<p> Organic Product Safety Management Policies and Systems in Germany and Taiwan Chang-Ju Huang-Tzeng Department of Applied Economics, National I-Lan University</p><p>Abstract The main purpose of this study is to understand and compare the organic product certification systems of Germany and Taiwan, including their respective division of labor, relevant laws and regulations, and approval and supervision of certification organizations, and to illuminate the two countries' safety management methods, including quality monitoring, risk assessment, data management, and crisis handling. </p><p>Since Taiwan has not yet legislated organic agriculture regulations, and still has much work to do before it reaches that point, Germany's organic agriculture laws and regulations, and division of labor among management units, may well serve as an example for Taiwan.</p><p>The certification systems of Germany and Taiwan are identical. Both countries employ private certification under government supervision. But in comparison with Germany, Taiwan's supervision of certification organizations and approval and oversight of certification personnel need further strengthening in order to improve certification quality. Taiwan can also learn from Germany's risk management principles when strengthening supervision of certification units, certification personnel, and certified farms. As for quality monitoring,</p><p>Taiwan has been more aggressive than Germany in pesticide residue testing and public announcement of testing results, and in the online management and announcement of certification data. On the other hand, Taiwan lacks Germany's certification management risk analysis and control, as well as Germany's rapid notification when a problem affecting an organic problem occurs. </p><p>1 Keywords: organic agriculture, food safety, policies and systems</p><p>2 I. Introduction</p><p>The biggest and most important difference between organic products (including agricultural products, foods and animal feed; same below) and conventional products is that the production of the former emphasizes protection of the environment and ecology, and does not involve the use of any hazardous substances. Nevertheless, there is no significant difference in appearance between organic products and ordinary products, and testing for pesticides or other chemical residues cannot guarantee that organic products are completely free from chemicals or other unwanted matter. Therefore, in order to insure that the organic product production process complies with relevant regulations, many countries have gone beyond drafting organic laws and regulations by also formulating implementations steps or guiding principles. </p><p>This study chiefly investigates Germany's organic product safety management regulations and methods of implementing quality monitoring, risk assessment, data management, and crisis handling, makes comparisons with relevant regulations and methods in Taiwan, and finally proposes recommendations concerning organic product management in</p><p>Taiwan. </p><p>II. Organic Product Management System </p><p> summarizes the relationships between organic product management laws and regulations in Germany and Taiwan. The European Union's "Council Regulation on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs" (EEC, 2004; referred to below as the "EU Organic Regulation") has legal force in all EU member states, and must therefore be upheld in Germany. The EU Organic</p><p>Regulation chiefly governs rules of production, inspection systems, and product import. </p><p>3 Table 1 Organic Product Management Regulations in Germany and Taiwan</p><p>Germany Taiwan Regulation Drafted by Time Regulation Drafted by Time drafted (responsible drafted unit) Organic Regulation European Union 1991 Organic Agricultural COA 2003 Product Management (Agriculture Operating Guidelines and Food Agency) Organic Agricultural COA 2003 Product Production (Agricultur Regulations – Crops e and Food Agency) Organic Agricultural COA 2003 Product Production (Animal Regulations – Industry Livestock Department) Organic Agriculture BMVEL 2002 None Law</p><p>Private BLE 2003 Organic Agricultural COA 2003 Certification Product Certification Organization Organization Approval Approval Operating Procedures Procedure Rules Certification Länder Government 2004 None Organization Joint Organic Work Supervision Rules Team Organic Logo Act BMVEL 2001 None Organic Logo BMVEL 2002 None Format and Usage Regulations BMVEL: The German Ministry of Consumer Protection, Food and Agriculture</p><p>Source: Adapted by this study. </p><p>Regulations similar to the EU Organic Regulation in Taiwan include the "Organic</p><p>Agricultural Product Management Operating Guidelines" governing the certification system and the "Organic Agricultural Product Production Regulations – Crops" and "Organic</p><p>4 Agricultural Product Production Regulations – Livestock" governing rules of production. </p><p>Articles of the EU Organic Regulation governing the inspection system include Article 8,</p><p>Article 9, and Annex III, which specifies minimum inspection requirements and early warning measures. The EU Organic Regulation stipulates that the targets of inspection shall include producers, preparers, and importers, which are collectively termed "operators." This implies that farms, processors, importers, restaurants, packaging plants, and processing plants are subject to inspection. Those firms that do not perform any packaging and processing operations, or that perform repackaging or cutting (of meat or cheese, for example) in front of consumers, or that allow consumers to select desired portions from large packages (bags, boxes, buckets) before packaging and sale are not subject to inspection. However, consumers and consumer groups have occasionally questioned the stipulation that retailers are not subject to inspection. </p><p>The EU Organic Regulation specifies the following concerning organic inspection systems: </p><p>1. In order to regulate operators, a country shall establish an inspection system implemented</p><p> by one or more authorities or private organizations empowered to perform inspection. </p><p>2. A country shall take necessary measures to ensure that operators that comply with organic</p><p> regulations and pay for inspection expenses have the right to use the inspection system. </p><p>3. With regard to participation of private organizations certification, a country shall</p><p> empower an authority to approve and supervise private certification organizations. </p><p>4. When a country approves a private organization to perform certification, the country shall</p><p> pay attention to the organization's standard operating procedures for certification work,</p><p> punishment of violators, organizational resources (qualified work personnel,</p><p>5 administrative and