49244 Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Proposed Rules 

severed from the remainder of the rule, 

EPA may adopt as final those provisions 

of the rule that are not the subject of an 

adverse comment. 

For additional information, see the 

direct final rule which is located in the 

rules section of this Federal Register. 

Dated: August 16, 2007. 

Richard E. Greene, 

Regional Administrator, Region 6. 

[FR Doc. E7–16830 Filed 8–27–07; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 73 

Possession, Use, and Transfer of 

Select Agents and Toxins 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The select agents and toxins 

listed in 42 CFR part 73 include those 

regulated only by the U.S. Department 

of Health and Human Services (HHS) 

(42 CFR 73.3), as well as those overlap 

select agents and toxins regulated by 

both HHS and the U.S. Department of 

Agriculture (USDA) (42 CFR 73.4). In 

response to USDA’s proposal to no 

longer regulate ten select agents and 

toxins currently listed as ‘‘overlap’’

agents and toxins, we are proposing to 

move those ten select agents and toxins 

from the overlap select agents and 

toxins section to the HHS select agents 

and toxins section. 

DATES: Written comments must be 

received on or before October 29, 2007. 

Comments received after October 29, 

2007 will be considered to the extent 

practicable. 

ADDRESSES: Comments on the changes 

to the list of select agents and toxins 

should be marked ‘‘Comments on the 

changes to the list of select agents and 

toxins’’ and mailed to: Centers for 

Disease Control and Prevention, 

Division of Select Agents and Toxins, 

1600 Clifton Road, MS A–46, Atlanta, 

GA 30333. Comments may be e-mailed 

to: SAPcomments@cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Robbin Weyant, Director, Division of 

Select Agents and Toxins, Centers for 

Disease Control and Prevention, 1600 

Clifton Rd., MS A–46, Atlanta, GA 

30333. Telephone: (404) 718–2000. 

SUPPLEMENTARY INFORMATION: The Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002, 

Subtitle A of Public Law 107–188 (42 

U.S.C. 262a) (the Bioterrorism 

Preparedness Act), required the HHS 

Secretary to establish by regulation a list 

of each biological agent and each toxin 

that has the potential to pose a severe 

threat to public health and safety. In 

determining whether to include an 

agent or toxin on the list, the HHS 

Secretary considered the effect on 

human health of exposure to an agent or 

toxin; the degree of contagiousness of 

the agent or toxin and the methods by 

which the agent or toxin is transferred 

to humans; the availability and 

effectiveness of pharmacotherapies and 

immunizations to treat and prevent 

illnesses resulting from an agent or 

toxin; the potential for an agent or toxin 

to be used as a biological weapon; and 

the needs of children and other 

vulnerable populations. Once 

established, the Bioterrorism 

Preparedness Act requires that the HHS 

Secretary review and republish the list 

of select agents and toxins on at least a 

biennial basis. 

The HHS Secretary promulgated the 

current select agents and toxins list in 

a final rule amending Part 73 of title 42 

of the Code of Federal Regulations, 

published on March 18, 2005, and made 

effective on April 18, 2005. The select 

agents and toxins list found in Part 73 

is divided into two sections. The select 

agents and toxins listed in section 73.3 

(HHS select agents and toxins) are those 

select agents and toxins regulated only 

by HHS. The select agents and toxins 

listed in section 73.4 (Overlap select 

agents and toxins) are those select 

agents and toxins regulated by HHS and 

USDA under the provisions of the 

Agricultural Bioterrorism Protection Act 

of 2002. 

The Agricultural Bioterrorism 

Protection Act of 2002, Subtitle B of 

Public Law 107–188 (7 U.S.C. 8401) (the 

Agricultural Bioterrorism Protection 

Act), requires the USDA Secretary to 

establish by regulation a list of each 

biological agent and each toxin that the 

Secretary determines has the potential 

to pose a severe threat to animal or plant 

health or animal or plant products. In 

determining whether to include an 

agent or toxin on the list, the USDA 

Secretary considered the effect of 

exposure to the agent or toxin on animal 

or plant health, and on the production 

and marketability of animal or plant 

products; the pathogenicity of the agent 

or the toxicity of the toxin and the 

methods by which the agent or toxin is 

transferred to animals and plants; the 

availability and effectiveness of 

pharmacotherapies and prophylaxis to 

treat and prevent any illness caused by 

the agent or toxin; and the potential of 

an agent or toxin for use as a biological 

weapon. The USDA Secretary is also 

required to conduct a biennial review of 

the USDA select agents and toxins list. 

