83_FR_48386 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

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)

Page Range48201-48202
FR Document2018-20694

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 Issue 185 (Monday, September 24, 2018) 
[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. 

========================================================================


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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

48201 Rules and Regulations Federal Register Vol. 83, No. 185 Monday, September 24, 2018 This section of the FEDERAL REGISTER Background paramyxovirus-1, but the numerical contains regulatory documents having general suffix appears as ‘‘-12’’ instead of ‘‘-1.’’ The Public Health Security and applicability and legal effect, most of which We are correcting that. are keyed to and codified in the Code of Bioterrorism Preparedness and Response Act of 2002 provides for the The list of PPQ select agents and Federal Regulations, which is published under toxins is set out in 7 CFR 331.3(b) and 50 titles pursuant to 44 U.S.C. 1510. regulation of certain biological agents that have the potential to pose a severe includes the fungal plant pathogen, The Code of Federal Regulations is sold by threat to both human and animal health, Phoma glycinicola (formerly the Superintendent of Documents. to animal health, to plant health, or to Pyrenochaeta glycines). Recent animal and plant products. The Animal molecular and phylogenetic studies and Plant Health Inspection Service have resulted in the reclassification of DEPARTMENT OF AGRICULTURE (APHIS) has the primary responsibility this pathogen as Coniothyrium for implementing the provisions of the glycines.2 We are updating the Animal and Plant Health Inspection regulations accordingly. Service Act within the U.S. Department of Agriculture. Veterinary Services (VS) The regulations in 7 CFR 331.11 and select agents and toxins are those that 9 CFR 121.11 require development of a 7 CFR Part 331 security plan that provides for measures have been determined to have the potential to pose a severe threat to sufficient to safeguard the select agent 9 CFR Part 121 or toxin against unauthorized access, animal health or animal products. Plant [Docket No. APHIS–2009–0070] Protection and Quarantine (PPQ) select theft, loss, or release. In paragraph (g) of agents and toxins are those that have the those sections, we recommend that an RIN 0579–AD09 individual or entity consider the potential to pose a severe threat to plant Agricultural Bioterrorism Protection health or plant products. Overlap select document entitled, ‘‘Security Guidance Act of 2002; Biennial Review and agents and toxins are those that have for Select Agent or Toxin Facilities’’ Republication of the Select Agent and been determined to pose a severe threat when developing the required plan. to both human and animal health or We are correcting the name of that Toxin List; Amendments to the Select animal products. Overlap select agents document, which has been shortened to Agent and Toxin Regulations; are subject to regulation by both APHIS ‘‘Security Plan Guidance,’’ in its most Technical Amendment and the Centers for Disease Control and recent update. AGENCY: Animal and Plant Health Prevention, which has the primary List of Subjects Inspection Service, USDA. responsibility for implementing the ACTION: Final rule; technical provisions of the Act for the Department 7 CFR Part 331 amendment. of Health and Human Services. Agricultural research, Laboratories, On October 5, 2012, we published in Plant diseases and pests, Reporting and SUMMARY: As part of a final rule the Federal Register (77 FR 61056– recordkeeping requirements. published in the Federal Register on 61081, Docket No. APHIS–2009–0070) a October 5, 2012, we amended and final rule 1 that amended and 9 CFR Part 121 republished the list of select agents and republished the list of select agents and Agricultural research, Animal toxins that have the potential to pose a toxins that have the potential to pose a diseases, Laboratories, Medical research, severe threat to animal or plant health, severe threat to animal or plant health, Reporting and recordkeeping or to animal or plant products. In that or to animal or plant products; and requirements. final rule we removed bovine amended the regulations in order to add Accordingly, 7 CFR part 331 and 9 spongiform encephalopathy agent from definitions and clarify language CFR part 121 are amended as follows: the list of select agents or toxins, but we concerning security, training, biosafety, neglected to remove it from the list of biocontainment, and incident response. Title 7—Agriculture those select agents or toxins whose In that rule, we removed bovine seizure must be reported within 24 PART 331—POSSESSION, USE, AND spongiform encephalopathy agent from hours by telephone, facsimile, or email. TRANSFER OF SELECT AGENTS AND the list of VS select agents and toxins set We are remedying that oversight in this TOXINS out in 9 CFR 121.3(b). However, document. We are also updating the paragraph (f)(3)(i) of that section ■ 1. The authority citation for part 331 name of another select agent to reflect continues to list bovine spongiform continues to read as follows: its most current scientific classification, encephalopathy agent among those VS correcting a typographical error, and Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, select agents and toxins whose seizure and 371.3. updating the name of a guidance by any Federal law enforcement agency document referenced in the regulations. must be reported within 24 hours by § 331.3 [Amended] DATES: Effective September 24, 2018. telephone, facsimile, or email. We are ■ 2. In § 331.3, paragraph (b) is amended FOR FURTHER INFORMATION CONTACT: Dr. removing this outdated reference. daltland on DSKBBV9HB2PROD with RULES by removing the entry ‘‘Phoma Keith Wiggins, Acting National Director, Additionally, in paragraph (d)(9) of that Agriculture Select Agent Services, section we reference pigeon 2 de Gruyter J, Woudenberg JHC, Aveskamp MM, APHIS, 4700 River Road Unit 2, et al. (2013). Redisposition of phoma-like 1 To view the final rule, its preceding proposed anamorphs in Pleosporales re-evaluation. Studies in Riverdale, MD 20737–1231; (301) 851– rule, and the comments we received, go to http:// Mycology 75: 1–36. https://www.sciencedirect.com/ 2024. www.regulations.gov/#!docketDetail;D=APHIS- science/article/pii/S0166061614600014?via SUPPLEMENTARY INFORMATION: 2009-0070. %3Dihub. VerDate Sep<11>2014 17:46 Sep 21, 2018 Jkt 244001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\24SER1.SGM 24SER1

