Frequently Asked Questions
1. What is occupational risk assessment, not dietary risk assessment?
This assessment estimates the exposure and safety of those who handle the product (operators and workers) and of people who live or circulate near the treated areas (residents and passersby). It is a requirement of the main regulatory authorities and, more recently, has also gained standardized guidelines in Brazil, with ANVISA's RDC No. 998/2025.
2. O que é a avaliação do risco ocupacional e não dietético?
To demonstrate to regulatory authorities that the product can be used safely. The process cross-references the product's toxicological data with estimates of human exposure. It is based on this assessment that the conditions for safe use indicated in the product information leaflet are defined, such as mandatory PPE, re-entry interval, and safety interval.
3. What is the difference in the evaluation of conventional pesticides and bio-inputs?
Both require a demonstration of safety, but bio-inputs have specific regulatory frameworks adapted to their biological nature. Therefore, the strategy for toxicological studies is usually defined on a case-by-case basis, in order to build a consistent dossier and avoid unnecessary studies.
4. When are additional toxicological studies necessary?
In general, when the available dataset does not meet the requirements of the authorities, or when the product needs complementary data (refinement) for its intended use to be accepted, before planning new in vivo studies, we evaluate technically defensible alternatives, such as non-animal methodologies (NAMs) and scientific justifications, which can reduce costs and timelines.
5. What should you do when you receive a technical requirement from a regulatory authority?
The first step is to accurately understand the evaluator's scientific concerns. From there, the strategy is defined: respond with the available data, prepare a technical defense based on scientific literature, or generate new information. A well-founded response aligned with what was requested reduces the risk of new requirements and delays in the process.
6. What is regulatory foresight and how does it support company decisions?
It is the application of strategic foresight to the regulatory environment. It consists of the continuous mapping of rules, trends, and signs of change in the sector to anticipate their impacts. This anticipation allows for the analysis of the company's portfolio, identifying regulatory weaknesses and new opportunities, and provides a basis for long-term strategic decisions.
7. How does Priscience support the registration and development of my product?
We work in human health safety assessment and regulatory strategy for agricultural pesticides and bio-inputs in Brazil, Latin America, and on projects in Europe and Asia-Pacific. From planning and interpreting toxicological studies to risk assessments, from preparing dossiers and technical defenses to meetings with authorities, we support companies in meeting regulatory requirements with scientific rigor. With regulatory foresight, we help anticipate changes that affect the portfolio, and we offer tailored training and workshops for technical and management teams.
