- What documents should you submit to the DOE Headquarters Certifying Official?
Submit your QAAP Compliance Matrix, QA Program Description (QAPD), and implementing documents to the DOE Packaging QA Lead if you participate in the design, fabrication, procurement, use, or maintenance of Type B or fissile radioactive material packagings certified by DOE, or if you're a DOE/DOE Contractor and ship packages certified by NRC. Your QA Program must satisfy the requirements of 10 CFR 71 Subpart H and be approved and auditied by the DOE Headquarters Certifiying Official as required by DOE Order 460.1C. However, if your QA Program has been approved by NRC, DOE will accept NRC Form 311 and the approval letter from NRC as evidence of compliance with the the Order in lieu of the matrix and implementing documents referenced in the matrix. If your QA Program has been approved by the NNSA Certifying Official for Subpart H, DOE will accept the NNSA Certifying Official's approval documentation as evidence of compliance with the Order in lieu of the matrix and implementing documents referenced in the matrix.
- Where do you send these documents?
Mail your compliance documentation (1 paper copy and 1 CD/DVD or flash drive in pdf) to each address listed below:
Dr. James Shuler
U.S. Department of Energy, EM-4.24
c/o L.F. Gelder
Savannah River Research Campus
227 Gateway Drive, Rm 310
Aiken, SC 29803
Argonne National Lab
c/o Roberta Riel
9700 S. Cass Ave., Bldg. 221
Argonne, IL 60439-4844
- Can DOE/DOE Contractors ship Type B or fissile material in DOE or NRC certified packages, or participate in the design, fabrication, procurement, use, or maintenance of DOE certified packagings if their QAPD has not been conditionally approved or fully approved by the DOE-HCO?
No, you are not in-compliance with DOE Order 460.1C. Contact Dr. Shuler to discuss your particular situation.
- While my QA Program description (QAPD) is under review by the DOE Packaging Certification QA Review Team, what is the status of my "Conditional Approval."?
Your QAPD "Conditional Approval" status remains in effect until your QAPD is approved by the DOE-HCO, or is revoked by memorandum/letter issued from the DOE-PCP QA Lead or DOE-HCO. The status of QAPDs are posted on RAMPAC at QA Docket Status
- Question from DOE/NNSA Contractor - DOE Order O 460.1C is not clear as to who should approve my 10 CFR 71 Subpart H Quality Assurance Program (QAP) for Type B or fissile radioactive material packages?
If you participate in the "design, fabrication, procurement, use, or maintenance..." of a Type B or fissile RAM package certified by DOE, DOT, or NRC then you must have a QAP approved by the DOE Headquarters Certifying Official (HCO). For weapons packages, the National Nuclear Security Administration would approve your QAP.
The HCO issues Quality Assurance Program Approvals based on a.) An audit performed by staff or b.) endorsement of a QAP approved by NNSA or NRC. This arrangement (endorsement) recognizes the roles of the various federal organizations and the associated sensitivities, that is, under normal circumstances, NRC doesn't perform Subpart H audits of DOE, DOE doesn't audit NNSA, and NNSA doesn't audit DOE.
The bottom line is that if a DOE/NNSA Contractor wants to use (or continue to use) a Type B or fissile package certified by DOE, DOT, or NRC, then you need to request HCO approval or renewal of your QAP, and then, after the QAP Approval is issued, you would register with the DOE to become a user of the DOE, DOT, or NRC package of interest. Click here for registration information.
- Question from DOE/SC - Can my contractor make "non-intent" (i.e.,administrative) changes to supplement a QAP approved by HCO, in lieu of a QAP revision and document submittal?
No. The term "non-intent" or "administrative" changes can be interpreted quite differently from one organization to the next. Although NRC allows such changes per §71.106(b), DOE has experienced many contractors with an acceptable Quality Assurance Program (QAP) at the time their QAP was approved, only to witness a severe decline in compliance within a few years later; therefore, DOE entities/contractors must continue to notify the DOE PCP of any changes to the QAP, prior to implementing the proposed changes, and submit the changes for HCO approval. DOE PCP will also continue its practice of issuing QAP approvals for 5-years, despite the change (see Final Rule FR Vol 80, No. 113/Friday June 12, 2015) to NRC's practice to issue their Form 311 without an expiration date.