225 Gateway Boulevard 650 780 4777 main solazyme.com S San Francisco CA 94080 650 989 6700 fax September 6, 2013 National List Manager USDA/AMS/NOP, Standard Division 1400 Independence Ave, SW Room 2648-So., Ag Stop 0268 Washington, DC 20250-0268 RE: National List Petition for inclusion of Whole Algal Flour to 7 CFR 205.606 To Whom It May Concern, In accordance with 72 FR 2167 (dated January 18, 2007), Solazyme, Inc. respectfully submits our petition for Whole Algal Flour to be considered for inclusion on the National Organics List under 7 CFR 205.606 – Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” There has been much debate on organisms such as algae and whether it should be considered potentially agricultural or nonagricultural. In the past, the Materials Review Board indicated that algae may be considered agricultural because they are photosynthesizing plants. However, it should be noted that algae is also a single-celled organism (microorganism) which could place it in 205.605(a) – Nonagricultural (nonorganic) substance (non-synthetic). The particular strain of algae used to make Whole Algal Flour is not cultivated in a soil-based system and is also not photosynthetic; it is a heterotrophic alga that does not use sunlight for growth but instead is cultured in fermenters. Under the suggestion of the NOP, we are submitting this petition under 205.606, however we would like the NOSB to consider placing Whole Algal Flour under 205.605 (a) based on the non-photosynthetic nature and the manufacturing process of the organism used to produce our substance. If you have any questions, please feel free to contact me. Regards, Teresa Chan Regulatory Affairs Manager [email protected] Tel: 650-780-4777 x5321 Page 1 of 24 Item A 1. Please indicate which section or sections the petitioned substance will be included on and/or removed from the National List. 7 CFR 205.606 – Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).” However, we would like to be considered for 7 CFR 205.605(a) based on the heterotrophic nature of the algae and the manufacturing process of the organism used to produce our substance. Item B 1. The substance’s chemical or material common name. Whole Algal Flour 2. The manufacturer’s or producer’s name, address and telephone number and other contact information of the manufacturer/producer of the substance listed in the petition. Manufacturer Solazyme, Inc. 225 Gateway Blvd S. San Francisco, CA 94080 Tel: 650-780-4777 Contact Person Teresa Chan Regulatory Affairs Manager 225 Gateway Blvd S. San Francisco, CA 94080 Tel: 650780-4777 x 5321 [email protected] 3. The intended or current use of the substance such as use as a pesticide, animal feed additive, processing aid, nonagricultural ingredient, sanitizer or disinfectant. If the substance is an agricultural ingredient, the petition must provide a list of the types of product(s) (e.g., cereals, salad dressings) for which the substance will be used and a description of the substance’s function in the product(s) (e.g., ingredient, flavoring agent, emulsifier, processing aid). Page 2 of 24 Whole Algal Flour is a whole food ingredient used as either a partial replacement for food ingredients that provide dietary fat and/or protein such as cream, milk, eggs/egg yolks, and/or butter/shortening in baked goods, beverages, dairy and egg products, sauces, gravies, margarines, salad dressings, and soups or as an added ingredient for texture and mouth feel enhancement. 4. A list of the crop, livestock or handling activities for which the substance will be used. If used for crops or livestock, the substance’s rate and method of application must be described. If used for handling (including processing), the substance’s mode of action must be described. Whole Algal Flour will replace a portion of cream, milk, eggs/egg yolks, and/or butter/shortening in a variety of conventional foods, including baked goods, beverages, dairy and egg products, sauces, gravies, margarines, salad dressings, and soups. As a replacement source of macronutrients and energy, the lipids, proteins, fiber and carbohydrates found in Whole Algal Flour will be digested through the same normal physiological processes by which other dried, ground plant materials common to the human diet are digested and utilized. 5. The source of the substance and a detailed description of its manufacturing or processing procedures from the basic component(s) to the final product. Whole Algal Flour is a whole food product made from a family of algae long consumed in other cultures globally. Microalgae, such as Chlorella spp., have been an accepted part of the human diet for hundreds of years, especially among the populations of Asia and sub-Saharan Africa.1 Whole Algal Flour is manufactured by fermenting and harvesting cultures of a non- toxigenic strain of Chlorella protothecoides. A pure, clonally isolated culture is initially used to prepare a master seed bank from which working seed vials are prepared. Three samples from the master and each working seed bank are characterized by molecular genotyping to demonstrate that they are genetically identical (i.e., 100% homology between the six chromosomal footprints and 100% homology between their 23S ribosomal deoxyribonucleic acid (DNA) sequences).2 For a production lot, a cryo- preserved working seed vial is thawed and the contents used to inoculate a flask culture, which is transferred into larger flasks at mid-log phase, and then to standard, industrial seed fermenters. Throughout the fermentation process, pH, temperature, agitation and aeration rates are controlled, and glucose or sucrose and nutrients are added. Lipid production is induced by limiting inorganic nitrogen during the fermentation process. Currently, production is done in the United States. Following completion of 1 (Kay, 1991; Ravishankar et al., 2006). 