NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP 

 

For NOSB Meeting: _____________________ Substance: _Tetracycline_

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

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

 

2. Essential & Availability Criteria Yes  No √ N/A 

3. Compatibility & Consistency Yes No √ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A √ 

B. Substance fails criteria? 

Criteria category: __2 and 3

 

____ 

Comments: Only marginally passes 

Criteria category #1 

C. Proposed Annotation: _Tetracycline- For fireblight control only with expiration 

date of 10/21/2012 

 

Basis for annotation: 

 

To meet criteria above: ____ Criteria: _______________ 

 

Other regulatory criteria: ____ Citation:_______________

D. Final Board Action & Vote (State Actual Motion): Add Tetracycline –For use only for fireblight control until 10/21/2012 as listed 

on the National List §205.601(i) 

 

Motion: _D.Giacomini Second:T.Miedema_ Yes: 13 No: 0 Abstain: __1__ Absent: 

 

 1 .

Provide a summary narrative here or attach a more complete narrative, and attach the original committee recommendation

that includes the evaluation criteria checklist: 

Two forms of tetracycline are registered by the EPA for use in apples and pears for fireblight control. Previously, only one form was 

specifically listed on the NOP National List of allowed synthetic materials in organic crop production. This recommendation changes 

the listing to generic tetracycline and places an expiration date of 10/21/2012 on the use of all forms. 

 1—substance voted to be added as “allowed” on National List to § 205.601(i)_ with Annotation (if any): For firebligh control only 

with expiration date of 10/21/2012 

2—substance to be added to “prohibited” paragraph of National List to § 205.______ Describe why a prohibited substance: 

_____________________________________________________ ___________________________________

__ ____

 _

 

___ 

3—substance was rejected by vote for amending National List to § 205. ______ Describe why material was rejected: _____ _ 

___________________________________________________ __ 

4-substance was recommended to be deferred § 205. ______

 

 Describe why deferred; if any follow-up is needed. If follow-up needed, 

who conducts follow-up ________________________________ ____________________________________ 

Agricultural Nonagricultural Crops X 

Synthetic X Not synthetic Livestock 

Allowed X 1Prohibited2

Handling 

No restriction Deferred4 Rejected3

E. Approved by NOSB Chair to transmit to NOP 

 Rigoberto Delgado . 

Chair Date

 11/19/2008 .

F. NOP Action: Include in FR to amend National List: 

 Return to NOSB Reason: ____________________________________________________________________ 

 

_____________________________________ _________________________ 

 Date 
Decision Sheets

December 2006

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: __November 2008____ Substance: Tetracycline (oxytetracycline hydrochloride) 

Committee: Crops √ Livestock  Handling  Petition is for:_AddingTetracycline (oxyteracycline hydrochloride), 

for fire-blight control only on the National List § 205.601(i).

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

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

 

2. Essential & Availability Criteria Yes  No √ N/A 

3. Compatibility & Consistency Yes  No √ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No  N/A  

B. Substance Fails Criteria Category: __2 & 3___ Comments: Material only marginally satisfies Criteria #1. Fails Criteria #2 

since other organically compliant disease control options exist. Pear and apple growers exporting to Europe, where antibiotics are 

not allowed, are already achieving some measure of fireblight control without the material. It fails Criteria #3 on compatibility with 

public perception that antibiotics are not used in organic production, and on consistency within the NOP regulations that do not 

allow antibiotic use in any other section of the Rule. The committee views this incompatibility and inconsistency with organic farming 

principles as potentially damaging to the reputation of the organic label overall. Considering the intense on-going public comment 

that the committee has been receiving on the negative public health impacts of these materials, the committee anticipates that a 

petition will be filed for the removal of tetracycline and streptomycin from the National List before their sunset date of October 2012. 

Adding a new form of tetracycline to the list at this time would be counterproductive. 

C. Proposed Annotation (if any): _____________________________________________________________________________

________________________________________________________________________________________________________ 

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:______________________ 

D. Recommended Committee Action & Vote (State Actual Motion): Adding Tetracycline (oxyteracycline hydrochloride), for fireblight control only on the National List § 205.601(i)

Motion by: J.Moyer__ Seconded: T.Ellor__ Yes: _0__ No: _6__ Absent: 0___ Abstain: _0__ 

 

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) ______________________ 

________________________________________________________________________________________________________ 

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _________________________ 

________________________________________________________________________________________________________ 

Describe why a prohibited substance:__________________________________________________________________________ 

________________________________________________________________________________________________________ 

 

3) Substance was rejected by vote for amending National List to § 205.601(i)(10)Describe why material was rejected: Material 

fails evaluation criteria 2 and 3 (See comments listed above in section B. __________ 

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up _____________________________________________________________________

Crops 

___________________________

X Agricultural Allowed1

 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic X Rejected X 3

No restriction Commercially UnAvailable as Organic1

 Deferred4 

E. Approved by Committee Chair to transmit to NOSB:

___Gerald Davis__________ 08/20/2008 

 Committee Chair Date
Decision Sheets

December 2006

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance – Tetracycline (oxytetracycline HCl) 

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal? 

