[Federal Register Volume 66, Number 70 (Wednesday, April 11, 2001)]
[Notices]
[Pages 18817-18820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8890]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-32714]


Environmental Assessment: Finding of No Significant Impact, and 
Notice of Opportunity for a Hearing Related to Amendment of U.S. 
Nuclear Regulatory Commission Byproduct Materials, License 13-26398-01, 
Dow AgroSciences LLC

AGENCY: U.S. Nuclear Regulatory Commission (NRC).

ACTION: NRC plans to issue an amendment to NRC Byproduct Materials 
License 13-26398-01, authorizing use of carbon-14 (C-14) in field 
studies at the Dow AgroSciences Midwest U.S. Research Center located in 
Fowler, Benton County, IN.

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FOR FURTHER INFORMATION, CONTACT: Binesh K. Tharakan, Office of Nuclear 
Material Safety and Safeguards, Mail Stop T8F5, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555, Telephone (301) 415-7138, e-mail: 
[email protected].

Environmental Assessment

Background

    This environmental assessment (EA) is being performed to evaluate 
the environmental impacts of the proposed amendment to Dow 
AgroSciences' NRC Byproduct Materials License 13-26398-01, which would 
permit the use of radioactive materials in field studies at the Dow 
AgroSciences' field research station known as the Midwest U.S. Research 
Center (hereafter referred to as the Center). The Center is located at 
1736 N 1200 E in Fowler (Benton County), IN.
    In 1993 and again in 1996, this licensee (previously known as 
DowElanco) was approved for similar radiolabeled field studies at its 
former field research site known as the DowElanco Greenfield Field 
Research Station in Greenfield, IN. All radioisotope use ceased at the 
Greenfield Station and the site was decommissioned in 1998. Two 
previous Federal Register notices--58 FR 28638 and 61 FR 16937--
describe using radioactive materials to provide data for previous 
``nature-of-residue,'' ``uptake,'' and ``crop rotation'' field 
pesticide studies performed by this licensee. The purpose of the 
pesticide studies, which are similar to the requested studies, was 
explained in detail in each of these Federal Register notices. The 
field use of radiolabeled chemicals described for the proposed 
amendment (including study design, specific radioisotopes, amount used, 
and personnel training) is essentially unchanged from the previously 
licensed use at the Greenfield Station.

Proposed Action

    The proposed action is to amend NRC's Dow AgroSciences Byproduct 
Materials License No. 13-26398-01, which was originally issued to 
DowElanco on September 21, 1992, to allow a maximum of 1110 
megabecquerels (30 millicuries) of C-14 radiolabeled pesticides to be 
used in a year for outdoor agricultural field studies at the Center. 
The plots where the material will be used are described in the site 
characterization section of this document. The overall objective of 
these small plot field studies is to use radioactivity to identify the 
metabolic pathway for a given agrochemical after its application to a 
particular crop or to the soil in which the crop is grown. Once the 
metabolites have been isolated and structurally identified, it will 
then be possible to conduct non-radiolabeled studies, using large-scale 
field applications, to provide quantitative data on the metabolic 
residues found in the plants studied.

Need for the Proposed Action

    The U.S. Environmental Protection Agency (EPA) requires these 
Center studies so it can make regulatory decisions on the registration 
of biologically active chemicals as pesticides, according to the 
criteria set forth in the amended Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). The use of radiolabeled materials is 
specifically required, in 40 CFR 158.240 and 158.290, to determine: (1) 
the ``nature of residue'' in crops after treatment with a biologically 
active chemical; and (2) the ``uptake'' of a soil-applied, biologically 
active chemical by crops grown in the treated soil. The analytical 
sensitivity afforded through the use of radioisotope labels in field 
studies is essential for isolation and identification of metabolites 
present in trace amounts in complex biological matrices. In the absence 
of such radiolabeled molecules, it would be extremely difficult to 
trace, isolate, and identify a single chemical in these complex 
matrices. EPA specifically identifies the use of radiolabeled test 
materials, in 40 CFR 158.240, to determine the ``nature-of-residue'' 
studies; no alternatives are given. The current amendment request 
proposes to perform studies at the Center similar to the C-14 field 
studies that were performed at the Greenfield Research Station.
    These studies are being completed, as required by EPA, for 
registering the pesticide and permitting sale of the pesticide in the 
United States and abroad. Specifically, the Federal Food, Drug, and 
Cosmetic Act (as amended) requires pesticides intended for use on 
agricultural commodities to be registered by EPA under FIFRA (as 
amended).

