[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Rules and Regulations]
[Pages 26860-26862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10740]


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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.

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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 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 http://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