xvEPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
December 1998
Reregist ration
Eligibility Decision (RED)
1,3-Dichloropropene
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oEPA
United States
Environmental Protection
Agency ..
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-98-014,
December 1998
R.E.D. FACTS
1,3-Dichloropropene
Pesticide
Reregistration
Use Profile
All pesticides sold or distributed in-the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
.registered before November 1, 1984, be reregistered to ensure that they meet
today's.more stringent standards.
- In evaluating pesticides for reregistratibn, EPA obtains and reviews a
complete set of studies from pesticide producers and uses these data to v
evaluate the human health and, environmental effects of each pesticide,
including aggregate exposures from all sources of pesticide residues, whether
infantsrand children have heightened susceptibility to pesticide residues, and
whether there are cumulative effects of pesticides and other compounds with a
common mechanism of toxicity. The Agency develops any mitigation
measures or regulatory controls needed to effectively reduce each pesticide's
risks. EPA then reregisters those pesticides that can be used without posing
unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for
its decision in a Reregistration Eligibility Decision (RED) document. This fact
sheet summarizes the information in the RED document for reregistration case
0328, 1,3-Dichioropropene (1,3-D or trade name Telone).
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1,3-D is a pre-plant soil fumigant used to control nematodes and is
registered for use on soils to be planted to all crops. Combining chloropicrin
with 1,3-D increases herbicidal and fungicidal properties. The registrant, Dow
AgroSciences, is also developing a formulation to be applied in drip irrigation
systems as a pre-plant soil fumigant. 1,3-D use is restricted to certified
applicators and is applied using specialized tractor-drawn rigs which inject 1,3-
D 12" to 18" beneath the soil surface. Soil sealing after application is required,
and is accomplished by compacting the top layer of soil,'applying a water seal,
or using tarps. The 1,3-D labels require handlers to wear respirators (except
for a limited exception for applicators in enclosed cabs) The labels also
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Regulatory
History
Human Health
Assessment
stipulate a 300 foot no-treatment buffer from occupied buildings to reduce
risks to residents wKo live near treated fielcls and will require as of
August 1, 1999 a 100 foot no-treatment buffer from drinking water wells.
The registrant suggests a waiting period (a week for every 10 Ibs. 1,3-D
applied) before planting any crops due to phytotoxicity.
The Agency expects 1,3-D use to increase as it replaces certain methyl
bromide soil fumigant uses. Methyl bromide is being phased out under the
Clean Air Act and the Montreal Protocol because it has been identified as an
ozone depletor. Methyl bromide is a soil fumigant used primarily on
ornamentals and higher-value fruit and vegetable crops (e.g.,strawberries,
tomatoes). Currently, the highest methyl bromide soil fumigation use occurs in
Florida and California.
1,3-D was first registered as a pesticide in the U.S. in 1954. EPA issued
a Registration Standard for 1,3-D in October 1986, as well as an
October 8, 1986 Federal Register notice announcing a Special Review of
1,3-D based on cancer concerns for workers. An October 1986 Data Call-in
(DCI) required additional residue chemistry, inhalation exposure, and
environmental fate data.
1,3-D labels were modified in 1992 and again in 1996 to include
measures to minimize exposures to workers and for residents who live near
treated fields. The Worker Protection Standard (WPS) requirements for
1,3-D were included in those label changes. On September 30, 1998, Dow
AgroSciences requested additional modifications (see the section titled
"Product Labeling Changes Required"), which will take effect August 1, 1999.
Currently, there are ten 1,3-D products registered to three companies.
There are also three Special Local Needs (or FIFRA section 24(c) registrations
for products containing 1,3-D.
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Toxicity
In studies using laboratory animals, 1,3-D generally has been shown to
be of moderate acute toxicity by the oral and dermal routes and has been
placed in Toxicity Category IE (the second highest of four categories) for these
effects.
1,3-D is not considered to be a developmental toxicant,, though it does
have some mutagenic properties. EPA has classified 1,3-D as a B2, possible
human, carcinogen By Both the inhalation and oral routes of exposure. This
classification is based on adrenal, liver, forestomach, thyroid, mammary and
lung tumors in both rats and mice by both routes of exposure.
Dietary Exposure
Studies developed for reregjstration show no residues in crops grown in
1,3-D-treated soils. The Agency has classified 1,3-D as a non-food use
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pesticide and thus no tolerances or exemptions from the requirement of a
tolerance are required. Because there are no tolerances, no tolerance
reassessment was included in this reregistration action, nor are there conflicts
with the CODEX international maximum residue levels. ,
Other studies Conducted for reregistration show that 1,3-D can make its
way to ground water under use allowed by 1,3 -D labels, where it may pose '
risks for residents who obtain their drinking water from wells hi the vicinity of
treated fields. Thus the dietary assessment is based on exposures to 1,3-D in
ground water. . .
The dietary assessment also includes exposures to two degradates of
tpxicological concern: 3-chloroallyl alcohol and 3-chloroacrylic acid. EPA
does not have data for a full assessment of the toxiciry of these degradates and
thus assumed lexicological and carcinogenic equivalency to the parent.
Occupational and Residential Exposure
1,3 -D is inj ected into the soil as a liquid which then quickly volatilizes
through the soil profile, some of which moves up into the atmosphere. Based
on current use patterns, handlers (loaders and applicators) may be exposed to
"1,3-D during and after normal use. Since 1992, the 1,3-D labels have been
modified to include engineering controls (closed loading, equipment to shut off
1,3-D flow at row turns, and Soil sealing), personal protective equipment
(respirators and chemical-resistant protective clothing) and other controls (5-
dayREI).
Residents who live near treated fields may also be exposed to volatilized
1,3-D which enters the atmosphere during the two week period following
application. Some of the label measures mentioned above were also designed
to minimize 1,3-D levels that volatilize after application, and thus serve to also
reduce residential exposures as well. In addition, lowered application rates and
a 300 foot no-treatment buffer on 1,3-D labels reduce residential exposures.
Residents who live near treated fields can also be exposed through
drinking water. A prospective ground water study conducted in Florida has
shown 1,3-D and degradate levels of concern in ground water, due mainly to
permeable soils and shallow water tables. A ground water study conducted in
Wisconsin showed even higher concentrations of 1,3-D where soils are
permeable and water tables shallow, suggesting cold areas are even more
vulnerable to ground water contamination since 1,3-D degradation is slower
under colder conditions.
Human Risk Assessment
1,3-D generally is of moderate acute toxicity. For chronic non-cancer
effects, anticipated residues (from drinking water) for the overall U.S.
population represents less than one percent of the Reference Dose (RfD), or
amount believed not to cause adverse effects if consumed daily over a 70-year
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lifetime. Based on results from the Florida study, the most highly exposed
Subgroup of non-nursing infants less than one year old has an anticipated
residue contribution which represents less than one percent of the RfD. This
fraction of the allowable RfD below 100 is considered to be an acceptable
dietary exposure risk.
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The Agency also assessed the risk resulting from chronic 1,3-D
exposures to occupational handlers. The NOEL for inhalation exposure is
0.091 mgZL (from the 2-year chronic rat study). EPA assessed risks to
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handlers using Margins of Exposure (MOE's). The MOE is a ratio of the
NOEL to the estimated daily exposure. EPA generally is not concerned with
MOE's greater than or equal to 100. The MOE's for 1,3-D, which were in the
560 to 1960 range, are acceptable.
EPA classifies1,3-D as a Group 62, probable human, carcinogen by
both the inhalation and oral routes of exposure. In January of 1998, Dow
. AgroSciences submitted new information to support regulating 1,3-D as a non-
linear carcinogen (i.e. that below a certain level of exposure, there is no cancer
risk)- EPA is scheduling a review of this information for 1999, however, will
not reassess 1,3-D cancer risks until all EPA policies on regulating non-linear
carcinogens are in place.
Dietary Risk - Because exposure through foods grown on treated soils is
not expected, dietary risk is assumed to be solely from drinking 1,3-D residues
in ground water. The Agency assessed the results from prospective ground
water mdnitoring studies, which were conducted in Florida and Wisconsin and
* thought to represent vulnerable sites for ground water contamination. EPA
based the'123-D risk assessment on levels found in on-site wells, although all
1,3-D labels as of August 1, 1999 will require a 100' no-treatment setback from
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From the Wisconsin site, levels (1,3-D plus degradates) found in on-site
- wells were associated with risk estimates at 10"3, For the general population,
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From the Florida site, which was used to estimate risks for ithe general
population, cancer risk estimates (1,3-D plus degradates) from wells located
within the field were approximately 4 x 10"6. The prospective studies were not
designed to assess risks from wells located away from treated fields and thus
''; .';;EPA,,Ra|mpt;i,tluantify risks with the 100' setback, though the levels found 100
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}'$![;; if !| t.'' ig,; :,',",,. i,;"' iv;.' i.,;, i,.: -^ [' \.,, '.feet, off-site were .fbout 15 times Jower.thanthpse found in on-site wells.
Therefore, the risk estimates for exposure to 1,3-D through drinking water are
considered to overestimate risk.
Worker Risk - Inhalation For workers, cancer risk estimates are in the
IQ~5, to 10"6 range, taking into account certain personal protective equipment
and engineering controls. Under EPA's Worker Risk Policy, the Agency
considers risks of W6 or lower not to be of concern and carefully examines
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risks in the range of W4 to W6 to seek ways of reducing risks prior to
reregistration. The 1,3-D labels have been modified to include label measures,
such as soil sealing, lowered rates, soil moisture and deeper injection, which
are expected to reduce worker risks, although the mitigation value could not be
quantified. EPA considers worker risk to have been adequately mitigated.
Residential Risk - Inhalation For residents who live at the 300 font
buffer, risk estimates are 6 x 10"6, however, this estimate does not include the
full value of mitigation measures listed above and is conservative in the
assumption that a person would spend 16 hours a day at 300 feet from the
treated field during the two-week period following fumigation when 1^,3-D.!
volatilization occurs for 30 years.
Uncertainties in the Risk Assessment - In addition to"the uncertainties
discussed above, there were numerous uncertainties in the studies used to
assess exposures. The largest source of uncertainty was trying to conduct
monitoring studies for a highly volatile chemical. Under normal use conditions,
there are a variety of uncontrollable environmental factors that ultimately affect
an individual's exposure. The limited number of monitoring sites also
contributed to the uncertainty related to EPA's risk estimates. Nonetheless,
EPA believes that these studies provide the best information for conducting the
., ; 1,3-D risk assessment.
Aggregate Risk for the General Population - EPA has determined that it
is appropriate to aggregate risks from the inhalation and dietary routes of -
exposure. For residents who live 300 feet from a treated field, the aggregated
lifetime, cancer risk estimates are 1 x 10'5; This estimate, however, is
associated with numerous uncertainties. Taking into account the
unquantifiable mitigation measures and more realistic assumptions on
exposure, EPA believes risks will be adequately mitigated under approved
labeling presented in the RED.
Environmental The Agency has adequate data to assess the toxiciry of 1,3-D to non-
Assessment target organisms and on 1,3-D's environmental fate. The registrant is also
t developing confirmatory data on the degradates, as well as data on estuarine
, and marine environments since 1,3-D use is expected to expand in Florida with
the methyl bromide phase-out. '
Environmental Fate
The data submitted for reregistration show that 1,3-D'is mobile and
persistent (particularly in colder areas). High quality data show that 1,3-D can
contaminate ground water under normal use conditions. EPA believes the
potential for ground water contamination is highest where soils are permeable
and water tables are shallow. Where these characteristics occur in colder
areas, 1,3-D not only enters ground water, but persists under colder conditions.
' , While EPA does not expect significant levels of 1,3-D in surface water, one
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study suggests that airborne levels of 1,3-D can be transported to adjacent
surface water resources. The registrant is conducting a run-off study and other
monitoring as confirmatory data.
Ecological Effects
1,3-D is highly toxic to invertebrate species, moderately toxic to birds
and mammals and moderately toxic to fish. These toxicity patterns are also
expected for estuarine and marine organisms; the registrant is generating
additional studies since 1,3-D use is expected to expand to estuarine and
marine environments.
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Ecological Effects Risk Assessment
* Assessment of submitted studies demonstrates that 1,3-D can
contaminate ground water under normal use conditions. EPA also reviewed
other sources of ground water sampling and found few detects, even in
counties where high rates of 1,3-D are applied every year. Thus, EPA believes
that 1,3-D use poses the potential for localized ground water contamination,
rather tJiaji widespread aquifer contamination. The registrant is amending 1,3-
D labels to prohibit use under the most vulnerable conditions (permeable soils,
shallow ground water, and cold temperatures).
The two degradates of toxicological concern, 3-chloroacrylic acid and 3-
chlorpallyl alcohol, were also detected in ground water studies. For the current
assessment, EPA assumed equivalent ecotoxicological parameters; the
registrant is conducting confirmatory data for the environmental fate and
ecbtoxicity of the degradates.
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Since 1992,1,3-D labels have been modified twice to include measures
Jo mitigate risks to workers and residents who live near treated fields. On
September 30, 1998, Dow AgroSciences again requested label modifications,
Which are scheduled to appear on all 1,3-D labels no later than August 1, 1999.
The measures added since 1992, together with the new modifications, are
summarized below: .
0 Measures to mitigate worker risks - Lowered maximum rates (lowered by
30% to 65% depending on the crop); Deletion of selected use sites; Closed
loading requirements; Technology to minimize 1,3-D spillage during
application? Improved product stewardship materials, Coveralls over short-
sleeved shirt and short pants; Chenucal-resistant gloves and footwear;
Chemical-resistant apron (for direct .handlers), A respirator requirement for all
1,3-D handlers (except those in certain closed cabs); Restricted entry increased
to 5 days; Soil moisture and soil sealing requirements; Modified application
techniques.
6 Measures to mitigate residential inhalation risks - 300' no-treatment buffer;
Lowered application rates (by 30% to 65% depending on the crop); Loading
''' ''''":" '' ' '" ' " ' ' '
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Additional Data
Required
Product Labeling
Changes Required
requirements; Technology to minimize 1,3-D spillage during application; Soil
moisture and soil sealing requirements; Modified application techniques.
Q Measures to mitigate residential drinking water risks - Ground water
advisory; Prohibition of use in certain northern tier states (N.D., S.D., WI,
MN, N.Y., ME, NJH., VT, MA, UT, MT) with shallow ground water and
vulnerable soils (effective 8/1/99); 100' buffer between drinking water wells
and treated fields (effective 8/1/99); Prohibition of use in areas overlying karst
geology (effective 8/1/99).
The following additional generic studies for 1,3-D are being conducted
for EPA to confirm its regulatory, assessments and conclusions. Because Dow
AgroSciences has already agreed to conduct .these studies, there is no generic
DGI associated with this RED. For 1.3-D. Dow AgroSciences is conducting
the* following studies: Freshwater fish early life stage; Freshwater aquatic
.invertebrate life cycle; Estuarine/marine fish LC 50; Estuarine/marine
invertebrate LC50; Estuarine/marine invertebrate LC50; Tier I and Tier n
aquatic plant; Seed germination and seedling emergence; Vegetative vigor; Tier
I and Tier II terrestrial plants; Aerobic aquatic metabolism. For the degradates
(3-chloroacrvlic acid and 3-rchloroallvl alcohol! Dow AgroSciences is
conducting the following studies:
Acute oral-rat; Acute dermal toxi city (rabbil/rat); Primary eye irritation
i (rabb'it); Primary dermal irritation; dermal sensitization;a battery of
mutagenicity data; developmental toxicology; subchronic 90-day feeding study;
aquatic aerobic metabolism; adsorption/desorption; hydrolysis; vapor pressure;
Henry's Law Constant; acute fish toxieity; acute aquatic invertebrate toxicity;
Tier I and Tier n aquatic plant studies.
Dow, AgroSciences is also conducting a tap water monitoring program
to assess whether levels of 1,3-D and/or its degradates of concern appear in
drinking water in areas with high 1,3-D use. The monitoring program is
designed so that risk reduction measures are initiated if 1,3-D and/or its
degradates are detected above the Office of Water's Health Advisory of 0.2 '
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
Perthe September 30, 1998 agreement with Dow AgroSciences, EPA
has contacted all end-use registrants of products, containing 1,3-D to inform
them of the required label changes, which are to take effect August 1, 1999.
The new labels are to contain the additional label measures as follows:
: Prohibitions in certain northern tier states (N.D., S.D., WI, MN, N.Y.,
ME, K.H, VT, MA, UT, MT) with vulnerable soils, prohibition of use in areas
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Regulatory The use of 1,3-D, in accordance with pending label changes, will not
Conclusion Pฐse unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
1,3-D products will be reregistered once the required confirmatory data,
required product-specific data, revised Confidential Statements of Formula,
and revised labeling are received and accepted by EPA. 1,3-D products which
also contain chlorppicrin will not be reregistered until the active ingredient
chloropicrin is determined to be eligible for reregistration.
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For More P?4- is requesting public comments on the Reregistration Eligibility.
^j^gjjฃ|Q j^ Decision (RED) document for 1,3-D during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
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obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources Branch,
Field:Op"erati'bns fusion" "(f5Q6C),office of Pesticide Programs (OPP), US
EJPA, WasWngton, D^
Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/REDs.
Printed copies of the RED and fact sheet can be obtained from EPAs
Cent^ and Information t ',,-.'
O'Box
(513)489-8196, fax (513)489-8695^ :
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Following the comment period, the 1,3-D RED document will also be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone (703) 605-6000 or (800)
553-6847. ' .' '" ..'" .'.. " ! , .' " [. ,
For more information about EPA's pesticide reregistration program, the
1,3-D RED, or reregistration of individual products containing 1,3-D please
contact the Special Review and Reregistration Division (7508W), OPP, US
EPA, Washington, DC 20460, telephone (703)308-8000.
For information about the health effects of pesticides, or for assistance in
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recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free
1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Time,
Monday through Friday.
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V
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
DEC 22-
CERTIFIED MAIL
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
Dear Registrant: ,
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case [0328] which includes
the active ingredient 1,3-Dichloropropene (or trade name Telone). The enclosed Reregistration
Eligibility Decision (RED), which was approved on September 30, 1998, contains the Agency's
evaluation of the data base of this chemical, its conclusions of the potential human health and
environmental risks of the current product uses, and its decisions and conditions under which these
uses and products will be eligible for reregistration. The RED includes the data and labeling
requirements for products for reregistration. It also includes requirements for additional data
(generic) on the active ingredient to confirm the risk assessments. .
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include 'further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the receipt of this
letter. The second set of required responses is due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of suspension
against your products. ; ,
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both the pesticide law (FIFRA) and the food and drag law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA implementation,
EPA recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete. In making these early case-by-case decisions, EPA does not
intend to set broad precedents for the application of FQPA. Rather, these early determinations
will be made on a case-by-case basis and will not bind EPA as it proceeds with further policy
development and.any rulemaking that may be required. .
Recycled/Recyclable
Printed with Sby/Canola Ink on paper that
contains at least 50% recycled fiber
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jf ,
If EPA determines., as a result of th|s later implementation process, that any of the
determinations described inthis RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this
RED. , ' '
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregistration Division representative Karen
Jones (703) 308-8047. Address any questions on required generic data to the Special Review
and Reregistration Division representative, Lisa Nisenspn (703) 308-8031.
Sincerely,
.in,1 HI,I : : I," i illln
'"'Enclosures
^ois A. KOSK, Director/
Special Review and
Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (IKED)
1 DATA CALL-IN (DCTl OR "90-DAY RESPONSE"-If generic data are required
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements/ If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms), the RED Fact Sheet, and the Acute Toxicity Batching Tables.
Registrants responsible for generic data are being sent response forms for both generic and
product specific data requirements (4 forms). You must submit the appropriate response
forms (following the instructions provided) within 90 days of the receipt of this RED/DCI
letter; otherwise, your product may be suspended. ',.."'
> , ' . ',,"-' - ' ,"
2- TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATIQN OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1).. Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e,below) to the address listed in item 5.
' '
, i ' -i '.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number 703-487-4650).
c- Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
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d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
ltern(ate igmulatipn.iE.. The labeHng and CSF which you submit for each product must
cqmply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
lYou 'hj^yejtwp options'for submitting a C1SF:" (1) accent the standard certified limits'(see 40 CFR,
ง158.175) or (2j provide certified limits that are supported by the analysis of five batches. If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR ง158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS TN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice whlcfi announces the availability of this RED.
5. tVHElRE TO SEND PRODUCT '"
PCI RESPONSES (90-DAY) AND
APPLICATIONS FORREREGISTRATION (8-MONTH RESPONSES!
Bv U.S.
jt)QCume|t Processing Desk (^b-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA,401MStS.W.
Wasnington, D.C. 20460-0001
Bv express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for complete:
complete will be returned with a recjuest for corrections. EPA will try
and time extension requests within 60 days. EPA will also try to respond to
submissions with a final reregistration determination within 14 months
issued.
ness; those which are not
to respond to data waiver
all 8-month
after the RED has been
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REREGISTRATION ELIGIBILITY DECISION
1,3-DICHLOROPROPENE (1,3-D)
. , '.;'. LISTA ; .;-' '' '
CASE0328
-------
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IV
INTRODUCTION
"n."
IWilti'".!'!!,,!1!:!' ,
" -"A. Chemical Overview ." .- 2
;_B. ^UseProjGIe....".''. .V.M.'.".'__.. .'.r.".'._.'.'.'".. /..._.. . / '. .'. ....... .2
'C. Ifctima^ .-!'.". ._.ji.'.',"!,. - -I ,.'..'. 4
~ata Requirements and Regulatory History '.. .' 5
D.
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SCIENCE ASSESSMENT '. 6
J fe""!!,1'!,,!'.],,,, 'I1'"illlHII: - ;i:t " I;}'!!! ' !ll t'W'VUtti* Illiilllll III i 'A- ', , ' ' ., , ..'! ''*
A, Physical and Chemical Properties Assessment 6
r^'-'vf: ':ซ,'i|. '"_ " Identification of Active Ingredient ' 6
'".'- ::!-:.' -|. ' 'Manwf|clurmg''and End-Use Product Chemistry ...'... 7
_ ' '' ' ;Jl Conclusions .:.:' :,- ; ,,,...-.,......,..,,... 8 ..
,B. _ i( T|Human Health Assessment . .,. i,i,.. .^.. . .;. , . . 8
'!" ,";'"';" ,1. i , Ha^ardAssessment ;i. .|V._ ;i.. .,..,..,.. , ; 8
ป ' ' ' "S11','ซ' : 'a. """" 'Acute Toxichy ' . . . 8
"i:", ".'",'. Mfci'/."-';i" b.' ' Subchronic Toxicity '.'.'.. ."".'. . .' '...''. .9
c. Chronic Toxicity/Carcinogenicity . . 11
d. Developmental Toxicity . -..'., 13
e. Reproductive Toxicity 13
f. Mutagenicity 14
,' :=:,",:""' g. Metabolism"'. . . .' .'.. . .".". . .' 15
h. Dermal Absorption 15
i. Epidemiological Data 15
2. Dose-Response Assessment 16
a. Determination of Susceptibility to Infants and Children .16
b. , .. AcjifeDigtiry %.' 17
c. Chronic Reference Dose (RfD) ....'.' 17
d. Classification of Carcinogenic Potential 18
e. Occupational and Residential Exposure 19
3. Dietary Exposure Assessment '....' 23
a. Dietary Exposure from Food Sources 23
b. Dietarj Exposure from Drinking Water 25
C. Occupational and Residential Exposure 34
1. Summary of'Use Pattern and Application Methods . 34
2. Exposure Mitigation Measures in "Effect"'...'.. 35
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a. Workers t. 35
b. Residents/Bystanders ..35
3. Factors Influencing 1,3-D Exposure . . . .. 36
. 4. f Exposure Monitoring Studies ....... 36
I a. Worker Monitoring Studies'..-.: 36
b. Resident/Bystander Monitoring Studies . . 37
5. Exposure Estimates Used for Risk Assessment ,,. '....'. . ; . .. .40
D. Risk Assessment _. .. . ........ 43
1. Dietary Risk and Characterization . 43
a. Food Source 43
b. Drinking Water Source ..................:,. ... . 43
c. Dietary Risk Characterization ... 48
d. Occupational and Residential/Bystander Inhalation Risk
Characterization . . ... ............ 49
e. Uncertainties in the Risk Assessment and Risk
Characterization Summary for 1,3-D .................; .54
E. Environmental Assessment .... 56
1. Environmental Fate arid. Transport . -.-. .......... ^.....:...... 56
'..ป' a. Environmental Fate Assessment of 1,2-D . 56
b. Degradation 56
c. Mobility 57
d. Field Dissipation .. .'.,...!..... 59
2. Water Resources . .. . ........ 59
a. Ground Water ..;..... 59
b. Modeling and Occurrence of 1,3-D in Surface Water ...... 64
c. Drinking Water Exposure Assessment . 65
3. Ecological Assessment 65
a. Toxiciry to Terrestrial Animals 65
b. Terrestrial Field Testing , ... . 67
c. Toxicity to Freshwater Aquatic Animals 67
d. Toxicity to Estuarine and Marine Animals .'.....'.....:.-.. 69
e. Toxicity to Aquatic and Terrestrial Plants . 70
f. Toxicity of Degradation Products and Manufacturing
Impurities ......... .'; 70
4. Exposure and Risk Characterization '.... ^ .71
a. Explanation of the Risk Quotient (RQ) and the Level of
Concern (LOG) .71
b. Field Data Used for Risk Assessment . .. ^. .............. 73
c. Exposure and Risk to Non-target Terrestrial Animals ..... 73
d. Exposure and Risk to Non-target Freshwater Aquatic
Animals . .._.... ... . . 76
e. Exposure and Risk to Estuarine and Marine Animals .... 78
f. Exposure and Risk to Non-target Plants .......... 79
g. Endangered Species .. 79
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION 79
A. Determination of Eligibility 79
";: ": : -""-"": 17" Eligibility Decision "'".'"."'".".'.'.'".'.'.'""..."..'.'..'.'. : . ..'..... 80
ซ;r'{:; -v'C. Regulatory Position 80
1. Summary of 1,3-D's Carcinogenicity . ... 80
ilf']'>,:;$v,$;;"* Jlfc^.^, Summary ofEPA's Approach to the 1,3-D Risk Assessment . . .. . . 81
K,\ .; ", ,;v.,,: '; . ;:i,,j.'i; k > a. Tolerances, Codex Harmonization and Dietary Risk . 81
Ill'l :"''i,/ij .'i1.;' V ' ' fi 11 '' i,'' i i '' 1-. >! ,.li||l!!l|il:'i! i tt'HI i1 fliifcitiliitTKIs'l !Mซ:iiซii>ii:i n'rwmSi.k is! KI: ill1, Jiiiin,!),:; IIIIIIIIIF L ,.- ., T ,,.
M:i' ' ''':;'Ill4|l;,:p! /iji' '^b^ ,iiir! .Aggregate and Cumulative Risk 82
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: c. Jฃf%cte'to'ihT^ '. .-.'. '. .V.'.' 82
2. Summary of 1,3-D's Benefits . . .."..... 83
3. Summary of Risk Management Decisions . .83
a. Bluman He^th ".T.".".J *.".". !T.".."."."..'.'' ". .',..".. ."83
b. Environmental/Ecological Effects ... 87
c. Restricted Use Classification ,:.,. . 89
d. Endangered Species Statement 89
e. Labeling Rationale 90
V. ACTIONS REQUIREi'o'F REGISTRANTS'' "!''!.".'.'. ?!. .".'.:". .". . .". !..'..'... 93
A. Amendments to Current 1,3-D Registrations 93
B. Requirements for 1,3-D Products 93
1. Additional Generic Data Requirements 93
a. Studies to be performed as a result of modified terms and
conditions of registration Studies on 3-chloroacryIic acid
and 3-chloroallyl alcohol 93
b. Studies to be performed as a result of modified terms and
Sir.;,' " .; S: ' conditions of registration - 1,3-D .. .^ ....'....'. 94
|;i:"|::';;v X;."; i1 c. Studies to be performed as a result of modified terms and
||l!'',; ',. , * .|: ' I1 Jl ' conditions of registration with tiered requirements - Run-off
;*'! ;' ;I :i'' " Study and 'studies' on" Ecbtoxicity""". .'.'.".". .'. .............. 95
d. Product Chemistry Requirements 95
2y- Formulation Changes . : 95
3. Time frames .'.... ; 95
4. Labeling Requirements for End-Use Products 95
, C. Existing Stocks '. 97
.Vi. /'APPENDICES"',/.,/".',/,.,.., ,,//.'/..,...,./.',.;/../,/./ .,.,,.:........99
A. Table of Use Patterns Subject to Reregistration 100
;;;:, 't',,, [" Jjjl. t ][?ble of the Generic Data Requirements and Studies Used to Make the
= ;:T: ,',",":_; Reregistration Decision' '. .".'.". .'. ."".. ". . .'.....' ". 101
" iiiili iป:'! i'1 s;f.; 'iC. Citations Considered to bei Part of the Data Base Supporting the
Reregistration Decision Ill
D. Product Specific Data Call-In 131
1. Chemical Status Sheets .'. 144
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2. Product Specific Data Call-in Response Forms (Insert A) Plus
Instructions 145
3. Product Specific Requirement Status and Registrant's Response
Forms (Insert B) and Instructions 147
4. EPA Batching of End-Use Products for Meeting Data Requirements
forReregistration '...'.. 154
5. List of All Registrants Sent This Data Call-in (insert) Notice .... 157
E. List of Available Related Documents and Electronically Available Forms 159
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REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
John Faulkner
Richard Michell
Margaret Cogdell
Economic Analysis Branch
Biological Analysis Branch
LUIS Representative
Environmental Fate and Effects Risk Assessment
KevinPoff *
Estella Waldman
Jim Carleton
James Felkel
JohnEisenman
Health Effects Risk Assessment
Nancy McCarroll x
Christina Scheltema
Catherine Eiden
Registration Support Risk Assessment
Jerri Stbwe
Risk Management
Lisa Msenson
FEAD
Susan Acree
Ecological Effects Branch
Fate and Monitoring Branch
Fate and Monitoring Branch
Ecological Hazard Branch
Environmental Risk Branch I
Toxicology Branch TJ
Risk Characterization and Analysis Branch
Risk Characterization and Analysis Branch
Fungicide-Herbicide Branch
Special Review Branch
Communications Branch
Office of General Counsel:
Andrea Medici
Office of General Counsel
Office of Stratospheric Ozone Protection:
Bill Thomas
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III 1Uliil'l'
I UI11F,
(111
GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
ADD
AADD
a.i.
::ARC
:::CAS
l:rcf
........ CSF
I ST.; 'is:
I
I'll I-:ii if IS tat
PFR
;;|>RES
I D'WEL
|l"f'liilillil1' II!'!:,:!',,',:!,! Bl'15 ',: ", Rill M1 ,, I!'1'11!!'!,! '
Acceptable Daily Intake. A now defunct term for reference
dose(RfD).
Average Daily Dose
Annual Average Daily Dose
Acid Equivalent
Active Ingredient
Anticipated Residue Contribution ""
, Chemical Abs|racts Service
Cation
Central Nervous System
Confidential Statement of Formula
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL
i:l ;:;,!;iiiBj)resentSi a ^(Sum specific (i.e. drinking water) lifetime
>:?;jf ..exposure at which adverse, non carcinogenic health effects
occur.
,-j i!i:iv:;;
< i 11;/::
'V ,11 I
m.
EP (orEUP)
"EPA
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SiStfU ;.'? "":"' i jซgpgc-^"
I ll'r UU'lllliinilllllllll11 H'lijJ' 'lil
OB
GLC
. GM
HA
"lADD
LC
1
I m::,m ..- iLpso
I 4 :s" "-If iiiii. iii'<
LDto
LEL
LOG
LOD
i u
'i'lT1'"
'^"'''itiariieidn'^'ecosystEra.'
End-Use Product
U.S.Enyborunental Prgtection Agency
Food and Agriculture Organization/World Health
Organization
Food and Drug Administration
Federal Jnsecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation, Battery t
Gas Liquid Chromatography
_,,_,,, Geqmetric..Mean i ..^
Generaliy Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal
guidance to municipalities and other organizations when
emergency spills or contamination situations occur;
Highest Dose Tested
Lifetime Average Daily Dose
Median L^ti^Concentratior^ A statistically derived
concentration of a substance that can be expected to cause
death in 50% of test animals. It is/usually expressed as the
weight of substance per weight or volume of water, air or
feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that
ซ;> ban'be'lexpected'to"11 cause' death in 50% of the test animals
;:,-,:,wheni|dtn^te^ _ -_
inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg!
Lethal Dose-low. Lowest Dose at which lethality occurs.
Lowest Effect Level .'..'.. '
Level of Concern
Limit of Detection
11
I i
ii
i ii in
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LOEL
MATC
MCLG
Mg/g
mg/L
MOE
MP '
MPI
MPJD
NAWQA
NTP
N/A
NOEC
NOEL
NOAEL
OP
OPP
Pa
PADI .
PAG
PAM
PD>
PHED
PHI
ppb
PPE .
ppm
PRN
QY
RBC
RED
REI
RfD
RS
RUP
SLN .
TC
TD
TEP
TGAI
TLC
TMRC -
torr
WPS
Lowest Observed Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) Tne MCLG is
used by the Agency to regulate contaminants in drinking
water under the Safe Drinking Water'Act
Micrograms Per Gram
Micrograms per liter
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of
recording and tracking studies submitted.
National Water Quality Assessment - USGS Water sampling
Program
National Toxicology Program ;
Not Applicable
, No Observable Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
Organophosphate .
Office of Pesticide Programs
pascal, the pressure exerted by a force of one newton acting
on an area of one square meter.
Provisional Acceptable Daily Intake '
Pesticide Assessment Guideline
Pesticide Analytical Method
Position Document related to a Special Review
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice '
The Carcinogenic Potential of a Compound, Quantified by the
EPA's Cancer'Risk Model . : ", ' '
RedBloodCell ,
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard '
Restricted Use Pesticide
Special Local Need (Section 24 ฉ of FIFRA)
Toxic Concentration. The concentration at which a substance
produces atoxic effect.
Toxic Dose. The dose at which a substance produces a toxic
effect . ; ' , ..' . .
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution
A unit of pressure needed to support a column of mercury 1
mm high under standard conditions.
Worker Protection Standard
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EXECUTIVE SUMMARY
Overview
The U.S. Environmental Protection Agency has completed its reregistration eligibility
decision for the pesticide 1,3-dichloropropene (1,3-D, or trade name Telone). This decision
includes a comprehensive reassessment of the required target data and the use patterns of
cuTOntiy registered products. 1,3-D is a soil fumigant used to control nematodes and certain soil
diseases. 1,3i-D is registered for use on soils to be planted with all food and feed crops. 1,3-D is
classified as a non-food use pesticide when used as a pre-plant soil fumigant and thus there are no
| intolerancesor exemptions from the requirement of a tolerance (for pineapples, 1,3-D is applied at-
;: j-^'V ,|;|'|;:. , |i|>lant, however there are no residues in food since fruit are not borne until the third year of
I' * i I'"1'"'"1"? 'I*- ':' i: fgrowtn}'. l,3-D""is a restricted use pesticide and as such can only be applied by certified
ficators" TEere are no homeowner uses of 1,3-D
1,3-D products are sold in bulk or mini-bulk (1000 gallon) containers and require no
mixing prior to loading. All 1,3-D product labels require closed loading systems for transfers
/iibetween^tijie bujk^nteiners and the specialized application rig, which is tractor-drawn. Most
IE 1,3-D use involves injecting the fumigant into soil at depths from 12-18" deep, followed by soil
sejjing such as compaction, a water seal or tarp. The soil seal is used to minimize the amount of
1,3-D which volatilizes into the atmosphere after application. There are also four state
'^eglstrations (known as SLN's) for 1,3-D application through drip irrigation, which is also applied
;;;'i i'iiiitii'11, ,.i'' iiiiiiiii ',:, filii'i'h liii,1"!: ', !i ,'" ':, ; i, '", ,114 fill I i if , ,; " ,' :l.' "' I,..:. ",.' liil .i,, iii ,' '. : fi! f , . u ly , t. ... -,'1'. i11,..1',,'.!..' ' D1', I " ' ,ป ', i1 , , , i ,',;
1,3-D was placed in EPA's Special Review process in 1986 based on cancer concerns for
workers. The potential for ground water contamination and residues in crops grown in treated
soils were also cited as concerns to be investigated. In 1991, the Special Review of 1,3-D
incorporated risks to residents who live in the vicinity of treated fields for inhalation exposures.
Since 1991, the registrant of 1,3-D, Dow AgroSciences, has modified 1,3-D registrations to
address; worker and residential c^nc^rns as, de^^led below,
Illl Ill III '.t . '' Ilii' i Sill'; il":1"1,":' '.:l',i';'" i' i': ป'if' V'l' J '''':);'i1' ซ (' i "i-f i:> s!)i \, '''*)" !'-' iiii'i 'i ' :i ' "'i>'i.' i"'1 j;,. " . '' -, .'. . v, " .
The Agency has concluded that 1,3-D, when labeled and used as specified in this
Reregistration Eligibility Decision (RED) document, will not cause unreasonable risks to human
health or the environment and that all labeled uses are eligible for reregistration. The Agency is
requiring data on two degradates, 3-chloroallyl alcohol and 3-chloroacrylic acid, to confirm the
Agency's assumption that the acid and alcohol are of equal or less toxiciry than 1,3-D.
Recent Label Modifications for Risk Mitigation
In 1992 and in 1996, Dow AgroSciences, requested label changes to reduce levels of
^TjS'-D^which yoj.a.tiHze into the atmosphere during fumigant transfers, application and the'post-
.ijEumigaiion. time period. Measures added to 1,3-D labels were shut-off valves to prevent 1,3-D
ฃJfrpjnoi spilling^atjrow turns, closed loading, soil sealing, a SOO-foot no-treatment bufrer from
>ied structores, improved product stewardship, a phase-out of drum delivery, and reduced
i r, '..ii i: pail '.i : "* i i- !,i'-'U aiiiii-' '..a1-.1 iv 'Tifin ,,;'is jyf 'wn:. (Mi1 J"IK. ."" . ".! .',. . > v '';. :.
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IV
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application rates. These measures reduced the largest sources of 1,3-D exposures, specifically,
the pooling of 1,3-D at row turns when the application "knives" were lifted out of the ground and
spills during loading. These measures reduced exposures not only for workers, but for anyone in
the vicinity of treated fields.
On September 30, 1998, Dow AgroSciences requested modification of the terms and
conditions of 1,3-D registrations to include use prohibition in certain northern tier states (ND,
SD, MN, NY, ME, NH, VT/MA, UT, MT, WI) based on ground water concerns, a 100-foot no-
treatment buffer around drinking water wells, prohibition of use in areas overlying karst geologies
and additional monitoring to confirm that use of 1,3 -D does not pose unreasonable risks when
used according to product labels. These measures reduce risks for anyone who drinks water from
wells in the vicinity of treated fields.
Risk Concerns - Human Health
1,3-D is classified as a B2 carcinogen by both the oral and inhalation routes of exposure.
The 1,3-D risk assessment presents aggregated risks for both routes of exposure. Because EPA
does not have toxicity data on the alcohol and,acid degradates, EPA assumed carcinogenic and
toxicological equivalence to the parent, thus oral exposure and risk estimates are comprised of
1,3-D plus the degradates (unless specifically noted).
Due to 1,3-D's careinogenicity, environmental fate and use patterns, EPA has concerns
that use could result in exposure to residues in air and/or water. EPA's cancer risk estimates for
workers who follow label restrictions are in the 10'5 to W6 range. For residents who live near
treated fields, lifetime cancer inhalation risk estimates are in the lO'5 to 10"8 range taking into
account a 300 foot no-treatment buffer, but not taking into account other measures (e.g.,
lowering application rates by 30-65%, soil sealing measures) which were not amenable to
quantification under the highly variable field study conditions.
For reregistration, EPA required a prospective ground water study in Wisconsin, which
was believed to be highly vulnerable to ground water contamination from 1,3-D use. The
registrant also submitted to the agency the results of a prospective ground water study conducted
in Florida. Based on the results of these studies and other sampling programs, EPA believes that
exposures from well water near treated fields vary depending on factors such as depth to ground
water, temperature, soil permeability, and distance from the treated field. Lifetime cancer risk
estimates from the Florida study are 4 x 10'6 (on-site wells which do not account for the 100 foot
buffer). In< Wisconsin, lifetime cancer risks for all age groups, and chronic non-cancer risks for
infants and children, were unacceptably high. Cancer risks associated with levels from on-site
wells were in the 10'3 range. As noted above, the September 30, 1998 modification includes a use
prohibition for northern tier states with characteristics similar to the Wisconsin site and will be
added to 1,3-D labels as of August 1, 1999.
Both prospective ground water monitoring studies included limited monitoring in off-site
wells located down gradient from the treated fields. In the Florida study, time weighted average
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'Cnit
'I'M
concentrations of 1,3-D plus its degradates in the on-site wells (10* deep) were 1.15 ppb.
centrations of 1345 plus degradates measured in wells located 100 feet down gradient
IT ..... , "< ''.!' I'lhiilliliil'l "",'i|. ........ 'I i ' ,|.li ' ! i,,i , " 1,1 ...... ,li',,,& ............. 1' ,,'.|| '"Tii: , in, i, ....... - ,,., ....... ...... ...... ..... ...... , , ........ , ,i, ..
-------
off, however, these models are not designed to track volatile soil fumigants. EPA is requiring
additional data on the degradates, on estuarine environments and a study to see if 1,3-D enters
surface water through runoff. >
Based on the results of retrospective ground water monitoring studies and the two
prospective studies, EPA believes that the conditions most likely to result in 1,3-D treatment-'
related ground water contamination are shallow water tables, cold temperatures and high soil
permeability, though the studies do not provide enough information to rank these factors. In
addition to the ground water monitoring studies, EPA reviewed the results of other sampling
programs in 1,3-D use areas and the U.S. Geological Survey's recent water resource monitoring
program results. The U.S.G.S. monitoring found no detections of 1,3-D, but did not look for
3-chloroallyl alcohol and 3-chloroacrylic acid.
