[Federal Register Volume 61, Number 76 (Thursday, April 18, 1996)] [Notices] [Pages 16937-16940] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-9539] ======================================================================= ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION [Docket No. 030-32714] DowElanco, Environmental Assessment: Finding of No Significant Impact and Notice of Opportunity for Hearing Related to Amendment of Material License Number 13-26398-01 ACTION: The U.S. Nuclear Regulatory Commission (NRC) is considering an amendment to NRC License No. 13-26398-01, for continued use of carbon- 14 (C-14) in pesticide testing at the DowElanco Greenfield Field Research Station (Greenfield, Indiana). ----------------------------------------------------------------------- FOR FURTHER INFORMATION CONTACT: Susanne Woods, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, MS T8F5, Washington, DC 20555, telephone (301) 415-7267. Environmental Assessment Description of the Proposed Action The proposed action is to amend NRC Byproduct Material License No. 13-26398-01, issued to DowElanco on September 21, 1992, and amended on May 14, 1993. Pursuant to the 1993 amendment, the license presently authorizes DowElanco personnel to complete the following: (1) use byproduct material at the DowElanco Indianapolis Research and Development Site (Zionsville Road, Indianapolis, Indiana); and (2) conduct C-14-labeled pesticide studies, during 1993, on small, controlled, outdoor, test areas at the DowElanco Greenfield Field Research Station (Greenfield, Indiana) (hereafter referred to as the Station). The proposed NRC license amendment will authorize DowElanco personnel to continue to use C-14 in pesticide studies, using the same methods, control areas, and small test plots examined during the environmental assessment (EA) process that accompanied the 1993 amendment authorization for field studies at the Station. Authorization granted by the proposed amendment will be in effect until the next license renewal, at which time the environmental impacts will again be examined and assessed as deemed necessary. The EA and Finding of No Significant Impact (FONSI) for the proposed action, presented herein, accompanies the proposed amendment and, as will be discussed, encompasses a period of time that is expected to exceed the date of the next license renewal (i.e., a period that also exceeds the duration of the proposed amendment to the license and assumes many years of DowElanco ownership and use of the Station for the required C-14 studies). The purpose of the pesticide studies was further explained in NRC's ``Environmental Assessment: Finding of No Significant Impact and Notice of Opportunity for Hearing Related to Amendment of Material License 13-26398-01, DowElanco,'' published prior to the 1993 studies in the Federal Register (FR) on May 14, 1993 (58 FR 28638). The non-site-specific aspects of the C-14-labeled pesticide studies continue to be performed under DowElanco's current authority, as provided in NRC License No. 13-26398-01 (e.g., possession of C-14 before application; preparation of C-14-labeled pesticides; use and subsequent laboratory analysis of C-14 in soil and plant samples; disposal of waste consisting of radioactive material; and compliance with regulatory requirements for C-14 use and bioassay). Background As stated in the 1993 EA (58 FR 28638), the Vice President of DowElanco Research and Development requested an NRC license (application dated March 6, 1992). The request included authorization to perform C-14-labeled pesticide research and registration studies on plants growing in a farm and orchard environment at the Station. DowElanco manufactures and develops a variety of chemicals for agricultural use, including pesticides (i.e., insecticides, fungicides, and herbicides) for treating ornamental plants, food crops, and feed crops. The exploratory research studies are conducted to examine the fate of pesticides in and on various plant species. The studies are being completed, as required by the U.S. Environmental Protection Agency (EPA), for registering the pesticide and permitting sale in the United States and other countries. Specifically, pesticides intended for use on agricultural commodities must be registered by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (as amended), as required by the Federal Food, Drug, and Cosmetic Act (as amended). DowElanco requested the following three types of field studies using C-14: two specific types of pesticide field studies for registration with the EPA, requiring use of C-14-labeled pesticides in an outdoor environment (referred to as the nature-of-the-residue and confined-rotational-crop studies); and lysimeter studies to augment the EPA studies. Further, DowElanco anticipates that open-field (i.e., outdoor) C-14 pesticide studies will be conducted at [[Page 16938]] the