NOSB Report-April 2011

Introduction
The following is a summary of the discussions had and the decisions made at the April 2011 National Organic Standards Board (NOSB) meeting in Seattle, WA. A complete transcript of this meeting will eventually be posted on the National Organic Program (NOP) website.

Video Presentation from Deputy Secretary Kathleen Merrigan
Following a brief introduction from NOSB chair Tracy Miedema, the April 2011 meeting began with a video featuring Deputy Secretary of Agriculture Kathleen Merrigan, who offered her thoughts on a number of items on the meeting agenda. In her opening remarks, Merrigan encouraged the Board to take “the greatest care” in developing recommendations and to keep an open mind. She also explained the decision to reduce the time for individual comments from 5 minutes to 3. As she noted, “we felt it was more important to hear from everyone than to limit public input.”

Merrigan then highlighted the progress at NOP that has been made under the Obama administration, including greater surveillance, more regulations, and increased investigation of complaints. She added, though, that more work is needed to address emerging issues such as the oversight of accredited certifying agents and the review of NOSB recommendations.

Next, Merrigan turned her attention to the issue of nutrient vitamins and minerals. She reminded NOSB that USDA cannot add materials to the National List, and that NOSB has the responsibility to conduct Sunset reviews. Additionally, she pointed out that NOP will prepare the final rule on Sunset 2012 items before June 2012, and implored NOSB to vote on nutrient vitamins and minerals at the April 2011 meeting.

Review of National List Process of Evaluating Materials
As at the Fall 2010 NOSB meeting, Materials Committee Chair Katrina Heinze provided a review of the National List (NL) process for evaluating materials and the NL criteria. Additionally, Heinze reminded NOSB of: a) its decision at the October 2010 meeting to allow annotation changes during the Sunset review process; b) the fact that reviews are based on the force of evidence; c) the Board’s practice of having the committee chair assign specific committee members to lead petitioned and Sunset materials reviews; and d) the Board’s practice to make motions on materials in the affirmative.

View Heinze’s full powerpoint presentation.

NOP Update
Following Katrina Heinze’s presentation on the National List process, NOP Deputy Administrator Miles McEvoy provided an update on NOP’s recent activities. He reviewed the NOP budget for fiscal year 2010 and 2011 ($6.9 million, respectively), as well as the requested budget for fiscal year 2012 ($9.8 million). He also highlighted recent changes in NOP personnel.

Next, McEvoy discussed NOP’s progress toward addressing issues raised in the March 2010 Office of Inspector General’s report, which outlined 14 recommendations for improvements. NOP has taken corrective action on 13 of these recommendations, and work on the remaining recommendation (number 9, calling for a peer review panel) is underway.

McEvoy then turned his attention to NOP’s 2010-2012 strategic plan, entitled “Organic Integrity from Farm to Table, Consumers Trust the Organic Label.” The plan has five distinct components: quality management, standards consistency, accreditation oversight, compliance and enforcement, and a management strategy. McEvoy reviewed NOP’s performance on each of these components, during which he highlighted such accomplishments as the publication of a Quality Manual, the first and second editions of the Program handbook, and a number of published rules, guidance, and notices; the completion of all foreign audits; the development of a new audit review checklist; the closing of 71 complaints in the first 6 months of FY 2011; the implementation of an enforcement action procedure of publishing notices of NOP fraudulent certificates; and the development of the Organic Insider newsletter to disseminate information.

The next section of McEvoy’s presentation focused on materials. In this section, McEvoy outlined the number of natural and synthetic substances allowed in crops, handling and livestock. He also reviewed the provisions of the Organic Foods Production Act (OFPA) related to materials, including those provisions outlining NOSB’s and NOP’s responsibilities related to materials reviews, and reminded NOSB that OFPA has no restrictions regarding the length of the National List. Additionally, McEvoy encouraged NOSB members to respect each other’s perspectives and the perspectives offered via public comment, adding that “We are all part of the same organic community, we will not always agree, and we should respect the process and the decisions made by the NOSB.”

Following these remarks, McEvoy delved into the issue of nutrient vitamins and minerals and the history behind it. He also outlined NOP’s action plan related to these materials, which includes a plan to publish draft guidance that will clarify the FDA interpretation of 21 CFR 104.20, under which only nutrient vitamins and minerals listed in 104.20(d)(3) and those identified as essential nutrients in 21 CFR 101.9 are allowed. McEvoy indicated that NOP will provide transition time for businesses to comply with this interpretation, and that draft guidance will be published in the Federal Register, followed by a 60-day comment period. Additionally, McEvoy, on behalf of NOP, advised companies that they may petition to add substances to the National List including nutrients, vitamins and minerals not allowed under 21 CFR 104.20.

