On February 25, 1994 (59 FR 9146), NRC published an ANPR to seek information to determine whether an amendment to its regulations governing the release of radionuclides from licensed nuclear facilities into sanitary sewer systems was needed. NRC was considering revising the approach to limiting these releases because of the potential effects of newly-developed sewage treatment technologies on radionuclide reconcentration during wastewater treatment. The Commission requested advice and recommendations on several proposals and asked related questions regarding whether and in what way the regulations governing the release of radionuclides from licensed nuclear facilities into sanitary sewer systems should be changed. NRC received seventy-four comment letters in response to the ANPR. The comment period expired on May 26, 1994.

Because there were concerns raised on the broader issue of long-term effects of releases of radioactive materials into sanitary sewer systems, action on the ANPR was deferred until studies were conducted regarding potential radioactive contamination in sewage sludge. Since that time, NRC participated in the Interagency Steering Committee of Radiation Standards (ISCORS) and co-chaired, with the Environmental Protection Agency (EPA), the Sewage Sludge Subcommittee to facilitate a systematic and thorough study of the potential concerns related to radionuclides in sewage sludge and to obtain data to support a technical basis for a regulatory decision.

NRC regulations governing the release of licensed material into sanitary sewer systems can be found in 10 CFR 20.2003. This regulation was published in the Federal Register (56 FR 23360; May 21, 1991) as part of an overall revision of NRC standards for protection against radiation. Licensees were required to implement this regulation by January 1, 1993. As part of the 1991 revision of 10 CFR Part 20 regulations, NRC removed the broad provision that allowed the release of non-biological insoluble materials into sanitary sewers because of the potential for this material to reconcentrate in sewers, publicly owned treatment works (POTWs), and sewage sludge. The current NRC regulations require that any licensed material discharged into a sanitary sewer system must be readily soluble in water or be readily dispersible biological material. In addition, the concentration limits for radionuclides released into a sanitary sewer system, listed in Table 3 of the Appendix B to Part 20, were reduced by a factor of 10 as part of an overall reduction in effluent release limits. In addition to the limits in 10 CFR 20.2003, NRC recommends that licensees should maintain doses as low as is reasonably achievable (ALARA) by setting goals for effluent concentrations and quantities to be only a modest fraction (10 to 20 percent) of their allowable limits, as described in NRC Regulatory Guide 8.37, “ALARA Levels for Effluents from Materials Facilities,” dated July 1993. NRC also conducts periodic inspections to ensure that licensees are in compliance with NRC regulations.

In May 1992, NRC issued the results of a scoping study in NUREG/CR-5814, “Evaluation of Exposure Pathways to Man from Disposal of Radioactive Materials into Sanitary Sewer Systems,” which evaluated the potential radiological doses to POTW workers and members of the public from exposure to radionuclides in sewage sludge. The first part of the analysis estimated the potential doses to workers for five cases in which radioactive materials were detected at POTWs (Tonawanda, NY; Grand Island, NY; Royersford, PA; Oak Ridge, TN; and Washington, DC). Doses from the case studies were estimated to range from less than 10 microsieverts per year (μSv/yr) (1 millirem per year (mrem/yr)) to 930 μSv/yr (93 mrem/yr) for members of the public, using a deterministic scenario analysis and the reported radionuclide concentrations and/or discharges. The second part of the study estimated the maximum radiation exposures to POTW workers and others who could be affected by low levels of man-made radioactivity in wastewater. The quantities of radionuclides released into the sewer systems were assumed to be the maximum allowed under NRC regulations at the time. Estimates of the hypothetical, maximum exposures to workers ranged from zero to a dose roughly equal to the dose individuals receive from natural background radiation.

In May 1994, the U.S. General Accounting Office (GAO, now U.S. Government Accountability Office) issued a report, GAO/RCED-94-133, “Nuclear Regulation: Action Needed to Control Radioactive Contamination at Sewage Treatment Plants”, that described nine cases where contamination was found in sewage sludge or ash or in wastewater collection systems. GAO concluded that the full extent of contamination nationwide was unknown. GAO also concluded that the “problem of radioactive contamination of sludge and ash in the reported cases was the result, in large part, of NRC's regulation, which was incorrectly based on the assumption that radioactive materials would flow through treatment systems and not concentrate.” In June 1994, a joint U.S. House of Representatives and Senate hearing (June 21, 1994; S. Hrg. 103-1034) was held to officially release and address questions raised in the GAO report. At the hearing, NRC and EPA agreed to cooperate to develop guidance for POTWs and to collect more data on the concentration of radioactive materials in samples of sewage sludge and ash from POTWs nationwide.

Between 1994 and 1997, Federal, State, and industry studies were conducted to assess reconcentration of radioactive materials that are released into sanitary sewer systems. In December 1994, NRC published NUREG/CR-6289, “Reconcentration of Radioactive Material Released into Sanitary Sewers in Accordance with 10 CFR Part 20.” A review of the literature demonstrated that some radioactive materials discharged into sanitary sewer systems reconcentrate in sewage sludge. However, the report concluded that the available data were not sufficient to assess the adequacy of the requirements in 10 CFR 20.2003 in preventing occurrences of radionuclide reconcentration in sewage sludge at levels which present significant risk to the public; nor is the available data sufficient to suggest strategies for changing the requirements.

In 1996, the Association of Metropolitan Sewerage Agencies (AMSA) conducted a limited survey of reconcentration of radioactivity in sewage sludge and ash samples from some of its member POTWs. Samples were obtained from 55 wastewater treatment plants in 17 States. The most significant sources of radioactivity were potassium and radium isotopes, which are Naturally Occurring Radioactive Materials (NORM). In December 1997, the Washington State Department of Health issued a report WDOH/320-013, “The Presence of Radionuclides in Sewage Sludge and Their Effect on Human Health,” that was based on sludge samples taken at six POTWs in the State. The report concluded that that there was no indication that radioactive material in sewage sludge in the State of Washington poses a health risk.

The Interagency Steering Committee on Radiation Standards (ISCORS) was formed in 1995, to address inconsistencies, gaps, and overlaps in current radiation protection standards. In 1996, the Sewage Sludge Subcommittee of ISCORS was formed to coordinate efforts to address the recommendations in the 1994 GAO Report. Between 1998 and 2000, the EPA and NRC (through the ISCORS) jointly conducted a voluntary survey of POTW sewage sludge and ash to help assess the potential need for NRC and/or EPA regulatory decisions. Sludge and ash samples were analyzed from 313 POTWs, some of which had greater potential to receive releases of radionuclides from NRC and Agreement State licensees, and some of which were located in areas of the country with higher concentrations of NORM. In November 2003, the results of the survey were published in a final report, NUREG-1775, “ISCORS Assessment of Radioactivity in Sewage Sludge: Radiological Survey Results and Analysis.” No widespread or nationwide public health concern was identified by the survey and no excessive concentrations of radioactivity were observed in sludge or ash. The results indicated that the majority of samples with elevated radioactivity had elevated concentrations of NORM, such as radium, and did not have elevated concentrations of radionuclides from manmade sources.

In February, 2005, the Sewage Sludge Subcommittee published a report, NUREG-1783, “ISCORS Assessment of Radioactivity in Sewage Sludge: Modeling to Assess Radiation Doses.” This report contains dose modeling results for seven different sewage sludge management scenarios for POTW workers and members of the public. Results of the dose models and survey results indicated that there is no widespread concern to public health and safety from potential radiation exposures associated with the handling, beneficial use, and disposal of sewage sludge containing radioactive materials, including NORM.

In February, 2005, the Sewage Sludge Subcommittee also published a report, “ISCORS Assessment of Radioactivity in Sewage Sludge: Recommendations on Management of Radioactive Materials in Sewage Sludge and Ash at Publicly Owned Treatment Works;” (EPA 832-R-03-002B; ISCORS Technical Report 2004-04). This report provides guidance to: (1) Alert POTW operators, as well as State and Federal regulators, to the possibility that radioactive materials may concentrate in sewage sludge and incinerator ash; (2) inform POTW operators how to determine whether there are elevated levels of radioactive materials in the POTW's sludge or ash; and (3) assist POTW operators in identifying actions for reducing potential radiation exposure from sewage and ash.

The results of the survey and dose modeling work conducted by the ISCORS Sewage Sludge Subcommittee regarding radioactive materials in sewage sludge and ash provide a technical basis for withdrawing the ANPR. The survey demonstrated that the most significant levels of radioactive materials in POTWs are attributable to NORM. The dose modeling work indicated that, in general, the doses from licensed materials in sewage sludge present a sufficiently low health and safety risk to POTW workers and to the public under the current regulatory structure. Therefore, it is not necessary to modify the current restrictions regarding the release of radioactive materials into sanitary sewers (10 CFR 20.2003) as discussed in the ANPR. In addition, public comments indicated that several of the options discussed in the ANPR would be costly to implement and may not be consistent with efforts to maintain doses ALARA. For these reasons, NRC is withdrawing the ANPR.

In the ANPR, NRC invited comment on the following aspects of the regulation of release of radionuclides into sanitary sewers: The form of materials suitable for disposal, the limits on the total radioactivity of materials that can be released by a licensee into sanitary sewers in a year, also called the “total quantity limit,” the types of limits applied, and the exemption for medical patient excreta. The following is a summary of those comments and NRC responses.

The May 21, 1991, final rule (10 CFR 20.2003) allows soluble and readily dispersible biological material to be released but prohibits the release of any non-biological insoluble material. Because NRC recognized that new technologies for wastewater treatment, such as ion-exchange and some types of biological treatment, can reconcentrate radionuclides, NRC invited comments regarding whether and how regulations should account for the effects of different wastewater treatment technologies on radionuclide reconcentration. NRC also invited comments regarding the potential impacts that additional restrictions on the form of materials allowable for release into sanitary sewers would have on licensee operations. Public comments regarding the adequacy of the current restrictions also were received.

Comment: Nine commenters, including representatives of the New York State Energy Office, New York State Department of Environmental Conservation, AMSA, and the Department of Energy (DOE), expressed the view that the regulations should be reevaluated because of new sewage treatment technologies or should account for the effects of new technologies used to treat sewage or sewage sludge. One commenter suggested that NRC limits should account for a variety of POTW-specific factors, including sludge handling processes, and sludge disposal methods, and restrictions on the POTW's treated water discharge. Another commenter suggested NRC should take new sewage treatment technologies into account only if the results of NUREG/CR-6289, which was incomplete at the time the comment was made, indicated that new sewage treatment technologies had the potential to cause significant reconcentration of radionuclides in sewage sludge. Two commenters recommended NRC develop technology-specific reconcentration factors to help POTW operators to design appropriate pretreatment plans. A representative of DOE suggested NRC should expect that advances in the sewage treatment process would result in increasing concentration of radionuclides in sewage sludge. Two commenters recommended NRC regulations account for synergistic health effects of radiation and pollutants in wastewater, and one suggested NRC evaluate the synergistic effects of radiation and the chlorine and fluoride used in drinking water treatment.

Response: NRC acknowledges the commenters' support for regulations that would account for the reconcentration of radionuclides by wastewater treatment processes. However, the regulations will not be changed because the ANPR is being withdrawn for the reasons previously explained.

Comment: Four commenters expressed the view that NRC regulations should not take sewage treatment technologies into account. Reasons included uncertainty that new technologies will be implemented and a lack of information about the effects of the new technologies on radionuclide reconcentration. A representative of the State of Illinois Department of Nuclear Safety suggested NRC should keep informed of technological developments, but should not implement additional restrictions without significant evidence that the current restrictions are not adequate. Two commenters suggested that, rather than revising § 20.2003 to account for new treatment technologies, NRC should consider placing additional restrictions on individual licensees to provide the necessary protection to the receiving POTWs in unusual cases where the number of licensees, size of the sewage treatment plant or nature of the technology used at the treatment plant may cause doses above 100 mrem/yr. One commenter stated that it is unnecessary for NRC regulations to account for sewage sludge treatment technologies because local POTWs have the authority and mandate to account for these technologies by developing industrial water discharge permits pursuant to 40 CFR 403.5(c)(1).

Response: NRC acknowledges the commenters' opposition to the proposed rule change, which supports NRC's decision to withdraw the ANPR. With respect to the comment that POTWs have the authority and mandate to impose limits on radioactive materials released into sanitary sewers, NRC notes that, as described in Section 4.7 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B), POTWs may not have the same authority to regulate radioactive material as they do to regulate other materials released into sanitary sewers.

Comment: Eight commenters expressed the view that NRC regulations should account for the fact that several licensees may discharge to the same POTW, and, of those, five expressed the view that the regulations should also take the capacity of the POTW into account. Five commenters stated that restrictions on the release of nonradioactive pollutants established under EPA's National Pollutant Discharge Elimination System (NPDES) account for the capacity of the receiving POTW, the wastewater treatment systems used, and the number of industrial users discharging to a POTW, and suggested any new regulations governing the release of radioactive materials into sanitary sewers should take these factors into account. A representative of DOE expressed the view that changes to the regulations to account for multiple dischargers should be considered but may not be necessary because sanitary systems serving multiple licensees would probably be large systems in which the licensees' effluent would be diluted by many other inputs to the sewer system. One commenter suggested that, if limits on the total amount of radioactivity individual POTWs could receive were developed, any cases in which the limits are being exceeded by licensees that were already discharging sewage into the sewer system before the limits were developed should be handled on a case-by-case basis.

Response: NRC acknowledges the commenters' support for regulations that would account for the capacity of individual POTWs and the number of licensees discharging to a single POTW. However, the proposed change will not be implemented for the reasons previously explained.

Comment: Twenty-seven commenters were opposed to additional restrictions on the forms of material suitable for release into sanitary sewers. Twenty-one stated that the potential for significant reconcentration of radionuclides during wastewater treatment probably had been addressed by the May 21, 1991 changes to Part 20 (56 FR 23360) that restricted the forms of materials that could be released into sanitary sewers and lowered concentration limits. Another commenter expressed the view that it was unclear whether contamination described in the case studies discussed in the ANPR occurred because of violations of the existing regulations, and also that it would be inappropriate for NRC to respond to individual violations of regulatory requirements by making changes to the regulations for all licensees. Representatives of six licensees indicated that additional restrictions on the forms of material appropriate for disposal would impose a significant burden on their operations. Commenters listed the costs of building new storage facilities, analyzing samples of waste to determine whether insoluble radionuclides were present, and establishing new collection, handling, and disposal procedures as well as retraining of personnel as expenses that would be incurred if additional restrictions were imposed. In addition, three commenters expressed the concern that further restricting the forms of material appropriate for disposal in a sanitary sewer would not be consistent with NRC's policy that doses should be maintained ALARA because the additional waste handling that would be required would cause doses to workers that would not be justified based on the minimal dose to members of the public or POTW workers that might be avoided.

Response: NRC acknowledges the commenters' remarks, which support the withdrawal of the ANPR. However, the NRC staff notes the need to analyze samples of waste to determine if the waste contains insoluble radionuclides should not impose an additional burden because the restriction on releasing insoluble, non-biological wastes was already in place when the comment was made.

Comment: Twenty-three commenters encouraged NRC to continue to allow release of readily soluble wastes that met the quantity and concentration release criteria in 10 CFR Part 20. Twenty-one of those commenters indicated that they were unaware of any significant problems caused by the disposal of soluble radioactive material in sewer systems. Three commenters stated that they were not aware of any mechanisms that would reconcentrate the wastes typical of biomedical research in sewage sludge, and two of these stated that the activity levels were sufficiently low that reconcentration, even if it did occur, would not cause a significant dose.

Response: NRC acknowledges the commenters' support for the continuation of the current regulations which allow certain concentration and quantities of readily soluble radioactive material into sanitary sewers.

Comment: Two commenters suggested that NRC should change the regulation to re-establish disposal of dispersible non-biological materials. One commenter suggested disposal of non-biological dispersible materials should be allowed for materials that have half-lives of less than 100 days or are below the concentrations listed in 10 CFR Part 20 Appendix C.

Response: NRC acknowledges the commenters' suggestion that release of non-biological dispersible material into sanitary sewers be allowed. NRC understands that reconcentration of a radionuclide in sewage sludge can be limited by its half life. However, NRC has chosen not to change the regulation governing the release of radioactive material into sanitary sewers for the reasons previously explained.

Comment: Six commenters, including a representative of DOE, noted that the chemical form of materials released into the sewer can change, and that materials that are soluble when released may precipitate or sorb to solid particles in the sewer or treatment plant. A representative of the New York State Department of Environmental Conservation suggested NRC study not only the effect of new technologies on radionuclide solubilities, but also how the solubility of radioactive materials change in sanitary sewers. A representative of DOE noted that precipitation and sorption could cause risks to individuals who work in POTWs, work in close contact with sewers, or who incinerate or use wastewater treatment sludge. In addition, the commenter remarked that, while it appeared to be reasonable to limit sewer releases to soluble and dispersible biological materials, NRC should realize that licensees could release insoluble or nondispersible materials to sewer systems inadvertently. One commenter expressed the view that NRC regulations should account not only for the form of material when released, but the form it was likely to take after being discharged.

Three commenters expressed the view that, because the form of a material discharged is likely to change when it reaches the sewer or POTW, the modification to 10 CFR 20 that eliminated disposal for non-biological “readily-dispersible” materials may not have removed the chance that radionuclides could reconcentrate in wastewater treatment sludge. Two commenters remarked that reconcentration of radionuclides probably would continue, in part because POTWs are designed to remove dissolved contaminants from wastewater. However, both commenters expressed the opinion that reconcentration is not necessarily a problem if the dose any individual is expected to receive from exposure to sewers, sewage, or sludge is low.

Response: NRC understands that materials that are released into the sewer in a soluble form can precipitate or sorb to solid materials in sewers or POTWs, as discussed in NUREG/CR-6289. Most of the commenters' concerns about the potential risk to POTW workers are addressed in the ISCORS dose modeling report (NUREG-1783), as previously explained. Although the ISCORS dose analysis (NUREG-1783) does not include an analysis of doses to workers that come into contact with sewers, those doses are expected to be limited because of the limited amount of time a worker would spend in close contact with a sewer and because of the relatively low doses predicted for most scenarios that involve contact with sewage sludge.

NRC acknowledges the concern that licensees may inadvertently dispose of insoluble non-biological material. NRC also acknowledges the suggestion that the regulations should account for changes in the form of materials that are likely to occur in sewers and POTWs and the concern about the efficacy of the 1991 revisions. For the reasons previously explained, NRC has decided not to change the regulations governing the release of radioactive material into sanitary sewers. However, NRC staff notes that, in addition to restrictions on form, NRC also has imposed annual limits in 10 CFR 20.2003(a)(4) on the total amount of radioactivity that can be released into sanitary sewers to limit the potential for reconcentration of radioactive material in sanitary sewers, sewage sludge, and sludge ash.

