[Federal Register Volume 66, Number 170 (Friday, August 31, 2001)]
[Rules and Regulations]
[Pages 45944-45945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22128]



[[Page 45944]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 72

RIN 0920-AA02


Requirements for Facilities Transferring or Receiving Select 
Agents

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: CDC administers regulations that govern the transfer of 
certain biological agents and toxins (``select agents''). These 
regulations require entities that transfer or receive select agents to 
register with CDC and comply with biosafety standards contained in the 
Third Edition of the CDC/NIH publication ``Biosafety in Microbiological 
and Biomedical Laboratories (``BMBL'').'' On October 28, 1999, CDC 
published a Notice of Proposed Rulemaking (``NPRM'') seeking both to 
revise the biosafety standards facilities must follow when handling 
select agents and to provide new biosecurity standards for such 
facilities. These new standards are contained in the Fourth Edition of 
BMBL, which the NPRM proposed to incorporate by reference, thereby 
replacing the Third Edition. No comments were received in response to 
this proposal. CDC is therefore amending its regulations to incorporate 
the Fourth Edition.

DATES: Effective date is January 1, 2002.

FOR FURTHER INFORMATION CONTACT: Laboratory Registration/Select Agent 
Transfer (LR/SAT) Program, Office of Health and Safety, Centers for 
Disease Control and Prevention (CDC), 1600 Clifton Road, NE., MS-A13, 
Atlanta, GA 30333; telephone (404) 639-4418; LR/SAT Program website at 
http://www.cdc.gov/od/ohs/lrsat.htm.

SUPPLEMENTARY INFORMATION:

Background

    ``The Antiterrorism and Effective Death Penalty Act of 1996,'' Pub. 
L. 104-132,(42 U.S.C. Sec. 262 note) enacted on April 24, 1996, 
established new provisions to regulate the transfer of certain 
biological agents and toxins (i.e., select agents), and required HHS to 
issue rules to implement these provisions. The final rule was published 
in the Federal Register on October 24, 1996 (61 FR 551990-01) and 
became effective April 15, 1997. To comply with the final rule, 
commercial suppliers of select agents, as well as government agencies, 
universities, research institutions, and private companies that 
transfer these agents, must register with the Centers for Disease 
Control and Prevention (CDC). Prior to transferring or receiving a 
select agent listed in Appendix A of 42 CFR part 72, the facility must 
be equipped and capable of handling the covered agent at Biosafety 
Level (BSL) 2, 3, or 4, depending on the agent. The requirements for 
BSL 2, 3, or 4 operations are contained in the CDC/NIH publication 
``Biosafety in Microbiological and Biomedical Laboratories'' (BMBL), 
and are currently incorporated by reference in the Third Edition. In 
May, 1999, the Fourth Edition of the BMBL was published. The Fourth 
Edition revises some of the biosafety standards contained in the Third 
Edition as a result of a number of events (e.g. emerging and re-
emerging infectious diseases, laboratory associated infections and 
advances in facility design and construction). The Fourth Edition also 
contains biosecurity standards, which have not been included in 
previous editions of the BMBL. These biosecurity provisions are 
intended to assure that registered entities take measures to prevent 
unauthorized use of agents and/or use of agents by unqualified persons. 
These measures are also designed to protect against theft of these 
agents thereby decreasing the likelihood that the agents may be used 
for nefarious purposes.
    On October 28, 1999, CDC published a Notice of Proposed Rulemaking 
(NPRM) seeking to replace the Third Edition of the BMBL with the 
recently published Fourth Edition (64 FR 58022). No comments were 
received in response to this proposed revision. This final rule 
therefore incorporates by reference the Fourth Edition.
    Effective January 1, 2002, all facilities subject to 42 CFR section 
72.6 are required to comply with the biosafety and biosecurity 
standards contained in the Fourth Edition. Facilities currently 
registered with CDC are therefore required to comply with the Fourth 
Edition as of January 1, 2002, but are not required to ``re-register'' 
until their registration expires as indicated on their current 
registration certificate.
    To assist facilities seeking registration, CDC has developed a new 
application form that contains the Fourth Edition requirements. CDC 
will use this form when registering all facilities after publication of 
this Final Rule. Facilities that register using the new form may 
continue to operate in accordance with the Third Edition of the BMBL 
until January 1, 2002.
    Because a large number of current registrations expire before 
January 1, 2002, facilities whose registration expires between the 
publication date of this final rule and January 1, 2002 must submit 
applications no later than October 1, 2001, in order to allow the 
Laboratory Registration/Select Agent Transfer Program office time to 
process the applications.
    CDC will mail revised applications to all facilities that express 
an interest. The revised application is also available on the LR/SAT 
Program website at http://www.cdc.gov/od/ohs/lrsat.htm. Questions about 
this Final Rule and requests for application packages should be faxed 
to CDC, Office of Health and Safety (404-639-0880) or sent by e-mail 
([email protected]). All applications for registration of facilities under 
this regulation should be mailed to: Centers for Disease Control and 
Prevention, Office of Health and Safety, Laboratory Registration/Select 
Agent Transfer Program, 1600 Clifton Road, MS A-13, Atlanta, Georgia 
30333.

