It takes a village, or a committee, to tackle a new 680-page proposed regulation from the FDA.
Wisconsin Milk Marketing Board, proactive as ever, gathered an expert committee in 2011 to analyze new regulations that FDA planned to launch after Congress passed the Food Safety Modernization Act in December 2010.
In January 2013, 14 months after WMMB formed its action committee, FDA finally released its landmark food safety regulations. Good thing there was milk and cookies in the meeting room.
The proposed regulation, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, has been shortened to the “Preventative Controls” regulation by these insiders.
FDA is taking comments on this massive proposed rule until May 16, 2013.
In a nutshell, FDA’s new food safety regulations are “HACCP Plus” and dairy is better prepared than most food manufacturers for this paperwork storm.
Dairy manufacturers have been preparing and executing food safety plans including prerequisites and critical control points (the CCP in HACCP) for at least 20 years. The new FDA regs make food safety plans mandatory, and add several new components to the workload.
The Preventative Controls regulation notes five key parts to a written food safety plan:
1) Hazard Analysis (the HA in HACCP). Hazard analysis answers the question – What risks are we looking for? – and must include a look at biological hazards, chemical hazards, physical hazards (like metal fragments) and radiological hazards. Dairy is familiar with identifying hazardous microorganisms, but the proposed regulation notes pesticides as a chemical hazard.
Companies must identify if a hazard is ‘”reasonably likely to occur” and can use existing scientific research to include or discount a hazard. WMMB’s expert committee will look at existing research to determine dairy’s likely hazards.
2) Preventative Controls. FDA coined this term, and it’s almost interchangeable with critical control points (CCPs). Pasteurization, for example, will be a preventative control and it’s dairy’s favorite CCP. But FDA will consider more current actions, such as a company’s sanitation plan or its product recall plan or its allergen control plan, to be preventative controls too.
3) Monitoring. Preventative controls need written plans that describe the type of monitoring, frequency of monitoring and documentation of monitoring. Buy stock in a paper company.
4) Corrective Actions. Improving and correcting the procedure for a preventative control is logical, and many dairy manufacturers already log their corrective actions.
5) Verification. Companies need to provide scientific proof that preventative controls work. Industry organizations, including WMMB’s expert committee, will likely gather this data to prove that common controls are science-based. Verification also means that companies will verify that they are monitoring their systems, calibrating equipment (such as a pasteurizer) and documenting everything for regulators.
The new regulation allows FDA access to all documents created by this regulation, including the ability to photocopy documents. Members of WMMB’s committee urged manufacturers to remove trade secrets (make procedures, cooking times) that aren’t needed in these food safety records.
Consumer media sources noted that FDA was made to remove mandatory food safety testing from these proposed regulations, likely due to the cost industries would face. But in its official statement on the regulation, FDA declared that it wants comments on “other elements of a preventative controls system… including: a product testing program, an environmental monitoring program and a supplier approval and verification program.”
Industry experts on WMMB’s committee expect to see product testing and environmental testing when FDA writes the final rules. Like other aspects of this regulation, companies will likely have to assess which testing is appropriate, then justify their decisions using today’s scientific data and accepted testing regimens.
FDA will collect public comments by May 16 and may take up to a year to offer a final regulation. Then, large companies (over 500 employees) will have a year to build their new food safety plans with hazards analyzed, preventative controls in place, monitoring plans, correction actions plans and verification steps. Companies with less than 500 employees will gain an additional year to comply.
In the end, this “Preventative Controls” regulation lays heavy emphasis on finding science to justify the hazards that food manufacturers will address (and dismiss) and demands documentation of everything. But the industry has built a record of success in food safety planning, and is well-positioned to meet the demands of FDA.
Consider attending the “Food Safety Modernization Act – Are You Prepared?” seminar on Day 2 (April 18) of the Wisconsin Cheese Industry Conference in La Crosse, WI. FDA and cheese industry food safety experts will further your understanding of this mandatory regulation. JU
John Umhoefer has served as executive director of the Wisconsin Cheese Makers Association since 1992. You can phone John at (608) 828-4550; Fax him at (608) 828-4551; or e-mail John Umhoefer at
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