Federal Register Vol. 80, No.85,

Please refer to Docket ID NRC-2014-0044 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2014-0044.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is referenced in the SUPPLEMENTARY INFORMATION section of this document. For the convenience of the reader, the ADAMS accession numbers are also provided in a table in the “Availability of Documents” section of this document.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2014-0044 in the subject line of your comment submission.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

The requirements of appendix I of part 50 of Title 10 of the Code of Federal Regulations (10 CFR) were first published in 1975 (40 FR 19439; May 5, 1975) and are based on the terminology and methodology for dose assessment described in ICRP Publication 2 (1959).1 The requirements of 10 CFR part 50, appendix I, apply to persons who hold NRC licenses to operate nuclear power reactors under 10 CFR part 50 or 10 CFR part 52. Specifically, 10 CFR part 50, appendix I, prescribes the design and performance of equipment used to control radioactive liquid and gaseous effluents to the environment and doses to members of the public from nuclear power plants during normal operations and expected operational occurrences. The 10 CFR part 50, appendix I, regulations provide guidance to licensees for developing technical specifications, as required by 10 CFR 50.36a(a), to keep levels of radioactive materials in effluents released in unrestricted areas “As Low As Is Reasonably Achievable” (ALARA).2

The ALARA requirements for equipment designed to control releases of radioactive materials are contained in various provisions in 10 CFR parts 50 and 52, and the design objectives are contained in 10 CFR part 50, appendix I.3 The dose criteria are based on ICRP Publication 2 dosimetry (i.e., total body and critical organ dose concepts and models). Since its implementation in 1975, the 10 CFR part 50, appendix I, regulations were revised several times, but none of the amendments involved an alignment of the dosimetry basis with that of the NRC's general radiation protection regulations in 10 CFR part 20.

In 1991, the NRC substantively amended its 10 CFR part 20 regulations (56 FR 23360; May 21, 1991). The purpose of the 1991 amendments was to adopt the basic tenets of the ICRP system of radiation dose limitation described in ICRP Publication 26 (1977), “Recommendations of the ICRP.” The 1991 amendments to 10 CFR part 20 were also based upon ICRP Publication 30 (1979-1988), “Limits for Intakes of Radionuclides by Workers,” including its four parts, four supplements and index, which were published during the period of 1979 through 1988. The concern with the current 10 CFR part 50, appendix I, regulations, guidance, and software that supports the guidance is that they are based on dosimetry concepts issued in 1959 under the recommendations of ICRP Publication 2, and as such, no longer align with those used in 10 CFR part 20. In total, the ICRP has updated its terminology and methodology for dose assessments three times since 1959. The most recent terminology and methodology for dose assessments are described in ICRP Publication 103, which was published in 2007.4

In response to the ICRP Publication 103 recommendations, the NRC staff prepared two papers for the Commission's review, SECY-08-0197, “Options to Revise Radiation Protection Regulations and Guidance with Respect to the 2007 Recommendations of the International Commission on Radiological Protection,” dated December 18, 2008 (ADAMS Accession No. ML091310193), and SECY-12-0064, “Recommendations for Policy and Technical Direction to Revise Radiation Protection Regulations and Guidance,” dated April 25, 2012 (ADAMS Accession No. ML121020108). Both papers considered potential revisions to the NRC's regulations in 10 CFR part 20 and 10 CFR part 50, appendix I. The papers are publicly available and described in further detail below.5

The SECY-08-0197 paper described and evaluated the ICRP Publication 103 recommendations along with an NRC staff recommendation that the Commission approve a closer alignment of the NRC regulatory framework with the recommendations of ICRP Publication 103. The NRC staff identified a number of recommendations to achieve this alignment, including (1) the development of a technical basis, or the rationale, for revising radiation protection regulations and (2) outreach with stakeholders and interested parties to identify issues, options, and potential impacts. The NRC staff stated that it would provide the Commission with the results of the stakeholder and interested party interactions, the scope of any proposed rulemaking, regulatory analysis of costs and benefits, evaluation of necessary policy and implementation issues, the resources, and the projected rulemaking completion date, which would be dependent on the ICRP's development of essential technical information. At present, the ICRP is still developing this technical information and it is currently scheduled for publication in 2015.

The Commission made findings and provided direction to the NRC staff in staff requirements memorandum (SRM), SRM-SECY-08-0197, “Options to Revise Radiation Protection Regulations and Guidance with Respect to the 2007 Recommendations of the International Commission on Radiological Protection,” dated April 2, 2009 (ADAMS Accession No. ML090920103). In SRM-SECY-08-0197, the Commission approved the NRC staff's recommendation to “begin engagement with stakeholders and interested parties to initiate development of the technical basis for a possible revision of the NRC's radiation protection regulations, as appropriate and where scientifically justified, to achieve greater alignment with the 2007 recommendations . . . contained in ICRP Publication 103.” The Commission agreed with the NRC staff and the NRC's Advisory Committee on Reactor Safeguards (ACRS) “that the current regulatory framework continues to provide adequate protection of the health and safety of workers, the public, and the environment.” The Commission further stated, “[f]rom a safety regulation perspective, ICRP Publication 103 proposes measures that go beyond what is needed to provide for adequate protection,” and that “[t]his point should be emphasized when engaging stakeholders and interested parties, and thereby focus the discussion on discerning the benefits and burdens associated with revising the radiation protection regulatory framework,” which includes 10 CFR part 50, appendix I.

In response to the Commission's direction in SRM-SECY-08-0197, the NRC staff engaged in extensive stakeholder outreach activities on the broad issues arising from a possible revision of the NRC's radiation protection framework. Three Federal Register notices (FRNs) were issued requesting public feedback and comments (74 FR 32198, July 7, 2009; 75 FR 59160, September 27, 2010; and 76 FR 53847, August 30, 2011). Presentations were made and discussions were held at a variety of professional societies, licensee organizations, public interest groups, and State organizations (e.g., Conference of Radiation Control Program Directors, and Agreement States). In the fall of 2010, the NRC staff conducted a series of facilitated roundtable workshops in Washington, DC, Los Angeles, CA, and Houston, TX. Each workshop included representatives from a broad range of users of radioactive material. This process provided an opportunity for various groups of stakeholders to have a more focused discussion. The October 2010 workshop in Washington, DC, focused on the nuclear power and fuel cycle industries, and the radiation protection programs of other Federal agencies, (e.g., U.S. Department of Energy (DOE), U.S. Environmental Protection Agency (EPA), U.S. Navy, Armed Forces Radiobiology Research Institute, and National Institutes of Health). Some of the participants at the Washington, DC, workshop indicated a general support for an integrated alignment of 10 CFR part 20 and 10 CFR part 50, appendix I, regulations with the recommendations of ICRP Publication 103. Participants also urged a coordinated revision of the NRC's regulations with the requirements of EPA's 40 CFR part 190 because the NRC requires licensees to follow this EPA requirement through the NRC's regulation in 10 CFR 20.1301(e). Finally, some participants noted a concern as to the justification for any revision of 10 CFR part 50, appendix I, as it is not a safety standard and speculated that such a revision would be costly to the industry. Transcripts of each workshop and all written comments received in response to the FRNs are publicly available through the NRC's public Web site on the page entitled, “Options to Revise Radiation Protection Regulations and Guidance,” http://www.nrc.gov/about-nrc/regulatory/rulemaking/potential-rulemaking/opt-revise.html.

In addition to the national outreach described above, the NRC's staff participated in international outreach activities in response to the Commission's direction in SRM-SECY-08-0197. The NRC staff's activities during this time included participation in the revision of the International Basic Safety Standards by the International Atomic Energy Agency (IAEA), from 2009 through its completion in the second quarter of 2013, and observation of the revision of the Euratom Basic Safety Standards Directive in the European Union. The IAEA's and Euratom's revisions focused on aligning their requirements with the recommendations of ICRP Publication 103.

In SECY-12-0064, the NRC staff recommended amending the NRC's regulatory framework, including 10 CFR part 50, appendix I, to better align with those ICRP Publication 103 recommendations concerning terminology and dose calculation methodologies for estimating radiation exposure and risk. The NRC staff cautioned, however, that the NRC should not initiate a rulemaking to better align with these ICRP Publication 103 recommendations until the ICRP publishes its updated dose coefficients and other supporting information, thereby allowing the NRC to engage in a single rulemaking effort. The NRC staff also recommended that it continue to engage in stakeholder outreach.

In SRM-SECY-12-0064, “Recommendations for Policy and Technical Direction to Revise Radiation Protection Regulations and Guidance,” dated December 17, 2012 (ADAMS Accession No. ML12352A133), the Commission directed the NRC staff to develop a regulatory basis for proposed revisions to 10 CFR part 20 and to 10 CFR part 50, appendix I, in parallel, for the purpose of aligning each with the most recent methodology and terminology for dose assessment (namely, the ICRP Publication 103 recommendations). With respect to potential changes to the 10 CFR part 20 regulations, the NRC issued an ANPR on July 25, 2014 (79 FR 43284).6 The potential changes to the 10 CFR part 50, appendix I, regulations under consideration also involve a closer alignment of these regulations with the recommendations in ICRP Publication 103 concerning terminology and dose calculation methodologies for estimating radiation exposure and risk due to effluent releases. The NRC staff will coordinate the development of both regulatory bases together, including consideration of public comments (some of which have already been received) that raise matters common to both sets of regulations. If rulemaking is eventually promulgated, this approach would help ensure that the requirements of 10 CFR part 20 and 10 CFR part 50, appendix I, regulations would be based on a common dosimetry basis, terminology, and dose calculation methodology. A closer alignment of 10 CFR part 50, appendix I, with ICRP Publication 103 would also modernize the NRC's design objectives, regulatory guidance, and supporting computer software.

The EPA is also examining possible revisions to the “Environmental Radiation Protection Standards for Nuclear Power Operations,” 40 CFR part 190, which applies to the entire nuclear fuel cycle.7

Section II of 10 CFR part 50, appendix I, assigns design objectives for doses due to liquid and gaseous effluents. Under Section II.A of appendix I, the annual design objectives for liquid effluents from all pathways of exposure are 0.03 milliSievert (mSv) (3 millirem (mrem)) to the total body and 0.1 mSv (10 mrem) to any organ. Under Section II.B, the annual design objectives for noble gases in gaseous effluents are 0.1 milliGray (mGy) (10 millirad (mrad)) gamma-air dose and 0.2 mGy (20 mrad) beta-air dose, with provisions for increasing or decreasing the design objectives based on total body dose and skin dose. Under Section II.C of appendix I, the annual design objective for radioactive iodines and particulates in gaseous effluents is 0.15 mSv (15 mrem) to any organ.

These design objectives are referenced to the total body and various organs of the human body in accordance with the 1959 recommendations of ICRP Publication 2. ICRP Publication 103 has a larger list of organs and suggests effective dose may be a good indicator of health risk for very low exposures, like those normally encountered with radioactive effluents from nuclear power plants. The design objectives apply to each reactor unit and to radioactive releases to unrestricted areas.

Section II.D of 10 CFR part 50, appendix I, concerns the use of cost-benefit ratios, to ensure facilities use radwaste treatment technology that can reduce the dose to the population within 50 miles of the reactor. The cost-benefit criteria are $1,000 per total body man-rem and $1,000 per man-thyroid-rem. The design objectives and cost benefit criteria may need to be revised to better align 10 CFR part 50, appendix I, with the recommendations of ICRP Publication 103. For example, the dose calculation methodologies in 10 CFR part 50, appendix I (based on ICRP Publication 2), result in a total body dose, while the dose calculation methodologies in ICRP Publication 103 result in an effective dose. Although both calculation methodologies result in an estimate of the dose to an individual, different assumptions are used in each calculation. As a result, the estimated doses to the individual will be different, but the differences are not expected to be significant with respect to radiological protection for members of the public. A more exact estimate of the differences in dose estimates between the two calculation methodologies will be available once all of the dose coefficients for ICRP Publication 103 are published, which is currently scheduled for 2015. A summary of the differences in the dose estimates between ICRP Publication 2 and ICRP Publication 103 methodologies is expected to be included in the regulatory basis document.

Some of the design objectives in 10 CFR part 50, appendix I, are stated in terms of organ dose. The ICRP Publication 103 indicates that the primary use of effective dose is for demonstrating compliance with dose limits. As a result, the NRC is interested in public comments on whether the concept of the organ dose, used in 10 CFR part 50, appendix I, design objectives, should be replaced with effective dose. The ICRP Publication 103 indicates the effective dose is particularly suited to cases where the estimated doses are much less than the annual limit for a member of the public (i.e., 0.1 mSv or 100 mrem per 10 CFR 20.1301). Additionally, if the organ dose design objectives were to be eliminated, the NRC is interested in public comments on what new values may be assigned to the effective dose values that would replace the organ doses.

In addition, 10 CFR part 50, appendix I, includes additional design objectives in Docket RM-50-2, “Concluding Statement of Position of the Regulatory Staff, Guides on Design Objectives for Light-Water-Cooled Nuclear Power Reactors” (February 20, 1974, pp. 25-30).8 For liquid or gaseous effluents, considering all release pathways, the design objective for the site is an annual dose to the total body or to any organ of an individual in an unrestricted area not to exceed 0.05 mSv (5 mrem). For gaseous effluents, as radioactive iodines and particulates in consideration of all release pathways, the design objective for the site is an annual dose to any organ of an individual in an unrestricted area not to exceed 0.15 mSv (15 mrem). The design objective for radioactivity in liquid effluents, excluding tritium and dissolved gases, is a calculated annual quantity not to exceed 5 Curies (Ci) (185 gigaBequerel (GBq)) per reactor unit. Additionally, the design objective for I-131 in gaseous effluents is a calculated annual quantity not to exceed 1 Ci (37 GBq) per reactor unit. The annual design objective for radioactive material above background in gaseous effluents is a calculated quantity not to exceed 0.1 mGy (10 mrad) gamma-air dose and 0.2 mGy (20 mrad) beta-air dose, with provisions for increasing or decreasing the design objectives based on total body dose and skin dose. The Docket RM-50-2 objectives and dose limits are applicable to reactor construction permit applications that were docketed on or after January 2, 1971, and prior to June 4, 1976. As a result, compliance with the Docket RM-50-2 criteria would relieve such applicants from the other cost-benefit provisions of Section II.D of 10 CFR part 50, appendix I.

