[Federal Register Volume 61, Number 112 (Monday, June 10, 1996)]
[Proposed Rules]
[Pages 29327-29333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14707]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 72
RIN 0905-AE70
Additional Requirements for Facilities Transferring or Receiving
Select Infectious Agents
AGENCY: Centers for Disease Control and Prevention (CDC), Public Health
Service (PHS), Department of Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking.
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SUMMARY: This proposed rule is being promulgated in accordance with
Section
[[Page 29328]]
511 of Public Law 104-132, ``The Antiterrorism and Effective Death
Penalty Act of 1996,'' (enacted April 24, 1996) which requires such a
proposal be issued within 60 days of enactment and a final rule not
later than 120 days of enactment. CDC proposes this rule to place
additional shipping and handling requirements on laboratory facilities
that transfer or receive select infectious agents capable of causing
substantial harm to human health. CDC is concerned about the
possibility that the interstate transportation of certain infectious
agents could have adverse health consequences for human health and
safety. These requirements apply to laboratory facilities such as those
operated by government agencies, universities, research institutions,
and commercial entities. Those facilities requesting select infectious
agents listed in the regulation must register with the Secretary of
HHS, or with registering entities authorized by the Secretary, as
capable and equipped to handle the select infectious agents in
accordance with requirements developed by CDC, the National Institutes
for Health (NIH), and the Department of Defense.
DATES: Written comments must be received on or before July 10, 1996.
Written comments on the proposed information collection requirements
should also be submitted on or before July 10, 1996.
ADDRESSES: Mail written comments to the following address: Lynn Myers,
Office of Health and Safety, Centers for Disease Control and
Prevention, 1600 Clifton Road, Atlanta, GA 30333; telephone (404) 639-
2453 or 639-3235. Mail written comments on the proposed information
collection requirements to: Office of Information and Regulatory
Affairs, OMB, New Executive Office Bldg., 725 17th Street, NW, rm.
10235, Washington, DC 20503, Attn: Desk Officer for CDC.
Copies: To order copies of the Federal Register containing this
document, send your request to: New orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose a Visa or MasterCard number
and expiration date. Credit card orders can also be placed by calling
the order desk at (202) 512-1800 or by faxing to (202) 512-2250. The
cost of each copy is $8.00. As an alternative, you can view and
photocopy the Federal Register document at most libraries designated as
Federal Depository Libraries and at many other public and private
libraries throughout the country that receive the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Dr. Stephen Morse, National Center for Infectious Diseases, Centers for
Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30333;
telephone (404) 639-3222.
SUPPLEMENTARY INFORMATION: The current rules found at 42 C.F.R. Part 72
were last updated in 1980 and contain specific requirements for the
packaging, labeling, and transport of infectious agents shipped in
interstate commerce. That regulation does not currently contain
provisions restricting parties who may transfer these agents. This
proposed rule is designed to ensure that select infectious agents are
not shipped to parties who are not equipped to handle them
appropriately, or who otherwise lack proper authorization for their
requests, and to implement a system whereby scientists in research
institutions may continue transferring and receiving these agents
without undue burdens.
I. Background
In recent years, the threat of illegitimate use of infectious
agents has attracted increasing interest from the perspective of public
health. CDC is concerned about the possibility that the interstate
transportation of certain infectious agents could have adverse
consequences for human health and safety. CDC has already requested
that all those entities that ship dangerous human infectious agents
exercise increased vigilance prior to shipment to minimize the risk of
illicit access to infectious agents. Of special concern are pathogens
and toxins causing anthrax, botulism, brucellosis, plague, Q fever,
tularemia, and all agents classified for work at Biosafety level 4.
In particular, CDC has already requested that potential providers
of these agents carefully and thoroughly review all requests before
transferring these agents. This March, 1996, CDC request for voluntary
safeguards has been a first step in strengthening regulatory and
statutory protections in this area.
