April 30, 1998
The Honorable Dan Glickman
Secretary of Agriculture
U.S. Dept. of Agriculture
14th St. & Independence Ave., S.W.
Washington, DC 20250
Dear Secretary Glickman,
On behalf of the Board of Directors and staff of the Henry A. Wallace Institute for Alternative Agriculture, I want to express our sincere gratitude for your sensitive leadership in facilitating the development of comprehensive standards for the production, handling, processing, and sale of organically produced food and fiber. We are grateful to you for allowing the various interested parties sufficient time and opportunity to comment on the Department's proposed rule. In particular, the Department's Web page was a most welcome feature of this participatory process, allowing for a full public debate on these critically important matters.
With regard to the matter of public comment, I'm happy to attach the Wallace Institute's comments, Beyond the "Big Three," on Docket #TMD-94-00-2. Our staff has devoted a considerable amount of effort to the preparation of these materials, which we hope will be useful to the Department as it considers "next steps" in the rule-making process.
Having been involved directly in the Department's initial efforts in 1979 to begin the process of investigating the character and potential of organic farming systems, I want you to know, on a personal level, how gratifying it is to the organic farming community to see the Department's continuing commitment to this increasingly important production alternative. As you may know, the Department's landmark study on alternative farming systems, entitled Report and Recommendations on Organic Farming (1980), was regarded by the organic farming community as a watershed statement by USDA on the positive potential contributions of organic farming to American and world agriculture. Reactions to the report were widespread and intense. Approximately 40,000 copies were distributed by request, making it one of the most sought-after reports ever published by the U.S. Dept. of Agriculture. Interest within the international community was also remarkable: the report was translated eventually into seven foreign languages. Domestically, although controversial, the report's scientific focus added enormously to organic farming's credibility within agricultural science, policy, and production agriculture circles.
Viewed in the context of this nearly 20-year perspective, including passage of the 1990 Organic Foods Production Act, the Department's current commitment to the eventual promulgation of comprehensive organic standards acceptable to the organic farming community, and that community's growing consumer, environmental, and scientific constituencies, helps to fulfill the expectations envisioned in these earlier activities. We welcome and applaud your efforts.
Finally, I want you to know that the Henry A.Wallace Institute stands ready to work with you and others at the Department as this historic effort to elevate and support organic farming unfolds. We look forward to working with you in the months and years ahead. Thanks again, and best wishes—
Sincerely,
I. Garth Youngberg, Ph.D.
Executive Director
Table of Contents
Executive Summary
The proposed National Organic Program is fatally flawed.
We urge the Secretary to re-propose the National Organic Program based on the recommendations of the National Organic Standards Board (NOSB) which were written following extensive public dialogue between organic, environmental, and consumer groups.
We entitle this Docket comment "Beyond the Big Three" because the proposed National Organic Program (NOP) contains numerous and complex issues beyond the headline-grabbing concerns of genetic engineering, ionizing radiation, and biosolids. We look forward to working with the staff of the U.S. Department of Agriculture to redesign this important program. Specifically, we urge:
This document includes:
About the Henry A. Wallace Institute for Alternative Agriculture
The "Wallace Institute" is a nonprofit, tax-exempt, membership research and education organization established in 1983 to encourage and facilitate the adoption of low-cost, resource-conserving, economically-viable, and environmentally-sound farming systems.
The Wallace Institute works directly with government agencies, education institutions, producer groups and other organizations to help shape agriculture policy. The Wallace Institute's efforts are aimed at advancing the scientific and educational goals of alternative agriculture. The Wallace Institute is governed by a grassroots Board of Directors which includes farmers, scientists, educators and policy analysts, and maintains a small professional staff. Its various advisory groups include prominent practitioners, scholars and scientists. It is supported by memberships, donations and grants from individuals, corporations and foundations.
The Wallace Institute has several publications; many are found at: www.hawiaa.org. The American Journal of Alternative Agriculture, a peer-reviewed quarterly, provides a scientific forum for exchanging and disseminating research findings related to alternative farming systems. Other efforts include: "Alternative Agriculture News" (a monthly newsletter), special symposia, policy studies reports and occasional paper series.
About the contributors to this commentKathleen Merrigan, Senior Analyst, runs the Capitol Hill Office of the Wallace Institute. In 1995, she was appointed to a five-year term on the National Organic Standards Board. Previously, Kathleen was staff to the U.S. Senate Agriculture Committee, working for Chairman Patrick Leahy, and was responsible for drafting the Organic Foods Production Act of 1990.
Mark Keating, Policy Analyst, works in the Capitol Hill Office. Previously, Mark served as a North Carolina agricultural agent working on groundwater protection. He has 10 years of experience working with organic farms, orchards and CSAs.
Nessa Richman, Policy Analyst, is finishing a paper on trends in the U.S. market for organic and natural foods. Nessa worked from 1993-1995 with organic farmers and ranchers in Texas.
Dr. Kate Clancy, Director of the Agriculture Policy Project, has worked on organic processing standards since 1975, at the Federal Trade Commission, Syracuse University, and now at the Institute.
Dr. Dave Ervin, Director of the Policy Studies Program, is directing a project aimed at understanding the economics of organic production and marketing systems.
Dr. Garth Youngberg, Executive Director, established the Wallace Institute after leaving the USDA where he served as the USDA's first-ever Organic Farming Coordinator as well as team leader for the landmark 1980 USDA Report and Recommendations on Organic Farming.
Natural Resources Defense Council (NRDC) Endorsement
April 30, 1998
Eileen S. Stommes
Deputy Administrator
USDA-AMS-TMD-NOP
Room 4007-S, Ag.Stop 0275
P.O. Box 96456
Washington, DC 20090-6456
Docket Number TMD-94-00-2
Dear Ms. Stommes,
The Natural Resources Defense Council (NRDC) endorses "Beyond the Big Three" and adopts these comments, for the purpose of the docket, as our own.
NRDC is a non-profit environmental membership organization with over 350,000 members and contributors nationwide.
Sincerely,
| Jennifer Curtis Consultant to NRDC | Jacqueline C. Hamilton Senior Project Attorney |
Sustainable Agriculture Coalition (SAC) Endorsement
April 30, 1998
Eileen S. Stommes
Deputy Administrator
USDA-AMS-TMD-NOP
Room 4007-S, Ag.Stop 0275
PO Box 96456
Washington, DC 20090-6456
Docket Number TMD-94-00-2
Dear Ms. Stommes,
The Sustainable Agriculture Coalition endorses "Beyond the Big Three" and adopts these comments, for the purpose of the docket, as our own.
The 12 member organizations of the Coalition are the Center for Rural Affairs, Illinois Sustainable Agriculture Society, Iowa Citizens for Community Improvement, Kansas Rural Center, Land Stewardship Project, Michael Fields Agricultural Institute, Minnesota Food Association, National Catholic Rural Life Conference, Northern Plains Sustainable Agriculture Society, Sierra Club Agriculture Committee, The Minnesota Project, and the Wisconsin Rural Development Center. Together, the Coalition's members represent thousands of farmers and conservationists across the Midwest and the Great Plains.
Sincerely,
Ferd Hoefner
Washington Representative
Implementation Timetable
The Secretary requests comment (Questions #1,#2, and #3) on appropriate implementation timetables for the proposed program. We take this opportunity to provide our recommendations on the next steps in the rulemaking process.
Almost all of the 150,000+ comments delivered to the Docket are highly critical of the Proposed Rules. We urge the Secretary, however, not to succumb to the temptation to withdraw the proposal and start anew. An unprecedented number of people and organizations have devoted themselves to analyzing and responding to the Proposed Rules. Their comments should be carefully cataloged, evaluated, and responded to in the Final Rules. To otherwise toss aside their comments in the process of withdrawing the Proposed Rules would anger citizens who have little extra time to reissue opinions on detailed government proposals. We recommend that the Department re-propose the National Organic Program following substantial revision. The re-proposed rules should indicate clearly that the public comment received between December 16, 1997 and April 30, 1998 will "count" and be responded to in the Final Rules. This will assure citizens that their earlier comment efforts were not in vain and furthermore, allow them to target subsequent comments to the newly proposed areas.
As the Department begins the task of drafting a re-proposal, we urge extensive interaction with the NOSB and organic agriculture advocates within the environmental, consumer, and farming communities. The Supplementary Information to the Proposed Rules states that the USDA "designed the proposed rule to be as consistent as possible with existing industry practices, while satisfying the specific requirements of the OFPA." Nevertheless, the Proposed Rules differ dramatically from industry norms, consumer expectations, and the mandates of the OFPA. The Department staff, while meaning well, did not succeed in meeting their aforementioned goals. The NOSB has requested guidance as to how the Board may best collaborate with the Department within the ex parte dictates of the Administrative Procedures Act; we hope that the necessary flexibility for greater partnership can be found. Organic standards have always evolved through extensive public dialogue and the acceptance of the National Organic Program, depends to some extent, on the ability of the USDA rulemaking process to mirror the transparent and participatory nature of state and private certification standard setting.
We recommend that the Secretary submit a re-proposal to the Federal Register by October 1, 1998. This should allow sufficient time for the Department to analyze the public comment and make necessary adjustments. We ask that the comment period on the re-proposal be no less than 90 days. This may seem excessively long, given the current comment effort. But it is necessary given the grassroots nature of the organic farming movement, the timing of harvest, and the numerous holiday interruptions at that time of year. Given this timetable, we would expect that Final Rules would be published in the Federal Register sometime in the spring of 1999, with the goal of final implementation in growing season 2000.
Now is not the time to move quickly ahead only to meet arbitrary deadlines. We urge the Secretary to take the time necessary time to develop a National Organic Program that wins the praise of the organic industry, and the environmental and consumer groups who worked so hard for passage of the Organic Foods Production Act of 1990 (OFPA).
The Secretary requests comment (Question #4) on the impact the proposed program would have on small entities. Our answer to this question is found under our discussion of fees and in the Regulatory Impact Assessment portion of this document.
The Secretary requests comment (Questions #5 and #6) on the electronic capacity of entities that would be regulated under the proposed program and the paperwork burden they would bear. Our answers to these questions are found in Appendix A, under the Paperwork Reduction Act.
Subpart A
Definitions
Section 205.12 Terms defined
General comments
The NOSB reviewed each definition in the Proposed Rules at the March, 1998 Ontario, California meeting. The Wallace Institute supports the NOSB analysis and we urge the Secretary to adhere to the Board's recommendations. We have also reviewed the extensive discussion of the definitions submitted to the Docket by the Organic Trade Association and find it to contain many useful recommendations. While we rely on these two documents for a comprehensive discussion of the definitions included in the Proposed Rules, we would like to elaborate on a few points.
At least one major omission appears regularly throughout the definitions: fiber products are excluded from organic production definitions. For example, the definition of livestock does not include animals raised for fiber production. We urge the Secretary to scrutinize these definitions to ensure that newly emerging organic crops such as fiber and aquaculture are encompassed by the Proposed Rules.
System of organic farming and handling
We raise no objections to the proposed definition as far as it goes. However, we support
additional language to acknowledge the environmental and ecological responsibilities attendant to organic agriculture. The Proposed Rules describe organic production and handling systems as if they existed without an ecological context. The practice of organic agriculture requires explicit recognition of the favorable as well as adverse environmental impacts associated with production. The assumption that farming can function in a vacuum independent of off farm consequences has been a major factor in discounting the heavy environmental damage resulting from conventional agriculture. The NOSB recognized agriculture's ecological responsibilities in its definition of organic:
Organic agriculture is an ecological production management system that promotes and enhances biodiversity, biological cycles and soil biological activity...The primary goal of organic agriculture is to optimize the health and productivity of interdependent communities of soil life, plants, animals and people.1
This appreciation for the holistic and integrated nature of organic systems of farming and handling needs to be extended to respect commercial as well as non-commercial species and resources. Ecological consequences including alteration of habitat, introduction or dislocation of species and environmental disturbance are valid criteria for organic certification guidelines.
Active ingredient in pesticide formulations
Active ingredient in any input other than pesticide formulations
Inert ingredient in any input other than pesticide formulations
Inert ingredient in pesticide formulations
Terminology found in the Proposed Rules concerning active and inert ingredients in pesticide and non-pesticide formulations draws upon the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). While adopting this framework would appear to provide a consistent rationale for evaluating materials, or at least those materials used in pesticide formulations, the FIFRA is no substitute for criteria in the OFPA. Under the FIFRA, a material, regardless of its toxicological affect or environmental impact, is classified as inert if it is not a primary active ingredient. Furthermore, the statute allows ingredients identified as active in one formulation to be inert in another.
To escape NOSB review of all synthetic materials as required in the OFPA, the Secretary has extended the definitions using the FIFRA to a variety of materials and material uses not intended under the FIFRA or the OFPA. We strongly object to this extension.
FIFRA-based classification of active and inert ingredients is also poorly suited for the review of non-pesticidal formulations. Active ingredients in these formulations are those which (1) become chemically functional parts of the system; (2) are labeled ingredients or food additives; or (3) are of significant consequence to the production, handling and integrity of an organically managed agricultural product. Materials which the USDA does not place in a category become allowable inerts for non-pesticidal production inputs such as fertilizers and foliar sprays. Regrettably, there is no pre-existing List procedure to even begin to evaluate the potential consequences of permitting use of these materials in organic production. Our confidence in these procedures was shaken when the USDA argued in the Supplemental Information that "we determined that a substance used to treat lumber that is used for such purposes as buildings, fences and trellises cannot be considered to be an active ingredient under our definition of an active ingredient." The willingness of the USDA to exempt from review the highly toxic materials associated with treated lumber is a poor reflection on the Department's ability to evaluate the health and safety implications of allowable synthetic inerts. We strongly recommend that every synthetic material - whether active or inert, pesticidal or not - under consideration for use in organic production be subject to NOSB review with appropriate Technical Advisory Panel input as needed.
Genetic engineering
Genetic modifications of organisms by recombinant DNA techniques
We believe that this definition of genetic engineering is outdated and does not adequately incorporate all currently available technologies. While the suitability of genetic engineering in organically managed systems is an area where the USDA has specifically requested comment, a more accurate and comprehensive definition of the term is needed to make the debate meaningful. An improved definition will also be needed to address very important issues of equivalency with international organic standards. We propose that the Final Rule adopt the definition of genetic engineering proposed by the NOSB:
Made with techniques that alter the molecular or cell biology of an organism by means that are not possible under natural conditions or processes. Genetic engineering includes recombinant DNA and RNA techniques, cell fusion, micro- and macro-encapsulation, gene deletion and doubling, introducing a foreign gene, and changing the positions of genes. It shall not include breeding, conjugation, fermentation, hybridization, in-vitro fertilization and tissue culture.2
Definitions for feed, feed additive, feed supplement and forage
Routine use of a parasiticide
The proposed definition is inadequate because it states that parasiticides cannot be administered without cause. But this produces too much leeway and will not be enforceable. We recommend adoption of the NOSB definition which prohibits "the scheduled regular or periodic administration of a parasiticide to an animal with or without cause."
Subpart B
Organic Crop and Livestock Production and Handling Requirements
Organic agriculture requires a fundamental commitment to soil building and other ecological enhancements. There is no such thing as 'organic by neglect.' An abandoned orchard untreated by synthetic pesticides, for example, would not qualify for organic certification. Historically, organic standards have required more — the orchard must be cared for, its trees pruned and its soil nourished. The comments in this Subpart are lengthy, but the complex science behind organic production requires no less.
Orders of preference
The Secretary requests comment (Question #7) on whether the establishment of orders of preference would impose an unnecessary burden on organic producers. Orders of preference are used for multiple practices in the Proposed Rules, such as determining proper manuring, nutrient and seed use and prevention and control of crop pests, weeds and diseases. While an orders of preference system may be novel to many USDA officials, such a regulatory approach is consistent with many state and private organic certification programs which delineate between "approved", "restricted" and "prohibited" practices. Indeed, the orders of preference system is among the most positive and commendable elements in the Proposed Rules.
We do not anticipate that an orders of preference system will prove onerous to producers. Under the current system of state and private certification, most producers welcome the approved, restricted and prohibited system because it provides the necessary flexibility to work with certifying agents in areas where improvements can and need to be made. It enables producers to make incremental improvements in their operations as they approach organic status and beyond certification. And it enable certifying agents to adjust certification requirements based on site specific needs. This conforms with our vision of a National Organic Program that allows producers and certifying agents to pro-actively determine how individual operations can best achieve and improve compliance with organic production standards.
Too much flexibility however, will create confusion and hardship for producers and certifying agents and potentially undermine the National Organic Program. In addition to providing a continuum of preferred practices as proposed, Final Rules should clearly distinguish between approved and restricted practices along that continuum of preferred practices. 3 The common understanding of restricted practices, which we use here, are those practices which deviate from standard approved practices but are approved by a certifying agent for specific circumstances, are consistent with the principles of a system of organic farming and handling, and are not prohibited under the OFPA. To engage in a restricted practice, a producer must first obtain the consent of a certifying agent. Certifying agents should be tasked with considering four conditions — commercial availability of a substance, environmental conditions, site- and product-specific circumstances and unanticipated or emergency situations — to determine when a restricted practice may be employed by a producer.4 Without designating certain practices as restricted, there will be no imperative for producers to improve on particular practices nor procedures for certifying agents to compel a more stringent alternative. An order of preference system without such designations could select for the lowest common denominator by providing the same reward - certification - to very dissimilar operations. For the sake of convenience or cost, producers could adopt the least stringent practice and make no additional effort to upgrade their operation. And certifying agents would lack the authority to challenge producers' choices from the range of allowable options.
The organic plan detailed in Section 205.205 is the best mechanism for producers and certifying agents to work together and develop mutually satisfactory management proposals. In drafting an organic plan, producers should be required to explain where they stand in the continuum of allowable practices and what, if any, measures they feel capable of making to move higher in the order. They should justify decisions to employ restricted, as opposed to approved practices, within the context of the resources at their disposal. In reviewing proposed organic plans, certifying agents should determine where good faith efforts on the producer's behalf merit the use of a restricted practice.
This approach would also improve provisions in the Proposed Rules where the clause "if necessary" is used to modify the decision making process of a producer or handler. The clause is used to frame decisions regarding the use of livestock of non-organic origin, when livestock can be given non-organic feed or have restricted outside access, when highly soluble fertilizers are allowable and when incidental additives can be used in processing. There are no requirements in the Proposed Rules for producers, handlers and certifying agents to agree in advance on what constitutes necessity in these matters. If producers and handlers act unilaterally on the basis of necessity, their certification status becomes contingent on an after-the-fact review by the certifying agent. This procedure does not adequately protect producers and handlers or give certifying agents the right to approve or reject a practice in advance. It would be best if the determination of necessity be made in advance with consent of the certifying agent or, in case of an emergency, after deliberation between the parties.
Material annotations
The NOSB recommended to the Secretary very specific use requirements for many of the materials on the National List. For example, the NOSB recommended that newspaper mulch be placed on the list of allowable synthetic materials but that its use be restricted such that glossy paper and colored ink paper are prohibited.5 The NOSB referred to such specific use requirements as material "annotations," as do many existing state and private certification programs. In all cases, the annotations further restricted and narrowed the use of synthetic materials, a primary goal of the OFPA. To the dismay of the NOSB, the organic industry, and consumer and environmental groups, the Proposed Rules do not include the annotations recommended by the NOSB. All the materials on the National List are available for use at any time and in any way producers and handlers see fit, so long as their use does not result in "measurable degradation."
We concur with the NOSB in their finding that the concept of "measurable degradation" should be dropped from the Proposed Rules. While the concept is theoretically appealing, it is not workable. In applying the concept to soil, for example, it would be difficult for a certifying agent to measure and make a determination about degradation when soil often degrades in small incremental steps (i.e., compaction leads to loss of air which leads to loss of microbes, which leads to loss of earthworms, etc.)6 Tillage also degrades soil to some degree. Because degradation is not easily measurable, it is imperative that the Final Rules include the annotations recommended by the NOSB. Just as certain practices should be restricted within the order of preferences system, certain materials should also be restricted within the National List system.
Manuals versus formal rules
We understand that only so much detail can and should go into formal regulation. We imagine that there was considerable internal debate within the USDA and the Office of Management and Budget over how much detailed information should be included in the formal rulemaking process versus administrative manuals or handbooks. While we favor the inclusion of as much information as possible in the Final Rules, we do expect that some sort of manual or handbook will be needed for the National Organic Program.
The Secretary has not indicated in the Proposed Rules whether manuals or handbooks are contemplated. The appeal of manuals and handbooks is that they can be amended more easily than formal rules and are more likely to include the kind of detailed information that translates national objectives into site-specific requirements. The downside of manuals and handbooks is that they do not provide the same level of public notice and comment and may be considered merely guidance which people are not compelled to follow. Deciding what information to put in a rule versus a manual is never an easy decision for regulators, especially when a program is as novel and controversial as the National Organic Program.
Overall, we recommend that Final Rules contain adequate information so that the public has the opportunity to comment on all important aspects of the regulations. Indeed, the very success of the organic label is largely due to the transparency of standards so important for consumer trust. The question remains as to what constitutes adequate information. Many of our colleagues argue that every last detail should be published in rule form. The obvious lack of USDA expertise in organic agriculture, coupled with the distrust created by several provisions of the Proposed Rules, has generated a demand for extremely explicit and detailed rules at the national level. We would like to suggest an alternative for the Secretary's consideration which may provide the accountability and expertise organic advocates demand without saddling the National Organic Program with an unworkable amount of detail at the national level.
We recommend that the Secretary take advantage of the vast amount of expertise in existing certification organizations by engaging them in the production of the National Organic Program manual(s). This would make the Secretary's efforts more efficient, since much of the information we might expect to be in a manual has already been developed by numerous organizations. It would also embody the private-public partnership spirit of the OFPA and help build trust between the Department and the affected organic, consumer, and environmental communities. Finally, and most importantly, such a collaboration would benefit certification entities and the staff of the Department because joint production of manuals will lead to enhanced understanding of organic production opportunities and constraints.
We recommend that the Secretary formally engage the NOSB to develop the National Organic Program manual.7 The NOSB would, in turn, solicit input from existing state and private certification programs, the Organic Materials Review Institute and other appropriate entities. In this way, the Secretary would escape appointing a new advisory committee, (as we understand that resources are limited for such committees) but still have a forum to convene the appropriate experts under the auspices of the NOSB. More detailed manuals would be developed by individual certifying agents which would be submitted to the Secretary as a requirement for accreditation. While such a system is not contemplated in the Proposed Rules, it certainly has precedent at the Department. The Field Office Technical Guides developed under the National Resources Conservation Service may be a useful model for the National Organic Program. Formal rulemaking occurs for NRCS conservation programs but many of the details necessary for site-specific application are developed by individual state offices. 8 Each state office develops Field Office Technical Guides on various subjects that are reviewed periodically and updated when needed. Of course, this option may raise the concern of multiple "standards" being proposed in the form of manuals from state to state and certifying agent to certifying agent. However, we envision such manuals as simply implementation plans that would require the Secretary's approval. As such, we are unconcerned that such manuals will lead to a multiplicity of organic standards.
Organic Crop Production Requirements
Section 205.5 Land requirements
We support the provisions contained in Section 205.5 with one exception. Section 205.5(2) stipulates that certified crop land must have clearly defined and identifiable boundaries. If such land adjoins non-organically managed land, the Proposed Rules further stipulate that a producer shall protect his land from potential contamination from adjoining properties. Both the OFPA and the Supplementary Information identify buffer zones as one appropriate way to protect certified crop land from contamination. Additional methods noted are physical barriers and runoff diversion systems. While it would be unreasonable to specify boundary protection requirements at the national level, as needs will vary from site to site, such decisions should not be left solely to the producer. Certifying agents must be empowered to make the determination of what, if any, boundary protection requirements are necessary. To this end, we recommend that the Final Rules require producers and handlers to address specifically in their organic plan boundary issues and the preventative measures they will take to insure the physical integrity of their certified crops. We suggest that Section 205.5(b) be amended to read "...a producer shall implement and include in the organic plan a proposal..." instead of "...a producer shall implement, or include in the organic plan a proposal to implement..." Such an amendment will allow the certifying agent to evaluate the suitability of boundary protections in the context of overall approval of the organic plan.
Section 205.6 Crop rotation
The Supplementary Information describes crop rotations as the "cornerstone of successful organic crop production," a description we wholeheartedly endorse. 9 Crop rotations epitomize the low-input, on-farm approach to addressing production needs which characterize organic agriculture. Intelligently used, they help producers resolve problems with soil structure, fertility and pest and disease management which would otherwise require synthetic remedies purchased off the farm. The multiple benefits and minimal impact of using crop rotations make them an ideal soil building technique to redress the inevitable damage that working the soil entails and they should be a part of every organic annual cropping system.
The Final Rules must mandate that producers incorporate crop rotations into their operations, unless explicitly exempted from such practice by a certifying agent. In contrast, the Proposed Rules provide producers too much leeway to escape crop rotation requirements. Section 205.6 states that "A crop rotation or other means of ensuring soil fertility and effective pest management in any field or farm parcel shall be established." The Supplementary Information identifies several other soil fertility methods, such as inter-cropping, living borders and rotational grazing as allowable under Section 205.6. All of these soil fertility methods are appropriate, and often desirable in organic systems, and the rich text in the Supplementary Information well describes the contributions of such methods. We understand also that under certain cropping conditions (e.g., perennials) and with certain crops (e.g., mushrooms) it is necessary to forego crop rotations. Nevertheless, producers should not be allowed to unnecessarily bypass crop rotation requirements simply by engaging in other practices which might mimic their benefits. Even pasture and range land requires crop rotations to prevent compaction, leaching and other such problems. To ensure that crop rotations truly remain the cornerstone of organic production, the Final Rules must include crop rotations as a required component of the organic plan. In addition, any alternative practices which producers propose as appropriate substitutes must receive approval from the certifying agency prior to the commencement of production.10
Section 205.7 Soil fertility and crop nutrient management
Raw manure use
The Secretary requests comment (Question #8) concerning the minimum time which must pass before a crop raised for human consumption on land to which raw manure has been applied may be harvested. While the OFPA establishes this period as not less than 60 days, several recent outbreaks of food contamination linked to improper manure management demand a closer look at this standard. The emergence of especially virulent and persistent strains of food borne pathogens make it imperative that manure management standards thoroughly address human health concerns. Research indicates that potentially fatal E. coli 0157:H7 can survive for eight to nine weeks in cool environments and nearly as long in warm ones. 11 While the OFPA allows the certifying agent to establish a reasonable post application interval, new information requires that a tough national minimum period be established to provide the best level of protection. For food safety purposes, we recommend that for crops intended for human consumption, harvest not occur until at least 120 days following the application of raw manure. At this time, most private certifying agents have adopted the 120 day period as an industry standard and we support its use in the Final Rules. 12
We recognize that pathogen problems may emerge in the future which may necessitate a blanket prohibition on the application of raw manure on all crops intended for direct human consumption. In such an event, the Secretary should not hesitate to implement minimum composting requirements prior to manure application. To that end, we recommend that the NOSB and the National Organic Program staff review the newly published FDA voluntary guidelines on good agricultural and manufacturing practices designed to minimize the risks of pathogen contamination of produce. The guidelines stress clean water, field sanitation and worker hygiene as key components of a safe fresh fruit and vegetables system. 13
Proper composting
The Secretary requests comment (Question #9) on whether there are situations when composted manure would have essentially the same characteristics as raw manure. We believe this question invites a discussion of proper procedures for the maintenance of a compost pile containing manure and the eventual field application of the finished product. If a producer were negligent either while maintaining or applying composted manure, it could have undesirable consequences comparable to those associated with the application of raw waste. For this reason, we a see a compelling need for the Final Rules to contain a much clearer articulation of the risks and benefits attendant to using composted manure in organic systems. 14 We believe this discussion must begin with a review of the intended benefits of the composting process, such as efficient nutrient and organic matter cycling, suppression of weed seeds, plant diseases and pathogens and odor control. After clarifying the objectives, the Final Rules should evaluate the specific management components which will contribute to the success of the operation, including origin of feed stock, pile temperature, duration of the process and turning of materials. Organic materials added to the composting process should be limited to those permitted for crop production in the Final Rules, such as manure, plant residues and mulch. Compost should not contain synthetic materials beyond an incidental residue, municipal solid waste or sewage sludge. Compost must be managed to reach temperatures sufficient to effectively stabilize nutrients and kill pathogens. At a minimum, the process requires that organic matter reach temperatures of approximately 55 degrees C for a period of several days to achieve anaerobic decomposition. It must then be thoroughly mixed, achieve similar temperatures again and undergo a final six weeks of curing. 15
A thorough explanation of what the Secretary considers effective composting procedures along with a summary of undesirable outcomes, such as nutrient leaching or volatilization, foul odors and persistence of pathogens, is needed to encourage producers to make composting a high priority in their operations. Producers also require guidance on proper application techniques. Many private certification standards prohibit practices such as applying compost to frozen ground or sandy soils which could facilitate loss of nutrients.16 Provisions for how and when to incorporate compost once it is applied are also necessary.