The dose calculation methodology used to demonstrate compliance with the 10 CFR part 50, appendix I, design objectives is different than the dose methodology used for compliance with 10 CFR part 20. There are multiple methods of calculating dose. In 10 CFR part 20, dose is expressed as total effective dose equivalent (TEDE), which incorporates a risk-based dose, weighted by tissues or organs, as outlined in ICRP Publication 26. Under this TEDE approach, the dose to the body is expressed in a single value. By contrast, 10 CFR part 50, appendix I, uses the recommendations of ICRP Publication 2 to express separate doses for the total body and critical organs. Other differences between 10 CFR part 20 dose constructs and 10 CFR part 50, appendix I, dose constructs exist, such as the use of non-stochastic effects in limiting doses to specific organs in 10 CFR part 20. The ICRP Publication 2 approach used in 10 CFR part 50, appendix I, does not make such distinctions among organs.

The differences between the various dose calculation methodologies used in the NRC's current regulatory framework (i.e., 10 CFR part 20 and 10 CFR part 50, appendix I) and those recommended by the ICRP after ICRP Publication 30,9 have created challenges for the NRC and its licensees. The NRC staff described these challenges in its paper to the Commission, SECY-01-0148, “Processes for Revision of 10 CFR part 20 Regarding Adoption of ICRP Recommendations on Occupational Dose Limits and Dosimetric Models and Parameters,” dated August 2, 2001 (ADAMS Accession No. ML011580363). Specifically, the challenges included licensees' requests to use dosimetry methods based upon the recommendations in the various ICRP publications issued after ICRP Publication 30 for both external (to the body) and internal (within the body) dose assessments; areas of non-alignment between the NRC and international regulatory bodies, including the differences in occupational exposure limits; and the use by some Federal agencies (e.g., DOE and EPA), of dosimetry models based upon ICRP recommendations that were either not incorporated in the NRC's 1991 10 CFR part 20 rulemaking or were published after that rulemaking. The reader is encouraged to review the parallel ANPR on the potential revisions to 10 CFR part 20 for more details related to SECY-01-0148.10

The 10 CFR part 50, appendix I, design objectives for plant systems are more restrictive than either the 1 mSv (100 mrem) per year dose limit for members of the public in 10 CFR 20.1301(a), or the effluent concentration limits (ECLs) in 10 CFR part 20, appendix B, Table 2, “Effluent Concentrations,” which correspond to 0.5 mSv (50 mrem) per year.11 As stated in 10 CFR 50.34a(a), the design objectives of 10 CFR part 50, appendix I, are not radiation protection standards, but are design criteria to ensure equipment designs maintain radioactive effluents ALARA. The NRC's regulation in 10 CFR 50.36a(b), which is referenced in Section IV of 10 CFR part 50, appendix I, invokes compatibility in balancing the need for operational flexibility while still ensuring public health and safety. Releases of radioactive effluents from nuclear power plants are controlled by plant specific technical specifications to ensure that such releases are maintained: (1) ALARA using 10 CFR part 50, appendix I, design objectives and requirements; (2) a small fraction of the 10 CFR 20.1301 public dose limit; and (3) within the EPA's 40 CFR part 190 environmental dose standards for facilities that are part of the uranium fuel cycle,12 as required by 10 CFR 20.1301(e).13 As a result, the 10 CFR 20.1301 public dose limit of 1 mSv (100 mrem) per year on radioactive effluents is rarely controlling in limiting radioactive releases from nuclear power plants as effluents typically are only a fraction of such dose limit or of the 10 CFR part 20, appendix B, Table 2 concentration limits.

Inasmuch as the regulatory purpose of 10 CFR part 20 is not the same as 10 CFR part 50, appendix I, the difference in dosimetry concepts between 10 CFR part 20 (based on ICRP Publication 26) and 10 CFR part 50, appendix I (based on ICRP Publication 2), does not preclude the NRC from having an effective regulatory framework. However, there are practical considerations, as discussed in SECY-08-0197, Enclosure 3, “Details of Technical Options for Revision of 10 CFR part 50 and Appendix I Regulations and Regulatory Guidance for Light Water-Cooled Nuclear Power Reactors,” that the NRC should evaluate when determining whether to transition to a common dosimetry concept for both 10 CFR part 20 and 10 CFR part 50, appendix I, regulations, guidance, and supporting computer software. Enclosure 4, “Listing of NRC Guidance Potentially Subject for Update,” of SECY-08-0197 lists NRC documents and computer codes that would need to be reviewed and updated.

In implementing the ALARA requirements of 10 CFR part 50, appendix I, the NRC published a series of regulatory guides to provide guidance on how to demonstrate compliance with 10 CFR part 50, appendix I. The regulatory guides address methods for estimating the activity released in gaseous and liquid effluents, dispersion of effluents in the atmosphere and water bodies, and calculating potential radiation doses to offsite members of the public (see Section VIII of this ANPR for the full title and availability of documents cited within this ANPR). The key guidance document is Regulatory Guide (RG) 1.109, “Calculation of Annual Doses to Man from Routine Releases of Reactor Effluents for the Purpose of Evaluating Compliance with 10 CFR part 50, Appendix I, Rev. 1,” which describes mathematical models and assumptions for estimating radiation doses to members of the public from radioactive effluents. Two separate guidance documents, NUREG/CR-4013, “LADTAP II-Technical Reference and Users Guide,” and NUREG/CR-4653, “GASPAR II-Technical Reference and Users Guide,” describe computer models that implement the guidance of RG 1.109 and therefore are acceptable methods in demonstrating compliance with the 10 CFR part 50, appendix I, requirements.

Regulatory Guide 1.109 contains tables of dose factors. As described in SECY-08-0197, a revised set of dose factors are a crucial step to any revision of the NRC's radiation protection framework for radioactive effluents. These dose factors provide a basis for calculating doses and determining design objectives in 10 CFR part 50, appendix I. These dose factors would also provide the basis for revising the limits for radioactive effluents in 10 CFR part 20, appendix B, Table 2, ECLs for a representative member of the public. These ECLs are calculated in one of two ways and contain factors to account for the exposure time, the breathing rate, the dose limit for members of the public, and the various age groups exposed. These dose conversion factors also provide a basis for the 10 CFR part 20, appendix B, Table 3, “Releases to Sewers,” limits, which are calculated on a similar basis as 10 CFR part 20 appendix B, Table 2, but with different assumptions. The tables of dose factors in RG 1.109 should be revised as part of any effort to more closely align the NRC's regulations with ICRP Publication 103 recommendations.

Besides the computer codes, RG 1.109 is supported by a series of related documents, including RG 1.110, “Cost-Benefit Analysis for Radwaste Systems for Light-Water-Cooled Nuclear Power Reactors;” which provides methods to conduct cost-benefit analyses in evaluating the performance of radwaste systems used in light water reactors; RG 1.111, “Methods for Estimating Atmospheric Transport and Dispersion of Gaseous Effluents in Routine Releases from Light-Water-Cooled Reactors;” which describes mathematical models and assumptions for estimating atmospheric transport, dispersion, and deposition of airborne effluents during routine operation; RG 1.112, “Calculation of Releases of Radioactive Materials in Gaseous and Liquid Effluents from Light-Water-Cooled Power Reactors,” which describes methods for calculating radioactive source terms for evaluating radioactive waste treatment systems; RG 1.113, “Estimating Aquatic Dispersion of Effluents from Accidental and Routine Reactor Releases for the Purpose of Implementing Appendix I, Rev. 1,” which provides mathematical models and methods in estimating aquatic dispersion of both routine and accidental releases; and RG 1.21, “Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power, Rev. 2,” which provides guidance on how to measure, evaluate, and report to the NRC, plant-related radioactivity (excluding background radiation) in effluents. These documents should be revised as part of any effort to more closely align the NRC's regulations with ICRP Publication 103 recommendations.

The NRC has issued several NUREGS that support RG 1.109 and 10 CFR part 50, appendix I. For example, NUREG-1301, “Offsite Dose Calculation Manual Guidance: Standard Radiological Effluent Controls for Pressurized Water Reactors,” NUREG-1302, “Offsite Dose Calculation Manual Guidance: Standard Radiological Effluent Controls for Boiling Water Reactors,” NUREG-0543, “Methods for Demonstrating LWR Compliance With the EPA Uranium Fuel Cycle Standard (40 CFR part 190),” and NUREG-0133, “Preparation of Radiological Effluent Technical Specifications for Nuclear Power Plants: A Guidance Manual for Users of Standard Technical Specifications,” present guidance on the format and contents of operational programs. The programs include the Offsite Dose Calculation Manual, the radioactive effluent control program (previously known as Radiological Effluent Technical Specifications or RETS), and the Radiological Environmental Monitoring Program (or REMP).

There are other regulatory guides, although not issued for the purpose of supporting RG 1.109, that are nonetheless linked to implementation of 10 CFR part 50, appendix I. For example, RG 4.15, “Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations to License Termination)—Effluent Streams and the Environment, Rev. 2,” addresses quality assurance for maintaining radiological effluent monitoring programs at or around reactor sites. Enclosure 4 of SECY-08-0197 presents an initial listing of NRC guidance (documents and computer codes) that would be reviewed and updated, as needed, in supporting the implementation of any potential revision to 10 CFR part 50, appendix I.

Even though the NRC's regulations on radioactive effluents are protective of the health and safety of the public, over the past decade there have been discussions with stakeholders about updating the basis of 10 CFR part 50, appendix I, design objectives, the regulatory guidance documents, and the supporting computer software to be consistent with the dose methodology used in 10 CFR part 20. Some of the considerations identified by NRC staff are:

(1) Updating 10 CFR part 50, appendix I, requirements and associated dose calculation methodology, which is based upon the recommendations of ICRP Publication 2 (1959), to reflect current scientific knowledge underlying radiation protection principles, such as those described in ICRP Publication 103 (2007);

(2) Engaging in parallel revisions of 10 CFR part 20 and 10 CFR part 50, appendix I, for better alignment with ICRP Publication 103 terminology and methodology for dose assessments; as well as to ensure that any rulemaking amending 10 CFR part 20 and 10 CFR part 50, appendix I, have a common effective or compliance date;

(3) Updating the radiation protection principles because ICRP Publication 2 recommendations are no longer taught in current health physics university curricula and as a result, the NRC staff and industry need to instruct new employees about the implementation of ICRP Publication 2 in reviewing and preparing reactor license applications that rely upon NRC guidance and dose computer codes (e.g., the computer codes LADTAP and GASPAR which calculate doses for liquid effluents and gaseous effluents, respectively) based upon ICRP Publication 2; and

(4) Whether amending 10 CFR part 50, appendix I, to more closely align with the ICRP Publication 103 recommendations substantially increases the overall protection of the public health and safety, and is cost-justified under a backfit or issue finality analysis, such that a revised 10 CFR part 50, appendix I, should be applied to existing 10 CFR part 50 licensees and to those persons who hold NRC licenses under 10 CFR part 52 (e.g., combined license holders and applicants, a holder of a standard design certification).

Given these concerns, the NRC staff is considering more closely aligning the dose concepts of 10 CFR part 20 and the 10 CFR part 50, appendix I, to the ICRP Publication 103 recommendations.

The NRC staff has identified the following objectives in any potential rulemaking to revise 10 CFR part 50, appendix I:

1. Engage stakeholders in a discussion on ways to improve 10 CFR part 50, appendix I, with particular emphasis on improving the terminology and methodology for dose assessments.

2. Collect stakeholder comments, consider stakeholder input, and evaluate various options to achieve a better alignment between 10 CFR part 50, appendix I, and the most recent terminology and methodology for dose assessments in ICRP Publication 103.

3. Establish a technical basis for exceptions to the recommendations of ICRP Publication 103, to the extent these recommendations are considered by the NRC in a future proposed rulemaking.

4. Prepare and submit a regulatory basis document to the Commission in accordance with the Commission's direction in SRM-SECY-12-0064.

Achieving a closer alignment between 10 CFR part 50, appendix I, and the ICRP Publication 103 recommendations would involve changing the underlying terminology and methodology for dose assessment in 10 CFR part 50, appendix I. This closer alignment, if adopted by the NRC, would pose several challenges for the NRC, including the need to revise guidance documents and implementing procedures, and updating computer codes. Likewise, a closer alignment would require licensees to re-train workers to use a new dose assessment system, revise implementing procedures and programs, and revise record keeping and data reporting practices. Therefore, the NRC is seeking to understand the impacts of more closely aligning 10 CFR part 50, appendix I, and associated guidance with the ICRP Publication 103 recommendations regarding terminology and methodology for dose assessments. The issues and options below are intended to elicit input from the public, the regulated community, and other stakeholders. This information will be used to support the development of a regulatory basis for a potential revision of the 10 CFR part 50, appendix I, regulations and associated guidance.

