vitamins and minerals, 

22 non-synthetic vitamins and minerals, Annotation 3 
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1 in the proposal.

2 We would like to mention that none of 

3 the proposals by the NOSB include reference to 

4 organic dietary supplements or personal care 

5 products. The NOSB recommendation for annotation 

6 as stating it is specifically for foods will 

7 require complete reformulation of hundreds, if not 

8 thousands, of products.

9 Thank you.

10 CHAIR FAVRE: Questions?

11 (No response.)

12 Thank you very much.

13 MS. RIVAS: Thanks.

14 CHAIR FAVRE: Next up is David Hiltz, 

15 followed by Ross White on deck.

16 MR. HILTZ: Good morning and thank you 

17 for the opportunity to comment today.

18 My name is David Hiltz. I'm a 

19 scientist at Acadian Seaplants, a Canadian company 

20 that has been manufacturing aquatic plant products 

21 for over 35 years.

22 After attending the meeting in San 
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1 Diego and hearing minimal opposition to the renewal 

2 of aquatic plant extracts, I was surprised to see 

3 the close results of the renewal vote held last 

4 fall. Reviewing the meeting transcripts, I saw 

5 that Dr. Hadlock Seeley had made comments 

6 suggesting that aquatic plant harvesting is an 

7 unsustainable practice.

8 My colleague, Dr. Raul Ugarte, a 

9 resource scientist with Acadian Seaplants, has 

10 been studying and publishing on the ecology of 

11 aquatic plants for over 25 years. Dr. Ugarte has 

12 submitted detailed comments and supporting 

13 documents to challenge some of these claims. And 

14 while I will try to summarize the key points, I will 

15 suggest that you review carefully the full comments 

16 that were submitted online.

17 Dr. Hadlock Seeley is an activist for 

18 the Rockweed Coalition, a group who seeks to end 

19 commercial rockweed harvesting and would have you 

20 believe that overharvesting is a widespread 

21 practice. She cites a report from the Canadian 

22 Government as evidence, but fails to point out that 
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1 the last incident of overharvest mentioned in that 

2 report was from 25 years ago, before the current 

3 regulations and sustainable harvest methods were 

4 implemented.

5 In fact, using these methods of maximum 

6 set exploitation rates and minimum cut heights 

7 developed in conjunction with Canadian Government 

8 scientists, there have been no recent reports of 

9 overharvesting, despite the considerable 

10 expansion of the industry.

11 The body of evidence simply does not 

12 suggest that rockweed harvesting damages fish or 

13 mollusk habitat. In fact, to the contrary, 

14 recently-published studies have shown no long-term 

15 effects on marine habitat in a 

16 commercially-harvested area.

17 In her comments, Dr. Hadlock Seeley 

18 carefully used photographs showing a bare rock in 

19 a harvested area and suggested it was a good example 

20 of the effects of overharvest. If one looks very 

21 closely at that photograph, one would see that the 

22 rock is surrounded by beds of healthy, full-cover 
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1 rockweed. The bare rock is no more an example of 

2 overharvesting than would a single tree stump be 

3 an example of clear-cutting.

4 Rockweed harvesting is a 

5 closely-regulated industry in Canada, and the 

6 sustainable harvest and technique used for many 

7 years has been recognized globally as a successful 

8 management model that other regulators are now 

9 considering for their areas.

10 The industry needs a healthy resource 

11 in order to continue to grow, and the evidence we 

12 have submitted supports the sustainable management 

13 plan being used is working. We urge the NOP and 

14 the NOSB to carefully consider all of the science 

15 and facts when developing the new technical report 

16 on aquatic plant extracts, as it was mentioned 

17 yesterday.

18 Thank you.

19 CHAIR FAVRE: Questions?

20 (No response.)

21 MR. HILTZ: Thanks.

22 CHAIR FAVRE: Thank you very much.
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1 Next up is Ross White, with Beth Unger 

2 on deck.

3 MR. WHITE: Good morning. My name is 

4 Ross White, and I'm the Nutrition Technical Manager 

5 for the FMC Health and Nutrition business in the 

6 Americas.

7 I'm here today in support of the 

8 continued listing of carrageenan in 205.605(a) as 

9 an approved nonsynthetic ingredient in U.S. 

10 organic foods. Specifically, I would like to 

11 speak to you about the essentiality of carrageenan 

12 in both organic and non-organic foods and highlight 

13 the importance of this ingredient to food 

14 formulators.

15 With over 25 years in the food industry 

16 as a product developer, a formulator, and manager 

17 of other formulators, one thing that has become 

18 very clear to me is that all stabilizers and 

19 emulsifiers are not equal. Though they each 

20 provide various opportunities and challenges 

21 depending on the food systems, the wide range of 

22 functionality provided by carrageenan makes this 
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1 particular stabilizer essential to the food 

2 formulator.

3 Carrageenan can provide functionality 

4 at very low use levels, parts per million in many 

5 cases, and the range of its functionality often 

6 allows formulators to create products without the 

7 need for additional stabilizers. In specific 

8 instances like organic infant formula in the United 

9 States, carrageenan is the only approved choice of 

10 formulators.

11 Carrageenan can be used to achieve a 

12 range of textures from a low-viscosity refreshing 

13 mouthfeel to something that is creamy and 

14 indulgent. Many other additives must often be 

15 used in combination to achieve the same desired 

16 effects, and this can result in higher formulating 

17 cost, greater complexity in formulating, and 

18 longer ingredient declarations.

19 Further, there are often challenges 

20 that occur when formulating with many of the other 

21 additives, and that ranges from instability in the 

22 form of separation to a lack of cohesiveness, all 
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1 resulting in reduced quality, compromised 

2 esthetics, and shorter shelf life in some cases 

3 that can deter product quality and repeat purchase.

4 Given the range of functionality and 

5 texture that carrageenan can provide, it also has 

6 become an essential ingredient when formulating 

7 healthier food options. Our country is faced with 

8 rising obesity and chronic disease, and when fats, 

9 salt, sugar, and other ingredients are reduced or 

10 removed, the foods lose the texture that consumers 

11 have come to accept. Carrageenan is essential in 

12 replacing these textural attributes and can often 

13 do so alone, ensuring that consumers can select 

14 healthy choices without sacrificing taste and 

15 texture. And this is not always the case when 

16 combinations of other ingredients and emulsifiers 

17 are used.

18 Reformulating away from carrageenan 

19 can be a very lengthy and expensive process. It 

20 often results in reduced product quality.

21 Many organic food producers have 

22 experienced this recently, and several have 
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1 admitted that, in spite of their beliefs in the 

2 safety of carrageenan, their reformulations were 

3 driven by flawed science and misinformed 

4 consumers. Many have struggled to reformulate 

5 their products and maintain the quality that those 

6 same consumers expect to have each time they buy 

7 their product. And that further proves the 

8 essentiality of carrageenan and the need to have 

9 it as an approved option for use in foods of an 

10 organic nature and beverages as well.

11 And then, here you can see a list of our 

12 customers and partners who stand with us in 

13 affirming the safety of carrageenan and the 

14 essentiality of its use in organic foods.

15 Thank you.

16 (Timer rings.)

17 CHAIR FAVRE: Good job.

18 MR. WHITE: Thanks.

19 CHAIR FAVRE: Questions?

20 Tom?

21 VICE CHAIR CHAPMAN: Are any of those 

22 customers producers of organic products?
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1 MR. WHITE: Yes, some are.

2 VICE CHAIR CHAPMAN: Which ones?

3 MR. WHITE: Specifically, there are 

4 individuals that have organic products in their 

5 product line. So, Chicago Vegan Foods, and there 

6 are a few others up there. I'm not specifically 

7 clear on all those that are up there, though.

8 VICE CHAIR CHAPMAN: Okay. Thank you.

9 I wanted to ask you a question about a 

10 settling of a products in the use of carrageenan, 

11 particularly around liquid infant formula.

12 MR. WHITE: Sure.

13 VICE CHAIR CHAPMAN: Previous 

14 commenters yesterday spoke to that being a 

15 necessity. Can you speak a little bit more to why 

16 it is needed in liquid infant formula, in 

17 particular?

18 MR. WHITE: Infant formula is a 

19 specific case, Tom. And the concern that I have 

20 is, when formulators are looking at applications, 

21 there is a wide diversity in the range of those 

22 applications. So, specifically in infant 
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1 formula, we talked about yesterday the shaking 

2 option. I don't think that is very practical in 

3 many cases. But, as you get into more complex 

4 formulations that might require higher protein or 

5 higher degrees of fortification, that is really 

6 where the essentiality of carrageenan comes in.

7 And it can be used alone. It is not to 

8 say there aren't any other options, but I think the 

9 goal is to provide consistency so that those 

10 consumers are getting the same product over and 

11 over again.

12 I would say, when you get beyond infant 

13 formula and you get to medical nutritionals, 

14 high-protein beverages, we heard some producers 

15 earlier that talked about the yogurt application. 

16 I think the theme there is that formulations are 

17 different within a category. As complex 

18 ingredients change, as the other ingredients that 

19 they have in there change, you heard both success 

20 and failure stories about their ability to 

21 reformulate products.

22 So, I think the key is essentiality, so 
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1 that it is across the board; really widening the 

2 options for the organic consumer. We want to make 

3 sure that, as that organic market grows, people 

4 have more options, not fewer options.

5 CHAIR FAVRE: Thank you very much.

6 MR. WHITE: Thank you.

7 CHAIR FAVRE: Next up is Beth Unger, 

8 with Stephen Walker on deck.

9 MS. UNGER: Hello. I am Beth Unger. 

10 I work with CROPP Cooperative, a farmer-owned 

11 cooperative producing nothing but organic products 

12 under the Organic Valley and the Organic Prairie 

13 brands.

14 There are three items I would like to 

15 cover and, also, give you some of this time back 

16 because the day is fading fast.

17 Cellulose is one of the items that is 

18 up for 2018 sunset review that we wanted to see 

19 remain on the list. We use cellulose in two 

20 different ways in our Organic Prairie products. 

21 We use peelable cellulose casings on our hotdogs. 

22 It is a very important part of that process.
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1 One of the questions you asked is, what 

2 is the alternative? Plastic. Not a good 

3 alternative. It doesn't function as well, and it 

4 is certainly is not as sustainable.

5 The other form of cellulose we use is 

6 a powdered cellulose as an anticaking material for 

7 our shredded cheeses. It is used in a minimal 

8 quantity to have the function that is desired to 

9 keep the cheese from clumping.

10 The next material that we would like to 

11 see remain on the list in the 2018 realm is 

12 potassium hydroxide. Buttermilk is a byproduct of 

13 the butter-making and the potassium hydroxide is 

14 used as a processing aid to adjust the pH. The 

15 alternatives to potassium hydroxide are sodium 

16 hydroxide or calcium hydroxide. Both are very 

17 poor choices due to the harsh effect it would have 

18 on the proteins.

19 And finally, the discussion document 

20 that was put out there on nutrient vitamins and 

21 minerals we found to be very interesting. I had 

22 a little technical error in my written comments. 
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1 So, I want to make sure I correct that. We are 

2 advocating for option No. 2.

3 I think it is interesting that you all 

4 are bringing this discussion document to the table, 

5 especially in light of the fact that there was a 

6 proposed rule put out that pretty well said it all. 

7 We sure would like to see that one come to fruition 

8 and not have this be on your plate at this time. 

9 But, to be perfectly clear, we would like the 

10 annotation to read, "vitamins and minerals 

11 identified as essential in 21 CFR 101.9 or as 

12 required for infant formula by 21 CFR 107.100 or 

13 107.10".

14 Please complete the rulemaking on the 

15 2012 proposed rule.

16 And I will let the NOSB go back to the 

17 important work that they do.

18 Thank you.

19 CHAIR FAVRE: Tom?

20 MS. UNGER: I know.

21 VICE CHAIR CHAPMAN: Do I even need to 

22 ask?
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1 MS. UNGER: Yes, we're done with it.

2 (Laughter.)

3 VICE CHAIR CHAPMAN: And have you seen 

4 any changes in product quality or consumer 

5 complaints, sales of those products?

6 MS. UNGER: I really wasn't prepared to 

7 respond to you. I will tell you that, as a 

8 consumer, one of the toughest changes that we 

9 made -- and, you know, I am no R&D person at 

10 all -- one of the tougher changes was removing it 

11 from the ultra-pasteurized heavy cream. And so 

12 now, that has been replaced with gellan gum. I 

13 find that it is not quite the same. It is still 

14 workable, but not the same.

15 VICE CHAIR CHAPMAN: And then, the 

16 application, that's for the whipping properties or 

17 is that for separation, or what? What is the --

18 MS. UNGER: Now whip-ability, 

19 actually, is the problem that I am seeing.

20 VICE CHAIR CHAPMAN: Thank you.

21 MS. UNGER: Thanks.

22 CHAIR FAVRE: Harriet?
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1 MEMBER BEHAR: Beth? Beth, come back, 

2 Beth.

3 (Laughter.)

4 CHAIR FAVRE: You are not released from 

5 here.

6 (Laughter.)

7 MS. UNGER: Yes, yes. Here I'm trying 

8 to give you time back.

9 MEMBER BEHAR: I can catch you at the 

10 Driftless Café sometimes.

11 MS. UNGER: Yes, exactly.

12 MEMBER BEHAR: Do you use sodium 

13 lactate or potassium lactate?

14 MS. UNGER: No. We used to use sodium 

15 lactate in the meat products. And so, I think that 

16 the organic meat company wouldn't mind seeing that 

17 on the list, but we're not currently using it.

18 MEMBER BEHAR: Did you support it for 

19 listing?

20 MS. UNGER: No. We were silent on that 

21 topic.

22 CHAIR FAVRE: Now you can go. Thank 
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1 you.

2 Next up is Stephen Walker, followed by 

3 Lyn Coody on deck.

4 MR. WALKER: Good morning. I'm Steve 

5 Walker, Operations Manager with MOSA.

6 We now certify over 1700 organic 

7 operations across the U.S. And from 10 written 

8 comments we submitted, I want to touch on excluded 

9 methods terminology, seed purity, humility, and 

10 morality.

11 We appreciate your challenging work in 

12 trying to keep pace with biotechnology's rapid 

13 changes. The organic label is the consumer's best 

14 non-GMO guarantee.

15 The terminology proposal will help to 

16 strengthen our non-GMO message, which consumers 

17 increasingly seek. We find the definitions to be 

18 clear and useful. We appreciate the international 

19 perspective. This is a global issue.

20 We also like the principles and 

21 criteria in the proposal. They are honorable and 

22 seem like they will enable evaluation of unforeseen 
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1 new biotech developments. We think the 

2 terminology chart will aid consistency and 

3 enforcement. The proposal gives a lot we can use 

4 to more clearly define our lines while still 

5 enabling a simple organic is non-GMO message.

6 We have some enforcement concerns. We 

7 occasionally use GMO test results, but 

8 interpreting these is problematic without better 

9 info on thresholds, and some excluded methods won't 

10 be reviewed by testing.

11 We also noted challenges with testing 

12 for seed purity. We simply need more data to make 

13 fair decisions that enforce consumer expectations, 

14 but don't hurt organic farmers using sound 

15 prevention strategies, but victimized by pervasive 

16 GMO frauds.

17 Testing can be a good tool with more 

18 context, but we are more accustomed to working with 

19 affidavits and such from suppliers. We would like 

20 to assist development of a robust, binding 

21 declaration form inspired by the terminology 

22 proposal to make enforcement practical.
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1 Now, on humility and morality, usually 

2 when folks ask me how it is going at MOSA, I first 

3 talk about our great staff. I love working with 

4 about 30 smart, friendly, and sensible folks who 

5 give their best to our work. We know a lot about 

6 a lot, but we're not employing folks with advanced 

7 degrees in modern biotechnology. So, we need to 

8 rely on other experts.

9 And we believe that there is a moral 

10 imperative for the companies and individuals who 

11 possess expert knowledge to be responsible and 

12 transparent. Human innovation is gift, but humans 

13 are fallible.

14 Biotech has potential for good, but its 

15 use must be respectful to all life, plant, animal, 

16 human, and planet. That is in line with the 

17 principles in the proposal which take a long and 

18 global view and include fairness. Fairness 

19 demands enabling marginalized voices to be heard.

20 We recognize our limits, but we also 

21 have wisdom to bring. Open communication and 

22 mutual humility and heart are keys.
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1 And I'm out of time, but if you give me 

2 a lead, I would love to get some words from Pope 

3 Francis on the record.

4 (Laughter.)

5 (Timer rings.)

6 CHAIR FAVRE: I'll give you that. Go 

7 ahead.

8 MR. WALKER: All right. This is from 

9 the much-talked-about encyclical on the 

10 environment that was released last summer. It is 

11 called "On Care for Our Common Home".

12 In discussing biotech, Pope Francis 

13 said, "Certainly, these issues require constant 

14 attention and a concern for their ethical 

15 implications. A broad, responsible scientific 

16 and social debate needs to take place, one capable 

17 of considering all the available information and 

18 of calling things by their name.

19 "It sometimes happens that incomplete 

20 information is not put on the table and selection 

21 is made on the basis of particular interests. Be 

22 they political, economic, or ideological, this 
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1 makes it difficult to reach a balanced and prudent 

2 judgment on different questions, one which takes 

3 into account all the pertinent variables. 

4 Discussions are needed in which all those directly 

5 or indirectly affected, farmers, consumers, civil 

6 authorities, scientists, seed producers, people 

7 living near fumigated fields, and others can make 

8 known their problems and concerns and have access 

9 to adequate and reliable information in order to 

10 make decisions for the common good, present and 

11 future."

12 CHAIR FAVRE: Thank you.

13 Any questions?

14 Zea?

15 MEMBER SONNABEND: Well, not exactly a 

16 question, but I really did appreciate your comments 

17 this time. I thought it is really important that 

18 we keep looking at the forest in between the trees, 

19 even though, you know, we're definitely in the 

20 trees on some of these issues. So, even the Pope 

21 seems to recognize that. So, that's good.

22 MR. WALKER: Thank you.
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1 CHAIR FAVRE: Harriet?

2 MEMBER BEHAR: I know you work with a 

3 lot of processors. Are there many processors that 

4 are using either carrageenan or sodium or potassium 

5 lactate?

6 MR. WALKER: Maybe I could have seen 

7 that one coming, huh?

8 (Laughter.)

9 I'll have to defer. I used to be one 

10 of our primary processor reviewers, and I'll plead 

11 humility on this one. I'm a little out of touch 

12 with that lately.

13 We could anecdotally give information, 

14 sort of like we did in submitting comments on the 

15 various materials up for sunset review.

16 CHAIR FAVRE: Thank you very much.

17 MR. WALKER: Thank you.

18 CHAIR FAVRE: Next up is Lyn Coody, and 

19 on deck is Kate Houston.

20 MS. COODY: Good morning. My name is 

21 Lyn Coody. I'm a Policy Analyst for the Organic 

22 Produce Wholesalers Coalition. OPWC is comprised 
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1 of eight businesses that distribute fresh organic 

2 produce to customers located across the United 

3 States and internationally.

4 Many of our businesses were early 

5 participants in the organic community and have 

6 continued to play an active role in shaping the 

7 infrastructure of the organic trade.

8 We work to express our members' ideas 

9 as well as to provide a conduit to the Board for 

10 the voices of the certified growers who supply our 

11 businesses.

12 We submitted extensive written 

13 comments. So, today I would like to touch on only 

14 a few of those topics.

15 First is inerts. OPWC supports the 

16 recent activities of the Inerts Working Group to 

17 collaborate with the EPA's Safer Choice Program. 

18 While this collaboration is underway, OPWC urges 

19 continued use of the existing system for regulating 

20 inert ingredients, known as List 4.

21 We think it is vitally important to 

22 avoid the tremendous disruption of the organic 
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1 trade that would occur should there be a gap between 

2 the dissolution of one system for regulating inerts 

3 and implementation of an updated system.

4 We also support the relisting of List 

5 3 inerts as a 2018 sunset material for use in 

6 passive pheromone dispensers, which are 

7 extensively used in the production of fruits and 

8 vegetables, both for monitoring insect populations 

9 as well as for controlling insects through mating 

10 disruption. In our written comments, we included 

11 some very ugly pictures of what happens when you 

12 don't passive pheromone dispensers for insect 

13 control.

14 Next, paracetic acid. We support 

15 relisting of paracetic acid for crops, both as a 

16 sanitizer disinfectant and for disease control. 

17 Our initial polling of our growers highlighted 

18 their use of paracetic acid for many different 

19 purposes. For some uses, paracetic acid was 

20 preferred as an alternative to chlorine products, 

21 and some growers pointed out its extensive need for 

22 it with regard to alternatives for fire blight 
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1 control in apples and pears, a very, very difficult 

2 problem for them now that they don't use 

3 antibiotics for controlling fire blight.

4 Third, hypochlorous acid produced by 

5 electrolysis. Because use of this material has 

6 been allowed by some ACAs, OPWC members invested 

7 in the equipment to produce hypochlorous acid on 

8 site, with many advantages over other sources of 

9 chlorine. We use it for cleaning equipment and 

10 food-contact surfaces, such as sorting tables, 

11 packing lines, and tools, as well as for general 

12 facility maintenance.

13 In addition, we note that hypochlorous 

14 acid is approved as a disinfectant during the 

15 washing and peeling of raw fruits and vegetables. 

16 This use is essential for ensuring post-harvest 

17 safety for the fresh produce we handle.

18 And last, I wanted to say a few words 

19 of thanks to the Seed Purity Advisory Task Force. 

20 We hope that it will be established in the USDA, 

21 and we pledge to help from any trade-based efforts 

22 to work toward protection for genetic engineering.
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1 Thanks.

2 CHAIR FAVRE: Thank you, Lyn.

3 Tom?

4 VICE CHAIR CHAPMAN: Thank you, Lyn.

5 So, in your written comments, you're 

6 one of the few or maybe the only organization that 

7 went on the record in support of the PPM changes. 

8 Can you speak at all to that here?

9 MS. COODY: Yes. We did support the 

10 PPM changes. Well, we especially appreciate a 

11 clear path toward understanding how we are supposed 

12 to interact with the NOSB. That was our main 

13 reason for supporting it.

14 We also, as procedurally-based 

15 certified entities, understand that a clear manual 

16 is important for functioning of the Board itself. 

17 That was another important reason for doing so.

18 We recognize that the Policy Manual now 

19 does document the existing current sunset proposal 

20 or changes which were promulgated a while ago, 

21 mostly at the behest of the NOP. And we know that 

22 some folks are concerned about certain elements of 
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1 that.

2 But we think it is important to know 

3 that these are the rules in place; this is the game 

4 we are playing together now. And we just 

5 appreciated the effort to try to make it clear how 

6 things would run. So, those were some of the 

7 important reasons that we did decide to speak in 

8 favor of it.

9 We did also note that we understood the 

10 reason that you did not put the redline changes in 

11 the first time, because when you change around 

12 manuals a lot, it basically shows everything in 

13 redline. So, yes, it is a little bit hard. It is 

14 difficult when you have to make major changes, but 

15 we do appreciate the effort. So, that is why we 

16 supported it.

17 VICE CHAIR CHAPMAN: Thank you.

18 CHAIR FAVRE: Thanks, Lynn.

19 MS. COODY: Uh-hum.

20 CHAIR FAVRE: I also wanted to tell you 

21 I appreciated that you guys did a good job at 

22 getting very succinct, but well-thought-out 
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1 comments to us. So, I appreciate particularly the 

2 fact that you were able to get your point across 

3 in a very succinct manner.

4 MS. COODY: Well, thank you. I 

5 appreciate it. We do work hard at it. And next 

6 time, we have even more comments from our growers 

7 as an addendum. We collect them and put them in 

8 the second round of sunset because we now we know 

9 there's two rounds of sunset.

10 CHAIR FAVRE: Right.

11 MS. COODY: Okay. Thanks.

12 CHAIR FAVRE: Thank you very much.

13 Okay. Next up is Kate Houston, with 

14 Clara Poffenberger on deck.

15 MS. HOUSTON: Good morning, and almost 

16 good afternoon.

17 Thank you very much for the opportunity 

18 to submit comments to the written record as well 

19 as to speak with you today.

20 I represent Cargill. We are a food and 

21 agriculture company and a supplier of food and 

22 ingredient products to a wide range of 
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1 food-manufacturing companies. Together with 

2 farmers and our customers, governments and 

3 communities, we really pride ourselves on finding 

4 new and innovative ways that we can help people 

5 thrive.

6 I am here today because Cargill is a 

7 manufacturer and a distributor of a wide range of 

8 seaweed-based products, including carrageenan. 

9 As carrageenan is extracted from seaweed, we 

10 believe it is a safe and suitable ingredient for 

11 products that are certified as Halal, Kosher, 

12 vegan, and it is often used in place of animal-based 

13 products.

14 We also believe carrageenan is a safe 

15 and suitable ingredient for use, and continued use, 

16 in organic certified products. Others have 

17 covered the safety question. So, I'm not going to 

18 spend a lot of time on my comments, but will just 

19 say that many of the challenges and interest in 

20 reformulation we believe strongly is more to do 

21 with concern about perception of the ingredient, 

22 not based on a clear evidence of safety that has 
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1 been demonstrated and confirmed by a wide range of 

2 the most authoritative food safety experts 

3 globally, including most recently, since your last 

4 review of carrageenan, the confirmation by JECFA 

5 in 2015.

6 The production of seaweed that is used 

7 to make carrageenan is also sustainable. It 

8 supports family farmers and it benefits marine 

9 environments.

10 Extraction from dried seaweed is 

11 something you could actually replicate at home. 

12 It is minimal processing. It has been done for 

13 hundreds of years, if not longer.

14 We believe that carrageenan production 

15 is consistent with organic principles, as well as 

16 Cargill's commitment to feeding the world in a 

17 responsible way, reducing environmental impact, 

18 and in improving the communities and citizens where 

19 we live and work.

20 I want to just mention briefly a bit 

21 about the farmer story behind carrageenan because 

22 I think it is important context for the decision. 
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1 We work with small farmers and family farmers who 

2 we depend on and have direct relationships and 

3 personal relationships in harvesting the seaweed 

4 for production of carrageenan. We know that the 

5 market for this product is a part of the livelihood.

6 (Timer rings.)

7 We hope that you think about the 

8 decision to remove and the impact that it can have 

9 on those farmers and their livelihoods. We --

10 CHAIR FAVRE: Thank you. I'm sorry, 

11 we are going to have to stop you there. Your time 

12 has gone off and we're running behind schedule.

13 MS. HOUSTON: Okay. That's fine.

14 CHAIR FAVRE: My apologies.

15 MS. HOUSTON: So, thank you very much 

16 for the opportunity, and we are happy to answer any 

17 questions here or in writing.

18 CHAIR FAVRE: Okay. Tom, you had a 

19 question?

20 VICE CHAIR CHAPMAN: So, you spoke to 

21 how simple the carrageenan manufacturing process 

22 is; it could be done in a kitchen. It sounds like 
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1 it is a process itself that would be allowable under 

2 organic certification. So, then, the question 

3 goes to the raw material.

4 There are several organic seaweeds, 

5 dozens certified to the National Organic Program 

6 already. So, why is there not organic carrageenan 

7 in the marketplace?

8 MS. HOUSTON: Well, as of this point, 

9 we have had the opportunity to be on the list. 

10 There was a decision made by this body in the past 

11 looking at the full range of evidence, that the 

12 production under current practices was appropriate 

13 for use on this list. And the market has continued 

14 to rely on those sources in use of 

15 organically-certified products. So, that has 

16 been deemed to be acceptable as part of the 

17 standards put forward by the Department.

18 VICE CHAIR CHAPMAN: So, Cargill 

19 hasn't or your suppliers haven't made any effort 

20 to get certified organic?

21 MS. HOUSTON: I'm not aware that there 

22 has been a demand or an ask for that. I can go back 
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1 to our business and ask them that question 

2 directly. I would be happy to follow up with you, 

3 if you are interested in finding out.

4 VICE CHAIR CHAPMAN: That would be 

5 great. Thank you.

6 MS. HOUSTON: Yes. Sure.

7 VICE CHAIR CHAPMAN: Yes.

8 CHAIR FAVRE: Others?

9 (No response.)

10 Thank you very much.

11 MS. HOUSTON: Thank you.

12 CHAIR FAVRE: Okay, folks, we are going 

13 to make a little bit of an audible here, call an 

14 audible. Because we are running so late, we are 

15 going to have two more presenters and, then, we are 

16 going to take a break for lunch.

17 So, our next presenter is Clara 

18 Poffenberger and, then, we will have Johanna 

19 Mirenda on deck.

20 MS. POFFENBERGER: Good afternoon. 

21 I'm a member of New Family Farm in Boyce, Virginia.

22 My daughter is actually the farmer and 
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1 is working towards biodynamic certification. She 

2 has done all the homework or has begun to do all 

3 the homework that it takes to be a full working 

4 organic farm. She has attended a number of 

5 workshops and has educated me.

6 I have been a practicing environmental 

7 attorney for 26 years and, of course, in that have 

8 explored and done plenty of research on 

9 agricultural environmental issues. But, for over 

10 29 years, I have been a mom and have read nutrition 

11 labels, studied nutrition information, and sought 

12 really zealously to provide healthy foods to my 

13 children.

14 And this summer I will become a 

15 grandmother, and my daughter will have the same 

16 task, and I will be continuing to help her as she 

17 tries to decide what is the best way to raise her 

18 children, luckily, on an organic farm, but she will 

19 still be purchasing in the market.

20 In the process of being a mom and making 

21 decisions about food, I have begun to rely on the 

22 organic label. And now, as a farm owner, I have 
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1 become concerned about the integrity of the organic 

2 label, especially as I try to explain to people what 

3 the organic label means and what other labels mean.

4 So, I am here simply today to urge you 

5 to continue to protect the integrity of the organic 

6 label. It is really difficult for young families 

7 and growing families and people in general, the 

8 layperson without all the knowledge in this room, 

9 to actually make decisions about food based on 

10 internet information.

11 The organic label is something that we 

12 need to trust. So, to make my comments really 

13 short, I urge this Board to follow the 

14 recommendations submitted by the Cornucopia 

15 Institute and the other small organic farmers. I 

16 particularly urge the Board to provide support as 

17 it continues to deliberate and make decisions for 

18 sustainable farmers, biodynamic farmers, and 

19 permaculture, as I understand that permaculture is 

20 the way that we will feed the future with healthy 

21 foods that are also environmentally-protective 

22 farms.
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1 Specifically, I understand that the 

2 Policy and Procedures Manual changes that you 

3 proposed would actually not continue that goal. 

4 So, I urge you to table those changes until changes 

5 to the manual can be made with full public 

6 participation and involvement of the organic 

7 industry.

8 I ask that you maintain transparency of 

9 this Board, as I will now be paying a lot more 

10 attention to your activities, as I think the 

11 organic industry doesn't need any secrecy or any 

12 behind-closed-door decisions.

13 Thank you.

14 CHAIR FAVRE: Questions?

15 Tom?

16 VICE CHAIR CHAPMAN: Can you highlight 

17 areas of the proposed PPM changes that you are 

18 concerned about in regards to the transparency or 

19 our operations?

20 MS. POFFENBERGER: Well, there's a 

21 number of them that Cornucopia Institute lists. I 

22 understand that the manual -- again, I don't have 
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1 the whole list in front of me, but I have read them 

2 a couple of times -- that there is a Director that 

3 will no longer be involved or no longer be on the 

4 Board. I don't remember all the details. Again, 

5 the Cornucopia Institute has listed those out.

6 VICE CHAIR CHAPMAN: The Staff 

7 Director position, that is the one you are 

8 concerned about?

9 MS. POFFENBERGER: Actually, they list 

10 a number of different changes that the manual 

11 includes, and I don't remember them all. I don't 

12 have it in front of me.

13 VICE CHAIR CHAPMAN: Okay. Thank you.

14 MS. POFFENBERGER: Thanks. Sorry.

15 CHAIR FAVRE: Thank you.

16 Next up is Johanna Mirenda, and then, 

17 we'll have lunch after that.

18 MS. MIRENDA: Okay. Hi, everyone. 

19 My name is Johanna Mirenda. I'm the Technical 

20 Director of OMRI, the Organic Materials Review 

21 Institute.

22 I am using my time today to make a very 
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1 brief comment on the importance of the National 

2 Organic Program to issue final guidance on the 

3 classification of materials.

4 The review of materials is a 

5 foundational aspect of the organic certification 

6 process. Nearly every operation across all scopes 

7 uses input materials in one form or another. 

8 Material review is performed on a daily basis by 

9 certifiers and material review organizations. 

10 The compliance of an operation can depend entirely 

11 on the review decision of a single input material.

12 With so many materials and so many 

13 organizations making material review decisions, 

14 and the significance of a review decision in terms 

15 of compliance, it is critical that clear guidance 

16 is in place for reviewers to make consistent and 

17 accurate material review decisions.

18 The process of reviewing a material 

19 starts with the classification of the material as 

20 synthetic or nonsynthetic. This deceptively 

21 straightforward decision can be highly scientific 

22 and nuanced. Who can forget the sage of corn steep 
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1 liquor in 2010?

2 (Laughter.)

3 For some materials, the science and 

4 nuance is publicly discussed in conjunction with 

5 a technical report on the material, and a final and 

6 informed recommendation is made by the NOSB. But 

7 the reality is that most individual substances used 

8 in organic crop and livestock input materials have 

9 not been reviewed by the Board.

10 Due to the structure of the NOP 

11 regulations and the National List for crops an d 

12 livestock production, only allowed synthetics and 

13 prohibited nonsynthetics need to undergo NOSB 

14 review and appear in the NOP regulations. This 

15 means that the countless number of allowed 

16 nonsynthetic substances that are permitted for use 

17 in organic crop and livestock production are not 

18 petitioned to the NOP or reviewed by the NOSB.

19 These allowed nonsynthetics are 

20 approved based only on a classification decision 

21 made by a certifier or a material review 

22 organization. Reviewers are responsible for 
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1 making these classification decisions in order to 

2 carry out routine material review as part of the 

3 certification process.

4 In the absence of final comprehensive 

5 NOP guidance, the industry relies on limited 

6 regulatory definitions, piecemeal precedents set 

7 at NOSB meetings, or in NOP Policy Memos, and a 

8 series of draft NOP guidances published in 2013. 

9 Final versions of these guidances and the Program 

10 Handbook are needed in order to make material 

11 classification policies consistently applied and 

12 enforced.

13 We urge the NOP to move forward in 

14 publishing these final guidances and integrate the 

15 public comments provided on the 2013 drafts. Your 

16 efforts will result in a valuable resource that 

17 will empower certifiers and material review 

18 organizations to make consistent and accurate 

19 material review decisions in alignment with NOP 

20 expectations.

21 And from the NOP's report yesterday, it 

22 sounds like we might see these guidances this 
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1 summer. So, we really look forward to that, and 

2 we thank you for your work on this issue and for 

3 considering our comments.

4 CHAIR FAVRE: Thank you.

5 Questions?

6 (No response.)

7 Thank you very much.

8 MS. MIRENDA: Thanks.

9 CHAIR FAVRE: Okay, folks, we have 

10 blown our perfect score from yesterday with the 

11 schedule. So, like I said, we are going to have 

12 to change out the agenda a little bit. We do have 

13 an expert panel that is scheduled on the agenda to 

14 speaking starting at 1:15. We are going to push 

15 that back a little bit.

16 But, in order to accommodate the public 

17 comments, we are going to shorten our lunch a little 

18 bit. I know this is going to mess with everybody's 

19 head. But I would like everybody back here at one 

20 o'clock.

21 We are going to try to accommodate the 

22 public comment schedule, and then, we will start 
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1 the technical panel after that.

2 So, everybody back here at one o'clock, 

3 please.

4 Thank you.

5 (Whereupon, the foregoing matter went off the record for lunch at 12:19 

6 p.m. and went back on the record at 1:05 p.m.)

7 CHAIR FAVRE: Board Members, if you are 

8 here, please take your seats.

9 Okay, folks, we are going to start back 

10 with our public comments. In the interest of 

11 trying to get back on schedule as much as possible, 

12 I ask our Board members to keep your questions 

13 brief.

14 Okay. Please go ahead.

15 MR. SASTRA: Good afternoon, everyone. 

16 My name is Agus Sastra. I am from Bali, Indonesia.

17 I grew up on a seaweed farm in 

18 Indonesia. In 1979, my father, working with FMC, 

19 to start the seaweed farm in Indonesia. I came 

20 here today to represent over 25,000 seawood farming 

21 families in Indonesia.

22 Before seaweed farming happened in 
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1 Indonesia, it was a difficult life. People did 

2 dynamite fishing. They broke the coral, 

3 destroying fish habitat, living it in bad 

4 condition, bad sanitary, no electricity. The 

5 children cannot go to school because their families 

6 have no money, no future for them.

7 But everything changing after seaweed 

8 happened in Indonesia. They farm seaweed. They 

9 have money. They leave the dynamite fishing. The 

10 coral is growing back. The fish come to the beach. 

11 Their children now can go to school. Some of the 

12 children now become a police, nurse, work at their 

13 governments, become seaweed traders. Economics 

14 are growing. Now they have a house with clean 

15 sanitary and electricity. Seaweed also became a 

16 tourist attraction.

17 I also want to tell you how does the 

18 seaweed family work. The important things, we do 

19 not use chemical fertilizer to grow seaweed.

20 The first step, seed selecting. We are 

21 tying to the line, and we are planting on the sea. 

22 After six weeks, we harvest, and half the seaweed 
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1 we take to the new seedling and we plant another 

2 one. After three days drying, the farmer can sell 

3 it.

4 In the end, we hope the NOSB will 

5 understand how many tens of thousands jobs and 

6 lives depend on the seaweed market and carrageenan.

7 Thank you for hearing my story, and 

8 please continue to allow the use of carrageenan in 

9 organic food.

10 CHAIR FAVRE: Thank you very much. 

11 Thank you for bringing your perspective and your 

12 comments to us.

13 Any questions for him?

14 Scott?

15 MEMBER RICE: Terima kasih (speaking 

16 Indonesian) for coming so far.

17 MR. SASTRA: Okay. Sama-sama 

18 (speaking Indonesian).

19 CHAIR FAVRE: Thank you very much.

20 MR. SASTRA: Thank you. Thank you.

21 CHAIR FAVRE: Next is up Erick Ask, 

22 with Bill Blakemore on deck.
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1 MR. ASK: Yes, my name is Erick Ask. 

2 I'm FMC's Corporation Seaweed Development Manager.

3 I first worked with seaweed farming as 

4 a Peace Corps volunteer in the Philippines in the 

5 1980s, introducing sustainable alternative 

6 livelihoods to counter destructive fishing and 

7 overfishing.

8 As we talk about seaweed farming today, 

9 it is important to keep in mind how and where the 

10 carrageenan industry first began. It started in 

11 Scituate, Massachusetts in the 1840s, based on the 

12 collection of Chondrus crispus seaweed. By the 

13 1930s, processing took place in New Bedford, 

14 Massachusetts and, later, Rockland, Maine, with 

15 those companies combining in the 1950s, forming 

16 Marine Colloids.

17 As demand for carrageenan grew, Marine 

18 Colloids developed other carrageenan seaweed 

19 sources in North and South America, Africa, and 

20 Asia. In addition, they invented cultivation of 

21 the tropical carrageenan seaweeds with the 

22 University of Hawaii and the Philippine Government 
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1 in the 1960s. FMC purchased Marine Colloids in the 

2 mid-seventies and continued the effort to assure 

3 sustainable carrageenan seaweed supplies.

4 When carrageenan seaweed farming was 

5 invested, best practices were developed to ensure 

6 optimal productivity and sustainability of the 

7 seaweed as well as the health and safety of the 

8 farmers. That continues to this day.

9 For example, FMC is now working with the 

10 New England Aquarium's Sustainable Seafood Program 

11 in Boston to promote best practices for sustainable 

12 seaweed farming and ocean harvesting.

13 The Marine Stewardship Council and the 

14 Aquaculture Stewardship Council are working 

15 together to develop sustainable seaweed 

16 certification standards. They have created a 

17 Sustainable Seaweed Standards Committee, and I am 

18 one of eight Committee members. FMC is also 

19 working with the Marine Stewardship Council on 

20 pilot testing of these standards.

21 It is important to note that seaweed 

22 farms provide valuable environmental services. 
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1 First, they are nutrient sinks, important today 

2 given the nutrient loading from ag and urban 

3 runoff. Second, they are habitats providing 

4 structure for fish and invertebrates where there 

5 wasn't any, similar to artificial reefs. And 

6 third, they are primary production for herbivores. 

7 All this enhances the coastal marine ecosystem.

8 Farms also promote a stewardship 

9 mentality in the coastal communities. Just like 

10 organic farmers in this room rely on healthy soil, 

11 seaweed farmers rely on healthy seas.

12 Today there are more than 33,000 

13 seaweed farming families around the world. Their 

14 number may not seem enormous, but the global impact 

15 is real, not only to their lives and their 

16 communities, but also on our oceans, our food 

17 supply, and the health of our planet.

18 Thank you very much for this 

19 opportunity to comment. I urge you to consider the 

20 global impact of your decision and, therefore, to 

21 vote in favor of the continued inclusion of 

22 carrageenan on the National List.
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1 Thank you.

2 (Timer rings.)

3 CHAIR FAVRE: Afternoon prize for best 

4 ending.

5 (Laughter.)

6 Questions?

7 Dan?

8 MEMBER SEITZ: Does marine pollution 

9 enter into seaweed in any way and, if so, what 

10 happens through the processing cycle?

11 MR. ASK: Okay. So, when we say 

12 seaweed, you know, there's 25,000 species. 

13 There's only about 50 that are commercial.

14 And the other aspect to your question 

15 would be pollution. If you farm -- farm? -- any 

16 water near an industrial area will have issues. 

17 So, these farms are not near industrial areas, 

18 right? They are out in eastern Indonesia, 

19 pristine areas.

20 Now, biologically, algae I recall are 

21 able to pick up various things in the water. You 

22 know, you call it pollution.
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1 MEMBER SEITZ: Uh-hum.

2 MR. ASK: When it comes to nutrients, 

3 they can only pick up nitrate, nitrite, ammonia, 

4 phosphorous in the form of phosphate. So, we can 

5 say that.

6 Then, at the factory when we are 

7 extracting, we extract the carrageenan. All 

8 right? So, you have said, what's in it and what's 

9 coming out of it, I guess?

10 MEMBER SEITZ: Yes. I mean, I would 

11 imagine if there were pollutants in the water, 

12 ambient, that there could possibly be an uptake and 

13 possibly be transmitted.

14 MR. ASK: Yes. Right.

15 MEMBER SEITZ: I know I am asking that 

16 without any strong background in this area.

17 MR. ASK: Right. Yes.

18 MEMBER SEITZ: I am just trying to 

19 understand.

20 MR. ASK: Okay.

21 CHAIR FAVRE: Francis?

22 MEMBER THICKE: Of all the hemp that 
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1 has been grown, what percentage is used to make 

2 carrageenan?

3 MR. ASK: So, what you are saying is, 

4 what percentage of all the carrageenan seaweed 

5 consumed is --

6 MEMBER THICKE: Is that all this 

7 hemp -- I'm sorry, did I say "hemp"? I was talking 

8 about hemp earlier.

9 Of all of this seaweed, what percent is 

10 used to make carrageenan? Is it all used to make 

11 carrageenan?

12 MR. ASK: Okay. Do you mean all farmed 

13 seaweed in the world or are you talking about all 

14 seaweed --

15 MEMBER THICKE: That you're talking 

16 about, that you mentioned on your slides about. Is 

17 it 13,000 farms or --

18 MR. ASK: Yes, 33,000.

19 MEMBER THICKE: Thirty-three 

20 thousand.

21 MR. ASK: Over 33,000 farming farm 

22 families --
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1 MEMBER THICKE: Yes.

2 MR. ASK: -- of carrageenan seaweed.

3 MEMBER THICKE: Of carrageenan?

4 MR. ASK: So, that is 100 percent would 

5 be the answer to your question.

6 MEMBER THICKE: Thank you.

7 CHAIR FAVRE: Thank you very much.

8 MR. ASK: Okay.

9 CHAIR FAVRE: You missed my speech 

10 about keeping our questions brief. So, I will let 

11 you slide on this one.

12 (Laughter.)

13 Go ahead. We'll catch you the next 

14 time. It's all right.

15 Thank you.

16 Sorry, we didn't mean to make it 

17 distracting.

18 Next up is Bill Blakemore, with Jackie 

19 DeMinter on deck.

20 MR. BLAKEMORE: Yes, my name is Bill 

21 Blakemore. I'm the President of Celtic Colloids, 

22 Inc., an independent hydrocolloid technology 
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1 consultant. I have been a carrageenan chemist for 

2 more than 50 years.

3 I'm supporting the listing of 

4 carrageenan as a nonsynthetic, continued. No new 

5 molecular structures are created when carrageenan 

6 is extracted in alkaline. When it is extracted in 

7 alkaline to preserve the quality, the molecular 

8 weight, there's not structural components that are 

9 eliminated. There's no changes in molecular 

10 weight. There are minor changes in the ratio of 

11 the components, as I will show you on the next 

12 slide.

13 If you look at the top one there, it is 

14 commercial kappa carrageenan. It is a copolymer 

15 of ideal kappa carrageenan and ideal new 

16 carrageenan. Those are the two structures that 

17 you will see to the left of that.

18 Then, on a ratio of somewhere between 

19 75 and 25 and 95 to 5, depending on the plant enzyme 

20 activity or alkaline extraction, so the alkaline 

21 extraction does the same as the plant does with its 

22 enzymes.
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1 Carrageenan does not contain 

2 poligeenan. Here is a molecular weight profile of 

3 carrageenan, which is the brown bell-shaped curve. 

4 If you look at the left end of that curve, you will 

5 see molecules at 30,000 daltons. And if you look 

6 at the righthand end, you'll see molecules up at 

7 4 million. That is a definition of 

8 polydispersity. That is what the plant is 

9 growing. You are going to have all these molecules 

10 present as carrageenan.

11 If you look at the 50,000-dalton line, 

12 you will see that little triangle to the left of 

13 it under the curve, that is your low molecular 

14 weight tail, your percent below 50,000 daltons, and

15 it is expressed as that area over the total area.

16 If you look further to the left, I have 

17 put in there where poligeenan is. It is 10 to 20 

18 thousand daltons. A typical poligeenan will have 

19 95 percent of the molecules less than 20,000 

20 daltons and 50 percent below 10,000 daltons. So, 

21 there is no poligeenan in carrageenan. And note 

22 that the LMT is not poligeenan; it is carrageenan.
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1 (Timer rings.)

2 What? That can't be.

3 CHAIR FAVRE: Those three minutes go 

4 really fast, don't they?

5 Any questions?

6 MEMBER BEHAR: Do you know how many 

7 tons -- or I'm sure many, many, many tons -- of 

8 carrageenan are harvested worldwide?

9 MR. BLAKEMORE: It's tons of seaweed.

10 MEMBER BEHAR: For seaweed.

11 MR. BLAKEMORE: Not off the top of my 

12 head. That would have been a good question for the 

13 last speaker.

14 CHAIR FAVRE: Let me ask you, on that 

15 previous slide with the bell curve, you are saying 

16 that even when carrageenan degrades, it never 

17 degrades into the zone where it would be considered 

18 poligeenan? Is that what you are saying?

19 MR. BLAKEMORE: It doesn't degrade in 

20 the gastrointestinal tract. It can't. I mean, 

21 poligeenan is made by when you take carrageenan and 

22 boil it up in acid for six hours. You're not going 
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1 to find those conditions in the body. So, it is 

2 not going to degrade in the gut.

3 And most of its use, it is complex with 

4 protein at very low concentrations. Now, when 

5 that protein hits the acid environment in the 

6 stomach, it precipitates. It is below the 

7 isoelectric point of the protein. So, it proceeds 

8 until it is well down the gut. And when it is in 

9 there in the alkaline gut, it is perfectly stable.

10 Also, it is not going to interfere with 

11 protein digestion because you've got a few hundred 

12 parts per million of carrageenan and 3, 4, 5, or 

13 6 percent protein. That is not going to interfere 

14 with the digestion of the protein.

15 And there are papers -- and you will see 

16 I have referenced that in my letter to you -- that 

17 show that carrageenan is excreted intact.

18 CHAIR FAVRE: Okay. Thank you very 

19 much.

20 Any other questions?

21 Jean?

22 MEMBER RICHARDSON: Have you submitted 
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1 all of the PowerPoint that you have today? Has 

2 that been submitted as written comment?

3 MR. BLAKEMORE: Yes, you have it. 

4 You have it right here.

5 MEMBER RICHARDSON: Okay. Good.

6 MR. BLAKEMORE: And I have covered most 

7 of it in my letter as well.

8 MEMBER RICHARDSON: Yes, that's what I 

9 thought.

10 Thank you.

11 CHAIR FAVRE: Thank you very much for 

12 your comments.

13 MR. BLAKEMORE: Thanks.

14 CHAIR FAVRE: Next up is Jackie 

15 DeMinter, with Nina Mahmoudpour on deck.

16 MS. DeMINTER: Hello. My name is 

17 Jackie DeMinter. I'm the Certification Policy 

18 Manager at MOSA.

19 We currently certify approximately 

20 1700 clients. We also have extensive experience 

21 with reviewing inputs and maintain an internal 

22 materials review database which includes almost 
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1 6,000 brand-name products and generic materials.

2 We submitted nine letters and one 

3 informational chart addressing several topics. I 

4 will summarize some of our comment here.

5 EPA lists four inerts. Last fall we 

6 supported the annotation change for inerts which 

7 gave references to updated modernized lists. It 

8 is clear that the NOSB has agreed there needs to 

9 be a phaseout of MPE use in organic pesticide 

10 formulations. MPEs are not included on the 

11 proposed list. Thus, the direction here feels 

12 unnecessary if that proposal is acted upon.

13 To enable a less-burdensome transition 

14 to the new list, it seems transparent to compare 

15 advertise and educate. We don't have an opinion 

16 on how long it would take the pesticide industry 

17 to reformulate or how difficult that may be. But 

18 we do know that the conversation is being heard, 

19 and we know that it is being heard in the livestock 

20 healthcare industry, too, even though excipients 

21 are not under current discussion. We have already 

22 been contacted by a few manufacturers regarding 
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1 replacement ingredients in their iodine products.

2 Parasiticides. Regarding fiber, we 

3 thought that the NOSB Subcommittee proposal was 

4 clear, but it became apparent during the webinar 

5 comments that there is some question regarding when 

6 the production of organic fiber happens. Is it 

7 when the fiber is harvested or when it begins to 

8 grow?

9 It was also apparent that there are 

10 significantly varying views on this topic. Most 

11 of those comments on the proposed origin of 

12 livestock rules suggested a transition allowance 

13 for fiber-producing animals and acknowledged that 

14 the fleece or wool is the product of management, 

15 such as the use of external parasiticides and feed 

16 consumed since the last shearing. We appreciate 

17 the inclusion of fiber-bearing animals in your 

18 considerations and just ask that you state your 

19 intentions clearly.

20 Ancillary substances. We appreciate 

21 the ongoing consideration of ancillaries and find 

22 that our previous concerns have been addressed. 
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1 We still do have some concern regarding the 

2 practicality of requiring more compliance 

3 verification.

4 In closing, we appreciate that the NOSB 

5 has taken up discussion of the annual onsite 

6 peer-evaluation component of personnel 

7 performance evaluations. We did submit written 

8 comments and can provide additional information, 

9 if needed. Our Director, Cori Skolaski, is 

10 available to answer any questions you may have on 

11 this topic.

12 We also want to thank the NOP for the 

13 new Livestock and Poultry Practices Proposed Rule. 

14 We certify over 800 clients with livestock. So, 

15 we are quickly gathering client information and 

16 data. We are looking forward to providing robust 

17 comments for consideration and would welcome an 

18 extension of the comment period.

19 Thank you all. We appreciate all of 

20 your hard work on all of these very important 

21 topics.

22 (Timer rings.)
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1 CHAIR FAVRE: Yes, good job.

2 Questions?

3 MEMBER RICHARDSON: Could I ask you a 

4 question? I was a bit confused by your comments 

5 on the webinar. There were some issues raised 

6 about the wool parasiticide use. I'm not sure 

7 exactly what the issues are, since there's no 

8 evidence that there's any parasiticides left in 

9 wool. Do you have some sort of proposed different 

10 language or have you submitted any proposed 

11 different language to help us in our deliberations?

12 MS. DeMINTER: We did not consider that 

13 it was unclear when the production of fiber was. 

14 And it seems like a couple of people on the webinar 

15 commented, is that when the wool or fiber begins 

16 to grown? Is that when the production starts? Or 

17 is it when it is actually sheared off of the animal? 

18 Is that the production?

19 MEMBER RICHARDSON: Do you have a 

20 recommendation?

21 MS. DeMINTER: Do I have a 

22 recommendation? I would just maybe suggest that, 
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1 if you mean when it is to be sheared off, that you 

2 state that in your proposal --

3 MEMBER RICHARDSON: Okay.

4 MS. DeMINTER: -- just to be real clear 

5 what that word means. When is the production? As 

6 a certifier, we just want to enforce the rule that 

7 is put forth and be able to enforce it without any 

8 question or confusion in our community. So, just 

9 clarifying.

10 MEMBER RICHARDSON: Thank you.

11 CHAIR FAVRE: Thank you very much.

12 Next up is Nina Mahmoudpour, followed 

13 by Alexis Randolph on deck.

14 MS. MAHMOUDPOUR: Hello. Thank you 

15 for having me. My name is Nina Mahmoudpour. I am 

16 a first-year law student at Georgetown and have 

17 been passionate about organics and a member of the 

18 Cornucopia Institute for the last five years.

19 I care about preserving the integrity 

20 of organic food and disagree with the idea of 

21 companies making profits off the organic label 

22 without fully adhering to both the spirit and 
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1 letter of the law of the Organic Food Productions 

2 Act. This hurts organic farmers who do adhere to 

3 the law.

4 I am also passionate about access to 

5 organic foods in lower socioeconomic 

6 neighborhoods. While obtaining my undergraduate 

7 degree in Richmond, Virginia, I was involved with 

8 quality food access and elimination of food deserts 

9 in my area. At Georgetown, I am part of the 

10 Georgetown Food Co-op, which is set to take off this 

11 summer.

12 Public participation has always been 

13 the hallmark of the NOSB process and contributes 

14 to the label's integrity. I'm told that when 

15 Cornucopia representatives like myself first 

16 started attending meetings, each citizen could 

17 have up to five minutes with an additional 

18 five-minute proxy. Now expert staff might travel 

19 across the country for just three minutes to 

20 express all of their constituents' views.

21 Additionally, to increase public 

22 involvement, the NOP should get the agenda out 
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1 earlier, much earlier. The compressed time 

2 schedule was made even worse at this meeting 

3 because the official materials were posted a week 

4 later than usual, making it challenging for 

5 multiple Cornucopia staff members to review all of 

6 the public comments before this meeting. How 

7 could a volunteer NOSB member, then, possibly 

8 review and analyze all of the public comments?

9 Also, the NOSB asked, and the NOP 

10 committed to, creating an open docket so that 

11 materials could be shared throughout the year, 

12 lessening the strain prior to each meeting. The 

13 NOP should create the open docket they committed 

14 to.

15 Finally, we particularly object to 

16 information the NOP is currently concealing. 

17 Making NOSB applications public would allow the 

18 community to help the Secretary pick the best and 

19 brightest, and it might have prevented the kind of 

20 lawsuit that is pending now, challenging legally 

21 unqualified Board members.

22 Through the Freedom of Information Act, 
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1 the Cornucopia Institute has had to sue the USDA 

2 to secure the identities of scientists who are 

3 writing technical reviews.

4 Another Cornucopia lawsuit is now 

5 resulting in the release of enforcement data. Why 

6 are lawsuits necessary? This information belongs 

7 to the public. According to the Federal Advisory

8 Committee Act, all NOSB deliberative documents 

9 should be available.

10 I thank you for volunteering your time 

11 to make the USDA organic label better and listening 

12 to my comments. Thank you.

13 CHAIR FAVRE: Thank you very much.

14 Next up is Alexis Randolph, with Lauren 

15 Berlekamp on deck.

16 MS. RANDOLPH: Hi. Good afternoon. 

17 My name is Alexis Randolph, and I'm from Quality 

18 Assurance International. I have worked as a 

19 certifier for 18 years.

20 We certify over 1600 operators in the 

21 U.S., Mexico, Taiwan, Japan, and Canada, and are 

22 one of the leading providers of certification for 
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1 retail products.

2 First, I would like to address the 2018 

3 sunset materials for handling. I have prepared a 

4 list of materials, number of operators using each 

5 substance, and organic products produced, which I 

6 am turning in today with my public comments. Keep 

7 in mind that each operator represents dozens of 

8 currently-certified products in compliance with 

9 the NOP.

10 Please read our full comments because 

11 I am addressing just a few materials orally today.

12 Agar-agar. Six QAI-certified 

13 operators are using this material in yogurt, gummy 

14 candies, mints, and confections.

15 Regarding the question of essentiality 

16 compared to other gums, QAI cannot speak to the 

17 technical essentiality. So, we refer to our past 

18 comments regarding tragacanth gum. Operators 

19 have expressed the need for a variety of similar 

20 ingredients to make their product formulas unique 

21 and competitive in the marketplace.

22 Silicon dioxide. Five operators are 
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1 using organic rice hulls. Forty are using silicon 

2 dioxide as a defoamer and as a processing aid for 

3 products, including spices, tablets, and sake.

4 Because silicon dioxide is on the 

5 National List, a commonly-used defoamer is now 

6 certified organic using organic oils and other 

7 allowed ingredients. QAI saw operators change to 

8 organic rice hulls when those commercial 

9 availability requirements were implemented. 

10 However, when their product was further added as 

11 an ingredient into another product, the finished 

12 product quality was severely impacted. Operators 

13 switched back to silicon dioxide.

14 Cellulose. There is a suggestion for 

15 including the word "powdered" in the annotation. 

16 However, cellulose casing specification sheets 

17 indicate it is made from powder and pulp.

18 Regarding your question about whether 

19 ancillary substances listed in the TR are used in 

20 cellulose, yes, they are.

21 Tartaric acid is used in organic 

22 flavors, beverages, baked goods, and sweeteners. 
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1 It is often used for making organic invert sugar, 

2 a widely-used organic sweetener.

3 Regarding the seed purity discussion 

4 paper, we support the intention of the Board, and 

5 my colleague already commented on this topic. I 

6 would just like to add that QAI agrees with the OTA 

7 comments that the NOP guidance on seed requirements 

8 could go further to push organic operators to 

9 overcome barriers for using organic seed when 

10 available. QAI would like to see organic farmers 

11 be required to conduct seed trials with organic 

12 seed when quality or agronomic conditions are one 

13 of the barriers.

14 Lastly, I would like to show support for 

15 a future endeavor of revising the regulation 

16 regarding excluded operations. We feel it is 

17 imperative to require all importers, brokers, and 

18 distributors of product to be certified in order 

19 to reduce the risk of fraud.

20 I'm happy to answer any questions. 

21 Thank you.

22 (Timer rings.)
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1 CHAIR FAVRE: You guys are doing a 

2 great job.

3 Zea?

4 MEMBER SONNABEND: Thank you, Alexis.

5 Our favorite subject here. You list 

6 carrageenan uses as "spices in gel format (liquid 

7 rub)". Could you just explain what that is, 

8 because that is a use we haven't had submitted 

9 before?

10 MS. RANDOLPH: Yes. So, I can only 

11 best equate it to perhaps a rub you would use on 

12 a product that you had to barbeque, like chicken 

13 or beef.

14 MEMBER SONNABEND: And someone puts 

15 like garlic or oregano on that and --

16 MS. RANDOLPH: Like garlic and 

17 oregano.

18 MEMBER SONNABEND: -- to hold it in 

19 suspension, that is what the carrageenan is used 

20 for?

21 MS. RANDOLPH: Yes, apparently, that 

22 is the use of carrageenan. It is predominantly 
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1 organic spices, and carrageenan somehow serves a 

2 purpose in this gel format.

3 MEMBER SONNABEND: Okay. Thank you.

4 CHAIR FAVRE: Thank you very much.

5 MS. RANDOLPH: Thank you.

6 CHAIR FAVRE: Next up is Lauren 

7 Berlekamp, followed by David Will on deck.

8 MS. BERLEKAMP: Thank you for the 

9 opportunity. I'm Lauren Berlekamp, here to speak 

10 on behalf of the Hemp Industries Association.

11 Industrial hemp is an agricultural 

12 commodity that is cultivated for use in the 

13 production of a wide range of products, including 

14 foods and beverages, cosmetics and personal care 

15 products, and nutritional supplements, as well as 

16 fabrics, textiles, paper, construction, 

17 insulation materials, and other manufactured 

18 goods. Hemp can be grown as fiber, seed, and other 

19 dual-purpose crops.

20 Congress added Section 7606 to the 2014 

21 farm bill which defines industrial hemp as distinct 

22 from marijuana and authorizes legal hemp research 
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1 in pilot programs by universities and state 

2 departments of agriculture.

3 In 2015, states, including Colorado, 

4 Kentucky, Oregon, and Tennessee, authorized hemp 

5 pilot programs conducted by farmers, and more than 

6 3900 acres of hemp were harvested.

7 The USDA has been certifying hemp 

8 organic from Canada, Europe, and China under the 

9 National Organic Program for more than 15 years. 

10 Hemp and seed fiber is 100 percent legal to import 

11 and sell in the U.S., and legal USDA-certified 

12 organic hemp foods and supplements are sold by 

13 thousands of U.S. retailers.

14 Hemp is the fastest-growing consumer 

15 category in the natural products industry, and the 

16 demand is overwhelmingly for organic. Seven USDA 

17 organic certifications had already been issued for 

18 legal domestically-produced hemp. However, on 

19 February 16th, 2016, the USDA released an 

20 instruction to the NOP certifiers to stop issuing 

21 certifications for industrial hemp crops in the 

22 U.S. based on its yet undetermined legal status.
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1 As these pilot programs are conducting 

2 research on the economic viability of 

3 domestically-produced hemp, U.S. farmers should 

4 not be discriminated against by the NOP's own 

5 standards, and they ought to be able to distinguish 

6 their value-added hemp products as organic in order 

7 to gain consumer confidence to demonstrate that 

8 viability and to be competitive with imported 

9 USDA-organic-certified hemp products.

10 The legality of hemp pilot programs is 

11 clear under Section 7606. The legality of hemp 

12 seed and fiber is clear under 21 USC 802.16, and 

13 it is a fact that the USDA currently allows 

14 certification of hemp through the NOP, and has for 

15 at least 15 years.

16 Thus, the Hemp Industries Association 

17 respectfully requests on behalf of its 566 members 

18 that the National Organic Standards Board take a 

19 position in favor of allowing organic 

20 certification of U.S. hemp crops grown under 

21 Section 7606 and recommend to the USDA that it move 

22 forward on organic certifications of hemp through 
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1 the NOP.

2 Members of Vote Hemp, the National Hemp 

3 Association, and the general public have also 

4 signed a petition making this request, which was 

5 submitted as public comment to the NOSB.

6 Thank you for your time and 

7 consideration.

8 CHAIR FAVRE: Thank you.

9 Questions?

10 (No response.)

11 Thank you very much.

12 MS. BERLEKAMP: Thank you.

13 CHAIR FAVRE: Next up is David Will, 

14 followed by Bill Wolf on deck.

15 MR. WILL: Good afternoon. I wanted 

16 to thank the Board very much for the few moments 

17 that we have in order to address you.

18 My name is David Will. I'm with a 

19 southern California organic egg produce, and my 

20 comments are in relation to my involvement with the 

21 Methionine Task Force.

22 The Task Force represents about 70 
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1 percent of the broiler industry, and we represent 

2 about 9 million of the organic laying hens in the 

3 United States, covering from large producers all 

4 the way down to several hundred small family farms.

5 We wanted to come and just give you a 

6 brief update because our industry has been bagged 

7 and complained about that. We have not come and 

8 given you regular updates and have not participated 

9 fully in this in the past. So, we want to make sure 

10 we at least give you any news that we have on a 

11 somewhat regular basis.

12 The next thing for our group is that we 

13 are going through and going to be doing a rather 

14 large fundraising opportunity because we are going 

15 out and soliciting research from several 

16 universities in order to look at some of the options 

17 and methionine sources that have been identified.

18 We are currently working with North 

19 Carolina State and Penn State, two professors 

20 there. They have also published several 

21 literatures that you can find.

22 A couple of things that we have looked 
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1 at, which was, first, egg whites. It is kind of 

2 problematic with a vegetarian claim on our label.

3 One that we are very excited about and 

4 had some good initial luck with was Brazil nuts. 

5 However, the selenium content of Brazil nuts will 

6 make it practically impossible to get through 

7 AAFCO. That was our closest and best leading 

8 natural alternative at this time.

9 We are still investigating insects and 

10 working with AAFCO and the FDA to find out what we 

11 need to do to get those approved and what form they 

12 would be allowed, and, also, what sort of ration 

13 that would look like. In addition, we would have 

14 to do some sampling in consumer feedback panels and 

15 taste panels to see if that has any impact.

16 We have now had three studies that have 

17 looked at heirloom breed birds on the layer side 

18 of the industry, and all of them have come back with 

19 the same conclusion: that all heirloom breeds do 

20 require the same methionine requirement as the 

21 modern breed. So, we are pretty convinced that 

22 that issue is closed, and we are not going to make 
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1 longer looks into that.

2 And then, the last one is the 

3 high-protein corn. We have still had some issues 

4 with that of even having it available for small feed 

5 trials. Please know at this point in time all of 

6 our feed trials have been small in the last year, 

7 100 birds or so in very limited groups.

8 So, we are still looking at 

9 alternatives. We still have more that we are 

10 throwing on, and we are still looking and pursuing 

11 the insects.

12 And that's all. We just wanted to give 

13 you a brief update where we stand.

14 Thank you very much for all your time 

15 and effort and your hard work.

16 CHAIR FAVRE: Thank you very much.

17 Ashley?

18 MEMBER SWAFFAR: David, I just want to 

19 say thanks for coming and giving us an update on 

20 methionine. This is something that I think is 

21 important to the livestock community, to see that 

22 the poultry industry is moving forward.
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1 Do you have a paper with a summary of 

2 that that we could bring back to the Livestock 

3 Committee?

4 MR. WILL: Yes, I can put one together 

5 for you guys and, also, list of members and our 

6 fundraising goal for the next go-round.

7 MEMBER SWAFFAR: Yes, I think that 

8 would be really important for us, as a Committee, 

9 to kind of understand you a little better.

10 MR. WILL: Sure.

11 MEMBER SWAFFAR: Thank you.

12 MR. WILL: Thank you.

13 CHAIR FAVRE: Thank you very much.

14 Next up is Bill Wolf, with Laura Batcha 

15 on deck.

16 MR. WOLF: Okay. Wow, almost last.

17 Welcome, new members.

18 I'm Bill Wolf with Wolf DiMatteo & 

19 Associates. We have submitted numerous written 

20 comments, some of which are on the slide on the wall 

21 now. But today I come in person to praise your work 

22 and to share some history.
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1 NOP is the most public and transparent 

2 rule in the world. Organic is the only standard 

3 that bridges all crops, animals, and climates, and 

4 it is the strictest and most complex review of ag 

5 and food in all of history. We are making a 

6 difference and we should unite to stand proud and 

7 stand tall.

8 But decisions can be difficult when 

9 converting a philosophy into regulations. As a 

10 farmer, researcher, supplier, and consultant for 

11 45 years, I have been seeking best organic 

12 practices and products.

13 When establishing allowed materials 

14 lists over the last 30 years, we faced the question, 

15 what tools are really necessary and useful in 

16 organic systems? From this history, I ask you to 

17 consider the following four principles during your 

18 deliberations:

19 One, don't make shrinking the list a 

20 goal. Vote based on encouraging organic as a 

21 production and processing method.

22 This list is not a popularity contest 
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1 of how many comments were for or against a material. 

2 You also represent the silent and the future, and 

3 it is not about public misconceptions or even 

4 potential allergens.

5 Three, consider a respect for the work 

6 and deliberations of past NOSB votes. We can't 

7 constantly reinvent the wheel.

8 Four, weigh the criteria in the Organic 

9 Foods Production Act and the regs and, then, decide 

10 if it may help increase acreage, earthworms, and 

11 planetary health.

12 Thank you for your extraordinary work 

13 to advance organic and sustainable agriculture. 

14 Keep up the good work. And most important, have 

15 fun and make a difference in this process.

16 Thank you.

17 CHAIR FAVRE: Thank you.

18 Any questions?

19 (Applause.)

20 Tom?

21 VICE CHAIR CHAPMAN: Bill, you have 

22 been involved in this industry for a long time, in 
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1 this community. Can you give us some perspective 

2 on where you see standards are today versus 20 years 

3 ago?

4 MR. WOLF: It is much more disciplined. 

5 I mean, the summary would be far more clear, 

6 transparent, and far more strict.

7 I actually helped and worked with a 

8 number of certifiers on their decisions, and there 

9 were differences between the different certifiers 

10 in that era, even than there is today, in fact. And 

11 there is still work being done to align the 

12 interpretations of the current National Organic 

13 Program rules and worldwide alignments as well.

14 The fundamentals are that there is a 

15 uniform methodology for reviewing things, but, 

16 most importantly, there are many materials that we 

17 used to allow and are no longer allowed. The 

18 actual list of tools that are available, both to 

19 farmers and in processing over the last 20 years, 

20 has become much tighter. And yet, the 

21 communication to the public is that it has become 

22 weaker. This standard is actually tighter today 
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1 than it was 20 years ago or 10 years ago or 5 years 

2 ago or 2 years ago.

3 CHAIR FAVRE: Thank you very much.

4 MR. WOLF: Sure.

5 CHAIR FAVRE: Next up is Laura Batcha, 

6 followed by Dick Siegel on deck.

7 MS. BATCHA: Hi, everyone. I'm Laura 

8 Batcha. I'm the Executive Director of the Organic 

9 Trade Association. We are a member-based business 

10 association.

11 And the resource booklet that we put 

12 together has some great information about our 

13 membership, our governance, our decisionmaking 

14 processes, beginning on page 50. So, if you don't 

15 know much about us, I encourage you to take a look 

16 there.

17 I wanted to speak to you today primarily 

18 about the seed purity discussion document, but I 

19 want to take a moment, reluctantly, first, to 

20 correct some inaccurate information that was 

21 shared from the podium yesterday.

22 And I say "reluctantly" because the 
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1 Trade Association and I personally do trust the 

2 Board as individuals to be able to sift through what 

3 you hear from the podium in a couple of long days 

4 of public comment. The challenge is that we do 

5 have a transcript of the records and statements 

6 become a record in the transcript. And these 

7 transcripts have a way of coming back five years 

8 later, when there is a new set of volunteer Board 

9 members or in court cases that we might not have 

10 been anticipating. So, indulge me just for a 

11 moment.

12 You heard a few things yesterday 

13 regarding the Organic Materials Review Institute, 

14 and my colleagues John Ashby and Peggy Miars 

15 addressed those concerns. So, I won't go into that 

16 in detail.

17 You did hear some statements that have 

18 been made from the podium before regarding the 

19 Organic Trade Association's nonprofit arm 

20 conducting technical reviews under contract for 

21 the National Organic Program. The Organic Trade 

22 Association does administer a 501(c)(3) research 
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1 organization called the Organic Center, and we have 

2 administered that organization for a number of 

3 years.

4 Prior to our administration of the 

5 organization, it was an independent nonprofit. 

6 Part of the terms and conditions for the Organic 

7 Trade Association taking over the administration 

8 of that organization was to, first, cancel the 

9 contract with NOP for the conducting of the 

10 technical reviews. That was a requirement of the 

11 terms and conditions of assuming responsibility 

12 for the nonprofit that was made by the Trade 

13 Association. I know because I wrote the letter and 

14 I made the call myself to NOP prior to signing off 

15 on this deal with the other organization, because 

16 we really didn't feel like it was our role to be 

17 involved in technical reviews. So, I just want to 

18 make it clear to folks that that is the accurate 

19 record on that.

20 And then, the third thing I want to 

21 address is I would encourage the National Organic 

22 Program to address again for the transcript 
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1 allegations regarding uninvestigated complaints. 

2 I think we all invest a lot in oversight on this 

3 program, and I would hate for the public or future 

4 individuals to look at those transcripts and see 

5 those allegations go unanswered.

