Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review, Technical Amendment, 26860-26862 [2014-10740]
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26860
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations
signs) a joint resolution of disapproval,
described under section 802.
Another statutory provision that may
affect this rule is CERCLA section 305,
which provides for a legislative veto of
regulations promulgated under
CERCLA. Although INS v. Chadha, 462
U.S. 919,103 S. Ct. 2764 (1983), and Bd.
of Regents of the University of
Washington v. EPA, 86 F.3d 1214,1222
(D.C. Cir. 1996), cast the validity of the
legislative veto into question, the EPA
has transmitted a copy of this regulation
to the Secretary of the Senate and the
Clerk of the House of Representatives.
If action by Congress under either the
CRA or CERCLA section 305 calls the
effective date of this regulation into
question, the EPA will publish a
document of clarification in the Federal
Register.
List of Subjects in 40 CFR Part 300
Environmental protection, Air
pollution control, Chemicals, Hazardous
substances, Hazardous waste,
Intergovernmental relations, Natural
resources, Oil pollution, Penalties,
Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
Dated: May 1, 2014.
Barry Breen,
Principal Deputy Assistant Administrator,
Office of Solid Waste and Emergency
Response.
For the reasons set out in this
preamble, 40 CFR part 300 is amended
as follows:
PART 300—NATIONAL OIL AND
HAZARDOUS SUBSTANCES
POLLUTION CONTINGENCY PLAN
Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C.
9601–9657; E.O. 12777, 56 FR 54757, 3 CFR,
1991 Comp., p. 351; E.O. 12580, 52 FR 2923,
3 CFR, 1987 Comp., p. 193.
Appendix B to Part 300—[Amended]
2. Table 1 of Appendix B to Part 300
by adding entries for ‘‘MacMillan Ring
Free Oil’’, ‘‘Keddy Mill’’, ‘‘PCE
Southeast Contamination’’, ‘‘PCE/TCE
Northeast Contamination’’, ‘‘Unimatic
Manufacturing Corporation’’, ‘‘WolffAlport Chemical Company’’, and
‘‘Walker Machine Products, Inc.’’ in
alphabetical order by state.
The additions read as follows:
■
Appendix B to Part 300—National
Priorities List
1. The authority citation for Part 300
continues to read as follows:
■
TABLE 1—GENERAL SUPERFUND SECTION
State
Site name
City/County
Notes a
*
AR .......................
*
*
*
*
MacMillan Ring Free Oil .......................................................................... Norphlet.
*
*
*
ME ......................
*
*
*
*
Keddy Mill ................................................................................................ Windham.
*
*
*
NE .......................
NE .......................
*
*
*
*
PCE Southeast Contamination ............................................................... York.
PCE/TCE Northeast Contamination ........................................................ York.
*
*
*
NJ .......................
*
*
*
*
Unimatic Manufacturing Corporation ....................................................... Fairfield.
*
*
*
NY .......................
*
*
*
*
Wolff-Alport Chemical Company ............................................................. Ridgewood.
*
*
*
TN .......................
*
*
*
*
Walker Machine Products, Inc. ............................................................... Collierville.
*
*
*
*
*
*
*
*
*
a = Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS score need not be greater
than or equal to 28.50).
*
*
*
*
*
[FR Doc. 2014–10831 Filed 5–9–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 6560–50–P
42 CFR Part 73
emcdonald on DSK67QTVN1PROD with RULES
RIN 0920–AA34
Possession, Use, and Transfer of
Select Agents and Toxins; Biennial
Review, Technical Amendment
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Final rule; technical
amendment.
AGENCY:
VerDate Mar<15>2010
16:04 May 09, 2014
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In a final rule that was
published in the Federal Register on
October 5, 2012, we amended and
republished the list of select agents and
toxins that have the potential to pose a
severe threat to public health and safety;
reorganized the list of select agents and
toxins based on the relative potential of
each select agent or toxin to be misused
to adversely affect human health
(designation of Tier 1); and amended the
regulations in order to add definitions
and clarify language concerning
security, training, biosafety,
biocontainment, and incident response.