technical ability, certification experience, reliability), and objectivity of</p><p> operator certification. </p><p>5. After a certification organization has been approved, the government authority shall bear</p><p> responsibility for (1) ensuring that the certification organization is able to objectively and</p><p> effectively implement certification, (2) hearing any violations discovered and</p><p> implementing punishment, and (3) revoking approval when the certification organization</p><p> fails to comply with regulations. </p><p>A government shall ensure traceability of meats and relevant livestock products throughout the entire production chain. Beyond complying with the EU Organic Regulation, the German government's organic product management must also comply with relevant domestic laws including the Organic Agriculture Law (Gesetz zum ökologischen Landbau)</p><p>(BMVEL, 2002a.), the Organic Logo Act (Gesetz zur Einfürung und Verwendung eines</p><p>Kennzeichens für Zeugnisse des ökologischen landbaus, also referred to as Öko-</p><p>Kennzeichengesetz or ÖkoKennzG) (BMVEL, 2001.), and the Organic Logo Format and</p><p>Usage Regulations (Verordnung zur Gestaltung und Verwendung des Öko-Kennzeichens, also referred to as Öko- Kennzzeichenverordnung or ÖkoKennzV) (BMVEL, 2002b.). </p><p>Germany drafted the Organic Agriculture Law in order to implement the EU Organic</p><p>Regulation. This law consists of 15 articles, and explicitly specifies matters including the implementing authority, certification system (Kontrollsystem), approval and revocation of the certification organization, mission of the certification organization, customs cooperation, supervision, data notification, expenses and costs, authorization, punishments, fines, and confiscation, etc. </p><p>The German Ministry of Consumer Protection, Food and Agriculture (referred to below as the BMVEL) is the government agency in charge of organic agriculture. In accordance</p><p>6 with the Organic Agriculture Law, the following government entities and the private certification organizations play roles in the certification mechanism: </p><p>1. When not specified, Länder government authorities shall bear responsibility in accordance</p><p> with state laws. </p><p>2. The Department of Food and Agriculture (Bundesanstalt für Landwirtscheaft und</p><p>Ernährung, abbreviated as BLE) is responsible for the following tasks:</p><p>（1） Approval and revocation of private certification organizations</p><p>（2） Issuance of code numbers to approved private certification organizations</p><p>（3） Issuance of sales licenses to imported products</p><p>3. Duties of Länder governments: </p><p>（1） A Länder government shall entrust its inspection duties to a certification</p><p> organization that is able to perform said duties in an independent, professional, and</p><p> reliable manner, or shall provide a natural person or juristic person with duties</p><p> similar to those of a certification organization, or shall participate (or cooperate)</p><p> with them to implement inspection duties. </p><p>（2） A Länder government shall formulate entrustment and cooperation</p><p> conditions and procedures. </p><p>（3） A Länder government shall supervise its certification organization. </p><p>（4） If circumstances constituting grounds for revocation of the certification</p><p> organization are discovered, a Länder government shall notify BLE and request</p><p>BLE to implement approval revocation procedures.</p><p>4. Customs cooperation: </p><p>（1） The Ministry of Finance and its subordinate customs agency shall cooperate</p><p> in the supervision of imported organic products. </p><p>（2） The Ministry of Finance and its subordinate customs agency shall bear</p><p>7 responsibility for reporting infractions, performing registration, and notification,</p><p> and shall bear responsibility for inspecting relevant documents and examining</p><p> samples or specimens. </p><p>5. Responsibilities of certification organizations:</p><p>（1） Unless the Länder government authority consents to rejection of the application, a</p><p> certification organization shall bear responsibility for performing certification of</p><p> any corporate entity that has paid necessary expenses. </p><p>（2） A certification organization shall report any violations of regulations discovered</p><p> at the time of certification to the Länder government authority. </p><p>In accordance with relevant German laws and regulations, and referring to other research</p><p>(Neuendorff, 2003 and www.soel.de), this study has schematized Germany's organic product management system as shown in Fig. 1; this diagram sheds light on the duties of various agencies and their interrelationship. Apart from the foregoing government certification system, organic farming associations also certify their member enterprises. Germany relied solely on private certification mechanisms prior to the drafting of the EU Organic Regulation.</p><p>Although the number of operators participating in organic farming association certification increased after the adoption of government certification mechanisms, their percentage fell from 87.9% in 1996 to 58% in 2003 (SÖL, 2004). While most organic farming associations recommend certain appropriate certification companies to their members, enterprises can freely select certification organizations, and if an enterprise needs association certification, the certification company shall simultaneously perform government certification and association certification of the enterprise. </p><p>As for imported products, BLE has drafted the "Rules Governing Importers of Organic</p><p>8 Products from a Third Country to the European Union" (Leitlinien für Importeure</p><p>ökologischer Erzeugnisse aus Drittländerrn in die Europäische Union gemäß Verordnung</p><p>(EWG) Nr. 2092/91 in geltender Fassung) in accordance with the EU Organic Regulation. </p><p>EU 6 3 Customs BMVEL 3 6 6 6 Farmers 1.application BLE Länder autorities Associations 5 2 5 2.approval 2 1 6 3</p><p>3. authorization 1 Certification Companies 1 1 4. certification 1 4 6 1 4 6 4 6 5.supervision Importers Processors Farms 6. notification 7 7. labeling Trade</p><p>Figure 1. Germany Organic products management system</p><p>Fig. 2 is a schematic view of Taiwan's organic product management system based on organic agriculture regulations, including the Organic Agricultural Product Management</p><p>Operating Guidelines, Organic Agricultural Product Production Regulations – Crops and –</p><p>Livestock, Organic Agricultural Product Certification Organization Approval Operating</p><p>Procedures, and Organic Agricultural Product Certification Organization Certification</p><p>Procedures (Council of Agriculture, 2004). </p><p>9 COA 3 6 Agricultural Research Agriculture and Food Agency Animal Industry and Extension Stations 3 Department 3 Food Production Agricultural Certification Guidance Section Materials Section Certification Guidance Commission for 1 5 2 Commission for crops livestocks？ 