View the full NOP update.

Inerts Working Group Update
Emily Brown Rosen provided an update to NOSB on the progress made by the Inerts Working Group. To begin, she reviewed the history of inerts in NOP. As part of this history, she reminded NOSB that EPA revised its system of assessment in 2006, and no longer uses List 1-4. As such, NOP’s references to Lists 3 and 4 are obsolete. To remedy this problem, NOSB passed a recommendation in April 2010 to create a memo of understanding (MOU) with EPA to assist in evaluation of former List 3s-4s and possibly create a task force to aid in this process. The recommendation also suggested asking manufacturers to provide information on all remaining synthetic inerts in current use to be reviewed individually as petitions.

Since that time, NOP has drafted an MOU with EPA and had meetings with EPA staff. An initial Work Group has also formed and begun data collecting and assessment.

The Work Group’s efforts have revealed that EPA currently lists all inerts used on food crops either as exempt from tolerance, or with specific tolerances for residues, on 40 CFR 180.910-180.960. Additionally, EPA classifies some inerts as permitted for use in Minimal Risk products– FIFRA 25(b).

Given this information, several options for next steps exist. The Inerts Working Group can review each individual inert, identify subgroups of EPA Part 180 that may be compatible with organic, or evaluate inerts currently used in organic for any patterns or grouping.

Some data collection towards these next steps has already begun. For example, OMRI and WSDA have shared lists of inerts in current use and compared this to EPA’s 25(b) list and the old List 4 to see where overlap and gaps exist. The Inerts Working Group will review this data and analyze it further, comparing it to the EPA 25(b) list and other EPA tolerance exempt categories and determining whether any of these categories can be referenced by NOP. Additionally, the Group plans to develop criteria for screening any materials that do not fall in the aforementioned categories.

View the Inert Working Group’s full presentation.

Welcome from WA State Department of Agriculture
Washington State Department of Agriculture Director Dan Newhouse addressed NOSB and welcomed members to Seattle, noting his appreciation for the decision to host NOSB meetings in different regions throughout the United States. He also acknowledged that the meeting room had standing room only, demonstrating, in his view, the strong level of interest in organic that exists at this time.

Mr. Newhouse then turned his attention to agriculture in Washington State. He noted that although agriculture is not something that people tend to associate with WA, the state is the third largest exporter of agricultural products in the United States. Moreover, he said, WA raises approximately 300 different crops on 39,000 farms across the state.

Mr. Newhouse went on to explain that organic agriculture has become an increasingly important part of WA’s agricultural landscape, generating $200 million from organic production. At the same time, he added, organic plays a critical role in connecting people with their food and in supporting the financial success of the state’s agricultural producers.

Mr. Newhouse concluded his remarks by identifying the need for policies that enable farmers to continue to be successful, and by thanking NOSB for its continued efforts to protect organic integrity.

Clarification on NOSB Decision-Making
NOSB chair Tracy Miedema reviewed the Board policy on decisive votes. Citing NOSB’s Policy and Procedures Manual, she stated that, “As specified in OFPA, two-thirds of the votes cast at a meeting of the board at which a quorum is present shall be decisive of any motion [§2119(i)]. Following Robert’s Rules of Order, all abstentions will be recorded as such and will not be included as part of the total vote cast. Similarly, all Board members who recuse themselves due to conflicts of interest, or are absent, shall be recorded as such and their votes will not counted towards the total number of votes cast. Both abstentions and recusals will be considered in order to establish a quorum.”

Additionally, Miedema reviewed the number of votes needed to qualify as a decisive vote, which she identified as follows: 

Recommendations and Decisions

Corn Steep Liquor

Background
Corn Steep Liquor (CLS) is a byproduct of the corn wet milling process. This material has been considered non-synthetic in the past by stakeholders including accredited certifying agents (ACAs) and the Organic Materials Review Institute (OMRI). It has been used as a non-synthetic input mostly in liquid fertilizer formulations for organic crop production. CSL was recently reevaluated by OMRI using the NOSB’s 2005 clarifications regarding the classification of synthetic and nonsynthetic substances and concluded that CSL should be classified as synthetic based on the use of sulfur dioxide during processing.

In an action memorandum dated April 23, 2010, NOP requested that NOSB review the process for CLS concerning its classification as synthetic or non-synthetic as an input for crop production. Based on the results of a technical review received by NOSB in February 2010, the Crops Committee (CC) presented a majority recommendation to classify CSL as synthetic based on the use of a non-allowed synthetic sulfur dioxide, used in the corn wet milling process. The majority recommendation of the CC asserted that sulfur dioxide breaking disulfide bonds during the steeping process, prior to the lactic acid fermentation, made the resulting CSL synthetic, and that a significant amount of sulfur dioxide remained in the final product.

