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 UNITED STATES DEPARTMENT OF AGRICULTURE

 AGRICULTURE MARKETING SERVICE (AMS)

 NATIONAL ORGANIC PROGRAM (NOP)

 + + + + +

 MEETING OF THE NATIONAL ORGANIC

 STANDARDS BOARD (NOSB)

 + + + + +

 MONDAY

 OCTOBER 15, 2012

 + + + + +

 The National Organic Standards

Board convened at 8:00 a.m. at the Biltmore

Hotel, 11 Dorrance Street, Providence, Rhode

Island, Barry Flamm, Chairperson, presiding.

MEMBERS PRESENT

BARRY FLAMM, Chairperson

HAROLD AUSTIN

CARMELA BECK

COLEHOUR BONDERA

JOSEPH DICKSON

TRACY FAVRE

JAY FELDMAN

JOHN FOSTER

WENDY FULWIDER

NICHOLAS MARAVELL

JEAN RICHARDSON

ZEA SONNABEND

MAC STONE

JENNIFER TAYLOR

CALVIN WALKER
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STAFF PRESENT

MILES McEVOY, Deputy Administrator, National 

 Organic Program

MICHELLE ARSENAULT, Advisory Board Specialist

MELISSA BAILEY, Director, Standards Division,

 National Organic Program

LISA BRINES, Standards Division, National 

 Organic Program

EMILY BROWN-ROSEN, Agricultural Marketing 

 Specialist

MARK LIPSON, Organic and Sustainable 

 Agriculture Policy Advisor, OSEC-MRP

JENNIFER TUCKER, Associate Deputy 

 Administrator 
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 A-G-E-N-D-A

Call to Order . . . . . . . . . . . . . . . . .4

 Dr. Barry Flamm, Chairperson

Secretary's Report. . . . . . . . . . . . . . 17

 Dr. Wendy Fulwider, Secretary

National Organic Program Update

 Miles McEvoy, Deputy Administrator,

 National Organic Program . . . . . . . 20

 Mark Lipson, Organic and Sustainable

 Agriculture Policy Advisor,

 OSEC-MRP. . . . . . . . . . . . . . . . 49

Open Public Comment . . . . . . . . . . . . . 70

Livestock Subcommittee

 Subcommittee Proposals and Summarize

 Written Comments. . . . . . . . . . . .210

 Proposal

 Nonanoic Acid (Pelargonic Acid) . . . .210

 Pet Food Amino Acids. . . . . . . . . .216

 Discussion Document: Omnivore Diets

 (Methionine). . . . . . . . . . . . . .223

 GMO Vaccines Working Group Update:

 Dr. Jean Richardson . . . . . . . . . .230

 Public Comments . . . . . . . . . . . .242

 Board Votes . . . . . . . . . . . . . .305
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1 P-R-O-C-E-E-D-I-N-G-S

2 8:03 a.m.

3 CHAIRPERSON FLAMM: Good morning. 

4 The meeting will please come to order. And

5 welcome to the National Organic Standards

6 Board fall meeting. 

7 And this is a spectacular setting

8 we have, not only the room but looking out. 

9 So it's great to be here in the Ocean State

10 and I know how Rhode Islanders are really

11 promoting local foods. I hope they'll be

12 promoting also vigorously organic foods.

13 This week a major purpose of the

14 meeting is to hear public comments. And we

15 have approximately 80 people signed up to make

16 comments. We've also received many very

17 valuable written comments that will be

18 considered in our deliberations this week.

19 Before proceeding we must approve

20 the draft agenda. Is there any changes from -

21 - the board wishes to offer to the agenda? 

22 Hearing none the agenda is approved and we'll
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1 treat that as a final agenda.

2 We may have a couple of

3 announcements. Michelle I believe has some. 

4 But before Michelle speaks I'd like to ask

5 everybody to turn off their cell phones. And

6 we have a little rule that we enforce, at

7 least with board members, NOP, if they

8 mistakenly have a cell phone go off they owe

9 everybody a drink. And of course the audience

10 could participate in that too if they would

11 like to enter the pool. 

12 Michelle, would you please give

13 the announcements you have?

14 MS. ARSENAULT: So I just wanted

15 to let everyone know that we have a new timer

16 system this year. You'll see it on the

17 podium. If you're going to come up to speak

18 hopefully you signed in on the sign-in sheet

19 that's out on the table. 

20 There's three lights on the timer. 

21 There will be a green light -- a green light

22 will illuminate when you start your 4 minutes
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1 and at 1 minute the orange or yellow light

2 will come on to warn you that you have 1

3 minute left. And when your time is over a red

4 light will illuminate and it will make a

5 really obnoxiously loud beep. So we're using

6 that this year instead of a low-tech sign that

7 we held up last year in case you were here. 

8 All right, thanks.

9 CHAIRPERSON FLAMM: Thank you,

10 Michelle. Next I'd like the board members to

11 introduce themselves starting with Jennifer

12 down on the far end.

13 MS. TAYLOR: Good morning. I'm

14 Jennifer Taylor from Florida A&M University. 

15 I'd like to welcome you here. It's such an

16 honor to be here and serve for you. I am

17 representing on the board the public community

18 consumers. Thank you. 

19 MR. MARAVELL: Good morning, my

20 name is Nick Maravell. I'm an organic

21 producer from Maryland, crops, livestock,

22 vegetables, seed, et cetera. And this is my
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1 second year on the board.

2 MR. FELDMAN: Good morning, Jay

3 Feldman with Beyond Pesticides. I chair the

4 Crops Committee and serve on the Materials --

5 Crops Subcommittee, sorry. I serve on the

6 Materials Subcommittee and the GMO task force

7 or working group as well as the Policy

8 Development Subcommittee. Thank you.

9 MS. SONNABEND: Good morning, Zea

10 Sonnabend, Watsonville, California. I sit in

11 the scientist's seat in the board and I'm also

12 as of August a newly certified organic apple

13 grower.

14 MR. STONE: My name is Mac Stone. 

15 I represent the certifiers on the board. I

16 serve on the Certification, Policy and

17 Livestock Committee. It is my second year. 

18 And I also farm with my wife and her family

19 certified organic vegetables, poultry, beef.

20 MS. FULWIDER: I'm Wendy Fulwider

21 and I have a certified organic farm in

22 Wisconsin, Ripon in Fond du Lack County. I
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1 live there with my mother and my son, Cody. 

2 And we operate a diversified livestock

3 operation with direct-to-market meat sales. 

4 We have 65 dairy heifers that are in

5 transition and we will be selling organic milk

6 next fall. I am also the animal care

7 specialist at Organic Valley.

8 MR. AUSTIN: Good morning, my name

9 is Harold Austin. I'm with Zirkle Fruit

10 Company, a family-owned operation out of

11 Washington State. We grow, pack, ship and

12 sell our own produce, apples, pears, cherries,

13 blueberries, wine grapes. I'm on the Crops

14 Committee, the CAC Subcommittee and vice chair

15 of the Handling Committee. And I'm the

16 handler representative, one of the two handler

17 representatives.

18 MS. FAVRE: Good morning, my name

19 is Tracy Favre. I serve in the environmental

20 position. I'm from Texas and Colorado and I

21 have a pecan and fig orchard in Texas. And I

22 serve on the Handling and the Livestock
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1 Committees.

2 MS. BECK: Good morning, my name

3 is Carmela Beck. I'm the organic

4 certification manager at Driscoll Strawberry

5 Associates. We're based out of Watsonville,

6 California. I'm on the Crops and the

7 Certification Subcommittees.

8 MR. FOSTER: My name is John

9 Foster and I have a bright light in my eyes

10 right now. I am one of the two handler

11 representatives. This is my third year on the

12 board. I chair the Handling Committee, also

13 sit on the Crops, Materials and Certification,

14 Accreditation and Compliance Subcommittees now

15 I guess we're calling them. And I am the

16 director of compliance for Earthbound Farm in

17 the areas of quality, food safety, and organic

18 integrity.

19 MR. DICKSON: My name is Joe

20 Dickson. I am the retail representative on

21 the board. I am with Whole Foods Market. On

22 the board I chair the Compliance,
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1 Accreditation and Certification Subcommittee

2 and I serve on the Handling, Livestock and

3 Policy Development Committees.

4 MS. RICHARDSON: Good morning, my

5 name is Jean Richardson. I am a professor

6 emerita of environmental studies, University

7 of Vermont, consultant and independent organic

8 inspector. Maple syrup producer of course,

9 organic. And I'm on four committees,

10 Livestock, Handling, Policy, Accreditation and

11 I am also on the GMO Vaccine Subcommittee. 

12 And I'm a consumer rep.

13 MR. WALKER: Good evening. Just a

14 check. My name is Calvin Reuben Walker. I'm

15 appointed to the board consumer public

16 interest. I serve on a few committees, CACC,

17 vice chair of the Policy Committee, Livestock

18 Committee, GMO Ad Hoc and the Materials

19 Committee. 

20 MR. BONDERA: Hello, everybody. 

21 Thank you for being here and thank you for

22 having me. My name's Colehour Bondera. And
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1 I am a small-scale farmer in the state of

2 Hawaii. I am here in the role of not just a

3 farmer but a participant in the Livestock

4 Subcommittee, the Crops Subcommittee. I chair

5 the Policy Development Subcommittee and I also

6 serve on the GMO Ad Hoc Subcommittee as well. 

7 And I look forward to listening to you all and

8 trying to represent the organic industry as

9 best I can. Thank you.

10 CHAIRPERSON FLAMM: And I'm Barry

11 Flamm serving as board chair this year. I'm

12 in one of the three environmental positions. 

13 I serve on the Policy and CACC and Crops

14 Subcommittees. This is my fifth and final

15 year and this is my final meeting. I have 4

16 more days.

17 I'm from Polson, Montana. I live

18 on beautiful Flathead Lake and have been

19 probably all my life a conservationist either

20 as a vocation or advocation. But one of the

21 things I'm most proud of is I was an organic

22 grower and the first certified cherry grower
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1 in the state of Montana.

2 With that I'd like Miles McEvoy to

3 introduce himself and his staff, please. 

4 Miles?

5 MR. MCEVOY: Yes, I'm Miles

6 McEvoy, Deputy Administrator for the National

7 Organic Program. And I'll have each of the

8 NOP staff introduce themselves.

9 MS. BRINES: Good morning, I'm

10 Lisa Brines. I'm in the Standards Division of

11 the National Organic Program as the National

12 List manager.

13 MS. BAILEY: Good morning, I'm

14 Melissa Bailey. I'm the director of the

15 Standards Division for the National Organic

16 Program.

17 MS. BROWN-ROSEN: Good morning,

18 I'm Emily Brown-Rosen and I'm also in the

19 Standards Division.

20 MS. TUCKER: Good morning, I'm

21 Jenny Tucker. I'm the Associate Deputy

22 Administrator of the National Organic Program.
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1 MS. ARSENAULT: Hi, I'm Michelle

2 Arsenault. Everyone knows my name from all

3 the annoying emails. And I'm the advisory

4 board specialist.

5 CHAIRPERSON FLAMM: Thank you. 

6 And I would like the past board members to

7 stand so we could recognize them for all the

8 hard work they did when they served if you

9 would, please.

10 (Applause)

11 CHAIRPERSON FLAMM: Thank you very

12 much. It's been a tradition of these meetings

13 and the board to state the National Organic

14 Standards Board mission. Thank you. 

15 Our mission briefly is to provide

16 effective and constructive advice,

17 clarification and guidance to the Secretary of

18 Agriculture concerning the National Organic

19 Program and to get the consensus of the

20 organic community. We also have a list of

21 activities. I think you can read those

22 quicker than I can read them. But it gives
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1 you an idea of what we're all about. So,

2 thank you.

3 Next I'd like to say as I

4 mentioned before this is the 10th board

5 meeting that I've attended and from the very

6 beginning I've been terribly impressed by the

7 quality of the comments and the discourse that

8 we have at these meetings. There's a lot of

9 passion because we all care about organics. 

10 We have different views because that's what

11 happens in our society anyway, in a democratic

12 society. 

13 But I think we all really care

14 about in our part of this grand organic

15 community which I've worked with a lot of

16 different groups in my life and career and I

17 think the organic community is the finest of

18 the lot.

19 As always in such meetings we need

20 rules. And most of us don't even like rules

21 but we have to have them so we can proceed and

22 get our business done and so everybody gets
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1 treated fairly. So it's sort of my obligation

2 to run through a few of these. These have

3 been discussed with all the board and I think

4 we're all onboard to do this. I can assure

5 you that I have no desire to make any rules or

6 be any tougher than necessary to keep the

7 meeting moving forward.

8 I'll just run through them very

9 briefly. All board members, we want all board

10 members to get a chance to speak before

11 another one takes a second turn, just a matter

12 of courtesy. And then closely related

13 questions, if the board member will ask

14 permission from the chair to ask that I'm sure

15 that will be granted.

16 We also don't want to give unfair

17 advantage to anybody to get more time than

18 others of you that have signed up. Everybody

19 needs to be treated equally. So we've asked

20 the board members not to ask a leading

21 question which has the purpose just to extend

22 comment time. And let's see. I think that is
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1 enough. The -- next, please. 

2 And then we have some things that

3 we'd like to ask the audience. And again,

4 many of you have been to many of these

5 meetings and this is not something that maybe

6 is really necessary but I'll go over this and

7 ask so we're all on the same level that we try

8 to talk about issues and not people. And that

9 people confine their comments to when they're

10 at the podium. And the people who have signed

11 up we'll give fair chance to speak but get a

12 chance to answer questions. 

13 And sometimes we get so enthused

14 about what we may need to do we get to talking

15 about it in a group. So, if you need to talk

16 about something we'd ask that you go out in

17 the hall. There seems to be plenty of room in

18 this building. Unlike many of the ones we've

19 held meetings in we've got a spacious place to

20 meet and talk and that. So I think that

21 pretty much covers it. 

22 I hope this is clear. If you
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1 didn't, I'll give you a chance just to look at

2 what's on the board for a second and then I

3 think we can move on. Okay, thank you.

4 Next is the Secretary's Report. 

5 Dr. Wendy Fulwider, please.

6 MS. FULWIDER: Thank you, Barry. 

7 Last session's meeting transcripts are not yet

8 available so we will approve those at the next

9 meeting. The voting results were recently

10 sent to all of you for approval. So with

11 that, does anyone have any changes?

12 CHAIRPERSON FLAMM: Hearing no

13 changes the voting record is accepted and

14 we'll be, as Wendy stated, we'll be voting on

15 the transcript for the Albuquerque meeting at

16 our next board meeting. Thank you.

17 Next, Miles McEvoy, Deputy

18 Administrator, will give the report on the

19 National Organic Program. And also we're very

20 pleased to have Mark Lipson, the USDA Organic

21 and Sustainable Agriculture Policy Advisor

22 here to talk with us. So we're very
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1 appreciative of Mark coming to this meeting.

2 I apologize. I missed something

3 on my notes here. Thank you, Miles, for

4 reminding me. And I don't know how I could

5 forget this because we've been talking about

6 it for quite awhile and had many, many

7 discussions. 

8 Anyway, many -- as most of you

9 probably know we've been examining to begin

10 with at the request of the organic community

11 the board's conflict of interest policy. And

12 that will be discussed, proposals, later on in

13 the meeting. 

14 Here I just want to run through

15 how this meeting will operate. I think for

16 one thing the National Organic Program

17 receives their guidance from the USDA Office

18 of Ethics. So they're getting advice on how

19 FACA committees like this board operate. 

20 I think we all want the same

21 thing. Board members represent the interest

22 of those they represent. Board members will
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1 recuse themselves when there is a conflict of

2 interest and the public has confidence in the

3 integrity of the board decision-making. And

4 that is so important to all of us and that

5 we're transparent. Next, please.

6 Procedurally what we did this time

7 is that the National Organic Program provided

8 a spreadsheet listing all the proposals before

9 the board members and seek them to evaluate

10 what their interests were and if there was a

11 conflict. And if a board member had a

12 conflict with a proposal that board member

13 would recuse themselves before voting, but if

14 a member wasn't sure that they were to consult

15 with the National Organic Program.

16 As it turns out we had nobody --

17 for the issues before the board here nobody

18 reported any problems and any need for

19 recusal. In this meeting to support the

20 transparency to start each subcommittee

21 session members may share any interest related

22 to a proposal and we'll announce if a recusal
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1 is needed.

2 Let's see, I think that covers it. 

3 And thank you, I apologize for missing that,

4 Miles. I don't know how I did that. Thank

5 you. 

6 MR. MCEVOY: Okay, good morning. 

7 Well, it's great to be here again in New

8 England, the first meeting in New England for

9 awhile, I don't know how long. It's hard to

10 keep track anymore, there's been so many

11 meetings.

12 This is -- one thing we're going

13 to celebrate during this week is 10 years of

14 the USDA Organic Program since the

15 implementation in October of 2002. So 10

16 years for that, but it's also the 20-year

17 anniversary of the National Organic Standards

18 Board. The first meeting was in the fall of

19 1992 so 20 years of board meetings. There's

20 been a few people that have been to most of

21 the board meetings which is really pretty

22 amazing. 
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1 I think Emily Brown-Rosen on the

2 NOP staff has been to most of the board

3 meetings. Anybody else want to claim they've

4 been to most board meetings? Katherine

5 DiMatteo, yes. And Zea, yes. Okay. So

6 really an amazing event that we do twice a

7 year, one of my favorite times of year. Just

8 kidding. 

9 But what I'm going to do here is

10 I'm going to give an overview of the National

11 Organic Program, some of the things that we're

12 working on, implementation of a lot of the

13 NOSB recommendations. And then from there I'm

14 going to turn it over to Mark Lipson who's

15 going to have a short video from Deputy

16 Secretary Merrigan and talk about some USDA17 wide activities. So, next slide.

18 So just to get us started here,

19 USDA National Organic Program is responsible

20 for implementing the Organic Food Production

21 Act. It's a regulatory program. We have the

22 USDA organic regulations, or the National
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1 Organic Program regulations as some people

2 call them. But we've been using the term

3 "USDA organic regulations" because it's the

4 USDA organic logo that people see on products. 

5 And so that's what we think is a better way to

6 describe what the regulations are. And we,

7 the staff, are the National Organic Program. 

8 So that's our vernacular that we're using.

9 So the regulations include crops,

10 livestock, handling, wild crops, labeling,

11 certification, accreditation, National List,

12 all kinds of things really germane to the

13 National Organic Standards Board in

14 particular. We're also responsible for

15 accreditation and oversight of the -- about 90

16 authorized certifying agents that operate

17 worldwide. There's about 30,000 certified

18 organic operations. We're also responsible

19 for the various recognition and equivalency

20 arrangements to make sure that they're

21 properly implemented as well. 

22 And then compliance and
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1 enforcement, handling complaints, doing

2 investigation, civil penalties and the appeals

3 process. And then the National Organic

4 Standards Board is a very integral part of

5 what we do in terms of supporting the work of

6 the board.

7 So about a year and a half ago I

8 went over the 10 points of organic integrity. 

9 And I just want to give an update on how we're

10 doing on all these various aspects. So the 10

11 points of organic integrity as we've described

12 them, clear, enforceable standards,

13 communication, transparency, certification, a

14 complaint process, a penalty system, market

15 surveillance, unannounced inspections,

16 periodic residue testing and then a real

17 concept of organics is continual improvement. 

18 So on the first one in terms of

19 clear and enforceable standards the things

20 that we've accomplished. We continue to

21 implement National List recommendations. 

22 These are coming from the recommendations from
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1 the NOSB. 

2 We're almost done with Sunset

3 2012. We still have some things to do there. 

4 We have a residue testing proposed rule that

5 is out and then we are -- we've implemented

6 the pasture rule.

7 We still have to get the -- finish

8 work on sodium nitrate, vitamins and minerals. 

9 We have an interim rule out so we're still

10 working to get that to the final stage. 

11 Origin of livestock we're actively working on,

12 should have a proposed rule out next year. 

13 And aquaculture, mushrooms and pet food we're

14 also working on.

15 And then of course guidance. Both

16 products and seeds, we're working on final

17 guidance on those topics.

18 The pasture rule, just a little

19 bit about what we've been doing to ensure

20 implementation of the pasture rule. It's

21 about 2 years into the implementation. This

22 is the second full year of implementation of
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1 the pasture rule. We've done pasture visits

2 or witness audits in numerous states. It's

3 part of the regular part of our accreditation

4 audits. 

5 We've done over 50 accreditation

6 audits this year but we also do compliance

7 visits as well. So many states have been

8 included in this review of how they're doing

9 in terms of pasture rule implementation. 

10 What we've seen is that a number

11 of producers have expanded the amount of

12 pasture land that they have by either

13 converting crop land to pasture or by

14 acquiring more pasture. We've also seen

15 operations reduce their herd size to meet the

16 30 percent dry matter from pasture during the

17 grazing season.

18 We've also heard from certifiers

19 and producers that there is a significant

20 increase in record-keeping that's required to

21 meet the requirements for the pasture rule and

22 about a doubling in the inspection time. So,
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1 significant costs involved in verifying that

2 the pasture rule is being met. 

3 But I would say that it is working

4 in terms of having a verifiable method to

5 measure compliance with a pasture-based

6 standard. We can say that the standards do

7 require that all organic operations have a

8 pasture-based system and that the rule does

9 ensure that they all are required to meet

10 that. And that what we're also seeing is

11 general compliance with the pasture rule. 

12 There are certainly little problems here and

13 there but in general the organic producers

14 have adapted to meet the requirements of the

15 pasture rule.

16 The 2012 drought has been very,

17 very significant. There also was a

18 significant drought in 2011 but this year's

19 drought was the most severe since 1988. We've

20 gotten a number of requests for temporary

21 variances. 

22 This has been a very challenging
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1 thing for the program to figure out how do we

2 issue temporary variances that are fair and

3 consistent from year to year and from all the

4 different requests that we get. So we issued

5 a general temporary variance for all drought6 affected counties for non-irrigated land only

7 to reduce the dry matter intake from pasture

8 from 30 percent to 15 percent. 

9 And we're evaluating additional

10 temporary variance requests on either a

11 county-by-county or a producer-by-producer

12 basis. One of the ones that we're looking at

13 is a request to reduce the grazing period from

14 120 days down to -- one request is down to 90,

15 one is down to 80. So what are the criteria

16 that we use to evaluate that. And so that's

17 been a challenge for the program but we have

18 issued that temporary variance for all

19 drought-affected counties. 

20 Next slide shows the extent of the

21 2012 drought. So most of the United States is

22 affected except for the Northwest and the mid-
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1 Atlantic states and New England. So it's very

2 severe.

3 Okay, next point around

4 communication. We've done a number of things. 

5 Organic Literacy Initiative is something that

6 Mark Lipson will talk about in more detail, a

7 new initiative to get the word out about

8 opportunities in organic agriculture. We have

9 the newsletter that we publish on a consistent

10 basis, the Organic Insider, to try to keep

11 people up to date and improvements to the

12 website.

13 We still plan to do increased

14 outreach to increase the number of certified

15 operations so that they can get opportunities

16 of how to get into the organic marketplace,

17 improve the website more than we currently

18 have. This is just a part of the website that

19 takes you to learning more about other

20 resources in USDA that support organic

21 agriculture. There's a lot of information

22 there for lots of different programs. USDA
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1 has lots of services that can benefit organic

2 agriculture. 

3 A basic question is that this USDA

4 organic literacy helps users find information

5 on organic and organic-related USDA programs,

6 improves our customer service, helps farmers

7 and businesses determine is organic an option

8 for me. We're trying to get this out to all

9 counties in the U.S. because the USDA has an

10 active part in all counties in the U.S. 

11 Okay, moving onto transparency. 

12 We've posted an improved list of certified

13 operations. We still have a lot of work to do

14 there to have it be a realtime list of

15 certified operations but we've made some

16 improvements there. We're posting suspended

17 and revoked operations. We post fraudulent

18 certificates. 

19 Things that we still plan to do is

20 post certifiers' corrective action reports. 

21 That was done in the past. We just are trying

22 to make sure that that happens in a consistent
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1 and fair way. Posting cease and desist

2 letters that are issued as part of the

3 compliance process. 

4 And then increasing transparency

5 of NOSB members' interests. We've been

6 talking to the board about how to do this

7 that's not a burden to the members. We're

8 looking at what the Europeans do is they have

9 a form that's filled out called a declaration

10 of interests and it's made publicly available. 

11 And we're looking at some way that we could

12 have board members provide a declaration of

13 interest so there's a transparency that that's

14 provided to the public and to each other so we

15 can encourage transparency in all the

16 processes that we have.

17 Moving onto certification. As I

18 said we did over 50 audits of certifiers in

19 2012. What we find, there's a whole bunch of

20 audit criteria that are covered during these

21 audits and that there's 39 percent compliance

22 with those accreditation requirements. And
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1 then we also put an increased focus on

2 biodiversity. So there's numerous -- dozens

3 of different points that certifiers have to

4 meet and they're doing for the most part an

5 excellent job at meeting the accreditation and

6 certification requirements though there's

7 always room for improvement.

8 We've published through NCAT

9 developing organic system plans that can act

10 as a template for certifiers and operations. 

11 We've issued instructions to certifiers on a

12 penalty matrix and unannounced inspections. 

13 These are coming out of NOSB recommendations. 

14 Still planned is more publications on crops,

15 livestock, handling and certification through

16 NCAT. We're working on inspector

17 qualifications and grower group guidance.

18 And then classification and

19 permitted substances list for crops and

20 material review organizations. The

21 classification of permitted substances list

22 are in clearance so we should see those out
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1 within the next few months. But it's always -

2 - the clearance process is always this

3 mysterious process of how long it will

4 actually take.

5 Okay, complaints. We've opened

6 279 complaints. This is a 54 percent increase

7 from Fiscal Year 2011. We've also closed 279

8 complaints which is more than double the

9 number of complaints that were closed in

10 Fiscal Year 2011. So a lot of improvement in

11 terms of our handling of complaints to

12 increase the number of closed complaints,

13 investigations, by more than double this last

14 year.

15 We still plan to continue rigorous

16 investigations and improved case closure

17 rates. This just shows you complaint

18 distribution of where -- the types of

19 complaints that we get. About half of the

20 complaints are on uncertified operations,

21 people making organic claims that are not

22 certified. About one-third are labeling
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1 violations which can be having the lack of the

2 certifier name on the label or calling

3 something organic that's in the made-with

4 category. And then about one-sixth of the

5 violations are prohibited substances and

6 methods.

7 The other thing that is very good

8 for the program is that we've reduced the

9 average days to closure. For Fiscal Year 2010

10 we were at 269 days average from receiving the

11 complaint to closing the complaint, 2011 down

12 to 204 and last year about 80 days. So we've

13 made a lot of improvements there.

14 In terms of penalties which is an

15 important part in protecting organic integrity

16 we've issued nine civil penalties totaling

17 $120,000. The certifiers primarily have

18 suspended or revoked over 263 operations. And

19 we still plan to explore alternative ways to

20 enforce the USDA organic standards to the

21 fullest extent of the law. So we're looking

22 at other mechanisms that we can work with
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1 other USDA programs to ensure the integrity of

2 organic products and enforce the standards.

3 Market surveillance is an area

4 that we haven't had the resources to do much. 

5 We've done some compliance visits to a small

6 number of markets. So we still plan to

7 implement a market surveillance program

8 depending upon resources working with some

9 other AMS programs to potentially do that.

10 In terms of unannounced

11 inspections we published instructions last

12 month that certifying agents should conduct

13 unannounced inspections on about 5 percent of

14 the operations they certify. So this is an

15 NOSB recommendation that we've implemented. 

16 It also addresses one of the findings from an

17 OIG milk audit earlier this year.

18 We still plan to address this at

19 the annual training in January with the

20 certifiers to cover this to ensure that

21 they're properly implementing unannounced

22 inspections. And we'll evaluate the
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1 unannounced inspections during the future

2 compliance audits for certifiers.

3 For periodic residue testing we've

4 published the proposed rule. We published

5 instructions on responding to positive

6 residues, selecting labs and a targeted,

7 prohibited pesticides list. We still plan to

8 publish the final rule which actually should

9 be quite soon. And we'll have updated

10 instructions and ensure compliance through our

11 certifying agent audits.

12 And then in terms of continual

13 improvement we continue to expand on the

14 number of training webinars and modules,

15 audits with increased rigor, outreach

16 materials, National List sunset dates, and we

17 still plan to update our database of certified

18 operations, continue to do the annual training

19 of certifiers, make improvements there. And

20 oversight of international agreements is

21 something that we take very seriously and

22 ensure that that's happening properly with
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1 assessments of those agreements.

2 Also, a little update about peer

3 review. Peer review is required by the

4 Organic Food Production Act. We were working

5 with the National Institute of Standards and

6 Technology. They did a review of the program

7 in 2011. We've completed all the corrective

8 actions that were identified during that peer

9 review. That was a peer review that primarily

10 looked at the accreditation system and how the

11 program aligned with the requirements in

12 17011.

13 For next year we're planning on

14 working with the American National Standards

15 Institute that they'll be the ones that will

16 conduct a peer review of the program. And

17 we'll keep you informed of how that goes in

18 terms of the progress on that.

19 Office of Inspector General has

20 also been active in looking at the National

21 Organic Program. The 2010 audit that was the

22 extensive programmatic-wide review, there were
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1 14 recommendations. All of those have now

2 been addressed and closed. 

3 OIG, the milk audit phase I, there

4 were four findings. The corrective actions on

5 that are in progress. We've addressed the

6 unannounced inspections but still have work to

7 do on the other three findings. 

8 And then the OIG National List

9 NOSB audit, they completed their review and

10 they found no findings which is a testament to

11 the good work of the board in terms of

12 following procedures when reviewing petitions

13 and the whole process of making

14 recommendations to the National List. It's

15 very unusual for the Office of Inspector

16 General to have no findings so we were very

17 pleased to see that.

18 And I would say though that this

19 is something that we've talked to the board

20 about, that there's still room for improvement

21 in terms of the process of reviewing

22 petitions, technical reports, technical
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1 advisory panels. So it's nice that the OIG

2 had no findings but I still think that this is

3 something that the board and the program need

4 to work on to find improvements in that

5 process.

6 So how does this all fit into the

7 NOP's Strategic Plan? We have four major goal

8 areas around clear standards, making sure that

9 the standards are understandable for producers

10 and certifiers so that people know how to

11 comply. Consumer protection has to be our

12 number one priority in terms of protecting

13 organic integrity from farm to table. 

14 Market access both for export

15 markets but also for local and regional

16 growers, that they can get into markets, get

17 certified, have certification be affordable,

18 attainable and accessible. 

19 And then information technology. 

20 We really want to make some improvements in

21 that area. There's a lot we could do to

22 improve the database and information.
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1 So for 2012 our focus areas have

2 been Sunset 2012 to avoid the expiration, the

3 renewals or changes to over 200 substances. 

4 We still have a couple of things that are

5 pending, the sodium nitrate and vitamins and

6 minerals. We've also made amendments to the

7 allowed and prohibited substances. We've

8 addressed the expiration dates for methionine

9 and tetracycline. And then conducting

10 certification audits that are required to be

11 done every 2 and a half years. 

12 We've also worked on periodic

13 residue testing, pasture rule compliance,

14 penalty matrix, worked with FDA on the food

15 safety rules and organic standards, the

16 European Union trade partnership to make sure

17 that that's implemented effectively, Organic

18 Literacy Initiative and better communication

19 of actions and requirements. 

20 For 2013, Sunset 2013 has many

21 less substances than 2012 but it is a time22 sensitive issue. We have to have that
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1 completed by November of 2013 so we'll have a

2 proposed rule out on that sometime early next

3 year, right Melissa? Yes. 

4 Also origin of livestock, pet food

5 standards, aquaculture standards and

6 implementation of residue testing

7 requirements. So we're hoping to have

8 proposed rules out on all those top three

9 origin of livestock, pet food and aquaculture.

10 And then additional guidance

11 documents for organic seeds, grower groups,

12 made with organic. Organic in the brand name

13 is a policy that we're working on and

14 hopefully we'll have out in the next few

15 months. Inspector qualifications and handling

16 bulk organic products. And classification of

17 materials, permitted substances, as I said,

18 that's already in clearance.

19 Organic pet food. This is just an

20 example of why it takes such a long time for

21 the life cycle of a rule. So the first step

22 is a working group recommendation from the
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1 board. Then we get a final recommendation

2 from the NOSB. Then we have to put together

3 a proposed rule. We get public comments on

4 the proposed rule and then the final rule. So

5 that's part of the reason why it takes so

6 long. There's a lot of steps in the process.

7 But the other thing is that for

8 organic pet food if you think about it,

9 whether or not it's going to be economically

10 significant or not, how it relates to other

11 federal standards like FDA and the AAFCO

12 standards and the the whole issue of vitamins

13 and minerals and how they're unique to pets to

14 make sure that you have a full, balanced,

15 nutritional ration for pets. 

16 All those things have to be looked

17 at as we work on the proposed and final rule,

18 and that's part of the reason why it takes so

19 long. Also because we have many different

20 rules that we're working on with a really

21 limited number of staff. 

22 So for 2013 the focus areas are
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1 market surveillance, OIG milk audit part 2, we

2 should be seeing that sometime in the next few

3 months. Continued verification of

4 international trade partnership, additional

5 international market access. We're looking at

6 Japan in particular. Posting additional

7 audits and compliance information, list of

8 certified operations, stakeholder engagement,

9 NOSB support. So that's a brief overview of

10 all the things that we're doing in the

11 National Organic Program and things that we

12 plan to do in the upcoming year.

13 So I just wanted to quickly go

14 over what the board already knows, but just

15 wanted to review the OFPA requirements for the

16 criteria for handling ingredients and also the

17 specific requirements in the USDA organic

18 regulations. 

19 So OFPA permits exemptions if the

20 use of such substance would not be harmful to

21 human health or the environment -- of the

22 environment, is necessary to the production or
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1 handling of agricultural product because of

2 the unavailability of wholly natural

3 substitute products and is consistent with

4 organic farming and handling. So these are

5 the things that are looked at by the board as

6 you're looking at petitions, as you're looking

7 at things that would be potentially added to

8 the National List.

9 The National List is based on

10 those proposals from the National Organic

11 Standards Board and the program. NOP cannot

12 add a substance to the National List that has

13 not been recommended by the NOSB.

14 The evaluation criteria by the

15 board includes the potential for detrimental

16 chemical interactions with other materials,

17 the toxicity and mode of action of the

18 substance and of its breakdown products or any

19 contaminants and their persistence in areas of

20 concentration in the environment, and the

21 probability of environmental contamination

22 during manufacture, use, misuse or disposal of
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1 such substance. 

2 So that's a lot of stuff to look

3 at right there. And then it continues. Also

4 the effect of the substance on human health,

5 the alternatives to using the substance in

6 terms of practices or other available

7 materials, and its compatibility with the

8 system of sustainable agriculture. Again, a

9 lot of things for the board to look at and

10 consider in this matrix of criteria to

11 determine whether something should be added to

12 the list.

13 There's also additional criteria

14 for processing substances that are in the USDA

15 organic regulations and they include that the

16 substance cannot be produced from a natural

17 source and there are no organic substitutes. 

18 The substance's manufacture, use and disposal

19 do not have adverse effects on the environment

20 and are done in a manner compatible with

21 organic handling. 

22 The nutritional quality of the
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1 food is maintained when the substance is used

2 and the substance itself or its breakdown

3 products do not have an adverse effect on

4 human health as defined by applicable federal

5 regulations. It goes on to say the

6 substance's primary use is not as a

7 preservative or to recreate or improve

8 flavors, colors, textures or nutritive value

9 that are lost during processing except where

10 the replacement of nutrients is required by

11 law. The substance is listed as GRAS by FDA. 

12 We met with FDA, was it last week? 

13 And FDA doesn't like that term

14 because they do not list substances as GRAS. 

15 There's GRAS notifications. So we're working

16 with them to try to provide better

17 clarification on that. But the way it's

18 listed in the regulations is that the

19 substance is listed as GRAS by FDA when used

20 in accordance with FDA's good manufacturing

21 practices and contains no residues of heavy

22 metals or other contaminants in excess of
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1 tolerances set by FDA. 

2 And I think this is the final

3 point. The substance is essential for the

4 handling of organically produced agricultural

5 products. 

6 We also need to look at how these

7 substances have overlaps with other

8 regulations. The National List substances

9 must meet certain eligibility requirements. 

10 FDA or EPA must have authorized the substance

11 for the petition use in conventional

12 production or handling if applicable. So

13 that's what we have to do in terms of the

14 rulemaking for pet food or other topic areas

15 as well.

16 In addition to the FDA

17 requirements, non-organic ingredients and

18 processing aids must not be produced using

19 excluded methods, genetic engineering. And as

20 we're working with the GMO vaccine issue the

21 definition of excluded methods and how, for

22 instance, APHIS looks at genetic engineering
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1 may not be exactly the same so that's been a

2 challenge. Also ionizing radiation and sewage

3 sludge are also prohibited.

4 Okay, so we're celebrating 10

5 years of USDA organic. Mark Lipson is going

6 to cover that a little bit more. 

7 And then I also wanted to thank

8 Barry Flamm for his service to the board and

9 the organic community. If you've ever had a

10 chance to talk to Barry he's had an amazing

11 career and the stories he can tell are just

12 all over the map. 

13 When he was young he traveled

14 throughout the U.S. and has some wild stories

15 to tell of some of the places that we went and

16 the people that he encountered on the way. 

17 But then after that he had a career with the

18 Forest Service. 

19 He was on the National

20 Environmental Quality Board if I get that

21 correct during the Carter administration and

22 did a lot of really great work during that
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1 time frame. It was part of -- USDA had a

2 program for environmental quality and Barry

3 worked there until a change of administration

4 where that program was eliminated as I

5 understand. So Barry has contributed a lot to

6 the environmental cause over many decades and

7 I just want to thank you for your service and

8 your time, Barry.

9 (Applause)

10 MR. MCEVOY: Okay, and this is

11 just a picture of a biodiverse coffee farm in

12 Costa Rica that I thought would be appealing

13 to Barry showing lots of different vegetation. 

14 There's actually coffee in there somewhere but

15 also other, a polyculture of various crops. 

16 Okay and from there I think I'm

17 turning it over to Mark. Okay, for those who

18 don't know, Mark Lipson has been at FDA for 2

19 and a half years, came in to be the organic

20 policy coordinator for USDA. So he works

21 across all USDA agencies to promote and

22 support organic agriculture. So whereas the
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1 NOP focuses on the regulatory aspects of

2 things and he's a great support to us there

3 Mark gets to work with all the different

4 agencies, with APHIS on the GMO issues, with

5 crop insurance, with NRCS, many different

6 things. So Mark, thank you.

7 MR. LIPSON: All right. Thanks,

8 Miles. Good morning, everyone, thanks for

9 being here. Good morning, board members. 

10 As you know this month does mark

11 the 10-year tenure of the organic seal and the

12 national organic regulations. Do we know what

13 the first date of the use of the seal was? 

14 Somewhere like right around this week 10 years

15 ago. 

16 And a lot obviously has happened

17 in that time. The organic seal has become a

18 much bigger deal than anybody really could

19 have expected. And especially given the many

20 daunting challenges that we all face in making

21 this the program that we want it to be.

22 We had a brief celebration at the
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1 Department last week primarily to recognize

2 the staff members who have been working on the

3 NOP staff for much of this time. I think we

4 gave certificates to the folks who had been

5 there for more than 5 years as part of the NOP

6 and we had a wonderful home-baked cake from

7 Jenny Tucker. I loved it.

8 And the Deputy Secretary Kathleen

9 Merrigan, as you know one of the legislative

10 staffers who worked on the Organic Foods

11 Production Act and a former NOSB member and

12 Administrator of the Agriculture Marketing

13 Service at the time that the final rule was

14 promulgated wanted to send her regards to the

15 board and everyone attending to mark this

16 anniversary. 

17 So we're just going to go ahead

18 and roll this video that she taped to send her

19 greetings and feelings on this occasion.

20 (Video playing)

21 DEPUTY SECY MERRIGAN: Hello, NOSB

22 members and those of you in the audience. I'm
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1 Kathleen Merrigan, the Deputy Secretary of

2 Agriculture and maybe more important to this

3 day a former NOSB member. 

4 I served nearly 5 years and some

5 days I say to myself whoever thought a 5-year

6 term was appropriate. Doesn't it seem long to

7 you now that you're sitting in those seats?

8 I really want to first acknowledge

9 the incredible service that you provide as

10 NOSB members. I really personally do know how

11 many hours you devote to the work that's so

12 important to the organic community and to

13 consumers who care so much about the organic

14 label.

15 It's hard work and it's never16 ending work because from the very start the

17 people who birthed the organic movement, we've

18 always said that organic is going to be

19 constantly evolving. With new science, new

20 knowledge we're going to be in the process of

21 continuous improvement. So the work of the

22 NOSB is never-ending. That's good news, it
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1 really is, and so I just want to applaud you

2 for everything that you're doing. 

3 You're grappling with a lot of

4 tough issues but the Secretary and I appointed

5 you and we're confident in your ability to do

6 the job. So, thank you.

7 I also wanted to come albeit by

8 video today to celebrate the fact that we're

9 hitting the 10-year mark of the implementation

10 of the final organic rule. Time flies. 

11 I actually was out this morning in

12 Virginia. You can't see it but I'm actually

13 wearing jeans here at USDA because I was out

14 on a certified organic farm, really amazed by

15 what I was seeing in terms of innovations, so

16 thrilled that a lot of their food is going

17 directly into the schools and that the schools

18 are coming to visit the farm. We're really

19 into farm-to-school but we're also very into

20 school-to-farm. What a great way to start my

21 day.

22 And to know that we've had 10
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1 years of this rule in place which has provided

2 a strength and a credibility to the National

3 Organic Program that has allowed the industry

4 to grow and prosper. 

5 We just released on October 4th a

6 national survey of organic farmers and I

7 appreciate everyone who participated in that. 

8 That really provides a lot of important data

9 that was something that the Risk Management

10 Agency took on because they really want to get

11 the kind of data necessary to improve crop

12 insurance instruments for the organic

13 industry. 

14 They're just one of many agencies

15 at USDA. And what the Secretary and I have

16 said is that we're really proud of what the

17 National Organic Program is doing and we're

18 really glad to celebrate the 10 years of the

19 rule in place, but everyone in the house, all

20 of our different agencies, should be standing

21 up tall and helping the organic industry. 

22 In fact, our Strategic Plan at
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1 USDA calls for a 25 percent increase in the

2 number of certified operations between the

3 years 2009 and 2015. An audacious goal, but

4 if everyone around USDA does their part to

5 help organic farmers and ranchers and

6 processors we believe we will cross that

7 finish line.

8 We've had some incredible work on

9 my trade team opening up new doors in the

10 European Union and Canada. We have done some

11 important work with our colleagues in the

12 federal government, the International Trade

13 Commission, getting them to collect some

14 important data that you can now receive from

15 the Foreign Ag Service's website. 

16 We've been doing incredible work

17 in the research arena. That continuous

18 improvement? That means research in the

19 pipeline. We've seen over $100 million spent

20 on research. I remember a day when the

21 Organic Farming Research Foundation, Mark

22 Lipson came out with that report "Searching
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1 for the `O' Word" and it was less than one2 tenth of 1 percent of USDA research directly

3 pertinent to organic agriculture. Times sure

4 have changed.

5 So anyhow, I could go through and

6 catalogue all the different efforts that we're

7 undertaking here at USDA but we've got one8 stop shopping for you. If you go to our

9 website front page and hit "Results" you'll

10 see that among the handful of documents there

11 we have a results document for organic

12 agriculture. Please read it, please share it

13 with colleagues. We're really proud of the

14 work that we're doing. 

15 And the Secretary and I are really

16 very, very proud of our association with the

17 organic farmers and ranchers who are out there

18 innovating on the field every day. Good luck

19 with your meeting.

20 (End of video)

21 MR. LIPSON: Okay. And then I

22 have a few slides to add. 
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1 I'll just reinforce the depth of

2 commitment that the Deputy Secretary has of

3 course to this program and all of the work

4 that all of you are doing in organic

5 agriculture. 

6 As the Deputy mentioned the USDA

7 Strategic Plan -- first time there's ever been

8 anything like this -- calls for a numerical

9 increase in the number of certified organic

10 businesses in the U.S., 25 percent increase

11 between 2009 and 2015. 

12 So I'm just going to run over a

13 couple of things very quickly that we're doing

14 towards that goal. Implementation of the 2008

15 Farm Bill provisions for organic of which

16 there were a number of very important ones. 

17 My position was created in 2010 as an organic

18 policy advisor to the Secretary and to the

19 Office of the Secretary generally. 

20 I chair the Department-wide

21 Organic Working Group which brings together

22 members from all across the Department, from
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1 all the different agencies who have organic in

2 their portfolio either in a program or service

3 or interest within that agency. The working

4 group has a number of interagency projects

5 that it's working on trying to coordinate

6 efforts across the Department. And the most

7 notable example of that is the Organic

8 Literacy Initiative which Miles referred to

9 and I'll show you a little bit more about.

10 First of all, Farm Bill results. 

11 As the Deputy mentioned, over $100 million in

12 organic research and extension in the last 4

13 years. Many of those investments of course

14 are still in progress. We're just beginning

15 to see the actual results from that research

16 and extension work come out of the pipeline

17 and be available to producers and handlers. 

18 So this is a very, very significant area of

19 work inside USDA and people should be getting

20 involved with their researchers and extension

21 folks in their area to start utilizing those

22 results.
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1 This includes the e-Extension,

2 electronic extension service for organic, the

3 eOrganic. Another big accomplishment is in

4 terms of data that is available now to help

5 producers with financing and with business

6 planning. We've got a better baseline of data

7 about the organic sector and prices and

8 results that you can take to your banker than

9 we've ever had before. We know that this is

10 a significant barrier for many organic farmers

11 is being able to provide data for their

12 financiers.

13 We're making progress on crop

14 insurance. And this is related of course to

15 the data question. I'm going to talk about

16 that a little bit more in one second.

17 Certification cost-share, that is

18 support for producers and processors to bear

19 the cost of certification. Over $21 million

20 has been allocated from money that was

21 appropriated -- or required in the Farm Bill

22 in 2008. 
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1 Conservation program support to

2 this date explicitly for conservation

3 practices within the context of organic and

4 transitional systems, over $60 million. So

5 you can see that there's been almost an

6 exponential increase in resources devoted by

7 the Department to organic agriculture. And we

8 hope it's having impact. We know some of it,

9 we can measure some of it. Other parts of it

10 we won't be able to measure for some time.

11 Now, let me just say briefly as

12 the Deputy mentioned we just last week

13 released a new survey by the National

14 Agricultural Statistics Surveys of certified

15 organic producers. Just strictly certified

16 surveys was the object of this survey. It was

17 financed by the Risk Management Agency in

18 order to provide them with data necessary for

19 further improvements in providing equitable

20 crop insurance to organic producers. 

21 So primarily this data will be

22 used by RMA to implement what we call price
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1 election for organic producers, that is being

2 able to provide a payout price if you have a

3 loss that takes into account the actual market

4 value of the organic crops that were lost

5 instead of what has been the rule, that you

6 could only get paid out for the conventional

7 price because that was the data that USDA had

8 to work with. 

9 So you just go to the NAS website,

10 nas.usda.gov. It's a hundred some pages of

11 very granular data there. And I'll just point

12 out that this is not exactly comparable to the

13 2008 Certified Organic Production Census

14 Report because that had a wider list frame. 

15 That is, it included claimed organic,

16 producers who were exempt from certification

17 by virtue of being under $5,000 in sales and

18 transitional organic producers. So the two

19 reports don't exactly match up but there is

20 important data that can be drawn from both of

21 them.

22 And I'll just mention very briefly
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1 the situation with the Farm Bill programs

2 because I'm sure many of you are curious about

3 it. USDA is evaluating the implications of

4 the fact that Congress did not yet renew the

5 Farm Bill. Many of these programs that we're

6 speaking of have technically expired. 

7 Some of them continue in the

8 current fiscal year by virtue of the

9 Appropriations Bill that was passed which was

10 what they call a 6-month continuing

11 resolution. So some programs continue to

12 function even though their Farm Bill

13 legislative authority expired. Other programs

14 we're figuring out what the implications of

15 that expiration are right now. We hope that

16 that will be temporary but because many of

17 these things are interlocking it's kind of a

18 complicated process. So that's really all we

19 can say at this point is that we are closely

20 evaluating the implications for all these

21 programs and the impacts on the users of them.

22 So, a very important product to
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1 the Organic Working Group that several people

2 have mentioned, and I'm just going to say a

3 little bit more about this, is the Organic

4 Literacy Initiative. It helps users -- well,

5 you already saw this slide on Miles's

6 presentation. 

7 The basic impetus for this was

8 recognition by the Organic Working Group that

9 many people, many employees of USDA still did

10 not know in some cases that there even was a

11 USDA National Organic Program, in many cases

12 what the details were and how it worked. So,

13 the primary drive of this initiative is for

14 USDA employees. It's a training program to

15 try and ensure that all USDA employees, all

16 those field offices know about the organic

17 rules, what certification means, what it takes

18 to be an organic producer. So if somebody

19 comes in and says hey, I'm interested in this,

20 how can you help me they aren't just getting

21 a blank wall, or that the USDA employees are

22 better able to help them answer that question.
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1 One of the most important aspects

2 of this is the new USDA Organic Resource

3 Guide. This is the first time we've ever been

4 able to compile all the different resources

5 for organic producers and handlers in one

6 place. 

7 This is a reference tool for both

8 USDA employees and members of the public to be

9 able to try and find resources that are

10 helpful to them. And it's got contact

11 information for actual physical people and

12 their phone numbers and all the relevant

13 agencies. 

14 This is how the guide is

15 organized. It's basically a progression that

16 moves from most directly relevant, that is

17 direct support to organic producers and

18 handlers, moving outward to more general

19 programs that will occasionally be of

20 importance to a given organic producer but

21 also point out many useful resources that the

22 Department has that aren't necessarily focused
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1 directly on organic. 

2 In between there there's a section

3 on research and data and technical

4 information, and then marketing and

5 infrastructure. This is -- hopefully this

6 topical organization helps people find the

7 resources that they're specifically looking

8 for as quickly as possible.

9 And then there are two training

10 modules that are the result of this project,

11 Organic 101 and 201 that go into different

12 levels of detail about the program, about the

13 standards and about the other resources that

14 are available in USDA. 

15 And there's a version of this that

16 is specifically for USDA employees but they

17 are also public. So it's essentially the same

18 material, just in a different system for

19 access. 

20 And all this is bundled together

21 in what we call the Organic Literacy Toolkit. 

22 So we have the registries guide, the training
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1 modules and then these outreach materials as

2 the brochure and poster that are available for

3 USDA offices to use. 

4 But we think that will also be

5 useful for members of the organic community to

6 use in their own outreach to others. If

7 you're recruiting producers for your business

8 or you're trying to explain to your consumers

9 what organic is about, we hope that this will

10 be a useful tool.

11 So this is the message from the

12 Deputy that went with the organic literacy

13 materials. This is part of what's going out

14 to all USDA employees. Every part of USDA has

15 some responsibility for helping the Department

16 reach that goal and for assisting the organic

17 community.

18 Now, one primary example of that

19 that I want to show you, and this is just the

20 same slide that Miles showed you, but that's

21 the website there, "Organic Info" where all

22 these materials are housed.
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1 And so finally very briefly I'm

2 just going to talk to you about one of the

3 manifestations of the fact that organic is

4 relevant across the Department. One of the

5 crossovers has to do with the "Know Your

6 Farmer, Know Your Food" initiative which you

7 may know is the Department's effort to

8 coordinate resources across all the agencies

9 relevant to local and regional food systems.

10 What we call the Compass which is

11 the product of the "Know Your Farmer, Know

12 Your Food" initiative has two main parts. 

13 One's a narrative. It contains a number of

14 case studies, videos, explanation about the

15 different aspects of local and regional food

16 systems that USDA supports through its many

17 different programs. And when you look at that

18 narrative you'll note that many of those

19 projects feature organic producers and organic

20 businesses. 

21 And then the other main part of it

22 is this geospatial mapping tool which you see
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1 on the right of the slide there which actually

2 electronically maps all the projects that are

3 encompassed within the "Know Your Farmer, Know

4 Your Food" initiative. 

5 And this is just a slide of the

6 search that we did on the term "organic" with

7 the search function in this geospatial mapping

8 tool. Those are the projects that turn up

9 that have organic written into the text of the

10 project description or the project name. So

11 there's a very significant overlap here

12 between the "Know Your Farmer, Know Your Food"

13 initiative and the organic sector.

14 And then one of the great aspects

15 of this tool is that you can focus in on your

16 own community or region, look at all the

17 different things that USDA is supporting in

18 your area. You can find out where they got

19 their finding and then look at those programs,

20 see if that's appropriate for you. So it's a

21 great tool and we really encourage you to use

22 it. 
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1 So I'm just going to wrap up now

2 by coming back to the 10th anniversary. The

3 hallmark of the National Organic Program as

4 you all know very well is participation by the

5 entire community reflected both in the

6 composition of this board and the presence and

7 activity of all of you here. 

8 As a token of that we'd like to

9 invite everybody to during the time over the

10 next couple of days sign the posters that we

11 have in the back of the room here celebrating

12 the 10th anniversary. There is some special

13 silver-inked Sharpies that the staff would

14 like you to use because that's what it was

15 designed for. But we'd like to get everybody

16 to put their name on that and be part of

17 documenting this juncture for us.

18 So I can take a couple of

19 questions from the board I guess if we have

20 time, if we're running ahead. Otherwise I

21 will leave it there and let you get on with

22 your meeting. Thank you for your time and
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1 attention.

2 CHAIRPERSON FLAMM: Does anyone

3 have questions for Mark on the board? Mark,

4 do you wish to entertain any comments from the

5 audience?

6 MR. LIPSON: I think in the

7 interest of time we'll just, you know, go

8 ahead and keep moving.

9 CHAIRPERSON FLAMM: If there's no

10 comments then thank you very much, Mark. That

11 was a very interesting presentation. It's

12 wonderful to see such progress being made.

13 MR. LIPSON: Thank you all very

14 much.

15 (Applause)

16 MR. MCEVOY: Barry, yes, usually I

17 take questions from the board if there's any

18 particular questions on the presentation. So

19 I'm willing to answer any questions that the

20 board has.

21 CHAIRPERSON FLAMM: Miles is

22 willing to take any questions you have since
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1 we have a few minutes on the accreditation

2 process or anything else for that matter I'm

3 sure. So we do have a few moments if any of

4 the board members would like to follow up with

5 Miles.

6 I've never seen the board so

7 quiet, Miles. Thank you very much. We'll

8 take our break now and return at 9:45 when

9 we'll begin the public comment period. Thank

10 you very much.

11 (Whereupon, the foregoing matter

12 went off the record at 9:20 a.m. and went back

13 on the record at 9:48 a.m.)

14 CHAIRPERSON FLAMM: I believe

15 we're ready to begin the public comment

16 period. Michelle, if you would announce the

17 first speaker, please, and also who needs to

18 be prepared to come right up afterwards.

19 MS. ARSENAULT: Sure. So, Mark

20 Castel, you're up first and then Terry, you're

21 next on deck. And we have an on-deck chair up

22 here so as the first person begins if the
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1 second person could stand up here and be ready

2 so we can keep the public comment rolling

3 along at a nice pace. Thanks.

4 MR. CASTEL: Thank you, Mr.

5 Chairman. My name is Mark Allen Castel. I'm

6 the co-director of the Cornucopia Institute

7 and I act as their senior farm policy analyst. 

8 I'm a hired man. I work for farmers.

9 I recently heard an allegation

10 that the Cornucopia Institute was biased in

11 its research, especially the research we do

12 and the analysis for the National Organic

13 Standards Board. 

14 I'm here today to tell you folks

15 that these allegations are 100 percent

16 correct. We are biased. 

17 Our POV is based on two

18 presumptions. First, we feel that the Organic

19 Foods Production Act of 1990 should be

20 respected by the NOSB and vigorously enforced

21 by the USDA as Congress intended. And

22 secondly, we feel the work and deliberations
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1 of the NOSB should be based on objective

2 scientific review with an emphasis on public

3 research rather than being dominated by

4 corporate lobbying and self-serving industry5 funded research. So there you have it, guilty

6 as charged.

7 We believe in organics. We

8 believe the law should be enforced. But talk

9 is cheap. There are too many major

10 corporations and their trade groups that

11 profess their dedication and commitment to

12 organic integrity and then sell out the ideals

13 this industry and movement was founded upon.

14 So currently, so is the current

15 reality consistent with the letter of the law,

16 the spirit of the law and most importantly

17 consumer protection of the working definition

18 of the organic label? 

19 Do consumers think that 9,000-cow

20 dairy farms are what the organic label is all

21 about in the desert? It took years to get the

22 USDA to enact any kind of meaningful pasture
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1 enforcement language. And the byproduct? No

2 enforcement. And these CAFOs continue to be

3 allowed to bring in conventional cattle.

4 So now, 2012. Feed prices are

5 high and the factory farms are forcing

6 legitimate family organic farmers out of

7 business. This would be horrifying to our

8 most important stakeholders, our consumers. 

9 Is this horrifying to the growth proponents on

10 the NOSB? 

11 We need the NOSB to act like the

12 NOSB did. Please take the initiative and

13 promulgate new rules, preventing conventional

14 cattle from competitively disadvantaging

15 honest farmers. Don't wait for the NOP. 

16 Congress gave you the power to do this. 

17 Please use it.

18 Chickens. One hundred thousand

19 laying hens in one building with no access to

20 the outdoors. Illegal, but continuing to

21 operate. Plenty of ten and twenty thousand22 bird buildings with a few doors and no more
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1 than 1 to 5 percent of the birds ever outside

2 and porches. Illegal. This is not outdoor

3 access. And now the NOSB is proposing 2

4 square feet of outdoor access. Sorry folks,

5 that's a joke. 

6 Remember, the Europeans with a

7 larger commercial egg market for organics than

8 the United States requires 43 square feet but

9 their eggs are supplied by family-scale

10 farmers, not the giant CAFOs that the USDA in

11 action is supporting. So I'm sorry. 

12 Ask consumers what they think. 

13 They think organic birds are outside. We're

14 not going to fool anybody with 2 square feet. 

15 Whether it's factory dairy farms, fraudulent

16 feed, risky synthetic chemicals that are

17 approved for organic food. Are you asking for

18 more New York Times stories or maybe worse, 60

19 Minutes, seriously endangering the equity

20 we've all built in the organic label.

21 We risk the wholesale abandonment

22 of the organic label by many farmers and
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1 consumers. Who will invent the next

2 alternative farming vehicle? It's within your

3 power to prevent this from happening. Thank

4 you very much, Mr. Chairman.

5 CHAIRPERSON FLAMM: Thank you,

6 Mark. Questions for Mark from the board? 

7 Seeing no questions -- oh, sorry. Yes,

8 Calvin, address your question to Mark, please.

9 MR. WALKER: Mark, thanks for your

10 comments. What solutions do you see on some

11 of the things you expressed?

12 MR. CASTEL: Speak into the

13 microphone a little bit more, Calvin. I'm

14 sorry.

15 MR. WALKER: You mentioned quite a

16 few things. In a nutshell what are some of

17 the solutions that you see?

18 MR. CASTEL: Well, I'd like to

19 touch on two -- expand on two areas. One is

20 the law of unintended consequences. First we

21 started with these factory dairies and we're

22 proud at Cornucopia we've been able to shut
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1 some down. But others have not even been

2 investigated. Ten thousand cows on a farm. 

3 Obviously we have a competitive balance. 

4 It's the same macroeconomics that

5 forced conventional dairy farmers out of

6 business. The move to the West, the move to

7 industrial-scale dairy. 

8 But now the lack of enforcement,

9 rigorous enforcement on the propriety of

10 organics is pinching us in a couple of new

11 ways, Calvin. One is that the feed prices

12 have escalated along with conventional feed

13 exponentially. And what we have is wildly

14 profitable organic egg producers that are

15 really this industrial CAFO model with thirty

16 to hundred thousand birds per building. Some

17 of these outfits own 1 million birds. 

18 And it's so profitable in this

19 industrial setting that they are able to bid

20 up feed and force out of business legitimate

21 beef and dairy producers that cannot match

22 their deep pockets for procuring the feed. So
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1 we have organic dairymen and women cutting

2 back on how much grain they're producing,

3 cutting back on how much milk their cows

4 produce. And all the difference in the

5 market, when their milk production is cut back

6 it's all being made up by factory dairy farms. 

7 So this is a cyclical problem. 

8 It's putting certified organic family-sized

9 egg producers at competitive disadvantage. 

10 Simultaneously with putting dairy producers in

11 a competitive situation on the wholesale side

12 in terms of buying their feed.

13 And you might not think it's

14 directly related but the conflict of interest

15 provisions that you're going to deliberate

16 about right now have a direct involvement in

17 some of these decisions, whether they're a

18 chemical or whether -- how aggressively we

19 crack down on the abuses in organic livestock.

20 And I'll tell you, the macro

21 problem is that Congress created this board to

22 be an independent board with statutory
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1 authority very unlike other policy advisory

2 panels. And in an advisory capacity to the

3 USDA Secretary. Just like the Cornucopia

4 board of directors, and I'm happy one of our

5 board members is here so I hope I don't screw

6 up too badly, when we hire an auditor or when

7 the board deliberates as you're going to be,

8 you deliberate on either setting policy or

9 recommending policy. 

10 When the NOP staff and the USDA

11 come in and tell you how to do your job

12 they're usurping the authority that Congress

13 vested in you. You folks have to make the

14 decision whether conflicts of interest exist. 

15 If they don't feel that you're executing your

16 responsibilities within the framework of the

17 law that the USDA is incumbent to govern upon

18 then they have to tell you that. But to hand

19 over that authority to the USDA I think is

20 wrong and we're going to get more problems,

21 not less, in terms of conflicts.

22 CHAIRPERSON FLAMM: Thank you,
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1 Mark. Colehour, did you have a quick

2 question? 

3 MR. BONDERA: Thank you. I think

4 that I was primarily interested in hearing

5 about Cornucopia's perspective on conflict of

6 interest of addressing some of what you mostly

7 mentioned, the livestock issues and whatnot

8 and how revealing those conflicts of interest

9 might affect our decisions or impact our

10 process. But I feel like you may have

11 addressed that. But if you have something to

12 add regarding that detail.

13 MR. CASTEL: Well, the only thing

14 I would add, Colehour, is twofold. The

15 proposal that this deliberation by the NOP,

16 not the NOSB, be done in essence in secret and

17 that we may or may not know until after the

18 fact. And we won't necessarily know what the

19 conflict is. 

20 You know, we have always operated

21 in a transparent mode. That's why this

22 audience is here that not only represents
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1 themselves but like Cornucopia and the

2 National Organic Coalition have a wide

3 constituency of stakeholders. We need to have

4 the sunshine enter into this room. So the

5 transparency is one important thing.

6 The other is what constitutes a

7 conflict of interest. If at the last meeting

8 during the deliberations for carrageenan if an

9 executive whose company uses carrageenan,

10 whose company has sent representatives to

11 testify before this panel to appeal to you to

12 renew the status of carrageenan, that the same

13 company produces written commentary, the same

14 company's chief executive officer actually

15 called some of the NOSB members lobbying for

16 approval. 

17 And if this person doesn't take

18 the opportunity to recuse herself or that the

19 NOP doesn't rule that yes, there is an

20 economic interest for the employer who's

21 paying the paycheck of this NOSB, then maybe

22 it doesn't matter that conflict is going to be
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1 deliberated in public or private because there

2 is no such thing as conflict unless I happen

3 to be an entrepreneur and I manufacture

4 carrageenan. Maybe that extreme example which

5 probably will never manifest itself, maybe

6 that will be a conflict. 

7 So, I think that this is -- we all

8 bring some kind of conflicts. I used to be a

9 certified organic grower. If I was sitting on

10 the board and still growing I would bring some

11 conflicts. We're only asking that those be

12 disclosed and they should be disclosed at the

13 beginning of the subcommittee deliberations on

14 a material. And then it should be up to this

15 board to decide whether there's enough of a

16 direct conflict and a direct economic interest

17 that that individual should be encouraged on

18 that one issue to step down and not vote.

19 CHAIRPERSON FLAMM: Thank you,

20 Mark, for your comments. We're taking this

21 COI very seriously and we'll have further

22 debate on it. Some of the things you just
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1 mentioned I think we will be doing at this

2 meeting and we're going to -- but this is only

3 interim procedure so I appreciate your

4 comment. Thank you. 

5 MR. CASTEL: Thank you, Mr.

6 Chairman.

7 CHAIRPERSON FLAMM: Next speaker,

8 please. And please state your name and your

9 organization. 

10 MS. SHISTAR: Okay. My name is

11 Terry Shistar and I'm an ecologist working

12 with Beyond Pesticides.

13 I wanted to start by thanking you

14 all for devoting so much of your time and

15 energy to making the Organic Foods Production

16 Act work. Your role is really crucial and we

17 really appreciate it.

18 We've submitted comments on all of

19 the proposals under consideration at this

20 meeting and a summary of those is attached to

21 what I've just passed out. Our comments here

22 have to do with process at several different
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1 levels. We believe that the NOSB and the NOP

2 should be much more process-aware in carrying

3 out their missions.

4 On the level of governmental

5 processes we've been very concerned about the

6 turnaround on the conflict of interest

7 proposal. The COI process should be

8 transparent disclosure enforced by the NOSB. 

9 If there's a violation of federal COI laws or

10 regulations, or the NOSB acts outside of its

11 authority the NOP can step in citing

12 applicable laws and regulations.

13 NOSB must review all synthetic

14 substances before they are approved for use in

15 organic production. And we congratulate the

16 Inerts Working Group and the Crops

17 Subcommittee for producing a workable

18 proposal.

19 On the other hand, the options

20 presented in the discussion document on other

21 ingredients all fail to meet the requirement

22 to review all non-organic ingredients in
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1 organic products. 

2 The issue of biodegradable bio3 based bioplastic mulch probably could have

4 been better handled through a discussion

5 document rather than a proposal that

6 establishes the expectation that a decision

7 will be made without a thorough vetting of

8 many complex and scientific studies that have

9 been raised by commenters. These issues need

10 to be reviewed through a supplemental TR

11 before bringing the proposal to the board.

12 Organic infant formula would also

13 benefit from an issue paper that looked at the

14 classification of soy protein isolate, whether

15 mixtures of mostly synthetic materials should

16 be considered to be organic formula, and the

17 desirability of labeling any infant formula as

18 organic in light of negative impacts of

19 replacing breast milk with formula.

20 On the other hand, the omnivore

21 diets discussion document was a good example

22 of a discussion document that frames an issue
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1 in a broader context, allowing specific

2 alternatives to be elicited and considered

3 outside the debate of our proposal just prior

4 to board vote.

5 Finally, one process issue that

6 involves the interaction of the NOSB and NOP

7 with the rest of USDA is that of seed purity. 

8 The USDA must require terms and conditions

9 that are necessary for organic products to be

10 grown, sold and labeled in accordance with

11 OFPA. Given the threat to organic production

12 posed by the contamination by GE organisms

13 USDA must take actions to prevent that

14 contamination. 

15 A crucial process issue arose at

16 the Albuquerque meeting when the NOP announced

17 the potential issuance of guidance for

18 materials classification. This caused the

19 board to abandon the current policy adopted by

20 the board in 2009 and delay decisions about

21 classification pending publication and

22 adoption of the new guidance.
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1 Can the NOSB really do its job

2 without having any policy or guidance on

3 materials classification? We believe it was

4 a huge mistake on the part of the NOP to

5 undercut the board process by introducing an

6 outline of the guidance that differs

7 substantially from currently accepted policy

8 without consultation with the Materials

9 Committee, and an equally huge mistake on the

10 part of the board to delay decisions based on

11 the expectation of that guidance when the

12 board has policy on the issue.

13 Similarly we saw a striking

14 breakdown in process with the publication of

15 the September 12 memo on aquatic plants. 

16 Thank you.

17 CHAIRPERSON FLAMM: Does the board

18 have questions for Terry? I guess not. Thank

19 you very much.

20 Next speaker, please. And please

21 give your name and organization.

22 MS. HOODS: Leanna Hoods, National
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1 Organic Coalition. I want to thank you all

2 for all that you do. It seems as though your

3 job at each meeting is exponentially more

4 complex than the last and your dedication is

5 greatly appreciated.

6 My comments will be a bit global. 

7 You can see our written comments for the

8 details and ask me about them if you want. As

9 you delve into the deep weeds of organic we

10 ask you to keep your eye on the prize: organic

11 as an alternative food and agriculture system. 

12 Currently there are strong

13 advocates at the Agency, Miles, Mark, NOP all

14 together and certainly Deputy Secretary

15 Merrigan, but please remember USDA policy as

16 a whole is not friendly to organic as an

17 alternative system. So when NOP tells you

18 that they don't have the resources to complete

19 all the work that you move from this board we

20 respectfully request that you stay your

21 course. It is true in all of the regulatory

22 arms of government, EPA, FDA, USDA that they
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1 may not have enough resources to complete the

2 necessary regulations and there's intense

3 politics about that. 

4 But when NOC and others go to

5 Congress asking for more money for NOP

6 Congress members want to know what is on NOP's

7 desk that isn't getting done. Not NOSB, NOP. 

8 Obviously we're in some sort of purgatory or

9 hell of budget crises, but when dollars become

10 available that's how they'll get allocated.

11 But this is a lot more than

12 unachieved work plans of regulators. What you

13 do is to interface with the public perception

14 of the value of organic. What are folks

15 asking for in their food? It's too often

16 something relatively amorphous like local or

17 natural. Because of perceived issues of

18 integrity with the organic label organic is

19 not mentioned as the sustainable alternative. 

20 We must all change that because we

21 know organic is the only system with clear

22 definition and by the way transparent
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1 discussion of the standards. Nowhere else in

2 our food supply do we as citizens get to have

3 a say.

4 So, for the issue of inerts it's

5 vital that you proceed on an aggressive work

6 plan to review them all. It's bad for the

7 integrity of the label if this important piece

8 is stalled any longer. It says to the public

9 that organic still allows these dangerous

10 materials with some out-of-date blanket

11 approval. And by the way, rotenone is in that

12 category as well. 

13 And when the label looks bad the

14 entire organic system gets relegated to

15 characterization that organic is an expensive

16 label that doesn't do what it claims. Yet the

17 work that you do so heavily in the public eye

18 is the only instance where we as citizens and

19 you representing us citizens are determining

20 what goes into our food. Again I thank you

21 for that even when I disagree with you.

22 So here's some general specifics. 
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1 Don't allow material on the list if you

2 acknowledge that you don't know enough about

3 it, hoping that 5 years will get you more. 

4 The tendency in sunsetting is to leave a

5 material on which is not conducive to balanced

6 review. If you need to defer for another

7 meeting it's better than jumping in too fast.

8 We also believe in increasingly

9 sophisticated annotations. In this $30

10 billion industry new technologies are coming

11 along fast but need your oversight. And we

12 encourage the industry to look at what you're

13 doing and find the alternatives, for instance,

14 to EDTA as an inert of dubious safety.

15 Other ingredients, synthetic

16 nutrients in infant formula inerts,

17 antibiotics on tree fruits. Don't fall into

18 the trap that because bad decisions were made

19 previously you must uphold them. We support

20 option C on the other ingredients document

21 with some more protections.

22 You can't fix it all, but organic
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1 consumers don't like surprises. They do not

2 want to hear from the media about synthetics

3 in their organic food. They do want to know

4 that the label is transparent and that you are

5 transparent and that you have reviewed any

6 synthetics in organic.

7 This is what makes the difference

8 between the industrial food system and a truly

9 alternative organic food and farming system. 

10 So in all that you do embrace this

11 transparency and we thank you for

12 participating in such a democratic process.

13 I have handed out our aquaculture

14 letter that I had referred to in our comments

15 that discusses this. Thank you very much.

16 CHAIRPERSON FLAMM: Thank you,

17 Leanna. Does the board have comments for

18 Leanna? Yes, Nick.

19 MR. MARAVELL: Leanna, I noticed

20 in your written comments some indication that

21 perhaps not all organic products would have an

22 analogous conventional product to measure up
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1 to. In other words, the implication being

2 that just because we have a conventional food

3 product doesn't mean that we can produce an

4 organic product that is equivalent to that. 

5 Could you discuss that concept and how that

6 might limit or increase the desirability of

7 organic products?

8 MS. HOODS: Sure. In general we

9 absolutely agree that this board needs to be

10 careful in all areas that just because there's

11 a conventional product that you have to do

12 everything possible and approve as many

13 synthetics as possible to get to an organic

14 analogue on that.

15 Specifically we noted this in our

16 discussion of the infant formula

17 fortification. And it's very important there

18 because the entry point for organic is often

19 the mother's milk is the first, but mothers

20 looking for better food for their children is

21 really an important place. And they want to

22 know that the infant formula is not full of
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1 synthetics. 

2 Highly processed foods may not be

3 able to be organic. And I'll say in two areas

4 here on infant formula. I'm really confused

5 on the issue of soy protein isolate and

6 whether it's approved for use in organic. It

7 was my understanding it wasn't because it was

8 extracted with hexane and there's no other way

9 to get it. And so a soy formula for instance

10 may not be an appropriate thing for organic. 

11 The fortification issue in

12 addition fortifying with and using

13 preservatives, synthetic preservatives I don't

14 believe that organic consumers want to see

15 that. They want to see a whole food way to

16 meet those nutrient needs. And there are some

17 requirements in infant formula from FDA but

18 otherwise adding fortification, synthetic

19 fortification is not what organic is about. 

20 Therefore, if it means that you can't -- that

21 we can't have organic infant formula until the

22 industry finds ways that are compatible with
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1 the organic system then so be it. And that

2 will encourage the industry to grow using

3 organic methods and not trying to have

4 synthetics meet this.

5 So does that answer what you

6 needed, Nick?

7 MR. MARAVELL: Well, do you see

8 any way it could hurt the organic industry if

9 it's perceived that organic products are

10 limited in their ability to mirror

11 conventional products? Do you see any way

12 that could hurt?

13 MS. HOODS: That it could hurt to

14 not have a product, an organic product? 

15 MR. MARAVELL: Hurt the industry

16 in general, yes. In other words --

17 MS. HOODS: Well, I know that

18 mothers want to have an organic infant

19 formula, that's what they -- but they want it

20 to be something that's without synthetics. 

21 And so it could temporarily hurt the

22 marketplace but I would bet that if it's
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1 painful enough the industry will come up with

2 a way to make an organic infant formula that

3 is not made with hexane-extracted soy or

4 synthetic fortifications. 

5 And it would on the other side

6 really hurt the industry for mothers to really

7 understand how many synthetics and some would

8 believe unnecessary synthetics are used in

9 infant formula. So there's two sides to what

10 could hurt the industry.

11 CHAIRPERSON FLAMM: Thank you,

12 Leanna. Colehour, a quick question?

13 MR. BONDERA: Yes, thank you. 

14 Leanna, I want to ask you a question about

15 something you said that I wrote down. You are

16 transparent. And I think that when you said

17 that the suggestion was that related to the

18 transparency of our actions. And it struck in

19 me, and I think as the chair of the Policy

20 Development Subcommittee it struck in me this

21 whole conflict of interest question. 

22 And I wonder if the National
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1 Organic Coalition has something to say related

2 to how that transparency correlates with

3 conflict of interest topic. And I'm not sure

4 you do or if that was related to why you said

5 it, but if it is I would appreciate that. 

6 Thank you.

7 MS. HOODS: Yes, we made detailed

8 comments about that. And I may have come

9 close to standing on a table yesterday

10 screaming about it. But conflict of interest

11 policy, for all of us who have been on any

12 sort of board is as much about the disclosure

13 as anything else. 

14 And I think on boards, advisory

15 boards it's a significantly different

16 discussion than what regulators have to deal

17 with as paid staff who are regulators. That's

18 a discussion about -- that goes much deeper in

19 a lot of ways and is not -- and it's about our

20 belief in what our government is doing. It's

21 not particularly about -- not always entirely

22 about how it relates to the public. But you
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1 as an advisory board, it's about -- it's all

2 seeing how you make your deliberations.

3 And so first of all, as I noted in

4 my comments, whatever USDA Board of Ethics

5 decides that they think they must do, and I

6 would take some disagreement at what I saw in

7 the proposal, but whatever they decide they

8 must do you can still do your own thing on

9 conflict of interest and disclosure. 

10 And I think it brings a real

11 measure of accountability to each other as

12 colleagues and accountability to the public

13 when you all make some disclosures in the

14 public during these meetings related to each

15 of the deliberations that you're making. And

16 we can't prevent the conflict. We want there

17 to be some conflict in a lot of ways. So,

18 it's about everybody, you all understanding

19 from each other and us understanding as we

20 watch you where you're coming from on that. 

21 So to the extent that as much

22 disclosure is needed to get that across to us
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1 aids in all of us understanding and you being

2 accountable to yourselves and to us. So I

3 implore you to come up to -- I liked the

4 Albuquerque policy. I think it needed a

5 little more work but that you all have your

6 own policy and do your own disclosure on

7 conflict of interest. That's really, just a

8 really important thing.

9 CHAIRPERSON FLAMM: Thank you,

10 Leanna, for your comments and advice. We

11 appreciate that.

12 MS. HOODS: Thanks a lot.

13 CHAIRPERSON FLAMM: The next

14 speaker, please come up, give your name and

15 your organization, please.

16 MR. ROBINSON: Good morning. I'm

17 Bill Robinson, chairman of the board of BJE

18 Farms and Kreamer Feed, Nature's Best Organic

19 Feed.

20 I have three subjects this morning

21 I'll try to rush through. I feel there's no

22 more important issue facing the NOSB than the
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1 credibility of the organic meat, dairy, egg

2 and grain industries resulting from the

3 presence of GMOs in the grain supply.

4 The current position which I have

5 here from the NOP encourages the corruption of

6 integrity of the entire organic system which

7 consumes certified organic grains. It's like

8 a don't ask, don't tell policy. 

9 My company, Kreamer Feed, Nature's

10 Best Organic Feed, has been testing all

11 incoming corn, beans, soybean, meal for years. 

12 We stopped testing in 2012 due to the severe

13 grain shortages and the NOP's current position

14 on GMOs in grain. We simply could no longer

15 afford to be the only company that cares.

16 We have experience with Romer Labs

17 on qualitative testing which they call

18 AgriStrip for soybeans and meal. We have

19 experience with Envirologics Companies

20 quantitative tests for corn and soybeans, and

21 I can share those results with the committee.

22 Prior to the meeting we did test
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1 our organic seed corn and found it to be non2 detectable for GMOs. However, Envirologics

3 Companies told us that they have no test kits

4 available for rye or wheat seed.

5 I'd just like to offer our

6 experience and our company, our personnel any

7 way to the subcommittee, anything that we can

8 help in this policy development. I'll be here

9 all week and we'll be attending the other

10 subcommittee meetings.

11 On GMO vaccines, after Albuquerque

12 I ascertained that our company, BJE Farms,

13 uses 11 vaccines from 5 different companies in

14 our organic poultry production. Four of these

15 vaccines are GMO-based. One is the salmonella

16 vaccine we talked about in Albuquerque. It's

17 produced by the Fort Dodge Company. The

18 vaccine is critical to minimize the threat of

19 salmonella bacteria in organic eggs. The

20 organic egg industry of course cannot afford

21 a human illness or an outbreak of salmonella

22 caused by organic eggs.
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1 The other three GMO vaccines we

2 use are all produced by the Ceva Bioimmune

3 Company and they're used for broilers, turkeys

4 and young layers to protect them from various

5 diseases. They're technically given in ovo 3

6 days prior to hatching when they're

7 transferred from the incubator to the

8 hatchers. This procedure needs to be

9 clarified by the NOP as it looks at compliance

10 to the rule. Since the rule requires poultry

11 to be managed from the second day of life does

12 this violate that rule or technically is it

13 exempt? Currently I suspect some poultry

14 companies are also using antibiotics in ovo

15 because it seems to be allowed by the rule.

16 The last subject I have is on the

17 omnivore diets and methionine. Prior to

18 October we were allowed 5 pounds of synthetic

19 methionine in chickens, 4 pounds in layers and

20 6 pounds in turkeys. We're now allowed 2

21 pounds in layers and broilers and 3 pounds in

22 turkeys. This is a 50 percent reduction or
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1 more and now leaves us with synthetic

2 methionine at 1 percent -- sorry, synthetic

3 methionine is now allowed at one-tenth of 1

4 percent in the diet in layers and broilers,

5 and 15 one-hundredth of 1 percent in turkeys. 

6 I'm asking that the NOP give some

7 guidance to the certifiers as they calculate

8 compliance to this new rule because we're

9 really going to be working with some moving

10 targets here managing our flocks according to

11 their needs. Kind of like the way the

12 certifiers will be calculating the pasture

13 rule, they're going to have to calculate

14 compliance to that and I'd ask them to look at

15 total percent of the diet as opposed to the

16 hard and fast 2 pounds and 3 pounds.

17 I think I have a couple of seconds

18 left. I just urge the NOSB to allow the

19 omnivore diet because I think we're going to

20 need it with the reduced methionine levels as

21 another tool in our diet. I talk about like

22 fish meal, things like that that I'd like to
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1 see allowed.

2 CHAIRPERSON FLAMM: Thank you,

3 Bill. Is there questions for Bill? Mac has

4 a question for you, Bill.

5 MR. STONE: What are the feed

6 formulators doing around the reduction in

7 methionine, or what are the growers going to

8 see if it's not quite meeting that nutritional

9 need that they've been accustomed to?

10 MR. ROBINSON: We don't really

11 know. We just started as the rule took effect

12 a couple of weeks ago so I haven't heard

13 anything from the production side yet as to

14 what effects we've had from the change. But

15 we're just going to need all the tools we can

16 get and that's why I'd urge the omnivore

17 allowance or discussion moves forward and get

18 policy developed on that.

19 Because, you know, we've gone,

20 like I said, it's a pretty significant

21 reduction of methionine, over 50 percent in

22 the diets. I expect slower growth rates for
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1 one thing, effect on egg size in the layers,

2 slower growth rates in the turkeys and

3 broilers which in itself is just an economic

4 issue. That can be overcome. And we'll just

5 continue to monitor bird health and see what

6 effects we have there. Thank you very much. 

7 CHAIRPERSON FLAMM: Thank you,

8 Bill. 

9 MR. MARAVELL: Can I ask a

10 question?

11 CHAIRPERSON FLAMM: Can we call

12 Bill back?

13 MR. MARAVELL: Billy, I just

14 wanted to thank you for your remarks but also

15 to pick up on one that you made with regard to

16 vaccines in poultry products that were being

17 administered in ovo. And you were indicating

18 that you thought that that was an acceptable

19 practice because of the current USDA guidance

20 that poultry be managed from the second day

21 forward, second day of life forward

22 organically. Have you gotten any confirmation
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1 out of the NOP on that issue?

2 MR. ROBINSON: No, we haven't. We

3 -- it's not a practice that we do in our

4 operations but I just thought if the NOP looks

5 at that and says okay, it's currently being

6 allowed in antibiotics or allowed to be

7 injected in ovo, then is that setting a

8 precedent that in the future GMO vaccines

9 would be allowed to be administered in ovo

10 because it's happening before the first day of

11 life. So I just think it needs clarification

12 for the industry. 

13 MR. MARAVELL: So you say

14 currently you are not using eggs that have

15 been vaccinated.

16 MR. ROBINSON: No, we're not using

17 antibiotics. We are doing it with the GMO

18 vaccines in ovo currently. And that's

19 industry practice. That's why I just wanted

20 to get that out there to the committee so that

21 they could consider that in their policy

22 development.
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1 MR. MARAVELL: Thank you very

2 much.

3 CHAIRPERSON FLAMM: Thank you,

4 Bill. Next speaker, please. 

5 MS. ALLAN-FOSTER: All right, good

6 morning. My name is Robin Allan-Foster and so

7 in the interest of full disclosure, conflict

8 of interest, all kinds of potential and

9 perceived I was married a few weeks ago to Mr.

10 John Foster, a member of this board. So you

11 should know that.

12 (Applause)

13 MS. ALLAN-FOSTER: Thank you. So

14 I work as the director of quality farm and

15 global programs for CCOF Certification

16 Services out of Santa Cruz, California. We

17 are a non-profit organization founded in 1973. 

18 We'll be celebrating our 40th anniversary next

19 year. We invite you all to come join us just

20 prior to EcoFarm in January.

21 We're one of the oldest and

22 largest organic certification agencies in
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1 North America and we have over 2,300 certified

2 operations in 33 states in the U.S., Canada

3 and Mexico. 

4 So I'm here to make some comments

5 on the proposals and discussion documents put

6 forth from the Livestock, GMO, Crops and CACS

7 as I guess it is now known. I'll be brief and

8 broad because we did submit numerous detailed

9 written comments.

10 So regarding the Livestock

11 Subcommittee documents on omnivore diets for

12 livestock we do not support the consideration

13 of allowing mammalian or poultry slaughter

14 byproducts to be used for organic livestock. 

15 We believe synthetic methionine should

16 continue to be allowed until an alternative

17 natural source is found that could be produced

18 in sufficient quantities and acceptable

19 quality.

20 Regarding pet food amino acids we

21 do not think that materials for pet food

22 should be added to 205.603, the section of the
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1 National List reserved for livestock

2 materials, until the rest of the NOSB pet food

3 recommendation has been implemented. 

4 I understand that a version of the

5 proposal put forth publicly might not have

6 included relevant background information about

7 the committee's intentions on this. So if

8 that is true and I'm missing something I

9 apologize.

10 For the GMO Subcommittee regarding

11 seed purity we absolutely agree that GMO seeds

12 have no place in organic production. We are

13 concerned about a move away from process-based

14 certification to product-based certification

15 that would be determined by testing. Organic

16 producers already have to demonstrate that the

17 seeds they use were grown without the use of

18 GMOs. We believe that permitting producers

19 should be protected from GMO contamination and

20 that the financial and operational burden

21 should not be placed on the organic industry.

22 For the Crops Subcommittee
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1 regarding biodegradable mulch CCOF is

2 supportive of biodegradable mulch being

3 allowed in organic production. The continued

4 use of such significant amounts of non5 biodegradable plastic is counter to organic

6 values and principles of resource conservation

7 and recycling. We think that allowing such

8 biodegradable mulches would have a

9 significantly net positive effect on the

10 environment that is worth moving forward with

11 the allowance of it.

12 Regarding ferric phosphate this is

13 very important to many of our clients. We

14 believe it should absolutely remain listed and

15 allowed for use while an independent review of

16 EDTA can be conducted.

17 And finally, for the CACS

18 regarding biodiversity we just wanted to let

19 you know that we have as an organization taken

20 steps to implement the 2009 biodiversity

21 recommendations which have overall had a

22 positive effect and have been not terribly
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1 burdensome on us as a certifier or for our

2 farmer clients.

3 So that's all I have at this

4 point. Thank you and I'll open to questions.

5 CHAIRPERSON FLAMM: Questions for

6 Robin? Mac has a question for you, Robin.

7 MS. ALLAN-FOSTER: Sure, Mac.

8 MR. STONE: Robin, the annotation

9 on the biofilm talks about 90 percent

10 degradation or something. From a certifier

11 point of view what would you like to see so

12 that certifiers and inspectors can verify

13 degradation of the product without putting

14 undue burden on the grower or the certifier

15 for that matter?

16 MS. ALLAN-FOSTER: Well, the more

17 specific we can be about the requirement,

18 whether it's in an annotation or a definition,

19 however that is, you know, would go through

20 finally. We would expect that these materials

21 would end up being OMRI-listed or otherwise

22 reviewed and approved in a way that could be
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1 applicable so that farmers do not have to be

2 trying to determine it themselves every year

3 for each material.

4 CHAIRPERSON FLAMM: Thank you very

5 much, Robin, and congratulations.

6 MS. ALLAN-FOSTER: Thank you.

7 CHAIRPERSON FLAMM: Next speaker,

8 please. Please give your name and your

9 organization.

10 MR. SANDLER: Thank you, Mr.

11 Chairman. My name is Joe Sandler. I'm an

12 attorney for and appearing on behalf of Dr.

13 Bronner's Magic Soaps of Escondido,

14 California. 

15 Dr. Bronner's is the maker of the

16 nation's top selling natural brand of liquid

17 and bar soap in a number of varieties, all

18 certified, labeled, NOP-certified as made with

19 organic oils. And they also manufacture other

20 certified lotions, hair rinses and other

21 personal care products.

22 Dr. Bronner's appreciates this
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1 board's recommendation made nearly 3 years ago

2 that NOP initiate a rulemaking to make the NOP

3 standards mandatory for personal care products

4 labeled organic, and wanted to briefly update

5 the board on a couple of significant

6 developments.

7 We pursued litigation for nearly 4

8 years against makers of personal care products

9 making outright organic claims when their

10 products -- for products which no reasonable

11 consumer in the organic marketplace would

12 consider organic because the main cleansing

13 and moisturizing ingredients in these products

14 weren't derived from organic material and they

15 contained petrochemical compounds, synthetic

16 preservatives and so forth.

17 Also, in January 2010 Dr.

18 Bronner's filed an administrative complaint

19 against these same producers with NOP. The

20 court in the litigation dismissed the case on

21 the basis that only NOP has authority to

22 regulate in this area, even the labeling of
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1 personal care products, and no action has been

2 taken on the administrative complaint.

3 There have been a couple of

4 significant positive developments. First of

5 all, some of the defendants changed their

6 labeling practices to abandon any organic

7 claim. 

8 Secondly, there was issued the

9 ANSI/NSF Standard 305 for labeling of personal

10 care products which does not allow any

11 outright claim that a personal care product is

12 organic unless it meets the NOP 095 standard

13 but does allow a product to be labeled

14 "contains organic ingredients" even if it has

15 cleansing and moisturizing ingredients made

16 with some non-organic plant materials but

17 meets other standards.

18 Third, thanks in no small part to

19 the efforts of one of the members of this

20 board, Whole Foods modified its policy to

21 require that any product it sells labeled

22 outright organic or made with organic has to
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1 comply with NOP. But that policy does allow

2 the term "organic" or "organics" to be

3 included in a brand name even if it only meets

4 the contains organic ingredients standard of

5 the NSF standard. 

6 So where does that leave us? 

7 First, our products that remain in the mass

8 market and spa channels that are labeled

9 outright organic that comply with no standard

10 whatsoever. Secondly, there are products that

11 remain in the natural products marketplace

12 that have prominent organics claims in the

13 brand names but which are certified only to

14 the NSF standard that allows the main

15 cleansing and moisturizing ingredients to be

16 made from non-organic material. 

17 Our -- Dr. Bronner's is asking NOP

18 as an urgent priority simply to take action to

19 clarify that any personal care product making

20 an outright organic claim has to comply with

21 the NOP 095 standard. We don't believe it's

22 as important now to deal with made with
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1 organic claims and that just clarifying that

2 point as to outright organic claims but even

3 when contained in a brand name would not

4 require any protracted or lengthy rulemaking

5 because obviously would not require the board

6 or NOP to get into the weeds of allowances and

7 all of that.

8 So we hope that the NOSB will by

9 way of follow-up to its recommendation keep

10 this issue on the front burner and work with

11 NOP to address it as quickly as possible. 

12 Thank you very much, Mr. Chairman.

13 CHAIRPERSON FLAMM: Thank you,

14 Joe. Any questions for Joe? 

15 MR. SANDLER: All right, thank

16 you.

17 CHAIRPERSON FLAMM: Thank you very

18 much. Next speaker, please, and please give

19 your name and your organization.

20 MS. BAUMGARTNER: Hi, I'm Jo Ann

21 Baumgartner with the Wild Farm Alliance. I

22 had hoped to be here on Thursday to present my
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1 comments on biodiversity and natural resource

2 conservation but couldn't and so I'm giving

3 them this morning.

4 As you know biodiversity

5 conservation is in the NOP regulations. It's

6 part of the definition of organic production

7 that biodiversity must be conserved.

8 The preamble goes much further. 

9 It says that a producer must initiate

10 practices to support biodiversity and they

11 talk about compliance in how a producer must

12 incorporate biodiversity conservation

13 practices in the organic system plan.

14 Now, compare that with the natural

15 resources conservation part of the

16 regulations. Operators must maintain or

17 improve natural resources and the definition

18 is of natural resources soil, water, wetlands,

19 woodlands and wildlife. Soil, water,

20 wetlands, woodlands and wildlife. 

21 The NOSB twice now has said

22 biodiversity includes much more than that. It
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1 includes the variety of all life forms from

2 bacteria and fungi to grasses and insects and

3 mammals. It includes diversity from genetics

4 and species and populations, and also a range

5 of natural processes on which life depends

6 like water and nutrient cycling and predation.

7 We were really happy to see that

8 the NOP included natural resources -- soil,

9 water, wetlands, woodlands and wildlife -- in

10 the accreditation checklist this summer. We

11 think that biodiversity conservation needs to

12 be included in that.

13 The NOP also included in the

14 penalty matrix natural resources in three of

15 its four areas of violations. Again we think

16 biodiversity should be included in that and

17 that the fourth consideration where an

18 operators will actually get decertified needs

19 to address both biodiversity and natural

20 resource conservation. Right now it's only

21 soil and water.

22 So, for instance, an operator
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1 could have egregious soil erosion problems and

2 they might get decertified, but if they were

3 to, say, take out a wetland, kill all the

4 wildlife on the farm and, you know, annihilate

5 all the biodiversity they'd still be in

6 business.

7 Another question that came up in

8 the biodiversity discussion document was if

9 the handlers should be conserving biodiversity

10 and they are considered operators. They can

11 address this by if they have effluent there

12 they would use -- put in a constructed

13 wetland. They could put up raptor perches

14 around grain situations, buildings that have

15 grains and they could use landscaping that

16 protects water quality. 

17 Mother Jones a few years ago

18 published an article talking about how

19 thousands of acres of old growth forest in

20 Paraguay were cut down and then organic sugar

21 was grown in its place. And we feel like the

22 issue of converting high-value conservation
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1 lands into organic grow crops really needs to

2 be addressed.

3 And this is happening here in the

4 U.S. where prairies are being converted to

5 organic land. It's a marketing competition

6 issue. It's not fair that some growers have

7 to wait 3 years and then these growers are

8 just converting. And prairies can support

9 rare species that aren't protected like sage

10 grass that then maybe eventually will get on

11 the endangered species list if we all don't do

12 a better job.

13 Also, oak woodlands are getting

14 converted to wineries -- or I mean wine

15 grapes. And oak woodlands support lots and

16 lots of bird species. Thank you.

17 CHAIRPERSON FLAMM: Thank you very

18 much, Jo Ann, and thank you for the very good

19 work that the Wild Farm Alliance does. Is

20 there a question for Jo Ann? Jay.

21 MR. FELDMAN: Thank you, Jo Ann. 

22 Thank you for the work you do and Barry, thank
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1 you for your work on this discussion document,

2 the work of the subcommittee. This is

3 absolutely critical to organic and its growth

4 into the mainstream.

5 So, in light of all of this work I

6 guess what I would like to know if you could

7 succinctly tell us what you think the most

8 important next steps are in this area.

9 MS. BAUMGARTNER: Well, since the

10 NOP added natural resources to the

11 accreditation checklist and to the penalty

12 matrix they need to publish directions so

13 certifiers know what that means. 

14 And as you know we recorded

15 earlier at the last NOSB meeting that we

16 submitted a draft guidance for the NOP to

17 consider. But once the accreditation

18 checklist addition came out we realize that

19 guidance could take a long time. So we took

20 our guidance with broad-based support from

21 others and streamlined that to turn it into

22 instruction. 
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1 We'd love to see the NOP publish

2 instruction as soon as possible and then later

3 publish guidance. What the guidance doesn't

4 have and what's critical to incorporate is the

5 issue about high-value conservation lands. It

6 doesn't include definitions like biodiversity

7 conservation. It doesn't include the

8 definition of wetlands or riparian areas that

9 is part of the rule. So, first publish

10 instruction and then guidance.

11 CHAIRPERSON FLAMM: Thank you. Is

12 there any other question from the board for Jo

13 Ann? Thank you very much, Jo Ann. Next

14 speaker, please. If you would, give your name

15 and your organization.

16 MR. MALTBY: My name is Ed Maltby. 

17 I am the executive director of the Northeast

18 Organic Dairy Producers Alliance and

19 coordinator for the Federation of Organic

20 Dairy Farms. I also consult with the state of

21 Massachusetts over both organic and dairy

22 issues, and I assist with the management of an
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1 organically certified slaughterhouse in

2 western Mass. And I have three children and

3 one grandchild.

4 I'm going to jump first to the

5 origin of livestock rule even though this is

6 not before the NOSB but I never miss an

7 opportunity to push Miles and Melissa. If

8 there is a consideration of publishing just a

9 final rule we did have a proposed rule within

10 the proposed access to pasture which included

11 a lot of detail on the origin of livestock. 

12 Then moving to a final rule immediately with

13 a short comment period would have overwhelming

14 support from all sides of the industry,

15 especially at this critical time for organic

16 dairy farmers where they are selling excess

17 cows onto the conventional market and losing

18 fine genetics.

19 I truly appreciate the work of the

20 board members and know exactly how much time

21 they put into what they do and the level of

22 commitment on all sides no matter what
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1 discussion topics they're expected to be

2 experts on out in the field. And we've had a

3 very successful annual meeting with NODPA a

4 few weeks ago. You are very highly regarded

5 which is both good and an obvious burden

6 because they expect all the answers to come

7 from you rather than just recommendations to

8 an NOP that can take years to implement. So

9 thank you for your work and for your

10 protection of the integrity of the seal.

11 What we're facing in organic dairy

12 is we're losing organic dairy farms, we're

13 losing organic grain farms and that is the

14 economic reality. It is just not only because

15 of the high grain prices, it's because of the

16 increased costs and the lack of benefit,

17 economic benefit that dairy farmers find in

18 becoming organic. 

19 One of the issues that we have to

20 be very much aware of is how to balance the

21 needs of the scientific community, the

22 consumer and organic production. What may
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1 seem very necessary from a scientific point of

2 view, may have consumers jumping up and down

3 demanding it, may be impossible for the

4 organic production farmers to meet those

5 requirements within a set time. 

6 Organic production is based on a

7 long time of building fertility with dead

8 livestock. It's building genetics, it's

9 building immune systems, it's building an

10 economic pattern that can work which can't be

11 changed overnight. So in your considerations

12 of this moving forward we ask that you take --

13 you consider the operational side and then

14 consider it again. Because without organic

15 farmers you don't have anything to eat that's

16 organic except if it's imported.

17 And this year we have for the

18 first time organic powder being imported into

19 the Northeast, organic milk powder being

20 imported into the Northeast. The majority of

21 the grain that we used in northeast dairy

22 farms will come from Canada and from South
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1 America. And I had seven other things but

2 thank you.

3 CHAIRPERSON FLAMM: Thank you,

4 Edward. Do board members have questions for

5 Edward? Thank you very much. Next speaker,

6 please, and give your name and affiliation.

7 DR. HENDERSON: My name's Kent

8 Henderson. I am part of a six-person dairy

9 exclusive veterinary practice in Saint Albans,

10 Vermont. 

11 As my wife and I were driving down

12 from Vermont yesterday, we took a 6-hour drive

13 down. She asked exactly why are you coming

14 down to this Organic Standards Board meeting,

15 Kent? And I -- the reason I am coming down is

16 to tell you what is happening on Vermont

17 farms.

18 We're losing farms in the state of

19 Vermont. Ag is a very important part of the

20 way of life in Vermont but a strong point

21 that's growing is the number of organic farms

22 in our state. It's up over 200 farms now. 
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1 But as a practice we're seeing a threat to our

2 organic farms and I'd like to impress upon the

3 board that organic farms in Vermont are being

4 limited in their biosecurity programs in that

5 their vaccine programs are being held up by

6 having parasitization in the dairy farms, in

7 the grazing farms that I'm seeing.

8 Another part of this is what is

9 the public's perception of organic products

10 going to be if they realize that their

11 products are coming from animals that have

12 higher parasite loads than animals that can be

13 on grazing programs and the parasite loads can

14 be taken care of safely with a product that

15 has actually been approved by this board 6

16 years ago for the treatment of emergency

17 situations. It's a product that went through

18 USDA testing and came up with a zero milk

19 withholding time. So my clients are having a

20 hard time understanding what's the difference

21 and why can't I have these products. 

22 When I come to a farm and I see
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1 animals like this it's gone too far. I've got

2 fenbendazole to use now. Even with a 90-day

3 milk withholding time this animal is too far

4 gone. We had to put her down and this was

5 what I found when I opened the cow up. This

6 is the lining of her gut. These are the worms

7 in her gut.

8 What we did is for the last 4

9 years our practice has canvassed at least 100

10 farms, organic and non-organic. All of the

11 organic herds are heavily parasitized. The

12 long up and down column reveals that every cow

13 that was tested was positive for internal

14 parasites. The smaller box at the bottom says

15 every animal had 20 eggs per slide. 

16 And then I'm afraid my results are

17 covered up by the laptop up there, but what it

18 means is when we did the conversions we have

19 every cow making 80 pounds of manure,

20 spreading 80 pounds of manure in the pasture

21 every day. And she's transmitting almost

22 200,000 eggs, parasite eggs, every day she's
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1 on the pasture. So if you've got 50 or 100

2 cows on the pasture every day they're

3 transmitting millions of parasite eggs to be

4 picked up. So we cannot maintain properly

5 controlled parasites this way.

6 Fenbendazole is the product of

7 choice. It clears out of the animal in 72

8 hours. It is absorbed by the nematode. 

9 That's where the killing action takes care of

10 the parasite. When these parasite loads build

11 up it inhibits the TH2 helper cell that fights

12 off bacteria and viruses, therefore inhibiting

13 the effect of my vaccines. 

14 What we do with these de-worming

15 programs, I have to de-worm all the animals in

16 the fall to keep them clean through the

17 winter, and then in the spring I de-worm them

18 again. After I put them to pasture they pick

19 up over-wintered parasites' eggs and if we

20 take them out then we can keep the pastures

21 clean all summer so there's no re-infestation.

22 I have to do the whole herd. I
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1 have to reduce the 90-day milk withhold down

2 to a proper week. The 90-day milk withhold is

3 too long. It needs to be reduced to a week. 

4 Sorry for going over.

5 CHAIRPERSON FLAMM: Thank you very

6 much, Kent. Is there questions for Kent? 

7 Yes, Wendy.

8 MS. FULWIDER: Have any of these

9 producers used some of the alternative

10 treatments that are available and have they

11 been effective or not?

12 DR. HENDERSON: Yes. We've been

13 providing this information to our producers

14 for 4 years. I have seen the diatomaceous

15 earth tubs on their treatment cabinets and I

16 have not seen any reduction in worm eggs in

17 farms where these practices are taken care of. 

18 I have to tell you that I've had

19 three herds that the next year showed up with

20 absolutely no parasites on the farm. I did a

21 little questioning. I'm not a certifier, it's

22 not my responsibility. I have a vet-
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1 client/patient secret relationship but I can

2 tell you that those animals were de-wormed

3 with a non-organic improved substance. And I

4 think that may be where this is heading.

5 I have producers that are not

6 going into organic. They follow organic

7 processes in many things they do but they've

8 told me "I'm not going to go organic if I

9 can't de-worm my cattle." I've got a growing

10 number of producers that armed with this

11 information are thinking that way.

12 CHAIRPERSON FLAMM: Jean has a

13 question for you.

14 MS. RICHARDSON: Dr. Henderson, I

15 know that you're a big advocate of the use of

16 fenbendazole, for example, as a de-wormer. Is

17 there any new research that you're aware of

18 that's come up in the last few years since the

19 NOSB board looked at that that would help us

20 to have a better idea of how long fenbendazole

21 stays in an animal and if it does a better job

22 than Ivermectin, for example, and why that
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1 would be?

2 DR. HENDERSON: I would like to

3 refer you to our consultant that can answer

4 this, answer in-depth and we will in the

5 petition when we send it in. And it is Dr.

6 Don Bliss in Madison, Wisconsin.

7 I have this slide to show the

8 level of fenbendazole in the bloodstream. And

9 if you look at the bottom lining you can see

10 that it drops very, very quickly. You know,

11 in a matter of 4 days it has dropped down to

12 a nearly imperceptible level and I would have

13 to defer to a parasitologist, Dr. Bliss, to

14 tell you when it is totally gone from the body

15 system. But I'd have to refer back to the

16 USDA study where there was none found in the

17 milk.

18 CHAIRPERSON FLAMM: Thank you. 

19 Nick has a question for you.

20 MR. MARAVELL: Yes, actually I

21 have two quick questions. One is have you

22 done any of your work with meat animals or
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1 beef in this case. And the second question is

2 parasite loads can be greatly affected by

3 management practices. What -- if you had the

4 perfect world and all of your farmers had

5 access to the natural resources, land, water,

6 et cetera, that they needed what do you find

7 would be your recommendation for any change in

8 management practice? Or if you prefer to

9 answer that from the other side, what is that

10 limit -- what do you find is the most limiting

11 factor that is driving -- that then results in

12 driving these parasite loads up?

13 DR. HENDERSON: All right. First,

14 on the question about beef production, I have

15 very limited experience because I am from

16 northern Vermont. We have very few certified

17 beef organic herds. But I do have one herd

18 and he's in the process of de-certifying

19 because we have been running these PECs for 4

20 years. We cannot reduce the exposure level. 

21 We have lost calves. You know, they're losing

22 the calves. 
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1 And so he is insistent that he

2 wants to save his cattle. He's taken -- in

3 his view he's taking the high moral ground. 

4 He's taking the high moral ground in trying to

5 save his animals. He's grazing 100 animals on

6 1,200 acres and that is an excessive amount of

7 farm land. With the high cost of farm land

8 now in the Northeast I don't see how anybody

9 economically can do any better than that. So

10 he basically feels he's being pushed out of

11 the beef market because he cannot de-worm his

12 animals this way.

13 What I am seeing is my clients do

14 very well with grazing and with the high cost

15 of grain they're going to want to do more

16 grazing. This should work very well in

17 organic systems, but the type of grazing that

18 we're doing in the Northeast is we're making

19 the small paddocks, we're trying to put the

20 animals through these paddocks, you know, six

21 or seven times a year. Because of the high

22 cost of the ground we have to conserve it and
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1 move them through.

2 I think that in this case with the

3 safe, environmentally friendly product like

4 Safeguard or fenbendazole that is my best

5 solution economically for these farmers.

6 CHAIRPERSON FLAMM: Thank you very

7 much, Kent. Appreciate your comment. Very

8 valuable. Next speaker, please, and give your

9 name and your affiliation.

10 MR. O'NEIL: Good morning. My

11 name is Colin O'Neil. I'm the regulatory

12 policy analyst with the Center for Food

13 Safety. Good morning.

14 I'd like to talk on a couple of

15 different issues: conflict of interest,

16 biodegradable plastic mulch, omnivore diets

17 and biodiversity. 

18 First, CFS supports continued

19 efforts to update the NOSB's conflict of

20 interest policies and procedures. However, we

21 are perplexed by the turn to make COI

22 disclosures and the recusal process more
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1 opaque instead of more transparent. CFS does

2 not support allowing COI discussions and

3 evaluations to take place outside of the

4 public process and feels that the NOP should

5 not be the sole audience and arbiter of COI

6 decisions.

7 It is the NOSB's responsibility to

8 deliberate and decide upon the appropriateness

9 of their board members to vote on a given

10 issue at its public meetings. With the NOP

11 serving as a valuable advisor but risk losing

12 part of its independence as an advisory body. 

13 CFS also calls for the inclusion

14 of a COI requirement for all contractors and

15 consultants who conduct technical or TAP

16 reviews. We believe that a robust COI process

17 must require the inclusion of all researcher's

18 names and their COI disclosures in final

19 reports.

20 CFS does not support the allowance

21 of bio-based biodegradable plastic mulch in

22 organic production systems at this time. 
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1 While theoretically bioplastic mulch is

2 preferable to petrochemical-based mulch

3 research has not conclusively demonstrated

4 that biodegradation occurs or that it is

5 possible under all conditions, even if those

6 bioplastics conform to the ASTM standards.

7 We strongly urge the NOSB to not

8 consider biodegradation in the field to be

9 equivalent with removing plastic mulches at

10 the end of the growing season as per the

11 subcommittee document. Bioplastic mulch has

12 not undergone long-term soil testing in the

13 field to ensure that it does not negatively

14 impact agro-ecosystems. More research is

15 needed to ascertain how to facilitate

16 biodegradation under the different field

17 conditions that exist across the U.S. and to

18 evaluate the long-term impacts of bioplastic

19 mulch residues and dyes on cropping systems,

20 soils, biodiversity and wildlife.

21 CFS urges you to reject both the

22 petition and the proposed annotation at this
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1 time until outstanding issues surrounding

2 degradation and environmental impact can be

3 resolved.

4 With regard to omnivore diets, the

5 use of synthetic methionine allows organic

6 animal producers to speed growth and attain

7 higher profits. But this type of industrial

8 CAFO-type production is not consistent with

9 the spirit of organic. Synthetic methionine

10 can be eliminated from animal diets without

11 exposing the organic label to new risks posed

12 by using animal byproducts and slaughterhouse

13 wastes and feed which risk consumer confidence

14 and could also create unnecessary health risks

15 for animals and humans.

16 Natural sources of methionine must

17 be explored such as organic meat, worms,

18 insects, organically certified fish meal if

19 available in the future, corn gluten meal,

20 potato meal and dietary supplements derived

21 from organic and natural sources. Clear

22 research goals and a time line to identify
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1 safe alternatives are essential to permanently

2 eliminating synthetic methionine from organic

3 animal production at sunset.

4 On biodiversity, CFS supports

5 inspector and certifier trainings and the

6 development of guidance or instruction in the

7 NOP handbook to provide information on

8 biodiversity and natural resource

9 conservation. We encourage clarifications to

10 standardize inspection certification processes

11 to facilitate uniform implementation of

12 biodiversity conservation plans. 

13 CFS further urges the development

14 of a detailed protocol that puts restrictions

15 on conversion of high-value ecosystems into

16 organic farms. Therefore, we further support

17 the Wild Farm Alliance's recommendations to

18 involve certifiers in determining land

19 conservation value and assuring biological

20 monitoring of losses, and that appropriate

21 mitigation measures are taken if land is

22 converted. 
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1 Additional research is needed in

2 the areas of GMO vaccines, aquaculture and

3 antibiotics in tree fruits. And I'd refer you

4 to our written comments for more information

5 on that. Thank you.

6 CHAIRPERSON FLAMM: Thank you very

7 much. Questions from the board? Zea, please.

8 MS. SONNABEND: Hi, thank you. In

9 your organization's written public comment

10 Lisa Bunin uploaded a bioplastics document

11 that said "do not distribute" all over it and

12 was some sort of preliminary document or

13 something that was -- had a fair amount of

14 erroneous information in it, or

15 unsubstantiated information I guess I would

16 say. And I'm just wondering what that means,

17 do not distribute, and where did that come

18 from. And -- yes. Thank you.

19 MR. O'NEIL: So I think what

20 you're referring to is there was a colloqual

21 document about preliminary studies that are

22 currently being done on field tests of a
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1 number of the bioplastic mulches. That was I

2 believe at the time she published it was 12

3 months had been conducted, 12 months of study. 

4 Now the data is up to 18 months and there is

5 a final version of that and I'd be happy to

6 distribute that to all of you.

7 Really what that refers to is that

8 there isn't the solid data needed to move on

9 this issue now. What is in this final

10 document of 18 months, which still isn't the

11 full 2 years, is that there is zero

12 degradation in some sites in Washington to 90

13 percent degradation in the Texas site. And

14 that refers to the study of three different

15 climatic areas as far as looking at

16 biodegradation of those plastic mulches. But

17 I'd be happy to circulate that to clarify

18 that.

19 CHAIRPERSON FLAMM: Thank you. 

20 Jay had a question.

21 MR. FELDMAN: Thanks, Colin, that

22 would be helpful to circulate that because I
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1 too was interested in the data coming out of

2 that, the initial study at least.

3 You know, I guess CFS is not the

4 only organization that's asked the board to

5 delay. Organically Grown is another

6 organization that's looked at this as well. 

7 So, the challenge of course that we have,

8 there's a lot of interest in seeing us get off

9 the petrochemical-based plastic treadmill and

10 move to something. 

11 Do you think within some period of

12 time such as -- what would that be where some

13 of these questions would be resolved? Are we

14 talking about long-term research needed that

15 cannot be resolved for many years? Could you

16 put this in perspective for us in terms of the

17 time frame that you think would be required to

18 answer the questions that you and others have

19 raised?

20 MR. O'NEIL: Sure. I think on the

21 issue of bioplastic mulch, you know, namely a

22 number of folks who side with the not ready
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1 for prime time argument feel that not enough

2 field testing has been done to corroborate the

3 ASTM testing protocols which as we all know

4 are laboratory protocols, not real-world

5 conditions. They test optimal conditions. 

6 So, as you mentioned Zea, this

7 preliminary research that is now at 18 months

8 has shown really inconsistent results. So you

9 know, there may be optimal soil conditions in

10 Vermont, optimal soil conditions in Texas with

11 regard to temperature, soil moisture, you

12 know, the type of soil necessary. So as the

13 ASTM requires mixing of three different, three

14 or more soils to maximize biodegradation, that

15 may not be consistent across the U.S. 

16 So I think for us we would like to

17 see more research, more data, at least the

18 complete study of this 18-month study, bring

19 it to the full 2 years, so that we can know as

20 the NOSB is proposing, if the window is 90

21 percent degradation within a 2-year time span,

22 we should at least know that that has been
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1 corroborated, that 2-year time span. 

2 I understand that there are

3 additional studies coming out of Europe and I

4 think a number of us in the public and many

5 members on the committee may not be familiar

6 with those studies either. So I think it's

7 not a question of permanently delay. 

8 Certainly CFS wants to see us move away from

9 petroleum-based chemical products like this in

10 the organic standard. But we just need to

11 take a precautionary approach toward these

12 issues so that we don't have to back-pedal

13 later I think. So there is no clear time

14 frame but at least certainly corroborating

15 this 2-year window would be helpful.

16 CHAIRPERSON FLAMM: Thank you,

17 Colin. Colehour has a question for you.

18 MR. BONDERA: Yes, thank you. I

19 appreciate CFS's work on the topic you were

20 just speaking about but I'm not going to ask

21 about that because of time. 

22 So, what I do want to ask about is
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1 a comment you just made related to conflict of

2 interest and how you feel that -- CFS feels

3 that it shouldn't happen behind the scene I

4 think I jotted down as you spoke. 

5 And in my opinion from a

6 transparency perspective that makes sense. 

7 However, if a petition is received it's not

8 received -- even though it is public it's not

9 dealt with publicly. And so I wonder if you

10 could at least briefly address if you don't

11 think that the NOSB should be dealing with the

12 conflict of interest issue even if that isn't

13 done at these public meetings which is quite

14 a bit after, for example, like I said, a

15 petition is received. Or if you have any

16 suggestions for how we could or should best

17 handle conflict of interest as it affects our

18 consideration of issues prior to these public

19 meetings and then the vote. 

20 Because some of the discussion,

21 and I think that CFS is aware of this, has

22 been related to does a conflict of interest
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1 start at the very beginning so that there then

2 is consideration of whether or not somebody I

3 going to recuse themselves completely from

4 discussion and not just a final vote. And so

5 there's -- because there's different levels of

6 conflict of interest recusal processes. And

7 so if you could address that I'd appreciate

8 it. Thank you.

9 MR. O'NEIL: Sure. And I'll try

10 to address that, Colehour. But many of you

11 know my colleague Lisa Bunin who sadly

12 couldn't make it today. And we'd be happy to

13 send further comments on that issue to all of

14 you in writing.

15 You know, I think in short, yes,

16 certainly conflicts of interest arise at

17 multiple points throughout the process and we

18 certainly acknowledge that. At some points

19 maybe a conflict may not require recusal but

20 that may be apparent throughout the process. 

21 And I think really where we stand and many of

22 our colleagues stand is that the process
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1 should remain public and transparent and

2 should be a complete engagement with the board

3 so that the board can constantly be informed

4 by those conflicts as they do arise throughout

5 the process. That helps to inform the

6 conversation and I think the more information,

7 not less, can only inform transparency and

8 better governance. 

9 Also, as an independent advisory

10 body your independence is really informed by

11 your collective knowledge about your peers and

12 those potential conflicts that your peers and

13 colleagues may have.

14 CHAIRPERSON FLAMM: Thank you very

15 much, Colin.

16 MR. O'NEIL: Thank you.

17 CHAIRPERSON FLAMM: Next speaker,

18 please. Please give your name and your

19 affiliation.

20 MS. DIMATTEO: Good morning. My

21 name is Katherine DiMatteo. I'm with Wolf

22 DiMatteo plus Associates. We're a small
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1 consulting business. Our current clients

2 include members of the International Formula

3 Council and Biodegradable Products Institute.

4 Our written comments, and these

5 are all comments, are not made specifically on

6 behalf of any one client but do represent the

7 opinions of my partners based on our personal

8 values and experiences and our work with both

9 current and past clients.

10 First, we want to thank the Inerts

11 Working Group and Crops Subcommittee for their

12 recommendation. Although we had previously

13 recommended a different path forward we can

14 support what has been presented except for the

15 suggestion that all fit for 25(b) substances

16 of minimal risk be reviewed. We believe this

17 goes beyond the requirements of OFPA.

18 We urge the NOP, NOSB and/or the

19 working group to communicate extensively

20 during your tight time line with the input

21 suppliers in order to gather information and

22 inform them of deadlines.
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1 In terms of other ingredients

2 discussion paper. Substances that are

3 formulated with other ingredients, synthetic

4 or natural, and are reviewed during the

5 petition process can be and have been allowed

6 on the National List and in our opinion align

7 with the requirements of OFPA. This approach

8 should be continued with use of annotations

9 rather than individual review of such

10 substances. 

11 Thirdly, the organic label and NOP

12 seal are allowed on products with up to 5

13 percent non-organic non-synthetic and

14 synthetic substances. Don't sacrifice the

15 producers of the 95 percent organic

16 ingredients by overzealous interpretation of

17 review criteria based on personal opinion

18 about the essentiality of the 5 percent

19 substances or other concerns that fall outside

20 the scope of the National Organic Program such

21 as support for breast-feeding which is a

22 woman's choice issue and in many instances not
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1 an option for parents who adopt, for our gay

2 brothers and lesbian sisters, and for women

3 who have had breast cancer. 

4 Optimal nutrition based on sound

5 science and recommendations of nutrition

6 experts for those who cannot choose for

7 themselves such as infants and pets should be

8 a priority in determining the allowance of

9 synthetic and non-synthetic nutrients.

10 We appreciate the complexity of

11 reviewing materials and applying the criteria

12 required by OFPA and NOP regulations. We urge

13 you to not take an overly prescriptive

14 approach and be sure alternatives are widely

15 applicable, legally allowed and viable when

16 considering renewal or approval of materials.

17 Continuous improvement cannot be

18 forced through excessive regulation. It comes

19 from the organic process-based and holistic

20 management systems, from guidance, training,

21 models, mentors, from appropriate tools,

22 innovations and encouragement of individual
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1 motivation and commitment. 

2 The very existence of certified

3 organic farms, organic processing, the

4 National Organic Program and input and

5 ingredient suppliers who innovate compliant

6 materials has been continuous improvement from

7 business as usual in the farm and agricultural

8 product sector. 

9 Please provide producers with new

10 tools such as biodegradable mulch film and

11 also the time to find alternatives to rotenone

12 by imposing a restrictive annotation in line

13 with the Codex guidelines for organic rather

14 than a complete prohibition at this time.

15 Lastly, although I have heard that

16 there are some organic supporters and

17 organizations that no longer believe that it

18 is important to increase the number of acres

19 in organic production we still stand behind

20 this goal as a means to sustaining our natural

21 resources and a liveable and healthy

22 environment. Thank you.
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1 CHAIRPERSON FLAMM: Thank you,

2 Katherine. Questions for Katherine? Thank

3 you very much, Katherine. Next speaker,

4 please, and give your name and affiliation.

5 MS. BEDROSIAN: Hello. My name is

6 Carol Bedrosian and I've been publishing the

7 Spirit of Change holistic magazine in New

8 England for 26 years. 

9 I recognized long ago that food is

10 my best medicine and the healthiest food I can

11 eat is fresh, organic, local, non-GMO and

12 preservative- and pesticide-free. My mission

13 through Spirit of Change is to inform the

14 public about food as medicine, including

15 awareness of which ingredients to avoid.

16 I'm also a member of the

17 Cornucopia Institute and here today as a

18 citizen lobbyist. My original presentation

19 time was for tomorrow but due to a funeral I

20 was rescheduled today. Thank you for your

21 accommodation.

22 When taxpayers have already funded
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1 research and consensus within the scientific

2 community already exists why should this board

3 request research on basic questions that have

4 already been answered? That food-grade

5 carrageenan predictably causes

6 gastrointestinal inflammation has been

7 accepted by the scientific community. This is

8 not considered controversial other than by

9 scientists employed by the companies that

10 profit from the continued use of carrageenan

11 in foods.

12 In the Journal of Nutritional

13 Biochemistry in 2010 the first line of this

14 peer-reviewed study states, "The common food

15 additive carrageenan predictably causes

16 intestinal inflammation in animal models." 

17 The aim of that study was to

18 identify the particular pathways by which

19 food-grade carrageenan causes inflammation. 

20 Authors include Dr. Sumit Bhattacharya,

21 professor at the University of Illinois at

22 Chicago's College of Medicine, Dr. Robert
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1 Linhardt, senior constellation professor at

2 Rensselaer Polytechnic Institute, and Dr.

3 Gerbin Michelle of the French National

4 Scientific Research Center in the Sorbonne in

5 France.

6 These M.D.'s and Ph.D.'s have

7 accepted that the food-grade additive

8 carrageenan predictably causes intestinal

9 inflammation in animal models. They moved on

10 to find out if they could identify the

11 specific ways in which this happens. The

12 results of their experiments have been

13 published in peer-reviewed academic journals.

14 The American Diabetes Association

15 is funding research after a connection was

16 found between the consumption of food-grade

17 carrageenan and insulin resistance in

18 laboratory animals. Results from the initial

19 studies were confirmed by studies performed at

20 Vanderbilt's Mouse Metabolic Phenotyping

21 Center that small amounts of food-grade

22 carrageenan lead to glucose intolerance and
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1 insulin resistance in mice. After a study

2 using human subjects suffering from ulcerative

3 colitis is currently underway at the

4 University of the Chicago Medicine School.

5 The funding for this research

6 comes from the broad medical research program

7 headed by Dr. Daniel Hollander, professor of

8 medicine at the UCLA School of Medicine. All

9 these physician scientists from the Sorbonne

10 to the University of Chicago to the UCLA

11 School of Medicine have accepted that

12 carrageenan causes intestinal inflammation. 

13 Again, a direct quote from a peer14 reviewed abstract authored by Dr. Stephen

15 Hanauer, chief of gastroenterology and

16 nutrition at the University of Chicago's

17 Medical School. The common food-grade

18 additive carrageenan produces inflammation in

19 animal models of colitis and activates

20 inflammatory pathways in cultured human

21 colonic epithelial cells. Yet a majority of

22 the NOSB decided that this research and these
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1 researchers are, quote, "not believable." 

2 Then as if to rub salt in the

3 wounds of these researchers the Materials

4 Subcommittee put carrageenan on its list of

5 research priorities. Opinion leaders like Dr.

6 Andrew Weil and respected institutions like

7 the Rodale Institute are urging people to

8 avoid carrageenan. 

9 We urge you to respect the

10 scientific community and remove carrageenan

11 from your list of priorities, and we would

12 urge the board to vote for reconsideration of

13 carrageenan's approval. Thank you.

14 CHAIRPERSON FLAMM: Thank you,

15 Carol. Is there questions by the board for

16 Carol? 

17 MS. BEDROSIAN: Thank you.

18 CHAIRPERSON FLAMM: Thank you very

19 much, Carol. Next speaker, please. 

20 MS. ARSENAULT: It's Bradie

21 Metheny.

22 CHAIRPERSON FLAMM: Please state
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1 your name and affiliation for the record.

2 MR. METHENY: Hi, I'm Bradie

3 Metheny. I live in South Dartmouth,

4 Massachusetts. I'm here as a citizen advocate

5 for Cornucopia which I'm sure you all know is

6 a 7,000-member non-profit. We look at it as

7 sort of a safeguard for those of us who are

8 interested in organics and use it as a way of

9 getting things certified and safety. 

10 Organics is really our safe haven,

11 particularly for those of us who are only

12 organic consumers and we'd like to keep it

13 that way. The last thing we want is to see

14 the same corporations that pollute

15 conventional food supplies to chip away at the

16 meaning of the word "organic."

17 Folks like me depend on the

18 organic label. We don't know everybody's

19 background, we don't know everybody that's

20 involved, but if it has an organic label we

21 assume and largely because of your effort that

22 it's safe so we don't need to know all the
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1 rest.

2 The very basic idea that without

3 your guiding and without your view organics

4 can suffer. We can suffer. We can lose

5 faith. And for those of you who are dependent

6 upon trying to get the area to grow it's that

7 trust between the organic farmers and the

8 consumers that is so very important.

9 For every material input or

10 ingredient used in agriculture and food

11 production today there is a manufacturer or

12 trade association often joined

13 enthusiastically by its customers that will

14 use whatever tactics necessary to defend the

15 products and their safety and efficacy. 

16 It's deeply disturbing when this

17 board when voting on petitions or sunset

18 reviews for material discounts independent,

19 publicly-funded research and instead depends

20 heavily on industrial testimony and

21 industrial-funded research, ignoring the

22 precautionary principle. 
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1 Siding with a corporate lobby that

2 has a financial interest in your vote

3 certainly does destroy confidence all the way

4 around, not only in the board but also in the

5 whole organic idea. We all pay a price when

6 that happens.

7 The point that we can reach for

8 food products during the organic label, and

9 rest assured that everything in the input on

10 the farm, and every ingredient in the product

11 has been carefully reviewed and approved as

12 essential, not environmentally harmful and

13 safe to our health. That is the basic

14 expectation that we, the consumer of organic

15 foods, has, and it's that expectation that's

16 rooted in the organic law that we feel must be

17 respected by you all.

18 We hope that going forward this

19 board will vote with integrity on issues like

20 ferric phosphate, biodegradable bioplastic

21 mulch, synthetic so-called nutrients and

22 synthetic preservatives for infant formula,
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1 synthetic nutrients in pet food and all other

2 issues that you'll be discussing this week. 

3 We think that your discussion -- I

4 think that the discussion that you're having

5 on the conflict of interest and when people

6 should recuse themselves is probably one of

7 the most important discussions you can have

8 and have it before the situation arises.

9 One of the things that the board

10 has -- thank you. 

11 CHAIRPERSON FLAMM: Thank you,

12 Bradie. Questions from the board for Bradie? 

13 John Foster, please.

14 MR. FOSTER: I think it's a pretty

15 straightforward question. Who should have

16 access to organic food in your opinion?

17 MR. METHENY: Who should have ask

18 access to organic food?

19 MR. FOSTER: Yes.

20 MR. METHENY: I think everybody

21 should have access to organic food.

22 MR. FOSTER: Awesome. Thank you.
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1 MR. METHENY: I mean, I really do. 

2 Thank you.

3 CHAIRPERSON FLAMM: Is there

4 another question for Bradie by any board

5 member? 

6 MR. METHENY: Thanks again and

7 thanks for your time being out here. We

8 appreciate it.

9 CHAIRPERSON FLAMM: Thank you for

10 your comments. The next speaker, please. 

11 Please give your name and affiliation.

12 MS. CZERNICKA: Good morning. My

13 name is Susan Czernicka and I've been a

14 psychologist practicing in Massachusetts for

15 30 years mostly with children and families. 

16 I've spent time at Childrens Hospital and

17 worked for a number of years with the early

18 intervention program.

19 I'm a member of the Cornucopia

20 Institute and here today as a citizen

21 lobbyist. I volunteered to present testimony

22 because I want to ensure the integrity of
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1 organic food.

2 I'd like to speak about organic

3 infant formula. Cornucopia was pleased to see

4 the unanimous decision by the subcommittee to

5 reject the petitions for ascorbyl palmitate

6 and betacarotene which serve as preservatives

7 in infant formula. I would like to present

8 additional reasons why these materials should

9 be rejected.

10 The organic standards specifically

11 prohibit synthetic preservatives and they also

12 prohibit synthetic ingredients that are not

13 essential or potentially dangerous to human

14 health. These two materials preserve other

15 ingredients in formula, especially DHA and ARA

16 that are themselves not defined as essential. 

17 In fact, there are serious concerns about the

18 safety of DHA and ARA in infant formula which

19 were ignored when this board voted by a one20 vote margin to approve these materials at the

21 fall -- at its fall 2011 meeting. 

22 When these oils were first added
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1 to infant formula healthcare professionals

2 started noticing symptoms like diarrhea,

3 vomiting and bloating in formula-fed infants. 

4 These symptoms would disappear often overnight

5 when the infant was switched to formula

6 without Martex-patented DHA and ARA. The FDA

7 received hundreds of reports of these adverse

8 reactions to formula with DHA and ARA. 

9 In fact, FDA data shows that the

10 incidence of complaints related to, quote,

11 "bloating and distension," end quote, in

12 formula-fed infants rose from zero percent of

13 adverse reaction reports in 2000 when DHA and

14 ARA were not yet added to formula to nearly 10

15 percent in 2009 when DHA and ARA were present

16 in nearly all formula.

17 DHA and ARA are added as marketing

18 tools. All three meta-analyses studies on the

19 issue have looked at whether these ingredients

20 benefit infant cognition and visual

21 development, and all three have determined

22 that no benefit exists. 
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1 Cornucopia and other groups like

2 the National Alliance for Breast-feeding

3 Advocacy and the California WIC Association

4 has for years advocated against DHA and ARA in

5 formula because these ingredients do much more

6 harm than good. Formula makers advertise

7 these ingredients as, quote, "naturally

8 occurring in breast milk," end quote, which

9 misleads mothers into thinking that formula

10 contains natural ingredients and that it is

11 equivalent to breast milk. Nothing could be

12 further from the truth.

13 The DHA algal oil in formula is

14 structurally different from the DHA in breast

15 milk. Breast milk contains hundreds of

16 additional nutrients that are not found in

17 formula. The balances of these nutrients can

18 change daily depending on the infant's needs. 

19 Breast milk is alive with antibiotics and

20 probiotics that formula, a highly processed

21 and dead food, simply cannot match. 

22 I am asking first and foremost
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1 that no additional synthetic ingredients be

2 approved. None of them are healthy, proven to

3 be beneficial or produced in accordance to

4 organic standards. I'm also asking that you

5 seriously consider whether any formula,

6 especially soy-based formula, should carry the

7 organic label. The organic label on formula

8 suggests to new mothers that the product is a

9 natural, clean, wholesome food for their

10 child. It isn't. And the more synthetics the

11 formula makers add in their attempts to mimic

12 breast milk the further away they get from

13 providing safe alternatives to mothers who

14 have no alternative. Please reject all the

15 petitions on the agenda today.

16 CHAIRPERSON FLAMM: Thank you,

17 Susan. Any board member have a question for

18 Susan? 

19 MS. CZERNICKA: Thank you.

20 CHAIRPERSON FLAMM: Next speaker,

21 please, and give your name and affiliation.

22 MS. WALDEN: My name is Jessica
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1 Walden. I'm with QAI, an organic certifier. 

2 We represent a diverse and varied

3 client base and so our perspective really is

4 of really hoping that the standards in

5 guidance documents become clearer so that our

6 jobs are easier. We're not really advocating

7 one way or the other for whether or not a

8 material should be allowed or not.

9 We recognize that the organic

10 standards is an evolution process and we're

11 happy to be a part of it. We thank you very

12 much for your work.

13 We partook in various task forces

14 during this process with the OTA as well as

15 the ACA task force on the issues of other

16 ingredients, biological diversity and

17 calculation of organic ingredients. 

18 On the issue of other ingredients

19 we participated with the OTA and the document

20 that came out of that discussion sums it up

21 nicely in that it's a very complex issue and

22 one that deserves a lot of attention from the
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1 NOSB. We feel that the decision or the

2 criteria by which certifiers are to review

3 whether or not a material allowed in organic

4 product and that material containing those

5 other ingredients or incidental additives. We

6 would ask that the NOSB please develop

7 procedure to carry out the review of those

8 incidentals. 

9 And that requires a full review of

10 those materials and the incidentals that could

11 exist in those materials as well as the

12 functionality of those incidental ingredients,

13 whether or not they're essential for that

14 material to work, and also whether or not

15 there are alternatives. And then after that

16 review process, developing very clear, concise

17 annotations so that certifiers can carry out

18 their job.

19 Historically the NOSB, that was

20 the job, the function of the NOSB and

21 certifiers definitely go to old TAP reviews to

22 try to work out whether incidentals are a part
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1 of that review process or not.

2 However, the sort of success of

3 the other ingredients document also is

4 dependent upon clear definitions of the

5 classification of materials. So whether or

6 not something is classified as synthetic or

7 non-synthetic, agricultural or non8 agricultural. So those two go hand in hand.

9 With regard to the calculation of

10 ingredients we worked with the ACA to develop

11 comments. And it looks like there's a lot of

12 consistency but if you look at the ACA

13 document under Section 9 there are still a lot

14 of questions, a lot of gray areas in this

15 regard among certifiers. So we're asking that

16 the recommendations to the NOP to develop

17 sound guidance, again, sound methodology on

18 determining organic content, calculation of

19 organic ingredients, and as well as developing

20 training for certifiers to make sure that

21 we're all on the same page to answer some of

22 those gray area questions. 
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1 Biological diversity. Again, we

2 participated with the ACA to develop comments. 

3 We're in support of biological diversity

4 conservation and practice on farm as well as

5 extending to handlers or all certified

6 operations. We're supporting the need for

7 clearer instruction, training for certifiers

8 as well as for clients out there and having a

9 measurable standard. Thank you.

10 CHAIRPERSON FLAMM: Thank you,

11 Jessica. Does any board member have a

12 question for Jessica? Yes, John.

13 MR. FOSTER: What were you going

14 to say about measurable? I like things that

15 are measurable. Is that what you were about

16 to finish saying there?

17 MS. WALDEN: With regard to

18 biological diversity. Just having some sort

19 of measurable standard so that we can -- for

20 enforcement purposes.

21 MR. FOSTER: Okay, thanks.

22 CHAIRPERSON FLAMM: Any other
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1 question for Jessica? Thank you very much,

2 Jessica.

3 MS. WALDEN: Thank you.

4 CHAIRPERSON FLAMM: I guess we --

5 we've had a couple of cancellations. Unless,

6 Michelle, is there anyone else for the

7 morning? Appreciate the discussion, comments,

8 this morning. We'll now break for lunch and

9 be back here at 1 o'clock. Thank you.

10 (Whereupon, the foregoing matter

11 went off the record at 11:33 a.m. and went

12 back on the record at 1:06 p.m.)

13 CHAIRPERSON FLAMM: We'll continue

14 the public comments now. Pat Kane will be our

15 first commenter. Pat?

16 MS. KANE: I would like to thank

17 the board for the opportunity to provide these

18 comments. I am Patricia Kane, coordinator of

19 the Accredited Certifiers Association. ACA

20 did submit written comments on the following

21 discussion documents, "Implementation of

22 Biodiversity Conservation in Organic
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1 Agriculture Systems," "Calculating Percentages

2 in Organic Multi-Ingredient Products," "Other

3 Ingredients" and "GMO and Seed Purity."

4 I would like to summarize our

5 comments here but also urge you to review our

6 written comments as we included many specific

7 suggestions pertaining to these documents.

8 Regarding the implementation of

9 biodiversity conservation the ACA supports the

10 continued work on the implementation of

11 biodiversity conservation practices. We

12 believe that the primary reason for

13 inconsistent implementation of this is a lack

14 of guidance from the NOP. The development of

15 clear, concise educational information for

16 producers and ACAs is another key to moving

17 the biodiversity conservation forward. 

18 Based upon our members'

19 experiences we believe that producers do not

20 have enough information regarding biodiversity

21 conservation to assess the necessity and

22 importance of this.
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1 An additional impediment to

2 implementation of biodiversity conservation is

3 that there is a lack of specificity in the

4 rule regarding biodiversity conservation. 

5 ACAs have difficulty determining the

6 enforcement provisions for biodiversity

7 conservation due to this lack of specificity. 

8 The inclusion of requirements to

9 address conversion of high-conservation land

10 is also problematic in that there is no

11 reference in 7 C.F.R. 205 to conversion of

12 high-conservation land. Therefore, ACAs could

13 not enforce the requirements for this issue. 

14 We encourage the board to request clear and

15 comprehensive guidance regarding biodiversity

16 conservation be published by the NOP.

17 Calculating percentages in organic

18 multi-ingredient products. ACA believes that

19 certifiers perform calculations of organic

20 ingredients in a consistent manner and that

21 standardized forms are not necessary to

22 accomplish this work.
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1 We do believe, however, that

2 clear, comprehensive guidance from NOP would

3 ensure additional consistency in this task. 

4 We encourage the board to move forward with a

5 detailed recommendation to the NOP regarding

6 the need for a clear and comprehensive

7 guidance document regarding calculation of

8 organic percentage in multi-ingredient

9 products.

10 Additional webinar-style training

11 for ACAs by the NOP should also be encouraged. 

12 Our written comments provided suggestions

13 regarding information to be included in

14 guidance on this topic. 

15 Other ingredients. The ACA

16 supports baseline criteria established in the

17 other ingredients discussion document and the

18 continued development and refinement of option

19 B. 

20 We also believe that the success

21 of any of the options put forth is based upon

22 final guidance on the definitions of
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1 synthetic/non-synthetic. We urge completion

2 of the work on classification of materials and

3 supporting guidance documents.

4 GMOs and seed purity. Our members

5 believe that the issue of contamination from

6 genetically modified crops is a larger issue

7 than just contamination of only organic crops. 

8 Many producers of value-added identity9 preserved conventional crops are also affected

10 by this issue. 

11 While to date the genetically

12 modified crop production industry has resisted

13 both the labeling of GMO products and

14 addressing the issue of contamination from

15 these crops we believe that ultimately the

16 entire agricultural industry must work towards

17 eliminating the genetic contamination issue.

18 The responsibility for prevention

19 of contamination of organic crops must not

20 rest solely with the organic producer. A

21 defined seed purity protocol would be welcome

22 providing that this protocol is primarily
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1 focused on a process-based system to include

2 increased education and guidance for producers

3 and certification agency staff with genetic

4 contamination testing used as a last resort. 

5 Thank you for your work and the

6 opportunity to provide feedback.

7 CHAIRPERSON FLAMM: Thank you,

8 Pat. Does any board member have questions for

9 Pat? Thank you very much. Next commenter? 

10 And please give your name, Kevin, and your

11 affiliation. And you can take a moment for

12 your past in case people don't know your

13 affiliation.

14 MR. ENGELBERT: Okay. Hello,

15 everyone. I'm Kevin Engelbert, organic dairy

16 farmer, beef farmer and crop farmer, past NOSB

17 member, class of January 2011 with my last

18 meeting in the fall of 2010. 

19 I threw these thoughts together as

20 I sat here this morning. I wasn't originally

21 going to comment so please bear with me. They

22 might not be as organized as I would like them
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1 to be.

2 Thank you all for listening to my

3 thoughts. As a past board member I certainly

4 appreciate the task you're faced with, and

5 although I miss being on the board I must

6 admit that I do somewhat enjoy being back on

7 this side of those tables even though I'm no

8 longer one of the decision-makers and I only

9 have a few minutes to express my thoughts. 

10 When I was a member I always

11 thought that the work of the NOSB would have

12 been much easier and gone much smoother if I

13 had simply been allowed to make all the

14 decisions because I'm very set in my beliefs

15 and opinions. Anyone I served with while on

16 the board will attest to that. 

17 At any rate, I'll try to be brief

18 in my comments out of compassion for what I

19 know lies ahead of you in the next few days. 

20 Due to a weather disaster that took place on

21 my family farm just over a year ago I've been

22 unable to follow the work of the NOSB for
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1 nearly 15 months. Therefore, I'm not going to

2 give specific thoughts with regards to your

3 recommendations for this meeting. I will,

4 however, make a few general comments.

5 First, I must express my dismay

6 over some of the votes that have taken place

7 since I've been off the board. I cannot

8 understand why many of the substances that

9 came before the board were approved. 

10 The goal should be to have organic

11 represent the most pure food possible, not the

12 most complete food available. After

13 consulting with their pediatrician or doctor

14 people should buy supplements if necessary to

15 meet specific dietary requirements. But your

16 objective must be to ensure organic food

17 reaches the store shelves with an absolute

18 minimum amount of processing and added

19 substances. 

20 Consumers should come to expect

21 that organic foods will vary in texture, color

22 and even taste depending on the time of year,
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1 where the crop was grown, the crop variety, et

2 cetera. Trying to ensure that every package

3 of any given product is identical no matter

4 where or when it's produced or purchased is

5 not compatible with organic agriculture. The

6 same holds true for the attempts to make

7 certain organic foods supply complete

8 nutrition that they do not naturally possess. 

9 In the same manner as farmers when

10 they're growing organic food, processing and

11 marketing companies cannot expect to use the

12 same inputs when handling organic foods that

13 they do with conventional foods. Not only

14 should organic food start out pure on the

15 farm, it must remain so throughout the entire

16 manufacturing, packaging and/or handling

17 process.

18 Also remember that 100 years ago

19 or in some cases even more recently all food

20 was organic and that's the ideal the organic

21 label should represent today. In my opinion

22 that approach does not mean taking a step
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1 backward with our food supply but actually a

2 step forward after decades of taking steps

3 backward. 

4 Right or wrong, when I served on

5 the NOSB I was careful to weigh the

6 information that was presented based on one

7 major criteria first, namely, does the person

8 or entity providing the info have a financial

9 stake in the board's final decision. 

10 Your role as the current foster

11 parents of organic agriculture has certainly

12 become more difficult as the program enters

13 its teenage years. In your deliberations

14 always remember that necessity is the mother

15 of invention. Protecting the organic label

16 from those who try to weaken the rule is

17 indeed a difficult process and I wish you

18 success in doing so.

19 Next, I've not had time to talk

20 with current board members to find out the

21 reasoning behind the change in order from --

22 I've got a long way to go. I thought I was
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1 keeping this short but apparently I'm reading

2 very slowly. 

3 CHAIRPERSON FLAMM: Since I asked

4 you to state a little of your background I'll

5 give you 30 seconds more.

6 MR. ENGELBERT: Okay. Let's see,

7 where did I pick up. I'm not in favor of

8 voting on any recommendation the same day that

9 it's presented. Even topics the board has

10 consensus on should not have a final decision

11 made until the last day of the meeting so that

12 there's time for additional thoughts or

13 information to surface.

14 I also believe that any committee

15 recommendation that differs from one posted on

16 the meeting agenda should have its vote

17 postponed until the following meeting to

18 ensure that community has an adequate time to

19 express their opinion. 

20 Also, public comments should be

21 allowed for 5 minutes with unlimited time for

22 questions from the board. Anyone who wishes
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1 to present oral comments must be allowed to do

2 so. Long days are not a viable reason to

3 limit public comments. 

4 My first NOSB meeting had one day

5 that lasted over 13 hours but there were no

6 complaints from board members. We knew what

7 we were getting into. To truly fulfill the

8 intent of OFPA and the role of the NOSB public

9 participation cannot be restricted.

10 My last comments are for the NOP

11 but Miles has already heard all of them so I

12 will thank you once again for your dedication

13 and for listening to my comments.

14 CHAIRPERSON FLAMM: Thank you very

15 much, Kevin, and it's great to see you again. 

16 Any board member have a comment, question for

17 Kevin? 

18 MR. ENGELBERT: Thanks again.

19 CHAIRPERSON FLAMM: Thank you,

20 Kevin. Next commenter please state your name

21 and your affiliation.

22 MR. NORMAN: Hello, my name is
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1 Drew Norman. My wife and I run One Straw Farm

2 and I'd like to thank you all for hearing my

3 comments today. Unfortunately the second half

4 of my comments were lost in cyberspace so I'm

5 going to have to wing the second half of it.

6 One Straw Farm has been operated

7 since 1983. We've always operated using

8 organic methods. Our goal has always been to

9 farm in an environmentally sound manner. We

10 first achieved organic certification in 1986

11 through the OCIA and have remained certified

12 through the 2011 season.

13 In 2011 One Straw Farm received

14 Rodale's Pioneer of Organics Award. We

15 currently farm 175 acres of hay and

16 vegetables, employing 25 people and three

17 generations of our family. Most of our

18 produce is marketed through an 1,800-person

19 CSA.

20 One Straw Farm has always used

21 agricultural films and drop irrigation for

22 their production benefits, higher yield, weed
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1 control, and most importantly water

2 conservation, a savings of up to 60 percent

3 over conventional irrigation methods. 

