Attachment D - PIADC Personnel Reliability Program (PRP) 11Jun2021.pdf

For the best experience, open this PDF portfolio in

Acrobat X or Adobe Reader X, or later.

Get Adobe Reader Now!

http://www.adobe.com/go/reader

Please wait...

If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.

Enrollees Information Section

For Official Use Only

Plum Island Animal Disease Center (PIADC)

Personnel Reliability Program Enrollment Form

Revision: 18Jul19

File Plan #: TBD

Required Access: (check all that apply)

After conducting reference checks and the initial interview, I am recommending that this person be enrolled in the PIADC Select Agent Personnel Reliability Program. If reference checks and interviews were not conducted please justify the reason in the comment space below.

Certifying Officials Section

PrintButton1:

ResetButton1:

TextField3:

TextField4:

TextField5:

TextField6:

TextField7:

TextField8:

DropDownList1:

DropDownList2:

TextField9:

CheckBox1:

TextField10:

SignatureField1:

DateTimeField1:

TextField11:

viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other

Suitability Assessment Item

YES / NO

Additional Information

Does the individual's duties still require access to BSATs and/or BSAT information?

Have any reportable conditions, behaviors or SRA clearance prohibitions or restrictions been observed or identified for the individual? [If yes, explain in detail, include relevant dates/times. Use back of this from for additional space]

Should this individual continue to have access to BSATs and/or BSAT information?

File Plan #: TBD Rev. Date: 7/8/16 Page 1 of 1

Plum Island Animal Disease Center (PIADC) Reliability Annual Supervisor Assessment Form

My answer to each question is truthful and accurate to the best of my knowledge and belief.

11.0.0.20130303.1.892433.887364

DropDownList1:

TextField1:

ResetButton1:

PrintButton1:

TextField3:

DateTimeField1:

SignatureField1:

TextField2:

viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other

Plum Island Animal Disease Center

Potentially Disqualifying Information Disclosure to

Medical Reviewing Official

File Plan #: TBD

Potentially Disqualifying Information for Entry into Biocontainment / Enrollment into the Personnel Reliability Program

Pre Screen Evaluation Self-Disclosure to Medical Reviewing Official

Check any of the below Potentially Disqualifying Information that apply to you:

Rev. Date: 12/14/15

Medical Reviewing Official Review

By signing below, I certify that all of the information I have provided on this form is complete and accurate to the best of my knowledge, and acknowledge submitting information that is incomplete, misleading, or untruthful may result in administrative or disciplinary action.

PrintButton1:

TextField4:

CheckBox2:

TextField5:

TextField6:

SignatureField4:

DateTimeField3:

ResetButton1:

EmployeeSignature:

EmployeeDateSigned:

viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other

PART I - RECOMMENDATIONS FOR DISQUALIFICATION

Plum Island Animal Disease Center

Interim Notification of Potentially Disqualifying Information

Revision: December 2015

PIADC Personnel General Information

File Plan#: TBD

Reason for Notification:

PART II - Reliability Assessment Board Review

RAB Summary:

RAB Decision:

Plum Island Animal Disease Center

Interim Notification of Potentially Disqualifying Information

Revision: December 2015

For Official Use Only

File Plan#: TBD

PART III - Status of Personnel Action

Summary:

RAB Final Decision:

TextField4:

DateTimeField1:

SignatureField1:

PrintButton1:

TextField1:

ResetButton1:

DateTimeField2:

SignatureField2:

Plum Island Animal Disease Center

Personnel Reliability Assessment Board Charter

June 2020

Title: PRAB Charter Rev. Date: 15June2020 File Plan #: 401-123-001h

Revision History

Rev. Date Reason for Revision June 15, 2020 Initial Release

Title: PRAB Charter Rev. Date: 15June2020 File Plan #: 401-123-001h

Personnel Reliability Assessment Board Charter

1.0. Purpose

The purpose of this Charter is to ensure the Plum Island Animal Disease Center (PIADC) is compliant with the United States Code of Federal Regulations 9 part 121 (9 CFR 121) requirement that individuals with access to Tier 1 select agents are subject to ongoing assessment of personal reliability for continued access to select agents. To this end, PIADC has chartered a select agent Personnel Reliability Assessment Board (PRAB) to ensure the PIADC select agent program is in compliance with 9 CFR 121 requirements.

The purpose of the PIADC Personnel Reliability Assessment Board is to evaluate and disposition personnel incidents that risk the loss, theft or release of Tier 1 select agents. To ensure compliance with federal and PIADC Personnel Reliability Program (PRP) policies, regulations and management directives, the Personnel Reliability Assessment Board will review staff reliability incidents concerning actions by PIADC staff registered with the PIADC select agent program (DHS, ARS, APHIS and contractors) including, but not limited to, information regarding the behavior of registered staff at PIADC facilities or off-site.

2.0. Introduction

The mission of Plum Island Animal Disease Center (PIADC) is to protect the United States from the accidental or intentional introduction of transboundary or foreign animal diseases (FADs) such as foot-and-mouth disease virus (FMDv) that may harm livestock industries, food security and the economy. PIADC is a biosafety-level 3 laboratory facility and the only United States laboratory that can possess and manipulate live, viable FMD virus. The U.S. Code of Federal Regulations (CFR) 9 Part 121 classifies viable FMD virus as a Tier 1 select agent requiring strict security and personnel reliability procedures. Federal select agent regulations define requirements for an individual to access Tier 1 biological select agents and toxins (BSAT), including the requirement for enrollment in a personnel reliability program to help ensure the ongoing reliability of staff approved for access to Tier 1 select agents.

