ML15182A117

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Comment (2) of R. Vann Bynum on Behalf of Shine Medical Technologies on on NUREG-2183, Environmental Impact Statement for the Construction Permit for the Shine Medical Radioisotope Production Facility, Draft Report for Comments (NRC-2013-00
ML15182A117
Person / Time
Site: SHINE Medical Technologies
Issue date: 06/16/2015
From: Bynum R V
SHINE Medical Technologies
To: Bladey C K
Division of Administrative Services
SECY RAS
References
80FR27710 00002, NRC-2013-0053, NUREG-2183, SMT-2015-032
Download: ML15182A117 (10)


Text

L June 16, 2015 SMT-2015-032 Cindy Bladey Office of Administration Mail Stop: OWFN-12-H08 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 K~2Y 42/s~ 277/12

References:

(1) U.S. Nuclear Regulatory Commission, "Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility" (Draft Report for Comment), NUREG-2183, May 2015 (ML15127A241)

SHINE Medical Technologies, Inc. Comments on NUREG-2183, "Environmental Impact Statement for the Construction Permit for the SHINE Medical Radioisotope Production Facility, Draft Report for Comments" (NRC-2013-0053)

SHINE Medical Technologies, Inc. (SHINE) appreciates the opportunity to comment on NUREG-2183, the draft environmental impact statement (EIS) for the Construction Permit for the SHINE Medical Radioisotope Production Facility (Reference 1).Enclosure 1 provides the SHINE comments on NUREG-2183.

SHINE has determined that these comments are administrative, because they do not affect the conclusions provided in NUREG-2183.

If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.

Very truly yours, R. Vann Bynum, Ph.D.Chief Operating Officer SHINE Medical Technologies, Inc.Docket No. 50-608 Enclosure cc: Project Manager, USNRC Environmental Project Manager, USNRC....7 CD-:X))SUNSI Review Complete Template = ADM -013 E-RIDS= ADM -03 Add= --2.2/). "- -." --,-2555 Industrial Drive I Monona, WI 53713 1 P (608) 210-1060 1 F (608) 210-2504 1 www.shinemed.com l, ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. COMMENTS ON NUREG-2183,"ENVIRONMENTAL IMPACT STATEMENT FOR THE CONSTRUCTION PERMIT FOR THE SHINE MEDICAL RADIOISOTOPE PRODUCTION FACILITY, DRAFT REPORT FOR COMMENTS" (NRC-2013-0053)

Section 1.0 -Introduction Page 1-3, Line 36 Page 1-3, Line 44 Page 1-8, Line 4 A single value of 5,000 6-day curies (Ci) is converted to two values of 6-day becquerels (Bq) (2x1 014 and 3x101 4). Recommend removing the 3x1 014 6-day Bq value.The American Medical Isotopes Production Act of 2012 appears to have been incorporated into Section 2065 of Title 42 of the U.S. Code, not Section 3171. Subpart F of the National Defense Authorization Act for Fiscal Year 2013, which includes Section 3171, describes the American Medical Isotopes Production Act of 2012. Recommend revising the U.S. Code reference to 42 U.S.C. 2065, consistent with Section 2.7.1.2, Section 4.9.1, and Section 4.13.9.The American Medical Isotopes Production Act of 2012 appears to have been incorporated into Section 2065 of Title 42 of the U.S. Code, not Section 3171. Subpart F of the National Defense Authorization Act for Fiscal Year 2013, which includes Section 3171, describes the American Medical Isotopes Production Act of 2012. Recommend revising the U.S. Code reference to 42 U.S.C. 2065, consistent with Section 2.7.1.2, Section 4.9.1, and Section 4.13.9.Section 2.0 -Proposed Federal Action Page 2-5, Line 8 Page 2-5, Line 14 Page 2-7, Line 1 As described in the SHINE Response to RAI 19.2-1 (Reference 1), a concrete batch plant will not be located on the proposed SHINE site during construction.

