Re: Pesticide Regulatory Compliance

It is our understanding that;

  1. The Federal Insecticide, Fungicide and Rodenticide Act, commonly referred to as FIFRA, is the federal law that governs the use of pesticides.
  2. The administrative enforcement of the Act are over seen by the Environmental Protection Agency, the EPA.
  3. For the purpose of administration, the EPA has established two categories of pesticide. The first category is defined under Section 25(b) of the Act. Products that fall under this category are not to be registered. The EPA has published two lists. The first is a list of thirty-one (31) elements which it labels as “Active Ingredients.” The second list is of one hundred sixty (160) elements which it labels as “Inactive Ingredients.” Together these elements are commonly termed GRAS, Generally Regarded As Safe.
  4. To qualify for “exemption” from registration, the product’s active ingredient(s) must be composed only of an element or elements from the EPA’s list of 31 and its inactive or inactives must be composed only of an element or elements from the EPA’s list of 160. Any deviation, that is, if the product contains any element not listed as one of the 31 or that is found among the 160, then the product is not exempt and the product must be registered with the EPA. When registered, the product receives a “Registration Number.”
  5. Products that are not registered and that should not be registered as they are regulatorially exempt, received no registration number nor do they receive any form of acknowledgement rom the EPA of any kind. Whereas all manufacturers receive an “Establishment Number” EPA provides that this number shall not be included on the product’s label. EPA feels that reference to the product manufacturer’s “Establishment Number” could be construed to mean that the EPA was in some way passing judgment on the exempt product and it has not.
  6. The EPA does not issue Certificates.
  7. False claims and/or unlawful practices are addressed by the Federal Trade Commission, the FTC and the EPA.
  8. Each state also has the right to regulate the use of pesticides within its own borders to the extent that no state may have a law more liberal than FIFRA, however, a state may promulgate and enforce regulations more stringent.
  9. Neither the EPA nor any state other than New Mexico and Washington require that the manufacturer provide any proof that an unregister 25b product has efficacy.
  10. The FTC has among its tasks the responsibility to prosecuted manufacturers that make false or misleading claims about their product(s). Recent cases also show that the FTC
  1. prosecutes and has won where the defendant manufacturer has not shown a basis for a “good faith belief” as to the efficacy of their product.
  2. About 35 states have regulatory compliance schemes in addition to FIFRA. The additional states have no specific regulations and provide that EPA compliance is all that they require.
  3. Rules for individual states and foreign countries should be consulted for specific requirements. .

The EPA provides for two categories of product: (a) products that must be “registered” and (b)products that do not need to be registered.

The specific regulations as to products that do not need to be “registered” are provided for under FIFRA 25(b). These products are often referred to as “25b” products.

The Regulations and Publications

US Environmental Protection Agency Office of Pesticide Programs Notice 2000-6 – This publication provides at page 9 Appendix A, which it identifies as “Products Exempted under section 25(b) of FIFRA legislation.  You will note that item # 28 on this list is “soybean oil” which is the labeled active ingredient on the product label. There is also attached that explains that the soybean oil is the source of the polypeptide protein molecules which is the active. The molecule has been engineered to re-act only with the chemistry of the waxy outer layer of the bed bug and other morphologically similar insect pests. Because human beings and other mammals do not have waxy outer layers, we are unaffected and cannot be harmed. Likewise, there is no harm that can be done to the environment.

4)  US Environmental Protection Agency publication entitled, “Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products.  – This listing is commonly referred to as the “4A List” of minimal risk ingredients.  You will also note that there are several pages of elements identified by CAS Reg number and Chemical Name.  The products identified on the product label including the preservative are:

1344 – 00 – 9       Aluminum sodium silicate

1344 – 52 – 2       Calcium silicate

12259 – 21 -1      Iron Oxide

1343 – 88 – 0       Magnesium silicate

7778 – 80 – 5       Potassium sulfate

7757 – 82 – 6       Sodium Sulfate and

532 – 32 – 1         Sodium benzoate

The product does not have an EPA registration number as registration is not required for exempt products. The product does have an “establishment number” and this appears on the product label. A copy of the label is attached.

Products that are nontoxic and that are classified as Generally Regarded As Safe (GRAS) are often referred to by the Environmental Protection Agency regulatory provision as “25b” or “25b products.”
This refers to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 25(b). This is such a product.

You will find as attachments to this email several documents which I believe will be helpful to you as you may be called upon to explain the non-toxicity and safety of the product.  Some of those that you speak to may want copies of certain of these documents for their own files so as to affirm their own care and acts of due diligence in determining to use only safe and efficacious products.  You may make copies as you deem appropriate.

1)  The Product Label – Pesticide labels are highly regulated not only to the extent as to what information and statements must and must not appear but also in terms of what order it must appear in.

EPA requires that all active ingredients be listed by percentage of weight.  They have no such requirement as to this information concerning inert or as they prefer, “other” elements.  Three states do.  You will notice that our label lists both active and inactive, “Other”, ingredients by their respective percentage of weight


2) 
Material Safety Data Sheet – This form explains characteristics of the product that might be required if the area in which it was stored or used became involved in a fire or other emergency circumstance or where a person were to come into contact with the product, ingest it, spill it, or should it be exposed to extreme temperatures or fire.

Because bed bugs are not attracted to bait, any insecticide must be taken to them. Where an infestation exists, approximately 60% of the infestation will be in the form of unhatched eggs. These are generally located in well concealed harborages and even with the best methods of application survive. It is for this reason that a residual is necessary. Without it, when the unaffected eggs hatch in 10 to 15 days the re-emergent nymphs begin the active infestation all over again. The residual kills the emerging nymphs on contact as they crawl about the treated areas. These “inert” ingredients have been chosen because they act as porous carriers. They are diffused with the initial application and remain enmeshed in fabrics and textiles. When the nymphs crawl and disturb the particles, the protein reservoired inside them spills out onto the pests’ torso and kills them.

5) Certification Letter of the American Academy of Entomological Science dated February 9, 2009 – This letter serves to provide an external, third party certified opinion delivered by a recognized expert that (a) the elements listed as the elements of our product are exempt actives and exempt inactives as provided for by EPA regulation, (b) that the elements that are label are one and the same with those that are labeled and that there are no others present other than those labeled, and (c) that the product is effective in the elimination and prevention as to those insect pests shown on the product label when the product is used according to label directions.