5 5 5 4 6 2 Certification organizations Organic Livestock 2 Product Certification 1 6 1 Guidance Commission ？ 6 Rice farms Other crop farms Livestock farms ？ 7 1.application Trade</p><p>2.application 5. supervision Figure 2 Taiwan's Organic Product 3.authorization 6. notification Management System</p><p>4.certification 7. labeling</p><p>As in Germany, farmers must obtain certification from certification organizations, and certification organizations must obtain approval from a government authority. The main differences are that Taiwan has not yet enacted its Organic Agricultural Product Management</p><p>Operating Guidelines, and has not yet determined a national organic Logo to identify organic products. As a result, non-certified products are commonly marked as being organic products. </p><p>The Agriculture and Food Agency is the organic crop authority in Taiwan, and it has established the Organic Agricultural Product Certification Guidance Commission to perform consulting tasks. A certification organization (must be a nonprofit organization) may apply to the government for approval in accordance with the Organic Agricultural Product</p><p>Certification Organization Approval Operating Procedures. Certification organizations bear</p><p>10 responsibility for certification of organic agricultural products. The Agricultural Materials</p><p>Section of the Agriculture and Food Agency is currently responsible for evaluation and approval of crop certification organizations, and the Animal Industry Department of the</p><p>Council of Agriculture (COA) is the authority in charge of organic animal products. Although production regulations have been determined for animal products, there are not yet any organic animal product certification organizations (the Animal Industry Department is currently assisting the National Animal Industry Foundation to serve as a certification organization) or organic livestock farms. And while the Organic Agricultural Product</p><p>Management Operating Guidelines explicitly state that imported products may apply for certification from a Taiwanese certification organization, no imported products have applied for certification thus far. </p><p>Taiwan has not yet drafted principles for the supervision of certification organizations.</p><p>As for product supervision, the Agricultural Materials Section of the Agriculture and Food</p><p>Agency bears responsibility for monitoring organic crop products (apart from rice), and sampling work is entrusted to agricultural research and extension stations. The Food</p><p>Production Section of the Agriculture and Food Agency bears responsibility for monitoring of organic rice. The assigning of three units to bear responsibility for different products prevents the unification of duties and powers, and does not incorporate city and county governments in the organic product management system. This is certainly not an ideal division of labor. </p><p>Germany also has a food certification system in addition to its organic certification system, it was established in 2001 and termed the "quality and safety system" (Qualität und</p><p>Sicherheit System, abbreviated QS). This system consists of three levels: corporate self- management, certification by a certification organization approved by the QS company, and</p><p>11 management of the certification organization by the QS company1. The QS company was established by six major national associations2 and performs certification of meat products.</p><p>Certification items have now expanded to cover vegetables and fruit. Many organic operators also obtain this certification, and organic certification companies ordinarily also perform QS certification.</p><p>Approval and Supervision of Certification Organizations </p><p>Organic certification systems are different in various EU countries. Denmark and Finland have adopted national certification systems; there is no "certification" of operators under these systems, but inspectors perform supervision and inspection of operators. Austria employs certification by private organizations, and an accreditation organization performs supervision and management of certification organizations. The Netherlands has only one certification company responsible for nationwide certification. And Germany employs certification by private organizations under government supervision. </p><p>Since BLE must approve private certification organizations accordance with the Organic</p><p>Agriculture Law, BLE has therefore drafted the Private Certification Organization Approval</p><p>Procedure Rules (Leitlinien zum Zulassungsverfahrung der privaten Kontrollstellen) (BLE,</p><p>2003). The following is a summary of the main sections of the Rules; this information may be useful as a reference for Taiwan: </p><p>1 Please see http://www.q-s.info/ for further information. 2 Deutscher Raiffeisenverband e. V. (Stufe Futtermittel),·Deutscher Bauernverband e. V. (Stufe Landwirtschaft), Verband der Fleischwirtschaft e. V. (Stufe Schlachtung und Zerlegung), Bundesverband der Deutschen Fleischwarenindustrie e. V. (Stufe Fleischwarenindustrie), Handelsvereinigung für Marktwirtschaft (Stufe Lebensmitteleinzelhandel), CMA Centrale Marketing-Gesellschaft der deutschen Agrarwirtschaft mbH (für die Kommunikation mit dem Verbraucher)</p><p>12 1. Approval of certification organizations: </p><p>BLE may, in accordance with a certification organization's application, restrict that</p><p> organization to performing certification in only one certain state. </p><p>1.1 Application and approval procedures. </p><p>1.2 Certification agency preconditions: Must meet basic personnel and equipment</p><p> requirements. </p><p>German certification organizations are by no means limited to nonprofit</p><p> organizations, and organic farming associations do not perform certification. German</p><p> certification organizations are consequently all for-profit enterprises. The statutory</p><p> executive or principal of a certification organization must possess an M.S. in</p><p> agricultural science (Dipl.-Ing. Agr.) or an equivalent academic background, many</p><p> years of organic agricultural experience, and a basic understanding of corporate</p><p> organization, administration, accounting, quality management, and law (especially the</p><p>EU Organic Regulation). </p><p>While the qualifications of certification personnel may vary due to certification</p><p> organizations’ different areas of certification, all must possess relevant academic</p><p> backgrounds, licenses, or national examination credentials. Certification personnel in a</p><p> specific area may perform certification work only in that area. </p><p>1.3 Certification organization working documents: Standard contracts with operators</p><p> receiving certification, sanctions, and handling principles. </p><p>1.4 Sufficient insurance coverage: A certification organization must purchase insurance</p><p> reflecting the amount of risk to comply with the requirements of EN45011 (4.2h).