Spring 2019 NOSB Meeting

• Assessing Cleaning and Sanitation Materials

  • Submit your own comments here
  • Background:The Materials Subcommittee has outlined many of the issues that should be covered regarding sanitizers, but they need to be addressed within a framework that first identifies the needs for cleaning and sanitizing materials in organic production and handling. A comprehensive review of sanitizers as a review should begin with identifying the needs of organic producers and handlers for cleaning and sanitizing materials.

    Such a review should start with the questions:

    1. For what purposes are cleaning and sanitizing materials needed?
    2. Are specific (e.g., chlorine-based) cleaning and sanitizing materials required by law?

    Both in terms of a strict reading of OFPA and common sense, all cleansers and antimicrobials used in organic production and handling should be on the National List, regardless of subsequent rinsing.

• Marine Materials

  • Submit your own comments here
  • Background: The protection of marine ecosystems is urgently important, and since marine plants are crucial to those ecosystems, it is important for all of us, as organic producers, consumers, certifiers, and regulators, to find a way to move this process forward. We must set enforceable, protective rules for the use of marine algae in organic production. Enforceability implies rules that are verified by on-site inspection and that will stand up to legal challenge. Protective rules must address not only the sustainability of the target marine algae, but also the marine ecosystem and biological communities in which they live. We suggest that annotation is the most effective way to introduce enforceable, protective rules for marine algae. Annotation is not subject to discretionary alteration without a decisive vote of the NOSB. On the other hand, because the listings are reviewed on a five-year cycle, they can be modernized when needed.  

• Oversight Improvements to Deter Fraud Discussion Document

• Submit your own comments here
• Background: Fraud is a problem for all food labeled organic, whether produced domestically or outside the U.S. It is a problem whenever someone or a company portrays as organic a product that does not meet the standards for organic certification. Fraud hurts all sectors of the organic community –especially organic producers who follow the letter and spirit of the law and the consumers who depend on the market to provide organic food that meets organic standards. Fraud is a problem when, for example, crops are grown with prohibited inputs, when livestock do not get the required access to pasture, and when crops are produced in artificial media and, therefore, not in compliance with organic standards. The problems of inadequate oversight and enforcement by NOP go beyond imports of organic grains and also include poultry animal welfare, access to pasture for dairy, hydroponics, and aquaculture. We suggest specific remedies to these problems and also suggest programmatic changes to prevent future problems:  
• Imported Grain: USDA should institute heightened procedures to ensure that all organic imports are meeting USDA organic standards. 
• Poultry: USDA should put into effect the Organic Livestock and Poultry Practices proposed.  
• Dairy: The NOSB should urge USDA to take immediate action to bring bad actors in the dairy sector and their organic certifying agents into compliance, or exclude them from the program. 
• Hydroponics: The NOSB should insist that hydroponics operations be decertified until regulations are adopted that provide standards for their management. 
• Aquaculture: The NOSB should insist that products of aquaculture not be certified organic in the U.S. without standards proposed by the NOSB and adopted by NOP. 
• Conflict of Interest: The NOSB should recommend precautionary measures to ensure that there is no conflict of interest in the oversight of certifiers. 
• General: The Peer Review Panel must be convened regularly. The procedures used to implement the Peer Review Panel must be publicly accessible. Its membership should be determined by the NOSB, not the NOP, and it should have the authority to request any files and evaluate any certifier that it judges to be appropriate.  

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Petitions

• Allyl isothiocyanate (AITC)

• Submit your own comments here
• Background: The NOSB should not include allyl isothiocyanate (AITC) on the National List because it does not meet any of the criteria in the Organic Foods Production Act (OFPA) for allowing an exemption. It poses environmental and health hazards, is not essential for organic production, and is not compatible with organic practices. 

