Enterprises usually have to spend a huge amount of cost to complete a pesticide registration under the US EPA, but are subject to registration amendments afterward due to various reasons, such as trade market demands, formula changes, active ingredient source changes, label changes, etc. What’s the difference between the pesticide registration amendments and new registration? Is the registration amendments easier than new registration? In this article, REACH24H will give a detailed introduction to pesticide registration amendments under the US EPA.

Product chemical data is the most basic part among the pesticide registration dossier. In addition to identity information, it also includes the 5 batch analysis of the technical materials, phys-chem properties and physical hazards for both technical materials and preparations, and technical properties for preparations. Generally, tests are needed to generate data for the four parts. This article will compare the product chemistry requirements for pesticide registration in China, the US and Europe, hoping to help companies in pesticide registration in various countries.  

In the United States, the overarching regulation on pesticide management is the Federal Insecticide, Fungicide, and Rodenticide Act(FIFRA), which specifies the definition of a pesticide as: any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest, or use as a plant regulator, defoliant, or desiccant, as well as any nitrogen stabilizer. On day two of the Chemical Regulatory Annual Conference, Mr. Robert Kiefer from Reach24H USA introduced the regulatory system of pesticide and antimicrobial products in the US. Overview of Requirements for US Pesticide Registration Laws and Regulations All pesticides (including imported pesticide) sold or distributed in the US are required to be registered with the Environmental Protection Agency (EPA).However, if the substance falls under the category of liquid chemical sterilizing agent, nitrogen stabilizer, human drug, animal drug, animal feeds (vitamin hormone products) or is intended to aid the growth of desirable plants, it is excluded from regulation by FIFRA. In addition, pesticides are regulated by the EPA under a series of supporting regulations. The name and EPA’s function under associated regulations are summarized as follow: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) – requires all pesticides sold or distributed in the U.S. (including imported pesticides) to be registered by EPA Federal Food, Drug and Cosmetic Act (FFDCA) – requires EPA to set pesticide residue tolerances for all pesticides used in or on food Food Quality Protection Act of 1996 (FQPA) – established safety criteria of “reasonable certainty of no harm”, and EPA must review pesticide registrations every 15 years Pesticide Registration Improvement Act of 2003 (PRIA) – established pesticide registration fees and defined Agency  timelines Regulations implementing the pesticide statutes a