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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 (1122 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.

872.4 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).

$72.5 Requirements; variations.

The Director, Center for Disease Control, may approve variations from the requirements of this section if, upon review and evaluation, it is found that such variations provide protection at least equivalent to that provided by compliance with the requirements specified in this section and such findings are made a matter of official record.

as

or

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§ 72.6 Additional requirements for fa

cilities transferring or receiving se

lect agents. (a) Registration of facilities. (1) Prior to transferring or receiving a select agent listed in Appendix A of this part, a facility shall register with a registering entity authorized by the Secretary (paragraph (c) of this section) or be approved by the Secretary equipped and capable of handling the covered agent at Biosafety Level (BL) 2, 3, or 4, depending on the agent.

(2) Registration will include:

(i) Sufficient information provided by the responsible facility official indicating that the applicant facility, and its laboratory laboratories, equipped and capable of handling the agents at BL 2, 3, or 4, depending upon the agent, and the type of work being performed with the agents;

(ii) Inspection of the applicant facility at the discretion of the Secretary or the registering entity in consultation with the Secretary;

(iii) Issuance by the registering entity of a registration number unique to each facility;

(iv) Collection of a periodic site registration fee by the registering entity or the Secretary.

A schedule of fees collected by the Secretary to cover the direct costs (e.g., salaries, equipment, travel) and indirect costs (e.g., rent, telephone service and a proportionate share of management and administration costs) related to administration of this part will be published in the FEDERAL REGISTER and updated annually.

(v) Follow-up inspections of the facility by the registering entity or the Secretary, as appropriate, to ensure the facility continues to meet approved standards and recordkeeping requirements.

(3) Such registration shall remain effective until relinquished by the facility or withdrawn by the Secretary or the registering entity.

(4) The registration may be denied or withdrawn by the registering entity or the Secretary based on:

(i) Evidence that the facility is not or is no longer capable of handling covered agents at the applicable biosafety level;

(ii) Evidence that the facility has handled covered agents in a manner in contravention of the applicable biosafety level requirements;

(iii) Evidence that the facility has or intends to use covered agents in a manner harmful to the health of humans;

(iv) Evidence that the facility has failed to comply with any provisions of this part or has acted in a manner in contravention of this part; or

(v) Failure to pay any required registration fee.

(5) The requirements for BSL-2, 3, and 4 operations pertaining to this section are contained in the CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories," Third Edition, May 1993 which is hereby incorporated by reference. The Director of the Federal Register has approved under 5 U.S.C. 552(a) and 1 C.F.R. Part 51 the incorporation by reference of the above publication. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington D.C. 20402. Copies may be inspected at the Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, Georgia, or at the Office of the Federal Register, 800 North Capitol Street N.W., Suite 700, Washington D.C.

(6) Additional specific requirements for handling toxins subject to this part must be met and are found in 29 CFR $1910.1450, “Occupational Exposure to Hazardous Chemicals in Laboratories."

(b) Appeals. A decision made by the Secretary or a registering entity to deny or withdraw registration of a particular facility may be appealed to the Secretary. An application for appeal must be received by the Secretary no later than 14 days after the appealing party's application for registration was denied or no later than 14 days after the appealing party's registration was

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. (8) Inspections. (1) Registering enti

(2) Exemption of CLIA certified labora

tories: Clinical laboratories certified ties or the Secretary may conduct random or for cause inspections of reg

under the Clinical Laboratory Improveistered facilities to assure compliance

ment Amendments of 1988, (42 U.S.C.

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

poses are exempt from the provisions of upon request to authorized personnel

$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 of 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); (i) Agent disposal. (1) Upon termiand

nation of the use of the agent, all cul(8) The quantity (number of con- tures and stocks of it will be tainers and amount per container) of (i) Securely stored in accordance the agent(s) being shipped.

with prudent laboratory practices, (B) Verify receipt of the agent with

(ii) Transferred to another registered the CLIA laboratory and note such re- facility in accordance with this part, or ceipt on CDC Form EA-101;

(iii) Destroyed on-site by (C) Transmit a copy of the form,

autoclaving, incineration, or another signed by the transferror and the re

recognized sterilization or neutralizasponsible facility official representing

tion process. the transfering facility, to the reg

(2) When an agent, previously transistering entity holding the transferring

ferred to a facility in accordance with facility's registration; and

this part, is consumed or destroyed, (D) Retain a copy of CDC Form EA

the responsible facility official must 101 in accordance with $72.6(d)(3) and

formally notify the registering entity.

Formal notification must be noted on $72.6(d)(4).

CDC Form EA-101 and a copy kept on (ii) Prior to receiving a select agent

record by the responsible facility offilisted in Appendix A of this part from

cial for a period of five (5) years and is a CLIA laboratory, the requestor must

subject to paragraph (g) of this section. be registered in accordance with

(j) Definitions. As used in this section: § 72.6(a) and comply with the following

Facility means any individual or govrequirements:

ernment agency, university, corpora(A) Provide the following informa

tion, company, partnership, society, tion on the CDC Form EA-101:

association, firm, or other legal entity (1) The name of the requestor and re- located at a single geographic site that questing facility;

may transfer or receive through any (2) The name of the transferor and means a select agent subject to this transferring facility;

part. (3) The name of the requestor's re- Registering entity means an organizasponsible facility official;

tion or state agency authorized by the (4) The transferring facility's CLIA Secretary to register facilities as capacertification number;

ble of handling select agents at Bio(5) The requesting facility's registra- safety Level 2, 3, or 4, depending on the tion number;

agent, in accordance with the CDC/NIH (6) The name of the agent(s) being

publication "Biosafety in Microshipped;

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

tories." and

Requestor means any person who re

ceives or seeks to receive through any (8) The quantity (number of containers and amount per container) of

means a select agent subject to this

part from any other person. the agent(s) being shipped.

Responsible facility official means an (B) Upon receiving the agent, note

official authorized to transfer and resuch receipt on CDC Form EA-101;

ceive select agents covered by this part (C) Transmit a copy of CDC Form

on behalf of the transferor's and/or reEA-101, signed by the requestor and the

questor's facility. This person should responsible facility official rep

be either a safety officer, a senior manresenting the requesting facility, to

agement official of the facility, or the registering entity holding the re- both. The responsible facility official questing facility's registration;

should not be an individual who actu(D) Retain a copy of the CDC Form

ally transfers or receives an agent at EA-101 in accordance with $872.6(d)(3) the facility. and 72.6(d)(4);

Secretary means the Secretary of the (E) Comply with the disposal require Department of Health and Human ments of $72.6(i) and all other sections Services or her or his designee. of this part when subsequently trans- Select agent means a microorganism ferring the agent.

(virus, bacterium, fungus, rickettsia)

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