2007 11-28 consolidated comments

Comment on the Compliance, Accreditation, and Certification Committee

Recommendation on Multi-Site Operation Certification

November 28, 2007

(slightly revised from earlier version)

Synopsis

This recommendation represents a framework for revising the way group certification is approached, which fully complies with the requirements of OFPA and NOP 205.403.  It is intended as a guidance document, rather than proposing a rule change.  OTA aimed to develop a recommendation that would not be prejudicial with regard to scale of operation or location (domestic or foreign).  Detailed protocols for verifying compliance with the existing rule are under development.  Elements of this framework include:

1.  Group Certification through a Single Organic System Plan 

A group of similar producers or producer/handlers would constitute a single certified operation, which operates under a single Organic System Plan, controlled through a single Internal Quality System.   Each producer or participant manages a sub-unit or plot, which may be part of a production unit of the group certified operation.  A very simple group might consist of a single agricultural production unit, while a more complex group might include multiple agricultural production units.

2.  Agricultural Production Unit

Every production unit, facility and site must be inspected annually under NOP 205.403.  This recommendation identifies a range of criteria which may be used to designate a collection of sub-units as a single production unit, which must be approved by the ACA.  Each sub-unit may be managed by an independent contractor or by personnel of the certified operation. Any production/handling facility is considered a single production unit that must be inspected annually.

3. Internal Quality System (IQS)

Every certified operation must have some system for internal monitoring and control in order to ensure that all activities are compliant with the NOP.  In certification of a group, the IQS serves as an internal training and extension service to ensure that all participants understand the Organic System Plan, as well as an internal surveillance system to ensure that all participants are implementing the plan as required.

4. Inspection Protocols

This recommendation calls for developing detailed protocols for the annual on-site inspection of a group certified operation.  The inspection must focus on a thorough audit of the functioning of the Internal Control System through document review, interviews with managers responsible for various aspects of the OSP, and examination of every production unit, facility and site.

Inspection of a production unit that includes multiple participants and sub-units should entail examination of a statistically significant sample of the sub-units, based on a risk-assessment methodology in combination with random selection of a certain percentage of sub-units.  Protocols for sample selection and methods for verifying compliance with all applicable sections of the regulations will be specified in detail.

The following recommendations represent OTA's Task Force consensus and OTA's current position:

1. The agricultural production group must be organized as a single legal business entity, such as an association or cooperative.

2. Each agricultural production unit (definition and guidance below), must be inspected as part of the required annual on-site inspection under the NOP.

3. Plots or sub-units within a production unit must be within geographic proximity, but need not be contiguous. 

4. Individual members may be split or parallel operations, including plots intended for self-provisioning.  However, if prohibited substances are used on any portion of that operation that adjoins an organically managed plot, that portion should be considered a higher risk for loss of organic integrity and factored into the choice of sub-units to be included in the organic inspection.

5. Only products marketed through the certified group operation may be represented as "organically produced."

Background

The consensus of the OTA Group Certification Task Force, and OTA's current position, is that the problems raised by the appeal decision of October, 2006 concerning the compatibility of the Community Grower Group model with the NOP can be resolved without requiring an amendment to the regulations.  Specifically, the appeal decision from AMS, dated October 27, 2006, states that "the establishment of an internal inspection system as a proxy for the mandatory on-site inspections by the certifying agent or approved contract inspector is not permitted under the NOP regulations."  This recommendation accordingly is responsive to the original problem and seeks to clarify that an Internal Quality System that is consistent with the NOP regulations does not establish an internal inspection system as a proxy for mandatory on-site inspections under the NOP.

The recommended approach is to consider a multi-site operation as a single certified entity, which may have separate production units, all of which function under a single Organic System Plan (OSP).  The Internal Quality System (IQS) is thus analogous to an internal Quality Assurance department.  The task of the certifying body is to verify that the IQS is functioning as required to ensure that all members are following the OSP, and that non-compliant subunits are appropriately addressed.  The internal staff does not operate in lieu of or as proxies for the organic inspector.  However, systems must be in place to ensure that personnel have appropriate expertise, training and performance reviews.  The organic inspector would conduct an on-site visit to each production unit, as required under the NOP, and use a range of methods to verify that the IQS is being followed consistently, including complete inspection of a meaningful sample of plots or subunits.

