Additional Requirements for Facilities Transferring or Receiving Select Agents

SUMMARY: On June 10, 1996, the Centers for Disease and Prevention

(CDC), the Department of Health and Human Services (HHS), issued a

Notice of Proposed Rulemaking (NPRM) to implement Section 511 of Public

Law 104-132, ``The Antiterrorism and Effective Death Penalty Act of

1996,'' which requires the Secretary of HHS to regulate the transfer of

select agents. CDC requested comments on the NPRM and provided 30 days

for individuals to submit their written comments. CDC considered the

comments received and is issuing this final regulation in light of

those comments. Current regulations specify requirements for the

packaging, labeling, and transport of select agents shipped in

interstate commerce. This final rule places additional shipping and

handling requirements on facilities that transfer or receive select

agents listed in the rule that are capable of causing substantial harm

to human health.

EFFECTIVE DATES: April 15, 1997, Incorporation by reference of certain

publications listed in the final rule is approved by the Director of

the Federal Register as of April 15, 1997. All transfers of select

agents must comply with the complete documentation and registration

requirements contained in this final rule on or after April 15, 1997.

CDC has already begun efforts to inform and educate affected parties

about the registration and transfer process for select agents. Within

the next 60 days, CDC anticipates providing additional detailed

information to interested parties in order to initiate the registration

process.

FOR FURTHER INFORMATION CONTACT: Dr. Jonathan Y. Richmond, Director,

Office of Health and Safety, Centers for Disease Control and

Prevention, 1600 Clifton Road, Mailstop F05, Atlanta, GA 30333;

telephone (404) 639-2453.

SUPPLEMENTARY INFORMATION: This rule finalizes the rule entitled

``Additional Requirements for Facilities Transferring or Receiving

Select Infectious Agents,'' which was published in the Federal Register

on June 10, 1996 (61 FR 29327). It has been retitled, ``Additional

Requirements for Facilities Transferring or Receiving Select Agents.''

Section 511 of Public Law 104-132, enacted on April 24, 1996,

stipulated that HHS issue a proposed regulation within 60 days and a

final regulation within 120 days. The NPRM was published on June 10 (13

days earlier than required) and provided 30 days for public review and

comment. The subject matter, and subsequent comments responding to the

NPRM, raised highly-complex issues that demanded careful consideration

and significant discussion with numerous other involved Federal

agencies. Thus, the publication of this final rule extended beyond 120

days.

BACKGROUND ON THE NOTICE OF PROPOSED RULEMAKING AND SUMMARY OF

RESPONSES TO PUBLIC COMMENT

Notice of Proposed Rulemaking

In recent years, the threat of illegitimate use of infectious

agents has attracted increasing interest from the perspective of public

health, in view of concern that certain select agents could have

serious adverse consequences for human health and safety. ``The

Antiterrorism and Effective Death Penalty Act of 1996,'' enacted on

April 24, 1996, established new provisions to regulate transfer of

hazardous agents, and required HHS to issue rules to implement these

provisions. CDC's NPRM proposed new regulations to meet the

requirements of this statute.

The NPRM was based on the key principles of ensuring protection of

public safety, without encumbering legitimate scientific and medical

research. The NPRM also was designed to minimize the need for an

additional, expansive federal regulatory implementation structure.

Specifically, the proposed rule was designed to:

Establish a system of safeguards to be followed when

specific agents are transported:

Collect and provide information concerning the location

where certain potentially-hazardous agents are transferred;

Track the acquisition and transfer of these specific

agents; and

Establish a process for alerting appropriate authorities

if an unauthorized attempt is made to acquire these agents.

The proposed rule included the following fundamental components:

(1) A comprehensive list of select 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.

Public Comment and Department's Response

During the 30-day comment period that ended on July 10, 1996, CDC

received sixty seven written responses. Most of these contained

multiple comments, some as many as 10 or more, with the total number of

comments exceeding two hundred. Most comments were favorable regarding

the proposed rule. In general, these comments focused on specific

sections of the regulation, requested clarification of the wording and

intended meaning of certain provisions, or suggested additions or

deletions to the proposed list of select agents. A small number of the

commenters expressed concern that the proposed regulation would not

protect against terrorism, would slow or discourage certain areas of

research, and/or would add unnecessary additional administrative costs

and paperwork burdens. The preamble sections below summarize the NPRM

and the comments received, and provide CDC's responses to comments.

Select Agents List

The NPRM included a proposed list of select agents to be subject to

the rule. CDC specifically solicited comments regarding those agents to

be added to or deleted from the proposed list. We received a large

number of responses to this request. The list of agents subject to the

final rule is at Appendix A.

Agents deleted from the list are Chikungunya virus, Japanese

encephalitis virus, Chlamydia psittaci, and Histoplasma capsulatum

(including var. duboisii). Infectious agents added to the final list

are Equine morbillivirus, and Coccidioides immitis. Kyasanur forest

disease virus is no longer specifically listed but is included under

the broader category of Tick-borne encephalitis complex viruses.

Other changes to the list included: The term ``Hantaviruses'' was

changed to ``Viruses causing hantavirus pulmonary syndrome'', ``Tick

borne encephalitis viruses'' was changed to ``Tick borne encephalitis

complex viruses''; ``Encephalitis viruses (Venezuelan, Western,

Eastern)'' was changed to ``Eastern equine encephalitis virus'' and

``Venezuelan equine encephalitis virus'', ``Ebola virus'' was changed

to ``Ebola viruses'', and ``Flexal

[[Page 55191]]

virus'' was added to the parenthetical list of ``South American

haemorrhagic fever viruses.

A large number of responses pertained to the proposed list of

select toxins. These commenters recommended additions, deletions, or

exemptions based on medical uses. Based on our review of these

comments, the following toxins or classes of toxins were deleted from

the final list: Corynebacterium diphtheriae toxin, cyanginosins,

Shigella dysenteriae neurotoxin, tetanus toxin, trichothecene

mycotoxins, and verrucologen. The following toxins were added:

aflatoxins, conotoxins, diacetoxyscirpenol, and T-2 toxin.

In the NPRM, Section 72.6(a)(6) specified that toxins be handled in

accordance with Department of Defense regulations found at 32 CFR

627.17 and in The Biological Defense Safety Program, Technical Safety

Requirements (DA Pamphlet 385-69). One commenter correctly pointed out

that the proper reference for handling toxins is 29 CFR 1910.1450,

``Occupational Exposure to Hazardous Chemicals in Laboratories.'' This

final rule is not intended to preempt, pursuant to Section 4(b)(1) of

the Occupational Safety and Health Act of 1970, any other rules

designed to protect employees from these agents.

The final rule exempts vaccine strains of viruses, and specifies

exemptions for listed agents based on coverage under other federal

regulations. Exemptions are listed in Appendix A.

We received several comments regarding some of the terminology used

in the NPRM, including pathogenicity, virulence, and less pathogenic,

One commenter preferred the term virulence to pathogenicity. CDC views

virulence and pathogenicity, which both mean the ability of an organism

to cause disease, as synonymous terms. Similarly, avirulent and

nonpathogenic are synonymous.

