[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]



=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
                                 -------------------------------------------------------------------------------
    Total.......................                                                                           4,158
----------------------------------------------------------------------------------------------------------------

    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