In the case of producer groups, individual plots are analogous to individual farm fields that are all following the same crop rotation, and that need only be verified as to boundaries and location by the organic inspector.  Proposed definitions of terms such as "site," "facility," "inspection," and "production unit," not currently included in the NOP, will help in providing guidance for the certification of multi-site entities in compliance with the NOP.

Although OTA has not reached a definitive conclusion concerning the question of whether group certification should apply to multi-site production/handling operations as well as to producers, we acknowledge that the recommendations should be as nonprejudicial as possible with respect to scale, type of operation (farmer or farmer/handler), and domestic versus foreign.

Group Certification Benefits and Risks:

The benefit of group certification to producers who are organized to pool their organic production under a single business entity is clear:  The costs of obtaining individual certification, including annual on-site inspection by a qualified third party inspector, are significantly less than if each small plot had to be individually inspected each year-costs which would be prohibitive for these producers.  There are other benefits of such group management, such as improved education and sharing of information that may not occur without the incentive of having to maintain organic compliance.  The biggest risk of such a group involves the potential for "one rotten apple" to spoil the barrel.  The group's Internal Quality System must be well enough enforced to identify and remove from the group producers or products that are not in compliance.  If, for example, a producer uses a prohibited substance by mistake, the IQS must have mechanisms to identify and segregate that producer's crop before it is commingled with the rest of the group.  The annual organic inspection will focus on how effectively the IQS is being enforced, and the group's failure to follow its own IQS can result in suspension or revocation of the group's certification.  Guidelines for best practices of an Internal Quality System, including enforcement mechanisms, are outlined in the Appendix (not yet drafted).

OTA Recommendations:

The OTA Group Certification Task Force used the 2002 NOSB Grower Group Recommendations as the basis for developing these recommendations.   We also consulted various IFOAM materials concerning smallholder group certification, including accreditation criteria for certifiers who provide such services.  The discussion of each recommendation (numbered items in bold) includes a comparison with these foundational documents, and a rationale for any divergence. 

1. OTA Recommendation: The agricultural production group must be organized as a single legal business entity, i.e., an association or cooperative.

Comparison to foundation documents (NOSB): In 2002 the NOSB recommended that a group "must be managed as a legal entity under one central administration that is uniform and consistent."  This would seem to preclude considering producers who are associated only by contract with the same exporter.   However, the exporter itself could conceivably be the certified entity, with each production unit of the crop in question consisting of multiple plots.

2. OTA Recommendation: Each agricultural production unit (definition and guidance below), must be inspected as part of the required annual on-site inspection under the NOP.

3. OTA Recommendation: Plots or subunits within a production unit must be within geographic proximity (definition/criteria for this term to be developed), but need not be contiguous. 

Comparison to foundation documents (NOSB/IFOAM):  Neither the NOSB nor IFOAM limit group members to geographically contiguous subunits. IFOAM suggests that "there must be homogeneity of members in terms of geographical location, production system, size of the holdings and common marketing system."  The NOSB recommends that a group "must utilize centralized processing, distribution, and marketing facilities and systems."  This would presume enough proximity for producers to readily collect their crops in one location after harvest. Geographical proximity is a relative term, as transportation systems in some parts of the world can entail lengthy trips to get from one field to another, even if they share a common border. Proximity obviously does not require contiguity, but more specific guidance should be developed for the term "geographical proximity."

4. OTA Recommendation: Individual members may be split or parallel operations, including plots intended for self-provisioning.  However, if prohibited substances are used on any portion of that operation that adjoins an organically managed plot, that portion should be considered a higher risk for loss of organic integrity and factored into the choice of sub-units to be included in the organic inspection.

