New Schedule Set for Issuance of FSMA Rules

By Ricardo Carvajal –

FDA entered into a consent decree with the Center for Food Safety that specifies new deadlines for the agency’s submission of final rules implementing FSMA to the Federal Register for publication.  The consent decree marks the latest chapter in a case that started in August 2012 and wound its way to the 9th Circuit amid last year’s partial government shutdown.  The new deadlines corresponding to each rule are listed below:

August 30, 2015

• Preventive Controls for Human Food (FSMA Section 103(a) and 103(c))
• Preventive Controls for Animal Food (FSMA Section 103(a) and 103(c))

October 31, 2015

• Foreign Supplier Verification Program (FSMA Section 301(a))
• Produce Safety Standards (FSMA Section 105(a))
• Accreditation of Third Party Auditors (FSMA Section 307)

March 31, 2016

• Sanitary Transport of Food and Feed (FSMA Section 111)

May 31, 2016

• Intentional Contamination (FSMA Section 106(b))

Under the terms of the decree, FDA agrees “in good faith” to “make every effort” to meet the above deadlines.  However, the deadlines can be extended by mutual agreement between the parties, or through modification by the court based upon a request by FDA that must “show good cause and/or exceptional circumstances warranting the delay, and address the effect of the delay on the public health and safety, among other relevant considerations.”