There is pressure worldwide for better, faster access to biological alternatives to conventional crop protection chemicals (CPCs). The U.S. Environmental Protection Agency (EPA) is ahead of regions such as the European Union (EU) in revising its regulatory approaches for biopesticides and in having a division dedicated to them, namely, the Biopesticides and Pollution Prevention Division (BPPD). Read on to discover how this can help you speed your biopesticide to market in the U.S.
What’s different about biopesticides compared with conventional plant protection products?
Biopesticides are generally perceived as inherently less dangerous than conventional, synthetic CPCs, but biological-derived substances have dangers and need regulation. Around the world, differing philosophies of safety for human health and the environment drive related regulatory approaches.
In this respect, the U.S. EPA recognizes biopesticides as a separate category comprising biochemical pesticides, microbial pesticides and plant-incorporated protectants (PIPs). In contrast, the EU does not generally distinguish biopesticides from conventional chemicals, though it has recently refined risk definitions and assessments for microorganisms, and it regulates PIPs as genetically modified organisms. You can read more about the EU approach in our blog “What the latest changes to EU regulations and data requirements mean for your microbial biopesticide registrations and renewals” and our e-book “Regulatory Revolution in Biopesticide.”
How have regulators accommodated the unique nature of biopesticides?
On both sides of the Atlantic, the core legislation is as follows for conventional pesticides:
- U.S.: based on Federal Insecticide, Fungicide, and Rodenticide Act (1947), with Federal Food, Drug, and Cosmetic Act (1938) and Food Quality Protection Act (1996) additions
- EU: Regulation (EC) No 1107/2009, with Regulations (EU) No 283/2013 and 284/2013 in which Part A defines the data requirements for chemical active substances and products. For semiochemical and botanicals, no specific data requirements exist. For these two categories, Part A should be considered. The data requirements for microbial active substances and products are covered under Commission Regulation (EU) 2022/1439 and Commission Regulation (EU) 2022/1440 (in force from November 2022), respectively.
But different adaptations have been deployed to promote biopesticide development. U.S. EPA reflects a risk-based mindset in a more flexible and tailored approach in contrast to the EU hazard-based thinking and regulation for conventional substances. Accordingly, biopesticide active ingredients (AIs) and products achieve U.S. registration in 12-20 months1 (down from approximately 36 months for conventional CPCs),2 whereas EU biopesticide approvals take 2.5-3.5 years.2
Summary of differences between U.S. and EU biopesticide regulation
|Reviewing authorities||BPPD (dedicated biopesticides division)||Multiple authorities, each with potential for delay (especially RMSs)|
|Review framework||BPPD runs pre-submission meeting, initial and preliminary screens, scientific review and decision||One RMS reviews dossierA EFSA performs risk assessment MSs + EFSA peer review MSs vote on subsequent EC dossierB|
|Authorization of products containing AI||Up to 5 products authorized with AI||Separate product authorization: via one MS, then by mutual recognition applicationsC|
|Testing requirements||Tailored to AI in BPPD pre-submission discussion||Pre-set (though discussion with RMS is recommended)|
|Testing guidelines||Biopesticide-dedicated OCSPP seriesD||Few dedicated guidelines except aspects potentially increasing study burdenE|
|Tolerance (MRL)F||Exemption petition required (but to 2014, no microbial pesticides or PIP required tolerances)||Residues in or on treated products, food and feed are not required for microorganisms. Addresses only metabolites, which are a hazard for humans: studies as for Part A of Regulation (EU) No 283/2013 are required if consumers are exposed|
|Accelerated decision review time||Yes||Only if strict low-risk criteria are met: 120 days instead of a year|
|Fees||Reduced under PRIA (for all biopesticides)||As for conventional pesticides|
|Territory covered by approval||U.S.-wide, subject to registration in each stateG||EU-wide for AI but separate process for products (see above) G|
|Life of AI registration||15 years (federal)||10 years (15 years if low-risk classification is achieved)|
A For active substance + ≥1 product. B In PAFF Committee. C In EU geographical zones. D OCSPP series 880 (biochemical), 885 (microbial). E For example, microbial resistance and secondary metabolite assessment. F Tolerance (U.S.) and MRL (EU) are maximum level permissible in food. G As for conventional AIs.
