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Specific Comments 1-25 - Organic Trade Association
Organic Trade Association
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Specific Comments 1-25

 

SPECIFIC COMMENTS

of the

ORGANIC TRADE ASSOCIATION

to

7 CFR Part 205  [Docket Number: TMD-00-02-PR2]

RIN: 0581-AA40

National Organic Program; Proposed Rule

 

 

Despite major improvements in the Proposed Rule, the Organic Trade Association has identified a number of issues of concern, where changes are needed to create a National Organic Program which meets the needs and expectations of organic farmers and consumers.  Among them are the following:

 

Subpart A - Definitions

 

1. 205.2 Terms defined.

 

Agricultural product. Amend the definition to read:

 

Agricultural product. Any agricultural commodity or product, whether raw or processed, including any commodity or product derived from livestock that is marketed in the United States for human or livestock use or consumption.”

Rationale: The term “agricultural product” speaks only of products marketed for “human or livestock consumption.”  This inadvertently omits fiber crop products from the definition. The OTA believes that insertion of the word “use” is needed to broaden the definition. The OTA notes that “fiber” is included in the definition of “livestock.” Fiber should not be excluded by omission from the definition of “agricultural product.”

2. 205.2 Terms defined.

 

Animal drug. Replace the term “animal” with the term “livestock,” and use the term “livestock” consistently throughout the rule. “Livestock” is defined in the Proposed rule and in the Organic Foods Production Act of 1990 (OFPA), whereas the term “animal” is not defined. OTA supports the definition of “livestock” as proposed.

 

 

 

3. 205.2 Terms defined.

 

Insert as a new definition:

 

Annotation. Notes accompanying methods and substances allowed for use in organic production and handling which are required conditions for the specific use and application of such methods and substances.” 

 

Rationale: Annotations, or restrictions, are set for many of the items on the “National List of Allowed and Prohibited Substances.” By defining the term “annotation,” the concept is introduced early in the rule, and the term follows a standardized meaning when used throughout. If the term “annotation” is not defined, then the term “restriction” should be defined, using the same definition proposed above. It will be important that one of the terms be defined, as further details are developed in program manuals, and certifying agents measure compliance to the rule and adherence with all restrictions contained therein.

 

4. 205.2 Terms defined.

 

Insert as a new definition:


Apiculture. The care and management of bees and the harvesting of bee products.”

 

Rationale: As stated above, OTA supports the definition of “livestock” as proposed, which removes bees and aquatic animals from consideration as livestock. All livestock standards in the rule do not apply directly to bees or aquatic animals. In order for bees and aquatic animals to be regulated under this rule, they need to be defined, however. OTA proposes that apiculture be defined and regulated in this rule, since many certifying agents, and some States, already have established apiculture standards and certification protocols. In addition, a market already exists for organic apiculture products. OTA is not proposing a definition for “aquaculture” at this time, and does not support the inclusion of aquaculture standards in this rule. Organic aquaculture is in the very earliest stages of development. Very few certifying agents have developed organic aquaculture standards; there is very little experience with the certification of aquaculture systems; and the market for “organic aquaculture” products is controversial, at best.

 

5. 205.2 Terms defined.

 

Insert as a new definition:

Biological diversity. The existence of complex ecological systems as indicated by the presence of varied species of plants, animals, and other organisms such as are found in natural systems.”  (AOS 4.21)

Rationale: The term “biological diversity” is used in the definition of “crop rotation” in the proposed rule. OTA believes that it is important to define “biological diversity,” as the term will likely have further use in program manuals and certifying agent compliance assessment procedures.

 

6. 205.2 Terms defined.

 

Insert as a new definition:

Certificate (organic). An annual written assurance which identifies the name and address of the entity certified, effective date of certification, annual certification renewal date, types of products and/or processes certified, and name, address, and telephone number of the certifying agent.” 

 

Rationale: The term “certificate” is used in 205.404(b) without being defined. The definition proposed above, taken from OTA’s American Organic Standards (AOS), has the broad support of organic certifying agents in the United States. AOS was developed from existing private, State, and international standards. They were compiled through two rounds of extensive public comments, and were ratified by the OTA Board in October, 1999.

 

7. 205.2 Terms defined.

