September 12, 2017
FDA Commissioner Scott Gottlieb, M.D., today outlined a number of immediate next steps in a comprehensive approach to ensuring successful implementation of the Produce Safety Rule established by the FDA Food Safety Modernization Act (FSMA).
In a speech in New Orleans at the annual conference of the National Association of State Departments of Agriculture (NASDA), Dr. Gottlieb announced that the agency has recognized a need for additional efforts to educate the produce industry and state regulatory partners on the new produce safety requirements, and will continue its focus on training, guidance development, and outreach over the next year. This is particularly important since the nation’s farming community has not previously been subject to this kind of oversight.
Dr. Gottlieb also announced steps the FDA will be taking to address concerns related to the complexity and feasibility of implementing standards for agricultural water.
The next steps include the following:
Agricultural Water Compliance Dates: The FDA today issued a proposed rule that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts). The proposed extension will give the agency time to take another look at the water standards to ensure that they are feasible for farmers in all regions of the country, while protecting public health. The new agricultural water compliance date the FDA is proposing 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. The proposed rule is open for public comment for 60 days.
(The proposed extension would also simplify the compliance framework to give all of the water requirements a four-year delay compared to farms’ primary compliance dates. The produce rule now includes a delay of two years in the compliance dates for certain agricultural water requirements, but for others there is no delay.)
The FDA does not intend to take action to enforce the agricultural water requirements for produce other than sprouts while the rulemaking to extend the compliance dates is underway. Sprouts, because of their unique vulnerability to contamination, remain subject to applicable agricultural water requirements in the final rule and their original compliance dates.
Stakeholder Engagement on Agricultural Water Standards: During the additional time that would be afforded by the extended compliance dates, the FDA plans to engage with stakeholders to learn more from farmers, state regulatory partners and other stakeholders about the diverse ways water is used and ensure that the standards will be as practical and effective as possible for all farming operations. This will include a summit on agricultural water early next year -- we will have more information on this later in the year.
Water Testing Methods: In a recent letter to Western Growers, the FDA listed eight additional testing methods from the U.S. Environmental Protection Agency and other public health entities that it has determined are equivalent to the method incorporated by reference (Method 1603) in the Produce Safety Rule. Numerous stakeholders have asked for the FDA to recognize other methods that are appropriate for use in agricultural water testing. The FDA has posted the list of methods it has determined to be equivalent on its website, and intends to add other methods to the list as they are identified.
Produce Farm Inspections: Large farming operations 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 the original January 26, 2018 compliance date. However, Dr. Gottlieb announced that inspections to assess compliance with the non-water requirements of the Produce Safety Rule for produce other than sprouts will not begin until 2019. The FDA and its state partners will use this time to provide more education, training and outreach on the new requirements. In particular, states -- in conjunction with NASDA and the FDA -- will expand On-Farm Readiness Reviews, already piloted in six states, in which a team of state officials, cooperative extension agents, and FDA produce experts provide farmers with an assessment of their “readiness” to meet the new requirements. State points of contact will receive further information on the change this week in the form of letters from the FDA’s Office of Regulatory Affairs and calls are being scheduled to answer any questions.
Earlier this year, the FDA awarded more than $30 million to support 43 states in their development of produce safety programs. This builds on the nearly $22 million that the FDA awarded last year to 42 states. States will receive information from the FDA this week on how existing cooperative agreement funding can be reallocated to provide for additional focus on educational and outreach activities in lieu of inspections.
Training Opportunities for Producers and Regulators: The FDA remains committed to ensuring that produce farmers and state regulators have the training needed to implement the Produce Safety Rule. Training of state regulators will be a top priority for the FDA in 2018, and additional details on training opportunities and other FSMA related training courses will be provided at a webinar being scheduled for October. The agency is committed to working in partnership with farmers and the states, particularly over the next year, to ensure that the fruits and vegetables we serve our families are safe and that consumers have the greatest possible confidence in the produce they consume.
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