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Appendix E Regulations Governing the Packaging, Labeling, and Transport of Infectious Agents CONTENTS Excerpt from Code of Federal Regulations, Title 9, Part 122~rganisms and Vectors . eeeeeeeeeee-.eeee Statement from USDA's Animal and Plant Health Inspection Sernce on Requirements for Importing Cell Cultures 189 Veterinary Services March 1986 Memorandum on Importation of Cell Cultures Including Hybridomas 191 Attachment 1 VS Form 1~3, Application for Permit to Import Controlled Material or to Import or Transport Organisms or Vectors 193 Attachment 2 Importation Information Questionnaire for Cell Lines 194 Attachment 3- VS Form 16-3A, Veterinary Permit, International and Domestic Control, Organisms and Vectors Attachment 4 Procedure to Complete Trust Fund Agreement for Safety Testing of Cell Cultures, Including Hybndomas ........... 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) . . .. . . . . .. . . . . .. . . . . . . Shipper's Declaration for Dangerous Goods lQnmnl" Rem . . 196 197 .. 198 . . . 200 \~-~^VAB&BJe- ~e 201 Excerpt from Code of Federal Regulations, Title 42, Part 72-Interstate Shipment of Etiologic Agents . . . .. . 202 ... 195 Notice to Camer Label (CDC) 204 The importation and interstate transport of infectious agents is subject to several federal regulations. In this appendix, most of the relevant regulations and fonns are reproduced for the infonnation of those who will use this repom Federal regulations and forms are subject to revision, and the reader is urged to consult the most up-to date version of the Code of Federal Regulations, as well as relevant offices in the U.S. Department of Agriculture and the Public Health Service, to remain abreast of changes that may have occurred. 187

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88 9 CFII Ch. I (1-1-88 Edition) PART 122 ORGANISMS AND VECTORS Sec. 122.1 Definitions. 122.2 Permits required. 122.3 Application for permits. 122.4 Suspension or revocation of permits. AUTHORITY: Sec. 2, 32 Stat. 792, 37 Stat. 832-833; 21 U.S.C. 111, 151-158. EDITORIAL NOTE: For nomenclature changes, see 36 F'R 24928, Dec. 24, 1971. 122.1 Definitions. The following words, when used in the regulations in this Part 122, shall be construed, respectively, to mean: (a) Department. The U.S. Depart- ment of Agriculture. (b) Secretary. "Secretary" means the Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be del- egated, to act in his stead. (c) Veterinary Services. The Veteri- nary Services unit of the Department. (d) Deputy Administrator. The Deputy Administrator, Veterinary Services or any officer or employee of the Veterinary Services to whom au- thority has heretofore lawfully been delegated, or may hereafter lawfully be delegated, to act in his stead. (e) Organisms. All cultures or collec- tions of organisms or their derivatives, which may introduce or disseminate any contagious or infectious disease of animals (including poultry). (f) Vectors All animals (including poultry) such as mice, pigeons, guinea pigs, rats, ferrets, rabbits, chickens, dogs, and the like, which have been treated or inoculated with organisms, or which are diseased or infected with any contagious, infectious, or commu- nicable disease of animals or poultry or which have been exposed to any such disease. (g) Pennittee. 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 vec- tors has been issued under the regula- tions. APPENDIX E EXCERPT FROM CODE OF FEDERAL REGULATIONS, TITLE 9, PART 122 ORGANISMS AND VECTORS Animal and Plant Health Inspection Service, USDA (h) person. Any individual, firm, partnership, corporation, company, so- ciety, association, or other organized group of any of the foregoing, or any agent, officer, or employee of any thereof. t31 FR 81, Jan. 5, 1966] 122.2 Permits required. No organisms or vectors shall be im- ported into the United States or trans- ported from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia without a permit issued by the Secretary and in compliance with the terms thereof: Provided, That no permit shall be required under this section for importation of organisms for which an import permit has been issued pursuant to Part 102 of this subchapter or for transportation of or- ganisms produced at establishments li- censed under Part 102 of this subchap- ter. As a condition of issuance of per- mits under this section, the permitted shall agree in writing to observe the safeguards prescribed by the Deputy Administrator for public protection with respect to the particular importa- tion or transportation. (Approved by the Office of Management and Budget under control number 0579- 0013) t28 FR 7896, Aug. 2, 1963. Redesignated at 31 FR 81, Jan. 5, 1966 and amended at 48 FR 57473, Dec. 30, 1983] 122.3 Application for permits. The Secretary may issue, at his dis- cretion, a permit as specified in 1122.2 when proper safeguards are set up as provided in 122.2 to protect the public. Application for such a permit shall be made in advance of shipment, and cash Hermit shall specify the name and address of the consignee, the true name and character of each of the organisms or vectors involved, and the use to which each will be put. (Approved by the Office of Management and Budget under control number 0579- 0015) t23 FR 10065, Dec. 23, 1958. Redesignated at 31 FR 81, Jan. 5, 1966 and amended at 48 FR 57473, Dec. 30, 19831 122.4 Suspension or revocation of per- mite. (a) Any permit for the importation or transportation of organisms or vec- tors issued under this part may be for- mally suspended or revoked after op- portunity for hearing has been accord- ed the permitted, as provided in Part 123 of this subchapter, if the Secre- tary finds that the permittee has failed to observe the safeguards and instructions prescribed by the Deputy Administrator with respect to the par- ticular importation or transportation or that such importation or transpor- tation for any other reason may result in the introduction or dissemination from a foreign country into the United States, or from one State, Territory or the District of Columbia to another, of the contagion of any contagious, infec- tious or communicable disease of ani- mals (including poultry). (b) In cases of wilfulness or where the public health, interest or safety so requires, however, the Secretary may without hearing informally suspend such a permit upon the grounds set forth in paragraph (a) of this section, pending determination of formal pro- ceedings under Part 123 of this sum chapter for suspension or revocation of the permit. [23 ~" 10065, Dec. 23, 1958. Redesignated at 31 FR 81, Jan. 5, 1~1 *Code of Federal Regulations. 1988. Part 122, Organisms and Vectors, in Chapter 1, Animal and Plant Health lbspection Service.

