Introduction of Fortified Rice Using the Ultra Rice Technology Frequently Asked Questions Updated September 2007 What is Ultra Rice? The Ultra Rice 1 micronutrient delivery system employs a unique mechanism for incorporating vitamins and minerals within an extruded rice grain made from rice flour to minimize nutrient losses. These fortified extruded grains (called Ultra Rice grains ) resemble natural milled rice in size, shape, and density. After drying, Ultra Rice grains are blended with local rice, typically in a ratio of 1:100. When cooked, the fortified rice has the same taste, color, and texture as unfortified rice. All ingredients in the Ultra Rice grains are compliant with international regulatory standards, are vegetarian, and include no genetically modified substances. Ultra Rice has been intensively studied to ensure it is efficacious, shelf-stable, and acceptable to consumers. Health issues What harm does micronutrient malnutrition do in society? Billions of people in the world today suffer from micronutrient malnutrition a factor that substantially contributes to the global burden of disease. The debilitating effects of vitamin and mineral deficiencies are a major impediment to a population s socioeconomic progress. Annually, vitamin A deficiency contributes to the deaths of 2 to 3 million children; iron deficiency saps the energy and active learning capacity of a billion people; lack of folic acid during the first days of pregnancy causes over 200,000 severe birth defects; zinc deficiency affects the growth and immune system functioning of hundreds of millions, in particular leading to longer and more severe bouts of diarrhea in children; and thiamin deficiency quietly continues to affect populations primarily consuming diets of polished rice. How can Ultra Rice help overcome those problems? The Ultra Rice technology provides a relatively simple method for adding nutrients to rice at levels that will prevent micronutrient deficiency diseases from developing. Consumers may not even know that their rice has been fortified, but they obtain the benefits anyway. These nutrients are added to the rice in such a way that the essential vitamins and minerals are protected from loss caused by storage, rinsing before preparation, and cooking. 1 Ultra Rice is a registered trademark in the United States of Bon Dente International, Inc.
What research has been done on Ultra Rice? Over 25 studies have been done on consumer acceptance, shelf life, impact on nutritional status of consumers, and other issues. In trials in Brazil and Nepal, Ultra Rice was shown to improve the vitamin A status of preschool children and pregnant women, respectively. In Mexico, a randomized, placebo-controlled clinical trial found that nonpregnant women who consumed Ultra Rice once a day at their workplace had an 80 percent reduction in anemia. Emerging data from other trials will be added on an ongoing basis to the summary of research conducted on the Ultra Rice technology, which is posted on PATH s website at http://www.path.org/publications/details.php?i=1153. Are all the nutrients added safe? Yes, all the ingredients used in Ultra Rice are Codex Alimentarius compliant. They are all vegetarian and contain no genetically modified ingredients. The nutrient levels in Ultra Rice are many times less than the established tolerable upper limits for consumption, even if someone ate nothing but fortified rice (which of course is NOT a healthy, balanced diet!). Unblended Ultra Rice grains are generally not provided directly to the consumer, but only to rice millers. PATH is confident that responsible blenders will strive to maintain rigorous control over both their quality and inventory programs. Proper manufacturing and blending procedures are part of quality control and analysis, and are included in our standard operating procedures. Manufacturing quality is a key area over which PATH maintains some degree of control. If and when unblended Ultra Rice grains are sold directly to consumers, packaging will need to instruct them on how to store and use the Ultra Rice, exactly as would be done with iron tablets, for example. Ultra Rice grains appear similar to natural rice and are often difficult to find when blended. However, they are not identical in appearance to natural rice, and this would be more obvious if by mistake an adult or older child (capable of cooking it) came across unblended Ultra Rice grains. The only nutrients that could cause any side effects even if consumed at high levels are vitamin A and iron. Vitamin A. Levels of vitamin A typically carried in the Ultra Rice grains range between 500 and 3,000 IU/g, depending upon the objective of a fortification program. Thus, consumption of an unlikely large amount more than 1.5 kg. of cooked, fortified rice would be required to approach the World Health Organization s conservative safe upper limit for pregnant women of 25,000 IU for a single day for a pregnant woman. No one else, even infants, could be harmed by 2
consuming even twice this amount of vitamin A in food in a single day. Iron. The tolerable upper limit for iron intake has been set at 45 mg/day, and the LOAEL 2 70 mg/day. 3 Levels of iron typically carried in the Ultra Rice grains range from 5 to 15mg/g. Thus, even at the upper end, consumption of about 700g. of cooked fortified rice would be required to exceed LOAEL levels. However, true acute toxicity is normally only seen through the ingestion of large quantities of iron through supplements (pills), 4 and it is not known how much would have to be consumed in food to cause serious symptoms (since absorption is slower and reduced). The levels that produce symptoms from supplements (20 to 60 mg. iron per kg. body weight) could be achieved only if a 20-kg. child were inappropriately fed Ultra Rice grains rather than fortified rice and ate over 800 grams of it, which is highly unlikely. For an adult a much larger amount than this would be needed. Other advantages of Ultra Rice What