The minority opinion, by contrast, stated that the NOSB should determine Corn Steep Liquor (CSL) to remain classified as nonsynthetic, given that “There was no evidence indicating that that the identity—that which makes the subject in question unique in its behavior, character, or function—of corn steep liquor as used is any different with or without SO2 as a processing aid. The behavior, character and function of the two are indistinguishable and on that basis alone, CSL remains non-synthetic.”

At the Fall 2010 NOSB meeting, the motion to vote on the CSL recommendation was withdrawn on the basis that new information on CSL had come to light. The current recommendation proposes that CSL produced via the traditional countercurrent corn wet milling process be considered non-synthetic and therefore be allowed for use in organic crop production. The recommendation reflects the majority of the Crops Committee’s conclusion that the use of sulfur dioxide during processing stops the fermentation process (a biological process) and prevents putrefaction, but does not cause chemical change that would render CSL synthetic.

Discussion
Comments on this recommendation fell largely into two camps, echoing the thoughts expressed in the majority and minority opinions. Those supporting the recommendation argued that while sulfur dioxide is used in the production of CSL, its use does not change the identity of CSL. Therefore, CSL should be classified as nonsynthetic because it has not been chemically changed according to the NOSB definition of “chemical change.” By contrast, those opposing the recommendation argued that the use of sulfur dioxide breaks disulphide bonds during the steeping process, thereby forming new chemicals and rendering CSL synthetic.

Relevant Comments
Dragan Macura (AgroThrive, Inc.): "Sulfur dioxide does break disulphide bonds under certain laboratory conditions, but these conditions do not exist in industry.”

Jay Feldman (NOSB member): “When the minority put CSL through the Decision Tree, we saw breaking of protein matrix, breaking of disulfide bonds, and the formation of new chemicals.”

Lianna Hoodes (NOC): “The use of sulfur dioxide makes clear that CSL is a synthetic.”

Gwendolyn Wyard (OTA): “OTA urges this Board to respect and support the decision of the 1995 Board and their classification of cornstarch as nonsynthetic. CSL is produced using the same process as corn starch and in 1995 Richard Theuer and his committee asked the same questions that are being asked today.”

Decision
The motion to classify CSL as a non-synthetic was not decisive. Five Board members voted yes, 6 voted no, 1 abstained, and 2 recused themselves. As a result, CSL remains allowed for use pending future NOSB determination.

 Chlorine Materials Annotation – Crops and Handling

Background
Chlorine compounds are the most common equipment and food contact sanitizers used in the food processing and handling and are recognized by the FDA as being appropriate for their intended use. They are also common disinfecting agents for farm equipment and tools. The health and environmental hazards associated with its manufacture and use are well researched and are mitigated through worker protection protocols, Good Manufacturing Practices, and oversight by local, state and federal agencies. The organic farming community, pre-NOP certification programs, and past NOSB decisions have determined that—coupled with these mitigating features—the proven efficacy and reliability of these chlorine materials in support of food safety concerns outweighs the risks.

That said, the annotation limiting the use of chlorine presently noted in §205.601(a) (2) and §205.605(b) do not align with a November 1995 NOSB recommendation on chlorine materials. The recommendation stated that chlorine materials should be allowed for use in organic crop production, organic food processing, and organic livestock production with the following annotation:

“Allowed for disinfecting and sanitizing food contact surfaces. Residual chlorine levels for wash water in direct crop or food contact and in flush water from cleaning irrigation systems that is applied to crops or fields cannot exceed the maximum residual disinfectant limit under the Safe Drinking Water Act (currently 4mg/L expressed as Cl2).”

This annotation was crafted to acknowledge that levels of chlorine permitted in municipal drinking water were considered acceptable for organic food production and handling. The language used in the proposed NOP rule published in March 2000 did not include the terms “indirect crop or food contact” and “in flush water … that is applied to crops or fields.”

The language used under §205.605 (handling uses) only mentions use in disinfecting food contact surfaces, leading some handlers to question whether chlorine could be used in direct food contact. The NOP responded in the preamble of the final rule (65 FR 80548, 80616, December 21, 2000) which stated that the use of the term “residual chlorine” referred to the chlorine that was present in water when it exited the facility as effluent.

In 2003, NOSB stated: “The Organic Foods Production Act is not designed to function as a waste water regulation. Instead, it is a regulation designed to protect organic integrity. As such, processing operations must demonstrate compliance with the chlorine annotation by monitoring the chlorine content of the water which is in direct contact with organic products, not the wash water which is discharged from the facility.”