In that final rule, all of our regulatory
SUMMARY:
E:\FR\FM\12MYR1.SGM
12MYR1
emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations
language was not precisely aligned with
that used by the Animal and Plant
Health Inspection Service (APHIS), U.S.
Department of Agriculture (USDA) in
their parallel select agent regulations
published on the same day in the
Federal Register. This document
corrects inconsistencies in language
between the HHS/CDC and USDA/
APHIS regulations. We are also
correcting an improper term used in
those sections of the regulations
associated with identification of a viral
strain or subspecies that is excluded
from the requirements of the
regulations, modifying the terms used
when a select toxin is excluded from the
regulations, clarifying those parts of the
regulations that deal with temporary
exemptions granted during periods of
public health or agricultural
emergencies, and adding language to
specify that individuals not approved
for unescorted access to registered space
for activities not related to select agents
or toxins (e.g., routine cleaning,
maintenance, and repairs) would not
have to be continuously escorted by an
approved individual so long as those
non-approved persons would not be
able to gain access to select agents or
toxins.
DATES: Effective Date: May 12, 2014.
FOR FURTHER INFORMATION CONTACT:
Robbin Weyant, Director, Division of
Select Agents and Toxins, Centers for
Disease Control and Prevention, 1600
Clifton Rd. NE., MS A–46, Atlanta, GA
30329. Telephone: (404) 718–2000.
SUPPLEMENTARY INFORMATION: On
October 5, 2012, HHS/CDC and USDA/
APHIS published parallel Final Rules in
the Federal Register (77 FR 61084 and
77 FR 61056, respectively) amending
and republishing the list of select agents
and toxins as required by the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002.
Because of the overlapping nature of the
regulatory requirements, HHS/CDC and
USDA/APHIS strive to establish
identical language in their respective
regulations wherever possible. A post
publication review of the regulatory
language of both rules identified
sections in which the regulatory
language used by HHS/CDC was not
precisely aligned with that used by
USDA/APHIS.
In addition, we are also clarifying a
term used in § 73.3(d)(5) and
§ 73.4(d)(3), which addresses the
circumstances in which a virus strain or
agent subspecies is excluded from the
requirements set out in the regulations.
Specifically, these paragraphs need to
clearly identify those strains of viruses
and subspecies of agents that we do not
VerDate Mar<15>2010
16:04 May 09, 2014
Jkt 232001
consider to have the potential to pose a
severe threat to public health and safety.
As published, these sections allowed
the listed specific virus strains and
agent subspecies to be excluded from
the requirements of the select agent
regulations provided that an entity
could ‘‘verify’’ that the virus strain or
agent subspecies in their possession was
within the listed strain or subspecies.
We are replacing the word ‘‘verify’’ with
the word ‘‘identify,’’ as identification is
a more precise description of the
categorization of a viral strain or
subspecies of agent. We note that before
one can verify, one must identify. The
following changes are made to correct
the discrepancies in language in order to
fully harmonize the regulations, to
replace ‘‘verify’’ with the proper term
‘‘identify’’, and to clarify that a person
without approval to have access to
select agents and toxins needs to be
continuously escorted only if that
person will have the ability to gain
access to select agents or toxins.
We are also clarifying terms used in
§ 73.3(e), § 73.3(e)(2), and § 73.4(e),
§ 73.4(e)(2), which addressed the
circumstances under which select
toxins may be excluded from the
requirements of the regulations. In these
sections, we are replacing the words
‘‘inactive’’ and ‘‘inactivated’’ with the
phrase ‘‘modified to be less toxic or
potent.’’ This is necessary because a
select toxin may be modified to be less
toxic or potent in such a way that it
loses some but not necessarily all
functional activity (e.g., modifying a
toxin by chemical, genetic, or other
means such that the toxin still retains
some of its toxic activity). By
comparison, an inactive select toxin is
completely non-functional. For the
purposes of regulatory applicability,
before a select toxin will be considered
‘‘modified to be less toxic or potent,’’ a
written request and supporting
scientific information must be
submitted to either HHS/CDC or USDA/
APHIS so that a determination on
whether to exclude the less toxic or
potent select toxin can be made by the
HHS Secretary.
