ML20154E970
| ML20154E970 | |
| Person / Time | |
|---|---|
| Issue date: | 09/23/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Tefft D NEW HAMPSHIRE, STATE OF |
| Shared Package | |
| ML20154E976 | List: |
| References | |
| NUDOCS 9810090037 | |
| Download: ML20154E970 (10) | |
Text
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.8 Ms. Dians E. Tcfft, Administrator SEP 2 31998 Radiological Health Bureau Division of Public Health Services j
Health and Welfare Building 6 Hazen Drive l
Concord, NH 03301-6527
Dear Ms. Tefft:
We have reviewed the proposed New Hampshire regulations which are contained in Part He-P 4030, Licensing of Radioactive Material; Part He-P 4031, General Licenses; Part He-P 4032, Specific Liconses for Manufacture or Transfer of Certain items Containing Radioactive Material; Part He-P 4033, Specific License of Broad Scope for Other Than Human Use; Part He-P 4034, Radiation Safety Requirements for Industrial Radiographic Operations; and Part He P 4035, Use of Radionuclides in the Healing Arts. The proposed regulations were reviewed by comparison to the equivalent NRC regulations in p CFR Parts 30,31,32,33,34 and 35.
As a result of our review of Parts He-P 4030,4031,4033,4034, and 4035, we have identified 18 comments (see Enclosure 1). As a result of our review of Part He-P 4032, we have identified 13 comments (see Enclosure 2). Because of the large number of comments, we recommend that you conduct a separate review to ensure that Part He-P 4032 is complete prior to your completing this rule in final.
Please note that we are providing Office of State Programs' (OSP) comments, only, on issues that we believe affect the compatibility of your regulations. Our Office of General Counsel did not review your proposed regulations or the OSP comments.
If you have any questions regarding the comments, the compatibility criteria, or any of the NRC regulations used in the review, please contact me or Kevin Hsueh of my staff at 415-2598.
Sinceraly, Ori inalSigned By:
G PAULH.LOHAUS i
Paul H. Lohaus, Deputy Director Office of State Programs
]
Enclosures:
As stated i
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DOCUMENT NAME:
- See previous concurrence.
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OFFICE OSP l
OSP:DD l
OGC / l OSP:D[Q[/
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NAME KHsueh:nb:kk PHLohaus FXCamor6n RLBangart %
DATE 09/21/98*
09/22/98*
06/ /98 09/>3/98 9810090037 900923 OSP FILE CODE: SP-AG-18 PDR STPRG ESGNH l
Ms. Dians E. Tcfft, Administrator Radiological Health Bureau Division of Public Health Services Health and Welfare Building 6 Hazen Drive Concord, NH 03301-6527
Dear Ms. Tefft:
We have reviewed the proposed New Hampshire reguic ions which are contained in Part He-P i
l 4030, Licensing of Radioactive Material; Part He-P 403, General Licenses; Part He-P 4032, j
Specific Licenses for Manufacture or Transfer of Certa' Items Containing Radioactive Material; j
Part He-P 4033, Specific License of Broad Scope for ther Than Human Use; Part He-P 4034, Radiation Safety Requirements for Industrial Radiogr phic Operations; and Part He-P 4035, Use of Radionuclides in the Healing Arts. The propo ed regulations were reviewed by comparison to the equivalent NRC regulations in 10 FR Parts 30,31,32,33,34 and 35.
As a result of our review of parts He-P 4030,4031, 033,4034, and 4035, we have identified 18 comments (see Enclosure 1). Please note that e are only providing our office comments on issues that we believe affect the compatibility o your regulations.
As a result of our review on Part He-P 4032, we h ve identified 13 comments (see Enclosure 2). Because of the large number of comments, e recommend that you conduct a separate review to ensure that this Part is complete prior t your completing this rule in final.
If you have any questions regarding the comm ts, the compatibility criteria, or any of the NRC regulations used in the review, please contact e or Kevin Hsueh of my staff at 415-2598.
S' cerely, i
aul H. Lohaus, Deputy Director l
Office of State Programs l
Enclosures:
As stated l
l l
l l
Distribution:
DlR RF (8S227)
DCD (SP05)
SDroggitis BUsilto.