II. Proposed Rule
In accordance with Section 511 of Public Law 104-132, ``The
Antiterrorism and Effective Death Penalty Act of 1996,'' CDC is
proposing new regulations regarding acquisition and transfer of select
infectious agents. These proposed regulations have been developed with
input from professional associations, the research community, law
enforcement authorities, and concerned members of the public. It is
anticipated that most facilities transferring these agents are engaged
in activities consisting of interstate commerce, thus subjecting both
intrastate and interstate transfers made by such facilities to this
regulation. In addition, because these agents have the potential for
causing mass destruction or widespread disease in humans, CDC has
determined intrastate transfers of these agents from one geographical
site to another also pose a risk of potential interstate transmission
of disease; therefore, intrastate transfers of these agents are also
subject to the regulation. Transfers within a single facility at a
single geographical site, however, are not subject to this regulation
provided, that the intended use of the agent remains consistent with
that specified in the most current transfer form. Facilities that
receive select infectious agents are responsible for implementing their
own tracking mechanisms of intra-facility transfers of agents within a
single geographical site.
The proposed rule is based upon the key principles of ensuring that
the public safety is protected without encumbering legitimate
scientific and medical research. In addition, the proposed rule focuses
on strengthening public-private sector accountability through
involvement with professional associations and close coordination with
the research community actually handling these agents. Such
relationships, combined with expanded federal criminal sanctions,
minimize the need for an additional, expansive federal regulatory
structure.
Specifically, the rule is designed to:
collect and provide information concerning the location
where certain potentially-hazardous infectious agents are transferred;
track the acquisition and transfer of these specific
infectious agents; and
establish a process for alerting appropriate authorities
if an unauthorized attempt is made to acquire these agents.
The proposed rule is premised upon the following fundamental
components: (1) A comprehensive list of select infectious agents; (2) a
registration of facilities transferring these agents; (3) transfer
requirements; (4) verification procedures including audit, quality
control, and accountability mechanisms; (5) agent disposal
requirements; and (6) research and clinical exemptions.
III. Select Infectious Agents List
The proposed list of select infectious agents (Appendix A) was
originally developed from agents placed on the ``Australia list'' (15
C.F.R. Part 799.1,
[[Page 29329]]
Supplement No. 1, Export Control Classification Number 1C61B) of
selected infectious agents whose export from the U.S. is controlled due
to their capacity for causing substantial harm to human health. After
consultation with experts representing affected professional groups,
the proposed list now includes those agents provided in Appendix A. CDC
will continue consultation with these groups and update the list as
necessary. Future updates will be published in the Federal Register for
public review and comment. Comments are specifically solicited
regarding those agents included or not included on this proposed list.
IV. Registration of Facilities Transferring Select Infectious
Agents
Commercial suppliers of these select infectious agents, as well as
government agencies, universities, research institutions, individuals
and private companies that transfer or obtain these agents, or that
wish to work with these agents, must register with the Secretary of HHS
or with an organization authorized by the Secretary. Registration
requires that a responsible facility official certify that the facility
and its laboratory operations meet the biosafety level 2, 3, and/or 4
requirements for working with infectious agents as described in the
Third Edition of ``CDC/NIH Biosafety in Microbiological and Biomedical
Laboratories.'' Inspection of the facility seeking registration may be
required by the Secretary or an organization authorized by the
Secretary to determine whether the applicant facility meets the
appropriate biosafety level requirements. In return for the
certification and a site registration fee, facilities will be issued a
unique registration number by the Secretary or the registering entity
indicating that the facility is registered to work with these select
infectious agents at the prescribed biosafety level. The registration
number will then be used to help validate all requests for transfer of
these agents.
Registration requests may be denied if the Secretary or the
registering entity determines that the applicant facility is not able
to comply with any provision of the regulation. Registrations may be
withdrawn by the Secretary or registering entity for failure to comply
with the regulation or if it is determined that a registered facility
can no longer handle agents at the appropriate biosafety level or
handles agents in a manner that appears intended to harm the health of
humans. Withdrawals and denials will be based upon sufficient evidence
in the discretion the Secretary or registering entity. Any withdrawal
or denial may be appealed to the Secretary.
