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Background
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The Northeast Center to Advance Food Safety at the University of Vermont and the Center for Agriculture and Food Systems at Vermont Law School are pleased to share legal educational factsheets as an output of their joint project, the Extension Legal Services Initiative. This initiative identified, researched, and developed educational resources related to key legal questions associated with the FSMA Produce Safety Rule. This project began in late 2018 with a national survey of the produce community to identify and prioritize legal research questions.
- Intended Use and Audience
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Intended Use
These resources are intended to serve as stand-alone and self-contained documents. However, the resources may cross-reference other project resources when the topic of one informs or duplicates information contained in another. When using these resources, we recommend reviewing all cross-referenced resources together. Each resource is marked with the date it was created. This date will change when updates or other changes are made to the document. The educational resources are not intended to provide, nor should they be construed as providing, legal advice. Any information presented therein is purely for educational purposes. If you seek legal advice, please consult an attorney licensed in your state for assistance.
Intended Audience
These educational resources are primarily intended for educators, regulators, and technical service providers that work with produce growers. The resources are also designed and intended to be accessed directly by producers and, for select resources, processors or produce buyers. Educators, regulators and technical service providers are encouraged to share these resources with producers and processers as appropriate. It is assumed that the user of these resources has a baseline understanding of the Food Safety Modernization Act Produce Safety Rule and, for select resources, the Preventive Controls Rule for Human Food.
- Acknowledgments
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The Extension Legal Services Initiative is a collaborative effort between the Northeast Center to Advance for Safety (NECAFS) and Vermont Law School’s Center for Agriculture and Food Systems (CAFS).
About NECAFS
NECAFS, housed at the University of Vermont Extension, is one of four USDA funded regional centers tasked with coordinating training, education and outreach related to the FSMA Produce Safety Rule (PSR) and the FSMA Preventive Controls for Human Foods (PCHF) Rule. NECAFS’ work focuses on coordination and facilitation of the Northeast regional network to support a national food safety training, education, extension, outreach, and technical assistance system among small and medium-sized producers and small processors.
About CAFS
CAFS trains law and policy students to develop real-world solutions for a more sustainable and just food system. CAFS educates students at Vermont Law School through a comprehensive array of residential and online courses, as well as through the Food and Agriculture Clinic. Students can choose to specialize in Food and Agriculture Law; pursue a JD Certificate in Food and Agriculture Law; or earn a Master's or LLM degree in Food and Agricultural Law and Policy. With CAFS's diverse course offerings, degree options, and practical experiences in the clinic, students explore food and agricultural law from a variety of perspectives.
CAFS is also a center for research and advocacy. As a clinician in the Food and Agriculture Clinic or through our Research Assistant and Summer Honors Internship programs, students work with local, regional, national, and international partners, engaging in law and policy work that addresses food systems challenges related to the environment, public health, the economy, food security, and animal welfare. The legal tools and policy recommendations they develop have real-world implications for stakeholders across the food system, including farmers, food producers, entrepreneurs, distributors, consumers, legislators, and administrators
The project has been led by Elizabeth Newbold at NECAFS and Sophia Kruszewski at CAFS, with support from Chris Callahan at NECAFS and Laurie Beyranevand, Lihlani Nelson, and Claire Child at CAFS.
We are grateful for the time and expertise of the ELSI Project Advisors:
- Angela Shaw, Associate Professor and Extension Specialist of Food Microbiology/Safety at Iowa State University
- Mike Mosher, Outreach and Compliance Specialist at the Wisconsin Department of Agriculture, Trade & Consumer Protection
- Lisa McKeag, Extension Educator at UMass Extension Vegetable Program Center for Agriculture, Food and the Environment
- Andre Cantelmo, Co-founder of Heron Pond Farm in South Hampton, NH
- Robert Sakata, Owner of Sakata Farms in Brighton, CO
- Roland McReynolds, Executive Director of Carolina Farm Stewardship Association
- Barrett Vaughn, Assistant Professor in Agricultural and Biological Engineering at Tuskegee University
- Gretchen Wall, Coordinator & Northeast Regional Extension Associate with the Produce Safety Alliance at Cornell University
- Kelly Nuckolls, Policy Specialist at the National Sustainable Agriculture Coalition
- Lauren Handel, Principal Attorney at Handel Food Law, LLC
- Abbey Willard, Director of Agriculture Development Division at Vermont Agency of Agriculture, Food, and Markets
- Trevor Suslow, Vice President of Produce Safety at the Produce Marketing Association
- Atina Diffley, Owner and Consultant at Organic Farming Works, LLC.
