N.H. Admin. Code § He-P 4032.03

Current through Register No. 36, September 5, 2024

Section He-P 4032.03 - Licensing the Manufacture and Distribution of Devices to Persons Generally Licensed

(a) An application for a specific license to manufacture or initially transfer devices containing byproduct material, excluding special nuclear material, to persons generally licensed under He-P 4031.04, or equivalent regulations of the NRC, or an agreement state as established by the Atomic Energy Act of 1954, or a licensing state shall be approved if:

(1) The applicant satisfies the general requirements of He-P 4030.09;

(2) The applicant submits complete information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device which shall ensure that:

a. The device can be safely operated by persons not having training in radiological protection;

b. Under ordinary conditions of handling, storage, and the use of the device, the byproduct material contained in the device cannot be released or inadvertently removed from the device;

c. Under ordinary conditions of handling, storage, and the use of the device, it is unlikely that any person will receive in one year a dose in excess of 10% of the annual limits specified in He-P 4020.05; and

d. Under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the organ doses in Table 4032.1 below:

Table 4032.1 Organ Doses Under Accident Conditions

Body Part	Organ Dose
Whole body; head and trunk; active blood-forming organs; gonads, or lens of eye	15 rems (150 mSv)
Hands and forearms; feet and localized areas of skin averaged over areas no longer than 1 square centimeter	200 rems (2 Sv)
Other organs	50 rems (500 mSv);

(3) Each device bears a durable, legible, clearly visible label or labels, which contain in a clearly identified and separate statement:

a. Instructions and precautions necessary to ensure safe installation, operation, and servicing of the device or identification of operating and service manuals used to provide this information;

b. The requirement, or exemption of a requirement, for leak testing, or for testing any on-off mechanism and indicator, to include the maximum time interval for such testing, the identification of radioactive material by isotope, the quantity of radioactivity, and the date of determination of the quantity; and

c. The information called for in the following statement in the same form:

1. "The receipt, possession, use and transfer of this device Model_____ Serial No._____ are subject to a general license or the equivalent and the regulations of the NRC, the Agreement State or the Licensing State which has regulatory authority.";

2. "This label shall be maintained on the device in a legible condition.";

3. "Removal of this label is prohibited.";

4. The words, "CAUTION - RADIOACTIVE MATERIAL"; and

5. The name of the manufacturer or distributor;

(4) Each device having a separable source housing that provides the primary shielding for the source also bears on the source housing, a durable label containing:

a. The device model number and serial number;

b. The isotope and quantity;

c. The words, "CAUTION - RADIOACTIVE MATERIAL";

d. The radiation symbol described in He-P 4022.11; and

e. The name of the manufacturer or initial distributor;

(5) Each device meeting the criteria of He-P 4031.04(e) (15) , bears a permanent, such as embossed, etched, stamped, or engraved, label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, "CAUTION-RADIOACTIVE MATERIAL", and, if practicable, the radiation symbol described in He-P 4022.11; and

(6) The device has been registered in the NRC Sealed Source and Device Registry.

(b) Should an applicant under He-P 4032.03(a) (3) b. desire that a device be required to be leak tested or tested for proper operation of the on-off mechanism and indicator, at intervals greater than 6 months, DHHS/RHS shall consider at least the following information in determining the acceptable interval:

(1) Primary containment (source capsule);

(2) Protection of primary containment;

(3) Method of sealing containment;

(4) Containment construction materials;

(5) Form of contained radioactive material;

(6) Maximum temperature withstood during prototype test;

(7) Maximum pressure withstood during prototype tests;

(8) Maximum quantity of contained radioactive material;

(9) Radiotoxicity of contained radioactive material; and

(10) Operating experience with identical devices or similarly designed and constructed devices.

(c) In the event the applicant under He-P 4032.03(a) desires that the general licensee under He-P 4031, or under equivalent regulations of the NRC, an agreement state, or a licensing state, be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of byproduct material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall:

(1) Include written instructions to be followed by the general licensee;

(2) Include the estimated calendar-quarter doses associated with such activity or activities, and bases for such estimates; and

(3) Demonstrate that performance of such activity or activities by an individual untrained in radiological protection is unlikely to cause that individual to receive a calendar-quarter dose in excess of 10% of the limits specified in He-P 4020.06(a) .