Other Activities Related to 1,3-D's Reregistration
EPA will be reviewing new information on the carcinogenicity of 1,3-D, specifically,
whether EPA will regulate 1,3-D as a non-linear carcinogen. EPA expects this review will take
place sometime in 1999; however, no change in EPA's risk assessment, if needed, can take place
until the Agency implements final policies on regulation of non-linear carcinogens. EPA also
intends to issue a Position Document 2 (PD2) proposing to close out the Special Review for
1,3-D before the end of 1998. . ' ;
Before reregistering products containing 1,3-D, the Agency is requiring that product
specific data, revised Confidential Statements of Formula (CSF) and revised labeling be submitted
within eight months of the issuance of this document. These data include product chemistry for ,
each registration and acute toxiciry testing. After reviewing these data and any revised labels and
finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister, a
product. 1,3-D products which also contain chloropicrin will be eligible for reregistration only
when chloropicrin has been found to be eligible for reregistration.
vn
-------
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in i i mi
-------
I. INTRODUCTION
In 1988, the Federal Insecticide^ Fungicide, arid Rodenticide Act (TFTFRA) was amended/to
accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four phases
of the process focus on identification of data requirements to support the reregistration of an
active ingredient and the generation and submission of data to fulfill the requirements. The' fifth
phase is a review by the U.S. Environmental Protection Agency (referred to as "the Agency" or
"EPA") of all data submitted to support reregistration.
FIFRA Section 4 (g)(2)(A) states that in Phase 5 "the Administr.ator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base supporting a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from tiie currently registered uses of the pesticide, to determine the need for additional
data on health and environmental effects, and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA) 21 U.S.C. 301 et seq., and FIFRA 7 U.S.C: 136 et seq. The FQPA amendments went
into effect immediately. As a result, EPA is embarking on an intensive process, including
consultation with registrants, States, and other interested stakeholders, to make decisions on the
new policies and procedures that will be appropriate as a result of enactment of FQPA. This
process will include a more in-depth analysis of the new safely standard, and how it should be
applied to both food and non-food pesticide applications. FQPA did not, however, amend any of
the existing reregistration deadlines in section 4 of FIFRA. Therefore, the Agency will continue
its ongoing reregistration program while it continues to determine how best to implement FQPA.
This document presents the Agency's decision regarding me reregistration eligibility of the
registered uses of 1,3-D, including risk to infants and children for any potential dietary, drinking
water, dermal, or oral exposures, and cumulative effects as stipulated under FQPA. The ,
document consists of six sections. Section I is the introduction. Section n describes 1,3-D, its
uses, data requirements and regulatory history. Section IE discusses the human health and '
environmental assessment based on the data available to the Agency, Section TV presents the
reregistration decision for 1,3-D. Section V discusses the reregistration requirements for 1,3-D.
Finally, Section VI contains the Appendices which support this Reregistration Eligibility De'cision.
-------
CASE OVERVIEW
I ..... ii
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Commercial 1,3-dichloropropene is a mixture of approximately equal proportions of the
111 ||ffl 1 .wit!1'!,11' ." ป ii!,l,''4i!i!, ,in1',!!!! 'i:!!1',!","1! ItnlHi "tl!,": 'i : : ,ii ",,1111 i ,:" '.m. * * ** f., . * . , * , * , . , ,..,
$?fr,Si!Sis,rtaSSSt 33H* Telone E formulation contains 94% 1,3-dichloropropene and 6%
jKnert ingredients. The Telone C-17 formulation, which is formulated with 16.5% chloropicrin,
contains 77.9% 1,3-dichloropropene and 5.6% inert ingredients. A contaminant, 1,2-
dichloropropane may also be present in small quantities (<,(
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility Decision:
Common Name:
Chemical Name:
Trade and Other Names:
Chemical Family:
:t , ,''.!' ii 'l| "i I!'1!1::,1'!!! ' PI,. ' i ,. i,,,
CAS Registry Number:
Opjp Chemical Code:
Empirical Formula:
Basic Manufacturer:
1,3-Dichloropropene
1,3 -Dichloropropene
1,3-D, Teloneฎ, Trilone, Pic-Clor, Tri-Form
Chlorinated Hydrocarbon
'' i
542-75-6 " ^ "" . ^ '/"
029001
'C3H4C12'"' " " ";'' ''
Dow; AgroSciences
Multiple active ingredient products contain: 081501 (chloropicrin)
Registered "Me Too" Products Not Included in Appendix A: 8536-8; 8536-21; 8536-22;
n22Q-l; li22()-l5; 11220-20; 11226-21; 11220-22
",; iiii
B.
Use Profile
The following is general information on the current registered uses with an overview of
use sites and application methods. A detailed table of these uses of 1,3-D is in Appendix A.
Although the Appendix A information only reflects the basic manufacturer's products (i.e.
DowAgro Sciences' Telone n and Telone C-17), the 1,3-D uses and use rates for the "me too"
products are the same as those of the basic manufacturer's single and multiple active ingredient
products, respectively.
2
-------
TYPE OF PESTICIDE FOR SINGLE ACTIVE INGREDIENT:
Nematicide; Fungicide; Insecticide; Herbicide
MODE OF ACTION:
Soil fumigant^ contact poison ,
.USE SITES: . ' : '"._'
1,3-D is registered for use on all crops to be planted on 1,3-D-treated soils. Thus,
the use sites include all vegetable, fruit and nut crops, all forage crops (grasses,
legumes and other non-grass forage crops), tobacco, all fiber crops and all nursery
crops (ornamental, non-bearing fruit/nut trees and forestry crops).
. i
1,3-D is classified as a non-food use pesticide (and thus there are no tolerances or
exemptions from the requirement of a tolerance).
TARGET PESTS FOR SINGLE ACTIVE INGREDIENT:
Plant-Parasitic Nematodes: all types
Plant Diseases: bacterial canker of peaches, sugar beet rhizomania, fusarium wilt
of cotton, verticillium wilt of mint
Invertebrates: symphylans (garden centipedes), wireworms
Weeds: Canada thistle, field bindweed (perennial morning glory), quackgrass, and
certain other deep-rooted perennial weeds in cropland
TYPES/FORMULATIONS REGISTERED:
End Use Products - ,
Liquid-Ready to Use - 78.3 to 94.0% (78.3%, and 94.0% multiple and
single active ingredient products, respectively)
Note: single and multiple active ingredient "me too" products containing
37.6 to 94.0%, 1,3-dichloropropene are also currently registered.
METHODS AND RATES OF APPLICATION:
Types of Treatment: Soil fumigation, broadcast and/or row treatments, and
individual tree planting site treatments ;
-------
r
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"I'll!' fe
Equipment: Soil injection equipment (chisel, Nobel plow, or plow-sole); Deep
drip irrigation (6 or more inches deep)
Timing: Preplan! (all crops); at planting (pineapple)
Application Rates: See rates listed in Appendix A for the Dow AgroSciences
products (62719-12, 62719-32), which reflect the maximum rates of 1,3-D in
gin|le and multiple ingredient (i.e.,, with chloropicrin) formulations, respectively.
Maximum rates for uses on vegetable and field crops varies with the soil type.
nillliil ,n!'|" !':i ,, ,'"!i ,!., "'I, ',!"i,'i:4i'|!!', ,' .I'lUI ,1|IN ii'l,1', J '- 'I1!'..;'1 .i'l,',,"' iMKIO1!'1!!,,, i5T,,,,f , ป ,, !,,.,, ,, , . ,r^ , , , ,, J r , , ,
[^aximurn rates for a given crop are typically slightly higher for the multiple active
Ingredient product than the single active ingredient product.
USE PRACTICE LrMITATTONS (APPLIES TO ALL 1,3-D PRODUCTS):
1.,3-p is a restricted use pesticide (certified handlers only). Label statements
include,a 300 foot no-treatment buffer zone between treated fields and occupied
structures, a five-day restricted entry interval for workers, closed loading, soil
|ga|jqag immediately following application. In addition, labels suggest waiting at
least one week for every gallon of 1,3-b applied before planting due to
phytotoxicity.
See section IV. C. (3) for a list of detailed restrictions.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticidal uses of 1,3-D.
These estimates are derived from a variety of published and proprietary sources available to the
""', The estimates presented in Table 1 are primarily from a 1991 Data Call-In for use and
All 1,3-D is used on agricultural crops; there are no residential uses. The following table
estimates 1,3-D use by site:
V ' i 'It''.
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-------
Table I. Major 1,3-D Usage Sites
Crop
Cracifers
Peppers
Cucurbits
Sugar Beets
Cotton
Tobacco
Irish Potato
Sweet Potato
Peanut
Fruit/Nut
Trees and
Grape Vines
Onions
Tomato
Carrots
Pineapple
Strawberries
Acres Treated (000)
weighted
average
10
-5
13
45 ,
85
80
80 .
N/A
12
27 .
5 '
2
2 ' ' . '
5
1
estimated
maximum
22
10
27
'55 '
150
102
95
N/A'
25
54
10
5
4
7
4
% Crop Treated
weighted
average
4
4
2. '.
3
1
11 -
6
N/A
1 .
6 -
5
o
2
14
1
estimated
maximum
8 ;
8
4
4 -
1
15
7
N/A '
2 .
13
10
1
4
19 :
3 -
Ibs a.i. applied (000)
weighted
average
2000
400
600
4000
2000
7200 ,
1350
N/A
700
2400
1000
200
150
1300
80
estimated
maximum
3500
800
1200
5500
6000
9000
1700
N/A
1900
5000
2000
800
250 ,
2600
170
States where
most usage
occurs
AZ,TX,GA,
SC,NCCA
NMiNC,CA
TXAZ,SC,
NC,GA,CA
NE,WY,CCy
ID .
AZ,NC,GA,
FL,CA
NC,SC,GA
WA,ID,OR,
COJNDJVQ
NC, GA, SC
AL,GA,TX
CA,SC,NC,
AZ,GA,NJ
OR,WAJD
GAJFL,AL
CAWA,TX
HI
Usage data covers 1990-1995 formostsites and as early as 1987 for other sites, primarily using data from the 1991 Use Usage and Product
Performance DCI: California data is only available for 1994 and 1995 due to the 1991-1993 use permit suspension and limited re-entry program
Weighted average" weights the more recent years' estimates because they tend to be more reliable estimates than for possibly outdated earlier
estimates. , . /
D. Data Requirements arid Regulatory History
1,3-D was first re^stered in 1954 in the United States. A Registration Standard was
issued in 1986, along with a Position Document announcing initiation of a Special Review (51 FR
36160) based on cancer concerns for workers. The Standard evaluated the available data with
-------
other relevant information on 1,3-D and required the submission of additional data to maintain the
existing registrations and to further refine the risk.assessment for the Special Review.
On April 13, 1990, California suspended use permits for 1,3-D because unacceptably high
levels of airborne 1,3-D were detected through its air monitoring program. After California
suspended the 1,3-D use permits, EPA looked more closely at the risk posed to residents who live
in the vicinity of treated fields. In 1992? Dow AgrpSciences (at that time DowElanco), agreed to
iabel measures to reduce the amount of 1,3-D that volatilizes into the atmosphere, including
closed loading^shut-off valves to prevent 1,3-D from spilling at row turns, improved product
stewardship, a phase-out of drum delivery, and reduced application rates. DowElanco also agreed
to conduct studies to determine the mitigation value of these and other measures.
In 1996., other measureSj including the Worker Protection Standard requirements for
Personal Protective Equipment (PPE), were added to 1,3-D labels, including soil sealing, a 300-
foot no-treatment buffer from occupied structures and other requirements designed to minimize
the amount of 1,3-D mat volatilizes (Gibson, 1995) These measures reduced exposures for both
I1 'I'll r , IP'1 .i,,'1 i ""!' ,',, Ill'", ,, Ill" ,1 i!l'"l,ฅ* ' II ii 11 ' ซ ." - i . , i. i. *,
workers and anyone else who lives or works in the vicinity of treated fields. "
. i ' ''
On September 30, 1998, Dow AgroSciences requested modification of the terms and
conditions of 1,3-D registrations to include use prohibition in certain northern tier states (ND,
SD, MN, NY, ME, NH, VT, MA, UT, MT, WI), a 100-foot no-treatment buffer to drinking
water wells, prohibition of use in areas overlying karst geologies and additional monitoring to
confirm that use of 1,3-D does not pose unreasonable risks when used according to product labels
* (Roby, 1998). The benefits of these measures are to reduce risks for anyone who drinks water
from wells in the vicinity of treated fields, particularly wells in unconfined aquifers.
Dow AgroSciences is developing confirmatory data for reregistration, to include tap water
monitoring in certain 1,3-D use areas, a run-off study and data on the toxicity and environmental
fate data for 3-chloroacrylic acid and chloroallyl alcohol.
This Reregistration Eligibility Decision reflects an assessment of the data which were
submitted in, response to the 1986 Registration Standard and the 1991, 1992 and 1996 DCI's.
III ' ' 'i ' (ill I i i i I " i i i I I ' _ -'i ':;' , { ' ' ',. :"
m. SCIENCE ASSESSMENT
A. Physical and Chemical Properties Assessment
1. Identification of Active Ingredient
iii, ii i in ,j , , ',,..'ป ; ' "i1 - , . ,,
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The actiye ingredient 1,3-dichloropropene (1,3-D, or Telqne) is a soil fumigant used
preplant to control root-knot nematodes and other soil pests and diseases. 1,3-D is a mixture of
isomers; in the figures below, the trans isomer is on the left, and cis on the right.
-------
Empirical Formula: - C3H4C12
Molecular Weight: 110.98
Physical State: liquid under pressure, volatile
Odor:
Water Solubility:
Vapor Pressure:
Boiling Point:
sweet, pungent, penetrating
2,180 mg/L for cis isomer
2,320 mg/L for trans isomer
34,3 mmHg for cis isomer at 25ฐC
23.0 mmHg for trans isomer at 25ฐG
104ฐC for cis isomer
112.6ฐC for trans isomer
Specific Gravity: 1.209g/mLat25ฐC
2, Manufacturing and End-Use Product Chemistry
A search of EPA's Reference Files System conducted on September 9, 1998 identified no
1,3-D manufacturing-use products (MPs) under Shaughnessy No. 029001. Although the 1985
1,3-D Reregistration Standard dated identified a single 94% formulation intermediate registered
to Dow Chemical Company (EPA Reg. No. 464-511), the product has since been transferred to
Dow AgroSciences (EPA Reg. No, 62719-32) and is currently registered as an end-use product
(EP). The product jackets for 1,3-D EPs confirms that'the Dow AgroSciences 94% EP/MP is
the source product for other formulations; therefore, generic (TGAI) and product-specific (MP)
data are required to support its use as an MP. Dow AgroSciences has submitted an application'to
also market their 94% 1,3-D product as a manufacturing use product to reformulators; this
application is under review. .
-------
3.
Conclusions
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All pertinent generic data requirements are satisfied for the 1,3-D TGAI except for the
new data requirement concerning UV/yisible absorption (OPPTS GLN 830.7050). All product-
specific data requirements are satisfied for the 94% EP/MP; however, the ingredient certifications
(OPPTS GLN '830.1750)'must'Be submitted on EPA IForm 8576-4. The data requirements for
product chemistry are presented in Appendix D. In addition, the registrant must certify that the
suppliers of beginning materials and the manufacturing processes have not changed since the last
comprehensive product chemistry review or submit a complete updated product chemistry data
S'package.
B.
Human Health Assessment
1.
Hazard Assessment
All toxicology guideline studies are fulfilled and the data base for 1,3-D is adequate to
support reregistration eligibility. Across the battery of toxicology studies, the Telone test
products contained various amounts of 1,3-D depending on the formulation available at the time
of testing. Because of this, the toxicity tests were performed with varying percentages of the a.i.
EPA does not believe the variations in levels warrants additional testing.
IH i |II|| :'" ':!,';( .. ,;:;;!'; ' f'4 .,'''''5 iii i.-W'l'1'1' :' ,r > ,'.> :' -,"> ป i ' . . V '
"J/'a. ","Ac.nte.Toxicity
The acute toxicity values and categories for 1,3-Dare summarized below:
Table 2. Acute Toxicity of 1,3-Dichloropropene
OPP
Guideline
No.
81-1
81-2
81-3
81-4
81-5
81-6
81-8
OPPTS
Guideline
No.
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6200
Study Type
Acute Oral
Acute Dermal - Rabbit
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
Acute Neurotoxicity
MRID #(S).
40220901
40220902
40220903
40220904
40220905
40220906
none
Results
LD50 = 300 mg/kg (M)
224 mg/kg (F)
LD50 = 333 mg/kg
LC50 = 3.88 mg/L (M)
4.1 mg/L(F)
Intermediate irritant
Slight irritant
Sensitizer
None required
Toxicity
Category
II
n
IV
n .
in
..
-------
The oral LD50 in the rat was 300 mg/kg in males and 224 mg/kg in females (Toxicity
Category IT). Clinical signs included diarrhea, lacrimation, chromodacryorrhea, palpebral closure,
facial/perineal soiling, labored respiration and rough hair coat Gross necropsy revealed gastric
hemorrhage, watery contents and mucus in the cecum, thickened stomach wall and adhesions
between the stomach and abdominal wall (MRID 40220901).
The dermal LD50 in the rabbit was 333 mg/kg. Animals exhibited restlessness, squealing,
lethargy, transient anorexia, labored respiration and diarrhea. Skin findings were erythema,
edema, necrosis and scabs. Gross necropsy revealed mottled skeletal muscles in hind limbs,
multifocal erosions and/or ulcers of the stomach and fecal soiling-of the perinea! area (MRID
40220902).
The inhalation LC50 in the rat was 3.88-4.69 mg/L in males and 4.1 mg/L in females
(Toxicity Category IV). Animals exhibited tremors, convulsions, salivation, lacrimation, diarrhea
and lethargy. Gross necropsy revealed hemorrhaging in multiple lung lobes (MRBD 40220903).
Instillation of Telone II (94% a.i.) in rabbit eyes resulted in intermediate irritation
(Toxicity Category H). By day 14, all evidence of corneal opacity, iris irritation, conjunctival
redness, chemosis and discharge had disappeared (MRID 40220904). , .
In a rabbit dermal irritation study, very slight erythema and edema were noted (Toxicity
Category ID). At 72 hours, 5 of 6 animals had well-defined erythema, 1 of 6 exhibited very slight
erythema, 2 of 6 exhibited slight edema and 2 of 6 had very slight edema (MRID 40220905).
Telone II (94% a.i.) was a sensitizer in guinea pigs (MRID 40220906). ' .;
b. Subchronic Toxicity
(i)
Oral
Telone n (96.0% a.i.) was administered to Fischer 344 rats (10/sex/group) at dietary
levels of 0, 5, 15, 50 or 100 mg/kg/day for 13 weeks. Body weights and weight gains, as well as
food consumption, were reduced at 50 arid 100 mg/kg/day in both sexes (questionable reduction
in male body weights/gains at 5 and 15 mg/kg/day). Doses of 15, 50 and 100 mg/kg/day caused
hyperkeratosis and/or basal cell hyperplasia in the nonglandular portion of the stomach of both
sexes. The NOEL was 5 mg/kg/day. The LOEL was 15 mg/kg/day based upon hyperkeratosis
and/or basal cell hyperplasia in the nonglandular portion of the stomach of both sexes (MRID
42954802). -
In a subchronic study, Telone n (96.0% a.i.) was administered to B^F! mice
(10/sex/group) at dietary levels of 0, 15,50, 100 or 175 mg/kg/day for 13 weeks. Body weights
and weight gains were lower than the controls in males and females at 50, 100 and 175 mg/kg/day
(27, 36, 39 and 58% in males and 7, 22, 30 and 32% in females). The NOEL was 15 mg/kg/day.
-------
The LOEL was 50 mg/kg/day based on lower body weights and body weight gains compared with
controls;in males and females (MRID 42954801).
The data requirement for a subchronic dog study was waived because a one-year study
.;;, ;;:[ ; Jhadbeen conducted, . , , ; :ii '
I | III I III ' ', , " , !" i' Vi"ป\ ' T ' ป ' ' l' ' j ' " "' ' " '
(11) Inhalation
In a 30 day inhalation study, Fischer 344 rats (10/sex/group), were exposed to Telone II
("production grade" - no percentage of a.i. presented) at concentrations of 0, 3, 10 or 30 ppm (0,
0.0136, 0.045 or 0.136 mg/L), 6 hours/day, 5 days/week for 4 weeks. There was no mortality at
any dose level. Body weights of male ratsi at all concentrations were similar to that of the
controls, Females e^|>i1:ง 30 ppm (0.136
:ini/L) (MRID 00039685).
fi; irkr1 I|M' liiiM "! i IIP in i V i ,'' .' '':' .'
In a 30 day inhalation study, CD-I mice (10/sex/group), were exposed to Telone II
("production grade"- no percentage of a.i. presented) at concentrations of 0, 3, 10 or 30 ppm (0,
jj).0l3^ 0.045 or 6.136 mg/L), 6 hours/day, 5 days/week for 4 weeks. There was no mortality at
any dose level. There were no test article related findings at any dose. The NOEL was 30 ppm
1 (0.136 ing/L, highest dose tested) and the LOEL was > 30 ppm (0.136 mg/L) (MRTD 00039685).
In a subchronic toxicity study, Fischer 344 rats (10/sex/group) were exposed to Telone n
^Q.9Yo,^.)^t^n^nMom of 0, 10, 307_ .90 or 150 ppm (0, 0.045, 0.136, 0.408 or 0.680
:i Mir;|i|!;; :i -:"it|/L), 6 hours/day, 5 days/week for 13 weeks. Both sexes at 90 and 150 ppm exhibited a
I!l" lllll!j|' /'':"' ill^^l^ec're^e ^ bociy '^eights while rate, at'30," 90 and 150 showed treatment-related
>'''"jl;.ซ t| ' .,: JiBstopafnologicai' lesions'in the" nasal torbinates.'' The NOEL was 10 ppm '(0.045 mg/L) and the
LOEL was 30 ppm (0.136 mg/L) (MRID 00146461).
S ivjji , ' iilSpi '! I ~ll t^ I " .'...".' 'ii ;' ' ' l;',f I '' |i ; ' Ui ' , 'i
ljW.hlf '' Eli i I'III i ' 'K -fif,:" ;i;-" :'?:''' ".")' '; :i:'"'' ' :- ',, ! '..' .:':,!
In a subchronic toxichy study, "BtCzFi mice (10/sex/group) were exposed to Telone n
I |90.9% ai) at concentrations of 0,10, 30, 90 or 150 ppm (0, 0045, 0.136, 0.408 or 0.680 mg/L),
6 hours/day, 5 days/week for 13 weeks. Both sexes at 90 and 150 ppm exhibited a significant
decrease in body weights while females showed epithelial degeneration and hyperplasia of the
nasal turbjnates. The NOEL was 30 ppm (0.045 mg/L) and the LOEL was 90 ppm (0.136 mg/L)
(MRID 00146461).
'" 1", i'lini ' \ , ; . . i , . ' . ... " >..,! '.'! ; ". ' , :...: '':; . . I1,!1-!';:1: , . I . ' ' ' ',
10
-------
c. Chronic Toxicity/Carciraogenicity
(i) Oral
In a chronic toxicity/carcinbgenicity study, Telone n (96% a.i.) was administered as
microcapsules by dietary admix to Fischer 344 rats (60/sex/group with 10/sex/group sacrificed at
12 months) at levels of 0, 2.5, 12,5 or 25 mg/kg/day for two years. Body weight gains were
decreased for males (8 and 21%) and females (15 and 25%) at 12.5 and 25 mg/kg/day compared
to controls. Food consumption was decreased in females at 25 mg/kg/day. There was an increase
in liver masses/nodules in males only at 12.5 and 25 mg/kg/day. There was an increased incidence
of basal cell hyperplasia of the nonglandular mucosa of the stomach of both sexes at the 12- and
24-month sacrifices at 12.5 and 25 mg/kg/day. For chronic toxicity, the NOEL was 2.5
mg/kg/day and the LOEL was 12.5 mg/kg/day based on a decrease in body weight gain
compared with controls and an increase in the incidence of basal cell hyperplasia of the
nonglandular mucosa of the stomach. There was evidence of carcinogenicity: The incidences of
rats with primary hepatocellular adenomas were as follows respectively (0, 2.5, 12.5 or 25
mg/kg/day): males = 2/5.0, 1/50, 6/50 and 9/50; females - 0/50, 0/50, 0/50 and4/50. These data
indicate that exposure to 1,3-D increases the incidence of these tumors in males at the two highest
doses and in females at the highest dose. The highest dose tested in this study (25 mg/kg/day)
was considered adequate to assess the carcinogenic potential of 1,3-D in. rats (MKDD 43763501).
The results of this study were used to establish. the oral reference dose (RfD).
In a study reported by the National Toxicology Program (NTP) in 1985, 1,3-D (89.0%
a.i.) was administered in corn oil (with 1.0% epichlorohydrin) by gavage to Fischer 344 rats
(52/sex/group) at doses of 0, 25 or 50 mg/kg/day three times per week for 104 weeks. Basal cell
or epithelial hyperplasia of the forestomach was reported. At 0, 25 and 50 mg/kg/day, squamous
cell papillomas of the forestomach (1/52, 1/52 and 9/52 in males respectively; 0/52, 2/52 and 3/52
in females respectively), squamous cell carcinomas of the forestomach (0/52, 0/52 and 4/52 for
males) and neqplastic nodules of the liver (1/52, 6/52 and 7/52 for males respectively ; 6/52, 6/52
and .1 0/52 for females respectively) were seen. The NTP concluded that there was "clear
evidence of carcinogenicity" for males and "some evidence" of carcinogenicity for females (MRID
00146469). .
In a two-year toxicity/carcinogenicity study in B^Fj mice (50/sex/group), Telone n
(95.8% a.i.) was administered as microcapsules by dietary admix at levels of 0, 2.5, 25 or 50
mg/kg/day. There were no test article effects on clinical signs, mortality, ophthalmology,
hematology parameters, organ weights, macroscopic pathology or microscopic pathology. For
chronic toxicity, the NOEL was 2.5 mg/kg/day. The LOEL was 25 mg/kg/day for both sexes
based on lower body weights and a decrease in weight gains compared with controls. There was
no evidence of carcinogenicity (MRID 43757901).
In a study with E6C3F1 mice (50/sex/group) reported by NTP in 1985, Telone H (89.0%
ai) was administered in com oil (with 1,0% epichlorohydrin) by gavage at doses of 0, 25 or 50
mg/kg/day three times per week for 1 04 weeks. The study in males was not considered to be
' > . . ' . n ';... .:'.'
-------
"ซ I 'HIM,' I1!'11! !ii''i!!liiill!l"
I nil
gdeguate because of the mortality of controls at weeks 48-51 (25/50, myocarditis) and the 104-
week survival for males (8/50, '28/50 and 31/50). Squamous cell papillomas of the forestomach
_^ ^ _ _ ,.^_.. for fences), squamous cell carcinomas of the forestomach (0/50, 0/50 and
2/50 for females), transitional cell carcinomas of the urinary bladder (0/50, 8/50 and 21/48 for
controls). For females, there was "clear evidence of carcinogenicity" (MRID 00146469).
^ina. chronic toxicirystudy, beagle dogs (4/sex/group) were administered Telone n (95.8%
ai.) as a dietary admix at levels of 6, 6.5, 2.5 of 15 mg/kg/day for one year. At 15 mg/kg/day,
there was; decreased body weight gain; hypochromic, microcytic anemia (increase in erythrocytes
along with decreases in hemoglobin, hemafbcrit, mean corpuscular volume and mean corpuscular
hemoglobin); hematopoietic activity in bone marrow and spleen; and a possible increase in
Absolute liver weights inmales- For ,.. Si i,*ซ ซ . . ; -,- , ,
decrease in body weight gain in 60 ppm males (3-9%) and females (2-11%). urinary bladder
12
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-------
effects were noted primarily in females at 20 and 60 ppm (slight, moderate or marked roughened,
irregular and opaque surfaces were reported in 20/50 at 20 ppm and 30/49 at 60 ppm compared '"
with 3/50 slight in the control group). Hypertrophy and hyperplasia of the nasal respiratory
mucosa (very slight/slight) were observed in most 60 ppm mice of both sexes and in 20 ppm
females. Degeneration of olfactory epithelium (very slight/slight) was noted in most 60 ppm mice
of both sexes. Hyperplasia of the epithelial lining of the nonglandular portion of the stomach was
observed in 60 ppm males (0, 5,20 and 60 ppm: males = 0, 3, 1 and 8; females = 0, 0, 0 and 2
respectively). For chronic toxicity, the,NOEL was 5 ppm (0.023 mg/L) and the LOEL was 20
ppm (0.091 mg/L) based oh urinary bladder hyperplasia and hypertrophy/hyperplasia of the nasal
respiratory mucosa. Hyperplasia of the epitheliaiaining of the nonglandular portion of the
stomach was observed in a higher incidence compared with controls in 60 ppm males and, to a
lesser extent, 60 ppm females. There was evidence of carcinogenicity. Bronchioloalveolar
adenomas appeared in a higher incidence in 60 ppm males only compared with controls (0, 5,20
and 60 ppm = 9/50, 6/50, 13/50 and 22/50 respectively). Although the lung tumors noted in this
mouse inhalation study were benign, the tumor induction was dose dependent, the tumor
incidence was outside the range of historical controls and the tumor type was also seen in the
mouse oral bioassay (MKED 403123 00). .
^ ' ' = " . ' '
d. Developmental Toxicity
In a developmental toxicity study, Fischer .344 rats (3 0 females/group) were exposed
during gestation days 6 through 15 to aerosol concentrations of Telone H (90.1% a.i.) at 0, 20, 60
or 120 ppm (equivalent to approximately 0, 0.091, 0.272 or 0.545 mg/L) 6 hours/day. The
maternal NOEL was < 20 ppm (< 0.091 mg/L). The maternal LOEL was 20 ppm (0.091 mg/L)
based on decreased body weight gains and food consumption compared with controls during the
exposure days. The developmental NOEL was,60 ppm (0.272 mg/L). The developmental LOEL
was 120 ppm (0.545 mg/L) based on increase in delayed ossifrcation of the vertebral centra. No
1,3-D-related malformations were reported (MRID 00152848).
New Zealand rabbits (17-24 females/group) were exposed to aerosol concentrations of
Telone H (90.1% a.i.) at 0, 20, 60 or 120 ppm (equivalent to approximately 0, 0.091, 0.272 or
0.545 mg/L), 6 hours/day during gestation days 6 through IS. The maternal NOEL was 20 ppm
(0.091 mg/L). The maternal LOEL was 60 ppm (0.272 mg/L) based on decreased body weight
gains compared with controls. The developmental NOEL was 120 ppm (0.545 mg/L). The
developmental LOEL was >120 ppm (> 0.545 mg/L, HDT). No 1,3-D related malformations
were reported (MRlD 00152848).
'.'-,.'' - ' - '
e. Reproductive Toxicity
In a two-generation inhalation reproduction study, Fischer 344 rats (F0 adults, 30 males
and 40 females/group) were exposed to aerosol concentrations of Telone H (91.2% a.i.) at 0, 10,
30 or 90 ppm (equivalent to approximately 0, 0.045, 0.136 or 0.408 mg/L) 6 hours/day. The
durations of exposure (6 hours/day) were as follows: F0 males and females 5 days/week prior to
breeding and 7 days/week during breeding at weeks 11 to 13, then during gestation and lactation;
' , - :.-..' 13 ':' ';'". ....'-: '.'
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i-f'C ..... ft ..... VS. ..... ff ....... KfflR*J ........ fi-f' IK '"ซ -!i ' ': ..... HE:' aSttUR XX. ..... I T ? iTWi ...... liTil'i' i! ..... iS. "IV 1851 '.-'"' lit' '
,11 [ ,,. :.i", ". BUM
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iFj, and Fib generations, dams from gestation day 20 until postpartum day 5; Ft male and female
parents, after weaning (about week 32 of the study) and continued for 12 weeks, but for 5 days
per wlelc, 6 hours/day; and F0 to Fx until adults were sacrificed. Pregnant females were not
exposed to 1,3-D from gestation day 20 to postpartum day 4. Pups were not exposed to 1,3-D
(dams separated from pups for 6 hours of exposure/day during lactation days 5 to 28). For
parental/systemic toxicity, the NOEL was 30 ppm (0.136 mg/L).' The LOEL was 90 ppm (6.408
mg/L) based on a decrease in body weight gain compared with controls, as well as microscopic
nonglanduiar stomach lesions (mainly mucosa) and hyperplasia of the nasal respiratory epithelium
with focal degeneration of the olfactory tissue. No reproductive toxicity was seen. For
reproductive toxicity, the NOEL was 90 ppitn and the LOEL was >90 ppm (HOT) (MRID's
40312401 and 40835301).
ill' ' I III H i, ''' .,..''!' .''.' ''7
f. Mutagenicity
I" ' '
_ There was a positive effect in the Salmonella assay in strains G46, TA98, TA100 and
IJA153J5.,\vitibi and without activation and in strains TA1538 and TA1537 with activation.
||e,spbnses up to approximately lOOx and lOx background in strains TA1535 and TA100,
Respectively, were seen (MRJDD 56639688)- 1,3-D, in the absence of metabolic activation, was
positive in the B. subtilis rec-assay only at 1,250 Mg/well (MRID 00039688). Up to a toxic
concentration of 1,666 ug/plate, no positive results were reported in the E. coli reversion test
with or without activation (MRID 00039688). A mouse host-mediated assay with Salmonella
typhimurium strain G46 was negative. However, the oral gavage dosing of the mice up to 60
mg/kg may not have been high enough as adequate toxicity was not reported (MRID 00039680).
Non-reproducible increases (just at 2x background) were reported in tiie nonactivated phase of
the Chinese hamster ovary (CHO/HGPRT) gene mutation assay at 100, 150, 200, and 250 uM
(MRrp 00159679). 1,3-D was negative in an unscheduled DNA synthesis (UDS) assay with
primary rat hepatocytes up to consistently cytotoxic doses (> iO"4 M) (MRID 00146467).
Data from the open literature also indicate that 1,3-D is mutagenic in Salmonella and
cultured mouse lymphoma cells and induces chromosomal aberrations, sister chromatid exchange,
Sh'd DNA strand breaks in several mammalian cell lines in vitro. Overall, the data from somatic
cell assays are indicative of a mutagenic concern for 1,3-Dand support the weight-of-the-
lyidence evaluation for carcinogenicity.
ili'i i i iimn i i i i ' i "'I ':':.' ' :"'> ' '"> <"'.' :. ' ! '"
1,3-D was also positive for the induction of sex-linked recessive lethal mutations but not
reciprocal translocations in Drosophila melanogaster (MRID 00146469). To confirm the results
of the Drosophila sex-linked recessive lethal assay, a Data Call In (DC!) was issued for an in vivo
alkaline elution assay in testicular cells (following inhalation administration) on June 17,1996.
The Registrant chose to perform an inhalation dominant lethal assay, which is an acceptable
substitute. 1,3-D tested negative in this assay. Results from this study show that 1,3-D,
administered by inhalation at concentrations up to 150 ppm (ป682 mg/m3) 6 hours/day, 7
days/week for 10 weeks did not induce a dominant lethal effect in male rat germinal cells (MRJD
7jฃ3Q2งo'ty The negative findings of this study lessen lie concern for germ cell effects; therefore,
lib further mutagenicity testing is required. Dow AgroSciences is conducting additional
n n
i ii
14
H^iijiiifs;:
-------
mutagenicity studies for the alcohol and acid degradates; for purposes of this reregistration, EPA
is assuming equivalent mutagenic potential to the parent.
g. Metabolism
An oral pharmacokinetics study was conducted in Fischer 344 rats and B6C3F,i mice. For
the non-protein sulfhydryl studies, the following single oral non-radioactive doses were
administered: 0, 1, 5, 25, 50 or 100 mg/kg. Single oral 14C Telone H doses of 0, 1, 50 or 100
mg/kg were administered for the binding studies. The primary route of excretion for both species
was the urine. The two major urinary metabolites were identified as 1,3-DCP-mercapturic acid
and its sulfoxide (or sulfone) derivative. Following oral administration, most of the radio label
was found in the stomach and gastrointestinal tract with lesser amounts in the kidneys, liver,
urinary bladder, skin, fat, blood and carcass. Oral administration also depleted the non-protein-
sulfhydryl contents of several tissues including the non-glandular stomach (both time- and dose-
dependent). Dose-related increases in macromolecular bindings were noted in several organs.with
the highest binding sites being found in the non-glandular stomach (MRID 00155 846).
In another study with Fischer 344 rats, gavage administration of Telone H at 5 mg/kg/day
for 14 days resulted in rapid absorption from the gastrointestinal tract with distribution to all
tissues examined. Highest concentrations appeared in the non-glandular stomach and urinary
bladder. There was rapid elimination in the urine, feces, and as carbon dioxide in expired air.
Nine metabolites were isolated from urine with two being identified as 1,3 -D-mercapturic acid
and the sulfoxide derivative. No parent compound was present in the urine (MRID 40959801).
h. Dermal Absorption
No dermal absorption studies were required. A waiver was granted for the 21 -day dermal
toxicity study. The current use-pattern does not indicate a. concern for potential dermal exposure.
i. Epidemiological Data
The following data bases have been consulted for the poisoning incident data on the active
ingredient 1,3-dichloropropene.
(i) OPP Incident Data System (EDS)
The incident data system contains reports of incidents from various sources, including
registrants, other federal and state health and environmental agencies, and individual consumers,
submitted to OPP since 1992. Reports submitted to IDS represent anecdotal reports or
allegations, unless otherwise stated. Typically, no conclusions can be drawn implicating the
pesticide as a cause of any of the reported health effects. Nevertheless, with enough cases and/or
enough documentation risk mitigation measures may be suggested. No specific information on
4,3-D was found.
15
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(ii) California Department of Food and Agriculture
(superseded by the Department of Pesticide Regulation
:!;i ; ';*: '" ini99i) [
California has collected uniform data on suspected pesticide poisonings since 1982.
Physicians are required, by statute, to report to their local health officer all occurrences of illness
inspected of being related to exposure to pesticides. The majority of the incidents involve
.i^riSrs."'^ type of illness "(systemic, eye, skin, eye/skin
and respiratory), likelihood of a causal relationship, and number of days off work and in the
hospital are provided.
(iii) National Pesticide Telecommunications Network
..lie,1' s. (NPTN)
'" iii-iM ,J '. :<;, nii i ; ;; i :;". '>',::: : .. ;*' . .j . . .: ; . - .'. ,",i'.1
NPTN is a toll-free information service supported by OPP. A ranking of the top 200
activeingredients for which telephone calls were received during calendar years 1984-1991,
=|nphisiye haj been prepared. The total number of calls was tabulated for the categories human
^
(iv) Summary/Conclusions of Epidemiology Data
From the review of Cajifornia data on suspected 1,3-D poisonings, it appears that a
majority of incidents involved illnesses or injuries to workers who applied 1,3-D as a soil fumigant
jn, fields. A large proportion of the cases occurred when workers were preparing, operating,
cleaning, or repairing application equipment; however, label changes since 1992 have been
adopted which may have prevented reported exposures. Some individuals with inhalation
exposures have reported symptoms such as headache, chest pain, fatigue, irritability or difficulty
concentrating, persisting for as long as two years after initial exposure.
Accidental ingestion of 1,3-D (concentration and amount unknown) has led to one
reported fatality. In a cluster episode, two of nine firemen developed lymphoma six years after
exposure to a 1,3-D spill. Other data or evidence from other epidemiologic studies would be
needed before an association can be supported.
2. Dose-Response Assessment
. "'TS ';'.- a. ''" Determination of Susceptibility to Infants and Children
Under the Food Quality Protection Act (FQPA), P.L. 104-70, which was promulgated in
1996 requires the EPA to "ensure that there is reasonable certainty that no harm will result to
infants and children" from aggregate exposure to a pesticide chemical residue. The law further
states.that in the case of threshold..effects,for purposes of providing this "reasonable certainty of
no harm," an additional tenfold margin of safety for the pesticide chemical residue and other
sources of exposure shall be applied for infants and children to take into account potential pre-and
-16
-------
post-natal toxicity and completeness of data with respect to exposure and toxicity to infants and
children. Notwithstanding this requirement for an additional margin of safety, the Administrator
may use a different margin of safety for the pesticide residues only if, on the basis of reliable data,
such margin will be safe for infants and children. , _
1,3-D is a non-food use pesticide and therefore no tolerances or exemptions from the
requirement of a tolerance are required. Although the FQPA's requirements are directed towards
tolerance actions, the Agency has reviewed the requirements of FQPA as if 1,3-D were
undergoing a tolerance review. '
There are no data gaps for the assessment bfincreased susceptibility to infants and
children from exposure to 1,3-D. The Agency has reviewed acceptable prenatal developmental
toxicity studies in rats and rabbits and an acceptable two-generation reproduction study in rats
following inhalation exposures. The data provided no indication of increased susceptibility in rat
or rabbit fetuses following in utero exposure to 1,3-D. No developmental toxicity was observed
at the highest concentration tested in the pre-natal developmental tbxicity studies in rats and
rabbits tested. No offspring toxicity was seen at the highest concentration tested in two
generation reproduction toxicity study.
The Agency has determined that the 1 OX additional safety factor for the protection of
infants and children (as required by FQPA) is not warranted and has been.removed based on the
following factors:.
i. No evidence of developmental toxicity was seen in the prenatal studies in-
rats and rabbits and no offspring toxicity was seen in the postnatal toxicity
:.'. study in rats following inhalation exposure to 1,3-D; \ .
11.
Ill:
IV.
There was no evidence of abnormalities in the development of the fetal
nervous system in the pre/post natal studies submitted to .the Agency;
The toxicology database is complete;
There is adequate data to conduct exposure assessments.
b. Acute Dietary
EPA has reviewed the available toxicological data for 1,3-D and concluded that the data
do not indicate any evidence of significant oral toxicity from a single exposure event. Therefore,
the acute dietary risk assessment for a-single event high end dietary exposure is not required.
c. Chronic Reference Dose (RfD)
, An RfD of 0.025 mg/kg/day was determined based .on the NOEL of 2.5 mg/kg/day
established in a 2-year dietary admix (microcapsules) study in rats (MRID 43763501) and using
' . ' 17 , ; ' ' ' ' ' .
-------
, e. Occupational and Residential Exposure
EPA has identified the dose/end points to be used in the risk assessment for occupational
and residential exposures. The current use-pattern does not result in exposure through foods
grown in 1,3-D-treated soils; however, due to the potential contamination of ground water and
consequently drinking water, the Committee has identified doses and endpoints for use in risk
assessments for potential ground/drinking w.ater exposures. The current formulations and
application methods indicate a potential for occupational or residential exposure primarily via the
inhalation route. Little dermal exposure is expected when 1,3-D is used according to label
directions, and therefore dermal exposure is not a concern at this time. Doses and endpoints
identified are for both drinking water and inhalation exposures (occupational and
residential/bystander).
(i) Bermal Absorption
No dermal absorption studies were required. A waiver was granted for the 21-day dermal
ity study. The current use-pattern does not indicate potential dermal exposure.
(ii) Inhalation Absorption ,
toxici
1-,3-D has been tested extensively by the inhalation route. Therefore, inhalation'endpoints
are available for risk assessment and route to route extrapolation is not necessary. For this risk
assessment, EPA assumes inhalation absorption to be 100 percent
: (iii) Acute Dietary
EPA has reviewed the available toxicological data for 1,3-D and concluded that the data
do not indicate any evidence of significant oral toxicity from a single exposure event. Therefore,
the acute dietary risk assessment for a single event, high-end dietary exposure is not required.
