VII-99.01(A)

UMB Policy on Access to Biological Select Agents and Toxins

Human Resources   |   Approved June 1, 2013

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Responsible VP/AVP

Dawn M. Rhodes, DBA, MBA

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Policy Statement

1.  PURPOSE

 University of Maryland, Baltimore (UMB) employees or students who have access to biological select agents and toxins (BSAT) controlled by the US Department of Health and Human Services Centers for Disease Control and Prevention (CDC) or the US Department of Agriculture Animal and Plant Inspection Service (APHIS) must comply with applicable federal and state laws.  UMB oversees access to BSAT at UMB and in off-campus facilities controlled by UMB.  This Policy establishes responsibilities and procedures for exercise of UMB’s oversight of access to BSAT.

 This Policy does not authorize any person to engage in any act related to BSAT that is not authorized or permitted under federal or state laws or regulations.  In the event of any conflict between this Policy and applicable laws or regulations, the laws or regulations will take precedence. 

2. SCOPE 

This Policy applies to UMB employees and students whose work requires them to have access to BSAT.  

 

3.   DEFINITIONS

Access – The ability of a UMB employee or student to have access to or gain possession of BSAT; for example, the ability to carry, use, or manipulate BSAT.

ARO - Alternate Responsible Official. The official designated by the Responsible Official as having authority and control to ensure compliance with the CDC or the APHIS BSAT regulations in the absence of the Responsible Official.

Authorized Person – A UMB employee or student recommended by UMB and approved by the US Department of Health and Human Services Secretary or Administrator, following a security risk assessment by the US Attorney General, to have access to BSAT.

AVP/HRS – UMB Associate Vice President for Human Resources.

AVP/PS – UMB Assistant Vice President for Public Safety and Chief of Police.

BSAT – Biological Select Agent or Toxin. Any biological agent or toxin listed in 42 CFR Part 73, 7 CFR Part 331, or 9 CFR Part 121 as a select agent or toxin that is not otherwise excluded from the regulations or is a toxin in an amount under the control of a principal investigator, treating physician or veterinarian that does not exceed levels specified in the regulations.

CO – Certifying Official.  The AVP/HRS, who is designated as the official employed by UMB with operational responsibility for its Suitability Assessment Program.

HRS – UMB Office of Human Resource Services.

Public Safety – The UMB Department of Public Safety, which includes the UMB Police Department.

REV – Reviewer. The Assistant Vice President for Public Safety and Chief of Police is designated as the REV and has responsibility for monitoring the Suitability Assessment Program.

RO - Responsible Official.  The  UMB Biosafety Officer designated by the President as the RO.  The RO has full delegated authority and control to ensure compliance with the BSAT regulations throughout UMB.

Suitability Assessment Program – A process for conducting both pre-access and ongoing assessments of the suitability of an employee, student, or applicant for employment for Access to Tier 1 BSAT.

Tier 1 BSAT – BSAT that are identified in the CDC or APHIS regulations as requiring additional physical and personnel security measures.

SVPAF – UMB Senior Vice President for Administration and Finance.

 

4.   RESPONSIBILITIES

           The following UMB officials and offices have the responsibilities stated:

a.         UMB President –

1)     Communicates to the research community UMB’s responsibility for and commitment to compliance with BSAT regulations.

2)      Delegates authority to the RO to ensure UMB compliance with BSAT regulations.

3)     3)  Makes adequate fiscal, administrative and personnel resources available to implement a BSAT program in a lawful and effective manner.

b.         The RO –

1)     Ensures compliance with the applicable federal regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121), and any successor or additional regulations relevant to BSAT access at and through UMB.

2)     Ensures compliance with Annotated Code of Maryland Health-General Article 17-601 – 17-605 and its implementing regulation COMAR 10.10.11 as they relate to  BSAT access at and through UMB.

3)     Works directly with the SVPAF and the UMB Deans and Vice Presidents to facilitate effective and immediate action on behalf of UMB management, especially in the event of emergency, in carrying out a BSAT program.

4)     Develops and implements plans for biosafety, security, and incident response, conducts training for Authorized Persons, conducts annual reviews, plans and executes annual drills to test plan effectiveness.

5)     Coordinates with AVP/PS and the AVP/HRS to ensure that pre-access and on-going suitability assessments for Authorized Persons with Access to Tier 1 BSAT are conducted as required by regulation.

6)     Ensures that annual inspections of BSAT registered areas are conducted. Inspections include reviews of biosafety, security, incident response, and inventory records.

7)     Responds in a timely manner to onsite incidents involving BSAT in accordance with the UMB Emergency Management Plan.

8)     Maintains records required for BSAT registration with CDC or APHIS.

9)     Notifies CDC or APHIS of changes in Authorized Persons, addition or removal of registered facilities, added or deleted BSAT, inter-entity transfers of BSAT, and theft, loss, or release of BSAT.

c.         AVP/HRS (CO) –

1)     Develops and operates the university’s Suitability Assessment Program.

