This is a work product of the National Organic Standards Board (NOSB). It does not represent official National Organic 

Program (NOP) positions or policy.

National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Oxytetracycline

February 5, 2013

Summary of Proposed Action:

The Crops Subcommittee proposes to:

Remove the existing expiration date of October 21, 2014 for oxytetracycline and replace that with a 

new expiration date of October 21, 2016. This would be for use in both apples and pears for control 

of fire blight.

The Crops Subcommittee would also like to put forward this resolution:

Resolution: The National Organic Standards Board is committed to the phase out of this material. 

Between now and 2016 the Board urges growers and certifiers to include in organic systems plans 

an annual increase in the extent and/or number of alternative practices and materials that are 

trialed for controlling fire blight. In addition, the board strongly advocates to USDA a high priority for 

increased support for research into these alternative practices and materials.

Introduction

A Petition to the National Organic Standards Board (NOSB) was received for Removal of the 

Expiration Date (October 21, 2014) for the Authorized Use of Tetracycline for the Control of Fire 

Blight in Apples and Pears. It was furthermore requested by the petitioner to reinstate Tetracycline to 

the sunset process.

Because this subject is complex and there are two different positions to be represented, this 

recommendation is organized to include a brief history of previous NOSB decisions involving this 

substance, followed by two separate discussion sections from those for (Majority Position) and 

against (Minority Position) an extension. These are designed to supplement the points raised in the 

checklist.

The sub-committee acknowledges the concerns of consumers and previous NOSB members who 

feel that it is time to phase this material out from organic agriculture. The two positions represented in 

the discussion section of this document differ on the timing of the phase-out. Additional concerns are 

being put forward in a separate resolution on the subject.

Background

NOSB History on Tetracycline in Fruit Production

1995- A TAP review on “Antibiotics” was reviewed by the NOSB. All three reviewers thought that 

tetracycline and streptomycin were non-synthetic. Voted on Nov. 1995 as three separate 

Listings:

Antibiotics (Avermectin) – failed 3-6-4
Antibiotics (Streptomycin sulfate) – Determined to be synthetic; vote – unanimous. The 

NOSB’s decision is to allow this material for use in organic crop production; vote: 10 aye/3 

opposed. Annotation: Permitted for use as a fire blight control in apples and pears only. To be 

reviewed again in two years.

Antibiotics (Terramycin – Oxytetracycline calcium complex) – Determined to be synthetic; vote 

– unanimous. The NOSB’s decision is to allow this material for use in organic crop production; 

vote: 10 aye/ 1 opposed/2 abstentions. Annotation: To be reviewed again in two years.

No discussion was given in transcript except that the NOSB was to set up a task force to look 

further into these materials in the two year time frame.

2006 - A TR commissioned by the NOSB for the sunset review was received in January 2006. Sunset 

review of Tetracycline and Streptomycin in April 2006. (discussion 4/20/06 pp.41-78) 

Discussion is worth reading because of the wide variety of concerns raised from the concern of 

the CDC for antibiotics in the environment to the quantity of pear trees being cut down in 

Romania and other European Union (EU) countries. Mr Neal from the NOP stated that the 

board should not be making changes in annotation during sunset especially because nobody 

presented any economic impact data in the Sunset Federal Register notice for removal of 

these materials.

The Crops Committee recommends renewing the materials listed in Section (i) as plant 

disease control. Streptomycin and tetracycline for fire blight control in apples and pears. 7-4-1-

2 (p.411)

2007- A petition was received to add Oxytetracycline hydrochloride to the National List. 

Oxytetracycline calcium complex is the form already on the list and the petitioned form is 

similar but from a different manufacturer.

2008 - The NOSB reviews the new petition for adding another form of tetracycline (Oxytetracycline 

hydrochloride) at their public meeting November 19, 2008. The 2006 TR was used for the 

checklist, with some supplemental references. The committee recommendation to add 

oxytetracycline hydrochloride for fire blight control only to NL §205.601 (i) failed: 0-6-0-0. The 

committee recommendation states: “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”.

At the NOSB meeting, Dr. Robinson indicated that adding a new form to the existing listing 

would “reset the clock” for another 5 years until sunset. The motion to add the Oxytetracycline 

hydrochloride failed unanimously. However, an NOSB member then moved to reconsider the 

listing vote because of “new information regarding possible action on this petition.....” The 

NOSB then voted to reconsider the vote before it was stated what the new information was. 

This passed: 11-0-1-2.

The next motion was “to change....the listing and annotation of tetracycline to read: 

tetracycline for use only in organic crop production for fire blight control until October 21st, 

2012”. After an effort to change the date to December 2009, but the NOP stated that they 

could not get a rule change out by then, this motion was voted with no further public comment. 

Vote was: 13-0-1-1 to amend the original recommendation. On the motion to add tetracycline 

for fire blight control only on the National List Section 205.601 (I) until October 21st, 2012. Vote: 

13-0-1-1.
2010 – A petition was submitted to remove the Expiration Date for Tetracycline, in accordance with 

75 FR38696 where the NOP states: “...we note the NOSB’s recommendation to only allow the 

continued use of tetracycline for fire blight control until October 21, 2012. Though some 

commenters have requested the removal of the expiration date from the use of tetracycline, 

the NOP recommends that such interested parties petition the NOSB using the petition 

process outlined in 72 FR 2167 (January 18, 2007) to have the expiration date removed from 

the authorized use of the substance”. 

2011 – Review of Petition to remove Expiration Date for Tetracycline. A new TR was commissioned. 

The Crops Committee did not receive it before issuing their recommendation, but did review

their decision in light of the TR. The TR was posted for public view on the last day of the 

written comment period.

At the April 2011 meeting the NOSB recommended to:

“Adopt 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 substance 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 NOSB 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”.

Discussion Regarding NOSB History

From the perspective of 2012 looking back on the previous actions of the NOSB and NOP, there are 

inconsistencies and errors along the way. A few of the most apparent are:

• The task force and two year review was never implemented after the 1995 recommendation.

• The vote to re-list in the first sunset review in 2006 was not a 2/3 majority as is required today.

• The 2008 decision to change from adding another form of tetracycline to the National List to a 

firm expiration of all forms in 2012 was done without a written public comment period. What 

happened at the meeting was different from the recommendation on the petition that was posted 

in advance.

• The proposed rule that followed the 2008 decision received some public comment about 

economic harm but not enough to trigger a USDA economic impact review, even though the 

2006 statement from the NOP indicated such impact must be considered.

• The public did not have access to the TR during the written public comment period prior to the 

2011 recommendation, but NOSB members did.

• The 2011 proposed rule to extend the sunset date to 2014 again did not result in an economic 

impact review by the USDA.

Discussion of the Extension Position (Majority Position)
Because of the very large investment of time and money that establishing an orchard entails, the 

variety of locations that apples and pears are grown, and the very rudimentary state of research on 

alternatives to this material in that variety of locations, we are supporting slowing down the removal of 

tetracycline from the National List.

Since the organic pear industry is more at risk to fire blight than apples (see Pear Perspective later in 

this document) there is concern that pear research and control measures are lagging behind and that 

an expanded time frame will be needed.

A slightly extended date of 2016 will benefit consumers and growers alike. The few more seasons of 

research will enable new products to be tested in both apples and pears in a variety of weather 

conditions. Allowing the new EPA data to be reviewed will inform many of the unanswered questions 

stakeholders may have about oxytetracycline. 

Because of the need to make sure that this material is phased out, a resolution motion has been 

added to affirm the commitment by the NOSB to all organic stakeholders. The NOSB must ensure 

that the decisions made reflect due consideration of the various needs and concerns of the vast array 

of all our organic stakeholders, especially when dealing with complicated issues, such as this one.

This section focusses on how the material is used in the context of both plant and human health. 

Specific portions address Checklist categories as noted.

Introduction

In 2009, about 15% of the total apple area and 40% of the pears (organic and conventional) were 

treated with streptomycin or oxytetracycline for control of fire blight, the disease caused by the 

bacteria Erwinia amylovora.

The core issue here is whether there is a risk of enhancing antibiotic resistance in human pathogens. 

The most astute and experienced scientists in this area realize that science and medicine have to find 

a way to co-exist with resistance, including managing reservoirs of resistance in the environment and 

preventing development of new forms of resistance. (Am. Academy of Microbiology, 2009)

While oxytetracycline is used to treat a wide variety of human bacterial infections and diseases, the 

2011 TR (lines 593-597) cites the Centers for Disease Control and Prevention (CDC) as indicating 

that resistance has not yet occurred for these drugs. Also mentioned is that there are alternative 

antibiotics to oxytetracycline for human illness.

In fact, the American Academy of Microbiology review of Antibiotic Resistance (2009) states that 

biocides, such as triclosan or quaternary ammonium compounds, may represent a more important 

threat to the future of antibiotics than antibiotics themselves. Because they have become so 

widespread in consumer products at sub-lethal concentrations, they promote the evolution of bacterial 

resistance. Other environmental factors that can contribute to resistance include the use of sewage 

sludge and water from sewage facilities, overuse of non-antibiotic drugs, and other chemical 

stressors that contribute to selective pressure such as heavy metals in animal feeds.

The EPA is reviewing the pesticide registration for oxytetracycline. (US EPA, 2008) Part of this review 

will include environmental fate data as well as the potential for antibiotic resistance transfer from plant 

pathogens to human pathogens. The EPA's final registration review decision and information is 

scheduled for 2014. (TR lines 609 - 612) While the EPA studies only a risk assessment point of view 

which is not the same as the full spectrum of criteria that the NOSB considers, this review is 
particularly important because it is calling for additional ecological data, such as aquatic toxicity to 

both plants and animals, terrestrial plant toxicity, honeybee toxicity, and avian reproduction studies. 

They are expecting an immunotoxicity study to determine whether repeated exposure from 

oxytetracycline will affect the immune system. After the docket closes in June 2014 the EPA will 

develop a final work plan and schedule for registration review of oxytetracycline, expected in 

September of 2014. 

Quantity and Use Patterns

In 2009 in the US, 16,465 kg (active ingredient) was applied to orchards, which is 0.12% of the total 

antibiotics used in animal agriculture (Stockwell and Duffy, 2012)

In the USA, the preharvest interval for application of oxytetracycline and streptomycin varies from 

between 21 and 60 days, depending upon the compound and the crop. (McManus & Stockwell, 2001)

Resistance in Erwinia amylovora (Fire Blight)

While there are three major strategies for developing tolerance, efflux pumps, alteration of the 

ribosome to block binding, and production of enzymes to inactivate the material, resistant strains to 

tetracyclines have not been detected in orchards in the USA (McManus et al., 2002)

This plant pathogen does not develop resistance in the laboratory during exposure to oxytetracycline. 

In laboratory experiments, E. amylovora will be resistant to tetracycline if resistance genes are 

introduced. Nonetheless, there are no examples of acquisition of tetracycline-resistance genes by E. 

amylovora in orchards. This, in part, may be due to low populations of tetracycline-resistant plant 

associated bacteria on flowers in fruit orchards that could be a potential source of resistance genes.

(Schnabel and Jones, 1999) In orchards treated with antibiotics, only 5% of the bacteria isolated from 

flowers or leaves was resistant to oxytetracycline (10 μg/ml). (Schnabel and Jones, 1999)

Checklist Discussion:

Category 1, Questions 8 and 9: Mode of Action, Breakdown, and Residues

Mode of Action

Oxytetracycline inhibits the multiplication of bacterial cells by binding reversibly to the bacterial 

ribosome and blocks proteins while bound. (McManus et al., 2002)

Bacteria from the environment migrate to the flowers over time given favorable environmental 

conditions. As flowers develop and form fruit tissues, detectable populations of bacteria decrease and 

are restricted to the stem end and the calyx end of the fruit. Intact waxy surface of the fruit does not 

support bacterial growth. 

Breakdown

Even though they can be detected on plant surfaces for up to a month after application, their capacity 

to inhibit bacterial growth is lost within a week after application. Oxytetracycline is thermostable on 

leaves, but rapidly degrades when exposed to natural sunlight. 44% within 1 day, 92% within 4 days, 

and near the detection limit of 50 ppb by a week after application. (Christiano et al., 2010) It is not 

rainfast on leaves: 2 minutes of simulated rain reduced residual concentrations by 67% and an hour 

reduced it near the detection limit. (Christiano et al., 2010)

The 2011 TR points to a study by Chander et al. (2005) that tetracycline remains biologically active 

even while tightly adsorbed to clay particles in soil. (lines 322 – 323) This is used to bolster the 
concern that the residues persist in the environment and may contribute to bacterial resistance. This 

study however was done in a lab using soil that was centrifuged and innoculated for 24 hours at 

concentrations many times higher than even a manure application would contribute, much less a 

foliar spray. This 24 hour time frame tells nothing about persistence in environmental conditions, nor 

does it acknowledge the role of light in breaking down the material. Other research indicates that the 

bioavailability of tetracyclines is limited in soil because it forms strong bonds with metals and organic 

matter. (Lui et al, 2009; Popowska et al, 2012) The relative activity and breakdown is strongly 

influenced by soil composition, shifts in microbial populations, exposure to light and other 

environmental factors (TR lines 458- 467).

