83 FR 48201 - 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

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 185 (September 24, 2018)

As part of a final rule 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. In that final rule we removed bovine spongiform encephalopathy agent from the list of select agents or toxins, but we neglected to remove it from the list of those select agents or toxins whose seizure must be reported within 24 hours by telephone, facsimile, or email. We are remedying that oversight in this document. We are also updating the name of another select agent to reflect its most current scientific classification, correcting a typographical error, and updating the name of a guidance document referenced in the regulations.

[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Rules and Regulations]
[Pages 48201-48202]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20694]



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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. 

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Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / 
Rules and Regulations

[[Page 48201]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 331

9 CFR Part 121

[Docket No. APHIS-2009-0070]
RIN 0579-AD09


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: As part of a final rule 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. In that final rule we 
removed bovine spongiform encephalopathy agent from the list of select 
agents or toxins, but we neglected to remove it from the list of those 
select agents or toxins whose seizure must be reported within 24 hours 
by telephone, facsimile, or email. We are remedying that oversight in 
this document. We are also updating the name of another select agent to 
reflect its most current scientific classification, correcting a 
typographical error, and updating the name of a guidance document 
referenced in the regulations.

DATES: Effective September 24, 2018.

FOR FURTHER INFORMATION CONTACT: Dr. Keith Wiggins, Acting National 
Director, Agriculture Select Agent Services, APHIS, 4700 River Road 
Unit 2, Riverdale, MD 20737-1231; (301) 851-2024.

SUPPLEMENTARY INFORMATION: 

Background

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 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. 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, which has the primary responsibility for implementing the 
provisions of the Act for the Department of Health and Human Services.
    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; and amended the regulations in order to add 
definitions and clarify language concerning security, training, 
biosafety, biocontainment, and incident response.
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    \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.
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    In that rule, we removed bovine spongiform encephalopathy agent 
from the list of VS select agents and toxins set out in 9 
CFR[thinsp]121.3(b). However, paragraph (f)(3)(i) of that section 
continues to list bovine spongiform encephalopathy agent among those VS 
select agents and toxins whose seizure by any Federal law enforcement 
agency must be reported within 24 hours by telephone, facsimile, or 
email. We are removing this outdated reference. Additionally, in 
paragraph (d)(9) of that section we reference pigeon paramyxovirus-1, 
but the numerical suffix appears as ``-12'' instead of ``-1.'' We are 
correcting that.
    The list of PPQ select agents and toxins is set out in 7 CFR 
331.3(b) and includes the fungal plant pathogen, Phoma glycinicola 
(formerly Pyrenochaeta glycines). Recent molecular and phylogenetic 
studies have resulted in the reclassification of this pathogen as 
Coniothyrium glycines.\2\ We are updating the regulations accordingly.
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    \2\ de Gruyter J, Woudenberg JHC, Aveskamp MM, et al. (2013). 
Redisposition of phoma-like anamorphs in Pleosporales re-evaluation. 
Studies in Mycology 75: 1-36. https://www.sciencedirect.com/science/article/pii/S0166061614600014?via%3Dihub.
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    The regulations in 7 CFR 331.11 and 9 CFR 121.11 require 
development of a security plan that provides for measures sufficient to 
safeguard the select agent or toxin against unauthorized access, theft, 
loss, or release. In paragraph (g) of those sections, we recommend that 
an individual or entity consider the document entitled, ``Security 
Guidance for Select Agent or Toxin Facilities'' when developing the 
required plan.
    We are correcting the name of that document, which has been 
shortened to ``Security Plan Guidance,'' in its most recent update.

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, 7 CFR part 331 and 9 CFR part 121 are amended 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.  331.3   [Amended]

0
2. In Sec.  331.3, paragraph (b) is amended by removing the entry 
``Phoma

[[Page 48202]]

glycinicola (formerly Pyrenochaeta glycines);'' and adding, in 
alphabetical order, an entry for ``Coniothyrium glycines, (formerly 
Phoma glycinicola, Pyrenochaeta glycines);''.


Sec.  331.11   [Amended]

0
3. In Sec.  331.11, paragraph (g) is amended by removing the words 
``Security Guidance for Select Agent or Toxin Facilities'' and adding 
the words ``Security Plan Guidance'' in their place.

Title 9--Animals and Animal Products

PART 121--POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS

0
3. 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.


Sec.  121.3   [Amended]

0
4. Section 121.3 is amended as follows:
0
a. In paragraph (d)(9), by removing ``-12'' and adding ``-1'' in their 
place; and
0
b. In paragraph (f)(3)(i), by removing the words ``bovine spongiform 
encephalopathy agent,''.


Sec.  121.11   [Amended]

0
5. In Sec.  121.11, paragraph (g) is amended by removing the words 
``Security Guidance for Select Agent or Toxin Facilities'' and adding 
the words ``Security Plan Guidance'' in their place.

    Done in Washington, DC, this 19th day of September 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-20694 Filed 9-21-18; 8:45 am]
 BILLING CODE 3410-34-P