Legislature(1997 - 1998)
05/07/1998 04:30 PM House FIN
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* first hearing in first committee of referral
+ teleconferenced
= bill was previously heard/scheduled
+ teleconferenced
= bill was previously heard/scheduled
SENATE BILL NO. 160
"An Act relating to registration, inspection, and
testing relating to radiological equipment in dentists'
offices."
MEL KROGSENG, STAFF, SENATOR TAYLOR testified in support of
SB 160 on behalf of the sponsor, Senator Taylor. She noted
that SB 160 changes the procedures for inspecting and
registering dental radiological equipment. She maintained
that on-site inspections by the Department of Health and
Social Services are unnecessary because the incidence of x-
ray overexposure is so insignificant as to be non-existent.
Some states do not have a requirement for registration or
inspection of dental radiological equipment.
Ms. Krogseng observed that SB 160 would transfer the
registration of dental radiological equipment to the Board
of Dentistry. Inspection activities would be done by the
private sector. The owner or lessee would be responsible
for providing the Board with documentation showing that the
equipment is registered and has been inspected within the
past fives years.
SB 160 would place the registration of dental radiological
equipment with the Board of Dentistry. The owner of the
equipment will be responsible for providing documentation to
the Board that the equipment is registered and has been
inspected within the past five years. The Board will
establish inspection criteria.
Ms. Krogseng stressed that if a dentist uses unregistered or
uninspected equipment, they will be subject to a civil
penalty in the form of a fine, levied by the Board, not to
exceed $5000 for each offense.
Ms. Krogseng maintained that some dentist have gone as long
as seven to ten years without inspections due to a lack of
qualified inspectors. She stressed that dentist want to
have inspections. She asserted that the legislation would
make inspections and corrections more efficient. She
observed that the Alaskan Dental Society supports the
legislation. She provided members with Amendment 1.
Amendment 1 would include completion of a United States
Department of Defense biomedical equipment technician's
course and the International Certification Commission for
Clinical Engineers and Biomedical Technology as allowable
qualifications for inspectors (copy on file).
Representative Martin expressed concern with the need for
the legislation and questioned if dentist will support the
legislation through fees. Ms. Krogseng clarified that the
program would be revenue neutral. Fees would offset the
cost. The Board of Dentistry would only have an
administrative function. The Board would receive and track
forms submitted by private inspectors. There are a total of
241 dentist facilities in Alaska. There are a number of
private sector persons that would qualify as inspectors.
Representative Martin asked what insurance the public would
have that some objective overview was performed. He
maintained that oversight is needed outside of the dentistry
profession.
Ms. Krogseng maintained that the risk with dental equipment
is miniscule. She observed that equipment must meet federal
standards.
DR. WOLLER, PRESIDENT ALASKA DENTAL SOCIETY, FAIRBANKS
testified via teleconference in support of the legislation.
He stressed that the risk is minimal. The people that do
the actual calibration will monitor equipment and the Board
would provide oversight. He noted that there was a 12-year
period where his equipment was not inspected. He maintained
that six feet of air absorbs all radiation. He explained
that the Association recommends that inspections be once
every five years. This is consistent with practices in
other states. Manufactures recommend every year.
Representative Davies asked for more information regarding
federal regulations. Dr. Woller noted that there are
federal regulations regarding shielding and distance between
radiation. There are no federal permits.
CATHERINE REARDON, DIRECTOR, DIVISION OF OCCUPATIONAL
LICENSING, DEPARTMENT OF COMMERCE AND ECONOMIC DEVELOPMENT
provided information regarding SB 160. She observed that
the Dental Board did not request the responsibility. The
Dental Board was opposed to the original legislation. The
Department of Commerce and Economic Development is concerned
that the legislation would result in duplication of
expertise and effort. The Department of Health and Social
Services is knowledgeable about radiation. The Dental Board
and the Department of Commerce and Economic Development are
not knowledgeable about radiation. The Department of
Commerce and Economic Development is concerned about the
availability of potential inspectors and the potential cost.
Each owner would be responsible for inspections. The charge
could be substantial in rural Alaska.