The petitioner, in their rebuttal to the NOSB 2011 recommendation (submitted with the 2012 petition), 

states that tetracycline breaks down into 3 by-products found in the soil and much lower levels than 

the parent compound and with much reduced antibacterial potencies. The tetracycline molecule has a 

strong affinity to form chelates or complexes with divalent cations. This action reduces the 

bioavailability of oxytetracycline as well as its antibacterial effects, rendering it inactive in soils 

through a combination of degradation, absorption, and chelation. (Halling-Sorensen et al., 2002) This 

research was done on tetracycline being applied in animal manure, at much higher concentrations 

and with a lot of supplemental nitrogen than would be found in tree fruit applications.

A statement in the NOSB 2011 recommendation checklist (Category 1, Question 9) for tetracycline 

states that "Tetracycline is taken up by plants and appears in all tissues and exudates." This is not 

fully borne out in literature. While it has recently been shown that it can be taken up by annual plants 

from soil after a manure application (Kumar et. al., 2005), it is not always the case for all plants and 

has not been shown for perennials.

Residue on Fruit

For oxytetracycline the residue tolerance level on tree fruit crops is 0.35 ppm. To date there are no 

reports of fruit with residues greater than this. In a risk assessment study the EPA states that typical 

pharmaceutical oxytetracycline exposure to humans would be 50,000 to 200,000 times greater that 

the theoretical dietary exposure. (US EPA 2008)

Residue data for oxytetracycline were reported by the U.S. EPA (2005) as part of the process to allow 

the material to be used on apples. Field trials were conducted in various parts of the country. 

Oxytetracycline was applied at rate from 0.5 to 11 times the proposed seasonal rate of 1.53 lb 

a.i./acre, and at 49-60 days before harvest. The Limit of Quantification was 0.013 ppm. Most samples 

were at or below this limit, while the highest residue level detected was 0.252 ppm. There was no 

dose response to increasing rates in the residue data. No data were reported for trees treated only 

once or twice during bloom, which is the most common use pattern in the western U.S. (Stockwell 

and Duffy 2012)

Category 1, Question 10

Potential for Humans to build Resistance to Medical Tetracyclines

There are numerous reports that the use of antibiotics in animal production is associated with 

increase of antibiotic-resistant bacteria in animals, waste-water, and manure (for some examples see 

Larsen 2010, Wright 2010). A direct linkage was reported between infection and colonization of 

humans by antibiotic resistant bacteria from farm animals. (Larsen et al 2010) No direct linkage has 

been demonstrated between antibiotic resistant bacteria in humans and antibiotic sprays on plants.

(Stockwell and Duffy, 2012)

The TR from 2011 cites an article by Rezzonico et al. (2009) that other countries have placed 

restrictions on antibiotics due to concerns about horizontal transfer of resistance genes from bacterial 
in the agricultural setting to clinically relevant bacteria. However such a link has never been 

documented (2011 TR lines 614 - 616) and this article only referred to streptomycin and not to 

oxytetracycline.

Models generated by the EPA indicate that the potential for direct exposure of humans and their 

microflora to antibiotics deployed for crop protection is several thousand-fold less than for the medical 

use of antibiotics. (US EPA 2006a, 2006b, 2008)

For humans, tetracyclines are administered at doses between 1000 mg to 2000 mg daily for at least a 

week (http://www.drugs.com/dosage/tetracycline.html) or a minimal exposure of 7,000 to 14,000 mg 

during a prescribed cycle. To date, there are no reports of fruit with residues at or above the permitted 

tolerance for oxytetracycline at 0.35 mg/kg fruit. 

In the Code of Federal Regulations (21CFR556, Sec. 556.720: Tetracycline), the acceptable daily 

intake (ADI) for total tetracycline residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 

micrograms per kilogram of body weight per day. The ADI is an estimate of the amount of a 

substance which can be ingested daily over a lifetime by humans without appreciable health risk. For 

a 100 kg person, the ADI for tetracyclines is 2.5 mg. If a person ate fruit with oxytetracycline residues 

of 0.35 mg/kg fruit, then they would need to consume 7 kg of fruit daily or 47 apples (150 g) each day 

to reach the ADI. (Stockwell et al., 2013)

Human pathogens have not been detected in surveys (Pusey et al., 2009) of genera of bacteria on 

flowers of fruit trees. Given this, direct enrichment of antibiotic-resistant human pathogens from 

antibiotic sprays on plants is unlikely.

It is well established that bacteria harboring transmissible antibiotic resistance genes are common in 

the environment, even in environments that have never been exposed to exogenous antibiotics.

(Duffy et al., 2011; Popowska, et al., 2012; Sundin and Bender, 1996) Given that human pathogens 

are not common colonizers of pome fruit flowers, the probability of direct acquisition of antibiotic 

resistance genes from resident phyllosphere bacteria in the tree canopy is reduced. (Stockwell and 

Duffy, 2012)

Even those most concerned about spread of antimicrobial resistance state that the molecular details 

of the emergence of resistance genes "...suggest that an enormous number of encounters between 

agent and germs have been needed to produce the first emergence of most resistance genes." 

(O'Brien, 2002) Presumably, this resistance would first be seen in the target organism, Erwinia 

amylovora, since it has far more "encounters" than any human pathogen organism would have in an 

orchard. Yet this has not been the case. This same article continues that resistance in the bacteria for 

the first host is key to making it more likely to transfer to a second strain on another host. The 

implication is that the resistance gene has to come into contact with human or animal pathogenic 

bacteria in order to move out of the orchard environment. Since plant hosts are not mobile in the way 

humans or animals are, the chances of this happening mean that the alternate host has to come into 

the orchard while the material is still active.

During the process of spraying, a portion of the material lands on the orchard floor. The supposition 

that resistance genes could build up in the soil has not been supported by recent studies. (Duffy et 

al., 2011; Popowska, et al., 2012; Walsh, et al., 2011) Tetracycline is absorbed onto soil particles and 

rapidly rendered inactive. (Subbiah et al., 2011) The authors of this study speculate that antibiotic 

residues from foliar applications would have minor effects, if any, in increasing antibiotic resistance 

genes in soils.
Conclusion

There is no evidence that applications of antibiotics to orchards during bloom contributes to antibioticresistance in human pathogens. Human pathogens have not been found in orchards and would have 

to be present for the resistance genes to transfer. (Stockwell and Granatstein, 2013) The fire blight 

organism has not shown any signs of resistance itself, thus negating the first step in the transfer of 

potential resistance genes. The tetracycline is active for a very short time period on plant tissues and 

it is long before harvest. (Christiano et al, 2010) Naturally occurring tetracycline resistant bacteria 

may be minor components of the overall bacterial communities found on apple flowers and in soils, 

but their presence is independent of the antibiotic application. The amount and timing of the use of 

this material in an orchard environment does not contribute to any human health concerns.

Checklist Discussion Continued:

Category 2 Questions 9 and 10: The Pear Perspective

Fire blight disease caused by Erwinia amylovora poses unique challenges in pears. Because pears 

bloom earlier than apples in general and the bloom can last for a longer period, they are often more 

susceptible to fire blight. This discussion focusses on some issues unique to pears because their 

production will be more challenged by the expiration of oxytetracycline.

Pear growers use integrated management to control fire blight that includes removing infected wood 

during pruning and spraying copper at early green-tip help to reduce inoculum levels before the 

growing season. Preventive sprays of oxytetracycline and/or streptomycin are used because 

applications before infection are known to be more effective than those applied after infection.

(Adaskaveg, 2010; Keil & Wilson, 1962) These preventive sprays are based on predicted weather 

conditions from computer models such as Cougar Blight or Maryblyt Model. However these models 

are better at predicting high-infection risk from in the primary bloom that is relatively short but not in 

the secondary (rat tail) bloom that can last two months. (Holtz et al., 1999; Holtz et al., 2002) They 

also failed to predict warm dew infection periods during rainless weather in the Central Valley of 

California. (Holtz et al., 2002) The Zoller Degree Hour Model (Zoller, 2000) is widely used in pears 

and can predict the build-up of the causal bacteria in blossoms, as well as suggesting risk-based 

changes in treatment frequency needed during rainless infection periods. Refinements of all the 

models is ongoing, but each pear region needs a model tailored to the local specific growing 

conditions; something not currently available.

Pear varieties show less variation in resistance than apples and are generally more susceptible to fire 

blight. (Granatstein et al., 2011) A few "blight resistant" cultivars have been developed but these have 

not shown full resistance in all locations and have not been popular with consumers.

The alternatives to oxytetracycline and streptomycin are not as well researched in pears as in apples, 

but some of the same limitations are more pronounced in pears. Coppers are being tested at greentip stage in pears but cannot be used at bloom or after on clear-skinned fruit because they cause fruit 

russetting, rendering the fruit unmarketable. The biological antagonists such as Pseudomonas 

fluorescens A506, or Pantoea agglomerans strains C9-1 and E25 have either not been tested for as 

long a period of time in pears and/or the results have been inconsistent. The new yeast product, 

Blossom Protect, has only been tested for one year in pears. The biological products also must be 

separated in time from the use of coppers or lime-sulfur, thus possibly interfering with scab 

treatments. The use of alternative treatments has also resulted in increased russet and loss of fresh 

market quality. (Zoller, 2011)

In general organic production of pears has lagged behind that of apples largely because of the fire

blight problems. Pears take 6 to 7 years to bear their first significant commercial crop and live for 50 

to 80 years, so a planting is a larger investment in time and not as easy to replace as apples, which 
can produce in 3 to 4 years and live 20 to 50 years. A very limited quantity of pears is now produced 

without antibiotics for the EU market. These blocks often have to be removed from an EU program 

periodically to address fire blight infections.

Conclusion for Majority Position

The organic farming sector is committed to developing and implementing a non-antibiotic approach to 

controlling fire blight in organic apples and pears. Some progress has been made in recent years to 

identify research needs, secure some research funding, and take an initial look at some promising 

alternative controls. Because apple and pear growers are spread throughout a majority of the country 

and are decentralized in organization, the relevant regional research and extension of those results 

will not reach all the growers by the 2014 expiration date. 

Retaining that date could potentially cause immense financial loss for a variety of organic 

stakeholders and could cause many producers to go out of business. Their fruit could potentially be 

replaced with organic fruit from Chile, China, and various other countries where there is no fire blight, 

or with conventionally grown fruit containing a full array of chemicals.

A short extension will benefit organic stakeholders that could be affected by this decision, such as 

consumers, producers, handlers, and retailers. Giving producers a chance to have good access and 

experience with other control methods will make sure that consumers have a choice of variety of 

organic fruit in the marketplace that they have grown accustom to having.

Discussion of the Position to Allow Expiration of Oxytetracycline Listing in October 2014

(Minority Position)

It has been clear for several sunset and expiration reviews that environmental and consumer groups 

do not support another extension of the listings for antibiotics (oxytetracycline –referred to as 

tetracycline– and streptomycin) in apple and pear production. This position is based on the analysis 

that antibiotics for fire blight fail the three NOSB review criteria for materials used in organic 

production—(i) environmental and health impacts, (ii) compatibility with organic principles, and (iii) 

essentiality.

Basis for Urgent Action to Remove Antibiotics from Organic Production

There are several principal understandings that form the foundation in science and law for acting to 

remove antibiotics from organic apple and pear production in an urgent manner:

i. Tetracycline is an antibiotic considered by the World Health Organization to be of critical 

importance to human medicine.1

ii. Tetracycline is used in a way—broadcast spray on trees—that exposes bacteria in the orchard, 

particularly in the soil, to the antibiotic.2

iii. Current science shows that environmental exposure to antibiotic use in the environment is the 

major cause of development and spread of antibiotic resistance in human pathogens.3

iv. The spread of antibiotic resistance does not require contact between the antibiotic and human 

pathogens because the major means of spreading antibiotic resistance is through the transfer 

of genes between different bacteria.4
vi. Uses resulting in low residues (subtherapeutic or subinhibitory levels) can create a high health 

risk.5

vii. Tetracycline resistance is evident and expected to grow if urgent use precaution is not 

exercised.6

viii. Organic National List standards require adherence to practices and inputs that ensure, 

“Production practices implemented in accordance with this subpart must maintain or improve 

the natural resources of the operation, including soil and water quality.” (7 CFR §205.200)

NOSB Review Criteria

I. Environmental and Health Effects.

Finding: Antibiotic use in organic agriculture —in both animal and plant production— contributes to

the spread of antibiotic resistance in human pathogens, while infectious disease are a critical human 

health issue increasingly uncontrolled. Organic standards are intended, by statute and rulemaking, to 

lead in the adoption of practices that reverse threats. Several hazards associated with the use of 

antibiotics in fruit production have been documented in technical reviews. 

