DowElanco, Environmental Assessment: Finding of No Significant Impact and Notice of Opportunity for Hearing Related to Amendment of Material License Number 13-26398-01

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

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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]

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