General
When AGES was founded on June 1, 2002, the institute accepted the oversight of the entire food chain cycle. The over-arching field of knowledge that AGES holds, allows for the systematic control and analysis and therefore safety of foods as well as the best possible protection of health for people and animals.
In order to evaluate the potential risk to consumers, one must rely upon relevant data. AGES has subsequently widend its field of expertise. Since January 1, 2007, the agency has focused more intensively on data collection, statistics, risk assessment (DSR) of the information which has been gained from the agency’s laboratories. The resulting risk assessments can then be translated into useful risk management tools for application within Austria.
The prevention of nutrition-related diseases is the most important goal of AGES. On March 1, 2007, the AGES Centers for Nutrition and Prevention were established. The centers are an independent part of the agency which can be used as a platform for experts from a number of different fields including prevention, politics, industry and media. Using national and international knowledge, additional duties include the development of programs to aid in the prevention of nutrition-related diseases, establishment of improved basic conditions, the analysis of previous and current prevention measures, monitoring and evaluation, development of action plans, focusing on consumption behaviors and other nutrition-related epidemiological data, research and conceptualizing and following through with nutrition-related messages.
Through the development of effective and efficient risk communications, AGES has been recognized as a desirable and accredited source for media and other organizations, for example, in regard to mad-cow disease outbreaks and bird flu. In these cases, AGES could also contribute to the spread of information to the public through the use of telephone hotlines.
Since AGES was founded, the plant protection product traffic inspections have multiplied and the inspection of field samples and pesticide products has also doubled. The inspections of the Federal Office of Food Safety (BAES) are strict and reliable and are performed according to the risk assessment plan. During the inspections in 2005, a total of 78 tons of plant protection product were confiscated. The number of industry inspections has also increased dramatically in the past year. In 2004, every fourth importer and distributer was inspected compared with a further goal of inspecting every other importer and distributer per year. Furthermore, the goal will increase to inspect every single industry establishment within the span of the next two years.
Through these strengthened inspection practices, a network of distribution channels were discovered that are contributing plant protection products that are available which are not accepted in Austria. In addition to the systematic intensification of industry inspections, product inspections were also increased. One such measure is the detailed examination of plant protection product samples for their chemical composition. Furthermore, information networks within AGES and between partner organizations were improved to ensure better oversight of foods. Thus, the results of inspections of plant protection product applications are uniformly distributed to the appropriate organizations.
In addition, other organizations, such as Financial departments, the Agricultural Commodity Market of Austria (AMA) and the Environmental Crime Police will be informed about offenses against the plant protection product laws. When a potential crime has been committed, the claim will be handled by the appropriate authority. Under the leadership of AGES, the plant protection product inspection handbook and data bank will be established. In the future, the Lebensministerium, other countries and the Agricultural Commodity Market of Austria (AMA) will utilize these newly established tools. A large body of knowledge for information and training opportunities from AGES and the AGES Academy serve as the provision for, and supplement, the measures which are implemented by AGES.
The Federal Office of Food Safety is responsible for the area of food production which includes inspections of importers and distributers. Inspections are performed with a sound statistical basis and are corroborated with a goal and risk oriented verification system. Every year there are approximately 3,000 test samples which are analyzed. Food production facilities and manufacturers that are registered are inspected annually.
At this time, approximately 600,000 tons of extracted soybean meal is utilized in the conventional animal feed methods. 90% of this feed has been declared as genetically modified (GMO). The Austrian Agency for Health and Food Safety (AGES) has researched the possibility of transitioning to non- genetically modified feed for beef, calf, pork, chicken, turkey, egg and milk production together with the Federal Office of Health and Women’s Issues (BMGF), the Federal Office of Economics and Work (BMWA) and the Agricultural Commodity Market of Austria (AMA). The result indicates that such a transition is possible, although it would take time to produce a change in the entire food production cycle across all fields. This would also include higher costs as well as the need for the acceptance by consumers to pay for the products.
In Austria, the marketing and production of genetically modified organisms (GMO) is prohibited. Worldwide, however, the production of GMOs has risen every year. The various types of genetically modified corn have been cataloged and published by the European Union. These circumstances increase the risk for contamination of seeds with genetic modifications. Large-scale supervision and inspection and seed verification upon use is therefore essential. The main role of the Institute for Seeds of AGES is therefore the involvement and vigilance in regard to this issue. The seeds used in Austria are inspected, accepted, registered and organized by typology. The agency monitors the importers and distributers which bring seeds from other EU countries, as well as from outside of the EU. Despite the potential for contamination, the seeds used within Austria have been maintained as non-GMO. This speaks for the effectiveness of the AGES monitoring plans as well as the successful partnership with all persons and institutes involved in seed production.
