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May 4, 2009
OTA is pleased to take the opportunity to comment on the following items on the NOSB’s agenda:
FURTHER GUIDANCE ON A PEER REVIEW SYSTEM
We appreciate the NOSB’s effort to assist in clarifying Section 205.509 with reference to a Peer Review Panel. We would simply wish to point out that the intent of the provisions in Section 6516 of the OFPA for a Peer Review Panel relate to assisting in the review of applicants for accreditation, not for reviewing the performance of the NOP accreditation program, worthy as that function might be.
We also suggest that the provisions for a Peer Review Panel that were included in the first proposed rule might be examined and considered. This would create a group more akin to a Technical Advisory Panel that would provide independent evaluations of a candidate for accreditation, and would not be subject to the public disclosure requirements of a FACA committee. Non-governmental expert reviewers could also receive compensation for the extensive work that would be involved in such a review. We would additionally suggest that this process might only be required for first time accreditation applicants, and not used on an ongoing basis.
SEC. 2117. (7 U.S.C. 6516) PEER REVIEW OF CERTIFYING AGENTS.
(a) PEER REVIEW.—In determining whether to approve an application for accreditation submitted under section 2115, the Secretary shall consider a report concerning such applicant that shall be prepared by a peer review panel established under subsection (b).
(b) PEER REVIEW PANEL.—To assist the Secretary in evaluating applications under section 2115, the Secretary may establish a panel of not less than three persons who have expertise in organic farming and handling methods, to evaluate the State governing official or private person that is seeking accreditation as a certifying agent under such section. Not less than two members of such panel shall be persons who are not employees of the Department of Agriculture or of the applicable State government.
GUIDELINES FOR THE USE OF INERT ATMOSPHERIC GASES WITH PRODUCTS LABELED AND SOLD AS “100% ORGANIC”
We support the CACC’s recommendation to clarify the requirements for the “100% organic” label, and believe that use of inert atmospheric gases as packaging aids should not affect the organic status of the product.
RETAILER CERTIFICATION DISCUSSION
OTA appreciates the intent of the CACC’s discussion document seeking to explore approaches to providing consistent guidance and improved oversight of voluntary retail certification. The question of multi-site retail certification in particular must be approached with caution, however. During the previous public discussion concerning the CACC’s Multi-Site Certification document, the OTA Board expressed its opposition to considering retailer group certification, and instructed the OTA Group Certification Task Force to revise its recommendations to include only language pertaining to grower groups. There is some interest among OTA’s retail members in developing more consistent guidance for voluntary retail certification and in exploring the possibility of multi-site certification for retailers. However, any related guidance must be developed with great care to avoid any appearance of compromise to the rigor of the organic certification process.
Please note that OTA plans to establish an internal Task Force to update our proprietary Good Organic Retail Practices (GORP) manual in the coming year, and that this manual is intended to offer guidance on Best Practices for organic retailers, not serve as certification guidance. As this project moves forward we will be happy to work with the NOSB on sections related to retailer certification guidance.
PERSONAL BODY CARE STANDARDS DISCUSSION
OTA thanks NOSB for taking a helpful first step towards integration of Personal Care manufacturing into the NOP, and wishes the Board the best of luck in resolving the issues that have proved so difficult for so long. We hope that NOSB realizes that the term "cosmetics," as regulated under the Food, Drugs, and Cosmetics Act, does not include soaps, and that is the reason OTA has preferred the term “personal care,” which includes soaps. OTA stands ready to assist NOSB in any way we can.
Due to the widely diverging opinions about many of the issues related to organic personal care products, OTA recommends forming a Task Force to address the questions we have identified here, along with any other issues that may arise in the course of this endeavor.
