[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Rules and Regulations]
[Pages 26829-26831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10741]



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 Rules and Regulations
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  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.

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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 http://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]
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