3.0. Scope

The scope of this Charter establishes the PIADC Personnel Reliability Assessment Board to ensure compliance with 9 CFR 121 and the PIADC Personnel Reliability Program. The PRP guidance and operating procedures are specified in the PRP program documents as defined in the current PIADC Personnel Reliability Plan.

4.0. Roles and Responsibilities

4.1 Plum Island Animal Disease Center

PIADC acknowledges its responsibility to administer a personnel reliability program to be compliant with Federal Select Agent Program (FSAP) guidelines. The FSAP regulates access to select agents and specifies personnel reliability requirements for continued access to select agents. The PIADC Personnel Reliability Assessment Board is a key tool to safeguard biosurety of the select agents and the reliability of personnel at

PIADC.

Title: PRAB Charter Rev. Date: 15June2020 File Plan #: 401-123-001h

4.2 Personnel Reliability Assessment Board (PRAB): The PIADC PRAB is responsible for evaluating the reliability and trustworthiness of individuals to have continued access to select agents based on incidents of unacceptable behavior or other potentially disqualifying information. The PRAB provides the Responsible Official with recommendations concerning the continued access of reported individuals to biocontainment, select agents or select agent information.

The PRAB will be composed of the following PIADC staff members:

• Entity Official

• Responsible Official

• Director of Biorisk Management

• Certifying Official (Biosurety Officer)

• Reviewer (Security Manager)

• Biosafety Officer

• Other Subject Matter Experts, as needed

4.2.1 Entity Official (EO): The EO is responsible for overall implementation of the PIADC personnel reliability plan. The PIADC Director acts as the EO and has the authority to immediately restrict or deny access to biocontainment areas (select agent exclusion areas) based on behavioral, medical or administrative grounds. The EO has the authority to deny or reinstate biocontainment access. The RO has the authority to approve or deny select agent access at PIADC.

4.2.2 Responsible Official (RO): The RO is responsible for ensuring entity compliance with the select agent regulations and establishing and implementing procedures for conducting reliability assessments. The RO has the authority to immediately restrict or deny access to all BSATs based on behavioral, medical or administrative grounds. The RO is responsible for notifying the Federal Select Agent Program of permanent restrictions of personnel access to select agents and toxins through the submission of amendments to the entity’s FSAP registration. The RO convenes and conducts the PRAB meetings, and receives recommendations from the PRAB for personnel actions regarding access to select agents. The RO has the ultimate decision making authority for approving personnel access to select agents or select agent information at PIADC. The RO makes the final decision with input from the PRAB.

4.2.3 Director of Biorisk Management: The Director of Biorisk Management is responsible for overall management and coordination of biorisk mitigations and actions at PIADC. The Director of Biorisk Management has authority to take action against any violation of PIADC policies or procedures which affect the safety and security of personnel, the PIADC mission and the environment.

4.2.4 Certifying Official (CO): The Biosurety Officer is an Alternate Responsible (ARO) that serves as the

CO to ensure that personnel meet the requirements of PIADC’s Personnel Reliability Program. In the absence of the RO, the CO/ARO has the authority to act on the behalf of the RO and convene the PIADC Select Agent Personnel Reliability Assessment Board (PRAB) when potentially disqualifying information is found, and notify FSAP of changes in personnel status.

4.2.5 Reviewer (REV): The Security Manager will serve as the Security Officer to monitor the reliability assessments for security concerns, to recommend law enforcement actions and to review warranted reliability mitigations through periodic audits. The Security Officer has the authority to immediately restrict or deny access to PIADC based on security violations or concerns.

Title: PRAB Charter Rev. Date: 15June2020 File Plan #: 401-123-001h

The Security Officer provides an alternate and complementary perspective on the suitability assessment program and Tier 1 BSAT access decisions to the RO.

4.2.6 Biosafety Officer: The Biosafety Officer is responsible for overall biosafety at PIADC. The Biosafety

Officer will provide determinations of biosafety violations, incident severity and risk assessments to guide PRAB decisions. In the absence of the RO and the CO, has the authority to act on the behalf of the RO and convene the PIADC Select Agent Personnel Reliability Assessment Board (PRAB) when potentially disqualifying information is found, and notify FSAP of changes in personnel status.

4.2.7 Federal Officer : A Federal Officer / Criminal Investigator is a member of the RAB as needed. The

Federal Officer / Criminal Investigator is responsible for leading the investigation of any potential crimes at PIADC.

4.2.8 Other subject matter experts: Other subject matter experts may be called to participate in PRAB proceedings for specific incidents as appropriate, such as the ONL Biosurety Manager, the Occupational Health Physician, the senior manager for the staff member involved or human resources representative(s).

5.0. Policies and Procedures

Procedures for the PIADC Personnel Reliability Assessment Board to assess reports of potentially disqualifying behaviors or information to ensure the reliability of personnel with access to select agents and toxins, include:

5.1 Annual Review Meeting

The PRAB shall meet as necessary, but no less than once a year to conduct an annual meeting to review changes to FSAP regulations or PIADC policies pertinent to the personnel reliability program. At the annual review meeting, the PRAB shall review biosurety concerns within the scope of PRAB, including current status of corrective actions implemented over the previous 12 months. Prior to the annual review meeting, the Certifying Officer will submit an annual written report to the PRAB which will include an overview of PRAB incidents and actions over the previous 12 months. During the annual review meeting, the PRAB will consider if additional actions are necessary to address changes to PIADC personnel reliability risk or regulatory profile.