  It would be difficult to find a practice less compatible with organic production than soil fumigation with a “broad-spectrum antimicrobial compound that effectively kills both plant pathogens and beneficial soil microorganisms.” Organic production uses practices that feed soil organisms who feed crop plants. It creates healthy soil food webs. Using a toxic chemical to wipe out soil biology is the antithesis of organic practices.

• Ammonium Citrate

• Submit your own comments here
• Background: Ammonium citrate should not be included on the National List because OFPA criteria have not been appropriately addressed. The impacts of the manufacturing process, hazards posed by “inert ingredients” and micronutrients, and necessity for chelated minerals have not been adequately evaluated. If ammonium citrate is listed as petitioned, it will lead to unforeseen use associated with significant hazards. However, it may make sense to consider a petition to amend §205.601(j)(6) to allow micronutrients such as citrates or glycinates. Such consideration should examine possible effects of the chelating agents and ammonia on the soil.

• Ammonium Glycinate

  • Submit your own comments here
  • Background: Ammonium glycinate should not be included on the National List because OFPA criteria have not been appropriately addressed. The impacts of the manufacturing process, hazards posed by “inert ingredients” and micronutrients, and necessity for chelated minerals have not been adequately evaluated. If ammonium glycinate is listed as petitioned, it will lead to unforeseen use associated with significant hazards. However, it may make sense to consider a petition to amend §205.601(j)(6) to allow micronutrients such as citrates or glycinates. Such consideration should examine possible effects of the chelating agents and ammonia on the soil.

• Calcium Acetate

  • Submit your own comments here
  • Background: Calcium acetate should not be included on the National List because it is incompatible with organic production practices and is not essential for organic production. The proposed use of calcium acetate for direct plant nutrition is incompatible with organic production, in which the grower feeds the soil organisms, which feed the plants. The second proposed use of calcium acetate – to reduce heat stress caused by black plastic mulch – is similarly incompatible with organic practices, as it calls for the application of a synthetic material in order to overcome the problems inherent in the use of another synthetic material. The technical review documents nonsynthetic materials for calcium provision and alternative practices for sunscald protection that should be considered in lieu of synthetic calcium acetate.

• Paper pots discussion document

  • Submit your own comments here
  • Background: A technical review addressing paper pots in reference to OFPA criteria has been requested, and should provide more information about: (1) the paper and adhesives used in the paper pots, (2) the source of the pulp used in pots produced by the petitioner and others, and (3) an estimate of the scale of production.
    The NOSB should use the information in the new TR to better assess the environmental impacts of these pots in comparison to recycled paper that is now allowed as mulch. Based on this review, the CS should develop a proposal that contains an annotation clarifying the materials and manufacturing processes that would be allowed. The NOSB should facilitate support for the domestic production of paper pots that are compatible with organic principles. 

Sunset

• Hydrogen peroxide

  • Submit your own comments here
  • Background: Hydrogen peroxide should be relisted. Although concentrated hydrogen peroxide is a powerful oxidizer, the advantage of hydrogen peroxide is its nontoxic residue. Hydrogen peroxide has been identified as a “safer” sanitizer by EPA’s Design for the Environment Program (aka Safer Choice Program).

• Soaps, ammonium

  • Submit your own comments here
  • Background: Ammonium soaps should be allowed to sunset because they do not meet any of the three OFPA criteria of absence of harm to humans and the environment, essentiality, and compatibility with organic practices. Drift from spraying ammonium soaps may damage plants and kill aquatic insects. Alternative materials include area repellents, including tankage (putrified meat scraps), bone tar oil, blood meal, human hair, and bar soap –which should be applied close to or on the plants needing protection– and contact repellents that work by taste and are applied directly to plants, including putrescent egg solids and hot pepper sauce. Other methods include habitat modification, hunting, shooting, fencing/exclusion, encouraging predators.

• Oils, horticultural (Narrow range oils)

  • Submit your own comments here
  • Background: The listing for horticultural oils should be annotated in a way that protects workers from inhalation hazards, and nontarget arthropods from harm. If this is not possible, horticultural oils should be delisted. We suggest this annotation: “Steps to meet worker protection standards must be documented in the Organic System Plan. Must not be used when predators, parasitoids, or pollinators are present.”