Analysis of Impacts

    Under the Paperwork Reduction Act of 1995, a Federal agency shall 
not conduct or sponsor a collection of information from ten or more 
persons other than Federal employees unless the agency has submitted a 
Standard Form 83, Clearance Request, and Notice of Action, to the 
Director of the Office of Management and Budget (OMB), and the Director 
has approved the proposed collection of information. A person is not 
required to respond to a collection of information unless it displays a 
currently valid OMB control number. OMB has approved the information 
collection entitled `Importation of Etiological Agents and Packaging 
and Handling of Infectious Substances and Select Agents' and has 
assigned OMB control number 0920-0199. For further information on this 
information collection contact Anne O'Connor, CDC Assistant Reports 
Clearance Officer, Centers for Disease Control and Prevention, Office 
of Program Planning and Evaluation, 1600 Clifton Road, MS D-24, 
Atlanta, Georgia 30333, (404) 639-7090.
    The Unfunded Mandates Reform Act of 1995, in sections 202 and 205, 
requires Federal agencies to prepare several analytic statements before 
proposing a rule that may result in expenditures of $100 million by 
State, local, and tribal governments, or by the private sector in any 
one year. CDC addressed these concerns in the NPRM published on October 
28, 1999--Packaging and Handling of Infectious Substances and Select 
Agents (42 CFR part 72). Because a final rule resulting from this 
proposal would not result in

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expenditures of this magnitude, such statements are not necessary.
    The Regulatory Flexibility Act requires Federal agencies to prepare 
a regulatory flexibility analysis of the potential impact of the 
proposed rule on small entities and permits agency heads to certify 
that a proposed rule will not, if promulgated, have a significant 
economic impact on a substantial number of small entities. CDC also 
addressed these concerns in the NPRM published on October 28, 1999--
Packaging and Handling of Infectious Substances and Select Agents (42 
CFR part 72). CDC requested comments on the economic burden from a 
number of small entities. It also requested recommendations on other 
possible less burdensome approaches. No comments were received.

Federalism

    A rule has implications for federalism under Executive Order 13132, 
Federalism, if it has a substantial direct effect on State or local 
governments and would either preempt State law or impose a substantial 
direct cost of compliance on them. We have analyzed this rule under 
that Order and have determined that this rule does not have 
implications for federalism.

Taking of Private Property

    This rule would not effect a taking of private property or 
otherwise have taking implications under Executive Order 12630, 
Governmental Actions and Interference with Constitutionally Protected 
Property Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2) 
of Executive Order 12988, Civil Justice Reform, to minimize litigation, 
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection 
of Children from Environmental Health Risks and Safety Risks. This rule 
is not an economically significant rule and does not concern an 
environmental risk to health or risk to safety that may 
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order 
13175, Consultation and Coordination with Indian Tribal Governments, 
because it does not have a substantial direct effect on one or more 
Indian tribes, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.

Energy Effects

    This rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expected to affect energy supply, distribution, or use.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section 
3(f) of Executive Order 12866, Regulation Planning and Review, and does 
not require an assessment of potential costs and benefits under section 
6(a)(3) of that Order.

Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the Department 
will report to Congress promulgation of this rule prior to its 
effective date. The report will state that the Department has concluded 
that this rule is not a ``major rule'' because it is not likely to 
result in an annual effect on the economy of $100 million or more.

List of Subjects in 42 CFR Part 72

    Biologic, Incorporation by reference, Packaging and containers, 
Transportation.

Text of the Rule

    For the reasons stated in the preamble, part 72 is amended as 
follows:

PART 72--[AMENDED]

    1. The authority section for part 72 continues 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. Amend Sec. 72.6 by revising paragraphs (a)(5) and (c)(1) to read 
as follows:


Sec. 72.6   Additional requirements for facilities transferring or 
receiving select agents.

    (a) * * *
    (5) The biosafety standards and requirements for BSL-2, 3, and 4 
operations are contained in the CDC/NIH publication, ``Biosafety in 
Microbiological and Biomedical Laboratories,'' Fourth Edition, May 1999 
which is hereby incorporated by reference. The Director of the Federal 
Register has approved under 5 U.S.C. 552(a) and 1 CFR 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, DC 20402. Copies may be inspected at the Centers 
for Disease Control and Prevention, 1600 Clifton Road, Mail Stop A-13 
Atlanta, Georgia, or at the Office of the Federal Register, 800 North 
Capitol Street NW, Suite 700, Washington, DC. The manual is also 
available on the CDC web site at www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm.
* * * * *
    (c) * * *
    (1) the Secretary may authorize a state agency or private entity to 
register facilities under paragraph (a) of this section, if the 
Secretary determines that the registering entity's criteria for 
determining the biosafety standards for facilities handling select 
agents are consistent with the requirements contained in the CDC/NIH 
publication ``Biosafety in Microbiological and Biomedical 
Laboratories,'' Fourth Edition.
* * * * *

    Dated: August 16, 2001.
Jeffrey Koplan,
Director, Centers for Disease Control and Prevention.
    Dated: August 29, 2001.
Tommy G. Thompson,
Secretary, Department of Health and Human Services.
[FR Doc. 01-22128 Filed 8-30-01; 8:45 am]
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