V. Transfer Requirements
Prior to transferring one of these select infectious agents, the
proposed rule requires both the shipping (transferor) and receiving
(requestor) parties to initiate completion of an approved transfer
form. Completion of the form is finalized when the requestor
acknowledges receipt of the requested agent. The form includes the list
of these restricted agents and requires information about the
requestor, transferor, the requesting and transferring facilities,
their registration numbers, the restricted agent requested, and the
proposed use of the agent. The form must accompany the request or
purchase order for obtaining these restricted agents, a copy must be
maintained by both the requesting and transferring facility, and a copy
must be sent to a designated central repository which would be
available to Federal and authorized local law enforcement authorities
and other officials authorized by the Secretary. The form could later
be used for tracking purposes in case of illegitimate access to these
agents. Falsification of this form is a Federal criminal offense.
VI. Verification Procedures
To facilitate the shipment of these select infectious agents, each
facility shipping or receiving a covered agent must have a
``responsible facility official.'' This person should be either a
biosafety officer, a senior management official of the facility, or
both. The responsible facility official should not be the same person
as those individuals actually transferring and receiving the agents at
the facilities.
The requestor's responsible facility official must sign each
request, certifying that the individual researcher requesting the agent
is officially affiliated with the facility and that the laboratory
meets current CDC/NIH Guidelines for working with the requested agent.
The responsible facility official sending the restricted agent is
required to verify that the receiving facility holds a currently valid
registration number, indicating that the recipient has the required
biosafety level capability. Inability to validate the necessary
information may result in immediate notification of the appropriate
authorities.
After transfer of the agent, receipt must be acknowledged by the
recipient to the transferor electronically or telephonically within 24
hours, followed by a paper copy of receipt within 3 business days of
receiving the agent. Copies of the completed transfer form must be
retained by both the requestor's and transferor's facilities for a
period of five (5) years after the date of shipment or for one (1) year
after the agents are properly disposed, whichever is longer, and one
copy must be sent to the transferor's authorized registering entity for
placement in a centralized repository.
VII. Agent Disposal Requirements
The form requires a signed statement that the agents will be stored
in accordance with prudent laboratory practices, destroyed after
completion of the work, or transferred to an approved repository.
Facilities must have in place procedures for the appropriate disposal
of agents.
VIII. Research and Clinical Exemptions
In order to provide strains for reference diagnostic and research
studies at Biosafety Level 2 facilities, less pathogenic strains of
restricted viral agents as described in the CDC/NIH ``Biosafety in
Microbiological and biomedical Laboratories'' manual or those
specifically mentioned on the new CDC Form EA-101 are exempt from the
list of select infectious agents. Toxins for medical use, inactivated
for used as vaccines, or preparations for biomedical research use at an
LD50 for vertebrates of more than 100 nanograms per kilogram of
body weight, are exempt. Transfer of clinical specimens for diagnostic
and verification purposes is also exempt. However, isolates of these
agents from clinical specimens must be destroyed after confirmation or
sent to an approved repository after diagnostic procedures are
complete. Other than for these purposes, such isolates may not be
transferred to another site without using the transfer form and
approval by the responsible facility officials.
IX. Criminal and Civil Penalties
Violations of proposed 42 C.F.R. Part 72 are subject to criminal
penalties as prescribed in 42 U.S.C. 271 and 18 U.S.C. 3559 and 3571.
Specifically, individuals in violation of this rule are subject to a
fine of no more than $250,000 or one more year in jail, or both.
Violations by organizations are currently subject to a fine no greater
than $500,000 per event. A false, fictitious, fraudulent statement or
representation on the forms required in the regulation for registration
of facilities or for transfers of select agents is subject to a fine or
imprisonment for not more than five years, or both, for an individual;
and a fine for an organization. 18 U.S.C. 1001, 3517.
