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Regulatory Impact Statement Summary - 6 NYCRR Part 380

Amendments to 6 NYCRR Part 380 - Prevention and Control of Environmental Pollution by Radioactive Materials

1. Statutory Authority

The New York State Department of Environmental Conservation (DEC) regulates the disposal and release of radioactive material to the environment pursuant to Articles 1, 3, 17, 19, 27, 29, and 37 of the Environmental Conservation Law (ECL) and the State of New York's agreement with the United States Nuclear Regulatory Commission (NRC).

New York State Agreement State Program

The Atomic Energy Act (AEA) of 1954 created the federal program for controlling the use of most radioactive materials and for limiting the public exposure to radiation resulting from that use. In 1960, the AEA was amended to allow states to enter into agreements with the NRC whereby the authority to license most uses of radioactive material is relinquished to the state. New York State became an Agreement State in 1962. The State's agreement is implemented by the New York State Department of Health (DOH), the New York City Department of Health and Mental Hygiene (NYCDHMH), and DEC.

ECL Articles 1 and 3

The ECL vests in DEC broad powers with respect to the discharge of pollutants into the environment. Those powers are set forth in ECL section 1-0101(1). DEC further implements this policy by ECL section 3-0301(1). There is not a separate ECL Article that comprehensively governs the regulation of radioactive materials. Rather, the source of legal authority is divided among the following ECL Articles: Article 17 (Water), Article 19 (Air), and Article 27 (Solid Waste), Article 29 (Low-Level Radioactive Waste Facilities), and Article 37 (Substances Hazardous or Acutely Hazardous to Public Health, Safety or the Environment).

2. Legislative Objectives

Part 380 contributes to meeting the legislative goals of conserving, improving, and protecting the State's natural resources and environment and preventing, abating, and controlling water, land, and air pollution.

The amendments do not change the current requirements governing the disposal of radioactive material, obtaining permits for releases of radioactive material to the environment, or the requirement that exposures be kept as low as reasonably achievable. New provisions that contribute to meeting the legislative goals include applying a constraint on emissions to the air, which is lower than the prior limit.

3. Needs and Benefits

The purpose of Part 380 is to control the release of radioactive material to the environment in order to protect the public health and the environment. The regulations apply to all State-regulated parties that dispose of or release radioactive materials to the environment.

These amendments are needed because of New York State's agreement with the NRC: the State is required to have regulations that are compatible with the federal regulations. This amendment is needed to incorporate applicable federal changes to 10 CFR 20, the federal standards for protection against radiation, that were made from 1991 through 2008.

The amendments also simplify language, define commonly used terms of art, and clarify several regulatory provisions. These clarifications benefit the regulated community whose operations are regulated by Part 380, and strengthen DEC's enforcement capabilities regarding these regulatory provisions.

In subpart 380-1, several changes to the general provisions have been made for the purpose of improving clarity and to fill regulatory gaps.

In subpart 380-2, several additions and changes to the definitions have been made to maintain compatibility with federal regulations, improve clarity, and incorporate commonly used terms of art.

In subpart 380-3, permit requirements have been clarified to identify each type of disposal or release of radioactive material that can only be undertaken as authorized in a permit. Also, the required content of permit applications have been expanded to establish the minimum information that must be included in a permit application.

In subpart 380-4, language has been added so that all allowed waste disposal methods are referenced in this subpart.

In subpart 380-5, a 10 millirem (mrem) constraint on airborne emissions has been added, as required to maintain compatibility with federal regulations.

In subpart 380-6, annual calibrations are required for instruments used to measure effluent flow rates.

No significant changes were made to subpart 380-7.

In subpart 380-8, regulated parties are authorized to record quantities of radioactivity in SI units. Also, two new requirements have been added: (1) data maintained in electronic format must be made available to DEC via hardcopy upon request, and (2)records required by Part 380 must be transferred from the old permittee to the new permittee when a permit is transferred.

In subpart 380-9, the requirement for a permittee to submit annual reports has been expanded to require reporting of environmental dosimeter results when the acquisition of such data is required by the permit. Several requirements have changed regarding Notification of Incidents - - some changes were required to maintain compatibility with federal regulations; others were made to lower the reporting thresholds.

In subpart 380-10, several additions have been made to the General Regulatory Requirements. The new prohibition of engaging in deliberate misconduct is required for compatibility with federal regulations. Also, information submitted to DEC must be complete and accurate, and a prohibition has been added against uncontrolled releases, unauthorized transfers, or abandonment of radioactive material, or failure to comply with any requirement in Part 380.

In subpart 380-11, two new isotopes have been added to the Tables of Concentrations: N-13 and O-15. These additions are required to maintain compatibility with federal regulations.

4. Costs

Costs to Regulated Parties:

Part 380 applies to all state-regulated parties that use or dispose of radioactive material in quantities and concentrations that are subject to regulation by the licensing agencies of New York State (i.e., DOH and NYCDOHMH).