Paragraphs 73.6(e) and (f) address
temporary exemptions to all or part of
the regulations concerning select agents
and toxins which may be granted by the
HHS Secretary to respond to a public
health emergency. We are amending the
language in order to clarify that entities
will not request these exemptions, as is
the case with the other potential
exemptions listed in § 73.6, since the
decision regarding whether to issue
‘‘public health emergency’’ exemptions
is predicated on an initial determination
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26861
by the HHS Secretary of the existence of
a public health emergency.
Finally, § 73.11(d)(2) makes clear that
individuals not approved for access to
select agents and toxins may have
access to registered space for activities
not related to select agents or toxins
(e.g., routine cleaning, maintenance, and
repairs) without being continuously
escorted by an approved individual so
long as those non-approved individuals
will not be able to gain access to select
agents or toxins.
List of Subjects in 42 CFR Part 73
Biologics, Packaging and containers,
Penalties, Reporting and recordkeeping
requirements, Transportation.
Accordingly, 42 CFR part 73 is
corrected by making the following
correcting amendments:
PART 73— SELECT AGENTS AND
TOXINS
1. The authority citation for part 73
continues to read as follows:
■
Authority: 42 U.S.C. 262a; sections 201–
204, 221 and 231 of Title II of Public Law
107–188, 116 Stat. 637 (42 U.S.C. 262a).
2. In § 73.3:
a. Paragraph (d)(5) is amended by
removing the word ‘‘verify’’ and adding
the word ‘‘identify’’ in its place.
■ b. Paragraph (e) introductory text is
revised.
■ c. Paragraph (e)(2) is amended by
removing the word ‘‘inactivated’’ and
adding the word ‘‘modified’’ in its
place.
The revision reads as follows:
■
■
§ 73.3
HHS select agents and toxins.
*
*
*
*
*
(e) An attenuated strain of a select
agent or a select toxin modified to be
less potent or toxic may be excluded
from the requirements of this part based
upon a determination by the HHS
Secretary that the attenuated strain or
modified toxin does not pose a severe
threat to public health and safety.
*
*
*
*
*
■ 3. In § 73.4:
■ a. Paragraph (d)(3) is amended by
removing the word ‘‘verify’’ and adding
the word ‘‘identify’’ in its place.
■ b. Paragraph (e) introductory text is
revised.
■ c. Paragraph (e)(2) is amended by
removing the word ‘‘inactivated’’ and
adding the word ‘‘modified’’ in its
place.
■ d. Paragraph (f)(3)(i) is amended by
adding the word ‘‘overlap’’ before
‘‘select agent or toxin.’’
The revision reads as follows:
E:\FR\FM\12MYR1.SGM
12MYR1
26862
§ 73.4
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations
Overlap select agents and toxins.
*
*
*
*
*
(e) An attenuated strain of a select
agent, or a select toxin modified to be
less potent or toxic, may be excluded
from the requirements of this part based
upon a determination by the HHS
Secretary that the attenuated strain or
modified toxin does not pose a severe
threat to public health and safety.
*
*
*
*
*
■ 4. In § 73.6, revise paragraphs (e) and
(f) to read as follows:
§ 73.6 Exemptions for overlap select
agents and toxins.
*
*
*
*
*
(e) The HHS Secretary may exempt an
individual or entity from the
requirements of this part based on a
determination that the exemption is
necessary to provide for the timely
participation of the individual or entity
in response to a domestic or foreign
public health emergency. The HHS
Secretary may extend the exemption
once for additional 30 days.