In December 2010, the NOP issued draft guidance clarifying the use restrictions of chlorine materials in organic production and handling. On review and consideration of this draft guidance, informed by public comment and review of a new TR provided by the NOP (supplied for Crops Committee Sunset review), and with respect to the change in NOSB Policy and Procedures Manual to allow for annotation changes during Sunset, the Crops Committee decided to recommend a change to the annotation to chlorine materials for their listing under crop production and handling.

The current recommendation for Crops includes a Sunset vote to relist as well as a vote on an annotation change. The Handling recommendation, however, only includes a vote on an annotation change; the Sunset vote to retain the listing occurred at the Fall 2010 meeting.

Crops
Discussion
NOP views this as a clarification of current uses. A few commenters expressed concern about the inconsistency between the crop and handling annotation. The annotation for chlorine used in handling allows for direct food contact at the necessary FDA levels to disinfect and sanitize organic products provided the use is followed by a rinse. Direct applications of chlorine in the field and/or during post-harvest operations on the farm were discussed, as was the need for the same language to be used in the Crops and Handling listings. The Board also plans to look at modifying the chlorine listing for livestock as well, but at next meeting.

Decision
The following amended annotation was recommended:

For pre-harvest use, residual chlorine levels in the water in direct contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act. For disinfecting or sanitizing equipment or tools or in edible sprout production, chlorine products may be used up to the maximum labeled rates.

NOP views this as a clarification of current uses. Board plans to look at modifying livestock chlorine listing as well, but at next meeting.

The motion passed to relist chlorine with the above annotation; a second vote to relist chlorine with its existing annotation also passed.

Handling
Discussion
A few commenters raised concerns about requirements listed in the proposed annotation to follow the use of chorine materials with a potable water rinse, given that methods other than rinsing (referred to as “intervening steps” in the revised annotation below) could be used.

Additionally, Miles McEvoy noted that NOP has published draft guidance on chlorine, and that final guidance will be coming out shortly. There was also Board discussion about aligning the Handling and Crops annotation for chlorine materials with the livestock annotation for this material.

Decision
The following amended annotation change was recommended:

Chlorine materials (calcium hypochlorite, chlorine dioxide, and sodium hypochlorite) may be used up to maximum labeled rates for disinfecting and sanitizing food contact surfaces. Chlorine materials in water used in direct crop or food contact is permitted at levels approved by FDA or EPA for such purpose, provided there is an intervening step in place sufficient to ensure chlorine concentration in residual water coming into contact with organic ingredients or products does not exceed the maximum residual disinfectant limit for the chlorine material under the Safe Drinking Water Act.

Chlorine in water used as an ingredient in organic food handling must not exceed the maximum residual disinfectant limit for the chlorine material under the Safe Drinking Water Act.

Nutrient Vitamins and Minerals

Background
In 1995, the NOSB recommended to the Secretary of the USDA that nutrient vitamins and minerals appear on the National List as a class or category of allowed synthetic materials. The board also recommended that the class of allowed materials not be static, but be inclusive of materials that had received independent assessment and recognition as supplementing the human diet or providing support for optimal health. When the National List was proposed by the Secretary, the following annotation appeared that was not part of the 1995 board recommendation:

 National List §205.605(b): Nutrient Vitamins and Minerals, in accordance with 21 CFR 104.20, Nutritional Quality Guidelines for Foods.

In April 2010 the National Organic Program requested that the NOSB reevaluate their recommendation for nutrient vitamins and minerals, currently codified under 205.605(b), in the Sunset process and define the scope of permitted vitamins, minerals, and nutrients. The NOP’s evaluation was requested in order to clarify the scope of the current annotation. The NOP specifically asked that the NOSB consider the following:

Are the “nutrient vitamins and minerals” specified within 21 CFR 104.20 aligned with the 1995 NOSB Recommendation? If not, are there substances that should be prohibited or additional substances that should be allowed?”

“Materials required or allowed by law for the purpose of enrichment, supplementation or fortification of foods, including infant formula, and materials the use of which is supported by the FDA or the Institute of Medicine of the National Academies.”

Sodium Nitrate

Background
Sodium nitrate was originally reviewed by Johnson, Spencer, Sachs, and Jeffrey, in 1994/5. The Crops Committee (CC) at that time determined it to be non-synthetic. The NOSB then determined that this material is unacceptable for use in organic crop production, voting it down 4-9-1 on April 27, 2005. A subsequent NOSB vote on November 1, 1995 prohibited sodium nitrate with exception as specified in annotation--Prohibited unless use is restricted to no more than 20% of crop’s total nitrogen requirement. This percentage was a common restriction found in CCOF and other private party standards prior to the implementation of the NOP. In the previous Sunset vote on November 17, 2005, the CC voted 5-0 to relist and the NOSB voted 14-0 to relist.