- Socrates Trujillo, served when he was a Consumer Safety Officer in the Produce Safety Network at Center for Food Safety and Applied Nutrition at the FDA
- Leanne Skelton, served when she was the Liaison to FDA on FSMA-related issues at the USDA Agricultural Marketing Service, Specialty Crops Program
- Tricia Kovacs, Deputy Administrator in Transportation & Marketing at the USDA Agricultural Marketing Service
- Diane Ducharme, Consumer Safety Officer in the Produce Safety Network at Center for Food Safety and Applied Nutrition at the FDA
We also thank the following Center for Agriculture and Food Systems student clinicians and interns who contributed significantly to the research, writing, and analysis contained in the project resources:
- Sedona Chavez, JD ‘20
- Bethany Towne, JD ‘20
- Ella Farago, JD ‘20
- Lexi Basile, MFALP ‘19
- Samuel Ingraham, JD ‘20
- Lizzie Fainberg, JD/MFALP ‘20
- Lauren Wustenberg, JD/MFALP ‘21
- Lindsay De May, JD/MFALP ‘21
- Jessica Griswold, JD ‘21
- Jessie Gittemeier, JD ‘21 (Lewis & Clark)
Factsheets designed by Kelly Collar, Mad River Creative
Web design by Pete Land, Tamarack Media Cooperative
Select Photos by Andrew Chamberlin, UVM Extension
This project is funded by the National Agricultural Library, Agricultural Research Service, U.S. Department of Agriculture
Food Safety Modernization Act Resources
The Food Safety Modernization Act’s Produce Safety Rule (FSMA PSR) requires an increased level of cooperation between federal and state agencies. States have assessed their produce landscape and established produce safety programs best suited to their individual needs. Therefore, the regulatory oversight, the responsibility for enforcing, and the enforcement approach varies by state.
Developed by the Artisan Grain Collaborative and Vermont Law School’s Center for Agriculture and Food Systems, “Understanding FSMA's Preventive Controls Rule: A Guide for Grain Businesses” empowers grain farmers, processors, and food manufacturers to understand and comply with federal food safety laws. This resource will help food-grade grain farms and food businesses understand if and how the Food Safety Modernization Act Preventive Controls Rule for Human Food Rule (PCR) impacts their operation. Whether or not a business needs to comply with the PCR depends on its activities and size. This factsheet contains a flowchart that helps identify the likely PCR compliance category for a given farm or food business.
The FDA releases information about the FSMA Produce Safety Rule (PSR) in different forms that range from the codified rule to verbal assistance. Producers are unsure of the legal effect of these forms of communication, when they are required or recommended, and their influence during an inspection or in court. This factsheet outlines these communications and explains whether they are legally binding and when producers must follow them.
There is interest in exploring and developing alternatives and/or variances to the Produce Safety Rule (PSR) to address unique or relevant attributes at the state or regional level. As a result, there is a need to understand the process required for an entity or individual exploring these options. This factsheet describes the FSMA PSR provisions that an alternative or a variance would apply to, who is eligible to develop an alternative or variance, the approval process for both, and the high burden of supporting either an alternative or a variance with credible scientific and technical evidence.
The legal research conducted to inform the educational factsheets found on this site also informed the publication of legal journal articles on various FSMA PSR topics. Journal articles include "Planting the Seed: A Proposal for a Farm Operation Test Under the FSMA Produce Safety Rule" by Sophia Kruszewski & Samuel Ingraham and "Interpreting the "Same Level of Public Health Protection" in Produce Safety Rule Variances" by Lauren Wustenberg.
The existence of separate legal business entities for different aspects of a farm's operation may affect the farm's eligibility for an exemption under the FSMA Produce Safety Rule (FSMA PSR). However, forming two separate entities on paper alone is likely not sufficient to establish separate operations for purposes of exemption eligibility.
This factsheet helps illustrate the specifics of each state’s individual produce safety program by summarizing some of the information found on the FSMA PSR State Implementation interactive map on this website. Readers of this factsheet are encouraged to visit the FSMA PSR State Implementation interactive map for additional and up-to-date information.
It can be confusing to determine when a FSMA rule applies to food hubs, produce auctions, and produce brokers. Ultimately, categorizing these produce market intermediaries as farms, facilities, or retail food establishments depends on the specific details of each business. This factsheet identifies several factors for market intermediaries to consider in making this determination.
Farms are impacted by a variety of state and federal laws. Compliance with these other laws should not make compliance with the FSMA PSR more difficult and may in some cases make compliance easier where requirements overlap. This factsheet discusses four federal laws where overlap is possible.
Members of the produce community have expressed interest in accessing the questions and answers submitted through FDA’s Technical Assistance Network (TAN). This desire is based on the assumption that having access to these questions and answers would provide helpful information to the community as a whole, since the content is likely relevant to more than just the individual person submitting the question. This factsheet explains how privacy concerns may limit FDA’s ability to release TAN questions and answers. However, if a person wants to access this information, they can ask the FDA to release it through a FOIA request. This factsheet outlines the process for submitting a FOIA request to the FDA.
A common misconception is that FSMA created liability for producers that did not previously exist. Another common and related question is whether or not compliance with FSMA protects a producer from liability. This factsheet emphasizes that producers have long been subject to liability laws, outlines the nuance that FSMA adds to that existing liability, and covers how compliance with FSMA can be helpful in the event of a lawsuit.
This factsheet explains which processing facilities must comply with the FSMA PCHF supply chain requirements. For those facilities that must have a supply chain program in place, the factsheet describes the steps they must take to approve produce farms as suppliers, including the alternative options available to processors sourcing from exempt and qualified exempt farms and from qualified farm mixed-type facilities.
Produce safety inspections and audits can look similar in practice, which can lead to misunderstandings about the distinct purposes they serve. As a result, it is commonly asked why a grower may need to complete both an audit and an inspection. This factsheet describes the history and differences between an audit and an inspection.
