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 Mehr.

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



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



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

HBOLTON


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*




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*




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) .




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




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).




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.




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




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 #.”




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



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



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



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




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




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



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



INSTALLATION MANAGEMENT COMMANDINSTALLATION MANAGEMENT COMMAND

“Sustain, Support and Defend”

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 Mehr.

Documents

active ingredients

zia mehrimaeeq401

cinnamon oil

corn oil

rosemary oil

sesame oil

thyme oil

peppermint oil