GFSI – Global Food Safety Initiative
Global Food Safety Initiative – The Global Food Safety Initiative (GFSI) is a private organization, established and managed by the international trade association, the Consumer Goods Forum under Belgian law in May 2000. The GFSI maintains a scheme to benchmark food safety standards for manufacturers as well as farm assurance standards.
Due to complex challenges in today’s food supply chain, many of the world’s largest food retailers are mandating supplier certification to Global Food Safety Initiative (GFSI) schemes, which include SQF, BRC, IFS, FSSC, GLOBALG.A.P. and BAP and CanadaGAP.
There are 3 GFSI Standards prevalent in the USA SQF ( Most Popular) BRC ( 2 versions one for Distributors & One for manufacturers)
BRC – British Retail Consortium- GFSI Standard
The BRC Global Standard for Food Safety is developed by food industry experts from retailers, manufacturers and food service organizations to ensure it is rigorous and detailed, yet easy to understand.
First published in 1998, the Standard is now in its seventh issue and is well-established globally. It has evolved with input from many leading global specifiers.
It provides a framework to manage product safety, integrity, legality and quality, and the operational controls for these criteria in the food and food ingredient manufacturing, processing and packing industry.
BRC is a GFSI Standard – There are 2 versions of the Standard including one for Manufacturers and one for distributors.
SQF – Safe Quality Food – GFSI Standard
SQF certification tells the world that your Quality Management System (QMS) conforms to food safety regulations, that your organization is committed to continuous improvement of your QMS, and that your organization is a practitioner of good agricultural practices (GAPs) and good manufacturing principals (GMPs) for food.
SQF is a Global Food Safety Initiative (GFSI) benchmarked standard, which means that it is recognized world-wide as a reputable food safety certification scheme.
First is a common system element module that is required of all organizations seeking SQF certification. There are three levels of the system elements to choose from, allowing organizations greater flexibility on how they choose to implement a food safety QMS:
Level 1: Fundamental food safety controls appropriate for low-risk products.
Level 2: HACCP and ISO based food safety program recognized by GFSI.
Level 3: A comprehensive masters of safe and quality management systems. Requirements at this level exceed GFSI standards guidance.
Next are numerous sector-specific modules. This provides organizations the opportunity to address specific GMP, GAP and HACCP requirements of their business sector, and also allows even small companies to attain SQF certification.
Current food good manufacturing practices (cGMPs) are published in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110). cGMPs describe the methods, equipment, facilities, and controls for producing processed food. As the minimum sanitary and processing requirements for producing safe and wholesome food, they are an important part of regulatory control over the safety of the nation’s food supply. cGMPs also serve as one basis for FDA inspections.
FSMA – Food Safety Modernization Act of 2011
There are 7 Rules
- Rule 1: Preventive Controls for Human Food (PCQI)
- Rule 2: Preventive Controls for Animal Food
- Rule 3: Produce Safety Rule
- Rule 4: Foreign Supplier Verification Program (FSVP)
- Rule 5: Accredited Third Party Certification
- Rule 6: Sanitary Transport for Human & Animal Food
- Rule 7: Mitigation Strategies to Protect Food Against Intentional Adulteration
Rule 1: Preventive Controls for Human Food (PCQI is required)
Covered facilities are required to implement a food safety plan that includes a hazard analysis and risk-based preventive controls to minimize or prevent the identified hazards. Safety requirements are established for facilities that process, package or store human food.
The core preventative controls are
- Food Allergen Preventive Controls
- Sanitation Preventive Controls
- Supply Chain Preventive Controls
- Recalls The plan must be written by a PCQI.
Rule 2: Preventive Controls for Animal Food ( PCQI is required)
The rule requires animal food facilities to enact a safety plan that includes an analysis of hazards, which aims to protect animal food and feed from contamination.
- By products of human food sold as animal feed.
- The plan must be written by a PCQI.
Rule 3: Produce Safety Rule
Sets science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Focuses on conditions and practices identified as potential contributing factors for microbial contamination.
- Agricultural water (water testing, no detectable generic E. Coli)
- Biological soil amendments of animal origin
a. Manure – time between application and harvesting
b. Stabilized compost – standard for microbiological contamination such as listeria and salmonella.
- Worker health and hygiene (hygiene training, use of hygienic practices, ill people must stay away from working at products.
- Equipment, tools, buildings and sanitation (appropriate storage, maintenance, cleaning and sanitation)
- Domesticated and wild animals (examination fo the growing areas for contamination by animals)
- Growing, harvesting, packing and holding activities
- Sprouts requirements (prevention of contamination, listeria testing)
Rule 4: Foreign Supplier Verification Program (FSVP)
Importers must perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets U.S. FDA Food Safety standards.
Rule 5: Accredited Third Party Certification
Establishes program for the accreditation of third-party certification to conduct food safety audits and issue certifications of foreign facilities and the foods they produce.
Foreign entities may use certifications for two purposes
- Certifications may be used by importers to participate in the Voluntary Qualified Importer Program (VQIP) and to expedite review and entry of food.