Several comments questioned the use of the term ``select infectious

agent'' to describe all agents subject to the rule, pointing out that

toxins are not infectious. In response to these comments, CDC has

changed ``select infectious agent'' to ``select agent'' and revised the

definition to mean ``a microorganism (virus, bacterium, fungus,

rickettsia) or toxin listed in Appendix A of this part''. The term

``select agent'' in the final rule includes only those select agents

listed in Appendix A.

One commenter wanted to know if tissue samples that only contain

small amounts of the agent or that may only be suspected of containing

a pathogen would be covered by the final rule. All materials that are

known or reasonably suspected of containing a select agent, including

tissue samples, unless exempted as a human or veterinary clinical

specimen, are subject to this regulation.

Registration of Facilities Transferring Select Agents

The NPRM proposed that commercial suppliers of select 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.

The proposed registration process required 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 agents

as described in the Third Edition of ``CDC/National Institutes of

Health (NIH) Biosafety in Microbiological and Biomedical Laboratories''

(BMBL). The NPRM also stipulated that 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.

The NPRM proposed that facilities, if approved, would be issued a

unique registration number indicating that the facility is registered

to work with these select agents at the prescribed biosafety level. The

registration number also would be used to help validate all requests

for transfer of these agents.

Incorporation of the BMBL

Some commenters questioned incorporating the BMBL into the

regulation because, in their view, the BMBL provides ``guidelines''

that are vague, and lack specificity and sufficient detail. One

commenter recommended that the BMBL be augmented or updated to provide

a clear objective standard. Because the BMBL serves as the only

nationally and internationally recognized source for biosafety

requirements for laboratories, the final rule retains the incorporation

of the BMBL. The BMBL provides the minimum requirements for BL-2, 3,

and 4 laboratories and animal facilities and is readily applicable to a

facility registration and inspection process.

Registration Process

Some commenters suggested CDC base its registration procedures on

models used by other entities. In developing the NPRM, CDC reviewed

several models, including a Nuclear Regulatory Commission (NRC)

licensing model for the use of radioactive materials; a certification

model based on National Committee for Clinical Laboratory

Standardization (NCCLS) for hospital certification programs; a model

based on the use of an Institutional Biosafety Committee similar to

that outlined in the NIH Recombinant DNA Guidelines; the United States

Department of Agriculture, Animal Plant and Health Inspection Service

(USDA/APHIS) import and transfer program for restricted animal

pathogens; the American Association for Accreditation of Laboratory

Animal Care (AAALAC) Program; and the CDC import permit program for

etiologic agents. CDC found aspects of these models adaptable or

partially adaptable to its program. CDC's program includes many

elements of these models, such as on-site inspections, registration

(user) fees, and registration and transfer requirements.

One commenter suggested providing more detail for the registration

process. Another suggested basing the registration process on a ``self-

audit'' where the registering entity would provide self-audit forms.

CDC will provide application forms to be completed by facilities

seeking registration. The application will require information

regarding laboratory practices, equipment, and other pertinent

information. Facilities will submit the completed application to CDC

for approval of registration. A facility inspection may or may not be

required prior to registration, depending on documentation supplied by

the applicant. If CDC approves the registration, a unique registration

number will be issued. Those facilities not pre-inspected will be

inspected following registration. All registered facilities will be

inspected subsequently on a periodic basis.

Appeals

As proposed in the NPRM, registrations may be denied or withdrawn,

subject to appeal. One commenter asked whether the appeals process

described in the NPRM would include a hearing. CDC interprets this to

mean an oral hearing since courts have construed the term ``hearing''

to mean the submission of written information as well as oral

testimony. Although not explicitly stated, the rule provides

flexibility for a variety of forums to ensure that appeals receive due

process. This would include an oral hearing if, in the Secretary's

discretion, such steps are necessitated by the particular facts

presented by any specific situation.

[[Page 55192]]

Transfer Requirements

The NPRM proposed that, prior to transferring one of these select

agents, both the shipping (transferor) and receiving (requestor)

parties complete required sections of the official transfer form. (EA-

101). The NPRM proposed that the EA-101 list the restricted agents and

require information about the requestor and transferor, the requesting

and transferring facilities, the registration numbers of the

transferring and receiving facilities, the name of restricted agent

requested, and the proposed use of the agent. The NPRM proposed that

the form must accompany the request or purchase order for obtaining

these restricted agents, that a copy must be maintained by both the

requesting and transferring facility, and that 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 would be a federal criminal offense. The final rule

retains all of these provisions. In addition, the final rule requires

requestors to specify on form EA-101 the number of containers and

amount per container of the agent(s) being shipped.

As discussed in the NPRM preamble, because these select agents have

the potential for causing mass destruction or widespread disease in

humans, CDC has determined intrastate transfers of these agents from

one geographic 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.

Shipping and Transfer Requirements

Several commenters were concerned about shipping select agents and

about acceptable carriers and carrier responsibilities. Nothing in this

final rule is intended to preempt other applicable Federal regulations.

Select agents included under this final rule are required to be

packaged, labeled and shipped in accordance with all applicable federal

regulations. CDC believes that compliance with existing federal

regulations on packaging, labeling, and shipping select agents, in

combination with the transfer requirements of this final rule, provide

sufficient safeguards for safe and secure transport.

Other comments expressed concern about emergency response to a

transportation incident involving a select agent. Any transportation

incident involving a select agent, including a lost or stolen package,

or a damaged package, should be reported to CDC through its 24 hours, 7

days-a-week emergency number (1-800-232-0124) by either the shipper,

recipient, or package handler. Any unexpected release of these agents

may also be covered by the National Oil and Hazardous Substances

Pollution Contingency Plan, found in 40 CFR Part 300.

Packages of select agents are required to be packaged as infectious

substances, labeled with the infectious substance and etiologic agent

label, and shipped in accord with all federal regulations. Both the DOT

infectious substance label and the CDC etiologic agent label bear CDC's

emergency phone numbers. Also, the packaging requirements for these

select agents require that the shipper's name and phone number be on

the outer package, to be used in emergencies. Thus, CDC would be able

to call the shipper to discuss matters that relate to spill clean-up.

Commenters asked for clarification regarding the relationship

between the proposed regulation and federal importation and exportation

regulations. Importers of select agents also are subject to CDC's

regulations at 42 CFR Part 71.54, ``Importation of Etiologic Agents and

Vectors,'' and are responsible for obtaining an import permit from CDC

prior to importing select agents. In such cases, CDC will require the

importer to be registered in accordance with this final rule and to

supply the registration number before the select agent is imported.

This final rule does not apply to exportation of select agents.

Exporters of select agents will continue to follow the Department of

Commerce export administration regulations at 15 CFR Parts 742, 744,

and 774, ``Commerce Control List: Microorganisms and Toxins.''

