George Fountas, AgriThority® Global Director of Regulatory Affairs, was a featured speaker at the National Alliance of Independent Crop Consultants (NAICC) conference and presented on the topic, “Microbial Permitting and Importation Process in the United States.”
The goal of the Plant Protection Act of 2000 (PPA) is to protect the environment and agricultural land from plant pests, pathogens and other things that could be detrimental to the environment. Under this act, the USDA was tasked with regulating the movement of agricultural products that could be against nature or detrimental to the environment. As such, the USDA needed to create a more formal definition of these pests. They consider microbes (or microorganisms) to be organisms that are too small to be seen by the unaided eye and includes bacteria, fungi, protozoa, microalgae and viruses.
Where Do Microbials Fit Into the Regulatory Scheme?
Legally, microbes are biological control organisms, defined as “any enemy, antagonist, or competitor used to control a plant pest or noxious weed.” The definition in the regulation includes:
- Microbial pathogens used to control invertebrate plant pests
- Microbial pathogens used to control noxious weeds
- Microbial parasites used to control plant pathogens
- Any other types of biological control organisms, as determined by APHIS
However, microbes that are not biocontrol organisms are defined as Plant Growth Enhancers (PGEs) include:
- Materials that typically are added to soil, plants, or the plant-growth environment to enhance plant growth
- These include fertilizers, compost, sludge, manure, microbes, additives, and others, or combinations thereof
It all comes back to the spirit of the regulation. PGEs have the potential to contain pests or plants and plant parts that present a risk to American agriculture and the environment. Therefore, release of these commodities into the environment could be detrimental to U.S. agriculture and the environment. APHIS (Animal and Plant Health Inspection Service) regulates living organisms that could impact animal and plant health.
So, what’s NOT regulated? What are the actual exemptions?
- Biological control organisms that have undergone genetic engineering
- Products that are currently under an EPA experimental use permit, (FIFRA) section 18 emergency exemption, or currently registered with the EPA
None of those require experiments so there is a little bit of a gray area. If you have a registered microbial pesticide and you develop a new formulation that’s not registered with EPA, then that would technically need a USDA agency associated with this to call that out.
When is an APHIS PPQ Permit needed?
Permits are required any time a product is being imported, has interstate movement, or has the environmental release of any microbe that is:
- A known or potential plant pest or pathogen
- A known or potential biocontrol organism
- An organism of unknown risk
These are all activities that would warrant applying for a permit from USDA to get approval to do that. Especially if you have a product registered at the state level and you want to commercialize, you still need a USDA survey.
What happens when you have a permit?
It is important to be prepared with all documentation related to the permit, the field trial itself or the movement of the material to the facility. At the time of inspection, you will likely be asked to provide the permit, protocols, the field, the storage facility. Finally, be prepared to answer questions to confirm the group doing the trials is complying with the conditions of the permit.
The regulatory permitting process can often seem complicated and detailed, but the ultimate goal is to protect the environment. It’s important to understand the responsibilities that coincide with these permits to align with the spirit of the process and protect the agricultural land.
Understanding the terms defined by different regions is an essential first step to determining the regulatory path for a new microbial product. There are many details of the products that can have major impacts on how they are defined and, ultimately, regulated by the different regions. Engaging with the AgriThority regulatory experts early in the product development process can prevent costly missteps while streamlining the path to market.
As the regulatory environment for agricultural biologicals continues to evolve, understanding and navigating these regional differences with AgriThority® support will be crucial for a timely and cost-effective launch. The tailored regulatory solutions are designed to meet the specific needs and goals of your product, and the AgriThority® expertise can guide companies through these complexities to ensure a successful product launch.