(iv) Short Term Occupational/Residential
EPA has reviewed the available 30-day inhalation studies for 1,3-D and concluded that the
data do not indicate any evidence of significant toxicity from repeated exposure of up to 4 weeks
duration. No effects were seen in either a rat or a mouse study. Therefore, no endpoint was
identified. The short-term occupational/residential risk assessment for 1,3-D is not required.
(v) Intermediate Term Occupational and
Residential/Bystander (1 week to several months)
For inhalation, the NOEL of 0.091 mg/L (20 ppm) will be used and is based on
histopathological lesions in the olfactory region of the nasal cavity at the LOEL of 0.272 mg/L
(60 ppm) in a 2-year combined chronic toxicity/carcinogenicity inhalation study in F344 rats
(MRID 40312201). The 90-day (MRID 00146461) and 2-year inhalation studies were used in
''.'' 19 . . ;'
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conjunction to determine this endpoint. For intermediate term exposures, 90-day tests are
generally used; however, the dose selection from the 90-day study (10 ppm, 30 ppm, 90 ppm, 150
ppm) did not allow for selection of an appropriate NOEL when compared to NOEL's seen in
Other studies. EPA concluded that had the 20 ppm dose been used in the 90-day study, this
would likely have been the NOEL, and thus selected the NOEL of 0.091 mg/L (20 ppm)
esfablisheH in tfie 2-year chronic study.
IIS'
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(vi) Chronic - Occupational and Residential/Bystander
iSi I'',(' i,,;-'!,1,'. :."i';.' i iiiS ":;' ' I : :' ,
No chronic inhalatipn exposure is expected for 1,3-D. The current use pattern results in
exposure for no more than 3 weeks at a time, generally only once a year. Therefore, no chronic
^qnTcan.cej,endpoint was selected and this risk assessment is not required.
",., ';' ." Y:;" (vu) Office of Water Health Advisory for 1,3-D
EPA's Office of Water has established a Health Advisory for 1,3-D at 0.2 ppb. This is the
consumed daily over a H^me thk is associated with a 1 x W"6 cancerrisk. .The,,
Heath Advisory, however, is only advisory in nature and is not enforceable. There is no
Maximum Contaminant Level (MCL) for 1,3-D.
(viii) Risk Assessment Endpoints for 1,2-Dichloropropane
-: , ; . .. :,;;, .. ; , . ; (Impurity)
1,2-Dichloropropane (1,2-D) is of interest because it is an impurity found in Telone
products (0.06 to 0.1% by weight) and has been shown to migrate to ground water and persist for
many years. EPA has not conducted a formal evaluation of the toxicology database for 1,2-D at
ithis time^ecau^^ 1,2-D has been
evaluated by the Office of Research and Development (QRD) to SUppOrt development of the
Drinking Water Criteria Document for the Office of Water (USEPA 1987). ORD evaluated the
limited available database for 1,2-D and concluded that the liver was the principal target organ of
toxicity. ORD also found effects from acute exposures; the effects were seen in the lungs, liver,
kidneys central nervous system and eyes. A more detailed description is on EPA's IRIS data
base. , , , ,
Sul^hrpnic oral exposure to 1,2-D resulted in liver congestion, hepatic fatty changes, and
liver necrosis in rats receiving 1000 mg/kg/day, 5 days/week for 13 weeks. Mice showed slightly
depressed body weight after treatment with 500 mg/kg/day1,2-D for 5 days/week for 13 weeks.
'i ,,-"' , :
EPA's Office of Water has established a 10-day health advisory for children of 0.09 mg/L.
This health advisory is based on the following assumptions: 10 kg child, consumption of one
L/day of water, all exposure comes from water (i.e., no ambient inhalation exposure), and a health
advisory value based on 7-30 days of exposure. There is also a Maximum Contaminant Level of 5
ppb established by EPA's Office of Water.
20
,.' .iJiiiii.1,,,:, ...iiii'" ,
-------
1,2-D has been classified as a Group B2, probable human carcinogen, with a Qx* of 3 .69
xlO'2 (mg/kg/day)-1 based on the statistically significant increased incidence of hepatocellular
adenomas and carcinomas in male and female B^^ mice. In addition, a dose-related trend in
mammary adenocarcinomas was noted in female F344 rats. This is considered significant because
F344 rats have a relatively low background incidence of these tumors (FR 56(20):3 540 (January
30, 1991). In addition, 1,2-D was mutagenic in the Salmonella and in Asoergillus nidulans. 1,2-
D also induced sister chromatid exchange and chromosome aberrations in Chinese hamster ovary
cells.
(ix) Endpoints for Degradates
Two degradates of 1,3-D have been found in groundwater: 3-chloroallyl alcohol and 3-
chloroacrylic acid. EPA has determined that the degradates 3-chloroallyl alcohol and 3-
chloroacrylic acid should be considered to have toxicological equivalence to the 1,3-D parent in
the absence of toxicology data for the degradates (Abbotts 1997). For the water cancer risk
assessment, the 1,3-D oral Qj* will be used to estimate risk for combined exposure to parent and
degradates. In addition, the levels of the degradates found in the ground water studies will be
combined with 1,3-D levels to calculate non-cancer risks. The oral Q:* for 1,2-D will be used to
calculate cancer risk for this contaminant, but 1,2-D risks will not be added to 1,3-D risks to
develop a cumulative risk assessment. A summary of toxicological endpoints for 1,3-D and its
degradates of toxicological concern are presented below in Table 3.
21
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Table 3. Summary of Toxicological Endpoints for 1,3-dichloropropene and Related Compounds
1,3-D
Exposure Scenario
Intermediate
Residential/Bystander
Inhalation Exposure
Clironic Drinking Water
Exposure
Lifetime Inhalation (Cancer)
Lifetime Drinking Water
(Cancer)
Toxicological
Endpoint for Risk
Assessment
Inhalation NOEL =
0.091 mg/L
RED = 0.025 mg/kg/day
Q,* = 5.33 X 10'2
(mg/kg/day)'1
Q,* =1.22 X lO'1
(mg/kg/day)'1
Endpoint
Histopathological lesions of nasal
cavity (olfactory region)
Decreased body wt gain and
increased incidence of basal cell
hyperplasia of nonglandular
mucosa of stomach
Lungbronchioloalveolar adenoma
tumor rates in male mice, 3/4
scaling factor, Multistage model
Combined forestomach, liver,
mammary^ thyroid, adrenal, urinary,
lung tumors, Multistage Model, 3/4
scaling factor
Study
2-year combined chronic/
carcinogenicity inhalation
study in F344 rats MRID
40312201
2-year combined chronic
/carcinogenicity study in F344
rats (dietary admix,
microencapsulated
Telone)MRID 43763501
2-year combined chronic/
carcinogenicity inhalation
study in mice MRID
40312300
2-year combined chronic/
carcinogenicity study in F344
rats
MRID 00146469
Dcgradates: 3-chloroalIyl alcohol and 3-chloroacrylie acid
Acute Dietary
Lifetime Drinking Water
(Cancer)
None
In lieu of data for
degradates, assume
potency equivalent to
parent, Qj* =1.22 X
10'1 (mg/kg/day)'1
None
Based on combined forestomach,
liver, mammary, thyroid, adrenal,
urinary, lung tumors, Multistage
Model, 3/4 scaling factor
None
2-year combined chronic/
carcinogenicity study in F344
rats
MRID 00146469
1,2-Dichloropropane (Impurity)
10-Day Health Advisory for
Children
MCL (adults)
Lifetime Drinking Water
(Cancer)
0.09 mg/L
0.005mg/L
Qj* =3.69 X lO'2
(mg/kg/day)'1
Office of Water Value
Based on incidence of hepatocellular
adenomas and/or carcinomas in
male mouse, Multistage Model, 3/4
scaling factor
Office of Water Value
2-year carcinogenicity study in
mice and rats, B2 Carcinogen
(described in EPA 1990)
22
!!!! .. "
-------
3. Dietary Exposure Assessment
.a. Dietary Exposure from Food Sources
(I) Directions for Use
All 1,3-D end-use products are registered for use as a preplant soil fumigation for soils to
Be planted to all vegetable crops, field crops, and fruit and nut crops. Broadcast applications for
control of nematodes and garden symphylans can be made at rates up to 332.5 Ib a.i./A for
vegetable and field crops and up to 344.4 Ib a.i./A for fruit and nut crops. Banded applications
are permitted at rates not exceeding the per acre broadcast rate. Dow AgroSciences has applied
for a new registration for 1,3-D application via sub-surface drip irrigation systems; this application
is under review. Special Local Need Registrations (SLN' s) OR94003 8 and WA94003 8 permit
application to potatoes at a maximum rate of 380 Ib a.i./A: The worker restricted entry interval
(REI) is five days.
A tabular summary of the residue-chemistry science assessments for reregistration of 1;3-
D is included in Appendix B. The conclusions listed in Appendix A regarding the Reregistration
eligibility of 1,3-D uses are based on the use patterns registered by the basic producer, Do;w
AgroSciences. " . ' ' ,'
(ii) Nature of the Residue in Plants
The qualitative nature of the residue in plants is adequately understood based on soybean,
tomato, and sugar beet metabolism studies, and consists of natural plant biochemicals. In studies
with tomatoes and soybeans, no residues of the parent, 3-chloroallyl. alcohol, or 3-chloroacrylic
acid metabolites were detected. .
(iii) Nature of the Residue in Livestock
The qualitative nature of the residue in animals is adequately understood based on
adequate goat and poultry metabolism studies. The levels of radioactivity observed in tissues and
milk at high dosing levels are negligible and suggest that it is unlikely that detectable levels of 1,3-
D residues would occur in meat, milk, or eggs. Therefore, no feeding studies or tolerances are
required for meat, milk and eggs when 1,3-D is used as a pre-plant soil fbmigant in soils planted
to feed crops.
(iv) Residue Analytical Methods
No tolerances .are to be established for 1,3-D residues in/on plant or animal commodities.
As a result of this determination, there is no requirement for the development of enforcement
analytical methods for plant or animal commodities.
23
-------
l!]'1";11' !iiLliH!l'':'i; in!:"',,
HiiUJlh;, ill" ik 'iir
; !'"; ;" Bfj .'if,'v .;^V'/;'^;^;':itv ^./i^i^jishm.enjs,.
VI;",
1,3-D is presently not registered for use in food-handling establishments; therefore, no
residue chemistry data are required under this guideline topic.
(xii) Confined Accumulation in Rotational Crops
An acceptable confined rotational crop study was conducted with wheat, lettuce, and
carrots and radishes. The results were in agreement with those from primary plant metabolism
24
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studies, showing extensive incorporation of radiolabelled,residues into natural plant biochemical
constituents. No plant-back restriction is required.
(xiii) Field Accumulation in Rotational Crops
Given the results of the confined study, field rotational crop studies are not required for
'1',3-D.
(xiv) CODEX Harmonization
.No Codex MRLs are in effect for 1,3-D residues. Therefore, there are no.questions
regarding the compatibility of U.S. tolerances and Codex MRLs. '
(xv) Conclusions
As rioted above, all Reregistration data requirements for residue chemistry have been.
satisfied, and tolerances are not required for 1,3-D use as a pre-^plant soil fumigant. No 1,3-D
residues are expected to occur in plants.
b. Dietary Exposure from Drinking Water
(i) Factors Influencing Drinking Water Exposure
The amount of 1,3-1) found in either ground or surface water is related to its physical and
chemical properties, as well as a number of local environmental conditions, including soil
temperature, soil type, and depth to ground water. 1,3-D, once applied, migrates through the soil
profile. Transport can take 1,3-D down to ground water, laterally through the soil profile or up
from the point of application through volatilization. 1,3-D that is not transported either degrades
or is metabolized by soil bacteria.
, ~~ ( . - ,'"-,' . ' '
1,3-D's mobility in soil is measured by soil adsorption coefficients (Kd's) which range
from 0.23 in loamy sand to 1.09 in clay. 1,3-D has a low adsorption coefficient in a range of soils
and tends to partition preferentially .into water over soil (USEPA 1997). 1,3-D is considered to
be a mobile chemical.
For this assessment, the half life of a chemical in the environment is presented as two
different measurements: (1) the dissipation half-life, which reflects physical transport (i.e.
volatilization) and degradation, and (2) the degradation half-life, which reflects degradation via
biological and chemical mechanisms only. These measurements can be conducted in both the lab
and field.
For 1,3-D, field dissipation studies show half-lives of 1 to 7 days, but laboratory
measurements of aerobic soil metabolism show half-lives of up to 54 days. (Because of 1,3-D's
high volatility, the aerobic soil metabolism is likely a more accurate measurement of 1,3-D's
''''. 25 ''. . : : :
-------
II Illlll
Ill III
'' ill,i ' mini i i ' '.' .' I''1
i ' i, ' i ,1 ' _ i ' , , : .
degradation half-life in soil.) Hydrolysis studies of 1,3-D show that hydrolysis is independent of
| jjppH, but extremely variable with temperatures: longer half-lives are seen with low temperatures
I I '' :' i ,ll||llllii|iil'l!'l! "i VlMI'il i '' > , ,,,,*, ,,
,,, ;h|I(USEPA 1997).
,' ' "i ii'i '" i!;"if,:; > i "::i: Ii -i, ,:.:" .' i i,,,.'wfir .; :ii ""':;-']" if '"if jvซซ ii;iiii-,ซ.'ii:\>'< .-. "^*, f;>vฃ';: <:&!;,; i:,i '.:',''., ' . ! * :.,,; !<::'
The major degradates of 1,3-D in soil are 3rchloroallyl alcohol and 3-chloroacrylic acid,
both of which were detected in the prospective ground water monitoring studies (USEPA 1997).
Information on the physical and chemical properties of 1,3-D's degradates, 3-chloroallyl alcohol
and 3-chloroacrylic acid, are limited; however, the degradates are not expected to be as volatile as
, ,, |,,, : ],,, , , , , , ,, ,: : : :: : ,.,,,,. ซ ',,,,,, | ,, | , . , , | '
iji"nii1".,ซ,! i ii'iii'Sii"!!" ,i"iii'' ' , ,:', ', ','!', '! ji " !j', '"'ill!1 ''11 ซ : '*i ,F f1;' !"'r!i, ii',, ' ''"' "''ii'"""'''i " ' : M'|'!i'', ,'i;"1 i; '': , "' "8, !, 'i, ',,, ' ..!,' ,',",,!' , !i ' ' , I," i '
1,3-D can migrate to gjound water under certain conditions. Extensive ground water
monitoring has been conducted for 1,3-D, and detections have been reported from several states.
However, no infoiination about past 1,3-D usage is available to correlate with retrospective
ground water monitoring data. Results of the Florida ground water prospective monitoring study
suggest that 1,3-D may also migrate to surface water via atmospheric transport, i.e., dissolution
of 1,3-D vapors in surface waters. Surface water modeling suggests 1,3-D can migrate to surface
water via runoff as well. Because of 1,3-D's volatility, it is not expected to persist in surface
waters at high concentrations. The stability and persistence of its degradates in surface waters is
unclear, but they are likely to be substantially less volatile than the parent, and therefore may be
more persistent.
The contaminant 1,2-D has a different environmental fate profile than 1,3-D. 1,2-D is
stable and highly persistent in the environment. The degradation of 1,2-D is not temperature
dependent, unlike 1,3-D. Laboratory studies also indicate that 1,2-D is also very mobile, and that
mobility is inversely proportional to the amount of soil organic matter,
(ii) Drinking Water Standards
1,3-JD isnotcurrently regulatedunder the: Safe^Drinking Water Act, however a Health
Advisory level (HA) of 0.2 ppb has been established for 1,3-D. Because the HA is advisory in
Mture, public water supply systems are not required to sample and analyze for 1,3-D. The 0.2
ippb represents me level of daily consumption over a lifetime associated with a 1 x 10"6 cancer risk.
j;i!!i,1l!!;J!:!\i!l|ill]rf' :., jiJI ,, ซfl'! ,,"|,, ' , " |!,l" , , li1!'1"! ป, '!>* JIIWL .''.i", ,!! , ,;' .'.'''i i i:' , i, V" '!,;""'f1 ป ' '' ,,"" .', , ,'J !i!.,|ll'ป' "/'i1!",,:' ซ,, !'i I !, :: "! - , 'il11!" 'V '!', 'f^al i]ป''',"i" ' ISfflii;1;,',, ' . ,,1'"" ., ,. ' ,i - |P, , " ,, , ,
'i!:;: i 'p'" ^I'j-:, ,,'; i|:| j;;,;;',',. |.' jThe ,,C>f||ce: ^pf Pe^tic^e^pjgrams has deyelpped drinking water Levels of Comparison
(DWLOC's) to capture risk associated with exposure to pesticides in drinking water. A
DWLOC, which is not an enforceable standard, is the concentration of a pesticide in drinking
water that would be acceptable as an upper limit in light of total aggregate exposure to that
pesticide from food, water, and residential uses (if any). The DWLOC came about as part of
EPA's review of pesticides underlie 1996 passage of FQPA, which required EPA to develop a
risk assessment tool to take into account these various exposures.
rivi^^lii"!!:' '.';i! || 1:;!::, ' i'lFor ,1,3-i), EPA has calculated two DWLOC's. For residents who live near treated fields,
; defined at the 3100 feet buffer, &e DWLOC
: are at or greater than 1 x 10* for this population. While the cancer risk estimates at distances
26
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between 3 00 feet up to 800 meters are presented as greater than 1x10"6 (see Table 13), EPA
believes these risks are overstated because the value of all mitigation measures has not been
factored into the assessment, and thus a DWLOC of zero may be overly conservative.
For the general population, defined as residents who live at distances greater than 300 feet
from 1,3-D treated fields, the DWLOC for cancer has been calculated to be 0.3, which is the level
of daily consumption of a pesticide over a lifetime is associated with a W6 risk (see section vi of
this chapter for detailed information on how this number was calculated and its relevance to the
1,3-D risk assessment). ;
The discrepancy between the Office of Water's HA of 0.2 ppb and OPP's DWLOC of 0.3
ppb is explained by the two offices different approaches to risk assessment, In general, the Office
of Water assumes a different exposure level and a higher cancer potency estimate for 1,3-D. In
addition, the DWLOC was generated using cancer data which was developed since the
establishment of the 1987 HA. OPP, OW and EPA's Office of Research and Development are
planning to share the information developed from the Cancer Peer Review (planned for 1999) in
order to coordinate reviews based on the best and most up-to-date data on 1,3-D. OPP has,
however, decided to use the 0.2 ppb HA as the trigger for implementation of risk mitigation in the
tap water monitoring program because it is ah established reference point and because it affords
an extra level of protection should the monitoring program detect 1,3-D and/or the degradates.
The contaminant 1,2-D is regulated under the Safe Drinking Water Act. It has a
maximum contaminant level (MCL) of 5 ppb, and a maximum contaminant level goal (MCLG)
of 0 because it is a B2 carcinogen (USEPA 1990). In addition, the Office of Water has
established a Health Advisory for 1,2-dichloropropane: the 10-day Health Advisory for a 10-kg
child is 0.09 mg/L. The drinking water concentration associated with a W6 cancer risk for a 70-
kg adult is 0.06 mg/L (USEPA 1996).
The Office of Water did not establish a 1-day health advisory for 1,2-D because there
were insufficient toxicological data on acute effects. In 1979, the National Academy of Sciences
recommended an acceptable level of 0.3 mg/L for a 70 kg adult exposed to 1,2-D for a week.
(Hi) Groundwater Monitoring
EPA has reviewed available groundwater monitoring data for 1,3-D (USEPA 1997). The
Pesticides in Groundwater Database (EPA 1992) indicates detections of 1,3-D in Florida, New
York, and Washington following normal field use. This database also reports detections in
California due to point source pollution, and 1,3-D has also been detected in California following
normal use. Small scale retrospective monitoring conducted by the registrant showed detections
in studies conducted in Nebraska, but not in California or North Carolina. There was an
unverified detection in a Washington study and a'fifih study in Florida was terminated after a sink
hole collapsed near the study site. More information on the Pesticides in Groundwater Database
27
-------
'"if 3t*"K ' ซ'
zvmw
nil liili If, Hill ir ,n|l,|in
I1"1!1 iMiiiiiFi'i'1'!,,": :"!'
j'f'tjvf'r -:T;
l,s'jtnii;'.*!*
i mi ซ
' Jlhi I il!< jabels ^aff^r ti^ sta^y was well underway, therefore, the Agency was not able to modify the
Sudy to include how this buffer would affect human exposures with the 100 foot buffer.
|jj||||||l|,!!''j,"l!ll,|iil, i ' .,,"|N,,,,|,I|' I'll,:1',' ' ., Ill' ''I," II ,, 'iHl ,' , ,, "'.il,*!'I, "",I.M,'!'ii'l, , 4:'i' ' ii :,:', .IV- 'Hi '"',1,'lAs, t <;.,,, ปli- f , i,' h',,. . , ,.', ,,,. : , '
ipugh there was one off-site well, these levels can only be used as indicative of a trend, but
loll^ used|^rquantitative risk assessment For on-site wells, the peak 1,3-D concentration
579 ppS, the time-weighted concentration (over an 11 month sampling period) was 134 ppb
for 1,3-D alone and 357 ppb with 1,3-D plus the two degradates. The peak level of 1,3-D found
111 the dpwngradient offsite well was 173 ppb and a time-weighted average of parent plus
fegradates in this well was 26.6 ppb (Carleton 1998, Eiden 1998). The contaminant 1,2-D was
found in all of the onsite shallow and deep wells at concentrations up to 3.9 ppb, and in the offsite
well at concentrations up to 0.9 ppb.
:ง'} ' i: '.I1 ' ill A'...''''A-; ifA1!* "'AIA, ''. 11;; wlAt .VV''1!'^',!^1.. ^V'^'^'C:1 '.-.ittv ']' : , A, -,"A . ,''' :,
Florida Site The Registrant volunteered to conduct small scale monitoring in
Southern Florida because of concerns for groundwater contamination due to the high water table
and soil porosity, and in order to assess whether Telone products could be used without causing
unreasonable adverse effects as an alternative to methyl bromide.
The: Florida study design also evaluated on-site and off-site shallow and deep wells. In
Florida, the majority of residents obtain drinking water from public supplies, which tap into the
deep Floridian aquifer. However, approximately 20 percent of the population in Florida (up to
80% in certain Florida counties) tap private wells into the shallow, unconfmed aquifers.
1,3-D was detected in the Florida prospective study at concentrations ranging from 0.05
to 21.6 ppb in shallow wells (screened at a 10 feet depth) not used for drinking water and up to
one ppb in wells that tap into a confined aquifer (screened at a 70 feet depth) which could be
28
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used for drinking water. In Florida, total 1,3-D residues (parent + degradates) in ground water
were detected up to 43.9 ppb in the shallow wells (10 feet deep), and up to 8.9 ppb in the deeper
wells (70 feet deep). The time-weighted, averages (1,3-D plus degradates) were 1.15 ppb in wells
at 10 feet from the surface and 0.17 ppb in wells 70 feet from the surface. For off-site wells, the
time weighted average (1,3-D plus degradates) was 0.074 ppb.
(iv) Surface Water
Limited surface water monitoring data are available for i,3-D. Ambient surface water
' monitoring was conducted concurrent with the Florida prospective ground water study.
Monitoring was performed at four sampling sites along two perimeter ditches around a 1,3-D-
treated field. 1,3-D was detected above a detection limit of 0.05 ppb in 14 of 20 samples
collected from the two ditches in the first five days post-application (prior to the first runoff
event). Concentrations ranged from 0.07 to 1.8 ppb. The maximum concentration of 1.8 ppb
was the only detection > 1 ppb. No 1,3-D was detected in samples collected from the ditches
after five days post-application. The degradate, 3-chloroacrylic acid, was detected in four of the
20 samples collected from the two ditches in the first five days post-application at concentrations
ranging from 0.09 to 0.15 ppb. The degradate, 3-chloroallyl alcohol, was detected at a
concentration of 0.78 ppb in one sample collected from the north ditch nine days post-application.'
No detections were noted after the first rainfall event. No rainfall events of sufficient magnitude
to generate runoff occurred during the ditch water monitoring.
EPA believes that the 1,3-D found in surface water might have resulted from dissolution
of volatilized compound from the air. A second possible pathway is that the levels in surface
water resulted from a ground water-surface,water interaction.
EPA also used computer modeling to see if 1,3-D use could contaminate surface water
through runoff. EPA used Tier 2 (PRZM/EXAMS) modeling to estimate concentrations of
1,3-D, 3-chlorpallyl alcohol, and 3-chloroacrylic acid in surface water in a small pond one hectare
by 2 meters deep, adjacent to a 10-hectare field. EPA assumed that 1,3-D was incorporated to a
depth of 25 cm below the soil surface. The model simulation included a decay rate from the
parent compound (1,3-D) to the alcohol and acid degradates. Because the environmental fate
data on the degradates is incomplete, EPA used assumptions based on 1,3-D's environmental fate
in generating estimates in surface water through modeling. '
EPA compared a variety of modeled and monitored results to test the veracity of the
model. The maximum reported concentrations of 1,3-D, 3-chloroallyl alcohol, and 3-
chloroacrylic acid detected in the Florida ground water monitoring study were: 21.6 ppb, 13.5
ppb, and 8.79 ppb, respectively. Maximum surface water concentrations of 1,3-D and 3-
chloroallyl alcohol/ 3-chloroacrylic acid (combined) estimated from the PRZM/EXAMS model
were: 1390, and 24 ppb, respectively. The average annual surface water concentrations (based on
a 36 year mean) of 1,3-D and its degradates estimated from the PRZM/EXAMS model were
0.801 ,and 0.340 ppb, respectively. Average annual concentrations of 1,3-D and its degradates in
29
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ditch water from the Florida small-scale prospective monitoring study could not be calculated
from the limited monitoring duration (the maximum concentration of 1,3-D was 1.8 ppb).
'. : : ''. .
i
The discrepancy between model estimates of the maximum concentrations in surface water
and the monitoring data reflect, in part, the fact that they address different transport pathways.
However, the larger problem with the models is that they are not well-suited to track volatile soil
incorporated fumigants through the soil to air and water resources. Based on the data base as a
whole, EPA believes once 1,3-D enters surface water., it degradess rapidly due to its chemical
properties. Thus, the fate and concentrations of the degradates become of primary concern. EPA
does notljaye.a.complete database to determine whether run-off is a significant pathway, and
thus Dow AgroSciences is conducting a run-off study to track whether 1,3-D is available for run-
off. It should be noted that concentrations of the material in the ditch water fell below detection
limits withjn py,g d,ays after application in the Florida study; however, the presence of 1,3-D in the
ditches was not reflective of the run-off process, since no run-off generating rainfall events
occurred prior to its appearance in the ditch water.
(v) Drinking Water Exposure Estimates
/ i '.. i ..:.,..;..- .; ..
Ill 11 l| . III. I III I I I I | ' , l'i . ' ',,;- i ,:',;';,.
pPA is using the results of the Florida and Wisconsin studies to derive ground water
concentrations to quantify exposure to 1,3-D and its degradates in drinking water. EPA has
estimated die^ry exposure to 1,3-D via drinMng water using these study results and a daily water
consumption value 'of'2 "L/daj'for adult malesi'^d f^ajiM with bodyweights of 70 kg and 60 kg,
respectively, and1L/day consumption for infants and children with a 10 kg bodyweight. The
following equation used to estimate exposure to i,3-D through drinking water for adult males is
provided as an example of how EPA calculated exposure to 1,3-D and its degradates in drinking
water:
Exposure (mg/kg/day)
(Adult male)
= fconc'n. ug/LV2L/davฅ 0.001
70 kg adult body weight
Chronic exposure estimates for 1,3:D, its degradates and 1,2-D based on time-weighted
mean concentrations detected in ground water from small-scale prospective studies are provided
in Table 4 below.
30
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Table 4. Chronic Exposure Estimates for 1,3-D, Debates, and 1,2-D based on Time-Weighted Mean Concentrations (TWMC) from Prospective Ground Water
Studies. Exposures are presented in mg/kg/day. ' wiuuuu water
Populations
Adidt males
Adult females
Infants &
Children
Adult males,
Adultfemales
Infants &
Children ,
Adult males
Adultfemales
Infants &
Children
Adult males
Adultfemales
Infants &
Children
Adult males
Adultfemales
Infants &
Children
Compound
1,3-D
3-chloroacrylic
alcohol
3-chloroacrylic
acid
1,3-D +
Degradates
1,2-D
FLORIDA PROSPECTIVE STUDY (365 days).
10-ft wells -
TWMC . .
Pgfl-
0.30
0.31
0.54
"1.15 . ,
0.22
Exposure
8.6x10*
1 x 10"3
3xlO'5
8.8x10*
1 x ID'5
3xlO'5
1.5 xlO-5 .
1.8 x JO'1
5.4 xlO-5
3.3 xltr5
3.8 xlO-5.
1.2 x 10?
6.3x10-'
7.3 x 10*
2.2 xlO'5
70-ft wells
TWMC'
ug/L -
'0.04
, o.n
0.03
0.17
0.06
Exposure
1.1x10-*
*
1.3.x 10*
4x10"?
3.1 xlO*
3.6xlO-6
IxlO'5
8.6x10-'
1x10*
3x10-*
4.9x10*
5.6 xlO*
1.7 xlO'5
1.7x10*
2x10*
6 xlO*
10-ftwells, lOff off-site
TWMC
ug/L
0.026
0.025
0.023
0.074 -
NA-
Exposure*
- ,
WISCONSIN
PROSPECTIVE STUDY
(after 337 days, on-site wells)
shallow aquifer (1 5-22 ft)
TWMC
VS/i-
134
87
136
357
1.69
Exposure
3.8 xlO'3
4.5 x ID'3
LSxlO"2
2.5 x ID'3
2.9 xlO'3
8.7xlOJ
3.9 xlO-3
4.5 xlO-3
1.4 xlO-2
1 X ID'2
1.2 xlO'2
3.6xJO'2
4.9 xIO'3
5.6x10-=
1.7xlOJ
'-noteieseweUswerenotuseaiornsKassessmentpurposes.tterefore.TW^ Us ,
Limited surface water monitoring data from the Florida prospective study suggest that
1,3-D may migrate to surface water by transport pathways other than run-off. However, because
information regarding potential 1,3-D migration to surface water is limited, and because'l,3-D is a
volatile fumigant not well suited to the PRZM/EXAMS model, the concentrations of 1,3-D and
its degradates derived from the model will be compared to drinking water levels of comparison.
That is, they will not be used to quantify a drinking water risk associated with residues of 1,3-D
and its degradates in surface water. '
As noted previously, the Office of Pesticide Programs developed drinking water Levels of
Comparison (DWLOC's) as a way to evaluate the concentration of a pesticide in drinking water
that would be acceptable as an upper limit (i.e. no greater than 1 x 1CT6 lifetime cancer risk or
100% RfD) in light of total aggregate exposure to that pesticide from food, water, and'residential
uses (if any). While there are no exposures from food or residential uses, EPA has decided it is
31
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i ill iin:, i',::'!
1
mi
appropriate to aggregate inhalation and oral (drinking water) exposures. EPA calculated
DWLOC values ''l
Ill U!'"":. -I'. ..... ill,"! ilnilllt '
(vi) DWLOC/l^-D plus Degradates
III; ' ...i" ..'V ' !
Illliil
The RfD for 1,3-D (plus degradates) was used to calculate a Drinking Water Level of
Comparison (DWLOC) for non-cancer, chronic effects. The pWLpCchlDnic is the concentration
of 1,3-D in drink|ng water consumed daily over a lifetime that, as part of the aggregate chronic
exposure from all sources (food, water and residential), occupies no more than 100% of the RfD.
The DWLOCdhrooic for 1,3-D plus the degradates is 875 ppb for the total US population, 750 ppb
for females 13+ years old, and 250 ppb for children. Note there is not an inhalation component
because no chronic, non-cancer endpoint was identified and thus no risk assessment was required.
II I III I II I ,,' '' . '.,'.' '. ,'j. . :: :,:, '
The DWLOCchronic for 1,3-D plus degradates was calculated using the following formula:
' I i i ' ..... i | ;: . ,'''. >' ' ; v : : ''' ,'.'
l . . :^ '. .
= chronic water exposure (1.3-1) + degradates) (mg/kg/dav')(bodv weightkg^
(water consumption, L/day)(10~3 mg/fig)
where chronic water exposure = RfD (because there is no exposure to 1,3-D via food); water
consumption is two L/day for adults and one L/day for children; and body weight is 70 kg for
total US population, 60 kg for females 13+ years old, and 10 kg for children 1 to 6 years old.
The oral Qj* for 1,3-D was used to calculate a DWLOC for cancer effects associated with
exposures to 1,3-D plus the degradates. The DWLOCcanCer is the concentration of 1,3-D in
drinking water consumed daily over a lifetime that is associated with a 1 x 10"6 cancer risk from all
exposures. As noted previously in this document, EPA has developed two DWLOC's for 1,3-D
(plus degradates). Because the cancer risk associated with inhalation exposures at the 300 feet
buffer is above 1 x lp^, me DWLOC for water exposure is zero. Although calculated inhalation
risk estimates for residents who live near treated fields are above 1 x 10"5, EPA believes these
estimates are overstated because all mitigation measures which are on 1,3-D labels have not been
factored into the assessment.
For the general population (those living more than 300 feet from treated fields), the
DWLOC,..,^ for 1,3-D is 6.3 ug/L (ppb)! Because there is no dietary (food) exposure to 1,3-D,
individuals could be exposed to 8.2 x 10"6 mg/kg/day of 1,3-D in drinking water before EPA's
level of concern (lx i 6^ cancer risk) would be exceeded. See section ELD. iv for an explanation
of how EPA calculated risk estimates for cancer and how levels found m the ground water studies
compare to the DWLOC for cancer. As explained in section IE. B.3 b., there is an Office of
Water Health Advisory of 0.2 ppb which differs from the DWLOC of 6.3 ppb .
........... ...... ..... ' " '! ..................................... ........ ; .......... ......... ........ "'" ' ....... ........ ........... ' ............ " "' ....... ' ..... '' ...... "I ' ' ,'-,..
The DWlLOCeancer for 1,3-D was calculated using the following formula:
1 ' !
(chronic water exposure (1.3-D + degradatesX mg/kg/dav)(bodv weight)
(pg/L)(water consumption, L/day)(10"3
32
-------
where chronic water exposure =
1 X IP'*
oral Q!* of 1.22 X10'1 (mg/kg/day)-1,.
water consumption is 2 L/day, and body weight is 70 kg.
(vii) DWLOC/1,2-D.
The oral Qj* for 1,2-dichloropropane was used to calculate a DWLOC for cancer effects
caused by 1,2-D. The DWLOCcancer for 1,2-dichloropropane is 1 ug/L. The inhalation exposure
studies did not monitor for levels of 1,2-D in air, therefore, the DWLOC only estimates oral
exposures. , . ' ' ,
The
(Ug/L)
for 1,2-dichloropropane was calculated using the following formula:
- (chronic water exposure. mg/kg/dav)(bodv weight
(wafer cpnsumption, L/day)(10ฐ mg/ug)
where chronic water exposure =
1 X IP"6
oral Qt* of 3.69 X lO-2 (mg/kg/day)-1-
water consumption is 2 L/day, and body weight is 70 kg.
DWLOC's can also be compared to model estimates as a surrogate way to estimate and
characterize risks. Using PRZM/EXAMS as a model, EPA devised three scenarios to give 36-
year mean concentrations for 1,3-D and its degradates in pond water and compared those to the
DWLOC's for chronic (RfD) toxicity endpoints. DWLOC values were calculated for chronic
(non-cancer) effects for three subpopulations (U.S. population, adult females, and children and
infants), and calculated for cancer effects for the general U.S. population. Table 5 below provides
a comparison of the model estimates for three scenarios from Idaho, Mississippi and Georgia to
the DWLOC values for the general population..
Table 5. Estimated Concentrations of 1,3-D, 3-chloroaUyl alcohol, and 3-chloroacrylic acid in Pond
Water (PRZM/EXAMS)
Subgroup
US Population
Females
Children &
Infants
DWLOC
chronic
ftltr/T -\
875
' 750
250
36-Year Me'an (ug/L)
Potatoes (ID)
0.045
0.016
0.061
Tobacco (GA)
0.357
0.081
0.438
Cotton rMS^
0.801
0.340
1.141
Note the DWLOC for the cancer endpoint is 0.3 ppb, which would be exceeded for all
groups from the MS scenario and for all but females in the GA scenario.
33
-------
til* ::
I ".. " .'.
it! iltjJJW
However, EPA does not expect 1,3-D concentrations to persist in surface waters long
enough to provide chronic exposures and recognizes that PRZM/EXAMS is not well suited to
tracking volatile fomigants. Estimated average concentrations of 1,3-D and its degradates, alone
or in total, are well below theDWLOC's for chronic, non-cancer effects for the subpopulations of
concern. Estimated concentrations of 1,3-D, per se, are greater than the DWLOC for cancer
effects |n|w that the degradates, being less
|yolatile than the parent compound, may persist-in surface waters. Dow AgroSciences is
developing environmental fate and run-off data to show whether the degradates persist to pose
chronic risks.
C. Occupational and Residential Exposure
i. Summary of Use Pattern and Application Methods
There are no homeowner products containing 1,3-D. 1,3-D is a restricted-use pesticide
and thus only certified handlers are allowed to load and apply 1,3-D.
1,3-D is applied by injection below the soil surface at least 12 inches. The liquid 1,3-D
then diffuses through the soil spaces. 1,3-D may be degraded while in the soil or it may volatilize
f ^'migrate to grbundwater. Occupational and residential/bystander inhalation exposure occurs as
a result of 1,3-D volatilization. Inhalation is the primary route of exposure for workers. The rate
of 1,3-D volatilization is affected by application method, soil sealing method, soil composition
(e.g, amount oFclay and organic matter), and soil moisture, temperature and a variety of other
local environmental factors.
J !
1,3-OD is applied to soil by two methods: row and broadcast. \Vith both methods, 1,3-D is
injected 12-18 inches below the final sealed soil surface. The broadcast method uses one chisel,
l^pbel ^sweej)} glow or plow-sole application equipment with one or more fumigant outlets. The
broadcast method' requires trie formation of a raised bed after the application. The row method
consists of either one or two chisels per plant row to treat a band of soil where the crop is to be
planted. The row method involves forming beds at the time of application so that the fumigant is
placed at least 12 inches from the nearest soil/air interface.
1,3-D products do not require mixing, and are loaded into tanks which are attached to
tractors or application rigs directly from a bulk or mini-bulk container. Bulk loading from tanker
trucks is the predominant practice where custom applicators are the biggest users (e.g., the Pacific
Northwest). Mini-bulk systems are portable 1000-gallon "traveler" cylinders with dry disconnects
to prevent 1,3-D leaks. After applying 1,3-D, the user returns the mini-bulk container and any
remaining 1,3-D to the local distributor, who then sells the remainder or returns the mini-bulk
container for cleaning (note: cleaning and maintenance of bulk and mini-bulk containers are
regulated by OSHA and are not included in this exposure assessment).
34
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2. Exposure Mitigation Measures in Effect
\ ' ' , " f
Since 1992, numerous mitigation measures have been added to all 1,3-D product labels.
Specific mitigation measures for workers and area residents are described below.
a.
Workers
The following table presents label measures that are in effect to reduce exposures to
workers through the dermal and inhalation routes of exposure. The largest sources of worker
exposure, through leaks and spills, were addressed by the use of closed loading, equipment to
shut off 1,3-D flow at row-turns and respirators.
Table 6. Summary of 1,3-D Label Restrictions that Impact Worker Exposures
Regulatory Action
(effective date)
Registration Standard
(1986)
Label Requirements
Precautionary Statements; Cancer Hazard Warning; Classification
Change to Restricted Use Pesticide; Reentry increased to 72 Hours*;
Clothing for Applicators and Handlers (Coveralls*, Chemical-resistant
Gloves and Boots, Liquid-proof Hat). ' '
1992 Label Amendments
(1992/1993)
Lowered Maximum Rates; Deletion of Selected Use Sites; Revised,
Respirator Requirements*; Closed Loading.Requirements; Technology
tp Minimize 1,3-D Spillage during Application, Improved Product
Stewardship Materials '
Worker Protection Standard
(August'1992
see 57 FR 38102)
Coveralls Over Short-sleevecl Shirt and Short Pants; Chemical-resistant
Gloves and Footwear; Chemical-resistant Apron (for Direct Handlers).
1995 Label Amendments
(1996) ,
A Respirator Requirement for All 1,3-D Handlers (Except Those in
Certain Closed Cabs); Restricted-Entry Increased to 5 Days; Soil
Moisture and Soil Sealing Requirements; Modified Application
Techniques and Lower Maximum Use Rates.
* Superseded or modified by later label measures.
b. Residents/Bystanders
1,3-D labels require a 300 foot buffer zone between treated fields and an occupied
structure where 1,3-D applications are prohibited. Other measures listed in the table above,
including use of the "traveler" mini-bulk loading system, reduced application rates, increased
injection depth, soil sealing, and soil moisture requirements, are also expected to reduce exposure
to residents and bystanders, although exposure reduction cannot be quantified (Carleton 1996a):
35
-------
Illlllllll 111 111 III 1111
ifH t;;i4i
I sin .t'f'^iiuii
Ill 11 PI II I III I 111 I I 111 llli ! WlSiP *(j WWRtp* Vปฅ' , :Kl!Pl ^WW.V'IW ">i>i\! "*.ซ: "! WtiS '"S'i IS,-:; :1Sfi< < ;:/ |" ' >:; ! i1 .';, : <, i '", ' '' ' >':'' i- - '"'
mil 11 i|i || Jii " -, .' ;'. lh -1/;" lit";1::!!,;,,;-'' I?1''"i- ;,'"''"/ -SiiiinL1"1,;, .i, ii-?. ..-i,-'..'.; /:"i""l'i':ii;ii.11i''li i;ihi:!"i:1i'i. -!-* .:i: i'1"',;-.I1,, i1 " ,.',',
3. Factors Influencing 1,3-D Exposure
The label measures described above reduce, but do not do not completely prevent, 1,3-D
||,i|i i nil ^ i iiii y.f.'i'. r.'tfn'^ii'ianiwi'i ,H s iiMimiyi ..riHH' T<^ n ; > -: ..' i->', :&&>*;. ft,: ~ , J f . , ,~ ' ,
releases into the atmosphere. EPA believes that the greatest potential for release under current
labels is through the chisel trace that is left as 1,3-D is applied, and through off-gassing that
occurs for several days after application. For this route, local environmental conditions greatly
influence inhalation exposure to agricultural workers and residents/bystanders, iocal soil
conditions, such as soil type, moisture, organic content, and soil temperature all influence the rate
of 1,3-D volatilization and subsequent exposure to workers or residents. 1,3-D product
application methods, including soil sealing, injection depth, and placement of injection shanks
influence the volatilization of 1,3-D. Local meteorological conditions, such as prevailing wind,
also influence air concentratipns and exposure potential. Application rates may also influence
1,3-D volatilization, although a^quantitativerelationshipbetween application rate and air
concentration has not been established. In addition, 1,3-D air concentrations may vary with time
after application. Peak 1,3-D volatilization generally occurs over the first 72 hours following
J,3-D application, although detectable levels are still present 14 days following application.1
1?3-D exposure also varies with distance from treated fields. 1,3-D air concentrations measured
125 meters from treated fields were 45 to 72 percent lower than air concentrations measured five
meters from treated fields (Carleton 1996). ,
$!; 'V ';"'': '7-,:' '*ฃ','' Exposure Monitoring Studies
i i
Dow AgrpSciences performed exposure monitoring studies for both workers and for
residents who live near treated fields. Most of these studies were required by the 1992 DCL An
additional worker study on 1000 gallon mini-bulk "travelers" was submitted by Dow
AgroSciences in 1995, which was incorporated into the worker risk assessment, but not the
residential assessment Studies used for the EPA Worker and Resident/Bystander Risk
Assessments are summarized below.
a. Worker Monitoring Studies
, |",' ' , ...,:.',.