• Pheromones

  • Submit your own comments here
  • Background: We support the following listing for pheromone products, which we believe captures the sense of the conditions for exempting pheromone products from regulation:

    §205.601(f) As insect management. Pheromones, provided that they are identical to or substantially similar to natural pheromones as defined in 40 CFR 152.25(b), in passive dispensers, without added toxicants, and with only approved inert ingredients. 

    Despite the lack of specificity, pheromone products have permitted growers to avoid the use of more toxic controls. They can be used in a way that complements alternative methods suggested by the technical review: biological controls, traps, repellents, soil management, sanitation, other cultural practices, physical barriers, hand removal.

• Ferric phosphate

  • Submit your own comments here
  • Background: Ferric phosphate should be allowed to sunset because ferric phosphate alone is ineffective, therefore not essential, and ferric phosphate in combination with EDTA (ethylenediaminetetraacetic acid) poses risks to soil organisms, uses highly toxic materials in manufacture, and is not compatible with organic agriculture.

• Potassium bicarbonate

  • Submit your own comments here
  • Background: Potassium bicarbonate should be removed from the list because it does not fit into any of the categories of allowable synthetics in §6517(c)(1)(B)(i) of OFPA, which is limited to: copper and sulfur compounds; toxins derived from bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and minerals; livestock parasiticides and medicines and production aids.

• Magnesium sulfate

  • Submit your own comments here
  • Background: Magnesium sulfate is acceptable only under limited conditions. Synthetic plant nutrients should not be taking the place of organic soil-building practices. Synthetic magnesium sulfate is a synthetic plant nutrient, and hence its use as a foliar spray is contrary to the organic philosophy of feeding the soil to feed the plants. Magnesium should be abundant in biologically active soils, so organic soil-building practices should be used to enrich soils with magnesium.

• Hydrogen chloride

  • Submit your own comments here
  • Background: Hydrogen chloride should be relisted due to the lack of alternatives of organic cotton growers. However, in view of the extreme hazard posed by gaseous hydrogen chloride, NOSB should call for support for research and development of alternative methods of delinting cotton seed in preparation for planting.

• Ash from manure burning

  • Submit your own comments here
  • Background: Ash from manure burning should remain on §602, nonsynthetic substances prohibited for use in organic crop production. Burning a material that is central to maintaining soil fertility and tilth in organic soils would be incompatible with organic production systems.

• Sodium fluoaluminate (cryolite)

  • Submit your own comments here
  • Background: Sodium fluoaluminate (cryolite) should remain on §602, nonsynthetic substances prohibited for use in organic crop production. Cryolite is harmful to human health and the environment. It is a nonselective pesticide, and there are alternative materials and management practices.  

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Other Issues

• Strengthen and clarify the requirements for use of organic seed

  • Submit your own comments here
  • Background: NOSB should strengthen organic seed guidance. NOP’s broad exemption allowing the use of conventionally produced seed maintains inconsistency in the enforcement of organic standards. Enforcement must be a first step to strengthening the organic seed requirement –certifiers must enforce consistent and uniform adherence to the present organic seed requirements.

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Petitions 

• Silver dihydrogen citrate

  • Submit your own comments here
  • Background: The NOSB, noting universal public opposition to the use of nanotechnology and engineered nanomaterials in organic production, voted to exclude engineered nanomaterials in 2010. Therefore, the board should not list silver dihydrogen citrate without the proposed annotation prohibiting nanosilver. There are sufficient demonstrated health and environmental hazards associated with silver dihydrogen citrate as a source of ionic silver to reject the petition.
    Silver dihydrogen citrate poses health and environmental risks particularly the risk of increasing resistance to antibiotics and silver-based medications. There is ample evidence, though insufficiently documented in the recent technical review, that both ionic silver and nanosilver are toxic not only to microbes, but to other species as well. The petition for silver dihydrogen citrate (SDC) must be denied to protect human health and the environment and ensure the effectiveness of remaining antimicrobial medications.

