Radioactive Materials Regulatory Revisions
6 NYCRR Part 380 - Radiation Program
Prevention and Control of Environmental Pollution by Radioactive Materials
Amendments to Part 380 - Effective May 10, 2018
6 NYCRR Part 380 applies to all State-regulated persons that dispose of or release radioactive material to the environment and sets stringent standards on the specific types of permitted radioactive releases and acceptable methods of disposal. Please refer to the Radiation Program for additional information about Part 380, including application guides for Radiation Control Permits.
On April 5, 2017, the New York State Department of Environmental Conservation (DEC) formally proposed amendments to Part 380 to incorporate eight federal rule changes that have occurred from 1991 through 2008, and to clarify and improve the existing regulation. DEC has adopted the amendments to Part 380, effective May 10, 2018.
The amendments include:
- Requiring additional information in permit applications to assist DEC in the thorough review of all required permits.
- Updating several provisions to maintain compatibility with federal regulations issued by the Nuclear Regulatory Commission, including the addition of a 10 millirem constraint on airborne emissions, a requirement which has been implemented for several years through Radiation Control Permit conditions.
- Strengthening reporting requirements to ensure DEC is alerted about incidents quickly.
- Updating language, including minor revisions to several definitions.
- Clarifying that certain types of radioactive materials are not subject to Part 380, such as household waste containing excreted residues of radiopharmaceuticals and intact smoke detectors.
- Expanding specific categories of wastes to include animal bedding that meets certain criteria, to simplify waste management practices and eliminate the need to treat animal bedding as radioactive waste.
- Adding two radionuclides (Nitrogen-13 and Oxygen-15) to the tables of concentrations.
As part of DEC's comprehensive review, public outreach was conducted to stakeholders including a public availability session and legislative public hearing on the proposed amendments, which were held in Albany on May 25, 2017. Additionally, to ensure ample time for the public to participate in the process, the public comment period was extended to July 5, 2017, 30 days beyond the initial 60-day comment period. Comments received both at the public hearing and in writing during the comment period were carefully considered as part of the amendment process. An Assessment of Public Comment was prepared to address the comments received during the public comment period.
Details of Amendments in each Subpart of Part 380
Subpart 380-1: General Provisions
- Several changes to the general provisions were made for the purpose of improving clarity and to fill regulatory gaps.
- Purpose: Reference to Article 37 of the ECL was added, as it had been previously inadvertently omitted.
- Applicability (Section 380-1.2) was revised to:
- Include the use of licensed radioactive materials (RAM) in the environment (e.g., in environmental studies). DEC could not issue Radiation Control Permits for such uses until the amendments were adopted;
- Clarify that certain types of RAM are not subject to Part 380, such as household waste containing excreted residues of radiopharmaceuticals and intact smoke detectors. This clarification should help avoid confusion about the disposal of RAM that are not subject to regulatory control;
- Clarify that sites containing buried radioactive waste are subject to Part 380; and
- Clarify that process and concentrated naturally occurring radioactive material (NORM), a regulated RAM, is also commonly referred to as technologically-enhanced NORM (TENORM).
Subpart 380-2: Definitions
Several additions and changes in definitions were be made to maintain compatibility with federal regulations, improve clarity, and incorporate commonly used terms of art.
- "Discharge" revised to apply only to the release of radioactive material to ground or surface water (term previously applied to the release of radioactive material to both air and water).
- "Disposal" added as the act of discarding material (had not previously been defined in Part 380).
- "Dose constraint" added as public dose value above which actions are required (for compatibility with federal regulations).
- "Effluent" added, to mean material released to air or water, as this term appears in the Table of Concentrations in section 380-11.7.
- "Effluent treatment" added, as it is referenced in section 380-3.4.
- "Emission" added, for the release of material to the air.
- "Incineration" revised to define process of incineration instead of the equipment used.
- "Incinerator" deleted.
- "Loss of control of radioactive material" revised, as the previous definition was limited to licensed radioactive material.
- "Permit" expanded to apply to the use of radioactive material in the environment, and for the maintenance of a former radioactive waste land burial site.
- "Permittee" revised to be consistent with language used in other DEC regulations.
- "Public Dose" added as from RAM released to the environment (for compatibility with federal regulations).
- "Release" added, as it replaces the former use of the term "discharge" throughout the regulation.
- "TENORM" added to clarify that technologically-enhanced naturally occurring radioactive material is the same as processed and concentrated naturally occurring radioactive material, which is regulated radioactive material.
- "Total effective dose equivalent" and "Member of the public" revised to maintain compatibility with federal rules.
- "Shallow dose equivalent" deleted (occupational exposure term not applicable to DEC).
