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OCR for page 187
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
OCR for page 188
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.
OCR for page 189
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.
OCR for page 190
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.
OCR for page 191
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
OCR for page 192
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
OCR for page 193
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
OCR for page 194
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
OCR for page 195
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
OCR for page 196
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.
OCR for page 197
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)
OCR for page 198
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.
OCR for page 199
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.
OCR for page 200
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
OCR for page 201
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)
-
OCR for page 202
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
OCR for page 203
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
OCR for page 204
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
Representative terms from entire chapter:
veterinary services