Personal air monitoring was conducted for product loaders, applicators, and re-entry
workers (MRID's 42946201,42845602, and 4880401). Air samples were drawn through
activated carbon sprbent tubes, using battery operafed pumps to collect air from the breathing
zones ofthe workers at a measured flow rate. Samples were subsequently desorbed in an organic
solvent and analyzed by GC-ECD or GC-FID. For the loaders and applicators, two kinds of
samples were collected: four hour samples, and task-specific short duration (4 to 46 minutes)
samples. The'four hour samples provided inherently time-weighted average air concentrations
over a major fraction of a work day, while the task-specific samples measured the air
concentrations associated only with high-contact activities. For product loaders, these activities
l|l| |ll |l liji!,1!!!1'i."" Jihif"',,, .!:'; Jliillini' >l Ms1;:" !',i,,i!ii!i*,,,r !,;ii| ''i!!'1' irs": , !", , -fTii; r, in* .,,:,' .'in, , H" ., a,., ' iiv ii ',,:.,.* I*,', ,
-------
time spent on site between loading events. In the Ainger, NC worker monitoring study, only
short-term'task specific samples were collected. Sampling occurred only when workers were
actively engaged in loading. Worker monitoring studies are described below and the data from
these studies are summarized in Tables 7 and 8.
* Moses Lake, WA Worker Study. October and November, 1992. Telone H was
applied at the maximum application rate of 25 gal/acre (252.5 Ibs a.i./acre) on a
field used for potatoes; soil type was sandy loam. Bulk loading was used with dry
disconnects, which are common practice in the region. Application was by the
broadcast method.
Buckeye, AZ Worker Study. March 3-10, 1993. Telone H was applied by the
row method at the maximum rate of 12 gal/acre (121.2 Ibs a.i./acre) to a field used
to grow cotton; soil type was loamy sand. Bulk loading was used, with dry
disconnects. (The study also collected samples without dry disconnects, but these
data were not used for Reregistration because dry disconnects are now a label
requirement.)
>' Ainger, NC Worker Study. April 3-5, 1995. Telone C-17(1,3-D plus
chloropicrin) was applied by the row method at a rate of approximately 10 gal/acre
(82 Ibs a.i./acre) to a field used to grow tobacco. Soil type was not specified. This
study utilized the mini-bulk delivery system, Dow AgroSciences' portable 1000-
gallon "traveler" cylinders, which utilize dry disconnects. End row spill control was
also used in this study.
Not all available worker monitoring data were used for exposure assessment. Only data
reflecting the label requirements current at the time of testing were used (e.g., respirators, dry
disconnects, end-row spill control).
Biological exposure monitoring was also conducted on both sedentary human volunteers
(controlled study) and on workers performing typical tasks. Urinalysis was used to detect the
major 1,3-D metabolites (Levy 1993, McMahon 1993). These studies are described in detail in
the worker exposure assessment for 1,3-D (Mehta 1994b). The biological monitoring data were
not used in this risk assessment because an accurate correlation between urinary metabolite
excretion and the air monitoring data could not be made to estimate absorbed dose (McMahon
1993). The biomonitoring data showed 1,3-D absorption in the range of 72-82 percent; these
absorption estimates were determined to be minimum values after comparison with field trial data.
Absorption via the inhalation route was assumed to be 100 percent for the purposes of this risk
assessment. '
b. Resident/Bystander Monitoring Studies
The NC, AZ and WA studies (MRID 42845601) included off-site monitoring to assess
exposures to residents who live near treated fields., Residential/bystander monitoring studies
''" 37
-------
I
I
ซ!!!.
I
'ป'
i-'iffi'
'hM^'W '
involved air sampling for 14 days at various stations 5,25, 125, 500 and 800 meters from a 1,3-
P^ej^ additional sampling stations at 1200 and 1600 feet for the AZ site). Prior to
'.,.', ',' |||ie ijjiifiatio|i ^th^freatoenj, baseline air samples were collected at sampling stations located 500
'ineters'from the treatment sites. The applications were conducted utilizing standard cultural
practices and equipment at the time of the study. Fields that were selected and treated were
isolated from all other known 1,3-D handling activities. Air sampling was conducted in all four
'':' 3|6i|ip||ง directions. EPA analyzed data for samples taken downwind from treated fields, as' well
jj^jlir. pooled data from all four directions (to account for snlfts in wind direction). Air sampling
li^as CQi}ducte '", Hi i , i i I . :' ''. '' ' I '" 'iV,:,,':
At the Washington study site, the presence of a nearby cattle stockyard prevented the
collection of a sample 800 meters south of the treated field. However, at the Arizona site,
samples were collected at 1200 and 1600 meters from the field in all four directions, in addition to
the distances listed above.
Residential/bystander monitoring studies are described below.
Phase 1. MosesJLakej WA? iQctober 26 to November 9, 1992. Air monitoring
was conducted at 20 monitoring locations surrounding a 20 acre plot treated with
Telone IE using the broadcast method at the maximum rate of 25 gal/acre (252.5
Ibs a.i./acre). Prior to the initiation of the treatment, baseline air samples were
collected at sampling stations located 500 meters from the treatment site. The 800
meter south samples could not be collected because a cattle stockyard was located
to the south of the treated field. The soil type was characterized as loamy sand.
i
Phase 2. Harquahala Valley, AZ. February 16 to March 2, 1993. Telone II was
applied using the row method at a rate of 12 gal/acre (121.2 Ibs a.i./acre), imitating
an application for a melon field. Air monitoring was conducted at 28 monitoring
38
-------
locations surrounding the 20 acre plot treated with Telone n. The soil type was
characterized as a sandy loam.
ป Phase 3. Hookerton, North Carolina. December 7-21, 1992. Air monitoring
was conducted at 20 monitoring locations surrounding a 12 acre plot that had been
treated with Telone C-17. Telone C-17 was applied using the broadcast method at
a maximum label rate of 20 gal/acre (164 Ibs a.i./acre) for tobacco. The soil type
was characterized as a sandy loam. ,
Monitoring data from these studies are summarized in Table 7 below. Off-site monitoring
results are presented at various distances from treated fields. The monitoring data showed that
1,3-D air concentrations peaked during the first three days following treatment and then declined
over a period of 14 days following treatment, which was the duration of the air monitoring. Data
from the resident/bystander study are presented in a way that captures this peak. Data are
presented as (1) the maximum 4-hour air concentration during the study, measured during the first
few days of treatment, (2) mean 24 hour air concentrations, (3) mean 7-day air concentrations,
and (4) mean 15-day air concentrations. -
For each sampling station, the time weighted average (TWA) air concentration was
calculated for the appropriate sampling period. This consisted of the arithmetic mean of the mean
daily air concentrations. For all except the on-site samples, this calculation included the
concentrations measured during the application process. For each distance from a treated field,
the mean TWA over all four directions (N, S, E, W) was calculated for the appropriate
monitoring period. The data for all three sites was then pooled, and an overall average for each
distance was calculated for the entire data set.
Table?. 1,3-D Air Concentration Monitoring Data for Agricultural Workers -
Activity .
Loading a
Loading2
Loading3
Application11
Sample Duration
4hr
task only
task only
4hr&task
Study sites
WA,AZ
WA^AZ
NC
WA,AZ,NC
Total reps.
10
10
12
28
Air Concentration (ng/m3)
Range
' 177-5932
526-32490
52-1 18'0 .
43-6581
Mean
1,631
.10,833
464
1,359
Median
623
4,860
442
1,150
"With use of dry disconnects .
bWith use of end-row spill control
39
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Table 8. Offsite Air Monitoring data
Distance
from treated
field (m)
1600
1,200
800
500
125
Edge of
buffer zone
25
5
onsite
,!.. , !'
Study Site
AZ
AZ
AZ
WA
NC
AZ
WA
NC
AZ
WA
NC
AZ
WA
NC
AZ
WA
NC
AZ
WA
NC
" ". ' ,"'ซ' B , !!" ' '
'.ii , ILMIlilil " ;' ' ' '! ''
Max. 4-hour
cone.
(ug/m3)
90.9
157.7
215.9
171.9
63.2
482.2'
183.0
92.1
1709.5
521.3
281.0
3575.5
311.7-
394.3
1592.6
351.0
671.2
2316.4
351.0
339.9
..'..:1.1!v;:'rS*','v.,
f '*!,""! !,' ,!ii ,!' i,
Max cone.
24 hour TWA
(ug/m3)
23.3
46.0
62.9
79.7
10.8
140.4
91.7
16.0
579.3
278.2
58.0 .
1807.0
212.2
222.9
1278.2
235.5
343.7
*
1067.1
266.2
261.9
-:imi. m"
Mean cone.
7 day (ug/m3)
numbers in
bold indicate
mean levels at
that distance
for the 3
studies
3.2
5.6
9.7
21.0
1.4
10.7
18.6
24.1
2.2
15.0
92.0
55.0
10.4
52.5
196.0
74.9
26.2
99.0
184.8
91.7
38.3
104.9
315.4
151.3
75.6
180.8
1 '-ii!:' :',r' ,; \ vi ^l'1' "i! '"i1
Mean cone.
15 day (ug/m3)
numbers in
bold indicate
mean levels at
that distance
for the 3
studies
2.4
3.8
6.5
14.6
1.3
7.5
11.8
17.2
1.5
10.2
55.6
40.2
6.0
33.9
112.4
62.1
15.1
63.2
104.7
73.6
21.7
66.7
171.1
115.5
40.4
109.0
I* ';' '
5. Exposure Estimates Used for Risk Assessment
i
EPA based its risk assessment on 1,3-D air concentrations measured in the monitoring
studies described above. Only inhalation exposure was estimated; dermal exposure is expected to
be negligible because of 1,3-D's volatility and the protective measures on 1,3-D product labels.
40
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Because the number of monitored replicates at each site was small (5 to 13), EPA pooled
the results from different sites to obtain the largest possible sample sizes for each exposure
scenario. Tables 7 and 8 present a summary of the pooled data on air concentrations from these
studies. ,
?, . - ...-'- '-
For intermediate-term worker exposure, the 4-hour samples were used to calculate the
mean air concentrations over all pooled replicates. Separate inhalation exposure estimates are
provided for custom loaders and applicators, because different individuals perform these tasks.
However, for growers, EPA assumed that the same person conducts both loading and application
of 1,3-D. Since growers presumably spend most of their work day engaged in application rather
than loading, intermediate-term exposures estimates for growers were based on the air
concentration for application rather than loading. All worker air concentration estimates were
adjusted using a protection factor of 0.10 for respirators.
For intermediate-term residential/bystander exposure, a time weighted average (TWA) air
concentration was calculated for the first eight days of exposure only (day of application and the
first seven days of a 14-day study). These are the mean 7-day air concentrations in Table 8, which
were used to calculate intermediate term MOE's.
For lifetime residentialftystander exposure, the TWA air concentration was calculated for
the entire sampling period for each monitoring station. This time weighted average was the
arithmetic mean of the mean daily air concentrations. For all but the on-site samples, this
calculation included the air concentrations measured during the application process. This value
was normalized over a 24 hour period, and incorporated into an overall 15 day TWA (the day of
application plus the 14 days following). Since samples were not collected above the fields during
the application process, the on-site TWA covered only the 14 day period after application.
For each distance from a treated field, the mean TWA over all four directions (N, S, E, W)
was calculated for the entire monitoring period. The data for all three sites were then pooled, and
an overall average for each distance was calculated for the entire data set. These values appear in
Table 8 under the heading of "Mean cone. 15 day" air concentrations. Subsequent cancer
calculations took account of the differing numbers of days used in calculating the mean air
concentrations at the different distances, by assuming 14 days of exposure for the on-site
concentration, and 15 days for all the others. .''
To calculate intermediate-term exposures, a similar calculation was performed, except that
for each distance, a TWA air concentration was calculated for the first eight days only (day of
application plus the seven days following). These values appear in Table 8 under the heading of
"Mean cone. 7 day" air concentrations. Intermediate-term MOE's were estimated as the
intermediate-term inhalation NOEL of 0.091 mg/L (see Table 3) divided by the "mean 7 day"
1,3-D air concentration.
Exposures to agricultural handlers entering treated fields after the five day REI were also
calculated using the on-site air monitoring data from the residential/bystander studies. For each of
. 41 '
-------
;'1 ! I'
"
I . IWK'lirJS'
the three monitored sites, the TWA 1,3-D air concentration was calculated for the period
consisting of days 6-14 post-application. The resulting concentration was used to estimate cancer
to handleis, entering treated fields.
ill" ' is . . . tj ' " , ,';' ', ..IL, It Hi , fiji"1 "; ! l|; ,;., ili'i" ' :!'., * :"!"i ' I!'11":,* * ' ;lt. '\ ' it : t ' ...... ป' i(:',1i'j.! : ,1 ..... j '' t; ,..ฃ." ,"1'1 t; '! ",> '<>i liiiL '*, ', 'J, f, 'it . |i , , '" ,''''", " ,
Chronic, lifetime exposures to workers and area residents were expressed as lifetime
average daily dose (LADD). The LADD of 1,3-D was calculated according to the following
JTormula: ..................... ......... ................... ........ ' ........ . ,, ..................... . ...... ., , ...,.'
LADD (mg/kg/day) = [(air concentration, ug/m3)(mg/1000 fjg)(ventilation rate, m3/hr)(hr/day)
(days/vrVl vr/365 daysYvrs exposed/70 vrs^l _
,:, - _ , . ,, ,, . ,,,. , .......... ,. , _,, 70 kg body wt
using the following values for workers and residents/ bystanders:
Workers Residents/Bystanders
',n : ........ ' :i',i ill! ...... i : i ........ , ,' ป > Mi," : ........ ,il ,!: ..... ' ' , ' ...... I"',,, v :'i:!; , ,!!', ,'Kr , ' ' ,,' ' " ' ' i " i '
Ventilation rate 1, 74 m3/h (light work) 0.81m3/h
>E 'A;
Lifetime Exposure
1,1 " i t i
Average Lifetime
Exposure Duration
Exposure Frequency
30 years, grower,
20 years, commercial
70 years
crop specific
crop specific
30 years
70 years
16h/day
15 days/event, 1 events/yr
I _ 111 i i F I | ,; ' i," i , i , i ; , "
LADD's for commercial "for-hire" handlers were calculated by first estimating average
daily doses (ADD's) in mg/kg/day, from the air concentrations. Information on days per year and
hours per day were obtained for each crop, state by state, from Dow AgroSciences1 Use and
Usage Summary Report. However, for loaders, the report lists only the total hours per day spent
actively engaged in loading (0.5 to 1.25 hour/day), not total hours spent on site. To estimate
ADD's, the Agency therefore assumed loaders to be on site for the same number of hours per day
as the applicators (5 to 10 hour/day, depending on state and crop).
LADD's for growers assumed that the majority of the work day is spent applying 1,3-D,
arid only as much time as is required to load the tank is spent engaged in loading. Therefore, the
4-hour samples were used in the calculation of the portion of the exposure resulting from
Implication, and the task-specific samples were used' to calculate the exposure incurred while
loading (because 4-hour samples were not collected for the mini-bulk study, the Agency made the
ISSffijiption that for the use of mini-bulk cylinders, the task-specific loader air concentrations are
"Ijcperienceci for the duration of a work cycle). The loading and application exposures were then
added to estimate the total exposure for these individuals, information on hours per day and days
per year for each activity were obtained from the Dow AgroSciences' Use and Usage Summary
Report For growers, the Agency assumed that the same person conducts both loading and
application of 1 -3-D.
I'liir:!1 * . ?
m>m lit
Nil1 ' ti El : ;'?!"
ii'SB-"
42
111 Si I. t til"" !, '
: H!1!!. i -' Mi
I :,W';
-------
Exposure estimates for residents/bystanders were based on pooled data to account for
random shifts in wind directions. For residents/bystanders, the Agency also assumed 16
hours/day spent in and around the house. EPA assumed 1,3-D air concentrations to be the same
indoors and outdoors, in the absence of indoor air monitoring data. Exposure estimates for
residents/bystanders are provided for individuals who remain at a fixed distance from a treated
field. The LADD for workers was adjusted using a protection factor of 0.10 for respirators.
D. Risk Assessment
EPA expects both occupational .and residential/bystander exposure from the use of 1,3-D.
Residents and bystanders near Telone-treated fields are exposed via ambient air. Dietary
exposure may occur through drinking water, but is not expected from food sources. Exposure
can occur by the inhalation and oral (drinking water) routes, but not is not expected from the
dermal route of exposure based on use patterns and label requirements for 1,3-D use.
i . ' , '
,1. Dietary Risk and Characterization
a.
Food Source
No dietary risk assessment was performed for l;3-D, because no residues are found in
foods. Telone products are pre'-plant fumigants which break down in the soil and thus are not
available for uptake by plants. The at-plant treatment for pineapples shows that the fruit, which
are borne three years later, do not contain 1,3-D treatment-related residues.
b. Drinking Water Source
f - ' " ' "** ' " - ' '
(i) Acute Drinking Risk
No acute toxicological endpoints were identified for 1,3-D exposure for acute or
subchronic time duration. Therefore, no acute or subchronic drinking water risk assessment was
conducted.
For 1,2-D, EPA's Office of Water has a children's 10-day health advisory of 0.09 nig/L
(90 ug/L or 90 ppb). The maximum concentration of 1,2-D found was 1.3 ug/L (Q.0013 mg/L) in
the Florida study and 3.9 ug/L (0.0039 mg/L) in the Wisconsin study. Because the maximum
concentration of 1,2-D found in the prospective ground water monitoring studies does not exceed
the 10-day health advisory for children, it is not considered to be of concern.
The Maximum Contaminant Level (MCL) for 1,2-D is 0.005 mg/L (5 ug/L). The
maximum concentration of 1,2-D in the Florida study on-site wells wasj.3 ug/L in shallow well's
and in the Wisconsin study was 3.9 ug/L. Therefore, the levels of 1,2-D found in the prospective
studies do not exceed the MCL and are not considered to be of concern.
43
-------
r
t* iiiiWif''
: ilillULU , .niiP'li'fi'l
;;1 w !;';'''?w
!, i'Slili' !'ซ..
i iiinriiii in; ii yinv
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I
liilj.J! |M|,< ,;, ,
I'ii1, iiy 'I'LEvi,:'"!.,. ii'iiiniii!'
W'LUnll 'fill !V:l '
(ii) Short and Intermediate Term Drinking Water Risk
For 1,2-D, EPA's Office of Water has established a 10-day health advisory; the
concentrations of 1,2-D in the water monitoring studies were compared to the 10-day health
advisory for 1,2-D. Concentrations of 1,2-D in groundwater did not exceed the 10-day Health
Advisory of 0.09 mg/L or the MCL of 0.005 mg/L and are not of concern. In the Florida study,
the peak groundwater concentration in on-site wells of 1,2-D was 1.3 ug/L (0.0013 mg/L). In the
Wisconsin monitoring study, the peak groundwater concentration of 1,2-D was reported to be 3.9
ug/L (0.0039 mg/L).
Ills! Mi , ?,.M|,|. .. i :,'" ,',; 5iii| ' iP ซ , , , <, i .; m : ,' ii"i,,' ,'ป M, " I, 1- i, I'll, "' ' ' ' , , ' , . ",:i , is,, , ' f '",.' , ป
,'-;!"::: f' V't,:, ill < I' i -:";^ $ (ii) Chronic Drinking Water Risk as % RfD
'i",, ,hi' ,,11': ill!" /nil"!
For 1,3-D, EPA has determined that the oral RfD should be 0.025 mg/kg/day, based on a
NOEL of 2.5 mg/kg/day from a 2-year chronic/carcinogenicity study in rats and an uncertainty
factor of 100,
I'' i I" ijliiu 'i ' ' "'' " "!, i 'p I' H '" ,1, , I ,''''''' ,'"!
fthe chronic drinking water risk is calculated as a percent of the RfD taken up by drinking
"waten As stated previously, groundwater is expected to be the only source for chronic drinking
The following calculation was used:
tH,"!!11 ii i i.1 M'"!";1 i ,,i!",, :' IB',Hi,! ,II,!I'M '" ,;, " ' : " n;,,11 n m1 " ,': , m i" ,i; i ,,.:',' ,"i", >, "i"1 ' ,, i|ป si
% RfD = ( Drinking Water Exposure, ma/ka/dav')
Slit ,' ' ,.' 1,1 'I
RfD of 0.025 mg/kg/day
iifjj: , j* '.';' ^^'.'{'fiviitiOiiilil1';.; .i1"1,!1'!11)11;1!!1!;"1";!",; !i'!!!>!: T1 .">'"' ;;
X 100%
Time-weighted average ground water concentrations from the prospective ground water
r'fridfutpnng studies were used to estimate risk as a percentage of the RfD. Chronic drinking water
represented by adult males),
for the total US population is 40 percent of the RfD, for adult females chronic exposure is 48
percent of the RfD,' and for infants/children (the most highly exposed sub-population) chronic
exposure is 144 percent of''the RfIX gj^y" an(i dnnkmg; water exposures below 100 percent of
ijthg, RfD are generally considered not to be of concern. Chronic (non-cancer) risk estimates based
on exposurefe"I"j'S'-iD in drinking water are presented in table 9 below.
Risk estimates for drinking water associated with chronic, non-cancer effects were not
calculated for surface water because the available monitoring information on 1,3-D and its
degradates in surface water is inadequate (does not provide a long-term average concentration-
value, i.e., a time-weighted mean concentration or information on whether run-off would
contribute to surface water levels). No RfD was available for 1,2-D; therefore, a chronic drinking
water risk assessment was not performed.
kilkll |,| '"",, in;1 Iniii,!1!,
44
,! Jif,,.. , ' Si"1. !!'|j m.,;'!,, jlh.inriiiillii, i'1, ilil'Aj!!1 j,!!1 '.'.,,!! :ปi ,,ii| .,v" I1!1 ..''C i !||!',,:,!li:;ป' 111 'l'i|,ป'' I'J!
-------
Table 9- Risk Estimates for Chronic Effects (non-cancer) of 1,3-D and 1,3-D + Degradates as a
%RfD based on Maximum Exposure Calculated from the Wisconsin (up to day 337 from on-site
wells of 2- Year Study) and Florida Prospective Ground Water Study Data. ' v -
Wisconsin Prospective Ground Water Study (15-22 feet deep wells)
Populations
Adult males ,
Adult females
Infants & Children
Compound
Telone + degradates
Exposure (mg/kg/day)
1 x 1C'2
1.2 xlO-2
3.6 x 10-2
%RfD
40
48
144
Florida Prospective Ground Water Study (10 feet deep wells on site)
Populations
Adult males
Adult females
Infants & Children
Compound
Teloae + degradates
Exposure (mg/kg/day)
3.3 xlO-5 '
3.8 xlO-5
1.2x10""
Florida Prospective Ground Water Study (70 feet deep wells on site)
Adult males
Adult females
Infants & Children
Telone + degradates
4.9 xlO-6
5.6 x 10-6
1.7 xlO-*
%RฃD
<1.0
<1.0
<1.0
<1.0
<1.0
<1.0
(iv) Carcinogenic Risk from Drinking Water
The Agency estimated cancer risks associated with dietary exposure to 1,3-D via drinking
water from ground .water sources. Appropriate and reliable monitoring data for surface water
were not available. Cancer risks were estimated for the total US population only, because the
Agency has insufficient information to estimate lifetime drinking water consumption (or cancer
risk) for subpopulations of varying ages and reproductive status., "
Cancer risk estimates were calculated using the following equation:
Cancer risk = (chronic drinking water exposure, mg/kg/day) x Qx*, (mg/kg/day)"1
Chronic drinking water exposure values are derived from time-weighted mean
concentrations of 1,3-D, its degradates, and 1,2-D detected in the Wisconsin and Florida
prospective monitoring studies.
The praLQi* is 1.22 xlO'1 (mg/kg/day)-1 for 1,3-D and 3.69 x 10'2 (mg/kg/day)'1 for 1,2-D.
Note there is a separate Qj* for 1,3-D via the inhalation route of exposure, which is discussed in
the following section. .
-45
-------
In, '. "nil1'! I lii, .
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II. '!' ?'" 'f 'I
ill"! 'I Sl'.ii!' *:I*
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'i lii'i1',
I: I" J",,.llih;.!1
Cancer risk estimates were derived from both the Florida and the Wisconsin study based
on total concentration of 1,3-D and the degradates, 3-chioroailyl alcohol and 3-chloroacrylic acid
(assuming that the degradates have cancer potency equivalent to 1,3-D ). Lifetime cancer risk
estimates from wells located on-site are estimated to be from 4 x 10"6 (Florida) to 1.2 x 10"3
VI': |,li< , i;,i ..i':,,":!!1!,' " t1 !!!! i ",1ป\:l'lllll ' h,!,'i4,,, ...f, , *' Ml""1:,!! "' y"1', I'i'li,,, ' HUT!' ,:, - n< innm ,' , :'!. \v\\ ,ซ' , .'ปn,,,i,,':,i,, , ,,:>, i,: i'Hi,,,,i, " ป,' ,11 |V ! '
(Wisconsin). The new 1,3-D labels prohibit use within 100 feet of a drinking water well, so these
risks are likely overestimates.
Wj-itr:';:^/ '* ::; !;)ป- v.; '^- ;;^t;i l'1^^^--1'':^^,/^.^ ป,:.. Tf:? ' . ' ; ,.. : , , : :;
Both prospective ground water monitoring studies included limited monitoring in off-site
wells located down gradient from the treated fields. The studies were underway when the
registrant proposed the 100' no-treatment buffer from drinking water wells, and as such, the study
Copd not be modified to assess human exposures with this buffer In the Florida study, time
jjii'weigHted^ average (TWA) concentrations of 1,3-D plus its degradates in the on-site wells (101
deep) were 1.15 ppb. TWA concentrations of 1,3-D plus degradates measured in wells located
100 feet down gradient from the treated field were 0.074 ppb. In the Wisconsin study, on-site
wells yielded TWA concentrations of 1,3-D and its degradates of 357 ppb while concentrations in
a well 65' down gradient from the treated field were 26.6 ppb. Although neither of these studies
Jiwas designed to quantify offsite exposures, results in both studies indicate that exposures were
lower with increasing distance from treated field.
Dow AgroSciences has agreed as a condition of reregistration to conduct tap water
monitoring studies to better estimate current concentrations of 1,3-D and degradates in drinking
water. 'Sampling will be targeted to high-use areas and will be initiated once the new labels are in
^effect in August of 1999. EPA expects the sampling program will allow better characterization of
risks including the 100' setback required from drinking water wells now required on the-label.
Drinking water cancer risks were not calculated for surface water because the available
monitoring information on 1,3-D and/or its degradates in surface water is inadequate (since it
does not provide a long-term average concentration value, i.e., a time-weighted mean
w'&dncMtca^on) for use in a chronic exposure assessment tip estimate cancer risks. The Agency
||>el5eyes, it$|aj continued phronic exposure to 1,3-D is unlikely because 1,3-D is likely to dissipate
rapidly from surface water via volatilization, making chronic surface water exposure unlikely.
The potential for chronic exposure to the degradates is expected to be greater, since they are
likely to be less volatile than the parent. As mentioned in the previous section, Dow
AgroSciences is conducting a run-off study to investigate whether there is a potential for
tlllj ' (Tip! i: IIP', i, i I'll" , I ill ,1111m I, ,,,'H |. in , ", ,1 .iTr,, """. ,,lH|li!' 'l"l ,'H 'i "' i! ?>',,' ' III ir i: W',, II, ,'.ป!,' , H . ซ ,H,, ' '" I,,' ' "i" * ' I ' ,' , I1 . ', ' ' ' '
Substantial exposures via surface water. Drinking water cancer risk estimates based on ground
water data for the contaminant 1,2-D range from 6.3 x 10"8 to 1.8 x 10"6. Cancer risk estimates
for on-site drinking water wells are summarized in Table 10 below.
46
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Based on 1,3-D's chemical properties and pattern of use (i.e. soil injected^ exposure from
surface water is not expected to be significant. However, various models, as well as the results of
the Florida study showing detectable levels in nearby ditches, support the need for a run-off study.
Dow AgroSciences is also conducting other data on the environmental fate and ecotoxicity of the
degradates, together with the run-off study to confirm that surface water residues are not a
concern, or to provide data that allows EPA to characterize and address any potential concerns.
- ' '
The Agency notes that the models used to estimate surface water levels are not suitable
for tracking volatile soil fomigants through the environment; thus, EPA views the model results as
highly uncertain. See sections m.E. 1. and 2. for more details on these models and the water-
related studies assessing 1,3-D levels in the environment.
d. Occupational and Residential/Bystander Inhalation Risk
. ' . Characterization
Estimates of intermediate-term systemic risks and excess individual lifetime cancer risk for
custom operators, growers, and area residents/bystanders are given in Tables 11, 12, and 13.
(i) Risks from Intermediate Term Inhalation Exposure
For intermediate-term worker MOE' s, the 4-hour samples were used to calculate mean air
concentrations over all pooled replicates. Tables 11 and 12 present commercial "for-hire"
handlers and private handler (grower) exposure and risk estimates, respectively, derived using
these values.,
Table 11 presents the exposure and risk estimates for commercial handlers who handle
1,3-D, based upon the air concentration values listed in Table 7. Intermediate-term MOE's for
commercial handlers were calculated as the ratio of the intermediate-term inhalation NOEL to the
mean air concentration (adjusted by a 90 percent protection factor for wearing a respirator).
(ii) Cancer Risks from Lifetime Inhalation Exposure
Cancer risks for commercial "for-hire" handlers were calculated by first estimating average
daily doses (ADD's) in mg/kg/day, from the air concentrations. Information on days per year and
hours per day were obtained for each crop, state by state, from Dow AgroSciences1 Use and
Usage Summary Report. However, for loaders, the report lists only the total hours' per day spent
actually engaged in loading (0.5 to 1.25 hour/day), not total hours spent on site. Therefore, to
estimate their ADD's, the Agency therefore assumed loaders to be on site for the same number of
hours per day as the applicators (5 to 10 hour/day, depending on state and crop).
Table 12 presents exposure and risk estimates for growers who handle 1,3-D, based upon
the air concentration values listed in Table 7. For growers, the Agency assumed that the same
person conducts both loading and application of 1,3-D products. Since growers presumably
spend most of their work day engaged in application, rather than loading, intermediate-term risks
.;....' .;.-. 49 . ' - .
-------
ซ! Bill1 !'"|>:|IL i.i ,; ai;1",;; ilfj !f /n't;*!" :i;",Lli((.f")i. ;,':;, ,;, t,.' ',, i-",,!,:!- III.)'!!'! M in'rn: fiii,, . ,
^*i* te'irKtii iw1$ ^M^^mm^m^^ -:h
11,1* t,: ;'. -I1 ii:i;,;ii,i:;,: ,!! I,', "J : ">.'
(MOE' s) for growers were estimated using the air concentration for application rather than
loading.
Cancer risks for growers assumed that the majority of the work day is spent applying
1,3-D and only as much time as is required to load the tank is spent actually engaged in loading.
Therefore, the 4-hour samples were used in the calculation of the portion of the exposure .
1 |''"'"" "l|1 [ j'l" resulting from application, arid the task-specific samples were used to "calculate the exposure
incurred while loading (Because 4-hour samples were not collected for the mini-bulk study, the
Agency assumed that the task-specific loader air concentrations are experienced for the duration
of a work cycle). The loading and application exposures were then added, to estimate the total
exposure for these individuals.
(| Cancerrisk" estimates were calculated using me M^
Excess cancer risk = Qi* X LADE
!!" " III I I I II I I f ซ '.. r .' !' ' ' , "'
, T^ji ,|i i, ' I | J | '''.'' i "'i . V'
arid LADE = exposure (mg/kg/vr) X 20 ("custom) or 30 (grower) years
If':!1.',.'. ' '' '365 days/year 70 years
;^:::;Th;e,iexcess individual lifetime cancer, risk estimates; for occupational exposure range from
7.0 x 10"* to 6.1 x 10's for custom handlers and 5.1 x 10"^ to 5.0 x 10"* for private growers. These
yalues may be overestimates because they do not reflect certain mitigation measures which are
r'expec'ted to reduce risk, but can not be quantified. Generajly, the Agency considers risks of 10"6
or lower not to be of concern ami carefully examines nslcsin the range of 10"4 to 10"6 to seek ways
of reducing risks prior to reregistration (Barolo, 1996). Risks that fall closer to 10"4 where no '
additional mitigation is available are judged against the benefits of the pesticide?s use. For 1,3-D,
worker risks have been mitigated to extent feasible and are considered to be overestimates given
that Sppe |&^i|ieia$iffeง^;mjitisa.ti9n value cannot be quantified and included in the risk estimate.
In addition, thes Agency considers the benefits of 1,3-D use to be high. Based on EPA's policy,
the cancer risks of 1,3-D use for workers under current labels are considered to be acceptable.
in II i ' .:"'-iiL .:'./ ""ii,ii" niv t'i'ii ''I- ' .' '-11 / i. ;' ' , J
50
I itiia liii^ jd^ sm iiaii!^ iii'ii.a iiMa:ii.^^^ ti isii i uiti. i iiiiaii '.iiii
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Table 13 presents exposure estimates for residents who live near treated fields.
Table 13. Residential/Bystander Exposure
Distance
from
treated
field (m)
1600
1200
800
500
125
25
5
onsite
Study
Site(s)
AZ
AZ
overall
overall
overall
overall
overall
overall
Doses (mg/kg/day)
ADD
7.6 e-07
2.9e-05
5.7e-05
7.7e-05
4.8e-04
5.1e-04
8.3e-04
LADD
"
-3
-1
-2
-3
f,:Z\:"~
-2..
-2
-4
Cancer Int-Term
Risk MOE
1.7xlO'8
6.6x 10'7
1.3x lO'6
1.8x 10-6
"'-''- - 5,9.x ilp* '-
l.lx 10's
1.2x lO'5
1.9x 10'5
2800
1600
8500
6100
920
870
500
Shading denotes edge of buffer zone required 300 ft from an occupied structure.
'!ป , '" ", " ->ii > l ; i'iill ,,;;,'. " - i- , ;' i',,'" " tt, ,v" i t '". - 'f '.[ ;" > 1 !', -I- >., > ;v-v; ?;,'...,ป.,'ซ s. ,,: -, ".' ..
|iv'' ^IL; :';^li,;!;v!;^x.;:'^^.u<:^^:'t^:^ tv^'^^'-v^v. i:;f"^:;1-'ฅ:;'.. ^, .:, - .. -,.:
A buffer zqne> of 300 feet (approximately 125 meters) is required between all occupied
Structures and any field where 1,3-D is used to mitigate cancer risks to area residents whose
homes are adjacent to treated fields.
The resident/bystander cancer risks may represent overestimates because individuals are
not likely to spend 16 hours/day at a fixed distance for 30 years. Most people in regions where
1,3-D is used are not part of this subpopulation (i.e. do not live at the edge of a buffer zone), and
are therefore presumed to be at somewhat lower risk. Also, the population of area residents
living at the edge of the buffer zone is expected to be small, according to limited 1992 population
survey data from Dow AgrpSciences (Mehta 1994c). The population survey of states comprising
95 percent of 1,3-D usage showed that there were approximately 1088 residences in the 17 states
where 1,3-D is.usedi within one mile of 1,3-D treated fields (Mehta 1994c). there are no data on
the number qf people actually residing within 300 feet of treated fields.
" 1 IP i i i I iii ...:,". i i ;
I II I II ', ', , i ' > ' ' i,!'
i , .....
Other risk-mitigation measures, including reduced application rates, increased injection
depth, mandatory soil sealing, and soil moisture requirements may also reduce exposure to
residents and bystanders, although the magnitude of this reduction cannot be quantified and
therefore cancer risk estimates are likely to be overstated.
''"I1!.!"1
v'lk
52
-------
("0. Aggregate Exposure and Cumulative Risk
EPA has aggregated inhalation and oral exposures to 1,3-D. For 1,3-1), the aggregate risk
estimate would be calculated as follows:
cancer risk Cation exposure + cancer risk ^^ exposure = aggregate lifetime cancer risk
In calculating aggregate risk, EPA has determined that a reasonable worst-case exposure
scenario would be comprised of the inhalation risk at the 300 foot buffer, derived from the
average of three air monitoring studies, and water exposure risk from the on-site concentrations
from .the Florida study. EPA did not use the Wisconsin study values because as of
August 1, 1999, use in areas'similar to this site will be prohibited. Thus the aggregate risk
would be: ,
6 X lO'
+ 4 X lO
'6
waterexposurfe
= 1 x 10-s
This aggregate cancer risk estimate, however, is based on assessments which contain
numerous uncertainties from.both the inhalation and water routes of exposure. Those
uncertainties are detailed in section e. below.
Section 408(b)(2)(D)(v) of the Food Quality Protection Act requires that, when
considering whether to establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The Agency believes that "available
information" in this context might include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although the Agency has some
information in its files that may turn out to be helpful in eventually determining whether a
pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues concerning common
mechanism of toxicity in a meaningful way. EPA has begun a pilot process to study this issue ,
further through the examination of particular classes of pesticides. The Agency hopes that the
results of this pilot process will increase the Agency ' s scientific understanding of this question
such that EPA will be able to develop and apply scientific principles for better determining which
chemicals have a common mechanism of toxicity and evaluating the cumulative effects of such
chemicals. The Agency anticipates, however, that even as its understanding of the science of
common mechanisms increases, decisions on specific classes of chemicals will be heavily
dependent on chemical-specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the information in its files
concerning common mechanism issues to most risk assessments, there are pesticides fpr which the '
common mechanism issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which case the Agency can conclude
53
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that it is unlikgly that a pesticide shares a common mechanism of activity with other substances)
aiid pesticides that produce a common toxic metabolite (in which case common mechanism of
activity will be assumed).
EPA 4o,es not have, at this time., available data to determine whether 1,3-D has a common
mechanism of toxicity with 1,2-D or other substances or how to include this pesticide in a
cumulative risk assessment. For the purposes of this reregistration decision, EPA has assumed
that 1,3-D and 1,2-D do not have a common mechanism of toxicity.
e. Uncertainties in the Risk Assessment and Risk
I1,,, | (''(I | i Characterization Summary for 1,3-D
The Agency estimated cancer risk to growers, custom loaders/applicators, and
residents/bystanders exposed to 1,3-D. Exposures via the dermal route were assumed to be
negligible due to 1,3-D's high volatility and PPE requirements. Inhalation data were available and
deemed appropriate for quantitative risk assessment, and thus, route to route extrapolation was
not necessary for risk assessment. Oral and inhalation exposures were aggregated to develop risk
estimates for residentsftystanders. ,
There are numerous uncertainties associated with the studies used to develop exposure
estimates. Although the air monitoring studies were designed to evaluate exposures under normal
use conditions, the influence of local environmental conditions, such as wind, soil type and
weather patterns coupled with 1',3-D's volatility, resulted in mixed results. Results varied widely
not only between sites, but also within sites on a day-by-clay basis. The inhalation exposure
estimates provided in this assessment are derived from a limited number of monitoring studies per
site, which further increases the uncertainty.
Where possible, the Agency has incorporated label mitigation measures into the risk
assessment However, not all mitigation measures can be quantified!' For example, the following
mitigation measures are likely to further reduce worker and residential exposures to 1,3-D and
associated cancer risk: reduced maximum application rates by 30-65% depending on the crop,
increased soil injection depth from 10" to 12", soil sealing, and shank placement The actual
impact of these specific mitigation measures on reducing risk cannot be quantified with the
available data.
. ' ' "" ' .''''' ,' '. "i
Some air monitoring data need to be considered carefully, since the results did not show a
reduction in exposure levels with certain mitigation measures, including use of enclosed cabs and
dry disconnects measures which are known to reduce exposures. The monitoring data did not
show enclosed cabs to provide any reduction in exposure, possibly because applicators frequently
left the enclosed cab to perform various tasks during the application process. Therefore, the
1,3-D labels were modified to require a respirator if the worker leaves the enclosed cab during
application for any reason.
54
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Dry disconnects, which are couplers designed to prevent leaks and emissions during
fumigant transfers, appear to offer some exposure mitigation. Exposure reduction with dry
disconnects could be quantified with the short-term sampling data but not with the 4-hour
sampling data. The 4-hour sampling data suggest an increase in exposure with the use of dry
disconnects, which is counter-intuitive. The reasons 'are likely due to a low number of sampling
replicates and inherent variability in the study conditions. . - '
. , y f - . ,
There are uncertainties regarding practices of commercial operators. Exposure and risk
estimates provided assume that commercial operators treat only one crop. Risk may be
underestimated for commercial operators treating specialty crops in. the Pacific Northwest:
However, the Agency also believes that custom operators are in a better position to train
personnel and maintain and update equipment, which results in better control over exposures to
1,3-D. ; . . . ' '' . . '
Some use practices have changed since the early studies were conducted, as have the laws
governing agriculture. Just as local environmental conditions affect 1,3-D volatilization,
individual growers' decisions on application rate, application method, injection depth, and soil
sealing measures vary. For example, some growers use different application rates from year to
year depending on the level of nematode infestation. Actual land use is unpredictable,'and is
ultimately driven by weather conditions, pests, and market pressures. Therefore, the inhalation
exposure estimates and assumptions used represent a simplification of real world exposures
J The residential risk assessment is based on an average for the three sites monitored (N.C.,
WA, AZ), though 1,3-D air levels were quite different among the three sites. In addition/the
monitoring at the N.C. site was conducted using drum loading, which was the predominant use at
the time of the study, but which has since been phased out in favor of mini-bulk containers. Air
: levels with drum loading are expected to be higher than the mini-bulk containers since closed
loading and dry disconnects (to prevent release of vapors) were not used with drums and since
loading 1,3-D into the tractor-drawn tank was more frequent because the 55-gallon drums were
smaller than the 1000 gallon mini-bulk. A mini-bulk study was submitted in 1996, but Was only
designed to measure worker exposures. Although higher levels were seen at the AZ and WA
sites, EPA expects that the levels from the N.C. site, and thus the average overall, would have
been lower had the mini-bulk system been used in the off-site monitoring.
