05-778. Sander C. Perle, ICN Worldwide Dosimetry; Denial of Petition for Rulemaking

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Petition for rulemaking; Denial.

SUMMARY:

The Nuclear Regulatory Commission (NRC) is denying a petition for rulemaking submitted by Sander C. Perle, ICN Worldwide Dosimetry (now Global Dosimetry Solutions, Inc.) (PRM-20-25). The petitioner requested that the NRC amend its regulations to require that any dosimeter, without exception, that is used to report dose of record and demonstrate compliance with the dose limits specified in the Commission's regulations be processed and evaluated by a dosimetry processor holding accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; the definition of “Individual monitoring devices” (individual monitoring equipment) be revised to mean any device used by licensees to show compliance with the Commission's regulations; and “electronic dosimeters and optically stimulated dosimeters” be added as additional examples of individual monitoring devices.

ADDRESSES:

Copies of the petition for rulemaking, the public comments received, and the NRC's letter to the petitioner are available for public inspection and/or copying in the NRC Public Document room, 11555 Rockville Pike, Rockville, Maryland. These same documents are also available on the NRC's rulemaking Web site at http://ruleforum.llnl.gov. For information about the interactive rulemaking Web site, contact Carol Gallagher, [phone], e-mail: [e-mail].

The NRC maintains an Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. These documents may be accessed through the NRC's Public Electronic Reading Room on the Internet at http://www.nrc.gov/​reading-rm/​adams.html. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to [e-mail]. Note: Public access to documents, including access via ADAMS and the PDR, has been temporarily suspended so that security reviews of publicly available documents may be performed and potentially sensitive information removed. However, access to the documents identified in this Federal Register continues to be available through the rulemaking Web site at http://ruleforum.llnl.gov, which was not affected by the ADAMS shutdown. Please check with the listed NRC contact concerning any issues related to document availability.

FOR FURTHER INFORMATION CONTACT:

Torre Taylor, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The Petition

On May 5, 2003 (68 FR 23618), the NRC published a notice of receipt of a petition for rulemaking filed by Sander C. Perle, ICN Worldwide Dosimetry (now Global Dosimetry Solutions, Inc.). The petitioner requested that the NRC amend its regulations to require that any dosimeter, without exception, that is used to report dose of record and demonstrate compliance with the dose limits specified in the Commission's regulations be processed and evaluated by a dosimetry processor holding accreditation from NVLAP; the definition of “Individual monitoring devices” [in 10 CFR 20.1003] (hereafter, “10 CFR Section” referred to as §) (individual monitoring equipment) be revised to mean any device used by licensees to show compliance with § 20.1201; and “electronic dosimeters and optically stimulated dosimeters” be added as additional examples of individual monitoring devices in the definition of “Individual monitoring devices.”

The petitioner stated that the current wording of § 20.1501©) precludes testing and accreditation requirements for an electronic dosimeter. The petitioner also stated that today's electronic dosimeters use multiple microprocessors that include many complex user input parameters that ultimately affect the final dose and/or dose rate reported. The dose determined from an electronic dosimeter is a “processed” dose. The electronic dosimeter requires that the licensee program the dosimeter to respond to various spectra, based on the calibration and other licensee set parameters. According to the petitioner, the NRC's position is that, because the current § 20.1501(c) does not appear to include the definition of an electronic dosimeter, nothing prohibits a licensee from using an electronic dosimeter to establish a dose of record. The petitioner states that the NRC's philosophy is that the NRC onsite inspector can assess the validity of the electronic dosimeter quality assurance program. The petitioner believes that the NVLAP onsite assessor [the NVLAP onsite assessor who inspects the facility requesting accreditation] is the most appropriate individual to assess a facility's quality assurance program, and to determine if the electronic dosimeter is capable of measuring and reporting accurate and precise dose results for workers in a specific radiation work environment, as the NVLAP onsite assessor does for all other NVLAP accredited whole body dosimeters.

The petitioner also stated that the current wording of § 20.1501(c) precludes testing and accreditation requirements for an extremity dosimeter (finger or wrist dosimeter). The petitioner states that because § 20.1201, Occupational dose limits for adults, specifies a dose limit, including the annual limits to the extremities, which are a shallow dose equivalent of 50 rems (0.5 Sv) to the skin or to an extremity, it would seem logical that the dosimeter used to make this dose determination should be accredited through the same process as a whole body dosimeter. The petitioner indicated that NVLAP has accredited [processors of] extremity dosimeters per American National Standards Institute (ANSI) standard N13.32-1995, “Performance Testing of Extremity Dosimeters,” for the past 8 years. The petitioner believes that there is no reason to continue to exclude [processors of] extremity dosimeters from required NVLAP accreditation.

