OTA Consolidated Comments to NOSB, April 2010
April 12, 2010
Certification, Accreditation and Compliance – Use of Inert Atmospheric Gases in Products Labeled as 100% Organic
The Organic Trade Association (OTA) thanks the National Organic Standards Board (NOSB) for the opportunity to provide comments.
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. OTA's mission is to promote and protect the growth of organic trade to benefit the environment, farmers, the public and the economy (www.ota.com).
OTA supports this recommendation as written.
Crops -- Guidance Recommendation on Inerts in Pesticides Allowed for use in Organic Production
OTA appreciates the difficulty of addressing the issue of inert ingredients in pesticide formulations in light of the U.S. Environmental Protection Agency’s (EPA’s) revision of its classification system. We recognize that the National List will need to be revised in light of EPA’s discontinuation of its classification system for substances used as inert ingredients in pesticide formulations, and understand that amendments to the NOP rule will have to be worked out in collaboration between NOSB and the National Organic Program (NOP).
However, we do not support the recommendation put forward by the Crops Committee on how to proceed, particularly the suggestion that “the NOSB needs to review all inert ingredient components used in current NOP compliant pesticide formulations for consideration for inclusion on the National List of Allowed Materials on 205.601.” The recommendation as proposed would result in a significant loss of tools available to organic growers, along with confusion and concern within the industry and among consumers.
We do not believe that the intent of the Organic Foods Production Act (OFPA) was to turn NOSB into a smaller version of EPA in order to review individual inert ingredients in pesticide formulations. The current recommendation would do just that, albeit only for those substances that pesticide manufacturers agree to submit for petition. It would also result in a huge and unnecessary burden on the already over-worked NOSB. We understand that there are estimated to be over 250 unique substances used as inerts in pesticide products currently approved for use in organic production. Even if many of these are determined to be non-synthetic or are already on the National List, the petitioned list could be quite lengthy.
Since EPA is in the process of requiring that all inert ingredients in pesticide products be
revealed on product labels, we do not believe that it makes sense to require all manufacturers of pesticide products approved for use in organic production to submit complete lists of ingredients in these products to NOP, and then to petition for NOSB to approve those ingredients that are synthetic and not already approved elsewhere on the National List. This would unfairly require a petition process for continued allowance of substances that are currently permitted under the old EPA classification system. Our members have expressed the concern that many pesticide manufacturers would not be likely to pursue this option as their “approved for organic production” lines do not constitute a significant share of their business. This would result in loss of valuable tools for organic farmers, particularly in the area of biological controls, and would likely cause disruption for the industry all along the supply chain.
Until such time as EPA requires disclosure of inert ingredients, we also believe that many pesticide manufacturers will not wish to reveal the ingredients in their formulas to NOP. We suggest that those inert substances that appear on the 2004 EPA List 4, minus those that have been deleted, should be “grandfathered” and remain accepted for use in organic production, subject to a Sunset provision. We do not believe that it was the intent of OFPA to require a full review of inert ingredients for compatibility with a system of organic farming.
OTA suggests that NOSB work with NOP, as well as with existing technical advisors such as OMRI, to consider different scenarios for adjusting to the changed regulatory environment resulting from EPA’s reclassification effort, rather than attempting to stand in for EPA. This would include closer collaboration with EPA as it proceeds, perhaps with some technical assistance in evaluating substances according to OFPA criteria.
NOSB should also consider whether or not specific substances allowed as inert ingredients in pesticide formulations really need to be included on the National List. One possibility might be to maintain these specific lists as part of the NOP Program Manual, which would not require developers of new products to undertake a National List petition process in addition to the required EPA clearance for its formulations.
Crops -- Production standards for terrestrial plants in containers and enclosures
As we commented previously, OTA appreciates the detailed guidance concerning organic greenhouse and container-grown plant production. We note that, while recommending to exclude hydroponic and aeroponic systems from organic production, the Crops ommittee remains silent on the question of aquaponics, requiring only that “growing media shall contain sufficient organic matter capable of supporting natural and diverse soil ecology.”
OTA supports keeping the NOP consistent with Canadian regulations, which currently prohibit organic labeling of agricultural products produced by hydroponic or aeroponic production methods. However, we note that the definition of “hydroponic” in Canada’s regulation is far more specific than that proposed in this recommendation. CAN/CGSB 32.310-2006, Amended October 2006, gives the following definition of ‘Hydroponics’:
Cultivation of plants (flowers and vegetables) in aqueous nutrient solutions without the aid of soil. The soil is replaced by an inert culture medium (e.g. coarse sands, expanded clay, rockwool). Plants are cultivated by using a nutritive solution that is brought to each plant by taking into account the requirements of the species.
