818 

§ 121.4 9 CFR Ch. I (1–1–10 Edition) 

(e) An attenuated strain of a VS select agent or toxin may be excluded 

from the requirements of this part 

based upon a determination that the 

attenuated strain does not pose a severe threat to animal health or to animal products. 

(1) To apply for an exclusion, an individual or entity must submit a written 

request and supporting scientific information. A written decision granting or 

denying the request will be issued. An 

exclusion will be effective upon notification of the applicant. Exclusions will 

be published periodically in the notice 

section of the FEDERAL REGISTER and 

will be listed on the Internet at http:// 

www.aphis.usda.gov/programs/ 

aglselectagent/index.html. 

(2) If an excluded attenuated strain is 

subjected to any manipulation that restores or enhances its virulence, the resulting select agent or toxin will be 

subject to the requirements of this 

part. 

(3) An individual or entity may make 

a written request to the Administrator 

for reconsideration of a decision denying an exclusion application. The written request for reconsideration must 

state the facts and reasoning upon 

which the individual or entity relies to 

show the decision was incorrect. The 

Administrator will grant or deny the 

request for reconsideration as promptly as circumstances allow and will 

state, in writing, the reasons for the 

decision. 

(f) Any VS select agent or toxin 

seized by a Federal law enforcement 

agency will be excluded from the requirements of this part during the period between seizure of the agent or 

toxin and the transfer or destruction of 

such agent or toxin provided that: 

(1) As soon as practicable, the Federal law enforcement agency transfers 

the seized agent or toxin to an entity 

eligible to receive such agent or toxin 

or destroys the agent or toxin by a recognized sterilization or inactivation 

process. 

(2) The Federal law enforcement 

agency safeguards and secures the 

seized agent or toxin against theft, 

loss, or release, and reports any theft, 

loss, or release of such agent or toxin. 

(3) The Federal law enforcement 

agency reports the seizure of the select 

agent or toxin to APHIS or CDC. 

(i) The seizure of any of the following 

VS select agents and toxins must be reported within 24 hours by telephone, 

facsimile, or e-mail: African horse 

sickness virus, African swine fever 

virus, avian influenza virus (highly 

pathogenic), bovine spongiform 

encephalopathy agent, classical swine 

fever virus, foot-and-mouth disease 

virus, Newcastle disease virus 

(velogenic), rinderpest virus, and swine 

vesicular disease virus. This report 

must be followed by submission of 

APHIS/CDC Form 4 within 7 calendar 

days after seizure of the select agent or 

toxin. 

(ii) For all other VS select agents or 

toxins, APHIS/CDC Form 4 must be 

submitted within 7 calendar days after 

seizure of the agent or toxin. 

(iii) A copy of APHIS/CDC Form 4 

must be maintained for 3 years. 

(4) The Federal law enforcement 

agency reports the final disposition of 

the select agent or toxin by submission 

of APHIS/CDC Form 4. A copy of the 

completed form must be maintained 

for 3 years. 

[70 FR 13284, Mar. 18, 2005, as amended at 73 

FR 61331, Oct. 16, 2008] 

§ 121.4 Overlap select agents and toxins. 

(a) Except as provided in paragraphs 

(d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe 

threat to public health and safety, to 

animal health, or to animal products. 

(b) Overlap select agents and toxins: 

Bacillus anthracis; 

Brucella abortus; 

Brucella melitensis; 

Brucella suis; 

Burkholderia mallei; 

Burkholderia pseudomallei; 

Hendra virus; 

Nipah virus; 

Rift Valley fever virus; 

Venezuelan equine encephalitis virus. 

(c) Genetic elements, recombinant 

nucleic acids, and recombinant organisms: 


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Animal and Plant Health Inspection Service, USDA § 121.4 

4The importation and interstate movement of overlap select agents or toxins listed 

in paragraphs (c)(1) through (c)(3) of this section may be subject to the permit requirements under part 122 of this subchapter. 5 However, the importation and interstate 

movement of these nonviable overlap select 

agents may be subject to the permit requirements under part 122 of this subchapter. 

(1) Nucleic acids that can produce infectious forms of any of the overlap select agent viruses listed in paragraph 

(b) of this section. 4

(2) Recombinant nucleic acids that 

encode for the functional forms of any 

overlap toxin listed in paragraph (b) of 

this section if the nucleic acids: 

(i) Can be expressed in vivo or in vitro; 

or 

(ii) Are in a vector or recombinant 

host genome and can be expressed in 

vivo or in vitro. 

(3) Overlap select agents and toxins 

listed in paragraph (b) of this section 

that have been genetically modified. 

(d) Overlap select agents or toxins 

that meet any of the following criteria 

are excluded from the requirements of 

this part: 

(1) Any overlap select agent or toxin 

that is in its naturally occurring environment, provided that the agent or 

toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. 

(2) Nonviable overlap select agents or 

nonfunctional overlap toxins. 5

(e) An attenuated strain of an overlap select agent or toxin may be excluded from the requirements of this 

part based upon a determination that 

the attenuated strain does not pose a 

severe threat to public health and safety, to animal health, or to animal 

products. 

(1) To apply for an exclusion, an individual or entity must submit a written 

request and supporting scientific information. A written decision granting or 

denying the request will be issued. An 

exclusion will be effective upon notification of the applicant. Exclusions will 

be published periodically in the notice 

section of the FEDERAL REGISTER and 

will be listed on the Internet at http:// 

www.aphis.usda.gov/programs/ 

aglselectagent/index.html. 

(2) If an excluded attenuated strain is 

subjected to any manipulation that restores or enhances its virulence, the resulting overlap select agent or toxin 

will be subject to the requirements of 

this part. 