Site Characteristics

    The Center's land is fully owned by Dow AgroSciences and, as 
private land, it does not have a U. S. Bureau of Land Management 
designation. It is located in rural agricultural Benton County, IN. The 
Center's location consists of the following legal description: NE\1/4\ 
of S 9, T 25 N, R 6 W; and E\1/2\ of N\1/4\ S 9, T 25 N, R 6 W; and 
S\1/2\ of SW\1/4\ Section 4, T 25 N, R 6 W. It is bordered on the north 
by privately owned farm land used for growing row crops. The eastern 
portion of the Center property is bordered by County Road 1200 E, a 
moderately traveled country road. To the south, the Center's property 
abuts privately owned farmland used for growing row crops. Jackmon 
Ditch (county drainage ditch) drains from south to north and divides 
the property into one-third and two-third sections, perpendicular to 
the south border, with field plots to the east of the ditch designated 
as E-1 through E-8, and those to the west as W-1 through W-6. The west 
border abuts private farmland used for growing row crops. Big Pine 
Creek drains from east to west and runs diagonally from northeast to 
southwest through the center of the approximate 0.32 square kilometers 
(80 acres) of the Center's property that lies north of

[[Page 18818]]

County Road 200 N. County Road 200 N separates the northern sector of 
the Center (i.e., field plots N-1 through N-4 and the area of the 
irrigation storage basin) from the remainder of the property (i.e., the 
E fields, W fields, and the building site).
    The Center is approximately 1.25 square kilometers (310 acres). The 
crop area covers 0.97 square kilometers (240 acres), whereas the non-
crop areas cover 0.28 square kilometers (70 acres), including a 0.026-
square-kilometer (6.5-acre) man-made basin used to contain irrigation 
water. There are approximately 0.029 square kilometers (7.25 acres) of 
apples and grapes. The buildings and lawn take up approximately 0.03 
square kilometers (7.5 acres) and the grassed alleys and ditch bank 
cover approximately 0.23 square kilometers (56 acres). Two areas within 
the borders of the Center will be designated for radiolabeled field 
studies. The northwest corner of section W-6 will be designated for 
radiolabeled row crop studies, and individually identified trees in the 
orchard area, N-1, may occasionally be used, as well. At any time, less 
than 1 percent of the land is designated for radiolabeled field 
studies.
    The Center is Class I and II capability agricultural land, 
according to the U. S. Department of Agriculture Soil Conservation 
Service. The site ecosystem is tilled farmland, and the property has 
been in agricultural production for as long as records have been kept 
in Benton County, IN. A geological investigation was made in 1997 when 
the present domestic water well was installed. The Center's soil 
consists of thick deposits of glacial origin. Extensive glaciers of 
Illinois and Wisconsin age covered this area during the Pleistocene 
period.
    The geographically closest human community to the Center is 
Otterbein, located approximately 16 kilometers (10 miles) to the south 
in Benton County, IN. The population of Otterbein is 1291 (1990 
Census). The population of Benton County is 9441 (1990 Census). The 
location of the maximally exposed individual is 450 meters (1475 feet) 
to the north of N1. The nearest farms (property line) are located 295 
meters (955 feet) to the west of W6 plot and 21.6 meters (70 feet) to 
the north of N1.

Endangered Species

    There are no Federally listed endangered species within Benton 
County, IN.

Historical, Archaeological, and Cultural Sites

    The Dow AgroSciences site is not situated on or near any registered 
historical, archaeological, or cultural site, according to the National 
Park Service registry, and the State of Indiana, Department of 
Resources, Division of Historical Preservation and Archaeology.

