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CFNP TAP Report for Urea January 2004 SUMMARY of TAP

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CFNP TAP Report for Urea January 2004 SUMMARY of TAP CFNP TAP Report for Urea January 2004 SUMMARY OF TAP REVIEWERS’ ANALYSES1 Urea is being petitioned for use as an insect (fruit fly) attractant in sticky traps in order to prevent extensive damage to olive and fruit crops. Urea slowly and progressively breaks down to ammonia and carbon dioxide inside the sticky traps. Ammonia is a volatile compound that lures fruit flies into the sticky traps. The size and placement of the openings leading into the sticky traps are designed to favor the trapping of fruit flies with minimal trapping of other insects. Ammonium carbonate, a substance already approved for use as bait in insect traps, also breaks down to produce ammonia over an extended period of time. The petitioner is requesting that urea be permitted on the National List of synthetic substances allowed for use in organic crop production since its mode of action is similar to that of ammonium carbonate. All three reviewers concluded that urea, as petitioned, is a synthetic substance. Two of the reviewers recommended, without hesitation, that urea should be included on the National List. The other reviewer had concerns about allowing urea on the National List since it has not historically been allowed for use in organic crop production and since other acceptable substances are available for insect control. However, this reviewer also recommended that urea be allowed on the National List since it will only be used as an insect attractant in sticky traps. Synthetic or Non-synthetic? Allow without restrictions? Allow only with restrictions? (See reviewers’ comments for restrictions) Synthetic (3) Yes (3) Yes (0) Non-synthetic (0) No (0) No(0) IDENTIFICATION Common Name: Urea CAS Registry Number: 57-13-6 1 This Technical Advisory Panel (TAP) report was based upon the information available at the time this report was generated. This report addressed the requirements of the Organic Foods Production Act of 1990, as amended, to the best of the investigator’s ability and was reviewed by experts on the petitioned substance. The substance was evaluated according to the criteria found in Section 2119 of the OFPA [7 U.S.C. 6518(m)(1-7)]. Any recommendation(s) presented to the National Organic Standards Board (NOSB) was based on the information contained within the TAP report and the evaluation of that information relative to these criteria. The TAP report does not incorporate commercial availability, socioeconomic impact, or other factors related to the petitioned substance, which NOSB and USDA may want to consider in their decision process. CFNP TAP Report for Urea January 2004 Other Names: Carbamide; Carbamimidic Acid; Carbonyldiamide; Carbonyl Diamine; Isourea; Pseudourea; Ureaphil; Ureophil; Urevert; Urepearl; Urea Perhydrate; Varioform II; Nimin; Benural 70; UR; Urea-13C; Aquacare HP; Aquadrate; Alphadrate; Nutriplus; B-I-K; Urecare; Urederm; Calmurid; Carbaderm; Keratinamin; Pastaron; Prespersion, 75 Urea; Ultra Mide; Mocovina; Supercel 3000; Aqua Care; Harnstoff; Basodexan; Bubber Shet; Elaqua XX; Hyanit; Onychomal; Panafil; Superprill; NCI-C02119; component of Artra Ashy Skin Cream CHARACTERIZATION Composition: White, odorless crystalline powder Properties: Molecular Formula: CH4N2O or CO(NH2)2 Molecular Weight: 60.06 Melting Point: 133oC Boiling Point: Not Applicable Density: 1.34 g/cm3 Water Solubility: 1080 g/L at 20oC PRODUCTION Urea is mainly produced for use in fertilizer mixtures. A small amount of urea is produced for use in animal supplements. Urea is also used in the manufacture of dyes, fire-retardant paints, plastisizers, and explosive stabilizers. The urea manufacturing process involves seven core unit operations. These operations include solution synthesis, solution concentration, solids formation, solids cooling, solids screening, solids coating and bagging, and/or bulk shipping. Urea solution production plants use only bulk shipping and solution formulation operations. Solid urea production involves a combination of all unit operations. In the urea solution synthesis process, carbon dioxide and ammonia react to form ammonium carbamate. This reaction is shown in equation one: 2NH3 + CO2 → NH2CO2NH4 (1) Ammonium carbamate is later dehydrated to yield a 70-77 percent aqueous urea solution. This reaction is shown in equation two: NH2CO2NH4 → NH2CONH2 + H2O (2) Typical reaction conditions for equation one are temperatures ranging from 180-200 degrees Celsius and pressures ranging from 140-250 atmospheres. Vacuum concentration, crystallization, and atmospheric evaporation