5.2 Investigation Procedures

A person’s reliability to access to Tier 1 BSAT is defined as not displaying behaviors determined by the entity that would likely increase the risk of a theft, loss or release of a select agent or toxin. See 9 CFR 121.10(g) for a list of possible concerning behaviors. Individuals are responsible for their own actions, and for reporting actions of both themselves and other individuals that violate FSAP and PIADC PRP guidelines.

Reportable conditions, behaviors or other information must be brought to a supervisor as soon as possible after the incident, observation or awareness. Reporting procedures are contained in the PRP Policy, Section 10 “How Information Should be Reported.”

5.2.1 For significant incidents, the PIADC RAB will meet and:

Title: PRAB Charter Rev. Date: 15June2020 File Plan #: 401-123-001h

5.2.2 Determine whether the concern merits involvement of Human Resources, whereupon a member of the RAB shall refer the person reporting the concern to the appropriate HR representative as soon as possible.

5.2.3 If the concern involves a potential criminal violation, then the referral is made to the Federal Officer/ Criminal Investigator. For criminal investigations, the information is shared with the Security Manager, RO and EO. The Federal Officer/Criminal Investigator will consult with the DHS Privacy Office or other appropriate official before disclosing information involving investigations. The Federal Officer/Criminal Investigator in conjunction with the RO will determine the need to inform the FBI.

5.2.4 Inform the reporting individual of the provisions of these reliability assessment procedures;

5.2.5 Notify the supervisor of the reported individual(s);

5.2.6 The supervisor will inform the reported individual of the existence of the concern and the provisions of these reliability assessment procedures;

5.2.7 Refer the concern to the PIADC Security Department for investigation, if required;

5.2.8 The PRAB will meet with the supervisor, reporting individual or reported individual to obtain information and evidence, including the identity of any witnesses;

5.2.9 Attempt to obtain information from the identified witnesses, written or electronic documentation, photographs, video or audio recordings, online evidence, or other sources of factual information regarding the report;

5.2.10 Maintain appropriate documentation;

5.2.11 Disclose only appropriate information to others consistent with state and federal law;

5.2.12 Determine whether the reported individual is eligible for access to classified information or occupies a sensitive national security position, and if it creates a concern about the individual’s continued eligibility for the position, in which case the information is provided to the Personnel Security Division in the DHS Office of the Chief Security Officer;

5.2.13 Make a recommendation to the RO whether access to biocontainment, BSATs or BSAT information should be restricted for the reported individual, pending further investigation or a final decision; The Security Manager will also evaluate the risk of the individual having access to PIADC property.

5.2.14 As needed, the RO may reconvene the PRAB to consider any new information, to perform a Whole Person Assessment of the individual, to determine if additional investigation is required, or to render a recommendation to the RO;

5.2.15 The RO makes a final decision regarding access of the reported individual to biocontainment, BSATs or BSAT information.

5.2.16 If the RO restricts reported individual access, or imposes requirements for continued access, then the reported individual has the right to appeal the decision. See Section 5.3.7 below.

5.2.17 If the RO finds for permanent restriction, then the reported individual has the right to appeal before the decision is communicated to the Office of National Laboratories and FSAP. See Section 5.3.7 below.

A PRAB quorum will require the RO and more than 50% of other board members to be present. A majority vote from the quorum is required for consensus on PRAB recommendations to the RO.

Title: PRAB Charter Rev. Date: 15June2020 File Plan #: 401-123-001h

During this process, the PRAB will keep the reported individual’s supervisor or administrator informed of the status of the concern and will seek input from the appropriate supervisor/administrator when implementing any corrective action. If the PRAB recommends that a personnel action or additional training is required, this will be referred to the reported individual’s first level supervisor, or agency/company Human Resources Office, for action as appropriate. The supervisor will report back to the PRAB of the corrective actions taken.

5.3 Other considerations;

5.3.1 Corrective action may not be possible and may be superseded if the issue concerns a potential violation of the law.

5.3.2 False reporting: The purpose of the reliability assessment procedures is to guard Tier 1 BSAT from misuse by an insider. Discovery of the abuse of the peer-reporting process (e.g., as a means to discredit others without just cause) will be reviewed by the PRAB as a reportable concern in itself. Depending on the severity of the abuse, the person who conducts the false reporting could have their access to Tier 1 BSAT, or all access to BSAT, removed for a period of time or indefinitely.

5.3.3 Investigative Data: During the investigation, the PRAB will keep private the information gathered during the investigation to the extent required by state and federal law. The PRAB shall restrict sharing identifiable information about staff or others involved on an authorized need-to-know basis.

5.3.4 Summary Action: The RO may impose a summary suspension of access to BSAT agents or information prior to the completion of the investigation and resolution of a concern when, in the judgment of the simple majority of the PRAB, the reported individual’s access to Tier 1 BSAT would constitute a threat to the safety and well-being of members of the PIADC community or the theft, loss, or release of a BSAT. If the reported individual’s access to BSAT is suspended, the formal process should be completed within the shortest reasonable time period possible, normally not to exceed 10 working days. During the summary suspension, the reported individual may not have access to BSAT without written permission from the RO or ARO.

Note: The RO can restrict access to BSATs or BSAT information at any time to protect the security of personnel and agents.

