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Proposed Rules: Open to Comments

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Comment By: 
Monday, July 16, 2018
Proposed Rules Content: 
 
 

Statement of Basis and Purpose

 

Section 274 of the federal Atomic Energy Act of 1954 [42 USC §2021 et seq.] (“Atomic Energy Act”) authorizes “Agreement States” to regulate byproduct material, source material and special nuclear material in quantities not sufficient to form a critical mass.  New York State is an “Agreement State” within the meaning of the Atomic Energy Act, and the New York City Department of Health and Mental Hygiene (“Department” or “DOHMH”) operates a component of the New York State Agreement.  Under this Agreement State structure, the DOHMH, through its Office of Radiological Health (“ORH”), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City.

New York State (NYS) Public Health Law §§225(5)(p) and (q) allows the NYS Commissioner of Health and the NYS Public Health and Planning Council to establish regulations with respect to ionizing radiation and nonionizing electromagnetic radiation and to authorize appropriate officers or agencies to register radiation installations, issue licenses for the transfer, receipt, possession and use of radioactive materials, other than special nuclear materials in quantities sufficient to form a critical mass, render such inspection and other radiation protection services as may be necessary in the interest of public health, safety and welfare. The NYS regulations are set out in Part 16 of the NYS Sanitary Code.

The Sanitary Code, in 10 NYCRR §16.1(b)(3), allows New York City to establish its own radiation licensure requirements in place of State regulations, so long as the local requirements are consistent with Sanitary Code requirements. 

New York City Charter (“Charter”) Section 556(c)(11) authorizes the Department to supervise and regulate the public health aspects of ionizing radiation, the handling and disposal of radioactive wastes, and the activities within the city affecting radioactive material.   

 

Background

Article 175 of the New York City Health Code (“Health Code”) applies to all radiation-producing equipment and radioactive material within NYC.  The Article contains general provisions applicable to both radiation equipment registrants and radioactive materials licensees, and specific requirements for such equipment and materials. The purpose of Article 175 is to protect the public, as well as workers in radiation installation facilities, from the potential hazards of ionizing radiation.  The Article’s requirements for radiation control reflects the coordination of radiation control activities with the U.S. Nuclear Regulatory Commission (“NRC”), the U.S. Food and Drug Administration, the NYS Department of Health and the NYS Department of Environmental Conservation, and other relevant city, state and federal agencies.  

The proposed reenacted Article 175 of the Health Code incorporates federal requirements contained in Title 10 of the Code of Federal Regulations (“CFR”) and reflects and is consistent with state regulations contained in the NYS Sanitary Code [10 NYCRR Part 16], and sets forth ORH-specific best practices requirements.   By law, the City must maintain compatibility with applicable federal requirements and consistency with applicable state regulations.  The Health Code may, and Article 175 as proposed does, in certain instances, mandate more stringent requirements as to health and safety radiation control measures than those required by federal and state authorities.

In NYC, there are about 6500 registered facilities with radiation-producing machines and 375 licensed sites with radioactive material for medical, academic and research purposes. Of the registered facilities, approximately 6440 are diagnostic X-ray facilities and 60 are therapeutic X-ray facilities. ORH inspects these facilities at varying frequencies depending on the type of usage.  Current inspection fees are unchanged under this proposed reenactment.

Radiation equipment

Prior to this rulemaking, Article 175 of the Health Code has not been substantially updated, particularly as to its radiation equipment requirements, since its last enactment in 1994.  Similar to that last reenactment, the Department has based much of this proposed reenacted text on the model code maintained by the Conference of Radiation Control Program Directors (CRCPD). The CRCPD is a 501(c)(3) nonprofit professional organization whose primary membership is made up of radiation professionals in state and local government that regulate the use of radiation sources in their jurisdictions.  CRCPD's mission is "to promote consistency in addressing and resolving radiation protection issues, to encourage high standards of quality in radiation protection programs, and to provide leadership in radiation safety and education".[1]  Since the reenactment of Article 175 in 1994, improved best practices have been developed and implemented for radiation control measures.  Many of these measures are reflected in the current CRCPD model code, which has provided the basis for much of the text related to radiation equipment in the new proposed Article 175.