KATE COLEMAN, RADIOLOGY HEALTH SPECIALIST, DEPARTMENT OF
HEALTH AND SOCIAL SERVICES testified in opposition to SB
160. Ms. Coleman is one of two radiological health
specialists employed by Alaska's Department of Health and
Social Services. She expressed concerns that the
legislation would diminish the capacity of public health by
diluting the regulation of dental x-ray. On the
international radiation protection scene, the International
Commission of Radiation Protection would like to lower the
exposure limit for occupationally exposed radiation workers.
The bill would remove from occupationally exposed dental
workers government regulation aimed at keeping their
radiation exposures to as low as reasonably achievable.
Ms. Coleman noted that questions have been raised about the
health effects and risk related to dental x-ray exposure.
There is an indication of risk in the technical paper of Dr.
Smart Smith of the UCLA School of Dentistry. "While the risk
from dental radiography is certainly small in terms of other
risks we readily assume during our daily lives such as
driving, smoking, eating fatty food, there is no basis to
assume it is zero .... prudence suggests we should be
cautious because of the large numbers of people exposed to
dental radiography... Recent studies suggest the lifetime
cancer risk from exposure to low levels of ionizing
radiation may be greater than previously estimated .... The
International Commission for Radiation Protection data shows
that the estimated risk has increased four-fold. Cancers
other than leukemia typically start to appear about 10 years
following exposure and remain in excess for the lifetime of
the exposed individuals." Citing specific cancers, Dr. White
notes "an association with leukemia, the risk to children
being greater. Thyroid cancers increase in humans following
exposure to ionizing radiation. About 10% of individuals
with such cancers die from their disease. A case-control
study has shown an association between brain cancer and
previous medical or dental radiography. Several studies have
shown an association between tumors of the salivary glands
and dental radiography." As long as there is a risk it needs
to be monitored the Department of Health and Social Services
has responsibility for protecting the public health.
Ms. Coleman maintained that there is an absence of checks
and balances. She maintained that the bill presents a
conflict of interest and the credentials for inspectors are
lax. "For instance, are they qualified to operate radiation-
measuring equipment, to calculate skin dose, to evaluate
film quality, perform shielding calculations and scatter
radiation measurements. A certification program for the
inspectors administered by the state should be in place to
keep the standards high."
Ms. Coleman asked who would design the inspection
procedures? Will the Board be taking on responsibilities
for physics and engineering? What role will the Board have
in regulating radionuclides included in Section
08.36.075(g)?"
Ms. Coleman observed that the bill does not include
radiation protection, film processing, nor x-ray operator
competence. "Yet, the majority of problems in dental
radiography are a result of film processing and operator
error. Frequently, in an attempt to improve film quality, an
inexperienced operator will increase the radiation exposure
rather than use appropriate film processing".
Ms. Coleman asserted that the bill creates duplicate
functions between two state agencies. "The type of
organization proposed by this bill is unusual by any state's
standards since the professional board is so distant from
the technical aspects of radiation protection. Alaska, like
many other states, struggles to maintain a sufficiently
trained supply of personnel to meet the public health needs
of the State. It is wasteful to establish parallel lines of
expertise in two separate departments".
Ms. Coleman pointed out that AS 18.60.475(a)(7) authorizes
the Department of Health and Social Services to "contract
with other State agencies to assist them in performing
functions that require expertise in determining and reducing
the hazards of radiation." She stressed that this
authorization is cognizant of the unique qualifications
necessary to understand and satisfactorily implement a
responsible radiation control program. "It is clearly
designed to assure that this relatively rare expertise is
shared with other parts of the government. It seems wasteful
to depart from that philosophy and establish duplicative
expertise in another department".
Ms. Coleman questioned if there would be sufficient
resources available statewide to support this function in
Alaska. "Passage of this bill would serve to provide less
protection for Alaskan citizens. Already thin resources will
be spread less effectively."
Representative Mulder questioned how thin resources would be
spread more thinly. Ms. Coleman explained that the
Department of Environmental Conservation, Department of
Labor, Department of Health and Social Services and
Department of Commerce and Economic Development would all be
performing radiation work. Representative Mulder asked how
Dr. Woller's concerns regarding the frequency of inspections
would be addressed. Ms. Coleman clarified that there is
currently one full-time and one quarter-time inspector
working with the Department of Health and Social Services.