Summary

Agricultural use of antibiotics—including the spraying of tetracycline in orchards—increases the 

proportion of antibiotic resistant bacteria through the well-known mechanisms of selection and 

horizontal gene transfer. 7 This is affirmed in standard scientific texts and is part of the extensive 

record of NOSB proceedings,

8 which has supported extensive efforts and votes by the NOSB to end 

the use of antibiotics in organic agriculture. The mechanism of antibiotic resistance –the use of 

antibiotic anywhere increases the proportion of antibiotic resistant bacteria everywhere– is a fact wellknown to all microbiologists and has been crucial to the development of strategies to reduce antibiotic

resistance in bacteria that produce human disease.9 Tetracycline and streptomycin are both 

considered “critically important antimicrobials”10 and according to federal guidance, the risk to human 

health from their use is “high.”11

Tetracycline Resistance

Resistance to an antimicrobial agent such as tetracycline is promoted when microbes (in this case, 

bacteria) are exposed to an antimicrobial agent.12 When bacteria are exposed to tetracycline, two 

things happen: (1) the bacteria that are susceptible to tetracycline are killed, while those not 

susceptible survive,13 and (2) conjugation with other bacteria increases.14 This conjugation is a 

sharing of genetic material known as “horizontal gene transfer,” and it does not need to be between 

related bacteria.15 It can be between an innocuous soil bacterium and Escherichia coli (E-coli), for 

example.

16 Those bacteria receiving genes through conjugation may, in turn, share those genes with 

other bacteria, including human pathogens not present in the orchard.17

Therefore, spraying tetracycline in an orchard will increase the proportion of bacteria that are resistant 

to tetracycline, and increase the likelihood that human pathogens –which may not be in direct contact 

with tetracycline, but may be in contact with bacteria that were in direct contact with tetracycline –will 

end up with genes for tetracycline resistance. This is why the primary strategy for maintaining the 

effectiveness of antibiotics is to eliminate all non-therapeutic use.18

This is not a theoretical issue or a problem of scientific uncertainty. The consequences of spreading 

genes for resistance to tetracycline are considered severe by the World Health Organization (WHO). 

WHO has classified tetracycline as a “critically important antimicrobial” because it meets two criteria:

(1) it is used as the sole therapy or one of few alternatives to treat serious human disease (limited 

therapy for infections due to Brucella, Chlamydia spp. and Rickettsia spp.), and (2) it is used to treat 
diseases caused either by organisms that may be transmitted via non-human sources or by 

organisms that may acquire resistance genes from non-human sources (transmission of Brucella spp. 

from non-human sources). 19

Although the promotion of resistance to tetracycline in human pathogens does not require direct 

contact between those pathogens and the sprayed tetracycline in the orchard, there is evidence that 

such direct contact does occur. First of all, tetracycline may be taken up by plants, so that pathogens 

may be exposed when a person consumes the fruit.20 Second, there is an EPA food residue 

tolerance for tetracycline on the fruit, supported by field studies that found residues on fruit after 

harvest--which is another way for pathogens in a person to be exposed to tetracycline.21 Finally, 

tetracycline maintains its antibiotic activity as it is adsorbed to soil particles and later released, 

allowing direct exposure to tetracycline through soil in air, water, or on fruit.22 Workers, of course, are 

at higher risk of direct exposure.

23

Other Impacts on Human Health

The major impact on human health from tetracycline use is the increase in the pool of antibiotic 

resistant bacteria that can lead to resistance in human pathogens.24 However, other health effects are 

associated with exposure to tetracycline, such as developmental toxicity, and full formulations applied 

to orchards, which contain the known human carcinogen crystalline silica.25

Environmental Contamination and Ecological Impacts

The 2006 TR (TR1) lists a number of substances that may be released in the manufacture of 

tetracycline, including solvents, detergents, disinfectants, and oxides of nitrogen and sulfur.26

Quoting from the 2011 TR (TR2),

“Thiele-Bruhn (2003) reported that, in general, the effects of an antibiotic on soil organisms are 

essentially influenced by the bioavailability of the antibiotic, which depends on soil properties, 

availability of nutrients, and presence of root exudates. Tetracyclines exhibit strong adsorption to 

soil components such as clay and organic matter and form strong bonds with metals in the soil. 

These interactions limit the bioavailability of tetracyclines to microorganisms in the soil. (Lui et al., 

2009) Tetracycline can persist in soil for long periods of time without showing antimicrobial 

activity, and high concentrations can be achieved. (Popowska et al., 2010) Upon later release 

from soil components, it can exhibit antimicrobial activity. Factors that may result in a release of 

tetracycline from the soil include changes in organic material composition of the soil, shifts in 

microorganism populations, or changes in soil pH (Aga et al., 2005).”27 The TR also mentions 

reductions in fungi, fungal/bacteria biomass, rate of soil nitrification, nodulation of legumes, length 

of fungal hyphae of mycorrhizal fungi, and bacterial diversity.28 The TR cites a study that found no 

direct effects on three species of soil fauna, but “the authors noted that it is not possible to exclude 

the possibility of indirect effects on soil fauna caused by changes in the microbial community 

following application of oxytetracycline.”29

Key Elements of Scientific Understanding

The concerns about the human health impacts of tetracycline use are based on an understanding of 

the mechanisms by which antibiotic resistance develops and spreads and is directly associated with 

antibiotic resistance. In this context, the NOSB assesses whether an allowed material in organic 

production is contributing to an adverse impact even though it may be permitted under statutes other 

than the Organic Foods Production Act (OFPA). The standard of protection in OFPA and its 

overriding commitment to sustainability and improvement of the environment means that NOSB 

decisions must seek to exceed risk minimization standards of other statutes by looking to eliminate 

dependencies on practices and inputs that cause harm. This is captured in 7 CFR 205.200, 
“Production practices implemented in accordance with this subpart must maintain or improve the 

natural resources of the operation, including soil and water quality.” Thus, it is the intent, spirit, and 

letter of OFPA that puts organic systems at the forefront of rejecting practices that are not sustainable 

and puts us on a path detrimental to the environment and health. 

(i) Horizontal gene transfer and the American Academy of Microbiology, 2009.30 The American 

Academy of Microbiology (AAM) report, cited above in the pro-extension majority position discussion, 

must be read in full to glean a complete understanding of its position and urging that antibiotic 

resistance be treated as an urgent matter to prevent the spread of resistance in the environment and 

preserve the efficacy of antibiotics for human therapeutic use. Therefore the elements of the report 

are cited here:

• “If science and medicine cannot win a war against antibiotic resistance, what CAN be done? 

We have to find a way to co-exist with resistance. To minimize the loss of life, we can develop 

strategies to prevent new resistance from spreading and, where resistance already exists, 

identify the strains we need to protect against, find ways to treat resistant infections effectively 

in patients, and manage reservoirs of antibiotic resistant strains in the environment. Preventing 

development of new forms of resistance should rely, in part, on prudent use of antibiotics with 

an eye to the ecologies of pathogens and other microorganisms.”31 (pp.5-6)

• “It is mandatory to prevent the needless use of antibiotics...” (p.2)

• “Horizontal gene transfer, in which genetic information is passed between microbes, allows 

resistance determinants to spread within harmless environmental or commensal 

microorganisms and pathogens, thus creating a reservoir of resistance.” (p.1)

• “Horizontal gene transfer—the movement of genetic material from one organism to another—is 

the primary mechanism by which bacteria acquire antibiotic resistance. Antibiotics promote this 

genetic exchange by inducing the transfer of conjugative elements.” (p.8)

• “[A]ntibiotics always select naturally resistant bacteria and the strains which have acquired 

resistance...” (p.3)

• “The rate of antibiotic resistance emergence is related to all uses of these drugs, not just 

misuse...” (p.4)

• “Most organisms can be sources of resistance genes, but selection for antibiotic resistance 

most often takes place in non-pathogenic microorganisms, since they comprise the vast 

majority of the microbial world.” (p.5)

• “Developing resistance to antibiotics increases the cache of genes available to microorganisms 

and impacts many other genes as well, thereby contributing to the evolutionary possibilities 

available to them. Once a microorganism derives a genetic tool for resistance, it can pass that 

gene on to its progeny by clonal replication or to other microbes through horizontal gene 

transfer...” (p.5)

• “Selection for antibiotic resistance takes place anywhere an antibiotic is present: in the skin, 

gut, and other areas of the bodies of humans and animals and in the environment...” (p.7) 

(ii) Importance of low concentrations of antibiotics to resistance and other factors. While there 

are certainly many contributory factors to antibiotic resistance, such as widespread use of the 

antimicrobial triclosan (not allowed in organic systems), this factor does not minimize the critical role 

that low level concentrations of antibiotics play in enhancing resistance. 

The NOSB review process seeks to remove the hazards under assessment, recognizing that there 

may be other hazards as well, many outside the control of the board. While multiple factors may 

contribute to the development of resistance, the NOSB considers the various factors individually 

under the National List review process and assesses whether they contribute to harm individually. 
Additionally, the standards of material review require an assessment of harm associated with its 

manufacture, use, and disposal.

In this regard, AAM says the following:

• The use of sub-inhibitory (or sub-MIC) concentrations of antibiotics plays several important 

roles in the development of resistance. Like low concentrations of biocides (see Anti-Infective 

Strategies and Antimicrobials, above), low concentrations of antibiotics could enrich for 

resistance genes in a population while having little effect on overall mortality.”32

• “The tendency to mutate also increases upon exposure to sub-inhibitory concentrations of 

antibiotics. Pathogens can initiate an SOS response (a DNA repair pathway) when subjected 

to low concentrations of antibiotics like quinolones, which affect DNA synthesis. This may 

make them more prone to develop resistance in the future. Low concentrations of antibiotics

can also select for strains that increase expression of their existing resistance genes, further 

enhancing their resistance.33

(iii) Consideration of EPA findings. While regulatory agencies, such as EPA, register materials 

permitted by National List criteria, the standard by which EPA registers materials that are used in 

chemical-intensive agricultural production do not necessarily meet the standards of OFPA. EPA has 

registered tetracycline in fruit production and its ongoing review through its reregistration process 

(with timelines subject to change) cannot be the basis for delaying NOSB action based on the board’s 

statutory mandated technical review and assessment process. Nor can the NOSB rely on judgments 

that EPA makes under other statutory standards, including “no unreasonable adverse effects” or 

“reasonable certainty of no harm,” both governed by risk assessments. Therefore, EPA’s pesticide 

registration of tetracycline (2008) and open docket until June 2014, with an expected completion date 

of September 2014, does not necessarily add additional information beyond the Technical Review 

and cannot delay action under OFPA.

(iv) Higher exposure to tetracycline in therapeutic context. A higher use rate of tetracycline in a 

therapeutic context does not justify its allowance in organic agricultural production systems that seek 

to break the cycle of dependency on inputs and practices known to have deleterious effects on health 

and the environment. The fact that typical pharmaceutical exposures to humans are 50,000 to 

200,000 times greater than the theoretical dietary exposure34 does not justify an acceptable relative 

risk standard by which toxic inputs are allowed in organic production. If it were, reduced uses of 

virtually all hazardous synthetics would be allowed in organic production, based on the assessment 

that less is used than in chemical-intensive agriculture. Of course, that analysis does not justify the 

use of National List materials. 

Again, as explained above, the issue with respect to antibiotic resistance is not only direct human 

exposure to tetracycline, but the exposure of bacteria to tetracycline in the environment.35 And, as 

explained above, subinhibitory doses lead to increased antibiotic resistance.

(v) Resistance associated with orchard use has been found.

The pro-extension majority position, citing Schnabel and Jones (1999), points out that, “In orchards 

treated with antibiotics, only 5% of the bacteria isolated from flowers or leaves was resistant to 

oxytetracycline (10 μg/ml).” Even if this were the only finding in the study, it would be a significant 

finding, establishing the resistance mechanism and the threat that it presents. However, the authors 

also found higher levels of tetracycline resistance in the orchard that had a history of five years use of 

tetracycline before the experiment. In addition, to become problematic, resistance associated with 

tetracycline use in apple and pear production does not have to start with the fire blight bacterium 

becoming resistant. There are many bacteria in an orchard environment, including those resident in 
orchard workers, which can contribute to the spread of resistance. See discussion of AAM 2009 

above.

(vi) Laboratory studies provide useful data in conjunction with field studies, show tetracycline 

persistence for “long periods”36 . . .upon later release from soil components.”37 The extension 

proponents have criticized the TR’s treatment of individual studies in the section dealing with the 

persistence of tetracycline in soils. The complete text from the TR is helpful in understanding both the 

laboratory and field data: 

Although oxytetracycline, as an antibiotic, is toxic to some microorganisms in the soil, it is already 

present in soil due to production by naturally occurring bacteria. Thiele-Bruhn (2003) reported that, 

in general, the effects of an antibiotic on soil organisms are essentially influenced by the 

bioavailability of the antibiotic, which depends on soil properties, availability of nutrients, and 

presence of root exudates. Tetracyclines exhibit strong adsorption to soil components such as 

clay and organic matter and form strong bonds with metals in the soil. These interactions limit the 

bioavailability of tetracyclines to microorganisms in the soil (Lui et al., 2009). Tetracycline can 

persist in soil for long periods of time without showing antimicrobial activity, and high 

concentrations can be achieved (Popowska et al., 2010). Upon later release from soil 

components, it can exhibit antimicrobial activity. Factors that may result in a release of tetracycline 

from the soil include changes in organic material composition of the soil, shifts in microorganism 

populations, or changes in soil pH.

