One thing that Mike Taylor, the Food and Drug Administration’s deputy commissioner for foods, said at the start of last week’s public hearing on the Food Safety Modernization Act Produce Safety Rule draft struck me as both prophetic and cliched.
He said “The devil is in the details,” speaking about the agency’s first stab at writing the regulations for the new food safety law.
He’s absolutely right, and United Fresh is finding plenty of devils as we conduct a thorough analysis of both draft rules for produce safety and preventive controls.
Taylor, speaking at the Feb. 28 FDA hearing in Washington, D.C., echoed what other FDA officials have said about trying to get the proposed rules into broad alignment with the principles of the new food safety law — prevention and reducing risk.
FDA deserves a lot of credit for trying to keep the rules targeted, risk-based, flexible and adaptable to evolving science and future risks.
“We think we’ve made a good shot at getting the proposals right,” Taylor said.
United’s two FSMA working groups, assigned to pore over every aspect of the proposed rules, are developing a long list of concerns, and they have the valued perspective that comes from having representatives of many different commodities, production regions, production and handling operations sitting at the table.
United’s working groups have the double advantage of employing some of the produce industry’s most respected food safety scientists, as well as seasoned professionals who understand, first-hand, what it would require to actually put FDA’s proposals into real-world practice.
United president and chief executive officer Tom Stenzel has said that the proposed Preventive Controls Rule alone could force transformational changes onto the produce industry, caused by how FDA seeks to define which industry companies fall under the jurisdiction of which proposed rule.
How does FDA define a “farm” in the Preventive Controls Rule?
That by itself has emerged as a very significant concern for United’s working groups, because it could potentially require a farm’s relatively simple and common production practices to be regulated under the more costly and complicated framework that would be required of a sophisticated post-harvest facility.
The result for hundreds of farms could be regulation as a “mixed” facility that falls under jurisdiction of two rules.
Another serious concern United has with the proposals is the small-farm exemption.
By its own economic analysis, FDA says such an exemption could result in more than 400,000 additional cases of foodborne illnesses every year.
If the object of the new law is to make our food supply safer, and to bolster consumer confidence in the process, having a huge loophole in the standards doesn’t make sense.
If eventually enacted with this small farm exemption, produce buyers might be wise to procure product only from operations that meet the new food safety standards, regardless of farm size.
Another realization from United’s FSMA review process is that FDA desperately needs data to help provide support for the direction they’ve taken in the draft rules.
In so many cases, these proposed rules represent a new frontier of food safety, especially when applied across a variety of commodities, production cultures and other variables.
More than ever, it’s clear that implementing FSMA will have to be a highly collaborative process, involving regulators and stakeholders at every level.
That’s especially true when you consider that we’ve not yet seen FDA’s proposals for regulating foreign supplier verification and accredited third-party certification. All the FSMA regulations, once in effect, will be interrelated in some way or another.
Perhaps never before in our industry has such sweeping and technical rulemaking been so transparent, and FDA deserves a lot of credit for that. They’re clearly working to improving produce food safety on a global scale.
It’s incumbent on all of us to anticipate the many details of this historic process and make sure they get it right.
Ray Gilmer is vice president of issues management and communications for the Washington, D.C.-based United Fresh Produce Association.
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