- For the water exposure component of the aggregate risk estimate, levels monitored from
on-site wells were used in the assessment. As of August 1, 1999, however, there will be a 100
foot no-treatment buffer between treated fields and drinking water wells. The prospective ground
water monitoring studies included limited off-site monitoring, which showed decreasing levels
with increasing distance from 1,3-D treated fields. However, studies with more sampling and a
study design to look specifically at levels in off-site wells would have to be conducted in order to
quantify any relationship between distance to treated field and levels in wells used for drinking
water. - . . " ,
55
-------
i i mi
, ........ ,. ,,
i - Mii!,!!"'".!,: ..... :,!! K,"
j>]l }. llti;'
11 y^li'riip
I ii/lli^i''''^1111!
11, is, "i ii!!;,, ,
I'Hii IMC '
1
iSlilri'iiirii!'!1 'jmiii .
;.i lie!,],;!1! i, 1( li'i; !
'
Despite the limitations discussed in this section, EPA believes that the air and ground
water monitoring are suitable for risk assessment. The studies were specifically designed to assess
exposures to 1,3-D, taking into account the unique chemical qualities of 1,3-D, as well as the
specialized 1,3-D loading and application techniques. However, the influence of a variety of
environmental factors, particularly in the air monitoring studies, confounded many results. Even if
additional data were required to address some of the shortcomings discussed above, EPA believes
it would be unlikely that the additional effort: wouldsignificantly improve the assessment given
that confounding factors, such as wind and precipitation, could not be controlled under actual
field test conditions.
,
,|!jiป;j4'
1. Environmental Fate and Transport
I I"1 : ' , ' ,/ ;... . ' " ! ,
,;,i:ll,3 -D dissipates primarily through volatilization, leaching, abiotic hydrolysis, and aerobic
;,, ..... and Acre is an increase in Stability at lower temperatures. At 2ฐC, for both pH 5 . 5 and 7.5, the
v':-': ll^lljIfviPli^iE!!1;6?* w^ ^> to ........ iฐ9 days. Vndtt&e^i?. wnditions, half-lives ranging from 12. to
* :. lill^1 ?re /Sorted for *ฎ P^ent ^e 3-^oroallyI ..... alcohol ...... is'expected to be the main
hydrolytic degradation product and 3-chloroacrylic acid the major aerobic metabolite. Laboratory
Mobility data, in addition to ground-water monitoring information., has clearly demonstrated that
Tj3-D is i highly mobile m soil The Frg^lich adsorption coefficients for 1,3-D were: Kd=0.23 in
loamy sand, I^== 0.32 in sand; and in clay, Kd= 0.42 and 1.09.
aJ Environmental Fate Assessment of 1,2-D
........ _..
......
mm I >,ป$'!':;
| iMi'iillii^t'ip'1-: '
A til W"?1 (I"1*!; ii1.1' '"
, , , , , , .,,, , , , , , , , , , , ,
::::: I :.f'' :;%e_fonnulated 1,3-D product contains ^frpm 0. 1 to 0.06 percent 1,2-D. 1,2-D has a
^ajpbrp^1sureo?42mmHg'at20i'C, has a water solubility ''of :2700ppmat 20ฐC, is fairly stable
j]^,งydJ?lysis with a half:life of 77 days at pH 5.5, ^and has variable aerobic soil half-lives (41 to, 69
Jays on four soils but stable in a sandy loam and a loam). With 1,2-D, photoreactions are also
jjmmmal^with ..... ahalf-life ..... of 3 1,3 i days^ with ..... resgect to theiiii(OH)iiradicali and .stable, with respect to '
IgjF?^- ...MRfeM^8^6?' &Yฎ ,a ^o^'^^tion' of the extreme mobility of 1,2-D. Freundlich
Si W^ฐ"f ฐ^^'^^^^ Kd=0.87 for the Fuquay
jp^y ,,^dป-Meง s^%, loain, Hanfordloam,^ and the Wahiawa sandy clay loam soils,
l^specfively. Iii column leaching experiments using a Fuquay loamy sand with 0.64% organic
earbon, a total of 85.8% of the applied 1,2 -D leached from the soil column. For the Wahiawa
sandy clay loam column with 2.32% organic carbon, a total of 73 .2% of the applied was found in
theleachate. Thus, mobility was somewhat inversely proportional to organic matter content.
b. Degradation
iiihi'i ' ir ,i>. i ' i ' ','
Hydrolysis. In buffered solutions at pH values of 5, 7,9, the half-life of 1,3-D was 13.5
days at 20ฐC. Arsupplemental study at pH's 5.5 and 7.5 showed that the half-life of 1,3-0 was 90
II II
56
,i [ii i- '! ' .,.-.'..: ill
-------
to 100 days at2ฐC;'ll to 13 days at 15ฐC; and 2 days at29ฐC. The chloroallyl alcohol is expected
to be the main hydrolytic product (MRID 00158442). ,
\ . . ,
Another supplemental study gave these results: at pH values of 5, 7, and 9, the half-life of
1,2-D was 51 days at 10ฐC; 10 to 13 days at 20ฐC; and 3 to 5 days at 30ฐC. The chloroallyl
alcohol reached maximum concentrations of 32%, 72%, and 78% at 10ฐ, 20ฐ, and 30ฐC,
respectively, and appeared to be stable to further hydrolysis. Hydrolysis of 1,3-D is pH
independent and temperature dependent (MRID 00117050).
Photodegradation in Air. Both cis and trans 1,3-D (purity > 94.8%) at 0.035 to 0.050
Mg/ml did not degrade in borosilicate glass vials irradiated continuously for 30 days with a xenon
.arc lamp at 25ฐC and ambient humidity. After 30 days of irradiation, 95% to 98% of the applied
radioactivity was recovered, as 1,3-D and no degradates were detected. In the dark control at 30
days post-treatment, 86% to 92% of the applied was recovered as 1,3-D and no degradates were
observed. The study indicates that under these conditions, direct photolysis in air is not an
important degradative mode for 1,3TD (MRID 40390101).
Reactions of 1,3-D and 1,2-D with ozone (O3) and OH radicals were studied. The half-
lives of 1,3-D with respect to the OH radical were seven and 12 hours for the trans and cis
isomers, respectively. The observed degradation products were formyl chloride and
chloroacetaldehyde. The half-lives of the trans and cis isomers of 1,3-D with respect to ozone
were 12 and 52 days, respectively. The observed products were formyl chloride and
chloroacetaldehyde, chloroacetic acid, HCL, CO, CO2 and formic aci.d. The rate of photolysis
alone seems insignificant (as was shown in the above 161-4.experiment) relative to the reactions
of 1,3-D with ozone and the OH radicals. For 1,2-D the experiments also indicated that the only
significant loss in the atmosphere would be a reaction with the OH radical. The half-life with
respect to the OH radical was 313 days. A half-life of 313 days for 1,2-D would indicate the
compound is sufficiently stable for worldwide long-distance transport (Tuazon, 1984).
Aerobic Soil Metabolism. The reported half-lives were 12 days in Catiin silt loam soil
and 54 days in Fuquay loamy sand soil. These major nonvolatile degradates were isolated from
the soils: cis/trans-3-chloroprop-2-en-l-ol (3-chloroallyl alcohol) and cis/trans-3-chloroprop-2-
enoic acid (3-chloroacrylic acid). Numerous naturally-occurring carboxylic acids were also
identified as degradates (MRED 42642301). "
i
Anaerobic Soil Metabolism. In a silty clay loam soil at 15ฐC, the half-life of 1,3-D was
reported to be 9.1 days. In a sandy loam soil at 15ฐC, the half-life was 7.7 days. In both a silty
clay loam and sandy loam soil, at 25ฐC, the half-life was 2.4 days. The observed degradates were
chloroacrylic acid, propionic acid, and an unknown (MRID 40025901)
c. Mobility
Column Leaching. The calculated Freundlich adsorption coefficients for 1,3-D were:
loamy sand Kd= 0.23; sand Kd= 0.32; clay Kd= 0.42 and 1.09, The average maximum K00 values
57 .
-------
r
'*' ill! IJ
lit 3:
IS
'!,;>'!::,*;[>!
tit "i"
"B, 1
were 20 for sand, 25 for loamy sand, and 41 and 42 for two clay soils. In 30-cm columns of sand,
loamy sand, and Horida clay, 1:34D leach^ \^en more lhan 25 inches of water were applied. A
total of 1.9% to 4.6% of the applied (unaged) radioactivity remained in the soils and 70% to 84%
was found in the leachate (MRID 4053 8901).
Aged Column Leaching. Aged (31 days) 1,3-D residues were very mobile, with 25.6% .
to 32.0% of the applied radioactivity in the leachates of 30-cm columns of loamy sand soil. 1,3-D
and the degradates 3-chloroallyl alcohol, chloroacrylic acid, and composite carboxylic acids
(including acetic acid, oxalic acid, and propionic acid) were detected in both the leachates and the
soil segment extracts.
Batch Equilibrium (1,2-D). Freundlich adsorption coefficients for 1,2-D were 0.12
(n=1.13), 0.16 (n=1.13), 0.05 (n=1.63), and 0.87 (n=1.07), with corresponding Koc,s of 18.8,
23.5,10.4,37.5 for the Fuquay loamy sand, Metz sandy loam, Hanford loam, and the Wahiawa
sandy clay Ioam2 respectively. The Freundlich desprption coefficients were 1.54 (n=0.99), 0.93
^1=1.22), 6.45 (n=i.52), and 3.45 ^=L13X with corresponding Koc's of 241, 137, 93.8 and 149
for the Fuquay loamy sand, Metz sandy loam, Hanford loam, and Wahiawa sandy clay loam
:' " ''T^42|685j)i)., \ ''
i, ' I!1" |, ,,im; 5i, mill' I I ,;, ' "ฅ :
'(' ",'[,,1 , 'I'll., "[ i-iifjit 11 i I " .>.....:.
'^CoIumEjLeaching (1,2-D). The column leaching experiments indicated that for the
tf'i "i
Hi:;
, ,;|i ...... i
Fuquay joa^ the soil column. 1,2-D
'
tedyejfjy^ iroughout the column. For the : Wahiawa sandy clay loam commn, a total
c^tiie appHed wasfbund in the leachate. 1,2-D was not evenly distributed throughout
nis were highest near the final soil segment. Sorption coefficients
estimated from the column leaching studies were 0.09 and 0.43 for the Fuquay and Wahiawa soils
with corresponding Koc's of 14. 1 and 18.5 (MRID 42868501).
Field Volatility. The factors influencing the volatility of 1,3-D from a field plot include,
b,wt are not limited to, soil organic matter, wind speed, soil moisture content, depth of
incorporation-injection, soil temperature and soil porosity. Approximately 25 percent of the
applied 1,3-D had volatilized by 14 days post-treatment (the final sampling interval). The
volatilization of 1,3-D increased to 35,1 mg/m2-hour by 3 days post-treatment using the
aerodynamic flux method with 33- and 90-cm sampling levels at the plot center. Volatilization
ranged from 8.13 to 22.3 mg/m2-hour at 4-6 days, 4.6 to 17.5 mg/m2-hour at 7-9 days, 3.31 to
7.78 mg/m2-hour at 10-12 days, and 1.28 to 4.93 mg/m2-hour at 12-14 days (MRID 42545101).
1,3-D was soil injected at 12-14 inches at 346 Ib. a.i. per acre into fields of sandy loam,
loamy sand, and muck soils. At six to 12 hours post-treatment, 1,3-D reached a maximum
concentration of 0.09 to 4.4 ppm at the 6.5-foot height above the soil surface. 1,3-D
concentrations decreased to < 0.03 ppm in all air samples from all locations by seven days post-
treatment It was not detected above the loamy sand and sandy loam soils by 14 days or above
the muck soil by 21 days. Volatilization rates appeared to be inversely proportional to the amount
of soil organic matter and proportional to soil porosity (MRID 41057701).
I II'!
!, , iii",,:,! ,
i "i1 :?.
58
1 in
-------
Telone H was applied at approximately 12.8 gallons per acre (121 Ibs al/acre) to a fallow
plot in Nevada and monitored over 7 days for airborne concentrations directly above the field and
at locations up to one-half mile away (no MRID, EFGW& #91-0910). The average value of
1,3-D at a 6-inch height above the field during 7 days was 465.31 ug/m3; at a 5-foot height at the
edge of the field it was 94.81 ug/m3; at a 5-foot height 100 feet from the field-it was 39.39 ug/m3;
at a 5-foot height 1/4 mile from the field it was 5.17 ug/m3; and at a 5-foot height one-half mile
from the field it was 3.88 ug/m3. Wind was a major factor in the dispersion of 1,3-D as higher
concentrations were measured at night. During the day,' the increase in wind velocity also
increased vapor dispersion and lowered the measurable amount of material (Houtman et al
1991). ,
In general, it is difficult to correlate soil moisture content with volatilization but Glorfelty
and Schomberg (1989) and Lyman et al. (1982) suggest that the extreme drying of soil during
drought will greatly decrease volatilization. Addition of moisture to dry soils will generally
increase volatilization rates to a point beyond which additional moisture may have little effect or
may start to decrease volatilization. The effect of changes in soil moisture on the volatilization of
organics from soils with intermediate moisture contents is difficult to predict and depends upon
the chemical, soil type, and the initial soil moisture content. In general, soil chisel incorporation
of 1,3-D is accompanied by capping off the soil injection cores and/or by covering the field with
plastic to minimize volatilization. Deeper injection minimizes the total amount of material that .
volatilizes and maximizes the amount of time from injection until volatiles are observed at the
soil/air interface because of the increased soil distance through which the pesticide must diffuse.
d. Field Dissipation
Terrestrial Field Dissipation. Gis and trans 1,3-D applied at 345 Ib a.i./A dissipated with
an observed initial half-life of approximately one day and a second half-life of approximately seven
days in the surface 24-inches of a bare-ground loamy sand soil (MRID 40855501).
1,3-D was applied at 342 Ib a.i./A to a sand soil field plot in California. 1,3-D.residues
declined from a maximum of 130,000 ppb in the 0.3- to 0.45-meter layer of soil immediately after
treatment to less than 10 ppb (detection limit) in any soil layer at 71 days. The degradate 3 -
chloroallyl alcohol declined from a maximum of 410 ppb in the 0.66 to 0.81 meter layer of soil at
seven days posttreatment to less than 10 ppb in any soil layer at 71 days (MRID 40403 3 01);
additional data 3/24/89). The half-life is approximately seven days assuming a linear dissipation
rate. . ,
2.
Water Resources
a.
Ground Water
High-quality data indicate that 1,3-D leaches .to ground water as a result of normal
agricultural use. The 1986 Registration Standard and Special Review position document both
59
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(Hi) State Ground-Water Monitoring Studies
The Pesticides in Ground Water Database (EPA, 1992) indicates detections of 1,3-D in
three states -- Florida, New York, and Washington ~ because of normal field use. The database
also reports detections of 1,3-D in California because of point source problems (i.e., misuse or a
spill). Additional monitoring in Hawaii, Massachusetts, Mississippi, and Oregon has not yielded
any detections of 1,3-D. . /
California. In 1987, 1988, and 1991, 1,3-D was detected in six wells in Del Norte, Fresno, and
Santa Clara counties. Using a method detection limit of 0.5 ppb, concentrations ranged from 0.89
to 1.9 ppb. No information is available about the source of the detections. 1,3-D was not
detected in 9,915 wells sampled from May 1979 to June 1996 using detection limits ranging from
0.02 to 100 ppb (Bartkowiak, 1997).
In Riverside, California, illegal use of 1,3-D in 1986 and 1987 resulted in six detections in one
irrigation well ranging from 6.8 to 31 ppb (EPA, 1992).
Florida. From 1987 to 1996, a total of 9,505 wells were monitored for 1,3-D residues.' The
present detection limit is 0.085'0 ppb, but has varied in the past (Fisher, 199,7). Although 1,3-D
was detected in three wells at concentrations ranging from 0.28 to 8 ppb, these are probably most
likely 1,2-D detections (Riotte, 1997).
Hawaii. The Hawaii Department of Health monitors for 1,3-D in.ground water because of its use
as a soil fumigant in the pineapple industry. From 1979 to 1987, samples were analyzed from 54
wells and no residues were found (Giambelluqaj 1988);
Massachusetts. In the summer and fall of 1985, several Massachusetts agencies analyzed
samples from 239 wells in tobacco-growing areas. Using a detection limit of 1.0 ppb, no 1,3-D
was found. No samples were analyzed for degradates (Massachusetts Interagency Task Force
1986)., -'.' '
Mississippi. In Mississippi, a statewide drinking-water ambient monitoring survey was designed
to sample for pesticides. 1,3-D is not widely used in Mississippi (Landreth, 1997), and the
reported monitoring may not have been conducted in area's where 1,3-D has been used. To date,
348 deep wells have been sampled and analyzed for cis and trans 1,3-D. No residues have been '
detected using a detection limit of 0.10 ppb for the parent.
New York. Although monitoring for 1,3-D is not usually done by the State, several studies have
been done by researchers to determine the leaching potential of 1,3-D in Suffolk County, New
York. In one of the studies done iri 1983, 1,3-D was detected in ground water at concentrations
ranging from 37 to 270 ppb in one well over a period of three months. The detection limit used in
this study was 2 ppb (Loria et al., 1986). In another study, no 1,3-D was detected in nine wells
located near fields where 1,3-D was applied. The detection limit used here was also two ppb
(Kotcon and Loria, 1987).
61
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'ill I
ill 'lil
f IN
11-JI
1 !'"' LSI
, I" !.,' 111'"', I
ij 'if
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Hi1'Tlill' ' in "i
Qregon. In Oregon, a standard analytical screen that includes 1,3-D is performed for every well
that is sampled. Many of these wells are not in agricultural areas or 1,3-D use areas. Some 1,3-D
has been found using a detection limit of 0.5 ppb. However, problems with data retrieval make it
iniposSible to determine how much or how many times 1,3-D has been detected (McLaughlin,
iSj I'iili ili \ ^p .I,,T < , 'ซ, .1 , H,,,, i,. , 11*11,,,, ," , ซ:,. n,' ,
jington. From 1990 through 1996, the Washington State Department of Ecology analyzed
! wells for cis and trans i,3-D. The trans isomer was found on April 30, 1991 in three wells at
concentrations of 0.10, 0.11, and 0.11 ppb. The same three wells were re-sampled in February
1992 (10 months later) and no 1,3-D was detected (Larsen, 1997).
(iv) Small-Scale Prospective Monitoring
Wisconsin. The Agency required that Dow AgroSciences conduct a small-scale
"prospective ground-water monitoring study in a northern climate because of the concern for
|;|ji:i^ป:ฃj2''";:'"';,ซ'Nebraska, Wyoming, Michigan, Minnesota, ^Oj^ Dakota and Wisconsin. The site selection
criteria required shallow ground water, porous soils, minimal slope, no impeding layer (such as a
ni?TIWFI,S:l IS'III "'I HIM I I III J*1 ป ฐ^ '~ ' ' r ' . T .,. ฐ , J .. ^
clay barrier) between the treatment zone and ground water, no prior usage of 1,3-D and no
concurrent usage of 1,3-D in the vicinity of the test site. Potato-growing areas in these states
were targeted since potatoes are a major use site for 1,3-D use. The site in Wisconsin met all of
EPAand Dow AgroScience's selection criteria and was thus.selected to represent a vulnerable
, iilSil , ii;i, ,...., s,i|eiji aQojflie,rnuse area.
;{jOfl, September 9,1997, Telone n was applied to a sugar beet field at 28 gallons per acre
lbs ai/aare). Levels peaked at 579 ppb in pn-site wells after one year of monitoring. In the
well located 65 feet down gradient, 1,3-D levels peaked at 173 ppb.
1,2-D was detected in all eight of the pnsite shallow wells and four of the onsite deep
rcpni^^r^ons^anj^n^from trace levels to 3.9 ppb using a quantitation limit of 0.05 ppb.
-------
detections of 1,3-D, 1,2-D and both the 3-chloroacrylic acid and 3-chloroallyl alcohol degradates
in ground water.
Most Floridian soils are porous with shallow water tables. While most residents of the
state obtain water from public systems which tap aquifers that are not surficial, there are areas
where 20% or more of the residents obtain water from private wells that tap surficial aquifers (in
some counties up to 80%). Some areas have a spodic horizon between the surficial and deeper
aquifers, while other areas overlay karst geology (highly permeable, rocky soils). Note that as of
August 1, 1999, the 1,3-D labels prohibit use in areas of karst geology. In order to support
agriculture in certain areas of Florida, perimeter ditches are used to either raise the availability of
water serving the field, or to divert excess rainfall. There can be extensive interaction between
these ditches, surface water and surficial ground water aquifers. Because of the warmer
temperatures, EPA expected the rate of degradation to be relatively higher than in areas with
lower temperatures.
In the uppermost part of the aquifer (one to two foot wells which were not used in the'
, drinking water assessment) 1,3-D was detected in all eight of the onsite wells. Detections peaked
at 833 ppb and declined to 0.19 ppb by 110 days after application. These wells also contained 3-
chloroallyl alcohol at concentrations ranging from trace levels to 360 ppb and 3-chloroacrylic acid
at concentrations ranging from trace levels to 424 ppb. 1,2-D was detected at concentrations
ranging from trace levels to 11.5 ppb. Five offsite wells also contained 1,3-D residues at
concentrations ranging from trace levels to 0.23 ppb.
At a depth of 10 feet from the surface, 1,3-D was detected in all eight of the onsite wells.
Concentrations ranged from trace levels (0,05 ppb) to 21.6 ppb. These wells also contained 3-
chloroallyl alcohol at concentrations ranging from trace levels to 13.5 ppb and 3-chloroacrylic
acid at concentrations ranging from trace.levels to 8.79 ppb. 1,2-D was detected at
concentrations ranging from trace levels to 1.28 ppb.
Early in the study, 1,3-D was briefly detected in the deep part of the aquifer (70 feet),
however, the concurrent water blanks from the bailers used to sample the deep wells contained
similar 1,3-D concentrations. Also, the bromide tracer did not reach these deep wells during the
study, suggesting these detections were the result of inadvertent sample contamination. However,
the information submitted is as follows: 1,3-D was detected in two of the three onsite wells in the
Lower Tamiami Aquifer with concentrations ranging from Q.05 to 1.03 ppb. These wells also
contained 3-chloroallyl alcohol at concentrations ranging from trace levels to 7.85 ppb and
chloroacrylic acid at trace concentrations. 1,2-D was detected at concentrations ranging from
trace levels to 0.07 ppb. No 1,3-D residues were found in the offsite deep well; 1,2-D was
detected in this well at trace levels in all but one sampling event '
(v) The National W*ater Quality Assessment Program
In 1991, the U.S. Geological Survey initiated the National Water Quality Assessment
program (NAWQA) to study national water quality: The monitoring, which is being conducted in
63
-------
I!1!-' Jt :ซ*".
I 'jurat:, ;iป'!'
ill IM!J iil;IM* li'l FU:
ni!",i, ; >ปป:'
III''!' I!':,;
I i'"1"""1
j 1"!:
t
[I illii "i i; f!
I I '!|
I i,;,'il,t
I <:''!ili:fli,
IfcW
MI: M. virii, ,,.1
','W ซK I:.:1?
mm r^t-r;
^'^^
-A^i^'viMfc'';;;:^^
jfbur parts, will assess more than 50 of the largest river basins and aquifers (study units) and cover
the; drinking water sources of about 70 percent of the U.S. population.
'|','!|,ii!l!i,! ' ;' !"J" '
-------
Concentrations in the water column will be less than in the sediment pore water, but should still
be somewhat comparable to concentrations adsorbed to sediment. The low octanol/water
partitioning of 1,3-D indicates that its bloaccumulation potential is probably low.
c. Drinking Water Exposure Assessment
Please refer back to section DDE. B.3. for a full discussion of the levels used'for the drinking
water exposure and risk assessment. <
3. Ecological Assessment
a. Toxicify to Terrestrial Animals
(i) Birds, Acute and Subacute
An acute oral (LD50) study using the technical grade of the active ingredient (TGAI) were
submitted to establish the toxicity of 1,3-D to birds. The result of the Northern bobwhite test is
presented in Table 14.
table 14. Avian Acute Oral Toxicity
Species
Northern bobwhite
(Colinus virginiamts)
%ai LD50(mg/kg) Toxicity Category
92 152 moderately toxic
MRIDNo.
00118938
Wildlife
International
/1982
' .Study
Core
1 Core (study'satisfies guideline). Supplemental (study is scientifically sound,,but does not satisfy guideline)
Since the LD50 falls in the range of 51 to 500 mg/kg, 1,3-D is moderately toxic
to avian species on an acute oral basis (MRID 00118938). '
Two subacute dietary studies on the Mallard duck and Northern bobwhite using the TGAI
were submitted to establish the toxicity of 1,3-D to birds. The avian acute dietary LCSO test is a'
subacute, eight-day dietary laboratory study designed to determine the dietary concentration of
toxicant that is likely to cause 50 percent mortality in a test population of birds. The TGAI is
administered to juvenile birds' diets for five days, followed by three days of "clean" diet. Results
of these tests are presented in Table 15.'
65
-------
'"" JBTffปT!trP: Ill V : FT1! "Si'' lllllli'. I''"!' I W, M|Iป, : "';>!'! t.v iihiil ; ป"
i :=! -ft: 'iiVS:
I i'id |i" ,:;;;! .iijllli ' ;TI
I 'I-
.-' . ':, iilllllt i ,' ,' : -"ID
i-i,i:ll' IPiilll''1' I." ;" r" .
iiC'ir.tij :UEI: ,",:
!'!,!"' "I11 'iilniniiiillilll' ^ IB
i:!'111! I I.' Ilill'l, !,l!'l|l|l' V Tlililll!" I I1 "
ill,1 I-"')*,!':;':" ii1;!!;, "i: .""
;::"!'ป
/;!!*!'
mi! "I'1"!1!,!!1: / 'ป, "'!|!.!
''',,1,1,'I li/l'l.i, I'll1'1 '! I,"" " * I 1 '
lit.,1E|bie|S Avian^MJSStfS.P'gfcyyToxicity
Ilii !;!!?"'! IS.!"*"!'1
"I'lillllhi niii'1 i'T. i.1 'iilln Tilill' i iv
*)* Species
: ii1'1! fif iilKii!; fc-iiiiiii; - h;!:!
-:;;j ''': "'' "'-'
Toxicity Category
MREDNo.
AuthorATear
Study
Classification
Nwthenibobwhite 92 >10,000 Practically STEODIQ3 Core
'..iHr.r. :: ' ;;:' (Colinusvirginianus) Nontoxic ' Fink, 1975
"i'f-I*'1.'1': , ii"! i" MarJ'&ieic " 92 " >iO,000 ""'Piacficaiiy " "' 00120908 Core'
< i i='';i':i;:i,. i r , ., jjjiij" (Aitaspldtyrhynchos) Nontoxic Fink, 1975
III ป,'", i.iiiiiiiiiii", :i " ,'in jiiii ,'" iniiiiipiiliii1 ...in "^^^^^""""'""^"^^""""""""""""T" ""1^^^^^" """""""T"^""^^^^"^^"^^^T1^!,
is fjffi^Wk T": iivi "i i iiniiii i 11 i ii ': . I. ."I,1'.-''-''
ii: 'Hi', nil. '""Illlilllir1 , ll'l1",,, , '. fllKijIl' :,;,!, I II I I I II 111 ' I' ' ' ,' , ' ,
,UThe LC50 is higher than 2,000 ppm. This toxitity vahie indicates that 1,3-D is practically
|! "til I. 'iilillHS lilil ill!' , I ; III i'Jl'S'l'i! I,: ill- I'-'' ป ' t.l. =f 'ซ . ซft^.. -i , ' r,f. -,..; A...; [;,.,. . .f : , . *
nontcwac to birds on a subacute dietary basis; however, this result is inconsistent with the acute
-Oitii test. The subacute dietary results could be explained by the fact that the length of time to
perform the test is long and, because 1,3-D is highly volatile, it may not remain in the food.
^TJnerefere^ the birds may have received an inadequate dose resulting in a low dose response. Field
|i|ritซfii!;|* "r! , SfSludy 3ata indicate that volatility is the primary route of 1,3^D dissipation with dispersal
I ill I I'"1 PI /V I'l'''''11'11'''''- " '"-ซป:.-. .' -'. "1 tป) ' '- ' ' " * ' !
incTeaSliflg to 35.1 mg/m^/hour by three days. Therefore, the weight of evidence indicates that
1,3-D is moderately toxic to birds (LD^ = 157 mg/kg) (MRID's STEODI03 and 00120908).
ปi7-!\ .:'-i i ./,';.,..., (ii) Birds, Chronic
.yian reproduction studies using the TGAI were not required for 1,3-D in the 1986
Standard. Since the field dissipation half-life is roughly one week and generally only
..,ma^e,Per,,ye,aJป ^f^?..^T? ^ot exPecte4 *ฐ ^e exPose(^to rePeated or continuous
residues of 1,3-D. . ' ,i
(iii) Mammals, Acute and Chronic
;'-if "'..'v'V'" i " i ' ' ' ' "'" ' - ';;: ' '""''!
The toxicity values for mammals are presented in Table 16 (USEPA, 1997). Results
indicate that 1,3-D is slightly toxic to toxic to small mammals on an acute oral basis (640 mg/kg)
:.,-, "':"; , ,:, ' (MOD #0039693). ' \-
i r jniiiiiirL1'!'1'r;,! Vi ' I'ljji1.1 :' v' . , "h, ',,111 * I "''"' "I1'1
.HI, 'i| 'i":i LIIHT:
66
-------
Table 16. Mammalian Toxicity
Species
Laboratory mouse
(Mus musculus)
Laboratory rat
(Rattus norvegicus)
1 Laboratory mouse
(Rattus norvegicus)
Laboratory rat
(Rattus norvegicus)
Test
Material
Telone II
1,3-dichlpropropene
1,3-diohlorpropene
90% ai
cis+trans
Test
Type
Acute Oral
Acute Inhalation
Chronic Inhalation
Developmental -
Inhalation
,
Toxicity
Value-
LD50.
640mg/kg(M&F)
LCM
729 pp'm/4 hours
NOEL Systemic
730 ppm
NOEL Maternal
20 ppm
NOEL Developmental
60 ppm [
Affected
Mortality
" Mortality
. No systemic effects
observed at 730 pprh
Maternal- body .weight
loss and reduced food
consumption , .
Developmental - delayed
ossification of vertebral
centra
MRIDNo.
00039683
235350
00039685
00144715
00152848
Laboratory rat
(Rattus norvegicus)
96% ai
cis+trans
13 Week Feeding NOEL 5 mg/kg/day
LOEL15 mg/kg/day
i
;Bฐdy weight,
hyperkeratosis and/or
, basal cell hyperplasia of
the non-glandular portion
42954802
(iv) Insects
A honeybee acute contact study using the typical end-use product was not required in the
1986 Registration Standard. The registered application method via soil injection prior to planting
should not result in honeybee exposure. However, exposure in adjacent habitats could occur
because of 1,3-D's volatility and the probability of the chemical drifting offsite.
Results from a study submitted for contact toxicity on honeybees are presented in Table
17, and indicate that 1,3-D is moderately toxic to bees on an acute contact basis (MRID's
00028772 and 00018842). . ;.
Table 17. Non-target Insect Acute Contact Toxicity
Species
Honey bee
(Apis mellifera)
Honeybee
(Apis mellifera)
LD50 .
'TGAI e.e
Formulation 6.6
Toxicity Category
Moderately toxic
Moderately toxic
MEIDNo.
Author/Year
00028772/
Atkins/1972
00018842/
Atkins/1969
Study
Classification
Core
Core
b. Terrestrial Field Testing
Based on the application method and use pattern, terrestrial field testing of 1,3-D has not
beeri requested or submitted to support reregistration.
67
-------
_ I ' '
Toxicity to Freshwater Aquatic Animals
\ " ' !
(i) Freshwater Fish and Amphibians, Acute
III1:,;1";!;, ปi ji'iliini'1',11111;,,
IB'!1, 'i',!!!1!,
Freshwater fish toxicity studies using the TGAI were submitted to establish the toxicity of
1,3-D to fish and amphibians. Results of these tests are presented in Table 18. Since the LC5Q
J^Is in me range of 1 to 10 ppm, 1,3-D is moderately toxic to freshwater fish on an acute basis.
(MRWs 00039692 and g^oj-)^ ^ registrant: is ^ conducting additional studies on the
degradates as confirmatory data.
Wljlj ';' ' i,
Ilili,,1' I I 111
;;. fible IS. Freshwater Fish Acute Toxicity
Dow AgroSciences will conduct a freshwater fish early life-stage study (72-4) using
Rainbow trout as confirmatory data. As stated previously in this document, EPA believes that
1,3-D will undergo rapid rates of dissipation in most surface waters due to volatilization and, to a
lesser extent, by abiotic hydrolysis and possibly biodegradation.. However, given the high acute
' "I1*" ''I*,!,'''
"'i'1!1'1' :'''!:(,
f :"'" ! ' !' ':. ;Vi, !"', '
iji?' S" ?S' ''' 5*$^**''
i (ftow-throuj[ii or Static)
iiii;ii!ipii i i'ijiviii '. i 'ป Tii'i1 ' i i" i iiihii if js
llil'ii!,1' i ,,l|il|iซllllll LI, , 'brlii iliH , ' ;!ป' ,DII|ili| 1, "'I1 I || III ilili
ii* : twSii" ",J;ii: ,' i'. ' mi "Lirgcmouta Bass
HI*!':, i 1 1 "'i:!:* , Iliii1 (Micropiemssalmoides)
tJSi'iS'^.i'li,'^*^6 ป.>.'.. :,-.. M' " -,"
ft'ijvWli'.f* ^:> ' wfiRJ^jbioiw Trout".
ftซflฃ!?1"1'ii*L "'ll', i'1' ii ; (*ฐhnฐgf:'irdneri)
r:"'1 hSp ", " |,'ft^ic
||)! ["Ijiij ;S fi?!, .I' ''' .i ' ii'l !' !;;'!; J1', &$,? , ''i-!,1!1 ' '["'ilJI ;: iii!;'1''
jp,,,, ,,,;;:-,;,,:,:,_ ;,:.^. .;. ^^(lhcซ(ii5|Cnnoyf
-'- '"""--""' '-* ' "(Pf^^hates promelas)
ijj; lEJir ;,,,'; f'jj^' ,,; :;; iii;sjitic
,1111:, . ||ij[ j ; ; h, f., . , ,; |i|i ii j, , i; ;:, .;, ;_ ( | ; ; i. ;;, :, , ,i||| . _, ,,
tfl(!jJiU "i; a'Hlil;' " -..' ' : iW" Ratnbow Trout' '
(Salmo gflirdneri)
static
Blucgill Sunfish
; (Lipomi s macrochlriia)
jtttie
Bluc^U Sunfish
(Ltpomts macroctiirirus)
slide
HI H 'I'1 'll11 Bilgmsuifisn::"lll:i"!li "'' '
(Ltpomis maarochirtms)
sJaiie
1 Rated supplemental becaus
'",: >.' ;:;';": :","" sai'^"
''!' ' 'I'"1'" s'",,!!1!' 1','iS ' ft"1
96-hour
LC30 (ppm)
%ai (measured/nominal)
100 1.08 (measured)
100 3.65 (measured)
,^. ,.;...; ,:;;<; '.^.-''-f-^^^.iy:;?.;, f'
92 S.? (measured)
^'^i'.^Y;!'/.^*).^ '^''^'.(:Jti^f.''t.l'''''''i ;';[ '.
100 , 4.1 (meas.ured)
,' '!!';/ .,;. i..'1,,}*1 (1 ;. ..;. ".[('ir^H.i;!.: :'.;.' f 'si'"-1
92 5.9 (unknown)
>80 6.1 (nominal)
92 6.7 (unknown)
92 7.1 (measured)
e the dose levels were not high enough to calcuU
(ii) Freshwater Fish,
PV' V,; II, ;;:"; II 'SfiE i '. '.?;~.f?'.:.'
Toxicity Category
Moderately Toxic
Moderately Toxic
^.jj.^ [.^;: ;!.,; jjijf
Moderately Toxic
1;i^\ซi5'':'?,'i ,", '"' 'i-lif-:'
Moderately Toxic
i,,,!,;, ',|,! ', yi)' >;,,;_ ., Mjj1-;!
Moderately Toxic
, ;. ' ;
Moderately Toxic
Moderately Toxic
'
Moderately Toxic
ite an LDM.
Chronic
1 t-jirL,,,51;1;;;,;1-,:1!!';"1"1 :,3'I,S
MRID No. Study
Author/Year Classification
40098001/ Mayer Core
& Ellersieck/ 1986
; ' " ' . ', ' ' , '
4009800 1/ Mayer Core
& Ellersieck/ 1986
;:.,V' '",'; ' -;"' :'::"' "" '',' ' ':: "" :''\. .
00039692/ Core
Bentley/
1975
40098001/ Meyer Core
& Ellersieck/ 1986
. [' ,; i1 . ', , "':,' ':, , '' " ''' '"'
STEODI01 Core
USEPA
1977
00117043/ Supplemental1
Buccafusco/
1?81 ,
STEODI02 Core
USEPA
1977
:''!.!"' '" -r '.' ..; "': >., , '.' , :,
00039692/ Core
Bentley/
1975
',,"' "| '\. .; ' -:"'' ' ' ' ,: .", :. " ;. ,:
I" I'-:
68
-------
LC50 value and a half-life of 13.5 days, the Agency is interested in comparing the results to the
run-off study to gage possible exposures to freshwater fish on a chronic basis.
(Hi) Freshwater Invertebrates, Acute
Results of the freshwater invertebrate acute studies are presented in Table 19.
Table 19. Freshwater Invertebrate Acute Toxicity
Species/(Static or Flow-
through) % ai
Waterflea , 100
(Daphnia magna)
48-hour LC50/
EC50(ppm) ,
(measured/nominal) Toxicity Category
0,09 Highly Toxic
MRIDNo.
40098001/
Mayer &
EUersieck/
1986
Study Classification
Core
Since the LC50/EC50 is less than 0.1 ppm, 1,3-D is considered very highly toxic to
aquatic invertebrates on an acute basis. The guideline (72-2) is fulfilled (MRID 40098001). The
registrant is also conducting the 72-2(a) study on the degradates to Compare to the assumption in
,the risk assessment that the degradates are of equal or less toxicity to 1,3-D.
(iv) Freshwater Invertebrate, Chronic *
Dow AgroSciences has agreed to conduct a freshwater invertebrate chronic study (72-
4(b)) using Daphnia magna.
The data at hand on acute levels show that the LC50 for aquatic invertebrates (0.09 ppm) is
less than 0.1 ppm. Also, at all registered application rates, initial, 21-day, and 90-day surface-
water EECs, as calculated by GENEEC, are less than one percent of the lowest LC50 for
freshwater invertebrates. Hpwever,,because GENEEC is not suitable for tracking soil fumigants
and since EPA expects rapid rates of dissipation in most surface waters, EPA is less concerned
about chronic risks than for acute risks for aquatic invetebrates.
(v) Freshwater Field Studies
A freshwater field study using the TGAI is not required for 1,3-D.
d- Toxicity to Estuarine and Marine Animals
(i) Estuarine and Marine Fish, Acute
The 1986 Registration Standard did not require estuarine and marine studies. Useof
1,3-D, however, is expected to expand into areas, namely Florida, that could impact estuarine and
marine environments. The registrant has committed to submit by June 1, 1999 a study on 1,3-D
for acute estuarine and marine fish using the sheepshead minnow. Studies on estuarine and'
69
-------
llf WMOTI ..... IlilEl' ....... 'III'''';'!!
1 'li'iiiiiii,1 iijiiTJiiji''! ii11' Siiii1" in1, iiiiiiii* , p j ?-i:i -'in. . "iff'f. 'iWii'iiiii i""
:>:!hWii!i!,J;;:'!il!!i,,,li;llv '"* .' iiiiiiii!"' '''i'1' ,"' : : '' '^ "H ,: ,ซ'' :' ปi ' iiiiiiii i ''v
;i!!""i!'"', i i; I "I',1 , iii Wi, ' ป IP1,1,, I ' ' i1 '". '? , '' E V "
,, !'l! f'l1'!!!,! Hi,
"""!!" Ik I";*! i;: j,,, liUii
ri'iiiittliii1 '/iriilii .>
*1lh"l ' I1'1 , i ft'
: 'ii ii: , iiiiij:
nvjii1';^1 "'
1 PI , i.""T" ' I.,,,! i,1 'W'r,, , '"''
i,'" iiisrS:; ; ;:M|!"i".i.ii.i111
...IK."''!',:!! ' ,1 i,llift:,'"i1! lllli"!1':', 'I!1 'ill'liiilll I"
V11 .:,,l!itiii"i'i
I i;11!:!,!""!!!': lit -I11
,, ", "vl'lillll , IE.,1'
Sinarine.fish for the degradates are reserved pending the outcome of this 1,3-D acute study and
i-other, studies.
(ii) Estuarine and Marine Fish, Chronic
"1i!'ป ',, ', , ' I I | ,l',' 1' ',!''! ''! i, ' ," '
Ch^
Iriis tim^ TWs requirement will be re-evaluated after reviewing the freshwater fish toxicity
information.
(iii) Estuarine and Marine Invertebrates, Acute
Tjl^e registrant is conducting confirmatory studies on the mysid shrimp (72-3 (c)) and
Eastern oyster (72-3(b)) to test the toxicity of 1,3-D on estuarine and marine invertebrates. As
Ji^edllpye, ijjp use is expected to increase in areas and could impact estuarine and marine
".'' *|ny]rO|iments,
/ ^fT-I ,'''*:, HI . * ' '' ;/,., ; -,
'.,,, i jil;,,:',, :;, 'j:; ,. i;, ,j, 'ijiijii (iv) Estuarine and Marine Invertebrate, Chronic '
iiffi
11 A" r Ji1 + i j "' ,ii ''iiipKi
(.iiiiiii;?!.'
