ML032200267

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Deficiency Letter to Met One Instruments Dated 6/13/03
ML032200267
Person / Time
Issue date: 06/13/2003
From: Bhachu U
NRC/NMSS/IMNS
To: Siebert R
Met One Instruments
References
SSD 03-17
Download: ML032200267 (3)


Text

June 13, 2003 Ron Siebert Met One Instruments 1600 Washington Blvd.

Grants Pass, OR 97526

Dear Mr. Siebert:

This letter is in reference to your application dated February 11, 2003, requesting an amendment to NRC Certificates NR-1124-D-101-E and NR-1124-D-102-E, and electronic mail correspondence dated June 5, 2003, and June 9, 2003, regarding the use of calibration sources in Met One Models BAM-1020 and E-BAM detector devices. In order to complete our review, please refer to the Enclosure for background information and additional information required.

We will continue our review upon receipt of this information. If we do not receive a response from you in 30 days, we will consider your request as having been abandoned and void the active control for your request. This action would be without prejudice to the resubmission of another request.

If you have any questions, please contact me at (301) 415-7894, or John Jankovich at 301-415-7904.

Sincerely,

/RA/

Ujagar S. Bhachu, C Eng., P Eng., Fl Mech E Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosure:

As Stated

June 13, 2003 Ron Siebert Met One Instruments 1600 Washington Blvd.

Grants Pass, OR 97526

Dear Mr. Siebert:

This letter is in reference to your application dated February 11, 2003, requesting an amendment to NRC Certificates NR-1124-D-101-E and NR-1124-D-102-E, and electronic mail correspondence dated June 5, 2003, and June 9, 2003, regarding the use of calibration sources in Met One Models BAM-1020 and E-BAM detector devices. In order to complete our review, please refer to the Enclosure for background information and additional information required.

We will continue our review upon receipt of this information. If we do not receive a response from you in 30 days, we will consider your request as having been abandoned and void the active control for your request. This action would be without prejudice to the resubmission of another request.

If you have any questions, please contact me at (301) 415-7894, or John Jankovich at 301-415-7904.

Sincerely,

/RA/

Ujagar S. Bhachu, C Eng., P Eng., Fl Mech E Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

Enclosure:

As Stated Distribution:

NMSS13 SSD 03-17 File Name: K:\\Document Processing Center_Ascent\\ADAMSP8-2039\\downloads\\101 - 200\\110\\ML032200267.wpd To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy OFFICE MSIB MSIB MSIB NAME NAshkeboussi JJankovich UBhachu DATE 6 / 13 /2003 6 / 13 /2003 6 / 13 /2003 OFFICIAL RECORD COPY

SSD Case 03-17: Met One Instruments 6/13/03 Met One Instruments, by a letter dated February 11, 2003, requested the use of Canberra calibration sealed sources in Models BAM-1020 and E-BAM aerosol detector devices. Met One is proposing to use the Canberra calibration sealed sources for another purpose than their intended use and function; i.e, Met One intends to install these calibration sources into an aerosol detector device to monitor air pollution. The source Models C14-60 and C14-100, for which Met One Instrument is seeking NRC authorization for use in these devices, have not been evaluated for this purpose.

In addition, the Model C14-100 contains an activity level of 100 microcurries which is in excess of 75 microcurries maximum limit currently stated in the Met One sealed source and device registration certificates requiring new safety evaluation.

Specific requirements, applicable to Met One's devices, that must be addressed during the product evaluation with the Canberra sources are listed below:

Area to be Addressed Applicable 10 CFR Regulations Design 30.20(a), 32.26(b)

Maximum Radiation Levels 32.26(b)(6)

Maximum Dose Commitments 32.26(b)(13) & (14)

Labeling 32.29(b)

These regulatory requirements apply to the Met One products. Therefore, the product evaluation review considers the design integrity of the radioactive source in the product as a complete unit.

In summary, NRC needs a complete application from Met One regarding the design, containment, shielding, quality control, prototype testing and labeling related to the two aerosol detectors with both models of the Canberra sources in each of your models. Please address these subjects with a narrative and technical description, provide test data or the results of engineering analyses for prototype testing and maximum radiation levels. In preparing your response, you may use the NRC guidance available in NUREG-1556 Volume 3 (available at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/). Specifically, please note Section 10 in the guidance which lists each subject areas that NRC reviews in the safety evaluation. In your response, please provide the information that is applicable to your product as Section 10 delineates the technical content in each of the subject areas.

Enclosure