Research by scientists in Washington and other parts of the country could influence what will be required from tree fruit growers and packers as the Food and Drug Administration implements new food safety regulations.

Since the Food Safety Modernization Act became law in 2011, the FDA has been developing a series of rules covering food production, handling, transportation, importation and auditing, with the focus on preventing food-related illnesses.

Kate Woods Staff of the Northwest Horticultural Council on March 9, 2015 in Yakima, Washington. (TJ Mullinax/Good Fruit Grower)

Kate Woods

Kate Woods, vice president of the Northwest Horticultural Council, said the FDA, which had never before regulated farms, began proposing very prescriptive rules governing on-farm practices.

However, there was not much data showing the safety or health risks to consumers posed by current growing practices for different types of produce.

For example, little was known about which pathogens farmers should test for in water and at what levels the water could be considered safe for application to tree fruit if pathogens are present.

Nor was it known where the water should be sampled within the irrigation system to get the most accurate reading, or what the best mitigation measures might be.

Growers are covered by the Produce Safety Rule (standards for the growing, harvesting, packing and holding of produce).

Most Northwest tree fruit growers irrigate from open canal systems, and the initial version of the rule (proposed in January 2013) included water standards that seemed completely unachievable in terms of how frequently growers would be required to test their water supply and what they should do if results came in at unacceptable levels, Woods said.

After receiving feedback and releasing an interim draft of the rule for public comment, the FDA published the final rule on Nov. 27.

It includes slightly more workable standards and requirements for produce growers and some flexibility should future scientific studies show different methods that would allow producers to meet FDA’s standards for human health protection.


Woods said research is being done around the country, some of it funded by the Center for Produce Safety, to fill in the gaps and provide information that will be critical as the regulations are implemented.

For example, Dr. Karen Killinger, former food safety specialist at Washington State University, and Dr. Ines Hanrahan, project manager with the Washington Tree Fruit Research Commission, have been working on projects relating to food safety in the orchard and packing house. (Read “Food safety research focuses on packing.”)

The final Produce Safety Rule is 801 pages long, and Woods said that, as of press time for this issue of Good Fruit Grower, the Northwest Horticultural Council and other produce organizations were still analyzing and seeking clarifications from FDA on exactly how it will impact growers.

However, as was expected based on previous versions, the rule will require growers to test their water and take certain actions should microbial tests come back above a set threshold close to harvest.

The rule appears to provide options for science-based alternatives to certain parts of the new water requirements created in the rule.

It’s hoped that, based on data from current or future research, the FDA will be able to give growers flexibility in setting and achieving these standards and not force them to meet requirements unnecessary for human health protection.

The research also will provide growers with information to help them implement the rules.

Very small growers — those with less than $250,000 in annual produce sales — will have four years from Jan. 26, 2016, the day the rule goes into effect, to comply with most provisions in the Produce Safety Rule.

Growers with $250,000 to $500,000 in sales will have three years to comply, and all others will have two years. However, growers will be given an additional two years to meet the water quality standards because of concerns about the difficulty that growers may have in meeting these new requirements.

Woods said once the industry has finished analyzing the rule and has a better idea of exactly what will be required, growers should start looking at their operations to see if changes need to be made. The FDA is preparing guidance documents, but it’s not known when they will be issued.


The other FSMA rule that will have a significant impact on the tree fruit industry is the Preventive Controls for Human Food Rule.

Some fresh fruit packers might fall under the Produce Safety Rule if most of the fruit they pack comes from company-owned orchards, though the location of the orchards is also a factor.

However, if most of the fruit comes from outside growers, the packer will likely fall under the Preventive Controls for Human Food Rule instead. This could lead to some confusion at first, Woods said.

Packers who handle fruit from their own orchards and from other growers will need to determine which rule applies to them. This also applies to storage facilities.

The FDA issued the final version of the Preventive Controls Rule in September 2015. It’s a document of more than 900 pages that industry representatives are still analyzing in order to understand the implications.

One thing’s certain: It will require more paperwork from packers to document their use of safe practices. Each packer will need to identify food-safety hazards in their facility and how to address them.

An industrywide approach won’t work, Woods said, because each packing facility has different points where there might be vulnerabilities and different solutions that might be best to address them.

“There’s information we can provide, but I don’t think there’s going to be a cut-and-dried plan that’s going to work industrywide,” she said. “There’s certainly going to have to be science and data and research provided to assist packing houses to address these concerns.”

Woods said Pacific Northwest fruit packers won’t have to duplicate what they’re already doing for third-party auditors or the U.S. Department of Agriculture’s Good Handling Practices, but there will likely be additional requirements that will take additional time and resources at first.

Produce industry organizations, such as the Northwest Horticultural Council, Produce Marketing Association and United Fresh Produce Association are all still analyzing the Preventive Controls Rule to find out exactly what it will mean for packers.

Very small businesses, with less than $1 million in annual sales, will need to comply with the Preventive Controls Rule by September 2018.

Small businesses,  those with fewer than 500 full-time equivalent staff, will have to comply by September 2017. All others will need to comply by September 2016.

The FDA will publish guidance documents specific to fresh produce packing that should provide more information on how the FDA will interpret the rules, but Woods said it’s not known when those will be available.


Woods said there should be plenty of training opportunities for growers and packers. The Produce Safety Alliance at Cornell University in New York will offer train-the-trainer courses for people interested in training growers on how to meet the Produce Safety Rule requirements. FDA has been working with the alliance to develop the curriculum.

Industry associations, including United, PMA and the Washington State Tree Fruit Association are working on education and training efforts for producers. Since the FDA has no experience with regulating on-farm practices, the agency will probably also work with states to implement and enforce the rules, though that’s not yet been announced. •

– by Geraldine Warner