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AGREEMENT IN THE FORM
OF AN EXCHANGE OF LETTERS
BETWEEN THE UNITED
STATES OF AMERICA
AND THE EUROPEAN
ECONOMIC COMMUNITY
CONCERNING THE
APPLICATION OF THE COMMUNITY THIRD COUNTRY DIRECTIVE,
COUNCIL DIRECTIVE
72/462/EEC,
AND THE CORRESPONDING
UNITED STATES OF AMERICA REGULATORY REQUIREMENTS
WITH RESPECT TO TRADE
IN FRESH BOVINE AND PORCINE MEAT
3. With particular reference to issue No. 26 in Annex I, concerning an alternative system for cold treatment of trichinae in pigmeat, the EC undertakes to have evaluated this issue not later than 31 January 1993.
4. Both Parties accept the desirability of following a mutually agreed approach.
In the context of the completion of the Single European Market, the US recognizes the need to apply uniform principles to the Member States of the Community.
5. Both Parties agree on the desirability of further co-operation with a view to harmonizing administrative actions. This would include frequency and timing of review visits in respect of the operation of their respective foreign veterinary inspection services responsible for reviewing third countries health systems and establishments wishing to export meat.
6. Both Parties accept the principle of regionalization for control of animal diseases. In this respect, both Parties accept the desirability of a mutually agreed approach to the application of such policies.
The US undertakes to continue the recognition of freedom of individual Member States from specified animal diseases, without the application of additional safeguards, after implementation of the single market strategy.
The US will undertake to amend its import policy regulations and legislation concerning FMD, rinderpest and other relevant diseases in the light of the concept of regionalization.
14. The two Parties agree to initiate discussions as soon as possible on other problems in the veterinary field in relation to trade in animals and products of animal origin. This includes, amongst other, monitoring of residues, poultrymeat, meat products and live animals.
I have the honour to propose that, if the foregoing is acceptable to your Government, this letter and your confirmatory reply shall together constitute and evidence an Agreement between the European Economic Community and the United States of America on the matter.
Please accept, Sir, the assurance of our highest consideration.
On behalf of the Council of the European Communities.
/s/Ray MacSherry
Sirs, Washington, 6 November 1992
I have the honour to acknowledge receipt of your letter of today's date which reads as follows:
"I refer to the Exchange of Letters of 7 May 1991 between the Commissions and the United States of America and the subsequent negotiations concerning the application of the Community Third Country Directive, Council Directive 72/462/EEC, and the corresponding United States of America regulatory requirements, with respect to trade in fresh bovine and porcine meat.
During the abovementioned negotiations, both Parties agreed to the following:
1. By the Exchange of Letters of 7 May 1991 the EC and US agreed to undertake a comparison of the EC Third Country Directive and the corresponding US Regulatory Requirements with the objective of determining whether EC and US requirements are equivalent. This process has been completed and has shown that both regulatory systems basically provide equivalent safeguards against public health risks.
2. The process of comparison identified some differences in legal and/or administrative requirements which, unless modified, preclude recognition of equivalence. Both Parties undertake to make the initiatives for the necessary modifications as soon as possible.
On issues which involve interpretation or implementation of legal and/or administrative requirements, both Parties undertake to apply actions on relevant issues in accordance with Annex I. With regard to these issues, both parties agree to complete implementation within six months of signing this Agreement.
3. With particular reference to issue No 26 in Annex I, concerning an alternative system for cold treatment of trichinae in pigmeat, the EC undertakes to have evaluated this issue not later than 31 January 1993.
4. Both Parties accept the desirability of following a mutually agreed approach.
In the context of the completion of the Single European Market, the US recognizes the need to apply uniform principles to the Member States of the Community.
13. Based on experience gained from operation of this Agreement, the EC will consider on the basis of mutual agreement, the possibility of approving plants certified by FSIS as being in compliance with EC requirements prior to visits by reviewers. The US already operates such a system.
14. The two Parties agree to initiate discussions as soon as possible on other problems in the veterinary field in relation to trade in animals and products of animal origin. This includes, amongst other, monitoring of residues, poultrymeat, meat products and live animals.