38 (Aga et al., 2005)

Laboratory studies can be helpful, especially in the context of field studies. See 2011 TR lines 502-

511: 

Popowska et al. (2010) demonstrated in a laboratory experiment that the presence of tetracycline 

in three different types of soils affected the ecological balance in the soil, causing the elimination 

of some bacterial populations. In this study, varying concentrations of tetracycline (1 – 9 ppm) 

were added to three different soil types in a laboratory setting: forest soil from a pine forest, fertile 

arable agricultural soil, and garden compost. The soils were then incubated for 14 days. The 

authors found that 2 ppm and higher concentrations of tetracycline caused a significant reduction 

in bacterial count and many bacterial species were eliminated from the soils. The eliminated 

species were described as beneficial bacteria involved in various metabolic processes, 

mineralization of organic compounds, degradation of toxic compounds, or creating soil structure. 

This study also isolated from the soils many strains of bacteria demonstrating resistance to 

tetracycline, including opportunistic pathogens of humans and/or animals.

(vii) Tetracycline has been shown to be taken up by a range of plants, both annual and 

perennial, and residuals are found in or on fruit. Kong et al. found the uptake of oxytetracycline by 

alfalfa, a perennial plant.39 “In an energy-dependent process,” Sinha et al. showed that leafhoppers 

feeding on plants grown in a medium treated with tetracycline also absorbed tetracycline from the 

plants.40 Nevertheless, there is agreement that tetracycline residues are found, albeit at low levels, in 

or on the treated fruit. According to the 2011 TR, “The current tolerance (maximum residue limit) for 

oxytetracycline on or in apples and pears is 0.35 ppm.”41

(viii) The linkage of agricultural use to antibiotic resistance is identified by FDA, absent direct 

exposure to the use pattern. Horizontal gene transfer is the central issue of concern relative to 

tetracycline use in apple and pear production and antibiotic resistance in humans. As stated earlier, 

tetracycline is considered a “critically important antimicrobial” by the World Health Organization.42

FDA’s Guidance 152 for evaluating the impact of animal drugs on human health considers the risk to 

human health to be “high” when an antibiotic is “critically important” even if the probability that the use 
of the antimicrobial will result in the emergence or selection of resistant bacteria is low and the 

probability of direct exposure to humans is low.43

Nevertheless, human beings can be found in orchards, and humans carry human pathogens. 

However, the presence or absence of human pathogens in orchards is not the prime consideration 

since the primary mechanism of the spread of antibiotic resistance is horizontal gene transfer, and the 

primary site of development of antibiotic resistance is the “environment.”44

There is no need for contact with a human or animal pathogen in order for the resistance genes to 

move out of the orchard environment. As long as the bacteria in the orchard are exposed to 

tetracycline, the selection for resistance will continue. Those bacteria may move out of the orchard in 

dust on fruit, airborne dust, dirt attached to workers’ shoes, or in many other ways. O’Brien (2002) 

says, “The abundance of E. coli implicates them as the likely predominant vehicles for the spread of 

resistance genes and vectors, as opposed to the spread of infection, between the bacterial 

populations of animals and humans...”45

(ix) The finding of resistant bacterial in soils is troubling. The focus of mechanism of antibiotic 

resistance is necessarily focused on the huge number of bacteria in the soil, even though there may 

be some research showing short tetracycline activity on plant tissue. With a focus on soil tests, such 

as those conducted by Popowska, it was found that, “Bacteria with the highest MICs [minimum 

inhibitory concentrations] were detected in manure-amended soils or soils from agricultural systems 

with a history of antibiotic use.”46 MICs are the indicator that is used to confirm antibiotic resistance. 

Meanwhile, as indicated in the scientific literature cited in this section, a finding of resistant bacteria in 

the phylosphere is not required for resistant genes to have adverse impact on human health. And, the 

existence of naturally occurring tetracycline does not address the effect of additional applied 

tetracycline and the biological impact that it has on the bacterial resistance to antibiotics. In fact, the 

fire blight organism is not necessarily the first to develop resistance. 

II. The use of antibiotics in organic production is incompatible with organic principles.47

Rather than relying on practices central to organic production —such as the choice of resistant 

cultivars and rootstocks48— the antibiotic-dependent system relies on synthetic off-farm inputs.49 The 

use of antibiotics to control fire blight is not sustainable50 and does not promote the long-term viability 

of organic farm operations because resistance to antibiotics will ultimately develop.51 This has already 

been experienced with streptomycin resistance to fire blight in the northwest.52 The use of antibiotics 

in organic fruit production is inconsistent with the prohibition against antibiotics in organic livestock 

production.53 It is inconsistent with organic standards in the European Union and Canada.54 The use 

of antibiotics in organic fruit production does not satisfy consumer expectations regarding the 

authenticity and integrity of organic products.55 As reported in “Organic pome and cherry production 

and marketing issues: Past, present and future,” and presented to IFOAM, “Over the last ten years, 

the Hartman Group (Bellevue, Washington, USA) has studied changes in consumer attitudes, 

backgrounds, and buying characteristics related to the organic market. The Hartman Group surveyed 

about two thousand household consumers across four regions of the USA. They found that the 

‘traditional’ properties suggested by ‘organic’ were no longer the same properties held by the new 

organic consumer. The survey indicated that traditional properties such as ‘locally-grown,’ Fair Trade, 

‘tastes better,’ and sustainable production ranked at the bottom. The new organic consumers made it 

clear that they want, plain and simple, a product centered around the ‘absence of all health concerns,’ 

and the absence of pesticides, growth hormones, GMO’s, antibiotics, and BSE.”56

The process surrounding antibiotics since the beginning of the National Organic Program has 

consisted of repeated acknowledgement of the public health hazard, accompanied by warnings that 

the tetracycline and streptomycin listings for apple and pear production were phasing out “the next 
time.”57 Each time, the use of these materials has been extended with great and increasing 

reluctance. While the sunset and expiration process has been used as a way of injecting continuous 

improvement into the organic systems approach to agricultural production and handling, the OFPA 

process requires that substances meet the three criteria identified at the beginning of this section —(i) 

environmental and health impacts, (ii) compatibility with organic principles, and (iii) essentiality58 The 

OFPA standards require an assessment distinct from pesticide registration process under the Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA) and require the prohibition of inputs that cause 

adverse health and environmental effects, even in the face of production practices that are reliant on 

the material. 

III. The use of antibiotics in organic fruit production is not essential.

Like most challenges in organic production systems, with fire blight there is no one material and no 

one practice that will eliminate the problem. Fire blight must be met with a truly organic systems 

approach.

With regard to the “essentiality” of tetracycline, not all organic apple and pear growers depend on 

antibiotics. In fact, there is a sizeable proportion of growers of both apples and pears who do not use 

antibiotics. However, many say that large scale, commercial, organic apple and pear production 

would end without tetracycline. In an organic market where consumers expect no antibiotic use, it is 

no small point that after years of NOSB debate and votes on discontinuing antibiotic use there is an 

expectation that the transition to less susceptible varieties and alternative practices would take place 

by the October 2014 expiration date adopted by the NOSB in 2011. 

At the April 2011 meeting of the NOSB in Seattle, Katherine Withey of the Washington State 

Department of Agriculture’s Organic Food Program said in a statement that, “In 2010 WSDA certified 

719 producers. Of these producers, 361 were certified for apples and/or pears, and of these 361 

producers 136 [38%] used tetracycline and 34 [9%] have used streptomycin.”59 Thus, it appears that 

a minority of apple and pear producers rely on these antibiotics. As of March 10, 2011, there were 96 

businesses certified as EU-compliant organic producers of apples and/or pears in the state of 

Washington alone, representing about one third of the state’s organic apple and one fourth of the 

state’s organic pear production.60 EU-compliant organic apple and pear growers cannot use 

antibiotics, and face a three-year ban from selling in the EU if they do. Instead, these growers rely on 

a number of other practices, allowing them to avoid fire blight damage to susceptible varieties:61

• Balancing nutrients and avoiding over-application of nitrogen fertilizers, especially on 

susceptible varieties of apples or pears;

• Avoidance of over-pruning in the dormant season;

• Use of pre-bloom foliar nutrient sprays even though there is no foliage;

• Use of copper materials on the trees between delayed dormant and tight cluster sages as 

preventive measures against overwintering FB; 

• Use of lime sulfur during bloom to thin apples; and, 

• Use of Serenade MAX (in the future, perhaps Blossom Protect) post-bloom and at petal-fall, 

with good spray coverage.

With some differences for pears:

• For the Bosc, use of low levels of copper only sprayed foliar during bloom and infection 

periods;
• For pear varieties Bartlett and Anjou which are subject to skin russetting, use of antagonistic 

bacterial products during bloom, followed by Serenade MAX or Blossom Protect at petal-fall; 

and,

• Copper and Lime Sulfur with oil.

In addition, Steiner’s observations offer insight into how changes in the orchard environment62 have 

contributed to epidemics of fire blight.63 In response, the following is suggested:

• Increase species diversity;

• Decrease tree density;

• Use resistant cultivars and rootstocks;

• Plant a variety of cultivars on a variety of rootstocks.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? 

1. Impact on Humans and Environment ☒Yes x 1

No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes x No ☐ N/A

3. Compatibility & Consistency ☒ Yes x No ☐ N/A

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No ☒ N/A

as Organic (only for § 205.606)

Substance Fails Criteria Category:[ ]Comments:

Proposed Annotation (if any):

Basis for annotation:☐To meet criteria above☐Other regulatory criteria ☐Citation 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

Classification Motion: N/A

Motion by: Seconded by: 

Yes: No: Absent: Abstain: Recuse:

Listing Motion: 

The Crops Sub-Committee recommends amending the listing for tetracycline to remove the 

expiration date of October 21, 2014 and add the following annotation: 

§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, 2016. 

Motion by: Nick Maravell Seconded by: Harold Austin

Yes: 5 No: 3 Absent: 0 Abstain: 0 Recuse: 0 

Resolution:

 1 “No” check marks indicate minority viewpoint.
The National Organic Standards Board is committed to the phase out of this material. The board 

urges growers and certifiers between now and the 2016 expiration date to encourage an annual 

increase in the extent and/or number of alternative practices that are trialed for controlling fire 

blight. In addition, the board strongly supports increased support for the research into these 

alternative practices and materials.

Motion by: Nick Maravell Seconded by: Zea Sonnabend

Yes: 7 No: 0 Absent: 1 Abstain: 0 Recuse: 0

Crops ☒ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic x Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

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: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman Subcommittee Chair February 11, 2013

NOSB Evaluation Criteria for Substances Added To the National List

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

Question Yes No N/A

1 Documentation(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 x [Majority Position] Line 397 (April1, 2011 TR) states no 
environmental 

contamination 

during manufacture, 

use, misuse, or 

disposal? [§6518 

m.3]

current information can be found on possible 

contamination from the manufacture of agricultural 

oxytetracycline products. Lines 398-412 does state that 

the potential could be there because of the solvents used 

in the fermentation process. Lines 412-414 state that if 

the manufacturers comply with the applicable air and 

water regulations, it is unlikely that environmental 

contamination will result from fermenting processes.

See above – if the label is followed and all applicable air 

and water regulations followed there should be no 

environmental contamination, other than from misuse. In 

the April 2011 Checklist it mentions “treated plants exude 

tetracycline”, the petitioner rebuts this stating that there is 

no data that they could find that shows apple and pear 

trees exude tetracycline. WSHA (the petitioner) states that 

scientific evidence supports the understanding that 

tetracycline does not freely translocate within an apple or 

pear tree, nor is it exuded from plants2. It is the majority 

opinion that the papers cited by the minority do not 

actually support these claims.

[Minority Position] WSHA does not actually present any 

citations to support their claim that tetracycline is not 

translocated in or exuded by plants.

Translocation of oxytetracycline is occurring as sprayed 

material on blossom ends up in fruit. See U.S. 

Environmental Protection Agency. 2005. Oxytetracycline. 

Section 3 Use on Apples. Summary of Analytical 

Chemistry and Residue Data. HED Records Center 

Series 361 Science Reviews, File R104981. Washington, 

DC.

.http://www.epa.gov/pesticides/chem_search/cleared_revi

ews/csr_PC-006304_3-Jan-05_a.pdf “Oxytetracycline 

tolerances are currently established on peaches and 

pears at 0.35 ppm in terms of oxytetracycline, only. A 

tolerance on apple is proposed, also at 0.35 ppm.TR13

lines 149-164; TR2 397-426. This is reinforced by label on 

another oxytetracycline product, Mycoject, while only 

registered for ornamental, indicates on its label that it is 

applied by injection and acts by translocation. See 

Mycoject label, 

http://www.mauget.com/ProductLabels/AnitiboticLabels/M

ycoject.pdf

TR1 (lines 149-164); TR2 (lines 397-426): Manufacture 

may result in discharges of solvents, detergents, 

 2 Washington State Horticultural Association, 2011. Comment on the re-listing of tetracycline to docket AMS-NOP-11-

0014, page 3. 3 TR1 is TR dated January 27, 2006.
disinfectants.

Kumar et al, 2005; Kong et al, 2006; Sinha and Peterson, 

1972; Daniels, 1982:4 Treated plants may contain and 

exude tetracycline. 

TR25 291-294: “Once released into the soil, 

oxytetracycline is expected to become strongly adsorbed 

to soil particles and have moderate to no mobility. (Kumar 

et al., 2005; HSDB, 2006) This means it can remain in soil 

for a long time following treatment. Furthermore, it is not 

likely to leach below the surface soil (Aga et al., 2005);

however it can spread by surface run-off of sediment.”

