TSG Consulting recently hosted a panel discussion exploring the process of registering new products in these categories. Before we go on to highlight five key questions that industry posed to our panel, we start with taking a look at the regulatory framework for biopesticides and biostimulants.

US regulatory framework for plant growth regulators as biopesticides and biostimulants

A biopesticide – in terms of the US regulatory framework – is a pesticide that contains an active ingredient which is naturally occurring, has a demonstrative history of minimal toxicity, and acts on the target pest with a non-toxic mode of action. Often falling into this biopesticide category are plant growth regulators (PGRs). A PGR is a substance or mixture of substances, through physiological action that accelerates or retards the rate of plant growth, accelerates or retards the rate of plant maturation, or otherwise alters the behavior of plants or the produce thereof.  It can also be considered a PGR if the substances or mixture of substances do not fall under one of the exclusion categories listed in 40 CFR §152.6(f) & (g) as vitamin-hormone products, plant nutrients, plant inoculants or soil amendments or under 40 CFR §152.8(a) as a fertilizer. A biostimulant, meanwhile, currently has no applicable regulatory definition under FIFRA or any other federal statute, and the term cannot appear as a claim on product labels or marketing materials. The latest iteration of what a “plant biostimulant” is comes from a USDA 2019 Report where it is stated “a plant biostimulant is a substance(s), microorganism(s), or mixtures thereof, that, when applied to seeds, plants, the rhizosphere, soil or other growth media, act to support a plant’s natural nutrition processes independently of the biostimulant’s nutrient content. The plant biostimulant thereby improves nutrient availability, uptake or use efficiency, tolerance to abiotic stress, and consequent growth, development or yield.” As stakeholders have observed, varying interpretations and

applications of these two definitions have produced significant marketplace uncertainty.

The process of registering a PGR as a biopesticide in the US is well-defined and, like any other pesticide, must be obtained through the Environmental Protection Agency’s (EPA) Biopesticides and Pollution Prevention Division (BPPD), with separate registrations as a pesticide  at the state level. This same defined registration process is not the case for biostimulants, which are not registered at the federal level. State registration of products containing biostimulants is required, but the process and standards applied can vary widely from state to state.

Five key questions about US biopesticide and biostimulant regulations answered

1.What do I need to know about EPA’s 2019 draft guidance and its 2020 update?

EPA drafted a document for public comment in early 2019 that provided insight into how biostimulants fit into the existing structure. The key issue with the original guidance document pertained to EPA identifying a particular list of active ingredients that EPA has historically categorized as PGR active ingredients (the infamous Table Four in the original guidance). Included with that initial list were substances that could act both as a PGR as well as a plant biostimulant. The lists of ingredient and example claims  were intended as examples but – given the absence of any other available guidance – many states defaulted to utilizing that initial guidance document and considering it as comprehensive and all-inclusive. Many feel that this narrows a field that EPA intended to support by issuing the document in the first place.

EPA issued an updated version in late 2020, which contains some significant changes that businesses need to be aware of. One key difference is how substances are identified and discussed. The 2019 document lacked context in EPA’s categorization of a bulk list of active ingredients, appearing as though EPA was saying that all the substances listed – including those, like seaweed extracts, that have dual-uses – needed to be registered as PGRs. EPA removed Table Four from its 2020 update and instead discussed more broadly the uses and claims of many of those ingredients, categorizing some as exclusively PGRs and explaining that others could have dual, PGR and non-PGR, uses. EPA acknowledges that, in some cases, substances having multiple modes of action may be included in products that are not registered as pesticides. Companies seeking to commercialize a plant biostimulant product need always be cautious about claims being made on the product so as not to inadvertently promote the product as a PGR as well as understanding their product’s mode of action.

2.Is the definition of Plant Growth Regulator changing?

The definition of Plant Growth Regulator (PGR) as codified under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and EPA’s position on PGRs being subject to registration isn’t changing. PGRs remain categorized as a substance or mixture of substances that enhances, promotes or delays growth, the onset of fruit maturation, or that changes the plant physiologically. While the definition of PGR remains unchanged, EPA is trying to clarify certain issues with its updated guidance document, including emphasizing the types of claims that are considered PGR claims versus those that are not and indicating substances that exclusively possess PGR activity versus those substances that can act on a plant both with or without PGR functionality. Some substances are clearly PGR-only, and for other substances the burden falls to the manufacturers to demonstrate that their product doesn’t fall into the PGR category.

3.Will the M009 procedure be adopted as the long-term regulatory process for biostimulants?

The process is currently voluntary and it’s unlikely that EPA will make M009 (regulated versus non-regulated) determinations mandatory. States may prefer its adoption since ultimate regulatory determination can be made federally by EPA, and some state regulators will leverage the M009 EPA filing with a registrant prior to being able to sell a product in that state. Businesses will need to defend their decision on product positioning as a plant biostimulant and not seeking an M009 determination by explaining their product’s mode of action and efficacy. The explanation should include data which demonstrates that the product is not functioning as a PGR. In short, if you want to avoid having to go down the M009 route, you need to be able to put together a convincing argument as to why you shouldn’t need to.

4.Do states have guidance on efficacy trials with respect to supporting biostimulant claims such as abiotic stress tolerance?

States don’t currently have guidance on dealing with biostimulants. Some have guidance for soil or plant amendments and there are a few, such as Illinois and Kansas, that have more extensive guidance, but they don’t specifically address biostimulant claims. These states want to see trial data that addresses growing conditions and crops typical for their state. States want to know that a product will work as intended in their local environment, and industry is working on options for how you prove that, but there currently isn’t guidance for anything as specific as abiotic stress tolerance.

5.Is there any reciprocity or advantage to being registered outside of the US?

Even if your product is registered in other countries, you still must go through the process of registering in the US. If you have a compelling case that your product is a biostimulant – or that it fits into one of the exempted categories under 40 CFR 152.6 – that will certainly help. Businesses may have supporting data or information from trials that have been conducted, or have some historical knowledge on the use and functionality of their formulation that they can use in the state registration process, but there's no reciprocity – US state regulators and EPA will still have to make their own decisions.

Being registered as a biostimulant elsewhere can in fact cause additional issues at the state level. Biostimulant is currently a trigger word – and has been for several years – and states are extremely cautious. If they see the term associated anywhere with your product, perhaps during an online search for example, then they are likely to ask additional questions and you will need additional data to support your claims.

To watch the full discussion, please click on the following link: Meet the experts: A panel discussion on strategic considerations for biopesticides and biostimulants.

Details of upcoming webinars can be found on the events section of our website.

How TSG can help

TSG regularly helps clients navigate both federal and state regulatory processes in the US for all types of pesticides – including biopesticides and biostimulants. Our regulatory and scientific experts can assist with:

• Identifying if your product is exempt from regulation as a plant regulator
• Developing a product registration strategy
• Developing labels and claims
• Obtaining Company Number and Establishment Numbers
• Preparing and submitting biochemical classifications and non-FIFRA regulated determinations
• Preparing for and participating in EPA pre-submission meetings
• Preparing and submitting pesticide inert petitions
• Placing and monitoring studies with contract research labs
• Preparing data waivers rationales
• Conducting compliance audits including recordkeeping requirements
• Reviewing ingredients
• Addressing efficacy data requirements
• Preparing and submitting federal and state registrations
• Maintenance activities like renewals and tonnage reporting

Need help determining where your pesticide product falls in accordance with US regulations? Please get in touch at [email protected]