I have the honour to propose that, if the foregoing is acceptable to your Government, this letter and your confirmatory reply shall together constitute and evidence an Agreement between the European Economic Community and the United States of America on the matter."
I have the honour to confirm that my Government is in agreement with the contents of your letter.
Please accept, Sirs, the assurance of my highest consideration.
On behalf of the Government of the United States of America
/s/Carla Hills /s/Edward Madigan
11-13-92
ANNEX I
RECOMMENDED ACTIONS
1. Knocking (Stunning) Area
2. Antemortem (Facilities)
3. Antemortem (Facilities)
4. Antemortem (Inspection)
5. Antemortem (Inspection)
6. Sticking (Sterilization of Sticking Knife Between Cuts)
7. Sticking (Sterilization of Sticking Knife Between Carcasses)
8. Sticking (Provision of Apron Washing Cabinets for "Sticker")
9. Use of Drop Hoses
10. Livestock Trucks (Control of Washing Facilities)
11. Post Mortem Inspection (Identification & Correlation of Parts; Batch Condemnation)
12. Post Mortem Inspection (Procedures)
13. Personnel Requirements (Veterinary Oversight)
14. Personnel Requirements (Health Marks)
15. Personnel Requirements (Medical Certificates)
16. Personnel Requirements (Welfare Facilities)
17. Personnel Requirements (Clothing Use Restrictions)
18. Facilities (Dry Storage - Packaging Materials)
19. Facilities (Storage of Non-food Substances)
20. Facilities (Prohibition Against Wood Structures)
21. Facilities (Prohibition Against Wood Equipment)
22. Facilities (Potable Water - Frequency of Testing)
23. Facilities (Potable Water - Testing Methods)
24. Temperature Requirements (Products)
25. Temperature Requirements (Recording Devices)
26. Temperature Requirements (Destruction of Trichinae)
52. Administrative Actions (Submission of Written Monthly Reports)
53. Administrative Actions (Control of Transit Product)
54. Demands Made of EC Veterinary Services For Certification on Quality Matters
55. Residues
56. Administrative Actions (Requirements for Exporting Firm To Set Up A Financial Trust)
57. Transparency of Means For Recognizing That A Country Is Free From Disease
58. Recognition of Regional Health Status
59. The Acceptance of EC Sanitary Measures Applied Via Common Community Disease Management Decisions
60. Apparent Discrimination And Lack of Uniformity of US Authorities As Regards Recognition Of Different Member States' Disease Status
5. Veterinary to perform ante-mortem inspection
The problem concerns ante mortem veterinary inspection of animals at the slaughterhouse. US has proposed a solution which includes the following components:
- that EC requirements permit that inspection be carried out on the farm (feed lot)
- that US supply assurance that inspection is carried out at the feed lot by an accredited veterinary surgeon recognised by FSIS
- that the existing US systems as indicated in US documentation (Annex V-Subannex III in para III, subra 1 and 2 but not 3), will continue to be applied on arrival at the slaughterhouse.
Both sides should consider further actions necessary.
6. 7. 39. Sterilization of sticking knife between cuts and between carcasses
The inspector in charge of facilities approved for export to the EC shall take special care of the Community's concern for insuring that implements which have come in contact with the external surface of hides are cleaned before being used again on fresh meat.
Should be reflected in FSIS instructions. EC Instructions (VM) should reflect that any implements which have been in contact with the external surface of hide shall be cleaned before they are used again.
8. Apron washing cabinets for "sticker"
Withdrawn on the understanding that the preference for aprons to be washed in cabinets does not exclude use of flexible showers in accordance with Point 9.
See point 9.
11. Correlation of parts for post mortem inspection (batch condemnation)
Both sides agree on the need to correlate all offals with the carcass for the purpose of post mortem inspection. They also agree that if the blood or offal of several animals is collected in the same container before the completion of the post mortem inspection, the entire contents must be declared unfit for human consumption if the carcass of one of the animals concerned has been declared unfit for human consumption."
