Prerequisite Programs as a Basis for Ensuring Food Safety · as a Basis for Ensuring Food Safety ... SEAFOOD HACCP 1. SSOP 2. GMP’s 3. ... International Standards Organization

Prerequisite Programs Prerequisite Programs as a Basis for Ensuring as a Basis for Ensuring

Food SafetyFood Safety

Richard F. StierRichard F. StierConsulting Food ScientistsConsulting Food ScientistsSonoma, CA 95476, USASonoma, CA 95476, USA

[email protected]@aol.com

mailto:[email protected]

FOOD SAFETY PYRAMIDFOOD SAFETY PYRAMID

PRODUCT IDENTIFICATION,RECALLS, EDUCATION

GMPs

HACCP

SAFE FOOD

SANITATION

Prerequisite programs are the foundation upon which food safety programs are built. Without good prerequisite programs, your food safety programs may teeter and fall

PREREQUISITESPREREQUISITES If you do not have If you do not have

prerequisite programs prerequisite programs in place, go no furtherin place, go no further

You cannot implement You cannot implement HACCP properlyHACCP properly

HISTORY OF PREREQUISITESHISTORY OF PREREQUISITES

HACCP plans developed in the 1980’s and HACCP plans developed in the 1980’s and early 1990’s had lots of CCP’s; often over early 1990’s had lots of CCP’s; often over 2020

HACCP plans incorporated issues such as HACCP plans incorporated issues such as cleaning, coding and general sanitationcleaning, coding and general sanitation

Since the HACCP is based on “Since the HACCP is based on “process process controlcontrol,” CCP’s like this were hard to ,” CCP’s like this were hard to monitor and even harder to validate, i.e., monitor and even harder to validate, i.e., handwashing, cleaninghandwashing, cleaning

PREREQUISITE PROGRAMSPREREQUISITE PROGRAMS

Food safety professionals realized that Food safety professionals realized that HACCP plans with so many CCP’s were HACCP plans with so many CCP’s were unwieldy and difficult to manage, and unwieldy and difficult to manage, and prone to failureprone to failure

Simplify the processSimplify the process Prerequisites programs in lieu of CCP’s.Prerequisites programs in lieu of CCP’s. The United States Seafood HACCP The United States Seafood HACCP

Regulation found in 21 CFR Part 123 Regulation found in 21 CFR Part 123 introduced this concept from a regulatory introduced this concept from a regulatory standpointstandpoint

SANITATION - WHY????SANITATION - WHY????

“… “…It has not yet succeeded in developing It has not yet succeeded in developing a culture throughout the seafood industry a culture throughout the seafood industry in which processors assume an operative in which processors assume an operative role in controlling sanitation in their plants.”role in controlling sanitation in their plants.”

Preamble to Seafood HACCP RegulationPreamble to Seafood HACCP Regulation

SEAFOOD HACCP - 123.11SEAFOOD HACCP - 123.11 (a) (a)Each processor should have a written Each processor should have a written standard operating procedure (herein standard operating procedure (herein referred to as SSOP) or similar referred to as SSOP) or similar document that is specific to each document that is specific to each location where fish and fishery products location where fish and fishery products are produced. The SSOP should are produced. The SSOP should specify how the processor will meet specify how the processor will meet those sanitary conditions and practices those sanitary conditions and practices which are monitored according to which are monitored according to paragraph (b) of this section.paragraph (b) of this section.

SEAFOOD HACCP - 123.11 (b)SEAFOOD HACCP - 123.11 (b)Each processor shall monitor the Each processor shall monitor the conditions and practices during processing conditions and practices during processing with sufficient frequency to ensure, at a with sufficient frequency to ensure, at a minimum, conformance with those minimum, conformance with those conditions specified in Part 110 of this conditions specified in Part 110 of this chapter…...chapter…...

So, the regulation directly references the So, the regulation directly references the current Good Manufacturing Practicescurrent Good Manufacturing Practices

SEAFOOD HACCPSEAFOOD HACCP 1.1. SSOPSSOP2.2. GMP’sGMP’s3.3. Product IdentificationProduct Identification4.4. Traceability & RecallsTraceability & Recalls5.5. Preventive MaintenancePreventive Maintenance6.6. Education/TrainingEducation/Training

SPECIFIC REQUIREMENTSSPECIFIC REQUIREMENTS Safety of waterSafety of water Condition & cleanliness of food contact surfacesCondition & cleanliness of food contact surfaces Prevention of cross-contaminationPrevention of cross-contamination Handwashing, hand sanitizing & toiletsHandwashing, hand sanitizing & toilets Protection from adulterationProtection from adulteration Proper storage & use of toxic compoundsProper storage & use of toxic compounds Employee healthEmployee health Pest controlPest control

SANITATION SSOP’SSANITATION SSOP’SUSDA SANITATION REGULATION – USDA SANITATION REGULATION –

GENERAL RULES 416.11GENERAL RULES 416.11 Each official establishment shall develop, Each official establishment shall develop, implement, and maintain written standard implement, and maintain written standard operating procedures for sanitation operating procedures for sanitation (Sanitation SOP’s) in accordance with (Sanitation SOP’s) in accordance with the requirements of this part.the requirements of this part.