Station for the duration of the license. Individual trees or plots may continue to be used to study the effects from a particular pesticide application, for periods lasting from a few weeks up to 18 months. DowElanco will limit the amount of C- 14 applied at the Station to 370 Megabecquerel (MBq) [10 millicuries (mCi)], during any 24-hour period. Further, DowElanco will apply no more than 1,110 MBq (30 mCi) of C-14 at the Station, in a calendar year. As specified for the 1993 EA, DowElanco personnel will follow specific procedures to contain the C-14 to the study plots or specific trees and branches, as well as monitor and maintain established C-14 levels in surface water, subsurface water, and soil. Assessment of the Environmental Impacts of the Proposed Action Many of the environmental impacts for the proposed action were previously analyzed in the EA prepared for the 1993 license amendment (58 FR 28638). Information and analyses previously presented include: (a) site location and geology; (b) studies to be performed; (c) need for the proposed action (proposed studies); (d) affected environment; (e) study protocols; (f) pathways to the environment; (g) pathways to humans; (h) effects on other species; and (i) alternatives to the proposed action (proposed studies). Specific aspects of the studies for the current licensing action (e.g., site, plants, pesticides, application, and soil/water clean-up procedures) are the same as those described in the 1993 EA. Additionally, the C-14 will continue to be released into the environment as a tracer for labeling the studies. Unlike the 1993 EA, however, the proposed action, described herein, involves a greater duration of study. Accordingly, this EA included consideration of possible impacts from the increased quantity of C-14 introduced into the environment. The FONSI for this EA forms a basis for authorizing continuation of the studies at the Station. To ensure that all relevant impacts are considered for continuation of the studies (i.e., the current licensing action), discussions of impacts are either referenced (as noted above) from the previous notice (58 FR 28638) or provided herein. As described in the 1993 EA (58 FR 28638), the C-14-labeled studies are limited to one field (designated as Block 10), as the site for lysimeter and open-field C-14 crop studies, and one orchard (designated as Block 3). In turn, applications of the labeled pesticides will be limited to individual trees and/or branches for Block 3 studies and individual subplots for Block 10 studies. (Before NRC-licensed material can be used in any other field/orchard application outside of Blocks 3 or 10, a new EA must be completed for a new license amendment.) As specified in the 1993 EA, members of the general public (i.e., individuals other than DowElanco personnel working at the Station or Eli Lilly and Company security personnel responsible for providing Station surveillance) are not expected to come into direct contact with the C-14, pesticide, study plots, or vegetation. Impacts to the Human Environment The potential impact to the human environment from the proposed studies were evaluated by NRC using two different methodologies (as implemented in computer codes) for assessing radiation doses delivered to individuals living either on the study site (i.e., the Station) or offsite. Onsite impacts from all possible pathways for delivering dose to humans were assessed using the RESRAD code (implementing the U.S. Department of Energy guidelines for residual radioactive material) (Yu, C., et al., 1993). Surface-water and groundwater pathways were identified as the relevant pathways for delivering radiation doses offsite. Offsite water pathways were assessed using the MEPAS code (Multimedia Environmental Pollutant Assessment System) (Droppo, J.G., Jr., et al., 1989). Specifically, the dose assessments examined a maximum C-14 application of 1,110 MBq (30 mCi) per year at the Station, with DowElanco's soil and surface water residual contamination (i.e., remediation levels after removal of test plot vegetation and soil) set at 1.11 Bq/gram(g) [30 picocuries(pCi)/g] and 851 Bq/l (23,000 pCi/l), respectively. Existing contamination, resulting from the studies authorized by the 1993 license amendment, was considered in the current assessment. Site-specific parameters were established, using conservative assumptions, for modeling in both the RESRAD and MEPAS assessments. The RESRAD analysis (onsite impact analysis), assumed a family-farm scenario where radiation exposure (C-14) to residents of the farm results from all pathways [i.e., external radiation exposure and internal radiation exposure via ingestion (water, crops, livestock, vegetation, fish, milk, and soil) and inhalation]. Additionally, the first sand and gravel layer [13.7-36.6 meters(m) {45-120 feet(ft)}] was assumed to be the upper-most aquifer, with the shallowest