Environmental Impacts of the Proposed Action

    As stated above, the location of the closest human dwelling is 450 
meters (1475 feet) to the north of N1, and the maximum radioactivity 
released in 1 year will be 1110 megabecquerels (30 millicurie). Using 
this information, impacts on water supplies and the dose to the 
maximally exposed individual are assessed. The radiological impact from 
the performance of field studies with radiolabeled materials at the 
Center has been calculated using both EPA's SCREEN 3 (a Gaussian 
Dispersion model) and COMPLY models.

Impacts on the Food Chain

    The plants grown in radiolabeled studies will not be available for 
incorporation into the food chain. Test areas will be enclosed by a 
2.1-meter (7-foot) chain link fence, and wire mesh or bird netting will 
be used to restrict bird and small rodent access to grain crops. All 
plant material generated will be used for laboratory research purposes 
or disposed of as radioactive waste. All contaminated soil will be 
removed from the site after harvest and disposed of as radioactive 
waste. Because of the precautions taken during application, the 
physical barriers in place to prevent wildlife access, and the removal 
of all soil and plant materials at the conclusion of the study, it is 
reasonable to conclude that the radiolabeled plant material is unlikely 
to enter the food chain by either direct human ingestion or indirect 
animal ingestion.

Site-Specific Characteristics Affecting Surface Water and Ground Water

    The following profile of soil layers is provided by the domestic 
Well Log for the Center: 0-0.6 meters (0-2 feet) of topsoil; 0.6-11.7 
meters (2-38 feet) of clay; 11.7-14.5 meters (38-46 feet) of coarse 
sand and gravel; 14.5-16.7 meters (46-54 feet) of gray clay; and 16.7-
18.8 meters (54-61 feet) of coarse sand and gravel. The well is 
screened at 17.3-19.1 meters (56-62 feet). The underlying geography for 
the site does not include a principal aquifer.
    The fields at the Center are equipped with drainage tiles, spaced 
approximately 18-meters (60-feet) apart and 91-122 centimeters (36-48 
inches) deep. The tile system providing drainage for W6 slopes to the 
east and dumps into Jackmon Ditch, approximately 12.4 meters (40 feet) 
south of Co. Rd. 200 N, which eventually dumps into Big Pine Creek. The 
tile system providing drainage for the orchard (N1) flows west into a 
trunk line that flows south and dumps into Big Pine Creek. Big Pine 
Creek is supplied by runoff from farms and roadways both upstream and 
downstream from the Center, which would significantly dilute any 
contribution from the Center.

Results of Radioactive Monitoring During Similar Test at the Greenfield 
Station

    Dow AgroSciences will use the same application precautions, when 
applying radiolabeled pesticides at the Center, as were used during the 
Greenfield station applications. As a result of the precautions taken 
at Greenfield station during application of the radiolabeled test 
materials (e.g., 0.9-1.8-meter (3-6-foot)- wide sheets of plastic 
placed on the ground outside the plot borders during application; 
applications made only when wind speeds were 4.8 kilometers(3 miles) 
per hour; etc.), 100 percent of the applied radioactivity was initially 
accounted for on the soil and/or plants within the test plot. Since 
wood borders, extending 15.2 centimeters (6 inches) above the soil 
surface and 10.2-15.2 centimeters (4-6 inches) below surface, surround 
the immediate plot area, there was minimal chance for lateral movement 
of the applied radioactivity from runoff. Combustion analyses of soil 
samples collected from outside plot borders at the Greenfield station 
at the termination of each study conducted there confirmed that no 
radioactivity was ever found outside the plots. Based on those results, 
it is not anticipated that any of the applied radioactivity will be 
found in the soil outside of the test plots at the Center.
    Vertical movement of radioactivity in the soil column within a 
treated plot was monitored at the Greenfield site, to give an idea of 
the potential for movement of radioactivity into subsurface water. For 
most materials at the time the plots were remediated, the bulk of the 
applied radioactivity (75-90 percent) remained in the top 15.1 
centimeters (6 inches) of the soil profile, whereas most of the 
remaining residues were usually accounted for in the 15-30-centimeter 
(6-12-inch) segments. For more mobile compounds, small amounts of the 
total applied radioactivity (1-10 percent) were

