[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