[[Page 29330]]
X. Public Comment
Public comment is solicited on all aspects of this proposed
amendment to the CDC regulation, ``Interstate Shipment of Etiologic
Agents,'' 42 C.F.R. Part 72. In addition, CDC solicits comments on the
following items:
(1) The list of select infectious agents covered by this proposed
rule (see Appendix A);
(2) The names of organizations that would be candidates to be
authorized by the Secretary as a ``registering entity'' to determine
those facilities that are capable of handling the agents covered by
this regulation;
(3) The names and addresses of all facilities with biosafety level
capacity that may handle these agents; and
(4) The utility of conducting mandatory preregistration inspections
of all applicant facilities versus random or for cause preregistration
inspections conducted in the discretion of the registering entity or
the Secretary.
(5) The advantages or disadvantages of the Secretary or registering
entity sending copies of transfer forms to the applicable state health
departments.
We are not able to acknowledge or respond to comments individually.
We will consider all comments we receive by the date and time specified
in the DATES section of this preamble, and, if we proceed with a
subsequent document, we will respond to the comments in the preamble to
the document. In addition, all commenters are advised that, pursuant to
the Administrative Procedure Act, all information provided to CDC in
response to this request for comment will be publicly available.
XI. Analysis of Impacts
A. Review Under Executive Order 12866, Sections 202 and 205 of the
Unfunded mandate Reform Act of 1995 (P.L. 104-4), and by the Regulatory
Flexibility Act (5 USC 603-605)
The Department has examined the potential impact of this proposed
rule as directed by Executive Order 12866, by sections 202 and 205 of
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4, and by the
Regulatory Flexibility Act (5 U.S.C. 603-605).
Executive Order 12866 directs agencies to assess the costs and
benefits of available regulatory alternatives, and, when regulation is
necessary, to select regulatory approaches that maximize net benefits.
This proposed rule is designed to ensure that select infectious agents
are not shipped to parties who are not equipped to handle them
appropriately or who otherwise lack proper authorization for their
requests. The approach selected decentralizes the oversight process for
this purpose, imposes minimal administrative costs, and prevents
possible serious, harmful effects to public safety and health. (The
proposal has been reviewed by the Office of Management and Budget under
the terms of the Executive Order.)
The Unfunded Mandates Reform Act of 1995, in sections 202 and 205,
requires that agencies prepare several analytic statements before
proposing a rule that may result in annual expenditures by State, local
and tribal governments, or by the private sector, of $100 million. As
any final rule resulting from this proposal would not result in
expenditures of this magnitude, such statements are not necessary.
The Regulatory Flexibility Act requires agencies to prepare a
regulatory flexibility analysis, describing the impact of the proposed
rules on small entities, but also permits agency heads to certify that
a proposed rule will not, if promulgated, have a significant economic
impact on a substantial number of small entities. The Secretary hereby
has determined that this proposed rule would not have such impact, as
it would primarily affect large research institutions.
B. Review under the Paperwork Reduction Act of 1995
The proposed rule contains information collection requirements
which are subject to review by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. The title, description
and respondent description of the information collection are shown
below with an estimate of the annual reporting burden. Included in the
estimate is the time for reviewing instructions, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. With respect to the following collection of
information, CDC invites comments on: (a) Whether the proposed
collection of information is necessary for the proper performance of
CDC's functions, including whether the information shall have practical
utility; (b) the accuracy of CDC's estimate of the burden of the
proposed collection of information including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automatic collection techniques for other
forms of information technology.
Title: Additional Requirements for Facilities Transferring or
Receiving Select Infectious Agents.
Description: The Antiterrorism and Effective Death Penalty Act of
1996 (Public Law 104-132) authorizes the Secretary of Health and Human
Services (HHS) to regulate the transfer of certain infectious agents
harmful to humans. The Centers for Disease Control and Prevention (CDC)
is the agency within the Department responsible for promulgating this
regulation. CDC is proposing a rule designed to ensure that select
infectious agents are not shipped to parties who are not equipped to
handle them appropriately, or who otherwise lack proper authorization
for their requests, and to implement a system whereby scientists in
research institutions may continue transferring and receiving these
agents without undue burdens. Respondents include laboratory facilities
such as those operated by government agencies, universities, research
institutions, and commercial entities.