6 On the seed purity document, we really 

7 support the Seed Purity Advisory Task Force. I 

8 serve on a separate FACA committee called AC21. We 

9 are charged with advising the Secretary on issues 

10 related to coexistence. Right now, we are working 

11 on a mandate that has to do with recommendations 

12 to develop joint coexistence plans between 

13 organic, identity-preserved, and conventionally 

14 GMO agriculture to be --

15 (Timer rings.)

16 I'm happy to answer questions about 

17 that, if you are interested in what we are doing 

18 and how your work may impact that.

19 CHAIR FAVRE: Zea?

20 MEMBER SONNABEND: How could AC21 work 

21 with our efforts about GMOs?

22 MS. BATCHA: Thanks, Zea.
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1 So, as we have been working on our 

2 recommendations, one of the first things that I did 

3 was share with the AC21 Advisory Committee the work 

4 you all did to pass the recommendation, the 

5 guidance recommendation, on contamination 

6 prevention practices. And that helped serve as a 

7 model for, first, educating my colleagues about all 

8 the things organic farmers are already doing and 

9 continue to strive to do. And it is helping shape 

10 some of the side-by-side formats for these joint, 

11 coexistence templates.

12 The place that we are really challenged 

13 in our work is there is a range of views on that 

14 Committee as to the importance of seed purity in 

15 a joint, coexistence plan. So, there has been a 

16 reluctance to take on the idea that, if you are 

17 working with your neighbor on preventing 

18 cross-pollination, if nobody knows what you are 

19 starting with for seed, all of your efforts might 

20 be for naught. And this is a real sticking point 

21 on us getting anywhere with the recommendations.

22 So, I am looking for support from this 
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1 Board to help bolster that case and to help USDA 

2 get involved in it because the providers of the 

3 technology are not going to release those purity 

4 standards freely and willingly without some good 

5 leadership and courage on the part of the 

6 Department and the community.

7 CHAIR FAVRE: Tom?

8 VICE CHAIR CHAPMAN: So, in supporting 

9 the NOSB's work, the NOP funds the technical 

10 reviews we get as well as some of the other advice 

11 that comes through us through technical reviews, 

12 technical panels like we have here. That is 

13 outside of the FACA funding.

14 And so, in general, I would say greater 

15 funding for the NOP would, then, in turn, support 

16 the NOSB's functionings as a Board. Can you speak 

17 to OTA's efforts on funding the NOP?

18 MS. BATCHA: Yes, happy to. I think I 

19 would first start by saying, in this unique 

20 public/private partnership we expect a lot of 

21 response, rightly so, from our government in 

22 regards to organic. It has to do with the work of 
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1 the NOSB, the technical reviews, the expert panels 

2 that we convene, but it also extends beyond that.

3 We have expectations for the program on 

4 robust investigation of complaints, accreditation 

5 oversight, making sure the certifiers and 

6 inspectors are all trained up and educated, 

7 overseeing a global program and new approval 

8 arrangements. So, it is a lot of expectation. We 

9 actually like to hold the program accountable for 

10 our expectations.

11 The farm bill in 2014 authorized 

12 funding for the National Organic Program at $15 

13 million a year. Since sequestration about, I 

14 think, maybe 2009 -- somebody might correct me on 

15 that year, '08, '09, '10, something in there -- the 

16 program got a bump-up in their annual 

17 appropriations to about $9.1 million. It has been 

18 flat-funded since then.

19 We advocate for that every year, and I 

20 will, quite frankly, say we have been a little bit 

21 challenged by getting the community to speak with 

22 one voice about supporting resources for NOP to do 
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1 all the things we demand they do. So, we hope that 

2 our colleagues in the community will continue and 

3 join us in that effort.

4 CHAIR FAVRE: Thank you very much.

5 MS. BATCHA: Thank you.

6 CHAIR FAVRE: Our final commenter 

7 today will be Dick Siegel.

8 MR. SIEGEL: Good afternoon. I'll try 

9 to be very brief because this is a rather narrow 

10 technical point that I am going to comment on.

11 My name is Richard Siegel. I'm an 

12 attorney in Washington, D.C., and my specialty is 

13 the National Organic Program. I have been in this 

14 specialty for more than 10 years.

15 My client today is Absorbent Products 

16 Limited in British Columbia, and my subject is 

17 three pending petitions before the Livestock 

18 Subcommittee. These are the petitions for 

19 aluminum sulfate, sodium bisulfate, and 

20 acid-activated bentonite. And there are 

21 technical evaluation reports that have been posted 

22 for all three of these petitions. The Committee 
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1 is about to act on them.

2 These are all synthetic substances, and 

3 they are all intended to do the same thing; i.e., 

4 control ammonia in poultry houses. My client, 

5 Absorbent Products, makes a natural product that 

6 is OMRI-listed called Activated Barn Fresh. And 

7 Activated Barn Fresh does the same thing that these 

8 synthetic products do that are being petitioned. 

9 So, this accounts for our interest in these three 

10 petitions.

11 In looking at the three TRs, looking at 

12 them individually and collectively, we have noted 

13 certain gaps and inconsistencies in the TRs. We 

14 have prepared a memorandum, and this has now been 

15 entered into this meeting docket.

16 So, I ask the Livestock Subcommittee to 

17 take a look at our thoughts and observations, so 

18 that, as you look at the TRs, you could consider 

19 the possibility that there are gaps in the TRs that 

20 you should be aware of.

21 The gaps relate to sulfuric acid. All 

22 three materials involve sulfuric acid. We looked 
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1 in the TRs for a complete history of all the 

2 previous actions by this Board on sulfuric acid. 

3 We did not see a complete list. So, we have 

4 supplemented that in our memorandum.

5 The other inconsistency is that natural 

6 alternatives, including our product, Activated 

7 Barn Fresh, are treated not in a consistent way 

8 throughout the three TRs.

9 So, this is our sole reason for being 

10 here today, and I appreciate the staff for fitting 

11 us in.

12 And I also want to welcome the new 

13 members, many of whom I have known for a long time. 

14 I wish you all a successful run on the NOSB.

15 Thank you.

16 CHAIR FAVRE: Thank you very much.

17 Ashley?

18 MEMBER SWAFFAR: Hey, Dick, I just want 

19 to let you know I'm the lead on all three of those 

20 materials.

21 MR. SIEGEL: Yes.

22 MEMBER SWAFFAR: So, I would like to 
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1 have a conversation with you afterwards to get some 

2 more information on that product. We will be 

3 looking into the three letter amendments this 

4 summer.

5 MEMBER SWAFFAR: Yes, I understand 

6 that. Thank you very much.

7 CHAIR FAVRE: Thank you very much.

8 And with that, we are going to conclude 

9 the public comment section of our meeting this 

10 week.

11 Thank you all for participating. It 

12 helps us a lot on the Board to hear your 

13 perspectives.

14 The next item on our agenda is going to 

15 be the expert panel discussion on emerging 

16 technologies in agricultural biotechnology.

17 So, we will take a few minutes to allow 

18 our panelists to get up here. I urge you not to 

19 leave the room if you want to be here for the start 

20 of it. And I ask the Board members to not leave 

21 because we are going to try to get started with this 

22 as quickly as possible.
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1 Thank you.

2 (Whereupon, the foregoing matter went off the record at 1:54 p.m. and 

3 went back on the record at 1:57 p.m.)

4 CHAIR FAVRE: I would like to turn this over to Lisa de Lima to 

5 introduce our panel. Lisa is the Chair of the Materials Subcommittee.

6 MEMBER DE LIMA: Thank you, Tracy.

7 Before I get started with 

8 introductions, I think Tom has something he wants 

9 to say to the Board.

10 VICE CHAIR CHAPMAN: Yes. We just 

11 wanted to disclose for the public record and for 

12 transparency something that myself and my company 

13 are actually quite proud of, but that Professor 

14 Tracy is endowed Chair funded by the Clif Bar Family 

15 Foundation and Organic Valley. And I work for Clif 

16 Bar.

17 Thank you.

18 MEMBER DE LIMA: All right. So, I am 

19 going to go ahead and give an introduction for each 

20 of our panelists. Then, we are going to proceed 

21 through each of their presentations. And then, at 

22 the end, we will have some time for questions from 
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1 the Board.

2 All right. So, Dr. Ralph Scorza is a 

3 research horticulturist and lead scientist for the 

4 Genetic Improvement of Fruit Crops Research Unit 

5 of the USDA-ARS, Appalachian Fruit Research 

6 Station in West Virginia.

7 He received his BS and MS degrees in 

8 agronomy and plant physiology from the University 

9 of Florida and received his PhD in plant genetics 

10 and breeding from Purdue.

11 He and his USDA colleagues developed 

12 the FasTrack Program for Accelerated Fruit Tree 

13 Breeding and is a Fellow at the American Society 

14 for Horticultural Science.

15 Dr. Bill Tracy is the Clif Bar Family 

16 Foundation and Organic Valley Professor of Organic 

17 Plant Breeding and the Chair of the Department of 

18 Agronomy at UW-Madison.

19 He received his BS and MS degrees in 

20 plant and soil science from the University of 

21 Massachusetts-Amhurst and a PhD in plant breeding 

22 from Cornell University.
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1 Dr. Tracy's research is on sweet corn 

2 improvement, and he has been active in the Seeds 

3 and Breeds Group, and is Chair of the Maize, Corn, 

4 Germplasm Committee.

5 Dr. Michael Hansen is the Senior Staff 

6 Scientist with Consumers Union, the publisher of 

7 Consumer Reports. He has been largely responsible 

8 for developing Consumers Union's position on 

9 safety, testing, and labeling of 

10 genetically-engineered foods.

11 Dr. Hansen served on the USDA Advisory 

12 Committee on Agricultural Biotechnology and on the 

13 California Department of Food and Agriculture Food 

14 Biotechnology Advisory Committee.

15 He received his doctorate in ecology 

16 and evolutionary biology from the University of 

17 Michigan and did his post-grad study on the impacts 

18 of biotech on agricultural research.

19 And lastly, we have Dr. David Gould, 

20 currently serving as the Program Facilitator for 

21 IFOAM, Organics International, and is their lead 

22 on developing a revised position on genetic 
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1 engineering and breeding techniques.

2 In that role, he has coordinated a 

3 global consultation on GE and chairs the IFOAM 

4 Working Group on Breeding Techniques. He has 

5 served on the OMRI Advisory Counsel and as an 

6 advisor and in other technical roles to the Non-GMO 

7 Project.

8 He has a degree in life sciences from 

9 MIT.

10 So, I want to thank you all for being 

11 here, and we are going to go ahead and start with 

12 Dr. Gould.

13 DR. GOULD: Thanks very much for having 

14 me here and for allowing me to speak for the 

15 position of IFOAM, Organics International. We 

16 are, as the umbrella organization for the organic 

17 movement worldwide, very glad to be able to 

18 contribute to this discussion and, both now and in 

19 going forward, to help facilitate a global 

20 harmonized discussion.

21 When I read the NOSB work on this, I was 

22 really pleased. You have made my job actually 
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1 quite a bit easier because of the excellent quality 

2 of it. And technically speaking, I don't 

3 necessarily have a lot of criticism or critique or 

4 differences. I can highlight a few things in my 

5 comments, but I want to acknowledge the good and 

6 thorough that is being done. It is largely in 

7 concert with the kinds of thoughts and discussions 

8 that have been going on in other parts of the world. 

9 You have relied on the FiBL dossier as well.

10 One thing I did not see mentioned was 

11 the ECO-PB position paper, the European Consortium 

12 on Organic Plant Breeding, which I would also 

13 recommend as a very valuable resource. I would be 

14 glad to share that going forward.

15 And I think this is a strong discussion. 

16 I know, from talking with Zea and a few others 

17 earlier, that there is a timeline pressing to take 

18 some action and make a decision on this proposal. 

19 We would hope that there could be some more 

20 international harmonization and, by that, I would 

21 also mean now synchronization of the discussions 

22 to make sure that the kinds of decisions that are 
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1 being taken here can be acceptable and 

2 mutually-agreeable with other parts of the world.

3 The most active place on the discussion 

4 is in the European Union. In reality, the European 

5 Union has postponed its legal interpretation until 

6 the end of 2016, due to a variety of considerations. 

7 And they actually have not given much further 

8 specification on that. So, we do have a little bit 

9 of time.

10 The IFOAM EU group, which is probably 

11 the most active group in the European Union on these 

12 kinds of issues, has put forth a position paper 

13 which is very much in line with what the NOSB has 

14 put out. And it is generally a precautionary 

15 approach to take all of these new technologies and, 

16 at least for the time-being, consider them all what 

17 would be considered here "excluded methods," as a 

18 way to protect the organic sector from these 

19 emerging technologies, some of which are clearly 

20 there is consensus about that they shouldn't be 

21 allowed and others where there might be some more 

22 discussion. But that is a stop-gap in a sense. 
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1 Our position is to be supportive of that position, 

2 but to also continue the discussion going forward.

3 With that, I would like to just make a 

4 comment about the broad picture. In my 20-plus 

5 years of working on this issue, I have never found 

6 anything as complicated as the GMO issue. It is 

7 getting more complicated. And really, what is 

8 happening now is we are entering a phase in humanity 

9 of genetic disruption that we have never seen 

10 before. The technology is growing fast. It is 

11 widely accessible.

12 One of the jobs that I do at IFOAM is 

13 I monitor the generic top-level internet domain 

14 .bio. We check for compatibility with the 

15 principles of organic agriculture. And I can tell 

16 you, just by screening those things, it is very 

17 readily apparent that the technology is very 

18 accessible and relatively cheap.

19 What we are heading toward is a 

20 situation in the future where there will be genetic 

21 mixing like we have never seen before. And as a 

22 movement and as a sector, as a market, we have been 
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1 chasing at the heels of a very rapidly-moving 

2 technology and we need to get out in front of it, 

3 prepare ourselves for a future where we have to be 

4 clear about what our guarantee is, what our message 

5 is, how we take our process-based approach, yet 

6 also meet consumer expectations for the quality and 

7 the content of foods.

8 You know, we are talking about 

9 technologies which are going to be much more 

10 difficult to detect. And even if they are 

11 detectable, what we are going to do with those 

12 results and who is going to actually pay for all 

13 of that testing, we cannot put that burden on 

14 organic producers or on the organic market. We 

15 need to probably come to grips with the fact that 

16 not every or any one lab is necessarily going to 

17 have all the technologies available to do that 

18 detection. And there may need to be some kind of 

19 cooperation.

20 But, even more so, this is not an issue 

21 which should be just left to the organic sector to 

22 fend for itself. This is a broader regulatory 
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1 issue for the common good, and we need to have 

2 better regulations about the release of these 

3 technologies. This is something that I would urge 

4 USDA to take on as a broader issue than just the 

5 National Organic Program. There needs to be a true 

6 accounting for liability that may be caused by the 

7 introductions of these technologies.

8 I think as far as criteria and 

9 definitions, that the two of those must go 

10 together. We don't have any particular problem 

11 with the kinds of definitions that are being 

12 proposed right now by NOSB. I do think that there 

13 could be some wordsmithing going on in the future. 

14 But the criteria and the definitions must go 

15 together to ensure the common benefit for the 

16 organic sector.

17 One second, sorry, here.

18 I have been asked a few questions by the 

19 Board here. So, I think I have answered the 

20 question about how this fits with organic 

21 regulations and IFOAM.

22 There is a question about detection 
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1 technology. Technically, we don't have the real 

2 answer to that, except for what I have already told 

3 you.

4 As far as the terms in the chart, I can 

5 tell you about a few of the approaches that we have 

6 taken. One is on cell fusion, in particular, cell 

7 fusion within plant families. We have a motion 

8 from our General Assembly that was to try to develop 

9 a strategy for the replacement of varieties derived 

10 from cell fusion, including protoplast or 

11 cytoplast fusion that have had a presence in 

12 organic farming practices. Our idea is to develop 

13 some guidelines for the socioeconomic 

14 implementation of those strategies and to promote 

15 alternative breeding programs, one of the things 

16 that was to try to replace those kinds of varieties 

17 over time. Now, being able to trace back and find 

18 them is obviously a difficult and challenging 

19 endeavor, but we are determined to try to get toward 

20 that.

21 Some of the proposal also from NOSB 

22 mentions the possibility of having organic plant 
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1 breeding standards in the future as to what 

2 constitutes an organically-bred variety. We are 

3 in support of that and are considering similar 

4 things. And we would be very interested in 

5 collaborating on it.

6 In that vein, I would also say that our 

7 position is that there needs to be globally 

8 national bases or other types of collaborations, 

9 much more public funding put into the development 

10 of improved genetics through what would be 

11 acceptable methods.

12 I never really liked, I have to say, the 

13 "excluded methods" terminology, but now I think it 

14 may actually be one of our saving graces because 

15 we may be able to get past some of the 

16 micromanagement of definitions that some forces 

17 who would like to see us regulate these 

18 materials -- you know, use that as a loophole.

19 The only other thing I would say about 

20 what is in the chart is I can say something about 

21 the induced mutagenesis. Our position on those, 

22 whether it is induced mutagenesis or other types 
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1 of, shall we say, extracellular stimuli, are ones 

2 where we feel like we need to continue the 

3 discussion to get some better clarity on whether 

4 or not these meet the principles of organic 

5 agriculture, in particular, the precautionary 

6 principle. So, we support more discussion on 

7 those, the precautionary approach for the

8 meantime, and are happy to try to consider those 

9 TBD categories.

10 The only other part from the 

11 terminology chart that I think that I have seen in 

12 global discussions are things like embryo rescue 

13 from plants, which there is a considerable amount 

14 of interest in potentially considering those as 

15 compatible with organic.

16 The final piece, statement, that I will 

17 say right now is that we are also very concerned 

18 by the overall scope of genetic technology and the 

19 introduction of GMO insects and other kinds of 

20 things which are not mentioned in these plant 

21 breeding techniques, but that is something that we 

22 need to also take into consideration.
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1 So, I don't know how much time I have 

2 used, but I will stop there and wait for some 

3 questions later.

4 Thank you.

5 MEMBER DE LIMA: Thank you.

6 We are going to move on to the next 

7 panelist and save questions for the end.

8 So, Dr. Scorza?

9 DR. SCORZA: Well, thanks very much. 

10 I really appreciate being here and to be able to 

11 talk with this group and the Board about some of 

12 the work that we are doing.

13 I would like to just mention that I am 

14 a plant breeder. I have been a tree fruit breeder 

15 for the last 36 years. Most of my work, the 

16 varieties that we have developed have been 

17 conventional varieties of peaches, nectarines, and 

18 plums. We have done some genetic engineering.

19 What I would like to talk with you all 

20 about today is one of the techniques that is on your 

21 list of "To Be Decided". And that is FasTrack 

22 breeding. So, I would like to run through the 
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1 FasTrack breeding just give you an idea of why we 

2 are doing it, how we are doing it, and what we think 

3 the advantages of this technology might be.

4 So, FasTrack breeding. Okay, here we 

5 go. What is the problem? Why are we interested 

6 in this? Because, as I mentioned, most of my work 

7 has been conventional breeding, developing 

8 varieties through hybridization and selection, 

9 very traditional type of work.

10 But this is how the breeding program for 

11 tree fruits run: you can see the gentleman on the 

12 ladder there. We pollinate these flowers on 

13 trees. We pollinate literally hundreds of 

14 thousands of flowers. So, we have to strip all the 

15 male parts of the flower off, so the flower doesn't 

16 self-pollinate itself. And then, we apply the 

17 pollen from what will be the male parents. Now 

18 here is the female, and the male is the pollen. We 

19 do that for hundreds of thousands of flowers.

20 Many times in the spring we will get 

21 cold temperatures and we have to try to protect 

22 those pollinated flowers from frost. I can tell 
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1 you in the last five years we have had early spring 

2 warm-ups in the middle of March here in West 

3 Virginia, which is we are about an hour-and-a-half 

4 from D.C., west of D.C. So, we have had early 

5 warm-ups in mid-March and, then, we have had very 

6 severe frosts and we have lost many, many of our 

7 hybridizations.

8 So, then, the next step is we collect 

9 the fruit, extract the seed. We grow the seed in 

10 the greenhouse until the next spring and, then, we 

11 plant the trees out in the field.

12 Then, what we do is we wait three to four 

13 years to see the fruit that are produced. 

14 Meanwhile, we can be inspecting the trees for 

15 disease-resistance or other characteristics. We 

16 have to wait three to four years to see the fruit. 

17 So, that is the program that we run. What we have 

18 done, what we have pollinated this year, we won't 

19 see the fruit for three or four years from now.

20 The problem is that these trees have a 

21 long generation cycle. Then, to improve a trait, 

22 such as disease-resistance and combining 
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1 disease-resistance with fruit quality that will be 

2 accepted in the market, we have to go through many 

3 generations of breeding, and each generation 

4 taking three to four years. So, in practice, it 

5 takes 15 to 20 years to produce a new variety.

6 Now, if you are bringing in traits from 

7 a wild variety, so let's say disease-resistance but 

8 you have really poor fruit quality, making the 

9 fruit hardly edible because they may be very 

10 bitter, it takes many years of crossing that 

11 germplasm with desirable traits to wind up with an 

12 edible fruit, with a high-quality fruit that has, 

13 for example, your disease-resistance.

14 So, we thought, how can we get around 

15 this problem of these long generation cycles and 

16 the years and years it takes to produce a new 

17 variety? Well, one solution, we figured, was 

18 maybe hire younger fruit breeders. That came up 

19 with some problems, and I don't especially like 

20 changing diapers. So, we thought, well, maybe 

21 that wouldn't work.

22 The other solution that we came up with 
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1 was what we call FasTrack. It is a breeding system 

2 that utilizes genetic engineering for producing 

3 very fast generation cycles. But, in the end, it 

4 doesn't produce a genetically-engineered final 

5 product. So, I would like to go through that 

6 system with you and show you how we did it.

7 The first thing we did was we had to put 

8 the gene into the fruit tree. So, we are using plum 

9 because plum is really a good system for us. It 

10 is rather easy to genetically engineer.

11 This is the little pieces of plum tissue 

12 that we get the gene into. What we found was that, 

13 when we took a gene from a poplar tree, now that 

14 gene is a gene that normally is part of the 

15 flowering cycle. So, when plants flower, some 

16 genes are turned on; some genes are turned off.

17 And one of these genes was shown in the 

18 literature to, when you turned it on, it would cause 

19 poplar trees to flower early. So, we said, "Let's 

20 see what it would do in plum." Plum has the same 

21 gene, but it was easier for us at that point in the 

22 research to go get the poplar gene because we knew 
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1 how well it worked.

2 It actually didn't work real well in 

3 poplar, but when we put it in plum, it worked very 

4 well. What do I mean when I say, "It worked very 

5 well."? Well, within 10 months after putting the 

6 gene in, we had little plum trees in the greenhouse 

7 flowering and producing fruit. It produced a 

8 fruit within a year.

9 When we took the seed from these little 

10 plum trees in the greenhouse and planted them, we 

11 produced flowering and fruiting plum trees in the 

12 greenhouse that gave us a generation cycle, a 

13 one-year generation cycle.

14 So now, we got pretty excited about that 

15 because we knew now, instead of waiting 

16 three -- actually, plum takes about four years, 

17 instead of three. Peaches take three years. 

18 Plums take about four to six years to produce fruit 

19 from seed. So, we reduced the generation cycle 

20 from four years on average to one year. This had 

21 tremendous potential benefits for our breeding 

22 program.
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1 Here is how it worked. We put the gene 

2 in. We have this tree now. This is a plum tree. 

3 We put the gene in there. You see this little "T"? 

4 That means it has the flowering T gene in it. And 

5 the gene is called the FT gene. Okay?

6 So now, we had this early flowering plum 

7 tree. What we did, then, was we crossed it with 

8 a tree that was, for example, disease-resistant. 

9 And it could be any other trait. It could be high 

10 vitamin C. It could be any trait, but we will say 

11 disease-resistance.

12 We made that cross. Now we could use 

13 molecular markers. And I think molecular markers 

14 are on the accepted list from the NOSB 

15 deliberations.

16 So, when we did that, we wound up with 

17 these early-flowering. Twenty-five percent of 

18 these trees would have the disease-resistance and 

19 the early flowering.

20 We took those to the next generation. 

21 And now, we start crossing back to high-quality 

22 fruit. The system now here is basically the same 
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1 exact system we would use with conventional

2 breeding. The difference is it goes much faster. 

3 So, instead of waiting for each generation four to 

4 six years, we wait one year, and we do our crosses 

5 the same way we would do it through conventional 

6 methods. The only thing is it is very fast.

7 In the end, when we find trees that have 

8 the high-quality fruit, they have the 

9 disease-resistance, that is our last generation. 

10 Now in that last generation we don't take the trees 

11 that have the early flowering gene. We don't 

12 select those. And we don't select the trees that 

13 are not disease-resistant. What we do is we select 

14 the disease-resistant trees that have the fruit 

15 quality that we want. Okay?

16 So now, these are eliminated. These 

17 trees are not considered by the regulatory agencies 

18 to be genetically-engineered. There are 

19 considered to be no different from 

20 conventionally-bred fruit. Now, though, since 

21 that doesn't have the early-flowering gene in it, 

22 we have to wait that four years to see exactly what 
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1 the fruit are going to look like.

2 This cycle here, what we call 

3 back-crossing -- that is, crossing back to 

4 something that we want in terms of high quality or 

5 some other trait that we really want to get into 

6 that plant -- that back-cross breeding takes a 

7 breeder's lifetime in many cases.

8 So, I have been working 36 years, and 

9 now I am really, really seeing the results of all 

10 my years of back-crossing conventionally. I think 

11 we need to do something that is faster than that, 

12 and I will show you in a few minutes why I think 

13 that is true.

14 This process that I showed you here, 

15 this back-cross breeding process here, 

16 conventionally would have taken 20 years. With 

17 the FasTrack breeding it takes eight years. So, 

18 you can see the benefits for a tree fruit breeder.

19 Okay. All right. This is what it 

20 looks like in the greenhouse. These are the little 

21 plum trees that are producing fruit. They are 

22 flowering in the greenhouse. We pollinate them in 
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1 the greenhouse. They produce fruit in the 

2 greenhouse. They even are flowering and fruiting 

3 at the same time. So, here we have fruits that are 

4 ripening and they are also flowering. So, we can 

5 be breeding all year-round in a greenhouse, and 

6 that really speeds up the process.

7 The fruit are normal. We have done 

8 analysis of the compositional analysis. They have 

9 the same composition. They are within the range 

10 of all the plums that we conventionally breed. So, 

11 we have looked at that.

12 Again, now what we are doing is this is 

13 the system that we were using, four-to-six-year 

14 generation cycle, one pollination/fruiting per 

15 year. So, you've got one shot a year to do your 

16 pollinations. If you get a cold snap, you have 

17 lost everything.

18 Disease and insect and weed pressures, 

19 of course, we have this in the field. We lose fruit 

20 because of fruit rots and insects, especially in 

21 the past few years stink bugs.

22 FasTrack, one-year generation. We can 
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1 make the crosses that produce fruit year-around. 

2 We avoid winter and spring injury in the field, and 

3 we reduce insect and disease pressures. So, that 

4 is what we are looking, that is the system that we 

5 are working with.

6 This is the reason, one of the reasons 

7 we are so interested in this system. These are all 

8 exotic insects and diseases. I could show you 

9 three of these slides with everything that has come 

10 in in the past five to ten years.

11 Citrus greening, plum pox virus. Of 

12 course, we know about chestnut blight. We know 

13 about Dutch elm disease. Emerald ash borer, I have 

14 some beautiful big ash trees in my yard. They are 

15 succumbing to emerald ash borer.

16 If we have to wait 30 years -- and for 

17 some of these trees, you are talking more like 70 

18 years, 50 to 70 years to breed insects and disease 

19 in them, where we have lost, we will have lost most 

20 of these species, like we lost chestnuts, like we 

21 lost elm trees.

22 So, we are real interested in this 
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1 because things are not the way they used to be. We 

2 have all these new diseases and insects coming in. 

3 As I say, if we have to wait all the years that it 

4 takes us, we will lose these species.

5 Do I think, then, genetic engineering 

6 is going to solve all our problems? Do I think 

7 FasTrack is going to solve all our problems? 

8 Certainly not. What it is is another tool for the 

9 plant breeders. We need a toolbox that has all the 

10 tools that we can possibly use, I think, to help 

11 agriculture.

12 Is it safe? We feel that all these need 

13 to go through the regulatory process. I think 

14 these decisions have to be made based not on 

15 necessarily the technology, but based on the gene 

16 that was put in and the safety of that gene.

17 So, we are hoping that this will be a 

18 methodology that will gain acceptance because, 

19 certainly, I think for tree fruit agriculture and 

20 our forest species we need to be thinking about what 

21 is coming down the road in the future, not only with 

22 exotic insects and diseases, but with climate 
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1 change.

2 MEMBER DE LIMA: Thank you.

3 I'm going to turn it over to Dr. Hansen.

4 DR. HANSEN: Yes, thank you for 

5 allowing me to speak here.

6 I have also worked on the policy angle 

7 on this issue of genetic engineering for over 

8 20-some years.

9 I should point out, in addition to my 

10 introduction, Consumers Union is a founding member 

11 of Consumers International. That is a global 

12 network of consumer organizations. We have 220 

13 members in 113 countries. And Consumers 

14 International has basically taken a position on 

15 genetic engineering, that there should be required 

16 safety assessments and labeling. And we have done 

17 this since 1988.

18 But, more importantly, CI has been 

19 going to Codex Alimentarius meetings. What Codex 

20 is is that is the food-standard-setting 

21 organization of the United Nations. It is jointly 

22 run by the World Health Organization, the Food and 
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1 Agriculture Organization. It was set up in 1963.

2 The idea behind it was basically to help 

3 developing countries set up food systems for their 

4 countries. And it was all voluntary. It was, 

5 actually, a sort of backwater within the UN, and 

6 that all changed in 1995 because at the Marrakesh 

7 Agreement, when they set up the World Trade 

8 Organization, it turns out Codex gets listed as one 

9 of the -- they call them "the three sisters". 

10 These are three organizations whose standards and 

11 guidelines that come out of them are considered the 

12 de facto global scientific standard.

13 And so, for Codex, since they were 

14 written in as food safety, any Codex standard, 

15 guideline, or our recommendations are considered 

16 trade-legal. So, that means they are not a 

17 non-tariff trade barrier.

18 The reason that this is important is 

19 because Codex spent, actually, eight years in the 

20 early 2000s with this Ad Hoc Intergovernmental Task 

21 Force on Foods Derived from Biotechnology. There 

22 were two four-year sets of these meetings. They 
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1 were hosted by Japan.

2 The four documents that came out of this 

3 eight-year process were the principles for the risk 

4 analysis of foods derived from modern 

5 biotechnology. And then, there were three sets of 

6 guidelines, one for how to conduct food safety 

7 assessments for foods derived from modern biotech; 

8 how to conduct food safety assessments from foods 

9 derived from recombinant DNA microorganisms, and 

10 the third was from engineered animals.

11 The reason that these documents are 

12 important, since they are referenced by WTO, I 

13 should also point out that Codex, under the Codex 

14 Committee on Food Labeling, there's a global 

15 document that regulates organic agriculture as 

16 well.

17 So, this is just from the principles for 

18 the risk analysis of foods derived from modern 

19 biotechnology, and this is the definition that was 

20 finally agreed upon and that is written into, well, 

21 that is referenced in WTO. This is this modern 

22 biotechnology means "the application of (1) in 
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1 vitro nucleic acid techniques, including 

2 recombinant DNA and direct injection of nucleic 

3 acids into cells or organelles or fusion of cells 

4 beyond the taxonomic family that overcome natural 

5 physiological, reproductive, or recombinant 

6 barriers, and that are not techniques used in 

7 traditional breeding and selection."

8 So, this is now the global definition. 

9 What we would like to see is there should be, 

10 basically, coordination with this. What that 

11 means I think for here is, rather than use the USDA 

12 definition, we would like to see that definition 

13 of modern biotechnology become the definition for 

14 genetic engineering.

15 It is basically broad enough that it 

16 does include virtually all the new 

17 genetic-engineering techniques. I have listed 

18 some of them here: cisgenic, intragenic, reverse 

19 breeding, oligonucleotide-directed mutagenesis, 

20 TALEN, meganucleases, ZFN, CRISPR/Cas, RNAi.

21 What is called synthetic biology is 

22 just use of various of these techniques to create 
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1 either new pathways or, ideally, with synthetic 

2 biology -- they haven't done it yet -- but to create 

3 completely synthetic organisms. You can come up 

4 with new nucleotide bases. You can, supposedly, 

5 create chromosomes.

6 They haven't done any of this, but most 

7 of these technologies would fall under the 

8 definition of modern biotech. So, therefore, I 

9 think they should be considered GE and would be part 

10 of the excluded methods.

11 Now what is not included under this 

12 Codex definition is this TILLING, this Targeted 

13 Induced Local Lesions in Genomes. I thought what 

14 I would do now very quickly is just show you some 

15 of these new technologies, these gene-editing 

16 techniques, because they are proliferating.

17 What they allow you to do is one of the 

18 first forms of genetic engineering back in the 

19 seventies -- it was used in the eighties -- is these 

20 endonucleases. Think of them as molecular 

21 scissors where you can cut DNA.

22 And we have just gotten to the point 
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1 that those scissors can be incredibly precise and 

2 they can be designed to cut in a specific place. 

3 And then, you can either have what is called 

4 homologous recombination or this non-homologous 

5 end joining.

6 During each of these methods, that is 

7 when you -- for example, if you are going to change 

8 a single gene, you do this non-homologous end 

9 joining pathway. And then, if you want to insert 

10 larger pieces, you do the homology redirected.

11 So, let me give you some examples. 

12 This was one of the simplest first ones used, this 

13 ODM, this oligonucleotide-directed mutagenesis. 

14 And all they do is, once the DNA starts to unwind, 

15 you put a short nucleotide, an oligonucleotide. 

16 Here's one on the bottom and it is one nucleotide 

17 basis different. It is A here rather than C.

18 So, what happens is, if you add that to 

19 a cell culture system, you can actually mutate the 

20 DNA. So that what happens is this 

21 oligonucleotide, which is exactly identical with 

22 this coding strand of DNA, there is one nucleotide 
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1 difference. So that it basically binds to it and, 

2 then, the cell's own DNA repair mechanism allows 

3 that change to be made.

4 For example, this is what Cibus is using 

5 with this Responsible Trade Development System. 

6 It should be pointed out that, even though these 

7 things appear to be very exact, these small 

8 oligonucleotides, where they find that sequence, 

9 they can glom on there and make a change. And they 

10 are not always exact. There can often be 

11 off-target sequences.

12 So, this is just a paper that was 

13 published earlier this year, well, last year. All 

14 it does is show you the various scissors. The 

15 simplest one is this meganuclease. All a nuclease 

16 is is something that cuts a nucleic acid.

17 The one on the top is just a 

18 meganuclease. That is very hard to control. 

19 Then, you get down to these zinc fingers. Those 

20 are where the sequences that are the same are 15 

21 to 20 base pairs or 20 to 25. Then, what you get 

22 into is -- oops, let me go back; wait a 
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1 minute -- TALEN. That is the second one which the 

2 sort of nucleotide basis that you are making the 

3 same or larger and larger. And then, this third 

4 one or this fourth one down here, this is what 

5 CRISPR is. This is where what you are using is 

6 RNAi. You are using RNA actually to help precisely 

7 target sequences that you want to cut.

8 As an example, here is where they took 

9 in flax, and using the CRISPR system, which is a 

10 bit more exact than the others, they were able in

11 this EPSPS gene to make two nucleotide-based 

12 changes, here and here. Then, what that does is 

13 that mutates that loci and it becomes tolerant now 

14 to herbicides. So, that is an example.

15 And this is just a summary that looks 

16 at the zinc finger nucleases TALEN and CRISPR. It 

17 just shows you that, as you get to longer and longer 

18 sort of flanking regions, like with CRISPR and 

19 that, you can get more and more exact. Although 

20 it should be pointed out, even with CRISPR, you 

21 can't exactly control where things are done. So, 

22 it should be pointed out that, when they have tried 
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1 to use CRISPR to edit human embryos, all the 

2 scientists have gotten together and have basically 

3 said, "We don't understand this technology well 

4 enough," even though it is more precise than 

5 previous methods, for example, of using a 

6 biolistics gun to shoot DNA into a Petri dish, this 

7 is far more exact, but they still can't precisely 

8 control it. That is why they argued that there 

9 should be no use on human embryos, because we still 

10 don't completely understand the off-target 

11 effects.

12 And I would point out that the same 

13 thing happens in plants. So, even though it 

14 appears to be more precise, we really have to look 

15 very carefully to see what other things are being 

16 disrupted.

17 Then, I guess, to end what I would like 

18 to say, is if we look at some of these other 

19 techniques, we will see that, even though the 

20 definition at Codex does actually exclude or does 

21 include -- well, I should say excludes cell fusion 

22 within the taxonomic family, that is something that 
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1 does, I think, have to be debated within the 

2 community.

3 The same thing is true with induced 

4 mutagenesis, whether you are using chemicals or 

5 radiation. That is something that has been done 

6 for decades and decades. And some people might 

7 want to consider that outside the definition. 

8 Again, I think that is something that is going to 

9 have to be decided more broadly in the community.

10 I will say I do like the criteria you 

11 have in here, but this document needs to actually 

12 reference all organisms, not just plants, not just 

13 microrganisms. But you heard about the engineered 

14 insects that might be being tested in upstate New 

15 York this year or next year. And so, we need to 

16 include all these organisms in the sort of 

17 definition of genetic engineering, and they should 

18 be excluded from organic.

19 And then, other ones that are here, like 

20 cisgenesis and intragenesis, they are on the TBD, 

21 but I'm familiar with those. Those use a 

22 genetic-engineering technique. So, I would argue 
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1 that both of those should be moved to the yes 

2 category, that they would be excluded.

3 I agree with the fact that 

4 marker-assisted as a selection is not an excluded 

5 technology, but a lot of these other ones, the cell 

6 fusion within plant family, embryo rescue, and even 

7 some of the, I think, transposons on some sense it 

8 sounds like it is silly that that is there, but we 

9 now know in plants like maize and that, that when 

10 you cross plants, you can actually induce mutations 

11 being caused by these transposons.

12 So, if it part of the conventional 

13 breeding process, I think it is sort of fine. Just 

14 like if you think about a transduction, that is if 

15 you are using phages, you know, as a form of pest 

16 control. Where I think it would switch over into 

17 an excluded category is if any of the parts of it 

18 have been engineered or have been manipulated using 

19 modern biotechnology.

20 Other than that, I did think this 

21 document, particularly the criteria, the 

22 principles, those four principles, those are 
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1 actually very, very good ones. But, for your 

2 criteria and that, you need to expand to make sure 

3 that it includes all organisms.

4 Finally, on synthetic biology, what I 

5 would like to say there is, it is okay to have the 

6 language. There is some vague language on 

7 synthetic biology, a definition that is the 

8 definition that has come out of the Cartagena 

9 Protocol. If you just look at the wording itself, 

10 that is a further development, a new dimension, of 

11 modern biotechnology that combines science 

12 technology and engineering to facilitate and 

13 accelerate the understanding, design, redesign, 

14 manufacturing, and/or modification of genetic 

15 materials, living organisms, and biological 

16 systems.

17 It sort of seems so broad that it is 

18 somewhat meaningless, but I think it is fine if you 

19 want to keep this language in here. The reason 

20 that this is being discussed at the Cartagena 

21 Protocol is because there is this difference. In 

22 the Protocol the definition of modern 
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1 biotechnology is the same in Codex and under the 

2 Convention on Biodiversity. However, they did 

3 define living modified organism rather than just 

4 be an organism that has been modified through the 

5 use of modern biotechnology. In the Cartagena 

6 Protocol they added a few words, and that is you 

7 have to have a novel genetic combination.

8 And that is a loophole that has been 

9 created. So, many of the countries and NGOs and 

10 others are there trying to ensure that synthetic 

11 biology techniques don't slip in, because what 

12 constitutes a novel genetic combination? 

13 Whereas, in Codex, any organism or cell that is 

14 created using or manipulated using modern 

15 biotechnology would fit into that definition. I 

16 think that makes it excluded. So, the reason you 

17 have all this arguing, from my viewpoint, under the 

18 Protocol with synthetic biology is because of this 

19 loophole, and they are trying to patch that up.

20 But I would point out that the U.S. 

21 never became a party to the Convention on 

22 Biodiversity. We are a member of Codex, and the 
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1 Codex definitions are written into the WTO or are 

2 referenced. So, I would say, to be consistent, we 

3 should be using those.

4 And I would still argue you should still 

5 use the term "non-GMO" and "genetic engineering" 

6 or "genetically-modified organisms". And you can 

7 just define them in reference to modern 

8 biotechnology. And that would be fine.

9 Thank you.

10 MEMBER DE LIMA: Thank you.

11 Dr. Tracy?

12 DR. TRACY: Yes, thank you for inviting 

13 me. I know what a big job you guys have, and I want 

14 to thank you for the work you do as well.

15 I also want to thank Zea for an 

16 excellent document. I read the document pretty 

17 carefully. I read some of the comments. I have 

18 had numerous conversations.

19 The first thing I want to say is that, 

20 usually, in my normal day-to-day work, we are 

21 talking mostly science. Seldom do we talk about 

22 ethics. Seldom do we talk about values. Seldom 
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1 do we talk about social impacts. Probably don't 

2 do it enough.

3 But I want to make that point here 

4 because, as you go through this document, that is 

5 an incredibly important part of what you folks are 

6 doing. This is not just about the science. This 

7 is about values and principles, about how organic 

8 farmers and processors want to conduct their lives.

9 That said, I would also say that it is 

10 critical really to talk about what organic is and 

11 not what it isn't. Talk about things like building 

12 soil and talking about the ethical and sociological 

13 values.

14 In this document you have a number of 

15 different sets of principles. Well, and I have 

16 actually picked up a couple of other ones as well 

17 that I want to mention. The NOSB has its own set 

18 of principles of organic production and handling 

19 in the Policy and Procedures Manual, and I won't 

20 read the whole paragraph. But "Organic 

21 agriculture is an ecological production management 

22 system that promotes and enhances biodiversity, 
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1 biological cycles in soil, biological diversity."

2 Also, I think the IFOAM principles are 

3 in the document, and David talked about them. But 

4 the principle of health, the principle of ecology, 

5 the principle of fairness. That often doesn't 

6 come up in my day-to-day life. We talked about 

7 that one very much. Principle of care.

8 Michael Sly brought forward ideas from 

9 RAFI, precaution, compatibility, transparency, 

10 responsibility, access and sharing, farmer choice, 

11 and consumer trust. And the OSGATA group has 

12 principles specifically for organic plant 

13 breeding, "respects plant integrity, supports 

14 genetic diversity, remains farm-centered, and 

15 honors the public domain". So, these are big 

16 things. When we start talking about these 

17 different processes, we have to think about those 

18 as well.

19 The other thing I want to mention that 

20 I think is key to this conversation is that in the 

21 NOSB document that Zea's Subcommittee put 

22 together, it says, "Since the whole underpinning 
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1 of the U.S. organic regulations is a process-based 

2 system, it makes sense that this concept carry over 

3 to defining excluded methods. This is, indeed, 

4 the basis of the current definition."

5 So, basically, if we are looking at 

6 these techniques or technologies with the idea of 

7 a process rather than a product standpoint -- and, 

8 also, another point I want to make, which Michael 

9 essentially alluded to, was that in the NOSB 

10 principles it also says, "genetically-engineered, 

11 modified organisms and products produced by or 

12 through the use of genetic engineering are 

13 prohibited."

14 When you take all of this together, I 

15 think some of these decisions or some of these 

16 included or excluded technologies become very 

17 clear, and it becomes pretty easy to sort them into 

18 different categories.

19 Now the big question for you 

20 folks -- and some of these things are already NOSB 

21 principles, so I'm not thinking you want to change 

22 those -- but it is really up in those principles 
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1 and definitions and criteria that things become 

2 really critical. Because once you set those, then 

3 the other things are relatively easy, at least in 

4 sorting into different categories.

5 We were all asked to explain some of the 

6 terms of the terminology chart that you feel 

7 comfortable with or knowledgeable about in the 

8 context of the definition of "excluded methods". 

9 Targeted genetic modification, Michael talked 

10 about that in depth.

11 We are hearing a lot about gene editing 

12 and CRISPR/Cas9. That is the real hot one right now. 

13 In fact, Michael gave a pretty good description, 

14 and it is a pretty accurate form of mutagenesis. 

15 And it is a much safer form in terms of for the 

16 person who is doing the mutagenesis than the 

17 old-fashioned mutagenesis of x-rays or chemical 

18 mutagenesis.

19 So, much like Michael said, it is an 

20 accurate form of mutagenesis, but it does require 

21 GM technology, even though the product itself won't 

22 have the GM in it. If that is a criteria or a 
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1 standard that NOSB takes into account, it is fairly 

2 easy for me to put that into a category.

3 Unfortunately, celebrated breeding 

4 techniques fall into the same thing. As Dr. Scorza 

5 said very clearly, there was a transgene put in to 

6 accelerate that.

7 Another interesting one that I will 

8 just mention is cisgenesis. Cisgenesis is also 

9 transformation, and therefore, again, according to 

10 these rules, would not be included. Cisgenesis is 

11 an interesting thing as opposed to the more typical 

12 transgenesis. Cisgenesis is where, essentially, 

13 all of the genetic material that is transformed 

14 into an organism comes from the same species or a 

15 very closely-related species.

16 And you might say, well, why would you 

17 want to go to the trouble? Well, if you have 

18 something like a citrus plant, a navel orange or 

19 a clementine tangerine, something like that, as Dr. 

20 Scorza knows, you can't just cross that quickly and 

21 get something new if you have a disease. But, if 

22 you could actually, through cisgenesis, transform 
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1 a gene in, that would be a very quick technique that 

2 would allow disease resistance in a 

3 clonally-propagated crop. But, again, it would 

4 not be possible under the current criteria.

5 Other terms, "TILLING in corn," in corn 

6 TILLING is -- you've got it up there -- Targeted 

7 Induced Local Lesions, thanks to my colleague here. 

8 This is a really common method in corn to find 

9 genes, to find where they are in the genome, and 

10 then, also, sequence them. And TILLING in corn is 

11 completely natural because corn has internal 

12 transposons. If you cross something with active 

13 transposons to another corn line, you get all of 

14 these induced lesions. So, TILLING in the case of 

15 corn is 100 percent natural.

16 Double haploids, there are new methods 

17 being developed at Iowa State that would eliminate 

18 the toxic chemicals in double haploids. And 

19 double haploids, for those of you that don't know, 

20 is a quick way to make inbreds. So, rather than 

21 going through a repeated selfing process of six or 

22 seven generations, a double haploid can be made in 
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1 a period of a year-and-a-half as opposed to five 

2 or six years for a regular inbred.

3 I would also say embryo rescue is a very 

4 old technology. I actually have a clone in my 

5 greenhouse of a cross between corn and Tripsacum, 

6 which is a relatively-distant ancestor of corn. 

7 The clone was made through embryo rescue in the 

8 forties.

9 Basically, an embryo rescue, all you 

10 really have to do -- the reason we have to do embryo 

11 rescue is because often in these wide crosses the 

12 embryo and the endosperm, which is the tissue, 

13 essentially, like the yolk in an egg, the endosperm 

14 and the embryo are incompatible. So, all you have 

15 to do is remove that embryo before, essentially, 

16 it dies because of the incompatible endosperm. 

17 You can, then, just culture -- usually, it is done 

18 on some kind of media, but it could be done even 

19 simpler than that. Again, embryo rescue is an old 

20 technology and I think it is something that I think 

21 could certainly fall within the standards.

22 Induced mutagenesis, I already 
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1 mentioned that. The old random style, the 

2 chemicals are dangerous for the people who are 

3 handling them. X-rays, you all know about that.

4 On the other hand, there are lots of 

5 important cultivars that were developed through 

6 this technology. And eliminating that as a 

7 possibility would cause considerable disruption, 

8 at least in some sectors of ag.

9 The other thing I want to mention is 

10 many of these newer techniques, including 

11 FasTrack, including most of the gene-editing 

12 systems, as far as I know, there will not be tools 

13 to actually detect them. The transgenic part has 

14 gone away by the time the product is out in the 

15 marketplace. So, that does complicate the 

16 discussion.

17 As far as the criteria, I also agree. 

18 The one that I have a little bit more question about 

19 this novel protein one. I think that one we need 

20 to be a little more specific there.

21 The other one I want to also point out 

22 here is the criteria. For those of you who don't 
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1 have the document in front of you, the second one. 

2 It says, "the ability of a variety to reproduce in 

3 a species-specific manner has to be maintained and 

4 technologies that restrict the germination 

5 capacity are refrained from".

6 The one that I immediately think of 

7 there is, what about the seedless watermelon? I 

8 don't know what to do with the seedless watermelon. 

9 That is a problem. We can live without seedless 

10 watermelons. You know, we all enjoy spitting 

11 watermelon seeds, at least when we are kids. So, 

12 maybe that is okay.

13 And then, finally, I want to say that 

14 I strongly support the fourth criteria in Zea's 

15 document. The exchange of genetic resources is 

16 encouraged, and any patenting -- and I would there 

17 really say "utility patenting" -- of living 

18 organisms that might have life gene sequences or 

19 breeding should be refrained from. So, I strongly 

20 support that.

21 With that, I will end and be happy to 

22 answer any questions.
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1 MEMBER DE LIMA: Thank you to all of 

2 you.

3 I want to open it up to questions from 

4 the Board.

5 Zea?

6 MEMBER SONNABEND: Okay. I'm sure 

7 most of the audience's eyes have glazed over and 

8 maybe my fellow Board members. But I find this all 

9 very fascinating.

10 I'm going to address this first 

11 question to any of you who wishes to answer. But 

12 we received among the most critique from our public 

13 commenters about the first and the third criteria. 

14 We totally understand the third criteria, which is 

15 "Novel proteins must be prevented from being 

16 introduced," and that just has lack of clarity. 

17 So, I'm not asking about that.

18 But the first criteria which it says, 

19 "The genome is respected as an invisible entity and 

20 the technical physical invasion into the plant 

21 genome is refrained from." And this was taken from 

22 IFOAM. We got, unexpectedly, a lot of critique 
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1 about the word "invasion".

2 You know, the sentence construct to me 

3 is very European in nature, and I thought we would 

4 get other critique about the way it was worded, but 

5 people tended to single out the "invasion". A 

6 number of alternative words were suggested. But 

7 I am wondering if any of you have a reaction to that, 

8 like "invasion" implies something different from 

9 what we might want it to.

10 DR. TRACY: I actually made a comment 

11 as well, at least in my notes, not to you, about 

12 this.

13 But I would be inclined to get rid of 

14 this technical and physical part and be much more 

15 specific. I think mainly there you are talking 

16 about recombinant DNA technologies, basically.

17 DR. GOULD: Yes, I agree that it needs 

18 some greater clarity, and I think what Bill is 

19 talking about is one of the ways to do that. I 

20 don't think that internally in IFOAM discussions 

21 there has been a lot of discussion about this 

22 because it was created -- I have to say this 
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1 predates my own history -- by people who seemed to 

2 implicitly understand what it was. And back when 

3 it was created, we weren't in this complex of the 

4 discussion. So, it is something we could revisit.

5 DR. HANSEN: Yes, and I also wonder if 

6 it was a language thing. I mean, I also believe 

7 maybe the term "invasion" is a bit strong, but maybe 

8 they meant some kind of insertion.

9 And I would say it is not just the 

10 recombinant DNA techniques. If it is genetic 

11 material from the same organism or if it is 

12 RNA -- so, I do like at the end where they pointed 

13 out that in vitro nucleic acid techniques are 

14 considered to be -- again, "invasion" has a value 

15 judgment. So, you could use some more neutral term 

16 and "insertion".

17 MEMBER DE LIMA: Thank you.

18 DR. HANSEN: Because part of the 

19 problem is we don't really have control over where 

20 these things are inserting. If you think about it 

21 from an ecological or evolutionary perspective, 

22 even when you're mixing big genomes or with 
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1 radiation, these organisms which have co-evolved 

2 over long periods of time have ways to deal with 

3 a number of things.

4 And I think it is part of the hubris 

5 humans to come in and say, "Oh, we have this nice, 

6 precise molecular scissors. We'll know exactly 

7 what we're doing with it."

8 Just as an example, two weeks ago in 

9 Nature there was a publication of they decided one 

10 of the ways that they could try to cure HIV is to 

11 engineer T helper cells because that is how the 

12 virus invades the immune system. So, they 

13 engineered these T helper cells to have CRISPR in 

14 them that would recognize HIV, with the idea being, 

15 now when HIV tries to enter those T helper cells, 

16 it is immediately destroyed with this new 

17 CRISPR/Cas9. In the cell culture system they 

18 used, it took two weeks. Within two weeks the HIV 

19 had hijacked the CRISPR and had evolved a way around 

20 it.

21 So, I think what we have to realize is 

22 these genetic-engineering techniques, what they 
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1 have been most useful for is in our basic 

2 understanding of how truly complicated genetics 

3 really is. And when people come in and think, oh, 

4 we have this new little mechanism that we can do 

5 exactly what we want, I think we find out that, no, 

6 there's actually other things happening as well, 

7 because we don't really understand this incredibly 

8 complicated system.

9 So, I think there needs to be a lot more 

10 respect for the integrity of these things and a lot 

11 less scientific hubris on our part. And organic 

12 has been very good at that, about trying to respect 

13 what are considered more natural systems. And so, 

14 it makes sense that you would want to refrain.

15 DR. GOULD: Zea, I don't know if there 

16 were specific suggestions in those comments. I 

17 haven't had a chance to read them yet. But one of 

18 the things that I do see in this, also, it says, 

19 "for example, through transmission of isolated 

20 DNA, RNA, and proteins". That would address what 

21 Bill was talking about. But one of the ways in 

22 which we could potentially improve this would be 
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1 to get rid of the "for example" and actually make 

2 potentially a more exhaustive, specified list of 

3 the kinds of invasions we are talking about.

4 MEMBER DE LIMA: Dan?

5 MEMBER SEITZ: It seems to me that one 

6 of the challenges in public perception around GE 

7 is that often the benefits are immediate in terms 

8 of something that you can accomplish through 

9 genetic engineering. Whereas, the harm may become 

10 evident down the road.

11 And I think that is what you, Dr. 

12 Hansen, were just referring to, is that there may 

13 well be harm, but it could be not evident until the 

14 technology is well-integrated perhaps into 

15 people's practices, or whatever.

16 And I think where the precautionary 

17 principle comes from is this idea that, one, living 

18 systems aren't like inorganic systems where you can 

19 perhaps engineer more exactly; that there are 

20 always or there are likely to be these unintended 

21 consequences.

22 So, with that, considering Dr. Scorza's 
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1 point, here is a technique that seems to address 

2 some very immediate harms, whether it is certain 

3 invasive pests, or whatever. It speeds up a 

4 process.

5 To a layperson, it may seem like this 

6 is something that would not necessarily have any 

7 disadvantages. But I am wondering from the 

8 perspective of the other panelists, looking at 

9 something like that, how much you reflect on the 

10 precautionary side of that? What may become 

11 evident down the road? Or how would you reflect 

12 on that?

13 DR. HANSEN: Yes, what I was going to 

14 say, very quickly, is one of the concerns that we 

15 have always had with genetic engineering, it is the 

16 unintended consequences, unless you have scanned 

17 that whole genome. What they have done is they, 

18 through the conventional GE techniques, they have 

19 inserted a gene. They didn't scan the rest of the 

20 genome to see what else got disrupted or anything 

21 else. They looked just at agronomic 

22 characteristics of the plums and other things. 
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1 They didn't look in a more expansive way. And that 

2 is the concern that we would have, that you need 

3 to do that.

4 And I should also point out that what 

5 has made a lot of this far more difficult are 

6 utility patents. The fact that you can patent 

7 these things means that you control the research 

8 that gets done. So, that means, unlike with the 

9 old Plant Variety Protection Act where there were 

10 farmer and researcher exemptions, those are gone. 

11 So, there is no way for independent researchers to 

12 go out and ask hard, critical questions because 

13 they have to get approval from the company or the 

14 holder of these utility patents.

15 And now, you can get them on 

16 conventionally-bred plants and even organic ones. 

17 That should never, in my mind, should never be 

18 allowed. Those utility patents should not be 

19 allowed. Any plant or organism, it should be like 

20 the old Plant Variety Protection Act. There 

21 should be farmer/researcher exemptions, because 

22 that is the only way.
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1 I think with some of these things, if 

2 there is a lot of research done and these things 

3 turn out to fine, then, yes, they can be used more. 

4 But a lot of us have learned through hard

5 experience, whether it is pesticides or all these 

6 other things that were brought on the market, and 

7 we were told that they were perfectly safe, only 

8 to find out years later that they weren't.

9 DR. SCORZA: I would like to address 

10 the question. The intention is not to just look 

11 at agronomic traits. The intention is any variety 

12 that is released through FasTrack will be entirely 

13 sequenced; the genome will be entirely sequenced. 

14 It is relatively cheap these days to do that, and 

15 that is what would be done.

16 So, I think we have a great concern 

17 about doing this right. We are not interested in 

18 profit out of all this work. We are not interested 

19 in anything but really doing what we are doing with 

20 conventional breeding, developing new varieties 

21 that have interesting traits, traits that are 

22 really needed by the growers and consumers. And 
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1 we want to do it safe, very safely.

2 So, we already went through the talk 

3 with the regulatory people. What would be 

4 required to release a variety through FasTrack? 

5 And I will tell you that the FasTrack system is 

6 patented. Why is it patented? It is patented so 

7 that the U.S. Government, the USDA will have 

8 control over anybody who works with it, that we will 

9 make sure that our partners in that will have the 

10 rigorous study of the genome of anything they 

11 release, instead of just releasing the technology 

12 and, then, not really knowing how carefully users 

13 of the technology will check the plants that are 

14 eventually released.

15 So, I think we really are trying to 

16 address those concerns with this technology. 

17 Whether society thinks that we have done enough, 

18 you know, we can't predict. But we really are 

19 trying to do the best that we can to use this 

20 technology safely.

21 And again, we are not using FasTrack in 

22 all our breeding. We are using conventional 
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1 breeding when it makes more sense. We are using 

2 FasTrack when it makes more sense.

3 So, again, it is a tool, and it is a tool 

4 that we want to use as safely and as carefully as 

5 possible.

6 DR. TRACY: I would also like to add the 

7 same kind of thing. When a variety is developed 

8 conventionally, totally classically 

9 conventionally, the same kind of problem can occur.

10 There is a famous example of a potato 

11 that had high, I believe -- well, it had a toxin 

12 in it, and it was only after people started eating 

13 a lot of it that it was found.

14 So, it can happen conventionally. I 

15 think the main thing that I think Ralph and I back 

16 when we started, we were taught as plant breeders 

17 that you tested the heck out of everything before 

18 you ever released it. Now I would say that 

19 often -- everything in life now goes so fast, that 

20 I'm not sure if something -- and I'm not talking 

21 about this case, but sometimes things don't get 

22 maybe tested as well as they should be. But we just 
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1 have to do repeated testing, even of the 

2 conventional variety, to make sure it is safe.

3 DR. GOULD: Yes, I would just say that, 

4 you know, we are identifying a problem here, but 

5 there are other solutions as well. As I said 

6 before, one of the things that we need to do is to 

7 devote far more resources than we do to alternative 

8 methods of breeding.

9 I think that there is a myth, I have to 

10 say, that is promulgated -- I don't want to say 

11 "against us," but maybe as an organic sector, that 

12 somehow we have to abide by this idea that 

13 everything must go faster. With all due respect, 

14 I really appreciate the concerns that Ralph raises 

15 about these diseases that are coming on and we need 

16 to have these problems. So, we can't race 20 years 

17 into the future now, but we can start to initiate 

18 more kinds of alternative breeding techniques and 

19 a greater frequency of those techniques at any one 

20 time, to try to come to some better solutions.

21 But the idea that somehow organic needs 

22 to have all of these new techniques I think is also 
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1 a little bit of myth. If we actually had more 

2 organic and sustainable production, we would be 

3 solving a lot of the world's problems anyway. So, 

4 the problem is kind of couched in the wrong 

5 paradigm.

6 I will be just a little hyperbolic here. 

7 The idea that we need to rush so much is almost like 

8 saying that you should be applying super-phosphate 

9 instead of rock phosphate. And we have tried 

10 techniques that work and we need to make those 

11 better using the paradigm and the principles that 

12 we know that have worked.

13 MEMBER DE LIMA: Francis?

14 MEMBER THICKE: I was intrigued by 

15 something Dr. Tracy said about how the utility 

16 patent should be refrained from. Since your 

17 Department, you're at a land grant university, how 

18 widely is that shared in the land grant system? 

19 Are you an outlier?

20 DR. TRACY: Frequently.

21 (Laughter.)

22 This is something that I have been 
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1 really, as the people in our tech transfer agency 

2 would agree, fighting for years. And I would 

3 distinguish patenting a process like FasTrack from 

4 actually patenting a cultivar, a utility patenting 

5 cultivar.

6 We have other mechanisms, including 

7 PVP, including plant patents, to protect crop 

8 cultivars. Those mechanism actually keep the 

9 genes in the public sector, so that new varieties 

10 can be developed.

11 The problem with the utility patent, 

12 among the other things that Michael mentioned, 

13 including preventing actual research on the 

14 product, the other problem with the utility patent 

15 is that the genes are not available for breeding 

16 in the public sector or for any sector. So, the 

17 genes are tied up.

18 Whereas, the traditional methods, the 

19 PVP, which I'm 100 percent fine with, plant patent, 

20 those mechanisms actually allow the genes to be 

21 immediately available or should, according to the 

22 law, should be immediately available.
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1 And we actually are having -- "we," a 

2 group of us -- are putting on an IPR for public plant 

3 breeding workshop or summit in Raleigh, North 

4 Carolina, August 13th. The purpose is really to 

5 try to get an idea of best practices in the public 

6 sector, so that when a young person has to argue 

7 with their tech transfer agency, they might have 

8 some information that they can go forward with.

9 MEMBER DE LIMA: Emily?

10 MEMBER OAKLEY: We received a couple of 

11 comments from livestock folks about the embryo 

12 transfer in animals. And I was wondering if some 

13 of you could comment on that, because they want us 

14 to remove it as an excluded method.

15 DR. GOULD: I don't know how much I can 

16 say about it, but I think consensus is pretty clear 

17 that we should not do that.

18 MEMBER DE LIMA: Tom? Then, Zea.

19 MEMBER SONNABEND: One thing --

20 VICE CHAIR CHAPMAN: Wait.

21 MEMBER SONNABEND: What?

22 MEMBER DE LIMA: Tom? Then, Zea.
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1 VICE CHAIR CHAPMAN: It's all right, 

2 Zea.

3 Dr. Tracy, you touched on this a bit, 

4 but do we need to define traditional plant 

5 breeding? Is it clear to you on the panel that the 

6 practices used in traditional plant breeding are 

7 allowed under these principles, criteria, and 

8 definitions that we have here as they are now?

9 DR. TRACY: I think we do need to get 

10 a better definition, and I know there's been many 

11 people, both in the organic community and the 

12 conventional plant breeding community, that have 

13 kind of resisted that. But I do think that a 

14 document like this says that we do need to become 

15 more specific.

16 I think what is interesting about the 

17 document here or the technologies here -- and this 

18 would be exactly the same for FasTrack as 

19 well -- well, FasTrack is a little different. That 

20 speeds things up. But a lot of these technologies 

21 simply introduce variation. And then, what you do 

22 with the variation is kind of the classical 
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1 plant-breeding part. And even the big companies 

2 like Monsanto and DuPont, they do a lot of classical 

3 plant breeding, but their variation may come from 

4 transgenes or other places.

5 So, it is really where the 

6 variation -- well, in part, this document is about 

7 where the variation comes from. And then, 

8 classical or plant breeding kicks in after that. 

9 But I do think we probably need to tackle that.

10 DR. SCORZA: May I say something about 

11 that? I think the word "traditional" or 

12 "classical," I really don't know how far you go back 

13 with that. Because I know in fruit trees and 

14 grapevines, they have been for years doing, for 

15 example, embryo rescue, for years most of the 

16 early-ripening peaches were all developed through 

17 embryo rescue. So, is that traditional? Is that 

18 conventional?

19 It is almost like you have to go to some 

20 crops and say, how far do you want to go back to 

21 say what's traditional in their crop, 100 years, 

22 50 years, 500 years? So, I think that is a question 
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1 I have in my mind. That word "traditional," how 

2 far back does it go? So, that is something I think 

3 could be considered. I don't know if you could do 

4 it crop by crop, but, certainly, there is some way 

5 that -- some breeder is going to come to you and 

6 say, "But this is traditional. We've been doing 

7 this for 100 years." In another crop, no, they 

8 haven't been doing that. So, it is something to 

9 consider.

10 DR. GOULD: When something withstands 

11 the test of time or the precautionary principle is, 

12 I guess, a debatable question, one we probably need 

13 to still come to grips with.

14 But our original GMO position 

15 paper -- and it was carried over, actually, into 

16 the current redraft, which is about to be kind of 

17 approved, I guess, or voted on, -- insists on 

18 precise definitions for what is genetic 

19 engineering, what is a GMO. We need to, I think, 

20 update those traditional as not, as we have just 

21 seen.

22 Actually, our original position paper 
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1 said that -- it called modern biotechnology a 

2 non-precise term because it wasn't defined. So, 

3 if it is defined precisely, I don't know that it 

4 necessarily matters as long as it really is clear. 

5 So, we may not be, at least in the near future, able 

6 to achieve the exact same definitions or which 

7 terms are defined here in the United States versus 

8 Europe. Maybe at the Codex level we will be able 

9 to do that. But that is a long process and, as I 

10 said, this whole technology is moving way faster 

11 than that. So, as long as we are all clear in each 

12 of those contexts with a precise definition, I 

13 think we are okay. But that is something which 

14 needs to be fixed here.

15 DR. TRACY: I just want to follow up. 

16 One other thing on that is that plant breeding 

17 actually includes lots of things, and there's kind

18 of a whole area of plant-breeding research, 

19 genomics and research on germplasm.

20 So, to really be clear about what we are 

21 largely talking about here is I have really kind 

22 of gone to the topic of cultivar development. 
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1 We're actually trying to develop a new variety as 

2 opposed to doing some genetic manipulation. To 

3 learn more about genome as an academic researcher, 

4 I do that, but that is different from actually 

5 developing new varieties.

6 MEMBER SONNABEND: Actually, Tom asked 

7 my exact question.

8 VICE CHAIR CHAPMAN: I have a follow-up 

9 question or maybe just a clarification. But I 

10 think, to build on what you said, so you guys would 

11 consider yourselves experts in plant breeding. 

12 But, with these definitions being requests 

13 encompassing all organisms, I took it that you guys 

14 weren't as comfortable to speak across all of those 

15 other organisms, is that correct?

16 DR. HANSEN: Well, I think, actually, 

17 those terms can be used because we did this at the 

18 Codex process from microorganisms to animals, 

19 including fish and invertebrates all the way, and 

20 then, plants as well.

21 So, I do think that a lot of the 

22 terminology you can use and extend it, although 
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1 when you get into, for example, insects, it raises 

2 serious questions, like these diamondback moths. 

3 Even though they are engineered and it would be 

4 clear that they are not part of organic, if they 

5 were released on any kind of large scale in upstate 

6 New York, the way they worked is they die in the 

7 early instars.

8 So, that means if they are out there, 

9 there can be completely organically-raised 

10 broccoli and cold crops since you have these early 

11 instar engineered larvae in them that are dead now. 

12 Are people going to want to eat that? What is that 

13 going to do? Those are real questions that have 

14 to be grappled with, once you get out of plants and 

15 you start to open this whole field up, particularly 

16 for insects, because they can move all over the 

17 place.

18 DR. TRACY: The other thing I would 

19 say -- and I'm not an expert on this, although I 

20 took a course in it a long time ago -- but bacteria 

21 especially are completely different kinds of 

22 organisms, and they do different things. Their 
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1 genetics are completely different. So, I think 

2 you would really need to get a microbial geneticist 

3 involved in this because I don't think things 

4 directly correspond.

5 But, as far as you carry it, it is 

6 basically everything but bacteria and viruses. I 

7 think most of this is probably similar.

8 DR. HANSEN: Actually, fungi, too, 

9 because fungi get very strange because they don't 

10 have cell walls. Yes, it is very different.

11 DR. GOULD: I think we are going to have 

12 to try to make the criteria as broadly applicable 

13 as possible because there are going to be new 

14 combinations and new techniques coming. So, I 

15 don't know that we will get to the end-all, but I 

16 think that the criteria have to be considered with 

17 all the species together. And what we have here 

18 is a good start.

19 I don't know that there is going to be 

20 necessarily too many other kinds of specific 

21 details that we are going to miss that are going 

22 to eliminate one phylum or another or kingdom or 
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1 another.

2 MEMBER DE LIMA: Harriet?

3 MEMBER BEHAR: One of my concerns, 

4 also, is just we are talking about biology. 

5 Organisms tend to mutate on their own. So, if we 

6 have genetically-engineered something, will it not 

7 mutate into something that we didn't plan? And 

8 when we talk about microorganisms and bacteria and 

9 insects -- you know, I'm not a geneticist; I don't 

10 have a triple PhD, but basic high school biology 

11 tells me that these are organisms that tend to 

12 mutate rapidly because there are many generations. 

13 So, I think that is another issue that we have here. 

14 Or am I wrong?

15 DR. TRACY: Biology is all about 

16 reproduction and finding ways to reproduce. Some 

17 of the human hubris that we talk about is, "Oh, we 

18 can prevent that from doing that." As I said at 

19 lunchtime today, every time there is a meiosis, 

20 which is the formation of a sex gamete, I consider 

21 every time there is a meiosis, that is a new genetic 

22 experiment.
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1 Somebody gave me, actually, a statistic 

2 recently that every base pair in the maize genome 

3 during the summertime in North America is mutated, 

4 every base pair is mutated 400 times. So, they are 

5 trying to figure out a way to get around whatever 

6 we put in front of them, and I think it is really 

7 amazing.

8 So, yes, I think the hubris where we 

9 say, "Oh, we can contain" this or that is often 

10 proved to be wrong.

11 DR. GOULD: Harriet, I didn't 

12 completely -- I mean, I agree with you, but I didn't 

13 understand. Is your question heading somewhere or 

14 looking for something in particular out of --

15 MEMBER BEHAR: Well, I wasn't sure, and 

16 we already have all these genetically-engineered 

17 organisms, crops and some bacteria, yeasts. But 

18 I guess, because of patenting, we are not tracking 

19 if there are mutations out there.

20 We know, for instance, in Roundup-ready 

21 corn and soybeans, we know that the weeds have 

22 mutated to become resistant to the herbicide, but 
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1 we don't know if there has been any mutation to 

2 those plants. I mean, they are not stable, either. 

3 I mean, we don't know how we have manipulated to 

4 the genes. So, further mutations, where that is 

5 going to take us?

6 DR. GOULD: I agree. I mean, there is 

7 something I read years ago which kind of forwarded 

8 the premises that, when you start disturbing the 

9 genome like that and destabilizing it, 

10 essentially, you give it more of an impetus to 

11 destabilize. That makes intuitive sense to me. I 

12 don't know if it is absolutely true.

13 It is just kind of highlights, I 

14 suppose, the severity and the complexity of the 

15 problem that we are facing. It seems to me that 

16 one of the things that we are trying to do is put 

17 some kind of filter on that and some kind of 

18 limitations on what we would allow ourselves as 

19 humans to do, as opposed to what we will let Nature 

20 do. You know, what Nature is going to do now is 

21 really beyond our control.

22 DR. TRACY: Yes, the other thing with 
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1 your specific example is that, essentially, on 

2 those 90 million acres of corn and 90 millions acres 

3 of soybeans in the Midwest they actually don't 

4 leave any reproductive units. They all, 

5 basically, are swept off the landscape and fed to 

6 somebody, for the most part.

7 But an interesting case, and what you 

8 are raising, is transgenic alfalfa. I mean, that 

9 is a perennial. It is out on the landscape. It 

10 is reproducing. It can be clonally-reproduced. 

11 It can be sexually-reproduced. And that will be 

12 an interesting evolutionary experiment.

13 DR. SCORZA: Yes, I would like to take 

14 off a little bit on what Bill said here. We are 

15 in a sea of constant genetic mixing and genetic 

16 change. You know, it has been going on for eons 

17 and we are still here and the planet is still here, 

18 and the trees are still here and the plants. So, 

19 I mean, Nature does have control also. Even I 

20 think of some of the genetically-engineered crops, 

21 we haven't seen them take over the planet.

