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Unlted States Food Safety Washington, D.C. Department of and Inspection Agriculture Senice

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Unlted States Food Safety Washington, D.C. Department of and nspection Agriculture Senice pu---p.. :wu Ms. Monique Eloit Chief Veterinary Officer Ministry of Agriculture 25 1 Rue de Vaugirard
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Unlted States Food Safety Washington, D.C. Department of and nspection Agriculture Senice pu---p.. :wu Ms. Monique Eloit Chief Veterinary Officer Ministry of Agriculture 25 1 Rue de Vaugirard Paris, Cedex 15, France 9 Dear Ms. Eloit: The Food Safety and nspection Service (FSS) conducted an on-site audit of France's meat and poultry inspection system on November 30 to December 2 1,2005. Comments from France have been included as an attachment to the final report. Enclosed is a copy of the final report. if you have any questions regardmg the bss aud~tor need addit~onal information, please contact me at telephone number (202) , at (202) or electronic mail at sal1y.n hite(l,fsis. - tlsda.gov. Sincerely, Sally white- Director nternational Equivalence Staff Office of nternational Affairs Enclosure FSS Form (6186) EQUAL OPPORTUNTY N EMPLOYMENT AND SERVCES Ms. Monique Eloit cc: Elizabeth Berry, Minister Counselor, US Embassy, Paris Christian Berger, Counselor for Agriculture, Embassy of France Canice Nolan, First Secretary, EU Mission to US, Washington, DC Nor~al Francis, Minister-Counselor, US Mission to the EU, Brussels Scott Bleggi, FAS Area Officer Robert Macke, Assistant Deputy Administrator, TP, FAS Barbara Masters, Administrator, FSS Karen Stuck, Assistant Administrator, OA William James, Deputy Asst. Administrator, OA Linda Swacina, Executive Director, FSA Donald Smart, Director, Program Review, OPEER Saiiy -W-hite, Director, ies Clark Danford, Director, EPS Mary Stanley, Director, D Barbara McNiff, Director, FSS Codex Programs Staff Amy Winton, State Department AJ Ogundipe, ES Country File FNAL FNAL REPORT OF AN AUDT CARRED OUT N FRANCE COVERNG FRANCE'S MEAT AND POULTRY NSPECTON SYSTEM NOVEMBER 30 THROUGH DECEMBER 2 1,2005 Food Safetj and nspection Service 'nitcd Statcs Department of Agriculture TABLE. OF CON TE?; TS 1. NTRODUCTON 2. OBJECTVE OF THE ACDT 3. PROTOCOL 4. LEGAL BASS FOR THE AUDT 5. SUMMARY OF PREVOUS AUDTS 6. MAN FNDNGS 6.1 Legislation 6.2 Government Oversight 6.3 Headquarters and Department Audits 7. ESTABLSHMENT AUDTS 8. RESDlJE AND MCROBOLOGY LABORATORY AUDTS 9. SANTATON CONTROLS 9.1 SSOP 9.2 EC Directive Other Sanitation requirements 10. ANMAL DSEASE CONTROLS 1 1. SLAUGHTERPROCESSNG CONTROLS Humane Handling and Slaughter HACCP mplementation Testing for Generic Escherichiu colr Testing of Ready-to Eat Products 11.5 EC Directive RESDUE CONTROLS 12.1 FSlS Requirements 12.2 EC Directive 96/ EC Directive 96/ ENFORCEMENT CONTROLS 13.1 Dailj nspection 13.2 Testing for Sdn1unc.111~ 13.3 Species Verification 13 4 Monthly Re\ iews 13.5 nspection Sj stem Controls 14. CLOSNG MEETNG AC hltn S 0 THL AllUlT REPOR ABBREVATONS.4ND SPECAL TERMS 17SEDY PHE RkPORT CCA CVO DGAL DDSV Central Competent ;\uthorit~cte~~eral Food Directorate Chief Veterinar~ Officer General Food Directorate Veterinary Ser\,ices E. coli Escherichiu coli FSS GVR QAM PRHACCP Salmonella SSOP VEA Food Safetg and nspection Scr\ ice nterregional nspectors General Quality Assurance Manager Pathogen Reduction 1 Hazard Analysis and Critical Control Point Symxis Snlnzonella species Sanitation Standard Operating Procedures European Communitj /United States Veterinary Equivalence Agreement ~ 1. NTRODUCTON The audit took place in France from No\ ember 30 through December An opening meeting mas held on No\eniber in Paris. France. nith the Central Competent Authority (CCA). At this meeting, the auditor confirmed the objective and scope of the audit. the auditor's itinerarq. and requested additional information needed to complete the audit of France's meat and poultrq inspection sqstcm The auditor was accompanied during the entire audit bq representati~ es from the CCA. the General Food Directorate, and/or representati\fes from the D&pcu^ten7e~f inspection offices. 2. OBJECTVE OF THE AUDT This audit was a routine annual audit. The objective of the audit Mas to evaluate the performance of the CCA with respect to controls over neat producing/storage establishn~ents certified by the CCA as eligible to export meat products to the United States. n pursuit of the objective, the following sites nerc \kited: the headquarters of the CCA. three Dipartement offices (DDSV), three laboratories. three slaughter establishments, and one processing establishment. 1 Competent Authority Visits Coniments J Competent Authority central- 1 Paris 1 Laboratories Dipurtenzerzt j Quimper w y - d Quimper / Vannes Cahors Slaughter Establishments 3 Pouldreuzic Processing Establishments 1 1 Sarlat PROTOCOL This on-site audit was conducted in four parts. One part in\ elk ed \ isits nith CCA officials to discuss oversight programs and practices. including enl'orcement activities. The second part involved an audit of a selection of records in the countrq 's inspection headquarters or Department offices. The third part in\ ol\ ed on-site sits to four establishments: thee slaughter establishments md one processing establishment. 