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Procedures for Recognizing, Monitoring, and Terminating Certification Process of Specialty Boards

Background

On March 30, 2005, the U.S. Nuclear Regulatory Commission (NRC) published the final rule, Title 10 of the Code of Federal Regulations (10 CFR) Part 35, "Medical Use of Byproduct Material—Recognition of Specialty Boards," providing, among other things, the criteria specialty boards have to meet before they can be recognized by NRC or the Agreement States (Federal Register (FR) 70 FR 16336-16367).   The procedures for recognizing specialty boards are provided below.  All boards, including those whose certification processes were recognized under the previous rule, were required to apply for recognition, so that the NRC could make a clear regulatory determination that all listed board certifications met the relevant criteria in the revised regulations, as required by the Commission in Staff Requirements Memorandum (SRM)-02-0194.

These procedures address:  (1) listing the boards meeting the regulatory criteria on the NRC's Web site (Medical Uses Licensee Toolkit); (2) adding and removing specialty boards to the recognized listing; and (3) assessing whether the board examinations adequately assess such knowledge/skills when a medical event may have been due to inadequate radiation safety training.   (SRM-02-0194, dated February 12, 2003, and SRM-03-0145, dated October 9, 2003.)

Procedures

The following describes the specialty board application process and how NRC staff (and Agreement States) will evaluate these applications.   The application evaluation will determine if the specialty board's certification processes satisfy the requirements for recognition by the NRC.   It also describes methods for processing these applications and monitoring the status of recognized board certifications.  Finally, it includes posting the recognized board certifications on the Medical Uses Licensee Toolkit and posting termination dates.

Applications for Recognition of Specialty Board Certifications

1. A specialty board requesting recognition should provide, via letter (on its letterhead), a list of sections in 10 CFR Part 35 for which the board wishes to have its certification process(es) recognized.

a.  The letter should include a clear description of the board's requirements for certification.  The boards' requirements should include a statement that prior to taking the board certification examination, candidates must complete the requirements for training and experience (T&E) required by the section(s) applicable to the type of certification, for which the board is seeking recognition.

If the board permits candidates to complete the board certification examination before the candidate completes the T&E criteria, the board should explain how the examination assesses knowledge and competency required in 10 CFR Part 35 for that specialty.

b.  The letter should provide information explaining how the examinations administered by the board assess competency in radiation safety.

c.  The letter on the board's letterhead should be dated and signed by the chief executive officer of the board, or designee.

d.  If the specialty board posts its requirements for certification on the Internet, the board should also provide the Web site address.

e.  The board should indicate when the certification program being described for recognition was established (i.e., became effective).  The board should also specify the length of time for which a certification is valid.

Note: Diplomats of the board who, prior to recognition of the board, met the requirements of the program described for recognition can be considered for approval as Authorized Medical Physicists (AMPs), Authorized Nuclear Pharmacists (ANPs), Authorized Users (AUs), or Radiation Safety Officers (RSOs) via the board certification pathway.

These individuals must meet all the requirements required by NRC for board's certification process recognition and the board must issue them a certificate identical to one submitted to the NRC as evidence that the process meets NRC's requirements for recognition.

f. If the certification is conditional on maintaining a certain level of additional T&E, then the board should describe how NRC and the Agreement States will determine if the individual is still board certified. If any special terms or phrases are used to describe the individuals certification status, these should be provided and defined.

g.  The letter should include a copy of the certificate(s) with any special terms or phrases that must appear on the certificate(s) and a "Draft" or "Sample" watermark across the text of each certificate(s).

2.  Once the specialty boards' applications are received, the NRC staff will evaluate the procedures and requirements of specialty boards for conferring certifications to determine if they are in accordance with the criteria established in the applicable sections of subparts B and D through H of 10 CFR Part 35 for NRC recognition of specialty board certifications.  The requirements for recognition of a board's certification for RSOs appear in § 35.50(a), for AMPs in § 35.51(a), for ANPs in § 35.55(a), and for various classes of AUs in §§ 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a) and 35.690(a).  Staff should consult with the Advisory Committee on Medical Uses of Isotopes (ACMUI) when needed. 

3.  When the board's certification process meets the appropriate set of requirements for NRC recognition, the NRC staff will notify the board of its finding via letter and add that board certification to the list of recognized board certifications appearing on the Medical Uses Licensee Toolkit.  The information posted on the Medical Uses Licensee Toolkit will include the dates for which the board's certification process is recognized, any special terms or phrases that must appear on the certificate, and a sample copy of the board certificate.  If the certification is conditional on maintaining a level of additional T&E, then the information posted will contain a copy of the terms used to indicate the individuals' certification status and a definition for each term.

4.  If a board's certification process does not meet the requirements in 10 CFR Part 35, or if there is not enough information to make that determination, the board will be notified and requested to provide additional information via letter. 

5.  If no additional information is received from the board, an abandonment letter will be sent to the board.

6.  If after additional information is received, the board's certification process still cannot meet the applicable criteria in 10 CFR Part 35, NRC staff will notify the board of the denial of recognition via letter.  The NRC staff will also notify the Agreement States, via letter, of the name of the board and the date of denial. 

7.  Agreement States may also recognize the certification process(es) of specialty boards that meet the requirements in 10 CFR Part 35.  The T&E requirements, including those for board recognition, are Compatibility Category B because of their transboundary implications.  Please see "Review Summary Sheets for Regulation Adoption for New Agreement States/Programs (10 CFR 35)." 

8.  Specialty boards recognized by an Agreement State will also be listed on the Medical Uses Licensee Toolkit.  The listing will be annotated to indicate which Agreement State conducted the review. 

Note: Typically, the goal for NRC staff to complete a response is within 60 working days from the time all necessary information is received.  If no response is received after 30 days of submitting a request for additional information, the request from the specialty board will be voided.

Communications with Specialty Boards

1.  Communications between the NRC staff and specialty boards will be in writing, via letter.  Communications to the NRC from a specialty board are to be signed by a person authorized to speak for the board (i.e., its chief executive officer or designee) and mailed on board's letterhead to:

Director
Division of Materials Safety and State Agreements
Office of Federal and State Materials and Environmental
Management Programs
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001

Attention: Chief, Radioactive Materials Safety Branch, Mail Stop T-8E18

For delivery services requiring a street address, mail to:

Director
Division of Materials Safety and State Agreements
Office of Federal and State Materials and Environmental
Management Programs
U.S. Nuclear Regulatory Commission
11545 Rockville Pike
Rockville, MD 20852-2738

Attention: Chief, Radioactive Materials Safety Branch, Mail Stop T-8E18

2.  Communications include those sent to the NRC for the purpose of supplying information in support of an application.  Change in certification procedures, change in certificates, or other change that would affect recognition of the board's certification process(es) under 10 CFR Part 35 would also be included in these communications. 

a.  Letters from the board should acknowledge management's commitments to and responsibility for the completeness and accuracy of the information provided to the NRC.  

b.  Letters of recognition to boards will include a request that recognized boards notify the NRC, via letter, 6 months in advance, of: plans for becoming inactive or disbanding; changes to the board's name; the name of its specialty certifications, certification procedures and certificates that would affect the recognition of their certification processes.

3.  In accordance with § 2.390, "Public inspections, exemptions, requests for withholding," copies of all communications, including enclosures, will be made available electronically for public inspection in the NRC Public Document Room or from the NRC Agencywide Documents Access & Management System (ADAMS).  The board will be informed of these requirements in advance of submitting information and encouraged to not include any personal privacy or proprietary information in communications, to the extent possible, so that they can be made available to the public without redaction.  If the board includes personal privacy or proprietary information and the board has not followed the procedures specified in § 2.390(b), the NRC will return to the specialty board any communications containing personal privacy or proprietary information for resubmission.

Maintenance of Recognized Status

1.  In addition to the notification by the board of changes affecting NRC recognition of the board (see item 2.b, "Communications with Specialty Boards" section), the NRC staff will periodically request, from each board whose certification process(es) has (have) been recognized by the Commission, verification in writing that:  (1) it has not changed its name or the name of its specialty certifications; and (2) all changes in its certification procedures, including changes to certificates, that would affect the recognition of its certification(s) have been communicated to the NRC for review.  If a board does not respond, the NRC staff will investigate the matter.  The NRC staff requests to the boards for verifications will be via letter, at intervals not to exceed 5 years. 

2.  The NRC staff will evaluate the recognized board's Web site and current certificate for changes that could affect a recognition of the board's certification process(es) every 5 years, using the procedures outlined in the "Applications for Recognition of Specialty Board Certifications" section, and seek the advice of the ACMUI if necessary.  The NRC staff will determine if the board's certification procedures continue to meet the applicable criteria for recognition of board certifications, as established in §§ 35.50(a), 35.51(a), 35.55(a), 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a), and notify the board regarding its findings via letter. 

3.  The Agreement State which initially recognizes a board's certification process(es) will be responsible for determining that board's continued eligibility for recognition.

Procedures for Terminating Recognition of Specialty Boards

1.  Termination based on inadequate evaluation of radiation safety competency of candidates for certification:

a.  The NRC staff will monitor trends in medical events and escalated enforcement actions.  If a trend in medical events or escalated enforcement actions for a particular specialty is attributable to inadequate radiation safety competence, the staff will determine, in consultation with the ACMUI, if the trend is associated with a deficiency in the evaluation of the individuals' qualifications.  This deficiency must be traceable to inadequacies in a specialty board's certification process, including requirements for T&E related to radiation safety.  If the trend is determined to be attributable to inadequate radiation safety competence that is not identified through the certification process, the NRC staff will assess whether the examinations provided by the certifying board adequately assess the knowledge/skills reflected in the requirements for T&E related to recognition of the specialty board's certification process.

b.  If the NRC staff determines that changes in evaluation of the radiation safety competence of candidates for certification by a specialty board are necessary in order for the board to maintain recognition of its certification process(es), the board will be advised of this determination.  The NRC staff will send a request to the board to provide a description of any changes the board would propose to make, in order to maintain recognition of its certification processes by the NRC, and to identify reasons for disagreeing with NRC findings, if this is the case.  The NRC staff will use the procedures discussed under "Applications for Recognition of Specialty Board Certifications," item 1, as a guide in this process. 

c.  If the board fails to respond or if, after reviewing the board's response, changes to certification requirements are still necessary and the specialty board takes no action to address NRC's concerns, a date terminating recognition of that specialty board will be added to the Medical Uses Licensee Toolkit. 

d.  The Commission and the ACMUI will be informed of any decision by the NRC staff to terminate recognition of a board's certification. 

e.  The NRC will notify the board via letter that this action has been taken, and advise the board that it may supply new information for review by the NRC staff.  This information will be used to determine if the board's procedures are adequate to resolve NRC's concerns. 

f.  When a board's recognition is terminated by the NRC or an Agreement State due to an identified deficiency in its requirements for the certification process, the NRC staff will determine the date when the inadequacy developed, beyond which the certification will no longer be recognized.  That termination date will be posted on the Medical Uses Licensee Toolkit listing for that board's certification. 

g.  When a board's certification process is recognized by an Agreement State, that State shall be responsible for assessing inadequate evaluation of radiation safety competency of candidates for certification, for terminating recognition for that board's certification(s), and for notifying the NRC. 

2. Termination based on change in the certification process:

a.  If an instituted or proposed change in the certification process(es) of a recognized board may adversely affect the recognized status of the board's certification process(es), the board will be advised.  The board will be requested to provide information to support continuation of NRC recognition of the board's certification process(es) via letter.  The ACMUI will be informed of this determination and request for information.

b.  If the board fails to respond or if, after reviewing the board's response, changes to certification requirements are still necessary and the specialty board takes no action to address NRC's concerns, then that specialty board's certification(s) recognition will be terminated. 

c.  The board will be notified via letter of this action, and advised that it may supply new information to determine if its procedures are adequate to resolve NRC's concerns. 

d.  The Commission and the ACMUI will be informed of an NRC staff determination that a board's certification(s) recognition is to be terminated.  

e.  If a board is terminated by the NRC or an Agreement State due to inadequacy of its certification process requirements, the NRC staff will determine the date when the inadequacy developed, beyond which the certification will no longer be recognized.  That termination date will be posted on the Medical Uses Licensee Toolkit listing for that board. 

f.  When a board's certification process is recognized by an Agreement State, that State shall be responsible for assessing inadequate evaluation of radiation safety competency of candidates for certification, for terminating recognition for that board's certification(s), and for notifying the NRC. 

3.  Termination based on a board becoming inactive or disbanding:

a.  If the NRC staff becomes aware that a board has or intends to become inactive or disband, the staff will attempt to contact the board.  The NRC staff will request via letter that the board provides information confirming whether the board has become inactive or disbanded, or intends to become inactive or disband.  The NRC staff will request an explanation of why the change should not result in withdrawal of NRC recognition of the board's certification process(es). 

b.  If the board fails to respond or if, after reviewing the board's response, the NRC still believes that the board has changed its status and that this change should result in withdrawal of NRC's recognition of the board's certification process(es), then a date terminating recognition of certification will be added to NRC's list of recognized board certifications.  

c.  The Commission and the ACMUI will be informed of a staff decision to terminate recognition of a board's certification. 

d.  The NRC will notify the board via letter that this action has been taken, and advise the board that it may supply new information to determine if its procedures are adequate to resolve NRC's concerns.

e.  If a board's certification recognition is terminated by the NRC or an Agreement State due to the board becoming inactive or disbanding, the NRC staff will determine the effective date of this change in status and the date when the certification is no longer to be recognized.  Information about the dates for which the board's certification was recognized and the termination date will be posted on the Medical Uses Licensee Toolkit. 

f.  When a board is granted recognition by an Agreement State, that State shall be responsible for monitoring the status of the board, for taking action to terminate recognition of a board's certification(s) if the board becomes inactive or disbands, and for notifying the NRC.

Evaluation of Training and Experience - “Outdated” Certifications and Certificates

If an individual holds a certification from a board for which the NRC or an Agreement State terminates recognition of the board's certification process, the certification will be considered valid if it was granted during the time interval that the board's certification process was recognized.  The NRC will annotate the listing of board certifications on the Medical Uses Licensee Toolkit to indicate the effective dates of recognition of board certifications, including the date(s) of termination and date(s) through which certifications were recognized.  If the certificate changes, the listing will also indicate the length(s) of time for which the particular board certificate is valid.  

Note: The recentness of training requirements contained in 10 CFR 35.59 must also be satisfied. The NRC staff will identify, from the group certified by a specialty board, the individuals that meet NRC's regulations for recognition.

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Page Last Reviewed/Updated Friday, September 19, 2014