When developing a new animal drug, the National Environmental Policy Act of 1969 (NEPA) requires sponsors to consider the potential impact of their drug on the environment [1]. This is a critical step in protecting not only the ecological integrity of the surrounding area, but also the human environmental health. Animal drugs can be introduced into the environment through the manufacturing process, drug-use, or disposal. Once in the environment, the drug could potentially have unintended consequences on the vertebrates, invertebrates, plants, fungi, and bacteria. For example, if an animal drug is still present in the animal’s waste after it has been ingested, it can be introduced to the environment through run-off or other means. NEPA exists to safeguard the environment from these potential negative impacts and ensure that significant environmental effects are considered and alternative actions
In order to comply with NEPA, sponsors must submit an Environmental Assessment (EA) [1]. This can be a confusing and time-consuming process, but we can help. If you need support authoring your EA, contact us at 248-987-4497 or email us at info@emmainternational.com to learn more about how our experts can support your team.
There are two different phases for environmental impact assessments (EIA’s) for veterinary medicinal products (VMP’s). Phase 1 helps the sponsor determine whether the VMP is eligible for a categorical exclusion (CE) or if the sponsor should proceed to phase 2 with the EIA [2]. If the sponsor qualifies for a CE, they do not need to submit an EIA and will instead submit a CE. If they don’t qualify for any CEs, move onto Phase 2. Phase 2 provides guidance on writing the EIA and recommends ways to protect the environment [3].
Next, the Center for Veterinary Medicine (CVM) reviews the EIA and if they determine that no significant environmental impacts are expected, a Finding of No Significant Impact (FONSI) is prepared [1]. If significant environmental impacts are anticipated, the sponsor must prepare an Environmental Impact Statement (EIS) [1]. The statement describes the actions the sponsor plans to do, how they will impact the environment, and alternative actions [1]. The agency reviews the EIS and makes a Record of Decision (ROD).
EMMA International is here to provide full-circle solutions for all aspects of submitting your NADA. Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can take the stress out of quality and regulatory compliance!
[1] FDA (2024) Environmental Impact Considerations, Retrieved on 18 October 2024 from: https://www.fda.gov/animal-veterinary/development-approval-process/environmental-impact-considerations
[2] Center for Veterinary Medicine (2001) CVM GFI #89 (VICH GL6) EIAs for Veterinary Medicinal Products – Phase I, Retrieved on 18 October 2024 from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-89-vich-gl6-eias-veterinary-medicinal-products-phase-i
[3] Center for Veterinary Medicine (2006) CVM GFI #166 (VICH GL38) Environmental Impact Assessments (EIA’s) for Veterinary Medicinal Products (VMP’s) – Phase II, Retrieved on 18 October 2024 from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-166-vich-gl38-environmental-impact-assessments-eias-veterinary-medicinal-products-vmps-phase