22 I mean, I think we don't want to panic 
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1 about all this because we have been breeding plants 

2 for hundreds -- in fact, maybe even longer than 

3 that. Teosinte, you know, we came from teosinte 

4 to maize now. Maize hasn't taken over the planet.

5 So, I think we have to have a little bit 

6 of faith that Nature does exercise control over 

7 these things. Usually, mutated species have 

8 negative aspects to the mutation. The mutations 

9 are generally negative, and they don't last in the 

10 environment.

11 So, let's sort of take it in the context 

12 of what our experience has been over the millennia 

13 that we have had all these genetic mixing and 

14 changes going on naturally through natural 

15 radiation, through natural mutations, et cetera, 

16 et cetera.

17 DR. HANSEN: Well, I would just add to 

18 that, though, my take on it is slightly different; 

19 that, yes, these things have happened in Nature and 

20 there's ways to select against them. But there are 

21 so many examples. I can think of hundreds of 

22 chemicals and other things that were considered 
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1 perfectly benign at the time, that we then release, 

2 and now we have -- for example, we have global 

3 programs to deal with persistent organic 

4 pollutants that were all developed originally by 

5 humans thinking that they knew better and that 

6 these were perfectly safe compounds. We do this 

7 over and over again.

8 And I would just argue that it is one 

9 thing if Nature produces something that is 

10 damaging. To try to mitigate those aspects. It 

11 is something fundamentally different than when a 

12 human does it and is trying to make profit or do 

13 something with it. There is an intentionality 

14 there that there isn't necessarily there in Nature. 

15 That is why I think we have to be much more careful 

16 about the human intervention in things, because it 

17 is something fundamentally different than when 

18 Nature is doing it.

19 DR. GOULD: Right. We are certainly 

20 helping corn take over the planet.

21 But one of the things that I think is 

22 important for this body, and I understand the need 
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1 to come to some conclusion on this proposal in the 

2 near future, to get us to someplace where we can 

3 take some action. I think that is really 

4 important, but we have to understand this is still 

5 in constant flux. So, even when this proposal is 

6 passed and rules are enacted for it, that is not 

7 the end of the story by a long shot. This body is 

8 probably going to have to retake up or continue the 

9 discussion in whatever the next forward-thinking 

10 phase of it is, depending on how the development 

11 and the presence of these new varieties affect us.

12 MEMBER DE LIMA: Tom?

13 VICE CHAIR CHAPMAN: That was a good 

14 segue for my question. So, rules, ultimately, 

15 we're a standards Board. We make recommendations 

16 for regulations. From that perspective, how do we 

17 grapple with the concept of prohibiting practices 

18 that are not detectable through testing? Are 

19 there consequences, potentially, that we need to 

20 be thinking about?

21 DR. GOULD: Yes, there are 

22 consequences, as I said, especially if the National 
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1 Organic Program is left to itself to have to deal 

2 with the fact that it might not be able to detect 

3 things and somehow be responsible for things that 

4 are trespassed on it. And if there is not enough 

5 adequate regulatory support for the people or the 

6 people who are producing these organisms or 

7 releasing these organisms, it may be seen as 

8 somehow beyond the purview or the power of the 

9 National Organic Standards Board or the National 

10 Organic Program to influence the way in which the 

11 introduction of these new strains is made.

12 But I don't know how we are going to get 

13 beyond some of that responsibility. It can't be 

14 organic farmers. It can't be organic certifiers 

15 having to do certain things. There may be a 

16 certain amount of diligence that can be done, but 

17 the idea somehow that we don't use those things and, 

18 therefore, it is not our problem, we know that it 

19 doesn't completely work.

20 DR. HANSEN: Yes, and what I would say 

21 is I question whether those things will ever truly 

22 be untraceable because we live in a free market 
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1 system. And if somebody is going to develop a new 

2 product that they are going to sell and there is 

3 no way to detect it, they will have to have some 

4 way that they can detect it themselves to make sure 

5 that others aren't taking their property from them.

6 And I would point out, unless you want 

7 to spend lots of money, you could make some of the 

8 same arguments about organic right now. How can 

9 you tell whether someone has used a synthetic 

10 fertilizer unless you want to look at the isotope 

11 ratios in the harvested plants? But there are 

12 certain other things that you do via traceability 

13 mechanisms.

14 And I think the same could be done for 

15 many of these technologies because we will 

16 ultimately know where they are going to come from 

17 because somebody is going to be selling them and 

18 releasing them, and they are going to want to make 

19 sure that they get compensated for their products. 

20 If it is a product that nobody can detect any 

21 changes in it, then how would they prevent any of 

22 their competitors from just ripping off their own 
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1 product?

2 So, I think as long as we live in the 

3 market that we live in now, this free market, there 

4 are going to be ways to detect these things because 

5 it is in the interest of the people that developed 

6 them. If they want to, quote, "preserve" their 

7 intellectual and other property, there will be ways 

8 that they can detect them.

9 DR. GOULD: If I can add to that, I 

10 would say I would generally agree with that 

11 ingenuity in the market and the availability of 

12 things like sequencing technologies and 

13 supercomputing, and that sort of thing, will make 

14 it possible perhaps to identify species relatively 

15 quickly as to the differences between them. Now 

16 whether we can trace that to a specifically-induced 

17 mutation or one that naturally occurred is perhaps 

18 another story.

19 But one of the things that maybe I 

20 slightly would either disagree with or add to what 

21 Michael was saying is that it seems like what you 

22 were just talking about uses sort of the old model 
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1 that only a handful entities are going to have this 

2 technology and be able to release these kinds of 

3 organisms.

4 From my view, I see that changing to 

5 where it becomes far more possible for smaller 

6 entities to be able to -- you and I could buy 

7 sequencing technology and manipulation technology 

8 now. It is relatively cheap. It is relatively 

9 available.

10 If you know how to use it, there can be 

11 a lot smaller entities being able to start 

12 manipulating seeds or varieties and selling them 

13 or releasing them or trading them. And so, in that 

14 sense, that is going to be a disruption that we are 

15 not used to, and we don't have the regulations in 

16 place about who can do what in general.

17 I mean, it is just like when you get a 

18 license to -- who knows? -- you know, cut a tree 

19 down on your site. You've got to get a license from 

20 the city to do it. But we don't have that level 

21 of regulation because the technology is moving far 

22 faster than regulation is able to keep up with.
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1 MEMBER DE LIMA: All right. We are 

2 going to do one last question from Emily.

3 MEMBER OAKLEY: Well, on that note, in 

4 terms of the traceability and detectability, are 

5 there any methods that we have proposed as excluded 

6 now that you think would lead to immediate or 

7 short-term enforcement issues?

8 DR. SCORZA: You mean in technologies 

9 that are not excluded or would not be excluded, 

10 could they be detected?

11 MEMBER OAKLEY: Well, in this document 

12 in terms of the proposed excluded methods, if we 

13 were to go forward with this document shortly or 

14 within the short-term, are there any methods that 

15 are going to provide enforcement challenges?

16 DR. TRACY: Well, yes. I mean, this 

17 document has the FasTrack. No, the FasTrack is 

18 not. But the CRISPRs and the targeted genetic 

19 modifications are all listed as, yes, excluded. 

20 And those are precisely the ones we're talking 

21 about. There are other ones that probably would 

22 fall in the same place, but it will be the 
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1 gene-editing ones that will be the most problematic 

2 because they will be the most widely-used.

3 DR. SCORZA: But it seems like the 

4 organic industry could question a new product, a 

5 company, and say, "How did you develop this?" If 

6 they lied about it, that would be legally a very 

7 tough decision to make.

8 So, I think just the business practices 

9 or going to a business and saying, "How did you 

10 develop this new variety?", and they would have to 

11 make the decision, are we going to lie about this? 

12 So, I think human interaction and human trust is 

13 going to be part of this. We are talking about 

14 morality, and those enter in. We can't assume that 

15 all these companies are going to be immoral and do 

16 things that are going to hurt their customers or 

17 themselves.

18 So, I think part of that is going to come 

19 into, I think, the equation of just ask them, "How 

20 was this developed?" And that perhaps could --

21 DR. GOULD: Well, that may be true, but 

22 I can imagine the certifiers in the room are 
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1 potentially really squirming right now, thinking 

2 about the kinds of diligence that they may need to 

3 do with somewhat of an attitude of futility in a 

4 sense. Because even just getting a non-Big-Three 

5 declaration on a flavor sometimes is just pulling 

6 teeth or something which is a bit of a rubberstamp 

7 kind of thing.

8 And so, I think we need to think very 

9 carefully about where we are putting the onus of 

10 responsibility here.

11 DR. HANSEN: And I would, finally, say 

12 I do think sequencing technology, if it becomes 

13 faster and cheaper, I think there will be ways, even 

14 with stuff that is precisely edited, that if you 

15 have enough genomes to scan, you will be able to 

16 detect that something has happened. Because you 

17 can sort of look and see what has happened 

18 conventionally versus these manipulated ones. 

19 And I think you will see it will be very easy to 

20 see differences.

21 DR. TRACY: Yes, and just to give 

22 another example, but a totally legal one, if, as 
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1 some of us would like to see, utility-patented crop 

2 cultivars are excluded, that would mean that when 

3 the information for the certifier about where the 

4 seed came from, it would have to have a declaration 

5 on that seed certificate that it was a 

6 non-utility-patented item. And that would also 

7 really mean that all of the seed catalogs should 

8 actually have that as well. So, that is really 

9 kind of the same marketplace thing as opposed to 

10 a biological aspect.

11 MEMBER DE LIMA: So, I want to give each 

12 of you a chance -- we are running a little 

13 behind -- so about a minute to make any closing 

14 remarks you might have, starting with Dr. Gould.

15 DR. GOULD: I guess thanks again for 

16 allowing us to be part of this.

17 What I would say is I would be very 

18 interested in helping facilitate any kind of 

19 cross-pollination of this discussion with things 

20 on the other side of the Atlantic or globally within 

21 IFOAM.

22 And the other statement that I would 
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1 make is I would highly encourage USDA and people 

2 in the National Organic Program to do whatever they 

3 can to try to share the burden of addressing the 

4 complexity of this outside of this group and just 

5 the program itself.

6 DR. HANSEN: I think I have said most 

7 of the things I would like to say. But I would like 

8 to echo what you said, that I would urge USDA to 

9 be open in this whole process and try to get as many 

10 views as you can from the interested stakeholders.

11 And I would be more than willing to help 

12 look at anything that is done in the future on this, 

13 because I do think you're going to have to deal with 

14 a lot of technical details, and it should all be 

15 looked at.

16 And I wish you the best of work.

17 DR. TRACY: Yes, and I would basically 

18 echo that.

19 Thank you for having me here. It is a 

20 very interesting discussion.

21 I would offer to Zea and her 

22 Subcommittee help with this document. I've got a 
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1 lot of bright, young grad students who will have 

2 opinions and ideas. And we have some other folks 

3 in Wisconsin who are interested in this. So, just 

4 keep us in mind when you need something.

5 DR. SCORZA: I would like to say that 

6 I really appreciate being here, to be able to listen 

7 to the conversation and to meet everyone.

8 I think the breeders in general are all 

9 trying to develop products that are going to 

10 improve agriculture and improve the health and 

11 nutrition of the consumers. I think that is 

12 generally a goal of many breeding programs.

13 And I think the ability to discuss your 

14 needs, your philosophy on developing new crops with 

15 people who are looking at it from a different point 

16 of view is very, very important. So, I have found 

17 this time here very enlightening, very 

18 interesting.

19 And I think that you would find that 

20 more of these discussions will get us understanding 

21 each other more and moving in directions that we 

22 are both happy with. Sometimes we will go one way 
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1 and others will go another way, but I think knowing 

2 where we all stand on things is very helpful.

3 And I am really glad to have been 

4 invited here, and I appreciate the time. Thank 

5 you.

6 MEMBER DE LIMA: Well, thank you. We 

7 really appreciate all of you coming out and taking 

8 the time to spend with us, help us on this 

9 complicated issue.

10 Tracy?

11 (Applause.)

12 CHAIR FAVRE: Thank you, gentlemen.

13 Okay. We are going to take a 15-minute 

14 break. Then, we will come back here and begin the 

15 Materials Subcommittee discussions.

16 (Whereupon, the foregoing matter went off the record at 3:38 p.m. and 

17 went back on the record at 3:58 p.m.)

18 CHAIR FAVRE: Thanks, everybody, for coming back.

19 That was quite intellectually dense and meaty information and maybe 

20 challenging information after lunch. So, we appreciate your sticking with us. Fascinating 

21 information and it just points out how incredibly complex these issues are going to be, as we 

22 try to tackle them.
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1 So, first up on our agenda after the break is the Materials Subcommittee. 

2 I am going to turn that over to Lisa de Lima.

3 Lisa?

4 MEMBER DE LIMA: All right. So, we have got three topics, one 

5 proposal and two discussion documents. We are going to start with the excluded methods 

6 terminology proposal. I am going to hand it over to Zea.

7 MEMBER SONNABEND: Thank you, Lisa.

8 So, actually, all three documents are 

9 mine, and it is impossible to talk about the 

10 proposal really separating from the discussion 

11 document. So, we are going to cover aspects of 

12 each one.

13 We realized when we started this 

14 project, which is approximately three years ago 

15 now, that we had to come grips with the definition 

16 of "excluded methods" because it was quite, well, 

17 effective as far as it has gone so far in the rule. 

18 A lot of the terms in it were becoming outdated.

19 And we couldn't have individual 

20 discussions about all of the different topics that 

21 came before us, which have included in the past the 

22 animal vaccines and the cell fusion technique used 
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1 in brassicas. Discussing these technique one by 

2 one just didn't make sense unless we had an overall 

3 policy about excluded methods and what they meant 

4 and what criteria we are using to exclude them.

5 So, we started the process of examining 

6 the different terms in the definition and outside 

7 the definition to get a grip on what was out there 

8 and what we needed to do. After two previous 

9 versions of a discussion document, both of which 

10 were posted twice, you know, covering a period of 

11 two years, we have proceeded to the proposal stage.

12 This premise is somewhat based on the 

13 fact that the rest of the USDA we feel, not to 

14 mention the other agencies, is doing an inadequate 

15 job of regulating GMOs from an organic point of 

16 view. And so, if they are not going to regulate 

17 them properly, we are going to have to regulate them 

18 ourselves. So, that is pretty much what we are 

19 trying to do.

20 Before I get in, I am going to just 

21 briefly talk about the contents of the document and 

22 the public comment we have received, and open it 
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1 up to questions and comments from the Board.

2 I will say, at the outset of this, that 

3 we have decided we are not going to vote this 

4 proposal today. We will be sending it back to the 

5 Subcommittee because we appreciate the public 

6 comments we got that it is not quite ready for 

7 primetime.

8 Along with that, I will say that, while 

9 I do think the definitions are pretty close to being 

10 ready and a few suggestions were made for tweaks 

11 or elaborations which we don't consider 

12 substantive, the proposal doesn't hang together 

13 until we have the definitions and criteria in 

14 place, because the definitions and criteria are 

15 what set the framework for, then, looking at the 

16 individual terminology.

17 So, this was designed -- and I think 

18 some people somewhat misinterpreted this, and this 

19 was partially our fault because we made a tactical 

20 error -- but the proposal was only meant to cover 

21 definitions, criteria, and then, those segments of 

22 the terminology which was clear fell under excluded 
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1 methods by those definitions and criteria.

2 Then, there was another section which 

3 we put as TBD in the proposal, which are ones that 

4 we really needed to discuss in more detail later. 

5 And those ones were in the discussion document.

6 We probably shouldn't have put them in 

7 the proposal to start with and only kept them in 

8 the discussion document because I feel some people 

9 didn't understand and said that we had to wait until 

10 the whole chart was ready to go before we would put 

11 the proposal forward. And that was never the 

12 intent.

13 It is intended to be flexible. I would 

14 imagine that, for the next 10 years, some of those 

15 terms and additional ones that are suggested will 

16 still be being evaluated, but it is set up so that, 

17 once we have a structure, each time a new technique 

18 comes up we will be able to take it up with a clear 

19 set of benchmarks that we are measuring things 

20 against.

21 Okay. So, the definitions is the first 

22 section. As I mentioned, most of the comments were 
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1 to, for instance, elaborate by things that were 

2 already in the excluded methods definition, like 

3 "does not occur under natural conditions". I had 

4 taken it for granted that, because that is in the 

5 excluded methods, we didn't need to repeat it for 

6 an individual definition. We will take another 

7 look at that when we do send it back to Committee.

8 A few people were concerned that Codex 

9 versus the Cartagena Protocol. That really ends 

10 up just being a footnote rather than a substantive 

11 change. And there is, apparently, a one- or 

12 two-word difference between the definition we put 

13 out there which we borrowed from the NOP's own memo 

14 on cell fusion. And so, it may have had the 

15 incorrect word in there, but we will take that back 

16 and make the correct wording and the reference to 

17 Codex.

18 And then, some people wanted the 

19 definitions in a different order. And one or two 

20 people wanted us to get rid of the definition of 

21 "genetic engineering" altogether, which I'm not 

22 inclined to do because it is so in the vernacular 
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1 in so many of our other posted proposals, that I 

2 feel like anything that is in that vernacular 

3 really should be defined, so we know what we are 

4 talking about.

5 We also got a bit of input on 

6 elaborating on the non-GMO definition, which I 

7 think is good input, to reemphasize the process 

8 phased nature of what we do, and we can improve that 

9 when we take it back.

10 Then, finally, we got several comments 

11 about defining the clause in the law "traditional 

12 breeding," which some often call "classical 

13 breeding". And that seems like a very viable 

14 concern, and we will take a look at that to see if 

15 we are able to come up with that definition.

16 However, that is the kind of thing that, 

17 if it has to go beyond the fall, the next version, 

18 that we can continue working on it and come back 

19 later with more definitions, more criteria if we 

20 want, more evaluation.

21 Okay. Moving to the principles and 

22 criteria, everyone really liked the principles. 
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1 One or two people wanted to wordsmith what it says 

2 in the Policy and Procedures Manual, and I'm going 

3 to leave that to the Policy and Procedures 

4 Committee because they were really minor, and I 

5 don't feel like that is necessary to do. And it 

6 needs to be done there first before it would come 

7 into this document.

8 The IFOAM principles seemed to be 

9 unanimously acceptable to everyone, which is good 

10 because I am sure they spent many years and on a 

11 worldwide basis coming up with those principles.

12 And then, the criteria is the area that 

13 we need to do the most work. But, still, we had 

14 general support for the overall direction of the 

15 criteria. We had some wording suggestions. We 

16 will take a look at particularly the third 

17 criteria, which the novel proteins concept was not 

18 well-understood and needs to be clarified or 

19 perhaps moved to discussion, where it will be a 

20 later criteria. And the others, we can examine 

21 some wording changes to make everyone feel that 

22 they are a bit more complete.
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1 Now I will say, in case it wasn't 

2 completely clear from what David Gould said about 

3 alignment with IFOAM, in this document we have to 

4 balance the need for doing our own wordsmithing on 

5 everything to trying to make our language 

6 compatible with international norms and the 

7 international process.

8 That does not mean that we are going to 

9 wait for IFOAM to approve their new language at the 

10 end of the year, but it does mean that some of your 

11 changes which are suggested that will change 

12 otherwise internationally-accepted language we 

13 may not adopt because we feel that it is more 

14 important to be in alignment with the international 

15 community on this. We just will have to take a look 

16 at all of that.

17 Okay. So, that handles the principles 

18 and criteria in terms of what we will send back and 

19 take a look at. As far as the terminology chart 

20 today, I already mentioned that the TBD ones were 

21 not really meant to go into the proposal at this 

22 point.
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1 You know, each one of those TBD ones 

2 could have a whole paper on its own because many 

3 of them have more than one way to do the same thing, 

4 some of which might be genetic engineering and some 

5 of which might not. They have different 

6 applications, as we talked about, in animals, 

7 plants, insects, et cetera. And then, there is the 

8 whole issue of enforcement, which in some of those 

9 is quite problematic.

10 And so, those are going to be staying 

11 as TBD in our next version. They will be in just 

12 a discussion document and not in the proposal.

13 The only ones on the terminology chart 

14 that we got significant comment against including 

15 were the embryo transfer in animals. And so, we 

16 will also move that into the TBD category. We 

17 didn't do a good enough job explaining it or the 

18 reasoning why. I tried my best to encompass most 

19 of the things, but I couldn't do 100-percent 

20 thorough job on that, and that was one we rushed 

21 a bit.

22 And then, we did hear some input that 
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1 we will have to weigh about possible uses of CRISPR. 

2 If we decide to keep it on the chart, we will. If 

3 we decide to move it off, it will move into TBD and 

4 there will be another discussion document to 

5 solicit more input.

6 Okay. So, with that, I will open it up 

7 for questions or comments from the Board.

8 CHAIR FAVRE: Jean?

9 MEMBER RICHARDSON: It's hard to know 

10 really what to say about this, she says. I'm glad 

11 I don't have to pass an exam on cytology or 

12 cytogenetics this afternoon.

13 But I have been sitting in on the 

14 Materials Subcommittee as they have been going 

15 through the incredible hard work in putting this 

16 together. So, really, the main thing that I have 

17 to say is that I think that we have a 99-percent 

18 ready document for us to be able to vote on. Sorry 

19 we couldn't vote on it today, but, hopefully, we 

20 have something that we can vote on before Zea's term 

21 is up on the Board.

22 Zea, you have done an absolutely 
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1 astounding job, and everybody really appreciates 

2 it. And the panel just really added to this 

3 document, and to the hear the way in which it is 

4 widely accepted in the scientific community is just 

5 really impressive. So, thank you.

6 VICE CHAIR CHAPMAN: Are there any 

7 thoughts by members of the NOSB about how we can 

8 get that technical -- there was a call for a 

9 technical panel and stuff, and you had a great 

10 response to that, saying, "Tell me how I can do it 

11 in the next six months."

12 MEMBER SONNABEND: Yes. Well, I was 

13 actually planning to mention that, also. We do not 

14 have the ability to do anything like an official 

15 task force in a six-month period, if maybe at all. 

16 So, I would like to tell the members of the 

17 community, as it stands, I am happy to work with 

18 anyone who wants to provide input on this, but I 

19 do not have the ability to organize a scientific 

20 group or conduct conference calls or anything like 

21 that. But if any industry or NGO groups or anyone 

22 wants to organize this, I am happy to participate.
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1 And the way that we work on documents 

2 is we have to meet our Subcommittee deadlines, but 

3 this reverts back to me to make the changes. And 

4 I will submit it to the Subcommittee, which I have 

5 to do probably by sometime in mid-July. Until that 

6 time, until we turn it back over to the Subcommittee 

7 to rule, I can work with any task force or group 

8 that people want to organize, but I am relying on 

9 you to organize. Or you could give me individual 

10 feedback. But I would be happy to have a group 

11 organized in some fashion. And you heard our 

12 panelists, many of whom said they would like to 

13 participate in that also.

14 Anyone else?

15 A-dae?

16 MEMBER ROMERO-BRIONES: So, we had 

17 several comments that suggested we include an 

18 animal portion in this document. Is it possible 

19 for us to actually do a scan of the document to see 

20 how that may differ from what we have now?

21 MEMBER SONNABEND: Yes, we fully 

22 intend to do that and have intended to do it right 
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1 along. And a few of the things are specifically 

2 on there because of animals, because of the vaccine 

3 situation. But other of the criteria we borrowed 

4 from plant-breeding criteria, so they only say 

5 "plants". But we will go through it and we will 

6 make sure that it is universally-applied.

7 VICE CHAIR CHAPMAN: And I just want to 

8 follow up on the panelists about micro, about 

9 bacteria and fungi --

10 MEMBER SONNABEND: And 

11 microorganisms.

12 VICE CHAIR CHAPMAN: -- and finding 

13 someone that can -- I mean, I guess that kind is 

14 a callout to everyone to help us identify the right 

15 person to help us with that.

16 MEMBER SONNABEND: Uh-hum.

17 A-dae?

18 MEMBER ROMERO-BRIONES: We had several 

19 comments suggesting we find traditional plant 

20 breeding.

21 MEMBER SONNABEND: Uh-hum.

22 MEMBER ROMERO-BRIONES: So, to me, I am 
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1 having a hard time grappling with defining that, 

2 particularly coming from indigenous communities 

3 where traditional plant breeding is not always 

4 clearly defined in classic plant-breeding 

5 definitions. So, I would like to be included if 

6 that goes forward.

7 MEMBER SONNABEND: Yes, the organic 

8 plant-breeding community, of which Dr. Tracy was 

9 one representative, but there are a number of 

10 others who work with Organic Seed Alliance and 

11 others, are very much aware of the indigenous 

12 people's, they call it, participatory plant 

13 breeding. And we definitely hope to consult those 

14 efforts. And it might be challenging, but we can 

15 take a stab at doing that.

16 Okay. Then, I think that we will 

17 consider this --

18 VICE CHAIR CHAPMAN: I'll make the --

19 do you want me to -- yes?

20 MEMBER SONNABEND: Okay.

21 VICE CHAIR CHAPMAN: So, I move to 

22 refer the proposal back to the Subcommittee.
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1 CHAIR FAVRE: I have a motion. Do I 

2 have a second?

3 MEMBER SWAFFAR: Second.

4 CHAIR FAVRE: I have a motion from Tom 

5 and a second from Ashley. Is there any further 

6 discussion?

7 Yes, go ahead, Zea.

8 MEMBER SONNABEND: I forgot to make one 

9 point. We did get a couple of people who asked us 

10 to make positive standards instead, either organic 

11 plant-breeding standards or putting things on the 

12 National List. I feel that is not feasible at this 

13 time.

14 As far as the plant-breeding standards 

15 in detail, we have to have this in place first. And 

16 then, down the road, probably when I'm off the 

17 Board, some more detailed plant-breeding standards 

18 could be worked on. But, you know, I happen to know 

19 in Europe it has been discussed for 10 or 15 years, 

20 and they still do not have any standards in place.

21 CHAIR FAVRE: Any further discussion?

22 (No response.)
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1 Okay. We're going to do this via roll 

2 call, and we are going to start with Harold Austin 

3 and work our way around the table.

4 VICE CHAIR CHAPMAN: Now it's a simple 

5 majority.

6 CHAIR FAVRE: Yes, it is a simple 

7 majority to go back, to send it back to the 

8 Subcommittee.

9 So, Harold?

10 MEMBER AUSTIN: Yes.

11 MEMBER BUIE: Yes.

12 MEMBER BECK: Yes.

13 MEMBER SWAFFAR: Yes.

14 MEMBER ROMERO-BRIONES: Yes.

15 MEMBER DE LIMA: Yes.

16 VICE CHAIR CHAPMAN: Yes.

17 MEMBER SEITZ: Yes.

18 MEMBER BEHAR: Yes.

19 MEMBER SONNABEND: Yes.

20 MEMBER RICE: Yes, ma'am.

21 (Laughter.)

22 MEMBER RICHARDSON: Yes.
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1 MEMBER THICKE: Yes.

2 CHAIR FAVRE: Did we hear the last two 

3 down there?

4 MEMBER OAKLEY: You might not have, but 

5 we did say yes.

6 CHAIR FAVRE: The Chair votes yes.

7 MEMBER DE LIMA: That's 15 yes, zero 

8 no, zero abstain, zero recusals.

9 CHAIR FAVRE: Okay.

10 MEMBER SONNABEND: Seed purity?

11 CHAIR FAVRE: Yes, I was going to say 

12 next up on the -- go ahead.

13 MEMBER SONNABEND: Okay. I'll move 

14 into seed purity.

15 Okay. Those of you regulars know we 

16 have been working on this issue also for a number 

17 of issues. We have issued a few discussion 

18 documents and a report and another discussion 

19 document. We had an expert panel a year ago in San 

20 Diego.

21 We're airing a lot of the issues, and 

22 we are still not really there at the proposal stage. 
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1 So, this discussion document was kind of an attempt 

2 to throw everything at the wall and see if anything 

3 stuck.

4 (Laughter.)

5 No, I tried to synthesize all of the 

6 suggestions that had come in from all those years 

7 of public comment and, also, from talking to people 

8 about it at conferences and all over the place, and 

9 from the transcripts of our very informative expert 

10 panel that we had last year, to get some common 

11 themes that were always addressed, and then, to see 

12 if there was anything we could do about those 

13 themes.

14 We have heard back from a number of 

15 people, and I would have to say that people continue 

16 to think this is a very important subject and 

17 continue to help us, as we inch towards some 

18 activities that could lead us into the future on 

19 this.

20 So, we put out four definitive things. 

21 Unfortunately, we didn't get really a lot on Point 

22 E, which was like, "Give us a brand-new idea."
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1 But we did hear back on our four 

2 proposed suggestions, and many of the comments said 

3 all of these things could work in some kind of 

4 harmony together.

5 But the one that got the most positive 

6 support was the idea for a task force. Now I know 

7 there's like dueling task force requests on the 

8 NOSB in the future because a lot of people would 

9 like to have a task force and it is logical, so that 

10 we can involve some of the outside community in 

11 helping us make these tough decisions.

12 But this seems like one that could be 

13 ripe for a task force recommendation. And along 

14 with a task force, there's very much -- the whole 

15 issue of data needed is like just huge in this 

16 because people don't want to make decisions in a 

17 vacuum and they want to know where the 

18 contamination is coming from, what seed testing 

19 protocols would be, if any, and really keep someone 

20 to track, especially since the rest of the 

21 government is not tracking this at all, but all of 

22 the different varieties that are released that 
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1 would be genetically-engineered.

2 And if we do put forward the excluded 

3 methods proposal, this may even be more necessary 

4 to have some sort of a recording system, database, 

5 clearinghouse, or something. There are various 

6 mechanisms for this that could be explored, both 

7 through public and private funding potentially.

8 And so, a task force could help focus 

9 the activities and the timeline around this. And 

10 so, I am supportive of all these suggestions 

11 potentially. I hear from the certifiers that they 

12 don't feel like a certifier data collection one 

13 will work and there are real problems with that. 

14 It just seemed that certifiers or inspectors are 

15 already out in the field, and that would be perhaps 

16 a feasible way to do it, but I definitely hear all 

17 the concerns.

18 So, I think we very likely might come 

19 back -- and we haven't spoken about this in a 

20 committee, and I am interested in what my fellow 

21 Board members think -- but going forward with a 

22 recommendation for a task force in the future on 
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1 this subject might be worthwhile, because, as I 

2 mentioned, they could deal with the other aspects 

3 of it.

4 Also, in anticipation of when we put 

5 Item C in here, which was strengthening the organic 

6 seed requirements, so that there was more incentive 

7 for the organic seed companies to produce organic 

8 seed, I anticipated we would get a lot of supportive 

9 comment on this, which we did. We got quite 

10 extensive comment.

11 And therefore, at the same time we put 

12 this out, we put it into the request to be on our 

13 future work agenda for the Crops Committee to work 

14 on taking another look at the organic seed, what 

15 the NOSB passed, and what the USDA issued as 

16 guidance, and see ways that we could be 

17 strengthened. One of the first steps in that might 

18 be to see where the state is of organic seed usage.

19 So, that has been approved for the Crops 

20 Committee work agenda, and that will be working in 

21 tandem, then, with the Materials Subcommittee on 

22 this task force idea.
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1 MEMBER DE LIMA: Tracy?

2 CHAIR FAVRE: I would just like to 

3 comment that I do think a task force idea is a good 

4 idea. There's some work being done on the celery 

5 powder issue with a task force that is very 

6 collaborative in nature and it runs sort of the 

7 whole gamut from growers to processors, to the 

8 end-users, and trying to tackle it in a systems 

9 approach, which, obviously, is going to be required 

10 here.

11 I think if we can put something like 

12 that in place, we will have a much better chance 

13 of coming up with something, sort of having worked 

14 out some of the details of the issues across those 

15 different segments of the supply chain, if you 

16 will, before we try to tackle it within 

17 Subcommittee.

18 MEMBER DE LIMA: Tom?

19 VICE CHAIR CHAPMAN: Mine is a question 

20 for Miles. So, maybe let Miles go first. He might 

21 answer my question.

22 MR. McEVOY: You have a question? I 
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1 have an question, too.

2 VICE CHAIR CHAPMAN: Oh, okay.

3 (Laughter.)

4 MEMBER DE LIMA: Miles, go first.

5 MR. McEVOY: Okay. So, my question is 

6 about the task force. When I see this, I see maybe 

7 two different things that you are looking for. A 

8 task force is something that would be put together 

9 to prepare more information, a report to the Board, 

10 similar to what the Hydroponics/Aquaponics Task 

11 Force is doing. It is a collection of experts that 

12 are preparing additional information for 

13 consideration by the Board, for the Board, then, 

14 to have further recommendations on hydroponics and 

15 aquaponics.

16 But I also see that you want to look at 

17 testing or look at data or accumulate data, which 

18 would be, to me, a separate project. So, there are 

19 a couple of efforts going on around market 

20 surveillance in terms of gathering data. There is 

21 the California Department of Food and Agriculture 

22 that is doing some testing for GMOs. And then, we 
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1 have the Market Surveillance Program that we are 

2 initiating this year. We have resources 

3 potentially available to do additional testing, 

4 but it would have to be clear what it is that you're 

5 asking for.

6 So, to me, I'm seeing maybe two 

7 different concepts in this task force thing, unless 

8 I am misunderstanding.

9 MEMBER SONNABEND: Oh, I don't see it 

10 as two different concepts, and I don't see 

11 it -- like the data that we really need to identify 

12 first is whether contamination is coming from the 

13 seed or coming from pollen drift or coming from 

14 post-harvest handling. And that's not data that 

15 is being gathered by any of those other entities. 

16 I mean, it is just not marketplace data. It 

17 doesn't do that. The marketplace data collection 

18 is just, are you being contaminated? It doesn't 

19 ask where is it coming from.

20 So, I think it is I would like to have 

21 the task force grapple with how we can achieve the 

22 data needs that we are going to need. Because it 
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1 is sort of outside of our ability to do that type 

2 of finetuning.

3 MR. McEVOY: Okay. So, you see it as 

4 a two-step process, that the task force would sort 

5 of identify the methodology of what needs to be done 

6 to get the information? And then, the second step 

7 would be actually doing that work to get that 

8 information? And all that would, then, be 

9 provided to the NOSB for your further 

10 consideration? Okay. Thank you.

11 VICE CHAIR CHAPMAN: So, my question 

12 for you, Miles, is, how would such a thing be 

13 funded? Would that come out of the FACA budget for 

14 the NOSB? Or would that come under just other NOP 

15 funding mechanisms?

16 MR. McEVOY: That would come under 

17 separate funding sources. So, all the funding for 

18 this fiscal year has been obligated. We could look 

19 at ways of potentially funding this for the coming 

20 year.

21 MEMBER SONNABEND: Well, since this 

22 wouldn't come back until the fall, it will be the 
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1 next fiscal year for sure.

2 MR. McEVOY: Okay. If you're wanting 

3 this to happen, though, we start to obligate funds 

4 in October for the next year. So, the earlier we 

5 have this information clarifying what this request 

6 is, building a budget for what the financial needs 

7 are for this project would help.

8 MEMBER SONNABEND: We will start 

9 working on it right away.

10 MEMBER DE LIMA: Any other discussion 

11 on seed purity?

12 (No response.)

13 Okay. Seeing none, I think that 

14 concludes the Subcommittee.

15 CHAIR FAVRE: Thank you very much.

16 Okay. Next up is the Livestock 

17 Subcommittee, and I'm going to turn that over to 

18 Ashley Swaffar.

19 Ashley?

20 MEMBER SWAFFAR: So, this semester in 

21 the Livestock Committee our workload has been 

22 light. After sunset 2017, we appreciate the 
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1 breather that we had. But we did come out with a 

2 couple of very important proposals this semester, 

3 and I am really proud that we are trying really hard 

4 to advance animal welfare on organic farms.

5 For our next semester coming up, we will 

6 be reviewing several petition substances, 

7 including three poultry litter amendments on 

8 sulfur and we have begun working on a proposal for 

9 the Organic Poultry Working Group, which will 

10 support the resolution that this Board passed last 

11 year to phase out synthetic methionine in poultry 

12 rations.

13 Although this fall semester looks to be 

14 light for the Livestock Committee, we look forward 

15 to working together as a Committee to bring forward 

16 several actionable items many of our Committee 

17 members want to see accomplished. So, look for new 

18 and exciting things coming from the Livestock 

19 Committee. But, if 10 or so items somehow swim 

20 onto our agenda, we can handle those.

21 (Laughter.)

22 All right. First up for us is 
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1 hypochlorous acid petition proposal.

2 Francis?

3 DR. BRINES: Excuse me. Ashley, did 

4 you want me to introduce the petition?

5 (Laughter.)

6 MEMBER SONNABEND: And don't we have to 

7 do conflict-of-interest disclosures before we 

8 start inviting --

9 CHAIR FAVRE: Okay. I will give the 

10 Board an opportunity to make any 

11 conflict-of-interest declarations before we get 

12 started.

13 Zea?

14 MEMBER SONNABEND: Because I believe 

15 in transparent disclosures of conflict of 

16 interest, I would like to say at this time that I 

17 work for a certifier who may or may not certify any 

18 of the things that come before us on our agenda, 

19 but I do not have a personal financial gain from 

20 any of those things.

21 CHAIR FAVRE: Anybody else?

22 Scott?
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1 MEMBER RICE: I guess I would just say 

2 "ditto" to Zea's comment.

3 CHAIR FAVRE: And I should note that 

4 the Board members, when we have the final list of 

5 proposals coming before the Board at the meeting, 

6 we circulate a spreadsheet, and all the Board 

7 members have had an opportunity to examine that 

8 ahead of time and make a determination if there is 

9 any conflict of interest and indicate whether there 

10 is any question about that. At this time there 

11 were no conflicts of interest identified.

12 Harold?

13 MEMBER AUSTIN: I think after looking 

14 at all of the public comment that comes in, I would 

15 like to go ahead and declare and put into the public 

16 records, though, that in excess of over 30 years 

17 ago in a previous life, I did work for FMC, for a 

18 different division of FMC involved in the ag 

19 chemical, as a crop consultant years ago, in excess 

20 of over 30 years ago.

21 I'm assuming that we are doing this for 

22 everything or just for this?
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1 CHAIR FAVRE: Everything is fine.

2 MEMBER AUSTIN: Okay. So, looking at 

3 all the public comments, I just figured I should 

4 bring that forward.

5 CHAIR FAVRE: Thank you.

6 MEMBER AUSTIN: I could put into the 

7 record that they also took and fired myself and 

8 about 900 others.

9 CHAIR FAVRE: I believe you just did.

10 I believe we are waiting for Dr. Brines.

11 DR. BRINES: Are you ready? All 

12 right.

13 The one petition considered by the 

14 Livestock Subcommittee this round is for 

15 hypochlorous acid. This petition was submitted on 

16 May 29th, 2015 by Botanical Food Company.

17 The petition requested addition to 

18 Section 205.601 and Section 205.605 of the National 

19 List. However, the National Organic Program also 

20 asked the Livestock Committee to look at those uses 

21 for chlorine under the current listing for chlorine 

22 as well.
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1 In support of the review, a technical 

2 evaluation report was developed and was completed 

3 in 2015. And both the petition and technical 

4 report are available to the public on the NOP 

5 website.

6 The petition was submitted in response 

7 to a Policy Memo 14-3 that was published by the 

8 Program on June 9th, 2014. That Policy Memo has 

9 since been updated to Policy Memo 15-4 on September 

10 11th, 2015.

11 Thanks.

12 CHAIR FAVRE: Okay. Francis?

13 MEMBER THICKE: Thank you.

14 As Lisa mentioned, this will be voted 

15 on in three Subcommittees, Livestock, Crops, and 

16 Handling. And so, if I don't cover it properly, 

17 anybody from the other Committees, you can just 

18 jump and yell here because we will probably cover 

19 most of the meat of it now.

20 As Lisa mentioned, it was being used and 

21 being allowed on farms and handling operations. 

22 And then, there was some question about it, and a 
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1 petition came in.

2 And so, I wanted to kind, if this works 

3 here, to talk about what this really is. Already 

4 now, we have calcium and sodium hypochlorite that 

5 are on the National List, and hypochlorous acid was 

6 being used under that. But this is something that 

7 is made onsite with electrolyzed water.

8 If you look at the chart -- will this 

9 thing go that far? I guess I can't reach that far 

10 with it.

11 Okay. At the top it starts out with 

12 just distilled water or tap water and sodium 

13 chlorite. And then, the box in there is an 

14 electrolysis cell and it has a semi-permeable 

15 membrane in the middle. It pulls apart the water 

16 and the salt. And so, on one side you get protons 

17 and sodium, and then, on the other side you get 

18 hydroxyls and chlorine. And it goes further and 

19 makes the hypochlorous acid and, also, hydrogen

20 comes off. A little bit of hydrogen comes off. A 

21 little bit of oxygen comes off. So, it is made 

22 right onsite.
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1 And one thing about it is that it is not 

2 a stable chemical. It will dissipate over time 

3 back to its original components. So, that is one 

4 advantage of it.

5 Another advantage is that it is used at 

6 a very dilute level. And so, unlike sodium 

7 hypochlorite and calcium hypochlorite, it is used 

8 and it is less dangerous in that regard.

9 And if you look at the next slide, 

10 which -- oh, yes, so it is split apart. And on the 

11 left you can see the pH was very low -- there we 

12 go -- like 2 to 6, and that's acidic electrolyzed 

13 water. And on the right side, it is a high pH. 

14 This is more in line with the pH of bleach or sodium 

15 and calcium hypochlorite.

16 And then, the final product, you can 

17 actually combine those two and get the hydroxyl 

18 back in there to lower the pH to neutral. And then, 

19 you have neutral electrolyzed water.

20 If you look at this chart, this is 

21 pretty explanatory. It is that this is 

22 hypochlorous acid in the middle. That is the 
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1 middle pH. And this is the most effective 

2 sanitizing part.

3 Now the sodium and calcium hypochlorite 

4 are in this pH range, and it takes a higher 

5 concentration. Actually, the concentration is 

6 chlorine is about 10,000 times less at the 

7 concentration that it is being used as hypochlorous 

8 acid, which is a great advantage. And if you get 

9 too low on the pH, of course, you get down and you 

10 start blowing off chlorine on the low pH side. So, 

11 it is important that it is in the neutral side.

12 And that is why it is important that it 

13 is -- we have only looked at it as electrolyzed 

14 water. And we heard from somebody earlier in the 

15 comments that it can be made in other ways, and we 

16 have not evaluated those kinds of ways of making 

17 it. And so, in our annotation we are going to 

18 specify that it is made with electrolyzed water.

19 So, the advantages, then, are that it 

20 is manufactured on the site. And so, there aren't 

21 all the environmental and possibly health hazards 

22 that can go along with manufacturing some of these 
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1 hazardous chemicals and hauling them, transporting 

2 them, and so on.

3 It is short-lived. It will decay back 

4 to its original constituents, and it is used at a 

5 very low concentration.

6 So, those are the main points I think 

7 that I wanted to cover. And maybe if anybody else 

8 wants to add something on that -- yes, Jesse?

9 MEMBER BUIE: Now hypochlorous acid is 

10 a sanitizing agent, right?

11 MEMBER THICKE: Hypochlorous acid is a 

12 sanitizing agent, yes.

13 MEMBER BUIE: Which means it is going 

14 to have to be at, what, about 6?

15 MEMBER THICKE: Yes, about 6 to 7, in 

16 that pH range, that middle pH range. You can see 

17 it at that wide range where it is pretty active.

18 MEMBER BUIE: Okay.

19 MEMBER THICKE: I don't know. This 

20 thing, it sometimes goes and sometimes doesn't. 

21 Okay.

22 The blue line in the middle is where the 
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1 hypochlorous acid predominates. And so, as the pH 

2 changes, the species and solution changes. As it 

3 gets to a higher pH on the right, we lose the 

4 hypochlorous acid in favor of hypochlorite in 

5 solution. And as we go to the left, we lose the 

6 hypochlorous acid and it goes into chlorine 

7 predominates.

8 MEMBER BUIE: Right. Because there 

9 have been some studies where it was at 2.

10 MEMBER THICKE: I'm sorry?

11 MEMBER BUIE: I said there were some 

12 studies where they were using it at 2. Right? 

13 Okay. There were some studies where it was at 2.

14 MEMBER THICKE: pH 2?

15 MEMBER BUIE: Right. But, for our 

16 purposes, we want to just focus on --

17 MEMBER THICKE: Yes, in the central.

18 MEMBER BUIE: Okay.

19 MEMBER THICKE: And it is also, from 

20 what we have seen in the technical review, that is 

21 where it is most effective --

22 MEMBER BUIE: Right.
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1 MEMBER THICKE: -- as a sanitizer, and 

2 it can be done at the lowest concentration.

3 MEMBER BUIE: Okay.

4 MEMBER THICKE: Any other comments or 

5 questions?

6 (No response.)

7 MEMBER SWAFFAR: Ready for the 

8 classification motion.

9 MEMBER THICKE: Am I going to do that 

10 or --

11 MEMBER SWAFFAR: No, you do the 

12 classification.

13 MEMBER THICKE: Okay. Okay. Okay. 

14 So, the motion is to classify hypochlorous acid as 

15 synthetic.

16 CHAIR FAVRE: I have a motion from 

17 Francis. Do I have a second?

18 VICE CHAIR CHAPMAN: It comes from the 

19 Subcommittee.

20 CHAIR FAVRE: Oh, I'm sorry, yes.

21 VICE CHAIR CHAPMAN: Yes.

22 CHAIR FAVRE: You're right. This is 
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1 coming, as a reminder, which I needed, too, this 

2 is coming from the Subcommittee as a seconded 

3 motion, just as a reminder.

4 VICE CHAIR CHAPMAN: It's already 

5 seconded, yes.

6 CHAIR FAVRE: Sorry, that's right. 

7 So, we are bringing it forward.

8 So, we have the motion before the 

9 Subcommittee to classify it as a synthetic. Any 

10 more discussion?

11 (No response.)

12 Okay. Seeing none, we are going to 

13 start the vote, and we are going to star with Jesse.

14 MEMBER BUIE: Yes.

15 MEMBER BECK: Yes.

16 MEMBER SWAFFAR: Yes.

17 MEMBER ROMERO-BRIONES: Yes.

18 MEMBER DE LIMA: Yes.

19 VICE CHAIR CHAPMAN: Yes.

20 MEMBER SEITZ: Yes.

21 MEMBER RICHARDSON: Yes.

22 MEMBER BEHAR: Yes.
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1 MEMBER SONNABEND: Yes.

2 MEMBER RICE: Yes.

3 MEMBER OAKLEY: Yes.

4 MEMBER THICKE: Yes.

5 MEMBER AUSTIN: Yes.

6 CHAIR FAVRE: The Chair -- oh, excuse 

7 me -- the Chair votes yes.

8 MEMBER DE LIMA: That's 15 yes, zero 

9 no. The motion passes.

10 MEMBER SWAFFAR: Thanks.

11 Tom?

12 VICE CHAIR CHAPMAN: So, the motion 

13 from the Subcommittees for the placement of this 

14 item on the National List is not explicit enough, 

15 and we do want it to be the same across all 

16 Subcommittees. The petition, the Subcommittee 

17 review, and the technical review were all for 

18 hypochlorous acid generated via electrolyzed 

19 water.

20 Therefore, I move to amend the motion 

21 at hand to read, "hypochlorous acid generated via 

22 electrolyzed water as petitioned".
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1 MEMBER RICHARDSON: Second.

2 CHAIR FAVRE: I have a motion from Tom 

3 and a second by Jean. Any discussion?

4 Francis?

5 MEMBER THICKE: I forgot to mention 

6 earlier about some of the comments. And I wanted 

7 to put on the record that we had some comments 

8 suggesting that we really need to do a 

9 comprehensive review of sanitizers, in light of 

10 bringing hypochlorous acid in. I think we have 

11 talked about that in the past, that we need to look 

12 at all the sanitizers. We look at where it is 

13 required by law and what is the efficacy against 

14 various agents that need to be sanitized, and so 

15 on.

16 So, I wanted to put that on the record. 

17 I think that is something that we should pursue in 

18 the future.

19 VICE CHAIR CHAPMAN: Yes, and just for 

20 clarity, this motion is to amend and, then, after 

21 this motion, pass or fail the motion. The main 

22 motion still sits and will need to be voted on as 
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1 well.

2 MEMBER DE LIMA: Harold?

3 MEMBER AUSTIN: I would just like to 

4 add to the conversation for the amendment to the 

5 motion that we originally, throughout the various 

6 Subcommittees we did have hypochlorous acid and, 

7 then, in parenthesis "(electrolyzed water)". We 

8 removed that because we thought at one point it was 

9 going to be too restrictive. But, as we have gone 

10 through the deliberations and we have looked at 

11 public comments, we felt that having that part of 

12 that annotation is part of it, because that was the 

13 original intention and that was how this was 

14 petitioned. So, we felt that this was a better way 

15 to move with it.

16 And so, that is why we are looking to 

17 put this back in across all three Subcommittees for 

18 clarity and transparency, and then, having 

19 everything equal throughout all of the 

20 Subcommittees with the material that is on the 

21 National List, if it is approved.

22 CHAIR FAVRE: We've had the question 
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1 called by Jean.

2 Do I have a second?

3 MEMBER SWAFFAR: Second.

4 CHAIR FAVRE: Okay. So, we have a 

5 motion to amend the motion. So, we will start with 

6 the vote on that with Carmela.

7 MEMBER BECK: Yes.

8 MEMBER SWAFFAR: Yes.

9 MEMBER ROMERO-BRIONES: Yes.

10 MEMBER DE LIMA: Yes.

11 VICE CHAIR CHAPMAN: Yes.

12 MEMBER SEITZ: Yes.

13 MEMBER RICHARDSON: Yes.

14 MEMBER BEHAR: Yes.

15 MEMBER SONNABEND: Yes.

16 MEMBER RICE: Yes.

17 MEMBER OAKLEY: Yes.

18 MEMBER THICKE: Yes.

19 MEMBER AUSTIN: Yup.

20 MEMBER BUIE: Yes.

21 CHAIR FAVRE: The Chair votes yes.

22 MEMBER DE LIMA: It's 15 yes, zero no. 
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1 The motion passes.

2 CHAIR FAVRE: Okay. Now we've voted 

3 on the amendment to the motion for listing. So 

4 now, we have the amended motion which we have to 

5 vote on as a Board.

6 MEMBER SWAFFAR: Tracy, first, we need 

7 to ask if there is any further discussion on the 

8 motion.

9 CHAIR FAVRE: I was just explaining --

10 MEMBER SWAFFAR: Oh.

11 CHAIR FAVRE: -- to make sure that 

12 we're all clear on what we're doing here before we 

13 get started on the vote.

14 MEMBER SWAFFAR: Yes.

15 CHAIR FAVRE: Go ahead.

16 MEMBER SWAFFAR: Great. Any other 

17 discussion that we need to have?

18 (No response.)

19 Great.

20 CHAIR FAVRE: Okay. We have a motion 

21 on the Floor to accept the amended motion. Did 

22 that make sense? So, we will start that voting 
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1 with -- who are we up to? -- Ashley.

2 MEMBER SWAFFAR: Yes.

3 MEMBER ROMERO-BRIONES: Yes.

4 MEMBER DE LIMA: Yes.

5 VICE CHAIR CHAPMAN: Yes.

6 MEMBER SEITZ: Yes.

7 MEMBER RICHARDSON: Yes.

8 MEMBER BEHAR: Yes.

9 MEMBER SONNABEND: Yes.

10 MEMBER OAKLEY: Yes.

11 MEMBER THICKE: Yes.

12 MEMBER AUSTIN: Yes.

13 MEMBER BUIE: Yes.

14 MEMBER BECK: Yes.

15 MEMBER DE LIMA: That's 15 yes, zero 

16 no. The motion passes.

17 CHAIR FAVRE: The Chair votes yes.

18 MEMBER DE LIMA: Oh, sorry.

19 (Laughter.)

20 CHAIR FAVRE: So now, yes, the same 

21 vote.

22 MEMBER SWAFFAR: Great. Thank you.
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1 Up next we have Jean with the 

2 parasiticides.

3 MEMBER RICHARDSON: Yes, lidocaine. 

4 Lidocaine and procaine.

5 MEMBER SWAFFAR: Right, lidocaine. 

6 Great.

7 MEMBER RICHARDSON: So, if you would 

8 just bring it to, Michelle, just bring it up to 

9 where the vote is, you know, the motions.

10 So, what we have here is a motion to 

11 shorten the withholding period for the use of two 

12 local anesthetics, lidocaine and procaine, 

13 recognizing that in the U.S. we virtually never use 

14 procaine, but it is still there on the list. So, 

15 both lidocaine and procaine, lidocaine commonly 

16 used; procaine, almost never.

17 And so, we have two motions that we will 

18 look at in order to be able to shorten the 

19 withholding period from 90 days to eight days after 

20 administering to livestock consented for slaughter 

21 and six days after administering to dairy animals, 

22 these numbers representing double the FARAD.
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1 So, this began to develop as a topic 

2 based on public comment early last year, when we 

3 began the process of reviewing these materials for 

4 sunset. And we, obviously, received public 

5 comment during two different periods last year. 

6 We floated a discussion document in full in order 

7 to see if the idea of reducing these withholding 

8 periods was something for which there was a general 

9 positive approval or consensus amongst a broad 

10 range of stakeholders. And that is, indeed, what 

11 we found.

12 We found that there was a broad support 

13 for getting consistency in the way in which we deal 

14 with these types of materials. And we found that, 

15 with one minor glitch, which I will get to in a 

16 minute or two, that there was very broad 

17 stakeholder approval for making these changes when 

18 we floated both the discussion document and, then, 

19 subsequently, this proposal which you have before 

20 you today.

21 It is recognized both here and in the 

22 EU that there are no suitable alternatives to 
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1 lidocaine, and lidocaine, of course, is also 

2 commonly used directly on humans.

3 Consumers definitely want to see their 

4 animals treated humanely, and we have, as you heard 

5 again today, strong support from the American 

6 Society for the Prevention of Cruelty to Animals 

7 and from the Humane Society, that they are really 

8 delighted to see us moving forward for humane 

9 treatment of animals. Because, as you know, if 

10 there is a lengthy withholding, sadly, there will 

11 be times when, even though they are not supposed

12 to, treatment may be withheld from the animal 

13 because of the cost involved to the farmer of not 

14 being able to deal with that animal as it was 

15 intended.

16 In 2007, as you recall, there was a 

17 great deal of public comment, and it was agreed that 

18 the NOSB could require double FDA or double the 

19 Federal Animal Drug Residue Avoidance and 

20 Databank, FARAD, withholding times for livestock 

21 materials. And so, this proposal you see now will 

22 bring us up with the consistency, which is 
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1 particularly important. Consistency is very 

2 important across the organic standards.

3 And we have support from a wide range 

4 of certifiers, of groups of organic dairies. 

5 NODPA, for example, represents 11 different states 

6 in the Northeast. We have veterinarians, public 

7 interest groups, farms, et cetera, supporting 

8 this.

9 We did have a comment that raised some 

10 concerns very recently out of this present bunch 

11 of comments. The European Medicines Agency 

12 Assessment that came out, I think it was last 

13 year -- I don't have it right in front of 

14 me -- indicated that there could be some concerns, 

15 human health concerns, for the consumption of meats 

16 from the use of the lidocaine. And several of us 

17 on the Livestock Committee as well as staff in the 

18 NOP looked at these documents in some detail in 

19 order to clarify exactly what they meant.

20 The Assessment from the European study 

21 indicated that there was a non-detect in milk 48 

22 hours after injection and a non-detect in muscle 
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1 meat at 48.5 hours post-injection. And their 

2 recommendation for horse meat was that there could 

3 be zero withholding for horse meat; for slaughter 

4 cattle, 28 days, and milk, 15 days, but that some 

5 countries may legally opt out of the recommendation 

6 and, for example, just have zero days for milk and 

7 24 hours for slaughter, such as Norway.

8 However, when we looked at the fine 

9 detail when non-detect began to occur and the 

10 metabolites of lidocaine that were being measured, 

11 we determined that we would stick with the FARAD 

12 withholding periods that we had worked on, based 

13 on all the research that we have looked at in the 

14 last year, and that if, in fact, the NOP decides 

15 that it wants to do anything further with this 

16 recent European study, then we would come back and 

17 relook at what had been proposed, assuming that 

18 FARAD changed their recommendations based on this 

19 study.

20 So, we continue to recommend from the 

21 Subcommittee, and this came as a unanimous proposal 

22 from the Subcommittee, that we support these 
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1 changes that are suggested here today.

2 Yes, if you could float it up to the 

3 dates?

4 So, you see there the days up there. We 

5 are changing it from the 90 days, for which we found 

6 no scientific reason, to the eight days, which 

7 double the FARAD for slaughter, and the six days, 

8 instead of seven days, which is double the FARAD 

9 for dairy animals.

10 And this comes as a seconded motion.

11 Discussion?

12 And, Francis, do you want to add 

13 anything more?

14 MEMBER THICKE: Yes, if I could. On 

15 the European study, it suggested, and it should be 

16 clear, that they said 45 days for the last molecule 

17 of lidocaine to be cleared.

18 MEMBER RICHARDSON: Right.

19 MEMBER THICKE: First of all, it was a 

20 model, not an empirical measurement. And 

21 secondly, we don't ever really hold anything to the 

22 last molecule. Usually, the detection limit is 
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1 about 1 part per billion, and if you calculate it, 

2 you got about 10 to the 15th molecules at that 

3 point, or quadrillion. And so, if you are going 

4 to wait to the last molecule, we probably wouldn't 

5 have anything left on our Livestock Materials List, 

6 I think.

7 MEMBER RICHARDSON: Are there other 

8 questions, comments?

9 I think we might be ready for the 

10 question.

11 CHAIR FAVRE: We have a motion before 

12 the Board -- it came as a seconded motion -- to make 

13 an annotation change for -- yes, we are going to 

14 do these as separate votes for everybody. So, 

15 everybody knows, we will vote on each of the 

16 motions, even though they are essentially the same 

17 as far as the change goes or the intent behind it.

18 So, the first one is for lidocaine. Do 

19 you want to read the motion? Yes.

20 MEMBER RICHARDSON: Read it into the 

21 record. The first motion is that the deleted 

22 language be removed and the underlined 
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1 language -- is that what I am reading? Yes -- the 

2 underlined language be added at 205.603(b) as 

3 topical treatment, external parasiticide or local 

4 anesthetic, as applicable.

5 No. 4, lidocaine is a local anesthetic. 

6 Use requires a withdrawal period of eight days 

7 after administering to livestock intended for 

8 slaughter, six days after administering to dairy 

9 animals.

10 CHAIR FAVRE: Okay. We have a motion 

11 from Jean and a second from Francis out of 

12 Committee. Is there any further discussion?

13 (No response.)

14 Okay. We will start the vote with 

15 A-dae.

16 MEMBER ROMERO-BRIONES: Yes.

17 MEMBER DE LIMA: Yes.

18 VICE CHAIR CHAPMAN: Yes.

19 MEMBER SEITZ: Yes.

20 MEMBER RICHARDSON: Yes.

21 MEMBER BEHAR: Yes.

22 MEMBER SONNABEND: Yes.
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1 MEMBER RICE: Yes.

2 MEMBER OAKLEY: Yes.

3 MEMBER THICKE: Yes.

4 MEMBER AUSTIN: Yes.

5 MEMBER BUIE: Yes.

6 MEMBER BECK: Yes.

7 MEMBER SWAFFAR: Yes.

8 CHAIR FAVRE: The Chair votes yes.

9 MEMBER DE LIMA: That's 15 yes, zero 

10 no. The motion passes.

11 MEMBER RICHARDSON: The second motion 

12 is essentially the same as the first, but deals with 

13 procaine. And it reads that, "The deleted 

14 language be removed, the underlined language be 

15 added, at 205.603(b) as topical treatment, 

16 external parasiticide, or local anesthetic, as 

17 applicable.

18 (7), procaine, as a local anesthetic. 

19 Use requires a withdrawal period of eight days 

20 after administering to livestock intended for 

21 slaughter and six days after administering to dairy 

22 animals.
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1 CHAIR FAVRE: Okay. Any further 

2 discussion?

3 (No response.)

4 Okay. This time we will start the vote 

5 with Lisa.

6 MEMBER DE LIMA: Yes.

7 VICE CHAIR CHAPMAN: Yes.

8 MEMBER SEITZ: Yes.

9 MEMBER RICHARDSON: Yes.

10 MEMBER BEHAR: Yes.

11 MEMBER SONNABEND: Yes.

12 MEMBER RICE: Yes.

13 MEMBER OAKLEY: Yes.

14 MEMBER THICKE: Yes.

15 MEMBER AUSTIN: Yes.

16 MEMBER BUIE: Yes.

17 MEMBER BECK: Yes.

18 MEMBER SWAFFAR: Yes.

19 MEMBER ROMERO-BRIONES: Yes.

20 CHAIR FAVRE: The Chair votes yes.

21 MEMBER DE LIMA: It's 15 yes, zero no. 

22 The motion passes.
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1 MEMBER SWAFFAR: Great. Thanks, 

2 Jean.

3 Do you want to move on to parasiticides 

4 now?

5 MEMBER RICHARDSON: The parasiticide 

6 proposal.

7 Why don't you roll initially just down 

8 to the bottom of the first page there, Michelle, 

9 where it lists what the proposal is recommending? 

10 That way, we are clear what it's not recommending.

11 And so, you can see here just in sort 

12 ordinary laymen's terms what it is that we are 

13 recommending. It is very important to note the 

14 following things:

15 That we are not changing the 

16 prohibition of parasiticides in slaughter stock. 

17 It will still be prohibited, which, again, makes 

18 us a much higher standard than in the rest of the 

19 world for organics. That is not changing.

20 Before I get to the next one, let me just 

21 say two other things. One is that we are working 

22 here with the goal of immediately starting work on 
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1 what is the definition of "emergency". Because, 

2 as we all know, the parasiticides can only be used 

3 as a last resort, as an emergency. And I keep 

4 repeating this because everyone assumes that we are 

5 going to immediately have -- not everyone -- but 

6 some would assume that we are immediately going to 

7 have systemic or a constant use or a prophylactic 

8 use of parasiticides. That is not allowed to take 

9 place under our rule.

10 And we will be working in the 

11 Subcommittee, taking up as a work agenda item what 

12 is the definition of "emergency" and how will it 

13 be dealt with. And you heard some comment on that 

14 today in oral comment, and we will be working on 

15 that and, hopefully, come right back with a 

16 proposal. Hopefully, Harriet will be working on 

17 that in the Subcommittee to bring forward a 

18 proposal for the fall. Because we take those 

19 comments that we got from the public very 

20 seriously.

21 The other thing to be sure that we 

22 understand before we sort of continue going through 
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1 this is that the Subcommittee is adamant that we 

2 should remove, have a motion, have a petition to 

3 remove ivermectin, based on all of the research 

4 that we have heard over the last year-and-a-half, 

5 as we have been working through sunset, followed 

6 by discussion documents, followed by this 

7 proposal.

8 So, we still feel that very strongly, 

9 even though I know this has the potential to 

10 negatively impact some producers. We will be 

11 bringing forward a petition to do this again for 

12 the fall meeting.

13 And as you recall, the reason why we 

14 didn't throw it all in together is that we need to 

15 be sure that there's notice out there that those 

16 people that have been typically using only 

17 ivermectin have the opportunity to be able to get 

18 access to fenbendazole and moxidectin, and start 

19 experimenting to see what parasiticides as needed 

20 in an emergency may be as effective for them. That 

21 way, we will get some good comparative feedback, 

22 we hope, on ivermectin as we go through the next 
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1 piece of our work.

2 So, this is a pretty critical thing that 

3 we are doing here today, and I do believe it is very 

4 important for humane treatment of animals.

5 We are recommending that it still is 

6 prohibited in slaughter stock, but that the milk 

7 withholding period after treatment with 

8 fenbendazole and moxidectin be changed from the 90 

9 days, for which we could find no scientific reason 

10 why it had been started in the first place, to two 

11 days for dairy cows and 36 days for goats and sheep, 

12 based on the science as it is at the present and 

13 the FARAD levels. These are double the FARAD 

14 levels.

15 You will recognize, of course, that for 

16 goats and sheep we are working with -- you have to 

17 look at the weight of the animal, and so forth, in 

18 order to determine the withholding period. So, it 

19 is different for goats and sheep than it is for 

20 dairy cows.

21 The next item is that the listing for 

22 ivermectin is not changing on this. It is not 
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1 changing. So, you still have that 90-day 

2 withdrawal period for the ivermectin. That hasn't 

3 changed and we're not recommending that it change.

4 The next thing that the proposal is 

5 doing is we are moving moxidectin from to be used 

6 for both internal and external use because it was 

7 incorrectly listed in the original listing for a 

8 number of reasons which are listed in the lengthy 

9 document which I assume we have all read.

10 The next aspect of this proposal is that 

11 we would allow fleece and wool from fiber-bearing 

12 animals to be allowed to be certified organic, even 

13 if parasiticides had been necessary at some point 

14 in the animal's life. And we will look at the 

15 details in that motion in a minute or two.

16 And the next thing that we have done is 

17 that we are recommending or proposing that 

18 fenbendazole be allowed without the written order 

19 of a veterinarian. As you know, ivermectin is 

20 available over the counter. Fenbendazole, it sort 

21 of varies, but pretty much you've got to have a 

22 veterinarian.
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1 Okay. Let's see. We received 

2 extensive comment on these recommendations that we 

3 are proposing, both in the fall when we did the 

4 discussion document and, also, for this proposal 

5 here that is before us today.

6 By and large, we have very strong 

7 support from around the country from all 

8 stakeholders. Several organizations recommended 

9 that we shape up and get a good definition of 

10 "emergency use," and we have taken that very 

11 seriously, and we will, indeed, be doing that. 

12 They were supportive, but wanted to have emergency 

13 use attended to.

14 We have one group that wanted us to send 

15 it back to Subcommittee because they wanted to have 

16 ivermectin and moxidectin removed and have it go 

17 back for further work at Subcommittee. I believe 

18 that we will be able to address the ivermectin issue 

19 in our fall motion to remove, or petition to remove, 

20 I mean.

21 One organization and one farm which is 

22 part of that organization was recommending that we 
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1 not approve this, but we got broad support from 

2 organizations which believe that the humane 

3 treatment of animals is really going to be 

4 addressed by making sure that in emergency 

5 situations that animals can receive treatment and 

6 that withholding treatment from the animals just 

7 because of the fact that 90 days without milk, for 

8 example, as we heard from the veterinarian this 

9 morning, would have a serious economic impact on 

10 the farmer, but the animal, of course, is suffering 

11 in the meanwhile.

12 And again, a reminder that we expect all 

13 the certifiers to be ensuring that all farms that 

14 you are certifying and the inspectors that go to 

15 it are verifying that there is, in fact, a parasite 

16 control plan in place, and that that plan is 

17 actually being followed, and that it includes 

18 careful management of the pasture, the grazing 

19 periods, whether it is wet or dry conditions, all 

20 those things which we know are really good for 

21 management.

22 We recognize that there are many farms 
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1 that don't use any parasiticides at all at any 

2 point, and especially dairy farms, but that it can 

3 be a challenge for farms that are dealing with sheep 

4 or with goats.

5 Let's see. I think that is sort of 

6 basically all I need to say.

7 But, then, is there anything you want 

8 to add, Francis? You worked on this as well. No? 

9 Okay. Francis had nothing to add.

10 So, questions from anybody on this 

11 before we -- yes?

12 MEMBER BEHAR: Are you planning on 

13 changing the fiber-bearing animal wording?

14 MEMBER RICHARDSON: The motion, when I 

15 get to that, yes.

16 MEMBER BEHAR: Okay.

17 MEMBER RICHARDSON: Definitely. 

18 Thank you for reminding of that. Yes.

19 MEMBER DE LIMA: Emily?

20 MEMBER OAKLEY: This is more a comment, 

21 but I am just looking forward to the ivermectin 

22 proposal this fall.
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1 MEMBER RICHARDSON: Yes, we all are.

2 CHAIR FAVRE: Tom?

3 MEMBER RICHARDSON: Sorry.

4 VICE CHAIR CHAPMAN: Me? So, just to 

5 clarify, we are going to vote on all five of these 

6 individually? The first one is just about 

7 removing the listing on dairy and milk and moving 

8 into the National List, right?

9 MEMBER RICHARDSON: Yes. We have 

10 five.

11 VICE CHAIR CHAPMAN: Yes.

12 MEMBER RICHARDSON: So, in order to 

13 accomplish this wonderful thing, because of the way 

14 in which the rule is written, all the bits of it, 

15 if we could turn to the first motion, Michelle? 

16 And we will go through each of them, and I will say 

17 a little bit about each of them before we vote on 

18 it.

19 Okay. The first motion: "that the 

20 strikethrough language be removed and the 

21 underlined language" -- and these come, I should 

22 say these come as they are all unanimous motions, 
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1 seconded motions, coming from the Subcommittee, 

2 each of them the same.

3 So, the first motion is "to make change 

4 at Section 205.203(b)(2), dairy animals". And 

5 then, we delete "stock" "when used a minimum of 90 

6 days prior to production to milk or milk products 

7 that are sold, labeled, or represented as organic". 

8 Instead, we just have "as allowed under 205.603".

9 So, this is doing two things. It is 

10 simplifying what it is we're voting on right now, 

11 and it is sort of referring us from 238(b) to 

12 603(a), sort of tying those two pieces of the rule 

13 together.

14 And so, then, it goes on to say, "and 

15 at 205.603(a)(18)," it deletes all of that. It is 

16 just a sort of tidying up of what's in the rule. 

17 So, in a way, if you haven't gone into it in minute 

18 detail as I did for a period of time, driving me 

19 crazy, it has been verified by the NOP that this 

20 is the correct way to do it. I did work with staff 

21 to make sure that, when we come up with a motion, 

22 that it would be something that could function and 
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1 work in rulemaking.

2 So, we are voting on this whole thing 

3 as written up there and as I just read out.

4 Any questions on that motion?

5 Yes, Dan?

6 MEMBER SEITZ: So, 205.603, is that 

7 where the time is --

8 MEMBER RICHARDSON: Parasiticide, 

9 yes. Right.

10 MEMBER SEITZ: -- is that double the 

11 FARAD time limited?

12 MEMBER RICHARDSON: Yes.

13 MEMBER SEITZ: Okay. Thanks.

14 CHAIR FAVRE: Okay. Francis, go 

15 ahead.

16 MEMBER THICKE: I think just to clarify 

17 it, 238 is where the standard is and 603 is where 

18 the list is, so people understand that, you know, 

19 because it is confusing.

20 CHAIR FAVRE: Okay. Ready to vote? 

21 Okay. The voting will start with Tom.

22 VICE CHAIR CHAPMAN: Yes.
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1 MEMBER SEITZ: Yes.

2 MEMBER RICHARDSON: Yes.

3 MEMBER BEHAR: Yes.

4 MEMBER SONNABEND: Yes.

5 MEMBER RICE: Yes.

6 MEMBER OAKLEY: Yes.

7 MEMBER THICKE: Yes.

8 MEMBER AUSTIN: Yes.

9 MEMBER BUIE: Yes.

10 MEMBER BECK: Yes.

11 MEMBER SWAFFAR: Yes.

12 MEMBER ROMERO-BRIONES: Yes.

13 MEMBER DE LIMA: Yes.

14 CHAIR FAVRE: The Chair votes yes.

15 MEMBER DE LIMA: So, 15 yes, zero no. 

16 The motion passes.

17 MEMBER RICHARDSON: So, if we can 

18 scroll, then, to the second motion that we have, 

19 "that the underlined language be added at 

20 205.238(b)(3), fiber-bearing animals, as allowed 

21 under Section 205.603; and at 205.603(a)(18), 

22 allowed for fiber-bearing animals when used a 
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1 minimum of 90 days prior to" -- and the word 

2 "production" I'm going to talk about in a 

3 second -- "of fleece or wool that is to be sold, 

4 labeled, or represented as organic."

5 I would like to clarify what we mean by 

6 "production". We did receive public comment that 

7 wanted us to provide clarification for that word 

8 "production" to say, does that mean just the time 

9 when you're cutting fleece?

10 So, what we intend by that, as we go 

11 through rulemaking, sort of a message to the NOP, 

12 is harvest, whether that is shearing or plucking 

13 the wool -- well, I don't know whether you do that 

14 to goats, do you? Yes, I guess you do, for some 

15 goats you do.

16 So, the intention is that 90 days prior 

17 to shearing the sheep, or whatever it is, 

18 harvesting it, that you could use, if necessary, 

19 under emergency situations -- and again, I keep 

20 stressing that; this is not to be used 

21 prophylactically -- that you could have used the 

22 ivermectin at the moment or fenbendazole and 
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1 moxidectin.

