Article 175 - Radiation Control
Proposed Rules: Closed to Comments
Statement of Basis and Purpose
New York State is an Agreement State, meaning that New York State and the United States Nuclear Regulatory Commission (NRC) have entered into an agreement under the Atomic Energy Act through which the NRC has delegated authority to the State to regulate radioactive material at non-reactor sites within its jurisdiction.1 The New York State Agreement is comprised of the regulatory programs of three agencies:
1. the New York State Department of Health,
2. the New York State Department of Environmental Conservation, and
3. the New York City Department of Health and Mental Hygiene.
Under the Agreement and section 16.1 of the State Sanitary Code, the New York City Department of Health and Mental Hygiene, through the Office of Radiological Health (ORH), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City.
ORH regulations for radioactive material are contained in Article 175 of the Health Code. ORH licenses and inspects radioactive materials facilities for compliance with Article 175 for the protection of the health and safety of patients, radiation program employees and the general public. There are about 375 licensed sites in New York City possessing radioactive material for medical, academic and research purposes. ORH inspects these facilities once every 1, 2 or 3 years depending on the type of use.
Each Agreement State program is required to maintain compatibility with the NRC regulatory program. NRC Compatibility Categories A and B require that the wording of proposed State program regulatory changes should be “essentially identical”, and Category C should reflect the “essential objectives” of relevant NRC regulations. The majority of the rule changes proposed here are under NRC compatibility category B.
In 2007, the NRC promulgated changes to Title 10 of the CFR as the result of an expanded definition of byproduct material. Byproduct material was initially considered material produced by nuclear reactors, and waste product created through the process of producing material for use in reactors. Through an amendment to the Atomic Energy Act, the definition of byproduct material was subsequently widened to include materials produced through a significantly different process - accelerator-produced material - and to include discrete sources of radium-226 (a naturally occurring material).
I. Amendments for Expanded Definitions of Byproduct Material
NRC has significantly broadened its definition of byproduct material to include a wider range of radioactive materials. Byproduct material used to be defined as:
· Material made radioactive through use of nuclear fuel in a utilization facility (most often a nuclear reactor, or a strategic military device), or
· Waste products remaining after source material (e.g., refined uranium ore) is enriched2 to make it suitable for use as nuclear fuel in a reactor or as strategic military material.
The broadened definition of byproduct material in Title 10 of the CFR now includes, in addition to the above described materials, the following:
· Any discrete sources of radium-226,
· Any material which the NRC determines to pose a threat comparable to that posed by a discrete source of radium-226, or
· Material made radioactive by a particle accelerator.
Incorporating this expanded definition of byproduct material requires a number of amendments to Article 175, in particular, the following:
· §175.02 (Definitions) A number of definitions must be changed or added as a result of the new definition of byproduct material.
· §175.03 (Standards for protection against radiation) Several radioactive materials must be added to lists in appendices defining environmental release limits of radioactive material. Certain headings in these lists are to be changed.
· §175.101 (General requirements for radioactive materials licenses)
· Exemptions are proposed to cover licensing of certain items containing small quantities of radioactive material.
· Requirements are proposed to the descriptive information of material sources which an applicant for a license must provide.
· Requirements are proposed stating that an application for a license to use certain accelerator-produced material must include a request to produce those materials or provide evidence of an existing license held by its supplier of those accelerator-produced materials.
· Applicants who apply to use their own accelerator-produced radioactive drugs must provide evidence of their ability to produce those drugs.
· §175.102 (Requirements for specific types of radioactive materials licenses) New requirements are proposed for generally-licensed3 materials regarding:
· Leak testing of articles containing specified isotopes,
· Limitations on transfer of devices, and
· Records retention following transfer of disposal of devices.
· §175.104 (Waste disposal) New requirements are proposed for byproduct material regarding:
· ultimate disposal of byproduct material at waste disposal facilities.
· manifesting of byproduct material intended for transfer to waste disposal facilities.
II. Exemptions from Licensing, General Licenses and Distribution of Byproduct Material: Licensing and Reporting Requirements
NRC’s expanded definition of byproduct material has affected provisions in Article 175 regarding licensing, distribution and reporting with respect to certain classes of radioactive material or articles containing such radioactive materials. In particular, changes are proposed with respect to:
· §175.101 (General requirements for radioactive materials licenses)
· Exempt quantities may not be aggregated to the extent that combined quantities exceed the limits for exempt amounts set forth in Schedule B of this section, except for byproduct material combined within a device placed in use before May 3, 1999, or as otherwise permitted by regulation.
· Exemptions to licensing are proposed for certain specified items.
· §175.102 (Requirements for specific types of radioactive materials licenses)
· New reporting requirements are proposed with respect to persons transferring radioactive material to a licensee or shipping radioactive material for export.
In response to the 2007 NRC changes to Title 10 of the CFR concerning the changed definition of byproduct material, New York City must make matching changes to Article 175 of the Health Code to remain compatible with applicable federal regulations.
1 New York State’s agreement with NRC is available online at, http://nrc-stp.ornl.gov/special/regs/nyagreements.pdf.
2 Enrichment is a process which increases the concentration in natural uranium of the isotope U-235, which is material most suitable for fuel in a utilization facility.
3 A general license is a license granted to manufacturers to produce and distribute common articles which a user may possess without themselves requiring a radioactive materials license. Materials which are generally licensed include smoke detectors, EXIT signs, watches with luminous dials, etc.