FDA is currently working on finalizing the
Food Safety Modernization Act (FSMA) regulations and has begun public discussions regarding how the Agency plans on implementing these new regulations and what resources will be needed to help government and businesses covered by these new rules understand and implement them. In May 2014, FDA issued a document
outlining FDA strategies for implementing FSMA which includes capacity building, training, and operational plans for the Agency. FDA explicitly states that “food safety depends primarily on the food industry, with top-level management commitment and working in a continuous improvement mode, to:
Implement science- and risk-based preventive measures at all appropriate points across the farm-to-table spectrum, and
Manage their operations and supply chains in a manner that provides documented assurances that appropriate preventive measures are being implemented as a matter of routine practice every day.”
PMA has compiled a
Quick Reference Chart for FSMA compliance dates by regulation and business size.
Visit PMA's FSMA Resource Center for detailed information on each of the FSMA rules and anticipated implementation schedules. PMA activities such as webinars and educational sessions will take place throughout the year to help PMA members identify and prepare for FSMA implementation requirements.
Advocating for Sound FDA FSMA Policy: Seven major implementing regulations of the Food Safety Modernization Act have now been finalized with set compliance dates based on enterprise size. PMA seeks to advocate on behalf of PMA members and influence the U.S. Food and Drug Administration’s (FDA) implementation policy regarding the numerous FSMA regulations to assure that these new regulations achieve their stated food safety objectives and are practical and workable for our industry members to implement.
FSMA Ag Water Compliance Dates: 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 announced and posted on its website a FSMA Ag Water Testing Methods: 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: FDA and their State partners announced they will 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.
State Government Engagement: PMA continues to work with the National Association for State Departments of Agriculture (NASDA) and the Association for Food and Drug Officials (AFDO) as state government agencies will play a significant role in FSMA rule implementation and compliance verification. PMA has strongly advocated on behalf of State agencies to assume this FSMA education, compliance and enforcement role as we believe that State agencies have a better understanding and knowledge of the specific growing and harvesting practices in their areas and many have long standing relationships with produce growers and state/local produce associations.
Congressional Engagement: PMA continues to work closely with Cornerstone Government Affairs regarding appropriate future FDA funding for FSMA implementation, such as the cooperative agreement funds that are discussed above. PMA is strongly advocating that FDA funds be used to assist the produce industry with training to achieve compliance with the new FSMA regulations. PMA staff has also been engaged with the Government Accountability Office (GAO), the research office of the U.S. Congress, which has begun conducting evaluation of how well FDA has evaluated and responded to business concerns expressed by produce growers, packers, distributors, and others affected by the FSMA produce safety rule.
FSMA Education Outreach Leadership: PMA is developing and implementing a comprehensive strategy to help members be aware, understand, implement and verify compliance with the new FSMA regulations. This plan accounts for PMA members’ needs along the entire produce supply chain and collaboratively leverages the efforts of academia, government and allied produce trade associations.
As you can see there is a lot going on regarding FSMA implementation policy and education outreach. The PMA Science & Technology team will continue to be engaged and striving to assure that FSMA implementation policy is sound and practical as well as delivering membership value in year around communications and education outreach, to keep members abreast of important food safety regulatory developments. If you have further questions please do contact any of the members of the PMA Safety and Technology Team Produce Safety team and/or visit the
PMA FSMA homepage.