Title: NPPTL Respirator Certification Program Decision Review Revision: 1.0 Process 

Date: 30 January 2008 

Approved bY~ 

National Personal Protective Technology Laboratory (NPPTL) 

(1) Purpose: To establish a formal, structured process that will enable stakeholders to request a 

review of decisions regarding NPPTL policy statements, test procedures, and test results 

pertaining to ongoing respirator certification activities. This Decision Review Process is 

intended to be used only after normal remediation efforts have taken place and a written decision 

has been rendered. Implementation of this process is intended to improve the quality of 

respirator certification activities by allowing the voice of the customer to be heard during an 

independent review of the decision. Implementation of the process will also serve to improve the 

Laboratory's relationship with its customers by providing a formal pathway to provide feedback 

on rendered decisions. 

(2) Decision Review Process: There are two levels to the Decision Review Process. 

Levell Decision Review is with the Technology Evaluation Branch (TEB). Level 2 Decision 

Review is with the NPPTL Office of the Director. Level 1 Decision Review must be completed 

prior to use of Level 2 Decision Review. 

(3) Decision Review Request (DRR): The DRR is a letter transmittal from the requestor. It 

can be submitted bye-mail or regular mail. The Levell DRR must be postmarked or e-mailed 

within 30 calendar days of the issuance of a written program policy statement or program 

decision. It must be addressed to the TEB Branch Chief. The transmittal is to be clearly 

identified as a "Decision Review Request, Levell" and must identify the program policy 

statement or program decision and the date of the action that is the subject of the request. Only 

the manufacturer or representative submitting the application or written request for policy 

clarification may contend a written decision. 

A Level 2 DRR must be e-mailed or postmarked within 15 calendar days of the issuance of a 

Levell DRR notification (See Section (4 d)). The transmittal is to be clearly identified as a 

"Decision Review Request, Level 2" and must identify the program policy statement or program 

decision and the date of the Levell DRR notification that is the subject of the request. It must 

be addressed to the NPPTL Director. 

The DRR must state the rationale for contending that, for example: a decision regarding an 

NPPTL program policy statement, test procedure, or test result is flawed. The basis for 

reconsideration must be clearly and fully articulated in the DRR. 

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NPPTL Respirator Certification Program Decision Review Process Page 1 of 5 
(4) Level 1 DRR, Decision Making Process: 

(a) Level 1 DRR, Responsible Officials: The Branch Chief for the NPPTL Technology 

Evaluation Branch (TEB) is the responsible official for reviewing Level 1 Decision 

Review Requests (DRRs) and making the final decision on the request. The TEB Branch 

Chief may convene a Technical Review Panel to assist in the review. 

(b) Level 1 DRR, Technical Review Panel: The TEB Branch Chief may, at his/her 

discretion, convene a Technical Review Panel to analyze the DRR and the original 

decision documents, and prepare a written recommendation to the TEB Branch Chief on 

whether to deny or uphold the request. The evidence to be considered in the Technical 

Review Panel’s deliberation is strictly limited to that provided in the documents at hand. 

It is not within the scope of the Technical Review Panel’s charge to conduct any 

additional investigation or inquiry in the matter. 

(c) Level 1 DRR, Technical Review Panel’s Role: The Technical Review Panel’s role 

is advisory in nature. The TEB Branch Chief has full responsibility for the decision and 

may choose not to follow the Review Panel’s recommendation. 

(d) Level 1 DRR, Notification: The Level 1 DRR requestor will be notified of the 

results of the review via a letter signed by the TEB Branch Chief. The letter will state the 

basis for the determination issued. 

(5) Level 2 DRR, Decision Making Process: 

(a) Level 2 DRR, Responsible Officials: The Director of NPPTL is the responsible 

official for reviewing Level 2 Decision Review Requests (DRRs) and making the final 

decision on the request. The Director may convene an Advisory Review Panel to assist 

in the review and to develop a recommended determination. 

(b) Level 2 DRR, Advisory Review Panel: If the Level 2 DRR contains substantial 

evidence, the Director may, at his/her discretion, convene the Advisory Review Panel, 

assign it responsibility for analyzing the DRR and the original decision documents, and 

preparing a written recommendation to the Director on whether to deny or uphold the 

request. The evidence to be considered in the Advisory Review Panel’s deliberation is 

strictly limited to that provided in the documents at hand, i.e., the Level 1 DRR and the 

decision documents, which will be provided to the Advisory Review Panel by the TEB 

Branch Chief. It is not within the scope of the Advisory Review Panel’s charge to 

conduct any additional investigation or inquiry in the matter. 

(c) Level 2 DRR, Advisory Review Panel’s Role: The Advisory Review Panel’s role 

is advisory in nature. The Director has full responsibility for the decision. 

NPPTL Respirator Certification Program Decision Review Process Page 2 of 5 
(d) Level 2 DRR, Notification: The DRR requestor will be notified of the results of the 

Level 2 DRR review via a letter signed by the NPPTL Director. The letter will state the 

basis for the determination issued. 

(6) Follow-up Action: 

The follow-up action for all DRRs shall be the listing of the request, response letter and resultant 

final program statement on the NPPTL webpage. All the documentation pertaining to the DRR 

shall be retained by NPPTL. 

NPPTL Respirator Certification Program Decision Review Process Page 3 of 5 
 

NPPTL Respirator Certification Program Decision Review Process 

Decision Review Request (DRR) Level 1 

Written Decision 

Review Request 

(DRR) Level 1 is 

received by TEB 

Branch Chief 

End Process 

Adequate 

Evidence 

? 

TEB Branch Chief 

convenes Technical Review 

Panel 

Yes 

(Within 30 calendar days of policy 

statement or program decision) 

TEB Branch Chief makes 

final decision regarding DRR 

Convene 

a 

Technical 

Review 

Panel? 

No 

No 

Yes 

(Within 10 calendar days) 

Panel transmits 

recommendation to TEB 

Branch Chief 

TEB Branch 

Chief accepts 

recommendation 

? 

Yes 

No 

TEB Branch Chief 

makes alternate 

determination 

TEB Branch Chief 

notifies requestor of final 

determination and basis 

in writing 

Follow-up Actions: Response 

letter, Web posting, 

Documentum repository, 

Program Area 

reconsideration. 

NPPTL Respirator Certification Program Decision Review Process Page 4 of 5 
 

NPPTL Respirator Certification Program Decision Review Process 

Decision Review Request (DRR) Level 2 

Written Decision 

Review Request 

(DRR) Level 2 is 

received by 

Laboratory 

Director 

Director makes final 

decision regarding 

DRR 

Director convenes 

Advisory Review Panel 

Page 5 of 5 

Yes 

(Postmarked within 15 calendar days of 

issuance of Level 1 DRR notification) 

Convene 

an 

Advisory 

Review 

Panel? 

No 

No 

Yes 

Adequate 

Evidence 

? 

End Process 

(Within 10 calendar days) 

Panel transmits 

recommendation to 

Director 

Director accepts 

recommendation 

? 

Yes 

No 

Director makes 

alternate 

determination Director notifies 

requestor of final 

determination and 

basis in writing 

Follow-up Actions: 

Response letter, Web 

posting, Documentum 

repository, Program Area 

reconsideration. 

NPPTL Respirator Certification Program Decision Review Process