Comment: Five commenters supported additional restrictions on the form of materials that can be released into sanitary sewers. One commenter expressed the view that the practice, used by some medical research laboratories, of releasing pureed tissue samples to the sanitary sewer was distasteful. Another commenter expressed the opinion that NRC should impose any requirement that would minimize the amount of radioactivity in the environment.

Response: NRC acknowledges the commenters' support for additional restrictions on the forms of material suitable for release into sanitary sewers but is not changing the regulations because it believes the current approach is sufficiently protective, as previously explained.

Comment: Three commenters requested clarification regarding the distinction between soluble and readily dispersible materials. One requested that an information notice be produced to address materials used in the biotech industry. Another commenter expressed the concern that it would be difficult to demonstrate compliance with the restriction that only soluble and readily-dispersible biological materials be released into sanitary sewers if colloids that flow through filters and resins are classified as non-biological dispersible material. The commenter proposed an operational procedure to distinguish between soluble and readily dispersible materials. A representative of the New York State Department of Environmental Conservation noted that traces of insoluble radioactive material could be released into sewers with soluble materials, and requested that NRC establish a lower limit of detection for insoluble material.

Response: NRC acknowledges the commenters' request for additional guidance on how licensees should demonstrate the solubility of radioactive material released to sanitary sewers. Although NRC does not have plans to provide additional guidance on this issue, the staff notes that, as discussed in NRC Information Notice 94-007, licensees are free to develop alternative methods of demonstrating the solubility of materials they wish to release into sanitary sewers and to submit these procedures to NRC for evaluation on a case-by-case basis.

In the May 21, 1991 final rule, NRC did not change the total quantity limits, which allow a licensee to release 185 gigabecquerel (GBq) (5 curies (Ci)) of H-3, 37 GBq (1 Ci) of C-14, and 37 GBq (1Ci) of all other radioactive materials combined into sanitary sewers each year. The use of total quantity limits has been a long-standing requirement and was originally included in the rule (10 CFR 20.2003(a)(4)) to address concerns regarding the possibility for reconcentration of radionuclides. In the ANPR, NRC invited comments about the alternative approach of limiting the annual release of each radionuclide individually. NRC also invited comments about the current total quantity limits and the potential impacts that additional restrictions on the annual releases into sanitary sewers would have on licensees.

Prior to publishing the ANPR, NRC received a petition for rulemaking to amend 10 CFR 20.303 (superseded by § 20.2003) and § 20.305 (superseded by § 20.2004) from the Northeast Ohio Regional Sewer District (PRM-20-22). A notice of receipt of the petition was published in the Federal Register (58 FR 54071; October 20, 1993). The petitioner requested that NRC amend its regulations to require that all licensees provide at least 24 hours advance notice to the appropriate POTW before releasing radioactive material to the sanitary sewer system. The petitioner also requested that NRC exempt materials that enter the sanitary waste stream from the requirements regarding Commission approval for incineration under NRC's current regulations. NRC solicited comments on the petition in the ANPR. The denial of the petition was noticed in the Federal Register on January 27, 2005 (70 FR 3898).

Comment: Six comments received in response to the ANPR supported annual total quantity limits. Two commenters, including a representative of DOE, suggested total quantity limits should be retained because they help prevent reconcentration of radionuclides in sewage sludge and two supported the total quantity limits because they are easy for licensees and regulators to understand and implement. Two commenters, including the representative of DOE, suggested it may be worthwhile for NRC to evaluate whether the regulation could be optimized by changing the annual release limits for some radionuclides. A representative of the Illinois Department of Nuclear Safety expressed the opinion that the relatively low doses calculated for the case studies described in the ANPR and predicted for other scenarios in NUREG/CR-5814 indicated that reconcentration of radionuclides in sewage sludge could be addressed on a case-by-case basis rather than by changing the total quantity limits in § 20.2003.

Response: NRC acknowledges support for the current approach of using annual limits on the total quantity of radioactive material that can be released into sanitary sewers by a licensee. In accord with the commenters' suggestion, NRC performed a study to evaluate the reconcentration of various radiounuclides in POTWs, the results of which are discussed in NUREG/CR-6289.

Comment: A representative of the City of Oak Ridge made positive and negative statements about NRC annual total quantity limits. The commenter stated that both concentration and total quantity limits were necessary to ensure protection of workers and to ensure that traditional methods of sludge disposal remain acceptable. However, the commenter also expressed the view that the current values of the total quantity limits are too high and stated that disposal of 37 GBq (1 Ci) of Co-60 annually to the Oak Ridge POTW would result in unacceptably high concentrations of Co-60 in the POTW's sludge, especially if the material was released during a relatively short time period. The commenter also expressed the opinion that the total quantity limits are inappropriate for low specific activity radionuclides because of the large mass of the radionuclide that could be discharged. As an example, the commenter stated that release of 37 GBq (1 Ci) of U-238 to the city's POTW in a year would result in a mass concentration of uranium of more than 0.05 percent in the POTW's sludge, making the sludge licensable source material. In addition to these comments, the commenter suggested that, because the mean retention time of sludge at a POTW typically is one month or less, a monthly discharge limit would be more appropriate than an annual limit.

Response: NRC acknowledges the commenter's concern about the release of Co-60 to a POTW and the suggestion that quantity limits should be implemented on a monthly, rather than an annual, basis. The staff notes that the 1991 revision to 10 CFR Part 20 that eliminated the discharge of insoluble non-dispersible radioactive material into sanitary sewers was implemented to reduce the possibility of significant contamination of sewage sludge with insoluble radionuclides, such as Co-60. NRC has decided not to change the regulations governing sewer release of radioactive material for the reasons previously explained. NRC acknowledges the commenter's concern about the applicability of the total quantity limit to low specific activity radionuclides. However, NRC does not agree that the accumulation of large masses of low-specific activity radionuclides in POTWs is likely to be problematic. In addition POTWs have some authority to impose limits on the release of material into sanitary sewers when the purpose of the limits is not radiation protection, as discussed in Section 4.7 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B).

Comment: Twenty-three commenters described concerns about the current approach of limiting the total amount of radioactivity a licensee may release into a sanitary sewer system. Nineteen commenters expressed the opinion that it is not appropriate to apply the same total quantity limit to large and small facilities that discharge different amounts of sewage and therefore dilute radioactive materials to different extents. Another commenter stated that NRC should not attempt to impose total quantity limits on large facilities. Seventeen commenters expressed the view that NRC should consider relaxing the total quantity limits because of the new restriction on the form of material and lower release concentration limits implemented in the 1991 revision to 10 CFR Part 20. The commenters expressed the opinion that adherence to the new form and concentration limits may eliminate the need for total quantity limits. Three commenters suggested that, instead of limiting the total quantity of radioactivity a licensee could dispose of into a sewer, NRC should focus on the radionuclides and chemical forms of radionuclides that reconcentrate in POTWs to a significant extent. One commenter expressed the concern that a person could dispose of 37 GBq (1 Ci) of Cs-137 within a month while remaining in compliance with the current concentration and total quantity limits. Another commenter suggested concentration limits are sufficient and are superior to total quantity limits because concentration limits account for the total volume of water a licensee releases to the sanitary sewer system. The commenter noted that, although the nominal purpose of the total quantity limits is to eliminate reconcentration, the total quantity limits do not appear to prevent reconcentration, as evidenced by the case studies described in the ANPR. The commenter suggested reconcentration could be avoided by reducing the allowable concentrations of those radionuclides that have shown a tendency to reconcentrate in sewage sludge.

Response: NRC acknowledges the comment about the application of the same total quantity limit to large and small facilities, but believes that the system is appropriate. Because the total quantity limit is designed to reduce the potential for reconcentration of radionuclides at POTWs, an appropriate total quantity limit is more dependent on the volume of sewage received by a POTW than it is on the volume of a licensee's effluent.

NRC acknowledges the comment that total quantity limits should be relaxed or eliminated, but does not agree that the limits on form and concentration eliminate the need for annual quantity limits. As discussed in NUREG/CR-6289, the form of radionuclides can change upon entering a sewer or POTW because of sorption and precipitation. NRC also acknowledges the concern that total quantity limits did not prevent the cases of contamination discussed in the ANPR. NRC believes that limiting both the form and total quantity of material released into sanitary sewers is the best way to limit the potential for significant reconcentration of radionuclides released by licensees into sanitary sewers.

NRC acknowledges the commenters' suggestion that, instead of imposing total quantity limits, it should focus on those radionuclides that have been shown to reconcentrate in sewers or sewage sludge. NRC also acknowledges the commenter's concern about the discharge of Cs-137 but believes the current approach to be sufficiently protective for the reasons previously explained.

Comment: One commenter expressed the view that additional limitations on the release of H-3 and C-14 into sanitary sewers would not produce any public health benefit because any dose an individual received from sewer-disposed H-3 and C-14 would be negligible in comparison to the dose the individual would receive from naturally-produced H-3 and C-14.

Response: NRC acknowledges the commenter's view that additional restrictions on the quantities of H-3 and C-14 are unnecessary. The comment supports the withdrawal of the ANPR and the current total quantity limits which allow the annual release of 185 GBq (5 Ci) of H-3 and 37 GBq (1 Ci) of C-14 in addition to the release of 37 GBq (1 Ci) of all other radionuclides combined.

Comment: Eight licensees expressed the view that additional restrictions on the total quantity of radioactive material that could be released into sanitary sewers annually would have a severe negative impact on their facilities' operations. Representatives of a biomedical company, a university, and the National Institutes of Health (NIH) noted that a reduction in the total quantity limits would impose a significant financial burden on organizations involved in biotechnical research, development, or medical practice, especially if the limits were reduced to a point that liquid wastes would need to be solidified and disposed of as low level waste (LLW). The representative of NIH estimated that solidification and disposal of liquid wastes as LLW would cost NIH 2.8 million dollars annually, as of 1994. Two commenters remarked that companies would bear the additional expense of acquiring or building storage facilities or acquiring treatment technologies to remove radioactivity from liquid waste streams. One commenter noted that LLW disposal of many of the materials currently released into sanitary sewer systems would be a particularly unnecessary expense and inefficient use of LLW landfill space because, in many cases, the material would decay to negligible quantities before it reached the LLW landfill.

Five commenters associated with medical research facilities or companies that produce radiopharmaceuticals suggested additional restrictions on the total quantity of radioactive material that could be released into sanitary sewers annually could harm public health and safety by causing companies to limit biomedical research and development efforts. One of these commenters stated that the amount of radioactivity released into sanitary sewers in association with medical research was insignificant as compared to the amount of radioactivity released to sewers in patient excreta and concluded that release of radioactive materials associated with biomedical research should be allowed as long as the exemption for patient excreta is continued. Two commenters expressed the opinion that additional restrictions on the total quantity of radioactivity a licensee could release into sanitary sewers annually would not be consistent with efforts to maintain doses ALARA because workers would be exposed to radioactive material while processing liquid waste to make it suitable for LLW disposal.

A representative of a company that offers health physics services stated that, for most of its clients who want to release radioactive material into sanitary sewers, the most limiting factor is the annual total quantity limits. A representative of the University of California expressed concern that the numerical limits in 10 CFR 20.2003 would be lowered, although the university typically releases only 11.1 Gbq (0.2 Ci) of radioactivity into sanitary sewers each year.

Response: NRC acknowledges the commenter's concerns about the potential impacts of additional restrictions on the total quantity of radioactive material that a licensee can release to sewers annually. As previously explained, the additional restrictions discussed in the ANPR will not be implemented.

Comment: A representative of AMSA stated that, although the organization understands that lowering total quantity limits could impose financial burdens on licensees, additional restrictions are appropriate if they are needed to prevent contamination of sewage sludge.

Response: NRC acknowledges the commenter's statement, but has decided not to change the total quantity limits because it believes the current approach is sufficiently protective for the reasons previously explained.

Comment: Twenty-one letters received in response to the ANPR included comments on the Northeast Ohio Regional Sewer District's request for NRC to amend its regulations to require that all licensees provide at least 24 hours advance notice to the appropriate POTW before releasing radioactive material into a sanitary sewer system. Six of the twenty-one commenters supported a requirement for licensees to provide the sewage treatment plant with some type of reporting on the radioactive materials released into the sanitary sewer system. These commenters supported a wide range of reporting requirements, including the petitioner's request for a 24-hour advance notification before licensees release radioactive material, monthly or annual discharge reports, reports of releases that could be a threat to the POTW workers or the environment, or notification of large accidental releases. One commenter suggested licensees should analyze effluent samples and include the results in discharge reports. A representative of AMSA stated that advance notice of releases is necessary so that POTW operators can ensure worker health and safety and make appropriate decisions about sludge disposal and reuse.

Fifteen of the twenty-one commenters did not support such a requirement for licensees to provide at least 24-hour advance notice to the appropriate sewage treatment plant before releasing radioactive material into a sanitary sewer system. Several commenters said that a 24-hour advance notification would result in an unnecessary regulatory burden without providing additional protection against radiation or dose reduction. These commenters expressed the view that the existing regulations for discharges of licensed material maintain doses at or below the existing dose limits for members of the public and if licensees meet the ALARA goals, the 24-hour advance notification would be unnecessary. Several commenters noted that such notification would be impractical because most releases are continuous and involve very small quantities of radioactive material. For example, discharges from hospitals and medical facilities would change daily depending on the number of patients treated and types of treatment used.

Several commenters also noted that there could be large cost implications and regulatory burdens associated with such notification. In addition, commenters were concerned that data about releases of radioactive material could be misinterpreted if release reports were received and interpreted by sewage treatment plant personnel rather than radiation safety specialists. Several commenters stated that such an NRC requirement for licensees to provide a 24-hour advance notification was unnecessary because local municipalities have authority over their local sewer district, already have requirements to follow the Clean Water Act, and may establish a pretreatment program for wastewater acceptance. One commenter noted that the usefulness of a 24-hour advance notification should be assessed after the new limits for sewer discharges are in place.

Response: NRC has determined that a requirement for advance notification of each release of radioactive material to a sanitary sewer would impose an unnecessary regulatory burden on licensees without a commensurate health and safety benefit. Additional reasons for the denial of the petition are discussed in the Federal Register notice published on January 27, 2005 (70 FR 3898).

Comment: Six comment letters received in response to the ANPR included comments on the Northeast Ohio Regional Sewer District's request that NRC exempt materials that enter the sanitary waste stream from the requirement for NRC approval prior to treatment or disposal of licensed material by incineration. Four commenters supported such an amendment because, given the radioisotopes and activities involved, the pathways for human exposure from radioactive wastes seem no more or less significant if the wastes are dispersed into water or air. These commenters suggested that, if release into a sanitary sewer system is to be considered disposal, the limits should be set so that no further regulation of the radioactive material is needed after release. One commenter did not support such an amendment and expressed the view that it would only serve to provide an open-ended system for radioactive material to pass into the environment and to the public without limitation or characterization.

Response: NRC approval to incinerating waste is required to ensure that NRC may evaluate the potential impact to the public health and safety and the environment on a case-by-case and site-specific basis. Hazards associated with incineration of sewage sludge will depend on the specific characteristic of the sludge and the radionuclides that may be present. Additional reasons for the denial of the petition are discussed in the Federal Register notice published on January 27, 2005 (70 FR 3898).

The present approach to limiting releases of radioactive material into sanitary sewers is to specify limits on both the monthly average concentration of each radionuclide in a licensee's sewage and the total quantity of radioactive matter that a licensee can release annually. Table 3, Appendix B, of 10 CFR Part 20 lists the allowable monthly average concentration of each radionuclide in a licensee's release to sewers. Allowable concentrations are based upon a calculated dose of 5 mSv/yr (500 mrem/yr) due to ingestion of 2 liters per day of a licensee's effluent into the sanitary sewer.

In the ANPR, NRC invited comments on this regulatory approach. Specifically, NRC invited comment as to whether it should continue to base concentration limits on the assumption that an individual would drink 2 liters of the effluent from a licensee's facility each day, and whether exposure at other locations, such as at a POTW, should be considered in developing release limits. In addition, NRC invited comments about how other exposure scenarios, such as exposure to radionuclides in contaminated sludge, should be accounted for. NRC also invited comments as to whether it should establish limits in terms of dose instead of limits on the quantity and concentrations of radioactive material discharged. Included with the responses to these inquiries were several comments about monitoring, enforcement actions, and regulatory authority to set limits on releases of radioactive material into sanitary sewers that have been addressed with the General Comments.

Comment: Twenty-three commenters supported the current modeling approach of assuming that an individual ingests 2 liters of water taken from the licensee's outfall to the sewer system each day. Nineteen of these commenters, representing hospitals, biomedical laboratories, and universities, noted that this assumption is conservative and easy for licensees to understand. A representative of DOE noted that the approach appears to be bounding, and has been “largely successful as a regulatory measure”. The commenter also expressed the view that, because this type of consumption is not expected to be chronic, it is appropriate to base concentration limits on a calculated annual dose of 500 mrem instead of 100 mrem. One commenter did not specifically address the assumption that an individual would drink 2 liters of a licensee's discharge each day, but did support the use of a licensee's sewer outfall as an appropriate exposure location. Two commenters expressed the view that the modeling assumption was appropriate because individuals, including children, could drink or otherwise be exposed to water directly downstream of a sewer outfall. Another commenter that supported the current assumption expressed the view that modeling exposure at a licensee's outfall to a sewer system is consistent with modeling exposure at a licensee's fence line, as is done in other NRC assessments, and that considering a downstream location would be inconsistent with modeling exposure to the maximally exposed individual.

Response: NRC acknowledges support for the current modeling assumption. The staff notes that several commenters appeared to believe that the concentration limits were based on the assumption that an individual would consume 2 liters of sewage from a POTW outfall, rather than 2 liters of a licensee's effluent into the sewer system, each day. Staff notes that the assumption that an individual would consume a licensee's effluent is more conservative than the assumption that an individual would consume POTW effluent because the concentration of radionuclides in POTW effluent will have been diluted with effluent from all of the other residential and industrial dischargers to the POTW.

Comment: Three commenters expressed concern that the concentration limits are based on an annual dose of 5 mSv (500 mrem) and stated that the concentration limits should be based on an annual dose of no more than 1 mSv (100 mrem), in accord with the 10 CFR 20.1301 limit on doses to members of the general public from licensed activities. One commenter expressed the view that the 1 mSv (100 mrem) annual public dose limit should be lowered. Two commenters expressed the view that the dose from ingesting a licensee's effluent should be included in the 1 mSv (100 mrem) TEDE annual public dose limit rather than being calculated separately and excluded from the 10 CFR 20.1301 limit. Another expressed the view that, if any activity were to be permitted to be discharged into sanitary sewers, the limiting dose for exposure to sewage sludge should be no greater than the dose limit for low level radioactive waste.