4 The downside of polyethylene mulch

5 is the cost of removal and disposal at the end

6 of the season. PE or polyethylene mulch is

7 too dirty to be recycled and therefore has to

8 be landfilled. I've always felt that PE mulch

9 compromises the integrity of the produce

10 raised on One Straw Farm. 

11 Imagine my delight when I first

12 became aware of BioTelo, a cornstarch-based

13 biodegradable mulch film. This film offers

14 all the benefits of polyethylene films without

15 the downsides.

16 Our decision to use BioTelo was

17 not made lightly but was made openly. We were

18 up front with our certifying agency from the

19 very first roll that was used. We made this

20 decision because we felt it was the more

21 environmentally friendly way to farm. 

22 We also assumed that we were not
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1 in violation of our certification because the

2 law states that biodegradable mulches were

3 allowed. We also hope that because of the

4 reciprocity agreement between Canada and now

5 Europe that BioTelo would be allowed by the

6 NOP.

7 In February 2012 we were asked to

8 stop using BioTelo or have our certification

9 revoked. We chose to continue to use BioTelo

10 and withdraw our certification. This decision

11 was heart-wrenching because 20 percent of our

12 sales at the time were through organic

13 wholesale markets which we could no longer

14 supply without certification.

15 In 2009 I tried my first roll of

16 BioTelo with very positive results. The mulch

17 performed as needed and provided early season

18 moisture and weed control. This is where I

19 have to start ad-libbing. At the end of the

20 season we ran a ditch through our field and

21 planted our cover crop which was probably in

22 late October. By the following spring there
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1 was no evidence of the mulch in the field.

2 When used in early spring for

3 early season crops and when the soil is very

4 active, biologically active, I find that the

5 mulch disappears within 6 weeks, as early as

6 6 weeks, maybe 2 months. So -- with virtually

7 no residue in the field. Several years ago I

8 had a field in hay that had been there for

9 about 5 years and when I worked the ground up

10 I found polyethylene mulch in that field which

11 had been in there -- had not been used in that

12 field for at least 5 years. 

13 So regardless of how well you

14 remove polyethylene mulch from the field you

15 still find pieces of it. It's impossible to

16 completely remove it all. In a field with --

17 thank you. Any questions?

18 CHAIRPERSON FLAMM: Thank you,

19 Drew, for your comments. Any questions from

20 the board? Jay, go ahead.

21 MR. FELDMAN: Thank you, and

22 thanks for making your farm available for
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1 field visits on this. Have you taken a look

2 at the annotation that the subcommittee came

3 up with, the Crops Subcommittee?

4 MR. NORMAN: Briefly.

5 MR. FELDMAN: I'm wondering about

6 the level of specificity that we put -- that

7 the NOSB puts on an annotation regarding the

8 practices that farmers utilize when using this

9 material. And to what -- where did you get

10 your instruction from and to what extent have

11 you followed the manufacturer's instructions

12 or innovated to ensure that you're seeing the

13 degradation in the time frame you're talking

14 about?

15 MR. NORMAN: We first started

16 using -- the first year we used it we used one

17 roll. And it just became very obvious that it

18 performed the way it was supposed to and that

19 it broke down very quickly at the end of the

20 season. 

21 You know, I can see that there

22 would be situations where the mulch might not
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1 work, or might not break down properly or

2 quickly, but I would think that a farmer who

3 was in a situation like in a very dry area

4 where if he stopped irrigating the soil

5 biology would stop and then the mulch would

6 stop breaking down. If it didn't work for him

7 he probably wouldn't use it. 

8 I mean, it's very expensive so a

9 farmer's not going to choose to use this if it

10 doesn't really work for him. We sort of feel

11 that it's cost-effective for us because we

12 don't have the disposal, the removal and

13 disposal costs. But it costs two and a half

14 times as much as polyethylene mulch does. So

15 it's not a decision that's made lightly.

16 CHAIRPERSON FLAMM: Jay, go ahead

17 with your follow-up question.

18 MR. FELDMAN: Quick follow-up. 

19 Some of the studies we're looking at, the

20 protocol for the studies involve plowing in or

21 disking in the material at the end of the

22 season. Is that the practice you utilize?
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1 MR. NORMAN: That's the practice I

2 use. I mean I -- one of the advantages that

3 I find in using the biodegradable mulch, it

4 allows me to get my cover crops in quicker at

5 the end of the season. So you know, if we

6 have a wet fall I don't have to go through all

7 the time to remove a polyethylene mulch. I

8 can just quickly run a disk through the field

9 and plant my cover crop. So it's time-saving

10 for me as a farmer to be able to use this

11 mulch.

12 CHAIRPERSON FLAMM: Zea has a

13 comment for you, Drew. Or question, excuse

14 me.

15 MS. SONNABEND: Thank you, Drew. 

16 Some of the commenters who have concerns about

17 the mulch have questioned whether it would

18 leave behind residues. Not that you can see,

19 but residues of some of the chemicals used as

20 pigments or plasticizing agents or things like

21 that. And I'm wondering if you thought about

22 that at all in your decision to use it and
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1 what satisfied you that it wouldn't leave

2 chemical residues behind.

3 MR. NORMAN: Oh, well that's a

4 pretty tough question because you're talking

5 to a farmer and not a scientist. 

6 MS. SONNABEND: But you made the

7 decision so I'm just interested in how you

8 made the decision.

9 MR. NORMAN: We made the decision

10 based on the fact that it had been certified

11 as being 100 percent biodegradable which is

12 something we read on the internet. So, you

13 know, we didn't enter into this lightly. We

14 did as much research as we could before we

15 decided to use it wholeheartedly and farm16 wide. So based on the information that I as

17 a farmer could find I felt like I was

18 comfortable using it.

19 MR. FOSTER: Yes, Drew, two-part

20 question. One is how long is your growing

21 season and what's your annual rainfall -- or

22 amount of precipitation?
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1 MR. NORMAN: Our dormant season

2 starts in November and depending on the

3 weather goes into March. So what's that, 5

4 months? And our rainfall is 40-45 inches a

5 year. I live in central Maryland.

6 CHAIRPERSON FLAMM: Carmela has a

7 question for you.

8 MS. BECK: I was wondering, there

9 was public comment that said that the plastic

10 mulch shouldn't be used 2 years in a row

11 consecutively in the same field. Do you have

12 any thought on that or what your practices are

13 or why that would not be?

14 MR. NORMAN: I mean, the integrity

15 of the mulch is there in 2 years. The problem

16 that we've run into is the weed control

17 necessary to keep the weeds out for that long

18 of a period of time. You know, we get a lot

19 of winter annuals growing in our area and our

20 ground would be frozen so it would be very

21 difficult to control weeds over the course of

22 winter. And quite frankly I wouldn't want to
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1 leave my ground open to erosion in order to

2 use the mulch 2 years in a row.

3 CHAIRPERSON FLAMM: Any other

4 board questions for Drew? Go ahead.

5 MR. MARAVELL: Drew, on the last

6 question I think the issue was would you

7 voluntarily want to skip every other year

8 rather than try to utilize it for 2 years in

9 a row. I think in your conditions there

10 wouldn't be anything the second year to

11 utilize. But would you have any reason to

12 want to as a policy for your operation skip

13 and never use it 2 years consecutively?

14 MR. NORMAN: Quite frankly I don't

15 see the point. It's not used on every field

16 every year anyway because part of our farm is

17 in hay, part of our farm is in direct-seeded

18 crops. So you know, out of the 50 acres of

19 produce that we grow half of that is in

20 direct-seeded crops where no mulch is used

21 anyway. And then you know, a large portion of

22 our farm is in hay at any given time. So,
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1 conceivably it's only used on a given field

2 probably every third year just because of crop

3 rotation and what have you.

4 CHAIRPERSON FLAMM: Thank you very

5 much, Drew.

6 MR. NORMAN: Thank you.

7 CHAIRPERSON FLAMM: Next

8 commenter. Please give your name and

9 affiliation.

10 MS. NORMAN: My name is Joan

11 Norman. I am the other half of One Straw

12 Farm. You just heard my husband speak. We've

13 been farming obviously for a long time. I

14 always say we started farming back when the

15 dinosaurs roamed the Earth and organic farming

16 was not something you could Google on the

17 internet.

18 We originally started farming and

19 were selling organic produce but really didn't

20 know what it was. I had a farm who rented a

21 truck to organic farms and that's how we found

22 out about a certifying agency and we became
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1 certified in 1986.

2 I am the other half of One Straw

3 Farm so when he wanted to use this

4 biodegradable mulch I was the one in charge of

5 looking up the research. Part of the reason

6 we said it was -- we decided it was okay and

7 was following organic standards was it was

8 certified biodegradable by a third party

9 agency, so it wasn't just the company saying

10 it. 

11 And the second part of it was it

12 was made from a non -- it was not GMO corn, it

13 was GMO-free corn. You know, we could get

14 corn stalks from our next door neighbor and

15 put them down as mulch and that would be

16 allowed under organic certification law which

17 we wouldn't do. This was non-GMO and it was

18 breaking down so we saw no reason that we

19 could not use it.

20 On our farm we have a large CSA. 

21 We roughly feed about 10,000 people a week

22 from our farm. And we polled most of them and
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1 asked them their opinion on this. And all of

2 them said if we were not using BioTelo that we

3 would be environmentally irresponsible and

4 they would not want to get food from us. So

5 all of them have supported our decision. The

6 only person who cannot buy from us is our

7 organic wholesale and we gave up $100,000 this

8 year to not sell organic produce. 

9 But we felt it was important to

10 push forward. As Drew said we got the Pioneer

11 of Organic Award. Sometimes you just have to

12 go first. We were first 29 years ago when

13 nobody else was growing organically, at least

14 in our neighborhood, and they thought we were

15 growing marijuana though I had to remind them

16 that frankly if I was selling marijuana I

17 would have made a lot more money.

18 So this is not an easy decision

19 for us. We're not walking away from organic. 

20 I feel like I'm having a partial divorce and

21 all I really want to do is get it back. It's

22 really hard to say that we're One Straw Farm,
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1 the largest used to be organic vegetable farm

2 in Maryland and now I have this empty hole.

3 So we look forward to this being

4 approved. Organic farmers need it. It's

5 allowed in Canada. That was the other reason,

6 it's allowed in Canada. They can grow organic

7 produce and sell it in my country as organic

8 but I can't do the same thing. 

9 The day after I mailed in my

10 certification they announced a reciprocal

11 agreement with Europe. It makes me furious. 

12 Why can other countries sell organic produce

13 in my country and I can't do the same thing? 

14 It's just not right. If it was that wrong

15 everywhere else in the world why do we allow

16 it into our country? If you didn't allow it

17 from other places I might feel differently,

18 but I don't. 

19 So there has been research done in

20 other places. They're allowing it in Canada,

21 they allow it in Europe and it should be

22 allowed for organic production here.
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1 My customers and ourselves

2 respectfully request that you vote in favor

3 for it. Can I answer any questions from

4 anyone? I even still have a green light. I

5 guess I'm done. Thank you very much. 

6 CHAIRPERSON FLAMM: Will the next

7 commenter please come to the podium and give

8 your name and affiliation? 

9 MS. BADEN-MAYER: Hello, I'm

10 Alexis Baden-Mayer. I'm the political

11 director of the Organic Consumers Association. 

12 We have 385,000 members and 9,000 of them

13 submitted comments in opposition to adding new

14 synthetics to organic at this meeting. 

15 Organic consumers oppose adding L16 methionine for use in infant formula made with

17 isolated soy-based protein. The main basis

18 for the Handling Subcommittee's recommendation

19 that L-methionine be allowed is that it is

20 essential for organic soy-based infant

21 formula. 

22 Organic consumers disagree with
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1 this notion of what's essential. We deserve

2 the right to know when the use of an

3 ingredient in organic infant formula is going

4 to require adding a synthetic. 

5 Companies that manufacture infant

6 formula are notorious for hiding from us the

7 fact that infant formula provides inadequate

8 nutrition when compared with breast milk. 

9 Infant formula companies depend on us being

10 ignorant of the fact that babies shouldn't

11 consume anything but breast milk for the first

12 9 months and that babies should be breast fed

13 for at least 2 full years.

14 The National Organic Program

15 becomes part of this problem just by allowing

16 infant formula to be marketed as organic. But

17 if you wanted to convince consumers that

18 organic food is the most natural store-bought

19 food available allowing synthetics in organic

20 infant formula completely destroys the idea

21 that the organic version is the most natural.

22 Of course, most parents aren't
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1 going to know. They'll think that the infant

2 formula made with isolated soy-based protein

3 is just as organic as the infant formula that

4 doesn't contain synthetics. That would be a

5 fraud on parents considering buying organic

6 infant formula. This fraud should be stopped. 

7 If this fraud continues we're

8 going to need new labels, USDA organic, made

9 with synthetic L-methionine, made with organic

10 ingredients and synthetic L-methionine. Then

11 parents could find out what L-methionine is

12 and when we looked into it we would learn that

13 it isn't an organic ingredient. We would

14 learn that while L-methionine could

15 potentially be developed from naturally

16 obtained sources the organic regulators chose

17 to allow the kind that comes from a source

18 that uses cyanide. 

19 We would learn that the over20 supplementation of L-methionine has been shown

21 to have detrimental effects on the uptake of

22 other critical amino acids as well as causing
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1 fatty deposits in the liver. Anyone who

2 learned these things about L-methionine would

3 wonder how in the world it ended up in organic

4 infant formula. It's not even allowed for

5 other organic foods. 

6 How about not approving L7 methionine? Then you could be straight with

8 parents considering infant formula. You could

9 tell us the truth. Yes, there is infant

10 formula that contains organic soy, but that

11 formula isn't labeled organic because it

12 requires the addition of a synthetic that

13 isn't compatible with organic. Then parents

14 could make informed choices. 

15 Please, when you are making

16 decisions about whether or not to allow foods

17 that contain synthetic ingredients to be

18 marketed as organic, please keep in mind that

19 consumers deserve the right to know. There

20 shouldn't be synthetics hiding in our organic

21 food. The organic seal shouldn't conceal.

22 CHAIRPERSON FLAMM: Thank you,
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1 Alexis. Do board members have questions for

2 Alexis? Jay?

3 MR. FELDMAN: Thanks, Alexis. So

4 here's the dilemma as I understand it. If you

5 use soy you have to use methionine. So the

6 effect of not approving methionine would be to

7 disallow soy-based formula as being labeled

8 organic. Is that your understanding?

9 MS. BADEN-MAYER: Well, it's not

10 that it would be taken off of the market. It

11 would be there. You could have a formula that

12 was made with organic soy, but if it contained

13 this synthetic that we don't consider

14 compatible with organic it couldn't have a

15 front label claim that said organic. It

16 couldn't have a USDA seal on it and it

17 couldn't be marketed as made with organic. So

18 it couldn't be certified organic and marketed

19 to consumers that way. 

20 But consumers who for some reason

21 are looking for a soy-based formula and would

22 prefer one that had organic soy in addition to
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1 the synthetics that are necessary for this

2 type of formula, they could still seek that

3 out. But it wouldn't be marketed by the

4 organic program as organic. 

5 MR. FELDMAN: Right, but the

6 problem is that, you know, if you talk to the

7 American Academy of Pediatrics and others the

8 fact that the soy does not have methionine

9 which is part of the nutritional balance

10 needed in the product, it would not be

11 marketable at that point. Which I'm not

12 suggesting is not an endpoint that the board

13 wouldn't want to embrace. I mean, that might

14 be the endpoint that the board wants to

15 embrace. But I'm just saying that the effect

16 of that decision by the board would limit the

17 marketability in the organic sector.

18 And that raises questions such as

19 so what. And that's why I'm glad that the AAP

20 folks are coming, we can address the question

21 with them as well. What would happen to the

22 organic consumer if soy, organic certified
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1 soy-based formula were not available. 

2 MS. BADEN-MAYER: I believe it

3 would be available, it just wouldn't be

4 marketed as organic. 

5 MR. FELDMAN: Okay, thank you.

6 CHAIRPERSON FLAMM: Any other

7 questions for Alexis? Yes, Tracy.

8 MS. FAVRE: So, how would you feel

9 about a made with label with synthetic L10 methionine?

11 MS. BADEN-MAYER: Well, that's --

12 when I go shopping and I see made-with

13 products I know that those products also

14 cannot have unapproved synthetics in them. 

15 And most consumers probably just believe they

16 don't have synthetics in them. And so I think

17 that we're mis-marketing these products if we

18 load them up with synthetics and label them

19 exactly the same as organic products that

20 don't have synthetics. 

21 Now, we are going to have, you

22 know, if this L-methionine were approved we'll
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1 have some organic infant formulas that don't

2 contain synthetics and some organic infant

3 formulas that do contain synthetics, but that

4 won't be apparent to the consumer. Nobody --

5 the consumers aren't sitting here with us

6 seeing how these decisions are made and

7 there's no information on the label other

8 than, you know, you could turn the product

9 around and see L-methionine but you would just

10 assume that was organic probably. And if you

11 didn't assume that it was organic at least you

12 would think it was non-synthetic, you would

13 think it was natural, because after all it's

14 allowed in organic. 

15 And so we don't have a way right

16 now if informing the consumer about added

17 synthetics in organic. And I think that's a

18 big problem, especially since every single

19 meeting every 6 months we're adding new

20 synthetics to organic.

21 CHAIRPERSON FLAMM: Do you have a

22 follow-up question, Tracy? Go ahead.
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1 MS. FAVRE: So, do I understand

2 from that comment that the difference between

3 the organic and the made with organic label is

4 not clear to consumers and you aren't

5 supportive of the made-with?

6 MS. BADEN-MAYER: I certainly -- I

7 buy made-with products and I know that the

8 made-with products have essentially the same

9 rule for the 30 percent as the USDA organic

10 products have for the 5 percent. So, and I

11 think that's a good thing, and I think that

12 that encourages consumers to buy made-with

13 products when USDA organic products are not

14 available. So no, certainly I don't want to

15 dismiss the value of the made-with label. But

16 I don't think it would be appropriate to add

17 synthetics to made-with products either

18 because consumers assume that those products

19 as well do not contain synthetics.

20 CHAIRPERSON FLAMM: Any additional

21 questions from the board? Thank you very

22 much, Alexis.
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1 MS. BADEN-MAYER: Thank you.

2 CHAIRPERSON FLAMM: Next

3 commenter, please? Please give your name and

4 affiliation.

5 MR. LAROSE: Good afternoon, my

6 name is Rob LaRose. I'm the president of

7 BioSafe Systems. And I first attended this

8 meeting back in Savannah and I was a

9 petitioner for ammonium nonanoate herbicidal

10 soap. 

11 And I just, I guess my role here

12 today is to just kind of report back to you

13 all as, you know, even though we were not

14 successful yet in our petition we did

15 successfully launch our product AXXE to the

16 parts of the market which is turf and

17 ornamental in landscapes where it is allowed

18 to be approved as organic use and it's been

19 very well received. 

20 I must say that pretty much what

21 we thought was going to be the case is that

22 many of our customers are also organic growers
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1 and they were wondering how come we're selling

2 this product and they can't use it. And we

3 tried to explain to them, well, this is what

4 happened at the meeting, this is what has been

5 said and this is where you folks are at. 

6 And the amount of calls that we've

7 taken and the confusion that our people are

8 dealing with out in the field where they're

9 seeing something that's listed, NOP-listed,

10 it's allowed for certain uses on ornamental

11 landscaping and greenhouse growing but they

12 can't use it in any type of agriculture other

13 than maintenance of fencing lines and things

14 like that.

15 The interesting development is

16 that many of our sales lately have been to

17 conventional growers who see the benefits in

18 it and have bought into the program by a large

19 degree. So I guess I'm here to ask the board

20 to reconsider your position on this because I

21 think you're going to be hearing more and more

22 about it in the future. And there's really,
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1 you know, there's nothing much our company can

2 do. 

3 We're a small company. We're --

4 somebody wrote an article about our

5 presentation last year in the New York Times

6 and painted us as this big business. We're a

7 $10 million company family business where my

8 three kids work in my business taking

9 advantage of their college education and

10 trying to get that back. And my wife's here

11 with me today. 

12 So we've been serving the organic

13 industry since 1998. We have hundreds and

14 thousands of customers out there. So this is

15 a major issue.

16 One other one I want to point out

17 is that we're also involved in food safety and

18 I'm seeing a lot of issues being developed not

19 only having to address food safety in a

20 packing house or processing plant but also in

21 the field. And I don't believe right now

22 there's enough guidance to address how to --
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1 for the organic growers, how to address food

2 safety issues in the field either treating

3 irrigation waters or treating the crops in the

4 field. And it seems to be progressing a lot

5 faster on the conventional side than on the

6 organic side. There seems to be -- the

7 awareness is just not there. And I think that

8 the board should take a serious look at that

9 and maybe create a position for itself there

10 because there's a lot of issues out there that

11 need to be addressed and this is a big hole

12 from what I can see.

13 CHAIRPERSON FLAMM: Thank you,

14 Rob.

15 MR. LAROSE: I want to say thank

16 you.

17 CHAIRPERSON FLAMM: Does any board

18 member have a question for Rob? Harold, go

19 ahead.

20 MR. AUSTIN: Rob, when your

21 product was approved for use as a herbicide or

22 a weed killer for ornamental and fence line,
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1 what was the rationale given for its not being

2 allowed for agricultural use in tree crops or

3 whatever other crops you're trying to utilize

4 it in?

5 MR. LAROSE: I mean, what I heard

6 was that it met all the tenets of being an

7 organic product allowed for use in organic

8 production but really it came down to the

9 terminology I think is that we were calling it

10 an herbicide, it's an effective herbicide but

11 there's no place in organic farming for an

12 effective, low-cost herbicide. What I heard

13 was it makes it too easy, or it shouldn't be

14 that easy to be an organic grower. And when

15 I tell that to folks out there in the field,

16 a hard-working farmer, they're just

17 flabbergasted by that position. And so

18 there's just a lot of confusion. And they

19 take it out on us.

20 CHAIRPERSON FLAMM: Harold, do you

21 have a follow-up question?

22 MR. AUSTIN: Your comment on the
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1 food safety issues. Could you clarify your

2 thought process behind that?

3 MR. LAROSE: Well, as we're going

4 along we focus primarily on high-value crops. 

5 And what we're finding is there's a lot of

6 mitigation issues that have to happen out in

7 the field. In some cases with blueberries and

8 strawberries and raspberries we're doing pre9 harvest sprays out in the field as a

10 mitigation step for contamination. And you

11 know, it's -- there just doesn't seem to be a

12 place just yet to allow that in organic

13 production.

14 Also, there's a lot of -- there's

15 just confusion as to where, how you should

16 treat irrigation water, should we do these

17 pre-harvest sprays, is that part of, you know,

18 what types of products are we going to use for

19 that. So there's, you know, there's just

20 another level of mystery. And it's shared on

21 the conventional side too. We're working --

22 they seem to be working through it faster.
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1 CHAIRPERSON FLAMM: Thank you. Is

2 there any other questions from the board? 

3 Thank you very much for your comments.

4 MR. LAROSE: You're welcome.

5 CHAIRPERSON FLAMM: Michelle, is

6 there any other public comment? That

7 completes the general public comment session. 

8 We can now move to the Livestock Subcommittee

9 and I will turn the gavel over to Chairperson

10 Wendy. It's all yours.

11 MS. FULWIDER: Thank you, Barry. 

12 First, Lisa Brines would like to introduce the

13 petition for nonanoic acid.

14 MS. BRINES: Thank you, Wendy. 

15 Yes, the first petition on the agenda for the

16 Livestock Subcommittee is nonanoic acid. It

17 was petitioned April 29, 2011 by Stratacor

18 Incorporated. The petition requests the

19 inclusion of nonanoic acid at Section 205.603

20 of the National List as an insect repellant

21 for organic livestock. It's not listed

22 elsewhere currently on the National List. 
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1 Regarding the technical review of

2 this material there's two technical reports

3 available for this material. The first one

4 was developed in 2006 and that was in response

5 to the petition to allow this use in crop

6 production. It was petitioned under an

7 alternate name at that time which is

8 pelargonic acid.

9 In reviewing the petition the

10 Livestock Subcommittee did decide to request

11 a new updated technical report to address the

12 livestock issues. Both that technical report

13 and the petition were posted on the NOP

14 website in advance of the opening of the

15 public comment period for this material. And

16 I believe the petitioner is in the audience

17 and signed up for in-person public comment as

18 well. Thanks.

19 MS. FULWIDER: And Jean Richardson

20 will present on nonanoic acid.

21 MS. RICHARDSON: The material that

22 came before the subcommittee is nonanoic acid
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1 which is CAS-112050. And when we reviewed

2 this we determined that it was a synthetic. 

3 We then reviewed the listing motion to add

4 nonanoic acid 112050 to 205.603 insect

5 repellant. And the subcommittee determined

6 that they would not recommend this to be added

7 to the list.

8 Some comments from our work on

9 this. We found that it's a nine-carbon

10 straight chain fatty acid, occurs in low

11 levels in foods such as grapes, milk, oranges

12 and apples. We were concerned obviously to

13 find that it is also an EPA registered

14 fungicide and herbicide. It can be used as a

15 weed killer and a blossom thinner. Obviously

16 it wouldn't be used in such large quantities

17 being used as an insect repellant. On the

18 other hand, this certainly was of concern to

19 us.

20 We found in looking at the

21 petition, the TR, that it does not appear to

22 be a permitted substance on any of the lists
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1 in Canada, the European Union or Japan. We

2 were concerned reading the TR that it would

3 have a negative impact on a various range of

4 nematodes and other aspects of the soils and

5 would have potentially a negative impact on

6 the agro-ecosystem.

7 We also found in reviewing the

8 materials presented to us that there are

9 presently a wide range of effective

10 alternative treatments that are already

11 available in addition to the IPM and

12 management practices. And so for these

13 combination of reasons the committee voted not

14 to add this at this time. Thank you.

15 MS. FULWIDER: Any discussion from

16 the board members? John?

17 MR. FOSTER: So, when you said the

18 use of the material may -- I don't know

19 exactly what you said, but something to the

20 extent of may potentially have deleterious

21 effects on the soil ecosystems, something like

22 that. What do you mean by potentially? How
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1 is that quantified or measured or tested or

2 evaluated? I'm just wondering if you could

3 better define what "potential" stands for

4 there.

5 MS. RICHARDSON: If I look at the

6 TR line 333 the Davis in 1997 reported that

7 nonanoic acid is toxic to nematodes. And

8 while, you know, we don't necessarily -- some

9 nematodes are not good, but beneficial

10 nematodes or earthworms may also be impacted. 

11 There were the main aspects really that came

12 up that were of issue, in addition of course

13 to the potential impact as a weed killer and

14 a blossom.

15 I should also add that of course

16 there was public comment on this. And in

17 terms of the public comment there were two

18 universities and two corporations presented

19 supporting statements to consumers and one

20 non-profit environmental group opposed

21 addition. Those were the only comments that

22 we received to date.
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1 MS. FULWIDER: Go ahead, John.

2 MR. FOSTER: So, I guess I'm not -

3 - I'm not following. The nematodes and the

4 earthworms may be impacted? Potential to be

5 impacted? Like were there studies that showed

6 it killed beneficial nematodes, it killed

7 earthworms? That's kind of what I mean by is

8 that evidence or is that the potential that's

9 not known. So it's a -- maybe there could be

10 a problem and therefore we don't want to risk

11 it. Is that it?

12 MS. RICHARDSON: All I can --

13 well, I can probably look again in more detail

14 at it but my notes here simply say that it is

15 reported to be toxic to nematodes. It doesn't

16 say potentially toxic to nematodes, it says

17 nonanoic acid is toxic to nematodes.

18 MS. FULWIDER: Colehour?

19 MR. BONDERA: Yes, my memory and

20 understanding is exactly what you just said,

21 Jean, is that it is toxic to nematodes and

22 therefore like you were asking, John, that it
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1 may kill beneficial nematodes. You don't know

2 what nematodes it's going to kill because it

3 depends on what is impacted by its use. So,

4 therefore since it is toxic to nematodes it

5 could kill beneficial ones but depending on

6 the circumstance you don't know which

7 nematodes it will kill. That's my --

8 MS. FULWIDER: Any other

9 discussion? Okay, Lisa, if you would like to

10 introduce the petition for pet food amino

11 acids.

12 MS. BRINES: Thanks, Wendy. The

13 second petition before the Livestock

14 Subcommittee today is a petition for required

15 amino acids for pet food. This is a select

16 list of 13 amino acids which are specified in

17 the petition. 

18 The petition was submitted on

19 January 30, 2012 from the Pet Food Institute. 

20 And the petition is requesting amendment of

21 the National List to list these required amino

22 acids on Section 205.603 of the National List
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1 as an ingredient in organic pet food.

2 In support of its review the

3 Livestock Subcommittee reviewed the petition

4 and requested the development of a third party

5 technical report. That report was completed

6 and both the petition and technical report

7 were posted on the NOP website in advance of

8 the opening of the public comment period for

9 this meeting.

10 And just one follow-up to the

11 specific petition. There was an initial

12 petition that came from the Pet Food Institute

13 for taurine. That individual petition was

14 withdrawn and replaced with this more

15 comprehensive petition for more amino acids

16 all under the one petition for review by the

17 Livestock Subcommittee. 

18 And there is a representative from

19 the petitioner I believe in the audience who

20 is signed up for in-person public comment as

21 well. Thank you.

22 MS. FULWIDER: Thank you, Lisa. 
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1 Mac Stone will present the proposal on pet

2 food amino acids.

3 MR. STONE: Thanks, Wendy. Let me

4 preface the summary of this petition by saying

5 there was an e-glitch in posting our

6 recommendation and all of the background

7 wasn't posted for you all to witness. So

8 Robin, it will make a lot more sense when you

9 see the rest of it.

10 So at this time the subcommittee

11 is recommending that we not vote at this

12 meeting because you all are not privy to the

13 information that the subcommittee deliberated

14 on. And we'll make this decision at the

15 spring meeting in Portland.

16 So we would like to go through as

17 if we were voting, get as much feedback and

18 interest so that during the next semester we

19 can continue to get feedback and be sure that

20 we're making a sound decision on this

21 petition. 

22 So briefly, organic pet foods or
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1 mostly made with organic labels are allowed,

2 are being sold now. They're produced under

3 the livestock standards and labeled under the

4 handling standards. 

5 It's a very vibrant market. 

6 They're striving for continual improvement and

7 would like to have these amino acids available

8 so they can formulate diets with the various

9 ingredients that are available to them.

10 As Lisa said the Pet Food

11 Institute has petitioned for the 13 essential

12 amino acids as they are not grandfathered in

13 under the accessory nutrients as in the past.

14 In `05 there was a pet food task

15 force that was formed. They worked diligently

16 and this board in `08 proposed a

17 recommendation to the program which has -- the

18 program has in place and it is part of our

19 discussion document, our recommendation that

20 you can see when it's posted.

21 Pet foods are different than

22 livestock. Obviously dogs and cats, primarily
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1 what we're talking about, they are meat-eaters

2 and since they're not part of the food chain

3 it seems appropriate to allow them to use meat

4 and poultry products or byproducts in

5 formulating their diets.

6 These foods are regulated by AAFCO

7 which is actually an association of feed

8 control officials. Each state manages these

9 standards through their own regulatory

10 process.

11 So what it came down to is the

12 essentiality of the specific amino acids. 

13 Some of these can be synthesized by the

14 animals themselves from various proteins at

15 various levels. So which can be the

16 essentiality comes to, depending on how you

17 formulate the diet, which of these synthetic

18 amino acids might be added to call it a

19 complete and balanced ration if you will.

20 We didn't consider cost as a

21 factor. As any certified organic potato

22 farmer knows they're very expensive to get the
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1 seed potatoes and we don't use cost as a

2 factor.

3 There is seasonality and

4 geographic constraints to sourcing the

5 ingredients to have a complete and balanced

6 organic ration. So, with the interim rule on

7 vitamins and minerals that the program posted

8 it has given time for these materials to stay

9 on the market as we complete this aspect of it

10 without disrupting their commerce.

11 Through the public comment we did

12 receive comment back that formulators need

13 these specific amino acids depending on what

14 ingredients are available so that they can

15 call these complete and balanced diets. The

16 diversity of the dog world, very large dogs

17 may need different amounts of different amino

18 acids to balance versus very small dogs, so

19 it's a very diverse audience that they're

20 addressing.

21 We members of the subcommittee, we

22 looked at hundreds of pet food ingredient
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1 labels and there was not a consistent pattern

2 of need. These were not just organic labels,

3 these were commercial pet foods, high-end pet

4 foods, Ol' Roy and less involved pet foods. 

5 So we looked at the full gamut. 

6 And what became kind of apparent

7 to us is the only consistent that we could

8 find was taurine was being used in every

9 single cat food label that we found on the

10 market either organic or not. Taurine was in

11 some dog foods. DL-methionine, lysine were

12 also in a random array of dog foods but

13 there's no consistent pattern. Seemingly it

14 was kind of by manufacturers would tend to use

15 some and others wouldn't.

16 So, given that we do look forward

17 to public comment today. We do look forward

18 to continuing to work with -- listen to public

19 comment and take further input as we

20 deliberate on this through the next semester. 

21 Any questions for the board? 

22 MS. FULWIDER: Questions? No
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1 discussion? Then we will move onto the

2 omnivore discussion document and Tracy Favre

3 will present.

4 MS. FAVRE: Thanks, Wendy. Calvin

5 and I worked on the omnivore discussion

6 document obviously to address some of the

7 concerns and issues related to the L8 methionine step-down that's currently under

9 consideration and in the works for us.

10 The discussion document was really

11 to seek public input on some potentially

12 controversial ideas for how we might address

13 the lack of L-methionine -- or excuse me,

14 methionine in the diet. Next slide, please.

15 Basically the discussion document

16 was a list of -- a series of questions trying

17 to seek specific input, having some

18 conversation about the fact that pigs,

19 chickens and turkeys are omnivore but yet we

20 forced a vegetarian diet. 

21 The questions basically ask for

22 recommendations for 100 percent organic meat
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1 scraps or byproducts to be used in omnivore

2 diets, specifically poultry and pigs, since

3 it's natural for the omnivores to consume it

4 anyway. 

5 The feedback was sort of a mixed

6 bag but the majority of the respondents

7 responded no. And particularly it was in

8 regards to the perceived degradation of the

9 organic label should meat scraps or byproducts

10 be allowed back into organic. But there were

11 some pretty emphatic comments about the

12 positive benefits of organic meat scraps as

13 well.

14 The next question, question number

15 2 was about the herbal methionine and the

16 other sort of alternatives to meat scraps and

17 meat byproducts and how we should encourage

18 this type of research. Obviously that is less

19 controversial and received more overwhelmingly

20 positive support. 

21 Some of the comments were that

22 until synthetic methionine is disallowed there
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1 will be less incentive to further develop more

2 natural methods of L-methionine, and that it's

3 certainly worth exploring all potential

4 alternatives. 

5 There were some concerns raised

6 about the potential scalability of some of

7 these naturals, quote, "natural" methionines

8 and the ability to scale it up for larger9 scale production. And certainly, you know,

10 what do we have to do to bring these products

11 to commercial viability within the next 3

12 years. It was positively received but

13 obviously there's still some question as to

14 how to go about doing it.

15 One of the suggestions was to

16 conduct detailed studies in the U.S. Pretty

17 consistently we heard please don't eliminate

18 the synthetic methionine until we have a

19 viable alternative for that. 

20 And questions about how to spur

21 more production, manufacturing of natural

22 amino acids. Again, the comment about little
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1 incentive as long as synthetic is allowed, but

2 also recognition that there's been a fair

3 amount of work and conversation about this,

4 not only recently but there was a methionine

5 task force that looked at it as well.

6 And then if we are to allow

7 organic-approved meat and slaughter byproducts

8 what do we do to ensure that safeguards are in

9 place to -- for public health as well as the

10 perception of it. And there were some issues

11 raised in regards to the rendering facilities

12 and the ability to separate organic versus not

13 organic. 

14 And again, would the organic brand

15 be damaged. Pretty consistently we feel the

16 comments were that they felt the organic brand

17 would be damaged although some people came

18 with the comment that as long as the public

19 was properly educated it would be all right. 

20 There were some comments about a

21 concern on the use of fish meal due to

22 threatened populations and the threat of over-
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1 fishing. And would the rule change be

2 appropriate to help fulfill the essential

3 amino acids requirement, and if yes, state

4 what language would you use. And basically

5 the comments were very ambivalent about this. 

6 Again, it was reiterated that even an

7 annotation about this would not really provide

8 an effective solution. 

9 So, in the summary, you know,

10 there's strong broad-based support for

11 developing natural methionine. There's mixed

12 bag but a preponderance on negative response

13 to the introduction of meat byproducts and

14 meat scraps, and an emphasis on comments that

15 we need to enhance and further encourage the

16 development of natural methionine. 

17 Any questions? 

18 MS. FULWIDER: Mac?

19 MR. STONE: This document kind of

20 focused on meat and poultry products,

21 byproducts. The poultry industry, not just

22 organic but the outdoor poultry people are
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1 looking at insects as a protein source with

2 the high cost of feed grains and availability

3 of feed grains. So I'd just be curious if any

4 commenters are commenting on this. We'd like

5 to hear any interest, if there's any issue

6 with public perception of raising insects. Or

7 if you all discussed that that I missed.

8 MS. FAVRE: There were comments in

9 regards to the fact that they thought that was

10 a great idea. We didn't see specifically any

11 negative comments about the perception of, you

12 know, feeding grubs or maggots or whatever to

13 poultry.

14 Calvin coauthored this document

15 with me. Calvin, do you have any comments

16 that you want to add to that? 

17 MR. WALKER: I have none.

18 MS. FULWIDER: John?

19 MR. FOSTER: So, the insect thing

20 is really interesting to me. Some of us have

21 had conversations about that. But what came

22 up in conversation yesterday was really
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1 interesting to me and I don't necessarily --

2 I don't think we have the time to discuss it

3 here but I like -- I think it's appropriate

4 that we recognize some very large macro issues

5 when they come up that maybe we don't get

6 often enough the chance to talk about.

7 The one that really struck me

8 yesterday was with respect to how use of

9 synthetics might be beneficial to ecosystems

10 in a very indirect, convoluted way. 

11 With respect to, say, fish meal

12 being used as a protein source or a feed

13 source, well, if that does put undue pressure

14 on fish stocks then could that actually be, I

15 think the phrase we were using was a "deep

16 green" approach to actually tipping the scales

17 toward a few synthetics. And I'm not here to

18 make that proposal at the moment but I thought

19 that was a really good, large-scale, higher

20 than 30,000-foot view of the kind of issues

21 that we're probably going to need to contend

22 with more and more often. So I just encourage
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1 people to be thinking about maybe there's some

2 advantage. Not just to synthetics, I don't

3 mean to direct it there, but to other natural

4 sources of other materials, that's great. But

5 I love the idea of looking at preserving fish

6 stocks as a means of -- as a driver if you

7 will of a very sustainable approach to feed

8 stocks for livestock for which is going to be,

9 like that pressure is not going to go

10 anywhere. It's going to get worse, it's going

11 to get higher. People want their protein and

12 there's more people so we're going to need to

13 deal with that at some point. 

14 I really encourage us all to be

15 thinking about those indirect advantages that

16 may not be in our current discourse right now. 

17 So that was really helpful for me yesterday

18 and I hope we have ongoing conversations about

19 that.

20 MS. FULWIDER: Other discussion? 

21 Well, moving right along. Last but not least

22 we have a GMO Vaccine Working Group update. 
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1 And I will turn this over to Jean. 

2 MS. RICHARDSON: Thank you, Wendy. 

3 This is sort of just an update really from the

4 GMO Vaccine Working Group. The names of the

5 people that are on this are up there on this

6 slide. Where you have, it's a joint, this

7 USDA working group. 

8 We've got Melissa Bailey from the

9 NOP and she's sitting across the other side of

10 the table from me, Scott Updike who's not here

11 who has been active on this subject and

12 continues to be, and then we began to work

13 with some people at the -- at APHIS. Patricia

14 Foley has been on our conference calls and a

15 very helpful and active member. And we've got

16 Nick Maravell who is another member of the

17 NOSB board and he'll make some comments after

18 I've done sort of the general introduction

19 here.

20 And it's important to understand

21 that this is a presentation of the subgroup. 

22 It doesn't necessarily represent what our
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1 Livestock Subcommittee was working on earlier

2 but it is in fact a group report.

3 And just for some background for

4 especially if there's other people in the

5 audience and other committees that don't know

6 where all the pieces on vaccines in organic

7 livestock production are found in our -- in

8 Section 205. There are four different areas

9 of relevance when we're trying to understand

10 what it is that we're trying to resolve, the

11 problem that's before us. 

12 The first place is that in

13 238(a)(6) it states that the producer must

14 establish and maintain a preventive healthcare

15 practices including administration of vaccines

16 and other biologics. So there's the first

17 place.

18 And then in second place under the

19 National List of Allowed and Prohibited

20 Substances in terms of vaccines it simply

21 states at 603(a)(4) that biologics, vaccines

22 without any form of annotation. 
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1 The third place that vaccines are

2 found in 205 is to deal with emergency pest or

3 disease treatment, and also that includes

4 eradication programs. 

5 The important thing I think for us

6 to be clear about is that under 205.105(e) the

7 use of excluded methods which we commonly call

8 GM or GMO which we should really use the term

9 "excluded methods" this is prohibited in

10 organic production. And as we all know,

11 producers must provide written documentation

12 for seeds to show that they're not -- what

13 their seeds are, non-GMO. And for handlers

14 they have to show that if they have non15 organic ingredients they have to have written

16 documentation that they were not produced

17 using excluded methods.

18 There is an exception, however,

19 for vaccines provided that they are reviewed

20 and recommended for addition to the National

21 List by the NOSB in accordance with 205.600. 

22 So, all GMO are prohibited except for vaccines
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1 but it's an important note provided that

2 they're reviewed and recommended by NOSB. And

3 I repeat that because that obviously has not

4 yet taken place. 

5 So because of this inconsistency

6 within the rule in September of 2010 the NOP

7 requested the NOSB to review vaccines made

8 with excluded methods to be in accordance with

9 205.600. So, we on the Livestock Committee

10 proposed recommendations in a lengthy document

11 ready for the Albuquerque meeting. 

12 But public comment prior to the

13 meeting clearly demonstrated that there were

14 two sort of divergent positions on this. The

15 general public very loudly stated that they

16 wanted no GMO vaccines, but certifiers and

17 producers felt that they needed more detailed

18 information about current vaccine use and

19 production. So therefore this subcommittee

20 was established following the tabling of the

21 subcommittee recommendation.

22 But the NOSB passed a resolution
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1 requesting more information from the USDA and

2 we then set to work to try to unravel the

3 complexities of this. Initially we're trying

4 to determine which methods used to genetically

5 modify disease-causing agent could be

6 considered excluded and which could be

7 considered allowed. And there are a number of

8 nuances in there which we haven't really

9 sorted out at this point, but we're working on

10 it.

11 We also wanted to try to determine

12 if in fact we could find a list, could develop

13 a list. There is one presently published by

14 APHIS but would this list actually allow

15 organic producers, certifying agents and

16 veterinarians to determine if a vaccine was

17 made without the use of excluded methods. And

18 we did hear some public comment on that this

19 morning which I found very useful.

20 We also are trying to determine

21 what are the methods, can we verify the

22 methods by which the vaccines are being
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1 produced. Can we understand the current use

2 of those vaccines. And this is where the

3 public comment comes in in terms of the need

4 for knowledge collection. 

5 We need to know as much as

6 possible from the public those that are using

7 vaccines, whether they look to see if in fact

8 they are made with excluded methods or not. 

9 What is the current use, who's using them, are

10 they in combined vaccines, what does it look

11 like, to get as much of that information as

12 possible from Europe, from your perspective. 

13 Obviously we're still working with APHIS but

14 they may have a different perspective from

15 producers and certifying agencies.

16 And, finally we really want to try

17 to understand what would be the required use

18 of vaccines made with excluded methods. Could

19 they be legally used for eradication or for

20 emergency programs and under what

21 circumstances. So obviously this is a very

22 highly complex issue, there's a lack of
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1 clarity in a number of different areas

2 including the definition of excluded methods

3 between NOP and the manufacturers, et cetera. 

4 And so it's going to take us some time to come

5 up with a workable solution but we're going to

6 continue working on it. 

7 And I would like to now ask Nick

8 if he would have some additional comments that

9 he wants to make.

10 MR. MARAVELL: Thank you, Jean. 

11 Just for some of you out there in the audience

12 to give you a little bit of background if you

13 haven't been following this issue closely,

14 sort of how we got to where we are in

15 discussing the GMO vaccine issue is that there

16 was a previous board action recommending GMO

17 vaccines. It was reviewed by the USDA general

18 counsel. It was determined that a particular

19 process needed to be carried out in accordance

20 with the statute and the regulations to

21 evaluate it for adding it to the National

22 List. And so we received a request from the
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1 program to go ahead and evaluate this. 

2 And I just want to make it clear,

3 we are not considering a petition here. We do

4 not have a petition before us for a specific

5 vaccine or anything like that.

6 The Livestock Committee then

7 considered the issue and made a very minor

8 change to current policy which would have

9 affected the organic status of any product,

10 livestock or livestock product that received

11 a GMO vaccine as a result of an emergency

12 treatment program. And that's pretty much all

13 that the Livestock Committee recommended on

14 this.

15 We did not specifically consider

16 the impact of eradication programs but that's

17 certainly something that I think we plan to

18 explore with the working group.

19 We also recommended in a

20 resolution to the National Organic Program

21 that there would be potentially three things

22 that would be helpful to us to generate more
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1 information on, "us" being the NOSB. 

2 One was would it be possible to

3 encourage voluntary label claims on the part

4 of manufacturers to state the absence of GMOs

5 in their product and this way it would be more

6 easily accessible to a producer or certifier,

7 et cetera. And our reasoning there fell along

8 the lines of current practices whereby

9 producers are asked to provide documentation

10 about lack of GMO methods or excluded methods

11 used in let's say a seed inoculant or in seed

12 and in other products. 

13 So currently there is some

14 precedent for this type of documentation. It

15 may not be a cure-all and an end-all but

16 certainly something worth exploring.

17 Then the second thing that we were

18 trying to get more information on is would it

19 be possible to eventually end up at a place

20 whereby there was a realtime list when

21 vaccines went into be registered with USDA

22 through APHIS where it would be easy to
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1 determine is this vaccine indeed made with

2 excluded methods. So that was a second point

3 that we wanted to explore.

4 And then the third point where we

5 wanted more information is what do we know

6 about the existing vaccines that are

7 registered for use and whether or not these

8 vaccines are made with excluded methods or

9 GMOs, however you'd like to express it. So

10 those were the three things that we were

11 requesting.

12 We're hoping to continue to work

13 in those areas and come up with some answers

14 to those questions. But as I think Jean may

15 have alluded to, once you get into the GMO

16 issue it gets fairly complex fairly quickly. 

17 It's not a monolithic, there isn't one single

18 thing that's a GMO or an excluded method for

19 that matter. So I think we are still

20 exploring the parameters, how big is this

21 question and how much can we come back with,

22 but we are working on it and we hope to come
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1 up with something that can provide guidance to

2 the community in concert with the program.

3 MS. RICHARDSON: Melissa, would

4 you like to add something?

5 MS. BAILEY: No, I think that was

6 a great report, Jean. And Nick, appreciate

7 your follow-up comments there. Yes, I think

8 the only thing I would say is that it's been

9 I would say an open, collaborative

10 relationship with Jean and Nick and APHIS to

11 this point and I see that continuing. So

12 thanks for your work with us.

13 MS. FULWIDER: Okay, thank you. 

14 Any discussion? Okay. Seeing none we can

15 break for 15 minutes. We all need to be back

16 at 2:45. And if the Livestock -- Jean?

17 MS. RICHARDSON: Wendy, perhaps

18 because we're the first subcommittee reporting

19 could you explain when we might be voting on

20 the items, like on nonanoic acid for example? 

21 MS. FULWIDER: Yes, we may be

22 voting on nonanoic acid yet today but that's
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1 why I wanted to have a subcommittee meeting

2 here right during the break. And so we can

3 decide if we're going to vote today or later. 

4 So, everybody back here at 2:45.

5 (Whereupon, the foregoing matter

6 went off the record at 2:27 p.m. and went back

7 on the record at 2:56 p.m.)

8 MS. FULWIDER: Okay, we're calling

9 the meeting back to order. And we're ahead of

10 schedule a little bit so we are going to be

11 starting public comment a little earlier. 

12 I have an announcement to make

13 before that. At this time in the interest of

14 transparency if any of the board members would

15 like to share any interest related to our

16 Livestock Subcommittee proposals and announce

17 recusal would they please go ahead. So,

18 Barry, is there any? 

19 Okay, hearing none we -- hearing

20 none we will proceed with public comment. 

21 Will Fantle is up first. And Christopher, I

22 don't have a name here, from Heritage is on
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1 deck. And if you'd please state your name and

2 affiliation.

3 MR. FANTLE: My name is Will

4 Fantle. I'm the co-director, co-founder of

5 the Cornucopia Institute. I'm going to talk

6 about some livestock issues. You've got

7 copies, each of you, of our broader testimony. 

8 I'm not going to reference that. I've got

9 some additional comments and observations I

10 want to offer.

11 There are operations engaging in

12 wholesale fraudulent marketing. We've worked

13 with farmers on both sides of the U.S.-

14 Canadian border to gather information about

15 the activities of a Canadian company, Jirah

16 Mills, that has been a major supplier of feed

17 for livestock in this country. 

18 Last year under investigation by

19 the provincial authority in Quebec and knowing

20 that an audit of their company was forthcoming

21 Jirah voluntarily surrendered their organic

22 certification and that prevented the
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1 investigation, further investigation of the

2 company for the activities that they were

3 suspected of engaging in.

4 The alleged fraudulent grain was

5 being sold to the giant egg operations and

6 grain mills servicing livestock producers in

7 the Northeast and directly to Organic Valley

8 farmers. 

9 Now, here's the rub. One year

10 later they're back in business. They were

11 recently re-certified by Organic Tilth. No

12 one in Canada would touch this hot potato and

13 they're banned from selling their grain in

14 Quebec. But Jirah somehow managed to convince

15 Tilth to certify them. The get out of jail

16 free card was a voluntary surrender of the

17 organic certification. 

18 Miles talked this morning about

19 the accelerated pace of NOP investigation and

20 that's good. We need aggressive and quick

21 enforcement. But we've lost thousands of

22 acres of production of organic feed grain in
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1 the Midwest in the last several years because

2 our domestic farmers are unable to compete

3 with con artists and imports, cheap imports

4 coming in from other countries. In the real

5 world this means less organic acreage in U.S. 

6 Every NOSB meeting I come to I

7 hear so much praise and rightfully so for the

8 efforts of family farmers and others to raise

9 and grow the bounty that so many of us enjoy

10 and treasure. But family farmers in some

11 sectors are being crushed by tight to non12 existent margins. 

13 Such is the case right now in

14 dairy. Another suspect operator, Aurora Dairy

15 is a provider of private-label milk for some

16 of the biggest grocers in the country

17 including Walmart, Safeway, Costco, Target. 

18 The USDA chose to put Aurora on probation for

19 their 14 willful violations several years ago

20 but they didn't fine them one cent. But

21 somebody else did. 

22 You may have heard news recently
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1 about consumers in 30 states bringing a class

2 action lawsuit charging that the production

3 practices pictured on the pretty cartons sold

4 in these stores of cows grazing contentedly in

5 pastoral conditions really didn't match the

6 reality of the situation. That class action

7 lawsuit was settled a few weeks ago for $7.5

8 million. It should be an embarrassment to the

9 USDA and the organic community. 

10 The organic production data cited

11 by Mark Lipson also contained some interesting

12 nuggets. For example, just eight organic

13 dairies in Texas have nearly 50 percent more

14 gross sales at the farm gate than the nearly

15 certified 400 farms in Wisconsin. Eight farms

16 in Texas. There are real world consequences

17 of enforcement actions or delays of

18 enforcement actions.

19 Lastly, I want to mention the

20 Petaluma egg operation in California. You may

21 have heard that they are being sued again for

22 carton picturing of the chickens being outside
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1 and not matching the production practices that

2 are occurring at the operation. That suit has

3 been brought by an animal rights group.

4 Is this what we're coming to,

5 challenges for flagging practices from other

6 interests? 

7 MS. FULWIDER: Questions for Will? 

8 Okay, thank you. 

9 MR. FANTLE: Thanks.

10 MS. FULWIDER: Christopher. State

11 your name and affiliation, please. And

12 Mohamed Mousa on deck.

13 MR. PIERCE: Good afternoon, my

14 name is Christopher Pierce, P-I-E-R-C-E with

15 Heritage Poultry Management Services. I'm

16 located in Annville, Pennsylvania. I serve as

17 the president of Heritage Poultry Management

18 Services and we're around 5 hours from here,

19 so 2 a.m. this morning got on the highway and

20 got past Manhattan, lower Connecticut, and got

21 here real easy so it's good to see you folks.

22 Our company partners with a
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1 variety of egg companies providing technical

2 and hands-on support of egg farming in our

3 mid-Atlantic region's family-sized egg farms. 

4 We have a team of certified poultry service

5 technicians, Ph.D. poultry nutritionists and

6 a support team with the emphasis of assisting

7 our farmers group in the detailed hen

8 husbandry care of their flocks in addition to

9 being a tool to assist the farmers in meeting

10 the various organic, hen welfare, food safety

11 requirements for the farm.

12 We work with many of the family

13 farms producing eggs that are sold here in the

14 cities such as Providence, Boston,

15 Philadelphia, Washington, Baltimore and

16 Manhattan. Of all the farms we work with the

17 families own the farms, personally provide the

18 care and management for the flocks as well as

19 pack the eggs, 7 days a week, 365 days a year

20 meanwhile raising their own families on the

21 farm. 

22 So an important fact to share with
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1 the board is that the average age of our

2 organic farmer is probably around 35. And due

3 to the increased demand of organic eggs

4 there's new opportunities for that next

5 generation family farm.

6 Our organic farmers are motivated

7 and committed to meeting the consumer's

8 expectations while meeting the increased

9 defined welfare and food safety requirements

10 that our farms follow.

11 I serve also another position as

12 the chairman of the Pennsylvania Egg Quality

13 Assurance Program which is a program which its

14 standard was used to introduce the FDA Egg

15 Rule which was implemented and followed. The

16 reason that we've had PEQAP is the great

17 importance for successful food safety offers

18 our egg farmers, processors and the end

19 consumers and that's why the FDA used it to

20 turn into their mandatory compliance program. 

21 Because all consumers expect and should

22 receive the safest eggs that can be produced
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1 whether they're organic or not. 

2 It was our decision to participate

3 in that voluntary PEQAP program which is the

4 most rigorous egg safety program in the U.S.

5 that besides all the other details includes

6 two unannounced visits by our Department of

7 Agriculture every year. Why do we do that? 

8 Because we're committed to producing and

9 providing the highest quality eggs for the

10 marketplace.

11 In addition, the detailed farm

12 management plan encourages the farms to follow

13 good practices for salmonella risk reduction. 

14 Vaccination is an important and valuable tool

15 that even FDA encourages. 

16 In addition, many national grocer

17 retailers also have specific requirements for

18 our flocks, that they must be vaccinated on an

19 FC program at the pullet stage and that's in

20 response to 2010 where half a billion eggs

21 were recalled from two Iowa farms. And that

22 was due to that, that the retailer now cares
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1 more about where are those eggs coming from,

2 what was the vaccination program and they

3 mandate that there must be salmonella

4 vaccination programs. 

5 So I want to encourage the NOSB

6 and the NOP to support standards that provide

7 organic egg farmers with known and effective

8 countermeasures including salmonella

9 vaccination that support future success in

10 those small organic family farms that have

11 committed their lives to organic egg farming. 

12 Thanks to the NOSB and to the NOP for allowing

13 me to share this opportunity and happy

14 birthday, NOP. 

15 And if there's any comments on

16 omnivore diets I'd like to throw some comments

17 back to Mac or anything else that I could be

18 helpful today.

19 MS. FULWIDER: Questions? Mac.

20 MR. STONE: I want to acknowledge

21 that wasn't a setup so I may not be asking. 

22 But what are your growers doing with the high
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1 cost of feed and grains? Are you looking at

2 alternative grains or alternative protein

3 sources?

4 MR. PIERCE: You know, and we're

5 at historic prices. As I'm sure everybody in

6 this room knows we're at just unthinkable

7 prices. So at this point we're absorbing that

8 price. 

9 And one of the questions you asked

10 one of the commenters earlier, Mr. Robinson

11 from Kramer Feeds, was what is the effect of

12 the methionine. And one of the initial

13 effects that we have the cap on methionine is

14 we're being forced to raise the protein level

15 in our feed so that we can get the birds so

16 that they can obtain higher methionine. And

17 the birds aren't utilizing all that protein so

18 it is kind of passing through the bird into

19 the soil, into the ground, as well as it's

20 raising the cost of our feed then also. 

21 Did you ask about insects, Mac? 

22 Did I hear you ask about that? I'd love to
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1 respond to that. So actually, insects are a

2 major challenge for us because the Food and

3 Drug Administration which oversees all the

4 farms that we work with. Any farm of more

5 than 3,000 hens is overseen. They want us to

6 get rid of the vectors. We can't even use

7 insects because they could potentially be a

8 carrier of a salmonella so we have to put in

9 our action plan how to eliminate insects of

10 all types including darkling beetles and any

11 insects on the farm.

12 If there's any questions on like

13 the omnivore diets. But anyway, I'll just

14 leave it the way it is.

15 MS. FULWIDER: All right, thank

16 you. 

17 MR. PIERCE: Thank you.

18 MS. FULWIDER: Mohamed, can you

19 come up, state your name and affiliation. And

20 Brennan Herbruck on deck.

21 MR. MOUSA: Good afternoon,

22 everybody. Thank you for your hard work, NOSB
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1 members and also NOP program. 

2 My name is Mohamed Mousa. I am

3 vice president for production at Herbruck

4 Poultry Ranch. We're talking about genetics

5 and GMOs. I have a degree in genetics and

6 poultry disease or poultry medicine. 

7 I want to start here with a slide

8 I obtained from CDC. The foodborne diseases

9 in United States is about 19,089 in 2010,

10 4,247 with hospitalization and 68 fatalities,

11 68 people dead. Salmonella accounted for

12 8,256, about 43 percent from that number and

13 hospitalization from salmonella species was

14 2,290 and 29 fatalities. It's about 42

15 percent from foodborne disease. 

16 I would like to make sure that I

17 am very clear when I talk about vaccine. 

18 There's two types of vaccine. There is viral

19 vaccine against viruses and there is against

20 bacteria. 

21 Last meeting I stood and I said I

22 don't know how they make the vaccine. Well,
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1 today I can tell you how they make it because

2 I went and I visited the vaccine companies. 

3 I met with several of the specialists who make

4 that vaccine and I will make my comment here

5 about salmonella.

6 There is not any salmonella made

7 vaccine in United States is GMO. This

8 statement I clarified it from all the vaccine

9 companies making the vaccine. For Lohmann

10 Animal Health and I took their permission to

11 mention their names, the person whom

12 discovered that vaccine and manufacture it and

13 patent it with USDA, her name is Sandra Kelly. 

14 She's a colleague, she's a friend and I had to

15 take her permission also to mention her name.

16 She found out how to make vaccine

17 by accident. She was tried to suppress the

18 salmonella typhimurium bacteria and she found

19 out that there is a virus available in the

20 environment called the bacteriophage can

21 disable that bacteria. Disable means I want

22 to take you with me here, everyone from us and
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1 all ourselves, we have genetic makeup. All

2 those genetic have genes on them in the

3 chromosomes. They have switches. You can

4 turn them on and off like this light here. 

5 She succeeded to find the bacteriophage to

6 turn two genes off, means to disable the cell. 

7 And she obtained vaccine by this way.

8 Other companies which they did not

9 give me permission to mention their names,

10 they're using techniques similar to that or

11 use a different technique which is similar

12 which also through the pH and other treatment

13 they turn also the same two genes off. 

14 So this is not GMO. It happen in

15 any composting pile behind your house or my

16 house. So please, if somebody stand over here

17 I researched that, okay? I researched it. I

18 am a geneticist, I know what I'm talking

19 about. Somebody stand over here and tell you

20 that the salmonella vaccine GMO, don't believe

21 him. Refer him to me. 

22 If you need Dr. Kelly's phone
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1 number, email, I can provide it with you. I

2 have it.

3 The other issue I want to talk to

4 you about is the viral vaccine. The viral

5 vaccine, there is GMO vaccine in the viral

6 vaccine. How they do it? They slice part of

7 the chromosome from a virus, what they call

8 it. Empty space we call it in genetic, empty

9 space in that chromosome. They take that

10 empty space and get another virus and they put

11 a piece in there. When you vaccinate the

12 chicken the immune system of the birds

13 summarize that and recognize it and develop

14 immunity against it. 

15 Any questions? 

16 MS. FULWIDER: Calvin.

17 MR. WALKER: Dr. Mousa, I have one

18 question with two parts. Methionine. Could

19 you speak to the impact of the step-down?

20 MR. MOUSA: Yes, sir.

21 MR. WALKER: And in the absence,

22 what would be other alternatives in the
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1 absence of synthetic methionine?

2 MR. MOUSA: Thank you. The birds,

3 if you have 10,000 chickens they will eat

4 approximately 500 pounds of feed in their

5 lives. Two pounds of methionine per ton,

6 that's about 1,000 pounds of methionine. 

7 Because we are restricted now to use only

8 maximum of 2 pounds in early of the bird life

9 when they are pullets growing or when they

10 start laying, and when they start laying, by

11 about 30 weeks or so this is the maximum

12 production. They need maximum amount of

13 methionine.

14 In the front of the bird life we

15 have to watch for the stage of life. And in

16 your comment in many NOSB literature I read

17 there is a stage of life that you watch for

18 the stage of life. Well, in methionine sorry

19 to say you did not. And those birds that's

20 going to suffer a lot in early life but we

21 don't need 2 pound after 45 weeks or 50 weeks

22 of age. We need only less than a pound after
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1 60 weeks. 

2 I would ask the board to consider

3 the average. We don't need more methionine,

4 we just need the average. Right now those

5 10,000 birds will use only about 75 percent

6 from the allocated protein methionine only. 

7 Only 75 percent. We cannot use the other 25

8 percent because we are restricted and the

9 certifier of course will not accept the

10 average unless there will be a ruling with

11 that.

12 The alternative. Somebody was

13 talking about fish meal. I want to tell that

14 person who have that idea in their mind don't

15 destroy the organic egg production. As soon

16 as you feed high level of fish meal to get

17 methionine the brown birds is very unique. 

18 They take the fish smell and scent and put it

19 in egg. The consumer is going to run away

20 from our organic eggs. Please don't do it. 

21 I did that. I did research, that was my

22 research when I was in school. Don't do it.
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1 The other issue is the insects. I

2 think Chris commented on that. The insect

3 meal is a phenomena. Guys over there in China

4 did that and they had a lot of salmonella in

5 the eggs, a lot. 

6 The other issue which is also very

7 critical here, we have to look for the food

8 safety. We have to look for human who's going

9 to use that egg. We cannot contaminate the

10 egg by trying to supply the birds with

11 methionine. Can't do that. Thank you.

12 Any other questions?

13 MS. FULWIDER: Jean.

14 MS. RICHARDSON: Thank you. 

15 Earlier today we heard that broilers and

16 turkeys can be given before hatching bunches

17 of vaccine which I found very interesting. 

18 What I'd like to know from you is in your

19 experience how common that is.

20 MR. MOUSA: Yes. In ovo vaccine

21 is common in broiler industry. It's for viral

22 vaccine. You cannot vaccinate bacteria in the
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1 egg. The immune system of that undeveloped

2 embryo is not capable of dealing with the

3 bacteria I will say yet because some research

4 working on that right now to try to see if

5 they can have some bacteria cells treated

6 certain ways and to be in ovo.

7 For the broiler industry we use

8 all males and females. In layer industry we

9 can't do that. Even if we vaccinate in ovo we

10 have to vaccinate again because the shelf life

11 of broilers is very short, you know, 6-7

12 weeks, but layers live about 14 months. So we

13 have to build the immune system. In layers we

14 build the immune system. We vaccinate about

15 9 times and some companies vaccinate 12. And

16 we have a very broad viral and bacteria we

17 vaccinate against and we can't do it all in

18 ovo because the immune system at that time

19 will not recognize it.

20 MS. FULWIDER: Any other

21 questions? Okay, thank you.

22 MR. MOUSA: Thank you.
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1 MS. FULWIDER: Brennan Herbruck? 

2 Okay, if Brennan's not here I have Ashley

3 Swaffer next on my list.

4 MS. SWAFFER: Hello, my name is

5 Ashley Swaffer and I'm the operations manager

6 for Arkansas Egg Company. And I'm here today

7 to comment on the Livestock Committee's

8 omnivore diet discussion document. 

9 The committee has asked if they

10 should look to allow 100 percent organic meat

11 byproducts. My response is no. 

12 My first reason is the commercial

13 availability of the product, or lack thereof. 

14 For the estimated 8 million laying hens and 7

15 million replacement layers growing right now

16 you would need approximately 68 million pounds

17 of a product that's not even being certified

18 or produced right now.

19 And the second reason I'm against

20 the feeding byproducts to poultry is the fact

21 that many producers and marketers have built

22 brands centered on feeding a vegetarian diet. 
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1 Consumers are buying eggs that are fed a

2 vegetarian diet right now and they expect that

3 every time they go to the grocery store and

4 buy a carton of eggs. So I really feel that

5 the organic brand would be at risk and be

6 damaged if we fed byproducts to poultry.

7 And the discussion document has

8 also suggested we look at fish meal as a

9 solution. The problem with fish meal as

10 Mohamed said, it causes a flavor transfer into

11 eggs. And another product of fish meal is

12 that it's not an environmentally sustainable

13 resource. We should not have to use our

14 ocean's resources to feed chickens when we

15 have other options available.

16 The document also asked if the

17 committee should continue research efforts to

18 find natural alternatives to synthetic

19 methionine and I say yes. We need something

20 we can feed to our hens that meet their

21 nutritional needs in the organic regulations. 

22 But there is not a solution right now to
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1 synthetic methionine. And the maximum levels

2 put into place without a solution that is

3 commercially available to producers is

4 unacceptable. 

5 Currently the 2-pound maximum

6 level does not meet the nutritional needs

7 required by chickens which is in direct

8 violation with 205.238(a) which states you

9 have to feed a diet that is nutritionally

10 adequate. Without commercially available

11 natural methionine sources to poultry

12 producers I ask you to please seriously

13 consider the new petition submitted by the

14 methionine task force at the spring 2013

15 meeting with the revised levels that meet the

16 changing demand in methionine as it relates to

17 age. Thank you.

18 MS. FULWIDER: Harriet. Dave

19 Carter on deck.

20 MS. BEHAR: I am Harriet Behar,

21 organic specialist with the Midwest Organic

22 Sustainable Education Service (MOSES) and we
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1 work with a wide range of organic farmers

2 mostly in the upper Midwest doing education

3 and advocacy. MOSES is also a NOC member.

4 I appreciate the Livestock

5 Committee's discussion document on the

6 omnivore diet aspect of poultry and non7 ruminant animals and your wish to find an

8 alternative to synthetic methionine. However,

9 I do not believe that the use of poultry in

10 mammalian slaughter byproducts as a means to

11 provide this nutrient is workable or the right

12 direction to take.

13 I believe many consumers are

14 attracted to organic livestock products

15 specifically because of the prohibition of

16 slaughter byproducts as feed sources for

17 organic livestock. We have learned that

18 diseases can cross species with devastating

19 results with Mad Cow disease as one example. 

20 This alone should rule out the use of

21 slaughter byproducts even if they are organic. 

22 The usual infrastructure for
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1 slaughter byproducts would need to be

2 significantly improved in order to meet

3 organic standards of livestock feed handling. 

4 And if there is any fish meal used it must be

5 NOP certified organic.

6 Hogs and poultry are omnivores and

7 it is their natural behavior to consume meat

8 products. However, in their natural life they

9 would not be consuming meat every day. They

10 are opportunistic in their eating habits but

11 would not necessarily obtain mammalian or

12 poultry food sources on a daily basis.

13 I do not believe it serves farmers

14 or consumers in the long term to have a rule

15 change to allow this feeding. Instead, we

16 should be putting our resources toward the

17 research and ramping up of non-synthetic

18 methionine options. I am concerned that by

19 allowing this we would become complacent that

20 the synthetic methionine problem has been

21 solved and that our search for non-synthetic

22 plant or invertebrate methionine sources would
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1 no longer be a priority.

2 Pet food standards should be more

3 clearly defined by the NOP before adding

4 materials to the National List so we have a

5 framework on how best to list them, preferably

6 individually and not as a category, and

7 provide clarity on the manufacturing protocols

8 of these organic pet foods.

9 I would like to encourage the NOSB

10 to join me in asking the National Organic

11 Program to move forward with the NOSB

12 recommendation on apiculture. This has

13 disappeared from the NOP working list kind of

14 like the honeybees who have succumbed to

15 colony collapse disorder. 

16 Right now there is organic honey

17 being sold in the marketplace with widely

18 differing standards which is confusing to the

19 consumers and damaging to the overall organic

20 label and consumer confidence. My cab driver

21 even talked about it on my way here. Your

22 recommendation to the NOP was a good one and
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1 should be added to the NOP 2013 working list.

2 I support the committee's position

3 to not approve nonanoic acid for 205.603. 

4 And last of all, as an overall

5 caution, pay attention to what has happened

6 with Chilean nitrate at sunset and how

7 difficult it can be to remove a previously

8 allowed item from use due to the economic

9 ramifications of that removal. Whenever you

10 may think that an item that still has some

11 conserved could be approved now would have

12 thought that the future NOSB could remove it

13 with new information this removal may not be

14 as easy as you think. 

15 I agree with Kevin Engelbert that

16 votes should be done on the last day to allow

17 the NOSB to ruminate on these proposals and

18 public comments over a few days instead of

19 doing them immediately after your discussion. 

20 And I agree with Alexis from the

21 Organic Consumers Association that the current

22 use of GMO vaccines in organic livestock
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1 production is an issue of great concern and

2 the NOP should be working with certifiers to

3 get a listing of all vaccines currently in use

4 so the working group can see what vaccines

5 they should review as a possibility from

6 excluded methods. 

7 And if you want to know more about

8 the Minnesota Supreme Court decision about

9 denying pesticide drift as damage to an

10 organic farm ask me. 

11 MS. FULWIDER: Questions? John.

12 MR. FOSTER: In thinking about

13 alternate food sources for I think

14 particularly poultry in this case if we came

15 to a world where insects and earthworms became

16 readily available as a food source, a provided

17 food source, not just the ones you might find

18 in the pasture but ones that would be raised

19 for that purpose would those earthworms and

20 insects and other invertebrates need to be

21 certified organic?

22 MS. BEHAR: Well, that has been --
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1 I remember a few years ago we did talk about

2 that actually with ATTRA. There was a whole

3 group of farmers that were raising red worms

4 and we were trying to figure out if earthworms

5 were livestock and whether they would then

6 have to be fed organic feed to then be

7 considered, they themselves.

8 MR. FOSTER: Right. What's your

9 opinion about that?

10 MS. BEHAR: Well, I think that

11 there can be a system produced where the

12 invertebrates are consuming foods that are not

13 toxic. I don't know necessarily they would

14 have to come from organic feedstocks. But I

15 think that we need to be creative and be

16 looking as much as possible at producing

17 livestock feeds that have the least amount of

18 risk to the consumers and to the livestock

19 themselves.

20 MR. FOSTER: Okay, but should they

21 be certified organic? I mean, I hate to put

22 you on the spot. You're one of the most
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1 knowledgeable people in the room about it.

2 MS. BEHAR: Well, I would think

3 actually the regulation would mandate that. 

4 There would have to be a determination if bugs

5 and earthworms are livestock. But I would

6 imagine if they are being raised, I mean you

7 kind of went through this a little bit with

8 yeast, you remember.

9 MR. FOSTER: Oh, I know.

10 MS. BEHAR: Whether, you know,

11 something that's actually being agriculturally

12 produced is then livestock or plant or what is

13 it.

14 MR. FOSTER: Right, the intended

15 use plays into what production practices might

16 be necessary. Right. Totally there with you.

17 MS. BEHAR: Yes.

18 MR. FOSTER: But from your opinion

19 or MOSES, whomever you choose to represent,

20 should they be certified organic. If so, what

21 standard?

22 MS. BEHAR: Well, we never came to
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1 the answer whether or not earthworms were

2 livestock. That was not really part of a

3 larger community discussion. So I don't have

4 the answer whether earthworms are livestock or

5 not, but I would think that they could be

6 raised organically, yes. So if someone could

7 raise them organically then they should be

8 able to be certified.

9 MR. FOSTER: Close enough. That's

10 cool. Thanks.

11 MS. FULWIDER: Mac.

12 MR. STONE: Well, this came up at

13 lunch the other day and the definition of

14 livestock includes a clause that says other

15 non-plant life. So yes, the insects,

16 earthworms would have to be organically

17 managed.

18 MS. BEHAR: Okay, let's raise some

19 crickets.

20 MS. FULWIDER: Miles.

21 MR. MCEVOY: Yes, in my

22 presentation this morning I only gave you a
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1 tidbit of the things that we're working on. 

2 We actually are working on apiculture. We

3 actually have the preamble that's being

4 reviewed by an ARS -- at ARS right now. So it

5 is on the work plan, we're working on it. 

6 Whether or not we get a proposed rule out next

7 year or not depends upon lots of different

8 factors but it's on the work plan.

9 MS. BEHAR: Thank you. I just was

10 disturbed to not see it on the list.

11 MS. FULWIDER: Thank you. Oh,

12 Jay.

13 MR. FELDMAN: This may be a little

14 out of sequence but since you're here I might

15 as well try this. I'm trying to sort of get

16 an amplification on your position that trying

17 to revisit something when more information

18 becomes available is a difficult process so

19 that putting something before the board

20 before, you know, it's ripe and fully

21 understood becomes problematic under the

22 supposition that we may in intervening years
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1 acquire information that we could then apply

2 to an adjustment or a revision of that

3 original decision. So you've seen that be

4 problematic over the years.

5 MS. BEHAR: Well, especially if

6 you say well, we'll put this on the National

7 List now because it looks okay although we

8 have some unanswered questions. And if

9 something comes up in the intervening 5 years

10 then we'll take it off the list. But my

11 caution is it's very difficult to take things

12 off the list. And so unless you're very

13 secure in your decision-making you probably

14 should defer until you get that information.

15 MR. FELDMAN: And as a follow-up,

16 if we're working on a complex issue like we

17 are in this class of biodegradable film mulch,

18 bioplastic, whatever we call it, and let's say

19 we want to, you know, address some of the

20 complexity with some guidance. 

21 From a certification and

22 inspection standpoint what level of assurance
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1 would this board have that that guidance,

2 assuming -- let's assume hypothetically that

3 it came out perfectly, that that guidance

4 would be instructive and enforceable enough as

5 opposed to putting the specificity into the

6 annotation or in somewhere else somehow in the

7 rule.

8 MS. BEHAR: I think that for

9 clarity and transparency for the purchasers of

10 the material, for the manufacturers of the

11 material and for the certifiers that needs to

12 be in the regulation. Because in guidance

13 that kind of gets lost, it doesn't have the

14 rule of law and not everyone's going to know

15 to go look to guidance. If a producer is

16 looking to figure out what kind of biofilm

17 they can use they're going to go to the

18 regulation. 

19 They're not going to go back to

20 the minutes of the NOSB, they're not going to

21 go to the NOP program manual, they're going to

22 look at the regulation because that's enough
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1 for them to read. 

2 And the certifiers are also not

3 going to feel like they can enforce anything

4 unless it's in the regulation. Miles has a

5 response.

6 MS. FULWIDER: Miles.

7 MR. MCEVOY: Guidance in and of

8 itself is not enforceable. It has to be

9 backed up by the regulations. So you can't

10 make a regulation through guidance. Guidance

11 provides a method to comply with a regulation. 

12 And so it basically gives you a path to

13 compliance and if you're not in line with the

14 guidance you have to demonstrate how you're in

15 line with the regulations. But it always

16 comes back to the regulations, that's what's

17 enforceable. If it's not in the regulations

18 then there is limited enforceability.

19 MS. FULWIDER: Thank you. Dave,

20 state your name and affiliation and we have

21 Sharon Sherman on deck.

22 MR. CARTER: Thank you. My name's
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1 Dave Carter. From time to time I've been here

2 with the National Bison Association or Crystal

3 Springs Consulting. Today I'm here as a

4 consultant on behalf of the Pet Food

5 Institute. 

6 And I just want to say that I

7 think myself and Kim Dietz are probably the

8 only two former NOSB members that were here in

9 October of 2002 so it's especially a great

10 birthday for the organic program.

11 I want to talk a little bit about

12 both the materials and the rulemaking for

13 organic pet food. The pet food category,

14 Miles said this morning that it's important to

15 talk about the economic impact of a category. 

16 And the organic pet product is between $210

17 and $240 million. About 30 percent of that is

18 food, the rest is treats and other materials. 

19 And I think that that's pretty

20 amazing given the roller coaster that the

21 folks who make those products have been on for

22 the last 8 years. Two thousand and four, the
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1 Secretary of Agriculture said you cannot

2 certify pet food as organic and then she said

3 well, maybe you can but you've got to certify

4 it under the human food standards. 

5 There was a pet food task force

6 set up that noodled around for awhile, took it

7 to the NOSB. The NOSB filed their report in

8 2008 and we're kind of moving on since then.

9 In the meantime, the whole issue

10 of accessory nutrients and vitamins came about

11 in terms of what can and can't be in because

12 we're under the human food standard. So you

13 can see that those folks that are out there

14 trying to do this and build this have been

15 pounding that square peg into that round hole

16 consistently. It's a lot of dedication to

17 build this sector.

18 In terms of well, let's let the

19 regulations get set before we address the

20 materials we think we need to follow a

21 parallel track. Miles, I'm very pleased this

22 morning that you reviewed the progress that's
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1 being made in developing the pet food

2 standards and what's going on there. 

3 But without having clear,

4 consistent regulations and the knowledge of

5 what you can and can't put in those products

6 it doesn't do any good. You have to remember

7 that with pet food we have one or two chances

8 every day to get it right. Unless that

9 product can be labeled as a complete and

10 balanced diet it has to be labeled as

11 intermittent and supplemental. It can't be

12 listed as a food and that's only right because

13 those pets require that nutrition. So we're

14 very concerned that we have the things that we

15 need to make that. 

16 The NOSB reports in 2008 gave a

17 list of materials that would likely have to be

18 petitioned and that's why after filing the

19 initial petition for taurine then we came in

20 with the petition as a category.

21 Now, I think that -- I don't think

22 there's any argument about these being
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1 essential or required. Remember, other

2 categories you talk of being accessory

3 incremental. Pets, it's essential and

4 required. I think the debate has been can we

5 get those from natural sources or not.

6 The Livestock Committee has said

7 well clearly they don't think that taurine for

8 cats falls into that category. Clearly

9 taurine is the critical one. But I think when

10 you look at taurine not only are not dogs and

11 cats all the same, all dogs are not the same,

12 all cats are not the same. And if you look at

13 the literature there's a lot of literature

14 that talks about the inability of large breed

15 dogs like Newfoundlands and the others to

16 synthesize taurine. 

17 Also, remember that the things

18 that were in the TAP report that were cited as

19 an example were conventional companies. The

20 conventional manufacturers have a larger array

21 of ingredients, particularly chicken meal. 

22 There is no source of certified organic
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1 chicken meal and so it's much more difficult

2 for those folks to formulate those products. 

3 And the products that are out

4 there in terms of the food that certified

5 organic are a very narrow range, primarily

6 adult dog maintenance. And if every pet out

7 there was an adult dog we needed to maintain

8 that would be fine, but we've got cats, we've

9 got puppies, we've got seniors, et cetera and

10 so on. So thank you very much.

11 MS. FULWIDER: Questions? Jay.

12 MR. FELDMAN: Thank you, Dave. 

13 I'm trying to understand this citation in the

14 technical review that cites nature's logic. 

15 You're probably familiar with that brand. And

16 they cite a full -- well, meeting AAFCO

17 nutrient standards thereby making their

18 products complete and balanced. And so I'm

19 trying to put that in perspective given what

20 you've said. Can you clarify?

21 MR. CARTER: Without looking at

22 that specific one there are (a) the companies
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1 that have been formulating the complete and

2 balanced products using the materials that

3 have been allowed previously. And then there

4 are the ones that are doing the products but

5 not the full line of completely certified. A

6 lot of the products are in the made-with

7 category right now.

8 MR. FELDMAN: Okay, so I forgot to

9 say that their claiming these to be natural

10 food ingredients so that -- I imagine that's

11 a slippery slope there. 

12 MR. CARTER: That's a very

13 slippery slope because you can have natural

14 chicken meal but not -- you could have

15 certified organic chicken meal, it's just that

16 we don't have it in the United States. And

17 the difference that that makes is when you're

18 formulating a product with a fresh meat or

19 poultry ingredient you're formulating it with

20 about 80 percent water in there. And so it's

21 very variable, it's very difficult to bring

22 that about. 
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1 If you can use the chicken meals

2 which is that dried product you can test that,

3 you can have a very consistent product there. 

4 It gives you a lot more flexibility. And the

5 folks that are doing that under the organic

6 have kind of got one hand tied behind their

7 back in terms of that just because of the

8 availability. It's not a price factor, it's

9 just that it's not available.

10 MR. FELDMAN: If you take a

11 product like this which says that it contains

12 no synthetic ingredients according to the TR,

13 you know, and we, let's say the board is

14 interested in creating an incentive for

15 organics to fill that niche in terms of

16 natural food ingredients. Could it

17 conceivably be produced to create -- to meet

18 these AAFCO standards without synthetic

19 ingredients?

20 MR. CARTER: Theoretically,

21 perhaps. Right now I don't think anybody's

22 cracked the code. I mean, that's the problem
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1 is we just don't have it, you know. And the

2 folks that are out there are doing it because

3 of this byzantine process -- excuse me, Miles,

4 nothing -- but it's just been this process,

5 you know, since 2004. And then without having

6 the access.

7 And one of the things that I

8 noticed from the TAP report was, you know, the

9 TAP report for example noted that you could --

10 that raw food was perhaps a viable alternative

11 although they do have this little provision,

12 concerns with feeding pets raw food include

13 risk of contamination from salmonella, E.

14 coli, and other pathogens, bacteria, dietary

15 imbalances and internal injuries from sharp

16 bones. Some dogs have reportedly died from

17 bacterial poisoning. 

18 I always hate something that says,

19 you know, this is really good for you except

20 you could die from it. So you know, I just,

21 I think what we want to do is make sure that

22 we're getting the best thing out there and
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1 really helping to build this sector.

2 And I would just say one other

3 thing too, that the folks that have really

4 been out in front of developing the organic

5 pet food have been a lot of the smaller

6 companies that have done this because of their

7 commitment to it through the years. Noticed

8 how I whipped in some of my testimony I didn't

9 get to give there.

10 MS. FULWIDER: Mac?

11 MR. STONE: Dave, is there a

12 relationship for the need for methionine in

13 lysine relative to the -- in formulating

14 relative to the grain component versus the

15 meat or poultry component in those feeds?

16 MR. CARTER: Well, there are, and

17 I think that, you know, some of the things --

18 I listened with interest to some of the

19 previous discussion of well, fish meal and

20 some other things would be a good source of

21 that. And it gets into those, you know, the

22 same arguments as do we really want to be
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1 going down a path with something that could be

2 environmentally unsustainable in order to meet

3 those.

4 MS. FULWIDER: Okay, thank you.

5 MR. CARTER: Just one last thing. 

6 When it comes to if you're classifying insects

7 as livestock I want to see the squeeze shoot

8 that you work them in. So, thank you.

9 MS. FULWIDER: Sharon, please

10 state your name and affiliation, and William

11 Reifenrath on deck.

12 MS. SHERMAN: I'm Sharon Sherman

13 and I'm with the PetGuard Company. My husband

14 and I co-founded the company in 1979. We're

15 perhaps the first natural foods company to

16 create foods with byproducts, artificial

17 flavors, colors and preservatives back then. 

18 We like to be the voice for animals, that's

19 been our passion all these years. And so at

20 that time we actually created these foods. 

21 When we created foods without

22 byproducts we followed the AAFCO standards
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1 realizing that was the only way that they

2 could come to market and the safe way that

3 they needed the vitamins and minerals to be

4 able to -- for maintenance or an all-stage

5 food to make it complete. 

6 We continued on down the road and

7 I would -- I guess people like to believe, you

8 know, they have a marketing company but we're

9 not really a marketing company and that we

10 kind of like listen to what our consumers are

11 saying they need and where there's a need we

12 create a product. 

13 And such came about with the

14 organic issue. People wanted organic foods

15 for their pets. And so at that time when we

16 said, okay, well let's try to see if we can do

17 it. And this was a need for the same reasons

18 that they would eat organic foods, maybe their

19 pets had allergies, maybe that they just

20 understood the benefits of organic food and

21 wanted their pets to have it. 

22 At that time I met Katherine
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1 DiMatteo and she said these are the people

2 that you need to talk to so I met these two

3 gentlemen, Mr. Hutchinson. And then I was

4 turned onto a Mr. Jones. And I wrote a nice

5 letter and just kind of like communicated my

6 passion for being on the pet food task force

7 at the time. 

8 And my passion was, relating back

9 to creating the first foods without

10 byproducts, was I didn't want to have

11 byproducts in my organic pet foods. And I

12 didn't want anybody else to have that as well. 

13 I felt like they needed to have the same

14 standards as humans. The only difference is

15 we would be able to supply the pre-mix of

16 vitamins and minerals were necessary to

17 sustain their life because after all this is

18 all they eat. This is what we feed them every

19 single day and there's so much scientific data

20 that relates to the necessity for taurine. 

21 We saw in the nineteen eighties

22 that cats were spontaneously having heart
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1 attacks due to cardiomyopathy, or they were

2 having issues with reproduction. And they

3 could not synthesize the taurine in their

4 system. So you know, those amino acids are

5 important. The cats need the DL-methionine

6 because it acts as an acidifier. 

7 And yes, we use whole meats in our

8 products but through the manufacturing process

9 you can't seem to supply enough to sustain

10 their life in an optimum situation.

11 So, I guess I'm, you know, I've

12 come here to basically advocate for the

13 animals and of course for our work. I mean,

14 we're 34 years old. We just want to continue

15 our work and do it safely because safety is

16 the answer when you put the product out on a

17 shelf. I think that the AAFCO stage helps the

18 consumer to feel secure in what they're

19 feeding their pet. This is for maintenance

20 and this is for all stages. 

21 I can feed this to my pet and

22 they're going to produce beautiful litters,
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1 they're going to be healthy. And I think

2 anything less would be a tragic situation. We

3 love our animals. 

4 And I do appreciate your work and

5 I appreciate your time and I think it's just

6 very, very important for us to speak for them

7 because they can't speak for themselves. 

8 MS. FULWIDER: Mac?

9 MR. STONE: Does access to these

10 synthetic amino acids improve your ability to

11 source organic ingredients to build these

12 formulations, these diets?

13 MS. SHERMAN: Well, yes,

14 absolutely. Because you know, they're

15 required. I mean, you can't get enough

16 taurine and you can't get enough of the

17 methionine. 

18 MR. STONE: But if there's a lack

19 of organic inputs if you will --

20 MS. SHERMAN: Pardon me?

21 MR. STONE: If there's a lack of

22 organic chicken meal or organic beef products
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1 available how does this help you to increase

2 the organic content of the feeds?

3 MS. SHERMAN: Well, we are

4 producing theoretically because we go back --

5 we are, not theoretically, back to 2004. We

6 just followed the human standards like 95

7 percent and added the vitamins and minerals

8 required through AAFCO. So the 5 percent are

9 those ingredients. And that's how -- you

10 know, and we have functioned that way, not any

11 health issues or so forth. I mean, we produce

12 all stage foods as well as an important vegan

13 dog food that veterinarians use as an allergy

14 type of product to determine which type of

15 allergy that they have.

16 MS. FULWIDER: Thank you. 

17 MS. SHERMAN: Thank you.

18 MS. FULWIDER: William, please

19 state your name and affiliation and we have

20 Ann Petersman on deck. 

21 DR. REIFENRATH: My name is Bill

22 Reifenrath. I am the author of the petition
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1 that's before you for nonanoic acid. I'm the

2 founder of Stratacor whose sole employee

3 stands before you and I'm the inventor of the

4 C8910 mix of fatty acids that we're using as

5 a livestock fly control.

6 So this is -- the C8910 is a

7 natural fly repellant. It consists of three

8 fatty acids that are normally found on the

9 skin surface of animals and man. This

10 project, the natural fly repellant was

11 initially funded by USDA back in 2005 as a --

12 because of the lack of alternate and necessary

13 additives for IPM. And I think you have

14 testimony from three universities and South

15 Africa, from veterinary entomologists

16 expressing the same fact.

17 The 8910 repellant can be applied

18 to ranch cattle for horn fly control. And if

19 you look at this slide you can see the 8910

20 repellant can reduce the level of horn flies

21 competitive with cypermethrin, piperonyl

22 butoxin. The manufacturer of this concoction
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1 in their own words said the C8910 is the only

2 natural insect repellant to compete with

3 existing organophosphates and pyrethroid

4 repellants, insecticides.

5 This is data from Kenya where they

6 looked at malaria-carrying mosquitoes to show

7 that with a single application of the 8910

8 repellant that it will result in mortality of

9 about 90 percent for malaria-carrying

10 mosquitoes. So by treating cattle for flies

11 humans also derive a benefit in killing the

12 malaria-carrying mosquitoes.

13 Laboratory data from CDC showed

14 that C8910 was effective against Anopheles

15 gabiae, the primary vector of malaria in

16 Africa at levels comparable to other

17 insecticides approved by WHO.

18 In summary, all the components of

19 8910 are grass. The only one that can compete

20 with synthetic pyrethroids or OPs. Supporting

21 fly control for livestock producers worldwide. 

22 And I think it would enhance organic livestock
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1 production if accepted.

2 I would like to spend the rest of

3 my time, there was a report and rebuttal. 

4 There was a reference to a report by Davies

5 that said that nonanoic acid is toxic to

6 nematodes. But if you read lines 337 and 339

7 carefully from the independent report it says

8 that the authors did not report whether

9 nonanoic acid may be toxic to beneficial

10 nematode species or earthworms. However, an

11 EC review indicated that nonanoic acid is not

12 toxic to earthworms in short-term toxicity

13 tests. 

14 The independent report further

15 goes on to say that when applied to livestock

16 as an insect repellant that the environmental

17 -- because of its rapid biodegradability and

18 low toxicity that it's not likely to be an

19 expected significant contaminant to the

20 environment. 

21 MS. FULWIDER: Questions? Jean?

22 MS. RICHARDSON: Thank you. When
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1 you have -- when you apply this sort of smelly

2 oil to the livestock, you know, which is part

3 of what it is. It's a nice, oily kind of

4 smelly thing that repels the insects. How

5 often do you have to do it? When I looked at

6 the technical report it seemed like for house

7 flies the effect lasted maybe less than a day

8 and then for other flies maybe 2 to 3 days. 

9 So do you have to apply this on a

10 regular basis? And if so, can you give us

11 some idea of the actual amounts you would be

12 applying? Say if you're on a healthy beef

13 farm where you maybe have several hundred beef

14 cattle gathering in a hot sweaty day kind of

15 thing.

16 DR. REIFENRATH: Well first of

17 all, at the doses that we're using say for

18 livestock in the dust form, the use rate for

19 the 8910 dust is the same as the use rate for

20 conventional organophosphate pesticides or

21 permethrin-type pesticides. 

22 A 12 and a half pound charge of a
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1 dust bag will last for 6 weeks on a herd of 30

2 head of cattle. And that's about the rate of

3 use for the other products.

4 In terms of the -- you call it a

5 smelly oil. It's -- in the dust form at the

6 doses that we're using the odor is not that

7 perceptible. And in the context of your

8 applying it to a range cattle I don't think

9 that in the context of what it's being applied

10 to that the odor is a big issue.

11 For horses and other pets or

12 companion animals we can effectively mask the

13 odor through formulation. So I hope that

14 answers your question.

15 The work that Brad Mullens did at

16 UC Riverside for the oil formulation, a single

17 application would last approximately 2 to 3

18 days. And I think he indicates that in his

19 report to the posting on your website.

20 MS. FULWIDER: Jay?

21 MR. FELDMAN: Thank you. You

22 know, we always have around these types of
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1 materials have a debate over whether it's

2 better, what you've created here, what is

3 being produced and petitioned is better than

4 organophosphate or synthetic pyrethroid or

5 something else that's typically used in

6 conventional systems. And no doubt it is and

7 congratulations on moving a product like this

8 into the market.

9 But as you can hear from being

10 here at this meeting the standard that is

11 applied to that product is very different than

12 an IPM standard for instance, or reduced

13 toxicity assessment. And so if you -- I

14 suspect you have looked at the technical

15 review on this product. We're looking at

16 issues around impacts on beneficial nematodes,

17 beneficial organisms under this standard which

18 for instance EPA would not be looking at in

19 the context of its pesticide registration

20 program. And so we have to apply that screen

21 and that criterion to this review. 

22 The TRs looked at potential wind
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1 drift impacts on blossoms and weeds and

2 concerns over negative impact as I mentioned

3 on nematodes and earthworms. So when you put

4 that additional screen on materials that are

5 allowed in the organic system it becomes much

6 heavier in terms of allowance in that system. 

7 So what, you know, I know you've

8 studied these management systems and the

9 conclusion of those that have looked at it in

10 the subcommittee really has been that there

11 are alternative management systems that can

12 adequately control for flies or whatever the

13 endpoint is here. Do you disagree with that? 

14 Do you feel that what is available now is

15 ineffective or not productive or something to

16 the effect? 

17 DR. REIFENRATH: Well, I would

18 refer to the postings that you've gotten from

19 University of California Riverside, from the

20 University of Nebraska, from the University of

21 Arkansas and from a veterinary company in

22 South Africa that existing IPM for any kind of
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1 livestock production is inadequate. That's

2 their opinion. They're veterinary

3 entomologists. I'm a toxicologist. 

4 In response to your comments about

5 earthworms and nematodes, you know, we have an

6 old saying in toxicology that the dose is the

7 poison. So when you look at the way the 8910

8 is being applied to an animal it's being

9 sprayed directly on the animal or in the

10 picture that I showed it's being dusted on the

11 back of the animal. So the exposure to the

12 soil is minimal because we're directing it at

13 the animal. 

14 And I don't have the data with me

15 but we've done studies to look at radiolabeled

16 fatty acids that are in these type of

17 formulations and applied to soil that the

18 majority of the fatty acids will evaporate

19 from the surface. So the combination of that

20 as well as we're directing it to the animal

21 rather than we're not tilling it into the soil

22 would minimize the environmental exposure. 
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1 And I think your technical report

2 in its summary basically says that, that

3 environmental contamination is not a

4 significant issue here. So that's your

5 report.

6 MS. FULWIDER: Thank you. Ann,

7 please state your name and affiliation, and we

8 have Susan Czernicka on deck.

9 MS. PETERSON: Hello. I'm Annie

10 Peterson. I'm from Emery Oleochemicals in

11 Cincinnati. The Emery family began making

12 fatty acids in 1860. They were making them

13 for soap and for candles. So they've been

14 there for a long time.

15 I'm here to petition to allow

16 nonanoic acid as a synthetic for livestock

17 control and I'm asking that you take a new

18 look. You know, they're saying well, there's

19 not maybe an organic registration or in

20 Canada. Well, what Bill came up with, I mean

21 he's been working on but you know, any

22 semblance of a registration that we would have
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1 to even offer it or present it, it's really

2 only been completed in the last several

3 months. And it's the first step. 

4 So I mean, it's new chemistry and

5 it's something that -- it's my job when I go

6 to -- I'll go to try to make people aware of

7 the chemistry because it's soft chemistry,

8 it's natural fatty acids and it's a low-risk

9 chemistry. And you take it into somebody like

10 a major, or like a big company and they say

11 that it doesn't work. They said that can't

12 work. And then they get a sample of it and

13 they say you know, that really works. And

14 they're surprised because they think how can

15 something natural and basic and low-risk work.

16 But the Production Act, okay, OFPA

17 permits certain organic -- or certain

18 chemistries that are synthetic. And nonanoic

19 acid that Bill's been using, it's one

20 component of a blend of fatty acids that are

21 used as a tool to control biting flies, ticks

22 and mosquitoes on livestock. And the base for
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1 those, it's sustainable chemistry and it's no

2 residue and it can come from canola, some

3 parts of this can come from coconut, from beef

4 tallow, so it's all naturally sourced. It's

5 not anything that's going to have a

6 petrochemical base.

7 The -- I think one of the points

8 when we're looking at what's the basis is that

9 the material is safe, it's not harmful to

10 human health and that's supported by the DFDA

11 -- considered grass. Generally regarded as

12 safe since 1965. And it's used in very low

13 concentrations so you don't see issues when

14 you're using it because it's in such a small

15 amount. 

16 And it's not really, you know,

17 it's not a high-toxicity material. And the

18 fatty acids are naturally occurring. And none

19 of the approved essential oils or pyrethrins

20 that are considered organic are part of the

21 normal diet. The pyrethrins are highly toxic

22 to bees and fish and that's the existing
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1 products that are organic. 

2 That's not the case for the fatty

3 acids. They're a significant part of daily

4 diets. Some of the fatty acids in the 8910,

5 they're in dietary lipids. They're also

6 present in a variety of plants and fruits.

7 This material is registered, the

8 8910, Bill's product is registered as a

9 biopesticide. And it is IPM-compatible

10 because Integrated Pest Management is an

11 effective, an environmentally sensitive

12 approach that relies on a combination of

13 common sense practices. And that's cultural,

14 biological and can be synthetic means to

15 control all pests while minimizing the public

16 health and environmental risk. This

17 represents good stewardship.

18 We've got the written

19 recommendations that Bill mentioned. Peter

20 Oberem, the South African Animal Health

21 Association, he's a member of that. And it's

22 a huge boost for organic in South Africa. Ed
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1 Mullens and David Boxler, John Campbell, they

2 have 90 years experience between all four of

3 those people and they have been working with

4 the 8910 since 1999. And they are saying that

5 there really isn't any -- they are not seeing

6 any damage to the environment. They're saying

7 that it's soft chemistry and that it's

8 effective. 

9 And the last thing is cost. But

10 just -- this is a natural material and it's

11 low-risk and it's low-cost. It's less toxic

12 than what's already in some of the materials

13 in the organic program. And I want to ask you

14 to allow this material as a tool.

15 MS. FULWIDER: Thank you. Any

16 questions? Okay. Being the last commenter of

17 the day thank you and we're going to have a

18 quick break. Please, everyone, be back at

19 4:15.

20 (Whereupon, the foregoing matter

21 went off the record at 4:04 p.m. and went back

22 on the record at 4:20 p.m.)
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1 CHAIRPERSON FLAMM: Board members,

2 please take your seat. Board members, we're

3 back in business. And I'll ask the

4 chairperson, Wendy, if the Livestock Committee

5 has any proposals ready for voting.

6 MS. FULWIDER: Yes, we would like

7 to vote on nonanoic acid. 

8 CHAIRPERSON FLAMM: Do we have a

9 motion on this substance?

10 MS. FULWIDER: Yes. 

11 MS. RICHARDSON: Do you wish me to

12 read it?

13 CHAIRPERSON FLAMM: Jean? Jean,

14 are you prepared to make a motion?

15 MS. RICHARDSON: I am prepared to

16 make the motion. The first motion is

17 classification motion, that nonanoic acid CAS18 112050 as petitioned is synthetic. 

19 CHAIRPERSON FLAMM: Do we have a

20 second?

21 MR. BONDERA: Yes, I second that

22 motion.
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1 CHAIRPERSON FLAMM: We have a

2 motion which has been seconded to classify

3 nonanoic acid as synthetic. I believe we're

4 prepared to vote starting with Jennifer

5 Taylor.

6 MS. TAYLOR: Isn't there

7 discussion on motions? 

8 CHAIRPERSON FLAMM: We can have

9 discussion on the motion to classify, yes. If

10 you would like to have discussion. Okay. I

11 didn't think there was need for it on the

12 classification, but thank you. So we're

13 prepared to vote on the motion to classify

14 nonanoic acid as synthetic beginning with

15 Jennifer Taylor.

16 MS. TAYLOR: Yes.

17 MR. MARAVELL: Yes.

18 MR. FELDMAN: Yes.

19 MS. SONNABEND: Yes.

20 MR. STONE: Yes, sir.

21 MS. FULWIDER: Yes.

22 MR. AUSTIN: Yes.
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1 MS. FAVRE: Yes.

2 MS. BECK: Yes.

3 MR. FOSTER: Yes.

4 MR. DICKSON: Yes.

5 MS. RICHARDSON: Yes.

6 MR. WALKER: Yes.

7 MR. BONDERA: Yes.

8 CHAIRPERSON FLAMM: And the chair

9 votes yes. Do we have a motion to list the

10 material? 

11 MS. RICHARDSON: The listing

12 motion is to add nonanoic acid CAS-112050 to

13 Section 205.603 as an insect repellant

14 insecticide.

15 CHAIRPERSON FLAMM: Do we have a

16 second? 

17 MR. BONDERA: I'll second that

18 motion.

19 CHAIRPERSON FLAMM: The motion has

20 been seconded. Discussion on the motion. 

21 John?

22 MR. FOSTER: I have a pretty good
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1 feeling how this will end up going but I feel

2 like I just, I want to say the information

3 about the toxicity relative to beneficial

4 nematodes, or any nematodes for that matter,

5 or earthworms seems still like a maybe to me. 

6 And I'm not a huge fan of voting down a

7 material for a maybe, particularly when the

8 use of the material leads me to believe

9 there's minimal contact. 

10 And if a material is so ephemeral

11 as to need to be required many times to be

12 effective it can't be that persistent. And it

13 seems to me based on granted a limited amount

14 of time of me working on cattle ranches just

15 the kind of environment would lead me to

16 believe the material would degrade pretty

17 quickly. 

18 Another argument I've heard is

19 that not a lot of producers are screaming for

20 the material. And that's marginally

21 compelling to me because if it's not listed a

22 lot of organic producers in organic production
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1 environment don't have access to it right now. 

2 So a lot of producers wouldn't have the

3 experience, wouldn't have the option of using

4 it. I understand that that's not, you know,

5 that's not a complete -- I understand it's not

6 a perfect rationale but I do know that a lot

7 of materials are useful for a lot of people

8 but not everyone. 

9 And it's hard for me to believe

10 that a whole lot of producers are going to be

11 real vocal about a material that they've never

12 had experience with, hands-on experience with,

13 because most of my experience with producers,

14 both livestock and crop producers is that they

15 really don't believe it until they see it with

16 their own eyes. 

17 So it makes sense to me that there

18 wouldn't be an outcry for this material just

19 on sheer numbers? Most people haven't

20 experienced it. Most organic producers don't

21 have experience with it. So I'm reluctant to

22 say because there's no outcry it's not a good
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1 enough reason to try it.

2 It does sound to me that there is

3 pretty good evidence that this is a preferable

4 material to other things in current use. 

5 That's pretty compelling to me. And I'll

6 leave it there.

7 CHAIRPERSON FLAMM: Any other

8 discussion? Zea, do you have a point you

9 wanted to make?

10 MR. FELDMAN: I raised my hand. 

11 Just to respond, I mean I think as I said, you

12 know, the fatty acids are used extensively in

13 IPM systems and I understand all that. Again,

14 I feel we have a higher burden to establish

15 need and essentiality which doesn't, you know,

16 I just -- unless someone can show me something

17 I missed here in the comments I just don't see

18 that need established. And -- except from the

19 purveyor of the material which is fine. But

20 I think we have a statutory duty to establish

21 that need before we introduce a synthetic into

22 the organic system. 
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1 And that hasn't -- you know, I

2 don't think we've done that. We may be able

3 to do that in the future but we haven't done

4 it to date. So, on that count I would say

5 that we should vote this down and seek out

6 more information on need and also alternatives

7 as well.

8 And to the issue of establishing

9 hazard, you know, especially under the OFPA

10 standard you know when we talk about an

11 insignificant impact on beneficial organisms

12 in a situation where there is some non-target

13 exposure and there's an admission that there

14 is some. Whether it's deemed significant or

15 not is always going to be the issue of course. 

16 But again, when you take that factor into

17 account with the lack of established

18 essentiality or need for a synthetic under

19 OFPA I don't think we have much of a choice at

20 this time. There may be better data that

21 comes along in the future.

22 CHAIRPERSON FLAMM: Any other
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1 comments? John, do you want to have a follow2 up?

3 MR. FOSTER: The -- in terms of

4 alternatives I think the regulation covers

5 alternatives really well actually in 206. 

6 This material or any chemical control wouldn't

7 be in play unless everything else in 206 ahead

8 of it were covered and found to be wanting. 

9 So I agree, there are other alternative

10 management practices. The whole context --

11 we've talked about this at least for 2 and a

12 half years -- is that these materials, pest

13 control materials shouldn't come into play

14 unless those alternatives have been exhausted. 

15 That's why there is this, the only

16 codification of mandated IPM I can find is

17 here, is right there in the regulation,

18 206(a)(b)(c). It's not till you get down to

19 (e) that you're even allowed to try this

20 stuff. So yes, there are alternatives, but in

21 the context of the whole it's not just a

22 matter of this material, it's that these other
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1 things are found wanting. 

2 So I want to make sure everyone's

3 clear. I'm not saying there's no alternative. 

4 There are. Many of them are listed in the

5 regulation and my expectation would be that

6 those are demonstrated to be ineffective, or

7 at least ineffective here and there. 

8 And the here and there is the part

9 where I get a little itchy assuming that

10 people who haven't had the opportunity to try

11 it because it isn't listed are somehow

12 expected to clamor for it. That's just not

13 the nature of producers that I know. Maybe

14 there's -- I'm sure there's other growers and

15 other livestock raisers that do things

16 differently. But my experience is that until

17 they see it used very few are going to start

18 pounding on the table for it to demonstrate

19 that need. I think it's something of a catch20 22 there. Not a perfect one, but one I have

21 experience with. So that's all I have to say

22 about that.
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1 CHAIRPERSON FLAMM: Any other

2 board comments? If not we can begin the

3 voting on the petition to add nonanoic acid

4 CAS-112050 to 205.603 as an insect repellant,

5 as an insecticide. And we'll begin voting

6 with Nick.

7 MR. MARAVELL: No.

8 MR. FELDMAN: No.

9 MS. SONNABEND: No.

10 MR. STONE: No, sir.

11 MS. FULWIDER: No.

12 MR. AUSTIN: No.

13 MS. FAVRE: No.

14 MS. BECK: No.

15 MR. FOSTER: Yes.

16 MR. DICKSON: No.

17 MS. RICHARDSON: No.

18 MR. WALKER: No.

19 MR. BONDERA: No.

20 CHAIRPERSON FLAMM: And the chair

21 votes no. Oh, I'm sorry. 

22 MS. TAYLOR: No.
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1 CHAIRPERSON FLAMM: I did it

2 again. Sorry. I owe you. Jennifer, you

3 voted no? And the chair votes no.

4 MS. TAYLOR: Thank you.

5 CHAIRPERSON FLAMM: The vote is 1

6 yes, 14 nos, the petition failed. I believe

7 that concludes the business for today and

8 remarkably we've finished a little bit early. 

9 Unless, Michelle, you have something to call

10 to my attention we'll be in recess until 8

11 o'clock tomorrow morning. Have a good

12 evening, everyone.

13 (Whereupon, the foregoing matter

14 went off the record at 4:34 p.m.)

15

16

17

18

19

20

21

22
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abandon 85:19

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abandonment

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ability 52:5 94:10

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60:2 62:22 63:4,9

75:22 76:19 93:3

187:10 272:8

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absence 239:4

257:21 258:1

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108:11 109:14

120:3 129:20

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absorbed 128:8

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abstract 154:14

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ACA 165:15

167:10,12 168:2

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academic 153:13

Academy 200:7

ACAs 170:16 171:5

171:12 172:11

accelerated 244:19

accept 259:9

acceptable 104:18

107:18

accepted 17:13

86:7 152:7 153:7

154:11 294:1

access 38:14 42:5

64:19 73:19 74:3

74:4 122:10 132:5

159:16,18,21

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25:3,5 30:22 31:5

36:10 70:1 117:10

120:11,17

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achieved 181:10

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211:20,22 212:4

212:10 214:7

215:17 241:20,22

268:3 292:1 294:5

294:9,11 300:16

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213:14 214:15

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added 43:7 44:11

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176:18 202:16

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153:7 154:18

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118:11 144:10

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264:10

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151:4 156:1

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69:8 175:19

184:20 186:16

190:4 202:22

207:19 215:1

238:1 242:9,17

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100:11,16 234:11

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199:1,2,3 201:7

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106:6,13 110:7,16

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209:12 211:5

220:3 226:6

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102:3 103:1 105:6

105:6,9 107:16

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198:4 202:14

204:17 205:10

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224:10 226:1

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all-stage 287:4

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269:13 292:12

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129:9 164:14

213:10 225:19

252:2,2 259:12

265:8 284:10

298:11 312:9

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224:16 225:4

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311:6 312:4,5,14

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amazing 20:22 21:6

47:10 277:20

ambivalent 227:5

amendment 216:20

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America 107:1

125:1

American 36:14

153:14 200:7

amino 3:14 107:20

197:22 216:10,15

216:16,21 217:15

218:2 219:7,12

220:12,18 221:13

221:17 225:22

227:3 289:4

290:10

ammonium 204:9

amorphous 88:16

amount 25:11

133:6 139:13

176:18 188:22

205:6 226:3

258:12 270:17

302:15 308:13

amounts 109:4

153:21 221:17

295:11

amplification

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AMS 1:1 34:9

analogous 91:22

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analyst 71:7 134:12

Andrew 155:6

and/or 147:18

177:16

animal 8:6 127:3

127:15 128:7

130:21 137:6,10

137:12 138:3

152:16 153:9

154:19 247:3

255:10 299:8,9,11

299:13,20 303:20

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127:1 128:15

130:2 131:22

133:5,5,12,20

137:15 153:18

220:14 265:7

286:18 289:13

290:3 292:9

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119:20,21 121:13

121:13 291:20

300:6

Annie 300:9

annihilate 118:4

anniversary 20:17

50:16 68:2,12

106:18

annotation 110:8

110:18 136:22

150:12 185:2,7

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announced 85:16

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annuals 189:19

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answer 16:12 62:22

69:19 94:5 131:3

131:4 132:9

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195:3 272:1,4

289:16

answered 152:4

answers 123:6

240:13 296:14

antibiotics 90:17

101:14 105:6,17

139:3 163:19

anybody 15:17

21:3 49:18 74:14

133:8 288:12

anybody's 283:21

anymore 20:10

anyway 14:11 18:8

190:16,21 224:4

253:13

APHIS 46:22 49:4

231:13 235:14

236:13 239:22

241:10

apiculture 267:12

273:2

apologize 18:2 20:3

108:9

apparent 145:20

202:4 222:6

apparently 179:1

appeal 80:11

appealing 48:12

appeals 23:2

appear 212:21

appearing 111:12

applaud 52:1

Applause 13:10

48:9 69:15 106:12

apple 7:12

apples 8:12 212:12

applicable 45:4

46:12 83:12 111:1

149:15

application 293:7

296:17

applied 292:17

294:15 296:9

297:11 299:8,17

apply 274:1 295:1

295:9 297:20

applying 149:11

295:12 296:8

appointed 10:15

52:4

appreciate 53:7

82:3,17 96:5

98:11 122:19

134:7 143:19

145:7 149:10

160:8 169:7 175:4

241:6 265:4 290:4

290:5

appreciated 87:5

appreciates 111:22

appreciative 18:1

approach 143:11

148:7 149:14

177:22 229:16

230:7 303:12

appropriate 51:6

67:20 93:10

138:20 149:21

203:16 220:3

227:2 229:3

appropriated

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appropriateness

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Appropriations

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approval 17:10

80:16 89:11

149:16 155:13

approve 4:19 17:8

92:12 161:20

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approved 4:22

74:17 83:14 93:6

110:22 126:15

158:11 164:2

176:9 194:4

201:22 204:18

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approving 198:6

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approximately

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April 210:17

aquaculture 24:13

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ARA 161:15,18

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area 34:3 38:21

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112:22 120:8

157:6 167:22

186:3 189:19

areas 9:17 38:8

39:1 41:22 43:19

46:14 75:19 92:10

93:3 117:15 121:8

139:2 140:15

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arena 54:17

argument 142:1

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arguments 285:22

arises 159:8

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armed 130:10

arms 87:22

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arrangements

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Arsenault 2:10

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article 118:18

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ascertain 136:15

ascertained 100:12

ascorbyl 161:5

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asked 15:19 125:13

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asking 74:17 81:11

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attached 82:20

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attainable 38:18

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balance 76:3

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balances 163:17

Baltimore 248:15

banker 58:8

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bar 111:17

barrier 58:10

Barry 1:12,14 3:2

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210:11 242:18

base 165:3 301:22

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basic 29:3 62:7

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basically 63:15

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basis 27:12 28:10

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beans 99:11

bear 58:18 174:21

beautiful 11:18

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body 131:14

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Boston 248:14

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box 127:14

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breakdown 43:18

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breaking 186:6

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briefly 13:15 15:9

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bringing 84:11

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broad 107:8 154:6

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broader 85:1 243:7

broad-based

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brochure 65:2

broiler 260:21

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broilers 101:3,21

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Bronner's 111:13

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cab 267:20

cabinets 129:15

CAC 8:14

CACC 10:16 11:13

CACS 107:6

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CAFO 76:15

CAFOs 73:2 74:10

CAFO-type 137:8

cake 50:6

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75:8,13 76:11

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Canada 54:10

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Canadian 243:14

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cancer 149:3

candles 300:13

canola 302:2

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cap 252:13

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capacity 78:2

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cardiomyopathy

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career 14:16 47:11

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Carmela 1:15 9:3

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Carol 151:6 155:15

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carrageenan 80:8,9

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carrageenan's

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carton 246:22

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case 6:7 32:16

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Castel 70:20 71:4,5

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catalogue 55:6

catch 313:19

categories 280:2

category 33:4

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cats 219:22 280:8

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288:22 289:5

cattle 73:3,14 130:9

133:2 292:18

293:10 295:14

296:2,8 308:14

cause 48:6

caused 85:18

100:22

causes 152:5,15,19

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causing 197:22

caution 268:5

274:11

CCOF 106:15

109:1

CDC 254:8 293:13

cease 30:1

celebrate 20:13

52:8 53:18

celebrating 47:4

68:11 106:18

celebration 49:22

cell 5:5,8 128:11

256:6

cells 154:21 261:5

Census 60:13

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Center 134:12

153:4,21

centered 262:22

central 189:5

certain 46:9 177:7

205:10 261:6

301:17,17

certainly 26:12

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225:3,9 238:17

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106:15,22 108:14

108:14 138:10

174:3 181:10

183:1,8,10,14

192:16 194:10

243:22 244:17

274:21

certified 7:12,19,21

11:22 22:17 28:14

29:12,15 32:22

35:17 38:17 42:8

52:14 54:2 56:9

59:14,15 60:13

77:8 81:9 99:7

107:1 111:18,20

114:13 122:1

132:16 137:18

150:2 156:9 168:5

181:11 188:10

192:1,8 199:18

200:22 220:21

246:15 248:4

262:17 266:5

269:21 270:21

271:20 272:8

280:22 281:4

282:5,15

certifier 33:2 110:1

110:10,14 129:21

138:5 165:1 239:6

259:9

certifiers 7:15

25:18 29:20 30:18

31:3,10,11 33:17

34:20 35:2,19

38:10 102:7,12

110:12 120:13

138:18 166:2,17

166:21 167:15,20

168:7 169:19

171:19 234:16

269:2 275:11

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chair 7:3 8:14 9:12

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chairman 71:5

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17:12 69:2,9,21

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139:6 140:19

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151:1 155:14,18

155:22 159:11

160:3,9 164:16,20

168:10,22 169:4

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179:3 180:14,19

184:18 186:16

187:12 189:6

190:3 191:4,7

195:6 198:22

201:6 202:21

203:20 204:2

207:13,17 208:20

210:1,5,9 305:1,4

305:8,13,19 306:1

306:8 307:8,15,19

310:7 311:22

314:1,20 315:1,5

challenge 27:17

47:2 141:7 253:2

challenges 49:20

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17:20 18:1 21:14

28:6 47:5 48:17

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69:3,3,10 70:19

71:5 75:6,6,8,9

79:1 81:20 87:13

246:11

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34:3,7 38:14 42:1

42:5 60:3 74:7

77:5 114:8 122:17

133:11 199:10

204:16 219:5

221:9 222:10

287:2 297:8

marketability

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marketable 200:11

marketed 181:18

196:16 198:18

199:17,18 200:3

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marketers 262:21

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161:14,20 166:10

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135:9 143:5 147:2

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146:21 151:4,5

156:1 160:11,13

164:21,22 174:10

180:20,22 191:8

191:10 195:8

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35:16 36:5,14,20

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62:11 68:3 71:12

80:2 86:22 95:22

108:1 148:6,20

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227:11,16 230:3

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73:11,12 74:3

79:16 80:15,21

83:1,8,10,13 85:6

86:1 88:7 98:22

102:18 108:2

115:8 116:21

120:15 122:6

130:19 136:7

142:20 144:11

147:18 154:22

166:1,6,19,20

174:16 175:11,22

178:5 180:4,8

185:7 231:17

233:21 234:2,7,22

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32:9,12 34:6

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66:13 111:17

125:21 130:10

140:1 141:22

143:4 150:18

160:17 224:14

235:7 237:1

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occurring 163:8

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Office 18:17 36:19

37:15 56:19

officer 80:14

offices 62:16 65:3

officials 220:8

OFPA 42:15,19

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148:7 149:12

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oh 75:7 188:3 271:9

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OIG 34:17 37:3,8

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oils 111:19 161:22

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oily 295:3

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28:3 29:11 32:5

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55:21 82:10 105:5

168:21 174:14

179:6 192:6 201:5

216:9 241:13,14

242:8,19 247:8

256:17 261:21

262:2 270:20

272:18 274:7

282:8 286:4

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old 118:19 166:21

289:14 299:6

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Oleochemicals

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102:19 103:16

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OMRI-listed

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onboard 15:4

once 120:17 180:12

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ones 16:18 27:12

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269:17,18 282:4

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one-hundredth

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one-tenth 102:3

one-third 32:22

ongoing 230:18

on-deck 70:21

opaque 135:1

open 3:9 110:4

190:1 241:9

opened 32:5 127:5

opening 54:9

211:14 217:8

openly 182:17

operate 8:2 18:15

18:19 22:16 73:21

operated 79:20

181:6,7

operation 8:3,10

190:12 246:20

247:2

operational 108:20

124:13

operations 22:18

25:15 26:7 28:15

29:13,15,17 31:10

32:20 33:18 34:14

35:18 42:8 54:2

105:4 107:2 168:6

243:11 244:5

262:5

operator 117:22

245:14

operators 116:16

117:18 118:10

opinion 144:5

148:6,17 155:5

159:16 177:21

179:19 193:1

270:9 271:18

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197:7 201:17

202:19 205:1

206:3,3,6,17

209:3,5,8,21

218:20 220:1

229:21 230:12

232:9,10 235:3,9

236:13 237:5

240:12 241:18

242:3,8,9 247:4

247:18 250:8

252:4,6,7,14

254:4 273:1,5

274:16 278:8,12

279:13 284:22

286:14 287:8

289:14 292:4

295:17 296:6

297:15 299:12,20

299:21 302:8

304:17 305:2

306:3,12

we've 4:16 15:19

16:18,19 18:5,9

22:2 23:11,20

24:5,19 25:1,5,10

25:14,18 26:19

28:4 29:12,15

30:5 31:8,11 32:5

32:7 33:8,12,16

34:5,15 35:3 36:7

37:5,19 39:6,7,12

51:17 52:22 54:8

54:16,19 55:7

58:6,9 63:3 74:20

75:22 82:18 83:5

103:14,19 123:2

129:12 169:5

181:7 189:16

191:12 205:6

206:12 231:8,15

243:12 244:21

249:16 281:8,8,9

299:15 303:18

311:2 312:11

315:8

whatnot 79:7

whatsoever 114:10

wheat 100:4

whipped 285:8

wholeheartedly

188:15

wholesale 74:21

77:11 183:13

193:7 243:12

wholesome 164:9

wholly 43:2

WIC 163:3

wide 21:17 80:2

188:16 213:9

265:1

widely 149:14

267:17

wider 60:14

wife 7:18 125:11

181:1

wife's 206:10

wild 22:10 47:14

115:21 119:19

138:17

wildlife 116:19,20

117:9 118:4

136:20

wildly 76:13

willful 245:19

William 286:10

291:18

willing 69:19,22

wind 297:22

window 142:20

143:15

wine 8:13 119:14

wineries 119:14

wing 181:5

winter 128:17

189:19,22

Wisconsin 7:22

131:6 246:15

wish 69:4 178:17

265:7 305:11

wishes 4:21 179:22

withdraw 183:10

withdrawn 217:14

withhold 129:1,2

withholding 126:19

127:3

witness 25:2 218:7

Wolf 146:21

woman's 148:22

women 77:1 149:2

wonder 95:22

144:9 198:3

wonderful 50:6

69:12

wondering 139:16

185:5 187:21

189:8 205:1 214:2

woodlands 116:19

116:20 117:9

119:13,15

word 28:7 55:1

156:16

words 92:1 94:16

293:1

work 13:8 23:5

24:8 29:13 33:22

37:6,11 38:4

41:17 47:22 49:3

51:11,15,16,21

54:8,11,16 55:14

56:3 57:16,19

60:8 71:8,22

82:16 87:19 88:12

89:5,17 98:5

106:14 115:10

119:19,22 120:1,2

120:5 122:19

123:9 124:10

131:22 133:16

143:19 147:8

165:12 166:14,22

170:10 171:22

173:2,16 174:5

175:11,22 186:1,6

186:10 206:8

212:8 222:18

226:3 231:12

235:2 240:12

241:12 248:12,16

253:4,22 265:1

273:5,8 286:8

289:13,15 290:4

296:15 301:11,12

301:15

workable 83:17

237:5 265:11

worked 14:15

39:12,14 48:3
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50:10 62:12

160:17 167:10

184:9 219:15

223:5 243:12

working 3:17 7:7

21:12 24:10,11,14

24:16 26:3 31:16

34:8 36:4,14

40:13,22 41:20

45:15 46:20 50:2

56:21 57:3,5 62:1

62:8 72:17 82:11

83:16 102:9

147:11,19 209:21

209:22 230:22

231:4,7 232:1

235:9 236:13

237:6 238:18

240:22 261:4

267:13 268:1

269:2,4 273:1,2,5

274:16 300:21

304:3 308:14

works 48:20 223:9

301:13

world 132:4 194:15

198:3 221:16

245:5 246:16

269:15

worldwide 22:17

293:21

worm 129:16

worms 127:6

137:17 270:3

worse 74:18 230:10

worth 109:10 225:3

239:16

wouldn't 186:7

188:1 189:22

190:10 192:17

200:3,13 201:3

212:16 222:15

309:2,3,18 312:6

wounds 155:3

wrap 68:1

writing 145:14

written 3:12 4:17

67:9 80:13 87:7

91:20 107:9 139:4

139:9 147:4

169:20 170:6

172:12 233:11,15

303:18

wrong 78:20 178:4

194:14

wrote 95:15 206:4

288:4

Y

year 5:16 6:6,7 7:1

7:17 9:11 11:11

11:15 21:7,7 23:7

24:12,22 25:6

27:3,3 32:7,10,14

33:9,12 34:17

36:13 40:3 42:12

61:8 106:19 111:2

124:17 129:19

133:21 175:21

176:22 185:16

189:5 190:7,10,16

191:2 193:8 206:5

243:18 244:9

248:19 250:7

273:7

years 20:13,16,19

24:21 39:11 47:5

48:19 49:14 50:5

51:4 53:1,18 54:3

57:13 72:21 90:3

99:11 112:1,8

118:17 119:7

123:8 126:16

127:9 129:14

130:18 132:20

140:11 141:15

142:19 151:8

160:15,17 163:4

177:18 178:13

184:7,9,12 189:10

189:15 190:2,8,13

193:12 196:13

225:12 245:1,19

270:1 273:22

274:4,9 277:22

285:7 286:19

289:14 304:2

312:12

year's 26:18

yeast 271:8

yellow 6:1

yesterday 96:9

125:12 228:22

229:8 230:17

yield 181:22

York 74:18 206:5

young 47:13 101:4

Z

Zea 1:21 7:9 21:5

139:7 142:6

187:12 310:8

zero 126:18 140:11

162:12

Zirkle 8:9

$

$10 206:7

$100 54:19 57:11

$100,000 193:7

$120,000 33:17

$21 58:19

$210 277:16

$240 277:17

$30 90:9

$5,000 60:17

$60 59:4

$7.5 246:7

0

05 219:14

08 219:16

095 113:12 114:21

1

1 6:1,2 55:2 74:1

76:17 102:2,3,5

169:9 315:5

1,000 258:6

1,200 133:6

1,800-person

181:18

1:06 169:12

10 20:13,15 23:8,10

47:4 49:14 52:22

53:18 162:14

10th 14:4 68:2,12

10,000 192:21

258:3 259:5

10-year 49:11 52:9

100 71:15 127:9

128:1 133:5

177:18 188:11

223:22 262:10

101 64:11

11 1:11 100:13

11:33 169:11

112050 212:4

305:18

12 86:15 140:2,3

261:15 295:22

120 27:14

13 180:5 216:16

219:11

14 37:1 245:19

261:12 315:6

15 1:8 27:8 102:5

176:1 241:15

17 3:4

17011 36:12

175 181:15

18 140:4,10 142:7

18-month 142:18

1860 300:12

19,089 254:9

1965 302:12

1973 106:17

1979 286:14

1983 181:7

1986 181:10 192:1

1988 26:19

1990 71:19

1992 20:19

1997 214:6

1998 206:13

1999 304:4

2

2 24:21 39:11 42:1

48:18 74:3,14

101:20 102:16

140:11 142:19

184:6 189:10,15

190:2,8,13 196:13

224:15 247:19

258:8,21 295:8

296:17 312:11

2,290 254:14

2,300 107:1

2-pound 264:5

2-year 142:21

143:1,15

2:27 242:6

2:45 241:16 242:4

2:56 242:7

20 3:6 20:19 127:15

183:11

20-year 20:16

200 39:3 125:22

200,000 127:22

2000 162:13

2002 20:15 277:9

2004 284:5 291:5

2005 292:11

2006 211:4

2008 56:14 58:22

60:13 278:8

279:16

2009 54:3 56:11

85:20 109:20

162:15 183:15

201 64:11

2010 33:9 36:21

56:17 112:17

152:13 174:18

234:6 250:20

254:9

2011 26:18 32:7,10

33:11 36:7 161:21

174:17 181:12,13

210:17

2012 1:8 24:3 26:16

27:21 30:19 39:1

39:2,21 73:4

99:12 183:7

216:19
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2013 39:20,20 40:1

41:22 264:14

268:1

2015 54:3 56:11

204 33:12

205 171:11 232:8

233:2

205.105(e) 233:6

205.238(a) 264:8

205.600 233:21

234:9

205.603 107:22

210:19 212:4

216:22 268:3

307:13 314:4

206 312:5,7

206(a)(b)(c) 312:18

210 3:12,14

216 3:14

22 313:20

223 3:16

230 3:18

238(a)(6) 232:13

242 3:19

25 54:1 56:10

181:16 259:7

25(b) 147:15

26 151:8

263 33:18

269 33:10

279 32:6,7

29 193:12 210:17

254:14

3

3 101:5,21 102:16

112:1 119:7

225:11 295:8

296:17

3,000 253:5

30 25:16 27:8

160:15 179:5

203:9 216:19

246:1 258:11

277:17 296:1

30,000 22:17

30,000-foot 229:20

305 3:22 113:9

33 107:2

333 214:6

337 294:6

339 294:6

34 289:14

35 249:2

365 248:19

385,000 195:12

39 30:21

4

4 3:2 5:22 11:15

57:12 101:19

112:7 127:8

129:14 131:11

132:19

4th 53:5

4,247 254:10

4:04 304:21

4:15 304:19

4:20 304:22

4:34 315:14

40th 106:18

40-45 189:4

400 246:15

42 254:14

43 74:8 254:12

45 258:21

49 3:8

5

5 34:13 50:5 51:4

74:1 90:3 100:13

101:18 148:12,18

179:21 184:9,12

189:3 203:10

247:18 274:9

291:8

5-year 51:5

50 25:5 30:18

101:22 103:21

128:1 190:18

246:13 258:21

500 258:4

54 32:6

6

6 101:20 126:15

184:5,6 202:19

296:1

6-hour 125:12

6-month 61:10

6-7 261:11

60 74:18 182:2

259:1

603(a)(4) 232:21

65 8:4

68 254:10,11

262:16

7

7 171:11 248:19

262:14

7,000-member

156:6

70 3:9

72 128:7

75 259:5,7

8

8 262:14 277:22

315:10

8,256 254:12

8:00 1:10

8:03 4:2

80 4:15 27:15 33:12

127:19,20 282:20

8910 292:17,19

293:7,19 295:19

299:7 303:4,8

304:4

9

9 167:13 196:12

261:15

9,000 195:12

9,000-cow 72:19

9:20 70:12

9:45 70:8

9:48 70:13

90 22:15 27:14

110:9 140:12

142:20 293:9

304:2

90-day 127:2 129:1

129:2

95 148:15 291:6
NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 

1323 RHODE ISLAND AVE., N.W. 

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 

C E R T I F I C A T E

This is to certify that the foregoing transcript 

In the matter of: 

Before: 

Date: 

Place: 

was duly recorded and accurately transcribed under 

my direction; further, that said transcript is a 

true and accurate record of the proceedings. 

 

 ----------------------- Court Reporter 

363

Meeting of the National

Organic Standards Board

USDA

10-15-12

Providence, Rhode Island
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 UNITED STATES DEPARTMENT OF AGRICULTURE

 AGRICULTURE MARKETING SERVICE (AMS)

 NATIONAL ORGANIC PROGRAM (NOP)

 + + + + +

 MEETING OF THE NATIONAL ORGANIC

 STANDARDS BOARD (NOSB)

 + + + + +

 TUESDAY

 OCTOBER 16, 2012

 + + + + +

 The National Organic Standards Board

convened at 8:00 a.m. at the Biltmore Hotel,

11 Dorrance Street, Providence, Rhode Island,

Barry Flamm, Chairperson, presiding.

MEMBERS PRESENT

BARRY FLAMM, Chairperson

HAROLD AUSTIN

CARMELA BECK

COLEHOUR BONDERA

JOSEPH DICKSON

TRACY FAVRE

JAY FELDMAN

JOHN FOSTER

WENDY FULWIDER

NICHOLAS MARAVELL

JEAN RICHARDSON

ZEA SONNABEND

MAC STONE

JENNIFER TAYLOR

CALVIN WALKER
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STAFF PRESENT

MILES McEVOY, Deputy Administrator, National 

 Organic Program

MICHELLE ARSENAULT, Advisory Board Specialist

MELISSA BAILEY, Director, Standards Division,

 National Organic Program

LISA BRINES, Standards Division, National 

 Organic Program

EMILY BROWN-ROSEN, Agricultural Marketing 

 Specialist

JENNIFER TUCKER, Associate Deputy 

 Administrator 
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 A-G-E-N-D-A

GMO Ad Hoc Subcommittee

 Subcommittee Proposal and Summary of

 Written Comments. . . . . . . . . . . . .4

 Public Comment. . . . . . . . . . . . . 21

Crops Subcommittee

 Subcommittee Proposal and Summary of

 Written Comments. . . . . . . . . . . . 65

 Proposals

 Ferric Phosphate. . . . . . . . . . . . 66

 Oxidized Lignite. . . . . . . . . . . . 76

 Propylene Glycol Monolaurate (PGML) . . 82

 Other ("Inert") Ingredients in Pesticide

 Formulations on the National List . . . 86

 Rotenone. . . . . . . . . . . . . . . .102

 Sulfuric Acid . . . . . . . . . . . . .117

 Biodegradable Mulch Film from

 Bioplastics . . . . . . . . . . . . . .122

 Update from the Tree Fruit Working

 Group: David Granatstein. . . . . . . .148

 Presentations

 Consumers Union:

 Dr. Urvashi Rangan. . . . . . . . . . .175

 Organic Seed Alliance:

 Kiki Hubbard. . . . . . . . . . . . . .196

 Public Comment. . . . . . . . . . . . .221

 Board Votes . . . . . . . . . . . . . .354

Materials Subcommittee

 Subcommittee Proposal and Summary of

 Written Comments. . . . . . . . . . . .378

 Board Votes . . . . . . . . . . . . . .394
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1 P-R-O-C-E-E-D-I-N-G-S

2 8:04 a.m.

3 CHAIRPERSON FLAMM: The meeting

4 will please come to order. This morning we'll

5 begin with a session led by Zea, the Chair of

6 the GMO Ad Hoc Subcommittee. And I'll turn

7 the gavel over to her right now to conduct her

8 session.

9 MS. SONNABEND: Thank you, Barry,

10 and good morning everyone. 

11 Michelle will put up the posted

12 recommendation. And I heard from some of you

13 in the audience last night that it was very

14 hard to hear in the back of the room so if

15 perhaps the sound people can be conscious of

16 that. And I'll try and speak up to the extent

17 possible.

18 Okay. As we talked about at the

19 last NOSB meeting in Albuquerque with the

20 mission behind forming this new Ad Hoc GMO

21 Subcommittee we wanted to keep the issues

22 around GMOs of which there are many because
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1 you keep hearing them coming up all the time

2 in front of the board and in front of the

3 public to be able to call attention to the

4 fact that organic does not want to have any

5 GMOs and we consider the effects of the GMO

6 world on our organic industry to be

7 essentially chemical trespass. 

8 And we need to take whatever steps

9 we can to keep them out. And one of the key

10 steps to do this will be to keep talking about

11 it, keep working towards clearer and clearer

12 definitions, places to draw the line and

13 associated issues around GMO presence in our

14 organic community.

15 So, we started work, and this was

16 at the request of some of the members of AC21

17 that we started to work on seed purity. We

18 wanted to find out by putting out a discussion

19 document from the organic community what was

20 going on out there in the GMO seed world -- 

21 or I shouldn't say GMO seed world -- in the

22 seed world for organic production that may or
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1 may not be contaminated with GMOs. And that

2 includes both organically grown seed and

3 conventionally grown seed that is trying to be

4 kept -- have less GMOs.

5 I'm not going to read the whole

6 document because those of you interested in it

7 will have read it. But I'm going to summarize

8 the public comment and then along the way have

9 a few thoughts of where we're going to go from

10 here. And then I'm sure we're going to hear

11 some more public comment and we'll take that

12 under advisement as we do our work.

13 So we received 66 individual

14 comments. Eight-five of them, which I know

15 sounds weird, but it was actually in 7

16 letters, but one of them represented 79

17 people, copied the language from Beyond

18 Pesticides which we'll summarize in a moment. 

19 Eight people put in comments on GMO subjects

20 not related to seed purity such as labeling,

21 keeping GMO citrus trees out and other things

22 that are important perhaps in the future but
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1 are not the subject of this paper.

2 And then we got about 26

3 substantive comments. And then while some of

4 them were duplicative, like we support someone

5 else's comments, but I consider them

6 substantive if the person or group took time

7 to write a distinct letter of their own that

8 raised their own issues.

9 I'm going to only -- with 26

10 comments which really were all over the place

11 and we got some really good feedback and some

12 things we hadn't thought of concerns, but I'm

13 not going to be able to summarize every single

14 comment on every single question so I

15 apologize if I leave yours out but I tried to

16 capture all of the unique ideas and

17 suggestions that were present.

18 Okay. So, in the -- before we get

19 to the actual questions we posed we of course

20 had a number of people write in overarching

21 comments. And Michelle, if you can scroll up

22 just a bit.
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1 Okay, so Blue River Hybrids which

2 is one of the more critical of our proposals

3 said, "Seed purity standard must consider

4 whether organic farmers' choice of seeds would

5 be limited to those of poorer genetics or

6 variety of genetics. It's disappointing that

7 the many positive reasons for using organic

8 seed are not considered."

9 We of course realize that we

10 didn't put in the many benefits of using

11 organic seed. That was not the focus of the

12 paper and we were trying to keep it short. So

13 we acknowledge the comment.

14 The ACOA along with the PCO: "The

15 discussion of seed purity standards need to

16 occur at all levels. Certification agency

17 staff, producers, handlers, buyers, marketing,

18 co-ops. Clarification on education on terms

19 in the field is needed." And although that

20 certainly goes with question 7 also but I

21 thought that was important to bring out.

22 ACOA recommends we take a
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1 leadership role in establishing broadly

2 applicable USDA regulations. That is what we

3 are trying to do, we, the NOSB, and hopefully

4 through us the NOP.

5 Organic Seed Alliance believes

6 that the next step for the NOSB is to apply

7 more pressure on the Secretary to fulfill his

8 obligation to support the success of organic

9 ag. The NOSB can provide specific

10 recommendations that speak to lack of policies

11 and practices that eradicate GE material and

12 seed. And we need access to good data. We

13 definitely agree.

14 Organic Valley/CROPP Cooperative

15 feels that the policy memo from the NOP fails

16 to address the issue of adventitious presence. 

17 And they believe this testing standard

18 represents -- while it represents a departure

19 from the process standard foundation and

20 carries some risks they think that market

21 expectations and seed industry practice demand

22 and enable such a shift. OTA cites the
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1 benefits to seed growers and farmers of having

2 such a program.

3 Okay, so question 1, is there a

4 need to establish a seed purity standard or

5 protocol, and please explain. So, the 85

6 commenters plus Beyond Pesticides say roughly

7 we endorse the development of a seed purity

8 protocol only in combination with a

9 comprehensive plan to prevent GE contamination

10 along with a rigorous enforcement strategy. 

11 This enforcement strategy should be

12 spearheaded by the USDA. 

13 I would have to say in general our

14 subcommittee agrees with this. We talked

15 about this quite a bit on our work plan

16 although not -- it won't be immediate work

17 plan but we do have planning to prevent GE

18 contamination as one of the things we will be

19 working on.

20 OSGATA would like to encourage the

21 USDA to establish seed purity standard and

22 protocols to implement and ensure that organic
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1 and conventional planted seed as well as

2 parental seed lines for breeding and

3 foundation stock seed maintain genetic

4 integrity.

5 ASTA does not believe there is a

6 need to establish an NOP-required seed purity

7 standard. And they feel it's an additional

8 burden for organic farmers and additional

9 costs would be incurred by organic farmers and

10 then passed onto the consumer.

11 CCOF is absolutely in support of

12 preventing GMO use in organic production and

13 would consider a seed purity standard but are

14 very concerned about the same thing as ASTA

15 which is additional cost to organic growers. 

16 They would rather see a process-based

17 certification that looks to risk analysis and

18 mitigation rather than moving towards product19 based certification dependent on testing.

20 They also point out that the

21 regulations 205.670 requires the certifier to

22 bear the cost of all testing of products and
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1 inputs that we would require as part of

2 certification. And that having the certifiers

3 pay for any testing of seed would become very

4 burdensome very fast. And so we'll have to

5 work on that consideration in our future work.

6 Blue River would not encourage

7 seed purity standard. It will create more

8 problems than it solves. OGC echoes OSA so

9 we'll get to that. Organic Valley/CROPP

10 recommends seed purity standard of none found

11 in the 3,000-seed sample for seed in the

12 organic production. The seed industry has

13 made it clear that they are technically

14 capable and willing to provide the organic

15 community with a continuous supply of elite

16 genetics that meet such a standard and they

17 can do so at an affordable price.

18 Oregon Tilth: the genetic purity

19 standard needs to be established by the USDA

20 to meet all seed -- to address all seed

21 organic heritage, convention and GMO. Any 

22 farmer purchasing seed deserves assurance it
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1 is pure. OTA believes setting a seed purity

2 standard can be consistent with process-based

3 standard when analytical limits are used to

4 verify that adequate measures are in place to

5 prevent contamination with excluded methods. 

6 Seed purity standard if properly established

7 would protect rather than burden organic

8 farmers.

9 Organic Seed Alliance believes too

10 soon to implement a universal genetic purity

11 standard for reasons described. They're

12 concerned about the impact such a standard

13 would have on organic seed availability which

14 is another risk to organic integrity. They're

15 concerned that adding another risk point such

16 as a standard would discourage further

17 investments in organic breeding and

18 production, thus diminishing choice in seed

19 and undermining progress.

20 They're also concerned that the

21 potential to unintentionally encourage the use

22 of non-organic seed and therefore further more
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1 the conventional seed industry which can

2 invest in meeting a genetic purity standard

3 where organic seed, it costs more to produce.

4 Okay, I'm not going to summarize

5 the answers to questions 2 and 3 which were

6 what's known about contamination and testing

7 and what testing methods are appropriate

8 because we didn't quite get the volume of

9 information we were hoping for. While we

10 thank those who did put in something it's kind

11 of all over the map and very difficult to

12 summarize. But the committee will look at it

13 in its future work.

14 Same with number 4 because that

15 was very specific to each person's business. 

16 We're not going to try and just say that for

17 everyone and we'll talk about it within the

18 committee. It's all in the public docket so

19 everyone can read the comments for themselves.

20 Is there a better suggestion for a

21 seed purity standard? And this was key to us

22 because we were just using one that we had
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1 heard was commonly used in the seed testing

2 world but not the only one. So we received a

3 few responses.

4 OSGATA's policy on genetic

5 engineering states, "Contamination of organic

6 seed constitutes irreparable harm to the

7 organic seed industry by undermining integrity

8 of organic seed. Any detectable level is

9 unacceptable. International experts in GE

10 detection recommend 10,000-seed sample size

11 for PCR which is one of the testing methods. 

12 A 10,000-seed sample takes full advantage of

13 statistical limit of detection. In other

14 words, we're concerned that depending on the

15 lot size in question 3,000 seeds is to small

16 to statistically assess the minimal signal to

17 be determined as meaningful measurement. 

18 And then they go on to suggest a

19 combination test method of qualitative and

20 quantitative PCR and give examples. We'll

21 have to look into the technical aspects and

22 feasibility of that suggestion.
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1 ASTA which is the American Seed

2 Trade Association, by the way, as OSGATA is

3 the Organic Seed Growers Trade Association. 

4 If there is for market reasons value in a

5 threshold then the AOSCA standards -- don't

6 ask me what this stands for but Kiki will tell

7 us later because I always forget what AOSCA

8 stands for. 

9 The AOSCA standard for certified

10 seed may be suggested standard to use as

11 guidance. They are a seed certifying agency,

12 AOSCA. In any case regarding testing the

13 scope and appropriateness of testing should be

14 based on the crop. Frequency of testing

15 should consist of new harvest seeds and seed

16 safes for planning. They talk about ISO

17 quality system. 

18 Organic Valley in response to the

19 question, they don't believe there's a better

20 type of seed-testing protocol. This standard

21 appears to strike the right balance between

22 rigor and feasibility. The standard will be
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1 based on non-detectable sample so the

2 discussion therefore revolves around sample

3 size. A standard that would allow for

4 detection of any transgenic material in the

5 sample would be unacceptable to us and that's

6 why we don't like the words "threshold" or

7 "tolerance" and avoid using the statistical

8 equivalent expressions of less than 0.1

9 percent with 95 percent confidence because

10 such terms and expressions falsely imply some

11 level of presence. 

12 The subcommittee has agreed with

13 us and that's why you don't find the words

14 "threshold" or "tolerance" anywhere in the

15 discussion document. Blue River says if

16 absolutely needed I would suggest a standard

17 of less than 1 percent. 

18 Organic Seed Alliance. The NOSB

19 should apply real pressure on the USDA to

20 establish a system for ongoing testing and

21 monitoring organic and GE. Non-GE community

22 needs a comprehensive data set for
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1 understanding the state of GE contamination.

2 Testing is necessary but not at

3 the total expense of the organic community. 

4 Testing should occur in the context of

5 comprehensive regulatory framework

6 administered by the USDA for GE crops. This

7 would include proven prevention measures in

8 the field, adequate compensation for organic

9 farmers, shared costs for testing and

10 prevention on the part of owners and users of

11 GE products, and routine monitoring of

12 contamination at the seed level.

13 I would say we agree with that but

14 getting the USDA to do their part outside of

15 the NOSB who is trying to do their part, but

16 the rest of the USDA, not so much as we know.

17 Question 6. We're not going to

18 summarize that question. We did not get very

19 much response to it.

