Questions arise about proposed food-safety rule

Issue Date: September 4, 2013
By Christine Souza
David Long and his son Dexter Long of Hilltop Ranch Inc. in Ballico show off the company’s new vacuum-steamed pasteurizer, which can pasteurize 8,000 pounds of almonds in about a minute as a food-safety process.
Photo/Christine Souza
Quality control technicians Emma Reyes, left, and Yadira Gonzalez test each load of almonds for salmonella and aflatoxin.
Photo/Christine Souza

Editor's note: This is Part 5 of a series of stories about how proposed federal food-safety rules could affect California farmers and ranchers.

When does a farmer become a food processor?

That question—and uncertainty about how to answer it—confronts both farmers and processors as they consider the proposed "preventive controls" rule under the Food Safety Modernization Act.

The U.S. Food and Drug Administration proposed the rule earlier this year, along with a separate rule for raw produce, and will accept comments on the rules until mid-November.

The proposed rule on preventive controls for human food applies to those who "grow, harvest, pack, or store a commodity." In general, the rule also would apply to facilities currently required to register with FDA, such as manufacturers, processors, warehouses, storage tanks and grain elevators.

"In talking with farmers, processors and food-safety specialists, it's obvious that there's confusion about how the produce and preventive-control rules may overlap," said Josh Rolph of the California Farm Bureau Federation Federal Policy Division. "The preventive-control rule also contains a number of exemptions and limitations. The rule is not at all cut-and-dried, and that makes it extremely frustrating for growers, processors and many commodity organizations as well."

For example, according to Sonia Salas, director of science and technology for Western Growers, the FDA considers coring lettuce in the field to be processing and, as a result, the operation falls under the preventive-controls rule.

"Coring lettuce has been typically considered part of harvest activities, so that would not make sense for some operations that only deal with that type of activity," Salas said. "We are drafting comments and asking that the FDA be clearer with the definitions and consider certain activities that are still within the harvest definition."

Jenny Scott, senior advisor in the FDA Office of Food Safety, acknowledged there is confusion over where the proposed regulations for produce and preventive controls might overlap. To try to provide guidance, she cited a few specific examples:

  • Slicing and dicing of any agricultural commodity is considered manufacturing and processing, and automatically puts that operation into the "farm-mixed-type facility" category. Unless an exemption applies, the facility would be subject to FDA requirements for Hazard Analysis and Preventive Controls. There are exemptions for very small facilities—FDA has proposed three options for how that term would be defined—and for certain other facilities.
  • A nut-handling facility such as an off-farm dehydrator, huller or sheller is considered a processor and would be covered by the preventive-controls rule. The facilities would be required to have a food safety plan for how they handle those nuts, unless an exemption applies.
  • The FDA considers the drying of grapes to be processing, because it creates a new commodity. But if the only potentially covered activity that a grape grower does is drying grapes to make raisins, and the farmer meets the definition of a small or very small business, the farmer would be exempted.
  • The growing and harvesting of tomatoes is generally subject to the produce safety standards, but there is an exemption for produce that receives commercial processing that adequately reduces the presence of microbial pathogens, such as tomatoes for canning. A tomato processor falls under the preventive-controls rule. The only exemption for canning is for low-acid canned foods, such as green beans.

Once a processing facility determines it is covered under the proposed rule, the rule requires hazard analysis and risk-based preventive controls similar to Hazard Analysis and Critical Control Points systems developed by the food industry. Some facilities would be required to implement a written food safety plan through the evaluation of food safety hazards and to implement controls to minimize or prevent hazards. Monitoring and recordkeeping are also required.

FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly. Depending on the size of the facility and the activities of that facility, Salas said, some would be required to comply with only modified requirements.

Tom Vogel, director of food safety for the Dried Fruit Association of California, said because the information provided by FDA is not commodity-specific, it is difficult to navigate.

"I don't think the information out there is clear and it is not targeted to specific commodities," Vogel said. "We've developed a specific brochure for dehydrators, hullers and shellers, because those are the folks who are being enveloped in this program who haven't been in the past. Five years ago, an almond huller wasn't considered to be a food processor and now it is."

In response to outbreaks of salmonella in 2001 and 2004 traced to raw almonds, the Almond Board of California and U.S. Department of Agriculture created a mandatory program requiring all raw almonds to be sterilized through pasteurization. Based on the existing program and the proposed FSMA rules, family-operated Hilltop Ranch Inc. in Ballico recently upgraded to a new pasteurizer for its own almonds and those it processes for other growers.

"The almond industry as whole is way ahead of the FDA as far as the Food Safety Modernization Act. We've already implemented all of the necessary controls to guarantee that almonds are a safe, healthy food to eat," said David Long of Hilltop Ranch.

California League of Food Processors President and CEO Rob Neenan said California food processors are already subject to rigorous regulation and inspection and most already have HACCP plans in place, plus a wide range of practices and controls to ensure product quality.

"Our main concerns are that FDA seeks as much input as possible from stakeholders, provides a reasonable time frame for compliance and works with industry to refine the regulations to address problems that arise with implementation," Neenan said.

To determine whether a farm facility would be covered by the FSMA preventive-controls rule, go to

(Christine Souza is an assistant editor of Ag Alert. She may be contacted at

See related President's Message and read the full series online at

Permission for use is granted, however, credit must be made to the California Farm Bureau Federation when reprinting this item.

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