Those facilities requesting select infectious agents listed in the
regulation must register with the Secretary of HHS, or with registering
entities authorized by the Secretary, as capable and equipped to handle
the select infectious agents in accordance with requirements developed
by CDC, the National Institutes for Health (NIH) and the Department of
Defense.
Title: Additional Requirements for Facilities Transferring or
Receiving Select Infectious Agents
Description: The Autiterrorism and Effective Death Penalty Act of
1996 (Public Law 104-132) authorizes the Secretary of Health and Human
Services (HHS) to regulate the transfer of certain infectious agents
harmful to humans. The Centers for Disease Control and Prevention (CDC)
is the agency within the Department responsible for promulgating this
regulation. CDC is proposing a rule designed to ensure that select
infectious agents are not shipped to parties who are not equipped to
handle them appropriately, or who otherwise lack proper authorization
for their requests, and to implement a system whereby scientists in
research institutions may continue transferring and receiving these
agents without undue burdens. Respondents include laboratory facilities
such as those operated by government agencies, universities, research
institutions, and commercial entities.
Those facilities requesting select infectious agents listed in the
regulation must register with the Secretary of HHS, or with registering
entities authorized by the Secretary, as capable and
[[Page 29331]]
equipped to handle the select infectious agents in accordance with
requirements developed by CDC, the National Institutes for Health (NIH)
and the Department of Defense.
Once registered, facilities must complete a federally-developed
form, CDC Form EA-101, for each transfer of an agent covered by this
proposed rule. Information on this form will include the name of the
requestor and requesting facility, the name of the transferor and
transferring facility, the name of the responsible facility official
for the transferor and requestor, the requesting facility's
registration number, the transferring facility's registration number,
the name of the agent(s) being shipped, and the proposed use of the
agent. The package is being revised to include the burden for
laboratories to register with the Secretary.
Description of Respondents: Commercial suppliers of these select
infectious agents, as well as government agencies, universities,
research institutions, and private companies that transfer or obtain
these agents, or that wish to work with these agents.
Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
No. of Frequency of Total annual Hour per
CFR section respondents responses responses response Total hours
----------------------------------------------------------------------------------------------------------------
72.6(a)......................... 1,000 1 1,000 .25 250
72.6(d)......................... 1,000 3 3,000 1.05 3,150
72.6(e)......................... 120 21 2,520 .17 428
72.6(f)......................... 1,000 3 3,000 .11 330
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Total....................... 4,158
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Reporting or Disclosures: These estimates are an approximation of
the average time expected to be necessary for a collection of
information. They are based on past experience of respondents reporting
such information to CDC. There are no capital costs or operating and
maintenance costs for the respondents associated with this information
collection.
The agency has submitted a copy of this proposed rule to OMB for
its review of these information collection. Interested persons are
requested to send comments regarding this information collection,
including suggestions for reducing the burden, to the Office of
Information and Regulatory Affairs, OMB, New Executive Office Bldg.,
725 17th Street, NW., rm 10235, Washington, DC 20503, Attn: Desk
Officer for CDC. Submit written comments on the information collection
by July 10, 1996.
List of Subjects in 42 CFR Part 72
Biologics, Packaging and containers, Transportation.
Dated: May 16, 1996.
David Satcher,
Director, Centers for Disease Control and Prevention.
Dated: May 28, 1996.
Donna E. Shalala,
Secretary, Department of Health and Human Services.
For the reasons set out in the preamble, it is proposed to amend 42
CFR Chapter 1 as follows:
PART 72--INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS
1. The authority citation for Part 72 is revised to read as
follows:
Authority: 42 U.S.C. 264, 271; 31 U.S.C. 9701; 18 U.S.C. 3559,
3571; Public Law 104-132.
