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Francisella (Pasteurella) tularensis. Hemorrhagic fever agents including, but not

limited to, Crimean hemorrhagic fever (Congo), Junin, Machupo viruses, and Ko

rean hemorrhagic fever viruses. Herpesvirus simiae (B virus). Histoplasma capsulatum. Lassa virus. Marburg virus. Pseudomonas mallei. Pseudomonas pseudomallei. Tick-borne encephalitis virus complex in

cluding, but not limited to, Russian springsummer encephalitis, Kyasanur forest disease, Omsk Hemorrhagic fever, and Central European encephalitis viruses, Variola

minor, and Variola major. Variola major, Variola minor, and Whitepox

viruses. Yersinia (Pasteurella) pestis. 3

(2) The color of material on which the label is printed must be white, the symbol red, and the printing in red or white as illustrated.

(3) The label must be a rectangle measuring 51 millimeters (mm) (2 inches) high by 102.5 mm (4 inches) long.

(4) The red symbol measuring 38 mm (142 inches) in diameter must be centered in a white square measuring 51 mm (2 inches) on each side.

(5) Type size of the letters of label shall be as follows: Etiologic agents—10 pt. rev. Biomedical material-14 pt. In case of damage or leakage-10 pt. rev. Notify Director CDC, Atlanta, Georgia-8 pt.

rev. 404-633-5313—10 pt. rev.

(e) Damaged packages. The carrier shall promptly, upon discovery of evidence of leakage or any other damage to packages bearing an Etiologic Agents/Biomedical Material label, isolate the package and notify the Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333, by telephone: (404) 633–5313. The carrier shall also notify the sender.

(f) Registered mail or equivalent system. Transportation of the following etiologic agents shall be by registered mail or an equivalent system which requires or provides for sending notification of receipt to the sender immediately upon delivery: Coccidioides immitis. Ebola virus.

$72.4 Notice of delivery; failure to re

ceive. When notice of delivery of materials known to contain or reasonably believed to contain etiologic agents listed in $72.3(f) is not received by the sender within 5 days following anticipated delivery of the package, the sender shall notify the Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333 (telephone (404) 633–5313).

3 This list may be revised from time to time by Notice published in the FEDERAL REGISTER to identify additional agents which must be transported in accordance with requirements contained in $72.3(f).

as

$72.5 Requirements; variations.

(3) Such registration shall remain efThe Director, Center for Disease Con

fective until relinquished by the faciltrol, may approve variations from the

ity or withdrawn by the Secretary or requirements of this section if, upon

the registering entity. review and evaluation, it is found that

(4) The registration may be denied or such variations provide protection at

withdrawn by the registering entity or least equivalent to that provided by

the Secretary based on: compliance with the requirements

(i) Evidence that the facility is not or specified in this section and such find

is no longer capable of handling covings are made a matter of official

ered agents at the applicable biosafety record.

level;

(ii) Evidence that the facility has $ 72.6 Additional requirements for fa- handled covered agents in a manner in

cilities transferring or receiving se- contravention of the applicable biolect agents.

safety level requirements; (a) Registration of facilities. (1) Prior (iii) Evidence that the facility has or to transferring or receiving a select intends to use covered agents in a managent listed in Appendix A of this part, ner harmful to the health of humans; a facility shall register with a reg- (iv) Evidence that the facility has istering entity authorized by the Sec- failed to comply with any provisions of retary (paragraph (c) of this section) or this part or has acted in a manner in be approved by the Secretary contravention of this part; or equipped and capable of handling the

(v) Failure to pay any required regcovered agent at Biosafety Level (BL) istration fee. 2, 3, or 4, depending on the agent.