TR2 322-324: “Chander et al. (2005) demonstrated that 

even though tetracycline was tightly adsorbed to clay 

particles in soil, it was still biologically active” following a 

24-hour incubation period.

3. Is the substance 

harmful to the 

environment and 

biodiversity?

[§6517c(1)(A)(i);65

17(c)(2)(A)i] 

x x [Majority Position] April 29, 2011 Checklist refers to a 

report by Thiele-Bruhn and Beck, 2005 on the effects of 

tetracycline in soil microbial activity. This report is appears 

to refer to two soil groups representative of European 

soils. This report does not reflect typical soils or types of 

soil amendments found in the U.S6, nor does it reflect the 

use pattern for this allowed substance as it is listed.

[Minority Position] See complete reference to TR2 (lines 

296-307) that cites scientific literature on limited to no 

oxytetracyline degradation in U.S. soils: “[T]he extent and 

kinetics of antibiotic degradation in soil is highly 

dependent on temperature, soil type, and antibiotic 

adsorption to soil (Thiele-Bruhn, 2003). One study 

reported no degradation of oxytetracycline in a soil and 

manure sample after 180 days (Thiele-Bruhn, 2003). In a 

field study with silt loam soil, the measured amount of 

oxytetracycline in the soil declined by 50% in three weeks 

following application of manure with oxytetracycline, 

however the amount of total tetracyclines did not 

significantly decline after 5 months (Aga et al., 2005). 

Another study showed that oxytetracyline residues were 

present in agricultural soil 10 months after fertilization with 

manure containing oxytetracycline (Cengiz et al., 2010). 

Wang and Yates (2008) found the half-life of 

 4 K. Kumar, S.C. Gupta, Y. Chander, and C.J. Rosen, 2005. Antibiotic Uptake by Plants from Soil Fertilized with Animal 

Manure. J. Environ. Qual. 34:2082–2085 (2005).

W.D. Kong, Y.G. Zhu,

,, Y.C. Liang, J. Zhang, F.A. Smith, and M. Yang, 2007. Uptake of oxytetracycline and its 

phytotoxicity to alfalfa (Medicago sativa L.). Environmental Pollution, Volume 147, Issue 1, May 2007, Pages 187-193.

RC Sinha and EA Peterson, 1972. Uptake and persistence of oxytetracycline in aster plants and vector leafhoppers in 

relation to inhibition of clover phyllody agent, Phytopathology 62: 50-56.

MJ Daniels, 1982. Editorial: Possible effects of antibiotic therapy in plants. Reviews of Infectious Diseases 4 (Supp): 167-

170.

5 TR2 is TR dated April 1, 2011.

6 Washington State Horticultural Association, 2011. Comment on the re-listing of tetracycline to docket AMS-NOP-11-

0014, page 4.
oxytetracycline to be 33 days in manure-amended soil 

and 56 days in non-amended soil. Yang et al. (2009) 

reported half-lives for oxytetracycline between 29 and 56 

days for non-sterile treatments and 99 to 120 days for 

sterile treatments (aerobic conditions), and between 43 

and 62 days in the non-sterile soil and 69 to 104 days in 

sterile soil (anaerobic conditions).”

Thiele-Bruhn and Beck, 2005:

7 “The antibiotics 

significantly (p < 0.05) reduced numbers of soil bacteria, 

resulting in dose related shifts in the fungal: bacterial 

ratio, which increased during 14 d, as determined from 

analysis of ergosterol and EC. It was concluded

that pharmaceutical antibiotics can exert a temporary 

selective pressure on soil microorganisms even at 

environmentally

relevant concentrations.”

Aminov, 2011:

8 “There is a substantial body of evidence 

suggesting that the sub- inhibitory concentrations of 

antibiotics may significantly increase the frequency of 

horizontal transfer of many types of MGEs [mobile genetic 

elements].”

See #6 below.

TR2 322-324: “Chander et al. (2005) demonstrated that 

even though tetracycline was tightly adsorbed to clay 

particles in soil, it was still biologically active” following a 

24-hour incubation period. There is a concern that the 

persistence of oxytetracycline residues in the environment 

may contribute to the development of bacterial resistance 

to oxytetracycline and other tetracyclines (Arikan et al., 

2007).”

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 [Majority Position] TR 2 (page 9 lines 432-434) states 

that there is no information available to assess whether 

spray applications of tetracycline will cause chemical 

reactions or interaction with other materials used in 

organic crop production. 

[Minority Position] Burgos et al, 2003:

9 Bacteria with 

multiple resistances may result from use of 

oxytetracycline and manure treated with other antibiotics.

6. Are there adverse x [Majority Position] TR2 (lines 442-453): it was stated 

 7 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

8 Rustam I. Aminov, 2011. Horizontal gene exchange in environmental microbiota, Front Microbiol. 2011; 2: 158. 9 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.
biological and 

chemical 

interactions in agroecosystem? [§6518 

m.5]

that there were no available information on the 

interactions in the agro-ecosystems following the use of 

oxytetracycline specifically for foliar use to control fire 

blight in apples and pears. There are studies where 

tetracycline has been applied directly to the soil and 

usually are related to manure applications where 

tetracycline treatments of the animals have been used, or 

where it has been included in feed stocks.

[Minority Position] Thiele-Bruhn and Beck, 2005: 

Oxytetracycline shifts fungal-bacterial balance at 

environmentally relevant concentrations.TR2 469-511: 

Application of oxytetracycline changed fungal and 

bacterial composition of soils and reduced the rate of 

nitrification.

7. Are there 

detrimental 

physiological 

effects on soil 

organisms, crops, 

or livestock? [§6518 

m.5]

x [Majority Position] The TR from 2006 (Lines 210-212):

Therefore, it seems unlikely that proper use of calcium 

oxytetracycline to control fire blight in organic crop 

production would cause any adverse chemical or 

biological interactions in the agro-ecosystem. The 2011 

TR also indicates no negative interactions could be found 

in literature (2011 TR lines 432-436.

[Minority Position] TR2:” No information could be found 

on interactions in the agro-ecosystem following the use of 

oxytetracycline specifically for control of fire blight in 

apples and pears.” TR2 does present results of a number 

of laboratory studies. 

8. Is there a toxic or 

other adverse 

action of the 

material or its 

breakdown 

products?

[§6518 m.2]

x x [Majority Position] The 2011 Checklist and the petitioner 

have both combined answers and response to this 

question (8) and checklist question 10, listed below. (See

additional information listed under question 10 of this 

section.)*See Checklist Discussion, Category1, Question 

8 and 9: Mode of Action, Breakdown, and Residues, in 

the Introduction Document.

[Minority Position] Mycoshield MSDS: Other Acute

Effects: Oxytetracycline may cause severe allergic 

reactions (anaphalactic shock) in sensitive individuals. 

Subchronic (Target Organ) Effects: For oxytetracycline,

gastrointestinal irritation with nausea, epigastric pain and 

burning, vomiting, abdominal pain, transitory yellowishbrown discoloration of the tongue, anorexia and diarrhea.

Blood disorders (delay in coagulation) have been 

reported. Possible hypersensitization and superinfections 

due to overgrowth of resistant organisms not affected by 

the antibiotic. Three types of renal diseases are 

associated with overexposure: Acute Non-Oliguric Renal 

Failure (individuals with pre-existing pancreatitis or fatty 

liver); Uremia (individuals with pre-existing impaired renal 

function) and Reversible Nephrotoxicity (due to outdated

or degraded tetracyclines). Inhalation of excessive 
amounts of kaolin dust may produce coughing, sneezing, 

and nasal irritation Chronic exposure to mica may cause 

persistent cough, possible difficulty in breathing. 

Carcinogenicity/chronic effects: Prolonged 

overexposure to oxytetracycline may cause effects to skin 

and digestive tract. Oxytetracycline did not cause cancer 

in laboratory animals. Long-term over-exposure to kaolin 

dust may affect lungs. The diluent as a whole is not listed 

as a carcinogen. However, it does contain crystalline 

silica (e.g. Quartz), a natural occurring component. 

Inhalation of crystalline silica may cause pulmonary 

fibrosis (silicosis). Crystalline silica has been classified by 

International Agency for Research on Cancer (IARC) as 

carcinogenic to humans (Group 1), by the US NTP as a 

known human carcinogen, and by ACGIH as a suspected 

human carcinogen (A2). Developmental Toxicity:

Adverse effects were reported in mother (severe hepatic 

damage) and fetus (retardation of skeletal development, 

discoloration of teeth, and enamel hypoplasia.)

See also #10 below.

9. Is there undesirable 

persistence or 

concentration of the 

material or 

breakdown 

products in 

environment?[§651

8 m.2]

x [Majority Position] The November 2008 

recommendation and checklist states degradation half-life 

varies from 30 days (fresh water) to 10 weeks in pond 

sediments. It is absorbed and inactivated in dry soils. The 

2011 TR (lines 535-543) states that according to EPA’s 

(RED) Pesticides Registration Eligibility Document in 

1993 that oxytetracycline products labeled and used 

according to EPA regulations will not pose unreasonable 

risks or adverse effects to the environment. Since that 

time (EPA 2006a &b) the agency noted that new 

environmental fate studies should be conducted. From the 

EPA-HQ-OPP-2008-RegReview Summary: "The 

environmental fate data currently under review, along with 

the data to be requested, are expected to address some 

of the uncertainties laid out in the 2006 oxytetracycline 

TRED regarding the potential for antibiotic resistance 

resulting from the pesticidal uses." This Re-review by EPA 

is currently underway and is scheduled to be completed in 

201410.(also TR lines 542-543) The whole subcommittee 

recognizes that EPA risk assessments are a different 

standard than the criteria for the organic regulations, but 

the majority believes the EPA information will be an 

important resource contributing to evaluating our criteria.

*See Checklist Discussion, Category 1, Questions 8 and 

9: Mode of Action, Breakdown, and Residues, in the 

Introduction Document.

[Minority Position] OFPA requires Board evaluation of

 10 United States Environmental Protection Agency. 2008. Oxytetracycline summary document registration review: initial docket 

December 2008. Docket number: EPA-HQ-OPP-2008-0686. Available at: www.regulations.gov
adverse effects to determine the acceptability of material 

listing, taking into account compatibility with organic 

practices. EPA regulates to a different standard of no 

unreasonable risks, which does not include all OFPA 

checklist criteria. In this context, the question is whether 

organic practices should be contributing to antibiotic 

resistance.

Schnabel and Jones, 199911: Resistance to 

oxytetracycline is associated with use in orchard. To 

become problematic resistance associated with 

tetracycline use in apple and pear production does not 

have to start with the fire blight bacterium becoming 

resistant.

Kumar et al, 2005; Kong et al, 2006; Sinha and Peterson, 

1972; Daniels, 1982: Tetracycline may be taken up by 

plants and appear in all tissues and in exudates.

TR2 291-294: Once released into the soil, oxytetracycline 

is expected to become strongly adsorbed to soil particles 

and have moderate to no mobility. (Kumar et al., 2005; 

HSDB, 2006) This means it can remain in soil for a long 

time following treatment. Furthermore, it is not likely to 

leach below the surface soil (Aga et al., 2005); however it 

can spread by surface run-off of sediment.

TR2 322-324: “Chander et al. (2005) demonstrated that 

even though tetracycline was tightly adsorbed to clay 

particles in soil, it was still biologically active” following a 

24-hour incubation period.

Halling-Sørensen et al, 2002:

12 Degradation products 

have same activity as parent.

TR2 463-465: Tetracycline can persist in soil for long 

periods of time without showing antimicrobial activity, and 

high concentrations can be achieved. (Popowska et al., 

2010) Upon later release from soil components, it can 

exhibit antimicrobial activity.

10. Is there any harmful 

effect on human 

health? [§6517 c 

(1)(A)(i); 6517 

c(2)(A)i; §6518 m.4]

x The 2011 TR (lines 557-559) according to EPA’s 

Tolerance Reassessment Progress and Risk 

Management Decision (TRED) for oxytetracycline there is 

reasonable certainty that no harm to any population 

subgroup will result from exposure to oxytetracycline 

(EPA, 2006b, p.4) The whole subcommittee recognizes 

that EPA risk assessment alone is not sufficient to replace 

the OFPA criteria and that other information must be 

looked at. However there is no direct evidence of negative 

human health impacts that have been proven to occur 

 11 Elise L. Schnabel and Alan L. Jones, 1999. Distribution of tetracycline resistance genes and transposons among 

phylloplane bacteria in Michigan apple orchards. Appl. Environ. Microbiol., 65, 4898–4907.

12 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.
solely from the use of oxytetracycline in apples and 

pears.13 14

*See Checklist Discussion, Category 1, and Question 10: 

Potential for Humans to build Resistance to Medical 

Tetracyclines, in the Introduction Document.

[Minority Position] Data submitted in support of EPA’s 

establishment of a tolerance for tetracycline demonstrated 

residues of tetracycline in apples.15

Levy, “Antibiotic resistance: an ecological imbalance” 

(1997) at p6”: Dietary exposure of medical concern -

“Tetracycline resistance in the faecal flora was high when 

the volunteers were eating normal, non-sterilized food for 

21 days, but dropped dramatically when the diet was 

shifted to sterilized food for 17 days.”

TR163-71, 279-293: Workers are at risk of contracting 

tetracycline-resistant disease and suffering from allergic 

reactions.

