U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-1 - APPROVAL OF FACILITIES TO EXPORT TREATED HIDES AND SKINS OF UNGULATES TO THE EUROPEAN UNION I. PURPOSE The purpose of this article is to: Explain the European Union s (EU s) requirements for U.S. exports to the EU of treated hides and skins of ungulates; and Standardize Animal and Plant Health Inspection Service (APHIS) field inspections of exporting facilities of these products. This article does not apply to: tanned hides and skins, or fresh or chilled hides and skins (unsalted). II. Background REGULATION (EC) No. 1774/2002, published October 3, 2002, establishes the requirements for importing animal by-products not intended for human consumption into the EU. The regulation requires APHIS to approve facilities processing hides and skins for export to the EU. To grant this approval, APHIS must consider items such as processing methods, self-inspection programs, materials processed, and conditions of hygiene and storage. Completely tanned hides are exempt from 1774/2002. Prior to APHIS inspection of these facilities, the facilities are required to submit to APHIS for review certain forms attesting certain information about the hides and that the plant meets some minimum requirements. Following the area office s pre-inspection review of these forms, VS will schedule inspections of the facility. III. Definitions Approved facility: In this memo, this term will apply to facilities approved by APHIS to process hides and skins for export to the EU.
U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-2 - IV. EXPORT CERTIFICATION OF TREATED HIDES AND SKINS TO THE EU Prior to endorsing export certificates for treated hides or skins, area offices should ensure that facilities have been granted approval by NCIE and are included in the list of approved facilities, available in the Information Dissemination Electronic Access (IDEA) System. From the IDEA home page, located at http://inside.aphis.usda.gov/property/apps/idea.html, the area office should select Approved Animal Product Export Facilities). V. PLANT SELF INSPECTION (HACCP TYPE) The EU requires facilities that process hides and skins for export to the EU to have in place a self-inspection program similar to the Hazard Analysis and Critical Control Points (HACCP). Simply put, the HACCP system requires the facility to examine each type of hazard to which the product might be exposed. Examples of categories of hazards include: physical (e.g., metal contamination), biological (e.g., bacteria and viruses), and chemical (e.g., residues). The facility identifies whether each hazard could be present at the facility, then determines at what point (receiving, cooking, packaging, etc.) the hazard could be introduced or eliminated (or decreased to an acceptable level). This point is defined as the Critical Control Point (CCP). An example of a CCP could be the point during processing when the material reaches the maximum temperature. The facility then determines at what point, and under what conditions, the hazard can be eliminated. The condition required to eliminate the hazard is the critical limit. An example of a critical limit would be a requirement to heat items to a certain temperature to inactivate a bacteria. If the temperature required to inactivate the bacteria is 70 degrees, then the critical limit would be a minimum internal temperature of 70 degrees. The EU does not specifically require a HACCP system. Regulation EC 1774/2002 does, however, site minimal requirements that must be present in a self inspection plan. The facilities must have a written plan that includes the items listed below. This program must have all of the following elements in writing: A procedure for notifying APHIS if product is produced without meeting one of the critical limits. Certain specific CCPs and critical limits as listed below. The requirements are determined by the type of processing engaged in by the plant. Procedures to follow if a critical limit is not met. If product is produced without meeting a critical limit, the plan must state that the area office will be notified that the material is: a) destroyed, b) reprocessed, or c) sold domestically. The facility must maintain records showing results of monitoring each critical limit for at least 2 years.
