At the National Association for State Departments of Agriculture Association (NASDA) annual meeting in New Orleans, LA, FDA Commissioner Gottlieb announced significant changes in FDA’s public policy.
The Produce Marketing Association (PMA), in collaboration with other leading produce trade organizations have been strongly advocating that FDA re-open the Food Safety Modernization Act (FSMA) rulemaking process to amend the Produce Safety and the Preventive Controls for Human Foods Rules. Specifically, PMA has been advocating for a re-evaluation of the FDA definition of “farm,” a simplified approach to produce business rule coverage and agricultural water provisions of the FSMA Produce Safety Rule that are both risk and science-based. As such, PMA, in collaboration with other leading produce trade organizations, have advocated for changes to current policies in recent meeting with FDA Commissioner Gottlieb, the White House, the USDA Secretary of Agriculture and the NASDA.
Gottlieb’s announcement is aimed at making the rollout of the FSMA Produce Safety Rule less disruptive to the industry and ultimately to make the regulations more targeted to protecting public health, according to PMA. His speech, in its entirety, can be found here. Specifically, issues of importance to the produce industry are as follows:
- Compliance Dates: On Sept. 12, FDA issued a proposed rule that, if finalized, would extend the compliance dates for the agricultural water provisions of the FSMA Produce Safety Rule by an additional two to four years for produce other than sprouts. The proposed extension is meant to provide FDA with the opportunity to review and revise the FSMA Produce Safety Rule agricultural water standards based on upcoming stakeholder input to ensure that these standards enhance public health and are feasible and practicable for farmers to implement. FDA’s new, proposed agricultural water compliance date for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively. This proposed rule is open for public comment for 60 days. Importantly, FDA does not intend to take action to enforce the agricultural water requirements for produce, other than sprouts, while the rulemaking process is underway. FDA will also be convening an agricultural water summit early next year, as well as soliciting input from stakeholders as how the agency should consider amending the current FSMA Produce Safety Rule agricultural water provisions.
- Testing Methods: FDA announced and posted on its website a list of eight additional agricultural testing methods that the FDA has determined to be equivalent to the required method specified in the FSMA Produce Safety Rule.
Produce farm inspections: Gottlieb also announced that FDA and their State partners will follow through on their promise to educate before and during inspections and as such FDA and States will not begin assessing FDA Produce Safety Rule compliance, with the non-water requirements until Spring 2019. However, farms will still be expected to meet all produce safety requirements set by the rule for produce other than sprouts, except those related to agricultural water, by their original compliance dates. This means January 2018 for the largest produce farms. The FDA and their state partners will use this time to expand the availability of education outreach opportunities called On-Farm Readiness Reviews that have been piloted in six states. On-Farm Readiness Reviews are conducted by a team of state officials, cooperative extension agents, and FDA produce experts that provide farmers with an assessment of their “readiness” to meet the new FSMA Produce Safety rule requirements.
These modifications by FDA along with their commitment to work closely with State Departments of Agriculture on the rollout of the FSMA Produce Safety rule are a significant course correction, according to PMA. The association said the FDA is to be commended for their leadership here and for listening and taking action to enhance public health and to assure a smooth roll out of the new FSMA regulations for produce farms and businesses. Details regarding this major produce safety policy course change can be found on the FDA website here.
If you have any questions regarding these changes, please feel free to reach out to Dr. Jim Gorny, PMA’s Vice President Food Safety and Technology.