The petitioner believes that requiring NVLAP accreditation [for the use] of electronic dosimeters provides an unbiased third-party evaluation and recognition of performance, as well as expert technical guidance to upgrade laboratory performance. NVLAP accreditation signifies that a laboratory has demonstrated that it operates in accordance with NVLAP management and technical requirements pertaining to quality systems; personnel; accommodation and environment; test and calibration methods; equipment; measurement traceability; sampling; handling of test and calibration items; and test and calibration reports. NVLAP accreditation does not imply any guarantee (certification) of laboratory performance or test/calibration data; it is solely a finding of laboratory competence.

Public Comments on the Petition

The notice of receipt of the petition for rulemaking invited interested persons to submit comments. The petition was docketed as PRM-20-25. The petition was published in the Federal Register on May 5, 2003 (68 FR 23618), for a 75-day comment period. The comment period closed on July 21, 2003. NRC received nine comment letters from utilities, industry, the public, and a State radiation control program. NRC also received three comment letters from the petitioner, in response to public comments NRC received regarding the petition. Six commenters recommended that NRC deny the petition, three commenters supported the petition, but with substantial changes, and three comments were received from the petitioner responding to comments that the NRC received on the petition. The majority of the commenters opposed the petition. Two commenters agreed with the intent of the petition; however, they had concerns with the proposed regulatory language. Several commenters noted that the proposed revision would require NVLAP accreditation [of processors] for all dosimeters, including dosimeters that are used as backup dosimeters. [Note that the terms “secondary” and “backup dosimetry” are used by the commenters. NRC does not have a definition for “secondary” or “backup dosimetry.”] Some commenters indicated that electronic dosimeters are control devices for real-time exposure information and should not be subject to NVLAP accreditation for the processor. The concern is that licensees might then issue only one NVLAP accredited dosimeter and remove the redundancy now in place with wearing a second dosimeter.

Cost was a major issue with the commenters. One commenter believes the proposed revision could force a licensee to hire a third party to oversee and implement its use of electronic dosimeters. Others commented that NVLAP testing costs would at least double. Some commenters believe that the cost of accreditation does not warrant the benefit of having all dosimeters evaluated by a NVLAP accredited dosimetry processor. Several commenters believed that the proposed revision would impose additional burden that is unnecessary and unjustified.

One commenter questioned the petitioner's statement that electronic dosimetry is processed. One commenter questioned the availability of a viable standard for electronic dosimetry upon which to base NVLAP testing.

Regarding the petitioner's proposed change to require NVLAP accreditation for processors of extremity dosimetry, one commenter indicated that the current standard for extremity dosimetry, ANSI/Health Physics Society (HPS) N13.32-1995, “Performance Testing of Extremity Dosimeters,” is undergoing a major revision, and that NRC should defer any rulemaking on this issue until the revision of this standard is completed.

One commenter believes that the proposed revision represents a backfit requirement and that it would impose new requirements on licensees with an additional burden to revise programs and procedures, and to provide training. Many commenters believe that the current programs for monitoring and recording occupational radiation dose are adequate to assure protection of worker health and safety and did not believe the petitioner provided information to the contrary. One commenter did not believe that the petition described a regulatory problem or issue in the current program and that the proposed revision only provided an enhancement to the regulations. One commenter stated that: “There are certain situations where NVLAP accreditation is not available for all neutron fields. * * * the proposal would leave no compliance option for licensees with radiation fields beyond the standard NVLAP parameters.” Another commenter indicated that the proposed revision would empower NVLAP to dictate to the licensee the categories for which testing would be required.

The petitioner provided three comments in response to public comments that were submitted to NRC, which are summarized as follows. The petitioner stated that the intent of the petition is for the proposed revisions to apply only to the primary dosimeter, and not to the secondary dosimeter. [Note that the terms “primary” and “secondary” are used by the petitioner; NRC does not have a definition of these terms in its regulations. The NRC staff understands that the petitioner means the “primary” dosimeter as the dosimeter that provides the “dose of record” and that the “secondary” dosimeter is the “backup” dosimeter.] The petitioner disagreed with a comment that no compliance options are left for licensees with radiation fields beyond NVLAP parameters. A facility would test in those radiation categories that are representative of the radiation field to which its employees are exposed. The petitioner also stated that if the petition was not approved, the extremity ring or wrist dosimeters would continue to be worn with no requirement that they be tested under any proficiency testing program.

Reasons for Denial

After reviewing the petition and the public comments, the NRC is denying the petition. NRC has determined that the current NRC regulations are adequate to protect worker and public health and safety. The NRC is denying the petition because there is insufficient evidence that it solves a regulatory problem or improves health and safety. The additional requirements would be an increase in burden for licensees who have their own accreditation, and for processors, without a commensurate benefit of increased protection of worker health and safety. The increase in burden would be from the additional resources for the NVLAP accreditation process, which includes the accreditation fee, as well as the staff time to go through the accreditation process, which includes an on-site assessment of the facility. The accreditation is renewed every two years, so this is not a one time cost. This would be an imposed burden with no additional benefit in health and safety.