' if:,,-
'/.)::..
iliilii'}1, ill1 , 'i f ,ii'i ,,i, ,,; ,,i ,,111, i, ii lijii'i'iiiiiniiii ,i ' i i i ,.i i ; in _,^ ir1 ' i ' ' i ,,
Chronic tests of estuarine and marine inyertebrates using the TGAI are not required for
|?3-p at this tirnf. This requirement will be re-evaluated after examining the results of the chronic
freshwater invertebrate, acute marine/estuarine studies and the run-off study.
iP ; '] ,;' - ;; v:,:' . ''. ':!'.-(y) Estuarine and Marine Field Studies
,,'"'' . |,
'. , u , "
A field study in estuarine/marine environments using the TGAI is not required for 1,3-D.
e- Toxicity to Aquatic and Terrestrial Plants
''.'''' I:B. ': ; :') ' SKl1 " ', ". ,',. ', ' ,:' 't'"' if'iil!! '':' if '"v * *.:! ii1':1 i 11 .: ; 11 >,] 'i,. >i ,.-, ,'.,,, . -, ; . i. , i. . . , i ,' ,.
11111 '. -it'i", ' e ,' 3i ^Iiiiiiii v:S: :'?.;,::;,: .; : r ,; { iii}! v.; T ii,.'.j, ^.'VliAl1 ,ซ !' ! ' -H'"... -,"5 '. i'Mi.';',f:,;'' iliiii, .' ,.f ' :. ,! i1 '... ' I' , . !
pThe registrant has committed to conducting Tier I and Tier n tests for aquatic and
||rps|nal plants using the TGAI. These studies are being conducted because 1,3-D is labeled for
gse as^ an herbjidde and has phytotoxicity warnings. The registrant has also committed to
conducting Tier I and Tier II tests for aquatic plants for the degradates (3- chloroacrylic acid and
3-chloroallyl alcohol)!
' i .Jini'iin 'i; ปin! :*
iiiJ1 i> ''liil-i:" .ip I'in
fl Toxicity of Degradation Products and Manufacturing
:ฃ '. Impurities
'ซ ' iii,,"I, ' i n mill n i n | ''': :,''''
No data were available to conduct a full ecological assessment for 1,2-D, 3 -chloroallyl
ajcphol or 3-chloroacrylic acid. All of these chemicals are considered at least as toxic as the
pared:. As noted throughout this section, the registrant is conducting various environmental fate
|nd epqtoxicity studies on tfie degradates.
70
.' in1";1. hJ"i ',;"'
I U!!!! 'iliniiiiil.:!!; /i1.
-------
4. Exposure and Risk Characterization
a.
Explanation of the Risk Quotient (RQ) and the Level of
Concern (LOC)
Risk characterization integrates the results of the exposure and ecotoxicity data to
evaluate the likelihood of adverse ecological effects. The quotient method is used to integrate the
results of exposure and ecotoxicity data. lathis method, risk quotients (RQ's) are calculated by
dividing exposure estimates by both acute and chronic ecotoxicity values.
\ ' .,.'"-
RQ = EXPOSUKE/TOXICrrY
RQ's are then compared to EPA's levels of concern (LOC's). These LOC's are criteria
used by EPA to indicate potential risk to non-target organisms and the need to consider
regulatory action. The criteria indicate that a pesticide used as directed has the potential to cause
adverse effects on non-target organisms. LOC's currently address the following risk presumption
categories: (1) acute high - potential for acute risk is high and regulatory action may be
warranted in addition to restricted use classification; (2) acute restricted use - the potential for
acute risk is high but may be mitigated through restricted use classification; (3) acute
endangered species - the potential for acute risk to endangered species is high and regulatory
action may be warranted; and (4) chronic risk - the potential for chronic risk is high and
regulatory action may be warranted. Currently, the Agency does not conduct assessments for
chronic risk to plants, acute or chronic risks to non-target insects, or chronic risk from
granula^ait formulations to mammalian or avian species. '
The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic
risk quotients are derived from the results of required studies. Examples of ecotoxicity values
derived from the results of short-term laboratory studies that assess acute effects are: LC50 (fish
and birds), LD50 (birds and mammals), EC50 (aquatic plants and aquatic invertebrates) and EC25
(terrestrial plants). Examples of toxicity test effect levels derived from the results of long-term
laboratory studies assessing chronic effects are: LOEC (birds, fish, and aquatic invertebrates),
NOEC (birds, fish and aquatic invertebrates) and MATC (fish and aquatic invertebrates). For
birds and mammals, the NOEC value is used as the ecotoxicity test value in assessing chronic
effects. Other values may be used when justified. Generally, the MATC (defined as the
geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in assessing chronic
effects to fish and aquatic invertebrates. However, the NOEC is used if the measurement
endpoint is reproduction or survival. Risk presumptions, along with the corresponding-RQ's and
LOC's are listed in Table 20.
71
-------
y
Table 20. Risk Presumptions for Terrestrial Animals
11(1,1 111 1 III Ill 111 III 111 Ill II 1 III
'I' ii mi' ซi Risk Presumption
Birds
Acute High Risk
'"'I i il"1 m "Acute Restricted Use
1 || 1 "i" |lj Acute Endangered Species
Chronic Risk
Wild Mammals
Acute High Risk
"I||| " J ||V| Acute Restricted Use
i iillll 1 1 i 1 l i llll i i
Acute Endangered Species
Chronic Risk
Mil II 1 1 1 i v
RQ
i1. - i ,. 1 '''. .';.'>. ;;."."' . ailt 111;1,:!';
LOG
EEC'/LCSO or LDSO/sqft1 or LDSO/day3 0.5
EEC/LC50orLD50/sqftorLD50/day(orLD50<50mg/kg) 0.2
EEC/LC50 or LDSO/sqft or LDSO/day 0. 1
EEC/NOEC 1
EEC/LC50 or LDSO/sqft or LDSO/day 0.5
EEC/LCSo'or LDSO/sqft or LDSO/day (or LDSO < 50 nig/kg) 0.2
ii i ii .:ป, '.- .!' , ... :'. r ''!!
EEC/LCSO or LDSO/sqft or LDSO/day 0.1
EEC/NOEC 1
1 abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items
* msfif * ma of toxicant consumed/day
LDSO ป wtof bird LDSO * wL of bird
iiii1 iiii nil i i i n i i i ii i ' i ,
Table 2 1 . Risk Presumptions for Aquatic Animals
Risk Presumption
,i|"i | if i llll1 ! i I1 111 i 1 111 1 i i 1
|,l i l| i Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
"Hi i 'I ' III' ' EEC -(ppm or ppb) in water
II I'll 1! i l M i '
Table 22. Risk Presumptions for Plants
Risk Presumption
1 1 i 1 1 Terrestrial and Semi-Aquatic Plants
Acute High Risk
Acute Endangered Species
XitX.-f't.t. !:'' IllIB' Acute High Risk
Acute Endangered Species
RQ
l" 1 1 l i i i i i l|i
EECVLCSOorECSO
EEC/LCSO or EC50
EEC/LCSO or EC50
EEC/MATCorNOEC
L
f
RQ
EECVEC25
EEC/EC05orNOEC
Aquatic Plants
EEC2/EC50
EEC/ECOSorNOEC
"'.' -, ' . ! , ''
LOG
:...ป. '.''.': '... V.I
0.5
0.1
0.05 '
'. . I' M'!' - ," '" /'Jii'1. .',);.-'
toe ' '';': "'""
i
i
i
i
.,ป EEC-lbsai/A
,? EEC - (ppb/ppm) in water
"II1' FJIP'ISii"'1 ".l1 LiliL
."IliiLi,/:,,
ii i lit1 ;
ni i!/'1'.PiiJ";." .,! lilii.'! ,, .. J1'1.,,:,! '.ป;,!.mi
::a^^ i;; ______
..... !ii,m^^^ ..... ..... r: ..... iM ..... ...... J'::'i!!!i ..... ...iii
:' ........ jv ..... /:: ........................ . ....... ^l ......
-------
For pesticides applied as nongranular products (e.g., liquids/dusts applied via broadcast
methods, etc.), the EECs on food items following product application are compared to toxiciry
values to assess risk (Fletcher et al., 1994). However, the Agency currently does not have
routinely used methods for predicting EECs for soil fumigants. When available, risk
determinations can be made when actual concentrations have been reported in terrestrial field
' dissipation studies or other studies submitted in support of reregistration.
b. Field Data Used for Risk Assessment
In this assessment, post-application 1,3-D residues detected in'soil, water, and air samples
are compared to tpxichy values. It should be noted that .this risk assessment relies on very little
data, measured or predicted. It should also be noted that the reported field studies were
conducted with lower application rates than allowed,on some crops. 1,3-D concentrations in soil
water, and air will be higher with corresponding higher application rates. However the risk
quotients calculated from the environmental data do provide information about the potential risk
of 1,3-D application to non-target species. In some instances, extrapolations were made to higher
application rates, however, these levels are a simplification of what actual levels may be
Environmental fate and air monitoring study results have not established a correlation between the
level of applied product and subsequent levels in the environment.
Two terrestrial field dissipation studies (MRID's 40403301 and 40855501) provided
1,3-D residue concentrations in treated soil and subsequent dissipation rates. A prospective
ground-water monitoring study in Florida yielded 1,3-D concentrations in water collected from
ditches adjacent to treated fields (MRK> 44005201). Three field volatility studies evaluated
atmospheric concentrations of 1,3-D under field .conditions (MRID's 42545101 41057701 and
EFGWB 91,0910). '
c. Exposure and Risk to Non-target Terrestrial Animals
1,3-D is used on over half a million acres of cropland each year (see Table 1) For
orchard trees and grapevines, approved rates are as high as 556 Ibs a.i./A. However, because the
application method reduces terrestrial exposure and because of the relatively low toxiciry to
mammals, its use is not expected to result in large incidents of mortality. No avian mortality
incidents have been reported in relation to 1,3-D applications. Telone C-17 contains chloropicrin
which is a contact irritant to humans and serves as a warning to applicators. It is assumed this
product could affect birds and wild mammals in the same manner, resulting in avoidance and
thereby reducing the risk of exposure. ' ,
The Agency does not have a standard protocol for conducting'terrestrial risk assessments ,
on terrestrial organisms when chemicals are applied via soil injection methods: Instead in this
nsk assessment, animals were assumed to be exposed through dietary intake of contaminated soil
Beyer et al. (1994) analyzed scat samples from a variety of vertebrate species to determine the
percent of soil in the diet. His work showed that the quantity of soil in animal diets can range
from less than two percent up to 30 percent. Animals can ingest soil intentionally to provide
73 ' ' :'-.'-
-------
if? 2% to 30^4) of the total daily food intake and a daily food consumption rate of 18% of total body weight EECs are taken from a field
dissipation study submitted to the Agency (MRID 40403301).
:: .,'.: :,VM; ^M1 ,,S':'!Jr;;:;,::; . .|, : 7~ '. . ~ ~ ~ ~
Application Rate and
Injection Depth
AvianLDj0
Daily Soil Ingestion
Rate1
RQ
ป!? 'jr. ;.i ('""liiiii! -"i1;1"'!1"1;
342 Ibs aUa.cn
(13-15 inches)
(404033-01)
:M: ...... '.' :: ! 'fiAnrt ...... ป. > " "iiasi! ', \ ป;. ' s ,* J'l1'?: <.f& -"ney ...... w,i i ! ..... "ซ< ! , ...... ป it :n ........ inii ...... * ..... jaij t ......... isi ; ...... I
130
152
Mean =10.6%
Range = >2 to 30%
, ,
Mean =0.02
Range = O.003 to 0.05
1 Soil consumption values are taken from Beyer et a!. 1995.
From Table 20? the LOC's for avian species are: 0.5 (acute high risk); 0.2 (acute
restricted use); 0.1 (acute endangered species); and 1 (chronic risk). An evaluation of the
above risk quotients shows that no LOC's are exceeded for avian species. If it assumed that the
concentration in soil is directly proportional to the application rate, the EEC would be 208 ppm at
the highest rate of 556 Ibs a.i./acre. At this concentration, no LOC's were exceeded. At this soil
concentration, a 100-gm bird with an LD50 of 152 nig/kg would need to consume 72 grams of soil
to attain this equivalent dose. This evaluation indicates that j^.g use should not result in,
significant acute mortality to avian species under any application scenario.
"I13 11' iVi'i,.!.; >: :,:-ซ I; I!,1 : ; ',iv
i;'"'(}':,:.,'! ni,, '< -tin.
74
-------
No ayian chronic test data were required to support reregistration. Since 1,3-D is
generally only applied once per growing season and because it has a relatively short field
dissipation half-life, it is hot expected to result in long-term exposure or subsequent chronic
effects. ,
(ii) Mammals
Because of the application method, the use of 1,3-D in chemical soil fumigation operations
is not expected to present a significant hazard to mammals. However, exposure could, occur
through both dietary and inhalation routes. No incidents of mammalian mortality have been
reported due to the application of 1,3-D.
Risk quotients were calculated from field dissipation data and laboratory mouse LD50 data
using the following equation:
LD2% to 17%) of the total daily intake and a daily food consumption rate of 95% of total body weight EECs are from
afield dissipation study submitted to the Agency (MRID 40403301).
Application Rate and
Injection Depth
(MRID,#)
342 Ibs ai/acre
(13-15 inches)
(404033-01)
EEC (ppm)
, 130
Mammalian LD50
(mg/kg) :
640
Daily Soil Ingestion
Rate1
Mean = 4.4%
Range = >2 to 17% ,
RQ
Mean =0.008
Range = <0.003 to 0.03
From Table 20, the LOC's for mammal are as follows: 0.5 (acute high risk); 0.2
(acute restricted use); 0.1 (acute endangered species); and 1 (chronic risk). Evaluation of
the above risk quotients show that no LOC's are exceeded for mammalian species. If it is
assumed that the concentration in soil is directly proportional to the application rate, the EEC
would be 208 ppm at the highest rate of 556 Ibs a.i./acre. At this soil concentration, a 20-gram
mouse with an LD50 of 640 mg/kg would need to consume 61 grams of soil (three times its body
weight) to attain this equivalent dose. Therefore, 1,3-D use should not result in significant acute
mortality to mammalian species via dietary exposure under any application scenario.
Acute inhalation toxicity was assessed by comparing mammalian inhalation data to the
amount of volatilized chemical found above the treated fields. Using an application rate of 346
Ibs a.i./acre, 1,3-D concentrations at a height of 6 inches above the soil surface never exceeded
4.4 ppm. This value is less than 0,01 percent of the mammalian inhalation LD50 of 713 mg/kg.
75
-------
iiiiniigii'iiiri'iiiggigipn!ii'ii'iiiiivgiiiggi:!' i n: '*\:' mw s"T^ "i:;" rw*! ' wr*
illililllini'iirlllil'Kill;1! i!!!:!,,," Illlil'llii'H'1
Wiliii' I' SPpi,"!'1!1'! ill II'1111
'Hill!!,, 'liii*
*
v/
I!5" ;i!;
i
mm
ง
> ..... "ป!* ..... tin*
I ","ill
II!,"'/ I'1!'!!? If"! ft "
':ii
:i|Ei|iซlli!,| J" ,1, |? N. 'J' ,:'"!, ,'I,; ';;! ; h:,]:,! '; I l||!;||||l|l ' , fc, ,p V"'" ','|.',"," -i 'I'll i11 !,,'>' I'",' '" hi," !il ,' "T: 'MM I1:1"1 !'"! !v',' !! ",' ' I, "J ! " 'i 111! i!,i 'ป, *:,, " [," ' '- ,
iKnilKI1 .I'l'ili II, ' ' i!"i,i '. V i lisiil'ii'.'.liii ill ' lr,"",i '"i''',i:' ," I'"'11!1 T* 'i ' i, y ป '!.,'! "' .1" hi1 '"" ', ''"' 1 ',!'!'Vs '"i..';'11'1'"" i1 'i.nlll '''i1, '
Even if 1,3-D concentrations in the air are directly proportional to the application rate,
atmospheric concentrations are not expected to reach toxic levels. This result also indicates that
1,3-D use should not result in significant acute mortality to mammalian species via inhalation
exposure under any application scenario.
li.*;:
Pill , F
Chronic toxicity is normally assessed through dietary routes of exposure and soil can be a
substantial portion of the diet. Using the assumptions of the acute assessment and substituting the
reproductive effect NOEL of > 90 ppm for the LDSO, the chronic LOG is not exceeded. Chronic
IJsk can alsoiLbe .assessedby using the NOEL of 5 rng/kg/day derived in the 13-week rat feeding
Study. The following assumptions are used for this calculation:
i- a mbu|e weighs approximately 20 grams, so the NOEL per mouse would be 6.1 mg/day;
- a niousej eats the equivalent of 18 percent of its body weight per day and a maximum of
17 percent of the diet is soil, which equates to 612 mg of soil per day;
; if! soil LSiD concenfrations, wejg 2,08 rng/kg soils at an agplication rate of 556 Ibs
;; v|4./acrej each gram of soil would contain 0.208 mg. 1,3-D; and
- fqllowjng mese assumptions, a mouse would consume 0.127 mg of 1,3-D per day.
Using tfie above scenario, the chronic RQ is 1.3, which exceeds the LOG. However, this
[M(^eiii.WKima3dmumi exposure condition. If factors such as the average concentration of 1,3-D
over a 13 weekpenoS'^iz; ppm at a.'seven day field dissipation half-life) or soil consumption rates
mgr,e typical of small mammals are used, the LOG is no longer exceeded. Since 1,3-D is applied
generally only once per growing season and because it has a relatively short dissipation half-life,
; not expect long-term exposures.
; ' inillj !"! 'i, ;, ', " !' i I ,:',,','!''
(iii) Terrestrial Insects
'111"!1 ,"!/! !irl
Wi.'lr : !!
:'SE'r:I:'T'i;:'Jhe Agency currentiy does not assess risk to non-target insects. Results of acceptable
l^udjes are used for recommending appropriate label precautions.
d. Exposure and Risk to Non-target Freshwater Aquatic Animals
Exposure of pesticides to aquatic non-target organisms is possible through surface water
toxicity reference values.
11 11111
(i) Freshwater Fish
IN ' i in 'i i ' ' i < ii i
Acute and chronic risk quotients are presented in Table 25.
76
-------
lack of chroni
Site/
Application
Method/ Rate in Ibs
ai/A
=====
177
253
354
404
556
LC50
(ppm)
=====
1.08
1.08
1.08
: 1.08
1.08
NOEC/
MATC
(ppm)
-
nd
nd
nd
nd
nd
EEC
Initial/Peak
(ppm)
zss^sssas^sss^^^s^^s
0.685
0.980 , '
1.380
1.570
2.160
EEC
90-Day Ave.1
(ppm)
[ a=a=g=aa
0.006
0.008
0.012
0.013
Acute RQ
(EEC/LC50)
=======
0.63
0.91
.1.27
1.45
2.00
Chronic RQ
(EEC/NOEC or
MATC)
nc '
nc
nc i
nc
1 56 day concentration was not modeled
nd =nodata
nc = not calculated
From Table 21, the LOC's for aquatic animals areas follows: 0.5 (acute high risk)-
0.1 (restricted use); 0.005 (acute endangered species); and 1 (chronic). The results of the
GENEEC model indicate that aquatic acute high risk, restricted use, and endangered species
levels of concern are exceeded for freshwater fish at application rates equal to or above 177 Ibs
a,i./acre. Chronic risk could not be determined because of the lack of chronic toxiciry data.
Because GENEEC is not suitable, for tracking soil fumigants, EPA believes that actual
residues may be a better indicator of exposure and risk. The freshwater fish LCSO (1 08 ppm) was
compared to actual residues detected in perimeter ditches adjacent to fields treated at an
application rate of 182 Ibs a.i./acre (MRID #44005201). Concentrations ranged from 0.34 ppb to
1.8 ppb. The resulting risk quotient ranges from 0.002 to 0.0003 which does not exceed any
LOG. If residues in ditch water are assumed to be directly proportional to the application rate
then at 556 Ibs ai/acre, concentrations in ditch water would reach 5.5 ppb. At, this concentration
no LOC's are exceeded. .
Concentrations of 1,3-D in ground water four feet below the surface in Florida reached a
maximum of 833 ppb. At this concentration, the acute high risk LOG for fish would be exceeded
by 1,3-D alone by 1.5 times. This assessment does not account for the additional toxicity
presented by the two degradates that were also found in ground water in Florida. Note that there
can be considerable interaction between surface and ground water, thus, the levels found in
ground water are relevant in a discussion of exposures to fish.
s '
(ii) Freshwater Invertebrates
The acute and chronic risk quotients are presented in Table 26.
. 77
-------
tl'llllltlll'l ', II I'lll' I 1 ' lllll
I1! HI li'i Ii1 ' n! 'ill
'1 M, ' 1 \ T^'il RiskQui
due to the lack of chroi
i i 14 i i
in 1 ( i hi i ' ii i I
ii i i ii ii i n in 1 1 i u i1 IN
nts for Freshwater Invertebrates Based on a Daphnia. LC50 of 0.09 ppm. Chroni
lie toxicity information.
Site/
> . ' " i i
Jl '' "
.... if i i
c risk quotients could not be evaluated
Application NOEC/ EEC EEC Chronic RQ
pi ,|| | IPH fylcthod/ Rate in Ibs ai/A LC50 MATC Initial/Peak 21-DayAve. AcuteRQ (EEC/NOECor v
(ppm) (ppm) (ppm) (ppm) (EEC/LC50) MATC)
177
'III i 1 I 1 1 II il
253
in i in
354
1 11 'Hi lilii 404
556
0.09 nd 0.685 0.025 7.61 nc
1 i i i I .",'.. '"i / " .. ": if! (i;.1
0.09 nd 0.980 0.035 10.89 nc
0.09 nd 1.380 0.05 15.33 nc
" ' '- r . "'1 'I,
0.09 . nd " L570 ' 0.055 "' 17.44 ',' ." no
0.09 nd 2.160 0.080 24.00 nc
..I if ., i , ' '!,!! i ; ji'M,,1,,,,
MM 1 ii 111 i 11111 i nd "no d&t&
|II i'1",1 ' ill'1 i ill ad -not calculated ' " ' '...'. "~ '.'.
From Table 21, the LOC's for aquatic animals areas follows: 0.5 (acute high risk;
0^1 (restricted use); 0.005 (acute endangered species); and 1 (chronic). The results indicate
that aquatic acute high risk, restricted use, and endangered species levels of concern are exceeded
for freshwater invertebrates at application rates equal to or above 177 Ibs a.i./acre from the
i if, fiMJsiJirf '''"r'1 ' Wr(|!EJ|EECฅinodei. ...Cfapntejoxicity could not be determined due to a 1
When ffie LC50 (0.09 ppm) is compared to actual residues (MI
perimeter ditches adjacent to fields in Florida treated at an application
iCll:fSfail!l i'v'< iEfan^3 from 1.8 ppb" to 0.34 ppb. The resulting risk' quoSents range f
0,004, which do exceed the endangered species LOG. If residues in c
I be djrectiy proportional to the application rate, then at 556 Ibs a.i./acr
lif JlifS^^'i:''^ i' B^i^'^^^^li 3UO#. JP, 4-4 PPb- At concentrations above 4.5 ppb,
If""1' " '' "' are" exceeded. " ' "'" ""'
H'l" iilJi'i'W'JJI1 HI..1!'1*1 ' i, I1 " IIIIEI.!.!'!1 l!.1!1 ' '' J1 | Til!.!
1 . JBH* !' V ' ' ' !' ..... Ml.'', . | ((I || . I 1 II
1 Concentrations of 1,3-D in ground water four feet below the s
liJ.'il'.ll'ifcli'Ht ' i Illlli!"1* "'"Wi ' "ซ "t "" '" l!""" i "i11" "" ! " ' ' n'inSJi '"' V "W*.:l ' ' '" ' '2 *"L-' ' "li "
I in Florida reached a maximum of 833 ppb. At this concentration, the
I invertebrates would be exceeded. This does not account for the addit
ack of toxicity information.
I/.', .J, ... ^.j,' ^ ซr'fl ;!. j. ' ' ',"
OD #44005201) detected in
rate of 182 Ibs a.i./acre
rom ranges from 6.02 to
itch water are assumed to
e, concentrations in ditch
endangered species LOCs
urface at the application site
acute high risk LOG for
onal toxicity presented by
the two ^g^g^gg th'at'w-ere" ^sb fo'uncTm this 'ground water." Adduionally, concentrations
remained at potentially toxic levels for approximately 60 days. In addition to i,3-D movement in
aquatic environments through ground and surface water interaction, shallow ground water is itself
inhabited by aquatic invertebrates.
e.
Exposure and Risk to Estuarine and Marine Animals
. |j U'"'f,''lXji''K9!t9?a2W inibrmationLfbr estuarine and marine animals were'required in the 1986
-. j ft
Registration Standard. Consequently, no risk analysis could be conducted for these types of
organisms.
riSliii ft; (?'.:. ป,;ii
I ,!>! fiiB.",,: . . iiiiiti;
.ivt,: . >." ' ป. .ill! ! ,'': : ป" ;. > ",. -.,$ . !:; m*. i ..... .-i^lm-: -m, S ..... y :: - \ -I- ,; *;
>, ; ..... \,> > , ...... ..... : i i t& ....... . 4S-W ( , i; 1 v ." .< /.' : ' '
'CIPQII1' .llil.'llili.:
78
, ' 4!!1'1.! M ปi:,' ,' ' if!",) II',../ "'"'I1 * T.i'H ''': .n:'!,',.'1'"!"1"1 ' \tf ,*
in \i ' HII S TIT
-------
The registrant is conducting several estuarine and marine studies on 1,3-D The tests are
estuanne/manne invertebrates with the inysid shrimp (72-3(c)) and the Eastern oyster (72-3(b))
and[ estuanne/marine fish using the Sheepshead minnow (72-3(a)). Should the results of these
studies and other toxicity studies on the degradates show a potential for ecotoxicity from the
degradates, EPA will also require studies on the degradates for estuarine, and marine animals.
f. Exposure and Risk to Non-target Plants
No toxicity information for non-target plants were required in the 1986 Registration
Standard. Consequently, no risk analysis could be conducted for these types of organisms The
registrant has committed to conducting Tier I and Tier E studies for 1,3-D (aquatic and
terrestrial) and its degradates (aquatic). These studies are scheduled to be submitted by October
iy jฃ.t(J\J\J. ' i ' "
g. Endangered Species
The Endangered Species Protection Program is expected to be finalized in the future
Limitations in the use of 1,3-D will be required to protect endangered and threatened species but
these limitations have not been defined and may be formulation specific. EPA anticipates that a
consultation with the Fish and Wildlife Service will be conducted in accordance with the species-
based priority approach described in the Program. After completion of consultation, registrants
will be mformed;if any required label modifications are necessary. Such modifications would most
likely consist of the generic label statement referring pesticide users to use limitations contained in
county bulletins.
IV, RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
' - ' ' - ' ' :
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active ingredient
are eligible for reregistration. The Agency has previously identified and required the submissions
of generic (LC. active ingredient specific) data required to support reregistration of products
containing 1,3:D. The Agency has completed its review of these generic data and has determined
that the data are, sufficient to support reregistration of 1,3-D. Appendix B identifies the generic
data requirements that the Agency reviewed as part of its determination of reregistration eligibility
of 1,3-D, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of 1,3-D. The Agency has determined that 1,3-D products, when used as
specified m this document (i.e. only pre-plant soil fumigant uses and according to label
requirements to include the pending restrictions listed in Table 31), do not result in unreasonable
adverse effects to human health or the environment. Therefore, the Agency finds that products
containing 1,3-D as the active ingredient are eligible for reregistration. The reregistration of
79
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'i; i rain mi i;,!!ป;, ,ii uiiiiiiiipi ' , jiiiiini 1i ,'",, ,! iiipi"1!, 1,1 liiiiiUI i' !:!!'ii,|i|,,"i, ii , fi"',!",i" :!,!,'i'I11 LnK :!;; ซ; UK ; :,',.;,:/"*, , 'i,'!. !!,i ", r ,"'!!" ii1 :'l,' t h1" , ' ,
particular products is addressed in Section V. of this document. Note that products which also
uw^ijjl .>;!'.: '_ il||taitf ;;c|i|gropicrin will not be deemed eligible for reregistration until the reregistration of that
active ingredient has been completed.
jiiijijii i iiiri'i" i! ii!!1 t , .liEF!: \r. t- ? 11,ซ. ii;1 \ i i ; Bill. r,,~;-, 'ซ ,' ''.; T Hi!; >ra; - ; aft , ;y t . :, ; <;;,.'j .'>:' ' i _ ,, .<!" * ,i -as . n
,,.. ;Jhe Agency made its reregistration eligibility determination based upon the target data
Jjase required for reregistration, the current guidelines for conducting acceptable studies to
1 '*' ""'" l"i; '"''' "Illfeffle such'data," piฃ^ Alffiougri'tfie"Agency has found that all .'
5งgS of1,3-D are eligible for reregistration when used according to specifications in this
document it should be understood that the Agency may take appropriate regulatory action and/or
illi.,1 'ii ซ!,',,i',.!.,, '[, ;ii|llini|, i, , " lllliilll,ฅ,lWhiil!!, I'll I'" * , in i ,,,,'PI. ,n i" 'it M i,,,"',i, 'I'M" i ', 'ii ," ,' ,ni",,'"i...i' r'i'ii, 'i,i,,.,!Hl, / t r, , f; I: .F ** ^ ,
llquife the submission of additional data to support the registration of products containing 1,3-D
if new information comes to the Agency's attention or if the data requirements for registration (or
the guidelines for generating such data ) change. This includes the results of the studies now
on the degradates, the run-off study, and the tap water monitoring program.
i';;:: :ys]l ;;; K;; ,;, jฃ;,",";,",;;:: ,,B, Determination of Eligibility Decision
J ::wa"'': ir;J?! SH "!;:!'!:'''''"'*'S^^yT&&&^i''''1'::;' ;"::::'::"":':"'' ''"'":*" '"L'"'' :':'""""'' ''' ';"'''";* '"*""
'.;*j^asi&d on the reviews of the generic data for the active ingredient 1,3-JD, as well as other
1ง|| generated for the 1,3-D Special Review, the Agency has sufficient information on the health
effects of 13-D and bnlts potential for'ground w^er contamination. The Agency has determined
that 1,3-D products, labeled and used as specified in this Reregistration Eligibility Decision
I document, will not pose unreasonable adverse effects to humans or the environment. Therefore,
! |h,e Agency concludes that all products containing 1,3-D, when used under the conditions
Specified in this document, are eligible for reregistration.
. i , ,,.,,, " , . ,;
ปij.' 5; 'I',, i iiij ;'C. , (^iejgulatory^ Position
'^'^:';"' \i'r 'i: :;f!-;The fbjlfflvjng'isa 'summary of'tn'e regulatory positions an5 rationales for managing risks
Q$f~ '<"" |l|S5cikted!wii3h.' tfie use of J,3-D. Wfiere trie registrant has committed to labeling revisions that
are not yet on 13XD labels, specific languageis setforth in Section V. of this document.
jfyyt ii :,,': j||jst;!?;'j>f;/.:' >'-:'!'11,j;]i|!''';J1!;.11 ;>- ;.r,;sri:;,!;ฅ;,w^t-ssw;r-ipj;;*ปf!sf^ji,t;. "J'." ป.:*!''*:?;( f.,; '***: :; i ", j- <;;;';, ,:...'. . "; . ,:;. :;; $'*
1. Summary of 1,3-D's Carcinogenicity
EPA has classified 1,3-D as a B2 carcinogen by both the oral and inhalation routes of
exposure. Dow AgroSciences has submitted information in SuppO"rt of having EPA regulate
1?3-D as a non-linear carcinogen. EPA conducted a preliminary review of the information and
regulation of non-linear carcinogens are finalized.
80
; t'
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2. Summary of EPA's Approach to the 1,3-D Risk Assessment
a. Tolerances, Codex Harmonization and Dietary Risk
EPA has determined that 1,3-D, when applied as a pre-plant soil fumigant, is a non-food
use pesticide and therefore, tolerances or exemptions from the requirement of a tolerance, are not
required. (There is one exception for pineapples, which are treated at plant but show no residues
since fruit are not borne until three years later). Therefore, a review of tolerance actions under
the safety standard established under section 408(b)(2)(D) of the Federal Food, Drug and
Cosmetics Act, as amended by FQPA, is not required. .1,3-D is regulated under the safety
standard established under Section 3 of FIFRA, whickrequires that no unreasonable adverse
effects to human health or the environment be associated with use of a pesticide. Nonetheless,
EPA has reviewed the data base for 1,3-D to determine whether infants and children are
particularly susceptible to toxic effects from exposures to 1,3-D residues and whether aggregate
and cumulative exposures pose unreasonable risks.
No tolerances or Codex MRLs have been established; therefore, there are no issues
regarding the compatibility of MRLs and tolerances.
Although there is no dietary risk from foods, EPA's risk assessment assumes dietary
exposures to come from water sources (ground water). Results from the Florida study suggest
that 1,3-D may enter surface water as volatilized residues in the air, settle into surface water and
then dissolve. This route, however, is considered insignificant and the registrant is conducting
studies to confirm that surface water is not a significant source of exposure.
EPA also looked to see if infants and children have increased susceptibility to the toxic '
effects of 1,3-D. In making its determination, EPA considered the completeness of the database
for developmental and reproductive effects, the nature of the effects observed and other
information. Based on the .current data requirements, 1,3-D has a complete database for
developmental and reproductive toxicity. Therefore, EPA has concluded that an extra uncertainty
factor of 10 is not warranted in order to protect infants and children. ,,
No acute toxicological endpoints were identified for 1,3-D exposure for any population
sub-group under labeling as specified in this document. For 1,2-D, the levels found in the ground
water studies were 20 to 3.0 times lower than the Office of Water's 10-day Health Advisory for
children. .
Dow AgroSciences is developing data for reregistration on the toxicological profile,
including developmental toxicity, for the alcohol and acid degradates. For purposes of
reregistration, the Agency assumed that the,degradates possess the same toxicological profile as
the parent
81
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Ill
b. Aggregate and Cumulative Risk
EPA considers the main sources of 1,3-D exposure to be inhalation and drinking water
from contaminated wells, especially for residents who live near treated fields. Aggregated cancer
risks (inhalation plus water) for residents who live near treated fields based only on the
information that allowed quantification of exposure are approximately 1 x 10"5. This estimate
does not include alt of the mitigation measures to reduce inhalation risk, nor does it take into
account a 100 foot no-treatment buffer from drinking water wells. While there are no data to
assess the potential for risk from surface water residues, EPA believes this would be an
insignificant source of exposure. Based on use patterns, dermal exposure is considered to be
insignificant EPA also looked at whether the Agency should also provide estimates of
Simulative risks with the contaminant, 1,2-D. EPA does not have available data to determine
whether 1?3-D has a common mechanism of toxiciry with 1,2-D or other substances. For
purposes of thisreregistration action^ 'EPA hasassumed that 1,3-Dand 1,2-D do not have a
common mechanism of toxicity.EPA has determined that exposures under the current use
patterns meet the safety standards set by FFDCA and FIFRA.
Ill I I I III II II I I :,',:",!"',
c. Effects to the Endocrine System
EPA is required to develop a screening program to determine whether certain substances
(including ail active ingredient pesticides and merts) "may have ah effect in humans that is similar
to an effect predicted by a naturally occurring estrogen, or such other endocrine effect." The
Agency is currently; worHng withInterested stakeholders, including other government agencies,
public interest groups, industry and research scientists in developing a screening and testing
program and apriority letting; scheme to implement this program. Congress has allowed three
years from the passage of FQPA (August 3, 1999) to implement this program. At that time, EPA
may require further testing of this active ingredient and end-use products.
"^"'a\ MI'I n [: "f:!. [^ ]n 'h '',' " ^ v"ii l.y "iinii :""|i''ii'" "n '"IM '",'' ^i",' j, ^'t 't 'i'",,,'
In deciding to continue to make reregistration determination during the early stages of
FQPA implementations!,"EPA" recognizes that It will be necessary to make decisions relating to
FQPA before the implementation process is complete. In making these early case-by-case
decisions, EPA does hot intend to set broad precedents for the application of FQPA to its
regulatory determinations. Rather, these early decisions will be made on a case-by-case basis and
will not bind EPA as it proceeds with further policy development and rulemaking that may be
required.
I'l ' ซ ' Mill .,' i . '.., ' .. '.- ',],- ...I i ;,; Ji ,,;::,,! r,.j, N , " ;. i',11:;':1 ,i, .'. ft, ' :',[, . ' ' '
EPA may determine, as a result of this later implementation process, that any of the
determination described in this RED are no longer appropriate. In tins case, the Agency will
IN; iiin,,!!, I,,!! ' IJIIII"''! "'h'fl'f'lii'i'i IN If, i \T iji if (i1 |'|iiii!',|', ii 'i.iiiiMiR Miill !|lliปW if i'h nn I1 W'H III1 liliiN1 111"1!, hiirT^ ปn *.iiiifi' "i 'iiif!".1!! I'jn1 n "i * .' i i ' >
consider itself free to pursue whatever action may be appropriate including, but not limited to,
III i, iff"! ft iiniiii ti'',,f, , r- ft. i ,,. .. ,
reconsideration of any portion of this RED.
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2. Summary of 1,3-D's Benefits
1,3-D is one of the few remaining registered soil fumigants used to control nematodes
Nem'atodes are microscopic soil worms that live in the soil spaces. Nematodes cause damage by
damaging the roots themselves (thereby doing the most damage to root crops such as carrots and
potatoes), by reducing yields and by creating opportunities for other soil pathogens to enter the
plant. 1,3-D is also used to control wireworms and rhizomania. The combination product of
1,3-D and chlorbpicrin is also used to treat nematodes and fungi.
The benefits of 1,3-D use are expected to increase with the phase-out of methyl bromide,
mainly for use on tomatoes and strawberries. Additional research may find alternative uses for '
1,3-D, or it is possible that other nematicides are identified or developed to replace both methvl
bromide and 1,3-D.
3. Summary of Risk Management Decisions
1 \ ' . -
a. , Human Health
- (i) Dietary
The Agency has determined that dietary exposure and risk associated with the use of
1,3-D under current labeling are negligible.
Exposure through Foods Grown in Treated Soils. Data show that no residues of 1,3-D
or its degradates of toxicological concern are found in crops grown in treated soils, as long as'
1,3-D is applied as a pre-plant soil fumigant. 1,3-D labels suggest a wailing period of one week
for every 10 gallons of 1,3-D applied between soil treatment and planting, based on phytotoxicity
concerns. For fall fumigation, 1,3-D is applied several months before planting. 1,3-D either
volatilizes, leaches below the root zone, or breaks down in the soil, and thus is generally not
available for uptake.
Dow AgroSciences has indicated interest in at- and post-plant applications of 1,3-D to
orchard crops and grapevines. Before acting on these registrations, the Agency will require data
on whether there are residues in treated crops and whether tolerances, or exemptions from the
requirement of a tolerance, will be needed to support these uses.
Exposure through Water. Based on ground water monitoring, the Agency has
concluded there can be dietary exposure to 1,3-D through contaminated ground water. 1,3-D is
mobile, and in some areas, persistent, though these properties vary according to environmental
conditions such as temperature, soil type and soil porosity.
There are numerous ground water data bases available to the Agency, including a survey
of EPA's own monitoring, the USGS NAWQA Program and state data. The best information for
assessing human health impacts are two prospective ground water monitoring studies conducted
''.'.''" ' 83 ' . ' .-
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lifetime risks. "Dow AgroSciences is also conducting tap water monitoring in Michigan and
Connecticut to confirm that the label prohibition to be added as of August L, 1999 covers all
vulnerable cold environments. "
EPA is, also aware of other data bases which show only a few detects out of tens of
thousands of samples nationwide. The NAWQA sampling showed no detections of 1,3-D out of
21 study units, the locations of which coincide with some of the counties with heaviest 1,3-D use.
The main weakness in interpreting these data is that there is no information .in the summary
reports to determine whether 1,3-D was used in proximity of tested wells. A second weakness is
that NAWQA did not test for the presence of the two degradates of toxicological concern
(3-chloroacrylic acid and 3-chloroallyl alcohol). Nonetheless, the NAWQA summary reports do
provide a qualitative sense that 1,3-D use does not result in widespread aquifer contamination.
-In summary, the Agency believes it has mitigated risks in the most vulnerable areas and is
focusing resources now on developing confirmatory data in additional areas of high 1,3-D use.
All 1,3-D labels bear a ground water advisory to alert users to ground water contamination risk
and as of August 1, 1999, there will be a 100 foot buffer between drinking water wells and treated
fields. Although the buffer is expected to provide some protection to drinking water, the actual
mitigation on a site-by-site basis cannot be quantified since this will depend on a variety of local
factors (such as soil type, subsurface hydrogeology, etc.). The tap water monitoring will be
designed to allow EPA to take further regulatory action if study results indicate a problem. EPA
is also committed to following trends in usage should 1,3-D use increase significantly, especially
in areas which may be vulnerable.
(ii) Residential Exposure
The Agency has determined that exposures and risk to residents who live near 1,3-D-
treated fields has been mitigated to the extent feasible. Data developed for reregistration and the
Special Review show that about 25 percent of applied 1,3-D volatilizes from treated soils into the
atmosphere and that atmospheric levels decrease with increasing distance from treated fields.
These studies were less clear as to the value of a variety of measures added to 1,3-D labels.
In 1994, 1,3-D labels were modified to add a 300 foot buffer between occupied structures
and treated fields. Three air monitoring studies in different environments show an approximate 30
percent overall reduction in air levels at this distance, however, the amount varied by site. In
addition, there are label measures designed to minimize the amount of 1,3-D that volatilizes out of
treated fields, such as soil sealing, engineering controls for loading and application and lowered
rates. As mentioned, above, the risk reduction value of several of these measures cannot be
quantified with the data available, and-would be difficult to obtain based on numerous
uncontrollable variables that ultimately influence exposure to 1,3-D.
In addition to not including (in a quantitative sense) all mitigation measures, there are also
uncertainties related to the data used to derive the residential exposure estimates. For example,
although levels are generally expected to decrease with increasing distance, at the Washington
85
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II I I'l
I11, I'jliiijii i i III j , |L ' |ซ II
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site, levels at 125 meters were approximately 70% higher than at 25 meters (see Table 8).
Although the studies were carefully designed to assess actual exposures, the variety and influence
of local environmental factors (such as wind, soil type, temperature) were quite large. These
factors not only varied from test site to test site, but even day by day at the individual test sites.
In addition, the small number of replicates per site are likely to have contributed to the mixed
results. The assessment also assumes that a person is 300 feet from the edge of the field for 16
hours a day, 15 days a year for 30 years. EPA believes it is reasonable to use this as a "worst-
Case"exposure scenario, though this is likely to overstate most residents' exposure.