48202 Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Rules and Regulations glycinicola (formerly Pyrenochaeta Price-Anderson Act. The NRC must 71 Stat. 576), as amended and codified glycines);’’ and adding, in alphabetical perform this adjustment at least once at 42 U.S.C. 2210. In 2005, Congress order, an entry for ‘‘Coniothyrium during each 5-year period following amended section 170 of the AEA (Pub. glycines, (formerly Phoma glycinicola, August 20, 2003, as mandated by the L. 109–58, 119 Stat. 780) to require the Pyrenochaeta glycines);’’. Atomic Energy Act of 1954, as amended NRC to adjust for inflation the (AEA). maximum total and annual standard § 331.11 [Amended] deferred premiums that may be charged DATES: This rule is effective on ■ 3. In § 331.11, paragraph (g) is November 1, 2018. to a licensee following a nuclear amended by removing the words ADDRESSES: Please refer to Docket ID incident. These adjustments must be ‘‘Security Guidance for Select Agent or NRC–2017–0030 when contacting the performed not less than once during Toxin Facilities’’ and adding the words NRC about the availability of each 5-year period following August 20, ‘‘Security Plan Guidance’’ in their place. information for this action. You may 2003, in accordance with the aggregate obtain publicly-available information percentage change in the Consumer Title 9—Animals and Animal Products Price Index (CPI) (https://www.bls.gov/ related to this action by any of the PART 121—POSSESSION, USE, AND following methods: cpi) for all urban consumers published • Federal Rulemaking Website: Go to by the Secretary of Labor. The NRC TRANSFER OF SELECT AGENTS AND http://www.regulations.gov and search made the first periodic inflation TOXINS for Docket ID NRC–2017–0030. Address adjustment required by this section on ■ 3. The authority citation for part 121 questions about NRC dockets to Carol September 29, 2008 (73 FR 56451). The continues to read as follows: Gallagher; telephone: 301–415–3463; NRC last adjusted this amount in 2013, email: Carol.Gallagher@nrc.gov. For establishing the current maximum total Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, deferred premium at $121,255,000, and and 371.4. technical questions, contact the individual listed in the FOR FURTHER the maximum annual deferred premium § 121.3 [Amended] INFORMATION CONTACT section of this at $18,963,000 (78 FR 41835; July 12, document. 2013). This final rule makes the third ■ 4. Section 121.3 is amended as required periodic inflation adjustment follows: • NRC’s Agencywide Documents Access and Management System and results in a maximum total ■ a. In paragraph (d)(9), by removing ‘‘- (ADAMS): You may obtain publicly- premium of $131,056,000 and an annual 12’’ and adding ‘‘-1’’ in their place; and standard deferred premium of ■ b. In paragraph (f)(3)(i), by removing available documents online in the ADAMS Public Documents collection at $20,496,000. the words ‘‘bovine spongiform encephalopathy agent,’’. http://www.nrc.gov/reading-rm/ II. Discussion adams.html. To begin the search, select Section 170(t) of the AEA (42 U.S.C. § 121.11 [Amended] ‘‘ADAMS Public Documents’’ and then 2210(t)) requires the NRC to ‘‘adjust the ■ 5. In § 121.11, paragraph (g) is select ‘‘Begin Web-based ADAMS amount of the maximum total and amended by removing the words Search.’’ For problems with ADAMS, annual standard deferred premium not ‘‘Security Guidance for Select Agent or please contact the NRC’s Public less than once during each 5-year period Toxin Facilities’’ and adding the words Document Room (PDR) reference staff at following August 20, 2003, in ‘‘Security Plan Guidance’’ in their place. 