United States Prevention, Pesticides EPA738-R-98-018
Environmental Protection And Toxic Substances . November 1998
Agency (7508C)
Reregistration
Eligibility Decision (RED)
Dicofol
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United States
Environmental Protection
Agency . _,_
Prevention, Pesticides
And Toxic Substances
(7508C) '
EPA-738-F.-98-016
November 1998
R.E.D. FACTS
DICOFOL
Pesticide
Reregistration
Use Profile
Regulatory
History
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 reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
and environmental effects of each pesticide. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters 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
0021, dicofol.
Dicofol is an organochlorine miticide/pesticide used for foliar
applications, mostly on cotton,' apples, and citrus crops. Other crops include:
strawberries, mint, beans, peppers, tomatoes, pecans, walnuts, stonefruit,
cucurbits, and non-residential lawns/ornamentals. Formulations registered for
use on food/feed crops include emulsifiable concentrates, and wettable powder
formulations. These formulations may be applied as concentrated or dilute
sprays using aircraft, duster, groundboom, and sprayer.
Dicofol was first registered as a pesticide in the U.S. in' 1957. EPA
issued a Registration Standard for dicofol on December 30, 1983. Data Call-
ins on September 30, 1991, March 3, 1995, and October 13/1995 required
additional residue and ecological effects data.
Currently, 32 dicofol products are registered, including end use and
manufacturing use products.
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Human Health
Assessment
Toxicity
Exposure to pesticidal residues of dicofol to the U.S. population can
occur via diet through its usage on a wide array of crops, such as apples and
citrus. Occupational exposure to dicofol occurs to pesticide workers via its
agricultural application.
The Agency has calculated the chronic dietary reference dose (RfD) for
dicofol, the amount of pesticide believed not to cause adverse effects if
consumed daily over a 70 year lifetime, at 0.004 mg/kg/day based on hormonal
toxicity seen in both sexes of an oral chronic dog study.
1 '" , , . , '', ' i i , , ' |i' ' ,,
EPA has calculated an acute dietary reference dose for dicofol, the
amount of a pesticide which can be consumed in one day and believed not to
cause adverse effects, of 0.05 mg/kg/day based on neurotoxic effects observed
after a single oral dose in a rat acute neurotoxicity study.
For the purpose of determining short-term and intermediate term worker
risk, the endpoints of concern were selected for developmental and hormonal
toxicity observed in rabbit and rat studies.
For the purposes of precautionary language for the registered product
labels, dicofol has been found to be toxicity category El (the second lowest of
four categories) for acute oral toxicity, acute dermal toxicity, acute eye
irritation, and acute dermal irritation. Dicofol has been found to be toxicity
category IV (lowest category) for acute inhalation.
Dietary Exposure
People may be exposed to residues of dicofol through the diet.
Tolerances or maximum residue limits have been established for dicofol. (See
40 CFR ง180.163). The raw agricultural commodity tolerances listed under 40
CFR ง180.163 are currently expressed in terms of dicofol per se, with no
animal tolerances established. The dicofol RED recommends that the listing of
: tolerances for residues in/on plant commodities be designated 40 CFR
ง180.163(a), and that a new section, 40 CFR ง180.163(b), be provided for the
listing of animal tolerances expressed in terms of the combined residues of
dicofol and its metabolite FW-152.
The dicofol RED recommends that dicofol tolerances be revised as
follows: 1 tolerance level is recommended to be revoked, 4 tolerances are
recommended to remain unchanged, 3 tolerances are recommended to be
raised, 45 new tolerances are recommended to be established, and 33 tolerance
levels are recommended to be moved to a crop grouping. In most cases,
tolerance levels being moved to a crop grouping are also having their tolerance
levels lowered, based on new field trial data.
Chronic dietary food exposure is calculated at 38% of the RfD in the
most at-risk population (children, 1-6 years), not enough to cause concern.
Acute dietary exposure estimates, while higher (9.0% of RfD in the most at-risk
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population, non-nursing infants, less than 1 years old), still do not exceed the
Agency's Level of, Concern.
, When possible exposure to pestic'idal residues of dicbfql through
drinking water, taken from conservative modeling estimates, are included in the
dietary assessment, the Agency still does not have a risk concern for any
population subgroup with either acute or chronic dietary exposure.
Occupational and Residential Exposure
, The risk assessment in this RED raises some strong concerns for dicofol
mixers/loaders/applicators, and field workers. The endpoint of concern is
hormonal and developmental toxicity: At the present time, most short term.
and all intermediate term scenarios result in Margin of Exposures (MOEs)
which exceed the Agency's level of concern, even'with engineering controls.
However, the Agency believes that the default assumptions used to arrive at
.this conclusion may have led to an overestimation of that risk (i.e. the default
assumption of 100% dermal absorption and a initial Dislodgeable Foliar '
Residue (DFR) level at 20% of the application rate and assuming residue
dissipation of 10% per day). To improve our estimation of dicofol risk, the
registrants have initiated a dermal toxicity study, which is due to the Agency
on December 31, 1998. In addition, as a result of a Data Gall In from October
13, 1995, the registrants are also completing a DFR study, due in October,
1998. EPA will consider results of these studies in a revised risk assessment.
In the interim, while this data is being developed and evaluated, the registrants
have agreed to undertake risk mitigation measures (described in the Risk
Mitigation section of this Fact Sheet) to address the occupational risks
identified in this RED. ."..'"
EPA will revise the Restricted Entry Interval (REI) based upon results
of the dermal toxicity study and DFR study:
Because all residential uses are being voluntarily canceled by the
registrants, residential risk is not a concern. - \
FQPA Considerations
EPA conducted additional risk analyses using available data in response
to the new FQPA requirements. Based upon data evaluated by the Agency,
the 10X FQPA safety factor is being reduced to 3X for all population
subgroups for both chronic and acute dietary risk.
The Agency has not made a determination whether dicofol or any other
pesticide has a common mechanism of toxicity for either cancer or non-cancer
effects and require a cumulative risk assessment For the purposes of this
RED, EPA has considered only the risks from dicofol. If required, cumulative
risks will be assessed when methodologies for determining common mechanism
of toxicity and for performing cumulative risk assessments are finalized.
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Environmental
Assessment
Environmental Fate
Dicofol has a short to intermediate half-life (days to months) in
laboratory studies. Major routes of dissipation are hydrolysis in neutral and
alkaline environments and microbial-mediated degradation.' Dicofol is likely to
be more persistent in acidic than neutral or alkaline soils or waters and in drier
conditions. Laboratory and field data suggest that dicofol is not very mobile,
and neither leaching nor volatility are expected to play an important role in the
dissipation of dicofol.
Ecological Effects
Dicofol is moderately to slightly toxic on an acute basis to terrestrial
animals and slightly toxic to honey bees. Dicofol has also been shown to cause
reproductive effects in avian and mammalian species. For avian species,
laboratory studies suggest that reproductive sensitivity varies greatly, with
raptors apparently the most sensitive. Dicofol is highly to very highly toxic to
all aquatic organisms tested, including fish, invertebrates, and estuarine/marine
organisms.
Ecological Effects Risk Assessment
Acute risks to non-target mammals from exposure to dicofol may occur
for citrus, apples, pears, nuts, and quince uses from exposure to short grass
food sources. Because many small mammal species primarily feed on short
grass, acute hazard from these use patterns is possible. For avian species,
exposure to dicofol in short grass exceeds the Level of Concern (LOG), based
on current uses. Since few if any avian species feed solely or even primarily on
short grass, the acute hazard from this use does not present an unacceptable
risk. ;
Chroniq hazard, in the form of reproductive impairment to mammalian
and avian species, can occur for all currently registered use patterns.
For certain avian species, numerous reproductive parameters may be
adversely affected by exposure to dicofol. Greatest risk appears to be from
citrus. Laboratory data suggest that, for certain avian species, numerous
reproductive parameters may be adversely affected Jby exposure to dicofol,
based on present uses.
In aquatic environments, fresh and salt water fish, shellfish, and
invertebrates are potentially at risk from direct contamination of dicofol to the
Water. Indirect contamination is also a concern
Labeling and other risk mitigation measures recommended in Chapters 4
and 5 of the dicofol RED are sufficient to address these environmental risk
concerns. '"
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Risk Mitigation To address risks to homeowners, residents, and children:
All residential uses have been eliminated from labels and will be
voluntarily canceled.
. To address risks to handlers:
Mixers/loaders/applicators must wear additional personal
protective equipment (PPE), as specified in the labeling specifics in
Chapter 5 of the RED, and use enclosed cabs and cockpits. ,;
I All wettable powder formulations produced after December 31,
1998 must be produced in water soluble packaging (WSP).
i . Application with handheld equipment is eliminated for liquid
: formulations.
Li quid formulations produced after December 31, 1998 must bear
labeling requiring closed jnixing systems for dry beans;
' ' ' To address risks to workers (persons entering treated areas following
applications of dicofol): ,
I A revised REI will be set, based on DFR data being submitted in
' October, 1998, and on a dermal toxicity study being submitted in
December, 1998. .
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, , : To protect the environment and wildlife: ;
... Dicofol applications are limited to no more than one per year.
Previously, for some uses, the number of applications allowed per
year was either unrestricted or limited to 2 or 3 applications per
' ' / '.'- "" year. " " ' ' -. - ' . - '."".'
Dicofol applications ;on citrus will not exceed 3 pounds a.i./acre
- per year. This has beentreduced from 8 pounds a.i./acre per year.
Dicofol applications on strawberries will not exceed 2 pounds
a.i./acre per year. This has been reduced from 2.4 pounds a.i./acre
per year.
Additionally, as a result of previous agreements with the '<
registrants, applications will not exceed:
; '-.' 3 lb ai/acre for apples and pears (reduced from 4 Ib ai/acre);
. 2 Ib ai/acre for pecans and walnuts (reduced from 4 Ib ai/acre);
1.5 Ib ai/acre for cotton (reduced from 1.6 Ib ai/acre);
1.3 Ib ai/acre for grapes (reduced from 1.5 Ib ai/acre);
0,63.Ib ai/acre for cucurbits (reduced from 1.5 Ib ai/acre);
0.75 Ib ai/acre for tomatoes and peppers (reduced from .8 Ib
ai/acre); '
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1.5 Ib ai/acre for stpnefruits,'
1.5 Ib ai/acre for beans; and
0.55 Ib ai/acre for nonresidential lawns and ornamentals.
ป A spray drift and Runoff Caution Statement is being added to the
label. Also, a statement prohibiting application directly to water is
being added to the label.
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Additional Data All dicofol products must comply with EPA's current pesticide product
Required labeling requirements. For a comprehensive list of labeling requirements, see
Chapter 5 of the dicofol RED document.
EPA is requiring the following additional generic studies for dicofol to
confirm its regulatory assessments and conclusions: a UV/visible absorption
study, DFR study, dermal toxicity study, and postnatal developmental
heurotoxicity study in addition to other confirmatory studies listed in Chapter 5
of the dicofol RED.
The Agency also is requiring product-specific data including revised
Confidential Statements of Formula (CSFs) and revised labeling for
reregi strati on. In addition, the Agency is requiring certain confirmatory data,
as detailed in Chapter 4 of the dicofol RED document.
Product Labeling All dicofol end-use products must comply with EPA's current pesticide
Changes Required product labeling requirements. For a comprehensive list of labeling
requirements, please see the dicofol RED document, chapter 5.
Regulatory EPA has determined that products containing dicofol may be eligible for'
Conclusion reregistration, as specified in the dicofol RED, contingent upon results of a
dermal toxicity study due to the Agency in December 1998.
The registrants have agreed to a voluntary cancellation of all dicofol
products, which will go into effect if, after a review of the dermal toxicity
study, MOEs remain unacceptable. In addition, the registrants have agreed to
the risk mitigation measures discussed in the Risk Mitigation section of this
Fact Sheet. Moreover, a restricted entry interval (REI) will be set, based on
the dermal toxicity study and a DFR study to be submitted to EPA in October
1998.
If results of the dermal toxicity study and DFR study show dicofol to be
acceptable, based upon review by the Agency's science peer review
committees and EPA management approval, dicofol products will then be
reregistered once the required product-specific data, revised Confidential
, . Statements of Formula, and revised labeling are received and accepted by EPA.
Products which contain active ingredients in addition to dicofol will be
reregistered when all of their other active ingredients also are eligible for
reregistration.
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. While the current occupational risk assessment indicates possible
unacceptable'risk levels, EPA has found that it is not appropriate to declare
; : ' ' dicofol ineligible at this time. One key consideration is the fact that the
- registrants are submitting a study which may be a more appropriate study for
regulatory purposes but which the Agency has-not yet received. Although the
, Agency would not normally delay a decision for a study voluntarily conducted
by a registrant outside the RED timeframe, two factors make -this appropriate
here. First, the registrants have committed to significant risk mitigation
measures to be implemented immediately. Second, the registrants have
committed to a process that would result in automatic and voluntary
cancellation of any use which continues to, have unacceptable risk after EPA
completes its review of the incoming new study, in a timeframe that is
comparable or more rapid than what EPA could achieve through its own . ."
regulatory process, _
For More EPA is requesting public comments on the Reregi strati on Eligibility
Information Decision (RED) document for dicofol during a 60-day time period, as . ' '
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
, contact the Pesticide Docket, Public Response and Program Resources Branch,
- Field Operations Division -(7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone (703) 305-5805.
Electronic copies of the RED and this fact sheet 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 EPA's
, National Center for Environmental Publications and Information "
(EPA/NCEPI), PO Box 42419, Cincinnati; OH 45242-0419, telephone.(513)
489-8190, fax (513) 489-8695. . ,
Following the comment period, the dicofol RED document also will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone (703) 605-6000.
For more information about EPA's pesticide reregistration program, the
dicofol RED, or reregistration of individual products containing dicofol, please
contact the Special Review and Reregistration Division .(7508C), OPP, US
EPA, Washington, DC 20460, telephone (703) 308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN)- Call toll-free
(800) 858-7378, between 9:30 am and 7:30 pm Eastern Standard Time,
, Monday through Friday.
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ฅ ฉ \
. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOV 25.1998
CERTIFIED MAIL
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 dicofol which includes
the active ingredients l,l-bis(chlorophenyl)-2,2,2-trichloroethanol l-(2-ehlorophenyl)-l-(4-
chlorophenyl)-2,2,2-trichloroeth'anol. The enclosed Reregistration Eligibility Decision (RED).
which was approved on September 30,1998, contains the Agency's evaluation of the data base of
these chemicals, 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 may also include requirements for additional data (generic) on the active
ingredients 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 pesticide law (FD7RA) and the food arid drug 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
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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.
If EPA determines, as a result of this later implementation process, that any of the
determinations described in this 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 Reregi strati on Division representative Venus
Eagle at (703) 308-8045.__ Address any questions on required generic data to the Special Review
and Reregistration Division representative, Phil Budig at (703) 308-8029.
Sincerely yours,
Enclosures
Lois A. JrossY, Director
Special Review and
Reregistration Division
.- v
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (REm
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, 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) with the RED. 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-Nn 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 REREGISTRATION OR "8-MONTH RESPONSE"-Ynn mi.sf
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a- Application for Registration (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.
'..... \ '
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 #PB 92-221811; 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).
d. Two copies of the Confidential Statement of Formula (CSF> for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
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'I'.ll' ' ! , ' ,,,,,, ' : . : "',', '',,' . '
,, ',' I ' '" " ' ''"I . ' ' . ' ' ' '.' .''(.' I ' ', - ' '''''',
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
ง158.175) or (2) 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 ง 158.175(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 IN RESPONSE TO FEDERAL REGISTER NOTICE-Cnmments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Esgister Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES V90-DAY1 AND
ALLIGATIONS FOR REREGISTRATION (8-MONTH RESPONSES^
Bv U.S. Mail! '" ' " ' ! "' ""
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 MSt. S.W.
Washington, D.C. 20460-0001 ซ
By Express:
Document Processing Desk (RED-SRRD-PRB)
Office of pesticide Programs (7504C)
Room 266A, Crystal Mail 2
1921 Jefferso,n Davis Hwy.
Arlington, VA 22202
, T _ ' i 'I' " i " ' i, ' , ' i. , " ""* u ,i
6- งPA>S REVTEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregistration determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
Dicofol
-.' /
LIST A
CASE 0021
ENVIRONMENTAL PROTECTION AGENCY
, OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
DICOFOL REREGISTRATION ELIGIBILITY DECISION TEAM / i
. EXECUTIVE SUMMARY .',............. . . ,.:. . ....'....,... v
I. INTRODUCTION '.,'.', ; . ..... ...... 1
H. CASE OVERVIEW .'.:..:.:'....'.'.'.'..'...'...'.'.'. .'-. ..... . .' /.-.'. ....... 2
A. Chemical Overview ~ .........I.... .... 2
B. Use Profile ..:...,.....: .......:...,. ...... ., . . 2
C. Estimated Usage of Pesticide 4
D. ,Data Requirements ... ... ......:. .'.- .... 9
E. Regulatory History . . 9
HI. SCIENCE ASSESSMENT . . . ... .'..'.. ...,,.. ... 10
A. Physical Chemistry Assessment :......,...:.....,. 10
1. Description of Chemical ... ...'..' 10
2. Identification of Active Ingredient 10
B. Human Health Assessment : H
1. Toxicology Assessment .... . . ..... ... H
a. , Acute Toxicity ..11
b. Subchronic Toxicity . ....:. .', ........;... . . 11
c. Chronic Toxicity/Carcinogenicity 13
d. Developmental Toxicity . . . 14
e. Reproductive Toxicity ...,......;... . .'. . .15
f. Mutagenicity ................... 17
g. Neurotoxicity ... .....: 18
h. Metabolism .18
i. Dermal Absorption ,.'. .... 19
j. Special Studies/Other Tbxicological Considerations ....... 19
2. Dose Response Assessment ........ ... .... 20
a. Determination of Susceptibility to Infants and Children ... 20
, b. Chronic Reference Dose (RfD) .22
c. Carcinogenic Classification 23:
d. Dermal Absorption ...:... 23
e. Summary of Toxicological Endpoints for Use in Human Risk
Assessment ..,.....'..... 24
3. Dietary Exposure and Risk Assessment/Characterization . , 28
a. Registered Food Uses 28-
b. Summary of Science Findings ...........;.....,.... 29
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c. Anticipated Residues . . : 32
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d. Dietary Risk from Food Sources 42
,": " ' .1 ' .." ' I1, ' ; . ." 1 . : i . 1, , ... , , , ' .
e* Dietary Risk from Drinking Water Sources . 43^
4. Occupational and Residential Exposure and Risk Characterization 45
a. Use Pattern and Formulation Summary .....: .45
b. Assumptions 46
c. Occupational Handler (Mixer/Loader and Applicator) Exposure
and Risk Assessment/Characterization .,,......,.....,.,.., 49
d. Occupational Post Application Exposure and Risk Assessment/
Characterization 70
e. Residential and Other Non-Occupational Exposures and
: . Risks . 71
f. Incidence Reports 71
5. Food Quality Protection Act Considerations '. . : 72
/;"" ' ' ";/; a. ; Cumulative Effects'. . .;'..'....'. ..,...,..,.,, 72
b. Endocrine Disrupter Effects 73
c. Special Sensitivity of Infants and Children 73
d. Aggregate Risk 73
C. Environmental Assessment , .... : .................. 74
1. Exposure Characterization 74
a. Environmental Fate Assessment . .74
b. Terrestrial Exposure Assessment 78
c. Water Resource Assessment 80
d. Aquatic Exposure Assessment , 82
2. Ecological Effects .Characterization . . . 83
a. Toxicity to Terrestrial Animals 84
b. Toxicity to Aquatic Animals 88
c. Toxicity to Plants 91
3. Environmental Risk Assessment . 91
a. Exposure and Risk to Nontarget Terrestrial Animals 94
b. Exposure and Risk to Nontarget Freshwater and Marine Aquatic
i-:1' ." ; "; -. ;' , ; -' Animals '. . ....,.._.,..... ....-..-,.,., '. .... 98 ...
c. Exposure and risk to Endangered Species . . 102
4. Risk Characterization 102
a. Environmental Fate and Exposure Assessment 102
b. Environmental Hazard Assessment . 104
c. Environmental Risk Assessment,.. . , - 104
d. Comparison of Dicofql to DDT and DDE 106
e. Inferences from Field Monitoring Studies 107
TV, RISK MANAGEMENT AND REREGISTRATION DECISION !.....! 107
A. Determination of Eligibility ..... .............. io7
B. Determination of Eligibility Decision 108
C. Regulatory Position 109
1. Tolerance Reassessment . . .. Ill
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2. Tolerance Revocations and Import Tolerances Ill
3. Codex Harmonization .... ... . . . , ....... 119
4. Food Quality Protection Act Findings . . .. ...... ... 122
a. Determination of Safety for U.S. Population . . 122
b. Determination of Safety for Infants and Children . . 122
5. Summary of Risk Management Decisions ....... ... 123
a. Human Health .... ; 123
b. Environmental . . . ........ 124
6. , Occupational Labeling Rationale/Risk Mitigation ....;......, 127
a. The Worker Protection Standard 127
b. Requirements for Handlers f ......; 127
c. Homeowner Use Products 128
d. Post-Application Entry restrictions .. ..... ... . . . 128
e. Other Labeling Requirements .-...,.' 129
7. Restricted Use Classification ... 129
8. Endangered Species Statement ... ... . . . . . . . ... . . ... .,.'. .129
9. Spray Drift Advisory ........... ...-.'.-.'... 129
V. ACTIONS REQUIRED OF REGISTRANTS AND OTHERS 130
A. Manufactured Use Products .... 130
1. Additional Generic Data Requirements 130
2. Labeling Requirements for Manufacturing Use products ....... 131
B. End Use Products.. . . . . . . . .... 131
1. Additional Product Specific Data Requirements . . . . 131
2. Labeling Requirements for End Use Products . . ; . '. 132
C. Existing Stocks ^ 143
VL APPENDICES ..../. . . :.,:.'.. .... ;'...'. . /. ". . . . .'. . . ]45.
A. Table of Use Patterns Subject to Reregistration . . . ... ....... 146
B. Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision ......... . .......... 147
C. Citations Considered to be Part of the Data Base Supporting the Reregistration
Decision \ง\
D. Combined Generic and Product Specific Data Call-In . . . 197
1. Chemical Status Sheets 217
2. Combined Generic and Product Specific Data Call-in Response Forms
(Insert A) Plus Instructions 219
3. Generic and Product Specific Requirement Status and Registrant's
Response Forms (Insert B) and Instructions . . 223
4. EPA Batching of End-Use Products for Meeting Data Requirements for
Reregistration . . 230
5. List of All Registrants Sent This Data Call-In (insert) Notice ....233
E. List of Available Related Documents and Electronically Available Forms 23 5
-------
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DICOFOL REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
John Faulkner
Mike Hennessey
Economic Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Risk Assessment
Nelson Thurman
Nicholas FederofF
Richard Felthousen
Jose Luis Melendez
Health Effects Risk Assessment
Mary Rust
Whang Phang
Stephen Funk
Alan Nielsen
Robert Travaglini
- Tim Leighton
Registration Support Risk Assessment
Leonard Cole
Risk Management
Dan Helfgott
PhilBudig
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Risk Characterization and Analysis Branch
Toxicology Branch II
Reregi strati on Support Chemistry Branch
Reregi strati on Branch II
Risk Characterization arid Analysis Branch
Chemistry and Exposure Branch
Insecticide-Rodenticide Branch
Special Review Branch
Special Review Branch
-------
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-------
GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.,
ARC
CAS
CI
CNS
CSF
DFR
ORES
DWEL
DWLOC
EEC
EP
EPA
FAO/WHO
FDA
FIFRA
FFDCA
FQPA
FOB
GLC
GM
GRAS
HA
HOT
IR4,
LC50
LD,
LDlo
LEL
LOAEC
LOAEL
LOG
LOD
LOEL
MATC
MCLG
Hg/g
,wg/L
mg/L'
Acceptable Daily Intake. A now defunct term for reference dose (RfD). "
Acid Equivalent
Active Ingredient "
Anticipated Residue Contribution - x , .
Chemical Abstracts Service
Cation , .
Central Nervous System
Confidential Statement of Formula
bislodgeable Foliar Residue . .
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur. , - v
Drinking Water Level of Comparison
Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem. ,
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization/World Health Organization , .
Food and Drug Administration
Federal Insecticide, Fungicide, and'Rodenticide Act
. Federal Food, Drug, and Cosmetic Act " , , ,
Food Quality Protection Act
Functional Observation Battery ' . '
Gas Liquid Chromatography
Geometric Mean / ' '-'..-',
Generally 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 ' .
Interregional Research Project No. 4
Median Lethal Concentration, 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 can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, 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 / . - .
Lowest Observed Adverse Effect Concentration
Lowest Observed Adverse Effect Level
Level of Concern " , , /
Limit of Detection
Lowest Observed Effect Level .
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The 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
ill
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
MOE
MP
MPI
MRID
N/A
NOAEC
NO AEL
.I11' ..... .
NOEC
NPDES
NOEL
OPP
Pa
PAD!
PAP
PAlM
PHED
PHI
ppb
PPE
ppm
PRN
Q",
RBC
RED
REI
RiD
RS
RUP
SLN
TC
TD
TEJP
TGAI
TLC
TMRC
torr
WP
WPS
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
No Observed Adverse Effect Concentration
No Observed Adverse Effect Level
i ...... ,[ " ' .......... ' : . f . I , 'i ,f. .
No Observable Effect Concentration
National Pollutant ^Discharge Elimination System
No Observed Effect Level ' ',',', ' . ' . ...... ' . , '. .
No OJ3seryed 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
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
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval . '
Reference Dose
Registration Standard
Restricted Use Pesticide
Special Local Need (Registrations Under Section 24 ฉof FIFRA)
Toxic Concentration. The concentration at which a substance produces a toxic 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.
Wettable Powder
Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency (hereafter referred to as "the Agency") has
completed its reregistration eligibility decision of the pesticide active ingredient l,l-bis(4-
chlorophenyl)-2,2,2-trichlorpethanol and l-(2-chlorophehyl)-l-(4-chlorophenyl)-2,2,2-
trichloroethanol, also known as dicofol. This reregistration decision includes a comprehensive
reassessment of the required data and use patterns of currently registered products. Dicofol is a
miticide used for foliar application to a variety of food/feed crops. End use products registered for
use on food/feed crops include emulsifiable.concentrates (EC), wettable powders (WP), a flowable
concentrate (FIC), and a wettable powder/dust (WP/D) that may be applied as dilute or concentrated
ground or aerial sprays. , ,
This reregistration decision considered the requirements of the "Food Quality Protection Act
of 1996" (FQPA) which amended the Federal Food Drug and Cosmetic Act and the Federal
Insecticide Fungicide and Rodenti tide Act, the two Federal statutes that provide the framework foY
pesticide regulation in the United States. FQPA became effective immediately upon signature and
all reregistration eligibility decisions (REDs) signed subsequent to August 3, 1996 are accordingly
being.evaluated under the new standards imposed by FQPA. , '
In establishing or reassessing tolerances, FQPA requires the Agency to consider aggregate
exposures to pesticide residues, including all anticipated dietary exposures and other exposures for
which there is reliable information, as well as the potential for cumulative effects from a pesticide and
other compounds with a'common mechanism of toxicity. The Act further directs EPA to consider
the potential for increased susceptibility of infants and children to the toxic effects of pesticide
residues, arid to develop a screening program to determine whether pesticides produce endocrine
disrupting effects.
In summary, based on the data reviewed by EPA, dicofol does not present an acute or chronic
dietary risk to the U. S. populations at large, or any subgroups. This analysis includes the contribution
from food and water. The agency has determined that dicofol may present serious concerns in
occupational and residential settings. The toxicity endpoint of concern in these settings is hormonal
toxicity (inhibition of ACTH stimulated cortisol). The Agency has also determined that dicofol may
present an ecological risk. ,. ,
However, the Agency believes that the default assumptions used in the occupational risk
' assessmentmay haveledto an overestimation of that risk (i.e. the default assumption of 100% dermal
absorption and an initial Dislodgeable Foliar Residue (DFR) level at 20% of the application rate and
assuming residue dissipation of 10% per day). To improve our estimation of dicofol occupational
risk, the registrants have initiated a dermal toxicity study,, which is due to the Agency on December
31, 1998. In addition, as a result of a Data Gall In from October 13, 1995, the registrants are also
completing a DFR study; due in October, 1998. These data will be used to develop revised margins
of exposure (MOE) and restricted entry intervals (REI). In the interim, while this data is being
developed and evaluated, the registrants have also agreed to undertake several risk mitigation
measures to .address the occupational risks identified in this RED (described below and in Chapters
v
-------
IV and V), Additionally, to address the Agency's residential and ecological 'risk concerns, the
registrants have agreed to voluntarily cancel residential uses of dicofol and to adopt ecological risk
mitigation.
The Agency will conclude that dicofol is eligible for reregi strati on if, after consideration of
dermal toxjcity data submitted by the registrants, the revised MOEs are found to be acceptable (i.e.,
MOEs above 100). The registrants have submitted a request to voluntarily cancel all uses/products
which are found to have unacceptable MOEs after consideration of the new data and if risks cannot
be mitigated to acceptable levels.
While the registrants' DFR and dermal exposure studies data are being developed, the
following interim measures have been taken, or will be taken, to reduce risk from dicofol to humans
and the environment:
1. All residential uses have been deleted from labels and will be voluntarily canceled.
2. Mixer/loader/applicators will be required to wear additional personal protective
equipment (PPE) and use enclosed cabs and cockpits.
3. Application with handheld equipment is eliminated for liquid formulations.
d. All wettable powder formulations produced after December 31, 1998 must be
produced in water soluble packaging (WSP)
e. Liquid formulations produced after December 31,1998 must bear labeling requiring
closed mixing systems for dry beans.
f. Applications of dicofol will be limited to no more than one per year. Previously, in
sortie uses, the number of applications allowed per year was either unrestricted or
1 lifted to two or three applications per year.
7. Citrus application levels have been reduced from 8 Ibs. a;i. per acre to 3 Ibs. a.i. per
acre. Further reductions will be made, if required, based on the results of the ongoing
dermal study, within one year of the publication date of this RED.
8. Application rate for wettable powders on strawberries has been reduced to 2 Ibs. a.i.
per acre, reduced from 2.4 Ibs. a.i. per acre.
9. A spray drift and Runoff Caution Statement is being added to the label. Also, a
statement prohibiting application directly to water is being added to the label.
* - ' '. -
While the current occupational risk assessment indicates possible unacceptable risk levels,
EPA has found that it is not appropriate to declare dicofol ineligible at this time. One key
consideration is the fact that the registrants are submitting a study which may be a more appropriate
study for regulatory purposes but which the Agency has not yet received. Although the Agency
would not normally delay a decision for a study voluntarily conducted by a registrant outside the RED
t'mฎframe'two factฐEs make this appropriate here. First, the registrants have committed to significant
risK rhitigation measures to be implemented immediately. Second, the registrants have committed to
a process that would result in automatic and voluntary cancellation of any use which continues to
have unacceptable risk after EPA completes its review of the incoming new study, in a timeframe that
is comparable or more rapid than what EPA could achieve through its own regulatory process.
VI
-------
Before reregistering the products containing dicofol, 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. Additionally, except for cases where the basic registrants have
made commitments for label changes in 1999, revised labeling must also be submitted within eight
months of the issuance of this document. , After reviewing these data and any revised labels and
finding them acceptable in accordance with Section 3(c)(5) of FDFRA, the Agency will reregister a
product. Those products which contain other active ingredients will be eligible for reregistration only
when the other active ingredients are determined to be eligible for reregistration.
vn
-------
-------
I. INTRODUCTION
In'1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,1984.
The amended Act provides a schedule for the reregi strati on process to be completed in nine years.
There are five phases to the reregi strati on 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") of all data submitted to support
reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator 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 underlying a pesticide's
' registration. The purpose of the Agency's review is to reassess the potential hazards arising from the
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 President signed the "Food Quality Protection Act of 1996" (FQPA)
(Public Law 104-170), which amended the Federal Food Drug and Cosmetic Act (FFDCA) and the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Among other things, the FQPA
requires the Agency to consider the special sensitivity, of infants and children to a pesticide, aggregate
exposure of a pesticide from dietary, drinking water, and non-occupational exposures, and cumulative
effects from other compounds with a common mode of toxicity when establishing or reassessing
tolerances. As a result, EPA is embarking on an intensive process, including consulting with
registrants, States, and other interested stakeholders, to make decisions on the new policies and
procedures necessary for implementation of FQPA, This process will include a more in-depth analysis
of the new safety standard and how it should ^be applied to both food and non-food pesticide
applications. However, FQPA did not amend any of the existing reregistration deadlines in Section
4 of FIFRA. Therefore, the Agency will continue its ongoing registration program while it continues
to determine how best to implement the FQPA.
This document presents the Agency's decision regarding: the reregistration eligibility of the
registered uses of dicofol. The document consists of six sections.
Section I is the introduction. , .
Section II describes dicofol, its uses, data requirements and regulatory history.
Section HI discusses the human health and environmental assessment based on the data
available to the Agency. - '- . , - .
Section IV presents the reregistration decision for dicofol.
Section V discusses the reregistration requirements for dicofol. '
Section VI contains the Appendices which support this Reregistration Eligibility Decision.
Additional details concerning the Agency's review of applicable data are available on request.
' I .''.' . ,''-
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H, CASE OVERVIEW
A. Chemical Overview
Dicofpl is a member of the prganochlorine class of pesticides. Other members of this class
include DPT, methoxychlor, chlorobenzilate, and ethylan. Less closely related members of the class
include Hndane, dieldrin, endrin, chlordane, heptachlor, aldrin, endosulfan, kepone, and toxaphene
(George W. Ware, Fundamentals of Pesticides, Thomson Publications, 1982).
'. f ,"' /" ' ; .($ ';." .. ...... i ' ,. '. :. ,''' "''";::;'; ', ', v "(.. , ;'' ; ;'. fc;A .' ','" < .'.' '' . ':' '
The following active ingredient is covered by this Registration Eligibility Decision (RED).
r
Common Name:
Chemical Name:
, ... , . , . ..,
dicofol
l,l-bis(chlqrophenyl)-2,2,2-trichloroethanol
- l-(2-chlorophenyl)-i-(4-chlorophenyl)-2,2,2-
trichloroethanol
Chemical Family: organochlorine
CAS Registry Number: 115-32-2
'',.... OPP Chemical Code: .010501 , , \ ". '" ...... ' ,' "' .' ' .';'''.' " ''
Empirical Formula: C^HgClsO
Trade and Other Names: Kelthane
,i; ' - . ........ ' . . 'i.. , , , ' , - i .', ,: V" !' ,','' ',,'".
Basic Manufacturers: Rohm and Haas Company and Makhteshim-Agan
B. Use Profile
The following is information on the currentiy registered uses with an overview of use sites and
application methods. A detailed table of the uses of dicofol is in Appendix A
Use Sites:
Terrestrial Food/Feed Crops
-Apple; Apricot; Beans; Beans, dried-type; Beans, succulent (lima);
Beans, succulent (snap); Bermuda grass; Blackberry; Bpysenberry;
Cherry; Chestnut; Citrus fruits; Cotton; Crabapple; Cucumber;
Dewberry; Filbert (hazelnut); Grapefruit; Grapes; Hickory nut; Hops;
Kumquat; Lemon; Lime; Loganberry; Melons; Melons, cantaloupe;
Melons, musk; Melons, water; Mint/peppermint/spearmint; Nectarine;
-------
Orange; Peach; Pear; Pecan; Pepper; Plum; Prune; Pumpkin; Quince;
Raspberry (black, red); Squash (all or unspecified); Squash (summer);
Squash (winter); Strawberry;. Tangelp; Tangerines; Tomato; and
Walnut (English/black). ' '
Terrestrial Non-Food
Christmas tree plantations, nonagricultural outdoor buildings and
structures, ornamentals . ".
Greenhouse Non-Food
Ornamentals ' . /
Greenhouse Food Crop
Cucumber
Indoor Food ,
Agricultural farm premises, nonagricultural outdoor buildings and
structures ,
Target Pests .
Dicqfol is used to control numerous species of mites feeding on or
found on the above listed sites. .
Formulations Types Registered
- Technical grade; dust; emulsifiable concentrate; flowable concentrate;
wettable powder
Method and Rate of Application
Method- Dip treatment; Dust application; High volume spray
(dilute); Low volume spray (concentrate); Outdoor
general surface spray; Spot treatment
Equipment- Fixed wing aircraft; Dip tank; Duster; Groundboom;
Helicopter; High volume ground sprayer; Low volume
ground sprayer; Low volume sprayer; Power sprayer;
Sprayer; Tank-type sprayer
-------
Foliar; Nursery stock; Preharvest; Postharvest; When
needed
Rates- see Appendix A
C Estimated Usage of Pesticide
Based on available pesticide survey usage information for the years of 1987 through 1996,
total annual domestic agricultural usage of dicofol averaged about 860,000 pounds active ingredient
(a.i.) for about 720,000 acres treated. Most of the acreage is treated with 2 pounds a.i. or less per
application, and the average acre is treated with about 1.2 pounds a.i. per year. Fruits tend to have
the highest application rates.
'"' :' "!i n , ' , .. " i ' ; '' ', ' , ,,i ' , '>."' , , ", '' ' '' ' " , ' ' " f' ' :,'
: " ' ''ft.! ' ''' , " , i, ป " ' ' ' '','." \ * ', ! '' ',:'!'., ,''' ' , ' '' , ' , ,, ', i' / li'1'
The largest markets for dicofol in terms of total pounds active ingredient are cotton (over
50%) and citrus (almost 30%). Although only about 4% of the cotton acres grown are treated with
dicofol, over 60% of all crop acres treated with dicofol are cotton acres. The remaining usage is
primarily on other fruits and vegetables. Most of the usage is in California and Florida.
Registered nonagricultural sites not listed above nor included in the table below are not
covered by EPA data sources. Registered crops not covered by EPA data include crabapples, quinces,
and tea,
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D. Data Requirements >
, Data requested in the December 30, 1983, Registration Standard for dicofol include studies
on product chemistry, residue chemistry, environmental fate, toxicity, and ecological effects/ These
data were required to support.the uses listed in the Registration Standard. Appendix B includes all
data requirements identified by the Agency for currently registered uses needed to support
reregistration. .-_' -
E. Regulatory History
Due to environmental concerns resulting from the presence of dichloro-diphenyl-trichloro-
ethane (DDT) and related contaminants (DDTr) in dicofol, a Dicofol Special Review was initiated
in 1984. As specified in the Dicofol PD 4 (Notice of Intent to Suspend) dated May 29, 1986,
registrations for dicofol-containing uses faced cancellation, unless the upper limit for DDTr was
certified at 2.5% of diqofol technical by January 1,1986 and at 0.1% by July 1,1987. The Rohm and
Haas 80% T'(EPA Reg. No. 707-107), for which data were reviewed in the Dicofol Guidance
Document dated 1983, was canceled (June 29, 1986) because the product did not comply with the
Dicofol PD 4 requirements concerning DDTr impurity levels. Rohm and Haas subsequently
registered (August 5,1987) the current Kelthaneฎ 95.3% T which contains DDTr impurities at 0.1%.
Makhteshim-Agan fulfilled data requirements for the 88% T containing >1% DDTr. However, no
data have been provided reflecting a reduction of DDTr impurities to 0.1%. It was concluded in
subsequent Agency reviews that product chemistry data submitted by Rohm and Haas will satisfy data
requirements for the Agan product (CBRS No. 11668, D189942, dated April 28, 1993, by S. Funk).
Although the Guidance Document required additional generic and product-specific product
chemistry data for dicofol reregistration, new product chemistry data were necessary for compliance
with the DDTr requirements of the Dicofol PD 4. The 1991 Dicofol Reregistration Standard Update
summarized data which had been submitted in response to the Guidance Document and the Dicofol
PD 4 and which had been reviewed by the Agency. Additional data were required for the Rohm and
Haas 95.3% T (EPA Reg. No. 707-203) concerning GLNs 61-1, 61-2, 63-2, 63-4, 63-5, 63-13, 63-
14, 63-17, and 63-20. All new product chemistry data were required for the Agan 88% T (EPA Reg.
No. 11603-26) because the existing database supported a product containing >0.1% DDTr impurities.
Data remain outstanding for 63-14, 63-15, 63-16, and 63-19. All these data are considered
confirmatory. , . , ,
A Data-Call-in (DCI) fpr chemical-specific post-application exposure and/or environmental
fate data (as regulated by Series 875.2100, 875.2400, and 875.2500) was issued October 13, 1995,
and is due in October 1998. In lieu of these data, a surrogate range-finder post-application exposure
assessment was performed for occupational or residential settings.
-------
m. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Additional data are required for the following product chemistry guidelines for dicofol:
,830.1550; 830.6314; 830.6315; 830.6316; 830.6319; 830.7050. These data requirements are
considered confirmatory.
All generic data requirements are fulfilled for the Rohm and Haas TGAI. However, product-
specific data gaps exist for the Rohm and Haas and Agan MPs. Provided that the registrants either
cer|ify that the suppliers of starting materials and the manufacturing process for the dicofol products
have not changed since the last comprehensive product chemistry review or submit complete updated
product chemistry data packages, the Agency has no objections to the reregi strati on of dicofol with
respect to product chemistry data requirements.
1. Description of Chemical
Dicqfol [l,l-bis(4-chlorophenyl)-2,2,2-trichloroethanol and l-(2-chlorpphenyl)-l-(4-
chlprophenyI)-2,2,2-trichloroethanol] is a miticide used on terrestrial food crops and non-food sites.
Dicofol is structurally similar to DDT. Dicofol differs from DDT by the replacement of the hydrogen
(H) on C-l with hydroxyl (OH).
o, p'-dicofol
Cl CC13
p, p'-dicofol
CCL
Empirical Formula:
Molecular Weight:
CAS Registry No.:
Shaughnessy No.:
370.5
115-32-2
010501
, , , , , , [, , , ,
2. Identification of Active Ingredient
Technical dicofol is a reddish-brown, extremely viscous nonfree-fiowing liquid with a vapor
pressure of about 4.0 x 10'7 mm Hg at 25ฐ C. Dicofol is soluble in organic solvents
(dichloromethane, methanol, n-heptane, andxylene) and relatively insoluble in water (~ 1 ppm for the
PA!). M " ' ^ i ; . ' ,
10
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B. Human Health Assessment ,
' . / , - t .
1. Toxicology Assessment
The lexicological data base on dicofol is adequate to support refegistratiorveligibility:
a. ; Acute Toxicity
The following table summarizes the acute toxicity values and categories for technical dicofol.
Table 2: Acute Toxicity of Technical Dicofol.
TEST ' ." '
Oral LD50 - Rat
Dermal LD50 - Rabbit
Inhalation LC50 - Rat
Eye Irritation - Rabbit -
Dermal Irritation- Rabbit
Dermal Sensitizati on - Guinea pig
RESULTS,
587 mg/kg
2 - 5 g/kg
>4.2 mg/L
Moderate irritation
Moderate irritation
Not sensitizing
CATEGORY
III
III
IV
III
III "
NA
Based on a LD50 value of 587 mg/kg in CRCD rats, dicofol was placed in Toxicity Category
HI for acute oral toxicity (guideline 81-1; MRID 40731204).
An acute dermal toxicity test with CRCD rats reported the dermal LD50 to be greater than 5.0
g/kg, placing dicofol in Toxicity Category TV for dermal toxicity (guideline 81-2; MRID40731205).
When tested in New Zealand white rabbits for dermal toxicity, the LD50 was between 2 and 5 g/kg,
placing dicofol in Toxicity Category IE (guideline 81-2; MRID 40731205). , .
The acute inhalation LC50 was greater than 4.2 mg/L in one study and greater than 5 mg/L in
another study. Based on these results in rats, dicofol was placed in Toxicity Category IV (guideline
81-3; MRID 00256514; 40731202). . ..-,'.
A primary eye irritation study with rabbits indicated dicofol to be a moderate eye irritant,
placing it in Toxicity Category m (guideline 81-4; 256589). A primary dermal irritation study in
rabbits showed dicofol to be a moderate irritant, placing it in Toxicity Category IE (guideline 81-5;
25'6589). Dicofol was shown to be a non-sensitizer in guinea pigs (guideline 81-6; MRID 40048506).
b. Subchronic Toxicity
In a subchronic, oral toxicity study in rats, groups of Crl:CD (SD)BR rats (10/sex/dose)
received dicofol at dietary concentrations of 1,10,100, 500, and 1,500 ppm for 90 days (0.07, 0.64,
6.49, 32.01, and 95:84 mg/kg7day for males, and 0.08, 0.78, 7.84, 36.11, and 105.91 mg/kg/day for
females, respectively). The controls received an untreated diet. Under the conditions of the study,
11
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dicofol produced a wide range of effects in both sexes of rats. At 1,500 ppm dicofol produced death
and clinical signs such as lethargy and ataxia prior to death. Reduced body weights and food
consumption were seen in 500 and 1,500 ppm rats of both sexes. 'Most of the other effects were
associated with toxjcity seen in the liver (increased liver weights, enhanced hepatic Mixed Function
Oxidase (MFO) activity, and hepatocellular hypertrophy), adrenals (diffuse adrenal cortical cell
vacuolation and decreased corticosterone levels), thyroid (hypertrophy of the thyroid follicular
epithelium), and stomach (focal chief-cell hyperplasia in the fundic mucosa). Effects on the liver and
thyroid were seen in dose levels as low as 100 ppm and 10 ppm, respectively. However, at 1 ppm,
dic,ofol did not produce an effect in any of the parameters examined in this study. The NOAEL was
1 ppm (0,07 mg/kg) and the LOAEL was 10 ppm (0.64 mg/kg), based on an increase in the incidence
of hypertrophy of the thyroid follicular epithelium (MRID No.47015801).
This study is classified as acceptable and satisfies the data requirements for a subchronic
feeding study in rodents (Guideline No. 82-la). The Registrants, however, are requested to submit
data on the analyses of the tissue residues of the test compound.
In a 90-day feeding study in mice, groups of Crl:CDR-l (ICR) BR mice (10/sex/group) were
fed diets containing dicofol at concentrations of 10, 125, 250, 500, or 1000 ppm (1.6, 18.2, 38.2,
84.4? or 178.4 mg/kg for males and 2.1,29.3,56.2,108.0, or 188,4 mg/kg for females, respectively)
for J3 weeks. Under the conditions of this study dicofol did not produce any compound-related
effects in 10 ppm male or female mice. Dicofol produced dose-related effects on the body weights,
the liver (increased liver weights, hepatic MFO activity, hepatocellular hypertrophy associated with
necrosis and vacuolation), kidney (decrease in weight, granular and dilated kidneys, dilation and
degeneration of cortical tubules of kidneys), and the adrenal glands (diffuse hypertrophy of adrenal
cortical cells), at dose levels as low as 125 ppm, 250 ppm and 500 ppm, respectively. Effects seen
in i,000 ppm were more severe than any lower dose levels. The NOAEL was 10 ppm (1.6 mg/kg)
and the LOAEL was 125 ppm (18.2 mg/kg) based on a decrease in body weights, increased hepatic
MJ|O activity, and an increase in liver weights (MRID No. 40042044).
'''"' | '. ''''.' ' , ' ' ' . '.'' .' ' ' , ,. ' !"! '" ' ' ,'", .'. '' ' '
This study is classified as acceptable, although a subchronic feeding study in mice is not
required.
f':r ' ' 'Oi'i . .'''' , , ' . ''' (i .,,',' " ; 'if""" ' ,' ' i " '
In a subchronjc oral toxiciry study in dogs, groups of beagle dogs (6/sex/dose) received dicofol
at dietary concentrations of 0,10, 100, 300, or 1,000 ppm (0, 0.29, 3.3, 9.9, or 26 mg/kg for males
and 0. 0.31, 3.4, 9.8, or 27 mg/kg for females) for three months. The NOAEL was 10 ppm (0.29
mg/kg/day) and the LOAEL was 100 ppm (3.3 mg/kg/day), based on a decrease in cortisol release
in response to adrenocorticotropic (ACTH) administration, an increase in relative liver weights, and
oligpspermatogenesis in males. There were effects also on survival, testes, prostate, liver,
gastrointestinal tract, and heart at the LOAEL and higher doses OvflUD No.40042043).
This study is classified as acceptable and satisfies the data requirements for a subchronic
feeding study in non-rodents (Guideline No. 82-lb).
12
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In a 28-day dermal toxicity study, groups of CD rats (6/sex/dose) received repeated dermal
applications of dicofol (44.8%) at doses of 0 (water control), 0 (formulation-blank), 1.0, 2.5,4.0, and
40.0 mg a.i./kg, 6 hours/day, 5 days/week for 4 weeks. Each animal received 1 ml/kg of the test
article. Under conditions of the study,, dicofol did not produce a treatment-related increase in clinical
signs or mortality, and did not affect food consumption, hematology, and clinical chemistry
parameters. Dicofol produced a slight decrease in body weights and body weight gains in the highest
dose males and an increase in the incidence of hepatocellular centrilobular hypertrophy. The increase
in the incidence of liver hypertrophy in 40.6 mg/kg rats could be considered as an adaptive effect,
while the slight decrease in body weights and body weight gains appeared to be equivocal results.
Under conditions of this study, the highest dose (40 mg a.i./kg) could be conservatively considered
as the NOAEL was 4.0 mg/kg/day and the LOAEL was 40.0 mg/kg/day (MRID No.44099201).
In a 28-day dermal toxicity study (MRID No. 41077001), groups of New Zealand white rabbits
(6/sex/dose) received repeated dermal applications of Kelthane MF miticide (43.6% a.i) at doses of
0 (water control), 0 (formulation control), 4.1, 10.2, or 61.1 mg a.i./kg, 6 hours/day, 5 days/week
for 4 weeks. The test material caused dermal irritation at all dose level including the water control.
The degree of dermal irritation and incidences of acanthosis and hyperkeratosis in treated skin were
similar in the formulation control and in the high dose animals. Therefore, the dermal irritation was
attributed to the formulation vehicle. Systemic toxicity was manifested as statistically significantly
decreased body weight in males at the mid and high doses and in females at the high dose. For
systemic toxicity, the NOAEL of 4.1 mg/kg/day and the LOAEL was 10.2 mg/kg/day
These studies are classified.as acceptable and satisfy the data requirements for 21 -day dermal
toxicity study (Guideline No. 82-2). .
c. Chronic Toxicity/Carcinogenicity
In a one-year chronic toxicity study in dogs, groups of beagle dogs (6/sex/dose) were fed diets
containing dicofol (93.3%) at doses of 0, 5,30, or 180 pprri for 52 weeks. These doses corresponded
to 0, 0.12, 0.82, or 5.71 mg/kg for males, and 0, 0.13, 0.85, or 5.42 mg/kg for females, respectively.
