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April 2013 Handout for Workshops

FDA Implementing

Food Safety Modernization Act

A Discussion 

April 8 & 12, 2013


Overview of Food Safety Modernization Act

Congress enacted FSMA in late 2010; signed by the President in early 2011.  The policy debate was held in Congress in 2010.

There are approximately 20 topics in the FSMA; FDA has primary responsibility for implementing these provisions.  The FDA proposed two regulations in January 2013 in an effort to implement 2 of these 20 topics.  Bottom line – more details will be coming from the FDA in the future as the FDA implements the law enacted by Congress two years ago.

Even though USDA shares responsibility for food safety with FDA (based on statutes enacted by Congress since 1906), the FSMA primarily addresses the FDA’s responsibilities.  USDA’s food safety responsibilities were minimally altered by the FSMA.


Overall Picture

The first U.S. federal food laws were enacted in 1906; nearly all U.S. federal food law has been enacted by Congress AFTER a problem has arisen.

It may be helpful to think of food law categorizing the U.S. food industry intro five sectors and each sector is oversee or regulated differently.

  • Ag input suppliers – FDA, USDA, EPA
  • Agricultural producers – USDA and expanding role of FDA
  • Food Processors
    • USDA Food Safety Inspection Service (FSIS) for meat & poultry processors
    • FDA for all other food processors
    • State government parallels federal government
  • Retail and food service
    • state and local governments (but with guidance from FDA, i.e., the Food Code)
  • Consumers
    • Educate and inform (e.g., food product labeling)

For approximately 20 years, meat & poultry processors (under USDA FSIS) and seafood and juice processors (under FDA) have been required to prepare and implement written hazard analysis critical control point plans (HACCP plans); the Food Code also encourages the food service sector to follow HACCP protocol.  FSMA now requires all other food processors to prepare and implement hazard analysis and preventive controls.

  • FSMA has updated hazard analysis: the next generation
  • FSMA does not change HACCP rules for those previous subject to HACCP
  • FSMA mandates hazard analysis on businesses in the food processing sector that previously were not subject to HACCP

This “Hazard Analysis/ Food Safety Plan” is one of the 20 topics in FSMA; this is one of the two topics addressed with the recently proposed FDA regulations. 

  • This topic also is being referred to as "Current Good Manufacturing Practices" (cGMPs) as well as "Preventive Controls."  Unfortunately, we appear to have four short-hand titles for this topic.

The second recently proposed FDA regulation implements the “produce safety” provision of the FSMA.  Congress included this provision in the FSMA to address the concern that food safety risks arise from on-farm activities in raising and handling fresh/raw fruits and vegetables.  Because these raw commodities are going “directly” to consumers without further processing, the last opportunity to reduce the risk of safety concerns will be on the farm.  FDA has been given responsibility to work with USDA in overseeing these consumer food items even though the activities are “on-the-farm” – an area of the food industry that in the past has been primarily the jurisdiction of USDA.

It also is critical to understand that expectations for the food industry are coming from other food businesses and consumers.  The trend we are discussing today is NOT solely driven by public policy and law.


Hazard Analysis Risk-based Preventive Control Regulation (Food Safety Plan)

Food processors must prepare and implement a food safety plan.

Food safety plan consists of:

Preventive controls consist of:

Similarities between these rules and HACCP regulations


Record keeping rules




Produce Safety Regulation

Coordinated between FDA, USDA and others

Issues addressed in the regulation:

Covered produce:


Record keeping rules:


Similar to GAP rules created by industry



Public Comment

Deadline 16 for submitting comment to FDA on these two proposed regulations is May 16, 2013

Web sites for more information and to submit comments:


Hazard Analysis/Food Safety Plan


Produce Safety



Evolving Food Industry -- a Discussion

Saxowsky’s Opinion:  Expectations for the food industry are imposed as often by consumers and other food businesses as they are imposed by society through government.


  • McDonalds’ Meet our Suppliers:  “Which is why our quality and safety requirements - which meet or exceed USDA standards - are among the strictest in the restaurant industry.”  Copied from
  • Walmart:  As the world’s largest grocer … As of Jan. 31, 2012, 76% of our fresh, frozen, farmed and wild seafood suppliers were third-party certified. An additional 8% had developed the required certification plans.  Copied from
  • USDA, Agricultural Marketing Service, Fruit and Vegetable Program, Specialty Crops Inspection (SCI) Division Audit Programs offers voluntary independent audits of produce suppliers throughout the production and supply chain. SCI Division Good Agricultural Practices (GAP) and Good Handling Practices (GHP) audits focus on best agricultural practices to verify that fruits and vegetables are produced, packed, handled, and stored in the safest manner possible to minimize risks of microbial food safety hazards…
  • In June 2009, the United Fresh Food Safety & Technology Council endorsed a plan to drive harmonization of GAP standards… This plan evolved into the Produce GAPs Harmonization Initiative, an all-industry effort including growers, shippers, produce buyers, government agencies, audit organizations and other stakeholders. The goal of the Initiative is “one audit by any credible third party, acceptable to all buyers”. To achieve this goal, the Initiative has developed food safety Good Agricultural Practices standards and audit checklists for pre- and post-harvest operations, applicable to all fresh produce commodities, all sizes of on-farm operations and all regions in the U.S., and has made them available for use by any operation or audit organization at no cost.  See
  • GLOBAL G.A.P. is a private sector body that sets voluntary standards for the certification of production processes of agricultural (including aquaculture) products around the globe. The GLOBAL G.A.P. Standard is primarily designed to reassure consumers about how food is produced on the farm by minimising detrimental environmental impacts of farming operations, reducing the use of chemical inputs and ensuring a responsible approach to worker health and safety as well as animal welfare… GLOBALG.A.P. serves as a practical manual for Good Agricultural Practice (G.A.P.) anywhere in the world. The basis is an equal partnership of agricultural producers and retailers who wish to establish efficient certification standards and procedures.  See
  • FAO GAP:  A multiplicity of Good Agricultural Practices (GAP) codes, standards and regulations have been developed in recent years by the food industry and producers organizations but also governments and NGOs, aiming to codify agricultural practices at farm level for a range of commodities. See
  • WHO HACCP:  The Hazard Analysis Critical Control Point system (HACCP) has become the universally recognized and accepted method for food safety assurance. The recent and growing concern about food safety from public health authorities, food industry and consumers worldwide has been the major impetus in the application of the HACCP system.  See
  • ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. See



Hazard Analysis Training

2-day training sessions TBA

Contact:  Dr. Rob Maddock, NDSU,  (701) 231-8975



Contact Persons


Dr. Robert Maddock,, (701) 231-8975  

Dr. Julie Garden-Robinson,, (701) 231-7187

Ms Kim Beauchamp,, (701) 231-7187

Mr. David Saxowsky,, (701) 23-7470


North Dakota of Agriculture

Ms Stephanie Sinner,, (701) 239-7211


North Dakota Trade Office

Mr. Dean Gorder,, ‎ (701) 231-1159

Ms Lindsey Warner,, (701) 231-1154


This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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