</p><p>Neither the federal government nor any Länder government shall underwrite the</p><p> damage liability obligations of a certification organization. </p><p>1.5 Responsibilities of certification personnel: Certification personnel shall be approved</p><p>13 by BLE, and shall be supervised by each state authority. A certification organization</p><p> shall bear responsibility for the work of its certification personnel. </p><p>1.6 Areas of certification: BLE shall approve a certification organization's specific</p><p> certification area in accordance with the standard certification proposal and</p><p> manpower and technical capabilities in the quality management handbook submitted</p><p> by the certification organization. Certification areas are specified in Annex 3 of the</p><p>EU Organic Regulation; see section 3.1 below for an explanation of certification</p><p> areas.</p><p>1.7 Certification organization code numbers: Taking DE-999-Öko-Kontrollstelle as an</p><p> example, DE indicates Germany, 999 is a serial number, and Öko-Kontrollstelle</p><p> means "organic-certification organization." </p><p>2. The government imposes the following requirements on approved certification</p><p> organizations:</p><p>2.1 Maintenance of certification capability: Certification personnel working in</p><p> certification areas A1, A, B, C, and/or E shall complete at least 20 full certification</p><p> cases each year, and shall submit proof to the respective Länder government</p><p> authority. </p><p>2.2 Inspection of certification personnel work: In order to minimize risk, the Länder</p><p> government authority shall inspect the ability, experience, and reliability of said</p><p> personnel on a random basis in conjunction with certification tasks. </p><p>2.3 On-site inspection of certification organizations: The BLE shall perform an on-site</p><p> inspection when a certification organization application is received. Länder</p><p> government authorities are afterwards responsible for inspecting each certification</p><p> organization once each year whenever possible, and may also implement supervision</p><p>14 via certification procedures. </p><p>3. Registration of certified enterprises:</p><p>3.1 Registration: </p><p>Enterprises shall fill out the attached form and submit it to the local Länder</p><p> government authority for registration. When the enterprise and certification</p><p> organization have signed the contract, the certification organization shall issue the</p><p> enterprise a serial number that may be used for marking purposes. </p><p>Enterprise serial numbers consist of five sets of characters; taking D-BW-099-</p><p>09999-A as an example, D indicates Germany; BW is an abbreviation of the Länder</p><p> name (Germany’s 16 Länders each have their own abbreviation), 099 is a certification</p><p> organization code, 09999 is the enterprise's serial number, and A is the certification</p><p> area. An enterprise can apply for certification in one or more areas. Certification areas</p><p> include:</p><p>A: Agricultural production; A1 is for plant products, A2 is for animal products; if not</p><p> specified, the enterprise produces both crops and livestock. </p><p>B: Processing </p><p>C: Importing (internal transport within the European Union is not considered</p><p> import/export) </p><p>D: Enterprises engaging in production, preparation, or import fully or partially on</p><p> behalf of other parties</p><p>E: Animal feed processing </p><p>H: Storage industry (this new area was added on July 1, 2005), including wholesalers</p><p>3.2 Termination of certification contract and change of certification agency.</p><p>4. Certification of enterprises: A certification agency shall implement certification tasks in</p><p> accordance with the standard certification proposal approved by the BLE. </p><p>15 4.1 General requirements: On-site inspection of enterprises and their relevant documents</p><p> and records. Inspection records; apart from routine annual inspections, at least 10% of</p><p> all farms shall be inspected annually on a random basis. </p><p>4.2 Requirements for each certification area. </p><p>5. Reporting obligations of certification organizations: </p><p>5.1 Annual reports </p><p>5.2 Reports of extraordinary incidents </p><p>6. Resolution of appeals: </p><p>6.1 Enterprise appeals to certification organizations: A certification organization shall</p><p> determine procedures for handling certification-related appeals. </p><p>6.2 Certification personnel appeals to certification organizations: A certification</p><p> organization shall determine procedures for resolving differences of opinion</p><p> concerning certification on the parts of certification personnel and certification</p><p> executive personnel; cases shall be forwarded to the state authority for resolution if</p><p> agreement cannot be reached. </p><p>Appendix: </p><p>A. Certification organization application form</p><p>B. Minimum requirements made of the standard certification proposal of a certification</p><p> organization </p><p>C. Certification personnel experience and educational history form </p><p>D. Model enterprise registration form</p><p>E. Model certification work report </p><p>F. Registration procedures for certification personnel </p><p>Apart from complying with the foregoing Private Certification Organization Approval</p><p>16 Procedure Rules, German certification organizations must also comply with EN45011 or</p><p>ISO65 safety management standards (general requirements of organizations implementing food certification systems); however, in accordance with Article 9, Point 11 of the EU Organic</p><p>Regulation, certification organizations do not need to be "accredited." </p><p>Germany's Länder governments and the BLE cooperate and maintain contact with each other in order to strengthen supervision mechanisms and ensure consistent supervision standards. The Länder governments and the BLE have therefore organized the “Länder</p><p>Government Joint Organic Work Team (Länder-Arbeitsgemeinschaft zur Verordnung (EWG)</p><p>Nr.2092/91 über den Ökologischen Landbau, abbreviated LÖK) and have determined the</p><p>"Certification Organization Supervision Rules" (Leitlinien zur Überwachung der</p><p>Kontrollstellen) (LÖK, 2004). The Supervision Rules generally follow the EU Organic</p><p>Regulation, Germany's Organic Law, and the BLE's Private Certification Organization</p><p>Approval Procedure Rules. The Supervision Rules clearly specify the various tasks to be implemented by the BLE and state authorities, and working timetables, and