The quality assurance system used by the Dutch animal feed sector, GMP+, can be classed as one of the best and most rigorous systems of its type in the world. The Dutch system is driven by food safety and is based on the HACCP procedures of the feedstuffs industry and is, in certain respects, even stricter. Established by the Productschap Diervoeder (Product Board Animal Feed), it has been continually expanded and intensified over the years as practical experience has been gained.
The aim of GMP (Good Manufacturing Practice) regulations is to ensure that companies in the animal feed sector provide verifiable and transparent guarantees for the safety of food for humans, animals and the environment, throughout the entire production process.
GMP regulations for the animal feed sector were introduced in the Netherlands in 1992, to meet increasing demand for more quality guarantees in the animal production chain. The wave of publicity surrounding such events as cases of salmonella poisoning, increased levels of aflatoxin in American maize gluten meal, contamination of feedstuffs with lead ore during transportation in 1988, and additive residues (nicarbazin) in eggs from 1989, had already attracted attention to the influence of feed on the quality of animal products. IKB (Integral Chain Management) regulations were imposed by the Dutch poultry and pig husbandry sectors, and the feed sector was asked to offer firm guarantees regarding the safety of ingredients used in feed, based on process management.
MANAGING KNOWN RISKS
In 1992 a GMP standard was initiated for products in the chain supplied directly to farmers: compound feeds, pre-mixes and single-feed ingredients. A GMP standard for raw materials was added in 1994. In the beginning, compound feed producers were not obliged to purchase raw materials exclusively from GMP certified suppliers. Until mid-1999, the GMP regulations were primarily aimed at safeguarding known risk factors for additives, undesirable substances and hygiene (particularly salmonella). However, in 1996, a number of risk assessment-based management measures were included for high-moisture feedstuffs. The system was set up in compliance with the NEN ISO 9001 (Netherlands Standardization Institute - International Organization for Standardization 9001) norm.
Certain demands are made on the quality system, in addition to obligatory measures for effective management of critical phases during the process. Standards agreed with the dairy, egg and meat chains go over and above the statutory product standards. Monitoring by companies and the Product Board Animal Feed is also used to verify the effectiveness of these safeguards.
COPING WITH UNANTICIPATED CONTAMINATION
It became apparent that the assurance system was not equipped to cope with unanticipated contamination. The system’s focus was on known risk factors and was therefore a strongly reactive system; if a problem occurred, additional measures were included.
Over the years the number of standards continued to expand. Where GMP regulations were originally intended for compound feeds, single feedstuffs, pre-mixes and raw materials, in 1999 the regulations were extended to include transportation by road, water and rail. In 2001 the inclusion of additives was investigated and will be implemented in April 2004.
In 2002 it was decided successively to include feedstuff cultivation, storage and distribution of feedstuffs on pig farms, commencing in 2005. A standard to be applied to feedstuffs used in cattle and poultry production is in the pipeline.
In principle, this should provide full coverage of the entire animal feed chain with the agreed standards from cultivation of raw materials to the actual moment of feeding the animals.
DRIVE BEHIND INTENSIFICATION
The drive for further intensification of the quality system has its origins, in part, in certain incidents that had huge impact on the feed sector, an example of which is BSE (bovine spongiform encephalopathy, or mad cow disease). The first case of BSE in the Netherlands occurred in 1997. This lead to the government and farmers questioning whether BSE could have been prevented by a solid quality assurance system — even though, notably, GMP regulations contained the right measures to prevent cross-contamination.
A year later, problems occurred with a shipment of Brazilian citrus pulp contaminated by dioxin. This affair once again clearly brought to light the consequences that contaminated raw materials can have on further links in the animal production chain.
Another dioxin incident in Belgium involving feed fat occurred in 1999. Again the far-reaching consequences of contamination for the animal feed chain were painfully apparent. The Belgian dioxin affair had an immense effect on the consumption and production of poultry and related produce. The animal sector in the Netherlands exports approximately 60% of its production, and even though the Netherlands was untouched, the problems in Belgium had a knock-on effect for Dutch exports, which suffered considerable financial damage.
A final major incident occurred in 2002, when the hormone Medroxy Progesterone Acetate (MPA) was discovered in animal feed. Although the MPA contamination involved no risks for public health, the affair again had disastrous consequences for the animal feed and animal production industries.
QUALITY ASSURANCE INTENSIFICATION
Introduction of HACCP in the animal feed chain (1999). The Belgian feed fats case, with the 1998 Brazilian citrus pulp dioxin affair still fresh in the memory, led to a serious reconsideration of the facts. After a relatively brief period the ‘Plan of Approach to Intensify Quality Assurance in the Animal Feed Sector’ was outlined and implemented. The core points contained in the 1999 plan were:
• Transforming GMP regulations from a reactive to a pro-active system by introducing HACCP in the quality system (‘GMP+’), whereby risk assessment is carried out first and preventive measures are established based on the assessment;
• Expanding safeguards to cover the entire raw material chain by certifying raw material suppliers;
• Clear conditions for tracking and tracing to enable the cause to be quickly traced in the event of an incident and effective damage limitation measures;
• Initiation of an Early Warning System (EWS). This was intended to act as a safety net in cases where, in spite of all the measures in force, something still goes wrong because of unexpected circumstances, climatic conditions, human error or fraudulent practice.
