The act primarily addresses regulatory gaps at the FDA and does not place a burden on the states. States are not required to perform any of its provisions nor does the law supersede state law. Food producers and processors will still have to follow state rules in addition to the new FDA requirements. Because the FDA has not promulgated its regulations, no case can be made that their rules conflict with any state rules. There may be a likelihood of duplication of efforts; however, between the state standards and the FDA requirements once the rules are promulgated.
State and local programs are mentioned often in the act. Section 110 of the FSMA requires the FDA to provide outreach to the state and local governments to build their food safety and food defense capabilities, which will include additional resources for state food safety programs. In addition, the FDA must work with states and local health programs to determine the best approach to addressing surveillance and tracing back of foodborne outbreaks.
Section 112, which addresses food allergy and anaphylaxis management, specifically asserts (in § 112(b)(3)) that nothing in that section should be construed to preempt state law.
However, although no specific state requirements exist, the law encourages the FDA to rely heavily on current state food safety and inspection programs, since a majority of the work currently is performed by state agencies. Section 205 (c ) requires the FDA to “develop and implement strategies to leverage and enhance the food safety and defense capacities of state and local agencies” regarding foodborne illness outbreaks, state laboratory capacity, carrying out inspection and enforce safety standards, to share information among agencies, and to improve the effectiveness of federal, state and local partnerships on food safety and defense. Section 209 provides for improving the training of state, local territorial and tribal food safety officials. Section 210 authorizes grants from the FDA to states and local governments to enhance food safety activities, build state laboratory capacities and build the infrastructure of state food safety programs.
Foodborne outbreaks, surveillance and inspection activities, and trace-back efforts all currently reside in the purview of state agencies, though funding often comes from a federal source. In-state sales of food products, such as sales at local farmers markets or other intrastate sales, remain under the purview of state government. Food produced on a farm and sold by the farm directly to a consumer is exempt (§ 204 (d)(6)(H)(I)), meaning any regulation of such activities must be done under state authority.
State departments of health are specifically mentioned. Section 399V-5 establishes Food Safety Integrated Centers of Excellence, which are to be housed in various state departments of health. These centers are to help other states and local departments of health through outbreak surveillance and investigations, analysis of the response, offering epidemiological and environmental training, and training and coordination of state and local agency staff. This effort will enhance state capabilities to identify and respond to a foodborne outbreak, though it will require states to maintain a food safety program within their health departments.
The Food and Drug Administration
The FDA has the primary role in ensuring the nation’s food supply is safe. Through its regulatory authority and extensive contracts with state and local food and health officials, the FDA is responsible for food safety in this country, with the exception of meat, poultry and egg safety requirements handled by the U.S. Department of Agriculture (USDA).
The FSMA provides the FDA with new authorities designed to achieve higher rates of compliance with prevention and risk-based food safety standards. It allows the agency to respond to and contain food safety problems when they arise. The law also directs the FDA to ensure imported foods follow the same standards as foods domestically produced.
Most importantly for states, it directs the FDA to build an integrated national food safety system in partnership with state and local authorities.