Most regulations tied to passage of the Food Safety Modernization Act won’t take effect until January 2018, but that doesn’t mean growers and packers can stop moving toward implementation — even if trying to do so feels like deciphering a Common Core math problem.
That’s how one employee of the Food and Drug Administration described trying to understand the myriad ways the rules can be interpreted and applied to different sectors of the industry.
It’s one of the main reasons some rules have been delayed. However, there are still things growers need to be aware of in the days and months ahead.
While initial compliance dates for the Produce Safety and Preventive Controls for Human Food rules have both been delayed to January 2018 — the Produce Safety rule was always 2018, but its water sampling requirement to begin testing sooner has also been delayed to 2018 — the Sanitary Transportation Rule went into effect April 1.
The sanitary rule has minimal effect on the tree fruit industry; most of the duties under it are assigned to the shipper, which is the entity that is arranging transportation of the produce.
In most cases where packers are selling fruit to retailers, it is the retailers or buyers who arrange transport and are responsible for compliance.
However, in some cases, packing houses covered under the Preventive Controls Rule may need to comply. (Any fruit transported from orchard to packing house is exempt, and any facility covered under the Produce Safety Rule is exempt.)
“It really applies to some common sense things that packing houses are already doing,” Woods said. “If you have a forklift loading a truck, make sure it meets food safety requirements. If your workers see chicken feathers on the truck or smell something funny, they need to make a decision not to load.”
There will be some new paperwork requirements to show inspectors that these activities are taking place.
In addition, packers will need to consider how their bins are cleaned or stored (the preference being either indoors or on pavement or gravel to reduce the risk of accumulating organic matter or pests).
However, in a change from the draft rule, shippers no longer have to worry about regulating temperature to meet a food safety requirement, as it’s been deemed an issue of food quality, rather than food safety.
Some questions remain.
“There are still some other questions with how this affects packing houses in cases where they’re shipping a carton of fruit from one packing house to a sister packing house (under the same ownership) or in the same marketing group. There also some questions about how it affects fruit sent to processors,” she said. “But all in all, in terms of practices, these are all things packing houses are already doing.”
One area where growers will likely see some changes to the regulations is in agricultural water testing.
The industry overall was unhappy with the final rule, given the complexities of the water testing rules and the lack of scientific research to back up the requirements, Woods said.
Last August, the FDA delayed the water testing compliance dates so that growers would need to begin conducting water sampling in 2018 (instead of completing 20 tests on each water source over two to four years prior to 2018).
But amid continued concerns from the produce industry that the rule was too challenging and burdensome to implement at the farm level, the agency announced earlier this year that it would reconsider water sampling requirements.
Among the unresolved questions: What defines a water source? Can a grower cooperate with a neighbor to sample water, and if so, how? How can an irrigation district sample for growers?
“We don’t know for sure if growers will still be testing for E. coli. We fully anticipate that there will be a water testing requirement, but we do not know what it is going to look like,” Woods said.
In the meantime, the Northwest Horticultural Council has been cautioning growers to hold off on making substantial investments in water sampling programs until they know more about the final water requirements.
However, Woods said growers still should continue to pursue training programs that focus on good sampling practices, if not the specifics of the methodology.
Barb Fick is a Northwest regional extension associate for the Produce Safety Alliance, a collaboration of Cornell University, FDA and the U.S. Department of Agriculture to prepare fresh produce growers for FSMA’s regulatory requirements. She said the group continues to train growers as the law currently stands, recognizing that further guidance may be coming — they just don’t know exactly when.
Meanwhile, training sessions — including “train the trainer” sessions intended to get more lead trainers recognized in the industry — are ramping up across the country, Fick said.
The industry may be awaiting one last ruling from the FDA, and while it seems simple, it’s anything but: the definition of “farm.”
Currently, while all orchards are considered farms, the Preventive Controls rule determines whether a packing house or storage facility falls within this definition based on on the ownership structure of the business.
If more than half the fruit at a packing house or storage facility comes from orchards under the same ownership, the facility falls under the Produce Safety rule. Less than half, and it falls under the Preventive Controls rule.
“With the complex ownership structures in agriculture — not just in our industry — everybody was confused, and the stakes are really high,” Woods said. “We had concerns from day one, having two facilities that do exactly the same thing being regulated differently.”
In cooperation with others in the industry, the Northwest Horticultural Council provided FDA real-life examples of 17 different farm ownership structures from across the U.S. and Canada. In response, one FDA employee compared it to his child’s Common Core math homework, Woods said.
“They recognize this isn’t workable. It’s not workable for farms, and it’s not workable for inspectors who need to handle this, and it needs to be fixed. That was good news,” she said.
The industry has advocated that the definition should be “activities” based, meaning if an apple comes in and goes out and the product doesn’t change, it should be a farm. A processor, such as a company that slices apples, would not.
So where does that leave everyone going forward?
Growers should examine their food safety plans to see areas they may need to improve or where they have questions that still need to be answered, Woods said.
And don’t make the written plan too restrictive as you’re just getting started, because auditors will judge you based on your written plan.
FDA has been clear that inspectors will prioritize education over compliance in the early days.
In terms of packers, it’s a tougher situation. Choose the rule you believe you fall under and move forward to meet it, Woods said.
“We think 90 percent of our growers are almost there in terms of compliance,” she said. “But even with the delays, the January 1st compliance dates are fast approaching.” •
– by Shannon Dininny