depth [13.7 m (45 ft)] as the depth representing the top of the screened interval for the family drinking-water well. The contaminated topsoil and the aquifer were separated by an unsaturated, uncontaminated, 13.1-m-thick (43-ft-thick), clay layer. The modeled site was assumed to be a plot of ground, equal in size to Block 10, and contaminated with 1.11 Bq/g (30 pCi/g) of C-14 throughout the entire layer of topsoil [0.61-m (2-ft) deep] above the clay layer (without cover or controls). The offsite scenario assessed the pathway established via overland transport of the site surface water, which was assumed to drain immediately into Wilson's ditch. For the modeled scenario, the ditch was conservatively assumed to border the study block and empty into a receptor well (drinking water) at 183 m (600 ft) downstream from the Station. (The actual locations of the ditch and pathway of the water in the ditch are at greater distances from the site.) For both the offsite and onsite assessments, the existing tile drain field for the Station was considered inoperable, allowing all infiltrating water to eventually encounter the upper-most aquifer (i.e., the drinking water supply below the soil surface). The maximum total effective dose equivalent (TEDE) indicated for an individual living onsite, using the family-farm scenario, was 17 microsieverts [1.7 millirem (mrem)] per year and occurs via water- independent pathways (i.e., pathways that do not result from water as the medium of transport for the C-14 from the soil to humans) during the first year of the model. Hence, the maximum dose does not exceed the 1 millisievert (mSv) (100 mrem) per year (TEDE) public dose limit established in 10 CFR Part 20. This annual dose rapidly reduces after the first year and reaches zero after approximately 20 years. By comparison, assessment of primarily water-dependent pathways (i.e., water is the medium of transport for C-14), using the family-farm scenario, indicates that this pathway, alone, would deliver a maximum 15 microsievert (1.5 mrem) per year dose (TEDE) at approximately 15 years into the family-farm model. With specific regard to groundwater, computer modeling predicted that a peak dose of 0.26 microsievert/yr (0.026 mrem/yr) from ground water at the site is possible at 10.92 years, with a C-14 concentration of 0.625 Bq/l (16.9 pCi/l) of water. Offsite impacts were calculated using a maximum lifetime exposure (70 years). The analysis indicated an individual's peak lifetime exposure will [[Page 16939]] be 0.29 mSv (29 mrem) (TEDE) from the groundwater pathway at approximately 500 years into the model, with a peak groundwater concentration of C-14 in year 486. Overland transport to offsite surface water was calculated to result in an expected individual peak lifetime dose of 0.13 microsievert (13 microrem), with a peak water concentration in year 117. The yearly average TEDE for an individual, based on a 70-year exposure period, will be approximately 4 microsieverts (0.4 mrem) and 0.002 microsievert (0.2 microrem), for the groundwater and surface water pathways, respectively. These models assume the tile drainage system to be inoperable. However, the system will presumably remain operable during the licensed period of the site (to prevent flooding and costly destruction to vegetation and research analyses). Although the drain system has the potential to collect C-14 that does not escape the soil by other means of transport, effluent from the drainage system will be monitored to determine compliance with 10 CFR Part 20. During operation, air releases of C-14 are expected at the Station. DowElanco completed analysis of these releases using the COMPLY analysis computer code developed for EPA. NRC review of the analysis determined that conservative estimates were used for various site parameters. Further, the COMPLY code resulted in a dose of less than 10 microsieverts (1 mrem) to an individual living 244 m (approximately 267 yards) from the site. Further evaluation of the offsite analysis was not considered necessary. Endangered or Threatened Species During this EA, DowElanco forwarded a listing of ``Endangered, Threatened, and Rare Species of Hancock County, Indiana,'' assembled by the Indiana Natural Heritage Data Center from reports of individual observations (the Station is in Hancock County). The listing includes a number of mammals, birds, mussels, and plants that do not appear on the Federal listing of endangered species. The names of two species appearing on the Hancock County listing, the Indiana bat (Myotis sodalis) and the clubshell (Pleurobema clava), also appear on the Federal listing of endangered species. The clubshell habitat is the clean swept sand and gravel existing in rivers. The species feeds and respires by filtering water. The larval stage of the clubshell reproductive cycle depends upon attachment to, and nourishment from, a fish