Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations; Technical Amendment, 26829-26831 [2014-10741]
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26829
Rules and Regulations
Federal Register
Vol. 79, No. 91
Monday, May 12, 2014
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
7 CFR Part 331
9 CFR Part 121
[Docket No. APHIS–2009–0070]
Agricultural Bioterrorism Protection
Act of 2002; Biennial Review and
Republication of the Select Agent and
Toxin List; Amendments to the Select
Agent and Toxin Regulations;
Technical Amendment
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule; technical
amendment.
AGENCY:
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 animal or plant health,
or to animal or plant products;
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, plant, or
animal health; and amended the
regulations in order to add definitions
and clarify language concerning
security, training, biosafety,
biocontainment, and incident response.
In that final rule we neglected to
precisely align all of our regulatory
language with that used by the Centers
for Disease Control and Prevention
(CDC) in their regulations and, in some
cases, did not align our language in the
Animal and Plant Health Inspection
Service (APHIS) regulations concerning
plant health and plant products with
that concerning animal health and
animal products. As APHIS coadministers the select agent regulations
with CDC, this document corrects
emcdonald on DSK67QTVN1PROD with RULES
SUMMARY:
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inconsistencies in language between
APHIS and CDC 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
agricultural or public health
emergencies, and adding language to
specify that individuals not approved
for 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: Dr.
Charles L. Divan, Unit Director, APHIS
Agriculture Select Agent Services,
APHIS, 4700 River Road Unit 2,
Riverdale, MD 20737–1231; (301) 851–
3300, option 3.
SUPPLEMENTARY INFORMATION: The
Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
(referred to below as the Bioterrorism
Response Act) provides for the
regulation of certain biological agents
that have the potential to pose a severe
threat to both human and animal health,
to animal health, to plant health, or to
animal and plant products. The Animal
and Plant Health Inspection Service
(APHIS) has the primary responsibility
for implementing the provisions of the
Act within the U.S. Department of
Agriculture (USDA). Veterinary Services
(VS) select agents and toxins are those
that have been determined to have the
potential to pose a severe threat to
animal health or animal products. Plant
Protection and Quarantine (PPQ) select
agents and toxins are those that have the
potential to pose a severe threat to plant
health or plant products. Overlap select
agents and toxins are those that have
been determined to pose a severe threat
to both human and animal health or
animal products. Overlap select agents
are subject to regulation by both APHIS
and the Centers for Disease Control and
Prevention (CDC), which has the
primary responsibility for implementing
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the provisions of the Act for the
Department of Health and Human
Services (HHS).
We use the term ‘‘select agents and
toxins’’ throughout the preamble of this
technical amendment. Unless otherwise
specified, the term ‘‘select agents and
toxins’’ will refer to all agents or toxins
listed by APHIS. When it is necessary to
specify the type of select agent or toxin,
we will use the following terms: ‘‘PPQ
select agents and toxins’’ (for the plant
agents and toxins listed in 7 CFR 331.3),
‘‘VS select agents and toxins’’ (for the
animal agents and toxins listed in 9 CFR
121.3), or ‘‘overlap select agents and
toxins’’ (for the agents and toxins listed
in both 9 CFR 121.4 and 42 CFR 73.4).
On October 5, 2012, we published in
the Federal Register (77 FR 61056–
61081, Docket No. APHIS–2009–0070) a
final rule 1 that amended and
republished the list of select agents and
toxins that have the potential to pose a
severe threat to animal or plant health,
or to animal or plant products;
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, plant, or
animal health; and amended the
regulations in order to add definitions
and clarify language concerning
security, training, biosafety,
biocontainment, and incident response.
Concurrently, CDC published a final
rule amending and republishing the list
of select agents that have the potential
to pose a severe threat to human health.
APHIS and CDC worked to establish
identical language in their respective
regulations wherever possible. Within
APHIS, we also aimed to maintain
consistency between the VS and PPQ
select agent regulations. The current
action is necessary to correct the
discrepancies in language in order to
fully harmonize the regulations.
We are also clarifying a term used in
the PPQ select agents and toxins
regulations in § 331.3(d)(3) and the VS
and overlap select agents and toxins
regulations in §§ 121.3(d)(3) and
121.4(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 do not
1 To view the final rule, its preceding proposed
rule, and the comments we received, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2009-0070.