The ICRP has published four primary sets of radiological protection recommendations, namely, ICRP Publication 2 (1959), ICRP Publication 26 (1977); ICRP Publication 60 (1990), and ICRP Publication 103 (2007). As noted earlier, the 10 CFR part 20 regulations are based on ICRP Publication 26, while the 10 CFR part 50, appendix I, requirements are based on ICRP Publication 2. One important way the dose terminology used in 10 CFR part 20 deviates from the ICRP Publication 26 recommendations is by the use of the term “Total Effective Dose Equivalent.” This term was created by the NRC to describe the summation of internal and external exposure. The ICRP Publication 26 recommendations use the phrase “the sum of the dose-equivalent from external exposure” and “the committed effective dose equivalent from the intake of radionuclides.” The ICRP Publication 60 recommendations changed the way tissue and radiation weighting factors were defined and used. There was also a corresponding change in the terminology from quality factors to radiation weighting factors. The ICRP Publication 60 introduced the terms “Effective Dose” (ED) and “Total Effective Dose” (TED) to clearly represent the summation of the dose contributions from external exposure and the intake of radioactive material.

The ICRP Publication 103 recommendations retained the terminology of effective dose and equivalent dose but made several revisions to the calculation of dose, including: (1) The modification of the modeling used for calculation of radiation exposures; (2) changes in tissue weighting factors and radiation weighting factors; and (3) modifications of the metabolic models used to represent the movement of radioactive material through the human body, by use of computer models. These revisions have resulted in the development of reference computational phantoms that are specific models for adult males and females, 15-year-old males and females, and for various other age groups, including infants and 1-year-old, 5-year-old, and 10-year-old children. The reference phantoms for the human body are described in general terms in ICRP Publication 103 and more specifically in ICRP Publication 110 (2009).14

The availability of new models for different age groups provides the opportunity to calculate the numeric values for public exposure to effluents in a more comprehensive manner as compared to the previous calculation methodology of basing assessments primarily on an adult member of the public. As part of the potential rulemaking to amend 10 CFR part 20, the NRC is considering the use of an age and gender weighted dose coefficient and revising the definition of the term “reference man” 15 to be used in environmental dose calculations. With respect to the implementation of 10 CFR part 50, appendix I, RG 1.109 considers four age groups: Infant, child, teenager, and adults. The development of age-specific dose coefficients per unit intake of radioactivity (inhaled or ingested) is described in NUREG-0172, “Age-Specific Radiation Dose Commitment Factors for a One-Year Intake.” As part of this ANPR, the NRC is considering the use of an age and gender averaged approach in any revision to the 10 CFR part 20 and 10 CFR part 50, appendix I.

The NRC staff, as part of its development of the regulatory basis, will consider revising the regulations in 10 CFR part 20 and 10 CFR part 50, appendix I, as well as making conforming changes to other NRC regulations to incorporate the ICRP Publication 103 terms, equivalent dose, effective dose, and “Total Effective Dose.” The NRC staff recognizes the preference, from a regulatory stability standpoint, for retaining TEDE but will analyze, in the regulatory basis, the advantages and disadvantages of replacing TEDE with TED in the NRC regulations. The reader is encouraged to review the parallel ANPR (Docket ID NRC-2009-0279, 79 FR 43284) on the proposed revision to 10 CFR part 20 for more details.

The following options and questions are intended to elicit information and initiate a dialog with the public, the regulated community, and other stakeholders in future workshops and meetings.

Option 1a: Do not change the basis of 10 CFR part 50, appendix I, and continue to use the existing requirements and NRC guidance. This option is based on current NRC regulations continuing to adequately protect the public, although 10 CFR part 20 and 10 CFR part 50, appendix I, are based on different methods of assessing dose. Licensee compliance with 10 CFR part 50, appendix I, will continue to demonstrate that radioactive effluents to unrestricted areas are ALARA. If the NRC selects this option, the NRC may make minor revisions to update supporting NRC guidance, as most of such guidance was published in the late 1970s.

Option 1b: Revise the terminology and methodology for dose assessments in 10 CFR part 50, appendix I, to more closely align with the recommendations of ICRP Publication 103, in parallel with any revisions made to the 10 CFR part 20 regulations.16 This approach would ensure a consistent application of regulatory criteria between 10 CFR part 20 and 10 CFR part 50, appendix I. This option would offer the opportunity to use to a common regulatory basis for calculating and reporting doses.

Question 1-1: What are the advantages and disadvantages of the NRC selecting option 1a?

The following questions are based upon the NRC selecting option 1b:

Question 1-2: What are the advantages and disadvantages of more closely aligning the 10 CFR part 50, appendix I, terminology and methodology for dose assessments with those of the ICRP Publication 103 recommendations?

Question 1-3: At this time, the NRC is contemplating a parallel rulemaking effort, one for 10 CFR part 20 and one for 10 CFR part 50, appendix I, with a common effective or compliance date for both rules. What are the advantages or disadvantages of the NRC conducting such a parallel rulemaking effort?

Question 1-4: What are the backfitting implications of applying option 1b to 10 CFR part 50 licensees? What are the issue finality implications of applying option 1b to those persons who hold NRC approvals under 10 CFR part 52 (e.g., combined license holders and applicants, a holder of a standard design certification)?

Question 1-5: What cost savings would be realized over the life of the operational programs if dose calculation methods (for 10 CFR part 20 and 10 CFR part 50, appendix I) are standardized?

Question 1-6: What operational impacts and costs (per reactor unit) would be incurred by licensees (e.g., in updating licensee programs, procedures, computer codes, training)?

Question 1-7: Would licensee costs and the operational impacts of complying with a revised 10 CFR part 50, appendix I, be similar for both BWRs and PWRs?

Question 1-8: Should all of the conforming changes to the dose based criteria in 10 CFR part 50 (e.g., the TEDE criteria in 10 CFR 50.34(a)(1)(ii), 10 CFR 50.67, and appendix A, “General Design Criteria for Nuclear Power Plants,” Criterion 19, “Control Room”) be changed coincident with the changes to 10 CFR part 50, appendix I, or should conforming changes to other parts of the regulations be conducted in a separate, later rulemaking?

Question 1-9: Should the NRC expand the number of age groups from 4 to 6 as recommended in ICRP Publication 103?

In the event of a revision of the 10 CFR part 50, appendix I, regulations, the NRC would need to consider making revisions to several guidance documents associated with the 10 CFR part 50, appendix I, regulations. In Enclosure 3 of SECY-08-0197, the NRC staff examined a tiered approach reflecting increasing levels of complexity of a revision to the associated guidance documents. The discussion in SECY-08-0197 considered three options for revising those guidance documents associated with 10 CFR part 50, appendix I. The NRC staff notes that the primary guidance document, RG 1.109, has not been updated since 1977.

The following options and questions are intended to elicit information and initiate a dialog with the public, the regulated community, and other stakeholders in future workshops and meetings.

Option 2a: Limited Scope Revision (no changes to the numerical values)—Under this option, the proposed revision would include very limited changes to 10 CFR part 50, appendix I (e.g., to change the design objectives for total body dose only), and would involve very limited changes to only one regulatory guide (e.g., the dose coefficients in R.G. 1.109, Table B-1, “Dose Factors for Exposure to a Semi-Infinite Cloud of Noble Gases,” and Tables E-6, “External Dose Factors for Standing on Contaminated Ground,” to E-14, “Ingestion Dose Factors for Infant,” only).

Option 2b: Full Scope Revision—Under this option, the NRC would consider a complete revision to 10 CFR part 50, appendix I, and all NRC guidance documents, which would include a total of more than 30 regulatory guides, NUREGs, generic communications, and associated software programs. A full scope revision also involves evaluating new radwaste systems, updating dispersion models, new source terms, rewriting RG 1.109, RG 1.110, RG 1.111, and RG 1.112.

Option 2c: Expanded Scope Revision—Under this option, the NRC would include more substantive changes to the regulations and applicable guidance documents than included in Option 2a and potentially substantially less than that listed in Option 2b.

Question 2-1: Which Option (i.e., what scope of changes to NRC guidance documents) seems most appropriate, and are other options available?

Question 2-2: What are the advantages and disadvantages of each of the three options?

The questions in this section explore some of the specific technical details that may be associated with revising the design objectives. The NRC staff has identified the following options for potential revisions to the 10 CFR part 50, appendix I. It should be noted that the various options below are not considered to be mutually exclusive; that is, the NRC may consider one or more of these options, or various combinations of these options:

Option 3a: Maintain the numerical values of the 10 CFR part 50, appendix I, design objectives—the NRC staff would keep the numerical values for design objectives, but change the units. For example, the annual design objective for liquid effluents, which is currently a total body dose of 3 mrem on an annual basis, would be changed to an effective dose of 3 mrem.

Option 3b: Eliminate the use of organ dose as design objectives in 10 CFR part 50, appendix I, for liquid and gaseous effluents—the NRC staff would provide a single effective dose based criterion in lieu of specific organ dose criteria (e.g. thyroid).

Option 3c: Eliminate the use of annual gamma and beta-air doses for gaseous effluents—the NRC staff would eliminate annual gamma-air and beta-air doses for gaseous effluents or convert them to an effective dose.

Option 3d: Update cost-benefit criteria in Section II.D of 10 CFR part 50, appendix I—the NRC staff would update the constant dollar basis in the cost-benefit criteria in Section II.D of 10 CFR part 50, appendix I.

Option 3e: Disposition of Docket RM-50-2, “Guides on Design Objectives for Light-Water-Cooled Nuclear Power Reactors,” in the “Concluding Statement of Position of the Regulatory Staff,” pp. 25-30 (February 20, 1974)—the NRC staff would remove Docket RM-50-2 from 10 CFR part 50, appendix I, Section V, if the NRC staff determines that it is no longer applicable to any pending applications.

The following options for potential revisions to 10 CFR part 50, appendix I, are unrelated to the alignment with the ICRP Publication 103 terminology and methodology but have some implications for associated NRC guidance.

Option 3f: Light-water-cooled reactor provisions of 10 CFR part 50, appendix I—the NRC staff would expand scope of 10 CFR part 50, appendix I, to include designs other than Light-Water-Cooled Reactors.

Option 3g: Consolidation of NRC licensing guidance implementing 10 CFR part 50, appendix I—the NRC staff would consolidate some NRC guidance documents, if appropriate, and update the following RGs and NUREGs:

The following questions are intended to elicit information and initiate a dialog with the public, the regulated community, and other stakeholders in future workshops and meetings.

Question 3-1: Should the NRC focus on only those changes necessary to align 10 CFR part 50, appendix I, with ICRP Publication 103 dose calculation methods (e.g., Issue 3, options 3a thru 3e) or should all of the specific changes identified in options 3a thru 3g be evaluated?

Question 3-2: What significant impacts would be expected if 10 CFR part 50, appendix I, were revised to include all of the options (Issue 3, options 3a thru 3g)?

Question 3-3: Given the scope of the regulatory and technical issues associated with making all of the specific changes identified in Issue 3, options 3a thru 3g, is there any merit in addressing selected options in future implementation phases of this rulemaking (or in separate rulemaking efforts)? If so, which of the options should be delayed?

Question 3-4: Should licensees still report doses separately for organs, such as skin and thyroid, whenever airborne effluent releases are dominated by radioactive iodines and noble gases?

Question 3-5: Should licensees continue to report skin doses, skin dose rates, total body dose rates, and organ doses (including thyroid doses) if organ doses are eliminated? Why or why not?

Question 3-6: Should the categories of releases described in 10 CFR part 50, appendix I (liquid activity, noble gases in gaseous releases, radioactive iodines, tritium, other nuclides in gaseous releases), be expanded or otherwise revised?

The current 10 CFR part 20 radiation protection regulations were promulgated approximately 1 year prior to the publication of the NRC's metrication policy (57 FR 46202; October 7, 1992). The metrication policy addresses the units to be used to express radioactivity, radiation exposure and dose. Therefore, regulations referencing dose limits and other measurements are formatted with the SI units in parentheses. Other NRC regulations have instances in which the SI units are listed first, with the traditional or “English” units in parentheses. Numerical values listed in the 10 CFR part 20 appendices are given only in the traditional units. In SRM-SECY-12-0064, the Commission disapproved the elimination of traditional units or “English” dose units from the NRC's regulations. The SRM further stated that both the traditional and SI units should be maintained.

Pursuant to the NRC's 1992 metrication policy, the NRC supports and encourages the use of the metric system of measurement by the nuclear industry. The 1992 policy directed that the NRC, beginning in 1993, publish the following documents in dual units, with the SI units listed first followed by the English units in parentheses: New regulations, major amendments to existing regulations, regulatory guides, NUREG-series documents, policy statements, information notices, generic letters, bulletins, and all written communications directed to the public. The NRC's policy further directs that NRC documents specific to a licensee, such as inspection reports and docketed material concerning a particular licensee, will be in the system of units employed by the licensee. Furthermore, all event reporting and emergency response communications between licensees, the NRC, and State and local authorities will use the traditional system of measurement. In a 1996 review of its 1992 metrication policy, the Commission stated that it does not intend to revisit the 1992 policy unless it is shown to cause an undue burden or hardship (61 FR 31169-31171; June 19, 1996).

The NRC has issued an ANPR concerning a potential revision to its radiation protection regulations in 10 CFR part 20. In its 10 CFR part 20 ANPR, the NRC staff is seeking input on how the Commission's metrication policy should be implemented, particularly with how the numerical values should be presented in appendix B of 10 CFR part 20. Appendix B of 10 CFR part 20 is set forth in a tabular format with nine columns providing each radionuclide's annual limits on intake (ALI) and derived air concentrations (DAC), effluent concentration limits for airborne and liquid releases to the general environment, and concentration limits for discharges to sanitary sewer systems in the traditional units of microcuries (µCi) or microcuries per milliliter (µCi/ml).

