SB45: Bill Text

SB45,1131,12 2. A physician who diagnoses the birth defect or provides treatment to the infant or child for the birth defect.

SB45,1131,14 3. A clinical laboratory that identifies a birth defect in the infant or child as the result of laboratory analysis.

SB45,1131,18 (b) No person specified under par. (a) 1. to 3. need report under par. (a) if that person knows that another person specified under par. (a) 1. to 3. has already reported to the department the required information with respect to the same birth defect of the same infant or child.

SB45,1131,23 (c) Upon request of the department, a physician, hospital or pediatric specialty clinic shall provide to the department information contained in the medical records of patients who have a confirmed or suspected birth defect diagnosis. The physician, hospital or pediatric specialty clinic shall provide that information within 10 working days after the department requests it.

SB45,1131,25 (3) Department duties and powers. (a) The department shall do all of the following:

SB45,1132,4 1. Establish and maintain an up-to-date registry that documents the diagnosis in this state of any infant or child who has a birth defect, regardless of the residence of the infant or child. The department shall include in the registry information that will facilitate all of the following:

SB45,1132,5 a. Identification of risk factors for birth defects.

SB45,1132,7 b. Investigation of the incidence, prevalence and trends of birth defects using epidemiological surveys.

SB45,1132,9 c. Development of preventive strategies to decrease the occurrence of birth defects.

SB45,1132,11 2. Specify by rule the birth defects the existence of which requires a report under sub. (2) to be submitted to the department.

SB45,1132,13 3. Specify by rule the content, format and procedures for submitting a report under sub. (2).

SB45,1132,16 (b) The department may monitor the data contained in the reports submitted under sub. (2) to ensure the quality of that data and to make improvements in reporting methods.

SB45,1132,22 (4) Council on birth defect prevention and surveillance. The council on birth defect prevention and surveillance, created under s. 15.197 (12), shall make recommendations to the department regarding the establishment of a registry that documents the diagnosis and treatment in the state of an infant or child who has a birth defect, as required under sub. (3) (a) 1. and regarding the rules that the department is required to promulgate under sub. (3) (a) 2. and 3.

SB45,1133,2 (5) Confidentiality. (a) Any information contained in a report made to the department under sub. (2) that may specifically identify the subject of the report is confidential. The department may not release that confidential information except to the following, under the following conditions:

SB45,1133,4 1. The parent or guardian of an infant or child for whom a report is made under sub. (2).

SB45,1133,11 2. A local health officer, upon receipt of a written request and informed written consent from the parent or guardian of the infant or child. The local health officer may disclose information received under this subdivision only to the extent necessary to render and coordinate follow-up care for the infant or child or to conduct a health, demographic or epidemiological investigation. The local health officer shall destroy all information received under this subdivision within one year after receiving it.

SB45,1133,14 3. A physician, hospital or pediatric specialty clinic reporting under sub. (2), for the purpose of verification of information reported by the physician, hospital or pediatric specialty clinic.

SB45,1133,24 4. A representative of a federal or state agency upon written request and to the extent that the information is necessary to perform a legally authorized function of that agency, including investigation of causes, mortality, methods of prevention, treatment or care of birth defects, associated diseases or disabilities. The information may not include the name or address of an infant or child with a condition reported under sub. (2). The department shall notify the parent or guardian of an infant or child about whom information is released under this subdivision, of the release. The representative of the federal or state agency may disclose information received under this paragraph only as necessary to perform the legally authorized function of that agency for which the information was requested.

SB45,1134,2 (b) The department may also release confidential information to a person proposing to conduct research if all of the following conditions are met:

SB45,1134,7 1. The person proposing to conduct the research applies in writing to the department for approval to perform the research and the department approves the application. The application for approval shall include a written protocol for the proposed research, the person's professional qualifications to perform the proposed research and any other information requested by the department.

SB45,1134,9 2. The research is for the purpose of studying birth defects surveillance and prevention.

SB45,1134,20 3. If the research will involve direct contact with a subject of a report made under sub. (2) or with any member of the subject's family, the department determines that the contact is necessary for meeting the research objectives and that the research is in response to a public health need or is for the purpose of or in connection with birth defects surveillance or investigations sponsored and conducted by public health officials. The department must also determine that the research has been approved by a certified institutional review board or a committee for the protection of human subjects in accordance with the regulations for research involving human subjects required by the federal department of health and human services for projects supported by that agency. Contact may only be made in a manner and method approved by the department.

