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Republic of San Marino - 2001

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Republic of San Marino - 2001 Powered By Docstoc
					United States Department of Agriculture

Food Safety and Inspection Service

Washington, D.C. 20250

9

'

Mr. Dario Galassi Counselor Dipartimento Affari Esteri Direzione Degli Affari Economici E Sociali Palazzo Begni Republic of San Marino (47031) Via Italy Dear Mr. Galassi: The Food Safety and Inspection Service has completed an initial equivalence on-site audit of San Marino's meat inspection system. The audit was conducted from April 29 to May 4, 2001. Enclosed is a copy of the final audit report. Comments from San Marino have been included as Attachment B. For your information, the next step in FSIS' initial equivalence process is to publish a proposed rule in the Federal Re%isterproposing to add San Marino as eligible to export meat products to the United States. The public will be given 60 days from the date of publication to submit comments on the proposal. After a review of the comments received, FSIS will publish a final rule in the Federal Register to add San Marino to the list of countries eligible to export meat products to the United States (9 CFR 327.2). We will then notify you of the publication date of the final rule. At that time, San Marino can certify eligible establishments for export to the United States. If you have any questions regarding the audit or need additional information, please contact me at 202-720-3781. My fax number is 202-690-4040 and my email address is sall ystratmoen Ofsis.usda.gov.

Sincerely,

IS/ Sally Stratrnoen
/ / Chief, Equivalence

International Policy Staff Office of Policy, Program Development and Evaluation Enclosure

Mr. Dario Galassi cc: Lisa Hardy Bass, Counselor, U.S. Embassy, Rome Ron Hicks, Acting Associate Administrator, FSIS Ma~itza Colon-Pullano, SAWS, OPPDE John Wilson, FAS Area Officer John Prucha, ADA, OPPDE Sally Stratmoen, Chief, Equivalence, IPS, OPPDE Karen Stuck, Chief, IEPS, IPS, OPPDE Donald Smart, Director, Review Staff, O F 0 Amy Winton, State Department Nancy Goodwin, EPS, IPS, OPPDE Country File (San Marino-initial equivalence-final audit report)

FSIS:OPPDE:IPS:EB:NGoodwin:bw:4/4/02:720-9187:4/2/02:San Marino-final audit

initial equiv.

- 7
Background

USDAf::p::;:: ;:
Agriculture

Food Safety And Inspection Service

Technical Service Center

Suite 300, Landmark Center 1299 Farnam Street Omaha, NE 68102

FINAL

AUDIT REPORT INITIAL EQC'IVALENCE DETERMINATION FOR SAX NIARINO APRIL 29,200 1 THROUGH MAY 4 , 2 0 0 1
INTRODUCTION

San Marino is a small country located in Southern Europe, and is surrounded by the country of Italy on all sides. The country has a population of approximately 26,527 and is approximately 64 square kilometers in size. The capital city is San Marino. San Marino plans to export cooked ham to the United States. Pork carcasses will be imported from establishments located in countries already found to be equivalent by FSIS. Although San ~Marinohas one slaughter establishment and several processing establishments. only one processing establishment wishes to be certified to export to the United States at this time. This report reflects information that was obtained during an initial team review of San Marino's meat inspection system from April 39 through lMay 1, 1 as part of the process to determine 200 whether or not San Marino's meat inspection system was equivalent to the U.S. inspection system. Initial equivalence determinations are based on a three-part process as follows: (1 j FSIS conducts a document review of documentation submitted by the country in response to five questionnaires. The documents are reviewed by FSIS scientific and technical program experts to make appropriate equivalence determinations. The questionnaires and their responses cover the following five areas of risk: .Animal disease controls Residue controls Sanitation controls, including the implementation and operation of Sanitation Standard Operating Procedures (SSOP), Slaughter.' Processing controls, including the implementation and operation of Hazard Analysis and Critical Control Point (HACCP) systems and generic Escherichia coli (E. coli) testing, Enforcement controls, including the testing program for Snlmonelln species.
(3) Once FSIS has found that the country's documents demonstrate an equivalent inspection system. an audit team is sent to verify that the inspection requirements and procedures are effectively implemented.

13) If the country is found to be equivalent based on the document review and verified by an onsite audit, FSIS publishes a proposed rule in the Federal Register listing the country as digible to export meat, poultry andlor egg products to the United States. After a comment period. analysis of comments, and a final rule is published in the Federal Register, the country can certify establishments to export to the United States.