7 he 'ourth part mcluded a isit to laboratories conducting anal4 4es of field samples for France's national residue control program. 'is ~cll a4 wme mlc~ob~ological sampling for generic Esc herzcllza coll (E cdr) and Suln~o~c.l/tr L Program effectiveness determinations of France's inspection sq stem focused on five areas of risk: (1) sanitation controls. including the implementation and operation of Sanitation Standard Operating Procedures (SSOP). (2) animal disease controls. (3 ) slaughter,'processing controls. including the implementation and operation of Hazard Analysis and Critical Control Point (HACCP) sq stems and a testing program for generic Escherichicr colr (E coli). (4) residue controls. and ( 5) enforcement controls. including a testing program for Sdnzonellu. France's inspection sq stem mas assessed bj evaluating these five risk areas. During all on-site establishment visits. the auditor e~aluated the nature, extent and degree to mhich findings impacted on food safetq and public health. The auditor also assessed how inspection services are carried out bq France and determined if establishment and inspection system controls were in place to ensure the production of meat and poultry products that are safe, unadulterated and properly labeled. At the opening meeting, the auditor explained to the C'CA that their inspection system would be audited in accordance with three areas of focus. First. under provisions of the European CommunityUnited States Veterinary Equi~ alence Agreement (VEA), the FSS auditor would audit the meat inspection system against European Conlmission Directive EEC of June 1964, European Com~nisslon Direct~vc Y612LEC oi April lyy6, and European Commission Directive 96/23/EC of April These directives have been declared equivalent under the VEA. Second, in areas not covered by these directives, the auditor would audit against FSS requirements. FSS requirements include dailq inspection in all certified establishments, humane handling and slaughter of animals. the handling and disposal of inedible and condemned materials. species verification testing. and requireinents for -ACCP. SSOP. and testing for generic E coli and Sa!rwne!lcr Third. the auditor would audit against anq equivalence detern~inations that have been made by FSS for France under provisions of the Agreement on the Application of Sanitary and Phytosanitary Measures. Currentlq. FSS has determined that three alternate procedures are equivalent to U.S. requirements: France uses S0 6579:2002 to analyze for S~rimorzeil~i. France suspends an establishment's eligibilit) to export the first time it fails to meet a S'uln1or~e11a performance standard until compliance v, ith this standard is met. FSS has now determined the use of Enterobacteriaceae and Total Viable Count in lieu of generic E coli is acceptable for all EL! exporting countries. Hen-ever, none of the establishments audited utili~e this equi~ alence determination. but continue to re14 on generic E coli as an indicator of process control. 4. LEGAL BtlSS FOR THE ADT The audit \\as undertaken under the spccific pro\ isions 01' regulations. in particular: lniteii States la1z.s and The Federal Meat nspection r4ct (21 L1.S.C. 601 et seq The Federal Meat nspection Regulations (9 CFR Parts 301 to end). nhich include the Pathogen ReductiodHACCP regulations. The Poultry Products nspection Act (21 U.S.C et seq.). and The Poultry Products nspection Regulations (9 CFR Past 381). n addition, conipliance with the following European Community Disectikes \vas also ~CCPPPPT~: L&d,,Ud U Council Directive lEEC of June 1964, entitled Health Problems Affecting ntra-community Trade in Fresh Meat. Council Directive 96/22/EC, of 29 April 1996, entitled Prohibition on the Use in Stockfarming of Certain Substances Having a Hornional or Thyrostatic Action and of B-agonists, and - Counci! Directi~~e iEC, gf 2'4 April 1996, entitled \/lras!.!re tn Mnnitnr Certain Substances and Residues Thereof in Live Animals and Animal Products. 5. SUMMARY OF PREVOUS AUDTS Final audit reports are available on FSS' u-ebsite at the following address: - Reports/index.asp The FSS audit of France's meat and poultry inspection system conducted in January of 2004 identitied the following deficiencies: The CCA did not have ultimate control and supervision over official activities of all employees and certified establishments. nspection personnel did not have su~licient hnouledge of the U.S. ACCP and SSOP regulatory requirements.. *. Defic!enc~es v,ere identified involvi!