Manuring materials
Some of the materials and practices for proper manuring contained in the Proposed Rules are clearly inadequate for organic certification and should not be treated as equal or analogous to those at the higher end of the order of preferences. The Proposed Rules must be amended to favor significantly stricter manuring standards and to create a clear threshold between approved, restricted and prohibited practices. The inclusion of Sections 205.7(b)(4) and (5) is unacceptable. Provisions in these sections deviate dramatically from currently approved manuring practices and allow for the introduction of a broad array of traditionally prohibited materials. The creation of the non-active residue category as a potentially permissible component in manuring operations invites the use of synthetic materials not approved for the National List as well as natural materials prohibited from use and known to have persistent environmental effects. The OFPA categorically prohibits these materials from being used in organic production regardless of their concentration. Creating the non-active residue exemption enables the USDA to propose cotton gin trash, confinement livestock manure and municipal solid waste as potentially acceptable sources for composted materials. Subsequent provisions which we also oppose would allow making chemically altered plant and animal waste materials such as leather meal, newspaper and kiln dust acceptable for use in organic systems.
In terms of process, we believe that it will be impossible for a producer, a certifying agent or the National Organic Program itself to consistently and accurately monitor the effects of the materials allowed under Sections 205.7(b)(4) and (5) once they are introduced into organic food production. There are no effective provisions to monitor the myriad of contamination sources potentially found in solid waste or other proposed nutrient sources. We see no benefit in allowing producers to use an array of potentially contaminated materials without first establishing that safer alternatives are unavailable. As written, the Proposed Rules represent an unacceptably low standard and provide no encouragement for producers to move towards more sustainable, farm derived solutions to their manuring needs. To redress these problems, we suggest prohibiting several categories of materials currently allowed in the Proposed Rules and placing a greater burden of proof on producers to support their management decisions. We recommend that Sections 205.7(b)(4) and (5) be deleted. This would limit the materials permissible for manuring under the order of preference to strictly segregated organic materials produced on the farm as well as in processing facilities. Secondly, we recommend that producers be required in their organic plan to explain where they stand in the order of preference and what measures they will undertake, if possible, to move their practices and materials higher on the scale. These recommendations will provide better safeguards for sourcing manuring and compost materials and enable certifying agents and producers to work together through the organic farm plan to instill spirit into the letter of the law.
Nutrient sources
The Secretary requests comment (Question #10) on the use of highly soluble or synthetic materials as crop nutrient sources in organically managed systems. We strongly support a more restrictive, pro-active approach which firmly distinguishes between organic and conventional production and encourages producers to continuously adapt their management practices for enhanced sustainability. Producers should be required to justify their practices based on a thorough evaluation of all available options and certifying agents must retain the authority to require modifications through revisions to the organic plan. Of the materials described in Sections 205.7(2)(i)-(iii), we recommend that non-synthetic minerals which are highly soluble be restricted for use in organic production. Fundamentally, these materials satisfy a crop's immediate nutrient requirements without contributing to the long term environmental conditions which support and improve soil quality. We prefer a policy similar to that which the NOSB drafted for the management of Chilean nitrate. These guidelines established a limit on the proportion of total nutrient demand which the highly soluble material could provide and required producers to develop plans for alternate sources in future years. This approach is not punitive or prohibitive, but instead recognizes that farmers and certifiers can collaborate and improve production systems over time.
We are concerned that provisions and terminology in Section 205.7 will obscure the fundamental distinction between natural and synthetic materials required to determine appropriate soil fertility and crop nutrient management practices. For example, Section 205.7(c)(1)(ii) allows substances "extracted from a plant or animal substance or from a mined mineral" for supplying mineral nutrients. While we do not question the suitability of plant, animal or mineral materials as sources for mineral nutrients, we strongly disagree with the statements in the Supplementary Information that "we do not consider the extraction method to be consequential when used to obtain substances form non-synthetic sources" and "The extraction method alone would not cause the substance to be synthetic..." We believe that the method of extraction is inseparable from the quality and character of the finished product and that natural materials which are synthetically processed must be individually reviewed for inclusion on the National List. The Proposed Rules provide far too much leniency for allowing industrially treated materials to become approved and that opening the door to an array of synthetic materials will undermine organic integrity. 17 We recommend that Section 205.7(c)(1)(iii) be amended to require chemically extracted mineral nutrients to be classified as synthetic materials subject to NOSB review for inclusion on the National List.
Section 205.8 Selection and use of seeds, seedlings and planting stock
We recommend that the Final Rules allow for the use of treated seed only if the synthetic materials used in the treatment appear on the National List, as provided in the OFPA. As explained in the Supplementary Information, the Secretary does not intend to require materials used in seed treatment to be included on the National List. We cannot support the Secretary's rationale that treated seeds do not constitute active ingredients because if the treatment served no function, there would be no reason to use it. While the OFPA specifically identifies treated seed as a category of synthetic material suitable for organic production, the law clearly establishes that each such material be reviewed and added to the National List prior to use. To excuse seed treatment materials from this review would contradict a fundamental provision of the OFPA and needlessly confuse the distinction between allowed and prohibited synthetics.
We recognize that in states where planting stock is required to be treated with pesticides, this prohibition may be a problem, but not one unanticipated by the OFPA. Ideally, such states will provide exemptions for organic growers and we urge the Secretary to work with the State Departments of Agriculture to enhance their understanding of organic production requirements. But if such exemptions are not forthcoming, the NOSB can calculate these requirements into their National List deliberations.
We recommend that the Final Rules incorporate the NOSB recommendation that, in those rare instances when unavoidable weather or natural disaster make it impossible to reasonably obtain organic transplants and planting stock, producers may qualify for an exemption to use transplants and planting stock treated with synthetic or prohibited materials. In such cases, it is critical that the certifying agent, not the producer, make the determination whether such an exemption is merited. While we believe that a genuine disaster could justify the use of non-organically produced transplants and planting stock in the absence of organic supplies, we oppose the provision in Section 205.8(a)(2) which would allow for this substitution solely on the basis of commercial availability. If a particular species or variety of a species cannot be produced and maintained under organic management, the National Organic Program need not bend the rules to allow it to be so labeled. We favor restricting exemptions to cases of natural disaster or genuine emergencies because they represent an unavoidable disruption of an otherwise functional organic operation which would have no alternative but closure. A blanket exemption predicated on commercial availability would allow the routine incorporation and perpetuation of non-organic practices and materials into a certified operation.
Finally, there are several missing items in Section 205.8. We had expected to find provisions for unique cropping environments, such as greenhouses, and for specialty crops, including mushrooms and sprouts. These are areas which already play a significant role in organic agriculture and should receive specific attention in the Final Rules. We suggest that the USDA adopt the NOSB's Final Recommendation Number 3 from April 25, 1995 on specialized standards for greenhouses, mushroom and hydroponic production.
Genetically engineered organisms
The suitability of genetically engineered organisms (GEOs) for organic production is the issue of greatest public interest within the complex debate over the Proposed Rules. 18 To preface our comments on this issue, we would like to stress that the Wallace Institute, like many sustainable agriculture organizations, is neither a proponent or opponent of genetic engineering and other agricultural biotechnology methods. While we are discouraged by most current applications of biotechnology in agriculture, we nevertheless anticipate that other, more promising applications will become available in the future. 19 In the meantime, we expect that all applications of agricultural biotechnology be scrutinized for potential risks to the environment and human health, evaluated against other available technologies, and assessed for potential benefits to the farming community.
In this section, we offer our views and recommendations on the suitability of GEOs under the National Organic Program — and only under the National Organic Program. If the Secretary desires comments regarding activities under other agencies such as the Animal Plant Health Inspection Service, the Foreign Agriculture Service or the Agricultural Research Service, the Wallace Institute stands ready to assist. We recognize that different programs and services of the Department have unique needs and that it is critical to distinguish between comments made and positions taken regarding biotechnology generally and those specific to organic production. In this vein, we urge the Secretary to disaggregate the needs within the Department's many agencies and programs and respond specifically to the needs of the National Organic Program.
The Secretary asks for public comment on GEOs in organic production. In so doing, the Secretary advises that "the policy of the United States Government is that GEOs and their products should be regulated based on risk, not on how they are produced." We understand that the Secretary is concerned that a prohibition on GEOs in organic production may present an internal policy contradiction. Before we turn to our specific recommendations on GEOs, it is necessary to remind the Secretary that almost eight years ago Congress declared that organic was and would continue to be a production claim (as opposed to a food product safety claim). 20 This too then is the policy of the United States Government and one that is underscored again and again in congressional committee reports and hearings, the Congressional Record, and in the statute itself. We implore the Secretary to construct policies that reflect the complexity of multiple United States Government objectives.
The Secretary requests comment (Question #11) as to whether GEOs should be permitted, prohibited, or allowed on a case-by-case basis in organic production systems. Our answer to this is to uphold the NOSB process for making this determination as provided for in the OFPA. To begin, the Secretary must make plain in the Final Rules that all GEOs, including transgenic crop plants, are synthetically produced as defined by the OFPA. 21 Given their novel production techniques and the definition of synthetic included in the Proposed Rules — "formulated or manufactured" — we see no leeway for classifying GEOs in any other way. Furthermore, it is essential to extend the consistent historical designation by both domestic and international organic certification agencies of GEOs as synthetic materials.
Once GEOs are clearly defined as synthetic, any GEO or transgenic crop allowed for in organic production must be approved by the NOSB, and subsequently the Secretary, for inclusion on the National List of allowable synthetics.22 Thus, it is the NOSB that makes a decision as to whether to allow GEOs on a case-by-case basis for inclusion on the National List. The Secretary may, before or after public comment, delete GEOs from the National List that the NOSB has recommended, but he cannot add GEOs that are not first recommended by the NOSB. During the last several years of NOSB deliberations and materials review, the NOSB proceeded to review all petitions for GEOs presented to the NOSB for placement on the National List.
Every material on the National List must be established as not harmful to human health or the environment, necessary because of the unavailability of wholly natural substitute products and consistent with organic farming and handling.23 We concur with the NOSB determination that at this time no proposed GEO satisfies these criteria. 24 While the potential to do harm and the availability of natural alternatives are vital considerations, we believe that the consistency with organic practices criterion will prove by far the hardest for GEOs to satisfy. Too much of what we see with the commercial application of GEOs involves bypassing, overwhelming or simply ignoring the natural system of checks and balances which organic producers acknowledge and work within. For example, we do not see the consistency with organic principles of an herbicide tolerant GEO which facilitates greater pesticide applications or a plant which expresses Bt in its foliage and hastens resistance in pest populations.25 Essentially, commercial genetic engineering applications have isolated and exaggerated specific characteristics or properties to endow species with new or enhanced capabilities. Such a single species, single trait approach is fundamentally inconsistent with organic systems which promote biodiversity, biological activity and ecological harmony by using production practices appropriate to local conditions.
The technical and scientific considerations which the Secretary requests provide ample arguments against using current applications of GEOs in organic production. An analysis of current commercial applications of GEOs confirms that transference of genes to wild relatives, accelerated emergence of resistance in pest populations, unforseen impacts on non-target species and adverse reactions in bioengineered species are problems.26 The uncertain performance of GEOs in commercial scale production, as well as the unforseen environmental impacts they will engender, are incompatible with the organic principle of working in harmony with nature. The evidence to date indicates that the field performance of GEOs will resemble a roller coaster ride which may suit high stake, high risk commercial agriculture but is certainly foreign to the cautious, balanced and fundamentally conservative character of organic production.
It is because of these technical and scientific considerations that GEOs have traditionally been considered incompatible with organic practices. Indeed, almost every organic standard program, whether private, state or foreign, prohibits GEOs. It is important for the Secretary to fully understand that if GEOs are allowed in organic production at this time, it will likely lead to domestic and global trade upheaval and create serious equivalency problems for U.S. producers. The Codex Alimentarious, the international food safety and hygiene standard setting agency for the Food and Agriculture Organization and the World Health Organization, prohibits their use.27 The European Union, which has a healthy and growing demand for organic produce, would be unlikely to grant equivalency to American commodities produced under standards which allowed GEOs.28 Existing international commerce in organic goods involves commodities free of GEOs and there is no indication that these conditions will change in the future. The Secretary will cripple American farmers capacity to engage in, what has been up to now, highly profitable international trade in GEO-free organic products.
Domestic market disruption must be considered by the Secretary as well. The extremely vocal and overwhelmingly negative public response to the possibility of incorporating GEOs in the national organic standards is a factor too large to be ignored. Quite simply, if virtually everyone of the many thousands of people who venture an opinion about the Proposed Rules feels that GEOs should be prohibited, Final Rules which circumvents the NOSB decision making process and allows them would be unconscionable.29 The millions of Americans who purchase organic food have a nearly universal understanding that such food is not produced using GEOs. Introducing such materials at this time would dilute the burgeoning public interest in organic production and risk pulling the rug out from under the market. We do not intend to use the NOP as a forum to discredit or disparage the role of GEOs in modern agriculture. However, we do believe that consumers want and deserve the option of selecting foods raised and processed without the use of biotechnology and that certified organic does and should continue to meet this need for millions of Americans.
Genetic engineering may someday provide valuable services to the organic industry. We recommend that the Final Rules classify all GEOs as synthetic and request that individual petitions for GEO product use be submitted to the NOSB. The NOSB is taking the initiative to develop procedures for reviewing GEOs using criteria which are consistent with the OFPA and sensitive to the concerns and expectations of consumers. We support the NOSB's 1996 decision to hold off on approving petitions involving GEOs and to re-visit the issue at a future date when the technology achieves a better fit with organic principles and consumer expectations. The NOSB well represents the organic industry and consumer and environmental groups. If the time ever comes when the NOSB approves certain GEOs for organic production, we expect it will occur because new information has emerged that causes affected consumers, environmentalists, and organic farmers and handlers to invite GEOs into organic production.
Section 205.9 Prevention and control of crop pests, weeds, and disease
We take exception with the provision contained in Section 205.9(e)(1) which allows any non-synthetic biological or botanical substance to be applied to prevent, suppress or control pests, weeds or diseases. We feel that this is too lenient an approach towards broad categories of materials and we prefer the case-by-case review system used by the NOSB. There are production and environmental considerations which must be evaluated before botanical or biological agents can be approved for use in organic systems. The NOSB determined that strychnine and tobacco dust (nicotine) should be placed on the National List of Prohibited Natural Substances yet these materials are allowed under the Proposed Rules. We recommend that language in Section 205.9(e)(1) be amended to read "any non-synthetic biological or botanical substance not found on the National List of Prohibited Natural Substances..." We also encourage the USDA to incorporate the NOSB's October 14, 1994 guidelines for using botanical pesticides into the Final Rules.
We object to the provision in Section 205.9(e)(2) which creates a place on the National List for synthetic salts used to defoliate cotton. There is no provision within the OFPA to recognize this category as an allowable synthetic. In addition, the use of these materials is not representative of the established practices of organic cotton growers. No existing state or private certification allows the use of synthetic salts as defoliants and no producer was found to be using them in a field survey conducted by the Organic Fiber Council in California, Texas and Missouri.30 Synthetic materials are prohibited as defoliants under the standards of the Texas Department of Agriculture which has the most comprehensive organic cotton certification program in the country.
Section 205.10 (Reserved—irrigation water)
We believe that Final Rules should require producers to address source and quality issues related to the use of irrigation water in their organic plan.31 We recommend that water used for irrigation of organic crops not contain any prohibited materials intentionally added by the producer. Water that contains prohibited materials resulting from unavoidable residual contamination may be used. The certifying agent may require analysis of crops grown with irrigation water for contaminants and should be empowered to deny certification to products whose contaminant levels exceed the tolerances set in Section 205.431.
Section 205.11 Wild crop harvesting
We support provisions in Section 205.11(b) which require that a wild crop "shall be harvested in a manner that assures that such harvesting or gathering will not be destructive to the environment and will sustain the growth and production of the wild crop." We also support subsequent provisions in Section 205.205(d)(4) which outline specific detailed information on population dynamics and environmental impacts which individuals engaged in wild cropping must incorporate into their organic plans for the materials they wish to collect. We commend the Department for recognizing the potential for commercial exploitation to jeopardize wild populations. Increased demand for many popular wild cropped herbs including American ginsing, echinacea and goldenseal have significantly depleted and in many cases eliminated populations in many areas.32 Individuals who harvest organically grown wild crops bear the responsibility to substantiate that their activities are compatible with the long term viability of the target species within the collection area. We support the requirement that appropriate provisions and assurances to this end are included in an organic plan subject to approval by an independent certification agency. We recommend that the NOSB be tasked with developing more thorough standards for wild harvesting with particular emphasis on game animals and aquatic species.
Organic Livestock Production Requirements
General comments
One of the greatest challenges for the Secretary, the NOSB, and organic agriculture advocates is developing rules for organic livestock production. To date, the Department has outlawed the labeling of meat, poultry and egg products as organic, leaving consumers to pick and choose among permissible label statements such as "natural" and "free range." This USDA prohibition has stifled innovation and as a result no state and few domestic private organizations have developed livestock standards from which to model a national program. This USDA prohibition has also stifled demand in the marketplace at a time when consumer interest is escalating. For example, dairies, which are not prohibited from making an organic claim on the fluid milk and related products they produce, provide a glimmer of the potential demand for organic meat, poultry and egg products. Organic dairies more than doubled production capacity between 1992 and 1994; we expect that strong national livestock standards will bring about similar expansion and profit in the meat, poultry and egg markets. 33
Organic livestock production standards constitute a milestone for the American organic industry, but they should not be developed in isolation from existing international market considerations. International organic livestock standards do exist and we recommend that U.S. standards be developed that fit within the guidelines of the International Federation of Organic Agriculture Movements (IFOAM) adhered to by many countries.34 Because the IFOAM standards are the foundation for much international trade, the NOSB began its livestock deliberations using the IFOAM standards as a baseline. These international standards, combined with the public comment presented at the four public USDA livestock listening sessions and the numerous NOSB meetings during the period 1992-1997, provided a wealth of information for the NOSB and aided the Board in developing comprehensive livestock recommendations for the Secretary. International standards on issues including synthetic medications, animal confinement and origin of feed far exceed what is allowable under the Proposed Rules.
Beyond educating consumers and expanding markets, organic livestock production standards will provide tangible benefits, including price premiums and reduced environmental impacts, to the very producers who choose to adopt them. At its heart, organic agriculture represents an integrated and interrelated group of management practices which run contrary to the concentration and specialization which characterize so much of contemporary agriculture. By carefully balancing the needs of animals with the resources they provide, organic livestock management contributes towards developing a diversified and profitable farm. Sir Albert Howard, a pioneer in the philosophy and practice of organic agriculture, captured this sentiment in his observation that "Mother Earth never attempts to farm without livestock." 35 Animals do provide organic farmers alternative marketing opportunities but they can also contribute significantly to less capital and energy intensive management practices. Any farmer who has stacked manure will appreciate an animal that manages its own waste, at least part of the time, in a rotational grazing or free range environment. The establishment of meaningful and workable standards for organic livestock production will reward farmers for reintroducing animals into their management systems in ways which support environmental and economic sustainability.
Interim labeling
In 1989, Senator Leahy asked the USDA Food Safety Inspection Service (FSIS) to remove its prohibition on the organic labeling of meat and poultry products. The agency's refusal was one of the driving forces behind the 1990 OFPA. After almost a decade there is no change in FSIS policy; many producers are anxious to enter this market and Final rules are not expected soon. We believe these producers have suffered undue economic harm at the hands of the FSIS. We join the NOSB in supporting the Organic Trade Association petition to the Secretary which urges the FSIS to allow immediately the organic labeling of meat, poultry and processed egg products that are certified by a state or private certification agent.
Section 205.12 Origin of livestock
The Proposed Rules represent a considerable dilution of the OFPA statute and the NOSB recommendation regarding acceptable sources of organic livestock. One fundamental divergence is the addition to the Proposed Rules of a separate standard for the origin of livestock intended for slaughter. Neither the original legislation nor the NOSB recommendations create separate conditions for sourcing livestock based on the intended end market. Instead, they use a consistent standard based on pre-natal care during the last one third of gestation to determine eligibility for certification. Table 1 identifies distinctions in the provisions for livestock origin between the OFPA, the NOSB recommendations and the Proposed Rules.
| Table 1. Suitable origin for livestock designated as organically produced | ||
|---|---|---|
| OFPA LANGUAGE | NOSB RECOMMENDATION | PROPOSED RULE LANGUAGE |
| Does not distinguish slaughter from breeder stock. Breeder stock may be purchased from non-organic source if such stock is not in the last third of gestation. | Only slaughter stock that are progeny of female breeder stock under organic production methods from the last third of gestation or longer shall be considered organic. | If necessary, no later than the 15th day of life for mammalian livestock of non-organic origin to be designated as organic slaughter stock for production of meat. This exemption is extended to any stage of life for bees and no later than the earliest commercially available stage of life for other livestock types. |
The Secretary requests comment (Question #12) on the conditions under which non-organic mammalian livestock may be used as organic slaughter stock. We do not support making non-organic mammalian livestock an allowable source for organic slaughter stock. The Proposed Rules reflect the OFPA provision and the NOSB recommendation that breeder stock must be managed organically during at least the last one third of gestation for its offspring to become certified. However, the exemption which allows mammalian slaughter stock of non-organic origin to be brought into certified production up until the 15th day of life will weaken the organic industry's incentive and ability to supply its own needs. Provisions which allow for sourcing of essential items from non-organic supplies create a disincentive for farmers to invest the additional time and expense required to either produce or purchase the organic alternative. An exemption which allows mammalian livestock of non-organic origin to become certified as slaughter stock will entrench dependence on the conventional production systems which organic consumers and producers seek to avoid. The purpose of organic certification is to provide a genuine, verifiable and comprehensible distinction between management systems. The current Proposed Rules dilute these distinctions by making non-organically managed young livestock an acceptable source for organic production. Such a provision would make many production practices which the Proposed Rules explicitly prohibit in adults allowable in the very same animals during their first 15 days of life. Such a standard would confuse consumers, obscure rather than delineate the distinctions between organic and non-organic management and impede the maturation of markets for organically produced mammalian stock.
We support provision 205.12(a)(2) of the Proposed Rules which requires that livestock reside at least one year under organic management prior to allowing milk or milk products to be labeled organic. We are concerned, however, that this may favor the procurement of purchased stock from non-organic sources in lieu of farm-raised replacements. The proprietor of an organic dairy could reduce operating costs by consistently procuring new stock from non-organic sources and maintain them for one year rather than raising newborns under continuous organic care. With dairy cows, for example, a proprietor could avoid the full first year of organic care by opting to purchase and convert year-old stock. Animal husbandry practices may require bringing new stock onto the farm but the National Organic Program should establish preferences for organically raised substitutes. We look to the NOSB to find ways to encourage and reward dairy producers for raising replacement stock from their own and other existing organic herds. Such a revision would support self-sufficiency and problem solving at the farm level.
We take exception with the reasoning and intent of Section 205.12(a)(4) which establishes the required residency period under organic management at no less than ninety days for livestock used in the production of non-edible livestock products. The Supplementary Information sheds no insight on why the USDA feels this shortened interval is sufficient time for certification. Ninety days is certainly an inadequate amount of time to insure, as the USDA suggests, that the breeder animals covered by this provision will be included in the overall farm management system. Weakening standards predicated on an animal's ultimate market use will erode the public's understanding and support for organic production as a holistic and consistent production system.
Honey bees
We support the effort to address provisions for organic bee management beginning in Section 205.12(5)(i) but find the Proposed Rules fragmentary and unworkable. In fairness to the Secretary, previous attempts to draft organic bee management standards have proven uniquely challenging. Standards which comply with organic principles are extremely difficult for commercial beekeepers to satisfy. Both conventional and organic producers face multiple crises in domestic honey bee management. Addressing these crises is of tremendous importance not simply for the honey and by-products from the hive but also because of the integral role bees play as pollinators. Given the importance of the issue to the entire agricultural community and the dearth of good existing standards, we believe that the subject of organic bee management should be returned to the NOSB for further consideration.
There are two unmet challenges in organic bee management: assuring access to non-contaminated forage supplies and the prevention or treatment of diseases affecting the hive. The stipulation in Section 205.13(a)(1)(iv) that bees from which organic products are derived shall forage primarily from organic acreage is unenforceable. Using a conservative estimate, bees forage two miles from the hive, meaning a producer would be responsible for monitoring more than 8,000 acres for organic suitability. Most private standards require a two to three mile radius of certifiable foraging area and many establish mandatory setbacks from specific contamination sources including landfills, golf courses and areas of congested traffic. Even these restrictions cannot prevent contamination that comes from drift or other bee colonies. Only under extremely rare conditions are beekeepers able to comply with the stringent foraging area and setback provisions needed to minimize if not absolutely eliminate chemical adulteration of bee products.
