, United States Food Safety liTashington.D.C'. a Department of and Inspection 20250 Agriculture Sen ice Dr. Antje Jaensch Deputy Head of L'nit Unit I06 Federal Office of Consumer Protection and Food Safety Diedersdorfer Weg 1 12277 Berlin - Mariendorf Gern~any Dear Dr. Jaensch: The Food Safety and Inspection Service (FSIS) conducted an on-site audit of the Gern~anmeat il:spectior, syster,: from Nover;.,ber 24 thrOUgE,December 20, 2005. EEclosed is 3 Of tile final audit report. Comments from Germany to the draft final audit report were received in a letter dated April 19, 2006, which is included as an addendum to the final report. If you have any questions regarding the FSIS audit, please contact me at telephone (202) 720- 378 1. You may also reach me at my facsimile number (202) 690-4040 or e-mail address (sally.\\bite@ fsis.usda.gov). Sincerely, Saliy White Director Internatiot~alEquivalence Staff Office of International Affairs Enclosure FSIS Form 2630-916861 EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES Dr. Antje Jaensch cc: William Westman, Minister Counselor, US Embassy. Bonn Friedrich it'acker, Agricultural Counselor. Embassy of Germany Norval Francis, Minister Counselor, US Mission to the EU.Brussels Canice Nolan, EC Mission to the US, Washington. DC Scott Bleggi, FAS Area Ofticer Barbara Masters, Administrator, FSIS Linda Swacina, Executive Director, FSIA, 01'4 Karen Stuck, Assistant Administrator, OIA William James, Deputy Asst. Administrator, OIA Donald Smart, Director, Review Staff, OPEER Clark Danford, Director, IEPS, OIA Sally White, Director, IES, OIA Mary Stanley, Director, IID, OIA Barbara McNiff, Director, FSIS Codex Progranls Staff Gerald Zimstein, IES, OIA Amy Winton, State Department rnulltry File (Gern~anyFY 2006 .Anni.~al.At~dit) FINAL REPORT OF AN AUDIT CANED OUT IN GERMANY COVERING GERMANY'S MEAT INSPECTION SYSTEM I- ood Safety and Inspection Senice LTnitedStates Department of Agriculture TA4BLEOF CONTENTS I. TNTRODUCTION 2. OBJECTIVE OF THE AUDIT 3. PROTOCOL 4. LEGAL BASIS FOR THE AUDIT 5. SUMMARY OF PREVIOUS AUDITS 6. MAIN FINDINGS 6.1 Legislation 6.2 Government Oversight 6.3 Headquarters Audit 8. LABORATORY AUDITS 9. SANITATION CONTROLS 9.1 Sanitation Standard Operating Procedures 9.2 Sanitation Performance Standards 9.3 EC Directive 641433 10. ANIMAL DISEASE CONTROLS 11. SLAUGHTERPROCESSING CONTROLS 11.1 Humane Handling and Slaughter i i .2 HACCP inlpiemenrarion 1 1.3 Testing for Generic Exherichla coli 11.4 Testing of Ready-to-Eat Products 11.5 EC Directive 641433 13. RESIDUE CONTROLS 12.1 FSIS Requirements 12.2 EC Directive 96/22 12.3 EC Directive 96,'23 ij ~WKCE~IEF~TCOL iKuLS 13 1 Dailq I~lspection 13 2 Testing for Suh?zonellu 13.3 Species Verification 13 1 hlonthl~Re\ s 13 5 Inspection Sl stem COII~Ic)l\ 14. CLOSIYG hlEETING 15. ATT,ACHMEKTS TO THE AUDIT REPORT ABBREI'IATIONS &ANDSPECLAL TERLlS LSED IK THE REPORT CCA Central Competent Authority (Bundesamt fur Verbraucherschutz und Lebensmittelsichereit. BVL-Federal Office of Consumer Protection and Food Safety) E. coli Escherichia coli FSIS Food Safety and Inspection Service LAVES Exporting Establishment Certifying Authority (Landesarnt fur Verbraucherschutz und Lebensmittelsicherheit, Lower Saxony State Office of Consumer Protection and Food Safety) Listeria nzo17ocytogenes Pathogen ReductiodHazard Analysis and Critical Control Point Systems Saimoneiia Saimoneiia species SPS Sanitation Performance Standards SSOP Sanitation Standard Operating Procedures VEA European ComrnunityIUnited States Veterinary Equivalence Agreement The audit took place in German! from Kovember 33 through December 20, 2005. An opening meeting was held on November 24, 2005, in Berlin with the Central Competent Authority (CCA). At this meeting, the auditor confirmed the objective and scope of the audit and discussed the auditor's itinefary. s. The auditor was accompanied during the entire audit by representatives from the CCA, the Federal Office of Consumer Protection and Food Safety andlor representatives from the state, district, and local inspection offices. 2. OBJECTIVES OF THE AUDIT This was a routine audit with two objectives. The first objective was to evaluate the performance of the CCA with respect to controls over the processing establishments certified by the CCA as eligible to export meat products to the United States. The second objective was to audit a cold storage establishment proposed for future certification by the I~~ZA. In pursuit of the objectives, the following sites were visited: the headquarters of the CCA ir, Berlin, two federal state inspection offices (one in the State of Bavaria in Munich and one in the state of Lower Saxony in Hannover), one Regional inspection office within the State of Bavaria in Ansbach, the offices of LAVES in Oldenburg, two district inspection offices (one in the State of Bavaria in Ansbach and one in the State of Lower Saxony in Westerstede), one government laboratory performing Listeria monocytogenes and Salmonella analysis on U.S.