Need help ensuring your products comply with EPA conventional pesticide regulations?

A conventional pesticide registration can only be obtained upon providing U.S. EPA with the information and data required by the Code of Federal Regulations. Every item submitted in support of registration must be completed and formatted in compliance with numerous guidelines. Novel conventional registrations normally require pre-consultation with EPA staff. TSG’s scientific and regulatory consultants have extensive expertise in supporting clients in developing product registration strategies, as well as preparing and submitting federal registrations.

Registration Review is the paradigm under which EPA continually reevaluates pesticide active ingredients to ensure their use patterns do not pose unreasonable risk to human health or the environment. While Registration Review is important to technical grade active ingredient registrants, this process is equally important to formulators who rely on registered technical grade active ingredient sources. As the Agency evaluates new data and pesticide exposure in occupational and residential scenarios as well as environmental impacts, it can be concluded that some uses of an active ingredient that were previously acceptable now pose higher exposure or unreasonable risks. Formulators need to be aware of Registration Review activities for the active ingredients they use to ensure that their product labeled uses continue to be acceptable and to timely respond to any required label changes. TSG’s experts routinely support clients throughout the Registration Review process, reviewing labels to ensure compliance and advising on any label changes that are required.

Novel pesticide active ingredients are commercialized after extensive research and development efforts, regulatory data development, and EPA review. Following registration, each new active ingredient is afforded a period of exclusive use where no other company can apply for registration of that same active ingredient without submitting its own extensive suite of toxicology, ecological effects, and environmental fate data. Once the exclusive use period has ended, other companies may wish to register their own “generic” source of the active ingredient, thus fostering competition in the market. Navigating data compensability issues and understanding data requirements can at times be challenging. If your company is interested in the registration of a generic form of any currently registered active ingredient, TSG’s scientific and regulatory consultants can assist in the development of chemistry data and review of relevant databases to inform you of likely compensable data hurdles.

EPA has several honeybee toxicity studies that are conducted as standard guideline ecological effects studies for pesticide active ingredients with outdoor use patterns. In recent years however, there has been a broader awareness of the potential impacts on sensitive pollinator species to select insecticidal active ingredients. Those neonicotinoid insecticides were required to develop additional pollinator protection data and some of required studies are “non-guideline”, meaning that there is no standard EPA guideline published. A total of five “tier 1” studies are now being required on virtually all insecticidal active ingredients with outdoor use patterns: honeybee acute contact toxicity; honeybee adult acute oral toxicity; honeybee larval acute oral toxicity; honeybee adult chronic oral toxicity; honeybee larval chronic oral toxicity; and residual toxicity on treated foliage. EPA will likely be requiring, at minimum, these tier 1 pollinator protection studies on other herbicidal and fungicidal active ingredients as well. If your company is in the position of needing to respond to an EPA Data Call-In or is required to generate pollinator protection data, TSG’s scientific and regulatory consultants can assist in the placement, monitoring, and review of those studies at qualified contract research organizations.