The United Fresh Produce Associationis working at warp speed to submit ideas by Sept. 16 to improvetwo proposed Food and Drug Administration (FDA) regulatory rules designed to implement the Food Safety Modernization Act(FSMA).
The FSMA is the first major change in U.S. food safety laws in about 70 years. President Obama signed the Congress-passed measure into law in 2011.
Outgoing United Fresh Board Chairman David Krause calls the FSMA law “a landmark food safety initiative.” Krause is president and chief executive officer of Paramount Citrus in Delano, Calif.
The two proposed FDA measures include the produce safety standards rulewhich aims to further expand food safety at the farm production level. The preventative controls for human food ruletargets improved food safety measures during post-harvest handling and processing.
Together, the proposed regulations total more than 1,000 pages.
On Jan. 16, the FDA published the proposed rules in the Federal Register Jan. 16 which launched a four-month public comment period. The comment deadline of May 16 was extended after about 90 agricultural groups asked for more time to study the rules and provide feedback.
Agricultural groups, consumer groups, and others interested in food safety are expected to comment on the proposed regulations. Consumer groups are expected to ask for even stricter rules than those proposed by FDA.
The FSMA proposed rules and irrigation reform were the front burner issues discussed during the 2013 United Fresh convention held in San Diego, Calif. in May. The event drew about 5,000 people, including produce growers and shippers, wholesalers and distributors, fresh-cut processors, and retail food service.
During a FSMA breakout session for growers, United Fresh Chief Executive Officer Tom Stenzel discussed how the rules would impact the produce (fruit and vegetable) industry.
Stenzel called the government’s proposed rules a “one-size-fits-all’ approach, placing the same food safety regulations across all crops and business sectors in the produce farm-to-fork food chain.
“The challenge is the FDA doesn’t understand as much about the fruit and vegetable industry as they should,” Stenzel said.
In some areas, Stenzel says the regulations are not needed which could result in unjustified and costly regulations.
Stenzel said, “Some regulatory requirements for the citrus industry would apply equally to the leafy greens industries while in reality each sector has completely different food safety risk profiles.”
Stenzel says the rule feedback which United Fresh provides to FDA on this and other issues needs scientific research to support the conclusion.
United Fresh strongly supports food safety improvements to safeguard the nation’s food supply, the farm leader says, but regulation should be applied only where needed – not a blanket approach for the entire industry.
Produce safety rule
Regulations in the proposed produce rule would impact farms which grow, harvest, pack, or hold most raw agricultural commodities; produce grown in the U.S. and internationally; and farms with annual sales greater than $25,000.
Farms with sales less than $25,000 annually would be exempt from the regulations.
Stenzel has a major beef with this exemption. The farm leader voiced support for smaller farms, yet believes all produce farms, regardless of size or income, should follow the same food safety standards.
Stenzel quipped, “Scientists on the United Fresh staff say bacteria don’t know what size farm they are living on – a big farm or a small farm – 1 acre or 100 acres.”
“We want to make sure everyone growing produce is doing so safely,” he explained.
The small farm exemption was a hotly-contested issue during the FSMA deliberations in Congress. The so-called Tester Amendment, supported by Sen. Jon Tester of Montana, was adopted in the final measure. The amendment had strong vocal proponents and opponents.
The produce safety rule includes several other exclusions including:
- Produce consumed on the farm by the family which grows the crop;
- Certain produce rarely consumed raw (the ‘potato provision’); and
- Fruits and vegetables which undergo thermal processing, including a bacterial kill step.
An example of produce thermal processing is processing tomatoes grown for ketchup. The tomatoes are cooked and heated to kill any bacteria.
Speaking of bacteria, the FDA rule identifies five major routes or sources of microbial contamination in food. These include agricultural water; biological soil amendments of animal origin; worker health and hygiene; equipment, tools, buildings, and sanitation; and domesticated and wild animals.
Stenzel agrees with FDA’s source list of microbe sources.
Preventative controls for human food rule
FDA’s second proposed rule – preventative controls for human food - would apply to facilities which manufacture, process, pack, or hold food grown in the U.S. and internationally for human consumption.
In general, this includes operations registered with the FDA under Section 415 of the federal Food, Drug, and Cosmetic Act.
The rule would require a hazard analysis and evaluation with risk-based preventive controls. The rule would tighten down on food allergen issues, sanitation, cross-contact and cross-contamination prevention, labeling, product recalls, and other areas.
Stenzel says many produce growers believe they would fall only under the produce rule, but in many cases would also have to follow the preventative controls regulations. If a farm has a packing shed or the produce is placed in a box, the grower must follow the preventative control regulations.
“This is a much more detailed and aggressive regulatory approach for our industry and for packing and warehouse-holding facilities,” Stenzel said.
“In the case of a packing shed for whole produce, these procedures are not necessary to protect public health. We will make this case to the FDA.”
Food manufacturing and processing facilities and the fresh-cut produce business already follow preventative control procedures as part of risk mitigation.
Prior to submitting its official comments, United Fresh will publicly release a draft of its ideas to gain industry feedback. The association could tweak the comments before the submission to FDA.
Stenzel concluded, “The produce industry has hundreds, if not thousands, of different packing facilities and warehouses. We want them to be safe. We want to make sure that the (FDA) standards are not applied where there is no public health risk.”
Will Steele, United Fresh’s grower-shipper board chairman, called the diversity of the produce industry and the complexity of the FDA proposed rules a monumental undertaking.
“The stakes for our industry could not be higher,” Steele said.
Three more proposed FSMA proposed rules are forthcoming which will address foreign supplier verification, accredited third party certification, and preventative controls for animal food.
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