OF THE HACCP SYSTEM

It is e.g. It has been estimated (Miller, Personal communication) that annual losses in the United States and Canada due to the effects of mycotoxins on the feed and livestock industries are in the order of $5 billion. The intergranular water concentration is described either in relation to the equilibrium relative humidity (ERH, %) or water activity (aw).

The Trichothecenes

The Chinese outbreak, in 1984-85, was caused by moldy maize and wheat; symptoms occurred within five to thirty minutes and included nausea, vomiting, abdominal pain, diarrhea, dizziness, and headache.

Zearalenone

The Fumonisins

Exposure to fumonisin B1 (FB1) in maize causes leukoencephalomalacia (LEM) in horses and pulmonary edema in pigs. There is no evidence of carcinogenic activity of fumonisin B1 in female rats or male mice.

Ochratoxin A

The presence of the fumonisins in maize has been associated with the occurrence of esophageal cancer in humans in Transkei, southern Africa and China. However, the results of a recently completed study on the toxicology and carcinogenesis of fumonisin B1 have been reported (NTP, 1999) by the National Toxicology Program of the U.S. Department of Health and Human Services.

Patulin

The co-occurrence of mycotoxins

Mycotoxins of Regional Importance

Fungi and mycotoxins include those that have been associated with a variety of livestock diseases, including ergotism, paspalum wobblers, ryegrass wobblers, facial eczema, fescue foot, lupinosis, drooling syndrome and stachybotryotoxicosis (Lacey, 1991). During this period, crops can be colonized by fungi, with fungal development and fungal production dependent on the prevailing ecosystem.

THE SOCIO-ECONOMIC SYSTEM

For example, the topmost leaves of a plant will be exposed to extreme swings in temperature and relative humidity, while those leaves towards the bottom of the plant will represent a more shaded, temperate and humid environment; the surface texture of the leaf will also affect the microenvironment. Whenever efforts are made to improve the quality of food and feed, it must be clearly established that there is an unquestionable need for a higher quality product and that the community is prepared to bear any associated increase in the cost of the improved commodity.

THE CONTROL SYSTEM

The socio-economic system describes the social (eg cultural, political) and economic (macro and micro) factors that will have an important influence on events within the mycotoxicological system. In some cases, given the complexity and unpredictability of human behavior, it can be very difficult to successfully intervene in the socio-economic system.

INTEGRATION OF SYSTEMS

International Agency for Research on Cancer (IARC) (1993c) Toxins derived from Fusarium graminearum: zearalenone, deoxynivalenol, nivalenol and fusarenone and peanuts.

AN OVERVIEW OF HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)

An ounce of prevention is worth a pound of cure”

INTRODUCTION

Although designed as a food safety system for the agricultural and processing system, HACCP has so far found most application in the latter. This is mainly because it is much easier to use the HACCP system in a factory where there is only one management or 'owner' and where it is possible to completely prevent or eliminate or reduce to an acceptable level the danger to food safety. .

PRE-REQUISITE PROGRAMMES

The National Advisory Committee on Microbiological Criteria for Food (NACMCF) provided guidelines on HACCP in 1992, including generic plans and decision trees, and the Codex Alimentarius Commission adopted the HACCP system at its twentieth session in 1993. This Manual aims to address this subject, based on the approach as close as possible to the Codex Code of General Principles on Food Hygiene (1997), which emphasizes the importance of GMP/GAP/GHP as good foundations for the incorporate HACCP approach and develop a user-friendly food safety management system.

Good Agricultural Practices

In a commodity system, there are often many different "owners" of a commodity as it moves from farm to consumer, and complete control may not be achievable. Good storage practices (GSP) must be observed when storing goods on the farm.

Good Manufacturing Practices

Commodities or product to be transported in certain environments must be appropriately controlled, e.g. Containers used for bulk transfer must be specifically designated and labeled for food use.

BASIC PRINCIPLES OF HACCP

Conduct a hazard analysis

Determine the Critical Control Points (CCPs)

Establish critical limits

Establish a monitoring system

Establish a procedure for corrective action, when monitoring at a CCP indicates a deviation from an established critical limit

Establish procedures for verification to confirm the effectiveness of the HACCP plan

Establish documentation concerning all procedures and records appropriate to these principles and their application

DEVELOPING A HACCP PLAN

Establish a HACCP team
Describe the product
Identify the product’s intended use
Draw up the commodity flow diagram
On site confirmation of flow diagram
Identify and analyse hazard(s) - (Principle 1)
Determine the critical control points (ccps) - (Principle 2)
Establish critical limits for each ccp - (Principle 3)
Establish a monitoring procedure - (Principle 4)
Establish corrective action - (Principle 5)
Verify the HACCP plan - (Principle 6)
Keep record - (Principle 7)

The first activity of the HACCP team is to identify the scope of the investigation. It is also important to remember the stated scope of the HACCP analysis at this stage.

APPLICATION OF HACCP TO MYCOTOXIN CONTROL

Mycotoxin hazard analysis and identification of possible control measures

Manual and computerized records are equally acceptable, but a method of documentation should be devised that suits the size and nature of the business. Examples of the use of these forms are provided in the case studies presented in Chapter 3.