Response: NRC acknowledges the commenters' concern about the hypothetical dose used as the basis for the concentration limits. As discussed in the ANPR, the NRC staff believes the concentration limits based on an annual dose of 5 mSv (500 mrem) are reasonable because it is unlikely that an individual would have access to and would consume water at the point at which a licensee discharges water into the sanitary sewer and because dilution from additional discharges into the sewer is likely to reduce the expected dose to well below the 1 mSv (100 mrem) annual dose limit.

NRC also acknowledges the commenters' suggestion that the dose from consuming effluent released into the sanitary sewer be included in the TEDE from other licensee operations. However, in the case of sewer discharge, the point of exposure is expected to be remote from the licensee's facility. Because individuals that could be exposed to a facility's effluent are different individuals than those that live closest to the facility, it would be unrealistic to include the dose from exposure to a licensed facility's effluent in the total dose from all of the facility's activities. The staff notes that comments regarding the appropriate value of the annual dose limit for members of the public from licensed activities specified in 10 CFR 20.1301 are beyond the scope of this rulemaking.

Comment: Ten commenters did not support the use of the current modeling approach of assuming that an individual ingests 2 liters of water taken from a licensee's sewer outfall each day. Almost all of these commenters expressed the view that the assumption is unrealistic. One commenter expressed the view that, while the assumption that an individual ingests 2 liters of water taken from a licensee's sewer outfall each day is a reasonably conservative basis for concentration limits, the assumption may not be a basis for total quantity limits because it would over-emphasize the potential impact of short-lived radionuclides.

Response: NRC acknowledges the commenters' opposition to the current modeling approach. However, it will be retained because the ANPR is being withdrawn for the reasons previously explained. With respect to the comment about the basis for total quantity limits, the staff notes that the assumption that an individual would consume a licensee's effluent is used as the basis of the concentration limits but is not used as the basis of the total quantity limits.

Comment: Ten commenters suggested alternate locations that NRC should consider when developing restrictions on the release radioactive materials into sanitary sewer systems. Of these, five suggested NRC consider the dose to a person ingesting water once it has reached or is leaving a POTW rather than at the licensee's sewer outfall. Three commenters suggested NRC consider locations downstream of a POTW that would be likely to be locations from which a municipality would extract drinking water, while one suggested doses in the nearest residential area should be considered. Another commenter suggested realistic models would incorporate a factor of at least one million between the point of discharge and a receptor locations, and suggested that, if NRC used a more realistic dose model, it would become clear that additional release restrictions are unnecessary. One commenter suggested that, in considering potential doses to members of the public, NRC should consider that sludge could be sent to a landfill, applied to agricultural land, or made into compost for sale to the public.

Five commenters, including representatives of POTWs and DOE, recommended NRC consider doses to sanitation workers and two commenters suggested NRC consider doses to workers that come into contact with sewage collection systems as well as POTW workers. One commenter noted the importance of matching exposure locations to appropriate pathways and suggested external radiation by gamma emitters may be an important pathway for POTW workers, whereas ingestion of beta emitters would be expected to be more important at a downstream drinking water source. Five commenters suggested NRC consider that the careful treatment given to sewage and sludge because of the other hazards it presents should limit doses to sanitary system workers. One commenter added that NRC regulations also should prevent contamination of sewers, POTWs, receiving waters, and sludge and ash disposal sites. Another commenter suggested NRC consider potential exposures to all POTW residuals, including sludge, screenings, grit, and ash. The commenter also pointed out that sewer pipes may leak and suggested NRC consider the potential for groundwater contamination.

Response: The alternate locations that the commenters suggested should be considered in dose models will not be used as a basis for a revision to the regulations because the ANPR is being withdrawn for the reasons previously explained. However, the NRC staff notes that several of the modeling scenarios suggested by the commenters, including sludge handling by POTW workers, sludge incineration, and exposure to land-applied sewage sludge, were considered in the ISCORS dose modeling project (NUREG-1783).

Comment: Six commenters, including representatives of POTWs and the New York State Department of Environmental Conservation, suggested that, in addition to protecting the general public and sanitation workers, NRC regulations should ensure that POTWs can continue to use traditional forms of use or disposal of biosolids (sewage sludge). One commenter noted that events that have not resulted in significant worker exposure have prevented POTWs from using or disposing of sewage sludge.

Response: Additional restrictions on the release of radioactive material into sanitary sewers will not be implemented for the reasons previously discussed. Section 7.2 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B) provides guidance to assist POTW operators in reducing sources of radiation entering their treatment facilities.

Comment: Four commenters made suggestions about ways to account for complex exposure scenarios, such as exposure to contaminated sewage sludge. One commenter suggested that a variety of scenarios should be evaluated and that the scenario resulting in the highest dose should be used to establish limits on releases of radionuclides to sewers. Another commenter expressed the opinion that dose models should reflect limitations on access that are imposed to protect individuals from other health risks associated with sewage and sewage sludge. One commenter suggested no model could adequately represent complex exposure scenarios because dose modeling was not sufficiently well developed.

Response: The approaches the commenters suggested will not be used as a basis for new restrictions on the release of radioactive material into sanitary sewers because the ANPR is being withdrawn for the reasons previously explained. NRC staff acknowledge the commenter's statement about the capabilities of dose modeling.

Comment: Of the fourteen commenters that addressed dose limits, seven supported implementation of dose limits. One commenter expressed the view that dose limits are preferable to limits on concentration and quantity alone because dose limits are easier to relate to risk. The commenter suggested the assumptions used to evaluate compliance with dose limits should be realistic. The commenter also suggested the use of a tiered approach, in which simple bounding assumptions are first used to evaluate compliance, and more complex models and more site-specific data are used only if the simple bounding model does not demonstrate compliance. Another commenter suggested that, if the appropriate models were developed, releases into sanitary sewers should be controlled under the requirements of 10 CFR 20.1302 and ALARA guidelines just as other facility effluents are. The commenter also noted that the potential doses calculated in NUREG/CR-5814 indicate that the current regulations governing the release of radionuclides into sanitary sewers are more restrictive than other NRC dose limits on facility effluents. Two commenters expressed the view that dose limits should be adopted only if the current limits were found not to be protective of the public or POTW workers. Four commenters agreed with the proposal in the ANPR that, if dose limits were adopted, NRC should publish a regulatory guide that included concentration and total quantity guidelines to facilitate compliance. One commenter asked if licensees would have a choice of complying with the dose limit or with the concentration and quantity guidelines published in a Regulatory Guide. Two commenters advocated dose limits, but expressed the view that the dose limits should be based on measured radionuclide concentrations from samples taken from sewer outfalls and intakes or on readings from dosimeters placed at POTWs rather than on concentrations calculated based on assumptions about releases to and dilution in sanitary sewers.

Response: NRC acknowledges the commenters' support for sewer release restrictions to be expressed as limits on dose rather than activity. NRC also acknowledges the commenters' suggestion that compliance with dose limits be made based on sample measurements. However, these options will not be implemented because the ANPR is being withdrawn for the reasons previously explained. No response is required to the commenter's question about compliance with dose limits because the ANPR is being withdrawn.

Comment: Of the fourteen commenters that addressed dose limits, six commenters opposed dose limits, and a representative of the New York State Department of Environmental Conservation noted potential problems with implementing dose limits but suggested NRC study the option. Almost all of the commenters that opposed dose limits commented on the uncertainty of assumptions about exposure pathways and the relative complexity of implementing dose limits as compared to concentration and quantity limits. Three commenters predicted dose limits would require more regulatory oversight because NRC would need to review each licensee's dose model. One commenter expressed the concern that dose limits could make it necessary for licensees to require prior approval for releases of radioactive material into sanitary sewers. One commenter supported the current limits but suggested that, if dose limits were adopted, the dose limit should be 500 mrem/yr, realistic modeling assumptions should be made, and the modeling assumptions to be used in compliance calculations should be clearly defined. Another commenter advocated the use of limits expressed in “verifiable units of measure” rather than limits expressed as dose and expressed doubts about the capabilities of computer models used to calculate dose. Another commenter stated NRC should not limit the dose a patient could receive from a prescribed medical procedure.

Response: NRC acknowledges the commenters' opposition to dose limits, which will not be implemented because the ANPR is being withdrawn.

With respect to the commenter's concern that NRC should not limit the dose a patient could receive due to a medical procedure prescribed by his physician, the NRC staff notes the scope of the ANPR was limited to potential doses due to exposure to radioactive material in sewage or sludge. In general, NRC regulates the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public and does not intrude into medical judgments affecting patients. Additional detail on this topic can be found in NRC's Final Policy Statement on the Medical Use of Byproduct Material, which was published in the Federal Register on August 3, 2000 (70 FR 3898).

Comment: Two commenters expressed concern that NRC would consider setting any non-zero dose limit for POTW workers. Both commenters expressed the view that any dose received by a POTW worker because of exposure to radionuclides released into sanitary sewers by licensees would not be ALARA if the only reason such releases were allowed was to provide an inexpensive method of waste disposal to NRC licensees.

Response: NRC acknowledges the commenters' concern about sanitary system worker doses but disagrees with the view that only a dose of zero could be ALARA. The staff notes that the ISCORS dose modeling report (NUREG-1783) concludes that POTW worker doses typically are very low and are dominated by exposure to NORM. Additional restrictions on the release of radioactive material into sanitary sewers will not be implemented for the reasons previously discussed.

Comment: Three commenters expressed views on the appropriate time period over which releases should be averaged. A representative of a municipality suggested monthly averages should not be used because the practice encourages the use of dilution as a means of meeting the regulations. A representative of AMSA suggested daily averages should be used because POTW workers could be exposed to sewage and sludge on a daily basis. In contrast, a representative of a public utility district supported the use of weekly or monthly averages.

Response: NRC acknowledges the commenters' suggestions about appropriate time periods over which releases should be averaged. NRC believes monthly averages are appropriate because the effects of small quantities of radioactivity released during a month are not expected to depend on the time period over which the radioactive material is discharged. Monthly limits will be retained because the ANPR is being withdrawn for the reasons previously explained.

Comment: Ten commenters supported the development of annual release limits for individual radionuclides or groups of radionuclides. Eight commenters suggested limits for individual radionuclides should be based on the results of dose models. Specific factors that commenters suggested should be included in a dose model included a radionuclide's specific activity, half-life, and solubility, and factors affecting the radionuclide's fate and transport in sewers, wastewater treatment process, and the environment. Two commenters recommended NRC consider imposing different discharge limits for those radionuclides and chemical forms that reconcentrate in POTWs to a significant extent and those that do not. Another commenter suggested NRC set limits for individual radionuclides based on whether they pose a risk primarily due to internal or external exposure and specifically suggested pathway modeling should include exposure to radionuclides that volatilize from sewage at a POTW, exposure to raw river water, and ingestion of treated river water. Another commenter suggested NRC consider the fate of radionuclides in engineered wetlands that are used by some POTWs as a final treatment step. One commenter predicted annual release limits for individual radionuclides would provide more flexibility to licensees and eliminate the need for special licensing exceptions to the current total quantity limits. A representative of DOE predicted that only a very few radionuclides would require reduced quantity limits even if the limits were conservative to bound variations in sewage plant designs and operating characteristics and to account for potential improvements in waste water treatment technology.

Four commenters suggested that annual release limits should be based on radionuclide half-life. A representative of the Texas Department of Health predicted it may be difficult for licensees to keep track of the quantity of each radionuclide released and suggested NRC impose one quantity limit for short-lived radionuclides that would be unlikely to reconcentrate in sewage sludge and a lower limit for long-lived radionuclides that have a greater potential to reconcentrate in sewage sludge.

A representative of the New York State Department of Environmental Conservation noted that it may not be appropriate to use Annual Limit of Intake (ALI) values as a basis for annual release limits for individual radionuclides, as suggested in the ANPR, because the ingestion pathway may not be the most significant exposure pathway and because the chemical form of a radionuclide may be significantly different when it is released from a POTW than it was when it was originally discharged to the sewer. One commenter suggested both the total quantity of all radionuclides as well as quantities of individual radionuclides released should be limited, and that quantity limits for individual radionuclides should be based on fractions, rather than multiples, of ALI values. The commenter also suggested annual limits should assure the lowest possible rather than the lowest “reasonably achievable” exposure of members of the public to radionuclides.

Response: NRC acknowledges the commenters' support for the development of annual release limits for individual radionuclides or groups of radiounuclides. However, the proposed change will not be made because the ANPR is being withdrawn for the reasons previously explained.

Comment: Five commenters opposed the development of annual release limits for individual radionuclides. Two commenters suggested the low calculated doses received in the case studies discussed in the ANPR indicate the current regulations are adequate. Two commenters suggested that, if NRC were to change the annual quantity limits, it should focus on Co-60, Sr-90, Cs-137, Ir-192, and Am-241, because these radionuclides were identified in NUREG/CR-5814 as having the potential to result in a significant dose, based on the pre-1991 release limits. A representative of the State of Illinois Department of Nuclear Safety recommended NRC change the total quantity limits only if the releases of Co-60, Sr-90, Cs-137, Ir-192, and Am-241 that were determined to be potentially problematic in NUREG/CR-5814 would still be permitted, given the restrictions on form and lower concentration limits introduced in the 1991 revision to 10 CFR part 20.

Another commenter noted that, although limiting the quantities of radionuclides released would not necessarily be difficult, the need to analyze batches of wastewater to determine the quantities of individual radionuclides being released would be a significant burden as compared to the current method the company uses, which is to base releases on DOT shipping papers that identify the most limiting radionuclide in a batch. However, the commenter also noted that using limits based on multiples of ALI would be “on the right track” and would be similar to methods used in Europe.

One commenter expressed the view that the biokinetics of individual radionuclides could not be modeled well enough to provide a basis for limits on the quantity, concentration, or form in which a radionuclide could be discharged, especially because the models would not include the synergistic effects of radiation and other pollutants. The commenter also expressed the view that the exempt quantities published in 10 CFR Part 30 represented quantities “below regulatory concern” (BRC) and suggested it would be inappropriate to use multiples of the exempt quantity values as annual quantity limits.

Response: NRC acknowledges the commenters' opposition to annual release limits for individual radionuclides, which supports withdrawal of the ANPR.

The fourth topic on which NRC invited comment was the exemption of patient excreta from the regulations governing releases of radioactive material into sanitary sewers. NRC received fifty-two letters that addressed the exemption for patient excreta.

Comment: Forty-four commenters, including a representative of AMSA, recommended the exemption for patient excreta be continued and suggested it required no additional evaluation. Thirty-three of the commenters stated the exemption is necessary to maintain doses ALARA. Several commenters predicted that the radiological risks to health care workers, in the case of hospitalized patients, or family members, in the case of patients released from the hospital, associated with managing excreta would be far greater than any risk that the excreta would pose to POTW workers or members of the general public once released to the sewer system. Several commenters noted the possibility that excreta could be spilled or inadequately shielded, especially in the case of patients that had been released from the hospital. One commenter expressed concern about radioactive materials volatilizing from containers of urine. Another commenter noted that children or pregnant women could be subject to increased risk from excreta stored in the home if the exemption were withdrawn. Seven commenters noted that, in addition to the radiological risks, collection and storage of patient excreta also could pose biological hazards.

Twenty-seven of the commenters that supported the exemption noted the short half life of most radiopharmaceuticals, and most of these commenters hypothesized that the risk that radiopharmaceuticals could pose to sanitary system workers or members of the general public would be limited by their short half lives. Representatives of two hospitals indicated that approximately 90 percent of the radioactivity used at their hospitals was in the form of Tc-99m, which has a half life of 6 hours, and that most of the remaining radionuclides used have a half-life on the order of a few days. Twenty commenters noted the soluble or dispersible nature of patient excreta and five commenters suggested the dilution of patient excreta that occurs in the sewer system affords ample protection to the public and to the environment.

Four commenters remarked that, if NRC believes the regulation is adequate, as stated in the ANPR, there should not be a need to modify the exemption for patient excreta. Two commenters predicted restrictions on the release of patient excreta into sanitary sewers would not provide a significant benefit to public health and eleven commenters suggested the current exemption creates no environmental or public health hazard. One commenter remarked that none of the six case studies presented in the ANPR indicated that patient excreta released into sanitary sewers had caused a significant dose to any individual. A representative of a large health care organization noted that no complaints had been made about the sewage from any of the organization's hospitals, although the hospitals' effluents were tested by sanitary system staff routinely. Another hospital representative expressed the opinion that hospitals should not be required to monitor patient excreta because the practice causes undue anxiety in the patients, creates additional burdens for nursing staff, and is unnecessary because survey readings generally are low.

Response: NRC acknowledges the commenters' support for the exemption for patient excreta, which supports the withdrawal of the ANPR.

Comment: Fourteen commenters stated that elimination of the exemption would impose significant burdens on their facilities' operations. Commenters expressed concern about the costs of building holding tanks for excreta, building separate plumbing systems, retraining workers, and employing additional workers to manage patient excreta. One commenter remarked that facilities would also incur the cost of hiring professionals to assess their current waste management practices and to recommend changes that would be needed to comply with new regulations. Three commenters remarked that medical facilities may also incur the costs of increased NRC licensing fees and inspections. Several commenters suggested any net health benefits associated with eliminating the exemption could not justify the costs of controlling the excreta, particularly for patients being treated on an out-patient basis.

Seven commenters predicted the costs of compliance with restrictions on release of patient excreta into sanitary sewers would cause a significant increase in health care costs for patients. Three commenters predicted that health care costs would increase both because of the increased infrastructure and labor required to manage patient excreta and because patients' hospital stays would be extended so that their excreta could be managed by hospital staff. A physician and member of the NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI) estimated that the national increase in health care costs would be approximately 4.5 billion dollars for patients undergoing therapeutic procedures and 62 billion dollars for patients undergoing diagnostic procedures, as of 1994. The American College of Nuclear Physicians and the Society of Nuclear Medicine jointly estimated that elimination of the exemption would cause an increase in health care costs of 5.9 billion dollars annually.

One commenter expressed the concern that medical facilities may stop offering nuclear medicine services to avoid the legal consequences that could result if patients did not comply with restrictions on the release of excreta to sewer systems. Five commenters predicted that it would be difficult to compel patients being treated on an out-patient basis to store their excreta for decay or return it to a licensed facility. One commenter expressed the concern that strict controls over patients could infringe upon a patient's constitutional rights.