5.3.5 PRAB Action: The amount of time needed to conduct an investigation will depend in part on the nature of the allegation and the evidence to be investigated (e.g., the number and/or availability of witnesses involved). The PRAB will provide notice of the outcome of the investigation or will advise the reported individual’s management of the additional estimated amount of time needed for the investigation. Upon conclusion, the PRAB will notify the reported individual’s supervisors of the results of the investigation. In the event the investigation reveals that a violation of select agent regulations or other inappropriate or unprofessional conduct (even if not unlawful) has occurred, the PRAB may make a recommendation for the suspension of access.

The RO will consult with the DHS S&T Legal Counsel before taking any permanent actions.

5.3.6 Notification to Agricultural Select Agent Services: Self-reporting and “opt-outs” or voluntary removal (where defined periods of time are established) would not be reportable to the Federal Select Agent Program, whereas permanent restriction enforced by the RO, ARO or CO, or termination of access based on employment or need for access, will be reported to the Federal

Title: PRAB Charter Rev. Date: 15June2020 File Plan #: 401-123-001h

Select Agent Program and an amendment to the entity’s registration will be filed that reflects this change.

5.3.7 Appeal Process: If an individual believes that a determination is made in error, he/she may appeal to the RO in writing within 30 days from the date of the final decision. The individual is entitled to the information upon which the PRAB relied on in making its recommendation, to the extent the documents would be provided under the Freedom of Information Act (5 U.S.C. 552) or the Privacy Act (3 U.S.C. 552a), as applicable. The written appeal must be directed to the Responsible Official. The appeal must state all the facts and include written documentation as to why the determination is in error. Original documentation, when appropriate, must be included and may not be returned to the reported individual. The denial of access to BSATs will remain in effect during the appeal process. The RO may convene the PRAB and may include The Office of National Laboratories (ONL) Director to review the appeal documentation. The RO has the ultimate decision making authority regarding access to select agents and can override recommendations made by the PRAB or make a final decision when there is no consensus among PRAB members. The individual will be informed of the final decision in writing within 30 days of receiving the appeal.

5.3.8 Restoration of access to Tier 1 BSAT: If a person has had access to Tier 1 BSAT suspended or removed, or if a person opted out of Tier 1 BSAT access and believes he/she should regain that access, the individual will appeal to the RO in writing and the PRAB shall make recommendations to the RO on restoring access for that individual.

Animal Disease Center

4.2 Personnel Reliability Assessment Board (PRAB): The PIADC PRAB is responsible for evaluating the reliability and trustworthiness of individuals to have continued access to select agents based on incidents of unacceptable behavior or other potential...

4.2.2 Responsible Official (RO): The RO is responsible for ensuring entity compliance with the select agent regulations and establishing and implementing procedures for conducting reliability assessments. The RO has the authority to immediately restr...

4.2.4 Certifying Official (CO): The Biosurety Officer is an Alternate Responsible (ARO) that serves as the CO to ensure that personnel meet the requirements of PIADC’s Personnel Reliability Program. In the absence of the RO, the CO/ARO has the author...

4.2.5 Reviewer (REV): The Security Manager will serve as the Security Officer to monitor the reliability assessments for security concerns, to recommend law enforcement actions and to review warranted reliability mitigations through periodic audits

The Security Officer provides an alternate and complementary perspective on the suitability assessment program and Tier 1 BSAT access decisions to the RO.

4.2.6 Biosafety Officer: The Biosafety Officer is responsible for overall biosafety at PIADC. The Biosafety Officer will provide determinations of biosafety violations, incident severity and risk assessments to guide PRAB decisions. In the absence of ...

Procedures for the PIADC Personnel Reliability Assessment Board to assess reports of potentially disqualifying behaviors or information to ensure the reliability of personnel with access to select agents and toxins, include:

5.1 Annual Review Meeting

5.2 Investigation Procedures

5.2.1 For significant incidents, the PIADC RAB will meet and:

5.2.2 Determine whether the concern merits involvement of Human Resources, whereupon a member of the RAB shall refer the person reporting the concern to the appropriate HR representative as soon as possible.

5.2.3 If the concern involves a potential criminal violation, then the referral is made to the Federal Officer/ Criminal Investigator. For criminal investigations, the information is shared with the Security Manager, RO and EO. The Federal Officer/Cr...

5.2.4 Inform the reporting individual of the provisions of these reliability assessment procedures;

5.2.5 Notify the supervisor of the reported individual(s);

5.2.6 The supervisor will inform the reported individual of the existence of the concern and the provisions of these reliability assessment procedures;

5.2.7 Refer the concern to the PIADC Security Department for investigation, if required;

5.2.8 The PRAB will meet with the supervisor, reporting individual or reported individual to obtain information and evidence, including the identity of any witnesses;

5.2.9 Attempt to obtain information from the identified witnesses, written or electronic documentation, photographs, video or audio recordings, online evidence, or other sources of factual information regarding the report;

5.2.10 Maintain appropriate documentation;

5.2.11 Disclose only appropriate information to others consistent with state and federal law;

5.2.12 Determine whether the reported individual is eligible for access to classified information or occupies a sensitive national security position, and if it creates a concern about the individual’s continued eligibility for the position, in which c...

5.2.13 Make a recommendation to the RO whether access to biocontainment, BSATs or BSAT information should be restricted for the reported individual, pending further investigation or a final decision; The Security Manager will also evaluate the risk of...

5.2.14 As needed, the RO may reconvene the PRAB to consider any new information, to perform a Whole Person Assessment of the individual, to determine if additional investigation is required, or to render a recommendation to the RO;

5.2.15 The RO makes a final decision regarding access of the reported individual to biocontainment, BSATs or BSAT information.

5.2.16 If the RO restricts reported individual access, or imposes requirements for continued access, then the reported individual has the right to appeal the decision. See Section 5.3.7 below.

