The NOSB's recommendation is a welcome step towards clarifying the requirements that handlers must meet concerning use of nonorganic agricultural ingredients in organically labeled products. OTA has the following comments and requests for clarification concerning this recommendation:
General:
The NOSB has identified the determination of commercial availability as its focus for establishing a process for petitioning substances for inclusion on 205.606. However, OTA disagrees strongly with the need to establish present or potential commercial unavailability of an organic form of any substance in order for it to be included on 205.606. Responsibility for determining whether a given agricultural ingredient that is included on 205.606 is commercially available in organic form should remain the purview of the Accredited Certifying Agent.
Historically, the only determination that the NOSB has made in considering petitions for 205.606 has been whether or not the substance was agricultural. OTA urges the NOSB to follow this precedent. Further clarification is urgently needed concerning the definition of “agricultural,” as well as the identification of an “individual” agricultural product for inclusion on 205.606.
A. Amendments to “Information to be included in a petition”
OTA does not believe that most of the information requested in the current petition format is applicable to agricultural products. However, in the interest of expediting the process for submitting petitions we will advise our members to simply indicate “not applicable” in response to questions that relate to the impacts of a material on human health and the environment.
While we support the request for supporting information concerning recent and potential commercial unavailability of the substance being petitioned, OTA opposes the requirement for such information as a criterion for inclusion on 205.606.
A petition for 205.606 should additionally provide information showing that the substance being petitioned meets the definition of “agricultural product.” We also wish to reference our comment submitted in response to the NOSB Handling Committee’s recommendation of July 14, 2005 relative to “agricultural” and “nonagricultural” substances. We urge consideration of the inclusion of any living organism or its products in the definition of “agricultural” substances. Inasmuch as the OFPA includes “any non-plant life” in its definition of livestock, then yeasts, fungi and other single-celled non-plant organisms must be considered to be agricultural products that can be subject to the NOP. We also suggest that a product created by combining two or more agricultural ingredients to undergo a biological process must itself be considered to be agricultural.
B. NOSB review of petitions
In recommending an agricultural ingredient for inclusion on 205.606, OTA believes that the NOSB should also review the information concerning “all factors that may present a challenge to a consistent organic supply” of the product in question, in addition to current availability of organic substitutes in the appropriate form, quality or quantity needed to fulfill an essential function in a system of organic handling. This recognizes that substances may be considered based on potential limitations to supply.
Notwithstanding any information submitted concerning recent or potential commercial unavailability of an organic form of the substance in question, we again emphasize that this should not be considered an essential criterion for its inclusion on 205.606. A determination that a specific ingredient that appears on 205.606 is not commercially available in organic form must remain a case by case decision that is made by the Accredited Certifying Agent.
The Declaratory Judgment of the U.S. District Court for the District of Maine states: "...205.606 shall be interpreted to permit the use of a nonorganically produced agricultural product that has been listed in section 205.606 pursuant to National List procedures, and when a Certifying Agent has determined that the organic form of the agricultural product is not commercially available" (emphasis added). This language indicates that, since the question of whether it is "not commercially available" is still to be left to the certifying agent, review of petitions under 205.606 need deal only with the agricultural nature of the material.
C. Guidance for Accredited Certifying Agents
OTA supports the process outlined in this section, and would only suggest that Accredited Certifying Agents submit updates to the NOP of ingredients that have been granted allowances on a quarterly basis. We believe that this information would prove valuable as a means for potential suppliers of appropriate organic ingredients to supply information about the availability of such ingredients to the NOP or an Accredited Certifying Agent, with protection of confidential business information.
OTA shares the concerns expressed by many regarding misuse of the current allowance for the use of nonorganic ingredients in organic products. We fully support the implementation of strict guidelines for Accredited Certifying Agents in making determinations of commercial availability. We also wish to point out that Accredited Certifying Agents currently use the recommendations provided by the NOSB in April 2000 in making these determinations. In addition to the parameters identified by the NOSB, further guidance is needed in determining whether a given ingredient meets the definition of “agricultural,” and is thus subject to 205.606.