She maintained that all facilities would be inspected every
three years. She stressed that an additional inspector was
hired in May 1998.
Representative Mulder observed that the Dental Association
supports the legislation. The Dental Board has not taken a
formal position on the proposed committee substitute.
In response to a question by Representative Martin, Ms.
Coleman clarified that the legislation would remove the
responsibility for inspections from the Department of Health
and Social Services. She added that dentist have always had
the option of hiring technicians to service their equipment.
She emphasized that health specialists do not do the same
work as technicians.
Representative Martin expressed concern with the transfer to
the Department of Commerce and Economic Development. He
asked if the Dental Board would rubber-stamp the
certification. Ms. Reardon observed that the Dental Board
would contact owners to make sure that they are registered
and have submitted their certification. Violations would be
charged.
Representative Martin asked if the Dental Board has the
ability to oversee medical specialists. Ms. Reardon noted
that the Department of Commerce and Economic Development has
staff that assists medical boards. Staff is not
knowledgeable on health care or medical issues. A clerk
position would be hired to process paper. There are
approximately 500 pieces of equipment to register. The
Board will need to formulate regulations.
Representative Davies asked for further clarification in
regards to the qualifications of a health specialist and a
medical electronic technician. He noted that an inspector
would not need a degree. They could have four years of
experience. Ms. Coleman explained that a health specialist
is trained in radiation protection. They are not trained in
electrical aspect of the equipment. They are concerned with
the radiation exposure to the operator and the patient. The
health specialist assesses the amount of exposure the
patient is receiving. This is compared to the acceptable
range. Problems are frequently not with the equipment, but
with the film processing. The x-ray operator mistakenly
turns up the radiation exposure in trying to get a better
picture. The legislation does not direct anyone to look at
film processing.
Representative Davies noted that the Department of Health
and Social Services is proposing to test machines every
three years. He asked what is the standard practice. Ms.
Coleman noted that the rate of inspections varies. She
maintained that inspections should be every three years in
Alaska because there is not easy access to service
companies.
Representative Davies asked if radiation is absorbed in six
feet in every case. Ms. Coleman emphasized that x-ray heads
are wider and easier to move around. There is a lack of
shielding in the x-ray head. There is a potential for more
radiation.
Representative Davies questioned if comments regarding the
low level of radiation and long lasting calibration were
accurate. He asked if older equipment would meet this
description. Ms. Coleman observed that she discovered a
gassing x-ray tube. The radiation from the x-ray head was
exponentially doubled. A technician had not caught the
problem.
Ms. Reardon pointed out that the legislation would take
effect 90 days after passage. She noted that all machines
would have to be inspected and display inspection stickers
within 90 days. She suggested that January 1, 1999 as the
quickest recommended effective date.
LYNN LEVENGOOD, ATTORNEY, ANCHORAGE testified via
teleconference in support of the legislation. He maintained
that he legislation would provide better protection to
Alaskans. Regulators would be able to concentrate on higher
dose radioactive equipment. He observed that machines are
in daily use. He maintained that malfunctions would be
perceived in the quality of the x-ray. He maintained that
the risk is minimal.
SIDNEY HEIDERSDORF, RADIOLOGICAL PHYSICIST, JUNEAU testified
in opposition to SB 160. He observed that he worked in the
field of radiation safety for 38 years. He was the state
Radiological Physicist for 20 years. He emphasized that the
public is directly exposed to ionizing radiation from
dentistry equipment. He stressed that oversight should not
be transferred to a different department based on the risk
level. He observed that the legislation calls for
experience in installing and calibrating x-ray equipment. A
radiological health specialist evaluates radiation risks.
The maintenance person is a mechanic. He emphasized that
the jobs are different. He did not think the qualifications
contained in the bill would meet the qualifications needed
to do radiological health evaluations.
(Tape Change, HFC 98 - 160, Side 2)
Mr. Heidersdorf maintained that installers are blas about
radiation exposure. He disagreed that dental x-ray
radiation would be absorbed in six feet of air. He pointed
out that it is difficult to compare environmental radiation
with dental x-rays. Dental x-ray radiation is exposed to a
small area of the body. He pointed out that dental x-ray
equipment uses the same voltage as other medical x-ray
equipment. The risk is less because of the narrow band.