Several commenters expressed the concern that elimination of the exemption would impact patient care. Four commenters expressed the opinion that, if the exemption were eliminated, the costs or logistical difficulties associated with managing patient excreta would cause many facilities to discontinue offering nuclear medicine services and could cause the end of nuclear medicine in the United States. Three commenters expressed the concern that elimination of the exemption for patient excreta would limit patient access to diagnostic and therapeutic nuclear medicine services and five commenters expressed the view that inaccessibility of nuclear medicine services would be far more detrimental to public health than any adverse health effects that could be averted by eliminating the exemption for patient excreta. One commenter noted that many facilities already have eliminated some clinical procedures because of the lack of access to low level radioactive waste disposal facilities. Two commenters expressed the concern that eliminating the exemption for patient excreta would diminish the quality of care that patients received if facilities limited patient doses to comply with restrictions on the radioactivity of patient excreta released into sanitary sewers. One commenter expressed the concern that patients may decline beneficial medical procedures because of an objection to collecting or having someone else collect their excreta. One commenter noted that patient well-being would be compromised if patients needed to remain in the hospital so that their excreta could be managed because it would prolong the time away from their families and jobs. Another commenter suggested the current exemption for patient excreta should be maintained until the impact on health care could be assessed.

Response: NRC acknowledges the commenters' concerns about the potential costs, legal implications, and impacts on patient care that may be caused by removing the exemption for patient excreta. The exemption will be maintained because the ANPR is being withdrawn for the reasons previously explained.

Comment: Three commenters suggested the effects of the exemption should be studied to determine if the exemption should be eliminated or modified. A representative of DOE recommended NRC maintain the exemption for the excreta of patients undergoing diagnostic procedures, but consider placing restrictions on the excreta of patients undergoing therapeutic procedures because they typically receive higher doses of radiopharmaceuticals. Another commenter remarked that it would be inconsistent of NRC to impose strict restrictions on the release of excreta by hospitalized patients if the excreta of patients being treated on an out-patient basis contributed more radioactivity to sanitary sewer systems. A representative of an association of POTWs in Minnesota stated that the organization is prepared to rely on NRC judgement about the appropriateness of the exemption once NRC has evaluated the amounts and types of radioactive materials released into sanitary sewers through patient excreta, but expressed concern that the ANPR indicated that the effects of the exemption had not been studied and would not be included in planned modeling efforts. The commenter also expressed the opinion that the safety of the exemption should be evaluated irrespective of the origin of the waste in medical uses. A representative of the New York State Department of Environmental Conservation suggested that a range of possibilities, including retaining the exemption, eliminating the exemption, and modifying the exemption, should be evaluated in an Environmental Impact Statement (EIS). The commenter stated an EIS would provide a “long-needed” record of the rationale for the decision to exempt patient excreta from the sewer release restrictions and the expected impacts of the exemption on the environment and public health.

Response: NRC acknowledges the suggested modifications to the exemption of patient excreta and the suggestion that an EIS should be performed. However, those suggestions will not be implemented because the ANPR is being withdrawn for the reasons previously explained.

Comment: Two commenters suggested releases of radioactive materials into sanitary sewers should be regulated uniformly, irrespective of the origin of the wastes. One of the commenters questioned why the ANPR specifically stated that doses from patient excreta were expected to be “far below the NRC's dose limit” when this description was equally appropriate for the discharges from other licensees. Another commenter remarked that, although it may be difficult for medical institutions to meet restrictions on the release of patient excreta, the releases should be regulated because they have been shown to contaminate sewage sludge. Another commenter provided measurements of I-131 in sewage and sludge in one municipality's POTW and expressed the concern that I-131 could be a source of radiation exposure to sanitary system workers. The commenter also expressed the concern that, although it has a short half life, Tc-99m could cause significant radiation doses to workers exposed to sewage collection systems directly downstream of hospitals. In addition, the commenter expressed the concern that, because I-131 is very soluble, most of the I-131 that entered a POTW would be discharged in the treated effluent and that the POTW's effluent may, therefore, exceed NRC limits on the allowable releases of radioactivity to unrestricted areas. The commenter also expressed concern that many municipalities are not aware that releases of patient excreta are exempt from NRC restrictions and can be a significant source of radioactivity in wastewater.

Response: NRC acknowledges the commenters' suggestion that the release of radioactive material should be regulated uniformly irrespective of its origin. However, NRC believes the exemption for patient excreta is appropriate because of the potential biological and radiological hazards associated with alternate methods of managing patient excreta. Additional limitations on the release of patient excreta into sanitary sewers are not being imposed for the reasons previously discussed. NRC appreciates the commenter's concern that municipalities may be unaware of the potential for patient excreta to contribute to the radioactivity of wastewater and sewage sludge. Section 3.2 of the ISCORS recommendations on managing radioactive material in sewage sludge and ash (EPA 832-R-03-002B) alerts POTW operators that a significant amount of the radioactivity discharged to POTWs that serve medical facilities can be discharged in the form of patient excreta.

Comment: Two commenters suggested the exemption for patient excreta should be eliminated to minimize the release of man-made radioactivity to the environment. One commenter expressed concern about NRC's policy on allowing patients who had received nuclear medicine treatments to leave the hospital (described in NRC Information Notice 94-009). The commenter also expressed concern about specific incidents in which, the commenter believed, patients had not been warned that high residual radioactivity would result from the medical procedures they had undergone or had been told that releasing excreta to a septic system would not cause adverse health effects. The commenter remarked that, although the radionuclides used in nuclear medicine procedures may be short-lived, each contribution of radioactivity to wastewater increased the potential dose to a member of the public. Another commenter noted that the contribution of radiopharmaceuticals to the radioactivity of wastewater increases as the number of procedures performed increases. The commenter also remarked that, if the half-lives of radioisotopes used in medical procedures typically are short, as NRC stated in the ANPR, the burden of storing the excreta until the radioactivity decays to background levels should not be large.

Response: NRC acknowledges the commenters' concerns about the potential effects of the release of patient excreta into sanitary sewers. However, NRC believes the current regulations are protective and has decided to retain the exemption and withdraw the ANPR for the reasons previously explained. The staff notes that comments about the regulations governing the release of nuclear medicine patients from the hospital are beyond the scope of this rulemaking.

Comment: One commenter suggested patient “vomitus” should be included in the exemption for the release of patient excreta into sanitary sewers explicitly. Two additional commenters mentioned sweat, saliva, blood, tears, and nasal fluids, but did not make any specific suggestions about how those fluids should be addressed in NRC regulations.

Response: The suggested change to the wording of the exemption will not be made because the ANPR is being withdrawn. However, NRC staff note that, in practice, the term “patient excreta” typically is understood to include situations when patients vomit.

Comment: A representative of a company that manufactures equipment that removes radionuclides from hospital waste noted German law requires that radioactive materials be removed from hospital effluent before it is released into sanitary sewers.

Response: NRC appreciates the information provided by the commenter. However, the exemption for patient excreta will be retained because the ANPR is being withdrawn for the reasons previously explained.

Comment: Three commenters asked questions about the regulatory implications of potential modifications to the exemption of patient excreta from sewer release restrictions. Two commenters asked whether patients would be required to store their excreta at home until it decayed to background levels of radioactivity or if they would be required to return it to the medical facility at which they were treated. Two commenters asked whether the homes of nuclear medicine patients would need to be monitored to ensure that proper waste disposal procedures had been followed. One commenter asked if the elimination of the exemption would result in changes to 10 CFR 35.75. The commenter also asked whether restrictions would apply to all patients treated with radiopharmaceuticals, irrespective of the dose they had received. The commenter also asked how a licensee would calculate the radioactivity released by each patient and whether records of the releases would need to be maintained by the licensee.

Response: NRC acknowledges the many questions on this issue, but is not responding to them because the ANPR is being withdrawn.

Comment: One commenter suggested NRC should exempt the excreta of animals used in biomedical research from the restrictions governing the release of radioactive material into sanitary sewers.

Response: NRC notes that this comment is beyond the scope of this rulemaking.

In addition to comments on the topics discussed in the ANPR, NRC received a number of comments on other aspects of the release of radioactive material into sanitary sewers. These comments are addressed in this section.

Comment: Sixteen commenters expressed the opinion that the current regulations governing the release of radioactive materials into sanitary sewers are adequate and should not be changed. To support this view, commenters remarked that the number of incidents of contamination is small compared to the number of POTWs receiving radioactive materials and that the doses received in those instances are believed to be low. Commenters also suggested the regulations should not be changed in response to a small number of cases of contamination, especially if some of those cases involved violations of the applicable regulations. One commenter noted that modeling results described in NUREG/CR-5814 indicate that releases of radionuclides used in biomedical research are expected to result in doses below the ALARA guidelines in NRC Regulatory Guide 8.37. A representative of the Texas Department of Health suggested the regulations should not be changed unless modeling results demonstrated that exposures other than ingestion could cause an annual dose greater than 5 mSv (500 mrem). Two commenters suggested the risk of adverse health effects associated with exposure to radioactive material released into sanitary sewers should be evaluated in comparison to the health risks associated with exposure to hazardous chemical and biological materials in sewage and sludge. One commenter suggested the current limits are appropriate because the quantities and concentrations of radionuclides at affected POTWs appear to be within 10 CFR part 30 limits for general licensees.

Response: NRC acknowledges the commenters' support for the current regulations, which supports withdrawal of the ANPR.

Comment: Nine commenters, including a representative of DOE, suggested the changes made to 10 CFR part 20 in 1991 may have significantly reduced the potential for reconcentration of radionuclides in POTWs, and that resources should not be expended to address a problem that may have already been solved. Of these, five commenters noted that the ANPR did not include any information about contamination problems that had occurred since the modification of 10 CFR part 20 and two commenters noted that most of the contaminants in the case studies presented in the ANPR were insoluble non-biological materials and would not meet current release criteria. Several commenters recommended NRC evaluate the effects of the lower discharge concentration limits and prohibition against discharging insoluble, non-biological materials into sanitary sewers before making additional changes to 10 CFR part 20. One commenter expressed the opposite view and stated that the NRC should not assume that the changes made to 10 CFR part 20 in 1991 would eliminate contamination of POTWs with licensed radioactive materials.

Response: NRC acknowledges the commenters' recommendation that it study the effect of the changes made to 10 CFR part 20 in 1991 on the amount of radioactive material at POTWs. The NRC staff notes that the ISCORS sewage sludge survey and dose modeling work were performed several years after the January 1, 1993, deadline for licensees to meet the revised requirements and should reflect the effects of the 1991 revision of the regulation.

Comment: Five commenters expressed the view that additional restrictions on the release of radioactive materials into sanitary sewers would not be consistent with efforts to keep doses ALARA. Several of the commenters predicted that doses to workers that were required to collect or prepare waste for disposal would be far greater than the collective dose that could be averted by more restrictive sewer release limits.

Response: NRC acknowledges the commenters' opposition to additional restrictions on the release of radioactive materials into sanitary sewers, which supports the withdrawal of the ANPR.

Comment: Four commenters stated that any additional restrictions on the release of radioactive material into sanitary sewers would have a significant negative impact on the facilities they represented. One commenter expressed the view that banning the release of radioactive material into sewers would impose a large financial burden on all biological research facilities and estimated that, as of 1994, alternative disposal methods would cost his company $150,000 to $300,000 annually. A representative of a nuclear laundry stated that additional restrictions on the release of radioactive material into sanitary sewers could have a serious detrimental effect on his company and its customers in nuclear laundries could no longer operate. Another commenter suggested new restrictions should be implemented gradually by adding new restrictions during license renewals.

One commenter expressed concern that additional restrictions on the release of radioactive material to sewers would encumber facilities that perform medical research, and requested that educational and medical research institutions be exempted from the regulations because the long-lived radionuclides that had been detected in the cases described in the ANPR typically are not used by medical research facilities. The commenter also requested that, if medical research facilities were not exempted, more explicit guidance about the implications of the regulations on specific practices used in medical research facilities be provided by NRC. Another commenter proposed that the regulation should explicitly permit disposal of medical diagnostic products in aqueous mixtures that contain less than 370 kBq (10 microcuries) of radioactivity and which are composed of isotopes with half-lives less than 61 days.

Response: NRC acknowledges the commenters' information about the burdens that could be caused by additional restrictions on the release of patient excreta into sanitary sewers, which supports the withdrawal of the ANPR. The staff notes that requests for exemptions of certain classes of facilities or types of waste are beyond the scope of this rulemaking. NRC acknowledges that guidance written specifically for medical research facilities would be helpful to some licensees, but does not have plans or resources to develop such guidance.

Comment: A representative of DOE expressed the view that the current rules are protective of public heath and safety and the environment, and noted that, if the provision for release of radioactive materials into sanitary sewers was not available, risks to the public would result from other waste management options. As an example, the commenter predicted elimination of the release of radioactive material into sewers would cause an increase in traffic accidents because of the need to transport more waste to LLW disposal facilities. However, the commenter also recommended NRC increase inspections of licensees' releases into sanitary sewers and perform additional analyses of potential doses to members of the public and sanitary system workers to ensure that adequate safety provisions are in place to preclude accidental discharge of large quantities of radioactive material. The commenter also recommended NRC contact AMSA and industry trade groups to obtain additional information about variations and trends in wastewater treatment technologies, practices, and regulations.

Response: NRC acknowledges the commenter's remarks regarding the risks that could result from additional restrictions on the release of radioactive material into sanitary sewers, which support the withdrawal of the ANPR. In accord with the commenter's suggestions, NRC participated in the ISCORS sewage sludge survey (NUREG-1775) and dose modeling report (NUREG-1783), the results of which provide a technical basis for withdrawing the ANPR. The staff acknowledges the suggestion regarding NRC inspection activities but notes the topic is beyond the scope of this rulemaking.

Comment: A representative of NIH stated that, although NIH is a large facility conducting both biomedical research and medical diagnosis and treatment, and its usage of some isotopes fluctuates considerably, NIH has been able to manage its radioactive liquid wastes in compliance with NRC regulations. The commenter also stated that NIH uses large, centrally-located tanks to hold short-lived radionuclides for decay, and that NIH has been granted an exception to the total quantity limits that allows it to discharge a total of 296 GBq (8 Ci)

Response: NRC acknowledges the commenter's information regarding the adequacy of the current regulations governing the release of radioactive material into sanitary sewers.

Comment: A commenter who was a member of ACMUI as well as a physician and professor of Radiological Sciences at the University of California, Los Angeles, expressed several concerns regarding the possible changes described in the ANPR. The commenter expressed the opinion that NRC resources would be better spent changing other parts of 10 CFR part 20 than by making the changes proposed in the ANPR. The commenter also stated that Agreement States had been reluctant to adopt the changes made to 10 CFR part 20 in 1991 because of unspecified problems with the revised rule. The commenter expressed concern that user fees were used to support a National Council on Radiation Protection study of the number of various types of nuclear medicine procedures performed annually as of 1989. The commenter also expressed concern that any change in NRC regulations governing the release of radioactive materials into sewers would later be changed by an EPA rule, and that NRC licensees would, in effect, pay for a rule twice by paying both NRC user fees and paying taxes to support EPA.

The commenter asked why the NRC had published the ANPR and expressed concern that NRC wasted licensees' time by asking for data regarding various nuclear medicine procedures. The commenter stated that the data had been given to NRC in 1990 and asked why NRC did not use these data to derive concentrations of various radionuclides in sanitary sewage. The commenter also suggested NRC could request data regarding concentrations of radioactive materials in wastewater and sewage sludge from POTWs in Agreement States. In addition, the commenter suggested NRC review any proposed changes related to medical uses of isotopes with the ACMUI and expressed an unfavorable opinion about NRC's program to regulate medical uses of radionuclides.

Response: NRC acknowledges the commenter's statements about the 1991 revision to 10 CFR part 20 but notes that other parts of the regulation are beyond the scope of this rulemaking. A response to the commenter's displeasure at paying licensing fees to support this rulemaking is not needed because the ANPR is being withdrawn. The same applies to the commenter's concern that EPA would impact a change in NRC's regulations. Because the ANPR is being withdrawn, that concern is no longer applicable to this issue.

NRC published the ANPR to invite comments and recommendations from interested parties on potential changes in the regulations governing the release of radioactive materials into sanitary sewers. In response to the commenter's concern about the time licensees may have spent responding to the ANPR, NRC notes that the ANPR invited comment but did not require a response. In addition, NRC notes that the ANPR invited comment on a variety of issues and was not limited to a request for information to support the derivation of concentrations of radionuclides in sewage.

NRC acknowledges the commenter's suggestion that potential changes to the rule be discussed with the ACMUI, and the commenter's statements about NRC's program to regulate medical uses of radionuclides.

Comment: Three commenters expressed the view that cases of contamination at POTWs demonstrate that the current regulations governing the release of radioactive material into sanitary sewers is inadequate. All three commenters expressed the concern that the regulations did not adequately protect the health and safety of POTW workers. In addition, a representative of AMSA expressed the concern that the current regulations could jeopardize the ability of POTWs to fulfill their environmental objectives. The commenter also expressed concern about NRC's involvement with existing cases of contamination and urged NRC to take a more active role in protecting POTWs from contamination with radionuclides.

Each of the three commenters expressed the opinion that the current regulations also fail to protect POTWs from the legal and financial consequences of contamination of POTWs and POTW biosolids with radionuclides. Two commenters noted that the public ultimately bears the costs associated with contamination of POTWs and one estimated that billions of dollars of public funds could be required to dispose of contaminated sludge and decontaminate POTWs. A representative of the City of Oak Ridge outlined the history of contamination of the Oak Ridge POTW with Co-60, Cs-137, uranium isotopes, and I-131 from 1984 to 1994. The commenter noted that, as of 1994, disposal of wastewater treatment sludge cost the City of Oak Ridge approximately $100,000 per year, primarily because of radioactive contamination. The commenter stated that, because of this expense, the city is in the process of implementing its own limits to control releases of radioactive materials into the sanitary sewers and provided a reference that describes the approach that has been taken to control radioactive materials through the municipality's industrial pretreatment program.

A representative of the Northeast Ohio Regional Sewer District noted that, although no significant health or safety problems had been found to result from the contamination at the district's Southerly Facility, the district has had to manage difficult regulatory issues and concerns from the public and from workers that had cost the district, as of 1994, $1.5 million to resolve. The commenter remarked that the sanitary district had over one hundred thousand cubic meters (4 million cubic feet) of Co-60 contaminated ash at its Southerly Facility and had recently discovered contamination at another one of its POTWs. The commenter expressed the view that the District's problems were attributable to inadequate regulations or ineffective enforcement by NRC and suggested that major revisions to both 10 CFR part 20 and to NRC's enforcement program were overdue.

