The Food Safety Enhancement Act of 2009, expected to be enacted this summer, will give the FDA expanded authority and resources to better ensure a safe food supply.  The Grocery Manufacturers Association supports the Act, which will significantly impact thousands of food facilities both in the U.S. and abroad.

The Act applies only to food manufacturers, processors, packers or holders and does not apply to dietary supplement manufacturers.

Parallel to the Act, the FDA published in the Federal Register on June 11, 2009 a guidance document on compliance to the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act (FDAAA) of 2007.  FDAAA requires that food facilities (manufacturer, processor, packer, and holder) register with the FDA and must report to the FDA within 24 hours a "reportable food".  A "reportable food" is an article of food in which there is reasonable probability that the use of, or exposure to will cause serious adverse health consequences.  The FDA is currently establishing a "reportable food electronic portal" that will be available on September 8, 2009 on the FDA web site under the heading "report a problem".

Below is a numbered summary of key requirements in the four sections of the Act entitled Prevention, Intervention, Response and Miscellaneous. 

Subtitle A - Prevention

1) Manufacturers need to register with FDA (name, address, food category, contact) - 2010 annual fee of $500/facility.

2) Manufacturers need to develop risk based preventive controls such as HACCP (including allergen controls).

3) Manufacturers required to verify suppliers of incoming ingredients to good agricultural practices - may include on-site audits and testing of ingredient.

4) Manufacturers required to have a recall procedure.

5) Manufacturers required to have a procedure for tracing distribution history of articles of food to assure a secure supply chain.

6) Compliance effective date - 18 months after Enactment of Act for most companies but longer times for "small" and "very small" manufacturers.

7) FDA to develop in 18 months safety standards for product/raw agricultural commodities - good agricultural practices.

8) FDA inspections

  Category 1 - manufacturers or processors of raw products of animal origin - 6-18 month inspection time frame.

  Category 2 - manufacturers that process/pack/label - 18-36 month inspection time frame.

  Category 3 - facilities that hold food such as distribution centers - 36-48 month inspection time frame.

9) FDA to establish a tracing system for distribution history of food.

10) Food imported in compliance with Act - certification by country agency or accredited body.

11) FDA has authority to require a recall.

Subtitle B - Intervention

1) FDA required to build surveillance system to assess frequency/source of human illness associated with food consumption.

2) FDA to develop public education program on food safety.

3) FDA to develop rapid method for detection of contaminants in food.

Subtitle C - Response

1) FDA to have product seizure authority for "reason to believe" rather than "credible evidence" of food safety.

2) Civil and criminal penalties for violations relating to aspects of the Act.

3) FDA has the authority to quarantine food if there is the threat of serious adverse health consequences.

Title II - Miscellaneous

1) FDA posting notice of a substances GRAS status.

2) Food misbranded if food label fails to identify the country in which final food processing occurs.

3) Food misbranded if importer fails to register and pay a fee.

4) Whistleblower protection.

UL-STR is a full service provider of testing, audits, inspections and responsible sourcing services for the food and dietary supplements industries.

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