(3) An individual or entity may make 

a written request to the Administrator 

for reconsideration of a decision denying an exclusion application. The written request for reconsideration must 

state the facts and reasoning upon 

which the individual or entity relies to 

show the decision was incorrect. The 

Administrator will grant or deny the 

request for reconsideration as promptly as circumstances allow and will 

state, in writing, the reasons for the 

decision. 

(f) Any overlap select agent or toxin 

seized by a Federal law enforcement 

agency will be excluded from the requirements of this part during the period between seizure of the agent or 

toxin and the transfer or destruction of 

such agent or toxin provided that: 

(1) As soon as practicable, the Federal law enforcement agency transfers 

the seized agent or toxin to an entity 

eligible to receive such agent or toxin 

or destroys the agent or toxin by a recognized sterilization or inactivation 

process. 

(2) The Federal law enforcement 

agency safeguards and secures the 

seized agent or toxin against theft, 

loss, or release, and reports any theft, 

loss, or release of such agent or toxin. 

(3) The Federal law enforcement 

agency reports the seizure of the overlap select agent or toxin to APHIS or 

CDC. 

(i) The seizure of any of the following 

overlap select agents and toxins must 

be reported within 24 hours by telephone, facsimile, or e-mail: Bacillus 

anthracis, Brucella melitensis, Hendra 

virus, Nipah virus, Rift Valley fever 

virus, and Venezuelan equine encephalitis virus. This report must be followed by submission of APHIS/CDC 

Form 4 within 7 calendar days after 

seizure of the overlap select agent or 

toxin. 

(ii) For all other overlap select 

agents or toxins, APHIS/CDC Form 4 

must be submitted within 7 calendar 

days after seizure of the agent or toxin. 

(iii) A copy of APHIS/CDC Form 4 

must be maintained for 3 years. 


cprice-sewell on DSK89S0YB1PROD with CFR
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§ 121.5 9 CFR Ch. I (1–1–10 Edition) 

(4) The Federal law enforcement 

agency reports the final disposition of 

the overlap select agent or toxin by 

submission of APHIS/CDC Form 4. A 

copy of the completed form must be 

maintained for 3 years. 

[70 FR 13284, Mar. 18, 2005, as amended at 73 

FR 61331, Oct. 16, 2008] 

§ 121.5 Exemptions for VS select 

agents and toxins. 

(a) Diagnostic laboratories and other 

entities that possess, use, or transfer a 

VS select agent or toxin that is contained in a specimen presented for diagnosis or verification will be exempt 

from the requirements of this part for 

such agent or toxin contained in the 

specimen, provided that: 

(1) Unless directed otherwise by the 

Administrator, within 7 calendar days 

after identification, the agent or toxin 

is transferred in accordance with 

§121.16 or destroyed on-site by a recognized sterilization or inactivation process; 

(2) The agent or toxin is secured 

against theft, loss, or release during 

the period between identification of 

the agent or toxin and transfer or destruction of such agent or toxin, and 

any theft, loss, or release of such agent 

or toxin is reported; and 

(3) The identification of the agent or 

toxin is reported to APHIS or CDC. 

(i) The identification of any of the 

following select agents and toxins must 

be immediately reported by telephone, 

facsimile, or e-mail: African horse 

sickness virus, African swine fever 

virus, avian influenza virus (highly 

pathogenic), bovine spongiform 

encephalopathy agent, classical swine 

fever virus, foot-and-mouth disease 

virus, virulent Newcastle disease virus, 

rinderpest virus, and swine vesicular 

disease virus. This report must be followed by submission of APHIS/CDC 

Form 4 within 7 calendar days after 

identification. 

(ii) For all other VS select agents or 

toxins, APHIS/CDC Form 4 must be 

submitted within 7 calendar days after 

identification. 

(iii) Less stringent reporting may be 

required during agricultural emergencies or outbreaks, or in endemic 

areas. 

(iv) A copy of APHIS/CDC Form 4 

must be maintained for 3 years. 

(b) Diagnostic laboratories and other 

entities that possess, use, or transfer a 

VS select agent or toxin that is contained in a specimen presented for proficiency testing will be exempt from 

the requirements of this part for such 

agent or toxin contained in the specimen, provided that: 

(1) Unless directed otherwise by the 

Administrator, within 90 calendar days 

of receipt, the agent or toxin is transferred in accordance with §121.16 or destroyed on-site by a recognized sterilization or inactivation process; 

(2) The agent or toxin is secured 

against theft, loss, or release during 

the period between identification of 

the agent or toxin and transfer or destruction of such agent or toxin, and 

any theft, loss, or release of such agent 

or toxin is reported; and 

(3) The identification of the agent or 

toxin, and its derivative, is reported to 

APHIS or CDC. To report the identification of a select agent or toxin, 

APHIS/CDC Form 4 must be submitted 

within 90 days of receipt of the agent 

or toxin. A copy of the completed form 

must be maintained for 3 years. 

(c) Diagnostic reagents and vaccines 

that are, bear, or contain VS select 

agents or toxins that are produced at 

USDA diagnostic facilities will be exempt from the requirements of this 

part. 

(d) Unless the Administrator by order 

determines that additional regulation 

is necessary to protect animal health 

or animal products, products that are, 

bear, or contain VS select agents or 

toxins will be exempt from the requirements of this part if the products have 

been cleared, approved, licensed, or 

registered pursuant to: 

(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); 

(2) Section 351 of Public Health Service Act (42 U.S.C. 262); 

(3) The Virus-Serum-Toxin Act (21 

U.S.C. 151–159); or 

(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 

131 et seq.). 

(e) The Administrator may exempt 

from the requirements of this part an 

experimental product that is, bears, or 

contains a VS select agent or toxin if 


cprice-sewell on DSK89S0YB1PROD with CFR