Clarification of use of manufacturer's pretest data

Letter to All Respirator Manufacturers

Issue Date: January 09, 2006

From: Heinz W. Ahlers, Chief, Technology Evaluation Branch, National Personal Protective Technology Laboratory

Subject: Clarification of use of manufacturer's pretest data

Mr. Dale Pfriem
ICS Laboratories, Inc.
1072 Industrial Parkway, North
Brunswick, OH 44212

Dear Mr. Pfriem:

There is some confusion regarding the NPPTL staff response to a question concerning the use of manufacturer's pretest data.

At the manufacturer's meeting on December 12, Peter Cooper of TVI/CAPA, asked a question regarding the use of manufacturer's pretest data as a substitute for NIOSH certification testing. TVI/CAPA, Mr. Cooper noted TVI/CAPA uses ICS Laboratories (ICS), an accredited contract laboratory, to perform its pretests.

NPPTL staff replied that pretest data could not be used as a substitute for certification testing. Certification testing by NPPTL is required by Title 42 Code of Federal Regulations Part 84. NPPTL staff further elaborated that currently there is lack of a correlation program between NPPTL and sources of manufacturers' pretest data that would preclude using this data as a substitute for certification testing. NPPTL staff noted that a formal round robin correlation testing program, fundamental to third party certification programs, would need to be exercised by NPPTL and this has not been done.

NPPTL intended the above response to apply generally to the use of pretest data as a substitute for certification data. NPPTL is not aware of any lack of reliability of manufacturers' pretest data in general. Further, there is no lack of reliability of pretest data submitted by ICS in particular.

We understand that ICS has and continues to conduct and substantiate round robin correlation testing as part of ISO 17025 accreditation. However, NPPTL has not conducted any evaluation of the correlation of pretest data from any source with NPPTL certification testing data.

Clarification of use of manufacturer's pretest data [PDF - 32 KB]