FSIS Instruction should reflect the need for the inspector in charge to demonstrate the effective operation of batch condemnation and correlation.
EC agrees to consider the US batching procedure as indicated in annexed schematic presentation as an acceptable batching procedure.
12 & 47. Post-mortem inspection procedures
Both sides indicated details of differences in specific post mortem inspection procedures for the different animal species. Exchange of documentation did not enable agreement to be reached. Both sides agree, however, that a joint review could lead to resolution of the matter.
Both sides agree on a joint evaluation of post-mortem inspection operations.
13 & 14. Veterinary control of cold stores, cutting, health marks and health labelling devices
The issues were examined on the basis of written documentation presented by the US concerning the organisation and responsibilities of the US inspection system.
These issues were addressed in relation to an enhanced role of the FSIS as regards exports to the EEC.
Adaptation of FSIS instructions in accordance with Annex III.
EC will consider further actions necessary including any necessary changes in its requirements.
15. Requirement for medical certificates on first employment
It is noted that the EC legislation gives the possibility of specific guarantees, which may be required regarding the medical supervision of staff working on, and handling, fresh meat.
The US legislation requires that no operator of an official establishment shall employ in any department where any product is handled or prepared any person showing evidence of a communicable disease in a transmissable stage (does not include a specific requirement for medical certificates).
The US will ensure that plant managements can demonstrate and document the way in which the US requirements are applied in practice. This information will be made available to the official inspector on request.
The follow up system of medical supervision and official enforcement will be in accordance with the documentation presented by the FSIS. The EC will examine whether the US follow up system gives adequate guarantees for EC requirements (on a case by case basis).
20. Structural wood
Both sides agree that the absolute EC prohibition of wood covers instruments and working equipment which might come into contact with fresh meat or offals. The US has presented a paper to support its proposal.
As regards the structural use of wood both sides agree that such structures must be in good condition impermeable, smooth durable, rot-proof and sealed with a coating that is waterproof. The EC will consider whether this can be considered an acceptable structural use of wood.
US proposed that the structural and overhead wooden beams (including beams in chillers and coolers) that have been impregnated with an approved compound (e.g. hot linseed oil) fulfill this requirement. The US will incorporate provisions in FSIS instructions to ensure effective control and hygenic maintenance of structural surfaces.
21. Wooden equipment
WITHDRAWN on grounds that it is not a major issue. The US agree that the use of wood in this area shall be phased out.
Any specific problems that arise should be addressed during plant review, it being understood that emergency maintenance equipment, such as ladders, may be used provided that there is no risk of contamination of fresh meat or offals.
22 & 23 Potable water (testing frequency and biological parameters).
It is noted that in accordance with Article 4(c) of EC directive 72/462 specific guarantees may be required concerning the quality of the potable water used by establishments.
FSIS should present specific guarantees concerning the quality of potable water used by each establishment. The EC undertakes to consider promptly all submissions.
24. Meat temperature requirements
Discussions indicate that the US system appears to obtain meat temperatures required by EC legislation.
The EC will consider whether the temperatures achieved operationally by the US system are acceptable.
The US will incorporate provisions in FSIS instructions to ensure that the veterinarian in charge effectively enforces EC meat temperature requirements.
33. Necessity for separate room to clean stomachs and intestines
It is agreed by both sides that EC legislation (Dir 64/433) does not require a separate room provided that the conditions enumerated in Chapter 11, 14c of that directive are fulfilled.
A clarification of the EC requirements on this point should be considered with a view to indicating that in relation to green offal from pigs, partitioning should be required, on a case by case basis, where it is necessary to prevent contamination of fresh meat or offals.
34. Handling of red offal
Withdrawn. The problem arose from a misunderstanding of EC requirements and should not arise in the future.
35. Offal handling (pig tonsil removal)
It is agreed by both sides that the removal of pig tonsils should be made in a way to prevent contamination of the head and tongue. The issue should be solved during plant review.
A clarification of the EC instructions - (VM) on this point should be considered.