The NOAEL was 5 ppm (0.12 mg/kg/day in males and 0.13 mg/kg/day in females), and the LOAEL
was 30 ppm (0.85 mg/kg/day in females and 0.82 mg/kg/day in males), based on inhibition of ACTH-
stimulated cortisol release in both sexes. There was increased mortality, increased alkaline
phosphatase levels, increased liver weights, and hepatocyte hypertrophy in males and females at the
high dose (MRID 40997101).
This study is classified as acceptable and satisfies the data requirements for a chronic feeding
study in non-rodents (Guideline No. 83-1). -- .
In a chronic toxicity/carcinogenicity study in rats, groups of CRL:CDR BR rats (60/sex/dose)
received dicofol at dietary levels of 0, 5, 50, or 250 ppm (0, 0.22, 2.23, or 11.34 mg/kg/day for
males and 0.27, 2.69, or 14.26 mg/kg/day for females, respectively) for 24 months. For chronic
toxicity, the NOAEL was 5 ppm (0.27 mg/kg/day in females, 0.22 mg/kg/day in males), and the
LOAEL was 50 ppm (2.69 mg/kg/day in females, 2.23 mg/kg/day in males), based on decreased food
' - ' '- - . ' 13 ' - , ' ' ,
-------
consumption, decreased body weight gain, reduced triglyceride levels, and increased hepatic mixed
function oxidase activity, seen at or before 12 months. There were also histpipgical changes: the liver
showed centrilobular hepatocyte hypertrophy, vacuolation, and areas of necrosis in 50 and 250 ppm
majeง and females, and the adrenal glands showed cortical cell vacuolation in 250 ppm males and
females. No compound-related increases in tumor incidence were observed in this study (MRID
Na41150001).
' , 'I 'I ซ ,f * ' ,1 " "' ,| , ,'il ' .' '" i ' ' , , " . u .,,''.,: ' ' , ,, ' ,'',' ' " " ' 1", ,
This study is classified as acceptable and satisfies data requirements for a chronic
feeding/carcinogenicity study (Guideline No. 83-5).
Carcinogenic bioassays of dicofol were also carried out by the National Cancer Institute in rats
and.mice1. In the rat study, groups of Osborne-Mendel rats (50/sex/dpse; control, 20/sex) were fed
0, |7lr or 942 ppm (equivalent to 0, 23.6 or 47.1 mg/kg/day) in males and 0, 380, or 760 ppm
(equivalent to 0, 19, or 38 mg/kg/day) in females for 78 weeks, followed by 34 weeks without
treatment. Dose-related body weight depression was found in both sexes. No compound-related
tujnprs; were obseryed at either dose (MRID 41037801).
I , "I' 5'iil!; '!.'" ,/V!; , ' ' . . ' ' ':i', ;_ fr , ' , (.'. . , /. ,; ' ,; .. ,': . . '!;;';. , . . " _. ; , , ' . ^ , . " ''
Jn the NCI mopsecarcinogenicity study, groups of B6C3F1 mice (50/sex/dose; control, 20/sex)
weje given dicofol at dietary concentrations of 0, 264, or 528 ppm in males (equivalent to 0, 39.6,
or |9,2 mg/kg/day) and 0, 122, or 243 ppm (equivalent to 0, 18.3 or 36.5 mg/kg/day) in females for
45;jveeks, followed by 14-15 weeks without treatment. High dose females had decreased body
weights. Incidences of hepatocellular adenomas and hepatocellular adenomas/carcinomas combined
were significantly increased in males at both dose levels (39.6 and 79.2 mg/kg/day) (MRID
41Q37801).
d. Developmental Toxicity
v ', '':" '.' ,;,"!' :.;'-' ','.-:-.'',',:': I', ' .,-: ' ;'.,,.,/: :''.':, .'ฃ* ''".":'" ''''/";;:' ''- -.''.
In a developmental toxicity study in rats, groups of pregnant Crl:COBS CD rats (25/dose
group) received oral administration of dicofol (95.6%) at doses of 0, 0.25, 2.5, or 25 mg/kg/day on
gestation days 6-151 For maternal toxicity, the NOAEL was 0.25 mg/kg/day, and the LOAEL was
2,5 mg/kg/day base3 on salivation, reduced food consumption and body weight gain, and increased
relative liver weight accompanied by centrilobular hepatocyte hypertrophy. No developmental
toxicity was observed. For developmental toxicity, the NOAEL was greater than 25 mg/kg/day
(MRID 40042046). The lack of developmental toxicity seen in this study is also confirmed by the
results of a published developmental toxicity study in normal and malnourished pregnant Wistar rats
exposed to dicofol at 10 mg/kg/day on gestation days 4 to 15 (Lemonica et al., 1993).
.UK " i]"'1.!' . " '' . '''';ง' ', '' ,""' 'll1'1' ',",'' '! '"'' ' '. '.' ,.'T" ''" ' ' '.' I '"' ,i ', !, "'*';;,' ' ' ' ซ ''',, '^ ' ' '"
! This study is classified as acceptable and satisfies the data requirements for a prenatal
developmental toxicity study in rats (Guideline No. 83-3a).
I The dietary concentrations for the NCI rat and mouse carcinogenicity studies (discussed below)
Indicate time-weighted concentrations.
14
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In a developmental toxicity study in rabbits, groups of artificially inseminated New Zealand
white rabbits (20/dose group) received dicofol (95.6%) by gayage at doses of 0, 0.4, 4, or 40
mg/kg/day on gestation days 7-19, For maternal toxicity, the NOAEL was 4 mg/kg/day and the
LOAEL was 40 mg/kg/day, based upon findings of abnormal feces,, reduced food consumption and
body weight gain, and increased relative liver weight associated with hepatocyte cytoplasmic
hyalinization and vacuolation. For the developmental toxicity, the NOAEL was 4 mg/kg/day and the
LOAEL was 40 mg/kg/day, based on an increased incidence of abortions in the does (MRID No
40042047). '
j
This study is classified as acceptable and satisfies the data requirements for a prenatal
developmental toxicity study in rabbits (Guideline No. 83-3b).
e. Reproductive Toxicity
In a two-generation reproduction study, groups of Crl:CD BR rats (25/sex/group) were fed
diets containing Dicofol (93.3%) at dose levels of 0, 5, 25, 125 or 250 ppm (equivalent to 0.4, 1.9,
9.5, or 18.9 mg/kg/day for males and 0.4, 2.1, 10.5, or 20.5 mg/kg/day for females, respectively)!
One litter was produced in the first generation, and two litters were produced in the second
generation (MRID No. 41606601). "'.-.. " .
For parental systemic toxicity, the NOAEL was 5 ppm (0.4 mg/kg/day) and the LOAEL was
25 pprn (1.9/2.1 mg/kg/day for M/F) and above based upon histopathological changes in P and Fl
livers (hypertrophy of centrilobular hepatocytes with associated vacuolation) and Fl ovaries
(increased vacuolation). In addition, at 250 ppm (18.9/20.5 mg/kg/day in M/F), hypertrophy
/vacuolation of the adrenal glands was observed in P and Fl females (MRID No. 41606601).
For reproductive toxicity, the NOAEL was 5 ppm (0.4 mg/kg/day) and the LOAEL was 25
ppm (1.9/2.1 mg/kg/day in M/F), based on the ovarian vacuolation in the Fl females, which was
judged to be an effect on reproductive physiology. '. , , ' . .
For offspring toxicity, the NOAEL could be defined at 25 ppm (1.9/2.1 mg/kg/day for M/F)
and the LOAEL at 125 ppm (9.5/10.5 mg/kg/day for M/F), based on decreased F2 pup viability
(increased numbers of stillborn pups, postnatal day 0-4 pup deaths, and total litter loss). Additionally,
'. at 250 ppm (18.9/20.5 mg/kg/day in M/F), viability of Fl pups and Fl and F2a pup weight (Days 7
and 14) were decreased. ,
In a special one-generation postnatal toxicity study in Sprague-Dawley rats (30/sex/group),
96.4% Dicofol was administered at dietary concentrations of 5, 25, or 125 ppm (0, 0.3, 1.7, and 8.7,,
mg/kg/day for males, and 0,0.4,2,6, and 9.8 mg/kg/day for females, respectively, during premating)/
Parental animals were treated for 10 weeks, then mated. Selected Fl rats were weaned -and
maintained on treated diets until 70-100 days of age. A satellite group (10 treated FO females/dose),
which were mated with FO males from the main study to produce Fl offspring, were used for
evaluation of test material and metabolite residues in serum during the premating phase of the study,
in milk on days 2 and 12 postpartum, in prenursing neonate tissue, and in serum from weanling pups.
The animals were adequately exposed to the test material during all phases of the study as shown by
.-'".-. ' 15 ' .. .''''
-------
quantifiable levels of the Dicofol and metabolites in adult serum, milk, prenursing neonate tissue, and
weanling serum (MRID No. 44253801).
For parental systemic toxicity, the NOAEL was 25 ppm (1.7/2.0 mg/kg/day in M/F), and the
LOAEL was 125 ppm (8.7/9.8 mg/kg/day in M/F), based on increased absolute and relative liver
weights and on histopathologic findings in the liver of adult FO and Fl male and female rats
(centrilob.ular hypertrophy of hepatocytes with increased cytoplasmic eosinophilia).
For offspring toxicity, the NOAEL was also 25 ppm (1.7/2.0 mg/kg/day in M/F) and the
LOAEL was 125 ppm (8.7/9.8 mg/kg/day in M/F), based on histopathologic findings in the liver of
Fl weanlings (vacuolization of centrilobular hepatocytes in both sexes and hypertrophy of
centrilobular hepatocytes with or without increased cytoplasmic eosinophilia in females).
No treatments-elated effects were observed on the number of stillbprns, mean litter sizes at
birth, sex ratio, viability, clinical signs, or body weight of offspring. No treatment-related effects were
observed on parameters of reproductive function or performance: length of estrous cycle; epididymal
sperm count, concentration, motility, and morphology; testicular spermatid count and concentration;
sexual maturation as evidenced by age of vaginal opening in females and preputial separation in males;
mean precoital interval; mating and fertility indices; and median gestation length. For reproductive
toxicity, the NOAEL was >125 ppm.
In the two-generation reproduction study, vacuolati on of the ovary was observed in F1 females.
In the one-generation study, further examination of female reproductive function included evaluation
of estrous cyclicity. Vaginal smears were examined to determine the number of estrous cycles
attained within a 21-day period. Study results indicated that the mean number of estrous cycles in
the FO rats ranged from 5.2 in the control group to 5.4 in the high-dose group. In Fl females, the
mean number of estrous cycles ranged from 4.6 for controls to 5.3 for the high-dose group. In
addition, presentation of the cyclicity data in the study report indicated that there was only one FO
low-dose female that remained in diestrus for >6 days and no females of either generation remained
in estrus for >6 days. Based upon these findings, the study author concluded that there was no effect
on estrous cyclicity. However, it was noted by the reviewer that the criterion of >6 days of estrus
is an high-end value for abnormality of this single phase of the estrous cycle. A more appropriate and
Sensitive analysis of the data should address the number of females with >4 days of diestrus or >3
days of estrus, which are considered definitions of abnormality in the estrous cyclicity of the rat.
Individual data presented in the study report for either generation did not allow for a further analysis
of the cycle periodicity in this manner.
An expanded presentation of the cyclicity data, which includes the number of females with >4
days of diestrus or >3 days of estrus, is required. This information will be used to support or refute
the conclusion of tije study report, i.e., that dicofol does not affect the estrous cycle in female rats
under the conditions of this study. ,
Data in the sfudy report indicate inconsistencies in the evaluation of ovarian follicle count in
female rats following dicofol exposure. Variations in the follicle counts obtained in two separate
readings of the ovarian sections were not resolved in the study report.
16
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The technique used in the analysis of primordial follicle count was consistent with a 1995 draft
of proposed revisions to the EPA guideline for reproduction and fertility effects (OPPTS 870.3800).
The study protocol specified that one ovary would be serial sectioned and every tenth section would
be examined. However, this very likely resulted in the evaluation of ovarian sections from the outer
1/3 of each side of the ovary, where few if any primordial follicles would generally,be expected.
Depending upon the number of sections that originated in these areas of the ovary, the numerical
follicle count values for each rat could be substantially disparate and not representative of the actual
follicular population of the animal.' It is suspected that the source of the differences between the
duplicate follicle counts could be attributed at least in part to this technical aspect.
>
Ovarian histopathology samples should be reexamined to/more adequately evaluate the follicle
count data and to attempt to resolve inconsistencies in the study results. Depending on the methods
and procedures used in the registrants' histopathology laboratory, sections of each ovary may have
been preserved in such a manner so as to enable performing a revaluation, using only those sections
that originated in the inner 1/3 of the ovary. It is imperative that the number of sections evaluated
provide sufficient statistical power to adequately support the conclusions. It is further suggested
(based upon information presented at ari ILSI/HESI Workshop on Evaluation and Interpretation of
Reproductive Endpoints for Human Health Risk Assessment, November, 199?) that, in the reanalysis,
'growing and primordial follicles can be combined in the counting procedure, and that the number of
antral follicles need not be counted.
f. Mutagenicity
Dicofol at doses 'ranging from 5 to 5000 ug/plate did not cause mutations in an Ames assay
(MRID No.4Q042048). In addition, dicofol did not induce mutations in the in vitro Chinese hamster
ovary cell HGPRT assay which tested concentrations of 3.0 to 6.0 ug/ml withoutmetabolic activation
and 4.5 to 20 ug/ml with metabolic activation. (MRID No.40042049).
This study is classified as acceptable and satisfies the data requirements for a gene mutation
study (Guideline No. 84-2a). " '
There were no indications that dicofol at concentrations ranging from 7.5 to 20 ug/ml (without
metabolic activation) and 7.5 to 22.5 ug/ml (with metabolic activation) induced structural
chromosomal aberrations in an in vitro cytogenetic assay using Chinese hamster ovary cells (MRID
No.40042051). . '
This study is classified as acceptable and satisfies the data requirements for a ^structural
chromosomal aberration assay (Guideline No. 84-2b).
In an in vivo cytogenetic assay, groups of CRL:COBS-CD(SD) rats (30 males/dose) received
dicofol at doses of 47.8,191.2, or 478..0 mg/kg. Dicofol did not induce a clastogenic response in the
chromosomes of bone marrow cells of the test animals ((MRID No. 40042050).
This study is classified as acceptable and satisfies the data requirements for a structural
chromosomal aberration assay (Guideline No. 84-2b).
17
-------
Since the initial battery of mutagenicity studies (discussed above) demonstrate no mutagenic
activity, additional mutagenicity testing on dicofol is not required.
gl Neurotoxicity
,|i , | ,
In an acute neurotoxiqty screening study, groups of Crl :CDRBR VAF/PlusR rats (10/sex/group)
received a single oral administration of dicofol 95.5%) at doses of 0,15, 75, or-350 mg/kg At 350
mg/kg/day, dicofol produced an increase in the incidence of ataxia and of uncoordinated landing in
females. The 350 rag/kg/day females also showed signs of being asleep. Dicofol did not cause any
histopathological changes in the central or peripheral nervous systems. The NOAEL was 15
mg/kg/day and theLOAEL was 75 mg/kg/day, based on decreases in body weights and reduced food
consumptions (MRID No. 42633303).
This study is classified as acceptable and satisfies the data requirements for an acute
neurotoxicity study in rats (Guideline No. 81-8).
In a subchronic neurotoxicity study, groups of Crl :CDRBR VAF/PlusR rats (10/sex/group) were
fed diets containing dicofol (95.1%) at concentrations of 0, 5, 100, or 500 ppm, (0, 0.3, 5.6, or 27.8
mg/kg for males and 0, 0.3, 6.5, or 31.3 mg/kg for females, respectively). Dicofol did not cause any
histopathological changes in the central or peripheral nervous systems. The NOAEL was 5 ppm (0.3
mg/kg/day) and the LOAEL was 100 ppm (5.6 mg/kg/day), based on the decreased motor activity
and the increased liyer weight (MRID No. 42971401).
This, study is classified as acceptable and satisfies the data requirements for a subchronic
neurotoxicity study in rats (Guideline No. 82-7).
,";'\: ' ' ' hL Metabolism ' ' . ' ' . . . '
Metabolism studies in male and female Sprague Dawley rats used a single oral dose of 50
mg/kg of I4C-dicofol. The radiolabel was eliminated mainly in the feces and to a lesser extent in the
urine. The parent compound was preferentially stored in adipose tissue'. Also, when 14C-dicofol was
administered to female rats every day for 16 days at a dose of 0.5 mg/kg/day, the compound was
eliminated mainly in feces and stored in adipose tissue (MRID No. 43070104). The metabolic
pathways for dicofol were deduced, with the major one involving reductive halogenation to
dichlorodicofol (DCD) and oxidation to dichlorobenzophenone (DCBP), dichlorobenzoic acid
(DCBA), and dichlorobenzil (DCBH). This metabolic pathway is consistent with that proposed by
Brown and Casida (1987). Analysis of metabolites revealed that, at most, 0.2% of the radioactive
residue was DDE which could be contributed by the presence of DDT (0.2%) and DDE (0.01%) in
the test material. The data indicated that dicofol metabolized differently from that of DDT, which
is metabolized to the purported carcinogen, DDE (guideline 85-1; MRID No.00400420). This
conclusion is also supported by the data of Brown and Casida (1987).
In two comparative disposition studies in rats which received orally equal doses of (0.5 mg/kg)
dicofol and DDT, dicofol is consistently eliminated more rapidly than DDT in the test animals. Tissue
concentrations of radiolabel in fat, gonads, liver, adrenals, and muscle are not significantly different
between dicofol- and DDT-treated rats which were given (by gavage) multiple doses of dicofol or
18
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DDT (MRID No. 43070104). However, in another study rats received a single oral high dose (50
mg/kg) of either DDT or dicofol: More DDT was found in fat and adrenals than dicofol (MRID No.
43070103). In the blood, the radioactivity level is consistently higher in dicofol-treated rats than that
in DDT-treated ones (MRID No. 43070104).
A metabolism study comparing o,p'-dicofol and p,p'-dicofol was conducted in female rats. Test
animals received a single dose (50 mg/kg) by gavage. More radioactivity was eliminated by the o,p'-
14C-dicofol treated rats than that by the p,p'-14C-dicofol treated rats. In general, the t1/2 for the tissue
elimination of radiolabel was greater in p,p'-14C
-------
to U.S. House of Representatives Subcommittee on Health and the Environment (Guillette, 1993).
In 1980, the TowerCompany, which was adjacent to Lake Apopka, had a chemical spill. One of the
major products in the spill was KelthaneR (dicofol), which contained DDT at concentrations as high
as 15%, and pbf5s metabolites, ODD, DDE, and chloro-DDT. Guillette testified that, in his
investigations, alligator eggs and neonates from Lake Apopka differ from other Lakes in many
significant ways. The following observations are most significant:
1. Embryos and neonates within the first 10 days of life from Lake Apopka had high
mortality rates.
2. The ratio of estradiol to testosterone was substantially higher in neonates from Lake
Apopka than those from other lakes in Florida (estradiol level was higher than the normal
level, while testosterone level was lower than the normal concentration),
3. The increase in estradiol level corresponded to differences in the histological appearance
of the gonads. "Females from Lake Apopka exhibit ovaries containing large numbers of
polyovular follicles and polynuclear oocytes. Testes from males, show .poorly organized
seminiferous tubules." (Guillette's testimony).
4. Alligator eggs from Lake Apopka were found to contain significant levels of DDE.
When alligator eggs were experimentally injected with DDE, an abnormal testicular
Steroidpgenesis was seen. Males produced elevated concentrations of estradiol and
abnormally low levels of testosterone.
1, ' '' '" k"\ i ' '" , ' , . , ',',"".' ' * i ''"i ''"',',' . , ' ,''''.'!'' ' ."'',,".'
A published article (Heinz, Percival, and Jennings, 1991) showed elevated levels of several
organochlorines in alligator eggs from Lake Apopka collected in 1985. In those eggs, DDE was the
most commonly found organochlorine, but dicofol itself was not detected.
In the registrant's April 20, 1998 rebuttal, Rohm and Haas suggested that a source other than
dicofol may be the cause of the reproductive effects seen in alligators, and that possible co-
contamination with dibromochloropropane and/or ethylenedibromide may be responsible. However,
no data were submitted to substantiate the registrant's claim that these other chemicals could be
responsible.
2. Dose Response Assessment
a. Determination of Susceptibility to Infants and Children
Under the Food Quality Protection Act (FQP A), Public Law 104-170, which was promulgated
in 1996 as an amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
the Federal Food, Drug and Cosmetic Act (FFDCA), the Agency was directed to "ensure that there
is a reasonable certainty that no harm will result to infants" and children" from aggregate exposure to
a pesticide chemical residue. The law further directs that, in the case of threshold effects, for
purposes of establishing this reasonable certainty of no harm, "an additional tenfold margin of safety
foe the pesticide chemical residue and other sources of exposure shall be applied for infants and
children to take into account potential pre- and post-natal toxicity and completeness of data with
Vi - ' ' ' . "i ''!' ' ">i - ' :,' ""20 ' ' ' " " '''
-------
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
residue only if, on the basis of reliable data, such margin will be safe for infants and children " (FQPA
1996) / --, ' . , '
. ^ . = -
Determination of Susceptibility
The Hazard Identification Assessment Review Committee (HIARC)) determined that data
. provided no indication of increased susceptibility of.rats or rabbits fetuses following in utero
exposures in the prenatal developmental toxicity studies, or following postnatal exposure in the two-
generation reproduction toxicity study (Memorandum: J. Rowland toB. Madden dated December
17, 1997). '
Adequacy of Database
There are no data gaps for the standard Guideline 870 requirements for a food-use chemical
by40CFRPart 158. However, the HIARC determined that a postnatal developmental neurotoxicity
study; in rats is required for dicofol. This decision was based on the following factors:
1. evidence of neurobehavioral effects in the acute and subchronic neurotoxicity studies;
2: endocrine toxicity (adrenal and thyroid) was seen throughout the database;
3. , ovarian toxicity,-consistent with enhanced steroidogenic activity, was seen in the two-
generation reproduction study in rats;
4. structural activity concern (i.e., dicofol is structurally related to DDT, a neurotoxicant,
and DDE, an .endocrine disrupter) (Memorandum: J. Rowland to B. Madden, dated.
December 17, 1997); and
5. Uncertainty of the involvement of dieofpl in the reproductive failure of alligator
population following accidental spill into the Lake Apopka, Florida. :
Determination of the FOP A Safety Factor
The decision to apply an additional safety factor to ensure the protection of infants and children
from exposure to dicofol, as required by FQPA, was elevated to the OPP Division Directors, who
discussed the dicofol FQPA Safety Factor on April 9, 1998. It was determined that the additional
10X Safety Factor for the protection of infants and, children should be reduced to 3X (Tarplee arid
Rowland, 1997). , " - .; . , . -
-, , ~'' ' < * > >
Rationale for Selection of the FOP A Safety Factor
Although no increased susceptibility was seen in the prenatal developmental and post natal
developmental toxicity studies, it was determined that an FQPA Safety Factor is necessary for the
protection of infants and children. It was determined that the 10X Safety Factor can be reduced to
3X based on the following factors:
Data show no indication of increased susceptibility of rats or rabbits to ''in utero and/or
postnatal exposure to dicofol in the developmental and reproductive toxicity studies.
. ' - ' 21
-------
There are no data gaps for the Guideline 870 requirements. However, the Agency (HED
HIAJR.C Committee, December 17, 1997) has determined that a developmental neurotoxicity
study in rats is required, since dicofol produced neurotoxic effects in adult rats in the submitted
acute and subchronic neurotoxicity.
" ,, " 'in , i' i ', , ' ' *' '" . '" i, '', . ' '",,ป:'' ,11 ', i , ' *' ,' ! , , ' ,,i i! ;,,,;,
, , ' f f",,!,!'! ; ', >'! ,; : 'i ; ",: ' ' ',,'',, i ,'., , "' 4 "' ," ,i' ' ' i ',,| !,'!!' ' '"'I1 " V >
Although dicofol was shown to inhibit ACTH-stimulated cortisol release in dogs, no evidence
of endocrine toxicity was noted in the offspring in the one-generation reproductive study in rats
with a postnasal exposure phase.
Identification of Population Subgroups
%;;./:/ i' i iv !>;;:...:,." ',;' -y-" ',' ':>,..: . ,:;. .-' : '' > ;;'^ ;<'.;'' '/ "V,'"' , '^V
Acute Dietary:
The FQPA Safety Factor will be applied to all population subgroups because:
/i'1 ' , , ' :i , ' 'ifjis! i '""""- ,: :.'",'"' '' . '.. ,;"'".' ' . ', ; ".'',,': ;.'; V ' ' ^:"". '. ' /,.;'' ":i /'. ;. ''i! .j' i ,';,,;
1, the dose and endpoint is based on neurotoxicity for this risk assessment;
2. there is a data gap for the developmental neurotoxicity study; and
3. an endpoint appropriate for acute dietary risk assessment may be identified from the
developmental neurotoxicity study.
Chronic Dietary Risk Assessment:
The Agency's FQPA Safety Factor of 3X will be applied to all population subgroups because:
1. the dose and endpoint for this risk assessment is based on inhibition of adrenal cortical
trophic hormone (ACTH) stimulated release of cortisol in male and female of dogs; and
2. there is a data gap for the developmental neurotoxicity study..
'.jf1;' i| ' ' '' '' : l'1"!.:?'!. '' , ' ' '" i "" '' ,"' '!;, 11,..:'i , " ':,ป,' ',, ,."., *[./* , ', 'f '.'' } '. f'1' '' v ' ",
Residential Risk Assessments: Residential uses are being voluntarily canceled by the regi strants.
b. Chronic Reference Dose (RfD) ,
The Agency (HED RfD/Peer Review Committee (RFD PRC; January 27,1994)) recommended
an RfD of 0.0012 mg/kg/day based on the NOAEL of 0.12 mg/kg/day established in a chronic feeding
study in dogs and an Uncertainty Factor of 100 to account for inter-species variation (10X) and intra-
species extrapolation (10X). The NOAEL was based on the inhibition of adrenal cortical trophic
hqrjmone (ACTH)-stimulated cortical release in both sexes of dogs at 0.82 mg/kg/day (LOAEL).
On May 23,1997, the RfD/Peer Review reviewed the additional information submitted by the
registrants, which included results from the 1-year and the 90-day toxicity studies in dogs, along with
the special reproduction study. It was concluded that:
,: i ,: , ' ","- , " ,,,,''!' ' : , , : , "
1. the inhibition of cortisol release in females at 52 weeks was just as great as that which
occurred in the 12-week examination period.
2. The 90 minute cortisol level in females control rats at 25 weeks appeared to be low when
',!:. -...' $y: , .'. .; ;' : 22 .' ''''' "-. ' " ' ,' ";,'!,
-------
compared to the cortisol levels in female control rats at pretest, weeks 12 and 52..
3. There was a plight inhibition of the ACTH stimulated cortisol release at 10 ppm (=03
mg/kg/day) in both males and females of the 90-day feeding study in dogs, although the
, inhibition was not statistically significant. In addition, using the data from a chronic
feeding study in dogs is also more relevant in terms of the duration of exposure., .
, Additional confirmatory data considered by the Agency (RfD PRC) include organ weight
. findings from a postnatal study with dicofol (MRDD 44253801, 44253802, & 44253803). The
, members of the Committee believed that the significant perturbations in organ weights seen in the
confirmatory studies are indicative of endocrine disruption, even at the lowest level tested (5 ppm
equivalent to 0.3 mg/kg/day), where no other histological or lexicological findings were reported.
Therefore, the evidence of endocrine disruption at 0.3 mg/kg/day in this postnatal study in rats is
supportive of the position of the Committee that the NOAEL, which.is most appropriate to use in
establishing the RfD, and which is based on the inhibition in ACTH stimulated cortisol release, is at
5 ppm (0.12 mg/kg/day) from the chronic dog study, rather than at 10 ppm (0.3 mg/kg/day) from the
subchronic toxicity study in dogs. Using a weight of the evidence approach, the Committee decided
that revising the NOAEL from 30 ppm to 5 ppm in the 1-year feeding study in dogs was appropriate,
and applying the NOAEL of 5 ppm (0.12 mg/kg/day) for establishing a RfD was reasonable
(Memorandum, RFD Peer Review Report, January 27, 1994).
In December, 1997, the Agency (Hazard Identification Assessment Review Committee
(fflARC)) reassessed the RfD pursuant to FQPA. The HIARC concurred with the dose
(NOAEL=0.1,2 mg/kg/day), endpoint (inhibition of ACTH stimulated release of cortisol) and study
(chronic dog), but recommended an Uncertainty Factor of 300 (10X for inter-species variation, 10X
for intra-speeies extrapolation, and 3X for FQPA (Memorandum: J. Rowland to B Madden dated
December 17, 1997). . '
The FQPA Safety Factor of 3X, recommended by the Agency's FflARC, was concurred by the
FQPA Safety Factor Committee and this factor is applied for chronic dietary risk assessment.
c. Carcinogenic. Classification
The Agency (HED Carcinogenicity Peer Review Committee (CPRC)) has classified dicofol as
a nonquantifiable "Group C," possible human carcinogen. This classification was based on the
increase in the incidence of liver adenomas and combined liver adenomas and carcinomas in male mice
(MRID 41037801). The Agency recommended that, for the purpose of risk assessment, the RfD
.approach be used for quantification of chronic human risk. The RfD approach was used to assess
dietary cancer risk, and a quantitative dietary cancer risk assessment was not performed. Dietary risk
concerns, due to long-term consumption of dicofol residues, are adequately addressed by the ORES
chronic exposure analysis using the RfD.
d. Dermal Absorption
The dermal absorption study was determined to be not appropriate for use in dermal risk
assessments. Therefore, a dermal absorption factor of 100% (default value) will be used in
occupational risk assessments. For details see Section ni.B. 1 .i.
. ' 23 ' ' ' ' '
-------
";ป
e. Summary of Toxicological Endpoints for Use in Human Risk
'i'1' ' ' ' ' ^ Assessment
If,, ' , ?!,,i! i "- , .:':.: ,; ," ,:' .;,'', .' ' - ' '.- ;"," ,, " : .. > :.' ,..'. ',-;. vi'tif'. .'*!'
The Hazard Identification Assessment Committee (FJDLARC) selected the doses and
toxicological endpoints for use in dietary and non-dietary,(dermal and inhalation) in risk assessments.
i. Dietary: Acute Reference Dose
"i1" ' , '..I ' :. :'''' i,1 ', 1 ,; ', ' .:>. i ป < .',, , '-. .. ." , : ':, ป;"'
" , ;:';. ' " ,;,:,'! v :. ;i -'.i' -' ' " ! ' , ,i , ,, it", . ' ' '. ' ..;;.. ,'; ; ,' . Y;
\' : " "'.;' ' . i, "".'i'1 . ]' / ' . ""- i! i - : ii ,. i ;,: '" : ', iR ., .. ,' , '. : ' "' , ,' -," V1 ' '. ; ; Vf)1 .,':*'.
To estimate acute (one day) dietary risk, the endpoint chosen was neurotoxicity observed
following a single oral dose in an acute neurotoxicity study in rats (MRJD No. 42633303). The
NOAEL was 15 mg/kg/day and the LOAEL was 75 mg/kg/day, based on decreased body weight and
reduced food consumption. The NOAEL is divided by an Uncertainty Factor of 300 (10X for inter-
species variation, 10X for intra-species extrapolation, and 3X for FQPA), resulting in an acute RfD
of 0.05 mg/kg/day. The FQPA Safety Factor of 3X is applied to the acute dietary risk assessment
for all population subgroups.
ii. Dietary: Chronic Reference Dose
To estimate chronic dietary risk, the endpoint chosen was hormonal toxicity observed in a
chronic toxicity study in dogs (MRID 40997101). The NOAEL was 0.12 mg/kg/day and the
LOAEL was 0.82 mg/kg/day, based on inhibition of adrenal cortical trophic hormone (ACTH)
stimulated release of cprtispl in both sexes of dogs. The NOAEL is divided by an Uncertainty Factor
of 300 (10X for inter-species variation, 10X for intra-species extrapolation, and 3X for FQPA),
resulting in the chronic RfD of 0.0004 mg/kg/day. The FQPA Safety Factor of 3X is applied to the
Chronic dietary risk assessment for all population subgroups.
. ป iii. Dietary: Carcinogenic
i,' :, " : ' ' Si ""'. : , ' ,* ' :'' >: ' , i . : / ' ','..,, :t~ป: ";; . . '' 'i", ; ' , , ''t ' ,"','':!; s ;! '
To estimate the carcinogenic, risk, the Agency (CPRC) recommended the RfD approach for
quantification of chronic human risk. Therefore, a quantitative dietary cancer risk assessment was
not performed. Dietary risk concerns due to long-term consumption of dicofol residues are
adequately addressed by the DRES chronic exposure analysis using the chronic RfD.
iv. Dermal Absorption .
In the absence of an acceptable dermal absorption study, the use of a 100% (default value) is
required since oral NOAELs were selected for occupational dermal risk assessments. For details see
Section in.B.l.i.
'" .i1,! ป' ! . : i '.i,,. ' ' I, " , ' ' , ' i ,''.' f. ".,ซ' , .' ' ,,'' I , ,'' ',' 'ป,!,
v. Dermal: Shprt-Term Occupational Exposure (1-7 Days)
To estimate short term dermal risk, an oral dose (NOAEL) from a prenatal developmental
toxicity study in rabbits was used (MRID No!40042047). The NOAEL was 4.0 mg/kg/day and the
endpoint of concern was an increased frequency of abortions, at 40 mg/kg/day (LOAEL). Since an
oral MOAEL was chosen, a dermal absorption rate of 100% should be used for route-to-route
24
-------
extrapolations for risk assessments, A Margin of Exposure (MOE) of 100 is adequate for
occupational exposure. There are no residential uses at the present time. . -
Although 28-day dermal toxicity studies were available in rats and rabbits with formulation
products (44% active ingredient), the Agency's Hazard Identification Committee selected an oral
dose because:
1. the effects, (abortions) seen after a treatment of short duration '(11 days), which is
appropriate for this exposure period (1-7 days);
2. the NOAEL (4 mg/kg/day) was identical via the oral and the dermal routes in the same
species (rabbits), indicating credible dermal absorption via the route;
3. ' developmental effects are not evaluated in dermal studies; and . "
4. the oral NOAEL will provide adequate protection for pregnant workers.
"Therefore, the Committee 'considered the 28-day dermal toxicity studies to be co-critical.
In the 28-day dermal toxicity study in rats, the NOAEL was 4 mg/kg/day and the LOAEL was
40 mg/kg/day, based on slight decreases in body weights arid body weight gains, as well as an
increase in the incidence of liver hypertrophy, which was also seen at this dose. Although this was
considered as an adaptive effect, liver effects were also seen in rabbits via the oral route (MRID No
44099201). . '' . , , - : . .;
In the 28-dav dermal toxicity study in rabbits, the NOAEL was 4.1 mg a.i/kg/day and the
LOAEL was 10.2 mg a.i/kg/day, based on decreased body weight gain (MRID No. 41077001).
vi. Dermal: Intermediate-Term Occupational Exposure (1-Week to
- ' . , Several Months)
To estimate intermediate-term dermal risk, an oral dose (NOAEL) was selected from a 90-day
oral toxicity study in dogs (MRID 40042047). The NO AEL was 0.29 mg/kg/day and the endpoint
of concern was inhibition of ACTH stimulated cortisol release and oligospermatogenesis observed
. at 3.3. mg/kg/day (LOAEL). The Agency did not use the 28-day dermal studies because:
1. The endpoint of concern (i.e., hormonal toxicity) was seen both in the subchronic and
chronic feeding studies in the sensitive species (dogs) at comparable doses (0.29
mg/kg/day in the subchronic study and 0.12 mg/kg/day in. the chronic study); and
2, this developmental endpoint is not measured in the dermal toxicity studies. The use of
a dermal absorption factor is required since an oral NOAEL was selected for this dermal
risk assessment In the absence of an acceptable dermal absorption study, the default rate
of 100% was used. "
A Margin of Exposure (MOE) of 100 is adequate for occupational exposure. There are no
residential uses at the present time. -
25
-------
vii. Dermal: Long-Term Occupational Exposure (Several Months to
: ;ฃ .', ; ' .;- , /'-i ', '.' . Lifetime)' " " ' i ^ " ^ \ _ ' '_'"'" ' " " \ i
. jiijhir ; " ; , :' "-^v , , , .-i" , ,', a , , - ; _ < ,i ., ;j ; ;l;; > ,: , . . i ; - ; . i ^ . i;"c, j ; -t
Based on use patterns of dicofol included in this RED, the agency has determined that long-
term (chrpnic) exposure, or continuous exposure over several months, is unlikely. Therefore, dermal
risk assessments were not conducted.
yiii. inhalation: Any Time Period
Except for an acute inhalation toxicity study, for which Dicofol is placed in Toxicity Category
IV (LCM = >4.2 mg/L), no other toxicity studies are available via this route. Therefore, in order to
estimate inhalation exposure, the KARC selected the oral NOAELs of 4 rng/kg/day, 0.29 mg/kg/day,
and 0.12 mg/kg/day for the Short-, Intermediate-, and Long-Term, inhalation risk assessments,
respectively. Since oral doses were selected, route-to-route extrapolations should be as follows:
Step I. Convert the inhalation exposure value (ug/lb a.i/L) using a 100% absorption rate
(default value), application rate, and acres treated to an equivalent oral dose
Step II. Convert the dermal exposure component (mg/kg/day) using a 100% dermal
absorption rate (default), application rate and acres treated to an equivalent oral
: dose. '' --- '
Step III. Combine the oral equivalent doses in Steps I and II to obtain a total dose (dermal
ปi:-.- .. -..- ' . -tjnhalati,on). _ .
Step IV Compare the total oral equivalent dose to calculate the MOEs for:
short-term MOE = frOAEL of 4 mg/kg/day
intermediate term MOE= NQAEL of 0.29 mg/kg/day
The lexicological endpoints selected for various exposure scenarios are summarized in Table
3. ' " '
26
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3. Dietary Exposure and Risk Assessment/Characterization
Tolerances for residues in/on food/feed crops are currently expressed in terms of dicofol per
^[Source: 40 CFR ง180.163]. There are no tolerances established for animal commodities. The
^ncy, (HED Metabolism Committee; September 29, 1992) determined that dicofol is the only
rel^ue ฐf concern jn/on plants and that dicofol and its metabolites 1,1-bis (4-chlorophenyl)-2,2-
dichloroethanol and l-(2-chlorophenyl)-l-(4-chJorophenyl)-2,2,-dichloroethanol (FW-152) are the
residues of concern in animals. The chemical structures of dicofol and metabolite FW-152 are
depicted below in Figure A.
I. Figure A: The chemical structures of dicofol and the metabolites of concern
Structure .
Metabolite: Chemical name
Structure
Metabolite: Chemical name
CCL
ci cci
p,p -dicofol: l,l-bis(4-chlorophenyl)-2,2,2-
trichloroethanol
o,p -dicofol: l-(2-chlorophenyl)-l-(4-
chlorophenyl)-2,2,2-trichloroethanol
ci
ci _c\
p,p -FW-152: l,l-bis(4-chlorophenyl)-2,2-
dichloroethanol
o,p -FW-152: l-(2-chlorophenyl)-l-(4-
chlorophenyl)-2,2-di chloroethanol
a. Registered Food Uses
For a list of use sites and application rates, refer to Appendix A.
28
-------
b. Summary of Science Findings
Summary Of Residue Chemistry Guidelines . .
' i : " - ..'., " . . p
Residue chemistry data are adequate for the purposes of this RED. Additional residue
confirmatory data are listed in Chapter 5.
OPPTS 860.1200: Directions for Use ,.
A comprehensive summary of the registered food/feed use patterns of dicbfbl, based on these
product labels,-is presented in Appendix A and reflects revisions proposed by the registrants and
reviewed by the Agency. A summary of the residue chemistry science'assessments for reregistration
of dicofol is presented in Table 4. Conclusions listed in Table 45 regarding the reregistration
eligibility of dicofol food/feed uses are based on the use patterns registered by the basic producers,
Rohm and Haas and Makhteshim-Agan. When end-use product DCIs are developed (e.g.; at issuance
of the RED), the Agency should require that all end-use product labels (e.g., MAI labels, SLNs, and
products subject to the generic data exemption) be amended so they are consistent with the basic
producer labels.
Limited field trial data have been submitted on caneberries (blackberry, raspberry). Data are
adequate to support use on caneberries on an interim basis, but additional confirmatory field trial data
are required. .-..-.
The Wettable Powder/Dust (WP/D) formulation labels must be amended such that the
application rate and PHI for strawberries are consistent with the field trial parameters (Appendix A).
The crop field trials used to support the dicofol tolerance on strawberries was conducted using only
wettable powder formulations. Therefore, the Agency presently does not have the data to support
the use of emulsifiable concentrate formulations of dicofol on this commodity.
OPPTS GLN 860.1300: PJant Metabolism
The qualitative nature of residue in plants is adequately understood. Metabolism in plants
proceeds via hydrolysis and oxidation of the trichloroethanol moiety to form dichlorobenzophenone.
However, the parent compound remains the predominant residue. The Agency (HED Metabolism
. Committee; September 29,1992) determined that dicofol is the only residue of concern in/on plants.
Metabolism studies have been conducted with grapefruit, cottonseed, and tomato. Dicofol is not
translocated and is not metabolized to an appreciable extent. A study on citrus seedlings indicated
that <1% of leaf-applied [14C]dicofol was translocated from the leaf and <0.05% of soil-applied
chemical was taken up by the plant.
In a grapefruit metabolism study, fruit harvested up to 150 days after foliar, application of
uniformly ring-labeled [14C]p,p -dicofol at 4 Ib ai/A contained >98% of the radioactivity in the peel,
<1 ;4% in juice, and <0.6%,in pulp.. Dicofol accounted for >70% of the radioactivity in peel collected
29
-------
60 days after treatment and 50-60% in 150-day samples. The metabolite p,p -dichlorobenzophenone
(DCBP) accounted for <2%.
In the cottonseed metabolism study, dicofol comprised -60% of the radioactivity in whole seeds
harvested 15 days following two foliar applications of [14C]p,p -dicofol totaling, -5 Ib ai/A. DCBP
accounted for 15% of the residues in whole cottonseed,
A tomato metabolism study showed dicofol at 86.5% of the radioactive residues in tomato
fruits harvested 21 days after two foliar applications of [14C]p,p -dicofol at 2.4 Ib ai/A. DCBP
accounted for -1% of the residue and evidence of dichlorobenzhydrol (DCBH) at ~ 1% was detected.
In a parallel study with [14C]o,p -dicofol, DCBH and DCBP comprised 6.6 and 4.1% of the residue,
respectively.
OPPTS GLN 860.1300: Animal Metabolism
The qualitative nature of residue in livestock is adequately understood, based on acceptable
studies with goats and hens. The Agency (HED Metabolism Committee; September 29, 1992)
determined that dicofol and FW-152 are the residues of concern in animals. Goats were dosed with
[l4C]dicofol at 15 ppm in the daily diet for 7 days and sacrificed 24 hours later. FW-152 was the
major residue, comprising 27-67% of radioactivity in milk and tissues. Dicofol accounted for 10%
in kidney and 24-46% in milk, fat, and muscle. Dicofol comprised <1% of the liver residues, whereas
DCBP released by base hydrolysis constituted 15%. DCBP also comprised up to 17% of the residues
in milk and 18% in fat.
In the poultry metabolism study, hens were dosed with [14C]dicofol for 7 days at 10 ppm in the
daily diet. Dicofol accounted for 13-27% of the residue in whole eggs and 63-77% in fat and muscle.
FW-152 constituted up to 17% of the residue in eggs and fat, 22% in muscle, and 33% in liver.
DCBP comprised up to 50% of the residues in eggs, but < 10% in tissues.
OPPTS GLN 860.1340: Residue Analytical Methods-Plants and Animals
Three colbrimetric methods for dicofol determination in/on plants are listed in Pesticide
Assessment Methods (PAM), Vol. II (Methods A, B, and C). PAM, Vol. n also includes a reference
to a gas/liquid chromatography (GLC) method in PAM, Vol. I, for the determination of chlorinated
hydrocarbons. PAM, Vol. I (Section 211.13H) includes an high performance liquid chromatography
(HPLC) method for the determination of dicofol residues in milk. The GC/EC Method TR-310-86-
74 for plant matrices must be validated for cottonseed, tomatoes, and stone fruit by an independent
laboratory for inclusion in PAM. An acceptable independent laboratory validation (ILV) for
cottonseed, tomatoes, oranges, and stonefruit has been submitted. After successful validation, the
method will be validated by the Agency and will be submitted for inclusion in PAM for enforcement
purposes. The current PAM method is colorimetric. This requirement is considered confirmatory,
because multi residue methods have been shown adequate for recovery of dicofol from plant matrices.
30
-------
An HPLC/GC method for the determination of dicofol and FW-15 2 in animal commoditi es has
been validated by an independent laboratory for use as an enforcement method. The method will be
subjected to Agency validation and, then submitted for publication in PAM as an enforcement method.
PAM contains a HPLC method for the determination of dicofol in milk.
p,p -dicofol and o,p -dicofol are completely recovered (>80%) using FDA Multi residue
Protocol D (Section 302). p,p -dicofol is partially recovered (50-80%) using Multi residue Protocol
E for oily matrices (Section 304), whereas the recovery of the o,p -isomer using this method is small
(<50%). Recovery of both isomers using Protocol E for non-oily matrices (Section 303) is variable
(Source: PESTD AT A, PAM, Vol. I Appendix I, 1994).
OPPTS GLN 860.1380: Storage Stability
. . ^
Dicofol is stable in apples, string b'eans, and green peppers, stored at -20 C for 24 months.
Dicofol is stable in strawberries stored at -20 C for up to 12 months, and is stable in melons stored
at -20 C for up to 18 months. Dicofol is stable in citrus fruit, cottonseed, apples, string beans, and
green peppers stored frozen for two years. Dicofol and FW-152 are stable in poultry and cattle
tissues, milk, and eggs stored for up to seven months at frozen temperatures. No additional storage
stability data are required.
OPPTS GLN 860.1480: Magnitude of the Residue in Meat. Milk. Poultry, and Eggs
No tolerances have been established for dicofol residues in livestock commodities. However,
animal metabolism studies indicate that tolerances are needed for residues of dicofol and FW-152 in
meat, milk, poultry, and eggs.
The maximum theoretical dietary burden for dairy,cattle is 22 ppm and for beef cattle 41 ppm.
The existing ruminant feeding studies (10, 30, or 100 ppm feeding level) have been recently re-
evaluated and found adequate for. determining tolerance levels in meat, liver, kidney, meat
byproducts, and milk. ' ,
The maximum theoretical dietary burden of dicofol for poultry is 0.02 ppm, based on residues
in cottonseed meal (20% diet X 0.1 ppm residue). The existing poultry feeding studies (0.5 ppm
feeding level) have been recently re-evaluated and found adequate for determining tolerance levels
in poultry meat, liver, fat, meat byproducts, and eggs. -
OPPTS GLN 860.1500: Magnitude of the Residue in Plants
,. All data requirements for magnitude of th'e residue in plants have been evaluated and deemed
adequate to reassess the tolerances for residues of dicofol in raw plant commodities, with the
exception of figs. Interregional Program 4 (IR4) intends to provide data to support the use on
eaneberries and has submitted one field trial each for blackberries and raspberries,. Additional
, confirmatory data are required. Use of dicofol on figs is not being supported by the registrants.
. ' 31 -. '
-------
Field trials are required for caneberries and cotton gin byproducts. There are limited data for
caneberries to support the existing label use. Additional trials are required, but are considered
confirmatory. The requirement for cotton gin byproduct data is a recent development (Pesticide
Reregistration Rejection Rate Analysis Residue Chemistry: Follow-Up Guidance for Updated
Livestock Feeds Tables (06/94, EPA 738-K-94-001; revised 09/95)), and fulfillment of the
requirement will be considered confirmatory.
OPPTS GLN 860.1520: Magnitude of the Residue in Processed Food/Feed
All data requirements for magnitude of the residue in processed food/feed have been evaluated
anfj deemed adequate to determine the extent to which residues of dicofol concentrate in food/feed
items upon processing of the raw agricultural commodity. Dicofol has been shown to concentrate in
apple pomace, citrus oil, mint oil, dried tea, citrus pulp, cottonseed oil, raisins, and plum prunes.
Tolerances will be needed for these processed commodities.
", 3!!",, ;,' \ ; ";"., '. }:;?';! '' , .' ' :': ';' .'.''\f . , ,. . ... .;,. ,? . ; ,. , ,: ;., , " . ., '> .
OPPTS 860.1850 and 860.1900 Confined/Field Rotational Crops
Based on the review of recently submitted data on confined rotational crops treated with
dicofol, the Agency recommends that plantback intervals not be required for crops rotated with
dicofol-treated crops, since there was no quantifiable residue level at any interval. The Agency
further recommends that tolerances not be required for inadvertent residues on crops rotated with
dicofol-treated crops.
For purposes of the reregistration of dicofol, the data requirements for OPPTS 860,1850 and
860.1900 are fulfilled.
c. Anticipated Residues
As part of the Reregistration Eligibility Decision process for dicofol, anticipated residues of 1,1 -
bis(4-chlorophenyl)-2,2,2-trichloroethanol and l-(2-chiorophenyl)-l-(4-chlorophenyl)-2,2,2-
trichloroethanol in/on raw agricultural commodities and of these compounds, plus the dicofol
metabolites FW-152, isomers l,l-bis(4-chlorophenyl)-2,2-dichloroethanol and l-(2-chlorophenyl)-l-
(4;chlorophenyl)-2,2-dichloroethanol, in animal commodities must be determined in order to perform
dietary risk analyses. Table 4 lists anticipated residues of dicofol in all ORES food items resulting
from raw agricultural commodities with label uses for dicofol. Commodities with canceled
registrations are riot included. Table 4 also lists the anticipated residues of dicofol plus the metabolite
FW-152 in meat, milk, poultry, and eggs, resulting from the use of dicofol on animal feed items. US
FDA monitoring data (1991 - mid 1994), USDA POP survey data (1991-1994), field trial and
processing data, and/or reassessed tolerances were used in arriving at the values. Quantitative usage
information (percent crop treated based on acreage) was obtained from the sources indicated in
footnote #2 of Table 4.
32
-------
Anticipated residues for chronic (cancer and non-cancer) dietary exposure considerations are
based on survey data where an adequate sample size is available (> ca. 200 samples). Average .value
of all domestic and foreign FDA surveillance monitoring and all PDF monitoring samples is used for
chronic risk analysis anticipated residue value: In the absence of sufficient survey.data,- the average
of all relevant field trial residues, corrected for percent crop treated, is used as anticipated residue for.
chronic dietary risk analysis. In the absence of both survey and field trial data, such as for raw
agricultural commodities covered by translation of data from a very similar crop, the tolerance value,
corrected for percent crop treated, is used as the anticipated residue.