We therefore suggest that NOSB include the above definition, which we believe is sufficiently specific to true hydroponic systems. This would not exclude the possibility of ecologically balanced aquaponic systems that integrate fish culture with plant production using only NOP-compliant substances and methods.
Crops -- Sunset Materials
OTA supports the recommendations for all items identified for continued use.
OTA appreciates the work NOSB has done to prepare for the upcoming review of 2012 sunset items. OTA is aware of the complexity of the task and understands how much work NOSB has done in preparation for this meeting.
However, OTA notes that the items in the documents NOSB has prepared are not completely consistent with the items published in the March 17 Federal Register Notice of meeting, and further that the Advance Notice of Proposed Rulemaking posted in the March 26 Federal Register for public comment by May 25 is also different, listing all 2010 sunset items. These multiple opportunities for comment, with multiple deadlines and multiple purposes, have caused confusion and unnecessary anxiety in the trade, especially given the new NOP policy requiring the defense of materials already reviewed, commented on, and listed. We hope NOP and NOSB can collaborate in the future to avoid such confusion. To maximize NOSB awareness of public opinion, the comment period for Federal Register advance notices of proposed rulemaking (ANPRs) for items to be considered by NOSB should close two weeks prior to the NOSB meeting at which those materials are discussed.
Handling -- Sunset 2012 Materials
OTA supports the recommendations for all items identified for continued use.
OTA appreciates the work NOSB has done to prepare for the upcoming review of 2012 sunset items. OTA is aware of the complexity of the task and understands how much work NOSB has done in preparation for this meeting.
However, OTA notes that the items in the documents NOSB has prepared are not completely consistent with the items published in the March 17 Federal Register Notice of meeting, and further that the Advance Notice of Proposed Rulemaking posted in the March 26 Federal Register for public comment by May 25 is also different, listing all 2010 sunset items. These multiple opportunities for comment, with multiple deadlines and multiple purposes, have caused confusion and unnecessary anxiety in the trade, especially given the new NOP policy requiring the defense of materials already reviewed, commented on, and listed. We hope NOP and NOSB can collaborate in the future to avoid such confusion. To maximize NOSB awareness of public opinion, the comment period for Federal Register advance notices of proposed rulemaking (ANPRs) for items to be considered by NOSB should close two weeks prior to the NOSB meeting at which those materials are discussed.
Joint Materials and Handling Committee – Classification of Materials
Clarifications of the Definitions of the National List
OTA thanks the Joint Materials and Handling Committee for helpful clarifications as well as an excellent start on a critically needed guidance document. We hope that the Materials Working Group can again be called upon to assist in further developing the guidance document as additional aspects of the classification of materials recommendation are put into place. At this time, we have the following comments on these documents.
Addendum to the November Recommendation
The proposed additional clarification of the previously recommended definition of “chemical change” is very helpful, but still leaves some room for unintended consequences. OTA supports an additional revision stating that this clarification only applies to products to be used in producing a product for human or animal consumption, and does not apply to substances to be used as crop or livestock production inputs.
We also appreciate the clarification of the definition of “nonagricultural,” and agree that an agricultural product should remain agricultural no matter how it is processed or what it is combined with. However, we believe that that the revised definition misses the mark of consistency with the range of products that can be, and are currently being, certified organic under NOP. By tying the definition of agricultural to “crops or livestock,” the current definition of “crop” as “a plant or part of a plant…” falls short. We would point to several examples of organisms, including mushrooms and kelp, that are cultivated or wild harvested as crops and certified organic under NOP but technically are not plants.
OTA supports the reclassification of yeast as “agricultural,” which this document indicates will now be considered. We continue to suggest that any living organism that can be cultivated or cultured by humans (i.e., products from naturally occurring biological processes) could potentially be certifiable as organic and thus included in the category of “agricultural” products.
We also urge NOSB and NOP to continue exploring the possibility of revising the regulations to make all sections of the National List applicable to handling substances to require sourcing of organic equivalents where they are commercially available. This alone would alleviate some of the need to determine whether a specific substance used in handling is agricultural or nonagricultural.
Finally, we support the time frame as outlined in the Addendum for incorporating the proposed changes into regulations and implementation by certifiers.
