by Sally Colby
By now, growers should be aware of the proposed Food Safety Modernization Act (FSMA), which is, for the most part, nothing new. However, several areas of the proposed act are still open to interpretation, and growers whose operations will be affected have an opportunity to comment by November 15, 2013.
Who has to follow the new rule? It depends--and it's complicated. The rule includes two segments: produce safety and preventive controls (hazard analysis). Although the produce safety segment is fairly clear, the preventive control section is more open to interpretation.
"These rules are not new," said Lori Pivarnik, food science specialist at the University of Rhode Island. "The rules follow what has already been done before."
Pivarnik says that growers should first determine whether or not they are a processor, and whether the operation falls under the definition of a farm. For purposes of the proposed rule, a farm is a facility devoted to the growing and harvesting of crops, raising animals, or both.
"Mixed facilities" are farms that grow and harvest crops or raise animals and also conduct activities that require registration of the establishment. According to the U.S. Department of Health and Human Services/USDA, some mixed facilities are covered under the Proposed Rule for Preventive Controls for Human Food. A farm fits the description of a mixed facility if the farm manufactures, processes, packs or holds food that is not grown, raised or consumed on any farm you own, or if your farm manufactures or processes any food produced on your farm or on another farm that you own, and that food is not consumed on any farm you own.
One section of the rule needs to be clarified, because the term "processing" includes a range of activities such as cutting, trimming and peeling. "If any part of your system says that you're a processor, the first thing you have to do is register as a processor with the FDA," explained Pivarnik. "That doesn't mean that the full regulatory load of these rules will come down, but you need to register, then decide whether or not you're exempt. If any part of your operation is a farm and part is a processor, you need to register."
When do exemptions apply? Pivarnik says that operations that have no more than $500,000 in gross sales, sell more than 50 percent of products through direct marketing, and work within 275 miles are partially exempt from the rules. These operations must, at minimum, keep records and be able to show that proactive measures are being taken to ensure food safety.
"If you store raw agricultural commodities, you must comply with both good manufacturing practices and preventive controls," Pivarnik added. "If you're storing raw commodities for the purpose of distribution and processing, the FDA considers you a processor, and there lies the issue we aren't quite sure about; if you 'hold' for the next season, what does [the] FDA consider you?"
The rule amounts to a food safety plan referred to as HACCP (hazard analysis and critical control points). "This plan has two pieces, risk assessment and risk management," Pivarnik noted.
Good manufacturing practices (GMPs) have been updated, and many farms that would be exempt in one area of the rule still fall under the GMP section. For example, a small farm making jams or jellies from fruit grown on the farm may not fall under the full weight of the preventive controls section, but will have to comply with the GMP section.
Pivarnik said GMPs address topics such as building design, equipment maintenance, plumbing, floors and walls, and also serve as a basis for other controls. "There are pieces of the GMP that aren't specifically part of HACCP, but do have to be considered if you are a processor," she said. "Ask yourself, 'Am I a processor, do I have to register?' Once you answer that question, things fall into place.'"
For the risk assessment (hazard analysis) portion, producers must determine if there are any hazards to the process they're doing. Growers should consider what hazards--biological, chemical, physical or radiological--might be part of their process or product. "Is there a salmonella or listeria problem, or other chemical problems that will come into the product or process? If you cook and cool, there are issues to consider. If you're holding a ready-to-eat food product, refrigeration becomes an issue. It isn't about quality--it's all about safety."
In addition to the process, or HACCP-related controls, producers will need to implement preventive controls including sanitation, recall programs, allergen controls and supplier controls.
After examining every step in the process, the producer will have to determine where, if at all, steps must be taken to ensure food safety. Pivarnik said that developers are in the process of creating training materials for producers who need to consider an HACCP plan. The materials will be nationally uniform so all producers will have the same training.
For details about the proposed rule, producers can visit www.fda.gov/Food/GuidanceRegulation/FSMA
. This site also contains a link for public comments; the comment period ends November 15, 2013.
The author is a frequent contributor and freelance writer who farms and raises Great Pyrenees in south-central Pennsylvania. Comment or question? Visit www.farmingforumsite.com and join in the discussions.
Photos by Sally Colby.