Zia Mehr/IMAE-EQ/(401) 436-1213 (DSN 584)/[email protected] 1 OF 19 181500RFEB2010
US Army Environmental Command
EPA 25(b) Exempt Pesticides
Zia MehrActing Chief, Conservation Branch
11 February 2010
Our MissionOur Mission: Lead and execute environmental programs and provide Lead and execute environmental programs and provide expertise that enables Army training, operations, acquisition and expertise that enables Army training, operations, acquisition and sustainable military communities.sustainable military communities.
ENABLING MISSION READINESS
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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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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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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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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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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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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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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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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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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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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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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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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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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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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 3rd party research data.
ARMY COMPLIANCE
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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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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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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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US Army Environmental Command
INSTALLATION MANAGEMENT COMMANDINSTALLATION MANAGEMENT COMMAND
“Sustain, Support and Defend”
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