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APPENDIX E STATEMENT FROM USDA'S ANIMAL AND PLANT HEALTH AND INSPECTION SERVICE ON REQUIREMENTS FOR IMPORTING CELL CUL~RES** IMPORTING CELL CULTURES: REQUIREMENTS TO PROTECT U.S. AGRICULTURE Some researchers don't know it- and others have found out the hard way-but they need a permit from the U.S. Department of Agriculture to bring cell cul- tures into the United States. USDA's Animal and Plant Health Inspection Service requires permits for importing cells or their culture medium because of the possibility they might carry foreign animal dis- eases that could devastate a highly susceptible U.S. livestock population. Cell cultures and similar materials arriving in this country without permits are confiscated and destroyed by agricultural inspectors at U.S. ports of entry. In- spectors have scientific backgrounds and don't like having to set back research. But at that point there is no alternative. Protection against introduction of organisms from abroad must be built into the import procedure ahead of time. A major concern is foot-and-mouth disease (FMD), which is found throughout most of the world. Two of the six FMD outbreaks that occurred in the United States early in this century were traced to contami- nated cowpox vaccine. FMD has not occurred in the United States since 1929, when stringent import laws were enacted. Although scientists have exchanged cell lines for many years, there is a large increase in this activity. One reason is the great popularity of monoclonal antibodies as research tools because of their high specificity and reproducibility. Monoclonal antibod- ies are produced by hybridomas, which are lines of hybrid cells formed by fusing mammalian cells. Fe- tal calf serum, a possible source of FMD virus, is used to produce virtually all such cultures. 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 re- cently developed in vitro methods, which are consid- erably faster and less expensive than previous safety tests conducted in living animals. However, tests for FbID still require the use of live animals. To get an impart permit, complete the questionnaire "Importation Information" and fH1 out VS Form 16- 3. Send both documents to: Organisms and Vectors Section Import-Export and Emer~encv Planning Tiff VS-APHIS-USDA 6505 Belcrest Road Hyattsville, MD 20782 (Phone: 301436-5453) A, , O Applicants will be notified if a safety test is required. If so, they will be told the estimated cost, and they must then deposit funds to cover this cost. Importers bringing in cell cultures or hybridoma cells on a regular basis can establish an escrow account, which avoids the need to forward funds for each import A minimum of four vials, each containing at least 1 million cells from a uniform lot, is required for a safety test. The normal working time for issuing a permit, com- pleting safety tests, and transferring the imported material is 60 to 90 days. To expedite the procedure, APHIS may issue a permit for the material to be shipped to the Foreign Animal Disease Diagnostic Laboratory at Plum Island, N.Y., pending receipt of the funds. However, actual testing will not begin until the funds are in hand. Cost of testing varies. In early 1986, an in viva safety test using susceptible **Repented from APHISF=~, Jam 1986. Was~gt - , Do: U.S. fit of Agents, Andy and Hant Heath ~ - Serv~ce.

