ML20149G572
| ML20149G572 | |
| Person / Time | |
|---|---|
| Issue date: | 10/18/1994 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Bangart R, Bernero R, Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20149G577 | List: |
| References | |
| NUDOCS 9410240042 | |
| Download: ML20149G572 (3) | |
Text
,
[ MG(/
.,k UNITED STATES f~
E NUCLEAR REGULATORY COMMISSION
^
f WASHINGTON, D.C. 20655 0001 l
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October 18, 1994
)
MEMORANDUM T0:
Hugh L. Thompson, Jr.
Deputy Executive Director for Nuclear Materials Safety, Safeguards, and Operations Support Richard L. Bangart, Director Office of State Programs Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards Karen D. Cyr, General Counsel Edward L. Jordan, Director Office for Analysis and Evaluation of Operational Data
'3 FROM:
Paul H. Lohaus, Deputy Directo
[
Office of State Programs
/
SUBJECT:
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW 0F NEW HAMPSHIRE RADIATION CONTROL PROGRAM This memorandum transmits to the Management Review Board (MRB) a proposed final report (Attachment 1) documenting the IMPEP review of the New Hampshire Radiation Control Program.
The review of the New Hampshire program was conducted by an interoffice team during the period August 15-19, 1994.
The team issued a draft report to New Hampshire on September 23, 1994 for factual comment. New Hampshire's factual comments, received by letter dated October 12, 1994 from Dr. Russel C. Jones, Medical Director, New Hampshire Division of Public Health Services (Attachment 2), have been incorporated into the proposed final report with the exception of the comment to prioritize the team's recommendations.
This item is on the agenda for discussion by the MRB.
The review team found the State's performance with respect to the five performance indicators to be satisfactory.
Based on those indicators the review team recommends that the MRB find the New Hampshire program to be adequate to protect public health and safety.
However, a finding that the program is compatible with the NRC's regulatory program should be withheld because the State has not adopted regulations equivalent to the following NRC regulations:
" Emergency Planning Rule," which was needed by April 7,1993;
" Standards for Protection Against Radiation," which was needed by January 1, 1994; and " Safety Requirements for Radiographic Equipment," which was needed by January 10, 1994.
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The MRB meeting to consider the New Hampshire report is scheduled for 1
Thursday, October 27, 1994, from 1:00 to 3:00 p.m. in Room 0-16-B-11.
The agenda for that meeting is attached (Attachment 3).
If you have any questions prior to the meeting, please contact me at 504-2310
)
or Kathleen Schneider at 504-2320.
Attachments:
As stated 1
cc:
Diane Tefft, NH Dennis O'Dowd, NH i
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DIR RF RLBangart PLohaus KSchneider GPangburn SMoore JHornor, RIV/WC SCollins, RIV CHehl, RI JPStohr, RII CGordon, RI GDeegan Guy Arlotto, NMSS Carl Paperiello, NMSS Utah-f He Ayte Ih*pda < OC-IMPEP File DCD (SP01),PDR YES x NO
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007 I 8 1994 2
The MRB meeting to consider the New Hampshire report is scheduled for Thursday, October 27, 1994, from 1:00 to 3:00 p.m. in Room 0-16-B-11.
The agenda for that meeting is attached (Attachment 3).
If you have any questions prior to the meeting, please contact me at 504-2310 or Kathleen Schneider at 504-2320.
Attachments:
As stated cc:
Diane Tefft, NH Dennis O'Dowd, NH 1
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW 0F THE NEW HAMPSHIRE AGREEMENT STATE PROGRAM August 15-19, 1994 1
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Office of State Programs U.S. Nuclear Regulatory Commission
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1.0 INTRODUCTION
This report presents the results of the review of the New Hampshire radiation control program conducted by an interoffice team from the Offices of State Programs (OSP) and Nuclear Material Safety and Safeguards (NMSS).
The State of New Hampshire volunteered to participate in the pilot Integrated Materials Performance Evaluation Program (IMPEP); the information contained in this report was gathered during the routine Agreement State review which was conducted on August 15-19, 1994, covering the period from June 5, 1992, l
through August 19, 1994. The IMPEP common performance indicators were reviewed in accordance with Commission direction contained in a Staff Requirements Memorandum of March 16, 1994. The preliminary results of the IMPEP review were discussed with Dr. Russell Jones, Medical Director, Division of Public Health Services; the radiation control program director (RCPD),
Diane Tefft, Administrator, Bureau of Radiological Health; and other Division managers.
Members of the review team for the New Hampshire review are listed i
in Appendix A.
The Division of Public Health Services is authorized by statute as the State's radiation control agency.
The radiation control program (RCP) is administered by the Bureau of Radiological Health (BRH) and within the Bureau, the Radioactive Materials Section.
The State's organization charts are shown in Appendix B.
New Hampshire is one of the smaller Agreement States, with 99 specific licenses.
In addition to the radioactive materials section, the radiation control program has sections devoted to radiation machine registrations and inspections, radon, radiochemistry and emergency response.
This review focused on the licensing and compliance functions carried out under the Section 274b agreement between New Hampshire and the Commission.
Section 2.0 below is reserved for the status of items identified in previous program reviews.
In this case, all but one of the previous comments were outside the common performance indicators of the IMPEP pilot program.
The previous routine review was conducted in June 1992, according to the
" Guidelines for NRC Review of Agreement State Radiation Control Programs,"
published in the Federal Reaister on May 28, 1992, as an NRC Policy Statement.
This review resulted in a decision to withhold adequacy and compatibility, primarily because of the backlog of overdue inspections (which would be considered under the common performance indicators) and the State's failure to adopt compatible regulations within the 3-year allowable time frame.
During a follow-up review conducted in July 1993, satisfactory action had been taken in all but three indicators, and the finding of adequacy was restored.
The 1993 review resulted in comments relative to two Category I indicators: 5 ta tu:: and Compatibility of Regulations and Enforcement Procedures.
The review team concluded that problems in these indicators have not been satisfactorily resolved.
The current status of these two Category I indicators and the remaining Category II indicator is addressed separately in the routine Agreement State review report.
The results of the New Hampshire review relative to the common performance indicators of the IMPEP are presented in Section 3.0 below.
Section 4.0 discusses the review of those aspects of the New Hampshire program which are outside the common performance indicators, and Section 5.0 summarizes the review team's findings and recommendations.
)
1
New Hampshire - Proposed Final Report Page 2 2.0 STATUS OF ITEMS IDENTIFIED IN THE 1993 NEW HAMPSHIRE AGREEMENT STATE PROGRAM REVIEW RESERVED 3.0 COMMON PE.RFORMANCE INDICATORS The IMPEP is based on five common performance indicators to be used in the review of both regional and Agreement State programs.
These indicators include:
- 1) Status of Materials Inspection Program; 2) Technical Staffing and Training; 3) Technical Quality of Licensing Actions; 4) Technical Quality of Inspections; and 5) Response to Incidents and Allegations.
In preparation for the review the NRC asked the State on April 27, 1994 to complete a questionnaire pertaining to the normal Agreement State indicators. A copy of the New Hampshire response is included as Appendix C to this report.
The review team's general approach for conduct of this review consisted of:
- 1) examination of New Hampshire' response to the questionnaire; 2) review of selected quantitative information from the State's licensing and inspection data base; 3) technical review of selected files; and 4) interviews with staff and management to answer questions or clarify issues raised by 1), 2) and
- 3) above. A member of the team also conducted an accompaniment of a New Hampshire BRH inspector. The team evaluated the information that it gathered against the performance criteria contained in draft Management Directive 5.6 and made a preliminary assessment of the State's performance in each indicator. As noted above, that preliminary assessment was discussed with program management before the team's departure.
3.1 Status of Materials Inspection Proaram The review team examined the State's questionnaire responses relative to this indicator and reviewed data gathered independently from computer printouts, quarterly inspection plans and inspection files.
In addition, the review team interviewed the radioactive materials section supervisor and other technical staff to clarify issues raised by the team's review.
The review team compared the inspection frequencies utilized by the State and those contained in the NRC Inspection Manual Chapter (IMC) 2800. New Hampshire licenses are placed into one of three inspection priorities: I (every year), II (every 2 years) and III (every 4 years).
In general, the assignment of those priorities to the various classes of licenses results in inspection frequencies which are the same or more frequent than NRC's.
However, the team noted two departures from this general observation.
With respect to initial inspections of new licenser, NRC requires that new licenses in priorities I-V be inspected within 6 months of license issuance.
BRH inspects new licenses at 4 months, 8 months or 12 months after license issuance for licenses in priorities I, II and III, respectively.
While this results in a shorter interval for those licenses in priority I--a relatively
1 New Hampshire - Proposed Final Report Page 3 small number of the State's license population--the interval for new licenses in priorities II and III is longer than that contained in IMC 2800.
The review team recommends that the State revise its inspection priorities for initial inspections of new licenses to be consistent with NRC's.
Secondly, the State's inspection frequency for fixed site radiography as listed in their inspection procedures call for inspections every 2 years, whereas IMC 2800 requires that fixed site radiographers be inspected annually.
New Hampshire has only one fixed-site radiographer, however, and its inspection frequency as listed in the licensing data base is yearly.
The review team recommends that the State revise its inspection priorities to conform to their current practice of annual inspection.
s The materials section supervisor develops an inspection plan on a quarterly basis. The routine program of inspection according to BRH's frequencies requires approximately 39 inspections to be done each year. At the time of the review, there was no backlog of overdue inspections; only one. inspection was overdue and it was scheduled to be inspected in September 1994.
With respect to initial inspections of new licenses, the review team examined 13 new licenses issued during the review period and compared the date of the initial inspection against the criteria contained in IMC 2800 which requires such inspections to be conducted within 6 months of license issuance. Of those, seven licenses were inspected within 6 months of license issuance, two were determined to not have received radioactive material and four licenses were inspected more than 6 months after license issuance.
Review of a sample of 13 inspection cases indicated that inspection findings (10 of 13) were issued within 30 days of the inspection.
In two cases, the letters were 1 and 2 months late, respectively.
Review of a third case indicated that the enforcement letter for an inspection conducted on August 31, 1993, had not been issued as of the.date of the review. This matter was discussed with the materials section supervisor who acknowledged that his review was the source of the delay in this case and indicated that it would be issued promptly.
Based upon the evaluation criteria in draft Management Directive 5.6, tne review team concluded that BRH's performance relative to this indicator was satisfactory.
3.2 Technical Staffinu and Trainina I
The review team reviewed the State's response to the questionnaire, interviewed the materials section supervisor, and met with members of the technical staff on staffing and training issues, BRH is subdivided into five sections: Radioactive Materials, Radiation 4
Machines, Radon, Radiochemistry and Emergency Response.
Each section head reports directly to the RCPD.
Personnel in Radioactive Materials and I
New Hampshire - Proposed Final leport Page 4 Radiation Machines exchange duties on a monthly basis; i.e., a health physicist will do radioactive material licensing and inspection for a month, shift over to do x-ray registration and inspection for a month, and then return to radioactive materials. This assures that staff cre up to date in these major program areas and minimizes the potential impact of any staff departures, which can be critical in such a small program.
The RCP has four Health Physicist-I (HP-I) personnel who apply 0.35 FTE each to the radioactive materials program as well as 1 HP-II who applies 0.9 FTE for a total of 2.3 FTE. The number of staff appears to be adequate to cover routine and most non-routine demands of the program.
Staff turnover has been minimal during the review period; in fact, the program has grown substantially since the last formal review. One individual in the radioactive materials l
program was promoted to a supervisory position outside the radioactive l
matM a orogram and one individual in the emergency response section i
ret-1 The vacancy resulting from the promotion was filled and, in
- additio, two new HP-I positions were created and filled.
