See also: "FDA rolls out first rules on federal food safety law."
The costs to fruit and vegetable growers for complying with the newly proposed produce safety regulation have been estimated at more than $30,000 annually for large farms and about $13,000 per year for smaller farms.
Those figures come from the Food and Drug Administration’s cost-and-benefit analysis of the produce safety rule regulation, one of two proposed Food Safety Modernization Act components released Jan. 4.
The FDA estimates the new food safety regulations on growing and packing will prevent 1.75 million foodborne illnesses annually.
The proposed rule imposes new standards on growers for worker training and hygiene, agricultural water purity, biological soil amendments, equipment, tools and buildings. Exemptions to the proposed rule were carved out for produce commodities rarely consumed raw, produce used for personal or on-farm consumption, produce that receives a “kill step” to reduce the presence of microorganisms and farms with average annual sales of $25,000 or less.
Other growers with sales less than $500,000 (and who sell mostly to consumers or nearby retailers and restaurants) can qualify for exemption or fewer mandates — as outlined in the Tester Amendment.
The FDA calculates the benefit from reduced foodborne illnesses to be $1.04 billion. The FDA estimates the cost of the legislation to domestic farms at $460 million annually and $171 million a year for foreign farms. Net benefit was calculated to be $406 million annually.
Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said it is hard to predict foodborne illness outbreaks. He said one of the benefits of the regulation is greater consumer confidence in produce safety and less damage to the industry from recalls.
Taylor said FDA plans to collaborate with the produce industry, state agriculture departments and University Extension agents to educate growers on the new requirements and to provide technical assistance and training.
Margaret Hamburg, commissioner of the FDA, said in a Jan. 4 news conference that the produce safety rule will allow small and large farms to organize themselves around one set of standards, rather than multiple standards from multiple buyers.
“Now there is going to be a uniform, agreed-upon approach that I think will both be driven by the best possible science and be agreed up and enforced at various levels, both local, state, industry and by FDA,” she said.
The produce safety rule was one of two rules released on the two-year anniversary of President Obama’s signing of the federal food safety law.
A second rule released Jan. 4 is the regulation designed to prevent foodborne illnesses originating from food facilities.
The proposed rules are available for public comment for the next 120 days, according to a news release from FDA. After the comment period, the FDA could take up to a year to publish final rules, Taylor said.
Industry leaders said they immediately began reviewing the lengthy proposals.
Mike Stuart, president of the Florida Fruit & Vegetable Association, said Jan. 4 he was glad the produce safety rule was finally out.
“The industry has been in limbo for the past year waiting for the rules to come out, so at least now we have begun the process of looking at them and over the next 120 days we will talk to membership and groups and around the country to provide some input on what we see,” he said.
The 547-page produce safety rule is so long that average growers may have difficulty reviewing the proposal, said Chris Schlect, president of the Yakima, Wash.-based Northwest Horticultural Council. He predicted the 4-month comment period may be extended because of the length of the proposed rules.
“The fear I have is not so much for the big operations because they have people on staff trained to deal with these kinds of things,” he said.
While the smallest farms are exempt from regulation by the food safety law, Schlect said mid-sized family operations might be driven out of business by the regulation.
Schlect said he hopes the FDA provides flexibility for low-risk commodities, including apples and pears.
Officials for PMA and United Fresh declined comment until they could review the proposals in-depth.
Produce safety rule
The produce safety rule proposes enforceable safety standards for the production and harvesting of produce. This rule proposes science- and risk-based standards for fruits and vegetables, according to the release.
The produce safety rule proposes that larger farms comply within 26 months after the final rule is published in the Federal Register, according to the FDA release. “Small” and “very small” farms would have more time to comply, according to the release. All farms will have more time to comply with water quality requirements.
Food facilities rule
The 680-page proposed rule on food facilities requires makers of food to be sold in the U.S., (whether domestic or imported), to develop a formal plan for preventing foodborne illness, according to the FDA release.
The proposed rule would establish requirements for a written food safety plan, hazard analysis, food safety measures to prevent contamination, monitoring, corrective actions, verification and associated records.
The agency said it is proposing that many food manufacturers be compliant by a year after the final rules are published; small and very small businesses would be given additional time.
FDA’s implementation of the proposed regulations will require additional funding, Taylor said.
Hamburg said additional rules on imported food and accreditation standards for third-party food safety audits overseas.