E:\FR\FM\12MYR1.SGM
12MYR1
emcdonald on DSK67QTVN1PROD with RULES
26830
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations
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 both human and animal
health, to animal health, to plant health,
or to animal and plant products. These
sections allow the listed virus strains
and agent subspecies to be excluded
from the requirements of the regulations
provided that an entity can verify that
the virus or agent in their possession is
within the listed strain or subspecies. In
this amendment, we are replacing the
word ‘‘verify’’ with the word ‘‘identify,’’
as identification must occur prior to
verification of a viral strain or
subspecies of agent.
Sections 331.3(e), 121.3(e), and
121.4(e) concern the circumstances
under which attenuated strains of select
agents or inactive 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 in order to cover a broader
category of toxins. 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. By
comparison, an inactive select toxin is
completely non-functional. A written
request and supporting scientific
information would have to be submitted
for toxins that have been modified to be
less toxic or potent and a determination
of whether to exclude the submitted
toxin would be made by the
Administrator.
Paragraphs 121.6(e) and (f) involve
temporary exemptions to all or part of
the regulations concerning overlap
select agents and toxins, which may be
granted by the Administrator or
requested by the HHS Secretary in the
event of an agricultural or public health
emergency. We are amending the
language in order to clarify that entities
do not have to request these
exemptions, as is the case with the other
potential exemptions listed in § 121.6,
since the decision regarding whether to
issue exemptions is predicated on an
independent determination of the
existence of such an emergency by the
Administrator or HHS Secretary.
Finally, § 331.11(d)(2) and
§ 121.11(d)(2) require that individuals
not approved by the Administrator or
the HHS Secretary for access to
registered space for activities not related
to select agents or toxins (e.g., routine
cleaning, maintenance, and repairs) be
continuously escorted by an approved
individual. We are adding language to
clarify that continuous escort is required
only if those non-approved persons
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could potentially gain access to select
agents or toxins.
List of Subjects
b. In paragraph (g), by removing the
word ‘‘documents’’ and adding the word
‘‘document’’ in its place.
7 CFR Part 331
§ 331.12
Agricultural research, Laboratories,
Plant diseases and pests, Reporting and
recordkeeping requirements.
■
9 CFR Part 121
Agricultural research, Animal
diseases, Laboratories, Medical research,
Reporting and recordkeeping
requirements.
Accordingly, we are amending 7 CFR
part 331 and 9 CFR part 121 as follows:
TITLE 7—AGRICULTURE
PART 331— POSSESSION, USE, AND
TRANSFER OF SELECT AGENTS AND
TOXINS
1. The authority citation for part 331
continues to read as follows:
■
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,
and 371.3.
§ 331.1
[Amended]
2. Section 331.1 is amended as
follows:
■ a. In paragraph (1) of the definition of
recombinant nucleic acids, by removing
the words ‘‘(i.e., recombinant nucleic
acids)’’.
■ b. In the definition of security barrier,
by removing the words ‘‘, animals, or
materials’’.
■ 3. Section 331.3 is amended as
follows:
■ a. In paragraph (d)(3), by removing the
word ‘‘verify’’ and adding the word
‘‘identify’’ in its place.
■ b. By revising paragraph (e)
introductory text.
■ c. In paragraph (e)(2), by removing the
word ‘‘inactivated’’ and adding the
word ‘‘modified’’ in its place.
The revision reads as follows:
■
§ 331.3
PPQ 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
Administrator that the attenuated strain
or modified toxin does not pose a severe
threat to plant health or plant products.
*
*
*
*
*
§ 331.11
[Amended]
4. Section 331.11 is amended as
follows:
■ a. In paragraph (d)(2), by adding the
words ‘‘if the potential to access to
select agents or toxins exists’’ after the
words ‘‘approved individual’’.
■
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■
[Amended]
5. In § 331.12, paragraph (a) is
amended by adding the words
‘‘(including arthropods)’’ after the words
‘‘including any animals’’.
§ 331.13
[Amended]
6. In § 331.13, paragraph (a)
introductory text is amended by
removing both commas.
■
TITLE 9—ANIMALS AND ANIMAL
PRODUCTS
PART 121—POSSESSION, USE, AND
TRANSFER OF SELECT AGENTS AND
TOXINS
7. The authority citation for part 121
continues to read as follows:
■
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80,
and 371.4.
8. Section 121.3 is amended as
follows:
■ a. In paragraph (d)(3), by removing the
word ‘‘verify’’ and adding the word
‘‘identify’’ in its place.
■ b. By revising paragraph (e)
introductory text.