 The current listing for this material is as follows:

§ 205.602 (g): Sodium nitrate—unless use is restricted to no more than 20% of the crop's total nitrogen requirement.

With no action, sodium nitrate would Sunset from § 205.602, which would result in unrestricted use. Removal of the annotation would result in complete prohibition of the material. Relisting as is would result in maintaining the status quo. As such, the Crops Committee put forth two proposed recommendations – one to relist sodium nitrate § 205.602(g) without the annotation and one to relist sodium nitrate § 205.602(g) with the current annotation: “—unless use is restricted to no more than 20% of the crop's total nitrogen requirement” - in the event that there is an unforeseen impediment to implementing the first recommendation.

Discussion
Several comments were made on this subject. In general, those opposing re-listing with the current annotation cited sodium nitrate’s incompatibility with organic agriculture, while those supporting re-listing without the annotation cited the absence of effective alternatives and the negative effect that prohibiting the material’s use would have on the production of certain domestic organic produce items during winter months. Additionally, several of those supporting sodium nitrate’s relisting pointed out that no new information about the material is available; therefore, previous Board decisions to list the material should be upheld.

Relevant Comments
Gerald Davis (Crystal Organic Farms): “The complete prohibition of this material will limit organic produce production in the U.S. in winter months.”

Emanuel DeMarez (SQM): “Sodium nitrate is critical to the viability of organic produce production in the U.S.”

Bob Anderson (OTA): “Decisions made by NOSB impact international trade.”

Tina Ellor: “We are not looking at sodium nitrate in terms of equivalency.”

Decision
The motion to re-list sodium nitrate without an annotation, thus prohibiting its use, passed by a vote of 12 to 2, with 2 members recusing themselves. A second vote to re-list the material with its current annotation also passed by a vote of 12 to 2, with 2 members recusing themselves.

Animal Handling, Transit, and Slaughter

Background
The Livestock Committee presented a discussion document on handling, transport, and slaughter at the October NOSB 2010 meeting. Based on the feedback it received on that document, the Committee developed the current recommendation, which calls for the addition of a new section, § 205.241, titled “Humane Handling, Transport and Slaughter,” the language of which reflects current industry standards in practice due to separate animal welfare certification programs, which are verified by their party audits. The only additional proposed regulatory language included in this recommendation is intended to guard against slaughter plant abuse of newborn calves. Together, this language aims to move towards a comprehensive animal welfare program in certified organic operations.

Discussion
Comments on this recommendation ranged from support for its intent to unify and codify acceptable handling, transit, and slaughter practices permitted within the organic system to rejection of its application of a single set of metrics to the diverse farming systems that exist within organic agriculture. Concerns were also raised by some commenters that the proposed standards would unduly burden small operations by increasing costs and paperwork, and therefore discourage such operations from pursuing and maintaining organic certification.

Relevant Comments
Ashley Swaffar (Arkansas Egg Company): “Certifying transporters is like certifying a tractor to cut hay.”

Jackie Von Ruden (MOSA): “We are concerned that the slaughter requirements could eliminate small plants.”

Mabell Rivas (Pennsylvania Certified Organic): “The animal welfare recommendations represent improvement, but more time is needed to collect comments on them.”

Decision
After many requests from the Board and the public to take this recommendation back to committee, the decision was made by the Livestock Committee Chair to withdraw it from the voting docket and continue work on it.

Stocking Rates

Background
Following the passage of its November 2009 Animal Welfare Recommendation, the Livestock Committee recognized the need to require adequate space for animals to exhibit their natural behavior during the non-grazing season or during times of temporary confinement. The current recommendation aims to refine the 2009 recommendation and consolidate it with the Livestock Committee’s recommendations on stocking density and humane handling, transport and slaughter. To that end, the current recommendation contains several defined terms, language clarifying sections 205.238 and 205.389, and a series of tables outlining stocking rates and minimum indoor and outdoor space allowances for different types of livestock.

Discussion
As with the discussion about the animal handling, transit, and slaughter recommendation, comments on this recommendation ranged from support to criticism on its assignment of specific numerical outcomes. Those who supported the recommendation indicated the importance of having clear, unified performance standards to both producers and certifiers. By contrast, those who opposed the recommendation felt that a single set of performance metrics failed to take into consideration regional variations (i.e. climate) that affect stocking rates and farmers’ ability to determine which stocking rates best serve the animals on their individual farms. Additionally, concerns were raised that the proposed standards would unduly burden small operations by increasing costs and paperwork, and therefore discourage such operations from pursuing and maintaining organic certification.

