Regulatory Program Standards
National Regulatory Program Standards Overview
FDA is committed to building a nationally Integrated Food Safety System (IFSS) of high quality regulatory programs responsible for protecting public health from human and animal foodborne illness and injury. Regulatory program standards play a critical role in an integrated food safety system and serve as the foundation for mutual reliance between agencies working with one another.
Regulatory program standards establish a uniform foundation for the design and management of state, local, tribal, and territorial programs that have the responsibility for regulating human and animal food.
The standards framework is comprised of best practices related to prevention, intervention and response activities. Human and animal food regulatory programs can use the framework to build, maintain, evaluate and continuously improve their operations in a methodical and systematic manner to ensure high quality services and products for their customers.
FDA has collaborated with local and state partners and their associations to develop three sets of standards to date for manufactured food, animal feed, and retail food regulatory programs. FDA is also using a similar systems-based approach for establishing reciprocity with other countries looking to export food to the US.
FDA continues to collaborate with our partners and to support the development and use of regulatory program standards to:
- Encourage the adoption of the most current, science-based human and animal food laws and regulations necessary to protect public health.
- Promote the development of training programs to ensure that regulatory staff have competencies needed to effectively carry out their work.
- Help programs to develop risk-based inspection and sampling protocols to ensure effectiveness and efficiency.
- Provide a mechanism to evaluate and communicate the quality of their inspections and sampling to ensure desired outcomes in alignment with their policies and procedures.
- Support the development of a food and feed emergency response program that is based on nationally recognized best practices designed to identify, stop, control and prevent hazards that are likely to result in a human or animal foodborne illness, injury or outbreak.
- Ensure that regulatory programs have and use strategies and enforcement procedures when necessary to ensure compliance with their jurisdiction’s laws and regulations to protect public health.
- Encourage the use of education and outreach with stakeholders to address human and animal food safety and inspection-related issues.
- Help programs to self-assess and allocate resources needed to support effective and efficient operations related to prevention, intervention and response activities.
- Re-enforce management’s commitment to implement a quality system for continuous improvement of their program’s products and services.
- Provide management with a tool to assess and collaborate with their laboratory partners for human and animal food testing services needed to support their program inspection, investigation and enforcement activities.