[§205.600 b.2]

X 

TR: Line 163-164

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X 

TR: Line 174-175

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X 

TR: Line 188-191

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

X 

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X 

TR: Line 200-202

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]X X 

No: TR Line 210-212 (Based on original EPA estimation)

Yes: Potential detrimental effects on soil bacteria. Short term 

effects on pond sediment microorganisms from veterinary 

tetracycline mentioned in TR. Antibiotic resistance genes 

found in soil bacteria provide a gene pool that has been shown 

to be potentially transferable to human pathogens. ‘Sampling 

the Antibiotic Resistome’ by V. M. D’Costa et al. Science 20 

January 2006 Vol. 311 No. 5759 pp. 374-377 and 

‘Mechanisms for Resistance in Soil’ by Stuart B. Levy, et al.; 

Science 28 April 2006; Vol. 312, No. 5773 pg. 529. 

‘Antibiotic use for Plant Disease Management in the United 

States’ Patricia S. McManus and Virginia O. Stockwell in 

Plant Health Progress 27 March 2001 

http://apsnet.org/education/feature/antibiotic/top.htm. 

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

X X 

TR: Line 217-223 Potential detrimental effects expected to be 

mitigated with proper use in orchard system

See also Question #6

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2]

X X 

TR Line232-256 Toxicological studies on rodents show no 

adverse effects, except to a limited extent at extremely high 

dosages. Human medicinal use side effects and allergic 

reactions do occur.

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

X 

TR: Line 261-270

Degradation half-life varies from 30 days (freshwater) to 10 

weeks in pond sediments. Adsorbed and inactivated in dry 

soils.

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4]

X X 

Chronic dietary intake and occupational exposure risks are 

considered to be negligible by EPA. EPA pesticide label 

regulation on minimizing allergic reaction risks concerning 

spray application workers. (TR: Line 275-293)

Recently published scientific commentaries address concern 

with antibiotic resistance gene transfer from bacteria species 

in the agro-ecosystem to human pathogens, resulting in 

potential human health issues due to loss of efficacy in 

medicinal use antibiotics. ‘Sampling the Antibiotic Resistome’ 
Decision Sheets

December 2006

by V. M. D’Costa et al. Science 20 January 2006 Vol. 311 No. 

5759 pp. 374-377 and ‘Mechanisms for Resistance in Soil’ by 

Stuart B. Levy, et al.; Science 28 April 2006; Vol. 312, No. 

5773 pg. 529. ‘Antibiotic use for Plant Disease Management 

in the United States’ Patricia S. McManus and Virginia O. 

Stockwell in Plant Health Progress 27 March 2001 

http://apsnet.org/education/feature/antibiotic/top.htm.

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X 

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

X 

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
Decision Sheets

December 2006

Category 2. Is the Substance Essential for Organic Production? Substance - Tetracycline (oxytetracycline HCl)

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

X X 

Parent material formed by natural fermentation process. 

Material as formulated may or may not have undergone 

chemical change during manufacture. 

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

X X See above- question #1. Tacit acknowledgement of chemical 

change during manufacture, as material is petitioned as a 

synthetic substance to be added to the National List.

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X X 

See above- question #1

4. Is there a natural source of the 

substance? [§205.600 b.1] X

5. Is there an organic substitute? 

[§205.600 b.1] X

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

 

X 

 

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

X X 

Available natural biological control materials are not adequate 

to control the serious damage caused by the fireblight 

organism. Effective natural products containing Bacillus 

subtilis, B. pumilis and others available for stone fruit 

(nectarine and peach) disease control.

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

X 

9. Is there any alternative 

substances? [§6518 m.6]

 

X 

Peracetic acid for fireblight control is partially effective.

Some Washington state pear growers (for European export) 

achieving some measure of fireblight control without 

tetracycline, which is not allowed by Euro. Organic rules.

Hydrated lime is used in stone fruit for disease control.

Copper fungicides only marginally effective due to 

phytotoxic properties on crop leaves and fruit. (TAP Line 314-

330)

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X 

Apple and pear varieties exist with limited to some resistance 

against fireblight. Careful soil site selection (well drained) is

useful in disease control. (TAP Line 342-343) 1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
Decision Sheets

December 2006

Category 3. Is the substance compatible with organic production practices? Substance - Tetracycline 

(oxytetracycline HCl)

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? [§205.600 

b.2]

 

X 

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X 

Antibiotics of this type are disallowed for any other uses in

the USDA/NOP regulations. Marketing claims of organic 

products of many kinds state that no antibiotics are used.

Public perception to a high degree expects that no antibiotics 

are used. 

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

X 

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3]

X 

5. Is the primary use as a 

preservative? [§205.600 b.4]

 

X

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4]

X 

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

a. copper and sulfur compounds; X 

b. toxins derived from bacteria; X

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals?

X 

d. livestock parasiticides and 

medicines? X 

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners?

X 

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
Decision Sheets

December 2006

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance - ______________________________________

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown)

1. Is the comparative description

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling?

 

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling? 

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quality to fulfill an essential function 

in a system of organic handling? 

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate

quantity to fulfill an essential 

function in a system of organic 

handling?