The emergency response position was in the process of interviews at the time of the review l
and was expected to be filled in the August-September time frame.
Salaries l
for professional and managerial personnel are generally lower than those for similar employment in adjacent States, but this has not had an apparent effect on the Bureau's ability to attract and retain personnel. Morale and job satisfaction among the technical staff was quite good.
All technical staff have at least a Bachelor's degree in the physical or life sciences and have taken the NRC's 5-week Applied Health Physics course.
Position descriptions exist for all positions and are appropriate for the i
duties required.
Staff are in various stages of completion of NRC core courses and have taken a variety of courses outside of the core courses l
including Radiological Emergency Response Operation training, transportation, and Part 20 training.
Review of the courses taken and discussions with staff and management demonstrated a strong management commitment to training and development of staff.
Based on the evaluation criteria in draft Management Directive 5.6, the review team concluded that BRH's performance relative to this indicator was satis factory.
3.3 Technical Quality of Licensina Actions The State issued 14 new licenses and 32 renewals in entirety, and processed 24 i
terminations during the review period.
In addition, 142 amendments and 209 simple renewals were issued.
Eight license files were selected for casework review including two new licenses, one amendment, three renewals in entirety
(
and two license terminations. All license reviewers were included in the
(
review.
License types included one fixed gauge, two portable gauges, one sealed irradiator, three R&D labs, and one service license. A list of these licenses with case-specific comments can be found in Appendix D.
New Hampshire - Proposed Final Report Page 5 The licensing actions were reviewed for completeness, consistency, proper isotopes and quantities, qualifications of authorized users, adequate facilities, operating and emergency procedures, and authorized user training sufficient to establish the basis for the licensing action. Casework was reviewed for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of the basis for the licensing decision, and consideration of enforcement history on renewals.
The files were checked for orderliness and retention of necessary documents and supporting data.
The file reviews indicated the quality of the licenses was very good, and there were only isolated comments, with no generic problems. All supporting documents were available.
The deficiency letters were well-drafted and thorough.
The license conditions were consistent with those used by the NRC.
Unsatisfactory responses from the licensees were resolved and the results documented.
It was noted the State performs pre-licensing inspections and delivers new licenses in person if the reviewer feels it would be of benefit.
Because licenses in New Hampshire are only valid for 1 year, simple renewals are issued annually.
Every 5 years, each license is renewed in its entirety, 1
and the licensee must submit a new application and supporting' documents.
The State uses NRC regulatory guides and standard review forms supplemented by their own forms, guides, check sheets, and policy memoranda.
In reviewing these documents, the team found that the State has produced at least 18 new or revised procedures, regulatory guides, review forms, or similar documents i
since the last routine review.
New Hampshire statutes require that licensa conditions and regulatory guides be published in the form of regulations.
)
Because rule adoption is normally a lengthy process, licensing circumstances that are not covered by the standard conditions are handled either by internal policy or by requiring the licensee to furnish commitments that can be included in the tie-down condition.
i The team noted that the new review forms and checklists are well written and provide appropriate guidance to license reviewers. The termination check-list, in particular, is excellent.
l Based on the evaluation criteria in draft Management Directive 5.6, the review team concluded that BRH's performance relative to this indicator was satisfactory.
3.4 Technical Ouality of Insoections The review team reviewed the State's inspection procedures and forms, and reviewed the inspection reports and follow-up documentation for nine materials inspections conducted during the review period.
The cases covered a range of medical, academic, and industrial licensees and reflected the work of all four BRH inspectors. Appendix E provides a list of the inspection cases reviewed.
The team discussed the results of this review in interviews with three
New Hampshire - Proposed Final Report Page 6 inspectors and the materials section supervisor.
In addition, a team member accompanied an inspector on an inspection in Manchester, New Hampshire, of a portable gauge licensee.
During the accompaniment, the inspector demonstrated appropriate inspection technique and knowledge of the New Hampshire regulations. The inspector was prepared for the inspection and conducted the inspection in a very thorough manner. The inspector demonstrated competence with health physics practices.
He also demonstrated a good grasp of the safety issues involving the licensee, and he focused inspection effort on those areas. The inspection was executed well.
The technical performance of the inspector was satisfactory, and his inspection was adequate to assess radiological health and safety at the licensed facility.
Three of the four materials inspectors have been accompanied by their supervisor so far during 1994.
Records indicate that in 1993 two of the inspectors were accompanied for audit purposes, and discussions with the staff indicated that new inspectors were accompanied for training purposes. The supervisor's goal is to accompany inspectors at least once during each year.
The review team determined through discussions with staff, review of New Hampshire's compliance manual, and a review of the inspection files that BRH has inspection procedures in place and that inspectors are following the guidance in those procedures.
However, a review of the general procedures found that inspection procedures do not cover some elements inherent to the inspection program, including exit interviews at the conclusion of an inspection and oral debriefings with the inspection supervisor following a non-routine inspection.
In addition, the chapters of the compliance manual covering specific types of licensees need to be updated to conform with recent New Hampshire rule changes. Although the actual inspections did not demonstrate problems in these areas, the review team recommends that the inspection procedures be revised to include all essential elements of the inspection and to conform to State regulations.
Although exit meetings are not covered in the procedures, the review team determined that materials inspectors were attempting to hold exit meetings at the conclusion of an inspection with the highest level of licensee management available.
The review team also determined through interviews with the inspectors that oral debriefings are held informally with the supervisor of the Radioactive Materials Section after the inspector returns from an inspection trip.
On the nine inspection cases reviewed, the reviewer found that the inspection reports were generally well documented. Documentation of independent measurements made by the inspectors was included in most of the reports.
Seven of the reports consisted of the inspectors' written comments on inspection forms. The remaining two reports were narrative, typed reports.
BRH regarded both narrative reports as describing routine inspections.
Actually, one inspection of a portable gauge licensee was a special inspection
0 New Hampshire - Proposed Final Report Page 7 in follow-up to a series of. phone calls associated with the licensee. The inspection closed some special issues, in addition-to reviewing the licensee's routine radiation safety program. The other. narrative report was for an initial inspection of New Hampshire's only large, dry-storage irradiator.
Both narrative reports were intended to cover the full inspections, and in general, narrative reports are acceptable for these types of inspections.
However, the review team noted that these two narrative reports did not include the full range 'of issues that would have been documented on the inspection forms.
If narrative reports are to be used for routine inspections, the team recommends that the narrative report cover each of the items covered in the inspection forms.
For special inspections, the narrative report need not be so comprehensive.
While reviewing the inspection reports, the review team found that several different versions of inspection forms (field notes) had been used over the.
review period. Although different inspection forms are appropriately used for different types of licensees, BRH also had several different sets of inspection forms for the same or similar type licensees.
In addition, the review team noted that some sets of inspection forms are missing sections that should have been inspected.
For instance, a medical licensee inspection report had no indication on the inspection forms that the licensee's postings and leak tests were inspected. These-areas were omitted from the inspection forms.
Interviews with inspectors and the section supervisor revealed that.
BRH has been updating their inspection forms, which led to the different sets of inspection forms over the review period. The review team recommends that the State review, update, and standardize the inspection forms used for l
different categories.of licensees'.
The review team observed that BRH has developed a form that is used by inspectors to evaluate licensee responses to notices of violations (NOVs).
The inspector's review of the licensee's response, as. evidenced by these forms, appears to be quite thorough. The review team noted that of the nine inspection cases reviewed, BRH requested further follow-up, beyond the initial NOV response, in.two cases. This demonstrates that New Hampshire is effectively reviewing licensee responses to NOVs, and when the licensee's first response is not sufficient, BRH requests an additional response to resolve the outstanding issue.
l Of the nine inspection reports reviewed, the section supervisor had signed off.
on seven reports, six in advance of dispatching.the inspection results and one i
afterwards.
Of the remaining two cases, the section supervisor was a co-signer on one of the reports, and in the last case, the report had not yet.
4_
been issued.
The review team noticed a healthy dialogue between the section supervisor and inspection staff, as evidenced by the section supervisor's-i handwritten notes on the inspection reports.
The review team determined that i
the section supervisor is performing a thorough review of inspection reports.
i In the area of confirmatory measurements and independent measurements, the-review team determined that inspectors were performing sufficient independent k
i l
New Hampshire - Proposed Final Report Page 8 measurements.
Independent measurements were being documented in the field notes and narrative inspection reports, in most cases. However, the reviewer found that in six of the nine cases reviewed, the report was missing information or only had partial information on the survey instrument used by the inspector to perform independent and confirmatory measurements.
Specifically, the model, serial number, and calibration date were missing in whole or in part on six reports. The review team recommends that this information be included on each inspection report.
During the inspection accompaniment and in discussions with inspectors, the review team determined that inspectors do not use standard check source readings for response checks on their radiation detection instruments, although standard sources are available.
During the accompaniment, the inspector said that he had checked the instrument for operability against a known " hot spot" on BRH's calibration source, and another inspector indicated that he knew of this practice. However, from a health physics perspective, it is preferable to compare the instrument's reading with a known reading from standard check source in a given geometry prior to each use.
The review team recommends that BRH perform instrument response checks against known reference check sources on radiation detection equipment used on inspections.
The review team discussed the equipment calibration procedures with the laboratory staff, and found that New Hampshire sends their radiation detection equipment to the State of South Carolina for calibration.
The review team examined the documentation that South Carolina returns with the calibrated survey meters and found that the survey meters were being calibrated adequately.
The review team also verified the instruments are calibrated within the interval required by inspected licensees.
In summary, the review team developed iso uted comments from the casework reviews, and these comments were not indicative of any generic issues or problems, beyond those identified above.
The reviewer's comments were discussed with the supervisor of the Radioactive Materials Section and with the inspectors during the review.
Based on the evaluation criteria contained in draft Management Directive 5.6, the review team concluded that BRH's performance relative to this indicator is satisfactory.
3.5 Response to Incidents and Alleaations Fourteen incidents or allegations were reported to the State in the 22-month reporting period. The two incidents requiring NRC notification were properly reported, and the 1993 Annual Event Summary was sent to the NRC on April 28, 1994.
There we e no misadministrations involving therapy.
In the five files selected for in-depth review, the State had taken prompt, appropriate action.
Investigations were thorough and well-documented.
These cases are discussed in Appendix F.
The section supervisor is in the process of revising the incident reporting forms and tracking system.
New Hampshire - Proposed Final Report Page 9 The State's revised emergency response plan, "DPHS Initiator Handbook," was reviewed on June 15, 1994. The radioactive materials section is sufficient to provide guidance for responding to incidents and allegations involving radioactive materials, including transportation incidents.
It was determined through interviews that BRH personnel qualified as incident responders are given refresher training.
-Based on the evaluation criteria in draft Management Directive 5.6, the review team concluded that BRH's performance relative to this indicator was satisfactory.
4.0 NON-COMMON PERFORMANCE INDICATORS In addition to the common performance indicators addressed in Section 3.0 above, the review team also examined New Hampshire' performance relative to other indicators found in the Commission's 1992 policy statement.
Those indicators for which the review team had recommendations are listed below.
4.1 Status and Comoatibility of Reaulations The New Hampshire regulations were compared with latest chronology of NRC regulation amendments that are needed for compatibility.
The State's regulations are compatible through the " Decommissioning Rule." The State has not adopted rules equivalent to the following NRC rules:
" Emergency Planning Rule," which was needed by April 7, 1993; " Standards for Protection Against Radiation," which was needed by January 1, 1994; and " Safety Requirements for Radiographic Equipment," which was needed by January 10, 1994.
The New Hampshire program historically has been unable to maintain regulations compatible with those of the NRC within the 3-year time frame.