2. Sections 72.6 and 72.7 are added to read as follows:
Sec. 72.6 Additional requirements for facilities transferring or
receiving select infectious agents.
(a) Registration of facilities. (1) Prior to transferring or
receiving a select infectious agent listed in Appendix A of this part,
a laboratory 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 (BSL) 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 BSL 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.
(5) The requirements for BSL-2, 3, and 4 operations pertaining to
this section are contained in the CDC/NIH publication, ``Biosafety in
Microbiological and Biomedical Laboratories,'' Third Edition, May 1993
which is hereby incorporated by reference. To the extent the document
and this part are inconsistent, the part shall control.
(6) Additional specific requirements for handling toxins subject to
this part must be met and are found in 32 CFR 627.17 and in The
Biological Defense
[[Page 29332]]
Safety Program, Technical Safety Requirements (DA Pamphlet 385-69),
Subpart C--Operational Requirements.
(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 infectious agents are consistent with
the requirements contained in the CDC/NIH publication ``Biosafety in
Microbiological and Biomedical Laboratories,'' Third Edition.
(2) A registering entity shall maintain:
(i) A database of all facilities formerly and currently registered
as BSL 2, 3, or 4 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 representative. The database shall remain publicly available.
(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
paragraph (c)(2) of this section.
(d) Requests for infectious agents. (1) Prior to the transfer of
any infectious 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 transferror 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; and
(vii) The proposed use of the agent(s).
(2) The form must be signed by the transferror and requestor, and
the responsible facility officials representing both the transferring
and requesting facilities. A copy of the completed CDC From 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 one (1) year after
the agents are properly disposed, whichever is longer. 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 transferror'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 officially affiliated with 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 and the appropriate law enforcement
authorities.
(f) Transfer. (1) Upon completion of the CDC Form EA-101 and
verification of registration, the transferring facility must ship the
agents in accordance with packaging and shipping requirements in this
part or other applicable regulations.
(2) The requesting facility's responsible official must acknowledge
receipt of the agent telephonically or otherwise electronically within
24 hours of receipt and provide a paper copy of receipt to the
transferror within 3 business days of receipt of the agent.
(3) Upon telephonic acknowledgment of receipt of the agent, the
transferor shall provide a completed copy of CDC Form EA-101 within 24
hours to the registering entity (holding that facility's registration),
in accordance with paragraph (c)(2) of this section 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
intra-facility transfers not subject to this part 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 paragraph (c)(3) of this section, to assure compliance
with this part.
(h) Exemptions. Select infectious agents otherwise covered by this
part are exempt from its provisions if:
(1) The agent(s) are less pathogenic strains which can be used for
reference diagnostic or verification procedures and/or research studies
at BSL-2, or lower, as described in the CDC/NIH publication,
``Biosafety in Microbiological and Biomedical Laboratories,'' Third
Edition; or
(2) The agent is part of a clinical specimen intended for
diagnostic and/or reference verification purposes. Isolates of covered
agents from clinical specimens shall be disposed of in accordance with
paragraph (i) of this section after diagnostic procedures have been
completed.
(3) 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.
(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
destroyed, the
[[Page 29333]]
responsible facility official must formally notify the registering
entity. A copy of such formal notification must be 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, partnerhship, society, association, firm, or
other legal entity located at a single geographical site that may
transfer or receive through any means a select infectious 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
infectious 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 infectious agent subject to this part from any other
person.
Responsible facility official means an official authorized to
transfer and receive select infectious agents covered by this part on
behalf of the transferor's and/or requestor's facility. This person
should be either a biosafety 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 infectious agent means an agent, virus, bacteria, fungi,
rickettsiae or toxin listed in Appendix A of this part. The term also
includes genetically modified microorganisms or genetic elements that
contain nucleic acid sequences associated with pathogenicity from
organisms on Appendix A, and genetically modified microorganisms on
Appendix A, and genetically modified microorganisms or genetic elements
that contain nucleic acid sequences coding for any of the toxins in
Appendix A, or their toxic subunits.
