[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR72.6]
[Page 441-445]
TITLE 42--PUBLIC HEALTH
CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 72_INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS \1\--Table of Contents
Sec. 72.6 Additional requirements for facilities transferring or
receiving select agents.
(a) Registration of facilities. (1) Prior to transferring or
receiving a select agent listed in Appendix A of this part, a facility
shall register with a registering entity authorized by the Secretary
(paragraph (c) of this section) or be approved by the Secretary as
equipped and capable of handling the covered agent at Biosafety Level
(BL) 2, 3, or 4, depending on the agent.
(2) Registration will include:
(i) Sufficient information provided by the responsible facility
official indicating that the applicant facility, and its laboratory or
laboratories, are equipped and capable of handling the agents at BL 2,
3, or 4, depending upon the agent, and the type of work being performed
with the agents;
(ii) Inspection of the applicant facility at the discretion of the
Secretary or the registering entity in consultation with the Secretary;
(iii) Issuance by the registering entity of a registration number
unique to each facility;
(iv) Collection of a periodic site registration fee by the
registering entity or the Secretary.
A schedule of fees collected by the Secretary to cover the direct
costs (e.g., salaries, equipment, travel) and indirect costs (e.g.,
rent, telephone service and a proportionate share of management and
administration costs) related to administration of this part will be
published in the Federal Register and updated annually.
(v) Follow-up inspections of the facility by the registering entity
or the Secretary, as appropriate, to ensure the facility continues to
meet approved standards and recordkeeping requirements.
(3) Such registration shall remain effective until relinquished by
the facility or withdrawn by the Secretary or the registering entity.
(4) The registration may be denied or withdrawn by the registering
entity or the Secretary based on:
(i) Evidence that the facility is not or is no longer capable of
handling covered agents at the applicable biosafety level;
(ii) Evidence that the facility has handled covered agents in a
manner in contravention of the applicable biosafety level requirements;
(iii) Evidence that the facility has or intends to use covered
agents in a manner harmful to the health of humans;
(iv) Evidence that the facility has failed to comply with any
provisions of this part or has acted in a manner in contravention of
this part; or
(v) Failure to pay any required registration fee.
[[Page 442]]
(5) The biosafety standards and requirements for BSL-2, 3, and 4
operations are contained in the CDC/NIH publication, ``Biosafety in
Microbiological and Biomedical Laboratories,'' Fourth Edition, May 1999
which is hereby incorporated by reference. The Director of the Federal
Register has approved under 5 U.S.C. 552(a) and 1 CFR part 51 the
incorporation by reference of the above publication. Copies may be
obtained from the Superintendent of Documents, U.S. Government Printing
Office, Washington, DC 20402. Copies may be inspected at the Centers for
Disease Control and Prevention, 1600 Clifton Road, Mail Stop A-13
Atlanta, Georgia, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html. The manual is also
available on the CDC web site at www.cdc.gov/od/ohs/biosfty/bmbl4/
bmbl4toc.htm.
(6) Additional specific requirements for handling toxins subject to
this part must be met and are found in 29 CFR Sec. 1910.1450,
``Occupational Exposure to Hazardous Chemicals in Laboratories.''
(b) Appeals. A decision made by the Secretary or a registering
entity to deny or withdraw registration of a particular facility may be
appealed to the Secretary. An application for appeal must be received by
the Secretary no later than 14 days after the appealing party's
application for registration was denied or no later than 14 days after
the appealing party's registration was withdrawn. The application must
clearly identify the issues presented by the appeal and fully explain
the appealing party's position with respect to those issues. The
Secretary may allow the filing of opposing briefs, informal conferences,
or whatever steps the Secretary considers appropriate to fairly resolve
the appeal.
(c) Authorized registering entities. (1) the Secretary may authorize
a state agency or private entity to register facilities under paragraph
(a) of this section, if the Secretary determines that the registering
entity's criteria for determining the biosafety standards for facilities
handling select agents are consistent with the requirements contained in
the CDC/NIH publication ``Biosafety in Microbiological and Biomedical
Laboratories,'' Fourth Edition.
(2) A registering entity shall maintain:
(i) A database of all facilities formerly and currently registered
as BL 2, 3, or 4 and capable of working with agents in Appendix A of
this part. The database shall include the name and address of the
registered facility, the date the facility was registered, the
facility's registration number, and the name and phone number of the
responsible facility official.
(ii) A copy of each CDC Form EA-101 transmitted by each transferor
registered by that registering entity. Such forms shall be made readily
accessible to the Secretary and to appropriate federal law enforcement
authorities and/or authorized local law enforcement authorities.
(3) In the event the Secretary authorizes more than one registering
entity, or if otherwise necessary, the Secretary may require the
establishment of a consolidated database to carry out the provisions of
Sec. 72.6(c)(2).