Treatment options for varroa and tracheal mites are limited and these pests have devastated commercial and wild bee populations nationally. Treatment of mites is an uphill battle even under conventional management practices which utilize antibiotics that are impermissible in organic systems. Current research indicates that organic treatment options using essential oils may keep damage from mites to a minimum but the risks of infestation and catastrophic losses will prevent rapid adoption of these techniques. The risk of transmission causes many beekeepers to describe preventative mite treatment using antibiotics as a responsibility comparable to vaccinations in livestock. Bees are well known for robbing from their weaker neighbors and often contaminate their own hives with mites they pick up while raiding untreated hives. The severe decline in wild bee colonies and the chronic infestation even in well managed commercial hives are evidence that provisions for mite treatment must be addressed in the Final Rules.
The twin challenges of suitable foraging area and mite treatment are not currently resolvable using practices which conform with organic principles. Rather than dilute the standards for the sake of allowing more producers to gain certified status, we recommend that the Secretary publish Final Rules which contain strict restrictions on both forage area and mite treatment. There may be a time when further research will allow the adoption of different standards. For example, certain techniques for administering antibiotics as a preventative treatment for mites have been shown to leave no detectable residues in honey and pollen extracted from the hive. There may be better ways to manage or control forage areas which would be mutually satisfactory to beekeepers, certifying agents and organic consumers. If strict standards for bee management results in limited commercial availability of organic honey and pollen, we strongly encourage consumers to do their own research and identify local producers whose production practices they can support. A product need not have an organic seal for consumers to decide that purchasing it makes good environmental sense.
Section 205.13 Livestock feed
The Secretary requests comment (Question #13) on the conditions under which non-organic feed may be used. The Supplementary Information identifies organically produced feed as "one of the foundations of organic livestock management," yet the Proposed Rules allow 20% (or more in an emergency) of the annual feed ration to be non-organic. This is one of the most glaring weaknesses in the Rules. The 20% exemption will weaken the market for certified grain and pasture and undermine public appreciation for the benefits of 100% organic feed. Domestic supplies of organic grain and pasture land have not lagged behind demand and a 100% organic feed requirement would tap the tremendous potential for expanded production. 36 Consumer preference for organic products is based, in part, on food safety concerns and the routine incorporation of non-organic feed dilutes the notion that organic constitutes a genuine alternative. Extensive research has documented that chemical residues will bioaccumulate in the fat tissues of meat products and that herbicides used on feed grains are a significant source for this type of contamination.37
In recognition of the unpredictability of agriculture under any system of production, the provision for an emergency feed exemption contained in Section 205.13(a) is warranted. However, we believe that the certifying agent and not the USDA Administrator is best able to evaluate the site specific conditions which constitute an emergency and should retain the discretion to make the declaration. We also favor adoption of the NOSB recommendation which clarifies the conditions under which an emergency may be declared and implements practical procedures to best protect the integrity of organic livestock production:
In the event of a feed availability emergency, non-organic feed may be fed to certified organically produced livestock on an extremely limited basis, provided that the certifying agent is immediately notified of the emergency and establishes a maximum time period during which the non-organic feed may be used. Efforts to locate feed which has been produced without the use of prohibited substances shall be documented. Feed availability emergency is a temporary and unforeseeable shortage of certified organic livestock feed due to emergency conditions beyond the producer's control. This emergency must be verified by the certification agent using consistent criteria to ensure uniform exceptions. In the case of such emergency, the producer shall make every reasonable effort and maintain a record of every such effort to locate organically grown feed, using the following prioritization:
- Certified Organic Feed
- Non-certified Organic Feed
- Feed from farms under organic management for 2 years
- Feed from farms under organic management for 1 year
- Conventional Feed38
We are concerned that a one year comprehensive organic care requirement, while an important and valid approach, will create an incentive to purchase replacement dairy stock over farm raised newborns. Economic considerations will likely push producers to minimize their costs by reducing the residency period under organic care to the shortest required option. To reward producers for raising their own replacement dairy stock, we propose that such farm born animals be allowed to receive non-organic feed up until one year prior to the beginning of certified production. All additional organic requirements for health care, living conditions and manure management would apply during the first year but the exemption from the feed requirement would reduce a significant out of pocket cost to producers while providing a level of care consistent with that of replacement dairy stock.
We strongly support incorporation of language in Section 205.13(3)(b) to prohibit the feeding of mammalian and poultry by-products to organically certified livestock. The potential link between animal residues in livestock feed and the transmission of bovine spongiform encephalopathy has already led to significant modification of Food and Drug Administration guidelines for livestock feed.39 The Final Rules adopted by the FDA in June, 1997, however, do not provide a comprehensive prohibition on using rendered animals in livestock feed. We believe that mammalian and poultry by-products are in no way necessary to organic production and that an explicit prohibition on their use is mandated.
Section 205.14 Livestock health care
The Secretary requests comment (Question #14) on the use of animal drugs in the production of organic livestock, including organic slaughter stock. We recommend that Final Rules adopt the NOSB recommendation to prohibit the administration of antibiotics to slaughter stock and prohibit antibiotics for breeder stock during the last third of gestation. The development of alternative health care practices for livestock production represents a remarkable achievement for the American organic and sustainable agriculture movement. By discovering new techniques and reintroducing some forgotten ones, alternative health care practitioners have avoided dependence on medicines and procedures which the rest of the industry deems essential. Much of this success is attributable to a preventative approach which respects the needs as well as limitations of the animals being treated. Equally impressive successes with homeopathic and probiotic treatments have been developed when disease does occur. The documented ability of dairy producers and ranchers to develop and implement viable alternative health care practices is a core distinction between organic and non-organic production systems. The Proposed Rules for livestock health care are inadequate in distinguishing these differences; we favor greater clarity and stronger restrictions in the Final Rules. A stricter standard would acknowledge and reward the tremendous progress which producers have made in developing alternative health care practices and foster continued market growth for products which consumers eagerly want.
| Table 2. Comparison of NOSB recommendations and Proposed Rules language for animal drug procedures for selected livestock categories. | ||
|---|---|---|
| ANIMAL TYPE OR PRODUCT | NOSB RECOMMENDATION | PROPOSED RULES LANGUAGE |
| Breeding stock | Offspring may be certified organic if antibiotic application does not occur during last third of gestation. Future progeny may be organic. | No restrictions on the use of allowed animal drugs during pregnancy. |
| Slaughter stock | The use or application of antibiotics is prohibited. Animals which receive emergency treatment must be diverted to the conventional market. | May receive animal drugs during the first 21 days of life and during the first 7 days after arrival onto a certified facility. |
We take exception to Section 205.14(b) which establishes guidelines for livestock health care treatment beyond the scope of preventative management. We disagree with the USDA's introduction of the term "animal drug" as an encompassing reference for all medication, antibiotics and parasiticides. Both the OFPA and the NOSB recommendations went to great lengths to distinguish among healthcare treatments and it is important to maintain these distinctions. Guidelines should be developed for each category of materials; they should not be considered as a single class. The inclusiveness of the term "animal drug" is compounded by subsequent provisions which allow drug usage for extended periods before and after livestock are brought into a certified facility. These provisions also sanction the use of topically administered animal drugs and parasiticides at any time of an animal's life. The end result of the Proposed Rules is to weaken dramatically the legislative intent of the OFPA and the recommendations of the NOSB and to ignore the field proven successes of contemporary organic livestock health care practices.
Guidelines for the use of animal drugs in the Proposed Rules appear more responsive to parameters drawn by the FDA for non-organic production than do the more restrictive guidelines recommended by the organic industry. The Supplementary Information states that extending withdrawal periods beyond FDA mandated periods "does not further the goals of a system of organic farming and handling." This statement contradicts well documented industry and consumer support for standards which either explicitly prohibit veterinary medicines or require extended withdrawal periods to minimize the risk of residue contamination. 40 We also question the USDA's assertion that most of the public concern about antibiotic use in animals is related to subtherapeutic doses which are prohibited. We believe that the actual presence of antibiotic residues and their potential implications for disease resistance are of great concern to the public regardless of the way in which the drugs are administered.41 Neither the substance of the Proposed Rules nor the rationale behind them adequately define or protect the definition of organic which current practitioners employ and the public trusts.
We recommend the NOSB recommendation on parasiticide use which provides that poultry from which eggs or egg products are labeled organic must have a 90 day withdrawal period. Furthermore, we recommend eliminating the exemption for drugs which are administered topically from review.
Section 205.15 Livestock living conditions and manure management
The Secretary requests comment (Question #15) on the conditions under which animals may be maintained so as to restrict the available space for movement or access to outdoors. The provisions outlined in Sections 205.15(a)(1)-(5) are insufficient to promote and insure livestock health. We advocate a more thorough and comprehensive description of the exact conditions suitable for animal welfare and support the NOSB requirements:
We strongly oppose Section 205.15(b) which allows, if necessary, for livestock to be maintained under conditions that restrict the available space for movement to the outside provided that other living conditions are adequate. This language coupled with the very weak description of what constitutes adequate living conditions could be interpreted to allow high density, confinement livestock operations to qualify for organic certification. We encourage the USDA to develop Final Rules with an explicit commitment to space and mobility requirements which respect animal welfare and environmental considerations. Restrictions on the space available for movement or access to the outdoors should not be permissible under routine or normal operation of a certified organic facility. Temporary confinement may be justifiable with the approval of the certifying agent for reasons of inclement weather, the immediate well being of an animal or animals (quarantine, for example) or the protection of soil and water quality.
Proper manure management is essential to achieve the full economic and environmental potential of an organic farm. Manure is a key source of nutrients for crop and pasture growth, and, if integrated properly, builds organic matter content which confers other soil quality benefits. However, if misapplied and poorly integrated, it may not only waste those valuable nutrients but cause environmental damage via soil, water and air pollution. A recent spate of water quality problems have been linked to excessive application of livestock manures in many areas of the country. The proposed rule on manure management which emphasizes the avoidance of water pollution, including human pathogens, and applications to optimize nutrient recycling establishes the basic principles to avoid those problems. We concur with the Secretary that burning cannot be considered proper manuring.
Organic Handling Requirements
General comments
Certification of handling operations is a relatively new enterprise. As noted in the Supplementary Information, only 600 handling operations are certified in the U.S. and only half of the existing state and private certifying agents have standards or certify handling operations. The OFPA, the NOSB recommendations, and the Proposed Rules have aided in the development of organic handling standards but none reflect the same level of comprehensive expertise evident in crop production requirements. We recognize that this will take time and experimentation and we look to the NOSB to lead a national dialogue to enhance our knowledge of what is possible and desirable in organic handling operations. In the meantime, we urge the Secretary to forego sweeping and unilateral standard decisions. Such decisions will naturally evolve through NOSB deliberations.
Material use in handling is an area of immediate concern, however. While the OFPA prohibits the addition of "any synthetic ingredient during the processing or any post harvest handling of the product," clearly the Congress anticipated that certain synthetic materials would be necessary and appropriate for organic handling. The Conference Report accompanying the OFPA states: "The Managers note that in the future it may be necessary to further develop a list of categories for processed food exemptions and therefore encourage the Secretary, working with the National Organic Standards Board, to recommend such a list to the Congress as soon as practicable..."43 Such a list has been recommended by the NOSB and submitted to the Secretary for inclusion on the National List. It remains to be seen whether it will be necessary to submit the list to the Congress for approval. In any case, the Congress established a clear process for material evaluation that mandates NOSB approval of all synthetic materials used in organic production. In this Section, we are once again alarmed to see the Secretary circumvent the law and propose the use of synthetic handling materials not approved by the NOSB and which, furthermore, fail to meet criteria set forth in the OFPA for material use in organic production. Final Rules should, at the very least, adhere to NOSB materials decisions which were arrived at after great deliberation and extensive public input. 44
Section 205.16 Product composition
The product composition requirements provided for in the OFPA and reflected here in the Proposed Rules are among the greatest advances of the National Organic Program over the current system. Currently, no state or private certification program includes product composition requirements; this Section of the Proposed Rules has the potential to revolutionize the marketplace. Until such time that Final Rules are implemented, consumers are often unable to ascertain how much of the total product is actually organic in origin. For example, if a consumer goes to the grocery store and buys organic cereal, s/he does not have any indication as to how much organic content is inside the box. We imagine that many consumers expect cereal labeled as organic to include 100% organic ingredients or thereabouts. The reality may be that the cereal contains as little as one percent organic content. The Proposed Rules for product composition represent a clear, high and comprehensible standard that will strengthen consumer confidence in the value and integrity of certified products and provide greater market opportunities for organic farmers.
In accordance with the OFPA, the Proposed Rules establish three distinct product composition categories. For the most part, these provisions are consistent with OFPA requirements and NOSB recommendations. The first category includes foods on which the term organic appears on the primary display panel as a descriptor of the entire product. To use the organic term in this way, the Proposed Rules would require a product to contain at least 95% organic content, excluding water and salt. The remaining five or less percent could include non-agricultural substances such as baking soda which appear on the National List under Section 205.26 as well as non-organically produced products.45 This five percent non-organically produced allowance was established by Congress to provide needed flexibility while establishing a very high threshold for use of the term organic. Determining what non-organic materials are allowable is an extremely challenging task due to the thousands of materials currently used in food processing. Consistent with congressional intent and NOSB recommendations, an orders of preference system is proposed to aid handlers and certifying agents in their determinations of what may be included in the five percent non-organic portion of a product. We support the Proposed Rules for this category.
The second category includes foods on which the term organic appears on the primary display panel, but only designates certain products as organic rather than designating the entire product as organically produced. Such products must contain at least 50% organic ingredients and the remaining 50% can include non-agricultural substances which appear on the National List under Section 205.26 as well as any non-organically produced products. No orders of preference system applies to such products. We support the Proposed Rules for this category. We do, however, recommend that once this category is established in the marketplace, data be collected to ascertain whether the requirements for this category are sufficiently rigorous. Without an orders of preference system, it is possible that handlers will forego increasing the organic content of their products, thereby limiting the availability of high content organic products that consumers demand.
The third and final category includes foods on which the term organic appears on the ingredient panel only. Such products contain less than 50% organic content and except for prohibiting contamination of the organic products, there are no other content requirements placed on these products, nor is an order of preference system proposed. Handlers of products that only use the term organic on the ingredient display panel are exempted from certification requirements; the Proposed Rules only require that such handlers maintain records to demonstrate upon inquiry that products represented as organic are from organic farms.
Section 205.16(a)(2)(iii) would permit use of agricultural products or non-agricultural ingredients extracted with a synthetic solvent, or which contain propylene glycol as a carrier, if mechanically processed alternatives are not commercially available. Solvent extraction for edible oils has been an unacceptable practice in the organic industry for nearly a decade.46 The NOSB evaluated methods of oil extraction for use in processed foods and determined that synthetic volatile solvents should be prohibited in organic production.47 Prior to taking this position, the NOSB recognized that the process of extraction from a natural source does not, in itself, make a material synthetic if its chemical structure has not been altered. 48 While concurring with this evaluation, we believe that the use of a synthetic material in the extraction process or as a carrier should automatically confer synthetic status on the resulting end product. As such, the end product would require NOSB review and inclusion on the National List before its use would be permitted. With this in mind, it would be inappropriate for the NOP to include synthetically produced materials within an accepted order of preference prior to NOSB review. We recommend that the Secretary delete the use of non-organically produced non-agricultural or agricultural product extracted with a synthetic volatile solvent or which contains propylene glycol as a carrier from the order of preference in Section 205.16(a)(2)(iii). In addition, we believe that any end product from a processing process involving a synthetic component must itself be classified as synthetic.
We support the prohibition contained in Section 205.16(e)(1) on the addition of sulfites, nitrates or nitrites to organic food products.49 In addition to being a statutory requirement of the OFPA and consistent with accepted certification guidelines, the prohibitions provide a valuable measure of protection to consumers with allergic or dietary problems related to these substances. The FDA estimates that one person in a hundred is sulfite sensitive and that five percent of those who have asthma are also at risk of suffering adverse reactions to sulfites.50
Section 205.17 Processing practices
The Secretary requests comment on conditions under which incidental additives may be used (Question #16).51 We support the NOSB recommendation that incidental additives, excluding volatile synthetic solvents and ionizing radiation, be allowed in organic processing 52 The Proposed Rules would allow all incidental additives, excluding volatile synthetic solvents, in organic processing. On first glance, the Proposed Rules may seem consistent with the NOSB recommendation, except for the issue of ionizing radiation. However, there is a critical procedural difference that merits attention. Many incidental additives are synthetic and therefore must be approved by the NOSB for inclusion on the National List. The Secretary does not explicitly recognize the need for NOSB approval of synthetic incidental additives nor the need to place this class of processing aids on the National List under Section 205.26. The Supplementary Information states that the NOSB created special procedures to allow processors to use incidental additives and therefore nothing in the Proposed Rules is inconsistent with the NOSB recommendations. However, the NOSB never ceded its material review responsibility to the Secretary or suggested that any synthetic materials are exempt from the National List procedures. Perhaps the confusion is created because the end result is the same: the NOSB deliberated on incidental additives and decided to add them as a broad class of processing aids to the National List.53 In order to comply with the OFPA and to ensure consistent treatment of all synthetic materials, Final Rules must acknowledge the need for National List review and add, under Section 205.26, the following: "incidental additives, except for volatile synthetic solvents and ionizing radiation." Finally, we must point out that the distinction advanced in the Proposed Rules between active and inactive incidental additives is not recognized by the FDA, not supported by science, and not an acceptable excuse to exempt processing aids from the National List process.
Our understanding of the conditions and prerequisites for use of incidental additives is nascent; certainly we prefer biological methods. We support the proposed orders of preference as applied to incidental additives and these preferences are consistent with the NOSB recommendation issued at the October, 1995 NOSB Austin, Texas meeting. However, we recommend against more detailed standards or preferences at this time. We fully expect that detailed standards for incidental additives in organic handling will evolve, under the guidance of the NOSB, over the next several years. We urge the Secretary to provide the necessary support to the NOSB to guide a national dialogue on this topic. Furthermore, we support the NOSB recommendation that would require handlers to list all incidental processing aids in the Organic Handling Plan as this will help certifying agents better determine compliance with the orders of preference. Finally, the same procedures and restrictions regarding incidental additives should apply whether the end product is labeled as "organic" or "made with certain organic ingredients."
We support the Proposed Rules that prohibit certain packaging and storage, including the use of certain waxes, on organic products.
Ionizing radiation (irradiation)
The Secretary requests comment in this section on the compatibility of ionizing radiation (a.k.a., irradiation) with a system of organic farming and handling (Question #17). It is important to note that the Secretary has not asked whether irradiation should be used at all, but has narrowed his question to the role irradiation may play in organic agriculture. Accordingly, our comments solely address the compatibility of ionizing radiation for organic agriculture. Our analysis leads us to conclude that, for six reasons, irradiation should be prohibited in the Final Rules.54
We recognize that the USDA and the Food and Drug Administration have invested considerable effort in evaluating the efficacy and safety of irradiation and our comments should not be construed as a challenge to the conclusions our government agencies have reached. 55 Irradiation of food does, without a doubt, aid in the control of insects, parasites and pathogenic bacteria such as the E-coli O157:H7, salmonella and campylobacter species. The FDA has approved irradiation for various uses on poultry, pork, fruits, vegetables, grains, spices, seasoning and dry enzymes, and just prior to publication of the Proposed Rules, for fresh and frozen red meats. We are also aware that irradiation has been endorsed by the United Nations World Health Organization, the American Medical Association and the American Public Health Association. We also recognize that many irradiated foods are labeled with a green symbol called a radura so that consumers know when they purchase certain irradiated products. We present this information so that the Secretary understands that we have fully considered the benefits of food irradiation and nevertheless conclude that it should not be included in the Final Rules.
The first reason we oppose the inclusion of irradiation is that the NOSB voted against its use. Although irradiation is included under "processing practices" in the Proposed Rules, irradiation is defined by Congress and the FDA as a food additive. 56 The fact that irradiation is a food additive rather than a processing practice is more than a nuance. As a synthetic food additive, irradiation must be evaluated and approved by the NOSB and placed on the National List in order to be used in organic farming and handling. At the 1995 Orlando, Florida meeting of the NOSB, the Board unanimously voted to prohibit the use of ionizing radiation for the purpose of killing insects or microorganisms in food. As we discuss later in our comment, the OFPA does not provide the Secretary with the authority to add materials to the National List which have not first been approved by the NOSB.57 Therefore, until such time as the NOSB approves irradiation, it cannot be allowed under the National Organic Program.
Second, irradiation has traditionally been prohibited in organic agriculture. We are unaware of any state or private program that allows the use of irradiation at this time. 58 Furthermore, irradiation is prohibited by the IFOAM, and, significant trading partners such as Germany and New Zealand altogether ban it from imported food.59 Certainly, irradiation is a highly controversial issue and an abrupt change in its treatment under the National Organic Program would lead to significant domestic and global market disruption.
Third, viable alternatives to food irradiation exist. Typically, food borne contamination results from improper or inadequate application of disinfection techniques rather than through pathogen resistance or immunity. There are many low cost and readily available disinfection techniques such as heating, refrigeration, use of natural compounds including chlorine, reduction of oxygen and moisture, packaging and hygienic handling — all of which have proven effective in organic handling operations.60 It is important to recognize, however, that these disinfection techniques alone will not provide adequate food safety. Nor will irradiation alone be a substitute for standard hygienic practices. For example, irradiated food is just as susceptible to becoming re-contaminated as non-irradiated food is to being contaminated. The FDA has stated that "Irradiation, although a potentially useful tool for helping reduce risk of food borne disease, is a complement to, not a replacement for, proper food handling practices by producers, processors and consumers."61 Organic handlers understand the importance of management systems based on preventative approaches to pathogenic contamination. At a recent conference on food irradiation, former FDA Commissioner David Kessler decried the lack of a "systematic approach" for the prevention of food safety problems. Indeed, much of FDA's food safety discussions center on the development and adoption of the Hazard Analysis and Critical Control Point (HACCP) safety program.62 Not surprisingly, organic industry leaders have embraced HACCP and are accustomed to developing systems approaches to food safety protection. We recommend that the Secretary require handlers to address food safety issues and practices in their organic handling plans.
Additionally, the Secretary requests comment as to whether particular products would be unavailable if irradiation was prohibited. We are unaware of any particular product for which irradiation is essential. Herbs and spices have been referred to many times as a primary example of a product that is unavailable in non-irradiated form. We have not found this to be the case. Frontier Natural Products Cooperative, a herb and botanical company based in Norway, Iowa, supplies approximately 70% of the bulk herbs and spices used in organic production; the company does not irradiate its products, but takes other necessary precautions to ensure the safety of its products.63 Surely, other companies can (and do) follow similar procedures.
Fourth, there is evidence that consumers strongly prefer that organic foods not undergo irradiation.64 If consumers have the right to purchase foods they know have been irradiated, they should also have the right to purchase foods which they know have not been irradiated. Despite considerable evidence that irradiation can contribute to food safety, we urge the USDA to respect the expressed sentiment of the organic community. To remain a genuine alternative, organic handlers must differentiate their products from conventional products and decide when innovation, however promising, is inconsistent with a low input, low impact approach. Many consumers express a preference for non-irradiated foods and the organic seal has meant, to date, a strict prohibition on the practice. Consumers who rely on certification to identify non-irradiated food would loose that protection under the Proposed Rules.
Fifth, irradiation is not without its problems. The well documented changes which irradiation produces in food provide sufficient justification for consumers to seek non-irradiated options. Even large conventional agriculture companies acknowledge the downside of irradiation. For example, IBP Company spokesperson Gary Mickelson admitted that irradiation darkened meat and changed its flavor in a way that was "noticeable enough" to cause concerns. 65 The depletion of nutrients including as much as 10% of vitamins A, B-1 (thiamine), E, and K is a recognized consequence of food irradiation.66 Irradiation also triggers formation of radiolytic compounds which consumers might wish to avoid.67 While many irradiation advocates are quick to point out that other processing techniques such as deep frying cause similar effects, it is only fair to point out that consumers can and do protect themselves by not eating foods prepared that way. We do not dispute or deny the FDA's and USDA's position on irradiation but believe that many consumers want more proof before they are comfortable with the practice. There are studies, as well, that show food irradiation to be among the more expensive food safety techniques, unnecessary costs that consumers eventually pay when they go to their grocery stores.68 By retaining the prohibition on irradiation which organic standards have long upheld, the National Organic Program can continue to provide a market driven choice on which many consumers rely.
Finally, there are compatibility considerations which cast doubt on the appropriateness of irradiation in organic systems. One has to question seriously how a process which depends on radioactive isotopes fits into the low input, low impact paradigm which embodies organic production. Both the radioactive isotopes permitted for use in commercial irradiation facilities - cobalt 60 and cesium 137 - are by-products of nuclear fission. 69 While cobalt 60 is intentionally produced by placing cobalt 59 inside a reactor core, cesium 137 is an unavoidable decay product of nuclear fission and has a half life of thirty years. Permitting use of these isotopes in the National Organic Program would establish a clear connection and interdependence between organic agriculture and the atomic energy and weaponry industry. The processing, shipment and storage of the radioactive materials constitutes a significant human health risk.70 Current commercial irradiation practices also favor highly centralized, capital intensive treatment facilities which are inconsistent with the decentralized producer and handler initiated practices we associate with organic operations. We are convinced that whatever benefits food irradiation can provide, its nature and structure make it fundamentally incompatible with organic agriculture.
Clearly, food safety must remain a paramount concern and we would not expect the National Organic Program to embody anything less than the Department's standard of excellence in this area. We ask simply that the Secretary recognize that there are many ways to ensure food safety and that organic producers and handlers can, and do, successfully address food safety, freshness and processing concerns without irradiation.71
Section 205.18 Prevention and control of facility pests
The Secretary requests comment (Question #18) on whether only those substances included on the National List of active synthetic substances should be permitted to be used to control pests in certified handling facilities. We believe that under an established order of preference system and with the approval of the certifying agent, it should be permissible for a certified handling facility to use materials not included on the National List so long as the synthetic material would, in no way, come in contact with the certified organic product. Occasionally, certain synthetic materials are necessary for proper facility maintenance. To use a synthetic material for the prevention and control of facility pests, the following conditions should be met: the non-approved synthetic(s) is placed last on the order of preference, the independent certifying agency confirms that all other alternatives have been tried and failed and every possible precaution is taken to prevent contamination of organic product before, during and after treatment. The order of preferences outlined in the Proposed Rules will be useful for pointing handlers towards biological and mechanical pest control practices. Only the documented failure of a good faith effort with these approaches should justify permission to use synthetic treatments. The certifying agent must approve the planning as well as execution of the synthetic treatment and primary consideration must be given to preventing any contamination of organic material. Demonstrative of our commitment to the National List process, we also believe that handlers should be required to use an approved synthetic before one not included on the National List. Such a preference could easily be established as part of the order of preference.
Section 205.19 Prevention of commingling and contact with prohibited substances
We have no concerns regarding the Proposed Rules to prevent commingling and contact with prohibited substances. As certification of handling operations is a relatively new concept, we do recommend that the Secretary sponsor a conference of certifying agents and handlers, FDA HACCP experts, and other appropriate state and Federal regulators to further refine handling standards that are meaningful and workable for organic production systems.