In an effort to determine the reasons for the ongoing problem and to explore possible solutions, the NRC team examined the State's rule prescribing the rulemaking procedures, reviewed action dates for rules currently in the promulgation process, reviewed the Bureau's responses to the latest objections offered by the rules committee pertaining to the State's equivalent rule to the new Part 20, and held detailed interviews with management and staff of the Division of Public Health Services.
The team believes the primary reasor, for the delays can be traced to the State's rules dictating the rulemaking process. The "New Hampshire Rulemaking-Manual" (Ls-A 2-93), published by *he Division of Administrative Rules of the Office of Legislative Services, must be followed by any State Agency writing rules. Thus, the same Administrative Rules designed for issuing driver's licenses, fishing licenses, etc., apply to the rules governing licenses issued for the use of radioactive materials.
These rulemaking rules are so restrictive that they do not lend themselves well to complex, scientific licensing activities.
For example:
.. ~
New Hampshire - Proposed Final Report Page 10 Each rule expires exactly 6 years after it is enacted and must be resubmitted in"its entirety to remain in effect.
Any guidance or directives, such as license conditions, regulatory guides, inspection priorities, and severity levels for enforcement actions, must be published in the form of rules.
The permitted wording is extremely confining.
Rules cannot include footnotes, appendices, or anything explanatory.
Formulas must be written in such a manner that including a complex formula is not possible.
Tables must be simple and numbered sequentially throughout the chapter (entire radiation rule volume) which essentially requires that the tables be renumbered after each additional rule change.
The 6-year sunset clause, in effect, prevents the certainty of long term control of radioactive material.
The review team recommends the State take steps to accelerate the promulgation process in order to maintain regulations compatible with the NRC's. One mechanism that could be considered would be proposing legislation to exempt the radiation control program from the administrative rulemaking procedures.
4.2 Leoal Assistance Availability of legal assistance is a problem for the Bureau.
The small size of the RCP within the overall structure of State government makes it difficult to obtain attention from the Attorney General's office on routine legal matters.
Requests for legal assistance from the Attorney General are sent through the Legal Coordinator in the Division of Public Health.
Because of the number of requests for legal review sent to this individual from the Bureau, as well as other Offices within the Division, prompt legal assistance has been problematic.
Cases in point include review of Part 20 equivalent regulations (approximately 11 months for legal review) as well as review of well-logging regulations (also 11 months for legal review).
The review team recommends that the Division of Public Health take appropriate steps to assure that the radiation control program has prompt legal assistance available when needed.
4.3 Enforcement Procedures The State uses the 1990 draft procedures, which are modeled after Appendix C of 10 CFR Part 2, to guide the enforcement process. However, as noted in the previous section, the Division must publish regulations to implement the authority to assess civil penalties and establish severity levels for enforcement actions.
Review of a sample of 13 inspection cases where notices of violation were issued to licensees indicated that most enforcement letters (10 of 13) were i
I
t New Hampshire - Proposed Final Report Page 11 issued within 30 days of the inspection.
In two cases, the letters were 1 and 2 months late, respectively. Review of a third case indicated that the enforcement letter for an inspection conducted on August 31, 1993, had not been issued as of the date of the review. This matter was discussed with the section supervisor who acknowledged that his review was the source of the delay in this case and indicated that it would be issued promptly.
Enforcement letters were clear with respect to violations and uniformly cited the license condition or regulation being violated as well as both the actions required and the time frame for the licensee to respond.
Licensee responses were promptly reviewed by the inspector, using a standard form that is reviewed by the section supervisor, and promptly acknowledged in writing to the licensee, i
The review team recommends that BRH adopt the rule necessary to implement the provisions for severity levels and civil penalties that are now in draft form.
BRH plans to submit a rule package to the legal coordinator in late 1994 which
{
contains changes to its radioactive materials regulations to bring these into conformity with the revised Part 20 equivalent regulations. We suggest that i
BRH consider including the revised inspection and enforcement procedures, with
{
the provisions for severity levels and civil penalties, as part of that
]
package, rather than waiting to submit the rule separately.
5.0
SUMMARY
As noted in Section 3 above, the review team found the State's performance with respect to each of the performance indicators to be satisfactory.
1 Accordingly, the team recommends the Management Review Board find the New l
Hampshire program to be adequate to protect public health and safety.
l However, a finding that the program is compatible with NRC's regulatory program should be withheld because the State has not adopted rules equivalent l
to the following NRC rules:
" Emergency Planning Rule," which was needed by i
April 7,1993; " Standards for Protection Against Radiation," which was needed by January 1, 1994; and " Safety Requirements for Radiographic Equipment,"
which was needed by January 10, 1994.
)
l The team also provides the following summary list of recommendations, as
)
mentioned previously in earlier parts of the report, for action by the State.
l 1.
The review team recommends that BRH revise its inspection priorities for initial inspections of new licenses to be consistent with NRC's (see page 3).
2.
The review team recommends that BRH revise its inspection priorities to conform to their current practice of annual inspection (see page 3).
)
1 3.
The review team recommends that the inspection procedures be revised to I
include all essential elements of the inspection and to conform to BRH l
regulations (see page 6).
l 1
l
New Hampshire - Proposed Final Report Page 12 4.-
lhe review team recommends that the BRH narrative reports used for routine inspections cover each of the essential elements covered in the inspection forms (see page 7).
5.
The review team recommends that BRH review, update, and standardize the-inspection forms used for different categories of licensees (see page 7).
6.
The review team recommends that the model, serial number, and calibration date of survey instruments used during BRH inspections be included on each inspection report (see page 8).
7.
The review team recommends that BRH inspectors perform instrument response checks against known reference check sources on radiation-detection equipment used on inspections (see page 8).
8.
The review team recommends the Division of Public Health take steps to accelerate the promulgation process in order to maintain regulations compatible with the NRC's (see page 10).
9.
The review team recommends that the Division of Public Health take appropriate steps to assure that the radiation control program has prompt legal assistance available when needed (see page 10).
10.
The review team recommends that BRH adopt the rule necessary to implement the provisions for_ severity levels and civil penalties that are now in draft form (see page 11) 1 l
i
+
l l
APPENDIX A New Hamoshire IMPEP Team Members Name Area of Responsibility Jack Hornor, RIV/WCF0 Team Leader Technical Quality of Licensing Incidents and Allegations Scott Moore, NMSS/IM08 Technical Quality of Inspections George Pangburn, NMSS/IM08 Technical Staffing and Training Status of Materials Inspection Program
APPENDIX B ORGANIZATION CHARTS i
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APPENDIX C EVALVATION OF AGREEMENT STATE RADIATION CONTROL PROGRAM PART I PROGRAM GUIDELINES AND STATE QUESTIONNAIRE UPDATE Name of State Program: New Hampshire Reporting Period: June 1992 to August 1994 I.
LEGISLATION AND REGULATIONS A.
Leoal Authority (Category I)
NRC Guidelines: Clear statutory authority should exist, designating a State radiation control agency and providing for promulgation of regulations, licensing, inspection and enforcement.
States regulating uranium or thorium recovery and associated wastes pursuant to the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA) must have statutes enacted to establish clear authority for the State to carry out the requirements of UMTRCA.
States regulating the disposal of low-level radioactive waste in permanent disposal facilities must have statutes that provide authority for the issuance of regulations for low-level waste management and disposal. The statutes should also provide regulatory program authority and provide for a system of checks to demonstrate that conflicts of interest between the regulatory function and the developmental and operational functions shall not occur.
(The level of separation (e.g., separate agencies) should be determined for each State individually.
In selecting this level, each State should have a system of checks to demonstrate that conflicts of interest between the regulatory function and developmental and operational functions will not occur.)
Questions:
1.
What changes were made to the State's statutory authority to regulate agreement materials, low level waste disposal, or l
uranium mill operations in the reporting period?
l
- None j
4 2.
Are your regulations subject to a " sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
- Yes, every 6 years.
It varies, each rule adopted has its own 6 year life.
New Hampshire C-2 B.
Status and Compatibility of Requlations (Category I)
NRC Guidelines: The State must have regulations essentially identical to 10 CFR Part 19, Part 20 (radiation dose standards, effluent limits, waste manifest rule and certain other parts),
Part 61 (technical definitions and requirements, performance objectives, financial assurances) and those required by UMTRCA, as implemented by Part 40. The State should adopt other regulations to maintain a high degree of uniformity with NRC regulations.
For those regulations deemed a matter of compatibility by NRC, State regulations should be amended as soon as practicable but no later than 3 years. The RCP should have established procedures for effecting appropriate amendments to State regulations in a timely manner, normally within 3 years of adoption by NRC. Opportunity should be provided for the public to comment on proposed regulation changes (required by UMTRCA for uranium mill regulation.)
Pursuant to the terms of the Agreement, opportunity should be provided for the NRC to comment on draft changes in State regulations.
Questions:
What is the effective date of the last compatibihity-related 1.
amendment to the State's regulations 7
- 12/20/93 Decommissioning Rule 2.
Referring to the latest NRC chronology of amendments, identify those that have not been adopted by the State, explain why they were not adopted, and discuss actions being taken to adopt them.
Rule NRC RULE A/S RULE NH PREDICTED EFFECTIVE DUE DATE DATE & STATUS Emergency Plan
- 4/7/90 4/7/93 6/95; in draft form Safety Requirements for IR*
1/10/91 1/10/94 6/95; in draft form Part 20 6/20/91 6/20/94 10/94; Draft in 6th revision Incident Notification 10/15/91 10/14/94 6/95; No action QM 1/27/92 1/27/95 6/25; No Action
- Internal licensing procedures are in place to ensure licensees adhere to provisions in these rules.
It is extremely difficult to change regulations in NH.
First, the New Hampshire rules dictating the rulemaking
New Hampshire C-3 process are extremely prescriptive and are not geared toward governing complex ;cientific endeavors such as radiation control.
Second, each NH rule expires exactly six years after enactment and must be resubmitted. Third, each fea change, reg guide and license condition must be published, also with a six-year expiration date.
The current process is so extensive that -it requires the equivalent of one FTE just to keep up with changes in the NRC rules, reg guides, and license conditions.
Each time NRC makes a change, the NH program must start an extensive promulgation effort.
For example, the process of changing the State's equivalent of 10 CFR 20 began in January 1993, and now has a target date of October 1994 because of the numerous objections and additional rewrites-primarily due to the Administrative Rules Committee objections.
3.
Identify the person responsible for-developing new or amended regulations affecting agreement materials.
- Diane Tefft, Administrator, has primary responsibility but all staff in rad. material and X-ray sections are involved.
II.
ORGANIZATION Under the Appendix B title sheet provided at the end of this document, please enclose copies of your organization charts as follows:
a) organization chart (s) showing the position of the radiation control program (RCP) within the State organization and its relationship-to the Governor, other State and local RCPs (if any), and comparable health and safety programs.
b)
RCP internal organization charts.
If applicable, include regional offices and contract agencies.
All charts should be current, dated, and include names and titles for all positions.
- See Appendix B.
A.
Location of the Radiation Control Proaram Within the State Oraanization (Cateaory II)
NRC Guidelines:
The RCP should be located in a State organization parallel with comparable health and safety programs.
The Program Director should have access to appropriate levels of State management. Where regulatory responsibilities are divided between State agencies, clear understandings should exist as to division of responsibilities and requirements for coordination.
New Hampshire C-4 Questions:
1.
During the reporting period, did the management, program name, or location of the RCP within the State organization change?
- No B.
Internal Oraanization of the RCP (Category II)
NRC Guidelines:
The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the execution of program policy. Where regional offices or other government agencies are utilized, the lines of communication and administrative control between these offices and the central office (Program Director) should be clearly drawn to provide uniformity in licensing and inspection policies, procedures aad supervision.
1 Questions:
1.
What changes occurred in the organization of the RCP during the reporting period?
- Several staff changes as follows:
- Wayne Johnston was promoted to Supervisor, Radiation Machine Section (HP II).
10/9/92
- Wayne's former HP I position was filled on 1/22/93 by Kathy McAllister.
- Two new HP I positions were created and filled by Mario Iannaccone - 6/12/92 and Deborah Russell - 8/21/92.
- A new Laboratory Scientist III - Radiochemist position I
was created, funded and filled by Twila Kenna on 4/1/94.
This position is for other than utility associated duties (e.g., licensee close out surveys, environmental monitoring, analysis of inspection wipes, instrument calibration, etc.)
2.
If changes occurred, how have they affected the RCP and its effectiveness?
i
- These individuals are all undergoing training at various stages.
The HP's train in both rad material and X-ray.
I
s New Hampshire C-5 C.
Leaal Assistance-(Category II)
NRC Guidelines:
Legal staff should be assigned to assist the RCP or procedures should exist to obtain legal assistance expeditiously. Legal staff should be knowledgeable regarding the RCP program, statutes, and regulations.
Questions:
1.
If legal assistance was utilized during the reporting period, briefly describe the circumstances.
- Not specifically, other than rule making.
2.
Was the legal assistance satisfactory during this period?
If not, what were the problems?
- The overall problem is that the Attorney General's Office is becoming less and less available for the types of questions / problems the BRH has (e.g., collection of $60 for an unregistered X-ray machine).
Instead our discussions are with Public Health's legal coordinator who is our pass through to the AG's office.
D.
Technical Advisory Committees (Category II)
NRC Guidelines: Technical Committees,. Federal Agencies, and other resource organizations should be used to extend staff capabilities for unique or technically complex problems.
A State Medical Advisory Committee should be used to provide broad guidance on the uses of radioactive drugs in or on humans.
The Committee should represent a, wide spectrum of medical disciplines.
The Committee should advise'the RCP on policy matters and regulations related to use of radioisotopes in or on humans.
Procedures should be developed to avoid conflict of interest, even. though Committees are advisory. This does not mean that representatives of the regulated community should not serve on advisory committees or not be used as consultants.
Questions:
l.
Please list the names, affiliations, and terms of the technical committee (s) members.
Diane Tefft serves as Technical Secretary of the State Radiation Advisory Committee.
The names of the Committee members are as follows:
New Hampshire C-6 NAME AFFILIATION / SPECIALTY TERM EXPIRES Kenneth DeHart, Jr., M.D.
Lakes Region General 10/14/95 Hospital (Medicine)
Dr. Richard Fralick Plymouth State College 10/14/97 (Life Science)
David C. Frost, D.M.D.
Private Practice 10/14/97 (Dentistry)
Rep. Philip Lobombarde (Industry) 10/14/94 C.G Leutzinger, M.D.
Elliot Hospital (Medicine) 10/14/94 James P. Tarzia, CHP North Atlantic Energy 10/14/97 Services Corporation (Physical Science)
Kenneth E. Mayo, P.E.
(Industry) 10/14/95 Robert Normandin, Ph.D.
(Life Science) 10/14/94 Rep. Charles Vogler (Physical Science) 10/14/95 2.
If an advisory committee or consultant was used during the reporting period, briefly describe each circumstance -(i.e.,
the subject, the need, the result, and the manner obtained -
by meeting, phone call, or letter).
- Recently a member of the Committee was asked to review a calculation presented in an application to be used for instrument calibration.
- Also, asked for opinions in " supervision" for medical licensees.
l
- We also frequently discuss current topics with Committee members.
- Provided assistance in the evaluation of adequacy of training and experience for a proposed authorized user physician amendment request for a medical use. license.
E.
Contractual Assistance (Category II)
NRC Guidelines:
Because of the diversity and complexity of low-level radioactive waste disposal licensing and regulation, States regulating the disposal of low-level radioactive waste in permanent disposal facilities should have procedures and mechanisms in place for acquisition of technical and vendor services necessary to support these functions that are not otherwise available within the RCP.
The RCP should avoid the selection of contractors which have been selected to provide 4
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'New Hampshire C-7 services associated with the LLW facility development or operations.
i 1
- Not applicable, j
i III. MANAGEMENT AND ADMINIS1 RATION l
l A.
Ruality of Emeraency Plannina (Category I)
NRC Guidelines: The State RCP should have a written plan for i
response to such incidents as spills, overexposures, transportation accidents, fire or explosion, theft, etc. The Plan should define the responsibilities and actions to be taken by State Agencies. The Plan should be specific as to persons responsible for initiating response actions, conducting operations q
and cleanup.
Emergency communication procedures should be adequately established with appropriate local, county and State agencies.
Plans should be distributed to appropriate persons and agencies.
NRC should be provided the opportunity to comment on the Plan while in draft form. The plan should be reviewed annually by Program staff for adequacy and to determine that l
content is current.
Periodic drills should be performed to test 1
the plan.
l Questions:
1.
Other than the communications list, when was the emergency plan last revised?
)
1 l
- The New Hampshire P.cdiological Emergency Response Plan (NHRERP) was revised in June of 1994.
r
- The Portsmouth Naval Shipyard Plan (PNS) was last updated July 1993.
- The Radiological Incident Plan (RIP) was last reviewed and revised in the summer of 1993.
The earlier version was dated 12/30/87.
2.
If the plan was revised since the last review, what changes were made?
- Forms have been updated.
Lessons learned from exercises and drills have been applied. We have moved closer to a single plan and set of procedures for both VY and SS.
EPA 400 was incorporated.
- The RIP was completely re-organized and re-drafted.
- An Initiator's Book was developed to guide early actions j
regardless of the type of radiological emergency.
l l
N E
New Hampshire C-8 3.
If the plan was substantially revised during the reporting period, was the NRC provided the opportunity to comment on the revision while it was in draft form?
- The NHRERP was completely reprinted as Revision 7 and.
forwarded to FEMA for their review and approval. Their exercise reports generate many of the changes. The NRC was not asked to comment.
4.
When was the emergency communication list last reviewed or revised?
- The emergency communication list, the " phone book," is updated and re-printed quarterly by the Office of Emergency Management.
It is a complete listing of response organizations and members. The most recent version is dated June 1994.
- The Initiator Book is updated as needed; the most recent updating took place June 29, 1994.
5.
When and how was the plan last tested?
- Every year N.H. has a full FEMA evaluated exercise for either VY (April 1993) or SS (December 1994) that is preceded by a dress rehearsal, a combined functional drill and specific skill. training activities.
The RCP also participates in the VY and SS yearly NRC exercises.
The next VY NRC rehearsal will be August 19, 1994.
B.
Budaet (Category II)
NRC Guidelines: Operating funds should be sufficient to support program needs such as staff travel necessary to conduct an effective compliance program, including routine inspections, follow-up or special inspections (including pre-licensing visits) and responses to incidents and other emergencies, instrumentation and other equipment to support the RCP,' administrative costs in operatir.g the program including rental charges, printing costs, 1aboratory services, computer and/or word processing support, preparation of correspondence, office equipment, hearing costs, etc., as appropriate.
States regulating the disposal of low-level radioactive _ waste facilities should have adequate budgetary resources to allow for changes in funding needs during the LLW facility life cycle.
After appropriations, the sources of program funding should be stable and protected from competition from or invasion by other State programs.
Principal operating funds should be from sources which provide continuity and reliability, i.e., general tax, license fees, etc. Supplemental T.mds may be obtained through contracts, cash grants, etc.
-New'Hampsh' ire C-9 4
Questions:
21.-
Show the amount for funds for'the RCP for the current fiscal
~
year obtained from:
a.
State general fund
- $221,172 b.
Fees
- $140,000 I
c.
Federal grants and contracts (identify)
- FDA-HCFA mammography grant - $38,782
- EPA-State Indoor Radon Grant yr. 5 - $157,631
- FOA-MQSA (Mammography Quality Standards Act) $40,807 Proposal submitted 7/8/94 d.
Other.
- Utility funds - $426,907 e.
Bureau Total (FY. 95 budgeted)
- $959,982 2.
Show the total amounts in the current RCP budget allocated for the following (if contract costs are incurred, e.g, in LLW regulation, please include):
a.
Administration
- $52,454 b.
Radioactive materials
- $235,584 c.
X-ray
- $239,023 l
d.
Environmental surveillance l
- (Radiochemistry) $137,162 e.
Emergency planning
- $197,380 f.
LLW regulation (regulation only, do not include site i
development) i b
New Hampshire C-10
- $2,766 g.
U-mill regulation
- None h.
Other (radon, non-ionizing, operator credentialing, etc.
Please identify).
- Radon total - $315,262 (0 50% matching funds) 1.
Total:
Equals total budgeted funds
- FY 95 - $959,982 3.
What percentage of your radioactive materials program is supported by fees?
- Total fees - $140,000 (Approximately $105,000 X-ray and
$35,000 rad materials)
Fees fund about 31% of the combined Rad material /X-ray programs.
4.
Discuss any changes in program funding that occurred during the reporting period, the reasons for the changes (new programs, change in emphasis, statewide reduction, fee cost recovery percentage, etc.), and how the changes affected the program.
- In FY 94 an increase in required revenue from fees brought about a change in the fee schedule.
5.
Overall, is funding sufficient to support all of the program needs?
If not, what are the problem areas?
- Yes C.
Laboratory Support (Category, II)
NRC Guidelines:
The RCP should have the laboratory support capability in-house, or readily available through established procedures, to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, etc., on a priority established by the RCP.
In addition, States regulating the disposal of low-level radioactive waste facilities in permanent disposal facilities should have access to laboratory support for radiological and non-radiological analyses associated with the licensing and regulation of low-level waste disposal, including soils testing, testing of environmental media, testing of engineering properties of waste packages and waste forms, and testing of other engineering materials used in the disposal of low-level radioactive waste.
Access to laboratory support should be available on an "as needed" basis for nonradiological analyses to confirm licensees' and
New Hampshire C applicants' programs and conditions for nonradiological testing should be prescribed in plans or procedures.
Questions:
1.
Describe changes in your laboratory support, such as new instruments, cutbacks, etc., in this period.
- We hired a lab scientist (radiochemist) for the rad material program.
Lab is being remodeled to contain a separate room as a radiochemistry wet lab.
2.
Have there been problems in obtaining timely and accurate lab results?
If yes, discuss the circumstances.
- No, the lab is part of the BRH.
D.
Administrative Procedures (Category II)
NRC Guidelines: The RCP should establish written internal procedures to assure that the staff performs its duties as required and to provide a high degree of uniformity and continuity in regulatory practices. These procedures should address internal processing of license applications, inspection policies, decommissioning and license termination, fee collection, contacts with communication media, conflict of interest policies-for.
employees, exchange of information and other functions required of the program. Administrative procedures are in addition to the technical procedures utilized in licensing, and inspection and enforcement.
Questions:
1.
Briefly list the changes, such as new procedures, updates, policy memoranda, etc., made in your written administrative procedures during the reporting period.
Include internal processing of license applications, 1
inspection policies, decommissioning and license termination, fee collection, contacts with media, conflict of interest policies for employees, and exchange of information procedures.
- A new task planning procedure was implemented to better
-i achieve the Bureau objectives.
Licensing review and incident document control procedures were written or revised Copies of the revised procedures have been assembled for review purposes.
E.
Manaaement (Category II)
NRC Guidelines:
Program management should receive periodic reports from the staff on the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions). RCP m
m
New Hampshire C-12 management should periodically assess workload trends, resources and changes in legislative and regulatory responsibilities to forecast needs for increased staff, equipment, services and fundings.
Program management should perform periodic reviews of selected license cases handled by each reviewer and document the results. Complex licenses (major manufacturers, low-level radioactive waste disposal facilities, large scope-Type A Broad, potential for significant releases to the environment) should receive second party review (supervisory, committee, consultant).
Supervisory review of inspections, reports and enforcement actions should also be performed.
For the implementation of very complex licensing actions, such as initial license review, license renewals and licensing actions associated with a low-level radioactive waste disposal facility, there should be an overall Project Manager responsible for the coordination and compilation of the diverse technical reviews necessary for the completion of the licensing action.
The Project Manager should have training or experience in one or more of the main disciplines related to the technical reviews which the Project Manager will be coordinating such as health physics, engineering, earth science or environmental science.
When regional offices or other government agencies are utilized, program management should conduct periodic audits of these offices.
Questions:
1.
How many management reviews of license cases were performed in this period?
- We are a small program and management (i.e., the RAM supervisor) reviews or gets involved with at least 80% of license cases, z.
Were all license reviewers included in the cases selected for management review? If not, explain.
- Yes 3.
What audits were made of regional and contract offices?
- N/A F.
Office Eouioment and Sucoort Services (Category II)
NRC Guidelines: The RCP should have adequate secretarial and clerical support. Automatic typing and Automatic Data Processing and retrieval capability should be available to larger (300-400 licenses) programs.
Similar services should be available to regional offices, if utilized.
States should have a document management system that is capable of organizing the volume and diversity of materials associated with licensing and inspection of
New Hampshire C-13 radioactive materials.
Professional staff should not be used for fee collection and other clerical duties.
Questions:
1.
Has the secretarial and clerical support been adequate during this period? If not, explain.
- Clerical support works for the Bureau Administrator and Bureau.
Clerical support appears to be adequate.
G.
Public Information (Category II)
NRC Guidelines:
Inspection and licensing files should be available to the public consistent with State administrative procedures.
It is desirable, however, that there be provisions for protecting from public disclosure proprietary information and information of a clearly personal nature. Opportunity for public hearings should be provided in accordance with UMTRCA and applicable State administrative procedure laws during the process of major licensing actions associated with UMTRCA and low-level radioactive waste in permanent disposal facilities.
Questions:
1.
Have changes occurred in the manner in which you handle public information?
- Not really. The edict is that all press inquiries go the DPHS press person. These can be delegated back.
Lots depends on who is in the Director's office as to how liberal the policy is.
IV.
PERSONNEL A.
Qualifications of Technical Staff (Category II)
NRC Guidelines:
Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences. Additional training and experience in radiation protection for senior personnel including the director of the radiation protection program should be commensurate with the type of licenses issued and inspected by the State.
For States regulating uranium mills and mill tailings, staff training and experience should also include hydrology, geology, and structural engineering.
(Additional guidance is provided in the Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement (46 FR 7540, 36969 and 48 FR 33376)).
For programs which regulate the disposal of low-level radioactive waste in permanent facilities, staff training and experience
- hould include civil or mechanical engineering, geology,
New Hampshire C-14 hydrology, and other earth science, and environmental science.
In both types of materials, staff training and experience guidelines hpply to available contractors and resources in State agencies other than the RCP.
Written job descriptions should be prepared so that professional qualifications needed to fill vacancies can be readily identified.
Questions:
1.
Please list all new professional personnel, indicating the degree they received, if applicable, and additional training and years of experience in health physics.
Summary of Training and Name Deareefs)
Experience in Health Physics Mario Iannaccone B.S.,
1979
- NH DPHS/BRH health major Biology physicist (0JT) since l
minor Chemistry 6/12/92 to present University of Lowell
- Licensing Procedures Course, NRC/ ASP, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, 6/13/94 - 6/17/94
- Industrial Radiography Course, Amersham /NRC-ASP, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, 6/6/94 - 6/10/94 l
- Applied Health Physics Course, ORISE, 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />, 2/1/93 - 2/22/93
- Radiological Emergency Response Operations Course, FEMA, 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, 9/29/92 -
10/10/92
- D.0.0. Portsmouth Naval Shipyard - Article 108/NAVSEA 389-288 "A" Qualified Radiological Control Monitor, 4 years l
1/88 -5/92 i
Deborah Russell B.A., 1985
- NH DPHS/BRH health l
major Microbiology physicist (0JT) since l
l minor Chemistry 8/21/92 to present j
l University of New l
Hampshire
- Licensing Procedures Course
}
NRC/ACP, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, 6/13/94
- 6/17/94 i
i b
l New Hampshire C-15
- Applied Health Physics Course, ORISE, 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />, 7/19/93 - 8/20/93
- Radiological Emergency Response Operations Course, FEMA, 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, 1/13/93 -
1/22/93 Kathleen McAllister B.S. 1977
- NH DPHS/BRH health major Biological physicist (0JT) since Sciences 1/22/93 to present minor Biochemistry University of New
- Industrial Radiography Hampshire Course, Amersham /NRC-ASP, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, 5/9/94 - 5/13/94 A.A.,
1975 major Liberal Arts
- Radiclogical Emergency Response Operations Course, FEMA, 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />, 5/1/94 -
5/8/94
- Applied Health Physics Course, ORISE, 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />, 2/6/94 - 3/11/94
- Management & Disposal of Radioactive Waste Course, Harvard School of Public Health, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br />, 7/6/92 -
7/10/92
- H.P. Technologist, LLRW Management, New England Medical Center, Boston 7/92 - 1/93
- Article 108/NAVSEA 389-0288 "A" Qualification Portsmouth Naval Shipyard, 2248 hours0.026 days <br />0.624 hours <br />0.00372 weeks <br />8.55364e-4 months <br />, 7/89 - 12/91 Twila Kenna B.A.
- NH DPHS/BRH radiochemist major Zoology (0JT) 4/1/94 to present University of New Hampshire
- Biological research and experimentation involving M.S., Anial Science radionuclides; RAI uses University of New Harvard University, 3/82 -
Hampshire 8/87-Ph.D., Dairy Science
- Laboratory use of Virginia Polytechnic radionuclides, Virginia
~
New Hampshire C-16 Institute and State Polytechnic Institute and University State University, 9/78 - 12/81 B.
Staffina level (Category II) 4 NRC Guidelines:
Professional staffing level should be approximately 1-1.5 person-year per 100 licenses in effect. RCP must not have less than two professionals available with training and experience to operate RCP in a way which provides continuous coverage and continuity.
The two professionals available to operate the RCP should not be supervisory or management personnel.
For States regulating uranium mills and mill tailings current indications are that 2-2.75 professional person-years' of effort, including consultants, are needed to process a new mill license (including in situ mills) or major renewal to meet requirements of Uranium Mill Tailings Radiation Control Act of 1978.
States which regulate the disposal of low-level radioactive waste in permanent disposal facilities should allow a baseline RCP staff effort of 3-4 professional technical person-years (in addition to the two professionals for the basic RCP indicated in the first bullet of this indicator). However, in some cases, the level of site activity may be such that a lower level is adequate, particularly if contractor support is on call.
In any event, staff resources should be adequate to conduct inspections on a.
routine basis during operations of the LLW facility, including inspection of incoming shipments and licensee site activities and to respond to emergencies associated with the site. During periods of peak activity additional staff or specialty consultants should be available on a timely basis.
Questions:
1.
Complete a table listing the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual.
Include the name, position, and fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills.
If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program.
If consultants were used to carry out the program's RAM responsibilities,-
include their efforts. The table heading should be:
j NAME POSITION AREA 0F EFFORT FTE%
There are four health physicists I's who divide their time equally between the X-Ray and RAM Sections.
Each devotes 0.35 FTEs to the RAM Section. The Section Supervisor l
applies 0.9 FTEs to RAM Section (Note:
NH FTE is 1800 l
hours).
l l
1 New Hampshire C-17 2.
Is the staffing level adequate to meet normal and special needs and backup?
If not, explain.
- Yes - once trained 3.
Do you currently have vacancies? If so, when do you expect to. fill them?
- Yes - 1 Princ: pal Planner position in the Emergency Response Section - Hope to fill in August or September of this year.
C.
Staff Supervision (Category II)
NRC Guidelines: Supervisory personnel should be adequate to provide guidance and review the work of senior and junior personnel.
Senior personnel should review applications and i
inspect licenses independently, monitor work of junior personnel, and participate in the establishment of policy. Junior personnel should be initially limited to reviewing license applications and inspecting small programs under close supervision.
Questions:
1.
Identify your senior personnel assigned to monitor the work of junior personnel.
- See Appendix B (organizational charts)
D.
Trainina (Category II)
NRC Guidelines:
Senior personnel should have attended NRC core i
courses in licensing orientation, inspection procedures, medical practices and industrial radiography practices.
The RCP should have a program to utilize specific short courses and workshops to maintain appropriate level of staff technical competence in areas of changing technology. The RCP staff should be afforded opportunities for training that is consistent with the needs of the program.
Questions:
1.
Prepare a table listing all of the training courses, workshops, seminars, symposia, etc. that your materials personnel have attended since the last review.
The table heading should be:
Student Course Soonsor Dates I
1 5
Mario Iannaccone Troxler Trng Crse Troxler 7/17/92 (8 hrs.)
Computer Trng Dataease 8/18/92 - 8/21/92 (8 hrs.)
ASA 8/31/92 (3 hrs.)
DOS HDM Shell 9/03/92 (3 hrs.)
4 e-,..
New Hampshire C-18 Ali Bureau Meeting 9/16/92 (2 hrs.)
VT Yankee ER0 Trng 9/23/92 (8 hrs.)
Seabrook Statn ER0 Supv Trng 10/14/92 (6 hrs.)
Special Topics Wrkshp review 10/15/92 (4 hrs.)
NE Rad Health NERHC 11/03/92 -
Comm Mtg 11/06/92 X-ray TECH 11/20/92 SS of EOF Ex 11/23/92 (7 hrs.)
All Bureau Mtg 01/21/93 (2 hrs.)
VY Ingestion Pathway 01/27/93 (4 hrs.)
NEXT 93 Trng 03/17/93 -
03/18/93 (16 hrs.)
All Bureau Mtg 04/08/93 Hospital Inspection Trng 08/18/93 (8 hrs.)
08/24/93 (8 hrs.)
All Bureau Mtg 12/01/93 SS PT20 12/02/93 (2 hrs.)
SS Comp Trng METPK 12/21/93 (4 hrs.)
NH Personnel Trng 01/26/94 (8 hrs.)
NEXT 94 02/22/94 -
02/24/94 (16 hrs.)
New Data base Trng 03/15/94 (2 hrs.)
Annual Meeting NECHPS 05/05/94 (8 hrs.)
Licensing Course NRC 06/13/94 -
06/17/94 Equiv New Pt 20 Trng 06/27/94 06/30/94 Part 20 Workshop DPHS/BRH 07/25/94 Deborah Russell Medical Uses NRC 08/15/94 -
08/19/94 Inspection NRC 08/08/94 -
Procedures 08/12/94 Part 20 Workshop DPHS/8RH 07/25/94 Part 20 Training DPHS/BRH 06/27/94 and 06/30/94 Licensing Course NRC 06/13/94 -
06/17/94 Annual Meeting NECHPS 05/05/94 Glenbrook Tech-Glenbrook 04/93 nologies Lixiscope Trng Annual Meeting NERHC 11/02/93 -
11/05/93 Ingestion Pathway 01/27/93 Exposure Health Physics &
ORISE Summer 94 Radiation Protection RER0 FEMA 01/12/93.-
01/23/93 Annual Meeting NERHC 11/03/92 -
11/06/92
. = -
5 4
New Hampshire C-19 Kathleen Industrial NRC 05/94 McAllister Radiography.
RER0 FEMA 05/94 4
Health Physics &
ORISE Winter 94 Radiation Protection Troxler Training Troxler 07/93 for Moisture Density Gauges Glenbrook Tech-Glenbrook 04/93 nologies Lixiscope Trng J. Christopher NH BRH Part 20 NH BRH 07/25/94 Pirie Training for Licensees &
Registrants NH BRH in-house NH BRH 06/30/94 and Part 20 Training 06/27/94 SDMP Workshop NRC 06/01/94 QM Rule Workshop NRC 04/20/94 RAM Transportation NRC 09/27/93 -
10/01/93 Gauge Operators Troxler 07/20/93 Trng Course Rad Protection NRC 12/07/92 -
Engineering 12/11/92 Course Industrial NRC 04/06/92 -
Radiography 04/10/92 2.
If any of your materials staff currently need NRC training,-
please identify the employees and the courses needed.
i Mario Iannacce.. # P spection Procedures Course, NRC Medical Us: Course, 4RC RAM Transportation Course, NRC Well 4
Logging :.ourse NRC Aaiiation Protection Engineering Course.
Deborth fou ull: rtr industrial Radiography Course, NRC RAM Trane..mriatio:1 Co;rse, NRC Well logging Course, NRC Radiat;c., r tection Engineering Course.
Kathleen McAllister: NRC Materials Licensing Course, NRC j
Inspecting Procedures Course, NRC Medical Uses Course, NRC RAM Transportation Course, NRC Well logging Course, NRC Radiation Protection Engineering Course.
Twila Kenna:
5-week Applied Health Physics Course j
J. Christopher Pirie: NRC Well Logging Course
New Hampshire C-20 E.
Staff Continuity (Category II)
NRC Guidelines: Staff turnover should be minimized by combinations of opportunities for training, promotions, and competitive salaries.
Salary levels should be adequate to recruit and retain persons of appropriate professional qualifications.
Salaries should be comparable to similar employment in the gergraphical area. The RCP organization structure should i,c ;uch that staff turnover is minimized and program continuity maintained through opportunities for promotion.
Promotion opportunities should exist from junior level to senior level or supervisory positions. There also should be opportunity for periodic salary increases compatible with experience and responsibility.
Questions:
1.
List the RCP salary schedule as follows:
Position Title Annual Salary Ranae Administrator, Radiological Health Bureau 36,231-43,193 Health Physicist II, RAM Supervisor 31,726-37,849 Health Physicist I 29,094-34,437 Lab Scientist III (radiochemist) 24,648-29,094 2.
Identify the technical staff wha lef t the Agreement program during this period and, if possible, give the reasons for the turnovers.
- Donald Halle - HPII Supervisor, Radiation Machine Section, retired 4/1/92.
- Wayne Johnston - HPI, became HPII to replace Don as Section Supervisor on 10/9/92.
- Charles Putnam - Principal Planner - Emergency Response, retired 4/30/94.
V.
LICENSING A.
Technical Ouality of Licensina Actions (Category I)
NRC Guidelines: The RCP should assure that essential elements of applications have been submitted to the agency, and which meet current regulatory guidance for describing the isotopes and quantities to be used, qualifications of persons who will use material, facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions.
Additionally, in States which regulate the disposal of low-level radioactive waste in permanent disposal facilities, the RCP should assure that essential elements of waste disposal applications meet State licensing requirements for waste product and volume,
9
-New Hampshire C-21 qualifications of personnel, facilities and equipment, operating and emergency procedures, financial qualifications and assurances, closure and decommissioning procedures and institutional arrangements in a manner sufficient to establish a basis for licensing action.
Licensing activities should be adequately documented including safety evaluation reports, product certifications or similar documentation of the license review and approval process.
Prelicensing visits should be made for complex and major licensing actions.
Licenses should be. clear, complete, and accurate as to. isotopes, forms, quantities, authorized uses, and permissive or restrictive conditions.
The RCP should have procedures for reviewing licenses prior to renewal to assure that supporting information in the file reflects the current scope of the licensed program.
Questions:
1.
Please list the State's major licensees by name, license number and type.
Include:
o Broad Licenses o
LLW Disposal o
LLW Brokers (All Types) o Manufacturers and Distributors o
Uranium Hills o
Irradiators (Other than Self-Contained) o Nuclear Pharmacies o
Other Licenses With a Potential Significance for Environmental-Impact The table heading should be:
Licensee Name License Number License Tvoe Dartmouth College 276R Broad A Dartmouth College 382R Irradiator >10,000 Ci University of NH 190R Broad A 2.
Identify any major, unusual, or complex licenses issued, renewed or terminated in this period.
2 Nuclear Pharmacy applications reviewed (still pending final approval).
1 Research Irradiator (>10,000 Ci), license issued
)
I small, self-contained, self-shielded irradiator, license amendment issued l
1 sealed source distributor, license issued 3.
Please list all licensees requiring contingency plans using l
the NRC criteria from 10 CFR Parts 30, 40 and 70.
New Hampshire C-22
- None 4.
Discuss any variances in your licensing policies or procedures or exemptions from the regulations granted during the period.
- None 8.
Adeouacy of Product Evaluations (Category I)
NRC Guidelines: RCP evaluations of manufacturer's or distributor's data on sealed sources and devices outlined in NRC, State, or appropriate ANSI Guides, should be sufficient to assure integrity and safety for users. The RCP should review manufacturer's information on labels and brochures relating to radiation health and safety, assay, and calibration procedures for adequacy. Approval documents for sealed source or device designs should be clear, complete and accurate as to isotcpes, forms, quantities, uses, drawing identifications, and permissive or restrictive conditions.
Approval documents for radioactive waste packages, solidification and stabilization media, or other vendor products used to treat radioactive waste for disposal should be complete and accurate as to the use, capabilities, limitations, and site specific restrictions associated with each product.
Questions:
1.
Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the reporting period.
The table heading should be:
J SS&D Manufacturer, Type of Indicate Indicate if Registry Distributor or Device if Agreement Number Custom User or Source NARM Material NH-0702-S-101-S CIS-US, Inc.
Flood Source X
for medical uses 2.
List the applications for SS&D registrations for which registry documents have not yet been issued.
- None l
C.
Licensina Procedures (Category II)
NRC Guidelines: The RCP should have internal licensing guides, checklists, and policy memoranda consistent with current NRC practice.
j In States which regulate the disposal of low-level radioactive waste in permanent disposal facilities, the RCP should have l
New Hampshire C i-program specific licensing guides, plans and procedures for license review'and policy memoranda which relate to specific aspects of waste disposal.
The program should include the preparation of safety evaluation reports, product certifications, or similar documentation of license review and approval process.
License applicants (including applicants for renewals) should be furnished copies of applicable guides and regulatory positions.
The present compliance status of licensees should be considered in licensing actions.
Under the NRC Exchange-of-Information program, evaluation sheets, service licenses, and licenses authorizing distribution to general licensees and persons exempt from licensing should be submitted to NRC on a timely basis.
Standard license conditions comparable with current NRC standard license conditions should be used to expedite and provide uniformity in the licensing process.
Files should be maintained in an orderly fashion to allow fast, accurate retrieval of information and documentation of discussions and visits.
Questions:
1.
What changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
New forms or checklists developed during the review period include license application review form, supervisory review form, pre-licensing inspection form,and physician-user application checklist were developed.
The following new regulatory guides were furnished to State licensees:
a.
" Guide for the Preparation of License Applications for Laboratory and Industrial Use of Small Quantities of Radioactive Material" b.
" Guide of the Preparation of License Applications for Nuclear Pharmacy Operations" c.
" Guide for Change in Name or Ownership of Radioactive Material License" d.
" Guide for Application for Mobile Nuclear Medicine Service" e.
" Guide for the Preparation of License Applications for Leak Testing" f.
" Guide for the Preparation of License Applications for the Use of Bone Mineral Analyzers"
New Hampshire C-24 g.
" Guide for Requests for Use of Radioactive Materials Compactor" VI.
COMPLIANCE A.
Status of Insoection Praqrs (Category I)
NRC Guidelines:
The State RCP should maintain an inspection program adequate to assess licensee compliance with State regulations and license conditions.
The inspection program in all States should provide for the inspection of licensee's waste generation activities under the State's jurisdiction.
In States which regulate the disposal of low-level radioactive waste in permanent disposal facilities, the RCP should include provisions for pre--operational, operational, and post-operational facility inspections. The inspecticns should cover all program elements which are relevant at the time of the inspection and be performed independently of any resident inspector program.
In addition, inspections should be conducted on a routine basis during the operation of the LLW facility, including inspection of incoming shipments and licensee site activities.
The RCP should maintain statistics which are adequate to permit Program Management to assess the status of the inspection program on a periodic basis.
Information showing the number of inspections conducted, the number overdue, the length of time overdue and the priority categories should be readily available.
There should be at least semiannual inspection planning for the number of inspections to be performed, assignments to senior versus junior staff, assignments to regions, identification of special needs and periodic status reports.
When backlogs occur the program should develop and implement a plan to reduce the backl og.
The plan should identify priorities for inspections and establish target dates and milestones for assessing progress Questions:
1.
Prepare a table identifying the Priority 1, 2, and 3 licenses with inspections that are overdue by more than 50%
of their scheduled frequency.
Include the licensee name, inspection priority, the due date, and the number of months the inspection is overdue. The list should include initial inspections that are overdue.
The table heading should be:
Insp. Freq.
Licensee Name (Years)
Due Date Months 0/D Dartmouth College
.l
- 08/01/93 12
- Note: Academic broad license; would fall under NRC
4 New Hampshire C-25' Priority 2, with due date 08/01/94.
2.
Describe your action plan for completing your overdue
' inspections.
If there is a backlog of (1) inspections with an inspection frequency of 3 years or less that are overdue by more than 50%
of their scheduled frequency, or (2) inspections with lower inspection frequencies that are overdue by more than 100% of their scheduled frequency, please include with the questionnaire a written-action plan for eliminating the backlog.
4 The written action plan should contain inspection priorities, numerical and time frame goals for reducing the backlog, provide a method to measure the program's progress, and provide for management review of the program's success 4
in meeting the goals.
- The Dartmouth College inspection is scheduled to be conducted on September 8 and 9, 1994.
The inspection team-will consist of 2 Health Physicists and a radiochemist.
A review of the inspection schedule for the next four months-indicates a need for emphasis on higher priority inspections.
Also, several of the lower priority inspections can be accomplished within a short amount of time.
Progress will be tracked very carefully.
3.
How many on-site close-out inspections prior to license termination were made during the reporting period?
- 14 4.
How many on-site close-out inspections are pending at this time?
- None i
5.
How many reciprocity notices were received in the reporting l
period?
l
- 250, including gauges i
6.
How many reciprocity inspections were conducted?
- 10 i
i 1
.)
t
N2w Hampshire C-26 7.
Other than reciprocity licensees, how many field inspections of radiographers were performed?
-0 Practically impossible, considering that the only one radiographer authorized for field activities, works rarely in New Hampshire; most field work in Massachusetts 8.
What percentage is this of your total number of radiographer licensees?
s
- 0%
B.
Inspection Frecuency (Category I)
NRC Guidelines: The RCP should establish an inspection priority system. The specific frequency of inspections should be based upon the potential hazards of licensed operations, e.g., major processors, broad licensees, and industrial radiographers should be inspected approximately annually -- smaller or less hazardous operations may be inspected less frequently.
The minimum inspection frequency including for initial inspections should be no less than the NRC system.
Questions:
1.
Identify individual licensees or groups of licensees the State is inspecting more frequently than called for in the State's inspection priority system and discuss the reason-for the change.
- A few licensees have been logged into the database as needing follow-up inspections, based on findings of L
previous inspections.
C.
Insoector's Performance and Capability (Category I)
NRC Guidelines:
Inspectors should be competent to evaluate health-and safety problems and to determine compliance with State regulations.
Inspectors must demonstrate to supervision an understanding of regulations, inspection guides, and policies prior to independently conducting inspections.
For the inspection of complex licensed activities such as permanent low-level i
radioactive waste disposal facilities, a multidisciplinary team approach is desirable to assure a complete compliance assessment.
The compliance supervisor (may be RCP manager) should conduct annual field evaluations of each inspector to assess performance and assure application of appropriate and consistent policies and guides.
Questions:
1.
Prepare a table showing the number and types of supervisory accompaniments made during the reporting period. Include:
o
--+
1
(
New Hampshire C-27 i
Suoervisor Inspector License Tvoe Date Dennis O'Dowd D. Russell Gauge 3/23/93 Dennis O'Dowd K. McAllister R&D 5/14/93 Dennis O'Dowd M. Iannaccone Gauge 7/10/93 j
Dennis O'Dowd M. Iannaccone Medical 5/24/94 Dennis O'Dowd D. Russell Medical 6/09/94 i
Dennis O'Dowd J. C. Pirie Medical 6/15/94 l
Note:
K. McAllister is scheduled to be accompanied on an upcoming inspection. Other supervisory accompaniments were made during new inspector's initial training period.
2.
Were all inspectors accompanied at least annually by the compliance supervisor during the reporting period? If not, explain.
- Yes l
D.
Resoonses to Incidents and Alleaed Incidents (Category I)
NRC Guidelines:
Inquiries should be promptly made to evaluate the need for on-site investigations. On-site investigations should be l
promptly made of incidents requiring reporting to the Agency in l
less than 30 days (10 CFR 20.403 types).
For those incidents not requiring reporting to the Agency in less than 30 days, investigations should be made during the next scheduled inspection.
On-site investigations should be promptly made of non-reportable incidents which may be of significant public interest and concern, e.g. transportation accidents.
Investigations should include in-depth reviews of circumstances and should be completed on a high priority basis. When appropriate, investigations should include reenactments and time-study measurements (normally within a few days).
Investigation (or inspection) results should be documented and enforcement action taken when appropriate.
State licensees and the NRC should be notified of pertinent information about any incident which could be relevant to other licensed operations (e.g., equipment failure, improper operating procedures). Information on incidents involving failure of equipment should be provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency. The RCP should have access to medical consultants when needed to diagnose or treat radiation injuries. The RCP should use other technical consultants for special problems when needed.
Questions:
i
New Hampshire C-28 1.
Identify any incidents that required NRC notification, either by telephore or by written report.
- 2 nuclear density gauge incidents 2.
Identify any incidents that required Abnormal Occurrence Reports.
- None 3.
Identify any incidents that involved equipment or source failure or deficient operating procedures issued by the manufacturer.
Discuss Were the NRC and other State licensees who might be affected notified?
Was the information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency?
Please provide details for each case.
- None identified.
4.
If the RCP utilized medical or technical consultants for an emergency during the reporting period, please describe the circumstances for each case.
- No 5.
In the reporting period, were there any cases involving possible criminal wrongdoing that were looked into or are presently undergoing review?
If so, please describe the circumstances for each case.
- No E.
Enforcement Procedures (Category I)
NRC Guidelines:
Enforcement Procedures should be sufficient to provide a substantial deterrent to licensee noncompliance with regulatory requirements.
Provisions for the levying of monetary penalties are recommended.
Enforcement letters should be issued within 30 days following inspections and should employ appropriate regulatory language clearly specifying all items of noncompliance and health and safety matters identified during the inspection and referencing the appropriate regulation or license condition being violated.
Enforcement letters should specify the time period for the licensee to respond indicating corrective actions and actions taken to prevent recurrence (normally 20-30 days). The inspector and compliance supervisor should review licensee responses.
New Hampshire C-29 Licensee responses to enforcement letters should be promptly acknowledged as to adequacy and resolution of previously
~ 1 unresolved items. Written procedures should exist for handling escalated enforcement cases of varying degrees.
Impounding of material should be in accordance with State administrative procedures.
Opportunity for hearings should be provided to assure impartial administration of the radiation control program.
Questions:
1.
If during the reporting period the State issued orders, applied civil penalties, sought criminal penalties, impounded sources, or held formal enforcement hearings, identify these cases and give a brief summary of the circumstances and results for each case.
ORDERS ISSVED Lic. No. 319R; Electropac; Lixiscope; Order to Show Cause (why license should not be revoked); history of non-compliance and inability to correct and present violations; resulted in voluntary termination.
Unlicensed; Continental Paving; Cease and Desist Order; Possession of RAM without a license; transferred gauge to manufacturer; initially sought license, but subsequently withdrew application.
GEI Consultants; portable gauge; Cease and Desist Order; possession of RAM without a license; transferred to another specific licensee.
Eventually obtained licensure.
License No. 296R; Atlantic Testing Laboratories; license suspension; based on several significant violations and careless disregard for regulatory requirements; (portable L
gauges); license still suspended Lic No. 339R; Hixlee Environmental; microcurie Ra-226 source; order requesting information INFORMAL ENFORCEMENT CONFERENCES Lic. No. 319R, Electropac; see above Continental Paving; see above GEI Consultants; see above Lic. No. 367R; Granite State Environmental; X-Ray Fluorescence Analyzer; significant violations
't Lic. No. 353R; Heynen-Teale Engineers, Inc.; violations which resulted in crushed portable gauge t
New Hampshire C-30 Lic. No. 279R; Resource Analysts, Inc.; Carbon 14 uses; failure to properly decontaminate / decommission facilities Lic. No. 257R; Valley Regional Hospital; medical diagnostic uses; significant violations Lic. No 336 R; Thomas Murphy; bone analyzer; history of non-compliance 2.
Discuss changes made in the enforcement procedures during the reporting period.
More frequent use of informal conferences; these appear to be quite effective in producing desired effect (i.e.,
improved compliance by licensee).
F.
Inspection Procedures (Category II)
NRC Guidelines:
Inspection guides, consistent with current NRC guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in tile inspection of licensed programs.
NRC Guides may be used if properly supplemented by policy memoranda, agency interpretations, etc. Written inspection policies should be issued to establish a policy for conducting unannounced inspections, obtaining corrective action, following up and closing out previous violations, interviewing workers and observing operations, assuring exit interviews with management, and issuing appropriate notification of violations of health and safety problems.
Procedures should be established for maintaining licensees compliance histories. Oral briefing of supervision or the senior inspector should be performed upon return from nonroutine inspections.
For States with separate licensing and inspection staffs, procedures should be established for feedback of information to license reviewers.
Questions:
1.
What changes were made to your written inspection procedures during the reporting period?
The inspection procedures were updated and expanded.
A complete package of inspection procedures and forms has been prepared for the review team.
G.
Inspection Reports (Category II)
NRC Guidelines:
Findings of inspections should be documented in a report describing the scope of inspections, substantiating all i
items of noncompliance and health and safety matters, describing the scope of licensees' programs, and indicating the substance of discussions with licensee management and licensee's response.
Reports should uniformly and adequately document the results of inspections and identify areas of the licensee's program which
New Hampshire C-31 should receive special attention at the next inspection.
Reports should show the status of previous noncompliance and the independent physical measurements made by the inspector.
Questions:
1.
What changes were made in the formats of your reports or inspection forms during this period?
No significant changes; a couple of new forms.
H.
Confirmatory Measurements (Category II)
NRC Guidelines:
Confirmatory measurements should be sufficient in number and type to ensure the licensee's control of materials and to validate the licensees measurements.
In States which regulate the disposal of low-level radioactive waste in permanent disposal facilities, access to testing should be available on an "as needed" basis for confirming licensees' and applicants' programs for measurements related to nonradiological aspects of facility operations such as soils and materials testing and environmental sampling and analysis to demonstrate compliance with 10 CFR Part 61 or compatible Agreement State regulations and ensure facility performance.
Conditions for nonradiological testing should be prescribed in plans or procedures.
RCP instrumentation should include the following types:
GM Survey Meter:
0-50 mr/hr Ion Chamber Survey Meter:
up to several R/hr Neutron Survey Meter:
Fast & Thermal Alpha Survey Meter: 0-100,000 c/m Air Samplers: Hi and Low Volume Lab Counters: Detect 0.001 pc/ wipe Velometers Smoke Tubes Lapel Air Samplers Instrument calibration services or facilities should be readily available and appropriate for instrumentation used.
Licensee equipment and facilities should not be used unless under a service contract.
Exceptions for other State Agencies, e.g., a State University, may be made. Agency instruments should be calibrated at intervals not greater than that required to licensees being inspected.
(Note: Addition types of instrumentation that are highly desirable are thin window plastic or Nal detectors for low energy gammas and
" micro-R" meters with audio signal for searching for lost gamma emitter sources.)
Questions:
New Hampshire C-32 1.
Describe any changes in your instrumentation or methods of calibration in this reporting period.
With Twila Kenna in radiochemistry working for RAM section, a fully implemented calibration program is in effect.
Specifically, instruments are routinely sent to South Carolina's calibration laboratory (a CRCPD accredited calibration facility) or the specifically-licensed instrument manufacturers's facility.
During recent deliberations by the staff in planning for next year's equipment purchases, a high-volume air sampling system and a velometer were added to our needs list.
l I
4
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J New Hampshire C-33 PART II PROGRAM STATISTICS as of 8/15/94 1.
How many specific licenses are currently in effect?
- 99 2.
How many technical FTE's (not including administrativa, clerical or i
unfilled vacancies) are currently assigned to the:
1 Radioactive materials program?
~.35 FTE/HPI X 4
= 1.4
.9 FTE/HHPII X 1
_22 2.3 Low-Level waste program?
Uranium mills program?
3.
Compute the professional / technical person-year effort of person-years per 100 licenses (excluding management above the direct RAM supervisor, vacancies and personnel assigned to mills and burial site licenses).
Count only time dedicated to radioactive materials.
2.3 x100 =2. 3 FTE/100SL's gg 4
During the review period:
Note:
In addition to items below, 15 applications were denied; 23 applications were withdrawn a.
How many new licenses were issued?
- 14 b.
How many licenses were terminated?
- 24 c.
How many licenses were renewed?
32 full renewals
- 209 simple renewals, annually form and fee only d.
How many amendments were issued?
- 142
-C-34 e.
How many SS&D evaluations were completed?
s
~
- 1 (NARM source) f.
How many prelicensing visits were made?
-4 g.
How many new licenses (or major amendments) were hand delivered to the licensee?
-3 h.
How many reports of materials incidents or allegations were received?
- 12 1.
How many on-site incident investigations were conducted?
-9 J.
How many misadministrations were reported?
- 4 all diagnostic k.
How many civil penalties were imposed?
-0 1.
How many orders were issued?
I
- Ref. VI, E.1 above 5.
Please complete the following table using the license categories as j
shown, and including the total number of specific licenses in each category, the priority or inspection frequency, the number of inspections made during the review period, and the number of overdue 4
inspections in each category.
(In Priorities 1-3, include those overdue j
by more than 50% of their scheduled inspection frequency; in lower priorities,-include those overdue by more than 100% of their scheduled frequency.)
- See next page.
F k
I
-.J
New Hampshire C-35 Insp.
No.
No.
No. of Freq.
Insps.
Overdue-license Cateaory Licenses
-(vears)
Made Insos.
Broad A Academic 2
1 l#
Industrial Radiography 2
1 Irradiator > 10,000 Ci-1 1
2 1
Teletherapy Medical, other than teletherapy 22 2
21 Distribution only 2
2 2
R&D 1
2 l
Source Material-(Th-242) 1 2
1 Fluo?escence X-Ray Analyzer 16 4
8-Lixiscope 1
4 1
Gas Chromatograph 6
4 4
Portable Gauge 12 4
7 Fixed Gauge 7
4 3
In vitro use of RAM 5
4 3
Service, Testing, Calibration 7
4 4
Other Sources (betascope) 1 4
1 Source Material 4
4 3
Other 7
5 TOTALS 99 l
)
Information not available.
Data taken from "last inspection" computer listing.
Priority I licenses were inspected more than once in reporting d
period.
Academic broad license would fall under NRC Priority 2, with due date 08/01/94.
9 Information not available.. Data taken from computer listing do not reflect total inspections if more than one inspection was conducted for any one licensee.
t k
1 6
ey.-
y
APPENDIX D REVIEW 0F LICENSING FILES o
5 File No. 1 Licensee:
Medarex, Inc.
Address:
West Lebanaa. NH
. License No.
350R License Type:
R&D Licensing Action: Termination Action Date: _
10/7/93 Comment:
Good close-out inspection form File No. 2 Licensee:
Verax Corporation Address:
Lebanon, NH License No.
348R License Type:
R&D Licensing Action: Termination Action Date:
1/25/94 Comment:
None File No. 3 Licensee:
OSRAM Slyvania, Inc Address:
Manchester, NH License No.
388R License Type:
R&D Licensing Action: New Action Date:
2/23/94 Comment:
None File No. 4 Licensee:
Simplex Technologies, Inc.
Address:
Portsmouth, NH License No.
143R License' Type:
Fixed gauges Licensing Action: Renewal in entirety Comment:
Cannot use post office box as address in item 2 File No. 5 Licensee:
Trustees of Dartmouth College Address:
Hanover, NH License No.
382R License Type:
Large, self-contained irradiator Licensing Action: Complex amendment Action Date:
7/21/94 Comment:
Wrong date listed for one tie-down document i
New Hampshire D-2 File No. 6 Licensee:
Sanborn, Head and Associates, Inc.
Address:
Concord, NH License No.
390R License Type:
Portable gauge Licensing Action: New Action Date:
6/2/94 Comments:
a)
Conducted pre-licensing inspection b)
Personally delivered license c)
Good work File No. 7 Licensee:
Lockheed Sanders, Inc.
Address:
Nashua, NH License No.
175R License Type:
Portable analytic gauge Licensing Action: Renewal in entirety Action Date:
4/4/94 Comment:
None File No. 8 Licensee:
Ingvor Larson Address:
Pelham, NH License No.
341R License Type:
Service - gauges Licensing Action: Renewal in entirety Action Date:
3/9/93 Comment:
None l
i d
APPENDIX E REVIEW OF INSPECTION FILES File No. 1 Licensee:
Mary Hitchcock Memorial Hospital City, State:
Lebanon, NH License Number:
181R Inspection Priority:
1 Lead Inspector:
J. C. Pirie Type of Inspection:
Routine Inspection Date:
6/23/93 Issuance Date:
8/23/93 Program Code / Type:
F - Teletherapy Comments:
a)
No documentation of 6/92 inspection on file.
b)
Took 2 months to get NOV out to the licensee.
c)
Generally, good documentation.
d)
Took a month and a half to get the licensee's NOV response to the reviewer.
e)
Supervisor signed off on field notes about a week after NOV was issued.
Inspector says that the supervisor must have been out of the office when the NOV was issued.
f)
No information on the instrumentation used by the inspector.
Extensive documentation of radiation levels and areas surveyed.
File No. 2 Licensee:
Venegas Industrial Testing Laboratories, Inc.
City, State:
Nashua, NH License Number:
217R Inspection Priority:
1 Lead Inspector:
J. C. Pirie Type of Inspection:
Follow-up Inspection Date:
6/29/93 Issuance Date:
7/1/93 Program Code / Type:
B(1) - Industrial Radiography - Temporary Job Sites Comments:
a)
Documented very well.
b)
Licensee's 7/11/94 license renewal authorizes RTS Model 702 sources. NRC's order of 5/20/93 prohibited use of these sources with serial numbers less than 1867. The annual license renewal should have qualified the authorization for the sources.
The section supervisor explained this was an oversight and that the licensee has disposed of this source. The section supervisor was asked to follow up on this issue.
c)
Survey instrument was calibrated within the past 3 months.
d)
Instrument information provided.
New Hampshire E-2 File No. 3 Licensee:
Radiation Safety and Control Services, Inc.
City, State:
Stratham, NH License Number:
381R Inspection Priority:
3 Lead Inspector:
M. Iannaccone Type of Inspection:
Initial Inspection Date:
8/31/93 Issuance Date:
Not yet issued Program Code / Type:
I - Calibration of Instruments Comments:
a)
Results of the 8/31/93 inspection have not yet been sent to the licensee.
Supervisor agrees to follow-up promptly.
b)
Field notes not yet signed off as being reviewed; however, mark-up of draft letter to licensee shows that supervisor has been involved on this issue.
c)
In general, poor documentation.
Field notes appear to be used only as a checklist.
d)
No inforration on survey instrument used by the inspector.
File No. 4 Licensee:
Catholic Medical Center City, State:
Manchester, NH License Number:
109R Inspection Priority:
2 Lead Inspector:
M. Iannaccone/K. McAllister Type of Inspection:
Routine Inspection Date:
3/23/94 Issuance Date:
4/11/94 Program Code / Type:
F - Diagnostic / Limited Therapy Comments:
a)
Acknowledgement letter not yet sent for licensee's 6/2/94 response.
b)
No indication that a note to licensing on item 3.a. was followed-up.
During discussion with IMPEP reviewer, supervisor wrote a note to license reviewer and put the note in the file.
c)
No numerical results provided on independent measurements.
d)
No section on the field notes form for postings, ALARA, leak tests.
e)
Good that operations were obsarved, and that these observations were documented by the inspectors.
f)
Great follow-up on licensee's response.
g)
No serial number or calibration date on inspectors' instrumentation.
Report does identify model,
_ = ~
New Hampshire E-3 File No. 5 Licensee:
Frank Whitcomb Construction Corp.
City, State:
Walpole, NH License Number:
274R Inspection Priority:
3 Lead Inspector:
K. McAllister Type of Inspection:
Special/ Routine Inspection Date:
5/24/93 Issuance Date:
6/24/93 Program Code / Type:
D(2) - Portable Gauges Comments:
a)
Good documentation of_ telephone calls with an unknown caller and with the licensees involved.
b)
Narrative report leaves many areas unaddressed.
Cannot tell from the narrative'whether the routine inspection was conducted in sufficient depth and scope.
BRH believes this approach was sufficient.
c)
Good follow-up on amendment request to change Radiation Safety Officer.
d)
Excellent letter to licensee.
It clearly states that BRH considered an order, but would not issue one at this time due to the licensee's performance and commitments. However repeat violations are unacceptable, e)
Report shows instament type and radiation levels. No serial number or calibration date provided.
File No. 6 Licensee:
Head and Neck Specialty Group of New Hampshire City, State:
Somersworth, NH License Number:
293R Inspection Priority:
3 Lead Inspector:
K. McAllister Type of Inspection:
Routine Inspection Date:
5/5/93 Issuance Date:
6/2/93 Program Code / Type:
F(2) - In Vitro Use of Radioactive Material Comments:
i a)
Exit meeting held with the laboratory supervisor,_instead of the physician.
If possible, should have been held with the physician.
b)
Enforcement letter sent on 6/2/93.
Licensee did not reply at that time.
Follow-up letter asking for a reply was sent on 5/16/94.
Inspector says that a reply was received on 6/6/94.
Long delay in-receiving reply.
c)
Training not covered on field note form.
This subject should be added to the form.
d)
Great idea about the licensee using a spill tray to mitigate consequences of leaking bottles.
i:
New Hampshire E-4 File No. 7 Licensee:
Littleton Hospital
' City, State:
Littleton, NH License Number:
263R 4
^
Inspection Priority:
2 Lead Inspector:
D. Russell /K. McAllister Type of Inspection:
Routine Inspection Date:
4/4/94 Issuance Date:
7/14/94 Program Code / Type:
F - Diagnostic Only 3
Comments:
a)
Took 3 months to issue results to licensee, b)
Good to address physician's exposure with respect to ALARA.
c)
Violation A does not have any supporting documentation in the field. notes -- does not appear to be mentioned.
d)
Violation B is also not supported in the field notes.
e)
No information on the instrument used by the inspector..
File No. 8 Licensee:
Trustees of Dartmouth College City, State:
Hanover, NH License Number:
382R Inspection Priority:
1 Lead Inspector:
M. Iannaccone/D. O'Dowd Type of Inspection:
Initial Inspection Date:
5/19/94 Issuance Date:
6/17/94 Program Code / Type:
E - Irradiator Greater than 10,000 Ci Comments:
a)
No documentation in narrative report of reviewing the licensee's i
ALARA program and Committee minutes.
b)
Good to mention in letter that using the irradiator for uses other than authorized uses is prohibited.
c)
Report gives full information on instrumentation used by the inspector, i
d
New Hampshire E-5 File No. 9 Licensee:
Donald F. Mayo, PE City, State:
Bow, NH License Number:
323R Inspection Priority:
3 Lead Inspector:
D. Russell Type of Inspection:
Routine Inspection Date:
3/15/93 Issuance Date:
3/23/93 Program Code / Type:
D(2) - Portable Gauges Comments:
a)
No record of independent measurements by the inspector.
b)
Labelling (of transport case), security, and transfer / shipping not addressed on field note form.
c)
Violation D not cited well.
Needs more specifics (dates, exchange frequency, etc.) in the " contrary to" paragrapt..
i d)
Good to address repeat nature of the violations.
l 1
1
APPENDIX F INCIDENT FILES REVIEWED File No. I Licensee:
Atlantic Testing Labs License No.
296R Summary of Incident:
Allegation that unauthorized personnel were ordered to clean source rod of portable gauge Comment:
State took prompt action to investigate allegation:
requested police investigation; held management conference; and issued emergency order to suspend license. Case still open.
File No. 2 Licensee:
none License No.
Summary of Incident:
Caller complained that truck parked in adjacent lot had radioactive materials placards.
Investigation revealed someone (possibly pranksters) had turned hazardous materials sign with radioactive' materials warning side out.
Comment:
Good follow up. State immediately called everyone involved and determined there was little likelihood of the presence of radioactive materials.
State followed up with on-site survey and commitment by truck owner to make sure signs stayed properly posted.
File No. 3 Licensee:
Heynen Teale Engineers, Inc.
License No.
353R Summary of Incident:
Truck ran over moisture density gauge, damaging it severely; however, source remained intact.
Site secured until BRH inspector arrived, surveyed area for contamination, and approved removal to licensee's facility.
Comment:
None.
State took correct action; properly reported to NRC.
File No. 4 Licensee:
Soils Engineering License No.
264R Summary of Incident:
Portable moisture density gauge run over by vibrating roller.
Source remained in shielded housing. After surveys by BRH inspector verified source housing was not breached, the source was returned to Troxler.
Comment:
None.
State took correct action; properly reported to NRC.
New Hampshire F-2 i
File No. 5 Licensee:
Dartmouth College License No.
276R Summary of Incident:
Lost shipment of 5 mci S-35:
Shipment logged in and placed in hall for pick up by user.
Janitorial staff assumed it was a used container and sent it to hospital trash disposal area. Material not found; assumed to be incinerated or compacted and buried.
Comment:
None. State has verified licensee has taken prompt and effective action to prevent similar mishaps in the future.