2 When tested, the six 23S ribosomal DNA sequences also demonstrated 100% identity to the 23S reference sequence for the original C. protothecoides S106 isolate. Page 3 of 24 fermentation, the cells are inactivated by pasteurization, and separated from the culture broth by centrifugation. The separated cells are washed with water to remove the medium and other non-biomass related material and concentrated. The pH is adjusted to neutral with caustic material such as potassium hydroxide or sodium hydroxide. At this step, the material can be provided without additional ingredients, but for some customers, food-grade antioxidants (e.g., mixed tocopherols) may be necessary to keep the product suitable for incorporation in end products. The antioxidants would be present at insignificant levels and are unlikely to have any technical effect in the final formulation. They could be considered processing aids for the end-user’s application. The end user must make that determination. Our use of antioxidants is to meet customer commitments and can be provided without them to customers who request it. The biomass is then homogenized, dried and packaged. If needed, food grade flow agents may be added to assist processing through drying and packaging; at present the use of such agents is not part of the standard process. All ingredients used during manufacture are safe and suitable. The final product, Whole Algal Flour, is available in quantities of 15 – 25 kg packed in a bag-in-box arrangement and stored at temperatures < 25 ºC. 6. A summary of any available previous reviews by State or private certification programs or other organizations of the petitioned substance. Whole Algal Flour has been self- affirmed as generally recognized as safe (GRAS). The determination that Whole Algal Flour is GRAS is on the basis of scientific procedures as a Food Ingredient. There is consensus among experts, qualified by scientific training and experience to evaluate the safety of substances added to food, that Whole Algal Flour is GRAS under the intended conditions of use. 7. Information regarding EPA, FDA, and State regulatory authority registrations, including registration numbers. A GRAS Notification was submitted to FDA (GRN 469) and a No Questions Letter from FDA was received on June 7, 2013.3 8. The Chemical Abstract Service (CAS) number or other product numbers of the substance and labels of products that contains the petitioned substance. Whole Algal Flour does not have a CAS number. See Appendix I for a copy of the label. 3 <http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm361155.htm>; site accessed June 17, 2013 Page 4 of 24 9. The substance’s physical properties and chemical mode of action including: Whole Algal Flour is a golden yellow high lipid powder composed of the dried biomass of the green microalgae Chlorella protothecoides. Whole Algal Flour is a mixture of fiber, ash, protein, fat, and sucrose and acts as a source of macronutrients as partial replacement for cream, milk, egg/egg yolks, and/or butter/shortening. It is digested through the same normal physiological processes by which other dried, ground plant materials common to the human diet are digested and utilized. Table 1 shows the physical and chemical properties of Whole Algal Flour. Characteristic Value Synonyms High lipid Algal flour (HLAF), Algal flour, Algal flour Appearance Golden yellow powder Moisture Content ≤ 10 % Fiber Content 10 – 50 % Ash Content < 10 % Protein Content 2 – 15 % Fat Content 40 – 70 % Lead (ppm) < 0.5 Arsenic (ppm) < 0.2 Mercury (ppm) < 0.1 Cadmium (ppm) < 0.1 Chromium (ppm) < 2 Table 1. Physical and chemical properties of Whole Algal Flour a) Chemical interactions with other substances, especially substances used in organic production; Whole Algal Flour is not known to have any chemical interactions with other substances. b) Toxicity and environmental persistence; Whole Algal Flour is derived from natural microalgae, which is inherently biodegradable. c) Environmental impacts from its use and/ or manufacture; There are no known adverse environmental impacts from the intended use or manufacture of Whole Algal Flour. Whole Algal Flour is manufactured in closed Page 5 of 24 fermentation systems that meet EPA and OSHA requirements. Food grade Good Manufacturing Practices (GMP) is in place and we are unaware of any environmental issues associated with the manufacture of this product. d) Effects on human health; The safety of Whole Algal Flour as a food ingredient is supported by publicly available information including, but not limited to, 13-week toxicity, pathogenicity, and genotoxicity studies (Szabo et al., 2012), as well as a human allergenicity trial with Whole Algal Flour (Szabo et al., 2012) and a 28-day repeated dose study on the similarly composed ground yellow high-lipid C. protothecoides biomass (Day et al., 2009; FDA, 2011). e) Effects on soil, organisms, crops, or livestock. Whole Algal Flour is not intended for use on soil, organisms, crops, or livestock. The source organism is not genetically modified or pathogenic. The fermentation is produced under closed systems. 