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following:

a. Regions of production (including 

factors such as climate and number of 

regions);

b. Number of suppliers and amount 

produced;

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

e. Are there other issues which may 

present a challenge to a consistent 

supply? 
National Organic Standards Board (NOSB)

Tetracycline Hydrochloride Vote 

Excerpts from

November 19, 2008 Transcripts 

1st

2

Vote, Motion to List Failed: pp.129 – 148

nd

3

Vote, Motion to Reconsider, Passed: pp 191 - 194

rd Vote, Motion to List with October 2012 Expiration date on 

all forms of Tetracycline, Passed: pp 195 - 212

MR. DAVIS: The next one would be materials. The first one on 

the list would be tetracycline, tetracycline hydrochloride to 

be specific. The committee met this morning and discussed 

the public comment that was received and the discussions 

yesterday on the relative merits of leaving the petition as 

is for - as a petition for adding tetracycline - 

oxytetracycline hydrochloride specifically, for fire blight 

control only on the national lands to apply 601I leaving it 

as it stands versus the idea of changing it to amend the 

annotation of the existing material on the list, which is 

tetracycline - oxytetracycline calcium. This is a different 

material, different CAS number, we felt it would be

problematic to go about it that way to list - to present it 
as a - just an addendum change - an annotations change, 

excuse me - and prefer to just let it go forward as is.

 MR. DELGADO: So you want to state the motion?

 MR. DAVIS: The motion would be to - 

 MR. DELGADO: You are moving to add? You are 

going with the addition of this material, correct?

 MR. DAVIS: Right. The motion is to add this 

material to the national list as stated on the 

recommendation. 

 MR. MOYER: I'll second it. 

 MR. DELGADO: Seconded. It is moved and seconded 

that - you have a question? State the question? 

 Let me state the question. I was confused by the 

indication there. It is moved and seconded to add 

tetracycline - oxytetracycline hydrochloride for fire blight 

control only onto the national list, Section 205.601(I).

 Discussion? Joe?

 MR. SMILLIE: Sorry, but I'm a little bit confused 

on this in two areas. The first area is, and correct me 

where I'm wrong, Jerry and Jeff, but the first area is, if we 

added it as an annotation which you are not going to do, but 

if we had done that then it would provide a level playing 
field for the petitioner but would not extend the use of 

tetracycline in general; it would sunset at the same time as 

the current material is going to sunset; is that correct?

 MR. DAVIS: That is correct.

 MR. SMILLIE: But you decided not to do that? You 

have decided not to change the annotation?

 MR. DAVIS: We went with the original petition 

which was to add this material?

 MR. GIACOMINI: Could we check with the program on 

that issue? It seems to me a reevaluation of this substance 

and this listing by the board could reset that clock. Could 

we please ask the program for clarification on that?

 MR. DELGADO: Certainly -- comment on that for us. 

If we change the annotation would it extend in anyway the 

sunset provisions on that? Of the calcium materials in this 

case?

 MR. GIACOMINI: If it's a reevaluation of an 

existing list to change an annotation, is that considered a 

review by this committee of this substance? And if that 

annotation is changed in the Federal Register would that 

reset the clock?

 MR. MATTHEWS: We don't believe it would. 
 MR. DELGADO: The program does not believe that 

would be affected. So Joe, with that statement, is that

clarified? 

 MR. SMILLIE: Rather than get caught up in 

parliamentary language, here is my intent, and sorry, maybe 

I'm not phrasing it properly. My intent is to offer a level 

playing field to the petitioner. That doesn't extend to the 

use of tetracycline. So my vote would be, I want to see the 

petitioner get a level playing field, but if that means 

extending the use of tetracycline I would vote no. 

 So I want to vote my intention, which is to give 

the petitioner a level playing field with a competitor who 

uses the same product currently allowed under the regulation, 

but if that's best accomplished by adding this material, then 

I could be comfortable with that. But if by adding the 

material we move the sunsetting of that tetracycline farther 

along then I wouldn't be comfortable. 

 Am I explaining myself correct?

 MR. DELGADO: Hugh. 

 MR. KARREMAN: I understand what you're saying 

totally, Joe, and as to the rationale, I feel the same way. 

I think that we need to look at this material in the way 
we're looking at it, and it's tetracycline is the active 

compound. The salt of this particular tetracycline is kind 

of to level the playing field, but the active is 

tetracycline. So if it doesn't reset the clock - and it 

shouldn't, it should not, because tetracycline is already on 

there, and we are just kind of saying, well, this color of 

tetracycline is -- not to get any color, sorry, sorry -- but 

you know that this is just embellishing what is already 

there, but the main top one is going to go away, whenever it 

does. I agree with that and I hope it is that way, if that 

is the motion; I want to hear that for sure. 

 MR. DELGADO: Dan and Jeff.

 MR. GIACOMINI: I agree with Joe and Hugh, and I 

think that as Gerry described, whether it was problematic 

depends on how the annotation is attacked. If the annotation 

is attacked by adding this substance to the list that is 

already there, of adding a second item in the parentheses, 

you have a CAS number problem, and you have other problems. 

 If the annotation is attacked by deleting that in 

the parentheses, I don't think you have that problem. I 

think you accomplish the same thing. I think you level the 

playing field, and I am - maybe I'm being a little 
schizophrenic, but I have a problem adding a separate 

listing. I'm not comfortable adding another item in the 

annotation. I'm very comfortable deleting that between the 

parentheses, and at the same time I have no problem at all if 

at the next meeting we have a petition to remove 

tetracycline, and I vote for that to happen. 