Intrafacility Transfers

Several commenters believed that the rule should cover

intrafacility transfers or at least provide guidelines for

intrafacility transfer and tracking, and that the lack of guidelines

constituted a weakness in the proposed regulation. While the NPRM

proposed that tracking of intrafacility transfers are the

responsibility of individual facilities, the final rule has been

changed to reflect that a registered facility is not required to follow

the transfer and verification requirements listed in the rule, so long

as the facility maintains adequate records of intrafacility transfers.

Thus, CDC Form EA-101 does not have to be completed when transferring a

select agent if the following conditions are met: (1) the transfer is

within a single facility at a single geographic site, (2) the intended

use of the agent remains consistent with that specified in the most

current transfer form, and (3) the facility documents the following

information for each intrafacility transfer: the name and location of

the recipient; the amount transferred, and date transferred. Recipients

are required to comply with all other parts of this final regulation,

including the requirements for storage and disposal. Questions

concerning the transfer of a select agent meeting the criteria of an

intrafacility transfer may be referred to CDC.

Single Geographic Site

Several commenters also requested clarification on the meaning of a

single geographic site. For example, does this mean a building, a

complex of buildings, or several sites within a single city? For the

purposes of this rule, CDC defines a single geographic site as the

complex of buildings and laboratories at a single mailing address. CDC

may entertain exceptions on a case-by-case basis at the time of

facility registration.

Verification Procedures

To facilitate the shipment of these select agents, the NPRM

proposed that each facility shipping or receiving a covered agent must

have a ``responsible facility official,'' and that this person be

either a biosafety officer, a senior management official of the

facility, or both. The NPRM also suggested that the responsible

facility official should not be the same person as those individuals

actually transferring and receiving the agents at the facilities.

The NPRM specified that 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 requirements for working

with the requested agent. The NPRM also required the responsible

facility official sending the restricted agent 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 could

result in immediate notification of the appropriate authorities. The

NPRM also specified timeframes for confirmation of select agent

transfer and for retention of CDC Form EA-101.

[[Page 55193]]

Responsible Facility Official

Several comments pertained to the designation of a responsible

facility official. CDC developed the concept of a responsible facility

official to ensure management oversight of the transfer process. CDC

envisioned that the responsible facility official either could be a

senior management official or a biosafety officer. However, commenters

indicated that there are circumstances when a biosafety officer may be

inappropriate, such as for facilities that use toxins. As a result of

the comments we received, CDC has revised the definition of a

Responsible Facility Official to include a senior management official

or a ``safety officer,'' the term ``safety'' being substituted for

``biosafety''. Although not required in the final rule, a safety

officer responsible for select microbial agents or recombinant

microorganisms should have a background in microbiology and training

and experience in biosafety; a safety officer responsible for select

toxins should have a background in chemistry and training and

experience in chemical safety.

Another commenter suggested that a biosafety officer should be a

Registered Biosafety Professional (RBP). CDC supports the concept of

certification of safety professionals in their area of specialty, but

has not determined that a specific certification should be required by

this final rule.

Several commenters were concerned about the liability of safety

officers. CDC believes that these matters rest with facility

management, and are beyond the scope of this final rule.

One commenter requested clarification on the meaning of

``officially affiliated'' as used in section 72.6(e)(1)(ii),

Verification Procedures. Personnel may be affiliated with a facility in

a variety of ways, such as employee, contractor, consultant, graduate

student, postdoctoral fellow, visiting scientist or staff member. Of

these affiliations, we believe that ``employee'' is the affiliation

most directly related to the facility. CDC therefore has replaced

``officially affiliated'' with ``employee'' in the final rule.

Timeframe for Transfer Confirmation and EA-101 Retention

A number of commenters thought that the time periods for the

requestor acknowledging receipt of the agent to the transferor either

electronically or by paper copy were too short. CDC has extended the 24

hour time period for telephonic or electronic notification to 36 hours,

but feels that 3 business days is adequate for a paper copy receipt.

CDC will accept a facsimile (FAX) transmission receipt as the

equivalent of a paper copy receipt. CDC also will accept a facsimile

transmission from the transferror of a completed EA-101.

In addition, the time required for retaining a copy of CDC Form EA-

101 after agent consumption of destruction has been extended from 1

year to 5 years in the ``Request for Agents'' section in the final

rule. This time period is consistent with the retention requirement in

the ``Disposal of Agents'' section of the final rule, and is based on

the five-year statute of limitations for bringing criminal prosecution

under Title 18, United States Code, Section 1001, and under Title 42,

United States Code, Section 271.

Agent Disposal Requirements

The NPRM proposed that select agents be stored in accordance with

prudent laboratory practices, and stipulated that facilities must have

in place procedures for the appropriate disposal of agents.

Several commenters requested more details on suitable location for

the storage of agents and the type of security required. Because

laboratory structures vary considerably, only broad guidance can be

provided beyond what is specified in the final rule. Prudent laboratory

practices suggest storing select agents such that unauthorized and

unqualified persons cannot gain access to them and such that the

responsible person can account for quantities stored. Prudent practice

also suggests that storage be secure, including controlled access to

the storage area and storage equipment.

Several commenters suggested that the regulation include specific

directions on disposal of selected agents. The final rule specifies

that disposal of select agents must be at the facility, by known

effective methods, and the facility should maintain records as to the

quantity destroyed, date of destruction, and method of destruction and

persons responsible for destruction. The registering entity must be

notified of the disposal or complete consumption of a select agent by

completing this section on EA-101. If registration is withdrawn, select

agents must be disposed of as required in the regulation. In addition

to these rule requirements, it is advisable to retain use and

consumption records to account for supplies of toxins, and to maintain

records pertaining to storage, consumption and disposal of agents.

Other commenters questioned the need to destroy select agents on-

site, pointing out that many microbiology laboratories do not have

decontamination autoclaves and they transport their used cultures and

stocks off-site for autoclaving or incineration. Similarly, many

laboratories using toxins transport them off site for incineration or

other means of destruction. The BMBL specifies that infectious agents

removed from BL-3 and BL-4 laboratories be decontaminated on-site,

preferably by autoclaving. Toxins can be treated with strong oxidizing

agents to inactivate them before removal from laboratories. Thus, the

final rule retains the requirement to destroy select agents on-site.

Once inactivated, the special agents can be sent to off-site locations

for incineration or other ultimate disposal.

Other commenters inquired about how the regulatory authority would

know when all of an agent previously transferred to a facility was

destroyed. It should be noted that this regulation only applies to

transfers of agents after the effective date of this final rule. To

ensure compliance with this regulation, CDC combined facility

management oversight of select agents with facility employee

responsibilities and stiff penalties for intentional or willful

violations. CDC believes that facility integrity and personal

responsibilities combined with these penalties will prove effective in

ensuring the controlled safe use, storage, and disposal of select

agents.

One commenter expressed concern that the NPRM did not make specific

reference to retention requirements for agents which are stored in a

culture repository. If a select agent is in a laboratory or

institutional culture repository prior to the effective date of this

final rule, the regulation requires no action until the select agent is

transferred. When the agent is transferred, all requirements of this

regulation apply to the transaction.