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190 host animals cost from $2,000 to $3,000. However, it sometimes was possible to cut costs by pooling samples for host animal tests. Cost of in vitro safety tests was about $500 per test, depending on the ani- mal 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. Some examples are cultured human bone marrow cells, amniocentesis samples, or cells to be know APPENDIX E Official information on Federal requirements for importing cell cultures (including hybridomas) is published in Veterinary Services Memorandum 593.1, March 11, 1986, which is available Dom the Organ- isms and Vectors Section. This group can also pro- vide additional details and answer questions from prospective importers. Researchers should plan their imports as far in ad- vance as possible. That way, the actual import will proceed smoothly and expeditiously when the time comes.

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APPENDIX E Subject: Importation of Cell Cultures Including Hybridomas Area Veterinarians in Charge, VS Directors, VS Regions Vetennary Medical Officers, VS Veterinary Medical Officers, PPQ Director, National Vetennary Services Laboratories Director, National Program Planning Staffs Chief, Foreign Animal Disease Diagnostic Laboratory I PURPOSE The purpose of this memorandum is to provide updated information on importing cell cultures, including hybridomas, that may require safety testing. II CANCELLATIONS This memorandum replaces VS Notice dated June 25, 1985. III POLICY It is Veterinary Services policy that no animal- origin biological materials such as cell cultures, monoclonal antibodies, or related material may be imported into the United States without a Veteri- nary Services (VS) permit (VS Form 16-3A). IV GENERAL A. To obtain an import permit, an application (VS Form 16-3) should be submitted to: Import-Export Staff, Organisms and Vectors VS, APHIS, USDA 6505 Belcrest Road Hyattsville, MD 20782 191 VETERINARY SERVICES MARCH 1986 MEMORANDUM ON IMPORTATION OF CELL CULTURES INCLUDING HYBRIDOMAS Vetennary Services Memorandum 593.1 A sample copy of the application (Form 16-3) is enclosed (Attachment 1). Applicants must also com- plete the questionnaire entitled "Importation Infor- mation" (Attachment 2) and submit it with their ap- plication. B. The information requested in these forms is necessary for proper evaluation of the request. In- complete information will result in denials or delays in processing the application. Based upon the infor- mation submitted by the applicant, a determination will be made if the material to be imported requires safety testing to ensure it is free from livestock patho- gens. Safety testing can be conducted at the Foreign Animal Disease Diagnostic Laboratory (FADDL), Plum Island, New York. C. Applicants will be advised if a safety test is required and will be given an estimate of the cost for conducting the test. 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. In order to expedite the procedure, VS may issue a permit for the material to be shipped to FADDL pending receipt of the funds and Coopera- tive Trust Fund Agreement. However, the signed Cooperative Agreement, plus the necessary funds, must have been received by VS before testing can be scheduled at FADDL. D. The normal working time for issuing a per- mit for importing material to Plum Island, New York, completing safety tests, and transferring the imported material to the applicant is 60 to 90 days. A mini- mum of four vials, each containing at least one mil- lion cells from a uniform lot, is required for a safety test. E. Once the safety test is completed and a de- termination made Hat the imported material is free from livestock pathogens, the remainder of the im

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192 ported material will be released directly to the im- porter under conditions specified in the permit (At- tachment 3~. F. If an importer wishes to import cell cultures and/or hybridoma cells on a regular basis, the appli- cant 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~. G. Presently, in viva safety tests utilizing sus- ceptible host animals usually cost approximately $2,000 to $3,000 per test. Sometimes it is possible to reduce the cost by pooling samples in one host ani- mal test. Scientists at FADDL have developed in vitro safety tests to detect certain livestock patho- gens resulting in substantial cost savings for importers. In vitro safety tests for additional diseases are being developer Current cost for in vitro tests is approxi- mately $500 per test depending upon animal disease present in the country of origin and the intended use of material being imported. H. Safety testing may not be required for some cell cultures imported for human diagnostic purposes and research. Examples of material which would qualify without safety testing include cultured hu- man bone marrow cells, amniocentesis samples, or cells to be karyotypede Applications for such cell cultures will be individu- ally evaluated. I. The following classification of cell cultures is based on intended use and generally indicates the level of safety testing required. APPENDIX E Class I Cell cultures to be used for the pro- duction of products such as vaccines, hormones, or other biologicals to be used in livestock, poultry, or for commercial distribution. Requirement These cell cultures must be safety tested at FDDL using susceptible host animals, approved in vitro test and/or laboratory ani- mals. Class II Cell cultures to be used only for in vitro studies and not to be used in animals over than primates. Requirements: These cultures may not require safety testing. The material may be sent di- rectly to the importer when no safety testing is required. The permit (VS form 16-3A) will specify restrictions such as "FOR IN VITRO LABORATORY TESTS: DO NOT INOCU- LATE INTO LIVESTOCK, BIRDS, OR LABORATORY ANIMALS." J. Cell cultures imported under permit which do not require a safety test may not be distributed to other laboratories without prior approval from USDA, APHIS, VS. Applications for the distribution of imported material should be submitted to the USDA, APHIS, VS, Import-Export Staff, Organisms and Vec- tors. J.K. Atwell Deputy Administrator Veterinary Services 4 Enclosures