36. Separation of operations
Withdrawn on the understanding that no condiments or spices will be handled or used in the same place where fresh meat is handled, cut or chopped.
40. Eviscerators boots and apron wash
The US side confirms that it applies the same requirements to imported and domestically produced products. That is to say that the US only requires washing when contamination occurs. As a result of the discussions that have taken place in the context of these negotiations any misunderstanding of US requirements should have been eliminated.
Future questions arising from the application of these requirements should be addressed during plant review.
(See Annex IV).
52. Administrative actions (submissions of monthly reports)
In the overall context of equivalency there should be periodic visits by a veterinarian at supervisory level of the exporting country to approved establishments, in principle on a monthly basis. Further details for this issue should be established within the framework of Annex IV including the matter of confidentiality.
Written reports of the above visits should be made available to the visiting inspection officials representing importing countries.
Such visits or reports should not be required during periods when establishments are not operating or are not engaged in producing products for exportation to the host country. See Annex III and IV.
53. Administrative actions (control of transit products)
The problem appears to arise from the requirements of countries of destination (insisting upon having sealed containers opened at the transit point)and not the U.S. See Annex IV.
54. Demands made of EC veterinary services for certification on quality matters
Not addressed at technical level in accordance with the agreement to exclude these issues from these talks.
55. Demands made of EC veterinary services for residues
Not addressed at technical level in accordance with the agreement to exclude these issues from these talks.
The USDA will undertake to rapidly process applications from Member States which are not now recognised as free from certain diseases by USDA. For the purpose of recognition of disease free status, USDA will undertake to accept EC legislation which is legally binding on all Member States, where it exists and is the legal basis for animal disease control measures and animal health policy in relation to imports of live animals, meat and products.
The EC Commission will undertake to provide the necessary data to expedite the listing of Member States as free from animal diseases as appropriate.
58. Recognition of regional health status
The EC has submitted a document to APHIS, entitled "The EC Single Market - a new strategy in the field of animal and plant health". This details the management structure for dealing with epizootic animal disease in the EC.
On the basis of the EC strategy paper the USDA recognises that EC policy for disease control on a regional basis may give acceptable guarantees to prevent the spread of animal disease via products of animal origin.
Both sides recognise the potential benefits of the regionalisation concept when dealing with outbreaks of exotic epizootic diseases, and that the criteria for definition of the region and the method of management of the region are critical.
The US will reconsider its import policy in the light of the regionalisation concept, and if appropriate, will undertake to amend its regulations and legislation concerning FMD, Rinderpest and other relevant diseases.
APHIS has established a working group to study the application of the regionalisation concept to animal disease control measures.
ANNEX II
INTERIM MEASURES
ANNEX III
ENHANCEMENT OF F.S.I.S. ROLE
IN RELATION TO INSPECTION AND
ASSURANCES CONCERNING PLANT LISTING
8. Inspection Operations
An important part of the regulatory function performed by Inspection Operations is the implementation of the export policy developed by International Programs. The inspection activities of FSIS are carried out by a network of five regional offices, 26 area offices, and 188 inspection circuits. East regional office is managed by a regional director who is a veterinarian in the 23 areas that contain slaughter establishments the area offices are run by area supervisors who are veterinarians, and the circuit supervisors who manage the slaughter inspection circuits in these areas are also veterinarians. This pyramidal structure has at its base the inspector-in-charge (IIC) in the slaughter establishments. Thus, the chain of command in Inspection Operations runs from the Deputy Administrator to the Regional Directors through the area supervisors to the circuit supervisors and finally to the IICs.
Built into the Inspection Operations organizational structure is a system of checks that begins with the oversight function of the regional and area offices. However, the key link in the chain of command between the regional/area level and the establishments themselves is the circuit supervisor. This means that he also is the principal conduit of information between the establishments and the Export Coordination Division of International Programs. The circuit supervisor is responsible for visiting all of the slaughter establishments in his circuit regularly and is required to carry out an in-depth review of each facility, including a check for compliance with foreign countries' import requirements. This review yields a written report which, when necessary, forms the basis for a plant improvement program to address specific deficiencies noted by the circuit supervisor. In many cases, the area supervisor and slaughter and processing experts from the regional office join the circuit supervisor when he makes the quarterly reviews.