The National List of Allowed and Prohibited Substances
The "National List" is a list of allowed synthetic materials that can be used in organic production as well as a list of natural materials prohibited from organic production. While the basic principle of organic agriculture is reliance on natural systems, there are widely accepted exceptions to the rule. For example, insect pheromones, used as a biological control agent, are difficult to collect in nature so a synthetic analog is produced in the laboratory. And some botantical pesticides, like strychnine and tobacco dust, while natural, are commonly disallowed in organic production systems because they present human health and environmental hazards. State and private certification programs currently have "material lists" that producers and handlers must follow as a condition of certification. Since its first meeting in 1993, the NOSB had lead a national dialogue between organic farmers and handlers, consumers, and environmentalists to build a consensus on what materials should be placed on the National List.
The role of the NOSB
Congress envisioned a partnership between government and private organizations in standard setting and certification. Accordingly, the OFPA requires the NOSB to recommend to the Secretary the universe of synthetic materials acceptable for organic production. In turn, the Secretary can, both before and after public comment, reject synthetic materials for use in organic production from the Proposed National List recommended by the NOSB. The Secretary cannot, at any time, add synthetic materials to the National List that are not first recommended by the NOSB. The language of this statutory provision and the supporting legislative history are crystal clear. The Wallace Institute recognizes that maintaining the integrity of the National List process is essential to the success of the National Organic Program. On behalf of the NOSB, we prepared a legal analysis of the power of the NOSB versus the Secretary to add synthetic materials to the National List. That document was submitted to the Secretary March 25, 1998 and is found in Appendix B of this comment.
As stated earlier, we are concerned that synthetic materials approved by the NOSB for the National List were approved only on the condition that they be used under highly prescribed circumstances. The NOSB provided these use restrictions to the Department but they do not appear in the Proposed Rules. We urge the Department to follow the NOSB recommendations which will severely limit the use of National List materials, consistent with industry norms and consumer expectations.
Additionally, we are confused by the discussion in the Supplementary Information that rationalizes the Department's addition of the synthetic synergist piperonyl butoxide to the National List because it failed to win NOSB approval by only one vote. This demonstrates a lack of understanding of the role of the NOSB, its composition, and the importance of the specific voting procedures dictated by the OFPA. The NOSB and the voting procedures were carefully constructed by Congress and dictated by statute. The Congress established specific voting procedures to ensure that materials decisions would require approval by the organic, environmental, and consumer representatives on the Board.
In 1991, the National Organic Program requested guidance on the criteria for selection of NOSB members. The Organic Trade Association provided extensive input in response to this request.72 We recommend that the Secretary, along with the current NOSB, deliberate further on the selection process for NOSB members. It is important that the Secretary continue to appoint members with sufficient expertise and leadership appropriate to their designated roles.
Section 205.22 Active synthetic substances allowed for use in organic crop production
We recommend that Final Rules respect the material decisions of the NOSB. The NOSB determined that the following materials should either be prohibited, approved with restriction, or tabled for more complete technical analysis.
| Citation in 205.22 | Material | OFPA Reference | NOP Proposed Rules | NOSB Recommendation |
| (b) | soaps | a category of allowable synthetic | allowed as insecticides, algicides, de-mossers, large animal repellants and herbicides | approved as algicides, de-mossers and on non-food crops or area; prohibited as food crop herbicide |
| (c)(1) | acetic acid | none | allowed as pesticide | no position taken |
| (c)(3) | vitamins | a category of allowable synthetic | allowed as growth promoters and rooting facilitators | review and decide on a case by case, not categorical, basis |
| (c)(5) | amino acids | none | allowed as growth promoters | tabled; no position taken |
| (c)(6) | antibiotics | livestock medicines are a category of allowable synthetic | allowed as pesticide | approved specific uses for streptomycin sulfate and terramycin subject to review in two years; prohibited use of avermectin in crop production |
| (c)(7) | magnesium sulfate | none | allowed as cation balancing agent | approved as soil amendment with documented magnesium deficiency |
| (c)(8) | newspaper & other recycled paper products | production aids are a category of allowable synthetic | allowed as mulch and compost feedstocks | approved as mulch but glossy and colored ink paper prohibited |
| (c)(9) | piperonyl butoxide | none | allowed as synergist | prohibited |
| (c)(10) | potassium sulfate | none | allowed as a cation balancing agent | no position taken |
| (c)(11) | boric acid | none | allowed as a pesticide | approved for structural pest control; no direct contact with certified food or crops |
| (d) | non-living GEO toxins | none | allowed as pesticide | prohibited |
| (e)(1) | bordeaux mixes | copper and sulfur compounds are a category of allowable synthetic | allowed as pesticide | approved for use in a manner that minimizes accumulation of copper in soil |
| (e)(2) | fixed copper exempt from EPA tolerances | copper and sulfur compounds are a category of allowable synthetic | allowed as pesticide | approved for disease control; prohibited as an herbicide. Shall be used in a manner which prevents excessive accumulation in soil |
| (e)(3) | lime sulfur | copper and sulfur compounds are a category of allowable synthetic | allowed as pesticide | restricted to use as a fungicide or an insecticide if no feasible alternative exists |
| (e)(4) | sulfur dioxide | copper and sulfur compounds are a category of allowable synthetic | allowed as pesticide | approved for use sulfur smoke bombs for control of underground rodents |
| (g)(3) | sodium chlorate | none | allowed as defoliant in fiber production | prohibited |
Toxins derived from genetically engineered bacteria
The Secretary requests comment (Question #19) on whether to include toxins derived from genetically engineered bacteria on the National List. Such toxins do not belong on the National List because the NOSB did not approve them as allowed synthetics.
The Secretary also requests comment (Question #20) on the potential for such toxins to contribute to accelerated resistance of pest populations. Pest susceptibility to the Bacillus thuringiensis (Bt) toxin is an extremely valuable public good that is threatened by overuse. Organic farmers are particularly troubled by growing Bt resistance. 73 In large part, the NOSB rejected the Bt toxin derived from genetically engineered bacteria on the basis of resistance problems. We agree: the use of killed microbial Bt toxins poses an unwarranted risk of accelerated resistance and the ultimate loss of valuable active ingredients.
The Bt toxin is remarkable among pesticides for its ability to kill economically important insect pests without harming most other organisms. Bt is one of the few insecticidal toxins allowed under many organic certification programs. According to the USDA's National Agricultural Statistics Service (NASS) reports for 1994, Bt sprays are widely used on many vegetables and fruits. For instance, Bt was the most commonly applied insecticide to fresh cabbage, processing spinach, eggplant and snap peas. It was the third most commonly applied insecticide to fresh spinach and green peppers.74
Numerous papers document the problems of accelerated resistance that comes from use of Bt in foliar, genetically engineered toxin and transgenic formulations. 75 We are especially concerned by the introduction of transgenic Bt crops including corn, cotton and potatoes which provide continuous exposure. Constant pest exposure to Bt is the perfect recipe for accelerated resistance. The Wallace Institute urges the USDA to shift research dollars to find solutions to Bt resistance. A 1996 search of the USDA Current Research Information System (CRIS) found that 12% of all Bt research projects were on resistance management and that the progress reports on these projects did not point in a clear direction for resistance management.
Biosolids (sludge)
The Secretary requests comment (Question #21) on whether the use of biosolids should be permitted or prohibited in organic production and if biosolids should be classified as synthetic or non-synthetic materials. Biosolids, often referred to as sludge, are partially treated organic compounds produced by municipal wastewater facilities. We fully support the position taken by the NOSB that biosolids are synthetic materials and that national organic standards should expressly prohibit them. In addition to the historical prohibition on their use in domestic and international standards, there are environmental and human health considerations which weigh against approving biosolids at this time. Fundamental weaknesses in existing regulations, as well as some troubling loopholes, lead us to believe that even state of the art biosolids production cannot consistently and reliably conform with organic standards.
The USDA, EPA and FDA have made a commendable effort to safely utilize biosolids in conventional agricultural, but we believe that current federal regulatory procedures are incapable of satisfying organic criteria. In 1993, the EPA adopted regulations on biosolids management that created Class A sludges which are treated to eliminate pathogens and Class B sludges in which pathogens are reduced but still present.76 No organic contaminants are currently regulated. The EPA also established standards for 10 heavy metals (arsenic, cadmium, chromium, copper, lead, mercury, molybdenum, nickel, selenium and zinc). The EPA uses a two tier standard which sets a desired baseline concentration and an elevated acceptable level. Class A sludges which meet the desired standard for all ten metals are classified as Excellent Quality or EQ and can be applied without restriction in quantity or duration in any agricultural, horticultural or landscaping situation. Non-EQ Class A sludges and Class B sludges cannot be sold without restrictions on their use and applicators are required to monitor where and how much they use. There are no federal permits required to land apply any Part 503 approved biosolids. Individual states may impose additional restrictions but cannot relax any provision in Part 503.
Environmental impacts weigh heavily in the argument against using biosolids in organic agriculture. We question the sustainability of deliberately adding heavy metals to farm land on the premise that an acceptable or allowable level of contamination exists. This practice appears inconsistent with the system of organic farming definition presented in the Proposed Rules which emphasizes maintaining long-term soil fertility. Although the contaminants permitted in sewage sludge have known detrimental effects on soil microorganisms, the Part 503 risk assessment did not set limits on heavy metal concentrations based on the impacts on soil microorganisms. 77 At higher concentrations, many plants, and the animals that graze on them, can be adversely affected.78 We are also concerned about the potential spread and persistence of microbial pathogens which are allowed in Class B sludges. The uncertainty surrounding the exact composition of a biosolids product and the known presence of deleterious materials combine to make them unsuitable for the very sensitive, site specific management practices necessary in organic agriculture.
The use of biosolids creates risks to human health which are inconsistent with the conservative, protective nature of organic production. The EPA used an unacceptably low one in 10,000 standard as an acceptable cancer risk when establishing contaminant levels for Part 503 regulations.79 Compared with the one in 1,000,000 safety factor used in 1996 Food Quality Protection Act, the one in 10,000 standard provides consumers a minimal level of protection. Other variables in the risk assessment, such as plant uptake coefficients, exposure through multiple pathways and dietary intake, were calculated in ways which permit excessive concentrations of contaminants in biosolids applied to food crops. Even using the lower concentrations found in Class A EQ sludge, the Part 503 standards allow for significantly higher levels of heavy metal than European standards for all contaminants but lead.80
The EPA is remiss in not regulating biosolids for contamination from organic pollutants. One of the great deficiencies in the production of biosolids is the inability to adequately screen source material for undesirable substances. Because treatment plants typically receive both industrial and residential wastewater, many solvents, chemical by-products and hydrocarbons are routinely found in the dry sludge used to make biosolids. Very often, storm water drains are also linked to treatment facilities, creating another uncontrollable vector for contamination. However, in developing the Part 503 standards, the EPA dismissed setting standards for any organic contaminant because none appeared in more than five percent of the samples included in its 1988 National Sewage Sludge Survey. Currently, the EPA is conducting a second round of standard setting, but will not write regulations for any material occurring in less than 10% of samples. We must point out that the frequency of contamination in no way reflects its potential for harm and that without standards and testing there is no way to practice quality control on biosolids. Contaminants such as asbestos or dioxin from site specific sources could enter a treatment facility in wastewater and become concentrated in the untested biosolids that ultimately leave the plant.
The EPA has also been delinquent in regulating biosolids for hazardous materials which are no longer manufactured or approved for use in the United States. For example, Part 503 contains no standard for PCBs even though these materials are known contaminants, are slow to degrade, and bioaccumulate in humans. The FDA has established a workable policy for an analogous problem by setting action levels for de-regulated but persistent pesticides. In its review of current biosolids practices, the National Research Council stated that "The EPA should not exclude chemicals from regulatory consideration based solely on whether or not those chemicals have been banned from manufacture in the U.S. since they are still found in sludges from many wastewater treatment plants."81 The EPA has created genuine cause to question the safety of land applied biosolids through its lax standards for heavy metals and its failure to regulate for any organic contaminant. Overall, we are uncomfortable with the human health risk assessment behind Part 503 and find it fundamentally incompatible with the practice and principles of organic agriculture.
There are also factors pertaining to compatibility with organic systems which support our position to prohibit the use of biosolids under National Organic Program standards. While we support environmentally sensitive recycling of organic matter, we are concerned that low cost biosolids products could flood the organic fertilizer market. The tremendous increase in biosolids production over the past decade is directly related to the availability and expense of alternative practices.82 Many treatment facility operators, and especially those in densely populated areas with large volumes of organic wastes, are willing to sell their finished biosolids at below cost to avoid the expense of incineration or landfilling. Approving biosolids for organic systems would discourage producers from developing on-farm nutrient management strategies based on crop rotations featuring legumes, composted animal manures and other natural substances. Biosolids constitute a subsidized, synthetic substitute and are contradictory to the de-centralized, self sufficient approach which should characterize organic nutrient management. We do not object to producers looking off the farm for critical production needs. However, using an imported product of questionable quality should not be an acceptable alternative to either meeting the need on the farm or bringing in a product of known quality.
We appreciate the effort the USDA, EPA and FDA have made to find acceptable uses for biosolids and are fully supportive of the principles behind their actions. There are other examples of products, including medicines, pesticides and fertilizers, which are approved for general use by the three federal agencies but prohibited under the Proposed Rules. Because of the widely recognized and unavoidable contamination of dry sludge with industrial wastes and by-products, biosolids clearly need to be classified as a synthetic material. Under the OFPA criteria for allowable uses of synthetic materials, we find no reasonable justification to allow the use of biosolids in organic agriculture. In addition to the NOSB prohibition, unacceptably high levels of known contamination and unresolved quality control issues make biosolids an environmental and human health risk which should not be permitted in organic agriculture. Given the potential adverse impact on soil microorganisms, we consider the deliberate application of heavy metals in excess of a crop's nutritional requirements unsupportable as an organic practice. We also believe that the term biosolids represents far too broad a category of materials to be considered collectively and, that in the future, more narrowly defined parameters be established for any material under consideration for inclusion on the National List.
Inert materials
Under the FIFRA, a material, regardless of its toxicological affect or environmental impact, is classified as inert if it is not a primary active ingredient. The EPA categorizes all potential inert materials into one of four categories:
List 1: Inerts of Toxicological Concern
List 2: Potentially Toxic Inerts / High Priority for Testing
List 3: Inerts of Unknown Toxicity
List 4: Minimum Risk Inerts
In evaluating which materials to permit as allowable synthetics, the Secretary indicates that he will exclude only List 1 inert materials. This decision is based on congressional directive which allows use of synthetic inert ingredients not classified by the EPA as being of toxicological concern.83 We are well aware of the confidential business information problems presented by inert materials and understand that outlawing whole categories of inert materials, until such time as we are provided more detailed information, is the logical way to proceed. However, we are concerned by the inclusion of all List 2 materials. A 1998 study identified over 300 List 2 and 3 inert ingredients with sufficient toxicity to also be registered as synthetic active ingredients. Examples of List 2 inert materials which the Proposed Rules would allow in organic pesticide and non-pesticide formations include toluene, methyl bromide and ethyl benzene.
Eventually, the NOSB must undertake a case by case review of all synthetic inert materials. The NOSB has begun to contemplate this task:
Inerts on the EPA List 4 are considered to be generally regarded as safe and will be accepted for organic production, unless an NOSB evaluation finds a specific List 4 inert to be unacceptable. Inerts proposed for organic production on the EPA's List 2 which are potentially toxic and List 3 which are unknown will be compiled by the NOSB and forwarded to the EPA as materials for fast-track review and possible reclassification. 84
We recommend that Final Rules find a way to facilitate a case-by-case review process for List 2 and 3 inerts. The private certification community has already established a viable precedent along these lines. The Organic Materials Review Institute (OMRI) is a non-profit institution established by 16 certification agencies to review inert ingredients. To have a compounded pesticide product certified for organic use, the manufacturer provides the OMRI the confidential ingredients list which is screened on the following basis: List 1 inerts are prohibited, List 2 are prohibited unless explicitly allowed, List 3 are reviewed on case by case and List 4 are allowed unless specifically prohibited. This private sector initiative protects the manufacturer's proprietary formulas, provides the certifying agents the comprehensive information they need, and builds consumer confidence that health and safety considerations are thoroughly addressed. If this process is not adopted by the Secretary, some solution to the inert issue must be found: no issue has been of more concern to the environmental community which supports organic standards.
Section 205.23 Non-synthetic substances prohibited for use in organic crop production
The NOSB identified ash from manure burning, sodium fluoaluminate from mined sources, strychnine and tobacco dust as non-synthetic materials and recommended their placement on the Prohibited Naturals List. The Proposed Rules prohibit the use of ash obtained from the disposal of manure by burning under Section 205.7(d)(2). In the Supplementary Information, the Department identifies tobacco and tobacco by-products as one of the materials it reviewed but elected not to include on the National List. The Department states that it reviewed both strychnine and sodium fluoaluminate but that neither material met the dual criteria of being harmful to human health and the environment and inconsistent with organic farming and handling. We disagree and urge the Secretary to follow the recommendations of the Board.
Section 205.24 Livestock production substances
The USDA has expanded the OFPA's two categories to six for active synthetic substances allowed for use in organic livestock production: trace minerals, nutrients and dietary supplements, feed additives (if also included in Section 205.26), animal drugs and other animal health care substances, vaccines and biologics, and pest control substances (if they are also included in Section 205.26). While by no means synonymous, the sub-categories of trace minerals, nutrients and dietary supplements, and feed additives are related to the OFPA allowance of vitamins and minerals. We do not oppose a reasonable expansion of the OFPA language as long as it does not lead to use of a variety of synthetic alternatives to certified feed, forage and pasture. To help clarify this issue, we recommend that the Final Rules incorporate the definitions for feed, feed supplement and feed additives adopted by the NOSB.
The extension of the OFPA's allowance for parasiticides and medicines to include animal drugs and other animal health care substances as well as vaccines and biologics has blurred the lines surrounding what materials are allowable and how they can be used. In the Supplementary Information, the Secretary explains that he will use the term "animal drug" to encompass medications, antibiotics and parasiticides. We believe that this blanket exemption for all conventional animal drugs is too broad and is inconsistent with historical organic practice.
Section 205.25 Non-synthetic substances prohibited for use in organic livestock production
Neither the NOSB or the NOP identified any substances within this category.
Section 205.26 Non-agricultural (non-organic) substances allowed as ingredients in or on processed products labeled as organic or made with certain organic ingredients
The following materials proposed for inclusion on the National List should be removed because the NOSB did not approve them. These materials were either never approved, approved with restrictions or prohibited:
Chymosin
The Secretary requests comment (Question #22) on whether the genetically engineered enzyme chymosin should be included on the National List of non-agricultural materials. Chymosin does not belong on the National List because the NOSB did not approve it as an allowed synthetic. Furthermore, the Organic Trade Association has determined that sufficient natural alternatives are available at acceptable prices to prohibit use of this genetically engineered rennet.85 The Organic Materials Review Institute, another leading voice in the organic community, places synthetic chymosin on its prohibited list.86
Section 205.27 Non-organically produced agricultural products allowed as ingredients in or on processed products labeled as organic or made with certain organic ingredients
This provision is consistent with the OFPA.
Subpart C
Labels, Labeling and Market Information
General comments
The market for organic products has grown at the rate of 20% to 25% per year for approximately the past 10 years. Industry analysts predict it will continue to grow at a rate equal to or exceeding 20% to 25% percent each year for the next five to 10 years. 87 Consumers have always demanded food that tastes good, looks good and is good for their families. They are increasingly demanding food that is safe and environmentally-friendly as well. In attempting to meet these new consumer demands, food industry businesses have created a variety of 'alternative' products. These products are grown, manufactured, packaged, marketed and/or distributed in ways which distinguish them as safer and more environmentally-friendly than their counterparts in the mass market.
These 'alternative' products are identified by handlers through the use of labels and marketing techniques. Labels enable handlers to communicate to consumers exactly what work has been done in order to meet consumer demand. Labels benefit consumers by giving them the information they need to make informed decisions in the marketplace, and the majority (57%) of all shoppers nationally think it is very important to have an organic seal. They also say that a national organic seal would make them more likely to purchase organic produce (54%), organic meat and poultry (51%) and processed foods labeled as organic (43%). 88 This impressive degree of consumer interest has prompted many organic food industry businesses to become certified so that they can use labels that convey their exact production processes to the consumer. It is vitally important for both consumers and organic food industry businesses that the ability to truthfully label and market products as organic remain intact.
Trademarks
At the most recent NOSB meeting it was pointed out that several companies have already incorporated the term organic into their company name or logo. A concern was raised that with pending label restrictions on the term organic, additional companies may rush to the Patent and Trademark Office for approval of trademarks that use the term organic in various ways. We ask the Secretary to advise the Patent and Trademark Office of forthcoming organic labeling restrictions. If examiners are educated on the intent and content of pending regulations under the National Organic Program, they will be less likely to approve trademarks which might circumvent the intent of the OFPA.
Section 205.100 Agricultural products in packages sold, labeled, or represented as organic
The provisions in Section 205.100 establish labeling requirements for products containing more than 95% organic content. We concur with the conditions set forth for use of the USDA seal but recommend that seals of state programs and certifying agents be treated similarly. In the Proposed Rules only state seals can appear on the primary display label. We recommend that the Secretary determine whether state and private seals are best placed on the primary display or information label and impose identical restrictions. Private seals are widely recognized and respected and their presence is sought by many consumers. Both state and private certifying agents should retain equal rights to identify themselves by name and emblem. The Secretary requests comment (Question #24) on the proposed provision to identify on the information panel only the agency which certified the finished product and not any additional agencies which may have certified particular ingredients. We agree. It is unnecessary to identify more than the certifying agent of the finished product, since that agent is responsible for the documentation of the product from the start of the production process. Multiple identifications may confuse consumers and possibly suggest super-organic status. As stated in our comments on Section 205.104, we do not concur with percentage prohibitions and recommend that all organically produced ingredients be designated on the ingredient panel, perhaps by an asterisk since products in this category will likely contain many such ingredients.
Section 205.101 Agricultural products in packages sold, labeled or represented as made with certain organic ingredients
The Secretary requests comment (Question #25) on the proposed use of the term "made with certain organic ingredients" on the principal display panel of products that contain between 50% and 95% organic ingredients. We are concerned that use of a generic organic ingredients term will not adequately convey crucial information which consumers seek. The term would even be misleading if the product contained only one organic ingredient. The proposed provision represents a significant step backwards from current labeling practices which identify specific organic ingredients. We support the NOSB recommendation adopted in Ontario, California in March, 1998 to change the term "made with certain organic ingredients" to "made with organic (ingredients)," ingredients being comprised of up to three different individual ingredients used in the food product. We also support the NOSB recommendation to restrict the organic statement font size to no more than 3/4 the size of the product name on the principal display panel. Allowing an organic claim for up to three individual ingredients on the principal display panel will enable producers and handlers to convey more thoroughly the nature of their product. For example, "chile made with organic tomatoes and organic beans" is clearer (and more appealing) than "chile made with certain organic ingredients." Restricting the font size of the label claim on products containing between 50% and 95% organic ingredients also will help distinguish this category of products from those containing greater than 95% certified ingredients. We believe that the "made with organic (ingredients)" provisions recommended by the NOSB are best suited to educate and protect consumers while providing producers and handlers reasonable flexibility to make verifiable label claims. We also recommend that the ingredient panel specify which ingredients are organically produced.
Section 205.102 Multi-ingredient agricultural products that only represent the organic nature of such ingredients in the ingredients statement
We concur with the Secretary that the term organic should not appear on products which contain less than 50% organically produced ingredients other than to identify the organically produced items on the ingredient statement. Slightly over half of all consumers say they "always" read nutrition labels when they buy food products for the first time. Almost 40% say they appreciate ingredient lists. Over 60% report that they have changed purchases because of information on the product nutrition label.89 These findings corroborate our assumption that consumers read nutrition and ingredient labels to gather more information about products — and that they make decisions based on what they find on such labels. The ability of handlers to identify organically produced items on the ingredient statements of their products will be a valuable marketing tool.
The three tier system insures that the prominence of the label claim and its marketing value will be directly proportional to a product's organic content. This system rewards producers and handlers who maximize the organic content in their products and discourages token use of certified ingredients to exploit the label claim.
Section 205.103 Use of terms or statements that directly or indirectly imply that a product is organically produced and handled
We ask that this section be struck in its entirety for six reasons.
First, the Secretary has provided insufficient notice of his intent under this section. The Secretary requests comment (Question #26) from the public as to what terms or phrases other than "organic" or "made with certain organic ingredients" they believe could directly or indirectly imply that a product was organically produced and handled and the rationale for the allowance of their use. The limited discussion in the Supplementary Information makes it impossible to determine the scope of the Secretary's concern, leaving the public to guess as to what ecolabels merit attention beyond the list provided in the Supplementary Information.90 As currently written, this section provides insufficient notice to producers and handlers regarding the proper scope of labeling strictures.
Second, without knowing what the Final Rules on organic standards will be, we can only speculate on the degree to which certain terms listed in the Supplementary Information may relate to USDA approved organic production claims. Will the Secretary limit use of synthetic substances to those now on the National List? How will inert materials be regulated? Will the Secretary further restrict use of antibiotics? Will the Secretary require soil-building crop rotations so essential for the ecological health of the farm system? The questions go on and on. Not only is the Secretary's question on ecolabeling misplaced within the context of a proposed National Organic Program, the very relationship he seeks to understand is impossible to decipher at this juncture in the rulemaking process.
Third, the Federal Trade Commission (FTC) is actively involved in assessing various ecolabel claims and prosecuting abuses as necessary. The Secretary should work closely with the FTC before the Department launches into this issue. The FTC has published a Guide for the Use of Environmental Marketing Claims in which it advises on how to avoid violations of Section 5 of the Federal Trade Commission Act which prohibits unfair or deceptive advertising claims. The Guide highlights four basic principles: "that claims be sufficiently clear and prevent deception; that they clarify whether or not they pertain to the product; that they not overstate an environmental attribute or benefit; and that comparative claims be presented clearly so as to avoid consumer deception".91 Under the FTC guidance, the ecolabels listed in the Supplementary Information would appear to be in compliance.
Fourth, most of the terms listed in the Supplementary Information have little or nothing to do with organic production. The Wallace Institute welcomes an inquiry into the affect of the growing number of ecolabels on the food industry and consumers. Our research indicates that the Secretary is rightly concerned that certain labeling claims may be misleading or contradictory. However, we believe an inquiry into this issue is misplaced in the Proposed Rules. For example, the Secretary contemplates prohibiting the term "sustainably harvested," a labeling claim of great importance to fisheries and consumers concerned with over-harvesting the seas. Is is unlikely that fishermen and related industry businesses would know to search a lengthy Federal Register Notice on organic standards for ecolabeling provisions that could destroy their markets.