 

Commercially available. Replace “form, quality, or quantity” with “form, quality, quantity, or variety”.

 

Rationale: OTA supports inclusion of a definition of “commercially available.” The concept is widely applied, understood, and accepted in the organic industry. The definition should be amended to include consideration for “variety.” It is important for organic farmers that the variety of plant or animal, for which they have established a market, be commercially available.

 

8. 205.2 Terms defined.

 

Compost. The current definition needs to end after the first sentence, or else the following definition should be substituted:

 
Compost. The product of a carefully managed process through which microorganisms break down plant and animal materials into forms suitable for application to the soil. Materials added to the composting process are limited to those permitted for crop production by these standards, and do not include sewage sludge, biosolids or mixed municipal solid waste. Compost used in an organic operation must be managed appropriately for the duration necessary to effectively stabilize nutrients and kill pathogens.”

Rationale: It is unrealistic and inappropriate to link the definition of “compost” to NRCS practice standard 317, as stated in the proposed rule. The NRCS standard repeatedly refers to compost “facilities,” whereas much of the composting which occurs on organic farms occurs out of doors. The practice standard also mandates high temperature composting, which would inadvertently prohibit vermicomposting. In addition, the practice standard appears to be written for large-scale operations which must meet the standard in order to qualify for NRCS payments. It is inappropriate and unreasonable to require all organic operations to comply with the NRCS standard. The substitute definition proposed above merges fundamental concepts from the proposed rule, the NOSB (National Organic Standards Board) recommendation, and AOS in an attempt to provide a definition of compost which is clear, yet flexible.

 

9. 205.2 Terms defined.

 

Insert as a new definition:

Contamination. The introduction of prohibited substances to organic products, ingredients, production areas, handling processes, or to the environment.” 

 

Rationale: The term “contamination” is used five times in the proposed rule, yet the term itself is not defined. The above definition is taken from AOS, and is widely understood and supported by the organic industry.

 

10. 205.2 Terms defined.

 

Insert as a new definition:

Contract (certification). A written agreement between a certifying agent and a certified operator which states the duration of the agreement and all specifications for certification as determined by the certifying agent and agreed to by the operator.” 

 

Rationale: The existence of bona fide contracts between certifying agents and certified operators is essential to clearly define licensing agreements, seal use restrictions, and other specifications agreed to by both parties. In order for certification contracts to be recognized under this rule, the above definition, taken from AOS, should be inserted.

 

11. 205.2 Terms defined.

 

Excluded methods. The definition of the new term “excluded methods” should be amended to read:

 

Excluded methods (genetically engineered/modified organisms). Organisms, and the products and derivatives thereof, made with techniques that alter the molecular or cell biology of an organism by means that are not possible under natural conditions or processes, the use of which is prohibited under the Act and regulations in this part. Excluded methods include recombinant DNA, cell fusion, micro- and macro- encapsulation, gene deletion and doubling, introducing a foreign gene, and changing the positions of genes. Somatic cell cloning is also an excluded method. Excluded methods shall not include traditional breeding, conjugation, fermentation, hybridization, in-vitro fertilization, and tissue culture.”

Rationale: Genetically Engineered/Manipulated Organisms (GEO/GMOs) are defined by a new term “excluded methods.”  “Excluded methods” needs to be redefined to be consistent with the NOSB recommendation (Indianapolis, Sept., 1996, Sligh, p. 207). It also needs to include language to cover products and derivatives of GMOs, and include a clear prohibition on the use of excluded methods. The definition as proposed above accomplishes these objectives.

The NOSB defined GMOs as:

 

“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, 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, or tissue culture.”

 

Codex Alimentarius adopted a very similar definition for “genetically engineered/modified organisms:”

 

“Genetically engineered/modified organisms, and products thereof, are produced through techniques in which the genetic material has been altered in a way that does not occur by mating and/or natural recombination. Techniques of genetic engineering/modification include, but are not limited to: recombinant DNA, cell fusion, micro and macro injection, encapsulation, gene deletion and doubling. Genetically engineered organisms will not include organisms resulting from techniques such as conjugation, transduction and hybridization” (Codex Alimentarius CAC/GL 32-1999).