For determination of anticipated residues in livestock commodities for chronic dietary risk,
average residues from monitoring data were used as the basis for estimation of the dietary, exposure
of the livestock. Reasonable livestock diets were also used. For example, apple pomace and citrus
, pulp were not fed simultaneously. The practical dietary burden for dairy cattle was calculated to be
0.055 ppm, and for beef cattle, 0.11 ppm. These burdens were compared with the results.of the cattle
feeding study to estimate residues in milk, meat, fat, and meat by-products. s -
Dicofol (two isomers) alone is considered in the determination of anticipated residues in plant
commodities. However, dicofol and the FW-152 metabolite (two isomers) are considered by the
Agency in arriving at the anticipated residues for animal commodities.
Anticipated residues for dietary risk for acute and chronic exposure have been determined (S.
Funk,.CBRS 14225, DP Barcode D206745,09/12/95) and subsequently refined (S. Funk, 03/18/96;
S.-Funk, 04/3,0/96; S. Funk, DP Barcode D235741, fcBRS No. 17911, 06/03/97; S. Funk, DP
Barcode D236612, 07/01/97; S. Funk DP Barcode D246234, 6/11798). For purposes of
incorporating the various changes and refinements, the anticipated residues are summarized in Table
4, . . .--. . _ , . ; ' '
Dietary Risk Assessment Assumptions
Apple juice anticipated residue was based on the average processing factor (0.018), which is'
the average of five processing studies (6.015, 0.010, 0.030, 0.012, and 0.020) and the monitoring
data average for apples (0.014 ppm) multiplied by a processing factor of 0.018. Anticipated residue
is: . ' -.'','','
0.014 ppm X 0.018 = 0.00025 ppm.
Previously, DRES concentration factors were applied to the citrus raw agricultural commodity
values (survey data or field trial data or tolerance values) to arrive at anticipated residues in citrus
juices. The registrants maintain that this is inappropriate, because there are processing studies for
oranges to show that residues decline from the raw agricultural commodity to the juice. The Agency
agrees that studies do show a reduction in residue and that use of the default DRES factors are not,
therefore, appropriate. ; .
33
-------
Two processing studies were conducted in 1986 in California. Oranges with field-weathered
residues of dicofol, 3.79 and 4.46 ppm, were processed into juice, molasses, oil, and peel. In both
instances, total dicofol residue in the j uice was <6.01 ppm, corresponding to residue reduction factors
of 379X and 446X',respectively, with an average factor of 413X. Using this factor of 0.0024 based
on the processing studies (1/413), and the RAC field trial, tolerance, or survey values (S. Funk,
January 21, 1998, DP D240042), the following chronic anticipated residues are calculated:
grapefruit-juice: 6.012 ppm [PDP +FDA survey mean, n = 1626] X 0.0024 = 0.000029 ppm.
limes-juice: 6 ppm [group tolerance] X 0.0024 = 0.014 ppm
lemon- juice: 0.6 ppm [field trial average] X 0.0024 = 0.0014 ppm
oranges-juice: 0.012 ppm [PDP + FDA survey mean, n = 2825] X 0.0024 = 0.000029 ppm
tangerines-juice: 0.012 ppm [orange] X 0.0024 = 0.000029 ppm.
''Acute anticipated residues would also be reduced through use of the orange processing factor
to 0.03 ppm for grapefruit juice (highest field trial X 0.005), 0.007 ppm for lemon juice (highest field
trial X 0.005), 0.03 ppm for lime and tangerine juices (6 ppm group tolerance X 0.005), and 0.02
ppm for orange juice (highest field trial X 0.005).
iiSi"! '""
Rohm and Haas Company maintains that more reasonable residue values can be obtained for
processed &apefractions through the use of survey data and processing factors, rather than field trial
data and processing data. There were 2,237 PDP grape samples and 3,121 FDA grape samples
analyzed in 1991 - 1994, with an average residue of 0.016 ppm. Applying the average processing
factors of 4.7X for raisins and 0.25X for juice, the chronic anticipated residues are 0.075 ppm in
raisins and 0.004 ppm in juice. The registrants use a factor of 0.027X for juice, but the data indicate
factors of OJX and 0.4X, average 0".25X (Table 1-42; S. Funk, DP D206745, 08/95)!
the previous ORES calculation concentrated dicofol residues in both the fat and non-fat
fractions of milk. This is not possible. The whole milk residue value of 0.0015 ppm (S. Funk,
D236612, 07/01/98) would-represent a conservative estimate for non-fat fractions. The 0.04 ppm
value of Table 4 (S. Funk, 01/21/98, DP D240042) applies as stated to milk fat (only). The estimated
concentration factor from whole milk to milk fat is 30X. .
The anticipated residues indicated in Table 4 represent new estimates for citrus juices, apple
juice, grape juice, raisins, and non-fat milk fractions. These new anticipated residues were used in
DRES calculations, ' "' '.I " '.,' '',"' " '/ ' " ' """' ' ;' :
:34
-------
Table 4: Anticipated Residues of Dicofol in Plant Commodities and of Dicofol Plus FW-152 in Animal
Commodities for Dietary Risk Assessment
Food Item
Apples
Apples-dried4
Apples-juice
Apricots
Apricots-dried
Beans-dry-Great
Northern
Beans-dry-Kidney
Beans-dry-Lima
Beans-dry-Navy
Beans-dry- other
Beans-dry-Pinto
Beans, dry-hyacinth
(mature seed)
Peas, black-eyed
Beans-dry-garbanzo
(chick pea)
Beans, lima,
succulent
Beans, snap-
succulent-green
Beans- succulent-
other
Beans-succulent-
yellow wax
Beans-succulent-
broadbeans
(immature seed)
Food Code
0400 1AA
0400 ID A :
0400 1JA
05001AA
0500 ID A
15001AA
1500 1AB
15001AC
15001AD
15001AE
15001AF
.15030AA
1503 1AA
15032AA
15002AA
15003AA
15003AB
15003AC
15022AB
Residue Data Somes
Chtfxuie
Survey
Survey4
Survey/
Processing
Tolerance
Tolerance5
Field Trial
Field Trial
Field Trial
Field Trial
Field Trial
Field Trial
Field Trial
Field Trial
Field Trial
Survey
Survey
Survey
Survey
Survey
Acute
Field Trial
Field Trial4
Field Trial/
Processing
Tolerance
Tolerance5
Tolerance
Tolerance
Tolerance
^Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
%Cr0p
'Iteated^
4
4
4
1
1
,2 . .
2
2 ,
2
2
2 -
2
2
2
2
2
2
2
2
Chronic
Aattetpate
-------
Food Item
Beans-succulent-
hyacinth (young
pods)
Blackberries
Boysenberries
Butternuts
Cantaloupes-pulp
Casabas
Cattle, MBYP (exc.
kidney & liver)
Cattle, fat
Beef- kidney
Beef-liver
Cattle, meat
Cherries
Cherries-dried
Cherries-juice
Chestnuts
Chickcn-MBYP
Chicken-flesh
(+skin, w/o bones)
Clu'cken-flesh (w/o
skin, \v/o bones)
Chicken-giblets
(liver)
Crenshaws
Grapefruit-pulp
Food Code
15030AB
01002AA
01003AA
03010AA
10002AB
10003AA
53001BA
5300 1FA
53001KA
5300 1LA
53001MA
05002AA
05002DA
05002JA
03004AA
55015BA
55015MB
55015MA
55015LA
10004AA
02002AA
Residue Data Source
Chronic
Survey
Survey
Tolerance
Tolerance
Survey
Survey
Feeding
Study
Feeding
Study
Feeding
Study
Feeding
Study
Feeding
Study
Survey
Survey6
Survey7
Tolerance
Feeding
Study
Feeding
Study
Feeding
Study
Feeding
Study
Survey
Survey
Acute ,
Tolerance
Tolerance
Tolerance
Tolerance
Field Trial
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Field Trial
Field Trial6
Field Trial7
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Field Trial
%Crop
treated^
2
1
1
2
30
30
N/A
N/A
N/A
N/A
N/A
1
1
1
2
N/A
N/A
N/A
N/A
30
16
Chronic
Anticipated
Residue
-------
Food Item
Grapefruit-juice
Kumquats
Lemons-pulp
Lemons-juice
Limes
Limes-juice
Oranges-pulp
Oranges-juice
Tangerines
Tangerines-juice
Citrus, oil
Cotton, seed, meal
Cotton, seed, Oil
Crabapples
Cucumbers"
Dewberries
Eggplant
Eggs
Filberts (Hazelnuts)
Food Code
02002JA
02003 AA
02004AB
02004 JA
02005Ab
02004 JA
02006 AB
02006JA
02008 AA
02008JA
/
90999AB
27003 WA
270030A
. 04002 AA
10010AA
01004AA
11001AA
55014AA
03005AA '
Residue Data Souree
Chronic
Survey/
Processing
Tolerance .
Field Trial
Field Trial/
Processing
Tolerance
Tolerance/
Processing
Survey
Survey
/Processing
Survey
(orange)
Survey
(orange)
/Processing
(orange)
Field Trial
/Processing
(orange)
-Field Trial/
Processing
Filed Trial/
Processing
Tolerance
Survey
Tolerance
Survey
_ Feeding
Study
Tolerance
Acute
Field Trial/
Processing
Tolerance
Field Trial
Field Trial/
Processing
Tolerance
Tolerance/
Processing
Field Trial
Field Trial/
Processing
Field Trial
Tolerance
/Processing
(orange)
Tolerance/
Processing
Field Trial/
Processing
Field Trial/
Processing
Tolerance
Field Trial
Tolerance
Tolerance,'
Tolerance
Tolerance
s%Grop
^Treated2'3
16
16
16
16
16
16
16
16
16
16
16
10
10
4
1
100
100
N/A
2
Chronic
Anticipated
Residue
{ppn),
0.000029
10
0.6,
0.0014
6
0.014 .
0.012
0.000029
0.012
0.000029 "
200
0.03
0.3
10
0.003
5
0.01
0.002
0.1
Acute
Anticipated
Reside
(ppm) t '
0.03
10
1.5
0.007
6
0.03
4
0.02
5
0.03
200
0.03
0.3
10
0.5
5
2
0.05
0.1
37
-------
Food Item
Peppers, Bell
Peppers, Chili
Peppers, Other
Pimentos
Tomatoes
Tomatoes-juice
Tomatoes-puree
Tomatoes-paste
Tomatoes-catsup
Goats, MBYP (exc.
kidney & liver)
Goats, fat
Goats, kidney
Goats, liver
Goats, meat
(boneless, lean)
Grapes-fresh
Grapes-raisins
Grapes-juice
Hickory Nuts
Food Code
11003AA
11003AB
11003AD
11004AA
11005AA
11005JA
11005RA
11005TA
11005UA
53002BA
53002FA
53002KA
53002LA
53002HA
01014AA
01014DA
01014JA
03006AA
s
Residue Data Souice
Chrdnie
Survey
Survey
Survey
Survey
Survey
Field Trial/
Processing
Field Trial/
Processing
Field Trial/
Processing
Field'Trial/
Processing
Feeding
Study
Feeding
Study
Feeding
Study
Feeding
Study
Feeding
Study
Survey
Survey/
Processing
Survey/
Processing
Tolerance
Acute "
Survey/
Tolerance
Survey/
Tolerance
Survey/
Tolerance
Survey/
Tolerance
Field Trial
Tolerance/
Processing
Tolerance/
Processing
Tolerance/
Processing
Tolerance/
Processing
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Field Trial
Tolerance
Tolerance/
Processing
Tolerance
%Crop
Treated^
>
5 -
5
5
5-
3
3
3
3
3
N/A
N/A
N/A
N/A
N/A
3
3
3
2
Chronic
Anticipated
Residue
-------
Food Item
MeatBy-Products
(MBYP) (exc.
kidney & liver)
Hogs, fat
Hogs, kidney
Hogs, liver
Hogs, meat
Honeydew Melons
Hops, dried
Horses, MBYP (exc.
kidney & liver)
Horses, fat
Horses, kidney
Horses, liver
Horses, meat
Loganberries
Milk, fat
Milk, non-fat
Mint, oil,
peppermint
Mint, oil, spearmint
Nectarines
Fowl Code
53006BA,.
53006FA
53006KA
53006LA
53006MA
10005AA
08020AA
53003AA
53003AA
53003 AA
53003 AA
53003AA
01005AA
50000FA
28080AA
2808 1AA
05003AA
Residue Data Source
^
Chronic-
Feeding
Study
Feeding
Study
Feeding
Study
Feeding
Study
Feeding
Study
Survey
Field Trial
Feeding ;
Study
Feeding
Study
Feeding
Study
Feeding
Study
Feeding
Study
Tolerance
Feeding
Study ,
Feeding
Study
Field Trial/
Processing
Field Trial/
Processing
Survey
Acute
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Field Trial
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Derived
Tolerance
Tolerance
Tolerance
%Croj>
Treated5*5
^
N/A
N/A
N/A
N/A
N/A
24
6
N/A '
N/A '
N/A
N/A .
N/A
100
N/A
N/A .
30
30
100
Chronic
^Anticipated -
Residue
-------
Food Item
Peaches
Peaches-dried
Pears
Pears-dried
Pecans
Persian Melons
Plums
Plums, Prunes-dried
Plums, Prune-juice
Poultry, other
byproducts
Poultry, other-
giblets (liver)
Poultry, other-flesh
(+skin, w/o bones)
Pumpkins
Quinces
Raspberries
Sheep, MBYP
Sheep, kidney
Sheep, liver
Sheep, fat
Sheep, meat
Squash,, summer
Squash, winter
Strawberries
Foo
-------
Food Item
Tea
Turkey-MBYP
Turkey-flesh (w/o
skin, w/o bones)
Turkey-giblets
(liver) ..
Walnuts
Watermelons '
Wine and Sherry
Food Code
07003AA
55008BA '.'
55008MA
55008LA
03009AA
10008AA
43058AA
Residue Data Source
Chronic
Tolerance/
Brewing
Study
Feeding
Study
Feeding
Study
Feeding
Study
Tolerance
Survey
Field trial/
Acute
Tolerance
Tolerance
Tolerance
Tolerance
Tolerance
Field Trial
Tolerance/
%Crop *
Treated2*3
10
N/A-
N/A
N/A
2
11
6
Chronic
Anticipated
Residue
-------
4s Dietary Risk from Food Sources
."1...J
Residues
Tolerances for dicofpl residues in/on food and feed crops are published in 40 CFR Section
180..163. There are no tolerances established for animal commodities. Tolerances for animal
commodities are now needed and have been included in the chronic analysis. Default concentration
factors were generally not used for this analysis, because specific anticipated residues were given for
rno'st food forms.
1111 ' I ' ' " , i . , ' ' ' '!,
Chronic Exposure:
A summary of the residue information considered in the chronic analysis was previously
presented in Table 4. Although some of the percent crop treated values recorded in this table differ
slightly from those presented in Table 1, in general they are overestimates and therefore represent a
more conservative exposure assessment.
A ORES chronic exposure analysis was performed using anticipated residues and percent of
crop treated, if applicable. Estimated chronic dietary risk for the U.S. general population and the
highest subgroups are given in the table below.
Table 5: Chronic Dietary Food Exposure and Risk Estimate to Dicofol (from food alone)
Population
U.S. Population
Non-Nursing Infants(< 1 year)
Children (1-6 years)
Children (7-12 years)
Exposure (mg/kg/day)
0.000076
0.000129
0.000150
0.000104
Percent of the
RfD
19
32
38
26
",", ' ' , ", ! i'"iii:;,, I' ij ',, , ,,i'. I1 "!!, ,' ' i ' , -, . ,i 'i i . ''Xi ! ,."v '" , ' T s,. . " , , " i,ป' n :". ' , IS,, " ; ,,, ; , ,',; , .,r
Estimated chronic dietary risk for the U.S. general population and all subgroups are below the
Agency's level of concern for food alone. However, this estimate does not include the contribution
of drinking water to dietary risk (which is discussed below in Section e, "Dietary Risk from Drinking
Water Sources"). Dietary exposures from almost all food commodities were based on refined
residues, such as anticipated residues or tolerance level residues corrected for percent of crop treated
information applied. These estimates are not worst-case and are not expected to represent gross
ovei-estimates of chronic dietary risk to dicofol. The FQPA Safety Factor of 3X has been applied
to the RfD for this analysis (RfD = 0.0004 mg/kg/day), because the RfD is based on inhibition of
adrenal cortisol trophic hormone (ACTH) stimulated-release. Generally, the Agency is not concerned
about dietary risk if the risk estimate results in less than 100% of the RfD.
42
-------
Acute Exposure: .'.- , ;
The percentage of the acute reference dose is a measure of how close theucute exposure comes
to the Reference Dose, and is calculated as the ratio of acute exposure (mg/kg/day) to the'acute RfD
(mg/kg/day). In this case, because the endpoint is based on neurotoxicity, the FQPA Safety Factor
of 3X has been incorporated into the acute RfD for use with the dietary risk assessment.for all
population subgroups. The resulting acute RfD is .0.05 mg/kg/day. Generally, acute dietary risk
estimates greater than 100% of the Acute RfD exceed the Agency's level of concern.
Rohm and Haas has provided a probabalistic acute dietary Monte Carlo (MC) analysis (MRID
44636501). TheMC includes percent-crop treated data, and a distribution of residues obtained from
field trial data. The analysis was reviewed and found to be acceptable. Acute dietary estimates at
the 99.9th percentile exposure, are summarized in Table 6. The acute'dietary risk estimates based
on this highly refined exposure assessment do not exceed the Agency's level of concern.
Table 6; Djcofol Acute Dietary Exposure Estimates at the 99.9th Percentile (from food alone)
Population . ,
US Population
Non-nursing infants (<1 year old)
Children (1-6 years old)
Children (7-12 years old)
Exposure (mg/kg/day)
0.017523
0.044923,
0.034919
0:024705
% of Acute RfD
35 . '
90 .1
70
49
e. Dietary Risk from Drinking Water Sources
There is no established Maximum Contaminant Level (MCL) for residues of dicofol in drinking
water. No. health advisory levels for dicofol in drinking water have been established.
''- . ' i - . ,
Ground Water :
A tier 1 assessment that provides estimates of the concentration of dicofol in ground water was
conducted. This tier 1 assessment used SCI-GROW, an empirical model based on actual ground-
water .monitoring data from small-scale prospective groundywater monitoring studies, to estimate
upper bound concentrations of a chemical in vulnerable ground water. The SCI-GROW model
estimated a 90-day peak average concentration of 0.069 ug/1 for dicofol in ground water. This value
was compared to drinking water levels of comparison (DWLOCs) calculated for both acute and
chronic effects pf dicofol. Because the concentration of pesticides in ground water is not expected
to fluctuate widely, a single value was selected for acute and chronic exposure assessments.
,43
-------
Surface Water
The Agency calculated ti er 2 (PRZM-EXAMS) estimated environmental concentrations (EECs)
foe dicofol in potential surface water sources. The EEC's are based on the environmental fate data
for p,p'-dicofol, since it occurs in the greatest proportion (4.5:1 ratio with o,p'-dicofol) and is the
more persistent of the two isomers. The EEC's were revised in June, 1998 to reflect the overall mean
EECs for surface water, The Agency has characterized the surface water estimates by stating that
further revision and refinement of the numbers would not result in lower values, and that even the
available monitoring data is in the same general range as the model estimates. Estimated overall mean
concentration of digpfol in surface water is 0,5 ug/1.
Drinking Water Risk
The Agency has calculated drinking water levels of comparison for acute and chronic exposures
to dicofol in drinking water for the adult general U.S. population and non-nursing infants (< 1 year
old), respectively.
Acute Dietary Risk from Drinking Water
For acute exposure to dicofol, the drinking water level of comparison (DWLOC) for the U.S.
population is 1,140 ug/1; for non-nursing infants (<1 yr. old): 50 ug/1; for children 1-6 years, old: 150
ug/1; and for children 7-12: 250 ug/1
For acute exposure to the U.S. population, excluding infants and children, the Agency uses a
body weight of 70 kg and 2 liters consumption of water per day for adults. For infants and children,
the Agency uses a body weight of 10 kg and 1 liter consumption of water per day.
As stated previously, the estimated overall mean concentration of dicofol in surface water (from
PR^M-EX^AMS) is6.5 ^g/L and 6.069 ^g/L for ground water (from SCI-GROW). The estimated
average concentration of dicofol in either surface or ground water is less than the Agency's drinking
water levels of comparison for dicofol for the adult U.S. general population, and all population
subgroups. Therefore, the Agency does not have an acute dietary risk concern from exposure to
dicofol to the US population.
Chronic Dietary Risk from Drinking Water
For chronic exposure to dicofol, the drinking water level of comparison (DWLOC) for the US.
populatidn is 11.34 ug/1; for non-nursing infants (<1 yr. old): 2.5 ug/1; for children 1-6 years old;2.71
ug^; and for children 7-12: 2.96 ug/1.
For chronic exposure to the U.S. population excluding infants and children, the Agency uses
a body weight of 70 kg and 2 liter consumption of water per day for adults and a body weight of 10
kg and 1 liter consumption of water for infants and children.
-------
-The estimated average concentration of dicofol in either surface of ground water (0.5 Mg/L and
0.069 Mg/L, respectively) is less than the Agency's drinking water levels of comparison for dicofol
-the adult U.S. general population, and all population subgroups. .Therefore, the Agency does not
have a chronic dietary risk concern from exposure to dicofol to the US population. "
4. Occupational and Residential Exposure and Risk Characterization
An occupational and/or residential exposure assessment is required for an active ingredient if:
1. certain toxicological criteria are triggered and
2. there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or
to persons entering treated sites after application is complete.
However, because the registrants have removed these residential uses from the technical label
these uses will be canceled on these products. All other products containing dicofol are intended
solely for non-residential uses.
a. Use Pattern and Formulation Summary
Applications of dicofol can be made using either ground-based or aerial equipment. Ground-
based application methods include high volume sprays, low volume sprays, and spot treatments,
among others. Aerial application methods include low volume sprays only. Soil incorporation is not
required for any of these uses. The timing of applications is generally not restricted to specific time
periods during the growing season of each crop/target with the exception of any previously
established pre-harvest intervals. Based on the types of crops/targets to which dicofol can be applied,
the use of several types of application equipment is possible. Application rates for the emulsifiable
concentrate and flowable concentrate formulations can range up to 4 Ib ai/acre (air and ground-based)
while the application rate for the wettable powder formulations can range up to 3 Ib ai/acre. Ground-
based application volumes range from 20 to 1;600 gallons per acre while aerial application volumes
range from 3 to 10 gallons per acre. -"'.'' '
The registrants have proposed the following reduced maximum application rates (Rohm and
Haas rebuttals dated 6/18/96 and 4/20/98): 6 Ib ai/acre for citrus (since reduced to 3 Ib ai/acre); 3 Ib
ai/acre for apples and pears; 2 Ib ai/acre for pecans and walnuts; 1.5 Ib ai/acre for cotton; 2.4 Ib
ai/acre for strawberries (since reduced to 2.0 Ib ai/acre); 1.3 Ib ai/acre for grapes; 1.5 Ib' ai/acre for
stonefruits; 0.63 Ib ai/acre for cucurbits; 1.5 Ib ai/acre for beans; 0.75 Ib ai/acre for tomatoes'and
peppers; and 0.55 Ib ai/acre for nonresidential lawns and ornamentals.
Based on the use patterns and potential exposures described above, 14 major exposure
scenarios were identified for dicofol:
1. mixing/loading wettable powder for aerial application;
2. mixing/loading wettable powder for ground-based application;
. " ' ' -. ' ' 45 . ' ' ..'.'. ''' -
-------
3. mixing/loading liquid for aerial application;
4, mixing/loading liquid for ground-based application;
5. mixing/loading liquids for high pressure handwand application;
6. applying the liquid formulation with groundboom;
7. applying the liquid formulation with aerial equipment;
8. applying the liquid formulation with airblast sprayer;
9. applying the liquid formulation with high pressure handwand sprayer;
10. applying sprays with a handgun (lawn) sprayer ;
11. flagging during the application of the liquid formulation with aerial equipment;
12, mixing, loading, and applying the liquid formulation with backpack sprayer;
13. mixing, loading, and applying the liquid formulation with hose-end sprayer; and
14. mixing, loading, arid applying the liquid formulation with low pressure handwand
sprayer. ' ,
The Agency has determined mat there is potential exposure to persons entering sites previously
treated with dicofol. Postapplication exposures may occur to agricultural workers following
applications to the crops identified in the use summary during routine hand-labor crop-production
tas|s, such as hoeing, thinning, and harvesting activities, as well as non-hand-labor tasks, such as
crop-advisor and irrigation-related activities.
b. Assumptions
;:'"'' ' .. ' ." :'=' .' ' ' ' ; ! " "'V " '. .' . ..." - , .' "."." .:-,' , "..' ..- '.:..'' . .' " .' v :'"""'
Total exposure was calculated by summing the oral dose equivalents of inhalation and dermal
exposure, men compared with the appropriate NOAEL for risk assessment. Application rates, daily
maximum area treated, and daily baseline exposure (for workers wearing baseline protection: long
pints', long sleeved shirt, shoes, arid socks) are provided in Table 8 below. CropTSpecific application
rates and acreage information were provided by Rohm and Haas in order to determine a more refined,
accurate exposure assessment (6/97). Unit exposure data were derived from the Pesticide Handlers
Exposure Database ()PHED), Version 1.1. Exposure scenario details, such as level of confidence,
PPE, engineering controls, and standard assumptions are presented in Tables 7-12.
The PHED was developed by Health Canada, The American Crop Protection Association, and
EPA. PHED was initially released for public use in 1992. PHED is a generic/surrogate exposure
database containing a large number of measured values of dermal and inhalation exposure for
pesticide workers (e.g., mixers, loaders, and applicators) involved in handling and applying pesticides.
The database currently contains data for over 2,000 monitored exposure events. Use of surrogate
or generic data is appropriate, since it is generally believed that the physical parameters of the
handling and application'process (e.g., the type of formulation used, the method of application, and
the type of clothing worn), not the chemical properties of the pesticide, control the amount of dermal
and inhalation exposure. Thus, PHED typically allows exposure and risk assessments to be
conducted with a much larger number of observations than are normally available from a single
exposure study.
46
ll",.," ii':ซJW iiiiiMiU'lM iiJilll;'^ bLt
-------
PHED also contains algorithms that allow the user to complete surrogate task-based exposure
assessments.beginning with one of the four main data files contained in the system (i.e., mixer/loader,
applicator, flagger, and mixer/loader/applicator). Users select data from each file and construct
exposure scenarios that are representative of the use of the chemical. The Agency, in conjunction
with the PHED task force, has evaluated all of the data currently in PHED, and developed a surrogate
exposure table that contains a series of standard exposure estimates for various scenarios. These
standard unit exposure values are the basis for this assessment. The standard exposure values (i.e.,
the unit exposure values included in the exposure and risk tables) are based on the "best fit" values
calculated by PHED, PHED calculates "best fit" exposure values by assessing the distributions of
exposures for each body part included in data sets selected for the assessments (e.g., chest or
forearm),' and then calculates a composite exposure value representing the entire body. PHED
categorizes distributions as normal, lognormal, or "other." Generally, most data contained in PHED
are lognormally distributed or fall into the PHED "other" distribution category. If the distribution is
lognormal, the geometric mean for the distribution is used in the calculation of the "best fit" exposure
value. If the data are an "other" distribution, the median value of the data set is. used in the
calculation of the' "best fit" exposure value. As a result, the surrogate unit exposure values that serve
as the basis for this assessment generally range from the geometric mean to the median of the selected
data set. '
The Agency's first step in performing a handler exposure assessment is to complete a baseline
exposure assessment. The baseline scenario generally represents a handler wearing long pants, a
long-sleeved shirt, and no chemical-resistant gloves. If the level of concern is met or exceeded, then
increasing levels of risk mitigation, such as PPE (personal protective equipment) and engineering
controls, are used to recalculate the MOE's, until the exposure is sufficiently reduced to achieve an
appropriate margin of exposure. ,
. Handler Exposure Data '
Data for the dicofol handler exposure assessment was obtained from the Pesticide Handlers
Exposure Database (PHED), Version 1.1. Confidence levels in the available data (ranging from low
to high) and other details are provided in Table 12.
I , ' ' - v
Handler (Mixer/Lbader/Applicator) Exposure Scenarios
The Agency has determined.that there is a potential exposure to mixers, loaders, applicators,
or other handlers during usual use-patterns associated with dicofol. In particular, the Agency is
concerned about exposures to handlers during the treatment of crops by ground and aerial equipment,
and during treatment of ornamentals using hand-held equipment.
Exposure Calculations - ,
The following calculations are used to assess the risk to handlers.
47
-------
,,. , ,. ., ,. . . , , ,,,, ,, -
Daily Exposure (mg ai/day) is calculated using the following equation:
Daily Systemic Dose due to Dermal Exposure (mg/kg/day) is calculated using the following
formula: ' '
, ...... , ,, ,,,
Daily Systemic 'Dose \ !?&} = Daily Exposure \ 2HL. 1 | - 1 - 1 Dermal Absorption
[Kg Day) ' * (Day) ( Body Weight (Kg) ) F
Short Term and Intermediate Term Risk/Margin of Exposure (MOE) was calculated using
the following formula:
' ' ' ' ' '
UOE = _ g day>
" Absorbed Daily Dose
' '
TJ1"'' 'iff; :"(;'',
Exposure and risk for the short term and intermediate term uses of dicofol are summarized in
the tables below. Short-term occupational risk was calculated using the endpoint of 4.0 mg/kg/day,
with an MOE of aijeast 100 required. Intermediate-term occupational risk was calculated using the
0.29 mg/kg/day HOAEL (EPA, Hazard Identification Assessment Review Committee Report,
December 17, 1997) with a required MOE of 100 or more. The Agency (HED Metabolism
Committee; September 29, 1992) determined that dicofol and FW-152 are the residues of concern
in animals. - . . ' ,
Exposure was calculated under the assumption of 100% dermal absorption and therefore may
result in an overestimation of risk.
Postapplication Exposure Data
Significant potential for exposure exists for workers after application of dicofol. Chemical-
specific post-application exposure or environmental fate data (as regulated by Series 875) have not
been submitted in support of the reregistration of dicofol. Therefore, a surrogate range-finding post-
. "application exposure assessment was performed for occupational settings. In this assessment,
dislbdgeable foliar residue (DFR) are assumed to be 20% of the application rate and dissipation is
assumed at 10% per day. Environmental fate data were not reviewed for the surrogate assessment.
The study indicates that prolonged restricted-entry intervals are necessary to protect workers.
Although exposure at residential sites is likely to be lower than for occupational use sites, a post-
application residential risk assessment was not conducted because restricted entry intervals are not
feasible in residential settings. The Agency has concerns regarding ppst-application exposure for
occupational use sites, and requests that the registrants submit the required data (see Section 4) as
soon as possible. A new DFR study is being conducted by the registrants and is due in October 1998.
Until these data are submitted and evaluated, the post-application use scenarios remain a concern.
:": ." ;!.;! ": , V . / .' , '. .'. -48 ',
-------
c. Occupational Handler (Mixer/Loader and Applicator) Exposure and
Risk Assessment/Characterization
The registrants have agreed to risk reduction 'measures, including revised use patterns,
application rates, water soluble packaging for all wettable powder formulation products, and
additional personal protective equipment. , ;
Another suggestion made by the registrants in the rebuttal (MKDD 44552801) was to add
gloves, coveralls, and respirators to labels for mixer/loaders using water soluble packets; In response,
the Agency has stated that it has reservations about requiring additional PPE, other than gloves, such
as double layers of clothing and respirators, in addition to engineering controls, (closed mixing
loading systems, such as water-soluble packet) and does not recommend that particular mitigation
measure.
Short-term estimated risks, based on the exposure values in Table 7 are presented in Table 8,
for workers with baseline clothing and with additional PPE. Intermediate-term estimated risks, based
on the exposure values in Table 7 are presented in Table 9 for workers wearing baseline clothing in
addition to PPE. Tables 10 and 11 present the estimated risk for workers when engineering controls
are implemented in addition to PPE.
The registrants have committed to move to water soluble packaging for all wettable powder
formulations in an effort to reduce exposure. Therefore, riskto mixer/loaders when handling wettable
powder formulations of dicofol was only calculated for workers using water soluble packaging, a
closed system (engineering controls), so the risk estimates for these workers appears only in Tables
10 and 11. Water soluble mixing will be in place for all wettable powder systems in 1999.
Occupational Handler Risk Estimates
With the agency's current assumption of 100% dermal absorption, estimated risks for short-
term and intermediate-term exposure for all handlers wearing baseline personal protective equipment
(long sleeved shirt, long pants, shoes, and socks), all show MOEs of less than 100 and, therefore,
exceed the Agency's level of concern. .
With additional PPE consisting of a double layer of clothing, chemical resistant gloves, and an
organic vapor-removing respirator, workers have reduced exposure but risks for some short-term and
intermediate-term use scenarios still result in MOE's below 100. ; '
Only the following short-term use scenarios result in acceptable MOE's above 100 and do not
exceed the Agency's level of concern for occupational risk with additional PPE consisting of a double
layer of clothing, chemical resistant gloves, and an organic vapor-removing respirator "(from Table
8): , - ' - -. '. " . ." " ' . ' .. ^
Mixing/loading Liquids for Groundboom Application to Peppers and Tomatoes
49 ,
-------
Groundboom Application to Beans, Strawberries, and Peppers and Tomatoes
High Pressure Handwand Application to Lawns/Ornamentals
Flagging for Application to Grapes, Cucurbits, and Tomatoes and Peppers
All other short-term exposure scenarios result in MOE's below 100 and exceed the
Agency's level of concern.
There are no intermediate-term use scenarios which result in acceptable MOE's above
100 (from Table 9). "_'_' " "" ',".". ''","' " "." ".' .".'.".',.".' '"' ". ',!'. , .'.. '
With engineering controls consisting of closed mixing/loading systems (water soluble packaging
for wettable powders and enclosed delivery systems for liquids) and closed cabs for all application
and flagging scenarios, workers have exposure reduced further, but the risks for some short-term and
intermediate-term use scenarios result in MOE's below 100.
Only the following short-term use scenarios for workers using engineering controls result in
MOE's above 100 and do not exceed the Agency's level of concern for occupational risk (from
table 10):
Mixing/Loading Wettable Powders for Groundboom Application to Peppers and Tomatoes.
Mixing/Loading Liquids for Aerial Application to Cucurbits and Peppers and Tomatoes.
* Mixing Loading Liquids for Groundboom Application to Strawberries, Mint, and Beans
All Groundboom Application Scenarios.
Aerial Application to Pecans/Walnuts, Grapes, Stonefmit, Cucurbits, and Peppers and
"""Tomatoes. , ,' .
All'Xirbiast Application Scenarios.
All Flagging Scenarios. .
All Other Scenarios With MOE' s Above 100 as Mentioned Above.
AH other use scenarios result in MOE's below 100 and exceed the Agency's level of
concern.
Only the following intermediate-term use scenarios for workers using engineering controls
result in acceptable MOE's above 100 and do not exceed the Agency's level of concern for
Occupational risk (from Table 11):
All Flagger Use Scenarios, except citrus.
All Other Scenarios With MOE's Above 100 as Mentioned Above.
All other intermediate-term use scenarios result in MOE's below 100 and exceed the
Agency's level of concern.
50
-------
The Agency assumes that by wearing an organic vapor removing cartridge respirator, workers
can reduce inhalation exposure by an estimated 90 percent. Likewise, the Agency assumes that fabric
coveralls worn over baseline'protection can reduce dermal exposure by 50 percent. The PHED
.exposure data used to calculate risk estimates for handlers wearing baseline clothing, with PPE, and
with engineering controls, varies from poor quality ("low confidence") to high quality ("high
confidence"). Generally, if at least 15,PHED data records are available and the data quality are
graded A and/or B, the source is considered with, high confidence. If fewer than 15 PHED data
records are available or the data quality is low, the source is considered with low confidence.
The registrants asserted in their April 20,1998 rebuttal that, "Dicofol users will not be handling
this product exclusively on an all-day basis for more than a few days at most in any given season."
The Agency agrees and acknowledges that the occupational handler risk assessment is conducted
using assumptions which attempt to account for the inherent variability in use practices and human
behavior. Some of the assumptions used in the handler risk assessment may be too conservative for
the typical applicator, but are reasonable for a commercial applicator. Other assumptions, such as
the. dermal absorption rate of 100% or the number of acres treated per day must be used in the
absence of real data in order to be protective of public health. : .
51
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?PE: Dermal A, B, C grades and inhalation acci
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Engineering Control: Dermal grades acceptabl
PHED data used for baseline and engineering cor
addition of coveralls, 90% PF for the addition of
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addition of coveralls, 90% PF for the addition of (
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d. Occupational Post Application Exposure and Risk Assessment/
Characterization
Post Application Summary
The Agency is concerned about postapplication exposure and risk to agricultural workers
following applications to the crops identified in the use summary (Appendix A) during routine hand-
labor crop-production tasks, such as hoeing, thinning, and harvesting activities and non-hand-labor
tasks, such as crop-advisor and irrigation-related activities.
A Data-Call-in (DCI) for chemical-specific post-application exposure data (as regulated by
Series 875.2100, 875.2400, and 875.2500) was issued October 13,1995, and is due in October 1998.
In lieu of these data, a surrogate range-finder post-application exposure assessment was performed
for occupational or residential settings.
The range finder assessment in Table 13 is based on the minimum and maximum application
rates of 0.63 Ib ai/A and 3 Ib ai/A, respectively. The transfer coefficients (TC) range from low
exposure potentials (500 cm2/hr), such as hoeing, to high exposure potentials (10,000 cm2/hr), such
as citrus harvesting. The restricted entry interval (REI) ranges from 44 days to 79 days.
Table 13: Dicofol Intermediate-Term Postapplication Agricultural Surrogate Assessment (Range Finder)
a
b
c
d
DAT
0
44
65
72
94
DFR
/ ; >}xF,
fa&<
Min.
Rate
1.41
0.014
0.001
0.001
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Max,"
Rate
8.97
0.087
0.010
0.005
0.002
Dermal Dose (rrtg/kg/dayf
Mtn. Rate
Low
0.094
0.001
N/A
N/A
N/A
High
1.88
0.018
0.002
0.001
N/A
, Max. Rats
Low
0.598
0.006
0.001
N/A
N/A
High.
11.96
0.116
0.013
0.006
0.003
MOB4
Mm Rate
Low
3
318
N/A
N/A
N/A
Big
h
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16
145
303
N/A
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Low
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50
460
N/A
N/A
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48
100
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DAT = Days after treatment.
DFR (#g/cm2) = Appl. rate (Ib ai/A) x 11.209 (^g per cm2/lb ai per acre conversion) x 0.2 (fraction of
ai retained on foliage). Dissipation is assumed at 10% per day (environmental fate data were not
reviewed for this surrogate assessment).
Dermal Dose (mg/kg/day) = DFR(^g/cm2) x Tc (cm2/hr) x 1 mg/1000 //g conversion) x 1 (100% dermal
absorption) x 8 (hrs/day) / 60 kg BW. Where LOW = 500 cm2/hr and High = 10,000 cm2/hr,
MOE = NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day). Where NOAEL = 0.29 mg/kg/day.
70
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Based on results of this analysis, several scenarios had MOEs below 100. Therefore, the
Agency has concerns regarding post-application exposure. The DFR data is currently being
- generated in response to the October 1995 Data Call-in: Until these .data are submitted, from the.
postapplication exposure study s and evaluated, post-application use scenarios remain a concern. A
final REI will be set based the DFR Data which will be submitted to the Agency in October, 1998.
However, in the interim, EPA will set an REI of 24 hours.
e. Residential and Other Non-Occupational Exposures and Risks
The registrants have voluntarily canceled all residential turf uses; therefore, the Agency did not
include estimated risks to homeowners from residential exposure in the exposure and risk tables
(Tables 7-12).
Additionally, the registrants have voluntarily canceled all residential ornamental uses of dicofol.
Therefore, the risk from this use was not calculated.
f. Incidence Reports
Cases of dicofol poisonings were reported to the following data bases as of October 10, 1995.
OPP Incident Data System: Nine incidents involving dicofol have been received since the
inception of the data base in 1992. Eight of these involved exposure to multiple pesticides; the
specific pesticide responsible for the reported illnesses (mostly dermal irritation) could not be
determined. The only incident in which dicofol was used alone involved fish and wildlife effects.
California Department of Food and Agriculture (CDFA): A total of 38 incidents involving
exposure to dicofol alone were reported from the years 1982-1992, inclusively. The following types
of illnesses were reported for these cases: systemic -19 (50%); skin -10 (26%); eye - 8 (21%); and
eye/skin - 1 (3%). One person was hospitalized as a result of dicofol related illness/Applicators and
field workers were the most frequently exposed workers.. The number of incidents per 1000
applications of dicofol for the years 1990-1992, inclusively, was calculated. (As of 1990, information
is available for all agricultural uses; prior to that, only data on restricted use applications were
required to be reported.) The number of incidents/1000 applications for all illnesses ranged from 0.11
to 0.21. The number of systemic illnesses/1000 applications ranged from 0.09 to 0.11. These values'
are about one-half the median of those reported for 28 organophosphate and carbamate pesticides
involved in a Data Call-In (DCI) for pesticides of risk to agricultural workers. Based on these recent
data, it appears that dicofol represents a relatively low risk to farm workers and handlers in California.
National Pesticide Telecommunications Network (NPTN): This database collected reports
from 1984 to 1991 (inclusive) showing 91 human, 9 animal, and 31 other poisoning incidents for a
total of 131 incidents involving dicofol from 571 phone calls made to the hotline.
71
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5. Food Quality Protection Act Considerations
_, a. Cumulative Effects
Section 408(b|(2)(D)(y) of the Food Quality Protection Act requires that, when considering
Whither.,to,, establish^ modify, or revoke a tolerance, the Agency considers "available information"
conCerninS th6 cumHlative 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 mostpesticides, 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
^Sty wim ?ฃy ฐther substances, the Agency does not at this time have the methodologies to
resolve the complex scientific issues concerning common mechanism of toxicity in a meaningful way.
the Agency has begun a pilot process to study this issue further through the examination of particular
classes of pesticides. The Agency hopes that results of this pilot process will increase the Agency's
scientific understanding; of this^question such that the Agency will be able to develop and apply
scientificprinciples for better determining which chemicals have a common mecha^
evaluating the (emulative 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. -
;h at present the Agency does not know how to apply the information in its files
concerning common mechanism issues to most risk assessments, there arepesticides as to which the
common mechanism issues can be resolved. These pesticides include pesticides that are
toxlcologicallydissimilar to existing chemical substances (in which case, the Agency can conclude
that it is unlikely that a pesticide shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case, a common mechanism of activity
will be assumed).
Dicofol is a member of the organochlorine class of pesticides. Other members of this class
include DDT, methoxychlor, chlorobenzilate and ethylan. Less clgsely related members of the class
include lindane, dieldrin, endrin, chlprdane, heptachlor, aldrin, endosulfan, kepone, and toxaphene
(George W. Ware, Fundamentals of Pesticides, Thomson Publications, 1982).
At this time, the Agency does not have available data to determine whether dicofol has a
common mechanism of toxicity with other substances or how to include this pesticide in a cumulative
risk assessment. For the purposes of this tolerance action. Therefore the Agency has not assumed
that dicofol has a common mechanism of toxicity with other substances.
-------
b. Endocrine Disrupter Effects
EPA is required to develop a screening program to determine whether certain substances
(including all pesticides and inerts) "may have an effect in humans that is similar to an effect
, produced by a naturally occurring estrogen, or such other endocrine effect..." The Agency is currently
working with interested stakeholders, including other government agencies, public interest groups,
industry and research scientists in developing a screening and testing program and a priority setting
scheme to implement this program. Congress has allowed until August 3, 1999 to implement this
program. At that time, EPA may require further testing of this active ingredient and end use products
for endocrine disrupter effects.
c. Special Sensitivity of Infants and Children
For an evaluation of special sensitivity of infants and children, see section ni-B-2-a.
d. Aggregate Risk
'
In examining aggregate exposure, FQPA directs EPA to take into account available information
concerning exposures from pesticide residues in food and other exposures for which there is reliable
information. These other exposures include drinking water arid non-occupational exposures (e.g.,
to pesticides used in and around the home). Risk assessments for aggregate exposure consider both
short-term and long-term (chronic) exposure scenarios, considering the toxic effects which would
likely be seen for each exposure duration. -
Acute Aggregate Risk '. '
Acute aggregate risk assessment for dicofol include risks associated with dietary exposure
through food and drinking water only. Estimates of exposures to dicofol from food sources through
' highly refined probalistie analysis do not exceed the Agency's levels of comparison.
DWLOCs, for residues of dicofol in drinking water therefore are^ relatively high (50 p'pb for'
non-nursing infants, the riiost sensitive subgroup) compared to conservative modeling estimates of
dicofol concentrations (Tier II/Prizm Exams). Therefore, the Agency concludes with reasonable
certainty that acute aggregate exposure to pesticidal dicofol does not exceed the Agency's level of
-'concern., .
Chronic Aggregate Risk :
The chronic aggregate risk assessment for dicofol includes risks associated with dietary
exposure through food, water, and any registered residential uses with the potential for chronic
exposure. Anticipated residues and percent crop-treated data for commodities with published
tolerances result in an exposure to dicofol through food which represents 19% of the RfD for the
U.S. general population. The highest subgroup, children (1-6 years), occupies 38% of the RfD.
Dietary risk for non-nursing infants occupies 32% of the RfD, and dietary riskfor children (1-7 years)
occupies 26% of the RfD. Tier 2 estimated average concentrations in ground water (0.069 ppb) or
73
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surface water (0.5 ppb) do not exceed drinking water levels of comparison (DWLOCs) for the
general U.S. population or any of trie population subgroups. The registered residential uses of dicofol
do not present a chronic residential exposure scenario. Trie Agency thus concludes that aggregate
Chronic exposure and risk estimates do not exceed the Agency's level of concern.
Short Term and Intermediate Term Aggregate Risk
1 i ป M i
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There are no residential exposures. Therefore, an aggregate risk assessment is not required.
C. Environmental Assessment
i
1. Exposure Characterization
,
The Agency has adequate data to assess the hazards of dicofol to nontarget terrestrial
organisms.
a. Environmental Fate Assessment
Laboratory and field studies show that dicofol isomers have a short to intermediate half-life
(days to months) and are moderately persistent in the environment as a result of normal label uses.
In ecological monitoring studies conducted in New York, Florida, and California, dicofol dissipated
from the soil surface with a half life ranging from two to four months. The major routes of
dissipation appear to be hydrolysis in neutral and alkaline pHs and microbially-mediated degradation.
o,p'-Dicofol dissipates more rapidly than p,p'-dicofol. o,p'-Dicofol hydrolyzes rapidly and is
somewhat susceptible to photolysis in water. Photolysis does not play a role in the degradation of
p,p'-dicofol. Mobility and volatilization do not significantly contribute to the dissipation of the dicofol
isomers.
',' v .
Dicofol and DDT are similar in chemical structure. However, important differences in
chemistry separate these two organochlorine pesticides. Dicofol has an environmentally significant
water solubility providing dicofol with a pathway for degradation; DDT does not. Dicofol has an
environmental half-life of weeks compared to years for DDT. While dicofol has some ability to
accumulate, DDT has a much greater ability to do so. Most importantly, dicofol does not degrade
to DDE, but to degradates less toxic than dicofol, whereas DDT degrades to DDE which has been
identified as the toxic moiety.
For dicofol, evidence for endocrine disruption is suggestive, but not definitive. It clearly has
reproductive effects in some species, although they appear to differ somewhat from its close
analogues, DDT and/or DDE. Whether the difference is due to the ability of dicofol to be
metabolized to less toxic chemicals, its relatively short half-life, or the reduced potency of the parent,
is not known at this time. It is clear, however, that dicofol does not present the enormous
bioaccumulation potential of DDT/DDE and for that reason alone may be deemed of lesser concern
than DDT/DDE. = " ' ' ' " ' ' """" "' '"' ." ' ,
74
-------
, i. Degradation and Metabolism
Dicofol is relatively insoluble in water (1.32 ppm @ 25ฐC) and partitions with organic solvents
(Kow=l.lxl06). It is not likely to volatilize extensively (vapor pressure=3.9xlO"7 mm Hg at 25ฐ C,
calculated Henry's Constant 1.44xlO"7 atm m2/mol). Dicofol contains <0.1% DDT and its residues
in its current formulation. . ; :
o,p'-dicofol and p,p'-dicofol hydrolyze relatively quickly at neutral and alkaline pHs. Both
isomers are stable under acidic conditions. o,p'-dicofol hydrolyzed with half-lives of 47 days at pH
5, 8 hours'at pH 7, and 9 minutes at pH 9 (MRJD 40042033). p,p'-dicofol hydrolyzed with half-lives
of 85 days at pH 5, 64 hours at pH 7, and 26 minutes at pH 9 (MRIDs 40042032 and 40460105).
The major degradate in both studies, the o,p'- and p,p'-isomers of dichlorobenzpphenone (DCBP),
appeared to resist further degradation. Chlorobenzoic acid (CBA) was also observed in the pH 7
solution in the o,p'- study; other minor degradates were isolated, but not identified in the p,p'- study.
In. acidic (pH 5) water, o,p'-dicofol photolyzes moderately rapidly, while p,p'-dicofol does not.
o,p'-dicofql photodegraded with a half-life of 15 days, in a pH 5 solution (MRID 40849702). The
major degradate was o,p'-DCBP. In contrast, o,p'-dicofol degraded with a half-life of 32-33 days in
the dark control. p,p'-dicofol photodegraded with a half-life of 92 days in a pH 5 solution (MRID
40849701). The major degradate was p,p'-DCBP. The half-life of the dark control was 149-246
, days.
Photolysis on soil is not an important route of degradation for dicofol, possibly due to binding
on the soil and lack of solubility in soil water. o,p'-dicofol degraded with a half-life of 30 days while
p,p-dicofol degraded with -a half-life of 21-30 days on silt loam soil irradiated with artificial light that
does not simulate natural sunlight (MRTDs 40042036 and 40042037). The major degradates
identified in the studies were the o,p' and p,p' isomers of DCBP. '
Aerobic soil metabolism plays an important part in the degradation of o,p'-dicofol; it is less
important for p,p'-dicofol. o,p'-Dicofol degraded with a half-life of 8 days in a loam soil (MRID
41094201). The maj or metabolites were 1 ,(2-chlorophenyl)-1 -(4'-chlorophenyl)-2,2-dichloroethanol
(o,p'-FW-152), o,p'-DCBP, 2-chlorobenzoic acid (2-CBA), 3-hydroxy-2,4-dichlorobenzophenone
(OH-o,p'-DCBP), and 2,4'-dichlorobenzhydrol (o,p'-DCBH). Unextracted residues comprised 57-
61% of the applied amount after 12 months, while volatile residues were <4%. p,p'-Dicofol degraded
with a half-life of 43 days in a silt loam soil (MRID 41050701). The major metabolites were l,l-(p-
chlorophenyl)-2,2-dichloroethanol (p,p'-FW-152), p,p'-DCBP, and 3-hydroxy-4,4'-
dichlorobenzophenone (3-OH-p,p'-DCBP). Volatile residues were 21-22% of the applied and
unextractable residues were 10-15% of the applied after 12 months.
