Three Need-to-Know Facts About U.S. Regulations and ESA Update

AgriBusiness Global spoke with two regulatory experts about the changes happening for the United States (U.S.) regulation of crop protection products. Robert Kiefer, General Manager of REACH24H USA and Driss Benmhend, USA Group Leader, Regulatory Affairs for Crop Protection and Nutrition at knoell gave their insights into what the U.S. Environmental Protection Agency (EPA) is doing for this year and beyond.

1. 1. The Pesticide Registration Improvement Act of 2022 (PRIA 5)

While the EPA is struggling to streamline and keep up with submissions, work is happening to address backlog issues.

“[The Pesticide Registration Improvement Act] PRIA 5 has been in force for more than a year. One goal of PRIA 5 is to collect more fees from the industry to help with EPA budget challenges,” says Kiefer.  “However, EPA funding is still significantly below the minimum level. EPA faces significant workload challenges this year due to limited resources. Limited reviewers manage a substantial volume of submissions. These factors, compounded by frequent registrant inquiries, make it increasingly difficult for EPA to maintain productivity on the backlog of submissions.

“At the same time, EPA is working on improving transparency regarding the status of submissions in the review process by upgrading its IT system,” Kiefer continues.  “It is also important to keep in mind before application submission to address all the data requirements upfront and prepare a complete dossier, always making sure to cover everything before the application submission. EPA recommends scheduling a pre-submission meeting head of time to confirm requirements.”

1. 2. Bilingual Spanish Labeling for Pesticide Products

Changes in labeling is requiring companies to translate current English labels into Spanish.

“The EPA is requiring Spanish labels for all pesticide products. This new mandate, which starts in 2025 through 2030, comes from the newest revision of the PRIA 5. The intent is to make pesticide labels and safety information more accessible for farm workers,” says Driss.  “Products will need to have Spanish translations of the label or have a Spanish Safety Data Sheet (SDS), depending on the type of product. The translations need to be available for the customers and users of the products. Different products have different deadlines, and products are prioritized based on toxicity.”

1. 3. Biopesticide Tiered Testing

Biopesticides are often used in integrated pest management (IPM) programs and regenerative farming practices, which is being supported by U.S. consumers.

“Recently, the market for biopesticides is expanding rapidly, driven by a combination of greater environmental and health awareness, sustainability, regulatory pressure, and demand from retailers. The U.S. biopesticides market ranks first in the world, accounting for 1/3 of the total global market,” says Kiefer. “Since biopesticides tend to pose fewer risks than conventional pesticides, U.S. EPA generally requires less data to register a biopesticide than a conventional pesticide. To achieve this, the Agency has adopted a tiered testing scheme to assure the safety of biopesticides. Only adverse effects in a lower tier will trigger additional testing in the next higher tier. Additionally, the EPA’s review times for biopesticides are shorter. All above making it a very good place to launch a biological product.”

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ESA and EPA Duplication: Is It Feeding the Backlog?

Interview with Driss Benmhend

 Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), pesticide registrants are required to provide voluminous data to EPA before a product may be registered. Some of the data required by EPA are studies on the impacts of prospective products on species that are listed under the ESA. EPA conducts risk assessments on the possible impacts of proposed products on plant and animal species, including listed species, as one factor in its consideration of whether and under what conditions to register a pesticide product.

Once a product is registered, FIFRA provides under re-registration another opportunity for review to assure the continued safety of the product.

Similarly, the ESA also contains a process by which a federal agency (such as EPA) consults with the United States Fish & Wildlife Service (FWS) or the National Marine Fisheries Service (NMFS) to ensure that any action the agency authorizes, funds, or carries out is not likely to adversely affect wildlife species protected by the ESA. In the course of this consultation process, FWS and NMFS conduct evaluations of the proposed agency action, which are very similar to the risk assessments already undertaken by EPA in the registration or re-registration of crop protection products.

Under any circumstances, risk assessments are expensive, time-consuming, and data-intensive exercises.

Many industry representatives and regulatory stakeholders agree the current procedures are duplicative, requiring EPA and other Services to conduct essentially the same risk assessments. All three agencies conduct thorough and comprehensive assessments on the listed species, generating data and developing information that would be helpful to one another’s work but is not shared accordingly. This redundancy leads to inefficiencies within the review, both slowing the registration review process and adding to governmental spending. It also leads to the regulatory gridlock confronting farmers and ranchers as a result of the failure of these agencies to reconcile their procedures.

The duplication of the risk assessment requirements for crop protection registration by EPA and for ESA Section 7 consultation by the Services is a prime example of the waste that exists in our federal agencies. While both EPA and the Services have legitimate roles to play by virtue of the responsibilities that Congress has given them in the FIFRA registration process and in the ESA Section 7 consultation process, good government demands that EPA and the Services get together to determine how best to work with one another to satisfy the missions of both FIFRA and ESA through one, joint process.

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Can You Give An ESA Herbicide Strategy Case Study?

Interview with Robert Kiefer

In an effort to comply with the Endangered Species Act (ESA) and to reduce the uncertainty of continuous pesticide use on growers, the EPA has spent lots of time and effort on endangered species assessment in recent years. Below we will take herbicides as an example to show what EPA has achieved.

EPA has released its final Herbicide Strategy in August 2024. Unlike EPA’s historic pesticide-by-pesticide, species-by-species approach, which could be time-consuming and resource-intensive, the final Herbicide Strategy takes a more proactive way. By identifying in advance the hundreds of listed endangered species (mainly listed by the U.S Fish and Wildlife Service – FWS) to be protected, EPA establish a framework that could be applied to the registration and registration review for thousands of pesticides (conventional herbicides) used in agricultural practices. The Herbicide Strategy is designed to focus regulatory efforts on areas where they are most needed. This streamlined strategy greatly accelerates EPA’s review of herbicides while ensuring the protection of endangered species.

While the Herbicide Strategy does impose some additional requirements on companies registering new herbicide products, these burdens are generally considered to be minimal. There are only two main concerns that companies need to focus on during new product registration.

1. Provide additional exposure and toxicological data for herbicides on relevant endangered species in addition to the common data.
2. Pesticide product labels must now include specific information regarding the required protections for endangered species and the mitigation measures that must be implemented to minimize potential harm.

This ensures that agricultural producers are fully aware of their obligations and can take appropriate steps to comply with environmental regulations.

The final Herbicide Strategy reflects more input of the applicators. But at the same time, the strategy reduces the level of mitigation needed and provides applicators with more options for mitigation measure. EPA is now developing websites such as Bulletins Live! Two (BLT) and the Mitigation Menu to assist applicators in implementing effective mitigation measures.

The final strategy has helped resolve all the lawsuits received by EPA for not complying with ESA. By providing greater clarity and consistency in the regulatory framework, the strategy not only contributes to the protection of endangered species, but also benefits the agricultural producers in herbicide application and pesticide companies in product registration.  •

 

Photo Credits: Driss Benmhend, knoell USA, LLC;  Robert Kiefer, Reach24H USA, Inc.