Response: NRC acknowledges the commenters' concerns about cases of contamination and protection of POTW workers. However, NRC believes that the restrictions on the forms of material suitable for release and lower concentration limits established in the 1991 revision to 10 CFR part 20 have reduced the potential for significant contamination of POTWs or sewage sludge with radionuclides. Although additional restrictions on the release of radioactive material into sanitary sewers will not be implemented, Section 7.2 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B) provides guidance to assist POTW operators in reducing sources of radiation entering their treatment facilities. Comments about NRC's enforcement program are beyond the scope of this rulemaking.

NRC acknowledges the information provided by the City of Oak Ridge regarding the POTW's industrial pretreatment program. Information about the program is summarized in Appendix F of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B).

Comment: A representative of a sanitary district stated that, contrary to the position taken by NRC in the ANPR, many cases of contamination of POTWs are the result of relatively basic wastewater treatment technologies. In addition, the commenter expressed the view that NRC's emphasis on the concept of “reconcentration” as the cause of contamination problems is misleading and noted that, at one POTW in the district, it appeared that particles of Co-60 were removed from the sewage through settling, as other solids are removed, rather than through reconcentration of dissolved cobalt or agglomeration of fine particles. The commenter expressed the view that the new restrictions on the forms of materials suitable for release into sanitary sewers may prevent many problems with insoluble materials such as Co-60 if the regulations are properly enforced.

Response: NRC acknowledges the commenter's concern that the term “reconcentration” was used in the ANPR to describe all processes by which the concentration of radionuclides in sewage sludge or ash could be increased on volumetric basis. NRC understands that radioactive materials may be concentrated by common wastewater treatment processes, as discussed in NUREG/CR-6289.

Comment: Seven commenters expressed the view that discharges of radioactive materials into sanitary sewers should be regulated locally. Two commenters suggested that, because relatively few cases of contamination had been observed, it appeared that the cases could be resolved without NRC involvement. One commenter expressed the view that local control would be easiest to implement if the problematic discharges involved other hazardous, nonradioactive materials.

Five commenters, including a representative of AMSA, expressed the opinion that POTWs should have the legal authority to establish local limits for the release of radioactive material into sanitary sewers. Three of the commenters expressed the concern that, although municipalities are held responsible for the disposal or beneficial use of POTW sludge, the municipalities have no control over the radioactivity of materials discharged to the sewer system that affect sludge quality. One commenter expressed the concern that the existing regulatory framework is inadequate because NRC maintains that the party in possession of the radioactive material is responsible for remediation, offers no assistance to POTWs that have been contaminated by a licensee's effluent, and states that the AEA indicates that its regulations preempt more restrictive local regulations. The commenter expressed concern that NRC has indicated that this position would not change even if NRC had proof that material was illegally discharged by a licensee and that a POTW's only recourse to recover remediation costs is to take legal action against the discharger. One of the commenters suggested NRC should either assume responsibility for disposing of radioactive sludge generated in POTWs as a result of “errant discharge” from NRC licensees or allow POTWs to regulate the discharge of radioactive materials into sewer systems. The other commenter suggested that, in cases in which the reuse or disposal of sludge is restricted because of its radiological contamination, NRC should cooperate with EPA to help affected POTWs establish local discharge limits to protect the traditional method of disposal or reuse of the biosolids.

Another commenter stated that it was not necessary, feasible, or appropriate for NRC to develop new regulations that would limit the disposal of radioactive material into sanitary sewers because POTWs already had the legal authority and mandate to establish and enforce appropriate pretreatment standards that would prevent contamination of POTWs or sewage sludge, pursuant to the Clean Water Act (33 U.S.C. 1317(b) and (d) and 1319) and EPA Clean Water Act Standards (40 CFR Part 403).

Response: NRC acknowledges the commenters' concern about the power that local authorities have to regulate the release of radioactive material to their POTWs. The U.S. Supreme Court has held that, for certain activities covered by the AEA, Federal authority preempts other regulatory authorities whose purpose is radiation protection. It is difficult to predict whether unusual cost to the POTW caused by radioactive effluent discharges would be a sufficient reason to impose more restrictive discharge limits than those permitted under Federal law because there are no Federal cases in which the specific facts corresponded to the scenarios faced by local POTW authorities. More information on this issue is presented in Chapter 4 and Section 7.2 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B).

Comments regarding NRC's responsibility for the disposal of contaminated sludge are beyond the scope of this rulemaking. As discussed in Chapter 7 of the ISCORS recommendations (EPA 832-R-03-002B), in individual cases of contamination, legal counsel should be consulted to determine if dischargers may be liable for portions of remediation costs.

Comment: One commenter recommended NRC exempt POTWs from any regulations that would apply to material released into their systems because the potential benefits of regulating POTWs would not justify the costs.

Response: This suggestion is beyond the scope of this rulemaking.

Comment: Five commenters, including a representative of AMSA, expressed the view that POTWs should be able to apply the same type of pretreatment standards to radionuclides in licensees' effluent that are applied to toxic materials discharged into sewer systems by industrial dischargers as part of EPA's NPDES program. Commenters noted that local limits can account for the number of licensees discharging to a single POTW, the total flow into a POTW, and the effects of various treatment process on radionuclide reconcentration. Three commenters noted that, in general, local restrictions on discharges of pollutants to POTWs are established by determining an allowable load of a pollutant to a POTW that will not create a violation of the POTW's effluent limit and not interfere with disposal or reuse of the POTW's biosolids, and then allocating that limit among industrial facilities that discharge effluent to the POTW. Two commenters expressed the view that the same process should be used to develop individual limits for each radionuclide, taking into account each radionuclide's specific activity, half-life, and solubility. One commenter noted that this procedure cannot be followed with radioactive materials because no “acceptable” levels of radionuclides in sludge have been established. Another commenter recommended NRC coordinate any future regulations affecting sanitary sewer discharges with EPA requirements for Clean Water Act discharges, including Categorical Standards, NPDES permits, and regulations pertaining to sewage sludges.

Two commenters suggested that, because setting limits for radioactive materials will be new to many POTWs, NRC should provide guidance on establishing local limits on the release of radioactive materials into sanitary sewers. A representative of AMSA suggested a number of topics that the recommended guidance should address and recommended NRC consider two EPA resources used to develop limits on industrial discharges to POTWs.

Response: This comment includes detailed recommendations about the creation of a program in which the release of radionuclides into sanitary sewers would be regulated by local, rather than Federal, authorities, and is beyond the scope of this rulemaking. Although guidelines for the development of local limits under such a program have not been developed, many of the topics the commenters requested be included in such guidance are included in the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B), as is information about local pretreatment programs established in Albuquerque, NM, St. Louis, MO, and Oak Ridge, TN.

Comment: One commenter was concerned that system-specific discharge limits could be difficult to implement if, as is done in the NPDES process, discharge limits are based on the “waste assimilative capacity” of the receiving waterway, which, the commenter stated, could be difficult to determine. The commenter also expressed concern that licensees would need to obtain prior approval for sewer discharges, and that regulatory agencies would need to keep track of separate discharge allotments for each licensee and any changes to each POTW's treatment processes. The commenter noted that an alternative to establishing system-specific discharge limits would be to set activity limits so low that regulatory limits or ALARA goals for public doses would be met, irrespective of the wastewater treatment process used, the capacity of the receiving POTW, or the number of dischargers discharging to the POTW. The commenter noted that this approach would not require as much regulatory oversight and suggested these approaches should be evaluated in an EIS.

Response: NRC acknowledges the commenter's concerns about the difficulties involved with implementing system-specific discharge limits. An EIS that evaluates the alternatives will not be developed because the ANPR is being withdrawn for the reasons previously discussed.

Comment: One commenter asked for clarification as to how the revised rule would relate to NRC decommissioning standards and various EPA rules and suggested NRC hold public hearings on the issue.

Response: NRC is not responding to the request for clarification on the relationship between the proposed rule and EPA or NRC standards because the ANPR is being withdrawn.

Comment: Ten commenters expressed the view that any change to the regulations governing the release of radioactive materials into sanitary sewers should have a solid technical basis. Three commenters recommended NRC delay decisions about the need for modifications to the regulation until NUREG/CR-6289, which was incomplete at the time, was made available to licensees. Two commenters expressed concern that the ANPR was offered without a significant risk assessment. Six commenters recommended that any proposed change in the regulation should be based on a realistic assessment of either the collective dose or the risks to members of the public and POTW workers that the new regulations would avert. Two commenters expressed the concern that changes to the regulations would be made for reasons other than technical reasons, including regulatory convenience, a perception of public opinion, or political pressure.

A representative of the New York State Department of Labor remarked that some of the regulatory changes proposed in the ANPR would be complex for both licensees and regulatory agencies to implement and, therefore, should not be undertaken without a without a firm technical basis. The commenter expressed the view that, except for the exemption of patient excreta, all of the options discussed in the ANPR required more analysis before NRC would have sufficient information on which to base a decision. The commenter expressed the opinion that frequent changes in the same regulation are especially burdensome for licensees and urged NRC to perform the necessary analyses before changing the rule again. Representatives of the New York State Energy Office and New York State Department of Environmental Conservation encouraged NRC to develop an EIS to evaluate the options discussed in the ANPR. The representative of the New York State Department of Environmental Conservation remarked that the current regulations, including the revisions made in 1991, had never undergone a full environmental review.

Two commenters expressed the concern that the current limits on the discharge of radioactive material to sewers do not reflect the hazards radioactive materials could pose in a POTW or after release to the environment. The commenters recommended NRC initiate a study that would include a POTW hazard identification and assessment, exposure and toxicity assessments, and a risk characterization. The two commenters also recommended NRC study the fate and transport of radionuclides in sewers, POTWs, and the environment. A representative of the City of Oak Ridge provided a reference that discussed the fate and transport of radionuclides in the municipality's POTW. A representative of AMSA recommended NRC cooperate with EPA, POTWs, and affected industries to assess the exposure and contamination pathways of radionuclides, and the impact of radioactive materials on wastewater treatment processes.

Response: NRC acknowledges the commenters' view that the 1991 revision to the regulations governing the release of radioactive materials into sanitary sewers should have been based upon detailed risk analyses. As discussed previously, NRC cooperated with representatives of EPA and POTWs in developing the ISCORS survey and dose modeling project to assess the radioactive contamination in POTWs and pathways for exposure of POTW workers and members of the general public to radionuclides released into sanitary sewers. The results of these analyses served as the technical basis for the withdrawal of the ANPR. An EIS for the rulemaking will not be performed because the ANPR is being withdrawn for the reasons previously discussed.

Comment: Three commenters, including a representative of AMSA, recommended NRC study the extent of the use of sewer discharges and contamination of POTWs around the country. The representative of AMSA suggested that, because NRC had acknowledged that it did not know how many POTWs in the country were contaminated with radionuclides and because it would be inappropriate to develop national standards based on contamination in a few isolated cases, NRC should establish a task force composed of NRC and EPA staff as well as representatives of POTWs and licensees to study the nature and extent of radioactive contamination of POTWs nationally. Three commenters recommended NRC determine which licensees release radioactive material into sanitary sewers and two of these commenters recommended NRC make the information available in a national database. Of these commenters, one suggested the database should be similar to the EPA's Toxic Release Inventory and the other suggested the database should include information about the mass of each radionuclide discharged per year by each licensee, the volume of the licensee's discharge, and the licensee's POTW service area. A representative of one utility district expressed concern that, as of 1994, the NRC had not been able to provide a list of the licensees discharging into the district's sewer system and that the district had, therefore, been unable to initiate an appropriate monitoring program.

Response: NRC acknowledges the commenters' request for a national database, but notes that a database that contains information about releases of radioactive material into sanitary sewers by licensees is not being developed. As discussed in Section 5.1 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B), POTW operators are encouraged to contact the applicable NRC Regional Office, appropriate State Radiation Safety Office, and any nearby DOE facilities if they have questions about the sewer releases of facilities in the POTW's service area that use radioactive materials.

Comment: One commenter requested that, because NRC had just begun to study the fate of radionuclides in POTWs and because NRC did not know which of its licensees discharged materials into sanitary sewers, a moratorium be imposed on the disposal of radioactive material into sanitary sewers until NRC had the information necessary to help POTWs develop protective limits.

Response: NRC notes that this comment is beyond the scope of this rulemaking.

Comment: One commenter expressed concern that the assumptions used in 10 CFR part 20 ignored exposures to children, fetuses, elderly, people with existing body burdens of radioactive material, and individuals in other sensitive groups. The commenter expressed concern that the risk of birth defects from ionizing radiation had been limited to only two generations in NRC analyses and stated that the greatest number of birth defects will be seen in generations beyond the next two. The commenter also expressed the view that NRC should consider non-cancer and nonfatal cancer health effects in risk calculations and expressed concern that these effects were not considered in the promulgation of 10 CFR part 20.

Response: The commenter's remarks about NRC's development of standards for the protection against radiation are beyond the scope of this rulemaking.

Comment: Three commenters recommended NRC perform a cost/benefit analysis of alternatives to the release of radioactive materials into sanitary sewers before proceeding with a rulemaking and two of those commenters expressed the view that the proposed changes could not be justified by either a risk analysis or cost/benefit analysis. One commenter urged NRC to apply the backfit provisions that apply to power reactors to a broader scope of rulemaking decisions, and expressed the view that the alternatives suggested in the ANPR could not be justified in a backfit analysis.

Response: NRC is not performing a cost/benefit analysis or risk analysis because the ANPR is being withdrawn for the reasons previously discussed. The staff note that the commenter's opinions about NRC's backfit provisions are beyond the scope of this rulemaking.

Comment: One commenter expressed the concern that limits based on overly-simplified dose models could be overly-restrictive and could cause unintended harm to the public by limiting beneficial uses of radioactive materials. The commenter suggested NRC consider the “total societal impact” of its release limits, and expressed the view that NRC and other regulatory agencies typically perform inadequate assessments of the financial impacts of their rules. The commenter added that NRC should not avoid this responsibility by claiming that the AEA does not give it the responsibility to evaluate the total societal impact of its rules, because evaluation of cost, benefit, and total societal impact is inherently included in the concept of maintaining doses ALARA.

Response: NRC acknowledges the commenter's concern about the adequacy of financial impact analyses performed by NRC and other regulatory agencies. NRC staff agree that, as defined in 10 CFR 20.1003, the term “ALARA” indicates consideration of societal and socioeconomic impacts.

Comment: Five commenters expressed the opinion that, in general, any changes to the regulations should allow less radioactive material to be released into sanitary sewers. Reasons for this position included new information about the adverse effects of chronic exposure to low levels of ionizing radiation, information about the synergistic effects of radiation and chemical pollutants, and concern about the cumulative effects of multiple sources of radiation on public health and the environment. Two commenters suggested that all radioactive waste should be isolated in secure storage or disposal facilities. Another commenter stated that NRC should not allow environmental build-up of multiple sources of radiation even if each, individually, could be dismissed as being minimal. One commenter stated that his organization had commented on the revision of 10 CFR part 20 repeatedly and that it remains concerned that the allowable concentrations of many radionuclides in air and water increase.

Response: The ANPR is being withdrawn for the reasons previously explained. Comments about the basis for NRC's standards for the protection against radiation are beyond the scope of this rulemaking.

Comment: Four commenters expressed the opinion that the potential burden that additional restrictions on the release of radioactive material into sanitary sewers would impose on licensees is secondary to the primary goal of protecting public health and safety and should be given little weight in the evaluation of whether additional restrictions should be established. Two commenters expressed concern that, in the ANPR, NRC made several inquiries about the impacts of new restrictions on licensees without expressing a similar interest in the potential impacts of the release of radioactive material into sanitary sewers on other parties. One of the commenters expressed the view that the concern for licensees may be misplaced because it is municipalities, and not licensees, that ultimately bear the costs of disposal of contaminated sludge and POTW decontamination. The commenter also remarked that it appeared to be more appropriate for licensees, rather than the public, to bear the expense of the disposal of radioactive materials used by licensees. The other commenter suggested NRC should have solicited comments regarding the potential impact of the regulations on public health, healthcare costs, contamination of agricultural land, restriction of land uses, and environmental degradation. Two commenters stated that it would be inappropriate for NRC to allow any risk to members of the public to lessen economic or regulatory burden on licensees. Another commenter noted that, in cases in which contamination of a POTW has been discovered, licensees must recognize that safety of the community is more important than the desire for a licensee to use its current disposal options.

Response: NRC acknowledges the commenters' concerns regarding the specific requests for comment in the ANPR. With regard to the consideration given to the potential effects of changes in the regulation on public health and the environment as compared to potential burdens on licensees, the NRC staff notes that a significant effort was made to study the potential effects of the release of radioactive material into sanitary sewers on the public and POTW workers in conjunction with the ISCORS reports that were described previously. Comments about the basis for NRC's standards for the protection against radiation are beyond the scope of this rulemaking.

Comment: Six commenters suggested that detection of radionuclides at a few POTWs is an insufficient reason to impose additional restrictions on the release of radioactive material to sanitary sewers. These commenters stated that radioactivity can be measured at very low levels that are not expected to cause a significant adverse health effect for any individual. One commenter stated that lowering release limits to values that are significantly lower than limits needed to protect the public makes it more difficult for licensees to assure compliance of medical research and clinical staff with radiation safety procedures and undermines the public's confidence in realistic exposure or activity standards. Another commenter recommended NRC acknowledge that the risks caused by radioactivity in sewage sludge are small compared to the risks associated with the extra handling and transportation of waste that would occur if releases of radioactive material to sanitary sewers were eliminated.

One commenter also suggested that, because radioactivity can exist in sewer systems and POTWs without causing a significant dose to any individual, and because there are beneficial uses of radioactive materials, that it might be better to attempt to build public acceptance of the current practices than it would be to lower release limits or eliminate sewer discharge. Another commenter suggested incidents of contamination should be handled in a consistent, routine way without undue alarm. A representative of DOE predicted that any discovery of radioactive contamination of sewage pipes or sewage treatment plants is likely to result in regulatory concern, even if the possible doses are tiny, because it may take time to determine whether the contamination poses a threat to public health and safety.

Response: NRC acknowledges the commenters' opinions, which support the withdrawal of the ANPR. The staff acknowledges the commenters' recommendations about proper treatment of cases of contamination, but notes they are beyond the scope of this rulemaking.

Comment: Three commenters addressed the potential for accidental releases of radioactive material into sanitary sewers. One commenter hypothesized that the case studies presented in the ANPR may have been the result of abnormal events and expressed the opinion that no amount of regulation, planning or notification can prevent inadvertent releases that result from system failures or other errors. Another commenter suggested NRC should realize that, irrespective of its regulations, an individual is likely to find a way to defeat “reasonable safeguards.” Another commenter expressed concern that the modeling results described in the ANPR did not account for the potential for accidental releases in excess of the 10 CFR part 20 limits and suggested the reported calculated doses may be underestimates.