are the advantages of the Ultra Rice technology? The price premium of a fortified rice product (Ultra Rice grains blended with regular local rice) as compared to traditional rice is only marginally higher (2 to 6 percent). This is because existing equipment can be modified to accommodate the relatively simple Ultra Rice technology and the ratio of Ultra Rice grains to traditional rice can usually be 1:100 or less. The nutritional benefits consumers receive from fortified rice greatly outweigh the small increment in price. Growing interest in fortification is leading many governments to mandate fortification of staple foods with iron and folic acid. Until Ultra Rice was developed, this was not possible in places where consumers rinse their rice before cooking it. In the coming years, there may be a push by governments to mandate rice fortification in addition to other staple foods, making early adoption of the Ultra Rice technology advantageous for companies willing to invest. The Philippines has already adopted mandatory rice fortification and many other governments are considering requiring that the food they purchase for social programs be fortified as well. What are the technical advantages of the Ultra Rice technology? The Ultra Rice technology seals nutrients into extruded grains that look and taste nearly identical to natural rice. This keeps nutrient losses minimal during transit, storage, food preparation, and cooking. This helps ensure that label claims regarding nutrient content are met and consumers get maximum benefit from consumption of rice fortified using the Ultra Rice technology. It should be noted that cooking fortified rice in excess water which is not consumed could lead to high nutrient losses no matter what fortification technology is used. 2 LOAEL (the lowest intake or dose at which an adverse effect has been demonstrated) is a level that should not be considered safe for everyone and may require the application of a safety factor to calculate safe intake. 3 Driskell JA, Univ of Nebraska. http://www.ianrpubs.unl.edu/epublic/pages/publicationd.jsp?publicationid=295 accessed Oct 19, 2007. 4 McGuigan MA. Acute iron poisoning. Pediatr Ann. 1996;25(1):33-8. 3
PATH s role What kind of assistance can PATH provide to commercial partners who want to manufacture Ultra Rice? Working within the appropriate local regulatory framework, PATH will provide advice and assistance in selecting an acceptable product formula, product registration (if required), ingredient ordering procedures, design and set-up of a production facility, developing a production regimen and quality control procedures, and creating a unique set of manufacturing standard operating procedures. Currently PATH has donor funds available to provide this kind of support in four countries: China, India, Brazil, and Colombia. Will PATH pay for marketing activities? PATH will not support costs associated with the commercial marketing of this product. However, we remain very interested in the social marketing component and would consider some support of activities that will strengthen this endeavor. Will PATH grant license exclusivity? PATH s past licensing agreements have involved the transfer of production rights for the Ultra Rice technology to commercial partners through a royalty-free license for a specified amount of time. In some cases limited and temporary exclusivity is provided, with nonexclusive rights to sell in most other markets the producer chooses. Ingredients Can all ingredients be purchased locally? Commercial partners are encouraged to purchase ingredients locally to the extent possible, although they must meet the specifications established by PATH. Ingredients that are not manufactured locally or that must be imported are, however, typically available through local suppliers. Shelf life What is the shelf life of the Ultra Rice grains? What is the shelf life of the fortified rice blend? As with all fortified food products, degradation of micronutrients is a concern. PATH recommends that the Ultra Rice grains be blended with rice locally just prior to reaching end consumers. The Ultra Rice grains should not be blended with rice that will subsequently sit in the warehouse for a long period of time before packaging. Given an estimated turnover for commercially packaged rice of 2 to 3 months, PATH has developed a product which will meet label claims for 6 months. PATH will work with its partners to develop formulations that will ensure a longer shelf life upon request. Where practical, the shelf life can be extended by cooling or even freezing the Ultra Rice grains until they are blended with regular rice and packaged. 4
Does special packaging exist that will prolong shelf life? It is our experience that premium packaging may be unaffordable and is not absolutely necessary. PATH will work with the collaborator and its suppliers to select optimal packaging. Certain vitamins are affected by exposure to light and others are oxidized by environmental factors such as heat and humidity; hence any packaging that shields the fortified rice from these factors would be helpful. Simple LLDPE (linear low-density polyethylene) or HDPE (highdensity polyethylene) packaging has sufficient barrier properties to protect Ultra Rice from deterioration. For packaging large quantities of Ultra Rice at minimal cost, simple jute packing material lined with LLDPE would suffice. Rapid inventory turnover may be the most effective way of meeting label claim. What is the shelf life of bags of the dry-mixed component? Unprotected dry mix for vitamin A has a short shelf life. Production should be planned so that it is used within days of being prepared. Ultra Rice grains What factors determine the concentration of micronutrients in the Ultra Rice grains? The formulation takes into consideration the following four factors when determining micronutrient concentrations: Targeted percentage of local recommended dietary intake. Typical rice serving size and expected