• Pullulan

  • Submit your own comments here
  • Background: In view of the problems that may arise from exposure to the parent organism, Aureobasidium pullulans, the use of pullulan should not be expanded beyond the current use, and pullulan must be listed on labels of “made with organic” supplement tablets and capsules. Aureobasidium pullulans exists as many strains with a large variety of ecological niches, including (as stated in the petition) “forest soil, fresh and sea water, plant and animal tissues.” It is known as a human pathogen, a human allergen, a biological control agent in plants, and in biotechnology for production of the polysaccharide pullulan and the antifungal aureobasidin A.

• Collagen Gel (casing)

  • Submit your own comments here
  • Background: Collagen gel casings should not be added to the list of allowed nonorganic agricultural materials because collagen gel casings are synthetic, the listing discourages the development of organic collagen gel casings, and the contamination from nonorganic feedlots and other practices poses environmental and health hazards.
    Collagen gel casings are synthetic, containing approximately equal parts collagen and cellulose, which is listed as a synthetic on the National List. Moreover, non-organic collagen gel casings derived from animals raised in concentrated animal feeding operations (CAFOs) contaminate organic products with toxic pesticides and other chemicals widely recognized as hazardous to farmworkers, the environment, and consumers.
    It is time to stop adding to the list of allowed nonorganic agricultural materials.When organic production was in its infancy, it made sense to allow a small proportion of non-organic ingredients in processed organic foods if they were not available in organic form. However, now that any agricultural commodity can be produced organically, such listing only stifles organic production of new organic crops and promotes chemical-intensive production. Instead of petitioning for the use of casings made from meat contaminated with pesticide and antibiotic residues, those who wish to use collagen gel casings for organic sausage should devote their efforts to eliminating practical obstacles to sourcing organic collagen.

Sunset

• Celery powder

• Submit your own comments here
• Background: Celery powder should not be relisted, because its production in chemical-intensive agriculture results in health and environmental hazards. The use of celery powder is a way of artificially adding nitrate as a preservative at levels not possible to achieve through use of organic celery. Nitrates pose dangers to health when artificially enhanced in food. The evaluation of celery powder must take into consideration the use of pesticides in the non-organic production of celery and the availability of organic celery for this purpose, as well as its potential availability if the demand existed.

• Fish oil

• Submit your own comments here
• Background: Many organic consumers do want the benefits they could get from fish oil, but others are sensitive to the problems of contamination and overfishing. And organic fish, even if available, would be a net negative impact under current production practices, given that 81% of the world’s supply of fish oil goes to feed fish. Although processing of fish oils reduces the levels of contaminants, many of those present in fish oil have no threshold for their negative effects (e.g., cancer). In support of the conservation of biodiversity fish oil should not be relisted until sustainable practices can be defined to conform to organic standards in compliance with OFPA.

• Gelatin

• Submit your own comments here
• Background: The evaluation of gelatin must take into consideration the use of pesticides in the non-organic production of corn and soybeans and ensure that GMO grains are not used in producing organic products. The NOSB must consider the availability of organic meat byproduct for this purpose, as well as the potential availability of gelatin if the demand was enhanced by removal of this listing.

• Orange pulp, dried

• Submit your own comments here
• Background:Dried orange pulp should not be relisted, because it is produced by practices dangerous to workers and the environment. The database shows that while oranges grown with toxic chemicals show low pesticide residues on the finished commodity, there are 73 pesticides with established tolerance for oranges, of which 30 are acutely toxic creating a hazardous environment for farmworkers, 66 are linked to chronic health problems (such as cancer), 19 contaminate streams or groundwater, and 60 are poisonous to wildlife.