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APPENDIX E Attachment 1 VS Form 1~3 Application for Permit to Import Controlled Matenal or to Import or Transport Organisms or Vectors No controlled mstonal, organisms or vectom Nay be imported or moved Intestate unless the data requested OD oh's form ~e furnished and certified (9 CFR 534, 95, and 122) 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. Attach additional sheets, it necessary. 3. TO: (Name, ad/dre~s, and phone no. of applicant - include Zip Code) FORM APPROVED - OMB NO 0579-0015 1 MODE OF TRANSPORTATION 2 U S PORT(S} OF ENTRY 4. FROM: (Name and address of shipper - include Zip Code) 5 DESCRIPTION Of MATERIAL (Nameofmatenal, count of orders, animal source, tic. 6 QUANTITY OF MATERIAL TO BE IMPORTED AND FREqUENCY OF IMPORTATIONS 7 PROPOSED USE OF MATERIAL, EXPECTED COMPLETION DATE, AND FINAL DISPOSITION TO Be MADE 8. DESCRIPTION Of APPLICANT'S fACILITIES AND EQUIPMENT fOR HANDLING MATERIAL 9 QUALIFICATIONS OF TECHNICAL PERSONNEL WHO WILL BE WORKING WITH THIS MATERIAL 10 METHOD OF TREATMENT OF MATERIAL /~ea~Sat~~rdl 11 WORK OBJECTIVES, PROPOSED PLAN OR WORK, AND ADDITIONAL PERTINENT INFORMATION 12 PERTINENT PUBLISHED PAPER OR ABSTRACT (PIca~~©, ~faw~bkJ CHECK IF COPY IS ATTACH E D O I CERTIFY THIS MArERlAL WILL BE USED IN ACCORDANCE WITH ALL RESTRICITONS AND PRECAUTIONS AS MAY BE SPfClFlED IN THE PERMIT. 13 SIGNATURE OF APPLICANT 14 TYPED NAME OF OFFICIAL SIGNING 15 DATE SIGNED 16 TYPED TITLE OF OFFICIAL SIGNING (JAN 88) ~Previou. odit~o~` are ob~ol." ) 193

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194 Attachment 2 Importation Information Questionnaire for Cell Lines Cell line designation, or reference number: Country of origin of cell line: Cell line passage history: Country of or igin of culture media: Type of cut Cure media: APPENDIX E Source of culture media ~ ): Country of origin and nource-of any nutritive factors of animal origin in the culture media (e.g . serum or supplements ): If serum is used, indicate percentage: If serum is used, and it is of USA origin, is a USDA Export Certificate available: Yes No . If answer is yes, give company' s name and serum lot number C~uner~r Of origin and source of any animal enzymes (e. g. trypsin) 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? If cell line is ~ hybridoma, specify fusion partners: If cell line is not a hybridoma, specify its origin or derivation (e.g. EBV transformati on of human B lymphocytes): __ _ Potential use of imported mater ial: Name and address of the institution where the material originated: signature of Authorized Company Representative Date