 I have no contradictions in all those things. 

 MR. DELGADO: Joe. 

 MR. MOYER: Yes, two points. One is, I believe at 

the last meeting when this was discussed, the program did 

tell us that it reset the clock. So I do think I'd want a 

clarification on that before we vote. 

 The second point is, I think removing bracketed 

information on annotations is a little bit of a risky 

slippery slope. There are reasons that many of these 

annotations were put on, and different formulations of 

different material react differently in the environment, and 

within the context within which they are being applied. 

 And I just think we have to be careful as we look 

at all these materials that we don't just look at base 

ingredients and assume that everything else that is being 

done there is okay moving forward. 
 MR. DELGADO: Bea followed by Hugh.

 MS. JAMES: I would agree with what Jeff just 

said, and because it was clear yesterday during comment that 

it was a separate CAS number that it should be looked at 

separately.

 MR. DELGADO: Hugh?

 MR. KARREMAN: I'm not an agronomist, obviously, 

but I would honestly, I understand what you are saying, Jeff, 

but it's tetracycline; it's not the hydrochloride. And it's 

a different CAS number. It could reset the clock. I would 

rather just see that parenthesis taken out of there. And 

it's tetracycline, whoever set it, let's kill it soon, but 

let's not reset clocks and all that if we don't have to.

 MR. DELGADO: Barbara?

 DR. ROBINSON: Well, I think to your point, Jeff, 

on the annotation, I think the point is that the annotation 

is for the purpose of the tetracycline, and the purpose is 

for fire blight control only. That's really what you are 

annotating here. It's tetracycline for fire blight control; 

that's what you want. 

 MR. DELGADO: It's actually not the annotation. 

Just for clarification, it's actually the title - 
 DR. ROBINSON: The original annotation says, 

tetracycline in parenthesis, oxytetracycline calcium complex. 

What you want - what you'd be doing is just removing that 

parenthetical, oxytetracycline calcium complex. So you'd be 

left with tetracycline for fire blight control only, which 

would allow the forms of tetracycline, which is what the 

petitioner has asked for: tetracycline. 

 MR. MOYER: But it does have a separate CAS 

number, and is for all intents and purposes.

 DR. ROBINSON: Right, but EPA says that these 

forms are all functionally equivalent for fire blight 

control. That's what the petitioners said, so that's what 

we'd be allowing under the same clock.

 MR. MOYER: And the second question was whether 

the clock will be reset as you stated, Jeff, and the question 

again is no - the answer is no. 

 DR. ROBINSON: And that's what we would put in the 

rule. That the clock does not change. 

 MR. DELGADO: The clock does not change. Bea 

followed by Jennifer and then Jerry. 

 MS. JAMES: So my question for Jerry then is, by 

creating this level playing field are we then making it so 
that there are two forms of tetracycline that are being used?

 MR. DELGADO: Jerry?

 MR. DAVIS: Effectively I think the petitioner 

stated it accurately when they said that there would be two 

forms of tetracycline, but the overall use pattern of 

tetracycline would not increase. There would just be a 

substitutionary effect at the whim of the marketplace on 

which one they wanted to choose.

 MR. DELGADO: Jennifer. 

 MS. HALL: Just for clarification, the -- is not 

here, did - oh, he said he was leaving, sorry - he did assess 

this and say yesterday that he did not intend to reset the 

clock; that the standing sense, that was fine.

 MR. DELGADO: Steve. 

 MR. DeMURI: Jerry, there are other members that 

are experts in this area, are there other forms of 

tetracycline that would fall into this category later on?

 MR. DELGADO: Jerry. 

 MR. DAVIS: I can't state that for sure. I don't 

remember from the EPA documents that we went over whether 

there are additional forms. You'd have to ask that maybe of 

the petitioner if you wanted to know that. There's none on 
the marketplace that I know, but I don't know if there are 

technical forms that could arise. 

 MR. DELGADO: Could the petitioner please address 

that question?

 MR. RICHARDSON: Paul Richardson with AgroSource. 

And there are currently only the oxytetracycline base 

material, oxytetracycline hydrochloride and oxytetracycline 

calcium registered with EPA. And those are the only forms 

that I would be aware of that would potentially be used in 

agriculture, and even the base is not used in agriculture, 

because its form is really just the hydrochloride or the 

calcium.

 MR. DELGADO: Tina.

 MS. ELLOR: And that was basically question and 

what came up in our discussions is that we didn't know how 

many forms there were, and if you took the parenthetical, you 

know -- we didn't know what kind of door we'd be opening, and 

really felt like we had to review all of those individually 

for their effects on the environment. 

 MR. DELGADO: Bea. 

 MR. DAVIS: In reading the EPA documentation they 

do not delineate the different forms of tetracycline as 
having any different environmental or human health effects. 

 MR. DELGADO: Bea?

 MS. JAMES: My question is, why do we want to 

create a level playing field for a material that we don't 

think should be on the list anyway - some of us?

 MR. DELGADO: Joe. 

 MR. SMILLIE: Because it's just fair. 

 MS. JAMES: In one aspect.

 MR. DELGADO: Hugh. 