Recommend removing "concrete batch plant operation" from the list of activities included in construction.

As described in the SHINE Response to RAI 19.2-1 (Reference 1), a concrete batch plant will not be located on the proposed SHINE site during construction.

Recommend removing the discussion of feed materials necessary for operating the concrete batch plant.The SHINE Waste Staging and Shipping Building is incorrectly labeled as the Waste Storage and Shipping Building.

Recommend revising accordingly.

Page 1 of 9

&Page 2-7, Line 17 Page 2-8, Line 5 Page 2-11, Line 10 Page 2-11, Line 28 Page 2-11, Line 32 Page 2-11, Line 41 Page 2-12, Line 38 Page 2-12, Line 42 Page 2-13, Line 38 Page 2-14, Line 3 The SHINE Response to RAI 19.2-7 (Reference

2) clarified the expected number of truck deliveries per month (36), the number of medical isotope shipments per month (39), the average number of radioactive waste shipments per year (25.6), and the number of off-site (non-radiological) waste shipments per month (1). Recommend revising the number of shipments and deliveries accordingly.

Typographical error. Recommend replacing "An individual irradiation unit would comprise..." with "An individual irradiation unit would be comprised of...It is stated that the deuterium ion beam strikes tritium nuclei, resulting in lighter hydrogen atoms and neutrons being produced.

However, the deuterium ion beam striking the tritium gas results in the production of helium nuclei and neutrons rather than lighter hydrogen atoms, as described in Subsection 19.2.2.1 of the PSAR. Recommend revising accordingly.

The off-gas system being described recombines radiolytically-produced hydrogen and oxygen and captures iodine using an adsorption material.The off-gas system handles and contains radiolytic and fission products gases, rather than specifically recovering xenon-1 33 and iodine-1 31.Recommend revising accordingly.

The hot cells in the SHINE facility are not containments.

Recommend revising the parenthetical to state, "shielded nuclear radiation confinement chambers".

The purification process described would yield a high-purity product. The dissolution and evaporation processes, which occur as part of the SHINE extraction process, yield a crude Mo-99 product, rather than a high purity product. Recommend revising accordingly.

The SHINE facility does not include a diesel-driven fire pump system.The fire water supply system, described in Subsection 9a2.3.3 of the PSAR, includes an electric motor-driven fire pump and a diesel engine-driven fire pump. In addition, as described in the SHINE Response to Proposed Action Request #3 (Reference 3), the 1,860 annual gallons of diesel fuel estimate includes testing and maintenance on both the standby diesel generator and the diesel-driven fire pump. Recommend revising accordingly.

The SHINE facility includes a single natural gas-fired boiler, as described in the SHINE Response to Air Quality Request #9 (Reference 3).Recommend revising accordingly.

Typographical error. Recommend replacing "Ordiance" with "Ordinance".

Typographical error. Recommend replacing "Ordiance" with "Ordinance".

Page 2 of 9 Page 2-14, Line 10 Page 2-15, Line 4 Page 2-15, Line 22 Page 2-16, Line 29 As described in Subsection 5a2.1.1 of the PSAR, the Primary Closed Loop Cooling System (PCLS) removes heat from the target solution vessel (TSV) via the exterior surfaces of the TSV. Recommend revising the wording to state, 'The primary closed-loop cooling system would remove heat from the target solution vessel by actively circulating water along the exterior surfaces of the vessel." The neutron drivers are expected to be replaced on an approximately yearly basis, as described in Subsection 19.2.5.3.1.

Recommend revising the parenthetical to state, "i.e., the neutron driver that would be periodically replaced".

The TSV is part of the subcritical assembly system, which is separate from the TSV off-gas system. Recommend revising the wording to reflect Subsection 19.4.2.1.2.1.1 of the PSAR, which states, "Process off-gases are treated in two separate, but connected, systems: the target solution vessel (TSV) off-gas system and the process vessel vent system (PVVS)." Class A waste is shipped approximate yearly to the EnergySolutions disposal site, as described in Subsection 19.2.5.3.1 of the PSAR;however, one year is not a limit of accumulation/storage.