The concerns identified in the 10 CFR part 20 ANPR, such as the use of dual units (SI and traditional) are also relevant to the guidance used in implementing 10 CFR part 50, appendix I. For example, RG 1.109, presents traditional units of radioactivity, dose coefficients, and dose conversion factors, specifically in Table A-1, “Bioaccumulation Factors to Be Used in the Absence of Site-Specific Data;” Table B-1, “Dose Factors for Exposure to a Semi-Infinite Cloud of Noble Gases;” Table E-6, “External Dose Factors for Standing on Contaminated Ground;” Tables E-7 to E-10, “Inhalation Dose Factors;” and Tables E-11 to E-14, “Ingestion Dose Factors.” As noted in the 10 CFR part 20 ANPR, the conversion of the unit of radioactivity from the traditional unit of µCi to the SI unit of becquerel (Bq) is not a whole number or an integer value. As a result, the number of significant digits will result in different values, with the difference determined by the rounding of the numerical values. For example, if rounded to one significant digit, using the standard rounding conventions, the value in SI unit would be smaller than the value in µCi, and would be more restrictive. Therefore, the NRC staff is seeking to explore the implications of presenting dose coefficients, dose conversions factors, and cost-benefit ratios in both SI and traditional units. Licensees are encouraged to review the technical and metrication policy issues described in the 10 CFR part 20 ANPR, as they are not repeated here for brevity.

If 10 CFR part 20 and appendix B to 10 CFR part 20 were revised to include both SI and traditional units, then it would be necessary for consistency to also revise the numerical guides of Section II of 10 CFR part 50, appendix I, and guidance used to implement these requirements. Therefore, providing both sets of units may be perceived as resulting in a cumbersome set of regulatory criteria and tabulations in RG 1.109. Similarly, parallel revisions would need to be made to computer codes used to calculate doses such that dose results would be expressed in both units. One alternative could be to provide an expanded set of tables in the regulatory guide or a NUREG for the convenience of users. The use of traditional and SI units pose significant communication challenges given the potential for confusion when different sets of units are used. The NRC staff is interested in views of possible alternatives, and implications of alternatives on the format of regulations and guidance and impacts on plant operations in aligning any revisions to 10 CFR part 20 and 10 CFR part 50, appendix I, with the Commission's metrication policy.

The following questions are intended to elicit information and initiate a dialog with the public, the regulated community, and other stakeholders in future workshops and meetings.

Question 4-1: Should the annual radioactive effluent release reports contain both metric and English units (e.g., metric units first, followed by English units in parentheses)? Would this be an undue burden or hardship, as identified in the Commission's 1996 review of the 1992 metrication policy (61 FR 31171; June 19, 1996)? Explain and provide examples.

Question 4-2: What costs or other impacts to operational programs would be incurred if metrication was changed as described above?

Question 4-3: Should the requirements of 10 CFR 20.2101(a) and the guidance of RGs 1.21 and 4.15 be revised and integrated with those in 10 CFR part 50, appendix I, thereby allowing licensees to provide records and reports in SI units only?

The NRC plans to conduct public meetings and participate in industry workshops and conferences for the purpose of discussing the issues identified in this ANPR. The public meetings will provide forums for the NRC staff to discuss the issues and questions identified in this ANPR with external stakeholders and to receive information to support development of a regulatory basis for a potential revision to 10 CFR part 50, appendix I. The meetings are not intended to be a formal solicitation of comments, but rather to encourage stakeholders to provide feedback in written form during the ANPR comment period. The NRC will post public meeting announcements at least 10 calendar days before the date of the meetings at http://www.nrc.gov/public-involve/public-meetings/index.cfm. Stakeholders should monitor this NRC public meeting Web site for information about the meetings and issues specific to the potential revision of 10 CFR part 50, appendix I, regulations and guidance.

The NRC has implemented a program to address the possible “Cumulative Effects of Regulation” (CER) in the development of regulatory bases for rulemakings. The CER recognizes the challenges that licensees or other impacted entities (such as Agreement States) may face while implementing new NRC or other agency regulatory requirements. The CER is an organizational effectiveness challenge that results from a licensee or other impacted entity implementing a number of complex positions, programs or requirements within a prescribed implementation period and with limited available resources, including the ability to access technical expertise to address a specific issue. The NRC is specifically requesting comments on the cumulative effects that may result from potential amendments to 10 CFR part 50, appendix I, and revisions to associated guidance documents. When developing comments on the possible cumulative effects of any future rulemaking to amend the 10 CFR part 50, appendix I, and associated guidance documents, please consider the following questions:

Question 5-1: If the NRC conducts a parallel rulemaking effort (amending its regulations in both 10 CFR part 20 and 10 CFR part 50, appendix I), should there be a separate, later compliance date (i.e., a period of time between the rules' effective date and a date when licensees must be in compliance with the rules)? If so, when should the compliance date be set, e.g., 1 year after the effective date? Two years? Another length of time? Please explain the rationale or justification for any such compliance date.

Question 5-2: What actions could be taken to reduce or minimize the implementation time?

Question 5-3: What other requirements, regulations, or orders, whether issued or promulgated by the NRC or another Federal agency, may compete with, or take priority over implementing any potential changes to 10 CFR part 50, appendix I? If so, what are the consequences, including associated costs, and how should they be addressed?

Question 5-4: If 10 CFR part 50, appendix I, is amended, what unintended consequences, including associated costs, may arise that would negate the benefits to revising it? What could be done to minimize unintended consequences?

In addition to responding to the questions above, please provide, if available, information on the costs and benefits of any potential revisions to the 10 CFR part 50, appendix I, regulations and associated guidance documents. This information will be used to support any regulatory analysis performed by the NRC.

The Plain Writing Act of 2010, (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883). The NRC requests comments on this ANPR with respect to the clarity and effectiveness of the language used.

The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.

The NRC may post additional materials to the Federal rulemaking Web site at www.regulations.gov, under Docket ID NRC-2014-0044. The Federal rulemaking Web site allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2014-0044), (2) click the “Email Alert” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

The NRC will consider comments received or other information submitted in response to this ANPR in the development of the proposed draft regulatory basis or any other documents developed as a part of any potential revisions to the 10 CFR part 50, appendix I, regulations. The NRC, however, does not intend to provide responses to comments or other information submitted in response to this ANPR. If the NRC develops a regulatory basis sufficient to support a proposed rule, then there will be an opportunity for public comment when the proposed rule is published and the NRC will respond to such comments if and when it publishes a final rule. If the NRC develops draft supporting guidance or proposes revisions to existing guidance documents associated with the 10 CFR part 50, appendix I regulations, then the public, the regulated community, and other stakeholders will have an opportunity to provide comment on the draft guidance. If NRC decides not to pursue a 10 CFR part 50, appendix I rulemaking, as described in this ANPR, the NRC will publish a document in the Federal Register that will generally address public comments and withdraw this ANPR.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-0933; Directorate Identifier 2014-NM-098-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0099, dated April 30, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Fokker Services B.V. Model F.27 Mark 200, 300, 400, 500, 600, and 700 airplanes. The MCAI states:

Required actions also include revising the airplane maintenance program by incorporating fuel airworthiness limitation items and critical design configuration control limitations. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-0933.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

This proposed AD would require revisions to certain operator maintenance documents to include new actions (e.g., inspections) and Critical Design Configuration Control Limitations (CDCCLs). Compliance with these actions and CDCCLs is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (j) of this AD. The request should include a description of changes to the required inspections that will ensure the continued operational safety of the airplane.

We estimate that this proposed AD affects 15 airplanes of U.S. registry.

We estimate the following costs to comply with this proposed AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-0937; Directorate Identifier 2014-NM-024-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

On November 7, 2011, we issued AD 2011-24-05, Amendment 39-16869 (76 FR 73496, November 29, 2011), for certain Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-200 and -300 series airplanes. AD 2011-24-05 requires actions intended to address the unsafe condition on the products listed above.

Since we issued AD 2011-24-05, Amendment 39-16869 (76 FR 73496, November 29, 2011), the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0010R1, dated May 5, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-200 and -300 series airplanes. The MCAI states:

The compliance times vary depending on airplane utilization and configuration. The earliest compliance time for the initial rotating probe inspections is the later of (1) before 10,400 total flight cycles or 67,800 total flight hours, whichever occurs first; and (2) within 24 months or 14,590 flight cycles or 43,790 flight hours, whichever occurs first. The latest compliance time for the initial inspections is the later of (1) before 20,800 total flight cycles or 67,900 total flight hours, whichever occurs first; and (2) within 24 months or 21,180 flight cycles or 63,560 flight hours, whichever occurs first. The compliance times for the repetitive intervals range between 7,800 flight cycles or 50,900 flight hours and 10,700 flight cycles or 35,200 flight hours. The compliance times for the one-time ultrasonic inspection are the latest of (1) 21,000 flight cycles or 60,600 flight hours and within 2,400 flight cycles or 24 months; or the latest of (2) 22,100 flight cycles and 64,400 flight hours, or within 1,300 flight cycles or 24 months.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-0937.

Airbus has issued the following service information.

• Airbus Service Bulletin A330-57-3081, Revision 05, including Appendix 01, dated November 13, 2012.

• Airbus Service Bulletin A330-57-3090, dated June 15, 2011.

• Airbus Service Bulletin A330-57-3098, dated August 30, 2007.

• Airbus Service Bulletin A330-57-3098, Revision 02, June 15, 2011.

• Airbus Service Bulletin A330-57-3098, Revision 03, including Appendix 01, dated September 24, 2014.

• Airbus Service Bulletin A330-57-3117, including Appendix 01, dated January 25, 2013.

• Airbus Service Bulletin A340-57-4089, Revision 05, including Appendix 01, dated November 13, 2012.

• Airbus Service Bulletin A340-57-4098, Revision 01, dated June 15, 2011.

• Airbus Service Bulletin A340-57-4106, dated August 30, 2007.

• Airbus Service Bulletin A340-57-4106, Revision 02, including Appendix 01, dated August 30, 2007.

• Airbus Service Bulletin A340-57-4106, Revision 03, including Appendix 01, dated September 24, 2012.

• Airbus Service Bulletin A340-57-4126, including Appendix 01, dated January 25, 2013.

This service information describes procedures for inspections for cracking of the hole(s) of the horizontal flange of the keel beam, and contacting the manufacturer for repair instructions. Additionally, this service information describes procedures for a one-time ultrasonic inspection for cracking at fastener hole “Nr 6,” and provides optional terminating action for the repetitive inspections.

The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this NPRM.

The compliance time for the modification specified in this proposed AD for addressing widespread fatigue damage (WFD) was established to ensure that discrepant structure is modified before WFD develops in airplanes. Standard inspection techniques cannot be relied on to detect WFD before it becomes a hazard to flight. We will not grant any extensions of the compliance time to complete any AD-mandated service bulletin related to WFD without extensive new data that would substantiate and clearly warrant such an extension.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We estimate that this proposed AD affects 35 airplanes of U.S. registry.

The actions that are required by AD 2011-24-05, Amendment 39-16869 (76 FR 73496, November 29, 2011), and retained in this proposed AD take about 41 work-hours per product, at an average labor rate of $85 per work hour. Required parts cost about $191 per product. Based on these figures, the estimated cost of the actions that are required by AD 2011-24-05 is $3,676 per product.

We also estimate that it would take about 23 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $68,425, or $1,955 per product.

We have received no definitive data that would enable us to provide a cost estimate for the on-condition actions specified in this proposed AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-0934; Directorate Identifier 2014-NM-030-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued Airworthiness Directive 2013-0299, dated December 19, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Dassault Aviation Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-0934.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We estimate that this proposed AD affects 170 airplanes of U.S. registry.

We also estimate that it would take about 4 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $57,800, or $340 per product.

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking (USCG-2015-0248), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via http://www.regulations.gov) or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via http://www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, type the docket number [USCG-2015-0248] in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking.

http://www.regulations.gov, click on the “submit a comment” box, which will then become highlighted in blue. In the “Document Type” drop down menu select “Proposed Rule” and insert “USCG-2015-0248” in the “Keyword” box. Click “Search” then click on the balloon shape in the “Actions” column. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box, insert USCG-2015-0248 and click “Search.” Click the “open Docket Folder” in the “Actions” column.

You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008 issue of the Federal Register (73 FR 3316).

The Coast Guard does not plan to hold a public meeting. But you may submit a request for one by using one of the four methods specified under ADDRESSES. Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register.

Shell Exploration & Production Company has proposed and received permits for drill sites within the Burger prospects, Chukchi Sea, Alaska.

During the 2015 timeframe, Shell Exploration & Production Company has proposed drilling exploration wells at various Chukchi Sea prospects depending on favorable ice conditions, weather, sea state, and any other pertinent factors. Each of these drill sites will be permitted for drilling in 2015 to allow for operational flexibility in the event sea ice conditions prevent access to one of the locations. The number of actual wells that will be drilled will depend on ice conditions and the length of time available for the 2015 drilling season. The predicted “average” drilling season, constrained by prevailing ice conditions and regulatory restrictions, is long enough for two to three typical exploration wells to be drilled.

The actual order of drilling activities will be controlled by an interplay between actual ice conditions immediately prior to a rig move, ice forecasts, any regulatory restrictions with respect to the dates of allowed operating windows, whether the planned drilling activity involves only drilling the shallow non-objective section or penetrating potential hydrocarbon zones, the availability of permitted sites having approved shallow hazards clearance, the anticipated duration of each contemplated drilling activity, the results of preceding wells and Marine Mammal Monitoring and Mitigation plan requirements.

The DRILLSHIP NOBLE DISCOVERER has a “persons on board” capacity of 124, and it is expected to be at capacity for most of its operating period. The DRILLSHIP NOBLE DISCOVERER's personnel will include its crew, as well as Shell employees, third party contractors, Alaska Native Marine Mammal Observers and possibly Bureau of Safety and Environmental Enforcement (BSEE) personnel.