Draft Guidance Document on Classification of Materials
OTA commends the Joint Committee on Materials and Handling for an excellent first step in bringing much needed consistency to materials decisions that must be made by certifiers and NOSB. Our primary concern with this guidance relates to the problem of applying the same review criteria to substances intended to be used as crop or livestock production inputs as are applied to substances intended for use in handling products labeled as “organic” or “made with organic.” For example, the question whether a substance is agricultural or nonagricultural is not relevant to crop or livestock inputs except for livestock feed ingredients. We support the need to develop separate review work sheets for crop, livestock and handling inputs, with different questions posed as applicable.
OTA welcomes the intent of the Joint Committee to more clearly define “significant levels” of synthetic substances that may remain in an otherwise non-synthetic substance.
Another dilemma that continues to arise in the classification of materials is the policy that requires only 100% organic agricultural products in anything fed to livestock, whether as a feed supplement or minor ingredient in a formulated livestock feed. OTA supports the possibility of allowing non-organic agricultural products to be included as feed supplements or minor ingredients in livestock feeds, subject to commercial unavailability of organic equivalents. This would alleviate some of the problems related to reclassification of certain ingredients, such as yeast, kelp and fishmeal, which currently are or may soon become commercially available in organic form, yet non-organic forms may be fed to livestock because these products are not recognized as “agricultural.”
We note that several of our members who work directly with these questions have identified examples of materials that remain problematic using this draft guidance. Beyond this, we suggest that the Materials Working Group again be called upon to provide additional assistance in developing guidance materials for the classification of materials. OTA would be pleased to continue helping to facilitate the work of the Materials Working Group.
Livestock -- Livestock health care substances
OTA supports both of the Livestock Committee’s recommendations for clarification related to the Animal Welfare recommendation approved in November. We particularly welcome the clarification that organic young stock can continue to nurse from mothers during withholding times for permitted veterinary treatments without compromising the offspring’s organic status.
We also support the intent of the Livestock Committee’s clarification concerning the use of preventative animal health care substances. However, we believe that the proposed new definition does not solve the problem of preventative homeopathic and herbal treatments being lumped with synthetic veterinary drugs, which are prohibited “in the absence of illness.”
There is currently no reference to ‘animal health care substances’ in the National Organic
Program (NOP), and so the addition of this new definition would not be appropriate without adding a provision in the regulation that uses this term.
This new definition also does not change the reference to the Federal Food, Drug, and
Cosmetic Act (FFDCA) in the NOP definition of “animal drug,” which means that any homeopathic product, as well as any product “used in the diagnosis, cure, mitigation, treatment, or prevention of disease,” could not be used in the absence of illness. We do not believe that either the Organic Foods Production Act or NOP intended to prohibit the use of non-synthetic substances to prevent illness, and therefore support revising Section
205.238(c)(2) to refer to use of synthetic medications permitted under Section 205.603 in the absence of illness, rather than the entire category of animal drugs.
OTA also suggests that NOSB only needs to provide information supporting the rationale for including this technical correction in a proposed rule change to NOP rather than concerning itself with correctly crafting this regulatory verbiage.
Livestock -- Methionine, 2010 Deadline
OTA supports the recommendation, with the following adjustments:
OTA suggests that the reduction of the allowed amount by two pounds per ton applied to layers also be applied to pullets (which are not currently treated separately, although, as growing chickens, they have higher nutrient needs) and broilers. Broilers, which under the current proposal could receive an extra pound per ton, together with pullets, should be able to receive three pounds per ton of synthetic methionine per ton instead of two.
NOSB’s current language for the allowances for birds after October 1, 2012, is:
…After October 1, 2012, the following maximum levels per ton: Laying and
Broiler chickens – 2 pounds per ton; and Turkeys and all other poultry - 3 pounds
per ton.
OTA proposes:
…After October 1, 2012, the following maximum levels per ton: Laying chickens – 2 pounds per ton; Pullets, Broiler chickens, Turkeys and all other poultry – 3 pounds per ton.
There are both immunity and developmental reasons for allowing a higher usage of
methionine for pullets (females under one year of age, or future layers) and broilers: for pullets as a stage of life requiring more nutrition and as growing birds more susceptible to disease than mature birds, and for broilers because they grow faster than laying hens.
OTA appreciates the consideration NOSB has given to consumer expectations, the principles of organic agriculture, and the needs of the trade by allowing additional time for the development of natural alternatives to synthetic methionine.
