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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 1 OF 19 181500RFEB2010 US Army Environmental Command EPA 25(b) Exempt Pesticides Zia Mehr Acting Chief, Conservation Branch 11 February 2010 Our MissionLead and execute environmental programs and provide expertise that enables Army training, operations, acquisition and sustainable military communities. Our Mission: Lead and execute environmental programs and provide expertise that enables Army training, operations, acquisition and sustainable military communities. ENABLING MISSION READINESS
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 2 OF 19 181500RFEB2010 US Army Environmental Command FIFRA requires that all pesticides must be registered with the EPA before they can legally be sold or used in the U.S. In 1996, EPA exempted certain pesticides, considered to pose minimum risk to humans and the environment, from this requirement, provided the products satisfy certain conditions [40 CFR section 152.25(g)]. – reduce cost associated with registration – focus on non-exempt products BACKGROUND
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 3 OF 19 181500RFEB2010 US Army Environmental Command EPA 25(b) exempt products do not require: EPA label approval EPA data review EPA Registration Numbers or Establishment Numbers Signal Word PPE requirement EXEMPT PRODUCT REQUIREMENTS
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 4 OF 19 181500RFEB2010 Criteria 1: Only those active ingredients (31) that are listed by the EPA. Active ingredients may NOT be used as Inert Ingredients. CONDITIONS FOR EXEMPTION Castor Oil (U.S.P. or equivalent) Cedar Oil Cinnamon* and Cinnamon Oil* Citric Acid* Citronella and Citronella Oil Cloves* and Clove Oil* Corn Gluten Meal* Corn Oil* Cottonseed Oil* US Army Environmental Command
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 5 OF 19 181500RFEB2010 US Army Environmental Command Criteria 1: Only those active ingredients that are listed by the EPA. Peppermint* and Peppermint Oil* 2-Phenethyl Propionate (2-phenylethyl propionate) Potassium Sorbate Putrescent Whole Egg Solids Rosemary* and Rosemary Oil* Sesame* and Sesame Oil* Sodium Chloride (common salt)* Sodium Lauryl Sulfate* CONDITIONS FOR EXEMPTION
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 6 OF 19 181500RFEB2010 US Army Environmental Command Criteria 1: Only those active ingredients that are listed by the EPA. Soybean Oil Thyme* and Thyme Oil* White Pepper* Zinc Metal Strips (consisting solely of zinc metals and impurities) *These active ingredients are exempt for use on all food commodities from the requirement of a tolerance on all raw agricultural commodities at 40 CFR 180.1164(d). CONDITIONS FOR EXEMPTION
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 7 OF 19 181500RFEB2010 US Army Environmental Command Criteria 2: Only those inert ingredients that are listed by the EPA “Inert Ingredients of Minimal Concern” – classified by EPA as 4A (162 products). Inert Ingredients may NOT be used as Active Ingredients. Acetic acid, Agar, Alfalfa, Beef fat, Beeswax, Bone Meal, Bread Crumbs, Calcite, Carbone dioxide, Cardboard, Carrots, Cheese, Citric acid, Cocoa, Coffee grounds, Cookies, Cork, Corn…., Dextrin, Eggs, Flour, Gypsum, Honey, ….Lime, Milk, Nylon, Oatmeal, Olive oil, Peanuts, Potatoes, Rice, Rubber, Sawdust, Sodium, Soybean oil, Vermiculite, Vitamin C, Water, Wheat, Wool, Yeast CONDITIONS FOR EXEMPTION
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 8 OF 19 181500RFEB2010 US Army Environmental Command Criteria #3: Labeling – all ingredients in an exempted product must be listed on the label: Active ingredients must be listed by name and percentage (by weight). All inert ingredients must be listed by name. The product must not make public health claims. The product may not bear any claims to control or mitigate microorganisms in a way that links microorganisms to a threat to human health (bacteria or viruses). CONDITIONS FOR EXEMPTION
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 9 OF 19 181500RFEB2010 US Army Environmental Command Criteria #3: Labeling (continued) - Unacceptable statements: –Controls ticks that can carry Lyme disease. –Controls mosquitoes that may transmit West Nile virus. Acceptable statements: –Controls ticks. –Controls mosquitoes. CONDITIONS FOR EXEMPTION
