He-P 4030.10 - Specific Licenses, Issuance

He-P 4030.10. Specific Licenses, Issuance

(a) Upon a determination that an application meets the requirements of the applicable sections of He-P 4000, He-P 4030, and RSA 125-F, DHHS/RHS shall issue a specific license authorizing the proposed activity.

(b) DHHS/RHS shall incorporate into any license issued pursuant to this part and He-P 4031 through 4036, and He-P 4039, at the time of issuance or thereafter, by appropriate rule or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of byproduct material as it deems appropriate or necessary in order to:

(1) Protect the public health and minimize danger to life or property;

(2) Require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and

(3) Prevent loss or theft of material subject to this part.

(c) Specific licenses shall be issued to named persons upon applications filed pursuant to He-P 4030.

(d) Each license issued pursuant to this part and parts He-P 4031 through 4036, and He-P 4039, shall be subject to all the provisions of RSA 125-F, to all rules of DHHS/RHS He-P 4000, and orders of the commissioner of the department of health and human services.

(e) Neither the license nor any right under the license issued or granted pursuant this part and parts He-P 4031 through 4036, and He-P 4039, shall be assigned or otherwise transferred in violation of the provision of RSA 125-F.

(f) Each person licensed by DHHS/RHS pursuant to this part shall confine his use and possession of the material licensed to conditions specified on the license, such as:

(1) Standard licensing conditions as set forth in these rules, or

(2) Conditions formulated specifically for an individual license.

(g) Each licensee shall notify DHHS/RHS in writing when the licensee decides to permanently discontinue all activities involving materials authorized under the license.

(h) Each general licensee that is required to register by He-P 4031, and each specific licensee, shall notify DHHS/RHS in writing immediately following the filing of a voluntary or involuntary petition for bankruptcy under any Chapter of Title 11 of the United States Code by or against:

(1) The licensee;

(2) An entity, as that term is defined in 11 U.S.C. 101(15), controlling the licensee or listing the license or licensee as property of the estate; or

(3) An affiliate, as that term is defined in 11 U.S.C. 101(2), of the licensee.

(i) The notification specified in He-P 4030.10(h) shall indicate the bankruptcy court in which the petition for bankruptcy was filed and the date of the filing of the petition.

(j) Each licensee shall notify DHHS/RHS of radiological incidents and events, as follows:

(1) As soon as possible but not later than 4 hours after the discovery of an event that prevents immediate protective actions necessary to avoid exposures to radiation or radioactive materials that could exceed the limits specified in He-P 4020, or releases of licensed material that could exceed the limits specified in He-P 4020; and

(2) Within 24 hours after the discovery of any of the following events involving licensed material:

a. An unplanned contamination event that:

1. Requires access to the contaminated area, by workers or the public, to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area;

2. Involves a quantity of radioactive material greater than 5 times the lowest annual limit of intake specified in He-P 4090 for the material; and

3. Requires access to the area to be restricted for a reason other than to allow isotopes with a half-life of less than 24 hours to decay prior to decontamination;

b. An event in which equipment is disabled or fails to function as designed when:

1. The equipment is required by the rules or license condition to prevent releases exceeding regulatory limits, to prevent exposures to radiation and radioactive materials exceeding the limits specified by He-P 4020, or to mitigate the consequences of an accident;

2. The equipment is required to be available and operable when it is disabled or fails to function; and

3. No redundant equipment is available and operable to perform the required safety function;

c. An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body; and

d. An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed material when:

1. The quantity of radioactive material involved is greater than 5 times the lowest annual limit on intake specified in He-P 4090 for the material; and

2. The damage affects the integrity of the licensed material or its container.

(k) Licensees shall make reports to DHHS/RHS required by He-P 4030.10(j)(1) and (2) above, by telephone via the New Hampshire state police communications center at (603) 271-3636.

(l) To the extent that the information is available at the time of notification, the information provided in the telephonic report pursuant to (k) above shall include:

(1) The caller's name and call back telephone number;

(2) A description of the event, including date and time;

(3) The exact location of the event;

(4) The isotopes, quantities, and chemical and physical form of the licensed material involved; and

(5) Any personnel radiation exposure data available.

(m) Each licensee who makes a report required by He-P 4030.10(j)(1) and (2) shall submit to DHHS/RHS a written follow-up report within 30 days of the initial report, which includes the following information:

(1) A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned;

(2) The exact location of the event;

(3) The isotopes, quantities, and chemical and physical form of the licensed material involved;

(4) Date and time of the event;

(5) Corrective actions taken or planned and the results of any evaluations or assessments; and

(6) The extent of exposure of individuals to radiation or to radioactive materials without identification of individuals by name.