(5) The requirements for BSL-2, 3, (2) Registration will include:

and 4 operations pertaining to this sec(i) Sufficient information provided by tion are contained in the CDC/NIH pubthe responsible facility official indi- lication, “Biosafety in Microbiological cating that the applicant facility, and and Biomedical Laboratories," Third its laboratory laboratories, Edition, May 1993 which is hereby inequipped and capable of handling the corporated by reference. The Director agents at BL 2, 3, or 4, depending upon

of the Federal Register has approved the agent, and the type of work being under 5 U.S.C. 552(a) and 1 C.F.R. Part performed with the agents;

51 the incorporation by reference of the (ii) Inspection of the applicant facil- above publication. Copies may be obity at the discretion of the Secretary tained from the Superintendent of Docor the registering entity in consulta- uments, U.S. Government Printing Oftion with the Secretary;

fice, Washington D.C. 20402. Copies may (iii) Issuance by the registering enti- be inspected at the Centers for Disease ty of a registration number unique to Control and Prevention, 1600 Clifton each facility;

Road, Atlanta, Georgia, or at the Office (iv) Collection of a periodic site reg- of the Federal Register, 800 North Capistration fee by the registering entity itol Street N.W., Suite 700, Washington or the Secretary.

D.C. A schedule of fees collected by the (6) Additional specific requirements Secretary to cover the direct costs for handling toxins subject to this part (e.g., salaries, equipment, travel) and must be met and are found in 29 CFR indirect costs (e.g., rent, telephone $ 1910.1450, “Occupational Exposure to service and a proportionate share of Hazardous Chemicals in Laboratories.” management and administration costs) (b) Appeals. A decision made by the related to administration of this part Secretary or a registering entity to will be published in the FEDERAL REG- deny or withdraw registration of a parISTER and updated annually.

ticular facility may be appealed to the (v) Follow-up inspections of the facil- Secretary. An application for appeal ity by the registering entity or the must be received by the Secretary no Secretary, as appropriate, to ensure later than 14 days after the appealing the facility continues to meet approved party's application for registration was standards and recordkeeping require- denied or no later than 14 days after ments.

the appealing party's registration was

or

are

withdrawn. The application must clearly identify the issues presented by the appeal and fully explain the appealing party's position with respect to those issues. The Secretary may allow the filing of opposing briefs, informal conferences, or whatever steps the Secretary considers appropriate to fairly resolve the appeal.

(c) Authorized registering entities. (1) The Secretary may authorize a state agency or private entity to register facilities under paragraph (a) of this section, if the Secretary determines that the registering entity's criteria for determining the biosafety standards for facilities handling select agents are consistent with the requirements contained in the CDC/NIH publication “Biosafety in Microbiological and Biomedical Laboratories," Third Edition.

(2) A registering entity shall maintain:

(i) A database of all facilities formerly and currently registered as BL 2, 3, or 4 and capable of working with agents in Appendix A of this part. The database shall include the name and address of the registered facility, the date the facility was registered, the facility's registration number, and the name and phone number of the responsible facility official.

(ii) A copy of each CDC Form EA-101 transmitted by each transferor registered by that registering entity. Such forms shall be made readily accessible to the Secretary and to appropriate federal law enforcement authorities and/or authorized local law enforcement authorities.

(3) In the event the Secretary authorizes more than one registering entity, or if otherwise necessary, the Secretary may require the establishment of a consolidated database to carry out the provisions of $72.6(C)(2).

(d) Requests for agents. (1) Prior to the transfer of any agent contained in Appendix A of this part, a CDC Form EA101 must be completed for each transfer sought. As specified in CDC Form EA101, the information provided must include:

(i) The name of the requestor and requesting facility;

(ii) The name of the transferor and transferring facility;

(iii) The names of the responsible facility officials for both the transferor and requestor;

(iv) The requesting facility's registration number;

(v) The transferring facility's registration number;

(vi) The name of the agent(s) being shipped;

(vii) The proposed use of the agent(s); and

(viii) The quantity (number of containers and amount per container) of the agent(s) being shipped.

(2) The form must be signed by the transferor and requestor, and the responsible facility officials representing both the transferring and requesting facilities.