(f) Upon request of the Administrator,
the HHS Secretary may exempt an
individual or entity from the
requirements, in whole or in part, of this
part for 30 calendar days if the
Administrator has granted the
exemption for agricultural emergency.
The HHS Secretary may extend the
exemption once for an additional 30
calendar days.
■ 5. Section 73.11 is amended as
follows:
■ a. In paragraph (c)(2), remove the
commas before ‘‘including’’ and after
‘‘arthropods’’ and put parentheses
around the words ‘‘including
arthropods’’ after the word ‘‘animals.’’
■ b. Revise paragraph (c)(9)(iii).
■ c. In paragraph (d)(2) by adding ‘‘if the
potential for access to select agents or
toxins exists’’ after ‘‘approved
individual.’’
■ d. Revise paragraph (f)(4)(viii)(A).
■ e. Revise paragraph (g).
The revisions read as follows:
§ 73.11
Security.
emcdonald on DSK67QTVN1PROD with RULES
*
*
*
*
*
(c) * * *
(9) * * *
(iii) Ensure that controls are in place
that are designed to prevent malicious
code (such as, but not limited to,
computer virus, worms, spyware) from
compromising the confidentiality,
integrity, or availability of information
systems which manage access to spaces
registered under this part or records in
§ 73.17;
*
*
*
*
*
(f) * * *
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(4) * * *
(iv) * * *
(A) Determine that the response time
for security forces or local police will
not exceed 15 minutes where the
response time is measured from the time
of an intrusion alarm, or report of a
security incident, to the arrival of the
responders at the first security barrier
or;
*
*
*
*
*
(g) In developing a security plan, an
individual or entity should consider the
document entitled, ‘‘Security Guidance
for Select Agent or Toxin Facilities.’’
This document is available on the
National Select Agent Registry at
https://www.selectagents.gov/.
*
*
*
*
*
■ 6. Section 73.13 is amended as
follows:
■ a. By revising paragraph (a).
■ b. By removing paragraph (b).
■ c. By redesignating paragraphs (c) and
(d) as paragraphs (b) and (c),
respectively.
■ d. In newly redesignated paragraph
(b), by removing the words ‘‘paragraph
(b)’’ and adding the words ‘‘paragraph
(a)’’ in their place.
The additions read as follows:
§ 73.13
Restricted experiments.
(a) An individual or entity may not
conduct, or possess products resulting
from, the following experiments unless
approved by and conducted in
accordance with the conditions
prescribed by the HHS Secretary:
(1) Experiments that involve the
deliberate transfer of, or selection for, a
drug resistance trait to select agents that
are not known to acquire the trait
naturally, if such acquisition could
compromise the control of disease
agents in humans, veterinary medicine,
or agriculture.
(2) Experiments involving the
deliberate formation of synthetic or
recombinant DNA containing genes for
the biosynthesis of select toxins lethal
for vertebrates at an LD[50] <100 ng/kg
body weight.’’
*
*
*
*
*
§ 73.16
[Amended]
7. In § 73.16, paragraph (g) is amended
by removing the words ‘‘concerning
shipping’’ and adding ‘‘governing
packaging and shipping’’ after the words
‘‘applicable laws’’.
■
Dated: May 6, 2014.
Kathleen Sebelius,
Secretary.
[FR Doc. 2014–10740 Filed 5–9–14; 8:45 am]
BILLING CODE 4163–18–P
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FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 1
[WT Docket No. 03–128; FCC 04–222]
The Nationwide Programmatic
Agreement Regarding Section 106
National Historic Preservation Act
Review Process, Advisory Council on
Historic Preservation
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the
Commission announces that the Office
of Management and Budget (OMB) has
approved, until October 31, 2014, an
emergency information collection
associated with the Nationwide
Programmatic Agreement Regarding the
Section 106 National Historic
Preservation Act Review Process. With
this document, the Commission is
announcing OMB approval and the
effective date of the revised
requirements.