2 There were questions raised by some 

3 commenters, very few, raising the concern that 

4 there may be residues in the wool of the animals. 

5 I've looked extensively at that, and I have asked 

6 anyone that suggests that to provide specificity 

7 as to any science on that. And I have not really 

8 found anything that is particularly substantive. 

9 There is some suggestion that there may be some with 

10 goat hair, but it was a study that didn't really 

11 provide us with enough information to get the 

12 necessary clarity as to what was being used and what 

13 was left in it. And it was, essentially, a 

14 non-detect.

15 We did hear this morning, when we asked 

16 a question, that for fenbendazole, for example, it 

17 can't be absorbed into wool. It goes into the 

18 parasite and that it is not in the tissue.

19 And further to address any of those 

20 concerns is that there is an extensive system for 

21 testing and for analyzing organic wool as it enters 

22 the market system, as it moves from one country to 
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1 another. And if it is going to be certified as 

2 organic, the standards require testing for 

3 pesticides, as, for example, for any kind of 

4 residues in the wool, and it is a pretty rigorous 

5 testing process. We haven't seen evidence of this 

6 as the fibers have moved through the international 

7 market.

8 I think that this is a pretty exciting 

9 proposal or a recommendation for us to be bringing 

10 forward here because, obviously, it is going to 

11 increase our market competition, if you will. 

12 But, also, at the same time, I think that it is going 

13 to be really good for the humane treatment of sheep, 

14 where sometimes, because of the need to get fleece 

15 to harvest, treating sheep may have been withheld. 

16 So, I think this is really great thing that we are 

17 going to be able to do here today.

18 Other questions on this?

19 Yes, Francis?

20 MEMBER THICKE: After I read this now, 

21 I am concerned about that word "production". We 

22 meant "harvest" when we were talking about it. 
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1 Should we and can we change that, because it is 

2 confusing? It sounds like it is kind of when you 

3 are going to start producing from the beginning of 

4 the growing of the hair.

5 MEMBER RICHARDSON: Can we do that as 

6 a simple change, Dr. Brines, or do we need a motion 

7 to amend the word from "production" to "harvest"? 

8 You want a motion?

9 DR. BRINES: So, the question is about 

10 amending the motion to change the term "production" 

11 to "harvest"?

12 MEMBER RICHARDSON: Yes.

13 DR. BRINES: If it's introduced as a 

14 friendly amendment, I guess the Chair could ask if 

15 there's any objection before moving forward with 

16 that vote.

17 CHAIR FAVRE: Okay. We have the issue 

18 of a friendly amendment. Do I have any objections 

19 to that from the Board?

20 (No response.)

21 Okay. So, what wording exactly do we 

22 want to put in there? Put in "harvest"?
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1 MEMBER RICHARDSON: The word 

2 "production" would be replaced by the word 

3 "harvest". And Francis and I were the makers of 

4 that motion, and we're happy with that.

5 CHAIR FAVRE: Okay.

6 MEMBER RICHARDSON: Yes, Dr. Brines?

7 DR. BRINES: Yes, just one 

8 clarification for the program as we move to 

9 implement this recommendation if it passed. The 

10 intent of the recommendation is that the production 

11 or harvest would be the point at which that 

12 fleece --

13 MEMBER RICHARDSON: Yes.

14 DR. BRINES: -- or wool is removed from 

15 the animal?

16 MEMBER RICHARDSON: Correct.

17 DR. BRINES: Thank you.

18 MEMBER BEHAR: I just want to make 

19 clear that, when we talk about fiber-bearing 

20 animals, we are not just only talking about sheep. 

21 Goats, there is alpaca, llama, and even Angora 

22 rabbits.
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1 MEMBER SWAFFAR: And buffalo.

2 (Laughter.)

3 MEMBER RICHARDSON: And camels maybe.

4 (Laughter.)

5 We have a camel down the street on the 

6 fiber farm near me. No.

7 Okay. We're ready for the question.

8 CHAIR FAVRE: Okay. The question has 

9 been called on the friendly amendment, and we will 

10 start the vote with Dan.

11 MEMBER SEITZ: Yes.

12 MEMBER RICHARDSON: Yes.

13 MEMBER BEHAR: Yes.

14 MEMBER SONNABEND: Yes.

15 MEMBER RICE: Yes.

16 MEMBER OAKLEY: Yes.

17 MEMBER THICKE: Yes.

18 MEMBER AUSTIN: Yes.

19 MEMBER BUIE: Yes.

20 MEMBER BECK: Yes.

21 MEMBER SWAFFAR: Yes.

22 MEMBER ROMERO-BRIONES: Yes.
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1 MEMBER DE LIMA: Yes.

2 VICE CHAIR CHAPMAN: Yes.

3 CHAIR FAVRE: The Chair votes yes.

4 MEMBER DE LIMA: It is 15 yes, zero no. 

5 The motion passes.

6 CHAIR FAVRE: Okay. We have got the 

7 motion as amended. It has come as a seconded 

8 amendment. So, we will now start the vote on the 

9 amendment as modified with Jean.

10 MEMBER RICHARDSON: Yes.

11 MEMBER BEHAR: Yes.

12 MEMBER SONNABEND: Yes.

13 MEMBER RICE: Yes.

14 MEMBER OAKLEY: Yes.

15 MEMBER THICKE: Yes.

16 MEMBER AUSTIN: Yes.

17 MEMBER BUIE: Yes.

18 MEMBER BECK: Yes.

19 MEMBER SWAFFAR: Yes.

20 MEMBER ROMERO-BRIONES: Yes.

21 MEMBER DE LIMA: Yes.

22 VICE CHAIR CHAPMAN: Yes.
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1 MEMBER SEITZ: Yes.

2 CHAIR FAVRE: The Chair votes yes.

3 MEMBER DE LIMA: Fifteen yes, zero no. 

4 The motion passes.

5 MEMBER RICHARDSON: The next motion 

6 for us to vote on is No. 3, "that the strikethrough 

7 language be removed and the underlined language be 

8 added at 205.603(a)(18)(i), fenbendazole. We are 

9 removing the written order of the licensed 

10 veterinarian, and instead, it goes on to say, "Milk 

11 or milk products from the treated animal cannot be 

12 labeled as provided for in Subpart (d) in this Part 

13 (4) two days following treatment of cattle, 36 days 

14 following treatment of goats, sheep, and other 

15 dairy species."

16 Again, this is a seconded motion from 

17 the Subcommittee.

18 The main thing we are doing here as, 

19 again, a bit of a technical -- well, primarily, it 

20 is to remove the fact this fenbendazole presently 

21 can be only used under the lawful written order of 

22 a licensed veterinarian.
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1 CHAIR FAVRE: Is there any discussion?

2 Go ahead, Dan.

3 MEMBER SEITZ: So, my question is, are 

4 you removing the veterinarian requirement because 

5 there is a stronger parasiticide that people might 

6 turn to, ivermectin, precisely because it would be 

7 more readily available to them? And so, you have 

8 an unintended consequence that you might move to 

9 something that is less satisfactory. Is that 

10 correct?

11 MEMBER RICHARDSON: Yes, that is a 

12 correct analysis. We are trying to get 

13 consistency, so that all of them can be the same 

14 and in order to have a more benign parasiticide 

15 rather than the ivermectin.

16 MEMBER SEITZ: And just a follow-up 

17 question. When you remove the veterinarian 

18 requirement, is there a possibility that you, among 

19 some farmers, you might see people starting to use 

20 it more routinely rather than in emergencies? Is 

21 that a drawback to that?

22 MEMBER RICHARDSON: The organic 
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1 production of livestock prohibits the routine use 

2 of parasiticides. And so, it will be up to the 

3 certifiers and the inspectors to ensure that that 

4 does not take place.

5 CHAIR FAVRE: Harriet, did you still 

6 have a question?

7 MEMBER BEHAR: I just want to make 

8 clear that another dairy species is water buffalo. 

9 People do make mozzarella cheese out of that.

10 MEMBER RICHARDSON: We did talk about 

11 that in Subcommittee.

12 CHAIR FAVRE: We actually did.

13 Any other discussion?

14 (No response.)

15 Okay. Seeing none, we will start the 

16 vote with Harriet.

17 MEMBER BEHAR: Yes.

18 MEMBER SONNABEND: Yes.

19 MEMBER RICE: Yes.

20 MEMBER OAKLEY: Yes.

21 MEMBER THICKE: Yes.

22 MEMBER AUSTIN: Yes.
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1 MEMBER BUIE: Yes.

2 MEMBER BECK: Yes.

3 MEMBER SWAFFAR: Yes.

4 MEMBER ROMERO-BRIONES: Yes.

5 MEMBER DE LIMA: Yes.

6 VICE CHAIR CHAPMAN: Yes.

7 MEMBER SEITZ: Yes.

8 MEMBER RICHARDSON: Yes.

9 CHAIR FAVRE: The Chair votes yes.

10 MEMBER DE LIMA: It's 15 yes, zero no. 

11 The motion passes.

12 MEMBER RICHARDSON: The fourth motion 

13 deals with ivermectin. And again, a reminder, it 

14 is our intention to remove ivermectin from the 

15 National List, hopefully, this fall.

16 So, this simply says, really it's -- I 

17 can't remember why we have to do this.

18 205.603(a)(18)(ii), ivermectin, and it 

19 says, "Milk or milk products from a treated animal 

20 cannot be labeled as provided for in Subpart (d) 

21 of this part for 90 days following treatment."

22 VICE CHAIR CHAPMAN: You had to do it 
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1 because we removed it --

2 MEMBER RICHARDSON: Right.

3 VICE CHAIR CHAPMAN: -- as a global 

4 requirement on all of them.

5 MEMBER RICHARDSON: Right.

6 VICE CHAIR CHAPMAN: Yes.

7 MEMBER RICHARDSON: Yes.

8 MEMBER SONNABEND: I don't really 

9 understand.

10 MEMBER RICHARDSON: Well, we had to 

11 split it up. They were grouped, remember? The 

12 way they were all listed originally, they were all 

13 grouped into sort of a block. So, we had to split 

14 them, each of the different ones out. They didn't, 

15 right.

16 So, this, again, clarifies the rule, so 

17 that we can look at each of them separately instead 

18 of all grouped together.

19 MEMBER DE LIMA: Harriet?

20 MEMBER BEHAR: Well, that will also 

21 make it easier to take ivermectin off.

22 MEMBER RICHARDSON: Yes.
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1 MEMBER DE LIMA: Any further 

2 discussion?

3 (No response.)

4 CHAIR FAVRE: Okay. We are ready for 

5 the vote. We will start that vote with Zea.

6 MEMBER SONNABEND: Yes.

7 MEMBER RICE: Yes.

8 MEMBER OAKLEY: Yes.

9 MEMBER THICKE: Yes.

10 MEMBER AUSTIN: Yes.

11 MEMBER BUIE: Yes.

12 MEMBER BECK: Yes.

13 MEMBER SWAFFAR: Yes.

14 MEMBER ROMERO-BRIONES: Yes.

15 MEMBER DE LIMA: Yes.

16 VICE CHAIR CHAPMAN: Yes.

17 MEMBER SEITZ: Yes.

18 MEMBER RICHARDSON: Yes.

19 MEMBER BEHAR: Yes.

20 CHAIR FAVRE: The Chair votes yes.

21 MEMBER DE LIMA: It's 15 yes, zero no. 

22 The motion passes.
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1 MEMBER RICHARDSON: The fifth and 

2 final motion is to, again, tidy up the way the 

3 language is written and to clarify an error. It 

4 is the way in which moxidectin was initially 

5 listed.

6 So, the fifth motion says, "That the 

7 strikethrough language be removed and that the 

8 underlined language be added at 

9 205.603(a)(18)(iii), moxidectin," and deleting 

10 "for control of internal parasites only". So, 

11 that way, it can be allowed for both internal and 

12 external.

13 And then, again, because we are 

14 breaking up the three parasiticides, we repeat 

15 "Milk or milk products from a treated animal cannot 

16 be labeled as provided for in Subpart (d) of this 

17 Part (iv) two days following treatment of cattle, 

18 36 days following treatment of goats, sheep, and 

19 other animals."

20 MEMBER SWAFFAR: Any discussion?

21 MEMBER SEITZ: Just a question. My 

22 impression from the conversation was that 
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1 moxidectin is more problematic a substance than 

2 fenbendazole. Is that correct?

3 MEMBER RICHARDSON: You know, I guess 

4 if you were to rank them, yes, probably so. 

5 Fenbendazole is the most benign. Moxidectin and, 

6 then, way down the list there would be ivermectin. 

7 Having two of them gives you a range. It means you 

8 are not going to be stuck with just one. Again, 

9 always only in an emergency situation.

10 And sometimes what you can do is, if you 

11 do have an emergency situation, as I think Dr. 

12 Henderson described this morning in his comments, 

13 and also we have read it, is that, if the animal 

14 is treated, again, in an emergency situation and 

15 the moxidectin doesn't appear to fix the problem 

16 immediately, the fenbendazole, then they could 

17 follow it up with the moxidectin if necessary.

18 So, it is like having an extra tool in 

19 the toolbox. It is not used as widely as some of 

20 the other materials.

21 MEMBER SWAFFAR: Tom?

22 VICE CHAIR CHAPMAN: Yes, and I think 
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1 there were also comments -- and other more expert 

2 people, please tell if I get this right or

3 wrong -- that having the two different 

4 parasiticides was important at not developing 

5 resistance to the parasiticides. So, in fact, the 

6 allowance of two would potentially lower chance of 

7 a resistance issue.

8 MEMBER SWAFFAR: Tracy?

9 CHAIR FAVRE: Yes, and I had done some 

10 reading, which I have discussed at the fall meeting 

11 last fall, that moxidectin, while it does have some 

12 impact, it does dissipate faster than the 

13 ivermectin. And so, it is less, in fact, impactful 

14 on, for instance, dung beetles. So, while it is 

15 in a similar family, it doesn't have the same 

16 impact.

17 MEMBER SWAFFAR: Francis?

18 MEMBER THICKE: Also, it may depend 

19 upon what the infection is. One parasiticide 

20 might have more efficacy on one species and another 

21 one on another species. So, that gives more of a 

22 range.
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1 MEMBER SWAFFAR: Any further 

2 discussion?

3 (No response.)

4 CHAIR FAVRE: Okay. We are ready for 

5 the vote, and we will start with Scott on this one.

6 MEMBER RICE: Yes.

7 MEMBER OAKLEY: Yes.

8 MEMBER THICKE: Yes.

9 MEMBER AUSTIN: Yes.

10 MEMBER BUIE: Yes.

11 MEMBER BECK: Yes.

12 MEMBER SWAFFAR: Yes.

13 MEMBER ROMERO-BRIONES: Yes.

14 MEMBER DE LIMA: Yes.

15 VICE CHAIR CHAPMAN: Yes.

16 MEMBER SEITZ: Yes.

17 MEMBER RICHARDSON: Yes.

18 MEMBER BEHAR: Yes.

19 MEMBER SONNABEND: Yes.

20 CHAIR FAVRE: The Chair votes yes.

21 MEMBER DE LIMA: Fifteen yes, zero no. 

22 The motion passes.
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1 MEMBER SWAFFAR: So, that concludes 

2 the livestock portion, and I would like to thank 

3 Jean and Francis for their leadership on both the 

4 lidocaine, procaine, and parasiticides. That was 

5 a lot of work and I really appreciate their work 

6 on that.

7 CHAIR FAVRE: Okay. We're going to 

8 move on into the Policy Development Subcommittee 

9 work.

10 Tom?

11 VICE CHAIR CHAPMAN: Thank you.

12 We have two proposals for us from the 

13 Policy, one proposal and one discussion document, 

14 two items from the PDS.

15 We will first start with the PPM. If 

16 we could go to the PowerPoint?

17 And then, where would I find the 

18 clicker? Thank you.

19 While we wait for the PowerPoint to go 

20 up, I was curious to know if the Chair had any jokes 

21 to tell.

22 (Laughter.)
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1 CHAIR FAVRE: Sorry, I didn't hear the 

2 joke. I'm sorry.

3 (Laughter.)

4 I was going to say, actually, I think 

5 you should, but go ahead.

6 VICE CHAIR CHAPMAN: Yes.

7 CHAIR FAVRE: You could clean it up for 

8 the public. All right.

9 VICE CHAIR CHAPMAN: Does Member 

10 Richardson have a joke?

11 CHAIR FAVRE: Talk to Jean later. 

12 She's got a great joke about dung beetles.

13 VICE CHAIR CHAPMAN: All right. There 

14 we go.

15 All right. So, I am going to take this 

16 opportunity to walk through the proposed changes 

17 to the Policy and Procedures Manual, explain the 

18 background, work our way through public comment, 

19 and then, talk a little bit more about the changes.

20 So, a little bit of background. Why is 

21 there a revision to the PPM before us now? The 

22 current version that we have before us, the 2012 
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1 version, is woefully out-of-date, I would say 

2 almost to the point of irrelevance. It hasn't been 

3 updated in four years and it doesn't match the 

4 procedures used by the Board today.

5 As a point of history, since 2002 to 

6 2012, on average, the document was revised every 

7 nine months. So, every four meetings, three of 

8 those meetings would have had a revision to that 

9 Manual. And in the last four years, it has been 

10 stagnant, not touched at all.

11 So, it doesn't current reflect our 

12 operating practices. There are sections of it 

13 that do not comply with FACA, and FACA is a 

14 requirement of OFPA. So, it conflicts with both 

15 FACA and OFPA in that sense. And it is fairly 

16 confusing, and we have to remember that there is 

17 a lot of turnover.

18 We are all lucky that at this set of 

19 meetings we're all doing positive motions. But, 

20 as we get to the fall, we will also have negative 

21 motions mixed in with positive motions. And 

22 having a clear procedure on that, it is helpful. 
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1 I know that from my experience last year. You guys 

2 will experience in the fall the new members. And 

3 then, starting in 2017, we will also have another 

4 five new members. And then, ultimately, we also 

5 wanted to keep everything that has been done before 

6 that we can and move that forward to the future.

7 There's been a lot of questions about 

8 where and how this initiated. It initiated by the 

9 Chair, Chair Richardson, in 2014. And this is an 

10 email. This is everything I share here is either 

11 public record via FOIA or on our meeting notes 

12 section of the NOSB web page.

13 So, here the Chair asked the Deputy 

14 Administrator via the Executive Committee to add 

15 the Policies and Procedures Manual to the work 

16 agenda, and the NOP agreed to add it to the work 

17 agenda to allow the NOSB to lead the process and 

18 to collaborate with us.

19 So, what was the starting place for 

20 this? The starting place was previous work done 

21 on the PPM prior by previous Boards. And we 

22 started with that working document and expanded on 
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1 it.

2 What was the NOP's involvement in it? 

3 Very supportive in nature, a lot of administrative 

4 assistance. This is a very large document. It 

5 required a lot of edits to it. So, oftentimes, we 

6 would discuss the wording we wanted, advise the NOP 

7 staff to make those changes, and submit them to us. 

8 They would make those changes and send it back to 

9 us, incorporating any changes from several 

10 different members and several different 

11 iterations.

12 And then, we would discuss how they 

13 wrote it up, and if it wasn't to our liking, then 

14 we would send it back again, and again, and again.

15 (Laughter.)

16 So, what was our, the NOSB's 

17 involvement? Well, we proposed the changes. We 

18 discussed them. We approved them. And we 

19 considered, since this came up in the fall for 

20 public comment, we received public comment on this 

21 document. We, then, took that back, discussed it, 

22 proposed further changes, and approved those as 
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1 well.

2 This is all documented in our 

3 Subcommittee notes, and you will see there is a lot 

4 of discussion of member-proposed changes, 

5 discussions, changes, approvals, all the way from 

6 mid-2015, this one item month after month.

7 (Laughter.)

8 All right. So, it gets to the crux of 

9 the argument. This has been sent around quite a 

10 bit or questioned in public comment quite a bit. 

11 Who has authority over the Policies and Procedures 

12 Manual? And as you read the rules, we are governed 

13 by OFPA. That is why they established the National 

14 Organics Standards Board, and in that line 

15 establishing the National Organics Standard, it 

16 states "in accordance with FACA". So, OFPA and 

17 FACA, while two different laws, are actually one 

18 and the same for us because they are both there, 

19 requirements.

20 In FACA, there are statements in there 

21 about how advisory committees are managed. "The 

22 CMO is to exercise supervision over the 
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1 establishment and procedures and accomplishments 

2 of the advisory committees." Procedures is pretty 

3 clearly laid out there in FACA and the authority 

4 with the CMO.

5 That being said, the way the NOSB has 

6 acted over the last multiple years, decades, 

7 multiple decades, decades anyway, is, by 

8 tradition, the NOSB has had complete and sole 

9 authority for the most part over the PPM until 

10 recently.

11 I would say that everyone is developing 

12 and improving with time. Some of us are better 

13 with procedures than others. We haven't always 

14 complied with all the rules above, with OFPA and 

15 FACA, as well as it should have been. And I think 

16 there is a greater awareness of all the 

17 requirements under FACA than there has been before.

18 That being said, to the PPM reduce the 

19 NOSB's authority and independence? To that, I 

20 would say it brings the PPM into compliance with 

21 FACA and, therefore, OFPA, which is critical.

22 And the PPM, it is important to 
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1 remember, is only authoritative on the NOSB, the 

2 15 members here that vote. So, no matter what we 

3 put in there, it doesn't make it binding on other 

4 parties. It doesn't make it binding on the NOP. 

5 It doesn't make it a law. It doesn't change OFPA. 

6 It doesn't change FACA.

7 But one of the important things about 

8 all these revisions here is that it does remain the 

9 NOSB's authority to approve the PPM, and it sets 

10 a very collaborative nature with the NOP and 

11 acknowledges our mutual roles and respect for each 

12 other and the positive intent that we have working 

13 in the organic community.

14 So, clearly, from the public comments 

15 and everything we heard today, you can tell that 

16 there is a lot of ambivalent perspectives on this 

17 document. There is a tension between tradition 

18 and compliance with OFPA and FACA. There is some 

19 tension between keeping historical and current 

20 wording to matching our current operations. The 

21 document is in some degrees aspirational versus 

22 accurate, and there is a tension there. There has 
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1 been a perceived tension between independence and 

2 collaboration.

3 As everything is in the organic 

4 community, it is very complex. So, there is a 

5 request for the NOSB to act in protest versus 

6 compromise in regards to certain actions that we 

7 may or may not agree with.

8 But the objective of this PPM revision 

9 was to make a PPM that complies with OFPA, complies 

10 with FACA, is approved by us as well as the agency 

11 that we advise and the Secretary. It accurately 

12 reflects our current operating procedures. It 

13 fosters transparency and public participation. 

14 It reflects and builds upon the past versions of 

15 the PPM. It has a logical structure with correct 

16 grammar, which I don't know why I was put in charge 

17 of this Subcommittee because I have the worst 

18 grammar of anyone I know.

19 And it fosters a continuous 

20 improvement. This version is not the last version 

21 of the PPM. I anticipate it going along the lines 

22 of how it had from 2002 to 2012, as a document that 
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1 is continuously improved upon.

2 So, getting into the public comments, 

3 the cites are kind of color-coded a little bit. I 

4 have quotes from the public input on major subject 

5 areas. I kind of will discuss a couple of the 

6 teasing-out of what was said.

7 Then, if you see a red slide, it is 

8 usually either from FACA or OFPA or it is guidance 

9 from the General Services Administration, GSA.

10 Did I get that right? Yes.

11 And if it is blue, then it is what is 

12 in our proposal.

13 We received something like 800 

14 individual comments, several comments from public 

15 interest groups, several comments written, and 

16 then, one comment from a distribution company.

17 So, the first theme I want to address 

18 in public comments was the NOSB and the PDS's 

19 authority and ability to approve and revise the 

20 Policy and Procedures Manual. I received several 

21 comments from the public in this area.

22 The proposed rule adds a new section, 
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1 Section 9, although there was some similar verbiage 

2 to this in the intro. But in Section 9, it states, 

3 "Proposed changes will be subject to review and 

4 approval by the NOP and the full NOSB." So, it 

5 acknowledges that both our Board as well as the NOP 

6 need to agree to this document.

7 Under OFPA and FACA, again, FACA is 

8 required in OFPA. You will hear me say that line 

9 a lot.

10 The CMO has the ability to exercise, has 

11 the requirement to exercise control and 

12 supervision over the procedures of its advisory 

13 committees. That is why we put this section in 

14 here. It makes sense to have the NOP in there as 

15 well as us.

16 In the NOSB/NOP collaborative area, we 

17 received substantial comment from the public 

18 saying that it had become less collaborative. The 

19 comments here were extensive and wordy. But, to 

20 boil it down -- and I probably will miss a few 

21 points -- there was a lot of discussion of 

22 bureaucratic constraints, such as financing, 
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1 costs, to pay for or to prioritize actions taken 

2 by or approved by the NOSB, about actions on our 

3 advice or recommendations given to the program, 

4 about whether or not we are consulted on various 

5 areas of the program.

6 There was a little bit, back again, 

7 about our ability to change our own procedures and 

8 whether or not we could bind the program to 

9 contract, fund things, make staffing decisions.

10 So, what the Policy and Procedures 

11 Manual does in this section makes it clear and cites 

12 all the regulatory or all the operating legislation 

13 above us, the OFPA and FACA sections of the rule. 

14 Throughout the document you will see a theme of us 

15 reasserting OFPA and FACA and our compliance with 

16 that, as well as the Government in the Sunshine Act.

17 And it does have the statement that we 

18 cannot bind or obligate funds, contract, or make 

19 NOP staffing decisions. Now I will talk about the 

20 Staff Director a little bit later. So, I am going 

21 to set that one aside, the Staff Director in 

22 particular, but I will talk about NOP staffing 
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1 here.

2 And then, to obligate funds, it is 

3 important to note that OFPA itself does not, did 

4 not come with any appropriations. There is a lot 

5 of historical debate around this item, and the 

6 Senate bill had appropriations in it; the House 

7 bill did not. In the Senate Conference Committee, 

8 the House version was accepted and appropriations 

9 were pulled out of the bill. There are no 

10 appropriations given to the NOSB.

11 So, I have a hard time finding how we 

12 can obligate funds that we do not have. We have 

13 a bank account of zero, an account for zero dollars.

14 Down at the bottom, I also wanted to 

15 emphasize this point. We added the line, 

16 "Similarly, the NOP, as required through OFPA, must 

17 consult and collaborate with the NOSB." We have 

18 accentuated throughout this document that our role 

19 is to advise the Secretary, and that they must 

20 consult with us and collaborate with us on all these 

21 items.

22 And we a whole bunch of -- I mean, again, 
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1 it is on that same theme of collaboration and 

2 working together. It just extenuates our role and 

3 the NOP's role. The same Act created both us and 

4 the NOP, and we both function best when we function 

5 together.

6 So, the rules that support this, as OFPA 

7 states, you know, that the Secretary shall consult 

8 with the NOSB. Our role is to assist and to advise, 

9 as well as our statutory authority over the 

10 National List.

11 But, when it talks about staff -- and 

12 this why I wanted to pull out this one cite -- so, 

13 the ability of us to dedicate staff, OFPA actually 

14 states specifically that that is an authority of 

15 the Secretary. So, the Secretary shall detail 

16 staff of the Department of Agriculture or allow for 

17 the hiring of staff, but that is the decision of 

18 the Secretary, subject to the necessary 

19 appropriations, and pay necessary expenses 

20 incurred by such Board in carrying out the 

21 provisions of this Chapter, as determined 

22 appropriate by the Secretary.
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1 So, the Secretary has authority to 

2 issue funds. The Secretary has the authority to 

3 pay for the items if it deemed necessary by the 

4 Secretary and the funds are available.

5 Furthermore, FACA describes again 

6 controls over the policies and procedures of it. 

7 I don't need to go into it because I have read it 

8 in previous sections already.

9 So, work agendas was another item that 

10 came up substantially. Public comment was quite 

11 clear that they wanted NOSB sole authority over the 

12 work agendas and work plans, as they were formally 

13 called.

14 And again, in this section, OFPA 

15 requires compliance with FACA, and FACA is 

16 explicitly clear that the Designated Federal 

17 Officer shall approve the agenda.

18 On the work agenda proposal, however, 

19 it offers a very collaborative and middle road 

20 comparative to where we used to be versus what FACA 

21 states can be done, which is that it gives several 

22 routes for agenda and work agenda items to come 
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1 forward before the Board. And that is from the NOP 

2 as well as from the NOSB, as well as from public 

3 comment.

4 And then, it puts some scope, it puts 

5 some requirements on those. And one of those is 

6 to put clarity on how and where these things are 

7 coming from. So, one of those is scope, which I 

8 want to emphasize here that this actually is a very 

9 good change, which I think a lot of people overlook.

10 In addition, the public may submit 

11 comments to the NOSB and write to the NOP for 

12 potential additions to the work agenda for the 

13 NOSB. The work agenda items may emerge from 

14 discussions on current issues.

15 The section on this work agenda item 

16 focuses on and emphasizes the fact that these will 

17 come from the Board and from the public. It also 

18 talks about the priority of these items, and it is 

19 something that the NOP can implement within a 

20 reasonable timeframe as well as speaking for clear 

21 need. And again, this is a section that oftentimes 

22 was not liked by the community, but, actually, 
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1 meets a lot of our needs. In the sunset, it says, 

2 "Clear need from the NOP or community for which new 

3 or additional information or advise is needed." 

4 So, it is looking for a clear need from the organic 

5 community, not just the NOP.

6 So, then, as it goes on, it also details 

7 the process by which this is approved and added, 

8 and it prioritizes the way proposals are done. 

9 But, again, as we do throughout this document, we 

10 emphasize the NOSB process and the NOSB's role in 

11 providing work agenda items.

12 And then, we go on to detail various 

13 types of possible work agenda items, including 

14 materials, changes to annotations, modifications 

15 to standards or new standards, advice on NOP 

16 policies, compliance and enforcement activities, 

17 as well as management and review of the NOP.

18 Another section that received a lot of 

19 public comment was conflict of interest, 

20 particularly around a topic of interest for Board 

21 members. In fact, OFPA requires compliance with 

22 FACA. In FACA, it directs the GSA Administrator 
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1 to prescribe administrative guidelines for these 

2 types of issues, as well as provide us advice to 

3 be able to implement our roles and duties as an 

4 Advisory Committee.

5 The GSA offers specific guidance on 

6 ethics and conflict of interest. We are 

7 classified as representatives. And as 

8 representatives, it pretty much puts no obligation 

9 on us in terms of conflict of interest. However, 

10 it has a statement that, if we choose to 

11 globally -- if it is implemented globally across 

12 the standard, then the standard for special 

13 governmental employees can be applied to 

14 representatives.

15 And that is what has happened in our 

16 case. The requirements for conflict of interest 

17 is the conflict-of-interest requirements for 

18 special government employees, and it details them 

19 in specific detail, about direct disproportional 

20 conflict benefits to individuals, conflicts that 

21 could impair judgment or objectivity, and the 

22 potential for an unfair competitive advantage.
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1 It notes that we are appointed to 

2 represent our interests. And then, it lays out the 

3 method by which we do our conflict-of-interest 

4 disclosures in great detail. That is done by, 

5 instead of ad hoc here at the meeting, it is done 

6 prior to the meeting, two to four weeks in advance. 

7 It is circulated amongst the entire Board, and 

8 everyone discloses the conflicts of interest on the 

9 voting items before. And then, that is 

10 accumulated and sent out to the entire Board and 

11 becomes part of the public record, if it is part 

12 of the Board. Any conflicts of interest that there 

13 are will be disclosed at the time of voting.

14 So, just to emphasize that, under the 

15 requirements of the GSA, there are virtually no 

16 conflicts of interest, and instead of going with 

17 no, we opted up a level to the special government 

18 employees, which provides substantial guidance on 

19 conflict of interest.

20 The Advisory Committee Specialist and 

21 Staff Director, there were several comments about 

22 this and in two different regards, one about the 
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1 NOSB's authority to hire a Staff Director and one 

2 in the theme of changing some of the requirements 

3 that we have for the Advisory Committee Specialist, 

4 formerly called the Executive Director.

5 And in this regard, OFPA does clearly 

6 state that the Secretary shall authorize the Board 

7 to hire a Staff Director. That is unequivocal. 

8 That is quite clearly stated in OFPA. I do not 

9 disagree with that.

10 To give some history on the Staff 

11 Director, I combed through history from the NOSB 

12 minutes from 1992 to today, and there was some 

13 interesting history in there. So, in May 1993, Hal 

14 Ricker, who was the first USDA person in charge of 

15 things -- that's his official job 

16 description -- was referred to in the May 1993 

17 minutes as a Staff Director. It is important to 

18 note that he was not hired by the NOSB.

19 In April 1995, they stopped referring 

20 to him as the Staff Director and started referring 

21 to him as a Program Leader. Then, in 1996, he 

22 became Program Manager, which several people are 
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1 probably familiar with that title. That one stuck 

2 around for a while.

3 In 2002, calls from the public started 

4 to be made in regards to that section of OFPA that 

5 required or that allowed the NOSB to hire a Staff 

6 Director. In 2004, appropriations were made in 

7 the NOSB FACA budget, enlarged for the hiring of 

8 a Staff Director.

9 And in the October 2014 minutes, 

10 Barbara Robinson, who was the AMS Deputy 

11 Administrator for Transportation, Transportation 

12 Marketing, came and talked before the NOSB Board 

13 about the hiring of a Staff Director. If you look 

14 at those minutes, what you will see, what she states 

15 to the Board, that it must be a federal employee 

16 supervised by a federal employee. They cannot 

17 directly at the direction of the Board, but they 

18 wanted this role to fulfill the Staff Director role 

19 as much as possible. And so, they would highly 

20 collaborate with the NOSB on this role.

21 They took a job description which was 

22 standard AMS job description for Board Specialist, 
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1 along with the Draft Job Description from the USDA 

2 for the Staff Director, and combined them together. 

3 This is also where the name Staff Director got 

4 changed into Executive Director. They 

5 specifically asked the NOSB, "Do you want to call 

6 the Staff Director or do you want to call it the 

7 Executive Director?" And they clearly said, "We 

8 want it to be called the Executive Director."

9 In all things government, that was 

10 October 2004. In August of 2005, one year later, 

11 a Job Description was finalized and finally posted. 

12 And then, six months later, someone was finally 

13 hired. So, two-and-a-half years later, Valerie 

14 Frances was announced as the Executive Director, 

15 and at the same time Katherine Benham was hired as 

16 the Advisory Board Specialist. It was a role 

17 supportive of the Executive Director.

18 In October of 2010, Lisa took over that 

19 role and replaced Valerie. In 2011, Katherine 

20 Benham transferred out of the AMS, and that 

21 position was not refilled. And around the same 

22 time, Lisa A. transitioned roles within the NOP.
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1 In November of 2011, Lorraine Coke 

2 filled that role of Board Specialist and the 

3 Executive Director temporarily. And in May 2012, 

4 Michelle was -- I mean, she might have been hired 

5 before; these dates are based on minutes -- in May 

6 2012, Michelle was announced as the Advisory Board 

7 Specialist, and that was a new USDA job title for 

8 that Executive Director Job Description.

9 In April 2013, calls from the public 

10 started again for a Staff Director. At this point, 

11 it was asserted that that Staff Director was 

12 actually what is now the Deputy Administrator's 

13 job, not the job that Michelle now holds.

14 So, that is kind of the history through 

15 the minutes. It is quite clear that this is a 

16 somewhat-sloppy section of the areas.

17 There has been a lot of call for us to 

18 assert in the Policy and Procedures Manual that we 

19 have a Staff Director and that we hire the Staff 

20 Director. But, again, at this time, we have no 

21 funds to do it. Us putting it in here and getting 

22 it approved does not make it so. And I wanted it 
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1 to reflect reality.

2 The moment we have the funds to hire our 

3 own Staff Director, if we wanted to, the PDS would 

4 take up without issue and a Job Description in no 

5 time. That being said, it is quite clear that the 

6 Advisory Committee Specialist role that we have now 

7 was designed to fulfill that role, whether or not 

8 it was hired by us.

9 Moving on from the Staff Director, 

10 there was a comment about us removing the line -- it 

11 is the most important job of the Executive Director 

12 is to defend the independence of the Board. We did 

13 take that line out. We just got through talking 

14 about a bunch of conflicts of interest. I cannot 

15 think of a greater conflict of interest than to have 

16 someone hired by the NOP defend the authority of 

17 another organization as part of their job. I mean, 

18 you are asking them to, basically, go against their 

19 own boss. They have a financial interest there by 

20 its being their job.

21 What we did do was add the words "ensure 

22 all FACA and OFPA requirements are implemented," 
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1 and that details clearly all the requirements of 

2 the NOSB and its role here. And so, we feel like 

3 that clearly covers that section.

4 I also want to note that it is of 

5 importance to everyone, the community -- clearly, 

6 you guys take that as very important because we 

7 heard in public comment -- as well as the Board 

8 itself to defend its own independence. We can't 

9 rely on an Advisory Committee Specialist to do that 

10 for us. That is a role that is placed on us in this 

11 regard.

12 Access to public information was 

13 another common theme. Although we did get some 

14 slight praise in this area, there is still a lot 

15 of criticism around FACA implementations of public

16 information access and disclosure and 

17 transparency. And there were accusations that our 

18 PPM restricted access to publication beyond FACA's 

19 requirements.

20 So, to review the sections of FACA 

21 related to public disclosure, it clearly states the 

22 documents, which pretty much is everything that 
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1 comes before the Board, are available to be 

2 FACA'ed. And we put that word for word into our 

3 PPM.

4 It also states, though, that "shall be 

5 available" -- it gives a location for those 

6 documents, and "shall be available for public 

7 inspection, copying, at a single location in the 

8 Office of the Advisory Committee or the agency to 

9 which the Advisory Committee reports until it no 

10 longer exists." So, it also has clear guidance on 

11 where to get that information via FACA.

12 Beyond that, it also clearly lays out 

13 that the person in charge of making sure that 

14 information is available and maintained is the 

15 Advisory Committee Management Officer, not the 

16 Board itself.

17 And then, further in the GSA guidance, 

18 it specifically states that representative members 

19 are reminded that non-public information should 

20 not be released to the public without permission. 

21 Part of that is so that it goes through the entire 

22 FACA and FOIA review to make sure that only 
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1 appropriate information is released.

2 So, what does our PPM say in this 

3 section? Well, first of all, I want to note that 

4 in the recordkeeping section we made it clear that 

5 we want transcripts of our full Board meetings, 

6 which is not a FACA requirement, but every word I 

7 say, every "uh" will be in the record, a lot of 

8 "Uh's".

9 (Laughter.)

10 Some transcriptionists actually drop 

11 the "Uh's". So, I appreciate that. Let's do that 

12 this time.

13 (Laughter.)

14 So that we have greater transparency 

15 into what occurred in those meetings, so that 

16 people like me can comb through the records all the 

17 way back to 1992.

18 We also copy word for word the FACA 

19 requirements, like I said, for accessibility of 

20 those documents. We also copy into the sections 

21 about FOIA and make explicit that the only thing 

22 preventing release of information is the FOIA 
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1 exemptions. That's the FOIA information.

2 In addition to this, under the 

3 additional standards of conduct section, we put in 

4 two lines about Board members and the release of 

5 information. This is to comply with that section 

6 of the GSA guidance that members shouldn't do it. 

7 It is also to make sure that, when information is 

8 released to the public, it is done via the FACA and 

9 FOIA process appropriately, as prescribed in FACA 

10 or FOIA, as applicable.

11 That is not a role that is done by Board 

12 members. It is a role that is done explicitly as 

13 described in FACA. I will move from there.

14 Sunset voting procedures. This is 

15 probably the one that most people are concerned 

16 about here.

17 So, there was a lot of comment received 

18 that we shouldn't make any changes to the sunset 

19 sections while a lawsuit is pending against the 

20 program. And there was a lot of comments saying 

21 that this is an acceptance of the Board of the 

22 changes made in 2013.
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1 What does our proposal actually say? 

2 Well, we start off by citing OFPA and what OFPA says 

3 about sunset. We thought that that was very 

4 important to start anywhere where the authority was 

5 first written and given by Congress.

6 We follow that by citing the memo from 

7 the National Organic Program that we are currently 

8 operating under from September 16, 2013. At the 

9 end of that section, a sentence is in there that 

10 is very important that says, "The NOSB observes the 

11 following procedure:" I want to emphasize this 

12 one. The sentence wasn't put in there by accident 

13 and wasn't put in there sloppily. It was 

14 specifically put in there. "The NOSB observes the 

15 following procedure:"

16 Look up the definition of "observes," 

17 and it is to comply with an obligation. I want to 

18 say that that is the intent of this. It is not to 

19 accept, to approve, to support, to endorse. It is 

20 none of those words related the 2013 memo from the 

21 program. It is just to comply with an obligation.

22 Several materials have come before the 
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1 Board for voting related to sunset. I think this 

2 is now in the fourth cycle since the 2013 memo, and 

3 the Board has adopted a procedure because the Board 

4 wanted items to have a vote. To do that, we have 

5 these motions to remove, and that results in 

6 motions to remove that are kind of sloppy, that are 

7 a little weird, a little hard to understand, 

8 especially when they are intermixed with motions 

9 to approve or list.

10 And having clear procedures that Board 

11 members understand and can vote on is very 

12 important. It is about outlining those 

13 procedures. It is not about accepting, approving, 

14 supporting these changes.

15 You can have objections to the changes 

16 and still support the procedures we're operating 

17 under now. And those procedures are outlined 

18 here.

19 It also, at the same time, is talking 

20 about the motion to remove, which is right here. 

21 "When presented to the full NOSB, the reviews will 

22 contain a motion and a second from the 
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1 Subcommittee, and the motions for removal will be 

2 based on preliminary review." It goes on with 

3 that, but it puts the motion to remove in there and 

4 requires a vote on all sunset materials.

5 It also has the public comment review, 

6 which I think after we have gotten it under our 

7 belt, it actually isn't seen as a great positive 

8 move in this regard.

9 Minority view and opinion. There was 

10 a change to the minority opinion. We moved it to 

11 minority view, in line with what is in Robert's 

12 Rules. Robert's Rules actually calls it a 

13 minority report, but that was an awful movie with 

14 Tom Cruise.

15 (Laughter.)

16 So, we decided to go with the word 

17 "minority view".

18 A lot of this section here was to 

19 clarify and to bring closer-in the dissenting 

20 opinions. What that means is to say is, when we 

21 put forward a proposal, we want that proposal to 

22 represent all views when possible. Clearly, we 
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1 are a passionate bunch of folks, and there are times 

2 when we are so passionate that we can't put all of 

3 our ideas in the same proposal, even if we are 

4 voting on it. But, oftentimes, we have been able 

5 to do that. Oftentimes, you will see in the most 

6 recent reviews a discussion of all opinions on the 

7 items as well as the vote, and why people voted 

8 different ways. It can be done. It is currently 

9 being done by our Board. And it is just clearly 

10 outlining the method of doing this and 

11 incorporating it into our documents.

12 There is an often-quoted section of a 

13 quote from Kathleen Merrigan. And I went back to 

14 that Senate Committee meeting and took the full 

15 paragraph here. And I just wanted to emphasize the 

16 entire context of the line that is often quoted 

17 because the quote that we get was just talking about 

18 the NOSB's role as a gatekeeper, which she did say 

19 clearly here in relation to substances.

20 But she also noted that the whole point 

21 of the NOSB was to create a valid consensus amongst 

22 diverse stakeholders. And we think the minority 
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1 view emphasizes the consensus section. It doesn't 

2 mean we all have the same opinion. It means we 

3 can all put it in the same document, get along, have 

4 a discussion of varying viewpoints, and then, come 

5 to a vote on it.

6 Moving on -- and it will be quicker here 

7 because we are starting to run out of FACA areas, 

8 and it is more policy areas -- but conflict of 

9 interest for technical reviews, this one was a fun 

10 one. So, in this area we have had a lot of calls 

11 to have the Board review the individual people who 

12 do the technical reviews.

13 In the Policies and Procedures Manual, 

14 we clearly outline requirements for conflicts of 

15 interest. This is not at all existing in the 

16 previous version in the PPM. This is an addition 

17 to it. And I do question how much of the public 

18 access the Federal Acquisition Records because 

19 that link right there doesn't work, and we got no 

20 comments telling us that that link right there 

21 doesn't work.

22 But, if you go through and you find FAR 
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1 Subpart 3.1101, this is what it says, and it is 

2 quite extensive and detailed in regards to 

3 conflicts of interest of contracting parties as 

4 well as their employees. It speaks to the 

5 definition of personal conflicts of interest. 

6 Then, it goes on to define them as financial 

7 interests of the employees, close family members, 

8 or other members in the employee's household, other 

9 employment or financial relationships that that 

10 employee has or gifts, including travel, that they 

11 receive.

12 Beyond that, it begins to give examples 

13 such as compensation for business referrals, 

14 consulting relationships, services provided in 

15 exchange such as honorariums or travel, research 

16 funding, investments, real estate investments, 

17 patents, copyrights, other intellectual property, 

18 and business ownerships. It is extensive, the 

19 requirements under FAR.

20 Moving on -- see, now I am combining two 

21 slides into one; I'm speeding it up for you 

22 there -- electronic participation, we received 
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1 comments on this stating that the conditions under 

2 which electronic participation needed to be made 

3 clear. The sentence that we added to the PPM says, 

4 "In cases of medical situations preventing 

5 attendance of a person, a virtual person is 

6 permitted."

7 In the Subcommittee's opinion, in cases 

8 of medical situation preventing attendance of a 

9 person was fairly clear. The situation of 

10 electronic participation was clear. And so, we 

11 did not make any changes to this section.

12 Public comment asked that the NOSB 

13 authority over the National List was not clearly 

14 stated in the introduction particularly. I'm sure 

15 the introduction does say that we just propose 

16 amendments to the National Lists. But, then, if 

17 you go down to Section 1.C, then it says we also 

18 review petition materials for inclusion in or 

19 removal from the National List.

20 And then, if you go to III.E, it speaks 

21 of our statutory authority related to the 

22 recommendation of materials as approved in the 
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1 prohibited substances for inclusion on the 

2 National List. And if that wasn't enough, we have 

3 it yet again under III.F.

4 Nothing in the PPM is precluding our 

5 ability or our authority over the National List as 

6 prescribed in OFPA.

7 There is also public comment saying 

8 that it was unclear if Robert's Rules was used. 

9 So, we do have a section on parliamentary 

10 procedure. It is actually unclear because we 

11 stuck with the history of the PPM on here, of which 

12 Robert's Rules was adopted in 1992. And then, it 

13 was bona fide as being non-mandatory in 1993, just 

14 a year later. So, we kept that through there, and 

15 we noted all the items that we operate under.

16 There has been public comment about our 

17 changing the section on voting, which does not 

18 mandate a type of voting on roll call voting. And 

19 the new proposal says, "Voting may be by a show of 

20 hands, roll call, or by use of modern voting 

21 devices." We hope that one day we have those cool, 

22 little buttons that we can just push, and it has 
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1 our name and a light that shows it all for 

2 everybody.

3 I would like to note that, as I was 

4 combing through all these meeting minutes, even if 

5 a roll call vote had been done in the past, it wasn't 

6 always recorded in such a way to make it clear or 

7 any more clear than a hand vote, show of hands, yes.

8 And here's an example from the minutes 

9 in which Barry Flamm called for a vote. I do know 

10 on this item that Member Richardson voted no, and 

11 then, I have 13 votes that I don't quite know, 

12 except for the one that says, "No, sir." I have 

13 a good guess who that one was. And then, I know 

14 how the Chair voted on it. So, the voting record 

15 just gives the roll call votes. It wasn't always 

16 a clear record, either.

17 But I do want to note that we maintain 

18 a voting record. It is often handed out as a favor 

19 to members of the public. There are several 

20 members of the NOSB that keeps this. This one for 

21 our most recent meeting is under the AMS FOIA 

22 Reading Room for anyone to access.
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1 And even if we are having a show of 

2 hands, under Robert's Rules, any member can request 

3 a roll call vote at anytime. And that occurred 

4 several times during that meeting. Anytime a roll 

5 call vote was called for, it had occurred.

6 We maintained this section because 

7 there are times when our agenda is long and there 

8 are a lot of items to vote. And as you have seen 

9 on the items we have already voted on, there is a 

10 lot of consensus in this community on a lot of 

11 items. And it takes a lot of time to go through 

12 roll call votes. So, in respect for the 

13 volunteers' time, when it makes sense to do shows 

14 of hands because we may have a lot of matters 

15 pressing before the Board, we will move to that 

16 section. But it is not to obfuscate or make 

17 unclear who votes on what.

18 So, I just wanted to highlight some 

19 other important changes that didn't get as much 

20 attention in the public comments. Some people did 

21 comment on some of these items. Some of these just 

22 got missed.
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1 But we now allow for webinars for public 

2 comment to expand how we take in comment from the 

3 public and to widen how we can interact with the 

4 community, even those who cannot access us here or 

5 wherever we travel to for our meetings.

6 A really great section on the 

7 prohibition of withdrawals of petitions already 

8 reviewed by the Subcommittee. This is a very 

9 frustrating rule we don't operate under now. But, 

10 up until it goes to a vote, the petitioner can 

11 withdraw an item, even if the vote is not going the 

12 way they think they want it to go. And so, all the 

13 work done by the NOSB then goes kind of for naught. 

14 This, once it gets voted by the Subcommittee, it 

15 can no longer be withdrawn by the petitioner.

16 This establishes conflicts of interest 

17 for technical reviews, which were not in the 

18 previous version of the PPM. It describes the 

19 roles of the Subcommittee. It establishes GMOs as 

20 a purpose of the Materials Committee. It 

21 establishes research priorities as a purpose of the 

22 Materials Committee. And it is a logical, 
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1 flowing, grammatically-correct document.

2 We also received lots of public 

3 comments on areas that we didn't touch that would 

4 be great topics for us to pick up and proceed with 

5 in the next semester. I will run through some of 

6 these very clearly.

7 But it was a call to make sure that our 

8 rules of order in order of preference were 

9 outlined.

10 It asked for more guidance and detail 

11 on the level of timeliness of Subcommittee notes.

12 It asked for us to adopt a public 

13 communications policy from 2012.

14 It wanted us to define certain terms 

15 that we use throughout the document.

16 It wanted us to issue guidance to the 

17 Secretary on appointments of members to the NOSB.

18 It wanted clarity around voting and 

19 elections of officers.

20 It wanted the -- actually, I added this 

21 myself -- voting record as part of the minutes, just 

22 to make it explicitly clear that this voting record 
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1 is well-maintained, gets published at the same time 

2 that the minutes do.

3 I am down to like five slides. I'm 

4 going. I'm going.

5 Clarification of the roles of the DFO 

6 and the Community Management Officer.

7 Publication of voting records with the 

8 meeting transcripts. I doubled that one up.

9 Minutes for the administrative team. 

10 Meeting minutes. That we completely comply with 

11 all sections of FACA. There is a section that is 

12 not in either version talking about documents 

13 provided to the Committee should be published as 

14 well as part of the minutes.

15 There was a call to add a memo from the 

16 General Services Administration that clearly 

17 outlined the requirements of FACA to CMOs. That 

18 is not us. That is the Community Management 

19 Officer, about release of FACA information. But, 

20 again, we are a very transparent Board. We support 

21 FACA and its requirements, and I think this is a 

22 good addition that we should consider.
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1 Timing of public comments and 

2 publications, as well as the hiring of a Staff 

3 Director.

4 So, in summary, several slides later, 

5 again, it is about balancing of these tensions. 

6 Nothing is perfect. The objectives are these. 

7 The Subcommittee thinks we have achieved them.

8 And it is a balancing, when you look at 

9 this, I mean, it is like a Venn diagram. You've 

10 got compliance with OFPA and FACA. That is pulling 

11 us in one way. We have consistency with tradition 

12 and history. That is pulling us another way.

13 And we need a document that prescribes 

14 and describes our operating procedures. There is 

15 a tiny, tiny triangle there in the middle that we 

16 are hoping will be proposed PPM.

17 That's all I've got at this time.

18 (Applause.)

19 With that, the PPM comes before the 

20 Committee as a seconded motion from the 

21 Subcommittee. It was moved by myself and seconded 

22 by Jean -- Tracy, seconded by Tracy.
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1 I do want to address one more item, 

2 which was there has been calls to ask, can we put 

3 this off for yet another meeting and vote on it in 

4 the fall? I do not support that at this time, and 

5 I will give you my reasons why. It is twofold.

6 One is the comments from the first 

7 meeting to the second meeting were substantially 

8 similar. We have now addressed them twice. I 

9 don't know why we would think comments this third 

10 time would be substantially different. This 

11 document is not a final document. We will continue 

12 to revise it and improve it as time goes forward.

13 And ultimately, in the fall there will 

14 be a new Administration elected, and we don't know 

15 who that Administration will be. Right now, we do 

16 know who the Administration is, sitting two people 

17 down from me.

18 And this is a document that we have all 

19 agreed upon. It is one that we can pass and approve 

20 and set into motion immediately.

21 The second issue I have is, as we had 

22 the excluded methods folks here on the panel, I was 
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1 thinking to myself, man, we really saddled Zea with 

2 a lot of work and we haven't done our fair share 

3 on this. And I was thinking to myself, why haven't 

4 I done my fair share on this? And it is because 

5 I have been spending too much on that document and 

6 those 80 slides.

7 I want to get back to doing the work of 

8 this Board, which is excluded methods. It is 

9 reviewing all the comments we got on carrageenan 

10 and substances. It is about taking on these new 

11 items we have before us. It is about the 

12 evaluation of inspectors and whether or not that 

13 procedure is appropriate. I want to get back to 

14 that stuff. I don't want to spend more time 

15 digging into areas that we have already discussed 

16 and addressed.

17 So, with that, I will now open the 

18 discussion and I will stop talking.

19 Let's see. Harriet? Then, Jean.

20 MEMBER BEHAR: Well, I'm going to vote 

21 for this because I want to honor the tremendous work 

22 that has happened here on the Board. But, also, 
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1 in discussion that there is acknowledgment that 

2 this is a living document and that I will be able 

3 to give some input and do some tweaking, which we 

4 all know it still needs.

5 VICE CHAIR CHAPMAN: Thank you.

6 MEMBER RICHARDSON: Yes, I shall be 

7 supporting this document. I started on the Policy 

8 Development Subcommittee as a newbie 

9 four-and-a-half years ago and spent a year on that. 

10 It was a bit frustrating and I asked to go off it, 

11 although I continued to work through the 

12 Subcommittee periodically.

13 And certainly, what I see now coming out 

14 of this -- and I am presently on this Policy 

15 Subcommittee as well, and for a few minutes I was 

16 Chair of it a couple of years ago -- I see this as 

17 a living document. I think it is critically 

18 important that we pass it today. I don't agree 

19 with every section of it or every sort of phrase 

20 in it, but I think it is a terrific advance over 

21 what we have had before.

22 I think that it demonstrates that, in 
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1 fact, we have strengthened the collaboration

2 between the NOP and the NOSB, although it is not 

3 something that just happens naturally. You have 

4 to keep working at it.

5 And so, I am just delighted that we have 

6 gotten this far with it and thank Tom very much for 

7 his leadership the last few months in putting these 

8 bits and pieces together.

9 Thank you.

10 VICE CHAIR CHAPMAN: Yes. So, I am 

11 going to go with myself. Then, I have Tracy, 

12 Francis, and Zea.

13 I wanted to mention one point I left off 

14 my slide which I think is going to be Zea's question 

15 here anyway. Under the conflicts of interest, 

16 there is a line in there that speaks about that you 

17 shall not receive compensation for speaking, 

18 writing, or discuss teaching for your Board, 

19 related to your Board responsibilities.

20 That is a section taken -- again, that 

21 was word for word, these sections were taken from 

22 guidance set for special government employees. We 
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1 have discussed this with the program, and as 

2 members of the Subcommittee, it is not meant to mean 

3 that I, as an employee of Clif Bar, I guess, I get 

4 paid a salary. And so, while I am here, my salary 

5 is still paid. There is not a way for me to -- I 

6 don't even know how to stop besides getting fired. 

7 I don't know how to stop getting paid. It just 

8 happens.

9 And so, like I am compensated for my 

10 time on the Board. It is not meant in that regard. 

11 It is meant in the regard, if an organization had 

12 a substance before the Board, invited me to a Boca 

13 Raton, Florida retreat to speak on the item that 

14 was all inclusive, that that was not an appropriate 

15 duty of the Board.

16 We understand that the wording is not 

17 explicitly clear and we will be taking that up as 

18 well in this next revision. We will be taking it 

19 up in the next revision to make it explicitly clear. 

20 It is still in there as the overall substance, and 

21 it is on us because it is part of the ethics guidance 

22 that we have received so far. But it is not 
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1 enforced in the method of being on people who get 

2 a salary as part of their participation, part of 

3 the Board.

4 So, we had Francis, then Zea. Sorry, 

5 Tracy, Francis, Zea, yes, okay.

6 CHAIR FAVRE: Okay. Like Jean, I was 

7 Chair of this Subcommittee for a little bit. I 

8 just want to say that I found the process to be very 

9 collaborative with the program. There was a fair 

10 amount of push and pull on some of the discussion.

11 I think it was Ayn Rand who said that, 

12 "Compromise means basically nobody gets exactly 

13 what they want." I suppose that is at least 

14 somewhat true on some of the things in here.

15 But I will say there was not a single 

16 thing in this document that we were forced to put 

17 in here by the program. And I completely and 

18 utterly reject the contention that we are 

19 rubberstamping anything that the program has 

20 mandated that we put in here.

21 VICE CHAIR CHAPMAN: Francis?

22 MEMBER THICKE: Well, I certainly 
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1 appreciate all the work you have all put into it, 

2 and it was a lot of work that your Committee did.

3 And a lot of things I can support. 

4 However, I do have some concerns. Ideally, I would 

5 liked to have been able to vote in division out on 

6 major changes, as has been done in the past.

7 There are some parts, major parts, I can 

8 support; for example, changing the sunsetting 

9 procedures in the manual when that is in 

10 litigation. And so, for that reason, I am going 

11 to be voting against it.

12 MEMBER SONNABEND: So, I do support 

13 most of the document. I, however, am not on 

14 salary. I am paid a small amount for a small amount 

15 of the writing I do in preparing proposals and for 

16 the time I spend here speaking.

17 I am really grappling with how I can 

18 vote for something that literally says that I am 

19 violating it already and have been the whole time. 

20 So, I can't vote for that sentence. I just don't 

21 think I can, even if you say it doesn't mean what 

22 it says, but it says it. So, I would respectfully 
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1 ask that you withdraw that sentence or else I will 

2 abstain. I feel like I have to abstain.

3 MEMBER SEITZ: First of all, I also 

4 very much appreciate the thoughtful, careful work 

5 that went into the Policy Manual.

6 I just wanted to ask a couple of 

7 questions and make a statement. When you say, Tom, 

8 that it accurately reflects current operating 

9 procedures, I think you are also implying, though, 

10 that you think our current operating procedures are 

11 in line with FACA and with OFPA. So, it is not that 

12 this is endorsing a different set of operating 

13 procedures, but endorsing or reflecting operating 

14 procedures that are in line with the governing 

15 laws? Is that fair to say?

16 VICE CHAIR CHAPMAN: Correct, with 

17 what we are doing here today, not what is written 

18 in the 2012 PPM. Yes.

19 MEMBER SEITZ: I was curious about, I 

20 think that the conflict-of-interest provision 

21 around the authors of technical reviews makes a lot 

22 of sense. But, from my perspective, I think it is 
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1 also always helpful to know who actually authors 

2 an article, just as in any peer-review publication 

3 you would know the author of the article, not to 

4 say that other aspects of that author who has hired 

5 them or who they work for, or whatever, would be 

6 an absolutely deciding factor in terms of the 

7 quality of the analysis that is presented. I would 

8 just see that as one more factor.

9 But I haven't read the Policy Manual 

10 carefully enough to say -- that wouldn't preclude 

11 our getting information on authors, would it? It 

12 is just laying out the conflict of interest?

13 VICE CHAIR CHAPMAN: The PPM as written 

14 requires that the name of the contracting party be 

15 written on the technical review that we get, and 

16 it requires that the contract comply with the 

17 Federal Acquisition Regulations that we outlined 

18 there. It is silent to the name of the authors.

19 MEMBER SEITZ: And why is there, from 

20 your understanding of practice, that you wouldn't 

21 also have the author's name?

22 MR. McEVOY: Yes, the current 
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1 contracts that we have for the technical reports 

2 are with the organizations that are listed. I'm 

3 sure Lisa Brines knows specifically which 

4 organizations they are. Those are the parties 

5 that names are responsible for meeting the terms 

6 of the contract. So, those names are -- that is 

7 the organization that is meeting the terms of the 

8 contract. And so, therefore, those are the 

9 organizations that are named as the writer of those 

10 technical reports.

11 MEMBER SEITZ: I looked at the sunset 

12 provision, and the term "sunset" to me absolutely 

13 does imply that the substance would lose its status 

14 and need to be reauthorized. However, the wording 

15 in that paragraph underneath where it says "sunset" 

16 is actually fairly ambiguous.

17 As a Board member, of course, I am 

18 frustrated that it is ambiguous, though as a lawyer 

19 I appreciate its ambiguity because it keeps lawyers 

20 in business. Okay?

21 (Laughter.)

22 But that is something that really 
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1 jumped out at me, that the sunset provision is 

2 genuinely ambiguous. I don't know if there was 

3 legislative record that came along with that. 

4 Certainly, it appears to me, again, just from what 

5 has been presented, that there was an early 

6 different interpretation.

7 What I think is interesting, if you flip 

8 it to what it currently is, it obviously makes it 

9 more difficult to delist a substance, which can 

10 have some benefits and drawbacks from a policy 

11 perspective. But I think it probably will make the 

12 Board more careful in terms of its initial decision 

13 to list. Another Board member, Harriet, I think 

14 mentioned that; that if it is harder to delist a 

15 substance, then I think it is incumbent upon all 

16 of us to be very careful about our initial decisions 

17 to list a substance.

18 My only hesitation in voting anything 

19 other than to abstain on this is just simply that 

20 I haven't had time, as a new member, to just 

21 carefully go through the -- I always want to say 

22 "OPA," but I think it's "OFPA" -- to carefully go 
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1 through OFPA, carefully go through FACA. Then, 

2 see the consistency there.

3 But I do appreciate that Tom's 

4 presentation really did sort of carefully lay that 

5 out, and I think there has been some very careful 

6 thinking behind that.

7 So, luckily, I have another few minutes 

8 to decide on my vote here. Okay.

9 VICE CHAIR CHAPMAN: Emily?

10 MEMBER OAKLEY: I want to echo a lot of 

11 those comments. I feel that there is so much in 

12 here that is worthy of a lot of time and 

13 consideration, that I don't feel I really had the 

14 time to give it, and trying to just read all those 

15 nearly 3,000 comments and to wrap my head around 

16 the proposals.

17 But I really appreciate your 

18 presentation. I feel it really, hopefully, 

19 resolved some questions. I know it won't have 

20 resolved nearly all of them.

21 I think my main concern is just the 

22 conflict that has been generated around the issue, 
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1 and I did write some thoughts down. So, I just want 

2 to actually read them, so that I capture my ideas 

3 best.

4 But, like everyone else, I deeply 

5 appreciate the work that has gone into this 

6 because, having been a board president of a number 

7 of organizations in the past, I know how difficult 

8 this, and I have been through bylaw updates myself, 

9 and it is never an easy process trying to bring 

10 something up-to-date while also respecting and 

11 observing the historical context of the document.

12 And I know that a lot of the work that 

13 you have done has taken place before my time on the 

14 Board. So, that makes my opinion limited.

15 I agree that the PPM needs to be brought 

16 up-to-date, and there are many important 

17 improvements in this proposal. I also, as a new 

18 member, saw that the old version needed help.

19 I also understand that boards and 

20 operating procedures evolve with time, and as 

21 members change, bylaws or in this case the PPM help 

22 preserve the institutional memory of a board and 
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1 reflect the work of earlier iterations of the 

2 board.

3 My concern is that there are changes to 

4 the PPM that remove language that a number of 

5 stakeholders, farmers, consumers, and 

6 organizations, value and want to see kept.

7 I wish that a middle ground could be 

8 found that brings the PPM up-to-date while 

9 preserving more of the language that has sparked 

10 concern and conflict. I am not sure if that is 

11 possible because you all have been through this 

12 process much longer than I have. And it is a very 

13 confusing issue for me. Hopefully, there will be 

14 some more discussion before we vote.

15 MEMBER RICHARDSON: Call the question.

16 MEMBER THICKE: One more comment 

17 quickly on that thing about the authorship of the 

18 TRs. I think it would be great. Because I know 

19 when I read a scientific article, I look at who the 

20 author is. Is he an engineer? Because, then, you 

21 can see where the weaknesses might be, and it would 

22 help kind of, I think, when we evaluate the TRs, 
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1 it might help to know who the authors are.

2 VICE CHAIR CHAPMAN: Thank you.

3 So, the question has been called.

4 Jean, will you withdraw your question 

5 calling?

6 MEMBER RICHARDSON: Yes.

7 VICE CHAIR CHAPMAN: Okay.

8 MEMBER AUSTIN: You know, how come that 

9 side of the room has been hogging all of the time?

10 (Laughter.)

11 We have been over here like for the last 

12 35 minutes. Not really.

13 VICE CHAIR CHAPMAN: I didn't see.

14 MEMBER AUSTIN: But, no, I just wanted 

15 to comment that I support the changes. I support 

16 the effort that has gone into it.

17 I think it puts us back into a point of 

18 balance that better serves the organic community 

19 and all stakeholders, not just an active few. 

20 These are changes that are long overdue. And I 

21 want to go on the record to say that these are good 

22 changes for the entire organic community as a 
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1 whole, as far as I am concerned.

2 And I applaud the work that the 

3 Subcommittee has done to this. Thank you, guys, 

4 for all of your effort on putting this together and 

5 bringing it to a vote before us.

6 VICE CHAIR CHAPMAN: Thank you.

7 MEMBER AUSTIN: And I will support it, 

8 by the way.

9 VICE CHAIR CHAPMAN: Thank you.

10 Seeing no additional comments, move to 

11 a vote on the item.

12 Emily, I believe.

13 CHAIR FAVRE: Yes, our new Board member 

14 Emily is up first for the vote.

15 MEMBER OAKLEY: This is really unfair, 

16 but I am going to vote no.

17 MEMBER THICKE: No.

18 MEMBER AUSTIN: Absolutely yes.

19 MEMBER BUIE: Yes.

20 MEMBER BECK: Yes.

21 MEMBER SWAFFAR: Yes.

22 MEMBER ROMERO-BRIONES: Yes.
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1 MEMBER DE LIMA: Yes.

2 VICE CHAIR CHAPMAN: Yes.

3 MEMBER SEITZ: Abstain.

4 MEMBER RICHARDSON: Yes.

5 MEMBER BEHAR: Yes.

6 MEMBER SONNABEND: Abstain.

7 MEMBER RICE: Yes.

8 CHAIR FAVRE: The Chair votes yes.

9 MEMBER DE LIMA: That's 11 yes, 2 no, 

10 2 abstentions. The motion passes.

11 VICE CHAIR CHAPMAN: All right. We 

12 have one more item before us. Can we toss up the 

13 slide?

14 MEMBER SONNABEND: Point of order.

15 VICE CHAIR CHAPMAN: Yes.

16 MEMBER SONNABEND: Well, now that it is 

17 passed and I'm in violation of it, and there is no 

18 censure policy in the PPM, would you like to take 

19 some censure action against me?

20 VICE CHAIR CHAPMAN: No, because you 

21 were in violation before because it was part of our 

22 ethics procedure before we even voted on it. So, 
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1 there is no real change today and yesterday and 

2 before. It has been in the ethics since 2013, as 

3 far as I can tell.

4 MEMBER SONNABEND: We never voted on 

5 it. I don't think I ever voted on it.

6 VICE CHAIR CHAPMAN: Yes, it's in the 

7 Ethics Memo from the NOP from 2013.

8 MEMBER SONNABEND: Did we get to vote 

9 on it?

10 VICE CHAIR CHAPMAN: That's what you 

11 make your disclosures of conflicts of interest 

12 against. That's that procedure.

13 MEMBER SONNABEND: Well, I will get 

14 ready for the court-martial.

15 (Laughter.)

16 VICE CHAIR CHAPMAN: All right. So, 

17 the next item is the --

18 MR. McEVOY: You're not in violation. 

19 You're not in violation of anything. Well, you 

20 might be of something, but you're not in violation 

21 of the FACA and NOSB rules by taking compensation.

22 (Laughter.)
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1 It's the compensation from the USDA 

2 that is prohibited.

3 VICE CHAIR CHAPMAN: He said the 

4 compensation from the USDA was what was prohibited.

5 All right. So, the 2017 sunset 

6 timeline reorganization, I'm going to address this 

7 as quickly as I possibly can. There's only 45 more 

8 slides on this.

9 (Laughter.)

10 No, this is the only slide.

11 So, this was a discussion document, and 

12 I do want to highlight that the PDS, our proposals 

13 were very ambivalent, one that had a lot of various 

14 comments and opinions, one that was very unanimous.

15 So, everyone across the community 

16 agreed in unity and alignment that something needed 

17 to be done. One commenter said, "Just do it." 

18 They were in support of Proposals B and C, which 

19 was various different ways of clumping with the 

20 2017 items together and, then, moving the reviews 

21 earlier across years '18, '19, '20, and '21 and '22.

22 So, the next action of the Subcommittee 
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1 will be to take all that public comment in and to 

2 see if we need to rearrange some of the proposed 

3 groupings and, then, bring that back to the Board.

4 A couple of themes was that materials 

5 did need to be reviewed prior to their five-year 

6 requirement, which would also be required by OFPA; 

7 that the reviewed materials for removal would not 

8 be removed until their original sunset date, which 

9 would be 2022. Yes, that's the right date. And 

10 that decisions should be made based on current 

11 information, not future information. And then, 

12 there were several suggestions for how we group 

13 those items together.

14 So, that is it for the policy. Is there 

15 any discussion of our 2017 sunset?

16 (No response.)

17 Seeing no discussion, I hand it back 

18 over to the Chair.

19 CHAIR FAVRE: Thank you, Tom.

20 I just want it on the record that we 

21 probably would have ended tonight if you hadn't 

22 brought 80-something slides on the PPM.
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1 All right, folks. That concludes our 

2 agenda today.

3 I want to remind everybody that there 

4 is an OTA reception that actually started at six 

5 o'clock. Hopefully, they still have some food and 

6 drinks left for those of us here.

7 The directions are outside. There's 

8 some postcards, I believe, that have directions. 

9 It is about a 10-minute walk or so to get there. 

10 It is at the Zoo. So, it should be a great venue, 

11 and they have asked me to make sure everybody knows 

12 that they are invited. The directions are outside 

13 on one of the tables, and you can always grab one 

14 of the OTA people if you have any questions.

15 We will reconvene tomorrow morning at 

16 8:30 a.m. We look forward to seeing you all there.

17 Thank you. Have a nice evening.

18 (Whereupon at 6:32 p.m., the meeting 

19 was adjourned for the day.)

20

21

22
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1
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UNITED STATES DEPARTMENT OF AGRICULTURE

+ + + + +

NATIONAL ORGANIC STANDARDS BOARD

+ + + + +

SPRING 2016 MEETING

+ + + + +

WEDNESDAY

APRIL 27, 2016

+ + + + +

The Board met in the Blue Room of the 

Omni Shoreham Hotel, 2500 Calvert Street, N.W., 

Washington, D.C., at 8:30 a.m., Tracy Favre, Chair, 

presiding.