- To prevent potentially harmful food from reaching U.S. consumers, Note: FDA can also require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.
Rule 6: Sanitary Transport for Human & Animal Food
The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitation practices to ensure food safety. The rule does not apply to transportation by air or by ship due to law limitations.
- Vehicles and Transportation Equipment – Must be maintained, cleanable and designed for their intended purpose and capable to main temperatures necessary for safe transport.
- Transportation Operations – Protections from the unintended incorporation of food allergens.
Adequate temperature control during transport.
Protection of foods from cross contamination( ready to eat foods contacting raw food)
Protection of food from non-food items in the same or previous load.
- Training – Documented training of carrier personnel in sanitary transportation practices if carrier is responsible for sanitary conditions during transport.
- Records – Maintenance of written procedures, agreements and training records. Retention time depends of the type of record but not needed to exceed 12 months.
Rule 7: Mitigation Strategies to Protect Food Against Intentional Adulteration
Aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health.
Intention and Content
Each covered facility is required to prepare and implement a food defense plan for the identification of vulnerabilities, mitigation strategies and procedures for food defense.
For each point, step or procedure in the facility’s process, these elements must be evaluated:
- The severity and scale of the potential impact on public health.
- The degree of physical access to the product.
- The ability to successfully contaminate the product.
Actions necessary to address and mitigate the vulnerabilities.
Mitigation Strategy Management Components
Steps taken to ensure the proper implementation of each mitigation strategy.
PCQI – Preventive Controls Qualified Individual
Required Under FSMA Rule 1 & 2 – Every Human & Animal Food Manufacturing Company must have 1 PCQI on their Payroll or must have a 3rd party serve as their PCQI. If it is a third party PCQI they must be able to respond to their facility in 24 hours. The PCQI’s the official in charge of authoring a company’s Food Safety Plan.
HACCP – Hazard Analysis Critical Control Point
Hazard analysis and critical control point.
Food production, storage, and distribution monitoring system for identification and control of associated health hazards. It is aimed at prevention of contamination, instead of end-product evaluation. In place of relying on food inspectors to detect food safety problems, HACCP shifts the responsibility to the food producer to ensure that the product is safely consumable. Proposed by the Codex Alimentarius Commission for the food industry in general, and meat, poultry, and seafood industry in particular, it has been adopted by some 150 countries.
They are: (1) Identify the potential consumer health hazards, (2) Identify the control points where the identified hazards may occur, (3) Establish critical limits for the potential hazards and safety measures, (4) Establish monitoring routines to ensure safety measures are working, (5) Establish appropriate responses if monitoring indicates a problem, (6) Establish accurate and detailed record keeping system that documents problems and the remedial steps to be taken, and (7) Establish a verification system that ensures the above steps are being followed.
Food Defense is the effort to protect food from acts of intentional adulteration. In May 2016 FDA issued the final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration with requirements for covered facilities to prepare and implement food defense plans.
A food recall is a voluntary action by a manufacturer or distributor to protect the public from products that may cause health problems or possible death. A recall is intended to remove food products from commerce when there is reason to believe the products may be adulterated or misbranded.
A food sanitation plan is a set of written cleaning procedures that lay out what is to be cleaned, when it is to be cleaned, who is to clean it, and with what it is to be cleaned with. The Sanitation Plan helps to ensure the safe and sanitary operation of your food premises through clearly laid out instructions and continued monitoring. Under the Food Premises Regulation, every operator of a food service establishment or food premises where carcasses are handled or where food is processed or prepared must develop, maintain, and follow written procedures to ensure the safe and sanitary operation of the establishment. This includes having written procedures for the cleaning and sanitizing of the establishment itself, as well as all the equipment and utensils used in the establishment. The written procedures must also identify the cleaning and sanitizing agents used in the establishment, including their concentrations and their prescribed uses.
FSPCA – Food Safety Preventative Controls Alliance
FSPCA was established in 2011 as part of a grant from the FDA when the FSMA was signed. FSPCA Supports food safety production by conducting trainings, develop core curriculums and supporting outreach programs and technical assistance networks to help the food industry comply with preventative controls measures. Created the FDA recognized “standard curriculum” for Preventive Controls for Human Food” as well as training courses designed to cover the 7 rules issued under FSMA.
PSA – Produce Safety Alliance
The Produce Safety Alliance is a collaborative effort between the FDA, USDA and Cornell University in preparing fresh produce growers to meet regulatory requirements issued by the FSMA Produce Safety Rule.
SSA – Sprout Safety Alliance
The Sprout Safety Alliance was created in 2012 by the FDA in conjunction with the Illinois Institute of Technology’s Institute for Food Safety and Health. The SSA developed a core curriculum and training to improve the industries understanding and implementation of best practices to improve sprout safety among the sprout production community.
Environmental Monitoring Program
An environmental monitoring program assesses the overall efficiency of hygienic practices within a facility and provides invaluable information to prevent microbial contamination of food products. The program acts as an early warning system for microbiological hazards in both the production and post-production environment.