are the three primary methods of concentrating urea solutions, with atmospheric evaporation being the most common method [EPA, 1995]. CFNP TAP Report for Urea January 2004 HISTORY OF USE Non-Organic Growers: H. M. Rouelle first discovered urea in human urine in 1773. Friedrich Wohler first synthesized urea in 1828, making it the first organic compound that was synthesized from inorganic starting materials. Urea production began in 1870 by heating ammonium carbamate in a sealed vessel. This process led to urea’s current industrial production process. Urea has been used in conventional (non-organic) agriculture as a frost protectant and fertilizer for crops as well as an animal feed supplement. Organic Growers: Urea is not currently included as an approved synthetic substance for organic production and handling on the National List of Allowed and Prohibited Substances (National List). However, ammonium carbonate has been approved for the same use that the current petitioner requests for urea. According to § 205.601 Synthetic substances allowed for use in organic crop production of the National List: “(e) As insecticides (including acaricides or mite control) (1) Ammonium carbonate - for use as bait in insect traps only, no direct contact with crop or soil” CURRENT STATUS U.S. Regulatory Agencies: FDA: In 1983, urea was affirmed generally recognized as safe (GRAS) as a food ingredient by the Food and Drug Administration. According to the Code of Federal Regulations (21 CFR Part 184), revised April 1, 2003: § 184.1923 Urea. (a) Urea [CO(NH2)2, CAS Reg. No. 57-13-6] is the diamide of carbonic acid and is also known as carbamide. It is a white, odorless solid and is commonly produced from CO2 by ammonolysis or from cyanamide by hydrolysis. (b) FDA is developing food-grade specifications for urea in cooperation with the National Academy of Sciences. In the interim, this ingredient must be of a purity suitable for its intended use. (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use: (1) The ingredient is used as a formulation aid as defined in Sec. 170.3(o)(14) of this chapter and as a fermentation aid. CFNP TAP Report for Urea January 2004 (2) The ingredient is used in yeast-raised bakery products; in alcoholic beverages as defined in Sec. 170.3(n)(2) of this chapter; and in gelatin products. (d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived [DHHS, 2003]. EPA: EPA first registered urea in 1995 as a frost protectant pesticide under the trade name of Enfrost. Enfrost, 43% liquid urea, is applied commercially to field crops, vegetables, and fruit trees in an effort to reduce frost damage. In 1995, EPA established a permanent exemption for urea from residue tolerance requirements when used as a frost protectant on agricultural commodities (40 CFR Part 180, §180.1117). EPA’s decision resulted from various studies showing that urea has a low toxicity to animals by oral, dermal, and inhalation routes of exposure. EPA’s exemption decision is only for urea when it is applied as a pesticide [Daiss, 2001]. OSHA: Urea is considered to be hazardous as defined by the OSHA Hazard Communication Standard. OSHA has established the following Permissible Exposure Limits (PELs) for urea: 1) 15 mg/m3 TWA (total) (7), and 2) 5 mg/m3 TWA (respirable), where TWA = 8-hour Time-weighted Average. Other U.S. Sources: The Washington State Department of Agriculture (WSDA) does not approve urea as an approved substance in organic crop production [WSDA]. All states that are accredited organic certifiers are in compliance with the NOP guidelines.2 Status Among International Certifiers: European Union: Urea is not listed on the approved list of additives currently permitted in the European Union. World Health Organization: WHO has listed urea as “obsolete” (discontinued) for pesticide use [Orme 2003]. Canada: According to the Canadian Environmental Protection Act (CEPA), urea is on the Domestic Substances List (DSL) and is acceptable for use under the provisions of CEPA. 2 Phone interview on January 9, 2004 with Meg Moynihan, Agriculture Diversification Specialist at the Minnesota Department of Agriculture. CFNP TAP Report for Urea January 2004 APPLICATION Urea can be applied to crops in either solid or solution form. It can also be used as a foliar spray. Urea is being petitioned for use as an insect attractant in organic crop production. The urea solution, diluted with water from 20% urea down to 5% urea, is not applied directly to crops or soil. The 5% urea solution, when applied to sticky traps, works by luring fruit flies (Bactrocera oleae and Ceratitis capitata) to the sticky traps in order to prevent crop destruction. INCOMPATIBILITIES Urea must
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