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APPENDIX E 7. Attachment 3 VS Form 1~3A Veterinary Permit, International and Domestic Control Organisms and Vectors ~U.S. 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.! movement from shipper to Remittee) NAME AND ADDRESS OF SHIPPER T0 | (Name and Address of Permittee) MODE OF TRANSPORTATION U. S. PORT OF ARRIVAL AS REQUESTED IN YOUR APPLICATION YOU ARE AUTHORIZED TO IMPORT OR TRANSPORT - rHE FOLLOWING MATERIALS RESTRICTIONS AND PRECAUTIONS FOR TRANSPORTING AND HANDLING MATERIALS AND ALL THEIR DERIVATIVES (Item I u always applicable and Items 2 through 11 are applicable only when "X".J This permit is issued under authority contained in Parts 94 and 122, Chapter 1, Title 9, CFR. The authorized materials or their derivatives shall be used only in accordance with the restrictions and precautions specified below. (ALTERA TIONS OF RESTRICTIONS CAN BE MADE ONL Y WHEN A UTHORIZED B Y VETERINAR Y SER VICES.J 1. Adequate safety precautions shall be maintained during shipment and handling to prevent dissemination of disease. 2. 0 Work shall be limited to IN VITRO laboratory studies only. 3. 0 This permit does not authorize direct or indirect exposure of domestic animals, including poultry, cattle, sheep, swine, horses, etc. 4. 0 All animals shall be exposed and held only in isolated insect and rodent-proof facilities. 5. 0 All equipment, animals, pens, cages, bedding, waste, etc. in direct or indirect contact with these materials shall be sterilized by autoclaving or incineration. 6. 0 Packaging materials, containers, and all unused portions of the imported materials shall be sterilized by autoclaving or incineration. O Materials shall be shipped by Registered Mail, Railway or Air Express. 8. 0 Acknowledge receipt of materials by completing and mailing attached VS Form 16-19, which requires no stamp. 9. 0 This permit is valid only for work conducted or directed by you in your present facilities. (MATERIALS SHALL NOT BE REMOVED TO ANOTHER LOCATION, NOR DISTRIBUTED TO OTHERS, WITHOUT USDA AUTHORIZATION,) 10. 0 On completion of your work, all permitted materials and all derivatives therefrom shall be destroyed and the USDA must be promptly notified by completing and mailing the attached VS Form 16-20, which requires no stamp. 11. 0 To expedite clearances at the Port of Entry the shipper should attach one of the enclosed labels to each NO. LABELS ENCLOSED package of authorized material. (Additional labels may be obtainedirom this office. SICNATU RE TITLE VS FORM 163A Pret)iou~ editions obsolete. (MAR 73) 195

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196 Attachment 4 Procedure to Complete Trust Fund Agreement for Safety Testing of Cell Cultures, Including Hybrido mas When the applicant has been advised by the Import- Export Animals and Products Staff that a safety test is required (see VS Memorandum No. 593.1, dated March 11, 1986), 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 Is- land, New York, to obtain cost estimates for the required safety tests. 2. The total cost estimate will be sent to the appli- cant. 3. The Import-Export Staff will then draft the Coop- erative Trust Fund Agreement. 4. The VS Executive Office will review the draft document for policy compliance, proper format, and funding requirements. APPENDIX E 5. The Import-Export Staff will finalize and send five copies of the Cooperative Trust Fund Agree- ment to the Cooperator for signature. 6. If the agreement is acceptable, the Cooperator will sign all copies and return the agreement to the Import-Export Staff with a check for the total cost of the tests made payable to the United States Depart- ment of Agriculture, Animal and Plant Health In- spection Service, Veterinary Services. 7. The Import-Export staff will deliver the check and Cooperative Trust Fund Agreement to the VS Execu- tive Office for a document number, final signature and processing. 8. Two copies of the executed Cooperative Trust Fund Agreement will be sent to the Cooperator for their records. 9. If an importer wishes to import cell cultures and/ or hybridoma cells on a regular basis, the importer should inform the Import-Export Staff during initial discussions. The importer may enter into a continu- ous Cooperative Trust Fund Agreement with VS and establish a revolving trust fund account.

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APPENDIX E 197 VS Fonn 16-18 Authonzed Entry Label PERISHABLE ANIMAL QUARANTINE MATERIAL AUTHORIZED ENTRY BY U.S. DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE VETERINARY SERVICES FEDERAL BUILDING HYATTSVILLE, MARYLAND 20782 PLEASE EXPEDITE '}ETER'~ARY PERMIT NO I EXPIRES l t11S PACKAGE CONTAINS VS FORM 16-18 (MAR 74)

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198 EXCERPI FROM, ANDINSTRUCllONS BASED ON, CODE OF FEDERAL REGULATIONS, Illl,E 42, PART 71 FOREIGN QUARANTINE: IMPORTATION OF ETIOLOGICAL AGENTS, HOSTS, AND VECTORS UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service 42 CF-R - Part 71 Foreign Quarantine Importation of Etiological Agents, Hosts, and Vectors 71.54. Etiological Agents, Hosts, and Vectors (a) A person may not import into the United States, nor distribute after importation, any etiological agent or any arthropod or other animal host or vector of human disease, or any exotic living arthropod or other animal capable of being a host or vector of human disease unless accom- panied by a permit issued by the Director. (b) Any import coming within the provisions of this section will not be released from custody prior to receipt by the District Director of the U.S. Customs Service of a permit issued by the Di- rector. INSTRUCTIONS 1. Classes of Imports Requiring Permits. It is impracticable to list all of the several hundred spe- cies of Biological agents and vectors that may be covered by 71.54. Certain classes of imports over which the maintenance of surveillance is important and for which permits must be obtained from the Director, Centers for Disease Control, Public Health Service, Department of Health and Human Services, or his/her authorized representative, follow: a. Any living insect, or other living mh~opod, known to be or suspected of being infected APPENDIX E with any disease transmissible to man; also, if alive, any bedbugs, fleas, flies, lice, mites, mosquitoes, or ticks, even if uninfected. This includes eggs, larvae, pupae, and nymphs as well as adult forms. b. Any animal known to be or suspected of being infected win any disease transmis- sible to man. c. All live bats. d. Unsterilized specimens of human and ani- mal tissue (including blood), body dis- charges or excretions, or similar material, when known to be or suspected of being infected with disease transmissible to man. Any culture of living bacteria, virus, or simi- lar organism known to cause or suspected of causing human diseases. f. Any snails capable of transmitting schistosomiasis. No mollusks are to be admitted without a permit from either the Public Health Service or the Department of Agriculture. Any shipment of mollusks with a permit from either agency should be cleared immediately. 2. Advice to Customs. In applying this section, Customs officers may request advice of the nearest quarantine office or Program headquarters if a ques- tion 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. When an importation does not seem likely to bring in disease or a vector or host, advice should be given to the effect that a permit is not required. In case of doubt concerning admissibility, quarantine officers should promptly make inquiry of Program headquarters.