• Seaweed, Pacific kombu

• Submit your own comments here
• Background: Pacific kombu should be allowed to sunset because of the issues of contamination and overharvesting. Annotations requiring testing for heavy metals and radioactivity and prevention of overharvesting would protect organic consumers and the environment. The NOSB must consider the question of whether the allowance of the use of wild kombu is adequately protective. As the NOSB considers criteria for the use of marine plants in organic crop production, it should also examine the use of marine plant and animal products as ingredients in organic foods and how to apply standards protecting the marine environment.

• Seaweed, Wakame (Undaria pinnatifida)

• Submit your own comments here
• Background:Wakame should be allowed to sunset because of the issues of contamination and overharvesting. Like other seaweeds, wakame concentrates heavy metals, including arsenic. Annotations requiring testing for heavy metals and radioactivity and prevention of overharvesting would protect organic consumers and the environment.

• Alginic acid

• Submit your own comments here
• Background: Alginic acid should be delisted due to environmental impacts, lack of essentiality, and incompatibility with organic processing.The 2015 Technical Review (TR) of alginic acid raises issues associated with brown seaweed cultivation for alginic acid, including increased sediment deposits, depletion of nutrients, possible impacts of nutrients added (organic and synthetic sources of nitrogen), and the introduction of non-native species. Alginic acid is a synthetic that is used to improve textures of soup and soup mixes as sold.” This purpose is prohibited for a synthetic substance. Furthermore, the TR lists many natural and organic substitutes.

• Calcium chloride

• Submit your own comments here
• Background: We consider the level of impurities in food grade calcium chloride – up to 6% – to be high for a food grade material. The presence of calcium bromide is troublesome. We recommend that the HS investigate this more closely.

• Citric acid

• Submit your own comments here
• Background: Citric acid should be removed from §205.605(a) and considered for listing as a synthetic on §205.605(b) unless it is possible to define nonsynthetic citric acid by annotation. The earlier judgment that citric acid is nonsynthetic was based on a much less complete description of the fermentation and purification processes than is available in the TR. It should be revisited.

• Dairy cultures

• Submit your own comments here
• Background: Dairy cultures per se meet OFPA requirements, but there are many ancillary substances that must be reviewed. A new technical review should be conducted with attention to the specific microorganisms used in dairy cultures.

• Enzymes

• Submit your own comments here
• Background: Enzymes should be classified as synthetic unless annotated to define those that have not undergone synthetic chemical change. The review of ancillary substances should include all such substances, including those on the National List.
  

• Lactic acid

• Submit your own comments here
• Background: L-lactic acid should be reclassified as synthetic and considered for listing on §205.605(b). L-lactic acid is also present in some foods by virtue of in situ fermentation, and this is not synthetic. The microorganisms responsible for the fermentation are on the National List.

• L-Malic acid

• Submit your own comments here
• Background:L-malic acid should be allowed to sunset because the database does not support the decision to relist. The principal document of support is a Technical Advisory Panel (TAP) review of DL-malic acid, the synthetic form, which does not address the manufacture of L-malic acid by fermentation. Given the inadequacies of the documentation, the HS should request a supplemental TR to document environmental and health impacts, as well as the need for the material.

• Magnesium sulfate

• Submit your own comments here
• Background:If the NOSB accepts the judgment of TR authors, then magnesium sulfate should be classified as synthetic, removed from §205.605(a), and (if there is support) petitioned for §205.605(b).

• Microorganisms

• Submit your own comments here
• Background:Microorganisms should not be relisted without documentation to show that the listing meets the criteria of the Organic Foods Production Act (OFPA). The principal document of support is a technical review (TR) that does not address the manufacture of microorganisms by fermentation.

• Perlite

• Submit your own comments here
• Background:Perlite should be relisted because is an excellent filter aid and often substitutes for diatomaceous earth in filtering beer. The subcommittee received clear indication from a range of stakeholders that perlite continues to be necessary.