AI, active ingredient; BPPD, Biopesticides and Pollution Prevention Division; EC, European Commission; EFSA, European Food Safety Authority; MRL, maximum residue level; MS, member state; OCSPP, Office of Chemical Safety and Pollution Prevention; PAFF, Standing Committee on Plants, Animals, Food and Feed; PRIA, Pesticides Registration Improvement Act; RMS, Rapporteur Member State.
What are the highlights of the accelerated U.S. pathway for biopesticide regulatory approval?
Key to EPA’s approach is a single dedicated division—BPPD within the Office of Pesticide Programs—with in-depth experience and understanding of biopesticides and a mission to encourage biopesticide use. Contrast this with multiple authorities involved in the EU process, as well as the variable levels of experience possessed by the different rapporteur member states taking AIs through the initial review and corresponding variable potential for delay. Specialization within the BPPD means even deeper understanding of AIs, with a microbial branch (including PIPs and other biotech-related products) and biochemical branch.
The EPA process is built on presumption of low risk, whereas the EU assumes high risk until proven otherwise. BPPD brings its specialist knowledge to the task of working with you to create a bespoke testing program under Office of Chemical Safety and Pollution Prevention guidelines, reducing data burdens without increasing the likelihood of harm.
Further aspects of the U.S. approach create economies of time and cost. A tiered approach to biopesticide toxicology means that higher-tier tests only need to be performed if lower-tier results mandate them. Greater use can be made of data from the literature and scientific sources for biopesticides; these were not routinely accepted in the EU before November 2022 regulatory amendments for microbial dossiers. Lower data requirements and reduced fees and timelines under the Pesticides Registration Improvement Act result in a faster, more economical regulatory journey in the U.S. and registration for 15 years instead of the EU’s 10 years. By the end of 2019, EPA approved around 1,400 biopesticide registrations, involving nearly 400 AIs,3 with the U.S. becoming the world’s largest country for biopesticide sales.3
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What does this mean for your biopesticide ingredient or product when preparing a U.S. regulatory submission?
If you have already made an EU submission, you will have a wealth of data to pull into pre-submission discussion with BPPD, reducing study requirements and accelerating registration. A U.S. submission may get your AI and products to market quickly; this could mean you start recouping development costs while the EU review progresses. Either way, it’s worth keeping in mind that many countries follow a U.S.-like approach, so a U.S. submission may smooth the path to successful approvals in multiple jurisdictions.
How can Labcorp’s teams help you navigate the U.S. regulatory landscape for biopesticides?
To optimize the regulatory strategy for your biopesticide in the U.S., you will need in-depth understanding of EPA regulations. Let Labcorp’s global regulatory team leverage its experience in U.S. and EU biopesticide submissions to do this. We can support you in pre-submission discussion with EPA, study program design and execution, dossier preparation, and submission and post-submission support. We will keep you abreast of EPA’s thinking, smooth the regulatory journey and guide timely renewals.
Consider Labcorp your source for testing, as well as regulatory consultancy, for building datasets for the U.S., Asia and the EU, including U.S.-compliant safety and physical chemistry testing services and microbiological expertise. Benefit from our comprehensive approach and more than 50 years’ experience providing testing and regulatory services.
Visit our website for more information about our regulatory services for biopesticides and crop protection. Ready to start a conversation? Contact us today.
- PRIA fee category table – Biopesticides and Pollution Prevention Division (BPPD) – new active ingredients. U.S. Environmental Protection Agency. Updated March 7, 2023. Accessed December 2022. https://www.epa.gov/pria-fees/pria-fee-category-table-biopesticides-division-new-active-ingredients
- Teicher H. Biopesticide regulation: a comparison of EU and U.S. approval processes. AgriBusiness Global. February 28, 2018. Accessed December 2022. https://www.agribusinessglobal.com/biopesticides/biopesticide-regulation-a-comparison-of-eu-and-u-s-approval-processes/
- Zheng P. Registrations of microbial pesticides in U.S. from 2015 to 2018. Agropages. September 30, 2020. Accessed December 2022. https://news.agropages.com/News/NewsDetail—36147.htm