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APPENDIX E 3. Blanket Perrruts. Blanket permits, [united as to time and material, are occasionally issued. The original blanket permit is retuned in the office to which it is issued. When it is used as authority to import quarantinable material, a certified or photo- static copy of it should accompany the shipment. The copy is cancelled and collected as in the case of a single entry permit. 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. A permit is issued to the recipient, and may be conditional upon one or more of the items indicated on the attached sample Permit.

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200 APPENDIX E Importation or Transfer Authonzation L~abe,1 (CDC 0.1007) IMPORTATION OR TRANSFER AUTHORIZED BY E PHS Permit No. 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. CDC 0.1007 6/85

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APPENDIX E 201 Shippers Declaration for Dangerous Goods (Sample Form) Proper Shipping Name _ ~ ~S - LE F83 LABELMASTER. CHICAGO IL 60646 SHIPPER'S DECLARATION FOR DANGEROUS GOODS Shipper Consignee Two completed and signed copies of this Declaration must be handed to the operator | TRANSPORT DETAILS 1 | This shipment is within the Airport of Departure I limitations prescribed for: | (delete non-applicable) l PASSENGER CARGO l AND CARGO AIRCRAFT l AIRCRAFT ONLY | Airport of Destination: Air Waybill No. Page of Pages Shipper's Reference Number (Optional) WARNING Failure to comply in all respects with the applicable Dangerous Goods Regulations may be in breach of the applicable law, subject to legal penalties. This Declaration must not, in any circumstances, be completed and/or signed by a consolidator, a forwarder or an IATA cargo agent. Shipment type: (delete non-applicable) . ~ NON-RADIOACTIVE I RADIOACTIVE | . NATURE AND QUANTITY OF DANGEROUS GOODS ~1 Dangerous Goods Identification . . . | Class, , or I , Divide ~ sion . No. _ _ ,. . . . : ~: . . . UN . Subsi-, or , diary, ID . Risk ~ Quantity and I Packing . Authorization type of packing , Inst. '. , .. . 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. I Name/Title of Signatory | Place and Date Signature (see warning above) -