None of the terms and phrases which the USDA identifies as potentially misleading presents a sufficient risk to the meaning of organic to merit its prohibition. It is highly unlikely that a production trait claim (i.e., "pesticide-free farm","produced without synthetic hormones") could be misconstrued to convey the systemic approach which characterizes organic agriculture. The definition of a system of organic production in the Proposed Rules recognizes the comprehensive and integrated nature of organic agriculture and we believe that most consumers share this understanding. Though particular phrases or statements regarding pest control, nutrient management, post-harvest handling or animal welfare may conform with organic practices, they do not suggest or imply that all components of the production system conform with organic practices. The system based claims (i.e., "ecologically produced","humanely raised") are unlikely to be misleading. While "ecological" and "biological" have been frequently used in recent years to describe alternative agricultural systems, there are no certification standards or seals for these terms comparable to the state and private systems which exist for organic. While these terms often share characteristics which consumers associate with organic production, they are not sufficiently codified or standardized to constitute a legitimate alternative and as such will not infringe upon the accepted meaning of organic. A genuine alternative system that has established its credibility and market share should have the right to function independently, alongside the National Organic Program. A case in point is the biodynamic farming system which carries its own label. This term represents an agronomic system that is codified, recognized and distinct from organic agriculture.
Fifth, Congress never intended for the OFPA to prohibit and/or regulate various forms of ecolabeling. At the time the law was written, Congress was aware of bogus organic claims and intent on cracking down on misuse of the organic label. As a result, the OFPA required the Secretary, in consultation with the Secretary of Health and Human Services, to insure that "no person may affix a label to, or provide other market information concerning, an agricultural product if such label or information implies, directly or indirectly, that such product is produced and handled using organic methods, except in accordance with this title."92 The National Organic Program was established to restrict use of the terms organic, made with organic (ingredients) and other derivatives such as "organically grown" or "organically produced." Beyond that, there was limited discussion of the claim "pesticide free", prompted by queries from NutriClean, a California-based company that certifies produce as "pesticide free" and a suit won by the Federal Trade Commission against a major supermarket chain for use of an unsubstantiated "pesticide free" claim. The Congress was concerned that some consumers fail to distinguish between "pesticide free" and "organic", despite clear differences and, as a result, directed the Secretary to evaluate the "pesticide free" claim.93 Other than "pesticide free", Congress raised no concerns over various ecolabels. Indeed, consumer interest in "natural" and "no antibiotics and hormones" labels was raised not as a concern but as exciting evidence of the burgeoning consumer demand for food produced under alternative systems.
Sixth, the Federal courts have consistently protected commercial free speech as long as such speech concerns lawful activity, is not misleading and there is no compelling governmental interest in imposing speech restrictions. None of the terms or phrases identified in the Supplementary Information could be interpreted as illegal. As to their potential to mislead, there is no evidence that the terms "ecologically produced", "sustainably harvested" or "humanely raised" imply to consumers that products were organically produced or handled; indeed, nonorganic products can be produced in an ecologically sound, sustainable and humane manner. Should the Final Rules prohibit the use of these terms, the restriction would almost certainly run afoul of existing First Amendment doctrine. The Supreme Court recently addressed a similar issue in the context of federal restrictions on beer labeling. See Rubin v. Coors Brewing Co., 514 U.S. 476 (1995). In its unanimous decision invalidating a governmental prohibition on displays of alcohol content, the Court stated, "[A] governmental body seeking to sustain a restriction on commercial speech [such as a labeling law] must demonstrate that the harms it recites are real and that its restrictions will in fact alleviate them to a material degree." Rubin v. Coors Brewing Co, 514 U.S. at 486. Thus, before the government can proscribe any labeling, it must demonstrate that the restriction will "directly advance the governmental interest and be no more extensive than necessary to serve that interest." Id. At 484. This will be a very difficult burden for the government to sustain. The only conceivable justification for restricting ecolabels is to avoid consumer confusion, presumably the concern that consumers seeing an ecolabel of some sort will mistakenly assume that the product was organically produced.
But there is no substantive evidence of such confusion. As stated earlier, there has been no conclusive research that supports this assumption.94 As far as we know, research as not been conducted on the topic of possible consumer confusion regarding organic and other "green" labels. Many of these other labels are new and have not permeated markets. Therefore large numbers of consumers have not been exposed to their seals and claims. We must assume, for the reasons explained above, that these labels are not being confused with organic labels, but only consumer surveys can substantiate our assumption. We urge the Secretary to encourage attention to, and funding for such research.
Section 205.104 Informational statements prohibited
The Secretary requests comment (Question #27) on the proposal to allow a statement of the percentage of organic ingredients on a product package and on the proposal to prohibit its use on the principal display panel and in the ingredients statement of products containing organic ingredients. We believe that accurate and verifiable percent organic claims are a valuable marketing technique and provide a strong incentive for producers and handlers to increase the amount of organic ingredients they use. Consequently, we disagree with the Secretary's proposed prohibition of use of the statement 100% organic. The NOSB recommended allowing the 100% organic claim on the principal display panel for products containing solely organic ingredients, subject to verification. As well, the NOSB recommended making the percentage of organic content an optional element on the ingredients panel, if producers and handlers can guarantee that such content claims are true and consistent. The Board correctly placed responsibility for determining the total percentage of organic ingredients with the handler subject to verification by the certifying agency and spot checks by the National Organic Program. We strongly recommend that the Final Rules incorporate the position on percent organic content adopted by the NOSB. At a minimum, the Secretary must exempt fiber products from the percentage statement prohibition because other statutes require such percentages to be listed. 95 Finally, we concur with the Secretary that the phrase "organic when available" or terms of similar meaning should be prohibited.
Section 205.105 Agricultural products in a form other than packages that are sold, labeled, or represented as organic or made with certain organic ingredients
We concur with the Secretary on this section. The provisions are consistent with the OFPA and provide a framework for identifying non-packaged (bulk) organic products in retail environments.
Section 205.106 Agricultural products produced on an exempt farm or handling operation
We concur with the Secretary on this section. The USDA seal, certifying agent seal, or any other information that represents a product as certified should not be used by those small producers and handlers who take the option to exempt themselves from mandatory certification because they gross less than $5,000 annually. Nor should the products from exempted operations be labeled in processed foods as organic.
Section 205.107 The USDA seal
Sections 205.100 and 205.101 of the Proposed Rules establish important distinctions between agricultural products represented as organic and those represented as made with certain organic ingredients. Although we favor modified label language for the latter category, we fully support distinguishing between products which exceed 95% organic content and those with organic content between 50% and 95%. The USDA seal is a useful way of communicating this distinction for consumers. The Proposed Rules would restrict use of the USDA seal to only those products exceeding 95% organic content. This seal will become a national symbol of high-content organic products and may create an incentive for producers and handlers to strive for 95% organic content. We agree that use of the certification seal should be discretionary. Producers and handlers may find valid reasons to comply with National Organic Program standards but not want to display an organic seal; they should not be required to do so.
The Secretary requests comment (Question #28) on the design of the USDA seal and whether it will readily identify an organic product as one that meets the requirements of the National Organic Program. Several aspects of the design may create consumer confusion. The underlying triangle symbol is internationally associated with a warning of danger and should not be used in conjunction with the organic seal. Second, the banner containing the term "organic" should not run diagonally. Diagonal lines inside circles have become popular representations of the message "no" or "not." Finally, the language used in the proposed seal is cumbersome and not representative of existing terminology with which consumers are familiar. The omission of the word "certified" or "certification" deprives the label of widely recognized language which almost all current organic seals utilize.
If, as we recommend, the Secretary reproposes rules for the National Organic Program it would provide an opportunity to conduct a national competition to design an organic seal. A national competition would bring considerable attention to the start up of the National Organic Program. Private sector organizations such as the Chefs Collaborative and the National Campaign for Sustainable Agriculture may be helpful in announcing and promoting the contest. A competition could extend beyond the deadline for public comment because, by the Department's own estimate, the seal will not actually be used until six months after publication of the Final Rules. An open competition to design the national organic seal would generate considerable enthusiasm and epitomize the type of public/private collaboration we expect of the National Organic Program.
Subpart D
Certification
General comments
The establishment of the NOP means that, for the first time, producers and handlers who wish to make an organic claim will have to follow nationally recognized practices to the satisfaction of an independent certifying agent. This will end the confusion which uncertified products have brought to organic markets. Consumers can now be confident that organic certification derives from a uniform and enforceable set of standards.
Existing certification agents have the credibility, expertise and familiarity with conditions in the field to insure the quickest possible implementation of the NOP once standards are finalized. To make the public/private partnership meaningful, the NOP must treat state and private certification agents as more than contract help. The Proposed Rules needlessly diminish the role of certifying agents in making field based and site specific determinations regarding certification. A successful NOP is dependent on a cooperative partnership with certifying agents and should include these agents in the decision making process involving program implementation. For example, certifiers should be allowed greater discretion to collaborate with producers and handlers to develop comprehensive, workable and enforceable management practices. To have this discretion, inspectors need some very specific powers Subpart D denies them, including the authority to terminate certification.
Expense measured in both time and money will largely determine who elects to apply for certification. Producers and handlers, especially the many small scale operators, will seriously question the value of certification if it seems bureaucratically burdensome. For consumers, standards which they cannot understand or which they feel are not enforced are not a worthwhile investment. Cost will influence both sides, with producers and handlers worried about fees relative to profits and consumers wondering how much of the organic price premium is simply paying for the label. While most of the public debate involving the Proposed Rules has centered on its production and handling standards, certification will likely play as important a role in the long term viability of the NOP. Significant changes are needed in the current proposal to insure that certification is an affordable and workable process for producers and handlers.
Section 205.201 What has to be certified
Section 205.201 of the Proposed Rules contains an unwarranted extension of the requirement for certification to handlers who provide contract services to three or more certified operations. The Secretary requests comment (Question #30) concerning the potential impact of this requirement on handling operations which engage in contractual services on certified products. We believe that the 1994 NOSB recommendation for handler certification provides an excellent framework. The NOSB would protect the integrity of organic processing by creating a valid audit trail without the needless expense and burden of certifying every operation which touches a certified product. The NOSB noted that the OFPA's definition of handler as "any person engaged in the business of handling agricultural products, except such term shall not include final retailers that do not process agricultural product" was broad enough to include virtually anyone who helped move food from the field to the shelf. 96 However, the OFPA only requires that handling operations, not handlers, need to be certified. The OFPA defines handling operations as those operations (again, exclusive of final retailers of agricultural products who do not process them) that "(A) receive or otherwise acquire agricultural products and (B) process, package or store such products." The NOSB interpreted to "receive or otherwise acquire" as synonymous with taking legal title to the product. This interpretation created a distinct, verifiable threshold which clearly identified those operations needing to be certified and those that did not.
Under the NOSB's recommended structure, handlers who take legal title to organic products assume responsibility for their subsequent handling and are required to have their operations certified. Any handler who works on organic products without taking legal title would have his activities approved and monitored by the certifying agent responsible for the product when it arrived at his door.97 Non-certified handlers who wanted to serve organic customers would quickly learn to provide the quality control and accountability requirements which certifying agents expect to see. We believe there are many conventional handling operations which would welcome the opportunity to serve the growing organic sector but who are not prepared to go through an extensive certification process with which they are unfamiliar. The transfer of legal title criteria creates an automatic paper trail to insure that certified goods are always in the hands of certified handling operations. The USDA recommendation in the Proposed Rules to limit exemptions to handlers contracting with no more than two certified operations needlessly restricts commercial activity, invites an excessive amount of paperwork related to certification applications, and provides no greater assurances for quality control.
Section 205.201 also outlines certification requirements for organic operations selling or handling products containing between 50% and 95% organic ingredients and those containing less than 50% organic ingredients. We concur with the position the Department has taken to require certification for operations selling or handling products containing greater than 50% organic ingredients. When the word "organic" appears on the principal display panel, the handling operation must be certified. Conversely, when the organic claim is restricted to the ingredient label, the handling operation should not require certification. We believe that significant differences in allowable uses for the organic label claim justify the additional requirement for products containing a majority of organic ingredients. 98 The great disparity in the location of the organic claim and its associated marketing benefit dictates that products exceeding 50% content meet a higher quality control standard.
Section 205.202 Exemptions and exclusions from certification
The Secretary requests comment (Question #31) as to whether the current statutory limitation of $5,000 for certification is appropriate or whether it should be raised. Since OFPA was passed in 1990, both the number of producers and handlers involved in organic agriculture and the volume of their sales have grown consistently. Sales of organic agricultural commodities nearly quadrupled between 1990 and 1996 and many small operations grew accordingly.99 Simply adjusting for inflation makes $5,000 in 1990 worth $6,025 today.100
In the eight years since passage of the OFPA, the very definition of "small farm" has changed. We recommend that the exemption from certification apply to producers and handlers who annually sell no more than $10,000 of agricultural products. The exemption issue needs to be evaluated in the broader context of program costs and what role the Department foresees for small scale operations in this industry. A $5,000 exemption level is too low considering that such income is less than half the poverty level for a family of four; we would expect only part time or hobby farmers to take advantage of it. Small enterprises represent a significant portion of the total number of organic operations but they are a very poor resource for trying to fund the NOP.101 We are concerned that the proposed fixed rate application fee and the increased costs which certifying agencies will have to pass along to their customers will discourage small, family farms from becoming certified. The periodic mandatory residue testing is yet another expense the small operation must bear. There is simply an inadequate profit margin for small producers and handlers to assume the same certification costs as their larger competitors.
We urge the Secretary to seek a statutory increase in the exemption level to $10,000 and create a sliding fee scale to insure that small farms do not pay a disproportionate share of the costs of the program. The intent of our recommendations is to insure that small operations, which most often are family farms connected to a local economy, are not prohibited from participating in the NOP. We recommend that the NOSB examine the relationship between cost and participation to insure that small scale operations are not precluded from certification and the benefits of the organic claim solely by cost.
Many of the comments we have reviewed have questioned the Department's application of the $5,000 exemption to handlers. While the OFPA does not specifically identify handling operations under the Small Farmer Exemption, we believe that including them is a reasonable and workable interpretation of the law. The OFPA language provides an exemption to "persons who sell no more than $5,000 annually in value of agricultural Products" and we see no reason why this should not include handlers. We also recommend that the NOP develop a new category of exemption of up to $10,000 for on-farm processing. This exemption would apply to value added made on site such as maple syrup, jams and relishes and would allow individuals to combine their production and handling exemptions.
The Secretary requests comment (Question #32) on the proposed exemptions from certification and others which might be appropriate for activities related to retailer handling, repackaging and display of certified products. This subject will have considerable impact on consumer confidence due to the potential for intentional or accidental misrepresentation of a product as organic during the retailing process. The examples of bagging bulk organic items or washing and displaying organic produce discussed in the Supplementary Information reflect how many steps are involved in putting a product on the shelf. We believe that experienced and qualified certifying agents are best suited to determine the exact requirements of the organic handling plan based on their site inspection.
Section 205.203 General requirements for certification
Producers and handlers should be required to apply for certification on an annual basis. Under the Proposed Rules, however, operations receive a continuation of certification simply by submitting updated information. The Proposed Rules would make certification an open-ended process with the operation, and not the certifying agent, largely in control of re-approval of certified status. Existing state and private sector certifying agents most commonly award certification for a fixed period of time with one year intervals being typical. With no expiration date on their certification, operations would enjoy considerable leverage in their relationships with certifying agents. The certifying agent must have the authority to require every operation to meet the requirements of certification on a timely and regular basis. The accepted and effective way to do this is to award certification for a one year period and to require operations to apply for renewal. We strongly recommend that the Department amend the Proposed Rules to require producers and handlers to apply for renewal of certification annually.102
Section 204.204 Applying for certification
This section contains a list of the materials which an applicant is required to submit to a certifying agent. We agree on the need for every item currently on the list including the requirement that applicants submit the names of other certifying agents they may have applied to and the outcome of those efforts. In recognition of the important role of third party certifying agents, this section should include a provision that applicants provide "other information as deemed necessary by the certification agent to determine compliance with the Act and the regulations in this part." Certifying agents need this authority to insure that applicants are fully cooperative and responsive throughout the certification process.
Section 205.205 Organic plan
The Proposed Rules for creating an Organic Plan are insufficient. Unfortunately, the organic plan requirements are consistent with the weaken definition of an "organic system of production" found in the Proposed Rules which undervalues the comprehensive, integrated nature of organic systems. The OFPA identified very specific considerations to be addressed in the Organic Plan such as management, rotation and manure which are not mentioned in Section 205.205. The NOSB drafted a comprehensive Organic Farm Plan document and a parallel Organic Handling Plan document which incorporated the statutory requirements the Proposed Rules glosses over.
Conversely, we believe that the Proposed Rules exceed the NOP's authority by requiring split operations submit information on the expected quantity and location of prohibited substances that they may use on the non-certified portion of their operation. The requirements of the Farm Plan pertain solely to the organic operation and what measures the producer will undertake to prevent contamination either from his own or another non-certified operation. It is excessive and burdensome to ask producers to include detailed descriptions of their non-certified operations in the Organic Plan.
The Secretary requests comment (Question #33) on the proposed scheme for making records available as well as the possible alternatives. We favor the scheme which provides the certifying agent the maximum amount of information regarding the operation prior to the site inspection. Generally, this would entail not only creating the necessary information but submitting it to the certifying agent in advance.
Section 205.214 Approval of certification
Since we have argued in our comments on Subpart B for a re-introduction of variances in the Final Rules, it is appropriate to address their effect on the certification process. The draft document authorized certifying agents to evaluate variances in the context of overall progress in an operation's organic management:
"An applicant for renewal of certification has implemented the provisions delineated in the organic plan, including measures to reduce or eliminate the use of any variance(s), or has identified appropriate measures in an amendment(s) to the organic plan to fulfill provisions of the organic plan."103
This language clearly identifies the relationship between documented practice and intent established in the organic plan as the fundamental criteria a certifying agent uses to measure performance. We recommend this section be added to the Final Rules.
Section 205.217 Continuation of certification
This section establishes procedures to provide operations a continuation of certification in lieu of an annual renewal. The approach outlined in the Proposed Rules requires each operation to "certify on an annual basis that it is producing agricultural products in compliance with the Act and regulations." The problem we see in this approach is that it changes the process of re-certification to one more closely resembling self-certification. The Department proposes to override the standard industry practice of requiring certification renewals without ever identifying the rationale behind its decision.104
Section 205.215 Denial of certification
Section 205.218 Notification of non-compliance with certification requirements
Section 205.219 Termination of certification
These sections contain an inherent weakness within Part D of the Proposed Rules: power to terminate certification is vested in the Administrator of the Agricultural Marketing Service rather than the certifying agent. Under provisions in these sections, the certifying agent is restricted to issuing a notification of non-compliance to the certified operation and recommending termination to the Administrator. The Administrator is responsible for issuing violation notices to the operation and making the final determination whether or not to terminate certification. Denying certifying agents the ability to terminate or even suspend an operation's certification will seriously compromise the ability of the NOP to function effectively. Leaving the decision in the hands of the Administrator invites a prolonged review and appeal process during which time suspect products would maintain certification and be marketed. We strongly recommend that certifying agents retain the authority to enforce NOP standards and suspend certification for an operation or part of an operation so that suspect products are not sold as organic. The Administrator would review the certifying agent's decision before making the final ruling on termination of certification for the Department. Under the OFPA's provisions, certifying agents are independent legal entities and are legally responsible for their actions.105 Clearly, Congress envisioned a system in which state and private certifying agents would have considerable authority over all certification decisions.
Subpart E
Accreditation of Certifying Agents
General comments
The primary role for the USDA within the NOP is accreditation. The Secretary is responsible for the evaluation of state and private certifying agents operating under the NOP. If these agents meet the requirements set forth in this subpart, the Secretary "accredits" them as agents acting on behalf of the USDA and empowers them to make certification decisions. The task of accreditation is essential for fulfilling the OFPA's core responsibility to assure consumers that organically produced products meet a consistent standard. The delegation of authority to field representatives to award or deny organic certification is the fundamental mechanism for making the NOP operational. The NOP should implement the accreditation process with a strong commitment to the public/private partnership model which inspired the OFPA. The percentage of currently operating certification agents which apply for NOP accreditation will be an important indicator of how well the Final Rules meet the needs of the organic community.
The statutory requirements of the OFPA dictate a unique approach to accreditation. Typically, accreditation and certification organizations are distinct and independent entities. 106 Accrediting organizations certify the certifying agents. Accrediting organizations establish baseline or minimum standards which certifying agents can meet or exceed as they choose but the agents always determine the specific provisions of their standards. The autonomy of the organizations created natural checks and balances; accrediters could decertify sloppy agents and agents could replace lax accrediters. Protecting the value of an organization's professional reputation (and the fees it could command) provided incentive to keep standards and accountability high. The OFPA diverges from the norm by delegating responsibility both to establish organic standards and determine which certifying agents are qualified to review certification applications to the NOP. The consolidation of so much authority in one agency is a powerful argument for making certain that the public interest is well represented and heeded within that agency. The Department must demonstrate a genuine commitment to incorporating private sector expertise into the accreditation process. Existing certifying agents represent a wealth of experience, credibility and manpower and will be essential partners for making the NOP functional.
Section 205.300 Areas of accreditation
This section correctly allows for accreditation in specific areas of expertise such as crops, livestock, wild crops or handling. Certification agents should have the option of specializing in categories or pursuing accreditation in all areas.
Section 205.301 General requirements for accreditation
Section 205.301 contains a long list of provisions which define the working relationship between the NOP and the certifying agents it accredits. This section addresses legal issues pertaining to the conduct of an inspector's job and the certifying agent's privileges and responsibilities as representatives of the NOP. The Proposed Rules are fundamentally satisfactory in this area and we specifically endorse the provisions in Section 205.301(10) for prevention of conflict of interest. The Organic Certifiers Caucus of the Organic Trade Association has also recognized the need to establish a policy to deter conflicts of interest from undermining the credibility of organic certification and such provisions belong in the Final Rules.
We believe that certain parts of Section 205.301 require revision. Several provisions could lead to an excessive degree of federal interference in the conduct of the certifying agent's affairs. For example Section 205.301(a)(5) states that accredited certifying agents shall "Conduct an annual performance review for each inspector used by the certifying agent and implement measures to correct any possible defects." Certifying agents should be allowed to continue establishing their own inspector evaluation practices without the NOP imposing requirements. Certifying agents will need to justify their inspector evaluation practices to the satisfaction of the USDA as part of their application for accreditation. Section 205.301(a)(15) requires certifying agents to "comply with and implement such other terms and conditions deemed necessary by the Secretary." We find this sweeping language too dismissive of the public/private partnership inherent in the NOP and recommend that any provision or policy which the Secretary deems necessary be addressed through the rulemaking process subject to public comment. We also object to Section 205.301(a)(12) which requires certifying agents to "charge only such fees to applicants for certification and operations it certifies that the Secretary determines are reasonable." There is no statutory authority in the OFPA for the Secretary to establish fees charged by certifying agents. The Proposed Rules must be amended to leave that responsibility with the state and private entities where it belongs.
Sections 205.301(b)(1) and (2) contain provisions affecting one of the most contentious issues addressed in the Proposed Rules: the authority of state and private certifying agents to use a seal, logo or other identifying mark to denote their work. The NOP, in accord with the position taken by the NOSB, hold that such state and private seals cannot, in the words found in the Proposed Rules, "require as a condition of use of its identifying mark compliance with any farming or handling requirements other than those provided for in the Act and the regulations in this part." We are in agreement with this provision because it accomplishes the OFPA's mandate "to insure consumers that organically produced products meet a consistent standard." We do wish to point out that this issue will become moot to the degree that the Department can bring the NOP standards into greater compliance with the norms of the organic industry. Existing certifying agents have felt pressured to retain their seals principally because of their general dissatisfaction with the Proposed Rules. We believe that the best resolution to this divisive issue is to create Final Rules which certifying agents would be comfortable adopting.
We strongly endorse the NOSB recommendation and the provisions in the Proposed Rules which allow for additional claims as long as they are made and verified separately from those claimed under an organic certification seal. From the standpoint of commercial free speech and the need to meet certain requirements which export markets may demand, certifying agents must be allowed to make and verify additional claims. Such claims might include "organic and grown without Chilean nitrate", "organic and local" and "organic and harvested by union workers."
The two provisions in Sections 205.301(c)(1) and (2) create legal and financial barriers which could inhibit good candidates from applying for NOP accreditation. Both provisions are contained in the OFPA and have a place in the Final Rules but are too ambiguous as currently proposed. Section (c)(1) transfers liability to the certifying agent in case it fails to carry out the provisions of the Act. While we do not question that certifying agents must be accountable for their actions, under the Proposed Rules they are also liable for actions of the Secretary. Without the independent authority to suspend certification, certifying agents are bound by whatever determination the Secretary reaches. If they are to be treated as independent and liable parties, certifying agents must be able to make suspension decisions independent of the Secretary.
Section (c)(2) requires that certifying agents furnish reasonable security to protect the rights of program participants yet there are no provisions to determine the amount required prior to notice of accreditation. Potential certifying agents would enter into the application process without knowing its full potential cost and cannot reasonably be expected to participate on those terms. We recommend that a formula to determine the amount of security required be established through an additional round of public comment. This recommendation is consistent with the Senate Committee report which directed the Department "to carefully construct a reasonable security deposit system that provides adequate protection for the Department while at the same time allows for a diversity of private groups in the certification business." 107 If left unchanged, the current provisions place significant constraints on state and private certifying agents and will at least discourage if not preclude many worthy candidates from applying.
Section 205.302 Applying for accreditation
Site evaluations are a well established and vital component of applying for accreditation. The accrediting agency must have the authority to visit and evaluate applicants in the same way that certifying agents need to inspect operations applying for certification. The Department acknowledged the importance of site visits by stating in the Supplementary Information that "such a process is necessary for the Secretary to maintain adequate oversight of the activities of accredited certifying agents under the Act." While the NOSB recommended that site visits precede the final decision on accreditation, we accept the provision in the Proposed Rules which would allow the NOP to delay the visit until after accreditation was awarded. This will certainly be necessary if a significant number of the more than 40 current certifying agents apply for accreditation and the Department wants to keep the program on the tight schedule it has projected. There simply would not be sufficient time to visit and evaluate the first round of accreditation applicants in the six months the Department has allotted. We believe it preferable for the Department to base its accreditation decisions on the written materials it receives rather than to further delay program implementation by waiting for the results from a site visit. A subsequent provision in Section 205.309 commits the NOP to making a site visit within a reasonable time after the approval of accreditation is awarded and we believe that this will adequately fulfill the purpose of the visit.
Section 205.304 Evidence of expertise and ability to be submitted by an accreditation applicant
While the provisions within this section are generally acceptable, they needlessly impinge on the responsibilities of certifying agents. Section 205.304(b)(5)(iv) establishes that certifying agents may only make public non-confidential business information as permitted by the producer or handler and approved by the Secretary. There is no need or justification for the Secretary to have any involvement in this process as consent of the producer or handler should be sufficient.
Section 205.309 Site evaluations
The Secretary requests comment (Question #34) on whether the proposal to conduct a site evaluation of an accreditation applicant at any time is appropriate. We believe that this is a valid and justifiable approach which is analogous to the certifying agent's ability to conduct spot compliance inspections on certified operations. We have argued repeatedly on behalf of transparency in the entire certification process and it behooves certifying agents to accept a high degree of scrutiny. We ask the Department to bear in mind, however, that the cost of site evaluations are charged to the certifying agent and that excessively frequent visits could be burdensome.