PROTOCOL
This on-site audit of San Marino was the second step in the initial equivalence determination process. The purpose of the audit was to determine if San Marino had implemented all of the procedures found to be equivalent by FSIS. To accomplish this goal, the auditors audited San ~Marino'sinspection system against the documents sent to FSIS for the document review stage of the initial equivalence process. The audit was conducted in three pans by a team of three experts. One part involved interviews with the representatives of the Environmental Health Service {EHS), and other governmental officials to discuss oversight programs and practices, including enforcement activities. The second was a visit to the national laboratory, which performs analytical testing of field samples for the presence of microbiological contamination. The third part was an on-site visit to the processing establishment. Entrance Meeting On April 29, 2001, an entrance meeting was held in the c ~ t y San _Marin0 at the offices of the of EHS. The attendees resolved ~tinerary issues, and generally clarified the structure and role of the EHS and the National Civil Police (CP). EHS representatives Dr. Carlo Antonelli, Director; Dr. Renaldo Ciro Renzi. Assistant Director; ,Mrs. Raffaella Sapigni, Chief. Chemical Laboratory; Dr. Maurizio Berardi, Chief, Veterinary Service; Dr. Maurizio Battistini, Medical Veterinarian; Ms. Rosaria Bacciocchi, Chief, Biological Laboratory; and Dr. Antonio Putti, lMedical Veterinarian attended. In addition, San Manno governmental representatives Mr. Gabriele Gattei, Vice Commandant, CP; Mr. Dario Galassi, Counselor, Ministry of Foreign Affairs; Ms. Laura Fabbri, Interpreter, Ministry of Foreign Affairs: and Ms. Marina Volpinari, Interpreter, ,Ministry of Foreign Affairs attended. FSIS audit team members Dr. Faizur Choudry, International Audit Staff, FSIS; Ms. Sally Stratmoen: Chief, Equivalence Section. International Policy Staft Office of Policy, Program Development and Evaluation: and Ms. Geraldine Ransom, Chief, Microbiology Branch, Biosciences Division, Office of Public Health and Science were present. Dunng the audit, the auditors ~ntervlewedrepresentatives of the EHS and the CP concernmg the organizational structure and upper levels of inspect~on staffing of San Manno's lnspectlon system and the enforcement of meat inspection health requirements. Auditors also rev~ewed the national laboratory that analyzes samples for Llsrerla moizocyrogenes and Salmonella from ready-to-eat products such as cooked ham. Results of this phase of the a u d ~ are summanzed t under the five nsk areas set forth later in t h ~ s report. In addition. the single estabhshment ;hat applied for cert~lication evport meat products to the United States was audlted. (See to .?ttacI?nzent .-l for results )

EQUAL CPPCRTUNITY IN EMPLOYMENT AND SERVICES

RESULTS AND DISCUSSION
.As mentioned above, the auditors audited San Marino's meat inspection system against the documents that were earlier submitted to FSIS and which demonstrated an equivalent system. The five risk areas and the auditors' findings are as follows.

ANIMAL DISEASE CONTROLS The team verified the implementation of equivalent animal disease controls. No animals from San Marino are slaughtered for use in products to be exported to the United States. San Marino imports pork carcasses from establishments in Italy that are certified to export to the United States. All animals in San Marino are registered with EHS. Any animals transported into San Marino are inspected by EHS veterinarians at the border and are registered. Processed products (cooked ham) meet USDA's Animal and Plant Health Inspection Service's (APHIS) requirements.

RESTDIUE CONTROLS
The team verified the implementation of equivalent residue controls. San Marino imports swine carcasses from certified establishments within countries that are eligible to export to the United States. Residue testing is conducted in the country that slaughters the swine. Italy's national residue control program is equivalent to the national residue progam of the United States. SANITATION CONTROLS The team verified the implementation of equivalent sanitation controls, including the implementation of SSOP. .Any sanitation concerns found during the audit of the establishment were minor and were corrected. SLAuGHTER/PROCESSIi\jG COKTROLS The team verified that the slaughteriprocessing controls were effectively implemented with the exception of the following:
( 1)

EHS modified the FSIS approved I S 0 Xnalytlcal Method for Sdrnonella and Llstena testing for ready-to-eat products w~thout FSIS equivalence determinat~on.The use of a an nonstandard unvalidated analytical method is not equivalent because it puts the laboratory at nsk for not detecting pathogens in the ready-to-eat product. EHS agreed to adopt the unmodified FSIS approved analytical method.

