Update on FSMA, August 2015


The Food Safety Modernization Act (FSMA) was signed into law in January of 2011.  It is the first major reform of America’s food safety laws since 1938 and represents a significant change in America’s approach to food safety, making proactive prevention the primary goal, even though corrective (reactive) measures may be necessary during a food crisis event.  The new law requires all industries associated with human food production and distribution to identify, evaluate, and control food safety risks in order to prevent foodborne illness and reduce costly recalls. The law also expands FDA’s federal authority to develop regulatory oversight for fresh produce and animal feed, as well as setting standards for foreign imports, third party auditors and food transportation.  Finally, the law has provisions to improve laboratory capabilities, foodborne illness surveillance and food safety education, but to date, FDA has not drafted proposals to implement these provisions. While FSMA does not address all of the food safety challenges we are facing in this century, it will improve food production accountability and raise consumer awareness about food safety and foodborne disease.


The seven proposed regulations drafted by FDA are listed below:


  1. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (“Produce Safety Standards”)
  2. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (“Human Food HACCP”)
  3. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (“Animal Feed HACCP”)
  4. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (“Food Defense”)
  5. Sanitary Transportation of Human and Animal Food (“Transportation Rule”)
  6. Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (“Imported Food Auditors”)
  7. Food Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (“Import Verification”)


Most of these seven regulations will be finalized between October 2015 and March 2016. Below is a summary for some of the proposed regulations.

Produce Safety Standards

Proposed FDA Produce Safety Standards for growing, harvesting, and packing of fresh produce are basically contained in the food safety recommendations known as Current Good Agricultural Practices (CGAPs). CGAPs are voluntary practices, policies and procedures that growers and processors can take to prevent contamination of fresh produce.  CGAPs also provide recommendations on the safe use and handling of water application; safe use and handling of manure and biosolids (current manure standard in the Produce Supplemental is woefully inadequate); worker health and hygiene issues, and sanitation practices for field, packing house, and transportation.

Within the past decade, an increasing number of retail grocery stores, restaurant chains, fresh-cut processors, and produce distributors have required produce suppliers, as a condition of sale, to provide evidence of CGAP compliance. This is typically acquired through presentation of a certificate indicating completion of a basic CGAP course; submission of a written food safety (sometimes it is submitted as a checklist), or evidence of passing an independent third party audit.


Human Food HACCP (Hazard Analysis Critical Control Points)

For the last three decades, HACCP has been accepted as the world-wide gold standard for systematically identifying food safety hazards at each point of the farm-to-fork continuum.  HACCP also calls for the development and implementation of procedures and policies to control for identified hazards.


While FDA’s new law embraces the principles of HACCP, FDA has adopted the term “Hazard Analysis Risk-Based Preventative Controls” (HARPC) to indicate that the FDA system goes beyond HACCP to include:

safety controls at specific processing steps;

sanitation practices;

equipment design/maintenance requirements;

prevention strategies to control allergen cross contamination, including labeling.


Further, under FSMA’s new mandatory recall authority granted to FDA, food companies will now be required to develop a recall plan and maintain records about their suppliers.  In the future, food companies may also have to increase pathogen testing of food products and conduct environmental testing of processing equipment/facilities, including transport vehicles.


The law also provides exemptions for smaller sized food facilities, including packers and processors, but there is still debate about the financial limits that will define those exemptions.  However, once these exemption limits are established, including the right to appeal an exemption, FSMA will require all covered facilities to adhere to the new regulations.


Animal Feed HACCP

Federal food laws have considered animal feed as a food, so it has been under federal regulation for many years.  FSMA provides new authority to FDA to regulate animal feed products produced off-farm. Similar to the proposed Preventive Controls for Human Food, companies involved in animal feed production (feed mills and feed ingredient producers) that are not exempted will have to identify potential microbial, chemical, physical, and radiological hazards, and then develop preventative control measures to ensure that contamination events do not occur.


Foreign Supplier Verification


For the first time, importers will have a responsibility to verify that their foreign suppliers have adequate preventive controls to ensure that imported food is safe.  FSMA allows government to government certification and qualified third party certification as two ways to verify the safety of a food product.  FDA must also establish a voluntary program for importers to provide expedited review, but eligibility for this program will be limited. Finally, FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access to a facility, either by the facility itself or by the country in which the facility is located.




For the first time, shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, and food subject to USDA/FSIS requirements must use sanitary transportation practices to ensure the safety of the food they transport.


Food not covered by FSMA:


  • Trans-shipments of food through the U.S.
  • Food not consumed in the U.S. (import for export)
  • Transportation of raw agricultural commodities (RACs) by a farm
  • Shippers, receivers and carriers with transportation operations with less than $500,000 in total annual sales.


Good Transportation Practices:


  • Provisions for vehicle and equipment design, storage and maintenance;
  • Provide temperature control to ensure safety and prevent spoilage;
  • Ensure that transportation operations are conducted in a way that prevents contamination and cross contact;
  • Carrier must supply a vehicle that meets the shipper’s specifications, including precooling;
  • Shipper will verify vehicle precooling and sanitary condition;
  • Carriers must be able to demonstrate to shippers (and upon request, receivers) that appropriate temperature conditions were maintained during transport;
  • Carriers must develop written procedures (SOPs) for cleaning and inspection of vehicles;
  • Training records required under the law will be kept;
  • Carrier personnel engaged in transportation operations must have training that provides an awareness of the food safety problems that may occur during transport, as well as training on proper sanitary practices.



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