In addition, a weakness in the residential exposure assessment is in the use of theNorth
Carolina data using 55-gallon drums of Telone C-17. While a later study using the mini-bulk
system was used to replace the worker exposures, that study could not be used for residential .
exposure assessment The N.C. data was combined with the Washington state and Arizona data
to get an average exposure, so the contribution of the N.C. values is expected to overstate
exposures because of the higher air levels associated with drum loading.
llililll i I < i "I h i i n'li'i " I:,,:.- ,, i1 !"'.'.'<'.'ii,
ow AgroSciences has indicated interest in developing systems that apply 1,3-D at sub-
suiface soil depths, instead of at the 12 inch depth required by current labels. The Agency believes
that this new method could provide lower exposures since the delivery system would not leave a
chisel trace. This chisel trace is thought to be the main path for 1,3-D movement to the
atmosphere. The Agency will require air monitoring with any registration application which
requests depth of application of less than 12 inches.
There are no residential uses of 1,3-D; thus, there is no exposure from home-based
applications.
(Hi) Aggregate and Cumulative Risks
The calculated drinking water risk estimates using 1,3-D labels eligible for reriegistration is
4 x 10"^ (using on-site wells from tiie Florida study); the inhalation risk is 6 x 10"6 (using an
'' ' ,:i"||v|rageof levelFmpiS ^tes'^tiiieSOO1'buffer).thus the ' :" ''
calculated aggregate risk estimate is 1 x l6"s. this risk estimate does not take into account
mitigation from lower application rates, soil sealing measures, increased depth of application, soil
moisture and temperature requirements or potential reduction in exposure from the 100 foot
. L^nnldng water well setback. EPA believes the risk estimates are likely to be in the 10"6 range and
[that riski concerns i have been addressed, when3!!of the mitigation measures as specified in this
I pregistration decision are taken into account. The Agency has not cumulated risks with the
' Impurity 1,2-D or other chemicals since no determination has been made that these chemicals
share a common mode of toxicity.
I ., ,, , i. , , , ^:,"wi:i i , i (iv) OccuPationaI ExPฐsure ^ '
j-Evi;-*;T!thง 'Agency'has deterrmned" mat 'existing jabel measures are sufficient to mitigate worker
I , , .,,,, : ,r ,., , *'||tpbsufe's to" 1,335. severฃ[ iabei changes have been made since the 1986 Registration Standard,
KjlliiihllR ' i'1' i.'!:1', if', ' ,' ML!: I!' " ' J1 '""' ! 'i "i1 ' ""i,. ' "' ';"ปiill!iii I'' !"" ""li"1',,,1 'n,,1 " ,J,!,''1|1"! '1ฐ "if'i "Hllll'il"1"' "'nป',|.,: , 'A ! ป "i ' ''i',,"'i "' ' '!"'., i1'!,.!,1 : !i.,' ',ป :l" ii'1,, " sit' ปi ป'.,.' It'.' ' , , . ' . < / , ; ' :;,,
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including closed loading systems, engineering controls to prevent 1,3-D spillage at row-turns, the
' phase-out of drum delivery, respiratory requirements, the use of closed cabs, increasing the
restricted entry interval from three to five days and protective clothing.
While the data developed for estimating worker risks is of high quality, there are
uncertainties. From Table 7, the studies used to test the efficacy of dry disconnects (shut-off
valves for closed loading systems) gave mixed results, even suggesting that exposures were higher
with the dry disconnects. Another uncertainty is assessing the potential risk to workers based on
the methyl bromide phase-out Increased 1,3-D risks would occur if a worker who currently
applies methyl bromide replaces that methyl bromide use with 1,3-D. Based on conversations
with grower groups and the registrant, this is unlikely since there is very little, if any, tandem,use
of the two fumigants. The phase-out of methyl bromide will likely increase the numbers of
workers who are exposed to 1,3-D, but will not likely increase the lifetime cancer risk of an
individual worker.
According to data developed for the Special Review and reregistration, the risks for
custom applicators, custom loaders and for growers (who are assumed to both load and apply
- 1,3-D) is in the 10'5 to W6 range. Note that 1,3-D is a restricted use pesticide based on cancer
concerns for worker risks. Because of this there are certain training and reporting requirements.
The 1,3-D product stewardship goes beyond this training to provide manuals, videos and technical
support in the field.
EPA's policy on worker risk sets a goal of no greater than 10'6 lifetime risks for workers.
If, however, there are not measures available to do so, then risks that are somewhat higher will be
considered acceptable. Risks that are higher than 1CT4 are generally not seen as acceptable unless
extremely high benefits of the use of the pesticide outweigh these risks. '
In summary, the Agency believes that worker risks have been adequately mitigated with .
current label measures and are in accordance with current worker risk policies. The Agency's
determination takes into account expected increases in usage of 1,3-D with the methyl bromide
phase out.
b. Environmental/Ecological Effects
The Agency, believes that use of 1,3-D as specified in this document will not pose
unreasonable risks to the environment. However, certain properties of 1,3-D and its degradates
justify the on-going monitoring program underway to confirm this position.
Specifically, 1,3-D and its degradates have been detected in both retrospective and
prospective ground water monitoring studies. 1,3-D is considered mobile and persistent, with " -
these properties varying depending on environmental conditions. Studies show that the rate of
1,3-D degradation is proportional to temperature, and thus 1,3-D is expected to be more
persistent in colder environments. Limited data suggest that the degradates of 1,3-D, in particular
3-chloroacrylic acid, are more persistent than 1,3-D and the influence of temperature on
87
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rf'i. .
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persistence is less than for the parent. For this reason, the registrant is generating data on the
toxicity and environmental fate of the degradates. For this RED, the Agency has assumed that the
degradates* toxicity and exposure parameters are equal to the parent; this is considered a
conservative estimate.
Tne results of the prospective studies and information developed by USGS demonstrate
itjh'i'i'ji, i "i!|iป i|ir'i ii; ,,1,11,1;,, I,,, jig,,!1, i, |ii'||i|,,'h,i, i i|, i if , jiiin, ',|| jn Hiiiiiii' "I!1;;1,1"' I1', ' ; ii|i" *, , ,M 7- ,, , m, ,,, , , , , , , , ,
::,::. that lj3-D levels in gound water decrease with increasing distance from treated fields. The
^_i .^.- ^ >y..ffij^Qg'f^ftftao 2e|e^-ons ofljs-l) in any of its" 21 pn"aJs"e""|' monitoring study units around the
SM^* suggesting thai: 1,3-D does not pose a widespread contamination risk to aquifers.
Rather, the Agency believes the highest risks to the environment are in localized areas close to
!!M U'l'i * ' : ilili"! ll''''l'!"|!!'ii!lll!!' 'if *"* * , ''">.
Bested fields. The label statement to prohibit use in areas similar to the Wisconsin study site (i.e.,
cold climates with shallow ground water and permeable soils) is expected to lessen the potential
:i | .si,;,, for environmental risk as well as risks to human heaWh.
,' ' i
|&JiHNi ;;,' |,|;;i |: ;f |or ^og^^^ T<3Ai indicate that 1,3-D is'' '"""
sjightly toxic on an acute oral basis to small mammals, moderately toxic on an acute oral basis to
girds, moderately toxic to acutely toxic to freshwater fish and bees, and very highly toxic to
.5!;-; ":!,;;; '|r^water i^ertebrates." rToJdcity testing has not"Been conducted on estuarine or marine
j :$";'' '.* ,งrganisms.
j/iibi'ii '; , liiiilU'ii''Jiii'1 ' 'i";i,,',:,,i'i,r!''i '.."i1 ' ,, i! it! ,,i"" ' T ''tii'i " "';',, M ,n ",; iv11ซ : ,,,i, .' ',":' iii,ป ,.' u, 'i,^ , "i:":!!>,!,:ป! \-' "V- ' | " , , " i ' , ' ,
Because 1,3-D degradation appears to be related to temperature, organisms living in
cooler climates (where degradation is slower) would be at greater risk than those in warm
climates. Applications to cool climate crops may pose the greatest acute and chronic risks.
Intuitively, although use in Florida may present a substantial risk to freshwater and estuarine
organisms, the potential for chronic effectsi maybe^shortened Because of the rapid degradation in
warm climates.
1,3-D application methods (soil injection and subsurface drip irrigation) greatly reduce the
risk to terrestrial birds. Since application is primarily to bare fields prior to planting,'terrestrial
organisms could be at risk through three routes of exposure: ingestion of contaminated soil,
ingestion of contaminated water or inhalation of 1,3-D vapors.
Birds. Soil residue levels found in field samples were used to estimate risk to birds.
/Vcute risk quotients did not exceed any LOG even at the maximum application rates. No data are
available to conduct a chronic risk assessment. However, given the relatively short field
dissipation half-life, chronic exposure is not anticipated.
Mammals. Using soil and air concentrations from field studies, acute risk quotients did
mi ii i 7 MI iiiiiii i ฐ ,, ,'. , , ,. *. i
UPl exceed any LOG. These results indicate the use of 1,3-D should not result m significant acute
mortality to mammalian species via dietary or inhalation exposure under any application scenario.
The chronic LOG was not exceeded based on reproductive effects data. It was exceeded slightly
in a ra| feeding study, but given 1,3-D's relatively short dissipation half-life and one application
per year, EPA does not expect cfironic effects.
5;i' " : I " (- ,' /!V ' ' IJ 'ill i "i ' : - ,i,r ' ': : s' V: '.ซ "- '*' 1(< "t\,. I- - 'ฃ '"3 *'; i i ,. l:":',',;.,,,,. ,i',' ;: i i .:.!:: *,
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88
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Aquatic Organisms. Using GENEEC information, application rates, equal evaluated (at
or above 177 Ibs. a.i. per acre) exceed the acute high risk LOC's for freshwater fish and
freshwater invertebrates. Using measured residues found in ditch water adjacent to treated fields
at 182 Ibs. ai/acre, the LOG for endangered species was exceeded. Concentrations in four foot
deep ground water in Florida were higher than the LOG for aquatic invertebrates. No data were
available to assess chronic risk.
It should be noted again that the computer model GENEEC is a screening model designed
only to help determine if substantial risks are unlikely. It should not be used to determine if
substantial risks are likely. The determination of whether risks actually exceed the LOC's depends
on data generated from higher-tier exposure-and risk assessments and/or additional monitoring
information. ,
Estuarine and Marine Organisms. No estuarine or marine toxicity data were required
for refegistration in the 1986 Registration Standard, and as such, no acute or chronic risk analysis
could be conducted. The registrant is generating acute data for estuarine and marine organisms
since 1,3-D use is expected to expand to these areas. ,
Plants. No toxicity information for non-target plants has been submitted. Consequently
no risk analysis has beenfconducted. However, 1,3-D is registered as a herbicide and has
phytotoxicity warnings and, therefore, is a candidate for both terrestrial and aquatic plant testing.
c. Restricted Use Classification '
Based on 1,3-D's high aqute inhalation toxicity, potential carcinogenicity and its use
patterns, the Agency is maintaining the Restricted Use classification for all 1,3-D products that
are currently so classified.
d. Endangered Species Statement
The Agency has developed a program (the "Endangered Species Protection Program") to
identify pesticides which may cause adverse impacts.on endangered and threatened species, and to
implement mitigation measures that will eliminate the adverse impacts. At present, the program is
being implemented on an interim basis as described in a Federal Register notice (54 FR 27984-
28008, July 3, 1989), and is providing information to pesticide users to help them protect these
species on a voluntary basis. As currently planned, the final program will call for label
modifications referring to required limitations on pesticide .uses, typically as depicted in county-
specific bulletins or by other site-specific mechanism as specified by state partners. A final
program, which may be altered from the interim program, will be described in a future Federal
Register notice. The Agency is not imposing label modifications through this RED. Rather, any
requirements for product use modifications will occur in the future under the Endangered Species
Protection Program.
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Ill I
ill 1
eV Labeling Rationale
The Agency is maintaining its current label restrictions and is basing its reregistration
decision on these measures and other label measures that will be added as of
August 1, 1999. There are on-going studies, reviews and data collection which are being
conducted to confirm the Agency's position that 1,3-D, when used as specified in this document,
3j|pes not pose unreasonable adverse effects to humans or the environment. Should the results of
s;'^^~' ::; v'Aojecoiffinnatory data provide information to change the Agency's current risk assessment and
'KrJSK^^/T* ''position, EPA will consider further label changes to maintain the registration of products'
(i) Labeling Requirements for Handlers (Including Re-Entry)
~'i-::;;.:'":'The 1992 Worker Protection Standard for Agricultural Pesticides (WPS) and changes to
IIIIIIHil" ,;h i ii",i!i'"l,,;!l! .,ii!":i;!i!llll'l,i, ' ,,!!'> i MlllH!111!' V ,:ป: "II '''ill!1! llflll (' ป' ,i ซ . II., J"!!!, , MlliliP '!! 'I "iM"' ! I 'I1'1' ' I! IIIHI'' I" i"'' I 111 I II I I I III Ir I I I ^ . J/n . .,
|,3-D labels in 1992 and 1996 established worker protection requirements to be specified on the
^1ป* *.'''*'!; Jal.fl, o|3f Pro^uc% ^aj- contain uses, T^!;!1?11 me scฐPe ^,e WPง- ^s?s, w^1^n, *^e scฐPe ฐf the
:i , =, :.::. -WPS include 'M cpmmercid^n-homepwner) and research uses on farms, forests, nurseries and
i;;;*j:' l^'1 ^^Sliousies to'"'prpduce agricultural' plante"^nclud|mg food, feed a^dfiW plants, trees, turf grass,
*pซป, 'If''1;'"' 'j.flp^ej^.|ihrubiSj ornamentals and seedlingsj. Uses within the scpge included not only uses on
ikjljf.i;-'" ; fpianfs but also uses on the soil or planting medium the plants are (or will be) grown in.
The Personal Protective Equipment (PPE) requirements under the WPS, as well as the
process for complying with the WPS are found in PR notice 93-7. For products containing 1,3-D,
a supplement, entitled, "Supplement Four-D, Labeling Guidance for 1,3-Dichloropropene
Fumigant Products" was issued with specific working for all 1,3-D product labels. A separate
supplement, "Supplement Four-E, Labeiing guidance for 1,3-Dichloropropene Plus Chlofopicrin
Fumigant Products" was also issued.. Some of the PPE requirements in the WPS were further
refined in 1995. The requirements for 1,3-D handlers are specified below (note these are
requirements for 1,3-D only): - ,
I I Illlll I I I Illlllllllll I I |!!,fl"li! I ailH',,;,! ป.,:' &^ llCl!l.'"'IJi'iii,, 'i;11'!111!1!::,1!1'. ,.!'!ป *'\ 'v.lFlli'11"11!1!1 i'*!!!'",:**1!,,*!'1 J'. ,,,i! '!,,";!lli;, ," 'i1/!,"1!! ""It:,!,1 i'h! ".Wii'lfl,'" ' I1 ',',..' ,',', 'i , H'^, ,h", '!,:, :'.' '";
i1 HanSlers Pe|^rming Direct"Contact" Tasks '(e.g., "includes 'equipment repair and
calibration^ fiimigant transfers, clean-up of small spills) -,
- Coveralls over short-sleeved shirt and short pants,
- dhemical-resistant gloves (barrier laminate (EVAL) or viton)
- Chemical^ resistant footwear^ plus socks^
- Face-sealing goggles, unless full face respirator is worn
= Chemical resistant headgear for overhead exposure
- Chemical-resistant apron
- Respirator with organic-vapor-removing cartridge or canister approved for pesticides
Handlers in Enclosed Cabs ' ' _
- Coveralls
r-Shoes and socks
90
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- A half-face respirator with an organic-vapof-rernoving cartridge or canister approved for
pesticides
- A respirator is NOT required if occupants are within an enclosed cab equipped with a
vapor-adsorptive filter (activated charcoal). HOWEVER, PPE for direct handlers must be
worn if applicator within cab leaves the cab and re-enters.
Post Application/Re-entry Handlers in Treated Area within REI - Five Days after
Application ,
- Coveralls ,
- Chemical-resistant gloves (barrier laminate (EVAL) or viton) ,
- Chemical-resistant footwear and socks
- Respirator with organic-vapor-removing cartridge or canister approved for pesticides
Handlers Exposed to High Concentrations (e.g., clean-up of large spills)
- Chemical resistant suit .
- Chemical resistant gloves (barrier laminate (EVAL) or viton)
- Chemical-resistant footwear plus socks
- Chemical-resistant headgear
- Supplied air respirator
The Agency is retaining the WPS requirements, as well as all other PPE and engineering
controls which are as follows:
Table 27. Summary of 1,3-D Label Restrictions that Affect Worker Exposures
Regulatory Action '
(effective date)
Registration Standard
. (1986)
, 1992 Label Amendments
(1992/1993)
Worker Protection Standard
(August 1992
see 57 FR 38102)
1995 Label Amendments
(1996) .
Label Requirements '
Precautionary Statements; Cancer Hazard Warning; Classification
Change to Restricted Use Pesticide; Reentry increased to 72 Hours*;
Clothing for Applicators and Handlers (Coveralls*, Chemical-resistant ,
Gloves and Boots, Liquid-proof hat).
Lowered Maximum rates; Deletion of Selected Use Sites; Revised
Respirator Requirements*; Closed Loading Requirements; Technology
to Minimize 1,3-D Spillage during Application, Improved Product
Stewardship Materials
Coveralls over short-sleeved shirt and short pants; Chemical-resistant
gloves and footwear; Chemical-resistant Apron (for direct handlers).
A Respirator Requirement for all 1,3-D handlers (except those in certain
closed cabs); Restricted Entry increased to 5 days; Soil moisture and
soil sealing requirements; Modified application techniques and Lower
maximum use rates.
- measures which were superceded or modified by subsequent label changes
91
-------
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(ii) Labeling Requirements that Affect Residential Exposure
There are no residential uses of 1,3-D. However, the Agency has concerns for inhalation
risks to residents who live near 1,3-D treated fields, and an additional concern for residents who
Illlll!,!:'1!':1};!!11! Hi:',11 II II II III Illllll II I I I II I ' ' ,i , i,i, !,,, , -I,,,,. , , , i' ,,,,',
Obtain drinking water from private wells in the proximity of treated fields.
1 ' !1 - ;'
i IN, i; i1"],!.1!!11;1,,!;!1,, , nซii.';|!f|
ing water from private wells in the proximity
kR^in the 1986 Registration Standard. In 1990, California
,'''งus|je:rMed 1,3-D use permits based on unexpectedly high levels of 1,3-D in the atmosphere
"" jfollowing treatment EPA used the Sgecial Review process to obtain additional data and risk
rhitigaSon (througn label amendments) to mitigate inhalation exposures.
EPA is also retaining requirements for measures to mitigate risks from exposure through
i 'Jim | ป ,,]:'| ,i ' I'^'iii'i'iLI',!,: a,1'I'""!!! ,: !li ilUIIiu 'Mi,1**'"!""11 n li,,,: , ,iiM!rr",i" r -l!j , ',i;.* .si": "nft ii"i;-s;; r > !<ฑ-aflipuwiwi'>(**,1 t:;Kt'j w.-i&'ws ;*,
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Because the end-use product Telone n is also reformulated into other products, EPA is
requiring that any product containing 1,3-D bear a label statement to require that all measures on
|hei;iiTel:gneJabel are also required on any other productTContaining 1,3-D. This measure is
Sgsigned to cover all reformulated products, whether the 1,3^D source is Dow A^roStience's
Telone product or from some other producer or reformulator.
Ivil'lHl;;'',' iiLiiii ad1!1 :"ii;:,Ir -T .
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V. ACTIONS REQUIRED OF REGISTRANTS
*
A. Amendments to Current 1,3-D Registrations
This section specifies the data requirements and responses necessary for the reregistration
of products containing 1,3-D.
B. Requirements for 1,3-D Products
1. Additional Generic Data Requirements
On September 30, 1998, Dow AgroSciences requested changes to the terms and
conditions of their 1,3-D registrations to include modified labels and study requirements (Roby
1998). All 1,3-D products must be relabeled by August 1, 1999 to include the amended labeling.
In addition to the label changes, the registrant has agreed to conduct the following studies:
a. Studies to be performed as a result of modified terms and
conditions of registration - Studies on 3-chIoroacryIic acid
, and 3-chloroalIyI alcohol
Table 29 - Study on 3-chlorbaciylic
acid and 2-chloroallyl alcohol
Acute oral-rat
Acute dermal toxicity - rabbit/rat
Primary eye irritation - rabbit
Primary dermal irritation
dermal sensitization
mutagenicity (Ames assay)
mouse micronucleus
pharmacokinetics/balance of
metabolism
mouse lymphoma
in vitro chromosomal aberration in
Chinese Hamster lung
developmental toxicology
subchronic 90-day feeding study
aquatic aerobic metabolism
OPP Guideline
Number
81-1
81-2
81-4
81-5
81-6
84-2A
84-2
85-1
84-2
84-2
83-3A
82-1A
162-4
Study Due Date
June 1, 1999
June 1, 1999
June 1, 1999
June 1, 1999
June 1, 1999
October 1, 1999
October 1, 1999
October 1, 2000
October 1, 1999
October!, 1999
January 1, 2000
January 1, 2000
October 1, 1999
93
-------
i; "if .ft,'5
.: ': ft 11'.'
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Table 29 - Study on 3-chloroacrylic
acid and 2-chloroallyl alcohol
adsorption/desorption
hydrolysis
vapor pressure
Henry's Law Constant
acute fish toxicity- rainbow trout
acute aquatic invertebrate toxicity-
Daphnia magna
Tier I and Tier II aquatic plant
OPP Guideline
Number
163-1
161-1
68-9
NA
72-1
72-2(a)
122-2/123-2
Study Due Date
October 1, 1999
October 1, 1999
October 1, 1999
October 1, 1999
June 1, 1999
June 1, 1999
June 1, 1999
1 't liliil;!1 iiiilii1
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b.
Studies to be performed as a result of modified terms and
conditions of registration - 1,3-D
Table 30 - Study on 1,3-D
Freshwater fish early life stage -
rainbow trout
Freshwater aquatic invertebrate life
cycle - Daphnia magna
Estuarine/marine fish LC 50-
sheepshead minnow
Estuarine/marine invertebrate
LCSO-mysid shrimp
Estuarine/marine invetebrate
LC50-eastern oyster
Tier I and Tier II aquatic plant
Seed germination and seedling
emergence
Vegetative vigor
Tier I and Tier II terrestrial plants
Aerobic aquatic metabolism
Guideline Number
72-4(a)
72-4(b)
72-3(a)
72-3(b)
72-3(b)
122-2/123-2
122-l(a)
122-l(b)
122-1 and 123-1
162-4
Due Date
October 1, 1999
October 1, 1999
June 1, 1999
June 1, 1999
June 1, 1999
June 1, 1999
October 1, 1999
October 1, 1999
October 1, 2000
October 1, 1999
11,'iiiM i' " t i mil,
94
-------
c. Studies to be performed as a result of modified terms and
conditions of registration with tiered requirements - Run-off
Study and Studies on Ecotoxicity
Dow AgroSciences will conduct a run-off study to assess whether run-off is a significant
pathway for movement of 1,3-D in the environment If studies show that 1,3-D and/or its
degradates can enter surface water in unacceptably high amounts as a result of run-off, then the
battery of studies for 3-chloroacrylic acid and 3-chloroallyl alcohol for estuarine/marine animals
(sheepshead minnow, mysid shrimp, eastern oyster) will be required.
In addition, EPA may require an avian acute oral study on the degradates pending the
results of the environmental fate studies on the degradates. As noted in section E.4.C., the
application method, of 1,3-D is not expected to result in high exposures to birds. If, however, the
environmental fate study results show that concentrations of concern may be present, then EPA
will require an acute avian oral study.
d. Product Chemistry Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
not, commit to conduct new studies.. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the instructions
in the Requirement Status and Registrants Response Form provided for each product. The
product-specific data requirements are listed in Appendix D, "Product Specific Data Call-in."
2. Formulation Changes
\ - ''-
There are no requirements for formulation changes to products containing 1,3-D at this
time.
3. Time frames
Revised labeling is scheduled to be borne by all products by August 1, 1999. The time
frames for the additional studies are listed in the Tables 29 and 3 0 above.
4. Labeling Requirements for End-Use Products
All end-use products should have clear, concise and complete labeling instructions.
Proper labels can improve reader understanding, thereby reducing misuse and the potential for
incidents. Towards this end, the Agency is requiring the following:
95
-------
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t apply within 100 feet of any well used for potable wat
t apply in areas overlying karst geology."
llowing restriction applies only in North Dakota, South
ota, New York, Maine, New Hampshire, Vermont, Mai
ia:
Where ground water aquifers exist at a depth of 50 feet
not apply this product where soils are Hydrologlc Grou
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C. Existing Stocks
The existing stocks time frames have been set for products containing 1,3-D.. The label changes
which are referred to above in Table 32 are to be on all products which are sold or distributed by Dow
AgroSciences or any reformulator by August 1, 1999.
97
-------
,
98
-------
VI. APPENDICES
99
-------
IN1'
Appendix A - Table of Use Patterns Subj ect to this RED
Appendix A is 23 pages long and is not being included in this RED. Copies of Appendix A are
available upon request per the instructions in Appendix E.
in I
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100
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case 0328 covered by this Reregistration Eligibility Decision Document. It'
. contains generic data requirements that apply to 0328 in all products, including data requirements for
which a "typical formulation", is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158, The reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements
apply. The following letter designations are used for the given use patterns:
A Terrestrial food '
B Terrestrial feed
C- Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry , "
K Residential .. .
L Indoor food
M Indoor non-food
N Indoor medical
6 Indoor residential
3: Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists
the identifying number of each study. This normally is the Master Record Identification (MRID)
number, but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography
appendix for a complete citation of the study.
101
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GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study"! In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct '
title (or at least a single subj ect), can stand alone'for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique to
the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs. .
a.
b.
Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced the
date from the evidence contained in the document. When the date appears as
111
-------
'I:!!'!111' fill!:1 ! IIIllllll
IiW !i!l!ill,"':<: . ilii!'
IIHfiir 1' Ilil
IiillliiM; iil'S! , !;,.
SfTSI(fl|ViCTi!iWI .
??), the Agency was unable to determine or estimate the date of the
..;, C.
I!" lit
t*
Title. In some cases, it has been necessary for the Agency bibliographers to
,:j5M||te or enhance a document title. Any such editorial insertions are contained
oet^
lit!:!1' M , /I!;1! d'
II filrfc: i
Killer IR
JlBiljijik., '! .ill. .1 ii
iiiiiR'i'i' 'ii::. >
II
Submission date. The date of the earliest known submission appears
immediately following the word "received."
Administrative number. The next element immediately following the
:|:;'f;ir'IMbfd "under" is the registration number, experimental use permit
itunber, petition number, or other administrative number associated with
the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix-which shows the relative position of the study within
the volume.
112
-------
MRID
BIBLIOGRAPHY
CITATION
Table 1 - Citations with MRTO Numbers Assigned
00030385
00033255
00033256
00033257
00033258
00033259
00033260
Glas, R.D. (1979) Determination of Residues of Cisand Trans
l,3Dichloropropene in Plant Materials: ACR 79.15: Method dated NoV 30,
1979. (Unpublished study received Feb 7,1980 under 464511; submitted by
Dow Chemical U.S.A., Midland, Mich.; CDL: 241761-B)
McKinney, W.J.; Wendt, M.B.; Abbott, R.; et al. (1978) [Residues in
Sugarbeets]: TIR-24-3 55-76. (Unpublished study including TIR24-355-76-B,
received Jun 25, 1980 under 464-511; prepared by Shell Development Co., .
submitted by Dow Chemical U.S:A., Midland, Mich.; CDL:242726-A)
McKinney, W.J.; Wendt, M.B.; Fries, F.A.; et al. (1978) [Residues in Cabbage]:
TIR-24-160-78-A. (Unpublished study including HR24-195-78B and
TJJR.-24-195-78, received Jun 25, 1980 under 464511; prepared by Shell
Development Co., submitted by Dow Chemical U.S.A., Midland Mich
CDL:242726-B) '
McKinney, W.J.; Wendt, M.B. (1978) [Residues in Potatoes]: TIR-24172-78-A.
(Unpublished study including TJJR.-24-172-78-B, received Jun 25, 1980 under
464-511; prepared by Shell Development Co., submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL: 242726-C)
McKinney, W.J.; Fries, F.A.; Wendt, M.B.; et al. (1978) [Residues in
Cauliflower]: TIR-24-180-78. (Unpublished study including TIR-24-180-78-B,
received Jun 25, 1980 under 464-511; prepared by Shell Development Co.,
submitted by Dow Chemical U.S.A^, Midland, Mich.; CDL:242726-D)
McKinney, W.J.; Fries, F.A.; Wendt, M.B.; et al. (1978) [Residues in Lettuce]:
TIR-24-191-78A. (Unpublished study including TIR24-191-78-B,
TIR-24-192-78A and TTR.-24-192-78-B, received Jun 25, 1980 under 464-511;
prepared by Shell Development Co., submitted by Dow Chemical U.S.A.,
Midland, Mich.; CDL:242726-E)
McKinney, W.J.; Fries, F.A.; Bierman, B.; et al. (1979) [Residues in
Watermelon]: TIR-24-227-78B. (Unpublished study including TIR-24-227-78,
TIR-24-244-78-B and TTR-24-244-78, received Jun 25, 1980 under 464-511;
113
-------
BIBLIOGRAPHY
MRID
CITATION
00039685
00039688
00039692
00039693
00039694
00039695
00039696
Experimental Medical Research Institute Co., Ltd., submitted by Dow Chemical -
U.SA., Midland, Mich.; CDL:099515-J)
Coate, W.B.; Keenan, D.L.; Hardy, R.J.; et al. (1978) Final Report: TeloneA(R)=
H (Production Grade): Project No:. 174-126. (Unpublished study received Jul
22, 1980 under 464-EX-63; prepared by Hazleton Laboratories America, Inc.,
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:099515-L)
Sudo, S.; Nakazawa, M.; Nakazono, M.; et al. (1978) The Mutagenrcity Test on
1,3-Dichloropropene in Bacteria Test System: Project No. NRI-78r2819.
(Unpublished study received Jul 22, 1980 under 464-EX-63; prepared by
Nomura Sogo Research Institute, submitted by Dow Chemical U S A Midland
Mich.; CDL:099515-P)
Bentley, R.E. (1975) Acute toxichy of M-3993 to Bluegill (n~Lepomis
macrochirus~u) and Rainbow Tfout (p.~Salmo gairdu~neri~u). (Unpublished
study received Jul 22, 1980 under 464EX-63; prepared by Bionomics, EG&G,
submitted by Dow Chemical U.S.A., Midland, Mich.; CDL;099515-T)
Dow Chemical U.S:A. (19??) Summary of Residue Analyses of
1,3-Dichloropropenes in Crops Treated Post-plant with Telone it. (Unpublished
study received Jul 22, 1980 under 464-EX-63; CDL: 099515-W)
Glas, R.D. (1980) Determination of Resudies [sic] of Cisand
Transl,3-Dichloropropene in Fruit: ACR 80.9. Method dated Jul 9, 1980.
(Unpublished study received Jul 22, 1980 under 464-EX63; submitted by Dow
Chemical U.S.A., Midland, Mich.; CDL: 099515-X)
Glas, R.D. (1980) Determination of Residues of Cisand TransChloroallyl
Alcohols in Fruit by Gas Chromatography Using and Electrolytic Conductivity
Detector: ACR 80.10. Method dated Jul 9, 1980. (Unpublished study received
Jul 22, 1980 under 464-EX63; submitted by Dow Chemical U.S.A Midland
Mich.; CDL: 099515-Y)
Lembright, H.W.; Hart, W.; Rough, D. (1980) Residues of
1,3-Dichloropropenes and Chloroallyl Alcohols in Green Almonds Grown in Soil
Fumigated with Telone JJ Soil Fumigant. (Unpublished study received Jul 22,
115
-------
BIBLIOGRAPHY
MRID
CITATION
00109291
00109420
00109672
00115214
00117045
00117050
00118938
Shell Development Co. (1981) Residue Determination of the Z and E Isomers of
3-chloroallyl Alcohol (CAA) in Agricultural Commodities, Soils, and Water:
Capillary GLC/Hall Electrolytic Conductivity Detector Method: MMS-R-506-2.
(Unpublished study received Jan 15, 1982 under 201-253; CDL:246671-A)
Shell Development Co. (1981) Residue Determination of 1,2-dichloropropane
and the Z and E Isomers of 1,3-dichloropropene in Agricultural Commodities,
Soil and Water: Capillary GLC/Hall Electrolytic Conductivity Detector Method:
MMS-R-505-2. (Unpublished study received Jan 15, 1982 under 201-253-
CDL: 246672-A) - '
Shell Chemical Co. (1978) D-D Crop Residue and Analytic Methods: Volume
JJJ. (Compilation; unpublished study received Aug 30, 1978 under 201-119-
CDL:235253-A)
Dow Chemical U.S.A, (1982) Residue Data, Where Pertinent, on (a) Food or
Feed Commodities; (b) Nonfood Crops Such as Tobacco; and (c) Foliage or
Other Sites Which May Relate to Worker Hazard or Adverse Effects on the
Environment. Include a Description of the Analytical Method(s) Used and a
Summary of the Data. (Compilation; unpublished study received Sep 22, 1982
under 464-EX63; CDL:248406-B)
Dow Chemical U.S.A. (1982) [Telone H Chemistry Data]. (Compilation;
unpublished study received Sep 22, 1982 under 464-EX-63; CDL:248416-A)
Meikle, R.; Youngson, C. (1980) The Hydrolysis Rates of cisand
trans-l,3-Dichloropropene, 1,2-Dichloropropane and 2,3-Dichloropropene in
Dilute Aqueous Solution: Report GS-1659. Final rept. (Unpublished study
received Sep 22,1982 under 464-EX-63; submitted by Dow Chemical USA
Midland, MI; CDL:248417-F)
Fink, R.; Beavers, J.; Joiner, G; et-aL (1982) Acute Oral LD50-Bobwhite Quail:
Telone H Soil Fumigant: Project No. 103-207. Final rept. (Unpublished study
received Sep 22, 1982 under 464-EX-63; prepared by Wildlife International Ltd.,
submitted by Dow Chemical U.S.A., Midland, MI; CDL:248415-C)
117
-------
BIBLIOGRAPHY
MRDD
CITATION
00144715 John, I; Kloes, P.; Calhoun, L.; et al. (1983) Telone E: Inhalation Teratology
Study in Fischer 344 Rats and New Zealand White Rabbits: Report No. HET
M-003993-006. Unpublished study prepared by Dow Chemical US A. 37 p.
00146461 Stott, W.; Young, I; Calhoun, L.; et al. (1984) Telone II Soil Fumigant: A
13-week Inhalation Study in Rats and Mice. Unpublished study prepared by
Dow Chemical U.S. A. 65 p.
1(11.1 Hit;: 11.;; ',' o8"l46467 '""""" "Mendrala,' A. (1985) 'Evaluation of Telone' E in tfie 1^'H^atocyte Unscheduled'"
DNA Synthesis Assay. Unpublished study by Dow Chemical U.S.A. 14 p.
|=;l;.' <58ft646^9 " '~ '"'^US, pfPjA^
"* ''' ;;:'"tf ''V;'l!:; ''-^ ;; M .$% j^icttbrohydnn'as" a"Stabffizer)inF344/NRatsand B6C3F1 Mice
;JSt :;-,, ' gji.ji-i.';:, f;;, f $.>.; jJGavage JStudies):']^Publication"'No. 85-2525! US'Government Printing "
.':;';;:;:* ":'"r",'" ,:! : -:":;; ' '"'Office;" 153 p. '' ' ' '
00152848 John, I; Kloes, P.; Calhoun, L.; et al. (1983) Telone E: Inhalation Teratology
";;;;;j; ;;pi ' *.; '", ,_'";;;; Study in Fischer 344 Rate and 1S1^ Zealand
, ,. ,- '; ::;E" :' , I","' :V.; , ":' ': : ':;'', unpublished study prepared by Dow Chemical U.iS.A.' 50 p.
iji1'!,'i|iMl|i !!llil!l!' " ''i1!'1 ! l!l'i ' ' ' !|"!'!!'i" ปn"f!1 " ' '' ''" ' s !| ' ' |'!i!|!,i|l! ./'i1' '''' lhl \ ' ji'1. "'f'tJiijiii'?ir " *";1;|i.|'!|!v",i'!,ป|irr.iliyi pj r ^ ." ,,-., TI;'! iiiv1'! ' '' '''ij, i'1'1"1'!1' ' vii11.;,1 '"!', - i .>-^ . ป :,
00155846 ^
;;;;:;;,; [ ; ;- "^ ;iih ;;::Pharmacoidnetics,,,,Efifect on. Tissue Non-protein Sulfhydryls, and
' '!!Maqromolecuiar Binding in Fischer-344 Rats and B6C3F1 Mice following Oral
,. , !"; t/|f;:; V" '|-i !'" " /:" ,: !!i'';^c^!n^istration. Unpublished study prepared by Dow Chemical U.S.A. 50 p.
00158442 'jMcCali, P. (ipggj Hydrolysis of l,3TDichioropropene in Dihrte Aqueous
;;i| i , |:'; ; i ซ, ;:;.;::; ^iolution:,GJEKH81.2,,.Unpublished study by Dow Chemical U.S.A. 17 p.
_ Ii;' i'.' -." * '.i: i, ป; /,"..;. iliiiii:,' I,;',;,; ! I":: ''>, = , ;i|i, t i; .'.' \t; I' (i'.'' && ifif i' w; il';': ;i ;. ! - &ซ iiV"ป;:if' ;-':!!'iv;-f iii f i..; ' ). ', '': '".;" , i .. i ,.' :
00159679 Mendrala, A. (1986) The Evaluation of Telone E Soil Fumigant in the Chinese
Hamster Ovary Cell/Hypoxanthine (Guanine) Phosphoribosyl Transferase
i Forward Mutation Assay. Unpublished study prepared by Dow
00 1 63030
.
Ldria, R.; Eplee, R.; Baier, I; et al. (1986) Efficacy of sweepshank fumigation
with 1,3-dichloropropene against Pratylenchus penetrants and subsequent
ground water contamination. Plant Disease 70(1) :42-45.
118
-------
BIBLIOGRAPHY
MRID
CITATION
00163031
00164143
40025901
40163301
40220901
40220902
40220903
40220904
40220905
Kotcon, J.; Loria, R. (1986) Fall Fumigation of Potato with
1,3-dichloropropene: Efficacy against Pratylenchus crenatus, Yield Response,
and Potential for Groundwater Contamination. Unpublished study prepared by
Cornell Univ., Long Island Horticultural Research Lab. 14 p.
Smith, S.; Kelly, I. (1986) Preliminary Report: MITC Derived Residues in
Tomatoes from Fumigated Soil: Study No. 73D: Report No. METAB/86/29.
Unpublished study prepared by Scheriiig Agrochemical Limited. 17 p.
McCall, P. (1986) Anaerobic Soil Degradation of 1, 3-Dichloropropene: Project
ID; Protocol No. 59-84. Unpublished study prepared by Dow Chemical U.S.A.
45 p. - - -. _ -
Wichman, K. (1987) Product Chemistry: Telone E Soil Fumigant. Unpublished
compilation prepared by Dow Chemical U.S.A. 30 p.
Jeffrey, M.; Baltics, I; Lamax, L.(1987) Telone ri Soil Fumigant: Acute Oral
Toxicity Study in Fischer 344 Rats: Laboratory Project ID: HET
M-003993-017A. Unpublished study prepared by Dow Chemical Co. 29 p.
Jeffrey, M.; Schuetz, D.; Lomax, L. (1987) Telone E Soil Fumigant: Acute
Dermal Toxicity Study in New Zealand White Rabbits: Laboratory Project ID:
HETM-003993-017D. Unpublished study prepared by Dow Chemical Co 25
p. , ' - ,. ~ '
Streeter, C.; Battjes, I- Lomax, L. (1987) Telone E Soil Fumigant: An Acute
Vapor Inhalation Study in Fischer 344 Rats: Laboratory Project ED: HET
M-003993-018. Unpublished study prepared by Dow, Chemical Co. 33 p.
Jeffrey, M. (1987) Telone E Soil Fumigant: Primary Eye Irritation Study in New
Zealand White Rabbits: Laboratory Proj ect E): HET M-003 993-017C.
Unpublished study prepared by. Dow Chemical Co. 9 p.
Jeffrey, M. (1987) Telone E Soil Fumigant: Primary DermafIrritation Study in
New Zealand White Rabbits: Laboratory Project E): HET M-003993-017B.
Unpublished study prepared by Dow Chemical Co.' 9 p.
119
-------
BIBLIOGRAPHY
iii 11
(lid
CITATION
IP IP
1 MI J iti
40220906
40312201
Jeffrey, M. (1987) Telone n Soil Fumigant: Dermal Sensitization Potential in the
Hartley Albino Guinea Pig: Laboratory Project ID: HET M-003993-017E.
Unpublished study prepared by Dow Chemical Co. 10 p.
-' .in1*: ; '.;.,; MI
40312300
Lomax, L.; Calhoun, L.; Stott, W.; et al. (1987) Telone H Soil Fumigant: 2-Year
Inhalation Chronic Toxicity-Oncogenicily Study in Rats: Laboratory Project
Study ID: M-003 993-009R. Unpublished study prepared by Dow Chemical Co.
' 739P" ' , ,.-, .'..,.. ...*,
Dow Chemical Co. (1987) Submission of Toxicity Data to Support the
Reregistration of Telone n Soil Fumigant Containing 1,3-dichloropropene as
Active Ingredient. Transmittal of one study.
f clone n son
Two-generation Inhalation Reproduction Study in Fischer 344 Rats: Lab. Proj.