5.2.17 If the RO finds for permanent restriction, then the reported individual has the right to appeal before the decision is communicated to the Office of National Laboratories and FSAP. See Section 5.3.7 below.

During this process, the PRAB will keep the reported individual’s supervisor or administrator informed of the status of the concern and will seek input from the appropriate supervisor/administrator when implementing any corrective action. If the PRAB ...

5.3 Other considerations;

5.3.1 Corrective action may not be possible and may be superseded if the issue concerns a potential violation of the law.

5.3.2 False reporting: The purpose of the reliability assessment procedures is to guard Tier 1 BSAT from misuse by an insider. Discovery of the abuse of the peer-reporting process (e.g., as a means to discredit others without just cause) will be revi...

5.3.3 Investigative Data: During the investigation, the PRAB will keep private the information gathered during the investigation to the extent required by state and federal law. The PRAB shall restrict sharing identifiable information about staff or ...

5.3.4 Summary Action: The RO may impose a summary suspension of access to BSAT agents or information prior to the completion of the investigation and resolution of a concern when, in the judgment of the simple majority of the PRAB, the reported indivi...

5.3.5 PRAB Action: The amount of time needed to conduct an investigation will depend in part on the nature of the allegation and the evidence to be investigated (e.g., the number and/or availability of witnesses involved). The PRAB will provide noti...

5.3.6 Notification to Agricultural Select Agent Services: Self-reporting and “opt-outs” or voluntary removal (where defined periods of time are established) would not be reportable to the Federal Select Agent Program, whereas permanent restriction en...

5.3.7 Appeal Process: If an individual believes that a determination is made in error, he/she may appeal to the RO in writing within 30 days from the date of the final decision. The individual is entitled to the information upon which the PRAB relied ...

5.3.8 Restoration of access to Tier 1 BSAT: If a person has had access to Tier 1 BSAT suspended or removed, or if a person opted out of Tier 1 BSAT access and believes he/she should regain that access, the individual will appeal to the RO in writing a...

For the best experience, open this PDF portfolio in

Acrobat X or Adobe Reader X, or later.

Get Adobe Reader Now!

http://www.adobe.com/go/reader

Occupational Health Physical Exam Supervisor Component Selection Form Matrix

File Plan: File Plan: GRS 2.7, Item 060 Rev. Date: 3/13/17 Page 3 of 3

PIADC Matrix

Fo rm

(s ) R eq ui re d fo r A ll Ex am T yp es

Exams Tests

Exam Type

Ph ys ic al

E xa m (w ith V

S)

Co pr eh en siv e Vi sio n

(ti tm us ac hi ne

Be st

V isi on (e ye c ha rt

Co lo r V isi on

Li ite

Ex am

(V ita ls O nl y)

Bl oo te

U rin al ys is

Sp iro et ry (b at hi ng

Ch t X -R ay (o pt io na l)

Au di om et ry (h ea rin g

PP

D

(tu be rc ul os is

EK

G

St ss

Se ru

B an ki ng (P hl eb ot om y)

Ra bi

T ite r, Te ta nu s B oo er , F lu

Va cc in e

Respirator - Non SCBA Baseline Exam

Respirator - Non SCBA Periodic Exam

SCBA - Baseline Exam

SCBA - Periodic Exam

Fire Brigade Exam - Baseline

Fire Brigade Exam - Periodic

Commercial Driver's License Exam

Formaldehyde Exposure

Merchant Mariner (Coast Guard) Exam

Biocontainment Entry Clearance Exam (Full Exam)

Biocontainment Entry Clearance Exam (Interim Exam)

Hearing Conservation Program

Animal Contact (Rabies, Tetanus, Flu)

Serum Banking

Asbestos Baseline Exam

Asbestos Interim Exam

Emergency Medical Tech/Paramedic Exam

Request for Respirator Medical Clearance

Agency Name:Employee Name:

Job Title: SS#:

Work Phone & Ext: Best Time to Phone:

Instructions to Safety Officer or Supervisor: Please check all respirators and other applicable items that apply to the employee's job functions, sign and print your name and the date of the request. Forward this form to the servicing examination facility or your clinic's contact person so that a medical evaluation of the employee can be scheduled.

Request for NIOSH-approved respirator:

single use, filtering face piece respirator full-faced cartridge-type, negative pressure full-faced powered cartridge-type (PAPR) hood/helmet powered cartridge-type (PAPR) - (not positive pressure) half-faced cartridge-type, negative pressure half-faced powered cartridge-type (PAPR) self-contained breathing apparatus (SCBA) half faced/full faced/hood/helmet positive pressure airline respirator

Frequency of Use:

daily monthly emergency use only other:

weekly yearly

Duration of Use:

< 30 min per work day

30 - 60 min per work day

1 - 4 hours per work day

4 - 8 hours per work day, or more

Other Personal Protective Equipment (PPE) to be Used:

Job Functions While the Employee Will be Wearing the Respirator (check all that apply) :

regular job duties require use of respirator; please refer to position description for these activities light physical activity (sitting or standing to control machines, performing hand or arm work) moderate physical activity (walking about with moderate lifting/carrying/pushing) heavy physical activities (lifting/carrying > 25 lbs, sustained effort requiring whole body movements)

HAZMAT Team Activities: Level:

confined space activities (“Permit-Required” or awkward small spaces not usually occupied by man) solitary/isolated duty unusual environmental conditions (excessive heat, cold, humidity, high altitude, etc.)