daily consumption. Planned ratio of Ultra Rice grains to regular rice according to the needs of the target population. Most practical micronutrient density in the Ultra Rice grains (because there is a limit to the amount of micronutrient that can be put into a manufactured rice grain). Is there a difference between weight and bulk density of the Ultra Rice grains? Bulk density is a measure of the weight of Ultra Rice grains needed to fill a specified volume and is a figure used in dosification calculations. Absolute density of a dry extruded grain is important in that it must be greater than water or the grain will float. If they were much lighter in density than rice, the manufactured grains would separate out easily. In fact, the closer the density of the Ultra Rice grains can be to that of natural rice, the less settling will occur during transport of the fortified rice blend. The density of the Ultra Rice grains is controlled through proper manufacturing parameters. How hard are the Ultra Rice grains? The Ultra Rice grains should have physical properties quite similar to those of milled white rice. The grains should be able to withstand a few minutes of soaking, or multiple washings. The PATH team will work closely with technology recipients to ensure that operating conditions are adjusted appropriately. 5
What is the caloric value of the Ultra Rice grains? Analysis of the Ultra Rice grains indicates that 100 g. of vitamin A fortified Ultra Rice grains would provide 366 calories compared to 358 calories for natural rice. The multi-micronutrient grain would be similar. Thus, Ultra Rice provided at a ratio of 1:100 adds only a tiny fraction of a single calorie per 100-g. serving of fortified rice. Can fortified rice using the Ultra Rice technology act as a substitute for fortified products already included in ongoing feeding programs? Most vitamins and minerals need to be consumed on a daily basis for the human body to function efficiently. At present, in many countries worldwide, there are a variety of interventions to increase the intake of micronutrients. It is always important to consider all possible sources of micronutrient delivery when implementing a new program. The goal is to ensure that the minimum physiological needs are met in the most cost-effective manner, while avoiding the rare circumstances when excess consumption could be harmful. In most populations, multiple staple foods are consumed, but the total amount of calories from staple foods tends to remain constant. Thus, fortifying all staple foods at a similar and reasonable level will ensure that a rather constant level of each nutrient included is obtained each day by most of the population. Once this is achieved, it is possible that fortification of condiments, for example, will no longer be needed and could possibly be discontinued to save money. How is iron fortification achieved? Micronized ferric pyrophosphate performs best for rice fortification. Different types are available. Micronized and encapsulated varieties have the highest bioavailability but are much more expensive. PATH recommends the use of ferric pyrophosphate compounds having 24 to 26 percent iron, with an average particle size of 3 microns. Why is ferric pyrophosphate used in making the Ultra Rice grains instead of other iron compounds? Ferric pyrophosphate is now manufactured with such small particle size (and thus high surface area) that it has better bioavailability than most nonsoluble forms of iron. Soluble iron salts impart grayish or brownish coloring to the Ultra Rice grains, but ferric pyrophosphate imparts little if any color. Certain other iron salts also convey a slight taste that some consumers do not like, whereas ferric pyrophosphate has no taste. Production and micronutrient losses What is the overall production loss? Production losses (yield losses) are on average 2 to 3 percent, which are typical for a pasta extruding operation. 6
What are the main causes of micronutrient losses? The reasons for and degree of micronutrient losses vary. Degradation can be caused in varying degrees by contact with ultraviolet light, oxygen, temperature, and humidity, but will vary according to the type of nutrient, the compounds added to the Ultra Rice grains, and the interaction of various nutrients with each other as well with the environment. How are these micronutrient losses handled? Micronutrient losses are minimal in the Ultra Rice production process and are compensated for by adding appropriate overages. PATH will work with each commercial partner to decide on the optimal micronutrient overages needed based on processing, environmental, and food preparation conditions. Manufacturing process What steps are involved in the Ultra Rice production process? The commercial manufacturing process for producing the Ultra Rice grains is separated into two major steps: (1) a batching step, where dry ingredients are weighed and blended with the rice flour carrier, and (2) a dough-making step, where this dry-blend is accurately combined with an oil blend and with water. The first step is not continuous and can be performed at a location remote from the dough-making step as long as transport and storage times are not longer than a few days. Where large-volume production is needed, both steps can be carried out on a continuous basis. Just prior to extruding, the three major components (dry-blend, oil-blend, and water) are accurately metered and combined. The oil phase is pre-blended in a steam kettle to melt the fatsoluble antioxidants included in the formulation. At this step, component metering is critical because the total component flow rate must be varied as the extruder is started and balanced, while the ratio of the three components (dry-blend, oilblend, and water) remains constant. Metering devices are optimized for each component. The dough is extruded at about 35 percent moisture through a rice-grain shaped die, cut with a rotary knife, and passed through a pre-dryer where surface moisture is removed. The still-moist, but separated, extruded grains are passed through a rotating spray-drum, where a solution of calcium chloride is sprayed on the grains surface. This salt serves as a gelling agent when it reacts with a sodium alginate binder included in the dry-blend. This forms a structure that, after drying, will not dissolve into starch when it is placed in water. The drying process needs to be gradual, passing through two additional drying units, until the moisture level is equalized at about 12 percent moisture. What are the relative responsibilities of the rice mill and the extruder? The relative responsibilities depend on the agreements made between the technology recipient and its subcontractor. The rice mill may control most of the process including purchasing and 7