Comparison to foundation documents (NOSB/IFOAM):  Neither the 2002 NOSB recommendation nor IFOAM make any specific stipulation about split operations.  However, the NOSB's recommendation that "the crops and farming practices must be uniform and reflect a consistent process or methodology, using the same inputs" would imply that non-organic production, or even production of a different organic crop, would eliminate a producer from eligibility.  

IFOAM calls for "homogeneity of members in terms of production system," but adds a footnote that "there is consensus that these should be very similar, but in some situations farmers produce different secondary cash crops.  In that case a qualified decision has to be made by the certification body as to whether there is sufficient homogeneity."    The NOSB recommended that participation in the group be "limited to producers who sell all of their organic production through the group."  This does not presume that non-organic production would not take place on the same farm.  However, if any individual field or plot, whether on the same North American farm or in a foreign smallholder group, is adjacent to an area where prohibited substances are being applied, the concern for organic integrity might dictate that this field or plot be inspected annually.  The Appendix will provide guidance for how the certifier should evaluate this decision, based on a risk assessment model.

We should additionally assume that any non-market crops produced by a group member (i.e., self-provisioning) are not a concern for this discussion, unless prohibited substances are being applied adjacent to a plot that is under organic management.

5. OTA Recommendation: Only products marketed through the certified group operation may be represented as "organically produced."

Comparison to foundation documents (NOSB/IFOAM):  The question of whether all organic products must be sold through the group is related to the fact that individual sub-plots are not certified, except as they are part of the certified operation, and so products sold to other markets are not covered by the group's certification.  Therefore, by definition only products marketed through the group operation can be represented as "organically produced."

Definition of Terms and Guidance for Certifying Agents

OTA's Task Force developed the following definitions as part of its guidance for interpreting these recommendations:

Internal Quality System means a documented quality assurance system formally designated by an operation to implement methods to monitor and ensure compliance by each production unit, including any sub-units of which it is comprised, with the applicable regulations.  The internal quality system must be described in the operation's organic system plan.

Production Unit means the portion of an organic operation where products are produced and/or handled by producers, including any sub-units located within geographic proximity. A production unit, including any sub-units located within geographic proximity, operates under the operation's organic system plan, and is managed through an internal quality system to ensure compliance with all applicable provisions of the regulations.  Each production unit within a production or production/handling operation has defined location, practices, management and/or products.

Sub-Unit means a smaller discrete portion of a production unit, such as a field, plot or distinct processing area.

Guidance for Designation of a Agricultural Production Unit

The Production Unit defines and describes the portion of each certified operation that must be physically inspected on an annual basis in order to satisfy the requirements of 205.403(a).  The definition and guidance clarify how a production unit is identified, what must be inspected, and how the extent of the inspection is determined.  The certified entity must identify and describe each production unit in its organic system plan, along with a rationale for designating it as a production unit.  The rationale must be approved by the certifier.

Criteria for designation of a group collection of sub-units as a production unit include all of the following that are applicable (note that forthcoming "best practices" guidance will elaborate on each of these):

*Geographic proximity (needs further definition and guidance);

*Common input supply;

*Common coordination of product collection through a central facility;

*Common personnel responsible for managing operations, providing extension services, monitoring and enforcing the functioning of the internal quality system (level of management control *demonstrated);

*Unique product or variety, time of harvest, or other distinguishing characteristics;

*Common production methods or production/handling practices; and

*Common soils, water source, slope, topography or other physical features.

Only products identified in an operation's organic system plan may be sold or represented as organic.  Products that are not marketed through the certified entity may not be sold or represented as organic.

Guidance for Certification and Inspection of a Production Unit

The annual on-site inspection must include detailed examination of a meaningful sample of the sub-units that comprise any production unit, as determined by the certifying agent.  Selection of the sample to be examined during a given annual on-site inspection must be based on an assessment of the organic system plan, the identified organic control points, the risk of contact with prohibited substances and/or commingling with non-organic product, and the internal quality system in place in the operation. At least 25% of all sub-units should be inspected in any given year, and any subunit that includes a production/handling facility must be inspected annually. 