AGES coordinates several research projects in search of alternative methods for fire blight prevention. Using controlled laboratory experiments in quarantined glass houses, natural antagonists of fire blight reduced the symptoms by half. Other projects are concerned with testing seeded fruits to improve fire blight tolerance in hopes to develop long term strategies in regard to the reduction of susceptibility of cultivated fruit varieties.
Salmonella poisoning remains the most common food-borne illness in Austria. Over the past three years, the number of reported cases has decreased by one-third. In 2003, there were 8271 reported cases while in 2006 there were 5615 cases. One such reason for this trend is that outbreaks are reported to the Centers for the Epidemiology of Infectious Diseases or the AGES National Reference Center for Salmonella.
AGES has also been acting as the primary authority for rabies cases within Austria since September 2005. With the motto: “Rabies – Recommendations for the Vaccination in Humans”, AGES has been working together with physicians from the Federal Office for Health and Women’s Issues (BMGF). This collaboration focuses on the continued effort to eradicate, what has been defined by the World Health Organization as, an “orphan disease.” The Rabies Counseling Department of AGES provides scientific information for physicians and patients in regard to the rabies situation within Austria as well as abroad. In addition, the department is the principal authority for case statistics and advises 28 vaccination sites from indicators to vaccination regimens after a bite to the possible encounter with a rabies-infected animal.
Since the discovery of the Legionnaire’s Disease in 1976, many countries have established surveillance systems to detect possible cases. In Austria, the AGES Institute for Medical Microbiology and Hygiene, located in Vienna, also the same location as the Reference Center for Legionnaire’s Disease, has acted as the national reporting and surveillance system for the past 15 years. Since 2001, every potential case and death thereof has been reported according to established epidemiological policies. This Reference Center is also connected to a Europe-wide surveillance system. Every year there are approximately 51 – 59 diagnosed cases of Legionnaire’s disease and approximately 6 – 8 cases die due to lung disease caused by the bacterium Legionella pneumophila. In many of the cases, the affected person contracted the disease during travel abroad. With the motto: “Control and Prevention of Travel-Associated Legionnaire’s Disease,” the experts from AGES work in partnership with the BMGF, providing federally employed physicians and providing risk reduction measures to operators of lodging establishments.
This year, the Institute for Medical Microbiology and Hygiene (IMED) in Graz, became the first medical microbiological diagnostics laboratory within Austria
During a clinical experiment in 2006, Austria has been established as one of the most reliable countries in Europe to identify the H5N1-Virus. The experiment took place in the EU-Reference Laboratory for Avian Flu in Weybridge, UK with 21 laboratories present. The Mödlinger Institute for Veterinary Examinations was only one of seven laboratories which was able to correctly identify the strain of the H5N1-Virus.
In 2005, a new BSE test was introduced. The new test enables the process to be shortened by one hour and therefore the test results can be sent back to slaughterhouses more quickly.
The presence of rabies in Austria is followed by the AGES-Institute for Veterinary Examination in Mödling, which also acts as the national reference laboratory for rabies. Every year, 20,000 samples are taken and analyzed from potentially infected animals.
The surveillance of potential outbreaks is performed through randomized sampling and testing and provides an essential contribution to the health status of animals within Austria. This also requires the development of new diagnostic methods such ear punch biopsy samples to determine bovine viral diarrhea virus (BVDV). In the past 4 years, a nation-wide Antibiotic Resistance Monitoring Program was established to identify zoonosis viruses and other ubiquitous germs.
Austria is one of the most proactive member countries of the EU when it comes to plant protection product residue inspection. The European Commission also praised Austria for examining a large number of active ingredients thus far. Despite the fact that the annual EU-wide performance tests include 126 laboratories from 25 countries, including Norway and Romania, AGES always performed in the top of the group. The two laboratories in Innsbruck and Vienna are among 36 examination locations that were deemed as „good“ in terms of being able to identify the number of active ingredients as well as the accuracy with which the active ingredients were identified.
AGES is a part of the European scientific network for the identification of pesticides. Through this platform, experts from a variety of countries can exchange research results and methods. As a result, current research can be adjusted to match the commonly found active ingredients. This also allows the research methods at AGES laboratories to be continually updated and expanded. This is evidenced by the ever-increasing number of samples as well as the researched ingredients that have been processed since the establishment of AGES. Currently there are 260 pesticide ingredients which are routinely examined. As a comparison, the EU only requires the examination of 69 ingredients at this time.
In the future, AGES laboratories will also function as National Reference Center according to the EU-Regulation 882/2004.
The field of food inspection reacts quickly to new problem areas, that appear more clearly through the establishment of the Rapid Alert System for Food and Feed-RASFF. Any new concerns that appear through this program are followed by AGES and evaluated in regard to the potential impact for Austria. New measuring methods (such as for acrylamide, cyanide in apricot seeds, and morphine in poppy seeds) are developed and this enables departments to react more efficiently to issues that arise. The efficiency of the food inspection aptitude of AGES is evidenced by the fact that there have not been the same food contamination scandals in Austria as there have been in Germany or England.