host. As of 1993, the club- shell was known to exist in two Indiana Rivers--the Tippecanoe River (Kosciusko, Fulton, Pulaskia, and Tippecanoe Counties, Indiana); and Fish Creek of the St. Josephs River (DeKalb County, Indiana, and Williams County, Ohio) (Tolin, 1993, 58 FR 5638). At the Station, surface water and tile drainage from Blocks 3 and 10 drain into Little Sugar Creek, approximately 11 to 16 kilometers (7 to 10 miles) from the Station, via Wilson's Ditch. Water is not always present in Wilson's Ditch. Hence, the ditch is not expected to support the aquatic life cycle of the clubshell. Water carrying C-14 from Blocks 3 and 10 is expected to be significantly diluted with other surface water and tile drainage leaving the other areas of the Station and additional offsite locations, before being transported the distance to Little Sugar Creek. Additionally, carbon-dioxide gas dispersion from the transported water and siltation are examples of ways in which C-14 may depart the water pathway over this distance. Based on the aforementioned analyses, offsite radiation doses delivered to a clubshell population in Little Sugar Creek (or subsequent waterways receiving Station water), should such a population exist, are not expected to have a significant impact on members of the species. The Indiana bat population hibernates in caves through the winter months in only several, large aggregates. Few caves provide the cool, stable temperatures the species requires during hibernation. Disturbance during hibernation can cause a bat to expend 10 to 30 days of its otherwise conserved fat supply (Clawson, 1987). Natural catastrophe, vandalism, cave commercialization, or other human disturbance at one cave can destroy a substantial portion of the overall population directly or indirectly, by altering the cave microclimate. The species was placed on the Federal listing because of this vulnerability associated with its hibernating behavior. Female Indiana bats and their young live in nurseries. Migrating bats leave the midwestern caves beginning in late March and return in August (the time period of C-14 application and crop growth at the Station). Roosting begins again in approximately November. Just before roosting, the Indiana bat is likely to increase its body weight by up to 50 percent from consuming insects available in the vicinity of the cave (Humphrey and Sylvia, 1978). No caves are known to be in the vicinity of the Station. Some maternity roosts have been located along natural water banks, in floodplain forests, and behind loose bark in a tree hollow. Bats use mature trees as one of their summer habitats, for both roosting and foraging near the treetops. As insectivors, the Indiana bat consumes numerous types of insects, preferring moths (Lepidoptera), beetles (Coleoptera), flies, and midges (Diptera) (Clawson, 1987). Mature trees are not used in Blocks 3 and 10 at the Station. Additionally, C-14-labeled insecticide applied to specific tree areas will, presumably, decrease or eliminate insects available for any bats foraging in such study trees. The C-14 pesticide is applied in a controlled manner to a single limb or larger portions of a tree. After pesticide application, the area is covered with netting; hence, the access bats may have to the C-14-labeled pesticide is limited. Additionally, much of the vegetation at the Station will be harvested by November. Thus, a bat's possible intake of C-14 is further limited during the period when maximized retention of C-14 is estimated to affect approximately 50 percent (or less) of an individual bat's collected body mass. Given the information available and a hypothetical scenario in which an Indiana bat ingests contaminated insects or comes into contact with the C-14 through some other means, the possible radiation dose received is not expected to have a significant impact. Agencies and Persons Contacted Greg E. Socha, the Radiation Safety Officer for DowElanco, provided clarifying information. Additionally, NRC consulted J. Ruyack, Director of Indoor and Radiological Health for the Indiana State Department of Health, in a letter dated February 23, 1994. The letter explained this EA effort, stated NRC's intent to publish the findings in the Federal Register, and requested comments, concerns, or other information believed necessary to be considered during the assessment process. The letter was followed by a telephone call (April 11, 1994) in which it was established that no additional information, comments, nor concerns were identified. Finding of No Significant Impact Pursuant to the National Environmental Policy Act of 1969 (NEPA) and the Commission's regulations in 10 CFR Part 51, the Commission has determined that there will not be a significant effect on the quality of the human environment resulting from the continued use of C-14 in pesticide studies conducted at the Station. Further, an