February 6, 2020
Nearly ten years after the passage of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) is still issuing new rules. With the temporary lull in FSMA-related policy activity coming to an end, there will be renewed need for public action on FSMA rulemakings once they are issued later this year. In 2020, at least two proposed FDA rules will require advocates’ attention: the Additional Recordkeeping Requirements for High Risk Foods (“High Risk Foods rule”) and the revisions to the Agricultural Water Requirements within the Produce Safety Rule.
Small farm FMSA inspections also start this year, meaning input from farmers and other concerned advocates is more important now than ever. The National Sustainable Agriculture Coalition (NSAC) has been a leading advocate for FSMA-related rules and protocols that ensure a flexible and realistic approach to regulation that is appropriate for farms and food businesses of all sizes. Once the new FSMA rulemakings are published, NSAC will issue additional information on ways to take action and make your voice heard. For more information on Produce Safety Rule inspections on farms, visit our “Inspection Preview” post.
FSMA requires FDA to issue a proposed rulemaking establishing additional recordkeeping requirements for any entity that manufactures, processes, packs, or holds foods that FDA determines to be “high risk.” FDA is now under a court ordered mandate to issue a proposed High Risk Foods rule for public comment by September 8, 2020. FSMA also requires FDA to host three public meetings to gather input from stakeholders across the U.S.
NSAC encourages farmers and farm advocates to submit comments on the proposed High Risk Foods rule once released.
Fortunately, FSMA language around the High Risk Foods rule includes a number of exceptions for farms. Farms are not required to keep records if the high risk food is produced on that farm and sold directly to a consumer or grocery store, for example. FSMA also provides exceptions for grocery stores that purchase directly from farms to ensure this new rule does not create a barrier to market access for small and medium sized farms.
There is also an exemption for any high-risk food that preserves the identity of the food, and for the farm that produced and packaged the food. The label must include the complete name, address, and business phone number of the farm to meet this exemption.
As FDA writes the proposed High Risk Foods rule, they must take into consideration the impact the rule could have on local or direct-marketed food products, and on farms and food businesses of all sizes. NSAC submitted comments at the end of last year on FDA’s New Era of Smarter Food Safety to highlight several key points to be considered as FDA write this new rule.
The New Era of Smarter Food Safety questions on which FDA requested comment hint at what the agency might be considering for the new proposed High Risk Foods rule. For example, FDA requested comments on what might incentivize the adoption of real-time, end-to-end food traceability throughout the food supply chain. Financial costs were discussed, but NSAC encouraged FDA to also consider several additional issues, including the fact that many farms and rural areas lack internet or cell service. NSAC also underscored that many of these same producers and communities lack adequate market access and pointed out that existing traceability technologies are not built to support small, direct-market farm operations.
After officially delaying the Produce Safety Rule Agricultural Water Requirements last year, FDA announced in early January 2020 that they hope to issue a new proposed rule by the end of the year.
Many farmers were critical of the The Agricultural Water Requirements section of the Produce Safety Rule. The costly, complicated, and flawed water testing mechanisms made many produce farmers apprehensive about the impact this rule could have on their operations, including concerns about small farms paying disproportionate compliance costs. NSAC has urged FDA to ensure that the new proposed rule includes a reasonable, science, and risk-based approach to agricultural water that allows farmers to respond to risks that may come from their water systems.
FDA had also previously halted enforcement efforts around businesses that may be covered by the Preventive Controls Rule for Human Food, but conduct activities similar to “farms” covered by the Produce Safety Rule. FDA is revisiting how these similar activities can be covered by one rule, regardless of whether the business falls within the FDA’s definition of a “farm.” It is possible a proposed rule on this topic, which might include edits to the farm definition, could be released in 2020. NSAC has several resources that explain FDA’s farm definition on our website.
The U.S. Department of Agriculture’s Rural Development Rural Business-Cooperative Service also plans to release an interim final rule in the first half of 2020: the Value Added Produce Grants’ (VAPG) new food safety provisions. Farms and food businesses that seek a simple grant option, where they can receive a small amount of money to upgrade food safety practices and equipment, should comment on this rule to ensure the option is accessible and covers their food safety needs.