U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-3 - Required CCPs and Critical Limits for Facilities Processing Hides and Skins of Ungulates for Export to the EU Processing Critical Control Point Critical Limit Method Drying Final product brittleness Hide must appear brittle enough to crack when bent. Dry or wet-salted for 14 days Minimum time in contact with salt. 14 days. (In the case of materials exported by ship, this time may include the Salted with sea-salt plus 2% sodium carbonate Dried for 42 days at a minimum of 20 degrees Celsius Minimum time in contact with salt. Minimum drying time, AND Minimum drying temperature time of voyage.) 7 days. 42 days, AND 20 degrees Celsius (Note: The EU does have in place a mechanism whereby producers can request special approval of other treatment processes.) VI. HYGIENE AND STORAGE CONDITIONS The regulation requires APHIS to approve both conditions of hygiene and storage at the facility. VII. PRE-INSPECTION PROCEDURES Prior to VS inspection of the plant, the plant management must forward to the area office: 1. Notarized Raw Material Form for Processors of Hides or Skins; and 2. Notarized Processing Method Form for Processors of Hides and Skins. Prior to inspection of the plant, the area office should confirm that the two required forms have been provided and meet all requirements. All forms should be notarized. The notarized forms should also list the position that the signatory holds in the company. The title should indicate that the individual could be expected to have knowledge of the information included in the notarized form. For example, the Raw Material Form should not be endorsed by the labeling officer. These documents should be updated (signed and provided to the area office) every year.
U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-4 - VIII. NOTARIZED RAW MATERIAL FORM This notarized form must declare that the hides and skins to be exported to the EU are only obtained from animals that: Were not affected by any signs of diseases transmissible to animals or humans, through hides or skins (i.e., anthrax); and Were not killed to eradicate any epizootic disease. The form must be the precise Notarized Raw Material Form for Processors of Hides and Skins located in this document. If attachments to the form are utilized, they must clearly be part of the same notarized document, and numbered as page 2 of 2 for example. IX. NOTARIZED PROCESSING METHOD FORM FOR PROCESSORS OF HIDES AND SKINS All facilities must provide the precise Notarized Processing Form for Processors of Hides and Skins located in this document, with one of the acceptable processing methods checked. This form will also require the facility to certify that it has in place a self-inspection program with the required critical limits. X. INSPECTION PROCEDURES Prior to arriving at the plant for the inspection, the inspector should review the forms already sent to the area office and the inspection checklist. The inspection should begin in the plant management office. The required forms and the plant self-inspection program should be reviewed with plant management at this time. The inspector may then wish to go over the checklist with the plant tour guide to establish that all questions should be addressed during the tour. The guide should then take the inspector through the facility, addressing each item on the checklist. At the end of the tour, the inspector should ask the guide to return to any areas necessary, or to show the evidence for any unanswered questions. During the inspection, the inspector should keep in mind the information he or she has reviewed in the supplied notarized forms and the self-inspection plan, and diligently observe for any indications of inaccuracies.
U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-5 - XI. BILLING FOR INSPECTIONS Inspections to approve facilities that process hides or skins for export to the EU are to be billed by the hour (Title 9, Code of Federal Regulations, Parts 156 and 130). XII. FILING OF INSPECTION REPORTS A copy of the completed inspection form and all required notarized forms should be sent to NCIE, Attention: Products Export Team, facsimile number 301-734-8226. The checklist will indicate which documents are to be forwarded to NCIE. All blanks should be completed legibly. If notes taken during the inspection are not legible, the inspection form should either be typed or completed again, in clear block letters. Illegible forms will be returned to the area office for typing. A copy of the inspection package should be maintained at the area office. The facility is not approved to export to the EU until NCIE has processed the checklist package and provided final approval. Prior to endorsing any export certificates, the area office should refer to the list of approved facilities available on the Information Dissemination Electronic Access (IDEA) System. From the IDEA home page, located at http://inside.aphis.usda.gov/property/apps/idea.html, the area office should select Approved Animal Product Export Facilities. NOTE: The information contained in the above referenced area of the APHIS Intranet is proprietary. Area offices may confirm to third parties whether facilities are approved. XIII. APPROVAL NUMBERS Facility approval numbers are issued by NCIE. VS should not endorse any export certificate for hides or skins being exported to the EU unless the facility approval number listed on the certificate is exactly a number listed in the Facilities approved by APHIS to export to the EU under EEC regulation 1774/2002. XIV. FACILITY NAME OR ADDRESS CHANGES Facilities must notify NCIE directly of changes to names or mailing addresses. This notification should be sent NCIE, Attention: Products Export Team, facsimile number 301-734-8226. Facilities should also copy the AVIC on this request. Mailing address refers to a change in the street address for the same physical building. If a facility s physical address changes, the new facility will need to be inspected.