The o,p'-isomer of dicofol apparently will not persist long in anaerobic soils. o,p'-Dicofol
degraded with a half-life of 6 days from a flooded silt loam soil under anaerobic conditions (MRID
43908701). The major degradates were o,p'-FW-152 (averaging 43% of the applied 30 days after
- flooding) and o,p'-DCBH (averaging 15% of the applied 30 days after flooding). Samples were aged
aerobically for 3 days before flooding. p,p'-Dicofpl declined during 60 days of anaerobic incubation,
' . - , .'" '75. '''.-
-------
with a half-life of <30 days (MRID 40042039). Major degradates were p,p'-FW 152 and 4,4'-
dichlorobenzhydroi fo
ii. Mobility
ii, Both isomers of dicofol show moderate to low mobility in batch equilibrium and column
leaching studies, with little potential to leach to ground water. o,p'-dicofol showed low mobility in
sand, sandy loam, and clay loam soil column leaching experiments (MRID 41509802). Of the applied
radioactivity, 75 to 98% remained in the upper 1 or 2 inches of the columns. Less than 3% of the
applied radioactivity was in the leachate. The degradate o,p'-DCBP was present at 1-11% of the
recoVered radioactivity in the soil columns. In batch equilibrium studies, mobility of p,p'-dicofol was
moderate in sand (Freundlich K^ and Koc values were 8.4 and 8383, respectively) and low in sandy
loam (Kad8 of 64.6; KM of 8073), silt loam (Kads of 70; Koc of 5868), and clay loam (Kads of 82.8; Koc
of 5917) soil slurries (MRID 41509801). The Kdes values ranged from 29.3 to 335.
Two supplemental leaching studies conducted on p,p'-dicofol suggest that the chemical does
not significantly leach under the testing conditions (IDs GS0021002 and GS0021007). No data are
available on the mobility of aged dicofol or on the mobility of the major degradates of dicofol. Based
on the resujts of thejerrestrial field dissipation studies, it appears that dicofol metabolites are not very
mobile under nprmgl us,e condition^.
iii. Bioaccumulation
p,p'-dicofol residues accumulated in bluegill sunfish with bioconcentration factors of 6,600,
17,000, and lO.OOOX in fillet, viscera, and whole fish, respectively, during 28 days of exposure (Ace.
NOj265330). The estimated elimination half-life was 33 days. No information is available on the
biqaccumulation in fish for p.p'-dicpfbl. Little information is available on bipaccumulation in other
fish species. However, since o.p'-dicofol hydrolyzes quickly (t^=8 hrs at pH 7), it may not be
available under normal aquatic conditions to bioaccumulate in fish.
A supplemental confined rotational crop study suggests that dicpfpl may accumulate in plants
and therefore be available to mammals (MRID 43958701). Persistence data indicate that dicofol,
especially the p,p'-isomer, has the potential to accumulate in the soil for a short period of time.
However, estimated bioconcentration factors suggest that dicofol is not expected to bioconcentrate
significantly^.
Supplemental monitoring studies (see vi below) show that dicofol residues may be found in low
concentratipflS; in different matrices, including soil, crop foliage, earthworms, aquatic habitats, and
selected bird species. However, dicofol residue levels were lower than those of background DDE
levels, often by 1 to 2 orders of magnitude.
1 Howard, P.H, (Ed.). 1991. Handbook of Fate and Exposure Data for Organic Chemicals.
VoL HI - Pesticides. Lewis Publ.
-------
* iv. Field Dissipation
Although supplemental, several terrestrial field dissipation studies confirm the results of the
laboratory persistence and mobility studies. These studies suggest that dicofol does not persist in the
field for long periods (on an order of several days to several weeks): In a dissipation study on cotton
in California (MRID 41381801), half of dicofol residues dissipated in less than 7 days (DT50 value,
which is the length of time required for 50% of the parent to dissipate from the surface 6-inches of
the soil). In another dissipation study on strawberries in California (MEUD 42118601), the.rate of
dissipation was slower (DT50s of 22 days for o,p'-dicofol and 72 days for p,p'-dicofol). Differences
in dissipation rates were related to greater amounts of irrigation in the cotton study. Results of these
studies suggest that metabolism is the dominant route of dissipation in the field. Neither dicofol nor
its residues moved significantly below 6 inches in either study. .The major degradates observed in
these field studies - o,p' and p,p'-DCBP, o,p'-DCBH, 4-CBA, and p,p'-FW 152 - are not the same
as those associated with DDT.
v. Spray Drift
No dicofol-specific studies were reviewed. Droplet size spectrum (201-1) and drift field
evaluation (202-1) studies were required, since the different products may be applied by aircraft and
due to the concern for potential risk to nontarget aquatic organisms. To satisfy these requirements,
the registrants, in conjunction with other registrants, formed the Spray Drift Task Force (SDTF). The
SDTF has completed and submitted to the Agency it's series of studies which are intended to
characterize spray droplet drift potential due to various factors, including application methods,
application equipment, meteorological conditions, crop geometry, and droplet characteristics. EPA
has evaluated those studies associated with aerial spray applications, and will evaluate those studies
associated with ground spray applications in the near future. This assessment of dicofol used -
simplified off-target drift rates of 1% of the applied spray volume from ground applications and 5%
from aerial and orchard air blast applications at 100 feet downwind. After its review of the new
studies, the Agency will determine whether a reassessment of the potential risks from the application
of dicofol to nontarget organisms is warranted.
vi. Monitoring Studies
Comprehensive ecological monitoring studies of dicofol residues were conducted for three years
in California cotton fields (1990-92; MRIDs 41785102, 41857301, and 42285503), Florida citrus
groves (1989-91; (MRIDs 41785103, 41845605, 42091501, and 42437301), and New York apples
orchards (1989-91; (MRIDs 41845604, 42285501, and 42721301). Areas and crops selected had
a previous history of heavy dicofol use and a high likelihood for exposure to nontarget organisms.
Application rates typified those most commonly used by the growers and not necessarily the
maximum label rates. Dicofol residues were monitored in soil, adjacent waters, plant foliage, fish,
mammals, reptiles, amphibians, earthworms, birds, and bird eggs. In these studies, the overall half-
lives for the residues of p,p'-dicofol in soils vary from 58 days in California to 113 days in Florida.
In New York, it was not possible to calculate a half-life in the 90-day observation period. In all
studies, o,p-dicofol was present at much smaller concentrations than p,p'-dicofol.
5 - ; - " . 77 - '
-------
ill .1 i' i i i in II ,1
Residues of p,p'-dicofol were detected in the foliage of crops and dissipated with a half-life
ranging from 9 days (cotton) to 61 days (citrus crops). Dicofol was found at a cbncentration of 1-2.
ppm in earthworms in New York. Less than 1% of water samples from adjacent aquatic habitats had
dicofol residues greater than the detection limit (0.005 ppm). However, no water chemistry, location,
or weather data was provided to determine whether residues reached water or if they dissipated in
the waters. While dicofol residues were detected in the various sampled compartments, including
eggs of different species, concentrations of DDE were much greater (often by 1 to 2 orders of
magnitude).
Although the monitoring studies had data gaps that would have aided in interpreting the
environmental concentrations in various compartments, results lend support to laboratory studies
which suggest that while dicofol is likely to persist in the monitored environments with half lives
ranging from 2 to 4 months, it is not as persistent as DDT or DDE. The results of this study have
, been used to compare modeled estimated environmental exposures to concentrations of dicofol that
may be expected under "typical" use conditions and were helpful in the characterization of the risk
associated with dicofol use.,
n MI H " i ii
b. Terrestrial Exposure Assessment
: 'III ,,
Table 14 estimates the maximum estimated environmental exposures (EECs) likely to occur on
mammalian and avian foods immediately following application. This exposure estimate is based on
the methods of Hoerger and Kenaga (1972)3 as modified by Fletcher et al. ,(1994)4.
Table 14: Estimated Environmental Concentrations on Avian and Mammalian Food Items (ppm)
Following a Single Application at 1 Ib. ai/A (Hoerger and Kenaga, 1972, as modified by Fletcher et al,
1994) . ^__ .
[EEC (ppm) . EEC (ppm)
Food Items
Sljgrt grass
Tall grass
SU, . '. ,', ' . ,1,'KI1.1 , " ' ' , ' " ,' '; " . '
Broadleaf plants and small insects
Fruits, pods, seeds, and large insects
Predicted Maximum Residue
240 ' ';' ' ' \ , '
110
,' . ; / , ปi i , i ' ',,', "iij ,| ' i^ , , iiiii,;^,, :i>
135
'" n ,'"'
15
Predicted Mean Residue
85 -,.,.'
36
45
7
' .' ''"'
|,'(, .I,';.
3 Hoerger, F.2 and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of
representative data as a basis for estimation of their magnitude in the environment. In F. Coulston
and F. Korte, eds., Environmental Quality and Safety: Chemistry, Toxicology, and Technology,
Georg Thieme Publ, Stuttgart, West Germany, pp. 9-28.
4 Fletcher, J.S., I.E. Nellessen, and T.G. Pfleeger. 1994. Literature review and evaluation of
the EPA food-chain (Kenaga), nomogram, an instrument for estimating pesticide residues on plants.
Environ, tox. Cheni. 13:1383-1391. "'' ' " '"" 'r" ''!'" ' "'' "' "'' '" ' ' ":
-------
Uncertainties in the terrestrial EECs are primarily associated with a lack of data on interception
and subsequent dissipation from foliar surfaces. Based on these estimates, maximum exposures range
from 96,to 1,920 ppm on short grass, 44 to 880 ppm on long grass, 54 to 1,080 ppm on broadleaf
plants, and 6 to 120 ppm for fruits and seeds. Highest exposures occur on citrus, while the lowest
typically occur from the lawn and turf use. .
Comparison of Modeled EECs With Field Residue Monitoring Data
Table 15 summarizes the highest geometric mean concentrations of p,p'-dicofol in eight
matrices, foliage,'grass, soil,'small mammals, terrestrial invertebrates, reptiles/amphibians, birds, and
fish, collected over three years of testing in the field rnonitoring studies.
Table IS; Three-year mean p,p'-dicofol concentrations (ppm)1 in selected biotic and abiotic matrices.
State Site* Foliage Grass Soil Mammal Terr. Herps Birds Fish
Invert.
CA
FL
NY
C
NC
C
NC
C
NC
.92
0.6
74
- 5.9
97
5.2
.. NG3
0.5
78
9.7
48
5.2
0.-3
0.1
0.5
0.1
0.6 (21d)
.0.1
0.8
0.1
1.4 ,
0.1 (7d)
1.1
0.3 (7d)
3.9
0.2
2.1
0.8
.1.7
0.5
0.9
; 0.6
3.8 ' .
.0.5 (7d)
2.2 (7d)
0.4 (21d)
NT4
0.1
NT
0,9
NT
0.1
NT
0.04
NT
0.5 (7d)
NT
0.2 (7d)
1 All means are calculated from 0-day concentrations, except where rioted in parentheses'after the mean.
2 C= crop area; NC= non-crop area . ,
3 NG= Not collected because no grass present on treated area.
4 NT= Not taken for crop areas.
i
In general, p,p'-dicofol concentrations in treated crop and adjacent non-crop areas were
considerably lower than those predicted by Fletcher et al. (1994). Residue concentrations were
variable and declined exponentially after application. The highest mean concentrations were typically
found immediately following application on the treated area, usually on the treated crop foliage,
except for the Florida citrus site. Residues of p,p'-dicofol on the non-crop area were typically 1 to 2
orders of magnitude below those found in the crop areas. In the crop areas, the highest mean
concentration jDfp,p'-dicofol measured in the abiotic matrices were 97 ppm for foliage (New York),
78 ppm on grass (Florida) and 0.56 ppm for soil (New York). The highest mean concentration of
p,p'-dicofol measured in the abiotic matrices for the non-crop area were19.7 ppm for grass (Florida),
5.9 ppm on foliage (Florida), and 0.1 ppm for soil (California and Florida).
Foliage residues in the crop areas declined from 3-year means of 92, 97 and 74 ppm
immediately after application, to 0.05, 16 and 24 ppm 90 days later for cotton, orchards, and citrus,
respectively. Dissipation half-lives for cotton, orchard, and citrus foliage were 9, 41, and 61 days,
respectively. Grass residues declined from 3-year means of 48 and 78 ppm immediately after
: . 79 ,
-------
application, to 0.15 and 2.3 ppm 90 days later for orchards and citrus, respectively. Dissipation half-
lives of p,p'-dicofol on orchard and citrus grass were 12 and 21 days, respectively.
Foliage residues in non-crop areas declined from 3-year means of 0.6, 5.2, and 5.9 ppm
immediately after application to 0.09, 0.9, and 0.55 ppm after 90 days for cotton, orchards, and
citrus, respectively. Mean grass residues declined from 0.47, 5.1, and 9.7 ppm immediately after
application, to 0.042 0.08, and 0.54 ppm 90 days later for cotton, orchards, and citrus, respectively.
ii I i. ;..;. :/, ':,-%::>"V ,: "..',,, \:W Eii: .,'?,''":!' >: :**? ''<.::.'.',.;'> ,"?;;;;:> "Ml,. i. i :,i ,. 1 :>$'?.'
In crop areas, the highest mean concentrations of p,p'-dicofol measured in the biotic matrices
were 1.4 ppm for small mammals (Florida), 3.9 ppm for terrestrial invertebrates (California), and 38
ppm for reptiles/amphibians (Florida). In non-crop areas, highest mean concentrations were 0.3 ppm
for small mammais (New York), 0.76 ppm for terrestrial invertebrates (Florida), 0.38 ppm for
reptiles/amphibians (Florida), 6.9 ppm for birds (Florida), and 0.26 ppm for fish (Florida).
c. Water Resource Assessment -
i. Ground Water Assessment
' ".i iif-, i':,!:1. .. ," : ',1 ,:, '.MI- ,'. ' :,;(;- .'.i,1 .;;.',', "j;,: ,,-,' , ;, /, ^ ;'i,-, ,
Laboratory data suggest that dicofol, with moderate to low mobility and moderate persistence,
is not expected to leach significantly. This is supported by the two terrestrial field dissipation studies
conducted in California. While mobility data for dicofol degradates/metabolites are not available, no
movement of the major degradates was observed in the field studies. The weight of evidence from
the environmental fate and transport data suggest that dicofol is not expected to leach extensively to
groundwater under normal use conditions.
f Pesticides in Ground Water Database A Compilation of Monitoring Studies: 1971-1991
National Summary. Published in September 1992. EPA 734-12-92-001.
The ]EPA Pesticides in Ground Water Data Base5 shows no detections of dicofol in limited
sampling in California, Georgia, Hawaii, and Texas (1,634 wells sampled between 1979-1991).
Howard (1991) refers to a report of dicofol concentrations of 6.2-1.8 ppb in ground water wells from
a hazardous waste site in Dade County, Florida. This incident may have been the result of point
source contamination rather than pesticide use.
ii. Surface Water Assessment
I
i, II * I
Dicofol can contaminate surface water from spray drift applications. Substantial fractions of
dicofol may be available for ranoff for several days to weeks after application, depending on the
isomer and field soil conditions, intermediate soil/water partitioning of dicofol indicates that the
chemical will move in runoff, both dissolved in runoff water and adsorbed to eroding soil.
Once dicofol reaches surface waters, it will be susceptible to rapid hydrolysis in neutral to
alkaline waters, even water bodies such as ponds where water turnover is slow. However, dicofol
80
-------
is stable to hydrolysis in acidic waters and is only moderately susceptible to biodegradation under
aerobic and anaerobic conditions. Volatility and Henry's Law constant data suggest that dicofol has
a low potential to volatilize from water. Because of these characteristics, dicofol may be substantially
more persistent in acidic than neutral or alkaline waters, particularly where water turnover is slow and
microbial populations are low. , ,
An intermediate soil/water partitioning coefficient suggests that substantial fractions of dicofol
will be adsorbed to suspended and bottom sediment. While the concentration of dicofol in suspended
and bottom sediment will be greater than the concentration in the water column, the mass of dicofol
in the water column will generally be greater in the sediment. The reported BCFs for p,p'-dicofol in
the bluegill sunfish indicate that dicofol has significant bioaccumulation potential.
. Limited fate data on the major transformation products of dicofol, primarily terrestrial field
dissipation studies, indicate these products may exhibit intermediate to high soil/water partitioning.
Consequently, adsorption to eroding soil probably represents a maj or component of degradate runoff.
The importance of dissolution in runoff water to overall losses of dicofol degradates due to runoff
will probably vary.from substantial, for any with intermediate soil/water partitioning, to little for any
with high soil/water partitioning. "
In the three-year, three-state monitoring studies (see a. vi. above), less than 1% of water
samples collected from aquatic habitats adjacent to treated fields contained p,p'-dicofol residues above
the reporting limit (0.005 ppm). Maximum dicofol concentrations reported for sampled surface water
adjacent to treated citrus groves in-Florida ranged from 21 ppb at the time of application to 140 ppb
7 days after application, and up to 52 ppb 90 days after application. The annual time-weighted
average geometric mean concentrations for the surface waters in all 3 study areas (California, Florida,
and New York) ranged from 0.4 to 1.1 ppb. Low level of residues of p,p'-dicofol were measured in
fish. The monitoring studies were not specifically designed to determine EEC's extent for drinking
water, assessments on a national scale. In particular, the frequency of sampling is not adequate to
provide peak concentrations for acute risk assessments. However, the study results are useful in
evaluating the screening-model assessment. In this case, model results are compandable (in the same
range) to the monitoring data. '
In a South Florida Water Management District6 study of samples collected regularly from 27
surface water sites between 1988 and 1993, dicofol was not detected (above detection limits generally
ranging from 0.002 to 0.18 ppm) in any of the samples. The Agency does not have any other data
on dicofol in surface waters, ''.-.'
6 Miles,. C. J. and R. J. Pfeuffer. 1994. Pesticide Residue Monitoring in Sediment and Surface
Waters. Technical Publication-December, 1994. South Florida Water Management District.
81
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mi i P i
d. Aquatic Exposure Assessment
Based on laboratory data, the Agency has characterized dicofol as very highly toxic to both cold
and warm water fish species and aquatic invertebrates. As such, the Agency is concerned about any
direct and/or indirect contamination of aquatic environments from the use of dicofol.
i. Direct Contamination
AU current dicofol labels allow for aerial application. Because many registered uses of dicofol
are grown in close proximity to aquatic habitats, and because of the variety of topographical and
geographical features under which many of these crops are grown, the Agency believes it is
reasonable to assume that direct contamination to aquatic environments will occur. The aquatic
estimated environmental concentrations (EECs) likely to occur in a 6 inch layer of water that is
directly exposed to an application of dicofol are based on the Dewitt nomograph. EEC range from
a fyl!1 of2:94 PPm for nut fr668 to 0.25 ppm for the lawn and turf use pattern. These EECs were used
to calculate acute risk quotients for fish resulting from exposure to a direct application of dicofol to
a surface water body.
ii. Indirect Contamination (Runoff/Drift)
GENEEC is a screening model that provides an upper-bound EEC on a high exposure site. The
program uses basic environmental fate values and pesticide label information to calculate EECs in a
1 -hectare, 2-meter deep pond following treatment of a 10-hectare field. The runoff event occurs two
days after the last application.. GENEEC takes into account adsorption to the soil or sediment,
incorporation of the pesticide, degradation in soil before runoff, and degradation within the water
body. Dicofol fate parameters used in the model were soil Koc (60), solubility (1.32 ppm), and half-
lives for aerobic soil metabolism (43 days), hydrolysis (64 hrs), water photolysis (4 days), and aquatic
me*ฐ^sn! (stable): The, roode! assumes Direct deposition of 5% of the application rate for aerial
spray applications and 1% for ground spray applications.
Table 16 lists the aquatic EECs likely to occur from runoff and drift, as predicted by the
GENEEC model. Based on the maximum label application rates, and assuming 2 applications with
an average 3ti-day interval between applications, peak EECs (i.e., a rain immediately following
application) range from 2.4 ppb on turf to 28.6 ppb on nuts. The GENEEC model also predicts that
d',c^9I.^!^ei5..l^.!1. dec]ine fairly rapidly and that by day 56, aquatic residues will be less than 2 ppb.
Apples, citrus, pears, and quince, with label application rates of 3 Ib ai/acre, applied twice at 30-day
intervals, had peak EECs of 18.3 ppb and 56-day EECs of 1.1 ppb.
82
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Table 16: Aquatic EECs of dicofol by crop, as predicted by the GENEEG model.
Crop
Apples
Beans(Cal).
Beans
Citrus
Cotton
Cucurbits
Grapes
Hops
Lawn/Turf
Mint
Nuts
Ornamental
Pears
Peppers
Quince v
Strawberry
Tomatoes
Rate
(Ib ai/A)
3.0
1.5
0.5 ^
3.0
' 1.5
0.625
1.165
1.165
0.4
1.25
4.0
0.45
3.0
0.75
3.0
'2.4
0.75
No. Interv.
(Days)
2
2
2
2
2
2
2
2
2
1
2
2
2
2
.. 2
2
2
30
30 .. .
30
30
30
30
30
30
30
30
30
30
30
30
30 .
30
PeakGEEC 4DayGEEC 2 Way , ' ' 56DayGEEC
(ppty Cppb) 'GEECfoob)' fanh)
18.3
9.2
3.0
18.3
10.7
3.8
7.1,
8.3
2.4
4.2
28.6
2.8 '
18.3
4.6
'l8.3
14.6
4.6
11.9 .
6.0
. 2.0
11.9
7.2
'2.5
4.6
5.6
1.6
. 2.7
19.1
1.8 ' '.
11.9
3.0
11.9
9.5
3.0
2.9
1.4
.0.5
2.9
,1.8
0.6
1.1
"1,4
. 0.4
0.6
4.8
0.4 . .
2.9
. ' 0.7
2.9
2.3
0.7
LI
0-5
0.2
1.1
0.7
0.2
; 0.4
0.5
-o.i
, . 0,2
1.8
0.2
1.1
0.3
1.1
- Q.9
0.3
2. Ecological Effects Characterization
The Agency has adequate data to assess the hazard of dicofol to nontarget terrestrial organisms.
Toxicity testing reported in this section does not represent all species of bird, mammal, or
aquatic organism. Only two surrogate species for both freshwater species and birds are used to
represent all freshwater fish (2,000+) and bird (680+) in the United states. For mammals, acute
studi es are usually limited to the Norway ,rat or the house mouse. Estuarine/marine testing is usually
limited to a crustacean, a mollusk, and a fish. Also, neither reptiles nor amphibians are tested. The
assessment of risk or hazard makes the assumption that avian and reptilian toxicity are similar. The
same assumption is used for fish and amphibians. . -
83
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a.", Toxicity to Terrestrial Animals
i i ii
i. Birds, Acute and Subacute
In order to establish the toxicity of dicofol to birds, the following tests are required using the
technical grade material: one avian single-dose oral (LDSO) study on one species (preferably mallard
;\0r]?pb.white quai]); two subacute dietary studies (LC50) on one species of waterfowl (preferably the
mallard duck), and one species of upland game bird (preferably bobwhite quail)
Dicofol is moderately toxic to avian species on an acute oral basis and slightly toxic on a
subacute dietary basis. The guideline requirements are fulfilled.
Table 17; Avian Acute Oral Toxicity Findings
Species % A.l.
Ring-necked pheasant 87.8
i,',l! ' I" '",!'
Table 18: Avian Subacute Dietary
Species % A.I.
Northern Bobwhite 99
Mallard 99
Pheasant 99
LDM MRIDNo.
mg/kg Author/Year
265 Hudson etal. 1984
160000
Toxicity Findings
LCsoppm MRIDNo.
Author/Year
3010 GS0021007
Hill etal. 1975
1651 GSQjmOO?
Hilletal!, i975
2126 GS0021007
Hill et al., 1975
Toxicity
Category
moderately
toxic
" - ' ' ' ' "
; ' "i;: ' ''"' ' ; : ;
Toxicity
Category
slightly
toxic
slightly
toxic
slighdy
toxic
'"M i r , ', ill, i ' ,,1'im , ' ill.il'1 ll!|i .'Vnjll,':!. IlilulfL ', i,,:1', ,1
Fulfills Guideline
Requirement
yes
"'' ' . - ;>' .'' I'1 '' ' '
'' ;;''"::"':' "'''' '"' ! ": ' '*'' ':
Fulfills Guideline
Requirement
yes
yes
yes
ii. Birds, Chronic
i MI ' ' ii
, i i'i
Avian reproduction studies are required when birds may be exposed repeatedly or continuously
through persistence, bioaccumulation, or multiple applications, or if mammalian reproduction tests
indicate reproductive hazard. Because dicofol is persistent and has the potential to bioaccumulate
in the environment^ chronic reproduction testing is required.
84
-------
Table 19: Avian Reproduction Findings
Spedies
NOAEC1 LOAEC Endpoints affected MRlDNo.
ppm
ppm1
Author/Year .
Fulfills Guideline
Requirement
Northern
Bobwhite
Mallard Duck .
American
93
93.3
93
120
<10
1
120
10
3
no effects
, .
v cracked eggs, shell
strength
. thinned egg shells;
40042055;
42003501
41231301
41934001;
yes
yes
yes
kestrel
Screech-Owl 93
Ring-Dove
98.8 - <40
Mallard Duck Tech.? 10
reduced shell
thickness
10 egg shell weight
and thickness
40 egg-shell thickness;
cracked eggs; egg
production
10' no effects
42268701
Wiemeyer et yes
al., 1989
Schwarzbach yes
etal.,1988
Hill, Heath & Supplemental
Spann, 1975
GS 002007 .
1 NOAEC = No Observed Adverse Effect Concentration; LOAEC = Lowest Observed Adverse Effect
Concentration - .
Avian Reproduction Data Overview
Schwartzbach et al.(1988) fed dicofol (or its metabolites) contaminated feed to ring doves
(Streptopelia risoria) for 90 consecutive days. They found that dicofol concentrations in egg yolks
ranged from 2.62 to 22.58 ppm and that dietary concentrations as low as 40 ppm caused statistically
significant differences in egg-shell thickness, cracked eggs, and egg production and that treated birds
produced a mean of 1.88 eggs per clutch as compared to 1.97 eggs per clutch produced by the
control birds. In addition, 16.9% of all eggs produced by the treated group were either broken or
cracked, as compared to 5.7% of eggs produced by the control group. The principle metabolite of
dicofol, DCD, did not produce thinning of eggshells and did not metabolize well to DCBP or DCBH.
The authors also reported that egg-shell thickness became progressively thinner with increasing time
of exposure to the dicofol diets and that concentrations of dicofol in ring dove eggs were significantly
correlated with egg-shell thinning. :,
Wiemeyer et al. (1989) found that egg-shell weight and thickness were adversely affected ih
screech-owls fed dicofol-treated diets at levels as low as 10 ppm. However, no statistically significant
differences existed between controls and treated birds for other reproductive parameters.
Beavers et al. (1989) conducted a one generation reproduction study with mallard ducks and
found that dicofol significantly reduced egg shell strength at 40 ppm, but caused no statistically
85
-------
Piii'l
I ijitii i _'! ;n iiji/iji | ii ' n ii i | n ' ' , I',' ' ( , , ' i i ',
significant differences in other parameters, such as eggs laid, eggs hatched, and 14-day survivors
:;| ..... ;::(Ng|p34J^ Spann (1973) fฐun'd that dicpfpl (Kelthane) had no effect
orijhe nuiiiJDer ojFeggs laid, the number of eggs cracked, or the number eggs embryonated and 3-week
;'| " ^ernbryos,1" when mallard ...... ducks were fed 5 and 10 ppm in th"eir diets|GSOb21014). Based" ontKese
data, Heath and Spann concluded that relatively low levels of Kelthane (5 and 10 ppm) had no
significant effect on mallard reproduction.
1 1 1 1 1 . i i , i i
Frank etal. (1986) conducted a one generation (19- week exposure) reproduction study with
bobwhite quail fed dietary concentrations of dicofol at 30 and 120 ppm (MRID 40042055). Some
of the reproductive parameters measured included the number of eggs laid, cracked eggs, shell
thickness, eggs set, viable embryos, hatchlings, and 14-day survivors. No statistically significant
effects, relative to the control birds, were found for any of the reproductive parameters measured.
Avian reproductive studies indicate that dicofol, at least for certain species, can affect such
avian reproductive parameters as shell strength, shell thickness, and egg production. The guideline
requirements are fulfilled.
\
Some of these studies may have,been conducted with dicofol material, which still had higher
levels of DDT (greater than the current requirement to have less than 0.1% DDTr impurities).
iii. Avian Field Studies
Based on its structural similarity to DDT, its persistence, and its potential to bioaccumulate, and
several laboratory studies that showed dicofol caused eggshell thinning at very low levels of dietary
exposure, the Agency presumed that dicofol could cause reproductive impairment to avian species.
This presumption of hazard prompted the Agency to issue a Data Call-in (DCI) in order to collect
residue data and other information that could be used to assess the hazard and potential risk to avian
species under actual field conditions.
In multi-year, multi-crop field residue monitoring studies in California, New York and Florida,
dicofol residues were analyzed in various biotic and abiotic matrices on treated crop areas and
adjacent habitats. Eggs were collected from thirteen avian species and were analyzed for residues and
eggshell thickness (MRIDs 41764801, 41764802, 41845601, 41845602, 41845603, 42285501,
42285505, and 42721302). These data were compared with the nesting success for these species.
86
nil
On me otHer hand, Clark et al. (1990) studied me effects of dlcpfol on American kestrel
reproductive parameters through two breeding seasons (MRID ^j^^ooi) and found that dicofol
caused egg-shell thinning, lowered the thickness index at dietary concentrations of 3 ppm, and
reduced shell weight at 1 0 ppm. All changes were dose-related. However, although these parameters
were affected, there was no evidence that these changes had any serious effects on the production of
young. These authors concluded that dicofol was equal to or less effective than DDE as a shell-
thinning agent. These same authors also concluded that before it was possible to fully determine the
ecological effects of dicofol, actual field studies on wild bird populations must be conducted.
-------
Yearly geometric mean p,p'-dicofol residues ranged from 0.0027 ppm (several species in
California) to 0.46 ppm (American robin eggs in New York). Yearly means were highest in New
York (0.01-0.46 ppm), and lowest in California (
-------
Table 21: Mammalian Reproduction Findings
Species %A.I. NOAEL1 LOAEL1 Endpoints MRIDNo. Fulfills Guideline
ppm ppm affected* Author/Year Requirement
Rat 93 5 25 ' A3,C,p,E> 41806601 Yes
1 NOAEL = No Observed Adverse Effect Level; LOAEL = Lowest Observed Adverse Effect Level ~~~,,,
2 A: reduced viability of pups; B: increased number of stillborn pups; C: pup deaths; D: total li tter loss; E: weight
reduction; F: vacuolation in ovaries.
I"! , 11'liij i I i in i
"ii , i li "i p i i1
111 ' ' , ,!, v. Insects
A honey bee acute contact LD50 study is required if the proposed use will result in honey bee
exposure. .
Mir , n 'ป , in ' v i " ' , , , i ,, i - 'hii,,,: ' i1 ! , 'I " , . 'i ,. , ,i * I. ' ,,,'
i,i 'li ii ',, , ' ." ", ! '" "|" i r . ', ' , ' MI, "'' ' ' Jiliii i if i 'i|, ' , i, , , i1. i, i '",, Hi, ;i " f
Dicofol is slightly toxic to bees. The guideline requirement is fulfilled.
Table 22: Nontarget Insect Acute Contact Toxicity Findings
Species %AI LDso^g MRIDNo. Toxicity Fulfills Guideline
a.i./bee Author/Year Category Requirement
Honey Bee Tech. >50 ID05001991 slightly yes
"., ' .' :.... ". ', . ' toxic
b. Toxicity to Aquatic Animals
i. Freshwater Fish
In order to establish the toxicity of a pesticide to freshwater fish, the minimum data required
on the technical grade of the active ingredient are two freshwater fish toxicity studies. One study
should use a cold water species (preferably the rainbow trout), and the other should use a warm water
species (preferably the bluegill sunfish).
I I li I ," i (
Results of the 96-hour acute toxicity studies indicate that dicofol is highly toxic to freshwater
fish. The guideline requirements are fulfilled.
88
-------
Table 23; Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
Bluegill sunfish
Channel Catfish
Fathead Minnow
%A.L :
93.3
Tech.
Tech.
93.3
LC50ppm
a.i.
0.124
0.51
0.36
0.50
MRIDNo.
, 41i595401;42468201
GS0021004
GS0021003
GS0021018
Toxicity t
Category
highly toxic
highly toxic
highly toxic
highly toxic
Fulfills Guideline
Requirement
yes
yes .
yes
yes
Data from fish early life-stage tests or life-cycle tests with aquatic invertebrates (on whichever
species is most sensitive to the pesticide as determined from the results of the acute toxi city tests) are
required if the product is applied directly to water or expected to be transported to water from the
intended use site, and when the pesticide is intended for use such that its presence in water is likely
to be continuous or recurrent regardless of tbxicity; or if any acute LC50 or ECSO is greater than 1
mg/L; or if the EEC in water is equal to or greater than 0.01 of any acute EC50 or LC50 value; or if
the actual or estimated environmental concentration in water resulting from use is less than 0.01 of
.any acute EC50 or LC50 value and any of the following conditions exist: studies of other organisms
indicate the reproductive physiology offish and/or invertebrates may be affected, physicochemical
properties indicate cumulative effects, or the pesticide is persistent in water (e.g. half-life greater than
4 days).
Results indicate that dicofol can affect the early life-stages of freshwater fish. The guideline
requirement is fulfilled. ,
- [ "
The fish life cycle test is required when an end use product is intended to be applied directly to
water or is expected to transfer to water from the intended use site when any of the following
conditions apply: the EEC is equal to or greater than one-tenth of the NOAEL in fish early life stage
or invertebrate life cycle test or if studies of other organisms indicate reproductive physiology offish
may be affected.
Table 24: Fish Early Life-Stage Toxicity Findings
Species
% NOAEC LOAEC MATC' MRIDNo.
AJ (ppb) (ppb) (ppb)
Endpoints Fulfills Guideline
Affected Requirement
Freshwater: 93. 1.0
Rainbow trout 3
Freshwater: >9 , 4.6
Rainbow Trout 5.5
>4.4 42000601; growth Supplemental
<7.9 42063001
9.1
6.5
43383902 growth Yes
1 MATC = Maximum Allowed Toxic Concentration, defined as the geometric mean of the NOAEC and LOAEC.
89
-------
Dicofol can affect the reproductive physiology of the fathead minnow at levels as low as 5.5 ppb
(mean hatching success). The guideline requirement is fulfilled.
Table 25: Fish Life-Cycle Toxicity Findings
Species
Fathead
minnow
% NOAEC LOAEC MATC ' MRID No
i j^*j* Cppb) \ppb) (ppy)
93.3 2.75 5.5 6.31 42628901;
43162001
' "
ii. Freshwater Invertebrates
Endpoints
Affected
growth;
spawning;
Fulfills Guideline
Requirement ,
yes
, , , , , , , , ,,,,,
Minimum testing required to assess the hazard of a pesticide to freshwater invertebrates is a
freshwater aquatic invertebrate toxicity test, preferably using first instar Daphnia magna or early
instar amphipods, stoneflies, mayflies, or midges.
I
I s I III I I i 11
There is sufficient information to characterize dicofol as highly toxic to aquatic invertebrates.
The guideline requirement is fulfilled.
i in i
Table 26; Freshwater Invertebrate Toxicity Findings
Species
\
III , ,
Daphnia magna
\\
i
96 AJ.
iปi
M
93.3
EC50
(mg/l)
\
0.14
MRIDNO.
Author/Year
I, i
40042057; 40098001;
" 42003502
Toxicity
Category
i"n
highly toxic
Fulfills Guideline
Requirement
ii
i
yes
ik
Hi. Estuarine and Marine Animals
^.cute toxicity testing with estuarine and marine organisms is required when an end-use product
is intended for direct application to the marine/estuarine environment or is expected to reach this
env|ronment in significant concentrations. Because use of dicofol on apples, citrus, and cotton may
result in exposure to the estuarine environment, testing of estuarine and marine organisms is
i II'ITIE , :, . L ' " " ' ' " ....,-.., 1? .
appropriate.
ni1', . "i! ' i , ' ;, , '" i" !
The requirements under this category include a 96-hour LC50 for an estuarine fish, a 96-hour
LCjo for shrimp, and either a 48-hour embryo-larvae study or a 96-hour shell deposition study with
oysters.""' " '' " :' '" " ' "' '" " "' ' '' " :"" '"' ' '.'
Sin ; i . '- 'I'lilf'll1! ; ' rill1," /..i-/1, >:""'_ _ '.- "')!: ' : ;!! "'.-, ".'"-"'', _ : ,..'". . '. '.M. 1; /. .,(; i-.|,,,i i. / i|ii ..JMJ, .; ป ",-
There is sufficient information to characterize dicofol as being highly to very highly toxic to
estuarine/marine organisms.
I II
I I
90
-------
Table 27: Estuarine/Marine Acute Toxicity Findings
Species
Eastern oyster
embryo larvae
Mysid Shrimp
Sheepshead
minnow
%'AJ. ,LC5
-------
:* 'SiiiiiH1,,11 IJK '"it'1 iiissiiS1'1'ป.*' "" i.:>' ' "' "i *F \
-------
Table 28: RQ Calculations, LOCs and Risk Presumptions for Terrestrial Animals
Risk Presumption RQ' '. LOC
, . '..'. Birds "
Acute High Risk 'EEC'/LCSO or LD50/sqft2 or LD50/day3 . 0.5
Acute Restricted Use EEC/LC50 orLD50/sqftorLD50/day (orLD50 0.2
Acute Endangered Species ' <5Qmg/kg) . -' 0.1
Chronic Risk EEC/LC50 orLD50/sqftorLD50/day ; 1
EEC/NOAEC
. Wild Mammals - ' -
Acute High Risk EEC/LC50 orLD50/sqftorLD50/day 0.5
Acute Restricted Use EEC/LC50 orLD50/sqftorLD50/day (6rLD50 0.2
Acufe Endangered Species <50mg/kg) 0.1
Chronic Risk EEC/LC50 orLD50/sqftorLD50/day 1
. EEC/NOAEC .' ' ,__
abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items
i
2 mg/ft2 3 mg of toxicant consumed/dav
LD50 * wt. of bird . LD50 * wt. of bird
Table 29: RQ Calculations, LOCs and Risk Presumptions for Aquatic Animals
Risk Presumption. ' RQ - LOC
Acute High Risk . EECVLC50 or EC50 0.5
Acute Restricted Use . EEC/LC50orEC50 0.1
Acute Endangered Species EEC/LC50 or EC50 0.05
Chronic Risk ' EEC/MATC or NOAEC ' i
1 EEC '= (ppm or ppb) in water
Table 30: RQ calculations, LOCs, and risk assumptions for Plants
Risk Presumption
Acute High Risk
Acute Endangered Species
. Acute High Risk
Acute Endangered Species
RQ
Terrestrial and Semi-Aquatic Plants
EECVEC25
EEC/EC05 or NOAEC
Aquatic Plants
. EEC2/EC50
EEC/EC05 or NOAEC
LOC
1
1
,
i
i
EEC = lbsai/A
EEC = (ppb/ppm) in water
93
-------
For this ecological risk assessment, results of the ecotoxicity data are compared first with
modeled estimated environmental concentrations (EECs) derived from terrestrial exposure (see l.b
in this chapter) and aquatic exposure (see l.d in this chapter). This provides a screening-level
assessment of the potential for the use of dicofol, at maximum application rates, to pose a risk to the
assessed organisms. The ecotoxicity data are also compared with results of a multi-year ecological
monitoring data conducted on citrus in Florida, cotton in California, and apples in New York The
levels of dicofol found in this study represent likely concentrations of dicofol under typical use
conditions in these ^j^v.j|^^.^ence^^ej^eie.n.jie.isiซ| comparisons and the implications on the
ecological rislc assessment are discussed in the risk characterization that follows this section.
a7 Exposure and Risk to Nontarget Terrestrial Animals
i. Avian Hazard Assessment
11 i inn i i mi i i i ii i i i i d
Table 31 shows maximum and mim'mumayian dietary risk quotients for all currently registered
Uses of dicofol. Both
Table 31: Maximum ai
lllllllll J LI 1 L Ii ซ ""!
* quotients for dicofol.
Crop
\
Apple
Beans
Beans (CA)
Citrus
Cotton
Cucurbits
Grapes
11 1 1 1
Hops
Lawn & Turf
Mint
Nuts
Ornamentals
Pears
, ,' : Peppers
Rate
(Ib
al/A)
' .:
3
0.5
1.5
3
1.5
0.625
1.165
1.165-
0.4
1.25
4
0.4
3
0.75
acute and chronic dietary
ad minimum estim
IC50
(ppm)1
" .. .".. ,,
1651
1651
' 1651
1651
1651
1651
1651
1651
1651
1651
1651
1651
1651
165i
LOAEC
(ppm)2
3
3
3
3
,.' 3
c i.
3
3
3
1" "i !!ii.i,.ป .
', \: 3
3
3
3
3
3'
atedenvin
Max.
EEC
(PPm)' '..
720
120
360
720
360
,>i, >:' '. ic'i.1.
150
279.6
279.6
., . .' H'" t, ' 'i,,li 'ป,'
96
300
960
96
720
180
risk quotients are presented.
jnmental i
Min.
EEC
(PP)3
' '
, -
21
3.5
10.5
21
10.5
1,, | |,,"ii 'V,
4.375
8.155
,," ifl-i'i "' " '", !
8.155
2.8
8.75
28
2.8
21
5.25
concentn
Max.
Acute
D.O
S\.\s
EEC/
LC50
0.44
0.07
0.22-
0.44
0.22
.'.-i, vป .1
0.09
0.17
0.17
0.06
0.18
0.58
0.06
0.44
0.11 "
itions an
Min.
Acute
RQ
EEC/,
LC50
oil
0*00
0.01
0.01
0,01
')', ; ซ!!-,.
o.oo
0.00
0.00
o.bo
0.01
0.02
0.00
0.01
o7o6
id avian dietary
Max.
Chronic
RQ
EEC/
LOAEC
240
* 40
120
240
120
:, i ,i, ?;,, ,i;;n.
50
93.2
93.2
32
100
320
, , ', 32. '
240
60
risk
Min.
Chronic
RQ
EEC/
LOAEC ' ,, .... .'.'! '. I," , .'.."."
7.0 : |V| _,;
' ' 1.2 ^
3.5
7.0
;. , 3,5
, , '' ! '' ' : ';. , ii,' * i [ iJ,"1.."!!".,!'.'''!!!,' ป "ซป!: ' '.III"*!*' " , :''. /'iBi
1.5
2.7,
2.7
i i t
0.9
.2.9
9.3 ^
0.9
7.0 - ' '..' ' _..
1.8
94
-------
Table 31: Maximum and minimum estimated environmental concentrations and avian dietary risk
quotients for dicofol.
Crop
Quince
Strawberries .
Tomatoes
Rate
(Ib
ai/A)
3
0.8
0.75
LC50 LOAEC
(ppm)1 (ppm)2
- . '
1651 3.
1651 3
1651 3
. Max.
EEC
(ppm)2
720
192
180
Min.
EEC
(ppm)3
21
5.6
5.25
Max.
Acute
RQ .
' EEC/
LC50
0.44
0.12
0.11
Min.
Acute
RQ
EEC/
LC50
0.01
0.00
0.00
Max.
Chronic
RQ
EEC/
LOAEC
240
64
60
Min.
Chronic
RQ
EEC/ :
LOAEC
7.0
1.9
1.8
1 LC50 value for mallard duck (GS0021007). ; s
2 LOAEC value for American kestrel (MRID#s 41934001; 42268701)
3 Maximum EECs on avian food items based on Fletcher et al (1994) for short grass (see Table 14).
4 Minimum EECs on avian food items based on Fletcher et al (1994) for fruits and seeds (see Table 14).
(a) Avian Acute Risk
Maximum risk quotients (based on short-grass EECs) ranged from 0.06 for lawn and turf use
to 0.58 for use on nut trees. No minimum acute risk quotients (which were based on EECsfor fruit
and seeds) exceeded 0.02. Only nut tree use, at an application rate of 4 Ib a.i./acre, exceeded the
maximum acute high risk LOG of 0.5. Based on these risk quotients, the only use patterns that
exceed the LOG to non-target avian species, on an acute dietary basis, are citrus and nuts.
In general, Table 31 shows that acute risk (in the form of direct mortality) to non-target avian"
species from exposure to dicofol only exceeds the LOG (0.5) from exposure to short grass. Since
few avian species feed solely on short grass, the likelihood for any large scale hazard to numerous
species appears unlikely. Still, certain species (i.e., geese and ducks) may be at risk because of their
feeding habits. '
(b) Avian Chronic Risk Based on Laboratory Data
Chronic risk quotients in Table 31 were determined by establishing, a ratio between the
maximum and minimum EEC and the lowest observed adverse effect level (LOAEC) as determined
in the avian reproductive tests (in this case, 3 ppm for the kestrel). Maximum risk quotients ranged
from 32 for the lawn and turf and ornamental uses; to 320 for the nut, tree use. Minimum risk
quotients ranged from 0.9 for the lawn and turf and ornamentals use, to 9.3 for nut tree use.
In summary, the risk quotients suggest that chronic hazard, in the form of reproductive
impairment to avian species, is expected to exceed the Agency's LOG (1.0) for all the currently
registered dicofol use patterns. - '
95
-------
(c) Avian Chronic Risk Based on Field Data
in in i "ii ii
III I1 i in I 1 i ill i
Results of the avian reproductive studies, conducted under laboratory conditions, suggest that
effects of dicofol on avian reproductive parameters vary greatly. For example, NO AEC values for the
five avian species tested ranged from 1 ppm for the American kestrel (MRID #s 4193 4001,2268701)
to 120 ppm for the Northern bobwhite quail (MRID #s 40042055, 42003501). Similarly, LO AEC
valu.es, rapged from 3 ppm for the American kestrel to 120 ppm for the bobwhite quail If this
variation occurs under laboratory conditions, it is only reasonable to assume that it may also occur
under field conditions.
A comparison of the laboratory data with dicofol concentrations in the field studies suggests
that adverse avian reproductive effects from dicofol? in the form of egg-shell thinning, could occur.
However, correlations between egg-shell thickness and dicofol residue levels in the eggs were either
positive or near zero. In addition, egg-shell thickness from unsuccessful nests was actually greater
thai] thatjjn,successful .nestsin 9 of 12 species/regions. These data indicate that actual field
exposure/food chain contamination is either less than exposure regimes found in the laboratory to
cause adverse effects or that the effects are somehow being either mitigated or masked in the field.
Laboratory studies on kestrels (Clark et al., 1990) report adverse effects on eggs at dietary
levels of 1.7 ppm. Although measured field residue concentrations of p,p'-dicofol in the California
and New York monitoring studies were greater than 3 ppm, geometric mean egg residue levels were
at or below 0.02 ppm. No statistical correlation was found between dicofol residues and shell
thickness. At the levels of exposure measured in New York andCalifornia, no adverse reproductive
effects to American kestrels can be attributed to dicofol or any other chemical.
I I I 111 I I I "''. I' ipi !.u /ii",. 'iV . ;>l V , ii, ,.;i!|i,. .f,. i; if! i ," i,i. '! 'v 'J
Wiemeyer et al. (1989) reported adverse impacts on egg-shell weight and thickness in screech-
owls fed dicofol-treated diets at levels as low as 10 ppm (9.2 ppm wet wt). Field residue levels of
dicofol in Florida citrus ranged from 0.5 to 74 ppm in the cropped area and 0.1 to 9.7 ppm in the non-
crop area, high enough to affect both egg-shell weight and thickness in screech-owls utilizing this
area. In the 45 eastern screech owl eggs collected in Florida, eggshell thickness and weight decreased
significantly as p,p'-dicofol residues increased. However, eggshell thickness was greater in
Unsuccessful screectowl nests than in successful nfsts, suggesting that nesting success was not
adversely affected by eggshell thickness.
Geometric mง|n cpnc;entratiQns of p^'-dicofol in eggs and eggshell thickness for eight species
of birds from California, Florida, and New York were similar in both successful and unsuccessful
nests. In fact, egg-shell thickness for the unsuccessful nests was actually greater in 9 of the 12
species/regions while the geometric mean residues of p,p'-dicofpl in eggs from successful nests was
greater than unsuccessful nests for 6 of the 12 species/regions. These data suggest that exposure to
p,p'-dicofol residues did not result in eggshell thinning and had no other adverse reproductive impact
ii) the avjan populations studied. The only statistically significant difference (p<0.05) in the geometric '
mean egg residues between successful and unsuccessful nests was for the American Robin in New
96
-------
York. However, no significant correlations existed between p,p'-dicofol levels in eggs and eggshell
thickness. All correlation coefficients were very close to zero.
While actual effects were not demonstrated in the field monitoring study, the study was
designed to measure dicofol concentrations in various environmental compartments, not to test for
effects. The only conclusion that, can be drawn from the study is that, in some instances, the
concentrations of dicofol found in egg residues exceeded those levels that were found to cause
reproductive problem in laboratory studies.
ii. Mammalian Hazard Assessment
Table 32 shows the maximum and minimum mammalian dietary risk quotients for all the
currently registered uses of dicofol (based on data for the meadow vole). Both acute and chronic
dietary risk quotients, are presented.
Table 32: Maximum and minimum EECs and acute and chronic risk quotients for meadow vole
exposure to dicofol.
Crop
Apple
Beans
Beans(CA)
Citrus.
Cotton
Cucurbits
Grapes
Hops
Lawn/Turf
Mint
Nuts
Ornamentals
fears
Peppers
Quince
Rate
(Ib at/A)
3
0.5
1.5
3
1.5
0.625
1.165
1.165
0.4
1.25
4
0.4
3
u 0.75
. ' -3 "
LC50 NOEC,
.(ppm)' ''(ppm)1-
1005
1005
1005
1005
1005
1005
1005
1005
1005
1005 .
1005 . .
1005
1005
1005
1005
,25
25
25
25
25
25
25
25
25
25
25
25
25
25
25
Max.
EEC ,
(ppm)3
720
120
360
720
360
150 ,
279.6
279.6
96
300
960
96
720
180
* 720
Min.
EEC
(ppm)4
21
3'.5
10.5
21
10.5
4,375
8:155
8.155
2.8
8.75
28
2.8
21
5.25
21
Max. Min. Acute Max. Chronic
Acute RQ RQ
RQ EEC/ ! EEC/
EEC/ LC50- NOEC,
LC50 ' .
'0.72
0.12
0.36
. .72.