toxic substances (describe substance(s) for which the respirator is used, and the exposure level, frequency, and duration):

A B C D (as per 29 CFR 1910.120) safety glasses/splash goggles fully encapsulated suit barrier clothing (Tyvek´, etc., coveralls, chemical splash suit) other:

Signature of Requesting Safety Officer or Supervisor Date

Printed Name of Requesting Safety Officer or Supervisor

Phone # with area code

Rev. 04June2020 Page 2 of 3

Request for Respirator Medical Clearance

Agency Name:

Employee Name:

Job Title:

SS#:

Work Phone & Ext:

Best Time to Phone:

Instructions to Safety Officer or Supervisor: Please check all respirators and other applicable items that apply to the employee's job functions, sign and print your name and the date of the request. Forward this form to the servicing examination facility or your clinic's contact person so that a medical evaluation of the employee can be scheduled.

Request for NIOSH-approved respirator:

Frequency of Use:

Duration of Use:

Other Personal Protective Equipment (PPE) to be Used:

Job Functions While the Employee Will be Wearing the Respirator (check all that apply) :

(as per 29 CFR 1910.120)

Rev. 04June2020 Page 2 of 3

11.0.0.20130303.1.892433.887364

TextField1:

TextField2:

TextField3:

TextField4:

TextField5:

TextField6:

CheckBox1: 0

CheckBox2: 0

CheckBox3: 0

CheckBox4: 0

CheckBox5: 0

CheckBox6: 0

CheckBox7: 0

CheckBox8: 0

CheckBox9: 0

CheckBox10: 0

CheckBox11: 0

CheckBox12: 0

TextField7:

CheckBox13: 0

CheckBox14: 0

CheckBox15: 0

CheckBox16: 0

CheckBox17: 0

CheckBox18: 0

CheckBox19: 0

CheckBox20: 0

CheckBox21: 0

CheckBox22: 0

CheckBox23: 0

CheckBox24: 0

CheckBox25: 0

CheckBox26: 0

CheckBox27: 0

CheckBox28: 0

CheckBox29: 0

CheckBox30: 0

CheckBox31: 0

TextField8:

TextField9:

CheckBox32: 0

CheckBox33: 0

CheckBox34: 0

CheckBox35: 0

TextField10:

SignatureField1:

DateField1:

TextField11:

TextField12:

DateTimeStyle1:

DateTimeStyle2:

Additional Immunizations

Hepatitis A

Hepatitis B

Tetanus

Influenza

Company Name

Employee Name Job Title/Position

Work Phone Ext.

Supervisor Name Work Phone Ext.

Occupational Health Physical Exam Supervisor Component Selection Form

Form Instructions:

• This form is to be completed upon hire and/or when an employee's job function(s) significantly changes.

• Please check all applicable items that apply to the employee's job functions.

• Aspects of each exam are described in the Matrix on Page 3 of this form.

• Forward/Return this form to the Occupational Health Clinic so a medical evaluation can be scheduled.

• If your employee requires a respirator, please also fill out and submit the form on page 2.

• Contact the Certified Industrial Hygienist (ext. 3422) or the DHS Environmental Safety & Occupational Health Office

(ext. 3301) with questions.

Date

File Plan: GRS 2.7, Item 060 Rev. Date: 04June2020

Exams Requested

Fitness for Duty Exams Surveillance Exams Biocontainment Entry Clearance Exam Full Exam at time of hire and every 3 years. Interim Health Assessment every year in between.

Respirator Clearance If checked, also complete and return form on page 2.

Fire Brigade Physical Exam Available only for PIADC Fire Brigade Members

Merchant Mariner Exam US Coast Guard Requirement

Asbestos Clearance Exam Employee may be exposed to friable asbestos during the course of their employment.

Emergency Medical Technician Exam Available only for PIADC EMTs/Paramedics

Foreign Pre-Travel Evaluation The Occupational Health Clinic offers individual consultation with the RMO and State Department suggested medications and immunizations for work-related travel abroad. This box should be selected if the employee has the potential to travel outside of the United States during the course of their employment.

Commercial Drivers License (CDL) Exam Department of Transportation Requirement

Serum Banking Required for APHIS Diagnostic Department and/or animal care staff.

Animal Contact Rabies, Tetanus, & Influenza Vaccinations Mandatory (APHIS, ARB) Optional (ARS)

Asbestos Screening Exam This is for employees who have had prior exposures

Other Exposures

Circle: Formaldehyde Lead Cadmium Other

Enrollment in the Hearing Conservation Program See the DHS Hearing Conservation Program Plan, CIH, or DHS ESOH Office if unsure.

Supervisor Signature

Additional Immunizations

Occupational Health Physical Exam Supervisor Component Selection Form

Form Instructions:

This form is to be completed upon hire and/or when an employee's job function(s) significantly changes.Please check all applicable items that apply to the employee's job functions. Aspects of each exam are described in the Matrix on Page 3 of this form.Forward/Return this form to the Occupational Health Clinic so a medical evaluation can be scheduled. If your employee requires a respirator, please also fill out and submit the form on page 2. Contact the Certified Industrial Hygienist (ext. 3422) or the DHS Environmental Safety & Occupational Health Office (ext. 3301) with questions.

