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Differences in Agreement States Implementation of Regulations Equivalent to 10 CFR 31.6 Sean C. Chapel, President The 53rd Annual Meeting of the Health.

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Presentation on theme: "Differences in Agreement States Implementation of Regulations Equivalent to 10 CFR 31.6 Sean C. Chapel, President The 53rd Annual Meeting of the Health."— Presentation transcript:

1 Differences in Agreement States Implementation of Regulations Equivalent to 10 CFR 31.6 Sean C. Chapel, President The 53rd Annual Meeting of the Health Physics Society July 13-17, 2008, Pittsburgh, PA

2 Abstract Many Agreement States have incorporated the provisions of U.S. Nuclear Regulatory Commission (U.S. NRC) regulation 10 CFR 31.6 into their regulations allowing licensed distributors and their representatives to service devices containing radioactive sources regulated under 10 CFR 31.5 (Generally Licensed Devices) without the need to apply for reciprocity. However, as a matter of policy some Agreement States who have adopted these regulations do not allow work to be conducted in their jurisdiction without first filing for reciprocity. This is an apparent conflict between the stated regulation and policy. The reasons for these policy decisions are not clear and consistent across the U.S., and it would be beneficial to have a national dialog to resolve these differences. Many Agreement States have incorporated the provisions of U.S. Nuclear Regulatory Commission (U.S. NRC) regulation 10 CFR 31.6 into their regulations allowing licensed distributors and their representatives to service devices containing radioactive sources regulated under 10 CFR 31.5 (Generally Licensed Devices) without the need to apply for reciprocity. However, as a matter of policy some Agreement States who have adopted these regulations do not allow work to be conducted in their jurisdiction without first filing for reciprocity. This is an apparent conflict between the stated regulation and policy. The reasons for these policy decisions are not clear and consistent across the U.S., and it would be beneficial to have a national dialog to resolve these differences.

3 Reciprocity Commission recognition of certain Agreement State licenses for work performed in areas of NRC jurisdiction. This term is also used in Agreement States with regard to Agreement State recognition of NRC licenses, as well as licenses from other Agreement States for work performed within their jurisdiction. Commission recognition of certain Agreement State licenses for work performed in areas of NRC jurisdiction. This term is also used in Agreement States with regard to Agreement State recognition of NRC licenses, as well as licenses from other Agreement States for work performed within their jurisdiction.

4 General License NRC Regulation 10 CFR (b), Types of Licenses, defines a general license asprovided by regulation, grants authority to a person for certain activities involving byproduct material, and is effective without the filing of an application with the Commission or the issuance of a licensing document to a particular person. However, registration with the Commission may be required by the particular general license. NRC Regulation 10 CFR (b), Types of Licenses, defines a general license asprovided by regulation, grants authority to a person for certain activities involving byproduct material, and is effective without the filing of an application with the Commission or the issuance of a licensing document to a particular person. However, registration with the Commission may be required by the particular general license.

5 Summary of Issue Many Agreement States have adopted regulations equivalent to NRC 10 CFR Many Agreement States have adopted regulations equivalent to NRC 10 CFR Allows distributors and their representatives to service devices containing radioactive sources regulated under 10 CFR 31.5 (Generally Licensed Devices) without reciprocity. Allows distributors and their representatives to service devices containing radioactive sources regulated under 10 CFR 31.5 (Generally Licensed Devices) without reciprocity.

6 10 CFR 31.6 U.S. NRC Regulation 10 CFR 31.6, General License to Install Devices Generally Licensed in §31.5, states the following: U.S. NRC Regulation 10 CFR 31.6, General License to Install Devices Generally Licensed in §31.5, states the following: Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, install, or service a device described in § 31.5 within such Agreement State is hereby granted a general license to install and service such device in any non-Agreement State… Any person who holds a specific license issued by an Agreement State authorizing the holder to manufacture, install, or service a device described in § 31.5 within such Agreement State is hereby granted a general license to install and service such device in any non-Agreement State…

7 Three Circumstances Issues fall under three circumstances: Agreement States which have adopted 10 CFR 31.6 and honor the spirit of the regulations Agreement States which have adopted 10 CFR 31.6 and honor the spirit of the regulations Agreement States which have adopted 10 CFR 31.6 but as a matter of policy still require reciprocity to be filed. Agreement States which have adopted 10 CFR 31.6 but as a matter of policy still require reciprocity to be filed. Agreement States which have refused to adopt 10 CFR 31.6 Agreement States which have refused to adopt 10 CFR 31.6

8 Focus is on A.S. with Policy Differences Since states in the first category are not an issue, and states in the last category are clear in their objections, the primary focus of this talk is on the middle group of Agreement States which have policy differences with their own regulations. Since states in the first category are not an issue, and states in the last category are clear in their objections, the primary focus of this talk is on the middle group of Agreement States which have policy differences with their own regulations.