2)     Evaluates the background information developed by HRS for individuals for whom status as an Authorized Person with Access to Tier 1 BSAT is sought and ensures the conduct of interviews with such persons, as appropriate,  at intervals specified in the Suitability Assessment Program.

3)     Certifies to the RO that each Authorized Person with Access to Tier 1 BSAT has met the university’s criteria, under its Suitability Assessment Program, to be an Authorized Person.

4)     Conveys denials of access decisions to managers and employee/applicants.

5)     Establishes a process for reconsideration of negative suitability determinations.

6)     Notifies the RO on other matters pertinent to personnel suitability as Authorized Persons.

d.         AVP/PS (REV) –

1)   Monitors the overall effectiveness of the Suitability Assessment Program, and reviews suitability determinations as requested by the CO or otherwise under the Suitability Assessment Program.

e.         Authorized Person –

1)     Completes initial and annual training for BSAT.

2)     Maintains an accurate inventory of BSAT under his/her control.  

3)     Supervises Access to BSAT under his/her control by Authorized Persons and prohibits Access to BSAT by persons not authorized for Access.

4)     Notifies the RO whenever an Authorized Person leaves UMB or ceases to have responsibilities for BSAT for which the Authorized Person has been responsible.  If applicable, notifies the RO of the proposed replacement for such an Authorized Person.

5)     Upon discovery, reports any known or reasonably suspected inventory discrepancies,  diversions, thefts or losses of BSAT to the RO and Public Safety.

f.          Public Safety –

1)     Consults with the RO, ARO, and Authorized Persons on the adequacy of security and storage facilities for BSAT. 

2)     In consultation with the RO, investigates reports of inventory discrepancies, diversion, theft or loss of BSAT.

3)     Mounts an appropriate security response within 15 minutes of notification of a security breach involving BSAT.

g.         HRS –

1)     Ensures the conduct of background investigations of individuals for whom initial status as an Authorized Person with Access to Tier 1 BSAT is requested, and updates background investigations at the intervals required by the Suitability Assessment Program. Background investigations will include verification of residence, educational credentials, visa status, and other matters as required by the Suitability Assessment Program and/or the BSAT regulations.

2)     Evaluates information obtained from such background investigations  and communicates the evaluation to the CO.

5.  REQUIREMENTS

 a. Access to BSAT

UMB employees and students who have Access to BSAT and/or TIER 1 BSAT prior to the date this Policy becomes effective are required to comply with the elements of this Policy as of its effective date.

 UMB employees and students who require status as an Authorized Person after the effective date of this Policy are required to contact the RO and follow the procedures established by the RO for compliance with this Policy.

b. UMB Registration with CDC or APHIS

The RO will register UMB for the possession, use, and transfer of BSAT with CDC or APHIS as appropriate. As warranted by the objectives of UMB research programs, the RO will amend the UMB registration to reflect changes in the use of select agents or toxins, changes in the roster of Authorized Persons, and changes in facilities where select agents are stored and used.

c.  Approval of Authorized Persons for Access to Tier 1 BSAT

Through the Suitability Assessment Program, the CO must certify an individual as an Authorized Person before the individual can have access to Tier 1 BSAT.

For a current employee proposed to be an Authorized Person with Access to Tier 1 BSAT, the CO’s decision will be based primarily, though not exclusively, upon the pre-hire background investigation report concerning the person that is on file at HRS.  If any person proposed as an Authorized Person does not have a pre-hire report on file (i.e., is a new hire, was hired before UMB began seeking pre-hire background reports, or is a student), or the report on file is more than five (5) years old, HRS will request a new background investigation report.  The report requested will be consistent in scope with reports required by UMB for new employees.   

If the CO determines that an individual should not be approved as an Authorized Person with Access to Tier 1 BSAT, the CO will notify the individual, the RO, and the REV.   The CO will include in the notice information sufficient to explain in general terms the reason for the negative decision, but will not disclose specific criminal history information to the RO or the REV. 

If a person determined not suitable to be an Authorized Person with Access to Tier 1 BSAT status is a current employee or student who had responsibilities involving Tier 1 BSAT upon implementation of this Policy, or is a current employee or student being considered for new responsibilities involving Tier 1 BSAT, the employee or student may request a meeting with the CO to review the reason for the decision.   A request must be made in writing to the CO within five (5) business days after the CO provides notice of a negative decision.  With the individual’s consent, a representative of the Human Resources staff of the subject’s school will be invited to attend the meeting.   The CO may request the REV to participate in the meeting.

Following the meeting, reevaluation of the person may be requested if information can be presented showing that the CO was furnished incorrect or incomplete information that was taken into account in making a negative determination.

 d.         Oversight of the Suitability Assessment Program

The REV will review the CO’s management of the Suitability Assessment Program and compliance with this Policy at least once every 12 months.  More frequent reviews are at the REV’s discretion.  More frequent reviews may be initiated by the REV due to concerns about compliance with this Policy and the law, and also may be requested by the CO, the SVPAF, the RO, any Authorized Person, or an Authorized Person’s supervisor or Dean, if there are concerns about compliance with this Policy.