~g the fcl!!on ing 3rex of SSOP comp!iance: o Monitoring: specification of frequencies (one establishment) o mplementation of the SSOP (nine establishments) o Corrective actions: proper disposition of product (one establishment). o Recordkeeping: pre\ enti\ e measures for corrective actions mere not included in the daily records (nine establishments) SPS deficiencies, which could result in the creatlon of insanitarq conditions and product adulteration. were identified o Equipment and utensils (fi\ e establishments) o Ventilation (fia e establishments) o Maintenance of grounds facllit~es (three establishments) Noncompliances \\ it11 the follou ~ng regulator). requ~reme~its undel HACCP 1-s ere obser~ ed: o Completion of a supportable 11 ~~asd Znalj sls (6 establishments) o Verification acti\ ities (8 establishments) a o Monitoring (4 establishments) o Corrective Actions (5 establishn~ents) o Recordkeeping (5 establishments) o Reassessment (1 establishment) n two establishments, the reassessment of the HACCP plan did not properly address the hazards reasonably likely to occur associated ~vith Listeria monocpogenes. n one establishment. dailj. inspection \\as not prok~ided during the maturation process of fermented dry pork sausage. n two establishments, pre-operational sanitation Lvas not performed in a manner consistent with US expectations. At one estah!ishment. a carefill post-mortem examination and inspection was not made. During the course of this audit, three of 11 establishments nere delisted for failure to meet U.S. requirements and two of 11 establishments received a Notice of ntent to Delist (NOD). The subsequent FSS audit was an enforcement audit conducted in December of 2004, during which the following deficiencies were identified: a a n one establishment, ventilation adequate to control condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions was not provided. n one establishment, the intended use or the consumers of the finished product were not included in their writtcn HACCP plan. 6. MAN FNDNGS 6.1 Legislation The auditor was informed that the relevant EC Directi~ es. determined equivalent under the VEA, had been transposed into France's legislation. 6.2 Government Oversight CCA Control Systems The food safety system in France is based on collaboration among three independent ministries: the Ministry of Agriculture, Food. Fishery and Rural Affairs; the Ministry of Trade and Commerce; and the Ministrq of Public ealth. This inter-ministry working group is charged with coordinating and arbitrating the national position in the international community. The Ministrq of Agriculture. Food, Fishery and Rural Affairs serles as the lead component in this norking group. Further, the Diwction Genei.de de ',+lirncntution(dgal) is the lead agenc! nithln France for the de~ elopmcnt and implementation of food safet) polic!. The DGAL is based upon a single chain of command ~liith direction being given to each individual &pirrterwnt from the Headquarters in Paris. n the DG.4L created a new position. rc!j$rent tecl~niqzre nutiorxi1 (hereafter referred to as a national technical expert). with the role to o.ersee all establishments that are eligible to export products to the United States. The national technical expert brings technical support to the French inspectors. supervisors and coordinators in an advisor!- role. The CCA also created a second-tier o\ ersight position in addition to the abo\ e-mentioned national technical expert. The official in this position reports directly to the Chief Veterinary Officer (CVO). and the duties of this position include carrying out field audits. training of inspection personnel, and preparing reports for the CVO uith recommendations. The key difference between these tuo positions is the le\.el at ~ hich they interact within the national inspection system. The national technical expert uorks directlj with the establishments. The new oversight position uorks mith the DDSV to ensure that all FSS requirements are being properly implemented and verified. During this FSS audit. further clarifications mere pro~ided by the DGAL concerning the frequency at which these second-tier audits are performed. This can be summarized as l-ollows: 1. Second-tier audits are perf'ormed prior to listing an establishment as certified for U.S. export. 2. Concerning establishments which are already certified for U.S. export, second-tier audits are performed nit11 a target frequencj of at least once per year. 3. Second-tier audits can be conducted at the request of the DDSV overseeing a particular establishment on an as needed basis. Additionally. the following observations \\ere noted concerning the actual effectuation of this position: The extent and nature of the noncompliances identified during this FSS audit may be indicative of deficiencies in either the frequency or the manner in which these second-tier reviews are performed. especially with regard to newly-listed establishments. a While this position is described as ansnering directly to the CVO, audits perfor~ned at the request of the associated DDSV are done at their expense (i.e.. related tra1,el and lodging expenses are cok ered by the DDSV's budget). Although provisions exist uhich allom the DDSV to procure additional funding for these expenses, this additional step is not entirely consistent uith the concept of a direct line of command betnee11 thc CVO and this position. a One of the establishments 1 isited undernent onl~ an off-site document audit in the previous 1 ear. rhis type of audit differs from the field audit specified in this position's job dercription. At the regional lelrel. France is di\ ided in~o 97 repons lhere are tno groups that nark at the regional le\ el for the DGXL. The first asi' thc Qudit).