SUMMARY:
FCC Forms 620, 621 and the
Tower Construction Notification System
were approved by OMB on April 9, 2014
and are effective on May 16, 2014.
FOR FURTHER INFORMATION CONTACT: For
additional information contact Cathy
Williams, Cathy.Williams@fcc.gov
<mailto:Cathy.Williams@fcc.gov>, (202)
418–2918.
SUPPLEMENTARY INFORMATION: This
document announces that, on April 9,
2014, OMB approved the revised
information collection requirements for
Nationwide Programmatic Agreement
Regarding the Section 106 National
Historic Preservation Act Review
Process published at 70 FR 556, January
4, 2005. The OMB Control Number is
3060–1039. The Commission publishes
this notice as an announcement of the
effective date of the requirements. If you
have any comments on the burden
estimates listed below, or how the
Commission can improve the
collections and reduce any burdens
caused thereby, please contact Cathy
Williams, Federal Communications
Commission, Room 1–C823, 445 12th
Street SW., Washington, DC 20554.
Please include the OMB Control
Number, 3060–1039, in your
correspondence. The Commission will
also accept your comments via the
Internet if you send them to PRA@
fcc.gov <mailto:PRA@fcc.gov>.
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
DATES:
E:\FR\FM\12MYR1.SGM
12MYR1
]]>Agencies
[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Rules and Regulations]
[Pages 26860-26862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10740]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
RIN 0920-AA34
Possession, Use, and Transfer of Select Agents and Toxins;
Biennial Review, Technical Amendment
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: In a final rule that was published in the Federal Register on
October 5, 2012, we amended and republished the list of select agents
and toxins that have the potential to pose a severe threat to public
health and safety; reorganized the list of select agents and toxins
based on the relative potential of each select agent or toxin to be
misused to adversely affect human health (designation of Tier 1); and
amended the regulations in order to add definitions and clarify
language concerning security, training, biosafety, biocontainment, and
incident response. In that final rule, all of our regulatory
[[Page 26861]]
language was not precisely aligned with that used by the Animal and
Plant Health Inspection Service (APHIS), U.S. Department of Agriculture
(USDA) in their parallel select agent regulations published on the same
day in the Federal Register. This document corrects inconsistencies in
language between the HHS/CDC and USDA/APHIS regulations. We are also
correcting an improper term used in those sections of the regulations
associated with identification of a viral strain or subspecies that is
excluded from the requirements of the regulations, modifying the terms
used when a select toxin is excluded from the regulations, clarifying
those parts of the regulations that deal with temporary exemptions
granted during periods of public health or agricultural emergencies,
and adding language to specify that individuals not approved for
unescorted access to registered space for activities not related to
select agents or toxins (e.g., routine cleaning, maintenance, and
repairs) would not have to be continuously escorted by an approved
individual so long as those non-approved persons would not be able to
gain access to select agents or toxins.
DATES: Effective Date: May 12, 2014.
FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Director, Division of
Select Agents and Toxins, Centers for Disease Control and Prevention,
1600 Clifton Rd. NE., MS A-46, Atlanta, GA 30329. Telephone: (404) 718-
2000.
SUPPLEMENTARY INFORMATION: On October 5, 2012, HHS/CDC and USDA/APHIS
published parallel Final Rules in the Federal Register (77 FR 61084 and
77 FR 61056, respectively) amending and republishing the list of select
agents and toxins as required by the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. Because of the
overlapping nature of the regulatory requirements, HHS/CDC and USDA/
APHIS strive to establish identical language in their respective
regulations wherever possible. A post publication review of the
regulatory language of both rules identified sections in which the
regulatory language used by HHS/CDC was not precisely aligned with that
used by USDA/APHIS.
