Background Information

The purpose of the Center for Veterinary Medicine (CVM) Aquaculture Strategic Plan is to identify the top aquaculture priorities for CVM to advance over fiscal years 2022-2026.

The strategic plan identifies where effort and resources should be directed, leverages expectations, and unifies CVM’s approach across offices. It involves offices across CVM, including the Office of Minor Use Minor Species (OMUMS), Office of Research (OR), Office of Surveillance and Compliance (OSC), Office of New Animal Drug Evaluation (ONADE), and Office of the Director (OD).

The strategic plan incorporates aquaculture-related projects already underway at CVM, as well as identifies new initiatives and activities.  Many of these are dependent on availability of internal and/or external resources.  The strategic plan is also intended to support the National Strategic Plan for Aquaculture Research and Strategic Plan to Advance Regulatory Efficiency in Aquaculture.

Vision and Mission

Vision

To have an efficient, innovative, transparent, and responsive system that ensures access to safe and effective products for all sectors of aquaculture, and advances productivity, animal health, and food safety.

Mission

The mission of the Center for Veterinary Medicine (CVM) is to protect U.S. human and animal health by assuring the safety and effectiveness of animal drugs, including drugs intended for food producing animals, and the safety of animal foods.

CVM’s aquaculture strategic plan supports the protection of public and animal health by ensuring the availability of food and drugs for aquatic animals that are safe and effective. Through this plan, CVM will develop and evaluate scientific and regulatory approaches that consider the unique needs of aquatic animals and aquaculture production systems, while also meeting the requirements of the Federal Food, Drug, and Cosmetic Act. These approaches will provide the aquaculture industry with tools to protect aquatic animal health as well as public health. 

Strategic Goals, Objectives, and Actions

The CVM Aquaculture Strategic Plan is comprised of three strategic goals. These goals will direct CVM’s work during FY 2022-2026 and are dependent on the availability of resources. 

Strategic Goal 1: Increase the number of safe and effective products for aquaculture

Objective 1.1: Explore ways to make the product evaluation process more flexible, efficient, and innovative

• Investigate aspects of the Veterinary Innovation Program (VIP) and other approaches to facilitate the development of aquaculture products
• Leverage real world data, publicly available data, and data from international approvals

Objective 1.2: Develop a framework with our external partners to support aquaculture product development

• Create a comprehensive aquaculture research plan and identify internal and external research capabilities
• Advance coordination of efforts of all partners engaged in the development of aquaculture products
• Continue to encourage extramural research efforts and explore potential for an aquaculture regulatory research consortium

Objective 1.3: Enhance communication with stakeholders involved in product development

• Explore ways to increase communication and transparency between CVM and stakeholders
• Expand collaboration with domestic and international regulatory bodies
• Develop novel approaches for outreach that encourage education and growth
• Identify and communicate requirements for aquaculture products

Objective 1.4: Explore new regulatory solutions for aquaculture products

• Investigate new incentives or refine current incentives for Minor Use Minor Species (MUMS) drugs
• Consider expanding indexing eligibility

Strategic Goal 2: Encourage responsible use of aquaculture products

Objective 2.1: Improve aquatic drug stewardship through outreach, education, and research

• Organize/participate in trainings on legal aquaculture products and drug susceptibility testing
• Develop outreach and educational resources on antimicrobial stewardship and the proper use of aquaculture products
• Continue collaborating with the Clinical Laboratory Standards Institute to standardize antimicrobial susceptibility testing for aquatic bacteria and develop criteria for monitoring antimicrobial resistance

Objective 2.2: Enforcement of unapproved products marketed for aquaculture

• Prioritize enforcement efforts including review of the CVM Program Policy and Procedures Manual 1240.4200 Enforcement Priorities for Drug Use in Aquaculture
• Continue collaborating with USDA and other agencies on food safety surveillance to develop validated chemical methods and provide input on target testing levels and drug residue tolerances

Objective 2.3: Promote collection and usage of post-market data for aquaculture products

• Educate stakeholders about reporting of adverse drug events to CVM
• Explore novel ways to analyze adverse drug event reports for indexed drugs
• Improve monitoring of aquaculture product safety leveraging CVM’s adverse drug event database

Strategic Goal 3: Enhance internal and external collaboration

Objective 3.1: Facilitate collaboration between all offices in CVM on aquaculture policy and initiatives

• Leverage internal expertise across the Center
• Collaborate, problem-solve, and work toward common goals across offices in CVM
• Increase information sharing and coordination on aquaculture topics across offices to provide a unified voice to stakeholders

Objective 3.2: Advance external partnerships

• Strengthen existing partnerships with domestic stakeholders and international collaborators
• Build new domestic and international partnerships
• Conduct educational outreach

Objective 3.3: Improve our understanding of factors affecting US aquaculture

• Engage stakeholders to clarify their needs, goals, and constraints, including economics
• Develop potential solutions to challenges identified by stakeholders in public comments on CVM policy and regulation

Objective 3.4: Develop a comprehensive aquaculture research plan

• Identify and prioritize research needs to inform CVM Office of Research activities and external research activities