 

As noted in the preamble, the USDA received extensive public comment, with the single greatest response addressing the issue of GMOs in organic food. The comments, including those previously submitted by OTA, overwhelmingly support the categorical prohibition of GMOs.

 

The new term, “excluded methods,” raises several questions not addressed in the preamble or the rule itself. OTA questions why the USDA did not use the term genetically engineered/modified organism in this proposed rule when it specifically requested comments on that term in the previous proposed rule? The terms GEO and GMO are widely and commonly used in existing certification and accreditation programs. The term “excluded methods” is confusing and the change in terminology unnecessarily complicates implementation of the policy stated in the preamble.

 

Why does the proposed rule’s definition delete some examples from the NOSB definition and not others? The USDA stated that their scientists considered these examples redundant. The remaining examples  “recombinant DNA, cell fusion, and micro- and macro-encapsulation” serve to demonstrate the range of techniques that are “not possible under natural conditions or processes and are not considered compatible with organic production.” The term “recombinant DNA” refers to a DNA molecule containing segments from different sources using various techniques. The deleted terms “gene doubling and deletion, insertion of a foreign gene, and the changing of the position of genes,” in OTA’s opinion, help clarify some of the techniques used in forming recombinant DNA and do not detract from this definition.

 

On the other hand, “traditional” breeding techniques may rely on induced mutagenesis that results in gene doubling, deletion, or rearrangment through non-rDNA techniques (gene “jumping”). OTA has proposed wording to clarify these distinctions. OTA supports the use of the clarifying word ‘traditional’ in the phrase “Such methods would not include the use of traditional breeding” as a useful addition to the original NOSB definition.  This may provide guidance when a technique is evaluated for compatibility with organic systems.

 

OTA proposes that another option to accomplish a clear prohibition on GMOs would be to classify “excluded methods” as synthetic, and then to state that “excluded methods” are prohibited in the list of criteria used to evaluate materials for inclusion on the National List.

 

If the final rule considers GMOs synthetic, then NOSB and its Technical Advisory Panel (TAP) would need to review and recommend any such organism or product petitioned as an exception to this rule. Instead, the proposed rule appears to give the Secretary and the Administrator the discretion to determine what is and is not an “excluded method.” If this assumption is true, the USDA could potentially determine that a GMO, as defined under Codex/NOSB, is not an “excluded method.” OTA is concerned that this could take place without NOSB recommendation, TAP review, or public comment. OTA supports the on-going role of the NOSB in reviewing techniques and materials that could be considered “excluded methods.”

 

12. 205.2 Terms defined.

 

Insert as a new definition:

Food additive. A substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, either in the substance becoming a component of food or otherwise affecting the characteristics of food. A material used in the production of containers and packages is subject to the definition if it may reasonably be expected to become a component, or to affect the characteristics, directly or indirectly, of food packed in the container. A substance that does not become a component of food, but that is used in preparing an ingredient of the food to give a different flavor, texture, or other characteristic in the food, may be a food additive.” 

 

Rationale: The term “food additive” is not currently used in the proposed rule, but it is commonly used by organic food manufacturers and certifying agents. The definition above is taken directly from 21 CFR, §170.3, so it is consistent with the FDA’s definition.

 

13. 205.2 Terms defined.

 

Insert as a new definition:

 

Incidental additive. (i) substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect; (ii) processing aids; and (iii) substances migrating to food from equipment or packaging or otherwise affecting food that are not food additives.” 

 

Rationale: The term “incidental additive” is not currently used in the proposed rule, but it is commonly used by organic food manufacturers and certifying agents. The definition above is taken directly from 21 CFR, Ch. I §101.100(3): Food; exemptions from labeling. It is consistent with the FDA’s definition.

 

14. 205.2 Terms defined.

 

Insert as a new definition:

Ionizing radiation (irradiation). High energy emissions from radionuclides, (including, but not limited to cobalt-60 or cesium-137), capable of altering a food’s molecular structure for the purpose of controlling microbial contaminants, pathogens, parasites and pests in food, preserving a food, or inhibiting physiological processes such as sprouting or ripening, but does not include X–rays used for metal detection.” 