PRESENT

TRACY FAVRE, Chair

TOM CHAPMAN, Vice Chair

HAROLD AUSTIN

CARMELA BECK

HARRIET BEHAR

JESSE BUIE

LISA DE LIMA, Secretary

EMILY OAKLEY

SCOTT RICE

JEAN RICHARDSON

A-DAE ROMERO-BRIONES

DAN SEITZ

ZEA SONNABEND

ASHLEY SWAFFAR

FRANCIS THICKE
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ALSO PRESENT

MICHELLE ARSENAULT, Advisory Board Specialist, 

National Organic Program

LISA BRINES, National List Manager, National 

Organic Program

EMILY BROWN ROSEN, Agricultural Marketing 

Specialist, National Organic Program

PAUL LEWIS, Director, Standards Division, 

National Organic Program, USDA 

MILES McEVOY, Designated Federal Officer, Deputy 

Administrator, National Organic Program
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A-G-E-N-D-A

Compliance, Accreditation, and Certification

Subcommittee............................. 5

Handling Subcommittee

2018 Sunset Materials

Agar-agar .................................... 25

Animal Enzymes ............................... 28

Calcium sulfate-mined ........................ 31

Carrageenan .................................. 34

Glucono delta-lactone ........................ 76

Tartaric acid ................................ 78

Cellulose .................................... 80

Potassium hydroxide .......................... 95

Silicon dioxide ............................. 102

Colors: Beta-carotene extract ............... 106

Proposals

Sodium and Potassium lactate ................ 114

Oat beta-glucan ............................. 145

Hypochlorous acid ........................... 151

Sodium dodecylbenzene sulfonate ............. 157

Ancillary substances for microorganisms ..... 186

Discussion Document: Nutrient vitamins

and minerals - annotation change....... 208
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Crops Subcommittee

2018 Sunset Substances

Copper sulfate .............................. 216

Ozone gas ................................... 222

Peracetic acid .............................. 225

EPA List 3 - inerts of unknown toxicity ..... 232

Calcium chloride ............................ 235

Proposals

Ash from manure burning ..................... 237

Squid and squid byproducts .................. 241

Hypochlorous acid ........................... 268

Soy wax ..................................... 274

Discussion Document: Prohibition of nonyl

phenol ethoxylates in inerts........... 310

Verbal Update: Inerts Working Group ......... 316

Subcommittee Work Agendas ................... 324

Presentation of Appointment Letters &

Certificates for Incoming Members ........... 338

Other Business and Closing Remarks . . . . . 340

Adjourn
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1 P-R-O-C-E-E-D-I-N-G-S

2 8:31 a.m.

3 CHAIR FAVRE: Good morning, everyone. 

4 Thank you for joining us. This will be our last 

5 day of the meeting.

6 And I see the hardcore folks are here 

7 bright and early on the last morning. Thank you, 

8 we appreciate that.

9 I'd like to open our session today --

10 MEMBER RICHARDSON: A point of order, 

11 Madam Chair, point of order.

12 CHAIR FAVRE: Yes, Chair recognizes 

13 Jean Richardson.

14 MEMBER RICHARDSON: I would like to be 

15 able to embarrass Zea this morning by wishing her 

16 a very happy birthday and inviting us all to sing.

17 (Applause.)

18 CHAIR FAVRE: I do miss the flower 

19 crown that you wore in San Antonio for your 

20 birthday. Happy birthday.

21 We actually have a couple of other 

22 birthdays that we're celebrating for Board members 
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1 this week, but I'm not going to embarrass them by 

2 singing to them. Jean's is on Friday and Carmela's 

3 is on Saturday. So, how about a round of applause 

4 for them.

5 (Applause.)

6 CHAIR FAVRE: Okay, I'd like to kick us 

7 off in the same philosophical vein that we've been 

8 trying to keep this week and turn it over to Lisa 

9 for an inspirational reading. 

10 MEMBER DE LIMA: I'm going to continue 

11 with a poem, but not Robert Frost.

12 This is from a 14th century Buddhist 

13 monk. 

14 "Out of the soil of friendliness grows 

15 the beautiful bloom of compassion,

16 Watered with the tears of joy,

17 Under the cool shade of the tree of 

18 equanimity."

19 CHAIR FAVRE: Thank you, Lisa. Great. 

20 Okay, so we are going to start first thing this 

21 morning with an update from the CACS. Carmela?

22 MEMBER BECK: Good morning. So, this 
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1 past semester the CACS solely dedicated our time 

2 to the wrap-up of the assessment on soil 

3 conservation practices which Scott will present on 

4 shortly.

5 Before moving into this topic I briefly 

6 wanted to make mention of the public comment 

7 provided on the topics of one, inspector onsite 

8 evaluation requirements as outlined in NOP 

9 Instruction 2027, and two, eliminating the 

10 incentive to convert natural ecosystems into 

11 organic production.

12 As Tracy mentioned on Monday the CACS 

13 has added the topic of reviewing Instruction 2027 

14 titled Personnel Performance Evaluations issued on 

15 March 31, 2016, in order to zero in on the 

16 requirements that all inspectors should be 

17 evaluated during an onsite inspection by a 

18 supervisor or peer at least annually to our work 

19 agenda.

20 In summary, public commenters 

21 expressed concern over the lack of clarity from the

22 NOP regarding, one, reasons why infield 
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1 inspections of inspectors are required on an annual 

2 basis and not every three to five years and/or are 

3 not required through use of a risk-based approach.

4 Two, why the NOP has interpreted the 

5 "should" as a "must."

6 Three, clarification has been 

7 requested on the exact nature of the problem the 

8 NOP is trying to solve.

9 Four, commenters asked if there is an 

10 opportunity to better utilize the IOIA report 

11 findings and recommendations on pilot infield 

12 evaluations submitted to the NOP in February of 

13 this year.

14 And lastly, commenters shared that the 

15 impact of the annual infield inspection 

16 requirement is not only financial, but has also 

17 contributed to a reduction in the inspector pool.

18 And secondly, the public has expressed 

19 continued interest in requesting that the CACS add 

20 elimination of the incentive to convert native 

21 ecosystems into organic crops.

22 Commenters stated that instead of 
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1 incentivizing the conversion of native ecosystems 

2 to organic crop production the NOSB should guide 

3 the NOP to place emphasis on converting 

4 conventional land and improving current or former 

5 farmland that has been degraded under non-organic 

6 management.

7 And furthermore it was stated that 

8 until such time that a rule could be put into place 

9 they asked that the NOSB recommend for the NOP to 

10 issue guidance on the issue.

11 The CACS would like to thank the public 

12 for their detailed comments. We look forward to 

13 working on Instruction 2027 and to requesting 

14 addition of elimination of the incentives to 

15 convert native ecosystems to our future work 

16 agenda.

17 And with that I'd like to ask Scott to 

18 provide his report.

19 MEMBER RICE: Thank you, Carmela. I 

20 wanted to touch base this morning on the work that 

21 the CACS has done on the assessment of soil 

22 conservation practices.
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1 And to do that I wanted to start off with 

2 a little bit of background.

3 In April of 2014 the NOP sent a memo to 

4 the NOSB noting that they were aware of some 

5 concerns regarding the use of appropriate soil 

6 conservation practices on organic farms such as 

7 prevention of soil erosion, fencing of livestock 

8 from streams, application of manure on frozen 

9 ground, and over-grazing of pasture.

10 NOP expressed that information about 

11 how certifying agents are assessing soil 

12 management practices may reveal areas that could 

13 benefit from targeted training and tools.

14 This memo requested that the CACS 

15 develop a discussion document to solicit public 

16 feedback on the issue around several specific 

17 questions about evaluating soil conservation 

18 management on organic operations.

19 And they offered a number of questions 

20 to be posed to the community.

21 Just a couple of those questions. How 

22 are certifiers assessing whether production 
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1 practices identified in OSP maintain or improve 

2 soil quality.

3 What tools other than visual inspection 

4 could aid certifiers in evaluating soil management 

5 practices.

6 What are the inspector qualifications 

7 that certifiers seek for evaluating soil 

8 management practices.

9 So in terms of progression of work the 

10 CACS adopted this or took this on beginning in May 

11 of 2014, met to discuss various ideas, how to 

12 address in terms of format, whether that would look 

13 like a discussion document or a proposal, what that 

14 scope would look like, national or regional as well 

15 as other goals.

16 There was a draft document discussed in 

17 subcommittee. We reached out to members of the 

18 community for some perspective on that including 

19 Sarah Brown of NRCS who's now working with Oregon 

20 Tilth Certified Organic on NRCS issues.

21 She offered a perspective on that and 

22 the CACS recognized there was general consensus 
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1 around the challenge of determining compliance 

2 versus non-compliance in this area.

3 A draft document was finalized and put 

4 forth for public comment for the fall 2014 meeting.

5 We received a number of comments 

6 indicating certifier and inspector soil assessment 

7 practices are effective and compliant with the 

8 regulation.

9 Current certifier soil assessment 

10 qualitative practices are working, that there is 

11 an opportunity for the NRCS and NOP to collaborate 

12 on developing any additional training.

13 And a lot of discussion around the fact 

14 that there's no codification of NRCS or other 

15 agency's requirements within the regulation, and 

16 that certifiers cannot enforce NRCS requirements.

17 Also some concern around establishing 

18 metrics which were acknowledged to be helpful, but 

19 that there are no benchmarks identified in the 

20 regulation.

21 And with complex farming systems, 

22 making non-compliances based solely on metrics is 
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1 somewhat difficult.

2 There's general acknowledgment that 

3 growers recognize soil degradation when they see 

4 it and will generally act to correct the issue with 

5 recognition that soil is the foundation of their 

6 operation.

7 Some of the suggestions that came out 

8 in those comments were to create NOP and NRCS 

9 partnerships, trainings, guidance, or education 

10 opportunities for certifiers and growers.

11 Create IOIA, International Organic 

12 Inspector Association webinars for ongoing 

13 continuing ed.

14 Perhaps require an inspection every 

15 several years dedicated to assessing soil 

16 conservation practices.

17 Through October and November of 2014 

18 there was discussion of public comments and 

19 considered with the thought of a spring 2015 

20 proposal.

21 There were some further meetings with 

22 NRCS to get some more understanding and perspective 
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1 on the issue, and further work on bringing a 

2 proposal forward as it had been delayed until the 

3 fall 2015 meeting.

4 And kind of looking at that proposal and 

5 the comments, the options for moving forward were 

6 reviewed and considered, whether that meant more 

7 info and guidance from NOP, contracting for a 

8 technical review on soils to assess soil health.

9 And then just this last January we met 

10 again and had some further discussion on the status 

11 and best way forward.

12 CACS and NOP felt it's an important 

13 topic, but at this time the NOP suggested that 

14 delaying further work would make the most sense 

15 until they can provide a little more guidance and 

16 resources.

17 But I wanted to emphasize that in the 

18 time since this came to the CACS in early 2014 

19 there's been quite a bit of work in this vein.

20 And many resources and initiatives have 

21 emerged toward assessing soil conservation 

22 practices, and ensuring that this remains a key 
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1 tenet of organic production.

2 The CACS is confident that with a number 

3 of initiatives that are ongoing as well as 

4 developing we can continue to build some robust 

5 monitoring and assessment of soil conservation and 

6 health across the organic community.

7 And just to highlight some of the work 

8 that has been done in this vein we saw the NOP 

9 guidance 5020, Natural Resources and Biodiversity 

10 Conservation, outlining the roles of the organic 

11 operation, the certifier and the inspector 

12 ensuring an operation has measures in place to 

13 maintain or improve the natural resources 

14 including soil.

15 There have been a number of IOIA 

16 trainings and partnership with NRCS as had been 

17 recommended earlier in this process both with NRCS 

18 and certifiers.

19 IOIA has presented several trainings in 

20 partnership with accredited certifiers providing 

21 inspectors with a greater understanding of NRCS 

22 programs and tools to assess soil health, its 
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1 management and erosion including fuel components.

2 Each year there's an NOP and Accredited 

3 Certifiers Association training that takes place. 

4 And a lot of focus in those, or some 

5 focus in those in the last couple of years has been 

6 on NRCS resources with NRCS staff covering tools, 

7 methods and resources to identify soil health and 

8 management initiatives.

9 We've also got the NRCS CAP 138 program 

10 that presents tools that introduce practices which 

11 assist the producer to transition from 

12 conventional to organic production. And those 

13 plans include a number of initiatives that 

14 encourage and incentivize soil conservation 

15 efforts.

16 As well, a number of Sound and Sensible 

17 projects developed -- or rather funded by -- in the 

18 round of Sound and Sensible projects included 

19 information relating to soil conservation, health 

20 and management.

21 So, you can see there's a lot of effort 

22 on this front. And we're confident that even 
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1 though we're not moving forward with a proposal, 

2 or a recommendation per se that it's been 

3 heartening and great to see all the work that's been 

4 done in this area.

5 And we'll continue to monitor that and 

6 would welcome community input on ways to better 

7 improve. Thank you.

8 MEMBER BECK: Thank you, Scott. Is 

9 there any discussion? Francis.

10 MEMBER THICKE: I just wanted to bring 

11 up something that's happening a lot in the Midwest. 

12 It's been developing for years.

13 It's no-till organic with cover crops, 

14 and probably a lot of you have heard it, where you 

15 grow a cover crop, and then roll it down, and then 

16 plant your annual crop or even vegetables into 

17 that.

18 And I did some last year and had 

19 tremendous results. 

20 It's really great because I think most 

21 organic farmers as Scott said don't want to see 

22 erosion, but they're locked in a little bit because 
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1 to control weeds they have to cultivate.

2 But with this system you're not only 

3 controlling weeds, but you're building soil, 

4 organic matter and you're keeping your moisture in 

5 there. You're building soil structure. All 

6 parameters for soils are improving. So it's 

7 really exciting, I think.

8 And maybe that should be one of our 

9 research topics we forward on too is no-till 

10 organic farming.

11 MEMBER BECK: Thank you. Emily and 

12 then Harriet.

13 MEMBER OAKLEY: I just wanted to say 

14 that I'm really glad to see that you're going to 

15 ask to put the elimination of the incentive to 

16 convert native ecosystems on the work agenda 

17 because I couldn't agree more strongly with that.

18 MEMBER BEHAR: I worked quite a bit 

19 with Jo Ann Baumgartner at Wild Farm Alliance on 

20 this soil conservation.

21 I think there's so much, the perception 

22 too. And the last thing we want is for people to 
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1 drive by an organic farm and see erosion and that 

2 sort of thing.

3 So, we need to really be protecting the 

4 way -- we need to protect organic land and we need 

5 to also protect the reputation of organic, that we 

6 really are good soil stewards. So I think this is 

7 a very important guidance to producers out there. 

8 Especially those new people. Once 

9 they're an organic farmer of course if they're 

10 going to be working to improve their land the last 

11 thing they want to do is see it run down the hill.

12 MEMBER BECK: Miles.

13 MR. MCEVOY: Yes, this was something 

14 that was highlighted by Betsy Rakola on Monday 

15 about the cooperation, collaboration that we're 

16 doing with the Natural Resource Conservation 

17 Service and their efforts to get more information 

18 out about conservation resources that organic 

19 farmers can use and ways to modify their program 

20 so that they're more aligned with organic 

21 regulations and organic principles.

22 So the National Organic Farming 
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1 Handbook has just been published by the Natural 

2 Resource Conservation Service.

3 There is a webinar to introduce that on 

4 May 26 so I encourage people to -- especially Board 

5 members that are working on this topic to sign up 

6 for that webinar session.

7 It's by Lindsay Haines who's the 

8 organic program specialist for NRCS nationwide, 

9 and Ben Bowell who works both for Oregon Tilth and 

10 a cooperative agreement with Natural Resource 

11 Conservation Service. 

12 So, lots of good things happening, but

13 NRCS needs additional input from the organic 

14 community to continue to have their programs really 

15 work well for the organic community.

16 MEMBER BECK: A-dae.

17 MEMBER ROMERO-BRIONES: I have to say, 

18 one of the most helpful papers or documents that 

19 I've read in this space was from the Wildlife 

20 Alliance and their document on food safety that was 

21 funded by NRCS.

22 And I would encourage everybody to read 
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1 that.

2 MEMBER BECK: All right, thank you. 

3 Jean.

4 MEMBER RICHARDSON: Yes, two things. 

5 First, I'd just like to thank people very much for 

6 sending in the information to help us have more 

7 detailed foundation on which to put the wildland 

8 conversation work agenda item, move it closer 

9 towards getting it on our work agenda. 

10 And we'll be taking that up I assume in 

11 our next meeting to get something more formal to 

12 have that go forward.

13 And also, just a reminder that the NRCS 

14 thing on the soils that we did work on over the last 

15 year and a half, one of the things we did note is 

16 that there is a considerable variation 

17 geographically around the country of how the local 

18 NRCS state and regional offices interpret whatever 

19 is in the -- assuming the new national soil document 

20 that's going to be on this webinar which I'll for 

21 sure be on.

22 And so it would be very useful to us. 
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1 Obviously we're not going to leave the soils on our 

2 work agenda per se, but we would really like to get 

3 some feedback from the certifiers over the next 

4 year or so as to how they're moving to sort of 

5 improve their methods of assessing soil, soil 

6 erosion, et cetera, through their OSPs and through 

7 their inspector training and so forth to see how 

8 it's working, and to see what geographical 

9 variations there actually are in the way in which 

10 the improvement of soil and et cetera is taking 

11 place around the country.

12 MEMBER BECK: Anyone else? Okay, that 

13 concludes our report.

14 CHAIR FAVRE: Thanks, Carmela. We're 

15 going to head immediately into the Handling 

16 Subcommittee. Harold?

17 MEMBER AUSTIN: Thank you, Tracy. For 

18 today's presentation for this past semester the 

19 Handling Subcommittee has been working on 18 2018 

20 sunset materials. 

21 We'll be coming forward today with five 

22 proposals, one discussion document.
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1 It's been an interesting semester 

2 following last year. I know some of you in the room 

3 have felt the pain that this Board and especially 

4 the Handling Subcommittee went through and the 

5 other subcommittees with the workload that we had 

6 last year. 

7 It was tremendous, especially doing it 

8 incapacitated in the way that I was with having a 

9 few body parts broken along the way didn't help 

10 matters.

11 But even being physically whole, the 

12 workload that we had before us last year was 

13 tremendous. So, I think we're all still kind of 

14 winding down from that. We're having the 

15 aftershock of the 2017 materials. 

16 So this should be a breeze, but I'm 

17 going to be interested to see how we do.

18 With that, I thank the work of the 

19 subcommittee for everything that we've done, for 

20 the leads taking the time to go through the 

21 materials, for those in the audience and those not 

22 here to provide us with comments, with information, 
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1 helping us to do our job a little bit better as a 

2 volunteer group.

3 The one point I would like to take and 

4 address is when we listed our proposals, whether 

5 they're the sunset '18 materials, or they're our 

6 proposed materials, on many of the materials we did 

7 pose some questions, some very specific questions 

8 back to the stakeholder groups and those involved 

9 in the community.

10 We've got a wide spectrum of responses 

11 back on some materials. On several materials we 

12 got virtually no commentary back to the questions 

13 we posed. 

14 So, I guess I want to challenge 

15 everybody in the organic community that if a 

16 material is up for review or as a proposal, and if 

17 it's important to you, your business, your 

18 stakeholder group, make sure that somebody is 

19 paying attention and that you provide us with any 

20 commentary that you can because it will help us do 

21 a better job of taking and helping support our 

22 organic community.
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1 With that we're going to move into the 

2 first item which will be our 2018 sunset materials. 

3 First up will be agar-agar. Dr. 

4 Brines, if you would be so kind?

5 DR. BRINES: Thanks, Harold. The 

6 first substance on the docket for the NOSB under 

7 handling is on Section 205.605 of the National 

8 List, non-agricultural non-organic substances 

9 allowed as ingredients in or on processed products 

10 labeled as organic or made with organic specified 

11 ingredients or food groups. 

12 Substance appears under paragraph A, 

13 Non-Synthetics, allowed as agar-agar. Thanks.

14 MEMBER AUSTIN: Lisa?

15 MEMBER DE LIMA: Agar-agar uses 

16 include thickener, gelling agent, absorbent. 

17 It's derived from red algae, primarily two species, 

18 Gelidium and Gracilaria. I might have pronounced 

19 those wrong.

20 Agar-agar is permitted for use in 

21 organic production internationally by Codex, the 

22 Commission for European Communities, IFOAM and 
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1 Canada.

2 We did not find any new information 

3 indicating that the substance is harmful to human 

4 health or the environment.

5 We did want to note that this summer the 

6 Handling Subcommittee will be reviewing the use of 

7 all marine plants on the National List currently.

8 And also that in the last review 

9 questions were raised about its classification. 

10 And we will take a look at that once the NOP 

11 finalizes guidance for materials classification.

12 Most public comment that we received 

13 this initial round was supportive of retaining on 

14 the National List.

15 Two organizations did comment that they 

16 would be supportive or neutral if the substance was 

17 annotated from or to agar-agar from the Gelidium 

18 species processed without alkaline.

19 We did request the public inform us of 

20 any new developments with alternatives to 

21 agar-agar. And we got very little response.

22 We did hear that some of the properties 
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1 that made it a good substance was that it had 

2 stronger setting properties than other 

3 animal-based gelatins, and was less 

4 temperature-sensitive than other alternatives.

5 MEMBER AUSTIN: Thank you. Any 

6 discussion or questions from the subcommittee on 

7 what was presented? Do we want to go there? Jean?

8 MEMBER RICHARDSON: Just a quick 

9 question to Lisa. In reading the public comment 

10 on this, I know there wasn't a lot. Do you have 

11 a sense that would guide the public as to what 

12 direction you're headed in terms of continuing to 

13 list?

14 DR. BRINES: Yes, I'm sorry. We would 

15 be supportive of continuing to list because we 

16 didn't get any new public comment indicating that 

17 it didn't fit the criteria to be on the National 

18 List.

19 MEMBER AUSTIN: Any other questions 

20 from the Board?

21 I would just remind everybody that 

22 these are sunset 2018 materials. This is the first 
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1 public posting and discussion for these materials. 

2 The official voting for re-listing or de-listing 

3 will take place at our fall meeting.

4 Moving onto our next material will be 

5 animal enzymes. Dr. Brines?

6 DR. BRINES: Thank you. This 

7 substance is also included under Section 205.605 

8 of the National List under paragraph A, 

9 Non-Synthetics Allowed, and reads as animal 

10 enzymes, rennet, animals derived, catalase, bovine 

11 liver, animal lipase, pancreatin, pepsin and 

12 trypsin. Thank you.

13 MEMBER AUSTIN: Lisa, I believe this is 

14 you again.

15 MEMBER DE LIMA: Animal enzymes. 

16 They're used in very small amounts to carry out 

17 naturally occurring biological processes used in 

18 the processing of foods or ingredients.

19 An example is animal rennet is used as 

20 a coagulant to curdle milk to then be made into 

21 cheese.

22 They're traditionally taken from the 
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1 fourth stomach or other animal organs.

2 The subcommittee asked the public to 

3 comment on the availability of organic animal 

4 enzymes. And comments indicated that none had 

5 been found so far.

6 Public comment was generally in support 

7 of retaining animal enzymes on the National List 

8 with some calls for continued exploration of 

9 finding organic versions.

10 We didn't find any new information to 

11 indicate harm to human health or the environment. 

12 So the subcommittee would be supportive of 

13 relisting at the fall vote.

14 There are no true alternatives to 

15 animal enzymes. They could only really be 

16 substituted with another enzyme that had the same 

17 function.

18 MEMBER AUSTIN: Questions. Harriet?

19 MEMBER BEHAR: So, I did a little 

20 research. I was trying to find if there were any 

21 organic alternatives, and even if some of the 

22 houses that produce these enzymes for cheese 
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1 makers.

2 And I didn't get any response from the 

3 -- you know, I just left little messages. Nobody 

4 got back to me.

5 But I noticed that in Europe they also 

6 are somewhat grappling with this and hoping to find 

7 organic sources of these animal enzymes.

8 We do slaughter the animals that could 

9 produce this enzyme. So I'm hoping maybe in the 

10 next six months we could maybe move further along.

11 And many of the enzymes that are used 

12 in making cheese here in the United States do come 

13 from Europe. So, maybe working with our friends 

14 overseas we could try to see if we could move 

15 ourselves. Wouldn't that be interesting, to 

16 actually have this processing aid ingredient be 

17 from an organic source? And provide another 

18 income stream for the organic producers.

19 MEMBER AUSTIN: Any other questions? 

20 Thank you, Lisa. 

21 Moving on, our next material will be 

22 calcium sulfate mined. Dr. Brines?
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1 DR. BRINES: Thank you. This 

2 substance is also included under Section 205.605 

3 of the National List under paragraph A, 

4 Non-Synthetics Allowed, and reads as calcium 

5 sulfate mined. Thank you.

6 MEMBER AUSTIN: Thank you. Tom, I 

7 believe you're the lead.

8 VICE CHAIR CHAPMAN: So, calcium 

9 sulfate mined is used as a coagulant to food 

10 manufacturing for the soft and silky tofu types.

11 It can be used as a yeast food, dough 

12 conditioner, a water conditioner in brewing, a 

13 firming agent in canned foods.

14 It can also be used in baking powder as 

15 an abrasive agent as well as in cosmetic products 

16 and toothpaste.

17 Calcium sulfate can be obtained from 

18 natural sources or synthetic sources. De-listing 

19 restricts calcium sulfate to mined sources and 

20 mined gypsum is the primary source.

21 After mining the crude gypsum is ground 

22 and separated. It's normally sold as pure, but may 
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1 contain impurities from the mining source such as 

2 calcium carbonate or naturally occurring silica.

3 Calcium sulfate is widely accepted in 

4 international organic standards include IFOAM, 

5 Codex, EU, Japan, Canada and Mexico.

6 Most of those standards have 

7 restrictions to its use in soy, yeast, or baking 

8 products, but most of them also do not have 

9 restrictions on the source material with the 

10 exception of the EU that prohibits calcium -- not 

11 particularly calcium, but sulfates itself produced 

12 from sulfuric acid.

13 Public comment on this item. There 

14 wasn't any direct comment opposed to listing, but 

15 some called for a restriction in usage to soy 

16 products or similar products as well as a new 

17 technical review to assess health and 

18 environmental impacts.

19 Direct comment and comments through 

20 certifiers noted about 25 operations using this 

21 product.

22 MEMBER AUSTIN: Thank you, Tom. 
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1 Questions? Jean?

2 MEMBER RICHARDSON: Tom, same question 

3 that I asked of Lisa earlier. Based on your 

4 analysis so far to give an indication to the public 

5 where we're headed with this? Like relist or 

6 continue?

7 VICE CHAIR CHAPMAN: Yes, I would 

8 imagine this item would continue listing. It's 

9 fairly non-controversial. It's gypsum. It's 

10 used also on the crop side of the list as well.

11 MEMBER AUSTIN: Any additional 

12 questions? Seeing none we will move on to our next 

13 material. Thank you, Tom.

14 Dr. Brines, if you would please present 

15 us with carrageenan.

16 DR. BRINES: Thank you. This 

17 substance is also included under Section 205.605 

18 of the National List under A, Non-Synthetics 

19 Allowed and reads as carrageenan.

20 In support of the review the Handling 

21 Subcommittee did request the development of a 

22 limited scope technical report.
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1 That report was completed and is posted 

2 and available on the National Organic Program's 

3 website. Thank you.

4 MEMBER AUSTIN: Thank you. Zea, if 

5 you would give the subcommittee's report, please.

6 MEMBER SONNABEND: Okay. Carrageenan 

7 is a complex carbohydrate that's extracted from a 

8 few species of red seaweed as we saw yesterday and 

9 the day before.

10 We got over 800 pages of public comment 

11 about carrageenan, and I am going to give a little 

12 summary of what we know so far.

13 I will say at the outset again what I 

14 said in the report - we have not decided how to vote 

15 on it even in the subcommittee. 

16 And we certainly with so many new 

17 members on the Board haven't even started to ask 

18 anyone who's not on the subcommittee to digest all 

19 this information.

20 And while I have read almost all the 800 

21 pages I had a little trouble getting through the 

22 97-page CV of one guy that was submitted.
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1 But I have not had the time to go check 

2 most of the references contained within those 

3 because we had a very unprecedented 10 days from 

4 the time the comment period closed till now.

5 So, I'm just going to give a summary of 

6 the issues. And I'll probably be an equal 

7 opportunity offender and get everyone mad at me.

8 Because we haven't talked much about it 

9 at committee, just a little, it's the way I see the 

10 overall situation shaping up.

11 So, and if Board members want to stop 

12 me with questions in the middle that's okay, or we 

13 can wait till the end and have discussion.

14 So, these are the subjects I'm going to 

15 cover. As you know, we commissioned a TR 

16 specifically to evaluate the human health aspects 

17 of it, but we have a number of criteria that we have 

18 to address which will be addressed in our second 

19 posting to the extent possible.

20 So, first of all, we received quite a 

21 bit of public comment about the classification of 

22 carrageenan. 
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1 We did state when we reviewed it in 2012 

2 that we're waiting for the final guidance on 

3 classification of materials and then we would take 

4 another look at it.

5 That is still our position. We hope 

6 that it might be out before the fall meeting so that 

7 we can.

8 The public comment indicated that 

9 there's more than one method used to extract 

10 impurified carrageenan, and some of the methods 

11 clearly seem to be non-synthetic while others may 

12 have issues that we will want to take up once the 

13 classification of materials comes out.

14 Okay, we definitely have to consider 

15 the effects on the environment when we issue our 

16 final review. But we have commissioned a separate 

17 technical report to address the impacts on the 

18 environment of the production and harvest of all 

19 types of marine plants.

20 And if that report is received on time 

21 for the fall meeting which I certainly hope it will 

22 be we'll be taking that under consideration when 
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1 we make our recommendation.

2 Okay. So, we got a lot of comment about 

3 bias in the literature and among the people 

4 commenting.

5 And like one commenter said, you should 

6 address the topic of bias head on. So that is what 

7 I'm doing.

8 Both of the sides of this argument, the 

9 sides that have shown some troubling 

10 characteristics and the sides that say that 

11 carrageenan is completely safe have published in 

12 peer reviewed journals.

13 This is a list of just some -- it's not 

14 all of the peer reviewed journals, but the ones that 

15 have major articles about carrageenan, either for 

16 it, showing it's safe, or saying that it may cause 

17 inflammation, glucose intolerance, et cetera.

18 So, you know, I am the scientific 

19 representative on the Board. Yesterday I was a 

20 scientist for molecular biology. Later this 

21 afternoon I'll be a scientist for copper sulfate 

22 and rice ecosystems. Today I'm a scientist for 
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1 carrageenan.

2 I don't know how any of us scientists 

3 on the Board can really say that some of these 

4 publications are biased. The peers who do the 

5 review to get the articles published are sold out, 

6 or not independent, or whatever.

7 And so I'm going to leave it at this 

8 mostly.

9 However, this is the list -- one of the 

10 major sources that is used for information and is 

11 trusted worldwide generally is the World Health 

12 Organization JECFA Expert Committee.

13 On the left side of the screen are the 

14 members of that committee, scientists from around 

15 the world who evaluated the reports.

16 Even though the reports were definitely 

17 funded by industry this group of people reviewed 

18 these reports.

19 On the journals on the previous page I 

20 did not really -- you don't know, I mean I probably 

21 could find out, but it would take a lot of digging 

22 to find out who the peer reviewers were. And you 
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1 probably have to pay money since most of them 

2 charge.

3 But in the JECFA case you can find out 

4 who the peer reviewers were. And the people at the 

5 bottom are the people who wrote the reports on the 

6 studies that were funded by industry.

7 So, it is one level removed from bias 

8 in all the cases of peer reviewed literature that 

9 someone reviewed the studies and hopefully looked 

10 for sound experimental methods, although some of 

11 it really makes you do question.

12 So, I'm just going to read from one of 

13 the comments because I do think this is true. 

14 "Bias in scientific research is 

15 something that all groups must contend with. It's 

16 not an issue that's confined to groups funded by 

17 industry. Academic researchers must also deal 

18 with this issue."

19 And I do want to add that NGOs also must 

20 deal with this issue because the louder they speak 

21 out about subjects the more donations they get.

22 So, my only editorial comment about 
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1 this subject is believe it if you need it, and if 

2 you don't, just pass it on.

3 Okay. A lot of the controversy has to 

4 do with challenging the experimental methods used.

5 The older studies generally do not 

6 distinguish between degraded and undegraded 

7 carrageenan. The degraded forms used in some of 

8 them is what's known as poligeenan which is a 

9 separate CAS number substance extracted with a 

10 strong acid.

11 If the research does not specify what 

12 type of carrageenan they used I think the results 

13 definitely come into question.

14 Carrageenan is a substance that binds 

15 tightly with protein and passes through the 

16 digestive system. Studies in which it's 

17 administered in water without protein or injected, 

18 or introduced artificially into tissues that are 

19 not part of the digestive system are all 

20 questionable in my opinion.

21 And also, we would hope at the very 

22 least that a study would say how it is administered. 
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1 But many studies don't say this from the abstracts. 

2 And so this is the reason why we really need to look 

3 at the full studies in order to evaluate it.

4 The in vitro studies have been 

5 challenged because behavior of cells in test tubes 

6 may not be comparable to in vivo digestive systems.

7 Scientists disagree over which animals 

8 are appropriate test subjects. Rats and mice have 

9 different digestive systems than humans. Piglet 

10 studies have been challenged, and primate studies 

11 which you'd think would be the closest to humans, 

12 but there are quite few in the literature.

13 A key tenet of the scientific method is 

14 that results from one lab should be able to be 

15 replicated by other labs using the same 

16 experimental parameters.

17 So far this has not been directly done, 

18 particularly on the glucose intolerance issue.

19 And while I didn't have time to look up 

20 many of the references, I did look up the four that 

21 were cited as replicated studies to the lab of Dr. 

22 Tobacman and Dr. Bhattacharyya. There were four 
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1 studies cited.

2 One of the studies that was cited as a 

3 replicate had not even started yet, and they were 

4 still seeking test subjects, and the results will 

5 be available in May 2017. This is not a 

6 replication of the work if it hasn't even started 

7 yet.

8 Another of the studies was cited as 

9 being from a different institution, Vanderbilt. 

10 But when you looked up the study it had the same 

11 authors as the University of Chicago lab. That is 

12 not a replicated study from a different lab.

13 Dr. McKim who testified to us the other 

14 day, and this was not one of the four references, 

15 but we asked him to elaborate a bit on his attempts 

16 to replicate.

17 But his studies so far are only in 

18 abstract form and so we didn't look at the full 

19 methods that he used to judge for ourselves if they 

20 were comparable.

21 And he did testify how he thought they 

22 were comparable. But I would very much like to see 
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1 his complete studies. And so if someone in the 

2 audience will know when they're published and could 

3 send them to Michelle that would be great.

4 The two other studies that were cited 

5 were only available as abstracts unless you paid 

6 $35 which I am not about to pay $35 to find out more 

7 about carrageenan at this point.

8 And so you can judge the experimental 

9 methods from the abstract. And one of them was so 

10 jargony I had no idea what they were really studying 

11 and would need to see the paper.

12 The other one, it was clear they were 

13 studying the effect of a virus on rats. And they 

14 used carrageenan as a supplemental method to 

15 exacerbate the virus if you will or potentiate it.

16 And they were not studying the 

17 carrageenan itself, they were studying the virus. 

18 So I do not think that is a replicated study either.

19 And that is my personal opinion. And 

20 I urge you to look at that for yourself.

21 Okay, degradation. You heard a lot of 

22 public comment about how much it degrades in the 
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1 digestive system.

2 The undegraded carrageenan is the type 

3 that's used in food. I've given the molecular 

4 weight range.

5 The poligeenan has a much lower 

6 molecular weight range.

7 The controversy is how much of the 

8 degradation actually occurs in digestion. 

9 Research has shown that it's in a bell curve type 

10 fashion where there might be some at any particular 

11 molecular weight, you know, going along a curve 

12 where the typical molecular weight is in the middle 

13 and then there's some at the low end and some at 

14 the high end.

15 The key question in this is what level 

16 of degradation would be harmful. But since they 

17 can't really isolate the different molecular 

18 weights very well to study them separately that's 

19 not research that's being done.

20 Some studies have indicated that most 

21 of the carrageenan is excreted in the feces. And 

22 there is some question about whether the lower 
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1 molecular weights are absorbed in the intestinal 

2 system.

3 But the hypothesis that degraded

4 carrageenan has been absorbed into tissue has not 

5 been proven.

6 Some studies are published showing 

7 inflammation and other problems, while other 

8 studies have not shown problems.

9 Okay. Inflammation. A series of 

10 studies has shown that carrageenan can induce a 

11 complex inflammatory cascade in human intestinal 

12 epithelial cells. These studies were in vitro 

13 using cells from one individual. 

14 Other studies did not associate 

15 food-grade carrageenan with inflammation.

16 Results are mixed in animal studies 

17 that administered carrageenan through drinking 

18 water.

19 Abilities of carrageenan to bind to TL4 

20 and trigger the inflammatory cascade has been 

21 challenged in the literature.

22 The technical report states, 
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1 "Definitive conclusions regarding the varying 

2 degrees of human susceptibility to inflammation 

3 effects of carrageenan cannot be made from the 

4 available literature." I would tend to agree with 

5 that statement.

6 The NOSB previously looked at an 

7 article published in 2015 by Chassaing, et al., 

8 about the potential for all dietary emulsifiers to 

9 impact the gut microbiota of mice, promoting 

10 inflammation and colitis.

11 I have this study. We looked at it in 

12 when we did the review of lecithin and some of the 

13 other gums in the first posting. And if anyone 

14 wants it I can circulate it to you.

15 And while this article, they only 

16 studied two of the emulsifiers, but they did in 

17 their conclusions draw -- cast a wider net and say 

18 that we don't know. It appears that this could be 

19 the case for all emulsifiers just because of the 

20 way they work in the human gut.

21 But this is the very beginning of 

22 studying this in terms of equality of all 
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1 emulsifiers, and most of them have not been studied 

2 to the extent that carrageenan has.

3 Sensitivity. In the 2012 sunset

4 review we received public comment from at least 

5 seven people who describe themselves as sensitive 

6 to carrageenan.

7 They experienced an adverse effect that 

8 stopped when they removed it from their diets.

9 In this current batch of public 

10 comments we received more of these reports. I did 

11 not have the opportunity to count them up, but we 

12 definitely did receive more.

13 One of the commenters searched the 

14 medical literature and only found one published 

15 report of an adverse reaction. And it was from 

16 experiencing it as administered in an enema which 

17 is not certainly typical of how carrageenan is 

18 ingested.

19 Many public commenters this time denied 

20 the reality of these complaints because they're 

21 anecdotal and not backed by scientific literature.

22 However, it appears that they're not in 
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1 the literature because they have not been studied 

2 at all. 

3 So, there has never been to our 

4 knowledge a population study on whether these 

5 concerns are attributable to carrageenan, nor is 

6 there any type of study that proves that all humans 

7 are subject to inflammation for this. There's 

8 been no I think Tom called it epidemiological. 

9 That's a word not in my vernacular.

10 But I do think that it was incorrect for 

11 the deniers to deny that these problems are real. 

12 As someone who's very much subjected to problems 

13 from food additives myself, although not 

14 carrageenan, I do admit to the reality of these. 

15 I think it should be studied on a 

16 population basis because for every 50 people with 

17 a stomach ache some of them may be from carrageenan 

18 and some of them not. But to deny that sensitivity 

19 is possible is not realistic because I do think it 

20 is.

21 So, carrageenan is required to be on 

22 food labels with very few exceptions. And 
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1 apparently in beer it's a processing aid. But we 

2 did get testimony about it being in condensed milk 

3 which we would have to look into, I think.

4 Therefore, those wishing to avoid it 

5 have the ability to do so for the most part. 

6 And, as I said, as someone who -- many 

7 of the other emulsifiers that are derived from 

8 legumes I can't go near. And I read food labels 

9 rigorously. And I do still find them snuck into 

10 foods where they're not on the label. So I know 

11 how troubling this will be. But it's something 

12 that you just experience.

13 Okay, alternatives. This is the first 

14 slide. I tabulated the public comments we got and 

15 also some online information about whether the 

16 carrageenan had been able to be replaced in foods.

17 So, the first group of items is the 

18 dairy foods. We got testifiers who were able to 

19 replace it in chocolate milk which is one of the 

20 more popular items that may contain it, and we got 

21 some that said they could not replace it in 

22 chocolate milk.
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1 Whipping and heavy cream. Mostly we 

2 heard from people they were able to remove 

3 carrageenan.

4 Protein shakes with milk proteins was 

5 definitely one that was no. And we got comments 

6 like, "When calcium settles to the bottom of the 

7 container it forms a hard precipitate so no matter 

8 how much you shake it it can't be shaken up."

9 Milk powder - no. Yogurt, sour cream 

10 and cottage cheese, although there's quite a bit 

11 of anecdotes online, but we did not receive any 

12 comments about this.

13 Sugar-free spread used as a gelling 

14 agent. We got some that said yes, they had removed 

15 it, and some that said no.

16 Puddings. Some people said they 

17 couldn't remove it from puddings.

18 From fruit fillings, I guess like pie 

19 fillings. 

20 I guess at least one brand of gummy 

21 bears which I'm not sure how you spell it, but they 

22 have removed it so eat all the gummy bears you want.
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1 We heard on the webinar from a producer 

2 of vegan marshmallows and it is a replacement for 

3 gelatin in that use. And gelatin just is not 

4 vegan. So they could not replace it.

5 Frozen soy desserts. We heard no 

6 replacement.

7 Soy milk we heard both yes and no, or 

8 there is information for both yes and no.

9 Vegetarian capsules for dietary 

10 supplements no because once again, gelatin. 

11 Infant formula, no. 

12 Processed meats, both yes and no. Some 

13 brands have removed it from sliced turkey and ham, 

14 and others not.

15 Non-dairy beverages such as almond milk 

16 and rice milk, both yes and no.

17 And beer as the processing aid, no, 

18 although since we have no idea how many beers are 

19 processed using it I imagine there are some that 

20 do not have it. But we didn't hear from them.

21 VICE CHAIR CHAPMAN: Can I make a note, 

22 we did hear an oral comment that there was heavy 
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1 whipping cream made without carrageenan.

2 MEMBER SONNABEND: I think I said that.

3 VICE CHAIR CHAPMAN: Did you say that?

4 MEMBER SONNABEND: Yes.

5 VICE CHAIR CHAPMAN: I thought that was 

6 a no.

7 MEMBER SONNABEND: No. I'll go back. 

8 Whipping and heavy cream, yes.

9 VICE CHAIR CHAPMAN: Oh you said yes, 

10 okay.

11 MEMBER SONNABEND: Okay. The 

12 Handling Committee will fully evaluate all the 

13 public comment received between now and the fall 

14 meeting.

15 Any new published research studies, but 

16 research studies only, not opinions, please, send 

17 to Michelle Arsenault.

18 Please provide actual text and not just 

19 abstracts so we don't pay $35 all the time. 

20 Although the government can get us some of the 

21 literature, but usually not with a lead time 

22 between getting to the meeting and making this 
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1 presentation.

2 So, there will be another comment 

3 period open in October before the fall meeting and 

4 we encourage more comments in that time regarding 

5 the alternatives to the use of carrageenan.

6 So, it's open for discussion.

7 MEMBER AUSTIN: Thanks, Zea, for 

8 bringing forward such a great presentation on such 

9 a complicated material. 

10 Questions from the Board for Zea? 

11 Francis?

12 MEMBER THICKE: Just a comment. 

13 Sometimes I have to wonder how essential things are 

14 like heavy whipping cream.

15 We make heavy whipping cream and it 

16 never crossed our mind that we should put 

17 carrageenan in it. It's cream, I mean.

18 MEMBER SONNABEND: Well, that's one 

19 that has been successfully taken out.

20 MEMBER THICKE: Right, I understand 

21 that.

22 MEMBER SONNABEND: I mean, something 
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1 like pie filling, I'm sure you make pie all the time 

2 and don't use carrageenan. But a processor who has 

3 to have it on the shelf, or freeze it, or whatever 

4 they're doing to it says they can't do it.

5 So, yes, that's what our job is is say 

6 should I make my own pie or buy pie with carrageenan 

7 in it.

8 MEMBER AUSTIN: Ashley?

9 MEMBER SWAFFAR: So, I do question the 

10 essentiality of carrageenan also.

11 Zea, do you think that they can make 

12 carrageenan organically? Can they have a 

13 certified organic product?

14 MEMBER SONNABEND: Well, yes. Once 

15 the -- I believe we have to have the aquaculture 

16 standards in place which will then affect plant 

17 products. No? Okay.

18 Well, but it's not wild harvested, it's 

19 farmed. And there's no rotation, for instance. 

20 Well anyway, the answer is there is some 

21 certified kelp on the market. And there's no 

22 reason why seaweed which is also a kelp couldn't 
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1 be produced that way, except not being on the 

2 certifying end of certifying any seaweeds I 

3 couldn't tell you what the issues are.

4 We could maybe ask some of the 

5 certifiers in the room who certify seaweeds what 

6 they use for standards. Maybe Scott could work on 

7 that between now and fall.

8 But yes, it should be able to. But you 

9 know, as the gentleman said who testified yesterday 

10 there hasn't been any need for them to. 

11 And that would mean moving it to 606 

12 instead of 605(a) which I don't know if that would 

13 make the people who want us to remove carrageenan 

14 from food happy.

15 VICE CHAIR CHAPMAN: If it was 

16 certified it wouldn't need to appear on 606.

17 MEMBER SONNABEND: True. True. But 

18 would that make the protesters happy?

19 VICE CHAIR CHAPMAN: I doubt it.

20 MEMBER DE LIMA: Thank you, Zea.

21 MEMBER AUSTIN: Any other questions? 

22 Harriet.
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1 MEMBER BEHAR: So, I see on this, and 

2 you know, really the next six months I'll have even 

3 more time to digest and think about this.

4 But the fact that it's on the National 

5 List now and people are using it makes it a lot more 

6 difficult to remove it.

7 But on the other side since there are 

8 many studies that say that it causes problems so 

9 we think about the precautionary principle. And 

10 do we really want to have something that could cause 

11 harm to some or many people? It's a very difficult 

12 decision. I haven't made up my mind yet.

13 But I think the fact that it's already 

14 on the list and so used it's really a lot of yanking 

15 the rug out from under people. But everyone who's 

16 using it should at this point know that we are in 

17 strong deliberation on it. So hopefully if it does 

18 come off it wouldn't have as negative an impact as 

19 maybe some other sunset items where people aren't 

20 as aware.

21 MEMBER SONNABEND: You know, it's the 

22 issue of is -- for everything on the list probably 
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1 some people have negative reactions to it.

2 How universal this is is to me just not 

3 totally proven. And you have to weigh -- if you 

4 use the precautionary principle on everything 

5 there would be very few things on the list. 

6 Because you can always find an issue about every 

7 single thing.

8 So, yes, we're struggling with really

9 tough issues.

10 I do not feel that the absolute harm is 

11 proven, personally. And I do think there's a lot 

12 of misleading statements going on about what the 

13 research has actually shown so far. 

14 And the scientists are fighting 

15 bitterly about this which makes it hard for us to 

16 say which scientist is right or not.

17 So that's why I really think everyone 

18 should read some literature for themselves.

19 And for people who want only the most 

20 -- what I consider the most key references on both 

21 sides I'm happy to point you in that direction 

22 instead of all I think 3,000 studies or something.
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1 I think you could read a dozen and get 

2 the gist of it.

3 MEMBER AUSTIN: Tracy?

4 CHAIR FAVRE: There's a few of us on 

5 this Board who've had the pleasure of having to 

6 debate this twice now because of the way the timing 

7 came up on sunset.

8 And I for one am really thankful we have 

9 the new process where we have two meetings to 

10 discuss it. Because you can imagine my first vote 

11 on this was my very first Board meeting in April

12 after I came onboard in January. So, not a whole 

13 lot of time to digest it.

14 The struggle for me is it's already been 

15 reiterated here by other people, but we have 

16 competing studies.

17 The point about the precautionary 

18 principle is well made, Harriet. But I also think 

19 the strongest argument against arbitrarily making 

20 the decision about the precautionary principle, 

21 and I don't mean it as an arbitrary just whatever, 

22 is if it's listed on the ingredient panel you do 
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1 have an opportunity to avoid it.

2 I would have a significant heartburn 

3 about it if it was in a product that's not listed 

4 like we've discussed in beer. And I don't think 

5 we have a clear understanding. Yes, it could be 

6 considered a processing aid, but is there any 

7 residual left in the product. We don't really know 

8 that yet. Although maybe if you're drinking beer 

9 you don't really care about what it does to your 

10 stomach.

11 So, some of the things that I was 

12 thinking about seeing in one of the environmental 

13 seats on the Board is the impact from the harvest.

14 I thought there was actually some 

15 pretty interesting information presented in public 

16 testimony over the last few days.

17 When asked with one of the presenters 

18 if it was a monoculture she answered yes, but at 

19 the same time she also talked about it being a 

20 nursery environment for other aquatic species 

21 which I actually think is kind of encouraging and 

22 could potentially help benefit those ecosystems.
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1 And certainly although it's not one of 

2 the criteria we can evaluate, it certainly provides 

3 livelihood to those farmers and potentially 

4 offsets the more environmentally damaging maybe 

5 overfishing of those fisheries in that area.

6 So this is a very complex issue. I will 

7 have to say I haven't fully decided. And I'm glad 

8 again that we have some time to do it, to figure 

9 it out.

10 MEMBER AUSTIN: Emily.

11 MEMBER OAKLEY: I do want to speak, but 

12 I think that Lisa was first.

13 MEMBER DE LIMA: Two things. One 

14 quick thing. Zea, can you go back to the chart you 

15 had with the products? Because I thought that 

16 somebody had written in a public comment that it 

17 was used in personal care products, but they 

18 weren't more specific than that.

19 MEMBER SONNABEND: I did not include 

20 personal care which toothpaste it's commonly used 

21 in. And I did not include pet food which it's 

22 commonly used in because those are outside our 
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1 scope and the department has said not to evaluate 

2 those.

3 MEMBER DE LIMA: Okay. And then I just 

4 want to give my perspective from the retailer's 

5 seat. 

6 Pretty much if you asked any retailer 

7 would you be sad to see carrageenan go away they're 

8 all going to say no, we'd be pretty happy. This 

9 has been one of the harder things to have a 

10 conversation with a customer about. 

11 I mean, none of us are decided and we 

12 all get the benefit of public comment and all this 

13 time to look at it.

14 You can't really have this conversation 

15 with a consumer. It's just not realistic.

16 And so I'm conflicted because from the 

17 seat I sit in I think most retailers would like to 

18 just not have to deal with having this conversation 

19 with customers anymore.

20 And it was a huge relief to start to see 

21 products, especially the dairy products transition 

22 away. 
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1 At the same time I don't want to go ahead 

2 and start pulling things off the list when it's 

3 debatable scientifically or environmentally and 

4 all the other criteria. 

5 So, I just want to put that out there 

6 as someone that has a lot of interaction with 

7 consumers. We have 90,000 customers come through 

8 our doors every week. And it's definitely up 

9 there. And so it's a hard one for me. 

10 MEMBER AUSTIN: Thanks. Emily.

11 MEMBER OAKLEY: I would touch on some 

12 of that. I think that although consumer 

13 perspective isn't a criteria and we have to look 

14 at the science which is of course conflicting I 

15 think we do need to take into account public 

16 perception.

17 And even though the public has varying 

18 degrees of education on this issue it's definitely 

19 integral in terms of their perception of the 

20 organic label.

21 Now, how many people deeply care about 

22 it? I don't know. But I do know that some of that 
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1 can spill over just in a broader public arena, 

2 whether it's intended or whether the Board wants 

3 it to or not into perception, which can have a 

4 spillover effect in many other areas which I can 

5 elaborate later.

6 But one thing I wanted to address in 

7 terms of Tracy's issue is that even though I don't 

8 necessarily know that as a farmer representative 

9 on the Board I represent those farmers that is 

10 definitely something that brought me to 

11 agriculture in the first place, working with 

12 farmers throughout the world.

13 And I plan on doing some research. And 

14 I'd like to share with the committee and at the next 

15 meeting some of the farmer perspective on that, and 

16 whether or not some of these claims are completely 

17 accurate in terms of livelihood issues.

18 MEMBER AUSTIN: Jesse.

19 MEMBER BUIE: Zea, how many of those 

20 studies for and against have been replicated?

21 MEMBER SONNABEND: Well, with the 

22 really huge number of studies I haven't looked at 
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1 every single one to see if it's replicated.

2 I'm just saying that especially the 

3 most recent ones that show diabetes precursors and 

4 glucose intolerance, those have not been 

5 replicated.

6 But keep in mind that this is being very 

7 actively researched, and the research group from 

8 Chicago is publishing two to four papers a year. 

9 And the other people are also publishing quite a 

10 lot of papers all the time. So, possibly by the 

11 next meeting some replication results will come 

12 out.

13 MEMBER BUIE: I think that will start 

14 to help us to make some decisions if we can get some 

15 repetitive accounting of the reports.

16 MEMBER AUSTIN: Zea, then Tracy, then 

17 Jean.

18 MEMBER SONNABEND: Okay, I want to 

19 mention for the sake of discussion the Board does 

20 have the option to restrict carrageenan to certain 

21 uses by an annotation.

22 The annotation will have to come at the 
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1 next meeting as a separate proposal, or it could 

2 come at any future meetings as a separate proposal.

3 Right now to me the clear products that 

4 do not have options are the gelatin replacement 

5 ones, the vegan marshmallows and the capsules for 

6 dietary substances, and then also the infant 

7 formula does not seem to have a clear replacement.

8 But it would be the option of this Board 

9 to allow it in vegan products, or to craft an 

10 annotation that would limit its use to just those 

11 products where there is not a replacement yet.

12 MEMBER AUSTIN: Tracy.

13 CHAIR FAVRE: As Lisa was making her 

14 comments about the retailer's perspective it 

15 occurred to me that some of this might actually be 

16 moot if we let the market demand drive the product 

17 formulations to a certain extent.

18 I don't think there's any question that 

19 the formulators out there are seeing this and 

20 feeling this. 

21 If it had never been on the list, if I 

22 was here today in this seat and it was coming to 
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1 us as a petition I think my decision would have been 

2 much easier.

3 The fact that it's already on the list 

4 and there are companies and manufacturers and 

5 retailers that are using this product makes it in 

6 some ways more difficult to assess the impact.

7 But I also think since it is listed 

8 again people do have the option to avoid it. And 

9 while that's probably not the ideal circumstance 

10 it may by its own consequence just eventually fall

11 out of use in organic products.

12 MEMBER AUSTIN: Jean.

13 MEMBER RICHARDSON: Thank you. I was 

14 going to raise the issue of a potential for an 

15 annotation as well, Zea. Maybe it is something 

16 that we should look at for the fall as well.

17 But my question is to Lisa. Lisa, you 

18 do the buying of product, right? Part of what you 

19 do in the retailer world that you work in.

20 Can you describe to us then what sort 

21 of has happened with carrageenan holding products? 

22 You've had consumers coming in, reading the label 
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1 and saying get rid of that. We want X. To give 

2 us greater detail of how things are phasing out.

3 MEMBER DE LIMA: Yes, I mean that's the 

4 general sense, that consumers don't want to see 

5 that in the products.

6 I mean, I can't -- people are asking 

7 whether manufacturers had seen a slide in sales 

8 when they had taken it out. And I can't answer that 

9 for the manufacturer. I can only say from our 

10 perspective we haven't seen a big shift in sales 

11 to the negative when that's happened.

12 I mean, I can dig in and go SKU by SKU 

13 and bring some information to the subcommittee, but 

14 still that's only representative of our consumer 

15 base, not everybody's consumer base.

16 It's kind of awkward, but something 

17 that I've talked about with our sourcing team is 

18 sometimes we'll talk about yes, we've got this 

19 ingredient, whether it's carrageenan or something 

20 else that we're not sure we want to allow in 

21 products, but we've already got all these products 

22 on our shelf. 
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1 And so sometimes we'll just talk about 

2 new products. And we'll say well, let's create a 

3 standard for new products and say we're going to 

4 deal with the existing products at some point, but 

5 for now any new products come in we might not allow 

6 carrageenan or another ingredient with that.

7 The problem with doing that is when it's 

8 on the National List it just looks kind of weird. 

9 It's a hard thing to say well, we're not going to 

10 allow it in products, but they are allowed in 

11 organic products. And so we haven't gone there in 

12 this case because it's a really awkward 

13 conversation to have with a customer, that it's 

14 allowed in organics but we're not going to allow 

15 it.

16 So we haven't gone there and we are 

17 taking new products. But there's definitely a lot 

18 less new products coming in, organic ones that have 

19 carrageenan in it.

20 VICE CHAIR CHAPMAN: Can I ask a 

21 follow-up question to this?

22 MEMBER AUSTIN: Sure.
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1 VICE CHAIR CHAPMAN: Have your 

2 consumers been asking about other, the like 

3 replacement gums or other gums? Carrageenan by 

4 far is the standout?

5 MEMBER DE LIMA: I haven't heard 

6 anything about other gums so far. So far.

7 MEMBER AUSTIN: Emily, did you have 

8 another question?

9 Okay, I've got just some points to make 

10 on it as well.

11 This is a difficult topic for all of us. 

12 Having been the lead on it in 2012 at that April 

13 meeting when it was supposed to be such a benign 

14 material, then to get lambasted like we did with 

15 -- that it's not quite as simple an issue around 

16 this as we thought.

17 A couple of things I'll point out is 

18 when we looked at it and we renewed it back in 2012 

19 we had environmental concerns with the material as 

20 far as how it was being harvested.

21 I think we've seen some presentations 

22 from some of the farmers. 
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1 The reason I asked the one question 

2 yesterday was I did want to try to ferret out what 

3 it was doing to the environment in the waters where 

4 these materials were being harvested.

5 And it does, I think Tracy you alluded 

6 to it a little bit that it does seem like there is 

7 some beneficial parts to this that we weren't 

8 previously aware of back in 2012, that it does maybe 

9 possibly help the environment within the water, and 

10 as some breeding habitat and some other stuff that 

11 we weren't aware of.

12 The other point I want to make is it gets 

13 to a point where we do have a material that's on 

14 the list, and it's a decision that we're going to 

15 have to be faced with this fall, whether we're going 

16 to keep it or not.

17 There are stakeholders that have built 

18 product lines. There are stakeholders that have 

19 worked very diligently to try to remove this 

20 material. Many have removed this material out of 

21 their product lines. Many have not.

22 It comes down to a point, what does the 
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1 organic community look to lose if we can't come 

2 together and decide whether to keep this or remove 

3 it.

4 We're going to have consumers that are 

5 going to lose choices. We're going to have 

6 handlers that are going to possibly lose materials 

7 and market share. We're going to have an organic 

8 industry that possibly faces stepping backwards to 

9 some degree. 

10 So these are all things that we have to 

11 balance in the decisions that we make along with 

12 consumer perspective, human health, environmental 

13 health and all of these other factors.

14 So, we need to place that into a balance 

15 and look at everything when we're deliberating upon 

16 these types of issues and these types of materials.

17 As a handler rep I'm torn. But I know 

18 that there's a lot of people that are out there that 

19 use these materials that are looking to me to take 

20 and watch their backside, and do what I can to make 

21 sure that we make a clear, a just, and the right 

22 decision at the end of the day when we vote next 
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1 fall.

2 And that's on all of us to do the 

3 reading, to follow the research, to listen to the 

4 presentations. 

5 I think this is one material where all 

6 of the Board needs to pay attention to what's taking 

7 place this coming semester in the Handling 

8 Subcommittee, to keep as well informed on this 

9 particular material and this issue and topic as 

10 possible.

11 That's all I've got. We're burning 

12 some time so I don't want to take this on too much 

13 longer. Emily.

14 MEMBER OAKLEY: I just want to make one 

15 brief comment.

16 Although this isn't totally parallel, 

17 I think the environmental benefits should be looked 

18 at closely. That as a farmer I till up land, and 

19 while that might provide habitat for some frogs or 

20 some turtles, and they might move in there, I 

21 wouldn't ever say that what I've created in my farm 

22 ecosystem is better than the native ecosystem. 
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1 And I think we should look at that in 

2 terms of this as well. If there are environmental 

3 benefits it can't possibly be greater than a 

4 natural ecosystem.

5 MEMBER AUSTIN: Zea, probably final 

6 comment on this.

7 MEMBER SONNABEND: Just, yes, one 

8 concluding comment.

9 This presentation is available to us 

10 through our normal repository for files under the 

11 NOSB presentation folder. And it will stay there 

12 after the meeting if you do want to refer to it.

13 MEMBER AUSTIN: Thanks, Zea. Great 

14 discussion on an extremely difficult topic.

15 Moving on, glucono delta-lactone. Dr. 

16 Brines.

17 DR. BRINES: Thank you. This 

18 substance is included under Section 205.605 of the 

19 National List, also under paragraph A, 

20 Non-Synthetics Allowed, and reads as glucono 

21 delta-lactone, production by the oxidation of 

22 D-glucose with bromine water is prohibited.
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1 In support of the review this round the 

2 Handling Subcommittee did request the development 

3 of a new technical report. That report was 

4 completed and is available to the Board and the

5 public on the National Organic Program website. 

6 Thanks.

7 MEMBER AUSTIN: Thank you. Tom?

8 VICE CHAIR CHAPMAN: Thank you. 

9 Glucono delta-lactone herein referred to as GDL is 

10 primarily used in the production of tofu, 

11 particularly in the production of silken tofu.

12 In that production it's used as a 

13 coagulant. It can also be used as a curing agent, 

14 a leavening agent, pH control agent, and a 

15 sequestrant.

16 There's a variety of ways which GDL can 

17 be produced. The most common form has gluconic 

18 acid produced via a process called the Blom process 

19 in which gluconic acid is produced via fermentation 

20 of glucose syrups. 

21 Sodium hydroxide or calcium carbonate 

22 is added to this to produce gluconate salts. The 
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1 gluconate salt is isolated via evaporation, 

2 crystallization, conversion via ion exchange.

3 The process that produces GDL via an 

4 acid-based reactions and fermentations which we 

5 have classically classified as non-synthetic.

6 Other processes to make GDL involve 

7 oxidation with bromided water which is disallowed 

8 -- bromine water which is disallowed by the 

9 annotation, as well as oxidation with purified 

10 enzymes.

11 GDL does not appear on any 

12 international organic certification list that I 

13 could find.

14 Public comment on this. We received 

15 two comments from public interest groups that 

16 questioned the necessity of the substance as well 

17 as the possible presence for GMOs in the 

18 manufacturing process.

19 And we received comment from eight 

20 handlers or trade associations commenting on the 

21 necessity mostly around tofu production. 

22 However, we did receive one oral comment saying 
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1 that it's used in dairy products. So it wasn't 

2 clear to me if that was used in organic dairy 

3 products today.

4 MEMBER AUSTIN: Thanks, Tom. Any 

5 questions from the Board? I don't see any. 

6 Thanks, Tom.

7 Next we will move on to tartaric acid. 

8 Dr. Brines, if you would, please.

9 DR. BRINES: Thank you. This 

10 substance is included also under Section 205.605 

11 of the National List under paragraph A, 

12 Non-Synthetics Allowed, and reads as tartaric acid 

13 made from grape wine. Thanks.

14 MEMBER AUSTIN: Thank you. Ashley, I 

15 believe you're the lead.

16 MEMBER SWAFFAR: Tartaric acid has 

17 many uses including pH control, emulsification, 

18 stabilization, anti-caking and as a firming agent.

19 During the comment period we did hear 

20 from several wine makers on the importance of 

21 tartaric acid in the wine-making process with one 

22 commenter stating that tartaric acid is the single 
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1 most important input allowed in organic wine 

2 making.

3 And we also heard from candy 

4 manufacturers supporting the relisting of tartaric 

5 acid.

6 And there was a question raised whether 

7 tartaric acid made from organic grape wine is 

8 available. And I do plan to add that at the bottom 

9 of our posting next time under the question 

10 section.

11 MEMBER AUSTIN: Thank you. Any 

12 questions from the Board? Tom.

13 VICE CHAIR CHAPMAN: So, I mean, I 

14 think I know the answer to this one, but I was a 

15 little confused.

16 So, it's used in wine and it's produced 

17 from wine?

18 MEMBER SWAFFAR: Yes. There was one 

19 in there, like --

20 VICE CHAIR CHAPMAN: It's like certain 

21 wines have too much of it. Is it a byproduct from 

22 the pressing process, do you know?
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1 MEMBER SWAFFAR: -- that talked about 

2 like in California and that it was such a warm 

3 climate they needed it to control the pH.

4 VICE CHAIR CHAPMAN: I get its use in 

5 wine, I guess. If it's used in wine and then it's 

6 produced from wine. It's like an endless cycle.

7 MEMBER SWAFFAR: Regenerative. Yes.

8 MEMBER AUSTIN: Any other questions? 

9 Thank you, Ashley. 

10 Next we will discuss cellulose. Dr. 

11 Brines?

12 DR. BRINES: Thank you. Cellulose is 

13 included under Section 205.605 of the National List 

14 under paragraph B, Synthetics Allowed.

15 It reads as cellulose for use in 

16 regenerative casings as an anti-caking agent, 

17 non-chlorine bleached and filtering aid.

18 In support of the review this round the 

19 Handling Subcommittee did request the development 

20 of a third party technical evaluation report.

21 That report was completed and is 

22 available to the public and the Board members on 
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1 the National Organic Program website. Thank you.

2 MEMBER AUSTIN: Thank you. I'm the 

3 lead on this one.

4 Cellulose in its natural form is the 

5 main structural component of higher plant cell 

6 walls, one of the most abundant organic substances 

7 on Earth.

8 Most commercially available cellulose 

9 for the powdered form is produced from wood pulp 

10 and other plant sources.

11 The original process for making 

12 regenerated cellulose is called viscose method, 

13 converts cellulose fibers into regenerated fibers 

14 and films, and with some minor changes this process 

15 is still primarily in use today.

16 And I would point out that that was a 

17 process that was invented in the eighteen nineties.

18 For this first posting for cellulose 

19 there are currently two specific types of cellulose 

20 permitted in organic handling and processing. 

21 There's powdered cellulose and inedible cellulose 

22 casing.
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1 The uses are as follows. They're used 

2 as a processing aid for filtering juices and wines, 

3 also as an anti-caking agent for use in shredded 

4 cheese and other cheese products, also a processing 

5 aid in the inedible peelable hot dog and sausage 

6 casings.

7 Cellulose has been allowed for use in 

8 organic handling even prior to the creation of 

9 OFPA.

10 Some certifiers allowed it in use in 

11 cheeses since 1994, for some organic meats since 

12 1999. It's been allowed by several certifying 

13 bodies for international uses in organic handling 

14 as well.

15 As I said, there are numerous uses for 

16 cellulose in food handling, but not all uses are 

17 allowed in organic food production and handling.

18 This is a material that was in use by 

19 organic handlers even before the formation of the 

20 organic program and the creation of the National 

21 List.

22 We did receive a TR for this material, 
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1 and in that TR and along with written comments 

2 provided it did answer one of our questions about 

3 one of the ancillary materials and substances that 

4 could be found in cellulose.

5 Some of these are resin, glycerin, 

6 propylene glycol used in the sausage and cured 

7 meats, and dextrose enzymes used in cheese 

8 production.

9 It also mentions that mineral oil can 

10 sometimes be used as well as another commenter 

11 mentioned that polysorbate-80 could also be found 

12 as an ancillary material.

13 The TR does go on to mention that there 

14 are well defined sources of commercially available 

15 cellulose that do not include these ancillary 

16 substances.

17 A couple of environmental concerns that 

18 have been raised in the TR that we received on 

19 February 11 as well as in public comment.

20 One of those concerns, and this is a 

21 concern that have been raised in the past, are 

22 associated with the source which is from the 
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1 logging of trees for wood from which cellulose is 

2 derived.

3 The TR further mentions that some 

4 ecosystems have been replaced with fast-growing 

5 species of wood pulp trees.

6 Recycling and the use of alternative 

7 crops will help mitigate some of the impact of this.

8 An additional concern raised was about 

9 cellulose waste generated from food processing. 

10 These concerns could be mitigated with 

11 current research that is looking at conversion of 

12 this waste into useful products as mentioned in the 

13 TR under Daws and Singh 2004.

14 Also, recycling and the use of 

15 alternative crops will help mitigate the impact of 

16 cellulose manufacturing on biodiversity according 

17 to this document attached in the TR from Roberts 

18 2007.

19 The Select Committee on GRAS Substances 

20 released a report SCOGS 2015 that states, "There 

21 is no evidence in the information currently 

22 available today that demonstrates or suggests any 
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1 hazards to the public at the levels that are 

2 currently used or might reasonably be used in the 

3 future."

4 Historic discussion. During the 

5 October 16, 2001 NOSB fall meeting the original 

6 discussion around listing of cellulose for use in 

7 organic handling first took place.

8 It was determined then that there were 

9 two sources of cellulose approved for use in 

10 organic food processing and handling. That would 

11 be regenerative casings and powdered cellulose 

12 used for anti-caking and as a filtering aid.

13 Part of that discussion during that 

14 time was considered around whether or not the word 

15 "powdered" should be added. This was one of the 

16 questions that we sent in our proposal out for 

17 comments back.

18 It was ultimately decided at that point 

19 not to add that more restrictive word.

20 During the last sunset cycle in 2012 the 

21 word "powdered" was part of an annotation. When 

22 the NOP did the 2013 sunset docket they were not 
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1 able to make that change to the annotation due to 

2 the lack of time needed to add the changes, inform 

3 the public, and the need to determine and estimate 

4 the impact that this more restrictive annotation 

5 might have due to lack of time needed to add the 

6 changes and inform the public, and need to 

7 determine and estimate the impact.

8 So it still exists today as it was 

9 previously listed. So it still remains unclear at 

10 this time if the word "powdered" should be added, 

11 or if it should not be added as a means to limit 

12 the types of cellulose for particular uses that 

13 should be included on the National List by the NOSB.

14 It's also not clear if there's any 

15 further actions that we the NOSB or the Handling 

16 Subcommittee should take based off of that previous 

17 recommendation.

18 I think we would like to see some 

19 feedback from the program on that as we move forward 

20 to this next semester of work on this material.

21 I would also like to mention that also 

22 at the spring 2012 meeting the certifiers and 
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1 handlers provided information to confirm that 

2 microcrystalline form of cellulose was not used in 

3 organic handling.

4 This is a question that has come up, 

5 continues to come up in public comments. And that 

6 is part of the reason why and the rational why they 

7 wanted the word "powdered" added to the annotation, 

8 to be a little bit more restrictive on what 

9 materials actually could be -- the forms of 

10 cellulose actually could be allowed.

11 Written public comment provided us all 

12 kinds of answers to that across the board. We have 

13 those supportive. We have those that were not 

14 supportive. We've got those that really didn't 

15 know if it would make a big deal if we added it or 

16 we didn't have it on there. 

17 So, I don't think we gained any traction 

18 on clarification on that. I think we've had just 

19 as many answers back from comments to not add 

20 "powdered" as we had to add "powdered" and some that 

21 just weren't certain on what that impact would 

22 possibly have to the annotation if we were to do 
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1 that.

2 We did get back roughly 18 written 

3 comments, 2 oral comments via the webinar, and 4 

4 during our in-person testimony over the last couple 

5 of days.

6 There were several industry and 

7 certifier surveys that showed material was still 

8 much used and listed as critically important.

9 One public interest group, while taking 

10 a neutral position would support the annotation to 

11 read "Amorphous powdered cellulose and inedible 

12 cellulose casings" then they would support it if 

13 we changed the annotation to read that, while 

14 another was opposed, stating that alternatives do 

15 exist.

16 And we've heard from others in support 

17 of the material that there are no alternatives, 

18 especially for the casings that exist other than 

19 some form of plastic.

20 Those who supported also said that it 

21 is still critical in their cheese processing. And 

22 as I just stated, skinless hot dogs and sausages. 
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1 It's also used in wine and juice production as an 

2 anti-caking agent.

3 And previous reviews have found no 

4 substantial risk to the environment, human health, 

5 or animal health from its manufacture or uses.

6 We did get answers to our ancillary 

7 questions. And I want to say at this point that 

8 I do appreciate the number of comments, both in 

9 favor and those that were questioning whether or 

10 not we needed annotations on this.

11 Thank you. I'll open it up for any 

12 questions from the Board at this time. Emily.

13 MEMBER OAKLEY: So, are you guys still 

14 unclear as to whether or not you want to add the 

15 annotation that you had in 2012? Or you're seeking 

16 more information?

17 MEMBER AUSTIN: Two points I'll make is 

18 that the subcommittee -- one point I should have 

19 made to begin with. 

20 The subcommittee was pretty much in 

21 favor of the continued listing of this material. 

22 As far as the annotation, that's why I 
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1 read it into the public record right now because 

2 I think we -- there's an annotation that was 

3 already, and a motion that was already moved 

4 forward back in 2012 that was not able to be acted 

5 upon.

6 And I would like for the National 

7 Organic Program to give us feedback on whether they 

8 can still act upon that, or if they still need 

9 further continuation and another action from our 

10 subcommittee and this Board to move that forward.

11 So it's still unclear. So we need a 

12 little bit of clarity and direction provided back 

13 to us from the program on that. Based off of the 

14 2012 motion that was passed by the Board.