II. Control and Responsibility at Plant Level
A. Slaughter Establishments
The inspector-in-charge in each slaughter establishment is responsible for inspection and control of slaughter operations. In all but the smallest facilities, the IIC is a veterinarian, and he is assisted by a staff composed of other veterinarians and meat inspectors. The IIC's specific responsibilities include certifying that foreign countries' requirements, as they are recorded in the instructions from Washington, are being met. Although the IIC normally delegates certain parts of his overall responsibility (post-mortem inspection, for example) to his staff, his signature must appear on the export certificate. By signing the export certificate for a consignment of products destined for the EC, for example, the IIC certifies that the products in that consignment qualify for export to the Community.
The information regarding EC requirements in the Export Coordination Division Database will be used by the veterinary chain of command responsible for the review of facilities wishing to be approved for export to the Community.
Based on these plant visits FSIS/ECD will nominate plants for EC review.
Administratively the EEC will be asked by FSIS/ECD only to visit plants they fully believe meet the EC requirements after these in depth reviews of the facility concerned.
Following the request of the FSIS, the EEC will undertake to make inspection visits without undue delay.
FSIS/ECD personnel will accompany EC review teams.
Following visits by EEC reviewers, FSIS/ECD will address correction of deficiencies in order to obviate visits by EEC Officials, and will certify the correction of deficiencies.
The inspector in charge of each establishment shall use the data base information regarding EC requirements in order to fulfill specific responsibilities including certifying that EC requirements are met.
The same data base information regarding EC requirements in the Export Coordination Division Database will be made available to the EEC. The contents and any changes envisaged by either side will be agreed by ongoing cooperation procedures.
The written reports of periodic routine oversight visits by the veterinary chain of command will be available on request to visiting foreign reviewers.
FSIS will immediately notify EC authorities when it determines that operations in a plant are incompatible with EC requirements, and after changes such as cessation of operation or significant structural or operational alterations.
Slaughter premises will have constant veterinary presence, cutting premises will be visited at least once a day by an official veterinarian and stores will be visited periodically by an official veterinarian when they are not under the supervision of the veterinary inspector in change of combined plants. The responsible veterinarian shall have control of US stamps and brands which are kept in locked premises. EC labels and marks will also be under the control of the veterinarian (and kept in locked facilities). The responsible veterinarian shall sign all EEC health certificates. (Issue items 13 & 14).
Ante-mortem inspection will be carried out by a veterinarian. (Issue item 5).
5. Based on the experience gained from the operation of the above system, the US requests that plants certified by the FSIS as being in compliance with EC requirements be approved by the EC prior to visit by EC inspectors.
6. The EEC will consider in the context of a mutually agreed approach, the possibilities of approving plants certified by the competent authorities of Third Countries prior to visits by EC reviewers.
ANNEX IV
PROPOSAL FOR US-EC
COOPERATION PROCEDURE
ANNEX V
United States Food Safety Washington, D.C.
Department of and Inspection 20250
Agriculture Service
April 27, 1992
Mr. Thad Lively
Agricultural Officer
U.S. Mission to the European Communities
PSC 82 Box 002
APO AE 09742
Dear Thad:
Following is the structure and control of the export operations of the Food Safety and Inspection Service.
1. Organizational Structure
The Food Safety and Inspection Service (FSIS) is composed of five major program areas, each of which is headed by a Deputy Administrator who answers directly to the Administrator (see Figure l-l). The two program areas that play the largest role in ensuring that fresh meat for export to foreign countries is safe, wholesome, and accurately labeled are International Programs and Inspection Operations. As is the case with all five program areas, International Programs and Inspection Operations are organizationally linked through the Office of the Administrator. However, in practice these two program areas coordinate their activities at the appropriate working levels.
