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History of FSMA

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The Food Safety Modernization Act, or FSMA is the first food safety regulation overhaul in over 70 years! The increasing number of reported foodborne illnesses nationwide helped spark FSMA's initiative and continues to drive its progression today.

The Making of FSMA

  • December 20th, 2010: The name FSMA was born. The Food Safety Modernization Act was passed by Congress, mandating the FDA to update its food safety regulations in order to improve the safety of food for its consumers in the United States
  • January 4th, 2011: President Obama signed FSMA into law. The first overhaul of food safety regulations since the Food, Drug and Cosmetic Act of 1938.
  • Initial Timetable: Had parts being implemented immediately and other parts implemented over a 3 year period but, FDA has not been able to meet this timeframe and this is now a 6-8 year plan.

Food Safety Modernization Act 2010

This act is segmented into four titles altogether designed to support the essential food safety protocols for implementation, in order to ultimately reduce the occurrence of foodborne illness within the United States. Furthermore, each title is composed of supporting section. For example

  • Title I - Designed to improve capacity to prevent food safety problems
  • Title II - Designed to improve capacity to detect and respond to food safety problems
  • Title III - Designed to improve the safety of imported food
  • Title IV - Includes miscellaneous provisions

Proposed Changes to FSMA

Due to the immense amount of feedback FDA received to key components of the law, they proposed changes (September 2014) to several of the rules initially put in place. Along with these proposed changes came an additional 75 days for stakeholder commentary. The affected sections and their implementation dates are shown below:

  • Section 103: Preventive Controls for Animal Foods
  • Section 103: Preventive Controls for Human Foods 
  • Section 105: Produce Safety
  • Section 302: Foreign Supplier Program

Implementation Dates

The FDA was mandated by the Federal Judge of US District Court Northern California to set and meet a timetable for various sections of FSMA. Consequently the FDA announced implementation dates for the proposed respective sections:

Section  Name  Implementation Date
103 Preventive Controls (Animal and Human Foods)  8/31/2015
105 Produce Safety    10/31/2015
302 Foreign Supplier Verification Program (FSVP)   10/31/2015
307 Third Party Auditor    10/31/2015
111 Sanitary Transportation of Human and Animal Food 3/31/2016 
106 Intentional Adulteration 5/31/2016

Compliance Timelines

Each proposed rule has its own compliance timeline from the assigned implementation date referenced above. Obtaining compliance to these rules can cause capital expenditures and the need for additional resources. For this reason, the FDA has developed a revenue based structure for compliance timelines, respectively fostering the flexibility needed for smaller businesses to effectually comply with the law.

Section Rule FDA's Final Rule Deadline Non Small  Small Business  Very Small Businesses
Preventive Controls (103)  8/31/2015  *1 Year  *2 Years *3 Years 
Produce Safety (105) 10/31/2015  2 Years  3 Years 4 Years
Foreign Supplier Verification (302) 10/31/2015 6 Months After Preventive Control Deadline 6 Months After Preventive Control Deadline 6 Months After Preventive Control Deadline
Food Transportation  (111)  3/31/2016  1 Year  2 Years  Not Applicable
 Intentional Adulteration (106)  5/31/2016  1 Year  2 Years  3 Years

What Size of Business are you?

Visit the respective *Animal Food and Human Food pages under FSMA Compliance to see the classification of business size (Non-Small, Small and Very Small) of each rule to determine when you will be held responsible for FSMA compliance.

Questions?

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