15 Jean.

16 MEMBER RICHARDSON: Yes, a couple of 

17 questions, Harold. On the regenerative casings 

18 they're normally not eaten, is that correct?

19 MEMBER AUSTIN: Correct. Those are 

20 generally peelable.

21 MEMBER RICHARDSON: Because the 

22 alternatives are the animal intestines that we 
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1 passed at the last Board meeting? Okay.

2 On the anti-caking agents, for example, 

3 in like parmesan cheese for example. So I buy a 

4 container of organic parmesan cheese that's 

5 already grated up. Will that have the cellulose 

6 on the label?

7 MEMBER AUSTIN: Yes, it should. Yes. 

8 The substance should be on that label for that 

9 specific use.

10 MEMBER RICHARDSON: So it will be on 

11 the label. So people again have a choice to avoid 

12 it if they don't want it.

13 MEMBER AUSTIN: Correct.

14 MEMBER RICHARDSON: Because the 

15 average consumer is not going to like to think 

16 they're eating wood or recycled cardboard.

17 MEMBER AUSTIN: Yes.

18 MEMBER RICHARDSON: I mean, I sit in 

19 the consumer seat so I'm trying to think of how we 

20 would feel looking at the cellulose.

21 MEMBER AUSTIN: Well, and I think if we 

22 look, I mean like I said on the casing material. 
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1 You know, it's processed and a material that's been 

2 used since 1890. So it's not like this is 

3 something that's brand new and hasn't been around 

4 and just popped up overnight.

5 So I think probably all of us have been 

6 eating it in one way, shape, or form for a lot longer 

7 than we want to think about. Francis?

8 MEMBER THICKE: Jean, there was an 

9 episode on Dr. Oz in which he made a big deal about 

10 looking.

11 And I looked at the cheese labels and 

12 sure enough, there it is. I think he mentioned it 

13 was in organic too.

14 MEMBER RICHARDSON: Dr. Oz. Now we 

15 know what he listens to.

16 MEMBER AUSTIN: Tom?

17 VICE CHAIR CHAPMAN: I'm not a 

18 particular fan of pre-shredded cheese myself. 

19 That's why I buy a block and shred it myself.

20 But I would equally say do your 

21 consumers want pre-shredded cheese. Is this the 

22 cost that it comes with.
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1 MEMBER AUSTIN: And the comments that 

2 we did receive back says that they have looked at 

3 other ways to try to formulate that. And without 

4 the cellulose there would be no shredded cheese.

5 Any other comments? Questions? 

6 Harriet.

7 MEMBER BEHAR: Way back when I worked 

8 for Organic Valley. I left there in 1996, but I 

9 helped put this product on the National List when 

10 I worked there. And I am part of that annotation 

11 of non-chlorine bleached was because the chlorine 

12 bleached cellulose does carry the risk of dioxin 

13 production.

14 And I know that it has been very useful 

15 for shredded cheese.

16 And when I did talk to many scientists 

17 at that time I remember someone said to me a lot 

18 of people chew on toothpicks, so there isn't always 

19 an aversion to having wood in your diet.

20 MEMBER AUSTIN: Thank you. Any 

21 further questions? Tracy.

22 CHAIR FAVRE: Harold, I think Dr. 
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1 Brines had a request to clarify some of the language 

2 on the annotation.

3 MEMBER AUSTIN: Dr. Brines.

4 DR. BRINES: Thank you. Yes, in 

5 response to the question about the status about the 

6 past NOSB recommendation to change the annotation 

7 on the substance that recommendation is under 

8 consideration by the National Organic Program. 

9 And the plan is for us to include it in a future 

10 proposed rule on the National List which is 

11 currently in development.

12 So, for the purpose of this sunset 

13 review the Board does need to look at the current 

14 listing of the material. But I just wanted to keep 

15 the Board informed that that old recommendation is 

16 still under consideration. Thank you.

17 MEMBER AUSTIN: Thank you for that 

18 clarification. Any additional questions? All 

19 right, we'll continue to move forward.

20 Next will be potassium hydroxide. Dr. 

21 Brines?

22 DR. BRINES: Thank you. This
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1 substance is also included under Section 205.605 

2 of the National List under paragraph B for 

3 Synthetics Allowed.

4 The listing reads as potassium 

5 hydroxide prohibited for use in lye peeling of 

6 fruits and vegetables except when used for peeling 

7 peaches.

8 In support of the review the Handling 

9 Subcommittee did request the development of an 

10 updated technical evaluation report. That report 

11 was completed and is available to the public and 

12 Board members on the National Organic Program 

13 website. Thank you.

14 MEMBER AUSTIN: Thank you. Ashley?

15 MEMBER SWAFFAR: So, potassium 

16 hydroxide is a synthetic inorganic compound 

17 produced by the electrolysis of potassium 

18 chloride, also known as potash.

19 It is a strong base in alkaline in 

20 solution and it has many uses including as a 

21 cleaning agent, pH adjustment, stabilizer and the 

22 peeling of peaches.
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1 We had a limited number of commenters 

2 on this substance, but we did hear that it is used 

3 as a processing aid in buttermilk.

4 And several certifiers written in and 

5 stated -- only those who wrote in -- approximately 

6 70 of their operations have potassium hydroxide 

7 listed on their organic system plan.

8 And we also did hear from some members 

9 of the community stating their concern on potassium 

10 hydroxide's hazards with several good questions 

11 raised in those comments. And we will be looking 

12 into those in committee.

13 MEMBER AUSTIN: Thank you. Any 

14 questions from the Board? Zea.

15 MEMBER SONNABEND: Well, this is not a 

16 question but a comment.

17 Historically this is one of the very 

18 most controversial materials that ever got added 

19 to the list. And a few commenters were not around 

20 -- well, most people weren't around. Me and a few 

21 of us.

22 But there are NOSB meetings in the past 
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1 where we heard extensive, extensive public 

2 comments about its use in peaches in particular.

3 But this time we got some of the public 

4 commenters who hadn't gone back to the record and 

5 said well, we haven't really heard from anyone 

6 about the necessity of this material and we think 

7 you should do a full investigation.

8 So, I would just suggest that anyone 

9 with concerns go back and look at the old records. 

10 I hope most of it is captured. I know one meeting 

11 in particular we had dozens of commenters about 

12 this. And it is there in the past historic record.

13 MEMBER AUSTIN: Thanks, Zea. Jean, 

14 you had a question?

15 MEMBER RICHARDSON: Yes, my question 

16 was somewhat similar to Zea's comment so I'm not 

17 sure whether I really need to go there.

18 But how do you think we are trending in 

19 our discussion on the Handling Committee on this? 

20 To me it doesn't seem terribly necessary.

21 MEMBER AUSTIN: Zea, go ahead.

22 MEMBER SONNABEND: It's absolutely 100 
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1 percent necessary for canned peaches. 

2 Now, whether you think canned peaches 

3 is an essential part of the diet or not. And it's 

4 also used in IQF. 

5 It was first put on only for canned 

6 peaches. And it would have killed anyone growing 

7 clingstone peaches which are primarily used for 

8 canning throughout the country if it was not 

9 allowed.

10 But then of course much more people eat 

11 frozen peaches and so it was added IQF as an 

12 additional use for it because while hot water is 

13 the alternative, but on the scale that they make 

14 frozen or canned peaches hot water is just not 

15 realistic.

16 We had among the testimony is one 

17 gentleman who has since passed on, but who was a 

18 cling peach grower and had done hot water 

19 experiments on his peaches. And they just came out 

20 so unbelievably mushy that it just wouldn't be 

21 acceptable to consumers.

22 And so that's what led to it being put 
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1 on the list, for those particular uses.

2 The other uses I cannot really comment 

3 on.

4 MEMBER AUSTIN: Emily.

5 MEMBER OAKLEY: I just want to clarify 

6 that, Zea, you had that almost right. It was just 

7 the original listing and the petition was for the 

8 IQF peaches only. And then just a couple of years 

9 ago we amended it to drop which format of processing 

10 peaches. But basically for all processing.

11 And I'd also like to add that we 

12 recently located the original 2001 petition and we 

13 scanned it all. And there's a ton of the original 

14 data from all those peach-peeling experiments, et 

15 cetera, on the National List substance database.

16 MEMBER AUSTIN: Thank you. Tom?

17 VICE CHAIR CHAPMAN: Let's go to Jean's 

18 follow-up and then me.

19 MEMBER AUSTIN: Okay, Jean.

20 MEMBER RICHARDSON: Yes, quick 

21 follow-up. So, if it's so important why is it 

22 apparently not allowed in other parts of the world 
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1 for this purpose?

2 MEMBER SONNABEND: I don't know what 

3 the canned and frozen peach industry is like in 

4 other parts of the world for organic so I can't say.

5 MEMBER AUSTIN: Maybe somebody in the 

6 listening audience will be able to provide us with 

7 some written comments to that effect prior to our 

8 fall meeting. Tom.

9 VICE CHAIR CHAPMAN: So this is also 

10 used in the blackening of cocoa powder. So, if you 

11 want your Newman's O's or organic Oreos, potassium 

12 hydroxide.

13 MEMBER AUSTIN: Thank you. Ashley.

14 MEMBER SWAFFAR: Jean, is it allowed in 

15 other parts of the world, but not for the peeling 

16 of fruits and vegetables. Just the pH adjustment. 

17 MEMBER RICHARDSON: Right. No, I 

18 understand it's used for a pH adjustment, but it's 

19 not used for this purpose as far as I know in canned

20 peaches in Europe. 

21 For cocoa it definitely is. The Dutch 

22 process started.
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1 MEMBER AUSTIN: Any additional 

2 questions or comments? Seeing none we'll move on. 

3 Thank you, everybody.

4 Next will be silicon dioxide. Dr. 

5 Brines.

6 DR. BRINES: Thank you. This 

7 substance is included under Section 205.605 of the 

8 National List under paragraph B, Synthetics 

9 Allowed. 

10 Note one correction. On the meeting 

11 materials it's listed under paragraph A but it is 

12 paragraph B and it's correct elsewhere in the 

13 document.

14 The listing reads as follows. Silicon 

15 dioxide permitted as a defoamer, allowed for other 

16 uses when organic rice hulls are not commercially 

17 available. Thanks.

18 MEMBER AUSTIN: Thank you. Lisa?

19 MEMBER DE LIMA: So, silicon dioxide is 

20 used as an anti-caking agent, an absorbent, a 

21 defoaming agent, a filtration agent for beer.

22 It's manufactured by vapor phase 
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1 hydrolysis. It can be produced as a nanomaterial 

2 but for organics the material would have to be 

3 petitioned to be placed on the National List.

4 We requested that the public give us a 

5 better understanding of where rice hulls weren't 

6 a viable alternative and why.

7 And feedback included that rice hulls 

8 don't work in powdered cheeses, dry flavors, fruit 

9 powders, rice syrup solids, as a flow agent for 

10 spice and seasoning blends, and we were also told 

11 that it's used to meter seed during the seed 

12 pelleting process.

13 Public comment was generally 

14 supportive of retaining on the National List.

15 We did have one comment from a retailer 

16 who was not supportive because silicon dioxide 

17 could be produced by nanotech. But I already 

18 addressed that as far as in organics it wouldn't 

19 be allowed.

20 One commenter wanted us to revisit the 

21 language of the annotation that the previous Board 

22 put forth in that that language was not exactly 
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1 adopted by the NOP.

2 And another organization just called 

3 for more research into alternatives for the 

4 anti-caking and filtration uses before the next 

5 sunset.

6 MEMBER AUSTIN: Thank you. Any 

7 questions for Lisa from the Board? Tom?

8 VICE CHAIR CHAPMAN: I just want to 

9 draw the attention to a public comment we got from 

10 PowderPure. It's a manufacturer of organic fruit 

11 and vegetable powders, other food powders.

12 They provided a video and their link to 

13 YouTube which is 20 minutes long with about 30 

14 seconds of content much like when I speak.

15 But it really shows how rice hulls and 

16 silicon dioxide, how effective they are in powders 

17 at different temperatures. I highly recommend 

18 watching that video to get a sense of how equivalent 

19 these products are, how effective rice hulls are 

20 comparative to silicon dioxide.

21 And if you don't want to watch the 

22 video, silicon dioxide was clearly the better flow 
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1 agent where at like about 100 degrees Celsius all 

2 the powders would block up with the rice hulls.

3 MEMBER AUSTIN: Jean.

4 MEMBER RICHARDSON: A question for the 

5 lead person.

6 As a consumer do I have to be worried 

7 about the human health impacts of the silicon 

8 dioxide from the research that you did as you 

9 developed this initial work?

10 MEMBER DE LIMA: I'm going to say no. 

11 I mean, nothing new came up when we were doing the 

12 review in subcommittee indicating so.

13 MEMBER AUSTIN: I would probably point 

14 out that this is material that has been on the 

15 National List that has been reviewed for human 

16 health and environmental concerns in the past prior 

17 to our current sunset review.

18 And I don't think there was anything 

19 significantly that has been brought before our 

20 subcommittee at this point that would tell us 

21 negative or otherwise to the contrary of what's 

22 been seen in previous reviews.
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1 Lisa?

2 MEMBER DE LIMA: I will say, Jean, that 

3 we've had some consumer question, but it's 

4 specifically because they hear that silicon 

5 dioxide can be produced via nanotechnology.

6 So when I get consumer questions it's 

7 specific to the nanotech.

8 MEMBER AUSTIN: Any additional 

9 comments or questions? 

10 Seeing none we'll continue to move onto 

11 our final sunset 2018 material which was colors, 

12 beta-carotene extract. Dr. Brines?

13 DR. BRINES: Thank you. This 

14 substance is included under Section 205.606 of the 

15 National List, Non-Organically Produced 

16 Agricultural Products Allowed as Ingredients in or 

17 on Processed Products Labeled as Organic.

18 It appears under paragraph D, colors 

19 derived from agricultural products must not be 

20 produced using synthetic solvents and carrier 

21 systems, or any artificial preservative.

22 The listing reads under 2, 
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1 beta-carotene extract, color derived from carrots 

2 or algae, pigment CAS No. 7235-40-7. Thank you.

3 MEMBER AUSTIN: Thank you. Jean, if 

4 you would give the subcommittee's presentation for 

5 the full Board, please.

6 MEMBER RICHARDSON: Yes. You'll 

7 recall we did a lot of the colors at our last sunset 

8 meeting and this one has a different sunset date.

9 So, in looking at the beta-carotene as 

10 used for color, in other words it's obviously going 

11 to be -- its primary purpose is color. It's not 

12 as a vitamin A source.

13 We posed several questions for this 

14 material because originally it tended to be used 

15 from carrots, and of course they were non-organic 

16 carrots because of the lack initially of there 

17 being a lot of organic carrots available even 

18 though today you'd think that there would be a lot 

19 of carrots available.

20 However, the research from the users of 

21 the beta-carotene color indicate that the carrot 

22 color doesn't give them the depth or intensity of 
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1 color, or the stability, and so the trend over time 

2 has actually been for as far as I can tell from the 

3 works that I've looked at including the technical 

4 report is that nowadays most of the beta-carotene 

5 for color comes from algae.

6 And of course this will also be one of 

7 the materials that we'll be looking at this summer 

8 as we look at all of the various seaweed plant 

9 materials that are being used.

10 I did ask some questions on which 

11 species of algae are used and from where are they 

12 harvested. There is some of this information in 

13 the TR. 

14 But I didn't get any additional 

15 response on that from the posting from the general

16 public, and didn't therefore get any information 

17 that would allow me to understand whether or not 

18 these harvested seaweeds in the red algae group are 

19 able to be then wild crafted.

20 Some of the species like the genus 

21 Dunaliella is being cultivated. And one would 

22 imagine that this could in fact be a certified 
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1 product since it's not in an ocean system, but 

2 they're in kind of big lakes and things, especially 

3 in Australia.

4 So, it would be great if we could have 

5 people out there that are using it to get us some 

6 more information as to what their sources are for 

7 the material that they're using from industry. 

8 That would be helpful for us as we deliberate this 

9 this summer.

10 What we got in public comment is some 

11 of the, let's see, we have two certifiers. We 

12 didn't get a lot of public comment. 

13 Two of the certifiers simply listed 

14 those producers that used it. Not extensive, but 

15 there was a number from one of them in particular.

16 One certifier indicated that they 

17 didn't have any of their clients using it.

18 We had two manufacturers who obviously 

19 would like to see it continue to remain on the list, 

20 especially because of the need to have a deeper 

21 stability and a depth of color.

22 Three consumer groups would recommend 
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1 that it is not essential and that there are organic 

2 sources. Although they again were talking 

3 particularly about carrots, and it's my 

4 understanding that most of it is as I say coming 

5 nowadays from a culture system of Dunaliella, two 

6 different species of it that are produced in high 

7 salt, nitrate-rich medium.

8 So, I wish that we'd got more 

9 information back from the public on this as to 

10 whether or not it's really available organically, 

11 or could be potentially organically obtained from 

12 either carrots, organic carrots, or from the 

13 seaweeds.

14 So, it's a mixed bag of response that 

15 we got for that. So we will have to deliberate 

16 whether or not this is really essential or not when 

17 we get into our discussions this summer.

18 MEMBER AUSTIN: Thank you, Jean. Any 

19 comments or questions from the Board or the 

20 subcommittee? Lisa?

21 MEMBER DE LIMA: So, to the first 

22 question that was put out to the public about 
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1 extraction methods, we didn't get anything back? 

2 No.

3 MEMBER AUSTIN: Harriet.

4 MEMBER BEHAR: In what type of foods is 

5 this color typically used?

6 MEMBER RICHARDSON: Types of foods. I 

7 don't have a perfect answer to that, sorry. But 

8 I'll look into it for you.

9 MEMBER AUSTIN: Ashley.

10 MEMBER SWAFFAR: Harriet, one 

11 commenter stated they use it in like crackers and 

12 snack foods and stuff like that.

13 MEMBER AUSTIN: Tom.

14 VICE CHAIR CHAPMAN: I don't know, but 

15 we did get a commenter asking I believe about, you 

16 know, can annatto be used in its place, or can other 

17 yellow colors already -- like turmeric and the 

18 other yellow colors are on there.

19 I'd be curious to know the applications 

20 that require beta-carotene versus the other 

21 yellows that are there.

22 MEMBER RICHARDSON: I was doing all the 
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1 color, or at least a large number of them last fall 

2 when we were looking at the wide range of them.

3 And as I recall what they like about the 

4 beta-carotene is the strength of its color. So 

5 that they can have it -- it's concentrated. And 

6 so therefore they get more stability and a greater 

7 depth of color compared with the use of the other 

8 colors that may in that group provide a degree of 

9 that color.

10 MEMBER AUSTIN: Harriet.

11 MEMBER BEHAR: Are there ancillary 

12 substances with it?

13 MEMBER RICHARDSON: Not that I'm aware 

14 of.

15 MEMBER AUSTIN: Any further questions 

16 or comments? All right. Thank you, Jean.

17 All right, well that concludes the 

18 Handling Subcommittee's presentation to the Board 

19 and those present for our 2018 sunset materials 

20 under the first meeting review.

21 Madam Chair, we're ready to move on into 

22 our proposals.
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1 CHAIR FAVRE: Question for the Board. 

2 We're scheduled to have a break at 10:30. It's 

3 10:25 now. Would we prefer to take a break now, 

4 come back and do the proposal materials since we'll 

5 have a vote on those? Yes? 

6 Okay, folks, we're going to go ahead and 

7 take a 15-minute break now. So I'd like everybody 

8 back here at 10:40. Thank you.

9 (Whereupon, the above-entitled matter 

10 went off the record at 10:26 a.m. and resumed at 

11 10:42 a.m.)

12 CHAIR FAVRE: Thanks, everyone. I 

13 want to go ahead and continue with Handling 

14 Subcommittee. Harold?

15 MEMBER AUSTIN: Thank you, Tracy. 

16 Okay, the Handling Subcommittee has five proposals 

17 that we'll be moving into and discussing next.

18 The first material that we will be 

19 talking about, actually two materials, will be 

20 sodium and potassium lactate. With that I'll turn 

21 it over to Dr. Brines, please.

22 DR. BRINES: Thank you. Yes, this 
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1 includes both sodium and potassium lactate. And 

2 it was put onto the NOSB's agenda as a result of 

3 a petition submitted on January 5, 2004, from 

4 Applegate Farms.

5 It was not initially voted on at that 

6 time, but was added back onto the work agenda as 

7 a memo from the National Organic Program to the 

8 National Organic Standards Board. The memo is 

9 dated June 25, 2014, and contains additional 

10 background on the issue.

11 The petition requests the addition of 

12 these two lactate salts to Section 205.605 of the 

13 National List for use in meat processing.

14 In support of the review a technical 

15 evaluation report was completed in 2015. The 

16 scope of that report included lactic acid which was 

17 up for sunset review at the time as well as sodium 

18 lactate and potassium lactate in anticipation of 

19 the review by the Handling Subcommittee.

20 These two petitions were also on the 

21 agenda of the October 2015 NOSB meeting. The 

22 previous proposal from the 2015 meeting is posted 
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1 on the website as well as the petition, the 

2 technical report, the NOP memo to the Board and the 

3 meeting materials for this meeting. Thank you.

4 MEMBER AUSTIN: Thank you, Dr. Brines. 

5 Okay, so we have before us a proposal 

6 to add these two substances to the National List. 

7 We did, as Lisa said, we referred them back to the 

8 Handling Subcommittee at the fall 2015 NOSB meeting 

9 in Stowe.

10 The reason for doing so was to provide 

11 the subcommittee and the full Board with an 

12 opportunity to take and look at other ways that 

13 these two materials might currently be used in 

14 handling compared to how they were originally 

15 petitioned.

16 Both materials were originally 

17 petitioned for use in meat processing as pathogen 

18 inhibitor that is used to help control Listeria in 

19 ready-to-eat meat and poultry products.

20 Both materials have been allowed for 

21 use in organic handling since January 22, 2004, 

22 when they were petitioned at that time.
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1 They were originally allowed for use 

2 and that petition was sent back to the petitioner 

3 with no action required by the NOP based on the fact 

4 that at that time the belief was that at that time 

5 the three materials used to formulate either 

6 material were actually on the National List. And 

7 those materials were sodium hydroxide, potassium 

8 hydroxide, and lactic acid.

9 That decision as outlined in our 

10 proposal caused considerable confusion with the 

11 certifiers and with the handlers themselves, and 

12 that's why we're here again today, to discuss 

13 whether or not we should add these materials to the 

14 National List at 205.605(b) Synthetics Allowed.

15 Some of the additional uses in organic 

16 handling included but not limited to are used in 

17 organic meat flavoring such as chicken flavor, beef 

18 flavor, use in organic processed meats, sausages, 

19 meatballs, other similar types of production, and 

20 also by an internationally certified organic 

21 handler in the manufacturing of their organic herb 

22 and spice paste both to provide an antimicrobial 
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1 control, but also as a pH regulator.

2 According to the February 17, 2015, TR 

3 it does not appear that either material have any 

4 human health concerns associated with them.

5 The same report does note that both 

6 materials are considered GRAS by the FDA.

7 The same report also states that there 

8 are no additional ingredients or ancillary 

9 substances, stabilizers, preservatives, carriers, 

10 anti-caking agents, et cetera, added to 

11 commercially available forms of either of these two 

12 materials when used in organic handling and 

13 processing.

14 While the original petition's use was 

15 intended for use in the meat processing as a 

16 pathogen inhibitor in the ready-to-eat meat and 

17 poultry, since then and as we've looked and 

18 discovered this material has been allowed for other 

19 uses by organic stakeholders, by their certifiers 

20 as we've identified via the public comment process, 

21 some of these uses under the scope of this petition 

22 material review.
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1 Our findings show that sodium lactate 

2 and potassium lactate along with the original 

3 intended uses are also used in herbs, spice 

4 industry as I previously mentioned.

5 There have not been any environmental 

6 health -- human or animal health concerns that have 

7 been raised during this petition re-review 

8 process.

9 We have received considerable written 

10 and oral comments both last fall and then again this 

11 spring.

12 Several comments on this material at 

13 the fall meeting and the webinar. We got roughly 

14 20 written comments back this round, 1 oral comment 

15 via the webinar. Plus additionally we got six 

16 during the in-person time, four in support of, two 

17 opposed to.

18 Those opposing the listing are a couple 

19 of public interest groups. There are a couple of 

20 individual commenters stated that it was not 

21 essential, that alternatives do exist, primarily 

22 used as a preservative and therefore should not be 
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1 allowed.

2 One commenter raised a concern about 

3 the feedstock source that is fermented to make the 

4 lactate that might be made from conventional GMO 

5 sources.

6 Those supporting the listing stated 

7 that the high-pressure processing could be a 

8 possible alternative, but the technology is 

9 extremely expensive and therefore something that 

10 would not be available to all handlers to use at 

11 their expense because the cost would be 

12 prohibitive.

13 They are, especially the sodium 

14 lactate, the antimicrobial of choice in organic 

15 foods, especially in the meats, the herbs and the 

16 spices.

17 Sodium lactate is permitted in the EU 

18 in milk-based and meat products. Lactic acid is 

19 not a suitable alternative where the pH must be 

20 raised.

21 Alternatives damage natural flavor, 

22 color and aroma -- this is referring to the spices 
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1 and the herbs -- and also numerous organic herb and 

2 spice growers commented on that.

3 Alternatives listed either are not 

4 effective under specific conditions such as lactic 

5 acid or have negative impact on the flavor or taste 

6 such as the impact caused by the fruit powders and 

7 those of the essential oils.

8 One commenter raised a concern that 

9 discussion around these two materials fails to 

10 address the other salt of lactic acid material, 

11 calcium lactate.

12 In discussion with the program we 

13 determined that the TR specifically addressed 

14 lactic acid, sodium and potassium lactate. Thus, 

15 calcium lactate falls outside of the scope of this 

16 review at this time as well as the petition, the 

17 original petition was to list both sodium and 

18 potassium lactate and did not include calcium 

19 lactate within it.

20 So, I would state right now at this 

21 point that if somebody has some concerns with 

22 calcium lactate in that it's fallen outside of the 
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1 review that we're currently undertaking that we 

2 probably might want to see something done on that, 

3 maybe a petition for us to review that possibly.

4 It would appear based off of the earlier 

5 discussions and decisions that there are organic 

6 handlers, and we know via public comment, that are 

7 currently using these materials, especially the 

8 sodium lactate.

9 This time via public comment we did not 

10 receive any specific comments back in favor of 

11 using or in support of continuing to use potassium 

12 lactate.

13 We did receive two specific comments 

14 back last fall, however. And so I want to take and 

15 use those as a continuation that we do have comments 

16 that were in support of potassium.

17 Typically what we have seen is those 

18 that are commenting either in support of or 

19 commenting against have lumped the two lactic, 

20 potassium and sodium together. So, they're looked 

21 at as similar, as the same.

22 The preference from the handlers are if 
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1 they're using a sodium-based or something --

2 they're using the sodium lactate, if they're using 

3 a low sodium process then they're opting to use the 

4 potassium lactate as a lower non-sodium 

5 formulation in their processing.

6 With that I will open it up for 

7 discussions from the Board. Jean?

8 MEMBER RICHARDSON: In my experience 

9 going around doing slaughterhouse inspections as 

10 an inspector because it's allowed under organic 

11 standards right now I find that -- or at least the 

12 sodium particularly is -- sodium lactate is used 

13 in order to inhibit the growth of Listeria, E. coli, 

14 Salmonella. And it's sprayed on the carcasses as 

15 they're hanging there in the cooler following 

16 slaughter.

17 Are you aware of any alternatives that 

18 could be used if we didn't continue to list this?

19 MEMBER AUSTIN: We had one comment last 

20 fall that said that in their particular operation 

21 for that specific use they did not have an 

22 alternative that they found that was suitable for 
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1 their specific operation. And I cannot remember 

2 who that commenter was, Jean.

3 Harriet?

4 MEMBER BEHAR: My understanding it is 

5 direct lactic acid, not the sodium lactate that is 

6 used to be sprayed on the carcasses. And that the 

7 sodium lactate is used in the final product as a 

8 pH and somewhat of a preservative.

9 So, are you sure you're seeing them 

10 spray sodium lactate, or just lactic acid?

11 MEMBER RICHARDSON: Both.

12 MEMBER AUSTIN: Yes, there was a 

13 specific comment last fall to that specific use for 

14 it. But I don't think that is the primary use for 

15 it. Emily.

16 MEMBER OAKLEY: So Harriet, is lactic 

17 acid sufficient on its own without the sodium 

18 lactate?

19 MEMBER RICHARDSON: I don't have a 

20 scientific answer for that, but I'll certainly look 

21 into it as we go into the next round of discussing 

22 it.
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1 MEMBER AUSTIN: Harriet, go ahead.

2 MEMBER BEHAR: My understanding is 

3 that FSIS does have lactic acid listed as one of 

4 the mitigation tools that can be used to prevent 

5 E. coli and other pathogen problems on raw meat. 

6 So there's hot water, there's lactic 

7 acid, and there's a few others. But lactic acid 

8 is seen as approved and effective. 

9 MEMBER AUSTIN: I think it depends on 

10 the listing and how the handler in the operation 

11 is using it for that specific use, particular use 

12 possibly.

13 But I know in the case of the herb and 

14 the spice producers lactic acid has been looked at 

15 and that is not an option that they can use 

16 sufficiently and effectively in their operation. 

17 Provided in the comments and the testimony that 

18 they provided with us yesterday.

19 Emily, follow-up?

20 MEMBER OAKLEY: Yes, I appreciate that 

21 for them they've tried other materials and haven't 

22 found anything.
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1 My main reservation is that as was 

2 stated in the proposal that meat products that 

3 contain sodium or potassium lactate can no longer 

4 be labeled as natural without a case-by-case basis 

5 assessment.

6 And it seems a little bit challenging 

7 to consider this for organic production if it's 

8 questionable in natural production.

9 Can you talk to that?

10 MEMBER AUSTIN: I think in that 

11 particular concern in that listing that was raised 

12 on that particular statement that you just read, 

13 those materials, those products have to be looked 

14 at for the specific use on an as-use basis.

15 Because there's so many different ways 

16 that sodium and potassium lactate can be looked at 

17 as far as their uses, their intended uses and the 

18 properties that it's a case-by-case scenario that 

19 they will look at that to determine how 

20 specifically in that formulation that material is 

21 being used and looked at on a case-by-case basis 

22 is what that said.
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1 Jean, then Tom.

2 MEMBER RICHARDSON: In your research 

3 as you were putting this together, because I don't 

4 remember it coming much on our discussions on the 

5 subcommittee, did you find any specific scientific 

6 references to any human health impacts? I know 

7 it's GRAS, but apart from that was there any 

8 indication that there were negative human health 

9 impacts?

10 MEMBER AUSTIN: Jean, no. There was 

11 nothing new that was significantly brought 

12 forward.

13 The one concern was in the formation of 

14 lactic acid, the sheer amount of gypsum that was 

15 produced. There was significant references to 

16 solutions to utilizing that, moving it back into 

17 other uses, back into soil amendments. 

18 And that was well documented in that TR. 

19 Tom?

20 VICE CHAIR CHAPMAN: So, the spray use 

21 on carcasses is one, but it's also used in meat 

22 products itself. And it's used oftentimes to 
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1 replace sodium nitrate which is not allowed in 

2 organic production here. It is allowed in Europe 

3 for meat products for organic production. 

4 So I think that's a big difference to 

5 note here, that this is a less objectionable 

6 substance that we're using in place of a more 

7 objectionable substance for safety and for certain 

8 types of meat products that require this type of 

9 additive.

10 Now, when it comes to the objections of 

11 synthetic preservatives 205.600 speaks to that, 

12 but it's only applicable to processing aids and 

13 adjuvants. Would this be classified as a 

14 processing aid or an adjuvant?

15 MEMBER AUSTIN: No.

16 VICE CHAIR CHAPMAN: No. So then 

17 that's not applicable to this -- that criteria is 

18 not applicable to this substance.

19 MEMBER AUSTIN: Correct. Harriet, 

20 Francis, Jean.

21 MEMBER BEHAR: This is a tough 

22 substance for me and so I went on the internet and 
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1 looked around. And it is perceived as a 

2 preservative in the greater world. It is listed 

3 as a food preservative on many websites and the 

4 manufacturers sell it as a food preservative. 

5 Many of them label it as a natural preservative 

6 because it is better than potassium sorbate, or 

7 sorbic acid, or sodium nitrate. So those are the 

8 things that I saw.

9 And I also saw that typically it's used 

10 between 2 and 3 percent in the product. So that's 

11 a significant percentage that's used in the 

12 product.

13 I also was concerned about the natural 

14 label. And just when Lisa was talking about when 

15 she's bringing products to her store that she might 

16 be looking at what does that label look like.

17 And so I would feel terrible to see 

18 buyers looking at products and saying, well, this 

19 natural product, non-organic product doesn't 

20 contain sodium lactate, a preservative, right? 

21 They're looking on a website.

22 And see an organic product and say, 
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1 well, this has a preservative and that's not the 

2 one I'm going to bring into my store and have on 

3 my shelves.

4 So, I'm concerned somewhat about the 

5 clean label. And I'm not sure if an annotation we 

6 can somewhat work on it not being at the level of 

7 a preservative. And so that's where my concerns 

8 lie.

9 And I know that -- I did talk to Organic 

10 Valley and they are using high-pressure 

11 pasteurization to avoid the use of this product, 

12 although they say that they might like to have it 

13 in their back pocket for some future product. They 

14 don't know.

15 MEMBER AUSTIN: Francis.

16 MEMBER THICKE: I just want to remind 

17 us that we do have nitrate available through celery 

18 from last fall.

19 MEMBER AUSTIN: Thank you. Jean?

20 MEMBER RICHARDSON: Actually, my 

21 comments were somewhat similar to Harriet's. 

22 But I would like to point out that we 
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1 do have the annotation for use as an antimicrobial 

2 agent in the pH regulator only. So it's a 

3 challenge.

4 Because I know the perception is that 

5 it functions as a preservative, but did you see much 

6 of that when you were doing your research as the 

7 lead person into this material?

8 MEMBER AUSTIN: As far as, Jean?

9 MEMBER RICHARDSON: As far as it being 

10 used as a preservative as opposed to antimicrobial.

11 MEMBER AUSTIN: No, I don't think the 

12 intent of this material's usage by the handlers 

13 that are currently using it is as a preservative. 

14 It's really, truly as a pH adjuster or as an 

15 antimicrobial. 

16 Tom, Francis, Emily.

17 VICE CHAIR CHAPMAN: I wanted to talk 

18 to the natural comment and organics. It's a 

19 complex subject.

20 This is regulated. It's a meat product 

21 so it's under USDA which does have a "natural" 

22 definition.
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1 But on the processed food side it's 

2 pertinent while there isn't a definition for 

3 "natural" and it's kind of being litigated in the 

4 courts to de facto define "natural" the FDA says, 

5 "The Agency has not objected to the use of the term 

6 "natural" if the food does not contain an added 

7 color, artificial flavors, or synthetic 

8 substances."

9 There is a large list of synthetic 

10 substances, or I wouldn't say large, but a list of 

11 synthetic substances in handling products that's 

12 allowed on the list.

13 So you already have on the handling side 

14 a case where you could have an organic product that 

15 could not be labeled natural.

16 MEMBER AUSTIN: Thank you, Tom. I'm 

17 going to go with A-dae right now.

18 MEMBER ROMERO-BRIONES: So, Harriet, 

19 is high-pressure pasteurization available to 

20 larger producers, small producers, do you know? 

21 As a suitable alternative.

22 MEMBER BEHAR: I don't know the answer 
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1 to that question, but I know that we are a 

2 process-based standard. 

3 And I know that we did eventually get 

4 a lot of the boiler chemicals off the National List 

5 because over time we were able to approach the 

6 problems that the boiler chemicals were addressing 

7 through more of a process-based approach.

8 And so I don't know the answer to that 

9 question. But again, this is a process rather than 

10 an input that would deal with the pathogen issue.

11 And then also too, it only affects 

12 bacteria, not yeasts or molds. So it's not a full 

13 category antimicrobial.

14 MEMBER AUSTIN: A-dae, to answer part 

15 of your question, one of the comments back to us 

16 stated that the high-pressure processing could be 

17 a possible alternative, and it is currently being 

18 used, but that technology is extremely expensive 

19 and would be out of the limits of certain handlers 

20 and processors to be able to afford it.

21 MEMBER DE LIMA: So, since someone 

22 brought up clean labels and how that label is going 
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1 to look, from my perspective the organic meat 

2 market is so small. I mean, it's been hard. It's 

3 gotten over easier over the years as production has 

4 ramped up. But it's really hard to fill a meat 

5 case, even just like a 12- or 16-foot meat case with 

6 only organic meat. I mean, it's impossible, at 

7 least where we are geographically on the east coast 

8 for our stores.

9 So, I'm comfortable with it as long as 

10 it has this annotation as it's written with the for 

11 use as antimicrobial agent and pH regulator only. 

12 Like, that's something I can say to a customer. 

13 Like, I can tell them this isn't used as a 

14 preservative. This is used for antimicrobial. 

15 And I'd rather have that conversation 

16 and still have certified organic options on the 

17 shelf than taking it out and potentially putting 

18 products at a disadvantage, and then having more 

19 natural on the shelf versus organic.

20 MEMBER AUSTIN: Okay, a couple of more 

21 questions. Francis, Emily, and then Zea. And 

22 then we're going to probably try to wrap it up.
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1 MEMBER THICKE: I'm having trouble 

2 with this distinction between an antimicrobial and 

3 a preservative because what causes something to 

4 decay are microbes.

5 And so if we have an antimicrobial we 

6 have in essence I think a preservative.

7 MEMBER AUSTIN: Yes, I was hoping that 

8 Emily could take and share me some words of wisdom 

9 over here.

10 I think, Francis, that that is 

11 something that we all struggle with the definition 

12 between that. And maybe that's something that we 

13 might need to throw out to the Board that we need 

14 to look at as future agenda material. 

15 Tom's going to give us some clarity 

16 though.

17 VICE CHAIR CHAPMAN: Well no, I just 

18 wanted to point out another antimicrobial 

19 preservative is salt. 

20 While the regulation itself prevents --

21 you know, it's kind of exempt from the whole 

22 process. It's a wide category. It's a difficult 
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1 piece to come to terms with.

2 MEMBER AUSTIN: It is. And I don't 

3 know if within the scope of our Board that's 

4 something that we want to try to look at to the 

5 future and try to find more of a defined definition 

6 of what those represent. Go ahead.

7 MEMBER THICKE: I guess if you think 

8 about it, what causes something to decay? It's 

9 microbes. And so if you're preserving something 

10 you're preventing microbes from causing it to 

11 decay, really.

12 Unless you have light decomposition or 

13 thermal decomposition what else would it be but 

14 microbial decomposition?

15 MEMBER AUSTIN: I think the intended 

16 use here though is not for -- to provide 

17 long-lasting preservative effects to the end 

18 product. But it's -- they were very specific that 

19 they were trying to deal with Listeria and E. coli. 

20 And I think it was more from a human health 

21 perspective than it was as a preservative type of 

22 an approach to this. So, I think that's the 
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1 clarity for this debate right now on these two 

2 materials. Tom?

3 VICE CHAIR CHAPMAN: Microbiological 

4 decay is one issue. But you know, moisture, 

5 moisture migration, dryness. There's a bunch of 

6 other preservation actions that preservatives take 

7 in products.

8 But this -- antimicrobial is one of 

9 them, yes. But it's -- preservatives is 

10 definitely a wider term than just antimicrobial.

11 MEMBER THICKE: But if you take out the 

12 moisture you're preventing microbes from growing. 

13 And so you're basically making an environment 

14 unfavorable to microbial growth.

15 VICE CHAIR CHAPMAN: I believe there's 

16 some preservatives that retain moisture to keep a 

17 product moist over its shelf life so it's a 

18 palatable product, like in breads and things like 

19 that.

20 MEMBER THICKE: But they prevent the 

21 microbes from colonizing I think. Anyway.

22 MEMBER AUSTIN: Emily, Scott.
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1 MEMBER OAKLEY: So, to Harriet's point 

2 about the two to three person use within a product 

3 overall, is there an application rate or a 

4 percentage that decreases the use as a preservative 

5 and makes it more aligned with -- this is maybe way 

6 too technical for this conversation, but just the 

7 pH regulator and microbial effects, and not giving 

8 you so much the flavor enhancement of a 

9 preservative?

10 VICE CHAIR CHAPMAN: I do want to note 

11 the TR says it's actually a 1 to 4.8 percent usage 

12 rate according to that. So it's larger than what 

13 we've been tossing around.

14 MEMBER AUSTIN: And those rates are 

15 following the FDA standards. So it's outside of 

16 the scope of our control on that part of it. Scott.

17 MEMBER RICE: I just, from a 

18 certification perspective and seeing a lot of food 

19 safety regulations coming at our clients and the 

20 folks that we work with, seeing this as kind of a 

21 tool in the tool box whose primary function is one 

22 of food safety and not of preservation in my mind 
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1 I see it as a valuable tool. I support it.

2 MEMBER AUSTIN: Thank you. Zea, then 

3 Harriet, and then we'll try to wrap this up if we 

4 can so we can try to keep a little bit on schedule.

5 MEMBER SONNABEND: This is just a bit 

6 of a historical perspective. This is a true 

7 example of the NOP at the time usurping the 

8 authority of the NOSB when they just issued a ruling 

9 by letter that the combination of two things on the 

10 National List was acceptable.

11 However, so I'm really glad that we're 

12 actually having a chance to properly review it. 

13 However, it has created the precedent that these 

14 things are being used. And so in some senses this 

15 has the aspects of a sunset review as well as just 

16 a brand new thing coming on the list.

17 But I am compelled by Scott's 

18 statements about food safety and Lisa's about 

19 enabling enough tools so that we can see organic 

20 meat in the marketplace so that I am okay with 

21 voting for this according to the due process.

22 MEMBER AUSTIN: And I think this is a 
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1 really good example of why the National List 

2 actually exists today. Harriet, final.

3 MEMBER BEHAR: So, there's a few things 

4 too then.

5 I know that body care products are not 

6 under our scope, but it is used widely in body care 

7 products as well. And there are people out there 

8 labeling things organic.

9 Also too that our sunset system now is 

10 that once it's on it's going to be harder to take 

11 off.

12 And then lastly, I'm going to ask Emily 

13 if it's possible if a manufacturer wants to put in 

14 parentheses after sodium lactate on their label can 

15 they use that extra modifier that says "as an 

16 antimicrobial agent" or something like that just 

17 to provide the consumer with a little more 

18 information and help that label look a little bit 

19 more food safety friendly.

20 I know that there's some things that the 

21 manufacturer can say on the label and some things 

22 that they cannot. So I'm curious if that would be 
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1 allowed after sodium lactate.

2 MS. BROWN ROSEN: I'd have to check the 

3 FDA labeling regulations on that. That would be 

4 under their control. They may or may not approve 

5 of that. But I can get back to you on that. Maybe 

6 someone in the audience knows.

7 MEMBER AUSTIN: I would just like to 

8 make a comment to one of the comments that you made 

9 though, Harriet, about referencing the fact that 

10 with this current changes to sunset that materials 

11 are going to be harder to get off of the Board.

12 Actually, I think if you look at the 

13 tenure of those of us that will be sunsetting off 

14 of the Board in this coming January we've actually 

15 physically removed more materials since the change 

16 to sunset than we did prior to the change of sunset.

17 The process of sunset is to allow the 

18 materials to go under review, and when it's time 

19 and there's an adequate replacement or alternative 

20 then they'll come off.

21 But we've removed a lot under this 

22 current sunset regime. We really have. So, just 
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1 for some clarity.

2 Any further debate on this material? 

3 And I would remind everybody that this does come 

4 before us as a full motion with a second.

5 We're going to move into the 

6 classification motion at this point to move -- and 

7 it comes from the subcommittee as a classification 

8 motion to classify both sodium lactate and 

9 potassium lactate as a synthetic.

10 The motion was made by myself and 

11 seconded by Ashley. Is there any further 

12 discussion or debate?

13 Tracy, I'll turn it over to you.

14 CHAIR FAVRE: Okay, we're going to 

15 start the voting with Francis.

16 MEMBER THICKE: Yes.

17 MEMBER AUSTIN: Yes.

18 MEMBER BUIE: Yes.

19 MEMBER BECK: Yes.

20 MEMBER SWAFFAR: Yes.

21 MEMBER ROMERO-BRIONES: Yes.

22 MEMBER DE LIMA: Yes.
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1 VICE CHAIR CHAPMAN: Yes.

2 MEMBER SEITZ: Yes.

3 MEMBER RICHARDSON: Yes.

4 MEMBER BEHAR: Yes.

5 MEMBER SONNABEND: Yes.

6 MEMBER RICE: Yes.

7 MEMBER OAKLEY: Yes.

8 CHAIR FAVRE: The chair votes yes. 

9 MEMBER DE LIMA: Fifteen yes, zero no. 

10 The motion passes.

11 MEMBER AUSTIN: Now, for the listing 

12 motion. We'll move it forward as presented.

13 Okay, so the listing motion will be to 

14 list sodium lactate and potassium lactate at 

15 205.605(b) of the National List with the following 

16 annotations: for use as an antimicrobial agent and 

17 pH regulator only.

18 That motion was moved by myself, 

19 seconded by Tom. 

20 CHAIR FAVRE: Start the vote with 

21 Harold this time.

22 MEMBER AUSTIN: Yes.
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1 MEMBER BUIE: Yes.

2 MEMBER BECK: Yes.

3 MEMBER SWAFFAR: Yes.

4 MEMBER ROMERO-BRIONES: Yes.

5 MEMBER DE LIMA: Yes.

6 VICE CHAIR CHAPMAN: Yes.

7 MEMBER SEITZ: Yes.

8 MEMBER RICHARDSON: Yes.

9 MEMBER BEHAR: Abstain.

10 MEMBER SONNABEND: Yes.

11 MEMBER RICE: Yes.

12 MEMBER OAKLEY: Abstain.

13 MEMBER THICKE: No.

14 CHAIR FAVRE: The chair votes yes.

15 MEMBER DE LIMA: Two abstain, one no, 

16 and 12 yes. The motion passes.

17 MEMBER AUSTIN: Thank you for a hearty 

18 debate and discussion on the last two materials. 

19 We'll move onto our next proposed 

20 material which is oat beta-glucan. Dr. Brines 

21 first.

22 DR. BRINES: Thank you. This 
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1 substance was petitioned by Tate & Lyle on March 

2 30, 2015. It requests the addition of oat 

3 beta-glucan to Section 205.606 of the National 

4 List.

5 The petition was also updated 

6 subsequent to its initial submission and those 

7 petition addenda are also on the National Organic 

8 Program website.

9 No technical report was requested by 

10 the subcommittee to assist in its review and this 

11 is the first NOSB meeting where the petition 

12 material is under consideration. Thank you.

13 MEMBER AUSTIN: Thank you. Lisa.

14 MEMBER DE LIMA: So, oat beta-glucan is 

15 being petitioned by the manufacturer Tate & Lyle 

16 as a natural component of oats.

17 According to the petition the substance 

18 is isolated through a simple process of grinding, 

19 enzyme treatment, water extraction and drying. No 

20 synthetic chemical additions or solvents are used 

21 in the manufacturing process being petitioned.

22 The only additives used in producing it 
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1 are water and the enzymes.

2 Its benefit as put forward in the 

3 petition is that it's used to supplement the fiber 

4 content in processed foods including cakes, 

5 breads, cereals, bars, soups and smoothies.

6 Other names for oat beta-glucan include 

7 oat bran, soluble fiber, oat fiber and oat bran 

8 fiber.

9 Overall oat beta-glucan appears to have 

10 no significant negative impacts on human health.

11 The petition pointed out that oat 

12 beta-glucan is used in handling and not crop 

13 production and thereby concluded that it had no 

14 effect on soil, crops, or livestock.

15 But the Handling Subcommittee would 

16 like to point out that according to the USDA 

17 Pesticide Data Program there are seven pesticide 

18 residues found on conventionally grown oats.

19 The petition goes on to point out 

20 there's currently no source of organic oat 

21 beta-glucan despite organic oats and organic oat 

22 bran being widely available in the U.S. and Canada.
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1 The petition goes on to state that in 

2 Nordic countries where a large amount of oat 

3 beta-glucan is currently manufactured, that's 

4 non-organic oat beta-glucan, that organic and oats 

5 and organic oat bran quantities are limited.

6 Basically the subcommittee came to the 

7 decision, we didn't think there was any reason why 

8 oat beta-glucan could not be manufactured 

9 organically. And actually in the past there was 

10 one manufacturer that used to produce an oat 

11 beta-glucan and stopped doing so due to low demand.

12 So we found that the substance failed 

13 as far as essentiality and availability.

14 MEMBER AUSTIN: Thank you. Any 

15 questions from the Board? Tom.

16 VICE CHAIR CHAPMAN: I found the 

17 statement in the petition about a low availability 

18 of organic oats in Nordic countries peculiar in the 

19 fact that U.S. is currently importing organic oats 

20 from Nordic countries.

21 So, clearly available for export. I 

22 would think it would be clearly available to make 
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1 into a fiber product.

2 It seems like it's a demand issue in the 

3 marketplace. And companies deal with that all the 

4 time launching an organic product that may or may 

5 not have demand. So I don't see a reason to make 

6 an exception in this case for these guys either. 

7 So I oppose this.

8 MEMBER AUSTIN: Francis.

9 MEMBER THICKE: There's plenty of 

10 organic oats in the Midwest and we could grow a lot 

11 more.

12 VICE CHAIR CHAPMAN: Please do so.

13 MEMBER AUSTIN: Any further questions 

14 or discussion? Seeing none I present this to the 

15 Board for vote and discussion. 

16 This does come from the subcommittee as 

17 a motion with a second. The motion to classify oat 

18 beta-glucan as agricultural. The motion was made 

19 by Lisa, seconded by Ashley. Tracy, I'll turn it 

20 over to you.

21 CHAIR FAVRE: Okay, we're going to 

22 start the voting with Jesse.
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1 MEMBER BUIE: Yes.

2 MEMBER BECK: Yes.

3 MEMBER SWAFFAR: Yes.

4 MEMBER ROMERO-BRIONES: Yes.

5 MEMBER DE LIMA: Yes.

6 VICE CHAIR CHAPMAN: Yes.

7 MEMBER SEITZ: Yes.

8 MEMBER RICHARDSON: Yes.

9 MEMBER BEHAR: Yes.

10 MEMBER SONNABEND: Yes.

11 MEMBER RICE: Yes.

12 MEMBER OAKLEY: Yes.

13 MEMBER THICKE: Yes.

14 MEMBER AUSTIN: Yes, ma'am.

15 CHAIR FAVRE: The ghost of Mac has 

16 entered the room. The chair votes yes.

17 MEMBER DE LIMA: It's 15 yes, zero no. 

18 The motion passes.

19 MEMBER AUSTIN: Listing motion, to 

20 move and list oat beta-glucan at 205.606 of the 

21 National List. 

22 This motion was made by Lisa, seconded 
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1 by Jean.

2 CHAIR FAVRE: Okay, we'll start the 

3 voting with Carmela.

4 MEMBER BECK: No.

5 MEMBER SWAFFAR: No.

6 MEMBER ROMERO-BRIONES: No.

7 MEMBER DE LIMA: No.

8 VICE CHAIR CHAPMAN: No.

9 MEMBER SEITZ: No.

10 MEMBER RICHARDSON: No.

11 MEMBER BEHAR: No.

12 MEMBER SONNABEND: No.

13 MEMBER RICE: No.

14 MEMBER OAKLEY: No.

15 MEMBER THICKE: No.

16 MEMBER AUSTIN: No.

17 MEMBER BUIE: No.

18 CHAIR FAVRE: The chair votes no.

19 MEMBER DE LIMA: Zero yes, 15 no. The 

20 motion fails.

21 MEMBER AUSTIN: Thank you. Moving 

22 onto our next proposed petitioned material, 
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1 hypochlorous acid. I'll turn it over to Dr. 

2 Brines.

3 DR. BRINES: Thank you. As mentioned 

4 yesterday this material was petitioned on May 29, 

5 2015 by Botanical Food Company and requests the 

6 addition of hypochlorous acid to Section 205.601 

7 of the National List as well as 205.605.

8 It was also added to the agenda of the 

9 Livestock Subcommittee at the request of the 

10 National Organic Program.

11 In support of the review a technical 

12 evaluation report was commissioned and completed 

13 in 2015 which addresses all uses.

14 This is the first meeting at which the 

15 subcommittee is considering the petition. Thank 

16 you.

17 MEMBER AUSTIN: Thank you. Ashley?

18 MEMBER SWAFFAR: So, we did have the 

19 petition to list hypochlorous acid across all three 

20 scopes - livestock, handling and crops.

21 Francis did a great job yesterday in 

22 livestock reviewing the process of production of 
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1 hypochlorous acid so I won't dive into that again.

2 There were comments in support of the 

3 addition of hypochlorous acid including those who 

4 said it was easy for us to use, it's more friendly 

5 to the environment, it was a highly effective 

6 sanitizer and it's essential to my business.

7 There was concern raised about the 

8 language in the motion and which we'll correct with 

9 an amendment. 

10 And there was other concern that we 

11 should evaluate all sanitizers as a grouping. And 

12 I do believe we will be looking into that.

13 MEMBER AUSTIN: Thank you. Do we have 

14 any questions, discussion from the Board or the 

15 subcommittee? Tom.

16 VICE CHAIR CHAPMAN: I think this is 

17 fairly similar to the discussion we already had 

18 with livestock. I do intend to make a motion to 

19 amend after the classification.

20 MEMBER AUSTIN: Okay, thank you. Any 

21 other discussion? 

22 Okay, so this comes before the Board as 
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1 a motion from the subcommittee with a second. The 

2 classification motion. We move to classify 

3 hypochlorous acid as synthetic. That motion was 

4 made by Ashley and seconded by Jean. Tracy?

5 CHAIR FAVRE: Okay, we're going to 

6 start the voting with Ashley.

7 MEMBER SWAFFAR: Yes.

8 MEMBER ROMERO-BRIONES: Yes.

9 MEMBER DE LIMA: Yes.

10 VICE CHAIR CHAPMAN: Yes.

11 MEMBER SEITZ: Yes.

12 MEMBER RICHARDSON: Yes.

13 MEMBER BEHAR: Yes.

14 MEMBER SONNABEND: Yes.

15 MEMBER RICE: Yes.

16 MEMBER OAKLEY: Yes.

17 MEMBER THICKE: Yes.

18 MEMBER AUSTIN: Yes.

19 MEMBER BUIE: Yes.

20 MEMBER BECK: Yes.

21 CHAIR FAVRE: The chair votes yes.

22 MEMBER DE LIMA: Fifteen yes, zero no. 
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1 The motion passes.

2 MEMBER AUSTIN: Listing motion. Tom.

3 VICE CHAIR CHAPMAN: So, it's 

4 preferable to have a listing in a motion that's the 

5 same across all the subcommittees.

6 And to be explicit the petition 

7 subcommittee review and technical review were all 

8 for hypochlorous acid generated via electrolyzed 

9 water. 

10 Therefore I move to amend the petition 

11 to read "hypochlorous acid generated via 

12 electrolyzed water as petitioned."

13 MEMBER BEHAR: I'll second.

14 MEMBER AUSTIN: We have a motion to 

15 amend with a second. Is there any further 

16 discussion?

17 Hearing none we'll proceed to vote. 

18 Tracy?

19 CHAIR FAVRE: Okay, we'll start the 

20 vote with A-dae.

21 MEMBER ROMERO-BRIONES: Yes.

22 MEMBER DE LIMA: Yes.
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1 VICE CHAIR CHAPMAN: Yes.

2 MEMBER SEITZ: Yes.

3 MEMBER RICHARDSON: Yes.

4 MEMBER BEHAR: Yes.

5 MEMBER SONNABEND: Yes.

6 MEMBER RICE: Yes.

7 MEMBER OAKLEY: Yes.

8 MEMBER THICKE: Yes.

9 MEMBER AUSTIN: Yes.

10 MEMBER BUIE: Yes.

11 MEMBER BECK: Yes.

12 MEMBER SWAFFAR: Yes.

13 CHAIR FAVRE: The chair votes yes.

14 MEMBER DE LIMA: Fifteen yes, zero no. 

15 The motion passes.

16 CHAIR FAVRE: Okay, just as a reminder 

17 we had had an amendment to the motion. Now we have 

18 to vote on the motion.

19 MEMBER AUSTIN: So now we'll have the 

20 vote on the motion as amended to list hypochlorous 

21 acid. Tom, do you want to go ahead and read your 

22 amendment to the motion? Or do we just vote on the 
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1 motion now?

2 VICE CHAIR CHAPMAN: You just vote on 

3 the main motion. Do you want me to read it? I can 

4 read it.

5 MEMBER AUSTIN: Go ahead, since you 

6 made the amendment to it.

7 VICE CHAIR CHAPMAN: So it's a move to 

8 list hypochlorous acid generated via electrolyzed 

9 water as petitioned at 205.605(b) Chlorine 

10 Materials.

11 CHAIR FAVRE: Okay, we've had a motion. 

12 We are going to start with Lisa on the vote.

13 MEMBER DE LIMA: Yes.

14 VICE CHAIR CHAPMAN: Yes.

15 MEMBER SEITZ: Yes.

16 MEMBER RICHARDSON: Yes.

17 MEMBER BEHAR: Yes.

18 MEMBER SONNABEND: Yes.

19 MEMBER RICE: Yes.

20 MEMBER OAKLEY: Yes.

21 MEMBER THICKE: Yes.

22 MEMBER AUSTIN: Yes.
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1 MEMBER BUIE: Yes.

2 MEMBER BECK: Yes.

3 MEMBER SWAFFAR: Yes.

4 MEMBER ROMERO-BRIONES: Yes.

5 CHAIR FAVRE: The chair votes yes.

6 MEMBER DE LIMA: Fifteen yes, zero no. 

7 The motion passes.

8 MEMBER AUSTIN: Thank you. Okay, 

9 we'll move onto our next petition material and this 

10 will deal with sodium dodecylbenzene sulfonate. 

11 I'm the lead on that one.

12 DR. BRINES: Harold, would you like me 

13 to introduce it before you jump in? Would you like 

14 me to introduce the petitioned substance first?

15 MEMBER AUSTIN: Would you please?

16 DR. BRINES: Thank you. All right. 

17 The substance was petitioned by Ecolab 

18 Incorporated on October 13, 2015.

19 The petition requests the addition of 

20 sodium dodecylbenzene sulfonate to Section 205.605 

21 of the National List as an antimicrobial.

22 There was no technical evaluation 
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1 report requested or developed for this petitioned 

2 substance and this is the first meeting at which 

3 it's being discussed by the NOSB. Thank you.

4 MEMBER AUSTIN: Thank you. Okay, so 

5 we have before us a petition and a proposal coming 

6 out of the subcommittee to list sodium 

7 dodecylbenzene sulfonate, from now on SDBS.

8 This was a petition we received from 

9 Ecolab to add this material to the National List 

10 at 205.605(b) for use as one of two active 

11 ingredients, the other being lactic acid in their 

12 formulated product antimicrobial fruit and 

13 vegetable treatment AFVT as an antimicrobial.

14 This would be used in treating raw and 

15 ready to eat fruits and vegetables in the premises 

16 of organic retail establishments such as 

17 restaurants, cafeterias, food service operations, 

18 kitchens, et cetera.

19 The petitioners do not formulate the 

20 product, but purchase it from one of three 

21 manufacturing sources as listed in the proposal.

22 The final product would be used in a 
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1 wash water application on raw fruits and vegetables 

2 or on work surfaces used to prepare these raw fruit 

3 and ready to eat fruits and vegetables.

4 This material is currently widely used 

5 in detergents, cleaners, sanitizer products and 

6 other numerous industrial type products.

7 The petitioner says that this material 

8 would provide organic handlers with a new reliable 

9 tool to aid in the battle against microorganisms 

10 that cause foodborne illnesses and outbreaks such 

11 as E. coli, Listeria and Salmonella.

12 There are several ways to make this 

13 material. The primary source is to start with 

14 linear alkylbenzene sulfonate which is made by 

15 sulfonation of alkylbenzenes prepared from 

16 petroleum distillates.

17 These processes have been quite 

18 substantially refined in modern, recent times.

19 According to the information provided 

20 the sulfonation technology has been considerably 

21 improved and with the most modern systems currently 

22 beginning to use falling film reactors, or 
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1 mono-tube and multi-tube as part of the sulfonation 

2 process, primarily in Europe.

3 So they're looking to add this as a 

4 processing aid in their antimicrobial material.

5 Part of the discussion I want to have 

6 is with the implementation of the Food Safety 

7 Modernization Act this material could possibly be 

8 a useful addition to the National List.

9 There does not appear to be any serious 

10 human health or environmental concerns under the 

11 proposed use pattern according to the EPA 206 

12 registration eligibility document, or RED.

13 One area of concern that the 

14 subcommittee was hoping that we could get some 

15 clarification on was regarding the mention that 

16 according to one report, Estrin et al., 1982, 

17 states that there could possibly be some impurities 

18 such as neutral oil, arsenic, iron, possible lead 

19 contamination.

20 Those concerns I think for myself as the 

21 lead were a little bit eliminated during the public 

22 presentation by the manufacturer's rep that gave 
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1 oral testimony to us the other day saying that with 

2 the new formulations, the new processes that those 

3 were pretty much negligible at this particular 

4 juncture now.

5 It's the hope of the subcommittee that 

6 we could also get some information helping us 

7 address this concern.

8 I also would like at this point to 

9 clarify a mistake in the document that they 

10 addressed, pointed out to us during the public 

11 comment period.

12 In the fifth paragraph of the 

13 subcommittee proposal under the discussion portion 

14 it states, "Its use and compatibility with organic 

15 crop production." That was erroneous. It should 

16 read, "Its use and compatibility with organic 

17 handling and food processing." And we apologize 

18 for that oversight in the preparation on our part.

19 There are alternatives mentioned such 

20 as lactic acid, citric acid, acidified sodium 

21 chlorite as well as peracetic acid that are 

22 currently being used and allowed for use in organic 
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1 handling.

2 The subcommittee had three specific 

3 questions to try and gather more information back. 

4 What are retailers currently doing? Are there 

5 alternatives mentioned in the petition currently 

6 being used at the retail level? And if so, how 

7 effective are they in addressing these food safety 

8 concerns?

9 Also at what level, if any, were the 

10 impurities? Which we did get an answer back on 

11 that.

12 We had 10 specific comments back in 

13 writing. We received five comments during the 

14 oral in-person testimony, two for, one neutral, and 

15 two opposed.

16 Those opposed including three consumer 

17 groups and one industry group were concerned with 

18 the environmental impact, that it does not reach 

19 the benchmark of being essential.

20 We had very little data compiled on 

21 human health impact. 

22 And there were certain concerns over 
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1 the potential contaminants that I think we got 

2 answered yesterday.

3 And also that alternatives exist, and 

4 that it's not compatible with organic principles. 

5 And it was pointed out that the 

6 subcommittee did not request a TR on this material.

7 Those supporting the listing of this 

8 material, there were six. They stated that it was 

9 essential at the retail level for raw and ready to 

10 eat fruits and vegetables, that it will help 

11 grocers and retailers improve food safety for 

12 organic consumers and customers via increased 

13 efficacy on pathogenic and spoilage organisms.

14 The product AFVT is specifically 

15 designed for this need and use, whereas citric acid 

16 or lactic acid do not achieve the same level of 

17 efficacy as this formulated material would.

18 It also states that they disagree with 

19 the subcommittee about raising concerns over the 

20 human health exposure.

21 It is diluted at the point of use and 

22 applied via automatic dilution system to help 
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1 minimize the exposure.

2 I would make comments back to that 

3 concern in their comments raised back to us that 

4 they're referencing the end use product, AFVT. 

5 Our concern was at the point of manufacture and 

6 transportation and dealing with the sodium 

7 dodecylbenzene sulfonate itself rather than the 

8 finished formulated product.

9 I'd also point out that this was a 

10 912-page petition that dealt with, in part, the 

11 material itself, SDBS, but quite extensively to the 

12 finished formulated material. So, there were a 

13 lot of moving parts and there was a lot of sifting 

14 that we had to do as we went through this petition 

15 review.

16 They also defend that -- we raised a 

17 concern that this material was not GRAS. 

18 There's also -- one public commenter 

19 pointed out that we should not consider moving 

20 forward with this material without first asking for 

21 a TR.

22 One other comment pointed out to the 
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1 full Board that sodium dodecylbenzene sulfonate, 

2 CAS 2555-30-0, is currently listed on EPA's Safer 

3 Choice Ingredients List, or SCIL.

4 With that I'll open it up for questions 

5 or discussions from the Board. Jean.

6 MEMBER RICHARDSON: Yes, I'm on the 

7 Handling Subcommittee. One of the reasons why we 

8 didn't, as you recall, request a TR was that during 

9 our analysis of the petition and our ensuing 

10 discussion we felt that it would be unlikely that 

11 we would be approving this. 

12 And therefore our vote to list it as you 

13 can see is one yes and five no with one abstention 

14 and one absent. And so therefore we felt that it 

15 would be a waste of money to request a TR when we 

16 were probably not going to be listing this based 

17 on our initial analysis.

18 And I must say sitting in the consumer 

19 seat and looking at the comments that have come in 

20 I try to imagine myself going into the supermarket, 

21 into Lisa's supermarket, and seeing a sign over the 

22 veggies there that says "Don't worry, this has been 
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1 sprayed with sodium dodecylbenzene sulfonate." 

2 And I would certainly be voting against this, 

3 assuming that we got to vote on this today.

4 MEMBER AUSTIN: Thank you, Jean. Tom?

5 VICE CHAIR CHAPMAN: I think I was the 

6 abstain vote, but I don't quite remember.

7 MEMBER AUSTIN: You were.

8 VICE CHAIR CHAPMAN: I definitely 

9 wasn't the yes, but I think I was the abstain. And 

10 I was torn on this issue.

11 The petitioner and other people have 

12 talked about its use in organic restaurants and 

13 retail establishments, areas that don't require 

14 certification today. So unfortunately you may not 

15 actually ever see that sign because there is 

16 somewhat of a lack of oversight in those areas.

17 But that was part of the reason why I 

18 wasn't convinced on this substance either because 

19 it's kind of a quandary area where it may be used 

20 without any review, and even if we do review it and 

21 allow its use or don't allow its use it still may 

22 go on being used in these areas.
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1 I was also very interested in learning 

2 why alternatives like PAA and hypochlorous acid 

3 couldn't get used because those seem like best in 

4 class sanitizers.

5 There was some public comment back 

6 about the market availability in restaurant and 

7 retail like settings.

8 I am not fully convinced of that yet, 

9 but would still like to learn a lot more. 

10 Actually, I've tried to find PAA and hypochlorous 

11 acid for myself in my home to use and I have yet 

12 to successfully find it. So, I mean, there's 

13 probably some truth to that, but I'd like to learn 

14 more about that.

15 But I'm now ready to send this back to 

16 subcommittee based on actually some recent press 

17 I've been reading.

18 There was a great article that came out 

19 this year in the Tampa Bay Times about the amount 

20 of fraud in farm-to-table restaurants.

21 And there was a great article that just 

22 came out I think a week ago in Civil Eats about the 
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1 importance of organic restaurant certification.

2 And so as we look more into that I don't 

3 want to knock off a material that may be used in

4 that setting. 

5 Also keeping in mind that this is a SCIL 

6 listed material I think it's worth our time now to 

7 commission the technical review and get more 

8 information on it before we come to a conclusion.

9 MEMBER RICHARDSON: Could you clarify 

10 the SCIL listing?

11 VICE CHAIR CHAPMAN: Harold, do you 

12 want to speak to that? The SCIL listing.

13 MEMBER AUSTIN: SCIL, that's the EPA's 

14 -- it's the lack of the current and active EPA 

15 lists, list 3, list 4.

16 CHAIR FAVRE: Speak up some if you 

17 would, Harold.

18 MEMBER AUSTIN: With the lack of the 

19 active, the currently non-active list 3, list 4 

20 ingredient lists, this is EPA's Safer Choice 

21 Ingredient List which is something that we as a 

22 Board have been discussing quite in-depth amongst 
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1 ourselves.

2 This is a material that is actually 

3 listed on that list. And I think, like yourself, 

4 Tom, because that's a venue that we're going to down 

5 the road probably be utilizing for several things 

6 that we'll be working that are currently on our 

7 National List that we may be looking to move some 

8 of these materials, or some of the materials that 

9 we would be utilizing off of that list that I think 

10 this is an important one that we should probably 

11 maybe move back to the subcommittee and take 

12 another look at as well.

13 But Zea, do you want to give us your 

14 comments?

15 MEMBER SONNABEND: Currently the SCIL 

16 list contains active ingredient as well as inert 

17 ingredients.

18 The program we're talking about 

19 establishing would only be for inert ingredients, 

20 and it really wouldn't apply to active ingredients.

21 That being said, I was not aware that 

22 it was on the SCIL list and I would have questions 
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1 about why. And I don't know how much they share 

2 their information on the things they've reviewed

3 because I haven't -- actually since I wasn't aware 

4 I haven't tried to look it up.

5 But it begs the question to me of if it's 

6 a safer choice, then safer than what? And because 

7 we didn't do a TR we haven't explored those issues. 

8 So, I voted no in the committee and I 

9 would never change my vote to yes without a TR. But 

10 I'm sort of neutral about sending it back to the 

11 committee. I'm not -- I would go along with that, 

12 but I would also just vote no today and find out 

13 why it's on SCIL later if that's a good idea.

14 MEMBER AUSTIN: Jean, then Emily.

15 MEMBER RICHARDSON: I'm not in favor of 

16 sending it back to the subcommittee. I think that 

17 certainly we discussed it on two or three of our 

18 subcommittee calls. I'm very comfortable with 

19 voting it not to be added to the list.

20 Especially, you know, at some point in 

21 the future with all the food safety we may be forced 

22 to use things in organic that we would prefer not 
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1 to.

2 But I think that we've in a way set the 

3 bar higher with our new sunset in a way so that the 

4 material once we put it on the list is going to be 

5 there maybe for longer than we might want. It 

6 doesn't drop off any more like it used to in the 

7 olden days.

8 And so therefore to me it sort of sets 

9 the bar quite higher. Just because it's on the 

10 SCIL list doesn't indicate to me that it's really 

11 something that I would want to see in the organic 

12 stream.

13 MEMBER OAKLEY: I'm not on the Handling 

14 Subcommittee but I'm perfectly comfortable voting 

15 for it today and would like to do that. And I would 

16 be voting no.

17 MEMBER AUSTIN: Harriet.

18 MEMBER BEHAR: Well, this brings up 

19 what many public commenters brought up was that we 

20 don't really have a framework for reviewing the 

21 sanitizers and disinfectants.

22 And so we look at them one by one, but 
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1 it's almost like we should have our own organic list 

2 of the preferred and be able to then compare.

3 And I think it is a good thing to have 

4 a variety of sanitizers and disinfectants who have 

5 the same sort of rotation.

6 But again, without having that

7 framework and really knowing which is the better 

8 choice. Not that I dislike the EPA, but I would 

9 like to have a chance to dig into some of it rather 

10 than just taking carte blanche acceptance of 

11 something that's on an EPA list. Especially not 

12 knowing how they're choosing.

13 So, I just don't know if we're putting 

14 that on a work plan or not to try to provide us with 

15 a little bit more background when we are deciding 

16 on sanitizers and disinfectants to help us with 

17 those decisions.

18 MEMBER AUSTIN: Tom, then Ashley.

19 VICE CHAIR CHAPMAN: Yes, I mean 

20 perhaps I should not have mentioned SCIL because 

21 the conversation has now devolved to just talking 

22 about SCIL.
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1 I mean, the reason for me wanting to 

2 send it back is I want to foster and grow organic 

3 certification in the restaurant area given the 

4 amount of fraud documented in some of these recent 

5 articles that have been coming out.

6 And it's an optional certification. 

7 So, if we don't list this material and they continue 

8 to use it, they can, and then maybe they choose not 

9 to get organic certified and provide that greater 

10 level of confidence to the consumers.

11 I'm not saying when we get this I want 

12 to vote yes on this material. I just want more 

13 information. I wasn't comfortable at the time we 

14 voted on it, and I wasn't completely certain that 

15 we needed to get more information. I was somewhere 

16 between a no and more information. 

17 And since then I don't see the harm in 

18 getting more information at this time. 

19 There's no rush. There's no reason to 

20 make a decision here. It's not allowed today. 

21 There's no weirdness about that. And let's get the 

22 more information and then make a decision based on 
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1 that.