The inspector must describe the extent of the production unit that was examined in the report submitted to the certifying agent, along with the rationale for identifying the portions of the production unit examined. 

Following are other factors that must be considered when determining which sub-units to include in the sample (additional information on risk assessment to be incorporated into forthcoming "best practices" guidance):

*Verification that previous non-compliances have been adequately corrected;

*Identification of any sub-unit as a new entrant or any concern about the level of understanding of the regulations by parties responsible for crop or facility management;

*Identification of any sub-unit that directly adjoins land that is treated with prohibited substances; and

* Elapsed time since the sub-unit was last inspected.

Appendix: Guidance for Internal Quality System Best Practices

Detailed recommendations concerning guidance for Group Certification Internal Quality System Best Practices will be developed and submitted to the NOSB for its next meeting.  This guidance will include specific criteria for designation and identification of a production unit; criteria for including new participants, plots or sub-units; risk assessment guidelines for selecting samples of sub-units for initial and subsequent on-site inspections; management and personnel qualifications; education and training of participants; documentation; internal compliance and sanctions; and NOP compliance and enforcement.

Documents Consulted:

NOSB Recommendation, "Criteria for Certification of Grower Groups," adopted October 20, 2002.

International Accreditation Forum, Inc. (IAF), "IAF Guidance on the Application of ISO/IEC Guide 62:1996, Annex 3, Multisite Certification/Registration,"  April 12, 2000.

IFOAM, "Smallholder Group Certification: Compilation of Results," March, 2003.

ISO/IEC 17021: "Conformity Assessment-Requirements for bodies providing audit and verification of management systems," First edition 2006-09-15.  

Pyburn, Rhiannon. "Final Report on Internal Quality Systems and Management Systems: Public Summary," Social Accountability in Sustainable Agriculture (SASA), August 3, 2004.

Comment on the Joint Materials and Handling Committees

Discussion Document on the Definition of Materials

We appreciate the thoughtful consideration given by the Joint Materials and Handling Committee to the complex issues surrounding the definitions of "agricultural inputs," "agricultural product," "ingredient," "nonagricultural substance," "nonsynthetic (natural)," "processing," and "synthetic" within the NOP regulations.  Some of these issues relate to fundamental questions about the meaning of "organic" within the context of the OFPA.  They are also central to some of the problems associated with how this meaning is communicated to the general public.  The opportunity to collaborate in this discussion is welcomed.

Please refer to our comments related to the definition of many of these terms, including "synthetic," that were submitted to the NOSB on 8-15-05 and 4-18-06.

1. Problem Statement: 

OTA disagrees that an agricultural substance can be processed beyond a point at which its agricultural nature ceases to exist.  If a substance originates with an agricultural product, then it could have been organically produced.  We believe that the more organically produced products are used, the better it is for farmers, the trade, and the planet. 

2.  The National List: 

We have no comment on this section.

3.  Historical Perspective: 

It is important to point out that there was minimal input from processors or handlers in the drafting of the OFPA.  In the nearly two decades since that time, both food processing technologies and our understanding of organic production systems have developed considerably.  For good reason, therefore, the OFPA provides only a broad framework for organic processing requirements. 

We accordingly support a broad interpretation of "consumption," as used in the OFPA's definition of "Agricultural products," to include personal care products, fiber, etc.  We also note that the phrase "otherwise manufacturing" in the OFPA's definition of "Processing" indicates a broad allowance for the use of additional manufacturing methods within the organic handling sector.

Regarding the definition of "Nonagricultural substance" in the Final Rule, OTA supports either ending the definition after the word "mineral" or substituting the phrase "mineral derived substance" for "bacterial culture" and ending the definition at that point.

4.  Discussion

4.1 Agricultural and Nonagricultural: 

OTA agrees that the definitions given in the Final Rule are confusing and inconsistent, and points out that the need for distinguishing between agricultural and nonagricultural ingredients arises from confusing and inconsistent provisions in the OFPA concerning substances that may or may not be used as ingredients in processed organic products. 