While conducting exploration drilling operations, the DRILLSHIP NOBLE DISCOVERER will be anchored using an anchoring system consisting of an 8-point anchored mooring spread attached to the onboard turret and could have a maximum anchor radius of 3,600 ft (1,100 m). The center point of the DRILLSHIP NOBLE DISCOVERER will be positioned within the prospect location in the Chukchi Sea.

The DRILLSHIP NOBLE DISCOVERER will move into the Chukchi Sea on or about July 1, 2015 and onto a prospect location when ice allows. Drilling will conclude on or before October 31, 2015. The drillship and support vessels will depart the Chukchi Sea at the conclusion of the 2015 drilling season.

Shell Exploration & Production Company made a request that the Coast Guard establish a safety zone around the DRILLSHIP NOBLE DISCOVERER due to safety concerns for both the personnel aboard the DRILLSHIP NOBLE DISCOVERER and the environment. Shell Exploration & Production Company indicated that it is highly likely that any allision or inability to identify, monitor or mitigate any risks or threats, including ice-related hazards that might be encountered, may result in a catastrophic event. Incursions into the areas near the drilling vessels by unapproved vessels could degrade the ability to monitor and mitigate such risks.

In evaluating the request for a safety zone, the Coast Guard explored relevant safety factors and considered several criteria, including but not limited to: (1) The level of shipping activity around the operation; (2) safety concerns for personnel aboard the vessel; (3) concerns for the environment given the sensitivity of the environmental and the importance of fishing and hunting to the indigenous population; (4) the lack of any established shipping fairways, and fueling and supply storage/operations which increase the likelihood that an allision would result in a catastrophic event; (5) the recent and potential future maritime traffic in the vicinity of the proposed areas; (6) the types of vessels navigating in the vicinity of the proposed area; (7) the structural configuration of the vessel, and (8) the need to allow for lawful demonstrations without endangering the safe operation of the vessel.

Results from a thorough and comprehensive examination of the criteria, IMO guidelines, and existing regulations warrant the establishment of the proposed temporary safety zone. The proposed regulation would significantly reduce the threat of allisions that could result in oil spills, and other releases. Furthermore, the proposed regulation would increase the safety of life, property, and the environment in the Chukchi Sea by prohibiting entry into the zone unless specifically authorized by the Commander, Seventeenth Coast Guard District, or a designated representative. Due to the remote location and the need to protect the environment, the Coast Guard may use criminal sanctions to enforce the safety zone as appropriate.

The purpose of the temporary safety zone is to protect the drillship from vessels operating outside the normal shipping channels and fairways. Placing a safety zone around the drillship will significantly reduce the threat of allisions, which could result in oil spills and releases of natural gas, and thereby protects the safety of life, property, and the environment.

For the reasons described above, the Coast Guard is proposing to establish a temporary safety zone around the DRILLSHIP NOBLE DISCOVERER while anchored or deploying and recovering moorings on location in order to drill exploratory wells in various locations in the Chukchi Sea Outer Continental Shelf, Alaska from July 1 to October 31, 2015.

The proposed temporary safety zone would encompass the area that extends 500 meters from the outer edge of the DRILLSHIP NOBLE DISCOVERER, as well as 500 meters from those points, suitably marked by a buoy, where the DRILLSHIP NOBLE DISCOVERER's mooring spread meets the ocean's surface. This safety zone will be in effect both when the DRILLSHIP NOBLE DISCOVERER is anchored and when deploying and recovering moorings. As a result, the size and shape of the safety zone will vary, depending on how far from the vessel the mooring spread is deployed, which is expected to be no more than 1,000 meters. No vessel would be allowed to enter or remain in this proposed safety zone except the following: An attending vessel or a vessel authorized by the Commander, Seventeenth Coast Guard District or a designated representative. They may be contacted on VHF-FM Channel 13 or 16 or by telephone at 907-463-2000.

For any group intending to conduct lawful demonstrations in the vicinity of the rig, these demonstrations must be conducted outside the safety zone.

The Coast Guard developed this proposed rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 14 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

This rule is not a significant regulatory action due to the location of the DRILLSHIP NOBLE DISCOVERER on the Outer Continental Shelf and its distance from both land and safety fairways. Vessels traversing waters near the proposed safety zone will be able to safely travel around the zone without incurring additional costs.

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612), the Coast Guard has considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the Burger Prospects of the Chukchi Sea.

This safety zone will not have a significant economic impact or a substantial number of small entities for the following reasons: This rule will enforce a safety zone around a drilling unit facility that is in areas of the Chukchi Sea not frequented by vessel traffic and is not in close proximity to a safety fairway. Further, vessel traffic can pass safely around the safety zone without incurring additional costs.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LCDR Jason Boyle, Coast Guard Seventeenth District, Office of Prevention; telephone 907-463-2821, [email protected]. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000.00 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This proposed rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

The Coast Guard has analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Coast Guard analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A preliminary environmental analysis checklist supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandants Instruction.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 147 as follows:

On May 20, 2013, HHS published a notice of proposed rulemaking (NPRM) to the regulations at 45 CFR part 98 for the Child Care and Development Fund (CCDF) program at 78 FR 29442. Subsequently, the Child Care and Development Block Grant Act, which governs the CCDF program, was reauthorized in November 2014 (Public Law 113-186). In light of this statutory change, HHS is hereby withdrawing the May 2013 NPRM, and will begin a new regulatory process with a proposed rule based on the new law.

Under the current regulations, a driver with ITDM may not operate a CMV in interstate commerce unless the driver obtains an exemption from FMCSA, which must be renewed at least every 2 years. FMCSA proposes to allow individuals with well-controlled ITDM to drive CMVs in interstate commerce if they are examined at least annually by an ME who is listed in the National Registry of Certified Medical Examiners (National Registry), have received the MEC from the ME, and are otherwise physically qualified. FMCSA believes that this procedure will adequately ensure that drivers with ITDM manage the condition so that it is stable and well-controlled, and that such a regulatory provision creates a clearer, equally effective and more consistent framework than a program based entirely on exemptions under 49 U.S.C. 31315(b).

FMCSA evidence reports, ADA studies, and MRB conclusions and recommendations indicate that drivers with ITDM are as safe as other drivers when their condition is well-controlled. In order to determine if a driver with ITDM meets FMCSA's physical qualification standards and is able to obtain a MEC, the driver must be evaluated at least annually by his or her TC. The evaluation by the TC would ensure that the driver is complying with an appropriate standard of care for individuals with ITDM and would allow the TC to monitor for any of the progressive conditions associated with diabetes (e.g., nerve damage to the extremities, diabetic retinopathy, cataracts and hypoglycemia unawareness). The ME must obtain information from the TC to demonstrate the driver's condition is stable and well-controlled.

FMCSA believes that this rulemaking would not have a significant economic impact. Compared to other CMV drivers, drivers with ITDM will incur costs for an additional Department of Transportation (DOT) medical examination of $151 annually; however, they will have the ability to earn a living without the inconvenience and added costs of obtaining and maintaining an exemption. The increased monitoring of the driver with ITDM could lead to better driver health while ensuring that the physical condition of CMV drivers enables them to operate CMVs safely. The total annual cost of medically qualifying drivers with ITDM would increase in comparison to the cost of the current exemption program based on a projected increase in the population of drivers who would seek medical certification, as shown in Table 1 below for ITDM drivers:

As the Agency lacks data to project the affected population changes in subsequent years, the analysis projects this rule's total annual costs to remain constant in real terms during each of the ten years from the initial compliance date. Therefore, for this rule a separate discussion of the annualized costs at the 7% discount rate is unnecessary, as the annualized costs are identical to the corresponding discounted annual costs.

FMCSA encourages you to participate in this rulemaking by submitting comments and related materials. Where possible, we would like you to provide scientific, peer-reviewed data to support your comments. On March 17, 2006, the Agency published an Advance Notice of Proposed Rulemaking (ANPRM) on the diabetes standard (71 FR 13810). In this NPRM, the Agency does not respond to comments submitted in response to the ANPRM. If you believe your previous comments are relevant to today's proposed rule, please reference them in your new comments to the docket FMCSA-2005-23151.

If you submit a comment, please include the docket number for this rulemaking (FMCSA-2005-23151), indicate the heading of the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online, by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.

To submit your comment online, go to www.regulations.gov, type the docket number, “FMCSA-2005-23151” in the “Keyword” box, and click “Search.” When the new screen appears, click the “Comment Now!” button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party, and click “Submit.” If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.

FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments.

To view comments and any document mentioned in this preamble, go to www.regulations.gov, insert the docket number, “FMCSA-2005-23151” in the “Keyword” box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document listed to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Services in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

FMCSA has authority under 49 U.S.C. 31136(a) and 31502(b)—delegated to the Agency by 49 CFR 1.87(f) and (i), respectively—to establish minimum qualifications, including medical and physical qualifications, for CMV drivers operating in interstate commerce. Section 31136(a)(3) requires that the Agency's safety regulations ensure that the physical conditions of CMV drivers enable them to operate their vehicles safely, and that MEs trained in physical and medical examination standards perform the physical examinations required of such operators.

In 2005, Congress authorized the creation of the Medical Review Board (MRB) composed of experts “in a variety of medical specialties relevant to the driver fitness requirements” to provide advice and recommendations on qualification standards [49 U.S.C. 31149(a)]. The position of Chief Medical Officer was authorized at the same time [49 U.S.C. 31149(b)]. Under section 31149(c)(1), the Agency, with the advice of the MRB and Chief Medical Officer, is directed to “establish, review and revise . . . medical standards for operators of commercial motor vehicles that will ensure that the physical condition of operators of commercial motor vehicles is adequate to enable them to operate the vehicles safely.” As discussed below in this proposed rule, the Agency, in conjunction with the Chief Medical Officer, asked the MRB to review and report on the current diabetes standard. The Board's recommendations and the Agency's responses are described elsewhere in this NPRM.

In addition to the statutory requirements specific to the physical qualifications of CMV drivers [49 U.S.C. 31136(a)(3)], FMCSA's regulations must also ensure that CMVs are maintained, equipped, loaded and operated safely [49 U.S.C. 31136(a)(1)]; that the responsibilities imposed on CMV drivers do not impair their ability to operate the vehicles safely [49 U.S.C. 31136(a)(2)]; that the operation of CMVs does not have a deleterious effect on the physical condition of the drivers [49 U.S.C. 31136(a)(4)]; and that drivers are not coerced by motor carriers, shippers, receivers, or transportation intermediaries to operate a vehicle in violation of a regulation promulgated under 49 U.S.C. 31136 (which is the basis for much of the FMCSRs), 49 U.S.C. chapter 51 (which authorizes the hazardous materials regulations) or 49 U.S.C. chapter 313 (the authority for the Commercial Driver's License (CDL) regulations and the related drug and alcohol testing requirements) [49 U.S.C. 31136(a)(5)].

This proposed rule is based on 49 U.S.C. 31136(a)(3) and 31149(c), but does not deal with 49 U.S.C. 31136(a)(1), (2), or (4). FMCSA believes that coercion of drivers with ITDM to violate the current rule preventing them from operating in interstate commerce—which is prohibited by 49 U.S.C. 31136(a)(5)—does not and will not occur. On the contrary, motor carriers have generally been reluctant to employ such drivers at all. The Federal Highway Administration's (FHWA) original exemption program in the 1990s and FMCSA's subsequent program under 49 U.S.C. 31315(b) allowed selected individuals with ITDM to drive legally for the first time, while also generating data showing that their safety records were at least as good as those of non-ITDM drivers.

Section 4129 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) [Pub. L. 109-59, 119 Stat. 1144, 1742, Aug. 10, 2005], in paragraphs (a) through (c), directed the Agency to relax certain requirements of its exemption program for drivers with ITDM.2 The last paragraph of section 4129 provides that insulin-treated individuals may not be held by the Secretary to a higher standard of physical qualification in order to operate a commercial motor vehicle in interstate commerce than other individuals applying to operate, or operating, a commercial motor vehicle in interstate commerce; except to the extent that limited operating, monitoring, and medical requirements are deemed medically necessary under regulations issued by the Secretary.3

FMCSA believes that this proposed rule would satisfy the purposes of section 4129(d), by imposing appropriate requirements on such drivers as contemplated by that provision and maintaining current levels of highway safety.

Finally, prior to prescribing any regulations, FMCSA must consider their “costs and benefits” [49 U.S.C. 31136(c)(2)(A) and 31502(d)]. Those factors are discussed in the Rulemaking Analyses and Notices section of this NPRM.

Diabetes is a disorder of metabolism—the way the body uses digested food for growth and energy.4 The body breaks down most food into glucose. After digestion, glucose passes into the bloodstream, where cells use it for growth and energy. For glucose to enter cells, insulin, a hormone produced by the pancreas, must be present. Normally, the pancreas produces the right amount of insulin automatically to move glucose from blood into the cells. In people with diabetes, however, either the pancreas produces little or no insulin or the cells do not respond appropriately to the insulin that is produced. Glucose builds up in the blood, overflows into the urine, and passes out of the body in the urine. Thus, the body loses its main source of fuel although the blood contains large amounts of glucose. The excess glucose in the blood (called hyperglycemia) plays an important role in disease-related complications.

Type 1 diabetes is an autoimmune disease in which the immune system attacks and destroys the insulin-producing cells in the pancreas. The pancreas then produces little or no insulin. A person who has Type 1 diabetes must take insulin daily to live. Type 1 diabetes accounts for about 5 percent of all diagnosed cases of diabetes in the United States and is usually diagnosed in children and young adults.