 MR. KARREMAN: Bea, I guess the intent, roughly 

stated by a few of us here, is to get rid of tetracycline. 

His petition and his public comment basically said, he's 

squeezed out of market price because - it's to be just and 

fair. That's why I agree. And I'm not even in favor of this 

material, but I agree with that rationale. 

 MS. JAMES: So is our duty to be just and fair to 

the manufacturer or to the organic principles?

 MR. KARREMAN: Well, right now, an organic 

producer, whatever the crop it's used on will be buying it 

from the other guy. It's not like they are not going to use 

it. He's just asking that he has fair competition in the 

marketplace. It's not like it's not allowed right now in 
organic production; it is. 

 MR. DELGADO: Barry. 

 MR. FLAMM: One of the things we discussed at 

length in committee was the intent to remove them - these 

substances through the sunset process. And in that 

connection we discussed what kind of message approving any 

new form. 

 And the petition we had before us is what we 

addressed, and addressed carefully the second go-round. We 

did it at the last meeting, and then pulled the vote at the 

last minute, and we are sort of going around the same block 

again. 

 I'm concerned if we change the committee's 

deliberation on this. 

 MR. DELGADO: Barbara. 

 DR. ROBINSON: Mr. Chairman, we just consulted 

with our attorney, and it will change the clock. It will 

change the clock. It will change the clock. Your annotation 

change does change the clock.

 MR. MATTHEWS: Yes, it's considered - even by 

removing the annotation it's looked at as if you have 

reconsidered the material and therefore the clock resets. 
 DR. ROBINSON: I apologize. 

 MR. DELGADO: Dan.

 MR. GIACOMINI: If we are held to the standard of 

only reevaluating new material at sunset, and I understand 

that everybody is allowed to make their vote - I'm not aware 

of a lot of new information that has come to light or will or 

likely will come to light. We know what this does, and we 

would like to get it off. The way to get it off is a 

petition to remove. It's still a matter of what is fair and 

just and equitable. We're not adding anything new. 

 I question whether we are affecting the rate - 

the point in time when we can remove it by the fact that we 

are changing - resetting the clock and redoing sunset. I 

still think it's the right thing to do. I still hope 

somebody submits a petition to remove it. 

 MR. DELGADO: Hugh. 

 MR. KARREMAN: When is the sunset - when will the 

current listing go?

 MR. DELGADO: Jeff. 

 MR. MOYER: Just to follow up on what Barry said, 

I think as a board we have to be careful about the message we 

send to the community when we reevaluate this, and that is 
what we are doing is reevaluating it and extending the life 

expectancy of this material for another two years, we have to 

be careful about that. And that did come up in our 

deliberations in our committee - five more years. Three from 

the previous. 

 MR. DELGADO: Any other questions or comments?

 The motion stands then as it is? Okay, I'll put 

the motion, and the question is on the motion to list 

tetracycline - oxytetracycline hydrochloride for fire blight 

control only on the national list, Section 205.601. 

 And we'll start taking the vote with Bea?

 MS. JAMES: No. 

 MR. DELGADO: Jerry. 

 MR. DAVIS: No. 

 MR. DELGADO: Tina. 

 MS. ELLOR: No. 

 MR. DELGADO: Tracy. 

 MS. MIEDEMA: Yes. 

 MR. DELGADO: Joe. 

 MR. SMILLIE: No. 

 MR. DELGADO: Barry. 

 MR. FLAMM: No. 
 MR. DELGADO: Hugh. 

 MR. KARREMAN: No. 

 MR. DELGADO: Kevin. 

 MR. ENGELBERT: No. 

 MR. DELGADO: Jennifer.

 MS. HALL: No. 

 MR. DELGADO: Steve.

 MR. DeMURI: No. 

 MR. DELGADO: Julie. 

 MS. WEISMAN: No. 

 MR. DELGADO: Dan. 

 MR. GIACOMINI: No.

 MR. DELGADO: Jeff. 

 MR. MOYER: No. 

 MR. DELGADO: And the chair votes no. 

 MR. MOYER: Mr. Chairman, we have one yes, 13 

noes, and one absent. 

 MR. DELGADO: The noes have it, and the motion to 

list tetracycline oxytetracycline hydrochloride in Section 

205.601(I) of the list is lost. 

 Let's proceed with the next. 

MR. DELGADO: Let's move on to our next topic. But before 
that, it is my understanding that the chair of the Materials 

Committee would like to make a special motion; is that the 

case?

 MR. GIACOMINI: Mr. Chairman, I move to reconsider 

the vote on the listing of tetracycline.

 MR. SMILLIE: Second. 

 MR. DELGADO: It is moved and seconded to 

reconsider the vote on tetracycline. 

 MR. FLAMM: Discussion? Mr. Chairman, would you 

please explain the reasoning for that?

 MR. GIACOMINI: We have new information regarding 

possible action on this petition that we think is worth 

considering at this time. 

 MR. DELGADO: Can we have background about the new 

information? And I would request the program to address 

that.

 MR. GIACOMINI: Do we want to address that now or 

do we want to do that at the point in time that that further 

motion is made, the motion to reconsider?

 MR. DELGADO: To reconsider, we'll do that and 

then we'll go on to vote that if the motion passes. 