10. Safety information about the substance including a Material Safety Data Sheet (MSDS) and a substance report from the National Institute of Environmental Health Studies. A substance report from the National Institute of Environmental Health Studies does not exist. See Appendix II for a copy of the Material Safety Data Sheet. 11. Research information about the substance which includes comprehensive substance research reviews and research bibliographies, including reviews and bibliographies which present contrasting positions to those presented by the petitioner in supporting the substance’s inclusion on or removal from the National List. For petitions to include non-organic agricultural substances onto the National List, this information item should include research concerning why the substance should be permitted in the production or handling of an organic product, including the availability of organic alternatives. Commercial availability does not depend upon geographic location or local market conditions. See Appendix III for a list of References. Please note, no references were found on contrasting positions on inclusion of Whole Algal Flour in foods or in organic labeled foods. Whole Algal Flour is a whole food product made from a family of algae long consumed in other cultures globally, but now offered in the US as a new food ingredient. This ingredient is considered GRAS by FDA. FDA has issued a No Questions Letter for Page 6 of 24 Whole Algal Flour (GRN 469) on June 7, 20134. FDA has also issued a No Questions letter to a GRAS Notification for Algal oil made from Chlorella protothecoides (GRN 384)5, the same algal strain used for Whole Algal Flour. Microalgae, such as Chlorella spp., have been an accepted part of the human diet for hundreds of years, especially among the populations of Asia and sub-Saharan Africa.6 Currently, wild stocks of various microalgae are harvested as food sources not only in Asia (e.g., China, Japan, Burma, Thailand, India, Mongolia, and Siberia), but also in Central and South America (e.g., Mexico, Bolivia, Ecuador, and Peru), Pacific island nations such as Fiji and Hawaii.7 Of the microalgae that are commercially cultured, those most popular in the U.S., include, but are not limited to, the green microalgae Chlorella spp. and Scenedesmus spp., and the cyanobacteria Spirulina spp. and Aphanizomenon flos-aquae spp.8 In the early 1970s, U.S. companies cultivating microalgae for human and animal use included Earthrise Farms9 in California, Cell Tech10 in Oregon and Cyanotech Corporation11 in Washington12. Internationally, Sun Chlorella13 in Japan and SOSA Texcoco/Spirulina Mexicana14 in Mexico also grew microalgae during this same period. 15 Consumption is not as high in the U.S. as it is among the major consuming populations of China, Korea, and Japan, Chlorella spp. are still widely available in U.S. markets as dietary supplements16. At least twelve different brands of chlorella products are available in forms that include powder, tablet and capsule with recommended dosages ranging from 200 mg up to 10 g/day17. National retailers Vitamin Shoppe18 and GNC19 both carry chlorella products. 4 <http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm361155.htm>; site accessed June 17, 2013 5 <http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm308520.htm>; site accessed June 17, 2013 6 (Kay, 1991; Ravishankar et al., 2006). 7 (Kay, 1991). 8 (Kay, 1991). 9 <http://www.earthrise.com/farm.html>; site accessed February 1, 2012. 10 Currently SimpleXity Health, Inc. (<http://www.simplexityhealth.com>; site accessed February 1, 2012). 11 <http://www.cyanotech.com>; site accessed February 1, 2012). 12 (Kay, 1991). 13 <http://www.sunchlorella.com>; site accessed February 1, 2012. 14 The world’s first large plant for processing microalgae (Spirulina spp.) was built on Lake Texacoco in the 1970s. Although Mexican Spirulina was first imported into the U.S. for use in health food products in 1979, in 1982 importation was blocked by U.S. authorities due to quality concerns related to pollution of the lake system. In addition to health food products, Spirulina was also used in animal and aquaculture feeds. Spirulina Mexicana has been closed for several years (<http://www.spirulinasource.com/earthfoodch6c.html>; site accessed February 1, 2012). 15 (Kay, 1991). 16 (Day et al., 2009) 17 (Hendler and D. Rorvik,2008; FDA, 2011) 18 <http://www.vitaminshoppe.com>; site accessed February 1, 2012. 