Recommend revising the wording to state, "Class A waste is shipped approximately yearly to the EnergySolutions disposal site." Section 3.0 -Affected Environment Page 3-1, Line 35 Page 3-29, Line 34 Page 3-33, Line 1 0.2 percent of the proposed SHINE site is developed open space, not developed land or open space. Recommend revising accordingly.

As described in Section 3.3.1 of the Preliminary Hydrological Analyses of the SHINE site, provided as Attachment 23 to Enclosure 1 of Reference (3), advective travel time analyses would be updated for the Preliminary Safety Analysis Report (PSAR) when a full year of groundwater monitoring data is available.

Table 2.4-13 of the PSAR provides the SHINE estimate for advective travel time to the Rock River.Recommend revising the wording to state, "SHINE estimated that the expected travel time to the Rock River is 9.0 years." Table 3-8, Common and Abundant Wildlife Observed on or Near the Proposed Site, contains wildlife which SHINE did not classify as either Common or Abundant.

SHINE field surveys classified the abundance of Canadian geese as "occasional," the abundance of red-tailed hawk as"uncommon," the abundance of killdeer as "occasional," and the abundance of field sparrow as "uncommon." In addition, although the field survey abundance of avifaunal species was provided by SHINE in Table 19.3.5-5 of the PSAR, SHINE did not classify the abundance of mammals or reptiles and amphibians in field surveys. Recommend revising the title of Table 3-8 to '"Wildlife Observed On or Near the Proposed Site." Page 3 of 9 Page 3-33, Line 1 Page 3-37, Line 41 Page 3-49, line 44 Page 3-50, Line 28 The scientific name of the northern cardinal is "Cardinalis cardinalis" and the scientific name of the striped skunk is "Mephitis mephitis." Recommend revising Table 3-8 accordingly.

Recommend revising the wording "Given the available information, the NRC staff concludes that no Federally listed, proposed, or candidate species is unlikely to occur within the action area." to "Given the available information, the NRC staff concludes that no Federally listed, proposed, or candidate species is likely to occur within the action area." The Fireside Theater is the Fireside Dinner Theatre, and it is located on Janesville Avenue in Fort Atkinson, Wisconsin.

It is not located in Janesville, Wisconsin.

Recommend removing the Fireside Theater from the list of tourist attractions and activity centers in Janesville.

The nearest snowmobile trail to the SHINE site was described in Subsection 19.3.7.2.5.3 of the PSAR. Recommend revising the citation (SHINE 2013b) to (SHINE 2013a).Section 4.0 -Environmental Impacts of Construction, Operations, and Decommissioning Page 4-1, Line 26 Page 4-1, Line 33 Page 4-1, Line 35 Page 4-2, Line 30 Page 4-6, Line 9 Page 4-7, Line 14 Page 4-7, Line 14 Page 4-8, Line 34 Typographical error. Recommend replacing "describe" with"described in".The proposed SHINE site currently includes 0.18 ac. of developed open space, not undeveloped open areas. Recommend revising accordingly.

The proposed SHINE site currently includes 0.18 ac. of developed open space, not undeveloped open areas. Recommend revising accordingly.

The total value of temporarily disturbed land in Table 4-1 does not account for the 0.62 ac. of off-site land. Recommend revising the total value of disturbed land to 15.16 ac. (6.13 ha.).Typographical error in the words "Semi Tractor" in the equipment listing provided in Table 4-2.As shown in Revision 6 of CALC-2013-0007, provided as Attachment 3 to Enclosure 1 of Reference (2), hydrocarbons emissions from diesel equipment exhaust are estimated to be 22 tons/year, not 2 tons/year.

Recommend revising the value to 22 tons/year, and the corresponding"Total" and "Percent of Rock County Annual Emissions" for hydrocarbons accordingly.

