FDA has announced it will exercise enforcement discretion for Produce Safety Rule requirements that apply to entities that grow, harvest, pack and hold wine grapes, hops, pulse crops and almonds. The agency added that it will “consider pursuing rulemaking to address the unique circumstances” that the above-mentioned products present. It also issued the guidance document, “Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds”.
FDA Commissioner Scott Gottlieb, M.D., announced the next steps in their approach to implement the Produce Safety Rule that was established by FSMA. During the September 12th speech at the National Association of State Departments of Agriculture, Dr. Gottlieb outlined new measures the FDA will be taking, including compliance dates for agricultural water standards, recognized water-testing methods, and inspections related to non-water requirements of the produce rule.
According to the press release, Dr. Gottlieb also announced steps the FDA will take to “address concerns related to the complexity and feasibility of implementing standards for agricultural water.” One proposed rule concerning agricultural water compliance dates, if finalized, would extend compliance dates by up to four years for produce other than sprouts.
The press release states the reasoning behind this change is allowing the FDA to revisit those standards, ensuring they are implementable for farmers across the country. Sprouts are an exception here because of their high risk for contamination and will remain subject to original compliance dates.
The announcement also covered key changes to produce farm inspections, water testing methods and training opportunities for producers and regulators. For more information, see the press release here and the full text of Dr. Gottlieb’s speech here.
Learn more about FSMA implementation strategy at the 2017 Food Safety Consortium | November 28–December 1FDA has released a Small Entity Compliance Guide (SECG) to help small and very small businesses comply with the Produce Safety Rule. The SECG provides assistance for farmers in determining whether they are eligible for a qualified exemption and can help them understand the modified requirements as a result.
The compliance dates under the Produce Safety rule are as follows:
- Small businesses: January 28, 2019
- Very small businesses: January 27, 2020
- Sprout operations: January 26, 2018 (small businesses) and January 28, 2019 (very small businesses)
- There are also extended compliance dates for certain agricultural water requirements
With several FSMA compliance dates now in effect, much of the focus is on where companies need help. According to Kathy Gombas, former deputy director at CFSAN, the industry is struggling with FSMA training. Many companies don’t understand the FSMA rule exemptions and supply chain requirements, and they just don’t know where to start. “Industry needs affordable and timely resources,” said Gombas during a panel discussion at the Food Safety Summit earlier this month. “There are a lot of tools out there, but they’re costly.”
Efforts are underway to address these challenges. FDA has issued more than a dozen guidance documents pertaining to the rule. In addition, tools such as model plans and templates can help companies with their food safety plans, and the agency is almost ready to publish a web-based food safety plan builder that will be freely accessible on FDA’s website, according to Gombas. Several sources of technical assistance are available, including state and trade associations, academia, and the technical assistance network (TAN). However, when companies have inquiries, the key is to provide them with a response in a timely manner, said Gombas.
The Produce Safety rule is another hot spot for hurdles. Although 90% of it aligns with Good Agricultural Practices that have been in place for more than a decade, industry’s response to the rule remains one of fear and confusion, said David Gombas, former vice president of technical services for the United Fresh Produce Association. “Water testing is probably the most complicated aspect of the regulation,” he said. The rule calls for testing procedures that many produce companies never had to conduct before. Some testing must be done within a certain period of time, and the lower number of testing labs in rural areas of the United States will pose a problem for some producers, warned David Gombas.
There is also confusion among producers regarding whether they should follow the Produce Safety Rule or the Preventive Controls rule, which could significantly impact the steps they must take to be in compliance of either rule. To further complicate matters, Gombas pointed out that many foreign suppliers aren’t even aware that they have to be in compliance with the rule. Finally, the Produce Rule does provide a lot of room for flexibility, so Gombas predicts much of the responsibility will fall on the agency inspectors and how they expect rule to be met.
FDA has awarded $21.8 million to 42 states to support the implementation of the FSMA Produce Safety rule. The State Produce Implementation Cooperative Agreement Program (CAP) provides states with the resources to enable the following:
- Form a multi-year plan to implement a produce safety system
- Education, outreach and technical assistance
- Prioritize farming operations covered by the rule
- Develop programs to address the needs of farming communities
According to FDA, “the intended outcomes of this cooperative agreement program are to:
Advance efforts for a nationally integrated food safety system (IFSS)
Plan, establish, and/or enhance state and territorial produce safety programs.
Encourage the safe production of fresh fruits and vegetables.
Promote understanding and compliance with the requirements of the Produce Safety Rule.”
Applicants were classified into five tiers of funding eligibility based on the number of farms growing covered produce within the jurisdiction. The agency has also provided a list of funding award amounts by state.
|Learn more about FSMA at the 2016 Food Safety Consortium | December 7–8, 2016 | Schaumburg, IL | VIEW AGENDA|