The Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) is the first major expansion of federal food safety laws since 1938. FSMA expands the Food and Drug Administration (FDA) powers broadly and establishes relationships between FDA, USDA, the CDC and DHS in order to more effectively and proactively prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods.

FSMA does not change food safety regulations for meat, poultry, and egg products, which remain under the U.S. Department of Agriculture’s jurisdiction. The new rules were designed to prevent breakdowns at any point in the food supply chain in order to minimize the chances of health issues and/or disruption and economic loss to the food industry.

FSMA authorizes new regulations for farmers, food processes and producers and food importers. The Act includes five (5) new rules:


Notable points of the legislation include:

  • Risk-based inspection of food processing facilities
  • Import control, via the Foreign Supplier Verification Program (FSVP)
    • Monitoring records for shipments
    • Lot-by-lot certification of compliance
    • Annual on-site inspections (using 3rd party auditors to inspect on FDA’s behalf)
    • Checking hazard analysis and risk-based preventive control plan of foreign supplier
    • Periodic testing and sampling shipments
    • and the Voluntary Qualified Importer Program (VQIP)
      • Prior notice of imported food shipments
      • Inspection of foreign food facilities
      • Authority to require import certification for high-risk foods;
      • FDA to establish Foreign Offices to provide assistance on food safety measures
    • Prohibition of product from facilities or countries that refuse US inspection
    • Laboratory accreditation for analysis of foods
    • Enhanced tracking of food shipments
    • Enhanced record keeping
    • Foodborne illness surveillance systems
    • FDA Authority to require mandatory recalls
    • Strengthening of existing collaboration among all food safety agencies whether they are Federal, state, local, territorial, tribal, or foreign
    • Provision of Federal funding for:
      • Improvement of training for state, local, territorial and tribal food safety officials
      • Inspection resources, establishment of labs and food safety programs
    • Establishment of programs to accredit 3rd party inspection resources to prevent capacity deficits

The first two (2) rules are in the rulemaking stage, FDA has released their proposed (draft) regulations for public comment.  Once the public comments have been received and reviewed, the agency will publish final rules, but for the purposes of this blog, we will report the draft version of the rules.


Highlights of the Draft Produce Rule


The proposed Produce Rule sets forth new standards for growing, harvesting, packing, and holding of produce for human consumption. The standards apply to fruits and vegetables normally consumed raw, such as apples, carrots, lettuce, onions, and tomatoes. The proposed Produce Rule does not apply to produce rarely consumed raw (such as winter squash) or produce grown for personal consumption.

The proposed Produce Rule establishes standards for:

  • Agricultural Water: Farmers must ensure that water that is intended or likely to contact produce or food-contact surfaces is safe and of adequate sanitary quality, with inspection and periodic testing requirements.
  • Biological Soil Amendments of Animal Origin: Specifies types of treatment, methods of application, and time intervals between application of soil treatments and crop harvest (treatments include manure and composted manure.
  • Health and Hygiene: Farm personnel must follow defined hygienic practices, including hand washing, not working when sick, and maintaining personal cleanliness.
  • Domesticated and Wild Animals: With respect to domesticated animals, the proposed rule would require certain measures, such as waiting periods between grazing and crop harvest, if there is a reasonable probability of contamination. With respect to wild animals, farmers must monitor for wildlife intrusion and not harvest produce visibly contaminated with animal feces.
  • Equipment, tools, and buildings: Imposes requirements for equipment and tools that come into contact with produce, as well as for buildings and other facilities.
  • Training: Requirements for training of supervisors and farm personnel who handle produce covered by the rule.
  • Sprouts: Establishes separate standards for sprout production, including treatment of seed before sprouting and testing of spent irrigation water for pathogens.

Accompanying these industry specific standards, the rule imposes documentation requirements and standards in order to produce verifiable documentation proving that all other requirements were met.


Highlights of the Draft Preventative Controls Rule


The proposed Preventative Controls Rule sets forth new standards for facilities that manufacture, process, pack, or hold human food.

Note: Several on-farm activities may classify a farm as a “facility” subject to the Preventive Controls rule.  Farms identified as facilities must also register with FDA.

The proposed Preventive Controls rule has two (2) fundamental objectives:

  1. Setting new requirements for hazard analysis and risk-based preventive controls, and
  2. Enacting revisions to existing Current Good Manufacturing Practice (cGMP) requirements that apply to food processing facilities


New Requirements:

The new requirements include maintaining and implementing a written food safety plan, designed and written by a qualified resource that is scheduled for regular and routine re-assessment.  The Plan should be considered a guidebook to the facility wide quality program, and must address:

  • Hazard Analysis: The plan must identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility. Hazard Analysis programs must be internally assessed for effectiveness every three (3) and must address:
    • biological, chemical, physical, radiological hazards; natural toxins; pesticide and drug residues; unapproved food/color additives; allergens
    • hazards naturally occurring or intentionally introduced
  • Preventive Controls: The plan must identify preventive controls that significantly minimize or prevent hazards. Preventive controls include process controls, food allergen controls, sanitation controls, and a product recall plan.
  • Monitoring Procedures: The plan must document procedures established to demonstrate that that preventive controls are in place and effective.
  • Corrective Actions: The plan must identify steps to take if the preventive controls either identify an issue or fail to prevent an issue.  The steps must be designed to quickly evaluate the impact (scope of the issue), prevent any contaminated product from entering the market place, and to prevent recurrence of the problem.
  • Verification: The plan must specify verification activities designed to verify products released to the market place are issue free.


Revised Requirements

The proposed Preventive Control Rule also updates Current Good Manufacturing Practice (GMP) requirements. Revisions include clarifications on protections against cross-contact of food by allergens, language changes, and deletion of certain provisions containing recommendations.

Note: Facilities that are exempt or subject to modified requirements in the new requirements for hazard analysis and preventive controls would generally still be subject to cGMP requirements.


Want to Learn More?

The following is a graphic demonstrating the breakdown of roles and responsibilities assigned to the implementation team.

FSMA Roles and Responsibilities Chart

The detailed draft rules includes implementation deadlines, dates and all applicable fees.

For any of our readers who wish to review the draft regulations in detail, visit:

Watch for FSMA MSFC 104 open docket announcement – Subscription feature available.  Public and industry questions can be sent directly to:  [email protected]


© Coda Corp USA 2014. All rights reserved.

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Authored By:

Gina Guido-Redden

Chief Operating Officer


Coda Corp USA


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“Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives.”


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