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Appendix E: Regulations Governing the Packaging, Labeling, and Transport of Infectious Agents
Pages 187-204

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From page 187...
... VS Form 16-18, Authorized Entry Label..... Excerpt from, and Instructions Based on, Code of Federal Regulations, Title 42, Part71 Foreign Quarantine: Importation of Etiological Agents, Hosts, and Vectors Importation or Transfer Authorization Label (CDC 0.1007)
From page 188...
... A person who resides in the United States or operates a business establishment within the United States, to whom a permit to import or transport organisms or vectors has been issued under the regulations. APPENDIX E EXCERPT FROM CODE OF FEDERAL REGULATIONS, TITLE 9, PART 122 ORGANISMS AND VECTORS Animal and Plant Health Inspection Service, USDA (h)
From page 189...
... x9 Before most cell lines can be imported, safety tests must be conducted at the APHIS Foreign Animal Disease Diagnostic Laboratory at Plum Island, N.Y., a high-security facility located off the northeastern tip of Long Island. Generally, the tests employ recently developed in vitro methods, which are considerably faster and less expensive than previous safety tests conducted in living animals.
From page 190...
... Cost of in vitro safety tests was about $500 per test, depending on the animal diseases present in the county of origin and the intended use of the material being imported. Safety testing may not be required for some cell cultures imported for human diagnostic or research purposes.
From page 191...
... Applicants desiring to have material safety tested must enter into a Cooperative Trust Fund Agreement with APHIS, VS, and deposit sufficient funds to cover the estimated cost for safety testing in advance. The Import-Export Animals and Products Staff will initiate the Cooperative Trust Fund Agreement.
From page 192...
... F If an importer wishes to import cell cultures and/or hybridoma cells on a regular basis, the applicant may enter into a continuous Cooperative Trust Fund Agreement with VS and establish an escrow account to ensure no unnecessary delay will occur because of lack of funds (Attachment 4~.
From page 193...
... U S DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE VETERINARY SERVICES FEDERAL BUILDING, HYATTS~LLE, MARYLAND 20782 APPLICATION FOR PERMIT TO: O IMPORT CONTROLLED MATERIAL C] IMPORT OR TRANSPORT ORGANISMS OR VECTORS INSTRUCTIONS: Submit 2 copies to address above.
From page 194...
... which have been used to cut tiva te the cell s ? Country of origin and source of any animal viruses utilized in the laboratory where the cell line originates?
From page 195...
... GOVERNMENT PRINTING OFFICE: 1987-190~7B4 UNITED STATES DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE VETERINARY SERVICES -VETERINARY PERMIT INTERNATIONAL AND DOMESTIC C0NTR0L ORGANISMS AND VECTORS |PERMIT NO. DATE ISSUED DATE EXPIRES (For purposes O.!
From page 196...
... , the following steps will be taken to obtain the Cooperative Trust Fund Agreement: 1. A copy of the application with other pertinent information will be submitted to FADDL, Plum Island, New York, to obtain cost estimates for the required safety tests.
From page 198...
... In applying this section, Customs officers may request advice of the nearest quarantine office or Program headquarters if a question should arise as to the necessity for a permit in any individual instance. In giving advice, quarantine officers should be guided by the principle that the intent of this section is to keep out of the United States communicable diseases and also vectors or hosts not commonly found in this country.
From page 199...
... 199 4. To obtain an importation permit, one should complete the attached permit application form and send to: Office of Biosafety, Centers for Disease Control, Atlanta, Georgia 30333.
From page 200...
... Expiration Date TO: Bib DO NOT OPEN IN TRANSIT BIOMEDICAL MATERIALS ETIOLOGICAL AGENTS OR VECTORS NOTICE TO CARRIER: If inspection on arrival in U.S. reveals evidence of damage or leakage, immediately notify: Director,Centers for Disease Control, Atlanta, Georgia 30333-Telephone 404-633 - 5313.
From page 201...
... . Additional Handling Information I hereby declare that the contents of this consignment are fully and accurately described above by proper shipping name and are classified, packed, marked and labelled, and are in all respects in the proper condition for transport by air according to the applicable International and National Government Regulations.
From page 202...
... 'lbe requirements of the part are D addition to and not in lieu of any other pack40 or other requirements for the transportation of ethloglc agents in mteratate traffic prescribed by the Department of Transportation "d other agencies of the Federal GovernmenL APPENDIX E EXCERPI FROM CODE OF FEDERAL REGULATIONS, TITLE 42, PART 72 INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS ~ =2 Or_ d - _b ~ ~ ma_ ~ _ _ __ ~ -w_ ~P~ Qua-~ No person may knowingly Sport or cause to be transported in interstate traffic' directly or indirectly, any material including, but Apt limited kit diagnostic specimens and biological products which such person reasonably believes may contain an etiolog{c agent unless such material is packaged to withstand leakage of contend, Sock pressure changes. and other condition incident to ordinary handling in transportation.
From page 203...
... . If dry ice ~ used between the secondary container and the outer shipping container, the shock absorbent material shall be placed so that the secondary container does not become loose inside the outer shipping container as the dry ice sublimates.
From page 204...
... ~ Public Health Service Interstate Quarantine Regulations (42 CFR, Section 72.25(c)


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