2 MEMBER AUSTIN: Thank you, Tom. 

3 Ashley?

4 MEMBER SWAFFAR: A couple of 

5 questions. Harold, refresh my memory. If we 

6 arbitrarily vote on this today when the lead wants 

7 to take this back to committee -- sorry.

8 If we decide to vote on this today and 

9 it is denied it can never be brought back again, 

10 correct? Never be repetitioned without --

11 MEMBER AUSTIN: They can bring it back 

12 if they can come back with additional and useful 

13 information in the future.

14 MEMBER SWAFFAR: So, if there is actual 

15 organic certification of more grocery stores and 

16 food restaurants that could?

17 VICE CHAIR CHAPMAN: But would that be 

18 more information? I mean, how many times has a 

19 petition been brought back based on more 

20 information? Does the program know?

21 DR. BRINES: Do you want me to answer 

22 that, Tom?
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1 VICE CHAIR CHAPMAN: Sure.

2 DR. BRINES: Okay, thanks. Yes, we do 

3 -- well, frequently we get inquiries after a 

4 substance has been voted down by the Board of what 

5 the process is to appeal that decision.

6 And our advice is always that the 

7 process would be to submit a petition for further 

8 consideration by the Board.

9 In order to meet the requirement for 

10 eligibility to have that petition reviewed a second 

11 time around the burden is on the petitioner to 

12 provide new information that was not considered by 

13 the Board during its original review, and to 

14 highlight that information so it's clear why it's 

15 coming up.

16 One other consideration is that in your 

17 policy and procedures manual there is criteria for 

18 how petitions get prioritized. And petitions that 

19 have been voted down by the Board and are coming 

20 back as a repetition are assigned the lowest 

21 priority for review.

22 MEMBER AUSTIN: Thank you. Lisa?
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1 MEMBER DE LIMA: So, if we went ahead 

2 and reviewed all the sanitizers as a group as 

3 Harriet was asking if we were going to do, and then 

4 we decided that the subcommittee wanted to bring 

5 the item back under a petition, would that change 

6 the order of the priority of the petition?

7 MEMBER AUSTIN: If we voted it down 

8 right now then it would be up to the petitioner to 

9 bring forth new pertinent information for us for 

10 reconsideration.

11 If we bring it back to the subcommittee 

12 we could slow it up to move it along with the 

13 sanitizers. But we do not have -- right now we do 

14 not have that as one of our work plan or work agenda 

15 items.

16 MEMBER DE LIMA: But we could add it.

17 MEMBER AUSTIN: But we could. Zea, 

18 Emily.

19 MEMBER SONNABEND: Well, I would 

20 suggest that if we did vote it down and decided what 

21 Harriet recommended, to look at all the sanitizers 

22 and do a TR comparing all the sanitizers including 
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1 this one the results of that TR would be new 

2 information about the alternatives. And 

3 therefore we could put this back on the table 

4 without a whole new petition.

5 I mean, that's my interpretation and 

6 the department would have to weigh in on it. But 

7 it's new information about alternatives, so we 

8 should be able to reconsider it.

9 MEMBER AUSTIN: Emily, then Tom.

10 MEMBER OAKLEY: Well, I was just going 

11 to note that since so many voted against it in the 

12 Handling Subcommittee the first time around

13 presumably there were compelling reasons for that.

14 And I'm guessing that's the manufacture 

15 process and the ingredients. So, could someone 

16 elaborate on that?

17 MEMBER AUSTIN: The rationale behind 

18 that was looking at the list of materials that this 

19 ingredient was currently being used in which was 

20 heavy industrial sanitizers, soaps and detergents 

21 we had concerns over the impurities from the 

22 processing process were kind of some of the main 
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1 ones.

2 And then just the material itself had 

3 given us some causes for concern without -- but 

4 again, we were making this decision based off of 

5 a 912-page petition and not the help of a TR at that 

6 juncture. Tom.

7 VICE CHAIR CHAPMAN: And another 

8 reason why we didn't vote for it was, I mentioned 

9 it earlier, but we have some of these other 

10 sanitizers already on the list that we consider 

11 very best in class based on what we know right now, 

12 and questioned the need for another one. Why 

13 couldn't those be used. 

14 And that was something we were trying 

15 to get people to comment on which we did receive 

16 a comment on.

17 I'm a little -- one question is I'm not 

18 aware of any recent time when the Board has 

19 petitioned a substance itself back to the Board. 

20 I know we've done annotation changes, but I can't 

21 think of any recent time where a petition for a 

22 substance came from the Board.
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1 So I question if we reject this now if 

2 it would really come back via the Board.

3 And I just don't understand the harm of 

4 getting more information.

5 MEMBER RICHARDSON: Call the question.

6 CHAIR FAVRE: Okay, the question has 

7 been called. Do we have a second?

8 MEMBER THICKE: Second.

9 CHAIR FAVRE: Okay. So, the question 

10 has been called and seconded. We need to move 

11 forward with the vote.

12 VICE CHAIR CHAPMAN: A vote on to call 

13 the question.

14 CHAIR FAVRE: Yes, a vote on calling 

15 the question.

16 VICE CHAIR CHAPMAN: Which is to end 

17 discussion.

18 CHAIR FAVRE: Yes. Start with Tom, is 

19 that right?

20 VICE CHAIR CHAPMAN: No.

21 MEMBER SEITZ: Yes.

22 MEMBER RICHARDSON: Yes.
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1 MEMBER BEHAR: No.

2 MEMBER SONNABEND: Abstain.

3 MEMBER RICE: No.

4 MEMBER OAKLEY: No.

5 MEMBER THICKE: I'm confused. We're 

6 voting on ending discussion?

7 VICE CHAIR CHAPMAN: Ending 

8 discussion. Any further motions to refer back to 

9 subcommittee, all that wouldn't be allowed. We 

10 would have to proceed to a vote on the motion.

11 MEMBER THICKE: Yes.

12 MEMBER AUSTIN: No.

13 MEMBER BUIE: No.

14 MEMBER BECK: No.

15 MEMBER SWAFFAR: No.

16 MEMBER ROMERO-BRIONES: No.

17 MEMBER DE LIMA: No.

18 CHAIR FAVRE: The chair votes yes. 

19 Schedule. 

20 MEMBER SONNABEND: Did it pass?

21 CHAIR FAVRE: We're waiting to get the 

22 count.
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1 VICE CHAIR CHAPMAN: We didn't get a 

2 clear and accurate count of the vote. 

3 CHAIR FAVRE: We didn't have a 

4 majority, let's just put it that way, right? All 

5 right. Three yes, one abstention.

6 All right, so the motion to call the 

7 question did not pass. 

8 VICE CHAIR CHAPMAN: I move to refer to 

9 subcommittee.

10 MEMBER BEHAR: I'll second.

11 CHAIR FAVRE: Okay, I have a motion and 

12 a second. Any further discussion?

13 MEMBER AUSTIN: So we have a motion and 

14 a second to refer this back to the subcommittee. 

15 Any further discussion? Francis.

16 MEMBER THICKE: Just one quick 

17 comment. I see the center of this molecule is a 

18 benzene ring.

19 MEMBER AUSTIN: Correct. Emily?

20 MEMBER OAKLEY: I just want to quickly 

21 point out that the Organic Produce Wholesalers 

22 Coalition does not want us to approve this 
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1 substance.

2 MEMBER AUSTIN: Any further 

3 discussion? Carmela. I keep skipping you, I'm 

4 sorry.

5 MEMBER BECK: I just wanted to say that 

6 I don't sit on the Handling Subcommittee and it's 

7 always helpful to get some context for the votes 

8 that are not in favor, that are not the majority 

9 vote.

10 So, I was wondering about that 

11 abstention. Correct. And so it was helpful for 

12 you to have provided that context. And that was 

13 helpful for me.

14 And so because of that I'm interested 

15 similarly to send it back so that we can do justice 

16 to the material.

17 MEMBER AUSTIN: Harriet.

18 MEMBER BEHAR: I seconded it to go back 

19 to subcommittee because I like to make decisions 

20 based on information and I don't feel like I have 

21 enough.

22 And I hope that part of that information 
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1 will be a larger review of sanitizers and 

2 disinfectants as a whole.

3 MEMBER AUSTIN: Scott.

4 MEMBER RICE: I just wanted to state 

5 that I would echo the comments of those that have 

6 wanted to send it back to subcommittee for further 

7 information for a more informed vote or review.

8 MEMBER AUSTIN: Any further 

9 discussion? If not, Tracy, I'll turn it over to 

10 you for a vote.

11 CHAIR FAVRE: Okay. Just so 

12 everybody's clear we're voting on the motion to 

13 send it back to subcommittee. And we're going to 

14 start that vote with Dan.

15 So a yes vote will send it back to 

16 subcommittee. Sorry, I wasn't sure if you were 

17 thinking or confused.

18 MEMBER SEITZ: No, I was thinking. 

19 And so long as it's done in the context of looking 

20 at the entire range of sanitizers I am fine with 

21 that. So, yes.

22 MEMBER RICHARDSON: No.
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1 MEMBER BEHAR: Yes.

2 MEMBER SONNABEND: Abstain.

3 MEMBER RICE: Yes.

4 MEMBER OAKLEY: No.

5 MEMBER THICKE: No.

6 MEMBER AUSTIN: Yes.

7 MEMBER BUIE: Yes.

8 MEMBER BECK: Yes.

9 MEMBER SWAFFAR: Yes.

10 MEMBER ROMERO-BRIONES: No.

11 MEMBER DE LIMA: No.

12 VICE CHAIR CHAPMAN: Yes.

13 CHAIR FAVRE: The chair votes yes.

14 MEMBER DE LIMA: Simple majority. So 

15 eight yes, six no, one abstain. The motion passes.

16 CHAIR FAVRE: The motion passes. 

17 Okay, this will be sent back to committee.

18 MEMBER AUSTIN: Okay. All right. 

19 We're going to continue to move forward, at least 

20 try to get one more material in before we break for 

21 lunch. That will be Madam Chair's decision.

22 The next proposal to bring forward is 
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1 on ancillary substances. Dr. Brines.

2 MEMBER SONNABEND: This is not one for 

3 Lisa because it's not a petitioned item. 

4 MEMBER AUSTIN: Okay, Zea.

5 MEMBER SONNABEND: So, I'm going to 

6 launch right into this.

7 Ancillary substances has been 

8 discussed for several years now. We passed an 

9 overall policy on NOSB review of these in 2014. 

10 And we've been trying to follow through on that 

11 proposal ever since.

12 It has been sent back a couple of times 

13 and now I think we have a procedure that will work.

14 This is a very arcane topic and so I'm 

15 going to give some sort of a review flow chart so 

16 that new members of the Board in particular can be 

17 clear how this is going to work.

18 So, the document itself that we've put 

19 forward gives the definition of ancillary 

20 substances and then talks about how the NOSB will 

21 review it.

22 A lot of feedback we got was from 
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1 certifiers from the previous versions who were 

2 confused and concerned that this would require too 

3 much extra paperwork and not be easy to follow 

4 through on.

5 Okay, so this is the flow. The first 

6 thing is a petition for a substance comes in, or

7 else the sunset process starts to review something 

8 on the National List.

9 Those would be in effect, you know, the 

10 active ingredient or the main substance of what 

11 we're reviewing.

12 These things come along with other 

13 ingredients that we're calling ancillary 

14 substances. And this is to distinguish it from 

15 other ingredients in crops products which are 

16 normally known as inert ingredients, even though 

17 we all know they're not inert. But we can't call 

18 everything an other ingredient.

19 So, when we start this process we 

20 generally commission a technical report. And each 

21 TR for those substances that may contain 

22 ancillaries will have a chart of the ancillary 
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1 substances in use and I'll give an example in a 

2 second.

3 The TR will evaluate those ancillaries 

4 along with each substance for each of the criteria 

5 in OFPA and the special handling criteria.

6 Any ancillaries that could be used that 

7 do not meet those criteria will be flagged in the 

8 technical report.

9 And this is a new part that we've added 

10 for this meeting. Any that are on the IARC list 

11 or NTP list of problematic ones causing cancer and 

12 others will be flagged in the technical report.

13 Here is an example. The first one we 

14 took up was microorganisms and dairy cultures. 

15 And this is by functional class. So this shows, 

16 you know, these are anti-caking agents, these are 

17 carriers and fillers. Then there's some 

18 preservatives, stabilizers, cryoprotectants and 

19 then substrate.

20 So, it should be mentioned that because 

21 these substances are generally on the National List 

22 and are used in a microorganism, for instance, a 
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1 microorganism might be 1 or 2 percent of a final 

2 product that's formulated. It's allowed in 

3 organic products in the 95 percent category.

4 And then the ancillary substance might 

5 be 0.5 of that 1 percent in many cases. So these 

6 are things that are used in very small amounts.

7 In a lot of cases they're used up. 

8 Like, a lot of these are the growth media, the 

9 substrate. And so they're just common 

10 agricultural products. 

11 But sometimes they are stabilizers or 

12 what's known as standardizing agents so that a 

13 substance will have the same content every time you 

14 use it. So there's a variety of functional classes 

15 that these are used for.

16 So, this chart, for each item that has 

17 ancillary substances will be in the TR. 

18 Okay. Once we get the TR back we will 

19 review the TR, the Handling Subcommittee. And 

20 that will include the chart of ancillary substances 

21 and how each ancillary substance is affected by the 

22 criteria that the TR contractor reviews.
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1 What is called the baseline criteria is 

2 what we, the NOSB, use when we look at ancillary 

3 substances. And those are listed in the document. 

4 We've looked at whether it's on the National List 

5 already, that it's GRAS, that it's a direct food 

6 additive and therefore allowed by the FDA, and now 

7 that it is not on these lists of IARC or NTP.

8 So, the flagged ones that we decide not 

9 to accept will be in the proposal for posting for 

10 public comment along with the chart.

11 If it's sunset it will be in the first 

12 posting. If it's a new petition it will be in the 

13 posting.

14 And we will ask for input from the 

15 stakeholders. If they have additional ancillary 

16 substances they're aware of that were not looked

17 at in the TR, if they have ones they think are 

18 problems that were not flagged in the problem ones, 

19 all of that will be posted for public comment so 

20 everyone can weigh in on that.

21 Then we take all that public comment. 

22 We pass our proposal or complete our sunset review. 
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1 And any of those ancillary substances that get in 

2 with the substance are then accepted. And if we 

3 have any that are prohibited, right now it says for 

4 sunset if they're prohibited we have to have a 

5 separate proposal coming forward to specifically 

6 prohibit them. That will come along with the same, 

7 you know, at the meeting that we complete our sunset 

8 review.

9 So, this then doesn't take effect until 

10 the NOP does rulemaking for the sunset review or 

11 for the petition to add it to the National List.

12 And then after that is where the ACA 

13 responsibilities kick in. They need to consult 

14 the chart that was published of these are the 

15 ancillary substances that are allowed.

16 They don't have to do anything 

17 additional if it's been approved on the list. But 

18 if there's a new ancillary substance that appears 

19 we have a proposed template that they use with some 

20 slightly modified criteria in the document that 

21 they could use to determine compliance of new 

22 ancillary substances only.
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1 The template is not -- we're not posing 

2 it as a requirement. It was just some suggestions. 

3 And that they would also then have to consult the 

4 lists themselves to make sure it wasn't on those 

5 lists for any new ancillary substance.

6 So, I think we have a procedure that is 

7 workable. We still have a bit of certifier concern 

8 over paperwork, but not nearly -- most of the 

9 certifiers felt it was achievable that we heard 

10 from. 

11 And while we still definitely get some 

12 comments from groups that want every ancillary 

13 reviewed on the National List individually that is 

14 going to be way beyond my term on the Board. And 

15 so if anybody really wants to do that you can vote 

16 no, but then you need to be prepared to take this 

17 on for the next five years as far as I'm concerned.

18 So, I am done working on this subject. 

19 If we don't pass this we are -- someone else is 

20 taking it on.

21 But I think -- oh, so one other point 

22 I do have to address is some people were concerned 
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1 that things, particularly ethyl alcohol and meat, 

2 would not be able to be used because they do appear 

3 on the list.

4 Emily Brown Rosen checked up the actual 

5 wording on those lists for us and it specifically 

6 says ethyl alcohol in alcoholic beverages. It 

7 doesn't list everything on those lists by use and 

8 application, but it does list those too.

9 And besides, hopefully the first TR for 

10 the substance would catch the fact that there was 

11 ethanol in it, and it would be on the chart, and 

12 therefore we would have approved it in spite of the 

13 lists if we wanted to, because we would approve it.

14 Same thing for meat. It says on the 

15 list meat for human consumption. If someone wants 

16 to put some burgers in your microorganisms or 

17 whatever it would appear on this list hopefully and 

18 be approved. So, I do think those concerns are 

19 addressed and there's no reason not to move forward 

20 with this proposal.

21 MEMBER AUSTIN: Thank you, Zea. 

22 Francis, then Harriet.
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1 MEMBER THICKE: Yes. Zea, for the 

2 last round of sunsets we had a lot of new TRs. And 

3 so when they come up again will we have to do another 

4 TR for them?

5 MEMBER SONNABEND: So far the 

6 microorganisms which was a sunset 2016 item we 

7 decided to do as a pilot project until we could get 

8 the procedure in place.

9 During the 2017 sunset we did prepare 

10 the charts for pectin which is very short and for 

11 yeast.

12 But once the procedure is in place a 

13 chart would have to be created for the other things 

14 we reviewed in 2017. But we haven't discussed 

15 amongst ourselves whether we're going to back up 

16 and do that for those things, or whether we're going 

17 to wait for the next sunset review. That is not 

18 determined yet.

19 VICE CHAIR CHAPMAN: Dairy cultures as 

20 well.

21 MEMBER SONNABEND: Well, we added 

22 dairy cultures in with this one. 
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1 But there are some things that we did 

2 approve last time including enzymes and vitamins 

3 and minerals, those in particular. There are a few 

4 others that may have had a few ancillary substances 

5 but those are big ones that there needs to be some 

6 definite scrutiny on the chart.

7 MEMBER AUSTIN: Harriet, then Emily.

8 MEMBER BEHAR: So, I'm trying to 

9 understand how this works. So we get 

10 microorganisms and maybe the Board would vote that 

11 only microorganisms that contain the preservative 

12 ascorbic acid could be used. Is that right?

13 And then only those formulations would 

14 be approved by the ACA? I'm just trying to --

15 that's the way. So, okay.

16 MEMBER SONNABEND: If you wanted to do 

17 that you could do that.

18 We did already vote this one with this 

19 chart in it. But you could have at the time pulled 

20 one or more of these off and said I don't want to 

21 approve these as having been reviewed.

22 MEMBER BEHAR: Okay, so just as a 
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1 follow-up since organic is kind of a continuous 

2 improvement, I mean it's -- I don't know how to put

3 it in place and I like what you've done so far.

4 But it would be nice to have almost a 

5 list of like the preferred ancillary and then try 

6 to push the manufacturers towards moving towards 

7 that.

8 Because that might be part of the issue 

9 is that not everything that's necessary in the 

10 product has the ancillary ingredients that we like 

11 the most.

12 So, I don't want to stop the use of the 

13 main ingredient based on that the ancillary might 

14 be a problem.

15 But it might be nice for manufacturers 

16 to know that there are customers out there that 

17 would prefer to use an ingredient that had a 

18 preferred ancillary.

19 And I'm sorry I don't have that in my 

20 head exactly how to do that. But it's just, you 

21 know. Because there's a lot of things on this list 

22 that are more preferable than others.
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1 MEMBER SONNABEND: Achieving that 

2 involves joining the Handling Subcommittee and 

3 spending all of your NOSB time on ancillary 

4 substances. So you're welcome to.

5 MEMBER AUSTIN: Emily.

6 MEMBER OAKLEY: I definitely 

7 understand that this is a complicated subject and 

8 far beyond my knowledge level, but I have a 

9 question. 

10 So, I realize there are hundreds of 

11 materials that couldn't possibly all be reviewed 

12 individually in one fell swoop.

13 My concern is if a new substance comes 

14 up is it essentially up to the accrediting 

15 certifying agency to like approve it so to speak? 

16 Because they're against these criteria certainly. 

17 But they're sort of performing an NOSB function on 

18 some level at that point. Is that correct, or 

19 would you characterize it differently?

20 MEMBER SONNABEND: Most of the 

21 additional ones that would come up would be like 

22 other substrate ingredients instead of rice, 
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1 barley and wheat. Maybe triticale, for instance. 

2 I mean, they're just like very routine type things.

3 If one came up that they really felt was 

4 problematic they could turn it in to the NOSB before 

5 they approved it.

6 They're under no obligation to approve 

7 one that is not on the list.

8 MEMBER OAKLEY: Could I follow up with 

9 a quick question? 

10 How many new ancillary substances do 

11 you anticipate the agencies having to review, or 

12 is that something you can't anticipate?

13 MEMBER SONNABEND: Maybe Scott has a 

14 better idea.

15 MEMBER RICE: I couldn't estimate a 

16 number, but I would say that with the criteria 

17 that's presented there was general agreement from 

18 the certifiers that this was a sensible way of 

19 moving forward barring looking at every -- running 

20 every single material through the petition 

21 process.

22 I had one other question, but I can --
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1 MEMBER SONNABEND: Well, let me just 

2 respond to Emily a bit first.

3 We did post this particular chart three 

4 times for three different meetings. Each time we 

5 got in one or two more things to add to the chart. 

6 But they were all in the -- I would say in the 

7 agricultural categories, not in the other -- just 

8 other things that could be substrates.

9 MEMBER AUSTIN: Scott and then Dan.

10 MEMBER RICE: There was a couple of 

11 comments from certifiers curious if the criteria 

12 from the 2013 proposal was being supplanted or 

13 amended.

14 MEMBER SONNABEND: And I tried to make 

15 that clear that the first set of criteria from the 

16 2013-14 proposal is what we the NOSB use when we're 

17 looking at the chart.

18 And then the other ones that are in this 

19 are for certifiers to use when they want to add 

20 things in the chart.

21 They're not that different, but there 

22 are a few minor differences.
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1 MEMBER RICE: Thanks.

2 MEMBER AUSTIN: Dan.

3 MEMBER SEITZ: So, as a new Board 

4 member like Emily this is somewhat over my head in 

5 terms of what effect this has.

6 My sense is that this tightens up 

7 overall our oversight over ancillary substances. 

8 But could you sort of explain that in a brief way 

9 how that tightens up oversight? If that's 

10 correct.

11 MEMBER SONNABEND: Okay. Well, 

12 members of the public have raised concerns over 

13 things like formaldehyde being included as a 

14 potential preservative.

15 Now, I don't even think formaldehyde is 

16 allowed to be used in food, period. But that's the 

17 type of concern that we're trying to dispel by 

18 taking a look at all the things that could possibly 

19 be in there.

20 Because as we all know the FDA allows 

21 a lot more things than we allow in organic. And 

22 so we feel like it's due diligence to take a look 
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1 at all of the things that are in there in case there 

2 are some that really start ringing bells that we 

3 really need to prohibit it.

4 MEMBER RICHARDSON: I think, too, Dan, 

5 what it does is it gives us a framework to be sure 

6 that there's less -- I mean, I'm not going to say 

7 we might find every ancillary. But this gives us 

8 a framework to ensure that we do the due diligence.

9 So I think it's a really good step 

10 forward to tighten up and get a structure so we're 

11 less likely to have something fall through the 

12 cracks.

13 MR. MCEVOY: This is Miles. Point of 

14 clarification. If you pass this recommendation 

15 then AMS will take a look at it to see how it would 

16 potentially be implemented. 

17 You were talking about certifiers doing 

18 things and it almost sounded like they would do 

19 those things immediately based on the 

20 recommendation.

21 Certifiers would not do that. The 

22 certifiers would only do that if there was some 
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1 rulemaking or instructions to certifiers to start 

2 to actually implement any recommendation that you 

3 passed.

4 So I just wanted to clarify the process 

5 here. There's a recommendation. Then there's 

6 that implementation part where AMS has to either 

7 do rulemaking to implement this or somehow 

8 instructing certifiers to start to conduct that 

9 review of ancillaries.

10 MEMBER SONNABEND: Although, Miles, 

11 right now certifiers do use the charts in the TRs 

12 to take a look at ancillary substances. That's not 

13 that big of a change from what they're already 

14 doing.

15 MR. MCEVOY: Well, they have to be 

16 evaluating the substances that they're using based 

17 on the current regulations and guidance and 

18 instructions that we provide, not on the NOSB 

19 recommendations unless they've been specifically 

20 adopted by the NOP.

21 For instance, for grower groups we've 

22 adopted the NOSB recommendations in instructions 
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1 to certifiers.

2 In this particular case if they're 

3 doing this review based on an NOSB recommendation 

4 without further instruction from the program 

5 that's not the correct procedure. They should not 

6 be doing that.

7 MEMBER SONNABEND: Well, isn't there 

8 some procedure right now for how they determine 

9 compliance? Because some of them even in fact 

10 prohibit certain things in ancillary substances 

11 already. So they must be doing that under the 

12 auspices of NOP.

13 MR. MCEVOY: No, they would be doing 

14 their reviews based on the regulations and guidance 

15 and instructions. So, the materials review 

16 process that they conduct is based on the 

17 regulations and the further instructions that 

18 we've provided to them in the handbook and through 

19 TR. This is not part of that.

20 MEMBER AUSTIN: Thank you for that 

21 clarification. Any further discussion? Emily.

22 MEMBER OAKLEY: This is just another 
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1 question. I'm still just confused as to how many 

2 new ancillary substances are anticipated to come 

3 up that certifying agents would have to review.

4 I mean, is this -- can somebody give me 

5 a general estimate? And how would those -- no.

6 MEMBER SONNABEND: Well, we can't 

7 because we've never tried tabulating them for all 

8 the types of products.

9 And it's quite different for the 

10 different types of products. Pectin, for 

11 instance, only had two things. It had dextrose or 

12 some other type of sugar and like citric acid, or 

13 the salt of citric acid for a standardizing agent.

14 There's probably zero chance that any 

15 additional ones would come in for pectin because 

16 it's just so always that way.

17 But you start looking at the vitamin and 

18 mineral formulations, and natural flavorings is 

19 another one that has lots and lots of ancillary 

20 substances. So there might be a lot because it 

21 would be very hard to capture them all at the first 

22 time you try. 
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1 But there are -- I mean, the reason we 

2 don't want to have to put each one on the National 

3 List is it's hundreds, hundreds of them.

4 MEMBER AUSTIN: Emily, this was one of 

5 the concerns that we all had when this first came 

6 up was what the scope of this might actually lead 

7 to and the time constraints that it might have 

8 actually on this Board.

9 And so this is one of our attempts to 

10 try to streamline the process as much as possible 

11 if we can.

12 One more question and then we need to 

13 move on I think. Go ahead.

14 MEMBER OAKLEY: So, as new substances 

15 come up will they be identified, tabulated, 

16 categorized? By whom, the Handling Subcommittee?

17 MEMBER AUSTIN: We're hoping that that 

18 information will be included in the petition and 

19 also in the TR. 

20 Harriet and then we probably need to 

21 move this to a vote.

22 MEMBER BEHAR: Very quick. This just 
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1 gives us transparency. This is what I think the 

2 original request from the public was, to have 

3 transparency. 

4 And so when we are reviewing items and 

5 when the certifiers are reviewing items that 

6 everyone knows what's in the product. And we're 

7 just going into it with our eyes open.

8 MEMBER AUSTIN: Thanks, Harriet. Any 

9 other questions? 

10 Okay, we do have a proposal that is a 

11 motion with a second from the subcommittee before 

12 us. 

13 That motion is to adopt the proposal as 

14 stated above for the definition, criteria for 

15 compliance and procedure for the review of 

16 ancillary substances. 

17 It's come from the subcommittee as a 

18 motion by Zea, seconded by Jean Richardson in front 

19 of us for a vote by the entire NOSB. I will turn 

20 it over to you, Tracy.

21 CHAIR FAVRE: Okay, we're going to 

22 start the vote with Jean.
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1 MEMBER RICHARDSON: Yes.

2 MEMBER BEHAR: Yes.

3 MEMBER SONNABEND: Yes.

4 MEMBER RICE: Yes.

5 MEMBER OAKLEY: Yes.

6 MEMBER THICKE: Yes.

7 MEMBER AUSTIN: Yes.

8 MEMBER BUIE: Yes.

9 MEMBER BECK: Yes.

10 MEMBER SWAFFAR: Yes.

11 MEMBER ROMERO-BRIONES: Yes.

12 MEMBER DE LIMA: Yes.

13 VICE CHAIR CHAPMAN: Yes.

14 MEMBER SEITZ: Yes.

15 CHAIR FAVRE: The chair votes yes.

16 MEMBER DE LIMA: Fifteen yes, zero no. 

17 The motion passes.

18 MEMBER AUSTIN: Moving forward to our 

19 last material in front of us today. It would be 

20 a discussion document on nutrient vitamins and 

21 minerals annotation change. Zea?

22 MEMBER SONNABEND: Okay, this will be 
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1 short because I'm sure people want to get to lunch. 

2 And this is just a discussion document so no action 

3 will be taken.

4 Well, those of you who were here in 

5 Vermont I had a little hissy fit over frustration 

6 that the department had not moved forward with all 

7 of the recommendations we made in 2012 and '13 about 

8 ingredients in infant formula, and even dating back 

9 as 2011 on DHA.

10 And how they got very bogged down by 

11 having a proposed rule that would have revised the 

12 listing somewhat that has not -- it has advanced 

13 to an interim final rule, but it has not advanced 

14 to a final final rule.

15 So, and there's a very long history 

16 which we have repeated. We shortened it for this 

17 one, but we had repeated it -- no, we didn't shorten 

18 it. I guess it's just as long. In the sunset 

19 review for this subject.

20 From the very beginning of the National 

21 List there was a mistaken citation to the CFR and 

22 we can't even get that corrected in 20 years of 
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1 doing this.

2 So I did feel like there's some need to 

3 continue to try and tackle the problem.

4 However, it's pretty clear that this is 

5 an issue that is not going to move forward 

6 satisfactorily because of it's all tied up with 

7 money and corporate influence, I guess.

8 And so I just put out this discussion 

9 document, or we the Handling Subcommittee to talk 

10 about some of our different preferred options for 

11 changing the listing.

12 We got a lot of public comment back. 

13 I'm not going to try and go into every single one 

14 of it because this clearly is going to need further 

15 work, but we got a lot of comment back concerning 

16 giving away our power to the FDA.

17 And that is something I absolutely 

18 reject because the citation given for the FDA 

19 standard identity is just that, it's a standard of 

20 identity. It's not giving them power over the 

21 National List in any way, shape, or form.

22 That being said, the alternative 
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1 proposal was to list each individual vitamin and 

2 mineral on the National List which was probably 

3 what would have been correct from the outset 

4 because listing groups is always a problem.

5 And unlike enzymes, for instance, where 

6 there's about 8 million of them there is a finite 

7 list of vitamins and minerals that are approved by 

8 the FDA, and a great many of the specific forms are 

9 already on the National List so this probably could 

10 be done and probably should have been done. But 

11 I'm not sure that it should be done going forward. 

12 I am not ready to go there myself. We'll see.

13 We got a lot of people who wanted to 

14 restrict the vitamins and minerals to those 

15 required by law, but didn't really like how 

16 complicated I made it, and didn't like the "made 

17 with organic" category.

18 And then we got a lot of people who 

19 supported just changing the terminology in the 

20 listing but still allowing all the vitamins and 

21 minerals for all food in all categories, but with 

22 the correct citation in there.
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1 It got pointed out to us that some 

2 problems with saying vitamins and minerals for food 

3 which we had thought was a good listing. But it 

4 does not include feed and it does not include 

5 dietary supplements.

6 And therefore, we have to be more clear 

7 about exactly what we're including and not 

8 including if we were to adopt such a change in 

9 terminology.

10 So, this is going back to subcommittee 

11 clearly. I'm nearing the end of my term on the NOSB 

12 and this is probably not what I'm going to work on 

13 any further because I have some important 

14 priorities of things to get done including coming 

15 forward hopefully with a BPA packaging discussion 

16 document for the next meeting.

17 And so maybe another subcommittee 

18 member will take this on and decide on what the next 

19 version of this would look like.

20 But in the meantime we're stuck. The 

21 interim final rule is not going to final anytime 

22 soon from what I hear. And we're not going to 
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1 remove the infant formula items that we voted off 

2 for the list without some extreme political 

3 pressure to do so.

4 So that's where it stands. And if 

5 anyone has questions I am happy to take them.

6 MEMBER AUSTIN: Questions for Zea? 

7 Harriet.

8 MEMBER BEHAR: There was a public 

9 comment I think from a few people that suggested 

10 when you cite the CFR that you also list the 

11 vitamins that are in the CFR. Okay.

12 MEMBER SONNABEND: I -- mention that 

13 and said that probably should have been done from 

14 the beginning. But whether we go back and redo it, 

15 I don't know. It's a possibility.

16 MEMBER AUSTIN: Tom.

17 VICE CHAIR CHAPMAN: I want to note too 

18 that we had a couple of comments about enteral 

19 feeding and that these proposals or these options 

20 didn't accommodate the enteral feeding needs.

21 And I noticed looking back over the old 

22 minutes of the individual nutrients that were 
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1 reviewed there was like some of them had -- the NOSB 

2 at that time added some annotation to those for 

3 enteral feeding. 

4 But I don't think the holistic look was 

5 done on the major vitamins and minerals listing. 

6 I don't know for certain. But that's definitely 

7 I think something that needs to be thought through.

8 MEMBER SONNABEND: We were told by the 

9 department that we could not put that annotation 

10 on.

11 VICE CHAIR CHAPMAN: Oh, really.

12 MEMBER SONNABEND: Yes. And I knew 

13 why at the time and I can't remember why now.

14 MEMBER AUSTIN: Emily.

15 MS. BROWN ROSEN: That had to do with 

16 a consultation with FDA on how they regulate 

17 enteral products. And they don't really recognize 

18 that as a class. It's more of like an individual 

19 approved product by FDA. So they did not want us 

20 to have that on the list.

21 They have come out with some new 

22 guidance on those products which I haven't really 
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1 looked at yet, but I will send that around and we 

2 can look at that further.

3 MEMBER AUSTIN: Thank you.

4 VICE CHAIR CHAPMAN: I'd appreciate 

5 that.

6 MEMBER AUSTIN: Any other questions or 

7 comments? All right. Thank you, Zea.

8 Tracy, that ends the presentation for 

9 today from the Handling Subcommittee to the NOSB.

10 CHAIR FAVRE: Thank you, Harold. 

11 Okay, we're running considerably behind schedule 

12 today. We are going to go ahead and take our lunch 

13 break now, but I'll ask you to be back instead of 

14 at 1:45 making it 1:30. We'll try to make up a few 

15 minutes then.

16 We will begin with crops immediately at 

17 1:30. Thank you. 

18 (Whereupon, the above-entitled matter 

19 went off the record at 12:30 p.m. and resumed at 

20 1:35 p.m.)

21 MEMBER SONNABEND: Okay, welcome to 

22 the Crops Subcommittee. We're going to start with 
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1 the 2018 sunset substances.

2 The first one up is copper sulfate which 

3 is mine which I'm pulling up right now.

4 DR. BRINES: Zea, would you like me to 

5 proceed with the introduction?

6 MEMBER SONNABEND: Oh yes, please.

7 DR. BRINES: There are two listings for 

8 copper sulfate that fall under the sunset 2018 

9 review. 

10 The substance is listed under Section 

11 205.601 of the National List as a synthetic 

12 substance allowed for use in organic crop 

13 production.

14 The two listings read as follows. 

15 Under paragraph A as algicide disinfectants and 

16 sanitizer including irrigation systems cleaning.

17 Number three, copper sulfate for use as 

18 an algicide in aquatic rice systems is limited to 

19 one application per field during any 24-month 

20 period.

21 Application rates are limited to those 

22 which do not increase baseline soil test values for 
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1 copper over a time frame agreed upon by the producer 

2 and accredited certifying agent.

3 The second listing appears under 

4 paragraph E as insecticides including acaricides 

5 or mite control.

6 As number four, copper sulfate for use 

7 as a tadpole shrimp control in aquatic rice 

8 production is limited to one application per field 

9 during any 24-month period.

10 Application rates are limited to levels 

11 which do not increase baseline soil test values for 

12 copper over a time frame agreed upon by the producer 

13 and accredited certifying agent. Thank you.

14 MEMBER SONNABEND: Okay. Copper 

15 sulfate has been an extensively reviewed material 

16 in the past both for disease control and for these 

17 two uses which are particular to rice production.

18 And I should say that they are 

19 particular to rice production in California as far 

20 as I know. At least the rest of the rice growing 

21 areas of the United States do not have the same 

22 weather conditions that lead to the need for this 
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1 material.

2 And I don't think most of the rest of 

3 the world does either.

4 I know quite a bit about this material 

5 because truthfully I was the original petitioner. 

6 Well, CCOF was the original petitioner and I wrote 

7 the petition. And on behalf of the many rice 

8 growers in California. 

9 At the time that it was first put on the 

10 list many rice growers were heard from. And in the 

11 time it was last reviewed which was immediately 

12 before I joined the Board many rice growers were 

13 heard from.

14 We asked for questions about new 

15 information concerning alternatives that were 

16 being looked at. And we asked for what producers 

17 were seeing in the increase in soil test values for 

18 copper.

19 We only received very few comments. 

20 And the very few comments did not give us specific 

21 data about their soil tests for copper, but all 

22 indicated that it wasn't a problem in terms of 
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1 buildup.

2 I haven't inspected rice in a few years, 

3 but I can say I've inspected a lot of rice in the 

4 past and we do look at soil tests and we do monitor 

5 the use of copper.

6 As far as viability of alternatives, 

7 during the last review when I was not on the Board 

8 but we submitted comments for CCOF and so the Board 

9 had access to the research material that we knew 

10 about.

11 And the California Rice Research 

12 Institute researches materials every year and I 

13 submitted their reports from I think it was 2010 

14 backwards, for four or five years backwards.

15 And they had looked at a few things 

16 including -- a few things that were organically 

17 acceptable including sodium carbonate, 

18 peroxyhydrate which was a 2015 sunset item, and 

19 maybe OxiDate. I can't remember all the things 

20 they researched. But none of them worked.

21 I have not scrutinized their report yet 

22 for this review but I will when we have the second 
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1 posting. This first posting was a call for the 

2 public to submit information primarily. 

3 But I strongly suspect because I talked 

4 to several rice growers in preparing for this 

5 review and they told me they were not aware of new 

6 research, and they get informed about that by the 

7 rice research board.

8 And those things just did not work. 

9 The sodium carbonate peroxyhydrate which we did a 

10 recent review of we had several of the growers write 

11 in and say that they had tried it and it just did 

12 not work for the situation.

13 Because we're running behind I don't 

14 want to go into a great level of detail on exactly 

15 how this is used, but it's used only occasionally 

16 when a certain set of weather conditions occur 

17 during the period between when the rice is seeded 

18 and the time it emerges from the water. 

19 So it's about a five- to seven-day 

20 period and if the weather is just so, like if it 

21 stays somewhat cold and therefore the water stays 

22 somewhat cold, and the scum disease, they call it 
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1 scum disease. It's an algae. But the rice is not 

2 able to emerge through the water because this thick 

3 scum forms on top of it.

4 And the same type but slightly 

5 different weather conditions lead to the tadpole 

6 shrimp getting out of control.

7 So, we did not receive new information 

8 about any alternatives. We will do a more complete 

9 review in the fall based on our own research and 

10 the limited amount that we did receive in public 

11 comment. Any questions? Harriet.

12 MEMBER BEHAR: So, I believe this is on 

13 our research priorities list? Or is it for 

14 different use?

15 MEMBER SONNABEND: Copper as a whole 

16 is. And it doesn't single out rice use of copper 

17 versus all the other uses of copper. But as a 

18 whole.

19 MEMBER BEHAR: So the scum production 

20 and the tadpole. There isn't a specific research 

21 action item to look at alternatives to copper for 

22 those uses?
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1 MEMBER SONNABEND: But it's included 

2 in the overall copper because we're not as specific 

3 in our research priorities. 

4 MEMBER RICHARDSON: Just a quick 

5 question to verify. So it looks like the intent 

6 of the Crops Subcommittee so far is that this should 

7 stay on the list.

8 MEMBER SONNABEND: Yes, we did not 

9 receive new information to that effect. Any 

10 other? Okay. 

11 Next is ozone gas. Lisa?

12 DR. BRINES: Thank you. This 

13 substance is included under Section 205.601 of the 

14 National List under paragraph A, number five, ozone 

15 gas for use as an irrigation system cleaner only. 

16 Thanks.

17 MEMBER THICKE: That's me, right?

18 MEMBER SONNABEND: I think so.

19 MEMBER THICKE: Okay. So, ozone was 

20 originally petitioned for use for wheat control. 

21 It was to be injected into irrigation tape under 

22 mulch.
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1 And then it was subsequently petitioned 

2 to be used to clean irrigation lines. And it's a 

3 strong oxidant. And it works by oxidizing plant 

4 tissue in bacterial membranes.

5 Well, in 2002 ozone was not approved for 

6 wheat control but only approved for irrigation 

7 system cleaning.

8 And again, at sunset in November 2007 

9 it was relisted by 14 to zero. At sunset in 2011 

10 it was relisted again by a vote of 13 to zero.

11 The Crops Subcommittee for the first 

12 round asked to see if it's used by producers. And 

13 we didn't get a lot of comments, but we did get 

14 enough to know that it's used by a fair number of 

15 producers.

16 And all of our comments were positive 

17 except that there was some concern about ozone 

18 being a strong oxidant that it can be not only an 

19 air pollutant but also can be hazardous to health.

20 But if used in an irrigation system 

21 properly it shouldn't have those problems.

22 So we didn't have any comments that 
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1 would indicate to us that we shouldn't relist it. 

2 So I don't know that we would be inclined to do that 

3 at this point.

4 Any comments or questions?

5 MEMBER RICHARDSON: I mean, the ozone 

6 gas is pretty serious for human health. I mean, 

7 if you're an asthmatic you don't want to be anywhere 

8 near that stuff.

9 And I mean, I use it for mold control 

10 in the basement because it's so darned effective. 

11 But as you say it's within an irrigation system so 

12 it should be okay.

13 But it would be good for you just to look 

14 to verify that they are not using it in such a manner 

15 that it could in fact escape because then it will 

16 definitely be a human health impact on the workers.

17 MEMBER THICKE: It could be with the 

18 workers if it weren't handled properly, that's 

19 right.

20 MEMBER SONNABEND: I don't see any 

21 other questions so we are ready to move on to 

22 peracetic acid. I believe that's Harold.
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1 DR. BRINES: Yes, and I'll go ahead and 

2 introduce it. Thank you.

3 There are two listings for peracetic 

4 acid under consideration for the sunset 2018 

5 review. 

6 The first listing appears at Section 

7 205.601(a)(6) and is listed as peracetic acid for 

8 use in disinfecting equipment, seed and asexually 

9 propagated planting material. Also permitted in 

10 hydrogen peroxide formulations as allowed in 

11 Section 205.601(a) at concentration of no more than 

12 6 percent as indicated on the pesticide product 

13 label.

14 The second listing occurs at Section 

15 205.601(I) as number eight, peracetic acid for use 

16 to control fire blight bacteria. Also permitted 

17 in hydrogen peroxide formulations as allowed in 

18 Section 205.601(I) at concentration of no more than 

19 6 percent as indicated on the pesticide product 

20 label. Thanks.

21 MEMBER AUSTIN: Thanks, Lisa. 

22 Peracetic acid is a pretty straightforward 
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1 material. It's made from and decomposes back to 

2 acetic acid, oxygen and water. 

3 It is a very strong oxidizing agent. 

4 This substance was first developed in 1950. 

5 Historically it's been used to treat fruits, 

6 vegetables to help reduce the spoilage from 

7 bacteria and various fungi.

8 As it was mentioned for crop production 

9 it's got several different uses as far as 

10 disinfecting equipment, seed, asexual propagated 

11 plant material.

12 It is allowed and permitted in hydrogen 

13 peroxide formulations that are to see a 

14 concentration of no more than 6 percent.

15 It's also used in fire blight control 

16 in tree fruit such as apples and pears.

17 One of the things I'll point out is that 

18 under a recommendation for the 2013 sunset review 

19 that took place in December of 2011 for this 

20 material under the two crop listings there was an 

21 annotation change adding the percentage, the 

22 recommended to permit hydrogen peroxide use in 
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1 formulations of concentrations of no more than 5 

2 percent.

3 That 5 percent recommendation was later 

4 changed to 6 percent when this was listed based off 

5 of information that was provided during public 

6 testimony via written and also oral testimony at 

7 that time. So I just wanted to add a little bit 

8 of clarification on that.

9 We did ask a question out to the 

10 stakeholder groups for public comment back if that 

11 change from 5 percent to 6 percent would have any 

12 cause for concern or issues that they could 

13 foresee.

14 Nobody thought that that was an issue. 

15 In fact, we got a couple that asked why do we even 

16 have the 5 percent as part of the annotation. But 

17 I just wanted to put a little clarification onto 

18 that.

19 We did get 29 specific written comments 

20 back, plus we had two comments on the webinar and 

21 multiple at the in-person testimony that we've 

22 heard this week.
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1 Those opposed, a couple of the advocacy 

2 groups raised concerns about the forms of peracetic 

3 acid that were allowed. This was due to the TR that 

4 we got back which I will mention we received after 

5 we had already submitted our meeting one posting 

6 material. So we had not yet had a chance to review 

7 the TR and put that additional information into the 

8 document which we will do for the fall meeting.

9 To address that concern though a little 

10 bit, part of the confusion there is due to the TR 

11 identifying the FDA sanitation solutions a number 

12 of which do contain peracetic acid in other 

13 chemicals.

14 This does not impact us under this 

15 current NOSB sunset review of this material that's 

16 currently underway because we are only reviewing 

17 peracetic acid as a single substance, and there is 

18 no restriction on the manufacturer source.

19 It should also be duly noted that not 

20 all of the FDA solutions are suitable for use in 

21 organic production for use in direct contact with 

22 the product.
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1 Those opposed were also calling for a 

2 TR as Harriet had mentioned previously on one of 

3 the other materials for a full review of all 

4 sanitizers and disinfectants by the NOP and the 

5 NOSB along with a use and/or allowed use 

6 assessment. 

7 Essentiality is also called into 

8 question since there are other alternatives. That 

9 was brought into play by one public interest group.

10 Those supporting the relisting were 

11 several farmers, two public interest groups, three 

12 handlers, one manufacturer, four trade 

13 associations, three consultants. Three of those 

14 provided in support of it. One remained neutral. 

15 But all of them provided information as well as five 

16 certifiers provided comment.

17 There were several comments provided by 

18 industry that also said that their members still 

19 rely on peracetic acid, it's still an important 

20 tool in their crop production, as a good 

21 alternative to chlorine and as a major component 

22 of hydrogen peroxide which is becoming more 
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1 important as a tool for use in fire blight control 

2 since we removed the antibiotics from use. 

3 So, it's actually gained -- it looks 

4 like from public comment the importance and 

5 reliance upon this material has actually increased 

6 during this current sunset review.

7 Another comment was it's a key 

8 component of pathogen control for food safety and 

9 thus ultimately provides ultimate customers food 

10 safety protection because of its high oxidizer 

11 characteristics.

12 Compared to the alternatives this is a 

13 very benign material. One certifier shows that it 

14 has 84 of their clients have it listed on their 

15 organic systems plan. I'll be clear that that does 

16 not specifically mean that they use it, but that 

17 they request the possibility to have that material 

18 available if and when they do in fact have to have 

19 the use of it. Because as we all know we need to 

20 declare that up front rather than after the fact.

21 In response to the 6 percent annotation 

22 like I said, that was pretty much mixed emotions 
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1 all over the place on that. We'll delve a little 

2 bit deeper into the weeds as we move forward on it 

3 this summer. 

4 That's all I have. Open it up for 

5 questions.

6 MEMBER BEHAR: Are there ancillary 

7 ingredients, do you know?

8 MEMBER AUSTIN: Not that I'm aware of. 

9 But I haven't had time to really sift too far into 

10 the new TR that we got back either. I don't believe 

11 there will be, but we'll find out.

12 Any other questions? Zea, back to you.

13 MEMBER SONNABEND: Okay, thank you, 

14 Harold. 

15 Next up, and I lost my place here, but 

16 it's the list 3 inerts. Lisa.

17 DR. BRINES: Thank you. This 

18 substance is included on the National List at 

19 Section 205.601(m) as synthetic inert ingredients 

20 as classified by the Environmental Protection 

21 Agency for use with non-synthetic substances or 

22 synthetic substances listed in this section and 
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1 used as an active pesticide ingredient in 

2 accordance with any limitations on the use of such 

3 substances.

4 Under paragraph (m)(2) EPA lists three 

5 inerts of unknown toxicity for use only in passive 

6 pheromone dispensers. Thanks.

7 MEMBER SONNABEND: Thank you. Once 

8 the recommendation that we passed for an annotation 

9 change for the list 4 listing gets published and 

10 becomes a final rule this listing will be 

11 superseded because under the new inerts 

12 terminology the lists are changing to the current 

13 way the FIFRA and the EPA refers to them.

14 So, the list 3 inerts in pheromone traps 

15 are specifically cited with a different -- Emily, 

16 help me here. What's the clause called, the number 

17 called to the EPA regulations? It's just a CFR 

18 section that has to do with the EPA -- I'm blanking 

19 on the word -- tolerance exemptions. 

20 Now, public comment. Relatively 

21 little public comment on this, but those who did 

22 comment mostly wanted a separate TR and a complete 
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1 review of these.

2 We did request one probably a year ago 

3 now we did request one. This affects as far as we 

4 know for sure three substances which are anti-UV 

5 compounds that stay in the body of the pheromone 

6 dispenser, in the plastic to keep the pheromone 

7 from all dissipating at once and breaking down in 

8 the light, and do not get out into the environment 

9 themselves, but just help regulate the pheromone.

10 There might be a fourth item that we 

11 have never seen by a petition, but those three items 

12 were petitioned a long time ago and we do have those 

13 petitions posted on the website if anyone wants to 

14 review them. So it wouldn't have been that hard 

15 since at least we have disclosure which we don't 

16 on many inerts to do a TR on them. 

17 However, that was not done by the 

18 department. I personally don't have concerns 

19 about these items. They are stationary and not 

20 released in the environment. 

21 And banning them would ban pheromones 

22 which is not something we want to do in my opinion.
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1 But in any event that is where we stand 

2 on this. So this sunset review has to be completed 

3 because the new annotation change may not be 

4 published on time before this would take into 

5 effect.

6 But once that goes into effect this will

7 be removed as a listing. 

8 Questions? Harriet.

9 MEMBER BEHAR: Is there a way to change 

10 the annotation to just list those three items, 

11 instead of just saying list 3? Can we actually be 

12 clearer about what we are -- is that a significant 

13 change in sunset?

14 MEMBER SONNABEND: That's a 

15 significant change. That would have to be a 

16 separate proposal for an annotation change, which 

17 if this is just going to be superseded shortly after 

18 doesn't make an awful lot of sense. But you could 

19 propose it, I suppose.

20 Okay. And then we have one more 

21 sunset, calcium chloride. Lisa.

22 DR. BRINES: Thank you. This 
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1 substance is included at Section 205.602 of the 

2 National List under Non-Synthetic Substances 

3 Prohibited for Use in Organic Crop Production.

4 It's listed under (c) as calcium 

5 chloride. Brine process is natural and prohibited 

6 for use except as a foliar spray to treat a 

7 physiological disorder associated with calcium 

8 uptake. Thanks.

9 MEMBER BECK: So, as Dr. Brines stated 

10 calcium chloride is listed at 205.602 as a 

11 non-synthetic substance prohibited for use in 

12 organic crop production.

13 And the annotation only allows use as 

14 a foliar spray to treat a physiological disorder 

15 associated with calcium uptake.

16 Calcium chloride continues to be 

17 inappropriate for direct soil application given 

18 its high chloride content and high solubility.

19 Various factors contribute to the 

20 inadequate uptake of calcium which necessitates 

21 its continued allowance as a foliar spray.

22 Written public comments supported the 
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1 relisting of calcium chloride.

2 The subcommittee did not ask any 

3 questions of the public and has no concerns 

4 regarding the continued listing of calcium 

5 chloride.

6 MEMBER SONNABEND: Questions? 

7 Comments? Okay. So, we will come back with 

8 proposals for all these at the fall meeting.

9 Now, we move on to the proposal for ash 

10 from manure burning. Lisa.

11 DR. BRINES: Thank you. This petition 

12 was submitted by EnergyWorks BioPower, LLC on 

13 August 22, 2014. 

14 The petition was subsequently updated 

15 on October 9, 2014.

16 It addresses the current listing of ash 

17 from manure burning on Section 205.602 of the 

18 National List, Non-Synthetic Substances 

19 Prohibited for Use in Organic Crop Production.

20 The current listing reads ash from 

21 manure burning. They're looking for an annotation 

22 change.
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1 In support of the review no technical 

2 report was requested and this is the first NOSB 

3 meeting for this agenda item. Thank you.

4 MEMBER BECK: In their petition 

5 EnergyWorks BioPower explained that their facility 

6 could extract greater than 30 tons of minerals from 

7 240 tons of egg-layer poultry manure daily using 

8 a staged thermochemical reactor.

9 Their petition annotation rationale 

10 included, one, a suggestion that the extraction of 

11 minerals by controlled combustion would preserve 

12 their non-synthetic nature, and two, would allow 

13 organic growers to derive increased value from 

14 manure as a nutrient resource.

15 Poultry manure is sourced from 

16 concentrated animal feeding operations.

17 The petitioner described benefits of 

18 annotation approval including, one, generation of 

19 renewable electricity, two, prevention of excess 

20 nutrients in the environment, and three, the 

21 increased development of similar commercial 

22 processing facilities throughout the U.S.
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1 Although these benefits could sound 

2 promising, utilizing burning as a method to recycle 

3 millions of pounds of excess poultry manure 

4 inadvertently supports the business of 

5 concentrated animal feeding operations by creating 

6 an organic industry demand for ash.

7 Ash from manure burning was originally 

8 placed on 205.602 based on its incompatibility with 

9 organic production.

10 Burning removes carbon and nitrogen 

11 from the final ash product and lessens its 

12 soil-building value.

13 Not only does the material fail OFPA 

14 criteria but also utilizing ash from manure burning 

15 in order to assist concentrated animal feeding 

16 operations in the reduction of environmental and 

17 human health contamination is not a compelling for 

18 consideration for addition to the National List.

19 Public commenters unanimously 

20 supported the subcommittee proposal to reject the 

21 petitioned annotation.

22 MEMBER SONNABEND: Comments? 
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1 Questions? Okay, so no discussion, it appears, 

2 but the motion is on the floor as it came from 

3 committee made by Carmela and seconded by Colehour 

4 before he left the Board.

5 CHAIR FAVRE: Okay, I believe we're 

6 going to start the vote with Harriet if I'm correct. 

7 Is that right? Aren't we starting the vote with 

8 Harriet?

9 MEMBER SONNABEND: I don't think 

10 there's any discussion.

11 CHAIR FAVRE: Okay. Ready to start 

12 the vote. We're starting with Harriet.

13 MEMBER BEHAR: I just wanted to say one 

14 thing, that I support not adding this to the 

15 National List. So it's a no. So the vote is no.

16 MEMBER SONNABEND: No.

17 MEMBER RICE: No.

18 MEMBER OAKLEY: No.

19 MEMBER THICKE: No.

20 MEMBER AUSTIN: No.

21 MEMBER BUIE: No.

22 MEMBER BECK: No.
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1 MEMBER SWAFFAR: No.

2 MEMBER ROMERO-BRIONES: No.

3 MEMBER DE LIMA: No.

4 VICE CHAIR CHAPMAN: No.

5 MEMBER SEITZ: No.

6 MEMBER RICHARDSON: No.

7 CHAIR FAVRE: The chair votes no.

8 MEMBER DE LIMA: Zero yes, 15 no. The 

9 motion fails.

10 MEMBER SONNABEND: Thank you. Next is 

11 petition material squid and squid byproducts. 

12 Lisa.

13 DR. BRINES: Thank you. The petition 

14 for squid and squid byproducts was submitted by 

15 Shoreside Organics, LLC, on April 28, 2015. There 

16 was an amendment to the petition made on October 

17 1, 2015, and both that petition and amendment are 

18 posted individually on the National Organic 

19 Program website.

20 The petition requests the addition of 

21 squid and squid byproducts to Section 205.601 of 

22 the National List as a fertilizer.
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1 In support of its review the Crops 

2 Subcommittee did request the development of a 

3 technical report, and that report was developed and 

4 posted on the NOP website in 2016.

5 This is the first meeting at which the 

6 petition for squid and squid byproducts has been 

7 taken up by the NOSB. Thanks.

8 MEMBER BECK: Okay. The petition from 

9 Shoreside Organics for the addition of squid and 

10 squid byproducts to the National List stated that 

11 52 percent of the total squid body weight is 

12 discarded as waste.

13 This waste is typically generated from 

14 calamari food processing.

15 The petitioner has identified an 

16 opportunity to divert this waste from landfills and 

17 utilize it as a fertilizer for use in organic 

18 production similar to how liquid fish products are 

19 currently utilized.

20 The Crops Subcommittee motion listing 

21 included squid and squid byproducts. The 

22 inclusion of squid in the motion was not intended 
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1 to allow the harvesting of whole squid for the sole 

2 purpose of manufacturing an organic fertilizer.

3 Both the subcommittee and the Shoreside 

4 Organics Company representative who provided 

5 in-person public comment included squid in the 

6 listing motion specifically to be inclusive of the 

7 occasional whole squid that could potentially make 

8 it into the squid byproduct processing line for 

9 various reasons including spoiled squid that was 

10 no longer suitable for human consumption, or due 

11 to an accidental or inadvertent whole squid that 

12 snuck in.

13 Despite our intentions to limit the 

14 motion to squid byproducts from food processing the 

15 majority of public commenter requested the removal 

16 of squid from the listing motion to ensure that 

17 whole squid would not be harvested solely for use 

18 in fertilizers.

19 These commenters indicated that they 

20 would support the listing motion if it was limited 

21 to squid byproducts.

22 Additionally, a few commenters raised 
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1 concerns about environmental harm, worker health 

2 and heavy metal contamination.

3 Note that U.S. fisheries for squid on 

4 both coasts are managed to keep harvests at a level 

5 that ensure future abundance and sustainable 

6 operation of the fishery.

7 Less information is known regarding 

8 international fisheries.

9 Despite this enforcement the Monterey 

10 Bay Aquarium Seafood Watch website does explain 

11 that the main fishing gear used in the shortfin and 

12 longfin squid fisheries in the U.S. Mid-Atlantic 

13 region is bottom trawl which results in the bycatch 

14 of a relatively low number of loggerhead sea 

15 turtles whose populations have been in decline over 

16 the last few years.

17 The category achieved was good 

18 alternative. 

19 With regards to worker health while the 

20 NOSB members are deeply concerned with worker 

21 rights, their protection falls under the purview 

22 of other governmental agencies and cannot be 
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1 required or enforced by the National Organic 

2 Program.

3 Lastly, heavy metal contamination is 

4 minimal. Note that the squid fertilizer heavy 

5 metal contamination analysis provided by Shoreside 

6 Organics demonstrated minute and lower heavy metal 

7 contamination levels when compared to similar 

8 organically approved fish-based products.

9 Because of the public's feedback we are 

10 proposing splitting the existing listing motion 

11 into two motions in order to vote down the motion 

12 for whole squid and to vote on the motion for squid 

13 byproducts.

14 MEMBER SONNABEND: Okay. So, are you 

15 proposing that as an amendment or a change to the 

16 motion that came forward? Is it a motion to 

17 divide?

18 VICE CHAIR CHAPMAN: It will be, but we 

19 have to do the classification first.

20 MEMBER SONNABEND: Okay, so we're 

21 going to vote classification first and then decide 

22 how to handle it.
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1 VICE CHAIR CHAPMAN: Yes, we can 

2 discuss. Vote classification, divide, and then 

3 vote on the two.

4 MEMBER SONNABEND: Okay. So, then the 

5 motion is on the table from subcommittee to 

6 classify squid and squid byproducts as synthetic. 

7 Motion by Carmela and seconded by me, Zea.

8 MS. BROWN ROSEN: Zea, we would 

9 appreciate it if you would put the whole annotation 

10 on there because it sounds like you're just 

11 classifying squid by themselves as synthetic. But 

12 it's really synthetic when it's -- pH adjusted with 

13 sulfuric citric or phosphoric acid. You need to 

14 put that in there too would be helpful.

15 MEMBER SONNABEND: Okay. It just 

16 doesn't say that in what came out of committee.

17 So, well then is it a change to the 

18 motion so we have to take it back?

19 MS. BROWN ROSEN: No, no, it's a 

20 non-substantive change.

21 VICE CHAIR CHAPMAN: I'll move to amend 

22 the classification motion to read squid and squid 
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1 byproducts pH adjusted with sulfuric, citric and 

2 phosphoric acid as synthetic.

3 MEMBER SONNABEND: Okay. So Carmela, 

4 do you accept the amendment?

5 MEMBER BECK: Yes.

6 MEMBER SONNABEND: And I, the second 

7 accept it. So is that all we have to do now to vote?

8 CHAIR FAVRE: We have to vote on the 

9 amendment.

10 MEMBER SONNABEND: Okay. So, we're 

11 going to vote -- are we roll calling it?

12 CHAIR FAVRE: Yes.

13 MEMBER SONNABEND: Okay. We'll vote

14 on the amendment now.

15 CHAIR FAVRE: Okay, so we're clear to 

16 everybody there's been an amendment to the 

17 classification motion to make it clear that we are 

18 saying that the byproducts include the pH 

19 adjustment chemicals which the motion was just 

20 read. So everybody's clear on that we're going to 

21 vote on that amended motion.

22 And then once that's voted on then we 
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1 have to vote on the main motion. Okay? Yes, 

2 Scott?

3 MEMBER RICE: Do we need to clarify the 

4 amount of acid used shall not exceed?

5 MEMBER SONNABEND: That's not part of 

6 the classification because any amount is -- it's 

7 part of the annotation for the motion.

8 CHAIR FAVRE: Yes, this is the 

9 classification motion just so everybody's clear, 

10 okay? I know it gets a little confusing.

11 All right, we'll start the vote with 

12 Zea.

13 MEMBER SONNABEND: Yes.

14 MEMBER RICE: Yes.

15 MEMBER OAKLEY: Yes.

16 MEMBER THICKE: Yes.

17 MEMBER AUSTIN: Yes.

18 MEMBER BUIE: Yes.

19 MEMBER BECK: Yes.

20 MEMBER SWAFFAR: Yes.

21 MEMBER ROMERO-BRIONES: Yes.

22 MEMBER DE LIMA: Yes.
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1 VICE CHAIR CHAPMAN: Yes.

2 MEMBER SEITZ: Yes.

3 MEMBER RICHARDSON: Yes.

4 MEMBER BEHAR: Yes.

5 CHAIR FAVRE: Sorry, the chair votes 

6 yes.

7 MEMBER DE LIMA: Fifteen yes, zero no. 

8 The motion passes.

9 MEMBER SONNABEND: So now are we going 

10 to entertain a different motion?

11 CHAIR FAVRE: Now we're voting on the 

12 motion itself. The classification motion.

13 MEMBER SONNABEND: We put that on the 

14 table then, the motion from subcommittee to list 

15 squid and --

16 CHAIR FAVRE: No, this is the 

17 classification. 

18 MEMBER SONNABEND: We just voted on the 

19 amendment, not on the --

20 CHAIR FAVRE: That's right. We voted 

21 on approving the rights of the Board to amend. 

22 It's like nested Russian dolls, a motion within a 
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1 motion.

2 So now we are voting on the motion 

3 itself for classification. The last vote was to 

4 approve the Board to allow the amendment to the 

5 classification motion if everybody followed that.

6 So, is everybody clear? We're voting 

7 on the motion for classification now as amended. 

8 Okay, we'll start the vote with Scott.

9 MEMBER RICE: Yes.

10 MEMBER OAKLEY: Yes.

11 MEMBER THICKE: Yes.

12 MEMBER AUSTIN: Yes.

13 MEMBER BUIE: Yes.

14 MEMBER BECK: Yes.

15 MEMBER SWAFFAR: Yes.

16 MEMBER ROMERO-BRIONES: Yes.

17 MEMBER DE LIMA: Yes.

18 VICE CHAIR CHAPMAN: Yes.

19 MEMBER SEITZ: Yes.

20 MEMBER RICHARDSON: Yes.

21 MEMBER BEHAR: Yes.

22 MEMBER SONNABEND: Yes.
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1 CHAIR FAVRE: The chair votes yes.

2 MEMBER DE LIMA: Fifteen yes, zero no. 

3 The motion passes.

4 MEMBER SONNABEND: Now what do we do?

5 CHAIR FAVRE: Now we have the listing 

6 motion.

7 VICE CHAIR CHAPMAN: Do we want to 

8 discuss? Or I can just make the motion to divide 

9 it.

10 MEMBER SONNABEND: Well, yes, I guess. 

11 Can we discuss before we put a motion on the floor 

12 though?

13 VICE CHAIR CHAPMAN: Yes. I mean, 

14 we're now at the listing motion. We can discuss 

15 the listing motion. We can divide it and then 

16 discuss.

17 MEMBER SONNABEND: Okay, so let's 

18 discuss the listing motion then. We'll take 

19 discussion. Tracy.

20 CHAIR FAVRE: I just want to make sure 

21 we're clear that if we take squid off as we heard 

22 in public testimony this week this would allow for 
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1 what I'll call as cold squid that might either for 

2 whatever reason end up in the byproducts pile 

3 because it's maybe been dropped on the floor, or 

4 it was too small, or it wasn't appropriate for human 

5 consumption.

6 He listed it with squid and squid 

7 byproducts because he was afraid that there would 

8 be an interpretation that if there were any whole 

9 squid he would be in violation and he didn't want 

10 that to happen. So I want to make sure we're clear 

11 on that.

12 MEMBER SONNABEND: Jean. And then 

13 I'll call on myself.

14 MEMBER RICHARDSON: I was impressed 

15 with his presentation in general that it's a great 

16 way to deal with the squid byproducts.

17 But for me I don't need to divide the 

18 motion, I'll vote against both of them. I don't 

19 -- once again we've got a product which we're adding 

20 to the National List at a time when it takes 

21 two-thirds to get it on and two-thirds to get it 

22 off. 
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1 And I really don't want to be part of 

2 fishing down the food web as an environmentalist 

3 as a consumer because I think once we start, as we 

4 all know, that when one type of fish is no longer 

5 plentiful fishermen just move on to the next 

6 species. We've seen it many times in our 

7 lifetimes.

8 So once there's no tuna, no cod or 

9 whatever it might be then we go down to the crabs, 

10 the sardines, et cetera.

11 And so this fishing down the food web 

12 has a negative impact on the lower level species 

13 which play an important role in all the other fish 

14 in that marine ecosystem as well as the sea animals 

15 and marine mammals that feed on them.

16 And so I don't mind whether you -- I'll 

17 vote against both.

18 MEMBER SONNABEND: I called on myself 

19 next so then I'll take Francis and then Tom. Or 

20 whoever had their hand up.

21 In answer to the question about is it 

22 clear that we only intend it to be squid that is 
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1 in the processing waste stream from processing and 

2 not any that is caught specifically for fertilizer 

3 use.

4 I think we can make that distinction in 

5 the cover sheet that goes with the recommendation 

6 that we understand there may be the occasional 

7 whole squid in the waste stream.

8 And I think that will be clear to the 

9 department then that squid byproducts from 

10 processing.

11 I mean, it's just like you process 

12 carrots and a whole carrot might slip through in 

13 your carrot hummus. It's no different than any 

14 other sort of food processing in that way.

15 So now Francis.

16 MEMBER THICKE: Two comments. First 

17 of all, I'm sympathetic to what Jean said. 

18 However, I'm not convinced that if you don't take 

19 care of the waste and dump it in a landfill that 

20 you're going to really reduce the squid fishing. 

21 So I'm going to -- although I'm sympathetic with 

22 what you're saying I'm going to vote the other way.
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1 The other thing though on the 

2 procedure. If we split it in two motions why don't 

3 we just amend it and take squid out. Because if 

4 we split it in two motions we vote down that you

5 can't use squid, then is that going to mean that 

6 if you get some squid in your byproducts you can't 

7 use it?

8 VICE CHAIR CHAPMAN: Yes, that's a good 

9 suggestion.

10 MEMBER THICKE: Can we just amend the 

11 motion and just take squid out and just have 

12 byproducts only?

13 VICE CHAIR CHAPMAN: I think so. Is 

14 that significant according to the program?

15 MEMBER SONNABEND: There was some 

16 concern that since that's not how it was petitioned 

17 that we would be changing the petition. 

18 So we had asked Emily actually to 

19 clarify that. And maybe the department still can, 

20 what the distinction is between just amending it 

21 versus splitting.

22 DR. BRINES: All right, I'll take a 
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1 stab at that one. 

2 I think the intent of the petitioner to 

3 include squid and squid byproducts, my 

4 understanding is the impact of the amendment that 

5 you're proposing would still allow everything that 

6 was requested by the petitioner in that the intent 

7 wasn't to harvest squid specifically for use as a 

8 fertilizer. 

9 So it doesn't seem like it would be a 

10 substantive change to the proposal given that you 

11 would still be allowing the product that the 

12 petitioner has requested. 

13 I'm looking to Emily or Miles for nods 

14 on that. Thank you.

15 VICE CHAIR CHAPMAN: So, I move to 

16 amend the listing motion to strike the words "squid 

17 and."

18 MEMBER AUSTIN: Second that.

19 MEMBER SONNABEND: Okay, so Tom moved 

20 and Harold seconded. And we have to ask if that's 

21 agreeable to the original motion makers, right? 

22 No, you don't have to do that? Okay.
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1 So, then we have to vote on the 

2 amendment, and then we vote on the listing.

3 VICE CHAIR CHAPMAN: Yes, you can 

4 discuss both the amendment and the listing still.

5 MEMBER SONNABEND: Okay. So is there 

6 any more discussion before we move to vote on the 

7 amendment? Harriet.

8 MEMBER BEHAR: So, Jean told me I was 

9 naive but I think that allowing the use of this 

10 byproduct would actually provide another income 

11 stream for producers that would maybe even lessen 

12 the harvest of squid because they'd be able to make 

13 a little bit more money.

14 MEMBER RICHARDSON: That's not a 

15 criteria.

16 MEMBER BEHAR: No, but the disposal of 

17 the squid byproducts into the ocean does have a 

18 negative effect on the marine environment. And so 

19 that's another reason why I support the byproducts 

20 being used in a more positive way.

21 MEMBER SONNABEND: And that is a 

22 criteria. Emily.
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1 MEMBER OAKLEY: I pushed for removing 

2 whole squid and just listing squid byproducts to 

3 try to address the concerns, but thanks to Jean's 

4 brave comments I actually feel that I'm in 

5 concurrence with Jean on this.

6 Because even though it's farmers like 

7 myself who would be likely to use this product I 

8 feel that we have many alternatives. 

9 And I don't want organic farmers to 

10 contribute to sea degradation.

11 MEMBER SONNABEND: Tracy and then I'm 

12 calling on myself. And Ashley, did you have your 

13 hand up? Lisa had her hand up.

14 CHAIR FAVRE: Okay, I initially 

15 intended to vote against this for the reasons that 

16 Jean had stated.

17 But after talking it over with some 

18 Board members and thinking it through a little bit 

19 I feel like the potential impact of dumping it in 

20 landfills or in the ocean has a pretty negative 

21 impact.

22 And I think closing the loop. It seems 
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1 to me if the byproduct is already made, and the 

2 waste stream already exists that not allowing it 

3 and so therefore potentially impacting the 

4 environment negatively because we don't allow it 

5 doesn't make a whole lot of sense.

6 And if you think about the way a 

7 forefather might have done it and a farmer out in 

8 the middle of nowhere and you had a squid wash up, 

9 they're not going to say oh, I've got to put this 

10 in the trash. They're going to stick it in their 

11 field somewhere.

12 So, maybe that is naive. She's nodding 

13 her head yes for those of you who can't see her.

14 But I feel like if we've got a resource 

15 it seems wasteful to not avail ourselves of it as 

16 long as we're not creating an additional or 

17 increasing the waste stream. 

18 And I don't think by allowing the 

19 byproducts themselves that is an incentive for 

20 anybody to go out and harvest squid.