A. International Programs
Within International Programs, responsibility for developing and coordinating export policy rests with the Export Coordination Division. The Director of the Export Coordination Division is a veterinarian and there are five veterinarians on the staff of the division. Based on an ongoing review of the import requirements of roughly 60 foreign countries, including every EC member state, the Export Coordination Division has developed a database that contains instructions on how to satisfy the requirements for every product exported to each country. FSIS policy on exports to any given country is translated into regulatory practice through the instructions contained in this database. (See attached instructions for exports to the United Kingdom). The database can be accessed directly by exporting establishments, and paper copies of the instructions, including updates and other amendments, are provided by the Export Coordination Division to the Regional Office of Inspection Operations for dissemination to exporting establishments.
In addition to updating and disseminating these instructions, the Export Coordination Division also is responsible for maintaining lists of establishments that are approved for export to specific foreign countries. Visits by foreign reviewers to these establishments are managed by the Export Coordination Division from all but the smallest facilities, the IIC is a veterinarian, and he is assisted by a staff composed of other veterinarians and meat inspectors. The IIC's specific responsibilities include certifying that foreign countries' requirements, as they are recorded in the instructions from Washington; are being met. Although the IIC normally delegates certain parts of his overall responsibility (post-mortem inspection, for example) to his staff, his signature must appear on the export certificate. By signing the export certificate for a consignment of products destined for the EC, for example, the IIC certifies that the products in that consignment qualify for export to the Community.
The IIC does not control (physically) U.S. or EC labeling materials. (The IIC does control the USDA brand that is applied on the kill floor). Although the IIC is responsible for ensuring that all product leaving the slaughterhouse is properly identified, plant management actually purchases, stores, and applied (under FSIS supervisor) all U.S. and EC labels. While the IIC is not directly responsible for the labeling material, he does have complete control over export certificates. All export certificates are issued directly to the IIC from the regional offices. The IIC is responsible for maintaining an inventory of certificates in his possession and keeping them in a secure place. As an additional control, all cartons in a given shipment are stamped with the number of the export certificate that is prepared for that shipment and the stamp used for making the cartons is controlled by the IIC.
B. Cutting Plants and Cold Stores
Consistent with FSIS regulations, a trained veterinarian normally is not present in most cutting plants and cold stores in the United States. However, both types of facility are under the supervision of the circuit supervisor, who is in most cases a veterinarian. Normally it is possible to satisfy the EC's requirements for veterinary supervision by ensuring the presence of a veterinarian when cutting is being done for the EC market or product in cold stores is being prepared for export to the Community. In the majority of cases, FSIS is able to accommodate facilities interested in exporting to the EC because the cutting premises are part of an integrated plant headed by an IIC or cold stores are located near an EC-approved slaughterhouse.
William H. Dubbert
Deputy Administrator
International Programs
FINAL DRAFT
5. Antemortem Inspection by an Official Veterinarian
Issue: Should antemortem inspections be performed by official veterinarians?
U.S. 9 CFR 311.1 - Disposal of diseased or otherwise adulterated carcasses and parts; general - The veterinary medical officer shall exercise his judgement regarding the disposition of all carcasses or parts of carcasses under this part in a manner which will ensure that only wholesome, unadulterated product is passed for human food (legal requirement that dispositions of all carcasses be based on judgement of veterinary).
U.S. - Meat and Poultry Manual permits up to 90% of sorting prior to observation of the animals by FSIS inspectors to be carried out by non-veterinarians and non-inspectors.
U.S. - 9 CFR 309.1(a): "All livestock offered for slaughter in an official establishment shall be examined and inspected...before slaughter." (No legal requirement that antemortem inspection be performed by a veterinarian)
Basis for Requirements:
A. U.S.
Insofar as the European Community and the U.S. cattle brought to slaughter are similar in age and health status, the two systems are parallel to one another. Under both EC and U.S. systems, each animal that has served more than one purpose during its lifetime before going to slaughter is thoroughly examined by a veterinarian upon antemortem inspection. The difference between the EU and U.S. systems lie in the handling of animals that are unique to the U.S. cattle industry and for which there is no counterpart in the EC system.
