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EPA 25(b) Exempt Pesticides Zia Mehr Acting Chief, Conservation Branch 11 February 2010

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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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slide1

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

slide2

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
slide3

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
slide4

US Army Environmental Command

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.
  • 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*
slide5

CONDITIONS FOR EXEMPTION

  • 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*
slide6

CONDITIONS FOR EXEMPTION

  • 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) .
slide7

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

slide8

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).
slide9

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.
slide10

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
slide11

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 #.”
slide12

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).

slide13

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.
slide14

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
slide15

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.
slide16

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)
slide17

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
slide18

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.
slide19

INSTALLATION MANAGEMENT COMMAND

“Sustain, Support and Defend”