Before considering a recommendation for a rule change, we therefore urge the NOSB to charge a Task Force with making recommendations about the following issues and questions related to inclusion of cosmetics and personal care products within the NOP:
* The NOSB’s discussions and recommendations around clarification of definitions of “agricultural,” “nonagricultural,” “synthetic,” and “nonsynthetic” may have a major impact on whether certain ingredients in personal care products can be acceptable under the NOP. For example, should a product such as soap, which may have been derived from an organic agricultural substance be labeled as “organic” or “made with organic” under the NOP if it meets the definition of synthetic?
* What are acceptable processing methods for organic personal care products? The potential breadth of organic personal care product lines seems to be a matter of contention, with OTA members divided on how many commercially viable products can be made under the current rule compared with other scenarios or standards. OTA supports the current NOP policy of allowing certified handling operations to process allowed substances in order to produce an organic product (e.g., in the production of sodium lactate). On this basis, the phrase "otherwise manufacturing," as used in the definition of “processing,” might enable a broad enough line of product to meet both manufacturer and consumer expectations.
* Another item that needs further discussion is the calculation of the percentage of organic content in personal care products, for which soap provides an excellent example. OTA notes that there are many fine organic soaps produced by several OTA members, so that this question already has been answered for practical purposes, but suggest that the NOSB at least consider, and if possible affirm, the decisions now being made by certifiers.
* Could cosmetic ingredients produced through processes such as hydrogenation, which may not be suitable for foods, be annotated to specify the allowable processes? It is not clear whether Section 205.605 can and should cover any and all materials or processing aids for cosmetics, similar to the treatment of pet foods. The possible wording of annotations is a related question, as some 205.605 materials are used for personal care products, and materials may be petitioned for use in organic handling without including an annotation specifying a particular product or type of product for which they would be permitted. Since NOSB has recommended that Section 205.606 include separate sections for human food and pet food, a similar division might be considered for personal care products. OTA further urges that a Task Force identify materials for possible petition to the National List, as was done in the pet food recommendation. While we recognize that proposing large numbers of synthetic substances for use in personal care products might cause some concern among consumers, some new synthetic substances might be needed for this sector. We hope that the NOSB will explore this subject in detail.
* If the regulation is amended to refer to cosmetics, why not include herbal and nutritional supplements, textiles, and other non-food agricultural products?
* Would it be adequate for the NOP to simply revise its policy statement on Cosmetics, Body Care Products, and Personal Care Products of April, 2008 to state that “Personal care products that are labeled as ‘100 percent organic,’ ‘organic’ or ‘made with organic’ must be compliant with the NOP”?
* Because cosmetics and personal care products are not generally refrigerated and may not be used for months after they are manufactured, use of substances specifically as preservatives is often advisable. The Task Force might revisit NOSB’s processing criteria and make a recommendation concerning an allowance for relatively benign personal care ingredients that are used primarily as preservatives.
* How would NOP enforce its label on products that are not within its jurisdiction, absent a formal agreement with FDA? How would sanctions be imposed on noncompliant cosmetic manufacturers or brand names that include the word “organic”? We again offer our support for the NOP to negotiate an MOU with FDA to address organically labeled cosmetic and personal care products as expeditiously as possible.
* What would be the impact of inclusion of cosmetics under the NOP on voluntary organic cosmetic standards? OTA suggests that NOSB request public comment on the current amount and kinds of organic personal care sales (such as products with ingredients certified to non-NOP standards) in order to begin examining the potential effects of regulation on the current market. Related to this is the question of a proposed timeline for implementation.
BIODIVERSITY GUIDANCE RECOMMENDATION
We applaud the NOSB for giving careful attention to the subject of biodiversity in organic production systems. The various statements of principles that have been adopted by the NOSB are valuable guidance, but we also would like to see the regulations strengthened to explicitly require organic producers to protect and enhance biodiversity on their operations. For example, the section on crop rotation in the first proposed rule was originally titled “Biodiversity and Crop Rotation,” and included requirements for introducing biodiversity into both annual and perennial cropping systems.