In addition, we are also clarifying a term used in Sec. 73.3(d)(5)
and Sec. 73.4(d)(3), which addresses the circumstances in which a
virus strain or agent subspecies is excluded from the requirements set
out in the regulations. Specifically, these paragraphs need to clearly
identify those strains of viruses and subspecies of agents that we do
not consider to have the potential to pose a severe threat to public
health and safety. As published, these sections allowed the listed
specific virus strains and agent subspecies to be excluded from the
requirements of the select agent regulations provided that an entity
could ``verify'' that the virus strain or agent subspecies in their
possession was within the listed strain or subspecies. We are replacing
the word ``verify'' with the word ``identify,'' as identification is a
more precise description of the categorization of a viral strain or
subspecies of agent. We note that before one can verify, one must
identify. The following changes are made to correct the discrepancies
in language in order to fully harmonize the regulations, to replace
``verify'' with the proper term ``identify'', and to clarify that a
person without approval to have access to select agents and toxins
needs to be continuously escorted only if that person will have the
ability to gain access to select agents or toxins.
We are also clarifying terms used in Sec. 73.3(e), Sec.
73.3(e)(2), and Sec. 73.4(e), Sec. 73.4(e)(2), which addressed the
circumstances under which select toxins may be excluded from the
requirements of the regulations. In these sections, we are replacing
the words ``inactive'' and ``inactivated'' with the phrase ``modified
to be less toxic or potent.'' This is necessary because a select toxin
may be modified to be less toxic or potent in such a way that it loses
some but not necessarily all functional activity (e.g., modifying a
toxin by chemical, genetic, or other means such that the toxin still
retains some of its toxic activity). By comparison, an inactive select
toxin is completely non-functional. For the purposes of regulatory
applicability, before a select toxin will be considered ``modified to
be less toxic or potent,'' a written request and supporting scientific
information must be submitted to either HHS/CDC or USDA/APHIS so that a
determination on whether to exclude the less toxic or potent select
toxin can be made by the HHS Secretary.
Paragraphs 73.6(e) and (f) address temporary exemptions to all or
part of the regulations concerning select agents and toxins which may
be granted by the HHS Secretary to respond to a public health
emergency. We are amending the language in order to clarify that
entities will not request these exemptions, as is the case with the
other potential exemptions listed in Sec. 73.6, since the decision
regarding whether to issue ``public health emergency'' exemptions is
predicated on an initial determination by the HHS Secretary of the
existence of a public health emergency.
Finally, Sec. 73.11(d)(2) makes clear that individuals not
approved for access to select agents and toxins may have access to
registered space for activities not related to select agents or toxins
(e.g., routine cleaning, maintenance, and repairs) without being
continuously escorted by an approved individual so long as those non-
approved individuals will not be able to gain access to select agents
or toxins.
List of Subjects in 42 CFR Part 73
Biologics, Packaging and containers, Penalties, Reporting and
recordkeeping requirements, Transportation.
Accordingly, 42 CFR part 73 is corrected by making the following
correcting amendments:
PART 73-- SELECT AGENTS AND TOXINS
0
1. The authority citation for part 73 continues to read as follows:
Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of
Title II of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a).
0
2. In Sec. 73.3:
0
a. Paragraph (d)(5) is amended by removing the word ``verify'' and
adding the word ``identify'' in its place.
0
b. Paragraph (e) introductory text is revised.
0
c. Paragraph (e)(2) is amended by removing the word ``inactivated'' and
adding the word ``modified'' in its place.
The revision reads as follows:
Sec. 73.3 HHS select agents and toxins.
* * * * *
(e) An attenuated strain of a select agent or a select toxin
modified to be less potent or toxic may be excluded from the
requirements of this part based upon a determination by the HHS
Secretary that the attenuated strain or modified toxin does not pose a
severe threat to public health and safety.
* * * * *
0
3. In Sec. 73.4:
0
a. Paragraph (d)(3) is amended by removing the word ``verify'' and
adding the word ``identify'' in its place.
0
b. Paragraph (e) introductory text is revised.
0
c. Paragraph (e)(2) is amended by removing the word ``inactivated'' and
adding the word ``modified'' in its place.
0
d. Paragraph (f)(3)(i) is amended by adding the word ``overlap'' before
``select agent or toxin.''