'Study ID M-003 993_oj5. ........ io^p^i^g^ gtu(jy pj^jared by 'The Dow' Chemical
- .. . . . , , ,r ,
ง40390101 Fontaine, D.: Teeter, D. (1987) Vapor-phase Photodegradation of
.[Jilli j|i|l MfKiffill'(':" I .: ,4 "Ml';IWtli^'M A h11 * ' V ' r r ฐ ,
ijjiif 'li' rl';bi:i;iif}^:';,5it-'Ji:lll,3-Dichloropropene: Laboratory Project ID: GHC-1956. Unpublished study
prepared by Dow Chemical U.S.A. in cooperation with Analytical Bio-Chemistry
sii'sii;-1; ฃiฃ ;;ซi-' .iiiiir ^iii;;-;;;":;ซ:-"; i .^Laboratories, Inc. 25 p.
wSm J'"iv IIpl^lpl ,"," '. "IMcjmiiivK. (1987) Product Chemistry: Telone E Soil Fumigant: Lab. Prtoj. ID
' "1;1 iil;!YS^ Unpublished1 study prepared by Agricultural Chemistry
Laboratories. 16 p. ' .
iii;;;;; iSiisir vi':'.:' =|o463301 ' ''" Oliver^"" &: &{&$ฃ, E.:,' (S'SMa," R Tl986J Field Dissipation Study of Telone II
I! Hi I"!'!!)! ",:l.' II uYmi!: : I i'lli ' '' fl !> '"i! . IBllllll Ml1 "I li'1",*! " ?. J. f ?. N I r, '
:Sojl Fumigant: (Supplementary Information): Laboratory Project ID: GFJrC
' ClaemicaTU.S'.A'. 21 p. '
'" '
I iiijui'jiii iLiiiimiiiiiNkM is IP
'i i>i"Vi II"1 ill. ifWlllii1 H'M.:,1'! IL,',ป,'! Ilin1:"";1 ,XfM- ซW li^UIHiil:!! mim V "if l-l-riiilliT'iJ,iiBIII11!-'11 i,
riL';.^;'"^' oL" ;i;l9l?Il9l, .1,, Z!WsJ%9f^-T:"(l^^lS.^^^^!^ ฐf Water' Solubility of cis:l, ^ ' '
^3 Project ID: AL 87-76906. Unpublished study prepared by
;:*J"'*-.'' "-Analytical EaBoraiories. 13 p.
II *lllllll:'1!!illliaiinJfJI iilrll"'"I11 i! ''IIIINI:!!
llHiB.iiJS ' ' " JSiXII!!11:1" IJ'i ,i, "I,,,!!1, 1,"! : .. i1 ..... ,;." ' ,ii JHtiiiJ. "". iA!'! ,'',! ...... ii .."B1. "..i.1"1",1, MJILi i IIM 'Jllllll1 JI," JlUPlii lUiiri;!,., ..... l
....... ' .......... ' .................... ' .......... ......... ' ................. "": ............. .......... " ..... """"
3-Dichlororpropene: Project ID: AL 87-70907. Unpublished study prepared by
Dow Chemical USA. 13 p.
'-"lli.!'^^'"^^ ii::;i;::Ii'i'^ ' '"' '* ' ;"";i *'''' ^ " '"';"l'1":
-------
BIBLIOGRAPHY
MRID
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40483803
40483804
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40483806
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40571801
40571802
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40855501
40959801
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Project ID: ML-AL 87-40207,' Unpublished study prepared by Dow Chemical
Co. 7 p.
Karris, G.; Downey, J. (1987) Vapor Pressure of trans-l,3-Dichlorol-propene:
Project ID: ML-AL 87-40208. Unpublished study prepared by Dow Chemical
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of trans-l,3-Dichloropropene: Project ID: AL 87-70909. Unpublished study
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Bauriedel, W.; Miller, J. (1988) A Metabolism Study of Lettuce and Spinach
Grown in Soil Treated with [Carbon 14]-l,3-dichloropropenes: Project ID:
GH-C 2031. Unpublished study prepared by Dow Chemical U.S.A. 59 p.
1 ' '
Bauriedel, W.; Miller, J. (1988) A Metabolism Study of Soybeans Grown in Soil
Treated with [Carbon 14]-l,3-dichloroprbpenes: Project ID: GH-C 2032.
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Breslin, W.; Kirk, H.; Streeter, C;; et al. (19,87) Telone H Soil Fumigant:
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121
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iiiniiin!!!:; laiiir ?, ? jps1 sir > -iiR* f"'a1;!!1"' li
IIIH I'mt'J L II ,*,V'WUK
aet''/'!':' illi M,* xi ;j'i^ 11,!'(.; *<*
" if't;?!:,; IC; "''ปf 'ป^ 'ฅ,1111^^ III,;;1'1! illii11," :i: 'i! lpjซ ;v , t,,.,{,
"i" i'H !<>[ illliil'SWItlll1!1:11 311 "i! S S Si-ll';;' * SlllliSf IT I* 'I "K ซ:K '' Kf''*>13 IPS' i. "vi "i:,""; '1 1 Ililill ' i
BIBLIOGRAPHY
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Laboratory Project Study ED: K-6409-(l3). Unpublished study prepared by The
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11 ' :"";'.'' : " ' i, ' ' '",
Moye, H.; Peterson, J.; Malagodi, M.; et al. (1989) Aerobic Soil Degradation of
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Stott, W.;'Steb"bins,K.;"Haut1'K".'; et al ^^TelonelLSoil Fumigant:
pne-year Dietary Toxicity Study in Beagje Dogs: Lab Project Number:
-- ,,_
Barnekow, D.; Becker., G.- Brown, S. et al. (1992) the Nature of the Residue in
Soybeans Following a Pre-Plant Application of Uniformly [carbon-14] Labeled
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JVEET91066. unpublished Jstud"y prepared" Sy DowElanco. 159 p.
ii i
I ;i
I
\mm, in
:il<' "'I'1' U! 'K ''
n; . -,>':, 11 *i',l
-------
MRID
BIBLIOGRAPHY
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42845601
42894201
42946401
42954801
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Houtman, B. (1993) Measurement of Off-Site Air Concentrations of
1,3-Dichloropropene Following Application of Telone Soil Fumigant-Phase 3:
Interim Report: Lab Project Number: ECL92096. Unpublished study prepared
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Barnekow, D.; Becker, G; Brown, S.; et al. (1993) Supplemental Data to: The
Nature of the Resi'due in Tomatoes Following a Pre-Plant Application of
Uniformly 14C-Labeled Cis-and Trans-1,3-Dichloropropene: (MRID No.
42709401): Lab Project Number: MET91065.01. Unpublished study prepared
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Hamburg, A.; Byrne, S.; Huskin, M.; et al. (1993) The Nature of the Residue in
Laying Hens Fed Uniformly (carbon 14)-Labeled 1,3-Dichloropropene: Lab
Project Number: MET92038: HWI6397-116: MC 1075. Unpublished study
prepared by DowElanco North American Environmental Chemistry Lab and
Hazleton Wisconsin, Inc. 253 p. -
Haut, K.; Stebbins, K.; Shabrang, S.; et al. (1993) TELONE H Soil Fumigant:
13-Week Dietary Toxicity Study in B6C3F1 Mice: Lab Project Number:
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Haut, K.; Johnson, K.; Shabrang, S.; et al. (1993) TELONE II Soil Fumigant:
13-Week Dietary Toxicity and 4-Week Recovery Studies in Fischer 344 Rats:
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prepared by The Dow Chemical Go's. Toxicology Research Lab. 400 p.
;Satonin, D.; Hamberg, A.; Byrne, M.; et al. (1994) The Nature of the Residue in
Lactating Goats Fed Uniformly (carbon 14)-Labeled 1,3-Dichloropropne: Lab
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123
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BIBLIOGRAPHY
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Barolo, Daniel M. 1996. Non-Dietary Cancer Risk Policy, EPA Memorandum
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Carletpn X 1995a. Revised Worker and Residential Exposure and Risk
Assessments based on the Data Submitted in Response to the Worker and
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Carleton J. 1995b, Personal communication to C. Scheltema regarding duration
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Carleton J. 1995c. Revised Worker Exposure and Risk Assessments for workers
engaged in loading 1,3-Dichloropropene (Telone), reflecting protection provided
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Carleton J. 1996a. Updated exposure and risk estimates for workers handling
l,3rdichloropropene (Telone), reflecting new study data on "traveler" cylinders
March 4, 1996.
Carleton J. 1996b. Updated exposure and risk estimates for growers handling
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March 28, 1996.
Carleton J. 1996c. Corrected exposure and risk estimates for [onion] growers
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Carleton J. 1997a. Occupational and Residential Exposure Assessment and
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11, 1997.
Carleton J. 1997b. Sections IV and V Addendum to Telone RED Chapter June
3, 1997. . ... .'
Dearfield K. 1989. Second Peer Review of Telone n [Cancer Peer Review
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i ,ii|i| ITIlllt1 '"!' .ill' ' IKIIHIUih.!:.
if, !::;ป;:; I1 '" ../IlillHI' j'i'*":V
i; i 'ii'ini1
I1'1., "in
Li;*1 HI ik i (ฃ.,;,;'..
J.I'l'iitJIiilll' ill! Ilk"'"""''"" iliiiii'i11 .!!''' ;'"'"i:l"i
I ' ;; ' iiiElj- i!,i :',ป,
Giambelluca, Thomas, No date. Hawaii Ground Water Contamination Database,
H Department of Health, University of Hawaii at Manoa.
Glotfelty and Schomber. 1989. Reactions and Movement of Organic Chemicals
in the Soil, Chapter 8, Sawhney and Brown, eds, SSSA Special Publication
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Larsen, Art. 1997. Washington State Department of Ecology, personal
communication.
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Levy A, 1987, Telone H Soil Fumigant: 2- Year Inhalation Chronic
Toxicily/Oncogenicity Study in Rats. EPA Accession No. 403122-01. December
..... 18, 1987. ' '" "' ..... . ":"'
1 (i nil ,i III,
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Levy A. 1988. Telone n Soil Fumigant: 2-Year Inhalation Chronic
Toxicity/Oncogenicity Study in Mice. EPA Accession No. 403123-00. February
5,1988.
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Levy A. 1993. Telone E (1,3-Dichloropropene) - Biomonitoring Human Data
[from] Dow AgroSciences1. August 19,1993.
,- " t
Levy A. 1997. Telone E (1,3-Dichloropropene) - Toxicology RED Chapter
February 20, 1997.
McLaughlin, Marvin. 1987. Oregon Department of Chemical Property
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McMahon T. 1993. Telone E: Review of Pharmacokinetic and Field Trial Data
submitted by the Registrant October 22, 1993. .
Massachusetts InterAgency Task Force. 1986. 1985 Summary report:
Interagency Pesticide Monitoring Program, #14653-15-200- 12-86-CR.
Markovitz A and Crosby W. 1984. Chemical Cafcinogenesis: A soil Fumigant,
1,3-Dichloropropene, as possible cause of hematologic malignancies. Archives of
Internal Medicine. 144- 1409-1411
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Response to the Worker and Biomonitoring Data-Call-in (March 1993), for
Special Review Chemical 1,3 Dichloropropene (Telone). May 12, 1994.'
Mehta A. 1994b. Worker Exposure Assessment Based on the Data Submitted in
Response to the Worker Air and Biomonitoring Data-Call-in (March 1993), for
Special Review Chemical 1,3 Dichloropropene (Telone). June 17, 1994. '
Mehta A. 1994c. Residential/Bystander Risk Assessment of 1,3-Dichloropropene
During Soil Applications. July 19, 1994. ,
Mehta A. 1994d. Worker Risk Assessment of 1,3-Dichloropropene During Soil
Applications; October 6, 1994.
Mehta A. 1994e. Addendum to the Worker Risk Assessment of
1,3-Dichloropropene During Soil Applications. October 13, 1994.
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for extrapolation of air concentrations from Tel one monitoring studies to other
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Ill ill III II 111 11 III I I'I I i i i i Illllil I i I IIP lli ill 1 [ ' V;.*'"".; !.,' ''' v, ' L ;"i- ,;: -;
11|| | I|fl|| I I i 'I I, I (i111 ' P 11 lli l i i i I III ' 11 i 'fi| I >'. iil'O.ji '*,' ' '','' i, '"""!''', ''1-
Michell R. 1995. Response to 1,3-D Use and Exposure Related Questions. April
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^f|f :ป'ง' "? '' "!!|*!::: >y ' * ^ "^'^ for Tolerances. August 24, 1995.
j^bSfl;,?!!1 ":'''" ' l;ง ,'ฃ':; i^::;. &;':';! 'LQuest JfA. 1985. [Carcinogenicity] Peer Review of Tel one n. November 10,
l-'H!' '! ..... ;'" Xf.r,}. ...... V ...... S'SI"'"!;,.;":1:'; . Mil ' VJi ?!
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' '" ................................ ............................................. ' ' ..............
::: : ':'": ": : ' -".:". : ' " ' ' ;;: i; "I: ; ' " . : September 1990.
iปilli|llll ...... i,iซซ!l'i,i ! ............... ilh Jlllli 111, , <|i Illullliilii ," ........ >< . il" < i ''lll.i 'i >'.' Ill ..... III! ' -** .................................................
ii ' ;' i":1!!,,,! a ,i
^PPJ- ^P^^P6?3^^?^0^^^?11^11116^11^ Consumer
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id11! niiji'i v: !iniii v ,., it', !r
Pjlvi'.ซli|l(li IP'JS '. , ปi 1,1 -I .
'1*-;,!"!:'/.:1;:-* :"';""::"' ,;':'; :',.'"' 1^^-^ !??ง 1^el^^se^ ^s^ Assessmen|; and R Status of
'^~~ ::'',;::::;:;":: ;":,,' ;;;;;;"' : ;,:::!,' " , 1,3-lMcMprpprOpene. February 7, 1996.
Tuazon, E.G., Atkinson, R., Winer, A.M., and I N. Pitts Jr. 1984. A study of
the Atmpshperic Reactions of 1,3-Dichloropropene and .Other Selected
Organochlorine Compounds, Arch Environ. Contam. Toxicol. 13, 691-700.
iiiHiiii'j iiiiniiii "siniii' ,,,i i nil fi.' .''.!(.. ;.;;:, 't.i'i ....... afc^iTin ...... !.. ........ :t ......... : ........ : ....... ;,- ................ ป:,' .......... M 1 ........... ..... I ..... ' ' '" ''"'' ' '
1;;:;:";:!; :.; ..... ,; ;;:::! , *:"::i:'". ;;:'" . ^;^$]B|>A,"JK|!^J "Integrated Risk Information System Online Database. Reference
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K ..... ......... w
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"'.-'".-' "'.:'.'.": : '. -: ^997; ' "" '' '' " .'
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I'M ....... I'll1"! , Biiiik" ! '' ' JiiJiii 'I: : :: ::j' Wiiii; ; ........ ซ ..... ! . tiai1 1. ซ ' , ; ......... '& ...... , ;ซ ...... IB-" , > "S ..... c : Jt;*1!^ ! "?, ,ปป" ..... IIEMSI j< ...... v. ; < ! 1 1 >, ...; ; ,,(; , ,:; .p, i: 'fwsyt; ..... ...... IKS,;" , ;t ; , ;:,;, . ;, . ,. ; ; : f. !, : .
128
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USEPA 1997c. Ad Hoc Occupational and Residential Exposure SAC.
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L IE III1 Hi'! 1 JIHL! ' ii i'JI , :
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERITFED MAIL
2 2 1998
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
produces) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section El below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 5; or
2:
3.
Why you believe you are exempt from the requirements listed in this Notice and in
Attachments, Requirements Status and Registrant's Response Form, (see section
m-B);or
Why you believe EPA should not require your submission of product specific data
in the manner specified by this Notice (see section ffl-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply ,
with its requirements or should be exempt or excused from doing so, then the registration of your
131
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n-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Insert B, Requirements Status and Registrant's Response Form (Insert Bl within the time frames
provided. ....''
H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guideline^ are available from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are "also acceptable if the OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (40 CFR ง 158.70). When using the OECD protocols,
they should be modified as appropriate so that the data generated by the study will satisfy the
requirements of 40 CFR ง 158. Normally, the Agency will not extend deadlines for complying witii
data requirements when the studies were not conducted in accordance with acceptable standards.
The OECD protocols are available from OECD, 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcM2)flfl NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein; this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-InfsY or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
m-A. SCHEDULE FOR RESPONDING TO THE AGFNrv
The appropriate responses initially required by this Notice for product specific data must be
submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent to
Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to failure to
comply with this Notice are presented in SectionTV-A and IV-B.
133
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and Registrant's Response Form (Insert B). If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the option'chosen to address the data
requirement. . ;
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form (Insert A) that you agree to satisfy
the product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form (Insert A) related
to data production for each data requirement Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six options
discussed under item 9 in the instructions for completing the Requirements Status and Registrant's
Response Formflnsert A). These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share) , '
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) Jam submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing.an Existing Study)
Option 1, Developing Data - If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced here in and in
the attachments. All data generated and submitted must comply with the Good Laboratory Practice
(GLP) rule (40 CFRPart 160), be conducted according to the Pesticide Assessment
Guidelines(PAG), and be in conformance with the requirements of PR Notice 86-5.
=-'/ ' - ' - .
The time frames in the Requirements Status and Registrant's Response Form (Insert A) are
the time frames that the Agency is allowing for the submission of completed study reports. The
noted deadlines run from the,date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice arid
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing. While EPA is considering your request, the original deadline remains. The Agency will
respond to your request in writing. If EPA does not grant your request, the original deadline
135
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remains. Normally, extensions can be requested only in cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses. Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
, ' "," ' I,' ,, ' ';"
I II I I I || | ' F . ',, | ' , , "I ;,;ป
Option 2, Agreement to Share in Cost to Develop Data Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data= tables that your product and at least one other product are similar for purposes of
depending on the same data. If mis is the case, data may be generated for just one of the products in
the group. The registration number of the product for which data will be submitted must be noted in
the agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPAwithdocumentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development This option only applies to
acute toxicify and certain efficacy data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend ypur.regjistration(s), although you do not comply
iMtl]the, daja, submission, requirements of this Notice. EPA has determined that as a general policy,
,,,.,; ||s;ejitj5ffe of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrants) developing the data has refused to accept your offer. To
qualify for this option, you must submit documentation to the Agency proving that you have made an
offer to another registrant (who has an obligation to submit data) to share in the burden of
,, ', developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Son of Offer^toCqst^Share in ffie^Deyelppment of Data, Attachment 7. In addition, you
npn^sjtratg Jhaifc jjhg ^pjigrjegistrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
^eement to be bpimd^b^^ section3(c)(2)(B)(iii) and must
not qualify this offer. The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-in Response Form
(Insert A) and a Requirements Status and Registrant's Response Form (Insert B) committing to
jBs^t'i.rSsyelop and submit the data required by this Notice.
!i '"i , : 88! I ; i 111 I III I i i i |i I Hi I .. '. \r , : '', I , If
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\miiiiiiiiiiii, :& ij^^^ ;^^^^^^ iiiai:;: iiiiiiiiiiiiiiii! IJM^^ ' ii!^^^ iiai 11^^ ; iiii .ii, .i-iiajii & A amAi >:4:.;: "i,;. i -.. i,: j,: ,.;ii";.,,.:.: <, ',;. ':. j;.. J
-------
In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burdens of developing the.data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails to
develop the data or for some other reason is subject to suspension, your registration as well as that
of the other registrant will normally be subject to initiation of suspension proceedings, unless you
commit to submit, and do submit the required data in the specified time frame. In such cases, the
Agency generally will not grant a time extension for submitting the data.
Option 4, Submitting an Existing Study - If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by this
Notice. You may only submit a study that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which predate issuance of this Notice. Do
not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to be
repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly rtet:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements of
the Good Laboratory Practice (GLP) regulation,,40 CFR Part 160.' As stated in 40
CFR 160.3(j)." 'raw data' means any laboratory worksheets, records, memoranda,
notes, or exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and evaluation of the
report of that study. In the event that exact transcripts of raw data have been
prepared (e.g., tapes which have been transcribed verbatim, dated, and verified
accurate by signature), the exact copy or exact transcript may be substituted for the
original source as raw data. 'Raw data1 may include photographs, microfilm or
microfiche copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments." The term
_ "specimens", according to 40 CFR 160.3(k), means "any material derived from a test
system for examination or analysis."
b.
Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
137
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The criteria for submitting an existing study, as specified in Option 4 above, apply to all data
submissions intended to upgrade studies. Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with each of those criteria as well as
a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies generally
will have been classified as "core-guideline" or "core minimum." For all other disciplines the
classification would be "acceptable." With respect to any studies for which you wish to select this
option you must provide the MRTD number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.'
If you are citing a study of which you are not the original data submitter, you must submit a
completed copy of EPA Form 8570-34, Certification with Respect to Citations of Data (in PR
Notice 98-5). ,\ ,
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form (Insert A) and the
Requirements Status and Registrant's Response Form (Insert BY, as appropriate
ni-D. REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is inappropriate, you
must attach a complete justification for the request, including technical reasons, data and references
to relevant EPA regulations, guidelines or policies. (Note: any supplemental data must be submitted
in the format required by PR Notice 86-5). This will be the only opportunity to state the reasons or
provide information, in support of your request. If the Agency approves your waiver request, you
will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If the Agency
denies your waiver request, you must choose an option for meeting the data^requirements of this
Notice within 30 days of the receipt of the Agency's decision. You must, indicate and submit the
option chosen on the Requirements Status and Registrant's Response Form. Product specific data
requirements for product chemistry, acute toxicity and efficacy (where appropriate) are required for
all products and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the due date for
the study in question. Waiver requests submitted without adequate supporting rationale will be
denied and the original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
139
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^FlF&A section 3fc)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
'rri;3 ซ:;**! ', [, [Suspend include, but are not limited to, the following:
: 'l! ' " ' * ;)":!!;!;''::;,: '!i: ;""l;:lv [". I , .S%PP,tp respond as required by this Notice within 90 days of your receipt of this
=jjji."> ' :::;';i'ir'''!;;;;:,: i "Notice.
ii'H1'**},;11,1'!!!!:;: ii1 i , > Iniu ,,,i ป, :'?'}.. ' r'i"\, !" i;i" hlil '" Mi1,,,,',! , it'1'.1 iy, iM^i1^ n ii i i i i n n i | < . \- ' " , " < r
;,:;:;!;&, l^Wfi^lH^Pllf^^6 required schedule an acceptable proposed or final protocol
.when such is required to be submitted to the Agency for review.
11111,11 TLIJIi !ซ'",I? 'IP " ' Ii'1 ', " | 'ป ,!l '. 'I !'' '"' ' :,
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3. failure to submit on the required schedule an adequate progress report on a study as
''! mil i i ii in *-ti,i*iT-*
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5, Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
informatic|n, pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6- Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section m-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant towhom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a. ^P EPA of intent_todevelop and submit the data required by this Notice
on a Data Call:In Response Formflhsert A) and a Requirements Status and
;;" . WE i, .1; i''. i : I ;ป;''- 1m .' s ' Registrant's Response Formflhsert B\.
, , , ' \ '
,:'"!'" i op^'^lr ..A1" ,"!', ;M "'ijiijrป;; J^jiilill^ i in mi in i i in i i i i i ;,, |'' L i
b". fulfill the: commitment to deyelpp and submit the data as required by this
>;> -.|.i ,;;,,.,..,;;. ; ; ---^ ;_ .NotiCej OF _ '. _
fM;iftw,f,;rซ:IT ,*!.:"' i: iiiiisii' .I'Vi-'liflffi-1 il'i ,)ซซ jv-,iv']v1 "''"s1 :" ':y" ;ili|1" '''- 'i'"*.;'ป*'''"'"'i1''"''' i"1''11'1"'^"1"'' "' m-,; M- '"'' ;l * ' ' , < '';: ซ
;;;;;;;;;;;;;ป;;;,; ซ..; i" ,ป. 'i;,,;, u/-.^^^,.., ,. ,,Qthej[wase,:,|^ei,iappropnate steps to meet the requirements stated in this
'I!!!! ' *:?_'": ::;,;;;.,;' ';. ":Sf I?*! '?; Notice, unless you commit to submit and do submit the required data in the
:::.::,;'.:.:::: ;:,;;,,:::;;, :." "specified time frame.
9. Failure to lake any required or appropriate steps, not mentioned above, at any time
;:;:;:=', ., =:;:; ,,.,;,:_:,_ u;/QUfJJging the issuance of this Notice. ' '
'iiilllllti' i" : J!iJiปiJi.;;t'if t'1 ,>: I1' 'Ji. ;,. ;;iiiiiii; Hi," I III II I I I II I > II I , " ' i
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111 iiQi:!1, 1'ijri1 >h '-I, ' i,/i: ' j'i" ' iviiin ' ill i 11 I i I I ii ill I >'
'I iiiiiiL ! j,' "I '"' * T'', il! ^'i1''!1 "s/illi'i" ''i oiisLii M1',! Mlli1 lil', i'"''!':" jl1"' I1'1 Illllr, IliliKIIIII1 'l"i'''i!'' ii^il^iiilV''^.'!^^!!!!!*''!'!'!.''!!!1'!!'! in;: 140
! fl!!!!i; f-llt"!;' M!' ii " ", 11"!" ' i '" ' f i'' >.:' V !"l!lll!'' f ,;''
V,:i ฃ'+':.'"ปซ ""I'.
-------
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, ;but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-in Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox.Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies. Such requirements include, but are not limited to, those
relating to test material, test procedures, selection of species, number of animals, sex and
distribution of animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary report
will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or canceled if doing so would be consistent with the
purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
. suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly > the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended prpduct(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your produces) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of clearly
demonstrating to EPA that granting such permission would be consistent with the Act. You must
also explain why an "existing stocks" provision is necessary, including a statement of the quantity of
existing stocks and your estimate of the time required for their sale, distribution, and use. Unless you
meet this burden the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your produces) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
141
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'fill1 IE
id rid i nil
I, ill I 1,1,1 uliLl,
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or Use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until the
Stocks are exhausted. Any sale, distribution or use of stocks of voluntarily canceled products
containing an active ingredient for which the Agency has particular risk concerns will be determined
oh case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by this
Notice will not result in the Agency granting any additional time to sell, distribute, or use existing
stocks beyond a year from the date the 90 day response was due unless you demonstrate to the
Agency that you are in full compliance with all Agency requirements, including the requirements of
this Notice. For example, if you decide to voluntarily cancel your registration six months before a 3
year study is scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith manner must have
been submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V.
REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
is registered a registrant has additional facial information regarding unreasonable adverse effects on
the environment by the pesticide, the registrant shall submit the information to the Agency.
Registrants must notify the Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of studies, regarding unreasonable adverse
effects on man or the environment. This requirement continues as long as the products are registered
by the Agency.
SECTION VI.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact persons) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Insert A) and a completed
Requirements Status and Registrant's Response Form (Insert B) for product specific data) and any
other documents required by this Notice, and should be submitted to the contact person(s) identified
JSnA^fa11!0.!Is K#le, XSllffifery cancellation or generic data exemption option is chosen, only the
Data Call-in Response Form (Insert A) need be submitted.
142
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic s
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
eois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
1 -
2 - .
3 -
' 4 -
5 -
Data Call-In Chemical Status Sheet
Product-Specific Data Call-in Response Form (Insert A)
Requirements 'Status and Registrant's Response Form (Insert B)
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
143
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM
(msElr;'A) FOR PRODUCT araicDPicpATA ''[ :
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this option,
you will not have to provide the data required by the Data Call-in Notice and you will
not have to complete any other forms. Further sale and distribution of your product after
the effective da|e of cancellation must be in accordance with the Existing Stocks
provision of the Data Call-In Notice (Section iy-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
productis identical to another product and you.qualify for a data exemption, you must
"':.z".;. :i'.'. " I,;: V: :.': ::r^^T,,ri'siporid""with "yes" to Item 7al&fOT) or TB (EUP) on this form, provide the EPA
registration numbers of your source(s); you would not complete the "Requirements
Status and Registrant's Response" form. Examples of such products include repackaged
products and Special Local Needs (Section 24c) products which are identical to
federally registered products.
Item fa. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
III Illlllll I i 111 III I III I III IIII11 I f III I III I I I I 1.1 ./..I IjN!^ 'hi! .''I !,,,' ป " fr M.'','! : ' ' i ,:* J',", ' ,, ' '"< ;ซ;>" |l;' ! ''',* /'..I
ii i in i i i inn i in i ii i n i i in i i iiiiiiii i i i hiit! I iivliiiiii,"!"' di'fe ^ivnlli!,:'1'!' I'!1:1"' ' I1'.1';'1 fซf ""I'1'1'1' ' .i.1'"'! '": '"',ซ '.. i" ". < ';'::' ' "!< j!,,* i
itemTb. For each end use product (EUP|fpr which you wish to maintain registe
agree to satisfy the data.requirements by responding "yes." If you are requesting a data
waiver, answer "yes" here; in.addition,onthe"Requirements Status arid Registrant's
Response" form under Item 9, you must respond with Option 7 (Waiver Request) for
each study for which you are requesting a waiver. See Item 6 with regard to identical
products and data exemptions.
Items 8-11. Self-explanatory.
n mi ii in i in i iiini i n i in i i i in iiiiiiii i i nr .I'Miiii,,,"1',1 ''"iii"! 4 hin HI mi.'S'l'i'ii, k',",i,, i.1 .14,1!,'..'I;,,;1, iir1,,1!1 :,ii"i.,: n, ป!'''ii,r,,: .i,;,,' "i,.i'i "we: ''n'ijyii"!;!!1'1 i; ,,|I|:F ,. iiiini!1',1 , ,r , ,|. '",',i;" ' / '' i1"". .;"',"i : , " ,, ; Hvi'm,;, i'"iii
NOTE: You may provide additional information that does not fit on this form in a signed letter
that ftcconapanies this form. For example, you may wish to report that your product has
aJlpady been transferred to another company or that you have already voluntarily
canceled mis product For these cases, please supply all relevant details so that EPA can
ensure that its records are correct.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM (INSERT B) FOR PRODUCT SPECIFIC DATA
Item 1-3
Item 4.
Item 5.
Item 6.
Item 7.
ItemS..
Item 9.
1.
2.
Completed by EPA. Note the unique identifier number assigned by EPA in Item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
The guideline reference numbers of studies required to support the product's continued
registration are identified. These guidelines, in addition to the requirements specified in
the Notice, govern the conduct of the required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart C.
The study title associated .with the guideline reference number is identified.
The use pattern(s) of the pesticide associated with the product specific requirements is
(are) identified. For most product specific data requirements, all use patterns are covered
by the data requirements. In the case of efficacy data, the required studies only pertain
to products which have the use sites and/or pests indicated.
The substance to be tested is identified by EPA. For product specific data, the product
as formulated for sale and distribution is the test substance, except in rare cases.
The due date for submission of each study is identified. It is normally based on 8 months
after issuance of the Reregistration Eligibility Document unless EPA determines that
a longer time period is necessary.
Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-in Notice.
I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-in Notice. By the specified due date, I will also submit: (1) a completed
"Certification with Respect to Citations of Data (in PR Notice 98-5)" form (EPA
Form. 8570-34) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not submitted
on time, my product may be subject to suspension. By the specified due date, I will also
.151
-------
7.
By the specified due date, I will cite an existing study that the Agency has classified as
acceptable or an existing study that has been submitted but not reviewed by .the Agency
(Citing an Existing Study). If I am citing another registrant's study, I understand that
this option is available only for acute toxicity or certain efficacy data and only if the cited
study was conducted on my product, an identical product or a product which EPA .has
"grouped" with one or more other products for purposes of depending on the same data.
I may also choose this option if I am citing my own data. In either case, I will provide
the MRBD or Accession number(s) for the cited data on a "Product Specific Data
Report" form or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"'
form (EPA Form 8570-34) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. [Note:
any supplemental data must be submitted in the format required by P.R. Notice 86-5].
I understand that this is my only opportunity to state the reasons or provide information
in support of my request. If the Agency approves my waiver request, I will not be
required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency
denies my waiver request, I must choose a method of meeting the data requirements of
this Notice by the due date stated by this Notice. In this case, I must, within 30 days of
my receipt of the Agency's written decision, submit a revised "Requirements Status and
Registrant's Response" Form indicating the option chosen. I also understand that the
deadline for submission of data as specified by the original data call-in notice will not
change. By the specified due date; I will also submit: (1) a completed "Certification
With Respect To Data Compensation Requirements" form (EPA Form 8570-34)
and (2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE:
You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily
canceled this product. For these cases, please supply all relevant details so-that EPA can
ensure that its records are correct. V
153
-------
1 1 I
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EPA'S BATCHING OF TELONE (1,3-DICHLOROPROPENE) PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
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In an effort to reduce the time, resources and number of animals needed to fulfill the acute
loxicity data requirements for reregistration of products containing Telone (1,3 -dichloropropene) as the
active, ingredient, the Agency has batched products which can be considered similar for purposes of acute
toxicity. Factors considered in the sorting process i include ^each product's active and inert ingredients
/identity, percent composition and "^Qio^c^ ^^r^ _g ^ formulation (e.g., emulsifiable
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concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification,
precautionary labeling, etc.). Note that the Agency is not describing batched products as "substantially
similar" since some products within a batch may not be considered chemically similar or have identical
use patterns.
'I'1"1'111;;;' Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require,
time, acute toxicity data, for an individual product should the need arise.
M' M '. 11 - ' ;&K v' : av.; ' li ;ป'ป ;i ; ' ' '
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Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is the
registrants1 option to participate in the process with all other registrants, only some of the other
fPlpistrants, or only their own products within a batch, or to generate all the required acute toxicological
stiidje^lpr ^ich, gf their own products. If a registrant chooses to generate the data for a batch, he/she
must use one of the products within the batch as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided that the data base is complete and
^alid by today's standards (see acceptance criteria attached), the formulation tested is considered by EPA
to be similar for acute toxicity, and the formulation has not been significantly altered since submission
and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data
is referenced, registrants must clearly identify the test material by EPA Registration Number. If more
than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given m the Data' Cdl^l
-------
>to participate in a batch does not preclude other registrants in the batch from citing Ms/her studies and
offering to cost share (Option 3) those studies.
Ten products were found which contain Telone as the active ingredient. These products have
been placed intof our batches in accordance with the active and inert ingredients and type of formulation.
Batch
1
EPA Reg. No.
62719-32
11220-01
% Active Ingredient
94.0
94.0
Formulation Type
LIQUID
LIQUID
Batch
2
EPA Reg. No.
8536-21
11220-20
62719-12
. % Active Ingredient
1,3-dichloropropene ... 79.9
chloropicrin ... 15.0
1,3-dichloropropene ... 79.9
chloropicrin . 15.0
1,3-dichloropropene . 78.3
chloropicrin ... 16.5
Formulation Type
LIQUID
LIQUID
LIQUID
Batch
3
EPA Reg. No.
8536-22
11220-21
11220-22
% Active Ingredient
1,3-dichloropropene ... 65.8
chloropicrin ... 29.7
1,3-dichloropropene ... 65.8
chloropicrin ... 29.7
1,3-dichloropropene ... 61.1
chloropicrin ...'34.65
Formulation Type
LIQUID
LIQUID
LIQUID
155
-------
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4
EPA Reg. No.
8536-08
11220-15
% Active Ingredient
1,3-dichloropropene ... 37.6
chloropicnn ... 59.4
1,3-dichloropropene ... 35.3
chloropicrin 58 8
Formulation Type
LIQUID
LIQUID ~
HI13K* lilt!- if 33jS,,M!SwSng summarizes acute data requirement by batch:
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LIST OF AVAILABLE RELATED DOCUMENTS AND ELECTRONICALLY
AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/. '
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on your
computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy, i
3. Mail the forms, along with any additional documents necessary to comply with EPA regulations
covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information'
or'Sensitive Information.' ,
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
orbye-mailatwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
FttwasjRe
8570-1
8570-4 '
8570-32
8570-34
8570-35
8570-36
8570-37
jairedifbrJlespoBdhigtotheKED: - ' -"", ; ,, ^ / ^ , . < -";"'
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Certification of Attempt to Enter into an
Agreement with other Restraints for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5)
Data Matrix (in PR Notice 98-5) '
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://wvAv.eDa.gov/oDDrd001/forms/8570-l.pdf
http://www.eDa.aov7or>prdOOI/forms/8570-4.pdf
http:/Avww.epa.eov/oDprd001/forms/8570-32pdf
http://wvAv.epa.gov/ODTOmsdl/PR Notices/pr98-5^df -
http://www.epa.gov/opppmsdl/PR Noticesxpr98-5.pdf.
http://www.epa.2ov/oDTOmsdl/PR Notices/pr98-Lpdf
http://www.eDa.gov/oDppmsdl/PR Notices/or98-l pdf
' . - -- - -
159
-------
B'i: c'taini; i!11" ins ;i' '"in1 .Jiiiiii! i 'i 'i< .i1 < "i
ป,;! HI ,::' ,!, iln liin! !!,:,i,
ซ!;rntwr jnป ;ra' '.iiuw" -M:.''.::;; ran1. ซ i .i:Bill!1! ;!'i,s,i> ';', ., - i .'.%,i .')iv; :!:'! ( 'fcidv.?:ป;>',,: ! .-. '.',. -:
fijIfel'TIUIII'llljillB1"1;, I'll! i ill Jill IIIIIIIP,': III 'I'l'i,,/ l'ป jlilll'l', M,1*" , f lililllIM1 ',,"1111 , /' '! ;" I 'I 'II ,;* .'m ป. T M nilirl'l nflr '"'ill,1' ',:,,!, , 'I1 i'jlli
WI'UiilWi'MI,, 'I'i'i'i1 ,' V '"llll'ii'fti ii ' i|:.i;ป i
'" 'il '!''!' "iป '
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i " ., .' 'I', """iiiliilii 'lllliiMV: ,.1 I
11,;,!!; I', ill'. I11 ';
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with. Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
htto:/Avww.eDa.aov/opp3-d001/forms/8570-5.pdf.
hto://www.epa.gov/opprd001/forms/8570-17.pdf.
littp:/Avww.eDa.sov/opprd001/foms/S570-25.pdf.
http:/Avww.epa.aov/opprd001/forms/8570-27.pdf.
http:/Avww.epaฑgov/opprd001/forms/8570-28.p_df.
http:/Avww.epa.gov/opprd001/forms/8570-30.pdf.
iriiiiiiiiiMi1^
I, t: 'ITU 111:1 ,,i ', is1, , ,ii". '.
160
-------
Pesticide Registration Kit
Dear Registrant:
www.epa. gov/pestici des/registrati onki t/.
a.
b.
c.
d.
e.
f.
g-
h.
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide., and Rpdentieide Act (FIFRA) and the Federal Food
Drug,and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA) of 1996. '
2. Pesticide Registration (PR) Notices
83-3 Label Improvement ProgramStorage and Disposal Statements
84-1 Clarification of Label Improvement Program
86-5 Standard Format for Data Submitted under FIFRA
87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
87-6 Inert Ingredients in Pesticide Products Policy Statement
90-1 Inert Ingredients in Pesticide .Products; Revised Policy Statement
95-2 Notifications, Non-notifications, and Minor Formulation Amendments
98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format arid requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR Notices.
Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader.)
EPA Form No. 857.0-1, Application for Pesticide Registration/Amendment
EPA Form No. 8570-4, Confidential Statement of Formula *' " '
EPA Form No. 8570-27, Formulator's Exemption Statement
EPA Form Nq. 8570-34, Certification with Respect to Citations of Data
EPA Form No. 8570-35, Data Matrix
General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader.) '
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
40 CFR Part 158, Data Requirements for Registration (PDF format)
50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
a.
b.
c.
d.
e.
c.
d.
e.
f.
g-
Before submitting your application for registration, you may wish to consult some additional
sources of information.
These include:
1. The Office of Pesticide Programs'Web Site
161
-------
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ma i;;."
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ijiiK > !/'
; ...... iii'iii ..... Kim' .......... SA
H c wrx s ^ซit.JiilliNii,'' 'v "IV1
>.!':งj: --i^^e^DooHdt^'V^mard ....... I^nnationition Applying for Registration of Pesticides in the
I:1;:;!;:1' ' ^*^1^t^.St^eslC" ^92-^18 nfavaiabie ..... ^rough 'thVNatibnal' Technical Information
*:;;;'ป ................................ _ .................... '
ii'^l^i^jgf Technical Information Service (NTIS|
:*: "'" ................. ' [[[ ......... ' ........ ' .....
Springeld, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from the
passage of the FQPA andthereorganization of the office of Pesticide Programs. We anticipate that this
publication will become available during the Fall of 1998.
3. TheKaona Pestidde omationenstem qsjpjRs'-j of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for
|u,bjcrijptijDnฃ and custom.searches. You can cpntact NPIRS by telephone at (765) 494-6614 or
ซ*''. iiiiil.;C can provide information on active
fngfedients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone
$" K|^^^^ji^||'^ ^"^
Tne_ Agency will return a notice of receipt of an application for registration or amended registration,
experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his
Submission a stamped, self-addressed postcard. The postcard must contain the following entries to be
,nipnnun "11,111 11111111111.1.11111.11,111111,: an nwiiiป,,. ,IH i iiiiiiifiriiiiiiii,,,A, , , ? ', *T * S* ,,
m !.
i :,; ;:ii|..i.!;, i ,,i nil. 'i - ".i1" , j'l.'!., .!h. ' ".,>..!! 1 11,1'lii1 .M i,.":;.,.1 j ;i id1 " vi
Date of receipt
:| llliTrCR'111*1 " '"i'"'"'* ......... "' ' "f'R,1 ' * ........ ' ..... ' .................. 'i ........ " .....................
EPA identifying number
the Product Manager assignment
|| JSe specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying
:.;,.':Hle Syjmbol or petition number for the new submission. The identifying number should be used
"i!i'fi."ii.||lJงSej;e,iryou contact the Agency concerning an application for registration, experimental use permit,
on.
To assist us in ensuring that all data you have submitted for the chemical are property coded and
assigned to your company, please include a list of all synonyms, common and trade names, company
fji'.iffperimental codes, and other names which identify the chemical (including "blind" codes used when
::BKJ5lKi;'Jlti.l:lฅ":f-^^Sl)le was submitted fortestingby commercial or academic facilities). Please provide a CAS number
iir; iin" |iซ: 'i< i,, iiiiir;,i ..wi'i"' !"i,i'". riiitiiufcii
Illlil'I' !,!<"'! "1i;" " I,,, UN'"' iii' /,;'< oil1 Till!I'
SifflWjHrK
!l " ' ll"1"1" "" '1|"'1"
lKHri:**!i7*l1^T1:!t'.'. .::. hii!'.'.':
; EiFiilP1!".'!" WB'lllli'n1 'till illli, ' ,. iilH'"i Pi 1!
Illllll ..... IIHi
-------
Documents Associated with this RED
The following is a list of available documents for 1,3-Dichloropropene that may further assist
you in responding to this Reregistration Eligibility Decision document. These documents may be
obtained by the fpllowing methods: ll
Electronic
File format: Portable Document Format (.PDF) Requires Adobeฎ Acrobat or compatible, reader.
Electronic copies are available on our website at www.epa.gov/REDs, or contact
< Lisa Nisenson at (703) 3 08-8031.
1. PR Notice 86-5. .
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for 1,3-Dichloropropene.
The following documents are part of the Administrative Record for 1,3-Dichloropropene and
may be included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents
are not available electronically, but may be obtained by contacting the person listed on the Chemical
Status Sheet. '
1.
2.
3.
Health and Environmental Effects Science Chapters.
Detailed Label Usage Information System (LUIS) Report.
Appendix A - Table of Use Patterns Subject to Reregistration
The following Agency reference documents are not available electronically, but may be obtained
by contacting the person listed on the Chemical Status .Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria.
163
-------
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