The Food Safety Modernization Act (FSMA) became law in 2011 in an effort to address rapid changes in the food system and to prevent foodborne illnesses. The stated goals of the FSMA are to improve public health by reducing foodborne illnesses and promote a shift in the entire food system wherein the food industry takes a leadership role in adopting innovative preventative practices. The FSMA also changes the way the Food and Drug Administration (FDA) works. Instead of simply responding to foodborne illnesses, it now seeks to prevent them using improved screening, education, assessment, data collection, enforcement and other tools.
There are categories of rules in the FSMA that apply to food transportation, imports of food, and the manufacture and processing of human or animal food. Some of these categories generally do not apply to Farm-to-Consumer Legal Defense Fund (FTCLDF) members. For example, unless you are a registered food business per the Food, Drug and Cosmetic Act, farms (and certain food manufacturing, processing and holding activities conducted on farms) are generally exempt from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food requirements of the FSMA. This article will, therefore, focus on the aspects of the FSMA most relevant to farms we assist: the Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, or the “Produce Safety Rules.” FTCLDF offers other resources to members looking for help with custom slaughter and processing of livestock.
The FSMA standards were structured to roll out in phases and the largest businesses were the first required to meet deadlines by which they must adopt certain food safety practices, followed by the smaller players. We will focus here on small and very small producers, which make up the bulk of the FTCLDF membership, and highlight the rules under FSMA that apply to them and the deadlines by which they must be in compliance.
Definition of Farms
Before we examine the rules, let us pause for a minute to look at how farms are defined under the Produce Safety Rules. While the FDA is currently working on revising the definitions, it intends to exercise “enforcement discretion” while those revisions are finalized, so farmers should familiarize themselves with the classifications. FSMA defines two types: “primary production farms” and “secondary activities farms.” Primary production farms are defined as those that operate under one management in one location and grow and/or harvest crops and/or raise animals. They also may perform some packing, holding, processing and manufacturing activities (which can include drying and rehydrating, treating to ripen, or packaging and labelling raw products—fruit is one example). Secondary activity farms are not located on primary production farms but are majority owned by them and their main focus is to harvest, pack and/or hold the raw products that the primary facility grows, harvests, and/or raises. Secondary activity farms are subject to more rules and enforcement than primary production farms.
Potential Exemptions to the FSMA Produce Safety Rules
The Produce Safety provisions have a number of exemptions under which our members may fall. For example, if a farmer grows produce that is rarely eaten raw, it may be exempt from the safety provisions. Such items generally include asparagus, beans, pumpkins, winter squash, and grains. A full list of these exempted items can be found in this FDA guidance document for small entities (see page 10). A list of the produce covered by the rules can be viewed in the same document on page 7.
Farms selling less than $25,000 annually in produce
There are other exemptions that are important to highlight up front that may remove many of our farm members from the compliance requirements. First, the Produce Safety Rules do not apply to farms that sell on average less than $25,000 a year in produce, or where the produce is for personal/on-farm consumption only.
Farms selling less than $500,000 directly to consumers and local businesses
Second, farms that sell on average less than $500,000 a year in food directly to consumers of the food and to certain local businesses (e.g. restaurants and retailers) may be eligible for exemptions under which modified requirements are to be met. Those who run farm stands or sell produce to food establishments in the same state or not more than 275 miles away can benefit from these exemptions.
Farms producing product for commercial processing
Farms may also be eligible for exemption, subject to certain written assurances and documentation, for produce that receives commercial processing (designed to reduce harmful microorganisms).
This FDA chart will help our producer members determine whether they fall into the primary production farm or secondary activities farm definition, and how the rules may or may not apply to them.
FSMA Produce Safety Rules
For those businesses that don’t qualify under the above exemptions, the compliance dates for farms growing and harvesting fruits and vegetables that sold produce during the previous 3-year period valued at more than $500,000 was January 2018; for those averaging $250,000-$500,000 a year in sales (“small businesses”), the date was January 2019; and for those averaging sales between $25,000 but not more than $250,000 (“very small businesses”), the compliance date was this past January 2020. At this time, unless farms fall under one of the above exemptions, they should now be compliance with the FSMA Produce Safety Rules. (Be aware that sprouts have separate, earlier compliance dates.)
The goal of the Produce Safety Rules according to the FDA is to use “science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.” So for entities that are covered under the rules, the requirements to be met involve:
- training personnel who handle/harvest produce or food contact surfaces in proper food safety practices;
- establishing hygienic practices to prevent contamination;
- meeting the requirements for the use of manure and other biological soil amendments of animal or human waste origin;
- preventing contamination of produce by grazing animals/livestock and working farm animals, and identifying and not harvesting any such contaminated produce;
- separating produce covered under these rules from excluded produce that is not grown, harvested, packed or held in the same way;
- ensuring that farm equipment, tools, and buildings are designed, handled and cleaned in a manner that prevents them from contaminating produce; and
- meeting certain record keeping requirements.
Another requirement involves microbial testing for agricultural water. However, because the rules are so complex, the FDA was compelled to extend the compliance dates to January 2022 for large businesses, January 2023 for small businesses, and January 2024 for very small businesses. Again, earlier dates still apply for sprout growing. While FTCLDF members likely have a bit of time, they should consider practices needed to comply with rules. The FDA offers this guide to producers.
It is also helpful to note that the FDA has indicated that it will use “enforcement discretion” regarding certain sections of the FSMA, including where the Produce Safety Rules require certain written assurances about the process for controlling hazards. This means that, until further notice, they will not be enforcing these provisions.
There are a number of helpful resources to help with the details of compliance. The Produce Safety Alliance is an excellent resource for those looking for additional insight. In addition, On-Farm Readiness Reviews is a voluntary program to which farmers can apply in which FDA regulators and educators come on site and offer guidance and assistance. There are also farmer self-assessment tools being developed for those who want to check their readiness on their own before a potential visit. The Produce Safety Network has also been developed to assist farmers, state regulators and others on how best to implement the Produce Safety Rules.
It remains unclear at this time how COVID-19 may impact the FSMA rules, compliance dates, and enforcement. FTCLDF will continue to monitor developments and keep our members informed as we learn of changes or additional helpful resources we can share.
YOUR FUND AT WORK
Services provided by FTCLDF go beyond legal representation for members in court cases.
Educational and policy work also provide an avenue for FTCLDF to build grassroots activism to create the most favorable regulatory climate possible. In addition to advising on bill language, FTCLDF supports favorable legislation via action alerts and social media outreach.