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________________________________ 

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: Comments: 

C. Codex._____________See following evaluation.____________________________________________________________ 

___________________________________________________________________________________________________

D. Proposed Annotation (if any): _________________________________________________________________________ 

____________________________________________________________________________________________________ 

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

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

______________________________________________________________________________________________

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

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

Recommended Committee Action & Vote The majority of the Crops Committee recommends against the adoption 

of the petition to amend the listing for tetracycline by removing the expiration date on tetracycline so that 

the listing would state “tetracycline, for fire blight control only,” thus allowing tetracycline’s use to expire 

on October 21, 2012. ___________________________________________________________________________________________________ 

 

Motion by: _Jay Feldman________ Seconded:_Tina Ellor___ Yes: _0__ No: _5__ Absent: __2____ 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

 

Livestock Non-Synthetic Prohibited2 

Handling Synthetic x Rejected3 x 

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