Updated June 17, 2010 

Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program (NOP)

Date: April 29, 2011

Subject: Tetracycline Petition

Chair: Tracy Miedema

 

 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action X

Guidance Statement 

Other 

Statement of the Recommendation (Including Recount of Vote): 

Adopt of the petition to amend the listing for tetracycline to remove the 

expiration date of October 21, 2012 and be annotated as follows:

§205.601 Synthetic substances allowed for use in organic crop production.

(i) As plant disease control.

(12) Tetracycline, for fire blight control in apples and 

pears only until October 21, 2014.

The Board expects that members of the industry will collaborate and coordinate 

efforts in preparing for the eventual removal of this material from the National 

List, specifically optimizing the use of resistant rootstocks and cultivars, 

preventive management methods, and the use of alternative, allowed biological 

and chemical controls whenever warranted.

Rationale Supporting Recommendation (including consistency with 

OFPA and NOP): 

The Crops Committee originally requested, but did not receive, prior to 

adopting its recommendation on tetracycline, an updated Technical Review 

(TR), noting deficiencies in the previous reviews. The committee had a 2006 

TR and a1995 Technical Advisory Panel (TAP) for tetracycline. The committee 

proceeded based on its own research, pending the receipt of the new TR, 

which was reviewed when it is received and found to support the committee’s 

research. 

The antibiotic tetracycline was first approved in November 1995. Tetracycline 

and another antibiotic, streptomycin, were each listed with a split vote. The 
Updated June 17, 2010 

issue of engendering antibiotic resistance in human pathogens and in workers 

was raised in the 1995 TAP review. The annotation that permitted use for “fire 

blight control in apples and pears only” was adopted. Streptomycin antibiotics 

were to be reviewed again in two years, and there was to be a task force to 

further explore antibiotic use in fruit production.

The 1998 proposed rule would have allowed “antibiotics as pesticides.” There 

was public opposition to the use of antibiotics as pesticides. When the USDA 

published the next draft rule in early 2000, it removed the NOSB 

recommendations allowing streptomycin and tetracycline in order to be 

consistent with the prohibition of antibiotics in livestock. The two antibiotics 

were reinstated in the December 2000 final rule in response to comments from 

growers.

Thus, from the very beginning, there has been controversy over allowing these 

chemicals to be used in organic agriculture. The Board discussion regarding 

the 2006 sunset included concerns about:

 Promotion of resistance in human pathogens

 Natural substitutes

 Inconsistency with the prohibition of antibiotics in livestock

 Inconsistency with organic principles

 Disagreement with the prophylactic use of antibiotics

 The Centers for Disease Control and Prevention (CDC) opposition to the 

use of streptomycin and tetracycline in crop production

 Failing to give an incentive for alternatives

 Reaction against organic fruit by consumers

 Possibility that antibiotics might be taken up by fruit trees

 Need for more research

 Restrictions on sales of fruit in Europe

 Disruption of the organic system.

And on the other hand,

 Lack of data showing impact on resistance in human pathogens

 Dependency of growers on the materials

Ultimately, after expressing concern and the wish that someone might petition 

to remove them sooner than the next sunset, the two antibiotics were renewed

with a vote of 7 yes, 4 no, 1 abstention, and 2 absent.

At its November 2008 meeting, the Board took up a petition to add a second 

form of tetracycline —oxytetracycline hydrochloride, by removing the 

tetracycline annotation that limited its use to the “oxytetracycline calcium 

complex.” This would have reset the clock on the tetracycline sunset. However, 

because there was a general belief that tetracycline should be phased-out, the 
Updated June 17, 2010 

Board voted down the proposal; 1 yes, 13 no, and 1 absent. However, after 

that vote, a motion to reconsider resulted in hydrochloride being added (“to 

level the playing field”), as well as an annotation that turned the sunset date 

into an expiration date —October 21, 2012— thus seeking to prevent any 

additional extensions of the sunset period.

Now tetracycline has come to Board again in a petition that requests the 

removal of the annotation, the 2012 expiration date. The committee found that 

the case against the antibiotic has grown stronger and that removal from 601 

should be delayed no longer than necessary. 