0.36
0.15
0.28
' 0.28
0.10
0.30
0.96
0.10
' 0.72
0.18
0.72
0.02
0.00
0.01 -
0.02
0.01
" 0.00
0.01
0.01
0.00
0.01
0.03
0.00
0.02
0.01
0.02
28.80
' 4.80
14.40
28.80
14.40
6.00
11.18
11.18
3.84
12.00
38.40
3.84
28.80
7.20;
28.80
Min. Chronic
RQ
EEC/ '
NOEC
0.84
. 0.14
0.42
.84
0.42
0.18
0.33
,0.33
0.11
0.35
1.12
6.11
0.84
0.21
0.84
97
-------
Table 32: Maximum and minimum EECs and acute and chronic risk quotients
exposure to dicofol.
Crop
Strawberries
Tomatoes
Rate
(Ibai/A)
0.8
0.75
LCSO
(ppm)'
1005
1005
NOEC
(ppm)3
25
25
Max.
EEC
(ppm)3
192
180
Min.
EEC
(ppm)4
5.6
5.25
Max.
Acute
RQ
EEC/,
LCSO
Or19
0.18
Min. Acute
RQ
EEC/
,,LCSQ
o.oi
0.01
for meadow vole
Max. Chronic
RQ
EEC/
NOEC ; ,
7.68
7.20
Min, Chronic '
RQ
EEC/ , .
NQEC, , :,
0.22
0.21
1 Based on rat LD50 value adjusted for the body weight and food consumption for the meadow vole (MRID
40731202).
2 Based on rat NOAEg of 25 ppm.
3 Maximum EECs on avian food items based on Fletcher et al (1994) for short grass. See Table 15
4 Minimum EECs on avian food items based on Fletcher et al (1994) for fruits and seeds, See table 15.
;_;- , 7J.'.'',',' ". '";,, *",'. ."",'."'.., (a) Acute Mammalian Risk
Maximum risk quotients ranged from 6.10 for the lawn and turf use to 0.96 for use on nut trees.
No minimum risk quotients exceeded 0.12. The use of dicofol at maximum application rates on citrus,
apples, nuts, pears, and quince exceeded the acute high risk LOG of 0.5 for non-target mammalian
species.
In general, acute risk in the form of direct mortality to non-target mammalian species from
exposure to dicofol exceeds the LOG for citrus, apples, pears, nuts, and quince, and then only from
exposure from short grass. Because numerous small mammal species primarily feed on short grass,
acute hazard from these use patterns is possible.
i i (b) Chronic Mammalian Risk
Chronic risk quotients in Table 32 were determined by establishing a ratio between the
maximum and minimum EECs and the lowest effect level (LOAEL) as determined in the mammalian
reproductive tests (in this case, 25 ppm for trie rat). Maximum risk quotients ranged from 3.84 for
lawn, turf, andI ornamentaluses,to 38.4[for use on nut trees. Minimum risk quotients ranged from
0.11 for lawn, turf and ornamentals, to 1.12 for nut trees.
Based upon risk quotients derived from laboratory data and the EEC of dicofol, chronic hazard
(in the form of reproductive impairment) to mammalian species exceeds the LOG for all currently
registered use patterns. There are no mammalian field study data available for reproductive effects.
b. Exposure and Risk to Nontarget Freshwater and Marine Aquatic
Animals
_. , ,, . . | | ,:::;:;, | | |;|. , . . ...p|. /. _ , , j '..>, ' | .. .. , .' -,:,,, ..i;1.. .;':.,.../. ' ,.pi. , ' ../.; \ .PI:I P;IIP
Based on laboratory data, dicofol is characterized as very highly toxic to both cold and warm
water fish species, aquatic invertebrates, and marine and estuarine organisms. As such, the Agency
98
-------
is concerned about any direct and/or indirect contamination of both fresh and salt water environments
from the use of dicofol. Because all current dicofol labels allow for aerial application of dicofol to
many crops that are in close proximity to various types of aquatic environments, the Agency believes
it is reasonable to assume that some direct contamination of aquatic environments is possible from
the use of dicofol. . '''-*,
i. Aquatic Acute Risk From Direct Contamination to Water
Table 33 shows the maximum acute risk quotients for fresh water fish, aquatic invertebrates,
shellfish, and salt water fish, respectively, resulting from direct contamination of dicofol to water.
Table 33: Acute risk quotients for aquatic organisms from direct contamination of dicofol to a 6 inch layer of water (Based
on DeWitt nomograph).
Crop
Apples ,
Beans (CA) ,
Beans
Citrus
Cotton
Cucurbits
Grapes
Hops
Lawn & Turf
Mint
. Nuts
Ornamentals
Pears
Peppers
Quince
Strawberries
Tomatoes
Applic.
Rate (Ib
3.6
1.5
,6.5
3.0
1.5
: 0.625
1.165
1.165
0.4
1.250
4.0
0.45
3.0
0.75
3.0
2.4
0.75
EEC
(ppm)
(6" layer)
2.20
1.10
0.36
2.20
1.10
0.47
0.85
0.85
' 0.29
0.91
2.94
0.33
2.20
0:55
2.20 '
1.76
0.55
Fresh -water Fish1
LC50
(ppm)
0:124
0.124
0.124
0.124
0.124,
0.124
0.124
0.124
0,124
0.124
0.124
0.124
0.124
0.124
0.124
0.124
0.124
RQ
17.7
8.9
2.9
17.7
8.9
3.8
6.9
6.9
" 2.3
. 7.3
23.7
2.7 -
17.7
4.4
17.7
14.2
4.4
Invertebrates2
LC50
(ppm)
0.14
0.14
0.14*
0.14
0.14
0.14
0.14
0.14
0,14
0.14
0.14
0.14
0.14
0.14
0.14
0.14
0.14
RQ
15
7
2'
15
7 .
3
6
6
2
6
21
2
15
3
15
12
3
; Shellfish3 .,
LC50
(ppm)
0:015
0.015
0.015
0,015
0.015 .
0.015
0.015
0.015
0.015
0.015
0.015
0.015
0.015
0.015
0.015
0.015
0.015
RQ
146
73
24
146
73
31
56
56
19
60
196
22'
146
36
146
117
36
Salt water Fish1
LC50
(ppm) '
0.37
0.37
0.37
0.37
0.37
0.37
0.37
0.37,
0:37
0.37
;0.37
0.37
0.37
0.37
0.37
0.37
0.37
RQ "
5.9
3.0
, 1.0
5.9
3.0
1.3
2.3
2.3
0.8
. 2.5
7.9 :
0.9
5,9
.. 1.5
5.9.
4.8 -.
1.5
1 LC50 for freshwater fish is based on rainbow trout.
2 LC50 for invertebrates is based on Daphnia magna.
3 LC50 for shellfish is based on eastern oyster.
4 LC50 for salt water fish is based on sheepshead minnow.
99
-------
Maximum risk quotients for aquatic organisms from the direct contamination of dicofol to a 6"
layer of water were greatest on nut tree uses and lowest for lawn and turf uses. Risk quotients ranged
from 23.7 to 2,3 for freshwater fish, 21 to 2.1 for aquatic invertebrates, 196 to 19.3 for shellfish, and
7.9 to 0.8 for salt water fish.
, i
For fresh water fish, aquatic invertebrates and shellfish, all of the risk quotients exceed the LOG
for acute risk. The only risk quotient that does riot exceed the LOG is for salt water fish for the lawn,
turf, and ornamental use patterns.
ii. Aquatic Acute Risk From Indirect Contamination to Water
(Runoff/Drift)
Table 34 shows maximum acute risk quotients for fresh water fish, aquatic invertebrates,
shellfish, and salt water fish, respectively, resulting from indirect contamination of dicofol to water
by spray drift during application and runoff after the pesticide has been applied. EECs are estimated
using GENEEC (see the Aquatic Exposure Assessment of the Exposure Characterization).
iiii i n < IN 11 i
Table 34: Acute risk quotients for aquatic organisms from indirect contamination of dicofol to a pond via spray drift and
runoff (using peak EECs estimated using GENEEC).
Crop
Apples
Beans
Beans (CA)
Citrus
Cotton
Cucurbits
Grapes
Hops
Lawn & Turf
Mint
Nuts
Ornamentals
Pears
Peppers
Quince
Applfc.
"' "':'':Rate"(lb
a.UA)
I"o
6Ts
1.5
3.0
"I?..'
0.625
1.165
1.165
0.4
, ,' ii i iii ""i ,,
1.250
, ^ .^iiiiiiiiiiij ,,j, ,,
.'.'. '??
MS
3.0
0.75
3'7o
peak Fresh -water Fish'
(ppb)
155
25.9
77.6
155
17.6
38.8
60.3
60.3
20.7
64.7
20:6 "
20.6
155
38.9
155
LC50
: (ppb)
124
""""^124"
124
124
124
124
124
124
124 '
124
124
124
124
124
124
RQ
1.25
0.21
0.63
1.25
0.63
.0.3i
0.49
0.49
0.17
0.52
1.66
0.17
'l.25""
0.31
1.25
Invertebrates*
LC50
(ppb)
140
140
140
140
140
140
140
140
- 140
140
' ; , ,' "!' ' ' ' '-,
140
140
';; wo ;
140
140
RQ
1.11
0.18
0.55
1.11
0.55
0.28
0.43
0.43
0.15
0.46
1.47
0.15
1.11
' 0.28
1.11
Shellfish3
LC50
(ppb)
" 15.1
15.1
15.1
15.1
'l!M
15.1
15.1
15.1
15.1
1 , inili ',!' Ill"1' ' "'
15.1
'."ii;:,1,.":1 '
is.i
1.5.1
15.1
15.1
15,1
RQ
10.3
1.71
5.14
10.3
5-14
2.57 '
3^99 ,
3.99
1.37
4.28
,' y v ,,';' ||;,'
13.6
1.36
1.0.3
2.58
10.3
Salt water Fish*
LC50
(ppb)
370"
370 '
370
370
370
370
370
370
370
370
',' ; ' ," ,/
"'370'
370
370
370
370
RQ '""
"" 0.42
" 6.07 : ,"
0.21
0.42
0.2l" ', , ',""',"
o.io
0.16
0.16
0.06
0.17
|l, ,i, | J, ,,;,, '!'%,, iMJii'i (, lapii, , ,,:;j ',,!,;,,
0.56 '"""""" l; ^
0.06
0.42
0.11
"0.42 '
100
-------
Crop
Strawberries
Tomatoes
Applic. peak
Rate (Ib EEC
a.i./A) (ppb)
2.4 41.4
0.75 38.8
Fresh \vater Fish1
LCSO
(ppb)
124
124
RQ
0.33
0.31
Invertebrates2
LC50-
(ppb)
140
140
RQ
0.30
0.28
, - Shellfish3
LCSO
(ppb)
-.- 15.1
15.1
RQ
2.74
2.57
.Salt water Fish''
LCSO
(Ppb)
370
370
RQ
0.11
r 0.10
1 LCSO for freshwater fish is based on rainbow trout.
2 LCSO for invertebrates is based on Daphnia magna. ' ,
3 LCSO for shellfish is based on eastern oyster. .
4 LCSO for salt water fish is based on sheepshead minnow.
Maximum risk quotients from indirect contamination of aquatic habitats by drift and run-off
were greatest for nut tree use and lowest for lawn and turf uses. Risk quotients ranged from 1.66 to
0.17 for freshwater fish, 1.47 to 0.15 for aquatic invertebrates, 13.6 to 1.36 for shellfish, and 0.56
to 0.06 for salt water fish. . . ,
. For freshwater fish and aquatic invertebrates, application rates equal to or greaterthan 1.25 Ibs.
a.i./A exceed the LOG. All application rates exceed the LOG for shellfish, while only the application
rate of 4 Ibs. ai./acre for nut trees exceeds the LOG for salt water fish species.
Hi. Aquatic Chronic Risk to Fish
Table 35 shows the risk quotients for fresh water fish from chronic exposure to dicofol. The
maximum risk quotient is 0.33 for use on nut trees while the lowest is 0.03 for beans (California),
lawn, turf, and ornamental uses. No use patterns exceed the chronic LOG (1.0) for fish.
Table 35: Risk quotients for fish from chronic exposure to dicofol using GENEEC-derived EECs.
'Crop
Apples
Beans
Beans (CA)
Citrus
' Cotton
Cucurbits
Grapes
Hops
Lawn & Turf
Mint
Applic. Rate 56-day EEC LOAEC1 (ppb)
(lba.i./A) (ppb)
3.0
0.5
1.5
3.0
. 1.5
0.625
1.165 .
1.165
0.4 '
-1.25
1.1
. : 0.5
0.2
1.1
0.7
0.2
0.4
0.5
0.1
0.2
5.5 .
5.5
5.5
, 5.5
5.5
5.5
5.5
5.5
5.5 .
5.5
MOX.RQ
EEC/LOAEC
0.20
0.10
0.03
0.2.0
0.12
0.04
1 0.08
0.09
0.03
0.04
101
-------
Crop
Nuts
Ornamentals
Pears
Peppers
Quince
Strawberries
Tomatoes
Applic. Rate
fib a.iJA)
, , , 4.0
0,45
3.0
0.75
'"' 3.0 '
2.4
0.75
56-day EEC LOAEC1 (ppb) Max. RQ
(ppb) EEC/LOAEC
1.8
0.2
1.-1
0.3
1.1
0.9
0.3
.. , . . 5.5
5.5
, 5.5
5.5
:5.5
5.5
5.5
0.33
0,03
0.20
0,05
0.20
0.16
0.05
1 LOAEC for fathead minnow life-cycle study (MRID 42628901; 43162001).
c. Exposure and risk to Endangered Species
The endangered species level of concern from the use of dicofol is exceeded for fish and aquatic
invertebrates at all label application rates; for birds at application rates greater than 0.75 Ib a.i./acre,
and for mammals at application rates greater than 0.4 Ib a.i./acre. The Endangered Species Protection
Program is expected to become final in the future. Limitations in the use of dicofol will be required
to protect endangered and threatened species, but these limitations have not been defined and may
be formulation specific. The Agency anticipates that a consultation with the Fish and Wildlife Service
will be conducted in accordance wth the species-based priority approach described in the Program.
After completion of consultation, registrants will be informed 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.
i in i i in i i
4. Risk Characterization
1 ' i I I I I II
Available field data suggest that dicofol does not pose significant adverse effects on avian
reproduction and does not present an unreasonable risk to ecosystems. However, the potential for
such effects, based on laboratory data, is great for certain species. Because of uncertainties
surrjpiiding me relationship between the laboratory and field data, the Agency believes it is prudent
to impose risk reduction measures to reduce the likelihood of unacceptable risk as much as possible.
Mitigation and labeling measures presented in chapter 4 should be put in place.
Kjlti , ป|, ' , I'!"1 ;;, w ' i1;1 'mi i iiill'pr ,"!!' ""i i, j, '' ! J! , , I;11-!1 ' J1 ,t " ,' - , ' n,,,*1 |",,|, ,'" ,,:,,, y ' ', : ,; us MI,, ir/i. ' iii'uiJAi' i'. \ ',$ ,r; ;.ป , ' i',1, ' ' ,i '(,' ! .' I
|j.lDataGaps:
I**!1, ',.';,>j'"i. !';,' ; ''I'K'i;! " '',,' '",' '"' "I,"1"; .' " ; ' -I" ', [' -'i''''';'. , I-1,' '','', '' ,;',' '' .K*V' ' "i"!': ' " !: i''| "',:' "
The environmental fate and transport database for dicofol is largely complete. The ecological
toxicity data base is adequate to assess the hazard of dicofol to nontarget terrestrial organisms.
Il'i,; .it '.T'I"'ฐ'' !!,! . , 'I")!!! .I'i,,,*. >,", ."jr.1!, ; >. t , . .. '. "V, i:;: ,,!! ,'-r,; ,,;,':,.'. ::l11 ::: i CVifJ ll'v? IS1",1!;:,. , . Si.' i >''.": >. *.''' :'VS '," ::",. :', "I" '< "' J*"':'
a. Environmental Fate and Exposure Assessment
JDicoM sjiprt to intermediate half-life (days to months) in laboratory studies. The
chemical is likely to be more persistent in acidic than neutral or alkaline soils or waters and in drier
102
IITBll " ',-,: , " ปป ""'" ',j! ' '',!',', ! ,,"i ' ' " ,! ll'"1 '; ,',.,ป J ,, i;, ,' i ' '. ": 'i ',,;, ,,"ซ! ' .'mfr ', i, , ,, .J1, '.',;,:' -: ' ",'! ' ' ,,,,,'', ' ., ri," ',."!/''"i '" |!|,i ''.'IIW 'Vl! i';,:ili if
.ilt'lli .::[.i. i ', i still i*; ' -,,,. '; i.-ii, i ' t'twr ,;; . if :t ,'; " ,: *' : ; : -. ;, /i ,"'t; .,. .; . ,, j.. .. ,; ?(. . ," (I, "I r .: . 1,1 i.f, ,,r !i[/ ' ,';'.,, , .i.c , :,... r ill t':ik If" ......
I'liii?" j .isiii;, ns'aiii ,,; -I , iillii JiJEi!,:1 :',iO.ifl' itlRr -{..^m^,;".;,, i';v ^'lii-ii'iiiJ!11 iliirii V- ':> j'.:l"A,^;ii,i\. L1 SS iksl l''ป:?Xi (Ji'1:1*' ifti'JA'iki' i AK^k- "i:k',KL . U*';'!!, ^WilSiii'lii Miif WM} i(
-------
conditions. Major dissipation routes are hydrolysis under neutral and alkaline pHs and aerobic and
anaerobic soil metabolism, with the p,p'-isomer being more persistent. Laboratory and field data
suggest .that dicofol is not very mobile, and neither leaching nor volatility are expected to play an
important role in the dissipation of dicofol. Terrestrial field dissipation studies conducted in
California suggest that the persistence of dicofol is highly dependent on field and environmental
conditions. Metabolism appears to be the dominant mode of dissipation in the field, -with dissipation
half-lives for the dominant p,p'-isomer ranging from a less than a week to greater than two months.
The more rapid dissipation was associated with greater inputs of water by irrigation.
In a three-year monitoring study, the dissipation half-life for dicofol in soil was on the order of
two months in California and four months in Florida. Dicofol concentrations in soil in New York
remained at a similar level throughout the study period. Factors such as differing pHs of soil and
water (both tend to be in the neutral to alkaline range in California and in the acidic range in New
York, although no field data was provided to assess this), timing and amount of rainfall and irrigation,
and different agronomic practices (including liming) are likely to .influence the persistence of dicofol
in the environment. . '
1 ' . . -\
Major degradates of dicofol are the o,p'- and p,p'- isomers of diclorobenzophenone (DCBP),
chlorobenzoic acid (CBA), I,l-(chlorophenyl)-2,2-dichloroethanol (FW-152), hydroxy-DCPB, and
dichlqrobenzhydrol (DCBH). DCBP is a degradate in hydrolysis, photolysis, and metabolism, while
the-other compounds result from metabolic processes.
Ground Water Assessment '
Dicofol is not expected to leach extensively to ground iwater under label use conditions.
Available data demonstrate low solubility in water, relatively high binding capacity to soils (Kds of
8.4 to 82.8), and little or no movement of the parent compound. While mobility data for dicofol
degradates are not available, no movement of the major degradates was observed in the field studies.
No detections of dicofol in ground water are reported in the EPA Pesticides in Ground Water Data
Base.
Surface Water Assessment
1 Dicofol can contaminate surface water via spray drift during application. Substantial fractions
of applied dicofol could be available for runoff for several days to weeks after application. Because
of susceptibility to hydrolysis with increasing pH, dicofol is not likely to persist in neutral to alkaline
waters, even with long hydrologic residence times. Dicofol may be substantially more persistent in
some acidic waters, particularly in those with relatively long hydrological residence times and low
microbiological populations. -
103
-------
b. Environmental Hazard Assessment
Toxicitv to Terrestrial Organisms:
IP i i 11 ii ill i in i i n ,i ," i v in i i
Dicofol is moderately to slightly toxic on an acute basis to. terrestrial animals and slightly toxic
to honey bees. For avian species, the results of the laboratory studies suggest that the reproductive
sensitivity of avian species to dicofol varies greatly. Raptors appear to be the most sensitive and non-
raptors the least. For example, NOAEC (No Observed Adverse Effect Concentration) values for five
avian species ranged from 1 ppm for the American kestrel to 120 ppm for the Northern bobwhite.
quail. LOAEC (Lowest Observed Adverse Effect Concentration) values ranged from 3 ppm for the
American kestrel to > 120 ppm for the bobwhite quail. The reproductive parameters affected included
egg-shell thickness, shell strength, egg production, and hatchability.
i , " ,'!" I
Using the rat as a surrogate for terrestrial mammals, the NOAEL for reproductive effects is 5
ppm and the J^Q'AEL is 25 ppm. Reproductive effects included reduced viability of pups, increased
number of stillborns, pup death, total litter loss, weight reduction, and vacuolation in ovaries.
Toxicitv to Aquatic Organisms
Dicpfol is highly to very highly toxic to all aquatic organisms tested, including fish,
invertebrates, and estuarine/marine organisms.
Dicofol is highly toxic on an acute basis to both cold and warm water species of fish. It also
causes early life stage toxicity at levels of 19 ppb for fathead minnow and 1 ppb for rainbow trout.
Dicofol is highly toxic on an acute basis to the freshwater invertebrate species, Daphnia magna, with
an ECM of 0.14 mg/1. Dicofol is classified as highly to very highly toxic to marine and estuarine
organisms.
c. Environmental Risk Assessment
Risk to Terrestrial Organisms:
Acute risk, in the form of direct mortality, to non-target mammalian species from exposure to
dicofol exceed the level of concern (LOG) for citrus, apples, pears, nuts, and quince only from
exposure from short grass. Because numerous small mammal species primarily feed on short grass,
acute hazard from these use patterns is possible. For avian species, the acute LOG is exceeded only
in exposure to short grass. Except for the few avian species, such as geese or ducks, which may feed
primarily on short grass, the acute hazard from this use does not present an unacceptable risk.
Maximum and minimum chronic Risk Quotient (RQs) values exceed the LOCs for both
mammalian and avian species for all registered uses of dicofol. Chronic hazard, in the form of
reproductive impairment to mammalian and avian species, can occur for all currently registered use
patterns. The highest exposure is predicted to occur on nut trees and the lowest on lawn and turf.
104
-------
Uncertainties in the modeled terrestrial EECs used to calculate the RQs result from a lack of
data on interception and subsequent dissipation from foliar surfaces. A comparison of the EECs with
levels,measured in the three year, three state monitoring study show that concentrations predicted by
the model are two to ten times greater than levels measured in the crop areas (Table 36). The non-
crop areas had substantially less residue than the crop areas.
Table 36. Comparison of three-year average geometric mean residue values of p,p'-dicofol with EEC values
estimated using the method by Fletcher et al (1994).
State
California
H
Fla.
"
New York
"
Site (Crop)
C (Cotton)
NC .
C (Citrus)
NC
C (Apples)
NC
Foliage EEC Foliage 'Grass EEC
(ppm) Measured (ppm) (ppm)
203 .92 165-360
,0.6
1
1080' '74 . 880-1920
.5.9 ' , ' : '
405 , . 97 - 330-720
5.2
Grass Measured
(ppm)
NG
0.5
78 -
'9.7
48
5.2
C= crop area; NC= non-crop area
NG= Not collected, because no grass present on treated area
r Residues of dicofol were found in terrestrial species in each of the locations, both crop and non-
crop areas, for each of the study years in the field monitoring study. For mammals, dicofol levels
ranged from 2.6 ppm in Florida to 0.6 ppm in New York and California. For terrestrial invertebrates,
dicofol levels ranged from 4.2 ppm in Florida to 1.3 ppm in New York.' Dicofol levels found in
reptiles and amphibians in Florida ranged from 0.02 ppm to 6.6 ppm. In all cases, levels of DDE (a
primary degradate of DDT, known to cause reproductive effects in a number of species) found in the
terrestrial species were one to two orders of magnitude lower than those for dicofol.
Comparisons between estimated environmental concentrations (EECs) and laboratory data
suggest that, for certain avian species, numerous reproductive parameters may be adversely affected
by exposure to dicofol. However, under conditions present in the field studies, adverse avian
reproductive effects in the form of egg-shell thinning were not detected. But it should be noted that
detectable levels of dicofol were found in the birds in all states, but levels of DDE were either equal
to or greater than levels of dicofol.
Risk to Aquatic Organisms: ,
All current dicofol labels allow for aerial application. Many of the crops on which dicofol is
registered for use may be grown in close proximity to aquatic habitats or in areas in which runoff to
water bodies may occur. Therefore, the potential exists for risk to aquatic organisms from exposure -
to dicofol through direct contamination or indirect contamination by spray drift or runoff. For direct
contamination, all RQs exceed the LOG for fresh and salt water fish, invertebrates, and shellfish. For
indirect contamination (i.,e., runoff or spray drift) all application rates exceeded the LOG for shellfish.
105
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II 1 ll H I
For fresh water fish and aquatic invertebrates, application rates equal to or greater than 1.25 Ib a.i./A
exceeded the LOG; for salt water fish, application rates equal to or greater than 4 Ib a.i./A exceeded
the LOG, None of the use patterns exceed the LOG for chronic risk to fish.
EECs used to calculate RQs are upper-bound estimates based on hydrolysis, photolysis, and
mejabolisrn injieutral water. Dicofol is likely to be more persistent in acidic waters and less persistent
in alkaline waters,. In the monitoring studies, geometric mean residue levels of p,p'-dicofol in water
adjacent to the treated areas ranged from 1.5 ppb in Florida to 0.4 ppb in New York. While the
model overestimates peak environmental concentrations for acute effects, it correctly predicts
concentrations below a chronic concern. However, the studies did not provide sufficient information
to determine whether reported residue concentrations reflect typical conditions. Such an evaluation
would need information on water chemistry, particularly pH (the fate of dicofol is pH-dependent),
flow rates, residence time in water, type and location of the receiving water, application and sampling
dates, and the duration and timing of rainfall events.
Peak concentrations of dicofol residue in fish in the monitoring studies ranged from 0.3 - 0.6
ppm in Florida and New York to 0.1 ppm in California. The lowest levels were in the 0.01 ppm range
in all states. In contrast to terrestrial mammals and invertebrates, DDE levels in fish were
approximately equal to or greater than the dicofol levels.
i
Laboratory studies show that dicofol has some potential to bioaccumulate in fish, with
bioaccumulation factors in bluegill sunfish of 6,600,17,000, and 10,OOOX in fillet, viscera, and whole
fish, respectively, during the 28-day exposure period. However, dicofol residues depurated relatively
quickly, with an estimated elimination half-life of 33 days.
i , ' . \
i , i
d. Comparison of Dicofol to DDT and DDE
DicqfoJand DDT are similar in chemical structure. However, important differences in
chemistry separate these two organpchlprine pesticides, picpfpl has an environmentally significant
waฃe-r soi^jjjtjjr -r^;^: ^c^j ^:^ not Dicofol has an
environmental half-life^of'; weeks Compared to years for DDT. While dicpfol has some ability to
accumulate, DDT has a much greater ability to do so. Most importantly, dicofol does not degrade
to DDE, but to degradates less toxic than dicofol, whereas DDT degrades to DDE which ihas been
identified as the toxic moiety.
For dicpfoj, evidence for endocrine disruption is suggestive, but not definitive. It clearly has
reproductive effects in some species, although they appear to differ somewhat from its close
analogues,'" bฃ)T" arid/or '"'DDR Whether "the" difference' is' due' to the" ability'' of dicpfol' to be
metabolize^ tpJess toxic chemicals, its relatively short half-life, or the reduced[potency ofthe parent,
is not known at this time. It is clear, however, that dicpfpl does not present the enormous
bioaccumulation potential of DDT/DDE and, for that reason alone, may be deemed of lesser concern
than DDT/DDE, , ' ,.
106
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e. Inferences from Field Monitoring Studies
Laboratory data suggest dicofol concentrations in excess of 3 ppm will adversely affect
reproductive outcomes in sensitive avian species; levels at or above 25 ppm will similarly affect
mammalian species. Exposure modeling using maximum application rates predict dicofol
concentrations equal to or in excess of these levels. In contrast, the monitoring study indicates that
these models may overestimate exposure concentrations in some instances by several orders of
magnitude. Although the residue monitoring study is handicapped by the limitations previously
discussed, it does provide a "snapshot in time" of environmental levels of dicofol in biotic and abiotic
mediums in three diverse geographical areas and three different crops.
Analysis of monitoring data suggest: .
-limited potential to accumulate in soils;
- detectable residues in fish at levels lower-than DDE residues;
1 - detectable residues in all terrestrial species at levels greater than DDE;
-- - t-
- detectable residues in avian species at levels lower than DDE;
- detectable residues in-eggs, with egg-shell thinning in some species;
- egg-shell thinning is not always correlated with dicofol concentrations.
, It is worthwhile to emphasize that all mediums monitored contained detectable levels of dicofol
in some or all of the samples. Although dicofol was detected in only 50% of the surface water
samples, fish presumably taken from those surface waters did contain detectable levels of dicofol.
For the most part, residue levels exhibited a cyclic patternrising from a background level to a peak
concentration at 7 or 21 days after application and then falling to or near to the previous background
level. Whether these levels are increasing or will increase with time in any of the compartments is not
possible to determine in the context of this monitoring study.
. .. / , .. ,..''
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 dicofol are
eligible for reregistration. The Agency has previously identified and required the submission of
dicofol data required to support reregistration of products containing dicofol. The Agency has
completed its review of these data. Appendix B identifies the generic data requirements that the
Agency reviewed as part of its determination of reregistration eligibility of dicofol, and lists the
submitted studies that the Agency found acceptable.
' ._ 107 ,
-------
Data identified in Appendix B were sufficient for the Agency to assess the registered uses of
dicofol and to deterjpiinejhatJicpfol might be used without resulting in unreasonable adverse effects
to humans and the environment, contingent upon results of dermal tqxicity and Dislodgeable Foliar
Residue (DFR) studiesi that will be> submitted by the registrants (see section B below). Therefore, the
Agency finds that all products containing dicofol as the active ingredient may be eligible for
reregistration, subject to the conditions in this RED, if reyised MOEs, which will be calculated in
consideration of the revised dermal toxicity study, are acceptable (this is further described in Section
B below). The reregistration of particular products is addressed in Section V of this document.
- The Agency will make its reregistration eligibility determination based upon the target data base
required_forirereghtration^ the dermal toxicity study currently being conducted by the registrants,
current guidelines for conducting acceptable studies to generate such data, published scientific
literature, etc., and data identified in Appendix B. Although the Agency has found that all uses of
dtc.ofoj might be eligible for reregistration under currently defined conditions, as defined in this RED,
it should be understood that the Agency may take appropriate regulatory action, and/or require the
submission of additional data to support the registration of products containing dicofol, if new
information comes to the Agency's attention or if the data requirements for registration (or the
guidelines for generating such data) change.
Before Registering products containing dicofol, the Agency is requiring that product specific
data, revised Confidential Statements of Formula (CSF), and reyised labeling be submitted within
eight months of the issuance of this document. These data include product chemistry for each
registration and acute toxicity testing. Additionally, except for cases where the basic registrants have
made commitgients for labej changes in 1999, revised labeling must also be submitted within eight
months of, the issuance of this document. 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. Those products which contain other active ingredients will be eligible for reregistration only
when the other active ingredients are determined to be eligible for reregistratipn.
'"1 "",'
B, Determination of Eligibility Decision
Based pn the,|e,yie,ws^l.theL^eneric^ data for the active ingredient dicofol, the Agency has
sufficient information onthe: health ffffects of dicofol and on its potential for causing adverse effects
in fish and wildlife and the environment. The risk assessment in this RED. raises some strong
concerns forpcjupational dermal exposure. However, the Agency believes thatthe assumptions used
to arrive at this conclusion may have led to an overestimation of risk (i.e. the assumptions of 100%
dermal abspjptipn,a^Dislodgeable Fqliar Residue (DFR) level of 20% at the application rate, and a
residue dissipation rate of 10% per day), To refine our estimation of dicofol risk, the registrants have
initiated a dermal toxicity study, which is due to the Agency on December 31, 1998. In addition, as
a result of a Data Call In from October 13, 1995, the registrants are also completing a DFR study,
duein October, 1998. In order to address the occupational risks identified in this RED while the new
data are being developed and evaluated, the registrants have also agreed to undertake several interim
risk mitigation measures (described in section C of this chapter and Chapter 5). Additionally, the
registrants have agreed to several risk mitigation measures to address ecological and residential risk.
I1'.."lil"! ill I, .1 I,1" i:1
108
[:l r " ill L1;
iii fl 'HiiiiiiiiiiiciJ11 ^,t
-------
The Agency will conclude that dicofol is eligible for reregistration if, after consideration of the
dermal tdxicity data submitted by the registrants, the revised MOEs are found to be acceptable (i.e.,
MOEs above 100). The registrants have submitted a request to voluntarily cancel all uses/products
which are found to have unacceptable MOEs after consideration of the new data and if risks cannot
be mitigated to acceptable levels.
The Agency has determined that dicofol products,' labeled and used as specified in this
Reregistration Eligibility Decision, may not pose unreasonable risks or adverse effects to humans or
the environment, contingent on the results of the dermal toxicity and DFR studies currently being
conducted by the registrants. Under the Food Quality Protection Act of 1996,,the Agency has
determined with a reasonable certainty that no harm will result to infants and children or to the
general population from aggregate exposure to dicofol. The Agency concludes that products
containing dicofol might be eligible for reregistration for all uses, as specified in this RED, contingent
upon results of the dermal toxicity and DFR studies ' * ' .
C. Regulatory Position
As currently calculated in this document, the risk to workers from occupational dermal
exposure exceeds acceptable levels (i.e., current MOEs, are less than 100. See table 11). However,
the Agency believes that the assumption of 1,00% dermal absorption, used in the absence of
acceptable data, may have led to an overestimation of occupational risk. As a result, EPA has found
that it is not appropriate to declare dicofol ineligible at this time. One key consideration's the fact
that the registrants will submit a study by December 31, 1998, which may be a more appropriate
study for regulatory purposes. Although the Agency would not normally delay a decision for a study
voluntarily conducted by registrants outside the RED timeframe, two factors make this appropriate
here. First, the registrants have committed to significant risk mitigation measures to be implemented
immediately. Second,.the registrants have committed to a process that would result in automatic and
voluntary cancellation of any use which continues to have unacceptable risk after EPA completes its
review of the incoming new study, in a timeframe that is comparable or more rapid than what EPA
could achieve through its own regulatory process.
The registrants have agreed to conduct a dermal toxicity study, which will be submitted to the
Agency by December 31, 1998. The registrants will also be submitting DFR data in October 1998.
Results of these studies will be evaluated in conjunction with other toxicity studies arid a decision will
be made on the use of these studies for dermal risk assessment.
' . - - ... - V .,
The registrants has submitted a request to voluntarily cancel all dicofol uses/products that are
found to have unacceptable MOEs after consideration of the new data and if risks cannot be mitigated
to acceptable levels.
To further address risk mitigation during the interim period between the issuance of this RED
and evaluation of the dermal toxicity and DFR studies, the Agency is requiring and the registrants
have agreed to the following: ,
. To address risks to homeowners, residents, and children:
, V 109 '
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All residential uses have been deleted from labels and will be voluntarily canceled.
To address risks to mixers/loaders/applicators:
Mixers/loaders/applicators will be required to wear additional personal protective
equipment (PPEJ, as specified in the labeling specifics in Chapter 5, and use
enclosed cabs and closed cockpits.
i iii 11
k
ป All wettable powder formulations produced after December 31, 1998 must be
produced in water soluble packaging (WSP).
Application with handheld equipment is prohibited for liquid formulations.
All liquid formulations produced after December 31, 1998 must bear labeling
rgquiring; closed mixing systems for dry beans.
To address risks to workers (persons entering treated areas following applications of dicofol):
sine iu M
A revised REI will be set, based on DFR data being submitted in October, 1998,
and on a dermal toxicity study being submitted in December, 1998.
II II IIn I i In ii * , . .ซ i ซ ,
To protect the environment and wildlife:
Dicofol applications are limited to no more than one per year. Previously, for
some uses, the number of applications allowed per year was either unrestricted or
limited to 2 or 3 applications per year.
* Dicofol applications on citrus will not exceed 3 pounds a.iVacre per year. This has
been reduced from 8 pounds a.i./acre per year.
'".,.! Dicofol applications on strawberries will not exceed 2 pounds a.i./acre per year.
This has been reduced from 2.4 pounds a.i./acre per year.
Additionally, as a result of previous agreements with the registrants, applications
will not exceed:
3 Ib ai/acre for apples and pears (reduced from 4 Ib ai/acre);
2 Ib ai/acre for pecans and walnuts (reduced from 4 Ib ai/acre);
1.5 Ib ai/acre; for cotton (reduced from 1.6 Ib ai/acre);
1.3 Ib ai/acre for grapes (reduced from 1.5 Ib ai/acre);
0.63 Ib ai/acre for cucurbits (reduced from 1.5 Ib ai/acre);
0.75 Ib ai/acre for tomatoes and peppers (reduced from .8 Ib ai/acre);
1.5 Ib ai/acre for stonefruits;
1.5 Ib ai/acre for beans; and
0.55 Ib ai/acre for nonresidential lawns and ornamentals.
110
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A spray drift and Runoff Caution Statement is being added to the label. Also, a
"statement prohibiting application directly to water is being added to the label.
1. Tolerance Reassessment
Tolerances for plant commodities should be expressed in terms of the combined residue of 1,2-
bis(4-chlorophenyl)-2,2,2-trichloroethanol and l-(2-chlorophenyl)-l-(4-chlorophenyl)-2,2,2-
trichloroethanol. The listing should be designated 40 CFRง180.163(a).
Tolerances for animal commodities should be expressed as the combined residue of l,l-bis(4-
chlorophenyl)-2,2,2-trichloroethanol, l-(2-chlorophenyI)-l-(4-chlorophenyl)-2,2?2-trichloroethanol,
1, l-bis(4-chlbrophenyl)-2,2-dichloroethanol, and l-(2-chlorophenyl)-l-(4-chlorophenyl)-2,2,-
. dichloroethanol. The listing should be designated 40 CFR ง180.163(b) (Table 38).
2. Tolerance Revocations and Import Tolerances
As part of EPA's reregistration eligibility decision for dicofol, several feed/food uses have been
voluntarily canceled. Once a pesticide use is no longer registered in the United States, the related
pesticide residue tolerance and/or food/feed additive regulation may be no longer needed. It is EPA
policy to propose revocation of a tolerance, and/or food/feed additive regulation, following the
deletion of a related food use from a registration, or following the cancellation of a related food use
regulation. EPA has the responsibility under the Federal Food, Drug, and Cosmetic Act (FFDCA)
to revoke a tolerance/regulation on the grounds that the Agency cannot conclude that the
tolerance/regulation is protective of the public health.
However, the Agency recognizes that interested parties may want to retain a tolerance and/or
food/feed regulation in the absence of a U.S. registration, to allow legal importation of food to the
U.S. To assure that all food marketed in the U.S. is safe, under FFDCA, EPA requires the same;
technical chemistry and toxicology data for such import tolerances (tolerances without related U.S.
registrations) as are required to support U.S. food use registrations and any resulting tolerances. See
40CFR, ง ISSforEPA'sdatarequirementstosupportdomesticuseofapesticideand establishment
and maintenance of a tolerance and/or food/feed regulation. In addition, EPA requires residue
chemistry data (crop field trials) that are representative of growing conditions in exporting countries
in the same manner that EPA requires representative residue chemistry data from different U.S.
regions to support domestic use of the pesticide and the tolerance and/or regulation. Additional
guidance on the Agency's import tolerance policy will be published in an upcoming Federal Register
Notice.
Changes to Tolerances
The raw agricultural commodity tolerances listed under 40 CFR ง180.163 are currently
expressed in terms of dicofol per se. However, the listing of tolerances for residues in/on plant
commodities should be designated 40 CFR ง 180.163(a); as a new section, 40 CFR ง 180.163 (b), must.
be provided for the listing of animal tolerances expressed in terms of the combined residues of dicofol
.and its metabolite FW-152. Refer to Table 38 for modifications in commodity definitions.
Ill ..' ' ' .
-------
In many of the following paragraphs, EPA plans to propose revocation of specific tolerances
r admiius^ratiiye reasons, rather than risk (e.g., creation of group tolerances and elimination of single
*araซrปia\
tolerance).
tolerances Needed Under 40 CFR S180.163(a):
,'' Viป' :i
Sufficient data are to ascertain the adequacy of the established tolerances for the
following commodities: apples, apricots, beans (dry), beans (succulent), bearis (lima), beechnuts,
butternuts, cantaloupes, cherries, chestnuts, cottonseed, crabapple, cucumbers, filberts, grapefruit,
grapes, hazelnuts, hickory nuts, hops, kumquats, lemons, limes, melons, muskmelons, nectarines,
oranges, peaches, pears, pecans, peppermint hay, peppers, pimentos, plums (fresh prunes), pumpkins,
quinces, spearmint hay, strawberries, summer squash, tangerines, tomatoes, walnuts, watermelons,
and winter squash. Sufficient data exist to support the established tolerance for caneberries, but
additional confirmatory data are required, and such will be supplied by IR4.
There is no registered use for dicofol on figs; this tolerance will be proposed for revocation.
The established tolerances for beechnuts, butternuts, chestnuts, filberts, hazelnuts, hickory nuts,
pecans, and walnuts can be lowered from 5 ppm to "6". I ppm, based on nondetectable residues (<6.6l
ppm) in/on pecans and walnuts following registered^use.
The established tolerance for beans, dry, can be reduced from 5 to 6.5 ppm and the tolerance
for beans, succulent, can be reduced from 5 ppm to 3 ppm. Maximum dicofol residues were 0.46
ppm in dry beans and 2.09 ppm in succulent beans following registered use. The established tolerance
for jima beans will be proposed for revocation, as lima beans are covered by the tolerance for beans,
succulent.
Theestablishedtolerancesfor summer squash, cantaloupes, cucumbers, muskmelons, pumpkins
and watermelons can be replaced by a cucurbit group tolerance of 2 ppm. Maximum residues were
1.05 ppm in/on summer squash, 0.45 ppm in/on cucumbers, and 0.3 5 ppm in melons from registered
uses, ,, , ,, , ... ,..., ...... , ,, . ,, ,',, : ..... ,,,,,,, ,,, ,. ,,, , ini [..
* ' ' " t j * n ' ' ,"','''
The registrants have requested a Group 8 (fruiting vegetable.) tolerance, and a value of 2 ppm
would be appropriate (PP 4E4366,2/8/95). This group tolerance would encompass groundcherry,
pepinos and tomatillos. The individual tolerances for tomatoes, peppers, and eggplant will be
proposed for revocation. The maximum residue in/on peppers was 1.15 ppm.. The maximum residue
in/on tomatoes from registered use was 6.46 ppm.
I III I I ,' : llrti'ili , !''. ,1, , '(.!',hi '"'HI:,'i i,,,'1'. in ' i,: i"'<'''!' i I il1 " '," n, '" '" ' M 1,1 I*". ,!, ','', , Mi '.It'1 , , ' , , , ,; r ,'i|,, "" '.!',' ,: , it"!1! J flLlMt
A stone fruit crop group tolerance of 5 ppm will be established, and the individual commodity
tolennces (peach, nectarine, apricot, and plum) should be proposed for revocation. The maximum
residues in/on peaches was 3.79 ppm. The maximum residue in/on plums (fresh prunes) was 0.84
ppm. The maximum residue found in/on cherries was 3.08 ppm.
112
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Established tolerance for oranges, tangerines, limes, and other citrus fruits can be replaced with
a citrus crop.group tolerance of 6 ppm. The maximum residue in/on oranges was 3.55 ppm and the
maximum residue in/on grapefruit was 5.26 ppm. The.maximum field trial for lemons was 1.3.4 ppm.
The established tolerance for apples, crabapple, pears, and quinces can be proposed for
revocation and replaced with a pome fruit crop group tolerance of 10 ppm. The maximum field trial
residue in/on apples was 6.7 ppm. The maximum residue found in/on pears was 10..8 ppm. This
value was one of two duplicate samples. The other sample had a value of 6.8 ppm dicofol. The PHI
was 6 days, whereas the label specifies 7 days, and three applications were made, whereas the label
specifies a maximum of two applications per season. The group tolerance will adequately cover
pears. , '
The currently established tolerance for hops is based on data for green hops. "However, the
Agency now considers the RAC for hops to be hops, dried (PR Notice 93-12, 12/23/93). The
available residue data on driedhops (8.5% moisture) indicate dicofol residue levels of 5.52-64.3 ppm
(CBRS No. 9968, DP Barcode D178940, 9/23/92, F. Fort). Therefore, the tolerance for hops, dried,
as an RAC will be established at 65 ppm.
The established tolerance for strawberries will be raised from 5 ppm to 10 ppm to reflect the
findings of new field trials.
ฃ .
The agency now requires residue data for cotton gin byproducts (commonly called gin trash)
which includes burrs, leaves, stems, lint, immature seeds, sand, and dirt. As these data requirements
are based on the recently issued OPPTS Residue Chemistry Test Guidelines, 860.1000, Table 1, they
are considered confirmatory data and should not impede the reregistration process.
The Agency recommended for establishment of a tolerance of 30 ppm for residues of dicofol
on fresh plucked tea leaves and for 50 ppm for dicofol residues in/on dried tea.
Tolerances needed under 40 CFR SI80.163(V):
The available livestock feeding studies have been evaluated and the data indicate that tolerances
are needed on livestock commodities. The maximum theoretical dietary burdens for cows and beef
cattle, based on the reevaluated tolerances (Table 37), are calculated to be 22 ppm and 41 ppm,
respectively. The theoretical diet is composed of apple pomace, citrus pulp, cottonseed, cottonseed
meal, and cottonseed hulls. Apple pomace is the largest contributor to the exposure (86% of cow
exposure, 93% of beef exposure).
113
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Table 37: ' Maximum Dietary Burden for Cows and Beef Cattle
Commodity
Apples,
pomace, wet
Citrus, pulp,
dried
Cottonseed
Cottonseed,
...meal
Cottonseed,
hulls
Other
III 1 1 i
TOTAL
Reassessed
Dicofol
Tolerance1
(ppm)
38
12
Q.1
5:i '
0.1
"i
%Dry
Matter2
40
91
88
89
90
-
Cow
% in Diet2
20
20
25
15
15
5
100%
Contribution
(ppm)
19
2.6
0.03
0.02
0.02
1 t
22
Beef
% in Diet2
40
.25
25
io'
-
1
100%
Contribution
(ppm)
38
3.3
0.03
0.01
- '
- , /J
41
1 Includes considerations of policy for revised treatment of processing studies and of need for feed tolerances (E.
Zager,. Metzger, 07/17/95 Memorandum). .
2 Table II Update (06/94) and revisions of 09/95.
Recommendations for ruminant commodity tolerances are based on the 10 ppm and 30 ppm
feeding studies (~ 0.5 - 1.4X the maximum theoretical dietary intake for dairy cattle, 0.7X for beef
cattle ). Recommended poultry tolerances are based on data from a 0.5 ppm feeding study (~25X),
adjusted for the difference between actual and theoretical feeding levels. A new section, designated
40 CFR ง180.163(b), must be added to provide listings for the new tolerances required for the
combined residues fifdicofpj and its metabolite FvV-152 in meat, fat, and meat byproducts of cattle,
goats, hogs, horses, sheep, and poultry, milk, and eggs. Sufficient data are available to determine
appropriate tolerance levels for all animal commodities.
* ' " I ' " '" ' ' '" ป"ป" ' 1 ." ". .
Tolerances Listed Under 40 CFR $185.410:
The foocl additive tolerances listed under 40 CFR ง185.410 are currently expressed in terms of
dicofol per se. EPA issued a Final Rule revoking the established food additive tolerance for residues
of dicofol in dried tea (59 FR10993, 3/9/94), to be effective 5/9/94. EPA stayed the effective date
of the final rule (59 FR 23799, 5/9/94), owing to objections filed by the Dicofol Task force and the
.National Agricultural Chemical Association. The Agency recommended revocation of the food
additive tolerance for dried tea (40 CFR ง185.410) and the establishment of tolerances for plucked
tea and dried tea. " s
Additional tolerances needed for processed commodities:
The available data from processing studies indicate that the following tolerances are needed:
114
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1.
ii.
iii.
i'v.
v.
vi.
prunes at 3 ppm, based on the highest average field trial residue of 0.79 ppm for dicofol
on plums and an average concentration factor of 3.IX;
raisins at 20 ppm, based on the highest average field trial residue of 3.02 ppm on grapes
and an average processing factor of 6.6X;
citrus oil at 200 ppm, based on the highest average field trial residue of 3.16 ppm in
oranges, and average processing factor of 62.8X for orange oil; ' , ".
dried tea leaves at 50 ppm, based on the highest average field trial residue of 29.1 ppm,
an average processing factor of 1.6X; .
peppermint oil and spearmint oil at 30 ppm, based on the highest average field trial
residue of 17.6 ppm and an average processing factor of 1.6X; and cottonseed oil; and
cottonseed oil at 0.5 ppm, based on the concentration factor of 4.9X and the highest
average field trial residue of 0.06 ppm.
Sufficient data are available, to determine that the following feed tolerances are needed:
i. apple pomace (wet) at 38 ppm, based on the highest average field trial residue of 5.54
ppm.ahd an average concentration factor of-6.6X in wet pomace; and
ii. citrus pulp (dried) at 12 ppm, based on the highest average field trial residue of 3.16 ppm
(orange) and an average concentration factor of 3.7X.
Table 38: Tolerance Reassessment Summary for Dicofol
Commodity
Current Tolerance
; (ppm)
Tolerance
Reassessment (ppm)
Comment/Correct ,
Commodity/Definition
Tplerances Listed Under 40 CFR ง180.163 a
Apples
Apricots
Beans (diy form)
Beans, snap (succulent
form)
Beans, lima (succulent
form)
Blackberries
Boysenberries
Beechnuts
Butternuts
Cantaloupe
5
" 10
5
.5
5
5
5 ,
5
5
5
Propose Revocation
Propose Revocation
0.5
3
Propose Revocation
Propose Revocation
Propose Revocation
0.1
0.1, .
Propose Revocation
Replace with pome fruit tolerance
(10 ppm.). New field trials0.
Replace with stone fruit tolerance
(5 ppm.). See peach0.
Beans, dry. New field trials0.
Beans, succulent. New field
trials0.
Covered by tolerance for beans,
succulent0.
Additional data required. Replace
with caneberry tolerance (5 ppm.).
Additional data required. Replace
with caneberry tolerance (5 ppm).
See pecan/walnut0.
See pecan/walnut0.
New field trials0. Replace with
cucurbit tolerance (2 ppm).