In Type 2 diabetes, the pancreas is usually producing enough insulin, but the body cannot use the insulin effectively, a condition called insulin resistance. After several years, insulin production decreases. The result is the same as for Type 1 diabetes—glucose builds up in the blood and the body cannot make efficient use of its main source of fuel. Type 2 diabetes can be treated through diet, with insulin, or with medications other than insulin. The prevalence of Type 2 diabetes increases with age. Type 2 diabetes accounts for about 95 percent of diagnosed diabetes in adults in the United States.

Over time, people with the disease have a heightened potential of developing other problematic medical conditions. These conditions include proliferative diabetic retinopathy,5 cataracts and glaucoma, high blood pressure and other cardiovascular problems, kidney disease, and circulation issues for the extremities, which can cause numbness and decreased functionality, particularly with feet and legs.

Of particular concern for drivers, however, are the immediate symptoms of severe hypoglycemia—a condition where insulin treatment may cause blood glucose to drop to a dangerously low concentration.6 A person experiencing hypoglycemia may have one or more of the following symptoms: Double vision or blurry vision; shaking or trembling; tiredness or weakness; unclear thinking; fainting; seizures; or coma.7 If any of these symptoms of severe hypoglycemia occurs while someone is driving, there is the potential for a crash.

Some people with blood glucose readings at concentrations below optimal levels perceive no symptoms and no early warning signs of low blood glucose—a condition called hypoglycemia unawareness. This condition occurs most often in people with Type 1 diabetes, but it can occur in people with Type 2 diabetes. Note, however, that impairments associated with diabetes mellitus can be abated through proper disease management and monitoring to stabilize and control the condition.

From 1940 until 1971, one of FMCSA's predecessors recommended that CMV drivers have urine glucose tests as part of medical examinations for determining whether persons are physically qualified to drive CMVs in interstate or foreign commerce (4 FR 2294, June 7, 1939, effective date January 1, 1940). In 1971, FHWA, FMCSA's predecessor agency, established the current standard for drivers with ITDM (35 FR 6458, April 22, 1970, effective date January 1, 1971), which includes testing urine for glucose. That standard states that a “person is physically qualified to drive a commercial motor vehicle if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control.” 49 CFR 391.41(b)(3). However, beginning in 1993, CMV drivers with ITDM had the opportunity to apply to FHWA for a waiver until a 1994 Federal court decision invalidated the waiver program.

In 1998, section 4018 of the Transportation Equity Act for the 21st Century, Public Law 105-178, 112 Stat. 413-4 (TEA-21) (set out as a note to 49 U.S.C. 31305) directed the Secretary to determine the feasibility of developing “a practicable and cost-effective screening, operating and monitoring protocol” for allowing drivers with ITDM to operate CMVs in interstate commerce. This protocol “would ensure a level of safety equal to or greater than that achieved with the current prohibition on individuals with insulin treated diabetes mellitus driving such vehicles.”

As directed by section 4018, FHWA compiled and evaluated the available research and information. It assembled a panel of medical experts in the treatment of diabetes to investigate and report about the issues concerned with the treatment, medical screening, and monitoring of ITDM individuals in the context of operating CMVs. In July 2000, FMCSA 9 submitted a report to Congress titled, “A Report to Congress on the Feasibility of a Program to Qualify Individuals with Insulin Treated Diabetes Mellitus to Operate Commercial Motor Vehicles in Interstate Commerce as Directed by the Transportation Equity Act for the 21st Century” (TEA-21 Report to Congress).10 This Report to Congress concluded that it was feasible to establish a safe and practicable protocol containing three components allowing some drivers with ITDM to operate CMVs. The three components were: (1) Screening of qualified ITDM commercial drivers, (2) establishing operational requirements to ensure proper disease management by such drivers, and (3) monitoring safe driving behavior and proper disease management.

On July 31, 2001, because of the conclusions found in the TEA-21 Report to Congress, FMCSA published a notice proposing to issue exemptions from the FMCSRs allowing drivers with ITDM to operate CMVs in interstate commerce. 66 FR 39548. After receiving and considering comments, FMCSA issued a Notice of Final Disposition (“2003 Notice”) establishing the procedures and protocols for implementing the exemptions for drivers with ITDM. 68 FR 52441 (Sept. 3, 2003). So beginning again in 2003, CMV drivers with ITDM could apply to FMCSA for an exemption from this prohibition.

To obtain an exemption, a CMV driver with ITDM had to meet the specific conditions and comply with the requirements set out in the final disposition. The driver had to follow the application process set out in 49 CFR part 381, subpart C, and FMCSA could not grant an exemption unless a level of safety equivalent to, or greater than, the level achieved without the exemption would be maintained. 49 U.S.C. 31315 and 49 CFR 381.305(a).

In conformity with the conclusions of the TEA-21 Report to Congress, the 2003 Notice implemented the three protocol components recommended in the report, with a few modifications.

FMCSA administers an exemption program for individuals with ITDM who wish to become qualified or maintain their physical qualifications as CMV drivers. The Agency administers this exemption program under 49 CFR part 381 subpart C according to directives in notices of disposition published in 2003 (68 FR 52441, Sept. 3, 2003) and 2005 (70 FR 67777, Nov. 8, 2005).

To apply for an exemption under the current program administered by FMCSA, the driver must submit a letter application with medical documentation showing the following: 11

(1) The driver has been examined by a board-certified or board-eligible endocrinologist who has conducted a comprehensive evaluation including (i) one measure of glycosylated hemoglobin within a range of ≥7 percent and ≤10 percent, and (ii) a signed statement regarding the doctor's determinations;

(2) The driver has obtained a signed statement from an ophthalmologist or optometrist that the driver has been examined, has no unstable proliferative diabetic retinopathy, and meets the vision standard in § 391.41(b)(10); and

(3) The driver has obtained a signed copy of an ME's Medical Evaluation Report and of a Medical Examiner's Certificate issued showing that the driver meets all other standards in § 391.41(b).

FMCSA does not conduct exams of any of the drivers in the exemption program. We accept the paperwork from the MEs and the TCs and make our decision based on the paperwork. To maintain the exemption, the driver must meet certain conditions, which include the following:

(1) Yearly medical re-certification by an ME;

(2) Quarterly reports submitted by an endocrinologist to FMCSA including blood glucose logs, insulin regimen changes and hypoglycemic events, if any, that the driver has experienced;

(3) Annual comprehensive medical evaluation by an endocrinologist;

(4) An annual vision evaluation confirming no evidence of unstable proliferative diabetic retinopathy and meeting the vision standard for CMV drivers;

(5) Maintaining appropriate medical supplies for glucose management, including a monitor, insulin, and an amount of rapidly absorbable glucose in the vehicle to be used as necessary;

(6) Following a protocol to monitor and maintain blood glucose levels; and

(7) Reporting all episodes of severe hypoglycemia, significant complications, or inability to manage diabetes, and any involvement in a crash or adverse event to the Agency.

According to the annual report for the diabetes exemption program, FMCSA received 858 applications in 2012, continuing the growth trend of the preceding six years.12 Before granting a request for an exemption, FMCSA must publish a notice in the Federal Register for each exemption requested, explaining that the request has been filed, and providing the public an opportunity to inspect the safety analysis and any other relevant information known to the Agency and to comment on the request. The notice also must identify the person or class of persons who will receive the exemption, the provisions from which the person will be exempt, the effective period, and all terms and conditions of the exemption. In addition, the Agency must monitor the implementation of each exemption to ensure compliance with its terms and conditions.

After the comment period, as part of the approval process, FMCSA must publish a notice of its decision to approve or deny the request. A driver must reapply for an exemption every 2 years. However, FMCSA may revoke an exemption immediately under standards set out in § 381.330.

Should this proposal become a final rule, CMV drivers with ITDM could meet physical qualification standards under the new rule without applying for or receiving exemptions.

This section of the preamble is divided into two major subsections. The first section discusses data reflected in evidence reports and American Diabetes Association (ADA) studies examining risks associated with diabetes and driving in general, and the association between hypoglycemia and ITDM in particular. It also discusses MRB findings and conclusions based on evidence reports. The second section explains why FMCSA is proposing to eliminate the exemption program and establish a medical qualification standard for drivers with ITDM, including relating the proposed rule elements to the current exemption program, MRB recommendations, and findings from the ADA studies.

FMCSA uses an evidence-based systematic review process and consultation with the MRB and the Chief Medical Officer to revise or develop medical standards and guidelines for commercial drivers. In its deliberations concerning commercial drivers with ITDM, the MRB reviewed the analysis of a 2006 evidence-based report and a 2010 update of that report.13 Both reports focused primarily on the risks to driver safety from the acute risks associated with diabetes mellitus (e.g., hypoglycemia), but did not address driver safety issues related to chronic complications of diabetes (e.g., diabetic nephropathy, neuropathy, retinopathy, and/or cardiovascular conditions resulting from the long-term complications of diabetes). Both the evidence reports and ADA studies, discussed in the next section, show that hypoglycemia is the chief safety concern for drivers with the disease. Further, the 2010 Update studies show use of insulin, a long duration on insulin, and impaired hypoglycemic awareness as among the factors “repeatedly shown to be associated with an increased incidence of severe hypoglycemia.” 14

After considering the findings in the evidence-based reports, the MRB members agreed unanimously that hypoglycemia among individuals with diabetes mellitus is an important risk factor for motor vehicle crashes and approved a set of recommendations to FMCSA for CMV drivers with diabetes mellitus intended to reduce the likelihood of their operating when impaired by hypoglycemic conditions. The MRB recommended that FMCSA allow individuals with ITDM to drive CMVs if they are free of severe hypoglycemic reactions, have no altered mental status or unawareness of hypoglycemia, and manage their diabetes mellitus properly to keep blood sugar levels in the appropriate ranges. The MRB also recommended that all drivers diagnosed with diabetes mellitus be required to obtain at least annual recertification by a ME who is a licensed physician, regardless of whether they are insulin-treated. However, the MRB recommended maintaining a restriction on medical qualification of drivers with ITDM from passenger and hazardous materials transportation.

In a 2012 peer-reviewed position paper titled, “Diabetes and Driving,” the ADA provided “an overview of existing (drivers) licensing rules for people with diabetes, address[ing] the factors that impact driving for this population, and identify[ing] general guidelines for assessing driver fitness and determining appropriate licensing restrictions.” 15 At the end of the paper, ADA set out recommendations for identifying and evaluating diabetes in drivers.16 Although the ADA addressed these issues in discussing fitness for non-CMV drivers with diabetes, the same disease-related conditions that present driving concerns in the non-CMV driving population create those same concerns in the CMV driving population. ADA begins by stating, “[M]ost people with diabetes safely operate motor vehicles without creating any meaningful risk of injury to themselves or others.” 17 Summarizing several studies on understanding diabetes and driving, the paper notes inconsistent findings relative to which drivers with diabetes are at higher risk of crashes. However, the paper notes that according to the studies, “The single most significant factor associated with driving collisions for drivers with diabetes appears to be a recent history of severe hypoglycemia,18 regardless of the type of diabetes or the treatment used.” 19 The paper further references studies finding that even moderate hypoglycemia “significantly and consistently impairs driving safely and judgment as to whether to continue to drive or self-treat under such metabolic conditions.” 20

In evaluating fitness for drivers with diabetes, the ADA paper underscores the importance of individualized assessments “based not solely on diagnosis of diabetes but rather on concrete evidence of actual risk.” 21 According to the ADA paper, such an assessment “must include an assessment by the treating physician or other diabetes specialist who can review recent diabetes history” as these health care providers are “the best source of information concerning the driver's diabetes management and history.” 22 Among other things, the ADA paper recommends physicians provide the following information to licensing authorities: (1) The driver's risk of severe hypoglycemia; (2) the driver's ability to recognize imminent hypoglycemia and take appropriate corrective action; and (3) the driver's ability to provide evidence of sufficient self-monitoring of blood glucose. Appropriate screening inquiries related to driver fitness include “whether the driver has, within the past 12 months, lost consciousness due to hypoglycemia, experienced hypoglycemia that required intervention from another person to treat or that interfered with driving, or experienced hypoglycemia that developed without warning.” 23

The ADA's summary of findings concerning the risks of driving and diabetes concludes that, “[M]ost people with diabetes safely operate motor vehicles without creating any meaningful risk of injury to themselves or others.” 24 This statement also reflects FMCSA's conclusion based on the available evidence.

In accordance with section 4129(d) of SAFETEA-LU referenced earlier in the Legal Basis section of the preamble, FMCSA may not adopt higher physical qualification standards for drivers with ITDM “except to the extent that limited operating, monitoring, and medical requirements are deemed medically necessary.” As noted above, CMV drivers with diabetes whose condition is stable and well-controlled do not pose an unreasonable risk to their health or to public safety. Also, as noted, studies indicate that hypoglycemia is the chief safety concern for drivers with diabetes, and the evidence reports show a connection between insulin use and the risk of hypoglycemia. FMCSA has determined that the inconvenience and expense for drivers, and the administrative burden of an exemption program are no longer necessary to address concerns of hypoglycemia and meet the statutory requirement that drivers with ITDM maintain a physical condition that “is adequate to enable them to operate (CMVs) safely.” 49 U.S.C. 31136(a)(3). The principal reason for codifying medical qualification standards for ITDM drivers is to eliminate the prohibition on physically qualifying these drivers, thereby promoting their ability to earn a living without the inconvenience and added costs of obtaining and maintaining an exemption. As stated above, evidence indicates that these drivers are reasonably safe to drive if their diabetes is stable and well-controlled.