Section 205.311 Peer review panel
The Secretary requests comment (Question #35) on whether the peer review process for accreditation should occur when the initial application is made as opposed to when accreditation is confirmed after a site visit. We strongly believe that the peer review committee must be involved in the review process from the time the NOP receives an application, through the site visit and culminating in the final determination whether or not to award accreditation. There should also be a role for the peer review panel to convene to consider issues involving non-compliance of an accredited certifying agent. The statutory foundation for this recommendation rests on the provision in the OFPA that:
In determining whether to approve an application for accreditation submitted under section 6514 of this title, the Secretary shall consider a report concerning such applicant that shall be prepared by a peer review panel established under subsection (b) of this section. 108
The peer review panel must become involved during the initial review of an application for its report to be timely for the Secretary's decision on whether to award accreditation.
The Final Rules must include a fuller description of the make-up of peer review panels and their role in accreditation decisions. The peer review panels embody the public/private partnership needed to make the NOP work. They were designed to compensate for the lack of organic expertise inside the USDA and to reduce the need for bureaucracy by bringing in specialists from the private sector to perform essential functions. In this regard, their contribution will be comparable to the service which the NOSB provides. The original intent of Congress to maximize the involvement of private sector expertise on peer review panels is evident in the conference report language:
The Committee recommends that the Secretary utilize the expertise of individuals from existing certification organizations to assist him in the establishment of accreditation standards and in the evaluation of applicants...This concept of a peer review committee is based upon the university system where accreditation teams, consisting of persons from accredited universities, evaluate fellow universities for accreditation. 109
The Proposed Rules fail to address the OFPA provision that "not less than two members of such panel (which will contain not less than three members) shall be persons who are not employees of the Department of Agriculture or of the applicable state government." Section 305.311(b)(ii) states that "at least two members shall not be personnel of AMS or an approved State program." This does not insure, however, that the remaining panel members are not employees of another division of the Department. We recommend that the Final Rules incorporate the OFPA statutory requirement to include non-USDA representatives on peer review panels.
Section 205.311(b)(2) proposes that "Each convened peer review panel shall include no less than one member who possesses sufficient expertise...in the areas of accreditation delineated in the notice of approval of accreditation." We believe that these areas of accreditation should be delineated in the initial application because the peer review panels must meet, review and submit a report before the Secretary can issue a notice of approval. The Supplementary Information explains that this provision was included to respond to public comment that representatives of consumer, environmental and other public interest groups should serve on peer review panels. While the intention to include outside experts on the review panels is not unjustified, candidates who lack expertise in the specifics of certification and accreditation are by definition not suited to be peers. The peer review panels were created for the particular purpose of evaluating a candidate's capability to serve as a certifying agent and members much possess a strong working knowledge of organic production. We recommend a revision of this provision to incorporate the OFPA's requirement that each peer review panel members possess "expertise in organic farming and handling methods."
Subpart F
Additional Regulatory Functions
Fees
Section 205.421 Fees for accreditation applicants and agents
Section 205.422 Fees for certified operations
Section 205.423 Fees for import programs
Section 205.424 Payment of fees and other changes
The organic industry was built by small farmers and their nonprofit certification organizations. This point is highlighted in the Secretary's Small Farm Commission report which credits organic agriculture for the survival of many small farms: "Organic farming has given innovative small farmers an opportunity to enjoy price premiums in one of the fastest growing segments of the food industry."110 It is essential that the National Organic Program help the people who built this industry.
Data from the northeast region shows the extent to which small farmers are the foundation of this industry. Many of these farms gross less than $5,000 annually:
| State | farms <$5,000 | certified farms |
| CT | 25 | 47 |
| MA | 20 | 60 |
| ME | 80 | 170 |
| NJ | 23 | 56 |
| NY | 60 | 180 |
| RI | 19 | 28 |
| VT | 45 | 170 |
| TOTAL | 272 | 711 |
| source: The Natural Farmer, Spring 1988, Vol. 2, No. 36 | ||
We are deeply concerned that the proposed fees will price the small farmers, handlers and certification agents out of business. While these fees may not seem onerous compared to other USDA programs, unlike those other programs, the National Organic Program was established to help small and moderate-sized farmers. Under the Proposed Rules, all organic farmers grossing more than $5,000 annually must pay an annual fee of $50 to the USDA; handlers grossing more than $5,000 must pay an annual fee of $500. The Proposed Rules would charge all certification agents, regardless of size, an application fee, and administrative fee of $2,640 each year. At least once every five years, and possibly more often, the USDA would conduct a site visit to certifying agents which will cost each organization an estimated $3,500. Finally, certification agents will have to furnish "reasonable security", although no guidance is provided as to the meaning of reasonable.
We offer three recommendations designed to facilitate the participation of small farmers and certification agents. First, as stated earlier, we believe that truly small operators — those grossing less than $10,000 either as a handler or as a farmer — should be exempt from mandatory certification. Many operators this size are direct marketing their products and the fee and paperwork burden created by the National Organic Program is needlessly burdensome.
Second, all the fee schedules proposed under the National Organic Program should be based on a progressive basis rather than flat rates. This will mean that smaller operations will not bear a disproportionate financial burden. Furthermore, if minimum fees are set for certification for those farmers and handlers who qualify for the $10,000 exemption, many such operators may voluntarily choose to become certified.
Finally, we urge the Secretary to continue to support strong budgets for the National Organic Program. The OFPA does not require the Department to collect fees to cover all of its costs; it only requires that the Department "provide for the collection of reasonable fees from producers, certifying agents and handlers who participate in such program." In addition to fee setting authority, the OFPA includes a "sums as necessary" appropriation authority. Other program activities, such as the NOSB work, staff attendance at important organic agriculture meetings here and abroad and staff work to consult with federal and state partners should be paid out of appropriated funds. The Small Farm Commission Report encourages budget support:
Effective certifications and enforcement of the national standards will be critical to maintaining the integrity of organic products, consumer confidence in the organic label, and fair market access to what will continue to be an expanding market with the entrance of large food processing firms. Funding should be provided at $2 million per year for the National Organic Program to support the implementation and ongoing administration of the national standards.111
Compliance Review and Other Testing
Section 205.430 Compliance review
Residue testing
The Secretary requests comment (Question #37) on whether requiring residue testing of organic produce from certified operations not less frequently than every five years is appropriate. The Proposed Rules would require residue testing in excess of what the law requires, in excess of industry norms and in excess of NOSB recommendations. The Senate Report accompanying the OFPA stated that residue testing "is an important check on the honesty of the system" which certification agents use when necessary. 112 The Report identified a regular program of random screening and sampling in specific instances when contamination is suspected as appropriate applications for residue testing. Many state and private certifying agents currently require residue testing for sites where prior cropping systems increase the likelihood of finding persistent contaminants.113 Mandatory testing on a routine basis has never been a part of the organic certification process. Requiring 20% of all organic operations to undergo testing annually is an unnecessary and expensive burden on producers and certifying agents.
The NOSB recommended that residue testing take place closer to the point of purchase to monitor for contamination occurring after the food and fiber have left the farm. The NOSB derived its recommendation from dialogue between producers, handlers, certifying agents and consumers and its position is preferable for reducing costs and paperwork and building consumer confidence.
We strongly recommend that the Final Rules adopt the NOSB recommendation and establish uniform national URECs at five percent of the EPA tolerance or the actual FDA action level. Section 205.430(d)(2) identifies an unavoidable residual environmental contamination (UREC) level as a threshold beyond which produce produced on an organic operation may not be sold as organic. The purpose of this provision is to acknowledge that organic is not synonymous with pesticide free and that elements beyond the control of the producer such as from pesticide drift may leave residue traces on organic produce. This provision is consistent with existing state and private certification standards and serves to protect both producers and consumers. The NOSB recommended a standardized approach of establishing URECs at five percent of the EPA tolerance or the actual FDA action level for residues on food crops.114 However, the Proposed Rules allow the Secretary to establish URECs on a site specific basis and at levels which exceed five percent of the EPA tolerance or the actual FDA action level. The Department contends in the Supplementary Information that regional variation in URECs would make a national standard impractical. There are, however, countless situations where natural or manmade environmental conditions vary but are still effectively regulated by a single, consistent standard. Because of heightened concern over carcinogenic and endocrine disrupting pesticides, the Congress passed the Food Quality Protection Act in 1996 which will require the EPA to re-evaluate the more than 9,000 tolerances it currently enforces. Consumers of organic products expect and deserve a more uniform standard of protection than the Proposed Rules would allow.
Equivalency of Imported Organic Products 115
Section 205.482 Process for establishing equivalency
We are concerned that Section 205.482(c) does not provide for swift withdrawal of equivalency status if foreign programs are deemed inadequate. The "receipt of notice" provision should be strengthened to ensure that questionable products are quickly removed from commerce. Mail notification may be insufficient in that it may allow questionable products to linger on the market. We expect that this is a issue covered in other USDA programs and we suggest that the NOSB and the USDA evaluate various models of equivalency cancellation.
Section 205.484-205.999 (Reserved—fumigation)
Rules regarding the use of fumigation materials should be inserted here, including a list of acceptable fumigation materials that satisfy phytosanitary standards and the needs of organic integrity. The Proposed Rules are silent on the issue of fumigation of imports into the U.S. and fail to develop a U.S. position of the fumigation of U.S. exports sold in foreign markets. The NOSB has placed this topic on its July, 1998 meeting agenda. It is incumbent on the NOSB and the Secretary to determine a list of acceptable fumigation materials which satisfies phytosanitary standards at the same time as meeting the needs of organic integrity. More research should be undertaken to determine the suitability of controlled atmosphere containers as a substitute for fumigation.
Regulatory Impact Assessment for Proposed Rules
Implementing the Organic Foods Production Act of 1990
The USDA needs reliable information about the organic industry to provide optimal regulation, monitoring and facilitation of that industry. The Secretary requests data (Questions #38 - #41) to support the Department's decison making in several areas. Data essential to thoroughly and quantitatively describing the organic industry, analyzing the effects of the Proposed Rules on that industry, assessing comments on the Proposed Rules and reporting these effects to the public are not currently available.
This section of our comments responds to the ten areas of information requested by the Secretary to aid the Department in its regulatory assessment. Three questions guide the discussion for each of the ten areas of inquiry:
Areas of inquiry
The most comprehensive review of the number of organic producers in the market to date is in the USDA AMS publication Organic Food and Fiber: An Analysis of 1994 Certified Production in the United States.116 Organic vegetable growers were surveyed in the 1994 Vegetable Chemical Use Survey done by the USDA NASS in 14 major vegetable growing states. The most recent review of the number of farmers producing organically can be found in the 1997 publication Agrisystems International Reports Certified Organic Production in the United States: Half a Decade of Growth.117 Another source of information on the number of certified farmers is the annual organic farmers survey conducted by the the Organic Farming Research Foundation. Their most recent estimates show 4,638 certified organic farmers nationwide. However, this estimate excludes an unknown number of QAI certified producers and 286 known organic producers that did not respond. 118
Reliable national estimates of non-certified producers are not apparent. To understand the key reasons why we have weak information on how many non-certified organic farmers, wild crop harvesters and handlers are currently operating in the United States, see the 1998 report by the Organic Farming Research Foundation entitled Searching for the "O" Word, which documents the lack of public research devoted to organic agriculture. 119
Baseline information about the number of certified and non-certified farmers, wild crop harvesters, and handlers producing and marketing organic goods needs to be collected in a systematic and scientific manner in order to provide credible information to producers, input suppliers, processors, distributors, retailers, consumers and investors in the organic industry. Assembling this information will entail regular reporting and cooperation between the 44 (33 private and 11 state) certification organizations currently operating in the United States. Information on those operating without third party certification is obviously more difficult to track. No more than rough estimates of this group have been made. Ultimately, the best way to enumerate this group accurately is by encouraging and facilitating their certification.
The USDA is the proper entity to build and maintain a national program for tracking certified farmers, wild crop harvesters and handlers. Because the information has broad public uses and requires public confidence, an independent, unbiased government approach is necessary. An effort to cooperate with certifying organizations on an annual reporting system would be welcomed by many of the 44 certifying organizations currently operating in the United States. An estimate of the number of non-certified businesses is also required to fully characterize the organic sector. Encouraging and facilitating the certification of farmers, wild crop harvesters and handlers, an appropriate role of the USDA, will help accomplish this task. A regional pilot program may shed light on possible alternative strategies for accomplishing this goal.
To establish a baseline, the USDA requests data on the number of entities certifying organic farmers and handlers and the number of organic farmers who are currently accredited.
These data are available in the reports listed in 1A. For further information, the Organic Farming Research Foundation annual survey report should be consulted. 120
See response to 1.
See response to 1.
To establish a baseline, the USDA requests data to characterize the costs of organic production and the revenues from organic production.
For nearly two decades now, a growing number of American farmers have expressed interest in the economic performance characteristics of organic farming systems. Considerable work has been done in many states and regions. However, a comprehensive national characterization of costs and revenues for organic agricultural enterprises is not feasible at this time due to the lack of a systematic, centralized base of information.
An overview of the economic evaluation of alternative agricultural production is available in Part one, Chapter four of the 1989 National Research Council book entitled Alternative Agriculture.121 A summary of research on the costs and benefits of sustainable agricultural production is given in Chapter six of Planting the Future.122 A series of studies through the 1980s and 1990s are reviewed briefly on pages 94-96 of this volume. A selection of studies includes:
Batte, Marvin T. Sustainable agriculture and farm profitability: the case of organic farming in Ohio. Presented at American Agricultural Economics Association Annual Meeting, Baltimore, Maryland. 1992.
Cacek, Terry and Linda A. Langner. "The economic implications of organic farming." American Journal of Alternative Agriculture 1(1):25-29. 1986.
Dobbs, Thomas L. "Organic, conventional and reduced till farming systems profitability in the Northern Great Plains." Choices 9(2): 31-32. 1994.
Fox, Glenn, Alfons Weersink, Ghulam Sarwar, Scott Duff and Bill Deen. "Comparative economics of alternative agricultural production systems: a review." Northeastern Journal of Agricultural and Resource Economics 20(1):124-142. 1991.
Lockeretz, William, Georgia Shearer and Daniel H. Kohl. "Organic farming in the corn belt." Science 211(6):540-546. 1981.
A complete list of the reviewed studies is available on pages 94-96 of Planting the Future.
Newer studies on the costs of organic production and the revenues from organic farming have been completed since the Planting the Future volume was released in 1995. For example, the American Journal of Alternative Agriculture recently published "Organic versus conventional grain production in the mid-Atlantic: An economic and farming system overview."123 Still more studies can be found through a search of the National Agriculture Library's computer assisted database.
Despite all of this work, the fact remains that the vast majority of American farmers, agricultural researchers and administrators, and officials within state departments of agriculture continue to be unaware of, or simply reject on the basis of inadequate documentation, the notion that organic agriculture increasingly constitutes a profitable economic production alternative for an expanding set of producers. The expanding supply of organic foods in the U.S. marketplace attests to the fact that organic production is an economically competitive enterprise in many regions for domestic and foreign export markets.
It is critically important to build a credible, systematic national information base of the costs and benefits of organic production during this period of rapid market expansion. The information will help all participants in the organic sector, from farmers and ranchers to retail stores, to more efficiently serve the demands of domestic and foreign consumers. For example, this information will assist lenders in making adequate financing available to growing organic enterprises.
The Wallace Institute, in collaboration with the U.S. Department of Agriculture's Economic Research Service, the University of Georgia and the University of Massachusetts, is beginning a major research effort that will contribute to a better understanding of these issues on a national level. The first phase is a project entitled Market Development for Organic Agricultural Products: Implications for Domestic Markets, International Competitiveness, and Rural Communities funded by the Fund for Rural America for 1998-2000. This initial inquiry will gather and synthesize existing information to assemble the first national information base on the market supply and demand for U.S. organic agricultural products. It will also estimate major factors that influence the demand for selected organic products, and begin the analysis of organic market conduct, structure and efficiencies. Finally, the project team will evaluate the present international competitiveness of organic products and the potential effects on rural community enhancement of added organic production in a selected region.
A second phase to collect new primary data on the costs, supplies, revenues and demand for organic food products, and to analyze the effect of the proposed national organic rule on market supplies and demands will be submitted to the Fund for Rural America for funding in 1998. The Wallace Institute has also committed to conduct a study of the farm-level economic performance of organic grain and oilseed production in the Midwest. The information will be useful to Midwest farmers as they look for information about diversified production alternatives after the passage of the 1996 Federal Agricultural Improvement and Reform Act.
The USDA is the only organization that can ensure the systematic collection of credible national information on the costs and revenues of organic agriculture. It performs this public information role for other types of agricultural production, and logically should do so for organic agriculture. The Department may pursue this task by undertaking a national data collection initiative and/or coordinate numerous regional projects (such as the one being undertaken by the Wallace Institute for Midwest agriculture). The work could be undertaken in concert with the Fund for Rural America project led by the Economic Research Service and the Wallace Institute. The objective is to build upon the existing regional, state and local knowledge bases to develop a comprehensive national portrayal of the benefits and costs of organic production.
Much of this proposed USDA organic cost and revenue initiative can be pursued through expanding the scope of existing programs. For example, the USDA's National Agricultural Statistics Service (NASS) currently collects economic costs of production data for non-organic farms through its Agricultural Resources Management Survey. This survey does not collect sufficient information to characterize the costs of organic production because the sampling size is too small. The NASS should oversample organic farms to build a credible production information base. It can do so by assembling a comprehensive population of organic producers working in concert with organic certification entities. A second program that can be expanded to address the organic market is in the USDA's Agricultural Marketing Service. The AMS collects information on many different agricultural markets. However, it does not collect any market intelligence specific to the organic market. The AMS should institute a systematic market intelligence program to characterize the composition of and trends in the organic market. Finally, the USDA Foreign Agricultural Service can and should improve foreign organic market intelligence by increasing the coverage of and sophistication of its trade reconnaissance of organic goods.
To assess the impact of the proposed program, the USDA requests data on fees currently paid by organic producers and handlers for certification services and on fees currently paid by organic certifiers for accreditation.
These data are available in the reports listed in 1A. For further information, the Organic Farming Research Foundation annual survey report cited in endnote 5 should be consulted.
See response to 1.
See response to 1.
To assess the impacts of the proposed program and to better project costs of operating the National Organic Program (which will be covered by fees), the USDA requests information to project the number of organic producers and handlers who would apply for certification under the National Organic Program. The USDA also requests information to project the number of entities which would seek accreditation as an organic certifying agent.
Economic theory and empirical methods can be used to help project the numbers of producers and handlers who would apply for USDA organic certification as well as the number of entities which would seek accreditation as USDA organic certifying agents. To our knowledge, this theory and methods have not been applied to these issues yet. Developing such applications will be possible when a comprehensive information base is available. Only preliminary survey data are available to date. For example, an April mail-in ballot conducted by the Vermont NOFA showed that 61% of the respondents wanted the the existing federal organic law repealed.
A first step in understanding likely responses to the USDA program is to analyze the factors affecting producer and handler certification behavior under existing state programs. Initial information collection processes may begin with a survey of accreditation entities' population lists. Using information about the likely benefits and costs of applying for certification under those existing programs, theoretical models of the certification decision processes of producers and handlers can be developed. In turn, econometric models can be developed to test for the relative significance of different factors that influenced actual participation rates.
The findings from these initial analyses can then be used to develop models of certification behavior under the national USDA organic program. The models will have to be altered to add factors in the national program that are not present in the existing programs, and to drop factors that do not exist in the national program. The econometric approach is likely to take the form of a discrete choice model because the decision to certify is a "yes or no" question (will a given farmer/handler/certifier join the USDA program or not?). Given that data do not exist on actual participation in the USDA program as yet, simulation analyses will be required. An example of literature on a related process is available in the Rand Journal of Economics article Predicting Committee Behavior in Majority Role Voting Experiments 124. A different use of econometrics in understanding the likely number of organic producers who will apply for certification is to create a model that estimates the factors affecting the conversion from conventional to organic production using the ARMS data collected by the NASS or other information.
While the science exists to build a rigorous economic model to project the number of producers and handlers who will apply for certification under the USDA organic program and the number of entities which will seek USDA accreditation as organic certifying agents, the Wallace Institute also recommends that the USDA also explore the process of fostering increased rates of certification and accreditation. At the heart of this process is the "principal-agent" theory.
In this case, the principal is the USDA and the agents are the farmers, handlers and certifiers. The relationship between the principal and agent in this theory is created by a contract under which a person (the principal) engages another person (the agent) to perform some service on their behalf which involves delegating some decision making authority to the agent. The risks that the principal faces (moral hazard and adverse selection) are addressed by providing the proper incentives to the agents to act in the best interests of the principal. A general discussion of this conceptual approach and related issues can be found in the Rand Journal of Economics article Linear Probability Models of the Demands for Attributes with and Empirical Application to Estimating the Preference of Legislators. 125
The principal-agent theory, along with theories relating to the science and art of persuasion126 provide assistance in developing methods which will help insure maximum "buy-in" to the USDA organic program by producers, handlers and certifiers of organic goods.
The USDA can project the numbers of producers, handlers and certifying entities that will choose to be a part of the USDA Organic Program, and develop programs to foster increased rates of certification and accreditation through a five step process:
Conduct the theoretical and empirical research about certification and accreditation outlined above.
Develop an understanding of the theory behind persuading people to believe in the program and choosing to be a part of the program.
Work to establish cooperative partnerships with the farmers, handlers and certifying entities which the USDA needs in order for the National Organic Program to operate at an optimum level of performance. This would include the development of a comprehensive database that estimates the number of organic producers and handlers working with organic certification entities.
Implement programs designed to facilitate and encourage target populations to "buy-into" the National Organic Program.
Develop and implement a program to assure compliance with the law.
The regulatory impact assessment for the proposed rule considers that cost may be incurred by the fraudulent labeling of organic products. To what extent does mislabeling of non-organically produced products as organic occur and what are the market impacts in terms of quantities of organic goods sold and the prices for organic goods?
While there has been no systematic study of how fraud affects the organic industry, anecdotal evidence points to the conclusion that fraud is a major concern for the industry's proponents. Perhaps the most notable example of fraud in the organic goods industry is the case of Glacial Ridge Foods, a wholesale supplier in Starbuck, Minnesota. Glacial Ridge Foods, which was certified organic by the OCIA (the nation's largest organic certification organization) was found to have mislabeled and sold as organic over 600,000 pounds of beans. The Glacial Ridge Foods Case resulted in the sentencing of the president of the firm and the guilty plea of the principal of the firm. It also had further-reaching consequences including a damning fiscal report citing mismanagement of funds at the OCIA which led to the resignation of the OCIA's president and action on the part of the Minnesota Department of Agriculture to increase oversight of organic certification procedures. The Organic Trade Association and the organic industry as a whole applauded the state's efforts to ensure that products being sold as organic are indeed organic.
Fraud in the organic goods market may have a more serious effect on the organic market than other markets because organic products can not be distinguished from conventional products in the marketplace. Consumers depend entirely on certifiers to truthfully distinguish organic from non-organic goods. Moreover, the consumers' continuing demand for organic products depends fundamentally on protecting the integrity of the food products.
Measuring fraud in the organic market is difficult in part because there are 44 different organic certification entities in the United States. The creation of a national organic program could make some headway in easing the complexities of measuring and controlling mislabeling of organic products. However, this will not fully eradicate fraud, or solve the problem of estimating the likely amount of fraud in the organic market. In order to estimate and minimize fraud, a systematic nationwide system measuring fraud and its effects should be a part of the National Organic Program. Swift, strict and consistent punishment for those found to have committed fraud should be an integral part of the program. Other anti-fraud programs existing in government agencies as well as private industry should be consulted in developing this program.
Measuring the potential effects of fraud under the national program requires university and government research to understand the driving forces behind current fraudulent behavior in the organic industry. Case studies of the effects of fraud in the organic goods industry from around the nation should be developed. In addition, original consumer research on the effects of fraud in the organic goods market should be done. After these initial studies are complete, they should be used as the building blocks for more quantitative analytical work on this issue. Finally, a confidential survey of industry members performed by the USDA in collaboration with organizations like the Organic Trade Association and the Organic Farming Research Foundation may shed light on the current state of fraud in the organic industry.
The USDA is the proper place for much of the work related to fraud in the organic goods industry to take place. Developing a program to root out, estimate the effects of and minimize fraud may best start with a strategic analysis of the problem. The goal of the program is to minimize fraud given available resources. The strategies to do so include (1) accurately tracking and measuring fraud; (2) punishing those engaging in fraud; and (3) estimating the effects of fraud for purposes of reviewing the program's success or failure.
Performing strategy (1) will entail a review of anti-fraud programs currently operating in the United States which bear some similarity to the planned anti-fraud program for the National Organic Program. The business world should be visited for models (e.g., Aetna's Internal Audit Department) as well as other government agencies. In addition, there are several consulting firms which deal specifically with the development of anti-fraud programs for organizations (such as KPMG Peat Marwick, hich has developed a Control and Risk Assessment Program).
After initial research is complete, the process of developing an anti-fraud program should begin. This process will entail several steps including the development of:
The inclusion of all participants who have joined the National Organic Program in developing the USDA anti-fraud program is critical to the anti-fraud program's success. These individuals or their representatives should be invited to a meeting where timetables and test cases are decided upon. Effects of the USDA National Organic Program's anti-fraud program on the interest groups should be reviewed and discussed. Designated anti-fraud staff at each participating organization should be trained so that they completely understand the fraud program's processes and how the fraud program's goals fit into the overall goals of the entity and the USDA National Organic Program. The success of the USDA National Organic Program anti-fraud program is entirely dependent on the oversight of the process and the quality and quantity of resources assigned to the program.
Strategy (2) should grow directly from the planning processes developed in strategy (1). Strategy (3) will be best accomplished by outside research organizations with the capacity to develop sophisticated quantitative analysis of national data provided to them by the USDA regarding the anti-fraud program.
This rule would permit the marketing of meat and poultry products as organic, which is not currently permitted. The USDA requests data and analyses which would support projections of the demand for organic meat and poultry.
Findings from a national consumer survey show that a majority (51%) of all U.S. food shoppers say that an organic seal would make them more likely to purchase organic meat and poultry.127 This interest exists even among consumers who do not currently buy organic products. This supports our assumption that consumer interest in certified organic meat and poultry is widespread.
Some information useful in projecting the demand for organic meat and poultry is available in the 1996 USDA ERS report An Annotated Bibliography of Recent Elasticity and Flexibility Estimates for Meat and Livestock.128 This information may not be organic-specific, but it can help build a research methodology which will be of use in developing a study of the market demand for organic meat and poultry. Another study to consider for methodological purposes, but not specific to organics, is entitled Contingent Valuation of Consumers' Willingness to Purchase Pork with Low Saturated Fat. 129 The methodology of this study could assist in building a model to estimate consumers' demand for meat and livestock produced with organic methods.
The fact that there is a market for organic meat is clearly demonstrated in foreign markets. One of the most prominent of these is the European Community market. The EU has established a definition for organic livestock as well as standards for organic meat. They have in place a system of regular inspections through national certification entities.
