University of Maryland Extension

Federal food safety laws

Nicole Cook, B.S., J.D., LL.M., Environmental and Agricultural, Faculty Legal Specialist, Agriculture Law Education Initiative (ALEI), University of Maryland Eastern Shore

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In general, federal regulations apply to all foods that are sold in interstate commerce (meaning across state borders) or foreign commerce, and states have the power to regulate most foods that are only sold intrastate (see “What’s federalism got to do with it?” below for more information about the interplay between federal and state governments). With a number of specific exceptions, the U.S. Food & Drug Administration (FDA) has jurisdiction over processed foods, seafood, and food additives, while the U.S. Department of Agriculture (USDA) regulates fresh produce, livestock, poultry, and eggs. In January 2011, President Obama signed into law the Food Safety Modernization Act (FSMA), which was the first major overhaul to the federal food safety regime since 1938. There are two major parts of FSMA that are particularly important to small and local food producers. First, FSMA increases federal regulatory power over agricultural producers of fruits and vegetables, which were not heavily regulated in the past. The Act does, however, exempt many small-scale producers from most of its regulatory requirements. Agricultural producers who average annual gross produce sales of less than $27,528 over three years are not covered by FSMA’s Produce Safety Rule (PSR). Operations that gross less than $550,551 annually and who sell a majority of their products in direct sales to consumers, restaurants, or retail stores, either within the state or within 275 miles of the farm or production facility, are exempt from the produce safety standards. They must, however, maintain records to support that they qualify for the exclusion or exemption.

Second, under FSMA, facilities that “manufactur[e], process, pack, or hold food” are now required to maintain an extensive hazard analysis and critical control point (HACCP) plan. Small-scale processors and facilities are exempt from the specific hazard control requirements laid out in the statute, and instead must submit modified hazard control plans to the FDA. Similar to the PSR standards, facilities whose operations gross less than $550,551 annually and who sell a majority of their products in direct sales to consumers, restaurants, or retail stores, either within the producing state or within 275 miles of the production facility, are subject to the modified hazard control requirements. In the case of a foodborne illness outbreak or incident involving an exempt facility, the FDA retains the authority to conduct more comprehensive inspections and reinstate some of the standard requirements vis-à-vis that facility.

Note, the above gross sales cutoffs have provisions to adjust for inflation. For updated numbers, see the FDA website:

Information about FSMA and food safety laws is available at


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