115
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Commodity
Caneberry
Cherries
Chestnuts
Citrus fruits
Cottonseed
Cotton Gin Byproducts
Crabapple
Cucumbers
Cucurbit Vegetables
Dewberries
Eggplants
Figs
Filberts/Hazelnuts
Fruiting Vegetables
Group
Grapefruit
Grapes
Hickory nuts
Hops, dried
Kumquats
Lemons
Limes
Loganberries
Melons
Muskmelons
Nectarines
Current Tolerance
(ppm)
none
5
5
None
0.1
None
5
5
None
5
5
5
5
None
10
5
5
30
10
10
10
5
5
5
10
Tolerance
Reassessment (ppm)
5
Propose Revocation
0.1
6
0.1
TBDb
Propose Revocation
Propose Revocation
2
Propose Revocation
Propose Revocation
Propose Revocation
0.1
2
Propose Revocation
. 5
0.1
65
Propose Revocation
Propose Revocation
Propose Revocation
Propose Revocation
Propose Revocation
Propose Revocation
Propose Revocation
Comment/Correct
Commodity/Definition
Crop group tolerance. Additional
field trials required.
New field trials0. Replace with
stone fruit tolerance (5 ppm).
See pecan/walnut0.
Crop group tolerance.
Cotton, seed
OPPTS Guidelines 860; Table I
See apple0. Replace with pome
fruit tolerance (10 ppm).
New field trials0. Replace with
cucurbit tolerance (2 ppm).
Crop group tolerance.
Additional data required. Replace
with caneberry tolerance (5 ppm.).
Replace with fruiting vegetables
tolerance (2 ppm)ฐ.
No registered use exists0.
See pecan/walnut0.
Crop group tolerance0.
New field trials0. Replace with
citrus tolerance (6 ppm).
See pecan/walnut.
Hops, dried. RAC redefined0.
See orange0. Replace with citrus
tolerance (6 ppm).
New field trials0. Replace with
citrus tolerance (6 ppm.).
New field trials0. Replace with
citrus tolerance (6 ppm).
Additional data required. Replace
with caneberry tolerance (5 ppm).
New field trials (cantaloupes,
muskmelon)0. Replace with
cucurbit tolerance (2 ppm).
New field trials0. Replace with
cucurbit tolerance (2 ppm).
See peach0. Replace with stone
fruit tolerance (5 ppm.).
116
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Commodity
Oranges
Peaches
Pears
Pecans
Peppermint, tops
Peppers
Pimentos
Plums (fresh prunes)
Pome fruits
Pumpkins
Quinces
Raspberries
Spearmint, tops
Stone fruits
Strawberries
Summer squash
Tangerines
Tea, plucked leaves
Tomatoes
Walnuts
Watermelons
Winter squash
Cattle, meat
Current Tolerance
(ppm)
10
10
5
5
25
5
5
, 5
None
5
5
.5
25
None
5
5
, 10
None
5
5
,. - 5
5
Tolerance
Reassessment (ppm)
Propose Revocation
Propose Revocation
Propose Revocation
0.1
25
Propose Revocation
Propose Revocation
Propose Revocation
10
Propose Revocation .
Propose Revocation
Propose Revocation
25
-, . 5
10
Propose Revocation
Propose Revocation
30
Propose Revocation
0.1
Propose Revocation
Propose Revocation
Comment/Correct
Commodity/Definition
New field trials0. Replace with
citrus tolerance (6 ppm).
New field trials0. Replace with
stone fruit tolerance (5 ppm.).
New field trials0. Replace with
pome fruit tolerance (10 ppm.).
New field trials0.
Replace with fruiting vegetables
tolerance (2 ppm)c.
Replace with fruiting vegetables
tolerance (2 ppm) ฐ. ,
New field trials0. Replace with
stone fruit tolerance (5 ppm).
Crop group tolerance.
See squash0: Replace with
cucurbit tolerance (2 ppm).
See apple0. Replace with pome
fruit tolerance (10 ppm);
Additional data required. Replace
with caneberry tolerance (5 pom).
Crop group tolerance.
New field trials0.
New field trials0. Replace with
cucurbit tolerance (2 ppm).
See orange0. Replace with citrus
tolerance (6 ppm).
New RAC definition0.
New field trials0. Replace with
fruiting vegetable tolerance (2
ppm).
New field trials0.
See melons0. Replace with
cucurbit tolerance (2 ppm.).
See summer squash, cucumber,
melon0. Replace with cucurbit
tolerance (2 ppm.).
Tolerances Needed Under 40 CFR ง180.163(b)
None
3
Feeding study0. ^ _^
117
-------
,i! W'\W> 't*
'i ii", i'iii; ''"i'ii
ML'1,1,* !!li;4
'"I IB):, ! ',; ", IS.
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""!i|i iFih'i ! .'ilf'l1' ".I !|
Commodity
Cattle, mbyp
(excluding liver and
kidney)
Cattle, kidney
Cattle, liver
Cattle, fat
Eggs
Goats, meat
Goats, mbyp
(excluding liver and
kidney)
Goats, kidney
Goats, liver
Goats, fat
Hogs, meat
Hogs, mbyp (excluding
liver and kidney)
Hogs, kidney
Hogs, liver
Hogs, fat
Horses, meat
Horses, mbyp
(excluding liver and
kidney)
Horses, kidney
Horses, liver
Horses, fat
Milk
Poultry, fat
Poultry, liver
Poultry, mbyp
(excluding liver)
Poultry, meat
Sheep, meat
Current Tolerance
(ppm)
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
Tolerance
Reassessment (ppm)
3
3
5
50
0.05
3
3
3
5
50
3
3
3
5
50
3
3
3
5
50
22
0.1
0.1
0.1
0.1
3
Comment/Correct
Commodity/Definition
Feeding study'.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0, Established at
0.05 for compatibility with Codex
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Reflecting 0.75 ppm in whole
milk corrected by a 30X factor to
account for concentration in milk
fat. Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
Feeding study0.
118
-------
Commodity
Sheep, mbyp
(excluding liver and-
kidney)
Sheep, kidney
Sheep, liver
Sheep, fat
Current Tolerance
(ppm)
None
None
None
None
Tolerance
Reassessment (ppm)
3
3
5 . ,
50
Comment/Correct
Commodity/Definition
Feeding studyc.
Feeding studvc.
Feeding study0.
Feeding study0.
Processed Commodity Tolerances
Apples, pomace, wet
Citrus pulp, dried
Citrus oil
Cottonseed, oil,
refined
Grapes, raisins
Mint oil
Prunes
Tea, dried leaves
. None
None
None
None
None
None
None
45
38
. 12
200,
0.5
20
30
'3
50
Processing study0.
Processing study0.
Processing study0, '
Processing study0.
Processing study0!
Processing study0.
Processing study0.
Processing study0.
a The listing of tolerances for residues in/on plant commodities should be designated 40 CFR .ง 180.163(a), as a
new section, 40 CFR ง180.163(b), must be provided for the listing of animal tolerances expressed in terms, of
the combined residues of dicofol and its metabolite FW-152.
b TBD = To be determined when all data requirements are satisfied. :
0 Reason for tolerance change.
3. Codex Harmonization '
Several maximum residue limits (MRLs) for dicofol have been established by Codex in various
commodities. Codex MRLs and corresponding U.S. tolerances,,both currently .expressed in terms
of dicofol perse, for plant commodities and dicofol plus FW-152 for animal commodities are listed
in Table 39, which follows. . -
The harmonization of Codex MRLs and US tolerances has been updated. The tolerance for
eggs should be lowered to 0.05 ppm for compatibility with Codex.
119
-------
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S
S
Data do not support a lower US tole
trial residues as great as 0.4 ppm.
m
o
--
0
/~\
t
m
tซ%
1
o
1
U.S. tolerance is for stone fruit
m
in
8
o
fi
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53
Data do not support a lower U.S. tol
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m
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o
U.S. tolerance is set at the demonstrated 1
quantitation.
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o
o
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00 ft
U.S. tolerance is for1 the fruiting vegetable
Field trial data for peppers indicate that a
tolerance would riot be adequate.
rs
*"*
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."g
0,
ft
eS
|
&.
U.S. tolerance is for stone fruit Data sup
tolerance for plums per se.
m
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11
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Apple data require a tolerance >5 ppm; m
residue 6.7 ppm. Other pome fruits are a<
covered by a 10 ppm tolerance.
o
n
a
8
1
Compatible
o
1 ~
o
*^
s
1
S
TO
!ซ
s .
Data support a tolerance of 3 ppm, but pn
covered by the stone fruit group tolerance.
in
-
m
1
1
Data indicate that the maximum residue si
exceeded 1 ppm.
-------
The following conclusions can be made regarding efforts to harmonize U.S. tolerances with the
Codex MRLs:
, 'H
Based on the currently registered use pattern, dicofol residues in/on dried hops would exceed
the Codex MRL. The U.S. tolerance cannot be lowered to achieve compatibility.
Compatibility currently exists between the Codex MRL for "Fruits" and some of the applicable
tJ.S. tolerancgi, Hpweyer, based on the currently registered use pattern, dicofol residues would
^^ป ^ (e.g. fruits, pome), and these U.S. tolerances cannot be
lowered to achieve compatibility.
Compatibility exists between the Codex MRL for tea and the proposed US tolerance for dried
tea, 50 ppm.
4. Food Quality Protection Act Findings
i;, .. , , , , aSs Determination of Safety for U.S. Population
EPA has deterrninedi that established tolerances for dicofol with amendments and changes
specified in this document meet the safety standards under FQPA amendments to section
408(b)(2)(D) requiring a reasonable certainty of no harm for the general population. In reaching this
determination, EPA has considered available information on aggregate exposures (both acute and
chronic) from food and drinking water.
The aggregate risk assessment for dicofol concludes that acute dietary exposure to dicofol
residues, including drinking water, does not pose a risk to any population subgroup.
The aggregate risk assessment for dicofol concludes that chronic dietary exposure to dicofol
residues, including drinking water, does not pose a risk to any population subgroup.
Since all residential uses of dicofol are being eliminated, no dermal or inhalation exposure is
expected in or around the home and, therefore, the risk assessment is not required.
b. Determination of Safety for Infants and Children
i . '
EPA has determined that established tolerances for dicofol, with amendments and changes as
specified in this document, meet safety standards under the FQPA amendments to section
408(b)(2)(C) for infants and children and that there is a reasonable certainty of no harm to infants and
children. The safety determination for infants and children considers factors noted above for the
general population but also takes into account the possibility of increased dietary exposure due to the
specific consumption patterns of infants and children, as well as the possibility of increased
susceptibility to the toxic effects of dicofol residues in this population subgroup.
122
ilia iia JIM^^ i ' . '
-------
In determining whether or not infants and children are particularly susceptible to toxic effects
from dicofol residues,. EPA considers the completeness of the database for developmental and
reproductive effects, the nature and severity of the effects observed, and other information:
As noted in Section IE, B-2, the Agency has determined that for dicofol, the 1 OX safety factor
required by FQPA to account for enhanced sensitivity of infants and children can be reduced to 3X.
This reduction is based on data results for dicofol and is explained in Section IH, B-2.
In deciding to continue 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 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.
EPA may determine, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate. In this case., the Agency will take
such action as may be appropriate including, but not limited to, reconsideration of any portion of this
RED. ' -'>.--.'
5. Summary of Risk Management Decisions
a. Human Health
EPA believes that, given the weight of the evidence, dietary risk from dicofol to all US
population subgroups does not exceed the Agency's level of concern (LOG) and is therefore not
cause for concern.
Acute Dietary ,
The acute aggregate risk from food and drinking water through highly refined probabalistic
analysis do not exceed the Agency's LOG. Therefore, no risk reduction or risk mitigation steps are
. necessary. ' .
. Chronic Dietary
Chronic dietary risk from food sources and drinking water is measured at well below the
Agency's LOG. Highest risk population from food exposure are children (1-6 years old), at 38% of
the RfD, based on a DRES chronic exposure analysis. The addition of drinking water exposure to
dicofol is not significant enough to cause concern. Therefore, no risk reduction or risk mitigation
steps are necessary for this route of exposure.
123
-------
ill !ซ" , ; MJ'T 'i I
J 1,1 'Hi IJP i'l"1 ,111' Hi
Occupational and residential
The risk assessment in this RED raises some strong concerns for dicofol mixers/loaders/
applicators, and field workers. The endpoint of concern is hormonal toxicity. At the present time,
most short term and all intermediate term scenarios result in Margin of Exposures (MOEs) which
exceedI the Agency's level of'concern, even with engineering controls. However, the Agency believes
that the default assumptions used to arrive at this conclusion may have led to an overestimation of
that risk (i.e. the default assumption of 100% dermal absorption and a initial Dislodgeable Foliar
Residue (DFR) levelat 20% of the application rate and assuming residue dissipation of 10% per day).
To improve our estimation of dicofol risk, the registrants have initiated a dermal toxicity study, which
is due to the Agencyon December 31, i998. In addition, as a result of a Data Call In from October
13, 1995, the registrants are also completing a DFR study, due in October, 1998. EPA will consider
resultsof^thesejtwdjes in a revised risk assessment. In the interim, whUe this data is being developed
and evaluated, the registrants have agreed to undertake risk mitigation measures (described .below)
to address me occupational risks identified in this RED. .
EPA will revise the Restricted Entry Interval (REI) based upon results of the dermal toxicity
studv and DFR studv.
Because all residential uses are being voluntarily canceled by the registrants, residential risk is
not a concern,
;.;"ji '||; ; ii ,.IH. i i i i 11 in , ..
,i ' , , !';'ll .l'1 I!1" ill" Ml Jl" II I J , ! * .
Endocrine Disrupter Effects
EPA is required to develop a screening program to determine whether certain substances
Includingd\ pesticides and inerts) "may have an effect on humans that is similar to an effect
produced by a naturally occurring estrogen, or such other endocrine effect..." The Agency is
cliiflntly working with interested stakeholders, including other government agencies, public interest
groups, arid industry and research scientists in developing a screening and testing program and a
priority setting scheme to implement this program. Congress has allowed 3 years from the passage
Of |gP A ^August 3,1999) to implement this program. At that time, EPA may require further testing
of t|is active ingredient and end use products for endocrine disrupter effects.
; a , ."If'ป; ;' ' *;'.:-;i il:i '!tป',.';:; * -,;;ซฃ,<'?:$': >'. 'in.; .".;.,:;" i r::;;,,/-';t ,',- ^;1- ^;$:;: ?;,rf'" <:...;:i';. i:, :, ,'':,.; *. .'f;:$\r.fM^iis'
';; , ;,;;:":";'.,; b. ^IVffOP^^tal ,. , . .., ,, , , ,
"i .mi11 ' , ' iiiiii'l.!,1 . ' ' ' ;,,''' J1" i k ''' ,i'' Fiiii'i '' ',"',"!"'""' * i "' i ,i.!'!',ii"iri!!" ซ'i 'ii' " . . "V i ,''.,., i j ',,,'i1 ". , ", '',.. |i''', '' ' ' I'linii' ,i ,"'"' !:. ป','',,' 1:1. /i"i i,;1," ,'ij!'1! r'!1. : i ."a : i.r ;'!''''in iiiw1,1!"
' '' ' ' "
,ii!,; i(i.iJ; ,,; .^the Agency has concluded thatthere are
I.!;:":;;"'' S^IS^lJ&^SirPS^.?^ &SlR^^ii-lH5t,be jddrejsed^throijgh^ risk reduction and/or risk
rhitigation. The fojlpwing risk reduction/risk mitigation measures are being taken to specifically
'* address environmental concerns noted in this
:'i i'':::.ftii ":;.-.ife j1! ' ini I i ซ ' i i \
s:!,!. Applications of dicofol will be limited to no morethan one per year. Previously, in some
uses, thei number of applications allowed^er year was either unrestricted or limited to
two or three applications per year.
Citrus application levels have been reduced^fromSlbs.a.i. peracreto3 Ibs. a.i.peracre.
Further reductions will be made, if required, based on the results of the ongoing dermal
'" ' ' " ' """" " " ' '124 ' ' ' "' ' " ' " ' "
-------
study, within one year of the publication date of this RED. '"
Application rate for wettable powders on strawberries has been reduced to 2 Ibs. a.i. per
acre, reduced from 2.4 Ibs. a.i. per acre. '
A spray drift and Runoff Caution Statement is being added to the label: Also, a
statement .prohibiting application directly to water is being added to the label.
Additionally, as a result of previous agreements with the registrants, applications will not
exceed: .
, 3 Ib. ai/acre for apples and pears (reduced from 4 Ib. ai/acre);
2 Ib. ai/acre for pecans and walnuts (reduced from 4 Ib. ai/acre);
1.5 Ib. ai/acre for cotton (reduced from 1.6 Ib. ai/acre);
, 1.3 Ib. ai/acre for grapes (reduced from 1.5 Ib. ai/acre);
0.63 Ib. ai/acre for cucurbits (reduced from 1:5 Ib. ai/acre);
, 6.75 Ib. al/acre for tomatoes and peppers (reduced from .8 Ib. ai/acre);
1.5 Ib. ai/acre for stonefruits;
1.5 Ib. ai/acre for beans; and '
0.55 Ib. ai/acre for nonresidential lawns and ornamentals..
i. Avian
Acute - . '
Acute risk to avian species is considered low. The only acute avian exposure to dicofol which
exceeds the Agency's level of concern is to short grasses. Since few avian species feed primarily on
short grasses, that risk is not considered unacceptable. Therefore, no risk reduction and/or risk
mitigation measures are necessary.
Chronic *
Laboratory tests have shown dicofol can have adverse reproductive effects on birds, specifically
egg shell thickness, weight, and strength, egg production, and hatchability. Field monitoring found
that, in some instances, the concentrations of dicofol in egg residues exceeded those levels found to
cause reproductive problems in laboratory studies. While actual effects were not demonstrated in the
field monitoring study, the study was designed to measure dicofol concentrations in various
environmental compartments, not to test for effects. Therefore, the agency has concluded that
measures to reduce such potential risk, as detailed above, are warranted. . .
ii. Mammals
Acute
Acute risk to mammals, including threatened and endangered species, from exposure to dicofol,
is considered moderate. These risks exceed the Agency's level of concern for citrus, apples, pears,
nuts, and quince, only from exposure to short grass. To protect various small mammals which
primarily feed on short grass, the Agency recommends application reductions and other risk
mitigation measures detailed above for these use patterns.
125- '.-"'
-------
Chronic
As with avian species, dicofol has been shown to have an effect on mammalian reproductive
physiology and offspring, exceeding the Agency's LOG for all currently registered use patterns. Risk
reduction/mitigation measures ^ ^i Use patterns, as noted at the beginning of this section, are
appropriate to address reproductive concerns.
iiiซ Insects
Dicofol is considered slightly toxic to bees. Recommended risk mitigation steps will address
this.
iv. Freshwater Fish, invertebrates, and estuarine/marine organisms
. . Acute
Dicofol is Vei7 highly toxic to fresh- and salt-water fish, shellfish, and aquatic invertebrates.
These aquatic habitats are potentially at risk from direct contamination of dicofol to water or indirect
contamination via spray drift or runoff. Exposure from indirect or indirect contamination exceeds
several Agency levels of concern. Risk reduction and/or mitigation measures, as listed at the
9f th!s section, are appropriate to address acute risk concerns.
Chronic
use patterns currently registered exceed the Agency's chronic LOG for fish.
Therefore, no risk reduction and/or risk mitigation measures are necessary to reduce chronic risk to
fish.
v. Nontarget Plants
II I I I I I I I I I J I I
Plant testing is not required for pesticides other than herbicides.
i i i > i n i
vi. Surface Water
Dicofol can contaminate surface water via spray drift during application and by runoff for
several days to weeks after application. Once it reaches surface waters, dicofol is not likely to persist
in neutral to alkaline waters, but. may be substantially more persistent in some acidic waters,
particularly in those with relatively long hydrological residence times and low microbiological
populations. Appropriate labeling and other risk mitigation measures to reduce the risk of runoff are
being added to labels, including the labeling statement prohibiting applications directly to water.
These label changes are noted in Chapter 5.
126
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vii. Ground Water
Because dicofol has low to moderate mobility and moderate persistence, it is not expected to
leach extensively to ground water under normal use conditions. Field trials showed no movement of
dicofol degradates/metabolites into ground water. Risk of dicofol contamination in groundwater is
considered low. Therefore, no risk mitigation and/or risk reduction steps are necessary in this area.
6. Occupational Labeling Rationale/Risk Mitigation
At this time, all products containing dicofol are intended solely for occupational use (i.e! mixed,
loaded, and applied by commercial applicators only; not available to homeowners). No registered uses;
will involve applications at residential sites. - . ;
a. The Worker Protection Standard
EPA's Worker Protection Standard for Agricultural Pesticides (WPS) affects all pesticide
.products whose labeling reasonably permits use in the commercial or research production of
agricultural plants on any farm, forest, nursery, or greenhouse. In general, WPS products had to bear
WPS-complying labeling when sold or distributed after April 21, 1994. The WPS labeling
requirements pertaining to personal protective equipment (PPE), restricted-entry intervals (RET), and
notification 'are interim. These requirements are to be reviewed and revised, as .appropriate, during
reregistrati on and other Agency review processes. - - "
, Many uses of dicofol are outside the WPS scope.
b. Requirements for Handlers
For each end-use product, personal protective equipment and engineering control requirements '
for pesticide handlers are set during reregistrati on as follows:
, Based on risks posed to handlers by the active ingredient, EPA may establish
active-ingredient specific (a-i specific) handler requirements for end-use products
containing that active ingredient. If such risks are minimal, EPA may choose not
to establish a-i specific handler requirements.
EPA establishes handler PPE requirements for most end-use products, ba'sed on
each product's acute toxi city characteristics.
If a-i specific requirements have been established, they must be compared to the
! PPE specified for the end-use product. The more stringent choipe for each type of
PPE (i.e., bodywear, hand protection, footwear,, eyewear, etc.) must be placed on
the label of the end-use product. Engineering controls are considered more
stringent than PPE requirements.
127
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EPA is establishing a-i specific requirements for all occupational handlers for dicofol. EPA
calculated that margins of exposure (MOE) were very low and a serious concern for all occupational
mixers, loaders, and applicators. Wettable powder formulations produced after December 31,1998
will be required to be formulated in water-soluble packaging. Applicators using aerial or mechanical
ground equipment will be required to be in enclosed cabs or enclosed cockpits and flaggers for aerial
applications will be required to use enclosed cabs. All other handlers will be required to wear
chemical-resistant gloves, footwear, and headgear (if overhead exposure), double-layer of body
protection, and a respirator. In addition, a chemical-resistant apron will be required for mixers,
loaders, cleaners of equipment, and handlers applying dicofol as a dip. Use patterns and PPE are
specified in Chapter 5. Handheld application equipment is prohibited for liquid formulations.
Application of liquid formulations on dry beans must be done using closed mixing systems.
Since potential handler exposure is similar for WPS and nonWPS uses, the a-i specific handler
requirements (specified in Section V) are the same for WPS and nonWPS occupational uses of
dicofol end-use products.
c. Homeowner Use Products
. ' /1 ' , < ' ' '
Because all residential uses are canceled for dicofol, no homeowner use requirements are
necessary. : .
'I , ' , ' ',,'..'"
d. Post-Application Entry restrictions
Occupational-Use Products (WPS Uses)
" i
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Restricted-entry intervals, early-entry PPE, and "double" notification:
The interim Worker Protection Standard (WPS) restricted-entry intervals (REI's) for
agricultural workers are based solely on the acute dermal toxicity and skin and eye irritation potential
of the active ingredient. In addition, the WPS retains two types of REI's established by the Agency
before the promulgation of the WPS: (1) product-specific REI's established on the basis of adequate
data, and (2) interim REI's that are longer than those that would be established under the WPS.
; V " : . ,
The WPS prohibits routine entry to perform hand labor tasks during the REI and requires PPE
to be worn for other early-entry tasks that require contact with treated surfaces.
"Double" notification is the statement on the labels of some WPS pesticide products requiring
employers to notify workers about pesticide-treated areas orally as well as by posting of the treated
areas. The interim WPS "double" notification requirement is imposed if the active ingredient is
classified as toxicity category I for acute dermal toxicity or skin irritation potential.
During the reregi strati on process, EPA establishes REI's, early-entry PPE, and double
notification requirements based on consideration of all available relevant information about the active
ingredient, including acute toxicity, other adverse effects, epidemiological information, and post-
application data. EPA will establish a restricted-entry interval for dicofol upon completion of analysis
128 -' '
-------
of the dermal toxicity and DFR studies^ The DFR study is due to EPA in October 1998 and the
dermal toxicity study is due to EPA in December 1998. . .
Occupational-Use Products (NonWPS Uses)
Since EPA has concerns about post-application exposures to persons after-nonWPS
occupational uses of dicofol, it is establishing entry restrictions for all nonWPS occupational uses of
dicofol end-use products. The Agency has determined that restricting entry into treated areas after
liquid applications until sprays have dried is a prudent safety practice applicable at the nonWPS use-
sites where dicofol will be applied.
e. Other Labeling Requirements
The Agency is also requiring^other use and safety information to be placed on the labeling of
all end-use products containing dicofol. For the specific labeling statements, refer to Section V of
this document. , ;
7. Restricted Use Classification
Dicofol does not require and is not being considered for restricted use.
8. Endangered Species Statement
The Endangered Species Protection Program is expected to become final in the future:
Limitations in the use of dicofol will be required to protect endangered and threatened species, but
these limitations have not been defined and.may be formulation specific/The Agency 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 informed 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. . '
i
9." Spray Drift Advisory ,
The Agency has been working with the Spray Drift Task Force, EPA Regional Officesand State
Lead Agencies for pesticide regulation to develop the best spray drift management practices. The
Agency is now requiring interim measures that must be placed on product labels/labeling as specified
in Section V. Once the Agency completes its evaluation of the new data base submitted by the Spray
Drift Task Force, a membership of U.S. pesticide registrants, the Agency may impose further
refinements in spray drift management practices to further reduce off-target drift and risks associated
with this drift. .
129
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V. ACTIONS ^QUIRED OF REGISTRANTS AND OTHERS
This section specifies the conditions (data requirements, label changes, and other responses)
necessary for the reregistration of both manufacturing use and end use products.
A. Manufactured Use Products
, ; , ' ^ .'^"^t ' , ,
1. Additional Generic Data Requirements
The generic database supporting the reregistration of dicofol for the uses covered in this RED
has been reviewed and determined to be substantially complete.
The following confirmatory data are required:
" * Additional confirmatory data are required to support the established tolerances for the
crop group caneberries, 860.1500 (171-4K). A minimum of 3 additional trials are
required on blackberries or raspberries from three different geographical regions. IR4
is expected to supply these data. (See Appendix B) .
ป Field trials are required for cotton gin byproducts, 860.1500 (171-4L). The requirement
for cotton gin byproduct data is a recent development under new OPPTS guidelines.
(Series860.1.000) (Pesticide ReregistrationRejectionRate Analysis Residue Chemistry:
Follow-Up Guidance for Updated Livestock Feeds Tables (06/94, EPA 738-K-94-001;
revised 09/95)).
" Additional data are required for the following product chemistry guidelines for dicofol:
830.1550 (158.155); 830.6314 (63-14); 830.6315 (63-15); 830.6316 (63-16); 830.6319
(63-19); and 830.1750 (158.175). (See Appendix B)
* Data are required for 830.7050, UV/visible absorption. This is a new end use product
requirement in conjunction with OECD (OECD number 101).
The registrants must either certify that the suppliers of starting materials and the
manufacturing process for the dicofol products have not changed since the last
comprehensive product chemistry review or submit complete updated product chemistry
data packages.
With regard to the subchronic feeding study in rodents (Guideline No. 82-1, 870.3150)
data on the analyses of the tissue residues of the test compound should be submitted
(MRBD 47015801).
i
" The Agency is waiting for data regarding post-application exposure for occupational use
Sites. The> DFR data is due in October, 1998, in response to the Agricultural Reentry
Data Call-in (1995-) untH these data are submitted and evaluated, the post-application
use scenarios remain a concern.
130
-------
The Wettable Powder/Dust (WP/D), formulation labels must be amended such that the
application rate and PHI for strawberries are consistent with the requirements specified
in this RED. The Emulsifiable Concentrate (EC) labels which still contain strawberry use
must be amended to delete that crop (Guideline No. 171-3) (860.1200) (Appendix B).
-.' For 860.1340 (Guideline No. 171-4C,D), Residue AnalyticalMethods, method TR-310-
86-74 for plant matrices must be validated by an independent laboratory (ILV)
(Appendix B).
Tolerances are needed for ruminant and poultry commodities.
The registrants must submit a developmental neurotoxicity study in rats, Guideline No.
83-6 (870-6300). This study is now required since dicofol produces neurotpxic effects
in adult rats. .
As a result of a Data Call In from October 13, 1995, the registrants must also submit a
DFR. study, due in October, 1998. ,
Required Occupational/Residential Exposure Studies and Recommendations -
Handler (mixer/loader and/or applicator) exposure data were required from a previous DCI
,(March3,1995 and October 30,1995J. This data is being developed by the Ag Reentry Task Force.
Rohm and Haas is a member of this task force and the Agency will review that data when it is
received.
2. Labeling Requirements for Manufacturing Use products
To remain in compliance with FIFRA, manufacturing use (MP) labeling must be revised to
comply with all current EPA regulations, PR notices, and application policies. The MP labeling must
bear the labeling contained in Table 40 at the end of this section. _ / ,
B. . End Use Products
1. Additional Product Specific Data 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. While the Agency has not
yet determined dicofol to be eligible, these product specific data requirements can be found in
Appendix D, the Generic and Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure they meet currentEPA acceptance
criteria (Appendix D, Generic and Product Specific Data Call Notice) and, if not, commit to conduct
new studies. If a registrant believes that previously submitted data meet current testing standards,
131
-------
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then the study MRJD numbers should be cited according to the instructions in the requirement Status
and registration Response Form provided for each product.
2. Labeling Requirements for End Use Products
t i
All end use product labels should be amended-so they are in compliance with basic producer
labels.
All end-use products should have clear, concise,and complete labeling instructions in
acc?ฐrdance with Table 40. Proper labels can improve reader understanding, thereby reducing misuse
and the potential for incidents. Towards this end, the Agency is requiring the following:
Directions for Use:
Directions for Use must be stated in terms that can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide. It must be presented in a format that is
easy to understand and follow. The Directions for Use section of a pesticide label must provide the
necessary information to answer four major questions regarding the use of the pesticide. These four
questions are:
1. Why is the pesticide being used? (For what pest(s) or problem?)
2. Where is the pesticide applied? (Where should it not be applied?)
3. How is the pesticide applied? (What special precautions must the user take? How much
should they use?)
4. When should the pesticide be applied?
In addition, the Agency encourages the use of graphic symbols whenever possible, to clarify the
written label.
National Pesticide Telecommunications (KPTM) Hotline Number
All dicofol labels must refer consumers to the NPTN number for additional information. This
reference must bear the labeling contained in Table 40 at the end of this section.
First Aid (Statement of Practical Treatment}
The Agency is requiring that all labels with Statement of Practical Treatment sections be
a'mended so that these sections are entitled, "First Aid." First aid statements must be brief, clear,
simple and in straightforward language (conforming to the labeling required by the Agency) so that
the average person can easily and quickly understand the instructions. These statements should be
appropriate for all ages or, when necessary, should include distinctions between the treatments for
different ages.
132 .
-------
. Table 40 summarizes the labeling requirements being imposed by. this RED for all dicofol
products. Any use instructions on current labels that conflict with those listed below should be
removed. .
For sole-active-ingredient end-use products that contain dicofol:
Revise the product labeling to adopt the mixer/loader/applicator personal protective
equipment/engineering control requirements set forth in this section.
Revise the product labeling to adopt the entry restrictions which will be set after the
Agency reviews DFR data and dermal toxicity data, due in October 1998, and December
1998, respectively.
For multiple-active-ingredient end-use products that contain dicofol:
Compare the mixer/loader/applicator personal protective equipment/engineering control
requirements set forth in this section to the requirements on the current labeling.
Retain the more protective requirements, (For guidance on which requirements are
considered more protective, see PR Notice 93-7.) '. '
. Compare the entry restrictions which will be set to the entry restrictions on the current
labeling.
Retain the more protective restrictions. (A specific time period in hours or days is
considered more protective than "sprays have dried" or "dusts have settled.")
The PPE that .would be established on the basis of the acute toxicity category of the end-use
product must be compared to the active-ingredient specific personal protective equipment specified
above. The more protective PPE must be placed on the product labeling. For guidance on which PPE
is considered more protective, see PR Notice 93-7.
133
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forest, nursery, or greenhouse must comply with the labeling requirements of PR Noi
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Guidance for PR Notice 93-7," which reflect the requirements of EPA's labeling regi
protection statements (40 CFR part 156, subpart K). These labeling revisions are nee
Worker Protection Standard for Agricultural Pesticides (40 CFR part 170) and must 1
accordance with, and within the deadlines specified in, PR Notices 93-7 and 93-1 1. 1
specifically directed in this RED, all statements required by PR Notices 93-7 and 93-
product label exactly as instructed in those notices.
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Applicators and other handlers must wear:
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of increasing pressure.
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larger droplets than other orientations and is the recommended practice. Signifies
horizontal will reduce droplet size and increase drift potential.
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narrower spray angles produce larger droplets. Consider using low-drift nozzles.
oriented straight back produce the largest droplets and the lowest drift."
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exposure of droplets to evaporation and wind."
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patterns. Every applicator should be familiar with local wind patterns and how they affect spray drift."
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"TEMPERATURE INVERSIONS" ' , ' '
"Applications should not occur during a temperature inversion because drift potential is high. Temperature
inversions restrict vertical air mixing, which causes small suspended droplets to remain in a concentrated
cloud. This cloud can move in unpredictable directions due to the light variable winds common during
inversions. Temperature inversions are characterized by increasing temperatures with altitude and are
common on nights with limited cloud cover and light to no wind. They begin to form as the sun sets and
often continue into the morning. Their presence can be indicated by ground fog; however, if fog is not
present, inversions can also be identified by the movement of smoke from a ground source or an aircraft
smoke generator. Smoke that layers and moves laterally in a concentrated cloud (under low wind
conditions) indicates an inversion, while smoke that moves upward and rapidly dissipates indicates good
vertical air mixing:"
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C. Existing Stocks
. Registrants may generally distribute and sell products bearing old labels/labeling for 26 months from
the date of the issuance of this Reregistration Eligibility Decision (RED). Persons other than the registrant
may generally distribute or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case by case, depending on the number of products
involved, the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide Products;
Statement of Policy;" Federal register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell dicofol products bearing old
labels/labeling for 26 months from the date of issuance of this RED. Persons other than the registrant remain
obligated to meet preexisting Agency imposed label changes and existing stocks requirements applicable to
products they sell or distribute.
143
-------
I III 11
III 11 II
144
-------
VI. APPENDICES
145
-------
I I
II I I I II II I II
III I llfl 111 1 111
-------
Appendix A - Table of Use Patterns Subject to this RED
Appendix A is 46 pages long and is not being included in this RED. Copies of Appendix A are
available upon request per the instructions in Appendix E. , , ...
146
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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 0021 covered by this Reregistration Eligibility Decision Document. It
contains generic data requirements that apply to 0021 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 CFRPart 158. the reference numbers accompanying each testjefer 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
O Indoor residential
3- Bibliographic citation fColumn 3) Ifthe 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 MRP number has been assigned. Refer to the Bibliography
appendix for a complete citation of the study.
: 147
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GUIDE TO APPENDIX C
1. 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.
2. 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 subject), 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.
3. 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.
4. 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. 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.
b. 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 (19??), the Agency was
unable to determine or estimate the date of the document.
161
-------
^
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
ซ j
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
[ [ "_"'' ' "J*.number., or other a^mmistratire
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,j,ง j^tumjollowed by an alphabetic suffix which shows the relative
position of the study within the volume.
162
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BIBLIOGRAPHY
MRID
CITATION
00004272
00004275
00004305
00004321
00004322
00004323
00004324
00004341
00004358
00004371
Rohm and Haas Company (1961) Report: Analytical Results of Residue on
Peppermint Hay. (Unpublished study received Jun 17, 1965 under PP03 90;
CDL:090422-B) '
Gordon, C.F. (1962) Dichlorobenzhydrol in Mint Oil. Includes method dated
Dec 4; 1962. (Unpublished study received Jun 17, 1965 under PP0390;
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:090422-M)
Rohm and Haas Company (1957) Explanatory Notes on Residue Data.
(Unpublished study received pet 12, 1957 under PP0154; CDL: 090180-K)
Rohm and Haas Company (1964) Kelthane in Mint Oil. Includes four undated
methods. (Unpublished study received Jan 28, 1966 under 6F0472'
CDL:090524-K)
Lawrence, S.C. (1964) Analytical Results of 4,4'-Dichlorobenzophenone .
(DCBP) Residue. (Unpublished study received Jan 28, 1966 under 6F0472;
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:090524-L)
Frick,.K.E.; Franzkeit, N.H. (1959) Pesticide Residue Analysis. (Unpublished
study received Jan 28, 1966 under 6F0472; prepared by State College of
Washington, Dept of Entomology and Agricultural Chemistry, Prosser Irrigation
Experiment Station, submitted by Rohm & Haas Co., Philadelphia Pa
CDL:090524-M)
Terriere, ? (1963) Analytical Results of Kelthane Residue. (Unpublished study
received Jan 28, 1966 under 6F0472; submitted'by Rohm & Haas Co.,
Philadelphia, Pa.; CDL:090524-O)
Makhteshim Beer-Sheva Chemical Works;,Limited (1972) Acarin: Residue
Analysis. (Unpublished study received Jun 20, 1972 under 11678-7-
CDL:011016-C)
Rohm and Haas Company (19??) Technical Bulletin: KeltaneA(R>= Technical:
Agricultural Acaricide. (Unpublished study received Jun 26, 1972 under
707-107; CDL: 101453-A)
Rohm and Haas Company (19??) The Determination of Kelthafie Residues in
Lima Beans by Gas Liquid Chromatography. Undated method. (Unpublished
study received Aug 17, 1966 under 707-73; CDL: 101452-D)
163
-------
BIBLIOGRAPHY
CITATION
0"odo4420 Rohm and Haas Company (1961) Microdetermination of Kelthane in Plants,
Fruits and Vegetables. Method 1634-1 dated Nov 20, 196L (Unpublished
study received Jan 28; 1966 under 6F0472; CDL:092762-C)
00004426 Rohm and Haas Company (1967) Determination of Kelthane Residues in Crops
and Soils. Method dated Mar 13, 1967.. (j^R memorandum no. 518;
unpublished study received Mar 28, 1967 under 7F0590; CDL:092878-H)
00021662 Tea Research Association (1959) Tocklai Experimental Station-Annual
Report-i959. (pp. 251-254 only; unpublished study received Apr 29, 1966
under 6H2025; submitted by Rohm & Haas Co., Philadelphia, Pa.;
,'' ' ' CDL:221622-F)
00021668 Rohm and Haas Company (19??) Toxicolpgical Investigations. (Unpublished
study received" Apr 29, 1966 under 6H2025; CDL:221622-6)
00021680 Rohm and Haas Company (1957?) Analytical Procedure for the Determination of
4,4l-Dichiorobenzophenone ipDCBP'yin Tea uncjate"^ memod(Unpublished
study received Apr 29, 1966 under 6H2025; CDL:221622-AE)
iii ii ii iimi i'ii"."'"! i; ii'nl hll iiiiiH-iiiiiii;1--"; e* R'/i i is i >i < i*"i '',<ป ii, : W';":ปป" .i1 ,'n*, WE 'ivVi: 'Si'ป, ^--Viiii1 i ;i.5ii V '(! 'ii-I! i'!:1! ?, " S:' ',.,, i'i. '..ii! 'ij ! i:, i^it'S ''''iiiSiii1* iiii' iiiiiiii'
00021683 Cranham, J.E. (1962) Analytical Results: Kelthane in Brewed Tea. (Unpublished
study received Apr 29, 1966 under 6H2025; submitted by Rohm & Haas Co,
Philadelphia, Pa.; CDL:221622-AI)
00021700 Rohm & Haas Cpmpany (19??) Summary of Residue Reports Submitted
Previously with Pesticide Petitions No. 6F0472 and 7G0512. (Unpublished
study received Jun 19, 1967 under 7F0590; CDL: 090757-E)
00021701 Lawrence, S.C.; Chollet, C.C. (1966) Analytical Results of Kelthane Residues.
(Unpublished study received Jun 19, 1967 under 7F0590; submitted by Rohm &
Haas Co., Philadelphia, Pa.; CDL: 090757-F) ,
00022895 Rohm & Haas Company (1956) Kelthane Residues on Hops. (Unpublished
study received Jan 22, 1957 under unknown admin, no.; CDL: 124265-C)
00051013 Tea Research Institute of Ceylon (1965) Letter sent to G. A. Misner dated Jan 6,
1965: Kelthane for control of mites on Ceylon tea. (Unpublished study received
Apr 29, 1966 under 6H2025; submitted by Rohm & Haas Co., Philadelphia, Pa.;
;_; ;;;; | CDL:221622-C) ' . .
164
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BIBLIOGRAPHY
MRID
CITATION
00051015
00141578
00141580
00141704
00142595
00143704
00143708
00143715
00145489
00146518
00149734
Gordon, C.F. (1960) Letter sent to F.B. Maughan dated May 17, 1960: Kelthane
in brewed tea. (Unpublished study received Apr 29, 1966 under 6H2025;
submitted by Rohm & Haas Co., Philadelphia, Pa.; CDL:221622-AF)
i . '._ ; ' .
Keeney, J. (1984) Determination of the Octanol/Water Partition Coefficient
(KOW) for ER-8 ..,: En-Cas Job #83-177, Part 1, Unpublished Rohm and Haas
Technical Report No. 31L-84-04 prepared by En-Cas Analytical Laboratories 7
P- '.'-,'. ' . "'".."'.- '.'..'
Keeney, J. (1984) Hydrolysis Study of ER-8 :..: En-Cas Job #83-177, Part 2.
Unpublished Rohm and Haas Technical Report No. 31L-8403 prepared by '
En-Cas Analytical Laboratories. 26 p.
Rohm & Haas Co. (1984) FProduct Chemistry: Kelthane Miticidesa.
Unpublished study. 19 p. ,
Rohm and Hass Co. (1984) Addendum to Generic Product Chemistry Data
Submitted April 30, 1984. Unpublished study. 4 p.
.Parker, C.(1979) fCarbon-14a-Kelthane Residues in/on DryBeans: Technical
Report No. 34F-79-25. Unpublished study prepared by Rohm and Haas Co 22
P-
Rohm and Haas Co. (1981) Kelthane Technical... Product Composition.
Unpublished compilation. 8 p.
Rothman, A. (1981) Water Solubility of ER-8;Technical Report No. 7487.
Unpublished study prepared by Rohm and Haas Co. 14 p.
Rohm and Haas Company (1984) Addendum to Generic Product Chemistry
Data. Unpublished study. 7 p.
Shaffer, S. (1985) Determination of (Carbon 14a-dicofol, pCarbon 14a-ER-8
and Carbon 14a-pp DDE Residues in Poultry Samples from Hens Orally Dosed
with FCarbon 14a-dicofol for Seven Days: ABC Preliminary Report #33000.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, 34 p.
Rohm and Haas Co, (1985) Kelthane Technical: Certification of Limits: FProduct
Chemistry Dataa. Unpublished study. 3 p.
165
-------
MRID
00150402
00151059
00151207
00 1 54970
00 1 $497 1
i mi in i in i i
00161 079
1 i
00 1 62966
00163337
00163338
BIBLIOGRAPHY
CITATION
Agan Chemical Manufacturers Ltd. (1984) pProduct Chemistry of Acarin
Technicalo. Unpublished compilation. 13 p.
Schlesinger, H. (1985) pp,p'-bicofol Product Chemistrya: Vapor Pressure.
Unpublished study prepared by Analyst Ltd. 10 p.
m and ]&m$, ,(1985) ^Compositional Formula pea: pKelthane EC Miticide,
Ketiane 35 Agricultural Miticide Wettable Powder and Kelthane MF (417)a.
Unpublished compilation. 3 p.
OQ151575 Agan Chemical Mfg. Ltd. (1985) Product Identity and Disclosure of Ingredients
ppfAcarina. ^Unpublished compilation. 49 p.
00151576 Agan Chemical Mfg. Ltd. (1985) Preliminary Analysis of Product Samples pand
Certification of Ingredients in Acarina. Unpublished compilation. 27 p.
00151577 Agan Chemical Mfg. Ltd. (1985) pPhysical and Chemical Characteristics of
Acarino. Unpublished compilation. 49 p.
00154969 Makhteshim-Agan (America) Inc. (1985) Product Identity and Composition:
Acarin. Unpublished compilation. 29 p.
Makhteshim-Agan (America) Inc. (1 985) Analysis and. Certification of Product
Ingredients: Acarin. Unpublished study, lip.
' / ' '
Makhteshim-Agan (America) (1985) Physical and Chemical Characteristics:
Acarin. Unpublished study. 28 p.
iiiiiiiiiii i ill i i in i i i i i i ij^ H n i i i T in H f ii i j
Rohm & Haas Co. (1984) Product Chemistry: Kelthane Technical. Unpublished
MM i iiiiii 1 1 i i i ii i in ii in ' t J " , ,
compilation. 86 p.
Rohm and Haas Co. (1 986) Kelthane Product Chemistry. Unpublished
compilation. 138 p.
Agan Chem. Co., Inc. (1986) Preliminary Analysis of Product Samples: pMitigan
(Dicofol) Technicala. Unpublished study. 32 p.
Agan Chem. Co., Inc. (1986) Solubility: pof Mitigan (Dicofol) Technicalo.
Unpublished study. 1 p.
166
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BIBLIOGRAPHY
MRID
CITATION
00164070
00164383
00265330
05004945
05004951
05005141
05005165
05005167
05005274
05005537
Rohm and Haas .Co. (1986) Kelthane Product Chemistry. Unpublished
compilation. 175 p.
Hodosh, R. (1986) Letter sent to D. Edwards dated Oct 28, 1986: Mitigan
(Dicofol) technical: Product Chemistry submitted in response to EPA letter of
September 26, 1986. Prepared by Makhtestom-Agan (America) Inc. 16 p.
Tillman, A. M. 1986. The bioconcentration, elimination and metabolism of
14C-dicofol by bluegill sunfish (Lepomis microchirus). Report No. 310-86-17,
prepared and submitted by Rohm and Haas Company, Philadelphia, PA
Eiduson, H.P. (1961) The determination of Kelthane residues on fruits and
vegetables. Journal of the Association of Official Agricultural Chemists
44(2): 183-188. . , ;
Gunther, FA.; Blinn, R.C. (1957) Ultraviolet spectrophotometric
microdetermination of the acaricide
4,4l-dichloro-alpha-(trichloromethyl)benzhydrol (FW-293). Journal of
Agricultural and Food Chemistry 5(7):517-519.
Ives, N.F. (1973) Observations on the gas chromatography of Kelthane (dicofol).
Journal of the Association of Official Analytical Chemists 56(6):1335-1338.
Gordon, C.F;; Haines, L.D.; Martin, J.J. (1963) An improved method for
Kelthane residue analysis with applications for determination of residues in milk.
Journal of Agricultural and Food Chemistry ll(l):84-86.
George, D.A.; Fahey, J.E.; Walker, K.C. (1961) A modification of the Rosenthal
method for rapid determination of Kelthane residues. Journal of Agricultural and
Food Chemistry 9(4):264-266.
Rosenthal, I; Frisone, G.J.; Gunther, FA. (1957) Colorimetric
microdetermination of the acaricide
4,4'-dichloro-alpha-(trichloromethyl)benzhydrol (FW-293). Journal of
Agricultural and Food Chemistry 5(7):514-517. .
Moats, W. A. (1966) Analysis of dairy products for chlorinated insecticide
residues by thin layer chromatography. Journal of the Association of Official
Analytical Chemists 49(4):795-800.
167
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BIBLIOGRAPHY
MRID CITATION
05006330 Morgan, N.L. (1968) Separation of dicofol (Kelthane) and its
dichlorobenzophenene degradation product from a standard Florisil column.
Bulletin of Environmental Contamination and Toxicology 3(4):254-257.
65006528 Scheel, D.; Sandermann, H., Jr. (1977) Metabolism of DDT and Kelthane in cell
suspension cultures of parsley (tHPetroselinum- u~hortenseu~ Hoffm ) and
!i||j| |l||i|| ....... ' ] i]:!1'!'!''!!'! ป Ifl'll ,, ||||||||| | III | II I I J ' *"~"^
soybean (u~Glycine max~L_). Planta 133(3):3 15-320.
", ....... nip1' in;, 'i i i wsjiiiiiii < ijii iiii-'i'ii'i ' I
05012262 Katz, D. (1964) Beitrag zum Problem der Sichtbarmachung von chlorierten
Insektiziden am Duennschichtc^omatogramrn_ [A contribution to the problem
of coloring the spots of chlorinated insecticides in the thin-layer chromatogramj
Journal of Chromatography 15 (2): 269-272.
Ililu, ''IPI',, 'I'll Illll T ,' ...... l',,,i |. i ..... ........... ,,i,<
0501 7942 Kashiwa, T.; Onda, K.; Ito, F. (1 965) Kanshiki ususo kuromatogurafi niyoru
kerutanu seizai no bunseki_ [Dry thin-layer chromatographic determination of
Kelthane formulationsj Bunseki Kagaku. [Japan Analyst] 14(3):207-212.
' ' \ ' , ,
05019781 Mitchell, L.C (1958) Separation and identification of chlorinated organic
pesticides by paper chromatography_ XI_ A study of 114 pesticide chemicals:
!itii'' '-i^ ''>. ..... ^ Sf^M-i ..... *-5;p^
Association of Official Agricultural Chemists 41(4):781-816.
4000 1 20 1 Zbgrowslki, G. (1 986) Mitigati picofol Technical: Composition of Dicofol.
:ii;' , :;ซ, ; , ..... EVซT> ^Iri, UnpublisEed study prepared by Agan Chemical Manufactiarers Ltd. 32 p.
ril! \: , "!' , ji"1,", ! 'jr ,' i!!iiii!iiiii!!!i ....... 'I'l!1!, >: ;.|i' *!'!. 'i;/!',:!,,iiiiป '..siii1"!!' 1i!!!ii!! ,: i '.aiiitiVjiif'ww^^^ siliiyiiiK1;,,.!!,!,'''1!!. ," i: '":,!,': ^x'vn, i,:;!?'1?1 ;'f;:n ...... Lซ t1" .lit v"'!1'"^ ,1" !r i'ilvM ,;'ป " iliiJiป ' 'i '* ซ^^/'a'V*^\*nl !: 'ii'Vw!1 .r '',? jy,r:'"l '"I i/'',ftiii' i/'fr!^ \
40004801 Staff, Agan Chemical Manufacturers Ltd. (1986) Additional Product Chemistry
Information: Mitigan Dicofol Technical: EPA Reg. No. 1 1603 26. Unpublished
compilation. 56 p.
40042001 Teeter, D. (1986) Determination .of the Octanol/Water Coefficient of pCarbon
14o-p,p'-Dicofol: Technical Report No. 3 10-86-36: ABC Final Report No.
