Food Safety Modernization Act – Update

It took five years from the president’s signature to the publication of the first Food Safety Modernization Act (FSMA) final rule in September 2015.

In the following, we’ve summarized the most significant aspects of the FSMA rules, the Food Safety Plan and how they may impact producers, exporters and the import community (click on links to read more):


  • The Food Safety Modernization Act of 2011 ist the largest overhaul of the US food safety system and Food & Drug Administration’s mandate since the presidency of Franklin Delaneor Roosevelt (the 1930s)
  • Prior to FSMA, the FDA’s food safety policies were primarily geared towards preventing the spread of food poisoning outbreaks. FSMA gives FDA the authority to prevent food outbreaks before they happen and puts the responsibility to prevent food-borne illnesses and outbreaks squarely onto the shoulders of food manufacturers and suppliers.
  • This increases the liabilities to own, operate and manage a food business. Shipping mis-branded or adulterated foods can be very costly, even if no consumer is harmed. The risk for manufacturers and importers residing in the US is financial, reputational and personal: owners and managers may go to jail, if their products caused severe harm to the health of consumers due to negligence or bad intent.


  • FSMA and related laws literally affect anyone in the food industry: Retailers, Manufacturers, Distributors, Warehouse Operators, Transport Agencies, Importers, Exporters, Consultants, Audit Firms (Certification Bodies), and even Foreign Governments.
  • FSMA rules affect all segments of the food and beverage industries, with the exception of seafood, produce, and fruit juices. These three categories are subject to very similar, but separate rules, established in previous decades.   A separate law also regulates low acid canned foods; however, only in regards to microbiological hazards. FSMA also aligns with US Department of Agriculture (USDA) safety protocols guiding the meat industry.

The Eight Segments of FSMA

FSMA rulemaking is structured and implemented in four phases (final rule dates)

  1. Preventive Controls for Human Food (September 2015)
  2. Preventive Controls for Animal Food (September 2015)
  3. Standards for Produce Safety (November 2015)
  4. Foreign Supplier Verification Programs (FSVP) for Importers (November 2015)
  5. Voluntary Qualified Importer Program (November 2015)
  6. Accreditation of Third Party Auditors/Certification Bodies (November 2015)
  7. Transportation of Human and Animal Foods (April 2016)
  8. Strategies to Protect Food Against Intentional Adulteration/Food Defense (June 2016)

Implementation Schedule

The rules for Preventive Controls for Human and Animal Foods are final and must be implemented as follows:

  • Manufacturer
    • Medium to Large Size Businesses by September 2016
    • Small Businesses with fewer than 500 employees by September 2017
    • Very Small Businesses with less that $1 million in sales and assets, with FDA approved records that support their status by September 2018
    • Dairy Businesses subject to the Pasteurized Milk Ordinance by September 2018
  • Distributor/Warehouses/Receiving Facilities:
    • Medium and Large Businesses by March 2017
    • Small Business with less than 500 employees by September 2017

The 5 steps for Preventive Controls:

FSMA Preventive Control rules are essentially about risk based Current Good Manufacturing Practices (CGMP) Most established and experienced food manufacturers around the world will already employ CGMP in some form or another, especially if they are certified by standards under the Global Food Safety Initiative. Risk-based preventive controls include:

  1. hazard analysis and risk assessment
  2. preventive controls
    1. the process
    2. food allergens
    3. sanitation
    4. supply-chain program
  3. verification of these controls and corrective actions as necessary
    1. monitoring
    2. corrective actions
    3. verification
  4. recall plan
  5. record keeping requirements (all of the above)

Hazards? What Hazards?

