Transcript Slide 1

US Army Environmental Command
EPA 25(b) Exempt Pesticides
Zia Mehr
Acting Chief, Conservation Branch
11 February 2010
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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BACKGROUND
 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
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EXEMPT PRODUCT REQUIREMENTS
EPA 25(b) exempt products do not require:
 EPA label approval
 EPA data review
 EPA Registration Numbers or Establishment
Numbers
 Signal Word
 PPE requirement
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CONDITIONS FOR EXEMPTION
Criteria 1: Only those active ingredients (31) that
are listed by the EPA.
 Active ingredients may NOT be used as
Inert Ingredients.
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Castor Oil (U.S.P. or equivalent)
Cedar Oil
Cinnamon* and Cinnamon Oil*
Citric Acid*
Citronella and Citronella Oil
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Cloves* and Clove Oil*
Corn Gluten Meal*
Corn Oil*
Cottonseed Oil*
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CONDITIONS FOR EXEMPTION
Criteria 1: Only those active ingredients that are
listed by the EPA.
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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*
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CONDITIONS FOR EXEMPTION
Criteria 1: Only those active ingredients that are
listed by the EPA.
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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) .
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CONDITIONS FOR EXEMPTION
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
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CONDITIONS FOR EXEMPTION
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).
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CONDITIONS FOR EXEMPTION
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.
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CONDITIONS FOR EXEMPTION
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
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CONDITIONS FOR EXEMPTION
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 #.”
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FOOD TOLERANCE
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).
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STATE REGULATIONS
 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.
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WASHINGTON STATE REGULATIONS
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
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ARMY COMPLIANCE
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.
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ARMY COMPLIANCE
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)
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ARMY COMPLIANCE
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
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COMMENTS
 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.
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INSTALLATION MANAGEMENT COMMAND
“Sustain, Support and Defend”
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