File Plan: GRS 2.7, Item 060

Rev. Date: 04June2020

Exams Requested

Fitness for Duty Exams

Surveillance Exams

11.0.0.20130303.1.892433.887364

CheckBox16: 0

CheckBox16: 0

CheckBox16: 0

CheckBox16: 0

TextField1:

TextField2:

TextField3:

TextField4:

TextField5:

DateTimeField1:

CheckBox1: 0

CheckBox2: 0

CheckBox4: 0

CheckBox6: 0

CheckBox6: 0

CheckBox10: 0

CheckBox10: 0

CheckBox11: 0

CheckBox12: 0

CheckBox9: 0

CheckBox8: 0

CheckBox14: 0

CheckBox15: 0

CheckBox5: 0

CheckBox7: 0

Enter Other Exposures for Surveillance or Medical Exams Not Listed:

SignatureField1:

Plum Island

Animal Disease Center

Personnel Reliability Program

June 11, 2021

Personnel Reliability Program

Rev. Date: 11Jun2021 File Plan #: 401-123-001 Page 2 of 27 PIADC Personnel Reliability Program

Revision History

Revision Date Reason for revision 12/09/14 New signature not required. Administrative updates; added Revision History page, added attachment numbers, added “Sample” to each attached form to refer users to the electronic version, saved the document as a .pdf portfolio.

12/10/14 Signature required. Edited form; PDI Disclosure to Medical Reviewing Official

12/12/14 Signature not required. Administrative update to the PDI Disclosure Form with the approval from Dr. Barrett.

12/16/15 Updated formatting. Updated section 5. Responsibilities, Item E. PIADC Select Agent Personnel Reliability Assessment Board. Updated section 11.

Investigation Procedures, Item F. Appeal Process. Updated all four forms;

PIADC Personnel Reliability Program Enrollment Form, PIADC Ongoing Reliability Assessment Form, Potentially Disqualifying Disclosure (PDI) to Medical Reviewing Official, PIADC Interim Notification of PDI.

7/18/16 Revised PRP Enrollment Form and Annual Supervisor Assessment Form.

Omitted the Ongoing Assessment Form. Modified the appeal section. Revised PIADC Pre-Access Reliability Assessment Guide

9/9/16 Removed the requirement for annual NCIC checks for the Ongoing Full Reliability Assessment.

10/9/18 Admin Update to address grammatical errors and restructured for clarity 7/30/20 Editorial changes throughout. Section 5.7 added Federal Officer as a Security

Specialist role. Section 7 added Director of Biorisk Management to 'Entity Leadership', added definition of 'Select Agent Exclusion Areas'. Added Section 8.2.4 which established a 45-day deadline for personnel to complete overdue medical evaluations, or access to biocontainment will be revoked by EO until physical is complete. Updated Attachments E-H. Added Attachments I &J.

6/11/2021 Administrative review.

Rev. Date: 11Jun2021 File Plan #: 401-123-001 Page 3 of 27

Table of Contents

1.0 INTRODUCTION

2.0 POLICY

3.0 PURPOSE

4.0 SCOPE AND AUTHORITY

5.0 RESPONSIBILITIES

6.0 RECORDS

7.0 DEFINITIONS

8.0 PROCEDURES FOR PRE-ACCESS RELIABILITY ASSESSMENT AND ONGOING

MONITORING

9.0 REPORTING

10.0 HOW INFORMATION SHOULD BE REPORTED

11.0 INVESTIGATION PROCEDURES

12.0 TRAINING

13.0 AFTER HOURS ACCESS

14.0 ATTACHMENTS

Attachment A: Table 1: Federal Select Agent Program SRA Clearance Prohibitions and Restric ...23 Attachment B: Table 2: Examples of Reportable Conditions, Behaviors, or Other Information Attachment C: PIADC Guidance for Supervisor Assessment of Personnel for Enrollment into PIADC

PRP (From the Guidance Document for Tier One) Attachment D: PIADC Pre-Access Reliability Assessment Process Attachment E: PIADC PRP Enrollment Form....................................................................See Portfolio Attachment F: PIADC PRP Annual Supervisor Assessment Form ....................................See Portfolio Attachment G: PIADC Potentially Disqualifying Information Disclosure to Medical Reviewing Official

.....................................................................................................................................See Portfolio Attachment H: PIADC Interim Notification of Potentially Disqualifying Information .....See Portfolio Attachment I: PIADC Personnel Reliability Assessment Board Charter ..........................See Portfolio Attachment J: Occupational Health Supervisor Physical Exam Form ..............................See Portfolio

Rev. Date: 11Jun2021 File Plan #: 401-123-001 Page 4 of 27

1.0 INTRODUCTION

The mission of the Plum Island Animal Disease Center (PIADC) is to protect the United States from the accidental or intentional introduction of foreign animal diseases (FADs) that seriously harm livestock industries, food security or the economy. PIADC is a biosafety-level 3 laboratory facility and the only U.S. laboratory that can possess and manipulate foot-and-mouth disease virus (FMDv).

The U.S. Code of Federal Regulations (CFR) 9 Part 121 classifies FMDv as a Tier 1 select agent requiring strict security and personnel reliability procedures. Federal select agent regulations specify the personnel reliability requirements necessary for an individual to access Tier 1 biological select agents and toxins (BSAT). Therefore, a personnel reliability program is required to help ensure the reliability of staff approved for access to Tier 1 select agents at PIADC. The purpose of this personnel reliability plan is to guard Tier 1 BSATs and Tier 1 BSAT security information from misuse by a PIADC insider.

2.0 POLICY

The policy of PIADC is to comply with all federal laws related to the security of the BSAT in the facility. Supervisors will ensure that staff members follow all relevant federal laws, regulations and guidelines associated with the security of BSAT. The PIADC Senior Leadership Group and senior management will provide support to achieve the personnel reliability program requirements stated in this document. The following PIADC policies and procedures are defined in this document:

2.1. Procedures for conducting a pre-access reliability assessment of persons requesting access to a Tier 1 BSAT and Tier 1 BSAT security information.