Development of Sanitation SOP’s 416.12Development of Sanitation SOP’s 416.12

(a) The Sanitation SOP’s shall describe all procedures an official establishment will conduct daily, before and during operations, sufficient to prevent direct contamination or adulteration of product(s).


Development of Sanitation SOP’s Development of Sanitation SOP’s 416.12416.12(b) The Sanitation SOP’s shall be signed and

dated by the individual with overall authority on-site or a higher level official of the establishment. This signature shall signify that the establishment will implement the Sanitation SOP’s as specified and will maintain the Sanitation SOP’s in accordance with the requirements of this part. The Sanitation SOP’s shall be signed and dated upon initially implementing the Sanitation SOP’s and upon any modification to the Sanitation SOP’s.


Development of Sanitation SOP’s Development of Sanitation SOP’s 416.12416.12

(c ) Procedures in the Sanitation SOP’s that are to be conducted prior to operations shall be identified as such, and shall address, at a minimum, the cleaning of food contact surfaces of facilities, equipment, and utensils.

(d) The Sanitation SOP’s shall specify the frequency with which each procedure in the Sanitation SOP’s is to be conducted and identify the establishment employee(s) responsible for the implementation and maintenance of such procedure(s).


Implementation of SOP’s Implementation of SOP’s 416.13416.13

(a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

(b) Each official establishment shall conduct all other procedures in the Sanitation SOP’s at the frequencies specified.

(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.


Maintenance of SOP’s Maintenance of SOP’s 416.14416.14

Each official establishment shall routinely evaluate the effectiveness of the Sanitation SOP’s and the procedures therein in preventing direct contamination or adulteration of product(s) and shall revise both as necessary to keep them effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel.

SANITATION SSOP’SSANITATION SSOP’SUSDA SANITATION REGULATIONUSDA SANITATION REGULATION

416.15 Corrective Actions. 416.16 Recordkeeping requirements. 416.17 Agency verification.

The sanitation regulation immediately precedes the HACCP Regulation found in 9 CFR Part 417

INTERNATIONAL HARMONIZATIONINTERNATIONAL HARMONIZATION& PREREQUISITE PROGRAMS& PREREQUISITE PROGRAMS

HACCP throughout the HACCP throughout the worldworld

Codex AlimentariusCodex Alimentarius International regulatory International regulatory

focus on safetyfocus on safety ISO 22000 - 2005ISO 22000 - 2005

MANDATORY HACCP FOR MANDATORY HACCP FOR FOOD PROCESSORSFOOD PROCESSORS

European UnionEuropean Union China for all export productsChina for all export products Australia and New ZealandAustralia and New Zealand Many othersMany others

Prerequisite programs are part of the Prerequisite programs are part of the equation….equation….

CODEX ALIMENTARIUSCODEX ALIMENTARIUS Basic Texts of Food HygieneBasic Texts of Food Hygiene Enacted June 1997Enacted June 1997 Agreement amongst members of the Agreement amongst members of the

Codex Committee on Food Hygiene Codex Committee on Food Hygiene (CCFH) was unique. This guideline (CCFH) was unique. This guideline literally “flew” through the approval literally “flew” through the approval process.process.

But remember, Codex is not a STANDARD, But remember, Codex is not a STANDARD, it is a guidance document.it is a guidance document.

CODEX ALIMENTARIUSCODEX ALIMENTARIUS GUIDELINES FOR THE APPLICATION

OF THE HACCP SYSTEM Prior to application of HACCP to any sector of the food

chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system. During hazard identification, evaluation, and subsequent operations in designing and applying HACCP systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety.

CODEX ALIMENTARIUSCODEX ALIMENTARIUS Codex General Principles of Food HygieneCodex General Principles of Food Hygiene

Environmental hygieneEnvironmental hygiene Hygienic productionHygienic production Sanitary design of equipment & facilitiesSanitary design of equipment & facilities Recall programsRecall programs Maintenance & cleaningMaintenance & cleaning Pest managementPest management Waste managementWaste management Water quality and safetyWater quality and safety Personal HygienePersonal Hygiene TrainingTraining

CODEX ALIMENTARIUSCODEX ALIMENTARIUS Codex is a guidance documentCodex is a guidance document The document uses the word “The document uses the word “shouldshould” ”

throughoutthroughout Has served as the model for food quality Has served as the model for food quality

and safety programs/standards and safety programs/standards throughout the worldthroughout the world British Retail Consortium (BRC)British Retail Consortium (BRC) Global Food Safety NetworkGlobal Food Safety Network

CODEX ALIMENTARIUSCODEX ALIMENTARIUSo The application of HACCP is compatible with the

implementation of quality management systems, such as the ISO 9000 series, and is the system of choice in the management of food safety within such systems.

o This statement has contributed to many groups “certifying” HACCP programs, even though there was no internationally recognized Food Safety Management Standard, i.e., through ISO or the International Standards Organization.