storing raw ingredients, fabricating the dry-blend and oil blends, establishing an extrusion schedule, managing quality control, bagging the dry extruded grains, and finally blending Ultra Rice grains with rice at the point of consumer packaging. The rice miller may subcontract a pasta manufacturer and agree that the latter maintains a greater amount of responsibility for extrusion scheduling and quality control. What quality control measures are used? Quality control measures developed locally for operations specific to each setting will include: Ingredient specifications and ordering procedures. Proper and calibrated scales and check weights for ingredient measurement. Proper and controlled component and ingredient inventory storage. Mixing and batch records. In-process metering accuracy and calibration. Sampling for moisture determinations. Analysis for micronutrient concentrations. Sanitation and hygiene. What specific equipment will be needed? Major equipment needed for manufacturing the Ultra Rice grains that is not part of a typical extrusion set-up would include: Precise weighing and dry-blending equipment. Steam-jacketed oil-blending and metering equipment. Dry-blend metering equipment. Rotating spray-drum and metering pump and holding tank for calcium salt solution application. A blending/mixing system to ensure that the required blend ratio of Ultra Rice grains to rice is maintained at or before the final packing operation. Where can the needed equipment be found? All necessary equipment components should be available locally in most countries. Off-the-shelf items may be more expensive than similar systems fabricated locally. PATH s technical staff will work with commercial partners on appropriate and economical equipment procurement. What capital investment is required to use the Ultra Rice technology? Depending upon the proportion of new, leased, and locally fabricated equipment employed, and the capacity needed, a total capital investment of US$50,000 to $300,000 can be anticipated. 8
Export of Ultra Rice Could our company export Ultra Rice? The terms of the license agreement can include permission to export to markets identified in advance by the commercial partner. Advocacy and commercialization What has PATH achieved in its advocacy and commercialization efforts for rice fortification using the Ultra Rice technology? Activities and achievements in China, India, Brazil, and Colombia are recorded in PATH s informational brochure on Ultra Rice, at http://www.path.org/publications/details.php?i=1182, available in Portuguese, Spanish, and Chinese as well as English. What can PATH contribute to the advocacy and commercialization of Ultra Rice technology? For nearly 30 years, PATH has developed, adapted, transferred, and introduced technologies that improve global health. In order to achieve this, PATH communicates with and actively collaborates with relevant stakeholders, government regulatory bodies, and target populations to increase understanding of the importance of its efforts. For Ultra Rice, PATH advocates about the benefits of fortified rice with local and international public-sector decision makers. In addition, PATH is working to develop an evidence base of both research and operational data so that Ultra Rice is accepted as an important vehicle to address malnutrition among riceconsuming populations. For commercialization of Ultra Rice, PATH will provide its technology to interested private parties and will help them to promote the fortified rice to the public sector through government channels. However, for commercial sales, the private partner will have to find means for promotion, as for any product. Could PATH share with its partners the business models in other markets? Since PATH is a nonprofit organization, we would be glad to share our business models with any company that is interested in manufacturing fortified rice using the Ultra Rice technology. Questions for consumers How does Ultra Rice affect the taste and smell of the regular rice? Ultra Rice does not affect the taste or smell of normal rice. There is one grain of Ultra Rice to every 99 or more grains of normal rice; in fact, you would not be able to easily distinguish the Ultra Rice grain, particularly after the fortified rice is cooked. Will there be any change in the color and the final cooked rice? 9
No, there will be no color change imparted to the cooked rice. Is it OK if we use the Ultra Rice for cooking other recipes? Can the same rice be used to make rice flour? Rice fortified using the Ultra Rice technology can be easily used to cook other recipes, as long as the water used to soak the rice is not thrown out and all of the cooking water is absorbed into the rice. This will help retain the nutrients. It is not recommended that Ultra Rice be made into rice flour unless it is immediately consumed, since this would eliminate the protective matrix which the manufactured rice grains provide to the nutrients. For more information on the Ultra Rice project, please contact: Dipika Matthias, Project Director PATH 1455 NW Leary Way Seattle, WA 98107 USA Phone: 206-285-3500 Email: dmatthias@path.org Please visit www.path.org. 10