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 10 OF 19 181500RFEB2010 US Army Environmental Command Criteria #3: Labeling (continued) – The product must not include any false or misleading statements regarding: Product composition Effectiveness Value of the product for a purpose other than use as a pesticide Comparisons with other pesticides CONDITIONS FOR EXEMPTION
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 11 OF 19 181500RFEB2010 US Army Environmental Command Criteria #3: Labeling (continued) – Implying - pesticide/device is recommended or endorsed by any agency or the federal government. Ex – “Recommended by EPA as safe and exempt.” “It is a Violation of Federal Law to Use this Product in a Manner Inconsistent with its Labeling.” “EPA Registration # or EPA Establishment #.” CONDITIONS FOR EXEMPTION
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 12 OF 19 181500RFEB2010 US Army Environmental Command If the product is to be used on food, food crops, food contact surfaces, or animal feed commodities – it must have a tolerance or tolerance exemption under the Federal Food, Drug, and Cosmetic Act (FFDCA). FOOD TOLERANCE
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 13 OF 19 181500RFEB2010 US Army Environmental Command Product label is formatted per EPA guidance; the states may require additional requirements on the label. Each state has its own statutes and regulations concerning pesticide registration and regulation –States are NOT required to permit the sale of a Section 25(b) product simply because it meets EPA’s stated conditions for minimum risk exemption. About 38 states do not recognize this exemption. Example, Washington State - –Signal word, precautionary statement and PPE –Aquatic toxicity is required for products labeled for aquatic use. STATE REGULATIONS
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 14 OF 19 181500RFEB2010 US Army Environmental Command Labeling requirements: Product Name Product Function Ingredient Statement Direction for Use Precautionary Statements – keep out of reach children Storage and Disposal Statement Name & Address of Registrant/Manufacturer Weight or Measure of Contents Optional Information – WA Registration Number WASHINGTON STATE REGULATIONS
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 15 OF 19 181500RFEB2010 US Army Environmental Command 25(b) Exempt Pesticides – Army Army promotes Integrated Pest Management (IPM) and the use of least toxic products. USAEC reviews EPA 25(b) Exempt products thru the same review as registered products. Search for efficacy – very little data available. –Manufacturers (EcoSMART) –Universities (Iowa State, UC Riverside) –Cooperative Extension Services (Cornell, Auburn) Developed summaries based on available 3 rd party research data. ARMY COMPLIANCE
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 16 OF 19 181500RFEB2010 US Army Environmental Command 25(b) Exempt Pesticides – Army Limited use on Army installations Efficacy Report ( source: anonymous, Army installation ) –EcoExempt G 3.5% (Eugenol/Thyme Oil) –EcoExempt HC 42.8% (Phenethyl Propionate/Eugenol) –EcoExempt 1C 10% (Rosemary/Wintergreen/Mineral Oil) –EcoExempt Jet 5%, Wasp & Hornet Killer (Phenethyl Propionate/Eugenol) ARMY COMPLIANCE
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 17 OF 19 181500RFEB2010 US Army Environmental Command 25(b) Exempt Pesticides – Army Efficacy Report ( source: anonymous, Army installation ) –Victor Poison-Free Wasp & Hornet Killer Overall users satisfaction with efficacy Will continue to promote least toxic pesticides including 25(b) exempt products ARMY COMPLIANCE
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 18 OF 19 181500RFEB2010 US Army Environmental Command No toxicity testing of product required - need more scientific data to support efficacy claim. Not all claims have been substantiated. Limited scientific efficacy data – we have to rely on available data and our installations’ experiences. Ingredients are not subject to verification. Distinction between “Active” and “Inert” is arbitrary. Lack of requirements for signal words and PPE implies that safety and exposure minimization are not a concern for these 25(b) products. Some of the listed approved ingredients may be corrosive. COMMENTS
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Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/zia.mehr@us.army.mil 19 OF 19 181500RFEB2010 US Army Environmental Command INSTALLATION MANAGEMENT COMMAND “Sustain, Support and Defend”
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