26860 Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations 

signs) a joint resolution of disapproval, 

described under section 802. 

Another statutory provision that may 

affect this rule is CERCLA section 305, 

which provides for a legislative veto of 

regulations promulgated under 

CERCLA. Although INS v. Chadha, 462 

U.S. 919,103 S. Ct. 2764 (1983), and Bd. 

of Regents of the University of 

Washington v. EPA, 86 F.3d 1214,1222 

(D.C. Cir. 1996), cast the validity of the 

legislative veto into question, the EPA 

has transmitted a copy of this regulation 

to the Secretary of the Senate and the 

Clerk of the House of Representatives. 

If action by Congress under either the 

CRA or CERCLA section 305 calls the 

effective date of this regulation into 

question, the EPA will publish a 

document of clarification in the Federal 

Register. 

List of Subjects in 40 CFR Part 300 

Environmental protection, Air 

pollution control, Chemicals, Hazardous 

substances, Hazardous waste, 

Intergovernmental relations, Natural 

resources, Oil pollution, Penalties, 

Reporting and recordkeeping 

requirements, Superfund, Water 

pollution control, Water supply. 

Dated: May 1, 2014. 

Barry Breen, 

Principal Deputy Assistant Administrator, 

Office of Solid Waste and Emergency 

Response. 

For the reasons set out in this 

preamble, 40 CFR part 300 is amended 

as follows: 

PART 300—NATIONAL OIL AND 

HAZARDOUS SUBSTANCES 

POLLUTION CONTINGENCY PLAN 

■ 1. The authority citation for Part 300 

continues to read as follows: 

Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 

9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, 

1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 

3 CFR, 1987 Comp., p. 193. 

Appendix B to Part 300—[Amended] 

■ 2. Table 1 of Appendix B to Part 300 

by adding entries for ‘‘MacMillan Ring 

Free Oil’’, ‘‘Keddy Mill’’, ‘‘PCE 

Southeast Contamination’’, ‘‘PCE/TCE 

Northeast Contamination’’, ‘‘Unimatic 

Manufacturing Corporation’’, ‘‘WolffAlport Chemical Company’’, and 

‘‘Walker Machine Products, Inc.’’ in 

alphabetical order by state. 

The additions read as follows: 

Appendix B to Part 300—National 

Priorities List 

TABLE 1—GENERAL SUPERFUND SECTION

State Site name City/County Notes a

*******

AR ....................... MacMillan Ring Free Oil .......................................................................... Norphlet.

* * * * * * * 

ME ...................... Keddy Mill ................................................................................................ Windham.

* * * * * * * 

NE ....................... PCE Southeast Contamination ............................................................... York.

NE ....................... PCE/TCE Northeast Contamination ........................................................ York.

* * * * * * * 

NJ ....................... Unimatic Manufacturing Corporation ....................................................... Fairfield.

* * * * * * * 

NY ....................... Wolff-Alport Chemical Company ............................................................. Ridgewood.

* * * * * * * 

TN ....................... Walker Machine Products, Inc. ............................................................... Collierville.

* * * * * * * 

a = Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS score need not be greater 

than or equal to 28.50). 

* * * * * 

[FR Doc. 2014–10831 Filed 5–9–14; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 


emcdonald on DSK67QTVN1PROD with RULES
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations 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 § 73.3(d)(5) and 

§ 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 

§ 73.3(e), § 73.3(e)(2), and § 73.4(e), 

§ 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 § 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, § 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 

■ 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). 

■ 2. In § 73.3: 

■ a. Paragraph (d)(5) is amended by 

removing the word ‘‘verify’’ and adding 

the word ‘‘identify’’ in its place. 

■ b. Paragraph (e) introductory text is 

revised. 

■ c. Paragraph (e)(2) is amended by 

removing the word ‘‘inactivated’’ and 

adding the word ‘‘modified’’ in its 

place. 

The revision reads as follows: 

§ 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. 

* * * * * 

■ 3. In § 73.4: 

■ a. Paragraph (d)(3) is amended by 

removing the word ‘‘verify’’ and adding 

the word ‘‘identify’’ in its place. 

■ b. Paragraph (e) introductory text is 

revised. 

■ c. Paragraph (e)(2) is amended by 

removing the word ‘‘inactivated’’ and 

adding the word ‘‘modified’’ in its 

place. 

■ d. Paragraph (f)(3)(i) is amended by 

adding the word ‘‘overlap’’ before 

‘‘select agent or toxin.’’ 

The revision reads as follows: 


emcdonald on DSK67QTVN1PROD with RULES
26862 Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Rules and Regulations 

§ 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. 

* * * * * 

■ 4. In § 73.6, revise paragraphs (e) and 

(f) to read as follows: 

§ 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. 

■ 5. Section 73.11 is amended as 

follows: 

■ 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.’’ 

■ b. Revise paragraph (c)(9)(iii). 

■ c. In paragraph (d)(2) by adding ‘‘if the 

potential for access to select agents or 

toxins exists’’ after ‘‘approved 

individual.’’ 

■ d. Revise paragraph (f)(4)(viii)(A). 

■ e. Revise paragraph (g). 

The revisions read as follows: 

§ 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 

§ 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/. 

* * * * * 

■ 6. Section 73.13 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. 

The additions read as follows: 

§ 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.’’ 

* * * * * 

§ 73.16 [Amended] 

■ 7. In § 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 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 1 

[WT Docket No. 03–128; FCC 04–222] 

The Nationwide Programmatic 

Agreement Regarding Section 106 

National Historic Preservation Act 

Review Process, Advisory Council on 

Historic Preservation 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, until October 31, 2014, an 

emergency information collection 

associated with the Nationwide 

Programmatic Agreement Regarding the 

Section 106 National Historic 

Preservation Act Review Process. With 

this document, the Commission is 

announcing OMB approval and the 

effective date of the revised 

requirements. 

DATES: FCC Forms 620, 621 and the 

Tower Construction Notification System 

were approved by OMB on April 9, 2014 

and are effective on May 16, 2014. 

FOR FURTHER INFORMATION CONTACT: For 

additional information contact Cathy 

Williams, Cathy.Williams@fcc.gov 

<mailto:Cathy.Williams@fcc.gov>, (202) 

418–2918. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on April 9, 

2014, OMB approved the revised 

information collection requirements for 

Nationwide Programmatic Agreement 

Regarding the Section 106 National 

Historic Preservation Act Review 

Process published at 70 FR 556, January 

4, 2005. The OMB Control Number is 

3060–1039. The Commission publishes 

this notice as an announcement of the 

effective date of the requirements. If you 

have any comments on the burden 

estimates listed below, or how the 

Commission can improve the 

collections and reduce any burdens 

caused thereby, please contact Cathy 

Williams, Federal Communications 

Commission, Room 1–C823, 445 12th 

Street SW., Washington, DC 20554. 

Please include the OMB Control 

Number, 3060–1039, in your 

correspondence. The Commission will 

also accept your comments via the 

Internet if you send them to PRA@

fcc.gov <mailto:PRA@fcc.gov>. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 


emcdonald on DSK67QTVN1PROD with RULES