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Regulatory Flexibility Analysis for Small Businesses and Local Governments - 6 NYCRR Part 380

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

1. Effect of Rule

The proposed amendments to 6 NYCRR Part 380 would affect small businesses that release radioactive material to the environment. (Small businesses that possess radioactive material in a form that is not normally released to the environment are only subject to the disposal restrictions in the existing Part 380. These requirements will not be changed by the Part 380 amendments.) Affected parties may include such small businesses as medical practices, radioactive waste brokers, small research or diagnostic laboratories, radioisotope production facilities, and manufacturers that use radioactive material in their production or quality control processes.

Only one of the parties that currently have a Part 380 permit is a small business. It is a company that produces isotopes for use in medical imaging. Another type of small business that would be affected by this regulation is health physics consultants that may be hired by regulated parties to assist in implementing these amendments. These businesses may benefit from increased business due to these proposed amendments, although they would also need to invest time and resources in becoming familiar with the new rules.

2. Compliance Requirements

The current Part 380 sets limits on the radiation dose to members of the public that could be received from the release of radioactive material to the environment. Regulated parties must restrict their releases so that those dose limits are not exceeded. The proposed amendments to Part 380 add a new 10 millirem dose constraint for members of the public that could result from radioactive airborne emissions in one year. Regulated parties are not expected to have to change their operations to comply with this amendment because the doses from all currently regulated releases are already below the proposed new dose constraint. Part 380 Radiation Control Permitees have already been subject to the 10 millirem dose constraint by a permit condition for the past several years.

The proposed amendments lower the reporting threshold requiring regulated parties to notify the New York State Department of Environmental Conservation (DEC) of any release of radioactive material to the environment. Reports would be required for uncontrolled releases or events that could cause releases, for exceedance of any permit or regulatory limit, or for exceedance of the dose constraint; the contents of reports and timeframes are specified in the proposed amendments.

The proposed amendments expand the requirement for permitees to submit annual reports to also require reporting of environmental dosimeter results when the acquisition of such data is required by the permit. Regulated parties are not expected to have to change their operations to comply with this amendment because this requirement has already been implemented by a permit condition for several years.

The proposed amendments expand the requirement for annual calibration of radiation detection instruments to include instruments used to measure effluent flow rates. Permittees are not expected to have to change their operations to comply with this amendment because this requirement has already been implemented by a permit condition for several years.

3. Professional Services

The proposed amendments to Part 380 do not set any requirements that require any professional services beyond those needed to comply with the current Part 380. To comply with the existing regulations, regulated parties should have on staff one or more professionals knowledgeable in the principles of health physics, radiation protection, and control and monitoring of releases to the environment. In the past, some small businesses have hired consultants to prepare part or all of their permit applications. This practice is expected to continue after the regulations have been amended.

4. Compliance Costs

The proposed amendments to Part 380 include a 10 millirem dose constraint for members of the public that could result from radioactive emissions to the air. No regulated party will have to make any initial capital or non-capital investments to meet this requirement as they are already complying with the 10 millirem dose constraint.

The proposed amendments lower the reporting threshold requiring regulated parties to notify DEC of any uncontrolled release of radioactive material to the environment. This requirement will result in expenditure of staff time to prepare and submit reports of incidents and conduct follow up actions, should a reportable incident occur. Historically, such reports have usually been voluntarily submitted by permittees, as good practice. A reportable incident would require several hours to investigate, document, and institute corrective actions; such work would likely be conducted by the facility's on-site radiation protection staff. Such incidents do not occur frequently.

The proposed amendments expand the requirement for permittees to submit annual reports to also require reporting of environmental dosimeter results when the acquisition of such data is required by the permit. There will be no increase in costs to regulated parties as they are already complying with this requirement.

The proposed amendments expand the requirement for annual calibration of radiation detection instruments to include instruments used to measure effluent flow rates. There will be no increase in costs to regulated parties as they are already complying with this requirement.

5. Economic and Technological Feasibility
Implementation of the proposed amendments would be economically and technologically feasible for small business and local governments. Regulated parties currently manage the possession, use and disposal of radioactive material in accordance with a host of existing regulatory requirements which address the sufficiency of facilities, equipment, and staff expertise necessary to conduct operations safely. Most of the changes proposed in the amendments to Part 380 are already being met by regulated parties by permit conditions, thus demonstrating that the proposed amendments are economically and technologically feasible.

6. Minimizing Adverse Impact

The provisions in the proposed amendments to Part 380 would not have an adverse impact on small businesses, as most provisions are already being met by regulated parties. DEC did not have the option of relaxing these requirements for small businesses. The alternatives available to DEC in writing the proposed amendments to Part 380 are limited by DEC's status as an Agreement State agency. Under New York State's (State) agreement with the United States Nuclear Regulatory Commission (NRC), in which NRC has relinquished its authority to regulate the use and possession of most radioactive material to the State, DEC's Part 380 regulations must be compatible with the federal regulations promulgated by the NRC.

7. Small Business and Local Government Participation

As a public outreach initiative in early 2010, information on this rulemaking was mailed to all Part 380 permittees and applicants, radioactive materials licensees, and environmental and public interest groups in the State. Also, a preliminary draft of the amendment was posted on DEC's website and a notice was published in the Environmental Notice Bulletin.

8. Cure period or Other Opportunity for Ameliorative Action

DEC does not believe that there is a need for a cure period for the proposed Part 380. Significant proposed amendments (summarized below) are already implemented, as these requirements have been included as permit conditions for the past several years. Such amendments required by a permit condition are: (1) 10 millirem dose constraint for members of the public that could result from radioactive airborne emissions in one year; (2) notification of uncontrolled release, or incidents that are in exceedance of any permit or regulatory limit; (3) annual reporting of environmental dosimeter results when a permit requires acquisition of such data; and (4) annual calibration of instruments used to measure effluent flow rates. Since these requirements are already provided as permit conditions, they are not imposed to the regulated community without prior notice and a cure period is not needed. The regulated community would be required to comply with the proposed amendments upon the effective date, which is 30 days after DEC files the Notice of Adoption with the State Department of State. Furthermore, no new penalties are created by proposed Part 380 because enforcement is governed by statutory language which is set forth in Article 71 of the Environmental Conservation Law.


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