The Crops Committee was presented with evidence that tetracycline can 

contribute to antibiotic resistance in human pathogens when used as pesticides 

on plants. At the same time, additional products are available for use against 

fire blight. Serenade Max, Bloomtime Biological FD, BlightBan C9-1 and 

Blightban A506 are relatively new biological controls. Surround is a kaolin clay 

product that has had some success in controlling fire blight.

Many in the public believe that the first line of defense is the choice of resistant 

varieties and rootstocks, a concept that the committee majority stated is a

critical organic principle, essential to disease or pest prevention in organic 

systems. Despite this, the pattern of growth in organic apple and pear varieties 

in certain areas of the country has been skewed toward those varieties most 

susceptible to fire blight. In 2010, the leading organic apple varieties grown in 

Washington state were Fuji, Gala, and Granny Smith and accounted for 

approximately 54% of organic apple acreage —all highly susceptible to fire 

blight. (Some other widely-planted varieties are also highly susceptible.) The 

leading varieties in organic pear production were Bartlett, D’Anjou, and Bosc —

80% of organic pear acreage— again among the most susceptible to fire blight. 

On the other hand, there are numerous apple and pear varieties that are not 

susceptible to fire blight.

Given the public health threat associated with antibiotic resistance, there is a 

history of Board and public concern that organic production not contribute in a 

small or large way to antibiotic resistance. The Committee originally passed a 

motion denying the petition, but based on comments that more time is needed 

to make a transition, proposed that the expiration date be postponed until 

October 21, 2014.

 

The options for new antibiotics with efficacy are eluding us as resistance 

continues to increase, and the committee feels antibiotic resistance in human 

pathogens is an issue that should drive a process to speedy adoption of 

alternative management of fire blight. 
Updated June 17, 2010 

NOSB Vote:

Moved: John Foster Second: Steve DeMuri

Yes: 13 No: 1 Abstain: 0 Absent: 0 Recusal: 0
Decision Sheets 

December 2006 

NOSB COMMITTEE RECOMMENDATION 

Form NOPLIST1. Committee Transmittal to NOSB 

For NOSB Meeting: April 2011 Substance: Tetracycline __ 

Committee: Crops X Livestock  Handling  Petition is for: __ 

on the National List § 205.601(i)(12)

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

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

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

3. Compatibility & Consistency Yes  No X N/A 

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

B. Substance Fails Criteria Category: 1,2,3 Comments: 

Codex._____________See following evaluation.____________________________________________________________ 

___________________________________________________________________________________________________

C. Proposed Annotation (if any): _ for fire blight control in apples and pears only until October 21, 2014. 

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

D. Recommended Committee Action & Vote, including classification recommendation (State Actual Motion): 

______________________________________________________________________________________________

Classification of the material: Synthetic ____ X___ Non- synthetic_____________ Absent:_________ Abstain _____ 

Motion by: _______________ Seconded:________________ Yes: _____ No: _____ Absent: _______ Abstain: _______ 

Recommended Committee Action & Vote 

The Crops Committee recommends adoption of the petition to amend the listing for tetracycline to remove the expiration date of 

October 21, 2012 and be annotated as follows: 

§205.601 Synthetic substances allowed for use in organic crop production. 

(i) As plant disease control. 

(12) Tetracycline, for fire blight control in apples and pears only until October 21, 2014. 

The Committee expects that members of the industry will collaborate and coordinate efforts in preparing for the eventual 

removal of this material from the National List, specifically optimizing the use of resistant rootstocks and cultivars, preventive 

management methods, and the use of alternative, allowed biological and chemical controls whenever warranted. 

___________________________________________________________________________________________________ 

 

Motion by: _Colehour Bondera________ Seconded:_Barry Flamm___ Yes: _7__ No: _0__ 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. ______Describe why material was rejected: 

4) Substance was recommended to be deferred because _________________________________________________________ 

If follow-up needed, who will follow up _____________________________________________________________________ 

Crops x Agricultural Allowed1

 x 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic x Rejected3

No restriction Commercially UnAvailable as Organic1

 Deferred4 

E. Approved by Committee Chair to transmit to NOSB: 

______________________________________ _________________________ 

 Committee Chair Date
Decision Sheets 

December 2006 

EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST 

Category 1. Adverse impacts on humans or the environment? Substance: Tetracycline 

 

Question Yes No N/A1Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from 

manufacture, use, or disposal? 

