FSMA Already Late for 2012 Deadlines, Passes 1-Year Anniversary, According to FDAImports.com

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This month marks the 1-year anniversary of President Obama signing into law the Food Safety Modernization Act (FSMA). One of the key implementation dates from the Act was January 4th, 2012, by when the FDA was required to publish a variety of documents and reports. That deadline has passed with nothing yet issued by the FDA, according to FDAImports.com

Although it can feel frustrating to wait on an overstuffed federal agency to provide more details about how it will soon dramatically enhance its regulatory authority...It is better that it take longer and perhaps get it right.
-Ben England

This month marks the 1-year anniversary of President Obama signing into law the Food Safety Modernization Act. One of the key implementation dates from the Act was January 4th, 2012, by when the following significant steps were to have been taken by FDA:

  •     Guidance for very small business exemptions from HARPC requirements
  •     Updated Good Agricultural Practices guidance for fresh produce
  •     Guidance related to intentional adulteration of food and mitigation strategies
  •     “National Agriculture and Food Defense Strategy” issued to Congress and public
  •     Study concerning unique identification numbers for food facilities and brokers
  •     Food allergy guidelines for schools and early education (with Dept of Ed)
  •     Designation of “high-risk foods” for which additional recordkeeping would be required
  •     Designation of 5 “Food Safety Centers of Excellence” to respond to outbreaks
  •     Grocery store recall posting requirements
  •     Regulations for a Foreign Supplier Verification Program

This list does not include all the items Congress instructed FDA to accomplish by January 4th but it does contain some of the most important action items related to food safety. So how is FDA doing? The agency has missed the anniversary deadline for these important items as none have yet been accomplished. Although this is not the first time the FDA has struggled to stay on top of its implementation deadlines for new regulatory requirements, it does officially mark the first set of missed benchmarks for 2012 related to the Food Safety Modernization Act.

“Although it can feel frustrating to wait on an overstuffed federal agency to provide more details about how it will soon dramatically enhance its regulatory authority – I do not find it to be too frustrating”, said Ben England, Founder and CEO of FDAImports.com. “In one sense, however, these are very complicated guidances and regulations FDA is expected to issue. It is better that it take longer and perhaps get it right.”

The next due date in FSMA’s implementation timeline is July 4th of this year where more guidance documents are due from FDA concerning traceability and tracking, consumer information reporting, a third-party auditing program, and more. The final implementation dates for FSMA are January 4th, 2013 and July 4th, 2013.

Sources:
http://www.fdaimports.com

http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm
FDAImports.com is an FDA consulting firm helping U.S. and foreign companies navigate through and meet complex FDA regulations for marketing and importing foods, dietary supplements, drugs, cosmetics and medical devices. Benjamin L. England, Founder and CEO, is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Contact us at http://www.fdaimports.com, call (410) 740-3403 or contact Jon Barnes at jrbarnes [at] fdaimports.com.

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