Relevant Comments
Ed Maltby (NODPA): “There is a crisis in dairy farming due to excessive regulations.”

Joseph Ward (Iowa Organic Association): “Creating hard-fast rules across all farming situations is an error.”

Bob Beauregard (The Country Hen): “We are concerned about the risks associated with having the birds on soil, including disease and exposure to predators.”

Michael Cox (Arkansas Egg Company): “The Board needs to finalize its recommendation on animal welfare. Lax standards create a market in which people exploit loopholes and still get the bulk of the marketplace.”

Beth Unger (CROPP): “Come back in the fall with a revised document that is based on more public comment. We need to get more input on this to be sure we don’t hurt small family farms.”

Decision
After many requests from the Board and the public to take this recommendation back to committee, the decision was made by the Livestock Committee Chair to withdraw it from the voting docket and continue work on it.

Evaluation of Materials Review Organizations

Background
A number of organizations currently provide materials review services to producers and certifiers. At least one of those organizations is an independent organization that is not an Accredited Certifying Agent or under any NOP oversight. At least one other materials review organizations is a formal subdivision of an ACA, and many ACAs provide some material review services to clients on a formal or informal basis.

On January 18, 2011, the NOP Deputy Administrator requested the participation of the NOSB in developing a clearer NOP policy on the oversight of such organizations. In response, the CACC developed the current discussion document, which notes that “there is a clear need for more uniform and consistent policies governing material review services,” and that a number of challenges exist to creating such policies. The document also outlines several potential oversight models, as well as a list of questions for the organic community regarding the need for more consistent policies and the form that such policies should take.

Discussion
Very little discussion was had on this recommendation. CACC chair Joe Dickson noted, however, that much written public comment was submitted on this topic, and that the Committee had not had a chance to go through it all. As such, the Committee would like more input from other certifiers that conduct material reviews and maintain lists.

Relevant Comments
Pat Kane (ACA): “All forms of programs that review materials should be under scrutiny.”

Next Steps
The CACC will review public comment on this discussion document and come back to the Fall 2011 meeting with a recommendation.

Classification of Materials – Update and Proposed Guidance

Background
At the November 2009 National Organic Standards Board (NOSB) meeting, the NOSB passed a recommendation on Classification of Materials. The recommendation included several “Next Steps,” that the NOSB felt were required in order for the recommendation to be implemented. The primary further work required of the NOSB was development of a Guidance Document that the various stakeholders (e.g., Accredited Certifying Agents, committees of the NOSB, National Organic Program personnel) could use when classifying materials. At the April 2010 NOSB meeting, the Joint Materials and Handling Committee presented a draft Guidance Document for public input. It was clear from that public input that the guidance document needed more work.

At the same April 2010 NOSB meeting, the NOSB passed an addendum to the definition of chemical change that the NOSB had recommended at the November 2009 NOSB meeting (shown as the underlined sentence):

Chemical Change An occurrence whereby the identity of a substance is modified, such that the resulting substance possesses a different distinct identity (see related definition of “substance”). Processing, as defined in §205.2, of agricultural products using materials allowed on the applicable section of the National List (i.e., §205.601 for crops,§205.603 for livestock and §205.605 / §205.606 for handling), does not result in chemical change as it applies to classification of materials.

• The draft guidance document accurately reflected the November 2009 NOSB recommendation
• Separate guidance documents for crops, livestock and handling inputs are needed
• Examples of crops and livestock material and how they would be evaluated need to be included
• Agreement with the committee that further clarification was needed in determining whether materials contain a “significant” amount of a synthetic input in the final material.

In September 2010, the National Organic Program (NOP) responded to the NOSB recommendations of November 2009 and April 2010. In general, the NOP’s comments aligned with those received in public comment at the April 2010 meeting. Additionally, the NOP did not support the addendum to the definition of chemical change.

Taking into consideration public comment from the last NOSB meeting and the response they received from the NOP in September 2010, the Materials Committee developed the current discussion document, which offers an update on their work. Key points of this document include:

• A motion to rescind the April 2010 recommendation that added a second sentence to the definition of chemical change;
• Creating guidance that will show that chemical changes generated during processing methods allowed in OFPA or National List materials do not render materials synthetic;
• A motion to accept proposed guidance that a significant level of a synthetic substance in the final material means a level exceeding any applicable regulatory limits, where in effect for the material being classified, and a level without any technical and functional effects in the final material; and
• Clarifying that the classification of a material is a separate evaluation step for a material from the evaluation of whether use of the material is consistent with organic practices.