I. U.S. Cattle Industry
The U.S. cattle industry is composed of utility and feedlot animals.
Utility cattle are culled at the end of their productive life. Cull animals represent 15% of the animals presented for slaughter and deemed fit for human consumption. These animals have served more than one purpose during their lifetimes. For example, they may have been used in dairy production or as breeders in the cow/calf herds. Characteristically, they are older and subject to a variety of health problems. When they are presented for slaughter, they require close scrutiny by a veterinarian.
are presented for antemortem inspection and slaughter. Each establishment using this option must have prior approval of the FSIS Area Supervisor; who is a veterinary medical officer. The initial screening is done by feedlot operators on a daily basis. These feedlot employees are responsible for feeding and caring for the animals and see them every day. If an animal is seen to be feeling ill or is doing poorly for some reason, that animal is removed from the competition of the large herd and raised in a smaller pen until it regains its health and strength. All fed animals in this system are under close scrutiny by the contract veterinarian who is employed by the feedlot. Following the initial screening, FSIS personnel, either a veterinarian or an FSIS non-veterinarian inspector, observe 100 percent of the animals at rest. Then a representative sample of the herd (5 to 10 percent) is selected from several lots and inspected again, this time only while in motion, and from both sides. Any abnormal animals are given another full, traditional examination by a veterinarian - at rest and in motion, and from both sides. The VMO then makes a final disposition.
IV. Experience of the U.S. System
During the nine decades that these three systems have been used and refined in the U.S., they have proven to be highly effective (in sorting and removing animals that are deemed unfit for human consumption.
Trichinae destruction requirements
Issue: What time/temperature combinations are necessary to completely destroy trichinae
Legislation:
EC - Directive 77/96 or 12/21/76, Annex IV:
"6. The temperature in the refrigeration room must be at least - 25 degrees C."
"7. Meat with a diameter or thickness of up to 25 cm must be frozen for at least 240 consecutive hours, and meat with a diameter or thickness of between 25 and 50 cm must be frozen for at least 480 consecutive hours."
U.S. - 9CFR 308.3 (c)(2) states acceptable time/temperature relationships. (Tables 1 and 2)
Analysis: The problem arises from a difference in the legal requirements.
Basis for requirement:
A. U.S.
The time and temperature relationships in Table 1 have been used by the USDA for over 40 years. Those in Table 2 were added in 1973? The time and temperatures in Table 1 are based on work by Ransom (1920). Over the years it has been noted that Ransom worked mainly with air temperature in ordinary cold storage facilities where the rate of change in the temperature of the meat containing the parasite was relative slow (Augustine, 1933; Blair and Lang 1934).
Augustine (1952) and Gould (1949) concluded that trichinae could be destroyed by lowering the temperature of the product to -35 degrees C and -37 degrees C respectively. (However, to attain these temperatures with conventional, mechanical freezing techniques available at that time was highly impractical. With the advent of cryogenic materials, such as liquid nitrogen and liquid nitrogen and liquid carbon dioxide, the attainment of the -35 degrees C in pork tissues under commercial condition is feasible and practical.
With this in mind Zimmermann (1972) studied the effectiveness of these freezing materials for the destruction of trichinae and the minimum temperatures required to render the product safe for consumption without further treatment. He showed that a product temperature of -29 degrees C rendered the product free of trichinae.
A Report on the April
8-18, 1991
Visit of a United
States Department of
Agriculture (USDA)
Team to France
Regarding the Outbreak
of Trichinosis
in Humans
Team Members:
Robert Fetzner, D.V.M.; Caldwell W. Nash; Charlotte I. Miller, Ph.D.
Report Editor:
Linda Russell, M.A.
DRAFT
June 20, 1991
United States
Department of Agriculture
Food Safety and
Inspection Service (FSIS)
International Programs
Washington, D.C.
Taken From the Proceedings of the 95th Annual Meeting Of The United States Animal Health Association, San Diego, California, 1991
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