The U.S. Food and Drug Administration (FDA) released two proposed food safety rules under the Food Safety Modernization Act (FSMA) on Friday. The proposed standards come two full years after President Obama signed the act into law in January of 2011.
One of the two proposals is aimed at preventing outbreaks of foodborne illness, a subject that's gotten a lot of attention in the past several years due to the dozens of illnesses and deaths caused by contaminated spinach, peanuts, cantaloupe and beef. The draft rule, called Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, would require many foreign and domestic food production facilities to have written food safety plans in place. The plans must include "hazard analysis; risk based preventative controls; monitoring procedures; corrective actions; verification; and recordkeeping." The FDA would then sign off on the plans and ensure they are being implemented.
The other proposal applies to the produce industry in particular, and is called the Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption Proposed Rule. It would set standards around the routes of microbial contamination of fruits and vegetables, such as agricultural water; biological soil amendments of animal origin (like manure); human health and hygiene; domesticated and wild animals; and equipment, tools and buildings. Some farms would be exempt from complying with this rule, based on their sizes and food sales.
The FDA also announced on Friday that it expected to "soon issue a proposal on importer foreign supplier verification, proposed rules addressing preventive controls for animal food and accreditation of third-party auditors for imported food."
President and CEO of Grocery Manufacturers Association, Pamela Bailey, applauded the release of the new rules on behalf of its 300 members in the food, beverage and consumer product industries:
Consumers expect industry and government to work together to provide Americans and consumers around the world with the safest possible products. FSMA and its implementation effort can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal.
Bryan Silbermann, president and CEO of Produce Marketing Association (PMA), an industry group representing 2,500 companies in produce and floral production, retail, distribution and foodservice, released this statement saying he was eager to assess the proposals:
In the coming days we’ll provide an online summary of the proposed rules and will be scheduling a free webinar for members with FDA and PMA experts. And, over the next few months, we’ll read and analyze the proposed rules and work with PMA’s volunteer leaders to submit commentary to the FDA. Once the FDA reviews all the comments submitted, they’ll revise the rules in a final form which will include a timeline for implementation.
Dr. David Gombas, senior vice president of food safety and technology for the produce trade association United Fresh, said his company was also happy with the draft rules. Here's part of the company's response:
We will be analyzing the proposed rules to ensure that they draw upon the principles we have supported throughout the development of the FSMA. The proposed rules must be: 1) commodity-specific, based on best available science; 2) risk-based; 3) consistent no matter where produce is grown or packaged, in the U.S. or imported, large or small operations; and 4) flexible to allow for advances in science and production technology. We are committed to ensuring that those critical provisions, and others, will be integrated into the final rules going forward.
On his blog, Bill Marler, an attorney who began litigating foodborne illness cases in 1993, cautioned that the new proposals were not a cure-all.
“You can set all the rules you want,” he wrote. “The real question is, ‘Are all the players in the industry going to observe them? Where’s the mechanism to make sure the companies that might ignore them are caught before an outbreak happens?’”
The FDA says it plans to hold regional public meetings to get input on the proposed rules. The public has 120 days to comment on the proposals.