Hazard Analysis

Additionally, documentation can be used by a company as evidence of "Due Care Protection" as required, for example, by the Food Safety Act 1990 (HMSO), in the UK. Records to be maintained include: all processes and procedures related to GMP, GHP, CCP monitoring, deviations and corrective actions.

Guideline limits exist for fumonisin B1 and regulatory limits are likely to be set in the near future. The regulatory limits are taken as target levels and should be included in the product description table.

Identification of steps in the Commodity Flow Diagram (CFD) where mycotoxin contamination is most likely. It is rarely possible to be certain that pre-harvest mycotoxin levels are below regulatory or target levels in the commodity system, so post-harvest mycotoxin control measures can often only prevent or reduce FURTHER contamination rather than preventing the hazard entirely.

Determine Critical Control Points (CCPs)
Establish critical limits for each CCP
Establish a monitoring system for each CCP
Establish a corrective action
Establish verification procedures
Establish documentation and record keeping

If the risk of exceeding the acceptable mycotoxin level is considered to be low enough, then the HACCP team can define each step as a CCP. Critical limits for chemical detoxification may be reaction vessel temperature and pressure and residence time.

CONCLUSIONS

If it turns out not to be the case, troubleshooting should be done immediately to identify the step where the hazard got out of hand. Similarly, if an examination of discrepancies and product dispositions reveals an unacceptable level of control at a particular CCP, revisions will need to be made.

Definition of terms

Annex to CAC/RCP-1 (1969), Rev.3 (1997)

The acceptable level of the final product, sometimes referred to as the target level, must be stated in the product description and will normally be set at or below any regulatory limit. Target level: The acceptable level of a risk in the final product, such as the regulatory level of mycotoxin in a product description.

Tasks involved in developing HACCP system

Name of product

Full description of product including structure/variety, processing parameters,

Customer specification

Conditions of storage and distribution

Shelf Life

Packaging

Instructions on the label

Target Consumer

Recommendation for further processing required before consumption

An example of decision tree to identify CCPs

The definition of control measure in Codex 1997 has been modified slightly for application to the production chain. The definition now includes activities used to prevent

Answer questions in sequence

An Example of a HACCP Worksheet

Describe Product

Commodity Flow Diagram

HACCP Analysis Plan

ILLUSTRATIVE EXAMPLES OF APPLICATION OF HACCP TO MYCOTOXIN CONTROL

The examples have a strong preference for aflatoxin, as this is the most regulated mycotoxin. The format used to present the examples is a brief introduction, followed by an overview of the 12 phases of HACCP, including a description and intended use form, a material flow diagram and a HACCP plan worksheet.

Introduction

The HACCP team
and 3. - Product Description and Intended Use
and 5 - The Commodity Flow Diagram (CFD), Verified
Mycotoxin hazard analysis and identification of possible control measures

Other mycotoxins that may be present include: zearalenone, one or more trichothecenes, and fumonisins. In this case, aflatoxin is the only mycotoxin transferred to Task 7. b) Identification of steps in the Commodity Flow Diagram (CFD) where mycotoxin contamination is most likely to have occurred.

Steps 1, 2, and 3: on farm, through growing and including harvest

on-farm inspection of cobs
on-farm accumulation of cobs and storage
shelling
drying and accumulation at Primary Trader
drying and storage at a secondary trader
feed mills and export silos
to 10: Development of a HACCP Plan
Farm, growing in the field – GAP
Farm, at field maturity – GAP
Farm, at harvest – CCP1
Inspection on farm – CCP2
Accumulation and storage of cobs on-farm – CCP3
Shelling - GAP
Primary Trader – CCP4
Secondary Trader – CCP5
Feed mills and export silos –CCP6
Establish Verification Procedures
Establish documentation and record keeping

Surveys during the rainy season confirmed that aflatoxin contamination is highly likely at this stage. This step is intended to be a CCP with drying to a moisture content of 14% (no fraction >15%) prior to storage as a control measure.

Mycotoxin hazard analysis and identification of possible control measures
Procurement and storage
Milling
Storage of milled maize
Mixing of feed ingredients
Pelleting
Packaging
Labelling
Storage of mixed feed
Transportation
Retailing
Farm storage and use
Procurement and storage, CCP1
Milling of maize, GMP
Storage of milled maize, GSP
Mixing of feed ingredients, GMP
Pelleting of feed, CCP2
Packaging of feed, GMP
Labelling of feed, GMP
Storage of feed, GSP
Transportation, GMP
Retailing, GSP
Farm storage and use, GSP/ GAP
Establish verification procedures
and 3 - Product Description and Intended Use, Verified

Secondary/ City traders GMP Storage

This step must be carried out correctly to ensure that the aflatoxin content of the compound feed remains within the target level. Validation procedures are required for each of the CCPs and overall verification of the HACCP plan is provided by aflatoxin results on representative samples of feed lots leaving the feed mill.