■ c. In paragraph (e)(2), by removing the
word ‘‘inactivated’’ and adding the
word ‘‘modified’’ in its place.
The revision reads as follows:
■
§ 121.3
VS 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
Administrator that the attenuated strain
or modified toxin does not pose a severe
threat to animal health or animal
products.
*
*
*
*
*
■ 9. Section 121.4 is amended as
follows:
■ a. In paragraph (d)(3), by removing the
word ‘‘verify’’ and adding the word
‘‘identify’’ in its place.
■ b. By revising paragraph (e)
introductory text.
■ c. In paragraph (e)(2) by removing the
word ‘‘inactivated’’ and adding the
word ‘‘modified’’ in its place.
■ d. In paragraph (f)(3)(i), first sentence,
by removing the second occurrence of
the word ‘‘and’’ and adding the word
‘‘or’’ in its place.
The revision reads as follows:
§ 121.4
Overlap select agents and toxins.
*
*
*
*
*
(e) An attenuated strain of a select
agent or a select toxin modified to be
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12MYR1
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations
less potent or toxic may be excluded
from the requirements of this part based
upon a determination by the
Administrator that the attenuated strain
or modified toxin does not pose a severe
threat to public health and safety,
animal health, or animal products.
*
*
*
*
*
§ 121.5
[Amended]
10. In § 121.5, paragraph (a)(3)(i) is
amended by removing the words ‘‘and
swine’’ and adding the words ‘‘or
swine’’ in their place.
■ 11. Section 121.6 is amended as
follows:
■ a. In paragraph (a)(3)(i), by removing
the second occurrence of the word
‘‘and’’ and adding the word ‘‘or’’ in its
place.
■ b. By revising paragraphs (e) and (f).
The revisions read as follows:
■
§ 121.6 Exemptions for overlap select
agents and toxins.
*
*
*
*
*
(e) If it is necessary to respond to a
domestic or foreign agricultural
emergency involving an overlap select
agent or toxin, the Administrator may
exempt an individual or entity from the
requirements, in whole or in part, of this
part for up to 30 calendar days. The
Administrator may extend the
exemption once for an additional 30
days.
(f) Upon request of the Secretary of
Health and Human Services, the
Administrator may exempt an
individual or entity from the
requirements, in whole or in part, of this
part for up to 30 calendar days if the
Secretary of Health and Human Services
has granted an exemption for a public
health emergency involving an overlap
select agent or toxin. The Administrator
may extend the exemption once for an
additional 30 days.
§ 121.9
[Amended]
12. In § 121.9, paragraph (c)(1) is
amended by removing the words ‘‘and
swine’’ and adding the words ‘‘or
swine’’ in their place.
■
§ 121.11
[Amended]
13. Section 121.11 is amended as
follows:
■ a. In paragraph (c)(2), by adding the
words ‘‘(including arthropods)’’ after the
word ‘‘animals’’.
■ b. In paragraph (d)(2), by adding the
words ‘‘if the potential to access to
select agents or toxins exists’’ after the
words ‘‘approved individual’’.
■ c. In paragraph (g), by removing the
word ‘‘Internet’’ and adding the words
‘‘National Select Agent Registry’’ in its
place.
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■
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14. Section 121.13 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.
■ e. In newly redesignated paragraph
(c), by removing the words ‘‘paragraph
(b)’’ and adding the words ‘‘paragraph
(a)’’ in their place.
The revision reads as follows:
■
26831
November 14, 2013 (78 FR 68506).
Those rules, 17 CFR Parts 1, 3, 22, 30,
and 140, took effect on January 13, 2014.
This correction amends Appendix B to
17 CFR 1.20 and Appendix B to 17 CFR
1.26 by removing a phrase from both
appendices.
DATES:
Effective on May 12, 2014.
FOR FURTHER INFORMATION CONTACT:
AGENCY:
Parisa Abadi, Attorney-Advisor, 202–
418–6620, pabadi@cftc.gov, Division of
Clearing and Risk, Commodity Futures
Trading Commission, Three Lafayette
Centre, 1155 21st Street NW.,
Washington, DC 20581.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 14, 2013
(78 FR 68506), the Commission
published final rules adopting new
regulations and amending existing
regulations to require enhanced
customer protections, risk management
programs, internal monitoring and
controls, capital and liquidity standards,
customer disclosures, and auditing and
examination programs for futures
commission merchants (‘‘FCMs’’). The
final rules also address certain related
issues concerning derivatives clearing
organizations (‘‘DCOs’’), including the
requirement that a DCO obtain a written
acknowledgment from each depository
or money market mutual fund with
which the DCO holds or invests
customer funds, in the form of a
standard template letter set forth in
Appendix B to 17 CFR 1.20—
Derivatives Clearing Organization
Acknowledgment Letter for CFTC
Regulation 1.20 Customer Segregated
Account, and in Appendix B to 17 CFR
1.26—Derivatives Clearing Organization
Acknowledgment Letter for CFTC
Regulation 1.26 Customer Segregated
Money Market Mutual Fund Account,
respectively (each an ‘‘Acknowledgment
Letter’’).
