Additional Requirements for Facilities Transferring or Receiving Select Infectious Agents

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

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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]

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