Discussion
In general, there was support for revising the definition of chemical change to delete the second sentence that was added at the April 2010 NOSB meeting. By contrast, considerable disagreement emerged, particularly amongst the Board, surrounding the issue of significant vs. insignificant levels and the line at which the distinction between such levels should be drawn. Jay Feldman, for example, argued that the Board has a statutory responsibility to review synthetic materials, regardless of the level at which they are present in a given substance. On the other hand, Katrina Heinze and Tracy Miedema argued that while it may be desirable to review materials that are present at any level, doing so is not practically feasible since changing technology results in ever-changing levels of detectability.

Relevant Comments:
Katrina Heinze (NOSB member): “Detectability is difficult to execute in the real world; it is a chase to the bottom.”

Jay Feldman (NOSB member): “The law makes clear that we must review synthetics; it does not say at what level.”

Gwendolyn Wyard (OTA): “In regards to significant & insignificant, we support the direction of the majority to base allowable levels on applicable regulatory limits and the lack of a technical or functional in the final product. This was the language originally recommended by the 2005 NOSB, incorporated into the 2006 NOP Framework Document, and then supported by the MWG in their 2009 presentation. We do however respectfully request the NOSB further the guidance by detailing the applicable regulatory agencies and examples of limits that would be used for crops, livestock and handling.”

Decision:
The motion to rescind the April 2010 recommendation that added a second sentence to the definition of chemical change passed unanimously (14-0). However, the motion to accept proposed guidance on the meaning of significant/insignificant failed by a vote of 9 yes, 6 no. Without a decisive vote, the committee will need to issue another recommendation at the Fall 2011 meeting.

NOSB Vice Chair and Policy Development Job Descriptions

Background
It was noted by members of the Policy Development Committee (PDC) and the board in Fall 2010 that the Policy and Procedures Manual (PPM) is not clear as to whether the maintenance of the PPM is the ultimate responsibility of the PDC or the NOSB Vice Chair (VC).

Section II of the PPM describes the responsibilities of the NOSB Vice Chair:

Vice Chair
The Vice Chair shall act in the absence of the Chair. The Vice Chair shall also be responsible for maintenance and upkeep of the Policy and Procedures Manual.

Section IV of the PPM describes the responsibilities of the Policy Development Committee:

Policy Development Committee (PDC)
The Policy Development Committee makes draft recommendations for consideration by the Board to provide guidance, clarification or proposed standards of Board operations, policies and procedures. The PDC maintains the content and updates to the NOSB Policy and Procedures Manual and New Member Guide. The PDC occasionally works with other committees to develop joint recommendations where policy issues are involved. These two sections thus assign responsibility for maintenance and upkeep of the PPM to both the VC and the PDC.

The participation of the Vice Chair in the maintenance of the PPM serves the interests of the Executive Committee in the smooth and effective operation of the overall board. However, the PDC is charged with matters of internal board policy, and the PPM clearly also falls within this sphere. In consideration of these equally important interests in the maintenance of the PPM, the Policy Development Committee recommends that the responsibility be shared collaboratively between the PDC and the NOSB VC. Specifically, it calls for the following amendments to the PPM:

Vice Chair
The Vice Chair shall act in the absence of the Chair. The Vice Chair shall serve as a member of the Policy Development Committee, and work collaboratively with the PDC’s members on the also be responsible for maintenance and upkeep of the Policy and Procedures Manual.

Policy Development Committee (PDC)
The Policy Development Committee makes draft recommendations for consideration by the Board to provide guidance, clarification or proposed standards of Board operations, policies and procedures. The PDC maintains the content and updates to the NOSB Policy and Procedures Manual (in collaboration with the NOSB Vice Chair) and New Member Guide. The PDC occasionally works with other committees to develop joint recommendations where policy issues are involved.

Discussion
Very little discussion was had on this recommendation.

Decision
The motion to accept to change in language regarding the role of the Vice Chair in the maintenance of the PPM passed unanimously (14-0).

Procedures for Completing Committee Recommendations

Background
During the NOSB Fall 2010 Meeting, procedural questions arose over the prerogative of a Committee to withdraw a proposed recommendation. Withdrawing a recommendation is not an uncommon practice, occurring at least once during the same Board Meeting. However, in this case, the majority of the Board objected to the action of the Committee.

In subsequent discussions, it became obvious that the Policy and Procedures Manual (PPM) needed clarification on the subject. The Policy Development Committee thus proposed amending Section V of the PPM to read as follows:

Revision of Section V, PPM: Procedures for Completing Committee Recommendations.