We certainly support the modest guidance proposed as a step in the right direction. The only minor changes we suggest relate to the additional verbiage suggested to be added to the NOSB materials review criteria, as follows:
Category 1: Biodiversity is clearly a part of the environment, and adding it to question 1 is not useful. Questions 6 and 7 offer more specific opportunities to emphasize biodiversity. Question 6 could be amended to ask if there are adverse biological and chemical interactions in the agroecosystem, including effects on biodiversity. Question 7 should add “wildlife” to say “Are there detrimental physiological effects on soil organisms, crops, livestock OR WILDLIFE?”
Category 3: Adding the words AND BIODIVERSITY to question 2 might imply that biodiversity is something separate from organic farming and handling. This is the particular question that the early definition of a “system of organic farming and handling” was meant to address. Addition of this definition to the NOP would establish the principle of biodiversity as integral to a system of organic farming and handling, and necessitate evaluation of the impacts on biodiversity not only of substances under review by the NOSB, but of any practice used in an Organic Compliance Plan.
SOIL-LESS GROWING SYSTEMS DISCUSSION ITEM
We believe that the principles of an “ecological production management system,” as outlined by previous NOSB statements of principles, would imply that any living organism could be cultivated for consumption by humans or animals within such a system. While most agricultural systems are indeed soil based, an ecological production management system would not preclude aquatic, hydroponic, or enclosed microbiological, insect or fungal cultures from being considered organic. Soil fertility is the foundation of all soil-based systems, but non-soil-based systems can potentially be certified as organic.
We believe that it is not a matter of concern if some requirements are not applicable to a given operation, as long as producers comply with those rules that do apply to their operation. A livestock producer, for example, need not demonstrate compliance to the requirement for access to pasture in the case of non-ruminants. Similarly, the possibility that a hydroponic or other soil-less production system could function within the limits of NOP compliance for use of inputs should not be foreclosed.
ANIMAL WELFARE GUIDANCE AND STANDARDS DISCUSSION
OTA supports the continued evolution of organic standards to incorporate more explicit rules concerning the humane treatment of animals in organic systems. The suggestions made by in this document represent a modest first step. We additionally note that the proposal would identify outcome-based criteria, such as body condition scoring, for evaluating compliance with the standard. This is a sensible approach that should also be applied to other aspects of the regulations.
We also agree with the need for more detailed guidance material for producers and certifiers, and believe that such material should not be included in regulations. As new information and data about the most appropriate tools and methods for managing livestock in a humane manner is developed, it can readily be incorporated into a program manual without necessitating the lengthy process of regulatory revision.
There is a similar need for guidance that is comprehensive and updated periodically in every other aspect of the program, and we would encourage the NOP to work towards developing such a program manual as soon as resources permit.
AQUACULTURE BIVALVES DISCUSSION
It appears to us that the AWG has adequately responded to each of the five concerns identified by the NOSB Livestock Committee in its response of March 17th. We urge the NOSB to move forward with its recommendations concerning organic standards for bivalves.
DEFINITION OF MATERIALS DISCUSSION DOCUMENT
OTA and OTA members have actively participated in the lively Materials Working Group (MWG) discussions of the past year, and we appreciate the complex and nuanced nature of issues concerning definitions of materials. We have the following concerns about the direction indicated by the current NOSB discussion document, and will continue to offer all possible assistance in resolving the questions it raises.
III. Current Direction of the Committee
We disagree with the conclusion reached in the final paragraph of page 2, concerning the question of whether an agricultural raw material that is processed so that it becomes synthetic is still agricultural. The MWG did not recommend a classification of “agricultural synthetic,” and while the realm of potential certified organic synthetic products might represent a small fraction of organic agriculture, several approaches have been suggested to address this issue. Among these is the option of requiring that all handling substances included on the National List in Sections 205.605 and 205.606 be subject to commercial unavailability of an equivalent organic form, regardless of their classification.