[[Page 18819]]

sometimes observed in the 30-45-centimeter (12-18-inch) and 45-60-
centimeter (18-24-inch) segments. No significant levels of 
radioactivity were ever accounted for at depths below 60 centimeters 
(24 inches). These results indicated that radioactivity in typical 
study plots would not move deeply enough into the soil profile to get 
into ground water or be transported by the field tiles.
    The tile system would remove the majority of water that infiltrates 
the soil, minimizing that which enters the ground or well-water 
supplies. Periodic monitoring of water in the field tiles that drained 
the radioactive plot area at the Greenfield location showed no 
detectable radioactivity in the drainage water. Based on those results, 
use of similar field tile systems, and the fact that the similar soil 
type at the Center site is also considered to have a low vulnerability 
to leaching, it is not anticipated that any of the applied 
radioactivity will be found in the water from the plot area. Past 
radiolabeled tests at the Greenfield location showed only minimal 
amounts of radiolabeled material at a maximum depth of 45-60 
centimeters (18-24 inches) in the soil profile, and no radiolabeled 
material was ever found in ``grab samples'' collected from the field-
tile drainage water.

Ground-water Impacts

    Given these observations from the Greenfield station, the use of 
the same application precautions, use of similar wooden borders, 
similar soil types, and presence of a similar drainage field-tile 
system, it is not anticipated that any of the applied radioactivity 
will be found in the soil outside of the test plots, and it is not 
considered likely that radiolabeled material from the Center will 
contaminate ground water.

Surface-Water Runoff

    An unrealistic worst-case and bounding radiological assessment can 
be estimated based on a severe rainfall event that washes all the 
applied activity from the plant or soil. Since both the crop and the 
soil would be expected to contain radioactive pesticides or their 
metabolites, a release of all of the applied activity could occur only 
if both the crop and the soil were washed over the 15.1-centimeter (6-
inch) wooded border and away from the plot. The maximum activity to be 
used per application is 370 megabecquerels (10 millicuries), with a 
maximum per year, for the site, of 1110 megabecquerels (30 
millicuries).
    The 30-year average rainfall in the nine counties in the northwest 
district, including Benton County, is 96.2 centimeters (37.86 inches), 
usually evenly distributed over the course of the year. The greatest 
monthly rainfall from 1972 to 1996 occurred in June 1993, when 25.8 
centimeter (10.15 inches) were recorded. If 25.8 centimeters (10.15 
inches) of rain were to fall over the 70-meter by 70-meter (230-foot by 
230-foot) W6 research plot, where 1110 megabecquerels (30 millicurie) 
of C-14 had been applied, a volume of 1260 x 10 9 cubic 
centimeters [milliliters (ml)] of water would leave the plot as surface 
runoff. If 100 percent of an 1110-megabecquerels (30-millicurie) 
application were lost to surface runoff during this rainfall, the 
activity concentration of the surface runoff from the plot would be 
0.89 becquerel per ml (0.024 nanocurie per ml). This is below 1.11 
becquerel per ml (0.030 nanocurie per ml), the C-14 water-effluent 
limit in 10 CFR Part 20 (Appendix B, Table II, Column 2). This activity 
concentration lost to surface runoff would result in a dose of less 
than 0.5 millisievert (50 millirem) to a member of the public, if it 
were ingested continuously over an entire year.
    The plot runoff would be significantly diluted by the surface-water 
runoff from the rest of the Center and further diluted after it entered 
Big Pine Creek, which would also contain a large volume of runoff from 
the road and surrounding farms. It is reasonable to assume that 
significant dilution would occur and greatly reduce any potential dose 
to an individual off-site.