Reference MRI 2006 describes a recommended PM 2.5/PM 1 0 ratio of 0.1, not PM 1 0/PM 2.5.Recommend revising Note (b) of Table 4-3 to state,"...and for PM 2.5PM 1 0, a ratio of 0.1 (EPA 1984; MRI 2006)." Section 4.14 does not contain a reference for (SHINE 2013).Recommend revising the citation to (SHINE 2013b), which provided measures to minimize emissions due to worker vehicles.Page 4 of 9 Page 4-9, Line 31 Page 4-11, Line 3 Page 4-12, Line 17 Page 4-13, Line 31 Page 4-13, Line 31 Page 4-14, Line 8 Page 4-15, Line 1 Page 4-15, Line 1 Page 4-21, Line 43 Page 4-23, Line 12 Typographical error. Recommend replacing "construction" withoperations." Typographical error. Recommend replacing "Version 123145" with"Version 12345." SHINE does not expect to ship all off-site (radiological) waste shipments to Clive, Utah. In order to determine bounding emissions values during the operations phase, SHINE assumed all off-site (radiological) waste shipments are shipped to the EnergySolutions facility in Clive, Utah, as it is furthest disposal facility from the SHINE facility.

The expected waste disposal facilities for SHINE's off-site (radiological) waste shipments are provided in Subsection 19.4.10.1.1 of the PSAR. Recommend revising the wording to state, "However, these emissions would be emitted beyond the ROI because they are expected to be shipped to facilities in Clive, Utah;Andrews, Texas; and/or Kingston, Tennessee (SHINE 2013a) and would therefore traverse various counties, AQCRs, and states." Typographical error in the Total Activity for the Backhoe/Loader Cat 430.Recommend revising the Total Activity to 3,542 hours0.00627 days <br />0.151 hours <br />8.96164e-4 weeks <br />2.06231e-4 months <br />.Typographical error in the Total Activity for the Pickup Truck F-250.Recommend revising the Total Activity to 9,583 hours0.00675 days <br />0.162 hours <br />9.63955e-4 weeks <br />2.218315e-4 months <br />.SHINE does not expect to ship all off-site (radiological) waste shipments to Clive, Utah. See previous comment for Page 4-12, Line 17.Since the decommissioning phase is only expected to be six months, SHINE provided air emissions estimates during decommissioning in tons, not as an annual rate (i.e., tons/year).

Recommend revising the units in Table 4-9 to tons.SHINE revised the total emissions during the decommissioning phase in Revision 6 of CALC-2013-0007, provided as Attachment 3 to Enclosure 1 of Reference (2). Recommend revising Table 4-9 to reflect the most current SHINE estimation of emissions during the decommissioning phase.An estimate of the amount of water to be used for dust mitigation and suppression during construction was provided via Reference (3).Recommend revising the reference citation from (SHINE 2013a) to (SHINE 2013b).Figure 19.2.3-1 of the PSAR provides an average daily demand quantities for the SHINE facility, and those average values are not based on 5.5 days of water usage per week. Though a single irradiation cycle is 5.5 days, the SHINE facility will be in operation seven days per week.Recommend revising Note (a) of Table 4-11 to state, "Values are average daily demand. Conversions are rounded." Page 5 of 9 Page 4-24, Line 29 Page 4-28, Line 19 Page 4-31, Line 29 Page 4-36, Line 6 Page 4-37, Line 31 Page 4-37, Line 38 Page 4-37, Line 45 Page 4-39, Line 34 Page 4-40, Line 38 Page 4-42, Line 40 Page 4-46, Line 2 Page 4-46, Line 3 The proposed SHINE facility would permanently convert 0.18 ac. of developed open space into an industrial area, not developed or open areas. Recommend revising accordingly.

Per the NRC's response to Comment 02-1 in Section A.1.6 of Appendix A, the last attempt to contact the Forest County Potawatomi was in February 2015. Recommend revising accordingly.