34623. Unpublished study prepared by Rohm and Haas Co. in cooperation with
Analytical Bio-Chemistry Laboratories, Inc. 81 p.
......................... | ..... ; .............. ' , , , ' , ; ................. ' ;;':;;
40042002 Teeter, D. (1 986) Determination of the Octanol/Water Coefficient of fCarbon
14o-o,p'-Dicofol: Technical Report No. 310-86-37: ABC Final Report No.
34621. Unpublished study prepared by Rohm and Haas in cooperation with
Analytical Bio-Chemistry Laboratories, Inc. 77 p.
ill pi| I i nil
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168
1 1 n ii ni in ..... i n i LI 1 1 i i iii 1 1 1 him ii ii in hi in 1 1 n iiiii i PI n1 1 P iiiiginiiiiii ปn HIM i iiii iซii ini nni in inn i i mi I
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!!! iiii|iihiiiiiiii i mi ||iiiiiigiiii
-------
BIBLIOGRAPHY
MRID
CITATION
40042003
40042004
40042005
40042006
40042007
40042008
40042009
40042010
40042011
Tillman, A. (1985) A Metabolism Study of fCarbon 14a-Dicofol in Grapefruit:
Rohm and Haas Technical Report No. 31L-85-25. Unpublished study prepared
by Rohm and Haas Co. 449 p. ' " '
Tillman, A. (1986) Metabolism of fCarbon 14a-p,p'-Dicofol in Cottonseeds:
Rohm and Haas Technical Report No. 310-86-69. Unpublished study prepared
by Rohm and Haas Co. ,126 p.
Tillman, A. (1986) Metabolism of pCarbon 14a-o,p'-Dicofol in Cottonseeds:
Rohm and Haas Technical'Report No. 310-86-70. Unpublished study prepared
by Rohm and Haas Co. 108 p. , '
Deckert, F.; Predmore, L.; Williams, M. (1986) Dicofol-Nature of the Residue
in Lactating Dairy Goats: Technical Report No. 31086-61: ABC Final Report
No. 32025. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Bio-Chemistry Laboratories, Inc. 363 p.
Deckert, F.; Jameson, C.; Shaffer, S. (1986) Dicofol-Nature of the Residue in
Laying Hens: Rohm and Haas Technical Report No. 310-86-68: ABC Lab Study
No. 32480. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Bio-Chemistry Labs. 200 p.
Hofmann, C. (1986) A Residue Analytical Method for p,p'-Dicofol and
o,p'-Dicofol: Rohm and Haas Technical Report No.'310-86-74. Unpublished
study prepared by Rohm and Haas Co. 166 p.
Pollock, R. (1986) Interim Report on the Stability of p,p'-Dicofolin Cottonseed
Products under Frozen Storage Conditions after 18 Months: Rohm and Haas
Technical Report No. 310-86-51. Unpublished study prepared by Analytical
Development Corp. 79 p. ,
Pollock, R. (1986) Interim Report on the Stability of o,p'-Dicofol in Cottonseed
Products under Frozen Storage Conditions (10 Months): Rohm and Haas
Technical Report No. 310-86-46. Unpublished study prepared by Analytical
Development Corp. 172 p.
Hofmann, C. (1986) A Study on the Stability of Dicofol and Its o,p' Isomer
(o,p'-Dicofol) on Citrus in a Frozen Storage Environment: One Year Report:
Rohm and Haas Technical Report No. 310-86-24. Unpublished study prepared
by Rohm and Haas Co. 28 p.
169
-------
BIBLIOGRAPHY
MRlD
CITATION
40042012
40042013
i i
i i iii
40042014
40042015
40042016
40042017
40042018
40042019
40042020
40042021
Mazza, L. (1986) Kelthane Residues in Citrus: Rohm and Haas Analytical
Report No. 31A-86^81. Unpublished study prepared by Rohm and Haas Co. in
cooperation -with Analytical Development Corp. 357 p.
Mazza, L. (1986) Kelthane Residues in Citrus: Analytical Report No.
31A-86-85. Unpublished study prepared by Rohm and Haas Co. in cooperation
wi|Jj Analytical Development: Corp. 78 p.
Mazza, L. (1986) Kelthane Residues in Apples: Rohm and Haas Analytical
Report No. 31A-86-68. Unpublished study prepared by Rohm and Haas Co. in
cooperation With Analytical Development Corp. 241 p.
i \
Mazza, L. (1986) Kelthane Residues in Pears: Rohm and Haas Analytical Report
No. 31A-86-79. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Analytical Development Corp. 82 p.
Mazza, L. (1986) Kelthane Residues in Pears: Analytical Report No. 31A-86-87.
Unpublished study prepared by Rohm and Haas Co. in cooperation with
Analytical Development Corp. 27 p.
Mazza, L. (1986) Kelthane Residues in Dry Beans: Rohm and Haas Analytical
Report No. 31A-86-64. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Analytical Development Corp. 236 p.
Mazza, L. (1986) Kelthane Residues in Melons: Rohm and Haas Analytical
Report No. 31A-86-55. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Analytical Development Corp. 25 p.
Mazza, L. (1986) Kelthane Residues in Melons: Analytical Report No.
31A-86-88. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Development Corp, 144 p.
m" ." - , .',''
Mazza, L. (1986) Kelthane Residues in Cucumbers: Analytical Report No.
31A-86-86. Unpublished study prepared by Rohm and Haas Co. in cooperation
With Analytical Development Corp. 184 p.
Mazza, L. (1986) Kelthane Residues in Squash: Analytical Report No.
31A-86-89. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Development Corp. 156 p.
170
-------
BIBLIOGRAPHY
MRID
CITATION
40042022
40042023
40042024
40042025
400.42026
40042027
40042028
40042029
40042030
40042031
Mazza, L. (1986) Kelthane Residues in Pecans: Rohm and Haas Analytical
Report No. 31A-86-83. Unpublished study prepared by Rohm and Haas Co. in
.'cooperation with Analytical Development Corp. 41 p.
Mazza, L. (1986) Kelthane Residues in Walnuts: Analytical Report No.
31A-86-84. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Development Corp, 119 p.
Mazza, L. (1986) Kelthane Residues in Grapes: Analytical Report No.
31A-86-90.' Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Development Corp. 208 p. .,
Mazza, L. (1986) Kelthane Residues in Cotton Seed: Analytical Report No.
31A-86-76. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Development Corp. 290 p.
'"'..' ' '
Mazza, L. (1986) Kelthane Residues in Processed Apple Products: Rohm and
Haas Technical Report No. 310-86-48. Unpublished study prepared by Rohm
and Haas Co..in cooperation with Analytical Development Corp. 218 p.
Mazza, L. (1986) Kelthane Residues in Processed Cotton: Technical Report No.
310-86-42. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Development Corp. 135 p.
Mazza, L. (1986) Kelthane Residues in Processed Grape Products: Technical
Report No. 310-86-66. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Analytical Development Corp. 171 p. ,
Mazza, L. (1986) Kelthane Residues in Processed Citrus Products: Technical
Report No. 310-86-67. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Analytical Developmenf Corp. 137 p.
Predmore, L.; Shaffer, S. (1986) A Feeding Study with Cows Dosed with
Technical Kelthane and Preliminary Report on the Analysis of Tissue and Milk
Samples: Rohm' and Haas Technical Report No. 310-86-57: ABC Final Report
. No. 34826. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical Biochemistry Laboratories. 133 p.
Jameson, C:; Shaffer, S. (1986) A Feeding Study with Hens Dosed with
Technical Kelthane and Preliminary Report on the Analysis of Tissue and Egg
Samples: Rohm and Haas Technical Report No. 310-86-56: ABC Final Report
171
-------
BIBLIOGRAPHY
MRID
CITATION
40042032
40042033
40042034
III I L
40042035
40042036
40042037
40042038
No, 34828. Unpublished study prepared by Rohm and Haas Co. in cooperation
with Analytical BioChemistry Laboratories. 138 p.
Warren, J. (1986) Hydrolysis of pCarbon 14o-p,p'-Dicofol (Kelthane): ABC
33351: Rohm and Haas T.R. No. 310-86-59. Unpublished study prepared by
Roto and Haas Co. in cooperation with Analytical Bio-Chemistry Laboratories.
719 : ' : ; -
Warren, J. (1986) Hydrolysis of fCarbon 14a-o,p'-Dicofol (Kelthane): ABC
34618: Rohm and Haas T.R. No. 310-86-58. Unpublished study prepared by
Rohm and Haas Co. in cooperation with Analytical Bio-Chemistry Laboratories.
63 1 p.
I i ,1 *
Carpenter, M. (1986) Aqueous Photolysis of pCarbon 14a-p,p'-Dicofol
(Kelthane^: ABC Final Report No. 34277: Rohm and Haas Technical Report No.
3 1 O-sS-'&if ! UnpuBlish'ed study prepared by Rohm and Haas Co. in cooperation
with Analyfical Bio-Chemistry Laboratories. 1033 p.
Carpenter, M. (1986) Aqueous Photolysis of (Carbon 14o-o,p'-Dicofol
(Kelthane): ABC Final Report No. 34466: Rohm and Haas Technical Report No.
310-86-65. Unpublished study prepared by Rohm and Haas Co. in cooperation
ซ2j:'WiA Analytical Bio^hemis^ Laboratories. 820 p.
Carpenter, M. (l9ง6)'Mdt6degradati6n'bf pCarbon14a-p,p'-bicofol on me
Surface of Soil: ABC Final Report No. 34278: Rohm and Haas Technical Report
No. 310-86-50. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Analytical Bio-Chemistry Laboratories, Inc. 483 p.
V f J J
Carpenter, M. (1986) Photodegradation of pCarbon 14o-o,p'-Dicofol on the
Surface of Soil: ABC Final Report No. 34465: Rohm and Haas Technical Report
No. 310-86-49. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Analytical Bio-Chemistry Laboratories, Inc. 289 p.
Daly, D.; Tillman, A. (I986) Four Month Interim Report on the Aerobic
Metabolism of fCarbon Ma-o.p'-bicofol on Silt Loam Soil: ABC Interim Report
No,34620: Rohm and Haas Technical Report No. 310-86-47. Unpublished
study prepared by Analytical Bio-Chemistry Laboratories, Inc. 432 p.
172
nil ill
-------
BIBLIOGRAPHY
MRID
CITATION
'40042040.
40042041
40.042039 Daly, D.; Tillman, A. (1986) Anaerobic Metabolism of FCarbon 14ap,p'-Dicofol
. on Silt Loam Soil: ABC Labs Final Report No. 33350: Rohm and Haas
Technical Report No. 310-86-41. Unpublished study prepared by Rohm and
Haas Co. in cooperation with Analytical Bio-Chemistry Labs. 380 p.
Hofmann, C. (1986) A Field Dissipation Study of Kelthane Miticide in Fresno,
CA: Rohm and Haas Technical Report No. 310-86-72. Unpublished study
prepared by Rohm and Haas Co. in cooperation with Enviro-Bio-Tech, Ltd. 512
p. - . , *' . ' '
Hofmann, C. (1986) A Field Dissipation Study of Kelthane Miticide in
Cleveland, Ms.: Rohm and Haas Technical Report No. 310-86-71. Unpublished
study prepared by Rohm and Haas Co. in cooperation with Enyiro-Bib-Tech
Ltd. 439 p. " .'
Hofmann, C. (1986) Dicofol-Confined Accumalation Studies on Rotational
:- Crops: Technical Report No. 310-86-60. Unpublished study prepared by Rohm
and Haas Co. 148 p.
Shellenberger, T. (1986) Dicofol (Kelthane Miticide): Three Month Dietary
Toxicity Study in Dogs: Final Report: Testing Facility Report No, 85014:
Sponsor's Report No. 86RC-23. Unpublished study prepared by Tegeris
Laboratories, Inc. 1159 p.
Goldman, P.; Harris, J. (1986) Dicofol (Kelthane Technical Miticide): Three
Month Dietary Toxicity Study in Mice: Report No. 85R-104: Protocol No.
85P-018. Unpublished study prepared by Rohm and Haas Co. 381 p.
Hoberman, A.; Christian, M. (1986) Dicofol (Kelthane technical Miticide): A
Developmental Toxicity Study of Dicofol Administered Via Gavage to
Crl:COBS CD (SD)BR Presumed Pregnant Rats: Testing Facility Study No.
, ' ' 018-010: Sponsor's Report No. 85RC69. Unpublished study prepared by Argus
Research Laboratories, Inc. in cooperation with Rohm and Haas Co. 376 p.
40042047 Hoberman, A.; Christian, M. (1986) Dicofol (Kelthane Technical Miticide): A
Developmental Toxicity Study of Dicofol Administered Via Stomach Tube to
New Zealand White Rabbits: Testing Facility Study No, 018-009,: Sponsor's
Report No. 86RC-15. Unpublished study prepared by Argus Research
Laboratories in cooperation with Rohm and Haas Co. 420 p.
40042042
40042043
40042044
40042046
173
-------
BIBLIOGRAPHY
MRID
CITATION
40042048
40042049
40042050
40042051
40042052
40042053
40042054
40042055
40042056
Higginbotham, C.; Byers, M. (1985) Dicofol (Kelthane Technical Miticide):
Microbial Mutagen Assay: Report No. 85R-0042: Protocol No. 85P-019.
Unpublished study prepared by Rohm and Haas Co., Toxicology Dept. 35 p.
f
Foxall, S.; Doolittle, D.; McCarthy, K. (1986) Dicofol (Kelthane Technical
Miticide): CHO/HGPRT Gene Mutagen Assay: Report No. 86R-002: Protocol
No. 85P-038. Unpublished study prepared by Rohm and Haas Co., Toxicology
Sames, I; Doolittle, D. (1986) Dicofol (Kelthane Technical Miticide): Kelthane
in vivo Cytogenic Study in Rats: Report No. 85R215: Protocol No. 84P-620R.
Unpublished study prepared by Rohm and Haas Co. 64 p.
Ivett, J.; Myhr, B. (1986) Dicofol (Kelthane Technical Miticide): In vitro
Cytogenic Assay in Chinese Hamster Ovary (CHO) Cells: Testing Facility Study
No, 20990: Sponsor's Report No. 85RC-0068. Unpublished study prepared by
Litton Bionetics, Inc. in cooperation with Rohm and Haas Co. 50 p.
Foxall, S.; Byers, M. (1 986) Dicofol (Kelthane Technical Miticide): In vitro
Unscheduled g^A Synthesis Assay: Report No. 85j[_202. Protocol 85P-129.
Unpublished study prepared by Rohm and Haas Co. 32 p.
i 1 i
Tillman, A.; Mazza, L.; Williams, M. (1985) Part I: Absorption and Excretion of
pCarbon 14a-DTc6l:bl ...... jn Mฃjg ^nd'Femaie '^teTP^^rAMietabolism ..... Study'oT, ......
pCarbon 14o--Dicofol in Male and Female Rats: ABC Final Report No. 33896:
Rohm and Haas Technical Report No. 31L-86-02. Unpublished study prepared
by Rohm and Haas Co. in cooperation with Analytical Bio-Chemistry Labs, Inc.
1127 p.
DiDonato, L,; Steigerwalt, R.; Longacre, S. (1986) o,p'-Dicofol and p,p'-Dicofol
Kinetic Study in Female Rats: Preliminary Data Summary: Report No. 86R-173:
Protocol No. 86P-206. Unpublished study prepared by Rohm and Haas Co.,
Toxicology Dept. 43 p. , .
Frank, P.; Beavers, J.; Jaber, M. (1986) Dicofol (Kelthane Technical Miticide):
A One-generation Reproduction with the Bob white (Colinus yirginianus):
Wildlife International Ltd. Project No. 129-126: RomT1 and fjaas Co. Report No.
86RC-47. Unpublished study prepared by Wildlife International Ltd. 134 p.
' i
McAllister, W.; Cohle, P.; Bowman, J. (1985) Dicofol (Kelthane Technical
Miticide): Acute Toxicity of Kelthane Technical to Rainbow Trout (Salmo
174
-------
BIBLIOGRAPHY
MRID
CITATION
40042057
40042058
40042059
40042060
40042061
40048503
40048506
gairdneri): Testing Facility Study No. 32806: Sponsor's Report No. 85RC-0016.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 66
P- . . .
Forbis, A.; Georgie, L.; Burgess, D. (1985) Dicofol (Kelthane Technical
Miticide): Acute-Toxicity of Kelthane Technical to Daphnia magna: Testing
Facility Study No. 32807: Sponsor's Report No. SSRCrOOH. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 45 p.
McAllister, W.; Cohle, P.; Bowman, J. (1985) Dicofol (Kelthane Technical
Miticide): Acute Toxicity of Kelthane Technical to Sheepshead Minnows
(Cyptinodon variegatus): Testing Facility Study No. 32808: Sponsor's Report
No. 85RC-0047. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. in cooperation with Rohm and Haas Co. 63 p.
Nicholson, R.; Surprenant, D. (1985) Dicofol (Kelthane Technical Miticide):
Acute Toxicity of Kelthane Technical to the Fiddler Crab (Uca pugilator):
Testing Facility Report No. #BW-85-8-1836: Sponsor's Report No. 85RC-60.
Unpublished study prepared by Springborn Bionomics, Inc. in cooperation with
Rohm and Haas Co. 19 p.,
Forbis, A.; Burgess, D.; Georgie, L. (1985) Dicofol (Kelthane Technical
Miticide): Acute Toxicity of Kelthane Technical to Mysid Shrimp (Mysidopsis
bahia): Testing Facility Study No. 32809: Sponsor's Report No. 85RC-0046.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. in
cooperation with Rohm and Haas Co. 52 p. - '
Ward, G. (1986) Dicofol (Kelthane Technical Miticide): Acute Toxicity of
Kelthane Technical on Shell Growth of the Eastern Oyster (Crassostrea
virginica): Testing Facility Report No. #85-351-0100-2130. Unpublished study
prepared by Environmental Science and Engineering, Inc. in cooperation with
Rohm and Haas Co. 33 p.
Shapiro, R. (1986) An Acute 4-hour Inhalation Toxicity Study in Rats: (Dicofol
Mitigan Technical): Laboratory Project ID: T6069. Unpublished study prepared
by Product Safety Labs. 51 p.
Shapiro, R. (1986):EPA Guinea Pig Sensitization Test: (Dicofol Mitigan
Technical): Laboratory Project ID: T6070! Unpublished study prepared by
Product Safety Labs. 21 p.
175
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l! !! ..... ilSHiflillHW
..... . In)1 "Iki ...... ,'"(?. Hi St* ill1' i'tttll ...... i-'JJT*; '-'I, ........... > ...... ' Ml1"
BIBLIOGRAPHY
MRID
CITATION
40297201 Agan Chemical Manufacturers Ltd. (1987) Additional Product Chemistry
Information: Mitigan (Dicofol) Technical. Unpublished study. 191 p.
40460101 Carpenter, M. (1987) Supplement to Photodegradation of .
[Carbon-14]p,p'-Dicofol on the Surface of Soil...: Technical Report No.
31C-87-49. Unpublished report. 8 p.
40460103 Carpenter, M. (1987) Supplement to Photodegradation of [Carbon
14]o,p'-Dicofol on the Surface of Soil: Technical Report No. 31C-87-50.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories. 8 p.
40460105 Warren, J. (1987) Supplement to Hydrolysis of [Carbon 14]-p,p'Dicofol:
Technical Report No. 31C-87-52. Unpublished study performed by Analytical
Bio-Chemistry Laboratories. 41 p.
40504501 Rohrbach, W.; Nichols, R. (1988) Product Chemistry Section for Kelthan
Technical: Project ID No. RWN-88-008. Unpublished study prepared by Rohm
and Haas Co. 204 p.
5. (1987) Residue Aanlysis of Dairy Cow Milk and tissues for Dicofol
and Its Metabolite: Supplement [Data]: Project ID: 34827. Unpublished study
prepared by ABC Laboratories, Inc. 1805 p.
40644603 Hofmann, C.; tillman^ A; ChQng> -g (19gg) Supplement to Kelthane Residues
in Citrus, Apple, Pears,..., Cottonseed: Report No. 34C-88-35. Unpublished
study prepared by Rohm and Haas Co. 102 p.
40644604 Shaffer, S.; Dillon, K.; Bailee, D. (1988) Addendum to a Feeding Study with
Laying Hens Dosed with Technical Kellhanel'Projertn):34828 and 34829.
Unpublished study prepared by Analytical Bio-Chemistry Labs., in cooperation
with Ricerca, Inc. 1593 p.
40644605 Hofmann, C. (1987) AStudy on.the Stability of p,p'-Dicofbl and o^'-Dicofol on
Citrus in a Frozen Storage Environment: the Final Two Year Report: Report
No. 31C-87-20. Unpublished study prepared by Rohm and Haas Co. 162 p.
40644606 Martin, J. (1981) A Residue Analytical Method for Kelthane: Project ID:
XR-36F-81-05. unpujjjijs^e(j stucjy preparecj by'Rohm and Haas Co. 31 p
40644607 Hofmann, C. (1988) Final Report on the Stability of o,p-Dicofol in Cottonseed
Products Under Frozen Storage Conditions for Two Years: Report No.
' , , -| *js~
1/6
,ifiii: iiiiiiiiJ'iF ii.!' SPfiJiJj ,i,,,Si Si iff,, 'i
-------
BIBLIOGRAPHY
MRID
CITATION
40644608
40731201
40731202
40731204
40731205
40779201
40812101
40849701
40849702
34C-88-29. Unpublished study prepared by Analytical Development Corp. and
Rohm and Haas Co. 467 p.
Hofmann, C. (1987) Final Report On the Stability of p,p'Dicofol in Cottonseed
Products Under Frozen.Storage Conditions after Two Years: Report No.
31C-87-26. Unpublished study prepared by Rohm and Haas Co. 163 p.
Bonin, R.; Hazelton, G. (1987) Dicofol (Kelthane Technical Miticide): Delayed
Contact Hypersensitiviry Study in Guinea Pigs: Rept. No. 87R-027; Protocol
No. 86P-512. Unpublished study prepared by Rohm and Haas Co. 61 p.
Fisher, 1; Hagan, J. (1987) Dicofol (Kelthane Technical Miticide): Acute
. Inhalation Toxicity Study in Rats: Rept. No. 87R-001; Protocol No. 87P-001.
Unpublished study prepared by Rohm and Haas Co. 52 p.
Krzywicki, K.; Bonin, R. (1985) Acute Definitive Oral LD50 in Rats in Kelthane
. Technical.: Rept. No. 85R 034A&B. Unpublished study prepared by Rohm and
Haas Co. 16 p. - .
N
Krzywicki, K.; Bonin, R. (1985) Acute Definitive Dermal LD50 in Rats/Rabbits
in Kelthane Technical. Unpublished study prepared by Rohm and Haas Co. 22
P. ,' ' ".. - . .;' " ' . . . , _ _.. .
Miller, Y. (1988) Estimation of DDT-rs in 5 Samples of Dicofol Technical:
Supplementary Data: Laboratory Report ID S551-4/S637-3. Unpublished study
prepared by Agan Chemical Manuf. Ltd., Israel. 26 p.
Deakyne, R.; Zogorski, W. (1988) FDA Multiresidue Screen Results for p,p' and
o,p'-Dicofol: Rohm and Haas Report No. 34C-88-49. Unpublished study
prepared by Quality Control Laboratory. 206 p. , '
Carpenter, M. (1988) "Determination of the Photodegradation Rate of [carbon
14]-p,p -Dicofol in Aqueous Solution": ABC Final Report #36670. Unpublished
study prepared by Analytical Bio-chemistry Laboratories, Inc. 1292 p.
Carpenter, M. (1988) "Determination of the Photodegradation Rate of [carbon
14]-o,p'-Dicofol in Aqueous Solution": ABC Final Report #36669. Unpublished
study prepared by Analytical Bio-chemistry Laboratories, Inc. 1233 p.
177
-------
BIBLIOGRAPHY
MRID
CITATION
40944601
40944602
40944603
Larkin, R. (1988) Dicofol Residue Data for Hops7 Project ID:RHLMemo
88-129. Unpublished study prepared by Washington State Univ., and
Washington State Dept, of Agric. 28 p.
Hofman, C. (19"i88) Kelthane Residue Data for Peppers ...: Project ED: Rohm and
Haas Analytical Report No. 34A-88-46. Unpublished study prepared by Rohm
and Haas Co., in cooperation with Analytical Development Corp. 81 p.
Hofmann, C, (1986) Analytical Reports of Kelthane Miticide Residues in
Peppers: Rohm and Haas Analytical Report No. 31A-87-26. Unpublished study
prepared by Rohm and Haas Co., in cooperation with Analytical Development
Corp. 79 p.
40944604
mi in iii ii 11 in
40953701
in
Hofmann, C. (1988) Kelthane; Residue:DataforTpmatpes:ii|^|l^iii86-p381y-...J
Unpublished study prepared by Rohm and Haas Co., in cooperation with
Analytical Development Corp. 252 p.
I'-lSiiiiii'i' WKHW^TI. /ill ซซ'( .ii"s ' is;1;*.!:; >' tUti v'Kitxt s mil, v u&w; tit" SK ซii w". / ,tซ. is s; n ซcii11 r taJH
1 11111
40958001
Nelson, S. (1988) Additional Investigations on the Metabolism of [carbon
14]-p,p'-and [carbon 14]-o,p'-Dicofbl in Cotton: Project ID: Rohm and Haas
Technical Report No. 34C-88-66. Unpublished study prepared by Rohm and
Haas Co. 327 p.
Cairns, S. (1988) Supplement to DicofolNature of the Residue in Lactating
Dairy Goats: Project ID: Rohm and Haas Technical Report No. 34C-88-58.
Unpublished study prepared by Rohm and Haas Co. 200 p.
40958002
40958003
40997100
40997101
Nelson, S= (1988) Additional Investigations on the Metabolism of [carbon
14]-p,p'-Dicofol in Grapefruit: Project ID: Rohm and Haas Technical Report No.
34C-88-63. Unpublished study prepared by Rohm and Haas Co. 249 p.
Cairns, S. (1 988) Supplement to/Dicofdl-Nature of the Residue in Laying Hens:
Project ID: 34C-88-57. Unpublished study prepared by Rohm and Haas Co.
179 p.
i, ......... * . . .
Rohm and Haas Co. (1989) Submission of Data To Support Registration of
Dicofol: Toxicology Data. Transmittal of 1 study.
Tegeris, A. (1988) Dicofol (Kelthane Technical Miticide): One Year Dietary
Toxicity Study in Beagle Dogs: Final Report: Report No. 86014. Unpublished
study prepared by Tegeris Laboratories, Inc. 2094 p.
178
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-------
BIBLIOGRAPHY
MRID
CITATION
41026701
41037801
41050701
41077001
41094200
41094201
41150001
41231301
4123.1901
41231902
Manning, C. (1988) Kelthane Technical: Acute Toxicity on Shell Growth of the
Eastern Oyster (Crassostrea virginica): Report No. 88RC-0023: ESE No.
88309-0200-2130. Unpublished study prepared by Enviromental Science and
Engineering, Inc. 413 p.
U.S. Public Health Service,(1978) Bioassay of Dicofol for Possible
Carcinogenicity: NCI-CG-TR-90. Unpublished study. 86 p.
Daly, D, (1989) "Aerobic Soil Metabolism of [carbon 14-p,p'-Dicofol": Project
ID: ABC Final Report No. 36101. Unpublished study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 1822 p.
Bonin, K.; Hazelton, G.; Kulwich, B. (1986) Dicofol (Kelthane MF Miticide):
4-Week Dermal Toxicity Study in Rabbits: Report No. 86R-047: Protocol No.
. 86P-085. Unpublished study prepared by Rohm and Haas Co. 266 p.
Rohm and Haas Co. (1989) Submission of Soil Metabolism Data to Support the
Registration of Products Containing Dicofol. Transmittal of 1 study.
Tillman, A.; Daly, D. (1988) Addendum to the Aerobic Soil Metabolism of
[Carbon 14]-o,p'-Dicofol on Silt Loam Soil: Rohm and Haas Technical Report
No. 34C-88-28. Unpublished study prepared by Rohm and Haas Co. in
cooperation with Analytical Bio-chemistry Labs. 991 p.
Hazelton, G.; Harris, J. (1989) Dicofol (Kelthane Technical Miticide): 24-Month
Dietary Chronic/Oncogenic Study in Rats: Protocol No. 86P-075: Report No.
86R-190. Unpublished study'prepared by Rohm and Haas Co. 3080 p.
Beavers, J.; Marselas, G.; Jaber,, M. (1988) Dicofol (Kelthane Miticide): A One
-Generation Reproduction Study with Mallard (Anas platyrynchos) Using
Parental Incubation: Project No. 129-127; Report No. 88RC-0087. Unpublished
study prepared by Wildlife International Ltd. 373 p. '
Reibach, P. (1989) [Carbon 14]-Dicofol: Tomato Metabolism Under Field
Conditions: Project ID 34-89-35. Unpublished study prepared by Rohm and
Haas Co. 251 p.
Satterthwaite, S. (1989) Magnitude of the Residue of o,p' and p,p'Dicofol on
Oranges: Project ID 34A-89-39. Unpublished study prepared by Analytical
Development Corp. 116 p.
179
-------
BIBLIOGRAPHY
MRID
CITATION
41231903 Johnston, D. (1989) Determination of o,p'-Dicofol and p,p'-Dicofol Residues in
Cucumber Samples from RAR: 88-0256 and 88-0356: Project ID 34A-89-46.
Unpublished study prepared by Analytical Development Corp in association with
Rohm and Haas Co. 82 p.
41231904 Satterthwaite, S. (1989) Magnitude of the Residue of o,p' and p,p'Dicofol in
Lemons: Project ID 34A-89-37. Unpublished study prepared by Analytical
Development Corp. 80 p.
.4123.120.5 Satterthwaite, S. (1989) o,p'and p.p'-Dicofpl in Apples: Project ID 34A-89-22.
Unpublished study prepared by Analytical Development Corp. 56 p.
41231906
41231907
41299901
41375401
41380400
41380401
Satterthwaite, S. (1989) o,p'and p,p'-Dicofol in Cotton: Project ID 34A-89-45.
Unpublished study prepared by Analytical Development Corp. 327 p.
Satterthwaite, .ง,. (1989) o,p' and p,p'-Dicoibl in Beans: Project ID 34A-89-40.
Unpublished study prepared by Analytical Development Corp. 407 p.
' i
Kennedy, R.; Moezpoor, E. (1989) Analysis of Dicofol and Its Metabolites in
Soil: Final Report: Lab Project Number: 37534: 34-8956. Unpublished study
prepared by Analytical Bio-chemistry Laboratories, Inc. 3.78 p.
Cairns, M. (1989) Supplement to Determination of the Phdtodegradation Rate of
[Carbon14]-o,p'-Dicofol in Aqueous Solution: Lab Project Number: 34-89-66.
Unpublished study prepared by Rohm & Haas Co. 180 p.
Rohm and Haas Co. (1990) Submission of Residue Data to Support the Dicofol
Data Call-in Notice of Feb22, 1988. Transmittaj of 1 study.
Satterwhite, S. (198.9) Additional Investigations for the Analytical Report of o,p'
arid p,p'-Dicofol Residues in Beans: Supplement: Lab Project Number:
34A-89-66. Unpublished study prepared by Analytical Development Corp. 116
41381801 Bender, D.; Hofmann, C. (1990) Twelve Month Terrestrial Field Dissipation
Study of Kelthane Miticide: Lab Project ID: 34-89-28. Unpublished study
prepared by Pan-Agricultural Labs, Inc. in cooperation with Rohm and Haas
| Co., and ABC Laboratories, Inc. 777 p.
i
41480401 Tillman, A. (1990) Kelthane Residue Studies in Tea: Lab Project I.D. AMT
90-08. Unpublished study prepared by Rohm and Haas Co. 128 p.
180
-------
BIBLIOGRAPHY
MRID
CITATION
41509801
41509802
41695401
41695402
41764801
41764802
41785101
41785102
. Daly, D. (1987) Soil/Sediment Adsorption-Desorption with [Carbon
14]-p',p'-Dicof6l: Lab Project Number: 36049: 31C-87-43. Unpublished study.
prepared by Analytical Bio-Chemistry Laboratories, Inc. 509 p. ,
Warren, J. (1986) Leaching Characteristics of [Carbon 14]-o',p'-Dicofol in Four
Soil Types: Lab Project Number: 34619:310-86-40. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 290 p.
Bowman, I; Ritchie, P. (1990) Acute Flow-throguh Toxicity of Dicofol
(Kelthane Technical Miticide) to Rainbow Trout (Salmo gairdneri): Final Report:
Lab Proj ect No. 37745, 89RC-0013. Unpublished study prepared by Analytical
Bio-Chemistry Labs., Inc. 199 p.
Bowman, J. (1990) Acute Flow-Through Toxicity of Dicofol (Kelthane
Technical Miticide) to Sheepshead Minnow (Cyprinodon variegatus ): Lab
Proj ect Number: 37746: 89RC-0014. Unpublished study prepared by Analytical
Bio-Chemistry Labs, Inc. 273 p.
Lee, T.; Palmer, D.; Krueger, H. (1991) A Monitoring Study for Residues of
Dicofol, Dicofol Metabolites and DDE in Eggs of California Birds in 1989: Lab
Proj ect Number: 129-134: 89RC-111. Unpublished study prepared by Wildlife
International Ltd. 1728 p.
Gallagher, S.; Palmer, D.; Krueger, H. (1990) A Monitoring Study for Residues
of Dicofol, Dicofol Metabolite and DDE in Eggs of Florida Birds in 1989: Lab
Proj ect "Number: 129-133. Unpublished study prepared by Wildlife International
Ltd. 1774 p. ' - '
Meyer, C.; Palmer, D.; Kreuger, H. (1991) A Monitoring Study of Dicofol,
Dicofol Metabolites and DDE in Eggs of Texas Birds in 1989: Lab Project
Number: 129-135; 89RC-113. .Unpublished study prepared by Wildlife Int Ltd
1800 p. '".:.'
Wilkinson, C. (1991) Residues of Dicofol, Dicofol Metabolites and DDE in
Selected Environmental Matrices: California, 1989: Lab Proj ect Numbers:
23.7130.89.4; 38044; 1186. Unpublished Study prepared by Versar, Inc. in
coop, with ABC Labs and others. 2402 p.
181
-------
BIBLIOGRAPHY
MRID
CITATION
41785103 Wilkinson, C. (1991) Residues of Dicofol, Dicofol Metabolites and DDE in
Selected Environmental Matrices: Florida, 1989: Lab Project Numbers:
23.7130,89.5: 38130: 1186. Unpublished study preparediby Versar, Inc. in
coop, with ABC Labs, Inc. and others. 3120 p.
41806601 Solomon, H.; Kulwich, B. (1991) Dicofoi:Two-gene^ Reproduction Study
in Rats: Protocol No. 89P-028: Lab Project No. 89R^b28"'Unpublished study
prepared by Rohm and Haas Co. in assoc. with MalSteshim-Agan. 925 p.
41845601 Palmer, D.; Krueger, H. (1991) AMonitoring Study for Residues of Dicofol,
Dicofol'Metabolites and DDE inEggs of CaiifofriiaBirds'in 1990: Labi Project
Number: 90RC-134: 129-134. Unpublished Study prepared by Widlife
International Ltd. 522 p.
41845602 Lee, T.; Palmer, D.; Krueger, H.( 1991) A Monitoring Study for Residues of
Dicofol, Dicofol Metabolites and DDE in Eggs of NewYork Birds in 1990: Lab
Project Number: 90RC-011: 129.132: Unwished^dy preparedby Widlife
International Ltd. 497 p.
iJS.'"iwR'i.i'*''4l5i]5ii.O? Gflagher, S.; Palmer, D.; Krueger, H. (1991) AMonitoring Study for Residues
' *' >' ''"' |i: " ''"" ' !i' ' ?w " of Dicofol, Dicofol Metabolites and DDE in Eggs of Florida Birds in 1990: Lab
PfojeclNumber: 90RC-6i2Ti2^
International Ltd, 490 p.
41845604 Wilkinson, C. (1991) Residues of Dicofol, Dicofol Metabolites and DDE in
Selected Environment Matrices: New York, 1990: Lab Project Number:
O: 3^1 Unpublished study prepared by Widlife
'. "& Huntingdon Analytical servjceg |nc; 4433"^.
41845605 Wilkinson, C. (1991) Residues of Dicofol, Dicofol Metabolites and DDE in
Selected Environment Matrices: Florida, 1990: Lab Project Number:
23.7130.90.6: 90RC-015: 38571. UnpubHshed stady prepared by W^
International Ltd. & Analytical Development Corp. 4357 p.
41857301 Wilkinson, C. (1991) Residues of'Dicofol, Dicofol Metabolites and DDE in
Selected Environmental Matrices: California, 1990: Lab Project Number:
90RC-013: 23.7130:90.4: 38570. Unpublished Study prepared by ABC
Laboratories, Inc., Analytical Development Corp. and others. 4095 p.
41934001 Clark, D.; Spann, I; Bunck, C. (1990) Difocal (Kelathane)-Induced Eggshell
Thinning in Captive American Kestrals. Env. Tox. and Chem. 9:1063-1069.
182,
-------
BIBLIOGRAPHY
MRID
CITATION
41985701
Milligan, D. (1991) Dicofol (Kelthane Technical Miticide): Acute Flow-through
Toxicity of Dicofol(...) to Rainbow Trout (Salmo gairdneri). .Supplement to
MRID 41695401: Lab Project Number: 89RC-OOI3A. Unpublished study
prepared by Rohm & Haas Co. 10 p.
42003501
42003502
42003503
42000601 McAllister, W. (1991) Early Life Stage Toxicity of Dicofol (Kelthane Technical
Miticide) to Rainbow Trout (Oncorhynchus mykiss) in a Flow-through System:
Final Report: Lab Project No: 3633: 88RC/0064. Unpublished study prepared
by ABC Laboratories, Inc.'58 p.
Milligan, D.; Hurt, S. (1987) Supplement to the Dicofol (Kelthane- Technical
Miticide): A One-Generation Reproduction Study with the Bobwhite (Colinus
virginianus): Lab Project Number: TD 87M1234: 86RC-0047. Unpublished
study prepared by Rohm and Haas Co. 9 p.
Milligan, D.; Hurt, S. (1987) Supplement to the Dicofol (Kelthane Technical ,
Miticide): Acute Toxicity of Kelthane Technical to Daphnia Magna: Lab Project
Number: TD 87M-1244: 85RC-0014. Unpublished study prepared by Rohm and
Haas Co. 8 p.
Milligan, D.; Hurt, S. (1987) Supplement to the Dicofol (Kelthane Technical
Miticide): Acute Toxicity of Kelthane Technical to Mysid Shrimp (Mysidopsis
bahia): Lab Project Number: TD 87M-1246 85RC-0046. Unpublished study
. prepared by Rohm and Haas Co. 7p ,..-
42063001 McAllister, W. (1991) Supplemental Report to MRID 42000601: Early
Life-Stage Toxicity of Dicofol (Kelthane Technical Miticide)to Rainbow Trout
(Oncorhynchus mykiss) in a Flow-through System: Lab Project Number: 36337:
88RC-0064A. Unpublished study prepared by ABC Labs, Inc. 762 p.
42091501 Wilkinson, C. (1991) Supplemental Report to Residues of Dicofol Metabolites
- and DDE in Selected Environmental Matrices: Florida 1989: Lab Project
Number: 129-136: 3904099-0202: 91TR-1. Unpublished study prepared by
Wildlife International Ltd. and ESE Labs. 438 p.
421.18601 Bender, D. (1991) A Terrestrial Field Dissipation Study of Kelthane Miticide in
Thermal, CA: Lab Project Number: 34-91-53. Unpublished study prepared by
Rohm and Haas Co.; ABC Labs., Inc., and Others. 1100 p.
183
-------
BIBLIOGRAPHY
MRID
CITATION
42151101
42160401
42214701
42268701
42276101
42276102
'ill11' '
42285501
42285502
42285503
Gordon, E.; David, B.; Shaffer, S. (1991) Magnitude of the Residue: Dicofol
Residues in Black Tea Leaves, Brewed Tea, and Instant Tea: Interim Report:
Lab Project Number: MAA-91C. Unpublished study prepared by
Makhteshim-Agan (America), Inc. 3 p.
Tillman, A. (1990) Dicofol Residue Studies in Hops: Lab Project Number: AMT
90-40, Unpublished study prepared by Washington State University, State of
Washington and Rohm and Haas Co. 85 p.
\ "* Si''1 '< "'" i
-, - , .. , , , , , , , -
Tillman, A. ?199l5 Dicofol Tea Residue Studies from Japan: Final Report: Lab
I IIIIIMlll^^ ....... || ...... ..... , ,- ...... nil ........... ,,,,,' ............. , ...................... ซ ...... ........ ............ in- ....... .......... ..... , ..... n ,n|,,, ..... .............. , ..... im ....... ,, ..... ,,,,, ................................. ...... | ..... , ..... if ...... ........... | ...... ...... jiiyi ,i ....... ป ..... ป ...... , ,,ป ป ,ป: ..... ........ .............. ............. ........ , ..... , . , iv, ,1,711 ...... , ,;ii ........... M ...... , ,
Project Number: AMT 91-125. Unpublished study prepared by Mie
Agrochemical and Tea Technical Center; Kagoshima Tea Experimental Station
and Tocil Analytical Lab. 52 p. . '
O'Connor, H. (1992) Supplementary Data on the Residues of Dicofol, its
Metabolites and DDT-Related Materials in Carcasses and Eggs of Female
American Kestrels Fed Diets Containing Dicofol: Lab Project Number:
89RN-1005A. Unpublished study prepared by U.S. Fish and Wildlife Service.
14 p. .................................. ' .................. ..... , ........... ' ' ;":; ...... ' ......................................... M '" "
Bender, D. (1992) Arguments in Support of Supplement to Dicofol-Nature of
the Residue in Laying Hens MRID #40958003 : Lab Project Number: 34-92-3 1 .
Unpublished study prepared by Rohm and Haas Comp. 37 p.
Bender, D. (1992) Arguments in Support of Supplement to Dicofol-Nature of
the Residue in Lactating Dairy Goats MRID #40958001: Lab Project Number:
34-92-33. Unpublished study prepared by Rohm and Haas Company. 14 p.
1 nil I i|l 1 1 ......... im 1 1 in i n i n I n i 111 ......... ill ill i i I In i i ! i i
Wilkinson, C. (1992) Residues of Dicofol, Dicofol Metabolites and DDE in
Selected Environmental Matrices: New York, 1991 : Lab Project Number:
91TR-6: 90RC-271: 39478. Unpublished study prepared by ABC Labs,
Analytical Development Corp., Huntingdon Analytical Services and Wildlife
International Ltd, 2941 p.
Gallagher, S.; Palmer, D.; Krueger, H. (1992) A Monitoring Study for Residues
of Dicofol, Dicofol Metabolites and DDE in Eggs of New York Birds in 1991:
Lab Project Number: 90RC-270. Unpublished study prepared by Wildlife
International Ltd. 429 p.
/ ' , '' ,
Wilkinson, C. (1992) Residues of Dicofol, Dicofol Metabolites and DDE in
Selected Environmental Matrices: California, 1991: Lab Project Number:
184
i mi
! Ill
-------
BIBLIOGRAPHY
MRID
CITATION
91TR-5: 90RC-273: 39473. Unpublished study prepared by ABC Labs,
Analytical Development Corp., Huntingdon Analytical Services and Wildlife
International Ltd. 2732 p. .
42285504 Gallagher, S.; Palmer, D.; Krueger, H. (1992) A Monitoring Study for Residues
of Dicofol, Dicofol Metabolites and DDE in Eggs of California Birds in 1991:
Lab Project Number: 129-134: 90RC-272. Unpublished study prepared by ,
Wildlife International Ltd. 688 p.
42285505 Gallagher, S.; Palmer, D.; Krueger, H. (1992) A Monitoring Study for Residues
of Dicofol, Dicofol Metabolites and DDE in Eggs of Florida Birds in 1991: Lab ,
Project Number: 129-133: 90RC-274. Unpublished study prepared by Wildlife
, International Ltd. 421 p.
s . '. '
42297201 Hofman, C. (1992) Dicofol Residue Data for Beans: Lab Project Number:
. 34A-88-74. Unpublished study prepared by Analytical Develop. Corp.; NY
State Ag. Ex. Station; Oregon State Univ., Agstat, Niel Phillips and Hulst
Research Farm Serv. in coop, with Rohm & Haas Co. 328 p.
42428001 Gordon, E.; Williams, M.; David, B. (1992) Magnitude of the Residue: Dicofol
Residues in Black and Green Tea Leaves, Brewed Tea, and Instant Tea: Lab
, Project Number: MAA-91-C. Unpublished study prepared by Makhteshim-Agan
of North America, Inc. 128 p.
42437301 Wilkinson, C. (1992) Residues of Dicofol, Dicofol Metabolites and DDE in
Selected Environmental Matrices: Florida, 1991: Lab Project Number:
90RC-275: 91TR-7. Unpublished study prepared by Technology Services
Group. 3385 p.
42468201 Reinert, K. (1992) Supplement to the Acute Flow-through Toxicity of Dicofol
(Kelthane Technical Miticide) to Rainbow Trout (Salmo gairdneri): MRID
41695401 & 41985701: Lab Project Number: 89RC-013B. Unpublished study
prepared by Rohm and Haas Co. 14 p.
42468202 Reinert, K. (1992) Supplement to the Early Life Stage Toxicity of Dicofol
(Kelthane Technical Miticide) to Rainbow Trout in a Flow-through System:
MRID 42000601 and 42063001: Lab Project Number: 88RC-0064B.
Unpublished study prepared by Rohm and Haas Co. 10 p.
185
-------
BIBLIOGRAPHY
MRID CITATION
42514801 Batra, R. (1992) Addendum to Product Chemistry of Kelthane Technical (MRID
40504501): Lab Project Number: APR/SH-92-197. Unpublished study prepared
by Rohm and Haas Co. 100 p.
42514802 Martin, J. (1992) An Analytical Method for Kelthane and Related Compounds in
Citrus Fruit and Citrus Fruit Products: Lab Project Number: 31L-83-10.
Unpublished study prepared by Rohm and Haas Co. 75 p.
42514803 Bender, D. (1992) Response to September 30, 1991 EPA Data Call-in for
Dicofol Residue Analytical Method: Plant: Lab Proj ect Number: 34-92-76.
Unpublished study prepared by Rohm and Haas Co. 23 p.
42514804 Long jr(l"992)'o, ฃ' and p, p'-Dicofpl"Residue in Peach Fruit: Lab Project
Number: 34A-92-Of. Unpublished study prepared by Analytical Development
1 Corp. anTR\>hm 2^ ||aas QO" 109 p-
42514805 Long, J. (1992) o, p1 and p, p'-Dicofol Residue in Plum and Prune Fruit: Lab
Proj ect Number: 34A-92-04. Unpublished study prepared by Analytical
! Development Corp. 184 p.
42514806 Long, J. (1992) o, p1 and p, p'-Dicofol Residue in Cherry Fruit: Lab Project
Number: 34A-92-01. Unpublished study prepared by Analytical Development
Corp. 209 p.
42611901 Gordon, "R; Williams, M; David, Brp992)"iifagnitude of the Residue: Dicofol
Residues in Black and Green Tea Leaves, Brewed Tea, and Instant Tea:
Amendrneh'f'Sl to Final ReportTfab Pfbject"Number: MAA-i9'i-C.' Unpublished"
study prepared by Makhteshim-Agan of North America, Inc. in coop with
Horizon Labs Inc. and Coromandel Indag Products j^dia Ltd. 9 p.
42628901 Ritchie, P.; Stuerman, L.; Rhodes, J.; et al. (1992) Full Life-cycle Toxicity Study
of Dicofbl p^githane 'technical Mticide) to Faliead Minnows (Pimephales
prdmelas) in a Flow-through System: Lab Proj ect Number: 36338: 91RC-1006.
liil^IIIIIPIIilllllllillJlLWitl"! lil'IJl'l '' ' ' ซ >' ป" ' .Ki, T" "i.i.S , ! " ,;,"! ..;:T < <<;< : - < < ,,, , , ,
Unpublished study prepared by ABC Labs, Inc. 750 p.
ii
ii
42633300 Rohm and Haas Co. (1993) Submission of toxicity data in support of the
registration standard for Dicofol. Transfnittal of 3 studies .
186
-------
BIBLIOGRAPHY
MRID
CITATION
42633301 Batra, R. (1992) Addendum to Kelthane Technical B Product Chemistry Series
61: Product Identity and Composition: Lab Chemistry Numbr Chemistry Series
61: Lab Project Number: APR/SH-92-198. Unpublished study prepared by
Rohm and Haas Co. 26 p.
42633302 - Verona, D. (1992) Product Chemistry. Series 62 Analysis and Certification of
Product Ingredients in Kelthane Technical B: Lab Project Number:
,, . APR/SH-92-270. Unpublished study prepared by Rohm and Haas Co. 218 p.
42633303 Foss, J. (1992) Acute Neurotoxicity Study of Dicofol (Kelthane Technical B
Miticide) Administered Orally Via Gavage to Crl:CDBR VAF/Plus Rats: Final
Report: Lab Project Number: 018-017: 92P-005. Unpublished study prepared
by Argus Research Labs., Inc. 1057 p.
42721301 Wilkinson, C. (1993) Residues of Dicofol, Dicofol Metabolites and DDE in
. Selected Environmental Matrices: New York, 1992: Lab Project Number:
92TR-4: 92RC-007: 40368. Unpublished study prepared by ABC Labs, Inc.,
Analytical Development Corp., Huntingdon Analytical Services and Wildlife
International Ltd. 3042 p.
Gallagher, S.; McAllister, S.; Palmer, D.; et al. (1993) A Monitoring Study for
Residues of Dicofol, Dicofol Metabolites and DDE in Eggs of New York Birds
in 1992: Lab Project Number: 129-132: 92RC-008. Unpublished study prepared
by Wildlife International Ltd. 561 p.
O'Neill, P. (1993) Supplement to the Kelthane Technical Microbial Mutagen
Assay: Lab Project Numbe'r: 85R-0042A: 85R-0042. Unpublished study
prepared by Rohm and Haas Co. 56 p.
Foss, J. (1993) Subchronic Neurotoxicity Study of Dicofol (Kelthane Technical
, B Miticide) Administered Orally via the Diet to Crl:CD BR VAF/Plus Rats: Lab
Proj ect Number: 018-018: 92RC-004: 92P-004. Unpublished study prepared by
Argus Research Laboratories, Inc. 991 p.
' - *
42971402 Bender, D. (1993) Characterization of Bound Residues in Peel of Grapefruit '.
Treated with (Carbon 14)-p,p'-Dicofol: Lab Proj ect Number: 34-93-92.
Unpublished study prepared by Rohm and Haas Company. 249 p.
42721302
42852401
42971401
187
-------
BIBLIOGRAPHY
MRID
CITATION
42971403 Hoffmann, C. (1993) Storage Stability Study: p,p;-Dicofol and o^'-Dicofbl in
Apples, String Beans, Honeydew Melon, Green Peppers and Strawberries (One
Year Report): Lab Project Number: 34P-92-24: 34-93-83. Unpublished study
prepared by Rohm and Haas Company. 150 p.
