Federal EPA Pesticide Registration

Pesticide registration with EPA is the central feature of FIFRA’s pesticide regulatory program. With certain exceptions, it is unlawful to sell or distribute a pesticide unless it is first registered with EPA’s Office of Pesticide Programs. EPA separates pesticides into three distinct categories: antimicrobials, biopesticides and conventional chemical pesticides.

Antimicrobial Pesticides
Antimicrobial pesticides are substances or mixtures of substances used to control the growth of microorganisms – bacteria, viruses or fungi – on inanimate objects and surfaces. Non-public health antimicrobials control growth of microorganisms to preserve materials and control microorganisms infectious only to animals.


Public health products are intended to control microorganisms infectious to humans in an inanimate environment and are classified in accordance with their level of control of microorganisms:

▲ Sterilizers are intended to destroy or eliminate all forms of microbial life, including fungi, viruses, bacteria and their spores;

▲ Disinfectants – hospital and general use – are intended for use on hard inanimate surfaces and objects to destroy infectious fungi and bacteria but not necessarily their spores;

Sanitizers reduce, but do not necessarily eliminate, microorganisms from the inanimate environment to levels considered safe and include food contact and non-food contact products; and

Antiseptics and germicides prevent infection and decay by inhibiting the growth of microorganisms. They are regulated by FDA because they are used in or on living humans or animals.

Biopesticides
Biopesticides, which consist of biochemical and microbial pesticides, are products that are natural in origin or functionally similar to natural products that are used to control or mitigate pests through non-toxic mechanisms. Microbial pesticides consist of microorganisms, such as a bacteria, fungi, viruses or protozoans, as the active ingredient. While microbial pesticides can control many different types of pests, each separate active ingredient is relatively specific for its target pest(s). Biochemical pesticides are naturally occurring substances that control pests by non-toxic mechanisms; they include substances such as insect sex pheromones that interfere with mating and various scented plant extracts that attract insect pests to traps. Plant-incorporated-protectants, which are pesticidal substances that plants produce from genetic material that has been added to the plant, are also categorized as biopesticides.

Conventional Chemical Pesticides
While most commonly associated with agriculture use sites, conventional pesticides include many different classes of products, such as herbicides, insecticides, fungicides and rodenticides. Before these new products can be made available they must be rigorously assessed by EPA to ensure that they meet current health, environmental and safety standards. Older pesticides that are already on the market are re-evaluated to ensure that they continue to meet these standards.

Although all three types of pesticides share the same application materials – administrative forms, a product label and scientific data – each category has unique data requirements and review policies. For each category of pesticide, there are three different types of products that can be registered: a technical product, a manufacturing product and an end-use product.

Services


TSG’s consultants have expertise in all aspects of the EPA pesticide registration process and routinely prepare and submit applications for antimicrobial, biopesticide and conventional chemical pesticides. Our regulatory and scientific experts assist companies with:

The preliminary negotiation of data requirements
Designing and monitoring regulatory studies
Preparing risk assessments
Developing product labels
Assembling applications

We have significant experience in:

▲ Product development
Data development 
Data compensation
Good Laboratory Practice (GLP) compliance
Product chemistry
Residue analysis
The interpretation of data results

We also assist in the preparation of:

Data waiver rationales
Human health risk assessments 
Environmental risk assessments
Tolerance petitions
▲ Label amendments
New inert ingredient petitions

TSG’s pesticide experts routinely submit applications to register pesticide products for new active ingredients, major new uses, new formulations, substantially similar “me-too” products and inert ingredients. We also track product applications throughout the registration process and respond to questions that arise during EPA’s review. In addition, our consultants strong working relationships with government officials help provide quick, effective and reliable service.