Since the outbreak of COVID-19 at the end of 2019, the U.S. EPA has issued a series of friendly policies to encourage companies to register disinfectants in order to ensure the demands for disinfectants by U.S. citizens. Driven by both market demand and government policies, many Chinese companies took advantage of this opportunity to layout the U.S. disinfectant market.  

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.  

On June 2, the US EPA invited a 15-day consultation on the registration of novel microbial nematicide Purpureocillium Lilacinum Strain PL11, including a manufacturing-use product and 2 end-use products.

On May 25, 2021, the US EPA released the draft risk assessments of Sulfuryl Fluoride, a residential fumigant targeting termites, powder post beetles, old house borers, bedbugs, carpet beetles, moths, cockroaches, rats, and mice.

The number of pesticides newly registered in China has plummeted from 4326 in 2018 to 294 in 2019 and one of the main causes is the elevated data requirements newly enforced. As an essential component of a dossier, product chemistry data is usually firstly reviewed by the competent authorities. In a training course organized by the Chinese Crop Protection Industry Association in June, Ms. Nancy Shen, technical supervisor of REACH24H, concluded the similarity and differences in the data requirements and exchanged her long years of experience in registering pesticides in China, EU and the United States.

On 17 May 2016, US EPA issued a proposal to approve an amended registration of sulfoxaflor. The amendment was made under the decision of the 9th Circuit Court of Appeals, arguing that the registration of sulfoxaflor in May 2013 was not supported by evidence to demonstrate its safety to bee. EPA reevaluated the data supporting the use of sulfoxaflor and proposes fewer uses and restrictions to reduce the risk to bees. EPA reviewed the amended application from Dow AgroScience to further reduce or eliminate exposure to pollinators: Restricting post-bloom for all proposed bee-attracting crops;  

From the 13th to the 24th of October 2014, the US EPA GLP official Francisca E. Liem visited China where she engaged in a panel discussion with China ICAMA on GLP MAD issues.

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

The US EPA is opening the public comment for registration review of 19 pesticide active ingredients, which are scheduled for EPA’s periodic reviews to ensure that the pesticide continues to satisfy the registration status. Meanwhile, EPA also announces the registration review case closure for oxydemeton-methyl and resmethrin.