20 Training guidance or resources. 

21 We did get some responses and I'm not going to

22 read them all out now but we got some good
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1 information from expected groups like the ACA,

2 OTA and Organic Valley about training and who

3 can help with it such as AOSCA and things like

4 that.

5 Question 8, what approach should

6 an organic seed producer use to safeguard

7 against GMO contamination from adjacent and

8 neighboring farms? And this is something that

9 we will be working on, as I mentioned, in our

10 future work plan about a prevention strategy

11 guidance.

12 And we got comments similar to

13 some of the above. We need a comprehensive

14 approach that includes not just seed purity

15 but identifies and addresses sources of

16 contamination all along the supply chain. And

17 then Blue River pointing out the problems,

18 that you can do everything right and still get

19 contaminated. We do recognize this and it's

20 very unfortunate. 

21 OSGATA seed growers and seed

22 companies supplying organic seed to the
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1 organic community should follow protocols by

2 which design intercept GE contaminants. And

3 they talk about their prevention strategy that

4 OSGATA will be publishing fairly soon, I

5 believe early next year.

6 So, I think we have a good

7 starting place. We were hoping for a little

8 bit more specific data on what gets tested and

9 how often and what sample sizes are used and

10 things like that. And clearly one of our

11 first missions is to try and inform ourselves

12 of some of that information. I don't want to

13 say we're going to initiate a survey because

14 that is problematic for the department, but

15 we're going to look into working with maybe

16 the Economic Research Service or some other

17 ways that we can find out more what's

18 happening in the organic community. 

19 We are going to be working towards

20 a recommendation. I'm not sure how fast this

21 work will take place. You will see it on our

22 work plan for the next meeting. But in light
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1 of the fact that we're not really in a

2 consensus mode about this and we could

3 certainly use a lot more stakeholder input

4 we'll see how fast we're getting there. But

5 I'd like to thank all the commenters and that

6 concludes my presentation.

7 Okay. We're now ready to start

8 the public comment on this but I don't know

9 who's up. Beth Unger.

10 MS. UNGER: Good morning. I'm

11 Beth Unger with CROPP Cooperative, a farmer12 owned cooperative marketing organic products

13 through Organic Valley and Organic Prairie

14 brands. 

15 I want to thank the Ad Hoc

16 Subcommittee for the work they did. I thought

17 this was an excellent start. And we are very

18 much behind you.

19 We believe that clean seed is the

20 first and most critical component of providing

21 consumers with the purity they expect from

22 certified organic products. In fact, without
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1 first establishing a non-detect standard for

2 the seed used in organic production and

3 gaining the seed industry's cooperation in

4 providing such clean seed it will continue to

5 be very difficult to figure out how to deal

6 with GMO contamination in crops and products

7 further down the supply chain.

8 Our commitment to clean seed is

9 reflected in our written organic seed policy

10 that contains a phase-in period for our

11 members to begin using tested clean organic

12 seed. To that end we have been and will

13 continue to work with the seed industry to

14 find a path for seed companies to provide

15 farmers with seed that meets the genetic

16 purity standard of none found in a 3,000-seed

17 sample.

18 We're convinced that such clean

19 tested seed can be technically accomplished by

20 the seed suppliers and will be made available

21 to the organic community if we continue

22 exploring practical options with them and work
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1 together to create an attractive market for

2 them.

3 Excuse me, I am not a reader for

4 comment, I'm always extemporaneous which

5 didn't work here. All right.

6 This is not a discussion of

7 process-based versus product-based standards. 

8 OFPA requires residue testing. GMO

9 contamination is a residue. Rather, this is

10 an opportunity to work with seed companies to

11 resolve rather straightforward technical and

12 marketing issues in order to provide us with

13 a wide variety of clean foundation seed.

14 Some seed companies in the

15 comments that you were talking about, Zea, say

16 they can't meet a genetic purity standard. 

17 Some don't know if they could and some believe

18 they can.

19 We believe that working together

20 we can make the standard happen. It is well

21 worth the conversations. The actions that we

22 take as an organic community can facilitate
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1 the process of accessing clean foundation

2 seed. 

3 As we go forward to further

4 discuss and refine the discussion document and

5 ultimately provide a solid proposal to the

6 National Organic Program that is a product of

7 cooperation among the organic community we

8 will protect and build foundation seeds and a

9 supply chain that ensures the future of

10 genetically pure seed. 

11 We believe that establishing a

12 non-detect standard for seed use in organic

13 production and securing cooperation of the

14 seed industry in providing us with a wide

15 selection of varieties that meet the standard

16 will not harm or hinder the development of a

17 robust organic seed supply chain, but will

18 open the door to significant progress and a

19 new round in the growth and development of the

20 organic industry.

21 This discussion document is a

22 wonderful start. Let's engage the USDA, the
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1 primary seed genetics companies, the companies

2 that grow and sell commercial seed and the

3 organic community to refine the proposal based

4 upon consensus by working with the supply

5 chain in a cooperative manner that will ensure

6 the integrity of the organic seed.

7 MS. SONNABEND: Thank you, Beth. 

8 Are there any questions from the board? I see

9 Carmela.

10 MS. BECK: Beth, I was just

11 wondering, how do you handle your growers that

12 save their own seeds?

13 MS. UNGER: I believe -- well

14 first of all, we would definitely support

15 saving seeds. That's a foundation of

16 agriculture. And there are ways to get that

17 tested. 

18 We for instance have established a

19 testing lab in-house where we can help with

20 the testing of seed. I think that that safe

21 seed is something that should be tested on

22 occasion to ensure there's no creeping
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1 contamination. There's ways to do it.

2 MR. FOSTER: Good morning, Beth. 

3 So this question won't be a surprise to the

4 board members. So, the -- do you foresee the

5 seed purity standard increasing, decreasing

6 the burden of testing on growers? No change? 

7 How is it going to impact them?

8 MS. UNGER: Well, I think in a

9 perfect environment, John, you'd want to see

10 the seed companies taking responsibility. And

11 I'm not talking just about organic seed

12 companies. Any seed company supplying seed to

13 the organic community would need to be a part

14 of this. It would be, you know, the best case

15 scenario here is to really increase the

16 foundational varieties for the organic seed

17 suppliers and start growing the organic seed

18 market more and more.

19 Did I answer your question

20 adequately?

21 MR. FOSTER: It actually answered

22 a question I didn't ask but thought of. I
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1 don't know how you did that but well done.

2 But you know, one of my things is

3 I don't want more pressure on -- undue

4 pressure put on growers for things that they

5 may or may not have control over. So as you

6 see these ideas rolling out I just, I want to

7 recognize that, you know, a lot of testing is

8 hard for a lot of growers, and sometimes it's

9 financially untenable. 

10 So, do you see like the burden of

11 testing, do you see that squarely on the

12 manufacturers, or squarely on kind of an MRO,

13 like an OMRI, for example, for seed? Or do

14 you think that could fall to the growers and

15 do you feel like that would be a problem?

16 MS. UNGER: I feel that the

17 testing goes back to the seed companies, the

18 seed growers. And that's where engaging all

19 of the seed companies in this conversation is

20 critical. We've been doing that, you know,

21 been working on it. We'll continue to work on

22 it and certainly would be happy to work with
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1 the committee in facilitating engagement.

2 MR. STONE: So Beth if we have a -

3 - anytime we put numbers in regulation it

4 seems to bite us at some point. So how do we

5 have a process-based without strict numbers? 

6 I'm kind of along the line of John's question

7 too of it seems like the innocent could get

8 hurt pretty easily. And I'm also concerned

9 that do we have enough clout with the seed

10 industry that they're not going to throw up

11 their hands and kind of say wait, wait, you

12 all are asking too much and I'm just going to

13 get out of that market.

14 MS. UNGER: Well, you know, in the

15 comment that you received there was really a

16 mixed bag of where the seed companies were at. 

17 And so it's really critical, Mac, that this is

18 an engagement of the seed suppliers.

19 We believe that this is doable. 

20 And it's a matter of everybody sitting at the

21 table and figuring out, you know, a win-win

22 position for everybody.
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1 MS. SONNABEND: Any more

2 questions? Thank you, Beth. Oh, sorry. 

3 Jennifer.

4 MS. TAYLOR: I have a question,

5 thank you. What role do you see, or do you

6 see a role for others within the seed system? 

7 The growers you're saying and the seed

8 producers as well as the transportation

9 system, other seed cleaners. Are there others

10 within this role?

11 MS. UNGER: There most likely is

12 and I think the conversation will bear that

13 out.

14 MS. SONNABEND: Anyone else? 

15 Okay, next Dag Falk. Please state into the

16 mike.

17 MR. FALK: Hello. I am Dag Falk,

18 organic program manager for Nature's Path

19 Foods.

20 Dear National Organic Standards

21 Board, Nature's Path is North America's

22 largest certified organic breakfast cereal
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1 producer and we want to keep organic standards

2 with a high level of integrity and to match

3 the expectations of the committed organic

4 consumer.

5 We recognize the standards also

6 have to be workable for producers and

7 production, and a balance needs to be found. 

8 Maintaining organic principles is the highest

9 importance and sometimes must override

10 production and market conveniences. Without

11 consumer confidence in the organic label there

12 is no organic market.

13 Regarding GMOs we are glad that

14 the NOSB sent a letter to Secretary of

15 Agriculture Tom Vilsack and we would like the

16 NOSB to take an even stronger stance. 

17 The organic industry is lagging

18 behind in its approach to protecting itself

19 from GMO contamination. This is likely

20 because GMOs were introduced after the early

21 organic standards were developed and because

22 GMO contamination cannot effectively be dealt
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1 with in the same manner as other prohibited

2 substances because GMOs are linked to living,

3 reproducing organisms.

4 It is time to update the organic

5 standards to deal with the exposure to GMO

6 contamination risk which is growing at an

7 unprecedented rate. 

8 Organic standards are built around

9 dealing with issues at the core, not applying

10 Band-Aids after the fact. So it makes perfect

11 sense that a key area of focus should be

12 developing a seed base for organic agriculture

13 that is as free as possible from GMO

14 contamination.

15 Our experience when using high

16 volumes of GMO risk ingredients, corn and soy,

17 that's what we deal with, is that the organic

18 supply chain is contaminated with GMO,

19 sometimes more than conventional ingredients

20 that are expected to be non-GMO. This is a

21 sad reality and our response has been to

22 enroll our products in the Non-GMO Project
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1 verification program which addresses the

2 shortcomings in the organic standards.

3 Organic as a system has the

4 pitfall of not discovering existing

5 contamination and actually discourages testing

6 from being undertaken by organic farmers and

7 manufacturers. That's the reason to believe

8 that if no one knows there is contamination

9 then no one cares. The problem is someone

10 does care and concerned consumers will begin

11 to demand organic cleanup more than it is

12 today. 

13 Without utilizing the tools of

14 testing for presence of GMO on an ongoing and

15 consistent basis there is no way to improve

16 the situation. Testing must be embraced by

17 the NOP rule as a tool to apply the practice

18 of avoiding GMO contamination for soy, corn,

19 cotton, canola and sugar beet, specifically

20 for seed and finished ingredients. And of

21 course you have to test precursors to some

22 ingredients like oils because they can't be
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1 tested.

2 I want to make a couple of points

3 on the reason -- in order to make testing

4 meaningful a threshold needs to be established

5 and that's for three reasons. The first

6 reason, provide a safe level for farmers under

7 which they will not encounter the business

8 risk of rejection of their product. 

9 Two, provide a level which

10 consumers can understand and can be

11 achievable, yet necessary because we live in

12 a polluted world and that they can accept. 

13 And third and the most important

14 is to provide a tool to force the conversation

15 about cost and liability for contamination to

16 happen in arenas outside of organic. The

17 industries and farmers that are at the source

18 -- are the source of GE contamination of

19 organic farmers and products must be forced to

20 take responsibility. 

21 We have seen for too long that

22 politely asking for this is not working. 
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1 Having a threshold is an essential and key

2 component that must be in place in order to

3 demonstrate the cost -- that cost, harm and

4 hardship has occurred.

5 There's more detailed answers in

6 my handout that I just passed around. There's

7 two other areas that I want to make brief

8 comments on outside of GE that I guess I don't

9 get to do. Thank you. 

10 MS. SONNABEND: Thank you, Dag. 

11 Are there any questions? Well I have one if

12 I don't see any other board members. How do

13 you suggest we as a board who is not the rest

14 of the USDA so we can't really deal with the

15 topics we need the rest of the USDA to deal

16 with, but how do you suggest we collect enough

17 information on the topics that we do need

18 information to proceed? Such as how

19 frequently to test how many seeds in a sample,

20 all of those types of details.

21 MR. FALK: I think that there is

22 quite a bit of experience out there in the
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1 world internationally and also with the Non2 GMO Project and so because that's been ongoing

3 for awhile there's been a lot of experience in

4 dealing with these very complex issues. And

5 so I think that the information is there, we

6 just have to dive into it.

7 The other thing I think is that if

8 we don't take the first step and actually

9 require ourselves to do some looking, to do

10 some testing, to do some investigation by

11 setting in place some rule we won't start the

12 process of actually gathering information. We

13 need to start gathering it and we cannot

14 gather it unless we say we need to set a

15 threshold, we need to understand that we can't

16 actually get there without taking the first

17 step.

18 MS. SONNABEND: Thank you. John?

19 MR. FOSTER: So that made me

20 wonder, I don't follow that. Why is the

21 establishment of a number a necessary

22 precursor to gathering information? I've
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1 never let a number establishment get in the

2 way of information-gathering before. So help

3 me understand that.

4 MR. FALK: You mean a threshold

5 number?

6 MR. FOSTER: Right, threshold. 

7 Right. Maybe I misheard you.

8 MR. FALK: Well, if we -- you

9 know, this is what we're doing. We're saying

10 we're going to look for something but we're

11 not really looking. 

12 We have a practice standard today

13 and yet contamination levels in organic are

14 increasing. And I feel like that's because we

15 are not establishing the level because it's

16 not safe to look. Because the number is

17 infinite or, anybody's imagination is where

18 the number is. So everybody is scared to do

19 any testing. 

20 Everybody is scared to know or

21 talk about what their contamination levels

22 might be because there's no safe level. 
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1 There's no level which by if I tell you you're

2 going to think I'm okay. So we have to have

3 a level where farmers are safe. Otherwise

4 they're never, ever going to engage with us on

5 this very difficult issue.

6 MS. SONNABEND: Nick.

7 MR. MARAVELL: Yes, a follow-up on

8 John's questions. Would a number be identical

9 for all crops? How long would a number stay

10 constant?

11 MR. FALK: I think that a number

12 should start as high as we can afford to make

13 it as easy as possible as an entry point. 

14 Because once we have established a number

15 we're going to start gathering data and then

16 hopefully we'd be able to tighten the number

17 so that we're cleaning up the issue. 

18 So, yes. Does that answer your

19 question?

20 MR. MARAVELL: Not exactly, but

21 what you said is make the number as high as

22 possible in order to provide entry into this
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1 process. Is that sort of like a "let's take

2 a look" number, or is that a number that would

3 disqualify a product from being in the organic

4 status?

5 MR. FALK: That's a question I

6 think the whole industry has to struggle with,

7 whether it's a pass/fail number or whether

8 it's an action threshold that means we take

9 certain actions based on it. 

10 You know, preferably -- like we're

11 very concerned about causing hardship for

12 farmers in particular and processors, and

13 that's not the objective here. We're trying

14 to save our own industry. We're not trying to

15 create more hardship. But at the same time we

16 lose our confidence from the consumers if we

17 just let this thing get out of hand. 

18 So we're sort of stuck between

19 these two places and we have to find the best

20 number possible to make it feasible at the

21 same time as we are aiming towards reducing

22 contamination. So we have to be preparing
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1 ourselves to ratchet it down as it becomes

2 feasible. But why set it so low that we can't

3 achieve it? That's the reason why we'll have

4 to look at that, setting that number very

5 carefully.

6 MS. SONNABEND: Thank you, Dag.

7 MR. FALK: Thank you.

8 MS. SONNABEND: The next, Jim

9 Asta.

10 MR. LANGER: Yes, this is Dave

11 Langer. I'm a research director at Dupont

12 Pioneer Hybrid Seed Company and I'm here today

13 representing the American Seed Trade

14 Association. And I want to thank the board

15 for the opportunity to comment.

16 On my first slide here I take the

17 opportunity to kind of take you over the flow

18 chart, the basic flow chart of the seed

19 industry. And we have several things. Zea

20 already mentioned the Association of Official

21 Seed Certification Agencies (AOSCA) a process22 based approach. We also have ETS here,
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1 Excellence Through Stewardship, by which we

2 identify protocol and procedures throughout

3 our industry.

4 And the first part there is a

5 module, is the lab research that we conduct. 

6 And then we have greenhouse and contained

7 facilities growth chambers. The third module

8 is field trials. That's where we do our plant

9 breeding, our characterization, trait

10 integration work.

11 And then the fourth module is seed

12 multiplication. This is where associations

13 like the Seed Certification Agency, their

14 process-based protocols are followed in that

15 area to ensure that we produce quality seed

16 that is used then to make commercial seed for

17 sales and distribution. And as this chart

18 shows, and we're doing this all for the farmer

19 customer to provide them seed.

20 Zea read many of these comments

21 earlier from ASTA. The one on coexistence,

22 the fact that is coexistence between different
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1 bodies is possible. We are an example of that

2 in the seed industry in our seed production. 

3 We deal with coexistence issues all the time.

4 We do take deference to the use of

5 the phrase "GMO contamination." It is

6 misleading for products that have been through

7 a thorough safety assessment. GE things have

8 gone through EPA, USDA, FDA assessment so they

9 are deemed safe.

10 What testing methods? You know,

11 the standard for seed purity and seed purity

12 labeling is dictated by the Federal Seed Act

13 and compliance with that lies within the

14 Federal Seed Act and that's what the seed

15 industry follows. 

16 There is a range of testing

17 available for testing GE. We, instead of

18 contamination we talk about it as being

19 adventitious presence, defined as unintended

20 low-level presence of GE material. 

21 What testing methods? One thing

22 you have to be aware of is you have to make
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1 sure you're using accredited labs. These

2 tests, the PCR tests that Zea mentioned

3 earlier, they are very sensitive tests. They

4 are prone to err based on that sensitivity. 

5 And there's types of error. 

6 There's sampling error. I don't care if it's

7 3,000 seed or 10,000 seeds, there's going to

8 be sampling error. And it doesn't matter what

9 the seed size is in that regard in some

10 respects. Certainly there is statistics

11 around that.

12 The other error is the lab error. 

13 When the tests are that sensitive there is an

14 inherent level of false positives in the labs.

15 For purity reasons the summary I

16 would say is, again, the Federal Seed Act is

17 the standard for genetic purity. Adoption of

18 things like the Association of Official Seed

19 Certification protocols is testing positive

20 for adventitious presence does not prevent an

21 organic producer from receiving a label or

22 certification. 
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1 For market reasons if a threshold

2 is necessary certified seed standards might be

3 something to consider. Testing for

4 adventitious presence in conventional organic

5 seed needs to be addressed on a crop-by-crop

6 basis. Sample size would be different. Some

7 crops don't have transgenics.

8 Studies have indicated the

9 stricter the AP/LLP requirements, the higher

10 the cost of seed production. And that's not

11 just the cost of testing, that's also the cost

12 of producing the seed and inventory cost. And

13 those additional costs would be passed onto

14 consumers as well.

15 I think a final statement to say

16 is the seed industry, we are willing to keep

17 the dialogue open on this issue as we feel it

18 can lead to a reasonable conclusion for all

19 parties involved. Thank you.

20 MS. SONNABEND: Thank you. Any

21 questions? 

22 MR. FOSTER: I was looking at the
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1 written public comment you sent in. Does that

2 slide showing the process, the nice flow

3 chart, is that part of your written comment?

4 MR. LANGER: That is not part of

5 the written comment, no.

6 MR. FOSTER: That would be a

7 helpful diagram for me to look at again and

8 again, so if there's some mechanism to get

9 that to me or the board I certainly would

10 appreciate that.

11 MR. LANGER: Michelle has it on

12 her computer.

13 MR. FOSTER: That would be really

14 helpful. It's -- after this many days it's

15 very helpful to have pictures to look at.

16 MR. LANGER: Right. I understand.

17 MR. FOSTER: And then the -- oh. 

18 The -- I'll ask you kind of the same question

19 I asked Beth. How do you see a seed purity

20 standard affecting the growers? I know it's

21 not your world necessarily but my concern is

22 organic growers. So how do you see that
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1 shaking out relative to the burden of testing

2 on organic crop producers?

3 MR. LANGER: Well, I think I

4 understand your question from the standpoint

5 that it would be a consideration if we

6 establish a threshold for seed that it would

7 be the next logical step that somebody might

8 consider there needs to be a threshold for the

9 resulting product from the organic growers. 

10 So you know, I can't sit here and say if that

11 would occur but that would certainly come to

12 people's minds I would think, yes.

13 MR. STONE: certifiers are

14 checking the -- we've heard that some of the

15 previous generations may have had some version

16 of excluded method and as the technology

17 changes our definition of, quote, "excluded

18 methods" may not hold up in the modern world. 

19 So there's -- I don't know how to ask the

20 question even of how many -- could there be

21 seed development further up the food chain but

22 then it appears as a organic product by the
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1 time it gets to the producer because of these

2 generational development of seeds? Or is it

3 more direct than what we're being told?

4 MR. LANGER: Well, I'm not sure I

5 understand your question but if --

6 MR. STONE: I'm not sure I do

7 either.

8 MR. LANGER: Let me offer a

9 suggested answer then. But with new research

10 techniques there's things, like you can,

11 genetically you can remove a transgenic event

12 from a product. So things like that. So it

13 was, you know, of course in Europe the issue

14 of "derived from" comes up as an issue as

15 well. So, I mean those type of things.

16 Typically today in the research

17 process for transgenics, it's a parallel

18 process between our base germ plasm breeding

19 and our transgenic efforts, then our back20 cross the transgenic into the base breeding. 

21 So there is -- I know there's been

22 some concern about there won't be any germ
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1 plasm but in fact today there is base germ

2 plasm that does not get exposed to

3 transgenics. Now, eventually a lot of it does

4 with the crops that are involved in the

5 transgenic aspects of the market.

6 MR. MARAVELL: I have two or three

7 questions but I just wanted to make sure I

8 understood something. You said that if you go

9 back in your parentage and you are indeed

10 using a genetically modified strain to get to

11 your current hybrid are you indicating that

12 that would no longer be considered a

13 genetically modified seed? And number two,

14 did you also say that you can go back and

15 reconstruct, in effect take a genetic event

16 out of a seed line?

17 MR. LANGER: Well, for labeling

18 purposes as in the Federal Seed Act and the

19 guidelines we have from the trait providers

20 usually in the seed aspects, if it's a

21 transgenic it's labeled as a transgenic. 

22 That's the way all those around the label of
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1 any seed that's sold.

2 I'm saying on the removal of the

3 transgene it's technically possible. If

4 there's a transgene inserted, we know where

5 it's inserted in the genome and you can

6 actually take it out actually through breeding

7 process. Because it's just like transgenic

8 has genetically enhanced whatever and in some

9 respects definition we've been doing

10 genetically enhanced forever. 

11 We've been -- humans have been

12 making selection and characterization and

13 picking out inadvertent mutations for

14 thousands of years. So in some respects we've

15 been doing that forever.

16 MR. MARAVELL: Could you elaborate

17 a little bit about the additional costs? Many

18 people are looking at this as a testing 

19 burden. I guess I should in the interest of

20 full disclosure say that I am a seed producer,

21 organically certified seed producer, corn,

22 soybean seeds among other seeds.
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1 There are many other costs which

2 actually far exceed the testing cost of

3 establishing seed purity. And I was wondering

4 if you could just give your read on those,

5 just give some definition or some description

6 of all the things that a seed producer may

7 have to go through in trying to ensure purity

8 and absence of GMO that would not involve just

9 a testing cost.

10 MR. LANGER: Right, right, and

11 that's the point is I think the testing would

12 actually be the small cost. In the seed

13 production you'd have to take -- maybe you

14 want to take extra steps to ensure that you

15 would reduce the probability of having

16 adventitious presence. Maybe that is

17 increased isolation distance which would have

18 a cost associated with it. Maybe it's a

19 separate line in your conditioning operation

20 to keep the non-GE or the organic separate

21 from the other. That would have a cost to it. 

22 Physical separation and stands to make sure
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1 that things are kept physically separated

2 would have a cost to it. 

3 And I think one of the largest

4 costs actually would be inventory costs. 

5 Because if you do the testing and monitoring

6 and you find out some lots do not meet

7 whatever the requirement is then all of a

8 sudden you may have just doubled your cost of

9 production on something for that customer. So

10 I think the inventory cost is actually the

11 largest cost but there is a lot of best

12 practices that have a cost associated with

13 them as well.

14 MS. SONNABEND: Thank you very

15 much.

16 MR. LANGER: All right, thank you.

17 MS. SONNABEND: Our next person is

18 Kristina Hubbard from Organic Seed Alliance.

19 MS. HUBBARD: Good morning. My

20 name is Kristina Hubbard and I'm the director

21 of advocacy and communications for Organic

22 Seed Alliance. OSA is also a member of the
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1 National Organic Coalition and my comments

2 reflect their position as well.

3 We are so grateful that the NOSB

4 is taking seriously the threat of GMOs to the

5 integrity of the organic label through the Ad

6 Hoc Subcommittee, through the thoughtful

7 discussion document. 

8 And we also applaud the NOSB's

9 decision earlier this year to send a letter to

10 Secretary Vilsack outlining our organic

11 community's longstanding concerns about,

12 again, the threat of genetically engineered

13 products to the integrity of organic. We

14 believe this is a really important first step

15 since I think we can all agree that the onus

16 cannot and should not remain solely on the

17 shoulders of organic. 

18 While we do have some questions

19 and concerns about some of the proposals I

20 don't want any of my comments to be construed

21 as supporting a do-nothing policy. We fully

22 support the GMO Subcommittee's efforts on this
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1 issue and look forward to supporting your

2 ongoing efforts in any way we can.

3 Genetically engineered seed has

4 been planted in our fields and sold in the

5 marketplace for more than 15 years, yet we

6 lack a profound amount of knowledge on the

7 state of genetic purity of our seed. And the

8 USDA to date has not afforded the agricultural

9 community a transparent testing and monitoring

10 system that would provide useful data for

11 better understanding the state of

12 contamination in our breeding lines and seed

13 sold as organic.

14 We hope the NOSB will explore the

15 best way to collect this data, as Zea

16 mentioned perhaps through the ERS, or other

17 means. We believe this data is especially

18 important to understanding the feasibility of

19 a genetic purity standard. And ideally this

20 data would be made available publicly to

21 stakeholders and be accompanied by testing

22 protocols, proven prevention measures and
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1 ongoing monitoring to ensure the access to

2 seed that meets an appropriate genetic purity

3 standard should one be implemented.

4 On the topic of a genetic purity

5 standard we believe the standard may be

6 warranted in at-risk seed, especially corn,

7 but we do caution against implementing it too

8 soon before some serious questions are

9 examined and explored. We're concerned that

10 what may seem like an easy solution could lead

11 to consequences that we have identified as

12 potential consequences, identified in some

13 questions that we developed and provided in

14 written comments. 

15 We have been talking to a number

16 of stakeholders over the last year actually

17 about the adequacy and again any potential

18 consequences of a genetic purity standard. We

19 are most concerned that the standard should

20 not overly burden organic farmers or

21 discourage the overall growth of the organic

22 industry. 
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1 We're concerned about the

2 standard's effect on the commercial

3 availability of organic seed which is also an

4 organic seed integrity issue. We don't want

5 to discourage farmers who are producing

6 organic seed or private firms investing in

7 organic seed production and breeding, or

8 simply lose organic farmers who decide that

9 the cost of certifications are simply too

10 great.

11 Testing is absolutely necessary. 

12 Farmers need access to information about the

13 genetic purity of the seed they're planting to

14 organic systems, but this cannot happen at the

15 total expense of organic farmers and

16 certifiers. 

17 Earlier this year we completed a

18 survey with companies who supply organic seed. 

19 The purpose was to start to identify some of

20 the risks that these companies are facing in

21 supplying organic seed and what the state of

22 contamination is in the seed that they're
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1 producing and selling. 

2 I encourage and hope that you read

3 through some of our findings in the written

4 comments. Not only do these findings show

5 more evidence of the problem, they do show

6 some uncertainty among companies about a

7 genetic purity standard, at least putting one

8 in place at this time.

9 As you've heard today, some

10 companies say that they can meet the standard

11 consistently while others have serious

12 concerns that without safety nets to cover

13 ongoing incidences of GE contamination the

14 financial burden and risk to organic seed

15 companies will become too great.

16 Thank you for your work on this

17 issue and again we look forward to working

18 with you in any way we can to support your

19 efforts to move this conversation forward.

20 MS. SONNABEND: Thank you, Kiki. 

21 We will take a few questions but understanding

22 that there will be more opportunity to ask
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1 questions of Kiki later when she gives a

2 presentation.

3 MR. FELDMAN: Thank you. I guess

4 I wanted to put this thing in perspective. 

5 And we're talking about seed purity. Can we

6 back up a step and talk about the thinking

7 that you all have done on prevention in the

8 area of -- I mean as Zea mentioned, there was

9 real interest on the part of the subcommittee

10 in terms of identifying preventive strategies

11 and working with USDA and enforcement against

12 what she described as trespass. 

13 How do we go down that road? What

14 can the NOSB do to sort of elevate that issue

15 or advance it in a better way?

16 MS. HUBBARD: Well, first of all I

17 think we just need to acknowledge that already

18 organic farmers and other stakeholders in the

19 organic community are doing testing at times

20 and taking measures to prevent contamination. 

21 In fact, it's mandated through the organic

22 system's plans.
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1 I passed around an article that I

2 recently had published in the peer-reviewed

3 journal Agriculture and Human Values. There

4 are further recommendations in that that point

5 to the inadequacy of the current biotech --

6 the current regulatory framework for biotech

7 crops as well as the role that the NOP plays

8 in protecting the genetic integrity of organic

9 food.

10 I know it is not an appealing

11 recommendation but I believe applying further

12 pressure on the USDA to fulfill their

13 obligation to the success of organic means

14 that they have to more fully confront in a

15 meaningful way the issue of contamination

16 prevention. Currently there is no requirement

17 on the part of growers and owners of

18 biotechnology products to prevent

19 contamination in the field. 

20 That said, again I think the NOSB

21 should continue to explore some of the

22 questions that we raised in our written
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1 comments and to engage diverse stakeholders. 

2 Seed companies being the primary stakeholders

3 that should be at the table, both those who

4 believe that they are successfully preventing

5 contamination as well as those who are doing

6 their best and despite honest efforts not

7 having a ton of success meeting the standard

8 as proposed in the discussion document.

9 There is -- all the companies that

10 I spoke with for the survey, the fuel crop

11 companies, do conduct testing and they have

12 internal thresholds. And a lot of times they

13 are diverting seed that exceeds their internal

14 thresholds to the non-organic seed

15 marketplace, taking that financial hit. As we

16 know there is no compensation mechanism in

17 place to cover any of these costs and testing

18 alone for some of these small to mid-sized

19 scale companies ranges anywhere from forty to

20 seventy thousand dollars a year.

21 I will too say that there is an

22 opportunity for the NOSB to voice on behalf of
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1 the organic community concern with some of the

2 recommendations coming out of the USDA's

3 Advisory Committee for Biotechnology. The

4 AC21 committee has been charged with exploring

5 an appropriate compensation mechanism in

6 instances of economic harm resulting from the

7 unwanted presence of genetically engineered

8 material. 

9 Unfortunately their recommendation

10 worsens the status quo by saying organic

11 farmers should purchase crop insurance to

12 self-insure against potential harm. I believe

13 it's a really important for this board to

14 weigh in on that discussion as well.

15 MS. SONNABEND: Okay. Thank you,

16 Kiki. I'd like to use our remaining few

17 minutes to ask if the board, especially those

18 who are not on the committee to already

19 discuss this have any discussion points they

20 would like to bring up on the discussion

21 document. 

22 Thoughts for our committee,
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1 subcommittee, to move forward. Anyone? No. 

2 Then that concludes the presentation of the

3 GMO Subcommittee and we look forward to our

4 future work.

5 DR. GRANATSTEIN: Thank you, Zea. 

6 We'll take a break now and we'll return at --

7 MS. SONNABEND: Michelle is asking

8 to hold a minute. Do we have another

9 commenter? Sorry.

10 MR. KITTREDGE: Hi, I signed up

11 outside on the table and I guess nobody got

12 that. 

13 MS. SONNABEND: Okay.

14 MR. KITTREDGE: My name is Jack

15 Kittredge. I'm with the Northeast Organic

16 Farming Association, Massachusetts chapter. 

17 I want to first thank you for

18 visiting in New England. It's very nice that

19 you have come and I'd like to -- I know some

20 of our farmers and representatives of NOFA

21 will be here to speak with you. 

22 We represent a somewhat unique
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1 region in that our farming is at a very far

2 different scale for most of us. We represent

3 farmers' markets, farm stands, CSAs. We're

4 not talking about the major kinds of crop

5 production acreages but rather small high6 value crops. 

7 But we are very much concerned

8 about this issue of genetic modification. We

9 think that already in some areas farmers have

10 dropped corn, for instance, as a product

11 because of the issue of contamination. There

12 is already some corn and soy production in our

13 region that we're concerned about. 

14 We're much more concerned about

15 the developing line of crops that are going to

16 be directly modified we believe that are in

17 the pipeline now and that will be increasingly

18 of concern to our farmers who are producing

19 these high-value crops. As these genetically

20 modified crops become available and

21 contamination takes place, and we do believe

22 it's contamination because we do not believe
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1 there's effective regulation of health and

2 safety at the federal level. So it is

3 contamination or pollution in our minds.

4 The primary way that the current

5 level of genetic modification is affecting us

6 is through animal feed. We find increasingly

7 there is a local agricultural movement that is

8 strongly supported by our consumers and we're

9 glad to see that. But a number of those

10 producers say we would love to be organic but

11 we cannot afford to buy organic feed and

12 therefore we're going to have to buy local

13 feed. And it turns out that of course much of

14 that feed is GMO. And so for us this is

15 becoming a life or death issue at that level

16 even before the new variety issue becomes more

17 apparent.

18 In terms of solutions we think

19 that obviously testing by farmers is not a

20 realistic thing, especially in our region

21 where farmers are very small. They're going

22 to drop those crops long before they're going
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1 to be able to afford testing. I agree with

2 Kiki that insurance is not realistic. I would

3 love to see the NOSB speak out against that

4 insurance plan and against the whole idea of

5 coexistence with GMOs which we believe is not

6 realistic.

7 Some of the things that would be

8 helpful that the USDA could do, maybe some

9 random testing by the USDA of different kinds

10 of crops and samples so that we could get a

11 sense of where we are in terms of the level of

12 threat. Identify contamination sources. Set

13 up some protocols to deal with that. Develop

14 compensation schemes that are in fact

15 realistic and enable small farmers to deal

16 with these problems. One of our members once

17 suggested if GMOs are like pesticide

18 contamination why shouldn't we license GMO

19 farmers and they should be trained so that

20 they can plant things properly instead of

21 contaminating their neighbors. Interesting

22 direction. 
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1 But probably the most important

2 realistic thing that USDA can do is help in

3 developing non-GMO seed varieties, and we

4 would like to see as much energy put in that

5 direction as possible because ultimately we

6 are going to have to have seeds that are

7 developed and bred for organic farming

8 purposes. So, thank you very much.

9 MS. SONNABEND: Thank you. Are

10 there any questions from the board?

11 MR. FOSTER: No surprise here. 

12 Amongst your grower community is there

13 awareness or concern or discussion over the

14 cost that establishment of thresholds might

15 have for them? Is that part of the dialogue? 

16 And if so, what's the -- can you capture that?

17 MR. KITTREDGE: Yes. Very little

18 in Massachusetts. We have virtually no

19 farming of this nature. A little bit more,

20 some of our other states, Vermont, New York

21 have more serious grain crop farming

22 operations. But in Massachusetts there has
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1 been none really.

2 MS. SONNABEND: Okay, thank you. 

3 Now we conclude the presentation of the GMO

4 Subcommittee. 

5 DR. GRANATSTEIN: Thank you. That

6 concludes the GMO presentation. We'll take a

7 break and return at 9:20 and begin the Crop

8 Subcommittee discussions. 

9 (Whereupon, the foregoing matter

10 went off the record at 9:08 a.m. and went back

11 on the record at 9:31 a.m.)

12 CHAIRPERSON FLAMM: We're now back

13 in order. The next session will be Crops

14 Subcommittee and I'll turn the gavel over to

15 the subcommittee chair Jay Feldman.

16 MR. FELDMAN: Thank you, Barry. 

17 Just to lay out the process for everybody we

18 have a number of materials we need to get

19 through. And we've allocated -- and this is

20 for the board specifically just so you know. 

21 We've allocated 13 minutes for every material

22 that we'll be discussing, 5 for presentation
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1 and 8 for discussion except for bioplastic. 

2 We've left 10 for the presentation and 12 for

3 discussion. 

4 Now, remember we have a lot of

5 witnesses today so we'll have more time to

6 discuss with the witnesses. But just, we're

7 going to be moving at a pretty quick clip

8 here. And I apologize in advance if I have to

9 interrupt you so that we can move this thing

10 along. Because when -- we don't want to stand

11 between these folks and lunch. That's always

12 a problem for us.

13 Okay, so the first material,

14 Carmela is going to lead us on ferric

15 phosphate. I'm sorry, I need to recognize

16 Lisa first to explain the petition and the

17 background on this. Thank you.

18 MS. BRINES: Thank you, Jay. Yes,

19 the first petition on the agenda for the Crops

20 Subcommittee today is ferric phosphate. This

21 petition was received on July 7, 2009 and was

22 submitted by Steptoe & Johnson.
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1 The petition requests the removal

2 of ferric phosphate from Section 205.601(h) of

3 the National List. It's currently permitted

4 as a slug or snail bait.

5 There's three pieces of technical

6 information that's available for this petition

7 substance. There was an original technical

8 advisory panel report prepared in July 2004 in

9 response to the original petition to list this

10 material. 

11 And there have been two additional

12 technical reports since that date. There was

13 one prepared in 2011 and then a supplemental

14 technical report that was prepared and

15 available in 2012. Both the petition and the

16 three technical reports were available and

17 posted on the NOP website in advance of the

18 opening of the public comment period.

19 There was written comment received

20 in response to this proposal and the

21 petitioner is signed up for in-person public

22 comment as well. Thanks.
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1 MR. FELDMAN: Thank you. Carmela.

2 MS. BECK: Okay, so the Crops

3 Subcommittee recommends to vote down the

4 petition to remove ferric phosphate from the

5 National List. The generic active ingredient,

6 ferric phosphate, needs to be considered

7 separately from any other ingredient, either

8 active or inert.

9 The supplemental TR addressed four

10 questions that are posted on the screen. And

11 I'm not going to go through the questions or

12 the answers as most of you have probably

13 already read those. So I'll jump straight to

14 the public comment. 

15 The total in favor of maintaining

16 the listing of ferric phosphate were 26. Of

17 those 26, 17 were farmers, 4 were consumers

18 and 5 were organizations. 

19 Those in favor of keeping ferric

20 phosphate on the National List cited the

21 following reasons. One, research has shown

22 that ferric phosphate by itself does have an
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1 effect on snails and should not be prohibited

2 because EDTA is questionable. 

3 Second, EDTA is an allowed list

4 for inert per 205.601(m). Three, the Inerts

5 Working Group will determine inerts policy

6 within the next 5 years. Four, currently

7 there is no process in place to add or remove

8 allowed inerts.

9 Five, in 2010 the NOSB re-listed

10 the EPA list for inerts until 2017. Six, in

11 2010 the NOSB re-listed ferric phosphate on

12 the National List.

13 Seven, essentiality. Eight, that

14 there is a real lack of effective practical

15 alternatives. And the last reason cited was

16 that there's a large potential for detrimental

17 economic yield and ecological consequences if

18 the product is removed.

19 The total in favor of de-listing

20 ferric phosphate was 11. There were zero

21 farmers, nine consumers and two organizations. 

22 Those in favor of de-listing
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1 ferric phosphate cited the following. One,

2 lack of essentiality. Two, incompatibility

3 with organic agriculture. Three, availability

4 of cultural practices and alternative control

5 measures. Four, the TR documented a negative

6 impact on earthworms and soil organisms. 

7 The ARS report and supplemental TR

8 responses supported the petition's reasons for

9 removal. They state that the argument is that

10 due to the 2007 sodium hydroxyl EDTA petition,

11 due to the fact that that was denied by the

12 NOSB the same argument should be carried

13 forward and that the NOP should now prohibit

14 EDTA in all organic formulations.

15 The commenters feel that the NOSB

16 can't wait on the Inerts Working Group for

17 forthcoming recommendations. In line with the

18 Crops Subcommittee minority opinion ferric

19 phosphate is not effective alone. It must be

20 combined with a synergist such as EDTA to

21 function.

22 I'm going to go ahead and let Zea
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1 continue the conversation.

2 MS. SONNABEND: The majority of

3 the Crops Subcommittee did vote in favor of

4 maintaining the listing of ferric phosphate. 

5 And truthfully for me as well as a number of

6 the others in the majority the key reason has

7 to do with proper materials review, procedures

8 and protocol. It is not the right thing to

9 remove an item from the list because something

10 else that might be used with that item is a

11 problem. The correct thing would be to put an

12 annotation on that so that it could not be

13 formulated with the other thing if it's shown

14 to be a problem.

15 The key question here then boiled

16 down to -- and there was a lot of -- if I want

17 to say red herrings and unclear information

18 because both sides tried to impress us with

19 volume in their comments I would say. And it

20 was hard to drill down through everything to

21 get to what the key issues were. That's one

22 of the things that took so long. And also to
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1 try and get some unbiased information.

2 So the key thing here is whether

3 ferric phosphate belongs on the list by itself

4 because it does have an effect against snails

5 and slugs. And there were three studies that

6 did show that by itself it had some activity. 

7 One of those studies was very hard

8 to find because it had been redacted when it

9 was first sent in as the comments. And the

10 whole study was redacted even though only one

11 clause of it actually was the confidential

12 information. So we did finally get that study

13 after the docket closed and it will be posted

14 into the docket after the meeting I believe. 

15 And that study as well as the

16 other two showed clearly that the ferric

17 phosphate by itself had some activity against

18 snails, more activity than either EDTA by

19 itself or nothing, the two controls. But

20 there's more activity when the ferric

21 phosphate is combined with EDTA, but that

22 doesn't mean that without EDTA it doesn't have
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1 some activity.

2 So, because we are going to be

3 reviewing EDTA in our proposal on inerts that

4 we'll be talking about in a few minutes, and

5 that review can happen within the next 3 to 5

6 years the majority of the committee felt that

7 ferric phosphate should be kept on the list. 

8 Thank you.

9 MR. FELDMAN: Board discussion. 

10 Any questions? Calvin.

11 MR. WALKER: The TR. My question

12 is how was the additional information not in

13 the TR. Because there seemed to be a lot of

14 information that came afterwards.

15 MS. SONNABEND: In 2010 when

16 public comments were accepted on this quite a

17 bit of the attachments were redacted as

18 confidential business information. Typically

19 the TR contractor does not have access to the

20 redacted information nor do we. And therefore

21 when we asked for a supplemental TR and we

22 asked them to review all the new information
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1 that was submitted they could only review the

2 information that was accessible to them, and

3 that's how it got missed. And similarly the

4 ARS who we asked for a further objective

5 opinion, they had access to otherwise of the

6 three studies, but not the third one.

7 Clarification from Lisa, I

8 believe.

9 MS. BRINES: Yes. For the

10 supplemental technical report, the most recent

11 one, the contractor did have access to the

12 confidential business information from the

13 original petition as well as I believe the

14 second petition that came in to remove it. 

15 Thank you.

16 MR. FELDMAN: Other questions? 

17 I'd like to just make a quick comment on this

18 because I sort of led the charge on the flip

19 side of this. And just to point out that we

20 did do a supplemental TR on this question of

21 the active properties of EDTA. 

22 And this is where there is
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1 disagreement. Obviously the manufacturer of

2 this product claimed that the ingredient that

3 is at issue here was an inert, or is an inert

4 ingredient. And this board has previously

5 denied this product as an active ingredient. 

6 It was applied as an active ingredient. And

7 the TR, this is sodium hydroxyl. And the TR

8 supplemental indicated that yes, in fact these

9 were the same materials. 

10 So really what this comes down to

11 is that there is a difference of opinion as to

12 whether this actual product formulation can

13 work, can have efficacy, without the use of

14 this particular ingredient as -- because of

15 its active properties. 

16 Having said all that, Zea's

17 correct. We will be evaluating this material

18 one way or another. We'll either make a

19 choice on it today or we will do it through

20 the inerts process. So I think that's an

21 important point to keep in mind as you think

22 about this and ask questions of the
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1 commenters. Just, that's a clarification and

2 hopefully you feel it's accurate. Okay.

3 So now we'll move on. Unless

4 there are any other questions on that we'll

5 move onto the next material on the list which

6 is oxidized lignite. Zea will be managing

7 this and we'll turn first to Lisa on the

8 petition.

9 MS. BRINES: Thanks, Jay. This

10 petition was received on June 22, 2011 and was

11 submitted by SHAC Environmental Products

12 Incorporated. 

13 The petition requests the addition

14 of oxidized lignite to Section 205.601 of the

15 National List for use as a soil amendment. 

16 There is one related listing currently on the

17 National List regarding this particular

18 product because it is a humic acid derivative. 

19 There is a current allowance at Section

20 205.601(j)(3) for humic acids, naturally

21 occurring deposits, water and alkali extracts

22 only.
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1 In its review the Crops

2 Subcommittee did request the development of a

3 new technical report in response to the

4 petition. There are also two previous

5 technical reports available that were

6 prepared, previously prepared in response to

7 the existing listings for humic acid, most

8 recently from 2006 and one from 1996 for the

9 original review of humic acid derivatives. 

10 Thank you.

11 MR. FELDMAN: Thank you. Zea?

12 MS. SONNABEND: Thank you. This

13 one was somewhat confusing to us as a

14 committee at first because it was unclear how

15 to exactly list the product. Although

16 commonly called oxidized lignite by the

17 manufacturer and others there is a truly non18 synthetic oxidized lignite that can occur in

19 nature in the process of humates being

20 oxidized by natural processes. 

21 And we didn't want to create a

22 listing that would somehow interfere with, be
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1 confused with a non-synthetic listing for

2 something that does appear to be synthetic. 

3 So the product in question was created

4 basically by taking the natural humates and

5 treating them with hydrogen peroxide. 

6 Hydrogen peroxide is on the National List by

7 itself and does serve the function of an

8 oxidizing agent, and creates a more readily

9 available humic acid derivative. 

10 And so it was decided that instead

11 of putting oxidized lignite on the list we

12 would call it another humic acid derivative

13 and propose the language that adding to what

14 is already in the rules which is humic acids

15 naturally occurring deposits, water and alkali

16 extracts only, and adding to that water,

17 alkali and hydrogen peroxide extracts only. 

18 And this would be the clearest listing for

19 everyone to be able to work with.

20 That being said we looked at our

21 OFPA and we looked at the rule and while this

22 material may in fact be preferable to the
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1 alkali extracted humic acids because it

2 doesn't -- the hydrogen peroxide leaves only

3 behind hydrogen and oxygen, but while the

4 alkali extracts leave behind excess synthetic

5 phosphorus or potassium. It was felt that

6 there was no real category in the exemptions

7 in OFPA to put synthetic fertilizers onto the

8 list, and therefore the committee -- Michelle,

9 can you scroll down to the committee vote? 

10 Because I can't remember what it was. But we

11 did not decide to put a committee

12 recommendation forward to add this to the

13 National List. Three yes and five no, thank

14 you.

15 The public comment consisted of

16 comments from the manufacturer and then a few

17 people who I didn't think were growers saying

18 that they didn't want more synthetics in

19 agriculture. And I didn't see any comments

20 from growers saying that they wanted or needed

21 this material except one from OGC that said

22 they thought this was a preferable material to
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1 the extract. But while they represent some

2 growers who are their clients they are

3 actually a handler.

4 MR. FELDMAN: Thank you, Zea. 

5 Questions? John.

6 MR. FOSTER: So my question is

7 around the ability to list synthetic

8 fertilizers. And to what degree -- I wasn't

9 part of the discussion on this, unfortunately. 

10 To what degree was the discussion focused on

11 whether this extract could be categorized as

12 a fertilizer versus a fertility input or a

13 soil amendment? How was that discussion

14 handled or was it?

15 MS. SONNABEND: Well, we did

16 discuss that in general but there's no

17 category for soil amendment or fertility input

18 either. And you know, my personal opinion,

19 and I'm stepping aside from the committee

20 here, but this appears to be way more benign

21 in general than other alkali derivatives. So

22 in a perfect agronomic world I would want this
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1 but I just don't see from an interpreter of

2 the OFPA and the federal rule how this could

3 be added.

4 MR. FOSTER: So, is alkali

5 extracted humic acid? So help me understand

6 that rationale.

7 MS. SONNABEND: That also is no

8 category for it but we weren't on the board

9 when that was put on.

10 MR. FOSTER: Okay, well -- okay. 

11 But someone was on the board when that passed.

12 (Laughter)

13 MR. FOSTER: So.

14 MS. SONNABEND: I was in the

15 audience. I remember it.

16 MR. FOSTER: So, I mean, I

17 understand you don't want to throw good money

18 after bad, for example, but if -- I'm going to

19 go back to one of my old saws is if we have

20 the opportunity to list a preferable material

21 it's hard for me to say no to that when we

22 have the opportunity. I mean, it sounds to me
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1 from your comment as well as others this is

2 clearly a preferable material to the alkali

3 extracted. Alkali extracted is on there. 

4 It's really hard for me to say no to something

5 that's better.

6 MR. FELDMAN: Other questions? 

7 Thank you. And we'll get a chance to ask

8 questions about this as we proceed here.

9 The next material is propylene

10 glycol monolaurate. We refer to it as PGML. 

11 So Lisa, if you could cue that up. Thank you.

12 MS. BRINES: Thanks, Jay. The

13 petition for PGML was received on April 24,

14 2009, and was submitted by the Technology

15 Services Group Incorporated. 

16 The petition requests the addition

17 of propylene glycol monolaurate to Section

18 205.601 of the National List for use as a

19 miticide and acaricide.

20 In support of the review of this

21 material the Crops Subcommittee did request

22 the development of a technical report. The
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1 report was developed and both the report and

2 the petition were posted on the NOP website in

3 advance of the opening of the public comment

4 period. Thanks.

5 MR. FELDMAN: Your voice was

6 trailing off at the end there so I know it's

7 a lot to --

8 MS. BRINES: I'll get closer to

9 the mike. Thanks.

10 MR. FELDMAN: Thank you, Colehour,

11 for leading us on this.

12 MR. BONDERA: Very good, thank

13 you. I hesitate since -- is it going to be up

14 on the screen, Michelle? Yes.

15 So, propylene glycol monolaurate

16 (PGML), petition to add it to 205.601(e) is

17 the topic. And PGML is petitioned as an

18 acaricide which is a pesticide that kills

19 members of the acari group, ticks and mites.

20 The petition states that the PGML

21 is, quote, "a broad-spectrum antimicrobial

22 agent to control fungi and bacteria that cause
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1 decay of post-harvest fruit and vegetables." 

2 So we did go through the process

3 and Crops Subcommittee members were to some

4 degree divided. And those that were in

5 support of PGML I summarized their thoughts

6 into these three. 

7 While there are other organic

8 options they are very sporadic in their

9 control. The impact of crop quality and the

10 potential environmental impact when using the

11 alternative materials can be somewhat of a

12 concern as well. And then third is we can

13 give organic farmers another tool that is

14 better than those they currently rely upon if

15 we can properly look at the risk-benefits.

16 The majority of the Crops

17 Subcommittee opposed the petition and said

18 that it is not needed as it can be substituted

19 with alternatives, including cultural

20 practices as well as biological controls; that

21 the other options do not have the impacts on

22 human and environmental health; that the
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1 environmental impacts leave more damage

2 overall than the benefit; and that as a

3 synthetic product and tool designed for non4 organic agriculture this material is not

5 consistent with either organic or sustainable

6 production systems because it is a broad

7 spectrum and affects beneficial predators as

8 well as the target mites.

9 So, commenters are opposed to

10 listing of PGML, saying things such as PGML

11 kills natural predators that control the mite

12 pests, that it reduces biodiversity on organic

13 farms, that its manufacture is fossil fuel14 dependent, that it is not essential and may

15 actually exacerbate problems, and that it's

16 incompatible with organic production because

17 it's not in any allowed category of synthetic

18 input and is a broad-spectrum pesticide. 

19 And in summary our classification

20 vote and our listing motion vote were such as

21 you see there. Like I said, we were divided. 

22 It was two people in favor and six opposed on
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1 listing it. And that's all I had. Thank you.

2 MR. FELDMAN: Board discussion. 

3 That gives me more time for inerts. Thank

4 you. Okay. 

5 I will cue this one up since it's

6 not a petitioned material. Oh, thank you. 

7 Thank you, Michelle.

8 Let me run through this

9 PowerPoint. We are -- obviously we as a

10 community have addressed this issue for many

11 years, the policy and procedure proposal for

12 inert or so-called "other" ingredients in

13 pesticide formulations on the National List. 

14 So, by way of background, and Zea

15 will be helping me with this, or feel free to

16 chime in at any point since she was so

17 instrumental. We'll get to the committee and

18 who all worked on this. But as background

19 we're dealing with inert ingredients and as

20 all of you know I hope we have a definition

21 for this. And it goes back to the EPA

22 definition as well. So the definition on the
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1 screen here is both the definition for inert

2 and active and how they are distinguished. 

3 What is clear to us all as a

4 community is that the word "ingredient" in

5 found in both of this and that's what is

6 driving this process on the one hand.

7 The statute, the Organic Foods

8 Production Act, has identified inerts of

9 toxicological concern as a focus for us here. 

10 And so typically what we've looked at in the

11 past are the lists 4(a) and 4(b) eventually,

12 a category of inerts that were allowed as a

13 group by -- under the National List in

14 addition to list 3 inerts that were allowed in

15 certain pheromone dispensers.

16 The other element that's driving

17 this process besides a concern about inerts

18 generally -- or ingredients generally is the

19 fact that EPA decided that it was no longer

20 going to maintain a list of inerts. So that

21 left the NOSB with somewhat of a problem in

22 terms of what it would do if it couldn't
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1 reference an EPA list that was kept up to

2 date.

3 So as a result of all this we

4 formed the working group with NOP and EPA and

5 NOSB. And that group met for a couple of

6 years. Zea joined the group last year when

7 she joined the NOSB. And we brought a

8 discussion document as you recall to this body

9 back in the fall of 2011. 

10 The Inerts Working Group developed

11 this proposal which as a matter of process

12 went to the Crops Committee which then brought

13 the proposal or the discussion document to the

14 board. And we summarized the results of that

15 discussion document at our spring meeting.

16 So this is what we're proposing

17 today, basically a road map for beginning this

18 process of inerts review. The concern of

19 course was that this was an overwhelming task

20 and there were a lot of materials. So part of

21 the role of the Inerts Working Group was to

22 figure out what the scope of this project was
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1 and whether it was feasible, in what time

2 frame and so forth. 

3 So, we -- our goal here as we're

4 proposing it today is to put together a road

5 map that would address the requirement for

6 review under 205.601 which is crops and 603

7 which is livestock as these materials move

8 through the process and as they affect the

9 allowance of materials on the National List.

10 So this is what we're proposing in

11 terms of both the working group and the Crops

12 Committee. This is coming to you with

13 unanimous support from the Crops Committee. 

14 New regulatory language, a series of steps to

15 use in preparing for inerts reviews, screening

16 guidelines that the technical reviews will

17 address, a tentative list of groupings that

18 will allow us to address multiple materials in

19 groups because of common mechanisms of effect

20 and so forth. And then a rough time line of

21 how we would review and complete that process. 

22 The new regulatory language would
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1 fit, as I said, into 601 and 603 and establish

2 a review for substances permitted for use in

3 minimal risk products. This is a category

4 that EPA uses under its Federal Insecticide,

5 Fungicide and Rodenticide Act Section 25(b)

6 and then a reserve list of approved or other

7 ingredients. So that simply replaces what's

8 in our language currently which is in the

9 document that you got, the committee document.

10 MS. SONNABEND: The procedure

11 includes several steps for review, grouping

12 the chemicals into clusters -- and we've given

13 you some examples of where we are at now but

14 we aren't done with the groupings. Full group

15 listing including chemicals to be presented in

16 spring 2013. Anticipated that four to six of

17 the clusters will be evaluated each year with

18 TRs and committee review of the TRs. 

19 Manufacturers will have time to identify

20 ingredients in use that are not on the list to

21 request review. And after completion of this

22 process new, other or inert ingredients must
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1 be petitioned.

2 MR. FELDMAN: Okay, so the

3 proposed procedure includes the NOSB working -

4 - continuing to work with the Inerts Working

5 Group to finalize the proposal. The NOSB will

6 rely on the working group to consult with OMRI

7 and WSDA, the Washington State Department of

8 Agriculture for updated inert lists. 

9 The NOSB will request that NOP

10 investigate and adopt within 6 months of the

11 announcement of this proposal which would be

12 the spring of 2013 the appropriate mechanism

13 for notifying manufacturers. And the NOSB

14 would request under this proposal that NOP

15 commission one TR per group except where noted

16 and coordinate review with the board.

17 And the NOSB again would request

18 that the NOP determine an appropriate format

19 and commission a special inerts TR for each

20 group. And here's, you know, this is

21 delineated in the documents you have. I'm not

22 going to read all this but these are the steps
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1 that we would go through.

2 And based on the results of the TR

3 the NOSB Crops Committee would accept these

4 groups to move forward to the NOSB agenda or

5 single out one element or one formulation, one

6 or another formulation or material that was

7 needed for individual review.

8 The NOSB working with the working

9 group will prioritize and order the reviews

10 considering based on a priority system that

11 looks at the most problematic first and then

12 works through those that are used most often

13 in organic production, et cetera.

14 And then this would be part of our

15 priority system, having a screening process

16 where we're trying to elevate to the head of

17 the class those materials that go through the

18 screen of highly toxic or ECOTOX or, you know,

19 indicative of some problem that we would

20 consider a concern when it comes to hazard or

21 adverse health effects.

22 These are the proposed clusters. 
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1 Right now we have, for about 126 inerts we

2 created 16 clusters. As noted by OMRI one of

3 those is a non-synthetic cluster. Why is that

4 on there? Well, it was one of the inert

5 materials that showed up so we figured we'd

6 put it on the list. We probably don't have to

7 review those. If they're non-synthetic

8 materials we don't have jurisdiction over

9 those unless they end up being ones that would

10 be natural that we would think we would need

11 to prohibit as we'll be discussing later like

12 with rotenone. But these are the categories,

13 alkali alcohol, alkali alkoxylates, I'm not

14 going to read them all. I'll let Zea read

15 them all. But -- I can't read them all.

16 The public comment, 17 supporting. 

17 We had one that was asking for clarification,

18 asking whether we really needed to look at

19 25(b) at all. There was this massive influx

20 of organic consumer association sign-ons to a

21 petition which was nice to see at least in

22 terms of public involvement. 
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1 Those supporting the proposal say

2 the review of inert ingredients is overdue. 

3 We've heard that for a couple of years. I

4 mentioned OMRI pointed out the 14 non5 synthetics. Wolf and DiMatteo stated again as

6 I said earlier that the 25(b) review is not

7 necessary and we'll be hearing from them

8 later.

9 There's some commenters who

10 expressed concern, and this is coming from,

11 you know, everybody has concern about the time

12 line, will it work. That's why this is a

13 procedure. During this procedure one of the

14 elements as I mentioned earlier is to assess

15 the viability of meeting the time frame. 

16 And then Wolf DiMatteo said it

17 would be helpful -- this is a useful comment -

18 - to include in this recommendation the list

19 of 126 individual inerts so that pesticide

20 formulators would be notified in advance of

21 the decision of the NOSB, so they know it's

22 coming.
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1 And then once we go through this

2 procedure if it's adopted by the board we'll

3 finalize a procedure by the spring meeting in

4 2013 to review all these things. We'll see if

5 it still looks like we can meet this schedule

6 by the 5-year sunset period that we have to

7 align with which is 2017 for the sunsetting of

8 the inert ingredients in the list 3 of

9 pheromones and pheromones in dispensers.

10 So that's our plan, that's our

11 proposal. I neglected to thank the NOP, Emily

12 and Lisa for their work on this. And the work

13 of the EPA staff, Chris Pfeiffer and Kerri

14 Leifer. Everybody put an extraordinary effort

15 into this. A lot of information had to be

16 evaluated and we all appreciate it very much.

17 Any questions? Yes.

18 MS. RICHARDSON: I'm not on Crops

19 Committee so it's sort of mind-blowing the

20 range of things that you're going to try to do

21 on this topic. 

22 And so what I'm sort of interested
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1 in trying to understand is really probably

2 just to get the perspective of NOP staff on

3 the feasibility of being able to deal with

4 such a large number of inerts in such a

5 relatively short time line.

6 MR. MCEVOY: Yes, we've looked at

7 this. We are concerned about the resources

8 that we would need to commit to make this

9 happen and the time frame. But we do need to

10 look at these inerts. They're in the list 1,

11 2, 3, 4, the EPA list of inerts is being

12 maintained. It just seems like the best

13 proposal in terms of moving forward. And so

14 we support getting on with this project and

15 let's see how it goes. 

16 The technical reports are probably

17 going to be a lot more complicated than ones

18 that have been done in the past on single

19 substances. So this is very technically

20 complex but we support moving forward. Let's

21 give it a go and the part that is really

22 important that's part of the proposal is that
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1 there's a reassessment how it's going I think,

2 what is it, a year into the process to see

3 whether or not the process needs to be tweaked

4 or the time frame needs to be modified to get

5 through all these substances.

6 MS. SONNABEND: Thank you. Partly

7 in response to Jane I think that while the NOP

8 has concerns, they have indicated that they

9 will be willing to do it. The truly scary

10 part of it is that you and I as board members

11 are going to have to be looking at and voting

12 for a lot of things that are like oxy-, loxy-,

13 epoxy-, -ethoxylate that we can't even

14 pronounce. And if we don't put them on it has

15 grave impact. 

16 We're going to have to do this

17 without knowing which products they're in

18 probably with a few exceptions, and the

19 outcome will have grave impacts on the

20 industry. And so that's the part that for me

21 is the hardest thing to grapple with but we

22 are going to have to come to terms with that.
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1 MS. RICHARDSON: So I want to

2 follow up that then, Zea. It's that I know

3 they're all inerts and therefore they just,

4 they do nothing, they just sit there, right? 

5 So, I would like to be sure that when we get

6 this scientific technical report coming in

7 that we really do ask them to address synergy

8 and synergistic impacts. Even though we're

9 not looking at individual products we do need

10 to understand the interactions and know, I

11 mean, a huge amount of detail really to make

12 a logical decision.

13 MR. FELDMAN: One thing we're

14 going to have to grapple with along those

15 lines is the limited information that is often

16 available on a lot of these materials. And

17 that's just a fact of life. Synergy is one

18 category of very limited information. So I

19 appreciate that comment.

20 MR. FOSTER: So, didn't we just

21 hear that we probably will be -- well, maybe

22 not me but the board will be looking at these
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1 materials outside of the context of each

2 formulation? So then the synergy question

3 becomes pretty much impossible. If you don't

4 know the context you won't know the synergy. 

5 So I know that's a vigorous head-nodding from

6 you, Jay.

7 MR. FELDMAN: It's true.

8 MR. FOSTER: And it is of concern

9 but if that's the realistic context or lack of

10 context that we have then that better be an

11 up-front kind of agreement or common

12 expectation we should have on that. Otherwise

13 it's not going to be a functional

14 deliberation.

15 MS. SONNABEND: Yes, that is true,

16 John. One of the things that I've been

17 grappling with is I would really like to give

18 some incentive for those companies who do

19 choose to disclose what their product is that

20 has those inerts. And some companies are

21 willing to. 

22 And for the ones who disclose it
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1 would be nice to give them some incentive like

2 getting their thing reviewed faster, or some

3 other way to say okay, if you disclose we can

4 review it better because we know what all the

5 inerts are. 

6 But that is one detail that while

7 I put in many drafts of our proposal we

8 couldn't really figure out what to say about

9 it. But we will have a call for voluntary

10 disclosure I'm sure in the process of doing

11 this.

12 MR. FELDMAN: Thank you. Other

13 questions? Okay. Oh, I'm sorry. Go ahead.

14 MR. MARAVELL: Sort of to follow

15 up on Jean and John's comments here. You

16 don't see a subsequent time period? That's

17 the wrong word. You don't see a subsequent

18 process of review where these questions of the

19 synergies will eventually come to light?

20 MR. FELDMAN: This is a systemic

21 problem that we have in terms of the

22 proprietary nature of this data. That is why
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1 it falls into this inerts category as you know

2 because manufacturers have been protected,

3 their proprietary interests have been

4 protected. 

5 Hopefully as Zea says we'll get to

6 a point in time where the organic community

7 believes and the manufacturers associated with

8 it that full transparency of product

9 ingredients on a formulation basis does not

10 hurt their proprietary interests and that it's

11 in the interest of public understanding and

12 the transparency of organic that we will have

13 full disclosure. At that point we can do

14 this, John. 

15 And I think in many cases, you

16 know, we have done this. OMRI has done it

17 under a protection clause. There are ways to

18 get around this. There may be some creative

19 ways down the road where the board can

20 envision having the ability to review these

21 things with some protection for the

22 manufacturer if they feel there are
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1 proprietary interests.

2 But to answer your question, Nick,

3 there is no way around that. The law provides

4 in the registration process for disclosure now

5 -- for non-disclosure. 

6 Now, having said that full

7 disclosure is required on 25(b) products. And

8 if you take the position that most

9 manufacturers involved with organic are moving

10 toward the 25(b) category they must disclose

11 all ingredients on the product label. So,

12 that's the silver lining in all of this and if

13 we drive products toward the 25(b) list we

14 will have full disclosure.

15 MR. FELDMAN: Thank you all. 

16 We'll move on to rotenone. And Zea is going

17 to cue this up because there was no petition

18 involved in this process.

19 MS. SONNABEND: We certifiers and

20 others in the industry have kept getting

21 questioned about rotenone since it's been in

22 the news a lot lately as more and more studies
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1 come out that show a link between rotenone and

2 Parkinson's disease. 

3 I feel our posted document goes

4 into the regulatory history, how the EPA short

5 of recalling it has accepted a voluntary

6 cancellation of the uses in the United States. 

7 Because much as we would like to be aware of

8 the whole world, but mostly we have to be

9 focused in United States policy we decided it

10 was time to take this up again. Also, the

11 OFPA calls for a special review of botanicals

12 before creation of the National List. 

13 This review was done in 1994. I

14 was there for it and helped prepare for the

15 review. At that time a lot less was known

16 about rotenone than is now and there was no

17 clear link to health effects.

18 In the course -- while the

19 transcript of the meeting doesn't say this,

20 but in the course of researching this paper we

21 found a statement from the board at that time

22 requesting from the program that the
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1 botanicals have a special review every 5

2 years.

3 Well, a little time has passed

4 since 1994 and we're only getting around to

5 re-review of one of them at this time. In the

6 re-review we have presented some of the more

7 recent literature. And it's important to note

8 that this literature shows a very strong link

9 between rotenone and Parkinson's disease for

10 the applicators and the people who are in

11 contact with this material. It does not show

12 any residual so there's no danger at all of a

13 consumer eating something that was sprayed

14 with rotenone and being exposed to the hazards

15 that lead to Parkinson's disease.

16 However, we couldn't in good

17 conscience leave something as allowed that had

18 such a clear health effect. And so the

19 committee is proposing adding it to the

20 prohibited natural list in Section 205.602.

21 The public comment, we received

22 relatively little public comment. Three
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1 people wrote specific comments against it,

2 against rotenone. I think we can infer from

3 all the comments that said no synthetics in

4 organics that they might extend that to

5 natural products that were shown to be

6 hazardous and we didn't count those but there

7 are quite a few of them as you know. 

8 And then we heard from banana

9 growers who it turns out we hadn't realized

10 this but it is commonly used in bananas in

11 many countries in Latin and South America. We

12 got four comments in from banana growers, one

13 of them representing 57 growers in Ecuador,

14 100 growers in Ecuador, thousands of growers

15 throughout Latin America and one family from

16 Peru. 

17 All of these expressed the issues

18 that there's no other control for thrips that

19 cause a staining on the fruits that make them

20 unmarketable, and that their main control at

21 the moment is alternating rotenone product

22 which is made in the countries in which it is
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1 used with pyrethrin products. And they stated

2 that they do this to avoid building resistance

3 to either one of the products. 

4 So, in response to this concern we

5 started looking into what alternatives there

6 might be at least in this country, recognizing

7 that these alternatives might not be available

8 or might not work or be researched in the

9 other countries. 

10 But we found that as far as this

11 country goes controls for thrips include

12 Entrust which is spinosad, Ryania, another

13 botanical which has recently been -- the

14 formula changed hands and the new company

15 intends to expand the label so it may be

16 labeled for more uses than it is now. 

17 Organocide, SucraShield and then some thrips

18 are susceptible to oils. Numerous parasitoids

19 attack thrips and some generalist predators

20 like minute pirate bugs, six-spotted thrip and

21 lacewing.

22 Also, we heard from an expert that
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1 there has never been reported resistance to

2 pyrethrin as they contain six different

3 compounds at least that are toxic to insects

4 and thrips and therefore have six modes of

5 action to the insects and so they have not

6 been able to mutate for it.

7 So, we realize a couple of things. 

8 We realize that all of these things we

9 mentioned may not be available in the

10 countries where the bananas are grown, but

11 this is a fairly long list and so some of

12 these things could start being researched and

13 start trying to determine what the

14 alternatives are.

15 And we also realize that unlike a

16 regular petitioned item we kind of sprang this

17 on people fairly quickly. When something is

18 petitioned there's usually at least a year in

19 which you're aware that the petition is in

20 progress and in TR and like that. 

21 And so the Crops Committee is

22 going to consider amending our motion so that
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1 it would say to add rotenone to the National

2 List 205.602 as a prohibited natural substance

3 to take effect on January 1, 2016. This will

4 give 3 years for the potential research and

5 development of alternatives. The Crops

6 Committee did not feel that we could not

7 prohibit it based on the very large volume of

8 research showing it has a link to health

9 problems. Thank you.

10 MR. FELDMAN: Thank you, Zea. 

11 Board questions? 

12 MR. MARAVELL: Zea or Jay or the

13 program may want to respond to this. Given

14 our normal process of making a recommendation

15 to the NOP and having a rule finally

16 implemented what's the likelihood that a final

17 rule would be issued before the proposed

18 phase-out date anyway? In other words, is the

19 phase-out date fairly consistent with what

20 might occur in the natural rulemaking process?

21 MR. MCEVOY: Well, the phase-out

22 date is for use within the United States and
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1 rotenone is not as far as we know being used

2 on organic production in the United States. So

3 we're talking about banning it for organic

4 production where it's used in foreign

5 countries. So, the phase-out date and the ban

6 on the use of rotenone in organic production

7 is not directly related.

8 MR. FELDMAN: Okay, that's helpful

9 because my question is if this board adopts

10 allowable materials, you know, in this case a

11 prohibition on a natural, doesn't that affect

12 all USDA certified, all labeled products

13 whether it's domestic or international?

14 MR. MCEVOY: Yes, that's right. 

15 It would affect all products that are produced

16 under the standard. Whether they're produced

17 domestically or in a foreign country they have

18 to meet the same requirement. 

19 MR. FELDMAN: Okay.

20 MR. MCEVOY: Yes.

21 MR. MARAVELL: My understanding,

22 and I could be wrong here, is that with the
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1 voluntary cancellation that any existing stock

2 of rotenone sort of still in the stream of

3 commerce, still on the shelf is still

4 permitted to be used or am I incorrect?

5 MS. SONNABEND: We received

6 information from the EPA fairly recently that

7 the existing stock had been used up as of

8 August of this year. This has been going on

9 for several years now. And one of the

10 citations showed a 2011 survey that showed

11 some still on the market but as of 2012 it is

12 now all gone.

13 MR. FELDMAN: But if a certifier

14 shows up, Nick, or an inspector and somehow

15 somebody -- you know, EPA doesn't know what's

16 in everybody's barn, right? Somehow somebody

17 has this stuff it wouldn't be illegal unless

18 it was prohibited. It would not be illegal. 

19 The existing -- there's no stop-use date in

20 other words. 

21 MR. MARAVELL: Right. So, I'm

22 just thinking of farmers. So there is going
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1 to be a specific date. Let's just say -- I

2 don't use rotenone personally, but let's just

3 say I was a farmer and I had rotenone tucked

4 in the back of my barn. There would be a date

5 though after which I would not be allowed to

6 use it if it were still in my possession. Am

7 I reading that correctly?

8 MR. MCEVOY: If we put it on the

9 National List as a prohibited natural then it

10 would not be allowed as of the date that it

11 became a prohibited natural substance.

12 MR. MARAVELL: And by specifying

13 that date now we're giving people notice.

14 MR. MCEVOY: Right, but it still

15 has to go through the proposed and final

16 rulemaking process. So it would not become

17 final until there was a final rule that put it

18 on the National List as a prohibited natural.

19 MR. MARAVELL: And I guess my

20 question is are we doing it right here, Miles? 

21 Do we have an appropriate date given how the

22 regulatory process sort of lumbers through the
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1 bureaucracy if I can be so blunt?

2 MR. MCEVOY: Yes. We think we

3 could get it completed by January 1st of 2016.

4 MR. MARAVELL: Thank you.

5 MR. FELDMAN: Zea.

6 MS. SONNABEND: Just to supplement

7 that. Oh, Melissa, do you want to go first?

8 MS. BAILEY: Just wanting to jump

9 in here. So, just for clarification. So if

10 the board makes a final recommendation here at

11 this meeting we have that recommendation. Say

12 we begin our rulemaking work which as you know

13 takes awhile. January `13, so we plan 2 years

14 for proposed to final rule. I'm just working

15 out the time line here. So we have a final

16 rule in place by January 2015. That would

17 give a 1-year notification to those foreign

18 operators who might be using this for

19 basically coming into compliance with that

20 effective date if that makes sense.

21 MS. SONNABEND: This is what I was

22 just about to say also. We chose that date
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1 because it's comfortable enough for the NOP to

2 go through rulemaking and yet unlike not

3 putting a date in there it gives a time

4 certain right now for the users to start

5 getting ready to expire. Because if we just

6 put when it's done with rulemaking that takes

7 variable amounts of time and is not as clear

8 to the end users as if we put a certain date

9 in it.

10 MR. FELDMAN: Other questions? 

11 John.

12 MR. FOSTER: So I think that the -

13 - I think the health information is pretty

14 compelling actually and probably is going to

15 sway me on this. As you all know I'm not a

16 big fan of taking tools out of the organic

17 grower's toolbox. I think this might be a

18 reasonable time to do that. 

19 But just for -- to make sure it's

20 on the table as part of the discussion. I'm

21 not sure I like the optics of 15 North

22 Americans telling what South Americans can and
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1 can't use in production right now. 

2 And since it is not through

3 anyone's fault, it just works out history is

4 such that it's used there. It's pretty

5 important it sounds like for some things

6 there. I just don't want to let the

7 conversation go on without recognizing that

8 this is one of the outcomes when organic

9 becomes a global thing. 

10 And back in the day when

11 regulations, certainly the precursors to the

12 regulation and precursors to OFPA were in

13 discussion this really wasn't part of the

14 thought process in like 1982 for example. So

15 this is one of the outcomes of having a lot of

16 success. And I don't want to let that moment

17 pass without recognizing that with that

18 success comes some much more hard decisions to

19 be made. This is one of them I think. 

20 And I didn't want to let that

21 moment pass. I think it's important to note

22 particularly with respect to various
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1 anniversaries coming up right now that these

2 are bigger questions, they have more global

3 implications and we should recognize that. 

4 That's all.

5 MR. FELDMAN: Jennifer?

6 MS. TAYLOR: I'm wondering, Zea

7 and Jay, if in your review of the literature

8 were you able to determine if the letters that

9 were coming from representative countries in

10 South America, if they were aware of the

11 health risk to the users.

12 MR. FELDMAN: You know, they saw

13 the same public documents that we see here so

14 we're assuming they were aware of the

15 literature which was cited in the document

16 that we put in the Federal Register, or

17 published. But I didn't see any comment on

18 the health effects.

19 MS. SONNABEND: Well, yes. All of

20 the commenters said we have not seen any

21 health effects from it. But that, I believe

22 we'll have at least one commenter on this and
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1 maybe it's a good question to ask them.

2 MR. FELDMAN: Nick was just saying

3 we're talking about a chronic, long-term

4 effect.

5 John is raising really important

6 points I think that really serve as the basis

7 for a larger discussion especially as we all

8 recognize we live in a global economy. And of

9 course we know that the program is constantly

10 dealing with international agreements and

11 trying to create uniformity across those

12 agreements. 

13 We, you know, I hope we have an

14 opportunity to explore the issues you've

15 raised in more depth when we have more time. 

16 But bioplastics is awaiting, so. Any other

17 discussion? Yes.

18 MR. STONE: I just want to make

19 sure kind of along that line of importance

20 that John raised that we sort of arbitrarily

21 picked 3 years because it's a year after

22 rulemaking. But if the industry is having
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1 trouble with alternatives that they have time

2 to adapt and it doesn't arbitrarily pull the

3 rug a little quicker than they can adapt.

4 MR. FELDMAN: Are you suggesting

5 another time frame? We can ask the

6 representatives. Yes, great. Thank you. Any

7 other questions? Okay. 

8 Sulfuric acid is up next. John is

9 managing this and we'll hear from Lisa first

10 on the petition. Thank you. 

11 MS. BRINES: Thanks, Jay. This

12 petition for sulfuric acid was received on

13 March 27, 2012 and was submitted by BioStar

14 Systems, LLC. The petition requests the

15 addition of sulfuric acid to Section 205.601

16 of the National List for use as a pH adjuster

17 for anaerobically digested poultry manure. 

18 In support of its review the Crops

19 Subcommittee utilized a technical report that

20 was developed in 2006 in response to another

21 petition for sulfuric acid for crop use that

22 was submitted in 2005. So there was no new
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1 technical report that was developed in

2 response to this petition.

3 Both the petition and the 2006

4 technical report were posted on the NOP

5 website in advance of the opening of the

6 public comment period for this meeting. 

7 Thanks.

8 MR. FELDMAN: Thank you, Lisa. 

9 John?

10 MR. FOSTER: Thank you. So, I'll

11 move as quickly as I can on this. The

12 discussion focused around the petitioners

13 asking that this is kind of the only hurdle

14 that's left to be cleared in order to use it. 

15 OMRI and others have limited the use of this

16 material in the context of poultry manure

17 stabilization. 

18 This is, as most of you know

19 there's an allowance for use with fish-based

20 products. So there's some parity questions

21 here, why would it be good for one versus --

22 and not for another. That was part of the
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1 discussion.

2 There's also -- the claim was that

3 other acids, while other acids can be used the

4 claim was that that was insufficient to get

5 the pH to where it needed to be to create a

6 marketable, a commercially viable shelf-stable

7 product. 

8 And let's see. Crops Subcommittee

9 agreed with the 2006 vote as Melissa described

10 because of various adverse environmental and

11 health impacts, lack of essentiality and

12 incompatibility with organic principles. The

13 vote was unanimous, 6-0, 2 absent, that it was

14 synthetic and that the listing motion was not

15 adopted by a vote of 6 against and 2 absent.

16 My count was five public comments

17 were submitted on this. I should say five

18 specific comments that were about sulfuric

19 acid in this petition specifically. There

20 were other general comments that could be

21 interpreted to apply, as in keep synthetics

22 out of organic, kind of that vein. 
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1 But five specifics. Four were

2 from individuals, one was from an

3 environmental organization. And the claims

4 were along the lines I mentioned earlier,

5 essentiality, compatibility and concern about

6 environmental consequences.

7 I have some comments outside of

8 that encapsulation that I throw in whenever

9 it's appropriate. 

10 MR. FELDMAN: Thank you, John. So

11 John, I'll call on you for starting the

12 discussion.

13 MR. FOSTER: Thank you. So this

14 is very interesting to me. I'm a big fan of

15 parity. I'm okay with this material in this

16 context. I'll be voting for it for a number

17 of reasons, but among them are ones that

18 didn't come up in the discussion that I wasn't

19 able to participate in some of those, but that

20 my experience particularly over the last year

21 with respect to farm inputs is that my -- on

22 commercial scale organic production there's
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1 starting to be a constriction of what organic

2 producers used to be able to use irrespective

3 of what conventional ag was using. 

4 And that in my experience started

5 to turn pretty dramatically about a year ago. 

6 And that was when I noticed that the supply of

7 compost that was compliant and able to be used

8 in organic ag started being used in very large

9 volumes by conventional vegetable and row crop

10 producers, particularly in southern California

11 and Arizona. 

12 And some of the growers that we

13 work with were starting to report significant

14 problems in getting enough compost. And like,

15 that's a great problem to have, right? But

16 still it's not -- I don't want to make it

17 sound like it's the end of the world because

18 it's not, but I do want to be mindful that as

19 organic grows, as conventional production

20 systems evolve, adopt more what we would call

21 organic practices there's going to be a point

22 where organic producers are competing for the
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1 same inputs as conventional. We're not used

2 to thing about that and I think we should get

3 ready for that.

4 This is one of the areas where I

5 think there's, for now there's a waste

6 product, poultry manure. If there's a way to

7 utilize that more fully, keep it out of places

8 it shouldn't be, I think that has

9 environmental benefits. If this is a

10 processing aid that helps that happen on the

11 whole I think that's a positive thing.

12 Yes, I'll leave it there. Thanks.

13 MR. FELDMAN: Thank you. Any

14 other questions or comments? Okay, thank you. 

15 We'll move onto the next item which is the

16 proposed biodegradable mulch film from

17 bioplastics petition. And Lisa will cue us

18 up. Thank you. 

19 MS. BRINES: Thanks, Jay. This

20 petition was received originally on January

21 20, 2012 and there was an update to the

22 petition that was submitted on March 26th. 
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1 The petition was submitted by the

2 Biodegradable Products Institute and it

3 requests the addition of biodegradable mulch

4 film made from bioplastics to Section 205.601

5 of the National List for use as a

6 biodegradable mulch. Related listings for

7 mulch on the National List appear at

8 205.601(b).

9 In support of its review the Crops

10 Subcommittee requested the development of a

11 technical report for this material. Both the

12 technical report and the revised petition were

13 posted on the NOP website and available to the

14 public in advance of the opening of the public

15 comment period.

16 And a representative of the

17 petitioner is signed up for in-person public

18 comment for later this afternoon. Thanks.

19 MR. FELDMAN: Thank you, Lisa. 

20 And we're very grateful to Carmela for

21 shepherding through this process with Zea. So

22 I'll turn it over to you, Carmela. Thanks.
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1 MS. BECK: All right. So Zea and

2 I are going to be tag-teaming on this

3 presentation the entire time. So, all right.

4 All right. So biodegradable mulch

5 film made from bioplastics is petitioned to

6 Section 205.601 of the National List for use

7 in organic crop production. This is an

8 alternative to petroleum-based plastic mulches

9 that do not biodegrade. And the byproducts of

10 completely biodegraded bioplastics are carbon

11 dioxide, water and soil biomass.

12 Here's the public -- so, here's

13 the summary of the public comment. The total

14 in favor of adding biodegradable mulch film is

15 163. Of that 163, 38 were farmers, 114 were

16 consumers and 11 were organizations. The

17 total number of those opposed to listing

18 biodegradable mulch film were four. They were

19 zero farmers, one consumer and three

20 organizations. There were also three

21 organizations that were requesting

22 clarification, annotation changes or further
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1 research. 

2 I'm going to go ahead and read

3 this whole annotation so bear with me. So,

4 the list on 205.601(b)(2). Okay. 

5 Biodegradable bio-based bioplastic mulch

6 meeting the following criteria: completely

7 biodegradable as shown by, 1) meeting the

8 requirements of ASTM Standard D6400 or D6868

9 specifications or of other international

10 standard specifications with essentially

11 identical criteria, that is to say, EN 13432,

12 EN 14995, ISO 17088; and 2) showing at least

13 90 percent biodegradation absolute or relative

14 to microcrystalline cellulose in less than 2

15 years in soil, tested according to ISO 17556

16 or ASTM 5988; (b) bio-based certified using

17 the ASTM D6866 method; (c) must be produced

18 without excluded methods; (d) must be produced

19 without engineered nanomaterials; and (e)

20 grower must take the appropriate actions to

21 ensure complete degradation at the end of each

22 growing or harvest season. So that's our
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1 current Crops Subcommittee recommended

2 annotation.

3 So the next seven slides are

4 actually just going to be each of the seven

5 sections within the annotation. We listed the

6 public comments there and I'll just comment on

7 one or two of them. You all can read the

8 rest.

9 So with regards to the name, BPI

10 has requested the following name change to

11 biodegradable mulch film. Section A thought

12 it was important to point out OMRI's comments

13 where they state that meeting the requirements

14 of ASTM versus bio-based certified using ASTM

15 mean two different things. 

16 OMRI interpreted A(1) to mean that

17 the product must meet the requirements of the

18 specific standard but not necessarily be

19 independently certified to those standards. 

20 If it is the NOSB intent to require a

21 certification to each cited method the

22 language should read "certified to ASTM
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1 standard." 

2 Let's see. They also stated that

3 they felt that the ASTM reference in A(2) is

4 more applicable in comparison to the ASTM

5 standard references in this section. Other

6 commenters, several commenters suggested that

7 there were way too many standards cited in our

8 annotation.

9 So in A(2) BPI made a

10 clarification and said that the terms

11 "biodegradation" and "mineralization" are

12 different. As you can see it says the 90

13 percent threshold value required by the

14 petition and ASTM test methods refer to

15 mineralization. So a complete biodegradation

16 is inferred when a mineralization level of 90

17 percent is reached.

18 OMRI points out that 5988 is a

19 testing method rather than a standard to which

20 certification can be obtained. PCO stated

21 that there again are too many standards

22 referenced in the annotation.
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1 In Section B CFS points out that

2 the ASTM standards are based on laboratory

3 testing protocols and they're not field

4 tested. OMRI points out that ASTM 6866 is a

5 testing method and it's not a certification.

6 Section C. CCOF provided the

7 suggested change to this annotation. They

8 said that "must be produced without organisms

9 derived from excluded methods." Other

10 commenters wanted to -- stated that the

11 feedstock and microbial fermentation processes

12 should both be free from GE products. 

13 The OTA said that in general

14 there's a prohibition on excluded methods and

15 they express concern over this general

16 prohibition in a specific annotation and they

17 wanted to know what the opinion of the program

18 was with regards to this inclusion.

19 D, both OMRI and OTA expressed

20 concern over the lack of a legal definition of

21 "engineered nanomaterials." And the OTA again

22 wanted to know what the opinion of the NOP was
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1 with regards to including this in the

2 annotation.

3 Section E. Both BPI and CCOF

4 offered alternatives or additions to this

5 portion. BPI suggested that we put in there

6 "as recommended by the manufacturer." CCOF

7 included methods by which the biodegradation

8 would occur. 

9 CROPP asked what exactly were the

10 grower practices that would achieve the 2-year

11 biodegradability annotation. Organically

12 Grown asked for a definition of "complete

13 degradation." So did PCO, and PCO also

14 specified that we shouldn't be able to use the

15 2 years consecutively in the same field.

16 MS. SONNABEND: Okay. Just --

17 yes. These were additional concerns that were

18 raised by points that weren't exactly part of

19 our annotation. They have to do with short20 and long-term impact of pigments on the

21 ecosystem metal catalyst building up in the

22 soil, other additives and processing aids. 
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1 And then how will growers and certifiers know

2 when the mulch is completely degraded? And

3 then the comments, insufficient studies to

4 verify biodegradability and effect on the

5 environment. 

6 So before we get into how -- where

7 we're going with this I want to go back

8 through some of the slides to talk about how

9 we are digesting the information that has come

10 in and what our thinking is on this.

11 So starting back with slide 6. 

12 The questioning of why there are so many

13 standards referred to and in particular two

14 standards for ASTM. We have received

15 information about those standards that the

16 first of the ASTM standards is a high17 temperature standard in which conditions

18 similar to composting are being applied. 

19 The first test provides an initial

20 rejection point much earlier in the time line

21 of review of the material. The ASTM 6400

22 which is the first one talks about a few weeks
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1 of composting activity, but it also confirms

2 the absence of ecotoxic effect being via plant

3 growth and seedling germination tests in soils

4 treated with the mulch. 

5 The second test, the ASTM D6868,

6 measures biodegradation under lower

7 temperature conditions. The film would have

8 to meet both specifications of higher and

9 lower temp degradation to be considered

10 appropriate.

11 Now, we recognized at the outset

12 of public comment that we were trying to do

13 two things with our annotation. One is to

14 make an annotation so that reviewers can

15 review products that they would be suitable to

16 biodegrade enough, and the reviewers being

17 MROs and certifiers who do materials review.

18 And then the second part is what a

19 grower would have to do and a certifier would

20 have to do to comply -- to verify what the

21 grower was doing. So we are going to try and

22 separate those out in a revised annotation
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1 because going forward we don't want a grower

2 to think that they have to meet a 90 percent

3 breakdown compared to microcrystalline

4 cellulose, you know, that part. And if we can

5 go to the next slide.

6 This is designed for MROs who are

7 reviewing products, not for growers to have to

8 comply with. And so we will talk about this

9 going forward in the two different facets,

10 what an MRO/certifier reviewing the products

11 versus what a grower and certifier verifying

12 the product use has to do.

13 Okay. So -- okay. BPI explains

14 the 90 percent which we got questions of in

15 their comments, that there's a certain amount

16 of mineralization and the distinction between

17 mineralization and degradation is -- comes

18 into play.

19 There are also questions raised

20 about the need for certification for a

21 standard, these ASTM standards, which are only

22 standards but don't have a certification
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1 behind them. I think we will hear more about

2 this in the public comment coming up and so we

3 will defer talking about that exact point at

4 the moment.

5 The next slide. We realize that

6 we made incorrect terminology here and that

7 the ASTM D6866 is a testing protocol, not a

8 certification. 

9 BPI suggests bio-based content

10 will be determined and disclosed using the

11 ASTM method, but then we have to of course

12 have a way, either a certification or an

13 endpoint so that the MRO can determine what

14 amount of bio-based content is sufficient or

15 desirable in a product. Next slide.

16 Okay. So, our thinking on

17 excluded methods is this. We realize that

18 excluded methods is in the rule and is

19 supposed to apply to everything in the rule. 

20 However, the excluded methods in the rule

21 refers to field application of inputs and then

22 things in processed foods. 
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1 We've heard the reasoning already

2 from people that these mulches are not going

3 to be -- they maybe have genetically

4 engineered organisms used to make the mulch,

5 but those organisms are not released into the

6 field. They're in a building that they're

7 manufacturing it in and therefore the excluded

8 method wouldn't apply to this and genetically

9 engineered bacteria could be used to produce

10 this mulch.

11 We reject that contention and we

12 believe that we should do everything possible

13 to keep sources of GMOs out of our stream at

14 any point. And therefore we feel like

15 although it may seem redundant to some we need

16 to put it should not be used with organisms --

17 it should not be made from genetically

18 engineered bacteria or organisms.

19 The feedstock issue is more

20 complicated because right now there's nothing

21 in the rule or in most certifiers'

22 interpretation of it that would prevent you
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1 from going into your neighbor's GMO cornfield,

2 cutting down some corn stalks and bringing

3 them into your farm and mulching with them. 

4 There's no prohibition specifically on GMO

5 content of any soil inputs per se. And so

6 it's very -- there is a lack of a

7 comprehensive policy on this.

8 People have -- and when I say

9 "people" I mean certifiers and MROs primarily

10 have developed their own policies and they

11 differ somewhat. It's clearly on the work

12 plan for the GMO Ad Hoc Subcommittee to work

13 on making these policies more consistent and

14 to work on a structure and a protocol for

15 evaluating GMO inputs.

16 Therefore our inclination is to

17 not make a statement in this annotation about

18 the feedstock with the acknowledge that we

19 don't like GMOs and we want to keep them out

20 of our chain, but we'd rather have a

21 comprehensive policy that addresses all the

22 GMOs and all the inputs if possible at some
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1 point in the future, and possibly within the

2 2 years that it takes for this rule to be --

3 which it's likely to take for this rule to

4 come out.

5 We are still -- we don't have a --

6 none of these points I am discussing have been

7 voted by our subcommittee yet but I'm just

8 telling you what our discussion points are and

9 I'm sure you can help address them in

10 comments. 

11 As far as the nanomaterials, we

12 were -- we totally agree that nanomaterials do

13 not belong in organics in any way. And the

14 question becomes whether we need to say this

15 again or whether it's sufficient in the

16 annotation -- to not have it in the annotation

17 but to be clear from the existing NOSB

18 recommendation with NOP affirmation of it that

19 they would be out anyway.

20 We did hear quite a bit of

21 comments, especially from the people in the

22 field who have to deal with enforcing the
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1 annotation that shorter is better for our

2 annotation. And so we are -- we're thinking

3 that we maybe do not need this clause to go

4 forward.

5 And then lastly, the grower must

6 take appropriate actions. We acknowledge the

7 comment that it's too confusing to put growing

8 season or harvest season language in that but

9 we feel very strongly that this is the main

10 clause that affects growers and that those

11 appropriate actions are still being determined

12 through research on the material. 

13 The appropriate actions would be

14 things like proper soil incorporation, enough

15 moisture, enough sunlight and like that. But

16 if we make the annotation a lot longer by

17 including it we're not going to cover

18 everything and we're not going to give clear

19 guideline for certifiers of how to assess that

20 those appropriate actions are being followed. 

21 So we've discussed with the

22 Department about this and they concur that
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1 while the rulemaking process is going on if we

2 just leave it at appropriate actions we can

3 then develop a guidance that the NOSB will

4 recommend for and the NOP will cooperate with

5 on exactly what those appropriate actions are,

6 what conditions the mulch may or may not be

7 appropriate from because we think there may be

8 some environmental conditions, soil conditions

9 and the like that these mulches have not been

10 shown to break down properly and the research

11 is still ongoing. 

12 But it would enable us to put all

13 that in guidance along with what a certifier

14 would do to verify that the mulch was

15 completely broken down or that the appropriate

16 actions were being taken. That's it. Oh

17 wait, no, one more slide. Sorry.

18 The additional concerns slide to

19 the chart because we don't want to leave

20 without addressing the additional concerns. 

21 Okay, the short- and long-term impact of

22 additives. The only additives that are being
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1 clearly added in the TR and especially

2 pigments or titanium dioxide in carbon black.

3 Titanium dioxide is non-synthetic

4 and would be allowed anyway, and carbon black

5 is pure carbon. And although it's synthetic

6 it's in effect already allowed as the main

7 component of the ink in newspaper mulch. Any

8 other pigments would have to be petitioned in

9 the future because this is what is in the TR

10 that we're dealing with right now.

11 As far as the other components an

12 important part of meeting the ASTM 6400

13 standard above is to verify that any

14 substances break down completely along with

15 the other ingredients, and those additives

16 will be tested in the course of complying with

17 a standard, either by the MRO or the

18 manufacturer of the materials. 

19 I should add that very recently we

20 were given research out of Europe which

21 they've done considerably more research than

22 we have where they've tested for ecotoxicity
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1 of all the possible chemicals after several

2 years of using the material and no ecotoxic

3 residues were found of anything.

4 Okay, the processing aids are the

5 same comment as above. The one manufacturer

6 of PLA bioplastic stated that the TR was

7 inaccurate in what solvents they used and they

8 do not use any solvents to produce PLA.

9 How do we know if the mulch is

10 degraded will be covered in the guidance. And

11 insufficient studies to verify

12 biodegradability. Well, there can always be

13 more studies, we know that. We know that it's

14 a relatively new product in the scheme of

15 things and we are to some extent taking a

16 risk.

17 We feel that we have roughly a 2-

18 year window because the NOP has to -- in the

19 rulemaking process has to address the clauses

20 in I think it's 205.206 about removing mulch

21 and so it will probably take a little longer

22 than your average thing.
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1 If any problems emerge during that

2 period we will reserve the right to take it up

3 again and reconsider, but we feel that getting

4 the process started because not only will

5 there be at least the 2-year rulemaking

6 process but then the people who are already

7 using it will have used a prohibited material

8 and may have to wait 3 years to get

9 certification back. And so we feel that we'd

10 like to get started with this now and that we

11 can write a good annotation that will satisfy

12 most of the concerns of the whole organic

13 community. Thank you.

14 MR. FELDMAN: Thank you. We are

15 now at 11 o'clock. We started this session 10

16 minutes late so I defer to the chair as to how

17 we should proceed. Our next segment of this

18 session starts at 11 o'clock. So if we could

19 steal a little more time, ask if there are any

20 questions that would be my preference and then

21 move on from there. Okay, just 5 or 10

22 minutes. Any questions from the board on
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1 this?

2 Just so you all know, our thinking

3 right now as a committee is that we would hold

4 this over till Thursday to have a vote. So

5 don't feel too much pressure but feel some

6 pressure. Go ahead, John.

7 MR. FOSTER: Thank you. So, no

8 surprise to anyone on the board. So I've kind

9 of evolved my position a little bit on the

10 ASTM. We had a pretty good discussion in

11 previous sessions on that so I've evolved

12 around a little. I can get my head around the

13 ASTM thing now better.

14 So, but I think more precautionary

15 just that every annotation makes a material

16 that much harder to employ. And while in

17 general I think that can be a fine thing if it

18 serves to get in the way of utilizing a better

19 material which I think this, you know,

20 bioplastics, biofilms, I'm not quite sure

21 where we're going to settle on the name but

22 this stuff seems like it's better than the
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1 current stuff. 

2 And I really don't want to see

3 annotations get in the way or provide any

4 degree of disincentive to a grower

5 particularly to make something better. It's

6 not perfect, we do -- I hate to break it to

7 everyone, but we're not living in a perfect

8 world. We're just trying to make it a little

9 better, at least that's my approach. I think

10 this is an opportunity to do that.

11 I'd like to provide as many

12 incentives as possible to make it

13 incrementally better. I think that's about

14 all we can hope for and I want to throw it out

15 there. I know you're used to hearing it from

16 me so I'll just stop there. That's my main

17 point.

18 MR. FELDMAN: Any other comments? 

19 Mac.

20 MR. STONE: In conversation it was

21 discussed is this a plastic or does it fit the

22 definition of plastic? Are we going to hear
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1 from commenters, or is this a starch film? 

2 And does that have sort of a trickle-down and

3 not go viral in the rulemaking process by

4 semantics?

5 MR. FELDMAN: So that's a question

6 we want to pose to folks in the comment

7 period. Any other comments? Colehour.

8 MR. BONDERA: Thank you and thank

9 you, Zea and Carmela, for the presentation. 

10 I want to just let people know

11 that I actually, if you look at the record I

12 actually abstained from the listing motion on

13 this in the Crops Subcommittee because the

14 truth is that from my perspective at that

15 point in time there were lots of unclear and

16 unanswered questions. And I think like John

17 suggested it's not a perfect world but for me

18 when I don't know then I get concerned. 

19 I wanted to just say that as an

20 introduction because I did while this

21 presentation was happening write down some

22 questions and I want to ask at least one of
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1 them back to you, Zea, to sort of go on a

2 little bit more about. Maybe we can ask some

3 people when they're testifying this same

4 question. 

5 But it's a little bit confusing to

6 me from listening to people. If this product

7 is tilled in in the field then doesn't that

8 make it a field application? And it's not

9 removable? And so I just -- that line between

10 whether or not it's a field application and

11 this issue related to the word plastic and how

12 it fits into regulation is confusing to me.

13 But if the recommended or the

14 actual use includes tilling the product in

15 then that becomes a field application. And so

16 if we're going to refer to field application

17 then I wonder if you can clarify or address

18 that a little bit. Thank you.

19 MS. SONNABEND: Yes, it is tilled

20 in and it is a field application.

21 MR. FELDMAN: Other questions that

22 you want to raise now? Okay. Then with that,
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1 Mr. Chairman, I guess we're moving onto the

2 next session which is still under the Crops

3 Committee so should we just segue way to that

4 right now? Okay.

5 Thank you all for moving through

6 this so quickly. We really appreciate it. 

7 Really good job helping us move this along. 

8 And with that we close this, the review of

9 proposals and petitions and so forth.

10 And now we're moving into the 11

11 o'clock session where we will do three things. 

12 We will update the board from the Tree Fruit

13 Working Group with David Granatstein. We've

14 allocated 25 minutes to that including Q&A. 

15 And then we'll hear from Urvashi Rangan with

16 Consumers Union, 25 minutes including Q&A,

17 again on issues related to tetracycline and

18 streptomycin. And then end with Kiki Hubbard

19 from the Organic Seed Alliance, 25 minutes

20 with Q&A. So we have a full hour and 15

21 minutes until lunch. And why don't we call

22 Dr. Granatstein up to the podium for his
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1 presentation and begin this session.

2 I'd like to welcome you. Thank

3 you for coming. I'm going to do a little bit

4 of an introduction so folks have background. 

5 I know many folks in the room already know you

6 and appreciate your long career and

7 contribution to organic production.

8 David Granatstein is sustainable

9 agriculture specialist with Washington State

10 University's Center for Sustaining Agriculture

11 and Natural Resources. He has worked with

12 organic farming since 1975 in many different

13 capacities and provides significant support

14 for the organic tree fruit sector in

15 Washington State.

16 He serves on the state organic

17 advisory board and on the board of directors

18 of Oregon Tilth and is chair of the

19 International Society for Horticultural

20 Science Organic Fruit Tree Group. David is

21 based in Wenatchee, Washington. 

22 Welcome, Dr. Granatstein. Thank
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1 you so much for coming.

2 DR. GRANATSTEIN: Thank you, Jay,

3 and thank you to the entire board for asking

4 for this update. 

5 So I'm going to start out just

6 with a little bit of context for those on the

7 board that aren't familiar with the history of

8 our group. This group came about after the

9 Seattle meeting a year and a half ago where

10 the issue of antibiotics and fire blight was

11 discussed. 

12 And the general call was put out

13 can we form a group to kind of find out where

14 we are in terms of progress on this issue, on

15 alternatives, on the needs of the industry, et

16 cetera. 

17 So we put a group together with

18 our purpose being broader than just looking at

19 the single issue of antibiotics and fire

20 blight, anticipating there are going to be

21 issues for tree fruit into the future. And we

22 wanted a group of folks ready to address those
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1 and work with the NOSB in terms of providing

2 the best possible information. 

3 So our goal is to create the

4 healthiest, most sustainable organic tree

5 fruit system. That's really what our group is

6 attempting to do. To do this by communicating

7 science-based information and grower

8 experience to you, the NOSB, and help inform

9 deliberations that go on here.

10 Our group has about 17 people from

11 a range of different backgrounds and different

12 parts of the country. We are an industry

13 group representing more the growing and

14 handling side, not a group that includes all

15 stakeholders. So that's one thing I want to

16 make clear. 

17 So to start out I just wanted to

18 show where we are in terms of organic tree

19 fruit. It is still growing. These data are

20 some that we've been tracking now for a number

21 of years. And you can see the growth from

22 2010 to `11 we had 6 percent increase in sales
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1 of organic apples at this point in the growing

2 season, 8 percent for pears. In this next

3 year, 11 to 12, 27 percent increase and 43

4 percent for pears. So dramatic increase in

5 the growth of sales which says consumers want

6 these products and they want them even more

7 than they did a year ago. So that is an

8 indication of consumer demand.

9 We also can see here in the graph,

10 the blue line represents the price for organic

11 gala apples. The red line is conventional

12 gala apples. And therefore the market has

13 provided a consistent premium price for

14 organic growers over the long haul.

15 Fire blight is kind of the disease

16 of concern here. That's why people are using

17 antibiotics when they do. It's a very

18 complicated disease. I'm not going to go into

19 it. We did talk about this a year ago when I

20 did my previous presentation, but probably the

21 main point is that fire blight control depends

22 on prevention, not cure. And so everything
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1 we're talking about is how to prevent

2 infection. Once trees are infected the only

3 cure is the chainsaw essentially, cutting out

4 limbs or cutting down trees and burning the

5 material. So that's what we're talking about

6 here. Antibiotic use is not a curative like

7 it is when we use it for medical reasons. 

8 It's a very different situation.

9 Growers use a range of management

10 practices for fire blight. This is a list of

11 many of them. We start with genetic tolerance

12 but this is limited in terms of what varieties

13 of apples and pears are commercially viable. 

14 So we have partly a discussion around scale. 

15 Small growers have a much larger range of

16 materials to choose from. They can develop

17 relationships with their consumers who will

18 accept the certain characteristics of those

19 fruit that may or may not store very well, may

20 not ship well, may not hold up in a retail

21 environment. But for larger growers those are

22 key considerations as to which varieties they
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1 can use.

2 We've talked about the Geneva root

3 stocks and I'll mention those in a minute. 

4 There is good progress happening there. But

5 bottom line, when it comes down to a risk of

6 infection as determined by the weather

7 conditions, driven by the computer models that

8 growers use, growers will turn to a material

9 to intervene and try to prevent infection. 

10 And to give some perspective on

11 current use, from 2001 to 2011 the percent of

12 bearing acres treated by antibiotics in the

13 U.S. for apples, for tetracycline it was 9.7

14 percent, about 10 percent in a given year were

15 treated, for streptomycin about 17 percent. 

16 When we look at pears it's about 34 percent

17 for tetracycline and 28 percent for strep. 

18 So right away you see those two

19 crops have different intensity of use factors. 

20 Pears tend to be more susceptible and are

21 treated on average more often.

22 We can also look at plant use of
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1 antibiotics relative to, for example, use in

2 animal agriculture. And the EPA has

3 determined that a typical pharmaceutical use

4 of tetracycline, when we take it to control an

5 infection in our body, that exposure is 50,000

6 to 200,000 times greater than the maximum

7 theoretical dietary exposure from use of

8 antibiotics in plant agriculture. Just to put

9 things in some perspective.

10 So really the crux of our

11 discussion is around what are the

12 alternatives, how are we progressing. We've

13 heard about Blossom Protect. That's a new

14 material that was registered in early 2012 so

15 it was the first chance for growers to

16 actually use it on a commercial scale. 

17 This is a product interestingly

18 enough that was originally isolated in

19 Wenatchee where I live by a USDA researcher,

20 picked up by some Germans, used for another

21 purpose first and then applied as a potential

22 control for fire blight. And it is looking
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1 very promising. But again, 2012, the first

2 year for growers to use it and there was

3 limited amount of material available, about

4 enough for 2,000 acres.

5 Two thousand and twelve was a

6 severe fire blight year in Washington State,

7 very, very severe. And it was a very odd year

8 in that the bloom period when we're treating

9 for this disease was extremely compressed. So

10 while the grower reports of efficacy are

11 generally positive there were issues around

12 timing, how to integrate the use of that

13 material with the other activity going on then

14 which is thinning of the blossoms to control

15 the crop load. So this is one area where we

16 clearly need some more work such that the

17 growers have good guidance on how to integrate

18 this new product into an overall management

19 program.

20 The material is only registered

21 for use on bloom so it will not be allowable

22 during other times of the year such as the
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1 summer if there's a hailstorm. And certainly

2 in the Midwest and the Eastern states often

3 this is a bigger issue for fire blight

4 infection than bloom time. In the Pacific

5 Northwest our primary concern is during the

6 bloom. So different regions are going to

7 experience different possibilities with this

8 particular material.

9 There's some new materials being

10 developed, some copper materials that are more

11 active than current materials, probably will

12 allow lower rates of actual copper to be used

13 which is good because there are long-term

14 concerns about buildup in the soil. These

15 aren't registered yet and it's not clear if

16 they will be submitted for OMRI or other

17 material review approval. But they are in the

18 pipeline and they are showing good efficacy.

19 And then finally there's work

20 going on with integrated control. So rather

21 than just replacing an antibiotic with one

22 material that's expected to substitute for it
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1 how do we start to mix and match the different

2 options that are out there? Some work better

3 on a certain part of the flower, the stigma

4 versus the nectarie. Getting an understanding

5 of that, the sequencing of these materials,

6 integrating with thinning programs. Many of

7 the thinning materials are toxic to these

8 biological control agents so we're still in

9 the process of trying to put all that

10 together. But that is the type of research

11 that is underway.

12 So here's a quick example of some

13 of the work that's been going on. These are

14 2012 results similar to results from the past

15 several years showing on the top bar

16 streptomycin typically is our standard against

17 which we measure the efficacy of other

18 controls. In the green bars we see -- the

19 green bars are the Blossom Protect. So not

20 quite as good as the streptomycin but right up

21 there in terms of very good efficacy. Some of

22 the new copper materials are next in the blue
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1 bar. So the data have been pretty consistent

2 showing that these are performing well over

3 different years.

4 These results come from Ken

5 Johnson and the OREI-funded project. This

6 project was started, the first field season in

7 2012, and will run through 2016. And of

8 course this is just a really great addition to

9 our ability to transition from the use of

10 antibiotics. So again, they're testing

11 different materials and a lot of testing of

12 different combinations of materials to see how

13 they hold up over time. 

14 In this case, again, streptomycin

15 down here is sort of the standard and we see

16 the lime sulfur plus fish oil. That's a

17 standard thinning program that also has

18 activity against the fire blight bacteria

19 followed by the Blossom Protect is doing as

20 well as the streptomycin. So this has been a

21 result that's been pretty consistent as shown

22 here by Ken Johnson.
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1 These are data from three

2 different growing seasons now in Corvallis,

3 Oregon, western Oregon. And the yellow bar

4 with the star represents that treatment of the

5 organic thinning sprays followed by the

6 Blossom Protect and they are doing as well as

7 those treatments with antibiotics. 

8 So again we're starting to see

9 some consistency in the efficacy of use here. 

10 But these are all inoculated trials, these are

11 all researcher trials. These aren't yet the

12 large-scale field trials where growers are

13 using these out in the real world, and that's

14 one of the gaps I think that we still face.

15 Another example of work from the

16 OREI project. This comes from California,

17 northern California where they're looking at

18 the use of coppers pre-bloom to try to knock

19 down the inoculum level of fire blight in the

20 orchards. And in this case they were just

21 comparing the use of oil which is a standard

22 delayed dormant treatment for a number of
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1 insects and some diseases to the copper plus

2 the oil. So the gap between them is the

3 reduction in fire blight by the addition of

4 copper. So, again, very promising

5 developments there.

6 And this is being accompanied with

7 some new work called LAMP. LAMP is a

8 detection technology using molecular methods

9 to actually be able to go out, sample blossoms

10 from the orchard and see how much fire blight

11 exists and when does it exist, when does it

12 start building up. 

13 Because it may be that the fire

14 blight model says you are in a high-infection

15 period. At this point in time a grower would

16 respond by treating with an antibiotic, with

17 a biological, whatever material they were

18 using. But it could be that there's not

19 enough organisms in the orchard to even

20 warrant that. And we have yet to have a good

21 diagnostic test that a grower can use in that

22 kind of realtime fashion. This LAMP
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1 technology is being developed, is coming along

2 and I think will be a very, very important

3 complement to a non-antibiotic and a more

4 precise fire blight management program in

5 general. So that is also part of the OREI

6 project that's underway.

7 We've talked a lot in the past

8 about genetic resistance and how this should

9 really be our first line of defense and some

10 of the struggles of working with this. 

11 So, I just completed a survey, I

12 did a phone survey of a number of the major

13 fruit tree-producing nurseries to find out

14 where they are at. And the first question was

15 around the Geneva root stocks. That's

16 something we've talked about before. Those

17 are moving along but if I wanted to order

18 trees today on Geneva root stock it would be

19 4 to 5 years until I could get those trees. 

20 That's how far the backlog is, that's how slow

21 the reproduction of that clonal material is. 

22 They are optimistic that it's going to improve
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1 but it's still quite a ways out if I wanted to

2 start today.

3 And we would compare that to my

4 ordering trees on the M.9 root stock which is

5 highly susceptible to fire blight, 2-year

6 turnaround, no problem. So there's still a

7 bit of a gap between what growers can get

8 through the standard channels versus the

9 Geneva root stocks. But they are looking very

10 promising as far as their fire blight

11 resistance.

12 And in fact, it does appear from

13 some current research, some very recent

14 research that the Geneva root stock helps the

15 scion that's grafted on top of it to resist

16 the spread of infection a bit more than had

17 been anticipated. So it doesn't slow the

18 infection or reduce the infectability, but if

19 a tree does get infected it appears that

20 there's some nutrient interactions with the

21 root stock that make the infection less

22 damaging. And that's brand new information
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1 from Gennaro Fazio in Geneva, New York.

2 Resistant cultivars. All the

3 nurseries I talked to, no one could say ah,

4 there's a fire blight-resistant apple coming

5 down the line that's got real promise. Not

6 one could tell me that. Same for pears. So

7 we're still in that dilemma of things being

8 driven by the commercialization

9 characteristics and the breeding specifically

10 for fire blight still is lagging behind.

11 One example of some promise though

12 is a pear that's being tested at Hood River,

13 Oregon. This is a selection done by USDA

14 that's been tested there now for 10 years that

15 still has not been released, so it's not a

16 named variety yet. It probably will be within

17 the next year. And at that point they plan to

18 plant about a six-tenths of an acre

19 demonstration in Hood River at Oregon State

20 University to begin the whole process of

21 grower evaluation. They need enough fruit for

22 the growers to see how it will work, for the
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1 packing houses to test how it's going to

2 handle and store, and for consumers to get

3 used to it. And that's at least another 5-

4 year process. So that gives you a feeling for

5 the time frame of actually getting these

6 materials out there once they're proven to

7 have some value for resistance.

8 There's a new project in

9 Washington and with ARS specifically taking

10 traits from another apple species, malus

11 sieversii. This is a wild relative of apple

12 but it's the strain or it's the species that

13 has the more desirable fruit characteristics. 

14 Many of the past efforts for fire blight

15 breeding used different malus species for

16 which the fruit quality never transferred

17 across to varieties that were going to be

18 acceptable to consumers. 

19 So they're going to try to bring

20 those genes into the crop reference set that

21 they've developed and using marker-assisted

22 breeding start to understand where they're
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1 getting the fire blight resistance. And it

2 looks like there's at least five different

3 locations of fire blight resistance. It's not

4 a single gene or single cluster kind of

5 relationship. So fairly complicated but

6 that's a very promising project that's just

7 starting.

8 And then there's been some new

9 field screening, unpublished data so far by

10 Gennaro Fazio and colleagues looking at some

11 of our modern varieties and trying to see

12 where we are. Again, these weren't bred for

13 fire blight resistance but the question is do

14 they have any. And here's our Geneva root

15 stock G.41, zero infection compared to M.9

16 right below it, up to 100 percent infection. 

17 So clearly the Geneva series are progress.

18 Then here's another example of a

19 scion. This is a Sonya apple out of New

20 Zealand. I called the North American nursery

21 that's producing this. They had no idea it

22 had any fire blight resistance. So again, it
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1 wasn't bred for that, it really wasn't

2 actively screened for it, but it turns out

3 that it actually may have some very good

4 resistance. Unfortunately this is a patented

5 club variety and it's currently restricted to

6 400 acres of planting in the U.S.A. So it's

7 not a panacea, not -- most people will not be

8 able to grow this. So those are some of the

9 dilemmas around utilizing genetic resistance.

10 Extension activities, there have

11 been a number of things done over this past

12 year. Probably the most exciting was an e13 organic webinar done nationally by Ken Johnson

14 on antibiotic control. And some 250 people

15 attended that webinar. 

16 But what they're finding with

17 these e-organic webinars, because they post

18 them online many more people come after the

19 fact. So I don't know, it's probably up to

20 thousands of people have been utilizing this

21 information. So a very, very powerful way to

22 get the information out there.
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1 I've continued with my surveys of

2 organic tree fruit growers in Washington to

3 try to get a sense of what they think they'll

4 do as the rule change comes into effect. So

5 now this is the third year we've asked them

6 these questions. 

7 How will the loss of antibiotics

8 for fire blight control impact your operation? 

9 And what we've seen is a shift where we had

10 more people in the little to no effect, that's

11 the most lefthand bar. That used to be 10,

12 12, 15 percent. Now it's down to 7 percent so

13 people's concern level is rising. And nearly

14 90 percent are saying it's going to impact my

15 production or maybe even force me to exit

16 organic apple or pear production. So that's

17 from Washington State growers. 

18 A colleague on our committee

19 surveyed some of his folks in the Northeast,

20 small organic growers. They had the opposite. 

21 They said in general it probably won't change

22 what we do very much. So it's going to be a
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1 different reaction depending on the part of

2 the country you're in and the size of your

3 operation.

4 We also asked them if you tried a

5 non-antibiotic control regime and

6 interestingly enough 73 percent had tried it. 

7 That surprised me. We then asked them if it

8 was successful. Thirty-three percent said

9 yes, 67 percent said no. But this was prior

10 to people being able to use the Blossom

11 Protect product that came out this year. So

12 it will be interesting to see if after this

13 year that answer might change.

14 And then we asked them flat out do

15 you support extending the phase-out date and

16 93 percent said yes. 

17 So as far as next steps, the

18 feeling that our group has is to develop a

19 rational plan for phase-out. Our group

20 totally supports phase-out. Our growers

21 understand that phase-out is the future, let's

22 get ready for it. But they feel they do need
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1 more time to minimize disruption to the

2 growers, to the actual volume of production

3 and to the market and the consumers who as you

4 saw really want these products. So we believe

5 consideration of an extended expiration date

6 does make a lot of sense.

7 In the meantime we're going to

8 have the continued testing. Let's let the

9 OREI project come to completion, that will be

10 2016. It should produce a wealth of

11 information. We've got to transfer that

12 research experience then to good extension

13 materials and good education with growers. 

14 The number one barrier right now

15 is confidence-building. Fire blight is a

16 very, very high-risk proposition and people

17 are not going to bet the farm on it without

18 knowing with a high level of certainty that

19 these alternatives will deliver under the

20 different conditions in different locations

21 that they're facing.

22 We will have new products like the
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1 copper is coming down the pike to help. More

2 testing of the integration is going to help

3 people figure out how to use these.

4 Some of the more novel research is

5 beyond the scope of the time frame we're

6 looking at but we believe that will help as

7 well into the future. And again, right now

8 you can't go and find a published extension

9 bulletin on science-based non-antibiotic fire

10 blight control and we need to get to that

11 point. That's what growers want to find for

12 their confidence-building. So we have more

13 information on the website that's listed there

14 and we'll plan to put more information online

15 as we get it. 

16 Probably one of the biggest things

17 to consider as I close here is that the reason

18 we in Washington have had so many people,

19 about 20-some percent of our growers in the

20 European Union program which does not allow

21 antibiotics is because if they hit a situation

22 where it's an extreme year and they are not
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1 comfortable with their control program they

2 can use antibiotics, leave the EU program, but

3 remain certified organic. And so the irony is

4 that the availability of the antibiotic

5 control is probably the reason we have such a

6 high number of people not using antibiotics. 

7 So, the risk factor is really huge in terms of

8 the growers and we've got to make sure that we

9 address that.

10 So at this point I'll close just

11 by saying we are working on some documents

12 looking at the published science on antibiotic

13 residues in tree fruit systems and the risk of

14 antibiotic resistance transferring to human

15 pathogens from use in tree fruit as well. 

16 With that I'll close and try to answer any

17 questions that I can.

18 MR. FELDMAN: Thank you very much. 

19 Questions from the board? Go ahead, Nick.

20 MR. MARAVELL: Yes, thank you for

21 an excellent presentation. I have two

22 questions and you don't have to answer both if
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1 we're short on time.

2 One question is is there

3 sufficient research taking place in the

4 various -- in your opinion is there sufficient

5 research taking place in the various regions

6 of the country so that we will be able to give

7 that level of confidence to growers Northeast,

8 Midwest, West.

9 And my second question so you can

10 judge your timing on the response is in your

11 research with the LAMP system where you're

12 taking measurements in specific site locations

13 for the presence of the fire blight is your

14 research built such that that will have a

15 feedback loop to your current predictive

16 models? Is it possible that you might

17 actually be modifying your predictive models

18 based on that data?

19 DR. GRANATSTEIN: First question,

20 the answer is no. Most of the research right

21 now, the OREI project is focused on Oregon,

22 Washington and California. That's what it was
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1 funded for. Some folks in Michigan did put in

2 a proposal to OREI to carry on some very

3 similar working the Midwest. That proposal

4 was not funded. So unfortunately that eastern

5 part of the country does not have the same

6 level of activity. 

7 I'm not sure how many people are

8 testing these materials. I know folks at

9 Michigan State were testing them on their own. 

10 I'm not sure how they were being funded but

11 they don't have a nice well thought through

12 and integrated project like we do in the West. 

13 So that is definitely a gap that's out there.

14 As far as the LAMP currently the

15 models are not based on, quote, "scouting"

16 because there hasn't been a technique. So

17 they would have to figure out how they'd build

18 that in there and I assume they would try to

19 do that. But to date that has not been part

20 of the package.

21 One thing that's been noticed on

22 the use of the models, the models were
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1 designed in many ways for growers to wait

2 until the last minute to act such that they

3 weren't using these materials in an

4 unwarranted situation based on essentially

5 weather conditions. 

6 But because the non-antibiotic

7 control regimes require more time for

8 everything to begin to work it's probably

9 going to be necessary to back off and act

10 earlier than growers now do, and therefore

11 more risk of acting when there was no need to

12 act based on the ultimate play-out of the

13 weather. So that's one of the challenges of

14 trying to figure out how to use the model with

15 these new tools and that was something people

16 found this year.

17 The real advantage to the LAMP

18 will be to say the model may predict risk but

19 my level of organisms in the orchard is so low

20 that I just don't need to treat and that would

21 be a huge breakthrough.

22 MR. FELDMAN: Thank you so much. 
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1 We will call you back up if that's okay at the

2 end of the session if we have time for more

3 questions. Thank you very much. 

4 DR. GRANATSTEIN: Thank you for

5 having me.

6 MR. FELDMAN: And just to make

7 sure everybody on the board knows why we're

8 doing this specifically on the streptomycin,

9 tetracycline. The board back in Seattle which

10 was spring of 2011 voted to adopt an

11 expiration date of October 2014 which means

12 this issue will be on the agenda in the spring

13 of 2013. So we as a board will be voting. 

14 That's why Dr. Granatstein had that expiration

15 date, request for an expiration date extension

16 up there on the slide.

17 So now we're honored to have

18 Urvashi Rangan from Consumers Union. I'll

19 give a little bit of an introduction of Dr.

20 Rangan who has a Ph.D. in environmental health

21 sciences from Johns Hopkins. 

22 She heads up the Consumer Safety
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1 and Sustainability Group for Consumer Reports,

2 is responsible for managing risk analysis,

3 policy assessments, label evaluations and

4 consumer advice for tests, reports. You all

5 know what Consume Reports does.

6 Urvashi joined the organization in

7 1999 and developed the rating system database

8 and website. You're familiar with

9 ecolabels.org for evaluating environmental and

10 food labels. 

11 In 2005 she managed the launch of

12 GreenerChoices.org which covers green aspects

13 over a wide range of products and services. 

14 She testifies before Congress, has two young

15 children and is generally recognized to be a

16 super woman. So thanks for joining us.

17 DR. RANGAN: Thanks, Jay, that's

18 really nice. Thanks, everybody. It's good to

19 be here, I haven't been here in a little

20 while. So with that introduction, thanks. I

21 haven't met a lot of the new members on the

22 board but it's a pleasure to be here. 
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1 I am a scientist that works for

2 Consumer Reports. We've been educating

3 consumers about what organic is and what it

4 isn't and what it should be and what the value

5 is for consumers for quite a long time. 

6 And so I'm here today to talk a

7 little bit about the consumer perspective with

8 regard to antibiotic use on apples and pears. 

9 And really I think kind of what roots what

10 consumers don't know at this point. 

11 And I think Dave gave an excellent

12 presentation and I've had an opportunity to

13 hear his talk before on the alternatives. 

14 It's a real problem. We'll definitely give

15 you that, it's a real problem. But I think

16 when it comes to consumers and organic they

17 don't know that antibiotics are being used on

18 apples and pears. We have not had that public

19 discussion. 

20 And so while it may appear that

21 there is a growing demand for this organic

22 commodity and even other organic commodities
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1 that don't quite meet the standard the demand

2 is a little bit hollow in that consumers

3 actually don't know. 

4 And I'm going to mea culpa, we're

5 part of the problem. We haven't talked about

6 this issue in the public and when we learned

7 about it in 2005 or `06 we were hoping for

8 sunset within that period of time and then

9 things just got re-listed. And so we as a

10 consumer group are part of this problem, that

11 we haven't had a public dialogue about it. 

12 And now we're standing here in 2012 and we're

13 still having this same discussion.

14 So I'm going to get into the ins

15 and outs of why this is a problem. And I

16 think we all need to sort of take stock of the

17 fact that we're going to have to prepare to

18 have a public dialogue about this so that

19 consumers can truly understand what it is the

20 problem is. And I think we all need to think

21 about solutions in the short and long term.

22 So the first thing I want to get
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1 into is the law itself. And the OFPA

2 specifically states that organic is about the

3 reduction of external and off-farm inputs, and

4 elimination of synthetic pesticides and

5 fertilizers and other materials such as

6 hormones and antibiotics. And that's just the

7 law so that's what underwrites all these

8 things. We go back to that often when we're

9 trying to talk to consumers about what organic

10 means, what it should mean, what the basis is,

11 what the principles are.

12 And just oddly, I was sort of

13 Googling around to prepare for this

14 presentation and I came across our own

15 comments from May 2000 before the rule had

16 been implemented. And we actually noted this

17 very problem. And this was before anything

18 was put on the National List. But we had

19 concerns about the fact that there was an

20 explicit prohibition of antibiotics for

21 livestock production and yet that didn't apply

22 to crop production. And we found that to be
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1 inconsistent and could potentially mislead

2 consumers if antibiotics were to ever be

3 approved for crop production. And so they

4 were.

5 In terms of the science there's a

6 lot of science behind it. I think -- I'm

7 sorry, this is terrible, it's a little bit too

8 small but let me just read this to you. I

9 think we're in a race to the bottom with

10 antibiotic use in the apple and pear industry. 

11 And it's a race to the bottom it seems like

12 not just for organic apples and pears but for

13 the whole industry. 

14 And we've essentially created a

15 super blight. We have blight that is now

16 resistant to a lot of these antibiotics. And

17 it's not unlike a super bug on the farm. It's

18 a growing problem, it's an industry-wide

19 problem. It seems like a problem. I think

20 we've been adequately convinced of that.

21 Plans to approve other antibiotics

22 like gentamicin have been blocked due to
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1 public health concerns and the CDC has voiced

2 that explicitly. The World Health

3 Organization has actually declared the use of

4 streptomycins and tetracyclines to be both

5 critically important, that's Tier 1

6 classification of those, and that high7 frequency of any use of these antimicrobials

8 regardless of indication can result in

9 pressure for resistance. 

10 Plasmids from gram negative

11 bacteria of which the blight is can transfer

12 resistance. It may be slightly lower in this

13 particular application but the notion that it

14 can transfer resistance is definitely there

15 and rooted in science. And we know that

16 recently introduced varieties over the last

17 decade are more prone to blight. 

18 And so while antibiotic resistance

19 is a major issue there is the minor issue of

20 antibiotic residues. We tend not to focus on

21 that when we talk about animal welfare and

22 antibiotic use in that because it's a more
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1 minor concern. 

2 However, there is a study and I've

3 cited it here that shows streptomycin residues

4 found on some apple and pear samples that were

5 treated 4 to 6 months after application in the

6 fruit itself. And I think that's just yet

7 another problem. It isn't the only problem

8 but it is yet another one. So, we've got

9 scientific issues that consumers can get their

10 heads around. 

11 We have a whole campaign, by the

12 way, called "Meat on Drugs" which is all about

13 antibiotics and the meat production industry

14 trying to get the conventional industry to

15 move toward prudent use of antibiotics and

16 trying to move the market toward getting rid

17 of antibiotics in that production system. It

18 isn't unlike this particular system, it's just

19 that consumers really don't know a whole lot

20 about it.

21 I think where consumer demand is

22 when it comes to organics is in the integrity
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1 of it. And I hear a lot of discussion over

2 the years about consumer demand, the drive to

3 grow the market, the drive to meet that

4 demand. But when you compromise integrity to

5 meet demand you do something very damaging in

6 the short term and the long term. You do

7 something damaging not only to the particular

8 commodity where standards are being lowered

9 but you do something to the overall integrity

10 of the organic industry and people will

11 extrapolate. 

12 And if the Stanford study isn't

13 proof of that I don't know what is. People

14 extrapolate lack of benefit, lack of value

15 when they feel cheated, when they feel like

16 the threads are sort of coming loose even

17 though maybe from the whole system that's not

18 the problem. 

19 So the importance of organic

20 remaining a credible, commercially viable

21 model of how sustainable ag practices can

22 succeed in a market is really important. It's
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1 important to us too, that's why we spend time

2 educating people about this.

3 The primary goal for the NOP as a

4 program, for you as a board is to hold the

5 standards strong and strengthen it over time,

6 not to grow a market for sub-par organic

7 products. And that applies to whether we're

8 approving synthetics ad nauseam, or whether

9 we're talking about aquiculture that doesn't

10 meet the standard. We run into this issue

11 over and over and over again. 

12 And so I always wonder is organic

13 going to be a floor or a ceiling. And I have

14 this existential discussion with lots of

15 people. Maybe it's not going to be a ceiling

16 because there's other labels out there that

17 are exceeding organic in lots of different

18 ways and they're going to compete with

19 organic. And in the end the better ones will

20 win out.

21 And there are other labels like

22 the sustainable label which is going to come
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1 and try and compete directly with this

2 program. So the more the standards start to

3 get chipped away in organic the more equivocal

4 you sort of make it with programs that really

5 aren't going to go all the way to the gold

6 standard. And that is going to be the

7 beginning of really I think the undermining of

8 what organic means to consumers in terms of it

9 being a gold standard.

10 If it's going to remain a floor at

11 least we need to keep it nailed in. We can't

12 start taking out the boards and having it not

13 have a floor. So the floor that is there

14 needs to exist, it needs to be solid, it needs

15 to be maintained. We'd argue you need to

16 increase the standards over time, but at the

17 very least the floor has to be maintained.

18 The allowance of antibiotics is

19 just not in line with what organic means for

20 most foods and consumers don't expect it. And

21 the industry is marketing itself as no

22 antibiotics. You just have to take a trip
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1 through the store aisle and start reading

2 boxes of Nature's Path cereal or whatever else

3 you want to pick up. This industry is

4 marketing itself as providing value-added by

5 not using those materials. 

6 So this isn't just a consumer

7 issue. It's not just about consumers don't

8 get it. This is an industry that has staked

9 itself on these principles and yet they're

10 sort of being chipped away. So the honesty

11 and the added value that organic conveys is

12 constantly under scrutiny. 

13 I get calls all the time from

14 reporters and I'm going to get into some of

15 those questions as to how it compares in the

16 marketplace, how is it doing compared to other

17 labels out there. And as the market grows for

18 this industry the scrutiny will also grow. 

19 And when the value is compromised so is

20 consumer trust. And that's a very simple

21 equation. It doesn't just apply to organics,

22 it applies across the board.
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1 And as I mentioned before there

2 are other labels on the market that are

3 offering better choices in certain cases and

4 in some cases worse, right? Natural is still

5 constantly confused with organic. And yet

6 chipping away at these standards starts to

7 move it toward natural. And so people who buy

8 natural and even pay more for natural are not

9 going to be enticed to go to organic because

10 it won't be that much of a difference in their

11 minds. 

12 And so this is the long-term

13 ramifications of chipping away at standards

14 slowly where it's confusing as to what the

15 principles are. It isn't always the case that

16 something is prohibited. And so it starts to

17 get dumbed down. And natural is a dumb label. 

18 And we don't want to see organic dumbed down

19 to natural.

20 So, fair competition. You have a

21 whole sector of this industry that's not

22 allowed to use antibiotics and that's really
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1 hard for them. The livestock and dairy

2 industry conventionally uses tons of

3 antibiotics. And as I mentioned it's the

4 subject of a massive marketplace campaign we

5 have going on.

6 You have a sector that is going

7 over and beyond to not use antibiotics and

8 makes lots of claims about that too in their

9 marketing materials. And yet why should a

10 sector now in organics be able to use it? It

11 is unfair in terms of the competition even

12 within organics itself. 

13 I guess the one advantage of the

14 controversy in all of this is that we finally

15 have some research and development going on

16 and that's a really good thing because it

17 seems like this industry is in a bit of dire

18 straits when it comes to useful tools to fight

19 the diseases that they have going on. And

20 that's a really good thing.

21 We know Europe organic doesn't --

22 you can't send those fruits to Europe if
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1 they've been treated with antibiotics. So

2 there's some feasibility here. And as Dave

3 was sort of explaining it's slow but we're

4 starting to get there. And it certainly seems

5 like we can do it at times, we can do it with

6 certain varieties and it is feasible for some

7 of this market to move ahead that is truly

8 organic.

9 You also have regions where

10 resistance to these drugs is completely

11 persistent so they're at a disadvantage,

12 aren't they, from being able to use this tool

13 to fight those diseases. So even within the

14 organic apple and pear industry sector there

15 is sort of unfair competition going on with

16 the allowed use of these antibiotics. So that

17 kind of covers the fair competition question. 

18 One thing I want to get into here

19 is what we have to field from the media all

20 the time. And here are just some -- here we

21 go again, sorry about this. I'm going to read

22 them.
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1 So, here are some questions we get

2 in the media. What was the purpose of

3 creating an organic law and federal program? 

4 Why did we do it? Why did we go to all the

5 trouble? Our answer is generally to impart

6 consistency into what organic meant for

7 consumers and farmers and to minimize

8 confusion in the marketplace. That's why we

9 did it. So why are we creating all these

10 inconsistencies as we move forward? But that

11 is what this is, this is an example of that.

12 Another question we get, organic

13 food, is it worth it? What does it mean? 

14 Often the title -- and it's often the title of

15 a lot of articles. And then we end up with

16 this crazy answer of most organic foods meet

17 certain standards and principles but there are

18 exceptions. And organic foods with the most

19 value are produced without synthetic materials

20 or antibiotics but others aren't. Or the

21 standards that apply to most food don't apply

22 to other foods. Or some animals go outside
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1 but some may not. Or there's inconsistency in

2 the meaning which is why we went to the

3 trouble of creating the federal program in the

4 first place. So we end up with completely

5 convoluted answers for the media to talk about

6 what organic was meant to be, what it is now. 

7 You can start to understand why

8 consumers are going what? What do you mean? 

9 I thought that wasn't allowed? Now you're

10 saying it is allowed. I don't get it. And

11 when consumers start to feel cheated, that's

12 when the bottom starts to fall out.

13 I just, I want to go quickly here

14 into consumer understanding. And I just want

15 to talk very quickly here. This is Organic

16 Valley. Organic means no antibiotics, that's

17 their marketing materials on here. So anyway,

18 suffice to say there's a lot of ads going on.

19 In terms of moving forward we've

20 got to prepare for the public conversation

21 about this. We have to have a public

22 conversation about this. People don't know
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1 about it. We don't think apples and pears

2 that are treated with antibiotics should be

3 called organic. 

4 And I'm sorry, it's -- that is not

5 something that is easy for us to come here and

6 say. I think we feel like there is a lot of

7 hard work going on in this industry and we

8 have a lot of sympathy for this industry. It

9 seems to be in trouble in terms of the tools

10 it has. It still shouldn't be called organic.

11 Alternative labels, maybe

12 transitional and conversion should be

13 considered. And truly organic apples and

14 pears that are produced without antibiotics

15 should be able to honestly differentiate

16 themselves in the marketplace. They can't do

17 that right now. 

18 And I think the industry has got

19 to stop pledging the use of antibiotics. We

20 can't have any more exemptions to this. We

21 don't think it should be re-listed. And we

22 think there needs to be a public education
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1 campaign. And we have a role to play in that

2 too in terms of which varieties don't -- are

3 more resistant to fire blight than others. 

4 And we think this increased transparency in

5 the marketplace are going to help consumers

6 and farmers get on the right track. 

7 Consumers want to know you're

8 going to hold the integrity of this label

9 high. So if you say we're just not going to

10 have as many apples and pears on the market

11 for the next 5 years because we've got to get

12 our act together so that we can meet the high

13 standard that you've come to expect then

14 that's what we have to do. Because your job

15 in holding that standard high is more

16 important than creating a short-term market

17 for sub-par organic goods now. 

18 And so we really urge you to move

19 in that direction. Let's have an honest

20 dialogue with the public and let's find

21 solutions so that we can eventually have an

22 organic apple and pear industry and do it
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1 right where it truly means what consumers

2 expect from other organic food. Thank you.

3 MR. FELDMAN: Thank you, Urvashi. 

4 A minute for questions. 

5 MS. SONNABEND: Thank you,

6 Urvashi, that was a good presentation. I

7 think all of us on any stakeholder side of

8 this issue agree that part of the reason we

9 got stuck here is because there was no real

10 way to spur more research into the very badly

11 needed alternatives to the antibiotic

12 substances. 

13 And so I'm wondering if you have

14 any suggestions for us on how we can encourage

15 and inspire more research and ways that

16 consumers could help out the growers in trying

17 to put on pressure for more research to be

18 done on this.

19 DR. RANGAN: Well Zea, I think

20 that's a great question. And I think again in

21 trying to have a transparent public dialogue

22 about it we have to talk about the fact that
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1 we've been stuck in this corner of this box,

2 and that research and development hasn't

3 really taken place. And we need to do that. 

4 And I think hopefully with

5 consumer demand for that and pressure to push

6 back so that we do even increase the amount of

7 R&D that's going on, I think we need to do

8 that. Should they be called organic in the

9 meantime? I think that's where we disagree. 

10 And I think something to

11 demonstrate that there is movement in this

12 direction, that there is clearly some value to

13 be had in the production practices that are

14 going on compared to conventional, we need

15 something different to call them. And is it

16 in conversion? Is it transition? I don't

17 know, but it's not organic. 

18 MR. FELDMAN: Thank you, Urvashi. 

19 I wish we had more time for this. We will see

20 if we have more time for questions at the end

21 of this session.

22 DR. RANGAN: Okay, thanks.
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1 MR. FELDMAN: Thanks again. Kiki. 

2 Is Kiki in the house? Yes. 

3 I'd like to introduce our next

4 speaker. And the presentation from Kiki will

5 be on organic seeds. She is a director of

6 advocacy, Kiki Hubbard, the director of

7 advocacy and communications for the Organic

8 Seed Alliance, a national organization that

9 advances the ethical development and

10 stewardship of seed.

11 She's worked for a decade as an

12 organizer, researcher and writer on projects

13 involving agricultural biotechnology and

14 antitrust issues in the seed industry. 

15 She was awarded a Doris Duke

16 Conservation Fellowship to examine the

17 implications of genetically engineering

18 alfalfa and has taught at the University of

19 Montana.

20 She's a resident of Montana and

21 serves on the board of directors for the

22 Montana Department of Agriculture's Organic
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1 Commodity Advisory Council and Alternative

2 Energy Resources Organization. Thanks so much

3 for making the trip and coming here. Thanks.

4 MS. HUBBARD: Thanks, Jay, and

5 thank you to the board members and NOP staff

6 for inviting me. This is actually my first

7 NOSB meeting and I feel really honored to be

8 participating as a presenter.

9 Organic Seed Alliance as Jay said

10 works to advance the ethical development and

11 stewardship of seed. We believe that seed is

12 a part of our common cultural heritage and

13 demands careful management. And so to that

14 end we work closely with organic farmers and

15 other seed professionals to support the

16 ongoing growth of organic seed systems through

17 research, education and advocacy programs.

18 Our vision is for us to have here

19 in the U.S. and organic food system built on

20 the foundation of seed that is well adapted to

21 organic conditions and provides diverse

22 options for farmers when it comes to their
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1 regional and market needs.

2 Today I'm going to talk a bit

3 about an ongoing project of OSA called "The

4 State of Organic Seed." Each of you board

5 members receive a copy of the State of Organic

6 Seed Report I believe last year. I'm going to

7 talk a bit about the findings today and talk

8 about some of our work since publishing this

9 report through diverse working groups to move

10 forward some of the recommendations that were

11 identified in this project. 

12 So "The State of Organic Seed" is

13 an ongoing project as I mentioned to monitor

14 opportunities and challenges in building the

15 organic seed sector. There's a real need for

16 this because as you know despite impressive

17 growth in the organic food industry the

18 organic seed sector has simply not kept up

19 with this demand. And we're facing limited

20 availability of appropriate organic seed for

21 a number of reasons, one of which is the lack

22 of clarity when it comes to how to enforce the
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1 organic seed requirement as I'll talk about a

2 bit later. 

3 But there are other reasons as

4 well, including consolidation in the seed

5 industry where companies who were providing

6 organic seed or looking to invest in organic

7 seed were either merging or bought out by

8 companies with no interest in organic. We've

9 seen a decrease in public funding of plant

10 breeding as well as fewer investments both

11 publicly and privately in organic plant

12 breeding in general among other reasons.

13 The lack of organic seed we

14 believe is a barrier to the organic food

15 industry. And I think we can all agree that

16 organic food integrity starts with organic

17 seed integrity, whether we're talking about

18 the problem of GMOs or simply the commercial

19 availability of organic seed. 

20 So we set out to look at the

21 challenges in organic seed systems, published

22 the report that you all have a copy of and
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1 then as I mentioned before facilitate some

2 working groups to move some of the solutions

3 forward. 

4 And the assessment tools we used

5 to conduct this analysis included a producer

6 survey. We sent out a survey to certified

7 organic crop growers across the U.S. which

8 I'll talk about in a minute. We looked at

9 organic seed funding both in the public and

10 private sector to see where we're at in terms

11 of investments in improving crops for organic

12 systems. 

13 We hosted an organic seed

14 symposium in 2010 with more than 100 organic

15 stakeholders to look at the preliminary data

16 we had collected and talk about next steps and

17 recommendations which we then published last

18 year in our State of Organic Seed Report.

19 So, the farmer survey that we

20 conducted, the goal of that was to assess

21 organic farmers' current attitudes and

22 perceptions toward organic seed and to look at
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1 what some of the challenges were or barriers

2 to accessing or using organic seed.

3 At the time and still today

4 there's a lot of anecdotal evidence as to why

5 more organic seed isn't used in certified

6 operations, but we wanted to go to growers

7 directly and ask very specific questions

8 ranging from usage to challenges to needs and

9 potential in organic plant breeding.

10 I want to mention that a total of

11 25 agencies, organizations and businesses

12 helped us distribute this survey. And we'll

13 comfortable saying that it represents about 10

14 percent of certified organic crop growers in

15 the U.S. And so while we believe it's a very

16 useful discussion tool we do acknowledge that

17 it's not an exact measurement. We do plan to

18 continue this project and update the survey

19 and report every few years or so.

20 So I can only provide a snapshot

21 of the data today. I encourage board members

22 as well as those in the audience to go to
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1 SeedAlliance.org and access our State of

2 Organic Seed Report. You will find pages and

3 pages of useful data representing the survey

4 we conducted with farmers.

5 One of our goals was to capture

6 demographics that reflect the diversity of

7 certified organic producers in the U.S. when

8 it came to crop type, geography and scale or

9 size of acreage. You'll see here that 43

10 percent of the producers who responded to our

11 survey were -- grew some vegetables, 60

12 percent grew some fuel crops and 48 percent

13 grew some forage crops. 

14 Overall about 20 percent of

15 farmers who responded to the survey indicate

16 that they are using 100 percent organic seeds. 

17 So this should not be read as only 20 percent

18 of farmers are using some organic seed. 

19 Twenty percent indicate that they are sourcing

20 all organic seed for their operations. Seven

21 percent indicated they use no organic seed. 

22 And then you'll see there some numbers
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1 regarding total acreage of vegetables, fuel

2 crops and forage that are planted to certified

3 organic seed again based on our data set that

4 I described earlier.

5 Vegetable crops clearly lag behind

6 according to our data when it comes to

7 availability and usage with only 69 out of 437

8 vegetable producers using all organic seed.

9 Some encouraging data that I want

10 to share today is that over the last 3 years

11 we asked organic farmers if they have

12 increased the percentage of organic seed that

13 they use over the last 3 years and many of

14 them as you can see here, the majority of them

15 indicated that yes, they have increased their

16 use and sourcing of organic seed. About 20

17 percent have been using 100 percent certified

18 organic seed for at least 3 years.

19 Another encouraging point is that

20 we asked if their certifiers have been

21 encouraging them to take extra measures to

22 source organic seed, "extra measures" meaning
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1 going beyond three seed catalogs or sources of

2 organic seed or conducting variety trials on

3 their farm to see which organic varieties

4 might be optimal in their systems and replace

5 untreated conventional varieties that they're

6 relying on.