In 2012, there were 28 persons holding one or more Part 380 permits. Those 28 permittees held a total of 30 permits: 1 for the incineration of radioactive material, 26 for releases to the air, 1 for discharges to surface water, and 2 for the maintenance of former radioactive waste burial sites.

There should be no additional costs to regulated persons due to the requirements to meet the 10 mrem dose constraint on airborne emissions or to report environmental dosimeter results in their annual reports, because permittees have already been subject to this requirement via permit condition for several years. There may be some additional costs to regulated persons due to the lower threshold for reporting of incidents, via expenditure of staff time to prepare and submit reports of incidents and follow up actions.

Costs to the Department, State, and Local Government:

DEC will expend resources and staff time preparing to implement the amendments. Guidelines and explanatory documents distributed to regulated persons must be written, and staff must be trained in the implementation of the revised regulations. This will require several months of staff time. After the initial preparation and training period, the routine implementation of the amended regulations is not expected to cost more (on a cost per regulated person basis) than the implementation of the current Part 380 program.

In addition to the cost to DEC, the other State agency in the Agreement State program, DOH, will expend some staff time becoming familiar with DEC's amended regulation. This may require one or two days of staff time. At least two state agencies and one campus of the state university system have been issued Part 380 permits. Their costs as regulated persons are described above.

The amendments do not place any requirements directly on local governments, except where local governments operate facilities that possess radioactive material. In that case, the cost to the local government is the same as that to other regulated parties. Currently, none of the entities that have been issued Part 380 permits are owned by local governments.

NYCDHMH, as one of the three Agreement State agencies in New York State, will probably expend one or two staff days becoming familiar with the revised Part 380.

5. Local Government Mandates

The adoption of the amendments do not place any mandates on local governments except for those local governments operating facilities that are regulated parties. In those cases, local governments must meet the requirements placed on all regulated parties. Because control of radioactive materials is preempted by the federal government and only relinquished to Agreement States, local governments, other than New York City, have no regulatory responsibilities over the release or disposal of radioactive materials.

6. Paperwork

Several provisions in the amendments require the preparation and submission of additional paperwork. The amendment clarifies the information that must be included in a permit application. The implementation of lower thresholds for notification of incidents requires reports to be submitted for uncontrolled releases or events that could cause releases, exceedance of any permit or regulatory limit, or exceedance of the dose constraint. The required submission of annual reports has been expanded to include reporting of environmental dosimeter results from permittees whose permit requires the aquisition of environmental dosimetry data.

7. Duplication

The New York State Agreement State program is divided among three agencies. The two agencies other than DEC have the authority to license the possession and use of radioactive materials. It is only when that material is disposed of or released to the environment that it comes under the jurisdiction of DEC. Thus, there is no overlap between the regulatory programs of the licensing agencies and that of DEC.

Because the amendments to Part 380 must be compatible with 10 CFR, many sections in Part 380 are identical, or very similar, to the federal rules. However, 10 CFR applies to federally-regulated facilities, while Part 380 applies to state-regulated facilities, and thus there is no duplication of regulation.

8. Alternatives

The alternatives available to DEC in developing the amendments to Part 380 were limited by its role as an Agreement State agency. As explained above, an Agreement State's regulations must be compatible with 10 CFR, and be adopted essentially verbatim.

Because DEC's regulations must be compatible with NRC's regulations, DEC was precluded from considering alternatives to them. The affected provisions are definitions, dose limits, notification of incidents, the constraint rule, deliberate misconduct, and the addition of O-15 and N-13 to the Tables of Concentrations. Thus, DEC did not consider alternatives to those provisions of the rule.

For those portions of the amendments that are required by federal rule, taking the no-action alternative would not be consistent with New York State's agreement with the NRC. If Part 380 is not revised, not only would it be obsolete, but it would be inconsistent with the regulations of the radioactive materials licensing agencies in New York State. Thus, not revising Part 380 for compatibility with federal rules could jeopardize New York's agreement with NRC.

For those changes that were not based on federal rules, taking the no-action alternative would result in not simplifying regulatory language, not clarifying regulatory provisions, and not filling regulatory gaps which had become apparent through years of implementing the existing Part 380 regulations.

9. Federal Standards

The amendments are more stringent than federal regulations regarding several requirements for reporting of incidents. The amendments require reporting of uncontrolled releases of radioactive material or events that could cause releases or the exceedance of any regulatory limit. These provisions are more restrictive than the federal rules, which require reporting only when dose limits are greatly exceeded. Lower severity events are more common, but are not currently required to be reported. The amendments require lower severity events to be reported; facility compliance with this new requirement enables DEC to ensure that prompt and appropriate actions are taken to resolve such events.

10. Compliance Schedule

Section 380-1.5 establishes the transition rules for these amendments. In general, all provisions in the amendments become effective on the effective date of the rulemaking. The new 10 mrem dose constraint on airborne emissions has already been in effect as a permit condition for several years. Permittees have also been required to report environmental dosimetry results in their annual reports and report the exceedance of any permit limit, in accordance with permit conditions, for several years.

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