(d) If a device containing byproduct material is to be transferred for use under the general license contained in He-P 4031.04(b) , each person that is licensed under He-P 4032.03 shall provide to each person to whom a device is to be transferred, prior to transferring the device, the following:

(1) A copy of the general license contained in He-P 4031.04(b) , except if paragraphs He-P 4031.04(e) (2) through (e) (4) or He-P 4031.04(e) (15) do not apply to the particular device, those paragraphs may be omitted;

(2) A copy of He-P 4031.02, He-P 4030.10(n) , He-P 4021.12, He-P 4021.13, and He-P 4021.19;

(3) A list of the services that can only be performed by a specific licensee;

(4) Information on acceptable disposal options including estimated costs of disposal; and

(5) An indication that DHHS/RHS shall take enforcement action for improper disposal.

(e) If the transfer specified in He-P 4032.03(d) is through an intermediate person, the information to be provided as described in He-P 4032.03(d) shall also be provided to the intended user prior to initial transfer to the intermediate person.

(f) If byproduct material is to be transferred in a device for use under the equivalent general license of an agreement state or equivalent regulations of the NRC, or a licensing state each person that is licensed under He-P 4032.03 shall provide to each person to whom a device is to be transferred, prior to transferring the device, the following:

(1) A copy of the agreement state's regulations equivalent to He-P 4031.04, He-P 4031.02, He-P 4030.10(n) , He-P 4021.12, and He-P 4021.13, a copy of 10 CFR §§31.5, 31.2, 30.51, 20.2201, and 20.2202, or

(2) A copy of He-P 4031.04, He-P 4030.02, He-P 4030.10(n) , He-P 4021.12, and He-P 4021.13, except if certain paragraphs of these rules do not apply to the particular device, those paragraphs may be disregarded;

a. If a copy of the agreement state's regulations equivalent to New Hampshire rules as listed in this paragraph, is provided to a prospective general licensee in lieu of the applicable agreement state's, licensing state's or NRC regulations, the copy of the agreement state's, licensing state's or equivalent regulations of the NRC shall be accompanied by a note explaining that use of the device is regulated by the agreement state, licensing state or NRC, as applicable; and

b. If certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted;

(3) A list of the services that can only be performed by a specific licensee;

(4) Information on acceptable disposal options including estimated costs of disposal; and

(5) The name or title, address, and phone number of the contact at the agreement state or licensing state regulatory agency or NRC from which additional information may be obtained.

(g) If the transfer specified in He-P 4032.03(f) is through an intermediate person, the information to be provided as described in He-P 4032.03(f) shall also be provided to the intended user prior to initial transfer to the intermediate person.

(h) In lieu of the requirements of He-P 4032.03(d) through (g) above, the applicant may propose an alternative approach to informing customers, subject to approval by DHHS/RHS. In its review of such a request, DHHS/RHS shall ensure that the proposed alternative approach to informing customers:

(1) Meets the essential objectives of He-P 4032.03(d) through (g) ;

(2) Provides the same information as required by He-P 4032.03(d) through (g) ; and

(3) Is not harmful to public health and safety.

(i) Each device that is transferred after November 17, 2005, shall meet the labeling requirements in He-P 4032.03(a) (3) through (a) (5) .

(j) If a notification of bankruptcy has been made under He-P 4030.10(h) or the license is to be terminated, each person licensed under He-P 4032.03 shall provide, upon request, to DHHS/RHS, the NRC, any appropriate agreement state, or licensing state records of final disposition required under He-P 4032.03(m) and (n) .

(k) Each person licensed under He-P 4032.03 to initially transfer devices to generally licensed persons shall:

(1) Report, in a clear and legible report, to DHHS/RHS all transfers of such devices to persons for use under the general license in He-P 4031.03 and all receipts of devices from persons licensed under He-P 4031.03 including:

a. The identity of each general licensee by name and mailing address, and address location of use. If there is no mailing address for the location of use, an alternative address for the general licensee shall be submitted along with information on the actual location of use;

b. The name, title, and telephone number of the individual identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the applicable rules, and who may constitute a point of contact between DHHS/RHS and the general licensee;

c. The date of transfer;

d. The type, model number, and serial number of device transferred;

e. The quantity and type of byproduct material contained in the device;

f. If one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the general licensee shall provide the same information for both the intended user and each intermediate person, which shall clearly designate and identify the intermediate person(s); and

g. The identity of the specific licensee submitting the report, including the license number of the specific licensee;