Oil Mills

Expelling/ Extracting/

CCP3 to yield copra cake/ meal

Farm, harvesting and dehusking – CCP1

The critical limit will be set at zero cracked nuts and will be monitored by trained pickers or weaners.

Farm, splitting nuts – GAP

Farm, drying – CCP2

Controlled drying and storage tests conclusively demonstrated that direct smoke drying protects copra from aflatoxin contamination: for safe storage, copra only needed to be dried to a moisture content of ≤16%, while copra dried in hot air or sun dried evenly to ≤12% to prevent aflatoxin contamination. CCP validation will be achieved by measuring the moisture content of the product.

Secondary traders, procurement and storage – GMP/ GSP

This practice often leaves copra at unsafe moisture levels for more than 48 hours and results in a greatly increased risk of mold and aflatoxin contamination. Lower quality copra will dry in the store and successive colonies of mold will grow until the safe moisture content of 12% is reached.

Oil mills, procurement – GMP

Good storage practices, such as pallet storage in a warehouse with good ventilation and a sound roof, will prevent rewetting and subsequent contamination with mold and aflatoxin (Head, S. W., 1999).

Oil mill, expelling/ extracting/ pelleting – CCP3

Shipment – GMP/ GSP

The commodity system proposed here is similar to those systems frequently found in sub-Saharan Africa, where the small-scale production of peanuts is practiced in combination with the commercial production of peanut butter. Groundnut processing systems are very complex, involving a variety of manufacturing lines producing different specified products; a single product line is considered in the present example.

Small-scale commercial or peasant farmers' crops are usually short-season, low-input cultivars (cvs) intended to be grown within the rainy season without irrigation. Aflatoxin is the only mycotoxin hazard for which the region has regulatory limits for peanuts and is therefore the only mycotoxin considered.

On farm, pre-harvest

On-farm harvesting

On-farm, removal of pods from haulm

Farm to trader or processor

At factory, aflatoxin testing of incoming batches of groundut kernels There is no risk of additional contamination at this step

At factory, roasting

At factory, hand-sorting

On-farm harvesting - GAP

On-farm, sorting during removal of pods from haulm – CCP3

Farm to trader or processor - GAP

At factory, aflatoxin testing of incoming batches of groundut kernels

At factory, roasting - GMP

At factory, hand-sorting - GMP

Establish verification procedures

There is a significant risk that patulin levels in apple juice produced in South America will exceed a 50 µg/kg target level. Apple juice produced in Latin America differs from that produced in Europe in that it has added sucrose and water, as well as the preservative sodium metabisulphite.

Patulin contamination is likely to be produced in the orchard during growth (Step 1) and during bulk storage (Step 3). Patulin contamination is likely present in the apples, or the resulting apple juice, at every step in the commodity chain.

Farm, growing in the orchard - GAP

Patulin can also be removed from apple juice by filtration, when patulin bound to solid particles of apple flesh is removed. Inactivation of Penicillium expansum spores during pasteurization at Step 11 will reduce the risk of patulin production in the finished juice.

Farm, at harvest – CCP1

Control Measures Control Critical limits Monitoring

Corrective actions

Records

Farm, bulk storage - GAP
Transportation – GAP
Factory procurement – GMP
Factory sorting – CCP2
Factory, washing – CCP3
Bulk storage of whole apples – CCP4
Pressing/ extraction process – GMP
Filtration – CCP5
Pasteurisation – CCP
Asceptic packaging process - GMP
Storage and dispatch - GMP

The critical limits for this CCP will be related to the pressure of the sprays and the duration of the washing step. Although it is unlikely that patulin levels will be significantly reduced during pasteurization, mold spores will be destroyed and the risk of patulin being produced later in the apple juice will be reduced.

Slow-lane (Steps 2 through 7)

Factory

109Mechanical Drying

Factory

110Steps 1: On farm, pre-harvest

On-farm harvesting

Farm drying of nuts in hull

Farm, storage of nuts in hull

Primary and Secondary Trader

Factory Procurement and storage of nuts in hull (slow lane)

111Step 7: Factory de-hulling

Factory floatation

Factory drying (and storage in the fast lane)

Factory sorting

Roasting and salting

Factory, aflatoxin testing and grading

112Step 13: Factory packing

Factory storage of finished product
Factory export
Farm, preharvest – IPSM/GAP
on-farm harvesting – CCP1
Farm, drying of nuts in hull – CCP2
Farm, storage of nuts in hull - GSP
Primary and Secondary Trader - GSP
Factory, procurement and storage of nuts in hull (slow lane) – GMP/ GSP
Factory de-hulling - GMP
Factory floatation - CCP3
Factory drying – CCP4
Factory sorting – CCP5
Roasting and salting - GMP
Factory, aflatoxin testing and grading – CCP6
Factory packing - GMP
Factory storage of finished product -GMP
Factory export - GMP

The critical limit will be set at <=1% damaged nuts remaining after inspection and the CCP will be monitored by visual observation. Critical limits will be set for the operating temperature of the dryer, and the residence time in the dryer.