NOP: Proposed Amendments to the National List of Allowed/Prohibited Substances - Oxytetracycline - Organic Trade Association
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NOP: Proposed Amendments to the National List of Allowed/Prohibited Substances - Oxytetracycline


January 9, 2012

Toni Strother, Agricultural Marketing Specialist
National Organic Program, USDA–AMS–NOP
1400 Independence Ave., SW

Room 2646–So., Ag Stop 0268

Washington, DC 20250–0268

RE: National Organic Program, Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops, Livestock and Processing)

Comment on Docket number AMS-NOP-11-0058-0001

Dear Ms. Strother:

Thank you for the opportunity to comment on the proposed rule to extend oxytetracycline on the National List until Oct 21, 2014. This proposed rule would amend § 205.601 by changing the annotation at paragraph (i)(12) to add an expiration date and specify the permitted use for oxytetracycline.

The Organic Trade Association (OTA) is the membership-based business association for organic agriculture and products in North America. Its members include growers, shippers, processors, certifiers, farmers’ associations, distributors, importers, exporters, consultants, retailers and others. OTA’s Board of Directors is democratically elected by its members, and its mission is to promote and protect the growth of organic trade to benefit the environment, farmers, the public and the economy (http://www.ota.com/). OTA represents hundreds of certified operations that will be impacted by the final rule.

OTA supports the complete phase-out of antibiotics in organic tree fruit production. However, we’re concerned that the proposed deadline of 2014 is not based on scientific evidence, and will not allow for the time needed to identify and develop commercially viable alternatives.

OTA is committed to supporting research and efforts to finding alternative materials and methods for controlling fire blight without the use of antibiotics. The National Organic Standards Board (NOSB) proposed a time-limited extension for tetracycline to allow for the continued use of the material while encouraging the industry to increase its efforts to research and develop commercially viable alternatives. It also included a deadline of 2014 in the material’s annotation to convey the urgency of consumer and public interest groups’ advocacy of eliminating the use of tetracycline in organic tree fruit production. However, based on the information we have received from both our member growers as well as researchers, we believe that the time needed to address the use of oxytetracycline in organic tree fruit production is much longer than 2014. It is useful to note in the USDA-NASS Agricultural Chemical Usage database, which includes oxytetracylcine, that the percent of apple acres treated in a given year nationally ranges from 1-9%; thus a small portion of the apple crop is treated with this allowed material in any given year.

The proposed expiration date of 2014 is as arbitrary as the current expiration date of 2012 because it is not based on well-documented scientific evidence as to the availability of proven alternatives. Based on the research collected and presented by the Organic Tree Fruit Group1 at the Fall 2011 NOSB meeting, there are organic-compliant biocontrol materials registered for fire blight, but published scientific data have shown that these are not stand-alone replacements for antibiotics. Additionally, changing rootstock to alternative resistant varieties of apples and pears does not address infections that occur on the top of a tree. Furthermore, “Geneva”2 rootstock will not be available in commercial quantities before 2014 or 2015. Good progress is being made on alterative controls for fire blight in organic systems. However, according to a recently funded USDA-OREI project in Oregon, Washington, and California, effective biological fire blight control without antibiotics will not be available until 2016. A switch to “resistant” varieties will take a much longer time, likely a decade, and such varieties must be proven acceptable to consumers or they will not be viable choices.

As presented in the petition to remove the expiration date of 2012 and in the Organic Tree Fruit presentation, the premature loss of oxytetracycline for control of fire blight in organic apples and pears will result in a significant net reduction in the amount of organic apples and pears produced in major pome fruit-producing states such as California, Michigan, and New York, but particularly in the Pacific Northwest. Despite this information, the proposed rule was not classified as “significant.” We are concerned that the National Organic Production (NOP) may have underestimated the impact the loss of the material will have. Thus, we ask that special attention and careful consideration be given to the comments received describing the financial impact the proposed rule will have on farmers and businesses.

Based on a preliminary economic assessment3 conducted by David Granatstein for the state of Washington, the loss of oxytetracycline would cause economic impact both through increased costs to growers (manually cutting infected limbs and trees) and loss of organic price premiums for those acres likely to be removed from organic status. This could result in an annual cost for Washington growers ranging from $8.77-16.54 million per year. This would account for an estimated 80-85% of the national economic impact to organic growers. Organic handlers and distributors would also be significantly affected due to the amount of organic apples and pears used in processed products, particularly as organic apple juice used in other juices and as an organic sweetener used in several other types of products. According to OTA’s 2011 Organic Industry Survey, beverages accounted for 13.2% of U.S. organic food sales in 2010 and of that, fresh, canned and bottled juice accounted for 26.7% totaling 884 million dollars in consumer sales. Based on juice production reports from our members, we estimate that at least 7-10% of those sales can be attributed to organic pear and organic apple juice.

Given the lack of commercially available effective alternatives to oxytetracycline and the essential role it currently plays in the successful production of organic pears and apples (used infrequenty, but essential when disease models indicate high risk of infection), OTA is extremely concerned that the 2014 expiration date is premature and the loss of use of oxytetracycline will have significant impact on the organic sector. OTA supports the development and adoption of a phase-out plan that includes clear science-based benchmarks for progress with non-antibiotic fire blight control that can be periodically monitored and communicated to NOSB.


On behalf of our members across the supply chain and the country, OTA thanks NOP for the opportunity to comment on this Proposed Rule.

Respectfully submitted,

Gwendolyn Wyard

Associate Director of Organic Standards and Industry Outreach

Organic Trade Association

cc: Laura Batcha
Executive Vice President
Organic Trade Association


1An Organic Tree Fruit Group was formed at the request of the NOSB to help keep it informed of progress with non-antibiotic control techniques.

2 The expiration date of 2014 recommended by NOSB was partly predicated on the availability
of “resistant” varieties of apples and pears, including the new ‘Geneva’ apple rootstock series.


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