Lugo-Melchor et al, 2010:

16 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.

Levy et al, 1976:17 Workers who handle feed with 

tetracycline have tetracycline-resistant flora in their 

intestines.

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

clines 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 

 13 Stockwell, V.O., and Duffy, B. 2012. Use of antibiotics in plant agriculture. Rev. Sci. Tech. Off. Int. Epiz., 31:199-210.

14 Stockwell, V. and Granatstein, D. 2013. Lack of Evidence for Linkage of Plant Agriculture Use of Oxytetracycline to 

Antibiotic Resistance in Human Pathogens. unpublished report posted to Washington State University Tree Fruit 

Research and Education Center: http://www.tfrec.wsu.edu/pages/organic/fireblight

15 United States Environmental Protection Agency. 2005. Oxytetracycline. Section 3 Use on Apples. Summary of 

Analytical Chemistry and Residue Data. HED Records Center Series 361 Science Reviews, File R104981. Washington, 

DC. http://www.epa.gov/pesticides/chem_search/cleared_reviews/csr_PC-006304_3-Jan-05_a.pdf “Oxytetracycline 

tolerances are currently established on peaches and pears at 0.35 ppm in terms of oxytetracycline, only. A tolerance on 

apple is proposed, also at 0.35 ppm. The crop field trials were conducted from 0.5 to 11.6X the proposed seasonal rate of 

1.53 lb ai/A and from 49 to 61 days PHI as compared to the proposed PHI of 60 days. Residues were largely at the limit of 

quantitation (LOQ) of 0.013 to 0.2 ppm up to 0.252 ppm for a 1X study in Region V [MI]. Adequate storage stability data 

were presented to indicate that the residues of oxytetracycline were stable for the duration of the residue field trial 

studies.”

16 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.

17 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.
cholera, although drug-resistance is occurring, and their 

effects on overall mortality is questioned.

“Prop 65 list” 

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

405.pdf

Developmental toxin listed by the state of California. 

TR2 549-551: There is a high probability that 

oxytetracycline resistant bacteria are present in the 

environment as a consequence of pesticidal use of 

oxytetracycline which may have negative health 

consequences for humans (EPA, 2006).

The World Health Organization (WHO) has recently 

changed its categorization of tetracyclines from “highly 

important” to “critically important””18

See also #8 above.

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.

NOSB Evaluation Criteria for Substances Added To the National List

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

Question Yes No N/A1 Documentation(TAP; petition; regulatory agency; 

other)

1. Is the substance 

formulated or 

manufactured by 

a chemical 

x TR2, lines 247-277: Oxytetracycline is a naturally 

occurring compound produced by the soil bacterium 

Streptomyces rimosus. It is produced on a large scale by 

aerobic fermentation followed by isolation and purification 

 18 WHO, 2009. Report of the First Meeting of the Advisory Group on Integrated Surveillance of Antimicrobial Resistance. 

CDC, 2010. National Antibiotic Resistance Monitoring System: Enteric Bacteria-- 2010 Human Isolates Final Report.
process? [6502 

(21)]

processes. The materials as formulated may or may not 

have gone through a chemical change during the 

manufacturing process.

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 See above – question #1. The two forms of tetracycline 

current on the National List as approved are listed as 

synthetic substances.

3. Is the substance 

created by 

naturally occurring 

biological 

processes? [6502 

(21)]

x See above answers to questions #1 & 2.

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 [Majority Position] Available natural biological control 

materials have been proven to not adequately control the 

serious damage caused by the fire blight organism. 

(November 2008 recommendation/checklist) There are 

current trials being conducted on two different strains of 

yeast Aureobasidium pullulans that make up a product 

from Germany named, Blossom Protect. (2011 TR lines 

636-641) (Kunz et al., 2011)

TR2 622-725: other products include Bloomtime, Blight 

Ban A 506, Serenade Max that are listed for use in 

controlling fire blight.

In the April 29, 2011 recommendation/checklist it 

mentions that there is a natural replacement 

Pseudomonas spp. (Stockwell and Stack, 2007) 
(Phytopathology 97:244-249) The petitioner rebuts this by 

addressing the inconsistency of control from the use of 

Pseudomonas spp. for control of fire blight in “real world”

conditions. In the EPA’s Oxytetracycline TRED (pages 5 

of 15, June 2006) it states that the biological control 

agent, Blight Ban A506 (a.i. Pseudomonas flourescens

strain A506) is used to complement an antibiotic pesticide 

and it is not a replacement for antibiotics. Blight Ban is to 

be used as part of an integrated control program. Also, 

there is another product similar to Blight Ban called 

Bloomtime (Pantoea agglomerans). 

[Minority Position] Since Blossom Protect is now 

available in the U.S.,

19 it should be noted that research 

reports from Washington state show its efficacy to be 

equal to or better than that of oxytetracycline.20 Certainly, 

research on all of the known products as well as new 

ones can and should continue, but that should not 

preclude action by the NOSB.

TR2 lines 713-714: “The results are mixed for biological 

control agents in the suppression of fire blight.” 

Granatstein, 201321: Blossom Protect has given results 

equal to tetracycline

Stockwell and Stack, 2007:

22 BlightBan A506 provides 

significant control of fire blight caused by E. amylovora, 

russet caused by IAA-producing bacteria, and frost injury 

due to ice-nucleation active bacteria

Glenn et al, 2001:

23 BlightBan A506 provides significant 

control of fire blight caused by E. amylovora, russet 

caused by IAA-producing bacteria, and frost injury due to 

ice-nucleation active bacteria

8. Is the substance 

used in handling, 

not synthetic, but 

not organically 

produced?

[§6517 c 

(1)(B)(iii)]

x

9. Are there any 

alternative 

substances? 

[§6518 m.6]

x Peracetic acid is now registered for use against fire 

blight, but the TR2 (lines 747-748) says, “No information 

could be found on the efficacy of peracetic acid in control 

of fire blight.” There are other products that currently 

 19 See label at: http://westbridge.com/products-pdf-documents/BlossomProtectLabel.pdf

20 Granatstein, 2013. Fire Blight Introduction, OTA Task Force Meeting, January 21, 2013. Powerpoint slides 13-14.

21 Granatstein, D., 2013. Fire Blight Introduction, OTA Task Force Meeting, January 21, 2013. Powerpoint slides 13-14.

22 Stockwell, V. O., and Stack, J. P. 2007. Using Pseudomonas spp. for integrated biological control. Phytopathology 

97:244-249.

23 Glenn, D. M., van der Zwet, T., Puterka, G., Gundrum, P., Brown. E. 2001. Efficacy of

kaolin-based particle films to control apple diseases. Online. Plant Health Progress

doi:10.1094/PHP-2001-0823-01-RS. http://ddr.nal.usda.gov/bitstream/10113/12139/1/IND43805958.pdf
claim or have shown some control: Serenade, lime-sulfur, 

copper and the biological products. There are currently 

no stand- alone viable alternatives for reliable control of 

fire blight on apples and pears in organic 

production.(2012 Petition last paragraph page 11 of 13)

*See Checklist Discussion, Category 2 Questions 9 & 10 

for further discussion on Pears, in the Introduction 

Document.

Granatstein, 2013: Blossom Protect has shown 

comparable efficacy to oxytetracycline in recent trials.

However it has been shown to work much better in 

conjunction with a copper spray ahead of it to remove 

competing microbes from the flower before introducing 

the Blossom Protect. And the Blossom Protect does not 

give immediate results in extreme risk situations.

TR1 lines 317-330

Phytotoxicity limits usefulness of copper compounds 

currently available for use. There are a couple of new 

copper compounds currently being looked at in research 

trials that may help to remove that limitation.

10. Is there another 

practice that 

would make the 

substance 

unnecessary? 

[§6518 m.6]

x x [Majority Position] There are other practices that could 

help as part of an integrated systems approach to 

controlling fire blight that could help to reduce the 

reliance upon oxytetracycline. But, these practices would 

not replace oxytetracycline by themselves. 

The April 1, 2011 TR (lines 757-762) mentions using 

resistant varieties of apples and pears. (Koski and 

Jacobi, 2009) There is no cultivar that is completely 

immune to fire blight. There are some rootstocks

(Geneva) coming that are showing good resistance

potential, but these are still several years away from 

being commercially available. (This would also not 

address the thousands of acres of organic apples and 

pears currently in production.) This is only the rootstock 

and not the cropping or cultivar part of the tree.

Selection of soils and proper air and water drainage will 

aid in control. Pruning out cankers will help by removing 

some of the inoculum from the orchard. Fertility 

management will also help, by controlling vegetative 

growth of the tree. There are several detection models 

that are currently in use to assist in the identification of 

infection periods and their severity, as well as proper 

timing of control materials to maximize their efficacy in 

controlling fire blight. (“Fireblight Management in the 

Pacific Northwest USA”) 

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

Everything listed here would work together as part of an 

organic systems approach to fire blight control, but not as 

a stand –alone.

*See Checklist Discussion, Category 2 Questions 9 & 10 
for further discussion on Pears, in the Introduction 

Document.

[Minority Position] TR1 297-302, 335-343.

Resistant cultivars. Proper pruning, fertilization, watering, 

drainage.

Aldwinckle et al, 199824.

“Serious fire blight damage can be avoided simply by not 

planting highly susceptible scion varieties and 

rootstocks.”

“Fireblight Management in the Pacific Northwest USA” 

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

Streptomycin “is no longer adequately effective in most 

of the Pacific Northwest”

Ken Johnson25: ‘Integrated control’: ... utilizing delayed 

dormant copper sanitation ... in apples, using bloom 

thinners to further delay pathogen ‘build-up’ in flowers 

As of March 10, 2011, there were 96 businesses certified 

as EU-compliant organic producers of apples and/or 

pears in the state of Washington alone, representing 

about one third of the state’s organic apple and one 

fourth of the state’s organic pear production.26

Testimony of Katherine Withey, Washington State Dept 

of Agriculture at Seattle NOSB meeting 4/2/2011 p. 380: 

“In 2010 WSDA certified 719 producers. Of these 

producers, 361 were certified for apples and/or pears, 

and of these 361 producers 136 used tetracycline and 34 

have used streptomycin.”

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.

NOSB Evaluation Criteria for Substances Added To the National List

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

Oxytetracycline

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 [Majority Position] The substance, 

oxytetracycline is on the list of 

allowed exemptions in question 7 

below. It is derived from a non-

 24 H. Aldwinckle, J Norelli, and MT Momol, 1998. Fire blight: the search for better control. IDFTA Compact Fruit Tree, Vol. 

31, No. 4

25 Ken Johnson, 2012. Fire Blight Control in Organic Pome Fruit Systems Under the Proposed Non-antibiotic Standard. 

http://www.extension.org/pages/62448/fire-blight-control-in-organic-pome-fruit-systems-under-the-proposed-nonantibiotic-standard

26 Washington State Department of Agriculture printout, “International Organic Program—EU Compliant Operations, 

March 10, 2011.
synthetic source organism, works in a 

similar fashion to other biologically 

based control organisms and has a 

history of safe use in organic farming 

systems for more than 20 years. The 

issues surrounding the use of 

antibiotics in animal agriculture have 

not been proven to pose the same 

threats when used in plants.

[Minority Position] Ostenson, H.T. 

2010, citing Hartman Group27 study, 

which says antibiotic use is contrary 

to consumer expectations. 

Inconsistent with prohibition on 

antibiotics in livestock.

TR2 lines 226-230: Inconsistent with 

European requirements.

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

x [Majority Position] The NOSB 

recommendation concerning 

assessing consistency and 

compatibility28 lists 12 factors to be 

considered for determining this and 

the majority believes that over the 

time this has been on the National 

List, some factors have gained priority 

over others and thus acknowledges 

the need to phase the material out. 

However the majority feels that this 

needs to be done in a way that 

causes less disruption to the whole 

industry as alternatives are adopted.

[Minority Position] Increases 

likelihood of antibiotic resistance in 

pathogenic organisms.

The use of antibiotics to control fire 

blight is not sustainable29

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 x

 27Ostenson, H.T. 2010. Organic pome and cherry production and marketing issues: Past, present and future. Acta Hort. 

(ISHS) 873:137-144

28 NOSB Policy and Procedures Manual p.32.

29 NOSB Principles of Organic Production and Handling says, “Organic production and handling systems strive to achieve 

agro-ecosystems that are ecologically, socially, and economically sustainable.” AAM, 2009. p.3. “The struggle against 

antibiotic resistance is a war we will never win.”
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]

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.

NOSB Evaluation Criteria for Substances Added To the National List

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: Oxytetracycline

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

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 

x
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?

x

5. Does the industry information 

provided on material / substance 

non-availability 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

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.

References for Majority Position Discussion, General:

American Academy of Microbiology, 2009. Antibiotic Resistance: An Ecological Perspective on an 

Old Problem.http://academy.asm.org/images/stories/documents/antibioticresistance.pdf

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.

Christiano, R.S.C., Reilly C.C., Miller W.P. and Scherm H. 2010. Oxytetracycline dynamics on peach 

leaves in relation to temperature, sunlight, and simulated rain. Plant Dis., 94:1213–1218.

