The fresh produce industry is watching closely as enforceable requirements in the FDA’s Produce Safety Rule gradually come into play at ground level. The rule is one of seven the agency has drafted to implement facets of the sweeping 2011 Food Safety Modernization Act (FSMA).

Published in the Federal Register on Nov. 27, 2015, the final version of the Produce Safety Rule “establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption,” according to the Food and Drug Administration. It covers both domestic and imported produce.

Produce harvestMost produce growers, packers, processors or sellers will be subject to the rule, with staggered compliance deadlines ranging from two to four years, depending on the size of the operation.

However, there are exemptions — and qualified exemptions — from the rule, such as farms having an average of less than $25,000 in annual produce sales during the previous three years.

Also eligible for exemption from the rule is any produce which:

  • is grown for personal or on-farm consumption;
  • is not a “raw agricultural commodity;”
  • will receive a “kill step” to adequately reduce microorganisms of public health concern; or
  • is a “rarely consumed raw” commodity, currently defined as asparagus, black beans, great northern beans, kidney beans, lima beans, navy beans, pinto beans, garden beets roots and tops, sugar beets, cashews, sour cherries, chickpeas, cocoa beans, coffee beans, collards, sweet corn, cranberries, dates, dill seeds and weed, eggplants, figs, horseradish, hazelnuts, lentils, okra, peanuts, pecans, peppermint, potatoes, pumpkins, winter squash, sweet potatoes and water chestnuts.

For U.S. produce operations covered by the Produce Safety Rule, it sets out several key requirements for the general areas of:

  • Agricultural water quality and testing;
  • Biological soil amendments, specifically raw manure and stabilized compost;
  • Sprouts, which the rule notes are “especially vulnerable to dangerous microbes;”
  • Domesticated and wild animals;
  • Worker training, health and hygiene; and
  • Equipment, tools and buildings.

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FDA estimates that the yearly benefits over the first 10 years after publication of the rule to be approximately 365,351 illnesses averted per year, valued at $977 million annually.

According to produce industry experts, plenty of questions remain about exactly how and when produce businesses must comply with the new produce rule.

“The biggest issue is compliance and guidance to industry from FDA,” said Jim Gorny, vice president of food safety and technology for the Produce Marketing Association (PMA) in Newark, DE. “From guidance to the compliance level, we really need the boots on the ground. Is this in compliance or is this out of compliance for an industry-specific level?”

Gorny is familiar with FDA operations from his stint with the agency as its senior advisor for produce safety from 2009-2013. Before working at FDA, he was executive director of the Postharvest Center at the University of California-Davis for two years.

PMA, which represents 2,400 members from all points along the produce supply chain in about 45 countries, has presented 15 training sessions around the country to date to help growers, Gorny said.

He said there are “a million questions out there” about various aspects of the rule and how it should be implemented at the farm level, particularly relating to water testing, paperwork requirements and other aspects.

“The problem with the Produce Safety Rule is you start getting into how many (water) samples you have to take and how do you get the samples. It’s like peeling back an onion, and it can only be addressed with specific questions,” Gorny said.

Training curricula are still being developed, he noted, adding that there probably won’t be anything specific available until September. And even when there is, he said there’s no one single applicable approach when it comes to explaining how complying with the rule will actually work.

Gorny called implementing the Produce Safety Rule “a heavy lift” for FDA because of the international outreach required to about 140 other countries that export food products to the U.S. That means translating all seven FSMA rules and supporting materials into numerous foreign languages and phasing in all the steps of implementation.

“It’s a four-stage process,” Gorny said. “There’s awareness of the rule, understanding what the rule actually says, implementing the rule in a facility or farm, and certification (making sure people are actually following the rules appropriately). It’s a multi-stage process. Right now, we’re at the awareness stage.”

Despite the two-year window the larger producers have for compliance, Gorny noted that the time for them to start adopting the rule’s water quality provisions is now.

“The rule is quite specific. You take samples while the crop is in the ground and as close to harvest as possible. Think about it with cherries or apples, which are only harvested once a year, and you’re only going to have a small window to take samples,” he said.

The costs and logistics involved with the rule’s water testing requirements also present major issues for some produce growers.

Water quality resources for produce growers, packers, processors and sellers are available from Research and Extension faculty at the University of California-Davis and also from the University of Arizona, as well as from other states and from produce industry consultants.

A notable aspect of the Produce Safety Rule is highlighted for PMA members on the organization’s website:

“This on-farm produce safety regulation is significant in that FDA will now put in place an enforceable implementing regulation which explicitly articulates on-farm standards of conduct for the safe growing, harvesting, packing and holding of fresh produce.”

Because of budget and staff limitations, FDA will need to contract out some of its inspection role under the Produce Safety Rule. Gorny said the agency is currently working on developing cooperative agreements with state departments of agriculture and health to get that done.

“They do want to prioritize inspection activities based on risk. They want to use market access audits that are already being used out there by USDA’s Agricultural Marketing Service to verify that people are following good agricultural practices,” Gorny said. “If people use good auditors, and the audit was robust, it can drive people to good resources where they’re most needed instead of a one-size-fits-all approach.”

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