7 And here we see that more than 60

8 percent responded yes, that their certifiers

9 were indeed encouraging them to take extra

10 measures to source organic seed. Not

11 surprisingly, lo and behold, when farmers were

12 encouraged to take extra measures to source

13 organic seed they responded by planting more

14 organic seed which I think is very useful in

15 terms of recommendations to the NOP to support

16 certifiers' role in supporting again the

17 increased use of organic seed.

18 When it came to challenges in

19 sourcing or using organic seed we see that

20 more than half of the farmers responding to

21 our survey indicated that the availability of

22 certain varieties was a significant factor. 
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1 Seventy-nine percent indicated that it was a

2 moderate or significant factor.

3 The lack of availability of

4 certain varieties was more of an issue with

5 vegetable growers according to our data than

6 fuel crop and forage growers. And then more

7 than 40 percent indicated that price was a

8 factor. And we know that price is not allowed

9 to be a factor when choosing not to use

10 organic seed, and yet we see that again more

11 than 40 percent indicated that this was a

12 challenge for them.

13 We were surprised that distrust of

14 organic seed quality was not more of an issue

15 among our responses. Here we see that with

16 the question when we asked if there was some

17 distrust of organic seed quality that only 10

18 percent indicated it was a moderate factor and

19 even fewer indicated that it was a moderate or

20 significant factor, more than a moderate

21 factor. 

22 So, furthermore we asked farmers
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1 if they had more, less, or about the same

2 degree of quality issues in organic seed

3 versus conventional and treated seed. And we

4 found that 73 percent of respondents had about

5 the same experience with both types of seed

6 and 23 percent had more problems with organic

7 seed.

8 We asked some questions about

9 genetic integrity issues which is especially

10 appropriate for today's conversation. More

11 than 70 percent of farmers responding to the

12 survey agreed that seed companies should be

13 testing for the unwanted presence of

14 genetically engineered material. This should

15 come as no surprise I'm sure. 

16 And the majority of farmers

17 responding also indicated that they don't

18 believe the current regulatory framework in

19 place -- governing genetically engineered

20 crops I want to specify -- do not believe that

21 this current framework is strong enough to

22 protect organic integrity. 
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1 For those of you not familiar with

2 the coordinated framework for biotechnology

3 there has never been a new law created to

4 address the unique concerns of genetically

5 engineered organisms and instead our

6 government relies on a patchwork of existing

7 laws, some of which predate the technology, to

8 govern the oversight and regulation of

9 genetically engineered crops. And I think

10 this response again reiterates that there's a

11 lot of concern in our farm field and in our

12 farming communities especially among organic

13 farmers that we need better oversight and

14 regulations to protect the integrity of

15 organic.

16 More than 40 percent indicated

17 that their farms are at risk from seed

18 contamination or GE contamination of their

19 seed while 30 percent were neutral.

20 We asked questions about farmers'

21 perspectives on the value of organic seed in

22 breeding. We were pleased to see that the
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1 majority of those responding agreed that

2 organic seed is important to maintaining the

3 integrity of organic food production and that

4 more than 80 percent agreed that varieties

5 bred for organic systems are important to the

6 overall success of organic agriculture.

7 And then more than half of the

8 farmers responding said they had some interest

9 in engaging in organic seed production

10 commercially, especially if there was economic

11 value and conducting on-farm crop improvement

12 projects. 

13 Organic Seed Alliance sees a ton

14 of potential for participatory plant breeding

15 projects and on-farm variety trial networks in

16 order to strengthen and increase availability

17 of organic seed. It's a major program goal of

18 ours and our research and education if you

19 want to learn more about that. 

20 But at the end of the day we just

21 believe that farmers are central to expanding

22 crop diversity and expanding innovation in
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1 seed in our farm fields.

2 We also asked farmers just as a

3 quick side note which crop types they thought

4 were in most need of attention when it came to

5 improvements for organic systems. I have not

6 shared this data today but that is in the

7 report as well.

8 We looked at, as I mentioned

9 earlier, some of the investments in research

10 to support the growth of organic seed systems. 

11 Since 1996 there have been 57 projects working

12 directly on organic seed projects. More than

13 $9 million have been invested in these

14 projects. The largest contributors have been

15 USDA's OREI grant program as well as SARE

16 grants. And the crops that have received the

17 most attention include wheat and vegetables. 

18 And regionally the Midwest has received the

19 majority -- not the majority, but more funds

20 than other regions.

21 I think it's pretty safe to say

22 that this is a modest investment in organic
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1 plant breeding and seed system development

2 given that the organic food sector is now

3 worth more than $30 billion.

4 So, some conclusions. Just to

5 wrap up some of what I've already said,

6 organic seed use is improving. We have seen

7 improvements with farmers attempting to source

8 more organic seed and pressure from certifiers

9 to do so. But we do believe that there needs

10 to be increased attention and resources given

11 to organic seed system development. And there

12 does seem to be a clear link as I indicated

13 earlier between certifiers encouraging farmers

14 to take extra measures to source organic seed

15 and farmers responding and sourcing more

16 organic seed.

17 Farmers clearly want organic seed

18 protected from genetically engineered traits. 

19 There's a need to improve information-sharing

20 which I'll talk about in a second in the areas

21 of organic seed availability. 

22 And as some of the data indicated
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1 farmers see organic plant breeding and organic

2 plant breeding important to organic farmers

3 and their success to the broader organic

4 industry. And there's a need as I mentioned

5 to create opportunities for organic farmers to

6 work with professionals in on-farm trials and

7 on-farm crop improvement projects. 

8 So, one of the most important

9 outcomes from this project has been that

10 there's a general agreement among stakeholders

11 that we need collaborative and comprehensive

12 solutions. So last year Organic Seed Alliance

13 initiated and facilitated four working groups

14 in the areas of organic plant breeding, seed

15 industry concentration, information-sharing

16 and seed integrity. 

17 I'm not going to talk about all

18 these working groups, I doubt I have time, but

19 the Organic Plant Breeding Working Group is

20 comprised of about a dozen public plant

21 breeders who are actually in the process of

22 creating a research agenda for organic plant
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1 breeding which is pretty exciting. They have

2 also been involved in communicating to the

3 USDA the need to bolster support for classical

4 plant breeding that results in public

5 cultivars that meet the regional needs of

6 farmers including organic farmers.

7 I'm going to try to touch on the

8 Information Working Group activities and the

9 Seed Integrity Working Group activities. One

10 of the working groups that we've been working

11 closely with has had the objective of

12 improving organic producers' ability to meet

13 the NOP requirement to use organic seed. 

14 I'm pleased to say that this

15 working group has successfully helped launch

16 a new organic seed database as of this month. 

17 It is called Organic Seed Finder. We have met

18 monthly, at times more frequently, since March

19 of 2011 to develop and implement a new organic

20 seed database working with OMRI to learn about

21 their experience and develop a model that is

22 sustainable and again meets the needs of all
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1 organic industry members.

2 This is a snapshot of Organic Seed

3 Finder. It is hosted by AOSCA, the official -

4 - the Association of Official Seed Certifying

5 Agencies. AOSCA has wonderful in-house seed

6 expertise. Organic Seed Alliance and our

7 partners has provided the necessary support on

8 behalf of the organic community to ensure that

9 this database is successful since AOSCA before

10 did not have any real ties with the organic

11 community. 

12 The database is user-friendly. 

13 AOSCA is encouraging feedback from all

14 stakeholders. It is free and open to farmers

15 and certifiers and others looking to source

16 organic seed. And it is funded through seed

17 vendor fees as well as sponsorships. 

18 We've had some great response from

19 the organic food industry in wanting to

20 sponsor this database through small and large

21 contributions simply to showcase their support

22 of the organic seed industry and recognize
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1 that food starts with seed and we need good

2 organic seed in order to have good organic

3 food.

4 I included this red arrow up there

5 because one neat feature of this database is

6 that there's an opportunity for farmers to

7 document and share which varieties they're

8 looking for in an organic farm but can't find. 

9 So this creates a feedback loop to the organic

10 seed industry, to organic plant breeders

11 through our working group and others so that

12 we can identify what the needs are among

13 farmers around the country.

14 This is the website for finding

15 Organic Seed Finder. If you have questions

16 you can contact AOSCA at this email address.

17 And then quickly, I've already

18 shared a bit this morning in my seed purity

19 comments some work from the Seed Integrity

20 Working Group. And this is a group that

21 looked at some opportunities in protecting the

22 genetic integrity of seed use in organic
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1 systems.

2 We first sent a letter to the NOSB

3 and NOP asking them to make the GMO issue more

4 of a priority and thankfully as we've learned

5 today they have and we're very grateful for

6 that. We have also had discussions about a

7 seed purity standard some of which is

8 reflected in the questions I included in my

9 written comments.

10 And then this working group

11 informed the survey that I mentioned earlier

12 today where we discussed some of the risk

13 points for the organic seed industry at the

14 time to inform comments that I provided to the

15 AC21 committee. Again, that's the USDA's

16 Advisory Committee on Biotechnology. And we

17 are tentatively planning a meeting to further

18 this discussion in February.

19 I think I'm just going to wrap it

20 up here. These were a few more findings from

21 the survey. You can find the survey findings

22 at our website, again, SeedAlliance.org. 
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1 But we did ask these seed

2 companies that we talked to many more

3 questions beyond can you meet a genetic purity

4 standard. We wanted to get a sense of were

5 they experiencing financial harm, were they

6 facing barriers to eradicating genetically

7 engineered material. 

8 The last thing I want to mention

9 is that the issue of concentration in the seed

10 industry is very tightly linked to the issue

11 of protecting seed integrity in that our plant

12 genetic resources are often in many cases such

13 as hybrid breeding lines, hybrid corn breeding

14 lines concentrated in the hands of a few. 

15 And seed companies who are looking

16 to provide for the organic industry often have

17 a hard time licensing untreated germ plasm to

18 use for organic seed production. At times

19 these licensing agreements even come with

20 restrictions on testing for genetically

21 engineered material. Again, these are players

22 who are looking to provide seed to the organic
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1 community that meets our standards including

2 not having excluded methods in the end

3 product. 

4 And these were our recommendations

5 that I've already provided in written form

6 regarding the draft guidance document on the

7 commercial availability of organic seed. I've

8 already mentioned some of them. I guess I

9 should stop because I don't have more time

10 unless you want me to take 30 seconds.

11 MR. FELDMAN: Thank you so much.

12 MS. HUBBARD: You're welcome.

13 MR. FELDMAN: Really comprehensive

14 and helpful. Thank you. Are there any

15 questions from board members? John.

16 MR. FOSTER: Thanks, Kiki. As you

17 know we all appreciate that work you're

18 continuing to do there. 

19 My question is kind of focused on

20 the difference between varietal, limitations

21 on variety versus performance characteristics. 

22 And in that survey was the term "variety" used
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1 to mean also performance characteristics? Or

2 was the interpretation on the people who were

3 filling it out more that when you said variety

4 you meant marathon broccoli, for example?

5 And as you know, there are many

6 different varieties that may have the same

7 performance characteristics. So my question

8 is more about do you think the survey was

9 filled out with that broader kind of idea

10 about other varieties that might also fit the

11 bill, or did most people read it as in I

12 wanted marathon broccoli and I couldn't find

13 marathon broccoli so that's where I stopped.

14 MS. HUBBARD: John, I prefer it

15 was -- I believe it was the former. I

16 actually was not with Organic Seed Alliance

17 when the survey was first put together. The

18 State of Organic Seed Report does detail the

19 methodology including how the questions were

20 put together. In fact, copies of the

21 questions are in the report. So I'm sorry I

22 can't give you an answer for certain but I
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1 believe it's the first thing you mentioned,

2 just the variety and not performance traits.

3 MR. FELDMAN: One last quick

4 question.

5 MR. MARAVELL: You were talking

6 about going forward on farm trials,

7 cooperation with plant breeders for classical

8 plant breeding. And then you mentioned

9 something called public varieties. I was

10 wondering if you could expand a little bit and

11 whether or not there was anything in your

12 survey about how farmers, what sort of

13 varieties they are looking for in terms of

14 public and sometimes called public domain type

15 varieties.

16 Could you say -- would that be

17 something that organic farmers should continue

18 to desire? Or is that a pipe dream that we

19 will have varieties in the future in the

20 public domain?

21 MS. HUBBARD: That's a great

22 question, Nick, and it's something we talk a
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1 lot about. Right now when it comes to demand

2 for public varieties I really can only rely on

3 anecdotal evidence through my conversations

4 with farmers who lament the fact that they no

5 longer have as much access to seed held in the

6 public domain. This is especially true in

7 soybeans as I understand it with past research

8 that I've done.

9 I hope it's not a pipe dream. I

10 think the public sector has an important role

11 to play. It's an important form of

12 competition in the seed industry to have

13 public seed available. It's the 150th

14 anniversary of USDA and when they started one15 third of their budget went to germ plasm

16 collection and distribution. 

17 I mean, it's a principle of the

18 Department of Ag and our land grant university

19 system. So we really hope to see funds going

20 toward projects that -- breeding projects that

21 result in cultivars that are held in the

22 public domain. 
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1 It's a complicated issue that

2 includes different laws like the 1980 Bayh3 Dole Act that allows public research to be

4 patented. It's complicated.

5 MR. FELDMAN: Thank you. We

6 depend on Nick to raise complicated issues for

7 us. So with that thank you so much.

8 MS. HUBBARD: Thank you.

9 MR. FELDMAN: We really appreciate

10 it. We'd like to ask all the presenters

11 today, why don't we give them a round of

12 applause, everybody.

13 (Applause)

14 MR. FELDMAN: We'd like to ask if

15 all the presenters could share with us their

16 written documents or written, printed

17 documents of the presentations if that's

18 possible. Could we find that out somehow,

19 Michele, or do you know? Okay. Thank you.

20 Well, I hand the gavel back to the

21 chairman of the board. Thank you very much.

22 CHAIRPERSON FLAMM: Thank you very
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1 much. Those were excellent presentations. 

2 We're about 5 minutes past our break time so

3 let's get back together at 1:20.

4 (Whereupon, the foregoing matter

5 went off the record at 12:19 p.m. and went

6 back on the record at 1:39 p.m.)

7 CHAIRPERSON FLAMM: The meeting is

8 back in order and we'll continue with the

9 Crops Committee and public comment. I'll turn

10 it back over to Jay Feldman.

11 MR. FELDMAN: Thank you. Welcome

12 back from lunch. I know everybody is

13 energized by their nutritious meals.

14 So I wanted to, Barry, take just a

15 minute to correct the record on some of our

16 reporting on the public comments. I just want

17 to update the record for the record on the

18 Crops Subcommittee there were some comments

19 that may not have been fully captured in our

20 biodegradable bioplastic mulch film

21 discussion. 

22 What we try to do in that as you
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1 know, what we try to do when we present this

2 information is give you, give the community,

3 give the board a summary of who said what and

4 how many people weighed in on what side of the

5 issue, et cetera. 

6 And I guess what happened is

7 Cornucopia got left off so we need to make

8 sure the record reflects that they suggested

9 that we as a board did not have sufficient

10 information and need separate petitions on the

11 individual synthetic plastic film ingredients. 

12 So they're suggesting that they be

13 individually reviewed. And I guess we'll hear

14 more about this from Pam when she speaks

15 during this session.

16 Similarly we neglected to include

17 during the GMO discussion a comment of

18 Cornucopia on their really strong belief that

19 when we're looking at this question of GMO

20 that we include an equal look at both organic

21 growers' use -- or an especially important

22 focus on organic growers' use of conventional
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1 seed and the GMO implications associated with

2 that.

3 Again, we try to be as thorough as

4 we can with this process and sometimes we miss

5 the mark a little bit. And those that -- many

6 of you are out there are scrutinizing us

7 closer than others, that's all I can say. So

8 we want to make sure that the record reflects

9 all the hard work that you all put into this

10 process and all the resources that you expend

11 to get to this meeting and prepare for it.

12 So with that, Barry, I will now

13 turn to the public comment period. 

14 MR. ARNOLD: My name is Paul

15 Arnold. I'm with Pleasant Valley Farm out of

16 Argyle, New York. It's about an hour

17 northeast of Albany. We're about 4 hours away

18 from here. I took the trip down to make some

19 comments.

20 We're a 7-acre diverse fruit and

21 vegetable farm that sells to farmers markets

22 52 weeks a year. We've made our living at
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1 farming for 25 years. It's our sole source of

2 income. We've been using BioTelo for 4 years

3 and we use about four rolls per year which

4 equals about 3 miles of that. We previously

5 did not use any black plastic. 

6 Before that we just did not want

7 to get into the labor of removing it and the

8 disposal of it. I had worked on farms before

9 that and been acquainted with it.

10 Some of our want to use this

11 product is the fact that it does break down

12 quickly. And this helps a lot with the fact

13 that once crops are done we are more inclined

14 to get it turned under right away and put

15 cover crops down immediately which helps us

16 instead of in the summer it's harder to think

17 about taking labor to pick up plastic and then

18 get a cover crop down. So it's helped us a

19 lot in that way.

20 For us it's an excellent product

21 that's doing exactly what they say it's going

22 to do. Whether we use it for products like
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1 onions in the spring and peas, and then get

2 turned under in July when we're done, the

3 product is gone. Or we use it for products

4 like Brussels sprouts that are going to be

5 there the whole season and will get turned

6 under in the fall, late fall, when they get

7 harvested. That product is always there, it's

8 always good for us.

9 We also use it for strawberries,

10 planting them in the fall and then harvesting

11 in the spring. And then we turn under the

12 strawberry crop. The plastic is then gone. 

13 So it's worked well for us.

14 It breaks down easily. There is

15 no residual left that we have seen at any

16 time. We do have some pictures. I think you

17 see the one up here now, it's onions. And

18 then there will be another picture that will

19 come up that is actually not that one but it's

20 another one. That's it right there. That's

21 after turning the onions down in August. So

22 that first picture of onions was in April, the
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1 second -- or May, and then that second picture

2 then was in August. So you see it breaks down

3 completely.

4 It rototills easily with no

5 wrapping. It disappears completely whenever

6 it's put in. I also want to say that we also

7 use it in our high tunnels which is you might

8 say on a dry farm situation in the sense of

9 because we're using drip irrigation that it --

10 there is no real water in there to break this

11 plastic down. 

12 What we do with it, because it's

13 in there for 6 months because we do summer

14 crops with tomatoes and cucumbers, then we

15 also do winter crops with Swiss chard and

16 kale, that we remove it at the end of the

17 season and it gets composted out in our fields

18 along with all the other sheet composting that

19 we do on our farm. Again, there's just

20 nothing left. It takes a very short time for

21 it to break down and it's just not there.

22 So all our workings with it so far
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1 is positive. It lays down easily. It breaks

2 down easily. It's actually allowed us to do

3 a lot more adding of organic matter because

4 between the plastic we use straw and that

5 allows us to add organic matter.

6 We rotate it around our fields and

7 that helps us too. So it's not in one field

8 every year, it's moved around, and that's how

9 we add organic matter to our farm because

10 we've been doing this for 25 years. That's

11 our system so far.

12 MR. FELDMAN: Thank you. 

13 Questions from the board? Mac.

14 MR. STONE: Does it hold up well

15 enough during the season as far as running

16 transplanters over it, having workers stepping

17 on it when they're harvesting or hand-weeding

18 in the holes? Does it hold up well enough for

19 production purposes?

20 MR. ARNOLD: It holds up more than

21 well enough. We really don't have anything

22 negative to say about it. The only thing you
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1 learn to work with it is the fact that after -

2 - if you lay it down you need to be

3 transplanting into it within the first 2 or 3

4 weeks or it starts to get brittle and fall

5 apart.

6 MR. FELDMAN: Zea.

7 MS. SONNABEND: When you first

8 decided to start using it what level of

9 investigation did you do, or did you even

10 think about the concerns of whether it left

11 chemical residues behind from the components

12 that made it?

13 MR. ARNOLD: We looked into the

14 fact that it was already established for use

15 in Europe. And if they had already done the

16 background in it we weren't really chemists

17 enough to know all that background. But as

18 long as it was good for them then we decided

19 we were going to try a small amount. 

20 Our farm is known for doing lots

21 of trials of a lot of different products and

22 keeping up with universities. So this was a
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1 small amount, put it down, one roll, find out

2 what it does and then from there we started

3 using it more when we found it did do what we

4 wanted it to.

5 I guess the concern was still the

6 fact that someone had approved it in Europe

7 and so we were okay to use it here.

8 MR. FELDMAN: Other questions? 

9 This is your chance. Harold.

10 MR. AUSTIN: In your various

11 trials you were talking about your irrigation,

12 drip irrigation in the various trials. Do you

13 have any other form of irrigation besides

14 drip?

15 MR. ARNOLD: Our farm uses

16 overhead irrigation on all of our acreage

17 outside that we grow crops on is overhead

18 irrigation. Where we use drip irrigation is

19 in the high tunnels and things like

20 blueberries in any permanent crop.

21 MR. AUSTIN: Okay. Along with

22 your -- the irrigation then what's your normal
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1 amount of annual rainfall? And then how much

2 -- in the course of your crop year how many

3 acre feet or inches of irrigation water are

4 you applying?

5 MR. ARNOLD: We are -- I'm not

6 going to be able to tell you how many inches

7 we normally get. I'm not versed on that. 

8 What I'm watching for as a farmer is what is,

9 you know, is there enough water going down for

10 the transplants and the crops. 

11 So we're looking at an inch to an

12 inch and a half a week depending on how hot

13 and dry it is during the summer. In May

14 you're not using as much as you are in July

15 when it's hotter and the plants are bigger and

16 need more. So we have a full irrigation

17 system with unlimited water and so we irrigate

18 as much as the crops need to bring them to

19 their potential. So it's often.

20 MR. FELDMAN: Other questions? 

21 Jennifer.

22 MS. TAYLOR: Can you tell me if
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1 you have discovered a financial benefit in

2 using this type of mulch versus your previous

3 one that you had? Or what are your benefits,

4 please?

5 MR. ARNOLD: What are our

6 benefits? Well, we were not doing any black

7 plastic before this so it wasn't a strict one8 for-one going from one to the other.

9 We were doing a lot of mulch, just

10 strictly mulch, putting it down instead of

11 using the black plastic. And what we found

12 was that a lot of crops that liked heat were

13 being held back because this made things too

14 cool for them. So the black plastic made it

15 a little warmer for a lot of the heat crops

16 that you're using as an all-summer crop like

17 cucumbers and zucchini and tomatoes benefitted

18 from earlier pickings on that, a longer

19 season.

20 The only other thing that was a

21 real benefit was of course at the end of the

22 season there was no residuals that we had to
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1 break up and we could get our cover crops down

2 faster which is what was really important to

3 us. 

4 MR. FELDMAN: Other questions? 

5 Thank you, Mr. Arnold. We appreciate it. 

6 Steve Mojo?

7 MR. MOJO: That's correct. Good

8 afternoon. My name is Steve Mojo. I'm the

9 executive director of the Biodegradable

10 Products Institute. I represent the major

11 manufacturers of biodegradable films in the

12 U.S. and Canada.

13 The BPI or Biodegradable Products

14 Institute is a professional trade association

15 with over 150 key individuals and groups from

16 government, industry and academia. And we

17 promote the use and recovery of biodegradable

18 materials. My comments today are on behalf of

19 the petition that we submitted and we greatly

20 appreciate the support of the Crops Committee

21 and agree with the overall decision that this

22 material will benefit the organic community.
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1 Rather than comment on the

2 annotations which I understand may be modified

3 I'd like to spend my time to talk about

4 responses to the public comments that were

5 submitted in the Federal Register.

6 First, I appreciate the overall

7 widespread support from the farming community

8 and at the same time I realize that some

9 participants have legitimate concerns. And

10 I'd like to deal with three fundamental

11 issues, one being why we recommended both 6400

12 and the use of 5988 at the soil test.

13 ASTM D6400 provides an initial

14 rejection point much earlier in the

15 developmental time line so that we understand

16 if a material has the ability to reach the 90

17 percent threshold under accelerated aerobic

18 conditions frequently called composted. 

19 Importantly, 6400 provides an ecotoxicity test

20 at the end of it so that we know that those

21 materials aren't going to harm plant growth.

22 Then if a material meets ASTM 6400
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1 in anywhere from 3 to 6 months then it can go

2 onto the longer term development, the longer

3 term soil test to confirm how long it's going

4 to take to go away under real world conditions

5 or laboratory conditions that simulate the

6 real world. So hopefully that clears up why

7 we have two test methods.

8 Some commenters suggested the

9 materials not only meet these requirements but

10 they also be certified so that the ACAs and

11 MROs can easily determine compliance with the

12 standards. The BPI is willing to establish

13 such a certification program with NSF, an

14 internationally known third party

15 accreditation agency if that's something you

16 would like us to do to make it easier to

17 identify these materials.

18 Third, I want to take the

19 opportunity to clarify the confusion that

20 seems to exist, or the difference that seems

21 to exist between the terms "biodegradable" and

22 "mineralization." While they're often used
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1 interchangeably, fundamentally they are

2 technically different. 

3 Biodegradation is the process

4 whereby living organisms break down foods,

5 assimilate them and convert them into energy

6 to sustain their lives. The process is

7 fundamentally the same for you and I and the

8 soil microbes, they're just eating different

9 foods. The end products of biodegradation are

10 biomass, water and carbon dioxide. 

11 Conversion to the carbon dioxide

12 is the final step of the process. It's

13 mineralization. We know that when things are

14 converted to carbon dioxide they're removed

15 from the soils and they're put into the

16 atmosphere as an inert material. 

17 The test approach that we're

18 proposing and the standards that we're using

19 consider CO2 evolution as the final measure of

20 biodegradation. So we know that these

21 materials have been broken down by the

22 microbes, assimilated, used as a food source
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1 and then respirated out into the atmosphere. 

2 It's the same thing that happens for you and

3 I now that we're eating lunch. We're breaking

4 down our foods, we're breathing, we're moving

5 and sooner or later that's going to be

6 expelled as CO2. So by reaching 90 percent it

7 can be said materials reach complete

8 biodegradation.

9 I have one other thought that I'd

10 like to stress, is that in our submission we

11 originally brought in 12 published studies

12 dating all the way back to about 2005. 

13 Additionally, we have referenced more recently

14 European studies that go back all the way to

15 2001. So these materials and these chemicals

16 have been looked for over a decade and they

17 have demonstrated their safety in the

18 environment. 

19 So with that I'd like to thank the

20 NOSB for the time and if there are any

21 questions I'll be happy to answer them.

22 MR. FELDMAN: Thank you very much. 
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1 Questions? Zea.

2 MS. SONNABEND: Thank you. I have

3 about 42 questions but I'll start with 1.

4 MR. MOJO: I've got 8 hours. I'm

5 ready.

6 MS. SONNABEND: In our technical

7 report it was explained that there are I

8 believe four different types of materials that

9 fall under this potential category. And what

10 I'm wondering is if by the way we referred to

11 it in the name of saying bio-based bioplastic

12 or by the standards for bio-based content and

13 degradation that we adopted are we excluding -

14 - are we including all four of those types of

15 products in that annotation or are we ruling

16 out the one that started with petroleum

17 originally or any of the other ones?

18 MR. MOJO: In the petition we

19 referenced four materials, you're right. The

20 standards that we're recognizing will allow

21 all four materials because all of those

22 materials meet the specs. And understand
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1 those materials aren't necessarily used in

2 isolation with one another, but they can be

3 blended together in such a way to give the

4 properties that the farmers need so that these

5 materials can last on the fields as long as

6 they need. Does that address your question?

7 MS. SONNABEND: Okay. Yes. And

8 then how about the clause about GMO organisms. 

9 Does that affect all four of those types of

10 materials or only certain ones?

11 MR. MOJO: They would only affect

12 potentially certain ones. They wouldn't

13 affect the petroleum ones, for example,

14 because GMO has not been highlighted as part

15 of that.

16 MS. SONNABEND: Okay, thank you.

17 MR. MOJO: And there are materials

18 that can be made without GMO I believe, so.

19 MR. FELDMAN: Other questions? 

20 John.

21 MR. FOSTER: So there are

22 materials that can be made without GMOs? What
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1 does that do to the price point to the grower?

2 MR. MOJO: I don't honestly know

3 the pricing but I would -- a gentleman from

4 BioTelo is going to speak so you can certainly

5 talk to him about that. 

6 And Zea, I'll be happy to answer

7 any and all of your questions at some --

8 whenever you'd like.

9 MS. SONNABEND: And will you be

10 around the whole time if we want to call you

11 back?

12 MR. MOJO: I'm going to be -- I'll

13 be back here Thursday morning if that's all

14 right. I'll be here all day today and then

15 back Thursday morning.

16 MR. FELDMAN: Follow-up or is

17 that? Okay. Other questions? Mac.

18 MR. STONE: I'm back to my

19 semantic question of plastic. When does

20 something become a plastic versus some other

21 something that looks like plastic?

22 MR. MOJO: A plastic is a
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1 technical definition that talks about products

2 that are formed with heat. So the molding of

3 a material makes it a plastic. So cellulose

4 was the very first plastic naturally based. 

5 So plastic has -- in fact the very first

6 plastics as the USDA will tell you were based

7 on products like soybeans and used in your

8 Model A Fords. So it's -- really the process

9 of making something does not make it a

10 plastic. It doesn't necessarily have to be

11 petroleum-based. Does that help? 

12 I mean, it looks and -- I mean

13 these materials will look and feel like

14 plastic but they have different components and

15 all of those components can be consumed by the

16 microbes in the soil.

17 MR. FELDMAN: Other questions? 

18 Okay, I have a few questions. Thanks again

19 for being here. I have several questions. 

20 One goes to the international standard, what

21 Canada is doing and what your understanding is

22 about what is allowed in Canada versus what
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1 would be allowed under the annotation that has

2 been proposed, at least passed by the Crops

3 Committee.

4 And then I wanted to get a little

5 sense -- some sense from you as to the

6 different plasticizers, the PLA, what's the

7 other one, the PHA and the requirements for

8 one or other. You talk about a blending and

9 to what extent are we limited in restricting

10 the plasticizers given the necessity to blend. 

11 So let's start with those two if you could. 

12 That would be great.

13 MR. MOJO: Okay. In terms of

14 what's being done -- the European standards

15 and the U.S. standards as well as those used

16 in Canada revolve around four fundamental

17 criteria when it speaks to composting. One is

18 that the material disintegrates rapidly,

19 within a 12-week time frame. Two is it fully

20 biodegrades within 180 days and that's

21 conversion to CO2, the 90 percent number. 

22 Three is there's no ecotoxic effects from that
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1 process. And fourth, that there's regulated

2 metals levels for cadmium, chromium, and all

3 those other things that are dictated by either

4 the Code of Federal Register or the Canadian

5 authorities or the European adolescents. 

6 So those four fundamental criteria

7 are the same throughout Europe and North

8 America. There are some minor differences on

9 the metals levels based on what's regulated

10 according to the 503 sludge regs versus what's

11 done in Europe. Hopefully that addresses your

12 questions there.

13 MR. FELDMAN: To follow up on the

14 international, you're familiar with their reg

15 up there 1.4.1 which lays out the specific

16 restrictions on colorants and ingredients such

17 as GMO, et cetera. We're just -- because we

18 were told by one of the earlier presenters

19 that we were, in adopting this listing, this

20 annotation, we were bringing ourselves into

21 uniformity essentially with Canada. 

22 We're trying to answer that
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1 question, if that in fact is the case given

2 what you know about what's going on through

3 that 1.4.1 and what would be happening here in

4 the U.S. under this standard the Crops

5 Committee has proposed.

6 MR. MOJO: Well, these materials

7 are allowed in Canada and Europe today. And

8 in fact the crops that are grown in Europe and

9 Canada today can be imported into the U.S. as

10 organic today. So they compete with the very

11 same people --

12 MR. FELDMAN: So that's all the

13 four materials you're talking about.

14 MR. MOJO: Yes.

15 MR. FELDMAN: Because we haven't

16 been able to confirm that. That's why we're

17 trying to nail that down.

18 MR. MOJO: Well, to the best of my

19 knowledge absolutely. And I mean, these

20 materials are a class of material much in the

21 same way as newspaper is a class of material. 

22 I mean, newspapers differ depending on where
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1 you get them off the roll which I think gets

2 us back to why we want -- recommend changing

3 this from bioplastic biodegradable mulch films

4 to a biodegradable mulch film. Because these

5 materials perform much the same way as

6 newspaper does or craft paper does when it's

7 applied to the fields. So we see that as the

8 logical nomenclature for these types of

9 materials.

10 MR. FELDMAN: Okay. Thank you. 

11 And on the plasticizer issue, the different

12 types of plasticizer.

13 MR. MOJO: I mean, all of the

14 materials that are used in the -- all of the

15 additives that are used in these materials if

16 they're not minerals such as TiO2, all of

17 these materials, no more than 1 percent can go

18 in there and not be proven to be

19 biodegradable. So any of the additives that

20 are in there are biodegradable if they're used

21 in more than 1 percent. 

22 And there's no more than five of
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1 those additives allowed. And most people

2 don't use them. And in fact, some of the

3 materials that are used at less than 1 percent

4 may be fully biodegradable also. 

5 MR. FELDMAN: Miles.

6 MR. MCEVOY: Yes, we've asked the

7 European Commission and the Canadian Organic

8 Office to weigh in on the biodegradable mulch. 

9 And from the European Commission they're going

10 to send us a more formal reply but what they

11 said was that from what they can see it

12 appears that biodegradable mulch has not been

13 allowed to date. And they're asking their

14 colleagues for a more complete assessment.

15 The questions that they have

16 looked at is the composition and origin of all

17 components of the mulch that are not

18 mechanically removed which would, they

19 believe, have to meet the requirements in

20 their annex on fertilizer, soil conditioners

21 and nutrients that's in Article 3(1) and

22 6(d)(2) of Regulation 889/2008 as amended. So
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1 that would be that the components of the

2 biodegradable mulch would not be allowed to be

3 genetically modified. So they're going to

4 provide more information on that.

5 For the Canadian Organic Office

6 it's a much more lengthy response. They

7 reference the 1.4.1 standard that you referred

8 to. And then they have a question and answer

9 on their Standards Interpretation Committee. 

10 I can forward this onto you, Jay. 

11 Can you clarify the requirements for removal

12 of plastic mulch films. The annotation for

13 plastic mulches in Table 4.3 of the Prevented

14 Substances List is clearly intended to

15 prohibit the incorporation into the soil for

16 any material other than fully biodegradable

17 films compliant with Section 1.4.1. Where

18 there is any risk of contamination plastic

19 mulch must be removed from the soil. 

20 The distinction between annual and

21 perennial crops is made on the premise that

22 following an annual crop tillage will occur in
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1 preparation for the next year, but this

2 distinction is not essential to fulfilling the

3 intent of the standard which is to avoid

4 contamination of the soil. In situations

5 where the mulch will not be incorporated into

6 the soil then it may be left on. 

7 Are bioplastic mulches made from

8 corn accepted as fully biodegradable films as

9 the term is used in the annotation for mulches

10 Table 4.3 of the Prevented Substances List? 

11 The answer: a bioplastic mulch could be

12 accepted as fully biodegradable provided that,

13 one, the mulch is not made using GMO plant

14 material, and two, there are no substances

15 prohibited under 1.4.1 present.

16 So that's a lot of detail there

17 and I can forward this onto the board for your

18 review.

19 MR. FELDMAN: Thank you. 

20 MR. MOJO: Thank you, Miles. But

21 I do know there are materials that satisfy

22 that requirement and the gentleman from
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1 BioTelo will come forward and talk about that.

2 MR. FELDMAN: Is that your

3 understanding, Miles, that there are approved

4 materials in Canada?

5 MR. MCEVOY: Yes, it's our

6 understanding that there are approved

7 materials in Canada that are currently being

8 used.

9 MR. FELDMAN: Thank you. Other

10 questions? Comments? John.

11 MR. FOSTER: So this is more a

12 question of clarification. Hey Marty, it's

13 more of a clarification from the program. 

14 Maybe Miles. I just want to clarify something

15 you said about as long as. I think I heard

16 you say something, as long as the material is

17 not from bio?

18 MR. MCEVOY: Right.

19 MR. FOSTER: Right? So I'm

20 wondering about consistency on that from other

21 inputs that are applied to the soil that may

22 be derived from I thinking corn gluten meal
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1 for example. What's the thinking? If I heard

2 you incorrectly, tell me, but what's the

3 thinking about as long as the material is not

4 derived from genetically engineered material?

5 MR. MCEVOY: Right, that's the

6 specific reference for what they term

7 bioplastic mulches under the Canadian

8 standard.

9 MR. FOSTER: Under the Canadian

10 standard. Okay.

11 MR. MCEVOY: Right.

12 MR. FOSTER: Got it.

13 MR. MCEVOY: So we did not ask

14 them the question on GM material in general

15 but for bioplastic mulches they have a

16 specific answer for that.

17 MR. FOSTER: Okay. Then Jay, a

18 quick follow-up to that. Does anyone on the

19 board have knowledge of what Canada's position

20 is on, say, corn gluten meal with respect to

21 genetically engineered components? That would

22 be -- that would help me understand, kind of
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1 guide me a little better if we can get that. 

2 Thanks.

3 MR. FELDMAN: Others? Thank you

4 so much. And we look forward to seeing you on

5 Thursday.

6 MR. MOJO: Absolutely, and if need

7 be I'll come back tomorrow.

8 MR. FELDMAN: Okay, thank you. 

9 Dave Rogers, thank you. And let me say that

10 Eric Menard is up next.

11 MR. ROGERS: Thank you. I'm Dave

12 Rogers. I'm policy advisor with the Northeast

13 Organic Farming Association of Vermont. And

14 my comments are on behalf of NOFA Vermont and

15 Vermont Organic Farmers which is our USDA

16 accredited certifier representing 545

17 certified processors and growers or farmers,

18 including 132 certified vegetable growers.

19 We really appreciate the

20 opportunity to comment on this petition and

21 we're strongly in favor of approval of these

22 products and our farmers are as well.
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1 In Vermont as in the rest of the

2 country black plastic mulch is an important

3 production tool for a lot of growers. As you

4 well know they help warm up the cool soils in

5 spring and suppress weed growth, conserve

6 moisture. And these are all benefits to crop

7 production and marketing and really farmers'

8 bottom line as well.

9 And we regularly hear from

10 certified growers who question or oppose the

11 current rule that only allows them to use

12 petroleum-based polyethylene films or mulches

13 that have to be removed and disposed of. It's

14 costly, it's labor-inefficient and it's

15 environmentally irresponsible. Our farmers

16 really feel badly about having to do that. 

17 Dumpsters and dumpsters full being hauled off

18 to the landfills.

19 Non-certified growers I've spoken

20 with report and the literature confirms that

21 the performance of these mulch films are

22 comparable to polyethylene mulches in terms of
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1 plant growth and production, weed suppression

2 and such. These growers have found that with

3 light tilling they degrade fully with no

4 visible traces in less than a year and often

5 much less depending on soil and moisture

6 conditions. 

7 One grower with whom I had a

8 conversation yesterday talked about one

9 product he used persisted well into the second

10 year but it was gone by the end of that

11 season. And that was fine with him, it didn't

12 interfere with his farming practices.

13 So for these reasons the approval

14 of these biodegradable mulch films in organic

15 production is a big deal for many growers in

16 Vermont. And again, many of them submitted

17 written comments to that effect. And indeed,

18 like the Normans yesterday from One Straw Farm

19 we hear from farmers who choose not to become

20 certified organic because they can't use these

21 products.

22 So finally a couple of words,
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1 thoughts about degradation that sort of stem

2 from my own personal work over a number of

3 years as a microbiologist. These are simple

4 polymers really that have been shown to break

5 down fully to carbon dioxide and water and

6 microbial biomass. And I haven't seen any

7 evidence and there's no reason to think really

8 that the degradation occurring in fields is

9 any less complete. The microbes really jump

10 on this stuff. And there are dozens of

11 species of bacteria and fungi that have been

12 identified in the technical information that's

13 been submitted whose growth is stimulated as

14 they get to work on these products. 

15 As I see it there's really no

16 biochemical reason for them to stop

17 metabolizing this stuff until it's fully

18 mineralized or degraded. And of course there

19 are soil and climatic factors that affect the

20 rate.

21 For these reasons we don't see any

22 reason to think that there are stable
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1 intermediate breakdown products or residues

2 that will be produced that could be of

3 consequence and concern. And we think that

4 this recommendation should move forward. 

5 There's no reason to table it. We think the

6 information we have is sufficient to justify

7 approval. Thank you.

8 MR. FELDMAN: Thank you. Any

9 questions? Thank you very much, David.

10 MR. ROGERS: Okay, thank you.

11 MR. FELDMAN: And Eric Menard with

12 Matt Cotton on deck. Welcome.

13 MR. MENARD: Good afternoon,

14 everyone. My name is Eric Menard. I'm from

15 Canada. I'm a business development manager at

16 Dubois Agrinovation for 17 years. I'm selling

17 BioTelo mulch film everywhere in the United

18 States and Canada for the past 7 years. 

19 And everyone who use the BioTelo,

20 they never come back on plastic mulch again. 

21 They go forward with the biodegradable mulch.

22 So I'm here today to explain you
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1 much more about the BioTelo, the product. The

2 BioTelo has been first introduced in a wrap

3 about 15 years ago. It is made of Mater-Bi. 

4 It's a non-GMO cornstarch. And the film

5 degrades with the microbial activity in the

6 soil. It's very important. The sunlight

7 doesn't have any effect on the film, it's the

8 microbial activity in the ground.

9 And many study has been done on

10 BioTelo by many universities as Penn State,

11 Cornell, Tennessee, Washington State to McGill

12 in Canada and many other universities all over

13 the world.

14 So the BioTelo has the same

15 properties as the plastic mulch but the big

16 advantage is that it doesn't have to be

17 removed from the ground. So when it breaks

18 down it decomposes without leaving any

19 toxicity or residue over time. BioTelo

20 reduces the amount of CO2 per hectare of

21 mulching by over 60 percent compared to

22 traditional plastic film. So BioTelo is a
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1 great ecological and responsible alternative

2 to plastic mulch.

3 So here you can see the processing

4 of the degradation over the time for one

5 season. So you see the summer onions, you see

6 the film starting to get small holes in it. 

7 After the tillage you have very small residue

8 left in the ground. And in some case in the

9 fall you don't see anything. In early spring

10 it's practically all gone.

11 This is conventional plastic

12 mulch. The use of plastic mulch in the USA

13 exceeds 110 millions of pounds every year, and

14 it's a repeat every year. And that data comes

15 from 1987 so probably today it's more than

16 that.

17 And the plastic have been disposed

18 of routinely by burning, burial or dumping in

19 landfills. So that's what it looks like and

20 that's what I don't like to see. And I'm here

21 today to be -- to solve that big problem here.

22 And why using biodegradable? It's
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1 avoiding the soil contamination. And it's

2 certified in European region. Also, it's no

3 disposal issues. It's saving time and labor

4 a lot. Its ability to handle with current

5 commercial equipment and systems with only

6 minor adjustment. Weed suppression, water

7 retention, crop quality and yields comparative

8 to those currently provided by standard

9 polyethylene mulch film in the market.

10 The use of raw material from

11 renewable source rather than fossil fuels. 

12 Economic viability. And it's a clean and

13 innovative technology to protect our

14 environment for now and for future generation. 

15 So, I'm here today not for

16 business, for myself and for my son and for

17 the next generation. It's time to do

18 something to move and go forward with this

19 technology that exists today. And that's a

20 good alternative.

21 MR. FELDMAN: Thank you. 

22 MR. MENARD: Any question?
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1 MR. FELDMAN: Any questions? 

2 That's what I was going to say. John?

3 MR. FOSTER: So my earlier

4 question was about cost but maybe it's an

5 irrelevant question if all -- are all

6 biodegradable plastics from non-GMO sources?

7 MR. MENARD: I'm not aware about

8 too much the other kind of biodegradable but

9 I can tell you about the BioTelo. It's non10 GMO sourced. It can be done with GMO source. 

11 It will do the same material basically.

12 MR. FOSTER: But your company

13 doesn't do --

14 MR. MENARD: No, this is

15 manufactured in Italy.

16 MR. FOSTER: Okay.

17 MR. MENARD: It's not manufactured

18 yet in North America.

19 MR. FOSTER: Got it. Thank you.

20 MR. MENARD: It will be and if it

21 has to be the raw material will come from

22 Italy. 
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1 MR. FELDMAN: Go ahead.

2 MS. SONNABEND: Thank you. Do you

3 have a preference of how you think the

4 material should be referred to? I mean,

5 biodegradable mulch film versus bio-based

6 bioplastic and those type of things we

7 mentioned earlier?

8 MR. MENARD: Yes, I think because

9 this product, it's used and it's very

10 important -- I think for myself it's

11 compostable. It's the word, the terminology,

12 I think it's important in that case to be very

13 -- I think compostable, biodegradable. But

14 the word "compostable" means much more I

15 think, my point of view, of for it goes in the

16 ground, it's organic matter, and it's

17 composting inside the ground. And if it's

18 compost it means it's ecologic.

19 MS. SONNABEND: Well, so you would

20 rather not have it be called bioplastic?

21 MR. MENARD: Well, I don't like

22 the plastic. You know, I'm a guy who has been
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1 selling plastic mulch for 17 years so you're

2 talking to a plastic guy who are still selling

3 plastic mulch. But I'm convert today to the

4 compostable mulch or biodegradable mulch film. 

5 I'm not using any plastic words anymore for

6 that. So I'm convert and that's I think. 

7 And it's not only myself who say

8 that. I talk to Dr. Michael Orzolek from Penn

9 State and he say to me, and he's a plastic guy

10 like me but much older, and he say to me, he

11 say the future 20 years from now is going to

12 be biodegradable and compostable mulch film. 

13 It won't have any more plastic mulch film in

14 the industry from now, I mean in 20 years. So

15 I think compostable biodegradable mulch film

16 should be more than bioplastic.

17 MR. FELDMAN: Jennifer.

18 MS. TAYLOR: Thank you. Could you

19 please give us some information about the

20 optimal soil environment that would enhance

21 the breakdown?

22 MR. MENARD: Okay, that's a good
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1 question. The breakdown is first of all in

2 the product we have different thickness. We

3 have different thickness so the thickness

4 makes the degradation faster or longer

5 depending also the type of soil you have. So

6 more your soil have organic matter it's going

7 to degrade faster. So if it's sandy soil it

8 degrades over time but it's going to be

9 longer. But there's -- that's answer your

10 question? So the clay soil, clay will degrade

11 faster than sandy. But sandy soil will

12 eventually degrade. 

13 And the good thing of it is over

14 the years I never -- I sold over for right now

15 it's over 1,000 acres in the United States and

16 I didn't have any complaints about this

17 product. So the degradation, what we say,

18 it's what you get. So if your type of soil,

19 it's clay soil, we're going to suggest you a

20 thicker mulch so it's going to degrade after

21 the season perfectly. 

22 So that's interesting. As a
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1 product we don't have any complaint. Because

2 if I had complaint I won't be here today to --

3 talking to you about this product.

4 MS. TAYLOR: And also -- the

5 different types of varieties, or no, the

6 different types of plants that you're planting

7 would determine the thickness of the mulch

8 itself.

9 MR. MENARD: Yes. Yes, exactly. 

10 So the crops also, if it's short-term crops

11 we're going to go with thinner film. Like for

12 cucumbers we can use a 0.5 mil thickness so it

13 will last like 3-4 months under sandy loam

14 condition. So we have different -- with the

15 type of crops.

16 But obviously like strawberries

17 for 2 years that product, it doesn't last 2

18 years. The maximum we have right now, it's

19 about 1 year, one season. So we don't have

20 any product for a long term yet.

21 MR. FELDMAN: Go ahead, Harold.

22 MR. AUSTIN: You mentioned that
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1 sunlight really doesn't have an effect on the

2 breakdown of the material but its true

3 breakdown and degradation is by microbial

4 activity. 

5 MR. MENARD: Yes. The sunlight

6 effect doesn't have any impact. Basically

7 it's the warm of the soil, it does. So that's

8 make the warming the soil, but the sunlight

9 doesn't have an impact like the

10 photodegradable or the oxodegradable film. 

11 It's more with the microbial activities in the

12 ground. So you have -- that's why you have to

13 tilling the soil, the film after the season

14 and it will degrade faster. But the sunlight

15 doesn't have any impact directly.

16 MR. FELDMAN: Any other questions? 

17 Before you go could you just tell us the

18 products that are used and approved in Canada. 

19 Your product is in use in Canada? 

20 MR. MENARD: Yes, it's used in

21 Canada by the organic growers. They're using

22 it since the beginning.
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1 MR. FELDMAN: Do you know of other

2 products besides your own that are used under

3 the organic standard in Canada?

4 MR. MENARD: There's another one

5 who is approved also. 

6 MR. FELDMAN: Okay.

7 MR. MENARD: You want I give you

8 the name?

9 MR. FELDMAN: Sure.

10 MR. MENARD: It's Bio Neuve. It's

11 my competitors. It's made in France and my

12 product right now it's made in Italy. But

13 we're looking to make the product here in

14 North America, in Montreal in the near future.

15 MR. FELDMAN: Okay. Merci and ...

16 bient“t.

17 MR. MENARD: Merci beaucoup. 

18 Thank you.

19 MR. FELDMAN: I have Matt up, Matt

20 Cotton, and Kyla Smith on deck.

21 MR. COTTON: Mr. Chair, members of

22 the board, thank you very much. My name is
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1 Matt Cotton. I'm a technical consultant to

2 BPI on this issue.

3 I'm going to be brief. I'm really

4 filling in for one of our scientists who

5 couldn't be here from Italy. I do urge you to

6 positively consider the biodegradable mulch

7 petition. Although I'm not a grower I'm

8 extremely familiar with these materials and

9 biodegradable and compostable materials

10 through the work I do with composters and

11 those that buy compost. 

12 On the West Coast our biggest

13 market for compost is agriculture,

14 particularly, not exclusively, but certainly

15 organic agriculture is part of that. I

16 certainly appreciate there are lots of

17 questions and concerns and it's a confusing

18 and somewhat a magical product in a lot of

19 ways. You want it to perform exactly like a

20 plastic mulch and then somehow clap your hands

21 and have it degrade. 

22 Although I've heard a lot of
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1 testimony today I really don't hear a lot of

2 complaints from growers that it's not

3 performing although I know it doesn't work in

4 every situation. It was interesting to me

5 that we had only support from growers and no

6 opposition from growers to the petition. 

7 And it's a needed tool for

8 growers. Is it going to work in every

9 situation? No. I'm trying to anticipate

10 Jennifer's question about the types of soil

11 and there was some discussion yesterday about

12 where this is going to work and not going to

13 work. If it's not going to work for a grower,

14 maybe it's in Arizona, maybe it's too dry, too

15 hot. They're probably not going to use it. 

16 But clearly what we've heard, testimony

17 yesterday and today from growers that use it

18 is it works fine. There are some real

19 benefits to it. 

20 And ironically I think if this

21 were 20 years ago and these materials had been

22 available I think they would have been
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1 approved whereas polyethylene mulch which

2 really is a strange contradiction looking at

3 it from my outsider perspective to the organic

4 world, a bit of a contradiction that that's

5 allowable compared to these. 

6 In certain places obviously the

7 growers and the certifiers will figure out the

8 best management practices. Obviously this

9 will be part of a crop plan reviewed by the

10 certifiers. I understand there's some

11 questions there. We've worked to try to

12 address those. I believe it's quite clear

13 there's adequate and sufficient data to

14 determine that there are no negative soil

15 impacts of these materials. 

16 More study is -- what is needed

17 and ironically if we approve, if you see fit

18 to approve these materials there will be study

19 because that's how it goes. We don't have a

20 lot of history of using these materials

21 because they're not allowed. And the

22 professors I work with like to use materials
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1 that people are actually using so their

2 research has benefits. Field experience will

3 continue to inform best practice. 

4 And getting to the question, the

5 linguistic question to some extent, I believe

6 biodegradation should be seen as a type of

7 removal. I think we're living in a fantasy

8 world if we think that 100 percent of all the

9 polyethylene mulch that's used in fields is

10 removed. Biodegradation is a much more

11 efficient of removing, truly removing these

12 materials from that environment. 

13 Ask any farmer, ask the folks from

14 NOFA Vermont, anyone who's used these

15 materials in the soil how well that material

16 is removed, how completely polyethylene mulch

17 gets removed from the soil after a year of

18 being on a crop in the sun. I think you'll

19 find that there's -- hard to find a place that

20 uses that mulch that doesn't have little

21 shards of plastic throughout the soil and that

22 could be studied.
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1 Fundamentally the use and

2 certification to ASTM standards is something

3 that we work with in the composting industry. 

4 We're already comfortable with it. We've used

5 the ASTM standards and we think that's a good

6 way to go.

7 With that I'd be happy to answer

8 any questions.

9 MR. FELDMAN: Thank you. 

10 Questions? Mac.

11 MR. STONE: How fast is

12 conventional growers adopting this technology?

13 MR. COTTON: I'm sorry?

14 MR. STONE: How fast are

15 conventional growers adopting this technology?

16 MR. COTTON: That's a great

17 question for Eric. I don't know.

18 MR. FELDMAN: Other questions? 

19 Okay, Zea.

20 MS. SONNABEND: My question which

21 sort of just occurred to me now I might not be

22 able to word in the right way. But in reading
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1 the European studies, the one from Italy

2 particularly they tested biodegradable row

3 covers as well as mulch films. And the row

4 cover is biodegradable but it will last long

5 enough in a season, but then of course as a

6 row cover you would remove it and

7 theoretically compost it. Are there issues

8 there or would it be okay to compost it

9 because you're assured by the same ASTM

10 standards that a row cover would also degrade

11 in composting.

12 MR. COTTON: That's a great

13 question. To be fair I don't have the

14 experience to answer that question. I believe

15 the gentleman who testified earlier from

16 upstate New York does some row tunnel growing

17 and composts that material on the farm for use

18 on the farm. So actually I would guess these

19 materials would compost quite readily. Eric

20 had some samples. I hope he passed them

21 around. 

22 It's a relatively thin material. 
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1 And you may have heard there is some

2 controversy of some of the compostable stuff,

3 maybe you've seen it in the cafes around here,

4 as you get to bigger and bigger thicknesses. 

5 But almost every composter will say the bags

6 work just fine. So thin sheets of this stuff

7 allow a lot of surface area for microbes to

8 attack that. So I have not heard of any

9 issues with that whatsoever. It composts

10 great.

11 MR. FELDMAN: Questions? Are you

12 able to tell us what the time to degradation,

13 complete degradation is?

14 MR. COTTON: No. That's a

15 question -- we can certainly -- I can

16 absolutely get you that answer.

17 MR. FELDMAN: Okay.

18 MR. COTTON: I think that will

19 vary to some extent clearly by the thickness

20 and to some extent material by material. But

21 I'm sure we can provide that, be happy to.

22 MR. FELDMAN: Okay, thank you. 
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1 Thanks a lot. 

2 MR. COTTON: Thank you.

3 MR. FELDMAN: Kyla Smith. And we

4 have Jim Munger on deck.

5 MS. SMITH: Okay, good afternoon. 

6 My name is Kyla Smith. I am the certification

7 program director for Pennsylvania Certified

8 Organic. PCO is an NOP-accredited non-profit

9 certifying agent that certifies about 650

10 operations in the mid-Atlantic region. I'd

11 like to comment on the recommendation to add

12 biodegradable mulch film made from bioplastics

13 to the National List.

14 PCO does not have a position for

15 or against this specific material. We realize

16 the desire for farmers to want more options

17 for weed control. However, the current

18 version of the recommendation prevents

19 challenges for certifier verification. 

20 It is difficult to enforce parts

21 of the regulations, including annotations that

22 leave room for interpretation among producers
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1 and certifiers. We recognize that there will

2 be changes to the annotation prior to voting.

3 PCO asks that you consider the

4 following requests for clarification to

5 provide clear measurability by certifiers, to

6 ensure compliance of farmers' organic system

7 plans with the USDA organic regulations. We

8 hope these comments prove useful in your

9 deliberations.

10 The current recommendation defines

11 biodegradable mulch film as showing at least

12 90 percent biodegradation absolute or relative

13 to microcrystalline cellulose in less than 2

14 years and simultaneously requires the grower

15 ensures complete degradation at the end of

16 each growing or harvest season. That is

17 consistent with Section 205.206(c)(6) which

18 requires that plastic or other synthetic

19 mulches be removed from the field at the end

20 of the growing or harvest season. 

21 We appreciate the clarification

22 regarding the intent of portions of the
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1 annotation were specifically included for MROs

2 and certifiers to evaluate these materials as

3 opposed to the portions that were specifically

4 included for producers.

5 The question still remains that

6 since this is a synthetic material it must be

7 removed from the field at the end of the

8 growing or harvest season, and we are seeking

9 further clarification on how we are to enforce

10 that when typically growing or harvest seasons

11 are less than 2 years and this material could

12 take up to 2 years to biodegrade. Guidance

13 for certifiers to verify that growers have

14 taken measures to ensure complete degradation

15 annually is crucial for consistency throughout

16 the organic industry. 

17 Instead of removal from the field

18 the subcommittee's recommendation requires

19 that synthetic bioplastic degrades by the end

20 of the growing or harvest season. If the

21 subcommittee's recommendation infers that

22 degradation equals removal this needs to be
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1 more clearly stated.

2 We encourage the board to ask the

3 program to develop guidance that will provide

4 further clarification to certifiers and

5 producers regarding the following. What does

6 complete degradation mean and how is complete

7 degradation expected to be verified? By

8 visual confirmation or testing by the

9 certifier, inspector or producer? If the

10 expectation is that the inspectors will verify

11 complete degradation of the product this may

12 not be able to be verified until the following

13 year as many inspections occur prior to the

14 end of the growing season.

15 We also support the idea of the

16 development of a certification program to the

17 ASTM standards. This will assist MROs and

18 certifiers that may not have the expertise to

19 make these determinations without additional

20 time and resources.

21 Lastly, the technical evaluation

22 report highlights several sub-ingredients like
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1 titanium dioxide and carbon black that are

2 used in the production of biodegradable mulch

3 film. In future production there could be

4 other pigments that are used and these could

5 potentially be synthetic. 

6 We appreciate the clarification

7 that was provided during the subcommittee's

8 presentation that stated if other synthetics

9 are present in future formulations these must

10 be specifically petitioned for inclusion on

11 the National List. 

12 PCO is unclear if there are

13 synthetic forms of titanium dioxide that are

14 used in biodegradable mulch materials. We

15 understand that titanium dioxide is a mined

16 mineral. However, it may undergo synthetic

17 processes. As a certifier that does material

18 review it is critical that the addition of any

19 synthetic materials to the National List is

20 restricted in the same and consistent manner

21 as similar materials already listed on the

22 National List.
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1 PCO needs to know if it is our

2 responsibility to confirm if a sub-ingredient

3 such as titanium dioxide is mined. 

4 Restrictions such as this are typically

5 annotated. PCO supports putting tools in the

6 farmer's toolbox. However, we must do so in

7 a consistent and clear manner. We think it's

8 imperative that the board must address these

9 concerns. And thank you for your time and

10 effort.

11 MR. FELDMAN: Thank you. 

12 Questions? Zea.

13 MS. SONNABEND: Thank you for that

14 input. If you heard us this morning, I'm sure

15 you did, the direction that we are going is

16 trying to have separate sets of the annotation

17 that are oriented for growers and certifiers,

18 and oriented for MROs. 

19 If we put the onus of assuring

20 complete degradation onto the MRO side of the

21 equation so to speak so that before the

22 product is approved we have to know that in
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1 the right conditions they sufficiently break

2 down. Then all the certifier's role would be

3 is to verify that the appropriate actions as

4 spelled out in the guidance had been taken to

5 assure that it is breaking down in the field. 

6 And then one of the ways of verifying that

7 would be to look at the field and see if it

8 hadn't really been broken down and then to see

9 what appropriate actions. 

10 We feel this is somewhat more

11 consistent with a process standard approach to

12 the whole thing. I'm wondering do you feel

13 okay with that if that's the way that we're

14 going.

15 MS. SMITH: We totally support a

16 process-based standard. I think clarification

17 -- inspectors may view "complete" differently

18 and so if they are onsite evaluating a field

19 I may, I don't know, see little bits or a few

20 bits here and there and may evaluate that

21 differently than a different inspector. So I

22 think that further clarification in that
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1 regard may be helpful.

2 MS. SONNABEND: Okay. They would

3 not have to evaluating complete. They would

4 have to be evaluating appropriate and then

5 just reporting on what they saw in the field.

6 MS. SMITH: Yes, that would be

7 helpful. 

8 MS. SONNABEND: Okay.

9 MS. SMITH: We would -- we would

10 be down with that.

11 MR. FELDMAN: Other questions? I

12 had a question about your comment in your

13 written testimony about essentiality which I

14 found interesting. Could you tell us where

15 you think this decision or what factors you

16 think should be brought to the question of

17 essentiality of this material in organic

18 systems?

19 MS. SMITH: I didn't write the

20 written comment. Our policy director did and

21 she's not here so I'll try to address that

22 from conversations with her.
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1 We, most of our producers that

2 obviously use the black plastic and we

3 understand that there's a concern that it does

4 end up in landfills. We do have extensive

5 lists of recycling centers that we have found

6 that take the plastic. I don't know what

7 happens to it after they take it. And so we

8 haven't had a big outcry from our producers to

9 use this product. We've had a few requests. 

10 So in regards to whether or not our producers

11 find it essential I'm not sure. I don't know

12 if that really answers your question very

13 well.

14 MR. FELDMAN: Thank you. Thank

15 you very much. 

16 MS. SMITH: Thanks.

17 MR. FELDMAN: Jim Munger, is he? 

18 Thank you. And Lindsay Fernandez-Salvador is

19 up next.

20 MR. MUNGER: Hello, I'm Jim

21 Munger. Being here reminds me of coming here

22 in 1970. I had just celebrated the first
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1 Earth Day at the University of the Pacific and

2 came to Roger Williams University and taught

3 environmental chemistry for 30 years. I'm now

4 a farmer and growing things primarily by

5 hydroponics.

6 I'm a member of the Cornucopia

7 Institute and here as a citizen lobbyist. I

8 know that "lobbyist" can sometimes be sort of

9 a dirty word but I guess it's a necessity to

10 make sure that we get all sides of the

11 positions.

12 I'll talk today about four

13 materials, ferric phosphate, oxidized lignite,

14 propylene glycol and rotenone. I have grown

15 chrysanthemums and rotenone is actually made

16 from chrysanthemums.

17 Ferric sulfate, we support the

18 proposal to remove ferric sulfate from the

19 list of synthetic substances allowed for use

20 in organic crop production. Ferric sulfate --

21 phosphate currently is allowed to be used to

22 kill slugs.
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1 All commercial products that

2 contain ferric sulfate also include EDTA. 

3 Ferric phosphate was initially allowed because

4 EDTA was considered an inert ingredient. The

5 recent reviews suggest that EDTA is not inert

6 and is required to ensure efficiency of the

7 product.

8 This indicates that EDTA must be

9 evaluated as an active ingredient. Previous

10 NOCSB reviews of ferric phosphate with EDTA

11 have shown that EDTA may be harmful to the

12 environment, EDTA may persist in the

13 environment and that EDTA has potential for

14 mammalian toxicity. Products containing

15 ferric phosphate with EDTA should be

16 prohibited.

17 Oxidized lignite. Cornucopia

18 recommends that you reject the proposal to

19 allow hydrogen peroxide-extracted humic acid

20 derivatives, also called oxidized lignite. 

21 These humic acids are a product of coal-mining

22 which is harmful to the workers and the
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1 environment. The TER stated that these coal

2 derivatives may be toxic. The manufacturing

3 process is not known because it was removed

4 from the petition. 

5 Most important, synthetic humic

6 acids are not essential. The same humic acids

7 can be added to the soil through natural

8 methods such as mulches, compost or cover

9 crops.

10 Propylene glycol monolaurate

11 (PGML). Cornucopia recommends that you reject

12 the proposal to add propylene glycol

13 monolaurate to the National List. PGML was

14 petitioned for use as a miticide although it

15 has broad-spectrum activity against mites,

16 fungi and bacteria. 

17 The broad-spectrum activity can

18 reduce biodiversity. Organic farmers have

19 found that maintaining a diverse, balanced

20 ecosystem approach to guideline will prevent

21 or minimize mite damage on their crops. A

22 broad-spectrum miticide is not only
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1 unnecessary but actually upsets the balance of

2 the ecosystem.

3 And I make a comment on rotenone,

4 and basically we are suggesting that rotenone

5 be prohibited as a natural substitute. I

6 heard the bell so I --

7 MR. FELDMAN: Yes.

8 MR. MUNGER: -- it up.

9 MR. FELDMAN: Unfortunately. 

10 Thank you very much. Any questions? Thank

11 you, sir. Lindsay, you're up. And on deck

12 is, excuse me, Bill Wolf is on deck. Thank

13 you.

14 MS. FERNANDEZ-SALVADOR: Good

15 afternoon, I'm Lindsay Fernandez-Salvador from

16 OMRI. I'd like to focus the majority of my

17 comments today on the biodegradable mulch

18 films.

19 We sincerely appreciate the

20 subcommittee's serious consideration of our

21 comments, our written comments. Much of our

22 concerns were addressed in the subcommittee's
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1 presentation of these materials. Thus I want

2 to spend some time here indicating to the NOSB

3 what we agree with to this point and what

4 continues to need further clarification and

5 consideration.

6 For the definition of

7 biodegradability we understand that the ASTM

8 6400 is a standard that serves two purposes,

9 both a practical one for the mulch

10 manufacturer to be able to test on a shorter

11 time frame whether it's worth it to pursue

12 certification to the ASTM 5988 and as a test

13 for ecotoxicity of the components as they

14 degrade in a composting condition.

15 We did question the need for

16 verifying both standards for our purposes but

17 accept this explanation going forward. The

18 one thing I would suggest, however, is to make

19 sure that the subcommittee and the NOSB in its

20 entirety fully understands this argument and

21 evaluates if indeed the certification to ASTM

22 6400 is needed for verifying the intent of the
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1 NOSB's requirements for the allowance of these

2 films. 

3 We are happy to see the

4 clarification that you intend to require third

5 party certification to the various standards. 

6 Although OMRI could verify the various

7 standards independently it would not make me

8 happy to have to do so.

9 In regards to the clarification

10 for excluded methods and the use of them in

11 the source and manufacture of such substances

12 we appreciate the clarification that it is the

13 intent to prohibit the use of excluded methods

14 in the organisms or microbes that may carry

15 out the manufacture of these biodegradable

16 plastics. 

17 This clarification offered in the

18 presentation concurs with OMRI's policy on the

19 use of GMOs in input products. We're up to

20 date with advances in this technology and it

21 does include GMO microbes that produce

22 biodegradable plastics in their cell walls so
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1 it will potentially become a reason for

2 denying OMRI listing in the future.

3 A few clarifications. We're

4 concerned about the additives in the mulch

5 films. My previous research indicates that

6 patents for mulch films include other types of

7 additives such as colorants like red

8 colorants, resins to prevent breakdown,

9 fungicides, et cetera. So, we're concerned

10 about whether or not the intent is to limit it

11 to both carbon black and titanium dioxide, or

12 that we would allow any other additives that

13 might come in future petitions or future

14 products. 

15 And finally we want the

16 subcommittee to clarify that by indicating

17 that the mulches should be bio-based that

18 those biodegradable plastics created by

19 microbes are included or excluded from this

20 definition. The subcommittee's recommendation

21 indicates that bio-based is organic material

22 in which carbon is derived from a renewable
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1 resource via biological processes. So does

2 this definition for you include bioplastics

3 made by microbes fermenting on methane gas

4 generated from food waste or plant-based

5 media? We'd like to understand more about

6 your understanding of bio-based.

7 We know this is a complicated

8 issue. The petition was very thorough but my

9 experience indicates the technology for

10 bioplastics is moving fast and becoming more

11 innovative. OMRI's goal is to ask the

12 question as to whether the NOSB has all the

13 information about what's coming in this

14 technology.

15 We are concerned that there will

16 be a pressure on OMRI to prove any and all of

17 these materials because there is such a huge

18 demand for them. Thank you.

19 MR. FELDMAN: Thank you. 

20 Questions? John.

21 MR. FOSTER: If I had all the

22 information about all the products that might
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1 be coming down the pipeline I'd be in a

2 totally different line of work. So given that

3 we will not have that information, we just, we

4 won't, ever, what's the best you see we can do

5 with the information we are likely to be able

6 to have? Because we won't have it all, we

7 never will. So what's the best we can do with

8 what we have? In that regard. You know,

9 preparing and gathering information, what do

10 you --

11 MS. FERNANDEZ-SALVADOR: Totally.

12 MR. FOSTER: -- yes.

13 MS. FERNANDEZ-SALVADOR: Well, I

14 would look at the current technologies right

15 now. The petition outlines several different

16 types of biodegradable plastics that are out

17 there. So I would first go to that and I

18 would make sure that you all understand what

19 those technologies are and understand what

20 you're approving. 

21 I would go back to the source. Do

22 you care about that it's made from cornstarch? 
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1 Do you care that it's made by a microbe on

2 fermentation? These are the things that we

3 want to understand from you.

4 We also want to understand whether

5 or not the additives that are declared in the

6 petition are the only additives that you are

7 going to allow or want to allow. Because

8 going forward we know that manufacturers will

9 put more things because it enhances their

10 product. So we just need to know based on the

11 information that you have today what you're

12 limiting it to and what you're not limiting it

13 to.

14 MR. FELDMAN: Thank you. Zea?

15 MS. SONNABEND: Thank you,

16 Lindsay. I'd like you to help me understand

17 your comment about the "bio-based" word. Was

18 it sort of -- was it similar to my question

19 from the BPI gentleman about whether bio-based

20 would include products that had originally

21 stemmed from petroleum versus plant materials,

22 or is it a different point than that?
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1 MS. FERNANDEZ-SALVADOR: No. My

2 main concern here is that there's

3 biodegradable plastics that are derived with

4 feedstocks from plant materials and then

5 there's also biodegradable plastics that are

6 derived by microbes through fermentation of

7 methane gas from food waste facilities and/or

8 plant media. 

9 And so my understanding is that

10 the test that the petitioner proposed for this

11 would test that it was in fact bio-based. But

12 I wanted to understand whether or not you guys

13 understood what bio-based was and if your

14 intent was just that the feedstocks need to be

15 bio-based or if it can also be created by a

16 microbe via fermentation.

17 MS. SONNABEND: I don't recall

18 seeing the methane gas origin in our petition

19 or TR.

20 MS. FERNANDEZ-SALVADOR: Right. 

21 And so this is where I introduce other

22 technology that's out there. I attended a
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1 presentation by a company that was developing

2 this as we speak so that's where I was trying

3 to seek clarification.

4 MR. FELDMAN: Questions? Has OMRI

5 been asked to approve this material up to this

6 point?

7 MS. FERNANDEZ-SALVADOR: No.

8 MR. FELDMAN: Okay. Okay, thank

9 you, Lindsay. Another question.

10 MR. FOSTER: To what extent do you

11 feel it's necessary to address the GMO issue

12 on this material relative to the greater

13 context of GMO policies kind of already in

14 place? And I'd also be interested, if NOP has

15 a thought on that I would be interested in

16 that too. But I want to hear what you have to

17 say.

18 MS. FERNANDEZ-SALVADOR: Sure. 

19 Well, that same presentation that I attended

20 where the microbes were in fact creating the

21 biodegradable plastics in their guts, in their

22 cell walls, the presenter indicated that there
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1 were GMO microbes being developed that could

2 produce them faster with different properties. 

3 And according to our current OMRI

4 policy we would not allow biodegradable

5 plastics from that type of genetically

6 modified microbe, the same as we wouldn't

7 allow citric acid derived from genetically

8 modified aspergillus. So I think what has

9 been presented by the subcommittee and what I

10 understand as the changes would then come in

11 concurrence with OMRI's current policy. 

12 So we would -- we do understand

13 that genetically -- cornstarch from, for

14 example, genetically modified corn would be an

15 allowed feedstock and that would also be in

16 concurrence with our current policy.

17 MR. FELDMAN: Do you want some

18 clarification from the program?

19 MR. FOSTER: If they're

20 interested. I would be interested in hearing

21 the relative need to review or to consider the

22 GMO issue with respect to this material given
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1 that there's a larger context of excluded

2 methods. That's what I was interested in. Do

3 we need to do it now would be one way of

4 asking that question. 

5 MR. FELDMAN: Should we postpone

6 that till later? Because we'll be back at

7 this.

8 MS. BAILEY: Was there a question

9 in there? I thought that was more of a

10 statement.

11 MR. FELDMAN: He's looking -- he's

12 desperately looking for advice.

13 MR. FOSTER: Well, I'm -- what I'm

14 interested in is what is the perceived need to

15 deal with GMO issue with regard to this

16 specific material given that there is a

17 larger, more what I would consider broader

18 scope approach to GMOs that's evolving and I

19 think getting more refined. But what is the

20 need to do it within the context of this

21 material deliberation.

22 MR. MCEVOY: Okay, so the question
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1 is should you deal with it now or later. We

2 would like a consistent approach to how you

3 look at 205.105, the excluded methods, what's

4 the use of excluded methods. When is it a use

5 of excluded methods and when it is not.

6 And in the past the NOP in the

7 questions and answers said that GM crop

8 residue, GM soybean meal as a fertility input

9 was not a use of an excluded method. We don't

10 have those questions and answers up anymore

11 but we're looking for the board to take a look

12 at this through the GMO Ad Hoc Committee and

13 provide us with a recommendation. 

14 So a consistent approach to

15 looking at those types of substances and how

16 they're used or not used in organic

17 agriculture is what we would like to see, a

18 consistent approach. And you have a substance

19 in front of you that you're taking a look at. 

20 So you have to make a determination of whether

21 it makes sense to wait and do it as a group or

22 to look at it on a case-by-case basis.
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1 MR. FELDMAN: Thank you. Other

2 questions? Lindsay, one quick question on

3 ASTM 6400 and the ecotoxicity testing. How

4 does that align with the board's

5 responsibility to evaluate long-term or short6 and long-term effects on ecotoxicity, on

7 ecosystems.

8 MS. FERNANDEZ-SALVADOR: OMRI's

9 responsibility?

10 MR. FELDMAN: Well, the board, as

11 you would see the board in doing its review

12 before listing something. 

13 MS. FERNANDEZ-SALVADOR: Oh. 

14 Well, in relation to my comment there what I

15 was really getting at was that because OMRI is

16 going to have to verify this. So we're going

17 to have to get two different certificates for

18 6400 and 5998. 

19 My initial understanding was that

20 6400 was really a test for the manufacturer to

21 make sure that they're going to get through

22 the 2-month period of time in a composting
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1 facility and that would indicate to them

2 whether or not it was worth it to pursue the

3 5998.

4 And for OMRI I would prefer not to

5 have to verify two standards if I can only

6 verify one. But I understand now that 6400

7 tests both the threshold on timing and also

8 ecotoxicity. So if you feel that is

9 beneficial and you understand that 6400 in

10 fact does something for the NOSB in their

11 review of it and the effectiveness and its

12 effect on the environment then we accept that

13 argument and we're happy to verify that as

14 well.

15 MR. FELDMAN: Are you familiar

16 enough with the ECOTOX review?

17 MS. FERNANDEZ-SALVADOR: That's

18 the first time I'd heard of it.

19 MR. FELDMAN: Okay, thank you. 

20 Thank you very much. Bill Wolf is up and on

21 deck is Pam Coleman.

22 MR. WOLF: Hi. I haven't been in
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1 front of the board in 2 years and you guys

2 have been doing some great work. I appreciate

3 the opportunity to be here. 

4 I'm Bill Wolf with Wolf DiMatteo &

5 Associates. I'm an organic advocate, a

6 farmer, a gardener for 40 years and been

7 involved in organic inputs as well.

8 Regarding mulch film our initial

9 client was Joan and Drew Norman of One Straw

10 Farm as actually as a pro bono support for

11 their efforts, later joined by the

12 Biodegradable Products Institute. And I'm

13 making that statement for transparency

14 purposes.

15 However, as I became involved in

16 looking at this material I actually was a

17 little skeptical and became more and more

18 convinced that it was a useful tool for

19 organic farmers.

20 In 2002 at the first NOSB meeting

21 20 years ago I presented the OFPANA guidelines

22 for organic production as one of the tools for
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1 this board to consider in establishing

2 standards and materials review processes. 

3 At that time we were all talking

4 about how the standards need to be easy to

5 understand and encourage conversion of more

6 acreage. Organic practices should encourage

7 an increase in earthworms, improve food

8 quality, biodiversity in the environment and

9 help farmers, eaters and the planet.

10 I thought at that time that

11 organic acreage would be over 10 percent by

12 2010 and we even discussed those kinds of

13 goals 20 years ago. But today it's only 1

14 percent worldwide. We have to ask ourselves

15 why and what we can do about it.

16 Today a number of organic farmers

17 are leaving organic, especially the smaller

18 farmers. It has become very complicated and

19 very prescriptive and not very friendly for

20 the smaller farmers. There is a risk that

21 organic may have peaked in some markets and in

22 some uses. 
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1 Contentious debate rather than

2 consensus-building is now the norm internally. 

3 Decisions about what materials should be

4 allowed have always been controversial. 

5 On your screen there's a slide

6 that talks about the roots of organic

7 regulations, showing that really we began with

8 the soil. A lot of the principles behind the

9 decisions about organic regulations I jokingly

10 and perhaps not so jokingly say, you know,

11 think like an earthworm when you're making

12 some of these decisions.

13 Decisions about materials not only

14 have been controversial but we have to look at

15 the broader picture. It is useful and needed? 

16 Is it better than currently available tools? 

17 Is it okay with the earthworms and the

18 beneficials? Let's apply common sense and

19 work together for continuous improvement.

20 Organic was an agricultural

21 standard built from a philosophy rooted in

22 good soil management, not based solely on what
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1 the consumer expected who are often influenced

2 by simplified messages from organizations and

3 businesses. 

4 On your screen right now are

5 slides from One Straw Farm's use of

6 biodegradable mulch. And I think we did a

7 good job, one of the things I'd like you to

8 consider is that I think we did an excellent

9 job establishing these overarching principles

10 in a system of having an organic system plan

11 and the expectation that inspections verify

12 that farmers are protecting the soil. Let's

13 let that system work rather than being overly

14 restrictive.

15 Here's biodegradable mulch broken

16 down within the same season on One Straw. And

17 here's some of the language about the OSP and

18 farm practices that really manage the process. 

19 Remember that growers have to oversee the soil

20 and improve the soil, and that's the case. So

21 please consider biodegradable mulch and

22 approve it. There's a number of bullet points
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1 there on the screen that you've heard about. 

2 I'm running out of time here so thank you for

3 your time and your efforts.

4 MR. FELDMAN: Thank you. 

5 Appreciate it. Any questions from the board? 

6 Yes, Wendy.

7 MS. FULWIDER: You made a lot of

8 points about farmers leaving organic and

9 that's certainly been part of the trend,

10 especially with grain farmers. Could you give

11 us some tips on how to make things a little

12 easier to keep farmers in organic and to

13 attract more farmers?

14 MR. WOLF: Well, the areas where I

15 especially see people departing who have been

16 certified are smaller farmers who are doing a

17 good portion of their farming and marketing in

18 local and direct CSAs, farmers markets. I've

19 probably been to 20 farmers markets in the

20 last 2 years where most of the farmers are no

21 longer organic, many of whom I knew and used

22 to be and have just said, you know, the
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1 constant doubt of what I'm doing on my farm

2 and all the paperwork has become somewhat

3 overwhelming. And I've met a number of

4 farmers who are also using biodegradable film

5 and saying I got out, I liked it, I'm not

6 using it -- I mean, I'm not going organic. 

7 I think there's -- actually

8 there's probably 10 things that we as a

9 community need to look at doing to encourage

10 more acreage. And part of it's education,

11 part of it's research and the research

12 priorities that you are all talking about

13 setting is really important. I think that at

14 the extension level we've seen shift but not

15 as much shift as we need. 

16 But I also think that looking at

17 the regulations in terms of being excessively

18 prescriptive is a piece of it. When you

19 mentioned dairy farmers, I know dairy farmers

20 who have looked at -- the pasture rule has

21 actually had a negative influence on some of

22 the smaller farms because they were used to
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1 the concept of pasture but they didn't keep

2 track of how many grains of grass. 

3 So we get into zero tolerance

4 situations, in other words, we have an

5 incident where there's one bad apple and then

6 we lay down a rule. And I'm not criticizing

7 the pasture rule, I think it was progressive

8 to address those issues of potential CAFOs. 

9 But when we deal with a single incident by an

10 umbrella that affects and comes down on

11 everyone it negatively affects the community

12 in many ways. So that's a very good

13 discussion item long-term.

14 MR. FELDMAN: Thank you. Any

15 other questions? Thank you, Bill. 

16 MR. WOLF: Thank you.

17 MR. FELDMAN: Pam Coleman is up

18 and Walter Talarek is on deck.

19 MS. COLEMAN: Good afternoon. My

20 name is Pamela Coleman. I'm a farm policy

21 analyst for the Cornucopia Institute. I'm a

22 scientist with a master's degree in vegetable
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1 crops, a Ph.D. in plant pathology. I'm also

2 a former inspector and reviewer notably for

3 WSDA.

4 We'll have a slight change of

5 topic because I'd like to congratulate the

6 Crops Subcommittee for developing such a clear

7 and comprehensive proposal for the review of

8 inerts ingredients from EPA Lists 3 and 4. 

9 Cornucopia supports this proposal

10 and we believe that the NOSB should expedite

11 the review of these List 3 and List 4 inerts. 

12 We'd like to see the review of inerts be given

13 even higher priority than the review of new

14 materials and we're hoping the NOP can support

15 the project.

16 And now back to bioplastic. We

17 also appreciate the work that you've done on

18 bioplastic mulches. The promise of this

19 biodegradable plastic to warm soil and control

20 weeds makes it tempting to approve these

21 materials soon. The challenge though is to

22 verify that they truly are biodegradable and
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1 that they don't leave harmful residues in the

2 soil. 

3 Cornucopia is requesting that this

4 petition be tabled until the bioplastics can

5 be thoroughly evaluated. The TER was dated

6 August 2, the proposal completed August 15. 

7 Yes, the NOSB is a great group but given the

8 challenging technical nature of the review

9 materials we'd like to see that more time is

10 available for all of us to fully evaluate

11 these materials, and especially the breakdown

12 products.

13 You'll notice that I'm calling

14 them bioplastics, not biodegradable, and

15 that's because the petition itself calls them

16 bioplastics. We at Cornucopia are not

17 convinced that they're biodegradable to the

18 degree that is consistent with organic

19 principles, that is to maintain or improve the

20 quality of the soil. 

21 The TER also raises concern about

22 the biodegradability in seven different
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1 places. I don't have time to read them all

2 but certainly you can ask me more about them

3 in the question and answer period.

4 I would like to read one, though,

5 line 649 from the TER. "Comprehensive studies

6 were not found that described the

7 environmental impacts of the use of bioplastic

8 mulch. Due to the wide variety of potential

9 chemicals released from incomplete degradation

10 of bioplastics this is a data gap."

11 The Crops Subcommittee agreed it

12 might be difficult to separate claims from

13 truth concerning biodegradability. In short,

14 it's clear that synthetic chemicals are used

15 in the manufacture of bioplastics. Therefore,

16 there's a possibility for residues of

17 synthetic chemicals in the soil even after the

18 mulch appears to have degraded. 

19 We'd like to see each of these

20 types being reviewed individually and we think

21 that might shed more light on the products of

22 degradation and perhaps clarify things. 
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1 Please table this petition and I thank you for

2 your attention.

3 MR. FELDMAN: Any questions from

4 the board? Pamela, I'll quickly ask you, you

5 identified data gaps that were identified in

6 the TR. What area -- can you just briefly

7 tell us where those are?

8 MS. COLEMAN: Okay. Do you want

9 me to just read the lines or read the quotes?

10 MR. FELDMAN: Well, if you could

11 read the -- yes, read the quotes quickly if

12 you can. 

13 MS. COLEMAN: I'll talk fast and

14 abbreviate. Line 421, "Erucamide binds

15 strongly to soils and sediments in water and

16 is likely to bioconcentrate in aquatic

17 organisms."

18 Line 445, "Studies were not found

19 that specifically assessed ecotoxicity of

20 bioplastics following degradation in the soil

21 and a better understanding of bioplastic

22 degradation is needed."
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1 Line 488, "AAC" -- that's the

2 aliphatic aromatic copolymer -- "may leave

3 residues of synthetic chemicals." 

4 Line 592, "Researchers have argued

5 for more extensive research into the

6 biodegradation pathways of the various

7 bioplastics."

8 Line 595, "Due to the diversity of

9 bioplastics currently being developed testing

10 is necessary to determine which polymer

11 mixtures are degraded completely and what

12 effects incomplete degradation may have on the

13 agro ecosystem."

14 Line 649 I've already read. Line

15 652, "Reports have shown that bioplastics

16 containing terephthalic acid at concentrations

17 over 50 percent do not completely biodegrade

18 in soil."

19 I will say I noticed that Zea

20 mentioned some studies from Europe. I did not

21 see a scientific citation on that and I would

22 -- I believe that's another reason why we
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1 should table this until she can give us the

2 citation and allow the scientific community to

3 review that additional information. 

4 MR. FELDMAN: Thank you. Any

5 other questions? Thank you very much. 

6 MS. SONNABEND: We did only get

7 those European studies about 3 or 4 days

8 before the meeting. They will be posted to

9 the docket I believe after the meeting is over

10 because they were part of the testimony that

11 was put in today by BPI. And one of the

12 studies has a lot of other citations to

13 further research that we have not had a chance

14 to dig up and look at.

15 MR. FELDMAN: Thank you. Thank

16 you, Pam. Walter Talarek and David Moore is

17 up next.

18 MR. TALAREK: Good afternoon. My

19 name is Walt Talarek and I'm here representing

20 the W. Neudorff company of Emmerthal, Germany. 

21 Neudorff is a very small family-owned and

22 operated producer and registrant of pesticide
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1 products most of which are considered by EPA

2 to be low-risk pesticides. And many of these

3 registrations that it owns are for products

4 that are approved for NOP and OMRI claims and

5 logos.

6 Two of these products that are

7 approved for NOP and OMRI claims are Sluggo

8 and the slug -- I'm sorry, the Bug-N-Sluggo

9 products. Both of these products contain

10 ferric phosphate as an active ingredient. 

11 Back in 2008 Steptoe & Johnson

12 initially submitted its petition to de-list

13 ferric phosphate from the National List. That

14 petition was subsequently modified in 2009. 

15 And since that time over the last few years

16 Neudorff has both testified at a couple of

17 these meetings and submitted on numerous

18 occasions to the docket its scientific

19 information and objections to the Steptoe

20 petition.

21 Just recently the Crops

22 Subcommittee came out with a recommendation to
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1 reject the Steptoe petition. I'm here today

2 to say that Neudorff the Crops Committee's

3 recommendation. The rationale provided

4 therefore we fully support. 

5 And further, we would like to

6 thank the board, the full board, for going

7 back per our request and requesting a

8 supplemental technical report on this

9 petition. And we might note that that

10 petition included most of the scientific

11 information that we submitted but not all of

12 it. And I'll make a couple of comments here

13 as I go on as to what information was not

14 considered.

15 Number one primarily was the

16 initial set of comments that was included in

17 the Neudorff opinion. And that opinion was

18 submitted several times to the docket and that

19 was not considered. Okay.

20 Well, in deciding on the Crops

21 Committee's recommendation we would urge the

22 board to consider in addition the decisions by
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1 other regulatory authorities around the world

2 as to what is the active ingredient in

3 Neudorff's two slug baits. 

4 EPA as well as other organizations

5 such as the EU, IFOAM, Codex Alimentarius

6 Commission, all of them have decided that

7 there is only one active ingredient and it is

8 ferric phosphate. The European Commission

9 also specifically decided that EDTA was not

10 active and the products do not contain ferric

11 EDTA. So, that information was submitted to

12 the docket also on several occasions.

13 I might like to note that Neudorff

14 slug baits are mixtures. It's not a product

15 that's chemically reacted during production. 

16 There's four ingredients all of which are --

17 well, the inert's on List 4 and the active is

18 on the National List right now.

19 MR. FELDMAN: Thank you. Any

20 questions? Thank you very much.

21 MR. TALAREK: Thank you.

22 MR. FELDMAN: David Moore is up
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1 and Cam Wilson on deck.

2 MR. MOORE: Good afternoon and

3 thank you for this opportunity to address the

4 board. My name's David Moore. I'm a

5 California licensed agricultural pest control

6 advisor and qualified applicator, and I work

7 for Neudorff.

8 I'm here to encourage each member

9 of this board to affirm the Crops Subcommittee

10 recommendation and vote to reject the petition

11 to de-list ferric phosphate from the National

12 List.

13 Ferric phosphate is the sole

14 active ingredient in our product Sluggo, the

15 only effective molluscicide currently

16 available to organic growers. Assertions that

17 ferric phosphate is not an effective active

18 molluscicide and the implication that our

19 registration is somehow flawed by the presence

20 of an allowed inert fly in the face of

21 regulatory findings the world over and have no

22 basis in science.
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1 The finding that ferric phosphate

2 is an active molluscicide is shared by the

3 U.S. EPA, IFOAM, ECOCERT, the EU regulatory

4 body and other regulatory organizations the

5 world round. Neither the supplemental

6 technical report nor the subcommittee

7 recommendation makes any attempt to state a

8 definitive conclusion on this issue because

9 there is no definitive conclusion.

10 The voice of the organic grower

11 has been unanimous in support of ferric

12 phosphate and this voice includes growers that

13 are large and small all around the U.S.

14 growing a wide variety of crops. In some

15 cases these growers are producing a

16 preponderance of the entire U.S. organic

17 production of that crop.

18 These growers have spoken directly

19 to the negative impact that removing ferric

20 phosphate will have on production and

21 availability of certified organic citrus,

22 celery, leafy greens, strawberries and other
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1 soft fruits. These are all agronomically

2 challenging high-value crops.

3 I ask you today to please keep in

4 mind the three E's of sustainability. One of

5 these E's is economics and specialty crops

6 grown organically have been a key factor in

7 the economic sustainability of many small

8 farms. The loss of economically sustainable

9 certified production threatens the survival of

10 these farms and will result in fewer acres in

11 certified organic production.

12 Many of these growers will choose

13 not to attempt to compete in the conventional

14 market and these acres may then be lost

15 entirely to agriculture because of the far

16 higher land value when developed for other

17 uses. 

18 The removal of the listing for

19 ferric phosphate will place the U.S. organic

20 standards outside the international norm on

21 this material and can have only disruptive

22 effects and will place U.S. growers at a
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1 disadvantage. 

2 The so-called alternatives cited

3 in the various technical reports do not

4 reflect agricultural reality. There are no

5 field workers in strawberry fields or citrus

6 groves hand-picking snails and slugs at night

7 when the pest is active. A grower cannot

8 exclude a pest from their field if that pest

9 is already present and persistent in the soil

10 fostered by the important practices of cover

11 cropping, fallowing and conservation tillage. 

12 The introduction of vertebrate

13 predators such as poultry violates every basic

14 food safety best practice and the soil

15 fertility and crop nutrient standard 203(c)(1)

16 and (2). 

17 The report suggests chemical

18 killing solutions that may violate FIFRA if

19 they're not registered pesticides and more

20 importantly, many of the cited materials are

21 not allowed for this use in certified organic

22 agriculture. 
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1 Lastly, data reflecting large2 scale industrial dumping of EDTA in the past

3 is not germane to the agricultural product in

4 use at hand for your vote today. 

5 Again, I'd like to encourage every

6 member of this board to affirm the Crops

7 Subcommittee recommendation and reject this

8 petition. The review process developed by the

9 Inerts Working Group and adopted unanimously

10 by the board will address the many allowed

11 synthetic List 4 inert ingredients with due

12 process and proper scrutiny. Thank you very

13 much.

14 MR. FELDMAN: Perfect timing,

15 thank you.

16 MR. MOORE: I tried.

17 MR. FELDMAN: Any questions from

18 the board? Thank you very much.

19 MR. MOORE: Thank you.

20 MR. FELDMAN: Okay, Moore and then

21 we will pick up with the next speaker which is

22 -- I'm sorry, Cam Wilson. We'll pick up with
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1 Liane Jenkins after the break. So, thank you.

2 MR. WILSON: Good afternoon, board

3 members. My name is Cam Wilson. I work for

4 the company Neudorff and I'm here to also talk

5 about ferric phosphate. We support the Crops

6 Committee decision to reject the Steptoe

7 petition to de-list and to keep ferric

8 phosphate on the National List.

9 A very important point here is all

10 regulatory bodies worldwide agree on one

11 common fact, that ferric phosphate is the only

12 active ingredient in the Neudorff bait. Here

13 we know it as Sluggo. EDTA is not an active

14 ingredient nor has it ever been identified as

15 an active ingredient anywhere in the world.

16 A similar petition to the Steptoe

17 petition was filed in Europe by a competitor

18 who manufactures metaldehyde baits. Based on

19 this review of this similar document the

20 European authorities concluded the following. 

21 And I'd like to quote something from their

22 report.
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1 Ferric phosphate is regarded as

2 the active substance. Annex I listing is

3 therefore justified. The coal formulants EDTA

4 or EDDS have no molluscicidal impact. 

5 In 2008 the EPA reviewed the

6 Sluggo registration, also confirmed that the

7 active ingredient is solely ferric phosphate. 

8 It is not EDTA and it is not iron EDTA. 

9 Neudorff has registered ferric

10 phosphate baits in over 30 countries worldwide

11 and the authorities responsible in every one

12 of these countries have determined that ferric

13 phosphate is the only active. None of these

14 countries have determined that the chelate is

15 active. EDTA has no molluscicidal activity

16 and EDTA is a List 4 inert which is compliant

17 with the current organic regulations.

18 It's important to point out that

19 iron phosphate and EDTA do not react in the

20 bait and do not form other substances. 

21 Globally, organic certifiers recognize, such

22 as IFOAM, ECOCERT Canada, and OMRI allow
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1 ferric phosphate and the Neudorff bait as

2 certified for organic production.

3 Recently it was suggested that

4 ferric phosphate slug and snail baits had

5 adverse effects on earthworms. Neudorff

6 carried out its own extensive studies that

7 determined that the ferric phosphate baits did

8 not harm earthworms. They contracted a third

9 party, Lures Report 2009, that confirmed the

10 same thing, that the ferric phosphate baits do

11 not harm earthworms. This study was done at

12 rates at 4 times the label rate just to

13 challenge the study.

14 In conclusion, we support the

15 rationale of the Crops Committee that ferric

16 phosphate must be considered independently. 

17 And other ingredients and inert ingredients in

18 the ferric phosphate bait are currently

19 allowed under Section 205.601(m). The inert

20 ingredients will be addressed separately by

21 the Inerts Working Group. 

22 We kindly ask that the NOSB keep
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1 ferric phosphate on the National List and

2 remain harmonized with previous decisions and

3 organic certifications worldwide. U.S.

4 organic farmers need iron phosphate baits to

5 stay competitive with other countries. Thank

6 you and I'll leave myself for questions.

7 MR. FELDMAN: Thank you very much. 

8 Any questions from the board? Thank you very

9 much.

10 MR. WILSON: Thank you.

11 MR. FELDMAN: So we're going to

12 take a break, folks, 15 minutes. Regroup here

13 at 3:45 on the nose and we will pick up with

14 the five remaining public commenters in the

15 Crops Subcommittee category. And then the

16 board will try to vote on the issues that we

17 figure we can vote on. So we'll let you know.

18 (Whereupon, the foregoing matter

19 went off the record at 3:29 p.m. and went back

20 on the record at 3:44 p.m.)

21 MR. FELDMAN: Okay, the meeting is

22 called to order. Thank you all. So, Liane,
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1 go ahead. Thank you. 

2 MS. JENKINS: Hello and thank you

3 for this opportunity to present to the board. 

4 My name is Liane Jenkins, senior regulatory

5 and compliance specialist at Lonza. Lonza is

6 a technical manufacturer of metaldehyde which

7 is used in formulating a non-organic

8 molluscicide. Metaldehyde competes with

9 Neudorff's ferric phosphate slug and snail

10 killer. Lonza believes in fair competition

11 between these products based on performance. 

12 Neudorff markets its ferric

13 phosphate products as organic. However, it

14 misleads organic producers and consumers as

15 ferric phosphate should not be considered

16 organic for three basic reasons.

17 One, ferric phosphate is not an

18 effective molluscicide without adding non19 organic EDTA to the formulation. Two, NOSB

20 previously denied organic listing for EDTA and

21 this decision should apply to ferric phosphate

22 products. And three, EDTA does not qualify
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1 for organic status under the National Organics

2 Program. I'll briefly elaborate on each of

3 these points.

4 First, ferric phosphate by itself

5 is not an effective molluscicide. The

6 supplemental technical review and USDA's

7 Agriculture Research Service assessment

8 concluded that ferric phosphate by itself has

9 limited effect on snails and slugs. Ferric

10 phosphate must be combined with a chelating

11 agent to be used in controlling these pests.

12 EDTA is what makes the product

13 truly efficacious. EDTA acts as a synergist

14 and only the combination of ferric phosphate

15 and EDTA will there be a toxic effect on these

16 snails and slugs. 

17 Neudorff's own patent documents

18 the need for EDTA in their ferric phosphate

19 slug control formulations. The patent shows

20 that ferric phosphate by itself has little to

21 no effect on the pest until combined with

22 EDTA. NOSB should conclude the combination of
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1 ferric phosphate and EDTA is a complete active

2 system and this active system is not on the

3 National Organics List.

4 Secondly, NOSB previously assessed

5 sodium ferric hydroxyl EDTA and rejected the

6 petition due to EDTA's behavior in the

7 environment. This assessment stated that EDTA

8 use results in harmful movement of metals in

9 soil and river sediments. EDTA degrades

10 slowly in the environment and EDTA poses a

11 risk to human health.

12 The recent supplemental technical

13 review determined that EDTA used in ferric

14 phosphate molluscicides poses the same risk as

15 the EDTA in previously assessed sodium ferric

16 hydroxyl. Since NOP already assessed the risk

17 of EDTA and deemed it incompatible with

18 organic production then this existing decision

19 should be implemented for ferric phosphate

20 products containing EDTA.

21 Lastly, ferric phosphate as a

22 molluscicide contains the ingredient EDTA
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1 which has already been determined to be

2 incompatible with organic production. That

3 means that current ferric phosphate products

4 are not truly organic. It misleads organic

5 producers and consumers of organically grown

6 food when ferric phosphate EDTA products are

7 offered as organic.

8 The organic consumer understands

9 that organically produced foods are not

10 treated with synthetic pesticides, the

11 ingredients do not cause harm to the

12 environment or to themselves or their

13 families. This is not the case when ferric

14 phosphate is used as a molluscicide due to the

15 EDTA in the formulation.

16 Ferric phosphate uses EDTA which

17 is known to have an adverse effect on the

18 environment and humans. Based on this, ferric

19 phosphate products are not a true organic

20 material. NOSB should recommend it to de-list

21 from the National Organics List and USDA's

22 National Organic Program should promptly take
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1 the formal step to complete the de-listing.

2 Our written comments to NOSB

3 submitted last month stated the legal standard

4 for a material to be considered organic: 1) it

5 must not be harmful to human health or the

6 environment; 2) it must be necessary to

7 production because of the unavailability of a

8 wholly natural substitute; and 3) it must be

9 consistent with organic farming and handling.

10 As I've discussed, ferric

11 phosphate fails to meet the standard and hence

12 should not be considered organic. We urge the

13 board to vote to de-list ferric phosphate from

14 the National Organics List. Thank you very

15 much for your time and attention.

16 MR. FELDMAN: Thank you. Any

17 board questions? Thank you very much. Luis -

18 - can you pronounce your last name for me?

19 MR. MONEGE: You did it great.

20 MR. FELDMAN: Monege? 

21 MR. MONEGE: Yes.

22 MR. FELDMAN: Okay, perfect. 
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1 Okay, and Marco Castor is on deck.

2 MR. MONEGE: Good afternoon. My

3 name is Luis Monege. I work with organic

4 banana growers in Peru including Colombia. 

5 And I'm here today to speak on their behalf.

6 During the last 3 years the

7 organic banana industry in South America has

8 faced a new threat, the red rust, a small

9 insect that reproduces very fast and affects

10 the quality of the fruit, making it non11 exportable.

12 The insect damages the fruit when

13 the flowers are still closed. The control of

14 this pest is very difficult and most of the

15 available control alternative has proven to be

16 ineffective. 

17 In 2010 on Esperanza Farm in

18 Ecuador, a 15 years old organic banana farm

19 was attacked for the first time by the red

20 rust thrips. The researchers tried all known

21 and reported alternatives such as cultural

22 practices, spraying repellants and approved
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1 insecticides applications. Over 15 different

2 substances and treatments were tested. 

3 Cultural practices and repellants

4 showed to have low or no effect at all over

5 the pest. Only two substances presented

6 acceptable control, pyrethrins and

7 lonchocarpus roots extract also called

8 rotenone. Both substances are needed in an

9 integrated pest management program in order to

10 avoid resistance issues and to control

11 outbreaks that range from slight to severe. 

12 In case of a severe outbreak only rotenone has

13 proven effective. 

14 Red rust affected Nueva Esperanza

15 Farm so seriously during 2010 and 2011 that

16 exportable fruit volume was lower on one-sixth

17 of its production, from half a million boxes

18 per year to only 75,000 boxes. This

19 illustrates the severe production decreases

20 that can occur without the use of rotenone,

21 making organic banana production unsustainable

22 and leading to the closing of hundreds of
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1 farming operations.

2 Nueva Esperanza Farm is not an

3 isolated case. Thousands of small, medium and

4 large organic banana growers in Peru, Ecuador

5 and Colombia are facing similar situations. 

6 The problem is becoming bigger and

7 it has the potential to seriously affect the

8 supply of organic bananas from those countries

9 which represent the 95 percent of the U.S.

10 market supply. Signatures of organic banana

11 growers organization representing more than

12 2,000 organic growers on more than 5,000

13 hectares of organic certified land from Peru,

14 Ecuador and Colombia were submitted to the

15 NOSB stating their opposition to the Crops

16 Subcommittee proposal to add rotenone to

17 205.602 as prohibited natural substance.

18 This is a clear and loud message,

19 an SOS message from the organic growers in

20 Latin America asking this board to keep the

21 use of this natural plant extract as allowed

22 in organic as it currently is. The future of
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1 these organic growers and their families may

2 depend on your vote.

3 On the other hand, the organic

4 banana industry in South America is committed

5 on finding new and better alternatives for

6 integrated pest management but it requires

7 time to develop answers to the new challenges.

8 At the present time rotenone is

9 critical in organic banana production in South

10 America for red rust control. There are no

11 other alternatives available and the potential

12 damage of this pest is catastrophic. Please

13 on behalf of all those growers and those

14 families do not prohibit the use of rotenone

15 in organic agriculture. Thank you.

16 MR. FELDMAN: Thank you. Any

17 questions? Nick.

18 MR. MARAVELL: Yes. The damage

19 from the red rust thrip, does that lead to

20 damage -- is that cosmetic or does that lead

21 to spoilage of the fruit itself?

22 MR. MONEGE: It's cosmetic. It's
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1 just the skin. If you look at the picture

2 it's just the discoloration on the skin of the

3 fruit. But it's -- there is no internal

4 damage of the fruit. But it is rejected by

5 the market.

6 MR. MARAVELL: Oh, of course. So

7 in other words if it went into storage and was

8 shipped, et cetera, the fruit would still be

9 intact but the customer wouldn't buy it.

10 MR. MONEGE: Correct.

11 MR. MARAVELL: Thank you.

12 MR. FELDMAN: Thank you. Mac.

13 MR. STONE: Luis, is there a

14 relationship to weather patterns or other

15 factors that create the thrips thrive in

16 certain microclimates rather than others? And

17 kind of related to that, you heard this

18 morning that this group is pretty hard on the

19 apple growers, the poultry growers are being -

20 - the methionine issue and so you don't take

21 this personally, but the 3-year sort of window

22 that was discussed earlier to find an
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1 alternative, how scary is this 3-year

2 alternative to you?

3 MR. MONEGE: The most appropriate

4 answer I can give you right now is I don't

5 know. Three years from now sounds like a

6 whole bunch of time to develop alternatives

7 but the things in Latin America move a lot

8 slower than here. 

9 We have been investigating into

10 the literature about alternatives and we know

11 that the spinosad is something that has some

12 control in other crops in other regions of the

13 world over thrips similar to the thrips that

14 cause the red rust. But we don't know what is

15 going to happen in a banana plantation in the

16 tropical part of the world.

17 And the first thing that we have

18 to do is try to convince the manufacturer of

19 the molecule to go to Latin America to each

20 individual country to get the registration so

21 we can use it. So, is 2016 a good period of

22 time? I don't know. But I will say that if
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1 it is a period of time for you in the States

2 to get through the whole paperwork and all the

3 bureaucracy it could be even worse in Latin

4 America.

5 MR. FELDMAN: Any other questions? 

6 John.

7 MR. FOSTER: Typically how many

8 applications in a given year would you apply

9 to the crop?

10 MR. MONEGE: Well, it depends

11 because it's not all year round, right? I

12 mean we have our seasons. It depends on the

13 rainfall during the year. But it could be

14 every other week in a short period of time and

15 alternate with pyrethrins. But worst case

16 scenario will be every other week.

17 MR. FOSTER: Quick clarification

18 on that. Every other week for how long? For

19 3 months or 6 months? I know it's going to

20 vary from time to time, just typically.

21 MR. MONEGE: I would say worst

22 case scenario would be every other week during
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1 the whole year.

2 MR. FOSTER: Okay. Thanks.

3 MR. FELDMAN: Thank you, Luis. 

4 Luis, what about spinosad? Is it registered

5 for use in any of those countries or have you

6 looked at it all --

7 MR. MONEGE: It's not.

8 MR. FELDMAN: -- for this

9 particular species of thrip?

10 MR. MONEGE: No, it's not

11 registered. We are very close to the

12 manufacturer of the Entrust which is the most

13 popular formulation of a spinosad. But they

14 are reluctant to go through Peru, Ecuador and

15 Colombia and get the registration. The

16 process of get registered in those countries

17 is really difficult.

18 MR. FELDMAN: Thank you. 

19 Jennifer. One other question.

20 MS. TAYLOR: Thank you. What kind

21 of health issues have the workers reported in

22 regard to using this product?
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1 MR. MONEGE: Well, thank you,

2 Jennifer. This is a natural plant extract,

3 right? This substance is coming from pre4 Hispanic times. Since then, since the Native

5 Americans use it for different purposes. 

6 We have no registered events

7 related with human health. I mean, there is

8 no negative -- how you call it -- events I

9 will say regarding the use of rotenone. We

10 have no records in Latin America that

11 something like that happened.

12 MS. TAYLOR: But with the

13 knowledge now that, you know, it's a

14 possibility that it does happen in other

15 places --

16 MR. MONEGE: Well, yes.

17 MS. TAYLOR: -- how will you use

18 that knowledge with?

19 MR. MONEGE: Rudy Amador, my

20 colleague, is going to refer to that topic

21 specifically. I will prefer that he, as he is

22 the expert in that area he will answer that
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1 question. Gracias. 

2 MR. FELDMAN: Gracias. Marco and

3 Jack Manix on deck.

4 MR. AMADOR: Good afternoon. My

5 name is Rudy Amador. I'm replacing Marco who

6 unfortunately could not be here today.

7 I'm director of environmental

8 affairs for Dole in Latin America. We're

9 based in San Jose, Costa Rica. And we

10 appreciate the opportunity to come and speak

11 with you today. I will be speaking in favor

12 of maintaining rotenone on the NOP list for

13 some additional reasons as those given by

14 Luis. 

15 I don't have a lot of time to go

16 through risk management theory but if you take

17 a look at this picture we can all agree that

18 it is dangerous to jump off a building. You

19 can have a problem with the cement down below. 

20 If you don't manage the exposure side of the

21 risk management equation which is hopefully

22 you will put on a bungee cord which is UL-
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1 tested or an air mattress down below. But

2 basically the point is, and it applies not

3 only to rotenone but anything, any pesticide

4 or actually any farm input is that you need to

5 manage the exposure side of the equation.

6 Out of the EPA's RED from 2007 I

7 extracted basically the two dangers of

8 rotenone. The first one being acute toxicity

9 for human health, especially inhalation, and

10 the second one being infested environment

11 being very highly toxic to marine organisms. 

12 Again, we can manage that risk by decreasing

13 exposure. 

14 This is to answer a little bit of

15 the questions that Luis got, this is the

16 personal protective equipment that's actually

17 on the rotenone label down in Peru. Also the

18 same engineering controls accepted by the RED

19 that the EPA put out in 2007 in order to

20 reduce that risk to acceptable levels. That's

21 regarding the health risk mitigation.

22 And on the environmental side
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1 similarly there's good air culture practices

2 that are applied. In the case of rotenone

3 it's a liquid. It's applied only to the

4 pseudostem. This is the banana plant. There

5 is -- solids are not applied. 

6 Also, it's applied in areas that,

7 since it's organic bananas, in very low

8 rainfall areas and therefore very difficult

9 for the product to get to waterways and

10 produce an environmental effect. In addition

11 to that obviously we do not allow or permit

12 applications directly to water or drainage

13 canals or anything similar to that.

14 I wanted to present very quickly a

15 label. This is a label, the registered

16 product in Peru. Four things to point out

17 here. In addition to the local registration

18 that is required for any product and which

19 takes time to achieve for any alternative that

20 is found in that time will need to transpire

21 into the countries where we operate in. The

22 label specifically says, again, those risk
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1 mitigation measures, not contaminating water,

2 using the appropriate personal protective

3 equipment.

4 In addition, I wanted to point out

5 that there's other crops. We're here

6 representing organic bananas but there are

7 other crops that apparently are using this. 

8 This label mentions asparagus, cotton and

9 citrus.

10 The other very important point to

11 discuss here is the issue on international

12 regulatory scenario with rotenone. As early

13 as 2009 the Codex delegation was not

14 supporting the deletion of rotenone from the

15 Codex Practices on Organic Agriculture. And

16 on the most latest Codex list rotenone is

17 listed.

18 What they did there after 4 years

19 of discussion was that they were concerned

20 about effect on aquatic organisms. So they

21 added a restriction which is the substance

22 should not be used in such a way as to prevent
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1 -- or should be used in a way to prevent

2 flowing into waterways.

3 Similarly in the EU it is

4 registered and on the organic list. I'll end

5 up here, but very important for you to know

6 just 3 weeks ago here in the United States the

7 EPA decided not to revoke the tolerance

8 exemptions that it had proposed to do so

9 earlier in the year citing the need for

10 imported produce of this substance.

11 My time is over. I appreciate

12 your questions if you have any.

13 MR. FELDMAN: Thank you. 

14 Questions? John.

15 MR. FOSTER: So, the -- as

16 probably everyone knows I kind of have mixed

17 emotions about this particular material. How

18 effective or how useful would it be to imagine

19 a world where rotenone was on 602 with some

20 limiting annotations that would minimize its

21 per-year usage or crop usage? You're here

22 representing bananas so if it were only used
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1 on bananas, I don't know, twice a year and

2 only in rotation with other materials would

3 that be useful or not effective?

4 MR. AMADOR: I think we favor any

5 limitation that will minimize worker exposure

6 or exposure to the environment regarding good

7 agricultural practices. I do not think it's

8 a good agricultural practice to limit

9 applications to two times a year. That could

10 produce outbreaks that would have to be

11 controlled with other means that may not be as

12 effective as rotenone. 

13 And in some cases as the graph

14 that Luis mentioned we basically had to --

15 were on the verge of closing the farm until we

16 found this alternative. So we do not favor

17 restricting frequency. We do favor good

18 agricultural practices and establishing

19 mechanisms in which to protect workers and

20 water which are the two main issues.

21 MR. FELDMAN: Yes, Mac.

22 MR. STONE: Is rotenone used on
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1 any other tropical fruits?

2 MR. AMADOR: We are unfortunately

3 not very aware of that. We're basically

4 involved in the pineapple and banana business

5 out of Latin America. And I put that label

6 there on purpose because we found that one

7 that was listing those other four crops,

8 asparagus, cotton and there's one other there. 

9 But we were unaware of the use.

10 We do know, as Luis mentioned in

11 the organic banana industry this could be

12 basically a catastrophe if growers are not

13 allowed to use it as we have not been able to

14 find an alternative. And we continue to look

15 for alternatives, by the way. There's not a

16 better way to look for alternatives than if

17 you have your farm infested with this and you

18 make a decision in a few weeks' time. And we

19 were basically weeks away from closing our

20 farm. We were able to determine that rotenone

21 was effective and began applying it and

22 teaching our growers on how to do so
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1 appropriately.

2 MR. AUSTIN: In one of your slides

3 it showed the bunches, it showed the guy with

4 the PPE equipment and stuff and it looks like

5 your guys have been well trained. Go back one

6 now. That one.

7 Okay, so the method of application

8 is not to the entire plant specific but it's

9 to a very specific, it's to the fruit itself,

10 correct? Or am I misinterpreting what's

11 taking place there?

12 MR. AMADOR: Yes, it could be in

13 two different places. We call it the

14 pseudostem which is the trunk of the banana

15 plant. That is a place where this pest is

16 harbored. And also if you see infestation

17 around the fruit you need to do that too. So

18 in this case what the worker is doing is he's

19 lifting the plastic that's protecting the

20 fruit to make an application within the

21 developing banana stem.

22 Luis mentioned this but we've
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1 tried oils. One of the things that you see

2 with this is that the other products do not

3 get into contact effectively with the insect

4 and has left only rotenone as the alternative. 

5 But yes, the picture basically is showing

6 complete personal protective equipment which

7 is recommended by the product label and also

8 recommended as an engineering control by EPA.

9 MR. FELDMAN: Other questions? 

10 Thank you very much. I'm sorry, Calvin. Go

11 ahead.

12 MR. WALKER: Could you share with

13 us your last statement about conditional

14 approval?

15 MR. AMADOR: Yes, I was trying to

16 make a reference to what happened in the Codex

17 process. You know, they went through 4 years

18 of discussions and finally they decided well,

19 we're going to put in a restriction referred

20 to water. And you know, just the thought that

21 you could have an approval for renewable with

22 a conditional use wording to improve good
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1 agricultural practices, including worker

2 protection requirements and protecting

3 waterways.

4 MR. FELDMAN: Other questions? 

5 Thank you. Thank you very much.

6 MR. AMADOR: You're welcome, thank

7 you.

8 MR. FELDMAN: So Jack Manix and

9 Skip Paul is up on deck. Thank you.

10 MR. MANIX: Thank you. I'd like

11 to thank you for allowing me the opportunity

12 to get my 2 cents in on biodegradable mulch,

13 specifically BioTelo. My name is Jack Manix

14 and I'm a certified organic grower. I've

15 traveled from downtown East Dummerston,

16 Vermont to Providence on a beautiful sunny day

17 to try to help persuade you to approve this

18 product which I think is essential for organic

19 growers.

20 In 1993 14 towns in our county

21 tried to site a landfill and dump on our farm

22 and a KOA campground next to us and take some
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1 of the land by eminent domain. While I'm

2 talking to you I'm going to pass around this

3 highly offensive picture. I'm glad to see

4 there's no young adults on the board. It's a

5 dumpster full of black plastic.

6 And on our farm we eventually

7 fought that battle from 1993 to 1996 and won

8 the battle. And they gave up the siting of

9 the landfill. So the results of that is that

10 I hate trash. And on our farm which is a

11 family farm, been in my family since 1770 we

12 do everything possible to reduce, reuse and

13 recycle. 

14 Right now I produce about three

15 dumpsters' worth of black plastic. I have one

16 sitting on our property right now that's due

17 to be picked up tomorrow morning. It's

18 embarrassing and I think as an organic grower

19 where we try to do what's right for the Earth

20 it makes it difficult to have that as part of

21 our operation. 

22 But we need to use mulch plastics. 
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1 We've used black plastic because, well, the

2 global climate extremes have been a large

3 reason. This past summer the extreme heat has

4 kept, you know, we need that to retain soil

5 moisture. When it's raining we need it to

6 drain the moisture off the crops so that the

7 roots don't get too soggy. So we've tried

8 using hay and straw mulches and we do use a

9 lot of those also but they're costly, they're

10 difficult to apply mechanically and in the

11 long run small growers and large growers alike

12 find the costs involved with mulches worth the

13 effort in producing a product that you can

14 sell competitively, organically to families

15 and neighbors.

16 I'm a member of NOFA Vermont board

17 of directors, the Vermont Vegetable and Berry

18 Growers Association, Vermont Association of

19 Professional Horticulturalists, the Vermont

20 State Farm Bureau. And I come in contact with

21 a lot of young growers. And one of the

22 previous speakers mentioned that we're losing
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1 organic growers and yes, we are losing some

2 organic growers. I feel a large part of that

3 is because we don't market organics nearly

4 well enough. The only time I see organics is

5 in magazines that are directed toward organic

6 people. I don't see it on Fox News and I

7 don't see it in a lot of periodicals that we

8 should be approaching for our market.

9 But one of the reasons we're also

10 losing organic growers is because they don't

11 understand the logic of not being able to use

12 these BioTelo mulches. We keep trying to

13 reinvent the wheel. They're being used in

14 Europe and Canada for a long time. I know a

15 lot of growers in New York State and

16 Massachusetts that don't become certified

17 because they need to use these organic

18 mulches.

19 On our farm it's really essential

20 for reducing the label and the use of fossil

21 fuels. So I urge you to consider the approval

22 of these organic mulches for organic farmers. 
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1 Thank you.

2 MR. FELDMAN: Thank you. Any

3 questions? Thanks for coming down on a

4 beautiful day.

5 MR. MANIX: Thank you.

6 MR. FELDMAN: Skip Paul, please.

7 MR. PAUL: I wanted to thank the

8 board for allowing a few farmers to get away

9 from picking up plastic mulch and come down

10 here and talk to you about what we really want

11 to do is harrow in BioTelo mulch.

12 My name is Skip Paul and I'm from

13 -- actually a Rhode Island farmer. I'm from

14 Little Compton, Rhode Island which is just as

15 the crow flies about 50 miles down that way. 

16 Wishing Stone Farm has been growing

17 organically since 1982. We were one of the

18 first organic farms certified in Rhode Island. 

19 Right now our acreage is over 38 acres

20 representing seven small diversified farms

21 near our home farm.

22 To manage these farms
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1 successfully, and some of them are over 3

2 miles away, we have come to rely on plastic

3 mulch to control weeds, to retain moisture and

4 manage water efficiency in our crops, and

5 three, to give and add heat to -- as in soil6 warming for early crops and even late-season

7 crops. Quite often we'll put broccoli late,

8 or hail Mary broccoli we call it on plastic

9 mulch just because it actually gives us the

10 heat to drive it into December. 

11 At this stage in our evolution we

12 are covering I'm ashamed to say over 40

13 percent of our crop lands with plastic mulch

14 of some form or another. My family's sole

15 income comes from farming so our marketing is

16 30 percent farmers markets, 20 percent

17 wholesale and 50 percent CSA which represents

18 over 385 families some of which have been with

19 us for over 20 years.

20 We are year-round growers which

21 means we grow and cultivate crops over 365

22 days a year. We are constantly in
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1 communication with our patrons and develop

2 deep relationships with not only our CSA

3 members which we have contact with longer but

4 with over 3,000 farmers market patrons which

5 visit us weekly at our farmers market in

6 Providence.

7 We are continually in

8 communication with our patrons about issues

9 facing us as farmers, how to do a better job,

10 but also issues facing us as fellow human

11 beings on this planet. Since the arrival of

12 BioTelo on the ag stage more and more

13 conversations have spontaneously developed

14 around what it is and how does it work. 

15 An earlier farmer that came up,

16 Paul and Sandy Arnold, have been valuable

17 pioneers in working and evaluating the

18 BioTelo's effectiveness and biological safety

19 of this product, not to mention reams of

20 papers and articles that have been penned in

21 Europe and Canada and elsewhere extolling its

22 biological virtues.
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1 These conversations are going on

2 with our CSA members and farmers market

3 customers too. As they are getting better and

4 better informed about the safety and

5 effectiveness of BioTelo they are asking the

6 same question as we farmers are. What is the

7 biological rationale of putting tons of oil8 based completely synthetic plastic into our

9 nation's landfills when we could be using

10 BioTelo?

11 I feel BioTelo will save us energy

12 because it's less tractors work going over,

13 taking up plastic and doing other things. It

14 will keep the fields adjacent to us cleaner

15 and more sanitary. It will help us get cover

16 crops more quickly and more efficiently,

17 capturing nutrients left over from other crops

18 and helping keep disease pressure down by more

19 quickly being able to destroy diseased crops. 

20 This was particularly important this year with

21 late blight on tomatoes and other things.

22 Pulling black plastic up, you have
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1 to remove the plants by hand first. You can't

2 -- no machine will take that up and so there's

3 a lot more labor in pulling up black plastic

4 mulch. 

5 This issue has come to the

6 forefront at our farm and has now gained such

7 an importance that our members who are

8 informed about this subject are urging us to

9 drop certification on CSA plastic mulch

10 acreage so we can use BioTelo and be more

11 biologically responsible.

12 MR. FELDMAN: Thank you very much. 

13 Any questions from the board? Well -- oh, I'm

14 sorry. Go ahead.

15 MR. FOSTER: How have you found

16 its -- you know what, never mind. It's not

17 going to be a relevant question for you.

18 MR. FELDMAN: Okay. Thank you so

19 much for participating in this process.

20 MR. PAUL: Thank you.

21 MR. FELDMAN: And we thank

22 everybody that participated in the comment
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1 process today, public comment process. 

2 We will now try to segue way in

3 the next half hour or so to some of the votes. 

4 The Crops Committee came together briefly to

5 get a sense of whether people felt comfortable

6 voting on some of these materials. And we

7 decided, or I didn't hear any objections to

8 moving ahead with at least some of these votes

9 and see how far we get.

10 It may be after we heard the

11 rotenone discussion we should discuss that

12 more? It's up to you all. But we could start

13 at the top of the list, ferric phosphate, and

14 work our way down if that's okay. Any

15 objections to doing that? Okay. Okay, thank

16 you. 

17 CHAIRPERSON FLAMM: So you're

18 prepared to move forward on ferric phosphate. 

19 Is there a motion? And I need something in

20 writing so I can make sure that the motion is

21 in order. Okay, thank you. I've got it.

22 You wish to proceed with making a
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1 motion?

2 MS. BECK: All right, so I'd like

3 to make the motion to remove ferric phosphate

4 from Section 205.601(h).

5 CHAIRPERSON FLAMM: Is there a

6 second to the motion?

7 MR. BONDERA: I'll second that.

8 CHAIRPERSON FLAMM: The motion has

9 been seconded to remove ferric phosphate from

10 Section 205.601(h). Discussion? Zea?

11 MS. SONNABEND: Thank you, Barry. 

12 I just want to make a very brief

13 clarification. I hope everyone realizes this,

14 but a vote yes will remove it from the list

15 and a vote no will leave it on the list. It's

16 a little backwards for some of our other

17 votes.

18 CHAIRPERSON FLAMM: Any other

19 discussion, comments? If not we'll proceed

20 with a vote starting with Jay.

21 MR. FELDMAN: Yes.

22 MS. SONNABEND: No.
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1 MR. STONE: No, sir.

2 CHAIRPERSON FLAMM: No.

3 MS. FAVRE: No.

4 MR. AUSTIN: No.

5 MS. BECK: No.

6 MS. RICHARDSON: No.

7 MR. FOSTER: No.

8 MR. DICKSON: No.

9 MS. FULWIDER: No. 

10 MR. WALKER: No.

11 MR. BONDERA: Yes.

12 MS. TAYLOR: Yes.

13 MR. MARAVELL: No.

14 CHAIRPERSON FLAMM: The vote is 3

15 yeses, 12 nos. The motion fails to pass. 

16 Does the Crops Committee have

17 another proposal that they wish to move on?

18 MR. FELDMAN: Proposal to the

19 petition on oxidized lignite which you'll

20 state I guess, is that right?

21 MS. SONNABEND: So the oxidized

22 lignite recommendation is the same as in the
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1 posted document, no changes. And once again -

2 - well --

3 CHAIRPERSON FLAMM: Zea, please

4 just state the motion and we'll get discussion

5 afterward.

6 MS. SONNABEND: Yes, I'm waiting

7 for Michelle to put it up. Okay. To add --

8 okay. 

9 This has two motions, a

10 classification motion and a listing motion. 

11 The classification motion is that humic acids

12 that are hydrogen peroxide-extracted are

13 synthetic. 

14 MR. FOSTER: I'll second that.

15 CHAIRPERSON FLAMM: Okay, the

16 motion has been made and seconded to classify

17 hydrogen peroxide-extracted as synthetic. We

18 need to take a vote on this. I'll ask if

19 there is any discussion. Any discussion on

20 classification of this material? 

21 We never did the beginning of your

22 committee. You were supposed to do the -- so
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1 we've got a policeman in the court. So we

2 apologize for not doing that earlier but I

3 think for simplicity I'll just do it now and

4 ask if anybody has anything that they want to

5 reveal or discuss or ask an opinion on in

6 terms of their ability to vote on this and any

7 other materials we'll be voting on. And I

8 want to make this retrospective if there was

9 anything regarding ferric phosphate. I

10 apologize. Jay.

11 MR. FELDMAN: I just want to share

12 with the board what I shared with the program. 

13 I'll just read what I sent the program. I do

14 not believe that I have any conflicts of

15 interest regarding upcoming votes of the NOSB. 

16 However, the organization that employs me may

17 have members who use or may use petitioned

18 materials under consideration by the NOSB. 

19 Similarly, the organization I work for may

20 receive contributions to support the

21 organizations national forum from companies

22 that use or may use materials before the NOSB. 
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1 CHAIRPERSON FLAMM: Okay. Jay has

2 disclosed that interest. Is there any comment

3 by anyone on that? Including if the program

4 feels that they wish to speak up. If not we

5 can move on to Zea. 

6 MS. SONNABEND: I wish to make a

7 voluntary disclosure of my interest also. I

8 do not believe I have any conflicts with any

9 of the items on the agenda and have asked the

10 Department for that ruling and they have said

11 I do not need to recuse myself. 

12 However, I am a farmer who

13 certainly uses things with inert ingredients

14 in it and work for an organization that is a

15 certifier that may certify anything that gets

16 approved for the National List as well as

17 being affiliated with three other non-profit

18 entities who may or may not submit comments on

19 anything at any particular time.

20 I get no financial gain directly

21 from any of those activities except hopefully

22 farming sometime. But not from direct use of
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1 the products on the list.

2 CHAIRPERSON FLAMM: Board members,

3 you've heard the disclosure by Zea. Any

4 thoughts? Any comments by anybody including

5 the program? And Zea has already indicated

6 that she's run that by the program. We'll

7 move on. John?

8 MR. FOSTER: So I too, a number of

9 the contract growers -- this will be true for

10 handlers too -- may use some of these

11 materials. I don't -- may want to use them. 

12 I'm sure some will. But I don't have any

13 direct financial gain from any of the

14 companies involved.

15 I'm sure they're somewhere in our

16 supply -- in Earthbound's supply chain but --

17 or going to be, but that's the limit of it. 

18 And that's what I declared in writing to the

19 program, I don't know, whenever it was, a

20 couple of weeks ago.

21 CHAIRPERSON FLAMM: Thank you for

22 that, John. Any comments on John's disclosure
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1 of his activities which was previously

2 disclosed? I don't believe any comment from

3 the program. Any other? If not we can -- I

4 think we can proceed and thank you, Tracy, for

5 being our watchdog. Thank you.

6 I believe -- I'd ask whether or

7 not there was any discussion on the

8 classification of this material. Hearing none

9 I believe we can begin with the voting I think

10 starting with Zea.

11 MS. SONNABEND: Yes, oxidized

12 lignite is synthetic.

13 MR. STONE: Yes, sir.

14 MS. FULWIDER: Yes.

15 MR. AUSTIN: Yes.

16 MS. FAVRE: Yes.

17 MS. BECK: Yes.

18 MR. DICKSON: Yes.

19 MR. FOSTER: Yes.

20 MS. RICHARDSON: Yes.

21 MR. WALKER: Yes.

22 MR. BONDERA: Yes.
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1 MS. TAYLOR: Yes.

2 MR. MARAVELL: Yes.

3 MR. FELDMAN: Yes. 

4 CHAIRPERSON FLAMM: And the chair

5 votes yes. Now we can entertain a motion on

6 the listing of the material. 

7 MS. SONNABEND: The motion is to

8 change the listing in 7 C.F.R. 205.601(j)(3)

9 to humic acids, naturally occurring deposits,

10 water, alkali and hydrogen peroxide extracts

11 only to expire in 2017.

12 CHAIRPERSON FLAMM: All right. Do

13 we have a second to that motion?

14 MR. FELDMAN: Second.

15 CHAIRPERSON FLAMM: We have a

16 second to the motion to change the listing in

17 7 C.F.R. 205.601(3) to humic acids, naturally

18 occurring deposits, water, alkali and hydrogen

19 peroxide extracts only to expire in 2017. 

20 Discussion on the motion?

21 MS. BAILEY: Excuse me -- thanks. 

22 So just a clarification. So the annotation
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1 that you have there says to expire in 2017. 

2 We would advocate that you put the actual date

3 for sunset in 2017 there so that it says

4 October, I believe it's October 21, 2017.

5 MS. SONNABEND: Oh, I accept that

6 amendment as the motion-maker. Does the

7 second accept it?

8 MR. FELDMAN: Yes, he does.

9 CHAIRPERSON FLAMM: We have a

10 proposed amendment to the motion. Could you -

11 - is it acceptable to the person making the

12 motion and the second?

13 MS. SONNABEND: Yes.

14 MR. FELDMAN: Yes.

15 CHAIRPERSON FLAMM: Okay. Could

16 you please -- as the originator of the

17 original motion would you state the -- restate

18 the amended motion? Oh, okay.

19 MS. BROWN-ROSEN: Sorry. Yes, the

20 previous sunset date in the proposed rule was

21 October 21, 2017 but when we issued the final

22 rule for sunset 2012 the sunset date for the
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1 current listing for humic acids was moved up

2 to June 27, 2017. So June 27 would be the

3 date that we would recommend to include. 

4 Sorry for the confusion.

5 MS. SONNABEND: June what?

6 MS. BROWN-ROSEN: Twenty-seven.

7 CHAIRPERSON FLAMM: Okay. Just so

8 we get the right date. 

9 MS. SONNABEND: So, the full

10 motion is to change the listing in 7 C.F.R.

11 205.601(j)(3) to humic acids, naturally

12 occurring deposits, water, alkali and hydrogen

13 peroxide extracts only to expire on June 27,

14 2017.

15 CHAIRPERSON FLAMM: And that

16 change of date is accepted by the person

17 seconding the motion?

18 MR. FELDMAN: Yes.

19 CHAIRPERSON FLAMM: Okay. So the

20 motion was amended to change the date to June

21 22 -- 27, 2017. Discussion on the motion? 

22 Any discussion on the motion? If not we can
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1 proceed with the vote beginning with Mac.

2 MR. STONE: Yes, sir.

3 MS. FULWIDER: Yes.

4 MR. AUSTIN: Yes.

5 MS. FAVRE: Yes.

6 MS. BECK: Yes.

7 MR. FOSTER: Yes.

8 MR. DICKSON: Yes.

9 MS. RICHARDSON: Yes.

10 MR. WALKER: No.

11 MR. BONDERA: No.

12 MS. TAYLOR: No.

13 MR. MARAVELL: No.

14 MR. FELDMAN: No.

15 MS. SONNABEND: No.

16 CHAIRPERSON FLAMM: And the chair

17 votes no. So we've got to do a tally here. 

18 The vote was 8 yes, 7 no. The motion failed. 

19 Jay, do you have another?

20 MR. FELDMAN: The next proposal is

21 the petition on PGML. 

22 MR. BONDERA: So I would like to
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1 suggest that we entertain two motions on PGML. 

2 And the first one is classification and I

3 would like to myself make that motion that

4 PGML is synthetic. 

5 MR. FELDMAN: Second.

6 CHAIRPERSON FLAMM: I don't have

7 the material here. The motion has been made

8 and seconded to classify PGML as a synthetic. 

9 Is there discussion on the motion? Hearing no

10 need for further discussion we can begin the

11 voting on the classification of PGML beginning

12 with Wendy.

13 MS. FULWIDER: Yes.

14 MR. AUSTIN: Yes.

15 MS. FAVRE: Yes.

16 MS. BECK: Yes.

17 MR. FOSTER: Yes.

18 MR. DICKSON: Yes.

19 MS. RICHARDSON: Yes.

20 MR. WALKER: Yes.

21 MR. BONDERA: Yes.

22 MS. TAYLOR: Yes.
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1 MR. MARAVELL: Yes.

2 MR. FELDMAN: Yes.

3 MS. SONNABEND: Yes.

4 MR. STONE: Yes, sir.

5 CHAIRPERSON FLAMM: And the chair

6 votes yes. I believe the count is 15 yes,

7 zero no. The motion passes. Do we have a

8 motion on the listing of this material? The

9 PGML. 

10 MR. BONDERA: Yes, thank you. I

11 would like to make that motion to add PGML to

12 the National List 205.601(e) as an acaricide.

13 CHAIRPERSON FLAMM: Do we have a

14 second to the motion?

15 MR. FOSTER: I'll second.

16 CHAIRPERSON FLAMM: Who seconded? 

17 Okay, John. It's been moved and seconded to

18 add PGML to the National List 205.601(e) as an

19 acaricide. Discussion? Any discussion on the

20 motion? Harold.

21 MR. AUSTIN: Yes, I think I would

22 like to just mention that, you know, this is
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1 a material as we look to vote on it. A lot of

2 the materials that we look at deal with

3 essentiality and we have to discern whether or

4 not the other materials that are listed as

5 alternative materials are in fact truly what

6 they're claimed to be. Are they actually

7 alternative, are they effective alternative

8 materials. Do they have the proper efficacy? 

9 Do they have the proper control? Are they as

10 environmentally friendly as what we think they

11 are?

12 I look at this material, I look at

13 the alternatives that have been listed and I

14 have some of the same concerns with those

15 materials as some of the board members have

16 with this particular material, whether to list

17 it or not list it as far as their impact on

18 the environment, their impact on the

19 predacious insects. 

20 I'm going to vote in favor of this

21 but because I think the organic growers need

22 a material that is effective at a time when
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1 it's needed. A lot of the products that are

2 out there right now are not immediately

3 effective if a grower finds himself into a

4 mite situation, a flare-up, there's not viable

5 materials out there, especially in tree fruit

6 and stuff that will really bail them out of a

7 hot spot if they really, truly get into a

8 difficult time. So being able to take and put

9 a material, another tool out there that our

10 organic growers could utilize, I think there's

11 value to that.

12 CHAIRPERSON FLAMM: Further

13 comments, discussion on this material? PGML. 

14 John?

15 MR. FOSTER: I would add to that -

16 - I agree with Harold -- add to that that I

17 continue to have faith in the expectation that

18 205.206 and that kind of mandatory IPM system

19 would necessitate a pretty good look at an

20 appropriate record that other practices, other

21 alternatives have been ineffective. And I

22 want to keep driving that point home because
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1 I don't think it hits the discussion table

2 often enough. So I continue to have faith in

3 that process and the rest of the regulation

4 and how it's implemented. And I think in that

5 context this is an appropriate material. 

6 CHAIRPERSON FLAMM: Further

7 discussion? Mac?

8 MR. STONE: Just as a tally-taker

9 helping Wendy to make sure, remind everybody

10 that there's no rush to convey your vote so

11 that we can accurately tally. So when it

12 comes your turn there's no rush to vote.

13 CHAIRPERSON FLAMM: Any further

14 discussion on this proposed -- this petition

15 material to be listed? All right, I believe

16 we can then proceed with a vote starting with

17 Harold.

18 MR. AUSTIN: Yes.

19 MS. FAVRE: No.

20 MS. BECK: Yes.

21 MR. FOSTER: Yes.

22 MR. DICKSON: Yes.
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1 MS. RICHARDSON: No.

2 MR. WALKER: No.

3 MR. BONDERA: No.

4 MS. TAYLOR: No.

5 MR. MARAVELL: No.

6 MR. FELDMAN: No.

7 MS. SONNABEND: No.

8 MR. STONE: No, sir.

9 CHAIRPERSON FLAMM: And the chair

10 votes no. Oh, I did it. You're next,

11 Jennifer. Okay, I retract my vote.

12 MS. FULWIDER: I vote yes.

13 CHAIRPERSON FLAMM: The chair

14 votes no. The vote is 5 yes, 10 nos. The

15 motion fails. Does the Crops Committee have

16 another proposal for consideration?

17 MR. FELDMAN: The review of inert

18 ingredients. 

19 MS. SONNABEND: On this one it's a

20 little different than a petitioned item or

21 anything because what -- the reason that we

22 need a vote is to move forward with the whole
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1 procedure. And so when we're voting for this

2 we're not voting for exactly what's in each

3 group of inerts or exactly what regulatory

4 language is going to be or be locked into the

5 details, but just to set in motion the things

6 we need to set in motion in order for the

7 procedure to move forward.

8 And so therefore the motion is the

9 whole procedure but in terms of making it

10 feasible for the voting sheet we're going to

11 just say the motion to adopt the proposed

12 Policy and Procedure Proposal on other inert

13 ingredients in pesticide formulations on the

14 National List. 

15 MR. FELDMAN: I'll second.

16 CHAIRPERSON FLAMM: There's -- the

17 motion has been made and seconded to adopt the

18 proposed Policy and Procedures Proposal on

19 other inert ingredients in pesticide

20 formulation on the National List which is I

21 think we should reference the document or the

22 date some way.
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1 MS. SONNABEND: Well, that's the

2 title of the document that I read into the

3 motion.

4 CHAIRPERSON FLAMM: Okay, this has

5 been read into the record and it was posted on

6 -- properly posted. Is there any question by

7 the board about understanding what the motion

8 is and what we're voting on? If there's any

9 doubt please speak up, otherwise I'll proceed

10 with the discussion. 

11 Any discussion on this document? 

12 Procedural document. Any discussion? Hearing

13 none I believe we should proceed with a vote. 

14 I think, Tracy, you are first off.

15 MS. FAVRE: Yes.

16 MS. BECK: Yes.

17 MR. FOSTER: Yes.

18 MR. DICKSON: Yes.

19 MS. RICHARDSON: Yes.

20 MR. WALKER: Yes.

21 MR. BONDERA: Yes.

22 MS. TAYLOR: Yes.
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1 MR. MARAVELL: Yes.

2 MR. FELDMAN: Yea.

3 MS. SONNABEND: Yes.

4 MR. STONE: Yes, sir.

5 CHAIRPERSON FLAMM: Wendy?

6 MS. FULWIDER: Yes.

7 MR. AUSTIN: Yes.

8 CHAIRPERSON FLAMM: And the chair

9 votes yes. Fifteen yeses, zero nos, the

10 motion passes. Does the Crops Committee have

11 any other proposals they wish to be considered

12 at this time?

13 MR. FELDMAN: I'd like to skip to

14 sulfuric acid and do that one. So John, I

15 turn that over to you.

16 MR. FOSTER: We have two motions

17 regarding sulfuric acid. The first one will

18 be a classification motion. The motion would

19 be to consider sulfuric acid as synthetic. I

20 would move that.

21 MR. BONDERA: I'll second that.

22 CHAIRPERSON FLAMM: It's been
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1 moved and seconded to classify -- read what

2 you said -- sulfuric acid as synthetic. 

3 Discussion on the motion? Hearing none we can

4 proceed with a vote beginning with Carmela.

5 MS. BECK: Yes.

6 MR. FOSTER: Yes.

7 MR. DICKSON: Yes.

8 MS. RICHARDSON: Yes.

9 MR. WALKER: Yes.

10 MR. BONDERA: Yes.

11 MS. TAYLOR: Yes.

12 MR. MARAVELL: Yes.

13 MR. FELDMAN: Yes.

14 MS. SONNABEND: Yes.

15 MR. STONE: Yes, sir.

16 MS. FULWIDER: Yes.

17 MR. AUSTIN: Yes.

18 MS. FAVRE: Yes.

19 CHAIRPERSON FLAMM: And the chair

20 votes yes. I believe we have 15 yeses and

21 zero nos. We can proceed with a motion on the

22 listing of this material. 
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1 MR. FOSTER: The second of two

2 motions, that would be to list on 205.601(j)

3 sulfuric acid for stabilization of digested

4 poultry manure to a pH under 4.5 but not below

5 3.5. I would so move.

6 CHAIRPERSON FLAMM: Do we have a

7 second to that motion?

8 MR. AUSTIN: Second it.

9 CHAIRPERSON FLAMM: We have a

10 motion which has been seconded to list on

11 205.601 sulfuric acid for stabilization of

12 digested poultry manure to a pH under 4.5 but

13 not below 3.5. Discussion on the motion? 

14 Hearing no desire for discussion we can

15 proceed with a vote and I believe, John,

16 you're the one to start it off.

17 MR. FOSTER: Yes.

18 MR. DICKSON: Yes.

19 MS. RICHARDSON: No.

20 MR. WALKER: No.

21 MR. BONDERA: No.

22 MS. TAYLOR: No.
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1 MR. MARAVELL: No.

2 MR. FELDMAN: No.

3 MS. SONNABEND: No.

4 MR. STONE: No, sir.

5 MS. FULWIDER: No.

6 MR. AUSTIN: Yes.

7 MS. FAVRE: No.

8 MS. BECK: No.

9 CHAIRPERSON FLAMM: And the chair

10 votes no. Three yeses, twelve nos. The

11 motion failed. 

12 MR. FELDMAN: Mr. Chair, unless

13 there are any objections from the subcommittee

14 I'd like to propose postponing the additional

15 two material petitions until -- or motions and

16 petitions until Thursday.

17 CHAIRPERSON FLAMM: No objection? 

18 The remaining two proposals will be dealt with

19 on Thursday. I believe that concludes the

20 Crops Subcommittee work and we can move

21 directly to Materials Committee. 

22 Jennifer, if you would like to
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1 take over. The gavel is passed to you for

2 now. Symbolically, that's okay. Or you could

3 have it for real.

4 MS. TAYLOR: Audience, please sit

5 down. Please sit down. We're ready now. 

6 Thank you. Thank you for your patience.

7 I thought it would be good to

8 start with some of the public comments, the

9 written comments that we have received.

10 MS. ARSENAULT: Could you move

11 your mike closer?

12 MS. TAYLOR: I thought it would be

13 good to start with some of the public

14 comments, our written comments that we

15 received in the general docket that are often

16 foundational to the purposes of many of us

17 here as well as the proposal that we will

18 introduce.

19 I support having in place the

20 strongest possible standards for organic foods

21 products to protect consumers, to help protect

22 the resources of our planet and to keep us all
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1 safe. Having choices is as important to

2 consumers as keeping our food supply safe and

3 it is information, that is transparency, that

4 helps -- can we move to the first slide

5 please, Michelle? Thank you.

6 I support having in place the

7 strongest possible standards for organic

8 foods, products to protect consumers, to help

9 protect the resources of our planet, and to

10 keep us all safe. Having choices is as

11 important to consumers as keeping our food

12 supply safe and it is information, that is

13 transparency, that helps assure both.

14 Please consider chemical additives

15 and processes that harm people, animals and

16 the environment as the enemy and preserve the

17 organic methods of farming, production and

18 living as safeguards of our society by

19 preventing these substances and methods from

20 infiltrating our atmosphere, water, soil and

21 food.

22 Another written comment. Please
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1 keep the purity of the organic label and do

2 not allow the proposed or any other synthetic

3 substances under the organic label. Please

4 keep synthetics and chemicals out of organic

5 food and products for the good of all.

6 Another written comment from the

7 general docket. Paying a premium for an

8 honest product is okay with me, but if the

9 organic seal has been compromised in my eyes

10 I see no point in preferably selecting those

11 products.

12 Another comment. Please keep

13 organics safe.

14 The members of the National

15 Organic Standards Board Materials Subcommittee

16 include Jay Feldman who is also chair of the

17 Crops Committee, Calvin Walker who is also co18 chair of the Policy Development Subcommittee,

19 Wendy Fulwider, co-chair -- I'm sorry, chair

20 of the Livestock Subcommittee, John Foster who

21 chairs the Handling Committee -- I'm saying

22 committee and I mean subcommittee, okay? Zea
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1 Sonnabend who is co-chair of this committee,

2 the Materials Committee, as well as the chair

3 of the GMO Ad Hoc Subcommittee and myself.