• Potassium iodide

• Submit your own comments here
• Background:Potassium iodide should be relisted with the annotation, “as a source of iodine when required by law.” The NOSB must restrict supplemental vitamins and minerals to those required by law. A review of sanitizers is needed to determine which are needed and compatible with organic practice.

• Yeast

• Submit your own comments here
• Background: Yeast per se meets OFPA requirements, however there are many ancillary substances that have not been reviewed, some of which may be problematic.

• Activated charcoal

• Submit your own comments here
• Background:Activated charcoal should not be relisted as currently allowed. The use, as petitioned, to improve the color and flavor of grape juice, is not compatible with organic production and handling. The listing should limit its use to filtering water and require steam activation.

• Ascorbic acid

• Submit your own comments here
• Background:Ascorbic acid should be removed from the National List because it is a synthetic antioxidant/preservative, and there are natural and organic alternatives.

• Calcium citrate

• Submit your own comments here
• Background:The use of citrates should be restricted to those that are in compliance with §205.600(b)(4). The earlier judgment that citric acid is nonsynthetic was based on a much less complete description of the fermentation and purification processes than is available in the technical review, and should be revisited.

• Ferrous sulfate

• Submit your own comments here
• Background:Ferrous sulfate should be phased out. Iron fortification is required for “enriched” cereal and flour products, but in those cases, a form of iron that is less destructive of other food values should be substituted. Alternatively, less processed forms of food can be used that do not require fortification.

• Hydrogen peroxide

• Submit your own comments here
• Background:Hydrogen peroxide should be relisted because, though concentrated hydrogen peroxide is a powerful oxidizer, it is relatively nontoxic in low concentrations and has the advantage of nontoxic residue. It breaks down quickly to oxygen and water, and therefore does not have a residual effect.

• Nutrient vitamins and minerals

• Submit your own comments here
• Background:The listing of nutrient vitamins and minerals should be amended to restrict the use of any supplemental vitamins and minerals to only those instances in which FDA regulations require such supplementation.

• Peracetic acid

• Submit your own comments here
• Background:Peracetic acid should be relisted for use in handling because compared to alternatives, it is relatively harmless, effective, and compatible with organic handling practices.

• Potassium citrate

• Submit your own comments here
• Background:The use of citrates should be restricted to those that are in compliance with §205.600(b)(4). The earlier judgment that citric acid is nonsynthetic was based on a much less complete description of the fermentation and purification processes than is available in the technical review, and should be revisited.

• Potassium phosphate

• Submit your own comments here
• Background: The NOSB should seek to eliminate the use of inorganic phosphates such as potassium phosphate in organic food. If it is not possible to totally eliminate them, the listings should be annotated to eliminate uses prohibited by §205.600(b)(4).

• Sodium acid pyrophosphate

• Submit your own comments here
• Background:Sodium acid pyrophosphate should not be relisted because it does not meet the criteria of lack of harm to the environment and human health, essentiality, and compatibility. [S]odium pyrophosphate has similar subacute effects to the more toxic orthophosphates, including kidney damage and calcium deposits in test animals. According to the TAP review, “The toxicity of sodium phosphates is generally related to the sequestration of calcium and the subsequent reduction of ionized calcium. It is an irritant, and ingestion may injure the mouth, throat, and gastrointestinal tract, resulting in nausea, vomiting, cramps, and diarrhea.”

• Sodium citrate

• Submit your own comments here
• Background:The use of citrates should be restricted to those that are in compliance with §205.600(b)(4). The earlier judgment that citric acid is nonsynthetic was based on a much less complete description of the fermentation and purification processes than is available in the technical review, and should be revisited.

• Tocopherols

• Submit your own comments here
• Background:The Handling Subcommittee must investigate the availability of natural tocopherols. If natural tocopherols are available, then they should be removed from §205.605(b) and petitioned for §205.605(a). The NOSB should encourage the production of organic tocopherols by placing an expiration date on the §205.605(a) listing. 