SHINE estimated there would be 26 Equipment Operator/Engineers available in Rock County during the Decommissioning Phase, as shown in Table 19.4.7-1 of the PSAR. Recommend revising the "Available Labor Force in ROI" for Equipment Operator/Eng.

during Decommissioning from 20 to 26, and revising the corresponding "Total" accordingly.

The SHINE Response to RAI 19.2-5 (Reference

1) clarified the peak number of workers at the site during the construction phase (451).Recommend revising the peak number of workers at the site during construction from 421 to 451.A description of the Chemical Hygiene Plan was provided via Reference (3). Recommend revising the reference citation from (SHINE 2013a) to (SHINE 2013b).A description of the Chemical Hygiene Plan was provided via Reference (3). Recommend revising the reference citation from (SHINE 2013a) to (SHINE 2013b).A description of the Chemical Hygiene Plan was provided via Reference (3). Recommend revising the reference citation from (SHINE 2013a) to (SHINE 2013b).The SHINE Response to RAI 19.2-2 (Reference
1) clarified the duration of the decommissioning phase for the SHINE facility (six months).Recommend revising the duration of decommissioning period and the resulting estimate of recordable cases of non-fatal workplace injuries and illnesses during the decommissioning period.Class A waste is shipped approximate yearly to the EnergySolutions disposal site, as described in Subsection 19.2.5.3.1 of the PSAR;however, one year is not a limit of accumulation/storage.

Recommend revising the wording to state, "Class A waste is shipped approximately yearly to the EnergySolutions disposal site." Table 3-21 provides average daily traffic counts in the vicinity of the proposed SHINE facility.

Recommend revising the table reference from Table 3-14 to Table 3-21.Recommend removing underline from the text.Recommend removing underline from the text.Page 6 of 9 Page 4-47, Line 12 Page 4-47, Line 28 Page 4-48, Line 1 Page 4-70, Line 17 The radiation effects of the postulated maximum hypothetical accident (MHA) in the radioisotope production facility would be mitigated by the walls in the noble gas removal system room and isolated by Radiologically Controlled Area (RCA) Ventilation Zone 1 (RVZ1) and RCA Ventilation Zone 2 (RVZ2), as described in Subsection 13b.2.1.3 of the PSAR. Recommend revising the wording to state, 'The radiation effects of this MHA in the radioisotope production facility would be mitigated by the walls in the noble gas removal system room and isolated by RVZ1 and RVZ2." Only the RVZ1 and RVZ2 portions of the RCA Ventilation System (RV)are safety-related.

RCA Ventilation Zone 3 (RVZ3) and Facility Ventilation Zone 4 (FVZ4) are nonsafety-related (see Table 3.5-1 of the PSAR). Recommend revising the wording to state, 'These safety-related structures, systems, and components include the systems described above (i.e., the irradiation unit cell confinement, radiation monitoring system, pipe penetration shields, TSV off-gas system, noble gas removal system walls, RVZ1, RVZ2, secure chemical containers, and other safety-related structures, systems, and components)." SHINE revised the description of the hazardous chemical dispersion analysis for the SHINE facility provided in Subsections 13b.3.2 and 19.4.11.2.13 of the PSAR via Reference (4). Recommend revising the description of the SHINE hazardous chemical dispersion analysis contained in Section 4.11.2, including the results reported in Table 4-13, to be consistent with the revised Subsection 19.4.11.2.13 and Table 19.4.11-1 provided via Reference (4).Section 4.14 does not contain a reference for (SHINE 2013).Recommend revising the citation to (SHINE 2013a).Section 5.0 -Alternatives Page 5-10, Line 9 Page 5-20, Line 39 Page 5-65, Line 21 Page 5-69, Line 26 Typographical error in the total acreage within a five mile radius of the SHINE site provided in Table 5-2. Recommend revising the total acreage within a five mile radius of the SHINE site from "50,2645 ac" to"50,265 ac".Typographical error. Recommend replacing "common cottontail" with"common cattail".Recommend removing underline from the text of both plants in Table 5-11.The SHINE Response to RAI 19.2-5 (Reference