(n) Relative to records, each person who receives radioactive material pursuant to a license issued pursuant He-P 4030 through He-P 4039 shall:

(1) Keep records showing the receipt, transfer, and disposal of the radioactive material, as follows:

a. The licensee shall retain each record of receipt of radioactive material as long as the material is possessed and for 3 years following transfer or disposal of the material;

b. The licensee who transferred the radioactive material shall retain each record of transfer for 3 years after each transfer unless otherwise specified in this chapter; and

c. The licensee who disposed of the material shall retain each record of disposal of radioactive material until the license that authorizes disposal of the material is terminated;

(2) Retain each record that is required by this chapter or by license condition for the period specified by the applicable rule or license condition, except that if a retention period is not otherwise specified by rule or license condition, the record shall be retained until the license authorizing the activity that is subject to the recordkeeping requirement is terminated;

(3) Retain records required to be maintained pursuant to this chapter in the following format:

a. The original;

b. A reproduced copy, if such reproduced copy is duly authenticated by authorized personnel;

c. Microform, if such microform is duly authenticated by authorized personnel and is capable of producing a clear and legible copy after storage for the period specified by the rules; or

d. Stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period;

(4) Ensure that all pertinent information, including stamps, initials, and signatures, are included on all required records, including letters, drawings, specifications;

(5) Maintain adequate safeguards against tampering with and loss of records;

(6) Prior to termination of a license authorizing possession of radioactive material with a half-life greater than 120 days, in an unsealed form, forward the following records to DHHS/RHS:

a. Records of disposal of licensed material made under He-P 4023; and

b. Records required by He-P 4021.03(c)(4);

(7) At the time of transfer of a radioactive material license authorizing possession of radioactive material with a half-life of greater than 120 days, in an unsealed form, transferred or assigned in accordance with He-P 4030.15 to a new licensee, transfer the following records to the new licensee and the new licensee will be responsible for maintaining these records until the license is terminated, the following:

a. Records of disposal of licensed material made under He-P 4023; and

b. Records required by He-P 4021.03(c)(4); and

(8) Prior to license termination, forward the records to DHHS/RHS as required by He-P 4030.09(o) - (r).

(o) Relative to licensees preparing technetium 99m radiopharmaceuticals from molybdenum 99/technetium 99m generators or rubidium 82 from strontium 82/rubidium 82 generators, each licensee shall test the generator eluates for molybdenum 99 breakthrough or strontium 82 and strontium 85 contamination, respectively, in accordance with He-P 4035.32. The licensee shall record the results of each test and retain each record for 3 years after the record is made.

(p) Relative to licensees authorized under He-P 4030.07(k) to produce:

(1) PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium does not relieve the licensee from complying with applicable DHHS/RHS, or agreement state, or federal requirements governing radioactive drugs; and

(2) PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium, the licensees shall satisfy:

a. The labeling requirements in He-P 4032.05(a)(4) for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of the licensees consortium; and

b. The requirement for using instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of the licensees' consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements of He-P 4032.05(d).

(q) Relative to pharmacies authorized under He-P 4030.07(k) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium, each pharmacy shall require that any individual who prepares PET radioactive drugs shall be:

(1) An authorized nuclear pharmacist that meets the requirements in He-P 4032.05(b)(2);

(2) An individual under the supervision of an authorized nuclear pharmacist as specified in He-P 4035.11. or

(3) An individual working as an authorized nuclear pharmacist who meets the requirements of He-P 4032.05(b)(2).

(r) Relative to portable gauge licensees, each licensee shall:

(1) Secure the portable gauges such that each portable gauge license shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(2) Maintain utilization logs for 3 years for each source of radiation which contains the following information:

a. A description, including the make, model and serial number of each sealed source and each device in which the sealed source is located;

b. The location and dates of use, including the dates removed and returned to storage; and

c. The identity and signature of the user of the device.

(s) Relative to licensee's survey instruments, each licensee shall:

(1) Keep sufficient calibrated and operable radiation survey instruments at each location where sources of radiation are present to make the radiation surveys required by He-P 4022;

(2) Have each radiation survey instrument calibrated:

a. At energies appropriate for use and at intervals not to exceed 12 months or after instrument servicing, except for battery changes;

b. For linear scale instruments, at 2 points located approximately one-third and two-thirds of full scale on each scale; for logarithmic scale instruments, at mid-range of each decade, and at 2 points of at least one decade; and for digital instruments, at 3 points between 0.02 and 10 millisieverts (2 and 1,000 mrem) per hour; and

c. So that an accuracy within plus or minus 20 percent at the calibration source can be demonstrated at each point checked; and

(3) Maintain records of the annual calibrations of its radiation survey instruments and retain each record for 3 years after it is made.

(Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10896, Effective 7/22/2015, Expires 1/18/2016. Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11006, Effective 1/15/2016, Expires 1/15/2026.)

(See Revision Note at part heading for He-P 4030) #6942, eff 2-1-99; ss by #8488, eff 11-18-05; ss by #8959, eff 8-7-07

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