[§205.600 b.2] 

 X . 

2. Is there environmental 

contamination during 

manufacture, use, misuse, or 

disposal? [§6518 m.3] 

X TR11

 149-164 

Daniels, 1982.2

Manufacture results in discharges of solvents, detergents, 

disinfectants. 

Treated plants exude tetracycline. 

3. Is the substance harmful to the 

environment and biodiversity? 

[§6517c(1)(A)(i);6517(c)(2)(A

)i] 

X Thiele-Bruhn and Beck, 2005.3

See #6 below. 

4. Does the substance contain List 

1, 2, or 3 inerts? [§6517 c (1 ) 

(B)(ii); 205.601(m)2] 

? 

5. Is there potential for detrimental 

chemical interaction with other 

materials used? 

[§6518 m.1] 

X Burgos et al, 2003.4

Bacteria with multiple resistance. 

6. Are there adverse biological and 

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

X Thiele-Bruhn and Beck, 2005 

Shifts fungal-bacterial balance at environmentally relevant 

concentrations.

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5] 

X Xiujie Xie et al, 2010.5

 

Tetracycline may be genotoxic to plant cells. 

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

 [§6518 m.2] 

X See #10 below. 

9. Is there undesirable persistence 

or concentration of the 

material or breakdown 

products in 

environment?[§6518 m.2] 

X Daniels, 1982. 

Chander et al, 2005.6

Halling-Sørensen et al, 2002.7

Tetracycline is taken up by plants and appears in all 

tissues and in exudates. 

Soil-bound tetracycline maintains biological activity. 

 

1

 TR1 is TR dated January 27, 2006. 

2

 MJ Daniels, 1982. Editorial: Possible effects of antibiotic therapy in plants. Reviews of Infectious Diseases 4 

(Supp): 167-170. 

3

 Sören Thiele-Bruhn, and Iris-Constanze Beck, 2005. Effects of sulfonamide and tetracycline antibiotics on soil 

microbial activity and microbial biomass. Chemosphere, Volume 59, Issue 4, April 2005, Pages 457-465 

4 Burgos JM, Ellington BA, Varela MF., 2005. Presence of multidrug-resistant enteric bacteria in dairy farm 

topsoil. J Dairy Sci. 2005 Apr;88(4):1391-8. 5

 Xie, X., Zhou, Q., Bao, Q., He, Z. and Bao, Y. , Genotoxicity of tetracycline as an emerging pollutant on root 

meristem cells of wheat (Triticum aestivum L.). Environmental Toxicology, n/a. doi: 10.1002/tox.20567 

6 Chander Y, Kumar K, Goyal SM, Gupta SC, 2005. Antibacterial activity of soil-bound antibiotics. J Environ 

Qual. 2005 Oct 12;34(6):1952-7. Print 2005 Nov-Dec. 7

 Halling-Sørensen B; Sengeløv G; Tjørnelund J, 2002. Toxicity of tetracyclines and tetracycline degradation 

products to environmentally relevant bacteria, including selected tetracycline-resistant bacteria.

Archives of environmental contamination and toxicology 2002;42(3):263-71. 
Decision Sheets 

December 2006 

Degradation products have same activity as parent. 

10. Is there any harmful effect on 

human health? [§6517 c (1)(A) 

(i) ; 6517 c(2)(A)I; §6518 m.4] 

X TR163-71, 279-293 

Lugo-Melchor et al, 2010.8

Levy et al, 1976.9

http://en.wikipedia.org/wiki/Tetracycline_antibiotics

“Prop 65 list” 

http://www.oehha.org/prop65/prop65_list/files/P65single3

405.pdf

Workers are at risk of contracting tetracycline-resistant 

disease and suffering from allergic reactions. 

As a consequence of the widespread use of tetracyclines, 

the emergence and spread of tetracycline-resistant 

bacterial pathogens, among them the foodborne pathogen 

Salmonella enterica, has become a serious health hazard 

worldwide. 

