It’s been almost three years since the original proposed Rules for Produce Safety and the Preventative Controls for Human Food, both portions of the 2011 Food Safety and Modernization Act, designed to prevent food-borne illnesses, were unveiled. Since that time, stakeholder input has led to re-evaluation and clarification of several provisions in both of these rules. Final FSMA regulations include some key changes from the original proposals.
The Preventive Controls for Human Food Final Rules were announced in September, while the FSMA Final Rule on Produce Safety was announced in mid-November. Both will be implemented in a tiered phase-in system, depending on the size and scope of a covered operation.
Farm Definition and Impacts
For produce growers, the definition of “farm” was a key element. Any entity that qualifies as a farm is not subjected to the Preventive Control rules. The Produce Safety Rules address on-farm contamination hazards including the planting, harvesting, packing, processing and holding of Raw Agricultural Commodities. RACs are all produce products except those which are “rarely consumed raw,” as per the FDA. It is important to note that sprouts are covered separately than other RACs due to high contamination risks.
The final rules recognize that farm operations have “a broad range of crops and practices,” and were written to identify common routes of on-farm contamination across a range of practices — says Dr. Samir Assar, Director, Office of Produce Safety, Center for Food Safety & Applied Nutrition. The final FSMA regulations include two types of farms; a primary production farm and a secondary activity farm. Produce rules are the same for either category of farm.
A primary production farm functions “under one management,” and operates at “one general location” that is not necessarily contiguous and includes on-farm packing and holding of RACs no matter who grew it. In addition, provisions allow a primary production farm to manufacture, process and hold foods if all such food is consumed on premises.
A secondary activity farm can harvest, pack or hold RACs, as long as a primary production farm owns or holds a majority interest in the secondary activity farm.
These farm definitions were adjusted to reflect modern business practices and are expansive enough to include common practices such as food aggregators, cooperatives and on-farm processors, Dr. Assar explained.
There are exemptions from the regulations. Very small farms, with less than $25,000 annual sales, are exempt. If a farm produces a commodity determined by the FDA to be excluded as a RAC, the rules do not apply to that product only.
Modification of the Produce Rules apply if RACs are grown for processing using methods which have been determined to adequately reduce pathogen counts to acceptable levels. Another modification exists for farms with under $500,000 in annual sales and who sell directly to the end-user, defined as a consumer or a retail/restaurant establishment within 275 miles or within the same state of the farm.
Water used in all areas of produce operations must be safe and sanitary. Agricultural water includes any water that comes in contact at any time with RACS or equipment used for the growing, harvesting or handling of RACs. Ground and surface water sources have different testing and monitoring requirements.
Treated water, no matter the source, has requirements covering the method of delivery, and monitoring treatment efficacy, as well as taking corrective measures and keeping records. Untreated surface and ground water have separate directives for establishing a Microbial Water Quality Profile (MWQP) over time, and for follow-up testing. Surface water, which is “more vulnerable to variation,” must be sampled more extensively.
The MWQP for ground water sources requires four samples be taken within one year, and annual samples thereafter. Surface water requires 20 samples be taken over a minimum of two years and a maximum of four years. Thereafter, five annual samples are required.
There are numerical criteria for safety limits depending on the water’s on-farm use. Online tools will be available for farmers to utilize to assist with calculating the Geometric Mean and the Statistical Threshold Value, both of which will be used to determine limits on generic Escherichia coli counts.
Biological Soil Amendments of Animal Origin
Original provisions called for long interval, “supported by science,” between the use of untreated manure and harvest, but this does not reflect common practices, Dr. Assar said.
The FDA will “revisit” some of the issues surrounding raw manure in five years. The National Organics Program standards call for a 120 or 90-day interval between raw manure application and harvest, depending on crop contact with soil. The FDA is advising that this standard be followed. Certain conditions must be met during application, growing and harvesting, to prevent contact between RACs and untreated soil amendments originating from animals.
Animal products that are treated by physical, chemical or biological processes have limits on acceptable microbial counts. Two separate methods of composting have proven to meet these limits, Dr. Assar said. While there is no requirement for testing specified, producers must insure that treated soil amendments of animal origin fall within the required limits.
Worker Training and Hygiene
Training for all personal who come in contact with RACs in any aspect of their jobs is required, at hiring and annually thereafter. Harvest personnel require additional training, including a supervisor trained to FDA curriculum standards.
Worker hygiene standards include hand-washing requirements, jewelry regulations and employee prohibitions on smoking, gum chewing or eating in work areas. Beverage drinking is allowed, however.
Workers cannot harvest produce that has fallen to the ground pre-harvest. This does not apply to crops such as almonds, which are shaken from the tree as a part of an acceptable harvest process.
Facilities and Equipment
Covered RACs must be kept separate from non-covered crops. Equipment and buildings must be cleaned between use for non-covered crops and RACs. Building can be fully or partially enclosed, but must be able to be cleaned – and sanitized when needed – to rule standards.
Food packing materials must be able to meet safety standards. They can be disposable, or they must be able to be cleaned, and unlikely to support microbial growth. The exact materials or design is not specified.
Farmers are required to monitor and respond appropriately to animal evidence in the crops. Reasonable steps must be taken to prevent contamination. Crops in proximity to contamination must not be harvested.
The FSMA “does not require farms to exclude animals from outdoor growing areas,” Dr. Assar said, and “is consistent with sustainable conservation” measures protecting wildlife habitat.
Even in their final configuration, the rules can be confusing. The FDA has released fact sheets to help clarify key issues. There is also an active Technical Advisory Network, available for individual stakeholders to ask questions and receive clarification on the exact requirements. www.fda.gov
“We know that we need to continue the conversation,” Kari Barrett, Office of Foods and Veterinary Medication, said. “There will be more guidance coming.”