Developing committee recommendations follows these broad steps:

1. The committee prepares a recommendation or discussion document as agreed to in the committee work plan (see p. 32 PPM).
2. The recommendation or discussion document is posted for public comment.
3. Public comments are considered by the committee when making recommendation to the Board.
4. Prior to an official vote at the Board meeting, the committee may withdraw its recommendation.
5. Once presented, the Board takes action on the committee recommendation.

Note: all language following #4 on p.20 of the PPM remains unchanged and should be included.

Discussion
Very little discussion was had on this recommendation.

Decision
A motion to accept revised language to Section V of the PPM regarding the development of committee recommendations passed unanimously (14-0). Revised language for #5 was included and is as follows:

“The committee can withdraw its recommendation, based on the approval of this action by the majority of the members of the committee. Once, presented, the Board votes on the committee recommendation.”

Update from Flavors Task Force
Co-chairs Gwendolyn Wyard and Julie Weisman provided an update on the work of OTA’s Flavors Task Force, which was assembled in response to an October 2010 NOSB recommendation calling for such a task force and a December 2010 NOP memorandum advocating that an informal industry group convene to develop a flavors recommendation.

The Flavor Task Force that has since been assembled is comprised of 12 members and has met once a week since February 18th, 2011. The group completed its first round of work and requests that the treatment of natural flavors is added to the Handling Committee’s work plan for the Fall 2011 NOSB meeting. In the meantime, the Task Force will continue its work and plan to deliver a complete presentation at the Fall meeting.

The Flavor Task Force's comments can be found at regualtions.gov Comment Number AMS-NOP-11-0014-3182.

Committee Work Plans

Handling Committee
-9 205.605 petition items
-6 205.606 petition items
-6 205.605(a) Sunset items
-2 205.605(b) Sunset items
-nutrient vitamins and minerals
-chlorine materials annotation recommendation
-collaboration with industry Flavor Task Force

Materials Committee
-classification of materials
-primer on materials evaluation checklist
-collaboration with Crops Committee on sulfur dioxide
-aquaculture materials
-develop a list of materials-related research projects
-orphan materials that were tabled but never reviewed
-orphan materials that were reviewed but tabled
-improve materials review process

Crops Committee
-Petitioned materials
-Sunset 2013 materials
-transition plan for tetracycline and streptomycin
-collaboration with Materials Committee on sulfur dioxide
-monitor inerts
-commercial availability

Certification, Accreditation and Compliance Committee
-develop a recommendation on materials review organizations
-risk-based unannounced inspections
-inspector qualification assessment
-pesticide residue testing
-retailer certification
-use of processing aids in 100% organic products

Livestock Committee
-revise animal welfare recommendations (include outcome-based standards for each species, and develop species-specific guidance documents with certifiers)
-guidance on animal welfare
-omnivore diets

Policy Development Committee
-NOSB leadership/membership transition
-transparency/availability of committee minutes
-add administrative team to PPM
-conflict of interest

Materials Decision Summary (download pdf)

New Petitions

Crops Committee

* i) As plant disease control (12) Tetracycline (oxytetracycline) for fire blight control in apples and pears only until October 21, 2014.

Handling Committee

Sunset Review Items

Crops Committee

 *For crops, a motion to re-list chlorine with the following annotation passed:

For pre-harvest use, residual chlorine levels in the water in direct contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act. For disinfecting or sanitizing equipment or tools or in edible sprout production, chlorine products may be used up to the maximum labeled rates. A vote to re-list chlorine “as is” for crops also passed.

The motion on a proposed annotation change for chlorine under handling was withdrawn and not voted upon.

**11) Streptomycin, for first blight control in apples and pears, only until October 21, 2014.


Handling Committee Sunset 2012

Other Business
At the end of the meeting, NOSB member Jennifer Taylor circulated a 4-paragraph letter to the Board asking them to sign it in response to public testimony expressing a desire to keep GMOs out of the organic system. The exact contents of the letter was not made available to the public during the meeting, but was, according to Ms. Taylor, intended to get a “sense of the Board” related to GMOs, and to affirm that the Board acknowledged the public’s concern about the presence of GMOs in organic.

Some members of the Board indicated that they were willing to sign the letter. Others, however, expressed discomfort in being asked to sign a statement that they had not had time to review. Board chair Tracy Miedema proposed a compromise, whereby the GMO issue would be taken up by the Executive Committee at the Fall NOSB meeting. The Board voted unanimously (14-0) on a motion to accept this proposed action.