4 The document that you have before

5 you represents the board's research priorities

6 for the year 2013. And Zea and Calvin as

7 leaders of -- key people and leaders in the

8 development of the document will discuss the

9 comments that we received and also the impact,

10 the potential impact that we see that this

11 document will have on the organic research

12 agenda.

13 MS. SONNABEND: Should we go ahead

14 and do it without slides? Because I believe

15 Calvin and I each have a copy of it and we

16 could just read through it. It's only six

17 slides. It could be short.

18 Okay, our slides are to summarize

19 the public comment that we received on the

20 research priorities. I want to make clear

21 that in our research priorities framework we

22 stated that the priorities would be collected
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1 over the past year and presented each fall at

2 each fall NOSB meeting. 

3 So you will not see anything in

4 our posted document of research questions that

5 arise during this meeting such as

6 biodegradable mulch. Those will be in our

7 next cycle of research priorities. But what

8 is on this research priorities collection is

9 the ones from the last two NOSB meetings

10 roughly, priorities that have been collected

11 over that time.

12 The criteria for research topics

13 are -- there we go. So the second slide. 

14 Well, it's on there, it's not on there. Okay,

15 the criteria for deciding what research topics

16 to include, and I've shortened these. 

17 Everyone can read them in our posted document,

18 but topics that are persistent and chronic,

19 challenging, controversial, nebulous, lacking

20 in primary research and relevant to assessing

21 the need for alternative cultural, biological

22 and mechanical controls to materials on the
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1 National List.

2 Okay, Calvin, do you want to talk

3 about the public comment? You want me to keep

4 going? Are you sure? All right. 

5 This is the public comments that

6 we received. We received 11 commenters and

7 this is in the regulations.gov docket. All of

8 them supported the research document. None of

9 them were opposed. Some of them had concerns

10 and suggestions. Then in addition after the

11 docket comment period closed we received two

12 more directly which we will talk about at the

13 end. 

14 Okay, so these are the main points

15 that were brought up in the comments. 

16 Research needs for organic farmers and

17 processors continue to be significant. 

18 Feedback to researchers, research institutions

19 and particularly the USDA, NIFA and the ARS on

20 needs of organic sector is incredibly

21 valuable. 

22 Two, methionine should be listed
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1 as a priority research topic. However, we do

2 not support the inclusion of animal byproducts

3 as an acceptable alternative. We request this

4 focus area be removed.

5 Three, methionine research should

6 focus on the viability of potential

7 alternatives and explore plant materials,

8 products of microbial fermentation, marine

9 species, insects, worms and other

10 invertebrates.

11 Four, organic farmers are

12 innovators and solutions developed on farms do

13 not always fit in the typical research

14 framework. And research on whole farm

15 management methods progresses from farms to

16 research institutions and back to farms these

17 systems questions need to be integrated into

18 research proposals. 

19 Five, the NOSB needs to carefully

20 consider evidence available in the independent

21 scientific literature. 

22 Six, proposed areas of research
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1 must be challenging and based on controversial

2 NOSB decisions is okay. However, research

3 needs that is persistent, lacking in primary

4 research and difficult to identify needs to be

5 a priority. For example, improved organic

6 weed control methods. We encourage concerned

7 citizens to include their own comments on

8 areas where they think organic production

9 needs further research.

10 Seven, research projects that

11 focus on the integration of farm systems are

12 extremely important because much research on

13 farm systems has tended to focus on isolated

14 aspects of farming practice. This methodology

15 limits the scope of the research question so

16 the results can be more easily analyzed and

17 understood. However, organic farming is

18 system-based and the methods used to study it

19 must follow suit if they are to open our view

20 to the interactions between different parts of

21 the system that make up a farm.

22 We request a change to the
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1 following language which we suspect will be

2 used in the future. Controversial, i.e.,

3 topics on which there are widely differing

4 perspectives in the independent scientific

5 community or for which there has been very

6 close NOSB votes, the addition being in the

7 yellow there.

8 Nine, we urge the board to remove

9 carrageenan from the list of research topics

10 for the simple reason that researchers funded

11 by the NIH and Veterans Administration already

12 provide answers to these questions.

13 Ten, we urge the board to add the

14 following language to the research priorities

15 proposal. When researchers answer the NOSB's

16 call to perform primary research on topics

17 that are listed as priorities the NOSB will

18 consider this research in its decision-making

19 process. NOSB members in their deliberations

20 will also take into consideration the funding

21 source of research that is presented,

22 especially when research is funded by entities
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1 with a financial stake in the outcome of the

2 research. 

3 Eleven, organic farmers are faced

4 with serious, on-the-ground problems that must

5 be addressed by research. If the board is

6 committed to encouraging research funding it

7 needs to make a systematic attempt to poll

8 farmers on the ground about what they consider

9 to be research priorities.

10 Now, Michelle, I guess I gave you

11 the version that's one slide short of what I

12 made yesterday which means it's lost in the

13 drop box thing. So I'll just verbally state

14 the last slide but we don't have a slide for

15 it.

16 We received two additional

17 comments after the docket closed and I want to

18 read them into the record. One of them was

19 from the FMC Company. We urge the board to

20 remove carrageenan from the list of research

21 topics for the simple reason that researchers

22 have already provided the answers to all the
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1 questions and found carrageenan to be

2 perfectly safe.

3 The next one that was verbal

4 comments from our colleague Mark Lipson on our

5 conference call was that the research topics

6 would be more useful to funders of organic

7 research if we provided direct links for each

8 topic to which of the criteria they addressed

9 so that funders who have set criteria can say

10 here is a direct link from this criteria to

11 this topic. 

12 And then additionally that we

13 prioritize the topics within -- we ask each

14 committee to prioritize the topics and then we

15 put the whole list of committee priorities

16 together as one. But he suggested we

17 prioritize within the committee's top

18 priorities. 

19 So those are the main public

20 comment that we received. Thank you.

21 MS. TAYLOR: Are there any

22 comments or any discussion? Nick?
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1 MR. MARAVELL: Yes, on comment

2 number 11 about hearing from farmers on the

3 ground as to their research priorities. I was

4 wondering if that type of information is

5 available through OFRF. I was, well, thinking

6 that perhaps the committee may have looked

7 into that. Or perhaps anyone in the audience

8 or anyone else? I mean, OFRF in the past has

9 asked about research priorities. I was just

10 wondering if that was part of -- no? Okay. 

11 End of question.

12 MS. SONNABEND: I think it is

13 appropriate to ask the board if based on any

14 of this public comment we want to make any

15 changes to our posted document, such as the

16 suggestion to remove methionine research on

17 meat byproducts or such as to add that yellow

18 clause into our criteria. Well, yes, we

19 received comment on both sides of carrageenan. 

20 MS. TAYLOR: John, go ahead.

21 MR. FOSTER: I have a question. 

22 What do you think about the research that
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1 someone says is already done around

2 carrageenan? Zea, what do you think about

3 that?

4 MS. SONNABEND: I think the fact

5 that we heard exactly almost to the word the

6 same thing from both sides, that all the

7 research questions were answered one way and

8 all the research questions were answered the

9 other way indicates it should stay on the list

10 of research topics because not everyone agrees

11 on the answers.

12 MR. FOSTER: Or rather everyone

13 agrees on the advice but in a totally opposite

14 direction, right? Okay. 

15 I do have one more, actually. All

16 the conversations we had -- you know what? 

17 I'm going to stop myself again. I'm good. 

18 I'm getting better at that. I think it's a

19 function of getting older, actually. It's the

20 only good thing I can find. So I'm going to

21 hold off on that. Thank you.

22 MS. TAYLOR: Okay, so we will
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1 introduce the motion. Okay. Yes, I'm sorry,

2 Colehour.

3 MR. WALKER: Thank you and thank

4 you for your work. I guess I want to for the

5 sake of this being in the record just comment

6 about my own personal perspective. I haven't

7 been directly involved in this. 

8 And I guess since this is a new

9 conceptualization which I actually think is a

10 very good idea and a much-needed idea for us

11 to be making use of. I don't at all mean to

12 come across negatively but I want to ask if

13 it's discovered as was referred to and as is

14 being raised after the NOSB has made a

15 decision about a topic, it's identified that

16 perhaps we don't have the research in place,

17 and realistically and honestly that means it

18 wasn't in place to have made a decision, then

19 it's a little bit confusing that therefore

20 we're going to decide that we need research

21 which from my understanding of a precautionary

22 principle we should have had in place before
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1 we made a decision. 

2 So I don't think it's a catch-22

3 commentary but I do want to raise that and ask

4 -- I mean, it relates back to some of these

5 topics that are on this current list. But I

6 think from a perspective of coming up with a

7 system that is functional for making use of

8 this idea of annually doing this I would like

9 to understand how we can address that or

10 incorporate that. And I'd like whatever the

11 subcommittee has internally discussed about

12 that shared. Thank you.

13 MS. TAYLOR: Go ahead, Zea.

14 MS. SONNABEND: Okay. Michelle

15 found the lost slide version and there's one

16 semi-housekeeping change to our posted

17 document that I would like to bring up.

18 When the Materials Committee

19 originally passed the document we had an

20 additional bullet point for carrageenan that

21 was suggested within our handling committee by

22 Jean although she missed the call when we
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1 voted on it. But we would like to -- because

2 this was already voted as a research topic we

3 would like to add it to our final document,

4 and that is what are the ecological impacts of

5 seaweed cultivation and harvest in species

6 used for carrageenan.

7 MS. TAYLOR: Okay, thank you. So

8 do we have a motion to adopt the proposal on

9 the NOSB research priorities with the

10 recommended change? Yes, Zea.

11 MS. SONNABEND: I'll move to adopt

12 the recommended research priorities. Oh,

13 sorry. 

14 CHAIRPERSON FLAMM: Jennifer, we

15 also failed. We're supposed to by each

16 subcommittee to do our recusal thing and we

17 didn't do it.

18 MS. TAYLOR: Okay, you're right.

19 CHAIRPERSON FLAMM: I'll let you

20 conduct that before we move to the motion.

21 MS. TAYLOR: Are there any

22 conflicts of interest here? Okay, none being
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1 reported let us proceed.

2 CHAIRPERSON FLAMM: Okay. Thank

3 you, Jennifer. The Materials Committee has a

4 proposal by the consideration of the full

5 board. Is there a motion that the Materials

6 Committee would like us to entertain?

7 MS. SONNABEND: Well, I'll make

8 the motion but it's the wording in the posted

9 proposal that I don't have in front of me. 

10 CHAIRPERSON FLAMM: And are you

11 going to -- the motion, will that include the

12 amendment that you just gave?

13 MS. SONNABEND: Yes. 

14 CHAIRPERSON FLAMM: Okay.

15 MS. SONNABEND: The motion is to

16 adopt the proposal on NOSB research priorities

17 with the amendment to add a bullet point to

18 carrageenan saying what are the ecological

19 impacts of seaweed cultivation and harvest in

20 species used for carrageenan.

21 CHAIRPERSON FLAMM: Is there a

22 second to the motion?
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1 MR. WALKER: Second.

2 CHAIRPERSON FLAMM: The motion has

3 been seconded. The motion is accept the

4 proposal on NOSB research priorities that's

5 been -- as amended as read by Zea, if that's

6 satisfactory. I don't have the exact language

7 in front of me but is everybody clear on what

8 the motion is? Any questions about what the

9 motion is? 

10 Okay, the motion has been made and

11 seconded. Discussion on the motion? John.

12 MR. FOSTER: Just, I'm fine with

13 the language of this but when it comes up kind

14 of with an eye towards traditional

15 sustainability criteria I would just ask that

16 the conversation at some point drift around to

17 also the economic impact of seaweed

18 cultivation and harvest in those areas. It

19 seems appropriate to me not -- I don't want to

20 change the language, I'm fine with that, but

21 that was something that wasn't particularly

22 well discussed. Actually it wasn't discussed
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1 at all as far as I can recall in our

2 discussions. 

3 And when we were talking about

4 adding this component to the research

5 priorities I think it's reasonable to in our

6 discussion have the conversation, what is the

7 economic impact of these activities,

8 particularly because they're not generally

9 well covered in our checklists either going

10 forward. I just think it's fair, that's all. 

11 What does it do for the community

12 economically. It may not be critical for this

13 particular topic but it can be for other

14 materials in front of the board. 

15 CHAIRPERSON FLAMM: Sounds like

16 something that you're suggesting for future

17 research?

18 MR. FOSTER: No, just on this

19 particular issue there's ecological impacts to

20 the cultivation and harvest. I think we need

21 further exploration on that. But I would hope

22 that the conversation would also include a
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1 discussion of the economic value of that

2 activity to those as well when we talk about

3 it. I don't want to add it, I don't want to

4 go through that process, but I want to be

5 mindful that there's many sides to every

6 activity and economics is one of them.

7 CHAIRPERSON FLAMM: Any other

8 comments, discussion? Hearing none we can

9 proceed with the voting beginning with Joe.

10 MR. DICKSON: Yes. 

11 MS. RICHARDSON: Yes.

12 MR. WALKER: Yes.

13 MR. BONDERA: Yes.

14 MS. TAYLOR: Yes.

15 MR. MARAVELL: Yes.

16 MR. FELDMAN: Yes.

17 MS. SONNABEND: Yes.

18 MR. STONE: Yes, sir.

19 MS. FULWIDER: Yes.

20 MR. AUSTIN: Yes.

21 MS. FAVRE: Yes.

22 MS. BECK: Yes.
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1 MR. FOSTER: Yes.

2 CHAIRPERSON FLAMM: And the chair

3 votes yes. That's 15 yes, zero no. The

4 motion passes. 

5 I believe that concludes our

6 meeting for today and we can recess until 8

7 o'clock tomorrow morning. Thank you,

8 everyone.

9 (Whereupon, the foregoing matter

10 went off the record at 5:30 p.m.)

11

12

13

14

15

16

17

18

19

20

21

22
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A

AAC 309:1

abbreviate 308:14

ability 80:7 101:20

157:9 211:12

233:16 257:4

359:6

able 5:3 7:13 37:16

63:1 78:19 96:3

107:6 115:8

120:19 121:2,7

129:14 159:9

165:8 167:10

171:6 187:10

188:12 191:15

230:6 243:16

269:22 271:12

275:12 285:10

289:5 343:13,20

349:11 353:19

370:8

absence 49:8 131:2

absent 119:13,15

absolute 125:13

273:12

absolutely 11:11

17:16 54:11

243:19 250:6

271:16

abstained 144:12

ACA 19:1

academia 232:16

acari 83:19

acaricide 82:19

83:18 368:12,19

ACAs 234:10

accelerated 233:17

accept 33:12 92:3

151:18 285:17

297:12 364:5,7

396:3

acceptable 163:18

329:6 338:20

364:11 385:3

accepted 73:16

103:5 247:8,12

338:18 365:16

access 9:12 53:1

54:12 73:19 74:5

74:11 201:1 219:5

accessible 74:2

accessing 24:1

200:2

accompanied 52:21

159:6

accomplished

22:19

accreditation

234:15

accredited 42:1

250:16

accurate 76:2

accurately 371:11

achievable 33:11

achieve 39:3

129:10 339:19

acid 3:12 76:18

77:7,9 78:9,12

81:5 117:8,12,15

117:21 119:19

282:19 293:7

309:16 375:14,17

375:19 376:2

377:3,11

acids 76:20 78:14

79:1 119:3,3

282:21 283:6,6

358:11 363:9,17

365:1,11

acknowledge 8:13

56:17 135:18

137:6 200:16

ACOA 8:14,22

acquainted 224:9

acre 162:18 230:3

acreage 201:9

202:1 229:16

299:6,11 303:10

350:19 354:10

acreages 61:5

acres 152:12 154:4

165:6 261:15

316:10,14 350:19

act 41:12,14 42:16

47:18 87:8 90:5

173:2,9,12 192:12

220:3

acting 173:11

action 38:8 107:5

actions 23:21 38:9

125:20 137:6,11

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2015 112:16

2016 108:3 112:3

157:7 168:10

333:21

2017 69:10 95:7

363:11,19 364:1,3

364:4,21 365:2,14

365:21

203(c)(1) 317:15

205.105 295:3

205.206 140:20

370:18

205.206(c)(6)

273:17

205.601 76:14

82:18 89:6 117:15

123:4 124:6

377:11

205.601(b) 123:8

205.601(b)(2)

125:4

205.601(e) 83:16

368:12,18

205.601(h) 67:2

356:4,10

205.601(j) 377:2

205.601(j)(3) 76:20

363:8 365:11

205.601(m) 69:4

321:19

205.601(3) 363:17

205.602 104:20

108:2 330:17

205.670 11:21

21 3:4 364:4,21

22 76:10 365:21

221 3:19

23 205:6

24 82:13

25 146:14,16,19

200:11 224:1

227:10

25(b) 90:5 93:19

94:6 102:7,10,13

250 165:14

26 7:2,9 68:16,17

26th 122:22

27 117:13 150:3

365:2,2,13,21

28 152:17

3

3 14:5 73:5 87:14

95:8 96:11 108:4

116:21 141:8

202:10,13,18

224:4 228:3 234:1

305:8,11 310:7

327:8 328:6

334:19 341:6

351:1 357:14

3(1) 245:21

3,000 15:15 42:7

352:4

3,000-seed 12:11

22:16

3-year 332:21

333:1

3-4 262:13

3.5 377:5,13

3:29 322:19

3:44 322:20

3:45 322:13

30 206:19 216:10

281:3 320:10

351:16

34 152:16

354 3:20

365 351:21

378 3:22

38 124:15 350:19

385 351:18

394 3:23
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4

4 3:3 14:14 68:17

96:11 160:19

181:5 223:17

224:2 305:8,11

310:7 313:17

318:11 320:16

321:12 340:18

345:17

4(a) 87:11

4(b) 87:11

4.3 246:13 247:10

4.5 377:4,12

40 204:7,11 206:16

298:6 351:12

400 165:6

42 237:3

421 308:14

43 150:3 201:9

437 202:7

445 308:18

48 201:12

488 309:15 5 65:22 68:18 69:6

73:5 104:1 141:21

160:19 163:3

192:11 221:2

372:14

5,000 330:12

5-year 95:6

5:30 399:10

50 309:17 350:15

351:17

50,000 153:5

503 242:10

52 223:22

545 250:16

57 105:13 208:11

592 309:4

595 309:8

5988 125:16 127:18

233:12 285:12

5998 296:18 297:3 6

6 18:17 91:10

119:15 130:11

149:22 181:5

226:13 234:1

334:19

6(d)(2) 245:22

6-0 119:13

60 201:11 203:7

255:21

601 90:1

602 341:19

603 89:6 90:1

6400 130:21 139:12

233:11,19,22

285:8,22 296:3,18

296:20 297:6,9

649 307:5 309:14

65 3:6

650 272:9

652 309:15

66 3:8 6:13

67 167:9

6866 128:4

69 202:7

7

7 6:15 8:20 66:21

166:12 254:18

363:8,17 365:10

366:18

7-acre 223:20

70 205:11

73 167:6 205:4

75,000 329:18

76 3:9

79 6:16

8

8 19:5 66:1 150:2

237:4 366:18

399:6

8:00 1:10

8:04 4:2

80 207:4

82 3:9

85 10:5

86 3:10

889/2008 245:22

9

9.7 152:13

9:08 65:10

9:20 65:7

9:31 65:11

90 125:13 127:12

127:16 132:2,14

166:14 233:16

236:6 241:21

273:12

93 167:16

95 17:9 330:9
NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 

1323 RHODE ISLAND AVE., N.W. 

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 

C E R T I F I C A T E

This is to certify that the foregoing transcript 

In the matter of: 

Before: 

Date: 

Place: 

was duly recorded and accurately transcribed under 

my direction; further, that said transcript is a 

true and accurate record of the proceedings. 

 

 ----------------------- Court Reporter 

456

Meeting of the National

Organic Standards Board

USDA

10-16-12

Providence, Rhode Island
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 UNITED STATES DEPARTMENT OF AGRICULTURE

 AGRICULTURE MARKETING SERVICE (AMS)

 NATIONAL ORGANIC PROGRAM (NOP)

 + + + + +

 MEETING OF THE NATIONAL ORGANIC

 STANDARDS BOARD (NOSB)

 + + + + +

 WEDNESDAY

 OCTOBER 17, 2012

 + + + + +

 The National Organic Standards Board

convened at 8:00 a.m. at the Biltmore Hotel,

11 Dorrance Street, Providence, Rhode Island,

Barry Flamm, Chairperson, presiding.

MEMBERS PRESENT:

BARRY FLAMM, Chairperson

HAROLD AUSTIN

CARMELA BECK

COLEHOUR BONDERA

JOSEPH DICKSON

TRACY FAVRE

JAY FELDMAN

JOHN FOSTER

WENDY FULWIDER

NICHOLAS MARAVELL

JEAN RICHARDSON

ZEA SONNABEND

ROBERT STONE

JENNIFER TAYLOR

CALVIN WALKER
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STAFF PRESENT:

MILES McEVOY, Deputy Administrator, National 

 Organic Program

MICHELLE ARSENAULT, Advisory Board Specialist

MELISSA BAILEY, Director, Standards Division,

 National Organic Program

LISA BRINES, Standards Division, National 

 Organic Program

EMILY BROWN-ROSEN, Agricultural Marketing 

 Specialist

JENNIFER TUCKER, Associate Deputy 

 Administrator 
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 A G E N D A

Handling Subcommittee . . . . . . . . . . . . .4

Panel Presentations/Questions

Dr. Sue Anderson and Dr. Jatinder Bhatia. . . 22

Public Commenters . . . . . . . . . . . . . .100

Panel Questions . . . . . . . . . . . . . . .238

Policy Development Subcommittee . . . . . . .316
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1 P-R-O-C-E-E-D-I-N-G-S

2 8:05 a.m.

3 CHAIRMAN FLAMM: Good morning

4 everyone. We're ready to go. The meeting is

5 in order. Board members, please take your

6 seat. This morning we start off with the

7 Handling Subcommittee. John Foster is chair. 

8 John, I'll pass the gavel to you to conduct

9 this session.

10 MR. FOSTER: Thank you, Barry. 

11 This is a virtual gavel, I assume. The

12 virtual gavel. That's right. You can hang

13 onto that. I'll be inventive. So welcome

14 back everybody. Thank you for coming back. 

15 We've got several materials to,

16 all petition materials in one discussion

17 document to go over this morning. I believe

18 our standard protocol will be back in place,

19 with Lisa Brines presenting proposals and

20 summarizing presenting proposals.

21 We will then have, we'll have

22 representatives from the American Academy of
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1 Pediatrics and the FDA, to be available to

2 respond to some member questions, which we

3 presented to them ahead of time. 

4 We'll have some public comment. 

5 We will break to modify proposals, if needed,

6 and then later after lunch, we'll be going

7 into votes. I anticipate we'll need to scoot

8 one or two materials to tomorrow, maybe more. 

9 But hopefully, we can get through most of them

10 today. That would be my preference.

11 So I'm following Jay's lead on

12 being efficient and expeditious. We'll try

13 and move fairly quickly with -- so we have

14 one, two, three, seven, eight proposed

15 petition materials, and then one of the

16 discussion documents. 

17 I'd like to proceed in order as

18 they're on the agenda, and if there's --

19 unless there's other things to clarify, we'll

20 just move forward on the first item after. I

21 asked members of the Board to take a look at

22 that list of materials, and if you have any
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1 disclosures of interest you'd like to make at

2 this time on any of those materials, now would

3 be the time to do it.

4 (No response.)

5 MR. FOSTER: All right. I think

6 we're good. So Lisa, are you ready to roll? 

7 Then take it away.

8 MS. BRINES: Good. Thanks, John. 

9 First petition of the morning is ascorbyl

10 palmitate. This petition was received on

11 August 29th, 2011, and was submitted by the

12 International Formula Council. 

13 The petition requests the

14 inclusion of ascorbyl palmitate to Section

15 205.605(b) of the National List, for use as an

16 antioxidant in infant formula. In support of

17 its review the Handling Subcommittee did

18 request the development of a new technical

19 report, and both the report and the petition

20 were made available on the NOP website in

21 advance of the opening of the public comment

22 period for this meeting.
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1 Written public comment was

2 received on this substance, and a

3 representative for the petitioner is signed up

4 for in-person public comment later this

5 morning. Thank you.

6 MR. FOSTER: Thank you, Lisa. 

7 Nick, I believe you were headmaster of this

8 material. Would you take it from here?

9 MR. MARAVELL: Thanks. First in

10 the morning? Boy, all right. I'm going to --

11 I don't have any slides for the audience, but

12 what I'd like to do is summarize briefly some

13 of the comments that we have received, and

14 just note that there, we have basically two

15 types of arguments, if you will, being made.

16 One is primarily coming from a

17 consumer perspective, that synthetics in

18 infant formula are not the most desirable

19 additive. On the other side of the comments,

20 and those are coming primarily from industry,

21 is that ascorbyl palmitate is a very useful

22 synthetic in infant formula, because it has
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1 some unique characteristics.

2 One of them is that it is fat3 soluble, and it can serve as an antioxidant

4 and function as a preservative, to preserve

5 the essential oils that are added to infant

6 formula, and also that it is heat-tolerant,

7 such that during the manufacturing process it

8 maintains its abilities, whereas some other

9 antioxidants may not have that same

10 capability.

11 There was also some discussion

12 with regard to rosemary extract. The

13 petitioner was saying that rosemary extract

14 was an untested, unproven antioxidant and

15 preservative, and that it could have unknown

16 and harmful effects.

17 There were no citations for this,

18 but the committee did attempt to research it,

19 and there was nothing in the TR to

20 substantiate harmful effects in infant

21 formula. So while that claim is out there, it

22 is true that rosemary extract is not a long-
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1 term tested addition to infant formula.

2 However, I think we noted that

3 with the case of ARA and DHA, it is -- in our

4 approval process it was permitted to be used

5 with those additives as well. 

6 Ascorbyl palmitate is an approved 

7 source of Vitamin C, and can be added for that

8 purpose, and I'd just like to make it clear

9 that that's not what we're voting on here. 

10 We're voting on here as to whether ascorbyl

11 palmitate is indeed appropriate for its use as

12 an antioxidant and as a preservative.

13 There has been some discussion

14 that there is a distinction between an

15 antioxidant and a preservative. The

16 distinction would follow along the lines of an

17 antioxidant used during the manufacturing

18 process is indeed to establish the stability

19 and functionality of the formulation, whereas

20 a preservative would be sort of added to, and

21 I'm simplifying it here, would be added to

22 sort of extend the shelf life of the product.
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1 Now in consulting with the TR, we

2 definitely found statements that there is no

3 use of ascorbyl palmitate in processed food

4 for nutrient value, and that without the use

5 of ascorbyl palmitate, it would definitely --

6 well the use of ascorbyl palmitate was to

7 prevent rancidity, and therefore extend the

8 shelf life of a product.

9 So we may further explore that

10 distinction between antioxidant and

11 preservative. However, the TR is rather clear

12 that it functions as a preservative, and

13 indeed most antioxidants are preservatives. 

14 That's the nature of an antioxidant.

15 I'm not sure I need to go any

16 further. I'm going to see if there's anybody

17 else that has any further comments from the

18 committee on ascorbyl palmitate.

19 MR. FOSTER: If you could kind of

20 summarize the subcommittee's votes.

21 MR. MARAVELL: Summarize the vote?

22 MR. FOSTER: Yes.
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1 MR. MARAVELL: Of the

2 subcommittee?

3 MR. FOSTER: Of the subcommittee,

4 yes.

5 MR. MARAVELL: The subcommittee,

6 on the motion to list ascorbyl palmitate,

7 voted unanimously. There was one absent, not

8 to list ascorbyl palmitate. So it was a

9 unanimous vote in that regard. Anything else

10 I may have left out, John? Anyone else on the

11 committee think that we should raise

12 additional issues? 

13 MS. SONNABEND: Well, this is the

14 point where I'd like to ask questions of our

15 experts. Is that appropriate?

16 Chair?

17 MR. FOSTER: It's fine with me. I

18 wanted to kind of check with the program, if

19 it's preferable to do in one big block, or is

20 it preferable to do one-offs.

21 MS. BRINES: We're happy to go

22 along one by one, as you go through this. We
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1 do need to introduce the speakers for the

2 courtesy of the audience, who doesn't know

3 their background as well. So we're prepared

4 to do that if this would be an appropriate

5 time. Thanks. 

6 MR. FOSTER: Okay.

7 CHAIRMAN FLAMM: John, we decided

8 the procedures and agreed that the chair could

9 make that determination, if given the -- if

10 the chair knows what, who it is and whether

11 there's any, you know, Board dissent about

12 getting, make sure we get all points of view

13 and not biased to the questioning. 

14 So but it's -- you can make that

15 call, but I think the Board ought to know just

16 who we're calling for. 

17 MR. FOSTER: So in our

18 conversations we've had in the previous few

19 days, it sounds like beta carotene, we might

20 have some of the same kind of questions. Can

21 we get through beta carotene and then ask our

22 guests to speak on both at the same time?
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1 MS. SONNABEND: As long as we go

2 back and discuss the previous one, if we need

3 to.

4 MR. FOSTER: Yes. Unless there's

5 an objection, let's go that way. All right,

6 let's go that way. Thank you, Nick. Was

7 there any other questions on, that we need to

8 get to on ascorbyl palmitate right now from

9 the Board? 

10 (No response.)

11 MR. FOSTER: All right. Thank

12 you, Nick. Next, we'll do beta carotene. 

13 Tracy, our point on that. Would you take the

14 pointer? I'm sorry, Lisa. I didn't see you. 

15 MS. BRINES: Thanks, John. The

16 petition for beta carotene was received on

17 October 11th, 2011 and was submitted by the

18 International Formula Council. The petition

19 requests the inclusion of synthetic beta

20 carotene to Section 205.605(b) of the National

21 List as an ingredient in infant formula.

22 There is one other listing for
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1 beta carotene on the National List, which is

2 on 205.606, as an agriculture ingredient. 

3 That's the form of beta carotene extracted as

4 an extract color derived from carrots. So

5 it's distinct from this form that's being

6 petitioned.

7 In support of its review, there

8 was two technical reports available for the

9 substance. There's one that was prepared in

10 2011 in response for the petition for beta

11 carotene color, and in support of its review

12 for this petition, the Handling Subcommittee

13 had requested an updated or supplemental

14 technical review, which was developed.

15 Both of those two previous

16 technical reports for beta carotene, as well

17 as the petition, were available to the public

18 on the NOP website in advance of the opening

19 of the public comment period. And again, the

20 petitioner has signed up for in-person public

21 comment later this morning. Thanks.

22 MR. FOSTER: Thank you, Lisa. 
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1 Tracy.

2 MS. FAVRE: Thanks, Lisa. Thank

3 you, Nick, for sort of laying the same

4 groundwork. We had essentially the same

5 cluster of categories of comments for beta

6 carotene as we had for ascorbyl palmitate. 

7 There were pretty passionate comments for

8 diametrically opposed positions for the

9 substance.

10 It is being petitioned as

11 synthetic beta carotene, and we had some

12 questions that we posed to some experts about

13 the requirement for synthetic, specifically in

14 use in infant formula, and hopefully we'll get

15 some more clarification on that this

16 afternoon.

17 The petition specifically talks

18 about synthetic beta carotene as a lipid

19 stabilizer in the formulas, and even though it

20 does have nutritional value as a provitamin,

21 it also is being petitioned for use as a

22 preservative.
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1 As a result, after much discussion

2 back and forth and actually some, needing to

3 get some clarity around the fact that if we

4 declined to list it as petitioned, it still is

5 likely to be used as a vitamin source in

6 infant formula.

7 So and I'm sure that's probably

8 not clear. Some of the public commenters

9 specifically were concerned that we were going

10 to refuse the use of beta carotene or

11 specifically Vitamin A in infant formula, and

12 that's not likely to be the case, regardless

13 of where the vote comes on this today.

14 So in summary, we did vote as a

15 subcommittee to list it as synthetic, since it

16 was specifically petitioned for that, and

17 secondly on the listing motion, it was a

18 unanimous vote to decline to list.

19 But we have had some further

20 discussion, based on not only some of the

21 public comments, but also conversations among

22 the subcommittee, and we want to get some
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1 clarity during the question and answer session

2 with the FDA and AAP experts that will speak

3 to us today.

4 MR. FOSTER: Thank you, Tracy, and

5 thank you for that good timing. Appreciate

6 that. Are there any other questions from the

7 Board before we ask our guests to come up? 

8 All right. With that, Lisa, would

9 you introduce our guests?

10 MS. BRINES: Sure. Thanks, John. 

11 Yes, in support of the Board's deliberation

12 this morning, we had invited two technical

13 experts in this subject area to be available

14 for questions from the Board that might come

15 up as a result of the deliberations, and we're

16 lucky to have two of them available here

17 today.

18 Our first invited speaker is Dr.

19 Jatinder Bhatia, who is the current chair of

20 the American Academy of Pediatrics Committee

21 on Nutrition. Dr. Bhatia is a graduate of the

22 Armed Forces Medical College of the University
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1 of Pune, India. 

2 He completed his pediatric

3 residency, including a year as chief resident,

4 at the Medical College of Georgia in Augusta,

5 followed by a joint fellowship in Neonatology

6 and Pediatric Nutrition at the University of

7 Iowa.

8 From there, he joined the faculty

9 of the University of Texas Medical Branch in

10 Galveston, in the Departments of Pediatrics

11 and Preventative Medicine and Community

12 Health. He also held a joint appointment at

13 the University's graduate school of biomedical

14 sciences.

15 In 1991, Dr. Bhatia returned to

16 the Medical College of Georgia as a professor

17 of Pediatrics. Three years later, he was

18 named Chief of the Division of Neonatology and

19 Program Director in Neonatal, Perinatal

20 Medicine Fellowship, and he is also a

21 professor in the Medical College of Georgia

22 School of Graduate Studies.
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1 Dr. Bhatia's areas of research

2 include a wide variety of neonatal issues

3 including neonatal nutrition and total

4 parenteral nutrition. His research has been

5 supported by the National Institutes of

6 Health, industry and foundations. He's the

7 author of more than 100 articles, abstracts

8 and book chapters, and has edited two books

9 and he has made presentations of his work

10 nationally and internationally.

11 He's a member of a number of

12 different societies in terms of pediatric

13 research and nutrition. He's an active

14 reviewer for numerous journals and serves as

15 an associate editor for a number of journals

16 as well. So I thank him for making the trip

17 to meet with us today.

18 Our second invited speaker is Dr.

19 Sue Anderson. Since 1996, Dr. Anderson has

20 served as the team leader for Infant Formula

21 Regulation at the Center of Food Safety and

22 Applied Nutrition at the Food and Drug
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1 Administration.

2 She also serves as the technical

3 expert for international issues in pediatric

4 nutrition for Codex Alimentarius committees. 

5 Prior to joining FDA in 1996, for 18 years she

6 worked at the Life Sciences Research Office of

7 the Federation of American Societies for

8 Experimental Biology in Bethesda, Maryland.

9 During her tenure with the Life

10 Sciences Research Office, she worked with the

11 Select Committee on GRAS Substances, and the 

12 review of health aspects of food ingredients,

13 and she directed studies by expert panels for

14 the issues related to nutrition, food safety

15 and diet health relationships.

16 Dr. Anderson has a Bachelor of

17 Science degree in Food and Nutrition from the

18 University of Illinois, a Master's degree in

19 Food Science from Auburn University, and a

20 doctorate in Human Nutrition from Purdue

21 University. I thank Dr. Anderson for being

22 available for questions today. Thanks.
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1 MR. FOSTER: Thank you, Lisa. So

2 let me just remind Board members we, as a

3 group in the Handling Subcommittee, we had

4 generated a number of questions beforehand,

5 and came to pretty good agreement that that

6 was a good encapsulation of a number of the

7 questions that we wanted to ask our guests

8 today.

9 So let's start with those. I'd

10 like to also, out of kind of respect for the

11 petitioners and the audience, as well as

12 keeping track of our own time, let's make sure

13 we're targeting these questions on the

14 petition materials at the moment.

15 This is why we have the guests

16 here, so we want to kind of focus on that as

17 much as we can. Every once in a while, I'll

18 be reminding everyone that we have a break at

19 ten, and we need to get through all of the

20 materials. At least at this time, we need to

21 sort through all of them in a relatively short

22 time. 
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1 So keep it focused, and I'll try

2 my best to remind us all of that. So with

3 that, could we have our guests, Zea? I think

4 we want to move into questions around ascorbyl

5 palmitate and beta carotene. Doctors, could

6 you come on up to the podium? 

7 DR. ANDERSON: Good morning. 

8 MS. SONNABEND: Good morning.

9 MR. FOSTER: Zea?

10 MS. SONNABEND: So as we're

11 considering these two compounds, which have a

12 number of similarities and some differences,

13 we'd like it if you could just clarify for the

14 Board the distinction between what is referred

15 to as an antioxidant and a preservative, and

16 then how people that talk about synergistic

17 effects of antioxidant, and if you could just

18 talk about that, how the different ones would

19 be synergistic?

20 DR. ANDERSON: Okay. Well,

21 preservatives can be a broad spectrum of

22 compounds. They can be added. Antioxidants
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1 would be a subcategory. Other preservatives

2 are added to retard spoilage in bread, for

3 example. But the antioxidants are a class of

4 compounds that have preservative products by

5 acting as antioxidants.

6 With regard to the synergistic

7 effect of antioxidants, the role of

8 antioxidants in food depends on the

9 characteristic of the food, the characteristic

10 of the antioxidants that are used, and the

11 storage conditions of the foods, the length of

12 time it needs to be preserved, and all of that

13 is a very complicated chemical process.

14 There's a huge literature on the

15 effects of mixtures of antioxidants. Specific

16 antioxidants can have multiple roles in

17 different food matrices, and they can act

18 differently in different food matrices.

19 The mechanisms of action under

20 specific circumstances need to be understood

21 before there can be any discussion of how they

22 interact, and you would have to know the
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1 specifics of the specific antioxidant system

2 you're talking about, and the specific matrix. 

3 So really, I can't comment any further than

4 that.

5 MR. FOSTER: Other questions from

6 the Board on the materials? Zea?

7 MS. SONNABEND: So are, and if you

8 have a different perspective on that, we would

9 also --

10 DR. BHATIA: No, I don't. Thank

11 you, first of all, for having me represent the

12 AAP. One of the things we have to understand,

13 I'm sure this audience knows very well, that

14 all these additions or subtractions or

15 approvals or otherwise have come from many,

16 many years ago, and back then, the only issue

17 was safety/efficacy of the added compound.

18 Only now have we added

19 functionality and outcome measures. So these

20 two components, for example, have been shown

21 to be safe, but mainly they are added for

22 manufacturing purposes, not to show any
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1 efficacy or effect in the neonate.

2 None of that antioxidants have

3 really been studied to say "If I add this

4 mixture, I'm going to have outcome X in the

5 baby." These are all manufacturing issues

6 that started off in the first place.

7 MS. SONNABEND: Okay, thank you. 

8 Our next question has to do with it's similar. 

9 Both of these two compounds have shown vitamin

10 activity, and can be used as sources of

11 vitamins.

12 We'd like to confirm that these

13 are both recognized sources of vitamins, beta

14 carotene for Vitamin A and ascorbyl palmitate

15 for Vitamin C, and then we received some

16 public comment that the beta carotene quantity

17 that's used routinely for vitamin activity

18 would be sufficient for the antioxidant

19 effect. 

20 In other words, it's like 250

21 units would be used for vitamin activity, but

22 only 20, I don't have the exact figures, but
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1 only 20 are needed for antioxidant effect, and

2 we would like to hear from you concerning the

3 relative quantities of their use as a vitamin,

4 versus an antioxidant.

5 DR. BHATIA: Again, clinically the

6 use of Vitamin A has been more as a vitamin

7 for other issues like night blindness and the

8 effect of mortality globally if there's a

9 Vitamin A insufficiency.

10 Approximately 85 percent of the

11 global population, as covered by the current

12 standards, have Vitamin A added into infant

13 formulas and foods. It is a minority of the

14 population that has a deficiency.

15 We're still struggling with this,

16 especially with the confounding variable of

17 malaria, which we don't have in the United

18 States. So yes, it's a source of Vitamin A. 

19 Yes, what we have currently in the Infant

20 Formula Act is sufficient for the purposes put

21 in.

22 It was not put in there at that
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1 time as an antioxidant. It was put in there

2 as a vitamin by itself, because we knew the

3 vitamins are important for development of

4 babies.

5 MS. SONNABEND: But would the

6 amount put in as a vitamin be enough for the

7 antioxidant activity?

8 DR. ANDERSON: Perhaps I can

9 clarify on that. Vitamin C is added to infant

10 formulas as a source of -- ascorbic acid is

11 added as a source of Vitamin C.

12 Ascorbyl palmitate is added as an

13 antioxidant. In order for the ascorbyl

14 palmitate to be used as a source of Vitamin C,

15 the palmitate and the ascorbic acid would have

16 to be cleaved apart.

17 That is less efficient than

18 providing Vitamin C as such, and infant

19 formula manufacturers add ascorbic acid as the

20 source of Vitamin C for the infant, in the

21 infant formula. Now with Vitamin A, infant

22 formula manufacturers add pre-formed Vitamin
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1 A as the Vitamin A source in the formula.

2 They do not rely at all on the

3 beta carotene that is added. The beta

4 carotene is added as an antioxidant in the

5 formula, and like I said, they do not rely on

6 the beta carotene as a source of Vitamin A for

7 the infant.

8 MS. SONNABEND: Thank you.

9 MR. FOSTER: Tracy.

10 MS. FAVRE: Okay. Just to clarify

11 that statement, so pre-formed Vitamin A is

12 already added to infant formula, and therefore

13 meets the vitamin requirements for Vitamin A. 

14 Beta carotene is specifically used as an

15 antioxidant?

16 DR. ANDERSON: That's correct, for

17 formulations that are made at the current

18 time.

19 MS. FAVRE: Thank you.

20 MR. FOSTER: Nick.

21 MR. MARAVELL: Yes. Just to

22 clarify on ascorbyl palmitate. Vitamin C
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1 would normally be added with ascorbic acid

2 because, as you pointed out, it's more

3 efficacious to do so. So the amounts being

4 added to infant formula of ascorbyl palmitate

5 then are not an amount that would be a

6 consideration for a Vitamin C supplement. 

7 It's added solely as an antioxidant.

8 DR. ANDERSON: That's correct.

9 MR. MARAVELL: Thank you.

10 MR. FOSTER: Thank you. Last

11 questions on either of the two materials? 

12 Zea? 

13 MS. SONNABEND: Okay. Well, this

14 is Question 5 on the questions we sent you,

15 which I may not have phrased exactly right. 

16 But our understanding is that these

17 antioxidants are used in the dry powdered

18 formula, which is created with a high heat

19 process and it's used to prevent rancidity of

20 the oils in the formula.

21 I was wondering if the rancidity

22 occurs right away when you make it, or if it's
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1 a question of shelf life later on, and if it's

2 the latter, how much shelf life would be lost

3 not using one of the antioxidants?

4 DR. ANDERSON: Okay. It's

5 necessary to provide heat during the

6 processing of infant formula, in order to make

7 it microbiologically safe. During the spray8 drying process, which I believe your question

9 was referring to, the infant formula is

10 exposed to heat, but it's also exposed to

11 oxygen.

12 So those two in combination can

13 lead to some oxidation of the product, if it's

14 not adequately protected by antioxidants. So

15 there will be some potential for oxidation,

16 not a whole lot, during the processing. There

17 will be also some potential for oxidation

18 during storage of the product. It's not a

19 lot, because it's stored under nitrogen, and

20 there's not a lot of exposure to oxygen.

21 However, because it's a powder,

22 there's a very large amount of surface area,
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1 and it can be -- there's a lot of potential

2 for interaction because of that large surface

3 area.

4 With regard to how much occurs at

5 this point and how much occurs at that point,

6 I'm not prepared to answer that, and if

7 there's somebody from industry that has that

8 expertise, they might be able to do so.

9 MR. FOSTER: All right. Tracy.

10 MS. FAVRE: So I guess we're back

11 to the question of whether or not the

12 antioxidant properties of the beta carotene or

13 the ascorbyl palmitate is absolutely necessary

14 in the manufacturing process, to ensure

15 product safety?

16 DR. ANDERSON: The fat sources

17 that are used in infant formula are used to

18 "mimic" the fat profile in human milk, and

19 that means that there are, is a fairly large

20 percentage of polyunsaturated fatty acids. 

21 Those are very subject to

22 oxidation, as are -- and in particular the
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1 long-chain polyunsaturated fatty acids, the

2 DHA and ARA, are very much subject to

3 oxidation.

4 They definitely need protection

5 during the manufacturing and storage process,

6 and the ascorbyl palmitate, beta carotene

7 tocopherols system has been shown to be

8 protective.

9 MR. FOSTER: I have Jean and then

10 Nick and --

11 MS. TUCKER: Wait. Can we pause

12 for just a moment? 

13 MR. FOSTER: Yes.

14 MS. TUCKER: You folks are going

15 to be up here for a little while. So I'd like

16 to invite you to sit down, so you're not

17 standing up all the time, okay.

18 MR. FOSTER: What fun is that?

19 (Laughter.)

20 MS. TUCKER: Okay. So we have

21 two mics here for you, and two chairs.

22 DR. BHATIA: Thank you.
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1 MS. TUCKER: Sure.

2 DR. BHATIA: One thing I would

3 like to add unasked about the heating process

4 for making powdered infant formulas, the

5 United States and all the world manufacturers

6 have bacterial counts and colony-forming

7 units, which is lower than the USDA and the

8 world standard.

9 Yet one is to understand, even

10 with the intense heat and drying process that

11 Dr. Anderson just described, infant powder

12 formula is not sterile. That is why we make

13 liquid formula and the cost will go up. 

14 That's a different issue

15 altogether. So having recognized that, if we

16 lowered the heat for other reasons, we run the

17 risk of having more bacterial colonization,

18 because bacteria do not get destroyed with

19 that amount of intense heat. It requires much

20 higher than that.

21 MR. FOSTER: Thank you. So Jean

22 and then Nick, and try and wrap it up after
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1 that.

2 MS. RICHARDSON: Yes. My question

3 relates to the shelf life of the infant

4 formula. If you did not add either the

5 ascorbyl palmitate or the beta carotene, what

6 difference would it make in the shelf life of

7 the infant formula?

8 DR. ANDERSON: It would definitely

9 be shorter, much shorter. But I don't have

10 quantitative. I can't say X months with and

11 Y months without. But definitely shorter and

12 one thing that you do not want in products for

13 infants is oxidized fat, or any other

14 deleterious substance.

15 MR. FOSTER: Nick.

16 MR. MARAVELL: Yes. This is less

17 of a question, a little bit more of a factual

18 insertion here, that in previous action, our

19 Board has permitted ascorbyl palmitate and

20 beta carotene. I believe both for

21 particularly an ARA/DHA product added to

22 infant formula.
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1 So in terms of ensuring the safety

2 of that specific fatty acid, I think we do

3 have an avenue for that particular fatty acid.

4 MR. FOSTER: All right. So I

5 think we'll wrap up questions on these two

6 materials, have the presentations on, it will

7 be lutein is up next.

8 But please, please make yourselves

9 comfortable and I'm sure there will be

10 additional questions, as far as some of the

11 other materials as we move through that. Is

12 that all right with you? You're our guests,

13 so we want to make sure you're comfortable. 

14 Thank you.

15 DR. ANDERSON: Sounds good.

16 MR. FOSTER: All right. Having

17 said that, Lisa in the spotlight. The next

18 material would be lutein.

19 MS. BRINES: Thanks, John. The

20 petition for lutein was received on November

21 14th, 2011, and was submitted by Kemin Health,

22 LLC. The petition had requested the inclusion
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1 of lutein at Section 205.606 of the National

2 List as an agricultural product, for use as an

3 ingredient in processed foods.

4 In support of its review, the

5 Handling Subcommittee requested the

6 development of a third party technical report. 

7 Both that report and the petition are

8 available to the public by posting on the NOP

9 website in advance of the opening of the

10 public comment period.

11 Written public comment was

12 received in support of this petition, and the

13 petitioner is signed up for public comment

14 later this morning. Thanks.

15 MR. FOSTER: Thank you, Lisa. 

16 Harold, you're lead on this. Would you take

17 it from here?

18 MR. AUSTIN: Okay. Thanks, John. 

19 Lutein, I'll just go through this and

20 abbreviate as much of it as I can. It's a

21 carotenoid related to beta carotene. It's a

22 strong antioxidant. This material has been
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1 petitioned to be added for use in infant

2 formula. Let's just state that right off, up

3 front.

4 It is naturally present in many

5 vegetables such as spinach, kale, broccoli,

6 green beans. The petition form of lutein is

7 derived from dried food grade marigolds, non8 organically raised. This is the primary

9 source to be used to be petitioned.

10 Lutein comprises the macular

11 pigment of the eye and is found in the lenses. 

12 Acts as a blue light filter and serves an

13 important role, according to what we've been

14 petitioned, in eye health. It also is

15 acquired only through one's diet and cannot be

16 synthesized by the body.

17 The primary source for lutein for

18 infants is human breast milk. The level of

19 lutein in human breast milk will vary,

20 depending on the dietary intake of the lutein21 rich vegetables by the infant's mother. This

22 will vary in different parts of the world due
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1 to cultural dietary eating habits.

2 Cow milk or soy-based infant

3 formulas would need to be fortified with

4 lutein, to equal the amounts normally found in

5 human breast milk. This ingredient is not

6 required by the FDA under 21 C.F.R.

7 104.20(d)(3). 

8 The petitioner has actually

9 requested for this material to be listed for

10 two uses. Number one, in organically labeled

11 infant formula, number two, in organic-labeled

12 foods. The Handling Committee decided that,

13 through deliberation, that there was adequate

14 source for the secondary petition request, and

15 have chosen not to vote upon that.

16 We felt that for adults, for use

17 in foods, that they could get that through

18 natural dietary habits. There is enough

19 alternate sources available. So the only

20 thing that we're discussed today would be the

21 addition of lutein to the list for use in

22 infant formula.
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1 This would technically fall under

2 the category of accessory nutrients, and

3 because of the actual method of production of

4 lutein is confidential business information,

5 the subcommittee could not verify that lutein

6 was considered, should be considered as a non7 synthetic, as requested by the petitioner.

8 In the TR, it was mentioned that

9 they felt that the formulation process would

10 classify this as a synthetic. The Handling

11 Subcommittee was split on the listing of

12 lutein for use in infant formula. The basis

13 of this vote and those voting in favor of

14 showed that the material is currently being

15 used in infant formulas.

16 Secondly, because the importance

17 of the role that it plays in eye health in

18 infants and adults. Those on the Subcommittee

19 that were opposed to the listing felt that it

20 was not mandated as an additive by the FDA for

21 use in infant formula, did not have enough

22 information because of the CVI version of the
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1 petition to determine whether it was a non2 synthetic or not.

3 It does not appear to be

4 essential, since it is in some brands, not in

5 others, and there appears to be a viable non6 synthetic alternative such as whey protein and

7 microayalgae sources.

8 The rationale behind the

9 Subcommittee choosing not to include the

10 petitioner's request for the second was as I

11 stated, that we felt that there was adequate

12 alternatives for that listing.

13 Committee vote on that listing

14 classification or the classification motion 

15 as a synthetic was 7 yes, 0 no, no absents. 

16 The listing motion to add lutein to the

17 National List 205.605(b) for use in infant

18 formula only, lutein using approved organic

19 delivery ingredients, CAS No. 12740-2, that

20 vote was 3 yes, 4 no.

21 If we could go to the next slide,

22 we could summarize public comments. The
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1 other, one other thing I would mention here,

2 that the petitioner did mention that there

3 were a couple of other materials like pectin

4 and lycopene non-bleached that were produced 

5 in a similar fashion, and that was one of the

6 basis why they felt that that product material

7 should be listed as a non-synthetic.

8 But because of the information

9 being confidential, the Board felt that we had

10 no choice but to vote it as a synthetic. If

11 we could go up one more, I think Michelle, or

12 do we not have that? Okay, never mind. I've

13 got it here. I'll just summarize.

14 Okay. Public comment summary. We

15 had seven comments that were specifically in

16 favor of listing lutein. We had eight

17 comments that were specifically mentioned

18 against the listing of lutein. There were

19 numerous comments against allowing synthetics

20 in general, 7,418 plus numerous additional

21 ones.

22 There were also several comments
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1 against additives, synthetic or otherwise,

2 allowed for use in infant formulas, asking

3 that we don't allow the over-fortification of

4 infant formula. A quick summary of those that

5 were in favor of listing on 205.605(b) is

6 there's enough new scientific data to support

7 the need during infancy, not only for eye

8 growth in development but also for neural

9 growth in development as well.

10 It's also within the last few

11 years that nutritional and medical research

12 has demonstrated positive effects of lutein

13 for adult and infant eye and neural health, a

14 similar quote. Lutein is found in human

15 breast milk and its antioxidant properties can

16 help protect infant's eyes from UV damage.

17 Cow's milk and soy-based formulas

18 contain minimal lutein unless it's fortified. 

19 Lutein cannot be synthesized by the bodies;

20 therefore, it is strictly from a dietary

21 origin.

22 Any synthetic added to the
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1 National List must be required by law, or

2 essential for the handling of organically3 produced agricultural products, and

4 commercially unavailable in natural or organic

5 forms.

6 NOSB was also urged to consider

7 the essentiality, and this is kind of more of

8 a general for the different components or

9 materials that we're looking at today. But

10 one of the general comments was the NOSB is

11 urged to consider essentiality of nutrient12 based, of the nutrient based on its critical

13 function to infant, toddler or human

14 development.

15 The decision to call a nutrient

16 non-essential, because it's not specifically

17 listed as essential by FDA in the Code of

18 Federal Regulations, ignores valid and

19 published scientific information by respected

20 organizations.

21 A summary of those that are

22 opposed to the listing of lutein, were opposed
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1 to the construction of organic infant formula

2 from synthetic materials. Concerns over

3 fortification of infant formulas that may

4 place undue burdens or metabolic and other

5 physiologic functions on the infant.

6 Breast feeding is by far the

7 better approach to overall infant health

8 development, when compared to the alternative

9 choice of using formula. It's not mandatory,

10 according to the FDA infant formula

11 regulations. It's not permitted in the EU,

12 either in conventional nor in organic infant

13 formula.

14 Still unproven to be beneficial to

15 infant health or development. It's not

16 consistent with organic principles. It's not

17 essential because scientific evidence of its

18 essentiality has not yet been proven. That

19 sums it up, John.

20 MR. FOSTER: Thank you for that

21 summary. Any questions on lutein for -- yes,

22 Jean?
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1 MS. RICHARDSON: I'm just seeking

2 clarification on two issues. One, and perhaps

3 this one should go to our experts for

4 clarification, as to whether this should be

5 classified as synthetic or non-synthetic, and

6 secondly, is the primary purpose as an

7 antioxidant preservative or for the health

8 benefits on the eye?

9 DR. ANDERSON: The purpose that

10 infant formula manufacturers add lutein to

11 infant formula is as a mixture of

12 antioxidants, purported to protect tissues in

13 infants, and then the second part of your

14 question please?

15 MS. RICHARDSON: Synthetic or non16 synthetic?

17 DR. ANDERSON: Oh. That is not a

18 question I can answer.

19 MR. FOSTER: Additional questions? 

20 Harold?

21 MR. AUSTIN: I have a question

22 also for our experts. One of the comments in
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1 public comment that was made to us that we'd

2 like some clarification on is Question No. 8. 

3 A formula manufacturer commented that the CFR

4 107.100, the list of requirements for infant

5 formula, has not been updated since 1985.

6 Is this correct, and if it is, is

7 there any plans to look at any additions to

8 that list in the future?

9 DR. ANDERSON: The requirements in

10 21 C.F.R. 107.100 were indeed promulgated in

11 1985. They have not been updated since that

12 time. Those values, those substances and

13 those values came about as a result of

14 recommendations from the American Academy of

15 Pediatrics to the agency.

16 As far as updating, it has been 30

17 years or maybe even more. The decision to

18 update will rely on agency priorities and on

19 having the available resources to do so.

20 DR. BHATIA: The Committee on

21 Nutrition is concerned about this old

22 document, because some of them are made on
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1 presumption, and some of them are made on data

2 that we now have. However, this is not a

3 simple agency matter. This is a Congressional

4 mandate. 

5 So for us, we've started the

6 process of asking the question, but it has to

7 bring all the agencies together and then go

8 through Congress before that Act can be

9 changed.

10 MR. FOSTER: Can we go for two

11 more questions here. We've got to keep

12 moving, and for that I see Jay and Tracy, and

13 with the reminder that if we can get through

14 all these materials, we can circle back to

15 some of these other questions. But Jay and

16 Tracy, and then we'll move on to lycopene.

17 MR. FELDMAN: Thank you, John. 

18 Thanks again for being here. As you know,

19 this is not a technical board in the sense of

20 evaluating scientific criteria, and therefore

21 the law that we're operating under is very

22 clear, that we should rely on requirements in
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1 other laws, in terms of added materials, added

2 nutrients and so forth.

3 So the use of your word

4 "purportedly" in the context of manufactured

5 claims caught my attention. I'm wondering

6 about the process that we should rely on, this

7 body should rely on, in terms of making these

8 determinations, and whether we should not ask,

9 is it unreasonable for a body like this to

10 request a manufacturer to go back to the FDA,

11 or some other body, so that they can get the 

12 classification that would meet our

13 requirements standard, or is that an

14 unreasonable request, and you know,

15 impractical request or not practical request?

16 DR. ANDERSON: Perhaps this would

17 be a good time to say a few words about FDA's

18 regulation of infant formulas. FDA regulates

19 infant formulas as foods, and there are two

20 primary offices that are involved in the

21 regulation: The Office of Nutrition, Labeling

22 and Dietary Supplements, which is my office,
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1 regulates the infant formula finished product.

2 The Office of Food Additive Safety

3 regulates the ingredients that are used in

4 infant formulas. The two offices work very

5 closely together on this, whenever there's any

6 question or any issue involved with infant

7 formula or new ingredients in infant formulas.

8 Infant formula manufacturers are

9 required to make a pre-market notification to

10 FDA whenever they propose to market a new

11 infant formula or make a change in a

12 formulation or for one of their existing

13 products.

14 Addition of a new ingredient or a

15 modified ingredient would require a pre-market

16 notification, and in our review of an infant

17 formulation notification, we would want to be

18 assured that the, of the scientific basis of

19 safety of the new ingredients for use in

20 infant formula.

21 What FDA has to regulate

22 ingredients on is their safety. Efficacy is
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1 a consideration for drugs. It is not a

2 consideration for food ingredients, for the

3 safety of food ingredients. It is a

4 consideration, efficacy is a consideration for

5 claims on products, but not for their safety

6 of use in the products. 

7 We consult with the Office of Food

8 Additive Safety regarding any questions about

9 the safety of use of a new ingredient in

10 infant formula, and we always encourage infant

11 formula manufacturers to work with the Office

12 of Food Additive Safety to resolve any

13 questions about the safety for use in infant

14 formula, before they submit a pre-market

15 notification to us.

16 MR. FOSTER: Thank you. Tracy. MS.

17 FAVRE: I'm going to apologize in advance for

18 my question, because I realize it's going to

19 put you on the spot. But Dr. Bhatia, can you

20 tell me if in your opinion the benefits of

21 these added nutrients outweigh the potential

22 concerns about the fact that we're looking at
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1 synthetic additives?

2 DR. BHATIA: I cannot, because

3 what has been shown so far, specifically in

4 the nutrient we're talking in question is yes,

5 breast milk has it; formulas don't. What has

6 been shown so far is if added in formula, you

7 have ocular growth. The functional claims that

8 people are claiming still have not been shown

9 in long-term studies.

10 So addition of a new nutrient to

11 make it similar to human milk has been -- I

12 think for 30 years we've been trying to do

13 that. But to prove a long-term effect, you

14 need more studies. There are studies showing

15 so far short-term safe, but not enough to say

16 this has to be put into infant formula at this

17 current time.

18 MS. FAVRE: Thank you.

19 MR. FOSTER: Thanks. All right. 

20 Mindful we're halfway through our time and a

21 third of the way through the agenda, I have to

22 hold on to additional questions on lutein, and
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1 move on to lycopene. Lisa.

2 MS. BRINES: Thanks, John. The

3 petition for lycopene was received on

4 September 19th, 2011, and was submitted by the

5 International Formula Council. The petition

6 requests the inclusion of lycopene at Section

7 205.605 of the National List, for use as an

8 ingredient in infant formula.

9 Lycopene does not appear elsewhere

10 on the National List, but there was a previous

11 petition in 2007 for lycopene juice, and that

12 was for use as a color. This petition for

13 lycopene is for the synthetic form. 

14 In support of the review of the

15 petition, the Subcommittee had requested the

16 development of a technical report, and both

17 that technical report and the petition for

18 lycopene were available to the public in

19 advance of the opening of the public comment

20 period for this meeting, and again the

21 petitioner is available for in-person public

22 comment later this morning. Thanks.
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1 MR. FOSTER: Thank you very much,

2 Lisa. Nick, you had the pleasure of dealing

3 with this through the term. Would you take it

4 from here?

5 MR. MARAVELL: Okay. Thank you,

6 John. The petition for lycopene in the

7 synthetic form is primarily -- the argument

8 for it is primarily based on the fact that

9 natural sources of lycopene would come from

10 food substances, for example, tomato, and it

11 may contain proteins which could potentially

12 induce an allergic response.

13 This is sort of extended from the

14 argument that some people are allergic to

15 tomatoes. We could not find any specific

16 substantiation of that direct connection, and

17 the TR, the Technical Review, hypothesized

18 that any response, allergic response to

19 tomatoes is more than likely related to the

20 acidity rather than the make-up of the

21 proteins in lycopene.

22 In checking with the other
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1 standards, European, Canadian, Japanese,

2 synthetic lycopene is not permitted in infant

3 formula, and it does not appear that lycopene

4 is a required addition to infant formula. The

5 public comments fell pretty much along the

6 same lines as for ascorbyl palmitate and beta

7 carotene, with the consumer and interest

8 group, public interest group community

9 questioning the need for the addition of

10 synthetics into infant formula.

11 And there were some industry

12 groups that supported the addition of

13 synthetic lycopene because it is a powerful

14 antioxidant, and could have potential

15 benefits.

16 I don't think that we're disputing

17 that; we're simply disputing the fact that it

18 does not need to come from a synthetic source,

19 and therefore the committee voted to declare

20 it a synthetic, it was petitioned as a

21 synthetic, and to not add it to the National

22 List. Both votes were unanimous. There were
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1 two absent at that deliberation. 

2 MR. FOSTER: Thank you, Nick. 

3 Questions from the Board on lycopene? Jay.

4 MR. FELDMAN: I would just like to

5 ask the same question. I hate to be redundant

6 on this, but again, on the question of

7 required by FDA or any other body that we

8 should be aware of, that would deem this

9 material essential or essentially required to

10 be added to infant formula. Can you address

11 that?

12 DR. ANDERSON: Lycopene is not

13 included in the list of 29 required nutrients

14 for infant formulas. The FDA refers to an

15 authoritative scientific body in determining

16 what nutrients are essential for infants, in

17 this case, the Institute of Medicine of the

18 National Academy of Sciences.

19 FDA regards Vitamin A as

20 essential, and would also recognize that beta

21 carotene, as a source pro-vitamin for Vitamin

22 A, could be considered a vitamin. Lutein and
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1 lycopene are not pro-Vitamin A sources, and we

2 do not consider them essential.

3 MR. FOSTER: Thank you. One more?

4 All right. Then with no more questions, let's

5 move on to L-carnitine. Lisa.

6 MS. BRINES: Thanks, John. The

7 petition for L-carnitine was received on

8 November 10th, 2011, and was submitted by the

9 International Formula Council. The petition

10 requests the inclusion of L-carnitine at

11 Section 205.605(b) of the National List for

12 uses as an ingredient in infant formula.

13 In support of its review of this

14 petition, this handling Subcommittee did

15 request the development of a third party

16 technical report, and both the report and the

17 petition were available to the public on the

18 NOP website in advance of the opening of the

19 public comment period for this meeting, and

20 again the petitioner will be available later

21 this morning for in-person public comment. 

22 Thanks.
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1 MR. FOSTER: Thank you, Lisa. 

2 Zea, you were the lead on L-carnitine. Thank

3 you.

4 MS. SONNABEND: Thank you. L5 carnitine is a compound that's synthesized in

6 the body from the amino acids lysine and

7 methionine. These amino acids are abundant in

8 foods, such as beans avocados and red meat. 

9 The synthetic form has been

10 petitioned for use in infant formula because

11 soy-based formulas contain very low levels of

12 carnitine, and infants are less able to

13 synthesize carnitine for themselves. Cow's

14 milk formulas can also be low in carnitine

15 because the milk is diluted in the formula. 

16 Unlike some other ingredients, and

17 one we'll talk about in a minute, L18 methionine, carnitine is not required under

19 the FDA 21 C.F.R. sections that refer to

20 infant formula that we could find.

21 We have been led to understand

22 that it is required in the EU, and we're not
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1 sure why L-methionine would be required and L2 carnitine not, which we'll ask our experts

3 after the L-methionine presentation, I would

4 imagine.

5 But in any event, it appeared to

6 us that it would be feasible to make carnitine

7 or extract it from non-synthetic sources,

8 although this is not commercially done at this

9 time. For these reasons, the Handling

10 Subcommittee is not recommending to add

11 synthetic L-carnitine to the National List.

12 MR. FOSTER: Thank you, Zea. Any

13 questions on L-carnitine at the moment? My

14 guess is we'll have a question on both L15 carnitine and L-methionine in a few minutes. 

16 All right. Let's move on then to L17 methionine. Lisa.

18 MS. BRINES: Thanks, John. The

19 petition for L-methionine was received on

20 October 26, 2011, and was submitted by the

21 International Formula Council. The petition

22 requests the inclusion of L-methionine at
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1 Section 205.605(b) of the National List for

2 fortification of infant formula, which is

3 based on isolated soy protein.

4 In support of its review, the

5 Handling Subcommittee did request the

6 development of a third party technical report,

7 and that report and the petition were

8 available to the public on the NOP website in

9 advance of the opening of the public comment

10 period. Thanks.

11 MR. FOSTER: Thank you, Lisa. 

12 Tracy, you were lead on this. Take it from

13 here.

14 MS. FAVRE: Yes. L-methionine is

15 an essential amino acid that's required for

16 proper human development, and it has been

17 petitioned for the use in soy-based formulas,

18 because the protein content specifically in

19 soy-based formula is not sufficient without

20 the addition of the L-methionine. 

21 We had lots and lots of

22 conversations about this on the Subcommittee. 
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1 Just like most of the formula additions that

2 we've been talking about this morning, there

3 were pretty strong arguments on both sides in

4 the public comments, primarily from the same

5 sorts of groups, whether it was the consumer,

6 general consumers versus the manufacturers.

7 In the discussion about the

8 inclusion of synthetic L-methionine, I

9 personally was troubled, because the

10 manufacturing process can be fairly toxic. 

11 But we do have a significant deficiency, in

12 fact essentially after some clarification

13 during some expert discussion during

14 subcommittee meetings, there essentially would

15 be no soy-based formula with the addition of

16 L-methionine, because of the minimum protein

17 requirements specified for infant formula.

18 So as a result, we did vote

19 unanimously, excuse me. There was 6 votes

20 yes, 1 absent for the classification motion

21 for synthetic L-methionine on 205.605(b), and

22 on the listing motion, there was a 6 yes, 1
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1 absent vote on the agreement to include L2 methionine on 205.605(b).

3 During some subcommittee

4 discussions prior to the meeting here this

5 week, the original motion was for use in

6 infant formula made with isolated soy-based

7 protein, and we've elected to strike the word

8 "isolated" on the soy-based protein because of

9 concerns about the manufacturing process on

10 isolated soy-based protein.

11 Again, we're hoping our two

12 experts here today can provide us some

13 clarification specifically about L-methionine

14 and the protein requirements, as well as

15 whether or not the isolated soy-based protein

16 is an issue. Thank you.

17 MR. FOSTER: Thank you, Tracy. It

18 sounds like we have a couple of questions for,

19 regarding both L-carnitine and L-methionine

20 that were put forward. So I had Zea and then

21 Tracy. If you want to encapsulate your

22 questions. Zea, you want to go first? Yes,
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1 for carnitine or methionine.

2 MS. SONNABEND: Well, I think I

3 posed the question, which is why is L4 methionine required by FDA and L-carnitine

5 not?

6 DR. ANDERSON: L-methionine is

7 recognized as an essential amino acid,

8 necessary for the growth and development of

9 infants. It is permitted for use in foods and

10 in infant formulas by FDA's food additive

11 regulations.

12 Carnitine, as you said, can be

13 synthesized from the amino acids L-methionine

14 and L-lysine. It is not as -- there's not as

15 much support for its essentiality in infant

16 nutrition as there is for methionine, and

17 given that it can be synthesized by the

18 infant, it has not been included as essential

19 for inclusion in infant formula.

20 DR. BHATIA: The essentiality of

21 L-methionine soy infant formulas was

22 demonstrated many, many years ago. Soy
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1 protein is not the same as common protein, and

2 protein has less L-methionine in it. So there

3 would be an L-methionine deficiency created if

4 you feed soy infant formulas without added

5 methionine.

6 In addition, if you look at soy

7 infant formula label, you will notice that the

8 total protein content per deciliter or per 100

9 calories in soy formulas are higher than

10 common formulas, to make up for the relative

11 inefficiency, if you will, of soy protein

12 formula.

13 Having said that, soy protein

14 isolate, I'm not a manufacturer and neither do

15 I have expertise in manufacturing, is the only

16 soy protein formula used in the United States

17 and in Europe. Plain soy protein is not.

18 Carnitine deficiency is relatively

19 rare. In 30 years of doing clinical

20 neonatology and nutrition, I've probably

21 referred four to five babies for carnitine

22 deficiency. So carnitine, as an essential
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1 nutrient for the general population of

2 infants, is actually the evidence is quite

3 low.

4 MR. FOSTER: Okay, thank you. 

5 Tracy, do you want to recapture your question,

6 or are you good?

7 (Off record comment.)

8 MR. FOSTER: Okay, okay. Mac and

9 then Jay, and then we should wrap it up, or

10 Zea, if you've got a follow-up.

11 MR. STONE: Do either of you all

12 have a sense of what percentage, I guess I'm

13 heading towards lactose intolerance, or what

14 percentage are soy-based versus cow milk based

15 infant formulas?

16 DR. BHATIA: The actual percent of

17 lactose, true lactose intolerance in the

18 general population is an estimate, because

19 self-reported. In all populations, it's

20 between about 10 to 12 percent perceived.

21 In infants, it's less than five

22 percent, and that is true persistent lactose
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1 intolerance, which shows up at approximately

2 two years of age. The secondary lactose

3 intolerance that occurs in neonatal after,

4 say, acute diarrhea. 

5 So lactose, true lactose

6 deficiency, which is rare, then is one

7 indication for using soy infant formulas

8 because it's made of sucrose and not lactose. 

9 However, that was the only choice available

10 10-15 years ago.

11 Now we have other choices that

12 when used with limited lactose compared to

13 completely going to soy. Soy infant formulas

14 are not indicated in pre-term infants in the

15 first place. In the second place, in term

16 infants, currently the opinion is there are

17 only three indications for soy infant

18 formulas.

19 One, there's a metabolic disease,

20 galactosemia, because they cannot tolerate the

21 glucose-galactose and soy infant formula is

22 indicated for that. Two is secondary
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1 persistent lactose intolerance, and three is

2 a personal choice, because we have

3 vegetarianism, which make you who may choose

4 to have soy as a primary source, not cow milk.

5 This can become a concern for

6 nutrition because soy, otherwise for healthy

7 term infants is fine; but for subpopulations,

8 it is not fine.

9 DR. ANDERSON: With regard to the

10 amount of soy infant formula that is sold in

11 the United States, the latest figures that I

12 have seen are that about 10 to 12 percent of

13 infant formula sales are for soy infant

14 formulas.

15 DR. BHATIA: I need to add that in

16 Canada, it's less than two percent, England

17 is two percent, and in New Zealand, you have

18 to go to the pharmacist behind the counter to

19 ask for soy, for the same reasons I've

20 outlined, that there's no need to abuse soy

21 infant formulas in infancy.

22 After infancy, it is relatively
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1 data poor, and evidence rich that epidemiology

2 studies have not shown harmful effects. But

3 infancy, there are specific issues. Why use

4 soy when you have other formulas available?

5 MR. FOSTER: Thank you. Jay,

6 question, or Zea. Okay. Straight to the

7 question, if we could?

8 MR. FELDMAN: I'm actually working

9 off this sheet of questions or list of

10 questions that were sent earlier, and I'm not

11 sure where there's a good place. This seems

12 to be the best place to sort of raise this,

13 given what you've already said.

14 First, this distinction. I've

15 read your article, Dr. Bhatia, on use of soy

16 protein-based formulas, and just want to get

17 clarification on this distinction that's being

18 made, I believe to the committee and the Board

19 here, that there is a distinction between soy

20 protein isolate and soy concentrate, and that

21 in effect, there is -- there are different

22 issues that we would address in those
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1 different contexts.

2 Again, it would be helpful as the

3 Question No. 9 indicates on this list, given

4 that we are putting essentially a

5 certification on a soy product, driving in

6 effect consumers toward that product based on

7 some assumption of its added value with that

8 certification, that organic certification,

9 presumably that will increase sales of that

10 product, or at least shift sales in that

11 direction.

12 I guess I'm looking, given your

13 work on this, looking to you to advise this

14 body on what questions ought to be answered,

15 may have not been answered in the past, and

16 should be answered in the future, regarding

17 the evaluation of the soy isolate and the

18 impact that that has as a derived material,

19 synthetically derived material, and its

20 safety-related and need related to infant

21 health.

22 You've already identified the pre-
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1 term infancy impacts there, but again, we're

2 looking at the broader picture, in terms of

3 soy isolate versus soy concentrate, and its

4 essentiality in the market.

5 DR. BHATIA: In my opinion

6 clinically, soy isolate should be the only

7 protein used in infant formulas. There is no

8 question that if you use intact soy, and you

9 chop it up into different pieces of it and

10 feed it to animal models that you have,

11 deleterious effects.

12 In the last 40 years in infant

13 formula and nutrition research, we have not

14 demonstrated any harmful effects of soy

15 isolate as it is produced and fed to infants

16 in the United States and Europe, using a soy

17 protein isolate.

18 The concerns have been the use and

19 abuse of soy for colic. It does not prevent

20 it. Use and abuse of soy for allergy, it is

21 not a formula to prevent allergy. The concern

22 about premature reproductive issues. Those
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1 data are extremely weak in the human model,

2 and I have participated in two NIEHS panels

3 and have come to the same conclusion.

4 In human nutrition, soy infant

5 formulas, as fed in the United States, there's

6 minimal concern about the issue on

7 reproductive health. So for those reasons,

8 there's no other issue for soy except for the

9 three indications I've told you.

10 I'm very happy that since we, the

11 Committee on Nutrition, took over and started

12 espousing the lack of benefit of soy in the

13 routine infant, that the soy formula has

14 dropped from 20 percent ten years ago to 12

15 percent that Dr. Anderson just mentioned.

16 So there is no need for routine

17 indication of soy infant formula in term

18 healthy infants, unless it is a personal

19 choice, or a metabolic disease like I outlined

20 before.

21 MR. FOSTER: All right. Let's

22 bring this back to methionine, away from, if
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1 we could. Zea.

2 MS. SONNABEND: Okay. We would

3 like to hear the policy of the American

4 Academy of Pediatricians on breast feeding and

5 the use of formula.

6 DR. BHATIA: The Committee on

7 Nutrition, as well as the Section on

8 Breastfeeding both agree that the period of

9 exclusive breast feeding is about six months. 

10 The world bodies come across and tell you

11 between four and six months may be the actual

12 window. We don't need to argue. That's about

13 six months.

14 That's a WHO recommendation,

15 ESAPAGAN recommendation and AAP

16 recommendation. So that's exclusive breast

17 feeding. However, the fact of life is

18 exclusive breast feeding up to six months in

19 the United States is not to the point of the

20 Surgeon General's request that we have

21 exclusivity. We are pushing it, but it's not

22 there.
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1 Is there evidence to show that if

2 you feed for 4.1 months, it's less advantages

3 than feeding for 4.9 months? No. Is there

4 evidence to show they feed less than four

5 months? Yes. So there is a dose response

6 relationship. 

7 So we feel that between four and

8 six months or about six months will the

9 optimal exclusivity for breast feeding. 

10 Infant formula is a safe alternative, if you

11 choose not to breast feed or cannot breast

12 feed or should not breast feed, and they have

13 a safety record of their own for the last

14 decades.

15 MR. FOSTER: Thank you. We have

16 some more time to wrap back, circle back

17 around on carnitine and methionine at the end. 

18 We can do that, but in the meantime, we'd like

19 to move on to the topic of nucleotides, and I

20 asked Zea to present this, although I did some

21 of the work on this also. Zea. I'm sorry,

22 Lisa, would you --
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1 MS. BRINES: Did we skip taurine,

2 John?

3 MR. FOSTER: Oh, okay. It's

4 different in the order I have, but sure,

5 taurine we can do first.

6 MS. BRINES: Okay. We'll do

7 taurine. I've got that in front of me.

8 MR. FOSTER: Alphabetical order? 

9 MS. BRINES: Thanks, John. The

10 petition for taurine was received on September

11 14, 2011, and was submitted by the

12 International Formula Council. The petition

13 requests the inclusion of taurine at Section

14 205.605(b) of the National List as an

15 ingredient for use in infant formula.

16 In support of its review, the

17 Handling Subcommittee did request the

18 development of a third party Technical Report,

19 and both the report and the petition were

20 available to the public on the NOP website in

21 advance of the opening of the public comment

22 period for this substance. Thanks.
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1 MR. FOSTER: Thank you, and on

2 taurine, Jean, you were lead on this. Would

3 you take it? Thank you.

4 MS. RICHARDSON: So taurine is

5 neither a vitamin nor a mineral. Although

6 it's referred to as an amino acid, it's

7 actually more accurately classified as a B8 amino sulfone. It's found in animal protein,

9 such as seafood, beef, chicken, and it's

10 nearly absent in vegetarian foods.

11 While taurine could be produced

12 non-synthetically, it's not commercially

13 available. But it is, in any event, the

14 synthetic form, which has been petitioned for

15 use in infant formula, and its use is to

16 assist in subfat, subpar fat absorption in

17 infants, because insufficient taurine would

18 result in poor fat absorption, and fat

19 absorption is extremely important in infants.

20 There is, however, conflicting

21 scientific opinion regards the necessity of

22 taurine in either human nutrition, and
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1 especially for infants. Taurine is not an

2 FDA-required nutrient in baby formula,

3 although it's often added to both conventional

4 soy and milk-based formula.

5 Taurine is not listed on the IFOAM

6 list, nor is it required in European infant

7 formula, and it does not appear on the JAS

8 list in Japan. It doesn't appear to be listed

9 as GRAS. Taurine as petitioned is intended as

10 a dietary supplement, and it does not appear

11 to be essential, and that's certainly a

12 question that the Subcommittee has for our

13 experts, is the essentiality.

14 So the Handling Committee

15 therefore is not recommending the addition of

16 taurine to the National List at this time. 

17 The vote on the Subcommittee, which is here,

18 was 4 to 0 not to list it. Three persons were

19 absent. 

20 The public comments were the same

21 as those that have been expressed by other

22 Board members for those other products,
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1 inasmuch as there was lack of support from

2 consumers, and there was strong support from

3 Infant Formula Council and the related

4 manufacturing organizations.

5 So perhaps we could ask for first

6 clarification on the necessity of taurine.

7 DR. ANDERSON: Scientific evidence

8 doesn't indicate that taurine is essential in

9 the diets of human infants. The National

10 Academy of Sciences, the Institute of

11 Medicine, National Academy of Sciences,

12 doesn't recognize it as an essential nutrient

13 for humans.

14 It is not on the list of required

15 nutrients for infant formula. However, it has

16 been used as an optional ingredient.

17 MR. FOSTER: Thank you.

18 DR. BHATIA: There have been some

19 classical studies done in the late 80's to

20 show that if you don't have taurine, there are

21 effects, short-term effects of the taurine

22 status, if you will, and there are some new
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1 development concerns in a subset of infants,

2 especially low birth weight infants.

3 But having said that, I concur

4 with what Dr. Anderson is saying. Strictly

5 speaking, the answer is no. Relatively

6 speaking, the answer is yes.

7 MR. FOSTER: Thank you. 

8 DR. ANDERSON: And just one -- can

9 I make one more comment?

10 MR. FOSTER: Please.

11 DR. ANDERSON: We are really

12 concentrating this morning on infant formulas

13 for healthy term infants. We aren't

14 concentrating on the use of formulas for pre15 term infants or infants with special medical

16 problems.

17 MR. FOSTER: Thank you for

18 clarifying and reminding us of this. 

19 Additional questions on taurine from the

20 floor? 

21 (No response.)

22 MR. FOSTER: Thanks. Then let's
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1 move on, then, to nucleotides. Lisa.

2 MS. BRINES: Thanks, John. The

3 petition for nucleotides was received on

4 September 14th, 2011, and was submitted by the

5 International Formula Council. The petition

6 requests the inclusion of nucleotides isolated

7 from yeast, RNA, hydrolosate to Section

8 205.605 of the National List.

9 The petition identifies five

10 specific nucleotides for addition to the

11 National List, including the sodium salts. In

12 support of the review of this petition, the

13 Handling Subcommittee requested the

14 development of a third party technical report.

15 That report was developed, and

16 both the petition and technical report were

17 available to the public on the NOP website in

18 advance of the opening of the public comment

19 period for this meeting. Thanks.

20 MR. FOSTER: Thank you, Lisa. 

21 Zea, would you take it away?

22 MS. SONNABEND: Nucleotides are
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1 compounds that are made in the body from amino

2 acids. The amino acids are abundant in whole

3 foods with protein.

4 Now in our recommendation, the TR

5 was not very clear on the manufacturing

6 process, and it did lead us to think that it

7 as a synthetic form of nucleotides being

8 petitioned.

9 We have since heard a number of

10 public comments that has convinced the

11 committee, at least, that the nucleotides

12 really are non-synthetic. They're derived

13 from yeast and the processing of them is

14 similar to other things that we list on the

15 National List as non-synthetic, and in fact

16 yeast extracts are already on the National

17 List as non-synthetic.

18 Nucleotides are not mandated to be

19 added to infant formulas under the sections

20 regarding infant formulas, and the Handling

21 Committee is recommending to add non-synthetic

22 nucleotides to the National List.
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1 But we are going to recommend

2 changing our motions and the classification

3 motion will not change. It's just the voting

4 may be quite different because we'll leave it

5 as synthetic.

6 But if that motion fails, that

7 they're synthetic, then we will be adding it

8 to 205.605(a) instead of 205.605(b). We also

9 want to change the annotation coming from the

10 committee and remove the last sentence, that

11 the nucleotides be allowed for non-infant

12 formula foods that are made with organic

13 ingredients.

14 MR. FOSTER: Thank you, Zea. 

15 Questions on nucleotides? Jay.

16 MR. FELDMAN: Yes. I have a

17 question for the committee. In looking at

18 this change, I guess the issue I saw in the TR

19 was around crystallization and that process

20 for extraction.

21 So the question is, is the

22 crystallization process, what is that exactly,
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1 and is that considered non-synthetic? Is that

2 what the change is coming from? I mean where

3 is this change in the classification from?

4 MS. SONNABEND: Public comment was

5 submitted by OMRI and by Rich Theuer,

6 regarding how they perceive the method of

7 extracting the nucleotides, and it would be

8 better if you could ask the public commenters

9 that.

10 MR. FOSTER: Okay, thank you. 

11 Additional question on nucleotides at this

12 time? 

13 (No response.)

14 MR. FOSTER: Well done. Thank you

15 again Zea for last minute changes especially. 

16 All right. Last item on the list is the

17 discussion on auxiliary or Other Ingredients.

18 Zea, you were the lead on this as

19 well. Thank you again for working on this. 

20 This took a fair amount of conference call

21 time and a lot of work in writing. So thank

22 you again for that.
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1 MS. SONNABEND: I'm going to pull

2 out my notes here for a second. Okay. This

3 was a long and complicated document, and we

4 know that you would all love to spend a few

5 hours talking about this today. But we don't

6 really have a few hours to talk about this

7 today, and so the committee will have to take

8 those few hours and more, maybe, after the

9 meeting ends.

10 So I'm just going to give some

11 very broad sweeps on, you know, what types of

12 comments we received and a few of the points

13 that were made, without getting into very much

14 detail.

15 This is a public comment summary

16 from our discussion document on the screen. 

17 We received comments from 17 people and

18 organizations on this subject, and here is the

19 list of them in no particular order, except

20 the order they were in when Michelle gave us

21 the compiled document. 

22 Now underpinning this whole thing
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1 is a lot of things that have to do with the

2 overall classification of materials and what

3 OFPA and the rule actually say, and how you

4 define terms such as ingredients, substances,

5 processing aids and the like.

6 We're not going to get into all of

7 that here, but I do just want to frame that

8 among the organic community represented here, 

9 we have two fairly distinct ways of looking at 

10 OFPA Interpretation 1, and I have borrowed

11 language from some of the public comments. 

12 There were many that mimicked each other, so

13 I've just selected one representative comment

14 from each interpretation, to provide you here.

15 OFPA Interpretation 1: All

16 ingredients of a product labeled organic must

17 either be organic or on the National List for

18 that purpose. There is nothing in OFPA that

19 justifies making the distinction between

20 Ingredients and Other Ingredients.

21 We support a fourth option. No

22 ingredient of any kind can be in food labeled
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1 organic unless it is on the National List. 

2 The fourth option that they're naming Option

3 D is very similar to Option C, which almost

4 always requires all ingredients to be on the

5 National List.

6 It's the only option that fully

7 complies with the law, and captures the

8 expectation of the consumer that all non9 organic ingredients in organic food will be on

10 the National List. Going on to say that the

11 National List headings in the regulations

12 205.605 and 205.606 specify the use of non13 agricultural substances and agricultural

14 products, respectively, referred to as

15 ingredients.

16 OFPA Interpretation 2, and I'm

17 sorry the type is a bit small, but it takes a

18 bit to explain it. OFPA sets out rigorous

19 criteria for evaluating substances for

20 inclusion on the National List.

21 However, it is clear that OFPA

22 never intended to require a separate listing
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1 of Other Ingredients, incidental additives on

2 the National List. Rather, OFPA clearly

3 states that Other Ingredients should be

4 evaluated as part and parcel of the

5 consideration of substances for inclusion on

6 the list.

7 In establishing the criteria for

8 what should be included on the National List

9 and how items on the National List should be

10 evaluated, OFPA uses the term "substance" to

11 describe these items. It does use terms like

12 single ingredient or even ingredient in

13 Sections 2118 or 2119, and does not state that

14 substances made with more than one ingredient

15 must be evaluated individually.

16 Indeed, Section 2119 LRI-2 makes

17 it clear that it was understood that

18 substances might contain multiple ingredients, 

19 where it says, and this is quoting from OFPA,

20 "Work with manufacturers of substances

21 considered for inclusion on the National List

22 to obtain a complete list of ingredients, and
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1 determine whether such substances contain

2 inert materials that are synthetically

3 produced."

4 This is not a loophole in the

5 standard that would allow for incidental

6 additives that are incompatible with organic

7 agriculture to be used; rather, it is a

8 mechanism to allow a substance to be

9 thoroughly evaluated through one petition and

10 evaluation process, rather than requiring

11 multiple petitions and reviews for each item

12 on the National List.

13 Okay. The second interpretation

14 is the one that most previous NOSBs and the

15 Department has generally been using, inputting

16 items on the National List, and Option 1 is

17 being insisted on by many members, some

18 members of the organic community.

19 I don't think until you bring in

20 like large teams of lawyers from either side

21 you're going to get a definitive answer to

22 these two different interpretations of what
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1 stands in our rule, which is somewhat vague in

2 its terminology to begin with. 

3 With all that in mind, we had a

4 fair number of commenters speaking up about

5 the options that we presented. We presented

6 three options, gave long lists of pros and

7 cons of each option, and I was actually a

8 little surprised that very few if any

9 commenters said that they thought Option A was

10 absolutely the best option. Kind of nobody

11 said that. 

12 Option A certainly is the easiest

13 and some would argue it's what we have been

14 doing so far, where these issues weren't fully

15 understood by NOSBs in the past. So if

16 something showed up with another ingredient,

17 it was adopted without much scrutiny in some

18 cases, or adopted with considerable scrutiny

19 in other cases, but adopted nonetheless.

20 I would say that the majority of

21 the commenters favored Option B, but almost

22 all of them had some concerns or additions or
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1 subtractions from Option B, and then there

2 were almost none that came out for Option C

3 straight out, but some who came out for this

4 Option D, which is really similar to C except

5 once the secondary, the disinfectants and

6 cleaning agents and things to be added.

7 Okay. The concerns of many

8 people. First of all, our proposal for the

9 database being maintained by the NOP. Many

10 people were concerned that to ask for a

11 database in association with an option. This

12 concern is very valid, because the NOP has

13 enough to do, and maybe keeping another

14 database and more stuff would be outside their

15 ability to do.

16 However, one very good suggestion,

17 I thought, was that because the permitted

18 substances list is coming out anyway, which is

19 an affected database, it could be

20 incorporated. The approvals of Other

21 Ingredients could be incorporated into the

22 permitted substances list, where there will
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1 already be some level of spreadsheet or

2 columns or some way to codify that when

3 something is added to that list, it could have

4 the Other Ingredients associated with it.

5 Another concern that many people

6 had is the commercial availability clause. 

7 People were -- this would be applying the

8 issue of commercial availability to everything

9 on the National List.

10 Commenters came in all over the

11 map about this. This is something that the

12 committee, the Handling Subcommittee will

13 definitely be taking under advisement and

14 considering.

15 One thing that is very clear from

16 even the people who are proponents of Option

17 B, is that probably in the course of Sunset,

18 some of the inconsistencies in the past

19 reviews of things that are already on the

20 National List have to be cleaned up.

21 So we know that while some things

22 like the enzyme review, for instance, had very
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1 long lists of all the Other Ingredients that

2 could possibly be in it, and the NOSB looked

3 at that and adopted the recommendation, there

4 are other things from the past.

5 One I can think of is the wax

6 materials, carnauba and wood resin that

7 although it was known there were Other

8 Ingredients, at the time no one knew what they

9 were, and we couldn't get disclosure or

10 cooperation from industry like we can today.

11 So they went on there with nothing

12 mentioned in Other Ingredients, which has

13 really had a strong detrimental effect on

14 keeping these products from being formulated

15 and used in organic food. So we have work to

16 do, and much of that work will happen in

17 Sunset. 

18 Okay. I think that OTA correctly

19 pointed out that along with a policy, we have

20 to develop a whole review procedure. We have

21 to look at what we already have clearly, and

22 that's why we put the spreadsheet that we did
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1 as an attachment to the recommendation, so you

2 can see where we started to try and compile

3 the past decisions.

4 But we have to look at what we

5 have, and then we have to develop some steps

6 for how we're going to move forward on this

7 under any scenario that we adopt. Those steps

8 might be somewhat similar to the inerts

9 proposal we gave, because after all, and I

10 joked about this in the college, they didn't

11 really get it, you want us to change the term 

12 "inerts" and "other ingredients," and then we

13 have these other other ingredients. 

14 Although my nickname for several

15 decades has been "Materials Girl," I think I'm

16 going to change it to "Other Ingredients

17 Girl," and we'll see how that flies.

18 But anyway, I want to thank all

19 the commenters for really giving some

20 thoughtful responses to what was really a very

21 complicated and detailed recommendation, and

22 we can assure you that we will be giving it
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1 our close attention in the future. Thank you.

2 MR. FOSTER: Thank you, Zea, for

3 that, and thanks again. That was a tremendous

4 amount of work on the part of the

5 Subcommittee, but you shouldered a large

6 portion of that. So thank you very, very much

7 for that.

8 We have, by my clock, we have 16

9 minutes before we're scheduled for a break. 

10 But if there's opportunities for discussion on

11 this last item or burning questions around any

12 of the other materials that we've looked at,

13 now would be the time to do that. Mac?

14 MR. STONE: I have two, but I

15 don't mind taking them one at a time. Where

16 are we going to bump into this confidential

17 business information aspect, as we dig into

18 incidental additives? If the definition of

19 incident means it doesn't have a technical or

20 functional effect on the food, then why is it

21 there?

22 MS. SONNABEND: Well, that last
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1 one, I can't answer. So you'll have to ask it

2 to Dr. Anderson. As far as the first one yes,

3 we are always bumping into confidential

4 business information. But beyond that, the

5 biggest problem I see with Option C or D is

6 that it's going to ask for petitions for all

7 these so-called Other Ingredients.

8 It's very, very unlikely that

9 there's enough incentive for every single

10 other ingredient to petition individually to

11 have it, you know, have themselves included. 

12 And so it's not a question as much of

13 confidentiality as disclosure.

14 We're not even going to find out

15 what those ingredients are, and that is a big,

16 big obstacle for adopting those options.

17 MR. FOSTER: I'll refrain from

18 asking if we need a COI policy on Other

19 Ingredients. I won't do that. 

20 MS. SONNABEND: And partially in

21 answer to that question also, it's on our work

22 plan for the Materials Committee to revise the
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1 COI policy that we already have or CBI, not

2 COI, Confidential Business Information. It's

3 something that I am committed to work on

4 between now and the next meeting.

5 MS. SONNABEND: Thank you, Zea. 

6 Additional questions. Jay.

7 MR. FELDMAN: This is somewhat

8 related, because later, I think as we

9 discussed, the whole concept of soy formula,

10 there's one other element I wanted to bring to

11 the discussion, besides the issue of whether

12 we have adequately reviewed the implications

13 of the synthetic nature of soy isolate.

14 I direct this attention, this

15 question to Dr. Bhatia, about the estrogenic

16 properties of soy, and whether he or you

17 believe that there are issues that the

18 community should be concerned about in that

19 regard?

20 DR. BHATIA: The estrogenic

21 effects have been shown if you chop up soy

22 protein into individual components like
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1 dianisidine and genistein, and feed it in

2 higher quantities in animal models.

3 The estrogenic reports have been

4 reported in case reports and from Puerto Rico,

5 where there has been recall after many, many

6 years, to see if the infants were fed soy

7 formula or not.

8 The estrogenic effects are also

9 based on a JAMA article, which recalled a

10 recall of 30 years later about a, and don't

11 quote me on the actual hours, 30 years later

12 about a probable three to four hour increase

13 in menstrual period, and that was indicated in

14 the statistical analysis.

15 And it was that clinically

16 relevant, even the authors said, to take that

17 in advisement. So basically the extensive

18 exhaustive review that has taken place through

19 the NIEHS times two, has really not shown

20 that in human infants that estrogenic as we

21 know it right now, while feeding soy isolate

22 protein formulas manufactured in the United
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1 States, has any adverse effects.

2 So there's no, as far as I

3 concerned, there's no safety concerns on

4 estrogen in the human model as we know it.

5 MR. FOSTER: And you're saying

6 that's from real world data or clinical data

7 that you've reviewed?

8 DR. BHATIA: Yes sir.

9 MR. FOSTER: Thank you. 

10 Additional question? I have one kind of

11 following that, but I'll wait until the other

12 people have a chance. Okay. So someone help

13 me, correct me if I'm wrong here, if it's soy,

14 is soy protein isolate? Is that considered --

15 have we defined that as synthetic, and if it's

16 not, then doesn't it need to be organic, if

17 it's in an organic product? Help me out here. 

18 This is not my area of expertise clearly. 

19 DR. ANDERSON: Soy protein isolate

20 has not been approved by the full Board as

21 synthetic or non-synthetic. It was petitioned

22 as a crop input a long time ago, and as a crop
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1 input, it as determined to be synthetic by the

2 Crops Committee. 

3 But they got bogged down in the

4 classification and materials issues, so it

5 never came to the full Board and they decided

6 to wait for the Classification and Materials

7 document.

8 Soy protein isolate in infant

9 formula or in food, processed food. If it is

10 organic soy, then it has not been hexane11 extracted. But there's no like ruling on

12 processed food that a food is synthetic or not

13 synthetic.

14 MR. FOSTER: Okay. That helps me,

15 thank you. Other questions for any of the

16 agenda items. With ten minutes to go, really?

17 With that then, I would thank you, Doctors,

18 for being here. It's been very, very helpful.

19 I also want to really thank --

20 the agenda for the Handling Subcommittee was

21 pretty aggressive this term, and I just, I

22 want to call out the program staff. Was very,
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1 very supportive, very, very helpful in working

2 through a lot of complicated issues.

3 I just, I want to say thank you

4 for that. It was -- it was definitely a team

5 effort, and I appreciate that very, very much,

6 all of the staff. So thank you for that. If

7 that, that's all I have. So Barry, if you

8 want to take that virtual gavel back, it's all

9 yours.

10 CHAIRMAN FLAMM: I think we can

11 take a 15 minute break now and be back at,

12 what is it, five minutes after the hour, and

13 then John, you'll continue with the public

14 comments for your --

15 MR. FOSTER: Thank you, yes.

16 (Whereupon, the above-entitled

17 matter went off the record at 9:51 a.m. and

18 resumed at 10:08 a.m.)

19 MR. FOSTER: If we can reassemble

20 here, get started please. I have to get one

21 of these gavels for my office, I think, at

22 work. Thank you for your attention. Thanks
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1 again to our guests this morning. We found

2 that we had some little conversations here in

3 the break, and the Board found that very, very

4 helpful. So we're very appreciative to have

5 you here.

6 I understand they will be here and

7 available through the proceedings, at least

8 through lunch. So I want to just mention that

9 for the Board members. All right, I'll stop. 

10 All right. We are moving into our

11 public comment period for the Handling agenda. 

12 We are six minutes ahead. Lovely to see that. 

13 I haven't counted the number, but we have oh,

14 I don't know, 15 or 18, something like that,

15 to work through.

16 I will follow the pattern we have

17 started with, which is let, you know, two or

18 three people in line, let them know they're

19 coming up, and if anyone particularly

20 Michelle, I think you're the one who's advised

21 of last minute changes. If you could let me

22 know if there's any that I need to skip,
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1 please let me know.

2 Other than that, the first three I

3 have here are Beverly Rich, Charlotte Valaise

4 and Brook Anderson, in that order. So if you

5 could just make sure to state your name and

6 affiliation prior to your comments, that would

7 be very helpful. Thank you.

8 MS. RICH: Hello. My name is

9 Beverly Rich. I'm a member of the Cornucopia

10 Institute, but I'm testifying today as a

11 concerned consumer. My personal interest in

12 organic foods is as a health-conscious

13 citizen. I rely on the government to certify

14 that foods are organic and trust this means

15 they're natural and safe without any

16 artificial ingredients.

17 As a 38-year vegetarian, consuming

18 primarily organics, I read lists of

19 ingredients. However, I was not aware of

20 hidden ingredients, especially in organics. 

21 Thanks to the vigilance of the Cornucopia

22 Institute, I was informed that my trust in
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1 organic certification was misplaced.

2 I was deeply disturbed to find

3 that synthetic ingredients, including known

4 toxins, are being added to organic foods under

5 the guise of "Other Ingredients" or as

6 unlisted components of organic product

7 ingredients.

8 Though I am an attorney, I'm not

9 familiar with food safety laws, but in

10 preparing my testimony did some research. I

11 found as expected that federal law prohibits

12 synthetic additives to organics, though with

13 the exception of ingredients accepted by the

14 NOSB for inclusion on a National List.

15 The Organic Foods Production Act

16 of 1990, Section 2111, 7 U.S. Code 6510 is

17 clear in stating that anyone handling

18 agricultural products covered under the law

19 must not add any synthetic ingredient not

20 appearing on the National List during

21 processing or post-harvest handling.

22 I was shocked when I learned that 
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1 unapproved ingredients such as polysorbate 80,

2 sodium benzoate, polyacrylamide and numerous

3 other synthetics, which I carefully avoid when

4 I am aware of them, are routinely added to

5 organic foods as components of the ingredients

6 on the National List.

7 I was even more appalled to learn

8 that toxic materials, such as hexane and

9 propylene glycol, are routinely used in the

10 processing of ingredients found in organic

11 foods. This is a clear violation of the law,

12 and a betrayal of the trust of American

13 consumers.

14 I am not an expert in food science

15 or food processing, nor do I wish to become

16 one. I want to be able to trust the organic

17 label. The organic foods law assures me that

18 each and every ingredient, no matter how

19 small, has been carefully vetted by the NOSB,

20 satisfies organic handling requirements, and

21 is safe for consumption.

22 Now I've learned that the NOSB and
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1 the USDA have ignored this important legal

2 requirement, that up to five percent of the

3 ingredients in organic foods may contain

4 unapproved synthetics, which could include

5 toxins and/or carcinogens and more with no

6 oversight.

7 Organic consumers like myself do

8 not want unapproved synthetics in their

9 organic foods, period. Frankly, I don't want

10 any synthetics, but the current law does not

11 seem to give me that choice. I'm not alone in

12 these sentiments. A survey completed in

13 August 2012 by over 1,400 customers of PCC

14 Natural Markets in Seattle, the largest

15 cooperative grocer in the country, confirms

16 such consumer preferences.

17 PCC concluded from their survey

18 that their customers strongly prefer that

19 anything added to their food be from natural

20 sources, not synthetic, and that many, if not

21 most of them, prefer that nothing at all be

22 added to whole organic foods.
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1 For instance, 90 percent of

2 customers would not purchase foods with Omega3 3's made with synthetic additives or agents,

4 including hexanes, glucose, syrups, solids and

5 modified starch.

6 The inclusion of synthetic

7 preservatives, sweeteners and other unapproved

8 ingredients in organic foods constitutes a

9 massive industry-wide violation of the organic

10 law. It needs to be corrected.

11 Solution, simple. Follow the law. 

12 Respect consumer preferences and reasonable

13 expectations. Non-organic and non-agriculture

14 ingredients and processing aids used during

15 organic handling must appear on the National

16 List.

17 Please, don't force us to return

18 to the days, prior to the adoption of organic

19 standards, where consumers had to grow their

20 own food or buy direct from trusted farmers,

21 to ensure a supply of natural and safe food. 

22 Thank you for the opportunity to comment.
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1 MR. FOSTER: Nicely timed. Quick,

2 quick. Is there a question from the Board?

3 MS. RICH: My apology. This is my

4 first time testifying. 

5 MR. FOSTER: No problem, no

6 worries. Question? All right. Thank you for

7 your time. 

8 MS. RICH: Thank you.

9 MR. FOSTER: Next up, we have

10 Charlotte Vallaeys. Again, Brook Anderson on

11 deck.

12 MS. VALLAEYS: Good morning. My

13 name is Charlotte Vallaeys. I'm the Director

14 of Farm and Food Policy at the Cornucopia

15 Institute.

16 I have a Master's degree in

17 Nutrition Science and Policy from Tufts

18 University. I also have a Master's degree

19 from Harvard, where I studied Social and

20 Environmental Ethics from the Harvard Divinity

21 School.

22 I'd like to thank all of you for
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1 your hard work, with a special thanks to

2 Barry. Almost five years ago was my first

3 time attending an NOSB meeting. It was also

4 Barry's first meeting. I will miss you very

5 much, Barry, and I know a lot of others in the

6 organic community will as well.

7 I'd like to thank the Handling

8 Subcommittee for your very thorough work on

9 these petitions, and especially for inviting

10 experts in infant nutrition to weigh on these

11 very important questions.

12 We agree with the committee's

13 recommendation to reject taurine, lycopene and

14 lutein. They are produced in ways that are

15 legally incompatible with organic handling,

16 involving neurotoxic synthetic solvents. They

17 are not essential.

18 Experts agree that the scientific

19 evidence does not show the claimed benefits

20 exist. It's important to note also that the

21 European Union does not even allow lutein and

22 lycopene in any infant formula, including
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1 conventional. They are prohibited by all

2 other international organic standards.

3 Any claims of safety are based on

4 their GRAS status, generally recognized as

5 safe with the FDA. GRAS status relies

6 entirely on safety testing submitted by the

7 petitioner.

8 No independent or long-term safety

9 tests are required, and we know that post10 market surveillance by the formula

11 manufacturers is woefully inadequate.

12 This system has been widely

13 criticized as inadequate to protect public

14 health, including by the Governmental

15 Accountability Office, and we urge the NOSB to

16 uphold our higher organic standards.

17 We'd like to thank the Handling

18 Subcommittee also for your very thorough work

19 on the petitions for beta carotene and

20 ascorbyl palmitate, which were petitioned for

21 use as preservatives, and we support the

22 unanimous decision to reject.
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1 We also appreciate the

2 clarification from the two experts that these

3 are in fact preservatives. There is a

4 petition material that presents us with a bit

5 of a dilemma, L-methionine. It appears to be

6 required in soy-based formula only. If it is

7 not added, infants on soy formula would not

8 grow and develop properly.

9 Currently, the only sources that

10 appear commercially available are synthetic. 

11 The TR states that L-methionine's production

12 includes material such as acryline and EPA

13 hazardous air pollutants, and hydrogen

14 cyanide, described by the CDC as a systemic

15 chemical asphyxiant and a chemical warfare

16 agent.

17 So it is essential, because soy18 based infant formula is such an inherently

19 inadequate unhealthy food for human infants,

20 that it requires the addition of synthetic

21 macronutrients, just to keep the infants

22 alive. 
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1 But production involves synthetic

2 and polluting substances, and is therefore

3 incompatible with organic handling. So let me

4 ask you a question. At what point is a food

5 no longer a food, but a chemical substitute

6 for food, and do chemical substitutes for food

7 deserve the organic label?

8 In the European market, organic

9 soy-based formula does not exist. Where will

10 we draw the line? When the caregiver of an

11 infant sees the organic label on a soy-based

12 formula, their assumption is great; somebody

13 figured out how to make an organic soy

14 formula, with organic and natural ingredients.

15 Approving any additional

16 synthetics for formula would be a huge blow to

17 consumer trust in the organic label. Thank

18 you.

19 MR. FOSTER: Thank you. 

20 Questions. Calvin.

21 MR. WALKER: Thank you, John. My

22 question is what would be your views, as it
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1 relates to consumers' belief or support for

2 synthetics in infant formulas?

3 MS. VALLAEYS: I think in public

4 comments, the consumers have voiced their

5 opinion on this very clearly, and thousands

6 have commented that they do not think that

7 synthetics belong in organic products.

8 That includes organic infant

9 formula. I do think that when a mother or a

10 caregiver for an infant who needs formula sees

11 the organic label on a product, on that

12 formula, that they do think it's organic. 

13 They don't know that it contains the exact

14 same synthetics that are in the conventional,

15 that it is essentially the same in that

16 regard.

17 I think that that is very

18 misleading, and especially for the synthetic,

19 the two synthetic preservatives. I'd like to

20 point out that the natural label is heavily

21 criticized, of course, in the organic

22 community, because it is self-defined and it's
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1 so restrictive. 

2 There's yet one of the criteria

3 for the natural label that the industry can

4 agree on is no synthetic preservatives, right. 

5 So imagine the consumer confusion when it

6 becomes clear to them that an organic product

7 has synthetic preservatives. It wouldn't even

8 qualify for the industry's own natural label.

9 That is going to be a huge blow to

10 again consumer trust in the organic label,

11 that it contains natural and organic

12 ingredients.

13 MR. FOSTER: Jay.

14 MR. FELDMAN: Thank you, John. Hi

15 Charlotte. Can you walk us through the

16 practical effect of a decision to not allow

17 methionine?

18 What impact would that have on

19 what percentage of people that are now relying

20 on soy formula? What are the alternatives to

21 that, and what impact would we have in the

22 marketplace?
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1 MS. VALLAEYS: It's important to

2 consider the expert advice we heard this

3 morning about the need for soy-based infant

4 formula, that it is -- in other countries,

5 rates of use are around two percent is what we

6 heard, that it is in fact not necessary for

7 colic.

8 Right now, it appears, from what I

9 understood, that that's kind of abused, that

10 if your infant has colic, you just immediately

11 grab the soy-based formula, really without

12 that being necessary. So at that point, I

13 think soy-based formula has to shift away from

14 being considered a food, and more of a medical

15 product.

16 Again in New Zealand, you have to

17 go to the pharmacist, is what we heard this

18 morning, because it is considered a medical

19 product more than a food. I think that that

20 is very appropriate.

21 MR. FOSTER: Charlotte, just I

22 want to kind of make sure we're talking about
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1 methionine. Jay, I know that your question --

2 MS. VALLAEYS: Right, right. But

3 the question --

4 MR. FOSTER: Just bring it back,

5 that's all. Just bring it back. 

6 MS. VALLAEYS: So if --

7 MR. FELDMAN: No, just so John

8 understands, excuse me, the impact. If we're

9 going to have soy on the market, the experts

10 seem to agree that it doesn't perform any

11 function, and it could be detrimental without

12 methionine, without that amino acid. That's

13 a missing piece.

14 So the implication is pretty

15 dramatic, you know, if the Board rejects

16 methionine. I understand that that would

17 undermine the market for soy in the U.S. And

18 correct me if I'm wrong on this, I just want

19 to make sure.

20 Now I'm not saying that the Board

21 shouldn't do that, and I had another question

22 about soy isolate and sort of your opinion on
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1 that.

2 But I want, I'd like to be clear

3 about what the impact of that decision is, and

4 whether there are alternatives, and you're

5 describing a discrete part of the market that

6 uses this for medical purposes, that might

7 need it for medical purposes, and that's how

8 you're describing that percentage of the

9 market.

10 MS. VALLAEYS: Right, because if

11 L-methionine is rejected, I do think soy-based

12 formula with the organic label would not be

13 possible. I mean I wouldn't want to see an

14 organic soy formula without L-methionine, that

15 infants are going to not grow and develop

16 properly. Nobody wants to see that.

17 But at the same time, what we also

18 don't want is to mislead consumers into

19 thinking that this is organic, yet it contains

20 this L-methionine that is synthetic, very

21 problematic in how it's produced.

22 So that is the dilemma, and I
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1 think that's a decision that needs to be made. 

2 But considering what we heard about the actual

3 need for soy-based formula for infants.

4 MR. FOSTER: Thank you. Harold.

5 MR. AUSTIN: Charlotte, thank you. 

6 I think listening to your presentation right

7 now just kind of helps to emphasize for all of

8 us the struggles that we have with some of the

9 decisions that we try to make up here, that

10 what is right and what isn't right.

11 In this particular situation, when

12 should a synthetic be allowed, and under what

13 circumstance. So I appreciate your

14 presentation. You're walking through the

15 explanation.

16 But I think it also helps to show

17 the difficulty and the degree of difficulty

18 that these decisions bring with them on all of

19 these materials, and I appreciate your

20 presentation, your clarity on what you just

21 brought forth to us. Thank you.

22 MR. FOSTER: Additional questions?
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1 (No response.)

2 MR. FOSTER: All right, thank you. 

3 Next up we have Brook Anderson, Eric Lien or

4 Lean on deck. Yes, Brook Anderson, Perrigo

5 Nutritionals.

6 MR. ANDERSON: My name is Brook

7 Anderson. I'm the Director of Product

8 Development at PBM Nutritionals. I've been

9 developing and making infant formula for 29

10 years, all in one location in Vermont. Breast

11 milk is best, but we offer the best

12 alternative available for parents who, for

13 whatever reason, choose not to breast feed.

14 While many ingredients are not

15 mandated by the FDA to be added to infant

16 formula, advances in nutritional sciences and

17 research obligate infant formula manufacturers

18 to identify and add new ingredients to infant

19 formula, in order to provide optimal,

20 wholesome and safe infant nutrition.

21 I'm going to talk about two

22 petition substances. Beta carotene is the
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1 first one. Beta carotene, which was discussed

2 earlier, is a source of Vitamin A and also a

3 vitamin-based antioxidant. Beta carotene is

4 a vitamin that should already be allowed in

5 the organic products under CFR 205.605. 

6 Beta carotene is added to the PBM

7 infant formulas to mimic the levels of beta

8 carotene commonly found in breast milk. Beta

9 carotene was first added to U.S. infant

10 formula in 1933. It may also serve as an

11 antioxidant.

12 Beta carotene is also a vitamin13 based antioxidant that acts to scavenge

14 oxygen, and typically used in a combination

15 with other various substances including

16 tocopherols, ascorbyl palmitate, etcetera. As

17 an antioxidant, beta carotene serves to

18 protect fats, lipids and fat-soluble vitamins.

19 Because of its synergistic effect

20 among vitamin-based antioxidants, beta

21 carotene serves an essential role in the

22 keeping quality of infant formula.
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1 The only source of beta carotene

2 allowed for use in the U.S. is synthetic beta

3 carotene. Other potential sources that have

4 been mentioned previously, for example,

5 natural carotene or red palm oil are not

6 currently allowed or used in infant formula,

7 and would require GRAS notification safety

8 before their use.

9 Beta carotene is also listed as an

10 approved source of Vitamin A for direct

11 fortification for infant formula. US FDA,

12 CODEX, GB, China Regulations and allowed by

13 Health Canada.

14 Beta carotene is not toxic at high

15 levels unlike Vitamin A, and is a safe,

16 nutritional nutrient, an essential part of the

17 total Vitamin A content, required for optimal

18 infant nutrition or for meeting the total

19 Vitamin A content of the product.

20 The next petition substance is

21 ascorbyl palmitate. It is also known as AP. 

22 It's a vitamin-based antioxidant. Its primary
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1 use in infant formula as an antioxidant

2 required for nutrient stability. Its

3 secondary effect is for sensorial

4 preservation, a keeping quality of infant

5 formula. 

6 AP is GRAS-approved, is an

7 approved source of Vitamin C, and is an

8 antioxidant that is approved and accepted for

9 use in infant formula by various regulatory

10 agencies, including U.S. FDA, CODEX, the EU

11 Commission and is allowed in Health Canada for

12 use in infant formula.

13 AP is a unique antioxidant, as it

14 is a fat-soluble form of Vitamin C, and is

15 very effective in limiting oxidation reactions

16 in fats. Infant formula contains

17 approximately 28 percent fat, and contains

18 several fatty acids and fat-soluble vitamins

19 that are very susceptible to oxidation.

20 Preventing oxidation is thus

21 critical to the nutritional quality of the

22 product. Ascorbyl palmitate is but one
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1 essential substance of the total fat-soluble

2 antioxidant system used in infant formula.

3 AP is used in various combinations

4 with other vitamin substances, tocopherols,

5 beta carotene, etcetera. Due to the

6 synergistic effect that ascorbyl palmitate

7 exhibits on limiting oxidation, the essential

8 role that AP exhibits in various antioxidant

9 systems is well-documented.

10 Rosemary extract, which has been

11 suggested as an alternative to AP, is not

12 currently allowed in infant formula. Rosemary 

13 extract also has never been tested, is a

14 completely different chemical structure than

15 AP, and therefore is not an option or isn't

16 considered a viable alternative at this time.

17 Ascorbyl palmitate is thus an

18 essential part of the antioxidant system used

19 in infant formulas. Without AP, our infant

20 formula products would oxidize to the point of

21 not being suitable for consumption within

22 three to six months of manufacture. A shelf
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1 life of three to six months is not variable,

2 is not commercially viable. Sorry about that. 

3 I went over.

4 MR. FOSTER: Thank you

5 MR. ANDERSON: Last slide. I

6 thank the Board for letting me speak. 

7 MR. FOSTER: Thank you. Questions

8 or comments? Jean, Nick, Zea.

9 MS. RICHARDSON: Yes. My question

10 relates to the self life and the effect of

11 potential rancidity on the infant formula. So

12 if you don't add the beta carotene and the

13 ascorbyl palmitate, and the food goes rancid,

14 what will be the effect on the infant eating

15 this food, consuming this food?

16 MR. ANDERSON: Fatty oxidation is

17 very complex, but there's a lot of things when

18 fats oxidize. There's a lot of byproducts of

19 fat oxidation that would be considered then,

20 that would not be safe for infants. It's just

21 not a good thing to have, you know, oxidized

22 fats in any type of product, especially infant
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1 formula.

2 MS. RICHARDSON: Yes, but what

3 happens to the kid? You give it the formula,

4 did it throw up, get diarrhea?

5 MR. ANDERSON: You could have --

6 I'm not a doctor, but diarrhea is one example

7 that could happen.

8 MS. RICHARDSON: So it has some

9 like food safety aspects to it?

10 MR. ANDERSON: Yes, yes. I think

11 the FDA would be very concerned about oxidized

12 fats, which I think Sue Anderson had mentioned

13 earlier.

14 MR. FOSTER: Nick.

15 MR. MARAVELL: Yes. Just out of

16 curiosity, if you were to take dry infant

17 formula that would have a shortened shelf life

18 of three to six months, and instead of keeping

19 it on the shelf, put it under refrigeration,

20 what would be the impact of the shelf life,

21 and if it were labeled "keep refrigerated

22 until opened" or something like that?
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1 MR. ANDERSON: Refrigerated at

2 what, 45 or less? 

3 MR. MARAVELL: 45 degree

4 refrigerated temperatures?

5 MR. ANDERSON: Excuse me?

6 MR. MARAVELL: When you talk about

7 temperatures, what temperature are we talking

8 about, 45 degrees or less when you refer to

9 refrigerated temperatures?

10 MR. ANDERSON: Yes, approximately

11 41 degrees, yes. Well, it's never been

12 studied and I think in, you know, for this

13 product sold in the United States, this is not

14 a product where you find in a refrigerated

15 section. It's just I've never heard of infant

16 formula being sold that way. I don't know if

17 it's commercially viable.

18 MR. MARAVELL: Right. But what

19 might be the expected effects?

20 MR. ANDERSON: I wouldn't know. 

21 We've never studied it, just because in

22 commercial practice, that's not the way it's
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1 sold, distributed. So I don't have an answer

2 for that.

3 MR. FOSTER: Go ahead, Zea and

4 then Calvin.

5 MS. SONNABEND: My question is

6 similar to what I asked Dr. Anderson and Dr.

7 Bhatia. If you put in beta carotene to get,

8 enough to get Vitamin A activity, would that

9 also be enough quantity as an antioxidant, or

10 is it a different quantity that you're adding

11 for one or the other?

12 MR. ANDERSON: Typically, they're

13 different quantities, because antioxidants is

14 a very complex system. Sometimes, if you add

15 more of these substances, that can serve as a

16 pro-oxidant. It's very complex and there's

17 many, you know, there's many combinations, I

18 should say, of these substances added.

19 But the level that you find

20 typically in our product will be in a range of

21 two to four hundred IUs per liter. That level

22 would be similar to that found in human breast
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1 milk. It may have some antioxidant effect,

2 but typically antioxidants by definition are

3 added at very low levels.

4 MR. FOSTER: Thank you. Calvin.

5 MR. WALKER: If these two

6 materials are voted down, what would be the

7 impact? What would you do in terms of an

8 alternative?

9 MR. ANDERSON: For ascorbyl

10 palmitate, there isn't any. That's the honest

11 answer. There is none. It's a very, very

12 critical part of protecting this product. So

13 if the committee were to vote ascorbyl

14 palmitate out, we'd have a serious problem

15 with the viability of this product, commercial

16 availability.

17 MR. FOSTER: And last call? All

18 right. Thank you very much. 

19 MR. ANDERSON: Thank you.

20 MR. FOSTER: Next we have Eric

21 Lien or Lane. I apologize for not getting one

22 of those right, and then Diane Wilson on deck.
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1 DR. LIEN: Good morning. It's a

2 pleasure to be here to address you today. I

3 am currently adjunct professor, Department of

4 Food Science and Human Nutrition at the

5 University of Illinois. Previously, I was

6 Vice President of Nutrition Research at Wyeth

7 Nutrition and have more than 25 years of

8 experience in pediatric nutrition.

9 I'll provide a very brief

10 introduction to infant nutrition, talk about

11 three components of interest, taurine,

12 nucleotides and carnitine, and draw some

13 conclusions.

14 Birth weight of term infants

15 typically doubles in the first three to four

16 months of life. We realize that either breast

17 milk or formula may be the only source of

18 nutrition during this time. So it's important

19 that we find complete feeding systems.

20 What we realize is that human milk

21 is by far the preferred means of providing

22 nutrition to infants. If the mother cannot or
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1 chooses not to breast feed, then substitutes

2 of the highest quality must be available. 

3 Infant formula is really the only choice and

4 must meet all nutritional needs of the infant.

5 Let me move to components of

6 interest. Taurine functions. Taurine is

7 essential for retinal function. It's a

8 component of the predominant bioacid required

9 for fat absorption in term infants. As you

10 see in the draft here, it's found in

11 exceptionally high concentrations of human

12 milk, and exceptionally low concentrations in

13 both cow's milk and formula.

14 If we look at plasma taurine

15 levels during the first 12 weeks of life in

16 term infants, we see that breast-fed infants

17 have a substantial increase in taurine levels

18 during that time, and unsupplemented formula19 fed infants have a substantial decrease, with

20 a highly statistically significant difference

21 at the end of 12 weeks of life.

22 If we look at taurine function in
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1 the retina, retina function deteriorates

2 during taurine deficiency, and this is most

3 often seen in either pre-term infants or

4 individuals receiving total parenteral

5 nutrition.

6 Taurine supplementation can

7 reverse these abnormalities, and we can come

8 to the conclusion that taurine does play an

9 essential role in normal visual development. 

10 There's also data that indicates that taurine

11 supplementation or taurine plays a role in

12 cognitive, that is mental development, in

13 infants.

14 Let me briefly move to

15 nucleotides. These are simply the monomers of

16 RNA, so RNA being important in all genetic

17 expression. Nucleotides, when added to infant

18 formula, have three roles. They have a GI

19 anti-infective effect, less diarrhea during

20 the first year of life.

21 Immune system is closer to breast22 fed infants, improved immunoglobulin
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1 production to vaccines, for instance, and the

2 GI maturation effect, which permits nutrient

3 absorption, especially in small poor

4 gestational age term infants. A dietary

5 supply is essential during the first period of

6 rapid growth, such as during infancy. 

7 Finally, carnitine is essential

8 for the metabolism of fat. Carnitine couples

9 to fatty acid in the cytosol of the cell. 

10 That transports the fatty acids into the

11 mitochondria, where fatty acids then are

12 burned for energy.

13 Carnitine deficiency results in

14 increased urinary excretion of unburned fatty

15 acids, soy formulas and some milk-based

16 formulas require supplementation, and for

17 instance, the EU requires supplementation at

18 one point, two milligrams per hundred kcals of

19 soy formulas. Insufficiency may result in

20 hypoglycemia and failure to thrive. 

21 So I just will bring to conclusion

22 human milk and formulas must be complete
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1 feeding systems. I've discussed three

2 nutrients, taurine, nucleotides and carnitine. 

3 Taurine and carnitine have been added to

4 formulas for more than the last 25 years.

5 So we will not see deficiency

6 syndromes coming from feeding systems. These

7 nutrients support essential bodily functions,

8 and they should be included in infant formula. 

9 Thank you for your attention, and I'd be happy

10 to answer questions you may have.

11 MR. FOSTER: Questions? Zea.

12 MS. SONNABEND: Thank you. We

13 heard from our experts earlier that carnitine

14 is not required by the FDA, but L-methionine

15 is. One of the reasons cited was that if you

16 received enough L-methionine, your body could

17 make L-carnitine.

18 I'm wondering if what your

19 perspective is on that subject, and whether an

20 infant can create enough L-carnitine from an

21 L-methionine supplementation. 

22 DR. LIEN: This is a matter of
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1 maturation. Certainly as adults, who are

2 eating mixed diets, where we see dietary

3 carnitine. But vegetarians and vegans are

4 also capable of synthesizing L-carnitine.

5 Carnitine will increase in

6 production as the infant matures, but it is my

7 opinion in current infant formulas, if

8 carnitine is not present in sufficient

9 amounts, it should be added, to cover any

10 synthetic immaturity of the infant.

11 MR. FOSTER: Jean.

12 MS. RICHARDSON: My question is on

13 taurine. If, you stated that taurine is

14 essential, but it's not required. So can you

15 help us to understand why it's not required if

16 it's essential?

17 DR. LIEN: It's clear in

18 experiments in taurine deficiency that there

19 are problems of fat absorption and also of

20 visual maturation. The FDA approved taurine

21 for use in infant formulas in 1984, and it has

22 been added to all formulas since that time.
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1 We will not, under these

2 conditions, see taurine deficiency. Dr.

3 William Heird at the USDA Children Nutritional

4 Research Center in Houston, has indicated it's

5 his opinion that it would be at this point

6 unethical to do further experiments into

7 taurine deficiency, because it may lead to

8 untoward consequences, which I've indicated

9 here.

10 So it will be a very difficult

11 nutrient to remove from formula. We really

12 don't know what kind of situations we may put

13 infants who have true taurine deficiency in,

14 without that added component.

15 MR. FOSTER: Thank you. 

16 Additional questions? Colehour.

17 MR. BONDERA: Sorry about that. 

18 Thank you. I apologize, and thank you for

19 your testimony, Dr. Lien. I just, I apologize

20 that I may have missed this at the beginning.

21 But according to my sheet, and

22 according to what you're presented, I'd like
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1 you to not necessarily repeat your

2 qualifications, but who you're here

3 representing or what brings you here today? 

4 I understand and appreciate your,

5 you know, experience and presentation.

6 DR. LIEN: Thank you. I did

7 indicate in my qualifications that I am

8 retired Vice President of Nutrition Research

9 for Wyeth Nutrition, who was a manufacturer of

10 infant formula, and I have been here at the

11 request of the formula manufacturers.

12 MR. BONDERA: Thank you.

13 MR. FOSTER: Additional questions. 

14 Harold.

15 MR. AUSTIN: On these three

16 materials, are you aware of any formulas right

17 now, currently on the market, that do not

18 include these three products?

19 DR. LIEN: No, I am not. I should

20 indicate that for carnitine, there are some

21 milk-based formulas that have sufficient

22 endogenous carnitine, which is present in
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1 cow's milk. Not to add it, but they would

2 have more than the required amount for soy

3 formula already endogenously provided by

4 bovine milk.

5 MR. AUSTIN: Thank you.

6 MR. FOSTER: Thank you. Last

7 question, Calvin.

8 MR. WALKER: As it relates to

9 infants, does these deficiencies continue

10 after the infancy or breast feeding or milk

11 feeding period, these deficiencies that you

12 mentioned?

13 DR. LIEN: As we move through the

14 weaning process, introduction of what we'd

15 call complementary foods, these foods will

16 start to introduce these components to the

17 infant and young child through other sources.

18 The critical period is the time of

19 exclusive feeding. So that as long as six

20 months, and that's the time when we would be

21 most concerned, as a sole source of nutrition. 

22 We as adults have a mixed diet. If we're
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1 insufficient in one nutrient from some

2 component of our diet for a few days, it's

3 truly immaterial.

4 This very rapid growth rate may be

5 supported by only one source of nutrition. It

6 must be complete. 

7 MR. FOSTER: Thank you. All

8 right. I appreciate your time. Next, we have

9 Diane Wilson with John Ashby on deck.

10 MS. WILSON: Good morning, and

11 thank you for letting me be here today. I'm

12 Diane Wilson. I am Director of Nutrition

13 Services for Nature's One, the manufacturer of

14 organic pediatric medical nutritional

15 products.

16 I would like to remind this Board,

17 as I did at the May Albuquerque meeting, that

18 I'm not talking about infant formula; I am

19 talking about medical nutritional enteral

20 products. These are products that are for

21 medically nutritionally fragile children.

22 Our products are specifically for
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1 children, toddler to 13 years of age. These

2 are products that must be usually fed either

3 tube-fed by nose or through the stomach, in

4 order for the child to receive appropriate

5 nutritional care.

6 My comments are that if a nutrient 

7 is essential for infant nutrition, then it

8 obviously is going to be essential for a child

9 who requires medical nutritional care. My

10 request is that you amend your proposals to

11 include infant nutrition or infant formula

12 rather, and medical nutritional enteral

13 products.

14 In addition, the proposal for soy

15 isolate should be changed to soy protein. Our

16 products for older children, even though tube17 fed, contain soy protein concentrate and not

18 soy isolates. So please consider that

19 recommendation also from me.

20 Next, I want to remind you that at

21 the May meeting, the question arose as to

22 whether we would continue looking for organic
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1 alternatives to these essential nutrients that

2 unfortunately are synthetic.

3 My answer was of course we would. 

4 I used a different term, which I think got a

5 chuckle out of the group. But we did, and we

6 are. If you remember, choline was one of the

7 topics for the last meeting.

8 Since that time, we have found

9 that our toddler formula with DHA, which I

10 will remind you is not the algal fungal

11 sources of DHA and ARA, but egg phospholipid

12 source, a natural source, we have found that

13 we do not need to add choline bitartrate to

14 our formula with DHA, because the egg

15 phospholipid source provides the natural

16 choline needed to meet the child's nutritional

17 needs.

18 With that, I will close my

19 comments and then be more than welcome to

20 answer any questions. Thank you very much.

21 MR. FOSTER: Thank you. Do we

22 have questions? Jay.
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1 MR. FELDMAN: Thank you. Are your

2 products used by prescription only?

3 MS. WILSON: No.

4 MR. FELDMAN: So when you say

5 "medical," who's determining the medical need?

6 MS. WILSON: Well, they're not

7 exclusively used under medical --

8 MR. FELDMAN: I'm sorry. So can

9 you describe that product line that is -- is

10 there any product line that's prescribed?

11 MS. WILSON: I wouldn't say

12 they're prescribed. They're recommended, but

13 obviously for a child that's being tube-fed,

14 there are many alternatives.

15 But most of them are non-organic. 

16 I would say just about all of them are non17 organic, except for ours. So they would be

18 recommended by the health care professional.

19 MR. FELDMAN: Thank you.

20 MS. WILSON: I believe Dr. Bhatia

21 would agree. Hopefully you and your Committee

22 on Nutrition would agree that for a child in
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1 need of a medical nutritional enteral product,

2 these essential synthetic nutrients are

3 extremely important.

4 MR. FOSTER: We'll certainly put

5 that question in the queue for later

6 questioning. Thank you. Do we have more

7 questions for the commenter?

8 (No response.)

9 MR. FOSTER: Okay. Thank you very

10 much.

11 MS. WILSON: Thank you.

12 MR. FOSTER: Next, we have John

13 Ashby, followed by Peggy Miars.

14 MR. ASHBY: John Ashby with

15 California Natural Products. Once upon a

16 morning dreary, while I pondered weak and

17 weary; over many a quaint and curious volume

18 of the CFR, while I nodded, nearly napping,

19 suddenly there came a tapping, as of something

20 gently rapping, rapping at my chamber door.

21 'Tis Other Ingredients tapping,

22 tapping at my chamber door, only this and
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1 nothing more. But that is enough, Lenore. 

2 How distinctly I remember it was back in bleak

3 October when each separate incidental wrought

4 its ghost upon our door. 

5 From my books surcease of sorrow,

6 sorrow for the incidentals. Harmless barely

7 even present, whom the angels named Lenore,

8 called incidentals now and forevermore. In

9 the silken, sad uncertain future of processed

10 organics thrilled me, filled me with fantastic

11 terrors never felt before.

12 So that now, to still the beating

13 of my heart, I stood repeating "processed

14 foods, they are the gateway, in our now

15 organics heyday. Can they really be

16 destroyed? Our enemies won't be annoyed."

17 605 keeps processed growing,

18 unprocessed if we close the door them, growth

19 organics nevermore. Presently, my soul grew

20 stronger, hesitating then no longer. Sir,

21 said I or Madam, truly your forgiveness I

22 implore.
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1 But the fact is we've been

2 growing, and so gently you came rapping, and

3 so faintly you came tapping, tapping at my

4 chamber door, that I scarce was sure I heard

5 you, processed organics on the floor; growth

6 organics nevermore.

7 Perfection just cannot be met. We

8 go that way, we lose the bet. That feeds our

9 enemies and we have them. Think otherwise and

10 you will let them beat us. Please make no

11 mistake; the risk is real, this is the stakes. 

12 When we were small, we were no threat. Who

13 cares? So what? Big deal, no sweat.

14 But now it may just be our time,

15 and if we really mind the store, then growth

16 organics evermore. And organics never

17 flitting, still is sitting, still is sitting

18 on the milestone of our successes, just beyond

19 our reach and grasp.

20 But we must be both wise and

21 reasoned, careful, balanced, cautioned,

22 seasoned. If we do, then we can have, what it
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1 is we most desire, what can be weakened

2 nevermore, growth organics evermore.

3 Now I can't explain incidental

4 ingredients or technical effects in the food

5 if you wish. My bias is really so strongly,

6 does it increase or decrease organic acreage,

7 while keeping within whatever we define as the

8 sphere of maintaining that organic aspect well

9 enough.

10 But also don't let the perfect be

11 the enemy of the way better. You know, let's

12 remember there is a 100 percent category for

13 people who insist upon this. Processed growth

14 is the gateway, and I want to mention, this

15 opens in and it opens out.

16 A positive list of incidentals

17 runs the risk of wiping out huge sections of

18 processed foods, for reasons I'm happy to go

19 into. Okay, here it goes. 

20 Option A, I think legally

21 suffices. This is a food. Food has specific

22 way. It deals with the word "ingredients." 
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1 I agree with Zea. I think we need some

2 lawyers to get in on that.

3 Reviewing these things when we go

4 through it is just a wonderful, is a wonderful

5 idea. This is a good thing. It's the risk of

6 having a positive list that holds the specter 

7 open for finding something at parts per

8 trillion in a product, which then causes a

9 recall. You cannot build brands with that

10 kind of risk; you just can't.

11 By the way, the meter is trochaic

12 octameter. 

13 MR. FOSTER: Well, let this former

14 Literature major say, thank you for that. It

15 warms my heart, and certainly appropriate in

16 the -- just down the street from the

17 birthplace of Edgar Allen Poe, of course.

18 MR. ASHBY: And in a ghost hotel.

19 MR. FOSTER: Indeed, indeed. Do

20 we have questions for Mr. Ashby? Yes, you

21 will be needing to use iambic pentameter for

22 your questions. Or free form. Free verse is
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1 fine. No questions.

2 I would ask for a copy in writing

3 of that little diddy, if you don't mind.

4 MR. ASHBY: Okay. I'll get it to

5 you. Okay, thank you.

6 MR. FOSTER: Thank you very much. 

7 Next we have Peggy Miars, followed by

8 Gwendolyn Wyard.

9 MS. MIARS: Thanks, Michelle, for

10 putting me after that. 

11 (Laughter.)

12 MS. MIARS: Good morning. My name

13 is Peggy Miars, and I'm Executive Director of

14 OMRI, the Organics Materials Review Institute. 

15 My comments today will focus on the Other

16 Ingredients discussion document that was

17 brought by the Handling Subcommittee.

18 OMRI provided written comments on

19 this subject as well, and as a participant in

20 the Materials Working Group, OMRI also

21 provided input to the various options

22 presented by the Subcommittee, including some
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1 of the pros and cons that were listed for

2 each.

3 My comments today address two

4 specific points about the importance of

5 adopting a policy, and carefully considering

6 the evidence that's presented to you by

7 various stakeholders with experience on this

8 issue.

9 First, I want to reiterate the

10 importance of adopting a policy to address

11 this issue. However, before doing so, the

12 NOSB should understand the scope of Other

13 Ingredients currently being used and their

14 purpose, as some commenters have suggested, to

15 understand the impact of your recommendation

16 on the organic marketplace.

17 The presence of Other Ingredients

18 and their allowance has been a source of

19 confusion or inconsistency for many years. 

20 Although OMRI has been consistent in our

21 approach to this issue, our daily interactions

22 with certifiers discussing Other Ingredients
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1 tell us that there is a range of approaches

2 to, and interpretations of this issue.

3 The NOSB has not been consistent

4 in how it has recognized, reviewed and

5 annotated other ingredients. So we're happy

6 to see you address this issue and treat it as

7 seriously as it deserves to be treated.

8 We hope that you will take into

9 account the many opinions and comments, and

10 decide on a reasonable policy that's both

11 practical and that protects the integrity of

12 the organic label. 

13 OMRI's policy on Other Ingredients

14 is actually a combination of Option C that's

15 presented in the discussion document, and

16 Option D, as presented in some organization's

17 public comments, including the Cornucopia

18 Institute and Beyond Pesticides.

19 We would like to offer our

20 experience as one of the few organizations

21 that has practiced the alternative Option D. 

22 This alternative option proposed by these
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1 organizations stipulates in a nutshell that

2 Other Ingredients be organically produced or

3 be on 205.605 or 205.606.

4 OMRI's policy has always been to

5 require that Other Ingredients be organically

6 produced, or be provided for in the

7 annotation, or be on 605 or 606. In rare

8 cases, we've allowed Other Ingredients that

9 have explicitly appeared in the technical

10 review.

11 OMRI lists processing inputs that

12 are generally comprised of 605 or 606

13 materials, such as yeast ingredients,

14 defoamers, food sanitizers such as fluorine

15 and peracetic acid, and formulated ingredients

16 such as fruit coatings.

17 OMRI's list of processing inputs

18 is meager compared to the possible thousands

19 of ingredients in processing aids used in

20 organic foods today, and we attribute this

21 lack of growth in our list to two reasons.

22 One, the policy for allowing Other
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1 Ingredients from the NOP and NOSB has been

2 inconsistent and led to varying

3 interpretations, and two, most ingredients and

4 processing aids do not comply with OMRI's

5 strict interpretation and policy.

6 So the NOSB may want to consider

7 OMRI as a real life example of how Option C

8 and Option D may play out if implemented. I

9 want to make it clear, OMRI takes no position

10 on the appropriateness of any specific policy. 

11 However, we do urge you to look at the

12 evidence presented, to formulate your final

13 recommendation as soon as possible. Thank

14 you.

15 MR. FOSTER: Thank you for that. 

16 Any questions? Zea.

17 MS. SONNABEND: Thank you, Peggy. 

18 I'm wondering how comfortable OMRI reviewers

19 feel with going back to look for potential

20 Other Ingredients in the TRs and petitions, as

21 opposed to having a centralized database

22 through the NOP, where those things would
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1 exist?

2 MS. MIARS: I'm sorry. I'm not

3 quite sure I understand that question. Can

4 you restate it?

5 MS. SONNABEND: Well, do you find

6 that it's a problem to have to go searching

7 through a lot of TRs and petitions when

8 determining if Other Ingredients were reviewed

9 in the initial review, versus the convenience

10 of having everything in one place, which may

11 or may not be, have the funding to be kept up,

12 for instance, or have other issues?

13 MS. MIARS: Well obviously, it

14 would be much easier just to go to a database

15 or spreadsheet. However, I do know that our

16 reviewers do go back to technical reviews on

17 a regular basis, to do as part of the research

18 for our product reviews.

19 MR. FOSTER: All right. There's

20 some more questions. Jay and Nick. MR.

21 FELDMAN: Thanks, Peggy. This is a question

22 for OMRI. I'm hoping we can get an answer
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1 before we have to vote or in further

2 discussion on this issue of soy protein

3 isolate, and these distinctions being made

4 between isolate and concentrate, and how it's

5 derived, how it's formulated. Is that

6 something you can help us with?

7 MS. MIARS: Well, that's not an

8 area that I'm knowledgeable of, so I would

9 defer technical questions to my colleague,

10 Lindsay Fernandez-Salvador.

11 MR. FELDMAN: Okay, thank you.

12 MR. FOSTER: Nick.

13 MR. MARAVELL: Yes. Just out of

14 curiosity, at OMRI, you wouldn't happen to

15 have your own little personal crib sheet or

16 cheat list that would sort of serve the

17 secondary purpose of a database, as you go

18 through and review materials, and review the

19 technical reviews, et cetera. 

20 Do you actually sort of keep a

21 tally of what we might be calling Other

22 Ingredients, with annotations as to under what
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1 circumstances these surfaces, et cetera?

2 MS. MIARS: Sure. We do keep

3 detailed information like that in our

4 database, because we do see certain materials

5 come up time and time again. So it does make

6 sense for us to maintain those records and

7 refer back to them on a regular basis.

8 MR. FOSTER: Thank you. Last

9 question. No? Thank you, Peggy.

10 MS. MIARS: Thank you.

11 MR. FOSTER: Coming up is

12 Gwendolyn Wyard, to be followed by Britt

13 Lundgren.

14 MS. WYARD: Okay, top of the

15 morning. Mr. Chairman and OP staff and ladies

16 and gentlemen of the gallery. My name is

17 Gwendolyn Wyard. I'm the Regulatory Director

18 of Organic Standards and Food Safety for the

19 Organic Trade Association, representing over

20 6,500 members across 48 states.

21 I also serve on the OMRI Board,

22 and I'm co-chair of the Materials Working
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1 Group. First, I want to thank you so much for

2 your dedication, and for the 239-page proposal

3 packet that was prepared for this meeting. I

4 truly appreciate the full time job security

5 your voluntary positions provide me.

6 (Laughter.)

7 MS. WYARD: We did submit comments

8 on ten of the proposals. You have those in

9 writing. My comments today will focus on

10 Other Ingredients, Other. 

11 First and foremost, I want to be

12 perfectly clear that OTA supports a careful

13 and thorough review of Other Ingredients. How

14 that review is documented and how allowances

15 and prohibitions are communicated to

16 certifiers and material review organizations,

17 MROs and industry is the crux of our

18 challenge.

19 Historically, the review of Other

20 Ingredients contained within petitioned

21 substances was part of the overall review

22 process. In most instances, the substance and
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1 the other ingredients were specifically or

2 generically acknowledged, and the entire

3 substance in its totality was evaluated

4 against OFPA and the National List criteria,

5 and added to the National List.

6 Over the years, the Board has

7 proposed several multi-ingredient or multi8 component substances to the National List. 

9 Examples include enzymes, vitamins, dairy

10 cultures and natural flavors.

11 These substances are functionally

12 dependent on other ingredients, meaning they

13 cannot be used, they cannot exist, they cannot

14 be used for food application without them. If

15 you purchase Vitamin D, you would never

16 purchase Vitamin D by itself. It would always

17 come with a dispersing agent.

18 The problem is that the review of

19 generic materials at the NOSB level has not

20 been consistently carried out and documented,

21 as Zea pointed out, and accordingly,

22 certifiers, MROs and industries face
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1 uncertainties when trying to figure out which

2 other ingredients are allowed in brand name

3 products.

4 The good news and an important bit

5 of perspective is that not all substances on

6 the National List depend on other ingredients. 

7 In fact, most do not. Out of the 139 handling

8 materials on the National List, there are

9 about 12 that require other ingredients.

10 But they're a critical 12, and

11 they're commonly used in the organic foods

12 that we love and consume daily, and they've

13 been allowed for over ten years.

14 A large majority of the substances

15 on the National List were reviewed and added

16 as single component substances, and they

17 should remain just that. Any other ingredient

18 would need to be organic or on the National

19 List, because they were not reviewed or

20 considered by NOSB.

21 As for the multi-component

22 substances, we believe we need to take a case-
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1 by-case approach, just as they have previously

2 been reviewed, and we have our work cut out

3 for us. OTA's comments present a seven-step

4 procedural plan, spread out over the next

5 three NOSB meetings.

6 I don't have time to discuss each

7 step, but I will say that the first step needs

8 to begin now, and it needs to be an

9 assessment. We need to invite industry to go

10 back and look at their products, and look at

11 what other ingredients are being used.

12 Separate single component

13 substances out from the multi-component

14 substances. Examine the collected information

15 from industry and address each multi-component

16 substance accordingly. For the 12 or so

17 listings that require other ingredients, use

18 annotations to set restrictions and

19 prohibitions when it's appropriate.

20 This is consistent with historical

21 practice, and we believe NOSB has the

22 authority to continue this discretion. Take
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1 natural flavors, for example. In '95, the

2 Board considered the fact that carriers and

3 preservatives, which are Other Ingredients,

4 are always added to compounded flavors.

5 They didn't say they all needed to

6 be on the National List. Instead, they said

7 they needed to be non-synthetic, and they

8 annotated the material as such and added that

9 material in its totality to the National List.

10 In conclusion, you cut off my mic? 

11 Oh, sorry. Well in conclusion, thank you very

12 much. This is the nuts and bolts of our

13 policy, and we've basically taken elements of

14 Option A, B and C, and pointed out the key

15 factors that we'd like to see worked into our

16 policy. Thank you very much.

17 MR. FOSTER: Thank you. 

18 Questions? Mac.

19 MR. STONE: So I'll ask you this

20 incidental additives that don't have a

21 technical or functional effect. How are they

22 there, and again the confidentiality in
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1 developing these products, or disclosure of

2 confidentiality?

3 MS. WYARD: Okay. I'll take that

4 in the two parts. So why they're there. In

5 a finished, certified product, the other

6 ingredients are these incidental additives. 

7 They are present by way of an ingredient

8 that's been added to that finished product.

9 So the finished product, the

10 consumer's looking at the finished product. 

11 They're reading the ingredients statement, and

12 the ingredients statement will read "Vitamin

13 D." Within that Vitamin D, you may have

14 dispersing agents or stabilizers or

15 preservatives. 