Response: NRC acknowledges the commenters' statements about the possibility of accidental releases. NRC staff note that its inspections are designed to ensure licensees' operations are conducted safely and in accordance with good practices and license conditions. With respect to the commenter's concern that the dose modeling results discussed in the ANPR do not include the effects of accidental releases, NRC staff note that the doses estimated in NUREG/CR-1548 did not include the potential effects of accidental releases; however, the doses reported in the ISCORS dose modeling report (NUREG-1783) were based on observed levels of radioactivity measured in conjunction with the ISCORS sewage sludge survey (NUREG-1775) and, therefore, reflect any accidental releases that may have been made to the 313 POTWs surveyed.

Comment: Seven commenters addressed LLW disposal. Four commenters noted that additional restrictions on the release of radioactive materials to sewers would increase the amount of low level radioactive waste that would need to be disposed of in some other way. Two commenters recommended NRC evaluate the options proposed in the ANPR in the context of the risks associated with the disposal of low level nuclear waste and the limited capacity of LLW disposal facilities. Two commenters noted that many licensees had, as of 1994, very limited or no access to LLW disposal facilities and one of the commenters noted that licensees without access to a LLW disposal facility would need to store waste on site indefinitely. Three commenters noted that additional restrictions on the release of radioactive materials into sanitary sewers would be especially burdensome because the facilities they represented lacked access to LLW disposal sites. One commenter stated that sewer disposal is the primary way that many medical research and biotechnology laboratories minimize generation of LLW.

One commenter expressed the concern that the use of sanitary sewer disposal of radioactive material would increase because of the high cost and limited availability of LLW disposal. The commenter noted that the release of radioactive material into sanitary sewers itself can lead to the creation of large volumes of LLW by contaminating sludge. Another commenter opposed the implication that sanitary sewer disposals would be used as a means of relief from the relative inaccessibility of LLW disposal and noted that most types of LLW do not meet the requirements for release into sanitary sewers.

Response: NRC acknowledges the commenters' concerns regarding the impact that the proposed changes would have because of some licensees' lack of access to LLW disposal facilities. These comments support the withdrawal of the ANPR.

NRC also acknowledges the commenter's concern that limitations on LLW disposal could lead to an increase in the release of radioactive material to sanitary sewers. The NRC staff notes that the results of the ISCORS sewage sludge survey (NUREG/CR-1775) do not indicate that the frequency of POTW contamination incidents has increased since the commenters' remarks were made in 1994.

Comment: Five commenters expressed the opinion that licensees should bear all costs associated with waste disposal. One commenter suggested NRC's descriptions of case studies should include a description of the financial costs associated with the contamination and should indicate the party paying the remediation costs. Two commenters stated that NRC licensees should bear the costs of data collection, data reporting, and worker training needed to implement any new NRC studies or regulations needed to protect POTWs from contamination. Two commenters expressed the view that licensees should pay to have monitoring equipment installed at POTWs.

Response: NRC acknowledges the commenter's suggestion that NRC's descriptions of case studies should include information about the economic aspects of the contamination and notes that some information about remediation costs is provided in Section 1.2 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B). Comments regarding the costs associated with implementation of new sewer release restrictions are moot because the ANPR is being withdrawn.

Comment: Six commenters expressed opinions about NRC enforcement actions. A representative of DOE stated that it was unclear whether one or more of the incidents described in the ANPR involved violations of the regulations, and suggested enhanced inspections, and not additional rulemaking, would be the most appropriate way to eliminate contamination of POTWs. Three commenters suggested NRC or POTWs should verify licensee's reported discharges into sanitary sewers and one commenter suggested compliance with NRC regulations should be demonstrated at the licensee's outfall into the sanitary sewer system so that POTWs would not be impacted and would not need to implement special controls. Two representatives of POTWs noted that POTWs routinely sample the effluent of major industrial users as part of their industrial pretreatment programs. Another commenter suggested NRC should assist POTWs with monitoring of licensee's effluents and enforcement of the discharge limits.

Response: NRC notes that suggestions about inspection and enforcement activities are beyond the scope of this rulemaking.

Comment: Six commenters made specific suggestions about monitoring. Two commenters suggested licensees' outfalls and potable water intakes should be monitored, and three commenters suggested monitoring also should occur at POTWs. One of the commenters that advocated monitoring at POTWs expressed the view that monitoring would limit uncertainty in model results and would facilitate the study of the effects of influent radionuclide form and quantity on POTW worker doses. The commenter also suggested licensees should be encouraged to provide dosimetry and elementary radiation safety training to POTW workers. One commenter expressed the opinion that radionuclides in licensees' effluents should be monitored to record the highest concentrations discharged and facilitate a regulator's ability to link discharges with their sources. Three commenters suggested the radioactivity of sewage sludge should be monitored. One commenter expressed concern about the radioactivity of an engineered wetland used to treat wastewater in his town.

Response: Recommendations regarding locations for monitoring a licensee's effluent are beyond the scope of the proposed rulemaking.

Comment: A representative of the New York State Department of Environmental Conservation recommended that the Notice of Proposed Rulemaking for any change to the regulation governing the release of radioactive material into sanitary sewers notice, for public comment, the compatibility category NRC intends to apply to each provision so that Agreement States and other interested parties can participate in decisions about compatibility requirements. The commenter stated that, as of 1994, Agreement States were required to develop regulations that were compatible with the revised 10 CFR part 20 without NRC having determined compatibility requirements and stated that this type of situation must not recur.

Response: NRC acknowledges the commenter's recommendation that intended compatibility categories be included in Notices of Proposed Rulemaking. Compatibility categories for the options discussed in the ANPR are moot because the ANPR is being withdrawn.

Comment: One commenter expressed a number of concerns about the case studies described in the ANPR. Concerns raised by the commenter included specific exposure pathways that may not have been included in the dose analyses, the appropriateness of NRC's comparison of doses with background radiation, and the concern that calculated doses to individuals could have been higher if the sludge to which they were exposed included radiation from multiple sources. The commenter expressed the view that radioactivity in the environment may increase because of human activity, and that it would be inappropriate to consider manmade contributions of radioactivity to the environment in the calculation of “background” radiation, or to allow releases because they would be minimal in comparison to background radiation. The commenter also remarked that the cases of contamination that had occurred in Washington, DC, and Cleveland, OH, indicated the potential for contamination to be significant to large populations. In addition, the commenter asked specific questions about the assumptions used to calculate the doses resulting from the case studies discussed in the ANPR and what sources of radiation NRC included in its calculation of “background radiation.”

Response: The commenter's concerns about the doses calculated in the case studies are no longer applicable because more recent studies served as the technical basis for the withdrawal of the ANPR. NRC acknowledges the commenter's concern regarding contamination at POTWs. The commenter's specific questions about the modeling assumptions used to calculate doses for the case studies discussed in the ANPR are addressed in NUREG/CR-1548. NRC notes that its definition of “background radiation,” provided in 10 CFR 20.1003, excludes contributions of radioactivity from source, byproduct, or special nuclear materials regulated by NRC.

The U.S. Small Business Administration (SBA) has received requests from firms in the Security Guards and Patrol Services Industry (referred to as the Security Guards Industry) to review the current $10.5 million size standard. This size standard was last revised in 2002 to incorporate an inflation adjustment to receipt-based size standards (67 FR 3041, January 23, 2002). These firms believe that a size standard increase is warranted due to the increased costs of complying with Federal agency requirements for security guards, increased number of large security firms competing for Federal contracts, and the relative success by large firms in winning Federal contracts. These firms also believe that these industry trends would shrink the pool of eligible small businesses causing Federal agencies to scale back their use of small business preferences in Federal procurement. Below is a discussion of the methodology used by SBA to review its size standards, and the analysis leading to the proposal to increase the Security Guards Industry's size standard to $15.5 million.

Size Standards Methodology: Congress granted SBA discretion to establish detailed size standards (15 U.S.C. 632(a)(2)). SBA's Standard Operating Procedure (SOP) 90 01 3, “Size Determination Program” (available on SBA's web site at http://www.sba.gov/library/soproom.html ) describes four factors for establishing and evaluating size standards: (1) The structure of the industry and its various economic characteristics; (2) SBA program objectives and the impact of different size standards on these programs; (3) whether a size standard successfully excludes those businesses which are dominant in the industry; and (4) other factors if applicable. Other factors, including the impact on other Federal agencies' programs, may come to the attention of SBA during the public comment period or from SBA's own research on the industry. No formula or weighting has been adopted so that the factors may be evaluated in the context of a specific industry. Below is a discussion of SBA's analysis of the economic characteristics of an industry, the impact of a size standard on SBA programs, and the evaluation of whether a firm at or below a size standard could be considered dominant in the industry under review.

Industry Analysis: Section 3(a)(3) of the Small Business Act (15 U.S.C. 632 (a)(3)), requires that size standards vary by industry to the extent necessary to reflect differing industry characteristics. SBA has two “base” or “anchor” size standards that apply to most industries—500 employees for manufacturing industries and $6 million in average annual receipts for nonmanufacturing industries. SBA established 500 employees as the anchor size standard for the manufacturing industries at SBA's inception in 1953 and shortly thereafter established a $1 million average annual receipts size standard for the nonmanufacturing industries. The receipts-based anchor size standard for the nonmanufacturing industries has been adjusted periodically for inflation so that, currently, the anchor size standard is $6 million. Anchor size standards are presumed to be appropriate for an industry unless its characteristics indicate that larger firms have a much greater significance within that industry than the “typical industry.”

When evaluating a size standard, the characteristics of the specific industry under review are compared to the characteristics of a group of industries, referred to as a “comparison group.” A comparison group is a large number of industries grouped together to represent the typical industry. It can be comprised of all industries, all manufacturing industries, all industries with receipt-based size standards, or some other logical grouping.

If the characteristics of a specific industry are similar to the average characteristics of the comparison group, then the anchor size standard is considered appropriate for the industry. If the specific industry's characteristics are significantly different from the characteristics of the comparison group, a size standard higher or, in rare cases, lower than the anchor size standard may be considered appropriate. The larger the differences between the specific industry's characteristics and the comparison group's characteristics, the larger the difference between the appropriate industry size standard and the anchor size standard. SBA will consider adopting a size standard below the anchor size standard only when (1) all or most of the industry characteristics are significantly smaller than the average characteristics of the comparison group, or (2) other industry considerations strongly suggest that the anchor size standard would be an unreasonably high size standard for the industry under review.

The primary evaluation factors that SBA considers in analyzing the structural characteristics of an industry include average firm size, distribution of firms by size, start-up costs, and industry competition (13 CFR 121.102(a) and (b)). SBA also examines the possible impact of a size standard revision on SBA's programs as an evaluation factor. SBA generally considers these five factors to be the most important evaluation factors in establishing or revising a size standard for an industry. However, it will also consider and evaluate other information that it believes relevant to the decision on a size standard for a particular industry. Public comments submitted on proposed size standards are also an important source of additional information that SBA closely reviews before making a final decision on a size standard. Below is a brief description of each of the five evaluation factors.

1. “Average firm size” is simply total industry receipts (or number of employees) divided by the number of firms in the industry. If the average firm size of an industry is significantly higher than the average firm size of a comparison industry group, this fact would be viewed as supporting a size standard higher than the anchor size standard. Conversely, if the industry's average firm size is similar to or significantly lower than that of the comparison industry group, it would be a basis to adopt the anchor size standard or, in rare cases a lower size standard.

2. “Distribution of firms by size” is the proportion of industry receipts, employment, or other economic activity accounted for by firms of different sizes in an industry. If the preponderance of an industry's economic activity attributed by smaller firms, this tends to support adopting the anchor size standard. A size standard higher than the anchor size standard is supported for an industry in which the distribution of firms indicates that economic activity is concentrated among the largest firms in an industry.

In this proposed rule, SBA examines the percent of total industry sales cumulatively generated by firms up to a certain level of sales. For example, assume for the industry under review that 30 percent of total industry sales are generated by firms of less than $10 million in sales. This statistic is compared to a comparison group. For the nonmanufacturer anchor comparison group (used in this proposed rule), firms of less than $10 million in sales cumulatively generated 49.4 percent of total industry sales. Viewed in isolation, the lower figure for the industry under review indicates the presence of larger-sized firms in this industry than firms in the industries in the nonmanufacturing anchor size standards comparison group and, therefore, a higher size standard may be warranted.

3. “Start-up costs” affect a firm's initial size because entrants into an industry must have sufficient capital to start and maintain a viable business. To the extent that firms entering into one industry have greater financial requirements than firms do in other industries, SBA is justified in considering a higher size standard. In lieu of direct data on start-up costs, SBA uses a proxy measure to assess the financial burden for entry-level firms. For this analysis, SBA has calculated average firm assets within an industry. Data from the Risk Management Association's Annual Statement Studies, 2000-2001, provide average sales to total assets ratios. These were applied to the average receipts size of firm in an industry to estimate average firm assets. An industry with a significantly higher level of average firm assets than that of the comparison group is likely to have higher start-up costs, which would tend to support a size standard higher than the anchor size standard. Conversely, if the industry showed a significantly lower level of average firm assets when compared to the comparison group, the anchor size standard would be considered the appropriate size standard, or in rare cases a lower size standard.

4. “Industry competition” is assessed by measuring the proportion or share of industry receipts obtained by firms that are among the largest firms in an industry. In this proposed rule, SBA compares the proportion of industry receipts generated by the four largest firms in the industry—generally referred to as the “four-firm concentration ratio”—to the average four-firm concentration ratio for industries in the comparison groups. If a significant proportion of economic activity within the industry is concentrated among a few relatively large producers, SBA tends to set a size standard relatively higher than the anchor size standard in order to assist firms in a broader size range to compete with firms that are larger and more dominant in the industry. In general, however, SBA does not consider this to be an important factor in assessing a size standard if the four-firm concentration ratio falls below 40 percent for an industry under review.

5. “Impact of a size standard revision on SBA programs” refers to the possible impact a size standard change may have on the level of small business assistance. This assessment most often focuses on the proportion or share of Federal contract dollars awarded to small businesses in the industry in question. In general, the lower the share of Federal contract dollars awarded to small businesses in an industry which receives significant Federal contracting revenues, the greater is the justification for a size standard higher than the existing one.

Another factor to evaluate the impact of a proposed size standard on SBA's programs is the volume of guaranteed loans within an industry and the size of firms obtaining those loans. This factor is sometimes examined to assess whether the current size standard may be restricting the level of financial assistance to firms in that industry. If small businesses receive significant amounts of assistance through these programs, or if the financial assistance is provided mainly to small businesses much lower than the size standard, a change to the size standard (especially if it is already above the anchor size standard) may not be necessary.

Evaluation of Industry Size Standard: The two tables below show the industry structure characteristics for the Security Guards Industry and for two comparison groups. The first comparison group is comprised of all industries with a $6 million receipts-based size standard referred to as the nonmanufacturing anchor group. Since SBA's size standards analysis is assessing whether the Security Guards Industry's size standard should be moderately higher, or much higher than the nonmanufacturing anchor size standard, this is the most logical set of industries to group together for the industry analysis. In addition, this group includes a sufficient number of firms to afford a meaningful assessment and comparison of industry characteristics. The second comparison group consists of the nonmanufacturing industries with the highest receipt-based size standards established by SBA. SBA refers to this comparison group as the “nonmanufacturing higher-level size standard group.” This group's size standards range from $21 million to $30 million. If an industry's characteristics are significantly larger than those of the nonmanufacturing anchor group, SBA will compare them to the characteristics of the higher-level size standards group. By doing so, SBA can assess whether a size standard should be among the highest size standards or somewhere between the anchor size standard and the highest size standards.

For its analysis, SBA examined 2002 industry data prepared for SBA's Office of Advocacy by the U.S. Bureau of the Census ( http://www.sba.gov/advo/research/us_rec02.txt ), data from a U.S. Bureau of the Census report “Investigation and Security Services: 2002”, (Report EC02-561-06), and data from the Risk Management Association's Annual Statement Studies, 2000-2001. SBA also examined Federal contract award data for fiscal years 2002-2004 from the U.S. General Service Administration's Federal Procurement Data Center, and SBA's internal loan database on SBA guaranteed loans during fiscal year 2004.

Security Guards Industry Structure Considerations: Table 1 shows data on three evaluation factors for the Security Guards Industry and the two comparison groups. These factors are average firm size, average firm assets, and the four-firm concentration ratio.

For the Security Guards Industry, its average firm size in receipts is more than twice that of the average firm size in the nonmanufacturer anchor group, but significantly lower than the average firm size in the higher-level size standards group. This factor indicates a size standard within a range of $13 to $15 million may be appropriate, which is slightly more than double the $6 million anchor size standard. The average firm assets factor is below the nonmanufacturing anchor group and does not provide a basis for increasing the current size standard. The four-firm concentration ratio provides some support for a change to the current size standard. While the factor is appreciably higher than the average industry in the two comparison groups, it is not at a sufficient level to suggest that larger firms in the industry could control the industry through pricing or other forms of collaboration nor that a very substantial increase to the size standard should be considered. In relation to the higher-level size standards group, the four-firm concentration ratio suggests a standard higher than $10.5 million is reasonable. The level of the size standard, however, should be based on the consideration of the other evaluation factors.

Table 2 below examines the size distribution of firms. For this factor, SBA evaluates the percent of total sales cumulatively generated by firms at or below specific receipts sizes. For example, firms in the Security Guards Industry with $10 million or less in receipts cumulatively obtained 27.1 percent of total industry sales. Within the nonmanufacturing anchor group, these size firms captured 49.4 percent of total industry sales while similar firms in the higher-level size standards group captured 21.1 percent.

The distribution of sales for the Security Guards Industry show the presence of larger-sized firms than in the nonmanufacturer anchor group, but not as large as those in the higher-level size standards group. The data for the less than $1 million and less than $5 million size classes support a size standard well above the anchor size standard, but below the higher-level size standards ranges. The other two size classes, less than $10 million and less than $50 million, support a size standard at or near the higher-level size standards range. Considering the overall distributions across size classes, an appropriate size standard appears to be near, but below, the higher-level size standards group, such as between $18 million to $20 million.

SBA Program Considerations: SBA also considers the potential impact of changing a size standard on its programs. Because SBA's review of the Security Guards Industry's size standard was prompted by concerns about the application of the size standard to Federal contracting, SBA examines the pattern of Federal contract awards to small businesses as one of the factors in evaluating whether the size standard should be revised. The findings provide mixed support for a change to the current size standard.