Radioactive materials

As noted above, Article 175 of the Health Code incorporates federal requirements from Title 10 of the CFR.  New York State is an Agreement State with the U.S. NRC which means that the NRC has delegated authority to NYS to regulate radioactive material at non-reactor sites within its jurisdiction.  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 NYS Agreement and § 16.1 of the State Sanitary Code, the Department, through its Office of Radiological Health (ORH), regulates radioactive material for medical, research and academic purposes within the five boroughs of New York City.  Each Agreement State program is required to maintain compatibility with the NRC regulatory program. The NRC regulatory program utilizes Compatibility Categories to specify the type of wording to be used in the corresponding State program regulations.[2]

 

As noted above, the last significant revision of Article 175 requirements occurred over 20 years ago.  Since then, NRC has made numerous updates of its requirements contained in Title 10 of the CFR.  In order for the Department to maintain its compatibility status with the NRC regulatory program, each time the NRC has updated its regulations in Title 10 of the CFR, the Board has had to make corresponding updates to Article 175, which has been an inefficient and time–consuming process.  In many instances, and because of the compatibility designations, the Board updated Article 175 by reproducing the actual CFR text directly into its requirements. The Board believes that continuing to update its rules this way is redundant and unnecessary and that it makes more sense to incorporate by reference the relevant CFR regulations, which will still provide the same legal force and effect as if the Board had actually reproduced such requirements directly into Article 175.  This incorporation by reference process avoids duplication and provides uniform, accurate guidance to the regulated community, as well as making for a less unwieldy and more manageable Code.

Accordingly, the Department proposes the Board repeal and reenact Article 175 primarily to:

  • update the quality assurance requirements to reflect industry-wide best practices for the installation, operation and maintenance of  both diagnostic and therapeutic radiation equipment required to be registered with the Department, and which is used for medical, academic and research purposes, and
  • more efficiently adopt and enforce NRC requirements for the possession and use of radioactive materials required to be licensed by the Department by incorporating by reference applicable federal regulations contained in Title 10 of the CFR for radioactive materials.

Statutory Authority

This repeal and reenactment of Article 175 of the Health Code is proposed pursuant to Sections 556, 558 and 1043 of the Charter and applicable state and federal law.  Section 556 of the Charter grants the Department jurisdiction to regulate matters affecting health in New York City.  Specifically, Section 556(c)(11) of the Charter authorizes the Department to supervise and regulate the public health aspects of ionizing radiation within the five boroughs of New York City.  Sections 558(b) and (c) of the Charter empower the Board of Health to amend the Health Code and to include in the Health Code all matters to which the Department’s authority extends.  Section 1043 of the Charter grants rule-making powers to the Department.

 




[1] See, http://c.ymcdn.com/sites/www.crcpd.org/resource/collection/665D6792-2EB4-4AF6-8134-1173A394FE28/Constitution10-25-04.pdf (describing the goals of the CRCPD to, among other things, promote radiological health in all aspects and phases and to promote and foster uniformity of radiation control laws and regulations).

[2] See, https://scp.nrc.gov/procedures/sa200.pdf  (providing NRC compatibility categories and health and safety components assigned for determining whether an agreement state is maintaining a compatible radiation safety control program with NRC).

 
 
Subject: 

Proposed resolution to repeal and reenact Article 175 (Radiation Control) of the New York City Health Code

Location: 
New York City Department of Health and Mental Hygiene, Gotham Center
42-09 28th Street 14th Floor, Room 14-43
Queens, NY 11101
Contact: 

Svetlana Burdeynik, (347) 396-6078, resolutioncomments@health.nyc.gov

Download Copy of Proposed Rule (.pdf):