(2) EHS was not currently carrying out a general inspection review of the establishment including the establishment's HXCCP program. EHS agreed to set up procedures to conduct such reviews.

(3) EHS veterinarians were not trained on FSIS's pathogen reduction and HACCP requirements. For this reason they did not fully understand their role in verifying SSOP and HACCP implementation at the establishment.

C 2 V P L OPPCRTUNITY 1 E\lPLOYMEFIT AND SE?.'/lCES N

ENFORCEMENT CONTROLS The team verified that the enforcement controls were effectively implemented with the exception of the following: (1) EHS had not implemented off-hours checks of the establishment that will be certified to export to the United States. EHS agreed to make these checks part of the annual plan for investigations. (2) EHS was not monitoringverifying the adequacy and effectiveness to ensure that corrective actions were being taken under both SSOP and HACCP at the establishment. This deticiency was the result of inadequate training. EHS agreed to take appropriate actions in the future.
( 3 ) EHS had controls to prevent commingling of product in the establishment. However, in

anticipation of increased production, EHS needs to further tighten controls to prevent commingling of product destined for either other countries or domestic use with product to be ~xported the United States. EHS agreed to tighten controls. to

( )EHS did not have a procedure to monitor their products if products were refused entry 4
by the United States. EHS agreed to establish a monitoring system. (5j EHS conducts Listeria testing on ready-to-eat products including cooked hams. However, the team found several differences between FSIS' and EHS' testing procedures. FSIS takes action against the product on the first Listeria positive and takes ten follow-up samples for testing. San Marino takes action on the second Listeria positive and takes only five followup samples for testing. EHS agreed to adopt the FSIS requirements for Listeria testing of ready-to-eat products.

(6) EHS conducts Salmonella testing on ready-to-eat products including cooked hams. However, the laboratory had changed the analytic method without an equivalence decision by FSIS. EHS agreed to use a FSIS approved I S 0 analytical method.
(7) A11 inspectors in the establishment that will be certified by San Marino as eligible to export meat products to the LTnited States were full-time EHS employees, receiving no remuneration from either industry or establishment personnel. However, the frequency of inspections and the amount of time in the establishment were not adequate. '4 veterinary inspector was visiting the establishment twice a week for approximately one-hour during each visit. EHS agreed to provide daily continuous inspection coverage. Although willing to increase the frequency and time of inspection, EHS will have to acquire additional funding prior to certifying any additional establishments as meeting US requirements.

(8) EHS was not conducting monthly supervisory reviews in addition to regular inspection in the establishment. This was in part because of lack of understanding of the requirement.
Even w ~ t h above-mentioned areas of concern, speclal mentlon should be made about San the Manno's othenv~se excellent enforcement program. The EHS collaborates wlth the CP in both surveillance and enforcement of meat inspection requirements. Because of the small slze of the country, the EHS is able to uork in teams with the CP EHS annually prepares an enforcement plan based on nsk considering the nsks of the particular product and pnor v~olations.Meticulous

EQUAL CPPORTUNIW IN EMPLCIYMENT AND SERVICES

1

records including an automated track~ng system are malntalned b EHS to track investlgatlons ! and to plan for future enforcement. Appropriate sanctions are a.irailableto znforce their equivalent requirements. and the records evidences San AManno'sresolve to use them Exit Meeting The exit meeting was conducted at EHS headquarters on May 4,200 1. Counsellor Luca Brandi, Office of the Secretariat for Foreign Affairs was present. EHS representatives Dr. Carlo Antonelli, Director; Dr. Renaldo Ciro Renzi, Assistant Director; Mrs. Raffaella Sapigni, Chief, Chemical Laboratory; Dr. Maurizio Berardi, Chief, Veterinary Service; Dr. Maurizio Battistini, Medical Veterinarian; and Dr. Antonio Putti, Medical Veterinarian attended. In addition, San Marino governmental representatives Mr. Gabriele Gattei, Vice Commandant, CP; Mr. Dario Galassi, Counselor, Ministry of Foreign Affairs: IMS.Laura Fabbri, Interpreter, 1Ministr-y of Foreign Affairs; and Ms. Manna Volpinan, Interpreter, Ministry of Foreign Affairs attended. FSIS audit team members Dr. Faizur Choudry, Lead Auditor, International Audit Staff, FSIS; Ms. Sally Stratrnoen, Chief, Equivalence Section, International Policy StafC Office of Policy, and Program Development and Evaluat~on; Ms. Geraldine Ransom, Chief. Microbiology Branch, Biosciences Division, Office of Public Health and Science attended. The following topics were discussed:
1. The team's evaluation of the five risk areas: Animal Disease Controls: Residue Controls, Sanitation Controls, Slaughter~Processing Controls, and Enforcement Controls.