PDR (YES.f__ NO
)
DWhite, Rl SSalo on New Hampshire File DOCUMENT NAME: G:\\KPH\\NHCOV.WP i
Ta receive a copy of this document, Indicate in the box: 'C' =
thout attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy I
OFFICE OSPeb,
OSR)[$$;s NOGC OSP:D l
NAME KHsueh:nbNN I PHLohaUs I
FXCar'n%rort RLBangart DATE 09/>I /98 09/O /98 09/ /98N 09/ /98 OSP FILE CODE: SP-AG-18
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WASHINGTON. D.C. 2000H001 k9 * * * * *,o' September 23, 1998 Ms. Diane E. Tefft, Administrator Radiological Health Bureau Division of Public Health Services Health and Welfare Building 6 Hazen Drive Concord, NH 03301-6527
Dear Ms. Tefft:
j We have reviewed the proposed New Hampshire regulations which are contained in Part He-P 4030, Licersing of Radioactive Material; Part He-P 4031, General Licenses; Part He-P 4032, Specific Licenses for Manufacture or Transfer of Certain items Containing Radioactive Material; Part He-P 4033, Specific License of Broad Scope for Other Than Human Use: Part He-P 4034, Radiation Safety Requirements for Industrial Radiographic Operations; and Part He-P 4035, j
Use of Radionuclides in the Healing Arts. The proposed regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Parts 30,31,32,33,34 and 35.
As a result of our review of Parts He-P 4030,4031,4033,4034, and 4035, we have identified 18 comments (see Enclosure 1). As a result of our review of Part He-P 4032, we have identified 13 comments (see Enclosure 2). Because of the large number of comments, we recommend that you conduct a separate review to ensure that Part He P 4032 is complete prior to your completing this rule in final.-
Please note that we are providing Office of State Programs' (OSP) comments, only, on issues that we believe affect the compatibility of your regulations. Our Office of General Counsel did not review your proposed regulations or the OSP comments.
If you have any questions regarding the comments, the compatibility criteria, or any of the NRC regulations used in the review, please contact me or Kevin Hsueh of my staff at 415-2598.
S'c ely,
/
ht/-
W Maul H. Lohaus, Deputy Director Office of State Programs
Enclosures:
As stated
l l
l COMMENTS ON PROPOSED NEW HAMPSHIRE REGULATIONS 1
AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Category Reaulation Reaulation Sublect and Comments Part Part 30 Rules of General Applicability to Domestic He-P 4030 Licensing of Byproduct Material A
30.4 Definitions Definitions of " Alert" and " Site area emergency" are omitted and should be adopted to meet the compatibility category.
B 30.13 Carriers Section 30.13 is omitted and should be added to meet the compatibility category.
]
30.34 Terms and conditions of licenses l
C Paragraph 30.34(b) is omitted and should be added to meet compatibility category.
30.50 Reporting requirements C
Paragraphs 30.50 (a), (b) and (c) are omitted and should be added to meet compatibility category.
30.51 Records C
Paragraphs 30.51 (a) and (b) are omitted and should be added to meet compatibility category.
Part Part 31 General Domestic Licenses for Byproduct Material He-P 4031 C
He P 4031.02 31.6 seneral license to install devices generally licensed in 6 31.5 Section 31.6 is omitted and should be added to meet the compatibility category.
Part Part 33 Specific Domestic Licenses of Broad Scope for He-P 4033 Byproduct Material No comments.
. ENCLOSURE 1
State NRC Category Regulation Regulation Subject and Comments Part Part 34 Licenses for industrial Radiography and Radiation L
1 He-P 4034 Safety Requirements for industrial Radiographic Operations l
B He-P 4034.01 34.3 Definitions Definitions of " Certifying Entity" and " Independent Certifying Organization" are omitted and should be adopted to meet the compatibility category.
C He-P 4034.05 34.13 Specific license for industrial radiography Paragraph 34.13 (b) is omitted and should be added to meet the compatibility category.
Paragraph 4034.05 (f) omits from 34.13 (g) "... and potential designees responsible for ensuring that the licensee's radiation safety program is implemented in accordance with approved procedures." This phrase should be adopted to meet the compatibility category.
Paragraph 4034.05 (g) omits from 34.13 (h) "... and the qualifications of the person (s) authorized to do the leak testing. If the applicant intends to analyze its own wipe samples, the application must include a description of the procedures to be followed. The description must include
... This phrase should be adopted to meet the compatibility category.
B He P 4034.06 34.20 Performance requirement for industrial radiography equipment Subparagraph 34.20 (a)(2) is omitted and should be added to meet the compatibility category.
C He-P 4034.12 34.31 Inspection and maintenance of radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments.
Paragraph 4034.12 (c) omits 34.31 (b)(1) "... Replacement components shall meet design specifications..." This should be adopted to meet the compatibility category.