Research and Clinical Exemptions

In order to provide strains for reference, diagnostic, and research

studies at Biosafety Level 2 facilities, the NPRM proposed that less

pathogenic strains, such as vaccine strains of restricted viral agents

as described in the BMBL or those specifically mentioned on the CDC

Form EA-101, be exempt from the list of select agents. The NPRM also

proposed to exempt toxins for medical use, inactivated for use as

vaccines, or preparations for biomedical research use at an LD50

for vertebrates of more than 100 nanograms per kilogram of body weight,

and to exempt transfer of clinical specimens for diagnostic and

verification purposes. However, the NPRM proposed to require

[[Page 55194]]

that 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

could not be transferred to another site without using the transfer

form and approval by the responsible facility officials.

Several commenters recommended that clinical specimens should be

subject to the regulation, and expressed the view that exempting

clinical specimens provided a ``loophole''. It should be noted that

regulation requires that clinical specimens, in order to be exempt,

must be intended for diagnostic, reference and/or verification

purposes. Other uses of a clinical specimen containing a select agent,

or a select agent isolated from a clinical specimen, such as for

research purposes, will subject the clinical laboratory to this

regulation.

Another commenter requested clarification as to when an agent from

a clinical specimen becomes subject to the regulation. Subsequent to

the isolation and identification of a select agent from a clinical

specimen, it must be transferred to a registered facility or destroyed.

Other commenters questioned how clinical labs might receive select

agents for proficiency testing or order reference strains. The rule

specifically exempts clinical laboratories certified under the Clinical

Laboratory Improvement Amendments of 1988, (42 U.S.C. 263a) (CLIA),

that utilize these select agents for diagnostic, reference,

verification, or proficiency testing purposes. In addition, the rule

provides procedures for facilities that are not CLIA laboratories but

are transferring or receiving select agents to or from a CLIA

laboratory. No additional paperwork on behalf of CLIA laboratories is

required by this final rule. CDC will accept a CLIA certification

number on CDC Form EA-101 in lieu of the required institutional

registration number, as stipulated in this final rule.

Another commenter requested clarification of the term ``less

pathogenic'' as a criterion for exemption. CDC has determined that it

is premature to issue blanket exemptions of attenuated, avirulent, or

less pathogenic strains of agents on the restricted list at this time.

Attenuated strains of select agents approved for human vaccination

purposes by FDA or other recognized national or international

organizations will be exempt. All other attenuated, avirulent, or less

pathogenic strains will not be exempt at this time. Additional

exemptions for otherwise covered strains will be considered when CDC

reviews and updates the list of select agents (Appendix A). Individuals

seeking additions to the list of exemptions should submit a request to

CDC that specifies the agent or strain to be exempted and explains why

such an exemption should be granted. Future changes to the list of

exemptions will be published in the Federal Register for review and

comment prior to inclusion on Appendix A.

Criminal Penalties

Violations of the final rule are subject to federal criminal

penalties. A false, fictitious, or fraudulent statement or

representation on the forms required in the regulation for registration

of facilities or for transfers of select agents is a violation of Title

18, United States Code, Section 1001. An individual offender is subject

to imprisonment for not more than five years, a fine as provided in

Section 3571(b) of Title 18, or both. An organization that violates

Section 1001 is subject to a fine as provided in Section 3571(c) of

Title 18. Other violations of the final rule are subject to criminal

penalties as prescribed in Title 42, United States Code, Section 271. A

violation of Section 271 subjects an individual offender to

imprisonment for not more than one year, a fine as provided in Section

3571(b) of Title 18, or both. An organization that violates Section 271

is subject to a fine as provided in Section 3571(c) of Title 18.

Enforcement

At least one comment questioned who would constitute ``appropriate

law enforcement authorities.'' While the rule is purposely nonspecific

on this point to allow flexibility, depending upon individual

circumstances, it is anticipated that federal law enforcement

authorities, specifically the Federal Bureau of Investigation, and

other federal agencies may require access to the records and database

for law enforcement purposes. Assistance from state and local

authorities may be required on an as-needed basis to aid federal

agencies, as dictated by individual situations and as determined

necessary by the Secretary and/or the Attorney General.

On the issue of law enforcement, numerous comments were received

concerned with the criminal penalties an offender may be subject to for

violations of the rule. Most of these comments were concerned that

inadvertent or unintentional mistakes could result in criminal

punishment. Other commenters suggested adding language to the criminal

penalties notices to describe the mental state required for violation

of the rule. There are two principal criminal statutes implicated in

violations of the rule. Title 18, United States Code, Section 1001

applies to false statements made to the Federal Government in

connection with the rule. Such false statements may be made in

connection with a facility's application to become a registered entity,

completion of CDC Form EA-101 for transfers of select agents, and in

other circumstances. To constitute a criminal violation, Section 1001

requires that the false statement be made ``knowingly and willfully.''

Other violations of the rule are covered under Title 42, United States

Code, Section 271. This violation is classified as a misdemeanor and

requires a ``knowing'' mental state by the defendant. Thus, both of

these criminal statutes subject offenders to punishment for knowing

conduct.

Possession

Several commenters questioned whether the rule was intended to

govern possession as well as transfer of the select agents listed in

the rule. This final rule and associated criminal penalties apply only

to interstate and intrastate transfer of these agents. Possession of

these agents is outside the scope of this final rule; however, and

individual in possession of a ``biological agent or toxin * * * for use

as a weapon'' as defined in Title 18 of the U.S. Code, may be subject

to separate criminal penalties (18 U.S.C. 175 et seq.).

Publicly Available Information

Several comments were received regarding the information

collections required in Sec. 72.6(c)(2) (i) and (ii). Specifically,

commenters were concerned with the public availability of the database

of registered facilities and repository of transfer forms. While one

commenter thought public availability would prove useful to those

facilities transferring agents by creating an informal checklist of

other registered facilities, the majority of comments suggested that

neither the database nor the registry of transfer forms should be

available to the public. Of chief concern was fear that a publicly

available list of registered facilities would serve as a ``roadmap'' to

would-be terrorist of facilities possessing these dangerous agents.

Another concern was that the database and transfer forms may contain

proprietary information.

Taking into consideration these comments, CDC has determined that

making this information available through a public database could

compromise one of the primary

[[Page 55195]]

purposes of the proposed rule and its authorizing legislation, i.e.,

limiting unauthorized access to these select agents. Therefore, CDC

will not create publicly available databases of the information

referenced in Sec. 72.6(c)(2) (i) or (ii).

In addition to comments concerned with the public availability of

information gathered pursuant to this rule, some commenters suggested

adding language to the rule explaining that trade secret and/or

confidential commercial or financial information would be exempt from

disclosure under the Freedom on Information Act (FOIA).