U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-6 - APPENDIX ONE NOTARIZED RAW MATERIAL FORM FOR PROCESSORS OF HIDES OR SKINS This serves to inform officials of the United States Department of Agriculture s Animal and Plant Health Inspection Service that (Plant s name), located at (Plant s street address, including City, State, and Zip): Only processes for export to the EU, hides or skins that originate from animals that: Were not affected by any signs of diseases transmissible to animals or humans, through hides or skins (i.e., anthrax); and Were not killed to eradicate any epizootic disease. I certify that the statements listed above are true to the best of my knowledge and belief. Signed by: Date: Position : Company name: Notary signature:
U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-7 - Appendix Two Notarized Processing Method Form This serves to inform officials of the United States Department of Agriculture s Animal and Plant Health Inspection Service that (Plant s name), located at (Plant s street address, including City, State, and Zip), processes hides and skins using the below noted parameters (check appropriate selection), and has in place a self-inspection program with the critical limits referenced: Check appropriate method here: Processing Method Drying Dry or wet-salted for 14 days Salted with sea-salt plus 2% sodium carbonate Dried for 42 days at a minimum of 20 degrees Celsius Critical Control Point Final product brittleness Minimum time in contact with salt. Minimum time in contact with salt. Minimum drying time, AND Minimum drying temperature Critical Limit Hide must crack when bent. 14 days. (In the case of materials exported by ship, this time may include the time of voyage.) 7 days. 42 days, AND 20 degrees Celsius I certify that the statements listed above are true to the best of my knowledge and belief. Signed by: Date: Position: Company Name: Notary signature:
U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-8 - Appendix Three Exporters of Treated Hides or Skins Inspection Checklist 1. Animal and Plant Health Inspection Service (APHIS) Approval Number (This blank should be left blank for newly inspected facilities): 2. Plant/company name:. 3. Address of location being inspected: 4. Address of headquarters if different from: 5. Contact person at plant: Name, Telephone, Facsimile. 6. Yes No Has the plant provided you with a current NOTARIZED RAW MATERIAL FORM FOR PROCESSORS OF HIDES OR SKINS? Please attach to this checklist and forward to NCIE. 7. Yes No Has the plant provided you with a current NOTARIZED PROCESSING METHOD FORM FOR PROCESSORS OF HIDES OR SKINS? 8.. Yes No Did the plant show you a written Self Inspection program meeting the requirements outlined in section V of this document? 9. Yes No Has the facility established Critical Control Points (CCPs) for each of the critical limits noted in section V of this document (for the appropriate processing method)? 10. Yes No Is the plant maintaining CCP records for 2 years (or since the beginning of the CCP implementation if less than 2 years)? 11. Yes No Did you observe any obviously unhygienic conditions (such as loose animals on the production floor) during your inspection? (Attach explanation if answering yes. )
U.S. FACILITIES EXPORTING TREATED HIDES AND SKINS, April 2004-9 - 12. Yes No Does the plant have in place a written plan of action to implement if one of the critical limits is not reached during the processing of product, and does this plan specify that APHIS will be contacted if product is produced without meeting the critical limit? 13. Yes No Does the plant appear to have adequate storage space and equipment to meet its needs? 14. Yes No Does the facility have in place a protocol to ensure that treated hides and skins do not come into direct contact with untreated hides and skins, or other animal products or live animals? 15. Please list here the species of origin of all hides or skins exported to the EU from this facility: 16. Comments: 17. Recommendation for approval: Approve Disapprove Printed name of inspector Signature of Inspector Inspection Date Signature of Veterinarian in Charge concurring With recommendation in number 17. Date Please forward a copy of the completed form and all required notarized forms to the National Center for Import and Export, Animal and Plant Health Inspection Service, 4700 River Rd., Unit 40, Riverdale, MD 20737-1231 (telephone: 301-734- 3277; fax: 301-734-8226). Note: To maintain approval, facilities must be inspected at least once every 12 months.