“Coming down like a ton of bricks.”
“Complicated and interwoven.”
“The end of many small- and mid-size farms and food processors.”
“Never heard of it.”
“A work in progress.”
When asked about FDA’s new proposed rule for food processing facilities, that’s how a sustainable-agriculture advocate, a food-safety expert for a large fresh produce association, the Office of Management and Budget, a small-scale farmer who owns a processing facility, a farm commodity official and an FDA food safety expert — in that order — described it.
Referred to as HARPC (pronounced “harp sea”), the acronym stands for Hazard Analysis Risk-based Prevention Controls. Mandated by the Food Safety Modernization Act, signed into law in 2011, HARPC embraces a strategy that focuses on preventing foodborne illness and other risks make food unsafe to eat. As such, it would apply to certain unintentional hazards such as microbiological, chemical, physical and radiological hazards, as well as to allergens.
According to estimates from the U.S. Food and Drug Administration, 951,000 million cases of foodborne illnesses can be attributed each year to the pathogens that this rule is designed to eliminate or reduce. The economic cost of illnesses avoided comes to $2 billion a year.
A big player in the food safety arena, FDA regulates about 80 percent of U.S. food supply—$602 billion in domestic food and $64 billion in imported food each year. That accounts for nearly everything consumers in the United States eat except for meat, poultry and some egg products, which are regulated by the U.S. Department of Agriculture.
While HARPC is intertwined with the FDA’s proposed produce rule, which focuses primarily on preventive controls on the farm, HARPC puts the spotlight on what’s happening in food processing facilities.
For the most part, HARPC would apply to facilities that manufacture, process, pack or hold human food. These would include manufacturers, processors, warehouses, storage tanks and grain elevators, although there are some exceptions. Bottom line – HARPC would apply to facilities that are required to register with FDA under the agency’s current food facility registration regulations, which went into effect under the 2002 Bioterrorism Act.
When looking at the numbers, the proposed rule would cover an estimated 97,600 domestic and 109,200 foreign facilities. (According to FDA, in 2011 about 50 percent of the fresh fruit consumed in the U.S. was imported.)
What triggers HARPC on a farm?
Not surprisingly, there’s a lot of confusion, and even alarm, about the activities conducted by a farm that might cause it to fall under the FDA’s definition of a processing facility.
According to detailed-but-straightforward information about who would be affected by HARPC supplied by the National Sustainable Agriculture Coalition, the key distinction between a farm and a facility “seems to be whether you are transforming a product in any way.”
Farms, as defined by FDA, won’t be subject to HARPC, said FDA’s Jenny Scott. According to FDA’s definition, a farm is an agricultural operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood) or both. It can also include facilities that pack or hold food, as long as all of that food is grown or raised on that farm or on another farm under the same ownership.
Farms that grow and harvest their own food crops are exempt from the facility registration rule. But if the farm purchases product from another farm to sell at its own retail operation and/or through wholesale transactions, it is then considered a facility and therefore required to register with FDA as a processing facility.
If a farm doesn’t grow a crop but sells it, HARPC also kicks in. Likewise, if a farm is growing fruits and vegetables and then doing anything beyond standard practices to prepare that fruit or vegetable to sell it as a whole product, HARPC would kick in. Drying, baking, cutting, and mixing products all trigger HARPC.
Manufacturing and processing always includes these activities:
– Cutting, coring, chopping, slicing
– Coating with things other than wax, oil, or resin
– Drying that creates a distinct commodity
– Artificial ripening
– Pasteurizing, homogenizing
– Grinding, milling
– Slaughtering animals or post-slaughter operations
Going beyond what’s already expected
Although HARPC is similar to HACCP, Hazard Analysis and Critical Control Points, a food-safety system already in place for juice, seafood, and some produce processing plants when commercial buyers require it, it goes a bit further than HACCP.
The main difference between the two systems, said Jenny Scott, senior advisor in FDA’s Office of Food Safety, is that under HARPC, preventive controls may be required at points other than at critical control points, and critical limits (such as temperature and time requirements) would not be required for all preventive controls.
In a recent Food Safety News article about this risk-based preventive approach to food safety, Scott said that facilities that already have HACCP plans in place may need to make some changes, but for the most part, they “will be well on their way toward complying with preventive control rules.”