-destined product, one government laboratory performing residue analysis on U.S.-destined product. all five certified meat processing establishments, and one cold storage establishment proposed for future certification. Competent Authority Visits Comments Competent Authority Central I State 2 Regional 1 LAVES 1 District 2 1 Laboratories 12 1 1 Meat Processing Establishments 5 Cold Storage Establishment 1 This establishment was proposed for future I t I r~rtif;rstinn".,A L.II-UCIVII 3. PROTOCOL This on-site audit n.as conducted in four parts. One part in\.ol\~edvisits with CCA officials to discuss 01-ersight programs and practices. including enforcement acti\.ities. The second part im-011-edaudits of selected state: regional. district and local inspection offices responsible for 01ersight of establishments certified for export to the United States. The third part in\ olx ed on-site visits to five processing establishments and one cold storage establishment proposed for future certificatgn. The fourth part invol1 ed visits to tmo government laborato~.The Bal arian State'~aborato1~for Health and Food Safetl (LGL), located in Erlangen. was conducting analyses for the presence of Listeria vzonocytogenes and Salmoizella. The LAVES laboratory. located in Hannover, was conducting residue analj.sis on domestic product and export product destined for export to the United States. Program effectiveness determinations of Germany's inspection system focused on five areas of risk: (1) sanitation controls, including the implementation and operation of Sanitation Standard Operating Procedures, (2) animal disease controls, (3) processing controls, including the implementation and operation of HACCP programs, (4) residue controls, and (5) enforcement controls. Germany's inspection system was assessed by evaluating these five risk areas. During all on-site establishment visits, the auditor evaluated the nature, extent and degree to ~vhichfindings impacted on food safety and public health. The auditor also assessed Lo-?, ~GSD~&GZse;vicez are cz-ied czt by Germ2fiy nddeferxined ifestablishment and inspection system controls were in place to ensure the production of meat products that are safe, unadulterated and properly labeled. During the opening meeting, the auditor explained to the CCA that their inspection system would be audited in accordance with three areas of focus. First, under provisions of the European CommunityAJnited States Veterinary Equivalence Agreement (VEA), the FSIS auditor would audit the meat inspection system against European Commission Directive 64/43 3/EEC of June 1964; European Commission Directive 96/22/EC of April 1996; and European Commission Directive 96123iEC of April 1996. These directives have been declared equivalent under the VEA. Second. in areas not covered by these directives, the auditor would audit against FSIS requirements. These inciude daii] impcctiori in all certified esiablishments. the haqdling and disposal of inedible and condemned materials. and FSIS' requirements for HACCP and SSOP. Third, the auditor mjould audit against anj equi~ralencedeterminations that have been made by FSIS for German37 under provisions of the SanitaqiiPhj~osanitaryAgreement There are no equi\,alence determinations pertaining to Germany at this time. 4. LEGAL BASIS FOR 'THE AUDIT The audit mas undertahen under the specific pro1 isions of i'niid States Iiiii s and regulations. in particular. e The Federal Meat Inspection .4ct (21 [T.S.C. 601 et seq.) The Federal lleat Inspection Regulations (9 CFR Par-ts 301 to end), nlich include the Pathogen Reduction'HACCP regulations. In addition, compliance \\ it11 the follon ing European Community Directi~~es1%as also assessed: Council Directive 64/433/EEC, of June 1964, entitled "Health Problems Affecting Intra-Community Trade in Fresh Meat" Council Directive 96/23/EC. of 29 April 1996, entitled "Measures to Monitor Certain Substances and Residues Thereof in Live Animals and Animal Products" Council Directive 96/22/EC, of 29 April 1996, entitled "Prohibition on the Use in Stockfarming of Certain Substances Having a Hormonal or Thyrostatic Action and of B-agonists" 5, SUMMARY OF PREVIOUS AUDITS Final audit reports are available on FSIS' website at the following address: http:/luw.fsis.usda.gov/Regulations~&~Policies/Foreign~Audit~Reports/index.asp Mav 2004 Audit During the May 2004 FSIS audit of Germany's meat inqpection system. no deficiencies were reported. April 2005 Audit During the April 2005 FSIS audit of Gemlany's meat inspection system, the following