Important patent expiries are expected this year, and merger and acquisition activity among agrochemical companies is changing the competitive landscape. Against this backdrop, the history, knowledge and insight about established active substances could get ‘lost’, and such changes may pose risks for reauthorization of plant protection products (PPP). Find out here.
This second blog within the Preserving lifecycles; renewing existing plant protection active substances series provides insight into the US regulation of Active Substances (AS) and Plant Protection Products (PPP). The United States Environmental Protection Agency (EPA) Office of Pesticide Programs handles most of the regulatory issues pertaining to PPPs, using authority from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). All PPPs being sold or distributed in the US must be registered with the EPA. The EPA evaluates the PPP’s proposed usage and labeling, to ensure it will not have unreasonable adverse effects on humans or the environment.
Registration Review Program
The EPA reviews each registered AS at least every 15 years to determine if it meets current FIFRA standards for registration. ASs registered before 1984 have been re-evaluated initially under the re-registration program. These ASs are also subject to registration review.
The EPA plans to review all ASs registered on or before October 1, 2007 by October 1, 2022. Schedules of reviews and consultations before reviews are published and updated annually. New ASs will be added to the schedules as they approach 15 years post-registration. The EPA is planning to start 70 or more new registration reviews in 2017.
Reviews are structured into review ‘cases’ that group ASs together for a number of possible reasons, including their chemical class or structure, mode of action or use.
Figure 1: EPA registration review
A detailed description of the process and procedures can be found on the EPA website under registration review procedures:
The EPA Registration Review Process
1. Docket Opening
Summarizes the pesticide information and the review plan. It contains:
about the pesticide and its use
- The anticipated risk assessment and data needs
- An estimated review timeline
The preliminary workplan undergoes public consultation for 60 days after which a final workplan is published.
2. Focus Meeting
Typically initiated with affected registrants and other stakeholders early in the process. The focus is to identify information needs and provide an opportunity to address areas of uncertainty affecting the risk assessment and risk management decisions. Although not mandatory, they are recommended.
3. Case Development
EPA assesses changes in law/regulation since last review. If new assessment is needed, data gaps are identified, and registrants asked for data call-in (DCI). Risk assessment or risk/benefit analysis is undertaken if needed. The public and regulatory partners are consulted.
4. Registration Review Decision
EPA issues a draft decision with a 60-day comment period. After this point, a final decision is issued on which the registrant must act. In some situations, interim decisions are issued before the final decision. This may require risk mitigation measures, call for new data, and outline schedules for subsequent data submission and review.
EU regulation of ASs and PPPs is explored in the third blog in the series of “How to Renew Plant Protection Products – EU Regulations”.
Everywhere you go, crop protection businesses face an ever-changing commercial and regulatory landscape. But with a good CRO in place, you can supercharge your time-to-market. To learn more about “Preserving lifecycles: renewing existing plant protection active substances” download this informative e-book.
About the author
Gary started his career at Covance in 1985 and is currently the Business Lead Consultant for Crop Protection. As business lead, Gary provides regulatory advice to Covance’s clients to ensure their programs of work and applications for active substance approval or product registration meet the highest possible scientific and regulatory standards set by global authorities.
Covance provides essential research services, models and products for pharmaceutical, crop protection, and chemical companies, as well as universities, governments, and other research organizations. For more information about Covance’s regulatory services for crop protection, click here.