In a speech in New Orleans, La., at the annual conference of the National Association of State Departments of Agriculture (NASDA), Food & Drug Administration commissioner Dr. Scott Gottlieb highlighted the forthcoming compliance hurdles facing the food industry in 2018. He announced a decision to emphasize education during the first year of implementation of the Produce Safety Rule under the Food Safety Modernization Act (FSMA), which will give FDA more time to develop guidance and to complete development of regulator training programs for implementing the rule.

Gottlieb said the agency 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, FDA said.

“We’ve committed to rethink certain provisions. We’re pushing back inspections, and we’ve created a structure for continued collaboration,” Gottlieb said in his speech. “I believe the steps I outlined today set all of us up for successful implementation. We need to get this right. We need to get it done.”

Dr. Michael G. Strain, NASDA president and Louisiana commissioner of agriculture and forestry, welcomed the proposed steps and underscored the significance of this critical step to help producers comply with the rules of FSMA prior to implementation.

“We are pleased that states will have more time to deploy educational tools for our producers based on that guidance and to implement the On-Farm Readiness Review Process, which is consistent with the FDA decision to emphasize education. FDA is showing support of an important transition from the reactive programs that have existed in the past to the preventive programs of the future,” Strain said.

Agricultural water compliance dates

FDA 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, FDA said.

The new agricultural water compliance date FDA is proposing for the largest farms is Jan. 26, 2022. Small farms and very small farms would have until Jan. 26, 2023, and Jan. 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.

FDA said it does not intend to take action to enforce the agricultural water requirements for produce other than sprouts while the rule-making 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.

“Extending these compliance dates by an additional two to four years and reviewing testing methods will provide producers with more practical and achievable water quality expectations across our diverse food production landscape. Commissioner Gottlieb’s announcement underscores the growing strength of our cooperative partnership with the FDA. This is an important first step towards feasible water standards for America’s producers,” Strain noted.

Stakeholder engagement

During the additional time that would be afforded by the extended compliance dates, 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 to 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, FDA said.

NASDA and FDA entered into a cooperative agreement in 2014. As a part of that effort, NASDA has developed a Model Produce Safety Implementation Framework for states to use as they implement the Produce Safety Rule. Forty-three states are cooperating with FDA to implement the Produce Safety Rule; FDA has committed $30.9 million for these state programs, which builds on the nearly $22 million FDA awarded last year to 42 states.

The On-Farm Readiness Review program is being developed by NASDA in conjunction with FDA and extension services. It is a voluntary, non-regulatory opportunity to assess a farm’s readiness for FSMA compliance.

Numerous stakeholders have asked for FDA to recognize other methods that are appropriate for use in agricultural water testing. In a recent letter to Western Growers, 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. FDA has posted the list of methods it has determined to be equivalent on its website and said it 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 of the rule for produce other than sprouts -- except those related to agricultural water -- by the original Jan. 26, 2018, compliance date. However, 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.

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 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 Office of Regulatory Affairs, and calls are being scheduled to answer any questions, FDA said.

States will receive information from FDA this week on how existing cooperative agreement funding through the On-Farm Readiness Review program can be reallocated to provide for additional focus on educational and outreach activities in lieu of inspections.

FDA said it 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 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,” FDA said.