Applying this option would also eliminate the need for the NOSB to concern itself with whether or not a given substance had its origin in an agricultural raw material. As noted by the MWG in its earlier recommendation, the current NOP definition of “nonagricultural” which bases the distinction on whether a substance is “recognizable” is confusing and arbitrary. Classifying egg white lysozyme as nonagricultural due to its extraction and purification (which may be intended to mean “concentration”) brings us back to the question of recognizability—is it nonagricultural simply because it no longer resembles a chicken egg?
Additionally, we believe that any handling substance, whether of agricultural or nonagricultural origin, that is manufactured through methods that meet the NOP definition of processing should not be classified as synthetic. This includes the mixing of an agricultural product with a synthetic substance that is on the National List as a handling material.
We share the NOSB’s concern about the amount of time and resources that have been devoted to resolving the question of how to classify microbiological materials or the products of microbiological fermentation. We believe that the MWG presented several acceptable options for making it possible for such products to be certified organic under the NOP, of which the classification of microbes as agricultural is only one. As mentioned above, a requirement that any handling substance on the National List be subject to commercial unavailability of an equivalent organic form would eliminate the need to categorize these substances as agricultural or nonagricultural. We do not believe that addressing the yeast problem through an annotation on 205.605(a) that specifies permissible processing methods and inputs for its production, as suggested by the NOSB, is workable. The NOP has previously noted that such annotations would be difficult to verify or enforce.
We would also prefer that this commercial availability requirement be applicable to livestock feed. The concern about the requirement that 100% of agricultural ingredients in livestock feed must be organic can be addressed as suggested in the 2008 MWG discussion document on the question of agricultural and nonagricultural under Option C. This would entail revision of the livestock feed requirements to be consistent with those for products for human consumption, by permitting the use of up to 5% nonorganic agricultural products as livestock feed, subject to the commercial availability restriction.
We believe that microbiological production can be considered agricultural, and although additional standards for such production might be helpful, do not think this is essential. There currently exist certified organic products of microbiological fermentation, including yeast and alcohol. The applicability of these production methods to other types of microbiological products, such as enzymes, yogurt and cheese cultures, would need to be examined in greater detail.
IV. Request for Public Comment
Our primary objective in seeking clarification of the classification of materials on the National List is to facilitate the expansion of organic producers, land under organic management, and the range of organic products on the market. Clarification will reduce or eliminate significant uncertainty in the crop, livestock and handling input industry, and potentially make more organically compatible tools available to organic farmers and handlers. We believe that this clarification will also help reduce consumer uncertainty about the meaning of the organic label, and are confident that our suggestions would not compromise the integrity of the organic label in any way. Rather, we believe that greater clarification will make the whole system of organic certification and labeling more robust and consistent.
We note that the request for public comment asks about upholding or meeting organic principles in relation to the definitions in question, and would point out that there are no organic principles stated in either the OFPA or the NOP for reference. The NOSB has previously adopted two principles statements, one of which was drafted by the NOP staff and subsequently used as the basis for defining “a system of organic farming and handling” in the first proposed rule. However, this definition was not included in the final rule.
Reference to an “ecological production management system” in these organic principles statements would imply that any living organism could be cultivated for use or consumption by humans or animals within such a system. While most agricultural systems are indeed soil based, an ecological production management system would not preclude aquatic, hydroponic, or enclosed microbiological, insect or fungal cultures from being considered organic.
Finally, we suggest that the NOSB initiate a public discussion of the intent of the definition of “synthetic” provided in the OFPA, as outlined in the public comment submitted to the NOSB by two OTA members, Grace Gershuny and George Kalogridis. While OTA is not endorsing the suggestions made in that document, we share the authors’ concerns about organic consumers’ perceptions of “synthetic chemicals,” and believe that the questions raised merit serious consideration and public debate.
OTHER ISSUES
USDA Seal
We understand that the NOP has expressed its intention to revise the rules governing the color of the USDA organic seal, and wish to encourage them to do so. Several members have expressed confusion and frustration at having to change labels in order to comply with the current color specifications.
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