Small businesses in the Security Guards Industry received 37.2 percent of the total dollar value of Federal contracts awarded during fiscal years (FY) 2003 and 2004. This share is moderately higher than the 28 percent of sales cumulative generated by firms at or below the current $10.5 million size standard. This performance indicates that small businesses as currently defined have not encountered substantial difficulties in obtaining Federal contracts, and does not provide a basis for revising the size standard.

SBA also evaluated specific contract data available for FY 2002 and 2003 to assess the concern that Federal contracts may be concentrated among a few firms. The data revealed some degree of concentration may exist. Between 400 and 500 businesses received security guard contracts in those two years. In FY 2002, three businesses captured two-thirds of the dollar value of Federal security guard contracts. However, in FY 2003, the top three large businesses obtained only 38 percent. Only one large business was among the top three contractors in both years. These contracting patterns indicate that one large business is the top contractor for Federal security guard contracts, but both large and small businesses have many opportunities. As with the assessment of the factor of industry concentration discussed above, the distribution of Federal contracts suggests that a standard higher than $10.5 million is a reasonable change, but does not provide a basis to significantly depart from the level indicated by the analysis of the industry evaluation factors.

SBA also reviewed data on its financial assistance to small businesses in this industry. In FY 2003 and 2004, SBA guaranteed an average of 75 loans for $10.8 million in the Security Guards Industry. Ninety percent of these loans were made to firms less than half the current size standard. It is unlikely that an increase to the size standard would have an appreciable impact on the financial programs, and therefore, this factor is not part of the assessment of this industry's size standard.

SBA Proposal: Based on the analysis of each evaluation factor, SBA is proposing a $15.5 million size standard—a $5 million increase (47 percent) to the current size standard. Three of the five evaluation factors support a size standard higher than the current $10.5 million size standard, while the other two factors support no change. SBA believes the presence of large-sized firms in the industry, as depicted by the factors of average size firm, the distribution of firms by size, and four-firm concentration ratio, is sufficiently strong to support a moderate change to the current size standard. The proposed size standard represents an average of the lower range of potential size standards indicated by the average firm size and size distribution factors.

Dominant in Field of Operation: Section 3(a) of the Small Business Act defines a small concern as one that is (1) independently owned and operated, (2) not dominant in its field of operations and (3) within detailed definitions or size standards established by the SBA Administrator. SBA considers as part of its evaluation of a size standard whether a business concern at or below a size standard would be considered dominant in its field of operation. This assessment generally considers the market share of firms at the proposed or final size standard, or other factors that may show whether a firm can exercise a major controlling influence on a national basis in which significant numbers of business concerns are engaged.

SBA has determined that no firm at or below the proposed size standard for the Security Guards Industry would be of a sufficient size to dominate its field of operation. The largest firm at the size standard level generates less than 0.11 percent of total industry receipts. This level of market share effectively precludes any ability for a firm at or below the proposed size standard from exerting a controlling effect on this industry.

Alternative Size Standards: SBA considered an alternative size standard based on average number of employees instead of average annual receipts. This approach was considered in a proposed rule of March 19, 2004 (69 FR 13130) as part of restructuring of size standards. Because of the large proportion of part-time employees in this industry, SBA has decided to retain average annual receipts as the size standard measure. A receipts-based size standard treats firms more equitably because firms vary on the use of part-time employees and subcontractors. An employee size standard could unintentionally influence decisions of some firms to alter the use of part-time employees and subcontractors to retain their status as small businesses.

SBA welcomes public comments on its size standard for the Security Guards Industry. Comments on alternatives, including the option of retaining the size standard at $10.5 million or establishing an employee-based size standards as discussed above, should explain why the alternative would be preferable to the proposed size standard.

The Office of Management and Budget (OMB) has determined that this proposed rule is not a “significant” regulatory action for purposes of Executive Order 12866. For the purpose of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, SBA has determined that this rule would not impose new reporting or recordkeeping requirements, other than those required of SBA. For purposes of Executive Order 13132, SBA has determined that this rule does not have any Federalism implications warranting the preparation of a federalism assessment. For purposes of Executive Order 12988, SBA has determined that this rule is drafted, to the extent practicable, in accordance with the standards set forth in that Order.

Under the Regulatory Flexibility Act (RFA), this rule, if finalized, may have a significant impact on a substantial number of small entities engaged in the Security Guards Industry. As described above, this rule may impact small entities seeking SBA (7a) and 504 Guaranteed Loan Programs, its Economic Impact Disaster Loans, and SBA and other Federal small business procurement preference programs. Newly defined small businesses would benefit from SBA's 7(a) and 504 Guaranteed Loan Programs. SBA estimates that one or two additional loans totaling $1 million or less in new Federal loan guarantees could be made to these newly defined small businesses. Because of the size of the loan guarantees, most loans are made to small businesses well below the size standard. Thus, increasing the size standard will likely result in only a small increase in small business guaranteed loans to businesses in this industry, and the $1 million estimate may overstate the actual impact. These additional loan guarantees, because of their limited magnitude, will have virtually no impact on the overall availability of loans for SBA's loan programs, which have averaged about 88,000 loans totaling more than $17 billion in fiscal year 2004.

The size standard may also affect small businesses participating in programs of other agencies that use SBA size standards. As a practical matter, however, SBA cannot estimate the impact of a size standard change on each and every Federal program that uses its size standards. Immediately below, SBA sets forth an initial regulatory flexibility analysis (IRFA) of this proposed rule on the Security Guards Industry addressing the following questions: (1) What is the need for and objective of the rule, (2) what is SBA's description and estimate of the number of small entities to which the rule will apply, (3) what is the projected reporting, recordkeeping, and other compliance requirements of the rule, (4) what are the relevant Federal rules which may duplicate, overlap or conflict with the rule and (5) what alternatives will allow the Agency to accomplish its regulatory objectives while minimizing the impact on small entities?

The revision to the size standard for the Security Guards Industry more appropriately defines the size of businesses in this industry that SBA believes should be eligible for Federal small business assistance programs. SBA reviewed the structure of this industry using five factors that were compared with averages for two groups of industries. A review of the latest available data supports a change to the current size standard.

SBA estimates that 50 additional firms out of 4,853 firms in this industry would be considered small as a result of this rule, if adopted. The firms would be eligible to seek available SBA assistance provided that they meet other program requirements. Firms becoming eligible for SBA assistance as a result of this rule, if finalized, cumulatively generate $790 million in this industry out of a total of $13.6 billion in annual receipts. The small business coverage in this industry would increase by 5.8 percent of total receipts. Also, SBA estimates that approximately 100 small businesses that are within 20 percent of the existing size standard could grow and retain their small business status if this proposed rule were adopted.

A new size standard does not impose any additional reporting, recordkeeping or compliance requirements on small entities. Increasing size standards expands access to SBA programs that assist small businesses, but does not impose a regulatory burden as they neither regulate nor control business behavior.

This proposed rule overlaps with other Federal rules that use SBA's size standards to define a small business. Under § 3(a)(2)(C) of the Small Business Act, 15 U.S.C. 632(a)(2)(c), unless specifically authorized by statute, Federal agencies must use SBA's size standards to define a small business. In 1995, SBA published in the Federal Register a list of statutory and regulatory size standards that identified the application of SBA's size standards as well as other size standards used by Federal agencies (60 FR 57988-57991, dated November 24, 1995). SBA is not aware of any Federal rule that would duplicate or conflict with establishing size standards.

Other Federal agencies also may use SBA size standards for a variety of regulatory and program purposes. If such a case exists where an SBA size standard is not appropriate, an agency may establish its own size standards with the approval of the SBA Administrator (see 13 CFR 121.902-903). For purposes of a regulatory flexibility analysis, agencies must consult with SBA's Office of Advocacy when developing different size standards for their programs (13 CFR 121.902(b)(4)).

SBA considered an alternative size standard based on average number of employees instead of average annual receipts. It also considered a range of size standards as part of the assessment of each evaluations factor. Because of the large proportion of part-time employees in this industry, an employee size standard could unintentionally influence decisions of some firms to alter the use of part-time employees and subcontractors to remain as small businesses. SBA believes that a moderate increase to the size standard will assist businesses that should be included as small businesses and small businesses that are growing. In selecting the proposed size standard, currently defined small businesses will not be competitively disadvantaged as compared to a much higher size standard.

SBA welcomes comments on other alternatives that minimize the impact of this rule on small businesses and achieve the objectives of this rule. These comments should describe the alternative and explain why it is preferable to this proposed rule.

For the reasons set forth in the preamble, SBA proposes to amend part 13 CFR Part 121 as follows.

1. The authority citation for part 121 continues to read as follows:

2. In § 121.201, in the table “Small Business Size Standards by NAICS Industry,” under the heading “Subsector 561—Administrative and Support Services,” revise the entry for 561612 to read as follows:

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also review the docket using the Internet at the web address in the ADDRESSES section.

Privacy Act: Using the search function of our docket Web site, anyone can find and read the comments received into any of our dockets, including the name of the individual sending the comment (or signing the comment on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78) or you may visit http://dms.dot.gov.

Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

If you want the FAA to acknowledge receipt of your comments on this proposal, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it to you.

Do not file in the docket information that you consider to be proprietary or confidential business information. Send or deliver this information directly to the person identified in the FOR FURTHER INFORMATION CONTACT section of this document. You must mark the information that you consider proprietary or confidential. If you send the information on a disk or CD ROM, mark the outside of the disk or CD ROM and also identify electronically within the disk or CD ROM the specific information that is proprietary or confidential.

Under 14 CFR 11.35(b), when we are aware of proprietary information filed with a comment, we do not place it in the docket. We hold it in a separate file to which the public does not have access, and place a note in the docket that we have received it. If we receive a request to examine or copy this information, we treat it as any other request under the Freedom of Information Act (5 U.S.C. 552). We process such a request under the DOT procedures found in 49 CFR part 7.

You can get an electronic copy using the Internet by:

(1) Searching the Department of Transportation's electronic Docket Management System (DMS) Web page ( http://dms.dot.gov/search );

(2) Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or

(3) Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.

You can also get a copy by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680. Make sure to identify the docket number, notice number, or amendment number of this rulemaking.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart III, section 44701(a)(5). Under that section the FAA is charged to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce. Additionally, § 44704(a)(3) specifically mandates that a “person may manufacture a new aircraft, aircraft engine, propeller, or appliance based on a type certificate (TC) only if such other person is the holder of the type certificate or has permission from the holder.” Paragraph (a)(4) of that section includes a limitation for aircraft manufactured before August 5, 2004 and states that “paragraph (3) shall not apply to a person who began the manufacture of an aircraft before August 5, 2004, and who demonstrates to the satisfaction of the Administrator that such manufacture began before August 5, 2004.” That paragraph further states that “a person is permitted to invoke this exception with regard to the manufacture of one aircraft.” By prescribing requirements for manufacturers of new aircraft, this proposed regulation is within the scope of the Administrator's general authority and fulfills the statutory mandate set forth in § 44704(a).

On February 15, 2005, the FAA published in the Federal Register a proposal that, among other things, would incorporate into our regulations requirements contained in laws recently passed by Congress. See 70 FR 7829. One portion of the proposal would incorporate a provision enacted as part of Vision 100—Century of Aviation Reauthorization Act of 2003 (Pub. L. 108-176, 117 Stat. 2490). Section 811 of that Act states that “a person may manufacture a new aircraft, aircraft engine, propeller, or appliance based on a type certificate (TC) only if such other person is the holder of the type certificate or has permission from the holder.” Accordingly, our proposal was to add a new section to our regulations, 14 CFR 21.6, which would prohibit manufacture of a new aircraft, aircraft engine, or propeller based on a TC unless the manufacturer is the holder of the TC or has a licensing agreement from the holder to manufacture the product. The comment period on the proposal closed on April 18, 2005.

The Safe, Accountable, Flexible, and Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), Public Law 109-59, which was signed into law on August 10, 2005, contains an exception from the requirement that the manufacturer of a new aircraft based on a TC be the holder of the TC or have the permission of the TC holder. This exception is available with regard to the manufacture of only one aircraft, which the person seeking the exception must have begun manufacturing before August 5, 2004.

In light of this development, we are requesting public comment on the corresponding language we are proposing as a supplement to the original proposal (discussed below). We are not requesting comment on other portions of the original proposal at this time. The comments we received in response to the original proposal are posted in the electronic docket for public information purposes. We plan to respond to the issues raised by the commenters on the original proposal in the final rule document. We will also respond to any comments we receive in response to this supplementary proposal at that time.

The FAA proposes adding new § 21.6(a) that would prohibit a person from manufacturing a new aircraft, aircraft engine, or propeller based on a type certificate unless the person:

• Is the holder of the type certificate, or has a licensing agreement from the holder of the type certificate to manufacture the product; and

• Meets the requirements of subpart F or G of part 21.

The reference to subparts F and G means that the person would have to comply with our regulations governing production under a type certificate only or a production certificate, respectively, when manufacturing a new aircraft, aircraft engine, or propeller based on a type certificate. Proposed paragraph (a) is identical in content to § 21.6 in the original proposal.

Proposed § 21.6(b) would allow a person to manufacture one aircraft without meeting the requirements of paragraph (a), provided that person can provide evidence acceptable to the Administrator that he or she began manufacturing the aircraft before August 5, 2004.

The exception for a person who began to manufacture an aircraft before August 5, 2004 would apply only to aircraft, not to aircraft engines or propellers. This is based on the specific language of SAFETEA-LU, which specifically refers to aircraft, but not aircraft engines or propellers. The person seeking to manufacture a new aircraft under this exception would have to demonstrate to FAA's satisfaction that manufacturing began before August 5, 2004. Documentation that could be used to demonstrate manufacture of the aircraft prior to that date would include items such as: Receipts for purchase of parts or materials; dated photographs; and dated information received from the FAA related to the manufacturing or certification process for the specific aircraft.

Information collection requirements in proposed § 21.6 have previously been approved by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), and have been assigned OMB Control Number 2120-0005.

The FAA has determined that a review of the Convention on International Civil Aviation (ICAO) Standards and Recommended Practices is not warranted because there are no Standards and Recommended Practices that correspond to these proposed regulations.

Executive Order 12866, Regulatory Planning and Review, directs the FAA to assess both the costs and benefits of a regulatory change. We are not allowed to propose or adopt a regulation unless we make a reasoned determination that the benefits of the intended regulation justify the costs. Our assessment of this proposal indicates that its economic impact is minimal. Since its costs and benefits do not make it a “significant regulatory action” as defined in the Order, we have not prepared a “regulatory evaluation,” which is the written cost/benefit analysis ordinarily required for rulemaking proposals under the DOT Regulatory Policies and Procedures. We do not need to do the latter analysis where the economic impact of a proposal is minimal.

The Regulatory Flexibility Act (RFA) of 1980, (5 U.S.C. 601 et seq. ) directs the FAA to fit regulatory requirements to the scale of the business, organizations, and governmental jurisdictions subject to the regulation. We are required to perform a review when a proposed or final action will have a significant impact on a substantial number of “small entities” as defined by the Act. If we find that the action will have a significant impact, we must do a “regulatory flexibility analysis.”

This proposed rule implements a one-aircraft exception to the requirement to obtain the TC holder's permission for a person building a new aircraft based on a TC when that person's manufacture of the aircraft began before August 5, 2004. Its economic impact is minimal. Therefore, we certify that this proposed action would not have a significant economic impact on a substantial number of small entities.

The Trade Agreement Act of 1979 prohibits Federal agencies from engaging in any standards or related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this proposed rule and has determined that it will impose the same costs on domestic and international entities and thus has a neutral trade impact.

The Unfunded Mandates Reform Act of 1995 (the Act), enacted as Public Law 104-4 on March 22, 1995, is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. Such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $120.7 million in lieu of $100 million.

The proposed rule does not contain such a mandate. Therefore, the requirements of Title II of the Unfunded Mandates Reform Act of 1995 do not apply.

Section 1205 of the FAA Reauthorization Act of 1996 (110 Stat. 3213) requires the Administrator, when modifying regulations in Title 14 of the CFR in a manner affecting intrastate aviation in Alaska, to consider the extent to which Alaska is not served by transportation modes other than aviation, and to establish such regulatory distinctions as he or she considers appropriate. Because this proposed rule would apply to the certification of aircraft built by individuals or small businesses and their subsequent operation, it could, if adopted, affect intrastate aviation in Alaska. The FAA therefore specifically requests comments on whether there is justification for applying the proposed rule differently in intrastate operations in Alaska.

The FAA has analyzed this proposed rule under the principles and criteria of Executive Order 13132, Federalism. We determined that this action 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. Therefore, we determined that this proposed rule does not have federalism implications.

FAA Order 1050.1E identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this proposed rulemaking action qualifies for the categorical exclusion identified in paragraph 308(c)(1) and involves no extraordinary circumstances.

The FAA has analyzed this SNPRM under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 18, 2001). We have determined that it is not a “significant energy action” under the executive order because it is not a “significant regulatory action” under Executive Order 12866, and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

For the reasons stated above, the FAA proposes to amend part 21 of Title 14, Code of Federal Regulations as follows:

We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2005-22917; Directorate Identifier 2005-NM-157-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov .

You may examine the AD docket on the Internet at http://dms.dot.gov , or in person at the Docket Management Facility office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, notified us that an unsafe condition may exist on certain Bombardier Model CL-600-1A11 (CL-600), CL-600-2A12 (CL-601), and CL-600-2B16 (CL-601-3A, CL-601-3R, & CL-604) airplanes. TCCA advises that production inspections showed that the spring assembly that controls rudder balance may not have the correct pre-load on some airplanes. The spring assembly must be pre-loaded correctly so it can position the rudder close to its neutral position in case one of several linked components in the aft section of the rudder assembly disconnects during flight. If the rudder is not positioned close to neutral in this instance, excessive rudder deflections (side-to-side movements) may occur. In order to ensure that the rudder moves to neutral position and rudder deflections remain within acceptable limits, the balance spring assembly must be modified and rigged to suit the rudder of each airplane. No linked components in the aft section of the rudder assembly have disconnected in service; however, this condition, if not corrected, could result in uncommanded yaw movement and reduced controllability of the airplane.

Bombardier has issued the service bulletins in the following table.

We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2005-22918; Directorate Identifier 2005-NM-172-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

You may examine the AD docket on the Internet at http://dms.dot.gov, or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

The Direction Ge ne rale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified us that an unsafe condition may exist on certain Airbus Model A319-100 and A320-200 series airplanes. The DGAC advises that, in several incidents, plastic identification labels have been found floating in the fuel tanks. There are two types of labels and the information on the labels identifies each rib number in the vent box and the manhole door fasteners in the wing fuel tank, for inspection purposes. Inspection of the airplanes revealed that the varnish coating and adhesive on the labels had deteriorated and the labels detached from the wing structure. Detached labels floating in the fuel tank could be ingested into the fuel pumps and consequently enter into the engine fuel feed system. These conditions, if not corrected, could result in an engine shutdown.