Further considerations and request for additional clarification:
In addition to commenting on the NOSB's recommendations on commercial availability, OTA has several concerns about the process for including materials on 205.606, and for implementing the new rules as ordered by the Court. We are accordingly requesting that the NOSB and the NOP address the following questions:
1. Identification of an “individual” substance: A petition has been submitted for the listing of “herbs and spices” as a single entry on 205.606. While the Court made it clear that ingredients must be individually listed, we have seen no indication of how an individual agricultural ingredient, as opposed to a category of agricultural products, will be defined. Must each individual type of herb and spice be listed separately? Will a manufacturer who uses 100 different spices have to submit 100 petitions? Must each different variety of an herb or spice be separately petitioned, so that lemon basil, thai basil, cinnamon basil, etc. each has a separate listing? Could basil oil be listed but not ground basil? Alternatively, FDA permits processors to list “herbs and spices” on an ingredient label, without further distinction. Might this argue for acceptance of this generic product as an “individual listing” on 205.606? Similar questions could be raised for categories of products such as soy products, corn products, essential oils, oleoresins, and so on.
2. Emergency Exemption: OTA urges the NOSB and the NOP to develop a proposal for implementation of the emergency exemption provision included in the 2005 amendment to the OFPA. We are encouraging our members to submit petitions for all minor ingredients that they are currently using in organic products that could potentially become unavailable in organic form. However, unanticipated disruptions to the supply chain, whether due to crop failures, natural disasters, Federally mandated spray programs or other market fluctuations, are bound to occur.
An example of such a scenario exists right now, as organic processors may be faced with unprecedented shortages of organic ingredients that were never previously in short supply. California, the largest almond producing state in the country, has experienced more rain this winter than it has seen in over ten years. The almond crop is currently just past bloom, orchards are filled with sitting water, and the outcome of the crop is uncertain. Many processed products include almonds and almond flavoring as minor ingredients, and manufacturers may be unable to obtain organic almond products at any price in the coming year.
In order to avoid undue disruption of the industry, priority should be given to implementation of the emergency exemption provision, with appropriate rulemaking and public comment procedures. While we appreciate public concerns about abridging the authority of the NOSB to review substances prior to their inclusion on the National List, such concerns must be balanced with the need to act more quickly than is possible through full NOSB review. Approaches that could be considered include requiring consultation with the NOSB Executive Committee prior to issuing a proposed rule listing any substance considered for emergency exemption. We also suggest that emergency exemptions not be granted for reasons of price.
3. Clarification of Stream of Commerce: OTA also requests that the NOSB and NOP provide clarification about the time line for compliance with the Court order mandated interpretation of Section 205.606. We understand that many certified operations have questions about the date certain by which no product may contain any non-organic agricultural ingredient that is not listed in 205.606. We are requesting clarification of the interpretation of the phrase “Stream of Commerce" when applied to ingredients in an organic product. The Court has ordered that “no non-conforming products may enter the stream of commerce after that date (two years from June 9, 2005).” Does this mean that an ingredient manufacturer can produce a product on June 8, 2007 that complies with the current version of the rules? Can this later be used as an ingredient in a processed product and still comply with the Court ruling?
OTA suggests that the interpretation of “stream of commerce” be made comparable to that applied to implementation of the NOP in October, 2002, with broad latitude for allowing products that were produced prior to the deadline to be used until the supply is gone.
Conclusion:
OTA thanks the NOSB, and the members of the Joint Policy Task Force, for their diligent efforts in clarifying the question of commercial availability. We anticipate a timely implementation of the new rules governing 205.606, and offer our full cooperation with the NOSB and the NOP in accomplishing this task. We wish to note that the inclusion of an agricultural product on 205.606 will not allow its use in a processed organic product unless an Accredited Certifying Agent determines that the product is commercially unavailable in organic form. OTA supports rigorous NOP oversight of the granting of such allowances.
