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Food Safety Modernization Act (FSMA)

The FDA Food Safety Modernization Act (FSMA) is the most comprehensive reform of our federal food safety laws in over 70 years. The intent of the law is to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

With the release of several new rules under the Food Safety Modernization Act, it is important for Nebraska food producers, manufacturers, distributors, importers, growers and feed manufacturers to be informed of the content of the rules, and their effective dates.

The following resources are provided to assist Nebraska food businesses in understanding the FSMA rules and their application.


Links to Food Safety Modernization Act Rules:

Preventive Controls for Human Food
Certain food manufacturers and distributors in Nebraska may need to meet new regulatory requirements to prevent contamination of food.

Depending on the food and processes as well as the size of the business, food companies in Nebraska may need to comply with the Preventive Control rules starting in September of 2016.

Sanitary Transportation of Human and Animal Food
These new regulations will cover food in transit in Nebraska and nationally. Full details of this rule are available.

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
The FSVP is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier's food is not adulterated and is not misbrand with respect to allergen labeling.

Accredited Third-Party Certification
This rule establishes a voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. These requirements will help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.

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Human Foods Preventive Control Rule

The Human Food for Preventive Controls Rule sets forth new requirements and updates existing requirements for facilities that manufacture, process, pack, or hold human food.

Human Food for Preventive Controls Rule New Requirements
The new requirements include maintaining and implementing a written food safety plan that includes:

  • Hazard Analysis: The plan must identify and evaluate hazards for each type of food manufactured, processed, packed, or held at the facility.
  • 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 recall plan.
  • ** Supplier Program (NEW): The plan must establish and implement a risk-based supplier program for raw materials and ingredients for which the receiving facility identifies a significant hazard and the hazard is controlled by the supplier.
  • Monitoring Procedures: The plan must document procedures to ascertain that preventive controls are consistently performed.
  • Corrective Actions: The plan must identify steps to take if preventive controls are not adequately implemented, to minimize the likelihood of problems reoccurring, to evaluate the food for safety, and to block problem food from entering commerce.
  • Verification: The plan must spell out verification activities and document that preventive controls are effective and consistently implemented.
  • ** Verification of Implementation and Effectiveness (NEW): Verification measures must include product testing and environmental monitoring, as appropriate to the facility, the food, and the nature of the preventive control.

A facility is required to maintain a written food safety plan and to keep records of each element of the plan. The rule adds a supplier approval and verification program, as well as environmental monitoring and product testing, to the requirements of the food safety plan. Only an individual qualified either through training or experience can write the facility’s food safety plan. Food safety plans would be reassessed every three years, or more frequently if there are problems.

Updated GMP Requirements
The Preventive Control Rule also updates Current Good Manufacturing Practice (cGMP) requirements. Updates include clarifications on protections against cross-contact of food by allergens, language changes, and deletion of certain provisions containing recommendations. Facilities that are exempt or subject to modified requirements in the new requirements for hazard analysis and preventive controls would generally be subject to cGMP requirements.

At A Glance: For a quick overview of the Human Food Preventive Control Rule requirements click on the link below:
Human Food PC Rule ‘at a Glance’

Training: For more information on Human Food Preventive Control Qualified Individual (PCQI) Training, when the next class will be or to register for such a class visit the website below:
Human Foods Preventive Controls Alliance - Training & Resource

Records: For additional information on what records and/or how to write a food safety plan to satisfy the rule’s record requirement visit the following page:
Human Foods Food Safety Plan Template

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Hazard Analysis & Critical Control Point

HACCP is a preventive system of hazard control rather than a reactive one. Food Processors can use it to ensure safer food products for consumers. To ensure safer food, the HACCP system is designed to identify hazards, establish controls and monitor these controls. Hazards can be harmful microorganisms or chemical and/or physical contaminants.

HACCP

External Links to HACCP Information

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Resources for Food Manufacturers

FDA TAN (Technical Assistance Network)
The FDA TAN will track and address questions on the Food Safety Modernization Act (FSMA). The network is available to industry, regulators, academia, consumers and others with questions.

FDA FSMA Fact Sheets and Presentations
Find FDA presentations and webinars on the final rules for preventive controls for human and animal food. Find out who’s covered, the definition of a farm, information on significant provisions and more.

FDA FSMA Fact Sheet & Final Rule for Preventive Controls for Human Food
The FDA Preventive Control for Human Food Rule is now final and compliance dates for some businesses begin in September 2016.

FDA FSMA Proposed Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Human & Animals

General FSMA Information
FSMA Fact Sheets and Presentations
FSMA FAQs
FSMA Technical Assistance

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