This new branch of AGES and the Federal Office for Safety in Health Care(BASG) is responsible for the fulfillment of all federal assignments and has become a national registration authority for medications and medical equipment with international recognition.
Every year, approximately 600 medications are released to the public. In the end of 2005, Austria had released approximately 9,000 pharmaceutical specialties for people as well as approximately 2,000 pharmaceutical brand medicine specialties. Released and registered homeopathic medicine specialties are also included in the Austrian pharmaceutical library, under „traditional medications“. The classification of pharmaceutical specialties is inconsistent and varies depending on the organization which inspected the product (there are two or three changes per pharmaceutical specialty/yea). The documentation requires strict regulations, which adheres to the same EU-wide criteria. Developments and new research results must be included in the updates of this documentation. In the area of pharmaceutical registration, 40 new staff has been hired, which has doubled the available experts in the field. Requests for release, which should normally take up to 7 months, would actually take several years and can now be accomplished in very little time. The public can now access more effective and safer medications more quickly while the Austrian economy is also supported. It is also important that the research results from pharmaceutical companies can be disseminated. The gradually developing counseling capability of the national pharmaceutical industry works in the same direction.
Contraindicated medications and the current surveillance of medications, is already available to the public and adopting EU standards. Notices and reports for the safety of medications are being evaluated and the appropriate precautionary measures are being authorized. This can be achieved through reorganization as well as 12 suggested changes which recently adopted. Through the adoption of consistent protocols, one can potentially prevent every second or third contraindicated medication cause of death as well as the prevention of every fourth case of an adverse reaction to a medication.
Even the market surveillance of medicines (including in-vitro diagnostics) and vigilance toward medical products and blood safety is now being accepted and taken more seriously by employees. Within the framework of the surveillance system is the task to address all serious instances associated with the use of medications, medical products, in vitro diagnostics, blood donations (ie, blood transfusions and blood products) and to assess, and if necessary, develop protocols for improved safety to prevent further issues from occurring. Unwanted incidences can lead to injuries, health complications, additional medical interventions or possibly death. Another important role of the Federal Office is the distribution of safety-related information to all health related organizations in Austria serves as a preventative measure for the reoccurrence of such issues. Products which are available in the market which do not comply with appropriate regulations or have been tampered or altered from their original version must be corrected or removed from the market.
The improved market surveillance for medications is an important development for public health. There are 21 inspectors currently working for AGES, in comparison to a few years ago when only one inspector held this position. Every year, there are more than 160 million medications provided to patients from pharmacies, clinics and hospitals. Therefore, it is important that medications are also monitored during production, transport and storage so that no problems can occur. The regular examinations are performed by PharmMed (ie, BASG) and must comply with EU policies and guidelines. If these inspections reveal improper production procedures, then specialized inspectors are notified to file a notice of negligence and to close the facility.
PharmMed monitors pharmacies and the wholesale market where medications are distributed. The medications are randomly tested and analyzed at the Official Medicines Control Laboratory (OMCL), according to international regulations, which can last up to 24 months. In addition, OMCL performs test purchases, especially from traditional Chinese medicines, from internet or other relevant stores based on current information from the network of laboratories in the EU. If these inspections encounter illegal or major discrepancies, then the laboratory results are reported to the appropriate authorities (ie, the market surveillance group inspectors of AGES). At OMCL, human blood products are examined with special attention to the potential contamination risk of Hepatitis or HIV.
The sale of medications over the internet displays a unique arrangement to harm public health. In the past five years, 170 counterfeit medications such as for Viagra or Tamiflu were available for purchase in the EU. Affiliated laboratories of PharmMed received and analyzed 17 samples of Viagra and other similar erectile dysfunction medication from internet pharmacies mainly from the Far East but also from the USA, Europe and black markets. Several of the samples revealed medication fraud.
The inspection of pharmaceutical products, such as medications for human consumption, as well as wholesale medications, is a required duty for the agency. The institute ensures an adequate supply of quality-assured blood products, especially of plasma and whole blood. Since veterinary supplies of poor quality may also affect the food chain, they are also subject to the same regulations and quality inspections. Clinical studies and research laboratories and statistics must also be inspected, both by the client as well as a physician who can verify the study. Even the inspection of preclinical and medication safety data through Good Laboratory Practice (GLP) and pharmaceutical vigilance must be guaranteed for public health. These well-defined procedures also correspond for the inspection and clinical corroboration of medical products.
Outsourcing not only supports public health but also influences the economy. At this time, the costs of such an operation are approximately 20 Million Euros per year which are carried almost exclusively by tax payers. Therefore, the services available can be offered in a more cost-effective manner: the pharmaceutical companies which produce the medications must also pay for them. As a result, there is an 80% reduction in associated costs for AGES and tax payers.