 Any questions? Are we ready for the question on 
the motion? The question is on the motion to reconsider 

tetracycline. 

 This is the vote that we just took. Is there any 

doubt on the part of the board as to what we are doing? 

 Okay, and the question is on the motion to 

reconsider the vote on tetracycline.

 And I'll start the vote with Joe. 

 MR. SMILLIE: Yes. 

 MR. DELGADO: Barry. 

 MR. FLAMM: We're not going to have an explanation 

of why we are doing that?

 (Simultaneous speakers.)

 MR. DELGADO: Once again we are going through the 

motion to reconsider evidence on tetracycline. 

 Once we have approved the motion, if it is 

approved, then we will continue on to reconsider the motion 

and do the vote again. That's where we are. 

 It is the understanding - 

 (Simultaneous speakers.)

 MR. FLAMM: Abstain. 

 MR. DELGADO: We'll continue then with Hugh. 

 MR. KARREMAN: Yes. 
 MR. DELGADO: Kevin. 

 MR. ENGELBERT: No. 

 MR. DELGADO: Jennifer. 

 MS. HALL: Yes. 

 MR. DELGADO: Steve. 

 MR. DeMURI: Yes. 

 MR. DELGADO: Julie. 

 MS. WEISMAN: Yes. 

 MR. DELGADO: Dan. 

 MR. GIACOMINI: Yes.

 MR. DELGADO: Jeff. 

 MR. MOYER: Yes. 

 MR. DELGADO: Bea. 

 MS. JAMES: Abstain. 

 MR. DELGADO: Jerry

 MR. DAVIS: Yes. 

 MR. DELGADO: Tina. 

 MS. ELLOR: Yes. 

 MR. DELGADO: Tracy. 

 MS. MIEDEMA: Yes. 

 MR. DELGADO: And the chair votes yes. 

 MR. MOYER: Okay, Mr. Chairman, we have 11 yeses 
and one absent and two abstentions. 

 MR. DELGADO: The yeses have it, and the motion is 

agreed to. 

 MR. GIACOMINI: Mr. Chairman. 

 MR. DELGADO: Let us just confirm that we have the 

right number here. 

 The yeses have it, and the motion is agreed to. 

 And we'll start immediately with a motion, 

tetracycline if that's the case. Are you going to move that?

 MR. GIACOMINI: I move to amend the motion on the 

listing of tetracycline to read, to change the annotation - 

the listing and annotation of tetracycline to read: 

tetracycline for use only in organic crop production for fire 

blight control until October 21st

 MR. DELGADO: Is there a second?

, 2012. 

 MS. MIEDEMA: Second. 

 MR. DELGADO: It is moved and seconded to - and 

let me make sure that I state this right - remove the 

annotation and replacing that with, for use - tetracycline 

for use only for fire blight control until October 21st

 Is that correct?

, 

2012, as listed on the national list, Section 205.601(I).
 MR. GIACOMINI: Yes. 

 MR. DELGADO: But we are replacing that with the 

annotation that it can be used only until October 21st

 Any other questions. Barry. 

, 2001. 

You have it there? Great. 

 MR. FLAMM: Does that mean that all forms of 

tetracycline? And that changes the current list? And how do 

we do that?

 MR. DELGADO: Good question, dan. 

 MR. GIACOMINI: This motion to change the 

annotation does a couple of different things, how many 

depends on how you add them up. The first thing that it does 

is, it removes the qualifier of what type of tetracycline can 

be used at this time. 

 The next thing that it does is, it sets an 

expiration date for the use of tetracycline in crop 

production for fire blight control. 

 The implication of that is that it pulls 

tetracycline out of the normal sunset process, and - i.e. 

think Methionine - it is now an expiration date for the use 

of tetracycline for this use. It is not a sunset item. And 

in order for it to continue use after that date it would have 
to be re-petitioned, as we do with methionine, as we did at 

the last meeting. 

 Those are the things that this amendment would 

accomplish.

 MR. FLAMM: But just for the record and for 

clarification, what we're voting on is all forms of 

tetracycline that will have the expiration date as listed; 

therefore, not requiring the normal sunset process.

 MR. GIACOMINI: It moves it out of the normal 

sunset.

 MR. FLAMM: Okay, so our vote would be based on 

those conditions. 

 MR. GIACOMINI: The first vote is the amendment to 

change the original motion. If this fails we would then need 

to revote on the original motion because we are looking to 

reconsider it. So the first thing is whether we are agreeing 

to change the original motion. The next vote that will be 

required is to vote on the new listing motion. 

 MR. FLAMM: But I think we ought to be what's in 

the record, what we are intending to do, so that it doesn't 

get changed down the road somehow. 

 MR. DELGADO: Okay, so with the comments of the 
materials chair, the intent is clear. 

 Would you like to add another - just as a 

comment. Kevin?

 Can you repeat that, we are having problems 

hearing you?

 MR. ENGELBERT: I'm just concerned about the 

process that we're going through putting it back on the table 

after it has already been voted down. 

 MR. DELGADO: Hugh followed by Judy. 

 MR. KARREMAN: Let me ask this. If we are opening 

this back up, can we - I apologize for my scratchy voice 

today - okay, we put the date whatever it is something 2012, 

I mean technically right now could we make it 2010? 