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202 PART 72~1NrERSTAU RIPPER ETIOLOGIC AGED ~ Or_ 72.1 Def~nidos~. 7~2 Transportation of diagnostic specimens biological products and other materials; magnum packaged requirements. ?2.S Transportation of materials containing certain ecologic agents; minimum paclc~ requ~menb. 7Z.. Notios of delivery. failure to receive. 72~5 Requlremenb; variations. Authority: Sew 215, 58 Stat. I as amend" .2 U.S.C 216; sew 381, 58 Stat. 703. (42 USC 2~) t=1 ~ As used in this part "Biological product" means a biological product prepared and manufactured in accordance with the p - `nsions of ~ Cog PI I~tW and 2t CFR PI 312 end ~0 "d wow, accordance with such ~ may be shipped ~ interstate traffic "Diagnostic specimen" moue any human or animal material including but not limited to. excrete' secrete. blood and in components' tissue, and tissue fluids being blipped for purposes of diagnosis. "Etiologic agent" means a viable microorganism or its toxin which causes, or may cause. human disease. "Interstate traffic'! means We movement of any conveyance or the transportation of persons or property, including any portion of such movement or transportation which is entirely within a State or possession, (a) Tom a point of origin in any State or possession to a point of destination in any other State or possession. or (b] between B point of origin and a point of destination in the same State or pos~ion but through any other State, possession' or contiguous foreign country. '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. con~n~g Amp TIC minimum pit ~ub~l~ Notwithstanding the provisions of ~ 72.2, no person tony knowingly transport or cause to be transported interstate tics directly or indir~dy. any material (other than biological products) letdown to contain' or reasonably believed by such person to contain, one or more of the follow etiologic agents unless such material is packaged, labeled. and shipped in accordance with the requirements specified in paragraphs (aHf) of this section: B~1 Mob Acinetobacter calcoaceticw. Actinobaci/lw aD specials Actinomycetoc~o~l mcmbere. Ae~onos homophile Arochnia propionica Argons hinshowii ad genotypes. Bocillw anthrocis. Bocteroi~ ~ Bartonello_11 up - An. Bordetello~II spew. fiorrelia recurr~nti~ R ~mcenti. Bn~cclla_~ ~ Compylobocter(Vibrio) foes" C. {V~oJ jejuni. Chlamy~apaiffaci, C t~chomo~J. Clmtridium botulinum. Cl. chouroei, Cl. haemolyticum, C1. histoJytiewn,CI. noryf, Cl. septicum. Cl. tctoni. Corynebocterium dipAthenoe, C Phi. C. hoemolyticum. C. pecudah~srculosis. C parent C resale Edwarsiello tango. Erysipshthrix insidiosa. Escherichia colt, an ent~opathogenic serotypes. Francisello {Pastcurella} TularensJ~. Hoemophilue Delhi. ~ inftw~. /~bdii8110~ ~" am ~ ~ LegionelJo_ll species and aB Le~onella- lilce o~sme. L~p~pim intendant ram Li~ria~aD spy Mimae polymorphic Melba spa. Myco~riu~ Pea Mycoplouno~ aped - . Heieseria gono~oe, N. ~ningitit~i~ Nocardia avoids. Pasteurello_31 specter Plceiomanas sh)gelloid~ Pawn Am. P - vdomonas mo1bf. Pseudomonas p~oLhi. Salmowila_8 ~" Id an Iowa Mellow ~ ad ~ ~o~ Sphoerophon. yhan" Staphylococcus cured S - ptobacillw moniliformi~ St rep :ococc ur pa c um office. S - p~ccw ~ Treponemo carom. T. paIlidu~ ~ T. powwow. Video cholera Y. ~vlytiau. Y~L~`O(P - ~O}P - id, Y. anter~aobt~. Fly Blastomyces dermati~dis. Coccidioides immitis. CryptOcOCCUJ JJ - OnnOlt~ Histoplwma ~apeahh - . Paroooccidioid" brasiliensie. Vat "d Ray ~ Adenovinu~b~D~II tom. Arbo~riruses_ll typed Coxielb bumetii. Cox~ackie A and 8 vin~e~all types. Creut~feld - Jacob agent Cytomegal~rin~ses. Dengue Crusoe all types. Ebole emu. Echo~rin~u. all typed Encephalomyoc~tis Ann Hemorrhagic fever agents IDdud~ but Dot limited to. Crime" h~ugic fever (~88o1 1~"i" Machupo hilt`] Korean hemonha~lc fever Ma Hepeff~e assisted matenale (hepatitis JO hepaffffe B hepaffffr no~-nonB) Yelp - ~_II mambo Infectious bron~ti~lilce Suede Unseal thy. Kluu 4 - t Lay Lymphocytic chonomeninl Marburg ~rirua