Implementation of HACCP in companies is virtually complete. Quality assurance in the raw material chain is also in an advanced phase of implementation. Plans of action are still being carried out for certain product flows, with a planned date for completion of certification. Supplementary monitoring to maintain safety is also included, based on a risk assessment procedure.
Evaluation of the MPA affair (2002). The MPA affair also revealed a number of weak points. The main conclusion formed during the evaluation of this affair in November 2002 was that the incident was not primarily caused by failures in the current quality system or the level of standards, but in their interpretation by the participating (GMP+ approved) companies.
Following a period of careful consideration and intensive discussions with both the animal feed sector and the animal production chain, various measures for improvement were agreed on in April 2003. Implementation is underway.
The individual responsibility of the entrepreneur has been defined in the introduction of a Director’s Declaration model. This declaration of responsibility raises the individual’s awareness of his own responsibility for the quality assurance procedures within his own company and the possible consequences for other links in the production chain. It should be a motivating factor towards the consistent and conscientious application of quality assurance systems.
This should improve the effectiveness of quality assurance by requiring:
• Compulsory recall for products that fail to comply with GMP conditions and have damaging consequences for subsequent links in the chain;
• Approved products to be used only, for which the Product Board Animal Feed has published a risk assessment of both the product and the production process, based on HACCP. Companies must also always have a company-specific risk assessment protocol;
• Companies maintain a "black list" of forbidden products that can be used to identify banned feedstuffs. This is mainly aimed at eliminating waste products and products that have no significant function in the preparation process of animal feed or the resulting feed;
• An open raw material declaration, included in E.U. legislation to promote transparency;
• A physical and organizational separation between feedstuffs and waste products to prevent mixing;
• Implementation of the conditions laid down for tracking and tracing in November 2002, namely compulsory registration of the so-called Unique Farm Numbers (UFN) used on cattle farms. If an incident occurs both the feed suppliers and the dairy, egg and meat sectors can limit their preventive measures to farms that are actually involved;
• Introduction of an Early Warning System (EWS) and reporting suspect/rejected batches;
• A reduction in the number of mixing points and a ban on mixing identical moisture-rich feedstuffs originating from various locations in the food, fermentation and pharmaceutical industries, unless blending is carried out by a GMP-
approved company. Dry raw materials must not be mixed either — for example for standardization according to certain specifications — unless by a company that complies with the GMP standards for compound feed preparation.
New assessment and certification criteria. Preventive and repressive controls and supervision are supported by new assessment and certification criteria, which began in July 2003. Companies will be audited at least twice yearly, one of which is random. Inadequacies are classified into three categories (1, 2 and 3). Classification in category 1 and 2 will result in a temporary increase in the audit frequency.
The certification procedure has also changed. The policy (legislation and certification policy by the Product Board Animal Feed) and implementation
(certification of companies) have been separated. Now, specially accredited certifying bodies award certification.
The assessment and certification criteria include stringent conditions to classify inadequacies covered by category 1. Shortcomings may result in suspension or even withdrawal of the GMP certificate. At the present time, the withdrawal of a GMP certificate means that a company is excluded from participation for one year. Under the new regulations, this exclusion measure also extends to the actual person involved.
The final element of these tighter controls is an intensification of monitoring carried out by companies and the Product Board Animal Feed. The monitoring program will be periodically evaluated based on risk assessment and analysis results. A great deal of time and energy will be paid to this aspect in the coming period. The results of the monitoring program will be registered in the Databank of Undesirable Substances, which companies can use to help set up their own control procedures.
This package of measures is sure to have far reaching consequences on the prevailing culture within companies and possibly for the structure of the entire animal feed chain.
International participation in GMP+
Participation in the GMP+ system is not limited to the Netherlands. While some 1,500 Dutch company locations are GMP-certified, a further 1,600 locations are certified outside the country. The majority of these are raw material producers, however a large number of German and Belgian companies are compound feed producers.
Currently the number of facilities participating in the scheme outside the Netherlands are: Argentina 34; Belgium 250; Brazil 81; Canada 33; Germany 790; the Philippines 13; Finland 8; France 202; Great Britain 18; Indonesia 27; Eire 15; Malaysia 40; Thailand 39; and United States 137.
Johan den Hartog is the Secretary General, Productschap Diervoeder (Product Board Animal Feed), the Netherlands, a regulatory organization for businesses and for employees in the animal feed production chain.
The Board, which includes representatives from all parties in the animal feed chain, can
enforce regulations that are generally binding on all companies within the sector.
For further information, contact Johan den Hartog at firstname.lastname@example.org, or visit www.pdv.nl.