[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]



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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).

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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