OTA also very much appreciates NOSB’s recognition that at least some synthetic methionine is currently necessary for the production of poultry, and its proposal to phase in its new recommendation. OTA especially appreciates the Livestock Committee’s intent to stimulate further development and management changes in the organic poultry industry that will meet consumer expectations and organic principles.
Finally, OTA notes that any growth in the available supply of natural methionine can and should be addressed during the sunset process.
Livestock -- Animal Welfare (Stocking Rates)
OTA requests that NOSB use the data being gathered by NOP as part of the U.S.-Canadian equivalency agreement, and not take action on this issue before considering that data.
The equivalency agreement states the following (Canadian Food Inspection Agency letter to USDA, June 17, 2009, Appendix 1, #3,
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5077628&acct=nopgeninfo):
Agricultural products derived from animals must be produced according to livestock stocking rates as set out in CAN /CGSB32.310-2006 (amended October 2008).
This data will allow standards setters to see clearly any gaps between U.S. practice and the Canadian standards. Data are being collected for all operations, not just exporters, and for all species being certified. A decision based on the review of this relevant and current data seems wise.
This data would also give NOSB some idea whether producers might already meet proposed numbers, or how long it might take producers to meet an NOSB recommendation, whether for rulemaking or guidance. Building additional housing or reducing operation size would take considerable planning and preparation.
OTA understands that the National Organic Program is slated to deliver these numbers to Canada by the end of this year, which means that preliminary numbers should be available well before NOSB’s next meeting.
Slaughter
In response to a video released by the Humane Society of the United States, the U.S. Department of Agriculture (USDA) and the Vermont Department of Agriculture moved to shut down the Grand Isle, VT, slaughter facility implicated in allegations and evidence of gross animal cruelty on November 2, 2009. These reports are shocking, especially in light of the organic processing certificate held by the facility.
OTA urges that now is the time to clarify that animal living standards apply until the time of slaughter, with slaughterhouses required to meet all handling requirements and livestock living conditions set forth in the rule in order for a meat product to be labeled and sold as organic. OTA believes the current regulation, preamble and Q&A on the NOP web site lack the necessary alignment and clarity to assure consumers that meats sold as organic are not only raised but slaughtered in a manner consistent with the expectation that animal welfare is a basic principle of organic production.
Slaughtering is referenced in § 205.270 Organic handling requirements.
(a) Mechanical or biological methods, including but not limited to cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, distilling, extracting, slaughtering, cutting, fermenting, eviscerating, preserving, dehydrating, freezing, chilling, or otherwise manufacturing, and the packaging, canning, jarring, or otherwise enclosing food in a container may be used to process an organically produced agricultural product for the purpose of retarding spoilage or otherwise preparing the agricultural product for market.
The preamble suggests a handler (slaughterhouse) should comply with applicable provisions of subpart C (this would include livestock standards).
This subpart sets forth the requirements with which production and handling operations must comply in order to sell, label, or represent agricultural products as "100 percent organic," "organic," or "made with organic (specified ingredients or food group(s))." The producer or handler of an organic production or handling operation must comply with all applicable provisions of subpart C.
NOP’s AQSS web page includes the following relevant question and answer:
Is there any difference in how organic animals are treated and processed during the slaughter at the processing plant versus conventional animals? Are there different conditions for organically raised animals, or are the conditions the same as for animals not raised organically? Is there any difference between a meat processing plant that handles organic meat and one that doesn’t? Is there a way to find out where an organic company has its animals processed? Is there information on the web somewhere that lists meat processing plants that handle organic meat?
Yes, there are differences. The NOP requirements for livestock, edible livestock products, and handling (processing) can be found at the NOP website at http://www.ams.usda.gov/nop. Click on the standards, and then click on Livestock. For a list of livestock operations, we will soon be publishing a list of certified operations on the NOP website.
Please note that the “Livestock” section refers to the livestock production standards, not the handling standards.
It appears most slaughter operations are held to the handling standard to prevent comingling and to guarantee for example that the organic hog that is dropped off is the same animal as the organic ham picked up.
NOSB and NOP are currently engaged in comprehensive work on the livestock and animal welfare standards. It would be unfortunate not to address this issue at this time as well.
Livestock -- Sunset Materials
OTA supports the recommendations for all items identified for continued use.
OTA appreciates the work NOSB has done to prepare for the upcoming review of 2012 sunset items. OTA is aware of the complexity of the task and understands how much work NOSB has done in preparation for this meeting.
