ML23047A277

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FOIA-2023-000058 - Resp 1 - Final
ML23047A277
Person / Time
Issue date: 02/07/2023
From: Karen Danoff
NRC/OCIO/GEMSD/FLICB
To: Beck R
- No Known Affiliation
References
FOIA-2023-000058
Download: ML23047A277 (1)


Text

NRC FORM 464 Part I U.S. NUCLEAR REGULATORY COMMISSION FOIA or Reference Number Response Number (01-26-2023)

RESPONSE TO FREEDOM OF FOIA-2023-000058 1 INFORMATION ACT (FOIA) REQUEST Response Type Interim Final Requester: Date:

Rhys Beck 02/07/2023 Description of Requested Records:

Any documentation relating to the deaths caused by the Therac-25 radiation therapy machine produced by AECL.

PART I. -- INFORMATION RELEASED The NRC has made some, or all, of the requested records publicly available through one or more of the following means:

(1) https://www.nrc.gov ; (2) public ADAMS, https://www.nrc.gov/reading-rm/adams.html; (3) microfiche available in the NRC Public Document Room; or the NRC Public Access Link (PAL), at https://foia.nrc-gateway.gov/app/Home.aspx.

Agency records subject to the request are enclosed.

Records subject to the request that contain information originated by or of interest to another Federal agency have been referred to that agency (See Part I.D -- Comments) for a disclosure determination and direct response to you.

We are continuing to process your request.

See Part I.D -- Comments.

PART I.A -- FEES You will be billed by NRC for the amount indicated. Since the minimum fee threshold was not met, AMOUNT you will not be charged fees.

You will receive a refund for the amount indicated.

Due to our delayed response, you will not be Fees waived. charged search and/or duplication fees that would otherwise be applicable to your request.

PART I.B -- INFORMATION NOT LOCATED OR WITHHELD FROM DISCLOSURE We did not locate any agency records responsive to your request. Note: Agencies may treat three discrete categories of law enforcement and national security records as not subject to the FOIA ("exclusions"). See 5 U.S.C. 552(c). This is a standard notification given to all requesters; it should not be taken to mean that any excluded records do, or do not, exist.

We have withheld certain information pursuant to the FOIA exemptions described, and for the reasons stated, in Part II.

Because this is an interim response to your request, you may not appeal at this time. We will notify you of your right to appeal any of the responses we have issued in response to your request when we issue our final determination.

You may appeal this final determination within 90 calendar days of the date of this response. If you submit an appeal by mail, address it to the FOIA Officer, at U.S. Nuclear Regulatory Commission, Mail Stop T-6 A60M, Washington, D.C. 20555-0001. You may submit an appeal by email to FOIA.resource@nrc.gov. You may fax an appeal to (301) 415-5130. Please be sure to include on your submission that it is a FOIA Appeal. You may file an appeal through the NRC Public Access Link (PAL) at https://foia.nrc-gateway.gov/app/Home.aspx.

PART I.C -- REFERENCES AND POINTS OF CONTACT You have the right to seek assistance from the NRC's FOIA Public Liaison by submitting your inquiry at https://www.nrc.gov/reading-rm/

foia/contact-foia.html, or by calling the FOIA Public Liaison at (301) 415-0717.

If we have denied your request, you have the right to seek dispute resolution services from the NRC's Public Liaison or the Office of Government Information Services (OGIS). To seek dispute resolution services from OGIS, you may email OGIS at ogis@nara.gov, send a fax to (202) 741-5789, or send a letter to: Office of Government Information Services, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001. For additional information about OGIS, please visit the OGIS website at https://www.archives.gov/ogis.

NRC FORM 464 Part I U.S. NUCLEAR REGULATORY COMMISSION FOIA or Reference Number Response Number (01-26-2023)

RESPONSE TO FREEDOM OF FOIA-2023-000058 1 INFORMATION ACT (FOIA) REQUEST Response Type Interim Final PART I.D -- COMMENTS The FOIA Office received your request on January 13, 2023, and tasked the Office of International Programs (OIP), Office of Nuclear Regulatory Research (RES), Office of the Secretary to the Commission (SECY), and the Office of Nuclear Material Safety and Safeguards (NMSS) to search for any responsive records.

OIP, RES, and SECY located no responsive records. NMSS staff informed us that the NRC does not regulate machine-produced radiation; the Food & Drug Administration (FDA) investigated the overexposures and deaths related to these devices. If you have not already done so, you may wish to submit a FOIA request to the FDA. Here is a link to FDA's FOIA webpage: https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request.

Nonetheless, NMSS conducted a search of the Agencywide Document Access and Management System (ADAMS), which is the NRC's official recordkeeping repository, for any records that touch upon the subject matter of your request. They identified the following records that are publicly available in ADAMS in the Main Library (ML):

ML20118A251 ML20102A780 ML20086T304 ML20070N298 ML20057D006 ML20035B671 ML19327B119 ML003774110 ML020310357 ML15119A064 ML20127H497 ML081550571 ML072410234 ML13073A879 In addition, NMSS staff identified the following Training-related records that mention Therac-25, which are maintained in ADAMS in the Licensing Support Network (LSN) Library:

DN2002218418 DEN001265687 DEN001273099 DN2002086363 DEN001285370 DN2002012836 DEN001287245 All of these records are publicly available in the NRC's Public Electronic Reading Room at http:www.nrc.gov/reading-rm.html. If you need assistance in obtaining these records, please contact the NRC's Public Document Room (PDR) at 301-415-4737, or 1-800-397-4209, or by email to PDR.Resource@nrc.gov.

Signature - Freedom of Information Act Officer or Designee Karen E. Danoff Digitally signed by Karen E. Danoff Date: 2023.02.07 10:59:47 -05'00'