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FDA Releases New FSMA Rules

WASHINGTON — The Food and Drug Administration on Friday released two long-awaited rules for produce growers and processers related to the Food Safety Modernization Act.

The proposed rules, which had been stalled in the White House Office of Management and Budget since late 2011, specifically concern actions growers must take at the farm and packing level and prevention plans processers must put in place to avoid the types of foodborne illnesses that hospitalizes as many as 130,000 Americans each year.

For growers, the produce safety rule outlines standard safety practices related to water, worker hygiene, materials that are added to the soil, such as manure or compost, wild animals entering fields, and conditions in packing houses. 

The hazard analysis and risk-based preventive controls regulation requires processers to create, implement and monitor a Hazard Analysis and Critical Control Points plan. HACCP plans are currently the food safety standard for seafood, juices, meat and poultry. 

“While the FDA responds very quickly and effectively in response to outbreaks, containing them and finding their source and taking other necessary action, we really need to do more than react after the fact,” FDA commissioner Margaret Hamburg said in a media briefing. “Preventing problems before they cause harm is not only common sense, it is the key to food safety in the 21st century.”

Though officials were hesitant to promise any specific results from enacting the regulations, FDA deputy commissioner for foods and veterinary medicine Michael Taylor said, “We estimate as many as a million and a quarter illnesses prevented.”

It will be some time before the produce industry must actually come on board with these rules, however. The proposed regulations are now subject to a 120-day public comment period, after which the FDA will review the comments and prepare a finalized set of rules. Taylor said the process could take up to a year.

“So I think it’s important for people to understand that we are building a new system,” said Taylor. “It will happen over time. The private sector continues to move in this direction in parallel. And so I think we’re both making progress as we go and also establishing a system for a long-term future that will be more effective and efficient.”

The rules can be found on the FDA website

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