Dose to the Maximally Exposed Individual

    The EPA SCREEN model was used to estimate potential airborne 
concentrations of C-14 inhalation doses to the maximally exposed 
individual (i.e., the nearest resident located 450 meters (1475 feet) 
downwind from the test plot). This is a worst-case scenario, using 
unrealistically constant meteorological conditions and extremely 
conservative assumptions in the estimations. The scenario modeled 
assumed that the release of the maximum amount of C-14 applied in one 
year is 1110 megabecquerels (30 millicurie); that 100 percent of the 
applied C-14 is emitted as carbon dioxide; that there are constant 
meteorological conditions for the entire year [D-stability class during 
the day and F-stability class during the night, 1 meter per second (3.3 
feet per second) wind speed, and the wind direction is constant in the 
direction of the nearest resident]. Under these conditions, the annual 
average concentration resulting from the use of C-14 radiolabeled 
material at the Center would be 0.345 picograms per cubic meter(.345 
attograms per ml) of air. This corresponds to a worst-case and bounding 
air concentration of 0.056 microbecquerel per ml (0.0015 femtocurie per 
ml) at the receptor site and a maximum annual intake, by the maximally 
exposed individual, of 0.7 kilobecquerel (11 nanocuries). ]
    To put these values into perspective, they are compared with values 
in Part 20. The air concentration value is a small fraction of the Part 
20 limit,110000 microbecquerel per ml (300 femtocurie per ml), for 
carbon dioxide effluent release which, if inhaled continuously over the 
course of a year, would result in a total effective dose equivalent of 
0.5 millisievert (50 millirem). The annual intake value is a small 
fraction of the Part 20 annual limit on the intake value of 74 
megabecquerels (2 millicuries) which would result in a dose of 0.5 
millisievert (50 millirem). In fact, based on the estimated annual 
intake value determined from the EPA SCREEN model, the estimated dose 
to a member of the public is less than 0.0005 millisievert (0.0001 
millirem).
    The EPA COMPLY model was also used to evaluate the worst-case and 
bounding dose to the general public from all pathways, including 
inhalation, ingestion of contaminated food, immersion, and ground 
deposition. Again, the maximum activity of 1110 megabecquerels (30 
millicuries) of C-14 was assumed to be released in 1 year, at a 
distance of 450 meters (1475 feet) from the nearest residence. The 
COMPLY program calculated the maximum effective whole body dose for the 
maximally exposed individual to be 0.00069 millisievert per year (0.069 
millirem per year), an amount well below the NRC regulatory limit of 1 
millisievert (100 millirem) per year and EPA's clean air act 
concentration limit of 0.1 millisievert (10 mrem).
    Further evaluation of the offsite analysis was not considered 
necessary.

Alternatives to the Proposed Action

    As required by Section 102(2)(E) of the National Environmental 
Policy Act (NEPA) [(42 U.S.C. 4322(2)(E)], possible alternatives to the 
final action have been considered. One alternative to the field studies 
is the treatment of greenhouse-grown plants with the radiolabeled 
research chemical. A second alternative is not to perform the studies. 
However, these alternatives are not feasible for two reasons. First, 
not all plants can be grown successfully in a greenhouse. Second, EPA 
requires the C-14 field studies to be conducted at the Center.

[[Page 18820]]

The EPA-required studies must evaluate the behavior of agricultural 
chemicals under normal agriculture conditions.
    Dow AgroSciences is already authorized to conduct studies on 
greenhouse-grown plants with radiolabeled research chemicals at its 
Indianapolis research facility; however, this is not a viable 
alternative to collecting data generated by outdoor field studies. 
Greenhouse studies provide an unnaturally stable environment void of 
normal weathering field conditions, which traditionally leads to non-
representative metabolic profiles. Photolysis, heat, humidity, and 
other conditions influence the degradative processes that occur in the 
soil and on the plant surface. EPA requires the identities of the 
degradates formed as a result of these natural outdoor conditions.