9 Not Implementing 10 CFR 31.6 Some state regulations indicate that GL Devices may be serviced in their state under general license, however the regulators will still require service providers to file for reciprocity. In this case states have adopted the language of the NRC regulations but are not implementing the spirit of the regulation. Some state regulations indicate that GL Devices may be serviced in their state under general license, however the regulators will still require service providers to file for reciprocity. In this case states have adopted the language of the NRC regulations but are not implementing the spirit of the regulation.

10 Rationale Behind Reciprocity Requirements The purpose of reciprocity is to ensure that activities involving the use of radioactive materials or devices are carried out within an NRC Agreement State by licensed individuals. The purpose of reciprocity is to ensure that activities involving the use of radioactive materials or devices are carried out within an NRC Agreement State by licensed individuals. It also prevents the requirement for filing for a new license in each state. It also prevents the requirement for filing for a new license in each state.

11 Different A.S. Have Different Requirements Some Agreement States ask more specific questions when it comes to reciprocity. For example: Are you bringing a radioactive source into the state? (whether for calibration of re-sourcing) Are you bringing a radioactive source into the state? (whether for calibration of re-sourcing) Will you be servicing and/or wipe testing a device? (if you do not touch the source then there may not be a reciprocity requirement) Will you be servicing and/or wipe testing a device? (if you do not touch the source then there may not be a reciprocity requirement)

12 Asking the Right Questions Sometimes whether or not vendors are required to file for reciprocity is not only dependent upon the questions regulators ask, but the clarifications of requirements asked by vendors. Sometimes whether or not vendors are required to file for reciprocity is not only dependent upon the questions regulators ask, but the clarifications of requirements asked by vendors.

13 Independent GL Service Providers There is evidence that the number of independent GL Service providers has been slowly decreasing over the last decade. The regulatory barriers of Agreement States and high reciprocity fees are suspected to be part of this cause. There is evidence that the number of independent GL Service providers has been slowly decreasing over the last decade. The regulatory barriers of Agreement States and high reciprocity fees are suspected to be part of this cause.

14 Remove Regulatory Barriers It is in the public interest to remove regulatory barriers for service providers. This is especially important for end users whos manufacturers are no longer in business. It is in the public interest to remove regulatory barriers for service providers. This is especially important for end users whos manufacturers are no longer in business. These companies have special knowledge for repairing existing older devices whos manufacturers may no longer be in business. These companies have special knowledge for repairing existing older devices whos manufacturers may no longer be in business.

15 Written Reciprocity Guidelines Some Agreement States have inconsistent policies when it comes to Reciprocity Requirements (you can get different answers from the same organization) Some Agreement States have inconsistent policies when it comes to Reciprocity Requirements (you can get different answers from the same organization) It would make sense for Agreement States to have written guidelines available to the public as to how regulations related to reciprocity are implemented. It would make sense for Agreement States to have written guidelines available to the public as to how regulations related to reciprocity are implemented.

16 Registration Alternative Some states have indicated that the purpose of reciprocity is to track out-of- state companies in their state. Some states have indicated that the purpose of reciprocity is to track out-of- state companies in their state. Alternatively this can be done by using a vendor registration system. This works because companies are still required by many regulations to report the repair and servicing of individuals devices in their Agreement State. Alternatively this can be done by using a vendor registration system. This works because companies are still required by many regulations to report the repair and servicing of individuals devices in their Agreement State.

17 Summary States which have already adopted 10 CFR 31.6 should carry out its intended purpose as a matter of policy States which have already adopted 10 CFR 31.6 should carry out its intended purpose as a matter of policy Vendor registration is an acceptable alternative to reciprocity without the large fees and regulatory burdens Vendor registration is an acceptable alternative to reciprocity without the large fees and regulatory burdens

18 References Organization of Agreement States (OAS), Petition for Rulemaking, June 27, Organization of Agreement States (OAS), Petition for Rulemaking, June 27, NRC 10 CFR 31.6 NRC 10 CFR 31.6 NRC NUREG-1556, Vol. 19 NRC NUREG-1556, Vol. 19 NRC FSME , September 27, 2007 NRC FSME , September 27, 2007


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