The thyroid is at risk when doing dental x-ray work. He
observed that in his 20 years of work no dentist every
requested an inspection. He maintained that there are other
reasons dentist want the program moved to the Department of
Commerce and Economic Development. The federal standard is
basically a manufacture standard. It applies to one year.
He viewed the legislation as a company rubber stamp of
approval with less oversight. He stressed that it is unwise
to turn the program over to administrators that will not be
able to provide oversight. He acknowledged a problem with
frequency of inspections. He used exposure range to
determine priorities in visits. He recalled that
approximately 40 percent of the dentist offices were out of
the acceptable exposure range.
Mr. Heidersdorf referred to page 2, lines 8 and 9. "The
board shall adopt the stricter of the two standards unless
adoption of the other standard would not present a risk of
harm to the public or to the operator of the equipment." He
questioned who would make the determination of risk. He
noted the use of "radionuclides" on page 3, line 9. He
stated that he did not know of "radionuclides" in dental x-
ray equipment.
Representative Kelly stressed that it is not necessary for a
person to have a degree in radiation physics. Mr.
Heidersdorf clarified that he objected to the removal of the
program from other programs dealing with x-rays. He
maintained that adequate thought has not been given to the
people that would be doing the inspections. He questioned
who would establish the standards. He asked if the Board of
Dentistry would develop standards for dental practice. He
stressed that the program is more than hardwire. He
stressed that there is the whole area of use. How is the
film developed is a huge issue. He asked if inspectors
would evaluate the darkroom processing of dental x-rays.
The only difference between a x-ray and a light ray is
energy.
Representative Davies pointed out that 2 - 4 x-rays might be
taken at a visit. Mr. Heidersdorf stressed that the damage
is a function of dose level. The exposure would not be
multiplied if the exposure were to a different area of the
face.
Representative Martin asked what Mr. Heidersdorf would do to
improve the legislation. Mr. Heidersdorf replied that the
legislation is a mistake.
Representative Kelly maintained that it is an administrative
problem not a matter of standards. He spoke in support of
the legislation.
Representative Davies felt it was more than an
administrative issue. He thought that moving the program to
the Board of Dentistry would result in a conflict of
interest or an appearance of a conflict of interest.
Ms. Krogseng maintained that the educational background of
the potential inspectors would be somewhat equivalent to
those in the Department of Health and Social Services. She
envisioned that inspectors would go to several villages at
one time to reduce costs. She spoke in support of oversight
by the Board of Dentistry. She reiterated that risks are
minimal. She emphasized that the legislation privatizes.
She acknowledged that there could be a problem with the
transitioning the program. She offered a conceptual
amendment: "Notwithstanding other provisions of this Act,
clinical radiological equipment which has been registered
under AS 08.36.075 (c) before January 1, 1999 shall be
issued an initial inspection seal valid until July 1, 1999
after payment of the fee".
Representative Martin refereed to subsection (f) on page 3:
"Notwithstanding AS 08.01.075 and AS 08.36.315, the only
penalty applicable to a licensee for violating this section
is the imposition by the board in a disciplinary action of a
civil fine not to exceed $5,000 for each violation." He
questioned why it did not include license revocation. Ms.
Krogseng observed that the dentist does not necessarily own
the equipment. She felt that a $5,000 dollar fine would be
sufficient.
Representative Martin noted that "the board may not adopt a
standard under this section that is more stringent than a
standard applicable under federal law". He questioned why
the Board should not have flexibility to issue regional
standards. Ms. Krogseng observed that the federal
government approves the manufacturer's standards. She
maintained that FDA standards are stringent.
Representative Kohring moved to adopt Amendment 1 on behalf
of Senator Taylor. Amendment 1 would add include completion
of a United States Department of Defense biomedical
equipment technician's course and the International
Certification Commission for Clinical Engineers and
Biomedical Technology as allowable qualification for
inspectors. Ms. Krogseng discussed the amendment. She
maintained that the Department of Defense schools are very
good.
Representative Davies OBJECTED. He questioned if the new
qualifications would be comparable.
Representative Mulder announced that the amendment would be
HELD.
SB 160 was HELD in Committee for further consideration.
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