 

Rationale: The use of “ionizing radiation” is prohibited in 205.301(a) and 205.301(d)(3), but the term itself is not defined. Based on comments received on the last proposed rule, it is clear that the public supports a prohibition on the irradiation of organic products. In order for the prohibition of irradiation to be understood and assessed for compliance, it is critical that the term “ionizing radiation” be defined. The definition proposed above is taken from AOS, and has the broad support and understanding of the organic industry.

 

15. 205.2 Terms defined.

 

Insert as a new definition:

Manure, raw. Feces, urine, bedding, and other waste incidental to an animal, which has not been composted or processed to reduce pathogens. It does not include sewage sludge or human waste products.”

Rationale: The term “raw animal manure” is used in 205.203(c)(1), but the term is not defined. It is important that producers and certifying agents have a clear understanding of what is meant by “raw manure.” The definition above was taken from AOS. It was discussed extensively during the AOS comment process, and is widely understood and accepted by the organic community.

 

16. 205.2 Terms defined.

 

Insert as a new definition:

Management. The act, manner or practice of directing, administering, supervising, or controlling.” 

 

Rationale: The term “management” is used twenty four times, and the term “managed” is used eight times, in the proposed rule, but neither of these terms is defined. The definition above is taken from AOS. It provides a clear understanding of “management.” A clear and consistent understanding of management is essential for certifying agents to equitably assess compliance with the rule.

17. 205.2 Terms defined.

 

Mulch. Rewrite as:

 

Mulch. Any material, such as wood chips, leaves, straw, or paper; and any synthetic material, such as plastic, that is on the National List for such use, that serves to suppress weed growth, moderate soil temperature, or conserve soil moisture.”

 

Rationale: The proposed rule defines mulch as follows:

 

Mulch. Any material, such as wood chips, leaves, straw, paper, or plastic (on the National List) that serves to suppress weed growth , moderate soil temperature, or conserve soil moisture. ”

 

The rule also states in the preamble:


             “Uncomposted plant or animal waste material which has been treated with a 

             substance can be as utilized as a mulch provided the substance appears on the

            National List or complies with the OFPA.”

 

The preamble goes on to discuss the use of “organic wastes” (Federal Register 13519).

 

Taken together, it could be interpreted that all mulch materials must either be organic or be on the National List. This is unrealistic and places an undue burden on organic producers.

 

OTA supports the position NOP has taken to permit the use of non-organic plant or animal waste materials used as mulch together with the provision that they be managed to prevent contamination due to residues of prohibited substances (as stated in 205.203(c) and supported at FR13543).  The definition of “mulch” should be clarified to avoid the implication that all mulch components must be on the National List. 

 

In addition, the development of newer, longer lasting mulch materials, such as landscape fabric (geotextiles) and heavier weight plastics afford useful, benign methods of weed control for organic farmers, particularly for some perennial crops. As long as they are approved by the NOSB, placed on the National List, and removed appropriately before they degrade into the soil, they should be permitted for use.

18. 205.2 Terms defined.

 

Nonagricultural substance. Delete the second sentence of the definition.

Rationale: The term “nonagricultural substance” is a new concept, and the definition is vague and ambiguous. The term is used interchangeably with “nonagricultural product” in section 205.237 and with “nonagricultural ingredient” in the definition itself. The concept that an ingredient, product, or substance is no longer agricultural once it has been processed into an extract, isolate, or fraction, has no basis in OFPA or NOSB recommendations. It would allow the unregulated use of numerous nonorganic ingredients, since most processing activities render the finished products as unrecognizable from their original raw materials. The second sentence needs to be deleted.

 

 

19. 205.2 Terms defined.

 

Insert as a new definition:

Organic integrity. The qualities of an organic product which are obtained through adherence to organic standards at the production level, which must be maintained through handling to the point of final sale, in order for the final product to be labeled and/or marketed as organic.”

 

Rationale: The proposed definition of “system of organic production and handling” begins by focusing on “methods and substances that maintain the integrity of organic agricultural products until they reach the consumer.”  “Organic integrity” is also used in 205.272(b)(2) and 205.306(3), yet the term is not defined. The term currently is widely used by organic inspectors and certifying agents, and was repeatedly referenced by the NOSB. The definition above is from AOS. It is widely understood and supported by the organic sector.

 

20. 205.2 Terms defined.

