Interpreting the “Same Level of Public Health Protection” in Produce Safety Rule Variances

Lauren R. Wustenberg


As the Food Safety Modernization Act Produce Safety Rule (FSMA PSR) enters implementation, regulators and stakeholders are examining their options in case some provisions do not suit their jurisdiction’s circumstances. Under Subpart P, food safety agencies may apply for PSR variances if the agency proposes substitute measures that provide the “same level of public health protection.” Through variances, the Food and Drug Administration (FDA) could regionalize PSR requirements and account for geographic variation in environmental conditions, agricultural practices, and industry technologies. Theoretically, variances can be as simple as an exception from one PSR provision for a single commodity or as complex as a waiver of all PSR requirements for all producers in a foreign country. Draft guidance began illuminating the same level of public health protection standard, but many questions remain unanswered. This Article examines analogous United States Department of Agriculture (USDA) and FDA programs, as well as international trade law, to discern how petitioners can show that substitute measures meet the same level of public health protection standard and how the variance process may differ based on the complexity of the request. After discussing the basic structure of the variance process and the only variance petition submitted to date, this Article examines legal precedent for analogous regulatory evaluation processes. Legal precedent examined includes FDA’s Manufactured Food Regulatory Program Standards, USDA’s Meat & Poultry Inspection equivalence program, and FDA’s foreign systems recognition and foreign equivalence processes. Due to their influence on U.S. import regulation, this Article also examines U.S. obligations under the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (WTO SPS Agreement) to determine whether the PSR is open to challenge as a violation of international trade commitments. FDA should rely upon these analogous processes to inform its evaluation of PSR variance petitions. Doing so will clarify petition requirements, improve procedural efficiency, and help ensure FDA’s consistency when reviewing similar variance requests.