21 If the squid was not being harvested 

22 already I would say let's not allow this, but it 
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1 is. So I'm going to vote in favor it. Sorry, 

2 Jean.

3 MEMBER SONNABEND: Lisa and me and then 

4 Ashley.

5 MEMBER DE LIMA: I'm voting against it. 

6 I'm with Jean and Emily. I just, I can't get my 

7 head wrapped around -- as soon as I saw that this 

8 was a petition I started looking through Monterey 

9 Bay.

10 And I know in the summary we talked 

11 about well managed fisheries and them being yellow 

12 rated by Monterey Bay. But that's just two 

13 fisheries that are domestic to the U.S.

14 All the other fisheries are just all 

15 other species of squid throughout the world are 

16 rated red. And those are for environmental 

17 concerns, not necessarily labor concerns.

18 And so every single one of these species 

19 that's fished, there's no green rated squid 

20 anywhere on the Monterey Bay reports that I've 

21 combed through. 

22 So I kind of understand the argument 
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1 that we're recycling this waste, but we're 

2 recycling waste from a byproduct of an industry 

3 that's environmentally not sound. So I can't vote 

4 for it.

5 MEMBER SONNABEND: Okay, I'm calling 

6 on myself next, then Ashley, then Tom.

7 I would just like to point out one of 

8 our other criteria which is the alternatives and 

9 the availability and effectiveness of 

10 alternatives. 

11 When we first put fish products on the 

12 National List almost all the fish was byproduct 

13 fish from processing for food.

14 But over time as fish became more and 

15 more widely used in animal feed, and more and more 

16 people went organic, and more fertilizer was needed 

17 the fish started getting caught for just the 

18 purpose of those other uses.

19 And by using the already waste resource 

20 of squid we are reducing the impact of overfishing 

21 on the same environment. So to me that is one of 

22 the criteria that would make me vote yes in favor 
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1 of the squid byproduct.

2 So Ashley was next and then Tom.

3 MEMBER SWAFFAR: So I too am concerned 

4 like Jean is of overfishing, but I think back to 

5 what the commenter said yesterday who was the 

6 petitioner is these people who are fishing --

7 whatever you call it. When they're squidding for 

8 human consumption they're getting a dollar plus a 

9 pound, but for fertilizer they would be getting 

10 pennies. So I don't see that they would actually 

11 be squidding just for fertilizer. I really don't 

12 think that's going to happen.

13 So I really think that this solves an 

14 environmental issue with byproducts going to the 

15 landfill or back into the ocean. So I think this 

16 is a good substance for organic farmers that we 

17 could be using.

18 MEMBER SONNABEND: Tom was next, then 

19 A-dae.

20 VICE CHAIR CHAPMAN: My comments 

21 somewhat follow what Zea said, but I just wanted 

22 to remind the Board that we did just relist liquid 
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1 fish products which have all the same environmental 

2 issues here by a vote of 14 to 1.

3 So just keep that in mind if you're on 

4 the Board when liquid fish products come back up 

5 on the list. But consistency in how we interpret 

6 these things I think is important.

7 MEMBER SONNABEND: A-dae and then 

8 Lisa.

9 MEMBER ROMERO-BRIONES: So, I come 

10 from -- I love on an island where the majority of 

11 the population are sustainable fishermen or 

12 hunters. 

13 And we've seen this time and time again. 

14 When you create an economy for a certain product 

15 from the ocean it inevitably changes the way that 

16 resource is viewed within the community that has 

17 used it over generations upon generations.

18 So, on one hand I understand the need 

19 to create economic incentives for fishermen like 

20 those of Lanai, but on the other hand there's a need 

21 to protect that community that includes the 

22 fishermen and those resources that come from the 
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1 ocean.

2 And that weighs more heavily on my heart 

3 than anything. So I would vote against this.

4 MEMBER DE LIMA: Just to Tom's point 

5 about consistency, I mean I would just point out 

6 that when we voted the fish materials to relist them 

7 that was a sunset material and this is a petitioned 

8 material. 

9 And so, I don't have any problem with 

10 not voting for this. It's not a consistency issue 

11 for me because we're adding to the problem. 

12 Because I think the fish use is problematic too. 

13 I just don't want to add to that.

14 MEMBER SONNABEND: So I think we're 

15 ready to move to vote on the amendment first and 

16 then on the motion.

17 CHAIR FAVRE: Right.

18 VICE CHAIR CHAPMAN: Yes, the vote on 

19 the amendment which is to strike the words "and 

20 squid."

21 MEMBER SONNABEND: Should I read the --

22 VICE CHAIR CHAPMAN: It's to vote on 
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1 the amendment which strikes the words "squid and."

2 MEMBER SONNABEND: Should we read the 

3 whole thing without it? Or we will before we have 

4 the next vote. 

5 CHAIR FAVRE: Okay, so is everybody 

6 clear? We're doing the machinations like last 

7 time. We're amending the motion. We're voting on 

8 whether we can amend the motion first. 

9 So the motion before the Board is are 

10 you in agreement with striking "squid and" from the 

11 listing motion. 

12 MEMBER SONNABEND: Well, can I just --

13 CHAIR FAVRE: Yes, go ahead.

14 MEMBER SONNABEND: Those of you who are 

15 opposed to this, if you don't for this amendment 

16 and the rest of it goes through you're shooting 

17 yourself in the foot. So you would want to vote 

18 for this amendment and then against the second 

19 motion.

20 CHAIR FAVRE: That's right. All 

21 right, just so we're clear. All right, so we're 

22 going to start the vote with Emily.
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1 MEMBER OAKLEY: Yes.

2 MEMBER THICKE: Yes.

3 MEMBER AUSTIN: Yes.

4 MEMBER BUIE: Yes.

5 MEMBER BECK: Yes.

6 MEMBER SWAFFAR: Yes.

7 MEMBER ROMERO-BRIONES: Yes.

8 MEMBER DE LIMA: Yes.

9 VICE CHAIR CHAPMAN: Yes.

10 MEMBER SEITZ: Yes.

11 MEMBER RICHARDSON: Yes.

12 MEMBER BEHAR: Yes.

13 MEMBER SONNABEND: Yes.

14 MEMBER RICE: Yes.

15 CHAIR FAVRE: The chair votes yes.

16 MEMBER DE LIMA: Fifteen yes, zero no. 

17 The motion passes.

18 CHAIR FAVRE: Okay.

19 MEMBER SONNABEND: So the motion that 

20 we are voting on now is to list squid byproducts 

21 at 205.601(j) of the National List with the 

22 annotation can be pH adjusted with sulfuric, citric 
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1 or phosphoric acid.

2 The amount of acid used shall not exceed 

3 the minimum needed to lower the pH to 3.5. 

4 And that was moved -- well, which first 

5 and second stands for the motion? Out of 

6 subcommittee? Moved by Carmela and seconded by 

7 myself, Zea.

8 CHAIR FAVRE: Okay. So now we're 

9 voting on the amended motion to list. And we're 

10 going to start with Francis.

11 MEMBER THICKE: Yes.

12 MEMBER AUSTIN: Yes.

13 MEMBER BUIE: Yes.

14 MEMBER BECK: Yes.

15 MEMBER SWAFFAR: Yes.

16 MEMBER ROMERO-BRIONES: No.

17 MEMBER DE LIMA: No.

18 CHAIR FAVRE: Yes.

19 VICE CHAIR CHAPMAN: Yes.

20 MEMBER SEITZ: Yes.

21 MEMBER RICHARDSON: No.

22 MEMBER BEHAR: Yes.
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1 MEMBER SONNABEND: Yes.

2 MEMBER RICE: Yes.

3 MEMBER OAKLEY: No.

4 MEMBER DE LIMA: That's 11 yes, 4 no. 

5 The motion passes.

6 MEMBER SONNABEND: Thank you. Now 

7 we're moving onto hypochlorous acid. Lisa.

8 DR. BRINES: Thank you. The petition 

9 for hypochlorous acid is the same information that 

10 was read earlier into the record this morning.

11 So at this point we'll be considering 

12 the motion to add it to Section 205.601 of the 

13 National List for crop production uses. Thank 

14 you.

15 MEMBER SONNABEND: Harold.

16 MEMBER AUSTIN: Okay. This is the 

17 third of the three proposed listings throughout the 

18 subcommittees for hypochlorous acid.

19 For this particular use for the Crops 

20 Subcommittee the material was petitioned for use 

21 as a post-harvest sanitizer for use on raw herbs 

22 and spice materials no less than 60 parts per 
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1 million and as an equipment and cold room sanitizer 

2 at less than 200 ppm.

3 I think that's probably all we really 

4 need to go over on this at this point. If there's 

5 any questions. Zea?

6 MEMBER SONNABEND: Well, I just wonder 

7 about the value of having to have votes to classify 

8 it as synthetic in all the committees. It seems 

9 like once is enough but we have to. Twice so far, 

10 but all right.

11 MEMBER AUSTIN: Okay. Before we go 

12 into the voting I would make one clarifying point 

13 though is that we did hear comments back of another 

14 use by producers for electrolyzed water that 

15 they've been using in conventional farming for 

16 mildew control and other disease and pathogen 

17 control.

18 And that would be a use, an application 

19 that's outside of the scope of our review because 

20 that was not in the original petition as we're 

21 reviewing it right now.

22 So if they wanted that additional use 
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1 we would have to bring that forward as a different 

2 consideration. Is that correct?

3 Okay. So I just wanted to put that into 

4 the record so that they understand that that 

5 additional use would have to come from -- they would 

6 have to petition us for that use. Francis.

7 MEMBER THICKE: But if you look at the 

8 listing it just says as an algicide disinfectant 

9 and sanitizer. Would that disallow that if 

10 they're going to sanitize surfaces? For cleaning.

11 MEMBER AUSTIN: Yes, because it would 

12 be being used as a pesticide because it would be 

13 fungicidal control. It would actually physically 

14 be applied to the tree.

15 MEMBER THICKE: Oh, I misunderstood 

16 you. Okay.

17 MEMBER AUSTIN: Okay. So, listing. 

18 We have a motion in front of the entire Board from 

19 the subcommittee to list this, classify this 

20 hypochlorous acid as a synthetic.

21 It came as a motion from the 

22 subcommittee by myself and seconded by Francis.
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1 CHAIR FAVRE: Okay, this is the 

2 classification motion and we will start the vote 

3 with Harold.

4 MEMBER AUSTIN: Yes.

5 MEMBER BUIE: Yes.

6 MEMBER BECK: Yes.

7 MEMBER SWAFFAR: Yes.

8 MEMBER ROMERO-BRIONES: Yes.

9 MEMBER DE LIMA: Yes.

10 VICE CHAIR CHAPMAN: Yes.

11 MEMBER SEITZ: Yes.

12 MEMBER RICHARDSON: Yes.

13 MEMBER BEHAR: Yes.

14 MEMBER SONNABEND: Yes.

15 MEMBER RICE: Yes.

16 MEMBER OAKLEY: Yes.

17 MEMBER THICKE: Yes.

18 CHAIR FAVRE: The chair votes yes.

19 MEMBER DE LIMA: Fifteen yes, zero no. 

20 The motion passes.

21 MEMBER AUSTIN: Okay, so now for the 

22 listing motion. Tom?
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1 VICE CHAIR CHAPMAN: It's preferable 

2 to have a listing motion that's the same across all 

3 the subcommittees. And to be explicit the 

4 petition subcommittee review and the technical 

5 review were all for hypochlorous acid generated via 

6 electrolyzed water.

7 Therefore I move to amend the petition 

8 to read hypochlorous acid generated via 

9 electrolyzed water as petitioned.

10 MEMBER AUSTIN: Second that. 

11 CHAIR FAVRE: Okay, we have a motion 

12 and a second. I guess is there any discussion on 

13 that beforehand?

14 Okay, we'll begin the voting with 

15 Jesse.

16 MEMBER BUIE: Yes.

17 MEMBER BECK: Yes.

18 MEMBER SWAFFAR: Yes.

19 MEMBER ROMERO-BRIONES: Yes.

20 MEMBER DE LIMA: Yes.

21 VICE CHAIR CHAPMAN: Yes.

22 MEMBER SEITZ: Yes.
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1 MEMBER RICHARDSON: Yes.

2 MEMBER BEHAR: Yes.

3 MEMBER SONNABEND: Yes.

4 MEMBER RICE: Yes.

5 MEMBER OAKLEY: Yes.

6 MEMBER THICKE: Yes.

7 MEMBER AUSTIN: Yes.

8 CHAIR FAVRE: The chair votes yes.

9 MEMBER DE LIMA: Fifteen yes, zero no. 

10 The motion passes.

11 MEMBER SONNABEND: Okay, next up is soy 

12 wax. Lisa.

13 MEMBER AUSTIN: That was just a motion 

14 to amend. We still have the full motion to vote 

15 on.

16 CHAIR FAVRE: Okay. Now we have 

17 approved the right to amend the listing motion. So 

18 now we're voting on the main motion. Is there any 

19 discussion?

20 Okay, we will begin the vote with 

21 Carmela.

22 MEMBER BECK: Yes.
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1 MEMBER SWAFFAR: Yes.

2 MEMBER ROMERO-BRIONES: Yes.

3 MEMBER DE LIMA: Yes.

4 VICE CHAIR CHAPMAN: Yes.

5 MEMBER SEITZ: Yes.

6 MEMBER RICHARDSON: Yes.

7 MEMBER BEHAR: Yes.

8 MEMBER SONNABEND: Yes.

9 MEMBER RICE: Yes.

10 MEMBER OAKLEY: Yes.

11 MEMBER THICKE: Yes.

12 MEMBER AUSTIN: Yes.

13 MEMBER BUIE: Yes.

14 CHAIR FAVRE: The chair votes yes.

15 MEMBER DE LIMA: Fifteen yes, zero no. 

16 The motion passes.

17 MEMBER SONNABEND: Okay, now soy wax. 

18 Lisa.

19 DR. BRINES: Thank you. The petition 

20 for soy wax was submitted on September 30, 2015, 

21 by Beyond Pesticides.

22 The petition requests the addition of 
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1 soy wax to Section 205.601 of the National List for 

2 use in mushroom production.

3 There was no technical evaluation 

4 report completed for this petition substance and 

5 this is the first meeting where the petition is on 

6 the NOSB agenda. Thank you.

7 MEMBER THICKE: So, soy wax is intended 

8 to be used for the same purpose that now 

9 microcrystalline cheese wax is used for, and that's 

10 made from petroleum so this would be a more natural 

11 product.

12 It's made to plug the seal plugs and 

13 ends of logs where mushrooms are grown on.

14 Of course since it's made from a natural 

15 product it should be much more environmentally 

16 sound.

17 However, it is synthetic because it has 

18 to be hydrogenated. And so even if you had organic 

19 soybeans it still would be a synthetic product.

20 And so we made the annotation say that 

21 it has to be from non-GMO soybeans because even 

22 though it's an excluded method, GMOs, we wanted to 
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1 put it in there anyhow. And we got comments that 

2 people thought that was a good idea.

3 Other comments. We got comments, one 

4 from a farmer saying that he preferred to have a 

5 non-petroleum based product. We didn't get 

6 anybody against it that I saw.

7 However, we heard that it seems that 

8 some of the mushroom producers are going away from 

9 using logs now and are using more sawdust and wood

10 shavings. So maybe that would be phased out. 

11 Although they said some of the smaller producers 

12 are still using logs.

13 I think that about covers everything 

14 that I had to say. Any questions or comments?

15 MEMBER SONNABEND: There is an 

16 inconsistency, and I shouldn't have even let this 

17 go in, but if you actually look at the document 

18 under the listing motion it says "must be made from 

19 non-GMO soybeans," but then below it under proposed 

20 annotation, "must be made from non-GMO soybean oil" 

21 and those are not really the same thing.

22 MEMBER THICKE: It should be soybeans 
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1 on the bottom.

2 MEMBER SONNABEND: And it did confuse 

3 some of the commenters I noticed. 

4 So, we're voting on the motion the way 

5 it is listed, the way it is here in the first thing, 

6 but then we're going to change what it says there 

7 below. Tom.

8 VICE CHAIR CHAPMAN: Two questions. I 

9 was curious to know why a TR wasn't commissioned 

10 on this substance.

11 And then secondly, do we need a 

12 definition of non-GMO?

13 MEMBER THICKE: I'll answer the first 

14 one but not the second one.

15 Well, we felt that there was -- we 

16 didn't see any negative consequences from using 

17 something more natural. So we didn't see any need 

18 to go out and get a TR, to have the expense of a 

19 TR. 

20 I couldn't see that there were 

21 unanswered questions. Do you have some in mind?

22 VICE CHAIR CHAPMAN: I mean, not in 
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1 particular if the committee is satisfied with 

2 transparency into the manufacturing of this 

3 substance.

4 MEMBER THICKE: Yes, we felt that going 

5 from a petroleum-based product to a natural 

6 plant-based product was a good step, and didn't see 

7 any drawbacks to it.

8 VICE CHAIR CHAPMAN: Yes. I guess my 

9 question's around -- I understand that argument. 

10 That's clear and makes perfect sense.

11 I guess my question is did we fully 

12 evaluate the manufacturing of this substance 

13 though to make sure that we fully understand it and 

14 that there's no issues with this substance.

15 MEMBER THICKE: Well, it's basically 

16 hydrogenated which is kind of a common process. 

17 And so that's all that we went in looking at it.

18 MEMBER SONNABEND: The petition was 

19 complete enough in the manufacturing process.

20 VICE CHAIR CHAPMAN: Okay.

21 MEMBER THICKE: That's right. Thank 

22 you, Zea.
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1 MEMBER BEHAR: I think we need more of 

2 a definition on what non-GMO soybean oil is rather 

3 than what is non-GMO soybeans.

4 MEMBER SONNABEND: Why? Soybean oil 

5 is not in the definition.

6 MEMBER BEHAR: Oh, I thought you were 

7 going to do that later. Oh, so that proposed 

8 annotation is not going to be even voted on or 

9 anything. 

10 Okay, great. Because I know what 

11 non-GMO soybeans are, but not what non-GMO soybean 

12 oil is.

13 MEMBER SONNABEND: I'm going to just 

14 call on myself for a second. We have a proposed 

15 definition for non-GMO in the excluded methods 

16 terminology. And by the time this got turned into 

17 a rule that will be voted on in the fall. Which 

18 means it won't be a rule either, but that's probably 

19 as good as we're going to get.

20 Okay. So, Tom? Oh, the NOP is waving 

21 at us so let's let them go first.

22 DR. BRINES: Thank you, Zea. Just to 
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1 follow up on Tom's question regarding whether we 

2 need to define the term "non-GMO." 

3 I just want to remind the Board that 

4 they did have a similar intent with a previous 

5 recommendation on biodegradable biobased mulch 

6 film where the intent was to exclude feedstocks 

7 that were derived from GMO sources. So that was 

8 implemented that it must be produced without 

9 organisms or feedstocks derived from excluded 

10 methods. So for consistency with the rule that's 

11 usually the terminology we would implement.

12 I think the intent is clear from the 

13 proposal.

14 MEMBER SONNABEND: And that would not 

15 be a substantive change if we wanted to change that 

16 language now?

17 DR. BRINES: For purpose of 

18 interpretation of what your intent is I think it's 

19 clear either way. How that gets implemented in the 

20 regulatory language --

21 MEMBER SONNABEND: So you don't feel 

22 like it has to be changed to excluded methods, that 
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1 if we say this it's clear? That it's an excluded 

2 method.

3 Okay, we'll proceed with Tom.

4 VICE CHAIR CHAPMAN: That was 

5 basically what I was going to ask, if it would make 

6 more sense to say must be made not utilizing 

7 excluded methods or whatever. Using the line we 

8 already have.

9 MEMBER DE LIMA: This might be a silly 

10 question. Why do we have to put the GMO part in 

11 there? Isn't it implied? I don't understand.

12 MEMBER SONNABEND: Francis.

13 MEMBER THICKE: We don't have to and we 

14 discussed that. Because it's an excluded method 

15 we didn't have to, but we put it in there just 

16 because. 

17 Sometimes people, you know, they have 

18 to know that it's an excluded method. This way we 

19 make it clear.

20 And so I can understand which first, 

21 chicken and egg thing, you know. It's really GMOs 

22 that are excluded methods and so we thought non-GMO 
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1 would be a more clear statement.

2 It isn't necessarily needed, but 

3 actually the commenter, a lot of people who 

4 commented thought it was a good idea as well to 

5 reiterate that.

6 MEMBER SONNABEND: Okay, so Harriet, 

7 then Tracy.

8 MEMBER BEHAR: So based on the biobased 

9 biodegradable plastic mulch should we state 100 

10 percent non-GMO soybeans?

11 MEMBER SONNABEND: Are you proposing 

12 that as an unfriendly amendment?

13 MEMBER BEHAR: I don't know if it's 

14 unfriendly. I just know that there has been a need 

15 for clarification or discussion because it seems 

16 like what happened with the biodegradable mulch was 

17 that there seems to be confusion about how much of 

18 a percentage needed to be --

19 MEMBER SONNABEND: But that's not GMO. 

20 That's --

21 MEMBER BEHAR: I know, but I'm just 

22 wondering when you read this could it be just 5 
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1 percent non-GMO soybeans and that would still be 

2 okay? Or is our intention that all the soy wax must 

3 be from all non-GMO soybeans?

4 CHAIR FAVRE: Okay, so I think, 

5 Harriet, the confusion is the percent of biobased 

6 in the bioplastic mulch is where the percentage 

7 came in, not the percentage that was non-GMO first 

8 of all. That's my first point.

9 Second point is I hate to say this 

10 because I appreciate what the intent is, but it is 

11 a little bit in my opinion sloppy to have to include 

12 non-GMO in the annotation.

13 Because if we start that every single 

14 thing that is questionable we'd have to put from 

15 non-GMO sources. And that's redundant. 

16 It's also confusing because it does 

17 sort of imply if we specify it here but we don't 

18 specify it elsewhere that it somehow might be 

19 allowed when we've already been battling the issue 

20 that organic is non-GMO but there's some that are 

21 not clear on that.

22 And I think that might be fostering that 
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1 perception if we're not careful.

2 I would prefer to see it stricken from 

3 the annotation for that reason when we have 

4 overarching regulations that specify excluded 

5 methods are not allowed.

6 I think that's cleaner and I think 

7 that's a little bit tighter way to handle this.

8 MEMBER SONNABEND: I'm going to call on 

9 myself and then Harriet.

10 We purposely put it in the 

11 biodegradable mulch to be non-GMO for a couple of 

12 reasons.

13 One, it's a whole different product 

14 category for a different use and so we thought it 

15 was worth reemphasizing.

16 And two is in the absence of very 

17 completely clear guidance in how far back in the 

18 chain of foodstuffs or inputs you look for GMOs and 

19 some certifiers and for instance OMRI used decision 

20 tree structures which tend to say that some of the 

21 soil-based inputs if they don't have an expression 

22 of a GMO would be allowed.
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1 And so we wanted to make extra clear for 

2 this new category and soil-based applied thing that 

3 it was GMO.

4 I do not feel it's necessary here 

5 either. I didn't really want to have a big 

6 argument in the subcommittee that would look like 

7 we were in favor of GMOs if we voted that part out 

8 so we didn't pursue it.

9 Harriet was next, then Tracy.

10 MEMBER BEHAR: So it's specifically 

11 for that reason that various groups view -- so if 

12 it's a soybean oil it doesn't have the protein. 

13 And so if you go all over the internet it says 

14 non-GMO soy wax, but it actually is derived from 

15 GMO soybeans, but they're calling it non-GMO soy 

16 oil because the protein is not present in the final 

17 oil.

18 So I think that's why the committee then 

19 said to not derive it from GMO soybeans.

20 MEMBER SONNABEND: We realize that no 

21 products on the market meet this right now, right?

22 MEMBER THICKE: That's a good thing, 
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1 Harriet, that's why we did it. Because if it just 

2 said from -- if it didn't say it then you could have 

3 GMO soy oil because there aren't any GMOs in the 

4 soy oil. That I think was our reasoning.

5 MEMBER SONNABEND: Tracy?

6 CHAIR FAVRE: I was actually going to 

7 ask Francis, you made the statement earlier in this 

8 discussion that you didn't feel like it absolutely 

9 had to be in there, the statement about non-GMO. 

10 And I'm sort of asking if that still 

11 holds in your mind.

12 MEMBER THICKE: Well, I think now after 

13 I remember why we did that. Because you could have 

14 oil derived from GMO soybeans and it would be 

15 non-GMO oil. 

16 Because there's no protein in there. 

17 It's just oil, it's just a lipid. It's just an oil. 

18 So there's no GMOs in the oil.

19 MEMBER SONNABEND: But that doesn't 

20 matter. In our existing construct of excluded 

21 methods it doesn't matter if you detect it in the 

22 final product or not. It's a process-based 
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1 approach. 

2 And so in no case would an oil made from 

3 a GMO soybean be allowed in food production except 

4 if it was in a soil-applied thing according to OMRI 

5 which has never been officially adopted here.

6 MR. MCEVOY: I would say based on this 

7 discussion it would be very good to clarify that 

8 the soy wax is made from non-GMO soybeans.

9 Because you're talking about 

10 interpretations and this would make it very, very 

11 clear. From an enforcement perspective, from a 

12 certifier perspective we want the standards to be 

13 very, very clear. The way it's written currently 

14 is clear.

15 MEMBER SONNABEND: Okay, I think Jean 

16 is next and then Tom.

17 MEMBER RICHARDSON: But we use the word 

18 "excluded methods." I mean GMO isn't what we've 

19 been using.

20 I mean, I understand where you're 

21 coming from, Miles. I mean, I would agree with 

22 Tracy's initial comment there is that what we have 
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1 in our books that we're working on is the phrase 

2 "excluded methods." We don't use the word GMO.

3 VICE CHAIR CHAPMAN: I want to pile on 

4 that one real quick.

5 When you say it makes it more clear are 

6 you looking only at the context of this listing? 

7 Does it potentially make the rest of the listings 

8 that don't say non-GMO less clear then in that case?

9 MR. MCEVOY: Yes, it makes this listing 

10 clear. The rest of the listings as Zea mentioned 

11 certifiers are using OMRI's decision tree for the 

12 most part and that goes back in different depths 

13 in terms of how far back in the chain you go. 

14 So that's sort of a separate topic that 

15 probably this Board should take a look at, look at 

16 that decision tree, how far back do you go to 

17 clarify how far back you go with the non-use of 

18 excluded methods.

19 So, what we're saying is that non-GMO 

20 to us means excluded methods.

21 MEMBER SONNABEND: Miles, you wouldn't 

22 be adverse to say must be made from soybeans that 
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1 were not produced with excluded methods?

2 MR. MCEVOY: No, we wouldn't. We 

3 would not. That would be clear as well.

4 MEMBER SONNABEND: Harriet.

5 MEMBER BEHAR: So I support this with 

6 what we just mentioned. Because as an organic 

7 inspector I visited many shiitake mushroom log 

8 producing operations and saw piles where logs have 

9 decomposed into the ground, and piles of petroleum 

10 cheese wax laying there where the wildlife could 

11 eat it, where it was not decomposing.

12 And so seeing all of that I really would 

13 like to have some type of biodegradable option for 

14 those growers just so that wax which is going to 

15 take decades or longer to decompose in the 

16 environment would instead be something that would 

17 rather than something that's not.

18 I realize they're both on the National 

19 List now, but at some point if we had this and it 

20 was truly an option, if we had -- so then the 

21 question is also are we replacing a petroleum-based 

22 product with then an excluded methods produced 
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1 product. And that's why we decided to write it 

2 this way.

3 MEMBER RICE: I was going to bring up 

4 the OMRI decision tree prior to when it got out 

5 there.

6 But I think -- I would agree with some 

7 of the hesitation of including the non-GMO language 

8 or the excluded method language as it would point 

9 to a question mark around the things that aren't 

10 indicated as such.

11 With all due respect to the concern to 

12 keep GMOs out I think from a certification 

13 perspective we're using the decision tree and those 

14 would be -- the excluded would be excluded.

15 CHAIR FAVRE: So, are you supportive of 

16 removing the excluded language altogether? Is 

17 that what you're saying?

18 MEMBER RICE: It would seem by leaving 

19 it in it would point to the question mark around 

20 it not being in other areas.

21 MEMBER SONNABEND: Harold.

22 MEMBER AUSTIN: I would agree with the 
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1 comments that Scott just made.

2 I think it's trending us down a path 

3 that could make it more confusing for the industry, 

4 the stakeholders and the certifiers. 

5 I think it sets a precedent that is 

6 going to do nothing but add to the confusion as we 

7 look forward. We haven't done it on other 

8 materials and I'm afraid to get started down that 

9 path right now.

10 I would probably vote against it just 

11 because of the terminology that it's going to have 

12 in it.

13 MEMBER SONNABEND: Emily.

14 MEMBER OAKLEY: Well, I would just say 

15 that it's not only certifiers that look at these 

16 terms, it's farmers and -- well, especially 

17 farmers.

18 And I think they might not be looking 

19 at the OMRI decision tree. I know for myself as 

20 a farmer it would be helpful to have the non-GMO 

21 or excluded method terminology.

22 VICE CHAIR CHAPMAN: So, if you were a 
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1 farmer and you were just looking at the list and 

2 you saw 14 listings that didn't say non-GMO and 1 

3 that did? I'm going to go right back to you.

4 MEMBER OAKLEY: I'm totally happy to 

5 answer that. I wouldn't be parsing through the 

6 entire list. Like, I would be going to look for 

7 exactly my material. That's what I do now.

8 I don't read through the whole thing. 

9 I'm looking for specifically what I want. And the 

10 more detail I have, the better I can make my 

11 decision.

12 MEMBER RICE: I can respect that 

13 perspective, but I would also offer that as a 

14 certified operation you'd have to add that to your 

15 materials list before you would use it. And that 

16 would in turn put the onus on the certifier to 

17 ensure that it's listed as approved material.

18 MEMBER OAKLEY: That's true. I would 

19 always contact my certifier before I would use it, 

20 but it's just another step that helps me make clear.

21 MEMBER RICHARDSON: So, just to see if 

22 it works I would make a motion to amend the listing 
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1 motion that must be to delete the sentence that said 

2 "must be made from non-GMO soybeans."

3 MEMBER SONNABEND: Is there a second to 

4 that motion?

5 MEMBER DE LIMA: I'll second.

6 MEMBER SONNABEND: Who seconded? 

7 Lisa.

8 VICE CHAIR CHAPMAN: Did we do the 

9 motion to classify as synthetic yet?

10 MEMBER SONNABEND: No.

11 VICE CHAIR CHAPMAN: So, that's the 

12 motion on the table.

13 MEMBER SONNABEND: We have to take them 

14 in order. Okay. All right. Well, maybe we're 

15 ready to vote on the synthetic and then discuss 

16 amending.

17 MEMBER THICKE: I could go either way 

18 on this, but if we now take that out, now we're going 

19 to be on public record taking out the GMO thing and 

20 then we're going to really confuse people.

21 MEMBER SONNABEND: Not necessarily 

22 because we can explain in the cover sheet why we're 
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1 doing it and that it is excluded anyway.

2 CHAIR FAVRE: Okay, we have before us 

3 a classification motion, a motion to classify soy 

4 wax as synthetic. And we'll start the vote with 

5 Lisa de Lima.

6 MEMBER DE LIMA: Yes.

7 VICE CHAIR CHAPMAN: Yes.

8 MEMBER SEITZ: Yes.

9 MEMBER RICHARDSON: Yes.

10 MEMBER BEHAR: Yes.

11 MEMBER SONNABEND: Yes.

12 MEMBER RICE: Yes.

13 MEMBER OAKLEY: Yes.

14 MEMBER THICKE: Yes.

15 MEMBER AUSTIN: Yes.

16 MEMBER BUIE: Yes.

17 MEMBER BECK: Yes.

18 MEMBER SWAFFAR: Yes.

19 MEMBER ROMERO-BRIONES: Yes.

20 CHAIR FAVRE: The chair votes yes.

21 MEMBER DE LIMA: Fifteen yes, zero no. 

22 The motion passes.
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1 MEMBER SONNABEND: Okay, so now do you 

2 want to put your motion forward?

3 MEMBER RICHARDSON: So now I will make 

4 a motion to amend the main listing motion. The 

5 main listing motion includes a sentence that says 

6 "must be made from non-GMO soybeans." I would 

7 propose to delete that sentence from the main 

8 listing motion.

9 MEMBER SONNABEND: Lisa, are you 

10 seconding it?

11 MEMBER DE LIMA: Yes, I second.

12 MEMBER SONNABEND: Okay. That is open 

13 for discussion. Harriet.

14 MEMBER BEHAR: I just want to make sure 

15 that it does end up somewhere in a preamble that 

16 ends up in the Federal Register that our intention 

17 was that because it's being used on certified 

18 organic land that it must be derived from 

19 non-excluded methods crops.

20 MEMBER SONNABEND: Anyone -- Lisa.

21 MEMBER DE LIMA: I just want to say I'm 

22 with Harold. I'm going to have a hard time voting 
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1 for it if we can't get the language out. Because 

2 I think it's confusing for the list overall.

3 MEMBER OAKLEY: I just want to put in 

4 a last ditch effort that I think you might be 

5 missing the forest for the trees here and 

6 forgetting that there are a lot of people who look 

7 at this list that do not have nearly the depth of 

8 knowledge or interaction with it that everyone else 

9 does.

10 MEMBER SONNABEND: Ashley.

11 MEMBER SWAFFAR: I totally agree with 

12 you Emily, but there's those few who will turn this 

13 into a headline of why is it here but not here.

14 And I think it could send a really bad 

15 message to the community if we spell it out here 

16 and nowhere else.

17 MEMBER SONNABEND: Harold.

18 MEMBER AUSTIN: As a producer and a 

19 handler it's my responsibility to make sure that 

20 I'm doing the proper job to research the materials 

21 that I'm going to apply, submit that list to my 

22 certifier. 
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1 So it's a dialogue that's going to be 

2 taking place between myself and my certifier that's 

3 going to make sure that we're not using materials 

4 that are made with excluded methods, or outside of 

5 the scope of what we're supposed to be applying.

6 And that's every person that's 

7 organically certified's responsibility. We're 

8 all in this together.

9 MEMBER SONNABEND: I call on myself. 

10 And Emily, I appreciate your industriousness to 

11 look at the list, but I have to respectfully 

12 disagree.

13 Because after inspecting hundreds of 

14 farms I have almost never found one that looked at 

15 the National List directly. They rely on OMRI and 

16 their certifier to interpret what materials can and 

17 can't be used. Very rare for them to look at the 

18 list. Miles.

19 MR. MCEVOY: Yes, I'm not intimately 

20 familiar with the OMRI decision tree on GMOs, but 

21 I think if you look at it my impression is that they 

22 would not require non-GMO soy to be used in this 
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1 particular way.

2 So, if you're going to remove this then 

3 it leaves the possibility that GMO soybeans could 

4 be used in the soy wax.

5 So, by leaving it in you're clarifying 

6 that you don't want that to be used. But if you 

7 take it out it makes it to me very unclear that that 

8 is your intent if you go back to that decision tree.

9 MEMBER SONNABEND: Okay, Miles, I am 

10 very familiar with the OMRI decision tree and would 

11 disagree with the interpretation. 

12 But if we could ask Johanna or Peggy to 

13 give that clarification I would appreciate it. 

14 Can we do that?

15 CHAIR FAVRE: Yes, if they're here in 

16 the audience. The information that I've gotten on 

17 it is that it would require non-GMO soybeans and 

18 it would go back all the way to the original source.

19 MEMBER SONNABEND: Yes. The only 

20 exception in the OMRI decision tree is for 

21 soil-applied GMO components like soy oil because 

22 the soil would buffer any residual -- there can be 
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1 small amounts of residual GMOs in some oils. It 

2 depends how highly refined it is.

3 And so the OMRI exemption is only for 

4 soil application which a log is not. Can we ask 

5 them? So, Johanna or Peggy.

6 CHAIR FAVRE: Is Johanna or Peggy in 

7 the audience? Okay. Do you want to weigh in on 

8 this as we shine the spotlight on you?

9 MEMBER SONNABEND: You need to come to 

10 the microphone, please. 

11 PARTICIPANT: I would be very, very 

12 happy to provide information in writing to you all 

13 on this, but I don't know if I'm comfortable.

14 MEMBER SONNABEND: So to capture that 

15 for the record she doesn't want to comment at this 

16 time but she could supply us with written 

17 information later.

18 I am one of the coauthors of that 

19 decision tree though and know how it is applied all 

20 the time. Tom then Harriet.

21 VICE CHAIR CHAPMAN: Does it make sense 

22 at this point to send this item back to the 
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1 subcommittee for further review? Bring it forward 

2 in the fall?

3 MEMBER SONNABEND: Harriet was next, 

4 then you.

5 MEMBER BEHAR: I know there is 

6 confusion out there in the world. If you go on the 

7 internet you'll find all kinds of advertised 

8 non-GMO soy wax on the market. 

9 But then when you dig deeper and contact 

10 the manufacturers. Of course, this is not a 

11 regulated term "non-GMO." And so you find out no, 

12 it's just because it's an oil that doesn't contain 

13 the protein that we're calling it non-GMO, but 

14 we're pretty sure it was derived from genetically 

15 modified soybeans.

16 So that's my -- I just want to make sure 

17 that -- there is some confusion in the marketplace. 

18 People with due diligence would buy that non-GMO 

19 labeled soy wax, but it wouldn't actually meet our 

20 definition of non-GMO. It meets some other market 

21 unclear definition.

22 MEMBER SONNABEND: And that's exactly 
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1 why we're trying to have our own definition of 

2 non-GMO. Francis.

3 MEMBER THICKE: I remember seeing some 

4 farmers complaining about that microcrystalline 

5 cheese wax even had to be on the list because it's 

6 like a plug. It's like a plastic cap. They 

7 figured it shouldn't even have to be on there.

8 And so it's not really considered by a 

9 lot of people as an input. It's just like a shelf 

10 or something. 

11 And so for that reason there may be more 

12 reason to put non-GMO on there because people don't 

13 see it as an input.

14 MEMBER SONNABEND: More discussion, or 

15 a motion to go back to subcommittee, or we'll 

16 proceed to vote on the amendment?

17 CHAIR FAVRE: Yes, we have an amendment 

18 to the motion on the floor. 

19 VICE CHAIR CHAPMAN: But if we do move 

20 to refer to subcommittee.

21 CHAIR FAVRE: We can withdraw the 

22 motion, but just as a reminder we do have an open 
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1 motion on the floor.

2 VICE CHAIR CHAPMAN: I would make the 

3 motion to refer to subcommittee, but from looking 

4 around the room when I said that I didn't feel like 

5 there was strong support for that. Maybe I'm 

6 wrong. Didn't hear anyone else pick it up so I'm 

7 not going to make that motion. But if other people 

8 start speaking to it then I will.

9 MEMBER SONNABEND: So then we're going 

10 to proceed to vote on the amendment. So the 

11 amendment is to remove the last sentence of the 

12 listing motion, remove the sentence "must be made 

13 from non-GMO soybeans."

14 And anymore discussion? Harriet.

15 MEMBER BEHAR: So just in the record 

16 then if we remove this then we are then relying that 

17 all the producers will go to their certifiers first 

18 with all inputs that they are using in the Organic 

19 System Plan to receive approval before use. 

20 And their certifiers will clarify for 

21 them whether or not they meet the regulation which 

22 would include not being derived from a crop that 
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1 was produced using excluded methods.

2 MEMBER SONNABEND: Tom.

3 VICE CHAIR CHAPMAN: I'm really not 

4 comfortable in voting on this. I realize I'm also 

5 the first one up on the list.

6 I mean, the program on one end is saying 

7 we should say this. And certifiers and other 

8 people are saying we shouldn't.

9 I see both sides of this. I am going 

10 to make a motion to refer back to subcommittee.

11 MEMBER SWAFFAR: Second.

12 MEMBER SONNABEND: Who seconded. 

13 Ashley seconded.

14 CHAIR FAVRE: All right, we have a 

15 motion and a second.

16 MEMBER SONNABEND: Okay. And does 

17 that supersede the motion?

18 VICE CHAIR CHAPMAN: I'm sending all of 

19 that to subcommittee.

20 CHAIR FAVRE: Hold on a minute.

21 MEMBER SONNABEND: Wait, they have to 

22 withdraw the motion to amend first.
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1 (Simultaneous speaking.)

2 MEMBER SONNABEND: So, does the maker 

3 of the motion, or do we need a parliamentarian here?

4 I mean, I think a motion to table 

5 supersedes the amending motion, but --

6 CHAIR FAVRE: I don't think it does. 

7 Emily's got her hand up over there.

8 MEMBER SONNABEND: Emily.

9 MEMBER OAKLEY: I'm just going to note 

10 that I don't think sending it back is going to 

11 provide everybody else in this room clarity. 

12 I think that there was clarity at the 

13 subcommittee level when this was proposed. And I 

14 wasn't officially on the Board at that time, but 

15 I listened in on that meeting and it was crystal 

16 clear what the intent was.

17 I also think the fact that Miles is 

18 promoting that idea is something everyone should 

19 listen to.

20 And I don't know what the final rule 

21 would be, but it might just end up including it 

22 anyway. So, just putting that out there.
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1 MEMBER SONNABEND: So probably we 

2 should vote on the amendment because it was already 

3 on the floor. And once that's voted on if it fails 

4 then you could put in a motion to go back to 

5 subcommittee. Or either way you could before we 

6 vote it onto the list.

7 CHAIR FAVRE: I'd actually like to 

8 propose we take a break. We're about due to take 

9 our break anyway.

10 MEMBER SONNABEND: And then have to 

11 rehash the discussion all over again?

12 CHAIR FAVRE: No, but I call an 

13 emergency break.

14 (Laughter.)

15 CHAIR FAVRE: We're going to take a 

16 15-minute break and reconvene at 3:20. And this 

17 will take the place of our planned break at 3:15 

18 so everybody knows. So 3:20, everybody come back 

19 here, please. 

20 (Whereupon, the above-entitled matter 

21 went off the record at 3:05 p.m. and resumed at 3:28 

22 p.m.)
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1 CHAIR FAVRE: All right, we're going to 

2 get started back again.

3 Okay, just to remind everybody where we 

4 were at we were having a discussion on whether or 

5 not we were going to send this back to committee 

6 or go ahead with the amended motion.

7 And I believe the last person talking 

8 was Tom.

9 VICE CHAIR CHAPMAN: I had made a 

10 motion and it was seconded by Harold or Ashley. 

11 Ashley. To refer to subcommittee.

12 CHAIR FAVRE: Okay, so we have a motion 

13 and a second to refer it to subcommittee. 

14 We have conferred with the 

15 parliamentarian and that motion actually takes 

16 precedence or priority over the motion to amend the 

17 listing. So therefore we are going to go ahead and 

18 vote on the motion to send it back to committee 

19 before we decide about amending the listing motion.

20 And I believe the vote starts with Tom.

21 VICE CHAIR CHAPMAN: And it's a 

22 majority motion, right?
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1 CHAIR FAVRE: Yes, this is a simple 

2 majority, not a two-thirds majority motion just for 

3 the FYI to the members.

4 VICE CHAIR CHAPMAN: Yes.

5 MEMBER SEITZ: Sending this back to 

6 committee.

7 CHAIR FAVRE: Yes, this is the motion 

8 to send it back to committee. So a yes motion would 

9 send it back without further vote on the listing 

10 motion.

11 MEMBER SEITZ: Yes.

12 MEMBER RICHARDSON: Yes.

13 MEMBER BEHAR: Yes, please.

14 MEMBER SONNABEND: Yes.

15 MEMBER RICE: Oh yes.

16 MEMBER OAKLEY: Considering the room, 

17 yes.

18 MEMBER THICKE: Abstain.

19 MEMBER AUSTIN: Yes, ma'am.

20 MEMBER BUIE: Yes.

21 MEMBER BECK: Yes.

22 MEMBER SWAFFAR: Yes.
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1 MEMBER ROMERO-BRIONES: Yes.

2 MEMBER DE LIMA: Yes.

3 CHAIR FAVRE: The chair votes yes.

4 MEMBER DE LIMA: Fourteen yes, one 

5 abstain. The motion passes.

6 CHAIR FAVRE: Okay, so this will be 

7 headed back to committee to hopefully be discussed 

8 further and brought forward as appropriate.

9 MEMBER SONNABEND: Okay, now that 

10 brings us to one of our most juicy subjects of the 

11 whole meeting, the subject of inerts, and in 

12 particular first, nonylphenol ethoxylates.

13 When we first undertook this program to 

14 work with the EPA Safer Choice we compared our list 

15 of known inerts which is now several years old, but 

16 at least captures most of the known inerts in 

17 organic products with what EPA Safer Choice had 

18 already reviewed.

19 And we came up with therefore how many 

20 things would still need to be worked on. And while 

21 we're still actually working on a more accurate 

22 version of that list in light of testimony we 
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1 received at the last NOSB meeting it became clear 

2 that there were going to be a few inerts that are 

3 in use in organic materials now but which would not 

4 pass their -- which they've already reviewed and 

5 would not pass the Safer Choice screening.

6 One category of these was nonylphenol 

7 ethoxylates. And we decided as a subcommittee 

8 maybe over a year ago now that it would be a shame 

9 if we waited till the very end of the whole review 

10 process which could be easily 8 to 10 years from 

11 now until everything gets transferred over to the 

12 new system, and then all of a sudden have this group 

13 of leftover things that people would not be 

14 notified about until then as far as the need for 

15 reformulation.

16 Because while some people say that, oh, 

17 they'll think of it on their own when they see it 

18 coming, but that just isn't the way the world works.

19 And so we decided we should do a TR on 

20 these things which we have done. And the TR made 

21 it very clear that they were not really appropriate 

22 for organic production.
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1 And so now we're starting the process 

2 of letting the community know, the community who 

3 makes products know that these things are going to 

4 be phased out.

5 So this is the first step of this. I 

6 mean, we did actually put one paragraph in the 

7 annotation change proposal regarding this. 

8 But now we've come with a discussion 

9 document. And the main purpose of the discussion 

10 document is to start collecting information from 

11 stakeholders about how long it's going to take them 

12 to reformulate and ask them to provide suggestions 

13 for how to outreach to the parties that will be 

14 affected, i.e., the formulators.

15 We didn't get a lot of comments back on 

16 this, but we did get quite a bit of misunderstanding 

17 I felt among our regular commenters who seemed to 

18 think that it would be three years and the clock 

19 would start ticking from this discussion document. 

20 And this just is not the way the world works in 

21 organic regulations. 

22 Nothing happens starting from a 
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1 discussion document. No timeline ever happens 

2 from that.

3 And so the intent was to -- at a point 

4 this proceeds to a recommendation that it would 

5 then be a proposal from the Materials Subcommittee, 

6 and then a recommendation passed by the Board.

7 And even then the clock doesn't start 

8 ticking, but the recommendation will have a 

9 suggested timeline in it.

10 And when that is turned into 

11 rulemaking, that's when the clock actually starts 

12 ticking.

13 So, you can see why things take so long. 

14 And if they didn't have so many FOIA lawsuits they 

15 might be able to do things quicker.

16 But nonetheless this is happening at 

17 its pace of us being able to eventually remove these 

18 things.

19 We did -- so as I say, most of the public 

20 comment involved either hurry up and do this, or 

21 three years isn't long enough. I'd have to say we 

22 expected that.
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1 But the three years isn't long enough 

2 complaints weren't -- we made at least the affected 

3 parties who commented understand better. And most 

4 of them didn't think it would be three years from 

5 the discussion document, that it would be a longer 

6 period of time.

7 Unfortunately we didn't get very many 

8 answers to our question three which was to provide 

9 suggestions for outreach to the parties affected 

10 by this change.

11 But I am happy to see at least some of 

12 the formulators have been here in the room and are 

13 aware, and the formulators associations are aware 

14 of this and will take this back to their members.

15 We got a significant amount of comment 

16 that this will be much harder to do in livestock 

17 teat dips where the NPEs are used.

18 We may by the time we go to proposal come 

19 with a separate one for livestock than from the 

20 Materials Subcommittee, or we may not, or we may 

21 not do anything. Not separately Jean's saying. 

22 Not do anything.
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1 Okay, well we'll make that clear if 

2 we're going to separate out the livestock issues 

3 from the crops ones.

4 So, I will have to say then speaking 

5 just for crops I think this is going to come 

6 eventually.

7 The EPA has publicly stated that while 

8 they're not taking action to remove them, they 

9 would be really happy if these things would be 

10 removed. And therefore this will proceed.

11 However, I will also have to say that 

12 those commenters who said well, you shouldn't do 

13 this before the annotation rule is in place were 

14 absolutely correct. And it was not my intention 

15 to advance this to the recommendation stage until 

16 we do have the rulemaking on the annotation which 

17 might be a little while from now, but at least we 

18 will have had the notice to the community that this 

19 is going to happen after that happens.

20 So, any questions or comments on this? 

21 MEMBER BEHAR: So this brings up that 

22 we don't necessarily have a procedure for not 
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1 allowing things that are on the Safer Choice list.

2 And when you say that EPA likes the idea 

3 of removing it, would we ask EPA to completely 

4 remove it from the Safer Choice list, or it's just 

5 that it would not be allowed in organic production?

6 MEMBER SONNABEND: These are not on the 

7 Safer Choice list. Safer Choice told us these 

8 would not make it through their program. 

9 And the EPA also didn't say they liked 

10 this. The EPA said -- the EPA issued a statement 

11 -- I don't know where I put it. I think it was in 

12 the last version. But anyway, they didn't exactly 

13 say stop using them, and they didn't say they were 

14 happy we were doing this or anything that direct.

15 But they did indicate that they didn't 

16 feel that these things had much of a future. I 

17 don't have the language with me, I'm sorry.

18 Anyone else? Okay. So it was as I 

19 mentioned just a discussion document. The 

20 subcommittee will talk about when it's appropriate 

21 to bring it forward again.

22 So now we're going to have a little
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1 update from Emily Brown Rosen about the Inerts 

2 Working Group which will answer your question about 

3 the procedure that will -- well, it won't answer 

4 your question. It will give a progress report on 

5 the issues we're working on around the procedures. 

6 Emily.

7 MS. BROWN ROSEN: Okay, thank you. 

8 I'm just going to read a little statement -- I don't 

9 have a PowerPoint on this, but we will put this 

10 statement, post it with the proceedings so people 

11 can refer to it if they need to.

12 This is the Inerts Working Group 

13 update. And my name's Emily Brown Rosen with the 

14 Standards Division at USDA, AMS-NOP.

15 Inert ingredients are any substances 

16 other than an active ingredient which are 

17 intentionally included in a pesticide product.

18 Examples would include adjuvants, 

19 solvents, diluents, stabilizers and 

20 preservatives.

21 Last October at your October meeting 

22 2015 the NOSB supported a recommendation to amend 
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1 the National List regarding the use of inert 

2 ingredients in pesticides.

3 The NOSB recommended changes that would 

4 remove the current categorical allowance for 

5 inerts that appear on the now obsolete EPA List 4A, 

6 4B and List 3. List 3's were the ones you were 

7 looking at for a sunset review for 2018 and they 

8 are currently only allowed for use in passive 

9 pheromone dispensers.

10 The recommendation supported replacing 

11 this with several new options. So, just as a 

12 reminder these options included those inerts 

13 appearing on the EPA's Safer Chemical Ingredient 

14 List, otherwise known as SCIL, those that are 

15 approved by EPA for what they call the 25B products, 

16 those pesticide products that are exempt from 

17 registration, and those inerts that are approved 

18 by EPA for use in pheromones when used in passive 

19 dispensers.

20 And also it would preserve the option 

21 for petitioners to specifically petition and add 

22 individual inerts on the National List. So it's 
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1 like a new framework for reviewing and 

2 incorporating allowance for certain inert 

3 ingredients.

4 So, the Inerts Working Group consists 

5 of at the present time two NOSB members, Jean 

6 Richardson, Zea Sonnabend and NOP staff which is 

7 Lisa Brines, myself, and Paul Lewis has been 

8 joining us. And we also have several people from 

9 the EPA Office of Pesticide Programs, Chris Pfeifer 

10 and Kerry Leifer.

11 We met last November and then NOP met 

12 further with the Safer Choice program to discuss 

13 what the next steps would be for this program.

14 A couple of key points that we did 

15 discuss in light of the comments at the last NOSB 

16 meeting were, one, the need for regular updates 

17 from the Safer Choice program to NOSB regarding 

18 their list and any additions to their list.

19 And then what type of oversight the NOSB 

20 could have over continuing monitoring of these 

21 decisions and additions.

22 The other points were what would an 
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1 approved SCIL list look like to identify inerts 

2 that are approved for organic production. 

3 How would manufacturers apply. What 

4 is the process. And four, what kind of outreach 

5 to manufacturers can be done.

6 There remains a lot of work to do on this 

7 project. Before we move forward with a rulemaking 

8 docket to formalize the change to the National List 

9 the NOP has a number of other pressing rulemaking 

10 projects to complete.

11 Notably, we have to get the 2016 and 

12 2017 sunset revisions all processed through 

13 notices and final rules.

14 We will proceed with the proposed 

15 rulemaking including submitting a work plan. We 

16 have to get a work plan approved to OMB for this 

17 project. We have to draft all the supporting 

18 background information and the regulatory language 

19 as soon as we have resources available and get it 

20 in the queue.

21 Some of our additional short-term work 

22 plans include reviewing a compiled list of known 
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1 inert ingredients in organic, comparing it to the 

2 SCIL list to identify the outstanding one.

3 Identify the inerts that already appear 

4 on the SCIL list and so don't need further action.

5 We have to also identify which of the 

6 SCIL substances have EPA tolerances or tolerance 

7 exemptions for use as inert ingredients in 

8 pesticides. 

9 Because not everything on the SCIL list 

10 has an EPA tolerance so it will not automatically 

11 qualify. 

12 They have different categories of 

13 ingredients there. If you're not familiar with 

14 that program they have -- they review all different 

15 types of chemicals and put them in different 

16 categories like surfactants or solvents.

17 A lot of them are used as ingredients 

18 in industrial cleaning products, that type of 

19 thing. It's not really designed for inert 

20 ingredients, but there does happen to be overlap 

21 in that many of these ingredients are also used as 

22 inert ingredients. That's why the whole program 
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1 is of interest.

2 So, we plan to continue to meet on a 

3 regular basis to work out the details of the program 

4 and NOP is committing to getting started on the 

5 necessary background rulemaking work.

6 So that's all I have. If you have any 

7 questions I'd be happy to answer them. Harriet.

8 MEMBER BEHAR: So you mentioned that 

9 you were going to compile a list of the inerts that 

10 are being used in products that are used on organic

11 land.

12 MS. BROWN ROSEN: We have a list, but 

13 it's not necessarily particularly accurate. We 

14 received some help from OMRI and WSDA back in 2013 

15 to give us a pooled list of inerts that they know 

16 are in products, but not associated with any 

17 product names, just the ingredients themselves.

18 So, we have that list. I don't know 

19 that it's up to date, but we can start with that 

20 to get a rough idea of which ones already appear 

21 on the SCIL so we know how big of a problem we have 

22 as far as getting the other needed ones reviewed 
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1 and looked at carefully.

2 MEMBER BEHAR: Were you going to do any 

3 outreach to certifiers on that?

4 MS. BROWN ROSEN: As we get further 

5 along. What did you have in mind?

6 MEMBER BEHAR: Well, just what inerts 

7 that they know. 2013 is three years ago.

8 MS. BROWN ROSEN: We haven't decided 

9 yet.

10 MEMBER BEHAR: Maybe if you compile it 

11 then you can say is there anything beyond this list 

12 or something like that.

13 MS. BROWN ROSEN: Well, yes. That's 

14 certainly under discussion. We may have at some 

15 point reach out in general to do a call in for more.

16 Once we have the procedure for the 

17 program I think better sketched out then we can do 

18 more publicity and get more feedback on that.

19 Okay, thank you.

20 MEMBER SONNABEND: This concludes the 

21 Crops Subcommittee business.

22 CHAIR FAVRE: Thank you, Zea. Okay, 
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1 since we have no deferred proposals or final votes 

2 and we already took our break we are now at the 

3 subcommittee work agenda place.

4 Okay, so this is our current working 

5 agenda for the various subcommittees. I'm going 

6 to turn it over to each of the subcommittee chairs.

7 I should state that the process that 

8 we're using here for subcommittee updates is that 

9 it's proposed in subcommittee or through an issue 

10 that's brought forward to the Board from public 

11 comment or elsewhere.

12 It comes out as a recommendation from 

13 the subcommittee brought to the executive 

14 subcommittee. And then basically there's a 

15 write-up as part of that that describes what it is 

16 that we're hoping to do.

17 We've tried to formalize the process 

18 somewhat so that we don't have a lot of very vague 

19 and so broadly termed projects on the Board that 

20 we can't effect completion of those projects. And 

21 so we have a lot of dangling participles out there.

22 And so then they'll come before the 
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1 executive subcommittee and submitted and discussed 

2 with the NOP.

3 And then we get formal acknowledgment 

4 from the NOP. We add it officially to the work 

5 agenda.

6 That work agenda will be officially 

7 presented in the fall. And so you will probably 

8 see some of the discussion items that have come up 

9 at this Board meeting as well as some things that 

10 have still been outstanding in subcommittee.

11 So, I just wanted to say that as a 

12 preface because there's probably some things on 

13 here you'd think well hey, wait a minute, I thought 

14 we were going to add this.

15 This is what we came into this meeting 

16 with before we had the discussions here today. So, 

17 are all the Board members clear on that? Okay.

18 So I'm going to turn it over first of 

19 all to Carmela for CACS.

20 MEMBER BECK: So, as we talked about 

21 earlier there's one agenda item we'll be looking 

22 at in NOP Instruction 2027, specifically the 
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1 requirement to do annual infield inspections of 

2 inspectors. And that's all we have at this point 

3 in time.

4 CHAIR FAVRE: Just as a reminder, we 

5 did have the issue of the removing the incentive 

6 to convert native lands that potentially is going 

7 to be brought forward to the subcommittee.

8 MEMBER BECK: Sure.

9 CHAIR FAVRE: Is there anybody else on 

10 the subcommittee that has any comments or 

11 discussion? 

12 MR. MCEVOY: Yes, just a comment about 

13 the NOP 2027. We've implemented this instruction 

14 to certifiers.

15 As was said in public comment it's 

16 always been a requirement that inspectors meet 

17 certain qualifications and that they are evaluated 

18 on an annual basis.

19 What we clarified in 2027 was that they 

20 needed to be evaluated in the field and not just 

21 a desk review of their work, not just looking at 

22 their inspection reports.
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1 We had seen through our audits of 

2 certifiers that there were some certifiers that had 

3 never actually observed the inspectors operating 

4 in the field.

5 We felt that that was very much a 

6 deficiency in terms of ensuring the quality of the 

7 inspection work.

8 Therefore we issued this instruction to 

9 certifiers to clarify that actually seeing how an 

10 inspector operates and ensuring that they're being 

11 thorough, and the right demeanor, and following 

12 procedures is really, really important.

13 We have gotten a lot of feedback from 

14 certifiers that have really appreciated the 

15 clarification, but also are concerned about the 

16 cost, the impact on doing this on an annual basis, 

17 doing these field evaluations on all their 

18 inspectors on an annual basis.

19 We had conversations with the 

20 certifiers. We have modified the instruction 

21 somewhat and we'll continue to have conversations 

22 with certifiers to see how we can ensure that 
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1 there's quality inspections and quality 

2 evaluations of those inspectors that continues, 

3 but see if there's some way to provide a little more 

4 flexibility in that process.

5 So we look forward to working with the 

6 Board as well as certifiers on that important part 

7 of maintaining organic integrity. Thanks.

8 CHAIR FAVRE: Okay, next up is Crops. 

9 Zea.

10 MEMBER SONNABEND: I thought I had a 

11 newer version than this one you sent us this 

12 morning, Tracy. I guess it's up there.

13 Okay. So, we have several petitions 

14 that we're working on.

15 The aluminum sulfate, it's a litter 

16 additive or what do you call it -- amendment, thank 

17 you. But it has to be reviewed on crops because 

18 the resulting litter-manure mixture will be spread 

19 on fields.

20 We have one for 1-MCP which is a 

21 post-harvest treatment for primarily apples. One 

22 for fatty alcohols. And two relatively new ones, 
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1 ammonium glycinate and ammonium citrate which are 

2 chelating agents for micronutrients.

3 Then we have a brand new one that isn't 

4 on there for anaerobic digestate made by one 

5 particular method.

6 Our other projects include 

7 contaminated issues in farm inputs which Harriet 

8 has graciously agreed to lead. And we're trying 

9 to identify which parts of this very vast issue to 

10 focus on.

11 So we don't know what the end product 

12 will be on that, but we'll at least have some sort 

13 of update I hope by fall.

14 The biodegradable biobased mulch which 

15 we don't know will turn into a proposal or a review 

16 or what, but we are taking that up again.

17 The prohibition of NPEs as I mentioned 

18 might advance to proposal, but possibly not by fall 

19 and so that probably should be a TBD in the 

20 timeline. We'll talk about it when it comes.

21 And then the anaerobic digestate which 

22 is now an other project because the petition we had 
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1 from it from last year got withdrawn, but it raised 

2 some bigger issues. And now that we have a new 

3 petition those bigger issues still exist. 

4 But we probably will handle it as a 

5 petition and just ask for a broader scope of the 

6 TR that we're going to do so that it doesn't 

7 encompass just one way to make anaerobic digestate, 

8 but it encompasses some of the other ways that 

9 anaerobic digestate will be made.

10 So, the petition only came this week and 

11 so we haven't discussed that yet in subcommittee.

12 We're expecting the hydroponics report 

13 back from the task force in June approximately. 

14 And so we will be -- that report will be presented 

15 at the fall NOSB meeting formally and the committee 

16 will start working on whatever proposals will come 

17 from that report.

18 We're expecting a TR back on the marine 

19 materials which will affect all of the crops, 

20 livestock and handling. But we will look at the 

21 crops portion of that and possibly have a 

22 discussion document or some other activity around 
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1 that.

2 We have put in for a TR on newspaper 

3 because a really complete TR had never been done 

4 and questions came up during the sunset review that 

5 may want us to consider an annotation change in 

6 light of newer technologies for creating paper and 

7 ink.

8 And then our most recently approved 

9 work agenda item in light of the seed purity 

10 discussion document was to take another look at the 

11 guidance on seed and planting stock and see if we 

12 could strengthen particularly the seed portion and 

13 possibly also the planting stock.

14 So, that's a pretty -- and then of 

15 course we have the sunset 2018 items. And so 

16 that's a pretty full agenda we have for the next 

17 semester.

18 MR. MCEVOY: Yes, on the anaerobic 

19 digestate topic we have additional information 

20 that we'll be providing to the Board in a memo to 

21 the Board within the next couple of weeks to provide 

22 more background, more questions for the Board to 
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1 consider on that particular topic. 

2 So look for that in the next couple of 

3 weeks. That will be sent to the Board and then 

4 posted on the AMS website for the public to see as 

5 well.

6 MEMBER SONNABEND: Thank you. 

7 CHAIR FAVRE: Okay, next up is 

8 Handling. Harold.

9 MEMBER AUSTIN: Thanks, Tracy. Okay, 

10 so for handling for this upcoming semester for 

11 petition materials we've got chlorine dioxide dry 

12 gas to look to adding that to 205.605.

13 Oat protein concentrate, looking at 

14 that to add it to 205.605.

15 We also -- from a petition material 

16 perspective we also have SDBS back to the 

17 subcommittee that we just referred back today.

18 Other projects that we'll be working 

19 towards. Fall will be packaging substance used in 

20 organic food handling including BPA. Xanthan gum 

21 reclassification proposal. Tocopherols. 

22 Nutrient vitamins and minerals annotation change.
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1 Phosphate annotation change. The 

2 marine materials likewise we will be looking at 

3 that in handling and how that applies. Here we've 

4 got it down as a proposal. In crops we had it as 

5 a discussion document. I think that's yet to be 

6 determined. Once we get the TR back which we have 

7 not received yet, and then we'll figure out how we 

8 take and work with that.

9 Magnesium chloride reclassification 

10 proposal due for the fall. 

11 And then we've got our sunset 2018 

12 materials which consist of agar-agar, animal 

13 enzymes, calcium sulfonate mined, carrageenan, 

14 glucono delta-lactone, tartaric acid, cellulose, 

15 potassium hydroxide, silicon dioxide and colors 

16 beta carotene extract.

17 CHAIR FAVRE: Thank you, Harold. Next 

18 up is Livestock. Ashley.

19 MEMBER SWAFFAR: Sorry, we kind of 

20 already went over a lot of this, but in livestock 

21 what we'll be bringing to fall are four petitions, 

22 aluminum sulfate, sodium bisulfate, acid activated 
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1 bentonite which are all poultry litter amendments 

2 and sulfur.

3 Our other projects that we're currently 

4 working on is the Organic Poultry Working Group.

5 And we're also monitoring the marine 

6 materials work that's being done by the Crops and 

7 Handling Subcommittee. 

8 And I'm very lucky to have a whole lot 

9 of new members on our subcommittee so we're going 

10 to be bringing forward a lot of extra things since 

11 they're all eager and ready to get to work. Yes, 

12 Jean.

13 MEMBER RICHARDSON: I note that the 

14 lignin sulfonate is still there under aquaculture. 

15 I believe the petitioner withdrew that petition. 

16 It says aquaculture lignin sulfonate chelating 

17 agent. 

18 Oh, it was the one for plants. All 

19 right. Because it was the other lignin sulfonate 

20 that was withdrawn for the feeds. Okay.

21 CHAIR FAVRE: And just as a reminder to 

22 folks we have discussed here at this meeting and 
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1 just prior to this Board meeting in livestock the 

2 intent to bring forth a request to add an emergency 

3 use definition for use of parasiticides to the 

4 livestock work agenda. But we have not done that 

5 yet.

6 I'm sorry, yes. And also the proposal 

7 to remove -- a petition to remove Ivermectin from 

8 livestock 603.

9 MEMBER SWAFFAR: Miles.

10 MR. MCEVOY: The Poultry Task Force is 

11 still on the list, but we're still not sure what 

12 the purpose. Still working on it? Okay. 

13 So we're waiting to hear back from the 

14 Board of what you're thinking about. Is this a 

15 task force? Is it a working group? Is it an 

16 official task force that reports to the Board? 

17 What is their scope of the information that you're 

18 looking for.

19 So we're looking forward to hearing 

20 more clarification about what you're looking for 

21 there.

22 MEMBER SWAFFAR: So, just to respond to 
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1 that. I owe the subcommittee next week the 

2 proposal for you. We're going to work it over and 

3 hopefully by the end of May get you our proposal. 

4 So that's kind of our timeline.

5 CHAIR FAVRE: I just wanted to add that 

6 we sort of felt like we wanted to at least see the 

7 draft regulations for animal welfare. 

8 Because it felt like maybe some of that 

9 would be designated in that, and we wanted to make 

10 sure that we weren't duplicating efforts. So now 

11 that that's out I feel like we can really bite into 

12 that and get you something.

13 Okay, is that it? Next up is policy 

14 development. Tom. Sorry, Materials. GMO. 

15 Lisa. 

16 MEMBER DE LIMA: So, we have four 

17 proposals we'll be looking to bring forward to the 

18 fall meeting. A research priorities proposal 

19 which we do annually, the seed purity from GMOs and 

20 the excluded methods terminology.

21 And then we're also looking to bring a 

22 five-year report to the Secretary of Ag on GMO 
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1 issues overall in organic production.

2 CHAIR FAVRE: Zea.

3 MEMBER SONNABEND: One very minor 

4 clarification. I think it will have to be once 

5 again an excluded methods terminology proposal and 

6 also a discussion document. Because we're never 

7 going to have it all finished.

8 CHAIR FAVRE: Okay. Next up is policy 

9 development. Tom?

10 VICE CHAIR CHAPMAN: Who here was 

11 hoping they didn't have to hear me say the words 

12 PPM again today?

13 So, on policy development we have three 

14 items. Sunset reorganization, taking the 

15 feedback we got from this meeting and moving it 

16 forward.

17 An update to the member guide and the 

18 updates to the PPM are ongoing standing items for 

19 the PDS.

20 CHAIR FAVRE: Okay, thank you. So 

21 folks, like I said, that's the current work agenda. 

22 We'll probably have some items that we'll be adding 
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1 to it between now and the fall when you see us again.

2 Next up on our agenda is presentation 

3 of the appointment letters and certificates for 

4 incoming members. I believe we'll turn that over 

5 to Miles.

6 MR. MCEVOY: Okay, so the new members 

7 have already been initiated for the last few months 

8 and also the last few days. 

9 So I think first of all we should give 

10 them a big round of applause for already what 

11 they've contributed to the organic community in 

12 surviving.

13 (Applause.)

14 MR. MCEVOY: So I have plaques and 

15 letters from Secretary Vilsack to welcome and 

16 acknowledge their appointment to the National 

17 Organic Standards Board and their contributions 

18 that they'll make to the organic community over the 

19 next number of years.

20 So first of all to Harriet Behar. It 

21 says a certificate of appointment presented to 

22 Harriet Behar with appreciation for accepting the 
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1 call to serve the nation and the United States 

2 Department of Agriculture as a member of the 

3 National Organic Standards Board.

4 Secretary of Agriculture Tom Vilsack.

5 (Applause.)

6 MR. MCEVOY: Next I have another 

7 certificate of appointment presented to Emily 

8 Oakley with appreciation for accepting the call to 

9 serve the nation and the United States Department 

10 of Agriculture as a member of the National Organic 

11 Standards Board.

12 So thank you, Emily, for your service.

13 (Applause.)

14 MR. MCEVOY: Okay. Tracy says I don't 

15 have to read each one.

16 Okay, so the next one is for Dan Seitz. 

17 I pronounced it right? Thank you. Dan, thank you 

18 so much.

19 (Applause.)

20 MEMBER SEITZ: I just want to say this 

21 is the first time I've ever gotten a certificate 

22 for future work and I really appreciate it.
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1 MR. MCEVOY: Next I have a certificate 

2 for A-dae Romero-Briones for her service.

3 (Applause.)

4 MR. MCEVOY: Next I have a certificate 

5 for Jesse Buie for his service to the nation and 

6 USDA.

7 (Applause.)

8 MR. MCEVOY: And finally to Scott Rice 

9 for the certifier representative. Thank you, 

10 Scott.

11 (Applause.)

12 CHAIR FAVRE: Thank you, Miles. Okay, 

13 is there other business to be attended? 

14 Okay, well we're at that segment of the 

15 program when we're all sad to see it end. Harriet, 

16 yes. Oh yes, I'm sorry.

17 MS. ARSENAULT: Madam Chair, can we 

18 make the group photo other business?

19 CHAIR FAVRE: Well, no, we'll do that 

20 after we adjourn the meeting. Nice try but no.

21 Yes, we have some closing remarks. To 

22 continue and bookend our session here this week I'd 
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1 like Harriet to read us some inspirational lines.

2 MEMBER BEHAR: I know it by heart. 

3 Since we're in the Robert Frost mode.

4 And this is for this time of year and 

5 you'll just hear the poem.

6 Nature's first green is a gold,

7 Her hardest hue to hold,

8 Her early leafs a flower, 

9 But only so an hour.

10 Then leaf subsides to leaf.

11 So Eden sank to grief,

12 So dawn goes down to day.

13 Nothing gold can stay.

14 CHAIR FAVRE: Well, hopefully we 

15 aren't going to descend from Eden during my term 

16 on the Board. And we may have to start paying 

17 royalty to Robert Frost's estate for all the use 

18 of his language for inspiration, but thank you very 

19 much.

20 I'd just like to close this session 

21 today by saying I appreciate all the work from the 

22 members on the Board, particularly new members. 
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1 We threw you into some pretty deep waters at this 

2 session and I think you handled it quite admirably, 

3 much better than I would have done in your shoes.

4 And I'm very, very pleased and 

5 delighted with the engagement and the insight 

6 demonstrated by our new cohort of Board members so 

7 I want to thank you all for that.

8 And I also want to thank -- it's 

9 definitely taken a village for me to manage this 

10 meeting this week. There's been quite a few people 

11 who've made sure that I stayed generally in my lane 

12 and between the lines and I want to thank you all 

13 for that.

14 And at this point I'd like to entertain 

15 a motion to adjourn.

16 VICE CHAIR CHAPMAN: So moved.

17 MEMBER BEHAR: Second.

18 CHAIR FAVRE: I have a motion and a 

19 second and a third. I think we can do that by 

20 proclamation. All those in favor signify by 

21 saying aye.

22 (Chorus of aye.)
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1 CHAIR FAVRE: I hereby adjourn the 

2 spring 2016 meeting of the NOSB.

3 (Whereupon, the above-entitled matter 

4 went off the record at 4:10 p.m.)

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