With billions of companion and agricultural animals in the United States alone, it’s clear that human and animal lives are deeply interconnected, especially when it comes to care and treatment. Veterinary care goes far beyond providing food and water; it includes a wide range of medicines whose manufacturing process, end-use runoff, and ultimate disposal can have significant environmental impacts. From hormone implants to flea and tick treatments, veterinary pharmaceuticals play a major role in our modern world. 

The Food and Drug Administration’s Center for Veterinary Medicines (CVM) is charged with ensuring the safety and effectiveness of animal drugs and food additives and determining if these products will have a significant impact on the environment. To accomplish their mission, CVM requires approval applications from sponsors to include either a claim for a categorical exclusion or an Environmental Assessment (EA). A categorical exclusion will indicate whether a proposed action falls under conditions that the agency has determined from previous information does not have a significant effect on the environment. 

The EA compiles environmental fate, exposure, and effects data related to the use and disposal of drugs or feed additives to allow CVM to determine whether significant environmental impacts may occur from the proposed action. The EA will allow CVM to either conclude Findings of No Significant Impacts (FONSI), the need for Risk Mitigation Options, or, if significant impacts remain identified, the issuance of an Environmental Impact Statement (Figure 1). 

Waterborne’s scientists have assisted clients around the world in preparing EAs to help ensure proper environmental stewardship of their veterinary medicines and food additives for companion animals, aquaculture, and livestock. What we’ve learned over the years is that EAs come in all shapes and sizes and are driven by a variety of veterinary medical needs. For example, our own work has led us to projects for:

• Livestock growth hormone implants. Developed models and automated procedures to evaluate the risks of hormone releases to the environment from pasture cattle, feedlots, and manured cropland.
• Sedation of fresh water-reared finfish. Evaluated the fate, dissipation, and effects of drug in hatcheries, raceways, ponds, streams, and lakes.
• Sea lice treatments to offshore net-pen salmon. Simulated advective transport, deposition and buildup in sediment of drug using 3-dimensional circulation models.
• Companion animal parasiticides. Calculated risk to aquatic environments resulting from the wash-off of dermally applied flea and tick products from indoor grooming (down-the-drain), outdoor bathing, and swimming. 
• Food Additive Petition (FAP). Prepared environmental assessment of residues in manure, soil, and surface water from additives in livestock and poultry feed. 

As our reliance on veterinary medicines grows, so too does our responsibility to manage their environmental impact. Thoughtful regulation, research, and disposal practices are essential to protect both animal and ecosystem health. At Waterborne, we are committed to guiding the process that we can all move toward more sustainable care for all species.

Figure 1. USDA-CVM environmental impact evaluation process. Source: https://www.fda.gov/animal-veterinary

Figure 2. Daily risk quotient (RQ) indicating aquatic exposure remains below effects threshold. Circles represent daily annual maximum RQ. The red circle is the 90^th centile (1 in 10-year) risk level.