2.2. Procedures for coordination and communication between PIADC’s responsible official (RO) and PIADC safety and security professionals to ensure the security of Tier 1 BSAT.

2.3. Procedures for the ongoing assessment of the reliability of personnel with access to a Tier 1 BSAT and Tier 1 BSAT security information. These procedures include:

2.3.1. Procedures for self- and peer-reporting of incidents or conditions that could affect a staff member’s ability to safely have access to or work with BSAT or to safeguard BSAT from theft, loss or release;

2.3.2. Training requirements for employees with access to Tier 1 BSAT on PIADC policies and procedures for reporting, evaluation and corrective actions concerning the assessment of personnel reliability;

2.3.3. Procedures for the ongoing reliability monitoring of individuals with access to Tier 1

BSAT;

2.3.4. Procedures that limit access to Tier 1 BSAT and Tier 1 BSAT security information to only individuals who (a) are approved by the Health and Human Services (HHS) Secretary or Administrator, following a security risk assessment (SRA) by the Attorney General of the United States; and (b) who have had an PIADC-led pre-access reliability assessment; and (c) who are in compliance with PIADC’s ongoing reliability assessment program;

Rev. Date: 11Jun2021 File Plan #: 401-123-001 Page 5 of 27

2.3.5. Procedures that limit access to laboratory and storage facilities outside of normal business hours to only personnel specifically approved by the responsible official or designee; and

2.3.6. Procedures for approving visitors, their property and their vehicles to access registered space or other designated points of entry to PIADC buildings, facility or biocompound based on PIADC’s site-specific risk assessment.

2.4. This Personnel Reliability Plan will be reviewed annually and revised as necessary.

3.0 PURPOSE

This document defines the PIADC policies, responsibilities and requirements for verifying the reliability of all persons who have access to Tier 1 BSAT and Tier 1 BSAT security information at PIADC. An ongoing personnel reliability assessment program is required for entities registered for Tier 1 BSAT per 9 CFR 121.11(f) (3), including:

3.1. Mechanisms for self and peer-reporting of behaviors of concern. Specifically, incidents or conditions that could affect an individual’s continued ability to access, or work safely with, Tier 1 BSAT or to safeguard Tier 1 BSAT from theft, loss or release.

3.2. Ongoing monitoring of reliability for individuals with access to Tier 1 BSAT and Tier 1 BSAT security information.

3.3. Training on PIADC policies and procedures for reporting, evaluating and corrective actions concerning personnel reliability for employees with access to Tier 1 BSAT and Tier 1 BSAT

United States 9 CFR 121 requires both pre-access and ongoing reliability assessments to reduce the risk of BSAT misuse by an “insider,” and to ensure that individuals granted access to Tier 1 BSAT continue to merit access. The purpose of the pre-access reliability assessment is to evaluate the fitness, character and conduct of incoming personnel before access to Tier 1 BSAT is granted. Subsequent annual and ongoing whole-person assessments for each individual determine the overall reliability for continued access to Tier 1 BSAT and Tier 1 BSAT security information. A person’s reliability to have access to Tier 1 BSAT is defined as not displaying behaviors determined by PIADC that would increase the risk of a theft, loss or release of BSAT. See 9 CFR 121.10(g) for a list of possible concerning behaviors.

This document defines PIADC’s program to comply with these personnel reliability requirements in coordination with the PIADC Visitor Control and Authorization Policy, PIADC Employee Physical Access Control Policy and the PIADC Security Plan.

4.0 SCOPE AND AUTHORITY

This Personnel Reliability Plan applies to all personnel granted unescorted access to PIADC spaces registered with the Federal Select Agent Program (FSAP), known as select agent exclusion areas, including biocontainment and liquid waste decontamination space (Buildings 101, 102 and 111).

These requirements apply to all PIADC DHS and USDA employees, and to contractors, but not necessarily to escorted visitors (e.g., for the purposes of maintenance, repairs, tours, audits and inspections).

Rev. Date: 11Jun2021 File Plan #: 401-123-001 Page 6 of 27

PIADC is registered and inspected by the U.S. Department of Agriculture (USDA) Select Agent Program under Title 9 CFR Part 121, “Animals and Animal Products: Possession, Use, and Transfer of Select Agents and Toxins” to ensure compliance with all regulations.

Additional authorities and guidance can be found in (a) the PIADC Security Plan, (b) the PIADC Occupational Health Program, (c) the DHS Instruction Handbook 121-01-007 for the Department of Homeland Security Personnel Suitability and Security Program, and (d) The Federal Select Agent Program Suitability Guide (https://www.selectagents.gov/suit-intro.html).

5.0 RESPONSIBILITIES

5.1. Entity Official (EO): The EO is responsible for overall implementation of the PIADC personnel reliability plan. The PIADC Director acts as the EO and has the authority to immediately restrict or deny access to Biocontainment (select agent exclusion areas) based on behavioral, medical or administrative grounds. The Director will:

5.1.1. Designate the Responsible Official (RO) and provide support to the RO in the development and implementation of a reliability assessment program for persons with access to Tier 1 BSAT at PIADC.

5.1.2. Support the RO in the establishment of policies and procedures to execute an effective personnel reliability program. These policies and procedures will include:

5.1.2.1. Routine pre-access and ongoing reliability assessment protocols;

5.1.2.2. Policies that…