In-Depth Legal Analysis

Planting the Seed: A Proposal for a Farm Operation Test Under the FSMA Produce Safety Rule

Congress enacted the Food Safety Modernization Act (“FSMA”) in 2011 and the Produce Safety Rule (“PSR”) in 2015, yet the classification of multiple farm enterprises remains unsettled. Farmers with smaller-scale diversified farms consequently straddle the line between fully covered and qualified exempt under the PSR. In this Article, Sophia Kruszewski & Samuel Ingraham propose a standardized farm operation test that all farmers and PSR regulators could utilize when determining the coverage status of a farm with multiple enterprises.

This journal article compliments:

FSMA PSR Coverage and Exemptions for Farms with Multiple Business Entities

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

Under Subpart P of the Food Safety Modernization Act Produce Safety Rule, food safety agencies may apply for PSR variances if the agency proposes substitute measures that provide the “same level of public health protection.” In this article, Lauren Wustenberg 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.

This article was originally published in the Food and Drug Law Journal and is shared with permission of the Food and Drug Law Institute.

The journal article compliments:

Alternatives and Variances to the Produce Safety Rule

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