[Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
[Rules and Regulations]
[Pages 55190-55200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27082]
[[Page 55189]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Centers for Disease Control and Prevention
_______________________________________________________________________
42 CFR Part 72
Additional Requirements for Facilities Transferring or Receiving Select
Agents; Final Rule
Federal Register / Vol. 61, No. 207 / Thursday, October 24, 1996 /
Rules and Regulations
[[Page 55190]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
42 CFR Part 72
RIN 0905-AE70
Additional Requirements for Facilities Transferring or Receiving
Select Agents
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
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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
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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]
BILLING CODE 4160-18-M