Agencies and Persons Contacted

    NRC contacted Dow AgroSciences; the Bloomington, IN, field office 
of the U.S. Fish & Wildlife Service; the National Park Service 
Registry; the State of Indiana, Department of Resources, Division of 
Historical Preservation and Archaeology; and the State of Indiana, 
Department of Health, Indoor & Radiological Health Division. The U.S. 
Fish & Wildlife Service provided information regarding Federally listed 
endangered species. The National Park Service Registry and the State of 
Indiana, Department of Resources, provided information on registered 
historical and archaeological sites. The State of Indiana, Department 
of Health, Indoor & Radiological Health Division agrees with the 
proposed action and has no additional comments.

References

    1. Letter dated September 10, 1999, from Dow AgroSciences to 
U.S. NRC Region III, Lisle, IL, requesting amendment of Byproduct 
Materials License Number 13-26398-01.
    2. Letter dated May 3, 2000, from Dow AgroSciences to U.S. NRC, 
Washington, DC, providing clarification to the amendment request.
    3. Federal Register notice, Volume 58, pages 28638-28645, 
``Environmental Assessment, Finding of No Significant Impact, and 
Notice of Opportunity for a Hearing Related to Amendment of 
Byproduct Materials License 13-26398-01, DowElanco,'' Washington, 
DC, 1993.
    4. Federal Register notice, Volume 61, pages 16937-16940, 
``DowElanco, Environmental Assessment: Finding of No Significant 
Impact and Notice of Opportunity for Hearing Related to Amendment of 
Byproduct Materials License Number 13-26398-01,'' Washington, DC, 
1996.
    5. Ground Water Atlas of the U.S., Segment 10, Hydrogeological 
Investigations Atlas 730-K, U.S. Geological Survey, 1995.

Finding of No Significant Impact

    Pursuant to 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 use 
of C-14 in field studies at the Dow AgroSciences' Midwest U.S. Research 
Center located in Fowler, Benton County, IN. Accordingly, the 
preparation of an Environmental Impact Statement is not required for 
the amendment to Byproduct Materials License 13-26398-01, which will 
authorize the use of C-14 in field studies at the Center. This 
determination is based on the foregoing EA performed in accordance with 
the procedures and criteria in Part 51, ``Environmental Protection 
Regulations for Domestic Licensing and Related Regulatory Functions.''
    The Dow AgroSciences amendment request and related documents are 
available for inspection and copying for a fee in the Region III Public 
Document Room, 801 Warrenville Road, Lisle, IL 60532-4351. The 
documents may also be viewed on the Agency-wide Documents Access and 
Management System located on the NRC website at www.nrc.gov

Notice of Opportunity for a Hearing

    Any person whose interest may be affected by the issuance of this 
action 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 the publication of 
this notice in the Federal Register; be served on the NRC staff 
(Executive Director for Operations, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852), and on the licensee (Dow 
AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054); 
and must comply with the requirements for requesting a hearing set 
forth in the Commission's regulations, 10 CFR Part 2, Subpart L, 
``Information Hearing Procedures for Adjudications in Materials 
Licensing Proceedings.''
    These requirements, which the request must address in detail, are:
    1. The interest of the requestor in the proceeding;
    2. How that interest may be affected by the results of the 
proceeding (including the reasons why the requestor should be permitted 
a hearing);
    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 hearing is 
timely--that is, filed within 30 days of the date of this notice.
    In addressing how the requestor's interest may be affected by the 
proceeding, the request should describe the nature of the requestor's 
right under the Atomic Energy Act of 1954, as amended, to be made a 
party to the proceeding; the nature and extent of the requestor's 
property, financial, or other (i.e., health, safety) interest in the 
proceeding; and the possible effect of any order, that may be entered 
in the proceeding, on the requestor's interest.

    Dated at Rockville, Maryland, this 5th day of April, 2001.

    For The Nuclear Regulatory Commission.
John W. N. Hickey,
Chief, Material Safety and Inspection Branch, Division of Industrial 
and Medical Nuclear Safety, Office of Nuclear Material Safety and 
Safeguards.
[FR Doc. 01-8890 Filed 4-10-01; 8:45 am]
BILLING CODE 7590-01-P