What does FSMA stand for?
FSMA stands for Food Safety Modernization Act.

The History of FSMA The FDA’s Food Safety Modernization Act (FSMA) is being called the most sweeping reform of U.S. food safety laws in more than 70 years. It was originally signed into law by President Obama on January 4, 2011, and in the years since, FDA has been working to develop the final rules that the act requires them to implement. The focus of the act is more effective prevention of food safety issues in the U.S. food supply.

FSMA is a comprehensive top-to-bottom overhaul of the United States food safety regulatory framework. FSMA will touch every segment of the produce business supply chain from farm-to-fork. The U.S. Food and Drug Administration (FDA) has proposed seven major regulations. The proposed regulations will affect how produce is grown, packed, processed, shipped and imported into the U.S. The Food Safety Modernization Act is changing the culture of the food safety system in the United States.

FSMA shifts the focus of the FDA to ensuring food safety through prevention of microbial contamination rather than just reacting to the problem after it has already occurred. With new changes in food safety regulations also come new compliance challenges for the food industry. Growers, producers, harvesters and processors need to fully comprehend the rules in order to overcome the challenges associated with FSMA. The Food Safety Modernization Act will require a multitude of standards to be met and procedures to be followed in order to comply with the law, below are a few noteworthy comments to help you in your journey to FSMA compliance.

Understanding FSMA One of the first challenges that companies will face when diving into FSMA is understanding the law and the rules which will implement it. These include preventive controls specific requirements for imported foods, food safety inspections, the sanitary transportation of foods and compliance timelines. Establishing where each rule fits, and which rules apply to food facilities can be overwhelming at first. Doing a gap analysis is a good idea for this first challenge, as it will let a company know their current standing and what future steps to take. Safe Food Alliance is working to make this transition easier for the food industry by pursuing FDA-approved training on the Produce Safety and Preventive Controls Rules. This will allow Safe Food Alliance to offer public and onsite training, as well as consultation services, for companies needing guidance-look for these classes in the coming year!

What Triggered FSMA

As a result of the campaign launched in the aftermath of the PCA outbreak, President Barack Obama signed the Food Safety Modernization Act, which the FDA called the most sweeping reform in food safety laws in 70 years. "

The FDA Food Safety Modernization Act (FSMA), enables FDA to better protect public health by strengthening the food safety system. It enables the FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. A series of high profile food outbreaks generated increased consumers fear and interest, but 3 major events promoted the congress to sign FSMA into law:

1- The 2006 E.coli multistates outbreak (26 US states) linked to frozen uncooked spinach sickened 200 people (100’s were hospitalized) and led to five deaths : There was an outbreak of food-borne illness caused by Escherichia coli (E. coli) bacteria found in uncooked spinach in 26 U.S. states.

2- The 2007 melamine outbreak linked to contaminated pet food from China

3- The 2008-9 salmonella outbreak where the Peanut Corporation of America (PCA) knowingly sold tainted peanut butter which killed nine people and sickened 714 others, some critically, across 46 states. The responsible person was sentenced to life behind bars for knowingly shipping out deadly food.


The official FSPCA PCQI training course is facilitated by Dr. Faour-Klingbeil, an approved lead instructor.

FSMA Rules

Current good manufacturing practice and hazard analysis and risk-based preventive controls for food for humans
This rule applies to food facilities - registered with section 415 of the Food, Drug, & Cosmetic Act - and requires them to have a food safety plan implemented that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.

The concerned facilities are required to have and implement a written food safety plan that includes a number of points:

  • Hazard analysis: identifying any known or reasonably foreseeable biological, chemical, and physical hazards
  • Preventive controls: establishing preventive controls - such as process controls, food allergen controls, and sanitation controls - to address hazards that occur in the manufactured products
  • Oversight and management of preventive controls
  • Supply chain program: implementing a risk-based supply chain program
  • Recall plan

Standards for the growing, harvesting, packing, and holding of produce for human consumption
The Produce Safety Rule applies to covered farms and “establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.”

However, these standards don’t apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity.

Also, the main requirements involve the following:

  • Microbiological standards for agricultural water and biological soil amendments of animal origin
  • Monitoring and correction activities for domesticated and wild animals
  • Measures for preventing the contamination of sprouts
  • CGMP-like requirements for worker health and hygiene, equipment, tools, and buildings

Sanitary Transportation of Human and Animal Food
The main goal of this rule is to keep food safe from contamination during transportation by preventing issues such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

Its requirements apply to shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food. Nonetheless, these requirements don’t apply to transportation by ship or air due to limitations in the law.

On the whole, the rule establishes several requirements:

  • The design and maintenance of vehicles and transportation equipment
  • Measures taken during transportation to ensure food safety
  • Training of carrier personnel in sanitary transportation practices and documentation of the training
  • Maintenance of records of written procedures, agreements, and training

Accredited third-party certifications The rule establishes “the framework, procedures, and requirements for accreditation bodies seeking recognition by the FDA, as well as requirements for third-party certification bodies seeking accreditation.”

These entities will be able to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.

Also, the FDA published a public registry of recognized accreditation bodies on their website, as well as a list of accredited third-party certification bodies.

FSMA mentions two uses for certifications under this program:

  • To help establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP)
  • To prevent potentially harmful food from reaching U.S. consumers

Foreign Supplier Verification Program (FSVP)
The Foreign Supplier Verification Program regulation applies to importers of food (human and animal) into the United States. It requires said importers to perform certain risk-based activities to check that the food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

According to this regulation, an importer is defined as “the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.”

Moreover, importers are responsible for actions such as:

  • Determining known or reasonably foreseeable hazards with each food
  • Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
  • Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
  • Conducting supplier verification activities
  • Conducting corrective actions

Current good manufacturing practice and hazard analysis and risk-based preventive controls for food for animals
The requirements of this rule apply to animal food facilities as well, and oblige them to have a food safety plan in place as in the case of the previous rule mentioned.

Generally, domestic and foreign food facilities that are required to register with section 415 of the Food, Drug, & Cosmetic Act must comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) as well as the modernized Current Good Manufacturing Practices (CGMPs) of this rule (unless an exemption applies).

Apart from the safety plan which is similar to the food facilities producing human food, covered facilities must follow Current Good Manufacturing Practices (CGMPs) for animal food production that have been created while taking into consideration the unique aspects of the animal food industry.

Mitigation strategies to protect food against intentional adulteration
This rule is concerned with “preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.” Its requirements apply to both domestic and foreign companies that are required to register with the FDA as food facilities - the rule doesn’t, however, cover very small businesses and farms.

All the facilities covered by the rule must develop and implement a written food defense plan that includes an analysis of vulnerabilities, implementation of mitigation strategies, procedures for food defense monitoring, corrective actions, and verification.