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 Petition

•  Oxalic Acid

  • Submit your own comments here
  • Background: Oxalic acid is petitioned for use in controlling varroa mites in organic beehives. Since there are no practice standards for organic apiculture, the NOSB lacks a framework for making a decision on this and other materials used by organic beekeepers. We suggest, therefore that this petition be put on hold until such standards are adopted. A panel of organic beekeepers would be helpful to the NOSB and NOP in prioritizing apiculture standards and making decisions concerning materials used in organic apiculture.

Sunset

• (Parasiticide) Fenbendazole

• Submit your own comments here
• Background:Although fenbendazole has fewer known adverse effects than ivermectin, the definition and clarification of “emergency” approved by the NOSB must be added to the regulations. We regard the listing with shorter withholding periods in the absence of the NOSB-recommended definition to be a violation of OFPA §6517(d)(2), which prohibits USDA from adding uses of synthetics “other than those exemptions contained in the Proposed National List or Proposed Amendments to the National List.”

• (Parasiticide) Moxidectin

  • Submit your own comments here
  • Background: Although moxidectin has fewer known adverse effects than ivermectin, the definition and clarification of “emergency” approved by the NOSB must be added to the regulations. We regard the listing with shorter withholding periods in the absence of the NOSB-recommended definition to be a violation of OFPA §6517(d)(2), which prohibits USDA from adding uses of synthetics “other than those exemptions contained in the Proposed National List or Proposed Amendments to the National List.”

• Atropine

  • Submit your own comments here
  • Background: Atropine should be relisted due to its essentiality as an antidote for organophosphate poisoning and usefulness as an antispasmodic. The technical review describes it as a benign treatment without a holistic or natural alternative.

• Hydrogen peroxide

  • Submit your own comments here
  • Background: Hydrogen peroxide should be relisted because it is a safer alternative to chlorine-based and other toxic sanitizers.

• Magnesium sulfate

  • Submit your own comments here
  • Background: Magnesium sulfate has a number of veterinary uses. We look forward to seeing the response of livestock producers to the LS question regarding the need for the material.

• Peracetic acid

  • Submit your own comments here
  • Background: Peracetic acid should be relisted because of its utility as a replacement for chlorine compounds and its innocuous degradation products.

• Xylazine

  • Submit your own comments here
  • Background: An off-label use may be allowable in the absence of a specific prohibition, but since FDA does explicitly prohibit the use of xylazine in food-producing animals, it should be delisted. Since tolazoline is limited to use as an antidote to xylazine, it should also be removed from the National List.

• Iodine

  • Submit your own comments here
  • Background: The iodine listings should not permit iodophors containing alkylphenols or alkylphenol ethoxylates. They should be annotated “without alkylphenols or alkylphenol ethoxylates.”

• Methionine

  • Submit your own comments here
  • Background: The NOSB should delist synthetic methionine or add an expiration date to force serious reconsideration. The current listing of methionine is based on inadequate support for a regulatory decision that reverses a previous NOSB decision to phase out methionine and incentivize alternative approaches to managing poultry. The listing of synthetic methionine must be considered in the context of an organic management system. The “need” for synthetic methionine is a result of choices regarding poultry flock breeds, stocking rates (both density and group size), and outdoor access. Increasingly, consumers are turning to eggs and meat produced in pastured poultry systems, which require fewer synthetic inputs. In the time since the last consideration of synthetic methionine by the NOSB, there have been advances in the use of insects – specifically black soldier fly larvae — as a source of natural methionine. However, organic poultry producers and the NOSB should not limit their consideration to one source. Synthetic methionine is not necessary for animal welfare. Studies show that reduced stocking rates (both density and group size), outdoor access, and slower-growing birds (who use the outdoors more effectively), but not synthetic methionine and cysteine, have a positive impact on the welfare of poultry.

