Comparing FSSC 22000 against FSMA Preventive Controls Rules

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates (See Appendix 4) for some businesses begin in September 2016. Key Requirements include:

 

1. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan that includes:

• Hazard analysis
• Preventive controls
• Monitoring
• Corrective actions and corrections
• Verification

2. The definition of a ‘farm’ is clarified to cover two types of farm operations. Operations defined as farms are not subject to the preventive controls rule.

• Primary Production Farm
• Secondary Activities Farm

3. Supply-chain program is more flexible, with separate compliance dates established. The rule mandates that a manufacturing/processing facility have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control.

 

4. Current Good Manufacturing Practices (CGMPs) are updated and clarified. Management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties.

 

Such employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.

 

Note that there are similar requirements related to preventive controls.

 

The FDA’s longstanding position that CGMPs address allergen cross-contact is now explicit in the regulatory text.

 

The FSSC 22000 Food Safety System Certification scheme was first published in 2009 and is one of the main certification schemes recognized by the Global Food Safety Initiative (GFSI). 12.000+ organizations in over 140 countries have now achieved FSSC 22000 certification*. Certification to the scheme is widely recognized and provides assurance that an organization has implemented a robust food safety management system.

 

* Source www.fssc22000.com

 

The FSSC 22000 Certification scheme for food manufacturers is based on:

• ISO 22000 Food safety management systems - Requirements for any organization in the food chain
• ISO Technical Specification 22002-1 - Prerequisite programmes on food safety Part 1: Food manufacturing
• FSSC 22000 Additional Requirements (See Appendix 3)

ISO 22000 stipulates the food safety management system requirements of the scheme and covers key elements of food safety management including; Documentation Control, Management Responsibility, Food Safety Policy, FSQMS Planning, Communication, Resource Management, Traceability, Corrections/Corrective Actions, Handling of Potentially unsafe products/Withdrawals, Monitoring and Measuring, Validation and Verification, Internal audits, Management Review and Improvement (see Appendix 1 for a full list of sections).

 

The FSSC 22000 Certification scheme prerequisite programme requirements are stipulated in a combination of ISO 22000 and ISO 22002. Prerequisites are described in ISO 22000 Clause 7.2.3:

 

When selecting and/or establishing PRP(s), the organization shall consider and utilize appropriate information [e.g. statutory and regulatory requirements, customer requirements, recognized guidelines, Codex Alimentarius Commission (Codex) principles and codes of practices, national, international or sector standards]. NOTE Annex C gives a list of relevant Codex publications.

 

The organization shall consider the following when establishing these programmes:

 

a) construction and lay-out of buildings and associated utilities
b) lay-out of premises, including workspace and employee facilities
c) supplies of air, water, energy and other utilities
d) supporting services, including waste and sewage disposal
e) the suitability of equipment and its accessibility
f) management of purchased materials, supplies, disposals and handling of products
g) measures for the prevention of cross contamination
h) cleaning and sanitizing
i) pest control
j) personnel hygiene
k) other aspects as appropriate

 

TECHNICAL SPECIFICATION ISO/TS 22002-1 Prerequisite programmes on food safety — Part 1: Food manufacturing elaborates on requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3 in sections 4 – 13 (See Appendix 2 for a full list of sections). In addition the technical specification adds other aspects which are considered relevant to manufacturing operations in the following sections:

• 14 Rework
• 15 Product recall procedures
• 16 Warehousing
• 17 Product information/consumer awareness
• 18 Food defence, biovigilance and bioterrorism

One of the key differences with the FSSC 22000 certification scheme compared to other GFSI benchmarked standards is the requirement for operational prerequisite programmes. When you come to Clause 7.4.3 Hazard assessment onwards you need to decide if control measures for a hazard fall into the category of needing to be controlled through operational PRP(s) or by the HACCP plan.

 

Clause 7.4.3 Hazard assessment requires the identification of food safety hazards whose elimination or reduction to acceptable levels is essential to the production of a safe food. Clause 7.4.4 Selection and assessment of control measures requires that the control measures selected to control these hazards are categorized as to whether they need to be managed through operational PRP(s) or by the HACCP plan. There is a requirement that the selection and categorization of control measures is carried out using a logical approach that includes assessments of the effect of the control measure on identified food safety hazards, any synergistic effects between control measures, the feasibility for monitoring, the likelihood and severity of the consequences of failure of a control measure and whether the control measure is specifically established and applied to eliminate or significantly reduce the level of hazard(s). Clause 8.2 Validation of control measure combinations requires that control measures to be included in operational PRP(s) and the HACCP plan are subject to validation.

 

FSSC 22000 aligns with Preventive Controls for Human Food (Final Rule)

 

A recent comparison of FSSC 22000 against the FSMA Final Preventive Controls (PC) Rule for Human Food was commissioned by The Foundation FSSC 22000 and conducted by The Acheson Group (TAG), an independent consultancy with expertise in food safety legislation. Although it was intended as a gap analysis, the comparison showed that there are no gaps in the elements required for FSSC 22000 certification when compared with the requirements of the final PC rule.

