Crop grouping: a proposal for public aquaculture

Area of Science:

• Aquatic pharmacology and toxicology
• Fish health management
• Regulatory science

Background:

• US aquaculture faces limitations due to a scarcity of FDA-approved drugs.
• Extending drug labels to new fish species is costly and time-consuming.
• Existing drug approval processes are resource-intensive.

Purpose of the Study:

• To propose and evaluate an FDA-sanctioned crop grouping plan for fish drug approvals.
• To reduce the financial and temporal burdens of drug label expansion in aquaculture.
• To ensure regulatory safeguards for human food safety and environmental protection.

Main Methods:

• Developing a database sensitive to inter- and intra-species differences.
• Grouping candidate fish species based on temperature preference, activity level, and phylogeny.
• Testing surrogate species (rainbow trout, channel catfish) and additional groups (sturgeon, striped bass, walleye).
• Administering waterborne (benzocaine) and oral (sarafloxacin) drugs to assess response variability.

Main Results:

• Comparing drug response variability between major species and within cohort species to test group integrity.
• Establishing a framework for grouping fish species for regulatory drug approval.
• Demonstrating the potential for surrogate species to represent broader fish groups.

Conclusions:

• A well-designed crop grouping plan can significantly improve drug approval efficiency in aquaculture.
• This strategy conserves public resources while maintaining regulatory oversight.
• Data-driven grouping based on biological and environmental factors is crucial for plan success.