Currently, CDC exempts from public release trade secret and/or

confidential commercial or financial information in accordance with the

Freedom on Information Act (5 U.S.C. 552), Executive Order 12600, and

Department of Health and Human Services regulations found at 42 CFR

Part 5. In accordance with these authorities, CDC provides a submitter

with notice of receiving a third-party request for information whenever

the requested records have been designated by the submitter as

confidential commercial information or the agency has reason to believe

that disclosure of the information could reasonably be expected to

cause substantial competitive harm. The submitter is given a reasonable

period of time in which the submitter may object to the FOIA disclosure

of any specified portion of the information and to state all grounds

upon which disclosure is opposed. CDC gives careful consideration to

all such specified grounds for nondisclosure prior to making an

administrative determination of the issue. In all instances when the

agency determines to disclose the requested records, CDC provides the

submitter a written statement briefly explaining why the submitter's

objections are not sustained. Such a statement shall, to the extent

permitted by law, be provided a reasonable number of days prior to a

specified disclosure date. If CDC decides to release the information,

the submitter may pursue legal action to prevent such release.

Because these existing authorities already explain the policies and

procedures utilized by CDC in releasing and/or withholding trade secret

and/or confidential commercial or financial information, further

explanation is not being included in this final rule.

Proprietary concerns were also raised regarding the provision of

transfer forms to state health departments. Some commenters suggested

that states generally may benefit by receiving these transfer forms

because they could independently track agents arriving and leaving the

state.

However, disclosure of EA-101 forms may compromise proprietary

interest of the concerned facilities. Additionally, providing a copy of

each EA-101 form to the appropriate state health department would

constitute an administrative burden on the agency. Further, the

Secretary may provide the forms to state law enforcement authorities

under appropriate circumstances. For these reasons, CDC has determined

that it will not provide state health departments with the transfer

forms on a routine basis. Nor is it contemplated that parties to the

transfer of select agents will provide a copy of the form to state

health departments.

Restrictions for Genetic Elements

The transfer of genetic elements into other cells or organisms

offers tremendous possibilities for improving the public health.

However the transfer of genetic elements coding for virulence genes,

antibiotic resistance, or toxins offers the potential for creating new

and deadly pathogens. A large number of comments were received asking

for further clarifications of the restrictions placed on genetically

modified microorganisms or genetic elements. Commenters stated that

``sequences associated with pathogenicity were vague'' and questioned

what constituted the toxic subunit(s) of a restricted toxin. CDC

considers as a select agent, under the definition, and subject to the

final rule, genetic elements from a select agent, that contain a

nucleic acid sequence(s) which, if inserted into an appropriate host

system, are reasonably believed capable of producing disease or

toxicosis. Genetic elements from a select agent that contains a nucleic

acid sequence(s) which, if inserted into an appropriate host system, do

not cause disease or toxicosis are not subject to the final rule.

Summary of Changes

1. The title of the regulation was changed from, ``Additional

Requirements for Facilities Transferring or Receiving Select Infectious

Agents,'' to ``Additional Requirements for Facilities Transferring or

Receiving Select Agents,'' deleting the word, ``Infectious.'' The word,

``infectious'' was deleted in all instances in the rule and ``select

agent'' is now defined in Sec. 72.6(j) as, ``a microorganizatism,

(virus, bacterium, fungus, rickettsia) or toxin listed in Appendix A of

this part.'' The subsequent language dealing with recombinant

organisms/molecules was revised and now reads: ``The term also includes

(1) genetically modified microorganisms or genetic elements from

organisms on Appendix A, shown to produce or encode for a factor with a

disease, and (2) genetically modified microorganisms or genetic

elements that contain nucleic acid sequences coding for any of the

toxins on Appendix A, or their toxic subunits.''

2. In Sec. 72.6(a)(1) the word, ``laboratory'' was deleted.

Consistently throughout the final rule, the term ``facility'' is used

to describe regulated entities.

3. The word ``minimum'' was added to Sec. 72.6(a)(5).

4. In Sec. 72.6(a)(6), the reference to ``32 CFR 627.17 and in The

Biological Defense Safety Program, Technical Safety Requirements (DA

Pamphlet 385-69), Subpart C--Operational Requirements'' was replaced

with, ``29 CFR 1910.1450, `Occupational Exposure to Hazardous Chemicals

in Laboratories'.''

5. The last sentence of Sec. 72.6(c)(2)(i) regarding the public

availability of the databases maintained by registering entities has

been deleted.

6. In Sec. 72.6(d)(1), a new section (viii) was added. Section

(viii) adds a new provision to CDC Form EA-101 that requires that the

quantity of agent being shipped (number of containers and amount per

container) be specified on EA-101.

7. In Sec. 72.6(d)(2), the time required for retaining a copy of

CDC Form EA-101 after agent consumption or destruction has been

extended from 1 year to 5 years to make this section consistent with

section 72.6(i)(2). The last two sentences of Sec. 72.6(d)(2) were

broken into separate sections, 72.6(d)(3) and 72.6(d)(4).

8. In Sec. 72.6(e)(1)(ii), the term, ``employee'' was substituted

for ``officially affiliated.''

9. In Section 72.6(e)(2), ``and the appropriate law enforcement

authorities'' was deleted.

10. Grammatical changes were made to Sec. 72.6(f)(1) to make the

section clearer.

11. Twelve (12) hours were added to the time period that the

requesting facility's responsible official is allowed to acknowledge

receipt of an agent, as required in Sec. 72.6(f)(2). Additional

language was also added to Sec. 72.6(f) (2) and (3) to clearly indicate

that a facsimile transmission, in addition to a paper copy, is a

sufficient means of transmitting CDC Form EA-101.

12. The reference to the BMBL in Sec. 72.6(h)(1) was deleted as

redundant. Specific language was added to this section to clearly

indicate that strains

[[Page 55196]]

exempted from this regulation are found in Appendix A and CDC Form EA-

101.

13. Technical language changes were made in Sec. 72.6(d)(2) and

72.6(i)(2) to accurately describe that the same procedures required

when an agent is destroyed also apply once a toxin is consumed. Also,

the formal notice of consumption of a toxin or destruction of an agent

required by section 72.6(i)(2) must now be specifically noted on the

CDC Form EA-101.

14. Several changes were made to 72.6(h) dealing with exemptions.

A. Section 72.6(h)(1) was deleted. The section previously numbered

72.6(h)(2) has been renumbered 72.6(h)(1)(i). Technical changes were

also made to make the section clearer and more accurate. This section

now reads, ``The agent is part of a clinical specimen intended for

diagnostic, reference, or verification purposes. Isolates of covered

agents from clinical specimens shall be disposed of in accordance with

paragraph (i) of this part after diagnostic, reference, or verification

procedures have been completed.''

B. The section previously numbered 72.6(h)(3) has been renumbered

72.6(h)(1)(ii).

C. A new Sec. 72.6(h)(1)(iii) clearly indicates that exempted

strains are specified in Appendix A. This section now also describes a

procedure for applying for an exemption to this rule.

D. A new Sec. 72.6(h)(2) was added that exempts from the rule

clinical laboratories that are certified under the Clinical Laboratory

Improvement Amendments of 1988 (42 U.S.C. 263a) (CLIA) that transfer

and receive select agents for diagnostic, reference, verification, or

proficiency testing purposes.