However, OTA notes that the items in the documents NOSB has prepared are not completely consistent with the items published in the March 17 Federal Register Notice of meeting, and further that the Advance Notice of Proposed Rulemaking posted in the March 26 Federal Register for public comment by May 25 is also different, listing all 2010 sunset items. These multiple opportunities for comment, with multiple deadlines and multiple purposes, have caused confusion and unnecessary anxiety in the trade, especially given the new NOP policy requiring the defense of materials already reviewed, commented on, and listed. We hope NOP and NOSB can collaborate in the future to avoid such confusion. To maximize NOSB awareness of public opinion, the comment period for Federal Register advance notices of proposed rulemaking (ANPRs) for items to be considered by NOSB should close two weeks prior to the NOSB meeting at which those materials are discussed.
Materials – Nanotechnology
OTA supports this call for additional scientific and technical information and thanks
NOSB for its attention to the need to clarify the issues surrounding the term “nanotechnology.” OTA stands ready to work with our members to help identify problems and solutions.
OTA further commends the Materials Committee for stating that it “does not intend to include in the category of nanotechnology those naturally-occurring substances or substances caused as a result of traditional food processing techniques. Products such as, but not limited to, wheat flour dust, homogenized milk, or even colloidal minerals as they have been marketed for decades, are not intended to be included in this definition.”
Nanotechnology’s profile was recently raised through the filings of HR 554 in February of 2009, which provides support for nanotechnology research and development, and S 2942, filed just three months ago, which calls for the U.S. Food and Drug Administration to establish a nanotechnology program, partly to study its possible negative effects.
OTA further recognizes and supports the argument that constructed molecules are synthetic and are therefore already prohibited for use in the organic system unless specifically allowed.
However, some questions concerning how best to distinguish traditional and even beneficial uses and effects of very small particles from uses and effects that may not be beneficial or suitable for use in the organic system.
OTA remains concerned that the current paper does not sufficiently exempt any products or technologies that might be food or food manufacturing products or technologies, and does not sufficiently set criteria. Among the most cited processes in this regard are grinding and emulsification (including milk homogenization), as the intention in using these processes is to create small or even very small particles that could end up prohibited if proposed changes to the regulation are not written very carefully.
Just to be clear, emulsification is an intentional, not an inadvertent, process, often used to produce the smallest particles possible in order to create a different property than larger particles—the creaminess of a food. The unique property is a quality of the final product
as a whole, but it may also be a unique property of its small parts. The smaller the particle, the creamier the “mouth feel.” Similarly, whipping egg whites is most effective when the air particles around which the proteins cluster—at the molecular level—are as small as possible. OTA is therefore not entirely sure that NOSB’s stated purpose to prohibit “intentionally engineered substances produced for their unique and specific properties that result only when these substances are in the nanoscale size range” is sufficient to exclude these common techniques.
Finally, simply having unique properties should not be a criterion for prohibiting
materials. It is entirely possible that increased absorption of a material is beneficial if it
increases the bioavailability of a nutrient. The question should be whether any unique
properties include toxicity, not whether there are any unique properties.
Policy Development -- Section V—NOP/NOSB Collaboration
OTA appreciates the improved funding and staff resources now allocated to the National
Organic Program (NOP). We believe that this will greatly improve the ability of both
NOP and NOSB to serve the needs of our industry. With the volume of materials coming
up for sunset review, OTA recommends NOSB prioritize its role as statutory authority in
recommending materials to avoid trade disruption, backlog and market instability.
With the new level of NOP resources being dedicated to standards development, we
suggest that NOSB focus its role on justifying standards modifications and prioritizing standards development. NOSB recommendations that clearly outline intent, as in suggested preamble language, would be most beneficial and appropriate for NOSB’s collaborative role in this regard.
We agree it is appropriate for NOSB to take its direction from NOP in seeking public input for specific questions or gathering information needed to develop additional standards.
Policy Development -- Section VIII—Sunset review approaches
OTA supports Option 2B, the “evergreen” approach. We disagree with NOSB’s perspective that this means that materials are not fully reviewed periodically as required by the Organic Foods Production Act (OFPA) and the NOP Rule. OTA expects NOSB to review materials as fully as the Board decides is necessary. Nonetheless, the results of the initial review and subsequent NOSB votes should indicate that, in the absence of new information generated by the five-year reviews and public comments, the original reviews and decisions were reasonable. If a material does not deserve to be on the list, this information can be presented and the Board can vote. It remains up to the Board to determine the depth of the review, and this, too, can be informed by Board discussion and public comment. It is the quality of the reviews, not the number of items, which should determine the Board’s decision.