(3) A copy of the completed CDC Form EA-101 must be retained by both transferring and requesting facilities for a period of five (5) years after the date of shipment or for five (5) years after the agents are consumed or properly disposed, whichever is longer.

(4) All CDC forms EA-101 must be produced upon request to appropriate federal and authorized local law enforcement authorities, officials authorized by the Secretary, and officials of the registering entity.

(e) Verification of registration. (1) Prior to transferring any agent covered by this part, the transferor's responsible facility official must verify with the requestor's responsible facility official, and as appropriate, with the registering entity:

(i) That the requesting facility retains a valid, current registration;

(ii) That the requestor is an ployee of the requesting facility; and

(iii) That the proposed use of the agent by the requestor is correctly indicated on CDC Form EA-101.

(2) In the event that any party is unable to verify the information required in paragraph (e)(1) of this section, or there is suspicion that the agent may not be used for the requested purpose, then

the party shall immediately notify CDC.

(f) Transfer. (1) Upon completion of the CDC Form EA-101 and verification of registration, the transferring facility must comply with the packaging and shipping requirements in this part

em

or other applicable regulations when vaccine or otherwise detoxified for use transferring the agent.

in biomedical research procedures; or (2) The requesting facility's respon- (iii) The agent(s) is an exempted sible official must acknowledge receipt strain specified in Appendix A of this of the agent telephonically or other- part and/or CDC Form EA-101. Addiwise electronically within 36 hours of tional exemptions for otherwise covreceipt and provide a paper copy or fac

ered strains will be considered when simile transmission of receipt to the CDC reviews and updates the list of setransferor within 3 business days of re

lect agents (Appendix A of this part). ceipt of the agent.

Individuals seeking additions to the (3) Upon telephonic acknowledgment

list of exemptions should submit a reof receipt of the agent, the transferor

quest to CDC that specifies the agent shall provide a completed paper copy

or strain to be exempted and explains or facsimile transmission of CDC Form

why such an exemption should be EA-101 within 24 hours to the reg

granted. Future changes to the list of istering entity (holding that facility's

exemptions will be published in the registration), in accordance with

FEDERAL REGISTER for review and com$72.6(c)(2) for filing in a centralized re

ment prior to inclusion on Appendix A pository

of this part.

(2) Exemption of CLIA certified labora(8) Inspections. (1) Registering entities or the Secretary may conduct ran

tories: Clinical laboratories certified dom or for cause inspections of reg

under the Clinical Laboratory Improve

ment Amendments of 1988, (42 U.S.C. istered facilities to assure compliance

263a) (CLIA), that utilize these select with this part. All CDC forms EA-101

agents for diagnostic, reference, and records deemed relevant by in

verification, or proficiency testing purspecting officials must be produced upon request to authorized personnel

poses are exempt from the provisions of

$72.6. conducting these inspections. Inspec- (3) Procedures for facilities that are not tions may also include review of the

CLIA laboratories but are transferring or mechanisms developed by a facility to

receiving select agents to or from a CLIA track intrafacility transfers as well as

laboratory: Facilities that are not CLIA the facility's agent disposal proce

laboratories but are transferring or redures.

ceiving select agents to or from a CLIA (2) In addition, the Secretary may

laboratory must comply with the folconduct inspections of registering enti

lowing provisions. (No additional paties, and/or any consolidated database

perwork on behalf of CLIA laboratories established in accordance with

is required by this section.) $72.6(c)(3), to assure compliance with

(i) Prior to transferring a select this part.

agent subject to this part to a CLIA (h) Exemptions—(1) Exemptions for cer- laboratory for diagnostic, reference, tain select agents: Select agents other- verification, or proficiency testing purwise covered by this part are exempt poses, the transferor must: from its provisions if:

(A) Provide the following informa(i) The agent is part of a clinical tion on CDC Form EA-101: specimen intended for diagnostic, ref- (1) The name of the requestor and reerence, or verification purposes. Iso- questing facility; lates of covered agents from clinical (2) The name of the transferor and specimens shall be disposed of in ac- transferring facility; cordance with $72.6(i) after diagnostic, (3) The name of the transferor's rereference, or verification procedures sponsible facility official; have been completed;

(4) The requesting facility's CLIA (ii) The agent is a toxin having an certification number (which the transLDso for vertebrates of more than 100 feror must verify as valid and current nanograms per kilogram of body with the registering entity); weight which is used for legitimate (5) The transferring facility's regmedical purposes or biomedical re- istration number; search or is one of the listed toxins (6) The name of the agent(s) being which has been inactivated for use as a shipped;

(7) The proposed use of the agent(s); and

(8) The quantity (number of containers and amount per container) of the agent(s) being shipped.

(B) Verify receipt of the agent with the CLIA laboratory and note such receipt on CDC Form EA-101;

(C) Transmit a copy of the form, signed by the transferror and the responsible facility official representing the transfering facility, to the registering entity holding the transferring facility's registration; and

(D) Retain a copy of CDC Form EA101 in accordance with $ 72.6(d)(3) and $72.6(d)(4).

(ii) Prior to receiving a select agent listed in Appendix A of this part from a CLIA laboratory, the requestor must be registered in accordance with $72.6(a) and comply with the following requirements:

(A) Provide the following information on the CDC Form EA-101:

(1) The name of the requestor and requesting facility;

(2) The name of the transferor and transferring facility;

(3) The name of the requestor's responsible facility official;

(4) The transferring facility's CLIA certification number;

(5) The requesting facility's registration number;

(6) The name of the agent(s) being shipped;

(7) The proposed use of the agent(s); and

(8) The quantity (number of containers and amount per container) of the agent(s) being shipped.

(B) Upon receiving the agent, note such receipt on CDC Form EA-101;

(C) Transmit a copy of CDC Form EA-101, signed by the requestor and the responsible facility official representing the requesting facility, to the registering entity holding the requesting facility's registration;

(D) Retain a copy of the CDC Form EA-101 in accordance with $$72.6(d)(3) and 72.6(d)(4);

(E) Comply with the disposal requirements of $72.6(i) and all other sections of this part when subsequently transferring the agent.

(i) Agent disposal. (1) Upon termination of the use of the agent, all cultures and stocks of it will be

(i) Securely stored in accordance with prudent laboratory practices,

(ii) Transferred to another registered facility in accordance with this part, or

(iii) Destroyed on-site by autoclaving, incineration, or another recognized sterilization or neutralization process.

(2) When an agent, previously transferred to a facility in accordance with this part, is consumed or destroyed, the responsible facility official must formally notify the registering entity. Formal notification must be noted on CDC Form EA-101 and a copy kept on record by the responsible facility official for a period of five (5) years and is subject to paragraph (g) of this section.

(j) Definitions. As used in this section:

Facility means any individual or government agency, university, corporation, company, partnership, society, association, firm, or other legal entity located at a single geographic site that may transfer or receive through any means a select agent subject to this part.

Registering entity means an organization or state agency authorized by the Secretary to register facilities as capable of handling select agents at Biosafety Level 2, 3, or 4, depending on the agent, in accordance with the CDC/NIH publication "Biosafety in Microbiological and Biomedical Laboratories."

Requestor means any person who receives or seeks to receive through any means a select agent subject to this part from any other person.

Responsible facility official means an official authorized to transfer and receive select agents covered by this part on behalf of the transferor's and/or requestor's facility. This person should be either a safety officer, a senior management official of the facility, or both. The responsible facility official should not be an individual who actually transfers or receives an agent at the facility.

Secretary means the Secretary of the Department of Health and Human Services or her or his designee.

Select agent means a microorganism (virus, bacterium, fungus, rickettsia)

190-164 D-00--18

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