Proposed FDA Rule on Protecting Against Intentional Adulteration of Food Products

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One of the key elements of the regulations proposed by the U.S. Food and Drug Administration (FDA) to implement the Food Safety Modernization Act (FSMA) are rules related to prevent intentional adulteration of products. FDA released draft regulations on this topic in December 2013 and has extended the public comment period to June 30, 2014. The Rule would apply to both foreign and domestic facilities that process, pack, or hold food but does not apply to farms. The Rule would cover acts by employees, consumers, or competitors.

FDA has identified four key activities within the food system that are most vulnerable to intentional adulteration:

• Bulk liquid receiving and loading
• Liquid storage and handling
• Secondary ingredient handling
• Mixing and similar activities

Activities that will be exempt from the proposed Rule include; re-packing of food where the original container remains intact, and the processing of food for animals.

Facilities will be required to review their operations and determine if they have any of these covered activities and would be subject to the Rule. Covered facilities would have to prepare a written defense plan, which would include the following:

• Identify actionable process steps
• Develop and implement focused mitigation strategies
• Monitor activities
• Corrective measures that would be taken if mitigation strategies are not properly implemented
• Verify that the plan is reviewed regularly and properly implemented
• Provide training for personnel
• Keep records regarding monitoring and verification

The compliance dates for the Rule would vary by the size of the business:

• Businesses with sales less than $10 million per year would have to comply within three years after the publication of the final rule.
• A business employing less than 500 workers would have to comply with the rule within two years of the publication of the final rule.
• Larger businesses would have to comply within one year of the publication of the rule.

For more information regarding the proposed Rule and other provisions of the FSMA (preventative controls for human food, foreign supplier verification program, and others) consult the FDA website: www.fda.gov/food/guidanceregulation/fsma.

Article written by Rob Neenan, President and CEO, California League of Food Processors

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