Will FDA's on-farm inspections under FSMA's Produce Safety Rule make fruits and vegetables safer?
- The Food and Drug Administration announced routine inspections will start this spring of the largest domestic and international produce farms as required under the Food Safety Modernization Act's Produce Safety Rule, Food Navigator reported.
- According to a Feb. 7 statement from FDA Commissioner Scott Gottlieb, states will be doing most routine inspections to determine whether farms are complying with "science-based standards for the safe growing, harvesting, packing and holding, of fruits and vegetables."
- Gottlieb noted FDA has coordinated with a diverse group of stakeholders to help gear up for these inspections, and he said the agency will continue making resources available. So far, he said FDA has granted more than $85 million to 46 states and one territory to develop their inspection infrastructure. The agency has supported inspector training, issued draft guidance, shared expertise, and participated in creating a voluntary On-Farm Readiness Review program and farm inspection forms.
Now that the first on-farm inspections under the Produce Safety Rule will soon begin, the question is whether everyone involved will be ready. Getting to this point has taken a lot of effort since FSMA — the first major food safety reform legislation in more than 70 years — became law in 2011.
"At that time, U.S. produce farmers, and those in countries that export to the United States, had never been subject to this level of federal food safety oversight and, quite frankly, we at FDA had a lot to learn about the unique challenges farmers face every day," Gottlieb said in the Feb. 7 statement. "The idea of implementing preventive measures to head off food safety problems was a new and modern approach to regulation that promised to bring significant benefits for consumers."
Timelines have shifted throughout the different sections of FSMA. Routine inspections of large domestic and international produce farms were supposed to start a year ago, but operators told the FDA they needed more time to make sure enough training and information was available to help them comply. The agency agreed and postponed the first inspections until this spring. Smaller produce operations — those earning more than $250,000 but less than $500,000 annually — have until spring of 2020 to meet the requirements.
Agricultural water and testing-related inspections, which are part of the rule's requirements, have also been postponed because of objections from farm operations. The FDA extended those compliance deadlines four years for very small businesses, three years for small ones and two years for all others. This was a controversial move because of increasing foodborne illness outbreaks linked to fresh produce — with some traced back to irrigation sources.
Large domestic and international farms facing inspections this spring need to meet the rules' requirements regarding biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools and buildings. Sprouts growers have another set of rules in addition to those since the FDA considers the production of raw sprouts presents unique safety risks.
The long ramp-up period to Produce Safety Rule enforcement may have been worthwhile since the FDA and its state and local partners have put together an extensive array of resources to help those involved. The agency's grants to the majority of states and one territory funded produce inspections, along with education, outreach, and technical assistance to produce farmers, which helped fill the gaps.
According to Food Navigator, 350 farmers have already signed up for the On-Farm Readiness Review program coordinated by the FDA, the National Association of State Departments of Agriculture, and state and cooperative extension food safety leaders. That tool walks produce growers through the steps they'll be facing when on-farm inspections begin in earnest later this spring. With such a complex rule — and given the food safety problems it's meant to help solve — there will likely be bumps along the road, as there usually are when government regulations are involved.
The Produce Safety Rule may also need to be updated since the law was signed eight years ago and conditions on the ground may have changed. Recent produce contamination episodes — with three outbreaks of foodborne illness linked to romaine lettuce and other leafy greens in the past year alone — prompted the industry to implement a labeling protocol. The FDA also said it was beefing up romaine sampling and testing to detect contamination along the supply chain. Both of those developments could help calm consumer fears about the safety of fresh produce.
On-farm inspections and other regulatory and operational changes may finally start to get a handle on U.S. and foreign produce contamination. They may also give consumers more confidence when it comes to buying and consuming fresh produce. Demand continues to increase, so there's a built-in constituency. According to New Hope Network, fresh foods made up nearly a third of supermarket purchases in 2017, and sales from the perimeter of the grocery store have outpaced growth in other food and beverage departments. No doubt boosting produce food safety practices will add to that, but until the water-testing component is included, the rule may not accomplish all the goals as envisioned under FMSA.
- Food Navigator FDA readies for Produce Safety Rule for US farms, offers compliance resources
- U.S. Food and Drug Administration Paving the Road to Produce Safety Rule Inspections