\ssurance Managers (QAM). The QAMs are assigned nit11 the implementation of S \\ithi11 the DGAL. n performing this function. the Q.4Ms pro\ ide regional support to various diprrr-tmzerzts in an effort to harmonize the application of LJS import requirements. 1he second group is comprised of nine nterregional nspectors General (GVRs). each of whom oversees ses,eral of the 22 Regions fimctioning as one of the kej components of the organization's internal audit sj stem. A monthlq coordination meeting between the GVRs and the DGAL Director General is held in Paris. The GVRs also organize meetings with the DDSVs in their assigned regions nith the primarq purpose of ensuring the appropriate allocation of funds and staffing. t the local level. France's twentl -trio regions are further divided into 96 dkprrrten1ent.1 (there are also an additional 4 overseas diprir-renwnts). Each has a Director of Veterinary Services (Directeur dzl Dipcrrtementule S~Y'C~~ T 'eterzncrires, or DDSV). Each of these government employees holds a veterinarj degree, and is a sworn-in officer (as are all inspection staff); hislher testimonies have h~gh Lalue in court proceedings. Each Director has at least two deputies who are assigned to either the division of animal health and ~zelfareor the section addressing food safet]. The latter coordinates the inspection programs within the dipartement regarding all the approved meat and poultry slaughter and processing establishments therein. According to the volume of activity within the deparlement, the deputy has other coiieagues milo work wi~hirn~her a d repor3 lo himlher; these make up the Food Safety Service within the clkpcrriement These are either 1 eterinary officers or technical assistants with specific public health training. Larger L1ipartenzerzt,s.are divided into districts, each of which is under the supervision of a Veterinary Officer Ultimate Control and Supervision DGAL headquarters in Paris has the ultimate control and supervision of France's meat and poultry inspection system and has the authority to add or remove establishments from the list of establishments certified to export to the U.S., or to refuse the issuance of l~eterinary health certificates in order to prohibit exports from taking place. New official inspection guidelines are issued by DGAL headquarters in Paris. These guidelines are provided by facsimile. . and mtranet to the Directors of the 17kparremenw and, ihroug1l ilieai, to the field persofifid aid, if appropriate. also to establishment andlor laboratory management officials. Under the current system. it is the responsibility of these Directors to delegate implementation instructions to the appropriate officials under their super\ ision. and to ensure their implementation. he preponderance of information issued bj the DGAL, to the field is contained in a document referred to as the MEGAREG ,? hich is regularly updated and consolidates elements of the follouing FSS requirements into one location: 1. Sanitation 2. iaccp 3. Generic E coll sampling 4. Sulmoncll~itesting 5 Testing for Li5rercu mom)^.^ fohymj\ The following obser\ztions result from the re~ieii. of this document and should be considered in association with other findings identified during the audit process: The section concerning hygiene synonymously equates sanitation with SSOP. This differs from the FSS regulations outlined in 9 CFR 4 16, under which sanitation is divided into SPS and SSOP components. This document contains \.cry few regulatory references to 9 CFR. and may need to be more specifically tailored to these specific FSS regulations rather than providing an overview of FSS requirernents. A significant portion of the inspection personnel encountered during the audit rely almost esclusively on its contents in order to perform their duties in enforcing FSS requirements. Overall, there mas little familiarity among inspection personne! with regi~lations contained outside of 9 CFR 41 6, 41 7: and with those addressing microbial sampling Assignment of Competent, Qualified nspectors No full- or part-time DGAL employees are permitted to perfom any private, establishment-paid tasks at an establishment in which they perform official duties. As the majority of noncompliances encountered during the audit involved a newly listed establishment, the DGAL needs to continue to ensure that knouledge of the FSS inspection requirements, including HACCP, SSOP, and of the other regulations found in 9 CFR is consistent throughout of its inspection force Authority and Responsibility to Enforce the Laws DGAL has the authority and the responsibility to enforce all J.S. requireme
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