 MR. GIACOMINI: The date - we could make it any 

date we want. The date chosen is the expiration date of the 

current sunset. 

 MR. KARREMAN: So in other words if this is alive 

and well right now it may not be shortly. If I were to make 

an amendment to make it die in 2009. I mean is that possible 

to do at this time if we are opening this back up? I just 

wanted to know that. 

 MR. DELGADO: Bea. 
 MS. JAMES: I support Hugh's suggestion.

 MR. DELGADO: You haven't made an amendment, have 

you? 

 MR. KARREMAN: I just wanted to know if it's 

possible. I did not make an amendment. I just wanted to 

know if it was possible. 

 MR. DELGADO: Hugh. 

 MR. KARREMAN: All right, I will make an 

amendment. I will move that tetracycline's expiration date 

be changed from what's showing on the screen, if you could 

show that please, Valerie, from October 21st, 2012, to 

December 31st

 MR. DELGADO: Dan?

, 2009.

 MR. GIACOMINI: I don't oppose it, but I think 

it's worth a board vote on that, so I'll say no. 

 MR. DELGADO: Okay. So we have a friendly 

amendment. Is there a second?

 MS. JAMES: I second it. 

 MR. DELGADO: It has been moved and seconded to 

amend the motion by striking out the date of 10/21/2012 by 

December 31st

 Discussion? Jerry?

, 2009.
 MR. DAVIS: I can appreciate the board members who 

really would like to see this material be off the list. I do 

not think that is fair to the pear growers to - unless they 

supposedly should have been, could have been, maybe found 

some other alternatives by now but they haven't. They are in 

their infancy in the alternate control measures, and they 

could really use the extra time to get it done. 

 MR. DELGADO: The program, followed by Joe.

 DR. ROBINSON: Well, now you are going to veer off 

into some other areas, once you do this. Now you - a couple 

of things. Number one, if you do this, and you are 

successful just as a practical matter you are pushing the 

program on the rulemaking side of things, 2009. 

 And number two, the original tetracycline was on 

until 2012, even if we were successful in getting the rule 

out, first of all we'd have to answer to OGC as to now why we 

are doing that, and then you are liable to get a lot of push 

back in public comment for why you are interfering with an 

existing annotation there. It looks a little arbitrary and 

capricious on that side. Whereas before you were just taking 

advantage of an opportunity to do what - to eliminate a 

synthetic that you don't what on the list. 
 So - yes. 

 MR. DELGADO: Joe followed by Hugh.

 MR. SMILLIE: I agree with what Gerry and Barbara 

have got to say. I think that the key, though, that's going 

too far, it's not being fair. Think about the methionine, 

that's an example, I think about this case. And we are going 

to act judiciously. We all agree we want it to go, but I 

don't think we should use this to push back. We've got 2012 

already. We are sticking with 2012. We're just leveling the 

playing field. But then we get a drop-dead date, which is 

better than where we were before.

 MR. SMILLIE: I agree with that, and if possible, 

I guess I will withdraw that amendment, if that's 

parliamentary -- possible, and stick with the date that we 

have here to allow the growers to hopefully find substitutes 

for that material prior to the end of 2012.

 MR. DELGADO: Do you agree to withdraw the motion?

 MR. KARREMAN: I am withdrawing the motion. If it 

is possible. 

 MR. DELGADO: It is possible. You have to have 

agreement of the second to do so. Any pressure? 

 MS. JAMES: I feel a lot of pressure, because I 
don't see what the benefit is of us making this change and 

reopening it if we - 

 MR. DELGADO: Tina?

 MS. ELLOR: The benefit would be that it would no 

longer be subject to the normal sunsets, and it would drop 

off. To me, that's a pretty significant benefit.

 MS. JAMES: Well, I guess in my short time in 

observing sunset, things don't just drop off. And there's no 

point in not agreeing to go ahead and withdraw it, because if 

everybody else is saying, let's do it, it'd be a waste of a 

vote. So I accept that. 

 MR. DELGADO: It is withdrawn, and we're going 

back to the original motion of October 21st

 MR. KARREMAN: Is that date, correct date, 

program?

of 2012. 

 MR. DELGADO: It's been confirmed by the director. 

 Tracy, you had a question there? 

 Any other questions on this motion to amend? And 

I have to clarify that. Your motion was to amend the --

 MR. GIACOMINI: The recommendation.

 MR. DELGADO: -- the recommendation. So, and I 

want to make sure I understand, because your motion to amend 
the recommendation presented by the Crops Committee, once 

it's amended, we'll have to do --

 MR. GIACOMINI: We vote on the new recommendation 

as amended. 

 MR. DELGADO: Perfectly stated, and we'll do that. 

 So ready for the question. The question is on 

the amendment - on the motion to amend by adding the - by 

adding tetracycline for fire blight control only on the 

national list 205.601(I) until October 21st

 And we'll start our vote with Barry. 

, 2012. 

 MR. FLAMM: Could you please restate the motion?

 MR. DELGADO: We are voting to consider a motion 

to amend the recommendation of the Crops Committee by adding 

October 21st

 MR. FLAMM: And eliminating the - 

, 2012, as - 

 MR. DELGADO: - and eliminating the different 

forms of tetracycline. 