environmental impact statement is not required for the proposed amendment to Byproduct Material License No. 13-26398-01, which will authorize continuation of C- [[Page 16940]] 14-labeled pesticide studies at the Station. This determination is based on the foregoing EA performed in accordance with the procedures and criteria in 10 CFR Part 51, ``Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.'' The EA described herein confirms the Finding of No Significant Impact for the studies authorized at the Station by the 1993 license amendment. For further details of this action, see the license application dated March 6, 1992 (License Number 13-26398-01), and other related correspondence. Details of the impact analyses completed are available for both the RESRAD and MEPAS computer code evaluations. The documents (in Docket No. 030-32714) may be examined or copied for a fee, in the NRC's Region III Public Document Room, 801 Warrenville Road, Lisle, IL 60532-4351. References 1. Brack, Virgil, Jr., ``Hibernacula of the Endangered Indiana Bat in Indiana,'' Proceedings of the Indiana Academy of Science (1983) Vol. 93, pp. 463-468. Clawson, Richard L., ``Indiana Bats: Down for the Count,'' BATS, (1987) Vol. 5, No. 2, pp. 3-5. 2. Droppo, J.G., Jr., et al. Multimedia Environmental Pollutant Assessment System (MEPAS) Application Guidance, PNL-7216, Pacific Northwest Laboratory, Richland, WA, 1989. 3. Howe, D.B., U.S. Nuclear Regulatory Commission. ``Environmental Assessment: Finding of No Significant Impact and Notice of Opportunity for Hearing Related to Amendment of Material License 13-26398-01, DowElanco,'' Federal Register, Washington, D.D., Vol. 58, pp. 28638-28645, 1993. 4. Humphrey, Stephen R. and Sylvia J. Scudder, Florida State Museum. Rare and Endangered Biota of Florida, Volume One: Mammals, University Press of Florida, Gainesville, FL, pp. 3 and 4, 1978. 5. Tolin, William A., U.S. Fish and Wildlife Service, ``Endangered and Threatened Wildlife and Plants; Determination of Endangered Status for the Northern Riffleshell Mussel (Eploblasma torulosa rangiana) and the Clubshell Mussel (Pleuroblema clava),'' Federal Register, Washington, D.C., Vol. 58, pp. 5638-42, 1993. 6. Yu, C., et al., Manual for Implementing Residual Radioactive Material Guidelines Using RESRAD, Version 5.0, ANL/EAD/LD-2, Argonne National Laboratory, Argonne, IL, 1993. Notice of Opportunity for a Hearing Any person whose interest may be affected by the issuance of this amendment may file a request for a hearing. Any request for hearing must be filed with the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, within 30 days of publication of this notice in the Federal Register and must be served on the NRC staff by mail addressed to the Executive Director for Operations, U.S. Nuclear Regulatory Commission, Washington, DC 20555 or by delivery to the Executive Director for Operations, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852; and must be served on the applicant by mail or delivery to DowElanco, Building 306, 9410 Zionsville Road, Indianapolis, Indiana 46268. The request for a hearing must comply with the requirements set forth in the Commission's regulations, 10 CFR Part 2, Subpart L, ``Informal Hearing Procedures for Adjudications in Material Licensing Proceedings.'' Subpart L of 10 CFR Part 2 may be examined or copied for a fee in the Commission's Region III Public Document Room at 801 Warrenville Road, Lisle, Illinois 60532-4351, or in the NRC Public Document Room, 2120 L Street, N.W., Lower Level, Washington, DC 20555. As required by 10 CFR Part 2, Subpart L (10 CFR 2.1205), the request for hearing must describe in detail: (1) the interest of the requestor in the proceeding; (2) how that interest may be affected by the results of the proceedings, including the reasons why the requestor should be permitted a hearing, with particular reference to the factors set out in paragraph (g) of 10 CFR 2.1205; (3) the requestor's areas of concern about the licensing activity that is the subject matter of the proceeding; and (4) the circumstances establishing that the request for a hearing is timely in accordance with paragraph (c) of 10 CFR 2.1205. The factors in 10 CFR 2.1205(g) that must be addressed in the request for hearing include: (1) the nature of the requestor's right, under the Atomic Energy Act of 1954, to be made a party to the proceeding; (2) the nature and extent of the requestor's property, financial, or other interest in the proceeding; and (3) the possible effect of any order that may be entered in the proceeding, upon the requestor's interest. Dated at Rockville, Maryland this 11th day of April, 1996. For the U.S. Nuclear Regulatory Commission. Larry W. Camper, Chief Medical, Academic, and Commercial Use Safety Branch, Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards. [FR Doc. 96-9539 Filed 4-17-96; 8:45 am] BILLING CODE 7590-01-P