E. Facilities that are not CLIA laboratories but are transferring

or receiving select agents to or from a CLIA laboratory must comply

with the provisions of 72.6(h)(3). No additional paperwork is required

of CLIA laboratories by this regulation.

15. The definition of ``transfer'' in Sec. 72.6(j) was expanded to

clearly indicate that intrafacility transfers of select agents are not

subject to Sec. 72.6(d), (e), and (f) so long as (1) the original

conditions required in the NPRM are met, and (2) the name and location

of the recipient, and the date and amount of agent transferred, are

adequately maintained in the registered facility's records.

ANALYSIS OF IMPACTS

Review Under Executive Order 12866, Sections 202 and 205 of the

Unfunded Mandate Reform Act of 1995 (Pub. L. 104-4), and by the

Regulatory Flexibility Act (5 U.S.C. 603-605).

The Department has examined the potential impact of this 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).

Regulatory Impact Analysis

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 rule is designed to ensure that select 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 Unfunded Mandates Reform Act of 1995, in sections 202 and 205,

requires that agencies prepare several analytic statements for a rule

that may result in annual expenditures by State, local and tribal

governments, or by the private sector, of $100 million. Because this

final rule 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 permits agency heads to certify that a

rule will not, if promulgated, have a significant economic impact on a

substantial number of small entities. The Secretary hereby has

determined that this rule would not have such impact, as it would

primarily affect large research institutions.

Review under the Paperwork Reduction Act of 1995

The final rule contains information collection requirements that

have been approved by the Office of Management and Budget (OMB) under

the Paperwork Reduction Act of 1995 and assigned control Number 0920-

0199. (Persons are not required to respond to a collection of

information unless a currently valid OMB control number is evident.)

The title, description and respondent description of the information

collection are shown below with an estimate of the annual reporting

burden. The estimate includes the time for reviewing instructions,

gathering and maintaining the data needed, and completing and reviewing

the collection of information.

Title: Additional Requirements for Facilities Transferring or

Receiving Select Agents.

Description: The Antiterrorism and Effective Death Penalty Act of

1996 (Pub. L. 104-132) authorizes the Secretary of Health and Human

Services (HHS) to regulate the transfer of certain agents harmful to

humans. The Centers for Disease Control and Prevention (CDC) is the

agency within the Department responsible for promulgating this

regulation. This rule is designed to ensure that select 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 facilities such as those operated by government

agencies, universities, research institutions, and commercial entities.

Those facilities requesting select 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 agents in accordance with requirements of this regulation.

Once registered, facilities must complete a federally-developed

form, CDC EA-101, for each transfer of an agent covered by this 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 reqesting facility's registration number,

the transferring facility's registration number, the name of the

agent(s) being shipped, the quantities of the agent(s) being

transferred (number of containers being transferred and amount per

container), and the proposed use of the agent. As a result of the

information collection requirements of this regulation, CDC expects

that respondents will incur only minimal routine administrative costs,

such as those associated with telephone calls, mailing, and facsimile

transmission. CDC does not expect that respondents will incur any

capital costs, or even significantly increased operating costs.

Description of Respondents: Commercial suppliers of these select

[[Page 55197]]

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

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

Frequency Total

CFR section Number of of annual Hours per Total hours

respondents responses responses response

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

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: The above citations are currently cleared

under 30 CFR Part 11 as OMB control Number 0920-0199.

List of Subjects in 42 CFR Part 72

Biologic, Incorporation by reference, Packaging and containers,

Transportation.

Dated: August 23, 1996.

David Satcher,

Director, Centers for Disease Control and Prevention.

Dated: September 17, 1996.

Donna E. Shalala,

Secretary, Department of Health and Human Services.

For the reasons set out in the preamble, 42 CFR Chapter I is

amended as set forth below.

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; 42 U.S.C. 262 note.

2. Sections 72.6 and 72.7 and Appendix A are added to read as

follows:

Sec. 72.6 Additional requirements for facilities transferring or

receiving select agents.

(a) Registration of facilities.

(1) Prior to transferring or receiving a select agent listed in

Appendix A of this part, a facility shall register with a registering

entity authorized by the Secretary (paragraph (c) of this section) or

be approved by the Secretary as equipped and capable of handling the

covered agent at Biosafety Level (BL) 2, 3, or 4, depending on the

agent.

(2) Registration will include:

(i) Sufficient information provided by the responsible facility

official indicating that the applicant facility, and its laboratory or

laboratories, are equipped and capable of handling the agents at BL 2,

3, or 4, depending upon the agent, and the type of work being performed

with the agents;

(ii) Inspection of the applicant facility at the discretion of the

Secretary or the registering entity in consultation with the Secretary;

(iii) Issuance by the registering entity of a registration number

unique to each facility;

(iv) Collection of a periodic site registration fee by the

registering entity or the Secretary.

A schedule of fees collected by the Secretary to cover the direct

costs (e.g., salaries, equipment, travel) and indirect costs (e.g.,

rent, telephone service and a proportionate share of management and

administration costs) related to administration of this part will be

published in the Federal Register and updated annually.

(v) Follow-up inspections of the facility by the registering entity

or the Secretary, as appropriate, to ensure the facility continues to

meet approved standards and recordkeeping requirements.

(3) Such registration shall remain effective until relinquished by

the facility or withdrawn by the Secretary or the registering entity.

(4) The registration may be denied or withdrawn by the registering

entity or the Secretary based on:

(i) Evidence that the facility is not or is no longer capable of

handling covered agents at the applicable biosafety level;

(ii) Evidence that the facility has handled covered agents in a

manner in contravention of the applicable biosafety level requirements;

(iii) Evidence that the facility has or intends to use covered

agents in a manner harmful to the health of humans;

(iv) Evidence that the facility has failed to comply with any

provisions of this part or has acted in a manner in contravention of

this part; or

(v) Failure to pay any required registration fee.

(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. The Director of the Federal

Register has approved under 5 U.S.C. 552(a) and 1 C.F.R. Part 51 the

incorporation by reference of the above publication. Copies may be

obtained from the Superintendent of Documents, U.S. Government Printing

Office, Washington D.C. 20402. Copies may be inspected at the Centers

for Disease Control and Prevention, 1600 Clifton Road, Atlanta,

Georgia, or at the Office of the Federal Register, 800 North Capitol

Street N.W., Suite 700, Washington D.C.

(6) Additional specific requirements for handling toxins subject to

this part must be met and are found in 29 CFR Sec. 1910.1450,

``Occupational Exposure to Hazardous Chemicals in Laboratories.''

(b) Appeals.

A decision made by the Secretary or a registering entity to deny or

withdraw registration of a particular facility may be appealed to the

Secretary. An application for appeal must be received by the Secretary

no later than 14 days after the appealing party's application for

registration was denied or no later than 14 days after the appealing

party's registration was withdrawn. The application must clearly

identify the issues presented by the appeal and fully explain the

appealing party's position with respect to those issues. The Secretary

may allow the filing of opposing briefs, informal conferences, or

whatever steps the Secretary considers appropriate to fairly resolve

the appeal.