In this proposed rule, FMCSA would address hypoglycemia as a driver health and operational safety risk by establishing a regulatory protocol to ensure proper disease monitoring and management for drivers using insulin. The Agency is proposing to allow drivers with ITDM to be medically qualified. As a result, the exemption program established in the 2003 and 2005 notices would be unnecessary, and the notices would be withdrawn when this final rule becomes effective. These actions are consistent with the MRB recommendations. Further, this rulemaking would allow healthcare professionals familiar with a driver's physical condition to communicate directly with each other, appropriately ensuring that the MEs have the information necessary to complete the certificate attesting to the driver's medical qualifications. The practice of medical certification through MEs is more efficient and is reflective of congressional intent to have MEs on the National Registry make an individualized assessment of a particular driver's health status and ability to operate a CMV safely.

Contrary to the MRB recommendations, the Agency is not proposing to prohibit drivers with ITDM from being medically qualified to operate CMVs carrying passengers and hazardous materials. The risk posed by a driver with stable, well-controlled ITDM is very low in general. Further, there is no available evidence to support such a prohibition, and, as noted, under section 4129 of SAFETEA-LU, FMCSA may not hold drivers with ITDM “to a higher standard of physical qualification . . . than other individuals . . . except to the extent that limited operating, monitoring, and medical requirements are deemed medically necessary under regulations.” In addition, the current exemption program permits these drivers to qualify for passenger carrying and hazardous materials transportation. The Agency requests public comment specifically on this point, however.

In addition, FMCSA is not proposing to adopt the MRB recommendation to require annual or more frequent medical recertification for all drivers with diabetes mellitus. The proposed requirements apply only to drivers with ITDM. Current regulations do not prohibit any drivers with non-insulin treated diabetes mellitus from being qualified medically to operate CMVs. Finding no medical necessity for such a prohibition, the Agency is not proposing such a change. Furthermore, although the MRB recommended evaluation by a licensed physician, the Agency believes the TC working in conjunction with the ME, who is certified by the National Registry and working within the regulatory framework under part 391, meets the statutory requirement under 49 U.S.C. 31136(a)(3) for periodic physical examinations of drivers. The Agency seeks comment on these issues.

Today's proposed rule would amend 49 CFR part 391 by revising §§ 391.41 and 391.45 and by adding new § 391.46 to address driver health and public safety concerns associated with hypoglycemia related to diabetes and its control through insulin. The elements of the proposed rule are limited and medically necessary under section 4129(d) of SAFETEA-LU, ensure that the physical condition of drivers with ITDM is adequate to enable them to operate CMVs safely as required by 49 U.S.C. 31136(a)(3), and align with current best medical practice standards for monitoring and managing ITDM. In brief, the Agency proposes the following elements:

A driver with ITDM must have an annual or more frequent evaluation by a TC prior to a DOT medical examination by a certified ME. This proposed requirement is consistent with the MRB recommendations, except that the MRB recommended application to all drivers with diabetes mellitus. For the reason stated above, FMCSA is proposing this requirement only for drivers with ITDM.

The driver must keep blood glucose records as determined by the TC and submit those records to his or her TC at the evaluation. This proposed requirement is consistent with the MRB recommendation that drivers with ITDM monitor blood glucose levels and submit logs as part of their annual evaluation.

The ME must obtain written notification from the driver's TC, who has determined whether, in the preceding 12 months, the driver had a severe hypoglycemic reaction or demonstrated hypoglycemic unawareness and monitored and managed the condition properly as evidenced by blood glucose records. This proposed requirement is consistent with the MRB recommendation that drivers with ITDM be free of severe hypoglycemia and hypoglycemia unawareness, and that these drivers properly monitor and manage the condition.

At least annually, an ME, listed on the National Registry, must examine and certify that the driver is free of complications that would impair the driver's ability to operate a CMV safely and only renew the medical certificate for up to 1 year. This proposed requirement is consistent with the MRB recommendation for annual or more frequent recertification. For the reason stated above, FMCSA is proposing this requirement only for drivers with ITDM.

In contrast with the current exemption program, the proposed rule would require an annual evaluation by a TC instead of an evaluation by an endocrinologist and an annual or more frequent DOT medical examination by a certified ME to determine if medical certification is warranted. Evaluation by a TC allows for the individualized assessment of drivers with ITDM, which is consistent with the recommendations of the ADA and other organizations concerned with diagnosis and treatment of the disease. Most importantly, under section 4129(a) of SAFETEA-LU, Congress expressly directed FMCSA to modify the exemption program to “provide for the individual assessment of applicants who use insulin to treat their diabetes and who are, except for their use of insulin, otherwise qualified under the [FMCSRs].” FMCSA believes that a similar provision for an individual assessment is also appropriate in this rule. Further, although the ADA, the U.S. National Institutes of Health, and other organizations urge yearly assessments for individuals with diabetes by a physician or health care professional knowledgeable about the disease, none of these groups calls for yearly evaluations by endocrinologists. The National Institute of Diabetes and Digestive and Kidney Diseases notes that most people with diabetes receive care from a primary care physician—generally an internist or family practice doctor. Indeed, a requirement to be evaluated by an endocrinologist now seems impracticable for most drivers with ITDM. According to the American Board of Internal Medicine, there are only about 5,300 board-certified endocrinologists in the United States, approximately 1,300 of which do not provide clinical care.25

Reasonable persons with ITDM have every incentive to manage their condition so that the disease is stable and well-controlled, because the failure to take care of themselves not only would affect the quality of life, but also would significantly increase the risk of a hypoglycemic event. For a CMV driver, this situation would result in the inability to renew the required medical certificate and to earn an income through driving a CMV.

If a driver who has not used insulin previously begins using insulin for control of diabetes mellitus, the driver would be required to have an examination by a TC prior to the required DOT medical examination by a certified ME . The ME would use medical information from the TC in conjunction with the medical certification examination to determine whether a driver new to insulin treatment qualifies for medical certification. Essentially, in issuing a MEC under FMCSA regulations, the ME will reflect his or her evaluation that such drivers are free of complications that might impair the ability to operate a CMV safely in interstate commerce.

For all drivers with ITDM, the annual visit with the TC would ensure that a driver is complying with an appropriate standard of care for individuals with that condition, and it would allow the TC to monitor any of the other progressive conditions associated with diabetes. Although the proposed rule has no requirement for hypoglycemia awareness training, the annual or more frequent ME certification exam provides an opportunity for intervention should the TC evaluation, and the ME's own examination, provide evidence of hypoglycemia unawareness that impairs safe driving. The ME will request that the TC provide written notification regarding the ITDM driver's disease management prior to the examination of the driver.

The annual or more frequent requirement for a new MEC aligns with the current interval specified under the directives in the notices of final disposition and with the interval specified for drivers with ITDM by the Canadian Council of Motor Transport Administrators. The determination of whether a driver with ITDM is eligible to receive a MEC would rest with the ME who, working under part 391 with information provided by the TC, is authorized by statute to conduct DOT medical examinations.

The proposed rule would not change the requirement under 49 CFR 392.3 for every CMV driver, including those with ITDM, to refrain from operating a CMV while the driver's ability or alertness is impaired in a way that would compromise safety. The driver's knowledge of the issues surrounding ITDM, appropriate monitoring protocols, and equipment and supplies are still very important. The proposed rule would not allow drivers with ITDM with licenses issued in Canada or Mexico to operate a CMV in the United States. Drivers from Mexico with a Licencia Federal de Conductor (LFC) generally may operate in the United States. 49 CFR 383.23(b), n. 1 and 391.41(a)(1)(i). But Mexico does not issue an LFC to any driver with diabetes. Under the terms of the 1998 reciprocity agreement with Canada, a Canadian driver with ITDM holding a license issued by a Canadian province is not authorized to operate a CMV in the United States.

In 1994, at the termination of the ITDM waiver program described in the Background section of this NPRM, FHWA allowed drivers holding waivers to continue to operate CMVs in interstate commerce under the grandfather provisions of 49 CFR 391.64. The requirements in proposed § 391.46 reflect limited and necessary diabetes monitoring and management practices based on the results of the ADA studies and the evidence reports. On the other hand, under the current requirements in § 391.64, a driver with ITDM must continue to receive an annual endocrinologist examination, carry an absorbable source of glucose, and meet other requirements that FMCSA has determined are impracticable or unenforceable. If the requirements proposed today are adopted, the Agency believes that grandfathering provisions may be redundant because the individuals with waivers would comply already with the necessary elements of § 391.64 (e.g., otherwise qualifying under § 391.41 and annual examination by an ME), or would be able to meet a less restrictive requirement (e.g., annual examination by a TC rather than a board-certified endocrinologist). However, FMCSA seeks comments regarding whether removing these grandfathering provisions would adversely affect any driver that is operating currently under § 391.64.

The current exemption program requires drivers with ITDM to obtain a signed statement from an ophthalmologist or optometrist that the applicant has been examined, meets the vision standard in § 391.41(b) or has an exemption, and does not have diabetic retinopathy. If the applicant has diabetic retinopathy, he or she must be tested by an ophthalmologist to determine whether the condition is unstable and proliferative. Following that exam, the applicant must submit a separate signed statement from the ophthalmologist certifying that the applicant's diabetic retinopathy is not unstable or proliferative.

The proposed rule would not require drivers with ITDM to be examined or obtain a signed statement from an ophthalmologist or optometrist to meet the vision standard or a separate examination for diabetic retinopathy. As stated above, FMCSA believes that reasonable persons with ITDM have every incentive to manage their condition so that the disease is stable and well-controlled, because the failure to care for themselves would affect their quality of life. This includes examinations by an optometrist or ophthalmologist to assess the individual's long term visual health. The regulatory concern for any driver is whether he or she can meet the standards in § 391.41(b)(10). FMCSA believes that meeting the vision acuity standard as part of the annual exam by an ME listed in the National Registry of Certified Medical Examiners provides reasonable certainty of discovering and mitigating risks associated with any safety-related condition that would interfere with meeting the standard, including diabetic retinopathy. This approach also would be less costly for drivers who would incur the cost of seeing a vision specialist only if there are signs of a degenerative condition, in contrast to the exemption program requirement that these drivers must see an optometrist or ophthalmologist to meet visual acuity requirements under § 391.41(b). The Agency requests comment on the need for a person with ITDM to be examined by an optometrist or ophthalmologist as a condition of passing the physical exam.

This NPRM addresses the physical qualification standards for interstate CMV drivers treating their diabetes mellitus with insulin. This section-by-section analysis describes the proposed provisions in numerical order.

Section 391.41 would be amended to allow drivers treating diabetes mellitus with insulin to operate commercial motor vehicles in interstate commerce provided they meet the conditions specified in the new § 391.46. Paragraph (b)(3) would be revised to allow a person to meet the physical qualification standards to operate a commercial motor vehicle either by (1) having no medical history or diagnosis of diabetes mellitus requiring insulin for control or (2) meeting the requirements in new § 391.46.

Section 391.45 would be revised to renumber the section for clarity. Existing paragraph (b)(1) would become new paragraph (b), requiring any driver who has not been medically examined and certified as qualified to operate a CMV during the preceding 24 months, unless the driver is required to be examined and certified in accordance with paragraphs (c), (d), (e) or (f) of this section. Existing paragraph (b)(2) would be divided into new paragraphs (c) and (d). Existing paragraph (c) would become new paragraph (f). New paragraph (e) would require any driver who has diabetes mellitus requiring insulin for control and who has been qualified for a MEC under the standards in § 391.46 to be medically examined and certified as qualified to drive at least every 12 months.

A new § 391.46 would be added containing the requirements that a person who has diabetes mellitus currently requiring insulin for control must meet to be physically qualified to drive a CMV in accordance with specific standards for such drivers.

Proposed paragraph (a) would require that a person with diabetes mellitus requiring insulin for control is physically qualified to operate a CMV in interstate commerce if he or she otherwise meets the standards in § 391.41 and also meets the requirements in paragraphs (b) and (c) of proposed § 391.46.

Paragraph (b) would require the person with diabetes mellitus currently requiring insulin for control to have an evaluation by his or her TC who would determine that the driver had not experienced a recent severe hypoglycemic reaction and was properly managing the disease. A definition of TC would be added to the provision. Paragraph (b) also would require a person with diabetes mellitus requiring insulin for control to be medically examined and certified under § 391.43 by an ME. These examinations would occur at least annually. The ME must obtain and review written notification from the TC that the person is properly managing the diabetes mellitus. Paragraph (c) would require that the medically certified driver with ITDM maintain his or her blood glucose records per the guidance of the TC for the period of certification and submit those records to the TC at the time of the evaluation.

Under E.O. 12866, “Regulatory Planning and Review” (issued September 30, 1993, published October 4 at 58 FR 51735, as supplemented by E.O. 13563 and DOT policies and procedures, FMCSA must determine whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review. E.O. 12866 defines “significant regulatory action” as one likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal government or communities.

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency.

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof.

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O.

FMCSA determined this proposed rule is not a “significant regulatory action” under Executive Order 12866, Regulatory Planning and Review, and not significant under DOT regulatory policies and procedures. The Agency estimates that the economic impact of this proposed rule will not exceed the annual $100 million threshold for economic significance.

This Regulatory Impact Analysis (RIA) provides an assessment of the costs and benefits of the Qualifications of Drivers: Diabetes NPRM. FMCSA proposes to allow the operation of CMVs in interstate commerce by drivers with well-controlled ITDM whose physical condition allows them to operate safely. Under current medical qualifications requirements an insulin-dependent driver does not meet the qualifications of § 391.41(b)(3) to receive a MEC to operate CMVs in interstate commerce. However, FMCSA may grant the driver with stable, well-controlled ITDM an exemption to drive in interstate commerce under the procedures in 49 CFR part 381 and the protocols in the 2003 Notice of Final Disposition as updated in 2005.26

The proposed rule would change the physical qualification standards to allow the ME to qualify drivers with stable, well-controlled ITDM to operate CMVs in interstate commerce. FMCSA has evaluated the costs and benefits of the proposed rule using the current exemption program as a baseline for comparison. The proposed rule and the exemption program differ on key provisions that affect costs, which are summarized below.