include three appendices for the reference of state authorities: </p><p>1. A model checklist for joint certification or follow-up certification: Joint certification,</p><p> accompanied unit, and personnel data; certified enterprise data; and inspection of the</p><p> inspection tasks performed by the accompanied certification personnel. Checklists include</p><p> both general inspection checklists and inspection checklists for each certification area. </p><p>2. Model certification organization office inspection checklist (not yet produced) </p><p>3. Model registration form for certification visits</p><p>It can be seen from the list of German and Taiwanese organic products management regulations in that Taiwan also has Organic Agricultural Product Certification Organization</p><p>17 Approval Operating Procedures, the content of which mainly describes the documents a certification organization must prepare at time of application, and approval items and processes. Taiwan currently has three approved certification organizations, one unapproved organization, and one organization still in the application process. With regard to supervision of certification organizations, although the Organic Agricultural Product Management</p><p>Operating Guidelines specify that certification organizations are subject to government evaluation, the government does not yet actually inspect certification organizations or supervise their certification work. While the Agriculture and Food Agency Agricultural</p><p>Materials Section performs a simple rating of certification organizations when allocating subsidies, the rating items only address certification area and product pesticide residue monitoring results. The unfairness of rating items weights certainly deserves discussion. It is therefore true that the Taiwan government is not obligated to supervise certification organizations. </p><p>As for the approval and evaluation of certification personnel in Germany, the BMVEL has entrusted the "Conference of Certification Organizations" (Konfernz der Kontrollstellen e.V., abbreviated KdK) and Organic Agriculture Research Institute (Forschungsinstitut für biologischen Landbau, abbreviated FiBL) (Weber et al., 2002) with formulating certification personnel qualification requirements on the basis of the EU Organic Regulation. That study found that supervision of certification personnel and approval procedures are very important.</p><p>Certification personnel requirements may include: </p><p>1. Occupational abilities: academic attainment, professional training, job experience </p><p>2. Professional abilities: certification ability in certification areas of responsibility</p><p>3. Language and communication skills</p><p>18 4. Personal qualities </p><p>5. Objectivity </p><p>6. Further education </p><p>7. Evaluations or examinations </p><p>Taiwan's Organic Agricultural Product Management Operating Guidelines are not at all thorough in specifying the qualifications of certification personnel. Although organic regulations explicitly state that certification personnel shall have passed training and examination administered by a training organization commissioned by the COA, this requirement has not yet been implemented. There are consequently no approval procedures for organic certification personnel in Taiwan, and there are no certification personnel and evaluation regulations. </p><p>Risk Management </p><p>Data Management </p><p>The EU Organic Regulation specifies that each country shall authorize one organization to receive data reported by operators, and that this organization must guarantee that it shall provide the most up-to-date lists of enterprises certified for interested parties, including the enterprises' names and addresses (EU Organic Regulation 8.2, 8.3). </p><p>The EU Organic Regulation (especially in Annex 3), Germany's Organic Law, and relevant rules specify the records that must be kept by certified enterprises, certification organizations, Länder government authorities, and the federal government authority, as well as items that must be reported by upper-level agencies. And beyond specifying items to be recorded and the obligation of recording parties to accept inspection, the foregoing laws and regulations also specify confidentiality and notification duties. </p><p>19 The goal of recording and reporting information is to ensure traceability of products throughout the entire production chain and ensure compliance with the requirements of laws and regulations. </p><p>While some certification organizations in Germany have internal data management systems, there are not yet any connections between the systems of different organizations, and the organizations do not allow external queries. In order to provide the public with information concerning certified enterprises, Germany's BMVEL provides an online list of certified organic enterprises (Internet-Verzeichnis kontrolliert Unternehmen des ökologischen</p><p>Landbaus; http: //www.bioc.info); the system currently includes organic operators approved by the national certification systems of Germany, Austria, and Luxembourg. Nine German certification organizations participate in this system; there is data on 9,885 certified organic enterprises, including farms, processing plants, and importers. </p><p>The primary goals of this system include: </p><p>1. Providing quick and convenient data queries </p><p>2. Safeguarding quality </p><p>3. Avoiding falsified data </p><p>4. Providing the most up-to-date information</p><p>Germany's Organic Logo Act governs the Organic Logo's usage, prohibition of use, authorization, punishments, fines, and revocation. The Organic Logo Format and Usage</p><p>Regulations contain five articles respectively governing the Organic Logo's format, usage</p><p>(permitted use of the logo on packaging or unpackaged products, in advertising, and by the science), application for use, violations, and implementation. While the Organic Logo Format and Usage Regulations specify that use of the logo is free and not compulsory, those persons</p><p>20 to wish to use the Organic Logo must register with the organic logo information center of the</p><p>Organic Logo Company (die Informationsstelle Bio-Siegel bei der Öko-Prüfzeichen GmbH) commissioned by the BMVEL before they may print the logo on product packaging. A total of</p><p>29,466 products from 1,410 enterprises had been registered as of August 30, 2005. The goal of Organic Logo registration is to understand the state of Organic Logo usage and avoid illicit use of the logo. Registration is therefore a type of risk management. </p><p>To avoid the spread of bovine spongiform encephalopathy (mad cow disease), the</p><p>European Union instituted a tracking system for cattle and beef on January 1, 1998. Under the system, cattle are given identical markings on both ears to express their serial numbers.