! ENCLOSURE 1
l i
State NRC Category Regulation Reaulation Sublect and Comments B
He-P 4034.17 34.43 Training Subparagraph 4034.17 (a) (1) omits 34.43 (a) (1) "... and is certified through a radiographer certification program by a certifying entity in accordance with the criteria specified in appendix A of this part." This should be adopted to -
meet the compatibility category.
Paragraph 4034.17 (g) omit 34.43 (f) "... certification documents,..." This should be adopted to meet the compatibility category.
C-He-P 4034.32 34.79 Records of training and certification Paragraph 4034.32 (a) omits 34.79 (a) "... radiographer certification documents and verification of certification status,..." This should be adopted to meet the compatibility category.
Part Part 35 Medical Use of Byproduct Material He-P 4035 H&S He-P 4035.19 35.53 Measurement of dosages of unsealed byproduct material for medical use Paragraph 4035.19 (a) adds in 35.53(a)"...that contains more than 370 kilobecquerels (10 Cl)..." The addition should be omitted.
H&S He P 4035.21 35.59 Requirement for possession of sealed sources and brachytherapy sources.
Subparagraphs 4035.21(e)(8), (i)(7) and (m)(5) "The signature of the individual who performed the test" should be changed to "The signature of the Radiation Safety Officer."
l l
l c ENCLOSURE 1 7
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l l
l State NRC
. Category Regulation Regulation Sublect and Comments He-P 4035.25 35.75 Release of individuals containing radiopharmaceuticals or l
permanent implants.
1 C
He-P 4035.25 35.75(a) l H&S He-P 4035.25 35.75(b) i We recommend that the new paragraphs 35.75 (a) and (b), which have been effective since 5/29/97, be adopted.
The State should adopt thesa paragraphs no later than May 29,2000.
! ENCLOSURE 1
COMMENTS ON PROPOSED NEW HAMPSHIRE REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC Cateaory Regulation Reaulation Sublect and Comments Part Part 32 Specific Domestic Licenses to Manufacture or He-P 4032 Transfer Certain items Containing Byproduct Material B
32.2 Definitions.
Definition of " Lot Tolerance Percent Defective" is omitted and should be adopted to meet the compatibility category.
C 32.13 Introduction of byproduct materialin exempt concentrations into products or materials, and transfer of ownership or possession: Prohibition of introduction.
Section 32.13 is omitted and should be added to meet the compatibility category.
B 32.17 Resins containing scandium-46 and designed for sand-consolidation in oil wells: Requirement for license to manufacture, or initially transfer for sale or distribution.
Section 32.17 is omitted and should be added to meet the I
compatibility category.
NRC 4032.10(a) 32.21 Radioactive drug: Manufacture, preparation, or transfer and (b) for commercial distribution of capsules containing carbon-14 urea each for "in vivo" diagnostic use for humans to persons exempt from licensing: Requirements for a license.
Paragraph 4032.10(a) and (b), which are equivalent to section 32.21, contains NRC program elements of regulation. The State should not adopt this section of the regulation.
B 32.57 Calibration or reference sources Am-241: Requirements for license to manufacture or initially transfer.
Section 32.57 is omitted and should be added to meet the compatibility category.
l ENCLOSURE 2
State NRC Category Regulation Regulation Subject and Comments l
B 32.58 Same: Labeling of device.
'Section 32.58 is omitted and should be added to meet the compatibility category.
B 32.59 Same: Leak testing of each source.
Section 32.59 is omitted and should be added to meet the compatibility category.
B 32.61 Ice detection devices containing strontium-90:
Requirements for license to manufacturer or initially transfer.
l Section 32.61 is cmitted and should be added to meet the compatibility category.
B 32.62 Same: Quality assurance; prohibition of transfer, i
Section 32.62 is omitted and should be added to meet the i
compatibility category.
B 32.71 Manufacture and distribution of byproduct material for j
certain in vitro clinical or laboratory testing under general license.
Section 32.71 is omitted and should be added to meet the compatibility category.
B 32.102 Schedule C-prototype tests for calibration or reference sources containing americium 241.
l l
Section 32.102 is omitted and should be added to meet j
the compatibility category.
t B
-32.103 Schedule D-prototype tests for ice detection devices containing strontium 90.
Section 32.103 is omitted and should be added to meet the compatibility category, l
B 32.110 Acceptance sampling procedures under certain specific licenses.
Section 32.110 is omitted and should be added to meet the compatibility category.
]
, ENCLOSURE 2 i
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TASK # - 8S227 DATE- 08/19/98 w
MAIL CTRL. - 1998 T3K STARTED - 08/19/98 TASK DUE - 09/22/98 TASK COMPLETED -
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TASK DESCRIPTION - REVIEW NEW HAMPSHIRE REGULATIONS
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