We support deleting the examples in the definition of Nonagricultural substance, and agree that the concept of "unrecognizable" is not useful.  As the Committee rightly points out, it would be extremely difficult to come up with objective criteria for "unrecognizable."  It therefore makes most sense to dispense with the idea that a product manufactured from agricultural raw materials, through a process that does not involve use of a prohibited synthetic substance, is no longer an agricultural substance.  Further, there are no processing methods, other than irradiation, extraction with volatile synthetic substances, or use of other prohibited synthetic processing aids, specifically prohibited by the NOP in Section 205.105.

We suggest that the idea that substances can be processed "excessively" to a point "beyond which their agricultural nature ceases to exist" confuses the issue.  While concerns about food products that may undergo excessive processing are understandable in light of the preferability of whole foods, the definition in question refers to substances used as ingredients in organic processed products.  Such ingredients, if they are not themselves organically produced, can constitute only a very small fraction of a product that carries an organic label, and thus their processing methods have little impact on the organic quality of the product.  Many consider the use of highly processed substances, which may be fractions of whole foods having questionable nutritional value, to be undesirable.  However, if such a substance is used in an organic processed product for some functional attribute (e.g., as an emulsifier or thickener), then it should be derived from an organically produced raw material.

Old Versus New Paradigm:

We appreciate the effort to develop a different model for classifying substances, but believe that the "new paradigm" does not go far enough.  We would favor removing any substance that is of agricultural origin from the possibility of being classified as "nonagricultural" or "synthetic" solely on the basis of how drastically it has been altered from its raw state, since any processing of agricultural substances always results in a chemical change.  We contend that any substance whose origin is a raw agricultural product or any living organism is by definition nonsynthetic. 

Therefore, we suggest that only substances that are not of agricultural origin, or not derived from living organisms, should be classified as "synthetic" if they have been created through a chemical process.  Thus, only substances derived from minerals and other mined substances, including petroleum derivatives, could be classified as "synthetic."  We believe that this approach would move the entire process closer to the historical basis of organic standards.

OTA agrees that the first mention of "chemical process" in the OFPA's definition of synthetic refers to chemical processes between synthetic substances, and also to a chemical process between a synthetic substance and an agricultural substance (including an ingredient).  It is entirely consistent with our position that products that are of agricultural or living origin, if combined with a prohibited synthetic substance such as a chemical reagent, would then be designated as synthetic.  We note that this concerns only the classification of substances that are considered for inclusion on the National List, not consumer ready products that may include them as ingredients under the NOP.  We would also point out that, much as the definition of "organic" is complex because it refers to a production process and not a measurable product quality, so too is the definition of "synthetic" similarly process-based.  In most cases, there is no way to determine analytically whether a given substance is synthetic-you have to know how it was made.

4.4  Life and Agriculture:

OTA disagrees that some life may not be agricultural. If life is cultured, it should be considered agricultural for the purpose of organic production, which is an ecological production management system.  Yeast growing on organic corn substrate, managed ecologically, is just as much a part of an ecological production management system as corn growing in the soil, much as livestock fed organic feed and managed ecologically are part of an organically managed system.  The designation of yeast as an agricultural product would not affect livestock feed requirements, since yeast is clearly not a feed and should be considered a feed supplement.

5.  Conclusion:

We would suggest changing the Definition of Materials Decision Tree to reflect the comments outlined above.  Page 1 would accordingly change as follows:  The first question should read, "Is the substance or product in question derived from a plant, animal or other living organism and marketed in the US for human or livestock consumption?"  Since such a product could not become nonagricultural, it would not then run through page 2.  The only possible outcomes would be either: a) an agricultural product that could be petitioned for inclusion on 205.606 if not derived from organic raw ingredients; or b) a prohibited synthetic substance, by virtue of the raw agricultural ingredients having been combined with a synthetic substance in the course of its manufacture.