</p><p>Barcodes may also be hung on the animals' ears. Each animal has a passport recording its data births, sex, variety, and mother's ear number. Each animal is also assigned a slaughter number when it is slaughtered. The slaughter numbers and cattle numbers are recorded at a data center. All livestock have been required to be registered in the "Livestock Source Safety and</p><p>Information System"3 (Herkunftssicherungs- und Informationssystem für Tiere, abbreviated</p><p>HIT) since September 26, 1999. Registration methods include use of paper registration forms, phone registration, and online registration. </p><p>Taiwan's Organic Agriculture Information Website established an "Organic Agriculture</p><p>Certification Management Information System" as early as 2001 in accordance with Point</p><p>10.6 of Taiwan's Organic Agricultural Product Management Operating Guidelines concerning</p><p>"real-time updating of relevant certification data management system data." Certification organizations had input data for 820 farms as of August 2005; this number is not far from</p><p>Taiwan's current total of 866 certified organic farms. However, since the government stopped requesting data from certification organizations after organic certification management duties</p><p>3 http://www.hi-tier.de/</p><p>21 were transferred from the Agricultural Production Section of the COA to the Agriculture and</p><p>Food Agency in 2003, the data in the foregoing system is incomplete. While the Agriculture and Food Agency's Agricultural Materials Section has recently realized the importance of a data management system, and designed a certification management system in 2005, the COA</p><p>Information Section has somewhat inexplicably established its own internal certification organization information management system. The overlap between the two certification data management systems will only complicate future integration efforts. </p><p>Whether or not Taiwan's certification management information system is successful, and whether or not its data is correct, up-to-date, and continuous, will depend on the amount of importance attached to it by government, and government's determination to request correct, up-to-date data from certification organizations. </p><p>A.Quality Monitoring </p><p>Certification of enterprises is an important mechanism for protecting the quality and safety of organic products. Certification primarily consists of enterprise inspection, document inspection, and, when necessary, chemical analysis of specimens. </p><p>However, third party monitoring is still needed to test or prove that products meet requirements. The goal of quality monitoring is to verify product quality to consumers while also lessening the occurrence of fraud or violations. </p><p>Although Germany has not established a special monitoring system for organic products,</p><p>Länder governments monitor organic products via general food quality monitoring systems and processes required by law. </p><p>The state of Baden-Wurttemberg began implementing a five-year continuous organic product quality monitoring program in June 2001, and issued research reports resulting from this program in 2002, 2003, and 2004. The primary intent of this program is to gain a better</p><p>22 understanding of consumers' disappointments with organic products in this expanding market niche, and increase consumers' confidence in the quality of organic foods (Chemisches und</p><p>Veterinäruntersuchungsamt Stuttgart., 2003). The program's content includes: </p><p>1. Determining the state of pesticide residues and contaminants in organic foods. </p><p>2. Comparing domestic and foreign organic products. </p><p>3. Investigating the improper marking of organic foods.</p><p>4. Comparing organic and general everyday foods. </p><p>Monitoring items include: </p><p>1. Genetic modification of crop products</p><p>2. Radiation exposure</p><p>3. Mycotoxin </p><p>4. Antibiotics in honey</p><p>5. Nitrate content </p><p>6. Organic chlorine and organic bromine contamination of animal products</p><p>7. Dioxin</p><p>8. Pesticide residues in crop products</p><p>9. Ochratoxin A and copper in alcoholic beverages</p><p>Apart from government monitoring of the quality of foods (including organic foods), private enterprises also perform internal quality monitoring of their products. Furthermore,</p><p>Germany's federal Natural Foods and Natural Products Association (Bundesverbänds</p><p>Naturkost Naturwaren, abbreviated BNN) began an organic vegetable and fruit monitoring program in 2003. Under this program, 250 pesticide residue tests were performed on 475 samples of organic fruits and vegetables taken from wholesale and retail stores in 2003. A total of 28 wholesalers and importers participate in this program. The program's primary goal</p><p>23 is to ensure that the quality of organic products purchased by participants and sold by their subordinate retail stores (chain stores) meets expectations. </p><p>As for the monitoring of organic product quality in Taiwan, the Agricultural Materials</p><p>Section of the Agriculture and Food Agency is responsible for monitoring the quality of non- rice crops, while the Food Production Section of the Agriculture and Food Agency is responsible for monitoring rice quality. The former announces quality monitoring results on a monthly basis on the Organic Agriculture Information Website. Monitoring items chiefly consist of pesticide residues and the regulation requirement of no detectable pesticide residues. Samples are taken from fields and from store shelves. Tested samples include both certified organic products and uncertified but claimed organic products. Regardless of whether samples meet or fails to meet requirements, all announced data includes the producer's name, certification organization, and amount of pesticide residues4. The brand and store are also announced when a tested sample is an on-the-shelf product. Quality monitoring has been implemented for 16 months to date, and has yielded the results shown in . The data indicates that products from producers certified by a COA-approved certification organization have significantly lower levels of pesticide residues than other products. Furthermore, the number of cases of pesticide residues failing to meet requirements this year have dropped significantly relative to last year (2004). </p><p>Table 2 Taiwan Organic Agricultural Product Quality Monitoring Results *</p><p>4 The Agriculture Chemicals and Toxic Substances Research Institute, COA tested organic products for a total of 165 pesticide residue items as of August 2005.