  • Allergens: The failure or accidental mistake to declare all allergens present in a food is by far the Number One reason for recalls in the US
  • Microbiological contaminants: Interestingly, spices imported from around the world are most frequently identified as sources of contaminated food. Herbs, sprouts and produce follow suits as frequent carriers of dangerous bacteria, such as salmonella, listeria and E coli. FSMA mandates the verification of the entire supply chain!
  • Chemical contaminants, such as pesticide and herbicide residues or residues of chemical solvents or detergents, may be detected in food.
  • Physical hazards in food, such as glass, metal, plastic
  • Sanitation: The FDA has now the power to revoke the registration and order the shutdown of food facilities with unsanitary conditions or lack of proper cleaning procedures. This happens more frequently now.
  • Environmental contamination: This is especially important for processors of produce, but also applies to areas with a lot of wildlife, water pollution or animal diseases
  • Intentional contamination. Do you have procedures in place that prevent disgruntled employees or outsiders to enter your food production areas and contaminate your food intentionally?

Investment in People and Procedures (Preventive Controls)

  1. Employee Qualification: FSMA mandates that you have to employ a “qualified individual(s)” to conduct preventive controls and write a food safety plan. A random employee assigned to the task, including a senior manager, do not qualify, if he or she has not undergone extensive training. Similarly, all employees directly involved in “manufacturing, processing, packing or holding food” need to be qualified to perform their assigned duties.
  2. Education and Training: Qualified Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.
  3. Product testing & Environmental Monitoring FSMA specifically mandates product testing and environmental monitoring for all manufacturers, on a risk based frequency. The results of the tests have to properly recorded and kept on file.

Written Food Safety Plans and Record Keeping

  • All steps of the hazard analysis and preventive controls, monitoring and verification, corrective action, and recall plans have to be documented and updated every three years.This is part of the FSMA’s record keeping mandate.
  • The Written Food Safety Plan must or should be shared with you importer of record. FSMA obliges importers to verify the safety of the products they bring into commerce in the US under the Foreign Supplier Verification Program
  • Also share the results of all food safety and quality audits with your importer. The audit schemes benchmarked under the Global Food Safety Initiative, such as IFS, BRC, SQF or FSSC 22000, are likely to be FSMA compliant (see below).

Foreign Supplier Verification and, if applicable, Voluntary Qualified Importer Program

Importers will be obliged to verify the food safety of their export partners on an annual basis and keep records of their verification. Specifically, importers have to

– Determine known or reasonably foreseeable hazards with each food

– Evaluate the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance

– Use that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities

– Conduct supplier verification activities

– Conduct corrective actions

More specifically:

  1. Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
  2. Importers are required to develop, maintain and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers.
  3. Importers will be obliged to inspect foreign manufacturers facilities at least once a year if the food they import is deemed to be high risk, i.e. could cause “serious adverse health consequences or death to humans or animals.”
  4. Like domestic and foreign manufacturers, importers will also be subject to controls by FDA inspectors.
  5. Importers or the designated manufacturer agent will be liable for all costs related to FDA mandated recalls and re-inspection of facilities, if these failed the first inspection.
  6. Importer investment into verification, record keeping and qualified food safety personnel will likely increase the costs of doing business for many small importers (and may limit the number of available importers for exporters in the long run)
  7. Manufacturers samples and food imported for research purposes is not subject to Foreign Supplier Verification, but need to be produced according to FSMA standards.
  8. FDA will more vigorously target and pursue smugglers of food who illegally introduce imported food into commerce that could have a potential public health risk.

Third Party Accreditation and the Global Food Safety Initiative

This (not yet final) rule is all about enlisting non-governmental organizations, foreign governments, accreditation agencies and audit/certification bodies to control food safety in lieu of the FDA. The agency already has to few inspectors and limited budgets. The question is: who will be an accredited third party and what will that cost the accredited organization.

For example, most consumer packaged food and beverage companies are subject to retailer audits according to four major standards or schemes:

The accreditation of the private standards holders and their audit/certification bodies may fulfill the FSMA requirements for the audited firm and importer, which will greatly lower the risk for the imported or distributed foods.

However, the current draft rules suggest that a third party may have to pay in $16,000 per year for the accreditation and have to submit the audits to the FDA based on request. Many foreign governments and private organizations view these requirements as potential trade barriers and sticking points for compliance – issues that will likely be resolved before the final rules come out.