The market in the United States is harder to measure or track because there are no standards or system of measurement in place at the present time. However, anecdotal evidence points to a healthy market for natural and organically-raised meat and poultry. There are many successful producers and marketers of natural and organically-raised meat. They exist in Colorado, California, Ohio, Iowa, Virginia, Texas, Pennsylvania and other states. The various marketing techniques and successes of these operations are outlined in a series of well-researched case studies in Alternative Agriculture.130 Another potentially useful case may be found in the experience of the Oregon cattle ranchers who have developed "Country Natural Beef", a product which has been successfully exported to some Pacific Rim countries.
Work to create accurate projections for the market for organic meat and poultry is necessary. While few studies have been done at this time, good models for the methodology needed to measure and forecast this market are available. Estimates of the public's willingness to pay for organic meat and poultry, and elasticity of demand estimates for organic meat and poultry are central components of a successful National Organic Program.
The various research programs of the USDA should devote more funds to projects related to organic meat and poultry, and to all organic foods. Out of the approximately 30,000 projects listed on the Current Research Information System database, only 34 projects (less than one-tenth of one percent) are strongly related to organic goods. Those 34 projects comprise approximately $10 million out of the total public agricultural research funding of $1.8 billion. Out of 159 projects funded by the Federal State Market Improvement Program's from 1985-1991, only six were directly pertinent to organic foods production and marketing. The SARE program, while not devoted to organic goods, has much information pertinent for organic farmers. However, this program remains underfunded and is a tiny fraction of the funding devoted to agriculture research. For more information and statistics related to the lack of resources devoted by the USDA's current agriculture research system to organic production and marketing, see Searching for the "O" Word, published by the Organic Farming Research Foundation 131
The regulatory impact assessment for this rule reports that sales of organic goods have been growing at an annual rate of 20%. Are there data to support a different rate?
The organic industry's main trade publication, the Natural Foods Merchandiser (NFM), reports that the market for organic food has been growing at a rate of 20% to 25%. The numbers provided to support this assessment are as follows:
| Organic Sales History | ||
| year | amount | annual change |
| 1980 | $178 million | |
| 1989 | $631 million | |
| 1990 | $1.00 billion | |
| 1991 | $1.25 billion | |
| 1992 | $1.54 billion | 23.0% |
| 1993 | $1.89 billion | 23.0% |
| 1994 | $2.31 billion | 22.2% |
| 1995 | $2.80 billion | 21.7% |
| 1996 | $3.50 billion | 26.5% |
Sales of organic products by category have also been measured by the Natural Foods Merchandiser.132 In 1996, sales of the following categories were listed as follows:
| Category | Sales in U.S. $ millions |
| grocery | $513 |
| frozen/refrigerated | $283 |
| bulk | $242 |
| herbs | $191 |
| dairy | $120 |
| bakery | $117 |
| produce | $89 |
| miscellaneous | $395 |
However, the Natural Foods Merchandiser has been tracking the organic market with rudimentary methods. They include direct measurements of only "self-described" natural and health food distributors in their market overview, omitting direct measurements of mass market distributors, who have become increasingly involved in the natural foods market since the late 1970's. The NFM is currently working to improve its data collection and analysis methods.133
The 20% growth figure which is so oft quoted is probably as good a rough estimate as exists. But it should not be taken as fact, since no direct measurement of a large segment of the market is being taken. More accurate measurements of the organic industry's growth may well be available from A.C. Neilsen/SPINS, Roper Starch and other private firms, but they have not been widely reported for public consumption perhaps because access to these data requires significant payments. Rapid growth in the organic market is all but impossible to deny. The market has attracted the attention of many investors and venture capitalists in the past few years and industry analysts predict it will continue to grow at a rate equal to or exceeding 20% to 25% each year for the next five to 10 years.134
We do not know enough about the organic market to know whether the absence of public institutions (market data collection and analysis) is hindering or distorting growth. There are virtually no systematic production or market survey data being collected with which to assess the rate and pattern of organic market growth. Such data are public goods that help markets perform efficiently and thus help maximize social welfare. The USDA and other public sector entities routinely provide market participants with similar data on conventionally-produced crops. It would be an appropriate role for them to do the same for organically-produced crops.
The Fund for Rural America project led by the USDA's Economic Research Service and the Wallace Institute will soon be starting the process of assembling a more comprehensive economic portrayal of the organic sector (as noted in request for information number three). In its first phase, the project will assemble existing information to assess the size and functioning of this growing market. The potential benefits that the market holds for consumers, producers and rural communities will also be addressed. In order to understand the long-term evolution of industry structure and growth, a long-term strategy must be developed.
The Economic Research Service has limited activities underway to build economic intelligence about the organic sector. However, much more data collection and analytical support from the USDA are necessary to provide timely and reliable public information to assure that this rapidly expanding market serves domestic consumers well and reaches its full export potential. As previously stated, the USDA should insert, where pertinent, questions about organic goods in existing surveys being done by the various Department agencies. At small or modest cost, surveys performed by the FAS, NASS and AMS can all be altered to greatly improve the information available about the rate of growth of the organic goods market.
We estimate that the organic industry may grow after program implementation due to the introduction of organic meat and poultry and increased exports of organic agricultural products. Are there data to estimate the impact that this rule is likely to have on overall industry growth?
Reliable quantitative studies of the possible effects that a National Organic Program may have on the organic market have not been done yet. General economic theory suggests that establishing national standards for organic goods and a system of mandatory certification and accreditation may enhance trade — as long as the United States standards meet the certification requirements of other countries in which organic goods are a growth sector. If this qualification is met, benefits will accrue to consumers in the form of greater confidence in the organic label, a wider selection of organic products and lower prices as markets expand and become more efficient. This conclusion implies that the proposed national rules are adjusted to accurately reflect the collective preferences of the organic industry and consumers' preferences for food quality and environmental attributes of organic products.
The Food Marketing Institute survey Shopping for Health suggests that such certification will enhance the likelihood that a majority of consumers will buy organic produce, meat and poultry, and processed foods. Producers will benefit from national organic standards through increased assurance in the quality of certification, protection from fraudulent labeling, access to international markets, organic meat and poultry labeling, and the economies of scale and production efficiencies which accompany market expansion. Certifiers will benefit from national organic standards through increased demands for their services as organic production increases, efficiency gains from information sharing, cost savings from a guarantee of reciprocity among accredited certifiers domestically, and access to international markets through country-to-country equivalency agreements.
Evaluation of the effects of the national organic standards for production and processing is critical to understanding the organic market and ensuring that it is operating efficiently (i.e., without market barriers acting as impediments to its growth). If funded, the second phase of the Fund for Rural America project, co-directed by the USDA's Economic Research Service and the Wallace Institute, will investigate and estimate the effect of the national organic standards on the market for organic goods. The first objective in phase two is to clearly articulate the economic understanding of the operation and interaction of process or product standards, certification and labeling and apply it to the market for organic products. Using rigorous economic analyses, the effects of standards, certification and labeling on organic markets will be explained and the implications for organic market development will be described. Both general efficiency effects and specific market effects of standards, certification and labeling will be examined. The issue of the efficacy of national standards will be addressed. For example, is information about process attributes such as organic production of sufficient importance to induce private and public activity as opposed to other product attributes?
The effects of the standards on domestic demand (e.g., changes in market structure, changes in price premium, attainment of economies of scale) will be analyzed, as will the effects on international competitiveness (regarding the competitiveness vis a vis other competitors). For example, the question of how U.S. exporters are positioned to enter and compete in foreign markets will be explored. Effects of the national standards on rural community enhancement will also be addressed in this project. The second objective of phase two is to develop a working, applied model of the economic reasoning behind the application of the standards, certification and labeling of organic goods. The purpose of the model will be to generate testable hypotheses to be used in analyzing markets for organic products.
The USDA is the logical leader in efforts to estimate the effect of the national organic standards on the long-run growth of the organic industry. To fulfill its leadership responsibilities, the USDA should take at least the following steps:
The organic industry and consumers of organic goods may benefit if industry growth results in economies of scale, and production and marketing efficiencies. What has been the industry experience in this area and do industry participants anticipate such benefits from this rule?
Adequate organic market performance data are not available. Anecdotal evidence from numerous organic entities strongly suggest that producer price premiums over conventional products are falling, that marketing channels are becoming more numerous and efficient, ranging from local farm markets to mainstream retailers, and that retail price spread between organic products and conventional food products are falling. Still, there is a lack of hard evidence to quantify the extent and pace of change.
Two types of work need to be undertaken to estimate the effects on production costs and consumer prices from growth in the organic foods industry. First, national surveys of organic producers should be undertaken to estimate the behavior of production costs for different sizes and types of organic production. Because comprehensive data has not been collected in the past, the temporal pattern of cost changes can not be estimated. It may be possible to infer this pattern of change by examining the experience of organic production in European countries where the sector has expanded faster. A thumb rule in other industries is that costs of production fall by at least 10% with every doubling of industry production. However, this rate of decline depends fundamentally on the amount and nature of research that supports production and marketing improvements. The second area of investigation covers the improved efficiency (cost per unit of product delivered) of processing and marketing as organic food products expand. This area of study may be more challenging as private firms are less likely to provide the proprietary data about their operations which would reveal their trends in costs and prices. A critical area of investigation as the organic industry expands is the potential for excessive concentration in production, processing, distribution or retailing to diminish industry and consumer benefits due to a lack of effective competition. Adequate diversity is essential to maintaining competitive prices and for stimulating innovations throughout the production to retail marketing chain.
The USDA is the logical leader of the investigation into production and market efficiencies that result from growth in the organic industry. Major roles within the USDA should be held by the ERS, NASS, AMS and FAS. The Agricultural Research Service (which can foster new production systems), and SARE (which can develop cutting-edge systems on the ground) should each hold an important place in the investigation as well. The Cooperative Business Development Program offers important opportunities to foster growth as well. Many farmers and processors are small and may view cooperatives as viable mechanisms to bring supplies together to attain greater production and processing efficiencies. The agency also must partner with non-governmental organizations such as the OFRF and OTA and leaders in the private for-profit sector to ensure a successful program with quality data. Finally, the Fund for Rural America should serve as a support mechanism to foster this work given its three interwoven goals of improving and enhancing competitiveness, environmental quality, and rural development.
Appendix A
Comments on the Paperwork Reduction Act
Submission of comments on the Paperwork Reduction Act discussion in the Supplementary Information was requested by January 16, 1998. At the January 15-16, 1998 National Campaign for Sustainable Agriculture Subcommittee meeting on organic agriculture, the following letter was composed and submitted to the Docket. Among the signatories is Wallace Institute Senior Analyst Kathleen Merrigan. We resubmit this letter as Wallace Institute comment on this portion of the Proposed Rules.
This letter cites the need for more time for proper data collection and analysis. To the extent that such data exists, it has been analyzed in our earlier discussions in the section on fees and the in regulatory impact assessment.
In the rush to meet this early deadline, one mistake was made in the letter. Under duration of Recordkeeping, we fail to recognize that the OFPA requires farms to maintain records for five years. While this may be unnecessarily long, we understand the statutory imperative. This is even more reason for the Secretary to develop two categories of records; in this way the statute can be adhered to without overburdening farmers.
January 16, 1998
Lisa Grove, Desk Officer
Office of Management and Budget
New Executive Office Building
725 17th Street, N.W., Room 725
Washington, D.C. 20503
Don Hulcher, Clearance Officer
USDA-OICO
Room 404W, Jamie Whitten Building
Ag Stop 7602, P.O. Box 96456
Washington, D.C. 20090-6456
Dear Ms. Grove and Mr. Hulcher:
We are submitting this letter in response to your request for comment on the Paperwork Reduction Act section of the proposed organic rule published in the Federal Register (Vol. 62, No. 241, December 16, 1997). The deadline for comment on this section is today, and while we are submitting this response in accordance with your timetable we would like to stress the need to discuss further these issues within the context of the full proposed rule for three reasons. First, much of this section relies on industry-wide estimates. Such a short comment period punctuated by holiday and vacation schedules has not allow an adequate opportunity for industry representatives to meet and jointly evaluate your analysis. Second, we are not yet fully prepared to address your data and questions in great depth. The proposed rule differs dramatically from the recommendations of the National Organic Standards Board (NOSB) so much of it requires new analysis. As well, the very length of the proposal, its complexity and the numerous open-ended questions makes it difficult to provide comprehensive discussion of all aspects of this section. Finally, we expect the overwhelming public response to the proposal will indicate a need for fundamental changes and these changes will likely necessitate recalculations and further discussion under the Paperwork Reduction Act.
Nevertheless, our preliminary review has identified the following concerns for your consideration.
(1) Duration of Recordkeeping
Recordkeeping is essential to the integrity of the organic system. The proposed rule would require certified farms, wild crop harvesting, and handling operations to maintain records for five years and certifying agents to maintain records for 10 years. Without accompanying rationale, the time period for producers seems arbitrary and unnecessarily long; the 10 period for certification agents is dictated by law. Three purposes of recordkeeping seem relevant to this section. First, recordkeeping is critical to tracing food and fiber products back to the source, if necessary. Since some processed food has long shelf lives, this purpose could be achieved if records were held for not less than three years. Second, recordkeeping may contribute to our understanding of potential environmental degradation if such investigations are necessary. Finally, recordkeeping provides information on the performance of certifying agents for the purpose of USDA accreditation.
We recommend that the Office of Management and Budget and the U.S. Department of Agriculture consult further with the organic industry, certifiers, environmental, and consumer groups to develop two categories of recordkeeping — fundamental records that must be kept for the duration proposed herein and supplementary records that must be kept for lesser periods of time. Because the USDA has limited experience with organic agriculture, we believe the paperwork involved in documenting organic compliance is drastically underestimated. Maintaining all compliance documents would be excessive and a great burden to this emerging industry.
(2) Exemptions from Certification
Several exemptions from certification are proposed. The exemption from certification of farm operations that gross under $5,000 annually is consistent with the law. However, we believe that such operations should be required to keep production practice records in addition to sales records for a one year period. Also, wild crop harvesting operations are not explicitly exempted in this section and we would expect the $5,000 gross sales exemption would apply similarly to these operations. The proposed threshold for exemption for handlers is also proposed as $5,000 gross sales. As this exemption does not appear in the law, a discussion of its purpose and the choice of $5,000 should be submitted to the public. Is the purpose to exempt small handlers? If so, does the $5,000 threshold capture the concept of small handler as well as it does for farming and wild harvesting operations? We require additional time for a full analysis of this threshold. Finally, we are unable to comment on your proposed exemption for handlers of multi-ingredient products. After much discussion, we find ourselves with multiple and conflicting interpretations of what this exemption is meant to encompass.
(3) Other Information Collection Requirements
We will be commenting on the inadequacy of the proposed rule as it relates to conflict of interest and audit trail provisions. The NOSB has made recommendations in these areas which we support but which do not appear in the proposed rule. If the NOSB recommendations are adhered to, it will place additional and significant paperwork burdens on producers, handlers, and certification agents. However, this additional paperwork is essential to the integrity of the organic certification system.
(4) The "Extensive Research" of the USDA
It is extremely important to stress that the statement that "USDA conducted extensive research while developing this proposed regulation" is a grand exaggeration. This section merely cites two minor studies as a basis for its analysis and, taken together with the small number of references listed at the end of the proposed rule, it illustrates the paucity of data on the organic agriculture sector and the consumers who support and purchase organic products. Yet this very limited data is used to justify certain certification schemes and fee structures.
We cannot emphasize too strongly the need for more and better data. The historic lack of USDA interest in organic agriculture has meant that agencies such as the Economic Research Service have not devoted the time and resources on organic as they have to other sectors. This lack of USDA assistance to the organic sector was recently documented in a report released by the Organic Farming Research Foundation which found that less than one tenth of one percent of USDA research dollars are spent on research directly pertinent to organic farmers. For this reason, we recommend, consistent with the NOSB, that the USDA absorb the costs of this program in its first year so that adequate data can be collected. Without this data, projections in this section are without foundation.
There are some obvious problems with the data presented that merit immediate attention:
(5) Residue Testing
The proposed rule would require residue testing in excess of what is required by law, in excess of industry norms, and in excess of NOSB recommendations. As the Congress stated in the report accompanying the Organic Foods Production Act residue testing is "a check on the honesty of the system" which is used by certification agents when necessary. Requiring 20 percent of all organic operations to undergo residue testing annually would be an unnecessary burden on farmers and certifiers. The NOSB recommended that residue testing should be closer to the point of purchase because oftentimes contamination occurs after the food and fiber products have left the farm. Adherence to the NOSB recommendations, which generated much discussion among and input from industry, consumer, and environmental groups would be preferable from a paperwork reduction and consumer confidence perspective. Also, no guidelines have been developed to guide certification agents as to what kinds of residue testing is expected and we expect that many inspectors will have to be trained in the latest technologies to comply with this requirement. We are preparing more extensive comments on this topic to be submitted later in the comment period.
(6) Electronic Data Collection
A significant number of farmers and certification agents are storing and communicating information electronically and we expect this trend to continue. However, we would oppose requiring electronic forms of communication at this time. Many of our organizations are non-profit and expensive technology purchases may not be possible at this time.
We hope these comments begin to answer the four questions you pose in this section. Thank you for the opportunity to comment.
Sincerely,
Kathleen Merrigan, Henry A. Wallace Institute for Alternative Agriculture and NOSB member
Fred Kirschenmann, Kirschenmann Family Farms and NOSB member
Joan Dye Gussow, professor emeritus and NOSB member
Betsy Lydon, Mothers & Others for a Livable Planet and NOSB member
Michael Sligh, Rural Advancement Fund International and former NOSB member
Nancy Taylor, Idaho farmer and former NOSB member
Katherine DiMatteo, Organic Trade Association
Brian Baker, Organic Material Review Institute and NOSB technical advisor
Melanie Adcock, Humane Society of the United States
Roger Blobaum, Organic Watch
Cecilia Bowman, Hoosier Organic Marketing Education
Paul Clarke, Greenpeace International
Ken Commins, International Organic Accreditation Service
David Engel, Organic Crop Improvement Association of Wisconsin
Judith Gillan, New England Small Farm Institute
Elizabeth Henderson, New York Sustainable Agriculture Working Group
Liana Hoodes, New England Sustainable Agriculture Working Group
Patricia Kane, Northeast Organic Farming Association of New York
Joseph Mendelson, Center for Technology Assessment
Tony Kleese, Organic Trade Association's Organic Certifers Council
Mark Lipson, Organic Farming Research Foundation
Margaret Mellon, Union of Concerned Scientists
Anne Mendenhall, Demeter Association
Marty Mesh, Florida Certified Organic Growers and Consumers, Inc.
Emily Brown Rosen, Northeast Organic Farming Association of New Jersey
Tim Sullivan, Minneapolis Minnesota attorney
Enid Wonnacott, Northeast Organic Farming Association of Vermont
Appendix B
Legal Memorandum on the Role of the
National Organic Standards Board
On March 31, 1998 the following document, with an accompanying letter signed by the NOSB, was sent to Secretary Glickman and the Docket. The Wallace Institute prepared this legal memorandum on behalf of the NOSB. On March 31, 1998 NOSB Vice Chairperson Kathleen Merrigan sent a letter to Secretary Glickman requesting a meeting on behalf of the NOSB to discuss the Board's ongoing role in the National Organic Program. A meeting has yet to be scheduled.
