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.