HHS completed its biennial review on 

February 22, 2007 and determined that 

it would neither add nor remove any 

agents or toxins from its select agents 

and toxins list. To assist with the 

biennial review, HHS reviewed 

recommendations provided by subject 

matter experts and the 

Intragovernmental Select Agents and 

Toxins Advisory Committee (ISATTAC). 

The ISATTAC is comprised of Federal 

government employees from the CDC, 

the National Institutes of Health (NIH), 

the Food and Drug Administration 

(FDA), the USDA/Animal and Plant 

Health Inspection Service (APHIS), 

USDA/Agricultural Research Service 

(ARS), USDA/CVB (Center for 

Veterinary Biologics) and the 

Department of Defense (DOD). 

After conducting its biennial review, 

USDA has proposed that it will no 

longer regulate ten of the select agents 

and toxins currently listed as ‘‘overlap’’

select agents and toxins in section 73.4. 

If their decision becomes final, HHS 

will move those ten select agents and 

toxins from section 73.4 to section 73.3. 

Published in today’s Federal Register is 

USDA’s proposal to remove from Part 

121 of Title 9 of the Code of Federal 

Regulations the following agents and 

toxins: Botulinum neurotoxins; 

Botulinum neurotoxin producing 

species of Clostridium, Coxiella 

burnetti, Francisella tularensis, 

Coccidioides immitis, Eastern equine 

encephalitis virus, T–2 toxin, 

Staphylococcal enterotoxins, 

Shigatoxin, and Clostridium perfringens 

epsilon toxin. Comments regarding 

USDA’s proposal to no longer regulate 

ten select agents and toxins currently 

listed as ‘‘overlap’’ agents and toxins 

should be sent to USDA. 

Regulatory Analyses 

Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)), requires that the 

HHS consider the impact of paperwork 

and other information collection 

burdens imposed on the public. We 

have determined no new information 

collection requirements are associated 

with this proposed rule. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This action has been determined not 

significant for purposes of Executive 

Order 12866, and therefore, has not 

been reviewed by the Office of 

Management and Budget. The 

Regulatory Flexibility Act (5 U.S.C. 601 


rwilkins on PROD1PC63 with PROPOSALS-1
Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Proposed Rules 49245 

et seq.) requires an agency to review 

regulations to assess their impact on 

small entities unless the agency 

determines that a rule is not expected to 

have a significant impact on a 

substantial number of small entities. 

This rule will have no costs because it 

merely changes the designation of ten 

select agents and toxins from being 

regulated by both HHS and USDA to 

being regulated solely by HHS. We 

hereby certify this proposed rule will 

not have a significant economic impact 

on a substantial number of small 

businesses. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

at 2 U.S.C. 1532 requires that agencies 

prepare an assessment of anticipated 

costs and benefits before developing any 

rule that may result in expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector of 

$100 million or more (adjusted for 

inflation) in any given year. This 

proposed rule is not expected to result 

in any one-year expenditure that would 

exceed this amount. 

Executive Order 12988 

This Notice of Proposed Rulemaking 

has been reviewed under Executive 

Order 12988, Civil Justice Reform. This 

rule: (1) Would preempt all State and 

local laws and regulations that are 

inconsistent with this rule; (2) would 

have no retroactive effect; and (3) would 

not require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Executive Order 13132 

This Notice of Proposed Rulemaking 

has been reviewed under Executive 

Order 13132, Federalism. The notice 

does not propose any regulation that 

would preempt State, local, and Indian 

tribe requirements, or that would have 

any substantial direct effects on the 

States, on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. 

List of Subjects in 42 CFR Part 73 

Biologics, Incorporation by reference, 

Packaging and containers, Penalties, 

Reporting and Recordkeeping 

requirements, Transportation. 

Dated: August 17, 2007. 

Michael O. Leavitt, 

Secretary. 

For the reasons stated in the 

preamble, we are proposing to amend 42 

CFR part 73 as follows: 

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 No. 