(2) Report, in a clear and legible report, to DHHS/RHS all receipts of devices from persons licensed under He-P 4031.03, including, for devices received from persons generally licensed under He-P 4031.03:

a. The identity of the general licensee by name and address;

b. The type, model number, and serial number of the device received;

c. The date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor; and

(3) Report to DHHS/RHS the identity of the general licensee, the device, and the changes to information on the device label, if the licensee authorized under He-P 4032.03 makes changes to a device possessed by a general licensee authorized under He-P 4031.04(b) , such that the label must be changed to update required information;

(4) Report to DHHS/RHS if no transfers have been made to or from persons generally licensed under He-P 4031.04(b) during the reporting period;

(5) Report to the NRC, on NRC Form 653 "Transfers of Industrial Devices Report" or in a clear and legible report containing all data required by the form, all transfers of such devices to persons for use under the NRC general license in section 31.5 of 10 CFR 31;

(6) Report to the responsible agreement state, licensing state agency or the NRC all transfers of such devices to persons for use under a general license in the agreement state's licensing state's or NRC regulations equivalent to He-P 4031;

(7) Identify in the report required by He-P 4032.03(k) (5) or (6) , the following:

a. The identity of each general licensee by name and mailing address, and address location of use; if there is no mailing address for the location of use, an alternative address for the general licensee shall be submitted along with information on the actual location of use;

c. The date of transfer;

d. The type, model, and serial number of the device transferred;

e. The quantity and type of byproduct material contained in the device; and

f. The identity of the specific licensee submitting the report, including the license number of the specific licensee;

(8) Report to the NRC, on NRC Form 653 "Transfers of Industrial Devices Report" or in a clear and legible report containing all data required by the form, all receipts of such devices from persons authorized under the NRC general license in section 31.5 of 10 CFR 31;

(9) Report to the responsible agreement state, or licensing state agency or the NRC all receipts of such devices from persons authorized under a general license in the agreement state's, licensing state's or NRC regulations equivalent to He-P 4031.04;

(10) Include in the report for devices received from persons generally licensed under agreement state, licensing state, or NRC regulations equivalent to He-P 4031.04:

a. The identity of the general licensee by name and address;

b. The type, model number, and serial number of the device received;

c. The date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor; and

d. The identity of the specific licensee submitting the report, including the license number of the specific licensee;

(11) Report to the responsible agreement state or licensing state agency or the NRC, the identity of the general licensee, the device, and the changes to information on the device label, if the licensee authorized under He-P 4032.03 makes changes to a device possessed by a general licensee authorized under regulations equivalent to He-P 4031.04(b) , such that the label must be changed to update required information;

(12) Report to the NRC, if no transfers have been made to or from NRC general licensees during the reporting period;

(13) Report to the agreement state or licensing state agency or the NRC regulated state if no transfers have been made to or from that agreement state or licensing state or the NRC regulated state during the reporting period;

(14) Keep records showing:

a. The name of each general licensee or intermediate person to whom transfers of byproduct material in devices for use pursuant to the general license provided in He-P 4031.04, or equivalent regulations of the NRC, an agreement state or licensing state have been made;

b. Address of each general licensee or intermediate person to whom transfers of byproduct material in devices for use pursuant to the general license provided in He-P 4031.04, or equivalent regulations of the NRC, an agreement state or licensing state have been made;

c. The point of contact for each general licensee or intermediate person to whom transfers of byproduct material in devices for use pursuant to the general license provided in He-P 4031.04, or equivalent regulations of the NRC, an agreement state or licensing state have been made;

d. The date of each transfer of byproduct material;

e. Identification of the radioisotope contained in each device transferred;

f. The quantity of radioactivity in each device transferred;

g. The identity of any intermediate person; and

h. The requirements of He-P 4031 specifics for this transfer;

(15) Cover each calendar quarter in its reports submitted under He-P 4032;

(16) Submit reports required in He-P 4032.03 within 30 days of the end of the calendar quarter; and

(17) Indicate in reports required in He-P 4032.03, the period covered by the report.

(l) In the event that one or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the licensee shall provide the same information for both the intended user and each intermediate person, and shall clearly designate the identity of the intermediate person(s); and

(m) Each person licensed under He-P 4032.03 shall maintain all information concerning transfers and receipts of devices that supports the reports required by this section.

(n) Records required by (l) shall be maintained for a period of 3 years following the date of the recorded event.

N.H. Admin. Code § He-P 4032.03

(See Revision Note at part heading for He-P 4032) #6942, eff 2-1-99; ss by #8488, eff 11-18-05; ss by #8959, eff 8-7-07

Amended by Volume XXXV Number 49, Filed December 10, 2015, Proposed by #10983, Effective 11/24/2015, Expires11/24/2025.