2. The on-site audit results of the establishment. (Please see Attachment A)
3 The next steps for approval to export meat products to the United States, mcluding taklng correctwe actlons as a result of this audit report; walt~ng FSIS rulemakmg; applicat~on for of APHIS requirements; and developing FSIS-approved export certificates.

CONCLUSION
The team verified that San Manno's meat inspection system was implemented in an equivalent manner with the exceptions noted above in the report. It is strongly recommended that at least two veterinary officials from EHS and a translator from San Marino attend FSIS' Foreign National Training in January or February 2002 to receive appropriate training in FSIS' requirements.

Nancy Goodwin Project Leader San Manno Inlt~al Equivalence Attachment A-Establishment Review Report

I

EQUAL OPPCRTUNITY IN EMPLOYMENT AND SERVICES

J s 3EPARThlENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE M T R N A T I O N A L PROGRAMS

1 REVIEW DATE ESTABLISHMENT NO. AND NAME
I

FOREIGN PLANT REVIEW FORM
NAME OF JEVIEWER Dr. Falz R. Chouary
CODES ( G i v e a n appropriate A = Acceptable

5/3/2001

1/30&

San ,Marmo Prosclunls S.X. 'Jia Del h v o r o : 45
E'/ALUATION
7
d

Esr. 2-L

1
1

Att A
2 h C C l O ~ O

San iManno
Unacceoraoie

COUNTRY

NAME OF =OREIGN OFFIC!AL Dr. .Maunzlo Ban~stim code ror eacn r e v i e w ifern llsred belowj M = Varg~nally Acceptable U = ;Jnacceptable Cross contarnlnatlon prevention
I
1

-

AxeuraDle

AcceDtable/ ae-revfew

N =
,

Vor Rev~ewed Formulations

0

= Does not aoolv

1. CONTAMINATION CONTROL

( a ) BASIC ESTABLISHMENT FAClLiTlES

Equipment Sanlrizlng

I

--9

I

I

A

Packaging materials

Water potability records Chlorination procedures Back slphonage preventron Hand washing facrlitles
1

1 Product handling and storage 1 Product reconditioning
03

/

'A O

A
1

Product transportation

/ '$ 1
:3

I Laboratory confirmation 1 Label approvals
Special label claims Inspector monitoring Processing schedules Processing equipment Processing records
/
i

I

i

56

.i

/

1

' 5
61

04

A

(dl ESTABLISHMENT SANITATION PROGRAM

Effectwe maintenance program Establishments separation Pest --no evidence Pest control program Pest control monltorlng Temperature control
08 39

I

(

I

C6

A

Preoperational sanitation Operational sanitation

1 34
i A j 35
A

:3

!

A

1 62

;

A .

1 63 1 . A
64

4

Weste disposal
2. DISEASE CONTROL

1

364

A
'0

A

Anlmal identlficatlon Antemortem rnspec. procedures

1 'b
I 3$
1

I

1 Empty can ~ n s o e c t l o n
Filling procedures

1 0

!

container closure exam
lnterlm container handling

1 73
0
1 67

O~erations work space Inspector w o r k space

'

2

A
'3

Antemortern dispositions Humane Slaughter Postmortem inspec. procedures

'90 ( Post-processing handling
Incubation procedures Process. defect actions -- plant Processing control

0

1' 8 I 'b
1'
iI rb

1

6?l
"

Facilities approval Equipment approval
, :6 I A

Postmortem dispositions Condemned product conrrol

-- inspection

1 'i
j: '

I 0

5. COMPLIANCUECON. FRAUD CONTROL

ib) CONDITION OF FACILITIES EQUIPMENT

Restricted product control
17

Export product identification Inspector verification Export c e r t ~ f i c a t e s

