The 5th BioAgTech World Congress 2024 in Raleigh, North Carolina brought together global regulatory administrators to examine the challenges and opportunities in BioAg regulations. With biologicals playing an increasingly critical role in sustainable agriculture, the focus was on expediting market access while upholding rigorous safety standards. This white paper highlights key points from presentations by the U.S. Environmental Protection Agency (EPA), Brazil’s Ministry of Agriculture and Livestock (MAPA), and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE), along with insights from the subsequent Q&A session.
Updates from the U.S. Environmental Protection Agency
Ya-Wei (Jake) Li, Deputy Assistant Administrator for the Pesticide Programs at the U.S. EPA, highlighted the agency’s work on biopesticides, celebrating the 30th anniversary of the Biopesticides and Pollution Prevention Division (BPPD). Since its inception, the division has registered over 3,000 biopesticide products, significantly reducing the use of toxic pesticides and providing farmers with new tools for managing issues like climate change and pesticide resistance.
BT crops, particularly BT corn, have seen a substantial increase in adoption, growing from 8% of U.S. acres in 1997 to 85% today. The EPA is currently reviewing 78 new biopesticide active ingredient applications, but the growing workload has outpaced the agency’s resources. To address this, the EPA is streamlining its review process by pre-screening registration packages and streamlining risk assessments.
Li also discussed the EPA’s ongoing coordination with the USDA and FDA to clarify regulatory roles and processes for biopesticides, addressing the need for clear guidance from research to commercialization. This includes developing a Microbial Decision Tree to simplify the data requirements for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and USDA permits. In biotechnology, the EPA is seeing more applications for biotechnology pesticides, including genetically engineered microbes. The agency is reevaluating processes to find efficiencies and recently exempted certain Plant-Incorporated Protectants (PIPs) from FIFRA and the Federal Food, Drug, and Cosmetic Act (FD&C Act) when they meet safety requirements.
The EPA is also coordinating with USDA and FDA under the White House’s 2022 Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.
On the international front, the EPA is working with agencies like the Organisation for Economic Co-operation and Development (OECD), the United States Trade Representative (USTR), and the USDA Foreign Agricultural Service (FAS) to increase regulatory harmonization and share knowledge with international regulators. The agency’s registration of a novel sprayable RNAi-based biopesticide to fight the Colorado potato beetle (Leptinotarsa decemlineata) was a global first, and the EPA is helping other countries conduct risk assessments for similar technologies.
Li concluded with a note reevaluating regulations for plant biostimulants in the ongoing discussions with congressional offices and the Association of American Plant Food Control Officials (AAPFCO) to determine future actions.
Updates from Brazil’s Ministry of Agriculture and Livestock (MAPA)
Dr. Carlos Goulart, Secretary of Agricultural Defense at MAPA, discussed Brazil’s rapid adoption of biological products in agriculture since 2015, which marks a significant departure from its historically slow regulatory pace for chemical inputs. Unlike the extended approval times for chemicals (six to eight years), biological products in Brazil often receive approval in under a year, with some organic products approved in as little as 144 days. This acceleration has been majorly driven by growers who view biological inputs to stabilize production costs and ensure profitability.
The federal government has played a key role by prioritizing the evaluation of biological products, acknowledging that the data requirements for these are less complex than those for chemical products. One of the most significant revelations is that only less than 10% of Brazilian growers are unaware of biologicals and biotechnology, a stark contrast to other major agricultural nations where this lack of awareness is much higher. This shows the deep integration of biological products into Brazilian agriculture.
Regulators, however, are still working under outdated laws originally designed for chemical products. Efforts are underway in the National Congress to update these regulations, but current frameworks force companies to navigate complex classification and marketing decisions, often limiting broader commercial use. Brazil’s leadership in gene editing regulation, with approvals in as little as 60 days, further highlights the country’s commitment to integrating biotechnology into agriculture, despite ongoing challenges in balancing these advancements with appropriate regulations that can accommodate the complexities of modern agricultural practices.
Updates from the European Commission – DG SANTE
Dr. Klaus Berend, Director for Food Safety, Sustainability, and Innovation at DG SANTE spoke about the efforts within the European Union (EU) to facilitate market access for biopesticides and ensure safer pesticide use. These efforts align with the EU’s Farm to Fork Strategy to transition towards a more sustainable food system, which includes reducing the use of chemical pesticides by 50% and increasing organic production to 25% of agricultural land by 2030.
Regulatory updates made to ease the assessment and approval process for biopesticides, particularly microorganisms, include new data requirements, risk assessment principles, and support for applicants through guidance documents and explanatory notes. The EU has also invested in training for national authorities of member states to enhance their expertise in evaluating biopesticide applications.
There is a growing interest in biopesticides within the EU, mirroring trends seen in the U.S. and Brazil. This is evident in the increasing number of biopesticide applications, which now constitute most new pesticide applications in the EU. Demand is driven by factors such as consumer awareness, environmental concerns, and the need to address chemical resistance in pests.
Ongoing challenges include the strain on regulatory authorities due to the rising number of applications and the need for more resources to expedite the approval process. The talk concluded with the ongoing challenges, particularly in addressing antimicrobial resistance and the need for specialized expertise in biopesticide evaluations. The EU is also keenly exploring innovative alternative biocontrol methods, such as RNAi gene editing, and peptide-based substances.
Q&A Highlights
International Harmonization and Regulatory Timelines
Panelists discussed the potential for mutual recognition of registrations across different jurisdictions. Carlos Goulart highlighted the possibility of partial data sharing to streamline processes and reduce costs for companies while noting the need for localized assessments for health, environmental, and agricultural sectors. Amanda Pierce, Senior Advisor in the Biopesticides and Pollution Prevention Division (BPPD) at the U.S. EPA agreed that while complete acceptance of another country’s risk assessments is not feasible, there is room for greater harmonization in dossiers.
Regarding the lengthy registration timelines in the EU, Klaus Berend acknowledged that some biopesticide registrations have been completed more quickly but delays often stem from thorough risk assessments and peer reviews. Improving efficiency may not require legislative changes but rather the establishment of specific structures and a commitment from political leaders to accelerate the process.
The Industry’s Role in Expediting Registrations
In addressing how the industry can support faster registrations in Europe, Klaus Berend emphasized the importance of submitting well-prepared application dossiers. Increasing awareness and acceptance of biopesticides among European farmers can influence regulatory priorities. Engaging farmers and ensuring their interest in biopesticides is communicated to policymakers can help secure the necessary resources to expedite the registration process.
The discussions at the 5th BAW Congress 2024 highlight the importance of global collaboration in BioAg regulations. Progress is evident in the U.S., Brazil, and the EU, yet challenges remain in streamlining processes and ensuring timely market access. Future success will depend on continued collaboration between regulators and industry, along with a focus on innovation and sustainability.
Speakers/Panelists:
- Jake Li is the Deputy Assistant Administrator for Pesticide Programs at the U.S. Environmental Protection Agency (EPA), overseeing pesticide regulation and evaluation.
LinkedIn | EPA Bio - Dr. Amanda Pierce is the Senior Advisor in the Biopesticides and Pollution Prevention Division (BPPD) at the US EPA
LinkedIn | EPA Contact - Dr. Carlos Goulart is the Secretary of Agricultural Defense at the Ministry of Agriculture and Livestock (MAPA) in Brazil, responsible for agricultural defense policies and biosecurity standards.
LinkedIn | Official Bio - Dr. Klaus Berend is the Director for Food Safety, Sustainability, and Innovation at DG SANTE within the European Commission, managing food safety regulations and sustainable agricultural practices.
LinkedIn | EU Bio