SB45,1134,22 4. The person agrees in writing that the information provided will be used only for the research approved by the department.

SB45,1134,24 5. The person agrees in writing that the information provided will not be released to any person except other persons involved in the research.

SB45,1135,3 6. The person agrees in writing that the final product of the research will not reveal information that may specifically identify the subject of a report made under sub. (2).

SB45,1135,5 7. The person agrees in writing to any other conditions imposed by the department.

SB45, s. 2441 Section 2441. 254.31 (1) (b) of the statutes is created to read:

SB45,1135,9 254.31 (1) (b) The tailings or waste produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content.

SB45, s. 2442 Section 2442. 254.31 (2) of the statutes is created to read:

SB45,1135,14 254.31 (2) "Decommissioning" means conducting final operational activities at a nuclear facility to dismantle site structures, to decontaminate site surfaces and remaining structures, to stabilize and contain residual radioactive material and to carry out any other activities necessary to prepare the site for postoperational care.

SB45, s. 2443 Section 2443. 254.31 (2m) of the statutes is created to read:

SB45,1135,19 254.31 (2m) "General license" means a license, under requirements prescribed by the department by rule, to possess, use, transfer or acquire by-product material or devices or equipment utilizing by-product material without the filing of a license application by a person or issuance of licensing confirmation by the department.

SB45, s. 2444 Section 2444. 254.31 (3) of the statutes is renumbered 254.31 (1) (intro.) and amended to read:

SB45,1135,23 254.31 (1) (intro.) "By-product material" means any radioactive of the following:

SB45,1136,3 (a) Radioactive material ( ,except special nuclear material), yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material.

SB45, s. 2445 Section 2445. 254.31 (3g) of the statutes is repealed and recreated to read:

SB45,1136,6 254.31 (3g) "Ionizing radiation" means all radiations capable of producing ions directly or indirectly in their passage through matter, including all of the following:

SB45,1136,7 (a) Electromagnetic radiations, including X-rays and gamma rays.

SB45,1136,9 (b) Particulate radiations, including electrons, beta particles, protons, neutrons, alpha particles and other nuclear particles.

SB45, s. 2446 Section 2446. 254.31 (5) of the statutes is created to read:

SB45,1136,15 254.31 (5) "Radiation generating equipment" means a system, manufactured product or device or component part of such a product or device that, during operation, is capable of generating or emitting ionizing radiation without the use of radioactive material. "Radiation generating equipment" does not include a device that emits nonionizing radiation.

SB45, s. 2447 Section 2447. 254.31 (6) of the statutes is amended to read:

SB45,1136,19 254.31 (6) "Radiation installation" is any location or facility where radiation machines are generating equipment is used or where radioactive material is produced, transported, stored, disposed of or used for any purpose.

SB45, s. 2448 Section 2448. 254.31 (7) of the statutes is repealed.

SB45, s. 2449 Section 2449. 254.31 (8) of the statutes is renumbered 254.31 (9m) and amended to read:

SB45,1137,2 254.31 (9m) "Radioactive material" includes any solid, liquid or gaseous substance which emits ionizing radiation spontaneously, including accelerator-produced material, by-product material, naturally occurring material, source material and special nuclear material.

SB45, s. 2450 Section 2450. 254.31 (9) of the statutes is amended to read:

SB45,1137,5 254.31 (9) "Radiation source" means a radiation machine generating equipment or radioactive material as defined herein.

SB45, s. 2451 Section 2451. 254.31 (11g) of the statutes is created to read:

SB45,1137,9 254.31 (11g) "Specific license" means a license, under requirements prescribed by the department by rule, to possess, use, manufacture, produce, transfer or acquire radioactive material or devices or equipment utilizing radioactive material.

SB45, s. 2452 Section 2452. 254.31 (11m) of the statutes is created to read:

SB45,1137,12 254.31 (11m) "Transuranic" means a radioactive material having an atomic number that is greater than 92.