Transfer (a) means the conveyance or movement from a point of
origination to a point of destination either
(1) From one state or territory to another or
(2) Entirely within one contiguous state or territory.
(b) The term does not include intra-facility conveyances within a
facility located at a single geographical site provided, that the
intended use of the agent remains consistent with that specified in the
most current transfer form.
Transferor means any person who transfers or seeks to transfer
through any means a select infectious agent subject to this part to any
other person.
Sec. 72.7 Penalties.
Individuals in violation of this part are subject to a fine of no
more than $250,000 or one year in jail, or both. Violations by
organizations are subject to a fine of no more than $500,000 per event.
A false, fictitious, or fraudulent statement or representation on the
Government forms required in the part for registration of facilities or
for transfers of select agents is subject to a fine or imprisonment for
not more than five years, or both for an individual; and a fine for an
organization.
Appendix A to Part 72--Select Infectious Agents
Viruses
1. Crimean-Congo haemorrhagic fever virus
2. Chikungunya virus
3. Ebola virus
4. Hantaviruses
5. Japanese encephalitis virsus
6. Lassa fever virus
7. Marburg virus
8. Rift Valley fever virus
9. Tick-borne encephalitis viruses
10. Variola major virus (Smallpox virus)
11. Yellow fever virus
12. South American Haemorrhagic fever viruses (Junin, Machupo,
Sabia, Guanarito, and those yet to be decribed)
13. Encephalitis viruses (Venezuelan, Western, Eastern)
14. Kyasanur Forest Disease virus
Exemptions: Vaccine strains of these viral agents as described
in the third edition of the CDC/NIH ``Biosafety in Microbiological
and Biomedical Laboratories'' are exempt.
Bacteria*
1. Bacillus anthracis
2. Brucella abortus, B. melitensis, B. suis
3. Chlamydia psittaci
4. Clostridium botulinum
5. Francisella tularensis
6. Burkholderia (Pseudomonas) mallei
7. Burkholderia (Pseudomonas) pseudomallei
8. Yersinia pestis
Rickettsiae*
1. Coxiella burnetii
2. Rickettsia prowazekii
3. Rickettsia rickettsii
Fungi
1. Histoplasma capsulatum (incl. var duboisii)
Toxins
1. Abrin
2. Botulinum toxins
3. Clostridium perfringens toxin
4. Corynebacterium diphtheriae toxin
5. Cyanginosins
6. Staphylococcal enterotoxins
7. Shigella dysenteriae neurotoxin
8. Ricin
9. Saxitoxin
10. Shigatoxin
11. Tetanus toxin
12. Tetrodotoxin
13. Trichothecene mycotoxins
14. Verrucologen
Exemptions: Toxins for medical use, inactivated for use as
vaccines, or toxin preparations for biomedical research use at an
LD50 for vertebrates of more than 100 nanograms per kilogram
body weight (e.g., microbial toxins such as the botulinum toxins,
tetanus toxin, diphtheria toxin, and Shigella dysenteriae
neurotoxin) are exempt.
Recombinant organisms/molecules
1. Genetically modified microorganisms or genetic elements that
contain nucleic acid sequences associated with pathogenicity from
organisms on restricted list.
2. Genetically modified microorganisms or genetic elements tht
contain nucleic acid sequences coding for any of the toxins on the
restricted list, or their toxic subunits.
* The deliberate transfer of a drug resistance trait to
microorganisms on this list that are not know to acquire the trait
naturally is prohibited by HIH ``Guidelines for Research Involving
Recombinant DNA Molecules,'' if such acquisition could compromise
the use of the drug to control these disease agents in humans or
veterinary medicine.
[FR Doc. 96-14707 Filed 6-7-96; 8:45 am]
BILLING CODE 4160-18-M