Discussion of the specific requests of the petitioner follows. The NRC is denying the petitioner's request that the NRC amend its regulations to require that any dosimeter, without exception, that is used to report dose of record and demonstrate compliance with the dose limits specified in the Commission's regulations be processed and evaluated by a dosimetry processor holding accreditation from NVLAP. The NRC does not agree with the petitioner that electronic dosimeters are processed. Although not defined in the regulations, NRC interprets processing to mean a process, separate from, and independent of, the design of the dosimeter, that is required to extract dose information from the dosimeter after exposure to radiation. Processing is necessary with film or thermoluminescent (TLD) dosimetry to obtain the dose information. With film or TLD dosimetry, the quality of the processing is dependent on the competence of the processor, and not on the dosimeter design. Quality is built into the design of dosimeters that do not require processing. Additionally, these devices are calibrated on a routine basis to ensure the device is responding properly. The NRC is not aware of any problem with the current calibration processes, and the petitioner has not provided any evidence of an existing deficiency in the calibration process. The NRC reviews licensees' calibration programs during routine inspections. Subjecting processors to NVLAP accreditation for dosimeters that do not require processing will not improve the reliability of these dosimeters.

Regarding the petitioner's request to remove the exception for NVLAP accreditation for extremity dosimetry, currently allowed in § 20.1501(c), the NRC agrees in principle that it is a good idea to include extremity dosimeters that require processing in the requirement for NVLAP accreditation for processors. However, the ANSI and HPS standard for extremity dosimeters, ANSI/HPS N13.32-1995, “Performance Testing of Extremity Dosimeters,” is undergoing a major revision. The petitioner has provided no evidence that there is a current health and safety problem and much of the industry is voluntarily obtaining NVLAP accreditation for processing of extremity dosimetry. Consequently, the NRC believes it is premature to remove this regulatory exception. Therefore, NRC is not taking regulatory action on this issue.

Granting the petitioner's request to revise the definition of “Individual monitoring device” in § 20.1003 to add “used by licensees to show compliance with § 20.1201” would result in unintended requirements. There are many devices used to show compliance, such as alarming ratemeters, chirpers, and lapel air samplers. The petition, if granted, would result in a requirement that users of essentially all listed types of dosimeters would go through a process that is accredited by NVLAP. Many individual monitoring devices do not require processing to obtain the dose information, such as alarming ratemeters, chirpers, etc., and NVLAP accreditation will not improve the reliability of the devices. The petitioner also proposed adding two more examples, electronic dosimeters and optically stimulated dosimeters, in the definition of “Individual monitoring device.” The current examples in the definition of “Individual monitoring device” are not meant to be all inclusive, and adding two more examples will not add any safety value and does not justify a rulemaking.

This petition must also be evaluated with respect to NRC's backfitting requirements. Backfit is defined, in part, as the modification of, or addition to, the procedures or organization required to design, construct or operate a facility; any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previously applicable staff position (See §§ 50.109, 70.76, 72.62, and 76.76). The NRC requires backfitting only when it determines that there is a substantial increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit, and that the direct and indirect costs of implementation are justified in view of this increased protection.

The petitioner's proposed action would be considered a backfit because it would require licensees to modify their procedures and organization to operate a facility, and the proposed action does not fall within any of the exceptions in the above referenced sections of the regulations. The petition, if granted, would require that any dosimeter that could possibly be used to report the dose of record and demonstrate compliance with the dose limits specified in the NRC regulations be processed and evaluated by a dosimetry processor holding NVLAP accreditation. This would require an expansion of the requirements for the dosimeters with an increased cost and burden to licensees, without a commensurate benefit in health and safety or the common defense and security.

After reviewing the proposed actions, NRC believes that the proposed actions would not pass a detailed backfit analysis. There is insufficient evidence that the petition, if granted, would solve a regulatory problem or improve health and safety. No data were provided by the petitioner, nor did the NRC find any data, to show that existing regulations are inadequate to protect health and safety. The increase in cost to licensees, without a commensurate health and safety benefit or the common defense and security, does not warrant granting this petition.

In conclusion, there is insufficient evidence that the petition solves a regulatory problem or improves health and safety. If the petition were granted, there would be a large increase in burden to licensees that is unjustified without a health and safety concern. Therefore, the NRC has determined that existing NRC regulations are adequate to provide the basis for reasonable assurance that worker health and safety are protected.

For the reasons cited in this document, the NRC denies this petition.

Dated at Rockville, Maryland, this 23 day of December, 2004.

For the Nuclear Regulatory Commission.

Ellis W. Merschoff,

Acting, Executive Director for Operations.