Modernizing cGMPs

Current Good Manufacturing Practices (cGMP) were first promulgated by FDA in 1969, and the last time they were updated was in 1986. Since that time, the food supply system and American dietary habits have changed, so FDA is in the process of revising cGMPs to include the latest science and prevention-based practices.

“Certainly, many changes have occurred in the food industry since 1986, most notably in the availability of ready-to-eat foods, including fresh-cut produce,” said Paul South of the Division of Plant Product Safety, Office of Plant and Dairy Foods in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). South spoke to members of the industry at the United Fresh Public Policy Conference, Fresh-Cut Processor breakout session.

When the modernized cGMPs are put in place, fresh-cut processors will be required to comply with the updated practices when they are developed, based on risk factors such as increased demand for fresh-cut products, lack of a kill step, the potential for pathogen growth and the number of illness outbreaks associated with fresh-cut produce. The future document will continue to cover fresh-cut produce, but pick up where the produce safety rule leaves off, South said.

FDA began working on the cGMPs in 2002 by forming a working group, which determined that modernization of cGMPs was needed. Then in 2003, the agency initiated the research, starting with a literature review, expert identification of problems and controls and an analysis of food recalls from 1999 to 2003.

The next year, FDA posted the initial report and published notes in the Federal Register, a required step in creating new regulations. Public comments from the report amounted to more than 700, South said. In 2005, FDA published a white paper titled “Food cGMP Modernization – a focus on food safety,” which highlighted a few areas that needed to be addressed: an employee training requirement, written allergy control measures, written environmental pathogen controls and written sanitation procedures for food contact surfaces and machinery. The White Paper also asked for public comments on time and temperature monitoring and reporting.

Since 2005, FDA has conducted additional research to identify shortcomings of the cGMPs and to identify a baseline for domestic facilities. The agency surveyed 2,700 plants to identify what measures they have in place currently. FDA is studying the results of that survey, and a report should be available next year on the findings. In addition to the study, FDA has received additional expert elicitation and conducted an analysis of food recalls from 2008 and 2009 to see if they line up with the 1999 to 2003 data. The agency also has looked at reported incidents in the Reportable Food Registry, South said.

As part of its research, FDA started a finished testing project to determine a baseline for pathogens in retail bagged salads. During that study, FDA found occurrences of dangerous pathogens in bagged salads taken from retail shelves. That led the agency to intervene and deviate from study protocols, and resulted in five product recalls with no illnesses. The modernized cGMP might not include a final sampling practice, but South said the agency may continue to conduct sampling based on those findings.

CFSAN is drafting a proposed regulation that includes changes to the cGMPs, but there has been no date set for publication in the Federal Register. Once it is published, there will be a comment period before the final rule is put in place, and South said the industry should be involved in the process.

“We would hope, and urge, that we get comments from the fresh-cut industry on the proposed regulation and other regulations,” he said.

Although South couldn’t speak about the specifics of any future regulations, he did say processors should expect to see prevention-oriented food safety principles, which was an area President Obama identified in his Presidential Food Safety Working Group.

Work on modernizing cGMPs continues at FDA, but likely won’t be released until FDA’s role is clarified by Congress. The Food Safety Modernization Act was unlikely to pass the Senate, and unless there was unanimous consent it would not likely pass during a lame duck session. So the agency is waiting to see what Congress decides, and how funding for food safety directives will shake out.

-by Scott Christie, Managing Editor



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