16 They were added to the Vitamin D

17 during the manufacturing of the Vitamin D. 

18 They were not added to the milk, for example,

19 but they're present in the milk by way of

20 being carried in through the Vitamin D.

21 So in the finished product, which

22 would be the milk, they are present at
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1 insignificant amounts, and they do not have a

2 technically functional effect on the milk. 

3 They had a technically functional effect on

4 the Vitamin D, acting as other stabilizer

5 preservatives, et cetera.

6 Confidentiality for most of the

7 substances on the National List, for 605 and

8 606, really is not that big of an issue. 

9 Unlike crop products, where trying to get

10 disclosure of the inerts is very proprietary,

11 the specification sheets that come along with

12 the ingredients that are being used by

13 certified handlers, those specification sheets

14 list the other ingredients that are in that

15 ingredient.

16 So if you are using an enzyme,

17 you're going to get a specification sheet

18 that's going come in with that enzyme, and

19 it's going to list the other ingredients that

20 are there. Certifiers can readily look at

21 them. The manufacturer of the ingredient is

22 required to provide the handler with an
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1 ingredient list of those other ingredients.

2 There are some exceptions, and

3 those exceptions would largely be natural

4 flavors, very proprietary. You will actually

5 get the list of the other ingredients in a

6 natural flavor. What you won't get is the

7 proprietary formulation of all of the flavor

8 constituents.

9 But even in natural flavors, you

10 will, you know, they'll disclose the glycerine

11 is being used, for example, as a carrier, or

12 maltodextrin is being used as a carrier.

13 Colors, you would run into also some

14 proprietary information. But again, that

15 would be for the specific color constituents

16 and not so much the other ingredients.

17 MR. FOSTER: Thank you. 

18 Additional questions? Nick.

19 MR. MARAVELL: I'm going to change

20 the subject here Gwen, and go a little

21 philosophical. I'm going to quote from your

22 conclusion of your prepared remarks. In
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1 effect, you're saying we believe that NOP

2 certified products should be nutritionally

3 equal to their conventional counterparts.

4 For me, the philosophical part of

5 that comes in. Does there need to be a

6 conventional, I mean an organic product sort

7 of standing analogous side by side with every

8 conventional product, and is that sufficient

9 justification for adding things such as

10 synthetic preservatives?

11 So let me go one step further. So

12 how, what's the impact on the industry if your

13 conclusion is not one that is accepted, versus

14 accepting that conclusion? What's the impact,

15 the positives and the negatives, on the

16 organic industry?

17 MS. WYARD: Well I think, you

18 know, OTA has gone on record several times,

19 stating that, you know, we support consumer

20 choice. We support consumer preference, and

21 we envision the day, and I think we're getting

22 there, where organic products are a
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1 significant part of our everyday life.

2 So to every extent that it's

3 possible, there's going to be caveat here, and

4 a huge one. But to every extent possible, I

5 would hope that we're all striving to create

6 as many organic products as we possibly can,

7 and that we would create an organic

8 counterpoint to every conventional product out

9 there.

10 Now I know this gets into the

11 organic Twinkie argument, and I'm not going to

12 go there fully. But the caveat is that we

13 have to do this in full compliance with OFPA

14 and the regulations. There is no skirting

15 around that. We would never suggest that we'd 

16 do that.

17 If you look at the criteria that

18 are listed out in OFPA for putting materials

19 on the National List, we all know they're

20 rigorous and it's -- here we are going through

21 this process.

22 So I think if you follow the OFPA
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1 criteria and the National List criteria and

2 the regulations, then we should have a list of

3 ingredients that are consistent with organic

4 principles, and we should be able to make

5 products that comply with the regulations.

6 I think bringing personal choice

7 in to the matter, in terms of whether you

8 believe infant formula is right or wrong is

9 irrelevant. It's whether or not the product

10 complies with the regulations, and the

11 screening step that takes place prior to that

12 is the, this process that we're all here going

13 through right now.

14 MR. FOSTER: Harold.

15 MR. AUSTIN: I think you partially

16 answered this, Gwen. But on one of your

17 slides, how would you suggest that we conduct

18 assessment of the National List, and what

19 would this ultimately do for us, as we're

20 trying to work through and develop this

21 policy?

22 MS. WYARD: So the first step is
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1 to begin this assessment, and I think this

2 assessment should and can happen now, and OTA

3 is absolutely ready and willing to help with

4 that process, in terms of outreach to industry

5 and notification to industry, to go and

6 conduct a very thorough assessment of the non7 organic ingredients that they're using in

8 their certified products, and then going back

9 to the manufacturers of those ingredients and

10 finding out exactly what other ingredients are

11 in those approved substances on the National

12 List.

13 I think we need to understand the

14 universe that we're operating in, in the same

15 way that has been conducted for the inerts. 

16 For the inerts, you know, you have an idea of

17 these 126 inerts that you're working with,

18 broken into their classes.

19 We have no idea how many other

20 ingredients are in use out there. So I think

21 that's a first step and also, you know, we

22 have the work that's already in the discussion
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1 document, the spreadsheet at the end that goes

2 through and it did a review of all of the

3 technical reviews and the petitions.

4 So we have a pretty good idea, and 

5 so that's what I base that number 12 on. As

6 far as this list right here, these are the

7 multi-component substances. These rely on

8 other ingredients. We already have a lot of

9 information. They were approved in 2000, well

10 '95, and they've gone through a couple of

11 sunset processes.

12 We have a lot of information, but

13 we don't have a thorough assessment of what is

14 being used out there. But we can at least

15 say, you know, let's focus on this 12, and

16 let's verify that it is just 12 that we're

17 talking about. What have we missed, waxes, et

18 cetera, et cetera.

19 I haven't included the sanitizer,

20 disinfectants and cleaners here. That is

21 another issue, certainly all one in the same

22 topic. But I think that's the first step, is
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1 to conduct this assessment, and you know, at

2 that point, if we're only dealing with 12, it

3 kind of helps to find our universe. It makes

4 it a little bit easier.

5 Then you can take it, you know,

6 one by one, because if you're talking about

7 vitamins and minerals, and this would also

8 apply to vitamins and minerals used in

9 certified livestock feed. So in that case,

10 it's not going to be just human foods.

11 If you want to say that every

12 other ingredient needs to be organic or on the

13 National List, and all the vitamins and

14 minerals that are being used in processed food

15 for humans and for livestock, that's going to

16 be a huge train wreck. It's also going to be

17 a regulatory bottleneck, to try to go through

18 a petition process to deal with all of those

19 other ingredients, and that's just in vitamins

20 and minerals.

21 So that's why we're recommending

22 that we use annotations, and I think this
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1 assessment and looking, doing a case-by-case

2 review of these 12 substances, can help us

3 define and say well, let's do what we did with

4 natural flavors. We say only non-synthetic

5 other ingredients can be allowed.

6 Or maybe in one instance there's,

7 you know, a few enough other ingredients being

8 used that you can put it in the permitted

9 substance database, or just document in the

10 background. The point is that there are 12

11 different substances, and they really need to

12 be dealt with on a case-by-case basis.

13 So and I think if you look between

14 now and spring of 2014, you can get that work

15 done maybe. This is just a suggestion for a

16 road map. But it's just a way to start

17 thinking about this process.

18 MR. FOSTER: Terrific. Thank you. 

19 Jay, this will need to be the last one.

20 MR. FELDMAN: Okay, thanks.

21 MR. FOSTER: We only have ten

22 minutes here.
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1 MR. FELDMAN: Okay. Just quickly,

2 then. I'm just trying to decipher how you're

3 looking at the listing, the word "listing" on

4 the National List. So there's that footnote

5 in the discussion document that, you know,

6 recited the findings of the court, you know,

7 on this question of Other Ingredients or

8 processing aids, and basically said that,

9 authorized the use of synthetic substances

10 when ingredients or processing aids for use in

11 handling operations, so long as they appear on

12 the National List.

13 So you're equating this sort of

14 grouping as a listing. Is that how you're

15 interpreting that, compliance with that

16 finding by the court?

17 MS. WYARD: I wouldn't call it a

18 grouping. I would say a substance. A

19 substance can contain multiple ingredients. 

20 So if you, you know, OFPA states that a

21 handler must use ingredients that are either

22 organic or on the National List.
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1 So dairy cultures, that is an

2 ingredient. So if a handler is using a dairy

3 culture, the handler is using an ingredient

4 that is on the National List. Further on in

5 OFPA, it states that NOSB needs to add

6 substances to the National List.

7 So now we've moved into, you know,

8 we were using ingredients earlier on, and now

9 we're talking about substances. But there's

10 also further on and off where there's -- and

11 I think that Zea put it up in her

12 introduction, where it points out that a

13 substance can be a multi-component substance. 

14 It can contain other ingredients.

15 So this is where we get in to

16 these two school of thoughts that Zea

17 presented in her presentation. What does it

18 mean if an ingredient is on the National List? 

19 If a substance is on the National List, does

20 that include, in its totality, those other

21 ingredients?

22 The only thing that I can tell is
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1 clear is that it's not clear, just as Zea

2 presented, and I won't comment any further

3 there. I think it does definitely get into

4 legal land, and I'm not a lawyer, and that's,

5 I think, where that needs to go.

6 MR. FOSTER: Thank you very much.

7 MS. WYARD: Thank you very much.

8 MR. FOSTER: And just while we're

9 changing here, Britt's coming up, I've already

10 had four requests for John Ashby's - four

11 email requests for John Ashby's, so make it

12 five. Yes, Yes. So you may want to print it

13 in a pamphlet or something. 

14 John Ashby will have a signing

15 party in the lobby in the Renaissance Room

16 after the proceedings. So Britt, thank you

17 for your indulgence of our jocularity, and

18 then next up is Elizabeth Johnson.

19 MS. LUNDGREN: Hi. Thank you for

20 this opportunity to comment. My name is Britt

21 Lundgren. I'm the Director of Organic and

22 Sustainable Agriculture at Stonyfield, which
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1 is the world's leading organic yogurt company.

2 At Stonyfield, we appreciate that

3 the NOSB has decided to look more closely at

4 the use of other ingredients in substances

5 allowed on the National List.

6 We agree with the Handling

7 Committee's assessment that while the overall

8 ingredient review process is already quite

9 rigorous, improvement and harmonization of

10 this process would be beneficial.

11 We support the establishment of a

12 more clear and consistent process to review

13 other ingredients, because it will promote

14 even greater transparency within the standard,

15 and also provide greater certainty for

16 processors such as ourselves.

17 In general, I think our position

18 on this could be best described as Option B of

19 the Handling Subcommittee's options, with

20 variations. As Zea said earlier, a lot of us

21 have tweaks to that. 

22 We believe that this is the best
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1 way for NOP to ensure that all other

2 ingredients are evaluated in the process of

3 evaluating substances for inclusion the list,

4 without creating an onerous new set of

5 requirements.

6 We believe that Policy Option C

7 does nothing to advance the actual integrity

8 of organic products, but could create a

9 regulatory bottleneck for the agency, and thus

10 hinder the future growth of organic

11 agriculture.

12 Before NOSB settles on a policy

13 for evaluating other ingredients, like OTA we

14 suggest that the first step is to conduct a

15 more thorough inventory of other ingredients

16 that already in use in allowed substances. 

17 In many cases, these other

18 ingredients have already been reviewed as part

19 of approval and sunset processes, while in

20 some cases we may not be aware of the other

21 ingredients that are in use in a substance.

22 By defining and thoroughly
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1 investigating the scope of this issue first,

2 NOSB can then design a policy that is more

3 appropriate for the problem in hand. For some

4 substances, it may be most effective to

5 specify the allowance or prohibition of

6 individual other ingredients.

7 In others, it may be more

8 appropriate to allow or prohibit a functional

9 class of other ingredients, or to allow other

10 ingredients based on regulatory reference

11 under another government agency. The point is

12 that a one-size-fits-all policy for evaluating

13 other ingredients may be inadvertently

14 restrictive, or it could result in NOSB having

15 to review many individual other ingredients,

16 when a simple annotation to approve a

17 functional class of ingredients would suffice.

18 For certain proprietary

19 formulations, it may not be possible for NOSB

20 to have full access to a complete list of

21 other ingredients used, and in this case, it

22 should be up to the certifying agency to
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1 evaluate these other ingredients.

2 By first reviewing all allowed

3 substances to determine which are likely to

4 have other ingredients, and which of these are

5 likely to be of a proprietary nature, the NOSB

6 can be in a better position to provide

7 appropriate guidance to certifying agencies

8 about how to evaluate these other ingredients,

9 as they have done in the case of natural

10 flavors.

11 Once the review of other

12 ingredients is complete, the NOSB can use what

13 they have learned in this review to develop a

14 policy for evaluating other ingredients. This

15 policy should be designed to foster more

16 transparency within the standard, by requiring

17 the technical evaluation report and any other

18 review done by NOSB, to always note any

19 presence of other ingredients, and establish

20 either specific allowances or restrictions as

21 appropriate.

22 NOSB should also develop guidance
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1 for certifying agencies on how to evaluate

2 these other ingredients. That's it. Thank

3 you.

4 MR. FOSTER: Thank you. Do we

5 have questions? 

6 (No response.)

7 MR. FOSTER: All right. Thank you

8 very much.

9 MS. LUNDGREN: Thanks.

10 MR. FOSTER: Next up, we have

11 Elizabeth Johnson, followed by Deborah

12 Trinker.

13 MS. JOHNSON: Good morning. I'm

14 Elizabeth Johnson from Tufts University, where

15 I work in the Carotenoids and Health

16 Laboratory, and where I've been working for

17 more than 20 years, looking at the role of

18 carotenoids in human health.

19 There's been a lot of talk about

20 lutein this morning, and I'm here to tell you

21 what it is and where we find it in the body. 

22 Lutein is a plant pigment. You find it common
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1 in our diet. It's part of the carotenoid

2 family. 

3 There are hundreds of carotenoids

4 in nature. We see them this time of the year,

5 the reds, the yellows, the oranges. But of

6 those hundreds, only two get in the eye,

7 lutein and its isomer, zeaxanthin. In the

8 eye, it has a role as an antioxidant in vivo. 

9 It's an anti-inflammatory and it's a blue

10 light filter.

11 So that lends a lot of strong

12 biological plausibility that it's important. 

13 What really makes a lot of plausibility to its

14 biological importance is that we find a

15 specific binding protein for lutein in the

16 eye, and in biology, when you find a specific

17 binding protein for something, that really

18 lends support for it being important.

19 In the eye, the concentrations of

20 lutein are 500 to 1,000 times more

21 concentrated than anywhere in the body. The

22 only way you get it in there is if you eat it. 
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1 Now the role for lutein in neural health, a

2 lot of that comes from what we know in adults.

3 We know that lutein preferentially

4 accumulates not only in the eye, but in the

5 brain as well. There's a lot of double6 blinded placebo-controlled trials, which are

7 the golden standard when it comes to nutrition

8 research, that show that if you give lutein,

9 you improve cognition, you improve visual

10 function.

11 So we know a lot of the

12 epidemiology, we know the clinical work, we

13 know the intervention trials support a role

14 for lutein in eye health and in cognitive

15 function in the adult.

16 Now a lot of what we know about

17 lutein as an in vivo antioxidant, as an

18 inflammatory, as a structural role, a lot of

19 what we know in the adult, we can really

20 expect that to be true in the infant. Its

21 role as an antioxidant and anti-inflammatory

22 is structural.
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1 So in the adult, when we look at

2 lutein status, whether it be in diet, whether

3 in blood, whether it be in brain, we have

4 data. More lutein in the brain, better

5 cognitive function. Those roles of lutein

6 should apply for the infant as well.

7 Now when we look at brain tissue

8 of the adult, the major dietary carotenoid in

9 brain is lutein. It's not beta carotene, it's

10 not lycopene. Despite having increased levels

11 of these other carotenoids, the brain takes

12 that lutein out, just like it does in the

13 retina.

14 For the infant, it's the same

15 story. We've analyzed infant brain that died

16 of natural causes, mostly SIDS, and when we

17 look at the all the carotenoids in their

18 brain, 60 percent is lutein. We analyze these 

19 brains in the first year of life, and we know

20 they're not eating lutein in their diet. It's

21 probably taken up in the brain, where we think

22 it's function.
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1 There have been studies defined

2 that if you give lutein to infants that are on

3 formula, that otherwise wouldn't have lutein,

4 better antioxidant function. Then that

5 implies there's going to be less formation of

6 something called lipofuscin, which is a long 

7 term increased risk of eye health towards

8 later in life.

9 So there's a functional role that

10 we know, of lutein in the eye, that we can

11 really apply to what's going on in the brain

12 as well. So knowing that breast milk contains

13 lutein, that without lutein in early life that

14 you'll see decreased levels of lutein. This

15 really has implication for its role being

16 added to infant formula. So I thank you for

17 your time. 

18 MR. FOSTER: Nice timing. 

19 Questions from the Board? All right, Zea.

20 MS. SONNABEND: Thank you. Do you

21 know how the lutein is made?

22 MS. JOHNSON: It's a plant
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1 pigment, very common to our diet, our green

2 leafys. And when we look at it not being in

3 the diet, the studies we've done in monkeys,

4 if you don't have it there, you see some

5 abnormal morphological differences in the

6 retina that are related to worse functioning.

7 MS. SONNABEND: But do you have

8 any knowledge of whether the lutein that would

9 be fed to the infants is the same exact lutein

10 that's in the plants?

11 MS. JOHNSON: That's where almost

12 all of our lutein comes from, is a plant

13 extract. It's pretty expensive to synthesize,

14 so you really want to go for a plant extract,

15 and I don't know anyone that synthesizes it

16 for commercial reasons.

17 MR. FOSTER: Additional questions? 

18 Harold.

19 MR. AUSTIN: Based off of all of

20 the research that you've been doing with it in

21 the University, what do you feel the

22 significant impact to the infants would be if
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1 they were lutein-deficient during their growth

2 development?

3 MS. JOHNSON: Well, our best

4 evidence comes from the work that we've done

5 in primates and monkeys, where they actually

6 never, ever were exposed to a carotenoid in

7 their life. When you look at their retinas,

8 it's not normal. It's not normal at all.

9 But when we fed lutein back to

10 those retinas, there's these certain cells in

11 the retina that they kind of traffic the

12 nutrition coming in, the waste products going

13 out, and that profile becomes distorted.

14 When we add lutein back to their

15 diets, you can repair that. To me, that's

16 pretty compelling, to see something like that

17 going on.

18 So it's, you know, it's pretty

19 important, and to find that there's this

20 specific binding protein, which I had

21 mentioned earlier, that to me is pretty strong

22 biological evidence that it's important, when
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1 we have evolved to have this protein to zap,

2 to bring it out of the circulation, to put it

3 in the retina exactly where it needs to go.

4 I mean most of us in the room are

5 thinking more about preserving the neural

6 tissue that we have, and one of the major

7 problems we have right now is age-related

8 macular degeneration. I bet everyone in this

9 room can raise their hand, because they know

10 someone who has this.

11 Lutein is in the macula. It's 500

12 times more concentrated there, where it is a

13 blue light filter. The light coming in is

14 blue light. It's a yellow pigment. It grabs

15 that blue light, so it can't go on to those

16 photoreceptor cells and damage them. Light is

17 damaging.

18 The eye is very vulnerable to

19 light damage. It's not like your liver or

20 bones. It's damaging. So we want to protect

21 it with a blue light filter, with an

22 antioxidant, with an anti-inflammatory.
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1 MR. FOSTER: Any additional

2 questions?

3 (No response.)

4 MR. FOSTER: Great. Thank you

5 very much. Next up, I'm showing Deborah

6 Trinker, followed by Helen Kor.

7 MS. TRINKER: Good morning. My

8 name is Debbie Trinker. I'm the Vice

9 President of Regulatory Affairs for Kemin

10 Foods, LC.

11 I appreciate this opportunity to

12 appear before the Board, and to provide this

13 statement in support of the addition of lutein

14 USP to the National Organic Standard Board's

15 list for use in organic formula.

16 We're in the manufacture of

17 Floraglo brand of lutein, and we are the

18 petitioner requesting this addition under

19 Section 205.606.

20 My comments this morning will

21 address some of the new scientific and other

22 information that I was disappointed to see was
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1 not in the Technical Report, that we think is

2 relevant to your review of this ingredient.

3 Also, when I look at your

4 definition of an accessory nutrient, if it

5 provides an optimal health benefit and there

6 is no viable organic alternative, then this

7 ingredient should be considered and included

8 on the list. Those are the points I'd like to

9 make today.

10 I'd also like to take a little bit

11 of time to discuss some of the issues that

12 came up that are not in my prepared statement,

13 regarding why we listed this ingredient under

14 205.606.

15 We believe that lutein USP is an

16 agriculture product under this section. It's

17 derived from a botanical source, marigold

18 flowers, with minimal processing, and it

19 retains its essential agriculture

20 characteristic.

21 It is a pigment, a xanthan-filled

22 pigment, and in fact under FDA regulations, we
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1 are required to label it when it appears in

2 the supplement as lutein, identifying its

3 botanical source and part of the plant, i.e.,

4 the marigold flower.

5 When we prepared the petition, it

6 was our understanding, and we did provide

7 quite detailed information on our

8 manufacturing process, and some of that was

9 labeled as CBI, and it was our understanding

10 that that would be reviewed and would be

11 considered.

12 In the interest of transparency, 

13 I can briefly summarize how we process this. 

14 There is a solvent used. Hexane is used to

15 extract the xanthan fills from the marigold

16 petals, to create the oleoresin, and this is

17 necessary.

18 The use of synthetic chemicals or

19 solvents under this Board's recommendations

20 would not in and of itself render the

21 substance as synthetic, and I refer to the

22 NOSB recommendation for classification of
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1 materials in 2009, and unless there is a

2 chemical alteration of the substance or the

3 synthetic material occurs in the resulting

4 product and is not removed.

5 When we test our crystalline

6 material, we find that the hexane is not

7 detectable. There's a second step in this

8 process, and it's de-estrification step.

9 And if I can go back for a minute,

10 we've also looked at these steps in terms of

11 other substances that you've allowed under

12 this listing, and we find precedent with

13 unbleached lecithin, where hexane is used as

14 a solvent.

15 A second step that is of interest

16 to this discussion and this Board's review is

17 the de-estrification step, and that provides

18 lutein in the free form in which it appears in

19 breast milk.

20 This step uses a processing aid

21 that appears on your list as a substance that

22 may be used in processing, as a processing
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1 agent organic handling under 205.605, and the

2 precedent here would be the HMP and LMP

3 pectines, which are proposed to be

4 consolidated under 7 C.F.R. 205.606.

5 Such that our conclusion, to be

6 consistent, is that the de-estrification

7 process, in and of itself, does not render

8 this as a synthetic product. 

9 I want to talk briefly about

10 essentiality. I'm a food and drug lawyer. 

11 That's been the bulk of my practice, and the

12 listing of ingredients that are allowed in

13 fortification are based on having DVs.

14 That doesn't mean that this

15 ingredient, per Dr. Johnson, is not critical

16 to infant development. Just as one final

17 comment that I'd like to make, because there's

18 been a lot of discussion of EFSA, we define

19 infant formula specifically under our laws,

20 under the Food and Drug Act, and infant

21 formula is supposed to simulate human breast

22 milk, and lutein is in human breast milk at
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1 significant levels.

2 So this is consistent with the

3 statutory definition that the Food and Drug

4 Act has, that FDA uses, not what FC uses. 

5 Thank you very much.

6 MR. FOSTER: Thank you. Do we

7 have questions? Harold.

8 MR. AUSTIN: Thank you for coming

9 and clearing up some of the complications that

10 we are running into a little bit. 

11 MS. TRINKER: Sure.

12 MR. AUSTIN: I know your original

13 petition was for 606. We moved it to 605(b)

14 because of, you know, because part of the

15 information was classified confidential. We

16 then were removing from an agricultural

17 product down to a synthetic material or an

18 ingredient.

19 So that's why we chose to move it

20 there. I do appreciate you coming and

21 clarifying that for us, because that does

22 help. I think most of our Subcommittee would
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1 have, at the time we were deliberating on it,

2 which we still are, would have voted in favor

3 of it, if we could have felt comfortable

4 enough to classify it as a non-synthetic.

5 So I think you have helped clear

6 it up a little bit, for at least some of us. 

7 So thank you.

8 MS. TRINKER: No, you're welcome,

9 and on the record, in the interest of

10 transparency, we can provide more information

11 on that process. And I apologize. It was my

12 understanding that the discussion and the

13 petition would be subject to review. So

14 that's my fault. I thought that discussion

15 and the petition was sufficient.

16 And there's just one other point

17 too, that I thought the Technical Report did

18 not list any of the new studies done in

19 infants since the EFSA decision in 2008. 

20 They're in the petition. They show favorable

21 impacts in infants, in moderating reactive

22 protein that is a mark of anti-inflammation.
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1 They're also summarized in my

2 statement, and I'd ask that you all look at

3 these and review them carefully.

4 MR. FOSTER: Thank you. Thank you

5 for your time. John. Oh, I'm sorry. Jay,

6 did you have a question?

7 MR. FELDMAN: Yes, I had one more

8 question. Sorry.

9 MR. FOSTER: I'm sorry I didn't

10 see you, Jay.

11 MR. FELDMAN: When you talk about

12 these ingredients, do you have -- are there

13 published levels in the product that are

14 either assumed or -- I mean since we don't

15 have a standard, I don't believe, how does the

16 industry determine the level of these

17 substances that are added, in this case,

18 lutein?

19 MS. TRINKER: The level of the

20 substance, the amount of lutein in infant

21 formula?

22 MR. FELDMAN: Yes.
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1 MS. TRINKER: That's a very good

2 question, and if you look at our petition, we

3 think that there's some safeguards that

4 address your specific point.

5 Lutein, our lutein has gone

6 through the GRAS process, and it cannot be

7 added in infant formula for term infants at

8 levels that exceed 250 micrograms per liter.

9 So by law if we -- and it wouldn't

10 be us; it would be the company, the customer. 

11 So if they were to exceed that, legally the

12 ingredient would no longer be GRAS, and the

13 product would be adulterated. So that's a

14 pretty strong deterrent against excess levels.

15 MR. FOSTER: Thank you.

16 MS. TRINKER: Thank you.

17 MR. FOSTER: Next, I'm showing

18 Helen Kor, followed by Troy Aykan.

19 MS. KOR: My name is Helen Kor. 

20 I'm a nutritionist with the Hain Celestial

21 Group. My company advocates breast feeding as

22 the first and best choice for infant feeding. 
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1 However, for mothers who cannot breast feed,

2 my company offers milk based and soy based

3 organic infant formulas, and the precise

4 formulations reflect the combined knowledge 

5 of the FDA, international regulatory agencies,

6 professional associations, and the leading

7 experts in the field of infant nutrition and

8 health.

9 I am here to support the petitions

10 for the nutrients used in infant formula. I

11 will focus my comments today on the petitions

12 for methionine, carnitine and taurine. But

13 first, I want to correct some misinformation.

14 It has been stated by some

15 commenters that organic soy-based infant

16 formula contains hexane-extracted soy protein

17 isolate. This is not true, because synthetic

18 solvents may not be used in organic

19 ingredients.

20 Organic soy protein isolate is

21 used in our soy-based infant formula and is

22 certified by an accredited certifier under the
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1 NOP.

2 L-methionine is an amino acid that

3 is vital for growth and development of

4 infants. Because soy-based infant formulas do

5 not provide sufficient methionine without

6 fortification, soy-based formulas must be

7 fortified with L-methionine to meet the

8 protein requirements of the FDA. We could not

9 sell or organic soy-based formulas without it.

10 We strongly urge the NOSB to

11 approve the petition to add L-methionine to

12 the National List. L-carnitine is another

13 amino acid that is found in breast milk, and

14 is vital for infant growth and development.

15 An inadequate carnitine intake may

16 result in failure to thrive, low blood sugar

17 and cardiomyopathy. Therefore, carnitine

18 fortification of infant formula is recommended

19 by both the EU and the Life Sciences Research

20 Office, operating under contract with the FDA.

21 Initially, carnitine was only

22 added to soy-based infant formulas, but
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1 starting in the 90's, some milk-based infant

2 formulas began to be fortified, to ensure that

3 they meet the minimum recommended level.

4 We strongly urge the Board to

5 approve the petition for L-carnitine to the

6 National List for both soy-based and milk7 based infant formulas. 

8 Taurine is present in significant

9 amounts in breast milk. Taurine is needed for

10 proper functioning of the retina, for proper

11 digestion and absorption of fats, for heart

12 and motor function and other important

13 physiological functions.

14 Infant formula needs to have added

15 taurine to match the levels in breast milk. 

16 This is why taurine has been added to both

17 milk-based and soy-based infant formulas all

18 over the world for decades. We urge the Board

19 to approve the petition for taurine. 

20 Some of the people opposing the

21 petitions for infant formula nutrients

22 acknowledge that there are no available
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1 substitutes for these nutrients. But their

2 solution, that women should only breast feed,

3 is not feasible, due to physical problems,

4 their jobs and/or upon advice from their

5 health care provider.

6 My son had a slower growth rate

7 than is expected in his first few months of

8 life, and so my pediatrician advised me that

9 my son must be fed infant formula, because

10 breast feeding alone could not provide the

11 calories and nutrients needed for optimum

12 growth and development. This was the best

13 choice for my son.

14 As a nutrition scientist and a

15 mother, every child deserves a formula that

16 delivers adequate nutrients needed for optimal

17 growth and development. I implore this Board

18 to approve all the petitions for nutrients

19 added to organic infant formula. Thank you.

20 MR. FOSTER: Thank you. Do we

21 have any questions for the commenter? Jean,

22 Jay.
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1 MS. RICHARDSON: Thank you for

2 your comments. One of the other public

3 comments that we received in the written

4 material before the meeting included a

5 statement that L-carnitine is required in the

6 European Union, for addition to organic

7 formula.

8 Can you tell me if that's correct

9 from your knowledge in the manufacturing

10 process?

11 MS. KOR: I'm not familiar with

12 the EU regulations. I work for a U.S.-based

13 company. But through my understanding and

14 what was written in the petitions, that is

15 indeed the case, that there is a requirement

16 in the EU for carnitine.

17 MR. FOSTER: Thank you. Jay.

18 MR. FELDMAN: Thank you for your

19 statement, and your clarification on the

20 extraction process for the soy isolate. What

21 is the process? Can you explain the process

22 that is currently used?
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1 MR. FOSTER: I'm not a food

2 scientist, so I don't know the process for

3 extracting --

4 MR. FELDMAN: Somehow we'll get

5 the answer to that by the end of today, I

6 hope. Thanks.

7 MR. FOSTER: I'm sure it can be. 

8 Additional questions? 

9 (No response.)

10 MR. FOSTER: All right. Thank you

11 very much. Next up, Troy Aykan, followed by

12 Zareb Herman.

13 MR. AYKAN: Good morning. My name

14 is Troy Aykan. I'm a food scientist and an

15 attorney, specializing in food laws and

16 regulations, and a professor. One of the

17 questions asked by the NOSB is whether a

18 material is essential for organic production.

19 If a material has been shown to be

20 essential for proper growth and development in

21 infants, then it should be considered

22 essential for infant formula. The Infant
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1 Formula Act was passed in 1980, and a list of

2 nutrients was codified in 21 C.F.R.

3 Some people erroneously believed

4 that if a nutrient or substance is not listed

5 here, it's not essential for infants. This is

6 not correct. This list is not intended to be

7 only ingredients necessary for infant

8 formulas.

9 There have been many advances in

10 nutrition science since 1980, and other

11 ingredients have been introduced to provide

12 nutrition that infants need.

13 Before a non-listed nutrient can

14 be used in infant formula, it must go through

15 a thorough GRAS notification process with the

16 FDA. After it's granted GRAS status, before

17 the nutrient is used, the component must

18 document the benefits of the nutrient to the

19 satisfaction of the FDA.

20 Every infant formula then is

21 supported by clinical trials, and is

22 thoroughly reviewed by FDA before it can be
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1 even sold. It's important to note that many

2 essential nutrients don't even have daily

3 values, such as numerous amino acids, fatty

4 acids and other nutrients.

5 The ingredients in infant formula

6 have nutritional or functional properties that

7 provide for a safe and complete formula. To

8 limit the ingredients to just those nutrients

9 from 1980 will result in an outdated

10 incomplete, unstable nutritionally inferior

11 formula.

12 Consumers expect organic infant

13 formula to be the best formula that they can

14 buy for their babies. To deny the use of

15 these substance will place organic formula at

16 a competitive disadvantage, when compared to

17 non-organic formulas, and more importantly, it

18 will place the health of babies at risk, and

19 could result in the elimination of organic

20 infant formulas altogether.

21 Actions by this Board can have

22 serious consequences. For example, oxidation
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1 of essential fatty acids is a major challenge. 

2 Oxidized or rancid fats smell terrible and can

3 cause serious diarrhea in infants. 

4 If the petition for ascorbyl

5 palmitate is not approved, the shortened shelf

6 life will make infant formula commercially

7 unbuyable. Our products must travel from the

8 production site to our warehouses, then ship

9 to distributor warehouses until orders come

10 in, and then it ships to other warehouses or

11 to the retail stores, which might require

12 shelf lives of up to 15 months.

13 With ascorbyl palmitate, there is

14 a good chance that oxidative destruction of

15 essential fatty acids and vitamins will occur. 

16 This may cause the levels of these nutrients

17 to fall below the levels that are required by

18 federal food laws.

19 Such products could be considered

20 adulterated, due to rancid fats, or

21 misbranded, due to insufficient levels of

22 nutrients. Actions which violate the above-
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1 mentioned laws and regulations may also be a

2 violation of OFPA, which states in relevant

3 part that "nothing in this chapter shall alter

4 the authority of Secretary of Health and Human

5 Services under the federal food laws."

6 If certain nutrient petitions are

7 denied, this will impact international trade. 

8 Without carnitine, we could not sell our

9 formula in the EU. Similarly, without

10 taurine, we could not sell our organic infant

11 formula in Canada, which is a major trading

12 partner.

13 For these reasons, and many more,

14 we urge the Board to approve the petitions for

15 these important nutrients. Thank you. Any

16 questions?

17 MR. FOSTER: Thank you, Mr. Aykan. 

18 Questions? Mac?

19 MR. STONE: You had in bold on the

20 previous slide that it could eliminate organic

21 formulas on the market, but it didn't say it

22 "would." What would you have to do to not
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1 have it eliminate infant formulas?

2 MR. AYKAN: I don't see the

3 gentleman asking the question. Could you

4 repeat it please? I'm sorry.

5 MR. STONE: On the previous slide,

6 you had a bold statement, said it "could"

7 result in the elimination of organic infant --

8 MR. AYKAN: Yes sir.

9 MR. STONE: It doesn't say it

10 "would" eliminate. So what would you have to

11 do to adjust for this, if the Board were to

12 deny any or all of these?

13 MR. AYKAN: Yes, great questions. 

14 There are, with the denial of the petitions,

15 there are two problems, okay. One is

16 oxidation of essential fats. As the previous

17 experts testified, that infant formula

18 contains about 25 to 28 percent fat. 

19 Not just VHA. VHA is a very small

20 portion. But a lot of other fats, because

21 linoleic acid is required by law to be there. 

22 So to protect these fats from oxidation, we
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1 need to have the system of ascorbyl palmitate

2 and tocopherols and beta carotene.

3 If you're asking me what is it

4 that can be done, is that I don't know how

5 science could come up with something, another

6 oxidation system that would be acceptable. 

7 But in any case, as you may realize, we're

8 already selling these formulas. They are

9 available.

10 They're available in the U.S. as

11 organic infant formulas. We sell these in

12 Canada. We started selling them in China and

13 Hong Kong. And to think, of course they have

14 different local regulations.

15 That is of no concern here, but it

16 requires some study and I don't know how soon

17 that could be done. Three years, four years. 

18 I don't know, but these oxidation systems

19 already exist.

20 The second problem would be the

21 lack of important nutrients, such as taurine,

22 carnitine and methionine, which was, you know,
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1 explained in detail by experts.

2 MR. FOSTER: Thank you. Jay. Oh

3 I'm sorry. I thought you -- you have no idea

4 how much I'd love to have you do that. I want

5 to be mindful of time. People are getting

6 hungry. We have a few more speakers. I want

7 to make sure we make sure to get to them. 

8 So choose your questions wisely,

9 that's all. I'm happy to go through it. I

10 just want to make sure we're aware of that. 

11 Nick's promising me very short. Okay, Nick,

12 Jay and --

13 MR. MARAVELL: The question's

14 short.

15 MR. FOSTER: Nick, Jay and Harold.

16 MR. MARAVELL: No. The answer

17 should be short too. You said you're selling

18 your product abroad now, Canada, China and

19 perhaps other markets. With regard to

20 ascorbyl palmitate, it's our understanding

21 it's not permitted under the Canadian standard

22 for organic infant formula.
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1 I'm not familiar with the Chinese

2 situation, and I would -- so I'm asking has

3 that been something that has been brought to

4 your attention with your product, and then the

5 final one is would you anticipate any problems

6 selling your product in Europe? So I'm just

7 trying to get an idea of how that works.

8 MR. AYKAN: Yes. You just

9 switched from Canada to Europe. In Europe,

10 yes, I understand it.

11 MR. MARAVELL: No. It's multiple

12 questions.

13 MR. AYKAN: Yes, I understand it.

14 MR. MARAVELL: I'm a globetrotter,

15 okay.

16 MR. AYKAN: Okay. In Europe

17 obviously, ascorbyl palmitate is approved for

18 use as a proper Vitamin C source, as I looked

19 it up personally myself. As far as the Canada

20 and ascorbyl palmitate, I don't have the

21 answer, but I'll defer to one of my colleagues

22 that may come up after me.
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1 As far as these formulas, and let

2 add this too, is that our organic infant

3 formula is made right there in New England, in

4 Vermont, by Vermont dairies, 100 percent, and

5 locally, and we'd like to keep this business

6 here.

7 As far as the Canadian question, I

8 have to check our formula, to see whether

9 there's an ascorbyl palmitate. That's a

10 really good question to know. Yes, yes, I

11 agree with you.

12 MR. FOSTER: Thank you. I have

13 Jay there.

14 MR. FELDMAN: Thank you. With all

15 the expertise -- John, this is actually a

16 question for you, because I don't know how you

17 want to handle this, with all the expertise in

18 the room and the references to GRAS among many

19 of the commenters.

20 I'm wondering if we could have a

21 definition, both by FDA and maybe Mr. Aykan,

22 on what exactly GRAS means. It's been used. 
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1 We know what it stands for, Generally

2 Recognized as Safe. But this process of FDA

3 granting GRAS status, what exactly does that

4 mean, and does that conform to our standards

5 under OFPA. 

6 So if we could use the expertise

7 in the room, I'd appreciate it.

8 MR. FOSTER: My instinct would be

9 going to our guest from the FDA, would be my

10 sense. Does that sound reasonable?

11 MR. FELDMAN: Cool.

12 MR. FOSTER: Okay. Then I had

13 Harold, I believe, had a question.

14 MR. AUSTIN: Just quickly. In

15 regards to taurine, you mentioned that without

16 it, you could not, your formula could not go

17 into Canada? Could you clarify that, or did

18 I mis-hear what you were saying?

19 MR. AYKAN: Yes sir. Taurine is

20 required in Canada, so it must be added to the

21 Canadian formula, and also -- that's my

22 understanding. Yes, just been confirmed. It
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1 is required, and I want you to please also

2 understand that if possible, you know, we'd

3 like to use the same formula for our friends

4 in Canada and here, if possible, obviously.

5 But because as you guys know,

6 there's a certain organic equivalency

7 agreements and all that stuff. But yes,

8 taurine is required in Canada, yes.

9 MR. AUSTIN: Thank you.

10 MR. AYKAN: Mandatory.

11 MR. FOSTER: Follow-up, Harold? 

12 One more quick one.

13 MR. AUSTIN: Would you happen to

14 know the regulations that are guiding the

15 nutrients required in Canada, how current

16 those are, when those were established, versus

17 1980 for ours, or 1985?

18 MR. AYKAN: My, the answer is that

19 I do not know. My thinking is that they are

20 more recent, but by the day is over, we could

21 give you a report on that as to the date, as

22 information. But I don't have it in front of
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1 me.

2 MR. FOSTER: I'm sure that

3 someone's Googling it right now. All right. 

4 No more questions? Thank you very much for

5 your time. Next up, thank you, thank you. 

6 Next up, I see Zareb Herman, followed by David

7 Cockram.

8 MR. HERMAN: My name is Zareb

9 Herman. I'm a nutritionist with the Hain

10 Celestial Group. I am here to support the

11 petitions for the nutrients used in organic

12 infant formula, because these ingredients are

13 found in breast milk and the science supports

14 their importance for infant growth and

15 development.

16 When the Infant Formula Act was

17 passed in 1980, I was living in Berkeley,

18 California. My graduate advisor was one of

19 the leading experts in maternal and infant

20 nutrition. In the last 30 years, nutritional

21 science has advanced greatly. 

22 Infant formula manufacturers have
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1 a tremendous responsibility to provide the

2 most current and best possible nutrition for

3 infants during the most crucial stages of

4 their development. When it comes to what is

5 necessary in infant formula, we need to trust

6 the infant formula experts.

7 I prepared a handout for the

8 Board. I don't know if they received it, but

9 I don't have time to go into it. But I would

10 ask you to look at it, because it sort of

11 condenses what would happen if you took each

12 nutrient out of infant formula.

13 And also on the handout, I show

14 this particular slide, and it shows the

15 continuum of views on non-organic ingredients

16 in processed organic foods. On the far right

17 are the people who say heck, add anything you

18 want.

19 On the far left are people who say

20 organic foods should have only organic

21 ingredients, nothing else, no National List. 

22 In the middle are people who support a
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1 reasonable National List. They support

2 necessary non-organic ingredients in processed

3 organic foods such as infant formula.

4 It is important to remember that

5 over 50 percent of the organic market is

6 processed food. The vast majority of these

7 products require some non-organic ingredients. 

8 Without them, these products could not exist. 

9 Consumers want organic infant formula. 

10 I know this, because organic

11 infant formula is a major portion of the

12 organic foods market, with annual sales of

13 $500 million. Many organic farmers and many

14 other people make their living because of

15 organic formula.

16 A no vote on these petitions will

17 almost certainly wipe out organic infant

18 formula from the marketplace. The organic

19 regulations provide for the use of synthetic

20 ingredients when necessary. This is why we

21 have Section 605(b) of the National List. 

22 We don't live in a perfect world. 
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1 The reality is that some nutrients are only

2 available in synthetic form. They are

3 identical to the molecules in breast milk. 

4 Being synthetic does not make them evil. The

5 rejection of a substance just because it is

6 synthetic is not valid.

7 Some people who oppose these

8 petitions argue that there are substitutes

9 that can be used. However, these substitutes

10 must actually exist, and they must work and be

11 available to be considered viable

12 alternatives. 

13 Some people want to keep the

14 National List small. They kind of lean to the

15 left a little. I want to remind that these

16 petitions are not for all organic foods. The

17 petitions are for a small but very important

18 group, with special dietary needs, infants.

19 We all need to stand back from the

20 politics and ask what is really important

21 here. The answer is the health of babies. We

22 should all want what is best for babies, and
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1 not sacrifice their health by denying them

2 these nutrients.

3 Lastly, I'm not trying to be funny

4 when I say this, but please, don't throw the

5 baby out with the bath water. 

6 MR. FOSTER: Thank you. Questions

7 for Zareb?

8 (No response.)

9 MR. FOSTER: Thank you very much. 

10 Next up I see David Cockram, followed by

11 Robert Rankin.

12 DR. COCKRAM: Hi. My name's David

13 Cockram. I'm representing Abbott Nutrition,

14 makers of Similac organic infant formula. I'm

15 a nutrition scientist and a registered

16 dietician. Have had over 25 years of

17 experience developing infant formulas and

18 adult nutritional products for people with a

19 variety of conditions.

20 Breast feeding is clearly the

21 number one option, the best option for nursing

22 infants in the first year of life, but it
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1 isn't always possible or chosen. An infant

2 formula that complies with the Infant Formula

3 Act's requirements for composition, pre-market

4 notification, quality and documented safety is

5 the only appropriate substitute for human

6 milk.

7 The compositional requirements, as

8 you've heard in the Infant Formula Act

9 represents minimum standards for infant

10 formula. However, the Infant Formula Act

11 nutrients have not been updated since the

12 1980's, and I would suggest to you nutrition

13 knowledge has grown, and the Infant Formula

14 Act nutrients no longer fully reflect

15 contemporary nutrition knowledge.

16 Lutein and lycopene are good

17 examples of this. The dietary guidelines for

18 Americans, which have incidentally been

19 updated six times since the Infant Formula Act

20 nutrients were established, encourage us to

21 make half your plate fruits and vegetables,

22 and to eat red, orange and dark green
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1 vegetables.

2 The dark colors in these foods are

3 the result of the carotenoid content. 

4 Carotenoids are a collective term for, as

5 you've heard, for a number of structurally6 related compounds.

7 Some, like lutein and lycopene,

8 are the focus of very intense research

9 efforts, and there's throwing recognition of

10 the role of these substances in human

11 nutrition, especially infant nutrition.

12 I'm going to focus on lutein, but

13 the story is fairly similar for lycopene as

14 well. Diets contain over 50 carotenoids, of

15 which about 20 can be found in the blood. Of

16 these, they are highly concentrated in certain

17 tissues, those being the eye, that bright

18 yellow spot there in the eye, is primarily

19 lutein, and then in the centers of the brain

20 that are associated with learning, memory and

21 vision.

22 Carotenoids are transferred from
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1 mom's diet to the infant via breast milk. 

2 Early breast milk or colostrum has a very high

3 lutein content, which decreases over time and 

4 in breast-fed infants, blood lutein normally

5 rises over the first month of life, something

6 as you see on the right doesn't tap into

7 infant-fed formula without supplemental

8 lutein.

9 Until infants begin consuming

10 complimentary foods, infants only get

11 carotenoids from fortified formulas. Studies

12 now in both term and pre-term infants show

13 that lutein levels approximate those in human

14 milk-fed infants when supplemented formulas

15 are fed, but not when unsupplemented formulas

16 are fed.

17 The brain grows very rapidly, as

18 we've heard, in the first six months of life. 

19 This shows relative development of neural

20 pathways in the visual cortex of the brain,

21 and as noted earlier, lutein is highly

22 concentrated in this part of the brain.
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1 Evidence from a recent study in

2 premature infants suggests that lutein

3 accumulation early in life may be

4 physiologically important.

5 These are data from premature

6 infants fed a carotenoid-supplemented formula,

7 and showed signs of improved neural retinal

8 health or eye health, based on a sophisticated

9 measure, rod photo-receptor sensitivity, which

10 highlights the role and potential benefit of

11 lutein in infant formula. I'll stop.

12 MR. FOSTER: Thank you. Question

13 for the commenter? The best four minutes of

14 your life, huh?

15 DR. COCKRAM: I'm sorry?

16 MR. FOSTER: Fastest four minutes

17 of your life.

18 DR. COCKRAM: It was a fast four

19 minutes. Can I volunteer the answer to the

20 question of the difference between soy protein

21 isolate and concentrate?

22 MR. FOSTER: Yes.
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1 DR. COCKRAM: Since 18 people have

2 asked and nobody's really answered?

3 MR. FOSTER: And you're willing to

4 answer it. Go for it.

5 DR. COCKRAM: Basically, the

6 difference is the concentration of protein. 

7 I can't speak to the details of the

8 manufacturing, because I don't know. But soy

9 protein isolate usually has a higher

10 concentration of protein, less fats,

11 carbohydrates, minerals with it. 

12 Soy protein concentrate is

13 generally a little bit lower, is lower and

14 it's over a range of protein concentrations. 

15 But the tradeoff is with a concentrate, you

16 tend to have more of the other stuff from soy

17 that's still there, the minerals, the

18 electrolytes, etcetera.

19 MR. FOSTER: Thank you. Okay,

20 Jay.

21 MR. FELDMAN: Well, just to follow

22 up. Thank you for asking yourself that
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1 question. I guess the question is what is

2 typically used in the industry. I mean

3 somebody is --

4 DR. COCKRAM: In terms of the

5 concentrate versus isolate?

6 MR. FELDMAN: In soy --

7 DR. COCKRAM: I can't speak to

8 that. We don't use that for -- I mean it's

9 isolate in infant formulas for certain. 

10 MR. FOSTER: Thank you for your

11 time.

12 MS. SONNABEND: I have a question.

13 MR. FOSTER: Oh, I'm sorry. I'm

14 sorry. David, would you come back? Zea.

15 MS. SONNABEND: Your company

16 manufactures infant formula, not the

17 components of the infant formula; right?

18 DR. COCKRAM: You are correct.

19 MS. SONNABEND: Okay. To your

20 knowledge, are there more than one company

21 that make lutein and lycopene and those types

22 of products?
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1 DR. COCKRAM: There are several

2 manufacturers of lutein in particular, as well

3 as lycopene. To my knowledge, there is only

4 form that has been reviewed by FDA for infant

5 formula use, and I guess that kind of gets me

6 to the point I had up on the slide, or that I

7 didn't get to, was other sources certainly

8 have ingredients. 

9 Could be developed, but the issue

10 is it just takes a very long time, and it's a

11 fairly painful process to do that. Goes

12 through the, you know, two sequential FDA

13 reviews for ingredient safety, the GRAS part,

14 and then clinical or the appropriateness for

15 infant formula. 

16 MR. FOSTER: Thank you. I have a

17 question from Jean.

18 MS. RICHARDSON: We've heard from

19 the commenters that many of these ingredients,

20 if not most of them, are considered by the

21 producers of the formula to be essential for

22 the infant, and yet they're not required by
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1 FDA.

2 As you're pointing out on this

3 slide here, that the infant formulas are

4 highly regulated and closely scrutinized. So

5 we have the challenge sitting here, deciding

6 what to do with it. Why are they not required

7 if they're so darned essential? Could you

8 help us with that?

9 DR. COCKRAM: That's a good

10 question, and I guess one that on occasion

11 I've even debated a bit with Dr. Anderson. 

12 But you know, frankly, the FDA -- in order for

13 FDA to or actually any regulatory body, and I

14 would submit to you this is probably a good

15 thing, in order for any regulatory agency to

16 change a regulation, it's a fairly cumbersome

17 process and requires a lot of work.

18 Goes through notice and comment

19 rulemaking, gets input from all sides, just

20 like we're getting here today, and you know,

21 it's a major chore for the regulatory agency

22 to go through that.
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1 And you know, there are a lot of

2 priorities and under the current regulations,

3 there's really nothing that absolutely forces

4 a manufacturer to limit themselves to -- well

5 obviously there's nothing that forces a

6 manufacturer to limit themselves to only the

7 IFA nutrients.

8 You are obligated to go to FDA and

9 convince them that in fact you will be doing

10 no harm and hopefully some good, and you know,

11 at this point, that system has worked

12 reasonably well with FDA and, you know, Dr.

13 Anderson certainly can comment further on

14 that.

15 But I think we have, you know, I

16 think because of the burden of changing

17 regulations, you know, certainly public health

18 guidelines and recommend, you know, the

19 recommendations for nutrient intake have

20 changed over time. But the regulations,

21 probably as a good thing, haven't.

22 MR. FOSTER: Thank you. Just to
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1 follow up on that Jean, my hope is that

2 shortly, the Handling Committee will come back

3 from lunch.

4 We go, according to the agenda, to

5 an immediate Handling Subcommittee break, and

6 so we have -- we will need to get with Dr.

7 Anderson, I believe no later than 1:30, in

8 order to make sure she can leave on her

9 schedule. 

10 So my hope is that Handling

11 Subcommittee can get back -- at least Handling

12 Subcommittee can get back by 1:30, so that we

13 have time to take advantage of Dr. Anderson's

14 knowledge with respect to the GRAS question

15 perhaps Jean, as well as the question you just

16 asked, and the rosemary extract.

17 Any -- okay, thank you for your

18 time.

19 DR. COCKRAM: Thank you.

20 MR. FOSTER: Next up, I have

21 Robert Rankin and then the last speaker

22 scheduled is Marsha Walker.
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1 MR. RANKIN: Good morning. My

2 name is Robert Rankin. I am the Associate

3 Director of the International Formula Council. 

4 The IFC is an association of manufacturers and

5 marketers of formulated nutrition products,

6 including infant formulas, and we appreciate

7 the opportunity to speak today.

8 I would like to thank the NOSB and

9 the NOP for your hard work on these

10 activities. These are a lot of difficult

11 decisions you will need to make. As has been

12 stated today, and we didn't make it any easier

13 with our petitions that we submitted.

14 However, I think it makes an

15 important point, in terms of what has been

16 discussed today, related to what we knew in

17 1980 versus what we know today. So I'll be

18 speaking about that in a second.

19 As stated in our petitions and

20 written comments, the ISC supports the

21 continued use of all nutrients in organic

22 infant formula. They have been reviewed and
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1 accepted by the U.S. FDA and regulatory

2 agencies around the world for use in infant

3 formula, and with the exception of ascorbyl

4 palmitate, they're all found in human breast

5 milk.

6 Because there were so many

7 petitions and so many nutrients to discuss, I

8 will not be commenting on each one

9 individually. Instead, I'll be providing some

10 contextual comments, which I hope will help

11 the NOSB in your evaluations.

12 First, the ISC supports the

13 American Academy of Pediatrics'

14 recommendations regarding breast feeding. 

15 Human milk is the gold standard for infant

16 nutrition, and provides specific maternal and

17 infant benefits.

18 The ISC also supports positive

19 efforts to support and promote breast feeding. 

20 Every mother should breast feed if she can and

21 chooses to do so. The reality is not all

22 mothers can and want to breast feed. There
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1 are a variety of reasons for it, be it

2 maternal health, infant health, adoption, lack

3 of workplace support, cultural reasons, a

4 mother's choice and many others.

5 The NOSB was not created, nor are

6 we here to discuss how infants should be fed. 

7 What we believe we should be discussing is how

8 to ensure infants who are not breast fed

9 receive the most complete, optimal nutrition

10 possible.

11 As has been said before, U.S.

12 regulations define infants as persons no more

13 than 12 months old. Infants are a very

14 critical population, and require specific

15 nutrients to ensure proper growth and

16 development, and these needs are met through

17 breast milk, infant formula, or a combination

18 of both.

19 U.S. regulations also define

20 infant formula as a food solely for infant

21 use, as a complete or partial substitute for

22 human milk. Infant formula is the most highly
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1 regulated food in the world, and is recognized

2 as the only appropriate alternative in meeting

3 the nutritional needs of infants, of mothers

4 who cannot or choose not to breast feed.

5 It is important that infant

6 formula be as nutritionally complete as

7 possible, to ensure proper growth and

8 development.

9 Because infant formula is the sole

10 source of nutrition for many infants,

11 academicians and industry researchers

12 recognize the importance of continuously

13 conducting scientific research, and evaluating

14 results, to ensure and constantly improve the

15 nutritional quality and performance of infant

16 formulas.

17 The primary goal of the infant

18 formula industry is to ensure that infants who

19 are fed infant formula receive a product that

20 is nutritionally close as possible to human

21 breast milk. This requires research and

22 investigation into the composition of human
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1 milk, as well as the mechanisms of the

2 benefits associated with breast feeding.

3 When existing data and new

4 research provide a reasonable basis to

5 conclude that a new ingredient is safe and

6 provides a benefit, the manufacturers are

7 required, as has been said, to provide FDA

8 with documentation of that information, to

9 establish its safety and suitability.

10 It can take decades of academic

11 and industry research to result in a

12 nationally or internationally adopted

13 requirement for a particular nutrient. So

14 while it would be nice to be able to do that

15 on an as-needed basis, it's not practical and

16 feasible, as has been discussed.

17 So that brings me to the

18 discussion being had here today, where it's

19 been suggested that infant formulas may only

20 need to include ingredients listed in the

21 Infant Formula Act from 30 years ago.

22 The Infant Formula Act reflects
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1 the nutrition science known at that time, and

2 over the past 30 years, significant

3 improvements have been made in learning about

4 infant nutrition and the composition and

5 benefits of breast milk, which has resulted in

6 the products you see today. So I'd like for

7 you to take that into consideration as well. 

8 Thank you very much.

9 MR. FOSTER: Thank you. Questions

10 from the Board? Calvin.

11 MR. WALKER: How does the -- if by

12 chance these particular materials are voted

13 down, what kind of impact would that affect

14 your particular business?

15 MR. RANKIN: Well, I'd probably

16 want to refer that to the manufacturers who

17 use the ingredients and manufacture the

18 products. However, I can volunteer a couple

19 of opinions. 

20 Obviously, a lot of research and

21 development has gone into the ingredients that

22 are currently used in infant formula. As I
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1 said before, they've been reviewed and

2 accepted by the FDA. They've also been

3 accepted by regulatory agencies around the

4 world.

5 So they are safe, they are

6 suitable, and based on the information that is

7 required by manufacturers to submit during the

8 review process, they do show proper growth and

9 development. So those nutrients are

10 researched and proven to be safe and suitable

11 for infants.

12 If any of these ingredients are,

13 especially those which provide a function,

14 such as antioxidant and what have you,

15 manufacturers, if they were no longer allowed

16 to use those ingredients, they would be forced

17 to research and develop alternatives, if those

18 exist.

19 That would require, I think the

20 previous speaker had a table which showed a

21 pretty long time table for what goes into

22 researching, studying alternatives, going
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1 through clinical trials, which is required for

2 infant formulas, to show that the ingredients

3 are safe and suitable.

4 The GRAS approval process, which I

5 think it would be great for FDA to discuss a

6 little bit more, because I believe one of the

7 comments I heard from another commenter, in my

8 opinion it kind of -- in my opinion, it

9 downgraded FDA's role in reviewing these

10 ingredients for their safety and suitability.

11 I really believe that the process

12 is robust and it is working, as far as we're

13 concerned, with regards to infant formulas. 

14 But then so the manufacturers would need to

15 identify alternatives, determine that they are

16 suitable, determine that they are viable, and 

17 then determine if that's something that they

18 want to pursue, in terms of staying in the

19 market.

20 But as I think, as you have heard,

21 there's at least one nutrient for which there

22 is not a suitable alternative. So and I think
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1 that affects the antioxidant properties. So

2 that as some have said, could potentially

3 affect the category, although I can't speak to

4 that, because I'm not a manufacturer.

5 MR. FOSTER: Thank you. 

6 Additional questions? Nick and then Zea.

7 MR. MARAVELL: Yes. I was

8 wondering if you have a feel for what

9 percentage of infant formula currently sold in

10 the United States is labeled as organic, and

11 if you had a feeling for how much of that is

12 soy-based and milk-based?

13 MR. RANKIN: I actually don't have

14 information on the percentage of organic

15 infant formula. I think the manufacturers

16 might have an idea, because they would produce

17 those.

18 I would like to say, though, that

19 in my opinion and in my history, my wife buys

20 a lot of organic products and my understanding

21 is that those who are interested in organic

22 products are very passionate about having that
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1 option.

2 And so I think if you get into a

3 situation where the organic option is not as

4 nutritionally complete, perhaps, as a

5 conventional formula, then they may deselect

6 that product and go with an alternative that

7 is not safe and nutritious and recommended,

8 such as a home-made type of product.

9 And that, I think the FDA would

10 agree and the AAP, is definitely not where we

11 want to go with that. Breast milk and infant

12 formula are the two safe nutritious

13 recommended options, and it's my opinion that

14 that option of an organic product for those

15 consumers, and mothers who want to provide

16 that for their infants, should be preserved.

17 Then as far as soy, again Dr.

18 Bhatia made some comments about the needs for

19 soy formula, and I don't disagree with his

20 comments. But I would like to say that with

21 regards to soy, just like with organic and

22 with everything else the consumers have the
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1 opportunity to purchase, we believe that that

2 option should remain available to consumers,

3 because it is an important category for those

4 who want to provide their families with

5 vegetarian options.

6 So we strongly believe that soy

7 formula has its place and it's very important.

8 MR. FOSTER: Thank you. Last

9 question, Zea.

10 MS. SONNABEND: Thank you. In

11 looking at alternatives, particularly to the

12 ascorbyl palmitate and beta carotene, which

13 appear to be preservatives, we're wondering if

14 any of your members or colleagues have looked

15 into the possibility of refrigerated infant

16 formula without preservatives?

17 MR. RANKIN: One of the speakers

18 mentioned that they weren't aware of any

19 research that's been done. You might ask the

20 other manufacturers. But I'm not aware of it

21 myself. Just it's apparently not the way that

22 it has ever been done, and so it's not been
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1 considered, and I know if the AAP would have

2 any comments on that either.

3 MS. SONNABEND: A follow-up to

4 that. Would -- you were talking about you

5 need to go GRAS approval if you're adding

6 other ingredients. But if you were just

7 making refrigerated formula without

8 ingredients, would that still need certain FDA

9 or GRAS approvals?

10 MR. RANKIN: As long as it doesn't

11 include an ingredient that has never been used

12 before and never been reviewed. That GRAS

13 review is for any nutrient that's not

14 considered, you know, on the regulatory list,

15 and has not been used before.

16 So it would need to go through

17 that GRAS approval process. So a short

18 answer, if it's a new ingredient, yes, it

19 needs to go through the GRAS process.

20 MS. SONNABEND: Refrigeration

21 isn't an ingredient, so it's just a process or

22 a product?
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1 MR. RANKIN: Right. If you're

2 talking about taking out ingredients, I think

3 that would be considered a new formulation. 

4 So that would need to go through the FDA

5 approval process again. But as long as there

6 were no new ingredients, it would not need to

7 go through the GRAS review process, just the

8 pre-market notification process.

9 MR. FOSTER: Thank you for

10 clarifying. We have one more speaker,

11 according to my schedule.

12 MR. RANKIN: Thank you.

13 MR. FOSTER: Thank you very much

14 for your time. I had Marsha Walker. Is

15 Marsha in the house? Okay. Marsha's not

16 here. That concludes the public comment that

17 I have on the schedule here.

18 At this point, I need a lot of

19 clarification on the timing of the breaks,

20 because the agenda I have is not clear to me. 

21 So I'm going to need help. I want to make

22 sure that we accommodate Dr. Anderson's
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1 departure schedule. 

2 So I know we need to be back to

3 ask some questions of her by 1:30. But beyond

4 that, help me understand what's in the agenda. 

5 When does everyone need to be back, versus

6 when does the Handling Committee need to be

7 back, because there appear to be a difference

8 in the agenda I have.

9 I'm going to hand this over to --

10 yes, go ahead. I'm listening.

11 CHAIRMAN FLAMM: Well, will it

12 meet our guest's time table if we returned on

13 the scheduled time of 1:30, John. We're

14 almost there right now, so it would be just a

15 little over an hour break. 

16 MR. FOSTER: Okay, returning at

17 1:30.

18 CHAIRMAN FLAMM: And then you'll

19 have the opportunity to get together with your

20 Subcommittee after we have the chance to ask

21 some more questions. Is that okay?

22 MR. FOSTER: That's fine. So back
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1 at 1:30, everyone.

2 CHAIRMAN FLAMM: We'll take a

3 break now for lunch, and be back here at 1:30.

4 (Whereupon, the above-entitled

5 matter went off the record at 12:23 p.m. and

6 resumed at 1:43 p.m.)

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22
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1 A F T E R N O O N S E S S I O N

2 1:43 p.m.

3 MR. FOSTER: All right. Thanks

4 everybody for coming back. I hope you got

5 some provender to keep you going for the rest

6 of the afternoon. We are moving back into the

7 portion of the agenda that's dealing with

8 Handling Subcommittee activities.

9 We had scheduled on the agenda to

10 go directly into additional subcommittee

11 deliberations, which I know the gallery would

12 find fascinating. But instead, we want to

13 accommodate some travel schedules for Dr.

14 Anderson.

15 So with -- Barry, with your okay,

16 I'd rather move straight into the Board

17 members' ability to ask some specific

18 questions of Dr. Anderson. Is that all right

19 with you? Okay. Thank you, Barry. Thank

20 you, Mr. Chairman, I should say.

21 We have a number of questions that

22 came up in the context of earlier dialogue,
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1 that we want to reiterate. Jay, I know you

2 have a question about GRAS notifications. 

3 Jean, I know rosemary extract is one and oh,

4 it looks like I am buying someone's round

5 tonight. There you go. That's me. That's my

6 fault. That was me. I'll claim it.

7 We had a couple of additional

8 questions that came up in the context of a

9 very unofficial lunch, a fast-paced lunch

10 meeting. So we'd like to move straight into

11 questions of Dr. Anderson and others, if we

12 need to. 

13 So with that, Zea I know you had a

14 specific question, and if it's okay with

15 everyone, I'll go Zea, Jay and then Jean, and

16 then take other questions from the Board.

17 MS. SONNABEND: Thank you. Dr.

18 Anderson, my question is following up on what

19 one of the commenters said about going through

20 the FDA process, to get approval for a

21 refrigerated version of an infant formula that

22 did not have preservatives.
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1 Could you describe what that would

2 involve? If it didn't have a new added

3 ingredients, but it was just for

4 refrigeration. 

5 DR. ANDERSON: That would involve

6 a new processing entirely, and the safety of

7 that processing would have to be evaluated. 

8 It would also have to be evaluated for the

9 microbiological quality, the nutrient quality,

10 and they would have to provide an infant

11 formula notification before they go to market,

12 and they would have to show that they were

13 complying with good manufacturing practices,

14 that they were not producing product that

15 could be considered contaminated or

16 adulterated, and that it would support normal

17 growth in infants and be well-tolerated.

18 So they would have to give us an

19 infant formula notification, to give us

20 assurances that the product was being produced

21 in a way that is following good manufacturing

22 practices, and that will meet the needs, the
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1 nutritional needs and the safety needs of the

2 infant.

3 One thing we do not approve, these

4 notifications. Congress did not give us

5 approval authority. If an infant formula

6 company comes to us and gives us a

7 notification, they have to do so 90 days

8 before they go to market.

9 But on the 90th day, they are free

10 to go to market, even if we have serious

11 questions about the product. Congress didn't

12 give us approval authority.

13 MS. SONNABEND: Dr. Bhatia, could

14 you address that question?

15 DR. BHATIA: I have a more

16 practical point. Let me, if you take sterile

17 formula, with a long shelf life, what have

18 you. I'm not here representing anybody who

19 manufactures, and open that can or bottle or

20 refrigerate it, you have to throw it away in

21 48 hours.

22 So if you only have non-
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1 preservative, refrigerated milk, not only are

2 you reducing shelf life; then you have to

3 prove that the formula, as prepared, is good

4 in the refrigerator, even for that 48 hour

5 period. So it has got a lot of implications

6 and one simple step.

7 MR. FOSTER: Jay.

8 MR. FELDMAN: Thank you. Dr.

9 Anderson, thank you. The earlier question I

10 had was about the standards for FDA, and the

11 actual process that the FDA goes through when

12 a manufacturer lists as GRAS.

13 DR. ANDERSON: Okay. As indicated

14 earlier, GRAS stands for Generally Recognized

15 as Safe, and that's a category of food

16 ingredient. There are two categories of food

17 ingredients. One is food additives, and that

18 has to have food additive status. A compound

19 has to be petitioned to the agency.

20 The agency approves or not

21 approves the petition, and a regulatory

22 decision is made and that has the force of
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1 law. For a Generally Recognized as Safe

2 substance, the agency provides a different

3 mechanisms for establishing the Generally

4 Recognized as Safe status, and I should

5 emphasize that the -- it's not the substance

6 that has GRAS status; it's the substance for

7 its intended use that has the GRAS status.

8 So if it's for use in infant

9 formula, that's the use that has to be

10 evaluated in any evaluation of safety.

11 The process that is used for

12 evaluation of Generally Recognized as Safe

13 Ingredients by the Office of Food Additive

14 Safety is a voluntary process, in which infant

15 formula manufacturers, food manufacturers,

16 ingredient manufacturers come to the agency

17 and say that we have self-determined that this

18 substance is GRAS for use in infant formula or

19 whatever, and we base this on either history

20 of use or scientific substantiation,

21 scientific evidence, and in addition, it's

22 recognized in the scientific community by
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1 experts qualified by training and experience,

2 that this is indeed a use that is safe for the

3 particular substance.

4 Now with the provision of a GRAS

5 notice, the information all has to be publicly

6 available. The agency cannot consider

7 proprietary or confidential data as primary

8 evidence for the safety of the compound for

9 that particular use, and the agency does not

10 make its own determination of the safety.

11 At the end of the review of that

12 notice, the agency will issue a letter saying

13 either we have no questions of your self14 determination, or we do have questions and

15 these are what the questions are.

16 So it is incumbent on the

17 manufacturer to provide the, for the safe use

18 of the ingredients in their products. Neither

19 the infant formula notification process, which

20 is mandatory, nor the GRAS notice process,

21 which is voluntary, are approval processes.

22 And so that in a nutshell is what
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1 we, what the process is for new food

2 ingredients for infant formula.

3 MR. FOSTER: Thank you. Follow4 up, Jay?

5 MR. FELDMAN: Yes, thanks. I

6 actually had another question after that, but

7 is part of the assessment, it sounds like

8 there's an assessment in there somewhere. In

9 other words, the company or institution is

10 self-certifying, subjecting their information

11 to some review process at FDA by somebody or

12 some panel of people, and then they get a

13 letter of some sort. Is that accurate? Am I

14 summarizing that accurately?

15 DR. ANDERSON: Pretty much so. As

16 you've said, FDA does not make its own

17 independent review of all the data on its own. 

18 FDA relies on the information that's provided

19 in the GRAS notice, and other information

20 that's available in the publicly available

21 literature.

22 MR. FELDMAN: Okay.
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1 DR. ANDERSON: If there's issues

2 that they have questions about, they

3 communicate those questions to the notifier

4 during the review, and they can provide

5 supplemental information. However, it's not

6 an independent review of the safety of the use

7 of a particular substance.

8 MR. FELDMAN: Okay, and just one

9 other thing on that point. As a part of the

10 information that is submitted to FDA, does any

11 of that information include data or other

12 types of information on the manufacturing

13 processes that are used to produce this?

14 DR. ANDERSON: Oh yes. Yes, it

15 does. It includes information on the

16 composition of the substance, on the

17 manufacturing process, on any toxicological

18 tests that have been done, any clinical tests

19 that have been done, any scientific

20 information that's available on the substance,

21 and I think that pretty much sums it up. 

22 MR. FELDMAN: Okay, thank you,
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1 thank you. John, I have another question if

2 there's time.

3 MR. FOSTER: Okay, yes. We'll go

4 to Jean and then round back if we have time. 

5 Thank you, Jay. Jean.

6 MS. RICHARDSON: Yes, I have two

7 questions. The first question relates to the

8 use of rosemary as a potential antioxidant in

9 infant formula. Do you know if rosemary

10 extract -- some of the technical report

11 information suggested that rosemary extract

12 could be permitted as an antioxidant, and if

13 it is used, does it have any other use that

14 you're aware of?

15 DR. ANDERSON: The only use that

16 I'm aware of for rosemary extract is as a

17 flavoring agent. I'm not aware that it's ever

18 been used in infant formula as an antioxidant. 

19 FDA has certainly never evaluated that use for

20 safety.

21 Addition of a new antioxidant

22 system in infant formula would require a pre-
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1 market notification for the new infant

2 formula, and in our review of that infant

3 formula notification, we would want to be

4 certain of the scientific basis of the safety

5 for that use of rosemary extract, or any other

6 new antioxidant system in infant formula.

7 Like I said, rosemary extract is

8 generally recognized as safe for use as a

9 flavor, in accordance with good manufacturing

10 practice in FDA's regulations. Whenever we

11 get an infant formula notification that might

12 involve use of a new ingredient, we consult

13 with the Office of Food Additive Safety, which

14 is responsible for the review of GRAS

15 notifications and has the expertise on

16 evaluating food safety, ingredient safety

17 questions.

18 We always encourage infant formula

19 manufacturers to submit a food additive

20 petition or a GRAS notice to the Office of

21 Food Additive Safety, and to work with that

22 office to resolve any safety issues about use
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1 of ingredients new to infant formula, before

2 they come to us with an infant formula

3 notification.

4 Just one additional word here, is

5 that the time line for review of a GRAS notice

6 is 180 days. The time line for review of an

7 infant formula notification is 90 days. So if

8 an infant formula manufacturer comes to us

9 with a GRAS notice for, I'm sorry, with an

10 infant formula notification, for which they

11 haven't resolved safety issues of a new

12 ingredient, then that really creates problems

13 getting a review or consulting with the Office

14 of Food Additive Safety on an accelerated time

15 line.

16 MS. RICHARDSON: Thank you. My

17 second question relates to essentiality. As

18 you know, we have to try to determine if

19 anything that's going into the infant formula,

20 is it essential for that formulation, for that

21 product.

22 We know that these items that
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1 we're looking at today are not required by the

2 FDA at the present time, but as you heard from

3 the presentations this morning, they are

4 stated, many of them, as being essential for

5 the formula to make a whole food for that

6 infant.

7 So could you help us to understand

8 why if they are indeed essential, why are they

9 not on your -- on the FDA list?

10 DR. ANDERSON: The term "required"

11 is a legal term that's used in our regulations

12 and in the law, to indicate the 29 nutrients

13 that are required in infant formula. The term

14 "essential" is used by the nutrition community

15 to recognize that substances are needed in the

16 diet of humans.

17 The Institute of Medicine of the

18 National Academy of Sciences is an

19 authoritative body that provides information

20 on the essential, on what are essential

21 nutrients. Like I said earlier, it requires

22 a formal rulemaking procedure, which is very
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1 long and involved and complicated, to change

2 a regulation.

3 For us to change or update the

4 list of 29 required nutrients and their

5 minimum values would require that formal

6 rulemaking process. However, in another part

7 of the infant formula regulations, there is

8 allowance for addition of other substances in

9 infant formulas.

10 For example, selenium has -- in

11 the time between 1985 and now, selenium was

12 recognized as an essential mineral. It has

13 not been added to the list of 29, and

14 primarily because of agency priorities and the 

15 cumbersomeness of rulemaking.

16 However, infant formula

17 manufacturers do add selenium to their

18 products, and they are -- the do so on the

19 basis that the National Academy has found it

20 to be essential in human nutrition. So I hope 

21 that answers your question. 

22 We don't -- although we have a
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1 list of 29 required nutrients, we don't have

2 a list of mandatory ingredients or a

3 restricted list of ingredients that can be

4 added to infant formula.

5 MS. RICHARDSON: Are you aware

6 then if the National Academy has said that any

7 of these ingredients we're looking at today

8 are essential?

9 DR. ANDERSON: No. The-- no.

10 MR. FOSTER: All right. Are there

11 questions from others on the Board? I have

12 one. I think -- I don't think it will be a

13 long one; then we can get back to others. 

14 What, in this GRAS notification process, what

15 happens if an operator were to, you know, give

16 you this notification and you've got 180 days

17 to respond to them.

18 What happens if they've provided

19 some information to you that's incorrect or

20 inconsistent with guidelines or standards ore 

21 requirements? What can happen them in the

22 context of infant formula, where they've just
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1 misreported something?

2 Like if they're trying to pull the

3 wool over your eyes, what happens when you

4 catch them doing that?

5 DR. ANDERSON: If there are safety

6 issues involved, it would be regarded as an

7 adulterated product, and there would be

8 compliance issues with that, and so -- and

9 there could be -- it would be a prohibited act

10 to market that, and there are criminal

11 penalties involved with that.

12 MR. FOSTER: And so what's the

13 consequence to the supplier of that

14 information, if you find something out that

15 they were trying to hide, or if something was

16 bad, something was wrong? So what compliance? 

17 What do you mean by compliance action? 

18 What happens? Does that mean show

19 up at their house or --

20 DR. ANDERSON: Well, a warning

21 letter could be issued. Product could be

22 seized, an injunction could be issued.
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1 MR. FOSTER: That's what I was

2 looking for. Thank you. Questions from

3 others on the Board?

4 DR. BHATIA: It also appears on a

5 FDA warning list.

6 MR. FOSTER: I'm sorry, what

7 appears on a warning list?

8 DR. BHATIA: Not FDA, but when

9 some of these infractions occur, FDA issues a

10 warning that is public domain. So that actual

11 list which is kept forever, saying so and so

12 has manufactured X and Y. So there's an

13 actual warning published to the public domain

14 about any infraction which the FDA is against.

15 MR. FOSTER: The old version of

16 shunning back in the day. Thank you for that. 

17 Questions from others on the Board for either

18 of our guests? Then we'll go back to Jay for

19 a last one.

20 MR. FELDMAN: Okay. So this is a

21 question about the levels, the nutrient levels

22 that would be allowed in these products. I
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1 assume whether it's organic or not, the levels

2 that would be used would be uniform across

3 conventional and organic products.

4 But if FDA is not setting a level

5 as required or essential, because somebody

6 else does that, where do these levels, these

7 nutrient levels that actually end up in the

8 final product come from? Who makes the

9 determination as to whether the levels are the

10 right levels, or that they, somehow children

11 are being over-exposed or there's a risk

12 factor there that's not being considered

13 fully?

14 DR. BHATIA: Well, it's

15 interesting you ask that question, because

16 right now the NIH has convened a body. NIH,

17 FDA, USDA, AAP, all these different people, to

18 ask that very question. What are the

19 questions from 0 to 24 months which would

20 include the period you're talking about, the

21 infant formula would be the key question.

22 A lot of the requirements at not
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1 known. These are best estimates made from

2 epidemiology, are the classic nutrition

3 principles of defining a requirement. So

4 either you find a population that was

5 sufficient, or you find a population that had

6 excess, or you find a population that's

7 deficient, and you guess that it is somewhere

8 between the deficient and the excess. 

9 Then a best guess is made. That's

10 one way of looking at nutrients. So we really

11 don't have evidence, informed guidelines for

12 every nutrient that's already there, and

13 that's where the struggle is now, to put

14 together some body of evidence which says this

15 is a human requirement. This has been a

16 slippery slope.

17 DR. ANDERSON: And I can add to

18 that as well. In the GRAS notification, in

19 the GRAS notice process, one of the elements

20 that's required, and I neglected to mention,

21 is that there has to be an exposure estimate,

22 of exposure of -- what the exposure will be,
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1 and why that exposure will be safe, and there

2 --

3 In each GRAS notification, there

4 is an upper limit that is specified for the

5 exposure, and that that exposure will be safe.

6 MR. FELDMAN: But again, that is

7 not independently reviewed by FDA, as to

8 whether in fact that level is either effective

9 or potentially problematic?

10 DR. ANDERSON: Yes. FDA does not

11 do its own independent review. However, all

12 of those decisions or all of those no further

13 questions are time-dependent, and if any

14 information becomes available after that

15 letter is issued, FDA would reconsider any

16 updated information.

17 MR. FELDMAN: Thank you.

18 MR. FOSTER: Mac, I saw your hand.

19 MR. STONE: I have one question in

20 reference to rancidity. We heard about the

21 oxidation and rancidity of the oils. If you

22 have -- who determines that shelf life, and if
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1 in fact it is a food safety issue? Does the

2 manufacturer determine the date that it should

3 be removed from the shelf, or does anybody

4 verify the preservative value or that length

5 of shelf life?

6 DR. BHATIA: I can't get too

7 technical on this, but I can tell you from my

8 own what the shelf life means. The shelf life

9 specifies that the nutrients on the label, the

10 minimum amounts of nutrients on the label are

11 still present at the end of shelf life.

12 The other issues of being rancid,

13 coloring, all that, that's determined way

14 before the formula is even submitted to the

15 FDA for review. In fact, if you go to any of

16 the manufacturing places, a lot of people from

17 Abbott can confirm what I'm saying, the whole

18 shelves, there are whole shelves of formula

19 that are kept for time to see what happens to

20 formula over time.

21 But that claim is only based on

22 that the formula will have the minimal amounts
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1 of nutrients specified in the label. So as a

2 matter of fact, each manufacturer adds much

3 more than the minimal level to assure minimum

4 label is still there one year later.

5 This is especially true for

6 vitamins, which are photo-sensitive and decay

7 over time. 

8 MR. FOSTER: All right. I had

9 Nick there, but it seems he's out for a sec. 

10 I'll ask for others. Jean, did you get what

11 you need? Okay. All right. I'm assuming Dr.

12 Anderson had to leave; clearly she did.

13 But I'm assuming she had to leave

14 the premises actually, to catch her next

15 appointment. So with that, if there's no more

16 questions, we'll move into a 15 minute break

17 for the Handling Subcommittee, to get our

18 heads together, see what changes, if any, we

19 need to make and then reconvene at -- let's

20 make it 2:25 as a full board. Thanks.

21 Oh, I'm sorry. Thank you Dr.

22 Bhatia. Thank you for being here. Thank you
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1 for your -- we found, actually we talked about

2 this at lunch. This was very valuable to have

3 you here, and we'll be recommending to the

4 program that we have more regular interactions

5 like this during our Board meetings.

6 So I thank you for that, for

7 setting an excellent precedent. It was very,

8 very helpful to have you here. So thank you

9 very, very much.

10 DR. BHATIA: Thank you for the

11 kind comments, and appreciate the invitation.

12 MR. FOSTER: Thank you.

13 (Whereupon, the above-entitled

14 matter went off the record at 2:10 p.m. and

15 resumed at 2:36 p.m.)

16 MR. FOSTER: Barry, I'm handing

17 the virtual gavel back to you. 

18 CHAIRMAN FLAMM: Thank you, John,

19 and I believe we're ready to proceed. The

20 Handling Committee is ready to vote on all of

21 its proposed -- shh, shh, shh. Can't hear

22 myself think. 
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1 The Handling Committee is ready to

2 proceed on all their petition materials,

3 except for nucleotides, which is being

4 postponed until tomorrow. I think the voting

5 will proceed in the same order that it was

6 presented this morning, and so I'll entertain

7 a motion on the first material, and that is --

8 MR. FOSTER: The first item is

9 ascorbyl palmitate. Nick, I believe you have

10 the goods on that. 

11 MR. MARAVELL: Where am I?

12 MR. FOSTER: Ascorbyl palmitate. 

13 MR. MARAVELL: Are we entertaining

14 motions?

15 MR. FOSTER: We are accepting

16 motions about the petition to add ascorbyl

17 palmitate to the National List.

18 CHAIRMAN FLAMM: But we need the

19 motion.

20 MR. MARAVELL: The first motion

21 would be a listing, a classification motion?

22 CHAIRMAN FLAMM: That is correct.
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1 MR. MARAVELL: Okay. So I am

2 willing, I am going to make a motion that

3 ascorbyl palmitate is synthetic. 

4 CHAIRMAN FLAMM: Do we have a

5 second?

6 MS. FULWIDER: I second that.

7 CHAIRMAN FLAMM: We have a motion

8 that's been seconded to classify ascorbyl

9 palmitate, CAS No. 137-66-6 as synthetic. 

10 Discussion?

11 (No response.)

12 CHAIRMAN FLAMM: Hearing none,

13 I'll proceed with the vote. The vote will

14 begin with Jean.

15 MS. RICHARDSON: Yes.

16 MR. WALKER: Yes.

17 MR. BONDERA: Yes.

18 MS. TAYLOR: Yes.

19 MR. MARAVELL: Yes.

20 MR. FELDMAN: Yes.

21 MS. SONNABEND: Yes.

22 MR. STONE: Yes sir.
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1 MS. FULWIDER: Yes.

2 MR. AUSTIN: Yes.

3 MS. FAVRE: Yes.

4 MS. BECK: Yes.

5 MR. FOSTER: Yes.

6 MR. DICKSON: Yes.

7 CHAIRMAN FLAMM: And the chair

8 votes yes. We have 15 yes, 0 no's. The

9 motion to classify the material as synthetic

10 passes. I'm going to entertain a motion to

11 list. 

12 (Off record comments.)

13 CHAIRMAN FLAMM: So we can

14 entertain a motion on listing the material.

15 MR. MARAVELL: I'd like to make a

16 very brief clarification and then go forward

17 with the motion. In the materials prepared by

18 the Subcommittee on Ascorbyl Palmitate, we did

19 reference the fact that rosemary extract was

20 something that this Board had approved with

21 regard to DHA and ARA, which was for use in

22 infant formula. 
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1 In a private conversation with Dr.

2 Anderson, I asked how that came about, given

3 that FDA has never reviewed rosemary extract,

4 and she had a very straightforward and simple

5 answer. What we approved was not what Martech

6 had submitted to FDA for their GRAS listing.

7 And so indeed, our statement is

8 correct, but it would lead one to believe that

9 perhaps rosemary extract had also been in some

10 way reviewed or submitted to FDA, and that is

11 not the case. On behalf of the Committee, I

12 apologize if we misled anybody, even though

13 our statement is technically correct.

14 Now I'll proceed with a motion. I

15 make a motion to add ascorbyl palmitate, CAS

16 No. 137-66-6 to the National List, Section

17 205.605(b) for use as a preservative in infant

18 formula.

19 MS. RICHARDSON: I second that

20 motion.

21 CHAIRMAN FLAMM: Who seconded it?

22 MS. FULWIDER: Jean.
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1 CHAIRMAN FLAMM: Jean seconded the

2 motion. We have a motion, which has been

3 seconded, to add ascorbyl palmitate, CAS No.

4 137-66-6 to the National List, Section

5 205.605(b) for use as a preservative in infant

6 formula. Discussion? Zea.

7 MS. SONNABEND: Thank you. For

8 the purposes of everyone in the audience, and

9 so that everyone is clear on this point, I

10 would like to ask the NOP to state what would

11 happen if something that has previously been

12 allowed in infant formula comes off the list,

13 because we don't vote for it at this time. 

14 Could you just say what people can expect from

15 that?

16 MS. BAILEY: Thanks, Zea. So as

17 people are well aware, the Department

18 published a proposed rule in January of this

19 year, with a proposal to amend the listing for

20 nutrient vitamins and minerals on the National

21 List, and we proposed what new language would

22 be.
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1 That new language would not

2 provide for the use of the nutrients that are

3 petitioned before you today. So in September,

4 we published an interim rule to continue the

5 listing as it is currently codified in the

6 regulations, which essentially maintains the

7 status quo.

8 We are taking comments on that

9 interim rule for 90 days until December 26th. 

10 In the proposed rule, we explicitly asked for

11 input from commenters on the proposed length

12 of the compliance period, which would have

13 been two years after the issuance of any final

14 rule on the matter.

15 So at this point, the interim rule

16 maintains the status quo. We have not issued

17 a final rule, based on the comments that say

18 what the intention of the agency is as far as

19 a compliance period. But we did ask for those

20 comments and would address any comments about

21 compliance in any final rule that we would do.

22 CHAIRMAN FLAMM: Follow-up?
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1 MS. SONNABEND: Well, I have one

2 additional clarification. For these

3 particular first two items that are able to be

4 used as vitamins in the proposed rule that

5 already is out, the vitamin, ascorbyl

6 palmitate is a source of Vitamin C and beta

7 carotene is a source of Vitamin A.

8 If we are not voting for them

9 here, that means they can still be used as the

10 source of Vitamin A or Vitamin C, because what

11 we are doing is voting them off for the

12 petition use as a preservative.

13 MR. FELDMAN: And can you verify

14 that -- I'm sorry. 

15 CHAIRMAN FLAMM: Jay.

16 MR. FELDMAN: Could you verify the

17 citation under where that fits? Is that just

18 under the general Vitamins and Minerals? 

19 Okay. Okay.

20 CHAIRMAN FLAMM: Nick.

21 MR. MARAVELL: Yes. Just to

22 amplify one point on what Zea said, the
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1 ascorbyl palmitate, which is the motion that

2 we're considering right now, was petitioned as

3 an antioxidant, which functions as a

4 preservative, and Dr. Anderson clarified from

5 her point of view that antioxidants were a

6 subcategory of preservatives. But the actual

7 petition was as an antioxidant. 

8 CHAIRMAN FLAMM: Any further

9 discussion of the material? There's no

10 further discussion, I believe we can proceed

11 with voting, beginning with Calvin.

12 MR. WALKER: No.

13 MR. BONDERA: No.

14 MS. TAYLOR: No.

15 MR. MARAVELL: No.

16 MR. FELDMAN: No.

17 MS. SONNABEND: No.

18 MR. STONE: No sir.

19 CHAIRMAN FLAMM: Wendy?

20 MS. FULWIDER: Yes.

21 MR. AUSTIN: Yes.

22 MS. FAVRE: No.
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1 MS. BECK: Yes.

2 MR. FOSTER: Yes.

3 MR. DICKSON: No.

4 MS. RICHARDSON: No.

5 CHAIRMAN FLAMM: And chair votes

6 no. How many yes's do we have? Four. 4

7 yeses, 11 no's. The petition does not pass. 

8 The motion does not pass. We can proceed for

9 the next material. John, you're just going to

10 make a motion for --

11 MR. FOSTER: We'll hear a motion

12 regarding beta carotene from Tracy.

13 MS. FAVRE: I make a motion to

14 classify beta carotene as petitioned as

15 synthetic.

16 MR. BONDERA: I'll second that.

17 CHAIRMAN FLAMM: We have a motion

18 and it's been seconded, to classify beta

19 carotene as synthetic. Discussion? Tracy.

20 MS. FAVRE: I would just like to

21 reiterate that the same conditions exist for

22 beta carotene, synthetic beta carotene as
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1 petitioned. It is approved for pro Vitamin A

2 use, and it has been -- should we vote this

3 down, it would still be allowed for vitamin

4 use.

5 CHAIRMAN FLAMM: Any other

6 comments?

7 MR. FELDMAN: I'm just -- sorry

8 guys. I'm a little confused on this, because

9 my understanding is that these are not -- if

10 I heard correctly today, neither the Vitamin

11 A or the Vitamin C in these forms are allowed

12 in infant formula. That's what I heard today.

13 So we would not want to give the

14 organic community the impression that we were

15 allowing something in the form of a vitamin

16 through this listing or any other listing that

17 wasn't approved by FDA. So that's just a

18 clarification. I'm probably misinterpreting.

19 CHAIRMAN FLAMM: I think Tracy had

20 her hand up first.

21 MS. FAVRE: Jay, it's my

22 understanding that it is allowed, but it is
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1 not typically chosen for use. Vitamin A

2 isolate was used -- Dr. Anderson remarked that

3 Vitamin A isolate was typically used for

4 Vitamin A in infant formula, rather than beta

5 carotene.

6 CHAIRMAN FLAMM: Nick.

7 MR. MARAVELL: By way of

8 clarification, Jay, that, I would not agree

9 with your statement. What we heard and what

10 was contained in the TR is that ascorbyl

11 palmitate is a source of Vitamin C and is

12 approved as such by FDA for infant formula.

13 However, if you look at practice

14 in the industry, the TR states and Dr.

15 Anderson stated that you would use ascorbic

16 acid, because it -- ascorbyl palmitate, when

17 it enters the body, in order to be Vitamin C,

18 it has to hydrolyze and become, part of it, 

19 ascorbic acid.

20 So why not just put the ascorbic

21 acid in, if you're looking for the Vitamin C

22 action. However, it is permitted to be used
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1 as a source of Vitamin C.

2 MR. FELDMAN: Thanks for that

3 clarification.

4 CHAIRMAN FLAMM: Further

5 discussion?

6 (No response.)

7 CHAIRMAN FLAMM: If not, we can

8 proceed with the voting on the motion to list

9 the material. Beginning with Colehour. 

10 Colehour. 

11 MR. BONDERA: I apologize this is

12 a classification motion, not a listing motion;

13 correct?

14 CHAIRMAN FLAMM: Yes, sorry.

15 MR. BONDERA: I vote yes.

16 MS. TAYLOR: Yes.

17 MR. MARAVELL: Yes.

18 MR. FELDMAN: Yes.

19 MS. SONNABEND: Yes.

20 MR. STONE: Yes sir.

21 MS. FULWIDER: Yes.

22 MR. AUSTIN: Yes.
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1 MS. FAVRE: Yes.

2 MS. BECK: Yes.

3 MR. FOSTER: Yes.

4 MR. DICKSON: Yes.

5 MS. RICHARDSON: Yes.

6 MR. WALKER: Yes.

7 CHAIRMAN FLAMM: And the chair

8 votes yes. 15 yeses, 0 no's. The motion to

9 classify beta carotene is a synthetic passes. 

10 Do we have a motion to list beta carotene?

11 MS. FAVRE: Yes. I'd like to make

12 a motion to add beta carotene as petitioned to

13 205.605(b) for use in infant formula. 

14 CHAIRMAN FLAMM: Do we have a

15 second?

16 MR. FOSTER: Second.

17 CHAIRMAN FLAMM: It's been moved

18 and seconded to add beta carotene as

19 petitioned to 205.605(b) for use in infant

20 formula. Discussion.

21 (No response.)

22 CHAIRMAN FLAMM: I guess we
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1 already had so much discussion on this, under

2 the synthetic part that I almost forgot. I

3 believe then we can proceed with the voting,

4 beginning with Jennifer.

5 MS. TAYLOR: No.

6 MR. MARAVELL: No.

7 MR. FELDMAN: No.

8 MS. SONNABEND: No.

9 MR. STONE: No sir.

10 MS. FULWIDER: No.

11 MR. AUSTIN: No.

12 MS. FAVRE: No.

13 MS. BECK: No.

14 MR. FOSTER: Yes.

15 MR. DICKSON: No.

16 MS. RICHARDSON: No.

17 MR. WALKER: No.

18 MR. BONDERA: No.

19 CHAIRMAN FLAMM: And the chair

20 votes no. 1 yes and 14 no's. The motion to

21 list beta carotene fails. So what's next,

22 John?
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1 MR. FOSTER: We will be having a

2 vote on adding lutein to the National List. 

3 Harold.

4 MR. AUSTIN: Okay. I would like

5 to make a slight clarification before we make

6 the motion. After listening to the

7 manufacturers' information and presentation,

8 we went back, the Handling Committee went

9 back, took another look at the TR, because we

10 were on the fringe of deciding whether or not

11 to list this as a synthetic, or to reverse our

12 previous decision.

13 But based off of the information

14 and based off of her presentation, the

15 registrant's presentation, and then going back

16 and revisiting the information, and looking at

17 the process actually is through

18 saponification, estrification and de19 estrification, actually as it's determined by

20 our process, does classify that as a chemical

21 change.

22 So our motion will be to list
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1 lutein as a synthetic.

2 CHAIRMAN FLAMM: Could you restate

3 the motion, Harold?

4 MR. AUSTIN: The motion would be

5 to list lutein, CAS No. 127-40-2, as

6 petitioned, as a synthetic.

7 CHAIRMAN FLAMM: Do we have a

8 second?

9 MS. FULWIDER: I second that

10 motion.

11 CHAIRMAN FLAMM: We have a motion,

12 which has been seconded, to classify lutein as

13 CAS No. 127-40-2, as petitioned, as a

14 synthetic. Discussion.

15 (No response.)

16 CHAIRMAN FLAMM: Would you want to

17 restate what you said previously before the

18 motion was made, Harold, or does anybody feel

19 it necessary to -- are they clear on it? I

20 guess everybody's clear. I guess we can

21 proceed with the vote then. There's no desire

22 for further discussion, so begin with Nick.
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1 MR. MARAVELL: Yes.

2 MR. FELDMAN: Yes.

3 MS. SONNABEND: Yes.

4 MR. STONE: Yes sir.

5 MS. FULWIDER: Yes.

6 MR. AUSTIN: Yes. 

7 MS. FAVRE: Yes.

8 MS. BECK: Yes.

9 MR. FOSTER: Yes.

10 MR. DICKSON: Yes.

11 MS. RICHARDSON: Yes.

12 MR. WALKER: Yes.

13 MR. BONDERA: Yes.

14 MS. TAYLOR: Yes.

15 CHAIRMAN FLAMM: And the chair

16 votes yes. 15 yes, 0 no. Entertain a listing

17 motion on the material.

18 MR. AUSTIN: Okay. The Handling

19 Subcommittee would move to add lutein, CAS No.

20 127-40-2, to the National List, 205.605(b),

21 for use in infant formula only, lutein using

22 approved organic delivery ingredients.
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1 CHAIRMAN FLAMM: Do we have a

2 second?

3 MS. RICHARDSON: I second the

4 motion.

5 CHAIRMAN FLAMM: Jean seconds the

6 motion, to add lutein, CAS 127-40-2 to the

7 National List of 205.605(b) for use in infant

8 formula only, lutein using approved organic

9 delivery ingredients. Discussion. Jay.

10 MR. FELDMAN: This is a broader

11 discussion. Obviously, you know, we don't want

12 to spend a lot of time on this. But I think

13 I'd start with the premise that organic is

14 held to a higher standard in the marketplace,

15 that the expectation is higher, for better or

16 worse.

17 That's the burden and the

18 challenge that we have, I think, as a

19 community, and this area of accessory

20 nutrients in infant formula is really

21 troubling to me, especially because of the way

22 Dr. Bhatia answered the last question that I
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1 asked.

2 And that is the recognition or the 

3 understanding that a lot of what we're

4 discussing here is really outside the scope of

5 FDA. I mean FDA is in a situation where

6 they're operating under an old statute. They

7 haven't updated their requirements. 

8 Our law talks about requirements,

9 for the most part, and we are then being asked

10 to add materials for which the academic and

11 scientific community have not yet agreed on

12 even what the appropriate levels are of these

13 things including lutein.

14 So I think it's unnecessary to put

15 the organic label in the middle of all of this

16 for soy product at this time, and I view this

17 as protecting the label, so that we can grow

18 acreage, by the way.

19 So I see this as our opportunity

20 to say we are about protecting the label and

21 growing acreage. So I think we have to keep

22 that in mind when we vote on these materials
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1 cross the board, at this stage, given where we

2 are, and given the lack of scientific cohesion

3 on the value of these things, and the long4 term impacts, etcetera. Thank you.

5 CHAIRMAN FLAMM: Further

6 discussion? Zea.

7 MS. SONNABEND: Thank you, Barry. 

8 This one, I would have to say, is the toughest

9 one for me to make a decision on. You know,

10 what we've heard today is how valuable it is

11 to developing infants. But when we look at

12 the extraction process and the manufacturing

13 process, which has finally been disclosed to

14 us, we find that this truly is a plant

15 derivative. It's made from marigolds.

16 The great irony of our little

17 corner of the world here is that the reactions

18 that cause it to come out of the marigolds and

19 become lutein would cause it in our definition

20 of thinking to be synthetic.

21 But if the marigolds were grown

22 organically and treated with other compounds
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1 on the National List, it could be certified

2 organic product. So oddly enough, I'm going

3 to go along with Jay here, and wait for the

4 organic marigolds to get grown, and expand the

5 acreage and vote against it.

6 (Laughter.)

7 CHAIRMAN FLAMM: Well, when we get

8 done laughing, I'll call on John.

9 MR. FOSTER: On that note, I

10 believe I did just see a pig fly right by that

11 window.

12 (Laughter.)

13 MR. FOSTER: Right as Zea was

14 saying that.

15 CHAIRMAN FLAMM: Organic pig?

16 MR. FOSTER: Absolutely, of

17 course. 

18 CHAIRMAN FLAMM: Is that your

19 comment, John?

20 MR. FOSTER: That's it. That's

21 the best I've got right now.

22 (Laughter.)
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1 CHAIRMAN FLAMM: Any other

2 discussion? It doesn't appear we have any

3 more comments. We'll proceed with voting on

4 the motion, beginning with Jay.

5 MR. FELDMAN: No.

6 MS. SONNABEND: No.

7 MR. STONE: No sir.

8 MS. FULWIDER: Yes.

9 MR. AUSTIN: Yes.

10 MS. FAVRE: No.

11 MS. BECK: Yes.

12 MR. FOSTER: Yes.

13 MR. DICKSON: Yes.

14 MS. RICHARDSON: Yes.

15 MR. WALKER: No.

16 MR. BONDERA: No.

17 MS. TAYLOR: No.

18 MR. MARAVELL: No.

19 CHAIRMAN FLAMM: And the chair

20 votes no. I'll have to wait for a tally here. 

21 The vote is 6 yes, 9 no's. The motion to list

22 fails. We have next material, John.
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1 MR. FOSTER: Yes, we do.

2 CHAIRMAN FLAMM: What is it,

3 lycopene.

4 MR. FOSTER: We do. The next

5 material we'll be voting on is lycopene. 

6 Nick, would you go forward?

7 MR. MARAVELL: I make a motion. I

8 move that crystalline lycopene be classified

9 as a synthetic material.

10 MR. BONDERA: I'll second that.

11 CHAIRMAN FLAMM: It's been moved

12 and seconded that lycopene be classified as a

13 synthetic material. Discussion.

14 (No response.)

15 CHAIRMAN FLAMM: Doesn't look like

16 there's need for any further discussion, so we

17 can begin with voting. Zea, you may start the

18 voting.

19 MS. SONNABEND: Yes.

20 MR. STONE: Yes sir.

21 MS. FULWIDER: Yes.

22 MR. AUSTIN: Yes.
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1 MS. FAVRE: Yes.

2 MS. BECK: Yes.

3 MR. FOSTER: Yes.

4 MR. DICKSON: Yes.

5 MS. RICHARDSON: Yes.

6 MR. WALKER: Yes.

7 MR. BONDERA: Yes.

8 MS. TAYLOR: Yes.

9 MR. MARAVELL: Yes.

10 MR. FELDMAN: Yes.

11 CHAIRMAN FLAMM: And the chair

12 votes yes. We have 15 yes and 0 no. So the

13 motion to classify as synthetic passes. Do we

14 have a motion for the lycopene to be listed?

15 MR. MARAVELL: Yes. I move that

16 crystalline lycopene, CAS No. 502-65-8, for

17 use in infant formula be added to the National

18 List, Section 205.605(b). 

19 CHAIRMAN FLAMM: Do we have a

20 second?

21 MR. AUSTIN: Second that.

22 CHAIRMAN FLAMM: Harold seconds. 
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1 The motion that crystalline lycopene, CAS No.

2 502-65-8 for use in infant formula be added to

3 the National List, Section 205.605(b). 

4 Discussion on the motion?

5 (No response.)

6 CHAIRMAN FLAMM: No discussion on

7 the motion? We can proceed with the voting,

8 then, beginning with Mac.

9 MR. STONE: No sir.

10 MS. FULWIDER: No.

11 MR. AUSTIN: No.

12 MS. FAVRE: No.

13 MS. BECK: No.

14 MR. FOSTER: No.

15 MR. DICKSON: No.

16 MS. RICHARDSON: No.

17 MR. WALKER: No.

18 MR. BONDERA: No.

19 MS. TAYLOR: No.

20 MR. MARAVELL: No.

21 MR. FELDMAN: No.

22 MS. SONNABEND: No.
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1 CHAIRMAN FLAMM: And the chair

2 votes no. Do we have any yeses? 0 yes, 15

3 no. The motion fails. Let's see, carnitine. 

4 Next John on the list is, I believe is --

5 MR. MARAVELL: Carnitine.

6 CHAIRMAN FLAMM: Carnitine.

7 MR. MARAVELL: Indeed. Zea, would

8 you go forward with the motion?

9 MS. SONNABEND: I'll make the

10 motion that L-carnitine, CAS No. 541-15-1, as

11 petitioned, is synthetic.

12 CHAIRMAN FLAMM: Is it --

13 MS. FAVRE: I second the motion.

14 CHAIRMAN FLAMM: It's been moved

15 and seconded to classify L-carnitine, CAS No.

16 541-15-1 as petitioned, as synthetic. 

17 Discussion? 

18 (No response.)

19 CHAIRMAN FLAMM: I don't believe

20 there's any desire for further discussions, so

21 we can proceed with the vote, beginning with

22 Wendy.
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1 MS. FULWIDER: Yes.

2 MR. AUSTIN: Yes.

3 MS. FAVRE: Yes.

4 MS. BECK: Yes.

5 MR. FOSTER: Yes.

6 MR. DICKSON: Yes.

7 MS. RICHARDSON: Yes.

8 MR. WALKER: Yes.

9 MR. BONDERA: Yes.

10 MS. TAYLOR: Yes.

11 MR. MARAVELL: Yes.

12 MR. FELDMAN: Yes.

13 MS. SONNABEND: Yes.

14 MR. STONE: Yes sir.

15 CHAIRMAN FLAMM: And the chair

16 votes yes. So 15 yes, 0 no. We can proceed

17 with the motion to list the material. Who

18 wants it?

19 MS. SONNABEND: The motion is to

20 add L-carnitine, CAS No. 541-15-1 to the

21 National List, 205.605(b), for use in infant

22 formula only.
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1 CHAIRMAN FLAMM: Do we have a

2 second?

3 MR. BONDERA: Second that motion.

4 CHAIRMAN FLAMM: It's been moved

5 and seconded to add L-carnitine, CAS No. 541-

6 15-1 to the National List, 205.605(b), for use

7 in infant formula only. Discussion please?

8 (No response.)

9 CHAIRMAN FLAMM: No discussion. 

10 No need for further discussion, so we can

11 begin with the vote, beginning with Harold.

12 MR. AUSTIN: Yes.

13 MS. FAVRE: No.

14 MS. BECK: Yes.

15 MR. FOSTER: Yes.

16 MR. DICKSON: Yes.

17 MS. RICHARDSON: Yes.

18 MR. WALKER: No.

19 MR. BONDERA: No.

20 MS. TAYLOR: No.

21 MR. MARAVELL: No.

22 MR. FELDMAN: No.
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1 MS. SONNABEND: No.

2 MR. STONE: No sir.

3 CHAIRMAN FLAMM: And the chair

4 votes no. I'm sorry, I did that again.

5 MS. FULWIDER: Okay, yes. 

6 CHAIRMAN FLAMM: And the chair

7 votes no. Let's see, 6 yeses and 9 no's. 6

8 yeses, 9 no's. The motion to list fails. 

9 Next material is --

10 MR. FOSTER: L-methionine.

11 CHAIRMAN FLAMM: L-methionine, I

12 believe.

13 MR. FOSTER: We have a motion for

14 you. Tracy, would you be so kind?

15 MS. FULWIDER: Make a motion to

16 list L-methionine on 205.605(b) as synthetic,

17 non-agricultural. 

18 CHAIRMAN FLAMM: Do we have a

19 second?

20 MR. FOSTER: I'll second. 

21 CHAIRMAN FLAMM: We have a motion

22 that's been seconded, to list L-methionine as
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1 synthetic. Is there discussion? Question or

2 --

3 MS. BRINES: Just a clarification

4 from the program. It seemed like it was a

5 combined classification and listing, from the

6 wording of the motion. I just want to be

7 clear. The classification motion is first. 

8 Thanks.

9 CHAIRMAN FLAMM: All right. We're

10 just doing the --

11 MR. MARAVELL: I would agree. 

12 CHAIRMAN FLAMM: Restate it.

13 MS. FAVRE: If I'd just strike the

14 words "non-agricultural," is that sufficient? 

15 Is that what the complaint, the comment is?

16 MR. MARAVELL: No, I think the

17 word "list."

18 MS. FAVRE: Oh, I'm sorry, yes. 

19 Make a --

20 MR. MARAVELL: Motion to classify.

21 MS. FAVRE: Yes, got it.

22 CHAIRMAN FLAMM: Oh, I get it.
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1 MR. MARAVELL: I think we just

2 used the wrong word.

3 MS. FAVRE: Got it, got it, sorry. 

4 I make a motion to classify L-methionine as

5 synthetic. Thank you.

6 CHAIRMAN FLAMM: Thank you. I

7 didn't notice it either. 

8 MR. AUSTIN: I'll second that one.

9 CHAIRMAN FLAMM: I think I said it

10 right, but I didn't read it right. Okay. 

11 Where are we now?

12 So I'll restate the motion for, to

13 make sure it's clear, that the motion is to

14 classify, I mean yes, to classify L-methionine

15 on 205.605(b) as synthetic, non-agricultural. 

16 We don't need the non --

17 MS. FAVRE: The motion is to list

18 L-methionine as synthetic, period.

19 CHAIRMAN FLAMM: As synthetic,

20 period, okay.

21 MS. BRINES: Did you guys say

22 "list" again?
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1 (Laughter.)

2 MS. FAVRE: I make a motion that I

3 need a cup of coffee before I make any more

4 motions.

5 MR. AUSTIN: I'll second that.

6 CHAIRMAN FLAMM: And I need a new

7 pair of glasses.

8 MR. MARAVELL: I want one of Zea's

9 apples.

10 MS. FAVRE: I make a motion that

11 L-methionine is synthetic.

12 CHAIRMAN FLAMM: To classify it.

13 MS. FAVRE: The classify it as

14 synthetic. I'm scared to death to say

15 anything else.

16 CHAIRMAN FLAMM: Okay. Is there a

17 second?

18 MR. FOSTER: Yes, second.

19 CHAIRMAN FLAMM: Okay. It's been

20 moved and seconded to classify L-methionine on

21 205.605(b) as synthetic. Discussion, Zea.

22 MS. SONNABEND: I'd like to
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1 suggest that L-methionine as petitioned, there

2 are non-synthetic forms of L-methionine. So

3 L-methionine as petitioned is synthetic.

4 MS. FAVRE: I would accept that

5 friendly amendment.

6 MR. BONDERA: Excuse me, Mr.

7 Chair. 

8 CHAIRMAN FLAMM: All right. 

9 MR. BONDERA: I suggest that you

10 have the motions that are on the table

11 withdrawn before they're added to at this

12 point in time.

13 CHAIRMAN FLAMM: I think that

14 would be --

15 MR. BONDERA: Because we have a

16 number of motions on the table at this moment.

17 CHAIRMAN FLAMM: I think that

18 probably would be wise, just to clear the

19 slate. Could you do that, Tracy, and then

20 we'll start all over again. I'm sorry for the

21 confusion. Withdraw your motion.

22 MS. FAVRE: I withdraw my multiple
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1 goofy motions.

2 CHAIRMAN FLAMM: We're getting

3 tired, I think. Okay. Would you like to --

4 will you agree to it being removed and we'll

5 start over?

6 MR. FOSTER: I withdraw all my

7 seconds, except the one for her and coffee. 

8 But yes I do, all of them. They're all gone.

9 CHAIRMAN FLAMM: Okay. Let's

10 start over, Tracy.

11 MS. FAVRE: I make a motion to

12 classify L-methionine as petitioned as

13 synthetic.

14 CHAIRMAN FLAMM: And okay. Got

15 it? Is that good, Zea? Okay. Do we have a

16 second?

17 MR. FOSTER: I will second that.

18 CHAIRMAN FLAMM: And John is

19 seconding, and I'll re-read it again for the

20 record. Okay. The motion is to classify L21 methionine on 205.605(b) as petitioned, as

22 synthetic, and this has been seconded. Do we
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1 have any discussion? Sorry for the mix-ups. 

2 (No response.)

3 CHAIRMAN FLAMM: No discussion

4 now? Got it all cleared. So we can begin the

5 voting with you, Tracy. 

6 MS. FAVRE: Yes.

7 MS. BECK: Yes.

8 MR. FOSTER: Yes.

9 MR. DICKSON: Yes.

10 MS. RICHARDSON: Yes.

11 MR. WALKER: Yes.

12 MR. BONDERA: Yes.

13 MS. TAYLOR: Yes.

14 MR. MARAVELL: Yes.

15 MR. FELDMAN: Yes.

16 MS. SONNABEND: Yes.

17 MR. STONE: Yes sir.

18 MS. FULWIDER: Yes.

19 MR. AUSTIN: Yes.

20 CHAIRMAN FLAMM: And the chair

21 votes yes. So it's 15 yes, 0 no's, to

22 classify L-methionine as synthetic, as
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1 petitioned as synthetic. We can now proceed

2 with the motion to list. 

3 MR. FOSTER: The next one up is

4 going to be in the same order we did it

5 before, will be -- sorry, listing motion. 

6 Back to Tracy.

7 MS. FAVRE: I make a motion to

8 list L-methionine for inclusion on 205.605(b),

9 for use in infant formula made with soy-based

10 protein. Excuse me. L-methionine, as

11 petitioned, for inclusion in 205.605(b) for

12 use in infant formula made with soy-based

13 protein.

14 MS. FULWIDER: I second that

15 motion.

16 CHAIRMAN FLAMM: Who seconded?

17 Okay. We have a motion that's been seconded,

18 to list L-methionine, as petitioned, for

19 inclusion on 205.605(b), for use only in

20 infant formula made with isolated soy-based

21 protein.

22 MR. FELDMAN: We took isolated
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1 out.

2 CHAIRMAN FLAMM: Oh that's, sorry. 

3 Just soy-based protein? Yes, okay. 

4 Correction. I'll re-read it. Motion to list

5 L-methionine, as petitioned, for inclusion on

6 205.605(b), for use only in infant formula

7 made with soy-based protein. Is that right? 

8 Okay. That's a motion. Discussion on this

9 motion? No discussion? Zea.

10 MS. SONNABEND: Thank you. 

11 Because this is the one of the group that is

12 truly mandated by the FDA for soy formula,

13 much as I hate to do anything to encourage

14 anyone to use soy formula, I feel like I have

15 to vote for this, because if anyone did use

16 soy formula, I wouldn't want the babies to get

17 an incomplete protein.

18 This one, unlike L-carnitine,

19 cannot be made once they have -- in the

20 digestive system, once they have enough of

21 something else. 

22 CHAIRMAN FLAMM: Colehour, please. 
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1 I'm sorry, were you finished? 

2 MR. BONDERA: Yes, you can go

3 ahead, Jay.

4 CHAIRMAN FLAMM: Colehour?

5 MR. BONDERA: Yes, thank you. 

6 Just in terms of clear understanding, like you

7 just stated Zea, since FDA requires, since

8 it's not a choice; therefore, the conclusory

9 part of your clause isn't accurate, because

10 there never would be a soy formula sold

11 without it. It just wouldn't be organic. 

12 It's not that someone's going to

13 be able to buy one, because it's required. So

14 there couldn't be one without it. So

15 therefore, it's not as if any customers are

16 ever going to purchase one that doesn't have,

17 because it's never going to exist that way. 

18 It's just not going to be organic. 

19 That's the differentiation. Just the way that

20 it came across to me, the way you said it is

21 that --

22 MS. SONNABEND: Conventional, soy-
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1 based formula has to have L-methionine too. 

2 You could not buy any without it.

3 MR. BONDERA: Right. That is

4 what you said, and the way you said it is that

5 you didn't want people to be buying it

6 without. Well, they're not going to ever be

7 able to, which is the first part of what you

8 said.

9 MS. SONNABEND: I think you

10 misunderstood it. I don't want people to ever

11 buy soy formula.

12 MR. BONDERA: I understand that

13 too. You said that. That's true. That was

14 the very first part of what you said. But in

15 any case, thank you.

16 CHAIRMAN FLAMM: Jay.

17 MR. FELDMAN: Thank you. So this

18 is a little complicated for me, and I wish we

19 had more time to sort through this. First of

20 all, as far as I can tell from reading the

21 literature, when we're talking about soy-based

22 formula, we're talking about isolated soy-
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1 based formula. If someone can help me with

2 that, and tell me that's really not the case,

3 I'd appreciate it.

4 But unless we can distinguish here

5 what we're talking about, I think we do a

6 disservice, again, to the organic community,

7 which is held to a higher standard in the

8 marketplace than the conventional side.

9 So I recognize that -- I take this

10 deletion of the word that was in the original

11 listing motion that came out of the

12 Subcommittee as an indication that there's

13 some awareness that there might be a problem

14 with isolated soy-based protein, both in the

15 way it's extracted and because of its reliance

16 on the addition of other synthetic materials,

17 to deliver product that is considered adequate

18 for the infant.

19 Whatever the reason is, I think we

20 should share that with the full Board, why the

21 term was removed from the original listing

22 motion, and I would like to get some technical
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1 support, if the chair thinks that's

2 appropriate, on some of the underlying issues

3 associated with the extraction of isolate soy

4 protein and what that means to an organic

5 product, whether in fact we, as a Board, feel

6 that that base product meets the standard that

7 we are charged with enforcing under the law.

8 So again, sort of a request for

9 assistance here.

10 CHAIRMAN FLAMM: Let me take

11 Tracy's question. I'll get back to you, Jay. 

12 Tracy?

13 MS. FAVRE: Actually, it's not a

14 question. Jay, I just wanted to let you know

15 that the motivation behind that was that we

16 had received some information that there are

17 some formulas used for later stage infants

18 that are not isolated soy. They're just

19 concentrated soy protein.

20 Therefore, we didn't want to

21 exclude that from the possibility. Rather, we

22 had specific concerns about the isolated soy
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1 protein.

2 CHAIRMAN FLAMM: And Jay, were you

3 making a request in that statement you made?

4 MR. FELDMAN: Yes. Well, you

5 know, I don't want to hold the Board back. 

6 But I do believe that if we're talking about

7 concentrated soy protein and isolated soy

8 protein in this motion, we need to understand,

9 you know, the differences. 

10 Are they made differently? Are

11 they produced with different extractants? Are

12 there issues around our criteria as it relates

13 to health and safety and so forth. So I don't

14 know if we could get a quick rundown on that

15 from one of our esteemed experts in the

16 audience, or if anybody else feels they need

17 that kind of information to vote on this.

18 You know, at this point, I'd just

19 think, share my thought process with you all. 

20 I think that if -- I understand that without

21 methionine, this product couldn't be marketed

22 as organic. That's essentially what -- I was
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1 asking the chair, I'm sorry, of the Board. 

2 No, no. I was asking the chair, if the chair

3 felt it was appropriate.

4 So do you use what I'm saying? So

5 if that were the case, without that kind of

6 information, I feel that it would be

7 appropriate to not allow, recognizing that it

8 would impact on the market availability of

9 this with the organic label.

10 I understand that it's having that 

11 effect, but I think we have a duty to first

12 ensure that the product to which we're adding 

13 this to meets the standards of the statute.

14 CHAIRMAN FLAMM: Jay, I do think

15 we had experts here this morning that were,

16 that we more or less cleared, could present us

17 with impartial answers to questions, and I

18 don't know. Bringing others, I don't know if

19 you could get the answer in the time we have,

20 since we had that opportunity for several

21 hours this morning.

22 So I'm reluctant to -- I think
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1 unless -- I'll entertain other thoughts, but

2 I don't know we can get what we're asking for. 

3 Zea, do you have a comment?

4 MS. SONNABEND: Yes. Jay is

5 asking for someone with organic expertise. 

6 Our people this morning had a lot of additive

7 expertise, but couldn't explain necessarily

8 how an organic soy formula would be made,

9 whereas either the formulators in the audience

10 or OMRI would perhaps tell how the soy is

11 extracted, or someone like that, to explain

12 how soy could be extracted for organic

13 soybeans, which may be different than

14 conventional soybeans.

15 CHAIRMAN FLAMM: So is there a

16 person that could briefly give that, that's

17 here?

18 MS. SONNABEND: I would recommend

19 Lindsay, if she's in the audience, or

20 Gwendolyn also could do that.

21 CHAIRMAN FLAMM: Lindsay, would

22 you be willing to come forward and -- that's
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1 short notice, I know, and that's -- we'll just

2 --

3 MS. FERNANDEZ-SALVADOR: The other

4 politics that are going on around here. Get

5 out and vote, folks.

6 Okay. So soy protein isolate is

7 -- it is a process extract of soy protein, and

8 from what I understand and the form that OMRI

9 reviewed many, many years ago, the form that

10 we reviewed was being used in a fertilizer,

11 and this conventional soy isolate was

12 extracted using hexane, and then further

13 processed to isolate the protein further and

14 separate it from the carbs and the fats and

15 the fiber, through an acid-based

16 precipitation.

17 However, under organic production,

18 and I'm not privy to confidential business

19 information, so I don't know the exact formula

20 by which you would get an organic soy isolate,

21 but it would likely be either through a water

22 or a certified organic ethanol extraction,
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1 with a citric acid and sodium hydroxide acid.

2 But it would likely be either

3 through a water or a certified organic ethanol

4 extraction, with a citric acid and sodium

5 hydroxide acid-based precipitation. 

6 CHAIRMAN FLAMM: Does that answer

7 your question?

8 MS. FERNANDEZ-SALVADOR: He says

9 I'm on the right track. Without knowing the

10 exact soy isolate, it's hard to say.

11 MR. FELDMAN: Thank you.

12 (Off record comments.)

13 MS. FERNANDEZ-SALVADOR: I don't

14 work for a certifier. I have never seen an

15 organic certified soy isolate manufacturing

16 process.

17 CHAIRMAN FLAMM: Please. Thank

18 you very much, Lindsay. I appreciate you

19 doing this for us.

20 MR. FELDMAN: I have a follow-up

21 question for the Board, or the Committee,

22 Subcommittee.
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1 CHAIRMAN FLAMM: Okay. Any other

2 --

3 MR. FELDMAN: So --

4 CHAIRMAN FLAMM: Thank you

5 Lindsay.

6 MR. FELDMAN: Okay. So that then

7 raises for me the question as to whether we

8 need to annotate the extraction process. If

9 there is an organic way of doing this or one

10 that is viewed as acceptable under organic

11 standards, I know we don't have an extraction

12 policy yet.

13 But there have been a number of

14 votes that have debated the methodology by

15 which we extract, and hopefully will be

16 incorporated into a larger policy at some

17 point.

18 But lacking that policy, it is my

19 preference to try to exclude the volatile

20 synthetics, and it sounds like what Lindsay

21 described did just that. Okay. I take that

22 back, yes. Okay. So we're still dealing with
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1 volatile synthetics when we're talking about

2 extraction. Is that the case? Okay.

3 CHAIRMAN FLAMM: Okay. You can --

4 MR. FELDMAN: Any other comment,

5 discussion? Yes, okay. Lindsay, you can --

6 MS. FERNANDEZ-SALVADOR: Yes,

7 sorry. I just wanted to clarify one thing,

8 because Jay said something and it wasn't what

9 I said. Lindsay Fernandez-Salvador for OMRI. 

10 It's not with the volatile synthetics; it's

11 with certified organic ethanol would be one

12 way of doing it.

13 That's not synthetic. It's

14 volatile, but it's not synthetic. So that's

15 the difference there.

16 MR. FELDMAN: Thank you.

17 CHAIRMAN FLAMM: Thank you for the

18 clarification. Okay. Any other? Jay.

19 MR. FELDMAN: My question for the

20 record is whether in voting this motion, that

21 are we allowing a broad range of processes in

22 its production of the soy isolate, or are we,
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1 because of other limitations, narrowing that

2 extraction process to the one Lindsay

3 described, to the non-synthetic ethanol

4 process?

5 I just want to be -- I just want

6 to clarify that we are indeed, through this

7 listing, narrowing that extraction process.

8 CHAIRMAN FLAMM: Does anybody on

9 the Subcommittee wish to tackle that question? 

10 Zea.

11 MS. SONNABEND: The extraction

12 process is being limited to things which are

13 organically produced or on the National List. 

14 So organic, non-synthetic ethanol or sodium

15 hydroxide, which is on the National List or,

16 if you figured out how to make it with pectin,

17 it would be allowed, because it's on the

18 National List. 

19 Anything, you know, that's the

20 rule. That's the basic thing in the rule, and

21 that is limiting what types of agricultural,

22 organic products can be treated with.
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1 MR. FELDMAN: Thank you for that

2 clarification.

3 CHAIRMAN FLAMM: Thank you. At

4 one point, I saw somebody. Lisa, did you have

5 a question or clarification you wanted to

6 make?

7 MS. BRINES: No. Zea provided the

8 clarification we were looking for. Thank you.

9 CHAIRMAN FLAMM: I'm sorry. Oh,

10 okay. Thank you. All right. Any other

11 discussion, questions on that? Okay. I

12 believe we can proceed with the vote. Yes,

13 and we're on the motion, aren't we? It's been

14 so long. 

15 Okay. We can proceed with the

16 vote on the listing motion, beginning with

17 Carmela.

18 MS. BECK: Yes.

19 MR. FOSTER: Yes.

20 MR. DICKSON: Yes.

21 MS. RICHARDSON: Yes.

22 MR. WALKER: Yes.
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1 MR. BONDERA: No.

2 MS. TAYLOR: No.

3 MR. MARAVELL: Yes.

4 MR. FELDMAN: Yes.

5 MS. SONNABEND: Yes.

6 MR. STONE: Yes, sir.

7 MS. FULWIDER: Yes.

8 MR. AUSTIN: Yes.

9 MS. FAVRE: Yes.

10 CHAIRMAN FLAMM: And the chair

11 votes yes. What's the count? 13 yes, 2 no's. 

12 The motion to list passes, and we're due for

13 a break, but I suggest we just continue and

14 finish these materials. Is that all right,

15 John, with you?

16 MR. FOSTER: It's okay with me.

17 CHAIRMAN FLAMM: Okay. I believe

18 the next proposal is taurine. 

19 MR. FOSTER: It is indeed taurine,

20 and Jean, would you, do you have a motion?

21 MS. RICHARDSON: Yes. I make the

22 motion to, the classification motion for
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1 taurine, CAS 107-35-7, as petitioned, is

2 synthetic.

3 MR. BONDERA: I'll second that

4 motion.

5 CHAIRMAN FLAMM: Okay. We have a

6 motion which has been seconded, to -- let's

7 see. We've got a motion on taurine, CAS No.

8 107-35-7, as petitioned, to classify it as

9 synthetic. I can't quite read that. Right. 

10 Discussion?

11 (No response.)

12 CHAIRMAN FLAMM: Doesn't appear to

13 be any discussion, so we're going to vote on

14 the motion to classify taurine as synthetic. 

15 I believe we're beginning with John.

16 MR. FOSTER: Yes.

17 MR. DICKSON: Yes.

18 MS. RICHARDSON: Yes.

19 MR. WALKER: Yes.

20 MR. BONDERA: Yes.

21 MS. TAYLOR: Yes.

22 MR. MARAVELL: Yes.
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1 MR. FELDMAN: Yes.

2 MS. SONNABEND: Yes.

3 MR. STONE: Yes, sir.

4 MS. FULWIDER: Yes.

5 MR. AUSTIN: Yes.

6 MS. FAVRE: Yes.

7 MS. BECK: Yes.

8 CHAIRMAN FLAMM: And the chair

9 votes yes. I believe we have 15 yes, 0 no. 

10 You know, to classify taurine as synthetic. 

11 We can proceed with a motion to list taurine. 

12 MS. RICHARDSON: I make a motion,

13 a listing motion, to add taurine, CAS 107-35-

14 7, to the National List 205.605(b) for use in

15 infant formula only.

16 CHAIRMAN FLAMM: We have a motion,

17 which has been seconded, to add to taurine,

18 CAS No. 107-35-7 to the National List,

19 205.605(b) for use in infant formula only. 

20 Can we have discuss on this motion?

21 MS. FAVRE: I second the motion.

22 CHAIRMAN FLAMM: You second the
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1 motion. Thank you, Tracy. It was seconded. 

2 Discussion on the motion?

3 (No response.)

4 CHAIRMAN FLAMM: No discussion on

5 the motion. We can proceed, then, with a vote

6 on the motion, beginning with Joe.

7 MR. DICKSON: Yes.

8 MS. RICHARDSON: No.

9 MR. WALKER: No.

10 MR. BONDERA: No.

11 MS. TAYLOR: No.

12 MR. MARAVELL: No.

13 MR. FELDMAN: No.

14 MS. SONNABEND: No.

15 MR. STONE: No, sir.

16 MS. FULWIDER: No.

17 MR. AUSTIN: No.

18 MS. FAVRE: No.

19 MS. BECK: No.

20 MR. FOSTER: No.

21 MR. DICKSON: No.

22 MS. RICHARDSON: No.
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1 CHAIRMAN FLAMM: And the chair

2 votes no. We have but 1 yes, 14 no's. The

3 motion to list taurine fails. I believe that

4 completes what you were prepared to vote on

5 today, and so we can take a break and be back

6 here in 15 minutes.

7 (Whereupon, the above-entitled

8 matter went off the record at 3:41 p.m., and

9 resumed at 3:56 p.m.)

10 CHAIRMAN FLAMM: Board members,

11 please return to your seats. We're running

12 behind. The next and last session for today

13 is for the Policy Development Subcommittee to

14 present their proposals, and I will turn the

15 gavel symbolically over to Colehour to

16 proceed. 

17 MR. BONDERA: Thank you. Thank

18 you, Mr. Chair. Sorry my microphone is being

19 funny. Very good. If Michelle, you could put

20 up -- no, sorry. It's a little confusing. We

21 have a couple of different PowerPoints in our

22 hands over there.
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1 So I'm going to just go through

2 briefly the Policy Development Subcommittee

3 generally and our topics, and then we'll be

4 trading back and forth among three of our

5 members. At that time, the first thing I'll

6 talk about, and whether or not it's up there,

7 it'll be up there in a minute, is really what

8 we do.

9 We're providing guidance,

10 clarification or proposed standards of NOSB

11 operations, policies, and procedures. We're

12 maintaining the content and updates to the

13 NOSB policy and procedure manual and the new

14 member guide, and we're working with other

15 Subcommittees to develop joint proposed

16 recommendations, where policy issues are

17 involved.

18 So it looks like I'm just going to

19 read to you rather than you seeing as well,

20 the other part of that slide, which is the

21 members. The members are myself, Joe Dickson,

22 Jay Feldman, Barry Flamm, Jean Richardson, Mac
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1 Stone, Jennifer Taylor, and C. Reuben Walker.

2 So we have, and again I apologize

3 that they're not up on the screen, but we have

4 three proposed recommendations, and we will be

5 hearing about them in that order. Thank you. 

6 Sorry, thank you. It's all good.

7 There they are. Conflict of

8 Interest or COI, Public Comment and Public

9 Communications. So you know, this is just the

10 background reality and actually, I presented

11 this, a version of this same slide that's up

12 there right now at our previous meeting.

13 But I think that, you know, I

14 think it's worth reiterating the fact that

15 these topics came up because of a combination 

16 of requests from the NOP, from the public and

17 from within the NOSB for reviewing and

18 updating the policy procedure manual.

19 And the updated reality is the

20 fact that the conflict of interest was put

21 forth at both the Savannah, Georgia and

22 Albuquerque, New Mexico meetings, and quite
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1 honestly -- quite frankly has been

2 substantially revised, you know, like I just

3 said, not once, but multiple times, and I

4 think that that's worthy of note.

5 The public comment that you're

6 going to see was a discussion document at the

7 Savannah meeting, and then it went to the

8 Albuquerque meeting as well, and the public

9 communications, proposed recommendation is,

10 you know, it has some of that same history,

11 but it's to establish a policy that doesn't

12 exist.

13 So at this point in time, what I'd

14 like to do is, and I will be frank and honest

15 with you. Our most complicated of these

16 three, in various ways for various reasons, is

17 the conflict of interest. But due to the way

18 we had the schedule already, that's going to

19 be the very next one, and that's --

20 What I'm going to do is turn it

21 over to C. Reuben Walker, and he's going to

22 lead us through the conflict of interest. So
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1 thank you.

2 MR. WALKER: Thank you, Colehour. 

3 I would like to begin by saying that conflict

4 of interest, as I mentioned in New Mexico, has

5 been a problem since the beginning of

6 humankind, and today, it is no different.

7 We hope that as we leave from

8 here, that a decision would be made on

9 conflict of interest up or down, and we can

10 move on to something else. Primarily, the

11 conflict of interest was brought about by I

12 call it the "Organic Nation," several groups

13 making a request for more transparency and

14 things centered around conflict of interest.

15 As Colehour, the chair, had

16 mentioned, we went through probably at least

17 30 iterations of this particular document

18 since last year. We have even went as far as 

19 requiring the declaration of interest form. 

20 No board member can lobby the Board until two

21 years afterwards.

22 We had a financial, we had all
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1 kinds of things in this document, and but what

2 we found in doing this is that, and rightfully

3 so, some board members seem sometimes to be,

4 I call it maybe somewhat unfairly picked on,

5 and this is a very sensitive topic.

6 So we decided to take our time,

7 and make sure we get something that hopefully

8 that we can come to a consensus. I believe

9 the attorney from WDA mentioned that at some

10 point, instead of fighting all the time, at

11 some point a consensus need to be done.

12 My view of a consensus is that

13 each side is still pissed off. But we agree

14 to move it along, just for the good of the

15 whole group. So I guess I'll just go the

16 public comment. This is the public comment

17 that was put out.

18 Table 1 shows that it was 104

19 entities or individuals responding to our

20 document. Some of these were form letters. 

21 As you can see, no one supported the document,

22 for various reasons. What the Policy
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1 Committee said that we just wanted to get it

2 out, to let the organic community weigh in on

3 it, because it was changed from the New Mexico

4 meeting.

5 Table 2, if you chisel down, if

6 you take away the form comments, we had

7 roughly 25 different commenters, groups or

8 individuals, and again, zero percent was for

9 what was placed out there for various reasons.

10 Another question we wanted to know

11 was in our current policy and procedure

12 manual, and we have seen quite a few former

13 Board members, and when they was on the Board,

14 conflict of interest were mainly led by the

15 Board itself, and that particular writing it

16 still is in our policy document, on pages 9,

17 10 and 11. 

18 So essentially with this new

19 document, we have agreed to keep it that way,

20 that the Board maintain that particular

21 wording, that NOSB determine a conflict of

22 interest. But we know that AMS and NOP is the
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1 final arbiter of anything that we might do. 

2 That's a fact. So that's where we're at.

3 That will take care of that, and

4 what I would like to do next is Michelle will

5 go, will assist me here. This is the document

6 that was put out for public comment. It's

7 eight pages, and this shouldn't take long,

8 because I'm going to go through it pretty

9 fast.

10 Page one, there was no change. So

11 we can go down to, Michelle if you don't mind,

12 to the recommendations. What we wanted to do

13 as a Committee was to show what was placed out

14 for you all to review. Then we wanted to show

15 in yellow -- I had some problem with some of

16 this. Some of it was in green, but anything

17 colored is what we changed.

18 How did we change it? We changed

19 it based upon the public. NARC, Cornucopia,

20 OTA, WDA, and essentially what I did, I made

21 a grid for all the objections. Some of the

22 trade groups said keep the conflict of
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1 interest policy as it was.

2 If that be the case, we have that

3 in this document. The NOSB Board make the

4 initial determination, and the NOP will be the

5 final arbiter.

6 So Recommendation 1, everyone

7 agreed to that one, of all the stakeholders. 

8 Recommendation No. 2, there was an agreement. 

9 Simple. We just wanted to add the word

10 "proposed inclusion" into the language. 

11 So Recommendation 3. In

12 Recommendation 3, with respect to Michael

13 Jackson, we moonwalked back on this one. The

14 issue we had here, what the public had was it

15 said that all of us was to represent the

16 interest of the entire organic community.

17 But what stakeholders said, that

18 we was placed on this Board to represent the

19 interest in which we was appointed. So

20 essentially, we put the language back. 

21 Organic farmers should represent

22 the interests primarily of organic farmers,
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1 retailers, retailers, handlers, handlers. But

2 not to overlook the entire organic community,

3 but we was primarily to represent the

4 interests in which we was appointed, and what

5 we had out there was different.

6 So we just essentially placed back

7 what we had in the policy manual, and that's

8 been there for the last, since 1999. So

9 what's in yellow is what we placed back. 

10 Instead of saying "board members," I just said

11 his or her, to try to be more personable. So

12 we essentially changed the language back to

13 what we had.

14 What you see in blue redacted is

15 what we had out there, that stakeholders did

16 not like. So we've just taken that back out,

17 kept the policy.

18 Recommendation 4. That was okay.

19 Recommendation 5, disclosure of financial

20 interests. What we decided to do here was to

21 say that in our policy manual, it says

22 "recognize corporate opportunity."
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1 So we wanted to change that to

2 "disclosure of financial opportunity," because

3 when you say "corporate," it seems like, you

4 indicate that you're picking on those who may

5 have a corporate leaning, and that is unfair

6 and that is unjust.

7 So what we tried to do was to say

8 we all could have a possible conflict of

9 interest, and we need to disclose it. So what

10 the Committee decided to do was let's remove

11 the term "recognize corporate opportunity,"

12 because it seemed to be, give the indication

13 you're singling out a particular group.

14 Recommendation No. 6. Let's see

15 here. Essentially, this goes back to the

16 first one. It says "NOSB members shall, with

17 the various backgrounds, are recruited to

18 provide a balance to the Board." While the

19 individual NOSB members represent the segment

20 of the population from which they were

21 selected.

22 They are also to represent the
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1 greater good of the population as a whole. 

2 You can see what was redacted. Essentially,

3 it said that we all was to represent the

4 entire community, and we were not appointed by

5 the Secretary of Agriculture and AMS and NOP. 

6 We was not appointed for that. We was

7 appointed for a particular, to advocate for a

8 particular position.

9 So we essentially put the language

10 back that we have in our policy manual. To

11 me, our policy manual is the NOSB Board's

12 Bible. So we don't want to change the bible

13 too much, that it would take away from its

14 effect.

15 Recommendation No. 7. We have 11,

16 so it won't be long. Number 7, essentially

17 where we had "NOP," we returned that back to

18 "NOSB," the language that we had at the New

19 Mexico meeting and Savannah meeting.

20 So what's in yellow, a conflict of

21 interest. The long and short of this is the

22 definition was quite lengthy. It had
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1 entities, it had organizations. In Louisiana,

2 we call it, it was a gumbo. It had some of

3 everything in it. 

4 What we decided to do was to deal

5 only with a direct financial gain, as opposed

6 to a direct financial interest and affiliates

7 and all those things. So in essence,

8 Recommendation 8 was we reduced it to a direct

9 financial gain.

10 Also, potential conflict of

11 interest was redacted. No one seemed to have

12 liked that in the public comments, trade

13 associations and the public interest groups.

14 Now bear in mind that this doesn't mean that

15 it will not show up again, because the NOP

16 will begin with ethics, to make sure that this

17 is proper.

18 Immediate family member. This was

19 added. What you all read was it was in the

20 definition of a conflict of interest. So what

21 we decided to do was actually just pull that

22 definition out, as opposed to just keeping it
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1 in the definition of a conflict of interest.

2 And also, immediate family members

3 is also in our policy on page 11. So the term

4 in the definition of immediate family member

5 is not new. It's already existing in the

6 document already.

7 Okay, number 9. No one seemed to

8 like this one. I was surprised on this one. 

9 They didn't like the direct financial

10 interest. So trying to build a consensus at

11 our level, we decided to put the term back,

12 what we originally had in Savannah and New

13 Mexico, which was "direct financial gain."

14 Stakeholders said that direct

15 financial interest was too broad, why did you

16 cut it off, those sort of things. So we

17 thought at our level, we'd just return it back

18 to what we have in our policy.

19 Number 10. Essentially, we

20 returned back and added. What we returned was

21 that we wanted to show that NOSB is, I would

22 say "will take the lead" in determining if
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1 there's a disclosure. The Subcommittee or

2 this Board will make that first determination.

3 But we do know that if the program

4 object, they would be the final arbiter,

5 because that just the way it is. So

6 essentially at the Subcommittee level, when

7 work plans are done and for those of you who

8 are not familiar, at some point after this

9 meeting, we would get together and determine -

10 - I think we already determined that now

11 right, work plans?

12 Work plans are actually decided,

13 and as November, December, January go along,

14 we'll determine if all these things going to

15 stay on each of the subcommittees' work plan. 

16 We are asking that fellow Board members and

17 subcommittees disclose early on if they have

18 a conflict of interest. 

19 If they do, then happens to be

20 determined at the subcommittee level, and it

21 need to be documented in the minutes. This

22 would be done in conjunction with the program. 
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1 At the Subcommittee Level 2, that's the next

2 page, and all you're seeing in blue is what we

3 kind of redacted.

4 Yes, this one here. Yes, okay. 

5 At the biannual meetings, at the beginning of

6 each subcommittee, we are asked -- the chair

7 is to ask committee members or Board members

8 if they want to disclose any potential

9 conflict of interest, any conflict of

10 interest, as we did somewhat during this

11 meeting.

12 So it need to be disclosed in the

13 public, and not at a level where one do not

14 know. So what is in blue, I apologize for not

15 being able to read it, but the scratch-through

16 is what we put out, that individuals tended to

17 have a problem with. So essentially we kind

18 of returned this back to what we had at a

19 previous Board meeting.

20 Next recommendation, or going

21 further down the next page. I think one of

22 the problems that I would like to note here,
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1 we had an issue of three days that the program

2 will decide if there was a conflict.

3 That was an error. That was taken

4 out. We also said that if there is any

5 revote, that would be not retroactive. 

6 Several groups did not like how far do we go

7 back.

8 Do we go back to 2002 and revote

9 on an issue, and the Board, the committee

10 decided that the revote would only come into

11 play if necessary, and determined by NOP, once

12 this particular document is finally approved

13 at a level above us.

14 And recommendation No. 11. No one

15 liked this particular recommendation. Whether

16 it was trade association or community-based

17 groups or individuals. So essentially what we

18 have here is that we just returned the

19 language of Recommendation 8 back to where it

20 was in our policy manual.

21 The last slide, oh I see. I

22 didn't have it on the other one. It's not
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1 there. But that's it. So essentially we are

2 putting before the Board as a whole and the

3 organic community, because what you've seen

4 out there, you have expressed to us that you

5 didn't like it.

6 So essentially we have went back

7 and made quite a few changes, substantial

8 changes as Mr. Colehour mentioned, and we are

9 hoping that this Board tomorrow will digest

10 it, and maybe we can move something forward. 

11 There's no guarantee that it would be accepted

12 all by the program.

13 But if we can get a strong vote up

14 or down, a strong vote would be better for

15 NOSB. If it's voted down, it may not be as

16 good.

17 So that's where we're at, and my

18 collaborator here was Mr. Joe Dickson, and the

19 reason why we like it is because when you get

20 a public interest, you get the retailer, you

21 get the environmentalist, you come up with a

22 pretty good document.
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1 So we're hopeful that, tomorrow

2 that we can get this through in some form. 

3 Thank you. 

4 MR. BONDERA: Very good. Thank

5 you very much, Mr. Walker, and I appreciate

6 the complexity of what you were presenting. 

7 So we will keep working on that. 

8 The next thing that we're going to

9 do is go ahead and listen to the presentation

10 of the next recommendation that's on the

11 table, which is -- the title of it is public

12 comment, and I am going to present that to

13 you.

14 So hopefully here it comes. So

15 the truth is that this is going to be -- what

16 Calvin just took us through, he has notably

17 and significantly modified from what was put

18 forth to the public and the realistic truth is

19 that this particular one does not have any

20 changes at all.

21 So we're just going to go through

22 it, and I think pretty quickly. This is about
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1 the policy for public comments at NOSB

2 meetings, and I think honestly, Calvin went

3 through the process very well, and I

4 appreciate that he thanked Joe for his help on

5 the conflict of interest one, and I'd like to

6 start out by doing the same with Jean, who --

7 Jean Richardson, who really played a

8 significant role in helping me work on this,

9 and get it to where it's at. So thank you,

10 Jean.

11 I have led the efforts on this

12 particular topic, both through the discussion

13 document form and as well as to our last

14 meeting in Albuquerque. The goal of this is

15 to amend Section, I guess it's Section 6 of

16 the policy procedure manual, which is entitled

17 "NOSB Policy for Public Comment at NOSB

18 Meetings." These are the new words that we

19 have put forth.

20 So I'll just go ahead and read

21 them to you. There's ten points. The first

22 one is "All persons wishing to comment at NOSB
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1 meetings during public comment periods must

2 sign up in advance, per the instructions in

3 the Federal Register notice for the meeting."

4 Number two is "All presenters are

5 encouraged to submit public comment in writing

6 according to the Federal Register notice. 

7 Advance submissions allow NOSB members the

8 opportunity to read comments in advance

9 electronically, and decrease the need for

10 paper copies to be distributed during the

11 meeting."

12 Number three is "Persons will be

13 called upon to speak in the order they sign

14 up. Persons called upon who are absent from

15 the room could potentially miss their

16 opportunity for public comment." 

17 Number four. "Time allotment for

18 public comment per person will be four

19 minutes, with the options of reducing to a

20 minimum of three and extending to a maximum of

21 five minutes at the discretion of the NOP,

22 working closely with the NOSB chair, in
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1 advance of the meeting."

2 Sorry. Yes, next slide. Sorry, I

3 didn't say that. Sorry, I'm looking at my

4 screen and not up there. I apologize. Too

5 many things going on, and I'm tired like all

6 of us. So I hereby take full responsibility

7 for that error, and I hope you'll all just

8 deal, as I read through them, even if they

9 aren't on the screen.

10 Number four. Time allotment for

11 public comment -- I already read that.

12 Number five. "Persons will give

13 their names and affiliations for the record at

14 the beginning of their public comment. 

15 Number six. "Proxy speakers are

16 not permitted."

17 Number seven. "Public comment

18 requests may be scheduled by major topics

19 under consideration, as we have -- my comment

20 on that is as we have eased into doing,

21 starting at the Albuquerque meeting, and now

22 it seems like that is our modus operandi." So
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1 that's how people are grouped together.

2 Number eight. "Individuals

3 providing public comment will refrain from any

4 personal attacks and from remarks that

5 otherwise impugn the character of any

6 individual." 