- "Uncontrolled release" added for unplanned releases of radioactive material to the environment, as this term is referenced in 6 NYCRR 380-9.2 and is needed to differentiate from controlled releases of radioactive material to the environment as authorized under the Part 380 regulations.
Subpart 380-3: Permits
- Permit requirements were clarified to identify each type of disposal or release of radioactive material that can only be undertaken as authorized by DEC in a permit.
- Required content of permit applications were expanded to establish in regulation the minimum information that must be included in a permit application. These criteria will be used to evaluate the sufficiency of submitted permit applications for many years.
- Procedures for obtaining a variance were clarified and DEC may initiate such variance.
Subpart 380-4: Waste Disposal
- Language was added so that all allowed waste disposal methods for radioactive materials are referenced in this subpart.
- Disposal of specific categories of wastes (the "biomedical exemption") was expanded to include animal bedding meeting certain criteria, which supports the longstanding disposal exemption that exists for animal tissue containing small amounts of radioactive material.
Subpart 380-5: Radiation Dose Limits For Individual Members of the Public
- 10 millirem constraint on airborne emissions was added, as required to maintain compatibility with federal rules, which is lower than the current limit. This dose constraint has already been implemented by permit condition for several years.
- Reference to 40 CFR 190 was deleted, as it had been inappropriately included in Part 380 previously; that federal regulation applies to uranium fuel cycle facilities, and such facilities are not subject to Part 380.
Subpart 380-6: Surveys and Calibrations
- Annual calibrations are required for instruments used to measure effluent flow rates. This requirement has already been implemented by permit condition for several years.
Subpart 380-7: Release Minimization Programs
- No significant changes were made to this subpart.
Subpart 380-8: Records
- Regulated persons are authorized to record quantities of radioactivity in SI units, to maintain compatibility with federal rules.
- Two new requirements were added
- data maintained in electronic format must be made available to DEC via hardcopy upon request, and
- records required by Part 380 must be transferred from the old permittee to the new permittee when a permit is transferred.
- These requirements ensure that inspectors can obtain information and raw data that may only exist on a facility's computer system, and that records relevant to Part 380 compliance are properly transferred when a permit is transferred.
Subpart 380-9: Reports
- Requirement for a permittee to submit annual reports was expanded to require reporting of environmental dosimeter results when the acquisition of such data is required by the permit. This requirement has already been implemented by permit condition for several years.
- Several requirements have changed regarding notification of incidents - - some changes were required to maintain compatibility with federal regulations; other changes were added to lower the reporting thresholds, because the federal rules requiring notification of incidents only involve large radiation exposures.
- Reports are required for uncontrolled releases or events that could cause releases, or for exceedance of any permit or regulatory limit (this requirement has already been implemented by permit condition for several years), or for the exceedance of the dose constraint.
Subpart 380-10: General Regulatory Requirements
- New prohibition of engaging in deliberate misconduct is required for compatibility with federal rules, and prohibits the deliberate submission of inaccurate or incomplete information to DEC, and applies to permittees, applicants and contractors.
- Prohibition was added against uncontrolled releases, unauthorized transfers, or abandonment of radioactive material or failure to comply with any requirement in Part 380.
- Information submitted to DEC must be complete and accurate.
NOTE: These additions strengthen DEC's enforcement capabilities in the event that violations of Part 380 are identified.
Subpart 380-11: Annual Limits (Tables of Concentrations)
- Two new isotopes were added to the tables of concentrations to maintain compatibility with federal rules:
- Nitrogen-13
- Oxygen-15
Regulatory Documents
- Revised Summary of Express Terms - 6 NYCRR Part 380
- Amended Express Terms (Full Text) - 6 NYCRR Part 380 (PDF) (363 KB)
- Assessment of Public Comment Summary - 6 NYCRR Part 380 (PDF) (186 KB)
- Assessment of Public Comment - 6 NYCRR Part 380 (PDF) (693 KB)
- Revised Regulatory Impact Statement Summary - 6 NYCRR Part 380
- Revised Regulatory Impact Statement (Full Text) - 6 NYCRR Part 380 (PDF) (148 KB)
- Revised Regulatory Flexibility Analysis for Small Businesses and Local Governments - 6 NYCRR Part 380
- Revised Rural Area Flexibility Analysis - 6 NYCRR Part 380
- Revised Job Impact Exemption Statement - 6 NYCRR Part 380
- State Environmental Quality Review (SEQR) Documents - 6 NYCRR Part 380 (PDF) (1 MB) - Negative Declaration, Short Environmental Assessment Form, Coastal Assessment Form.
DMM, Bureau of Hazardous Waste and Radiation Management
625 Broadway
Albany, NY 12233