The revision reads as follows:
[[Page 26862]]
Sec. 73.4 Overlap select agents and toxins.
* * * * *
(e) An attenuated strain of a select agent, or a select toxin
modified to be less potent or toxic, may be excluded from the
requirements of this part based upon a determination by the HHS
Secretary that the attenuated strain or modified toxin does not pose a
severe threat to public health and safety.
* * * * *
0
4. In Sec. 73.6, revise paragraphs (e) and (f) to read as follows:
Sec. 73.6 Exemptions for overlap select agents and toxins.
* * * * *
(e) The HHS Secretary may exempt an individual or entity from the
requirements of this part based on a determination that the exemption
is necessary to provide for the timely participation of the individual
or entity in response to a domestic or foreign public health emergency.
The HHS Secretary may extend the exemption once for additional 30 days.
(f) Upon request of the Administrator, the HHS Secretary may exempt
an individual or entity from the requirements, in whole or in part, of
this part for 30 calendar days if the Administrator has granted the
exemption for agricultural emergency. The HHS Secretary may extend the
exemption once for an additional 30 calendar days.
0
5. Section 73.11 is amended as follows:
0
a. In paragraph (c)(2), remove the commas before ``including'' and
after ``arthropods'' and put parentheses around the words ``including
arthropods'' after the word ``animals.''
0
b. Revise paragraph (c)(9)(iii).
0
c. In paragraph (d)(2) by adding ``if the potential for access to
select agents or toxins exists'' after ``approved individual.''
0
d. Revise paragraph (f)(4)(viii)(A).
0
e. Revise paragraph (g).
The revisions read as follows:
Sec. 73.11 Security.
* * * * *
(c) * * *
(9) * * *
(iii) Ensure that controls are in place that are designed to
prevent malicious code (such as, but not limited to, computer virus,
worms, spyware) from compromising the confidentiality, integrity, or
availability of information systems which manage access to spaces
registered under this part or records in Sec. 73.17;
* * * * *
(f) * * *
(4) * * *
(iv) * * *
(A) Determine that the response time for security forces or local
police will not exceed 15 minutes where the response time is measured
from the time of an intrusion alarm, or report of a security incident,
to the arrival of the responders at the first security barrier or;
* * * * *
(g) In developing a security plan, an individual or entity should
consider the document entitled, ``Security Guidance for Select Agent or
Toxin Facilities.'' This document is available on the National Select
Agent Registry at https://www.selectagents.gov/.
* * * * *
0
6. Section 73.13 is amended as follows:
0
a. By revising paragraph (a).
0
b. By removing paragraph (b).
0
c. By redesignating paragraphs (c) and (d) as paragraphs (b) and (c),
respectively.
0
d. In newly redesignated paragraph (b), by removing the words
``paragraph (b)'' and adding the words ``paragraph (a)'' in their
place.
The additions read as follows:
Sec. 73.13 Restricted experiments.
(a) An individual or entity may not conduct, or possess products
resulting from, the following experiments unless approved by and
conducted in accordance with the conditions prescribed by the HHS
Secretary:
(1) Experiments that involve the deliberate transfer of, or
selection for, a drug resistance trait to select agents that are not
known to acquire the trait naturally, if such acquisition could
compromise the control of disease agents in humans, veterinary
medicine, or agriculture.
(2) Experiments involving the deliberate formation of synthetic or
recombinant DNA containing genes for the biosynthesis of select toxins
lethal for vertebrates at an LD[50] <100 ng/kg body weight.''
* * * * *
Sec. 73.16 [Amended]
0
7. In Sec. 73.16, paragraph (g) is amended by removing the words
``concerning shipping'' and adding ``governing packaging and shipping''
after the words ``applicable laws''.
Dated: May 6, 2014.
Kathleen Sebelius,
Secretary.
[FR Doc. 2014-10740 Filed 5-9-14; 8:45 am]
BILLING CODE 4163-18-P