 

Insert as a new definition:

 

Organically grown seed. Organically grown seed is seed that at least is one generation removed from conventional seed and does not contain prohibited materials; organically grown seed must be grown on certified organic ground; and must be handled so that organic integrity is maintained throughout the cleaning and packaging process.”

 

Rationale: Section 205204(a) requires the use of “organically grown seed” if it is commercially available, but no definition is provided. The definition proposed above provides producers and certifying agents with a clear understanding of what is meant by the term “organically grown seed.”

 

21. 205.2 Terms defined.

 

Insert as a new definition:

 

Pasture. Land used for grazing of livestock that is managed to maximize soil fertility, provide feed value, protect the environment from degradation, and support range land health, as approved by the certifying agent in the organic system plan.” 

 

Rationale: Access to pasture is required for ruminants in 205.239(a)(2). OTA supports this provision, but encourages NOP to include a clear definition of “pasture” in the rule. The definition above is taken from AOS. It has been widely debated, and is supported by the organic community.

 

22. 205.2 Terms defined.

 

Insert as a new definition:

Processing aid (food). Includes: (a) substances that are added to a food during the processing of such food but are removed in some manner from the food before it is packaged in its finished form; (b) substances that are added to a food during processing, are converted into constituents normally present in the food, and do not significantly increase the amount of the constituents naturally found in the food; and (c) substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food.”

 

Rationale: The term “processing aid” is used in 205.270(c)(3), 205.301(e)(1), and 205.301(e)(4), but the term is not defined. The definition above is taken from 21 CFR Ch. I (4–1–98 Edition) Subpart G—Exemptions  From Food Labeling Requirements §101.100 Food; exemptions from labeling. It is consistent with the FDA and AOS.

 

23. 205.2 Terms defined.

 

Prohibited substance. Insert after “A substance” the words “, including a product of excluded methods,” to read:


Prohibited substance. A substance, including a product of excluded methods, whose use in any aspect of organic production or handling is prohibited or not provided for in the Act or the regulations of this part.”

 

Rationale: The term “excluded methods” needs to be directly linked to the definition of “prohibited substances.” It was clear from the comments received on the last proposed rule that the public supports a prohibition on the use of genetic engineering in organic agriculture and handling. In order to support the public comments, and the will of the organic community, genetically engineered organisms (excluded methods) need to be clearly included in the definition of “prohibited substance” as proposed above.

 

24. 205.2 Terms defined.

 

Insert as a new definition:

Quality system. Documented procedures which are established, implemented, and periodically audited to assure that production, handling, management, certification, accreditation and other systems meet specified requirements and outcomes by following standardized protocols.” 

 

Rationale: The term “quality system” is not used in the proposed rule, except for in 205.640(a)(1), which discusses fees charged “by the Agricultural Marketing Service (AMS), through its Quality Systems Certification Program, to certification bodies requesting conformity assessment to the International Organization for Standardization “General Requirements for Bodies Operating Product Certification Systems” (ISO Guide 65).” The concept of a “quality system” is fundamental to ISO Guide 65, which is to be the basis for accreditation under the proposed rule, according to the preamble. It is very important for the development of program manuals and for transparent understanding of the accreditation system that the term “quality system” is defined, as proposed above.

 

25. 205.2 Terms defined.

 

Sewage sludge. Amend the definition to read:

Sewage sludge. A solid, semisolid, or liquid residue generated during the treatment of domestic sewage in a treatment works. Sewage sludge includes, but is not limited to: domestic septage; scum or solids removed in primary, secondary, or advanced wastewater treatment processes; and a material derived from sewage sludge. Sewage sludge includes ash generated during the firing of sewage sludge in a sewage sludge incinerator and grit and screenings generated during preliminary treatment of domestic sewage in a treatment works.”

Rationale: The definition of “sewage sludge” needs to include, rather than exclude, sewage sludge ash, grit, and screenings. Comments received on the last proposed rule strongly supported a prohibition on the use of sewage sludge in organic agriculture. The definition of “sewage sludge” as contained in the proposed rule allows the use of sewage sludge ash. OTA finds this to be wholly unacceptable. It should be noted that 205.602(a) prohibits “ash from manure burning.” Sewage sludge ash must also be prohibited.

 
 
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