19 <http://www.gnc.com>; site accessed February 1, 2012. Page 7 of 24 12. A ‘‘Petition Justification Statement’’ which provides justification for any of the following actions requested in the petition: G. Inclusion of a Non-Organically Produced Agricultural Substance Onto the National List, § 205.606 Provide a comparative description on why the non-organic form of the substance is necessary for use in organic handling. Solazyme, Inc. is unaware of any commercially available, organic-certified ingredient that can be a partial replacement for dietary fat. Whole Algal Flour is a high lipid (40- 70% fat) algal flour composed of the dried biomass of the microalgae Chlorella protothecoides. Unlike many other synthetic and non-synthetic ingredients, no GMOs, chemical modification or solvents are used in the production process. Whole Algal Flour will be used as partial replacement for cream, milk, eggs/egg yolks, and/or butter/shortening in baked goods, beverages, dairy and egg products, sauces, gravies, margarines, salad dressings, and soups. It can improve organic product nutrition without taste or texture compromise. It can be used to reduce fat in finished goods or used in smaller quantities to add indulgence or mouthfeel. Organic product producers can simplify their ingredient use and labeling with a better ingredient. Many companies use a combination of starch, gums, hydrocolloids, and fiber to try and achieve lower fat or more indulgent products. Whole Algal Flour can achieve this in one multi-component food ingredient, and create better mouthfeel without increasing viscosity. Unhealthy fats can be reduced by use of this whole food alternative. There are no other solutions that match the functional and nutritional benefits of Whole Algal Flour in one ingredient. To achieve the same result as Whole Algal Flour, organic producers would have to use more non-synthetic or synthetic ingredients in their products. Whole Algal Flour also has the benefit of reducing the fat content in organic products without compromising taste or texture. Whole Algal Flour is a vegan, natural, non-GMO, and gluten free product. Whole Algal Flour is a whole food and therefore no solvents are used or byproducts wasted. It is sustainably produced in food grade cGMP fermentation process with the ability to use a variety of simple sugar sources (corn, sugarcane, etc.) to create a higher order food ingredient. No sewage sludge or ionizing radiation is used in the production process. Whole Algal Flour provides an alternative to eggs, butter and other such ingredients that may be allergens to some Organic customers, and not suitable for others, such as strict Vegans. It also allows for lower fat content without sacrificing flavor, texture, and other important attributes. Provide current and historical industry information/research/evidence that explains how or why the substance cannot be obtained organically in the appropriate form, appropriate quality, and appropriate quantity to fulfill an essential function in a system of organic handling. Page 8 of 24 According to Quality Assurance International (QAI), an organic certifying body, there are 57 Chlorella products (6 processors and 4 distributors) that have been certified organic. 20 However, these Chlorella products are dietary supplements and are not of the same composition, form or quality of Whole Algal Flour. Appropriate form The algal strain used in Whole Algal Flour is Chlorella protothecoides. We could not find any organic certified Chlorella protothecoides derived products. The algal strains used in Organic-certified Chlorella products and other (non-organic) commercially available Chlorella products are Chlorella pyrenoidosa21,22 and Chlorella vulgaris23,24. The products made from these species will have different compositions of lipids and triglycerides (TAG) and therefore are not a suitable replacement for making Whole Algal Flour. A comparison of the lipid and TAG content from the different organisms are described in a paper by A. Assmann, et. al., titled, “The Potential for Micro-Algae and other ‘Micro-Crops’ to produce Sustainable Biofuels”25 and include in Table 2, below. While this paper is about emerging technologies for producing biofuels, the same yield information is applicable. We could not find evidence of organically, or even non- organically, produced Chlorella protothecoides used as a food/food additive or dietary supplement product. 20 <http://www.qai-inc.com/listings/listings_results.asp?KeyWords=chlorella&SearchType=QUICK&ShowCompany=N>; site accessed June 17, 2013 21 <http://www.starwest-botanicals.com/organic-chlorella_powder.html>; site accessed June 17, 2013 22 <http://www.sunchlorella.com/product-info/whats-chlorella.html>; site accessed June 17, 2013 23 <http://www.npnutra.com/chlorella_details.html>; site accessed June 17, 2013 24 <http://www.algomed.de/index.php?op=produkte>; site accessed June 17, 2013 25 < http://deepblue.lib.umich.edu/bitstream/2027.42/83511/1/April%2018%20Final%20Draft.pdf>; site accessed June 17, 2013 Page 9 of 24 Table 2: System specification from A. Assmann, et. al., page 16 Page 10 of 24