The majority of CMV drivers receive MECs that are valid for two years. The proposed rule would require drivers with ITDM to obtain MECs at least annually as currently required by the exemption program. However these drivers would no longer be required to obtain an exemption from FMCSA. A driver with stable, well-controlled ITDM who meets the requirements of the proposed rule could obtain a MEC and continue to earn income operating CMVs in interstate commerce without the additional expense and delay of applying for an exemption.

Not all drivers who seek to be medically certified under the standards described in this proposed rule would be medically qualified to operate a CMV, however estimating the number of drivers who would join the driver population is difficult. As a result the Agency has performed a threshold analysis using various percentages of ITDM-medically qualified drivers to determine possible costs of the rule annually in millions of dollars. Further information on this analysis may be found in the RIA in the docket.

In this analysis, we provide cost estimates if the estimated rates of ITDM-qualified driver populations are: 33.3%, 66.7%, and 100%. The Agency has no estimate of the actual rate of ITDM-qualified drivers certified under the qualifications proposed here and feels that 33.3%, 66.7%, and 100% acceptance rates allow the reader to understand the range of possible impacts of the rule. This has no impact on the rule's cost per driver which will be discussed shortly.

The proposed rule is less onerous for both drivers with ITDM and for the Agency. The Agency would change the requirement from an annual evaluation by a board-certified endocrinologist to one with a TC because the treating licensed healthcare professional is capable of determining whether the driver's condition is well-controlled. The revised requirement also would eliminate quarterly reports from the board-certified endocrinologist, the sharing of information between the ME on the National Registry and the TC would ensure that only drivers who are controlling their ITDM would receive a 1-year medical certificate. The Agency would no longer review applications for exemptions, further reducing administrative costs for FMCSA. The rule would eliminate an annual eye exam, because a qualified ME on the Agency's National Registry could determine whether the driver meets the vision standard. For these reasons, the per-driver cost would be significantly lower under the proposed rule than under the current exemption program.

The table below compares costs of the current exemption program with projected costs of the proposed rule. As the Agency lacks sufficient data to project the affected population changes in subsequent years, the analysis projects this rule's total annual costs to remain constant in real terms during each of the ten years from the initial compliance date. A separate discussion of the annualized costs at the 7% discount rate for this rule is therefore unnecessary, as the annualized costs are identical to the corresponding discounted annual costs. The Agency seeks comments on the use and appropriateness of these ranges in the absence of additional data on the prevalence of ITDM-qualified drivers and their likelihood of participating in the proposal's certification program.

On a per-driver basis, the annual cost impact of this rule is consistent across all ITDM-qualified drivers. These costs include a driver's cost of time related to the DOT medical examination ($31 per hour) and a driver's expense for the out-of-cycle DOT medical examination ($120). Combined, the out-of-pocket cost per ITDM-qualified driver resulting from this proposal is $151 (= $31 + $120). If an ITDM-qualified driver presently participates in the medical exemption program, although he or she will still incur the annual $151 cost of this proposal, this driver will experience a significant cost reduction relative to the cost to participate in the current exemption program, discussed further in the RIA.

In addition to examining published literature on the safety risk of drivers with diabetes, the Agency has also examined the safety performance of drivers holding diabetes exemptions.

The table above titled “Diabetes Exemption Analysis Results” summarizes the crash performance of 1,730 drivers in the Diabetes Exemption Program. Crash statistics for the pre-exemption career and (if any) post-exemption career 28 of the drivers are presented, but the primary periods of interest are the months and years during which a driver was granted an exemption. As can be seen, as a whole, drivers in the exemption program were involved in 74 crashes, none of them fatal.

This record of crash history can be compared against the crash performance of drivers as a whole. Because one can examine MCMIS reported crashes only for drivers in the exemption program, the analysis of the safety performance of drivers as a whole is restricted to MCMIS reported crashes. The Agency lacks data on vehicle miles traveled for drivers in the exemption program, however, and the best indication of exposure is therefore years of driving.

The exemption program provides data on when an exemption was granted, renewed, rescinded, or terminated. These data allow one to determine, for each exemption holder, approximately how many months and years each driver operated a CMV while holding an exemption. FMCSA was able to analyze data for 1,730 drivers involved in 74 crashes. Some drivers could not be analyzed because of missing data. (They had a termination date but no acceptance date, they could not be matched to a driver's license record, or some other data problem made it impossible to calculate the number of years they had been driving or to match their exemption to a crash record.) The 1,730 drivers had an average of 3.293 years of driving experience in the exemption program. On a per-driver, per-year basis, the crash rate for drivers with ITDM in the exemption program was 0.013 (0.0130 = 74 crashes ÷ 1,730 drivers ÷ 3.293 years).

Data indicate that the safety performance for CMV drivers with ITDM who hold exemptions is as good as that of the general population of CMV drivers. The table below shows crashes reported to MCMIS for all FMCSA-regulated CMV drivers from 2005 to 2011. Over this period, there was an average of 134,191 crashes reported to MCMIS each year. FMCSA estimates that there are currently 3.5 million active CMV drivers in FMCSA-regulated operations. Consequently, the average number of crashes per year per active CMV driver is about 0.038 (134,191 ÷ 3,500,000).

The proposed rule would eliminate the blanket prohibition against drivers with ITDM so that the exemption program would no longer represent the sole means of physically qualifying to operate CMVs. The Agency believes that the benefits of the proposed rule to ITDM individuals are significant. These individuals may pursue interstate driving careers after demonstrating to a ME that their condition is well-controlled and that their ability to operate CMVs safely is not compromised by their medical condition. Although the annual costs will be higher because of the increased number of drivers with stable, well-controlled ITDM who could be eligible for medical certification under the new rule, the Agency expects that drivers with ITDM will benefit from greater employment opportunities, and will realize benefits to their health through improved monitoring of their ITDM.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) (RFA) requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. “Small entities” consist of small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with a population of less than 50,000.29

Accordingly, DOT policy requires an analysis of the impact of all regulations on small entities and mandates that agencies strive to lessen any adverse effects on these businesses. Under the standards of the RFA, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857) (SBREFA), the proposed rule does not impose a significant economic impact on a substantial number of small entities (SEISNOSE) because the medical standards apply to individuals seeking to operate a CMV in interstate commerce; they are qualifications for an occupation rather than for small entities. Although there are individual drivers who are self-employed, qualifications for an occupation are not considered a small business issue.

Consequently, I certify that the proposed action will not have a significant economic impact on a substantial number of small entities. FMCSA invites comment from members of the public who believe there will be a significant impact either on small businesses or on governmental jurisdictions with a population of less than 50,000.

Under section 213(a) of SBREFA, FMCSA wants to assist small entities in understanding this proposed rule so that they can better evaluate its effects on themselves and participate in the rulemaking initiative. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult the FMCSA point of contact, Ms. Linda Phillips, using the contact information in the FOR FURTHER INFORMATION CONTACT section of this proposed rule.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, taken together, or by the private sector of $151 million (which is the value in 2012 after adjusting for inflation $100 million from 1995) or more in any 1 year. FMCSA's assessment is that this proposed rule would not result in such an expenditure.

FMCSA analyzed this proposed rulemaking for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and determined under our environmental procedures Order 5610.1, published March 1, 2004, (69 FR 9680) that this NPRM does not have any significant impact on the environment. In addition, the actions in this rulemaking are categorically excluded from further analysis and documentation per paragraph 6(b) and 6(s)(7) of Appendix 2 of FMCSA's Order 5610.1. A Categorical Exclusion determination is available for inspection or copying in the www.regulations.gov Web site listed under ADDRESSES.

FMCSA analyzed this proposed rule under the Clean Air Act, as amended (CAA), section 176(c) (42 U.S.C. 7401 et seq.), and implementing regulations promulgated by the Environmental Protection Agency. The Agency has determined that this proposed rule is exempt from the CAA's general conformity requirement since the action results in no increase in emissions.

Under E.O. 12898, each Federal agency must identify and address, as appropriate, “disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and low-income populations” in the United States, its possessions, and territories. FMCSA evaluated the environmental justice effects of this proposed rule in accordance with the E.O., and has determined that no environmental justice issue is associated with this proposed rule, nor is there any collective environmental impact that would result from its promulgation.

Under the Paperwork Reduction Act of 1995, a Federal agency must obtain approval from the OMB for each collection of information it conducts, sponsors, or requires through regulations. 44 U.S.C. 3501-3520. Current exemption program applicants provide personal, employee health, and driving information during the application process. In the currently drafted supporting statement for the Information Collection Request (ICR), “Medical Qualifications of Drivers” (OMB control number 2126-0006), FMCSA attributes 2,219 annual burden hours to the applications made by CMV drivers to the current exemption program, and this proposed rule would eliminate this entire burden. However it would add fewer burden hours for the information collection of the TC who prepares written notification for the ME on the driver health, the completion of the ME report and results, and the ME's submission of the exam data and Medical Certificates to FMCSA. The supporting statement for this ICR is on display in the docket for your review and comment.

E.O. 12630 requires Federal agencies to consider the potential takings implications of their proposed actions, decisions, or regulations on constitutionally protected property rights, and document takings implications in all significant rulemaking documents that must be submitted to the OMB. FMCSA has determined that this proposed rule would not effect a taking of private property or otherwise have taking implications under E.O. 12630.

This proposed rule meets applicable standards in sections 3(a) (regarding the general duty to review regulations) and 3(b)(2) (addressing important issues affecting clarity and general draftsmanship) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

E.O. 13045, “Protection of Children from Environmental Health Risks and Safety Risks,” requires that agencies issuing economically significant rules, which concern an environmental health or safety risk that an Agency has reason to believe may disproportionately affect children, must include an evaluation of the environmental health and safety effects of the regulation on children. 62 FR 19885 (Apr. 23, 1997). Section 5 of E.O. 13045 directs an agency to submit for a covered regulatory action an evaluation of its environmental health or safety effects on children. The FMCSA has determined that this proposed rule is not a covered regulatory action as defined under E.O. 13045, because this proposal would not constitute an environmental health risk or safety risk that would disproportionately affect children.

Under E.O. 13132, a rule has implications for federalism if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on States or localities. FMCSA has analyzed this proposed rule under that E.O. and has determined that it does not have implications for federalism. Nothing in this proposed rule would preempt State law or regulation or impose substantial direct compliance costs on these governmental entities.

The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.

FMCSA analyzed this proposed rule in accordance with the principles and criteria in E.O. 13175, Consultation and Coordination with Indian Tribal Governments. This rulemaking does not significantly or uniquely affect Indian tribal governments or impose substantial direct compliance costs on tribal governments. Thus, the funding and consultation requirements of E.O. 13175 do not apply, and no tribal summary impact statement is required.

FMCSA has analyzed this proposed rule under E.O. 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.” This proposal is not a significant energy action within the meaning of section 4(b) of the E.O. This proposal is not economically significant and would not have a significant adverse effect on the supply, distribution, or use of energy.

Section 522 of title I of division H of the Consolidated Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a privacy impact assessment (PIA) of a regulation that will affect the privacy of individuals. In accordance with this Act, a privacy impact analysis is warranted to address any privacy implications contemplated in the proposed rulemaking. The Agency submitted a Privacy Threshold Assessment analyzing the privacy implications to the Department of Transportation, Office of the Secretary's Privacy Office to determine whether a PIA is required. The DOT Chief Privacy Officer has evaluated the risks and effects that this rulemaking might have on collecting, storing, and sharing Personally Identifying Information and has examined protections and alternative information handling processes in developing the proposal in order to mitigate potential privacy risks. The privacy risks and effects associated with this proposed rule are not unique and have previously been addressed by the medical examination/certification requirements in the National Registry of Certified Medical Examiners (National Registry) and the Medical Examiner's Certification Integration PIA published on the DOT Privacy Web site and the DOT/FMCSA 009—National Registry of Certified Medical Examiners System of Records Notice (SORN) (77 FR 24247) published on April 23, 2012. An additional PIA and SORN for this rulemaking is not required.

The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) are standards that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

The E-Government Act of 2002, Public Law 107-347, sec. 208, 116 Stat. 2899, 2921 (Dec. 17, 2002), requires Federal agencies to conduct a PIA for new or substantially changed technology that collects, maintains, or disseminates information in an identifiable form. FMCSA has determined that this proposed rulemaking does not involve new or substantially changed technology.

For the reasons set forth in the preamble, FMCSA proposes to amend 49 CFR part 391 as follows:

On March 03, 2015, we published a positive 90-day finding on a petition from Friends of Animals requesting that we list the common thresher shark Alopias vulpinus as endangered or threatened under the ESA, or, in the alternative, delineate six distinct population segments (DPSs) of the common thresher shark, as described in the petition, and list them as endangered or threatened. In that notice we also announced the initiation of a status review and solicited information from the public to help inform the status review of the species and determine its risk of extinction.

We received a request to extend the public comment period by 60 days in order to provide the public with additional time to gather relevant information and adequately comment on the validity of the petitioned action in a meaningful and constructive manner. In addition, a technical error on the Regulations.gov Web site prevented the public from accessing materials in the docket folder for the 90-day finding, including existing public comments and other substantive materials. We considered the request and concluded that a 60-day extension should allow sufficient time for responders to submit comments without significantly delaying the completion of the status review. We are therefore extending the close of the public comment period from May 04, 2015 to July 6, 2015. Although we have extended the public comment period, we are unable to extend the deadline for completing the status review. As such, we urge members of the public to submit their comments as soon as possible to allow us more time to review and incorporate the submitted information where appropriate.

The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).