SB45, s. 2453 Section 2453. 254.31 (12) of the statutes is amended to read:

SB45,1137,16 254.31 (12) "X-ray tube" means any electron tube which that is contained in a device and that is specifically designed for the conversion of electrical energy into X-ray energy.

SB45, s. 2454 Section 2454. 254.33 of the statutes is amended to read:

SB45,1138,4 254.33 Public policy. Since radiations and their sources can be instrumental in the improvement of the health and welfare of the public if properly utilized, and may be destructive or detrimental to life or health if carelessly or excessively employed or may detrimentally affect the environment of the state if improperly utilized, it is hereby declared to be the public policy of this state to encourage the constructive uses of radiation and to prohibit and prevent exposure to radiation in amounts which are or may be detrimental to health. It is further the policy for the department to advise, consult and cooperate with the department of commerce and other agencies of the state, the federal government, other states and interstate agencies and with affected groups, political subdivisions and industries; and, in general, to conform as nearly as possible to nationally accepted standards in the promulgation and enforcement of rules.

SB45, s. 2455 Section 2455. 254.335 of the statutes is created to read:

SB45,1138,11 254.335 Agreements with the U.S. nuclear regulatory commission transition. (1) The governor may, on behalf of the state, enter into agreements with the U.S. nuclear regulatory commission, as provided in 42 USC 2021 (b), to discontinue certain federal licensing and related regulatory authority with respect to by-product material, source material and special nuclear material and to assume state regulatory authority.

SB45,1138,19 (2) Any person who, on the effective date of an agreement specified under sub. (1), possesses a license issued by the U.S. nuclear regulatory commission that is subject to the agreement is considered to possess a specific license issued under s. 254.365 (1) (a) or to fulfill requirements specified for a general license under s. 254.365 (1) (b). The specific license expires 90 days after the date of receipt by the person from the department of a notice of expiration of the license or on the date of expiration that was specified in the license issued by the U.S. nuclear regulatory commission, whichever is earlier.

SB45, s. 2456 Section 2456. 254.34 (1) (intro.) of the statutes is amended to read:

SB45,1138,22 254.34 (1) (intro.) The department and the department of commerce is the state radiation control agency and shall do all of the following:

SB45, s. 2457 Section 2457. 254.34 (1) (a) of the statutes is amended to read:

SB45,1139,7 254.34 (1) (a) Formulate, adopt and enforce, amend and repeal Promulgate and enforce rules, including registration and licensing of sources of ionizing radiation, as may be necessary to prohibit and prevent unnecessary radiation . Such exposure. The rules may incorporate by reference the recommended standards of nationally recognized bodies in the field of radiation protection and other fields of atomic energy, under the procedure established by s. 227.21 (2). The rules for by-product material, source material and special nuclear material may be no less stringent than the requirements under 42 USC 2011 to 2114 and regulations adopted under 42 USC 2011 to 2114.

SB45, s. 2458 Section 2458. 254.34 (1) (c) of the statutes is renumbered 254.34 (1) (c) (intro.) and amended to read:

SB45,1139,15 254.34 (1) (c) (intro.) Develop comprehensive policies and programs for the evaluation and, determination and reduction of hazards associated with the use of radiation, and for their amelioration. that are compatible with requirements of the U.S. nuclear regulatory commission for the regulation of by-product material, source material and special nuclear material. The department shall maintain all of the following records:

SB45, s. 2459 Section 2459. 254.34 (1) (c) 1. of the statutes is created to read:

SB45,1139,18 254.34 (1) (c) 1. Files of all license applications, issuances, denials, transfers, renewals, modifications, suspensions and revocations under s. 254.365.

SB45, s. 2460 Section 2460. 254.34 (1) (c) 2. of the statutes is created to read:

SB45,1139,21 254.34 (1) (c) 2. Files of all registrants under s. 254.35 and any related administrative or judicial action.

SB45, s. 2461 Section 2461. 254.34 (2) (intro.) of the statutes is amended to read:

SB45,1139,24 254.34 (2) (intro.) The department, serving as the lead agency, and the department of commerce may:

SB45, s. 2462 Section 2462. 254.34 (4) of the statutes is renumbered 254.34 (1) (h) 5.