7 Finally, number nine. "The NOSB

8 will attempt to accommodate all persons

9 requesting public comment time. However,

10 persons requesting time after the closing date

11 in the meeting notice or during last minute

12 sign-up at the meeting, will be placed on a

13 waiting list, and will be considered at the

14 discretion of the NOP, working closely with

15 the NOSB chair, depending on availability of

16 time."

17 Number ten. "Members of the

18 public are asked to define clearly and

19 succinctly the issues they wish to present

20 before the Board. This will give the NOSB

21 members a comprehensible understanding of

22 speaker concerns."
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1 And so I think like I wrote here,

2 we didn't receive that many written comments

3 on this topic, and really, all of them were

4 supportive, even when there was a little bit

5 of reluctance in the comments we received, in

6 terms of I think notably the amount of time

7 involved.

8 I think that the other thing worth

9 noting, in terms of written testimony that

10 we've received, is that the one thing that is

11 sought in that testimony is that there would

12 be no restrictions on questions and discussion

13 by NOSB members.

14 I think the honest truth is that,

15 you know, that's going to have to be worked in

16 as is viable, depending upon what our volume

17 of people is and what our topics are. You

18 know, these little -- they aren't quotes

19 actually. These highlights that I've put on

20 this slide are actually from the Albuquerque

21 meeting, not from comment from this meeting. 

22 But I think that they all pretty
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1 much still apply, since we haven't really

2 modified the document very much at all in

3 fact, and I think they still are all relevant. 

4 Allow more time for public commentary is a

5 general feeling that people who comment and

6 communicate about this want and seek.

7 That's why we have public

8 meetings, and you know, so I want to let that

9 proxy topic totally drop, just because it does

10 have history within the NOSB and I think that

11 noting that people do feel like it's helpful

12 for public interest organizations is relevant.

13 What I just said, I think, is also

14 notable, in terms of the fact that the

15 circumstances go into define how things really

16 are played out, and I think in my opinion, as

17 organics grow and, you know, as a meeting

18 plays out, what is anticipated if it's a

19 heavily attended meeting, where a lot of

20 people are interested in the subject areas,

21 and/or it's held in an area where there's a

22 lot of, I don't know what descriptor to use,
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1 but vibrance about the topics at hand, then I

2 think that we may have, you know, an issue in

3 terms of how many people have to speak and how

4 much time.

5 I think that those issues will

6 have to just be dealt with, and we all will

7 need to be flexible, according to the

8 circumstances. So I think that that highlight

9 really still pertains.

10 I also do think it's still worth

11 noting that like I alluded to earlier, the

12 reluctancy of the support that the written

13 comments that came in on this, you know, were

14 not exclusively and not solely, but were

15 related to, you know, the five minutes instead

16 of four minutes.

17 Then with the concept of adjusting

18 it downward rather than upward. So I just

19 thought those were worth repeating for you

20 all. The final words I want to just share

21 with you are, you know, the reality is that --

22 Well, I'll be honest with you all,
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1 and I don't feel bad about it, but you know,

2 Barry Flamm served as the chair of the Policy

3 Development Subcommittee for four years, and

4 you know, he's not the easiest act to follow.

5 I think that that's, you know, I

6 respect and think that Barry deserves the

7 honor that he has earned. But I think that

8 the truth is that I have tried as hard as

9 possible to work with the National Organic

10 Program, and get their input, and they have

11 worked with us and have chosen to, you know, 

12 point out some of the clear facts, that the

13 truth is that the Designated Federal Officer

14 is ultimately responsible for the NOSB meeting

15 schedule.

16 I think that that is the truth. 

17 No matter how this plays out or what the

18 process is, you have to fit all the things

19 into the reality. I think that that is

20 critical.

21 We're going to have, after our

22 third presentation, we're going to have live
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1 testimony and, you know, the live testimony

2 can also affect both the full NOSB discussion

3 and then the final vote on the proposed

4 recommendations. 

5 So I encourage those that are

6 going to provide testimony to recognize that,

7 and I'll just finish up with that. Thank you. 

8 Mahalo. At that moment then, what I want to

9 do is ask -- Jennifer is going to present the

10 third subject to us, and her topic is public

11 communication.

12 Like I said before, it's something

13 that doesn't exist per se in the policy

14 procedure manual. So it's a new subject,

15 although she has in Albuquerque already

16 presented it to us. So it's not all fresh and

17 new, but I'll turn it over to Jennifer. Thank

18 you.

19 MS. TAYLOR: Thank you, Colehour. 

20 Okay. We will review and now discuss as well

21 the public communications document. Okay.

22 "A primary role of the National
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1 Organic Standards Board is to advise and

2 counsel the Secretary, to represent the

3 segments of the population from which they

4 were selected, and to treat the business of

5 the Board as fiduciaries for all members of

6 the organic community and public at large."

7 That's coming from the Policy and Procedures

8 Manual. 

9 The Organic Foods and Protection

10 Act states that "The statutory mission of the

11 NOSB is to assist in the development of

12 standards for substances to be used in organic

13 production, and to advise the Secretary on any

14 other aspects of the implementation of this

15 title." Okay, thanks.

16 Okay. Can we go to the next

17 slide, please? Thank you. Again as stated,

18 within the Policy and Procedures Manual, the

19 NOSB mission statement is to provide effective

20 and constructive advice, clarification and

21 guidance to the Secretary of Agriculture

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

2 The Federal Advisory Committee Act

3 meeting obligations to the public suggests

4 that any member of the public is permitted to

5 file a written statement with the advisory

6 committee during meetings. 

7 In addition, the NOSB infrequently

8 receives public communications outside of the

9 designated public comment period. These

10 communications include verbal and written

11 information.

12 Due to the opportunities that the

13 Board has to hear from the organic community, 

14 in the course of fulfilling its mission, it

15 has both an opportunity and responsibility to

16 bring to the Secretary of Agriculture

17 information that it believes may impact on the

18 implementation of the Organic Foods Production

19 Act.

20 This communication may, by

21 necessity, extend to organic standards and

22 practices, as well as related issues that may
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1 affect those standards and practices. 

2 Therefore, based on the

3 communications and input it receives from the

4 public, the National Organic Standards Board

5 may provide effective and constructive advice,

6 clarification and written information as it

7 deems necessary directly to the Secretary of

8 Agriculture after each of its Board meetings.

9 Additionally, and as a part of its

10 responsibility to communicate with the organic

11 community, pertaining to the implementation of

12 the Organic Food Protection Act, the Board

13 must receive and review information from the

14 NOP and other sources during its

15 deliberations.

16 As a stakeholder board, the input

17 from the organic community is valuable in the

18 deliberations of the Board, and the community

19 decision-making process. The procedures of

20 the Board should facilitate public

21 communication to inform these deliberations,

22 and we'll follow with recommendations.
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1 The public, I'm sorry, the Policy

2 and Procedures Manual, Section 6,

3 Miscellaneous Policies, page 26, is amended by

4 adding a new subcategory that states "The NOSB

5 policy on its advisory role in communications

6 with the Secretary of Agriculture. Based on

7 the communications and input it receives from

8 the public, the National Organic Standards

9 Board may provide effective and constructive

10 advice, clarification and written information 

11 as it deems necessary directly to the

12 Secretary of Agriculture, after each of its

13 Board meetings.

14 "This information is intended to

15 facilitate public communication with the

16 Secretary on critical issues that may emerge,

17 that it believes are important to the

18 implementation and integrity of the organic

19 standards and practices under the Organic Food

20 Protection Act.

21 The policy and procedures manual

22 Section 6 is amended by adding a new
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1 subcategory. NOSB policy for public

2 communication between NOSB meetings. "The

3 NOSB seeks public communication outside of the

4 Board meetings and public comment periods, to

5 inform the Board and program work.

6 "The Policy and Procedures Manual,

7 Section 2, role of the executive director, is

8 amended to include the following language: 

9 "Identify, implement, administer and maintain

10 a year-round mechanism by which public

11 feedback can be received, posted and archived

12 for viewing by the NOP, the NOSB and by the

13 public itself."

14 Now this document has been before

15 the public before, and we received several

16 comments from the public, all in support of

17 the document. We received comments also from

18 the program that were in support of the

19 document as well.

20 This is a representative comment

21 from the public. "I support both aspects of

22 the proposed public communications policy. 
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1 The ability for the NOSB to inform the

2 Secretary of the organic community's views is

3 critical, particularly for views that are

4 contrary to USDA's other policies. It is also

5 important that NOSB members be able to receive

6 input from the organic community during all

7 stages of deliberations." 

8 Another method that was used was

9 to state "We fully support the following

10 additions to the policy manual, as proposed by

11 the Policy Development Subcommittee." 

12 We also received a question during

13 this period, during this fall meeting period,

14 and the questions were "Will NOSB members have

15 to check or will they receive the comments in

16 their email. Will someone alert them if

17 something is posted?"

18 We thought about that same thing

19 actually, and what we're hopeful of is that

20 the communication that we've established with

21 a program through the docket system, we will

22 receive an alert and we will receive an alert
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1 that the information is being deposited there.

2 "Is there an opportunity for the

3 NOSB members to respond? Two-way

4 communication is important." We also realize

5 that two-way communication is important, and

6 we're hopeful that we'll be able to respond as

7 well to those comments that we receive.

8 The Subcommittee vote on this

9 particular document is reported as you see. 

10 We had a vote of eight in support of the

11 proposed document. Colehour, I return.

12 MR. BONDERA: Thank you very

13 much. Very good. At this point in time, even

14 though we are running slightly late, I would

15 like to turn to the people that have signed up

16 to provide us with live public testimony, and

17 the first one that I have on the sheet is

18 Marnie Karlin, followed by Andy Pollock.

19 So if you can be ready, I will be

20 corrected if it's inaccurate. But the third

21 one I have is Rosemary Galiani. So in that

22 order, if you will please share with us. 
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1 Thank you.

2 MS. KARLIN: Thank you. Good

3 afternoon, and thank you for the opportunity

4 to comment today. My name is Marnie Karlin,

5 and I am Associate Director of Legislative and

6 Legal Affairs of the Organic Trade

7 Association.

8 Just by way of background, I came

9 to OTA after nearly four years as counsel to

10 the United States Senate Judiciary Committee,

11 and before that I practiced law in Washington,

12 D.C. for almost eight years.

13 I also bring with me a little food

14 cred, as I hold a degree from the Cordon Bleu

15 Culinary School, and now I'm here, commenting

16 at my first NOSB meeting. Unfortunately, OTA

17 could not support the proposed changes to the

18 COI policy circulated before the meeting.

19 But we thank you very much for the

20 changes that Calvin explained, that address

21 many of our concerns, and leave me with very

22 little to comment on. I'll just outline some
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1 of our concerns, just to add a little color,

2 as to perhaps why some of those changes may

3 have been made.

4 NOSB is a FACA board, an advisory

5 board prohibited from creating policy or

6 issuing regulations. Actual decision-making

7 is done by USDA officials, who are subject to

8 strong COI policies.

9 Your purpose is to provide advice

10 from the perspective of interested parties,

11 which only happens when you each represent

12 your constituencies.

13 You are all chosen because of your

14 professional expertise in a particular area,

15 selected to provide particular points of view. 

16 The Board as a whole represents the entire

17 organic industry, but for you to function as

18 Congress intended, each member must represent

19 his or her particular constituency.

20 This leads us to what I see as a

21 misunderstanding between a conflict of

22 interest and an interest. Some commenters
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1 suggest that any time a Board member has an

2 interest, he must disclose it for analysis of

3 whether a conflict exists.

4 That is belied by the purpose of

5 the Board. Each of you brings a set of

6 interests -- that is exactly why you were

7 appointed -- to bring your relevant interests

8 to bear as you advise the Department. You

9 were each selected to represent your

10 constituency, farmers, handlers, scientists,

11 and you would not be doing your job if you did

12 not represent that interest.

13 Now a conflict of interest is

14 different. It arises when a member's interest

15 conflicts with his official responsibility. 

16 When serving on a FACA board such as NOSB,

17 your official responsibility is to have an

18 interest and represent that interest.

19 It is only when your personal

20 interest conflicts with your ability to

21 represent your constituency's interest, that

22 any conflict would arise. It is important
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1 that we not show having an interest, but

2 regulate only conflicts.

3 I'd also like to talk for a minute

4 about transparency. Some commenters suggest

5 that transparency requires open discussion of

6 individual Board members' personal interests. 

7 Respectfully, this misunderstands the

8 transparency requirement. 

9 Transparency is absolutely

10 important, but does not require or even

11 suggest public discussion of Board members'

12 personal interests. FACA's transparency

13 requirements are that Board advice is

14 accessible to the public, and committee

15 meetings are open to the public.

16 As we've seen this week, NOSB

17 meetings, deliberations and votes are public,

18 and public comment is welcome. FACA-required

19 openness already does what a stringent COI

20 policy must do in less open government

21 processes: it shines light on and makes

22 transparent the process, so the decision-maker
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1 and the public know what interests were

2 represented.

3 Finally, I'd like to thank you for

4 a couple of changes in specific areas where

5 the original proposal went too far. First, it

6 allowed application of a new COI policy

7 retroactively to votes or deliberations taken

8 before adoption of the new policy.

9 Not only is that a bad idea, but

10 U.S. jurisprudence is clear that retroactively

11 is not favored in the law. Finally, we oppose

12 the terms of "potential or perceived conflict

13 of interest," which are uncertain, vague and

14 overbroad. So we appreciate them being

15 stricken as well. Thank you for your time.

16 MR. BONDERA: Thank you very

17 much. Any questions for Ms. Karlin? Jay.

18 MR. FELDMAN: Thank you for your

19 statement. Do you have any comment on the

20 revisions that -- I know it's --

21 MS. KARLIN: So I just heard them,

22 you know, five minutes ago. At first blush,
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1 they look like a much-improved proposal. I

2 would love to have a moment to actually read

3 through them before I make an official, you

4 know, have an official statement on behalf of

5 OTA. But I'd be happy to do that if I could

6 take a read on them.

7 MR. BONDERA: Thank you. Any

8 other comments? Harold.

9 MR. AUSTIN: I know you haven't

10 had a chance to see some of the revisions that

11 they just made. I'd be interested in your

12 feeling on the conflict of interest policy

13 where we're putting the verbiage back in, that

14 that, those decisions would be controlled by

15 the NOSB Board itself, rather than being

16 directed firsthand through the NOP. What are

17 your thoughts there?

18 MS. KARLIN: That tends to concern

19 me a little. I tend to feel that there is an

20 opportunity for NOSB members to have their own

21 interests in whether or not something is

22 determined a conflict of interest.
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1 That raises a bit of concern for

2 me, in terms of that being where the decision

3 is made. So I generally prefer seeing an

4 objective, outside body of the NOP making that

5 decision. 

6 MR. BONDERA: Any other

7 questions? 

8 (No response.)

9 MR. BONDERA: Very good. Thank

10 you very much.

11 MS. KARLIN: Thank you.

12 MR. BONDERA: Do we have Andy

13 Pollock present?

14 (No response.)

15 MR. BONDERA: Okay. Hearing and

16 seeing no response, Rosemary Galiani. Thank

17 you. Please introduce yourself.

18 MS. GALIANI: Hello. You got my

19 name correct. My name is Rosemary Galiani. 

20 I am general manager for the Alternative Food

21 Coop.

22 We're located in Wakefield, Rhode
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1 Island, which is just about 30 minutes south

2 of here. We've been in business for over 40

3 years, we have 600 members, and I'm here today

4 as the manager, to urge the NOSB Board to keep

5 the organic standards clean.

6 Our members and our shoppers want

7 to know what is in their food. I am also a

8 member of the Cornucopia Institute, and I'm

9 here today as a citizen lobbyist. Cornucopia

10 believes that the conflict of interest

11 proposal is a step in the right direction in

12 the current policy.

13 We are especially concerned with

14 the suggestion that the Board members disclose

15 conflicts to the NOP, but not to the public. 

16 Organic stakeholders would like to see greater

17 transparency, not less.

18 Since the NOP has demonstrated it

19 is unlikely to ask a Board member to recuse

20 him or herself, as happened at the last

21 meeting with the carrageenan vote, this could

22 lead to a situation where the NOSB itself has
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1 no control over the conflict of interest, and

2 the public might not even know whether

3 potential conflicts were declared.

4 We question where this change in

5 the proposal came from. We support keeping

6 this important responsibility with the Board. 

7 We also note that the contracts for technical

8 review are still missing from the proposed

9 conflict of interest policy, despite repeated

10 requests by numerous public interest

11 organizations to add them.

12 Currently, even the identity of

13 technical reviewers is not publicly available,

14 much less the potential conflicts. Technical

15 review essentially happens behind closed

16 doors.

17 We urge you to add a line in the

18 proposal to require technical review

19 contractors and researchers to sign the

20 conflict of interest statement prior to

21 commencing work on the TR.

22 We also question the claims made
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1 by some groups and individuals in public

2 comment that the Board is supposed to

3 represent people with different points of view

4 within the organic community, and that a

5 stronger conflict of interest policy is

6 therefore not needed.

7 This system is simply not working

8 as is designed. We have seen too many

9 corporate representatives, all with conflicts,

10 vote on issues while they are serving in seats

11 legally reserved for farmers, consumers and

12 scientists.

13 When the system breaks down, as it

14 has, a conflict of interest policy is needed

15 to provide checks and balances. For example,

16 in recent NOSB history, we have seen an

17 employee of General Mills, a $16 billion

18 corporation in the scientist's seat, who

19 failed to disclose a conflict when her

20 employer had a license agreement with the

21 petitioner for the very same substance that

22 was being petitioned. That's Martek DHA.
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1 We have seen the CEO and employer

2 of an individual in a pharma slot directly

3 contact NOSB members to lobby for a yes vote

4 for carrageenan, while the NOP decided that

5 this pharma Board member had no conflict.

6 If that -- your own boss actively

7 lobbying other Board members -- doesn't

8 constitute a conflict of interest, than what

9 does? The system is clearly broken and needs

10 to be fixed. We would like to see more

11 transparency, not less; more integrity, not

12 less.

13 With regard to your public comment

14 proposal, please allow for unlimited questions

15 and answers. Experts often travel great

16 distances to attend these meetings, and Board

17 members should have the opportunity to

18 publicly engage with public presenters until

19 their questions have been answered. I thank

20 you for your time. I'll answer any questions.

21 MR. BONDERA: Thank you, Ms.

22 Galiani. Any Board member questions?
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1 (No response.)

2 MR. BONDERA: Very good. Thank

3 you for your time. I do thank you. This

4 microphone and me are not having the best

5 time, and I apologize. It keeps considering

6 not being on.

7 At this point in time, we have

8 finished with the Policy Development

9 Subcommittee's presentations and testimony,

10 and I would like to call a 15-minute break so

11 that the Policy Development Subcommittee can

12 huddle together and regroup about our voting

13 process, so we can finish up this day.

14 So if that's alright with you, Mr.

15 Chair, I would like to reconvene at five after

16 5:00.

17 CHAIRMAN FLAMM: That is fine. 

18 We'll reconvene at five minutes after 5:00.

19 (Whereupon, the above-entitled

20 matter went off the record at 4:49 p.m. and

21 resumed at 5:03 p.m.)

22 CHAIRMAN FLAMM: We've got the
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1 chair of the Policy Subcommittee, and I guess

2 we can resume now. 

3 MR. BONDERA: Very good.

4 CHAIRMAN FLAMM: Colehour, I

5 understand that the committee has made some

6 decisions on how you wish to proceed for the

7 rest of the afternoon.

8 MR. BONDERA: Yes. Thank you

9 very much, Mr. Chair. At this point in time,

10 based on the discussion within the Policy

11 Development Subcommittee, we have decided that

12 we would like to move forward with our

13 recommendation on public comment and our

14 recommendation on public communications, and

15 postpone our conflict of interest topic until

16 tomorrow so there's more time for discussion

17 about the changes that have happened to the

18 proposed recommendation as it was put forth to

19 the public, since as you saw, there's a fair

20 number of lines crossed off and a fair number

21 of new ones.

22 I want to give the opportunity to
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1 entire NOSB members who are not on the Policy 

2 Development Subcommittee an opportunity to be

3 prepared with their discussion points and

4 questions when we deal with that, and you

5 have, according to my watch, you know, well

6 over 12 hours to do so. So I'm sure that

7 that's enough time for everybody involved.

8 In any case, so that's our

9 intention, and we have, like I said, two

10 subject areas, and I would like to start out

11 the process, before a motion is made, by

12 asking the NOSB members if there is -- and I

13 do hope we can all, we all already know the

14 answer to this.

15 But nonetheless, just to give the

16 opportunity, in case there is any rationale or

17 logic for any recusals or information-sharing

18 on conflict of interest related to the policy

19 development, this is an opportunity to do so. 

20 So I welcome anybody who has something to put

21 forth in that regard.

22 Very good. Hearing and seeing no 
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1 reaction or action on that, I will move us

2 forward to considering the recommendation, and

3 first the one that I presented on public

4 comment, and so like I said, the

5 recommendation is to amend Section 6 of the

6 PPM, and I don't know if Michelle wants to put

7 it up on the screen, because I didn't prep her

8 put it up on the screen.

9 But know, the actual wording of

10 the actual recommendation, the motion, because

11 otherwise, I have to read through the whole

12 motion again to present it. 

13 So it's the same one that's in

14 the, what was publicized too. I don't know

15 whether you have it. Sorry. I apologize for

16 that delay.

17 In any case, I will actually make

18 that motion at this point in time, that we do

19 amend the policy procedure manual as that

20 reads, and would be happy to entertain a

21 second to that motion.

22 MS. RICHARDSON: Second the
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1 motion.

2 MR. BONDERA: Thank you very

3 much.

4 CHAIRMAN FLAMM: It's been moved

5 and seconded.

6 MR. BONDERA: Thank you.

7 CHAIRMAN FLAMM: Colehour? It's

8 been moved and seconded. If I understand,

9 your motion is to change the -- to add to the

10 Section 6 of the policy and procedure manual,

11 the following recommendation, and those

12 recommendations are numbered 1 through 10, as

13 shown on the screen.

14 If everybody is satisfied with

15 reading it themselves, rather than have

16 Colehour re-read it. Is there any desire to

17 have Colehour read the full motion? 

18 (No response.)

19 CHAIRMAN FLAMM: If not, is there

20 any discussion? Mac.

21 MR. STONE: I haven't asked

22 presenters specifically, but from this vantage
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1 point, it seemed like the presenters were more

2 comfortable with a four-minute delivery. I

3 thank Michelle for the little beeping light

4 thing. I think that gave them some time to

5 help their cadence.

6 So obviously I want the public to

7 know too that there's uniform interest for

8 this Board to maximize public comment time

9 because it is deemed extremely valuable. But

10 I think the four minutes was way better than

11 three. 

12 CHAIRMAN FLAMM: Any other

13 comments or discussion by the Board? John.

14 MR. FOSTER: Thanks. So on point

15 number one, it says -- basically it says

16 you've got to sign up ahead of time, and then

17 in number nine it says you can do something

18 else. So I'm wondering if there's a way to

19 reconcile that.

20 Number one just says very clearly

21 everyone who wants to speak has to sign up

22 ahead of time. Number nine, I think, it says
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1 that, well, actually you can sign up according

2 to certain, if certain criteria are met. I'm

3 wondering if we can change number one to be

4 something other than absolute because clearly

5 we don't want it to be absolute. You know

6 what I mean?

7 MR. BONDERA: So you're

8 specifically referring to the word "must" in

9 that sentence?

10 MR. FOSTER: Yes. Sounds pretty

11 absolute, and maybe it's no big deal. Maybe

12 no one else is worried about it, but I just

13 hate putting something in one part of a new

14 document, and then somewhere else in that same

15 document we're saying we're not going to

16 follow what we just said.

17 Maybe no one else -- I don't know. 

18 It doesn't, that's not my preference. Anyway,

19 if no one else is worried about it, I'll pass. 

20 But it seems like you could build, you could

21 put all that into one point, and then be not

22 contradicting yourself. That's my first
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1 question.

2 Or if there's a reason to do it

3 this way, tell me what that is, please.

4 CHAIRMAN FLAMM: Nick. I'm sorry,

5 John. Have you finished?

6 MR. MARAVELL: I agree with John,

7 and I was about -- he stated what I was about

8 to state. It might make sense just to put it

9 all in one point. I would hate to sit here

10 and wordsmith, but I would leave that to the

11 discretion of the Subcommittee, to get the

12 commas and the tenses and everything else

13 straightened out.

14 But I would say we should

15 encourage, you know, we encourage everyone to

16 sign up in advance, and then go on for point

17 number nine, saying if you don't sign up in

18 advance, then this is what happens.

19 CHAIRMAN FLAMM: Colehour, would

20 you like to respond to --

21 MR. BONDERA: Yes. I think in

22 one second I will, sorry. I'm just looking at
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1 the screen, I apologize. Yes. I think that

2 in my opinion, and I thank you for your

3 comment, John. I think if that word "must"

4 were to change to the word "should," and

5 number nine was simply put as a continuing,

6 just take everything that's in number nine, no

7 wordsmithing at all except for that one word

8 I just mentioned.

9 Take number nine and put it

10 directly after number one, as part of number

11 one. So eliminate number nine and put the

12 text of it at the end of number one.

13 The word "should" means that's

14 what you should do, but that we're going to

15 accommodate people if they otherwise fit in,

16 and then not change any of those other words. 

17 I don't know if that addresses your question

18 sufficiently or not John, but that would be

19 how I'd handle it.

20 MR. FOSTER: Yes, it does.

21 MR. BONDERA: Okay. Did you have

22 some other points? Sorry.
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1 MR. FOSTER: I did. I know this

2 kind of language often uses the word "impugn,"

3 but it's not uncommon to have impugning going

4 on at these proceedings. So by definition, I

5 know we all think it means one thing. It

6 means a little more general than we actually

7 assume it to be.

8 So I'm not suggesting we change

9 it, but those of you who know me know that

10 there's certain words that I like to be very

11 precise about, and impugn has a much more

12 general kind of challenging connotations to it

13 than what we mean, which is don't bad-mouth

14 someone and don't personally attack them. 

15 That's what we mean, and I get that.

16 But impugn is more general. I'm

17 not necessarily saying we change it. I just

18 want to call it to everyone's attention that

19 impugn is a very broad -- it's a very broadly

20 applicable challenge or attack. Accusing

21 something, in this case, a person's character

22 as being false. 
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1 That's a very general statement,

2 and I just want to make sure we know what

3 we're doing when we say that, because we're

4 trying -- I mean this will be a continuously

5 improving document. I'm sure we can always

6 make it better, and I just want to make sure

7 we mean what we say when we say it, that's

8 all.

9 CHAIRMAN FLAMM: Colehour, I think

10 if we're going to do any wordsmithing, we

11 don't have time to do it here. If you wish to

12 do that, I would withdraw your motion and fix

13 it and come back tomorrow, and we can vote on

14 it. We have time tomorrow. John.

15 MR. FOSTER: I want to just make

16 clear, I'm not saying we have to do this in

17 order for me to vote for it or against it or

18 anything. I'm just, I want to get it out

19 there, that this clearly has -- this is a very

20 useful concept to include in our Policy and

21 Procedures Manual.

22 So when we put something in it, I
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1 just want to make sure that we're using the

2 words we mean to use. If no one else, or if

3 we don't -- if there's not general consensus

4 that we need to worry about that, then you

5 know, go with the will of the Board.

6 CHAIRMAN FLAMM: I'm just giving

7 Colehour that option, as the maker of the

8 motion. 

9 MR. BONDERA: Thank you. I

10 think, Mr. Chair, what I would like to do at

11 this time is, and thank you again, John, for

12 your comments, I would like to see if there's

13 any other comments. So that if I make that

14 decision, then I know -- or if I want to

15 withdraw that, that I know what I'm

16 considering.

17 But I think that it does make

18 sense to me. But I'd appreciate wrapping up

19 any other comments, if there are any more.

20 CHAIRMAN FLAMM: All right. Any

21 other -- yes, I got your point. Any other

22 comments or discussion, and if those were
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1 corrected and brought back tomorrow, would

2 that satisfy the Board? Hearing none, I -- we

3 got one.

4 MR. FELDMAN: Yes. I don't have a

5 problem with the word "impugn." I think

6 that's -- we discussed it as a subcommittee,

7 and I think that's what was intended, that

8 there not be any, as you say, broad attack on

9 people.

10 I just think we have other things

11 to do tomorrow, and I also think the issue of

12 aligning number one with number nine is rather

13 simple. We could just say, you know, instead

14 of the word "must," if people feel

15 uncomfortable with that, we could say "must as

16 a general rule," and then add the rest of the

17 sentence in number nine to that paragraph and

18 say "However, if," and then just connect those

19 two thoughts, as you're suggesting, and be

20 done with this, because I think we have other

21 things to do tomorrow, and I think we all

22 basically agree with this.
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1 CHAIRMAN FLAMM: Okay. Colehour,

2 I give you the option, Colehour, of either

3 withdrawing it and fixing it and coming back

4 tomorrow, or restating the motion, with the

5 suggested changes.

6 MR. BONDERA: Thank you. I would

7 like to modify my motion that's on the table,

8 to change number one and number nine, as Jay

9 just presented as a suggestion, and I'm sorry

10 I don't know if I should ask --

11 CHAIRMAN FLAMM: Read the changes

12 out.

13 MR. BONDERA: So, can I read

14 this? May I read it? "All persons wishing to

15 comment at NOSB meetings during public comment

16 periods must, comma, as a general rule, comma,

17 sign up in advance per the instructions in the

18 Federal Register notice for the meeting." 

19 Number nine could remain or could

20 become a part of number one, which I would

21 suggest. "However," and this would become the

22 last sentence in number one. "However, the
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1 NOSB will attempt to accommodate all persons

2 requesting public comment time, comma, delete

3 "however." "Persons requesting time after the

4 closing date in the meeting notice, comma, or

5 during last minute sign-up at the meeting,

6 comma, will be placed on a mailing list and

7 will be considered at the discretion of the

8 NOP, working closely with the NOSB chair,

9 depending on availability." Renumber number

10 ten to number nine, period.

11 CHAIRMAN FLAMM: Do we have those

12 changes, proposed changes recorded? Colehour.

13 MR. BONDERA: Yes, but I don't

14 have them in electronic form.

15 CHAIRMAN FLAMM: I'm taking -- the

16 motion's been withdrawn and a new motion's on

17 the floor. Is there a second?

18 MS. RICHARDSON: Yes, I second the

19 motion.

20 CHAIRMAN FLAMM: Does the Board

21 understand now the changes that were made? 

22 Any questions? Discussion?
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1 (No response.)

2 CHAIRMAN FLAMM: I call for a vote

3 then. Where are we? The vote begins with

4 Jean.

5 MS. RICHARDSON: Yes.

6 MR. WALKER: Yes.

7 MR. BONDERA: Yes.

8 MS. TAYLOR: Yes.

9 MR. MARAVELL: Yes.

10 MR. FELDMAN: Yes.

11 MS. SONNABEND: Yes.

12 MR. STONE: Yes sir.

13 MS. FULWIDER: Yes.

14 MR. AUSTIN: Yes.

15 MS. FAVRE: Yes.

16 MS. BECK: Yes.

17 MR. FOSTER: Yes.

18 MR. DICKSON: Yes.

19 CHAIRMAN FLAMM: And the Chair

20 votes yes. 15 yes, 0 no. Thank you. Your

21 next proposal, Colehour, and that will finish

22 the afternoon.
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1 MR. BONDERA: Yes, very good. I

2 would like to turn it over to the lead on

3 this. Jennifer, if you would present a motion

4 for us, please?

5 MS. TAYLOR: Thank you. Thank

6 you, Colehour and Barry. I would like to

7 motion that the proposal, Public

8 Communications, be accepted. Is that the

9 word? That it be adopted. Thank you.

10 CHAIRMAN FLAMM: We need to either

11 see it or you need to read it, so we know what

12 words.

13 MR. MARAVELL: I think -- let's

14 see if we can get it. Do we have a copy of it

15 for the screen? Yes, that's what we're

16 waiting to see, if we can get a copy of it.

17 MS. TAYLOR: The recommendation is

18 Roman numeral IV. Want me to read it, Barry?

19 CHAIRMAN FLAMM: Well, I think if

20 we could show it on the screen, it would

21 probably be easier for the Board to -- we

22 don't have it.
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1 MS. TAYLOR: We also have it in

2 our agenda items.

3 CHAIRMAN FLAMM: Well then go

4 ahead and read what the recommendation is, so

5 we can get it in the record.

6 MS. TAYLOR: Yes sir, thank you. 

7 "Recommendation 4. PPM Section 6,

8 Miscellaneous Policy, page 26, is amended by

9 adding a new subcategory in italics. NOSB

10 policy on its advisory role and communication

11 with the Secretary of Agriculture. 

12 "Based on the communications and

13 input it receives from the public, the

14 National Organic Standards Board may provide

15 effective and constructive advice,

16 clarification and written information as it

17 deems necessary, directly to the Secretary of

18 Agriculture, after each of its Board meetings.

19 "This information is intended to

20 facilitate public communication with the

21 Secretary on critical issues that may emerge,

22 that it believes are important to the
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1 implementation and integrity of the organic

2 standards and practices under the Organic

3 Foods Protection Act, Production Act.

4 PPM Section 6, Miscellaneous

5 Policies, page 27, is amended by adding a new

6 subcategory in italics. "NOSB policy for

7 public communication between NOSB meetings. 

8 The NOSB seeks public communication outside of

9 Board meetings and public comment periods to

10 inform Board and program work."

11 PPM Section 2, page 13, Role of

12 the Executive Director, is amended to include

13 the following language, in italics. 

14 "Identify, implement, administer and maintain

15 a year-round mechanism by which public

16 feedback can be received, posted and archived

17 for viewing by the NOP, the NOSB and the

18 public itself."

19 CHAIRMAN FLAMM: Thank you. Do we

20 have a second to the motion?

21 MR. FELDMAN: Second.

22 CHAIRMAN FLAMM: It's been
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1 seconded to amend the Policy and Procedure

2 Manual to add communication material. Unless

3 any Board member is unclear on what was read,

4 I'll just -- I'll leave it at that. Is there

5 any need for clarification on what we're about

6 to discuss and vote on?

7 (No response.)

8 CHAIRMAN FLAMM: Hearing none,

9 discussion? Any discussion. Thank you. Zea.

10 MS. SONNABEND: Well I've read

11 this a few times in Albuquerque and now, while

12 I don't really support the bottom part of the

13 recommendation, I just don't understand the

14 point of the first part of the recommendation.

15 So I guess I'm going to abstain,

16 because I just -- I'm afraid that it's -- I

17 mean I don't understand what "effective and

18 constructive advice" means. How do you give

19 the Secretary effective advice, by saying that

20 in advance and it's not really public

21 communication you're talking about. It's NOSB

22 communication with the Secretary.
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1 What you get from the public, I

2 don't know. So I'm having trouble like really

3 understanding the point of it. So I'm going

4 to abstain. 

5 CHAIRMAN FLAMM: Let's see. I

6 think, Nick, you had your hand up first, I

7 believe.

8 MR. MARAVELL: Yes. I think what

9 we're looking at here is the intent. This is

10 establishing sort of the rationale for what

11 we're trying to do. We're trying to provide

12 effective and constructive advice. It's the

13 intent. We can't guarantee it.

14 It's to establish the intent of

15 why we are trying to, in effect, take what we

16 have received from the public and communicate

17 that as part of our responsibility in the

18 statute, to advise the Secretary on any aspect

19 of the National Organic Standards Program. So

20 it's just showing intent. Sort of a

21 rationale.

22 CHAIRMAN FLAMM: John, a comment?
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1 MR. FOSTER: I'm a little with Zea

2 on this. I think our mission and mission

3 statement are pretty clearly defined, what

4 this body is about. It says that. I don't

5 perceive that we have a problem delivering

6 information to the Secretary, either directly

7 or through the NOP, and I guess I am puzzled.

8 This feels like a solution in

9 search for a problem to me, and I don't -- I

10 think what we see here is already covered

11 actually more clearly. I don't see the need

12 for it. Then also, I'm with Zea on the

13 effective advice part. That's been a long14 time bugaboo for me.

15 But the way this is phrased makes

16 it sound like we are to base our input, our

17 effective and constructive advice,

18 clarification or written information, based on

19 the communication input it receives from the

20 public, and I think we should be basing our

21 advice on not just that.

22 This makes it seem like it should
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1 be just that. So that I'm uncomfortable with

2 that. It's very limiting, and I don't think

3 we make our decisions based on one avenue of

4 information.

5 Historically, we certainly

6 haven't, and I think it's pretty clear in our

7 policy and procedures, as well as other

8 guidance we've gotten from the program, and I

9 think the FACA rules are pretty clear.

10 We're getting information from

11 more than there. So I don't like being

12 limited by this, by what this says,

13 irrespective of not knowing what effective

14 advice is, like Zea said.

15 And then -- well, I have something

16 to say on the second part too, but I don't

17 know if you want me to stop there and we can

18 cover that.

19 CHAIRMAN FLAMM: Go ahead. You

20 can finish your comment and then I'll call on

21 Tracy next.

22 MR. FOSTER: Okay. The second
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1 part is I don't think we have an executive

2 director anymore. I know there are a lot of

3 references to it in the Policy and Procedures

4 Manual, and I assume the PDC is going to be --

5 or PDS, rather, is going to be working on

6 getting those changed out to current job

7 titles and what-not.

8 But so I recognize here -- I don't

9 know if we want to continue talking about the

10 executive director, where we're making

11 amendments to the Policy and Procedures

12 Manual, or whether we want to change, use

13 language that's more appropriate for current

14 conditions. That's more a question.

15 CHAIRMAN FLAMM: Thanks, John. 

16 Tracy.

17 MS. FAVRE: I would like to get

18 some clarity around what is the mechanism by

19 which we communicate with the Secretary of

20 Agriculture, and, as well as receive the

21 public communications. Jennifer, you

22 mentioned something about the public register.
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1 But is that the only means by

2 which you intend for NOSB members to receive

3 public comments outside of the specific

4 meeting procedures?

5 CHAIRMAN FLAMM: Nick, you want to

6 respond to that?

7 MR. MARAVELL: Yes, and to John's

8 concerns about the executive director. I

9 think, you know, what we're talking about is

10 house cleaning, and I think that's going to

11 take place at a subsequent time, and really

12 it's not part of this proposal.

13 With regard to the other concern

14 that John had, it's my understanding, and

15 correct me if I'm wrong, is the way you

16 interpret it is correct. We are commenting

17 and this is why I say the intent here is,

18 should be stated. 

19 We can communicate with the

20 Secretary for a variety of reasons, you're

21 absolutely correct. But what we're saying

22 here is it's going to be our policy that we
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1 intend to provide an avenue specifically for

2 public input, that to the extent we feel it's

3 appropriate, to inform the Secretary of what

4 we have been hearing.

5 Now I'm going into history, and I

6 may not be exactly correct on this. But I

7 know, I was informed that in the early days of

8 the NOSB Board meetings, that it was not at

9 all uncommon for the Board at the end of the

10 meeting to draft a letter to the Secretary.

11 Now I'm not saying I know what was

12 in those letters or anything else, but I

13 understand that's what happened. I don't know

14 if anyone could fill me on this.

15 But the intent back then was

16 because this was a new program in formation,

17 et cetera, was to bring forward public

18 comment, and that was part of the statutory

19 authority, was to advise the Secretary on any

20 matter concerning the implementation of the

21 program. So that's why that was done a long

22 time ago.
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1 And Tracy, you had a concern too? 

2 I forget what.

3 MS. FAVRE: About public

4 communication with Board members outside of

5 meetings.

6 MR. MARAVELL: Right. So I don't,

7 you know. This is, this would cover

8 communications that we, you know, we've had

9 with the public, whether it's through a

10 working group or through a request for

11 information. It wouldn't have to just be at

12 this type of a meeting.

13 So I don't, I mean I don't think

14 this is a big deal personally, but maybe I'm

15 missing something here, that we're just saying

16 from time to time, we may want to inform the

17 Secretary of things that we have heard from

18 the public concerning the operation of the

19 program, and that's the way I interpret it.

20 CHAIRMAN FLAMM: Miles or Jenny,

21 do you want to make a comment or ask a

22 question?
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1 MS. TUCKER: Hi. A couple of

2 comments. This is Jenny Tucker. In terms of

3 the policy on communication with the

4 Secretary, the Secretary delegates authority

5 for the NOSB to the National Organic Program. 

6 So we would request that any letter that is

7 sent directly to the Secretary go through our

8 Designated Federal Officer, who is Michelle.

9 As an example, at the last Board

10 meeting, you passed the motion to send the

11 GMO-related letter to the Secretary. That was

12 submitted through the DFO and it was in the

13 Secretary's hands within 24 to 48 hours. So

14 that's an appropriate chain of command to

15 submit information to the Secretary.

16 On the second point related to the

17 public communications capability, a number of

18 questions have come up in terms of, for

19 example, email notification and will Board

20 members be able to respond. 

21 The motion here is you're -- would

22 be to state that you want this kind of
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1 capability to exist. The program would then

2 come back to you with an implementation plan,

3 in terms of here are the different tools that

4 could be used to accomplish that kind of goal,

5 and that would lead to an implementation and

6 rollout plan that would roll from a

7 recommendation you would make today.

8 But some of those answers have not

9 been answered yet. We have to decide first

10 that you want the capability.

11 CHAIRMAN FLAMM: I think Jay had

12 his hand up next, though. Thank you, Jenny.

13 MR. MARAVELL: Yes. I don't think

14 anybody has a problem with that, Jenny. But

15 I just want to say that we're both a National

16 Organic Standards Board and a federal advisory

17 committee or advisory board.

18 So we're just simply looking for

19 the way to provide our advice. So it would be 

20 -- our physical method of doing this is within

21 the constraints of the Department's policy. 

22 So I don't see a problem with any of that.
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1 CHAIRMAN FLAMM: Jay.

2 MR. FELDMAN: Well, the

3 Subcommittee discussed the issue of how this

4 wording should appear, and felt after

5 discussion that we should just repeat the

6 statutory language, and leave the

7 implementation, as Jenny mentioned, the

8 mechanics of how the thing gets delivered to

9 the program, but that the language in terms of

10 the direct communication, as indicated in the

11 statute, between the Board and the Secretary,

12 be preserved and memorialized in the PPM.

13 To answer John's earlier question,

14 you know, this grew out -- or John's statement

15 that this is a solution in search of a

16 problem: this actually grew out of a problem. 

17 As you recall, there was some interest on the

18 part of Board members to communicate with the

19 Secretary after the Seattle meeting.

20 There had been a, what, 50 or

21 some-odd comments on GMO issues, and it felt

22 like, to some Board members, the
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1 responsibility of the Board was to make the

2 Secretary aware that the Board had been

3 hearing from the organic community on this

4 issue.

5 So a one-paragraph letter was

6 drafted, and that then turned into a year-long

7 project. But there could be opportunities

8 here to keep the Secretary informed as to what

9 is being heard at the NOSB meetings, to the

10 extent that the Board comes together and feels

11 there is something important to report to the

12 Secretary.

13 So that's the intent here. In

14 some cases, that may be a year-long project,

15 to work something up. But in other cases, it

16 may be a simple note, hey, this is what we

17 heard at the meeting. We wanted to make you

18 aware that this, that we heard x number of

19 comments on this issue. It may affect your

20 thinking one way or another. Sort of a

21 factual communication that again, as Nick said

22 earlier, is intended to be constructive, and
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1 is intended to be helpful in terms of the

2 overall program, USDA meshing with what

3 happens here during the NOSB meetings.

4 So that was the intent, and it

5 grew out of a sense that there was a need for

6 this, and I personally believe the need may

7 exist at some point in the future, where the

8 Board feels it's necessary to bring that.

9 I don't see anything particularly

10 at this meeting where this arises, but the

11 authority we know is there, no matter who is

12 managing the program or who's sitting in the

13 Secretary's seat. It's just an ongoing, it

14 reaffirms the ongoing ability of the Board,

15 per the statute, to engage in that type of

16 communication.

17 CHAIRMAN FLAMM: Nick, I'll

18 recognize you in a minute. But I want to give

19 the lead person on this an opportunity to

20 speak, if she wants to. You are the writer. 

21 You ushered this through, and I think maybe

22 you should have the opportunity to answer
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1 questions.

2 MR. MARAVELL: Yes. I'd like to

3 just state my understanding of this so that

4 we're all clear. We're not talking about

5 providing recommendations to the Secretary

6 here, that would, you know, those go through

7 a different process.

8 This is primarily informational. 

9 There may be some advice in it. But we're not

10 providing recommendations under that type of 

11 authority.

12 The statute said we're authorized

13 to provide advice. So this is what I would

14 consider to be a lower-level type of

15 communication, rather than saying we recommend

16 this for the National List or something like

17 that.

18 CHAIRMAN FLAMM: Harold.

19 MR. AUSTIN: I guess to me, it

20 would appear that there's already a vehicle

21 and a means and a method in place right now. 

22 I think the process in the Board
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1 and the communication between the program and

2 the Secretary and the NOSB seems to have been

3 able to function in the past, or we wouldn't

4 probably be to where we are right now.

5 I think this does open up the

6 potential for issues. I don't think it's

7 clearly defined as what the vehicle will be or

8 who will deem it necessary. Is it the entire

9 Board that makes the decision on what

10 communication? It doesn't state that.

11 Is it, you know, are those issues

12 decided by a majority of the Board, or by

13 individuals of the Board. I think if we're

14 going to put something like this into the

15 Policy and Procedures Manual that's going to

16 replace what is in existence today, we need to

17 be a lot more clearer and a lot more specific

18 than what's on there right now.

19 I could not vote for this as it is

20 written right now.

21 CHAIRMAN FLAMM: Colehour, as

22 chair, I want to give you an opportunity to
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1 speak before we -- we're past recess time now,

2 so but would you -- you want to address the

3 concerns that some Board members have stated?

4 We have a motion, and we'll need

5 to either -- we need to either vote on it soon

6 or withdraw it, and that's your call.

7 MR. BONDERA: Yes, very good. 

8 Thank you. Like when I introduced this, I

9 will just remind the NOSB members that this is

10 nothing new, and this, in this form, has been

11 presented for quite some time. 

12 But I appreciate people's

13 responses nonetheless. I think it's relevant

14 to speak about it. I do also, however, want

15 to remind people what the program just told

16 us, which is that they understand that we're

17 seeking ways to achieve these goals, and their

18 understanding is they would work with the NOSB

19 to, like Harold just referred to, lay out the

20 specifics, because that is some of the

21 questions at hand, and I think it --

22 I acknowledge the fact that it
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1 does say executive director, and there are

2 other -- there's actually verbiage in the

3 statute that, as John alluded to, is a little

4 bit -- needs updating. But we're not in a

5 role to be playing those kinds of roles very

6 viably or in this context.

7 So that said, I would like to ask

8 you, Jennifer, if you would like for us to --

9 you know, you're the one that made the motion.

10 If you would like to withdraw this motion and

11 we can continue this discussion tomorrow, I

12 think that would be fine, and if you feel

13 otherwise, I'm willing to entertain continuing

14 with it at this moment. But I will ask you

15 that question.

16 MS. TAYLOR: Colehour, I'm hoping

17 that we will be able to go ahead and vote on

18 it. I believe it's been properly seconded,

19 the motion has. Yes. I'd like to continue

20 our vote, to vote on it, please.

21 CHAIRMAN FLAMM: There is a motion

22 that's been seconded on the floor, and we can
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1 proceed with a vote, if that's what you would

2 like to do. Any further comments or

3 discussion?

4 If not, we'll proceed with a vote,

5 beginning with Calvin.

6 MR. WALKER: Yes.

7 MR. BONDERA: Yes.

8 MS. TAYLOR: Yes.

9 MR. MARAVELL: Yes.

10 MR. FELDMAN: Yes.

11 MS. SONNABEND: Abstain.

12 MR. STONE: Yes sir.

13 MS. FULWIDER: No.

14 MR. AUSTIN: No.

15 MS. FAVRE: No.

16 MS. BECK: No.

17 MR. FOSTER: No.

18 MR. DICKSON: No.

19 MS. RICHARDSON: Yes.

20 CHAIRMAN FLAMM: And the chair

21 votes yes. Let's see what we have: 8 yes, 6

22 nos and one abstain. We have insufficient
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1 votes for the motion to pass, and it fails. 

2 That's the end of the session today. We'll

3 recess until eight o'clock tomorrow morning. 

4 Have a good evening, everyone.

5 (Whereupon, the above-entitled

6 matter went off the record at 5:47 p.m.)

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22
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A

AAP 17:2 24:12

71:15 232:10

234:1 255:17

Abbott 212:13

258:17

abbreviate 36:20

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238:17 348:1

352:20 392:14

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227:14 267:3

298:13 299:7

330:15 348:5

349:6 388:20

394:3 396:17

abnormal 179:5

abnormalities

128:7

above-entitled

98:16 237:4

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361:19 398:5

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281:16 353:9

385:21

absorption 74:16

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193:11

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79:2

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69:20

abused 112:9

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279:10

academicians

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Academy 4:22

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251:19 252:6

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307:10

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332:11 377:8

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261:15

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Accountability

107:15

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298:9

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245:14

Accusing 370:20

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306:1,1,4

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306:5

acknowledge

193:22 395:22

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153:2

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199:22

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238:8

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101:19 116:18

121:12 124:14

134:1 137:13

168:5 180:14

192:11 205:2

209:17 251:17

256:17 261:16

264:15 265:3

273:12,18 277:19

278:6 279:10

287:20 288:5

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380:2

added 8:5 9:7,20

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27:9,11,12 28:3,4

28:12 29:1,4,7

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48:1,1 50:21 51:6

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89:3 101:4 102:4

103:19,22 108:7

116:15 117:6,9

124:18 125:3

128:17 130:3

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153:5 154:15

156:4,8 157:8,16

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189:17 190:7

192:22 193:14,16

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240:2 251:13

252:4 284:17

285:2 293:11

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adding 80:7 124:10

160:9 234:5 275:2

303:12 346:4,22

378:9 379:5

addition 9:1 38:21

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60:15 63:6 75:15

78:10 108:20

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195:6 243:21

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94:6 96:10 109:15

115:22 132:16

133:13 159:18

179:17 182:1

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238:10 239:7

249:4 267:2

Additionally 345:9

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243:13 248:13,19

248:21 249:14

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395:2

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300:17

adequately 30:14
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379:14

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145:5,10

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199:20 240:16

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353:13 378:15

380:18,19 381:12

382:13,17,21

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391:19

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376:22

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113:10 138:21,22

143:1 170:6

205:11 232:10

271:8 290:11

294:4 320:13

368:6 373:22

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321:19 323:7

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187:16 309:21

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171:11 183:16,19

326:5 343:21

344:16 345:8

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334:20 366:16,22

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147:19 148:4

167:8,10

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135:17 317:22

318:8 334:14

336:21 338:20

342:15 380:11

alert 348:16,22,22

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Alimentarius 20:4

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Allen 143:17

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53:18

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336:10

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106:21 111:16

172:8,9 303:7

335:7 339:4

360:14

allowance 145:18

172:5 251:8

allowances 152:14

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115:12 117:4

118:2,6,12 119:11

120:12 147:8

154:2,13 166:5

170:5 171:16

173:2 185:11

186:12 229:15

254:22 265:12

270:3,11,22

309:17 354:6

allowing 41:19

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alluded 340:11

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Alphabetical 73:8

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274:21

carotenoid 36:21

175:1 177:8 180:6

214:3

carotenoids 174:15

174:18 175:3

177:11,17 214:4

214:14,22 215:11

carotenoid-suppl...

216:6

carrageenan

357:21 360:4

carried 153:20

157:20

carrier 159:11,12

carriers 156:2

carrots 14:4

CAS 40:19 262:9

264:15 265:3

276:5,13 277:19

278:6 284:16

285:1 286:10,15

287:20 288:5

312:1,7 313:13,18

case 9:3 16:12

55:17 95:4 154:22

165:9 172:21

173:9 189:17

195:15 202:7

264:11 299:15

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cause 199:3,16

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cautioned 141:21

caveat 161:3,12

CBI 94:1 184:9

CDC 108:14

Celestial 190:20

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cell 129:9

cells 180:10 181:16

Center 19:21 132:4

centered 319:14

centers 214:19

centralized 148:21

CEO 360:1

certain 151:4

172:18 180:10

200:6 207:6

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87:12 131:1 139:4

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certification 68:5,8

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certifying 172:22

173:7 174:1

cetera 150:19

151:1 158:5

164:18,18 386:17

CFR 46:3 117:5

139:18

chain 388:14

chair 4:7 11:16

12:8,10 17:19

263:7 269:5 273:7

274:19 277:15

282:19 284:11

286:1 287:15

289:3,6 293:7

295:20 301:1

303:1,2,2 311:10

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319:15 330:6

335:22 337:15

341:2 361:15

362:1,9 372:10

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394:22 397:20

Chairman 4:3 12:7

98:10 151:15

236:11,18 237:2

238:20 260:18

261:18,22 262:4,7

262:12 263:7,13

264:21 265:1

266:22 267:15,20

268:8,19 269:5,17

270:5,19 271:6

272:4,7,14 273:7

273:14,17,22

274:19 276:2,7,11

276:16 277:15

278:1,5 280:5

281:7,15,18 282:1

282:19 283:2,11

283:15 284:11,19

284:22 285:6

286:1,6,12,14,19

287:15 288:1,4,9

289:3,6,11,18,21

290:9,12,22 291:6

291:9,19 292:6,12

292:16,19 293:8

293:13,17 294:2,9

294:14,18 295:3

295:20 296:16

297:2,22 298:4

299:16 301:10

302:2 303:14

304:15,21 306:6

306:17 307:1,4

308:3,17 309:8

310:3,9 311:10,17

312:5,12 313:8,16

313:22 314:4

315:1,10 361:17

361:22 362:4

365:4,7,19 366:12

368:4,19 371:9

372:6,20 374:1,11

375:11,15,20

376:2,19 377:10

377:19 378:3

379:19,22 380:8

381:5,22 383:19

384:15 385:5

387:20 389:11

390:1 392:17

393:18 394:21

396:21 397:20

Chairperson 1:12

1:14

chairs 32:21

challenge 152:18

199:1 220:5

278:18 370:20

challenging 370:12

chamber 139:20,22

141:4

chance 96:12

199:14 228:12

236:20 355:10

change 49:11 80:3

80:9,18 81:2,3

91:11,16 159:19

220:16 251:1,3

275:21 322:10,18

325:1 326:12

358:4 365:9 367:3

369:4,16 370:8,17

374:8 384:12

changed 47:9

136:15 221:20

321:3 322:17,18

324:12 384:6

changes 81:15

99:21 259:18

332:7,8 333:20

350:17,20 351:2

354:4 362:17

374:5,11 375:12

375:12,21

changing 80:2

169:9 221:16

chapter 200:3

chapters 19:8

character 337:5

370:21

characteristic 23:9

23:9 183:20

characteristics 8:1

charged 301:7

Charlotte 100:3

105:10,13 111:15

112:21 115:5

cheat 150:16

check 11:18 205:8

348:15

checking 53:22

checks 359:15

chemical 23:13

108:15,15 109:5,6

120:14 185:2

275:20

chemicals 184:18

chicken 74:9

chief 18:3,18

child 134:17 136:4

136:8 138:13,22

194:15

children 132:3

135:21 136:1,16

255:10

child's 137:16

China 118:12

202:12 203:18

Chinese 204:1

chisel 321:5

choice 41:10 44:9

65:9 66:2 70:19

103:11 127:3

160:20 162:6

190:22 194:13

225:4 298:8

choices 65:11

choline 137:6,13,16

choose 66:3 72:11

116:13 203:8

226:4

chooses 127:1

224:21

choosing 40:9

chop 69:9 94:21

chore 220:21

chose 187:19

chosen 38:15 213:1

271:1 341:11

351:13

chuckle 137:5

circle 47:14 72:16

circulated 350:18

circulation 181:2

circumstance

115:13

circumstances

23:20 151:1

339:15 340:8

citation 267:17

citations 8:17

cited 130:15

citizen 100:13

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clarity 16:3 17:1

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class 23:3 172:9,17

classes 163:18

classic 256:2

classical 76:19

classification 40:14

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187:15 283:8,12

classify 39:10

188:4 262:8 263:9

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284:13 286:15

290:20 291:4,14

291:14 292:12,13

292:20 294:12,20

295:22 312:8,14

313:10

clause 89:6 298:9

clean 357:5

cleaned 89:20

cleaners 164:20

cleaning 88:6

385:10

clear 9:8 10:11

16:8 47:22 79:5

84:21 85:17 89:15

101:17 102:11

111:6 114:2

131:17 148:9

152:12 169:1,1

170:12 188:5

235:20 265:9

276:19,20 290:7

291:13 293:18

298:6 341:12

354:10 371:16

383:6,9 393:4

cleared 295:4

303:16

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clearing 187:9

clearly 85:2 90:21

96:18 110:5

212:20 259:12

337:18 360:9

366:20 367:4

371:19 382:3,11

394:7

cleaved 27:16

clinical 63:19 96:6

176:12 197:21

219:14 230:1

246:18

clinically 26:5 69:6

95:15

clock 92:8

close 92:1 137:18

140:18 226:20

closed 358:15

closely 49:5 170:3

220:4 335:22

337:14 375:8

closer 128:21

closing 337:10

375:4

cluster 15:5

coatings 147:16

Cockram 208:7

212:10,12,13

216:15,18 217:1,5

218:4,7,18 219:1

220:9 222:19

Code 43:17 101:16

Codex 20:4 118:12

119:10

codified 197:2

266:5

codify 89:2

coffee 292:3 294:7

cognition 176:9

cognitive 128:12

176:14 177:5

cohesion 280:2

COI 93:18 94:1,2

317:8 350:18

351:8 353:19

354:6

Colehour 1:16

132:16 272:9,10

297:22 298:4

315:15 319:2,15

332:8 342:19

349:11 362:4

365:7,16,17

368:19 371:9

372:7 374:1,2

375:12 376:21

377:6 394:21

396:16

colic 69:19 112:7

112:10

collaborator

332:18

colleague 150:9

colleagues 204:21

233:14

collected 155:14

collective 214:4

college 17:22 18:4

18:16,21 91:10

colonization 33:17

colony-forming

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color 14:4,11 52:12

159:15 351:1

colored 322:17

coloring 258:13

colors 159:13 214:2

colostrum 215:2

columns 89:2

combination 30:12

117:14 146:14

225:17 317:15

combinations

120:3 124:17

combined 191:4

290:5

come 17:7,14 22:6

24:15 53:9 54:18

70:3 71:10 128:7

151:5 153:17

158:11,18 199:9

202:5 204:22

218:14 222:2

243:16 249:2

255:8 280:18

304:22 320:8

331:10 332:21

371:13 388:18

389:2

comes 16:13 160:5

176:2,7 179:12

180:4 209:4 241:6

249:8 265:12

333:14 391:10

comfortable 35:9

35:13 148:18

188:3 366:2

coming 4:14 7:16

7:20 80:9 81:2

88:18 99:19 130:6

151:11 169:9

180:12 181:13

187:8,20 238:4

343:7 374:3

comma 374:16,16

375:2,4,6

command 388:14

commas 368:12

commencing

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comment 5:4 6:21

7:1,4 14:19,21

24:3 25:16 36:10

36:11,13 41:14

46:1 52:19,22

56:19,21 59:9

64:7 73:21 77:9

78:18 81:4 82:15

83:13 99:11

104:22 169:2,20

186:17 220:18

221:13 235:16

281:19 290:15

304:3 308:4 317:8

318:5 320:16,16

322:6 333:12

334:17,22 335:1,5

335:16,18 336:11

336:14,17,19

337:3,9 338:21

339:5 344:9 347:4

347:20 350:4,22

353:18 354:19

359:2 360:13

362:13 364:4

366:8 369:3

374:15,15 375:2

379:9 381:22

383:20 386:18

387:21

commentary 339:4

commented 46:3

110:6

commenter 139:7

194:21 216:13

230:7

commenters 3:17

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87:21 89:10 91:19

145:14 191:15

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Commission

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20:11 38:12 40:13

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70:11 71:6 75:14

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138:21 222:2

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261:1 264:11

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331:9 344:2,6

350:10 353:14

362:5 389:17

committees 20:4

committee's 106:12

170:7

common 63:1,10

174:22 179:1

commonly 117:8

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communicate

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347:22 362:14

377:8 378:12

384:21 387:8

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community 18:11

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94:18 106:6

110:22 243:22

250:14 270:14

278:19 279:11

300:6 321:2

323:16 324:2

326:4 332:3 343:6

344:1,13 345:11

345:17,18 348:6

359:4 391:3

community's 348:2

community-based

331:16

company 170:1

190:10,21 191:2

195:13 218:15,20

241:6 245:9

compared 44:8

65:12 147:18

198:16

compelling 180:16

competitive 198:16

compile 91:2

compiled 82:21

complaint 290:15

complementary

134:15

complete 85:22

126:19 129:22

135:6 172:20

173:12 198:7

225:9,21 226:6

232:4

completed 18:2

103:12

completely 65:13

120:14

completes 315:4

complex 121:17

124:14,16

complexity 333:6

compliance 161:13

167:15 253:8,16

253:17 266:12,19

266:21

complicated 23:13

82:3 91:21 98:2

251:1 299:18

318:15

complications

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complies 84:7

162:10 213:2

complimentary

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comply 148:4

162:5

complying 240:13

component 127:8

132:14 135:2

153:8 154:16

155:12 197:17

components 24:20

43:8 94:22 101:6

102:5 126:11

127:5 134:16

218:17

composition 213:3

226:22 228:4

246:16

compositional

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compound 24:17

57:5 242:18 244:8

compounded 156:4

compounds 22:11

22:22 23:4 25:9

79:1 214:6 280:22

comprehensible

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comprised 147:12

comprises 37:10

concentrate 67:20

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214:16 215:22

301:19 302:7

concentrating

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concentration

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concentrations

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217:14

concept 94:9

340:17 371:20

concern 66:5 69:21

70:6 88:12 89:5

202:15 355:18

356:1 385:13

387:1

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46:21 88:10 94:18

96:3 100:11

122:11 134:21

230:13 357:13

concerning 26:2

343:22 386:20

387:18

concerns 44:2

50:22 61:9 69:18

77:1 87:22 88:7

96:3 301:22

337:22 350:21

351:1 385:8 395:3

conclude 227:5

concluded 103:17

concludes 235:16

conclusion 70:3

128:8 129:21

156:10,11 159:22

160:13,14 186:5

conclusions 126:13

conclusory 298:8

concur 77:3

condenses 209:11

conditions 23:11

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conduct 4:8 162:17

163:6 165:1

171:14

conducted 163:15

conducting 226:13

conference 81:20

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Congress 47:8

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Congressional 47:3

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consideration 29:6

50:1,2,4,4 85:5

228:7 336:19

considered 39:6,6

55:22 81:1 85:21

96:14 112:14,18

120:16 121:19

154:20 156:2

183:7 184:11

196:21 199:19

211:11 219:20

234:1,14 235:3

240:15 255:12

300:17 337:13

375:7

considering 22:11

89:14 115:2 145:5

268:2 361:5 364:2

372:16

consistent 44:16

145:20 146:3

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170:12 186:6

187:2

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consolidated 186:4

constantly 226:14

constituencies

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constituency's

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constitute 360:8

constitutes 104:8

constraints 389:21

construction 44:1

constructive

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346:9 378:15

380:18 381:12

382:17 391:22

consult 50:7 248:12

consulting 10:1

249:13

consume 154:12

consumer 7:17

54:7 60:5 84:8

100:11 103:16

104:12 109:17

111:5,10 160:19

160:20

consumers 60:6

68:6 76:2 102:13

103:7 104:19

110:1,4 114:18

198:12 210:9

232:15,22 233:2

359:11

consumer's 157:10

consuming 100:17

121:15 215:9

consumption

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contact 360:3

contain 42:18

53:11 57:11 85:18

86:1 103:3 136:17

167:19 168:14

214:14

contained 152:20

271:10

contains 110:13

111:11 114:19

119:16,17 178:12

191:16 201:18

contaminated

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contemporary

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content 59:18 63:8

118:17,19 214:3

215:3 316:12

context 48:4

238:22 239:8

252:22 396:6

contexts 68:1

contextual 224:10

continue 98:13

134:9 136:22

155:22 266:4

311:13 384:9

396:11,19

continued 223:21

continuing 369:5

396:13

continuously

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continuum 209:15

contract 192:20

contractors 358:19

contracts 358:7

contradicting

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control 358:1

controlled 355:14

convened 1:10

255:16

convenience 149:9

conventional 44:12

75:3 107:1 110:14

160:3,6,8 161:8

232:5 255:3

298:22 300:8

304:14 305:11

conversation 264:1

conversations

12:18 16:21 59:22

99:2

convince 221:9

convinced 79:10

Cool 206:11

Coop 356:21

cooperation 90:10

cooperative 103:15

copies 335:10

copy 144:2 377:14

377:16

Cordon 350:14

corner 280:17

Cornucopia 100:9

100:21 105:14

146:17 322:19

357:8,9

corporate 324:22

325:3,5,11 359:9

corporation 359:18

correct 28:16 29:8

46:6 96:13 113:18

191:13 195:8

197:6 218:18

261:22 264:8,13

272:13 356:19

385:15,16,21

386:6

corrected 104:10

349:20 373:1

Correction 297:4

correctly 90:18

270:10

cortex 215:20

cost 33:13

Council 6:12 13:18

52:5 56:9 58:21

73:12 76:3 78:5

223:3

counsel 343:2

350:9

count 311:11

counted 99:13

counter 66:18

counterparts 160:3

counterpoint 161:8

countries 112:4

country 103:15

counts 33:6

couple 41:3 61:18

164:10 228:18

239:7 315:21

354:4 388:1

couples 129:8

course 89:17

110:21 137:3

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court 167:6,16

courtesy 12:2

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criticized 107:13

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crucial 209:3

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331:6 354:5

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fascinating 238:12

fashion 41:5

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295:6 296:7

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313:6,21 314:18

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118:11 119:10

122:11 130:14

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239:20 242:10,11

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first 5:20 6:9 7:9

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73:5 76:5 88:8

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59:19 60:1,15,17

61:6 62:19 63:7

63:12,16 65:21

66:10,13 69:13,21

70:13,17 71:5

72:10 73:12,15

74:15 75:2,4,7

76:3,15 78:5

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97:9 106:22

107:10 108:6,7,18

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112:13 114:12,14

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116:19 117:10,22

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126:17 127:3,13

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194:15,19 195:7

196:22 197:1,14

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311:16,19 312:16

314:20 366:14

367:10 369:20

370:1 371:15

376:17 382:1

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38:4 42:14 74:8

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frankly 103:9

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185:18 241:9

fresh 342:16

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full 96:20 97:5

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172:20 259:20

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issuance 266:13

issue 24:16 33:14

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issues 11:12 19:2

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45:2 67:3,22

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italics 378:9 379:6

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items 85:9,11 86:16

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iterations 319:17

it'll 316:7

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Jenny 387:20 388:2

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keeps 140:17 361:5

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kept 149:11 254:11

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key 156:14 255:21

kid 122:3

kind 10:19 11:18

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303:18,18 304:2

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339:8,17,22 340:2

340:13,15,21

341:1,4,5,11

342:1 354:1,20,22

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358:2 363:5,13

364:6,9,14 366:7

367:5,17 368:15

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knowledgeable

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Labeling 48:21

Laboratory 174:16

lack 70:12 76:1

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Lane 125:21

language 83:11

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largely 159:3

larger 307:16

largest 103:14

Lastly 212:3

late 76:19 349:14

latest 66:11

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lawyer 169:4

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liked 327:12

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lines 9:16 54:6

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lipid 15:18

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lipofuscin 178:6

liquid 33:13

Lisa 2:16 4:19 6:6

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list 5:22 6:15 11:6,8

13:21 14:1 16:4

16:15,18 36:2

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150:16 153:4,5,8

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156:6,9 158:7,14

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161:19 162:1,2,18

163:12 164:6

165:13 167:4,12

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171:3 172:20

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185:21 188:18

192:12 193:6

197:1,6 209:21

210:1,21 211:14

234:14 250:9

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261:17 263:11

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273:10 274:21

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277:20 278:7

281:1 282:21

284:18 285:3

286:4 287:17,21

288:6 289:8,16,22

290:17 291:17,22

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309:13,15,18

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313:18 315:3

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43:17 75:5,8

118:9 145:1

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live 210:22 341:22

342:1 349:16

liver 181:19

lives 199:12

livestock 165:9,15

living 208:17

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LLC 35:22

LMP 186:2

lobby 169:15

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lobbying 360:7

lobbyist 357:9

local 202:14

locally 205:5

located 356:22

location 116:10

logic 363:17

long 8:22 13:1 82:3

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Louisiana 327:1

love 82:4 154:12

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lucky 17:16

lunch 5:6 99:8

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lutein 35:7,18,20

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42:12,14,18,19

43:22 44:21 45:10

51:22 55:22

106:14,21 174:20

174:22 175:7,15

175:20 176:1,3,8

176:14,17 177:2,4

177:5,9,12,18,20

178:2,3,10,13,13

178:14,21 179:8,9

179:12 180:9,14

181:11 182:13,17

183:15 184:2

185:18 186:22

189:18,20 190:5,5

213:16 214:7,12

214:19 215:3,4,8

215:13,21 216:2

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lutein-deficient

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lycopene 41:4

47:16 52:1,3,6,9

52:11,13,18 53:6

53:9,21 54:2,3,13

55:3,12 56:1

106:13,22 177:10

213:16 214:7,13

218:21 219:3

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L-carnitine 56:5,7

56:10 57:2 58:11

58:13 61:19 62:4

130:17,20 131:4

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195:5 286:10,15

287:20 288:5

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L-lysine 62:14

L-methionine 58:1

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60:21 61:13,19

62:6,13,21 63:2,3

108:5 114:11,14

114:20 130:14,16

130:21 192:2,7,11

289:10,11,16,22

291:4,14,18

292:11,20 293:1,2

293:3 294:12

295:22 296:8,10

296:18 297:5

299:1

L-methionine's

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257:18 285:8

316:22 365:20

macronutrients

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macula 181:11

macular 37:10

181:8

Madam 140:21

Mahalo 342:8

mailing 375:6

maintain 151:6

321:20 347:9

379:14

maintained 88:9

maintaining 142:8

316:12

maintains 8:8

266:6,16

major 143:14

177:8 181:6 199:1

200:11 210:11

220:21 336:18

majority 87:20

154:14 210:6

394:12

maker 372:7

makers 212:14

make-up 53:20

making 19:16 33:4

48:7 83:19 116:9

234:7 302:3

319:13 356:4

384:10

malaria 26:17

maltodextrin

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manager 356:20

357:4

managing 392:12

mandate 47:4

mandated 39:20

79:18 116:15

297:12

mandatory 44:9

207:10 244:20

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manual 316:13

317:18 321:12

324:7,21 326:10

326:11 331:20

334:16 342:14

343:8,18 346:2,21

347:6 348:10

364:19 365:10

371:21 380:2

384:4,12 394:15

manufacture

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228:17

manufactured 48:4

95:22 254:12

manufacturer 46:3

48:10 63:14 133:9

135:13 158:21

221:4,6 231:4

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249:8 258:2 259:2

manufacturers

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60:6 85:20 107:11

116:17 133:11

163:9 208:22

219:2 223:4 227:6

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230:14 231:15

233:20 243:15,15

243:16 248:19

251:17 275:7

manufactures

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manufacturing 8:7

9:17 24:22 25:5

31:14 32:5 60:10

61:9 63:15 76:4

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marigold 183:17

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mark 188:22

market 49:10 69:4

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240:11 241:8,10

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marketed 302:21

marketers 223:5

Marketing 1:1 2:18

marketplace

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markets 103:14

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Marnie 349:18

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Marsha 222:22

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Marsha's 235:15

Martech 264:5

Martek 359:22

Maryland 20:8

massive 104:9

Master's 20:18

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match 193:15

material 7:8 35:18

36:22 38:9 39:14

41:6 55:9 68:18

68:19 108:4,12

152:16 156:8,9

185:3,6 187:17

195:4 196:18,19

261:7 263:9,14

268:9 269:9 272:9

277:17 282:22

283:5,9,13 287:17

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materials 4:15,16

5:8,15,22 6:2

21:14,20 24:6

29:11 35:6,11

41:3 43:9 44:2

47:14 48:1 83:2

86:2 90:6 91:15

92:12 93:22 97:4

97:6 102:8 115:19

125:6 133:16

144:14,20 147:13

150:18 151:4,22

153:19 154:8

161:18 185:1

228:12 261:2

263:17 279:10,22

300:16 311:14

maternal 208:19

224:16 225:2

matrices 23:17,18

matrix 24:2

matter 47:3 98:17

102:18 130:22

162:7 237:5 259:2

260:14 266:14

315:8 341:17

361:20 386:20

392:11 398:6

maturation 129:2

131:1,20

matures 131:6

maximize 366:8

maximum 335:20

McEVOY 2:10

meager 147:18

mean 81:2 114:13

160:6 168:18

181:4 186:14

189:14 206:4

218:2,8 253:17,18

279:5 291:14

327:14 367:6

370:13,15 371:4,7

372:2 380:17

387:13

meaning 153:12

means 31:19 92:19

100:14 126:21

205:22 258:8

267:9 301:4

369:13 370:5,6

380:18 385:1

393:21

measure 216:9

measures 24:19

meat 57:8

mechanics 390:8

mechanism 86:8

347:10 379:15

384:18

mechanisms 23:19

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medical 17:22 18:4

18:9,16,21 42:11

77:15 112:14,18

114:6,7 135:14,19

136:9,12 138:5,5

138:7 139:1

medically 135:21

Medicine 18:11,20

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250:17

meet 19:17 48:12

127:4 137:16

192:7 193:3

236:12 240:22

meeting 1:4 4:4

6:22 52:20 56:19

61:4 78:19 82:9

94:4 106:3,4

118:18 135:17

136:21 137:7

152:3 195:4 226:2

239:10 317:12

318:7,8 321:4

326:19,19 329:9

330:11,19 334:14

335:3,11 336:1,21

337:11,12 338:21

338:21 339:17,19

341:14 344:3

348:13 350:16,18

357:21 374:18

375:4,5 385:4

386:10 387:12

388:10 390:19

391:17 392:10

meetings 60:14

155:5 260:5

317:22 330:5

334:2,18 335:1

339:8 344:6 345:8

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374:15 378:18

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387:5 391:9 392:3

meets 28:13 301:6

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MELISSA 2:14

member 5:2 19:11

100:9 316:14

319:20 327:18

328:4 344:4

351:18 352:1

357:8,19 360:5,22

380:3

members 1:13 4:5

5:21 21:2 75:22

86:17,18 99:9

151:20 233:14

238:17 315:10

316:5,21,21 320:3

321:13 324:10

325:16,19 328:2

329:16 330:7,7

335:7 337:17,21

338:13 343:5

348:5,14 349:3

353:6,11 355:20

357:3,6,14 360:3

360:7,17 363:1,12

385:2 387:4

388:20 390:18,22

395:3,9

member's 352:14

memorialized

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memory 214:20

menstrual 95:13

mental 128:12

mention 41:1,2

99:8 142:14

256:20

mentioned 39:8

41:17 70:15 90:12

118:4 122:12

134:12 180:21

200:1 206:15

233:18 319:4,16

320:9 332:8 369:8

384:22 390:7

meshing 392:2

met 141:7 225:16

367:2

metabolic 44:4

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metabolism 129:8

meter 143:11

methionine 57:7,18

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methodology

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Mexico 317:22

319:4 321:3

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Miars 139:13 144:7

144:9,12,13 149:2

149:13 150:7

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mic 156:10

Michael 323:12

Michelle 2:12

41:11 82:20 99:20

144:9 315:19

322:4,11 364:6

366:3 388:8

microayalgae 40:7

microbiological

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microbiologically

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micrograms 190:8

microphone 315:18

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mics 32:21

middle 209:22

279:15

Miles 2:10 387:20

milestone 141:18

milk 31:18 37:18

37:19 38:2,5

42:15,17 51:5,11

57:14,15 64:14

66:4 116:11 117:8

125:1 126:17,20

127:12,13 129:22

134:1,4,10 157:18

157:19,22 158:2

178:12 185:19

186:22,22 191:2

192:13 193:6,9,15

208:13 211:3

213:6 215:1,2

224:5,15 225:17

225:22 226:21

227:1 228:5

232:11 242:1

milk-based 75:4

129:15 133:21

193:1,17 231:12

milk-fed 215:14

milligrams 129:18

million 210:13

Mills 359:17

mimic 31:18 117:7

mimicked 83:12

mind 41:12 87:3

92:15 141:15

144:3 279:22

322:11 327:14

mindful 51:20

203:5

mineral 74:5

251:12

minerals 165:7,8

165:14,20 217:11

217:17 265:20

267:18

minimal 42:18 70:6

183:18 258:22

259:3

minimum 60:16

193:3 213:9 251:5

258:10 259:3

335:20

minority 26:13

minute 57:17 81:15

98:11 99:21 185:9

259:16 316:7

337:11 353:3

375:5 392:18

minutes 58:15 92:9

97:16 98:12 99:12

166:22 216:13,16

216:19 315:6

329:21 335:19,21

340:15,16 354:22

357:1 361:18

366:10

misbranded 199:21

Miscellaneous

346:3 378:8 379:4

misinformation

191:13

misinterpreting

270:18

mislead 114:18

misleading 110:18

misled 264:12

misplaced 101:1

misreported 253:1

missed 132:20

164:17

missing 113:13

358:8 387:15

mission 343:10,19

344:14 382:2,2

mistake 141:11

misunderstanding

351:21

misunderstands

353:7

misunderstood

299:10

mis-hear 206:18

mitochondria

129:11

mixed 131:2

134:22

mixture 25:4 45:11

mixtures 23:15

mix-ups 295:1

model 70:1 96:4

models 69:10 95:2

moderating 188:21

modified 49:15

104:5 333:17

339:2

modify 5:5 374:7

modus 336:22

molecules 211:3

moment 21:14

32:12 58:13

293:16 342:8

355:2 396:14

mom's 215:1

monkeys 179:3

180:5

monomers 128:15

month 215:5

months 34:10,11

71:9,11,13,18

72:2,3,5,8,8

120:22 121:1

122:18 126:16

134:20 194:7

199:12 215:18

225:13 255:19

moonwalked

323:13

morning 4:3,6,17

6:9 7:5,10 14:21

17:12 22:7,8

36:14 52:22 56:21

60:2 77:12 99:1

105:12 112:3,18

126:1 135:10

139:16 144:12

151:15 174:13,20

182:7,20 196:13

223:1 250:3 261:6

303:15,21 304:6

398:3

morphological

179:5

mortality 26:8

mother 37:21

110:9 126:22

194:15 224:20

mothers 191:1

224:22 226:3

232:15

mother's 225:4

motion 11:6 16:17

40:14,16 60:20,22

61:5 80:3,6 261:7

261:19,20,21

262:2,7 263:9,10

263:14,17 264:14

264:15,20 265:2,2

268:1 269:8,10,11

269:13,17 272:8

272:12,12 273:8

273:10,12 274:20

275:6,22 276:3,4

276:10,11,18

277:17 278:4,6

282:4,21 283:7

284:13,14 285:1,4

285:7 286:3,8,10

286:13 287:17,19

288:3 289:8,13,15

289:21 290:6,7,20

291:4,12,13,17

292:2,10 293:21

294:11,20 296:2,5

296:7,15,17 297:4

297:8,9 300:11,22

302:8 308:20

310:13,16 311:12

311:20,22,22

312:4,6,7,14

313:11,12,13,16

313:20,21 314:1,2

314:5,6 315:3

363:11 364:10,12

364:18,21 365:1,9

365:17 371:12

372:8 374:4,7

375:19 377:3,7

379:20 388:10,21

395:4 396:9,10,19

396:21 398:1

motions 80:2

261:14,16 292:4

293:10,16 294:1

motion's 375:16,16

motivation 301:15

motor 193:12

move 5:13,20 22:4

35:11 47:16 52:1

56:5 58:16 72:19

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moving 47:12

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MROs 152:17

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much-improved

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multi 153:7

multiple 23:16

85:18 86:11

167:19 204:11

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multi-component

154:21 155:13,15

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multi-ingredient

153:7

N

N 3:8 238:1,1,1

name 100:5,8

105:13 116:6

144:12 151:16

154:2 169:20

182:8 190:19

196:13 208:8

223:2 350:4

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named 18:18 140:7

names 336:13

name's 212:12

naming 84:2

napping 139:18

NARC 322:19

narrowing 309:1,7

Nation 319:12

National 1:2,4,10

2:10,15,16 6:15

13:20 14:1 19:5

36:1 40:17 43:1

52:7,10 54:21

55:18 56:11 58:11

59:1 73:14 75:16

76:9,11 78:8,11

79:15,16,22 83:17

84:1,5,10,11,20

85:2,8,9,21 86:12

86:16 89:9,20

101:14,20 102:6

104:15 153:4,5,8

154:6,8,15,18

156:6,9 158:7

161:19 162:1,18

163:11 165:13

167:4,12,22 168:4

168:6,18,19 170:5

182:14 192:12

193:6 209:21

210:1,21 211:14

250:18 251:19

252:6 261:17

264:16 265:4,20

275:2 277:20

278:7 281:1

284:17 285:3

287:21 288:6

309:13,15,18

313:14,18 341:9

342:22 343:22

345:4 346:8

378:14 381:19

388:5 389:15

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nationally 19:10

227:12

natural 38:18 43:4

53:9 100:15

103:14,19 104:21

109:14 110:20

111:3,8,11 118:5

137:12,15 139:15

153:10 156:1

159:3,6,9 166:4

173:9 177:16

naturally 37:4

nature 10:14 94:13

173:5 175:4

Nature's 135:13

nearly 74:10

139:18 350:9

necessarily 133:1

304:7 370:17

necessary 30:5

31:13 62:8 112:6

112:12 184:17

197:7 209:5 210:2

210:20 276:19

331:11 345:7

346:11 378:17

392:8 394:8

necessity 74:21

76:6 344:21

need 5:7 10:15 12:1

13:2,7 21:19,20

23:20 32:4 38:3

42:7 51:14 54:9

54:18 66:15,20

68:20 70:16 71:12

93:18 96:16 99:22

112:3 114:7 115:3

137:13 138:5

139:1 143:1

154:18,22 155:9

160:5 163:13

166:11,19 197:12

202:1 209:5

211:19 222:6

223:11 227:20

230:14 234:5,8,16

235:4,6,18,21

236:2,5,6 239:12

259:11,19 261:18

283:16 288:10

291:16 292:3,6

302:8,16 307:8

320:11 325:9

329:21 330:12

335:9 340:7 372:4

377:10,11 380:5

382:11 392:5,6

394:16 395:4,5

needed 5:5 26:1

137:16 156:5,7

193:9 194:11,16

250:15 359:6,14

needing 16:2

143:21

needs 23:12 104:10

110:10 115:1

127:4 137:17

155:7,8 165:12

168:5 169:5 181:3

193:14 211:18

225:16 226:3

232:18 234:19

240:22 241:1,1

360:9 396:4

negatives 160:15

neglected 256:20

neither 63:14 74:5

244:18 270:10

neonatal 18:19

19:2,3 65:3

neonate 25:1

neonatology 18:5

18:18 63:20

neural 42:8,13

176:1 181:5

215:19 216:7

neurotoxic 106:16

never 41:12 84:22

97:5 120:13

123:11,15,21

140:11 141:16

153:15 161:15

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247:19 264:3

298:10,17 306:14

nevermore 140:19

141:6 142:2

new 6:18 42:6 49:7

49:10,14,19 50:9

51:10 66:17 76:22

112:16 116:18

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188:18 205:3

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248:1,6,12 249:1

249:11 265:21

266:1 292:6

316:13 317:22

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326:18 328:5,12

334:18 342:14,17

346:4,22 354:6,8

362:21 367:13

375:16 378:9

379:5 386:16

395:10

news 154:4

nice 178:18 227:14

Nicely 105:1

NICHOLAS 1:19

Nick 7:7 13:6,12

15:3 28:20 32:10

33:22 34:15 53:2

55:2 121:8 122:14

149:20 150:12

159:18 203:11,15

231:6 259:9 261:9

267:20 271:6

276:22 283:6

368:4 381:6 385:5

391:21 392:17

nickname 91:14

Nick's 203:11

NIEHS 70:2 95:19

night 26:7

NIH 255:16,16

nine 337:7 366:17

366:22 368:17

369:5,6,9,11

373:12,17 374:8

374:19 375:10

nitrogen 30:19

nobody's 217:2

nodded 139:18

non 37:7 39:6 40:1

40:5 45:15 84:8

84:12 138:16

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non-essential 43:16

non-infant 80:11

non-listed 197:13

non-organic

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non-synthetic 41:7

45:5 58:7 79:12

79:15,17,21 81:1

96:21 156:7 166:4

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non-synthetically

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NOP 1:2 6:20

14:18 36:8 56:18

59:8 73:20 78:17

88:9,12 148:1,22

160:1 171:1 192:1

223:9 265:10

317:16 321:22

323:4 326:5,17

327:15 331:11

335:21 337:14

345:14 347:12

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normal 128:9

180:8,8 240:16

normally 29:1 38:4

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nos 397:22

NOSB 1:5 43:6,10

90:2 101:14

102:19,22 106:3

107:15 145:12

146:3 148:1,6

153:19 154:20

155:5,21 168:5

170:3 171:12

172:2,14,19 173:5

173:12,18,22

184:22 192:10

196:17 223:8

224:11 225:5

316:10,13 317:17

321:21 323:3

325:16,19 326:11

326:18 328:21

332:15 334:1,17

334:17,22 335:7

335:22 337:7,15

337:20 338:13

339:10 341:14

342:2 343:11,19

344:7 346:4 347:1

347:2,3,12 348:1

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350:16 351:4

352:16 353:16

355:15,20 357:4

357:22 359:16

360:3 363:1,12

374:15 375:1,8

378:9 379:6,7,8

379:17 380:21

385:2 386:8 388:5

391:9 392:3 394:2

395:9,18

NOSBs 86:14

87:15

nose 136:3

notable 339:14

notably 333:16

338:6

note 7:14 106:20

173:18 198:1

281:9 318:4

330:22 358:7

391:16

noted 9:2 215:21

notes 82:2

notice 63:7 220:18

244:5,12,20

245:19 248:20

249:5,9 256:19

291:7 305:1 335:3

335:6 337:11

374:18 375:4

notification 49:9

49:16,17 50:15

118:7 163:5

197:15 213:4

235:8 240:11,19

241:7 244:19

248:1,3,11 249:3

249:7,10 252:14

252:16 256:18

257:3 388:19

notifications 239:2

241:4 248:15

notifier 246:3

noting 338:9

339:11 340:11

November 35:20

56:8 329:13

no's 263:8 269:7

273:8 274:20

282:21 289:7,8

295:21 311:11

315:2

nucleotides 72:19

78:1,3,6,10,22

79:7,11,18,22

80:11,15 81:7,11

126:12 128:15,17

130:2 261:3

number 19:11,15

21:4,6 22:12

38:10,11 79:9

87:4 99:13 164:5

212:21 214:5

238:21 293:16

307:13 326:16

328:7,19 335:4,12

335:17 336:10,12

336:15,17 337:2,7

337:17 362:20,20

366:15,17,20,22

367:3 368:17

369:5,6,9,10,10

369:11,12 373:12

373:12,17 374:8,8

374:19,20,22

375:9,10 388:17

391:18

numbered 365:12

numeral 377:18

numerous 19:14

41:19,20 102:2

198:3 358:10

nursing 212:21

nutrient 10:4 43:11

43:12,15 51:4,10

64:1 75:2 76:12

118:16 119:2

129:2 132:11

135:1 136:6 183:4

197:4,13,17,18

200:6 209:12

221:19 227:13

230:21 234:13

240:9 254:21

255:7 256:12

265:20

nutrients 39:2 48:2

50:21 55:13,16

76:15 130:2,7

137:1 139:2

191:10 193:21

194:1,11,16,18

197:2 198:2,4,8

199:16,22 200:15

202:21 207:15

208:11 211:1

212:2 213:11,14

213:20 221:7

223:21 224:7

225:15 229:9

250:12,21 251:4

252:1 256:10

258:9,10 259:1

266:2 278:20

nutrition 17:21

18:6 19:3,4,13,22

20:4,14,17,20

46:21 48:21 62:16

63:20 66:6 69:13

70:4,11 71:7

74:22 105:17

106:10 116:20

118:18 126:4,6,7

126:8,10,18,22

128:5 133:8,9

134:21 135:5,12

136:7,11 138:22

176:7 180:12

191:7 194:14

197:10,12 208:20

209:2 212:13,15

213:12,15 214:11

214:11 223:5

224:16 225:9

226:10 228:1,4

250:14 251:20

256:2

nutritional 15:20

42:11 116:16

118:16 119:21

127:4 132:3

135:14,19 136:5,9

136:12 137:16

139:1 198:6

208:20 212:18

226:3,15 241:1

nutritionally

135:21 160:2

198:10 226:6,20

232:4

Nutritionals 116:5

116:8

nutritionist 190:20

208:9

nutritious 232:7,12

nuts 156:12

nutshell 147:1

244:22

O

O 238:1,1,1

object 329:4

objection 13:5

objections 322:21

objective 356:4

obligate 116:17

obligated 221:8

obligations 344:3

obstacle 93:16

obtain 85:22
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221:5 228:20

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occasion 220:10

occur 199:15 254:9

occurs 29:22 31:4,5

65:3 185:3

octameter 143:12

October 1:8 13:17

58:20 140:3

ocular 51:7

oddly 281:2

offer 116:11 146:19

offers 191:2

office 20:6,10 48:21

48:22 49:2 50:7

50:11 98:21

107:15 192:20

243:13 248:13,20

248:22 249:13

Officer 341:13

388:8

offices 48:20 49:4

official 352:15,17

355:3,4

officials 351:7

OFPA 83:3,10,15

83:18 84:16,18,21

85:2,10,19 153:4

161:13,18,22

167:20 168:5

200:2 206:5

oh 45:17 73:3 99:13

156:11 189:5

203:2 218:13

239:3 246:14

259:21 290:18,22

297:2 310:9

331:21

oil 118:5

oils 8:5 29:20

257:21

okay 12:6 22:20

25:7 28:10 29:13

30:4 32:17,20

36:18 41:12,14

53:5 64:4,8,8 67:6

71:2 73:3,6 81:10

82:2 86:13 88:7

90:18 96:12 97:14

139:9 142:19

144:4,5 150:11

151:14 157:3

166:20 167:1

201:15 203:11

204:15,16 206:12

217:19 218:19

222:17 235:15

236:16,21 238:15

238:19 239:14

242:13 245:22

246:8,22 247:3

254:20 259:11

262:1 267:19,19

275:4 277:18

289:5 291:10,20

292:16,19 294:3,9

294:14,15,20

296:17 297:3,8

305:6 307:1,6,21

307:22 308:2,3,5

308:18 310:10,11

310:15 311:16,17

312:5 324:18

328:7 330:4

342:20,21 343:15

343:16 356:15

369:21 374:1

383:22

old 46:21 225:13

254:15 279:6

older 136:16

oleoresin 184:16

Omega 104:2

OMRI 81:5 144:14

144:18,20 145:20

147:11 148:7,9,18

149:22 150:14

151:21 304:10

305:8 308:9

OMRI's 146:13

147:4,17 148:4

once 21:17 88:5

139:15 173:11

297:19,20 318:3

331:11

onerous 171:4

ones 22:18 41:21

362:21

one's 37:15

one-offs 11:20

one-paragraph

391:5

one-size-fits-all

172:12

ongoing 392:13,14

OP 151:15

open 143:7 241:19

353:5,15,20 394:5

opened 122:22

opening 6:21 14:18

36:9 52:19 56:18

59:9 73:21 78:18

openness 353:19

opens 142:15,15

operandi 336:22

operating 47:21

163:14 192:20

279:6

operation 387:18

operations 167:11

316:11

operator 252:15

opinion 50:20

65:16 69:5 74:21

110:5 113:22

131:7 132:5 230:8

230:8 231:19

232:13 339:16

369:2

opinions 146:9

228:19

opportunities

92:10 344:12

391:7

opportunity 104:22

169:20 182:11

223:7 233:1

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USDA 33:7 103:1

132:3 255:17

351:7 392:2

USDA's 348:4

use 6:15 9:11 10:3

10:4,6 15:14,21

16:10 26:3,6 36:2

37:1 38:16,21

39:12,21 40:17

42:2 48:3 49:19

50:6,9,13 52:7,12

57:10 59:17 61:5

62:9 67:3,15 69:8

69:18,20 71:5

73:15 74:15,15

77:14 84:12 85:11

107:21 112:5

118:2,8 119:1,9

119:12 131:21

143:21 155:17

163:20 165:22

167:9,10,21 170:4

171:16,21 173:12

182:15 184:18

198:14 204:18

206:6 207:3

210:19 218:8

219:5 223:21

224:2 225:21

228:17 229:16

243:7,8,9,18,20

244:2,9,17 246:6

247:8,13,15,19

248:5,8,12,22

263:21 264:17

265:5 266:2

267:12 270:2,4

271:1,15 273:13

273:19 277:21

278:7 284:17

285:2 287:21

288:6 296:9,12,19

297:6,14,15 303:4

313:14,19 339:22

372:2 384:12

useful 7:21 371:20

uses 38:10 56:12

85:10 114:6

185:20 187:4,4

370:2

ushered 392:21

USP 182:14 183:15

usually 136:2 217:9

UV 42:16

U.S 101:16 113:17

117:9 118:2

119:10 195:12

202:10 224:1

225:11,19 354:10

V

vaccines 129:1

vague 87:1 354:13

Valaise 100:3

valid 43:18 88:12

211:6

Vallaeys 105:10,12

105:13 110:3

112:1 113:2,6

114:10

valuable 260:2

280:10 345:17

366:9

value 10:4 15:20

68:7 258:4 280:3

values 46:12,13

198:3 251:5

vantage 365:22

variable 26:16

121:1

variations 170:20

variety 19:2 212:19

225:1 385:20

various 117:15

119:9 120:3,8

144:21 145:7

318:16,16 320:22

321:9 325:17

vary 37:19,22

varying 148:2

vast 210:6

vegans 131:3

vegetables 37:5,21

213:21 214:1

vegetarian 74:10

100:17 233:5

vegetarianism 66:3

vegetarians 131:3

vehicle 393:20

394:7

verbal 344:10

verbiage 355:13

396:2

verify 39:5 164:16

258:4 267:13,16

Vermont 116:10

205:4,4

verse 143:22

version 39:22

239:21 254:15

317:11

versus 26:4 60:6

64:14 69:3 149:9

160:13 207:16

218:5 223:17

236:5

vetted 102:19

VHA 201:19,19

viability 125:15

viable 40:5 120:16

121:2 123:17

183:6 211:11

230:16 338:16

viably 396:6

vibrance 340:1

Vice 126:6 133:8

182:8

view 12:12 268:5

279:16 320:12

351:15 359:3

viewed 307:10

viewing 347:12

379:17

views 109:22

209:15 348:2,3

vigilance 100:21

violate 199:22

violation 102:11

104:9 200:2

virtual 4:11,12

98:8 260:17

vision 214:21

visual 128:9 131:20

176:9 215:20

vital 192:3,14

vitamin 9:7 16:5,11

25:9,14,15,17,21

26:3,6,6,9,12,18

27:2,6,9,11,14,18

27:20,21,22 28:1

28:6,11,13,13,22

29:6 55:19,21,22

74:5 117:2,4,12

118:10,15,17,19

119:7,14 120:4

124:8 153:15,16

157:12,13,16,17

157:20 158:4

204:18 267:5,6,7

267:10,10 270:1,3

270:10,11,15

271:1,3,4,11,17

271:21 272:1

vitamins 25:11,13

27:3 117:18

119:18 153:9

165:7,8,13,19

199:15 259:6

265:20 267:4,18

vitamin-based

117:3,20 118:22

vivo 175:8 176:17

voiced 110:4

volatile 307:19

308:1,10,14

volume 139:17

338:16

voluntary 152:5

243:14 244:21

volunteer 216:19

228:18

vote 10:21 11:9

16:13,14,18 38:15

39:13 40:13,20

41:10 60:18 61:1

75:17 125:13

150:1 210:16

260:20 262:13,13

265:13 270:2

272:15 275:2

276:21 279:22

281:5 282:21

286:21 288:11

297:15 302:17

305:5 310:12,16

312:13 314:5

315:4 332:13,14

342:3 349:8,10

357:21 359:10

360:3 371:13,17

376:2,3 380:6

394:19 395:5

396:17,20,20

397:1,4

voted 11:7 54:19

125:6 188:2

228:12 332:15
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votes 5:7 10:20

54:22 60:19 263:8

269:5 273:8

274:20 277:16

282:20 284:12

286:2 287:16

289:4,7 295:21

307:14 311:11

313:9 315:2

353:17 354:7

376:20 397:21

398:1

voting 9:9,10 39:13

80:3 261:4 267:8

267:11 268:11

272:8 274:3 282:3

283:5,17,18 285:7

295:5 308:20

361:12

vulnerable 181:18

W

wait 32:11 96:11

97:6 281:3 282:20

waiting 337:13

377:16

Wakefield 356:22

walk 111:15

Walker 1:22

109:21 125:5

134:8 222:22

228:11 235:14

262:16 268:12

273:6 274:17

277:12 282:15

284:6 285:17

287:8 288:18

295:11 310:22

312:19 314:9

317:1 318:21

319:2 333:5 376:6

397:6

walking 115:14

want 16:22 21:16

22:4 34:12 35:13

49:17 61:21,22

64:5 67:16 80:9

83:7 91:11,18

97:19,22 98:3,8

99:8 102:16 103:8

103:9 112:22

113:18 114:2,13

114:18 136:20

142:14 145:9

148:6,9 152:1,11

165:11 169:12

179:14 181:20

186:9 191:13

203:4,6,10 205:17

207:1 209:18

210:9 211:13,15

211:22 224:22

228:16 230:18

232:11,15 233:4

235:21 238:12

239:1 248:3

270:13 276:16

278:11 290:6

292:8 297:16

299:5,10 301:20

302:5 309:5,5

326:12 330:8

339:6,8 340:20

342:8 357:6

362:22 366:6

367:5 370:18

371:2,6,15,18

372:1,14 377:18

383:17 384:9,12

385:5 387:16,21

388:22 389:10,15

392:18 394:22

395:2,14

wanted 11:18 21:7

94:10 301:14

308:7 310:5 321:1

321:10 322:12,14

323:9 325:1

328:21 391:17

wants 114:16

287:18 364:6

366:21 392:20

warehouses 199:8

199:9,10

warfare 108:15

warms 143:15

warning 253:20

254:5,7,10,13

Washington

350:11

wasn't 270:17

308:8

waste 180:12

watch 363:5

water 212:5 305:21

306:3

wax 90:5

waxes 164:17

way 13:5,6 51:21

89:2 123:16,22

141:8 142:11,22

143:11 157:7,19

163:15 166:16

171:1 175:22

233:21 240:21

256:10 258:13

264:10 271:7

278:21 279:18

298:17,19,20

299:4 300:15

307:9 308:12

318:17 321:19

329:5 350:8

366:10,18 368:3

382:15 385:15

387:19 389:19

391:20

ways 83:9 106:14

318:16 395:17

WDA 320:9 322:20

weak 70:1 139:16

weakened 142:1

weaning 134:14

weary 139:17

website 6:20 14:18

36:9 56:18 59:8

73:20 78:17

WEDNESDAY 1:7

week 61:5 353:16

weeks 127:15,21

weigh 106:10 321:2

weight 77:2 126:14

welcome 4:13

137:19 188:8

353:18 363:20

well-documented

120:9

well-tolerated

240:17

Wendy 1:19 268:19

286:22

went 90:11 98:17

121:3 237:5

260:14 275:8,8

315:8 318:7

319:16,18 332:6

334:2 354:5

361:20 398:6

weren't 87:14

233:18

we'll 4:21 5:4,6,7

5:12,19 13:12

15:14 35:5 47:16

57:17 58:2,14

73:6 80:4 91:17

139:4 196:4 237:2

247:3 254:18

259:16 260:3

269:11 282:3

283:5 293:20

294:4 305:1 316:3

329:14 345:22

349:6 361:18

395:4 397:4 398:2

we're 4:4 6:6 9:9

9:10 11:21 12:3

12:16 17:15 21:13

22:10 26:15 31:10

38:20 43:9 47:21

50:22 51:4,20

54:16,17 57:22

61:11 69:1 83:6

91:6 92:9 93:14

99:4 112:22 113:8

134:22 146:5

160:21 161:5

162:12,19 163:14

164:16 165:2,21

168:9 169:8

182:16 202:7

203:10 220:20

230:12 233:13

236:13 250:1

252:7 260:19

268:2 279:3 290:9

294:2 299:21,22

300:5 302:6

303:12 304:2

307:22 308:1

310:13 311:12

312:13,15 315:11

316:9,11,14 322:2

332:17 333:1,8,21

341:21,22 348:19

349:6 355:13

356:22 367:15,15

369:14 371:3,3,10

372:1 377:15

380:5 381:9,11,11

383:10 384:10

385:9,21 387:15

389:15,18 393:4,4

393:9,12 394:13

395:1,16 396:4

we've 4:15 12:18

37:13 47:5,11

51:12 60:2 61:7

92:12 123:21

141:1 147:8

156:13 168:7

177:15 179:3

180:4 185:10

215:18 219:18

280:10 312:7

324:16 338:10

348:20 353:16

357:2 361:22

383:8 387:8

what-not 384:7

whey 40:6

wholesome 116:20

wide 19:2

widely 107:12

wife 231:19

William 132:3
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willing 163:3 217:3

262:2 304:22

396:13

Wilson 125:22

135:9,10,12 138:3

138:6,11,20

139:11

window 71:12

281:11

wipe 210:17

wiping 142:17

wise 141:20 293:18

wisely 203:8

wish 102:15 142:5

299:18 309:9

337:19 362:6

371:11

wishing 334:22

374:14

withdraw 293:21

293:22 294:6

371:12 372:15

395:6 396:10

withdrawing 374:3

withdrawn 293:11

375:16

woefully 107:11

women 194:2

wonderful 143:4,4

wondering 29:21

48:5 130:18

148:18 205:20

231:8 233:13

366:18 367:3

wood 90:6

wool 253:3

word 48:3 61:7

142:22 167:3

249:4 290:17

291:2 300:10

323:9 367:8 369:3

369:4,7,13 370:2

373:5,14 377:9

wording 290:6

321:21 364:9

390:4

words 25:20 48:17

245:9 290:14

334:18 340:20

369:16 370:10

372:2 377:12

wordsmith 368:10

wordsmithing

369:7 371:10

work 19:9 49:4

50:11 68:13 72:21

81:21 85:20 90:15

90:16 92:4 93:21

94:3 98:22 99:15

106:1,8 107:18

155:2 162:20

163:22 166:14

174:15 176:12

180:4 195:12

211:10 220:17

223:9 248:21

306:14 329:7,11

329:12,15 334:8

341:9 347:5

358:21 379:10

391:15 395:18

worked 20:6,10

156:15 221:11

338:15 341:11

working 67:8 81:19

98:1 144:20

151:22 163:17

174:16 230:12

316:14 333:7

335:22 337:14

359:7 375:8 384:5

387:10

workplace 225:3

works 204:7

world 33:5,8 37:22

71:10 96:6 193:18

210:22 224:2

226:1 229:4

280:17

world's 170:1

worried 367:12,19

worries 105:6

worry 372:4

worse 179:6 278:16

worth 317:14 338:8

340:10,19

worthy 318:4

wouldn't 111:7

114:13 123:20

138:11 150:14

167:17 178:3

190:9 297:16

298:11 387:11

394:3

wrap 33:22 35:5

64:9 72:16

wrapping 372:18

wreck 165:16

writer 392:20

writing 81:21

144:2 152:9

321:15 335:5

written 7:1 36:11

144:18 195:3,14

223:20 338:2,9

340:12 344:5,10

345:6 346:10

378:16 382:18

394:20

wrong 96:13

113:18 162:8

253:16 291:2

385:15

wrote 338:1

wrought 140:3

Wyard 144:8

151:12,14,17

152:7 157:3

160:17 162:22

167:17 169:7

Wyeth 126:6 133:9

X

x 25:4 34:10 254:12

391:18

xanthan 184:15

xanthan-filled

183:21

Y

Y 34:11 254:12

year 18:3 128:20

175:4 177:19

212:22 259:4

265:19 319:18

years 18:17 20:5

24:16 42:11 46:17

51:12 62:22 63:19

65:2,10 69:12

70:14 95:6,10,11

106:2 116:10

126:7 130:4 136:1

145:19 153:6

154:13 174:17

202:17,17 208:20

212:16 227:21

228:2 266:13

305:9 319:21

341:3 350:9,12

357:3

year-long 391:6,14

year-round 347:10

379:15

yeast 78:7 79:13,16

147:13

yellow 181:14

214:18 322:15

324:9 326:20

yellows 175:5

yeses 269:7 273:8

286:2 289:7,8

yes's 269:6

yogurt 170:1

young 134:17

Z

zap 181:1

Zareb 196:12 208:6

208:8 212:7

Zea 1:21 22:3,9

24:6 29:12 57:2

58:12 61:20,22

64:10 67:6 71:1

72:20,21 78:21

80:14 81:15,18

92:2 94:5 121:8

124:3 130:11

143:1 148:16

153:21 168:11,16

169:1 170:20

178:19 218:14

231:6 233:9

239:13,15 265:6

265:16 267:22

280:6 281:13

283:17 286:7

292:21 294:15

297:9 298:7 304:3

309:10 310:7

380:9 382:1,12

383:14

Zealand 66:17

112:16

zeaxanthin 175:7

Zea's 292:8

zero 321:8

$

$16 359:17

$500 210:13

0

0 40:15 75:18

255:19 263:8

273:8 277:16

284:12 286:2

287:16 295:21

313:9 376:20

1

1 60:20,22 83:10,15

86:16 274:20

315:2 320:18

323:6 365:12

1,000 175:20

1,400 103:13

1:30 222:7,12 236:3

236:13,17 237:1,3

1:43 237:6 238:2

10 64:20 66:12

321:17 328:19

365:12

10th 56:8

10-15 65:10

10:08 98:18

100 3:17 19:7 63:8

142:12 205:4
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104 320:18

104.20(d)(3) 38:7

107-35 313:13

107-35-7 312:1,8

313:18

107.100 46:4,10

11 1:11 269:7

321:17 326:15

328:3 331:14

11th 13:17

12 64:20 66:12

70:14 127:15,21

154:9,10 155:16

164:5,15,16 165:2

166:2,10 225:13

363:6

12:23 237:5

126 163:17

127-40-2 276:5,13

277:20 278:6

12740-2 40:19

13 136:1 311:11

379:11

137-66-6 262:9

264:16 265:4

139 154:7

14 73:11 274:20

315:2

14th 35:21 78:4

15 98:11 99:14

199:12 259:16

263:8 273:8

277:16 284:12

286:2 287:16

295:21 313:9

315:6 376:20

15-minute 361:10

15-1 288:6

16 92:8

17 1:8 82:17

18 20:5 99:14 217:1

180 249:6 252:16

19th 52:4

1933 117:10

1980 197:1,10

198:9 207:17

208:17 223:17

1980's 213:12

1984 131:21

1985 46:5,11

207:17 251:11

1990 101:16

1991 18:15

1996 19:19 20:5

1999 324:8

2

2 84:16 311:11

321:5 323:8 330:1

347:7 379:11

2:10 260:14

2:25 259:20

2:36 260:15

20 25:22 26:1 70:14

174:17 214:15

2000 164:9

2002 331:8

2007 52:11

2008 188:19

2009 185:1

2011 6:11 13:17

14:10 35:21 52:4

56:8 58:20 73:11

78:4

2012 1:8 103:13

2014 166:14

205.605 52:7 78:8

84:12 117:5 147:3

186:1

205.605(a) 80:8

205.605(b) 6:15

13:20 40:17 42:5

56:11 59:1 60:21

61:2 73:14 80:8

264:17 265:5

273:13,19 277:20

278:7 284:18

285:3 287:21

288:6 289:16

291:15 292:21

294:21 296:8,11

296:19 297:6

313:14,19

205.606 14:2 36:1

84:12 147:3

182:19 183:14

186:4

21 38:6 46:10 57:19

197:2

2111 101:16

2118 85:13

2119 85:13,16

22 3:15

238 3:19

239-page 152:2

24 255:19 388:13

25 126:7 130:4

201:18 212:16

321:7

250 25:20 190:8

26 58:20 346:3

378:8

26th 266:9

27 379:5

28 119:17 201:18

29 55:13 116:9

250:12 251:4,13

252:1

29th 6:11

3

3 40:20 323:11,12

3's 104:3

3:41 315:8

3:56 315:9

30 46:16 51:12

63:19 95:10,11

208:20 227:21

228:2 319:17

357:1

316 3:22

38-year 100:17

4

4 3:11 40:20 75:18

269:6 324:18

378:7

4.1 72:2

4.9 72:3

4:49 361:20

40 69:12 357:2

41 123:11

45 123:2,3,8

48 151:20 241:21

242:4 388:13

5

5 29:14 324:19

5:00 361:16,18

5:03 361:21

5:47 398:6

50 210:5 214:14

390:20

500 175:20 181:11

502-65-8 284:16

285:2

541 288:5

541-15-1 286:10,16

287:20

6

6 60:19,22 282:21

289:7,7 325:14

334:15 346:2,22

364:5 365:10

378:7 379:4

397:21

6,500 151:20

60 177:18

600 357:3

605 140:17 147:7

147:12 158:7

605(b) 187:13

210:21

606 147:7,12 158:8

187:13

6510 101:16

7

7 40:15 101:16

186:4 313:14

326:15,16

7,418 41:20

8

8 46:2 327:8 331:19

397:21

8:00 1:10

8:05 4:2

80 102:1

80's 76:19

85 26:10

9

9 68:3 282:21 289:7

289:8 321:16

328:7

9:51 98:17

90 104:1 241:7

249:7 266:9

90th 241:9

90's 193:1

95 156:1 164:10
NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 

1323 RHODE ISLAND AVE., N.W. 

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 

C E R T I F I C A T E

This is to certify that the foregoing transcript 

In the matter of: 

Before: 

Date: 

Place: 

was duly recorded and accurately transcribed under 

my direction; further, that said transcript is a 

true and accurate record of the proceedings. 

 

 ----------------------- Court Reporter 

450

Meeting of the National

Organic Standards Board

USDA

10-17-12

Providence, Rhode Island
202-234-4433

Neal R. Gross & Co., Inc.

Page 1

 UNITED STATES DEPARTMENT OF AGRICULTURE

 AGRICULTURE MARKETING SERVICE (AMS)

 NATIONAL ORGANIC PROGRAM (NOP)

 + + + + +

 MEETING OF THE NATIONAL ORGANIC

 STANDARDS BOARD (NOSB)

 + + + + +

 THURSDAY

 OCTOBER 18, 2012

 + + + + +

 The National Organic Standards

Board convened at 8:00 a.m. at the Biltmore

Hotel, 11 Dorrance Street, Providence, Rhode

Island, Barry Flamm, Chairperson, presiding.

MEMBERS PRESENT

BARRY FLAMM, Chairperson

HAROLD AUSTIN

CARMELA BECK

COLEHOUR BONDERA

JOSEPH DICKSON

TRACY FAVRE

JAY FELDMAN

JOHN FOSTER

WENDY FULWIDER

NICHOLAS MARAVELL

JEAN RICHARDSON

ZEA SONNABEND

MAC STONE

JENNIFER TAYLOR

CALVIN WALKER
202-234-4433

Neal R. Gross & Co., Inc.

Page 2

STAFF PRESENT

MILES McEVOY, Deputy Administrator, National 

 Organic Program

MICHELLE ARSENAULT, Advisory Board 

 Specialist

MELISSA BAILEY, Director, Standards 

 Division, National Organic Program

LISA BRINES, Standards Division, National 

 Organic Program

EMILY BROWN-ROSEN, Agricultural Marketing 

 Specialist

JENNIFER TUCKER, Associate Deputy 

 Administrator 
202-234-4433

Neal R. Gross & Co., Inc.

Page 3

 TABLE OF CONTENTS

Compliance Accreditation &

Certification Subcommittee (CACS)

 Calculating Percentage of . . . . . . . .5

 Organic Ingredients

 Biodiversity Recommendation . . . . . . 19

 Update 

Public Comment

 CACS Work Plan. . . . . . . . . . . . . 28

Crop Committee Proposal . . . . . . . . . . . 53

Handing Subcommittee 

 Nucleotide Proposal . . . . . . . . . .151

Policy Committed Proposal . . . . . . . . . .167

Election of Officers. . . . . . . . . . . . .170

Work Plans

 Certification . . . . . . . . . . . . .183

 GMO Ad-Hoc Subcommittee . . . . . . . .185

 Handling Committee. . . . . . . . . . .188

 Livestock Committee . . . . . . . . . .190

 Materials Committee . . . . . . . . . .193

 Policy Committee. . . . . . . . . . . .194

Adjourn
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1 P-R-O-C-E-E-D-I-N-G-S

2 8:00 a.m.

3 CHAIRPERSON FLAMM: Board Members,

4 please take your seats.

5 Good morning, everyone. We're on

6 the home stretch here. 

7 Our first and last Subcommittee

8 session to present proposals this morning,

9 CACS, and Joe Dickson as Chair, will handle

10 this, and I'll symbolically pass him the

11 gavel, for now. Joe, would you take over,

12 please?

13 MR. DICKSON: Thank you, Barry. 

14 The Compliance Accreditation and Certification

15 Subcommittee has two discussion documents on

16 the agenda for this meeting. One on

17 calculating the percentage of organic

18 ingredients and another on -- a sort of update

19 on the Board's biodiversity recommendation and

20 it's progress, and some feedback from the

21 organic community.

22 I'd like to first ask Dr. Jean
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1 Richardson to present a summary of the

2 calculating percentage of organic ingredients

3 discussion document, and summarize the public

4 comment that the Committee has received to

5 date. Jean?

6 MS. RICHARDSON: Thank you. I'm

7 going to try to be relatively brief on this

8 very complicated topic. So, bear with me, and

9 then of course, there is time for questions

10 later on.

11 So, the problem, as presented to

12 us, basically is that there may be a lack of

13 uniformity amongst the accrediting certifying

14 agencies, the ACAs, in their procedures for

15 verifying the verification of the calculation

16 of percentage of organic in multi-ingredient

17 products.

18 And so, what happened was that the

19 NOP asked us, the NOSB, if we would develop a

20 discussion on this issue and seek public

21 comment, in order to get a clear understanding

22 of what the situation was, and if we could
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1 scroll through that, Michelle, to where the

2 relevant area of the rule is, just so that --

3 not everybody is necessarily familiar with it. 

4 Yes, if we could just scroll that up and then

5 just sort of leave that up there, for your

6 reading, while I talk.

7 So, here is the relevant area of

8 the rule, of how to calculate the percentage

9 organic in multi-ingredient products. 

10 It's relatively straight forward

11 on the surface of it, take out the water, take

12 your liquids, take your dries, add them up and

13 it should be relatively straight forward to

14 do.

15 But the NOP had found, in doing

16 their audits around the country, that there

17 was a lack of consistency from their

18 perspective.

19 So, we sort -- so, we worked on

20 this ourselves, on the NOSB Subcommittee. We

21 sought information from -- well, I'm an

22 inspector, John is in inspection and Zea and
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1 other people on the Board have some

2 experience, obviously, in just doing this

3 themselves, from different perspectives.

4 So, that was helpful, and then we

5 talked to some different major certifying

6 agencies, and got copies of their forms and so

7 on, and then developed a set of questions to

8 send out to the broader community.

9 I should say at this point, that

10 we received an absolutely excellent response

11 from several major certifying agencies. It

12 was in fine detail. 

13 They spent a long time, helping us

14 to understand more clearly, the issue from

15 their perspective, and we also got them from

16 Organic Trade Association, excellent detail

17 that we -- was very useful, from a major

18 processing company and from Organic Valley, as

19 well as from individuals from individual

20 people, and they were just really, really

21 useful.

22 So, basically, what I'll try to do
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1 is summarize, using some of these documents,

2 just summarize sort of the findings.

3 Generally speaking, if you just

4 put it into one paragraph, in most cases, the

5 ACA, the Accredited Certifier's Association,

6 the Association of all of the accrediting

7 agencies, they really feel, from their

8 perspective and all the work that they've

9 done, that there is training that goes on, and

10 not everybody goes to the trainings, however.

11 But by and large, most of the

12 certifying agencies are doing a relatively

13 consistent job, if not, a very consistent job,

14 obviously amongst the large certifiers, but

15 processing, especially for multi-ingredient

16 processing, has grown so fast, that some

17 inconsistencies may have sort have been built

18 in, as the industry has grown.

19 And so, therefore, they

20 appreciated, apparently very much, the fact

21 that we were putting out this discussion

22 document, and came back with some excellent
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1 recommendations to us, as to what to do,

2 including especially, that there should be a

3 large amount of training and information

4 materials placed on the NOP website, that

5 would be easily available to the larger, the

6 smaller ACAs, whoever they are, whenever they

7 feel that they need some information, together

8 with specific examples of what you do in this

9 situation.

10 How do you actually develop a

11 specification sheet? How do you deal with the

12 individual materials that are not properly

13 described on their certificates, and examples

14 of better ways to do this, and then they

15 provide some specific examples, which we will

16 be putting into our recommendation or

17 guidance, as we begin to develop it.

18 So, some of the other -- we posed

19 a series of questions, and I'll just sort of

20 give some of the answers that we got from all

21 of the public comment.

22 Nobody seems to want there to be a
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1 standardized form, and by that, you know,

2 there is like a -- you know, we looked at

3 these in our Committee, this was a simple,

4 self-calculating sort of Excel spreadsheet

5 type form that the larger accrediting agencies

6 use, where you just type in the numbers and

7 magically, the organic percentage appears at

8 the other side, which makes for relatively

9 easy verification, when you're an inspector,

10 and it puts the burden where it should be, on

11 the processor and the handler, in terms of

12 keeping track of that information.

13 The complexities come in, of

14 course, when you have sub-ingredients and sub15 ingredients, and you go back through the

16 system, trying to track all of those

17 percentages, narrowing it down to less than

18 one percent of some minor ingredients, as

19 you're trying to do the calculation, and

20 that's where we need to have some of these

21 specific examples put onto the website.

22 But there was a general feeling
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1 from everybody that we didn't want just one

2 form, that there is enough subtle difference

3 between the way in which the different

4 accrediting agencies do their forms for their

5 calculations, that they should be -- have

6 their own forms, as long as they meet the

7 letter of the law, in terms of the ability to

8 verify the percentage organic.

9 So, in fact, the statement was,

10 "It's not the form itself that's important,

11 it's the method of calculating, is what is

12 really important," and guidance is really

13 needed for that.

14 Same thing with specification

15 sheets, which came up from several of the

16 commenters. If you have sub-ingredients, and

17 you know, you're doing a cookie mix and you've

18 got a bunch of flavors and chocolate chips and

19 all kinds of stuff that are going to go in,

20 each of those need to have specification

21 sheets that would make it much easier, as that

22 product goes through from the processor to the
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1 handler/distributor, through the processing

2 system.

3 On salt, we asked them if the only

4 salt that was used in their calculation --

5 excluded from the calculations was sodium

6 chloride, and the answer to that was, yes,

7 sodium chloride is the only salt that is used

8 to be excluded from the calculations, and that

9 needs to be clearly stated on our guidance

10 document and on the NOP website.

11 Let's see, other things, yes,

12 there is -- very often, when a certificate

13 comes out, like for example, there is a

14 producer that has -- they're producing apples

15 and lettuce and a whole range of vegetable

16 crops, sometimes, those certificates say 100

17 percent on it. Other times, they just say

18 'organic', and they may or may not have an

19 addendum that goes with their certificate. 

20 It may just be a general

21 certificate that says fruits and vegetables

22 organic, and that is not very helpful, if that
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1 product is going to go into a multi-ingredient

2 processing product to be developed, because

3 you don't know whether you're dealing with 100

4 percent, or are you dealing with 95 percent.

5 Are processing aides being used? 

6 Has there been any post-harvest handling that

7 would indicate that the product was less than

8 100 percent?

9 So, we need to have clarification

10 on what would be -- what is needed on the

11 certificates, to make sure that that label,

12 that the consumer sees at the end, clearly

13 reflects what the percentage organic was that

14 went into that, because sometimes, these aides

15 that are used or post-harvest treatments or

16 the manner in which the raw ingredients is

17 handled, sometimes those become ingredients

18 and not just processing aides and not just --

19 like the citric acid that goes into the

20 tomatoes.

21 So, we need to have examples,

22 specific examples of when you need to have --
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1 what you need to have on those certificates,

2 that will allow for clarity.

3 Let's see, other things. Yes, it

4 was pointed out that most of the ACAs do not

5 include processing aides in their

6 calculations. They will be on the back sheet,

7 or they -- and they may be on the calculation

8 sheet itself, just as an aside, but they're

9 not normally -- they're not used in the

10 calculations, but then some of the ACAs do.

11 So, again, we need information

12 about what -- we need to be sure clearly, that

13 we've expressed request to be sure that the

14 processing aides used, are listed clearly, so

15 that the handler, the processor can clearly

16 demonstrate the extent to which there is a lot

17 of that processing aide, a little bit. Does

18 it -- when does it become an ingredient, in

19 order to again, determine if it should be

20 counted in the organic calculations or not.

21 So, like here is one statement

22 from ACA, "Based on the results of our survey,
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1 it appears certifiers could use guidance in

2 determining when a processing aide is

3 considered present in the finished product, at

4 an insignificant level versus present at a

5 significant level, and when a processing aide

6 warrants re-classification as an ingredient,

7 counted in the organic calculations, and

8 listed on the finished product label," and

9 it's those subtle nuances that the small

10 numbers below five-percent and often, below

11 one-percent, that become kind of critical

12 between -- because if you don't do the

13 calculation properly as you obviously know,

14 then your product will drop down from being --

15 from the organic category into the 'made with'

16 category, which is not what a processor

17 necessarily wants.

18 There was general consensus that

19 we didn't need a rule change for the fact that

20 in the present language, the language of the

21 law at Section 205.302A, one, two, three,

22 wherever that is, up there, is that the -- in
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1 regards, the finished product versus the use

2 of all ingredients, it was considered that

3 that would just be a very simple minor change

4 to make, and the accrediting agencies felt

5 that simply a recommendation or guidance from

6 the NOSB would help to clarify that, since it

7 is, indeed, that we calculate the ingredients

8 based on all ingredients, and not just the

9 finished product numbers.

10 The salts, we did that. Yes,

11 there was -- another one is that we need to

12 clarify when we're presenting our guidance,

13 our recommendations, whether water that comes

14 in with the processed ingredient is removed

15 from the calculation of the organic content in

16 a finished product.

17 For example, chicken broth. You

18 don't consider all of the chicken broth, only

19 the solids in the chicken broth, and not the

20 water. 

21 So, at what point -- if you're

22 adding chicken broth to your multi-ingredient
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1 product, you've got to be sure you've taken

2 out the water of the chicken broth that you're

3 adding in, before you make your final

4 calculation.

5 And again, we'll need to have

6 specific examples of these, when we put them

7 on the -- when we put out guidance and when we

8 put them on the website.

9 Let's see, and we could -- and

10 would we please -- another question or

11 statement was, "Could we please provide

12 specific examples that would demonstrate the

13 impact of failing to exclude water and salt on

14 the proper labeling category?"

15 All of these are just very doable

16 and very straight forward things, I think,

17 that the NOSB can certainly work on in this

18 coming semester.

19 Okay, so, sort of in sum, that

20 we've got a lot of encouragement from

21 everybody to move forward with a detailed

22 recommendation, as soon as possible, regarding
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1 a need for clear and comprehensive guidance

2 document, and to request that additional

3 webinar style training for ACAs be done by the

4 NOP, on a relatively regular basis, so that as

5 this burgeoning and fast increasing market

6 really, means that there is an increasing

7 level of confidence of the consumer in what

8 that label actually means at the end, that

9 says percentage organic.

10 So, that's, I think basically, all

11 I really need to do on this topic, and take

12 questions from the Board.

13 MR. DICKSON: Thank you, Jean. 

14 Are there questions or discussion from the

15 Board? 

16 MR. STONE: I'll just add that we

17 intend to engage the certifier's ACA on some

18 of these judgement calls, if you will, that

19 the folks that are using and that help all the

20 time, working with handlers, so, the people

21 that are close to the decision making can

22 advise us in the best way.
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1 The people that are close to the

2 decision, help make that decision and engage

3 them very closely, so, we don't kind of sit in

4 a -- we're not going behind the curtain to

5 finalize this recommendation, I guess is what

6 I'm saying.

7 MR. DICKSON: Any other questions

8 from the Board?

9 As far as next steps on that

10 discussion document, our work plan is

11 currently to take the feedback that we

12 received and fashion a recommendation on this

13 topic for the Spring 2013 meeting.

14 Next, we have Barry Flamm

15 presenting the discussion document on

16 biodiversity.

17 Barry?

18 CHAIRPERSON FLAMM: Thank you,

19 Joe. This discussion document is about

20 implementing biodiversity conservation in our

21 organic agricultural systems.

22 The purpose of the document was to
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1 review progress in implementing the Board's

2 recommendations on biodiversity conservation,

3 which was made back on May 6, 2009, and

4 approved by the Board, by all, but also, to

5 identify other aspects of implementing

6 biodiversity conservation standards that may

7 require further attention, and by seeking the

8 input of the organic community, and another

9 purpose was to further call attention to the

10 importance of biodiversity in organic

11 production systems.

12 As a way of a little background,

13 which isn't really needed with this group, I

14 think, because I think the value of healthy

15 agriculture and for society at large, depends

16 on protecting biodiversity, and this is

17 reflected in a number of places in the -- in

18 our organic regulations, and in response to

19 this, the NOSB issued guideline statements in

20 2004, 2005 and again, in 2009.

21 And during all this period, there

22 has been tremendous, outstanding work done by
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1 the organic community. Much of that is --

2 really, great work has been done by the Wild

3 Farm Alliance, the International Organic

4 Inspector's Association has done a lot of work

5 on training inspectors, and we got help from

6 ATTRA, providing producing guidelines and so

7 forth.

8 My first meeting in May 2008, five

9 years ago, Lynn Coody, representing her --

10 both herself, and the Wild Farm Alliance,

11 called to attention to the Board, the -- a

12 need for some follow up action by the Board,

13 and this ended up with the Board -- the Board

14 agreed with these comments, and established a

15 joint CACC then, and Crops Committee, to look

16 into the problem and issue a statement.

17 There was a draft document

18 produced, that received lots of comments, lots

19 of ideas, and that led to the recommendations

20 and guidance that was produced in the

21 following year, in May 2009.

22 That document sort of divided the
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1 issue up into two parts. One dealt -- one

2 part -- the first part dealt with what the

3 Board itself could do, and that dealt with a

4 material review and looking at our checklist

5 and so forth, and see how biodiversity could

6 be better addressed.

7 The other dealt with the organic

8 system plan, which is so key to the whole --

9 our whole system. That's what gives us both

10 a way of implementing organic standards and

11 guidelines, but it allows for the flexibility

12 to fit the situations, and certainly,

13 biodiversity is a case where every --

14 practically every farm is a little bit

15 different. So, you're going to have different

16 solutions.

17 The recommendations there, again,

18 under the plan, the recommendations were

19 divided up for the certified producer, what

20 they could do, what the inspectors could do,

21 what certifiers could do, and what the NOP

22 could do.
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1 And in this review, we looked at

2 each segment of this, and asked them some

3 questions that -- of each, not only, we wanted

4 to find out what the progress was, but also,

5 whether there was other things we could do,

6 and then -- and in this process, there were a

7 few questions asked that we were trying to get

8 some response to.

9 Just those -- under the material

10 review, a question that was asked was,

11 originally in the first -- and the Board had

12 added questions about biodiversity

13 conservation, the impact, but this was sort of

14 a negative statement.

15 The question was, what are the

16 positive impacts a particular material might

17 have on biodiversity, and that was a question.

18 One of the issues that was raised

19 as an issue, but without any proposed

20 solutions, really in the 2009, was a high

21 value lands, you know, natural lands, high

22 value conservation lands, that might be
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1 converted to organic production, and you know,

2 those lands might -- they can be tempting, for

3 one thing, because you don't have to wait for

4 the transitioning, if they're natural.

5 So, there was some issues there,

6 and we -- the Wild Farm Alliance, besides some

7 39 other groups working with them, had made

8 some recommendations, and we raised the

9 question about their recommendation, what the

10 whole organic community thought of that.

11 Then there is -- I think the other

12 question was about handling operations, and we

13 had heard that some certifiers didn't think

14 that asking -- that handling operations had

15 any impact or needed to pay any attention to

16 biodiversity. So, we asked questions about

17 that.

18 We really got some really good

19 written comments back from -- we got excellent

20 comments back from all these people, the ACA,

21 Beyond Pesticides, Center for Food Safety,

22 Cornucopia, NOC, OCA, Oregon Tilth, Wild Farm
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1 Alliance and several individuals, and yes, I

2 found this one a little late, but QAI had

3 comments also, and I hope I didn't miss

4 anybody else.

5 The way it's organized between

6 general and specific topics, it takes a little

7 bit of searching.

8 But these are excellent comments,

9 and I think we'll give these, all of them,

10 further review in the Committee, and then we

11 got some very excellent comments during the

12 meeting, the session, and I'm personally

13 looking forward to Lynn Coody's comments

14 today.

15 So, I think it's sort of

16 appropriate, five years, 10 meetings later,

17 that she starts it off and has, not the final

18 word, but today, because there is no final

19 word on biodiversity. It will be something

20 we're always going to be -- if we're diligent,

21 we'll always be working on it.

22 I think, as I said, this -- the
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1 comments are, you know, really very useful. 

2 I think the -- everybody, all the comments

3 acknowledges and recognizes the value of

4 biodiversity. I think everyone thought the

5 approach that was taken into those recommended

6 in 2009 were the right approach.

7 I think everybody agreed that, you

8 know, we ought to address the positive impacts

9 of a material on the -- when we review it, on

10 material checklist. 

11 I believe the only comment we had

12 that questioned doing that was Oregon Tilth. 

13 I think there was agreement on conversion of

14 high value conservation lands, as really, an

15 important issue. 

16 There wasn't universal support,

17 but there was strong support for the approach

18 that Wild Farm Alliance made, and those

19 recommendations actually were in a package of

20 other recommendations to the National Organic

21 Program.

22 Not surprising, there was
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1 universally strong support for the need for

2 further education and training, and I think

3 there was agreement that handling operations

4 can affect biodiversity, and that is something

5 that cannot be ignored, and finally, I think

6 several commenters pointed out the importance

7 and need for further National Organic Program

8 guidance, in order to achieve better

9 implementation.

10 There has been excellent progress

11 in that area, and much of the recommendations

12 were -- that had been made in 2009, either

13 have been accomplished or are being

14 implemented or on the work plan to be done,

15 soon.

16 So, I think Joe, that is the

17 summary, and I hope we, you know -- I think we

18 need, as a Committee, to study these comments

19 and look at what we got out of that and figure

20 out in the Committee, you know, what further

21 action or how we should proceed. So, that

22 concludes my comments.
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1 MR. FOSTER: Thank you so much,

2 Barry, for keeping up the momentum on this

3 important issue.

4 Is there discussion from the

5 program or the Board, on this particular

6 discussion document? Questions? 

7 All right, thank you, Barry. Now,

8 we move on to public comment on the CACS work

9 plan. 

10 We have Lynn Coody up first,

11 followed by Bonnie Wideman, on deck.

12 MS. COODY: Good morning. My name

13 is Lynn Coody and I'm commenting on behalf of

14 the National Organic Coalition, a national

15 alliance of organizations representing

16 farmers, environmentalists and other organic

17 industry members and consumers who are

18 concerned about the integrity of the national

19 organic standards, and today, I'm commenting

20 on the biodiversity discussion document.

21 NOC concurs with the CAC that both

22 the NOP rule and the principles of organic
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1 farming recognize the value of fostering

2 biodiversity in organic production systems.

3 NOC has consistently supported the

4 NOSB's recommendations that have encouraged

5 NOP to implement the existing standards on

6 biodiversity and nature resources

7 conservation. We're pleased that the CAC has

8 developed a discussion document to assess the

9 progress on this topic.

10 On the topic of the NOP

11 instruction on biodiversity. 

12 CAC reports on NOSB's earlier

13 discussion for the need of additional guidance

14 on biodiversity and nature resource

15 conservation, because both operators and

16 certifiers and have expressed that more

17 information would be helpful to them, in

18 implementing NOP standards on these topics.

19 NOC thinks that some further

20 explanation from NOP about its expectations,

21 with regard to implementation, will serve to

22 both clarify and standardized certifier's
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1 approaches to these topics.

2 NOC favors development of an NOP

3 instruction that would be framed as a

4 requirement for certifiers under Section

5 205.501-A21, which is the provision on other

6 requirements for certifiers. This would make

7 it a mandatory requirement.

8 Applicability to handling

9 operations. NOC notes that the regulation

10 requires that operations of all scopes of

11 certification address biodiversity. So,

12 instruction on the NOP's expectations with

13 regard to assessment of handling operations

14 would be especially helpful.

15 Although handling operations deal

16 mainly with indoor environments, NOC suggests

17 that there are many opportunities for

18 addressing biodiversity in natural resource

19 conservation, such as, here are a few

20 examples.

21 Landscaping methods and materials

22 around processing facilities. Management of
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1 nearby lands, to mitigate the loss of natural

2 environments, such as wetlands or other

3 sensitive environments, when building

4 processing facilities.

5 Pest control systems that are

6 sensitive to non-target species. Wastewater

7 treatment systems that protect both water

8 quality and quantity.

9 Air handling systems that shield

10 natural systems from dust and fumes, and

11 plantings that create shelter and food for

12 beneficial insects, bats and birds.

13 Audit checklist. NOC notes that

14 the NOP previously recommended revision of the

15 checklist used to audit certifiers, so that

16 the checklist include questions about NOP's

17 biodiversity standards in every assessment of

18 certifiers.

19 We are pleased to see that the NOP

20 recently posted revised checklists that do

21 implement this recommendation. 

22 Now, that NOP has taken that
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1 positive step, we endorse a further step,

2 recommended by the NOSB, that is including the

3 topic of biodiversity standards in trainings

4 that NOP provides for the accredited

5 certifiers.

6 Finally, penalty matrices. NOC

7 continues to review new policies of the NOP

8 with an eye to evaluating their sufficiency

9 for supplementing the standards on

10 biodiversity and natural resources. In

11 September 2012, NOP issued an instruction, and

12 NOC reviewed the penalty matrix associated

13 with this instruction for the requirements of

14 implementing biodiversity.

15 We concur with the comments of

16 Wild Farm Alliance, about the importance of

17 specifically mentioning biodiversity and

18 natural resources in the penalty matrix, as

19 NOC thinks that the current mention of soil

20 and water quality is not broad enough to

21 address operators compliance with all elements

22 of Section 205.200.
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1 Thank you. Just perfect. The

2 only other thing I'd like to say is, again,

3 thanks so much to Barry, for spearheading this

4 great effort on biodiversity. It was really

5 great to be there, making my presentation and

6 having Barry as his first meeting, really

7 speak up strongly and help out. So, I

8 appreciate it.

9 MR. DICKSON: Thank you, Lynn. 

10 Any questions for Lynn? Jay?

11 MR. FELDMAN: Thanks, Lynn, for

12 all your work on this. 

13 What should -- what do you think

14 the NOSB should expect, in terms of things

15 moving forward?

16 You know, if you were to lay out a

17 time line for things to happen vis-a-vis

18 training and certification in this area, what

19 should be the expectation of the NOSB, for

20 that time line?

21 MS. COODY: Well, I think that

22 we've come a long way and we have a lot of
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1 pieces that the NOP, itself, has actually

2 worked on.

3 So, I would like to see -- I mean,

4 there is a great training coming up in

5 January, and I think there could at least be

6 an initial review of what is in place now, and

7 what -- how certifiers can implement this.

8 Of course, many certifiers are

9 already implementing this, you know, they have

10 taken steps voluntarily to include

11 biodiversity in their OSP forms and things

12 like this.

13 But as far as the penalty matrix

14 and the expectations about the way that

15 certifiers will be assessed in their

16 accreditation audits, I think that would be

17 really great topic for including in the NOP's

18 training in January.

19 So, I don't think it would be that

20 hard, and they are already obviously, doing

21 these assessments. So, just letting

22 certifiers in on what to expect, would be
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1 great.

2 So, that is one -- that is -- you

3 know, I'd like to do that. I'll be at the

4 training, and I'd love to see that.

5 MR. DICKSON: John, did you have a

6 comment?

7 MR. FOSTER: Yes, a question,

8 actually. Thank you, Lynn. That was very

9 good.

10 My question, not surprisingly, is

11 on the handling.

12 MS. COODY: Yes.

13 MR. FOSTER: Kind of the

14 expectation. So, do you see that eventually

15 ending up in the form of standards, regulation

16 or is that guidance or -- because that -- the

17 options that you laid out there are all very

18 sensible, you know, thoughtful and likely,

19 doable kind of things.

20 MS. COODY: Yes.

21 MR. FOSTER: Where, in that

22 hierarchy, do you see that falling and what --
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1 you know, how do you see that playing out?

2 MS. COODY: Well, I think, John,

3 it could easily be included in this

4 instruction, that I recommend that the NOP use

5 to help certifiers understand exactly what is

6 expected.

7 So, some certifiers have already

8 included, as I said, they already include this

9 in the handling inspections. But others, it's

10 a new area for them.

11 So, I think it would be a good

12 thing, to have a specific area in this

13 instruction, about handling -- the

14 applicability of these standards to handling

15 operations.

16 It would help, not only certifiers

17 know how to implement this, it would give

18 handlers an idea of, you know, what they could

19 actually put in on their -- how they could

20 fill out the portion of the OSP and what is --

21 many handlers are already doing things like

22 this.
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1 So, they can kind of get

2 biodiversity credit for some of these

3 activities that are already occurring.

4 MR. DICKSON: Thank you, Lynn.

5 MS. COODY: Okay, thank you.

6 MR. DICKSON: Next is Bonnie

7 Wideman, and on deck is Marty Mesh. Don't

8 leave the room, Marty.

9 MS. WIDEMAN: Good morning. I'm

10 Bonnie Wideman. I'm the director of Midwest

11 Organic Services Association, or MOSA, and we

12 certified 1,500 operations in 20 states. I'm

13 also the steward of the land at Pine Knob

14 Organic Farm, and I raise sheep, beef and have

15 organic wool and lamb skins.

16 I'm retiring at the end of this

17 year, and I'm going to be able to devote

18 myself to my farming, and because I'm

19 retiring, I'm at a point where I can look back

20 and I look forward, and I want to express my

21 concerns, that are joined with the concerns of

22 other farmers, in that we are being
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1 overwhelmed with paperwork and the need for

2 documentation.

3 And also, at the same time, I

4 think many farmers would agree with what Vashi

5 said, about the floorboards of organic being

6 taken out, but the ceiling not being raised,

7 and I think the biodiversity is a really,

8 really important area.

9 On my own farm, I have it in a

10 conservation easement, no mining, no

11 development, no conventional farming. I'm

12 going to read to you, a comment by an

13 outstanding conservation farmer that we

14 certified organic, and when I read it, I don't

15 want it to come across as anti-biodiversity,

16 but what I want to stress is that we're not

17 following through on this age of enforcement

18 by increasing the length of the organic system

19 plan. 

20 What we need is guidance from the

21 NOP, as to what we are to look for in

22 biodiversity.
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1 I would love it, if we didn't

2 certify corn that was planted on land coming

3 out of CSP. You know, but give us the tools to

4 enforce. Empower the certifiers. You could

5 do the same with animal welfare. We don't

6 need to lengthen the OSP. We need to feel

7 empowered.

8 So, here is a statement, and

9 again, this is from a farmer whose family,

10 generations back, were leaders in conservation

11 farming, in the Coulee Region of South Western

12 Wisconsin.

13 "Well, Bonnie, I am," this was in

14 2006. We had included a few questions on our

15 OSP, suggested by the Wild Farm Alliance. I

16 took them out the next year.

17 "Well, Bonnie, I am about done

18 with my MOSA application, and I have to

19 confess, I hate it more every year."

20 "Nowhere in bureaucratic heaven or

21 hell are there more extensive or more complete

22 collections of inane, pointless, redundant,
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1 stupid and just plain impossible questions. 

2 Like, have you assessed the farm for

3 biodiversity problems and greatest

4 opportunities, then developed goals and a time

5 line for biodiversity conversation, then

6 please describe or explain."

7 "To make the point of how stupid

8 your question is, you give me one quarter-inch

9 of unlined paper for an answer that the EAP

10 would spend $3.6 million in four years,

11 answering."

12 "The final insult is when you are

13 done with this monstrosity, the organic

14 application, the instructions say, take your

15 47 pages, pull out the staples and make two16 sided copies of everything. MOSA needs to

17 review this process. I have spent two days on

18 it, and I am sure, I am going to be told it is

19 incomplete. Compliantly yours, Vince."

20 So, I made it before the buzzer. 

21 So, thank you, all. Any questions?

22 MR. DICKSON: Thank you, Bonnie.
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1 MR. MARAVELL: Thank you for your

2 comments. I know that many farmers share the

3 sentiment of the quote that you just gave, and

4 they are sincerely trying to meet the goals of

5 biodiversity.

6 So, to the extent that we can come

7 up with the type of flexibility that a farmer

8 is willing to respect, in dealing with a

9 certifier, would be great, because I must --

10 I guess I should -- for full disclosure, it

11 takes me more than two days, to fill out my

12 OSP, and it's getting longer, each year.

13 So, I applaud you on your courage

14 and for the goals that you stand for, and

15 please, help us come to -- give me the time to

16 go out and do the work of biodiversity, get me

17 out of the office.

18 MS. WIDEMAN: Thank you.

19 MR. FOSTER: Bonnie, one more. 

20 Bonnie, one more question.

21 MS. RICHARDSON: Bonnie, I want to

22 thank you very much for your comments, and
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1 they're really right on point.

2 You know, I've been doing organic

3 inspections for the last -- and this is to the

4 Board, too, for the last 13 years, and when we

5 started doing the inspections 13 years ago, we

6 had like three sheets was the OSP, and our

7 inspection report was maybe two sheets. 

8 I mean, it was really, pretty

9 much, check off, and there was a lot of

10 exchange, and just -- I mean, there was

11 probably more discussion than Miles would have

12 liked us to have had, but you know, we -- it

13 worked pretty effectively and it was very sort

14 of educational and empowering to the farmers.

15 But then now, when I go there,

16 their OSP's are usually, I don't know, 25

17 pages long and plus, all the necessary

18 attachments they have to put in, and then my

19 inspection report is usually, I don't know, 25

20 pages long for a vegetable farm. I mean, it

21 is excessive, to put it mildly.

22 And I really agree with you, and I
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1 think it's an important thing for us to be

2 looking at on the NOSB Board, as we begin to

3 work to exchange information with the ACAs, to

4 say, you know, all those folks sitting in the

5 accreditation offices, you know, the kind of

6 people that are there, and I mean, I know lots

7 of these nice people, but they're very focused

8 on forms, and they don't necessarily go out on

9 the field and do a lot of the actual

10 inspections, perhaps as much as they ought to.

11 So, to try to reduce the amount of

12 paperwork, and that just doesn't mean turning

13 everything into computer systems, I'm not sure

14 that that is the answer, either, because I

15 think we have to remember, as you're pointing

16 out in your presentation, that these farmers

17 are human beings trying to make a living, and

18 we do have to be empowering and helpful in

19 every -- in many different aspects.

20 So, I think greater exchange

21 between what the accrediting agencies feel

22 that they need, what NOP thinks that they need
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1 to do their audits right, remembering that

2 we're dealing with either processors and

3 producers or farmers who are trying to make a

4 living by working with a system, which has

5 become increasingly complex, especially as we

6 begin to add in things related to gap

7 certification, as well, and all the other

8 things that are coming in.

9 So, I really appreciated your

10 comments, and I hope you stay, even though

11 you're going to retire, I hope you'll continue

12 to give us some specific examples and

13 feedback, as we try to come up with some

14 useful guidance that doesn't swamp the

15 processors and producers, anymore.

16 MS. WIDEMAN: Right, I think it

17 needs to be -- farmers have commented that

18 inspectors don't inspect anymore, they just

19 review the paperwork.

20 But biodiversity should be

21 inspected and enforced, and it needs to be

22 done on the farm, not on the paper. Thank
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1 you.

2 MR. DICKSON: Wait, don't go

3 anywhere, yet.

4 Zea?

5 MS. SONNABEND: Thank you for the

6 comments, Bonnie, and in general, we at CCOF

7 completely agree with you, and really hope the

8 NOSB, in the future work plans, will get

9 around to working on some issues regarding how

10 much paper is appropriate.

