20 CAR Part 5 — Rules Pertaining to Biological Select Agents and Toxins

Chapter I

Subchapter A

Subpart 1

20 CAR § 5-101 Purpose and scope {#sec-20-car-5-101 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-101}

20 CAR § 5-101. Purpose and scope.

To establish a Biological Agent Registry to identify the biological agents possessed and maintained by any person in the state of Arkansas.

20 CAR § 5-102 Definitions {#sec-20-car-5-102 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-102}

20 CAR § 5-102. Definitions.

As used in this part:

(1) “Biological agent” means any:

(A) Select agent that is a microorganism, virus, bacterium, fungus, rickettsia, or toxin listed in 42 C.F.R. pt. 72, Appendix A [removed], as in effect on January 1, 2003;

(B) Genetically modified microorganisms or genetic elements from an organism on 42 C.F.R. pt. 72, Appendix A [removed], as in effect on January 1, 2003, shown to produce or encode for a factor associated with a disease; or

(C) Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins listed on 42 C.F.R. pt. 72, Appendix A [removed], as in effect on January 1, 2003, or their toxic submits; and

(2) “Person” means any:

(A) Association;

(B) Business;

(C) Corporation;

(D) Facility;

(E) Firm;

(F) Individual;

(G) Institution of higher education;

(H) Organization;

(I) Partnership;

(J) Society;

(K) State agency; or

(L) Other legal entity.

History

• Codification Notes: C.F.R. pt. 72 was removed by 73 FR 3874. Authority: Arkansas Code § 20-36-103

20 CAR § 5-103 Registration {#sec-20-car-5-103 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-103}

20 CAR § 5-103. Registration.

Any person required to register must apply for a certificate of registration as outlined in 42 C.F.R. § 73.7.

20 CAR § 5-104 Responsible official {#sec-20-car-5-104 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-104}

20 CAR § 5-104. Responsible official.

Any person listed under 20 CAR § 5-102(2) must designate an individual to be a responsible official who must be approved by the United States Secretary of Health and Human Services or the Administrator of Health and Human Services, following a security risk assessment by the United States Attorney General outlined in 72 C.F.R. § 73.9.

20 CAR § 5-105 Security, biosafety, and training {#sec-20-car-5-105 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-105}

20 CAR § 5-105. Security, biosafety, and training.

(a) Security.

(1) Any registered person must develop and implement a written security plan outlined in 42 C.F.R. § 73.11.

(2) Any registered person may not provide another person access to a select agent or toxin, unless the access is approved by the United States Secretary of Health and Human Services or Administrator, following a security risk assessment by the United States Attorney General outlined in 42 C.F.R. § 73.10.

(b) Biosafety. Any person required to register under this part must develop and implement a written:

(1) Biosafety plan that is commensurate with the risk of agent or toxin, given its intended use as outlined in 42 C.F.R. § 73.12; and

(2) Incident response plan as outlined in 42 C.F.R. § 73.14.

(c) Training. Any person required to register under this part must provide information and training on biosafety and security outlined in 42 C.F.R. § 73.15.

20 CAR § 5-106 United States Department Health and Human Services (HHS) select, overlap agents, and toxins {#sec-20-car-5-106 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-106}

20 CAR § 5-106. United States Department Health and Human Services (HHS) select, overlap agents, and toxins.

(a) United States Department of Health and Human Services select.

(b) Overlap agents and toxins.

(1) Except for exclusions under paragraphs (d) and (e) in the Federal Register, the United States Secretary of Health and Human Services has determined that the biological agents and toxins listed below have the potential to pose a severe threat to public health and safety.

(2) See rule 73.3 United States Department of Health and Human Services select agent and toxin for further information.

Abrin Cecopithecine herpes virus 1 (Herpes B virus) Coccidioides posadasii Crimean-Congo hemorrhagic Fever virus Diacetoxyscirpenol Ebola Virus Lassa fever viruses Marburg virus Monkey pox virus Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight (8) gene segments Ricin Rickettsia Prowazekii Rickettsia rickettsi Saxitoxin Shiga-like ribosome inactivating proteins South American Hemorrhagic Fever Viruses (Junin, Machupo, Sabia, Flexal, Guanarito) Tetrodotoxin Tick-borne encephalitis complex (flavil) viruses (Central European Tick- borne encephalitis, Far Eastern Tick-borne encephalitis, Russian Spring and Summer encephalitis, Kyasanur Forest disease, Omak hemorrhage Fever) Variola major virus (Smallpox virus) and Vaiola minor virus (Alastrim) Yersinia pestis.

(c) Except for exclusions under paragraph (d) and (e) the Federal Register the secretary has determined that the biological agents and toxins listed below have the potential to pose a severe threat to public health and safety, to animal health, or to animal product.

(d) Overlap select agents and toxins. See Rule 73.4 for further information.

Bacillus anthracis Botulinum neurotoxins Botulinum neurotoxin-producing species of Clostridium Brucella abortus Brucella melitnesis Brucella suis Burkholderia pseudomalleia (formerly Pseudomonas) Burkholderia pseudomallei (formerly Pseudomonas pseudomallei) Clostridium perfringens epsilon toxin Coccidioides immitis Coxiella burnetii Eastern Equine Encephalitis virus Francisella tularensis Hendra virus Nipah Virus Rift Valley fever virus Shigatoxin Staphylococcal enterotoxins T-2 toxin Venezuelan Equine Encephalitis virus.

History

• Codification Notes: 73.3 can be found at 42 C.F.R. § 73.3.Rule 73.4 can be found at 42 C.F.R. § 73.4. Authority: Arkansas Code § 20-36-103

20 CAR § 5-107 Exemptions {#sec-20-car-5-107 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-107}

20 CAR § 5-107. Exemptions.

The regulations listed in 42 C.F.R. § 73 and 9 C.F.R. § 121 establish a procedure by which attenuated strains of select biological agents or toxins that do not pose a severe threat to public health and safety, animal health, or animal products may be excluded from the list of select biological agents and toxins.

20 CAR § 5-108 Denial, revocation, or suspension of registration {#sec-20-car-5-108 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-108}

20 CAR § 5-108. Denial, revocation, or suspension of registration.

(a) An application may be denied or a certificate of registration revoked or suspended as outlined in 42 C.F.R § 73.8.

(b) Any person may appeal a denial, revocation, or suspension of registration as stated in 42 C.F.R. § 73.20.

20 CAR § 5-109 Civil money penalties {#sec-20-car-5-109 omnilex-key=us-ar-regs-official--title-20-part-5--20 CAR § 5-109}

20 CAR § 5-109. Civil money penalties.

The Department of Health shall impose a civil penalty for a willful or knowing violation of this part in the amount of up to one thousand dollars ($1,000).