1) clarified the peak number of workers that SHINE anticipates at the site during the construction phase (451). Recommend revising the number of workers needed to construct the proposed facility from 420 to 451.Page 7 of 9 Page 5-69, Line 31 Page 5-77, Line 32 Page 5-81, Line 33 Page 5-96, Line 9 Page 5-102, Line 2 The SHINE Response to RAI 19.2-5 (Reference
1) clarified the peak number of workers that SHINE anticipates at the site during the construction phase (451). Recommend revising the number of workers needed to construct the proposed facility from 420 to 451.The Stevens Point site is located in Census Tract 9607.02, not Census Tract 9607.2. Recommend revising accordingly.

The Stevens Point site is located in Census Tract 9607.02, not Census Tract 9607.2. Recommend revising accordingly.

Although molybdenum-100 is a naturally occurring isotope, molybdenum enriched in molybdenum-100 is not naturally occurring.

Recommend revising the wording, "For the linear-accelerator-based alternative, molybdenum-99 would be produced by irradiating natural molybdenum (molybdenum enriched in the radioisotope molybdenum-100) in an accelerator." to state, "For the linear-accelerator-based alternative, molybdenum-99 would be produced by utilizing an accelerator to irradiate natural molybdenum that has been enriched in the radioisotope molybdenum-1 00." The proposed SHINE site would include 0.18 ac. of developed open space, not undeveloped open areas. Recommend revising the description provided for the cost benefit category "Land Use" accordingly.

Section 6.0 -Conclusions Page 6-2, Line 1 Page 6-9 Page 6-10, Line 6 The proposed SHINE site would include 0.18 ac. of developed open space, not undeveloped open areas. Recommend revising the Summary of Impact for Land Use accordingly.

SHINE will not be providing a traffic signal at the entrance and exit to the SHINE site, as described in the SHINE Response to Transportation Request #1 (Reference 3). The increase in traffic volume from employees working at the SHINE facility results in a slight degradation in the level of service at the intersection of U.S. Highway 51 and State Highway 11 during the morning peak hour, resulting in an increased delay at the intersection, as described in Subsection 19.4.7.2.1 of the PSAR.Optimizing the signal timing at the intersection to accommodate a greater turning movement from westbound State Highway 11 to southbound U.S. Highway 51 would mitigate traffic delays. Recommend revising the Mitigation Measures for Transportation accordingly.

Construction, operations, and decommissioning would require 0.18 ac. of developed open space, not undeveloped open areas. Recommend revising accordingly.

Page 8 of 9 I, Appendix A -Comments Received on the SHINE Medical Radioisotope Production Facility Environmental Review Page A-17, Line 21 The American Medical Isotopes Production Act of 2012 appears to have been incorporated into Section 2065 of Title 42 of the U.S. Code, not Section 3171. Subpart F of the National Defense Authorization Act for Fiscal Year 2013, which includes Section 3171, describes the American Medical Isotopes Production Act of 2012. Recommend revising the U.S. Code reference to 42 U.S.C. 2065, consistent with Section 2.7.1.2, Section 4.9.1, and Section 4.13.9.References (1) SHINE Medical Technologies, Inc. letter to NRC, dated October 15, 2014, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML14296A189)

(2) SHINE Medical Technologies, Inc. letter to NRC, dated February 6, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML15043A404)

(3) SHINE Medical Technologies, Inc. letter to NRC, dated October 4, 2013, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Environmental Requests for Additional Information (ML13303A887)

(4) SHINE Medical Technologies, Inc. letter to NRC, dated June 16, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Revision to Sections 13b.3 and 19.4 of the Preliminary Safety Analysis Report Page 9 of 9