Over-product ceilings Over-product equlpment Product contact equlpment Other product areas (inside) Dry storage areas Antemortem facilities Welfare facilities Outside premises
ic) PRODUCT PROTECTION 3r HANDLING
I
I

1

1

.4
'8

Returned and rework product
3. RESIDUE CONTROL

4k

/ 'i
75

A
'9

A

Residue program compliance Sampling procedures 3es1due reporting procedures 4pproval of chemicals, etc. Storage and use of chemicals
4 . PROCESSED PRODL'CT CONTROL

/%
1 '70
I

Single standard lnspectlon supervision Control of securlty [terns

A

o :
2'

4
.C1

/'zr
1 7i

' 5

%
23

( Shipment security
'

.A
' : s .4

' 1 Species verification i
"Equal t o " s:a?us Imports

/

30

i

A

're-boning trrm
: 5 4

1
1

I 31

.A

Personal dress and habits

3oneless meat re1nspec:ion ngredients iaentification :%ai
of reslrlcrea ngredients
53

A

I
I

7 1 ;
O e s ~ g n e a 2 e r F O R M ?50 S o i r w a r e o v Delrtna an

3 - 2 ( 1 1 9 1 'WHICH M A Y 3E USED UNTIL EXHAUSTED. 10.

I

1 RE'/IEW DATE

1

FOREIGN PLANT R E M W FORM 1 (reverse)
Y A M € OF qE'fIEWE9
I

'I
I

1/30 & 5/3/2001

I
I

ESTABLISHMENT NO. AND NAME

/ CITY'

1 Gualdicc~olo
I San Marmo

Est. 2-L San M m n o Proscmnls S.A. Vla Del h v o r o : 45
EVALUATION
I
Acceorable

NAME OF FOREIGN OFFICIAL

Dr Falz R. Choudry
ZOMMENTS:

Dr .Maunzio Batnstm

-

Accepraolel Re,ewew

-

Unacceorable

07. Gaps at rhe bottoms o i door in the shippmg room were not sealed properly to prevent the entrance o t rodents and other vermln Corrected.
71. Deep cracks dong the wails and floors in the dry storage room. were not sealed properly to avoid harboring of insects, rodents ordered correction. and other vermin. Establishment offic~ais
T

26. Personal were not using hygienic work habits to prevent product contamination such as an employee was observed pickmg up dirty 'knife from the floor and, without washing his hands or washinglsanitizing his knife, handled edible product in the boning room. An other employee was observed handling trash container and, without washmg his hands, handled edible product in the processing room. Establishment oificiais took corrective actions immediately and preventive measures were proposed to GOSM inspection ofticials.
31 Edible product that contacted tDe ?loor (dropped meat) was not reconditioned in a sanitary. manner before beng added to the edibie product m h e bomng room. Establishment offic~als ordered correcnon.
43. Containers of edible and inedible product were not identified in the boning and processing room. Establishment officials ordered correction immediately.

76. a) Monthly supervisory visits were not performed by the GOSM officials. b) Governrnenr of San .Marin0 (GOSM) inspection officials were not providing daily continuous inspection coverage during the operation. Vererinaq inspecror was visiting establishment two times per week and one hour in each visit. EHS officials agreed to take corrective actions. '

~ ~ ' B B L t DI IS A N iMZLRW0 G

DIP.!LR~ME~\ITO XFFAIiI E5TER.I
3EEZIOhT DEGLI _IFFARI ECONOMIC: 2 SOC!lALI

San ,Marina, 11 March 2002 Ref. N2214MW7

S a y Stratmoen Acting Director Intemarional Policy Staff O e c e o f Policy, Program Development and Evaluation

Washington, D.C.

Dear Ms. Stratmom,

wirh reference to you lerter dated September 17,2001, I would like to M o m you that the d a f i audit report you sent us is acceptable by San Main0 as it is; there are no comrnenrs on our part.

There are o d y few corrections I need to point our, i che chaprer called PROTOCOL, page 2, in the n "Enmince ,MeedngMpart: 1) the name of the Chemical Laborarory cbieiis W a e l l a Sapigni; 2) the name of the vice commandant is Gabriele Gattei; 3 ) my ritle i Counsellor, -Mnishy of Foreign Mairs s
Best regards.

Dario Galassi Cousellor


				
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