### 818 9 CFR Ch. I (1–1–10 Edition) § 121.4

(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 theattenuated 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 writtenrequest and supporting scientific information. A written decision granting or denying the request will be issued. Anexclusion will be effective upon notification of the applicant. Exclusions will be published periodically in the notice
section of the F EDERAL R EGISTER and
will be listed on the Internet at http:// www.aphis.usda.gov/programs/

ag

l selectagent/index.html.

(2) If an excluded attenuated strain issubjected 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 Administratorfor 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 therequest 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 enforcementagency 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 toxinor 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 followingVS 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, recombinantnucleic acids, and recombinant organisms:


### 819 Animal and Plant Health Inspection Service, USDA § 121.4

4 The importation and interstate movement of overlap select agents or toxins listedin 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 selectagents 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 toxinthat is in its naturally occurring environment, provided that the agent ortoxin 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 asevere 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 writtenrequest and supporting scientific information. A written decision granting or denying the request will be issued. Anexclusion will be effective upon notification of the applicant. Exclusions will be published periodically in the notice
section of the F EDERAL R EGISTER and
will be listed on the Internet at http:// www.aphis.usda.gov/programs/

ag

l selectagent/index.html.

(2) If an excluded attenuated strain issubjected 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 Administratorfor 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 therequest 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 enforcementagency 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 toxinor 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 enforcementagency 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 mustbe reported within 24 hours by telephone, facsimile, or e-mail: Bacillus anthracis, Brucella melitensis, Hendra virus, Nipah virus, Rift Valley fevervirus, 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.


### 820 9 CFR Ch. I (1–1–10 Edition) § 121.5

(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 aVS 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 ofthe 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 vesiculardisease 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 berequired 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 aVS select agent or toxin that is contained in a specimen presented for proficiency testing will be exempt from the requirements of this part for suchagent or toxin contained in the specimen, provided that:

(1) Unless directed otherwise by the Administrator, within 90 calendar daysof 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 ofthe 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 toAPHIS 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 atUSDA 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 ortoxins 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