The sixth full paragraph 1 of the body
of the Acknowledgment Letter set forth
in Appendix B to 17 CFR 1.20 and the
seventh full paragraph of the body of the
Acknowledgment Letter set forth in
Appendix B to 17 CFR 1.26 address the
depository’s or money market mutual
fund’s obligations in the event of the
bankruptcy of the DCO account holder.
The provisions are intended to relate
exclusively to the bankruptcy of the
account holder and should not
additionally refer to the bankruptcy of
The Commodity Futures
Trading Commission (‘‘Commission’’ or
‘‘CFTC’’) is correcting final rules
published in the Federal Register of
1 This paragraph, as revised, will become the
seventh full paragraph of the body of the
Acknowledgment Letter set forth in Appendix B to
17 CFR 1.20, after the format of that
Acknowledgment Letter is conformed to the format
of the Acknowledgment Letter set forth in
Appendix B to 17 CFR 1.26.
§ 121.13
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 Administrator:
(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.
*
*
*
*
*
Done in Washington, DC, this 1st day of
May 2014.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2014–10741 Filed 5–9–14; 8:45 am]
BILLING CODE 3410–34–P
COMMODITY FUTURES TRADING
COMMISSION
17 CFR Part 1
RIN 3038–AD88
Enhancing Protections Afforded
Customers and Customer Funds Held
by Futures Commission Merchants
and Derivatives Clearing
Organizations; Correction
Commodity Futures Trading
Commission.
ACTION: Correcting amendments.
SUMMARY:
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12MYR1
]]>Agencies
[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Rules and Regulations]
[Pages 26829-26831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10741]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and
Regulations
[[Page 26829]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 331
9 CFR Part 121
[Docket No. APHIS-2009-0070]
Agricultural Bioterrorism Protection Act of 2002; Biennial Review
and Republication of the Select Agent and Toxin List; Amendments to the
Select Agent and Toxin Regulations; Technical Amendment
AGENCY: Animal and Plant Health Inspection Service, USDA.
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 animal or
plant health, or to animal or plant products; 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, plant, or
animal health; and amended the regulations in order to add definitions
and clarify language concerning security, training, biosafety,
biocontainment, and incident response. In that final rule we neglected
to precisely align all of our regulatory language with that used by the
Centers for Disease Control and Prevention (CDC) in their regulations
and, in some cases, did not align our language in the Animal and Plant
Health Inspection Service (APHIS) regulations concerning plant health
and plant products with that concerning animal health and animal
products. As APHIS co-administers the select agent regulations with
CDC, this document corrects inconsistencies in language between APHIS
and CDC 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 agricultural or public health emergencies, and adding language to
specify that individuals not approved for 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: Dr. Charles L. Divan, Unit Director,
APHIS Agriculture Select Agent Services, APHIS, 4700 River Road Unit 2,
Riverdale, MD 20737-1231; (301) 851-3300, option 3.
SUPPLEMENTARY INFORMATION: The Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (referred to below as the
Bioterrorism Response Act) provides for the regulation of certain
biological agents that have the potential to pose a severe threat to
both human and animal health, to animal health, to plant health, or to
animal and plant products. The Animal and Plant Health Inspection
Service (APHIS) has the primary responsibility for implementing the
provisions of the Act within the U.S. Department of Agriculture (USDA).
Veterinary Services (VS) select agents and toxins are those that have
been determined to have the potential to pose a severe threat to animal
health or animal products. Plant Protection and Quarantine (PPQ) select
agents and toxins are those that have the potential to pose a severe
threat to plant health or plant products. Overlap select agents and
toxins are those that have been determined to pose a severe threat to
both human and animal health or animal products. Overlap select agents
are subject to regulation by both APHIS and the Centers for Disease
Control and Prevention (CDC), which has the primary responsibility for
implementing the provisions of the Act for the Department of Health and
Human Services (HHS).