(d) Requests for agents. (1) Prior to the transfer of any agent
contained in Appendix A of this part, a CDC Form EA-101 must be
completed for each transfer sought. As specified in CDC Form EA-101, the
information provided must include:
(i) The name of the requestor and requesting facility;
(ii) The name of the transferor and transferring facility;
(iii) The names of the responsible facility officials for both the
transferor and requestor;
(iv) The requesting facility's registration number;
(v) The transferring facility's registration number;
(vi) The name of the agent(s) being shipped;
(vii) The proposed use of the agent(s); and
(viii) The quantity (number of containers and amount per container)
of the agent(s) being shipped.
(2) The form must be signed by the transferor and requestor, and the
responsible facility officials representing
[[Page 443]]
both the transferring and requesting facilities.
(3) A copy of the completed CDC Form EA-101 must be retained by both
transferring and requesting facilities for a period of five (5) years
after the date of shipment or for five (5) years after the agents are
consumed or properly disposed, whichever is longer.
(4) All CDC forms EA-101 must be produced upon request to
appropriate federal and authorized local law enforcement authorities,
officials authorized by the Secretary, and officials of the registering
entity.
(e) Verification of registration. (1) Prior to transferring any
agent covered by this part, the transferor's responsible facility
official must verify with the requestor's responsible facility official,
and as appropriate, with the registering entity:
(i) That the requesting facility retains a valid, current
registration;
(ii) That the requestor is an employee of the requesting facility;
and
(iii) That the proposed use of the agent by the requestor is
correctly indicated on CDC Form EA-101.
(2) In the event that any party is unable to verify the information
required in paragraph (e)(1) of this section, or there is suspicion that
the agent may not be used for the requested purpose, then the party
shall immediately notify CDC.
(f) Transfer. (1) Upon completion of the CDC Form EA-101 and
verification of registration, the transferring facility must comply with
the packaging and shipping requirements in this part or other applicable
regulations when transferring the agent.
(2) The requesting facility's responsible official must acknowledge
receipt of the agent telephonically or otherwise electronically within
36 hours of receipt and provide a paper copy or facsimile transmission
of receipt to the transferor within 3 business days of receipt of the
agent.
(3) Upon telephonic acknowledgment of receipt of the agent, the
transferor shall provide a completed paper copy or facsimile
transmission of CDC Form EA-101 within 24 hours to the registering
entity (holding that facility's registration), in accordance with Sec.
72.6(c)(2) for filing in a centralized repository.
(g) Inspections. (1) Registering entities or the Secretary may
conduct random or for cause inspections of registered facilities to
assure compliance with this part. All CDC forms EA-101 and records
deemed relevant by inspecting officials must be produced upon request to
authorized personnel conducting these inspections. Inspections may also
include review of the mechanisms developed by a facility to track
intrafacility transfers as well as the facility's agent disposal
procedures.
(2) In addition, the Secretary may conduct inspections of
registering entities, and/or any consolidated database established in
accordance with Sec. 72.6(c)(3), to assure compliance with this part.
(h) Exemptions--(1) Exemptions for certain select agents: Select
agents otherwise covered by this part are exempt from its provisions if:
(i) The agent is part of a clinical specimen intended for
diagnostic, reference, or verification purposes. Isolates of covered
agents from clinical specimens shall be disposed of in accordance with
Sec. 72.6(i) after diagnostic, reference, or verification procedures
have been completed;
(ii) The agent is a toxin having an LD50 for vertebrates
of more than 100 nanograms per kilogram of body weight which is used for
legitimate medical purposes or biomedical research or is one of the
listed toxins which has been inactivated for use as a vaccine or
otherwise detoxified for use in biomedical research procedures; or
(iii) The agent(s) is an exempted strain specified in Appendix A of
this part and/or CDC Form EA-101. Additional exemptions for otherwise
covered strains will be considered when CDC reviews and updates the list
of select agents (Appendix A of this part). Individuals seeking
additions to the list of exemptions should submit a request to CDC that
specifies the agent or strain to be exempted and explains why such an
exemption should be granted. Future changes to the list of exemptions
will be published in the
[[Page 444]]
Federal Register for review and comment prior to inclusion on Appendix A
of this part.
(2) Exemption of CLIA certified laboratories: Clinical laboratories
certified under the Clinical Laboratory Improvement Amendments of 1988,
(42 U.S.C. 263a) (CLIA), that utilize these select agents for
diagnostic, reference, verification, or proficiency testing purposes are
exempt from the provisions of Sec. 72.6.
(3) Procedures for facilities that are not CLIA laboratories but are
transferring or receiving select agents to or from a CLIA laboratory:
Facilities that are not CLIA laboratories but are transferring or
receiving select agents to or from a CLIA laboratory must comply with
the following provisions. (No additional paperwork on behalf of CLIA
laboratories is required by this section.)