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APPENDIX E Mid. ME Van Pot v~ types Pot ~ Po~ndru~ m~hra Rables ~8 s- Reovinue_ - typ - . R~h~ ~ you. BE qua Aicicttaio_D Ad. Rot quin~na. Rotavin_~ typed Rubella him. Simian ~rln~ 40. new encephalitis virus complex. Inching Texan s~s~nmer b~ti~ K,asenur forest disea - , Omsk hemorrhagic fever, and Central }European encepislitis ~es. Vacc:inia ding. Vancella dints. Variola major and Vanola minor ~riru~. Vesicular stomata v~ typo White pox I. Yellow fever I' (a) Volume not exceeding SO my Material shall be planed in a securely closed, watertight container (primary container (test tube, final. etc.)) which shall be enclosed ~ a second. durable watertight container (secondary container). Several primary contamere may be enclosed in a single secondary container, if the total volume of all the primary containers so enclosed does not exceed 50 all. The space at the top, bottom, and sides between the primary and secondary containers shall contain sufficient nonparticulate absorbent material (e.~., paper towel) to absorb the entire contents of the primary containeris) in case of breakage or leakage. Each set of primary and secondary containers shall then be enclosed in an outer shipping container constructed of corrugated fiberboard, cardboard, wood, or other material of equivalent strength. (b) Volume greater than 50 ml. Pacl~s~ng of material in volumes of 50 ml. or more shall comply with reguirements specified in paragraph (a) of this section. In addition, a shock absorbent material in volume at least equal to that of the absorbent material between the primacy and secondary containers, shall be placed at the top, bottom, and sides between the secondary container and the outer shipping container. Single primary containers shall not contain more than 1,000 ml of material. However, twe or more primary containers whose combined vol~es do not exceed 1,000 ml may be placed in a single, secondary container. The maximum amount of Clonic list may be revised from time to time by Notice publiel~ed in the Federal Renter to identify additional agents which must be paclta~ed in accordance with lax retirement contained in this pan. 203 etiolo~pc agent which may be enclosed within a single outer shipping container shall not exceed 4,000 ml. (c) Dry ice. If dry ice is used as ~ refrigerant, it must be placed outside the secondary container(~). 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. (d)(1) Me outer shipping container of all matenale containing etiolo8ic agents transported in interstate traffic must bear a label as illustrated and described below: rant ~ ___ __ ID 70_ 470 JU - 1 197.1 _tSClil~tD ., D`" Slav 4 7 Cry At BIOMEDICAL MATERIAL (2) The color of material on which the label is printed must be white, the symbol red, and the printing in red or white as illustrated. (3) The label must be a rectangle measuring 51 millimeters (mm) (2 Inches) high by 102.5 mm (4 inched long. (4) The red symbol measuring 38 mm (1~ inches) in diameter must be centered in a white square measuring 51 mm (2 inches) on each side. (5) Type size of the letters of label shall be as follows: Etiologic agents 10 pt. rear. Biomedical material-14 pt. In case of damage or leakage 10 pt. rev. Notify Director CDC. Atlanta. Georgians pt" rev. 4530 pt. rev. (e) Dan?agedpockages. The carrier shall promptly, upon discovery of evidence of leakage or any other damage to packages bearing an Etiologic Agente/Biomedical Material label, isolate the package and notify the Director, Center Or Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333, by telephone: (404) 633 5313. The carrier shall also notify the sender. (f] Registered mad or equivalent system. Transportation of the following etiologic agents shall be by registered mail or an equivalent system which requires or pro~rldes for sending notification of receipt to the sender immediately upon delivery: Coccidioides immitii. }Bob ~ Fronasello Tibia) t~laremb. Hemorrha~pc fever Mend tadudL-. but not twitted to, Crl~neen Magic fearer Cop). hi Machupo Row and Korean haDon~c fever Inca Herp-ulna dam (B Low). Histoplos~ copealohJm. Lam vim. Meyers ~- P - udomo``a~ mallet. P - udomon" peaudomallci. TicJ`.bome encepbelitu True complex indudi~ but Dot limited to. Ruwlan spr--tumbler encephalitis. Kya~nur forest disease, 0~ Hemorrhagic fever. and Central European encephel~tir Andes. Variola minor. arid Vanola major. Variola major. Vstiola minor. and Whitepex Ales. Yersinio {PosteurellaJ Testis.' I=4 'I - _~ ._. When notice of delivery of materials Mown to contain or reasonably believed to contain Etiologic agents listed in ~ 72.3(f] is not received by the sender within 5 days following anticipated delivery of the package, the sender shall notify the Director, Center for Disease ControL 1600 Clifton Road, NE., Atlanta. GA 30333 (telephone (404) 633~5313). I=5 Rem The Director, Center for Disease Control. may approve vanatio~u from the requirements of this section if, upon renew and evaluation, it is found that such variatiotu provide protection at least equivalent to that provided by compliance with the reqliirements specified in this section and such findin8e are made a matter of official record. FR Doc. #~217S7 Ad ,-1~ .. ~1 ~0 COO 4110_ - Effective August 20, 1980

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204 APPENDIX E Notice to Carrier Label (CDC) NOTICE TO CARRIER This package contains LESS THAN 50 ml OF AN ETIOLOGIC AGENT N.O.S., is packaged and labeled in accordance with the U. ~ Public Health Service Interstate Quarantine Regulations (42 CFR, Section 72.25(c), (1) and (4), and MEETS ALL REQUIRE- lIENTS FOR SHIPMI NT BY MAIL AND ON PASSENGER AIRCRAFT . This shipment is EXEMPTED FROM ATA RESTRICT-ED ARTICLES TARIFF 6-D (see General Requirements 386(d) (1) and from DOT HAZARDOUS MATERIALS REGULATIONS (see 49 CFR, Section 173, 386(d) (3). SHIPPER'S CERTIFICATES, SHIPPING PAPERS, AND OTHER DOCUMENTATION OR LABELING ARE NOT REQUIRED. Date c Signature of Shipper CENTER FOR DISEASE CONTROL All ANTA, GEORGIA 30333