(c) Authorized registering entities.

(1) The Secretary may authorize a state agency or private entity to

register facilities under paragraph (a) of this section, if the

Secretary determines that the registering entity's criteria for

[[Page 55198]]

determining the biosafety standards for facilities handling select

agents are consistent with the requirements contained in the CDC/NIH

publication ``Biosafety in Microbiological and Biomedical

Laboratories,'' Third Edition.

(2) A registering entity shall maintain:

(i) A database of all facilities formerly and currently registered

as BL 2, 3, or 4 and capable of working with agents in Appendix A of

this part. The database shall include the name and address of the

registered facility, the date the facility was registered, the

facility's registration number, and the name and phone number of the

responsible facility official.

(ii) A copy of each CDC Form EA-101 transmitted by each transferor

registered by that registering entity. Such forms shall be made readily

accessible to the Secretary and to appropriate federal law enforcement

authorities and/or authorized local law enforcement authorities.

(3) In the event the Secretary authorizes more than one registering

entity, or if otherwise necessary, the Secretary may require the

establishment of a consolidated database to carry out the provisions of

Sec. 72.6(c)(2).

(d) Requests for agents.

(1) Prior to the transfer of any agent contained in Appendix A of

this part, a CDC Form EA-101 must be completed for each transfer

sought. As specified in CDC Form EA-101, the information provided must

include:

(i) The name of the requestor and requesting facility;

(ii) The name of the transferor and transferring facility;

(iii) The names of the responsible facility officials for both the

transferor and requestor;

(iv) The requesting facility's registration number;

(v) The transferring facility's registration number;

(vi) The name of the agent(s) being shipped;

(vii) The proposed use of the agent(s); and

(viii) The quantity (number of containers and amount per container)

of the agent(s) being shipped.

(2) The form must be signed by the transferor and requestor, and

the responsible facility officials representing both the transferring

and requesting facilities.

(3) A copy of the completed CDC Form EA-101 must be retained by

both transferring and requesting facilities for a period of five (5)

years after the date of shipment or for five (5) years after the agents

are consumed or properly disposed, whichever is longer.

(4) All CDC forms EA-101 must be produced upon request to

appropriate federal and authorized local law enforcement authorities,

officials authorized by the Secretary, and officials of the registering

entity.

(e) Verification of registration.

(1) Prior to transferring any agent covered by this part, the

transferor's responsible facility official must verify with the

requestor's responsible facility official, and as appropriate, with the

registering entity:

(i) That the requesting facility retains a valid, current

registration;

(ii) That the requestor is an employee of the requesting facility;

and

(iii) That the proposed use of the agent by the requestor is

correctly indicated on CDC Form EA-101.

(2) In the event that any party is unable to verify the information

required in paragraph (e)(1) of this section, or there is suspicion

that the agent may not be used for the requested purpose, then the

party shall immediately notify CDC.

(f) Transfer.

(1) Upon completion of the CDC Form EA-101 and verification of

registration, the transferring facility must comply with the packaging

and shipping requirements in this part or other applicable regulations

when transferring the agent.

(2) The requesting facility's responsible official must acknowledge

receipt of the agent telephonically or otherwise electronically within

36 hours of receipt and provide a paper copy or facsimile transmission

of receipt to the transferor within 3 business days of receipt of the

agent.

(3) Upon telephonic acknowledgment of receipt of the agent, the

transferor shall provide a completed paper copy or facsimile

transmission of CDC Form EA-101 within 24 hours to the registering

entity (holding that facility's registration), in accordance with

Sec. 72.6(c)(2) for filing in a centralized repository.

(g) Inspections.

(1) Registering entities or the Secretary may conduct random or for

cause inspections of registered facilities to assure compliance with

this part. All CDC forms EA-101 and records deemed relevant by

inspecting officials must be produced upon request to authorized

personnel conducting these inspections. Inspections may also include

review of the mechanisms developed by a facility to track intrafacility

transfers as well as the facility's agent disposal procedures.

(2) In addition, the Secretary may conduct inspections of

registering entities, and/or any consolidated database established in

accordance with Sec. 72.6(c)(3), to assure compliance with this part.

(h) Exemptions.

(1) Exemptions for certain select agents: Select agents otherwise

covered by this part are exempt from its provisions if:

(i) The agent is part of a clinical specimen intended for

diagnostic, reference, or verification purposes. Isolates of covered

agents from clinical specimens shall be disposed of in accordance with

Sec. 72.6(i) after diagnostic, reference, or verification procedures

have been completed;

(ii) The agent is a toxin having an LD50 for vertebrates of

more than 100 nanograms per kilogram of body weight which is used for

legitimate medical purposes or biomedical research or is one of the

listed toxins which has been inactivated for use as a vaccine or

otherwise detoxified for use in biomedical research procedures; or

(iii) The agent(s) is an exempted strain specified in Appendix A of

this part and/or CDC Form EA-101. Additional exemptions for otherwise

covered strains will be considered when CDC reviews and updates the

list of select agents (Appendix A of this part). Individuals seeking

additions to the list of exemptions should submit a request to CDC that

specifies the agent or strain to be exempted and explains why such an

exemption should be granted. Future changes to the list of exemptions

will be published in the Federal Register for review and comment prior

to inclusion on Appendix A of this part.

(2) Exemption of CLIA certified laboratories: Clinical laboratories

certified under the Clinical Laboratory Improvement Amendments of 1988,

(42 U.S.C. 263a) (CLIA), that utilize these select agents for

diagnostic, reference, verification, or proficiency testing purposes

are exempt from the provisions of Sec. 72.6.

(3) Procedures for facilities that are not CLIA laboratories but

are transferring or receiving select agents to or from a CLIA

laboratory: Facilities that are not CLIA laboratories but are

transferring or receiving select agents to or from a CLIA laboratory

must comply with the following provisions. (No additional paperwork on

behalf of CLIA laboratories is required by this section.)

(i) Prior to transferring a select agent subject to this part to a

CLIA laboratory for diagnostic, reference, verification, or proficiency

testing purposes, the transferor must:

(A) Provide the following information on CDC Form EA-101:

(1) The name of the requestor and requesting facility;

[[Page 55199]]

(2) The name of the transferor and transferring facility;

(3) The name of the transferor's responsible facility official;

(4) The requesting facility's CLIA certification number (which the

transferor must verify as valid and current with the registering

entity);

(5) The transferring facility's registration number;

(6) The name of the agent(s) being shipped;

(7) The proposed use of the agent(s); and

(8) The quantity (number of containers and amount per container) of

the agent(s) being shipped.

(B) Verify receipt of the agent with the CLIA laboratory and note

such receipt on CDC Form EA-101;

(C) Transmit a copy of the form, signed by the transferror and the

responsible facility official representing the transfering facility, to

the registering entity holding the transferring facility's

registration; and

(D) Retain a copy of CDC Form EA-101 in accordance with

Sec. 72.6(d)(3) and Sec. 72.6(d)(4).

