The US Food Safety Modernization Act – Progress!

Happy New Year readers!  I hope you all had a fantastic holiday and that you are well-rested and ready to tackle 2013 (bring it!).

For my first posting of the New Year, I’m delighted to report on progress in the wide world of food safety.

As many of you know, I have been closely following the FDA’s progress in implementing the Food Safety Modernization Act (FSMA) – it’s been slow and many of the deadlines provided for in the Act have come and gone.

But lo and behold, on Friday FDA released two proposed Rules – one relating to the hazard analysis and risk-based preventive controls requirements of FSMA and the other relating to the establishment of science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms.

By way of background the FSMA was signed into law by President Obama on January 4, 2011.  It represents the most sweeping reform of US food safety laws in more than 70 years and represents a significant shift in food safety focus from reaction to prevention.

The two rules introduced on Friday are essential to the preventive food safety approach established by the FSMA.  Comments on both proposed rules are due by May 16, 2013.

Preventive Controls for Human Food

One of the key aspects of the FSMA is the requirement that food facilities recognize and address risks associated with their product by implementing requirements for “hazard analyses” and “risk-based preventive controls”.

Unfortunately, the FSMA doesn’t provide any insight into what these hazard analyses or risk-based preventive controls should look like.  FDA was supposed to introduce regulations to establish science-based minimum standards for conducting and documenting hazard analyses and implementing and documenting preventive controls by July 2012, but this deadline has long passed without word from FDA… until now!

On Friday, FDA released for public comment its proposed rule on preventing controls for human food.  The rule proposes to amend FDA’s regulation for Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food to modernize it and add requirements for the establishment and implementation of hazard analysis and risk-based preventive controls by domestic and foreign facilities.

These preventive controls would include requirements for food facilities (with limited exceptions) to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions.

Growing, Harvesting, Packing and Holding Produce

The proposed produce rule sets science-based standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious adverse health consequences or death.

FDA proposes to set standards associated with identified routes of microbial contamination of produce, including: agricultural water; biological soil amendments of animal origin; health and hygiene; animals in the growing area; and equipment, tools and buildings.

The proposed produce rule covers most fruits and vegetables while they are in their raw or natural (unprocessed) state. It would not apply to raw agricultural commodities that are rarely consumed raw, those produced for personal or on-farm consumption, and (with certain documentation) those destined for commercial processing, such as canning, that will adequately reduce microorganisms of public health concern.

Some farms would not be covered by the rule, or would be eligible for a partial exemption based on factors including the monetary value of their food sales and to whom they sell. The partial exemption would still apply certain modified requirements to eligible farms, and could be withdrawn in certain circumstances.

In Other FSMA News…

In other FSMA news, FDA announced along with announcing these proposed rules, that it will “soon” issue its proposed rule on the importer foreign supplier verification program introduced by FSMA and that future proposed rules will address preventive controls for animal food and accreditation of third-party auditors for imported food.

I know a lot of Canadian companies are waiting with bated breath on these ones – I’ll keep you posted.