1–800–397–4209, 301–415–4737, or by accordance with the aggregate email to pdr.resource@nrc.gov. The percentage change in the Consumer Done in Washington, DC, this 19th day of September 2018. ADAMS accession number for each Price Index,’’ since the previous document referenced (if it is available in adjustment. These amounts are codified Kevin Shea, ADAMS) is provided the first time that in § 140.11, ‘‘Amounts of financial Administrator, Animal and Plant Health it is mentioned in the SUPPLEMENTARY protection for certain reactors.’’ Inspection Service. INFORMATION section. Accordingly, the NRC is amending [FR Doc. 2018–20694 Filed 9–21–18; 8:45 am] • NRC’s PDR: You may examine and § 140.11(a)(4) to adjust for the increase BILLING CODE 3410–34–P purchase copies of public documents at in inflation, since the last adjustment to the NRC’s PDR, Room O1–F21, One these amounts was made in 2013. White Flint North, 11555 Rockville The inflation adjustment that the NRC NUCLEAR REGULATORY Pike, Rockville, Maryland 20852. made on July 12, 2013 (78 FR 41835) COMMISSION FOR FURTHER INFORMATION CONTACT: and which took effect on September 10, Yanely Malave-Velez, Office of Nuclear 2013, raised the maximum total deferred 10 CFR Part 140 Material Safety and Safeguards, U.S. premium in § 140.11(a)(4) to [NRC–2017–0030] Nuclear Regulatory Commission, $121,255,000 and the maximum annual Washington DC 20555–0001; telephone: deferred premium to $18,963,000. The RIN 3150–AK01 301–415–1519, email: Yanely.Malave- CPI figure used in calculating this Velez@nrc.gov. adjustment was 232.773 (March 2013). Inflation Adjustments to the Price- SUPPLEMENTARY INFORMATION: The inflation adjustment in this final Anderson Act Financial Protection rule are based on a CPI figure of 251.588 Regulations I. Background (May 2018). This represents an increase AGENCY: Nuclear Regulatory The NRC’s regulations in part 140 of of approximately 8.08 percent. The Commission. title 10 of the Code of Federal adjustment methodology used to Regulations (10 CFR), ‘‘Financial calculate these values is described on daltland on DSKBBV9HB2PROD with RULES ACTION: Final rule. Protection Requirements and Indemnity the Bureau of Labor Statistics’ website SUMMARY: The U.S. Nuclear Regulatory Agreements,’’ implement the financial (https://www.bls.gov). When this Commission (NRC) is amending its protection requirements of certain increase is applied to the maximum regulations to adjust for inflation the licensees and other persons under total and annual standard deferred maximum total and annual standard section 170 of the AEA, also known as premiums and rounded to the nearest deferred premiums specified in the the Price-Anderson Act (Pub. L. 85–256, thousand, the new maximum total VerDate Sep<11>2014 17:46 Sep 21, 2018 Jkt 244001 PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 E:\FR\FM\24SER1.SGM 24SER1


Document Created: 2018-09-22 00:32:39
Document Modified: 2018-09-22 00:32:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment.
DatesEffective September 24, 2018.
ContactDr. Keith Wiggins, Acting National Director, Agriculture Select Agent Services, APHIS, 4700 River Road Unit 2, Riverdale, MD 20737-1231; (301) 851-2024.
FR Citation83 FR 48201 
RIN Number0579-AD09
CFR Citation7 CFR 331
9 CFR 121
CFR AssociatedAgricultural Research; Laboratories; Plant Diseases and Pests; Reporting and Recordkeeping Requirements; Animal Diseases and Medical Research
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