11 However, in my long experience as

12 a farm inspector also, I know that just as

13 biodiversity encompasses a great deal of

14 different types of systems, there are a great

15 deal of different types of farmers, and those

16 questions which are irrelevant to, you know,

17 many, many farmers, will be really significant

18 for some farmer with some type of farming

19 system, somewhere.

20 And so, at some point or another,

21 you know, all of those 25 pages come into

22 play, although not all on the same farm, and
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1 that is what we have to struggle with, to make

2 sure we can encompass all the situations we

3 find out there in the farming world.

4 So, we hope you will continue to

5 participate and help with that, as we struggle

6 with that.

7 MS. WIDEMAN: I certainly will.

8 MR. FOSTER: Hey, Bonnie. I think

9 we have one more question, sorry.

10 MS. WIDEMAN: It's getting

11 embarrassing.

12 MR. DICKSON: Barry?

13 CHAIRPERSON FLAMM: I don't want

14 to wear you out, but I just want to -- as sort

15 of lead person on this, thank you for those

16 comments, because we did get those kind of

17 comments back on -- in 2008 and 2009, from

18 farmers, and we're -- 

19 But I think what you said is a

20 good reminder to keep it down to earth and

21 what we all want is the -- is to be able to

22 help the farmer do a better job in
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1 biodiversity conservation, because that will

2 help him, in the long run on his farm.

3 And I thank you very much for

4 reading that and reminding us of the realities

5 and impacts, and we don't want more paperwork. 

6 We want better practices, and to help the

7 farmer do it. So, thank you very much.

8 MS. WIDEMAN: You're welcome.

9 MR. DICKSON: All right, I think

10 you can go now. Thanks, Bonnie, and Marty

11 Mesh, with the last word.

12 MR. MESH: I'm Marty Mesh, the

13 executive -- you don't have to be sorry, they

14 all appreciated it, actually.

15 I run a non-profit called Florida

16 Organic Grower's, just a credit, Florida

17 Organic Grower's, our certification program,

18 quality certification services. I think, I

19 didn't prepare written comments, because I

20 didn't even know how long you get with these

21 things, whether it's three or four minutes,

22 and I was too busy.
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1 But I think the overarching

2 thought that I had is to thank the Board,

3 obviously, for all the work. It's a

4 tremendous amount, on behalf of everybody. I

5 think, Barry, the other night -- and the

6 biodiversity stuff, we certainly were

7 supportive of, although our certification

8 program, Bonnie articulated it all well, and

9 I didn't know what she was going to say,

10 beforehand.

11 You know, I was scared when Barry

12 no longer has a valid certificate, but wanted

13 to keep his old certificate, you know, during

14 the reception the other day, I that I heard,

15 I came up to him and asked, "I hope that you

16 didn't give up your certification because of

17 the expectation of increased paperwork related

18 to complying with the biodiversity standard,"

19 and so, Bonnie's comments, I just want to echo

20 and reiterate.

21 I've expressed concern that, you

22 know, our certification program again, while
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1 it's supported, biodiversity had a real fear

2 of increasing the amount of paperwork in time,

3 and sometimes, it feels to me like, you know,

4 we're our own worst enemy, as far as the goal

5 of growing organic agriculture, and I see it

6 sometimes in materials review, changing the

7 landscape, changing the rules, you know, you

8 encourage.

9 You know, when I buy a product

10 personally, I really look at, you know, what

11 effect does it have on the farm workers,

12 farmers, the environment, and I want to

13 support that product, and that is why, you

14 know, I choose to buy organic products a lot,

15 and so, to have something that is, you know,

16 99.9 percent organic product, I look upstream,

17 and I don't really care that it has some

18 little thing in it, and I wonder sometimes, on

19 the process of it.

20 I also, you know, I am scared

21 somewhat, I heard the talk about inerts

22 ingredients reviews, which I know are
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1 important, you know.

2 But you know, the amount of work

3 and materials reviews that I think the staff -

4 - I don't know if you guys even talk about to

5 the National Organic Program staff, or your

6 own materials review committee, about what the

7 inerts review will entail. It seems just a

8 tremendous amount, and so, the whole thing

9 seems to be getting not only paperwork-y, but

10 you know, top heavy in the sense of the

11 program.

12 And you know, when I think back

13 years ago, that was what my farming partner

14 said is, you know, when he didn't support the

15 National Organic Program and I did, he asked

16 me, "You know, tell me one thing that the U.S.

17 Government has done, that has been good for

18 organic farmers like us," and it was deathly

19 quiet in the watermelon field that day,

20 because I couldn't think of it, and I said,

21 "I'll make this one different."

22 But you know, I see farmers
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1 fleeing now, from organic because of not so

2 much that they're running away from farming

3 organically or the commitment to environmental

4 stewardship, but from the paperwork and the

5 bureaucracy and stuff like that.

6 But I wanted really, to make sure

7 that I was the last public commenter that

8 Barry ever heard, sitting on the Board, so, I

9 signed up for the last slot, and I just wanted

10 to say thanks, and we have a little parting

11 gift for you, a little DVD from a film that

12 has biodiversity methods in it.

13 MR. DICKSON: Thank you, Marty. 

14 That concludes the compliance -- that

15 concludes our part of the meeting. Barry, I

16 return the imaginary gavel to you.

17 CHAIRPERSON FLAMM: I've been

18 asked to make an announcement, that the Board

19 should sign the 10-year anniversary poster. 

20 It's in the back there, and so it can be put

21 up. 

22 So, everyone, when we have our
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1 upcoming break, please, if you haven't signed

2 it, sign the board back there, and Michelle

3 can put it where you're going to put it.

4 Anyway, I think we're scheduled

5 for a break, now. We may be a little ahead of

6 schedule, but we'll take our break, and then

7 we'll come back to address the proposals that

8 were deferred. We have four proposals from, I

9 guess, three committees that will be further

10 discussed and voted on, this morning. 

11 So, let's take a 15-minute break

12 and be back here at, let's see, 10 after the

13 hour.

14 (Whereupon, the above-entitled

15 matter went off the record at 8:57 a.m. and

16 resumed at 9:17 a.m.)

17 CHAIRPERSON FLAMM: Board Members,

18 please take your seat.

19 Our business now is to address the

20 deferred proposals, from the last several

21 days. 

22 We have four deferred proposals
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1 for the final vote, and beginning with the

2 Crop Committee. 

3 Crop Committee, do you have a

4 motion on any of your deferred proposals?

5 MR. FELDMAN: Yes, Barry, thank

6 you very much.

7 CHAIRPERSON FLAMM: Do you --

8 MR. FELDMAN: I have the motion on

9 rotenone here.

10 CHAIRPERSON FLAMM: Okay.

11 MR. FELDMAN: Okay, sorry for the

12 delay. Appreciate your indulgence.

13 The classification motion, first. 

14 I move that rotenone is a natural substance. 

15 Can I get a second on that?

16 MS. SONNABEND: I'll second.

17 CHAIRPERSON FLAMM: It's been

18 moved and seconded to classify rotenone as a

19 natural substance. Discussion? Any

20 discussion by the Board?

21 To clarify the motion, if you'll

22 agree, Jay, it's to add rotenone to the
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1 National List 205.602 as a prohibited natural

2 substance. No, that is the next part, sorry,

3 I'm ahead of the game.

4 MR. FELDMAN: You're ahead.

5 CHAIRPERSON FLAMM: Excuse me.

6 MR. FELDMAN: Yes, that's where

7 we're headed.

8 CHAIRPERSON FLAMM: Okay, sorry. 

9 Any discussion?

10 Hearing no discussion, I think we

11 can proceed with a vote, beginning with

12 Colehour.

13 MR. BONDERA: Yes.

14 MS. TAYLOR: Yes.

15 MR. MARAVELL: Yes.

16 MR. FELDMAN: Yes.

17 MS. SONNABEND: Yes.

18 MR. STONE: Yes, sir.

19 MS. FULWIDER: Yes.

20 MR. AUSTIN: Yes.

21 MS. FAVRE: Yes.

22 MS. BECK: Yes.
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1 MR. FOSTER: Yes.

2 MR. DICKSON: Yes.

3 MS. RICHARDSON: Yes.

4 MR. WALKER: Yes.

5 CHAIRPERSON FLAMM: And the Chair

6 votes yes. So, we have 15 'yes', zero 'no',

7 and the motion to classify rotenone as a

8 natural substance passes.

9 Okay, now, for the listing motion.

10 MR. FELDMAN: I move that we --

11 the motion -- the following motion, to add

12 rotenone to the National List 205.602 as a

13 prohibited natural substance, effective

14 January 1, 2016. Second, please?

15 MS. SONNABEND: I'll second.

16 CHAIRPERSON FLAMM: We have a

17 motion, which has been seconded, to add

18 rotenone to the national list 205.602, as a

19 prohibited natural substance, effective date -

20 - effective January 2016.

21 Discussion on the motion? Hearing

22 none --
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1 MS. SONNABEND: I'll discuss.

2 CHAIRPERSON FLAMM: John?

3 MR. FOSTER: I'm surprised I'm the

4 only one, but so far.

5 So, I've kind of gone back and

6 forth on this, and I mentioned some of my

7 concerns, the other day, about the optics of

8 it.

9 But I want to at least, talk a

10 little bit about the process of it, you know,

11 having not been a petitioned move, and how

12 that impacts timelines in people's minds, and

13 that it was something we brought forward, as

14 opposed to a different process that we're more

15 used to, and I really -- I would like to be

16 more comfortable with that process, and where

17 we all feel -- how we're feeling about that.

18 Because I haven't been involved in

19 a lot of those conversations, so, I wouldn't

20 mind hearing how people are feeling about the

21 process of it.

22 CHAIRPERSON FLAMM: Jay or Zea,
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1 would you like to address that?

2 MR. FELDMAN: Okay, just to

3 clarify, John, I'm sorry, I was a little

4 distracted.

5 You want to hear about a

6 discussion on the process?

7 MR. FOSTER: Just that this came

8 about --

9 MR. FELDMAN: Okay.

10 MR. FOSTER: -- you know, as a

11 result of an atypical process.

12 MR. FELDMAN: Yes, yes, yes.

13 MR. FOSTER: And you know --

14 MR. FELDMAN: Yes, exactly.

15 MR. FOSTER: And I would like to

16 have more thoughts on that.

17 MR. FELDMAN: Okay.

18 MR. FOSTER: Because I'm a little

19 sketchy about that.

20 MR. FELDMAN: Well, I think this

21 is -- good point. 

22 This has been a learning
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1 experience. This was a Board initiated

2 action, essentially. A Committee member

3 brought this issue to the Crops Committee.

4 Based on, almost a housekeeping

5 issue, that rotenone had been voluntarily

6 cancelled for use in the U.S., by the

7 registrant, by the manufacturer, and it was

8 being phased out and it was determined that

9 even though there is an existing stocks

10 provision of rotenone, that there was -- it

11 was still legal to use in the U.S., and it was

12 confusing that it was not prohibited on our

13 national list, given that there was no longer

14 any use.

15 Now, because it was initiated

16 through the Committee process, there wasn't a

17 full petition, and as you -- as we all know,

18 the petition process essentially, is public

19 notice. It is posted -- the petitions are

20 posted on the NOP website, and gives the

21 public an opportunity to first of all, be

22 aware, and then bring information forward, et
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1 cetera.

2 So, and prepare, really prepare

3 for a potential outcome that might change

4 their practices.

5 So, since we didn't have that

6 process, I think there is a feeling that more

7 time is needed on the back end, as almost a

8 notice to folks, to let them know.

9 But that is why the date certain

10 was added to this provision.

11 Now, you know, there is also the

12 feeling that when you take an action, that

13 requires people to plan, change their

14 practices, their tools or whatever, that

15 giving them a date certain is a very helpful

16 tool.

17 We recognize that dates cannot

18 always be met, and it's hard to predict when

19 something will actually work its way through

20 the regulatory process, but that a three-year

21 time frame sets the right tone and message,

22 that there is concern, as there was within the
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1 EPA regulatory process of the harm associated

2 with the use of this thing, and that the

3 organic standard should not counsel the use of

4 this -- of a material with these sorts of

5 hazards.

6 How that gets implemented around

7 the world, domestically and around the world,

8 is hopefully in a uniform way. We're leveling

9 the playing field for everybody that is

10 growing under the organic standard, to ensure

11 that a material that does not meet the

12 criteria of our statute is being following,

13 and we realize at this point in time, that the

14 remaining users are in developing countries,

15 in banana growing regions of the world.

16 But again, our role here is to

17 establish a uniform standard that we believe

18 is in compliance with the organic law, and we

19 hope that folks in Latin America and around

20 the world can find a -- we trust they will

21 find an alternative to address the thrip

22 problem that they're struggling with in
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1 production, and Zea, I guess has more to say.

2 MS. SONNABEND: My personal

3 agenda, in coming onto the Board, has a lot to

4 do with being very familiar with the history

5 of this Board and the 20 years that it's been

6 around, for which I've been privy to most of,

7 and there are a lot of loose ends that have

8 occurred over that time.

9 Petitions that were tabled, never

10 to be seen again, and things that got resolved

11 in different ways, at different times, and

12 past arguments that really got resolved by the

13 Board saying, "We'll take a look at this in

14 another five years," and then it never

15 happened, and that is what this is.

16 In 1994, there were people at the

17 equivalent of this table, screaming over this,

18 and the review at the time was not really that

19 complete by today's standards.

20 I quoted the entire review, in our

21 document, the one paragraph, that made it into

22 the transcript.
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1 So, it's really worth honoring the

2 sense of the previous Boards, by taking 

3 another look at something like this, and also,

4 the fact that we get questions from consumers

5 and constituents all the time, concerning

6 this, and so, that is why it got brought up.

7 But that being said, I agree with

8 Jay, it's very important that the organic

9 community at large has plenty of notice about

10 pending actions, and that is why we feel like

11 we've chosen a sufficiently long time frame,

12 but have a certain date on it, so, rather than

13 just open-ended for however long the rule

14 making takes, because the certain date enables

15 people to get ready and start doing the work

16 on alternatives.

17 CHAIRPERSON FLAMM: Harold?

18 MR. AUSTIN: While I support the

19 motion as it's been presented, I would like to

20 point out, on behalf of that stakeholder

21 group, that we sprung this upon them pretty

22 unexpectedly.
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1 The regulatory process, for

2 goodness sakes, we know is slow enough in our

3 own country, let alone if we go into a third4 world country.

5 My concern is that the expiration

6 date that we've given will possibly not be

7 sufficient for them, but at the same time, I

8 think it does engage them to the fact that

9 there is a pending drop-dead date out there,

10 and it will then, help them to get involved

11 and start the process moving forward.

12 I would suspect that they will

13 come before us at some point in time, and ask

14 for an extension of time, and I hope when that

15 point in time comes, that does not fall upon

16 deaf ears, and we give it full and due

17 consideration, when they come and they, as a

18 stakeholder, as for our help and

19 consideration, because I think a part of this,

20 the time frame that we've done is also part.

21 Our lack of doing our job as a

22 Board, and not -- and we ignored outside of
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1 our country, stakeholders that are certified

2 by the program, that we are still -- that are

3 also engaged and follow the same rules that we

4 all follow.

5 CHAIRPERSON FLAMM: Nick?

6 MR. MARAVELL: Yes, thank you,

7 Barry. I'd like to draw a little bit of a

8 parallel to tetracycline and streptomycin, in

9 this situation.

10 I think it's appropriate to

11 consider an extension of timeline, but not

12 without certain considerations or conditions.

13 One is that for the date certain,

14 this gives them the ammunition or the sense or

15 urgency in their own countries, and number

16 two, if people come back to us without a

17 report of what they've done, the progress that

18 they've made, the actions that they've taken,

19 and to justify an extension, I would hope that

20 any future Board would not look too kindly

21 upon that.

22 Then again, I harken back to
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1 streptomycin and tetracycline. We can put

2 date certain's in there. We can make our

3 intentions known, but we're flexible, and but

4 when you come back, you better have something

5 to say.

6 And so, I think that should be in

7 the record, that in deed, we're not trying to

8 be unreasonable here, but we expect

9 responsible action on the other side of this

10 recommendation.

11 CHAIRPERSON FLAMM: Further

12 comments? Mac?

13 MR. STONE: I remember hearing in

14 past meetings, that program is -- has asked

15 for specific dates when they're shorter than

16 the normal five-year, and just make sure that

17 everything is in line, or it doesn't hinder

18 the process by some date.

19 CHAIRPERSON FLAMM: Was that a

20 question you were wanting a response to, or

21 just a comment?

22 MR. STONE: If they didn't raise
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1 their hand, then I guess it's okay.

2 CHAIRPERSON FLAMM: Okay, John?

3 MR. FOSTER: So, the time line

4 that you're talking about here, 2016, that

5 we're talking about here, 2016, is -- if part

6 of the intent of that is to allow time for

7 research to be done, to explore the

8 alternatives, and allow for, you know, perhaps

9 another material registration process to

10 unfold, registration process, I can see, but

11 my experience is that three years is not an

12 adequate period of time to generate the kind

13 of data that would convince this body, one way

14 or another.

15 I just don't see how that --

16 unless it's already studies that have been

17 done, to say, now, go, complete something in

18 three years, and bring us back the data, I

19 just -- that feels unreasonable to me.

20 Knowing the standards that this

21 body has, with respect to the data they

22 expect, in order to change a date,
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1 empirically, it's pretty clear, we expect some

2 pretty hardcore data, and certainly, the

3 public demands that.

4 So, I'm not sure how genuine in

5 feel about saying, well, you got three years

6 to generate the data, and you got to meet a

7 pretty high bar, so, I'm uncomfortable saying

8 that with a straight face, because I don't

9 feel like -- I don't feel like that is

10 something they can be successful at, and if

11 I'm off-base on that, let me know, but that's

12 been my observation over the last couple of

13 years, anyway, and if I'm wrong, please tell

14 me.

15 CHAIRPERSON FLAMM: Nick?

16 MR. MARAVELL: No, John, you're

17 not wrong. I share your concern, and that's

18 why I drew the parallel to tetracycline and

19 streptomycin.

20 That is why I think we should have

21 it in the record, that we can be flexible, but

22 we need to see some action on the other side. 
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1 As simple as that.

2 I mean, we're not asking for

3 things that are un-achievable, but they need

4 something on their side, to go back to their

5 country and to their interests, and say, "We

6 got to move."

7 CHAIRPERSON FLAMM: Any further

8 comments? Zea?

9 MS. SONNABEND: I would just ask

10 John if he has a better suggestion of a date?

11 MR. FOSTER: I mean, it's -- at

12 that point, it's kind of splitting hairs, 17,

13 18, 19, I mean, right, I get what Harold --

14 what you were saying, I get about, you know,

15 having a date. I understand the rationale for

16 that. I think that is probably sensible.

17 But four years is -- it's only

18 marginally better than three, and so, I -- I

19 still haven't made up my mind on the vote yet,

20 but I don't want to put things out, that

21 people can't be successful at, knowing that

22 they -- and then if everyone is in agreement,
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1 that they can't be successful at that, then --

2 and providing, you know, the data we need,

3 then I don't know, that seems -- that feels

4 very disingenuous, to me, and if there is --

5 I wish I could come up with a better date. I

6 can't, and still be kind of responsible to the

7 -- obviously, the data that shows that health

8 impacts are a problem, and -- but I am very

9 reluctant about this, but I -- so, anyway, no,

10 I don't have a better date, other than one --

11 you know, one more year.

12 CHAIRPERSON FLAMM: Miles, would

13 you like to comment?

14 MR. McEVOY: Yes, you're -- I

15 think you're mixing up a few things, here.

16 The notification to foreign

17 governments and to the community is done

18 through the Federal Register Notice, when we

19 put out a proposed rule to add rotenone to the

20 prohibited list.

21 So, your recommendation here is

22 not an official notification, and there are a
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1 lot of people that will not note this. Some

2 will, for sure, but there will be a lot of

3 stakeholders that won't note this, until there

4 is Federal Register Notice and the foreign

5 governments are officially notified through

6 the WTO process, where we have to notify them

7 of these types of changes.

8 So, the other thing you have to

9 keep in mind is that this is -- you're adding

10 -- you're making a recommendation to add

11 something to the prohibited natural list, and

12 so, the expiration date is not as critical. 

13 It would give an indication to the

14 program of what your recommendation is for

15 that effective date, but this will be

16 determined by the proposed rule that we would

17 put out and the comments that we would

18 receive.

19 We would try to mirror the intent

20 of the recommendation, but this is not a

21 sunset, where -- or an annotation that you're

22 adding to a recommendation for an expiration
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1 date.

2 So, it's a little bit different

3 than that.

4 CHAIRPERSON FLAMM: Thank you,

5 Miles, for that explanation. Zea?

6 MS. SONNABEND: And I just wanted

7 to reflect to John, about my thinking on this

8 and why I think it's quite substantially

9 different than the antibiotic argument.

10 In that case, there are few, if

11 any, alternatives to be looked into. There is

12 one promising one, but there isn't a range,

13 yet the list that I read of possible

14 alternatives for thrips control, which are

15 well studied in this country, offer many

16 opportunities for them to look into a lot of

17 different things down there, that may not have

18 been looked into, yet.

19 And so, I think that there is --

20 it's not just a long road, as it is on a tree

21 crop, with very few alternatives. There is

22 plentiful research to be done in those three
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1 years.

2 CHAIRPERSON FLAMM: Harold?

3 MR. AUSTIN: Earlier, in our

4 meetings, I made a comment regarding the

5 alternatives that are available.

6 Just because a product is listed

7 as an available alternative material, does not

8 necessarily mean that it has true efficacy and

9 control on that insect species.

10 Thrip, I think will find that a

11 lot of the materials, a lot of the products

12 that are listed will give minimal control, at

13 best. Spinosad will be, by far, the best

14 approach that they'll have, if they can get

15 that certified in the country.

16 But a lot of the alternatives,

17 based off of use here in our country on other

18 crops, are relatively non-effective.

19 So, I think we have to be

20 cautious, when we're looking at any material

21 for review or for addition to the list, that

22 just because there is natural or organic
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1 alternatives available, just because they're

2 classified, and the comments made that they're

3 available, does not necessarily mean that

4 they'd have true efficacy for what they're

5 being called -- they're claimed for.

6 CHAIRPERSON FLAMM: Okay,

7 Jennifer?

8 MS. TAYLOR: Thank you, Barry. I

9 think we also need to remember some of the

10 health concerns and health issues that were

11 brought about, that have to do with not only

12 the environment of the applicator, but

13 probably the environment of other workers,

14 within the distance of the application.

15 CHAIRPERSON FLAMM: Further

16 comments? Further discussion? Harold?

17 MR. AUSTIN: I would agree with

18 Jennifer's comment, that we do need to look at

19 those type of concerns and issues, but I also

20 reflect back onto the information that was

21 provided to us, and I know that it was an

22 isolated snapshot of one company and what they
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1 were doing, but what we saw here, during Luis'

2 presentation and the following presentation,

3 showed an extremely solid process, where

4 adequate -- where it looked like they had

5 adequate PPE in place, protected -- personal

6 protective equipment.

7 The application method looked to

8 be a very specific zone was not an air-blast,

9 cover all of the tree canopy, cover all of the

10 rows, like we do in a lot of our crops here in

11 the country.

12 So, it was very controlled,

13 environmental controlled application, so, I

14 was -- and I can't say that this is the only

15 method being used. I don't know what the

16 label is, in the countries in question.

17 But the process that we saw

18 presented to us made me feel a lot more

19 comfortable than if I would have seen an air20 blast speed sprayer that was putting material

21 on at 400 gallons and going up into the air

22 and covering the entire canopy.
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1 So, I was a little more

2 comfortable with the application and the

3 process that I saw, but that doesn't

4 necessarily mean it's the only application

5 technique that they're using.

6 CHAIRPERSON FLAMM: Further

7 comments? Discussion? 

8 I think we've had a very thorough

9 discussion on this material, and I believe

10 we're probably ready for the vote, and I think

11 the begins with -- am I correct? Anybody else

12 have anything else to say? I don't want to

13 shut anybody off.

14 Okay, we can --

15 MR. BONDERA: Can you repeat the

16 motion, please?

17 CHAIRPERSON FLAMM: I'm sorry?

18 MR. BONDERA: Can the people that

19 made the motion, repeat it, please?

20 CHAIRPERSON FLAMM: Okay, I can

21 read. The motion is to add rotenone to the

22 National List 205.602, as a prohibited natural
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1 substance, effective January 2016. Do I have

2 the correct date?

3 Okay, is that all clear? That is

4 what we'll be voting on, beginning with

5 Jennifer.

6 MS. TAYLOR: Yes.

7 MR. MARAVELL: Yes.

8 MR. FELDMAN: Yes.

9 MS. SONNABEND: Yes.

10 MR. STONE: Yes, sir.

11 MS. FULWIDER: Yes.

12 MR. AUSTIN: Yes.

13 MS. FAVRE: Yes.

14 MS. BECK: Yes.

15 MR. FOSTER: Yes.

16 MR. DICKSON: Yes.

17 MS. RICHARDSON: Yes.

18 MR. WALKER: Yes.

19 MR. BONDERA: Yes.

20 CHAIRPERSON FLAMM: And the Chair

21 votes yes, 15 'yes', zero 'no'. The motion

22 passes.
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1 The Crops Committee, you have

2 another proposal to present to the Board?

3 MR. FELDMAN: Yes, thank you,

4 Barry. The Crops Committee has a proposal on

5 the petition material biodegradable mulch film

6 made with bio-plastic and -- or made from bio7 plastics, and Carmela is going to lead us

8 through that. I think there is a PowerPoint.

9 MS. SONNABEND: Thank you, Jay. 

10 Well, I was trying to figure out how to

11 prepare for this, last night, and when I

12 started thinking about the overall philosophy

13 behind organic farming, I think it goes much

14 beyond the details of how to review materials

15 and categorize ingredients, to the positive

16 effects that we can have on the land through

17 fuzzy concepts like stewardship or nurturing.

18 We wouldn't all be here if we

19 didn't think that less pesticides and petro20 chemicals weren't a good thing, and farms

21 should achieve ecological balance with their

22 environment.
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1 There are times when a broader

2 concept can take precedence over the minutiae

3 of our daily work, and by using the

4 precautionary principle on a global level, we

5 can forgive the taking of a risk on something

6 new, that all the data is not quite gathered

7 for.

8 Biodegradable, bio-based mulch is

9 one of those opportunities to make a real

10 difference in reducing pollution in the whole

11 world, without sacrificing our principles.

12 It's an interesting concept here,

13 to me, between -- or dichotomy I guess,

14 between long term thinking of trying to reduce

15 the plastic burden on landfills worldwide,

16 with the lack of fully long term information

17 on these products.

18 Okay, our studies of the materials

19 over the last several months has led us to

20 want to pursue a recommendation at this

21 meeting.

22 That being said, we've tried to
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1 write an annotation that is as tight as

2 possible, while still allowing the best of

3 these products to be reviewed and allowed in

4 organic farming.

5 Our recommendation is set up, so

6 the first several criteria -- okay, wait,

7 we're going to skip that for now.

8 The first several criteria refer

9 to those certifiers and MRO's who will figure

10 out which products are allowed. 

11 Our last clause is the only one

12 that refers to what a grower has to do, and

13 correspondingly, what their certifier will

14 have to evaluate.

15 It is anticipated that the NOSB

16 and the NOP together, will work on a guidance

17 document that will come out accompanying the

18 final rule, that will outline what the

19 appropriate actions in our annotation are, for

20 the large variety of environmental conditions

21 in soils, that are governed by this

22 regulation.
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1 So, Carmela is going to read our

2 recommended motion and annotations, and

3 needless to say, I skipped the slide that our

4 first motion will be determined, these

5 products are synthetic, but we'll go into the

6 listing motion.

7 MS. BECK: All right, so, that's a

8 long one.

9 So, to list on 205.601B2 mulches,

10 biodegradable, bio-based mulch films, to be

11 reviewed and meet the following criteria.

12 A) completely biodegradable, as

13 shown by one, meeting the requirements of ASTM

14 standard D6400 or D6868, specifications or

15 other international standards specifications,

16 with essentially identical criteria, that is

17 to say EN13432, EN14995, ISO17088 and two,

18 showing at least 90 percent bio-degration --

19 bio-degradation, absolute or relative to

20 micro-crystalline cellulose in less than two

21 years in soil, tested according to ISO17556 or

22 ASTM5988.
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1 B) must be bio-based with content

2 determined using the ASTM D6866 method, C)

3 must be produced without organisms or

4 feedstock derived from excluded methods, D)

5 must be produced without engineered nano6 materials and E) grower must take appropriate

7 actions to ensure complete degradation.

8 MS. SONNABEND: Thank you. So,

9 here is our analysis of the annotation and

10 some of the accompanying issues.

11 First of all, the title,

12 biodegradable, bio-based mulch film reflects

13 our intention to define bio-based, so that

14 this category would not allow products made

15 from AAC, which come from petroleum,

16 originally.

17 Carmela, you want to read that

18 definition?

19 MS. BECK: All right, bio-based. 

20 The ASTM definition of bio-based material is

21 organic material in which carbon is derived

22 from a renewable resource via biological
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1 processes.

2 Bio-based materials include all

3 plant and animal mass derived from carbon

4 dioxide, recently fixed via photosynthesis,

5 per definition of a renewable resource.

6 Bio-based materials are certified

7 using the ASTM D6866 method, which certifies

8 the biologically derived content of bio9 plastics.

10 MS. SONNABEND: Thank you. We

11 have chosen not to use the word bio-plastic,

12 so, that it makes it easier for the NOP to

13 jump through whatever hurdles they're

14 undoubtedly going to encounter in writing this

15 regulation.

16 The Committee also feels that the

17 process of bio-degradation is equivalent to

18 removal of the substance at the end of each --

19 the growing season, as is stated in the rules.

20 Okay, back to -- now, Clause A, we

21 believe the standards referred to here will

22 cover the range of products in the range of
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1 temperatures in environments.

2 We also acknowledge that the ASTM

3 6400 will involve testing for any residues and

4 eco-toxic effects.

5 We welcome the creation of a

6 certification program to these standards, but

7 we cannot endorse such a program ahead of its

8 creation.

9 Clause B, must be bio-based. We

10 feel that with a good definition of bio-based,

11 we are making sure that this testing protocol

12 means something.

13 C), we have decided to be specific

14 about our excluded method language, and we

15 wish to -- I believe we wish to change just

16 slightly, what this says on the screen, but

17 right now it says, "Must be produced without

18 organisms or feedstock derived from excluded

19 methods," and I think we want to at least say

20 and/or, because we don't want either of them. 

21 We don't want someone to choose between one or

22 the other, but we definitely intend to keep
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1 these out.

2 Our feeling is that in the --

3 let's see, while we have some concerns about

4 consistency between this and the excluded

5 methods in other soil inputs, since this will

6 be a brand new category of materials, we wish

7 to shut the door to GMO's at the outset.

8 The annotation regarding the

9 feedstock is not to be construed as carrying

10 over to other soil applied materials.

11 D), must be produced without

12 engineered nano-materials. In the absence of

13 an overall NOP written statement on this

14 subject, we are putting this clause in, to

15 make sure that we keep these out.

16 If the previous NOSB

17 recommendation on the subject gets formally

18 acknowledged before this rule comes out, then

19 it may be removed, and E), the only clause

20 that applies to growers and the certifiers who

21 monitor them.

22 Growers must take appropriate
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1 actions to ensure complete degradation.

2 As mentioned above, we'll be --

3 previously, we'll be issuing a further

4 guidance, we hope, on what actions growers

5 need to take, what certifiers need to do with

6 those actions. 

7 We do think that there may be

8 situations where the use of this mulch is not

9 appropriate, because soil can -- or other

10 conditions will not allow it to break down,

11 and we hope to have -- use the next year or

12 more, to explore those situations, look at the

13 ongoing research and come up with some

14 guidance.

15 Okay, I want to just flag a few

16 other concerns that have been brought up, and

17 this is referring back to the TR, in some

18 cases.

19 This is from lines 592 to 597 of

20 the TR. 

21 Researchers have argued for more

22 extensive research into the bio-degradation
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1 pathways of the various bio-plastics for a

2 more complete understanding of potential

3 impacts, citation given.

4 Complete degradation of the bio5 plastics depends on blending polymers to

6 maximize degradability, and depends on the

7 composition of soil micro-organisms.

8 Due to the biodiversity of bio9 plastics currently being developed, testing is

10 necessary to determine which polymer mixtures

11 are degraded completely and what effects

12 incomplete degradation will have on the agro13 ecosystem.

14 This, as we know, is true. There

15 could always be more testing and more study

16 done on bio-degradation pathways and the

17 potential impacts.

18 We feel that by removing the

19 petroleum source films from this

20 recommendation, that we'll have less to study

21 about residual components and less testing to

22 be done on fewer chemicals.
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1 From lines 649 to 654 of the TR,

2 comprehensive studies were not found that

3 describe the environmental impacts of the use

4 of bio-plastic mulches. Most researchers

5 concluded that the mulches would degrade to

6 carbon dioxide, water and soluble bio-mass,

7 citation given.

8 Due to the wide variety of

9 potential chemicals released from incomplete

10 degradation of bio-plastics, this is a data

11 gap.

12 Some reports have shown that bio13 plastics containing terephthalic -- well, some

14 stuff, acid, at concentrations over 50 percent

15 do not completely bio-degrade in soil.

16 While of the 14 chemicals named in

17 the TR, six of them are from the AAC source,

18 including this one that I can't pronounce. 

19 Therefore, they would be ruled out from

20 materials.

21 Two of them are the pigments. 

22 Three of them are the polymers, themselves,
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1 and three of them are the plasticizing agents

2 that break down completely.

3 There are slight data gaps here,

4 but we see no red flags by prohibiting the

5 petroleum source product.

6 Okay, conclusion. Very clearly,

7 our work on this subject is not over, by

8 passing this recommendation. We need to keep

9 investigating this until a proposed rule comes

10 out, and if red flags arrive during that time,

11 we can point them out during the proposed

12 rules comment period or before, potentially.

13 We are suggesting putting this on

14 our work plan for grower certifier guidance

15 document and putting the unanswered questions

16 into our research priorities for the coming

17 year, as a high priority topic.

18 We understand that the work plan

19 is not finalized on this subject, until the

20 NOP and the Executive Committee takes a look

21 at it, after the meeting.

22 We hope all of us on both sides of
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1 this table will bring a positive message about

2 true sustainability and stewardship motives

3 behind this recommendation, and help inform

4 your constituents about this positive step for

5 the future of our planning. Thank you.

6 CHAIRPERSON FLAMM: Thank you,

7 Zea. That was an incredible statement. Thank

8 you. Jay, where are we?

9 MR. FELDMAN: Well, I think we are

10 at the discussion phase of this. I think we

11 should treat this as a listing motion, and

12 begin the discussion on it.

13 CHAIRPERSON FLAMM: Yes, we have

14 to have a classification motion.

15 MR. FELDMAN: Yes.

16 MS. SONNABEND: Carmela, do you

17 want to make the motion?

18 MS. BECK: So, I'd like to make a

19 classification motion, that biodegradable,

20 bio-based mulch film is synthetic.

21 MR. FELDMAN: Second.

22 CHAIRPERSON FLAMM: We have a
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1 motion that has been seconded, that

2 biodegradable, bio-based mulch film is

3 synthetic.

4 Further discussion? Colehour?

5 MR. BONDERA: Yes, thank you. I

6 just want to say, and I think that in Zea's

7 presentation, it was already addressed, but to

8 reiterate the -- what I personally and I think

9 is received as a little confusing, in terms of

10 the -- what is being, in this case, classified

11 not-listed, but it applies to both.

12 And while I fully understand the

13 conceptualization, I do not think it would

14 hurt if it were repeated, that biodegradable,

15 bio-based mulch film, as the listing, is

16 leaving out reference directly, to what is

17 being considered, which is -- which is the

18 point of why it says it is synthetic, which is

19 the bio-plastic part.

20 And so, I just would like to

21 ensure that that is, at minimum, recognized,

22 that we have removed the word bio-plastic in
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1 this, and I think as Zea said, you know,

2 changes could happen, through this whole

3 process, but your title is unlikely to get

4 very changed.

5 So, I just wanted to say that. 

6 Thank you.

7 CHAIRPERSON FLAMM: Further

8 discussion or comment or response to

9 Colehour's statement?

10 MR. FELDMAN: Thank you. Yes, I

11 agree with that, Colehour, you know, and we

12 did hear from the industry, the bio-plastics

13 industry, which has that exact word in its

14 name, and recognizes the process that produces

15 this material to be a plastic process. We

16 talk about plasticizers, and so forth and so

17 on.

18 So, this is a problem. You know,

19 we all want to be transparent. That is one of

20 our cornerstones, and but you know, this is

21 where it seems like the majority wants to go,

22 the decisive majority wants to go.
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1 I'd feel more comfortable if we

2 had bio-plastics in the title, but the

3 critical thing is really how we manage this

4 material, at the end of the day.

5 CHAIRPERSON FLAMM: John?

6 MR. FOSTER: This has been such an

7 interesting dialogue on this material, and

8 I've really appreciated the opportunity to

9 kind of come around and to appreciate

10 different nuances of it.

11 I was very taken by the long

12 annotation, as I mentioned, and it was -- I

13 thought the process actually did exactly what

14 it was supposed to do, which was present a

15 platform for exchange of ideas, and everyone

16 comes to the table with an open mind and argue

17 points and business.

18 I always pick one material, at

19 every meeting, that exemplifies for me, the

20 process by the -- that I think this is

21 supposed to be, and this was the one for me,

22 where I felt like it was very smart,
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1 respectful exchange on the material.

2 I definitely came around to

3 different points of view then I started with,

4 and I wanted to point that out, including the

5 kind of the nomenclature, with respect to

6 plastics being out, I thought that dialogue

7 was really very well informed and mature, and

8 I really appreciated that.

9 So, this was exactly what this

10 process -- our process was supposed to be, for

11 me, and I think we came to a very good place

12 that is mindful of all of the considerations,

13 and maybe I would go so far as to say, you

14 know, like Calvin, where everyone is a little

15 pissed off about the outcome. I don't think

16 it's quite there. 

17 But I think everyone came to it

18 with an open mind, and I'm -- I was -- I felt

19 actually, very privileged to be part of the

20 discussion. So, I wanted to throw that out

21 there, because this is the best that -- I

22 think this represents our best work. So,
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1 thank you for that.

2 CHAIRPERSON FLAMM: Additional

3 comments on the classification motion? We're

4 talking about the classification motion, right

5 now.

6 If there is no additional

7 comments, we can proceed with the vote, with

8 Nick leading off.

9 MR. MARAVELL: Yes.

10 MR. FELDMAN: Yes.

11 MS. SONNABEND: Yes.

12 MR. STONE: Yes, sir.

13 MS. FULWIDER: Yes.

14 MR. AUSTIN: yes.

15 MS. FAVRE: Yes.

16 MS. BECK: Yes.

17 MR. FOSTER: Yes.

18 MR. DICKSON: Yes.

19 MS. RICHARDSON: Yes.

20 MR. WALKER: Yes.

21 MR. BONDERA: Yes.

22 MS. TAYLOR: Yes.
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1 CHAIRPERSON FLAMM: And the Chair

2 votes yes, 15 'yes', zero 'no'. The motion to

3 classify the material as synthetic passes.

4 Now, we're ready for the motion to

5 list. Jay, who would you -- Jay?

6 MR. FELDMAN: Yes, sir. 

7 CHAIRPERSON FLAMM: How would you

8 like to proceed on the motion to list, and

9 we'll then open.

10 MR. FELDMAN: I was going to

11 suggest that Zea read or cite, what she has

12 already read, the listing, proposed listing

13 motion.

14 MR. FELDMAN: Carmela, do you want

15 to read it?

16 MS. SONNABEND: Okay, the listing

17 motion. To list -- the motion is to list on

18 205.601B2 mulches, iii, biodegradable, bio19 based mulch films to be reviewed and meet the

20 following criteria.

21 A), completely biodegradable, as

22 shown by 1) meeting the requirements of ASTM
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1 standard 6400 or 6868, specifications or of

2 other international standard specifications,

3 with essentially identical criteria, such as

4 EN13432, EN14995, ISO17088, and 2) show at

5 least 90 percent bio-degradation, absolute or

6 relative to micro-crystalline cellulose and

7 less than two years in soil, tested according

8 to ISO17556 or ASTM5988.

9 B), must be bio-based with content

10 determined using the ASTM6866 method, C), must

11 be produced without organisms and/or feedstock

12 derived from excluded methods, D), must be

13 produced without engineered nano-materials,

14 and E), growers must take appropriate actions

15 to ensure complete degradation, and that is

16 the definition part of the motion.

17 I believe we want to read the

18 definition into the motion, to also add the

19 definition to the rule in the appropriate

20 place, bio-based.

21 The ASTM definition of bio-based

22 material is organic material in which carbon
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1 is derived from a renewable resources via

2 biological processes.

3 Bio-based materials include all

4 plant and animal mass derived from carbon

5 dioxide recently fixed via photosynthesis, per

6 definition of renewable resource.

7 MR. FELDMAN: So, that would be

8 205.2.

9 MS. SONNABEND: Okay, 205.2 for

10 the definition.

11 CHAIRPERSON FLAMM: Do we have a

12 second?

13 MR. AUSTIN: Second.

14 CHAIRPERSON FLAMM: It's been

15 moved and seconded, to -- now, I've got

16 switched here.

17 Could we go back to the first

18 screen? 

19 MS. SONNABEND: Which first

20 screen?

21 CHAIRPERSON FLAMM: The listing

22 motion. So, I won't reread this, unless you
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1 request it.

2 Is the motion, the listing motion

3 clear, and then we'll look at the definition,

4 which will be added. Does anybody object to -

5 - or unclear, I should say, about what we're

6 about to -- we will vote on? No question? 

7 Does the program have a -- Miles? 

8 MR. McEVOY: Yes, we have a

9 comment. If you want these, what you're

10 calling biodegradable, bio-based mulch films

11 to be allowed to be used in organic

12 production, within the -- a shorter time

13 frame, we would suggest that you remove the

14 Clause D, must be produced without engineered

15 nano-materials.

16 We have a recommendation from the

17 Board on nano-materials, that we're working

18 with. We'll be meeting with OMB and other

19 agencies, to look at the implementation of

20 that particular recommendation.

21 But part of the problem with that

22 recommendation is, there is no Federal
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1 definition, consistent definition of nano2 materials.

3 So, in order for us to incorporate

4 that particular clause into this rule making

5 action, would significantly slow down and

6 potentially, even stop the ability to get this

7 substance listed. It's just going to make it

8 very, very difficult and slow down the

9 process.

10 So, if you want that to happen, if

11 it's that important, leave it in, but if you

12 really want these substances to be allowed by

13 organic farmers, then I would suggest taking

14 it out and working on nano-materials through

15 other mechanisms.

16 CHAIRPERSON FLAMM: Sort of a two17 part thing. The first part is that the Board

18 is clear on the motion that is now before us. 

19 If they're clear, I'll -- I'll move the

20 discussion, and Miles has made a comment on

21 the motion, and what he has identified as a

22 problem with the motion.
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1 So, first of all, I want to be

2 sure that everybody understands what the

3 motion is before us. 

4 So, I think everybody is

5 acknowledging, they are clear on the motion,

6 and so, I'll open it to discussion, and

7 perhaps, the first -- I think I'll just ask

8 either Zea or Jay, to respond or open the

9 discussion with a comment on Miles' comment

10 and the concerns that he expressed.

11 MS. SONNABEND: Okay, Nick, did

12 you want to say something?

13 Let me, okay. We wanted to ask

14 Miles if instead of this clause about nano15 materials, if we referred to the NOSB's own

16 recommendation about nano-materials, would

17 that help solve the problem at all, because we

18 have our own recommendation, and if it's

19 internal, maybe that would help.

20 MR. McEVOY: Yes, the problem is

21 putting it into the recommendation, because

22 that is what would have to be in the
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1 regulatory text, that we would have to get

2 through all the various legal and clearance

3 processes, and it's a complicated situation,

4 without -- with a lot of agencies involved, in

5 terms of nano-materials, the definition of

6 nano-materials, how they're overseen and

7 regulated by the Federal Government.

8 So, if you had it in your -- the

9 body of your recommendation, that would be

10 different, but having it in the actual

11 annotation, is where it would cause us

12 significant difficulties in getting this

13 approved and through the clearance process.

14 MR. MARAVELL: Miles, I completely

15 understand, and I'm just wondering if there is

16 a way to indicate that it would be produced

17 without nano-materials, when such definition

18 is promulgated, you know, but it would not be

19 effective until such definition is

20 promulgated.

21 I mean, would that give you enough

22 of an out? I think we need to be able to tell
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1 the community, fairly definitively. So, does

2 that work? 

3 So, that is just a question you

4 may want to think about it, before you get

5 back to us, on that, but we clearly, do not

6 want to hold this up, and if this will hold it

7 up, we can take other action, but if there is

8 a middle ground there, we would be willing to

9 consider that, too.

10 MR. McEVOY: Yes, well, we can

11 consider that, but again, that would slow it

12 down.

13 You've already made it -- you

14 already have a final recommendation on nano15 materials. You've made it -- you've proposed

16 a -- or made a recommendation on a definition

17 for nano-materials. So, we have that.

18 So, the problem is, is if you put 

19 it in the annotation, we're going to have

20 extreme difficulty. There is just -- the

21 difficulty, it's just going to take a lot of

22 time, where there is a lot of different
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1 entities that we'll have to work with, to get

2 that through the process.

3 It's going to take a lot more

4 analysis, a lot more staff time, to do that.

5 Now, nano-materials is not a

6 recommendation that we're ignoring. We are

7 moving forward on that, but it is a final

8 recommendation. There is many NOSB final

9 recommendations that we still have to work on

10 and implement.

11 What we're suggesting is that this

12 is not the place that you -- in order for us

13 to effectively move forward, if you leave it

14 in the annotation, it will make it extremely

15 difficult for us to move forward in any kind

16 of expeditious way.

17 CHAIRPERSON FLAMM: John?

18 MR. FOSTER: So, this is kind of

19 the discussion I was referring to earlier,

20 where this kind of dialogue is just, as some

21 would say, a natural and zesty enterprise.

22 But my -- anything having to do
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1 with holding this up, and this came up in our

2 Subcommittee meeting last night, was my

3 biggest concern, other than what I have

4 already said about making preferable materials

5 easier to use than the less preferable

6 materials, is that every month, every day,

7 every year, this doesn't move forward, is that

8 much more un-biodegradable plastic in the

9 environment, and it ends up everywhere, we

10 know.

11 We all know where it ends up, and

12 I don't -- we're so close to giving -- to

13 putting a dent in that, I think it's really,

14 really important that we design this, so that

15 it moves as quickly as possible.

16 That is a big priority for me, and

17 as I said last night in our evening

18 Subcommittee meeting, but so, if that is a

19 hazard, and it's going to postpone this, it

20 sounds like it is, then I want to avoid that

21 hazard.

22 It's predictable, and as my mom
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1 would say, therefore, it's preventable. So,

2 I think we should prevent that.

3 CHAIRPERSON FLAMM: Further

4 comments? Jay?

5 MR. FELDMAN: Thanks, Barry and

6 Miles, for your comment.

7 I'm trying to understand the

8 process here, and I, you know, I know that as

9 has been mentioned, we, as a Board, adopted in

10 2010, unanimously, as you know, the definition

11 of engineered nano-materials, and we

12 appreciate the program working -- moving that

13 forward.

14 Then in December of that year,

15 2010, you wrote a memo, that really, I hope,

16 could be used in this instance. It ended with

17 -- you know, you explained the uncertainty and

18 the lack of Federal guidance and so forth on

19 this, and then you ended with something that

20 I really appreciated at the time, the NOP

21 accepts the NOSB recommendations and tends to

22 gather additional information about how nano-
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1 materials are regulated and used in the

2 agricultural production process.

3 So, I guess my point here, or

4 question maybe, is if the program accepts the

5 process that the Board went through in

6 defining this thing, and the Board, as you

7 know, worked a long time and heard a lot of

8 public testimony on this issue, is there a way

9 we can incorporate that statement that the

10 Board adopted, as guidance, and then add

11 Nick's language, you know, pending some other

12 action by the Federal Government, or by USDA,

13 so we can expedite this, just so that, you

14 know, we can do this in a way that, as John

15 says, moves this along quickly, but also gives

16 the Board some assurance that there won't be

17 plastics folks jumping all over this thing,

18 with nano, because we know that there are

19 folks out there that would like to do that

20 kind of thing.

21 So, it's just a way of almost

22 setting a moratorium, until the USDA comes up
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1 with a definition, that it feels is

2 appropriate.

3 MR. McEVOY: Yes, well, you

4 already have the recommendation -- final

5 recommendation on nano-materials defined,

6 nano-materials and consider nano-materials to

7 be a synthetic substance. We've accepted

8 that. 

9 So, that is the way that the

10 program and the, we expect certifiers and

11 companies to accept that, as well, that nano12 materials are considered synthetic substances,

13 and therefore, not allowed unless they're

14 added to the national list.

15 So, that is the concept, and that

16 is what some of the power of your final

17 recommendations can do. They set the tone.

18 For us to issue various documents,

19 requires different levels of clearance and

20 approval. So, for us to issue a memo to the

21 Board, that we accept your final

22 recommendation on nano-materials, sends a
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1 statement, but it's not a regulatory text. It

2 hasn't gone through public comment and rule

3 making.

4 So, it doesn't have the same level

5 of authority, as a rule on nano-materials or

6 putting nano-materials and prohibiting nano7 materials into the USDA organic regulations

8 would have.

9 That is going to take a lot more

10 time and a lot more work, because there is a

11 lot of affected parties there, and a lot of

12 people that probably will have comments on

13 that particular thing.

14 So, my suggestion would be that

15 the -- if you want to have this particular

16 substance be available to organic producers,

17 that you remove that clause, and you include

18 that in the background information that you

19 have around this particular recommendation.

20 But if you leave it in, as part of

21 the annotation, that means that we have to do

22 all the rule making around your particular
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1 final recommendation on nano-materials, which

2 is very complex. It's not an easy task for us

3 to do that.

4 We have recommendations from the

5 Board, from 10 years ago, that we still have

6 not implemented. So, and nano-materials is 

7 not an easy one. 

8 We have accepted. We do recognize

9 that the Board considers nano-materials as

10 synthetic and therefore, they're not allowed

11 in organic production or handling.

12 But to raise it into the rule

13 making process will delay that in very

14 substantial ways.

15 CHAIRPERSON FLAMM: Thank you,

16 Miles. Nick?

17 MR. MARAVELL: Yes, Miles, maybe

18 the easiest way to do this is put it in the

19 positive. 

20 Can you explain to the Board, if

21 we drop that clause, let's say we just take

22 'D' out, how the program would proceed and how
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1 that would have an impact on the review of

2 this material, and what would be permitted

3 under your understanding of how you would

4 proceed?

5 In other words, tell us how it

6 would play out. What would be the impact, if

7 we dropped that and put it in the -- and put

8 it in the background material, just say how --

9 how would you then review materials? How

10 would you expect materials to be reviewed? 

11 How would this have an impact?

12 MR. McEVOY: Well, we would expect

13 these materials would be reviewed by material

14 review organizations, and that they would --

15 once this was added to the national list, that

16 they would then review these materials, based

17 on the annotation.

18 Then if there were particular

19 questions about, let's say, the clause and

20 nano-materials is removed, if there were

21 questions that a manufacturer was using nano22 materials, they would go to the final
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1 recommendation from the NOSB on nano-materials

2 to say that those are synthetic substances and

3 are not allowed in those substance -- those

4 products that are being approved.

5 So, they could rely on the

6 background information on this particular

7 recommendation, as well as the final

8 recommendation on nano-materials. That would

9 be their guidance.

10 MR. MARAVELL: And at this point,

11 we have no reason to believe that nano-tech

12 materials are included in the substances that

13 are included in the petition. Is that

14 correct?

15 Right, so, we are not approving

16 nano-technology materials. We are approving

17 what is in the petition? Would that be also,

18 a correct statement?

19 MS. SONNABEND: There were --

20 there are no -- none of the products submitted

21 in the petition are made using nano-materials,

22 at this time, and to our knowledge and asking
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1 the petitioners, none are planned.

2 So, I don't -- you know, this is

3 not something that we have to keep out,

4 because it's in there on a day-to-day basis. 

5 This is a protective clause, and as a

6 protective clause, it is my opinion that we

7 shouldn't bog the whole thing down by keeping

8 this in. We should just put it in the

9 background material, just as we're putting in

10 the clause about, that we interpret the bio11 degradation to be equivalent to the removal

12 step. 

13 I think if we also put a sentence

14 in the cover, saying that we fully expect that

15 these materials will have to meet the NOSB's

16 recommendation on nano-materials.

17 MR. MARAVELL: But weren't we also

18 going to be making a statement that what we

19 have reviewed in the petition, is what we are

20 approving, and that people can't just use the

21 moniker of a bio-based, bio-film mulch, to put

22 any synthetic that they would desire into that
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1 product, is that also correct?

2 Weren't we planning to make that

3 statement? Yes, so, this might work.

4 CHAIRPERSON FLAMM: We have other

5 Board members that would like to ask

6 questions. Jean, please.

7 MS. RICHARDSON: I was looking

8 forward today, to voting on something that is

9 actually going to give something to the

10 organic farming community, because we always

11 seem to be voting 'no' on everything.

12 So, it is important to me, if I

13 want to get back to Vermont and the Northeast

14 alive, that we do vote on this today in a

15 positive way, and so, I would actually

16 encourage a modification of the listing

17 motion, to remove the line 'D', a this time,

18 on the clear understanding, obviously, the

19 issue on engineered nano-materials will be

20 within the body of the general statement that

21 is attached to the listing motion.

22 CHAIRPERSON FLAMM: Tracy?
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1 MS. FAVRE: Thanks, Barry. Jean, I

2 would -- actually, I was just getting ready to

3 make a similar comment.

4 I feel as though that if we don't

5 remove it, we are essentially, creating a

6 backdoor veto to the listing of the product

7 itself, and I think as long as we have

8 sufficient intent expressed in the background

9 materials, that will then be used in

10 combination with the nano-technology materials

11 recommendation, that should be sufficient, and

12 I, personally, would like to see this move

13 forward, as well.

14 CHAIRPERSON FLAMM: Zea?

15 MS. SONNABEND: As the maker of

16 the motion, I would like to accept what Jean

17 and Tracy said as a friendly amendment, and

18 remove Clause D of the annotation, to be put

19 in the background materials, appropriately. 

20 Does the second agree?

21 CHAIRPERSON FLAMM: Okay, just a

22 technical point, there is -- Robert's Rules of
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1 Order doesn't recognize friendly amendments,

2 but if the Board, as a whole --

3 MS. SONNABEND: What is that?

4 CHAIRPERSON FLAMM: I'm just about

5 to tell you. It's a technical point, but let

6 the record show that we follow Robert's Rules

7 of Order.

8 If it's a -- if the Board does not

9 disagree, we can accept this change. So, it's

10 a full Board decision, not an individual

11 decision.

12 Seeing no objection to the change,

13 I believe it's accepted. So, would you

14 briefly restate what the change is, so

15 everybody is clear on what we're voting on?

16 MS. SONNABEND: The motion on the

17 floor then is the entire thing you see on your

18 screen, except for Point D.

19 But be assured that Point D will

20 appear in our narrative that accompanies this.

21 CHAIRPERSON FLAMM: And do we have

22 -- does the -- do we have a second to this
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1 motion?

2 MR. AUSTIN: Second.

3 CHAIRPERSON FLAMM: It's been

4 seconded, that the listing motion, plus the

5 definition, which has not changed, minus what

6 is the number now? Minus 'D', is every -- is

7 the Board clear on what we're -- we will vote

8 on?

9 Jay, do you have a -- further -

10 MR. FELDMAN: Yes, thank you. I

11 realize the sense of urgency to move this, and

12 we'll talk about that a little later, when it

13 comes down to another text change that we've

14 discussed.

15 But on nano, specifically, and

16 this particular amendment, or this motion, I

17 hope we can include in the statement, the

18 background material, the actual policy itself,

19 so that the Board is aware of what, at least

20 has been established by the Board previously,

21 as the responsibility for recognizing the

22 unique properties of nano, that distinguish
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1 them from all other listings of this

2 substance, sort of in the realm of what Nick

3 is saying.

4 That we understand, we're

5 approving, in effect, non-nano forms of this

6 bio -- I can't say bio-plastic, can I? 

7 Biodegradable mulch film, and that they are

8 not allowed, that is the nano-form of this

9 material, should it become available, are not

10 allowed by a listing of the bulk form of the

11 substance, on the national list, and that, in

12 effect, serves as a prohibition of the

13 engineered form, the engineered nano-material

14 form of this listing.

15 So, I hope we can be more -- I am

16 just hopeful and maybe we can get an agreement

17 here, that we will re-list that, so that

18 everyone is clear on -- as to what the policy

19 says, and how it is intended to function.

20 CHAIRPERSON FLAMM: Jay, I want to

21 -- I'm not clear myself, on that. Maybe

22 others aren't. 
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1 We have a motion on the floor. 

2 MR. FELDMAN: Well, the motion

3 included -- well, the motion was to take this

4 out, but as it was described to us, it

5 included the incorporation of the no-nano

6 clause in the recommendation, itself.

7 So, I just to amplify on that --

8 Zea's proposal on that, to suggest that we

9 actually include and cite the policy that was

10 adopted by the Board, previously.

11 CHAIRPERSON FLAMM: So, this is

12 for the background statement, and not changing

13 the motion?

14 MR. FELDMAN: Background, yes.

15 CHAIRPERSON FLAMM: I'm just

16 trying to --

17 MR. FELDMAN: In the background

18 statement.

19 CHAIRPERSON FLAMM: I am just

20 trying to clarify that for the record --

21 MR. FELDMAN: Yes, in the

22 background statement.
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1 CHAIRPERSON FLAMM: -- that that

2 is what you're doing.

3 MR. FELDMAN: Yes, yes.

4 CHAIRPERSON FLAMM: Okay, further

5 discussion? Nick?

6 MR. MARAVELL: Yes, Jay, I just

7 think we need to be a little bit flexible. 

8 I'm not sure we want to prohibit nano. I

9 think we want to just say, "We have not

10 approved any nano in our review of this

11 petition, if the program needs such

12 flexibility, in the way they proceed."

13 So, you know, do you -- well, let

14 me ask the program. Do you care whether we

15 say, "We would prohibit nano-technology," or

16 simply that it is not in this petition, we did

17 not review it, and we are not approving it?

18 CHAIRPERSON FLAMM: Miles, would

19 you respond to that question, please?

20 MR. McEVOY: What we are saying is

21 that if you leave Clause D into the motion,

22 that that would significantly decrease our
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1 likelihood of getting this listed in the near

2 future.

3 CHAIRPERSON FLAMM: Mac?

4 MR. STONE: Shift gears a little

5 bit. So, from the certifier point of view,

6 couple of thoughts.

7 The word 'complete degradation', I

8 have a little concern that if a grower is in

9 a dry climate or an environment where he is

10 having trouble, they try it and it doesn't

11 work the way they hope it does, for various

12 environmental conditions, that they, or the

13 certifier/inspector is not in a position of

14 dinging the farmer, even though they're

15 assuring appropriate actions are be taken, but

16 completeness didn't happen.

17 So, I guess some guidance is

18 necessary around that, which in conversation

19 with the program, that is behind the scenes of

20 this, the guidance behind that.

21 But just to make people aware,

22 that that could be an issue for somebody, and
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1 since it's not a plastic, it doesn't fall into

2 the 'must be removed' thing.

3 So, I think that language helps

4 for that side, but 'complete' is a little bit

5 worrisome, I guess, not to -- I am not

6 amending the motion, I'm just acknowledging

7 that.

8 CHAIRPERSON FLAMM: Further

9 questions and discussions on the motion that

10 is before us?

11 If not, we can proceed with the

12 voting.

13 MR. FELDMAN: Well, yes, I have

14 another issue, I'm sorry.

15 MR. MARAVELL: Point of

16 clarification. Are we just voting on the

17 motion to take 'D' out of the proposal, or are

18 we voting on the entire proposal?

19 CHAIRPERSON FLAMM: We already --

20 MR. MARAVELL: Took 'D' out?

21 CHAIRPERSON FLAMM: -- did that. 

22 We already did that.
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1 MR. MARAVELL: Right, well, then I

2 think there is additional discussion, before

3 we call the vote.

4 CHAIRPERSON FLAMM: Okay, that's

5 what we've been doing, I thought.

6 MR. MARAVELL: Yes, yes, yes.

7 CHAIRPERSON FLAMM: Okay.

8 MR. MARAVELL: I'm just saying, I

9 think there is quite a bit more, yes.

10 CHAIRPERSON FLAMM: Okay, I assume

11 if you -- then you want to make another

12 comment?

13 MR. MARAVELL: I want to give

14 others an opportunity to speak, but I have

15 more points.

16 CHAIRPERSON FLAMM: Okay, I think

17 I tried to give everybody an opportunity, and

18 if you go ahead, Nick, if you've got further

19 discussion.

20 MR. MARAVELL: Yes, well, first of

21 all, I want to associate myself with the --

22 with Mac's comments, as it -- as a farmer,
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1 you're going to read this and it says

2 'complete degradation'. 

3 Well, I know that in regulatory

4 language, 'complete' may mean something else,

5 but a farmer says, "That means 100 percent,"

6 and I hope that in the guidance, it will be

7 clear, that nothing is 100 percent, and we're

8 not going to scare people from using this

9 product, because they're going to say, "Does

10 that mean I've got to cover it up and bury it,

11 so that nobody can possibly ever see it," and

12 actually, that may -- if they cover it up and

13 bury it too deep, reducing moisture, oxygen

14 and temperature to the product, it may

15 actually retard its degradation.

16 So, I would like to know what

17 other think about this, in terms of what

18 message we're sending, and whether or not the

19 program has any views on, if they anticipate

20 putting out guidance on this particular aspect

21 that Mac raised.

22 CHAIRPERSON FLAMM: Any other
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1 questions? Discussion by the Board? Miles, do

2 you want to respond to Nick's question?

3 MR. McEVOY: Okay, so, Nick,

4 you're asking what -- about the grower must

5 take appropriate action to ensure complete

6 degradation, and part of this proposal, I

7 heard was that the Crops Committee would want

8 to work on developing guidance for how that

9 would be implemented, is that correct?

10 MR. MARAVELL: Yes, yes.

11 MR. McEVOY: So, it seems like it

12 could be handled through that process, of

13 working with the Crops Committee, on what the

14 appropriate guidance or instruction to

15 certifiers would be, to meet the intent there,

16 that the growers, which is the active word

17 there, they're the ones that have to take the

18 appropriate actions, yes.

19 CHAIRPERSON FLAMM: Jay, and then

20 Mac.

21 MR. FELDMAN: Okay, thank you. 

22 Okay, so, here, I'd like to follow up on your
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1 comment, Jean, about sort of weighing the need

2 and the need to go forward with this, in an

3 expeditious manner, and our need, as a Board,

4 to make sure that we are evaluating this thing

5 under our criteria.

6 I understand there are always

7 uncertainties and I think we have to bring --

8 you know, address those uncertainties in ways

9 that -- best ways we can.

10 I, for one, am willing to accept

11 some uncertainties, if there are threshold

12 issues that I think we, as a Board, have

13 adequately addressed, and on the science here,

14 I'm willing to accept some of the

15 uncertainties that we've heard about, that Zea

16 actually referenced, in terms of the

17 unanswered questions that are in the technical

18 review.

19 And I think that is something that

20 we all have to come to, maybe in a different

21 way, but understand what those things are.

22 So, I want to put that context
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1 around what I have to say about the last

2 clause in the listing motion.

3 One of the things I've learned,

4 being on the Board for three years now, is

5 that it's very hard to get the horse back in

6 the barn, after the barn door is open. I

7 mean, we all know, we've experienced that

8 probably, literally and figuratively.

9 So, the issue with something like

10 this, where there is a fair amount of

11 uncertainty still, everybody acknowledges

12 that, and there is a need to do more research,

13 there is a need to develop guidance, there is

14 all kinds of needs.

15 My feeling is that we really need

16 to start with the narrow, a narrow -- get this

17 -- get a foot-hold with this material, get it

18 going, but do that in a narrow way, and expand

19 on it.

20 It's easier, much easier to expand

21 on something, in a deliberate way, with better

22 information, than pull something back, once
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1 it's out there. We've experienced this over

2 and over and over again.

3 So, with that being the theme, I -

4 - when we started this discussion, the Crop

5 Subcommittee, we started with the presumption

6 that -- and looking at the data from the

7 manufacturer, that we would be able to assume

8 compliance with the degradation, or the

9 removal, equal in degradation, within the time

10 frame that was envisioned by the law.

11 At that time, since the

12 manufacturer petitioned as a bio-plastic, we

13 evaluated as a -- we evaluated it as a plastic

14 and we looked at OFPA, and OFPA says removal,

15 at the end of the growing season, or -- yes,

16 at the end of the growing season.

17 So, or the harvest season. So,

18 that obviously, has changed. We're now

19 talking about this not being a plastic, even

20 though I reiterate again, that the industry

21 itself has called this thing a bio--plastic.

22 I think at the end of the day,
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1 legally, we're going to find that this will be

2 called a plastic, whether we rename it or not.

3 You know, if someone chooses to

4 sue on this material down the road, there will

5 be no question, in my view, that this will be

6 deemed a plastic.

7 So, it's within our

8 responsibility, I believe, to try to manage

9 this thing, within the frame work of the law,

10 which -- and get it on the market, because I

11 believe the product we're -- that would --

12 that I believe would at least, one, would

13 qualify would meet this standard, at least in

14 terms of most of its applications at this

15 time, is the -- is our -- does suggest that

16 biodegradation within the growing or harvest

17 season, by the end of the growing or harvest

18 season, with it -- is the one year time frame

19 within the statute.

20 There may be some outliers there. 

21 The certifiers can manage those outliers, in

22 the short term. If we find out through more
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1 and more experience, that in fact, that cannot

2 be done, they can come back with a petition to

3 expand on that. By then, we'll have more

4 data.

5 But we have gotten a foot-hold

6 with this. We will be forward thinking. We

7 will be reducing plastic substantially, but we

8 wouldn't be trying to get the horse back in

9 the barn, after the door was open.

10 So, that is my -- I just wanted to

11 explain my philosophy, my sort of strategy

12 would be to start narrow, limit the

13 uncertainties to the degree that we can, build

14 on that over time, as we get more data coming

15 in.

16 So, in that respect, I would like

17 to propose, I know this isn't a form of

18 proposal, Barry, but I'd like people to

19 consider putting back in, that language at --

20 let's see, let's just see, on the last 'E'.

21 The original language for 'E' was,

22 "Grower must take appropriate actions to
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1 ensure complete degradation at the end of each

2 growing or harvest season."

3 Now, having said that, I'd like to

4 hear, if anybody has a comment in response to

5 that, I'd like to hear it, but I'm also

6 interested in hearing from the program on this

7 element of our proposed listing motion. 

8 You know, what are the

9 constraints, given the law, given the nature

10 of this material? What are the constraints,

11 in terms of removal equals degradation, equals

12 one year, et cetera?

13 I hope that is clear. I just want

14 to throw that out. Thank you.

15 CHAIRPERSON FLAMM: Mac? Okay,

16 Jean, you had a follow up question?

17 MS. RICHARDSON: Yes, and I tend

18 to agree with you Jay, actually, it would be

19 good to see some -- the careful use of that

20 'end of the growing season phrase'.

21 But do we need the word 'complete'

22 in the last sentence, under 'E'? I'm not
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1 certain about that, either, quite frankly.

2 I mean, but let me tell you from

3 the point of view, if I am the inspector,

4 because I think if we're going to make

5 proposals, that have to be able to be verified

6 in the field, if that grower is utilizing the

7 bio-mulch, this year and next year, in the

8 same field, before they move into, perhaps

9 some different kind of rotation, from a

10 verifying point of view, it's going to be very

11 difficult for me to be sure, when I go into

12 that field, is this mulch a little tiny bit

13 that I might see, left from this year or last

14 year?

15 So, from the -- so, I do think we

16 have to be careful, if we're going to make

17 language, that you've got to say how are we

18 going to have that verified in the field, in

19 that -- at the end of that growing season?

20 Having seen the mulch being used

21 all over New England, I mean, obviously, if

22 the farmer is not going to use it in the same
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1 field for two crops in a row, or two growing

2 seasons in a row, then it wouldn't be an

3 issue.

4 But if they -- but you know, we

5 don't dictate their rotation that they have.

6 CHAIRPERSON FLAMM: Yes, I'll call

7 on Tracy next, and then Harold, but I've got

8 to remind the Board, we do have a motion on

9 the floor. So, let's keep the discussion

10 germane to the motion that's on the floor, and

11 we may -- and then if you have a proposal and

12 want to amend the motion, we have a procedure

13 for doing that.

14 But I'm just saying, this is not a

15 complete free-wheeling discussion, because

16 we've done that previously, in Committee, and

17 I think we've got to get some closure on this,

18 and with that, Tracy, would you proceed?

19 MS. FAVRE: I was going to only

20 ask the question, if we have a standard, which

21 it looks like 90 percent biodegradable per ISO

22 17556 or ASTM 5988, is there some description
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1 in there, that describes what degradation

2 would be, that would also be applicable for

3 the field verification, rather than using some

4 word that is absolute?

5 I mean, is there some criterion

6 that is used? No, I'm seeing 'no'.

7 CHAIRPERSON FLAMM: So, shaking

8 the head, but that doesn't make it on the

9 record. So, you know, yes, Zea or Jay, would

10 you answer the question Tracy posed?

11 MS. SONNABEND: No, that 90

12 percent is for products being tested in the

13 controlled environment of the standard

14 testing, not for verification in the field,

15 because you would never be able to assess what

16 90 percent was, in the field situation.

17 CHAIRPERSON FLAMM: Harold, I

18 believe you had a question or a comment, I

19 should say.

20 MR. AUSTIN: Yes, I think part of

21 it, too, we mentioned earlier that we have

22 suggested that this be added to our research
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1 priority list.

2 So, I think some of the answers

3 could be sought out through how we pose that

4 research priority project.

5 So, some of these may be some

6 uncertainties, but I agree, we do have a

7 motion on the floor. So, I think we've got

8 some guidelines, that the certifiers and

9 reviewers could be following, as it exists,

10 and if we need to modify that, I think based

11 off of research and information that we do not

12 have at this time, we can better adapt the

13 policy, as we move forward, based off of

14 science, not based off of human assumption.

15 CHAIRPERSON FLAMM: Nick, you have

16 a comment?

17 MR. MARAVELL: Barry, I would

18 respectfully request the chair, a little

19 forbearance, here. I have more than one

20 comment, and I'm certainly willing to give

21 others plenty of opportunity to comment.

22 But I think this is an important
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1 material decision, in that the complete

2 reasoning and rationale of the Board should be

3 put on the record. It should be placed, so

4 that there can be responses to this, later on.

5 So, I ask a little bit of

6 forbearance on this one material, to perhaps

7 extend the discussion, and I would like to

8 introduce a comment, now, is that okay?

9 CHAIRPERSON FLAMM: That's okay. 

10 I was just suggesting, we try to stay at least

11 around the motion, itself.

12 MR. MARAVELL: And I take we --

13 yes, we'll stay within our time constraints.

14 I would like to address a couple

15 of issues, in a little bit of a round-about

16 way, and just say what we're looking at here,

17 and why we're looking at it.

18 In the deliberations to pass the

19 original Organic Foods Production Act of 1990,

20 the statute contains a provision, which

21 clearly states, "If you're going to use

22 plastic mulch, that you remove it at the end
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1 of the year."

2 At that time, the only mulches

3 available were made from petro-chemicals, and

4 that was what was in everybody's mind.

5 So, I just want to state that I

6 don't think there is any intention here, of

7 going back on that original intent of the law,

8 but we have substantially different material

9 to deal with now.

10 Now, I want to deal with the end

11 of the growing season, or the complete

12 degradation issue, and I see it coming about

13 for two reasons, and one of them goes back to

14 the original law, where clearly, there was no

15 intent to leave a black plastic mulch made

16 from petroleum products, down on the ground,

17 year after year, but you would remove it at

18 the end of the growing season.

19 So, part of the rationale of the

20 Committee, in terms of degradation, was to

21 show that the removal of a bio-mulch, and I'm

22 going to just abbreviate here and call it a
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1 bio-mulch film, the removal of a bio-mulch

2 film can be accomplished through the

3 degradation of that film, and I think that --

4 so, that one, put that out as one criteria

5 that we are trying to achieve, in trying to

6 meet a definition that was intended for black

7 plastic coming from petroleum source.

8 On the other side, and now, I'm

9 speaking as a farmer, there is something

10 called organic matter, and organic matter is

11 managed, and I think what, you know, where Mac

12 and I are having a little bit of an issue here

13 is, I don't consider it mandatory, if plow

14 down my corn stover or my cover crop or

15 whatever additions I'm adding to the soil,

16 that it be 100 percent completely bio-degraded

17 at the end of a year or two years.

18 In fact, I consider it sort of a

19 bonus if I have different carbon fractions of

20 most recent to least recent, adequately mixed

21 in an active, biological soil, in the top

22 layer.
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1 And so, I think from an agronomic

2 -- from a farming standpoint, I don't think

3 it's imperative that 100 -- if we were using

4 newspaper, or more appropriately in my case,

5 if we were using straw or stover or other

6 types of materials, that they necessarily be

7 100 percent degradable or 90 percent

8 degradable in a particular period of time.

9 So, having said that, what I would

10 urge the program, is to -- we are trying to

11 fit this into existing law and existing

12 regulation. The regulation contains and

13 additional prescription, not in the statute,

14 with regard to other synthetic mulches.

15 And so, I guess my point here is

16 that if our intent is clear, that we see this

17 as a bio-based mulch, made out of -- now, I'm

18 saying organic matter, but not certified

19 organic matter, but made out of a material

20 that came from recently alive material, if you

21 will, then it might be necessary to review

22 other sections of the regulations, to make
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1 sure that we are -- we have -- and maybe

2 modify those, so that this, in deed, does fit

3 within the program's definition of adequate

4 removal of the synthetic.

5 So, I'm desperately trying here to

6 outline the thinking of the Committee, in

7 putting this forward. Are we creating a

8 conflict, or is this something that the

9 program can accommodate, in terms of the

10 removal of a synthetic mulch?

11 CHAIRPERSON FLAMM: John, you had

12 one.

13 MR. McEVOY: It just seems like

14 that was a question for the program, and we

15 don't see a problem with making the necessary

16 changes, based on what we see in front of us.

17 I mean, just one thing that we see

18 here, if we take your recommendation and go

19 through the regulatory process of review, to

20 ensure that it fits into the complete picture

21 of the regulation.

22 So, for instance, up here, you
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1 have, "Grower must take appropriate actions." 

2 We would change that to 'producer', because we

3 don't define grower in the regulation. We

4 define producer.

5 So, it's things like that, that we

6 do with all of your recommendations, as we go

7 through the proposed rule, as we then put out

8 something that may not be exactly the language

9 that you choose, but it is -- it gets your

10 recommendation.

11 CHAIRPERSON FLAMM: Thank you,

12 Miles. John, you have a comment or a

13 question?

14 MR. FOSTER: So, with respect to

15 my previous comments, and my mellow is getting

16 harshed a little bit here, on the process, can

17 we -- I'd like to call the question on this

18 issue.

19 CHAIRPERSON FLAMM: The question

20 has been called. Is there -- there needs to

21 be a second to the question.

22 MS. RICHARDSON: Second.
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1 CHAIRPERSON FLAMM: The question

2 is to call for a vote, to end discussion.

3 I'll just ask for votes or

4 objections to the question. Any objections?

5 MR. MARAVELL: I would object. I

6 think there is legit -- no, but I'm saying, I

7 would object to the motion, if I were asked. 

8 There's been not adequate discussion, in my

9 mind, yet.

10 CHAIRPERSON FLAMM: Since there is

11 -- I'll rule that since there is an objection

12 to the question, I'll let the question

13 continue, but I would hope we could end this

14 fairly soon, because I think we're covering

15 some ground, again, that was at least been

16 discussed in Committee.

17 I'll recognize Jay, right now.

18 MR. FELDMAN: I'm just trying to

19 get clarity on Nick's question.

20 Looking at the rule, we're talking

21 about 205.206C, "Weed problems may be

22 controlled through six, plastic or other
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1 synthetic mulches, provided that they are

2 removed from the field at the end of the

3 growing season."

4 Miles, I didn't quite understand

5 your response. Maybe I was a little

6 distracted. So, help me out here, I

7 apologize.

8 This is a rule that was adopted by

9 the Board, I mean, it was proposed by the

10 Board, adopted by the program, incorporated

11 into the rule, presumably, and maybe we can

12 get a correction.

13 But in any event, it's a -- in my

14 view, it's a principle of soil management, you

15 know, because when we look at the other

16 elements of 205.206C, we're talking about

17 mulching with fully biodegradable materials,

18 mowing, livestock grazing, hand-weeding and

19 mechanical cultivation, flame, heat or

20 electrical means, or the plastic, provided

21 it's removed. Disease problems may be -- and

22 then 'D', Disease problems.
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1 But in any event, plastic or other

2 synthetic mulches is the last on the list. 

3 You know, obviously, it's not necessarily a

4 prioritized list, but the presumption here is

5 that this is a principle of soil management,

6 that we don't leave synthetics or put

7 synthetics into the soil, and that if we do

8 use synthetics as mulches, we remove them.

9 This is, again, what I'm talking

10 about here is specific to weed problems, we're

11 talking weed management.

12 So, I mean, I'm not sure how much

13 leeway the program really has, to redefine

14 what we remove or don't remove, in the terms

15 of synthetic mulches.

16 The Committee, the Subcommittee

17 has been working under the presumption that

18 first of all, the material does degrade within

19 the time frame of the law, and of this rule,

20 and that removal or degradation equals

21 removal.

22 To change this underlying
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1 principle is what I thought I heard you say,

2 to change this principle that synthetic

3 mulches may remain in the soil, or i.e., not

4 degrade, as ASTM suggests they would degrade

5 and as the manufacturer testified to their

6 degradation, seems to me, over-reaching, if

7 I'm interpreting this correctly, over-reaching

8 the intent of the existing standard, as

9 supported by the NOSB.

10 MR. McEVOY: Okay, it think it

11 seems like your question is, is whether or not

12 205.206C is relevant, and it definitely is

13 relevant to this particular proposal.

14 If this proposal is adopted and is

15 a final recommendation from the Board, then

16 that is our responsibility, is to take that

17 and then add this particular material to the

18 national list, and make sure that it doesn't

19 conflict with other parts of the regulations.

20 So, that particular clause that

21 you're referring to would have to be amended,

22 most likely. I mean, looks like it, in terms
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1 of, to be compliant.

2 So, what we do is, we take your

3 final recommendation and make changes to

4 205.206C, so that it is compliant with the

5 final recommendation of this Board, that is

6 recommending that this particular substance is

7 added to the national list.

8 It's a normal part of our process,

9 to do that.

10 MR. FELDMAN: Okay.

11 CHAIRPERSON FLAMM: Okay, can you

12 make one more -- can you wrap up with another

13 question? We have a couple other people who

14 want to talk.

15 MR. MARAVELL: Okay, well, no, but

16 this is direct follow up on this, but I can --

17 CHAIRPERSON FLAMM: Well, if --

18 MR. MARAVELL: It's short.

19 CHAIRPERSON FLAMM: I'll take

20 that, you make yours now, if it's a direct on

21 this.

22 MR. MARAVELL: Yes, in effect, I'm
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1 going to restate this another way. We already

2 saw that fully biodegradable mulches are

3 permitted. We didn't specify in that, you

4 know, they can't be, it's only non-synthetic

5 fully biodegradable mulches are permitted, and

6 I think where we're trying to get, in my mind,

7 Jay, is that this really qualifies.

8 This is a material that was never

9 really anticipated in the formation of law or

10 the regulation. So, this -- we're now finding

11 a material that is fully biodegradable.

12 So, I could almost make the

13 argument that it's covered above, as a fully

14 biodegradable mulch, but I do certainly not

15 want to second guess the program on that.

16 So, that is where I'm heading with

17 this, and I think it's important to have this

18 discussion.

19 CHAIRPERSON FLAMM: Mac? Mac

20 doesn't have any further questions. Nick, do

21 you still have a question? Comment?

22 MR. MARAVELL: I have one closing
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1 comment. I say, I have one closing comment.

2 CHAIRPERSON FLAMM: You have a

3 closing comment?

4 MR. MARAVELL: Yes, if you --

5 CHAIRPERSON FLAMM: Okay, and then

6 we're going to proceed to -- if nobody has any

7 comment or question, after Nick makes his

8 final comment, we'll proceed to the vote on

9 the motion.

10 MR. MARAVELL: Yes, I would simply

11 like to thank Carmela and Zea, for sticking

12 with us, through all of this. This has gone

13 through many twists and turns, and they have

14 valiantly kept us on track, and steered the

15 course for us.

16 I would also like to thank all the

17 members of the public, who have commented on

18 this, because this is what we need, as a full

19 and open discussion, when we're trying to move

20 forward, and I really feel that we have

21 benefitted greatly from the public comment.

22 MR. FELDMAN: May I have a closing
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1 comment, too, just one second?

2 CHAIRPERSON FLAMM: You're going

3 to vote.

4 MR. FELDMAN: I'm going to vote,

5 but I'm going to -- 

6 CHAIRPERSON FLAMM: Jay, go ahead.

7 MR. FELDMAN: I also want to thank

8 the Subcommittee and all the commenters for

9 participating in this process. 

10 I really feel like we're close on

11 this. Unfortunately, I'm not going to be able

12 to support this with these last outstanding

13 questions.

14 But please don't take that as my

15 lack of enthusiasm for getting to a place

16 where this material can be used safely and

17 effectively.

18 Again, I appreciate everybody's

19 work on this.

20 CHAIRPERSON FLAMM: We're ready to

21 begin the vote with -- on the motion, it's

22 been a long time, so, anybody -- is everybody
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1 clear on what we're voting on?

2 I'm taking the silence is that

3 everybody is clear on the motion. 

4 MR. BONDERA: Barry?

5 CHAIRPERSON FLAMM: Yes? 

6 MR. BONDERA: Sorry, I was raising

7 my hand, sorry. I just want to verify that

8 the motion, even though the screen shows it

9 with Item D, "Must be produced without

10 engineered nano-tech materials and," that's

11 not -- that is not the motion being voted

12 upon.

13 CHAIRPERSON FLAMM: That was --

14 MR. BONDERA: That was removed and

15 now there is --

16 CHAIRPERSON FLAMM: That was

17 removed and --

18 MR. BONDERA: There is no -- yes,

19 I just want to --

20 CHAIRPERSON FLAMM: The motion on

21 the floor does not contain 'D'.

22 MR. MARAVELL: Barry, also, when
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1 we read the motion, with regard to bio2 technology concerns, it was 'and/or', and I

3 don't know if that -- does that -- is that on

4 the screen? Oh, it's on the screen? Okay.

5 CHAIRPERSON FLAMM: Any other

6 questions about the vote, the motion we're

7 voting on.

8 Hearing none, I'll proceed with

9 starting the vote with Jay.

10 MR. FELDMAN: No.

11 MS. SONNABEND: Yes.

12 MR. STONE: Yes, sir.

13 MS. FULWIDER: Yes.

14 MR. AUSTIN: Yes.

15 MS. FAVRE: Yes.

16 MS. BECK: Yes.

17 MR. FOSTER: Yes.

18 MR. DICKSON: Yes.

19 MS. RICHARDSON: Yes.

20 MR. WALKER: Yes.

21 MR. BONDERA: No.

22 MS. TAYLOR: No.
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1 MR. MARAVELL: Yes.

2 CHAIRPERSON FLAMM: The Chair

3 votes yes. Three, let's see, 12 'yes', three

4 'no'. The motion passes.

5 That concludes the Crop Session. I

6 think we deserve a little break, 15 minute

7 break, and then we'll move to handling

8 proposal. 

9 (Whereupon, the above-entitled

10 matter went off the record at 11:06 a.m. and

11 resumed at 11:31 a.m.)

12 CHAIRPERSON FLAMM: Board Members,

13 please take your seat.

14 Okay, the Board's back in session. 

15 Our next business matter is the Handling

16 Subcommittee's proposal that was deferred on

17 nucleotides.

18 John Foster, Chair, would you

19 proceed, please?

20 MR. FOSTER: Yes, we have one

21 remaining item from our agenda yesterday, and

22 that's the subject of nucleotides, it was
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1 petitioned item, I believe Lisa Brines, if I

2 speak slowly, has time to -- you already

3 introduced it.

4 Lisa, you've already introduced

5 the material of nucleotides. You need not do

6 it again, excellent.

7 One remaining material. Again,

8 I'll give them on to Zea, who did some heavy

9 lifting on this, and Michelle has already put

10 up the current, what will be the current

11 motion on the screen. So, Zea, if you would.

12 MS. SONNABEND: Thank you, John. 

13 As we discussed yesterday, the Committee,

14 based on public comment, has -- is likely to

15 change our vote because we think the

16 nucleotides are non-synthetic.

17 We held this back from voting

18 yesterday, though, primarily to make sure that

19 we were creating a listing motion in the right

20 way, and so, we have added, since yesterday,

21 to the listing motion, instead of just saying,

22 "Motion to list nucleotides for inclusion on
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1 the list," we're saying, "Nucleotides as

2 petitioned," to add to the list.

3 The reason for this is, there are

4 several different nucleotides and their salts. 

5 They are spelled out in the TR, and we just

6 want to -- and in the petition, and we want to

7 make sure that the correct reference to the

8 correct materials is given.

9 So, with that, I'll go ahead and

10 make the motion to classify nucleotides as

11 petitioned, as synthetic.

12 CHAIRPERSON FLAMM: Do we have a

13 second?

14 MR. BONDERA: I'll second that.

15 CHAIRPERSON FLAMM: Okay,

16 discussion? Jay?

17 MR. FELDMAN: Thank you. So, I've

18 heard some discussion about how this is

19 manufactured, and I wanted, if you could -- I

20 don't know, Zea, you may not be able to do

21 this, but if somebody could enlighten us, as

22 to the manufacturing process and the
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1 crystallization process, and how people are

2 thinking about that, and whether or not it's

3 viewed as a synthetic process.

4 If you go to line 258 of the

5 technical review, it says, "Nucleotides are

6 processed and prepared for packaging using

7 filtration crystallization, centrifuging,

8 drying, sizing, milling and blending."

9 So, if you could help me, or just

10 get on the record, at least, what that process

11 is, so that we understand it to be a natural

12 process, as some people have described it.

13 MS. SONNABEND: Well, I would

14 refer you to OMRI's and Rich Theuer's comments

15 on this, and I'm looking for them, but does

16 someone else on the Board have them more

17 accessible, and could explain to Jay?

18 MR. FOSTER: I'm looking for them. 

19 I'm trying to get there, too.

20 MS. SONNABEND: Okay, or we could

21 call up an audience member, although Lindsey

22 has left, but there are other audience members
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1 who could explain it, if that's acceptable to

2 Barry.

3 CHAIRPERSON FLAMM: What would be

4 the --

5 MS. SONNABEND: Jay is asking for

6 an explanation of how those terms that he just

7 read off in the processing of it, made it non8 synthetic, and it was in our written comments,

9 but it's going to take us a bit to find them,

10 but someone from the audience, such as

11 Gwendolyn or -- no, or someone else who maybe

12 has the handling comment.

13 Okay, Emily, thank you.

14 MR. FELDMAN: Thank you. 

15 CHAIRPERSON FLAMM: Thank you,

16 Emily. You may proceed.

17 MR. FELDMAN: I can read in the

18 record, what OMRI said, now.

19 Just so the Board is aware of

20 this, they restated that crystallization is

21 used in the manufacturing of nucleotide, in

22 the final mix, classifying such materials that
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1 go through this process, as synthetic because

2 the resulting material was created via

3 synthetic systems, to generate large volumes,

4 is not in keeping with the criteria set forth

5 in OMRI' synthetic/non-synthetic decision

6 tree, nor with common understanding of the

7 definition of synthetic.

8 "Using the same reasoning on a

9 number of other materials, such as yeast

10 extract, some amino acids, citric acid, et

11 cetera, these substances would have to be

12 considered synthetic because these substances

13 are generated in large volumes via synthetic

14 systems."

15 We asked the NOSB to reconsider

16 this classification for the sake of

17 consistency.

18 So, that answers OMRI's position. 

19 If Lindsey were here, I would just ask a few

20 more questions about what that crystallization

21 process is, but thank you.

22 MS. BROWN-ROSEN: Can you hear me? 
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1 Well, our concern was just that when we looked

2 back at the petition, that I agree that the,

3 you know, the explanation is basically

4 biological processes of enzymes extracting the

5 yeast, but the actual final product, which I

6 believe the petitioner -- no, I'm not sure if

7 they're -- did they comment or not? I don't

8 know if they did.

9 But anyway, the petition actually

10 asked to include nucleotides, isolated from

11 yeast RNA, hydrolyzate on the national list,

12 and specifically, it says it requested the

13 listing to be nucleotides from yeast, RNA

14 hydrolyzate, identified as the following, and

15 their sodium salt. So, then it listed the

16 five different nucleotides.

17 So, once, you know, these yeast

18 bits are extracted into the adenosine,

19 cytodine, guanosine, uridine, inosine-5, then

20 you know, what they're actually asking to be

21 listed is adenosine diphosphate and sodium

22 salt.
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1 So, that process has not been like

2 well elucidated in the TR or in the comments,

3 and we feel like there are similar salts of

4 other possibly natural materials that are on

5 the national list as synthetic, as well. That

6 was the concern there.

7 CHAIRPERSON FLAMM: Yes, I'll call

8 on you.

9 MS. SONNABEND: But Emily, isn't

10 that creation of the salt is the

11 crystallization that Jay is referring to,

12 because it's just precipitating out at a

13 certain saturation point.

14 MS. BROWN-ROSEN: You know, it's

15 not clear. We don't have a clear definition

16 or description of the final processing phase

17 there, I don't think.

18 MS. SONNABEND: What do you

19 suggest we do?

20 MS. BROWN-ROSEN: That's a

21 judgment call, to you. If you think that

22 renders it synthetic or not, it's -- you know,
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1 there seems to be that it's a salt formed

2 through -- you know, a basically natural

3 extraction, but then there is a salt form. 

4 So, you don't have -- I mean, it's

5 based on your own recommendation on

6 classification.

7 CHAIRPERSON FLAMM: Emily, could

8 you --

9 MS. BROWN-ROSEN: It's up to you.

10 CHAIRPERSON FLAMM: Could you

11 repeat what you said, and speak up? At least,

12 I couldn't hear it, so, we can be sure we get

13 it on the record.

14 MS. BROWN-ROSEN: Just saying that

15 it's -- you know, there is a lot of -- this is

16 sort of a borderline call. You know, it's

17 extracted from a natural product, using a

18 biological process. So, that is all considered

19 non-synthetic, in your position.

20 It's just that the formation of

21 the final salt, there must be an added

22 synthetic phosphate source or sodium source,
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1 to get the final salt.

2 So, normally, that is considered a

3 chemical reaction, but it's, you know, not a -

4 - you know, maybe you might not consider that

5 a fundamental change. It's up to you guys.

6 CHAIRPERSON FLAMM: Anymore

7 questions? Discussion on the topic? Zea?

8 MS. SONNABEND: So, I know we

9 decided that saying 'as petitioned' would

10 cover this issue, but now, I'm feeling that if

11 we -- no matter which way we vote, it will be

12 confusing to the likes of OMRI and other

13 professionals, who are trying to look at these

14 materials.

15 And so, now, I feel like maybe we

16 need to change the classification motion to

17 say, "Motion to classify nucleotides

18 (including their salts) as petitioned, as

19 synthetic." So, that's extra clear, that that

20 is what our concern may be. Does that make

21 sense to anyone?

22 CHAIRPERSON FLAMM: John, do you
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1 have a comment? No? 

2 MS. SONNABEND: I made the motion,

3 so, if the second agrees, I guess I'll amend

4 my motion.

5 CHAIRPERSON FLAMM: Why don't you

6 just withdraw your motion and restate it?

7 MS. SONNABEND: Okay, I'll

8 withdraw my motion and make this new motion.

9 CHAIRPERSON FLAMM: So, would you

10 state your new motion?

11 MS. SONNABEND: Okay,

12 classification motion, "Motion to classify

13 nucleotides (including their salts) as

14 petitioned, as synthetic."

15 CHAIRPERSON FLAMM: Is there a

16 second?

17 MR. BONDERA: I'll second.

18 CHAIRPERSON FLAMM: It's been

19 moved and seconded. In a moment, I'll -- it's

20 moved to classify nucleotides -- what is this? 

21 Including their salts, as petitioned, as

22 synthetic, is that correct? Further
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1 discussion? Is there further discussion? Do

2 you want to ask a question? 

3 MS. SONNABEND: Tracy has her hand

4 up.

5 CHAIRPERSON FLAMM: Tracy?

6 MS. FAVRE: Zea, as you know,

7 we've gone back and forth on this, in the

8 Subcommittee, a couple of times, and I guess

9 I'm a little confused now, in regards to the

10 process, specifically, that has caused us to

11 sort of reverse this decision.

12 CHAIRPERSON FLAMM: Zea, would you

13 like to respond to that question? 

14 MS. SONNABEND: I don't consider

15 it reversed, before we vote, but what caused

16 us is, the department flagging it, that it

17 wasn't properly annotated to include the salt

18 forms.

19 CHAIRPERSON FLAMM: Does that

20 answer your question, Tracy?

21 Further questions? If not, we'll

22 proceed with the vote on the classification
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1 motion, beginning with Zea.

2 MS. SONNABEND: Abstain.

3 MR. FELDMAN: We can't vote, if we

4 abstain.

5 MS. SONNABEND: You don't have to

6 abstain. I will.

7 CHAIRPERSON FLAMM: Everybody else

8 abstains? 

9 MS. SONNABEND: Okay, yes.

10 MR. STONE: I guess yes.

11 MS. FULWIDER: Yes.

12 MR. AUSTIN: Yes.

13 MS. FAVRE: Abstain.

14 MS. BECK: Yes.

15 MR. FOSTER: No.

16 MR. DICKSON: Abstain.

17 MS. RICHARDSON: Abstain.

18 MR. WALKER: Yes.

19 MR. BONDERA: Yes.

20 MS. TAYLOR: Yes.

21 MR. MARAVELL: Yes.

22 MR. FELDMAN: Yes.
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1 CHAIRPERSON FLAMM: And the Chair

2 votes yes. We have a record number of

3 abstentions, I think. I'll give you the count

4 on whether it passed, in a moment. I've got

5 to look at this tally, what constitutes -- 

6 I have to refer to the table, to see

7 that. What is your tally? Okay, give me the

8 count again.

9 MS. FULWIDER: Eleven. 

10 CHAIRPERSON FLAMM: Eleven 'yes'.

11 MS. FULWIDER: One 'no'.

12 CHAIRPERSON FLAMM: One 'no', and

13 three abstentions. The motion passes. Sorry

14 for the time element, but I had to double15 check the chart that we had the right amount

16 for passing.

17 MS. SONNABEND: Okay, in light of

18 it passing, Barry, the listing motion needs to

19 be changed back to, "Motion to list

20 nucleotides, including their salts, as

21 petitioned, for inclusion on 205.605B, instead

22 of A, allowed for infant formulas labeled
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1 'organic' or made with organic specific

2 ingredients or food groups, only in the

3 organic and made with organic categories."

4 CHAIRPERSON FLAMM: Do we have a

5 second?

6 MR. FOSTER: I'll second.

7 CHAIRPERSON FLAMM: It's been

8 moved and seconded. If I can -- I'll make

9 sure I've got all the changes, before

10 restating the motion.

11 MS. SONNABEND: Michelle needs to

12 remove the strike out from B. Okay, I see,

13 there is a new B.

14 So, yes, I believe that is

15 correct.

16 CHAIRPERSON FLAMM: The motion is

17 to list nucleotides, including their salts, as

18 petitioned for inclusion on 205.605B, allowed

19 for infant formulas labeled 'organic' or made

20 with organic specified ingredients or food

21 groups, only in the organic and made with

22 organic categories."
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1 Discussion on the motion? No

2 discussion? 

3 Okay, we will proceed with the

4 vote, if there is no discussion. Starting the

5 voting with Mac.

6 MR. STONE: Yes, sir.

7 MS. FULWIDER: Yes.

8 MR. AUSTIN: Yes.

9 MS. FAVRE: No.

10 MS. BECK: Yes.

11 MR. FOSTER: Yes.

12 MR. DICKSON: Yes.

13 MS. RICHARDSON: Yes.

14 MR. WALKER: No.

15 MR. BONDERA: No.

16 MS. TAYLOR: No.

17 MR. MARAVELL: No.

18 MR. FELDMAN: No.

19 MS. SONNABEND: No.

20 CHAIRPERSON FLAMM: And the Chair

21 votes 'no'. Seven 'yes', eight 'no', the

22 motion fails.
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1 I believe that completes the

2 Handling Subcommittee options and actions.

3 MR. FOSTER: Yes, it does, and

4 again, I'd like to thank the Subcommittee for

5 a lot of hard work, lot of hours on conference

6 calls, and again, the program, for their

7 excellent support.

8 CHAIRPERSON FLAMM: We'll break

9 for lunch now, and return at 1 o'clock. Thank

10 you.

11 (Whereupon, the above-entitled

12 matter went off the record at 11:52 a.m. and

13 resumed at 1:18 p.m.)

14 CHAIRPERSON FLAMM: The meeting

15 will come to order. The next item on the

16 agenda is the -- is for the Policy Committee

17 and to address their deferred proposal on

18 conflict of interest, and I'll turn the gavel

19 and the microphone over to the Chair Colehour

20 Bondera.

21 MR. BONDERA: Thank you very much,

22 Barry. At this moment, I request that in order
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1 for us to best be able to address the conflict

2 of interest proposed recommendation that is on

3 the -- that was presented yesterday, that the

4 Policy Development Subcommittee have a short

5 meeting to discuss our options.

6 So, I hereby request 10 minutes to

7 do that, if you can so.

8 CHAIRPERSON FLAMM: The request is

9 granted.

10 (Whereupon, the above-entitled

11 matter went off the record at 1:19 p.m. and

12 resumed at 1:30 p.m.)

13 MR. BONDERA: Board Members,

14 please be seated.

15 Thank you very much. Thank you

16 all, for the time. I apologize for the

17 impacts of things that needed to be further

18 considered.

19 So, at this point in time, because

20 -- the Policy Development Subcommittee just

21 got together, and we're dealing with the

22 topic, which is on the table, which is our
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1 conflict of interest proposed recommendation,

2 and because of the fact that the conflict of

3 interest document that was submitted for

4 public input and to be considered has received

5 -- and also, from NOSB members, has received

6 such substantial changes, at this point in

7 time, from where it was, and to properly deal

8 with that fact, and separately and in addition

9 from talking to the program people on this

10 topic, we have decided that the best approach

11 is what I am going to do at this moment, which

12 is to table the motion, table the topic of the

13 conflict of interest and pull it off of our

14 plate, at this point in time.

15 So, that said, I would like to

16 turn the gavel back to you, Barry. Thank you.

17 CHAIRPERSON FLAMM: Thank you,

18 Colehour, and I understand that completes not

19 only the Policy Subcommittee's work and

20 proposals, that we have no other deferred

21 proposal for consideration and voting? Am I

22 correct?
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1 I think we've completed -- yes,

2 Zea?

3 MS. SONNABEND: I would just like

4 to say that I think the public communication

5 portion about the open docket should come back

6 up at this meeting, that part of it, because

7 I think we really need an open docket, and

8 we're delaying it for six more months.

9 CHAIRPERSON FLAMM: I understand

10 that has been discussed, but it's going to be

11 -- probably be somewhat reworked and brought

12 up at the next Board meeting.

13 Okay, that completes the work on

14 the proposals, and I think we're -- the next

15 order of business is election of officers.

16 So, I'll turn that over. Wendy,

17 are you going to distribute the ballots?

18 MS. FULWIDER: I have already

19 distributed the ballots. You all have three

20 cards. So, we'll use one for Chair, one for

21 Vice Chair and one for Secretary, and it

22 doesn't matter which one.
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1 CHAIRPERSON FLAMM: And just, if I

2 could, a reminder of the procedures.

3 There will be separate votes on

4 the -- the first vote will be for the Chair,

5 and after the vote is taken and tallied and

6 the winner announced, then we'll proceed to

7 the Vice Chair position, just for

8 clarification. That's the order, and I don't

9 have any voting cards.

10 MR. McEVOY: Do you not need to

11 nominate people for these positions, to start

12 with?

13 CHAIRPERSON FLAMM: Yes.

14 MR. McEVOY: Okay.

15 CHAIRPERSON FLAMM: We'll have to

16 have nominations. 

17 MR. BONDERA: Excuse me, Wendy.

18 CHAIRPERSON FLAMM: Okay,

19 Colehour?

20 MR. BONDERA: Yes, I unfortunately

21 need to not turn this ballot, which turned

22 into a card from a friend, who came to find
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1 me, into a ballot. So, I wonder, can I please

2 request a replacement and leave this on the

3 table? I apologize. Thank you.

4 CHAIRPERSON FLAMM: I thought you

5 were going to make a nomination, Colehour.

6 MR. BONDERA: I apologize, that's

7 why -- so, this is sitting here. I'm not

8 double-balloting. It will still be sitting

9 here, sorry. Thank you.

10 CHAIRPERSON FLAMM: Okay, thank

11 you. So, is there a nomination for the

12 position of Board Chair? Zea?

13 MS. SONNABEND: I'd like to

14 nominate Mac for Board Chair.

15 CHAIRPERSON FLAMM: Mac, you've

16 been nominated for Board Chair. Do you accept

17 the nomination?

18 MR. STONE: Could we take about a

19 10 minute break for me to think about that?

20 CHAIRPERSON FLAMM: Chair refuses.

21 MR. STONE: I'll accept that.

22 CHAIRPERSON FLAMM: Okay, is there
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1 further -- further nominations for Board

2 Chair?

3 I think the normal procedure is,

4 ask that question three times. I only got two

5 more.

6 Is there nomination for Board

7 Chair?

8 One more time, is there nomination

9 for Board Chair?

10 Hearing none, we just saved a

11 bunch of paper and cardboard. 

12 Congratulations.

13 We can proceed for the nomination

14 for Vice Chair. Nomination for Vice Chair?

15 MS. FULWIDER: There is a

16 question.

17 CHAIRPERSON FLAMM: Question? I'm

18 sorry? This glare, I can't see, right now,

19 the people. Who?

20 MS. FULWIDER: Miles.

21 MR. McEVOY: I think you still

22 need to vote, or at least do an acclamation
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1 for --

2 CHAIRPERSON FLAMM: By

3 acclamation, that's what I -- I didn't use the

4 proper word, I'm sorry, couldn't think of it.

5 But yes, it was by acclamation. 

6 So, with no other -- with three requests for

7 nomination, if there is no other nomination,

8 you can declare the vote by acclamation. 

9 That's what I did, but I might have missed the

10 terminology.

11 MR. BONDERA: That is correct.

12 CHAIRPERSON FLAMM: Yes, I'm

13 having -- I'm getting blinded, looking off

14 that way. As much as I like the sunshine, I

15 couldn't see.

16 Are we all clear then? Mac is the

17 new Chair, and then we -- I'm looking for a

18 nomination for Vice Chair.

19 Nick, I believe you had your hand

20 up?

21 MR. MARAVELL: Yes, I nominate

22 Colehour.
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1 CHAIRPERSON FLAMM: Colehour,

2 you've been nominated for Vice Chair. Do you

3 accept the nomination?

4 MR. BONDERA: Yes, I will accept

5 that nomination. Thank you, Nick.

6 CHAIRPERSON FLAMM: Is that 'yes'?

7 MR. BONDERA: Yes, it was.

8 CHAIRPERSON FLAMM: Okay, and I

9 saw that Jennifer had her hand up.

10 MS. TAYLOR: I was going to

11 nominate the same person.

12 CHAIRPERSON FLAMM: All right,

13 Harold?

14 MR. AUSTIN: I nominate John

15 Foster.

16 CHAIRPERSON FLAMM: John Foster

17 has been nominated for Vice Chair. John, do

18 you accept the nomination?

19 MR. FOSTER: I accept.

20 CHAIRPERSON FLAMM: Okay, we have

21 -- at this time, we have Colehour Bondera

22 nominated for Vice Chair and John Foster,
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1 nominated for Vice Chair. 

2 Any additional nominations? Any

3 additional nominations? Any additional

4 nominations?

5 Okay, not hearing any, I think we

6 can vote.

7 I have counted the votes and it's

8 been verified by the program, by Miles, and

9 John Foster is the next Vice Chair. 

10 Congratulations, John.

11 Okay, we have the important

12 position of Secretary to be elected now. Do

13 we have -- is there a nomination for Secretary

14 of the Board? Harold?

15 MR. AUSTIN: I'd like to nominate

16 Wendy.

17 CHAIRPERSON FLAMM: Wendy, you've

18 been nominated to serve as Secretary, for a

19 third term. Do you accept?

20 MS. FULWIDER: I accept.

21 CHAIRPERSON FLAMM: Are there

22 further -- is there additional nominations? 
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1 Yes, Wendy?

2 MS. FULWIDER: I'm going to

3 nominate Calvin.

4 CHAIRPERSON FLAMM: Calvin has

5 been nominated to serve as Secretary. Calvin,

6 do you accept the nomination?

7 MR. WALKER: Wendy, you are

8 running?

9 MS. FULWIDER: Yes, but I feel

10 that you should run, as well.

11 MR. WALKER: I decline. I

12 respectfully decline.

13 MS. FULWIDER: You're hurting my

14 feelings.

15 CHAIRPERSON FLAMM: Calvin, I

16 understand you do not accept the nomination to

17 be Secretary?

18 MR. WALKER: That's correct, I

19 would not want to run against my Chair of the

20 Livestock Committee.

21 CHAIRPERSON FLAMM: Is there any

22 further nominations for the position of
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1 Secretary?

2 Is there any further nominations

3 for the position of Secretary?

4 Yes, would you like to make a

5 nomination for Secretary?

6 MR. MARAVELL: Well, what I'd like

7 to do is just to point out the general policy

8 of the Board, and I think it may be in the

9 policy and procedures manual, that we

10 encourage a turnover, and I think that's what

11 Wendy is indicating here, and I would ask

12 Calvin to reconsider.

13 But I'm just going to indicate

14 that the policy is generally, to encourage,

15 you know, not a lot of consecutive terms.

16 So, Calvin, would you possibly

17 reconsider?

18 CHAIRPERSON FLAMM: I could -- I

19 just reread the procedures of the manual

20 position. Consecutive terms are allowed,

21 however, I would say that more than two terms

22 aren't, by the language, not particular
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1 encouraged. But it's not -- no prohibited.

2 I just wanted to clarify that. 

3 It's not prohibited.

4 At any case, I want -- okay, I'm

5 asking for one more time, for nominations. 

6 Wendy, do you have a nomination?

7 MS. FULWIDER: Under, you know,

8 the situation, you know, if Calvin is not

9 going to run against me, I feel that I should

10 decline.

11 CHAIRPERSON FLAMM: So, we've gone

12 from two nominations now, to no nominations. 

13 Most unusual, I would say, at elections, but

14 okay, I'm going to accept that Wendy has

15 declined. 

16 So, I'm going to ask for

17 nominations for the office of Secretary. 

18 Colehour?

19 MR. BONDERA: Yes, I would like to

20 nominate Calvin to serve in that role.

21 CHAIRPERSON FLAMM: Calvin?

22 MR. WALKER: I accept.
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1 CHAIRPERSON FLAMM: Will you

2 accept the nomination?

3 MR. WALKER: Yes, sir.

4 CHAIRPERSON FLAMM: Okay, Calvin

5 has accepted the nomination to be Secretary of

6 the Board. Is there additional nominations? 

7 John, do you have a nomination?

8 MR. FOSTER: I feel like there is

9 a full circle thing here, that needs to

10 happen, and I'm going to nominate Wendy, and

11 she can do as she wishes.

12 CHAIRPERSON FLAMM: Wendy, are you

13 going to accept or decline that?

14 MS. FULWIDER: I will accept,

15 providing Calvin does not decline.

16 CHAIRPERSON FLAMM: Most unusual.

17 MR. WALKER: I will not decline.

18 CHAIRPERSON FLAMM: Okay, so, as I

19 understand, we have Calvin has accepted the

20 nomination to serve as Secretary, and Wendy

21 has accepted the nomination to serve as

22 Secretary. Do we have further nominations?
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1 Okay, hearing none, I'll ask it,

2 now. Do we have further nominations? Do we

3 have further nominations?

4 Hearing none, we'll proceed with

5 the vote.

6 I've counted the votes for the

7 position of Secretary of the Board, and it's

8 been confirmed by the program, by Miles, and

9 Calvin has been elected Secretary, and

10 congratulations, Calvin.

11 I want to extend my thank you to

12 Wendy, for her great service over two years. 

13 That's a tough job, so, thank you very much,

14 Wendy.

15 At this point in time, I'd like to

16 restart a tradition that was on the Board when

17 I joined it, and that is that I pass the gavel

18 to the new Chair. 

19 I want to thank the Board for

20 their honoring me with serving as your Chair,

21 and I appreciate all the cooperation and good

22 work you done, and now.
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1 MR. STONE: The first order of

2 business is not only thanking Barry, and I'm

3 humbled by the shoes that he has filled, but

4 Barry, you've got a new name tag, and we'll

5 have this one framed and sent to the house for

6 you.

7 CHAIRPERSON FLAMM: I love that,

8 and you can't believe how truthful that is. 

9 MR. STONE: Well, it's again,

10 Barry, I know that following your footsteps

11 of, you know, a lot of people were very

12 comfortable with your leadership and steady

13 guidance. 

14 So, I do have a strong sense of

15 responsibility, obviously. There is a lot of

16 very strong and passionate and caring people,

17 and we can agree to disagree, but then we

18 agree to go forward, in a unified voice, after

19 some -- we made some very tough votes this

20 past week, but we still have to look forward

21 and at the end of the day, come together and

22 do what we all think is best for the industry,
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1 if you will.

2 I think we have work plans, next. 

3 I don't know, Michelle, if you have that to

4 put up, or if each Subcommittee Chair has

5 their own, and maybe we'll just go in the same

6 order that they're in on the screen.

7 Looks like starting with

8 certification, Joe, if you want to reference

9 the document.

10 MR. DICKSON: Thank you, Mr.

11 Chairman. The Compliance Accreditation and

12 Certification Subcommittee's work plan for

13 2013 for the Spring meeting has three items on

14 it.

15 The first of which is the

16 extension of the calculating percentage of

17 organic ingredients items, which we presented

18 the discussion document for today. We will

19 take that feedback and work as a Committee, to

20 assemble that into a concrete recommendation

21 for the next meeting.

22 We will also be exploring the
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1 issue of the use of sanitizers, as they relate

2 to 100 percent organic products, based on

3 input that we should be receiving from the

4 National Organic Program, in the near future.

5 Finally, we will be rekindling the

6 issue of retail certification. It's an issue

7 that came up back in 2007 and 2008, with the

8 previous Board. There was an earlier

9 discussion document on the sort of question of

10 the retail exemption, the extent to which

11 retailers are able to use it, what happens

12 when a retailer opts to become a certified

13 entity.

14 There are these sort of grey areas

15 of the certification policy around retail

16 stores. So, we will be dusting that

17 discussion document off and fashioning that

18 into a recommendation from the Committee for

19 the Spring meeting, as well.

20 Those are our three work plan

21 items. Thank you. 

22 MR. STONE: Thanks, Joe. Are
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1 there any questions or discussion for Joe,

2 around that work plan?

3 Okay, scrolling up, does that say

4 GMO? Yes. Zea?

5 MS. SONNABEND: Okay, the GMO ad6 hoc Subcommittee will be discussing all of the

7 comments we received about purity and GMOs,

8 and possibly, having a recommendation, or at

9 least a proposal for moving forward at the

10 Spring 2013 meeting.

11 We are going to take up the issue

12 of some of the terms used in plant breeding,

13 to clarify whether they're GMOs or not, things

14 like mutagenesis, cell fusion, micro15 encapsulation, and then on the longer term

16 work plan, I think Fall 2013 is optimistic,

17 but we're going to try to get a handle on it,

18 tracing GMOs back in the input and ingredient

19 chain.

20 MR. STONE: Any questions for Zea,

21 over members of that Committee?

22 Okay, crops? 
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1 MR. FELDMAN: Thank you, Mac. We

2 have a number of petitions that are pending

3 before the Subcommittee, polyoxine D zinc, as

4 a folier spray for fungal disease, vinasse as

5 a soil amendment, tetracycline as a petition,

6 streptomycin, we expect to receive a petition,

7 and then we have a number of aqua-culture

8 petitions, related to plant material and aqua9 culture, CO2, chlorine, micro-nutrients,

10 vitamins B1, B12 and H, lignin sulfonate, as

11 a chelating agent.

12 We also have a petition for carbon

13 monoxide, exhaust gas, add to Section 205.601

14 petition, and we will be working on plant

15 breeding issues, related to GMOS, and let's

16 see, inerts, also as a -- we'll have to take

17 a look at, you know, the policy of past and

18 coordinate with the program, on how to move

19 forward on that.

20 Finally, I guess it hasn't been

21 approved yet, but it seems as though we may be

22 working on a set of proposed guidance, or work
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1 with the program on guidance, related to the

2 biodegradable mulch, film mulch. Thank you.

3 MR. STONE: Very good, Jay and his

4 Committee. It's quite an aggressive agenda,

5 but I think with the quality of the members,

6 you can work through that. Any questions for

7 Jay?

8 MR. FELDMAN: Excuse me, I guess

9 Zea is saying we have some sunsets, which I

10 wasn't aware of, I must admit.

11 MS. BAILEY: Mac?

12 MR. FELDMAN: Okay, these are --

13 this one is --

14 MS. BAILEY: Mac, sorry. Yes,

15 Jay, we think Miles showed this to you this

16 morning. Those weren't on the Crops

17 Subcommittee list, but we know we're going to

18 have to deal with them next year.

19 So, we had added the three sunset

20 2015 materials onto the Crop Subcommittee work

21 plan, for the Fall.

22 MR. FELDMAN: Okay, so, sulfurous
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1 acid, sodium carbonate and not a -- you can

2 pronounce that last one for me, and aqueous

3 potassium silicate. Did I get that? Okay,

4 sorry, Mac, I wasn't aware of that until just

5 now.

6 MR. STONE: All right, any

7 questions or follow up for Jay or that

8 Committee?

9 Okay, next up is Handling, that is

10 Mr. Foster.

11 MR. FOSTER: Thank you. We have a

12 number of petitioned items.

13 First, on this will be gibberellic

14 acid, re-visitation of that, and its current

15 status as determination of whether or not

16 there is substantive new information, as

17 compared to the last one. We haven't made

18 that determination yet. But we'll be looking

19 at that, to see if it needs to go through.

20 We also have petitions for

21 sulfuric acid, barley beta fiber, sugar beet

22 fiber, DBD/MH, and then we're thinking of a
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1 proposal, based on this discussion document

2 around auxiliary/other ingredients.

3 Then following something we talked

4 about the last meeting, hopefully getting a

5 jump on Sunset 2015 items, gellan gum,

6 marsala, sherry and tragacanth gum. Those are

7 mostly 606, but the gellan gum will be 605

8 material.

9 So, the farther we can get on

10 those, you know, ahead of the deadline for

11 Sunset, the better. So I'd like to work

12 pretty hard to make sure we cycle through

13 those. That's it.

14 MR. STONE: Any questions for

15 John, not that I knew what all of Jay's were,

16 but what is DBD/MH, whatever it was? What was

17 that one?

18 MR. FOSTER: Really? You're going

19 to ask me that? It's a multi-syllabic word,

20 I do not have in front of me at the moment,

21 and I am not going to guess, right now.

22 MR. STONE: Okay.
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1 MR. FOSTER: If you'd like, I'll

2 be happy to tell you perhaps, after the

3 meeting.

4 MR. STONE: No.

5 MR. FOSTER: Actually, Lisa Brines

6 may be able to help. She is good, like that.

7 MR. STONE: Okay.

8 MS. BRINES: For the record, that

9 is dibromo-dimethyl-hydantoin. Thanks.

10 MR. FOSTER: Does that make you

11 feel better?

12 MR. STONE: Yes, like that helps,

13 yes. All right, you better be careful, I'll

14 end up on that Committee, if I'm not careful.

15 Livestock, Ms. Wendy.

16 MS. FULWIDER: Thank you, Mac. We

17 have quite a list of aqua-culture petitions

18 for Spring. 

19 We have tocopherol, vitamins,

20 trace minerals, lignin sulfonate and chlorine.

21 We also have a little diversion of

22 chickens. We have a methionine petition
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1 coming back, and we also may have a proposal

2 for the omnivore diets, as a follow up to the

3 discussion document. 

4 For Fall 2013, we have acidified

5 sodium chlorite and a working group update for

6 the GMOS vaccines, and I would also like to go

7 on record that at some point, I would like to

8 know when we would be able to do the animal

9 welfare guidance, because when we passed the

10 recommendations for animal welfare and animal

11 handling and transport, it was with the

12 understanding that we would have strong

13 outcome based standards to go with that.

14 And so, I would just like to know

15 at some point, you know, when the program

16 would expect we would be able to do that, and

17 we could also take that up on the Executive

18 Committee call. I don't expect an answer

19 today.

20 MR. McEVOY: Yes, we're still

21 working with the animal welfare

22 recommendations that were passed by the Board.
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1 So, we still have a lot of work to

2 do, to work on that, and what we requested

3 from the Board was to give us a little bit of

4 time to figure out how we're going to move

5 forward with that, before you developed more

6 recommendations that could potentially

7 complicate our ability to move forward on the

8 original animal welfare recommendation.

9 In addition to that, this is a

10 very lengthy, ambitious list that the

11 Livestock Committee has on their work plan. 

12 So, especially for the Spring. I think it's

13 something that we certainly can continue to

14 discuss, how the additional guidance on animal

15 welfare might fit into the work plan for the

16 Livestock Committee in the future.

17 MR. STONE: Okay, any questions,

18 Wendy? Okay, next? I'm sorry, Colehour?

19 MR. BONDERA: And I apologize if I

20 missed it, but I wanted to ask, at the bottom,

21 I think, was a, yes, GMOS vaccines, and my

22 question is, and I don't want to put anybody
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1 on the spot, but I'm just going to raise it as

2 a question, which is right now, we're in Fall

3 of 2012.

4 I personally, based on my input

5 and experience with the GMOS vaccine, am a

6 little bit concerned that there wouldn't be a

7 working group update all the way for a whole

8 other year.

9 And so, from a scheduling

10 perspective, I wonder if that could or should

11 say both Spring and Fall?

12 MR. STONE: All right, that's a

13 good point, and we'll talk about it, at the

14 Executive Committee and work with the program,

15 and see how fast that is moving with the

16 working group and certainly, an abbreviated

17 update, if nothing else, I'm sure. So, good

18 catch.

19 Materials, Ms. Jennifer.

20 MS. TAYLOR: Thank you, Mac. Our

21 work plan for the Spring and Fall will include

22 examining update petition, technical review
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1 process, define production aides, how to

2 address scientific uncertainty, which is a new

3 item that has been added to our work plan.

4 The confidential business

5 information transparency and its process, and

6 research priorities.

7 MR. STONE: Thank you, Jennifer.

8 MS. TAYLOR: Thank you.

9 MR. STONE: Any questions for

10 Jennifer? Very good. That's one more,

11 Policy, Colehour.

12 MR. BONDERA: Yes, thank you. 

13 Yes, the Policy Development Subcommittee will

14 work on reviewing and updating the manual, the

15 policy and procedure manual, doing the same

16 with the new member guide, and ideally, we

17 will have put notable energy into those, and

18 there will be something to consider at the

19 next meeting.

20 A threshold two-stage technical

21 report, which we have talked about before, but

22 it's currently targeted for Spring, as well,
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1 and then working with the Materials

2 Subcommittee, as the supporting Subcommittee,

3 but we will lead the material initiation or

4 substance annotation clean up policy and we'll

5 work on the title of that, as necessary.

6 A decisive/indecisive

7 determination of NOSB votes, and finally,

8 convening of technical Advisory Boards, the

9 policy on that. 

10 So, those are the things that we

11 have on our sort of, I guess short term agenda

12 and/or like I said, a few of them aren't

13 scheduled, but that is what I have to share. 

14 Thank you.

15 MR. STONE: And I guess with the

16 tabling of the conflict of interest, we can

17 add that back in there, as well, I guess.

18 MR. BONDERA: I think that is a

19 good point.

20 MR. STONE: Yes.

21 MR. BONDERA: We may well do that,

22 so, thank you.
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1 MR. STONE: All right, well, thank

2 you, all, for that. We all have a lot of work

3 to do.

4 So, just a few sort of remarks. 

5 I'll kind of go around and I know the program

6 may have some closing remarks, no particular

7 order, but those of you, the Committee Chairs,

8 get your final recommendations. Michelle sent

9 the new form around, so get those finalized

10 and to her, so that she can complete our work

11 for this week. It's not technically complete

12 until she gets all the paperwork.

13 Rookie mistake, on my part. Those

14 actually go to Barry, for his signature,

15 before they go to the program. 

16 So, thank you, and I hope you'll

17 join me next year, when we -- next Spring,

18 keep me on track. 

19 So, Lynn, I just wanted to follow

20 up with you, that Barry may not be on the

21 Certification Committee, but we have his phone

22 number, and we will continue with the
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1 biodiversity, because we know how to a hold of

2 him, and I'm sure he'll still be interested

3 that we do follow through on it.

4 So, I just want to say some thank

5 yous, but Michelle, do you have any

6 housekeeping or anything that you need for us

7 to know, before we part?

8 MS. ARSENAULT: I don't have

9 housekeeping, but I just wanted to kind of

10 address everyone. I didn't do that at my

11 first meeting, because I was on the job for

12 three weeks, at that time.

13 Most of you guys know I've been --

14 I'm new to the program. I've only been here

15 seven months, but I have a few impressions. 

16 This is the most incredible group of people I

17 have ever worked with. I spend an awful lot

18 of time with them on the phone, and I'm

19 incredibly impressed by how respectful and

20 thoughtful and hard working everybody is,

21 staff included.

22 If you guys have received emails
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1 from me, you may have noticed weird time

2 stamps, like late at night, weekends. I

3 wouldn't take my work home with me, if I

4 didn't really love my job.

5 But I am probably the least hard

6 working person in the office, because it's

7 definitely a team effort, and everybody works

8 really hard around the office.

9 The Board, they're amazing. I was

10 welcomed with open arms, and they're very

11 gracious and patient with all the mistakes, as

12 I fumble my way through, learning my new

13 position, and I just wanted to say thank you

14 to everyone, which I don't say often enough. 

15 So, thank you.

16 MR. STONE: Our thanks to you. 

17 Well, now, we have a couple of presentations

18 to make. Is there any comments or anybody

19 want to bring something before the Board, for

20 discussion, before we -- and we also want to

21 get a group picture, as well. 

22 So, I see Miles has a plaque
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1 there, so, if you'd like to present that.

2 MR. McEVOY: Yes, actually, I'd

3 like to also just say a big thank you to

4 Michelle. She does all the logistics and the

5 background work to support your work, and all

6 of her work supports the NOP, as well, and she

7 has just been so great to work with and just,

8 we couldn't do it without out. Thanks so

9 much, Michelle.

10 Okay, so, I have a bunch of

11 plaques to distribute, and first of all, to

12 Barry Flamm. As I said on my opening remarks

13 on Monday, Barry is an amazing individual, has

14 a lifetime of achievements before he came here

15 to the NOSB. 

16 He has contributed so much to the

17 NOSB and the organic community, and we're

18 going to miss you a lot, Barry. We just

19 really appreciate your leadership. Thank you.

20 CHAIRPERSON FLAMM: Miles and

21 staff, and Michelle, as everybody has attested

22 on the Board, that she has been terrific and
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1 you out there, it's hard to say you're out

2 there, you're in here, we're all a community

3 and a team, trying to work to further

4 organics, that we all have such a passion for.

5 So, it's been great meeting all of

6 you. Thank you.

7 MR. McEVOY: Thanks, Barry, and

8 then I have plaques for all the new Board

9 Members. You're not so new, now. This is

10 your second meeting, but we failed to give you

11 your plaques and your letters from the

12 Secretary.

13 We actually got a call this

14 Summer, kind of an angry call from the

15 Secretary's office, saying, "Why didn't the

16 Board get their letters, before they started

17 their appointment in May?"

18 So, the Secretary's office takes

19 it really seriously, your appointment, and

20 really honors your contribution to the organic

21 community and American people, by serving on

22 this Board.
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1 So, this is just a small token of

2 recognition for your service, through a

3 plaque, and hopefully, you've already received

4 your letter from the Secretary.

5 So, first of all, for Tracy Favre. 

6 I guess I could just do this all

7 together. For Andrea Sonnabend, or Zea. 

8 For Carmela Beck, thank you so

9 much for your service.

10 For Harold Austin, thank you, and

11 for Jean, for Dr. Jean Richardson. 

12 MR. STONE: Good, thank you, I

13 appreciate that. In a word that I hear most

14 often in the Certification Accreditation

15 Committee with John and Joe is awesome. It's

16 awesome to serve on this Board and many of us

17 feel like we -- as much work as it is, we

18 still benefit more than we can contribute,

19 because of the people that are in the room,

20 not just the people at this front table.

21 You know, you all are here for

22 four days and you're on the phone and the
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1 email is almost as much we are, around these

2 topics, and we couldn't do our work without

3 what you all provide to us.

4 So, there being no other business

5 to attend to, I guess I'll officially declare

6 the Fall meeting of the NOSB adjourned.

7 (Whereupon, the above-entitled

8 matter concluded at 2:19 p.m.)

9

10 

11

12

13

14

15

16

17

18

19

20

21

22
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A

AAC 81:15 87:17

abbreviate 136:22

abbreviated 193:16

ability 11:7 99:6

192:7

able 37:17 46:21

101:22 127:7

131:5 133:15

148:11 153:20

168:1 184:11

190:6 191:8,16

above-entitled

52:14 151:9

167:11 168:10

202:7

absence 84:12

absolute 80:19 96:5

133:4

absolutely 7:10

abstain 163:2,4,6

163:13,16,17

abstains 163:8

abstentions 164:3

164:13

ACA 8:5 14:22

18:17 24:20

ACAs 5:14 9:6 14:4

14:10 18:3 43:3

accept 107:11,21

114:16 115:9

125:10,14 172:16

172:21 175:3,4,18

175:19 176:19,20

177:6,16 179:14

179:22 180:2,13

180:14

acceptable 155:1

accepted 107:7

109:8 115:13

180:5,19,21

accepts 105:21

106:4

accessible 154:17

acclamation

173:22 174:3,5,8

accommodate

139:9

accompanies

115:20

accompanying

79:17 81:10

accomplished

27:13 137:2

accreditation 3:2

4:14 34:16 43:5

183:11 201:14

accredited 8:5 32:4

accrediting 5:13

8:6 10:5 11:4

16:4 43:21

achieve 27:8 77:21

137:5

achievements

199:14

acid 13:19 87:14

156:10 188:1,14

188:21

acidified 191:4

acids 156:10

acknowledge 83:2

acknowledged

84:18

acknowledges 26:3

126:11

acknowledging

100:5 121:6

Act 135:19

action 21:12 27:21

58:2 59:12 65:9

67:22 99:5 102:7

106:12 124:5

actions 62:10 64:18

79:19 81:7 85:1,4

85:6 96:14 120:15

124:18 129:22

140:1 167:2

active 124:16

137:21

activities 37:3

actual 43:9 101:10

116:18 157:5

ad 185:5

adapt 134:12

add 6:12 18:16

44:6 53:22 55:11

55:17 69:19 70:10

75:21 96:18

106:10 144:17

153:2 186:13

195:17

added 23:12 59:10

98:4 107:14

110:15 133:22

145:7 152:20

159:21 187:19

194:3

addendum 12:19

adding 16:22 17:3

70:9,22 137:15

addition 72:21

169:8 192:9

additional 18:2

29:13 94:2,6

105:22 122:2

138:13 176:2,3,3

176:22 180:6

192:14

additions 137:15

address 26:8 30:11

32:21 52:7,19

57:1 60:21 125:8

135:14 167:17

168:1 194:2

197:10

addressed 22:6

90:7 125:13

addressing 30:18

adenosine 157:18

157:21

adequate 66:12

74:4,5 139:3

141:8

adequately 125:13

137:20

Adjourn 3:23

adjourned 202:6

Administrator 2:9

2:22

admit 187:10

adopted 105:9

106:10 118:10

142:8,10 144:14

advise 18:22

Advisory 2:11

195:8

Ad-Hoc 3:17

affect 27:4

age 38:17

agencies 5:14 7:6

7:11 8:7,12 10:5

11:4 16:4 43:21

98:19 101:4

agenda 4:16 61:3

151:21 167:16

187:4 195:11

agent 186:11

agents 88:1

aggressive 187:4

ago 21:9 42:5 50:13

109:5

agree 38:4 42:22

45:7 53:22 62:7

73:17 91:11

114:20 130:18

134:6 157:2

182:17,18

agreed 21:14 26:7

agreement 26:13

27:3 68:22 117:16

agrees 161:3

agricultural 2:18

19:21 106:2

agriculture 1:1,1

20:15 49:5

agro 86:12

agronomic 138:1

ahead 52:5 54:3,4

83:7 122:18 148:6

153:9 189:10

aide 14:17 15:2,5

aides 13:5,14,18

14:5,14 194:1

air 31:9 74:19,21

air-blast 74:8

alive 113:14 138:20

alliance 21:3,10

24:6 25:1 26:18

28:15 32:16 39:15

allow 14:2 66:6,8

81:14 85:10

allowed 79:3,10

98:11 99:12

107:13 109:10

111:3 117:8,10

164:22 165:18

178:20

allowing 79:2

allows 22:11

alternative 60:21

72:7

alternatives 62:16

66:8 71:11,14,21

72:5,16 73:1

amazing 198:9

199:13

ambitious 192:10

amend 132:12

161:3

amended 144:21

amending 121:6

amendment 114:17

116:16 186:5

amendments 115:1

America 60:19

American 200:21

amino 156:10

ammunition 64:14

amount 9:3 43:11

48:4 49:2 50:2,8

126:10 164:15

amplify 118:7

AMS 1:1

analysis 81:9 103:4

Andrea 201:7

and/or 83:20 96:11

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cooperation 181:21

coordinate 186:18

copies 7:6 40:16

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cornerstones 91:20

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161:22 165:15

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correctly 144:7

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creation 83:5,8

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day 48:14 50:19

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days 40:17 41:11

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minor 10:18 16:3

minus 116:5,6

minute 151:6

172:19

minutes 47:21

168:6

minutiae 78:2

mirror 70:19

missed 174:9

192:20

mistake 196:13

mistakes 198:11

mitigate 31:1

mix 11:17 155:22

mixed 137:20

mixing 69:15

mixtures 86:10

modification

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modify 134:10

139:2

moisture 123:13

mom 104:22

moment 161:19

164:4 167:22

169:11 189:20

momentum 28:2

Monday 199:13

moniker 112:21

monitor 84:21

monoxide 186:13

monstrosity 40:13

month 104:6

months 78:19

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moratorium

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morning 4:5,8

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MOSA 37:11 39:18

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motion 53:4,8,13

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55:11,17,21 62:19

75:16,19,21 76:21

80:2,4,6 89:11,14

89:17,19 90:1

94:3,4 95:2,4,8,13

95:17,17 96:16,18

97:22 98:2,2

99:18,21,22 100:3

100:5 113:17,21

114:16 115:16

116:1,4,16 118:1

118:2,3,13 119:21

121:6,9,17 126:2

130:7 132:8,10,12

134:7 135:11

141:7 147:9

148:21 149:3,8,11

149:20 150:1,6

151:4 152:11,19

152:21,22 153:10

160:16,17 161:2,4

161:6,8,8,10,12

161:12 163:1

164:13,18,19

165:10,16 166:1

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motives 89:2

move 17:21 28:8

53:14 55:10 56:11

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mowing 142:18

MRO's 79:9

mulch 77:5 78:8

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95:19 98:10

112:21 117:7

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138:14 142:1

143:2,8,15 144:3

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multi-ingredient

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multi-syllabic

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mutagenesis

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nano 81:5 99:1

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107:11 108:6

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nano-form 117:8

nano-material

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national 1:2,4,10

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27:7 28:14,14,18

50:5,15 54:1

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75:22 107:14

110:15 117:11

144:18 145:7

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30:18 31:1,10

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nature 29:6,14

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near 120:1 184:4

nearby 31:1

necessarily 6:3

15:17 43:8 72:8

73:3 75:4 138:6

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necessary 42:17

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14:1,11,12 15:19

16:11 17:5 18:1

18:11 21:12 27:1

27:7,18 29:13

38:1,20 39:6,6

43:22,22 67:22

68:3 69:2 73:9,18

85:5,5 88:8

101:22 119:7

125:1,2,3 126:12

126:13,15 130:21

134:10 147:18

152:5 160:16

170:7 171:10,21

173:22 197:6

needed 11:13 13:10

20:13 24:15 59:7

168:17

needless 80:3

needs 12:9 40:16

44:17,21 119:11

126:14 140:20

164:18 165:11

180:9 188:19

negative 23:14

never 61:9,14

133:15 146:8

new 32:7 36:10

78:6 84:6 131:21

161:8,10 165:13

174:17 181:18

182:4 188:16

194:2,16 196:9

197:14 198:12

200:8,9

newspaper 138:4

nice 43:7

NICHOLAS 1:19

Nick 64:5 67:15

94:8 100:11

109:16 117:2

119:5 122:18

124:3 134:15

146:20 147:7

174:19 175:5

Nick's 106:11

124:2 141:19

night 48:5 77:11

104:2,17 198:2

NOC 24:22 28:21

29:3,19 30:2,9,16

31:13 32:6,12,19

nomenclature 93:5

nominate 171:11

172:14 174:21

175:11,14 176:15

177:3 179:20

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nominated 172:16

175:2,17,22 176:1

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nomination 172:5

172:11,17 173:6,8

173:13,14 174:7,7

174:18 175:3,5,18

176:13 177:6,16

178:5 179:6 180:2

180:5,7,20,21

nominations

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176:2,3,4,22

177:22 178:2

179:5,12,12,17

180:6,22 181:2,3

non 155:7

non-effective 72:18

non-nano 117:5

non-profit 47:15

non-synthetic

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159:19

non-target 31:6

NOP 1:2 5:19 6:15

9:4 12:10 18:4

22:21 28:22 29:5

29:10,18,20 30:2

31:14,19,22 32:4

32:7,11 34:1 36:4

38:21 43:22 58:20

79:16 82:12 84:13

88:20 105:20

199:6

NOP's 30:12 31:16

34:17

normal 65:16

145:8 173:3

normally 14:9

160:2

Northeast 113:13

NOSB 1:5 5:19

6:20 16:6 17:17

20:19 32:2 33:14

33:19 43:2 45:8

79:15 84:16 103:8

105:21 111:1

144:9 156:15

169:5 195:7

199:15,17 202:6

NOSB's 29:4,12

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notable 194:17

note 70:1,3

notes 30:9 31:13

notice 58:19 59:8

62:9 69:18 70:4

noticed 198:1

notification 69:16

69:22

notified 70:5

notify 70:6

not-listed 90:11

no-nano 118:5

nuances 15:9 92:10

nucleotide 3:12

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nucleotides 151:17

151:22 152:5,16

152:22 153:1,4,10

154:5 157:10,13

157:16 160:17

161:13,20 164:20

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number 20:17

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188:12 196:22

numbers 10:6

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obviously 7:2 8:14

15:13 34:20 48:3

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127:18 131:21

143:3 182:15

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occurred 61:8

occurring 37:3

OCTOBER 1:8

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office 41:17 179:17

198:6,8 200:15,18

officers 3:14

170:15

offices 43:5

official 69:22

officially 70:5

202:5

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OFPA 127:14,14

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53:10,11 54:8

55:9 57:2,9,17

66:1,2 73:6 75:14

75:20 76:3 78:18

79:6 82:20 85:15

88:6 95:16 97:9

100:11,13 114:21

119:4 122:4,7,10

122:16 124:3,21

124:22 130:15

135:8,9 144:10

145:10,11,15

147:5 150:4

151:14 153:15

154:20 155:13

161:7,11 163:9

164:7,17 165:12

166:3 170:13

171:14,18 172:10

172:22 175:8,20

176:5,11 179:4,14

180:4,18 181:1

185:3,5,22 187:12

187:22 188:3,9

189:22 190:7

192:17,18 199:10

old 48:13

OMB 98:18

omnivore 191:2
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open-ended 62:13

operations 24:12

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opportunities

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22:7,10 24:1,10

26:20 27:7 28:14

28:16,19,22 29:2

37:11,14,15 38:5

38:14,18 40:13

42:2 47:16,17

49:5,14,16 50:5

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60:3,10,18 62:8

72:22 77:13 79:4

81:21 96:22 98:11

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138:18,19 165:1,1

165:3,3,19,20,21

165:22 183:17

184:2,4 199:17

200:20

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organics 200:4

organisms 81:3

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organizations

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organized 25:5

original 129:21

135:19 136:7,14

192:8

originally 23:11

81:16

OSP 34:11 36:20

39:6,15 41:12

42:6

OSP's 42:16

ought 26:8 43:10

outcome 59:3

93:15 191:13

outliers 128:20,21

outline 79:18 139:6

outset 84:7

outside 63:22

outstanding 20:22

38:13 148:12

overall 77:12 84:13

overarching 48:1

overseen 101:6

overwhelmed 38:1

over-reaching

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oxygen 123:13

o'clock 167:9

P

package 26:19

packaging 154:6

pages 40:15 42:17

42:20 45:21

paper 40:9 44:22

45:10 173:11

paperwork 38:1

43:12 44:19 47:5

48:17 49:2 51:4

196:12

paperwork-y 50:9

paragraph 8:4

61:21

parallel 64:8 67:18

part 22:2,2 51:15

54:2 63:19,20

66:5 90:19 93:19

96:16 98:21 99:17

99:17 108:20

124:6 133:20

136:19 145:8

170:6 196:13

197:7

participate 46:5

participating 148:9

particular 23:16

28:5 98:20 99:4

108:13,15,19,22

110:18 111:6

116:16 123:20

138:8 144:13,17

144:20 145:6

178:22 196:6

parties 108:11

parting 51:10

partner 50:13

parts 22:1 144:19

pass 4:10 135:18

181:17

passed 164:4 191:9

191:22

passes 55:8 76:22

95:3 151:4 164:13

passing 88:8

164:16,18

passion 200:4

passionate 182:16

pathways 86:1,16

patient 198:11

pay 24:15

penalty 32:6,12,18

34:13

pending 62:10 63:9

106:11 186:2

people 7:1,20 18:20

19:1 24:20 43:6,7

56:20 59:13 61:16

62:15 64:16 68:21

70:1 75:18 108:12

112:20 120:21

123:8 129:18

145:13 154:1,12

169:9 171:11

173:19 182:11,16

197:16 200:21

201:19,20

people's 56:12

percent 10:18

12:17 13:4,4,8

49:16 80:18 87:14

96:5 123:5,7

132:21 133:12,16

137:16 138:7,7

184:2

percentage 3:4

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10:7 11:8 13:13

18:9 183:16

percentages 10:17

perfect 33:1

period 20:21 66:12

88:12 138:8

permitted 110:2

146:3,5

person 46:15

175:11 198:6

personal 61:2 74:5

personally 25:12

49:10 90:8 114:12

193:4

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7:15 8:8 193:10

perspectives 7:3

Pest 31:5

pesticides 24:21

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77:5 111:13,17,21

112:19 119:11,16

129:2 153:6 157:2

157:9 186:5,6,12

186:14 190:22

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127:12 152:1

153:2,11 160:9,18

161:14,21 164:21

165:18 188:12

petitioner 157:6

petitioners 112:1

petitions 58:19

61:9 186:2,8

188:20 190:17

petro 77:19

petroleum 81:15

86:19 88:5 136:16

137:7

petro-chemicals

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phase 89:10 158:16

phased 58:8

philosophy 77:12

129:11

phone 196:21

197:18 201:22

phosphate 159:22

photosynthesis

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phrase 130:20

pick 92:18
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Pine 37:13

pissed 93:15

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placed 9:4 135:3

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plaque 198:22

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plasticizers 91:16

plasticizing 88:1

plastics 77:7 82:9

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plate 169:14

platform 92:15

play 45:22 110:6

playing 36:1 60:9

please 4:4,12 17:10

17:11 40:6 41:15

52:1,18 55:14

67:13 75:16,19

113:6 119:19

148:14 151:13,19

168:14 172:1

pleased 29:7 31:19

plentiful 71:22

plenty 62:9 134:21

plow 137:13

plus 42:17 116:4

point 7:9 16:21

37:19 40:7 42:1

45:20 57:21 60:13

62:20 63:13,15

68:12 88:11 90:18

93:4 106:3 111:10

114:22 115:5,18

115:19 120:5

121:15 131:3,10

138:15 158:13

168:19 169:6,14

178:7 181:15

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pointed 14:4 27:6

pointing 43:15

pointless 39:22

points 92:17 93:3

122:15

policies 32:7

policy 3:13,22

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118:9 134:13

167:16 168:4,20

169:19 178:7,9,14

184:15 186:17

194:11,13,15

195:4,9

pollution 78:10

polymer 86:10

polymers 86:5

87:22

polyoxine 186:3

portion 36:20

170:5

pose 134:3

posed 9:18 133:10

position 120:13

156:18 159:19

171:7 172:12

176:12 177:22

178:3,20 181:7

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positions 171:11

positive 23:16 26:8

32:1 77:15 89:1,4

109:19 113:15

possible 17:22

71:13 79:2 104:15

possibly 63:6

123:11 158:4

178:16 185:8

posted 31:20 58:19

58:20

poster 51:19

postpone 104:19

post-harvest 13:6

13:15

potassium 188:3

potential 59:3 86:2

86:17 87:9

potentially 88:12

99:6 192:6

power 107:16

PowerPoint 77:8

PPE 74:5

practically 22:14

practices 47:6 59:4

59:14

precautionary 78:4

precedence 78:2

precipitating

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predict 59:18

predictable 104:22

preferable 104:4,5

prepare 47:19 59:2

59:2 77:11

prepared 154:6

prescription

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present 1:13 2:7

4:8 5:1 15:3,4,20

77:2 92:14 199:1

presentation 33:5

43:16 74:2,2 90:7

presentations

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presented 5:11

62:19 74:18 168:3

183:17

presenting 16:12

19:15

presiding 1:12

presumably 142:11

presumption 127:5

143:4,17

pretty 42:8,13

62:21 67:1,2,7

189:12

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preventable 105:1

previous 62:2

84:16 140:15

184:8

previously 31:14

85:3 116:20

118:10 132:16

primarily 152:18

principle 78:4

142:14 143:5

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principles 28:22

78:11

priorities 88:16

194:6

prioritized 143:4

priority 88:17

104:16 134:1,4

privileged 93:19

privy 61:6

probably 42:11

68:16 73:13 75:10

108:12 126:8

170:11 198:5

problem 5:11

21:16 60:22 69:8

91:18 98:21 99:22

100:17,20 102:18

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problems 40:3

141:21 142:21,22

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procedure 132:12

173:3 194:15

procedures 5:14

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54:11 94:7 95:8

109:22 110:4

119:12 121:11

132:18 147:6,8

150:8 151:19

155:16 162:22

166:3 171:6

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process 23:6 40:17

49:19 56:10,14,16

56:21 57:6,11

58:16,18 59:6,20

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82:17 91:3,14,15

92:13,20 93:10,10

99:9 101:13 103:2

105:8 106:2,5

109:13 124:12

139:19 140:16

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153:22 154:1,3,10

154:12 156:1,21

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105:12 106:4

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progress 4:20 20:1

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prohibited 54:1

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project 134:4

promising 71:12

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pronounce 87:18

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129:18 132:11

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52:8,20,22 53:4

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proposed 23:19

69:19 70:16 88:9

88:11 95:12

102:15 130:7

140:7 142:9 168:2

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Providence 1:11

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106:8 108:2

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pursue 78:20

put 8:4 10:21 17:6

17:7,8 36:19

42:18,21 51:20

52:3,3 65:1 68:20

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NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 

1323 RHODE ISLAND AVE., N.W. 

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 

C E R T I F I C A T E

This is to certify that the foregoing transcript 

In the matter of: 

Before: 

Date: 

Place: 

was duly recorded and accurately transcribed under 

my direction; further, that said transcript is a 

true and accurate record of the proceedings. 

 

 ----------------------- Court Reporter 

229

Meeting of the National

Organic Standards Board

USDA

10-18-12

Providence, Rhode Island