107–188, 116 Stat. 637 (42 U.S.C. 262a). 

2. Amend paragraph (b) of § 73.3 by 

adding the following entries in 

alphabetical order and revising the entry 

for Coccidioides posadasii to read as 

follows: 

§ 73.3 HHS select agents and toxins. 

* * * * * 

(b) * * * 

Botulinum neurotoxins 

Botulinum neurotoxin producing 

species of Clostridium 

* * * * * 

Clostridium perfringens epsilon toxin 

Coccidioides posadasii/Coccidioides 

immitis 

* * * * * 

Coxiella burnetii 

* * * * * 

Eastern Equine Encephalitis virus 

* * * * * 

Francisella tularensis 

* * * * * 

Shigatoxin 

* * * * * 

Staphylococcal enterotoxins 

T–2 toxin 

* * * * * 

3. Amend paragraph (d)(3) of § 73.3 by 

adding the following entries in 

alphabetical order: 05. mg of Botulinum 

neurotoxins; 100 mg of Clostridium 

perfringens epsilon toxin; 100 mg of 

Shigatoxin; 5 mg of Staphylococcal 

enterotoxins; or 1,000 mg of T–2 toxin. 

4. Amend paragraph (f)(3)(i) of § 73.3 

by adding the following entries in 

alphabetical order: Botulinum 

neurotoxins and Francisella tularensis. 

§ 73.5 [Amended] 

5. Amend paragraph (a)(3)(i) of § 73.5 

by adding the following entries in 

alphabetical order: Botulinum 

neurotoxins and Francisella tularensis. 

§ 73.4 [Amended] 

6. Amend paragraph (b) of § 73.4 by 

removing the entries for Botulinum 

neurotoxins, Botulinum neurotoxin 

producing species of Clostridium, 

Clostridium perfringens epsilon toxin, 

Coccidioides immitis, Coxiella burnetii, 

Eastern Equine Encephalitis virus, 

Francisella tularensis, Shigatoxin, 

Staphylococcal enterotoxins, and T–2 

toxin. 

7. Remove paragraph (d)(3) of § 73.4. 

8. Amend paragraph (f)(3)(i) of § 73.4 

by removing the following entries: 

Botulinum neurotoxins and Francisella 

tularensis. 

§ 73.6 [Amended] 

9. Amend paragraph (a)(3)(i) of § 73.6 

by removing the following entries: 

Botulinum neurotoxins and Francisella 

tularensis. 

[FR Doc. 07–4233 Filed 8–27–07; 8:45 am] 

BILLING CODE 4163–18–M 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

Endangered and Threatened Wildlife 

and Plants; 12-Month Finding on a 

Petition To List the Gunnison’s Prairie 

Dog as Threatened or Endangered 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice; initiation of status 

review and request for new information. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), announce the 

opening of a public comment period 

regarding the status of the Gunnison’s 

prairie dog (Cynomys gunnisoni) in the 

contiguous United States. We are 

initiating this status review under a July 

2, 2007, court-approved settlement 

agreement, in which we agreed to 

prepare a 12-month finding on a 

petition to list the species as threatened 

or endangered under the Endangered 

Species Act of 1973, as amended (Act). 

Through this action, we encourage all 

interested parties to provide us 

information regarding the status of, and 

any potential threats to, the Gunnison’s 

prairie dog. 

DATES: To be considered in the 12- 

month finding, comments must be 

received on or before October 29, 2007. 

However, we will accept new scientific 

and commercial information on the 

Gunnison’s prairie dog after the official 

comment period closes. 

ADDRESSES: If you wish to provide new 

information, you may submit your 

comments and materials by any one of 

the following methods: 

(1) You may mail or hand-deliver 

written comments and information to 

Gunnison’s Prairie Dog Comments, U.S. 

Fish and Wildlife Service, 764 Horizon 

Drive, Building B, Grand Junction, 

Colorado 81506–3946. 

(2) You may electronic mail (e-mail) 

your comments to 

FW6_Gunnison’s_prairie_dog@fws.gov. 

For directions on how to submit 

comments by e-mail, see the ‘‘Public 


rwilkins on PROD1PC63 with PROPOSALS-1