Duffy B., Walsh F., Pelludat C., Holliger E., Oulevet C. & Widmer F. (2011) – Environmental 

monitoring of antibiotic resistance and impact of streptomycin use on orchard bacterial 

communities. Acta Horticult., 896, 483–488.
Halling- Sorensen et al, 2002. Toxicity of tetracyclines and tetracycline degradation products to 

environmentally relevant bacteria, including selected tetracycline-resistant bacteria. Archives of 

Environmental Contamination and Toxicology 42:263-271.

Kumar, K et al, 2005, Antibiotic Uptake by Plants from Soil Fertilized with Animal Manure.J. Environ. 

Qual. 34:2082–2085 (2005). 

Larsen J, Schonheyder HC, Lester CH, Olsen SS, Porsbo LJ, Garcia-Migura L, Jensen LB, Bisgaard 

M, Hammerum AM. 2010. Porcine-origin gentamicin-resistant Enterococcus faecalis in humans, 

Denmark. Emerg Infect Dis. 16:682-684.

Liu, F., Ying, G-G., Tao, R., Zhao, J-L, Yang, J-F., Zhao, L-F. 2009. Effects of six selected antibiotics 

on plant growth and soil microbial and enzymatic activities. Environmental Pollution 157: 1636-

1642.

McManus, P. S., and Stockwell, V. O. 2001. Antibiotic Use for Plant Disease Management in the 

United States. Plant Health Progress. Available at: 

www.plantmanagementnetwork.org/pub/php/review/antibiotic/

McManus, P. S., Stockwell, V. O., Sundin, G. W., and Jones, A. L. 2002. Antibiotic use in plant 

agriculture. Annu. Rev. Phytopathol. 40: 443-465.

Mayerhofer, G., Schwaiger-Nemirova, I., Kuhn, T., Girsch, L., and Allerberger, F. 2009. Detecting 

streptomycin in apples from orchards treated for fire blight. Journal of Antimicrobial Chemotherapy 

63(5):1076 -1077.

National Organic Standards Board 2011. Final Recommendation on Tetracycline Petition. 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091701&acct=nosb

O’Brien, T.F. 2002. Emergence, Spread, and Environmental Effect of Antimicrobial Resistance: How 

Use of an Antimicrobial Anywhere Can Increase Resistance to Any Antimicrobial Anywhere Else,

Clin Infect Dis. 34 Suppl 3:S78-84

Popowska M., Rzeczycka M., Miernik A., Krawczyk-Balska A., Walsh F. & Duffy B. (2012) – Influence 

of soil use on prevalence of tetracycline, streptomycin and erythromycin resistance and associated 

resistance genes. Antimicrob. Agents Chemother., 56 (3), 1434–1443. 

Pusey P.L., Stockwell V.O. & Mazzola M. (2009). – Epiphytic bacteria and yeasts on apple blossoms 

and their potential as antagonists of Erwinia amylovora. Phytopathology, 99, 571–581.

Rezzonico F., Stockwell V.O. & Duffy B. (2009). – Plant agriculture streptomycin formulations do not 

carry antibiotic resistance genes. Antimicrob. Agents Chemother., 53, 3173–3177.

Schnabel E.L. & Jones A.L. (1999). – Distribution of tetracycline resistance genes and transposons 

among phylloplane bacteria in Michigan apple orchards. Appl. Environ. Microbiol., 65, 4898–4907.

Stockwell, V.O., Temple, T.N., Johnson, K.B. and Loper, J.E. 2008. Integrated control of fire blight 

with antagonists and oxytetracycline. Acta Hort., 793:383–390.

Stockwell, V.O., and Duffy, B. 2012. Use of antibiotics in plant agriculture. Rev. Sci. Tech. Off. Int. 

Epiz., 31:199-210.

Stockwell, V.; Granatstein, D.; and Grieshop, M. 2013. Antibiotic Residues on Plant Tissues.

unpublished report posted to Washington State University Tree Fruit Research and Education 

Center: http://www.tfrec.wsu.edu/pages/organic/fireblight 

Stockwell, V. and Granatstein, D. 2013. Lack of Evidence for Linkage of Plant Agriculture Use of 

Oxytetracycline to Antibiotic Resistance in Human Pathogens. unpublished report posted to 

Washington State University Tree Fruit Research and Education Center: 

http://www.tfrec.wsu.edu/pages/organic/fireblight

Subbiah M., Mitchell S.M., Ullman J.L. & Call D.R. (2011). – β-lactams and florfenicol antibiotics 

remain bioactive in soils while ciprofloxacin, neomycin, and tetracycline are neutralized. Appl. 

Environ. Microbiol., 77, 7255–7260.

Sundin G.W. & Bender C.L. (1996). – Dissemination of the strA-strB streptomycin resistance genes 

among commensal and pathogenic bacteria from humans, animals, and plants. Molec. Ecol., 5, 

133–143.

United States Environmental Protection Agency. 2005. Oxytetracycline. Section 3 Use on Apples. 

Summary of Analytical Chemistry and Residue Data. HED Records Center Series 361 Science 
Reviews, File R104981. Washington, DC. 

http://www.epa.gov/pesticides/chem_search/cleared_reviews/csr_PC-006304_3-Jan-05_a.pdf

United States Environmental Protection Agency. 2006a. Report of the Food Quality Protection Act 

(FQPA) tolerance reassessment progress and risk management decision (TRED) for 

oxytetracycline. Available at: www.epa.gov/oppsrrd1/REDs/oxytetracycline_tred.pdf.

United States Environmental Protection Agency. 2006b. Report of the Food Quality Protection Act 

(FQPA) tolerance reassessment progress and risk management decision (TRED) for streptomycin. 

Available at: www.epa.gov/oppsrrd1/REDs/streptomycin_tred.pdf.

United States Environmental Protection Agency. 2008. Oxytetracycline summary document 

registration review: initial docket December 2008. Docket number: EPA-HQ-OPP-2008-0686. 

Available at: www.regulations.gov.

US Department of Agriculture (USDA) 2011. Technical Report (TR) on Tetracycline (Oxytetracycline). 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090416

Walsh F., Ingenfeld A., Zampicolli M., Hilber-Bodmer M., Frey J.E. & Duffy B. (2011). – Real-time 

PCR methods for quantitative monitoring of streptomycin and tetracycline resistance genes in 

agricultural ecosystems. J. Microbiol. Meth., 86, 150–155.

Washington State Horticultural Association, et al, 2012. Petition to National Organic Standards Board 

(NOSB) for Removal of the Expiration Date for Tetracycline. 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5098930

(includes an appendix with their comments to the NOSB in April, 2011).

Wright, G.D. 2010. Antibiotic resistance in the environment: a link to the clinic? Curr. Opin. Microbiol.

13:589–594.

Yashiro E, McManus PS. 2012. Effect of streptomycin treatment on bacterial community structure in 

the apple phyllosphere. PLoS ONE 7(5): e37131. doi:10.1371/journal.pone.0037131

References for Pears:

Adaskaveg, J.E. and Gubler, W.D. 2010. Evaluation of new bactericides for control of fire blight of 

pears caused by Erwinia amylovora. Annual Report for California Pear Advisory Board. 

http://www.calpear.com/_pdf/research-reports/JEA%20Fireblight.pdf.

Granatstein, D., Smith, T. and Peck, G. 2011. The Role of Tree Genetics in Controlling Fire Blight in 

Apples and Pears. http://www.tfrec.wsu.edu/pdfs/P2396.pdf

Smith, T.J. 2011. Improving the management of two critical pome fruit diseases. Final Project Report, 

WTFRC Project Number cp-09-904.

Keil, H.L. and Wilson, R.A. 1962. Six years of testing streptomycin-oxytetracycline for control of fire 

blight on Bartlett pear. Pl. Dis. Reptr. 46:397-400.

Holtz, B.A., Teviotdale,B., and Turini, T. 1999. Comparison of models to predict the occurrence of fire 

blight in the San Joaquin valley of California, Acta, Hort. 489:437-444.

Holtz, B.A., Hoffman, E.W. and Teviotdale, B.L. 2002. Predicting the occurrence of fire blight in the 

San Joaquin valley of California. Acta Hort. 590:167-174.

Zoller, B. G. 2000. Fire blight control experiences in the Sacramento Valley of California 1973 – 1999. 

Proc. WOPDMC 74:103-104. http://entomology.tfrec.wsu.edu/wopdmc/2000PDF/8-

TREE%20FRUIT/Tree%20Fruit%2000-1.pdf

Zoller, B. 2011. Use of Streptomycin and Oxytetracycline for Fire Blight Management in Organic Pear 

Production in California.http://www.tfrec.wsu.edu/pdfs/P2399.pdf

 

Endnotes for Minority Position
 1 WHO, 2009. Critically Important Antimicrobials for Human Medicine, 

http://www.who.int/foodsafety/foodborne_disease/CIA_2nd_rev_2009.pdf See Table 1.

2 Tetracycline TR, April 1, 2011. Lines 291-326. Mycoshield label http://www.cdms.net/ldat/ld246008.pdf

3 American Academy of Microbiology, 2009. Antibiotic Resistance: An Ecological Perspective on an Old 

Problem. http://academy.asm.org/images/stories/documents/antibioticresistance.pdf (pp.1-5, 10.) 

4 American Academy of Microbiology, 2009. (p.8.)

5

http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM

052519.pdf See Table 6, p.22.

6 2011 TR lines 549-551: “There is a high probability that oxytetracycline resistant bacteria are present in the 

environment as a consequence of pesticidal use of oxytetracycline which may have negative health 

consequences for humans (EPA, 2006).” American Academy of Microbiology, 2009. p.2: “Controlling antibiotic 

resistant bacteria and subsequent infections more efficiently necessitates the prudent and responsible use of 

antibiotics. It is mandatory to prevent the needless use of antibiotics...”

7 T.F. O’Brien, 2002. Emergence, Spread, and Environmental Effect of Antimicrobial Resistance: How Use of 

an Antimicrobial Anywhere Can Increase Resistance to Any Antimicrobial Anywhere Else, Clin Infect Dis. 34 

Suppl 3:S78-84. “Use of an antimicrobial agent selects for overgrowth of a bacterial strain that has a gene 

expressing resistance to the agent. It also selects for the assembly and evolution of complex genetic vectors 

encoding, expressing, linking, and spreading that and other resistance genes. Once evolved, a competitive 

construct of such genetic elements may spread widely through the world’s bacterial populations. A bacterial 

isolate at any place may thus be resistant—not only because nearby use of antimicrobials had amplified such a 

genetic construct locally, but also because distant use had caused the construct or its components to evolve in 

the first place and spread there. The levels of resistance at any time and place may therefore reflect in part the 

total number of bacteria in the world exposed to antimicrobials up until then.”

K.M. Shea, 2003. Antibiotic Resistance: What is the Impact of Agricultural Uses of Antibiotics on Children’s 

Health? Pediatrics 112: 253-258. http://pediatrics.aappublications.org/content/112/Supplement_1/253.full.html

8 One time was in the 2008 testimony of former NOSB member Rebecca Goldburg, writing on behalf of Keep 

Antibiotics Working. She said, “A first concern is that the use of antibiotics on fruit trees likely makes at least a 

small contribution to the growing crisis of antibiotic resistance in human medicine. Modern molecular tools for 

tracking the movement of genes make clear that antibiotic resistance is an ecological and not just a medical 

problem. The use of antibiotics selects for resistant bacteria, whether in orchards or hospitals. Even if these 

resistant bacteria are not human pathogens, gene transfer mechanisms special to bacteria allow these 

microbes to spread their resistance genes to other, unrelated bacteria, including pathogens. Although the odds 

are very low that resistance genes from any particular orchard bacterium will end up in bacteria harmful to 

humans, such highly unlikely individual events become probable given the vast numbers of bacteria present in 

soil, water, and living organisms. In short, the use of antibiotics in orchards increases the load of antibiotic 

resistance genes in the environment, and thus likely contributes at least modestly to medical problems from

resistant bacteria.”

9 American Academy of Microbiology, 2009. “Horizontal gene transfer—the movement of genetic material from 

one organism to another—is the primary mechanism by which bacteria acquire antibiotic resistance.” 

10 WHO, 2009. See Table 1.

11http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UC

M052519.pdf See Table 6, p.22.

12 American Academy of Microbiology, 2009. p.10. “Selection takes place anywhere an antibiotic is present, 

especially in natural environments...”

13 T.F. O’Brien, 2002. “The basic event in selection is simple. Enough molecules of the antimicrobial agent 

impinge on a bacterial cell that is about to divide to stop it from doing so, while in its place another cell divides 

that would not otherwise have divided. The second cell divides either because it was not inhibited by the same 

exposure (i.e., had some level of resistance) or because it did not quite get that same exposure (e.g., by being 

a bit away and coming into the space later).” 

14American Academy of Microbiology, 2009 (p.8): “Horizontal gene transfer—the movement of genetic material 

from one organism to another—is the primary mechanism by which bacteria acquire antibiotic resistance. 

Antibiotics promote this genetic exchange by inducing the transfer of conjugative elements.” T.F. O’Brien, 

2002, p.1: “Use of an antimicrobial agent selects for overgrowth of a bacterial strain that has a gene expressing 

resistance to the agent. It also selects for the assembly and evolution of complex genetic vectors encoding, 
 

expressing, linking, and spreading that and other resistance genes. Rustam I. Aminov, 2011. Horizontal gene 

exchange in environmental microbiota, Front Microbiol. 2011; 2: 158: “There is a substantial body of evidence 

suggesting that the sub-inhibitory concentrations of antibiotics may significantly increase the frequency of 

horizontal transfer of many types of MGEs [mobile genetic elements].”

