Fera Science Webinar – Overcoming registration challenges in the United States
Fera Science Webinar – Overcoming registration challenges in the United States
In late June Fera Science held a webinar entitled: “From Research to Regulation: A deep dive into bacteriophage applications and challenges”. The webinar focused on bacteriophages (viruses that devour bacteria) as a form of biocontrol against microbial pathogens. The webinar featured five guest speakers who discussed academic research, regulation, and commercial applications of bacteriophages.
Dr. Sammy Frenck, the R&D manager from EcoPhage delivered the presentation “Overcoming registration challenges in the US”. He gave an overview of the company, whose main goal is the marketing of bacteriophage solutions to treat disease.
Dr. Frenck discussed the regulatory differences between the United Sates (US) and Europe, along with the challenges faced by both. Europe takes the longest time to obtain a registration (7-10 years) for a bacteriophage while in the US it can take only 12-18 months to obtain a registration. For US registration, the EPA doesn’t require performance (efficacy) testing and offer a lot of waivers for biological products, making it an easier registration than Europe. There is an obstacle in that the USDA requires that the microbial organism be indigenous to the US making it difficult to use foreign or novel strains in microbial products. Overall, across the world defining bacteriophages and introducing new varieties or combinations (“cocktails”) to the market is a regulatory challenge. This emphasises a need to use genomics to showcase organism similarity with native species.
According to Dr. Frenck using combinations of bacteriophages is easier to do in the US as once the first isolate within a species has been approved, other isolates can be approved following a lighter assessment based on the reference isolate data. In other words, it is easier to update your bacteriophage cocktail in the US, while in Europe every bacteriophage isolate is treated as a new active substance.
Presentations such as this one are important in showcasing the onerous requirements implemented by certain jurisdictions and the potential to learn from other Regulations in order to streamline the registration process. This rings especially true for bacteriophages since the US EPA concluded that these products when used in accordance with good agricultural practice presented minimal or negligible risks to operators, consumers or the environment.
If you need any support with the registration of plant protection products in Europe please do not hesitate in contacting one of our regulatory consultants at info@kerona.ie