Pull out a pen and paper
During a presentation about HARPC, David Gombas, food safety expert at United Fresh Produce Association, called up images of a pen and paper — in other words, a lot of paperwork — when he described the proposed provisions of HARPC:
-Written food safety plan
– Written preventive controls for identified hazards
– Written monitoring procedures and frequencies
– Written corrective actions
– Written verification procedures, including validation of most preventive controls
– Written recall plan
The specter of additional paperwork and the time and expense involved in gathering the necessary information for the paperwork always rises up to haunt small- and mid-sized businesses. And with that specter come fears that HARPC will push food processors of this size off the map.
“These businesses don’t have much, if any, room to raise food costs to cover the added expenses,” said Kristen Wilmer, program assistant at Community Involved in Sustaining Agriculture.
According to the White House Office of Management and Budget, the proposed rule has a first-year cost to the industry of $701 million and an annualized cost of $472 million, using a 7 percent discount rate.
Trevor Suslow, food safety expert at University of California, Davis, told Food Safety News that it’s the mid-level and smaller-scale food processors consolidating product from multiple farms that will face the greatest challenges.
“Bottom line, it will take some work,” Suslow said, pointing out that most of the large food processors “are already about there,” in meeting HARPC’s requirements.
But Suslow also said that the FDA recognizes that different scales of operations need to be considered. He also warned about becoming polarized over specific sections of HARPC.
“At a reasonable, commonsense level, these smaller food processors can implement what’s expected of them,” he said. “There are ways for people to put something in place. I certainly hope this won’t push people out of business.”
Along those same lines, the FDA describes the preventive controls as science- and risk-based and points out that the proposed rule would require controls only where necessary to prevent hazards to public health and would exempt certain facilities from requirements or modify requirements for certain low-risk activities.
In addition, the requirements are flexible in that food processors could develop preventive controls that fit their products and operations, as long as they are adequate to significantly minimize all food-safety hazards that are reasonably likely to occur, according to FDA.
Size does come into play when it comes to exemptions. With certain stipulations and requirements, “small” and “very small” processors, as well as those with a previous 3-year average product value of less than $500,000, would qualify for an exemption, but they would not be exempt from following food-safety rules and good handling practices.
For more information about HARPC and exemptions from HARPC, visit FDA’s FAQ page. FDA also offers a chart showing exemptions and modified requirements for Preventive Controls for Human Food.
What about CSAs and farm stands?
FDA’s Jenny Scott said that farm stands and CSAs (Community Supported Agriculture) organizations, which are similar to subscribing for baskets or boxes of food on a regular basis from a farm or group of farms) would likely be classified as “exempt retail establishments.” That would mean they wouldn’t be subject to HARPC, although food-safety practices would need to be followed. But since this is a proposed rule, there’s no saying how the final rule, which is expected to be released late next year, will actually treat these sort of farming operations.
What about current Good Manufacturing Practices?
According to an article in Food Processing, for the past several decades, current Good Manufacturing Practices (CGMP) have provided the primary food safety framework for most foods regulated by the FDA. As such, they cover practices that need to be followed to ensure that food is manufactured, processed, packed and held under sanitary conditions and that the food is safe, clean and wholesome.
While HARPC embraces the same goals, it goes in a different direction, pointing the way to preventing food from being contaminated with harmful pathogens such as E. coli, Salmonella and Listeria, which can sicken or kill people. The goal is to make sure that specific potential threats to the food supply can be identified so that effective measures can be taken to counter them before any harm can occur.
Make sure to send in written comments
FDA’s Jenny Scott said that it’s extremely important for people to send in written comments, primarily because the agency needs to know what people are concerned about and what they would like to see changed and why.
“We really want to hear about specific situations and concerns and how people would be impacted by the proposed rule,” she said. But she emphasized that it’s only when the agency gets a written comment that it can be considered.
Comments can be submitted on the Federal Register. To read already-submitted comments about HARPC, enter docket #FDA-2011-N-0920 on the Federal Register’s site.
Due to requests from many people in the ag industry, the comment period was extended to Sept. 16, 20013.
The first year of enforcement will likely be 2016, although the dates are staggered for small facilities (3 years) and for “very small” facilities (4 years).
I need help with this
Scott said that people can ask their county extension agents for help figuring out whether their farm or processing facility needs to comply with HARPC requirements. During office hours (Eastern Standard Time), they can also call this toll-free number: 1-888-SafeFood (723-3366).
In the meantime, the Food Safety Preventive Controls Alliance is developing FDA-approved training materials for implementing HARPC. Guidance on the best way to implement the requirements is also being developed.