Let The Center Guide You Through the FSMA Maze

Ever since the Food Safety Modernization Act (FSMA) was signed into law in 2011 the food industry has been establishing the guidelines and timelines for compliance.  FSMA represents the most sweeping reform to our food safety laws in the past 70 years.  The Centers for Disease Control estimates that 1 in 6 Americans (about 48 million) gets sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases.  

FSMA aims to fundamentally shift the food safety paradigm from reacting to adulterated food after it reaches the marketplace to preventing food from being compromised in the first place.  Steps and methodology include the use of risk-based hazard analysis to identify severity and likelihood of occurrence.  

The FDA, directed by Congress, has created regulations to fully implement four themes of FSMA.  These include:  1) Enhancing the partnerships between domestic and foreign government agencies to create an integrated food system; 2) To ensure that imported food meets U.S. food safety standards; 
3) To conduct food safety inspections at a necessary frequency, respond more quickly when issues arise, and have the authority to force recalls; 4) Create a regulatory system that prevents the occurrence of food safety hazards.

Because FSMA is multifaceted and covers the growing, processing, importing and handling of food, as well as the oversight of animal food, seven major rules were created and are required for FSMA implementation:

  • Preventive Controls for Human Food
  • Preventive Controls for Animal Food
  • Produce Safety
  • Foreign Supplier Verification Programs (FSVP) for Importers
  • Sanitary Transportation of Human and Animal Food
  • Accredited Third-Party Certification
  • Mitigation Strategies to Protect Food Against Intentional Adulteration 

Required implementation dates for compliance are based on company size.  Some of these dates have already passed and are in effect.  Depending on the types of products you manufacture or supply, some or all of the rules may apply to your organization. 

Preventive Controls for Human Food

Very Small Businesses (Compliance Date: September 17, 2018)
Averaging less than $1 million per year in both annual sales of human food plus the market value of
human food manufactured, processed, packed, or held without sale. Three years, except for records to support its status as a very small business.

Small Business (Compliance Date: September 18, 2017)
Less than 500 full-time employees

All Others (Compliance Date: September 19, 2016)

Preventive Controls for Animal Food

Very Small Businesses (Subpart B Compliance Date: Sept. 17, 2018; Subpart C Compliance Date: Sept. 17, 2019)
Less than $2.5 million/year

Small Business (Subpart B Compliance Date: Sept. 18, 2017; Subpart C Compliance Date: Sept. 17, 2018)
Less than 500 full-time employees

All Others (Subpart B Compliance Date: Sept. 19, 2016; Subpart C Compliance Date: Sept. 18, 2017)

don't wait. become Compliant.

In order to successfully implement a program, staff needs to be educated and trained in the regulatory requirements, preventive controls and safe food practices. The Center’s Food Group offers training developed by the Food Safety Preventive Controls Alliance (FSPCA) and FDA to educate food safety professionals on how to meet the new regulatory requirements. The FSMA courses currently offered are:

  • Preventive Controls for Human Foods: The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (referred to as the Preventive Controls for Human Food regulation) are intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. Successful completion of this course is one way to meet the requirement for companies to have a “Preventive Controls Qualified Individual (PCQI).”

  • Preventive Controls for Animal Foods: The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Animal Food regulation (referred to as the Preventive Controls for Animal Food regulation) are intended to ensure safe manufacturing/processing, packing, and holding of food products for animal consumption in the United States. Successful completion of this course is one way to meet the requirement for companies to have a “Preventive Controls Qualified Individual (PCQI).”

The Center’s Food Group also is experienced at developing a CGMP program as well as navigating the waters towards SQF and BRC compliance.

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