(i) Prior to transferring a select agent subject to this part to a
CLIA laboratory for diagnostic, reference, verification, or proficiency
testing purposes, the transferor must:
(A) Provide the following information on CDC Form EA-101:
(1) The name of the requestor and requesting facility;
(2) The name of the transferor and transferring facility;
(3) The name of the transferor's responsible facility official;
(4) The requesting facility's CLIA certification number (which the
transferor must verify as valid and current with the registering
entity);
(5) The transferring facility's registration number;
(6) The name of the agent(s) being shipped;
(7) The proposed use of the agent(s); and
(8) The quantity (number of containers and amount per container) of
the agent(s) being shipped.
(B) Verify receipt of the agent with the CLIA laboratory and note
such receipt on CDC Form EA-101;
(C) Transmit a copy of the form, signed by the transferror and the
responsible facility official representing the transfering facility, to
the registering entity holding the transferring facility's registration;
and
(D) Retain a copy of CDC Form EA-101 in accordance with Sec.
72.6(d)(3) and Sec. 72.6(d)(4).
(ii) Prior to receiving a select agent listed in Appendix A of this
part from a CLIA laboratory, the requestor must be registered in
accordance with Sec. 72.6(a) and comply with the following
requirements:
(A) Provide the following information on the CDC Form EA-101:
(1) The name of the requestor and requesting facility;
(2) The name of the transferor and transferring facility;
(3) The name of the requestor's responsible facility official;
(4) The transferring facility's CLIA certification number;
(5) The requesting facility's registration number;
(6) The name of the agent(s) being shipped;
(7) The proposed use of the agent(s); and
(8) The quantity (number of containers and amount per container) of
the agent(s) being shipped.
(B) Upon receiving the agent, note such receipt on CDC Form EA-101;
(C) Transmit a copy of CDC Form EA-101, signed by the requestor and
the responsible facility official representing the requesting facility,
to the registering entity holding the requesting facility's
registration;
(D) Retain a copy of the CDC Form EA-101 in accordance with
Sec. Sec. 72.6(d)(3) and 72.6(d)(4);
(E) Comply with the disposal requirements of Sec. 72.6(i) and all
other sections of this part when subsequently transferring the agent.
(i) Agent disposal. (1) Upon termination of the use of the agent,
all cultures and stocks of it will be
(i) Securely stored in accordance with prudent laboratory practices,
(ii) Transferred to another registered facility in accordance with
this part, or
(iii) Destroyed on-site by autoclaving, incineration, or another
recognized sterilization or neutralization process.
(2) When an agent, previously transferred to a facility in
accordance with this part, is consumed or destroyed, the responsible
facility official must formally notify the registering entity.
[[Page 445]]
Formal notification must be noted on CDC Form EA-101 and a copy kept on
record by the responsible facility official for a period of five (5)
years and is subject to paragraph (g) of this section.
(j) Definitions. As used in this section:
Facility means any individual or government agency, university,
corporation, company, partnership, society, association, firm, or other
legal entity located at a single geographic site that may transfer or
receive through any means a select agent subject to this part.
Registering entity means an organization or state agency authorized
by the Secretary to register facilities as capable of handling select
agents at Biosafety Level 2, 3, or 4, depending on the agent, in
accordance with the CDC/NIH publication ``Biosafety in Microbiological
and Biomedical Laboratories.''
Requestor means any person who receives or seeks to receive through
any means a select agent subject to this part from any other person.
Responsible facility official means an official authorized to
transfer and receive select agents covered by this part on behalf of the
transferor's and/or requestor's facility. This person should be either a
safety officer, a senior management official of the facility, or both.
The responsible facility official should not be an individual who
actually transfers or receives an agent at the facility.
Secretary means the Secretary of the Department of Health and Human
Services or her or his designee.
Select agent means a microorganism (virus, bacterium, fungus,
rickettsia) or toxin listed in Appendix A of this part. The term also
includes:
(1) Genetically modified microorganisms or genetic elements from
organisms on Appendix A of this part, shown to produce or encode for a
factor associated with a disease, and
(2) Genetically modified microorganisms or genetic elements that
contain nucleic acid sequences coding for any of the toxins on Appendix
A of this part, or their toxic submits.
Single geographic site means a building or complex of buildings at a
single mailing address.
Transfer means:
(1) The conveyance or movement from a point or origination to a
point of destination either:
(i) From one state or territory to another or;
(ii) Entirely within one contiguous state or territory.
(2) Intrafacility transfers within a registered facility located at
a single geographic site are not covered by the provisions of Sec. 72.6
(d), (e), and (f) provided that:
(i) The intended use of the agent remains consistent with that
specified in the most current transfer form; and
(ii) For each intrafacility transfer, the facility maintains records
that include the name and location of the recipient; the amount of agent
transferred, and the date transferred. Such records must be maintained
for a period of five (5) years after the date of transfer or for five
(5) years after the agents are consumed or properly disposed, whichever
is longer.
Transferor means any person who transfers or seeks to transfer
through any means a select agent subject to this part to any other
person.
[61 FR 55197, Oct. 24, 1996, as amended at 66 FR 45945, Aug. 31, 2001;
69 FR 18803, Apr. 9, 2004]