SB45, s. 2463 Section 2463. 254.345 of the statutes is created to read:

SB45,1140,7 254.345 Assessment of Fee. (1) The department may annually assess a fee of 36% of the U.S. nuclear regulatory commission license application fee and materials license annual fee, for any licensee of the U.S. nuclear regulatory commission in this state. The fee amounts shall be used by the department for the department's activities under this subchapter. The department may revise the fee amounts by rule.

SB45,1140,8 (2) This section does not apply after December 31, 2002.

SB45, s. 2464 Section 2464. 254.35 (1) of the statutes is amended to read:

SB45,1141,6 254.35 (1) Application. Every For every site in this state having that has an ionizing radiation installation, that is not exempted by this section or the rules of the department shall be registered by the department by January 1, 1964, by, the person in control of an the installation, including installations in sites that are administered by a state agency or in an institution under the jurisdiction of a state agency, and no such shall, prior to operation, register the ionizing radiation installation with the department. No ionizing radiation installation may be operated thereafter unless the site has been duly registered by January 1 of each year and a notice of the registration is possessed by the person in control. Every site having an ionizing radiation installation established in this state after July 20, 1985, shall be registered prior to its operation. The application for registration shall be made on forms provided by the department which shall be devised to obtain any information that is considered necessary for evaluation of hazards. Multiple radiation sources at a single radiation installation and under the control of one person shall be listed on a single registration form. Registration fees shall be levied in accordance with sub. (3). Registration alone shall does not imply approval of manufacture, storage, use, handling, operation or disposal of the radiation installation or radioactive materials, but shall serve serves merely to inform the department of the location and character of radiation sources. The department shall furnish the department of commerce with a copy of each amended and new registration. Persons engaged in manufacturing, demonstration, sale, testing or repair of radiation sources shall not be are not required to list such sources on the registration form.

SB45, s. 2465 Section 2465. 254.35 (2) of the statutes is amended to read:

SB45,1141,19 254.35 (2) Amended registration. If the person in control increases the number of sources, source strength, rated output or energy of radiation produced in any installation, he or she shall notify the department of the increase prior to operation on the revised basis. The department shall record the change in the registration. No registration is transferable from one premises to another or from one person to another. If the person in control transfers intends to transfer control of ownership of the radiation installation to another person the registration also transfers to the other person, who, at least 15 days before the final transfer the registrant shall notify the department of the transfer within 15 days. The department shall record the change in the and the intended transferee shall file under sub. (1) an application for registration. If any installation is discontinued, the person in control shall notify the department within 30 days of the discontinuance.

SB45, s. 2466 Section 2466. 254.35 (3) (title) of the statutes is amended to read:

SB45,1141,21 254.35 (3) (title) Fees Registration fees.

SB45, s. 2467 Section 2467. 254.35 (3) (a) of the statutes is amended to read:

SB45,1142,3 254.35 (3) (a) An annual registration fee under pars. (b) to (f) (fm) shall be levied for each site registration under this section. An additional penalty fee of $10 $25, regardless of the number of X-ray tubes or generally licensed devices, shall be required for each registration whenever the annual fee for renewal is not paid prior to expiration of the registration. No additional fee may be required for recording changes in the registration information.

SB45, s. 2468 Section 2468. 254.35 (3) (b) of the statutes is amended to read:

SB45,1142,8 254.35 (3) (b) For a medical site having an ionizing radiation installation serving physicians and clinics, osteopaths and clinics, and chiropractors or hospitals that possesses radioactive materials in any quantity, the fee shall be at least $25 $36 for each site and at least $30 $44 for each X-ray tube.

SB45, s. 2469 Section 2469. 254.35 (3) (c) of the statutes is amended to read:

SB45,1142,12 254.35 (3) (c) For a chiropractic, podiatric or veterinary site having an ionizing radiation installation, the fee shall be at least $25 $36 for each site and at least $30 $44 for each X-ray tube.

SB45, s. 2470 Section 2470. 254.35 (3) (d) of the statutes is amended to read:

SB45,1142,15 254.35 (3) (d) For a dental site having an ionizing radiation installation, the fee shall be at least $25 $36 for each site and at least $20 $30 for each X-ray tube.