We use the term ``select agents and toxins'' throughout the
preamble of this technical amendment. Unless otherwise specified, the
term ``select agents and toxins'' will refer to all agents or toxins
listed by APHIS. When it is necessary to specify the type of select
agent or toxin, we will use the following terms: ``PPQ select agents
and toxins'' (for the plant agents and toxins listed in 7 CFR 331.3),
``VS select agents and toxins'' (for the animal agents and toxins
listed in 9 CFR 121.3), or ``overlap select agents and toxins'' (for
the agents and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).
On October 5, 2012, we published in the Federal Register (77 FR
61056-61081, Docket No. APHIS-2009-0070) a final rule \1\ that amended
and republished the list of select agents and toxins that have the
potential to pose a severe threat to animal or plant health, or to
animal or plant products; 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, plant, or animal health; and
amended the regulations in order to add definitions and clarify
language concerning security, training, biosafety, biocontainment, and
incident response. Concurrently, CDC published a final rule amending
and republishing the list of select agents that have the potential to
pose a severe threat to human health.
---------------------------------------------------------------------------
\1\ To view the final rule, its preceding proposed rule, and the
comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2009-0070.
---------------------------------------------------------------------------
APHIS and CDC worked to establish identical language in their
respective regulations wherever possible. Within APHIS, we also aimed
to maintain consistency between the VS and PPQ select agent
regulations. The current action is necessary to correct the
discrepancies in language in order to fully harmonize the regulations.
We are also clarifying a term used in the PPQ select agents and
toxins regulations in Sec. 331.3(d)(3) and the VS and overlap select
agents and toxins regulations in Sec. Sec. 121.3(d)(3) and
121.4(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 do not
[[Page 26830]]
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
both human and animal health, to animal health, to plant health, or to
animal and plant products. These sections allow the listed virus
strains and agent subspecies to be excluded from the requirements of
the regulations provided that an entity can verify that the virus or
agent in their possession is within the listed strain or subspecies. In
this amendment, we are replacing the word ``verify'' with the word
``identify,'' as identification must occur prior to verification of a
viral strain or subspecies of agent.
Sections 331.3(e), 121.3(e), and 121.4(e) concern the circumstances
under which attenuated strains of select agents or inactive 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 in order to cover a broader category of
toxins. 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. By comparison, an inactive select toxin is completely non-
functional. A written request and supporting scientific information
would have to be submitted for toxins that have been modified to be
less toxic or potent and a determination of whether to exclude the
submitted toxin would be made by the Administrator.
Paragraphs 121.6(e) and (f) involve temporary exemptions to all or
part of the regulations concerning overlap select agents and toxins,
which may be granted by the Administrator or requested by the HHS
Secretary in the event of an agricultural or public health emergency.
We are amending the language in order to clarify that entities do not
have to request these exemptions, as is the case with the other
potential exemptions listed in Sec. 121.6, since the decision
regarding whether to issue exemptions is predicated on an independent
determination of the existence of such an emergency by the
Administrator or HHS Secretary.
Finally, Sec. 331.11(d)(2) and Sec. 121.11(d)(2) require that
individuals not approved by the Administrator or the HHS Secretary for
access to registered space for activities not related to select agents
or toxins (e.g., routine cleaning, maintenance, and repairs) be
continuously escorted by an approved individual. We are adding language
to clarify that continuous escort is required only if those non-
approved persons could potentially gain access to select agents or
toxins.
List of Subjects
7 CFR Part 331
Agricultural research, Laboratories, Plant diseases and pests,
Reporting and recordkeeping requirements.
9 CFR Part 121
Agricultural research, Animal diseases, Laboratories, Medical
research, Reporting and recordkeeping requirements.
Accordingly, we are amending 7 CFR part 331 and 9 CFR part 121 as
follows:
TITLE 7--AGRICULTURE
PART 331-- POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND
TOXINS
0
1. The authority citation for part 331 continues to read as follows:
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.3.
Sec. 331.1 [Amended]
0
2. Section 331.1 is amended as follows:
0
a. In paragraph (1) of the definition of recombinant nucleic acids, by
removing the words ``(i.e., recombinant nucleic acids)''.
0
b. In the definition of security barrier, by removing the words ``,
animals, or materials''.
0
3. Section 331.3 is amended as follows:
0
a. In paragraph (d)(3), by removing the word ``verify'' and adding the
word ``identify'' in its place.
0
b. By revising paragraph (e) introductory text.