Airbus has issued Service Bulletin A320-28-1102, Revision 01, dated February 11, 2005. The service bulletin describes procedures for repetitive detailed visual inspections of the four wing-tank fuel pumps and canisters for detached identification labels, and corrective action if necessary. The corrective action involves removing any label debris that is found, performing a detailed visual inspection for debris of the fuel filters and replacing the filters if necessary, and replacing the fuel pump if the inlet and outlet ports are blocked. The service bulletin also recommends sending an inspection report to Airbus.

Airbus has also issued Service Bulletin A320-57-1117, dated July 16, 2002. The service bulletin describes procedures for repetitive detailed visual inspections for detached identification labels in the collector cells between ribs 1 and 2, the surge tank between ribs 22 and 26, and the wing fuel tank and vent box, and corrective action if necessary. The corrective action involves removing any label debris that is found, removing any partially detached labels, and re-identifying certain fasteners and ribs.

The DGAC mandated the service information and issued French airworthiness directive F-2005-121, dated July 20, 2005, to ensure the continued airworthiness of these airplanes in France.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. We have examined the DGAC's findings, evaluated all pertinent information, and determined that we need to issue an AD for airplanes of this type design that are certificated for operation in the United States.

Therefore, we are proposing this AD, which would require accomplishing the actions specified in the service information described previously. For any wing-tank fuel pump failure that occurs, this proposed AD would also require performing a detailed inspection of the failed pump, the pump located in the same half wing, and the associated canister, and accomplishing any applicable corrective action, including replacing the pump.

The French airworthiness directive mandates changes to the master minimum equipment list (MMEL). This proposed AD will not mandate those MMEL changes because the limits imposed by the FAA-approved MMEL meet or exceed those mandated by the French airworthiness directive. We have coordinated this issue with the DGAC.

In this proposed AD, the “detailed visual inspections” specified in the service bulletins are referred to as “detailed inspections.” We have included the definition for a detailed inspection in a note in the proposed AD.

This proposed AD would affect about 74 airplanes of U.S. registry.

The inspection specified in Service Bulletin A320-28-1102 would take about 3 work hours (including an operational test) per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of this proposed inspection for U.S. operators is $14,430, or $195 per airplane, per inspection cycle.

The inspection specified in Service Bulletin A320-57-1117 would take about 6 work hours (including an operational test) per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of this proposed inspection for U.S. operators is $28,860, or $390 per airplane, per inspection cycle.

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 have 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 that the 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); and

3. 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.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

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 us any written relevant data, views, or arguments regarding this proposal. Send your comments to an address listed under ADDRESSES. Include “Docket No. FAA-2005-22594; Directorate Identifier 2005-NE-28-AD” in the subject line of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of the DOT Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78) or you may visit http://dms.dot.gov .

You may examine the docket that contains the proposal, any comments received and, any final disposition in person at the DOT Docket Offices between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone (800) 647-5227) is located on the plaza level of the Department of Transportation Nassif Building at the street address stated in ADDRESSES. Comments will be available in the AD docket shortly after the Docket Management Facility receives them.

The FAA has received eleven reports of failures of RRC manufactured tie bolts due to high cycle fatigue. The FAA believes that all of these failures are due to the inherent design of the part, which is also common to all of the PMA parts. Therefore, this AD requires removal of all RR and PMA tie-bolts. RRC has redesigned the tie bolt to minimize the risk of failure by high cycle fatigue. RRC manufactured these tie bolts under type and production certificate authority. EXTEX Ltd., Pacific Sky Supply Inc., and Superior Air Parts Inc. each independently manufactured replacement gas producer rotor assembly tie bolts under Parts Manufacturer Approval (PMA) authority. There have been no reported failures of PMA parts. The engines are installed in single-engine helicopters, along with several turboprop airplanes. This condition, if not corrected, could cause loss of engine power, resulting in a first stage turbine wheel overspeed and an uncontained engine failure.

We have evaluated all pertinent information from the four manufacturers' safety assessments and have identified an unsafe condition that is likely to exist or develop in other RRC 250-B17, -B17B, -B17C, -B17D, -B17E, -B17F, -B17F/1, -B17F/2, 250-C18, -C20, -C20B, -C20F, -C20J, -C20R, -C20R/1, -C20R/2, -C20R/4, -C20S, and -C20W series turboprop and turboshaft engines that have any of the following gas producer rotor assembly tie bolts installed:

• EXTEX Ltd.: P/N A23008020, and E23008020

• Pacific Sky Supply Inc.: P/N 23008020P

• Rolls-Royce Corporation: P/Ns 23008020, 6843388 and 6876991

• Superior Air Parts Inc.: P/N A23008020

We are proposing this AD, which would remove these P/N gas producer rotor assembly tie bolts as specified in the compliance section of this proposed AD.

About 4,000 RRC 250-B and 250-C Series turboprop and turboshaft engines with affected P/Ns of gas producer rotor assembly tie bolts manufactured by EXTEX Ltd., Pacific Sky Supply Inc., Rolls-Royce Corporation (RRC), and Superior Air Parts Inc. are in the worldwide fleet. We estimate that 700 engines installed on aircraft of U.S. registry would be affected by this proposed AD. We also estimate that it would take about 20 work hours per engine to perform the proposed actions, and that the average labor rate is $65 per work hour. Required parts would cost about $421 per engine. Based on these figures, we estimate the total cost of the proposed AD to U.S. operators to be $1,204,700.

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 have 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 that the 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); and

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

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

Under the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend 14 CFR part 39 as follows:

We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed under ADDRESSES. Include “Docket No. FAA-2005-22919; Directorate Identifier 2005-NM-087-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments submitted by the closing date and may amend the proposed AD in light of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of our docket Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You can review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you can visit http://dms.dot.gov.

You can examine the AD docket on the Internet at http://dms.dot.gov, or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System (DMS) receives them.

The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified us that an unsafe condition may exist on certain Airbus Model A319-100, A320-200, A321-100, and A321-200 series airplanes. The DGAC advises that an operator reported cracks in the lavatory floor pans of the affected airplanes in its fleet. Further investigation showed that the cracks resulted from corrosion in the lower part of the lavatory wall, possibly caused by liquid that entered during cleaning and operation, and by rain entering through the main entry door. Extensive corrosion of the lower part of the lavatory wall could compromise the structural integrity of the cabin attendant seat (CAS) attachments. This condition, if not corrected, could result in injury to the cabin attendants during a crash landing.

Airbus has issued Service Bulletin A320-25-1365, dated February 18, 2005. The service bulletin describes procedures for doing a repetitive detailed visual inspection for corrosion and damage in the inside and outside lower walls of each type A, D, E, and F lavatory wall that has at least one wall-mounted CAS. The service bulletin also describes procedures for related investigative and corrective actions if necessary, including any supporting non-destructive testing. The related investigative and corrective actions are as follows:

If no corrosion is detected, the service bulletin describes procedures for repeating the inspection. If any corrosion or damage is detected during any inspection that does not exceed the allowable limits specified in the service bulletin, the service bulletin gives procedures for cleaning the area with cleaning agent, protecting against further corrosion, operating the CAS within specified limits, repeating the inspection, and, within a specified amount of time, repairing the corroded wall.

If any corrosion or damage is detected during any inspection that does exceed the allowable limits specified in the service bulletin, the service bulletin gives procedures for repairing the wall within a specified amount of time, and specifies not to use the affected CAS until the wall is repaired.

The repair depends on the extent of damage and includes doing one of the following, as applicable:

• Installing a temporary aluminum repair for the existing aluminum lavatory wall in accordance with procedures in the service bulletin;

• Repairing the lower attachments of the existing aluminum lavatory walls in accordance with the lavatory component maintenance manual (CMM);

• Repairing the existing aluminum lavatory wall with composite material in accordance with the lavatory CMM (the service bulletin specifies that no further action is necessary after this repair); or

• Replacing the existing aluminum lavatory wall with a composite wall in accordance with the lavatory CMM, or in accordance with additional Airbus service bulletins described below, as applicable. (The service bulletin specifies that no further action is necessary after this repair).

Doing the temporary aluminum repair in accordance with the service bulletin ends the repetitive inspections in the service bulletin. However, the service bulletin specifies that operators who do the temporary aluminum repair should, within 18 months, repair the wall with composite material, or permanently replace the aluminum wall with a new wall made of composite material. For lavatories that have the repair to the lower attachments of the aluminum lavatory wall in accordance with the lavatory CMM, the service bulletin specifies that operators repeat the detailed visual inspection until the aluminum wall has the temporary aluminum repair, or until it is repaired with composite material, or until it is permanently replaced with a new wall made of composite material.

The service bulletin notes that the temporary aluminum repair and the repair to the lower attachments of the aluminum lavatory walls can each be done only one time. If any inspection shows corrosion damage after the lower attachments are repaired, the service bulletin states that the wall must have the temporary aluminum repair, or the composite repair, or be replaced with a new wall made of composite material; as applicable to the extent of damage.

Airbus has also issued Service Bulletin A320-25-1289, Revision 01, dated October 29, 2003 (for lavatory A); and Service Bulletin A320-25-1357, dated July 19, 2004 (for lavatory F). These service bulletins describe procedures for replacing the existing aluminum lavatory wall for lavatory types A and F respectively, with a wall made of composite material.

The compliance times for doing the inspections and related investigative and corrective actions described above are summarized in Figure 1 Sheet 1 of Airbus Service Bulletin A320-25-1365, dated February 18, 2005. The intervals for repeating the detailed inspection are from 15 months to 18 months depending on previous repairs. The compliance time specified for doing applicable repairs ranges from 600 flight hours to 18 months, depending on the extent of the damage.

We have determined that accomplishment of the actions specified in the service information will adequately address the unsafe condition. The DGAC mandated the service information and issued French airworthiness directive F-2005-046, dated March 16, 2005, to ensure the continued airworthiness of these airplanes in France.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. We have examined the DGAC's findings, evaluated all pertinent information, and determined that we need to issue an AD for products of this type design that are certificated for operation in the United States.

Therefore, we are proposing this AD, which would require accomplishing the actions specified in the service information described previously.

In this proposed AD, the “detailed visual inspection” specified in the Airbus service bulletin is referred to as a “detailed inspection.” We have included the definition for a detailed inspection in a note in the proposed AD.

This proposed AD would affect about 393 airplanes of U.S. registry. The proposed inspection would take about 2 work hours per lavatory, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the proposed AD for U.S. operators is $51,090, or $130 per lavatory, per inspection cycle.

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 have 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 that the 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); and

3. 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.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

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

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2005-22745/Airspace Docket No. 05-ACE-31.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://dms.dot.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov or the Superintendent of Document's Web page at http://www.access.gpo.gov/nara.

Additionally, any person may obtain a copy of this notice by submitting a request to the Federal Aviation Administration (FAA), Office of Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW., Washington, DC 20591, or by calling (202) 267-8783. Communications must identify both docket numbers for this notice. Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

This notice proposes to amend Part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing a Class E airspace area extending upward from 700 feet above the surface at Hill City Municipal Airport, KS. The establishment of Area Navigation (RNAV) Global Positioning System (GPS) Instrument Approach Procedures (IAP) to Runways (RWY) 17 and 35 has made this action necessary. The intended effect of this proposal is to provide adequate controlled airspace for Instrument Flight Rules operations at Hill City Municipal Airport, KS. The area would be depicted on appropriate aeronautical charts.

Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9N, dated September 1, 2005, and effective September 16, 2005, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document would be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposed rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This proposed regulation is within the scope of that authority since it would contain aircraft executing instrument approach procedures to Hill City Municipal Airport.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Part 389 of Title 14 of the Code of Federal Regulations—Fees and Charges for Special Services—describes certain special services related to aviation economic proceedings, such as certification of new air carriers, licensing of air taxi operators, and award of international route authority to U.S. airlines, that the Department provides to the public, and sets forth the fees and charges applicable to those services.

In January 1999, we issued a Notice of Proposed Rulemaking (NPRM), 64 FR 3229, to obtain comments on proposed revisions to the filing fee schedule and related provisions of Part 389. In the main, the NPRM proposed (1) To eliminate, except in the case of a treaty or agreement, the waiver of processing fees for those foreign air carriers whose home countries waive processing fees for U.S. air carriers, as set forth in existing section 389.24; (2) to revise and update the individual services and related fee amounts included on the schedule contained in existing section 389.25(a), including significant fee increases for several existing services and new fees for several services not previously covered; and (3) to implement certain procedural changes to facilitate processing of licensing applications.

Our proposed fee amounts were based on work-process analysis of more than 600 service applications, including (1) the direct labor costs incurred to process individual applications and (2) the office space, utilities and related overhead costs allocable to individual applications based on the organizational structure of the Office of the Assistant Secretary for Avaition and International Affairs.

We received comments on the NPRM from the British Government, the Air Transport Association of America, the International Air Carrier Association, and representatives of 20 foreign air carriers. All commenters objected to our proposal to eliminate the waiver of foreign air carrier processing fees as contrary to U.S. law and provisions of bilateral agreements, or as counterproductive for U.S. air carriers. Similarly, all contested the rationale for, or proposed amount of, one or more of our individual fee items as unreasonable, unwarranted or excessive. No party objected to our proposed changes to facilitate applications processing.

Following our receipt and review of comments on the NPRM, unanticipated events interrupted the rulemaking process. In particular, the horrific events of September 11, 2001, and their aftermath required us to redirect resources to more immediate priorities. Under the Air Transportation Safety and Stabilization Act (Pub. L. 107-42), for example, we were charged with dispensing up to $5 billion in direct payments to assist air carriers that had suffered losses as a result of the September 11 attacks. The delays experienced since September 11 have greatly reduced the utility of the labor cost data underlying our 1999 fee proposal. That proposal has been further compromised by outdated overhead allocations due to numerous organizational changes which have occurred within the Office of the Assistant Secretary for Aviation and International Affairs since the NPRM was issued. For these reasons, the Department believes that the labor and overhead cost estimates used to develop its proposed fees are no longer timely and do not support finalization of the proposed rule. We are, therefore, withdrawing the 1999 NPRM.

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rule we are proposing to approve with the date that it was adopted by the local air agency and submitted by the Arizona Department of Environmental Quality (ADEQ).

On September 28, 2005, the rule submittal was found to meet the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review.

On April 28, 2004 (69 FR 23103), EPA finalized a limited approval and limited disapproval of a version of Rule 2-8-300.

Section 110(a) of the CAA requires states to submit regulations that control volatile organic compounds, oxides of nitrogen, particulate matter, and other air pollutants which harm human health and the environment. This rule was developed as part of the local agency's program to control particulate matter.

The purposes of the rule revisions relative to the SIP rule are as follows:

• The clarification is added that provisions of the rule apply to an “existing source,” a “point source,” and a “stationary source,” which are appropriately defined.

• The opacity standard is decreased from 40% in all areas to (a) 20% in nonattainment or maintenance attainment areas after June 2, 2005 and (b) 20% in attainment or unclassified areas after April 23, 2006.

• A provision is added to allow submittal of a petition to the Control Officer (CO) by September 15, 2005 for an alternative opacity standard (AOS), if the source complies with the applicable particulate matter (PM) mass rate standard, but cannot comply with the 20% opacity standard. Requirements for the petition contents are listed. If an AOS is approved by the CO, he shall submit the AOS to the EPA Administrator for approval as a SIP revision. If an AOS is not approved, the source shall comply with the 20% opacity standard or submit a compliance plan before April 23, 2006.

• A definition of “process weight rate” is added to clarify its applicability to continuous processes and batch processes.

The TSD has more information about this rule.

Generally, SIP rules must be enforceable (see section 110(a) of the CAA), must require reasonably available control measures (RACM), including reasonably available control technology (RACT) in moderate PM-10 nonattaiment areas (see section 189(a)), must require best available control measures (BACM), including best available control technology (BACT) in serious PM-10 nonattaiment areas (see section 189(b)), and must not relax existing requirements (see sections 110(l) and 193). A portion of PCAQCD is designated attainment, a portion is designated moderate nonattainment, and a portion is designated serious nonattainment for PM-10.

The following guidance documents were used for reference:

• Requirements for Preparation, Adoption, and Submittal of Implementation Plans , U.S. EPA, 40 CFR part 51.

• PM-10 Guideline Document (EPA-452/R-93-008).

The deficiency cited in the previous limited approval/limited disapproval action of PCAQCD Rule 2-8-300 is as follows: The 40% opacity standard does not meet the requirements of BACM/BACT. Analogous generic 20% opacity standards meet the requirements of RACM/RACT in other parts of the country, and we believe BACM/BACT in PCAQCD should be at least as stringent. See 69 FR 23103 (April 28, 2004).

The revision to a 20% opacity standard in the submitted rule corrects the cited deficiency for unclassified, attainment, maintenance, and moderate nonattainment areas to a level comparable to RACM/RACT in other parts of the country. We believe that BACM/BACT, as required for the serious nonattainment area in PCAQCD, should be at least as stringent as RACM/RACT. We do not have justification for an opacity standard more stringent than 20% to fulfill BACM/BACT for general PM-10 sources in the serious nonattainment area. Therefore, we believe that the 20% opacity standard fulfills RACM/RACT and BACM/BACT for the general PM-10 sources to which the rule is applicable, even though some specific PM-10 sources might achieve a more stringent opacity standard in fulfilling BACM/BACT.

We believe this rule is consistent with the relevant policy and guidance regarding enforceability, SIP relaxations, and fulfilling the requirements of RACM/RACT and BACM/BACT and should be given full approval.

Because EPA believes the submitted rule fulfills all relevant requirements, we are proposing to fully approve it as described in section 110(k)(3) of the CAA. We will accept comments from the public on this proposal for the next 30 days. Unless we receive convincing new information during the comment period, we intend to publish a final approval action that will incorporate the rule into the federally enforceable SIP.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This proposed action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule proposes to approve pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This proposed rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely proposes to approve a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

This proposal addresses the correction of the boundary of the Phoenix metropolitan 1-hour ozone nonattainment area under section 110(k)(6) of the Clean Air Act to exclude the Gila River Indian Reservation. In the Rules and Regulations section of this Federal Register , we are taking direct final action to correct the boundary without prior proposal because we believe this correction action is not controversial. If we receive adverse comments, however, we will publish a timely withdrawal of the direct final rule and address the comments in subsequent action based on this proposed rule. We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive comments, no further activity is planned. For all the reasons explained in the parallel direct final notice, we propose to correct the boundary of the Phoenix metropolitan 1-hour ozone nonattainment area to exclude the Gila River Indian Reservation. For further information on this proposal and the rationale underlying our proposed action, please see the direct final action.