Workers who handle feed with tetracycline have 

tetracycline-resistant flora in their intestines. 

Tetracyclines remain the treatment of choice for infections 

caused by chlamydia (trachoma, psittacosis, salpingitis, 

urethritis, and L. venereum infection), Rickettsia (typhus, 

Rocky Mountain spotted fever), brucellosis, and 

spirochetal infections (borreliosis, syphilis, and Lyme 

disease). In addition, they may be used to treat anthrax, 

plague, tularemia, and Legionnaires' disease. 

They may have a role in reducing the duration and 

severity of cholera, although drug-resistance is occurring, 

and their effects on overall mortality is questioned. 

Developmental toxin listed by the state of California. 

 

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. 

 

8

 Lugo-Melchor, Y., Quinones, B., Amezquita-Lopez, B.A., Leon-Felix, J., Garcia-Estrada, R., Chaidez, C. 2010. 

Characterization of tetracycline resistance in Salmonella enterica strains recovered from irrigation water in the 

Culiacan Valley, Mexico. Microbial Drug Resistance. 6(3):185-190. 

9 Stuart B. Levy, M.D., George B. FitzGerald, Ph.D., and Ann B. Macone, B.S., 1976. Changes in Intestinal Flora 

of Farm Personnel after Introduction of a Tetracycline-Supplemented Feed on a Farm. N Engl J Med 1976; 

295:583-588.
Decision Sheets 

December 2006 

Category 2. Is the Substance Essential for Organic Production? Substance: 

 

Question Yes No N/A1Documentation 

(TAP; petition; regulatory agency; other) 

1. Is there a natural 

source of the 

substance? 

 [§205.600 b.1] 

 X . 

2. Is there an 

organic 

substitute? 

[§205.600 b.1] 

 X 

3. Is the substance 

essential for 

handling of 

organically 

produced 

agricultural 

products? 

[§205.600 b.6] 

 X 

4. Is there a wholly 

natural substitute 

product? 

 [§6517 c 

(1)(A)(ii)] 

 X TR1 304-312. 

Stockwell and Stack, 200710

5. Is the substance 

used in handling, 

not synthetic, but 

not organically 

produced? 

 [§6517 c 

(1)(B)(iii)] 

 X 

6. Are there any 

alternative 

substances? 

[§6518 m.6] 

 X TR1 317-330 

7. Is there another 

practice that 

would make the 

substance 

unnecessary? 

[§6518 m.6] 

 X TR1 297-302, 335-343. 

Aldwinckle et al, 199811. 

“Fireblight Management in the Pacific Northwest USA” 

(http://www.ncw.wsu.edu/treefruit/fireblight/principles.htm)

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. 

 

 

10 Stockwell, V. O., and Stack, J. P. 2007. Using Pseudomonas spp. for integrated biological control. Phytopathology 97:244-249. 11 H. Aldwinckle, J Norelli, and MT Momol, 1998. Fire blight: the search for better control. IDFTA Compact Fruit 

Tree, Vol. 31, No. 4 
Decision Sheets 

December 2006 

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

Substance: 

 

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, and 

biodiversity? [§6517 c (1)(A)(iii); 

6517 c (2)(A)(ii)] 

 

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7] 

 

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3] 

 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; 

 

 

b. toxins derived from bacteria; X 

c. pheromones, soaps, horticultural 

oils, fish emulsions, treated seed, 

vitamins and minerals? 

 

d. livestock parasiticides and 

medicines? 

 

 

e. production aids including netting, 

tree wraps and seals, insect traps, 

sticky barriers, row covers, and 

equipment cleaners? 

 

1

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

 X 

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling? 

 X 

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quality to fulfill an essential function 

in a system of organic handling? 

 X 

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quantity to fulfill an essential 

function in a system of organic 

handling? 

 X 

5. Does the industry information 

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); 

 X 

b. Number of suppliers and amount 

produced; 

 X 

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

 X 

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or 

 X 

e. Are there other issues which may 

present a challenge to a consistent 

supply? 

 X