0
c. In paragraph (e)(2), by removing the word ``inactivated'' and adding
the word ``modified'' in its place.
The revision reads as follows:
Sec. 331.3 PPQ 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
Administrator that the attenuated strain or modified toxin does not
pose a severe threat to plant health or plant products.
* * * * *
Sec. 331.11 [Amended]
0
4. Section 331.11 is amended as follows:
0
a. In paragraph (d)(2), by adding the words ``if the potential to
access to select agents or toxins exists'' after the words ``approved
individual''.
0
b. In paragraph (g), by removing the word ``documents'' and adding the
word ``document'' in its place.
Sec. 331.12 [Amended]
0
5. In Sec. 331.12, paragraph (a) is amended by adding the words
``(including arthropods)'' after the words ``including any animals''.
Sec. 331.13 [Amended]
0
6. In Sec. 331.13, paragraph (a) introductory text is amended by
removing both commas.
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS
0
7. The authority citation for part 121 continues to read as follows:
Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.
0
8. Section 121.3 is amended as follows:
0
a. In paragraph (d)(3), by removing the word ``verify'' and adding the
word ``identify'' in its place.
0
b. By revising paragraph (e) introductory text.
0
c. In paragraph (e)(2), by removing the word ``inactivated'' and adding
the word ``modified'' in its place.
The revision reads as follows:
Sec. 121.3 VS 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
Administrator that the attenuated strain or modified toxin does not
pose a severe threat to animal health or animal products.
* * * * *
0
9. Section 121.4 is amended as follows:
0
a. In paragraph (d)(3), by removing the word ``verify'' and adding the
word ``identify'' in its place.
0
b. By revising paragraph (e) introductory text.
0
c. In paragraph (e)(2) by removing the word ``inactivated'' and adding
the word ``modified'' in its place.
0
d. In paragraph (f)(3)(i), first sentence, by removing the second
occurrence of the word ``and'' and adding the word ``or'' in its place.
The revision reads as follows:
Sec. 121.4 Overlap select agents and toxins.
* * * * *
(e) An attenuated strain of a select agent or a select toxin
modified to be
[[Page 26831]]
less potent or toxic may be excluded from the requirements of this part
based upon a determination by the Administrator that the attenuated
strain or modified toxin does not pose a severe threat to public health
and safety, animal health, or animal products.
* * * * *
Sec. 121.5 [Amended]
0
10. In Sec. 121.5, paragraph (a)(3)(i) is amended by removing the
words ``and swine'' and adding the words ``or swine'' in their place.
0
11. Section 121.6 is amended as follows:
0
a. In paragraph (a)(3)(i), by removing the second occurrence of the
word ``and'' and adding the word ``or'' in its place.
0
b. By revising paragraphs (e) and (f).
The revisions read as follows:
Sec. 121.6 Exemptions for overlap select agents and toxins.
* * * * *
(e) If it is necessary to respond to a domestic or foreign
agricultural emergency involving an overlap select agent or toxin, the
Administrator may exempt an individual or entity from the requirements,
in whole or in part, of this part for up to 30 calendar days. The
Administrator may extend the exemption once for an additional 30 days.
(f) Upon request of the Secretary of Health and Human Services, the
Administrator may exempt an individual or entity from the requirements,
in whole or in part, of this part for up to 30 calendar days if the
Secretary of Health and Human Services has granted an exemption for a
public health emergency involving an overlap select agent or toxin. The
Administrator may extend the exemption once for an additional 30 days.
Sec. 121.9 [Amended]
0
12. In Sec. 121.9, paragraph (c)(1) is amended by removing the words
``and swine'' and adding the words ``or swine'' in their place.
Sec. 121.11 [Amended]
0
13. Section 121.11 is amended as follows:
0
a. In paragraph (c)(2), by adding the words ``(including arthropods)''
after the word ``animals''.
0
b. In paragraph (d)(2), by adding the words ``if the potential to
access to select agents or toxins exists'' after the words ``approved
individual''.
0
c. In paragraph (g), by removing the word ``Internet'' and adding the
words ``National Select Agent Registry'' in its place.
0
14. Section 121.13 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.
0
e. In newly redesignated paragraph (c), by removing the words
``paragraph (b)'' and adding the words ``paragraph (a)'' in their
place.
The revision reads as follows:
Sec. 121.13 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
Administrator:
(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.
* * * * *
Done in Washington, DC, this 1st day of May 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-10741 Filed 5-9-14; 8:45 am]
BILLING CODE 3410-34-P