15 American Academy of Microbiology, 2009, p.8: “The transfer of antibiotic resistance genes is evident 

between bacteria or fungi of the same species, but transfer between organisms that bear limited phylogenetic 

relatedness, including transfer between gram-negative and gram-positive species, is also possible.” 

16 T.F. O’Brien, 2002 p.5:“The abundance of E. coli implicates them as the likely predominant vehicles for the 

spread of resistance genes and vectors, as opposed to the spread of infection, between the bacterial 

populations of animals and humans...” 

17 T.F. O’Brien, 2002. p.4: “A resistant strain made prevalent by selection in the bacterial populations of one 

host is more likely to be among the strains that the host transfers to a second host [15]. Similar selection in the 

second host would boost the strain’s chances of becoming established, amplified, and then transferred to a 

third host.”

18 American Academy of Microbiology, 2009. p.2: “Controlling antibiotic resistant bacteria and subsequent 

infections more efficiently necessitates the prudent and responsible use of antibiotics. It is mandatory to 

prevent the needless use of antibiotics...” T.F. O’Brien, 2002. p.6: “Management of such systems necessitates 

restraint and understanding. The global interdependence of antimicrobial resistance requires that we restrain 

antimicrobial use to its essential minimum—not just locally, but everywhere in the world.”

19 WHO, 2009. http://en.wikipedia.org/wiki/Tetracycline_antibiotics “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 drugresistance is occurring, and their effects on overall mortality is questioned.”

20 K. Kumar, S.C. Gupta, Y. Chander, and C.J. Rosen, 2005. Antibiotic Uptake by Plants from Soil Fertilized 

with Animal Manure. J. Environ. Qual. 34:2082–2085 (2005). W.D. Kong, Y.G. Zhu,

,, Y.C. Liang, J. Zhang, F.A. 

Smith, and M. Yang, 2007. Uptake of oxytetracycline and its phytotoxicity to alfalfa (Medicago sativa L.). 

Environmental Pollution, Volume 147, Issue 1, May 2007, Pages 187-193. RC Sinha and EA Peterson, 1972. 

Uptake and persistence of oxytetracycline in aster plants and vector leafhoppers in relation to inhibition of 

clover phyllody agent, Phytopathology 62: 50-56.

21 United States Environmental Protection Agency. 2005. Oxytetracycline. Section 3 Use on Apples. Summary 

of Analytical Chemistry and Residue Data. HED Records Center Series 361 Science Reviews, File R104981. 

Washington, DC. http://www.epa.gov/pesticides/chem_search/cleared_reviews/csr_PC-006304_3-Jan05_a.pdf “Oxytetracycline tolerances are currently established on peaches and pears at 0.35 ppm in terms of 

oxytetracycline, only. A tolerance on apple is proposed, also at 0.35 ppm. The crop field trials were conducted 

from 0.5 to 11.6X the proposed seasonal rate of 1.53 lb ai/A and from 49 to 61 days PHI as compared to the 

proposed PHI of 60 days. Residues were largely at the limit of quantitation (LOQ) of 0.013 to 0.2 ppm up to 

0.252 ppm for a 1X study in Region V [MI]. Adequate storage stability data were presented to indicate that the 

residues of oxytetracycline were stable for the duration of the residue field trial studies.”

22 2011 TR lines 291-294: “Once released into the soil, oxytetracycline is expected to become strongly 

adsorbed to soil particles and have moderate to no mobility (Kumar et al., 2005; HSDB, 2006). This means it 

can remain in soil for a long time following treatment. Furthermore, it is not likely to leach below the surface soil 

(Aga et al., 2005), however it can spread by surface run-off of sediment.” 2011 TR 322-325: “Chander et al. 

(2005) demonstrated that even though tetracycline was tightly adsorbed to clay particles in soil, it was still 

biologically active” following a 24-hour incubation period. There is a concern that the persistence of 

oxytetracycline residues in the environment may contribute to the development of bacterial resistance to 

oxytetracycline and other tetracyclines (Arikan et al., 2007).”

23 Tetracycline TR, January 27, 2006, , lines 279-293: “Workers (pesticide mixers, loaders, and applicators) 

are likely to be exposed to greater amounts of calcium oxytetracycline than the general public during its 

application to pears, peaches, and nectarines using foliar application methods; fieldworkers also can be 

exposed post-application (EPA 1988).” Although EPA at the time judged these exposures to be “negligible”, 

this is not an appropriate judgment under OFPA, and as we have seen above, no exposure to an antibiotic is 

negligible. 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. “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.” 

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: “Chickens were fed tetracycline-supplemented feed (tet-feed), and, as expected, within one week 

their intestinal flora contained almost entirely tetracycline-resistant organisms. Increased numbers of resistant 

intestinal bacteria also appeared, but more slowly, in farm members, but not their neighbors. Within five and six 

months, 31.3 per cent of weekly fecal samples from farm dwellers contained greater than 80 per cent 

tetracycline-resistant bacteria as compared to 6.8 per cent of the samples from the neighbors (P less than 

0.001).”

24 2011 TR lines 549-551: “There is a high probability that oxytetracycline resistant bacteria are present in the 

environment as a consequence of pesticidal use of oxytetracycline which may have negative health 

consequences for humans (EPA, 2006).”

25 See Mycoshield MSDS a: http://www.cdms.net/LDat/mp246000.pdf

26 2006 TR Lines 154-162.

27 Lines 458-467.

28 Lines 469-511.

29 Lines 521-522.

30 American Academy of Microbiology, 2009. 

31 American Academy of Microbiology, 2009, pp.5-6.

32 American Academy of Microbiology, 2009, p.12.

33 American Academy of Microbiology, 2009, p.12.

34 EPA, 2008. Oxytetracycline Summary Document Registration Review: Initial Docket, December 2008, p.8. 

“The Agency found that the pharmaceutical oxytetracycline exposure a user is expected to receive from a 

typical therapeutic dose is 50,000 to 200,000 times greater than the estimated dietary exposure from the 

pesticidal sources of oxytetracycline.”

35 American Academy of Microbiology, 2009., p.10: “Selection takes place anywhere an antibiotic is present, 

especially in natural environments...”

36 2011 TR line 463.

37 2011 TR line 464.

38 2011 TR lines 457-467.

39 W.D. Kong, Y.G. Zhu,

,, Y.C. Liang, J. Zhang, F.A. Smith, and M. Yang, 2007. Pages 187-193.

40 RC Sinha and EA Peterson, 1972.

41 2011 TR lines 452-453.

42 WHO, 2009. See Table 1.

43http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UC

M052519.pdf. See Table 6, p.21.

44 American Academy of Microbiology, 2009, p.7.

45 .” T.F. O’Brien, 2002, p.5.

46 Popowska M., Rzeczycka M., Miernik A., Krawczyk-Balska A., Walsh F. & Duffy B. (2012). – Influence of soil 

use on prevalence of tetracycline, streptomycin and erythromycin resistance and associated resistance genes. 

Antimicrob. Agents Chemother., 56 (3), 1434–1443. 

47 See NOSB, 2008. Principles of Organic Production and Handling, adopted by the NOSB October 17, 2001, 

and NOSB Guidance Document on Compatibility with a System of Sustainable Agriculture and

“Consistency with Organic Farming and Handling,” adopted by the NOSB October 24, 2003, revised April 29, 

2004.

48 NOSB Principles of Organic Production and Handling says, “An organic production system is designed to... 

Utilize production methods and breeds or varieties that are well adapted to the region...”

49 NOSB Principles of Organic Production and Handling says, “Organic agriculture is an ecological production 

management system that promotes and enhances biodiversity, biological cycles, and soil biological activity. It 

emphasizes the use of management practices in preference to the use of off-farm inputs, taking into account 

that regional conditions require locally adapted systems. These goals are met, where possible, through the use 
 

of cultural, biological, and mechanical methods, as opposed to using synthetic materials to fulfill specific 

functions within the system.”

50 NOSB Principles of Organic Production and Handling says, “Organic production and handling systems strive 

to achieve agro-ecosystems that are ecologically, socially, and economically sustainable.”

51 American Academy of Microbiology, 2009, p.3. “The struggle against antibiotic resistance is a war we will 

never win. The strength of trillions upon trillions of microorganisms, combined with the ancient force of 

evolution by constant, unrelenting variation, will inevitably overpower our drugs.”

52 Streptomycin TR, March 8, 2011. Lines 506-507.

53 See comments of former NOSB member Hubert Karreman on antibiotics 4/13/2011. 

http://www.regulations.gov/?source=govdelivery#!documentDetail;D=AMS-NOP-11-0014-2686 “As a 

veterinarian you cannot use antibiotics in organic livestock, I see the use of tetracycline and streptomycin as a 

sick joke. To allow them for use for non-sentient crops and not allow them to relieve pain and suffering in 

sentient animals is unethical at best and shockingly appalling at least.”

54 See 2011 Tetracycline Technical Report, lines 226-230.

55 http://www.organicitsworthit.org/quick/antibiotics-101 “Go organic! By law, organic products must be made 

without the use of antibiotics.” http://www.organicvalley.coop/why-organic/antibiotics/ “Organic Means No 

Antibiotics” http://www.earthsbest.com/products/product/2392320005 (Earth’s Best First Pears): “USDA 

organic: no growth hormones, antibiotics, steroids or potentially harmful pesticides or herbicides.” Even USDA 

expects it: http://www.usda.gov/wps/portal/usda/usdahome?navid=ORGANIC_CERTIFICATIO “U.S. producers 

are turning to certified organic farming systems as a potential way to lower input costs, decrease reliance on 

nonrenewable resources, capture high-value markets and premium prices, and boost farm income. Organic 

farming systems rely on ecologically based practices such as cultural and biological pest management, 

exclusion of all synthetic chemicals, antibiotics, and hormones in crop and livestock production.” (Accessed 

1/20/2013.)

NOSB Guidance on Compatibility with a System of Sustainable Agriculture and Consistent with Organic 

Farming and Handling, question number 5: Does the substance satisfy expectations of organic consumers 

regarding the authenticity and integrity of organic products?

56 Ostenson, H.T. 2010. Organic pome and cherry production and marketing issues: Past, present and future. 

Acta Hort. (ISHS) 873:137-144 

57 In 1995, tetracycline and streptomycin were added to §205.601, but it was to be reviewed again in two years 

and a taskforce was to be organized to “explore antibiotic use in crop production. (NOSB minutes, Oct-Nov 

1995 meeting, lines 594-604.) In 2006, there was much discussion, including presentation of a statement from 

CDC opposing the use of the antibiotics in crops, and the question, “Is it possible to put forth a 

recommendation that we would like to have it taken off of the list within two years?” The antibiotics failed to get 

a two-thirds majority, but were relisted. (Transcript April 20, 2006.) In 2008, board members noted the 

advantage of the 2012 expiration date as a final end to tetracycline as a reason for supporting the motion to 

expand the listing to all forms of tetracycline. (Transcript November 19, 2008.) And in 2011, board members 

expressed frustration, e.g., “feeling the need to see progress,” “[T]he fact is that the committee now has twice 

in the period of time I've been on the Board, expressed itself, the beliefs that the antibiotics ought to come off 

the list...” “I wouldn't be able to vote for more than a two-year extension at this point.” (Transcript April 29, 

2011, pp.25, 32, 37.)

58 §6517(c)(1): “The National List may provide for the use of substances in an organic farming or handling 

operation that are otherwise prohibited under this chapter only if -

(A) the Secretary determines, in consultation with the Secretary of Health and Human Services and the 

Administrator of the Environmental Protection Agency, that the use of such substances 

(i) would not be harmful to human health or the environment;

(ii) is necessary to the production or handling of the agricultural product because of the unavailability of wholly 

natural substitute products; and

(iii) is consistent with organic farming and handling;

59 NOSB transcript, April 26, 2011, p.380.

60 Washington State Department of Agriculture printout, “International Organic Program—EU Compliant 

Operations, March 10, 2011. http://agr.wa.gov/FP/Pubs/docs/wsda_eu_compliant.pdf
 61 Johnson, Ken, Oregon State University, Fire Blight control in Organic Pome Fruit Systems Under the 

Proposed Non-antibiotic Standard, E-Organic Webinar, March 13, 2012. R.D. Koski and W.R. Jacobi Fire

Blight. Colorado State University Extension. October 2009. 

62 Norelli, John L., Alan L. Jones, and Herb S. Aldwinckle. "Fire blight management in the twenty-first century: 

using new technologies that enhance host resistance in apple." Plant Disease 87.7 (2003): 756-765. “In the 

twentieth century, fundamental changes in the apple industry resulted in the adoption of high-density orchard 

systems, and recent planting of susceptible cultivars and rootstocks has increased the danger of fire blight in 

apple orchards to unprecedented levels.”

63 Paul W. Steiner, 2000. A Philosophy For Effective Fire Blight Management, Presented at the State 

Horticultural Association of Pennsylvania Annual Meeting, January 2000. 

http://www.caf.wvu.edu/kearneysville/articles/PHILOSOPHY2000.html