</p><p>24 COA-approved Other certification organization Marked as Y/M Item cert ification organizat ion T ot al organic Samples wit h no detected MOA T OP A T OAF Subtotal COAA FOA Subtotal residues 109 115 58 282 38 15 53 44 379 Samples wit h detect ed residues 2 10 0 12 3 0 3 6 21 5/2004 T otal tested sam ples 111 125 58 294 41 15 56 50 400 ~12/2004 P ercentage containing Samplespesticide witresidues h no detected (%) 1.80 8.00 0.00 4.08 7.32 0.00 5.36 12.00 5.25 residues 135 86 71 292 38 15 53 35 380 Samples wit h detect ed residues 1 1 0 2 4 0 4 4 10 1/2005 T otal tested sam ples 136 87 71 294 42 15 57 39 390 ~ 8/2005 P ercentage containing pesticide residues (%) 0.74 1.15 0.00 0.68 9.52 0.00 7.02 10.26 2.56</p><p>* COA approved certification organizations: MOA – Mokichi Okada International Association, TOPA – Taiwan Organic Production Association, TOAF – Tse-Xin Organic Agricultural Foundation; other certification organizations: COAA – Chinese Organic Agribusiness Association (has applied to become a certification organization, but has not yet received COA approval), FOA: Taiwan Formosa Organic Association (approved by the COA on December 2005)</p><p>Risk-oriented Supervisory Actions</p><p>As explained above, in order to fully implement certification of organic agriculture, German Länder government authorities mutually supervise certification organizations via joint certification and follow-up certification. Each state sets its own ratio of joint certification and follow-up certification. However, in accordance with the Certification Organization Supervision Rules, the inspection of a certification organization's on-site work (i.e., joint certification and follow-up certification) should be risk-oriented and focused within a certain core range. For instance, (LÖK, 2004, p.8) inspection should focus on: 1. The proficiency, training, skills, and impartiality of certification personnel</p><p>2. Internal auditing and quality management results </p><p>3. Handling of complaint and appeal cases</p><p>4. Sanction of violations and handling of aftermath</p><p>5. Actual routine approval operations</p><p>6. Examination of enterprise documents </p><p>7. Determination of whether the certification unit employs risk-oriented certification</p><p> procedures </p><p>25 state's Bureau of Food and Hunting in North Rhine-Westphalia (Nordrhein-Westfalen,</p><p>NRW) (Das Landesamt für Ernährungswirtschaft und Jagd, abbreviated LEJ) is the state' s organic industry management authority. LEJ has set a joint and follow-up certification ratio of</p><p>5%. LEJ feels that this 5% should not be spread evenly across all certification organizations, and also should not be allocated according to the number of certified enterprises under each certification organization, but should rather be allocated in accordance with risk. Table 3 explains the risk factors and weighting used by LEJ; Taiwan can learn from this approach.</p><p>LEJ uses a risk calculation formula to determine how the 5% of organic enterprises should be allocated among certification organizations when performing joint or follow-up certification. </p><p>As for the selection of farms for joint or follow-up certification, a risk-oriented outlook is used to select the following enterprises: </p><p>1. Enterprises that have changed certification organizations </p><p>2. Newly-certified enterprises </p><p>3. Enterprises that simultaneously handle both organic and ordinary products</p><p>4. Enterprises with extraordinary approval </p><p>26 Table 3 Certification Risk Factors </p><p>Factor Weight Explanation Number of certified enterprises 3 The more certifications the greater the risk. Ratio of personnel with a low 2 The fewer the certifications, the less certification number of certifications ability and quality. Ratio of personnel with a high 1 The higher the number of certifications, the greater number of certifications the risk of oversights or incomplete certification. Ratio of new certification 3 Due to insufficient experience, new personnel are personnel more prone to errors and uncertainties. Certification organization 3 Score from LEJ's joint certification and follow-up supervision results certification evaluation during the previous year. Source: LÖK. 2004. </p><p>Furthermore, Germany's BMVEL commissioned a resource protection company</p><p>(Gesellschaft für Ressourcenschutz mbH) (2003) to perform a research project aimed at finding the certification system's weaknesses and risk factors (this project issued the research report "Analyse der Schwachstellen in der Kontrolle nach EU-Verordnung 2092/91 und</p><p>Erarbeitung von Vorschlägen zur Weiterentwicklung der Zertifizierungs- und Kontrollsysteme im Bereich des Öklogischen Landbaus"). The project examined possible risk during all stages from production to the consumer, including agricultural production, processing, shipment, sale, import, and retail. After analyzing the sources of product risk, the project submitted recommendations concerning how the certification system can reduce risk. </p><p>Since the government of Taiwan has no mechanisms for supervising certification organizations, certification personnel, and certified enterprises, it has no risk-oriented supervision similar to that of Germany. Taiwan still has some distance to go before it can analyze risk during the movement of organic products from producers to consumers. </p><p>27 Crisis Handling </p><p>Although Germany has sound certification mechanisms, this certainly doesn't mean that the country has never had any violations of regulations or substandard products appearing on the market. </p><p>If a private certification agency or Länder government authority discovers that a certified enterprise has committed a violation, and if the circumstances are not severe, the certification agency may handle the matter in accordance with its internal rules and contract with the enterprise. If an enterprise or certification organization commits severe violation of the EU</p><p>Organic Regulation, the state authority shall handle the matter, and may impose a maximum punishment of one year imprisonment in accordance with the Organic Agriculture Law. The maximum punishment for failure to fill out or submit records in a timely manner is a fine of</p><p>30,000 euros, however. </p><p>But regardless of the severity of a violation, whenever food or animal feed causes a threat to human health, necessary notification must be performed in accordance with the regulations of Chapter 4 "Rapid Warning System" of European Union 178/2002 Regulation</p><p>(EC) No 178/2002 "Laying down the General Principles and Requirements of Food Law,</p><p>Establishing the European Food Safety Authority and Laying down Procedures in Matters of</p><p>Food Safety" (EEC, 2002). The German standard information system (Standardisiertes</p><p>Informationssystem in Deutschland) prescribes that completed notification forms must state the notifying organization, the organization being notified, the product, the source, the violation, the handling situation, and other information. </p><p>Taiwan has no early