Page 2 of the Definition of Materials Decision Tree is intended to determine whether a substance that has been identified as a nonagricultural product should be classified as synthetic or nonsynthetic.  We would delete the first box, which refers to substances derived from microorganisms, and begin with the question, "Is the substance derived from a naturally occurring mineral source that is not further processed?"  The second question would be, "Is the substance formulated or manufactured by a chemical process from a substance extracted from a mineral, plant, animal or living organism?" This part of the chart needs further refinement, however, in consideration of the unanswered questions concerning the interpretation of "synthetic process."  We suggest that a product derived from a living organism would only become designated as synthetic if its manufacture involved combining the raw material with a synthetic substance that is not on the National List at 205.605(b).

The Joint Committee has done well to identify areas of confusion, and we would only add that this confusion continues to pose challenges to consistent enforcement of the rules as well as to public understanding of the issues surrounding organic production and handling.  We agree that the matter should not be taken up piecemeal, and thank you for your efforts to seek clarity.

Other Comments

Policy Development Committee Recommendations

OTA has no comment concerning proposed revisions of the Board Policy Manual or New NOSB Member Guide. 

Joint Policy Development, Crops, and Livestock Committees Recommendations

We welcome the clarification that the Joint Committee recommendations offer on the crucial subjects of Certification of Operations Involved in Crops Research and Guidance on Temporary Research Variances.  These recommendations are both thorough and thoughtful, and we fully support their adoption. 

We also suggest that additional guidance should be developed for the possibility of research that is conducted more informally, on a working farm.   In particular, Section B of the Guidance on Temporary Variance for Research refers to "principal investigator/research facility," and item 11 calls for a description of professional qualifications of key research personnel.  Organic agriculture involves highly site-specific practices, and many important innovations arise through experiments conducted by working farmers.  We believe that part of the intent of Section 205.290 was to allow farmers to undertake trials of techniques or varieties that may be well suited to their site, but that may be inconsistent with one of the applicable sections.  For example, a livestock producer might wish to run a trial of a livestock feed supplement that is not currently available as organically produced, but which may be encouraged to be organically produced if it is efficacious in the organic herd setting.

Handling Committee and Crops Committee Recommendations on Sunset Materials

OTA suggests that any substance being considered for Sunset Review should be approved to remain on the National List in the absence of specific comments presenting information in support of removing it.  We believe that many producers and processors who may use substances being considered under the Sunset Review provision might be unaware of the need to submit comments in support of continued allowance of these materials, and could be unduly penalized if a substance is removed from the National List simply because comments were not received to the effect that the substance continues to be necessary for organic production or handling.

Compliance, Accreditation, and Certification Committee Recommendation on Standard Certification Information

OTA thanks the CAC Committee for addressing the problems outlined in this recommendation, and supports the proposed rule change to require more consistent information to be listed on organic certificates.  We suggest that, if specific crops must be listed on a certificate, some attention should be paid to potential problems for organic producers when changes are made to the Organic System Plan.  For example, the annual on-site inspection may occur early in the season, and a plan calling for planting a specific summer crop may have to be changed.  Some mechanism for updating only the list of crops produced or products handled should be possible without having to issue an entire new certificate.

Compliance, Accreditation, and Certification Committee Recommendation on Commercial Availability Guidance for Certifiers

OTA appreciates the CAC Committee's work to provide additional guidance for ACAs in making determinations of commercial availability.   We believe that this recommendation will help make these determinations more consistent, and further encourage the development and use of organically produced seeds and minor ingredients.   We support the establishment of a data base of all ingredients and seeds for which allowances have been granted, with proper confidentiality safeguards.  We specifically applaud the inclusion of item #5, requiring operators to undertake proactive steps to generate the organic form of commercially unavailable organic ingredients, materials or seeds.

Finally, we wish to note that the criteria for approving a substance petitioned for inclusion on Section 205.606 of the National List should not require documentation of current commercial unavailability in organic form.  This determination is properly made by the ACA, and the availability of some ingredients may change too quickly to enable them to be put on the National List when faced with unanticipated market disruptions.

Livestock Committee Aquaculture Working Group Recommendation regarding Bivalve Molluscs

We are pleased that this recommendation is being put forward, and look forward to the opportunity for increased domestic organic aquaculture production.