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.

Rules and Regulations Federal Register

26829 

Vol. 79, No. 91 

Monday, May 12, 2014 

1To view the final rule, its preceding proposed 

rule, and the comments we received, go to http:// 

www.regulations.gov/#!docketDetail;D=APHIS2009-0070. 

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 coadministers 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. 

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 


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 

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 

■ 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’’. 

■ b. In paragraph (g), by removing the 

word ‘‘documents’’ and adding the word 

‘‘document’’ in its place. 

§ 331.12 [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 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations 26831 

1This 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. 

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. 

■ 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: 

§ 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 

AGENCY: Commodity Futures Trading 

Commission. 

ACTION: Correcting amendments. 

SUMMARY: The Commodity Futures 

Trading Commission (‘‘Commission’’ or 

‘‘CFTC’’) is correcting final rules 

published in the Federal Register of 

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: 

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 


emcdonald on DSK67QTVN1PROD with RULES