Regulatory Journey
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More than 90 regulatory bodies around the world charged with protecting human health and the environment have approved the safety of 2,4-D when used as directed — including Health Canada, the European Food Safety Authority (EFSA), the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the U.S. Environmental Protection Agency (U.S. EPA)."
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Regulator Spotlight: U.S. Environmental Protection Agency (EPA)
The U.S. EPA follows a rigorous review process to evaluate the safety of pesticide products — a process called registration review — that is repeated at least every 15 years.
For each pesticide it reviews, the U.S. EPA evaluates hundreds of different scientific studies during the registration and re-registration process, relying on the best science available and placing high value on transparency in decision-making.
During the process, the U.S. EPA may receive and review studies and information from manufacturers, third parties and the public, and takes findings and questions to independent expert panels such as the FIFRA Scientific Advisory Panel and the National Academy of Sciences.
The U.S. EPA assesses and evaluates the potential for:
- Harm to humans (including risk from short-term toxicity as well as long-term effects such as cancer and reproductive system disorders), wildlife, fish, and plants, including endangered species and non-target organisms.
- Contamination of surface water or ground water from leaching, runoff, and spray drift.
- Product labels and directions for use are then written specifically to avoid those kinds of harm. Not using a pesticide according to its label is illegal and can result in federal and state fines.
As recently as 2020, the U.S. EPA reaffirmed its review of all available human health data on 2,4-D in a Human Health Assessment completed during the re-registration process for a major crop protection product and approved the safety of 2,4-D when used as intended. As part of that process, the U.S. EPA reviewed its previous findings as well as the most up-to-date human health safety data and information about 2,4-D, including dozens of new studies.
To learn more about the U.S. EPA’s rigorous pesticide review process, visit EPA’s website.
Regulator Spotlight: The European Food Safety Authority
In the European Union, the European Food Safety Authority (EFSA) is the regulatory agency in charge of scientific advice and risk assessment for pesticides.
EFSA is responsible for the peer review of the risk assessment of active substances used in plant protection products. It is also responsible for the evaluation of Maximum Residue Levels (MRLs) to ensure pesticide residues in food do not pose unacceptable risks to consumers. The evaluation of formulated plant protection products is carried out at national level by the regulatory authorities of EU Member States.
For the evaluation and re-evaluation of active substances, a Rapporteur Member State is appointed to carry out the initial risk assessment. This assessment is then peer reviewed by EFSA together with all Member States. It is a transparent process with public consultations.
This risk assessment is rigorous and active substances need to be proven safe for human health, animal health and the environment to meet the stringent approval criteria under EU regulation. The approval period is up to 15 years and active substances are systematically reviewed to ensure the latest scientific knowledge has been considered.
Once EFSA risk assessment is complete, the approval decision goes to the European Commission and Member States as risk managers
To learn more about EFSA’s thorough pesticide review process, visit EFSA’s website.
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[EMBED REGULATORY JOURNEY INFOGRAPHIC FROM OTHER AGENCY WHEN FINAL]