 

Source: FSSC 22000

 

Comparison of FSSC 22000 against the Preventive Controls for Human Food (Final Rule) The Acheson Group

 

Full details of the Acheson Group report can be found at the link above. Extracts and a comparison table from the report:

 

Summary: FSSC 22000 as the owner of a GFSI recognized scheme should be very proud of how it compares with the FSMA Preventive Controls (PC) final rule in several areas.Source: http://www.fssc22000...-april-2016.pdf

 

Conclusion: Based on this analysis, a facility that has achieved FSSC 22000 certification is in an excellent place with regard to compliance with the FDA PC rules.

 

Appendix 1

 

ISO 22000 Food safety management systems - Requirements for any organization in the food chain – Sections:

 

4. Food Safety Management System
4.1 General Requirements
4.2 Documentation
4.2.2 Document Control
4.2.2 Document Control
4.2.3 Record Control
5. Management Responsibility
5.1 Management Commitment
5.2 Food Safety Policy
5.3 FSQMS Planning
5.4 Responsibility & Authority
5.5 Food Safety Team Leader
5.6 Communication
5.6.1 External Communication
5.6.2 Internal Communication
5.7 Contingency preparedness and response
5.8 Management Review
6. Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.2 Competence, Awareness and Training
6.3 Infrastructure
6.4 Work Environment
7. Planning and Realisation of Safe Products
7.1 General Planning and Realisation of Safe Products
7.2 Prerequisite Programmes
7.3 Preliminary steps to enable Hazard analysis
7.4 Hazard Analysis
7.5 Operational Control
7.5 Establishing the Operational Pre-requisites
7.6 Establishing the HACCP plan
7.7 Updating of preliminary information and documents specifying the PRP(s) and HACCP plan
7.8 Verification Planning
7.9 Traceability System
7.10.1 Corrections
7.10.2 Corrective Actions
7.10.3 Handling of Potentially unsafe products
7.10.4 Withdrawals
8. Validation, Verification and Improvement of the FSMS
8.1 General
8.2 Validation of Control Measure Combinations
8.3 Control of Monitoring and Measuring
8.4 FSQMS Verification
8.4.1 Internal audits
8.4.2 Evaluation of Individual Verification results
8.4.3 Analysis of results of Verification activities
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 FSQMS updating

 

Appendix 2

 

TECHNICAL SPECIFICATION ISO/TS 22002-1 First edition 2009 Prerequisite programmes on food safety — Part 1: Food manufacturing Sections:
4 Construction and layout of buildings
5 Layout of premises and workspace
6 Utilities – air, water, energy
7 Waste disposal
8 Equipment suitability, cleaning and maintenance
9 Management of purchased materials
10 Measures for prevention of cross contamination
11 Cleaning and sanitizing
12 Pest control
13 Personnel hygiene and employee facilities
14 Rework
15 Product recall procedures
16 Warehousing
17 Product information/consumer awareness
18 Food defence, biovigilance and bioterrorism

 

Appendix 3
FSSC 22000 Certification Scheme Part I REQUIREMENTS FOR ORGANIZATIONS THAT REQUIRE CERTIFICATION
Appendix I A
ADDITIONAL REQUIREMENTS
1. Specifications for services
2. Supervision of personnel in application of food safety principles
3. Specific regulatory requirements
4. Announced, but unscheduled audits of certified organizations
5. Management of Inputs
6. Management of natural resources such as water and soil regarding animal production
7. Food defence, bio vigilance and bioterrorism (extension to animal production)

 

FSSC 22000 guidance on Appendix IA
Provides additional information relating to questions arising from the revised requirements

 

Appendix 4

 

FSMA Compliance Dates

 

Compliance dates for businesses are staggered over several years after publication of the final rule.

• Very small businesses (averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): Three years, except for records to support its status as a very small business (January 1, 2016).
• Businesses subject to the Pasteurized Milk Ordinance (compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule): Three years
• Small businesses (a business with fewer than 500 full-time equivalent employees): Two years
• All other businesses: One year

Compliance dates after publication of the final rule for the requirements of the supply chain program:

• Receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: Two years
• Receiving facility is a small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Two years or six months after the supplier is required to comply with the applicable rule, whichever is later
• Receiving facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: 18 months
• Receiving facility is not a small or very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Six months after the supplier is required to comply with the applicable rule

 

Author Biography
Tony Connor, Chief Technical Advisor, IFSQN

 

Tony received an honors degree in Molecular Biology and Biochemistry from Durham University before embarking on a successful 20-year career in the UK food industry in a variety of roles including Laboratory Manager, Production Manager, Quality Assurance Manager, Technical Manager, Technical Development Manager and Group Technical Manager. Tony qualified as a Lead Audit Assessor in 1994. Since 2009 Tony has been Chief Technical Advisor to the International Food Safety & Quality Network.

 

FSSC 22000 Implementation Package

 

IFSQN offer a comprehensive documentation package suitable for Food Manufacturers looking to achieve certification to the FSSC 22000 scheme for Food Safety Management Systems. All document templates are fully editable to suit your process and are provided by download in standard Microsoft Office formats. Find Out More >>