 MR. KARREMAN: And eliminating sunset too. 

 MR. FLAMM: And all forms of tetracycline will be 

subject to this expiration date?

 MR. DELGADO: As it's stated in the motion, you 

will have that expiration. 
 MR. FLAMM: And that expiration date is?

 MR. DELGADO: October 21st

 MR. FLAMM: I just want to make sure it's in the 

record. 

, 2012.

 MR. DELGADO: Any questions from the rest of the 

board?

 We'll start with the vote. Barry?

 MR. FLAMM: I vote yes. 

 MR. DELGADO: Hugh. 

 MR. KARREMAN: Yes.

 MR. DELGADO: Kevin. 

 MR. ENGELBERT: Abstain. 

 MR. DELGADO: Kevin abstain was the last one?

 Jennifer. 

 MS. HALL: Yes. 

 MR. DELGADO: Steve. 

 MR. DeMURI: Yes. 

 MR. DELGADO: Julie. 

 MS. WEISMAN: Yes. 

 MR. DELGADO: Dan. 

 MR. GIACOMINI: Yes. 

 MR. DELGADO: Jeff. 
 MR. MOYER: 

 MR. DELGADO: Bea. 

 MS. JAMES: Yes. 

 MR. DELGADO: Jerry. 

 MR. DAVIS: Yes. 

 MR. DELGADO: Tina. 

 MS. ELLOR: Yes. 

 MR. DELGADO: Tracy. 

 MS. MIEDEMA: Yes. 

 MR. DELGADO: Joe. 

 MR. SMILLIE: Yes. 

 MR. DELGADO: And the Chair votes yes. 

 MR. MOYER: Mr. Chairman, we have 13 yeses, one 

abstention, and one absent. 

 MR. DELGADO: The motion to amend is agreed to. 

Now we can go on to a discussion of the recommendation as 

amended. 

 (Simultaneous speakers.)

 MR. GIACOMINI: We have amended the 

recommendation. Now we have to vote on the amended 

recommendation. 

 MR. DELGADO: It's procedure so, Mr. Chairman 
would you like to submit the amended motion. 

 MR. GIACOMINI: It is on the record as - the 

motion has been made as it is. 

 MR. DELGADO: Without amending, before we amended 

it.

 MR. GIACOMINI: The motion is in play. The motion 

is on the table already. 

 MR. DELGADO: The motion is on the table. So we 

don't have to present it to the board. Our parliamentarian 

here is stating that we have it before the board. So we have 

discussion -- it has been stated. Now the motion is to set - 

to list tetracycline - adding tetracycline for fire blight 

control only on the national list 205.601(I) until October 

21st

 Questions?

, 2012. That's the motion. 

 MR. GIACOMINI: Clarification, is that the proper 

wording for the program to recognize that as an annotation 

change, saying, adding rather than - and that it's any kind 

of a separation. 

 DR. ROBINSON: We'll just change -- we understand 

it. It just changes the annotation. We got it. 

 MR. DELGADO: Questions? Jerry.
 MR. DAVIS: Why is the 2012 date not attached to 

the part directly -- 

 MS. FRANCES: It's just formatting.

 MR. DAVIS: No, I mean why is it not part of that 

upper sentence? 

 MR. GIACOMINI: She just rewrote it under your 

other vote.

 MS. FRANCES: That was an earlier committee vote.

 MR. DAVIS: Okay, I get you. It's not going to 

show in two places when we're done. That's my question. 

 MS. FRANCES: I mean, obviously you're going to 

give me a final version of this. 

 MR. GIACOMINI: It'll only have one line saying 

what it is not.

 MS. FRANCES: We'll get all this right. 

 MR. DELGADO: Ready for the question? 

 The question is on the motion to add tetracycline 

for fire blight control only on the national list Section 

205.601(I) until October 21st

 And we'll start our vote with Hugh. 

, 2012. 

 MR. KARREMAN: Yes. 

 MR. DELGADO: Kevin. 
 MR. ENGELBERT: Abstain. 

 MR. DELGADO: Jennifer. 

 MS. HALL: Yes. 

 MR. DELGADO: Steve. 

 MR. DeMURI: Yes. 

 MR. DELGADO: Julie. 

 MS. WEISMAN: Yes. 

 MR. DELGADO: Dan. 

 MR. GIACOMINI: Yes. 

 MR. DELGADO: Jeff. 

 MR. MOYER: Yes. 

 MR. DELGADO: Bea. 

 MS. JAMES: Yes. 

 MR. DELGADO: Jerry. 

 MR. DAVIS: Yes. 

 MR. DELGADO: Tina. 

 MS. ELLOR: Yes. 

 MR. DELGADO: Tracy. 

 MS. MIEDEMA: Yes. 

 MR. DELGADO: Joe. 

 MR. SMILLIE: Yes. 

 MR. DELGADO: Barry. 
 MR. FLAMM: Yes. 

 MR. DELGADO: And the chair votes yes. 

 MR. MOYER: Mr. Chairman, we have 13 yeses, one 

abstention, and one absent. 

 MR. DELGADO: The ayes have it and the motion is 

agreed. Right. 

 Well, that concludes our discussion and 

presentation on crops related materials, and we are free to 

continue on with livestock, and Dr. Karreman.