ISO ISO Now there is a food safety management system ISO 2200 – September 1, 2005 Food Safety Management Systems:

Requirements for any organization in the food chain

This is a new standard that has been many years in the making. The committee, TC-34, was hosted by the Danish Institute of Standard in Charlottenlund, Denmark

Dr. Surak, Steve Wilson and Richard Stier represented the United States on this committee.

PREREQUISITE PROGRAMS & ISOPREREQUISITE PROGRAMS & ISO

Major topic of discussion on this subjectMajor topic of discussion on this subject The term that was originally being The term that was originally being

discussed was SSM, discussed was SSM, Supportive Safety Supportive Safety MeasuresMeasures..

Since the term “Prerequisite Programs” Since the term “Prerequisite Programs” was already being used, the Committee was already being used, the Committee decided to utilize that term in the decided to utilize that term in the Standard.Standard.


Discussion Points by TC-34Discussion Points by TC-34 What is a prerequisite program?What is a prerequisite program? Should there be mandatory programs?Should there be mandatory programs? Should programs be “only what an operation Should programs be “only what an operation

needs” to ensure safetyneeds” to ensure safety Should the Codex Food Hygiene document be Should the Codex Food Hygiene document be

adopted verbatimadopted verbatim How are prerequisite programs documented?How are prerequisite programs documented? How are prerequisite programs verified and How are prerequisite programs verified and

validated?validated?

PREREQUISITE PROGRAMS & ISOPREREQUISITE PROGRAMS & ISO 3.8 PRP - prerequisite programme ⟨food safety basic conditions and activities that are necessary to ⟩

maintain a hygienic environment throughout the food chain (3.2) suitable for the production, handling and provision of safe end products (3.5) and safe food for human consumption

NOTE: The PRPs needed depend on the segment of the food chain

in which the organization operates and the type of organization (see Annex C). Examples of equivalent terms are: Good Agricultural Practice (GAP), Good Veterinarian Practice (GVP), Good Manufacturing Practice (GMP), Good Hygienic Practice (GHP), Good Production Practice (GPP), Good Distribution Practice (GDP) and Good Trading Practice (GTP).


3.9 - operational PRP operational prerequisite programme PRP (3.8) identified by the hazard analysis

as essential in order to control the likelihood of introducing food safety hazards (3.3) to and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment


7.2 Prerequisite programmes (PRPs)

7.2.1 The organization shall establish, implement and maintain PRP(s) to assist in controlling

a) the likelihood of introducing food safety hazards to the product through the work environment,

b) biological, chemical and physical contamination of the product(s), including cross contamination between

products, andc) food safety hazard levels in the product and product

processing environment.

PREREQUISITE PROGRAMS & ISOPREREQUISITE PROGRAMS & ISO7.2.2 The PRP (s) shall

a) be appropriate to the organizational needs with regard to food safety,

b) be appropriate to the size and type of the operation and the nature of the products being manufactured and/or handled,

c) be implemented across the entire production system, either as programmes applicable in general or as programmes applicable to a particular product or operational line, and

d) be approved by the food safety team.The organization shall identify statutory and regulatory requirements

related to the above.


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 sectorstandards].


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 for cleaning,

maintenance and preventative maintenance;f) management of purchased materials (e.g. raw materials, ingredients,

chemicals and packaging), supplies (e.g. water, air, steam and ice), disposals (e.g. waste and sewage) and handling of products (e.g. storage and transportation);


The organization shall consider the following when establishing these programmes:

g) measures for the prevention of cross contamination;

h) cleaning and sanitizing;i) pest control;j) personnel hygiene;k) other aspects as appropriate.


Verification of PRP(s) shall be planned (see 7.8) and PRP(s) shall be modified as necessary (see 7.7). Records of verifications and modifications shall be maintained.

Documents should specify how activities included in the PRP(s) are managed.


• ISO 2200 is less than one year old, so “the jury” is out on how this concept will be accepted.

• Committee members are pushing for more rigid standards for ISO auditors who will be doing 22000 audits.

• Foods and food processing are vastly different operations than a company making batteries or light bulbs

ISO 22000ISO 22000ISO copyright officeCase postale 56 • CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail [email protected] www.iso.orgPublished in Switzerland

mailto:[email protected]

http://www.iso.org/

SUMMARYSUMMARY Food safety professionals have long Food safety professionals have long

acknowledged that sanitation, GMP’s and other acknowledged that sanitation, GMP’s and other areas are essential to food safetyareas are essential to food safety

Seafood HACCP – first to propose prerequisite Seafood HACCP – first to propose prerequisite conceptconcept

USDA HACCP regulationUSDA HACCP regulation Codex Food HygieneCodex Food Hygiene Industry and country standards – BRC, for Industry and country standards – BRC, for

example.example. ISO 22000ISO 22000 Prerequisite programs are here to stayPrerequisite programs are here to stay