With the Produce Safety Rule of the Food Safety Modernization Act (FSMA) now in effect for many produce growers, the last few months have seen a number of updates and communications from the U.S. Food & Drug Administration (FDA). The following is an overview of some of the most significant ones and what they mean to growers.
As of Jan. 26, the first general compliance date of the Produce Safety Rule (PSR) took effect — are you ready? If not, take heart. Not only do small and very small establishments still have a year or two (respectively) to comply, but the FDA is giving all produce growers a bit of a reprieve — committing to a program to “educate before and while we regulate,” as it has done with other rules of FSMA.
This means that the FDA will not begin PSR inspections until 2019, instead conducting On-Farm Readiness Reviews. This enables growers to have their operations and practices assessed for compliance and take corrective action before being held to regulatory action of non-compliance. With the rule establishing enforceable safety standards for the production and harvesting of produce for the first time, the FDA recognizes that growers have not previously been subject to such oversight. This does not mean that growers won’t be expected to meet produce safety requirements, but the FDA will use the extended compliance time to provide training and develop guidance development and outreach.
In September 2017, the FDA also proposed a rule that would extend the compliance dates for the agricultural water requirements by two to four years for produce other than sprouts. The extension was proposed to allow time for the FDA to review and revise the standards to increase the feasibility and practicability for farmers, while still ensuring public health.
Not only does the rule bring new federal standards to growers, it extends FDA’s regulatory responsibility in a new direction. That is, prior to FSMA, FDA was not responsible for the inspection of farms, including the 8,750 greenhouse vegetable and 673 greenhouse fruit and berry growers (according to the latest USDA Census of Agriculture in 2012). This fact, along with other FSMA-increased inspection responsibility for domestic and foreign food facilities, means stretching the already resource-limited agency beyond its limits.
To alleviate this resource shortage, the FDA has partnered with the states in various ways to incorporate their on-farm expertise. A first collaboration was developed soon after the issuance of the PSR final rule in 2015: the Produce Safety Network. This network of produce safety experts, located throughout the country and coordinated by the FDA, was created to enable focus on the diversity of state and regional growing practices while ensuring consistency where appropriate.
The FDA also has been working with the National Association of State Departments of Agriculture (NASDA). Not only is NASDA helping plan and carry out implementation of the rule, but growers can expect to see state representatives with or instead of FDA investigators on the readiness reviews and inspections.
“FDA has long held that state partnerships are necessary to help the food industry understand and achieve the new requirements of FSMA, particularly for the Produce Safety Rule,” said David Acheson, president of The Acheson Group and former FDA associate commissioner of foods. “This is primarily because the states have a long history of successfully working with their farming communities,” he said.
While the FDA’s inspection reprieve and state partnerships are assisting in the general roll-out of the new requirements, growers are likely to also have very specific and individual questions and needs. It was for just such questions that the FDA introduced the Technical Assistance Network (TAN), an online resource for inquiries related to the FSMA rules, programs and implementation strategies.
Along with a link through which questions can be asked, the TAN website includes answers to common questions submitted through the network and FDA-developed FAQ pages. Both are grouped by topic. The questions submitted to TAN are answered by FDA information specialists or subject matter experts, “based on the complexity of the question,” the site states. While the agency commits to responding to inquiries as soon as possible, it also states that “response times may vary, due to complexity of question and the volume of inquiries we receive.”
According to data in the TAN Inquiries Report, only about 10 percent (734) of the 7,280 submitted questions through November 2017 related to the PSR. Additionally, as of January 2018, the common questions/popular topics page does not yet include a PSR section. We would, however, expect PSR-related questions in the TAN to increase as growers continue to work toward full compliance of this rule.
There is, in fact, a post on a Michigan State University Extension (MSUE) webpage which discusses a TAN response to a question regarding the PSR exemption for growers who sell more than half their gross sales to a qualified end user. While the rule defines a qualified end user as the consumer of a local food, restaurant, or retail establishment, the discussion states that it was unclear whether a food hub would be considered a qualified end user and if so, under what conditions.
“We now definitely know some food hubs do not count as qualified end users under the FSMA Produce Safety Rule,” the MSUE post says, stating that the TAN response “indicated that food hubs with a farm-to-business model are unlikely to meet the definition of qualified end user, while those with a farm-to-consumer business model may meet the definition.” Excerpting from the TAN response, it adds, “Sales to the food hub would only be sales to a ‘qualified end-user’ if the food hub fits the definition of a retail food establishment or a restaurant, and meets the location requirements.”
The FDA also is continuing to provide PSR assistance through guidance documents, with the most recent being those focused on Small Entity Compliance; Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Preventive Controls Requirement; and FDA Enforcement Discretion for some aspects of certain rules, including the PSR. In late January, the agency also updated its PSR webpage with current information on the rule’s requirements, compliance dates, training, technical assistance, and other resources.
For more information, see the FDA’s communication on: