The Minutes of the Radiation Protection Advisory Committee Meeting
Rachel Carson State Office Building, Harrisburg, PA
May 28, 2003
The Meeting was called to order at 9:01 a.m. Chairman Joe Och presided.
Members in Attendance:
Mr. Joseph Och, (Chairperson), Mr. John Keklak, Ms. Jane Fisher, Dr. John Pammer,
Dr. Douglas Eggli, Mr. Vincent Roding, Mr. Jerry Rosen, Mr. John Miller, Mr. Robert
Forrest alternate for Dr. Darryl Berry, Dr. Robert Meals, and Ms. Janice Wirth.
Dr. Darryl Berry, Dr. Peter Bloch, Dr. Gary Conover, Dr. Robert Christman, and Dr.
Bureau of Radiation Protection Representatives:
Acting Deputy Secretary for Air Recycling and Radiation Protection Mr. David Allard;
Acting Director for the Bureau of Radiation Protection Mr. Rich Janati; Div. of Radiation
Control Chief, Mr. L. Ray Urciuolo; Chief, X-ray Section, Mr. Stephen Williams; Western
Area Program Manager, Mr. James Yusko; Central Area Program Manager, Mr. James
Kopenhaver; Radiation Protection Program Supervisor, Mr. Dwight Shearer; Radiation
Protection Program Supervisor, Mr. Terry Derstine; Program Analyst, Mr. Ben Seiber;
Ms. Marylou Barton, Office of Chief Counsel and Mr. Joe Sieber and Mr. Bob Diehl from
the Policy Office.
Mr. Och noted that the meeting materials were distributed to the Committee fewer than
two weeks prior to the meeting contrary to the committee’s bylaws. The Chairman
added that the distributed agenda would not be followed. The minutes from the meeting
on October 24, 2002 were adopted by acclamation. Mr. Och expressed concern over
the minutes from the meeting on November 20, 2002. He proposed replacing the first
paragraph under “Continued Discussion of Proposed Rulemaking from 10-24-2002” with
the following four paragraphs:
Before beginning the meeting, Mr. Och posed a question to those present;
Committee members, as well as representatives of the Department. Mr. Och
noted that the RPAC’s charge, according to the bylaws, is to “review draft and
proposed regulations and provide advice to the Department.” He elaborated by
describing the operations of some other advisory committees with which he was
familiar. He stated that in most cases, a proposal for regulatory revision is
submitted to the committee, which discusses and deliberates, then issues its
recommendation to the applicable agency.
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He noted that the operation of the RPAC has been different. Here members of
the Department are routinely actively involved in the discussion. In fact,
invariably any decision reached at the meeting represents the consensus of both
RPAC members and guests, which have only consisted of Department
Mr. Och noted that this has resulted in lively, sometimes heated, debate. But,
this debate has produced decisions which are approved by all participating. He
stated that this reality obviates any further action by either party. For if the
RPAC, or the Department, is free to change the consensus decision after the
fact, it trivializes the decision. The above was said to determine the
Department’s willingness to accept decisions arrived at in RPAC meetings as
final. If the Department retained the privilege of unilaterally revising mutually
produced decisions, there was little sense in allowing that participation. Mr. Och
The response was unanimous. All present lauded the systems in which RPAC
currently operates. All admitted that sometimes tempers were raised, but the
discussions were valuable and all felt the situation should remain as it currently
was. Mr. Och stressed that this meant that any mutually agreed decision was
then Final and could not be altered unilaterally by either party.
Mr. Forrest moved to amend the minutes from the meeting on October 24, 2002
Mr. Rosen asked what happens to the minutes. Mr. Urciuolo responded that portions of
the minutes that relate to a regulation package are forwarded to the EQB along with the
regulation package. Mr. Allard added that minutes from all advisory committees are
reviewed by the Executive Staff of the Department. Mr. Rosen expressed concern that
the minutes consistently reflect the position of the Department after the fact and not the
position of RPAC. Mr. Och voiced his willingness to limit the Department’s involvement
in RPAC meetings if the Department continues to change its position after a mutual
decision has been reached in an RPAC meeting. Mr. Allard asked for significant
examples of this. Mr. Och responded that he could think of examples, but he was not
prepared to discuss them at this time. Mr. Keklak did supply the example of the
qualified expert discussion. He pointed out that the Department did not initially
recognize the RPAC language and position. Mr. Rosen expressed concern that by the
time minutes are corrected at the next meeting, those comments have already gone to
EQB and the corrected minutes then become irrelevant. Dr. Eggli expressed concern
that the minutes can misrepresent the advice of the committee and that the Department
needs to clearly state when it is acting contrary to the advice of the Committee.
Furthermore, it would be useful to clearly document the RPAC position and compare
and contrast it to the Department’s position. Mr. Allard committed to distributing a draft
of the minutes to the committee members three to four weeks after the meeting as well
as documenting the Committee’s dissenting opinions. Mr. Och questioned Mr. Urciuolo
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as to the feasibility of this. Mr. Urciuolo responded that it is possible with assistance
from Bureau staff. Mr. Och then requested that Mr. Urciuolo distribute minutes to the
Committee within four weeks of the meeting.
Mr. Och asked if the Committee disagrees with a regulation package, in part or as a
whole, would the offending language be removed. Mr. Allard answered in the negative
but added that the comment and response process associated with the regulation
approval process takes care of this. Mr. Rosen stated that from his experience there is
a difference in how a public comment is handled versus an RPAC comment. Mr. Och
agreed and said the Committee advice can be ignored. Mr. Allard countered that often
there is further reflection and new information can be reason for modifying a proposed
regulation; it is not necessarily that the Committee’s comments are being ignored.
Ms. Fisher stated that she had heard the phrase ‘just an advisory committee’ and that it
hurts the morale of the Committee.
Mr. Rosen said he sees a difference between recommendation and agreement. He
went on to say the Committee often leaves a meeting thinking it has come to an
agreement with the Department but it often seems that the Department thinks of it as
merely a recommendation. He went on to say that, if we leave this room with an
agreement but then the Department changes it, then what is the point. Mr. Allard said
we do make agreements.
Ms. Barton offered that there is a checklist for who regulation package information is
distributed to. Dr. Eggli expressed concern that the Chairman should not have to look
for regulation package changes, the Department should tell him.
Mr. Och requested that draft minutes from each meeting be distributed to the entire
Committee as well as draft products of all things changed by agreements made during a
Mr. Och and Ms. Fisher asked what happens to guidance in the Bureau. How much
change occurs? These changes need to be communicated to the Committee. How will
this be done? Mr. Och continued, If the Department changes anything that is agreed to
in RPAC between the Committee and the Bureau, will the Bureau document and
communicate it to RPAC? Mr. Allard responded in the affirmative.
It was suggested that when the RPAC writes its recommendation on a document,
policy, etc. that it include phrases such as ‘agree in whole’, ‘ agree in part’, and ‘except
the following’, thereby clearly indicating its opinion.
Mr. Och again stated that draft minutes, draft regulation packages, and subsequent
changes by the Bureau or Department will be distributed to the Committee within one
month of a meeting. Mr. Allard added that if this material requires Executive staff
approval it might add a week.
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Review of Current BRP Activities (Mr. Allard):
Nicholas A. DiPasquale was recently named Deputy Secretary for Air, Recycling, and
Radiation Protection. He will start Monday, June 2, 2003. Mr. Rich Janati will remain
Acting Bureau Director until mid-June.
The current threat level is orange. The Governor has ordered National Guard Troops
and State Police forces to once again guard the five nuclear power plants in the
Commonwealth. Emergency Preparedness drills and exercises are moving forward.
Materials – Accelerator applications are still coming in and completeness reviews are
ongoing. Joint central office/regional office technical reviews are beginning. The non-
medical accelerator application packages will be going out shortly. The solid waste
monitoring program is moving ahead.
Radon – The Department may request that RPAC look at radon in schools and other
radon issues. Mr. Och interjected that if this is to happen the Committee will need to
bring in someone who is more knowledgeable in this area.
Decommissioning – The Decommissioning Division is operating at a high level of
activity right now. The main reason for this is the Chapter 7 bankruptcy filing of
PermaGrain Products, Inc. (Quehanna). The Bureau is now the NRC licensee for the
legacy contamination at the site. The Department has received $7 million from the
Federal Government through DOE (The Department of Energy). This money will be
used to speed up the decommissioning activity at the Quehanna site. EPA will remove
the cobalt-60 at the site under an emergency removal action of CERCLA (The
Comprehensive Environmental Response, Compensation, and Liability Act commonly
known as Superfund). It is the hope of the Acting Deputy Secretary (Mr. Allard) that the
final status survey will be underway by the end calendar year 2003.
Progress toward Agreement State – status quo, nothing new to report.
Mr. Allard concluded this portion by speaking to and praising the ability and experience
of the DEP Acting Secretary Katie McGinty.
Mr. Och suggested the Committee take a few moments during the break to review the
proposed Medical X-ray Procedures Operator Training Guide and consider rescheduling
the next meeting date.
Ms. Barton handed out a document issued by the Independent Regulatory Review
Commission entitled The Regulatory Review Process in Pennsylvania upon returning
from the break. This handout was intended to help avoid any future confusion the
Committee may have regarding the regulation package approval process discussed
earlier in the day.
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RPAC suggested risk based training guidance on Section 221.11(b) and
corresponding Draft Medical X-ray Procedures Operator Training Guide
Dr. Pammer questioned “4 hours” on page 3, section B. He asked if this supersedes a
state board certification. Ms. Barton responded that regulations trump this guidance.
A significant discussion ensued. Mr. Och noted there should be a provision for an
acceptable means of verifying initial high-risk training requirements (this would be
IA1(a)(2). He suggested the Department maintain a list of accepted boards that can be
used for this purpose. The Chairman will provide a draft of the RPAC recommendation
to the Bureau after it is circulated with the subcommittee. Mr. Och committed to having
this draft to the subcommittee by July. A summary of the discussed changes follows.
I. Training Requirements
A. High Risk Procedures:
1. All operators performing high-risk procedures shall undergo the following
training prior to operating any x-ray unit:
a. Initial training
1) All operators beginning practice in high-risk procedures will
have to demonstrate at least eight (8) hours of training. This
training shall include topics of imaging, patient and personnel
radiation safety, regulations, radiation risk and radiobiology
(per Appendix A section II).
2) Acceptable means of verifying initial training for high-risk
b. Annual Continuing training
1) One (1) hour of training annually. Competency verification of
at least one (1) hour CE equivalent in to include radiation
safety / radiation biology related topics only (per Appendix A
2) Acceptable means of completing annual continuing education
a. CME / CEU approved seminar
b. In-service training, refresher in required topics
d. Demonstrated competence
B. Non-High Risk Procedures:
1. All operators performing non-high risk procedures shall undergo the
following training prior to operating any x-ray unit:
a. Initial training
1) All operators beginning practice in non high-risk procedures
will have to demonstrate at least four (4) hours of training.
This training shall include the topics of imaging, patient and
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personnel radiation safety, regulation, etc. (per Appendix A
b. Annual Continuing training
1) One (1) hour of training biannually. Competency verification
of at least one (1) hour CE equivalent in to include radiation
safety / biology related topics only (per Appendix A section
2) Acceptable means of completing annual continuing education
a. Continued certification / registration by an accepted
b. CME / CEU approved seminar
c. In-service training, refresher in required topics
e. Demonstrated competence
II. Acceptable means of completing annual continuing education requirement:
A. Continued certification / registration by an accepted
B. CME / CEU approved seminar
C. In-service training, refresher in required topics
E. Demonstrated competence
Documentation for any acceptable means of completing annual or bi-annual continuing
training education requirements shall indicate either the certificate of attendance of the
CME / CEU approved seminar and in-service training, the testing requirements (including
the passing criteria), or the notes and discussions from the observations.
II. DETERMINATION OF COMPETENCE
The registrant shall ensure that training on the subjects listed in Appendix A has been
conducted. The individual shall be trained and competent in the general operation of
the x-ray equipment, and in the following subject areas, as applicable to the
procedure(s) performed and the specific equipment utilized.
(1) Basic Properties of Radiation
(2) Units of Measurement
(3) Sources of Radiation Exposure
(4) Methods of Radiation Protection
(5) Biological Effects of Radiation Exposure
(6) X-ray Equipment
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(7) Imaging Recording and Processing
(8) Patient Exposure and Positioning
(10) Quality Assurance Program
There was a further discussion about the definitions, more specifically the subtle
differences between high-risk versus non-high-risk, invasive versus noninvasive, and
time limit versus beam-on time. How to identify high risk procedures (relative to the
likliehood of exceeding 200R). Inserting the term ‘likely to exceed’ was mentioned as a
possible solution. Mr. Och committed to providing a draft re-write by July.
Mr. Shearer questioned the content requirements of the training, the likelihood of this
content being rotated, and mechanics of an inspecting for compliance with this
guidance. Ms. Fisher had previously stated that credential tracking is possible as it is
most likely already done by the facility’s Human Resources department. Several of the
Committee members noted that retrieving this information from HR would make
inspections more difficult.
Bylaws discussion – Draft department standard (Mr. Rosen’s handout)
Mr. Rosen lead the discussion as a report of a subcommittee of one assigned by the
chair to review the bylaws. Mr. Rosen began by saying that both he and the
Department, working independently, developed remarkably similar drafts. The
requirement to have the by-laws approved by the Department came up which led to the
question of whether the Committee can vote to have the by-laws the way they want.
By-laws must be compatible with Department policy. Mr. Allard noted that if a dispute
that could not be resolved were to arise, the Department has the power to dissolve the
current RPAC and reconstitute it under new bylaws. He quickly added that he would
not want to resort to that. Mr. Rosen asked if there was a list of representative
organizations from which members are chosen. Mr. Urciuolo responded that there is
not and that organizations and members are chosen at the discretion of the
Department. Membership referrals may come from the Department, the Committee or
from the outside directly to the Secretary. It is generally agreed that a three-year term
limit is too short and that five-year term limits would be more reasonable. The question
then arose of how many times could a member be reaffirmed/reappointed. The answer
came to be indefinitely, provided there is support from either the Department or the
Committee. In order to maintain continuity and momentum it was suggested that only a
fraction of the membership be reaffirmed in any year.
The question of which organizations should be represented on the Committee came up
again. Ms. Barton noted that in addition to members who represent a specific interest,
the Act allows for the committee to have more than one member of the general public. It
was suggested that the word organization be replaced with either constituency or
stakeholder in the bylaws and that “at large” membership be made available. Later
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replacing the word organization was retracted. The following language was suggested
to be added regarding membership:
The Bureau shall solicit nominations from stakeholders, constituency
groups, and professional organizations such as, but not limited to…
The suggestion was made that if a member does not attend a meeting that the
organization they represent should be notified. Who should do the notification was not
discussed. It was also suggested that there be at least one member-at-large position
on the committee that represents no particular interest and has no alternate.
Mr. Keklak suggested the addition of an Article XIV dealing with conflict of interest. He
proposed that no DEP employees be allowed to be a member of the Committee. Mr.
Allard countered that the possibility of the Radiation Protection Bureau Director, or
his/her representative, being an ex-officio member be left open.
Mr. Urciuolo suggested adding language in Article IV that would allow alternates to be
reimbursed for the travel expenses.
Mr. Och moved that alternates should be entitled to vote. Mr. Miller seconded this
motion. Ms. Barton warned that this is contrary to the Policy Office position and the
Committee should not be surprised if there is resistance on this point. Mr. Urciuolo
suggested teleconferencing as an option that would allow members to attend without
concern over the voting rights of alternates.
The proposed addition of the position of vice-chairperson was well received.
Mr. Rosen suggested adding the following language to Article VII:
The committee secretary will provide a report to the committee on the final
disposition of the recommendations of the Committee. This report will
include the Department’s actions on the Committee’s recommendations, a
copy of the materials submitted to the Environmental Quality Board on
those recommendations, and the Board’s actions on the materials
submitted. If the Committee’s recommendations were not accepted by
either the Department or Board, the reasons for the rejection will be
included in the report.
The Committee will be kept apprised of the status of regulatory changes;
e.g., when the material is forwarded to the Environmental Quality Board
and when the regulations are published in the Pennsylvania Bulletin.
Notifications may be made either by email or surface mail.
The suggestion was made to change Article IX to read that a quorum shall consist of
‘six voting members’.
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The Committee does not agree with the department proposal in Article XI to schedule
the time slot for members of the public to address the Committee at the beginning of
Committee meetings. The Department picked that time rather than the end of the
meeting because there was uncertainty when the meetings end. However, the chair
may open the floor for comments at any time.
Positron Emission Tomography (P.E.T.) scan training and experience
requirements (Mr. Forrest’s handout)
Mr. Forrest expressed his opinion that the Department is asking for more than what10
CFR Part 35 requires. He asked what additional requirements does the Department
have for approving authorized users of PET pharmaceuticals. Mr. Urciuolo responded
that participation in 10 studies is required. Dr. Eggli cautioned that the Department’s
requirements can only focus on safety, not the practice of medicine. Mr. Keklak added
that P.E.T. is no longer emerging technology and should not be subject to strict
regulation. Mr. Urciuolo mentioned it was always the Bureau’s intention to eventually
put P.E.T under group authorization in 10 CFR 35.200. The Committee asked what the
timeline is for such a shift. The Bureau indicated a commitment could be made to
amend all licenses this year and clean up language not consistent with the new Part 35.
It was pointed out that the implementation rule in new Part 35 makes the existence of
contradictory text in licenses irrelevant. The Bureau is aware of the double standard
created by the new Part 35 and has reservations about the even larger impact of
opening all group 200 including PET to any authorized user -- even cardiologists. Dr.
Eggli said that despite similar personal reservations about the impact on cardiologists, it
was more important to apply the regulations uniformly and consistently. Dr. Eggli made
a motion and Mr. Forrest seconded it that the Department regulations be no more
restrictive than Part 35.
The next meeting of the Radiation Protection Advisory Committee has been
rescheduled from Wednesday, October 1, 2003 to Wednesday, September 24, 2003.
The agenda item “Proposed Guidance on implementing RIS 2002-06 modifying
dosimetry reporting when X-ray protective aprons are worn” (includes RPAC position on
Webster formula) was tabled until the next Committee meeting.
The Committee requested a timeline for the process of the proposed regulation
package. Mr. Urciuolo responded that the package is scheduled to go before the EQB
on 7/15/03 and may be back to the RPAC for its next (9/24/03) meeting if all goes well.
Mr. Keklak requested that the Committee be notified of the progress of this package at
each step in the process.
Mr. Roding motioned to adjourn the meeting. The meeting adjourned at 3:02 PM.
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