warning system for foods. Although the Agriculture and Food</p><p>Agency monitors the quality of organic products, it is not the agency responsible for food sanitation. Since there are no laws governing organic products, any product can claim to be an</p><p>28 organic product. However, if any agency – regardless of whether a food management unit or the Agriculture and Food Agency – detects pesticide residues in an organic product on the market or sample taken at an organic farm, then a violation of the Organic Agricultural</p><p>Product Management Operating Guidelines has occurred. The certification organization will generally attempt to find out the reason for the pesticide residues; if the reason is the use of pesticides, then the producer's organic status is revoked. If the producer did not intentionally use pesticides, however, and the residues are due to contamination or contamination of production materials, then the product shall be temporarily prohibited from being sold as an organic product. </p><p>But no matter what the circumstances, the government can only deal with organic agricultural products in which pesticide residues have been detected in accordance with the</p><p>Department of Health Food Sanitation Management Act's "Permissible Residual Pesticide</p><p>Standards." The producers or sellers are not punished if no prohibited pesticides are detected, or if the concentration of pesticide residues does not exceed the permissible standard. A case is turned over to the county or city government for legal action only when there has been a violation of the Food Sanitation Management Act. </p><p>Taiwan has no Organic Agriculture Law, and therefore cannot fine or punish violations of organic regulations. This lack of management is destined to disappoint consumers whenever a crisis occurs, and is the most serious shortcoming of Taiwan's organic agriculture management system. </p><p>Conclusions </p><p>Because consumers feel that organic products can ensure the safety of their food, the public strongly hopes that government can adequately manage the quality of organic products.</p><p>The EU Organic Regulation and Germany's Organic Agriculture Law provide very clear</p><p>29 guidelines concerning the organic supervision system. Moreover, Germany's Private</p><p>Certification Organization Approval Procedure Rules and Certification Organization</p><p>Supervision Rules provide further regulations governing certification organizations. </p><p>Taiwan's certification system lacks any regulations governing the supervision of certification organizations and approval and supervision of certification personnel; this shortcoming urgently requires corrective action. It is now up to the government to implement two requirements stated in the current organic regulations: Certification personnel must be required to receive professional training and pass an examination; certification organizations must be required to update the data in the Certification Data Management Systems. </p><p>The government of Taiwan delegates the management of organic agriculture to three departments, which makes it impossible to unify duties and powers. In addition, the absence of local (city or county) government in the management system weakens supervision. These facts are certainly worthy of review and discussion. </p><p>Taiwan performs monthly monitoring of organic products and announces the results of monitoring. This action has significantly reduced the pesticide residue detection rate, and also exerted a deterrent effect on unscrupulous producers and sellers who might try to sell substandard products. Germany has no nationwide, specific organic product quality monitoring program, but the state of Baden-Würtenburg tests organic products for many substances of concern to consumers, such as nitrates, dioxin, and mycotoxin; Taiwan should consider emulating this approach. </p><p>As far as risk management is concerned, Germany's Certification Organization</p><p>Supervision Rules require that Länder governments perform on-site inspections of certification organizations' certification work. Joint certification and follow-up certification are risk-oriented, and certification organizations are required to employ risk-oriented</p><p>30 certification procedures. Taiwan's government and certification organizations should emulate these aspects. </p><p>Taiwan's organic agriculture certification system is gradually achieving a state of maturity after many years of hard work. Moreover, certification organizations and the certification logo are gradually winning consumers' confidence. Nevertheless, the lack of relevant management laws and punitive sanctions has left uncertified domestic and imported organic foods outside the scope of government regulation. This has tarnished the dedication and achievements of government and certification organizations. As a consequence, it is urgent that the government enact laws governing organic agriculture and imported organic products in order to protect the rights and interests of both producers and consumers. </p><p>Reference Council of Agriculture, Organic Agriculture Regulations, 2004. BLE. 2003. Leitlinien zum Zulassungsverfahren der privaten Kontrollstellen. BMVEL. 2001. Gesetz zur Einführung und Verwendung eines Kennzeichens für Erzeugnisse des ökologischen Landbaus. BMVEL. 2002a. Gesetz zum ökologischen landbau, BMVEL. 2002b. Verordnung zur Gestltung und Verwendung des Öko-Kennzeichens. BNN Herstellung und Handel e.V. 2004, Bestnoten für Obst und Gemüse aus Bioanbau. Chemisches und Veterinäruntersuchungsamt Stuttgart. 2003. Ökomonitoring 2003. EEC. 2002. Regulation (EC) No 178/2002. Laying down the General Principles and Requirements of Food Law, Establishing the European Food Safety Authority and Laying down Procedures in Matters of Food Safety. EEC. 2004. Council Regulation (EEC) No 2092/91 on Organic Production of Agricultural Products and Indications Referring thereto on Agricultural Products and Foodstuffs. Gesellschaft für Ressourcenschutz mbH. 2003. Analyse der Schawchestellen in der Kontrolle nach EU-Verordnung 2092/91 und Erarbeitung von Vorschlägen zur Weiterentwicklung</p><p>31 der Zertifizierungs- und Kontrollsysteme im Bereich des Ökologischen Landbaus. BMVEL. LÖK. 2004. Leitlinien zur Überwachung der Kontrollstellen. Neuendorff, Jochen. 2003. „Kennzeichnung und Kontrolle“. EG-Verordnung Ökolandbau - Eine einführende Erläuterung mit Beispielen. Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbaucherschutz des Landes Nordrhein-Westfalen. SÖL. 2004. Anteil der verbandsgebundenen Betriebe an den gesamten Öko-Betriebeb, http: //www.soel.de. Weber, Helmut, Jochen Neundorff, Julia Meier, Rolf Mäder, and Beate Huber. 2002. Entwicklung eines Anforderungsprofils für Kontrolluere im Rahmen des Kontrollsystems nach der EU-Verordnung 2092/91. BMVEL.</p><p>32</p>