(ii) Prior to receiving a select agent listed in Appendix A of this

part from a CLIA laboratory, the requestor must be registered in

accordance with Sec. 72.6(a) and comply with the following

requirements:

(A) Provide the following information on the CDC Form EA-101:

(1) The name of the requestor and requesting facility;

(2) The name of the transferor and transferring facility;

(3) The name of the requestor's responsible facility official;

(4) The transferring facility's CLIA certification number;

(5) The requesting facility's registration number;

(6) The name of the agent(s) being shipped;

(7) The proposed use of the agent(s); and

(8) The quantity (number of containers and amount per container) of

the agent(s) being shipped.

(B) Upon receiving the agent, note such receipt on CDC Form EA-101;

(C) Transmit a copy of CDC Form EA-101, signed by the requestor and

the responsible facility official representing the requesting facility,

to the registering entity holding the requesting facility's

registration;

(D) Retain a copy of the CDC Form EA-101 in accordance with

Secs. 72.6(d)(3) and 72.6(d)(4);

(E) Comply with the disposal requirements of Sec. 72.6(i) and all

other sections of this part when subsequently transferring the agent.

(i) Agent disposal.

(1) Upon termination of the use of the agent, all cultures and

stocks of it will be

(i) Securely stored in accordance with prudent laboratory

practices,

(ii) Transferred to another registered facility in accordance with

this part, or

(iii) Destroyed on-site by autoclaving, incineration, or another

recognized sterilization or neutralization process.

(2) When an agent, previously transferred to a facility in

accordance with this part, is consumed or destroyed, the responsible

facility official must formally notify the registering entity. Formal

notification must be noted on CDC Form EA-101 and a copy kept on record

by the responsible facility official for a period of five (5) years and

is subject to paragraph (g) of this section.

(j) Definitions. As used in this section:

Facility means any individual or government agency, university,

corporation, company, partnership, society, association, firm, or other

legal entity located at a single geographic site that may transfer or

receive through any means a select agent subject to this part.

Registering entity means an organization or state agency authorized

by the Secretary to register facilities as capable of handling select

agents at Biosafety Level 2, 3, or 4, depending on the agent, in

accordance with the CDC/NIH publication ``Biosafety in Microbiological

and Biomedical Laboratories.''

Requestor means any person who receives or seeks to receive through

any means a select agent subject to this part from any other person.

Responsible facility official means an official authorized to

transfer and receive select agents covered by this part on behalf of

the transferor's and/or requestor's facility. This person should be

either a safety officer, a senior management official of the facility,

or both. The responsible facility official should not be an individual

who actually transfers or receives an agent at the facility.

Secretary means the Secretary of the Department of Health and Human

Services or her or his designee.

Select agent means a microorganism (virus, bacterium, fungus,

rickettsia) or toxin listed in Appendix A of this part. The term also

includes:

(1) Genetically modified microorganisms or genetic elements from

organisms on Appendix A of this part, shown to produce or encode for a

factor associated with a disease, and

(2) Genetically modified microorganisms or genetic elements that

contain nucleic acid sequences coding for any of the toxins on Appendix

A of this part, or their toxic submits.

Single geographic site means a building or complex of buildings at

a single mailing address.

Transfer means:

(1) The conveyance or movement from a point or origination to a

point of destination either:

(i) From one state or territory to another or;

(ii) Entirely within one contiguous state or territory.

(2) Intrafacility transfers within a registered facility located at

a single geographic site are not covered by the provisions of Sec. 72.6

(d), (e), and (f) provided that:

(i) The intended use of the agent remains consistent with that

specified in the most current transfer form; and

(ii) For each intrafacility transfer, the facility maintains

records that include the name and location of the recipient; the amount

of agent transferred, and the date transferred. Such records must be

maintained for a period of five (5) years after the date of transfer or

for five (5) years after the agents are consumed or properly disposed,

whichever is longer.

Transferor means any person who transfers or seeks to transfer

through any means a select agent subject to this part to any other

person.

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 or 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 Agents

Viruses

1. Crimean-Congo haemorrhagic fever virus

2. Eastern Equine Encephalitis virus

3. Ebola viruses

4. Equine Morbillivirus

5. Lassa fever virus

6. Marburg virus

7. Rift Valley fever virus

8. South American Haemorrhagic fever viruses (Junin, Machupo,

Sabia, Flexal, Guanarito)

9. Tick-borne encephalitis complex viruses

10. Variola major virus (Smallpox virus)

11. Venezuelan Equine Encephalitis virus

12. Viruses causing hantavirus pulmonary syndrome

13. Yellow fever virus

Exemptions: Vaccine strains of viral agents (Junin Virus strain

candid #1, Rift Valley

[[Page 55200]]

fever virus strain MP-12, Venezuelan Equine encephalitis virus

strain TC-83, Yellow fever virus strain 17-D) are exempt.

Bacteria

1. Bacillus anthracis

2. Brucella abortus, B. melitensis, B. suis

3. Burkholderia (Pseudomonas) mallei

4. Burkholderia (Pseudomonas) pseudomallei

5. Clostridium botulinum

6. Francisella tularensis

7. Yersinia pestis

Exemptions: vaccine strains as described in Title 9 CFR, 78.1

are exempt.

Rickettsiae

1. Coxiella burnetii

2. Rickettsia prowazekii

3. Rickettsia rickettsii

Fungi

1. Coccidioides immitis

Toxins

1. Abrin

2. Aflatoxins

3. Botulinum toxins

4. Clostridium perfringens epsilon toxin

5. Conotoxins

6. Diacetoxyscirpenol

7. Ricin

8. Saxitoxin

9. Shigatoxin

10. Staphylococcal enterotoxins

11. Tetrodotoxin

12. T-2 toxin

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 are exempt. National standard toxins required for

biologic potency testing as described in 9 CFR Part 113 are exempt.

Recombinant Organisms/Molecules

1. Genetically modified microorganisms or genetic elements from

organisms on Appendix A, shown to produce or encode for a factor

associated with a disease.

2. Genetically modified microorganisms or genetic elements that

contain nucleic acid sequences coding for any of the toxins listed in

this Appendix, or their toxic subunits.

Other Restrictions

The deliberate transfer of a drug resistance trait to

microorganisms listed in this Appendix that are not known to acquire

the trait naturally is prohibited by NIH ``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.

Additional Exemptions

1. Products subject to regulation under the Federal Insecticide

Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.) and the Toxic

Substances Control Act (15 U.S.C. 2601 et seq.) are exempt.

2. Additional exemptions for otherwise covered strains will be

considered when CDC reviews and updates the list of select agents in

this Appendix. Individuals seeking an exemption should submit a request

to CDC that specifies the agent or strain to be exempted and explains

why such an exemption should be granted. Future exemptions will be

published in the Federal Register for review and comment prior to

inclusion in this Appendix.

[FR Doc. 96-27082 Filed 10-23-96; 8:45 am]

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