View the letter to Secretary Glickman, and the Legal Memorandum on the Role of the National Organic Standards Board
Endnotes
| 1. | NOSB, Definition of Organic, April, 1995. |
| 2. | NOSB, Definitions and Interpretations, November 1, 1995. |
| 3. | The variance concept contained in Section 205.4 of the Department's June draft document and deleted from the Proposed Rules applies to this discussion. The June draft document proposes that certain restricted practices be allowed as "variances" from standard allowed practices under specific conditions. While introducing the new terminology of variances is somewhat confusing, given the historical use of approved and restricted practices in organic certification, the underlying concept is nevertheless consistent with current state and private certification programs. |
| 4. | These are the requirements for certifying agents set forth in Section 205.4(b) of the Department's June draft. |
| 5. | NOSB annotations are listed and this issue is discussed further in our discussion of Section 205.20. In some limited cases, variations of the NOSB recommended annotations are included as variances in the June draft document. Whether included in the Final Rules as "annotations", "variances" or "restrictions", the Secretary should adhere to the NOSB dictates on National List material use. |
| 6. | This example comes from the NOSB recommendations on definitions. |
| 7. | A typical manual example would be "Fresh Cranberries, Shipping Point and Market Inspection Instruction", June, 1996. This manual was developed by the Secretary for use by the inspectors of fresh cranberries. |
| 8. | See for example, the Tennessee January, 1988 Field Office Technical Guides on Waste Management System; Waste Treatment Lagoon; Waste Storage Facility; Fence; and Agrichemical Handling Facility. |
| 9. | Crop rotations are among the most researched and best understood practices associated with organic agriculture. Improved soil structure, enhanced fertility and suppression of pest and disease pressure have been consistently associated with their use. The Report and Recommendations on Organic Farming (USDA, 1980); Alternative Agriculture (National Academy Press, 1989) and Organic Farming (Farming Press, 1990) by Nicholas Lampkin provide comprehensive documentation on rotation benefits. Building Soils For Better Crops (University of Nebraska Press, 1992) by Fred Magdoff provides specific insight on integrating crop rotations with sustainable, low input systems. |
| 10. | The June draft document requires that at least one soil-improving crop (such as sod, legumes or green manures) be in a crop rotation. This approach is very appealling. |
| 11. | Wang G., T. Zhao, and M.P. Doyle. 1996. Fate of Enterohemorrhagic Escherichia Coli 0157:H7 in Bovine Feces. Appli. Environ. Microbiol. 62:2567-2570. |
| 12. | Actually, some certification programs have, for years, used a 120-day standard for leafy greens, root crops, and green onions since these crops seem particularly susceptible to contamination. |
| 13. | April 13, 1998 Federal Register (63 FR 18029). Comments on these guidelines may be submitted to the Docket until June 29, 1998. |
| 14. | Martin, Deborah and Grace Gershuny. eds. The Rodale Book of Composting. Rodale Press, 1992. This publication provides an excellent overview for home and small scale composting efforts. Chapter 4 "Management of Manure, Slurry and Residues" in Lampkin's Organic Farming and trade publications such as BioCycle present thorough evaluations of the practices required in effective commercial scale composting. |
| 15. | The description of compost presented here is consistent with the position taken by the NOSB at its March, 1998 Ontario, California meeting. |
| 16. | The 1998 Northeast Organic Farming Association-NJ and Maine Organic Farmers and Gardeners Association standards contain good examples of such prohibitions. |
| 17. | The series "Fear in the Fields" from the Seattle Times on July 3 and 4, 1997 details the practice of manufacturing industries legally disposing of hazardous waste by marketing it as fertilizer. Many state and federal regulations do not take into consideration the hazardous materials which can co-exist with desirable nutrients in fertilizers generated from industrial processes. We feel it appropriate for the NOP to take a clear stand prohibiting categories of industrial waste which have no role in organic production. |
| 18. | The Proposed Rules refer to genetically engineered organisms as do we in our discussion. Some people prefer the term genetically modified organisms (GMOs); we regard the two terms as synonymous. Throughout this document we use the term genetically engineered organisms and the acronym GEOs to include genetically engineered and modified organisms and the products of genetic engineering, including transgenic crops. |
| 19. | Recently published research on transference of genes linked to enhanced cold tolerance is one example of a potentially beneficial GEO application. Reported in "Arabidopsis CBF 1 Overexpression Induces COR Genes and Enhances Freezing Tolerance." Science, 280(5360), April 3, 1998. |
| 20. | The Supplementary Information would seem to support such a policy: "Our requirements address the systems used to produce an agricultural product rather than the physical qualities of the product itself." p. 65869. |
| 21. | The OFPA defines synthetic as "a substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plant, animal or mineral sources, except that term shall not apply to substances created by naturally occurring biological processes." The organic community as well as the scientific panels convened by USDA have consistently classified all GEOs and transgenic crops to be synthetically produced. Categorizing all GEOs as synthetic materials is a reasonable and desirable approach and is consistent with the historical as well as legal definition of the term synthetic under OFPA. |
| 22. | See letter from the NOSB to Secretary Glickman from March 25, 1998 and the attached legal memorandum supporting NOSB authority in the listing procedure, Appendix B. |
| 23. | The seven criteria in the OFPA are: the potential for harmful interaction with other materials used in organic farming; the toxicity, mode of action and persistence of the material and its breakdown products; the probability of environmental contamination during manufacture, use, misuse and disposal of the material; effects on human health; effects on other organisms in the ecosystem; the availability of alternatives; and compatibility with a system of sustainable agriculture. |
| 24. | The position of the NOSB on GEOs has been widely misunderstood because a single resolution has been taken out of context. At the April, 1995 meeting of the NOSB, the Board passed a "resolution" to the Secretary which said, in essence, that genetic engineering was incompatible with organic production. The NOSB passed this resolution because the public input sessions of the Board and the correspondence received by NOSB members was almost entirely on the issue of GEOs. As such, it was becoming increasingly difficult for the NOSB to conduct work in any other area as it was asked to rehash the GEO issue again and again. While the NOSB understood that it would continue to be responsible for reviewing GEOs as petitioned, it wanted to provide the Secretary, the affected companies, and the public a sense of its current views on the subject. At that same meeting, the NOSB reiterated that its position on GEOs, as well as on all other materials, would be reconsidered five years from the point of the NOP implementation. Additionally, the NOSB stressed the need to develop criteria to assess GEOs once it had completed its recommendations to the Secretary necessary for the Proposed Rules. |
| 25. | Of the 35 GEOs approved for commercial use by 1997, 10 involved transferring resistance to pesticides including bromoxynil, glyphosate and glufosinate into corn, cotton and canola. See The Gene Exchange, published by the Union of Concerned Scientists, Fall, 1997. Also, many researchers are raising concerns that EPA mandated resistance management plans are inadequate to prevent the rapid loss of Bt as an effective pest control strategy for organic and conventional farmers alike. See the work of Fred Gould and Bruce Tabashnik in Now or Never: Serious New Plans to Save a Natural Pest Control. Union of Concerned Scientists, Cambridge, Massachusetts, 1998. |
| 26. | See Jorgensen, R.B. and B. Anderson "Spontaneous hybridization between oilseed rape (Brassica napus) and weedy B. campestris: A risk of growing genetically modified oilseed rape." American Journal of Botany 82:1620-1626, 1994 for discussion of gene transfer to weedy relatives. See literature in previous footnote for discussion on accelerated pest resistance. A London Times article on October 22, 1997 reported findings from the Scottish Crop Research Institute that female ladybugs that ate aphids fed on genetically modified potatoes laid fewer eggs. A more widespread case of unintentional side effects in engineered species is the unexpected boll deformation and early drop in 30,000 acres of Bollguard cotton in Mississippi in the summer of 1997. See The Gene Exchange, Fall, 1997. |
| 27. | The most recent Codex draft guidelines state that "All materials and/or products produced from genetically modified organisms are not compatible with the principles of organic production (either the growing, manufacturing or processing) and therefore are not accepted under these guidelines." The same draft defines GEOs as "all materials produced through the modern methods of biotechnology; specifically gene technology, 'recombinant DNA(rDNA)' and all other techniques using molecular and/or cell-biology for altering the genetic make-up of living organisms in ways or with results which do not occur in nature or through traditional breeding." From "Draft Guidelines for the Production, Processing, Labeling and Marketing of Organically Produced Foods," Codex Alimentarius Commission, Addenda 10, 1997. |
| 28. | See Docket comments submitted by the IFOAM. |
| 29. | No individual or organization testifying at the four USDA public listening sessions, the Vermont Natural Organic Farming Association winter meeting (at which the USDA took official comment), or the NOSB public input session in Ontario, California, supported the inclusion of GEOs in organic production at this time. Furthermore, our initial and therefore incomplete review of the Docket suggests that the vast majority of the 150,000+ comments ask that GEOs be prohibited in organic production. |
| 30. | See Organic Fiber Council Position Paper on the Proposed Rule, February 20, 1998. |
| 31. | The Department's June draft document required producers to address source and quality concerns for their irrigation water in their organic plan. We recommend reinsertion of this section. |
| 32. | Cech, Richard. "The Herbalists' United Plant Savers." Herbalgram 41, Fall, 1997. |
| 33. | Certified Organic Production in the United States: Half a Decade of Growth. AgriSystems International, Wind Gap, Pennsylvania, 1997. p. 23. Dairy cattle receiving certified organic care increased from 2,265 head in 1992 to 6,100 head in 1994 with the strong regional growth in New England, the Upper Midwest and the Rocky Mountain states. |
| 34. | The International Federation of Organic Agriculture Movements (IFOAM) has established the most widely recognized guidelines for accreditation of individual certification agents. The IFOAM essentially certifies the certifier around the globe and effectively establishes the parameters on acceptable practices. For a description of the minimum requirements expected of individual certification standards, see Basic Standards for Organic Agriculture and Processing. IFOAM, 1996. |
| 35. | Sir Albert Howard. An Agricultural Testament. p. 4. |
| 36. | Certified Organic Production in the United States. Agrisystems International, 1997. This market analysis indicated that the domestic supply of organic grain and pasture land has consistently expanded to supply market demand. Both the acreage and the knowledge needed to expand production are available. The Organic Trade Association has also expressed its belief that existing marketing structures are adequate to meet the anticipated needs for organic feed. |
| 37. | Regulating Pesticides in Food: The Delaney Paradox. National Academy Press, Washington, D.C., 1987. See Chapter 3, "Estimates of Dietary Oncogenic Risks." This study and the subsequent report, Pesticides in the Diets of Infants and Children (National Academy Press, 1993) provide detailed analysis of pesticide residues in fresh and processed foods as well as the relative oncogenic risks they pose. The 1987 study identified feed residues from the pesticide Linuron as the single greatest source of oncogenic risk in beef and pork. |
| 38. | NOSB Livestock Feed Standard, adopted June 2, 1994. |
| 39. | "Bovine Spongiform Encephalopathy: "Mad Cow Disease," Topics in Food, Science and Nutrition, July, 1996. p. 208-210. This article documents the findings of the United Kingdom Department of Health Spongiform Encephalopathy Advisory Committee in March, 1996 which identified the incorporation of rendered animals in the livestock feed supply as the "most likely" source of an increased incidence of spongiform encephalopathy in humans. This Advisory Report led the U.K. and the entire European Union except Denmark to ban the use of all mammalian meat and bone meal in ruminant feed. |
| 40. | Coleman Natural Beef, for example, has sold over 225 million pounds of beef (or one billion servings) in the last 10 years. This is a clear market for a beef product raised from birth without the use of hormones or antibiotics. Source: Docket comments submitted by Lee Arst, President of Coleman Natural Productions, Inc. |
| 41. | A wide variety of literature documents the routine presence of antibiotic and medicinal residues in meat and dairy products. "Chemical Residues in U.S. Meat and Poultry: Suggestions for Improvement in the USDA/FSIS Population Sampling Programs" (Dairy, Food and Environmental Sanitation 16(4):222-226) and "Human Health Risks Associated with Drug Residues in Animal-Derived Foods" (by Sundlof and Cooper in Veterinary Drug Residues) address this occurrence. In fact, permissible residue levels called food tolerances are established by the FDA for all livestock antibiotics and medicines. "Resistance Development Potential of Antibiotic/Antimicrobial Residue Levels Designated as 'Safe Levels'" (Journal of Food Protection 56(3):229-233) is one study which evaluates the potential for antibiotic residues to promote resistance in microbial populations. |
| 42. | NOSB, Final Board Recommendation on Organic Livestock Healthcare, Record-Keeping, Transportation Practices, clarified and adopted March, 1998. |
| 43. | Food, Agriculture, Conservation, and Trade Act of 1990 Conference Report 101-916. 101 |
| 44. | The NOSB's Progress Report on the Proposed National List (July, 1995) provides an analysis of the Board's exhaustive effort to create a flexible materials review policy which respects organic integrity. At the March, 1998 meeting in Ontario, California, the NOSB reaffirmed its support for the materials review process followed during 1994 and 1995 by the NOSB which led to the recommended list of materials submitted to the Secretary. As well, the NOSB appointed an ad hoc subcommittee to begin the process of drafting underlying principles to guide future material review in organic handling. We urge the Secretary to work closely with the NOSB as such drafts develop. |
| 45. | We recognize that, in the future, there may be reason to delineate a specific list of non-agricultural substances for use in organic products; currently Section 205.26 does not contain a specific list but allows all non-agricultural materials to be used. |
| 46. | "No form of chemical solvent extraction from raw material is acceptable to be labeled as organic." From Organic Trade Association Manufacturing and Processing Standards, adopted 1992. |
| 47. | NOSB Final Recommendation Addendum Number 12, "Allowable Methods of Oil Extraction for Processed Foods," adopted October 31, 1995. |
| 48. | Refer to Progress Report on the Proposed National List cited above. |
| 49. | We do, however, support the NOSB recommendation to allow sulfur dioxide for use in wine making, with certain restrictions. |
| 50. | Papazzian, Ruth, "Sulfites: Safe for Most, Dangerous for Some," FDA Consumer Magazine, December, 1996. |
| 51. | Code of Federal Regulations, Title 21, Part 170.3(o) lists ingredients and 21 CFR, Part 101.100(a)(3) describes incidental additives. The FDA exempts from food labeling requirements incidental food additives that are present in food in insignificant levels and which do not have any technical or functional effect in that food. |
| 52. | The NOSB further explains the meaning of incidental food additives in its October, 1995 Final Recommendation Addendum Number 15: "Such incidental food additives include: 1) substances that are incorporated into the food as a result of being an ingredient of another food (Example: An ingredient in pasta sauce is diced tomatoes that contain citric acid for pH control. Citric acid must be listed as an ingredient in the diced tomatoes. But the pasta sauce label does not have to list citric acid as an ingredient unless additional citric acid is added during processing of the pasta sauce.); and 2) processing aids that: i) are added to the food during processing but are removed from the food before packaging; ii) are added to the food during processing, are converted to constituents normally present in the food, and do not significantly increase the amount of these constituents normally found in the food; and iii) are added to the food for their technical or functional effect during processing but are present at insignificant levels in the final product and have no technical or functional effect in the final product." |
| 53. | As well, part of the confusion may stem from the fact that some materials which are considered incidental additives, such as citric acid, are included on the National List. But this is because such materials also appear as additive ingredients. Items which do not appear as ingredients, such as defoaming agents, are not separately listed. |
| 54. | At several meetings, the issue of microwave ovens has come up in discussions of food irradiation: Would, for example, a ban on irradiation prohibit microwaving food at the mini-restaurants now in many natural food retail outlets? The answer is no. The frequency spectrum of microwaves used in microwave ovens is in the non-ionizing range of electromagnetic radiation. |
| 55. | While we are aware that a number of published studies have identified potential adverse effects in laboratory animals fed diets containing irradiated food, there is an ample body of data to support the safety of ionizing radiation for food sanitation purposes. The absence of long-term studies on human subjects inevitably raises questions about the health effects of irradiated food and will lead many individuals to take a precautionary approach and avoid eating them. Consumers International cites an additional concern pertinent to the introduction of any new technology: "It is one thing to show that carefully monitored doses under lab conditions have no deleterious effects. It may be a different matter altogether where large quantities of food are treated in commercial plants and dosage levels are much more difficult to control." Consumers International, 1997. Food Irradiation: Solution or Threat?. In 1983, R.L. Hall of McCormick & Company stated in a petition to the FDA that "In existing large scale irradiators, it is quite likely that an overdose of 250% can be expected." Cited in Food Irradiation: Who Wants It? by Tony Webb, Tim Lang and Kathleen Tucker (Thorsons Publishers, 1987). |
| 56. | Congress designated ionizing radiation as a food additive under the Food, Drug and Cosmetic Act of 1958 (21 U.S.C. 348(f)). Some opponents of irradiation have criticized the FDA for not requiring human toxicity studies but such studies are not required because irradiation is a food additive not a process. |
| 57. | "The Secretary may not include exemptions for the use of specific synthetic substances in the National List other than those exemptions contained in the Proposed National List or Proposed amendments to the National List." OFPA, National List, 6517(d)(1). |
| 58. | Cited in Ionizing Radiation in the USDA/NOP Proposed Rule, published by the Organic Materials Review Institute, Eugene, Oregon, 1998. See the OMRI's comments for additional discussion of the technical aspects of ionizing radiation. |
| 59. | "The Food Zappers," Popular Science 244(1):72-77 & 86. January 1994. |
| 60. | For a thorough discussion of alternatives, see Food Irradiation: Who Wants It?. |
| 61. | FDA press release announcing approval of ionizing radiation for use on beef products, December 12, 1997. |
| 62. | "Kessler endorses consolidation of disparate food safety efforts." BNA Daily Report for Executives, April 8,1998. p. A16. |
| 63. | Personal communication with Jeff Voltz, Board Member, Frontier Cooperative, April 16, 1998. |
| 64. | The majority of 150,000+ comments submitted to the Docket identify food irradiation as unacceptable and request that the Secretary prohibit its use in organic food production. |
| 65. | Kolata, Gina, "Long quest for safer food revisits radiation method." New York Times, December 4, 1997. p. 1. |
| 66. | Skerrett, P.J. "Food Irradiation: Will It Keep the Doctor Away?" Technology Review, November-December, 1997. |
| 67. | For a full discussion of the nutritional and health problems associated with food irradiation, see Food Irradiation: Who Wants It?. |
| 68. | A recent study by the American Dietetic Association projected the cost of irradiation at two to three cents per pound for fruits and vegetables and three to five cents in meat. Bennett, Olivia and Christine Bruhn, ADA Position Paper on Food Irradiation, 1996. |
| 69. | Cesium 137 may become the preferred option because the gamma rays it produces are able to irradiate entire pallets of food. With cobalt 60, packages of food must be individually radiated which necessitates the unloading and reloading of every pallet. Many industry experts point to the extra labor associated with cobalt 60 as a significant factor limiting adoption of irradiation in the current market place. Skerrett, P.J., "Food Irradiation: Will It Keep the Doctor Away?" |
| 70. | Beyond the very frightening worst case scenarios, the normal functioning of our nuclear infrastructure may pose unanticipated risks. A 1991 study in the Journal of the American Medical Association documented a significant increase in leukemia - a known consequence of ionizing radiation - for workers at Oak Ridge National Laboratory. These workers experienced chronic low level exposure, not isolated doses in excess of "safe" levels. The researchers noted a latency period of up to 35 years in some subjects. Wing, S., Shy., Wood, J. et al. "Mortality among workers at Oak Ridge National Laboratory: Evidence of radiation effects in follow-up through 1984." Journal of the American Medical Association 265(11):1397-1402. |
| 71. | Irradiation was prohibited in the Department's June Draft Document. We recommend reinsertion of that prohibition as originally developed. |
| 72. | April 2, 1991 letter to Harold Ricker signed by Fred Kirschenmann and John Matthews. |
| 73. | For a sampling of farmer experience with Bt resistance, see Organic Gardening, January, 1996. |
| 74. | The NASS reports that Bt was used on: 29% of acreage devoted to fresh snap beans; 14% of broccoli acreage; 64% of fresh cabbage acreage; 61% of fresh celery acreage; 48% of eggplant acreage; 37% of bell pepper acreage; 21% of spinach acreage; 39% of fresh tomato acreage; 33% of strawberry acreage and 49% of raspberry acreage. For additional information, see "Comments on Plant Pesticide Resistance Management" to EPA Docket OPP-00470, submitted March 20, 1997 by Kathleen Merrigan. |
| 75. | In particular, see "White Paper on Bt Plant-pesticide Resistance Management," January 14, 1998 by the Environmental Protection Agency. See also the proceedings from the USDA National Forum on Insect Resistance to Bt, April 15-16, 1997. |
| 76. | , Standards for the use or disposal of sewer sludge. Title 40 CFR, Parts 257, 403 and 503, U.S. EPA, 1993 |
| 77. | Harrison, Ellen, Murry McBride and David Bouldin. The Case for Caution, Cornell Waste Management Institute Working Paper, August, 1997. p. 4. |
| 78. | Bouldin, D.R. "Why guidelines for beneficial use of sludges are different and estimates of alternatives." Soil Science Society of North Carolina Proceedings. The author concluded that with a loading of approximately one tenth of the zinc standard in Part 503, yield reductions of 10% are likely in 10% of the soil-crop combinations in the U.S. EPA database. These conclusions are supported by McGrath, S.P., A.M. Chaudri, and K.E. Giller, "Long-term effects of metals in sewage sludge on soils, microorganisms and plants." J. of Ind. Microb. 14:94-104. It is worth noting that the risk of pathogens is of such sufficient concern for Denmark and Sweden that they have prohibited application of sludges of any kind to lands used for grazing. |
| 79. | The Case For Caution p. 30. |
| 80. | For example, EQ sludge is allowed to contain 39 parts per million (ppm) cadmium, 17 ppm mercury and 420 ppm nickel. Comparable values in Germany are 10 ppm, 8 ppm and 200 ppm and in the Netherlands 1.25 ppm, 3 ppm and 30 ppm. The EQ standard for lead is 300 ppm though the acceptable ceiling under Part 503 is 840 ppm. Germany allows 900 ppm of lead and the Netherlands 100 ppm. It should be noted that the German and Dutch standards only apply to conventional agriculture because biosolids are prohibited in organic agriculture. The Case for Caution, p. 11. |
| 81. | From the Executive Summary of Use of Reclaimed Water and Sludge in Food Crop Production. National Academy Press. National Research Council. 1996. |
| 82. | Currently, 14,000 publicaly owned waste water treatment plants produce 5.3 million metric tons of dry sludge of which 36% is land applied, 38% is landfilled, 16% is incinerated and the balance disposed of in other ways. After the EPA prohibited ocean dumping of organic solids from wastewater treatment facilities, the industry sought out new disposal options. Utilities and public authorities are increasingly looking at biosolids as the most cost effective disposal option for their organic wastes. (NRC, Use of Reclaimed Water and Sludge in Food Crop Production). The additional expense of storage, composting and shipping biosolids is more than recaptured through avoiding the tip fee or capital cost of a modern disposal facility. For example, the Massachusetts Water Recovery Authority produces biosolids at a cost of $550 to $760 per ton which are primarily given away free to citrus growers in Florida and Texas. ("Bay state ships out its waste problems; destination often poor rural towns." Boston Globe, February 16, 1994). New York City has a similar arrangement through which it contracts for train loads of its sludge to be land applied in Texas while Los Angeles sends it biosolids to Yuma, Arizona. The enormous volume of biosolid production has outstripped the potential for organic agriculture to serve as a significant market. Using the EPA's maximum allowable per acre application rate, the Environmental Working Group estimates that certified organic acreage in the United States can only absorb 4/10 of 1% of current annual biosolid production. Source: Personal communication, Ken Cook, April 17, 1998. |
| 83. | The original Senate bill proposed a blanket exemption for synthetic inert ingredients while the House bill proposed their complete prohibition. The Conference Report substitute stated that "the category of synthetic inert ingredients not of toxicological concern to the Administrator of the EPA (are) possible exemptions on the National List." Conference Report 101-916. p.1179. |
| 84. | The NOSB, "Handling of Inerts Policy at April Meeting," April 11, 1995. |
| 85. | Personal Communication, Katherine DiMatteo, Executive Director of the Organic Trade Asssociation. April 1, 1998. |
| 86. | Generic Materials List: Interim Version for Advisory Council Review. OMRI, 1997. |
| 87. | "There's Big Green in Organic Food," Business Week, October 6, 1997. |
| 88. | Shopping for Health 1977, Food Marketing Institute. Washington, D.C., 1997. p. 31 |
| 89. | Trends in the United States: Consumer Attitudes and the Supermarket, Food Marketing Institute. Washington, D.C., 1997. p. 18. |
| 90. | The list provided in the Supplementary Information includes: "produced without synthetic pesticides", "produced without synthetic fertilizers", "raised without synthetic chemicals", "pesticide-free farm", "no drugs or growth hormones used", "raised without antibiotics", "no growth stimulants administered", "ecologically produced", "sustainably harvested" and "humanely raised." Considering the broad range of labels listed, it is reasonable to suppose that the entire class of ecolabels is open for discussion under this section. Other examples could include, "IPM", "sulfite free", "produced for the chemically sensitive", "produced using best management practices" and countless others. Nor is there any discussion of existing international labels that may be exported into the United States, such as the Environmental Choice label in Canada, the Ecomark label in India and Korea, and the Blue Angel label in Germany to name a few. |
| 91. | The FTC Guide was published in 1992. Between 1990 and 1996, the FTC investigated and won 32 environmental claim cases. Most involved single trait claims but some were system claims. Erickson, Audrae and Carol S. Kramer-LeBlanc "Ecolabels: the Link Between Environmental Preferences and Green Practices?" Strategy and Policy in the Food System: Emerging Issues, 1997. |
| 92. | Organic Food Production Act, 2106(1)(B) Compliance Requirements. Health and Human Services' jurisdiction derives from its responsibility for the Food and Drug Administration which was given broad food labeling responsibilities under the Federal Food, Drug and Cosmetics Act. |
| 93. | Committee members were concerned that the label claim "pesticide free" implied that no pesticide residues at all were present on a product. This was problematic because companies making that claim only tested for certain pesticides and only at certain levels. |
| 94. | Ecolabel claims will only grow in popularity; one study suggests that a majority of American consumers are willing to buy environmentally friendly products, and that 23% are eager to buy green. (The Hartman Report: Food and the Environment, a Consumer's Perspective, 1996). But these are emerging issues, and the Secretary should seek additional information before acting. The Secretary is likely aware of the work of the Environmental Protection Agency on ecolabeling and we recommend joint discussions. (U.S. Environmental Protection Agency, 1994. Determinants of Effectiveness for Environmental Certification and Labeling Programs. Office of Pollution Prevention and Toxics, EPA 742-R-94-001, Washington, D.C.) Also ERS has an ongoing cooperative research project to examine economic issues involved in using ecolabling as the link between consumer's market choices and producers' adoption of certifiably sustainable practices. |
| 95. | See the Textile Fiber Products Identification Act, 15, USC 70, and the Wool Products Labeling Act, 15, USC 68. |
| 96. | In creating categories for food handlers, the NOSB identified thirteen distinct categories: brokers, commission merchants, distributors, food services, jobbers, packers, receivers, repackers, shippers, processors, co-processors, truckers and warehousers. NOSB Final Recommendation, Requirements for Handler Certification, Attachment 1, adopted June 4, 1994 in Santa Fe, New Mexico. |
| 97. | The NOSB stated "The activity of individuals or businesses who do not take legal title to organic products but act as agents, licensees, employees, contractors, or subcontractors and who process, package, or store organic agricultural products for a certified handling operation will be covered by the certification of that organic handling operation. Such activity must be described in the Organic Handling Plan and inspected and scrutinized with the same rigor and to the same standards as certified entities as part of the certification requirement of the certified organic handling operation for which they act as agent, licensee, employee, contractor, or subcontractor." NOSB Final Recommendation, Requirements for Handler Certification, Attachment 1, adopted June 4, 1994. |
| 98. | While our earlier comments suggested modifications in the allowable language for products "made with certain organic ingredients," we support placement of the organic claim on the principal display panel. |
| 99. | The USDA cites figures in the Supplementary Information which peg 1990 sales of organic food at $1 billion and 1996 sales at $3.5 billion. |
| 100. | Figure calculated using the Consumer Price Index 1990-1998. Bureau of Labor Statistics, United States Department of Labor. |
| 101. | The Northeast Interstate Organic Certification Committee estimated that of the 711 organic farms certified in Maine, New Jersey, Vermont, Rhode Island, Connecticut and New York, 272 would be exempted under the $5,000 standard. Thus, more than one third of those currently supporting the cost of certification would be exempt from the new program. "The National Organic Program," The Natural Farmer, Spring, 1998. p. 21. It is noteworthy that small farms, including those with sales below $5,000, are currently willing to pay for certification because they enjoy a sliding fee scale and significantly lower overall fees than proposed by the Secretary. |
| 102. | The Department proposed this approach in Section 205.203(g) of the June draft document which stated that applicants for certification must "apply for renewal of certification annually, as provided for in Section 205.217, and provide such other information about the certified operation requested by the certifying agency to determine compliance with the Act and the regulations in this part." |
| 103. | June Draft Document, National Organic Program, Section 205.14(b)(5). |
| 104. | The Supplementary Information states that "Although nearly all the existing certification programs we reviewed require an annual renewal of certification, we are proposing in Section 205.217 that a certified operation needs to submit only updated information to the certifying agency on an annual basis. As proposed here, an approved certification status would continue in effect until the operation voluntarily ceased to be certified or was terminated, as proposed in Section 205.219." |
| 105. | The OFPA, Requirements of Certifying Agents, Section 6515(e), all certifying agents "agree to hold the Secretary harmless for any failure on the part of the certifying agent to carry out the provisions of this chapter." |
| 106. | For example, the International Standards Organization Guide 61 Requirements Section 2.1.2(o) states that (The accreditation body)...shall not offer or provide directly or indirectly those services that it accredits others to perform. |
| 107. | U.S. Senate Committee on Agriculture, Nutrition, and Forestry. Report on the Food, Agriculture, Conservation, And Trade Act of 1990. Report 101-357, June 6, 1990. p. 295. |
| 108. | The OFPA, Section 6516(a), Peer Review of Certifying Agents. |
| 109. | U.S. Senate Committee on Agriculture, Nutrition, and Forestry. Report on the Food, Agriculture, Conservation, And Trade Act of 1990. Report 101-357, June 6, 1990. p. 294. |
| 110. | A Time to Act: A Report of the USDA National Commission on Small Farms, USDA, January 1998, p. 107. |
| 111. | A Time to Act: A Report of the USDA National Commission on Small Farms, USDA, January 1998, p. 107. |
| 112. | U.S. Senate Committee on Agriculture, Nutrition, and Forestry. Report on the Food, Agriculture, Conservation, And Trade Act of 1990. Report 101-357, June 6, 1990. p. 300. |
| 113. | For example, NOFA NJ may require soil and tissue testing on fields which were once orchards or where potatoes were grown because these crops are associated with lead arsenate, mercurials and chlorinated hydrocarbon compounds. (NOFA NJ 1998 Certification Standards and Procedures. p. 3-4.) |
| 114. | The EPA establishes acceptable residue levels called tolerances for every pesticide on every food crop for which it is registered. The FDA establishes action levels for persistent pesticides which are no longer registered but which are still found in the environment. Any food which exceeds the EPA tolerance level or the FDA action level or which contains residues of pesticide not registered for that crop cannot be sold. |
| 115. | For general information on equivalency issues, we recommend the Guide to Regulatory Requirements for Exporting Organic Foods into International Markets, by Suzanne Vaupal and Ken Commins, November, 1997. This report was prepared for the International Organic Accreditation Service and the Third World Working Group of the IFOAM. |
| 116. | Dunn, Julie Anton. Organic Food and Fiber: An Analysis of Certified Production in the United States. U.S. Department of Agriculture. Agricultural Marketing Service, 1995. |
| 117. | Dunn, Julie Anton. Agrisystems International Reports Certified Organic Production in the United States: Half A Decade of Growth. Agrisystems International, 1997. |
| 118. | Walz, Erica. Personal communication. Santa Cruz, California: Organic Farming Research Foundation, April 29, 1998. See also Walz, Erica. 1995 National Organic Farmers Survey. Santa Cruz, California: Organic Farming Research Foundation, 1996. |
| 119. | Lipson, Mark. Searching for the "O" Word.Organic Farming Research Foundation, 1998. |
| 120. | Walz, Erica. National Organic Farmers Survey. Santa Cruz, California: Organic Farming Research Foundation, annual publication. |
| 121. | Pesek, John, ed. Alternative Agriculture. National Research Council, 1995. |
| 122. | Bird, Elizabeth R., Gordon L. Bultena and John C. Gardner. Planting the Future: Developing an Agriculture that Sustains Land and Community. Center for Rural Affairs, 1995. |
| 123. | Hanson, James, Erik Lichtenberg and Steven Peters. "Organic versus conventional grain production in the mid-Atlantic: An economic and farming system overview." American Journal of Alternative Agriculture 12(1):2-9, 1997. |
| 124. | Salant, Stephen W. and Eban Goodstein. Predicting Committee Behavior in Majority Rule Voting Experiments. Rand Journal of Economics, 1990. |
| 125. | Heckman, James J. and James M. Snyder. Linear Probability Models of the Demand for Attributes with an Empirical Application to Estimating the Preference of Legislators. Rand Journal of Economics, 1997. |
| 126. | Cialdini, Robert B. Influence: The Psychology of Persuasion. Quill Publishers, 1993. |
| 127. | "Shopping for Health." Food Marketing Institute, 1997. p. 31. |
| 128. | Hahn, William. An Annotated Bibliography of Recent Elasticity and Flexibility Estimates for Meat and Livestock. USDA Economic Research Service, Commercial Agriculture Division. Staff paper: AGES-9611, 1996. |
| 129. | Halbrendt, Catherine, Lesa Sterling, Sue Snyder and Gail Santoro. Contingent Valuation of Consumers' Willingness to Purchase Pork with Low Saturated Fat. Regional Research Project NE-165: Private Strategies, Public Policies, and Food System Performance, University of Massachusetts at Amherst, Department of Resource Economics, 1995. |
| 130. | Pesek, John, ed. Alternative Agriculture. National Research Council, 1995. |
| 131. | Lipson, Mark. Searching for the "O" Word. Organic Farming Research Foundation, 1998. |
| 132. | Scott, Mary. "Organic Sales Still Boom as New Challenges Surface," Natural Foods Merchandiser, 1997. |
| 133. | "Bringing Market Overview to the Next Level," Natural Foods Merchandiser, June, 1997. |
| 134. | "There's Big Green in Organic Food," Business Week, October 6, 1997. |
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