• Trace minerals

  • Submit your own comments here
  • Background:Organic production should not be dependent on synthetic nutrients. While we realize that the variability in forage and feeds may occasionally lead to a need for supplementation, the existing annotation is not restrictive enough to prevent reliance on synthetic materials. Therefore, we recommend adding the annotation, “when forage and available natural feeds are poor quality.”

• Vitamins

  • Submit your own comments here
  • Background: The listing for vitamins should be replaced with one for vitamins A, C, and D because the need for synthetic forms of others is not supported.

Other Issues

• Vaccines made with excluded methods annotation discussion document

  • Submit your own comments here
  • Background: We favor a policy of allowing vaccines made by excluded methods only when there are no commercially available vaccines that are not produced through excluded methods to prevent that specific animal disease or health problem and the specific health problem poses an emergency. We suggest an approach to defining “emergency” in this situation that is parallel to that used for defining emergency use of parasiticides. Regardless of the approach taken, it will need to be informed by a list of available vaccines. It appears that such a list is available through APHIS.

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• Marine materials (marine algae and extracts) Discussion Document (See Cross-Cutting Issues)

• Submit your own comments here
• Background: The protection of marine ecosystems is urgently important, and since marine plants are crucial to those ecosystems, it is important for all of us, as organic producers, consumers, certifiers, and regulators, to find a way to move this process forward. We must set enforceable, protective rules for the use of marine algae in organic production. Enforceability implies rules that are verified by on-site inspection and that will stand up to legal challenge. Protective rules must address not only the sustainability of the target marine algae, but also the marine ecosystem and biological communities in which they live. We suggest that annotation is the most effective way to introduce enforceable, protective rules for marine algae. Annotation is not subject to discretionary alteration without a decisive vote of the NOSB. On the other hand, because the listings are reviewed on a five-year cycle, they can be modernized when needed.
• Genetic Integrity Transparency of Seed Grown on Organic Land
• Submit your own comments here
• Background: It is important to protect the genetic integrity of organic crops. In this context, it is important to have a protocol for those cases in which organic seed is not available. More data collection is needed to track contamination risks and to inform seed purity standards. A testing requirement is needed for testing of indicators of genetic engineering, and should capture genetically engineered seeds that have been commercialized up to this point.

• Excluded Methods Determinations

• Submit your own comments here
• Background:
• Transposons: Transposons arising from environmental stress, such as heat, drought, or cold, are not excluded methods, and transposons developed with the use of in vitro nucleic acid techniques are excluded methods.
• Cisgenesis and Intragenesis: The definitions of cisgenesis and intragenesis should be accepted, but suggest that the NOSB also give explanations more easily understood by the lay reader.

• Induced Mutagenesis Embryo Transfer Discussion Document

  • Submit your own comments here
  • Background: 
  • Induced Mutagenesis: As in the case of transposons, mutagenesis arising from environmental stress can be distinguished from directed mutagenesis or gene editing. Directed mutagenesis should be considered an excluded method. 
  • Embryo Transfer in Livestock: Offspring resulting from embryo transfer that involves treatment of either the donor or recipient with hormones or other prohibited substances should not be permitted to be certified organic.
    

• Assessing Cleaning and Sanitation Materials Discussion Document (See Cross-Cutting Issues)

  • Submit your own comments here
  • Background: The Materials Subcommittee has outlined many of the issues that should be covered regarding sanitizers, but they need to be addressed within a framework that first identifies the needs for cleaning and sanitizing materials in organic production and handling. A comprehensive review of sanitizers as a review should begin with identifying the needs of organic producers and handlers for cleaning and sanitizing materials. Such a review should start with the questions:

  1. For what purposes are cleaning and sanitizing materials needed?

• 2.  Are specific (e.g., chlorine-based) cleaning and sanitizing materials required by law?

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  Both in terms of a strict reading of OFPA and common sense, all cleansers and antimicrobials used in organic production and handling should be on the National List, regardless of subsequent rinsing.

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Policy Development

No proposals or discussion documents have been advanced by the PDS.

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