42971404 TiMman' A/ (1993) Response to EPA Review on the Feeding Study and Storage
Stability Study of Laying Hen Egg and Tissues for Dicofol and Its Metabolites:
Supplemental Report to MRID# 40042031 and MRID # 40644604.
Unpublished study prepared by Rohm and Haas Company. 45 p.
42971405
42971406
42971407
42971408
42971409
42971410
Tillman, A. (1993) Response to EPA Review on the Feeding Study and Storage
Stability Study of Dairy Cow Milk and Tissues for Dicofol and Its Metabolites:
Supplemental Report to MRID# 40042030 and MRID # 40644601: Lab Project
Number: 34-92-77. Unpublished study prepared by Rohm and Haas Company.
39 p.
Miller, S. (1993) Arguments in Support of Analytical Report of o,p'-and
p,p'-Dicofol Residues in Cotton Samples: Rohm and Haas Technical Report
34A-89-45: MRID No. 41231906: Labi Project Number: 34-93-84. Unpublished
study prepared by Rohm and Haas Company, lip.
: , ih ' ::,! :: ,
Bender, D.; Long, J. (1993) O,p'-and p,p'-Dicofol Residues in Lima Beans: Lab
Proj. No. 34A-93-08. Unpublished study prepared by Rohm and Haas Co. and
Analytical Development Corp. 287 p.
Bender, D. (1993) Arguments in Support of Dicofol Residues for Beans: Rohm
and Haas Technical Report 34A-88-74: MRID # 42297201: Lab Project
Number: 34-93-68. Unpublished study prepared by Rohm and Haas Company.
6 p.
Brackett, C. (1993) Arguments in Support of "Dicofol Residue Studies in
Hops": Rohm and Haas ID-AMT 90-40: MRID No. 42160401: Lab Project
Number: 34-93-93." Unpublished study prepared "by "Rohm and Haas Company
32 p. '''""' "' ' "" ' :" .""" "" ' " "" '""" ; ""="1"" ""
Miller. S. (1993) Determination of Kelthane MF Residue Levels in Cotton
II Hill ? N ., /.. ., ,,! ,,,, j ^ || ||
Process Components: Lab Project Number: 34-93-78. Unpublished study
prepared by Rohm 3^ f|aas Company; Analytical Development Corp.;
Engineering Biosciences Research Center-Texas A&M Univ. 237 p.
188
'it,, 17HIซi,iiiiniii lO", \ ,iin niluiii::,, * ivn\ v :n;: i mini,:: 1,1. if\ . ; .in," "!.ซir"i fl\ \><,!ป ป1,1 f ,J" ki: n i. <<:.
-------
BIBLIOGRAPHY
MRID
CITATION
42975101
42975102
42971411 Bender, D.; Hofmann, C. (1993) A Tomato Processing Study of Tomatoes
Treated with KelthaneMF: Lab Project Number: 34-93-03. Unpublished study
prepared by Rohm and Haas Company; Analytical Development Corp.; National
Food Laboratory. 256 p.
Satterthwaite, S. (1990) O,p' and p,p'-Dicofol in Peaches: Lab Project Number:
34A-90-26: AR34A-90-26. Unpublished study prepared by Analytical
Development Corporation. 169 p.
Schwarzbach, S.; Shull, L.; Grau, C. (1988) Eggshell thinning in ring doves
exposed to p,p'-dicofol, Arch. Envir. Contam. Toxicol. 17:219-227. Project
No. 93R-1044. Prepared by Univ. of Calif., Dept. of Avian Sciences, Dept. of
Envir. Toxicology.
42975103 Schwarzbach, S.; Fry, D.;Rossen,B. etal. (1991) Metabolism and storage of
p,p'dicofol in American kestrels (Falco sparverius) with comparisons to Ring
,' Neck Doves (Streptopelia risoria). Arch. Envir. Contam. ToxicoL 20:206-210.
Project no. 93R-1043. '
Schwarzbach, S. (1993) The role of dicpfol metabolites in the eggshell thinning
response of ring .neck doves. Arch. Envir. Contam. Toxicol. 20:200-205. Lab
Project No. 93R-1045;' '
V .-,.. ; .
Meyer, A. (1993) Interim Results for Guideline Series 63-17 (Stability) and
63-20 (Corrosion Characteristics) for Kelthane Technical B: Lab Project
Number: APR/SH-93-294: 894660-7: 73P-93-35. Unpublished study prepared
by Rohm and Haas Co. 69 p.
Hurt, S. (1993) Response to the Data Evaluation Report of 9/17/91 Concerning
the Acceptability of the Kelthane in vivo Cytogenetic Study in Rats: Supplement
,-to MRID;No. 400420-50: Lab Project Number: 8;5R-215A:93P-227:
93R-227A. Unpublished study prepared by Rohm and Haas Co. 37 p.
43070103 Steigerwalt, R.; Deckert, F.; Longacre, S. (1993) Comparative Disposition of a
Single po Dose of (carbon-14)-Kelthane and (carbon-14)-DDT in Rats:
Reformatted Final Report: Lab Project Number: 79R-130: 79R-130A: 79P-115.
Unpublished study prepared by Rohm and Haas Co. 57 p.
.42975104
43070101
43070102
189
-------
BIBLIOGRAPHY
MRID
CITATION
43070104 Steigerwalt, R.; Deckert, F.; Longacre, S. (1993) Comparative Disposition of
Multiple Doses of (carbon- 14)-Kelthane and (carbon-14)-DDT in Female Rats:
SefojmaagdFinil Report: Lab Project Number: 80R-174: 79P-503: 80R-174A.
Unpublished study prepared by Rohm and Haas Co. 132 p.
43070105 DiDonato, L.; Steigerwalt, R.; Longacre, S. (1987) o,p'-Dicofol and
p,p'-Dicofol: Kinetic Study in Female Rats: Final Report: Lab Project Number:
86P-206: 86R-173. Unpublished study prepared by Rohm and Haas Co. 75 p.
" ' '"''', * ' '
43070106 Miller, S. (1993)^gumentsm
(carbon-14)-p,p'-bicofoi on Silt Loam Soil: Lab Project Number: 34-93-108.
Unpublished study prepared by Rohm and Haas Co. 6 p.
43127501 Adams, W. (1994) Supplement to the Early Life Stage Toxicity of Dicofol
(Kelthane Technical Miticide) to Rainbow Trout in a Flow-Through System
(R&H 88 RC-0064; MRDD NO. 420006-01, 420630-01, and 424682-02): Lab
Project Nos. 41451, 88 RC-064C. Unpublished study prepared by ABC
Laboratories, Inc. 18 p.
4314650! Bender, D. (1994) Additional Data in Supportof';An.Analytical Method for
Kelthane and Related Compounds in Citrus Fruit and Citrus Fruit Products: Lab
Project Number: 34-94-16: 31L-83-10. Unpublished study prepared by Rohm
and Haas Co. 8 p. , " '.
43146502 Bender, D. (1993) o,p'and p,p'-Dicofol Residues in Apple Fruit: Lab Project
Number: 34A-93-05: 1212-7. Unpublished study prepared by Rohm and Hass
Co. and Analytical Development Corp. 112 p.
43146503 Bender, D. (1994) Additional Data in Support of o,p'-and p,p'-Dicofol Residues
in Peach Fruit: Lab Project Number: 34-94-20: 34A-92-08. Unpublished study
prepared by Rohm and Haas Co. 6 p.
in ii in INI i 111111 iii i MI ill lull ii in MI uniii 11 nil in i ji' ii i i i i i i i i HI n r i i i ' i i i i i i
43146504 Bender, D. (1994) Additional Data in Support of o,p'-and p,p'-Dicofol Residues
in Cherry Fruit: Lab Project Number: 34-94-18: 34A-92-01. Unpublished study
prepared by Rohm and Haas Co. 6 p. , ..
43146505 Bender, D. (1994) Additional Data in Support of o,p'-and p,p'-Dicofol Residues
in Plum and Prune Fruit: Lab Project Number: 34-94-19: 34A-93-04.
Unpublished study prepared by Rohm and Haas Co. 6 p. ' ' ,
:: ;;.::,: ; :--;;..;, :: ; ,:; ; , ,; :.;.-..:.:.;..;.:..:: -.; ;; ; 190 ' ' :..' '., .' : ' '..: ,'. ,-:
"' i , n ' 1 ' ' i
:V!!!!!!!!!!!!ll!!
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BIBLIOGRAPHY
MRID
CITATION
43146506
43162001
43182601
43227801
43227802
43227803
43383901
43383902
43383903
Bemacki, H. (1994) Dicofol (Kelthane Technical Miticide): Delayed Contact
Hypersensitivity Study in Guinea Pigs: Supplement: Lab Project Number:
87R-027A: 87R-027, Unpublished study prepared by Rohm and Haas
Toxicology Dept 7 p. ,
McAllister, W. (1994) Supplement to the Full Life-Cycle Toxicity Study of ,
Dicofol (Kelthane Technical Miticide) to Fathead Minnows in a Flow-Through
System: Lab Project Number: 91RC/1006A: 36338A. Unpublished study
prepared by ABC Laboratories, Inc. 95 p.
Bender, D. (1994) Arguments in Support of Supplement to Determination of the
Photodegradation Rate of (carbon 14)-o,p'-Dicofol in Aqueous Solution: Lab
Project Number: 34-94-30: 34-89-66. Unpublished study prepared by Rohm and
Haas Co. 8 p.
Brookman, D.; Miller, S. (1992) Storage Stability Study for Dicofol and Dicofol
Metabolites in Soil: Lab Project Number: 369344: 34-92-75: 92TR-5.
Unpublished study prepared by ABC Labs., Inc. 594 p.
Hawkins, D.; Bender, D. (1994) Terrestrial Field Dissipation Study of Kelthane
Miticide: Supplemental Report: Lab Project Number: 34-94-01: 34-89-28.
Unpublished study prepared by Pan-Agricultural Labs., Inc. and ABC Labs., Inc
630 p. . '
Bender, D. (1994) Additional Data in Support of o,p'-and p,p'-Dicofol in
Peaches: Lab Project Number: 34-94-54. Unpublished study. 6 p.
Meyer, A. (1994) Guidelines Series 63-17 (Stability) and 63-20 (Corrosion
Characteristics) for Kelthane Technical B: Supplement to MRID No: 43070101
(No. (APR)SH-93-294): Lab Project Number: APR-94-335: 73P-93-35.
Unpublished study prepared by Rohm and Haas Co. and KTA-Tator, Inc. 88 p.
Rhodes, J.; Downing, 1; Stuerman, L. (1994) Early Life-stage Toxicity of
Dicofol (Kelthane Technical Miticide) to the Rainbow Trout (Oncorhynchus
mykiss) Under Flow-through Conditions: Lab Proj ect Number: 413 82:
93RC-0280: 93P-280. Unpublished study prepared by ABC Labs, Inc. 1134 p.
Swenson, R.; Hazelton, G.. (1994) Distribution of (carbon 14)-p,p'-Dicofol to the
Bone Marrow of Rats: Amended Final Report: Supplement to "Dicofol
: 191
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BIBLIOGRAPHY
MRID
CITATION
(Kelthane Technical Miticide): In vivo Cytogenetic Study in Rats, Report Nos.
|(||||| ! ( ||f| SSR-glS^and 8jR-215J;fL^
Unpublished study prepared by Rohm and Haas Co. 40 p.
43383904 Hoffmann, C.; OTJonnell, A. (1994) Storage Stability Study: p,p'-Dicofol and
6,0-Dicofol in Apples, String Beans, Honeydew Melon, Green Peppers, and
Strawberries: Lab Project Number: 34-94-115: TR 34-94-115: 34P-92-24.
Unpublished study prepared by Rohm and Haas Co. and QC, Inc. 272 p.
43529901 Dorschner, K. (1995) Dicofol: Magnitude of the Residue on Cranberries: Lab
Project Number: 4102: 4102.91-OR18; 4103.90-WA03. Unpublished study
prepared by Interregional Research Project No. 4. 217 p.
43752801 Batra, R. (1995) o,p' and p,p'-Dicofol Residues in Strawberries: Lab Project
Number: TR 34-95-99: 94-0090: 94-0102, Unpublished study prepared by QC,
Inc, and Plant Sciences, Inc. 435 p.
43847601 Burnett, T.; Obrist, J.; Crabtree, K. (1995) Dicofol: Confined Accumulation
Study in Rotational Crops: In-Life and Total Radioactive Residue (TRR) Phase
Report: Lab Project Number: TR34-95-94: 94395: 34P-94-39. Unpublished
studyprepare3^^^ 142p. ' ' '
43908701 Hoffman, S. (1996) Anaerobic Soil Metabolism of (Carbon 14)-o,p'-Dicofol: Lab
Project Number: XBL95002: RPT00260: 34-95-198. Unpublished study
prepared by XenoBiotic Labs, Inc. 115 p.
43908702 Xu, B. [1996) fodependentLabฃra.tory Method Trials of the Residue Analytical
Method for Dicofol and FW-I52 in Milk, Eggs, Muscle, Liver, Kidney, and Fat:
Lab Project Number: 002-162: '34P-95-66: TR 34^95-211. Unpublished study
prepared by Centre Analytical Labs, Inc. 149 p.
i i
43908703 Goodnpugh, D.; Bruns, G. (1995) Independent Laboratory Method Trials of a
Residue Analytical Method for p,p'-Dicofpl and o,p'-Dicofol in Crops: Lab
Project Number: 34P-95-67: 3105.24i iraODOlEP.Unpublished study
prepared by Enviro-Test Labs. 166 p.
43908704 Hofmann, C. (1995) A Residue Analytical Method for p,p'-picofol and
o,p'-Dicofol in Crops: Lab Project Number: 3T94-134:'"tR34-94-134^
Unpublished study prepared by Analytical Development Corp. and Q.C. Labs.
72 p. " '
192
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BIBLIOGRAPHY
MRID
CITATION
43908705
43958701
44099201
44099202
44253801
44552801
44624300
44624301
44636501
Wedekind, W. (1995) Method of Analysis of o,p'-Isomers and p,p'-Isomers of
Dicofol and FW 152 in Milk, Eggs, Muscley Liver, Kidney and Fat: Lab Project
Number: 34-95-72: TR 34-95-72. Unpublished study prepared by ABC Labs,
Inc: 53 p.
Larson, I; Obrist, J. (1996) Dicofol; Confined Accumulation Study on
Rotational Crops: (Final Report): Lab. Proj ect Number: 943 95: 34-95-210:
TR34-95-210. Unpublished study prepared by ABC Labs California and Rohm
. and Haas Co. 401 p.
Lampe, K.; Baldwin, R. (1990) Dicofol (Kelthane MF-B Miticide): Four Week
Dermal Toxicity Study in Rats: Lab Project Number: 89P-085: 89R-085.
Unpublished study prepared by Rohm and Haas Co. 286 p.
DiDonato, L.; Hazelton, G (1991) (Carbon 14)-Dicofol (Kelthane MF-B
Miticide): in vivo Dermal Absorption Study of the (carbon 14)-p,p.'-Isomer in
Female Rats-: Lab Proj ect Number: 89P-144: 89R-144. Unpublished study
prepared by Rohm and Haas Co. 42 p.
f -. ' ,- i
Hoberman, A. (1997) Reproduction and Postnatal Study of Potential Endocrine
Effects of Dicofol Administered Orally (Diet) to Rats: Final Report: Lab Project
Number: 95P-119: 95RC-119: 018-021. Unpublished study prepared by Argus
Research Laboratories, Inc. 1062 p.
Bender, D.; Gaughan, R.; Hurt, S. et al. (1998) Comments on the Revised HED
Chapter of Reregistration Eligibility Decision Document for Dicofol, January 26,
1998: Lab Proj ect Number: 98R-1039: 98R-1008: 98R-1014. Unpublished
study prepared by Rohm and Haas Company. 557 p.
Rohm and Haas Co. (1998) Submission of Toxicity Data in Support of the
Reregistration of Dicofol. Transmittal of 1 Study.
Lomax, L. (1998) Ovary Follicle Counts: Supplement to Reproduction and
Postnatal Study of Potential Endocrine Effects of Dicofol Administered Orally
(Diet) to Rats: Lab Proj ect Number: 95RC-119: 018-021: R & H 95RC-119 A.
Unpublished study prepared by Pathology Associates International 14 p.
Quinn, D.; Bender, D.; Carpenter, D. '(19^8) Consumer Risk Assessment for
Acute Dietary Exposure to Dicofol Kelthane Technical Miticide) Using
Complete Distributions of Field Trial Residues for Raw Agricultural
193
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BIBLIOGRAPHY
MRID CITATION
Commodities: Lab Project Number: 98R-1080: TR34-97-87: TR34-98-120.
Unpublished study prepared by Rohm and Haas. 205 p.
Additional references:
Schwarzbach, S.E., L. Shull, and C.R. Grau. 1988. Eggshell thinning in Ring
doves exposed to p,p'-dicofol. Archives of Environmental Contamination and
Toxicology 17:219-227.
Wiemeyer, S.N., J.W. Spann, C.M. Bunck, and AJ. Krynitsky. 1989. Effects of
Kelthane on reproduction of captive eastern screech-owls. Environmental
toxicology and chemistry 8: 903-913.
256589a Bonin, R., 1995. Acute Eye Irritation, Definitive, Rabbits. Study No. 85R0004.
Unpublished study prepared and submitted by Rohm and Haas Co. (No MRID
Number.)
256589b Bonin, R., 1995. Acute Skin Irritation, Definitive, Rabbits. Study No.
85R0004. Unpublished study prepared and submitted by Rohm and Haas Co.
(No MRID Number.)
2^5330 Tillman, A. M. 1986. The bioconcentration, elimination and metabolism of
14C-dicofol by bluegill sunfish (Lepomis microchirus). Report No. 310-86-17,
prepared and submitted by Rohm and Haas Company, Philadelphia, PA
160000 Hudson, R.H., Tucker, R.K, and Haegele, M. A. (1984). Handbook of Toxicity
of Pesticides to Wildlife. USDI Publication 153, Wash., D.C
111 III I I III 111 II III II I II Mil7 !| :'"' ' ' '"'' 'ป ' "' ' ' ' ' '" !' " ' HI ' ' ' '*' "'' .:ป" ปป,
JP Q5.0.P.1991 Stevenson, J.H. 1978. The acute tpxicity of unformulated pesticides to worker
honey bees (Aphis mellifera L). Plant Pathol. 27(1):38-40.
I I I d J I I I III II III I I II III Ill| I II If!I
GS 0021002 Krzeminski, S.F. 1972. Leaching and metabolism of p,p'-Kelthane in various
soil types. Unpublished study prepared by Rohm and Haas Co., Philadelphia,
PA. Lab, 23 Tech. Report No. 23-72-4.???
,' ; ,',, ","; I. 'ซ !!!,;,,;, , ,, ; :: ,;, ' ,,, ,
GS 0021003 Schoettger, R. 1967. The acute toxicity of Kelthane to channel catfish.
Unpublished toxicity data. Columbia National Fisheries Research Laboratory.
Columbia, Missouri.
194
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BIBLIOGRAPHY
MRID CITATION
GS 0021004
GS 0021007 '
GS 0021018
Schbettger, R. 1966. The acute toxicity of Kelthane to bluegill sunfish.
Unpublished toxicity data. Columbia National Fisheries Research Laboratory.
Columbia, Missouri. ,
Hill,-E.F., Heath, R.G., Spann J.W., and ID. Williams (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds. By USFWS, Patuxent Wildlife
Research Center. Wash., D.C. USFWS (Special Scientific Report-Wildlife No
191).
Spehar, R.L., D.K. Tanner, and J.H. Gibson. 1982. Effects of Kelthane and
pydrin on early life stages of fathead minnows (Pimephales promelas) and
amphipods (Hyalella azteca). Pages 234-244 in J. G, Pearson, R. B. Foster and
W. E. Bishop, eds; Aquatic toxicology and hazard assessment. Proc. of the 5th
Annual Symposium, Amen Soc. for Testing and Materials, Phila., Pa., Spec
Tech. Publ. 766. " .-
f RID 470158014
Goldman, P.R., Bernacki, H.J., and Quinn, D.L. (1986) Kelthane: Three
month dietary toxicity study in rats. Rohm and Haas Co.; Lab. Report
No. 85R-093. Feb. 21, 1986. Unpublished,
195
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II I 1111 III I I ซ
196
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I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
? WASHINGTON, D.C. 20460
OFFICE OF
. PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-in Chemical Status
Sheet, to submit certain 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 HI below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. , Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3 (for both generic and product specific data), the Requirements Status
and Registrant's Response Form, (see section ffl-B); or,
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section HI-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
^product(s) subject to this Notice will be subject to, suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-in Response Forms. Also included is a list of all
registrants who were' sent this Notice (Attachment 5).
The/authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide,
Fungicide and Rodenticide Act as amended (FIFRA), 1 U.S.C. section 136a(c)(2)(B). Collection
of this
197
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!(^^
~, . .i' ...i. ..
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II-B. SCHEDULE FOR SUBMISSION OF DATA , -
You are required to submit the data or otherwise satisfy the data requirements specified in
the Requirements Status and Registrant's Response Forms (Insert B) within the time frames
provided. -.',"
II-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 Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161 (Telephone number:
703-605-6000). < .
'/ _ ;
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 with 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].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcV2VB) NOTICES
ISSUED BY THE AGENCY c
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-Infe! 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
You must use the correct forms and instructions" when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is specified
in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
199
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III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and 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
Nฐtice 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 Section IV-A and IV-B.
III-B, OPTIONS FOR RESPONDING TO THE AGENCY
' " ' ' ) ' i ,
1. Generic Data Reuirements
The options for responding to this Notice for generic data requirements are: (a) voluntary
cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy the generic
data requirements imposed by this Notice or (e) request a data waiver(s).
..... DIM, IIRM'AH ..... vw :, 'ii,,i",i,.,"'iii'in, ''fi^TiiiniJiiin, IPII-KTI''.. :iT\r : : iiihiiin , in,"!'!,* ....... iiiiihi/ii^jrimM^ ,ii *,x r ;;;,,. i<.|ii,: ..... iiiifiiiir1"; '/TI/H; ......... i M iit',ji , ":n i, a,;;)!11' , ..... HI^'IIIUIIIIIVIILLJIII^^^^ '.tiiii'iii,:::!,! ,,,', fป\ ........
A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion of
the various options available for satisfying the generic data requirements of this Notice is
contained in Section ni-C. A discussion of options relating to requests for data waivers is
contained in Section HI-D,
( , , ,'
Two fpri?8 aEEty i? generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the Data-Call-in
Response Form(Insert A), and the Requirements Status and Registrant's Response Formrrinsert
Ite Data Call-In Response Formsrinsert A) must be submitted as part of every response to
this Notice. The Requirements Status and Registrant's Response FormsrTnsert B) also must be
submitted if you do not qualify for a Generic Data Exemption or are not requesting voluntary
cancellation of your registration(s). Please note that the company's authorized representative is
required to sign the first page of both Data Call-in Response FormsOnsert A) and the
Requirements Status and Registrant's Response FormsrTnsert B) and initial any subsequent pages.
The forms contain separate detailed instructions on the response options. Do not alter the printed
mat!!}al: Jฃyฐ,u, llay.? 9u??!ions or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment i .
a. Voluntary Cancellation -
i ' "
You may avoid the requirements of this Notice by requesting voluntary cancellation of your
produces) containing the active ingredient that is the subject of this Notice. If you wish to
voluttte$y cancel yฐur Product, you must submit completed Generic and Product Specific Data
.Call-In Response Forms(Insert A), indicating your election of this option. Voluntary cancellation
200
iIIin iii IIill in 11 in
Illlllllllllllll IIIII I IlillHII IIII Illllll I III I ill 111 l|l III 111 I I III III I III III III nil I I Illllllll il I III III I III Hill III I I IIIII I III I [I III I Illl III IHH III III III IIII 11 11 Illlllll I ill III Illlllllllllllllllllll Illlllllllllllllllllll I Ilillll II
-------
is item number 5 on both Data Call-in Response Fbrmrs). If you choose this option, these are the
only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
, b. UseDeletion-
You may avoid the requirements of this Notice by eliminating the uses of your product to
which the requirements apply. If you wish to amend your registration to delete uses, you must
submit the Requirements Status and Registrant's Response Form (Insert B), a completed
application for amendment, a copy of your proposed amended labeling, and all other information
required for processing the application. Use deletion is option number 7 under item 9 in the
instructions for the Requirements Status and Registrant's Response Forms (Insert B). You must
also complete a Data Call-In-Response Formrinserf A) by signing the certification, item number 8.
Application forms for amending registrations may be obtained from the Registration Support
Branch, Registration Division, Office of Pesticide Programs, EPA, by calling (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due date of
your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption - ,
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is exempt
from the requirement to submit or cite generic data concerning an active ingredient if the active -
ingredient in the product is derived exclusively from purchased, registered pesticide^products
containing the active-ingredient. EPA has concluded, as an exercise of its discretion, that it
normally will not suspend the registration of a product which would qualify and continue to
qualify for the generic data exemption in section 3(c)(2)|D) of FIFRA. To qualify, all of the
following requirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient
and is purchased from a source hot connected with you; - '
(ii). Every registrant who is the ultimate source of the active ingredient in your product
subject to this DCI must be in compliance with the requirements of this Notice and must
remain in compliance; and - -
(iii). You must have provided to EPA an accurate and current "Confidential Statement of .
Formula" for each of your products to which this Notice applies. :
201
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I I
To apply for the Generic Data Exemption you must submit a completed Data Call -In
Response Formflnsert A), Attachment 2 and all supporting documentation. The Generic Data
Exgmption is item number 6a on the Data Call-in Response Form(Insert A). If you claim a generic
data exemption you are not required to complete the Requirements Status and Registrant's
Response Form (Insert A). Generic Data Exemption cannot be selected as an option for
responding to product specific data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons to
provide the Agency with the required data. If the registrants) who have committed to generate
and submit the required data fail to take appropriate steps to meet requirements or are no longer
In compliance with this Data Call-in Notice, the Agency will consider that both they and you are
not compliance and will normally initiate proceedings to suspend the registrations of both your
and Aeirprodu_ct(s)? unless'you commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant a time extension for submitting
the data. [[[ " ...... : [[[ _ ...... ' .......... ........... , ...........
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this Notice.
These options are discussed in Section EI-C.l. of this Notice and comprise options 1 through 6 of
item 9 in the instructions for the Requirements Status and Registrant's Response Formflnsert B)
and item 6b on the Data Call-In Response Form (Insert A). If you choose item 6b (agree to
^B ilSSJ!3^.i?5ฃ^?. ...... dateregmrements).,. you must submit the Data Call-in Response FormOnsert A)
j'jih&JEg Requirements g'tatus and Registrant's Response Form(Insert B) as well as any other
..... to the ...... option chosen to address the data requirement. Your response
........ m item', number ..... 3. ................................................
e. Request for Generic Data Waivers.
iJ"i::iH!!"lIIT Kill,
Waivers for generic data are discussed in Section ni-D.l. of this Notice and are covered by
,,, ,;if,,, ^pptions 8_and 9 of itemjHiithe insfructionsJorfoe Requirements Status and Registrant's
:""" I"11'1:'1'11111 ,,-:.,.,,,,,,.,, fee^ponse FV>rcn(tnsert Bl. If you choose one ofthese options, you must submit both forms as well
as any other information/data pertaining to the option chosen to address the data requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice or
(c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section in-C.2. A discussion of options relating
-------
' - >
Two form's apply to the product specific data requirements one or both of which must be
used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Formansert A), and the Requirements Status and Registrant's Response
Formphisert B), for product specific data. The Data Call-in Response Form (Insert A) must be
submitted as part of every response to this Notice. In addition, one copy of the Requirements
Status and Registrant's Response Formrinsert B) also must be submitted for each product listed
on the Data Call-in Response Formrinsert A1 unless the voluntary cancellation option is selected.
Please note that the company's authorized representative is required to sign the first page of the
Data Call-in Response Formansert A) and Requirements Status and Registrant's Response Form
(Insert B) (if this form is required) and initial any subsequent pages. The forms contain separate
detailed instructions on the response options. Do not alter the printed material. If you have
questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachment 1. ,
' ' ' '
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of your
product(s) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit a completed Data Call-in Response FormOnsert
A), indicating your election of this option.' Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response FormsOnsert BY If you choose this option,
you must complete both Data Call-In response forms. These are the only forms that you are
required to complete. ;
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which aire contained in Section IV-C.
b. * Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements- of this
Notice. These options are discussed in Section EI-C. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Formdnsert B) and item numbers 7a and 7b (agree to satisfy the product
specific data requirements for an MUP or EUP as applicable) on the product specific Data Call-in
Response Formansert A). Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements. Deletion of
a use(s) and the low volume/minor use option are not valid options for fulfilling product specific
data requirements, It is important to ensure that you .are using the correct forms and instructions..
when completing your response to the Reregistration Eligibility Decision document.
v
c. Request for Product Specific Data Waivers. ' .
Waivers for product specific data are discussed in Section ni-D.2. of this Notice and are
covered by option 7 of item 9 in the instructions for the Requirements Status and Registrant's
'. 203 '
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Response Form(Insert B). If you choose this option, you must submit the Data Call-In Response
Formflnsert A) and the R^uirgrnents_Status and Registrant's Response Form(Insert B) as well as
any other information/data pertaining to the option chosen to address the data requirement. Your
response must be on me form's markedKpRopUCf SPECilFIC"Tn"Itemlumber's.
m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
ill11 i M i 11 M iiiiiiiiii i n ii ii 11 u i 11 i i i' iin
1. Generic Data
' " i
If you acknowledge on the Generic Data Call-In Response Formflnsert A) that you agree
to satisfy the generic data requirements (i.e. you select item number 6b), then you must select one
of the six pptions on the Generic Requirements Status and Registrant's Response Formf Insert B)
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 Form. These six options are listed immediately below with information
in parentheses to guide you to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (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) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and up^E^Heabi'e '^pg^'ding' 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
guidelines and with other Agency requirements as referenced herein and in the attachments. All
data generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40
CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be in
conformance with the requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which a protocol must
be submitted havebeen identified in .the,. Requirements Status and Registrant's Response
Formflnsert B) and/or footnotes to the form. If you wish to use a protocol which differs from the
options discussed in Section II-C of this Notice, you must submit a detailed description of the
proposed protocol and your reason for wishing to use it. The Agency may choose to reject a
protocol not specified in Section ri-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will not be a basis
for extending the deadline for submission of data.
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A progress report must be submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other.means to address that study requirement,
such as making an offer to cost share or agreeing to share in the cost of developing that study
This 90-day progress report must include the date the study was or will be initiated arid, for
studies to be.started within 12 months of commitment, the name and address of the
laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the,other information
specified in the preceding paragraph; at a'minimum, a brief description of current activity on and
the status of the study must be included as well as a full description of any problems encountered
since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form/Insert B) are
the time frames that the Agency is allowing for the submission of completed study reports or
protocols. 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 and
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 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. " ' .
Option 2. Agreement to Share in Cost to.Develop Data
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 EPA with documentary 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. '
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ii11 i HI 111 inn i minim 111 mini i i ii i i i i in i H nini w i i i i ii IPI
Option 3. Offer to Share in the Cost of Data Development
, ' ' ' "
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 be you may
request EPA (by selecting this option) to exercise its discretion not to suspend your
registration^), although you did not comply with the data submission requirements of this Notice.
EPA has detemiriedftatas a general policy, absent other relevant considerations, it will not
suspend the registration oฃa protJuct of a registrant who has in good faith sought and continues to
9 HMln!ฐ S Jฐ'nt data developmenl/cost sharing program, but the other registrant(s)
the data has refused to accept the offer. To qualify for this option, you must submit
tion tolhe! 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 Certification with Respect to Citations of Data (in PR Notice 98-5)
(EPA Form 8570-34) . In addition, you must demonstrate that the other registrant to whom the
offer was made has not accepted your offer to enter into a cost-sharing agreement by including a
copyof yourofferand 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 to or, failing agreement, to be bound by binding arbitration as
P^,d,?d by FIFRA,.se.ction 3(c)(2)(BXui) and must not qualify this offer. The other registrant
m!!fi 'ajso jnform EPA of its election of anoption to develop and submit the data required by this
Notice by submitting a Data Call-In Response FormOnsert A) and a Requirements Status and
Registrant's Response Form(Insert B) committing to develop and submit the data required by this
Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burden of developing the data. In additign, theother-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 normally will be subject to initiation of suspension proceedings, unless
you commit to submit, and dp 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.
i
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.
206
ii in i i mil
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To meet the .requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
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, 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, 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 also must certify at the time of
: submission of 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.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
documents available from NTIS). A study not conducted according to the PAG
may be submitted to the Agency for consideration if the registrant believes that the
study clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you wish
to submit the study, you must, in addition to certifying that, the purposes of the
PAG are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data usually
are not available, for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above. .
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If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed in the
final protocol and study. .
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such a study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5 entitled "Standard Format for Data Submitted
under FEFRA".
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit data
to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still be
required to submit new data normally without any time extension. Deficient, but upgradeable
studies will normally be classified as supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the contact person
listed in Attachment 1. If you submit data to upgrade an existing study you must satisfy or supply
information to correct all deficiencies in the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or corrected and why the study
should be rated as acceptable to EPA. Your submission must also specify the MRID number(s) of
the study which you are attempting to upgrade and must be in conformance with PR Notice 86-5
entitled "Standard Format for Data Submitted under FIFRA."
i
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being upgraded.
II || | || I III I || I ||I 11| || I I || I II III I I I I II I I II J O "53iii|. "ii r i.
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"core-guideline" or "core-minimum." For ecological effects studies, the classification generally
would be a rating of "core." 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 MRJD
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 No. 8570-34, Certification with Respect to Citations of Data.
2. Product Specific Data (
If you acknowledge on the product specific Data Call-in Response Formrinserf A) that you
agree to satisfy the product specific data requirements (i.e. you select option 7a or 7b), then you
must select one of the six options on the Requirements Status and Registrant's Response
. Form(Insert B) 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 BY 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 a'rri submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am. 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 - The requirements for developing product specific data.are the same
as those described for generic data (see Section HLC. 1, Option 1) except that normally no
protocols or progress reports are required.
,-'' ' " " -" i
Option 2. Agree to Share in Cost to Develop Data - If you enter into an agreement to cost share,
the same requirements apply to product specific data as to generic data (see Section IH.C. 1,
Option 2). However, 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 this 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.
- 209 -
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Option 3. Offer to Share in the Cost of Data Development The same requirements for generic
data (Section HI.C.I., Option 3) apply to this option. This option only applies to acute toxi city
and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study The same requirements described for generic data (see
Section IELC. 1 ., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study The same requirements described for generic data (see Section
.................................................. IJI.C 1,.,, ...... Option 5) apply to this ogtion for product specific data.
, j .
Option 6. Citing Existing Studies The same requirements described for generic data (ssft
Section in.C.L, Option 6) apply to this option for product specific data.
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 Formdnsert A) and the
Requirements Status and Registrant's Response Formflnsert B). and in the generic data
requirements section (III. C.I. ), as appropriate.
'''ill1 fill! < ......... in M!,,, '!'! ,!ii'' li:i||||||| , i| ..... ..... ' , i|illiliil"li il !' "! )' :' ,f b L ' ill 111! ...... I "illli ,!:"ป. ill"!1! , ...... Ill ..... Pill ' .'til! "< '!'"i ...... .., ', , !, I '!' !'"! '' II ll'Ji , iff !" ( ' ' !' ,. Ji i: Ilini'1 ill ' >' ..... /. II lllv'lii1!, ..... ''I" " 11,%'. 1 11 I'v r i"'r Mill '" i'l' ,' ,',,!!" , "ป 'ill'1'. ,'" , ''T'J "I, ........ il'il! ..... <<"i ,' llll'TI! ' ' ft, ;, ' " '.Ml1 ' ..... h I" ' <';ii<'< I! H1' ' i!'P,'!',!l ' i'lvi sure a33 risk from use of the pesticide. If an active ingredient is used for both high'
volume and low yofume useง, a low volume exemption will not be approved. If all uses of
an active ingredient are low volume and the combined volumes for all uses are also low,
then an exeniption mav_ be s_ granted, .depending on review of other information outlined
below, An exemption will not be granted if any registrant of the active ingredient elects to
conduct the testing. Any registrant receiving a low volume/minor use waiver must remain
within the sales figures in their forecast supporting the waiver request in order to remain
qualified for such waiver. If granted a waiver, a registrant will be required, as a condition of
210
"I11!111
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the waiver, to submit annual sales reports. The Agency will respond to requests for waivers
in writing. . . .
To apply for a low volume/minor use waiver, you must submit the following information
as applicable to your product(s), as part of your 90-day response to this Notice:
(i). Total company sales (pounds and dollars) of all registered produces)
containing the active ingredient. Jf applicable to the active ingredient, include foreign sales
for those products that are not registered in this country but are applied to sugar (cane or
beet), coffee, bananas, cocoa, and other such crops. Present the above information by year
for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active ingredient
for. each maj or use site. Present the above information by year for each of the past five
years.
(iii) Total direct production cost of produces) containing the active ingredient by
year for the past five years. Include information on raw material cost, direct labor cost
advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the, past five
years. Exclude all non-recurring .costs that were directly related to the active ingredient
such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the type
of waiver sought and the estimated cost to you (listed separately for each data requirement
and associated test) of conducting the testing needed to fulfill each of these data
requirements.
(vi) A list of each data requirement for which you are not seeking any waiver and
the estimated cost to you (listed separately for each data requirement and associated test)
of conducting .the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the parameters in
item 3 above), and costs of data development pertaining to the active ingredient.
(viii) A description of the importance and unique benefits of the active ingredient
to users. Discuss the use patterns and the effectiveness of the active ingredient relative to
registered alternative chemicals and non-chemical control strategies. Focus on benefits
unique to the active ingredient, providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then present the
211
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reasoning used to derive your estimates. To assist the Agency in determining the degree of
importance of the active ingredient in terms of its benefits, you should provide information
onjny'pf the ..... fpllowing^fact^ (a) documentation of the
usefulness oFthe active ingredient in Integrated Pest Management, (b) description of the
ben.ejcjil impacts on the environment of use of the active ingredient, as opposed to its
registered alternatives, (c) information on the breakdown of the active ingredient after use
and on its persistence in the environment, and (d) description of its usefulness against a
pest(s) of public health significance.
1111
Failure tojufemi^sulgpiejnil; information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the request
'."" ....... . ........ ""^for a waiver. ................ , [[[ _ [[[
b. Request for Waiver of Data
in in i n i i n i minium i 11 i in mi;;:1, '"L^iiliiiiiiLhiiiii1111 lil'l,,'" ' "a ป, il . ,hi: "l.liiniiii1] , ..... ?, Bin "!,! ', ,*, .i*1',,}'!1 "! ;,,i 'ป"ii J'1 vii.': ', i ป//:i miff vm('ป:i,,, 'ซ. puur -\ ..... iiii'i, .i ..... ''"i"1 . Vj 4 ^Jii,.Nn:,ii,,, ,,,,,,& '',3ii ,ซ ,'',':,' ' ""W i.': i" i". v'iii iiir' 'j-imiii'ivr nuiiin !lf iiPiii1,. i,
( Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement should not
apply because the requirement is inappropriate. You must submit a rationale explaining
why you believe the data requirements should not apply. You also must submit the current
label(s) of your product(s) and, if a current copy of your Confidential Statement of
Formula is not already on file you must submit a current copy.
j*
i
You will be informed of the_Agency's ; decision in writing. If tiie Agency determines
that the data requirements of this Notice are not appropriate to your product(s), you will
not be required to supply the datapursuanlto sectionl ............................................
the data are required for your productfsX'you must choose a method of meeting the
requirements of this Notice within the time frame provided by this Notice. Within 30 days
of your receipt of the Agency's written decision, you must submit a revised Requirements
Status and Registrant's Response Form indicating the option chosen.
\
2; Product Specific Data
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 product specific Requirements Status and Registrant's Response FoiWInsert B).
Product specific data requirements for product chemistry, acute toxicity and efficacy
-------
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.
' /
SECTION 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
FIFRA section 3 (c)(2)(B). Events-which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice. , ' , .
t ' ' ' , '
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as 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
, information 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 HI-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom 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. Inform EPA of intent to develop and submit the data required by this Notice on
a Data Call-in Response Form (Insert A') and a Requirements Status and
Registrant's Response FormfTnserf R)
' . ' ' -. ' ' ' 213 ' ' / ' " ' :
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9,
b. Fulfill the commitment to develop and submit the data as required by this
Notice; or
i
c. Otherwise take appropriate steps to meet the requirements stated in this Notice,
unless you commit to submit and do submit the required data in the specified time
frame.
, ' , ' , ' ^t '
Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
ill ill11 1 i ill i ill in
I IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
i
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:
i i ii i in n i i i n i mi in n in inn i i n n i i n i i in nun ii i n i i ii 1 1 n ii mm i i i i i i i
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.
............. ii ii
IV-C. EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesficiHe product'wnich' has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
i in i n in i i i ii i i i n ii i i iii in * A f i
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section -j^p^g) (jata requesf js outstanding generally would not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended produces) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
214
Mill)
\ III ill
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clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You also must 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, 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
cancelled products containing an active ingredient for which the Agency has particular risk
concerns will be determined on a 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 factual 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 VL INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice must include completed Data Call-In Response Forms (Insert
A)and completed Requirements Status and Registrant's Response Forms (Insert B), for both
, 215 '.'"'
-------
Ill
(generic and product specific data) and any other documents required by this Notice, and should
be submitted to the contact person(s) identified in Attachment 1. If the voluntary cancellation or
generic data exemption option is chosen, only the Generic and Product Specific Data Call-in
Response Formsdnsert A) need be submitted.
I |
The Office of Compliance (OC) of the Office pf Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
i '
,'! ""B ' , ' '
Sincerely yc
eois A. Kos^) Director
'Special Review and
Reregistration Division
Attachments
inn
The Attachments to this Notice are:
IT I. / '
1 _- Data Call-in Chemical Status Sheet
2 - Generic Data Call-in and Product Specific Data Call-In Response Forms with
Instructions : , , '
3 - Generic Data Call-In and Product Specific Data Call-in Requirements Status and
Registrant's Response Forms with instructions
if^Ti EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistratipn
5 - List of Registrants Receiving This Notice
216
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DICOFOL DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have product(s)
containing Dicofol.
This Product Specific Data Call-in Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of 0021.
This attachment is to be used in conjunction with (1) the Product Specific Data Call-in Notice (2)
the Product Specific Data Call-in Response Form (Attachment 2), (3) the Requirements Status'and
Registrant's Form (Attachment 3), (4) EPAs Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirement (Attachment 4), and (5) a list of registrants receiving this DCI
(Attachment 5). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Dicofol are contained
m the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional data on Dicofol are needed for specific products. These data are required to be submitted
to the Agency within the time frame listed. These data are needed to fully complete the reregistration
of all eligible Dicofol products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Venus Eagle at (703) 308-8045.'
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Venus Eagle , ' ,
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508C
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Dicofol
217
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bi'cofol DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-in Notice because you have product(s) containing
Dicofbl, , [ '"
This Generic Data Call-In Chemical Status Sheet contains an overview of data required by this
notice, and point of contact for inquiries pertaining to the reregistration of Dicofol. This attachment
is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data Call-In
Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form (Attachment 3),
and (4) a list of registrants receiving this DCI (Attachment 5). Instructions and guidance accompany
each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Dicofol are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional product chemistry data on Dicofol are needed. These data are needed to
fully complete the reregistration of all eligible Dicofol products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures established
by this Notice, please contact Phil Budig at (703) 308-8029.
All responsades to this Notice for the generic data requirements should be submitted to:
Phil Budig, Chemical Review Manager
Special Review Branch
Special Review and Registration Division (H7508W)
Office of Pesticiafde Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Dicofol
llll 111 I I
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218
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-in Response Forms"
(Insert A) and are to be used by registrants to respond to generic and product specific Data
Call-ins as part of EPA's Reregistration Program under the Federal Insecticide, Fungicide and
Rodenticide Act. If you are an end-use product registrant only and have been sent this DCI letter
as part of a RED document you have been sent just the product specific "Data Call-in Response
Forms. '(Insert A) Only registrants responsible for generic data have been sent the generic data
response form. The type of Data Call-in (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out the
forms. " ,
EPA has developed these forms individually for each registrant, and has preprinted these forms
with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed by the
registrant as appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15 minutes
per response, including time for reviewing instructions, searching existing data sources gathering
and maintaining the data needed, and completing and reviewing the collection of information
Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to Chief, Information Policy Branch
Mail Code 2137, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107 "
Washington, D.C. 20503. ."''...,'
219
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
' . ' , ' ; ' (INSERT A^
. Generic and Product Specific Data Call-In
Item 1.
.
ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2.
Item 3.
Ite,m 4.
ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
ON BOTH FORMS: This item identifies the type of Data Call-in. The date of
issuance is date stamped.
.' i . . - '.''.' " ''' ' ;
ON BOTH FORMS: This item identifies the EPA product registrations relevant
to the data call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be covered by
this Data Call-in but that is not listed by the Agency in Item 4. You must bring any
such apparent omission to the Agency's attention within kthe period required for
submission of this response form.
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previously requested voluntary cancellation, indicate in Item 5 the date of that
ii.rtvrequest. Since this Data Call-In requires both generic and product specific data, you
::;:,:Sฃ^'^;S';"3;;i'j;^J:is^ complete item 5 on both Data Call-in response forms. You do not need to
complete any item on the Requirements Status and Registrant's Response Forms
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Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is for
generic data as indicated in Item 3 and you are eligible for a Generic Data
Exemption for the chemical listed in Item 2 and used in the subject product. By
electing this exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that you use
in your product.
1 < '
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Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance with
this and any other outstanding Data Call-In Notice), and incorporate that product
into a"li"youf"lplro8ucts, you may complete this item for all products listed on this
form. If, however, you produce the active ingredient yourself, or use any
unregistered product (regardless of the fact mat some of your sources are
registered), you may not claim a Generic Data Exemption and you may not select
- this item. ' ;.. '. '. ' '.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
(INSERTS)
Generic and Product Specific Data Call-in
Item 6b. ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data
requirements of this Data Call-in. Attach the Requirements Status and Registrant's
Response Form(Insert B) that indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item/a. ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing
rirrimip.t iN/fTTP^-fXr nrVitr'li TT^TI .ซnU .*.ซ ;.!._ .,
use
product (MUP) for which you wish to maintain registration, you must agree to"
satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration you,
must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your
product is identical to another product and you qualify for a data exemption. You
t , must provide the EPA registration numbers of your source(s); do 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.
If you are requesting a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form under Item 9 you must
respond with option 7 (Waiver Request) for each study for which you are
1 requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
221
-------
liRII ' IliW^^^^^^ miSa. ' ' '
INSTRUCTIONS FOR COMPLFTTNC; THF. DATA CALL-IN RESPONSE FORMS
(INSERT B) CONTINUED
i
Generic and Product Specific Data Call-In
i
Item 8. ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her title.
Additional pages used in your response must be initialed and dated in the space
provided for the certification.
Item 9. ON BOTH FORMS: Enter the date of signature.
'
n n n n
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS; Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form in a
signed letter that accompanies your response. 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.
Kill i I ill "(HI III I I ii lillllili i i i ll ii I i n I I i I i 11 ilMi I i > i i i , II III
222
-------
Instructions For Completing The "Requirements Status and Registrant's Response
Forms" (Insert B) For The Generic and Product Specific Data CalWn
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms",and are to be used by registrants to respond to generic and product
specific Data Call-in's as part of EPA's reregistration program under the Federal Insecticide,
Fungicide, and Rodenticide Act. If you are an end-use product registrant only and have been
sent this DCI letter as part of a RED document you have been sent just the product specific
"Requirements Status and Registrant's Response Forms." Only registrants responsible for generic
data have been sent the generic data response forms. The type of Data Call-in (generic or
product specific) is indicated in item number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include (1) deletion of uses or (2) request for a low volume/minor use
waiver. Please read these instructions carefully before filling out the forms.
__ EPA has developed these forms individually for each registrant, and has preprinted these
forms'to include certain information unique to this chemical. DO NOT use these forms for any
other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated, to average 30
minutes,per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, Mail Code 2137, U.S. Environmental Protection Agency, 401 M St., S.W., Washington,
D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction Project
2070-0107, Washington, D.C. 20503.
223
-------
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS" (Insert B)
Generic and Product Specific Data Call-In
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Item 1. ON BOTH FORMS: This item identifies your company name, number and
:ฐ "-''- "-'' address. ' ' '"' :
::.item. 2. ON TOE. GENERIC DATA FORM:, This item ...identifies, the, case number, case
name, EPA chemical number and chemical name.
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ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the case
number, caseiname, and the EPA Registration^Number of the product for which the
Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type of
Data Call-In. The date of issuance is also date stamped. Note the unique identifier
number (TD#) assigned by the Agency. This. ID number; must be used in the
transmittal document for any data submissions in response to this Data Call-In
Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in the
Data Call-In 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, Subpartc.
Item 5. ON BOTH FORMS:'" This item' identifies .the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section HI of the Data Call-In Notice, 90-day progress reports are required for all
studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's Response
Form (Insert B).
224
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS" (Insert B) continued
Generic and Product Specific Data Call-in ' ' " '
Item 6. ON BOTH FORMS: This item.identifies the code associated with the use pattern
ol the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use sites
and/or pests indicated. A brief description of each code follows:
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 crop
J Forestry ,
K Residential
L Indoor food
M Indoor non-food '-'-. .
N Indoor medical
O Indoor residential ,
Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance that
must be used for testing, A brief description of each code follows:
, , EUP End-Use Product
MP Manufacturing-Use Product ' - . ~
W/TGAI Manufacturing-Use Product and Technical Grade Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites .
J^f;?^ PureActiveIndredientorPute Active Ingredient Radiolabelled
PAiRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant Metabolites
TEP Typical End-Use Product ,
- ^/0 "TyPicalEnd-Use Product, Percent Active Ingredient Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PALM Typical End-Use Product or Pure Active Ingredient and
Metabolites
TGAI , Technical Grade Active Ingredient
TGAI/PAI Technical Grade Active Ingredient or Pure Active Ingredient
, TGAI/PAIRA Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled :
^ i , -
225
-------
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MET Metabolites : =':'''' :"'"': """', % , ',' " " '". [ ":
IMP Impurities
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Item 8, This item completed by the Agency identifies the time frame allowed for submission
l$"I$?#J!f : of the study or protocol identified in item 5. ' '
' "
'-r:::/-". ::':; ON THE GENERIC DATA FORM: The time frame runs from the date of your
receipt of the Data Call-In notice.
ii'ljvj, llHS'iifti II trill*:! : ", I III II ..... ":.,r llllll!!!!]* JH!1! ...... '".tt,:: H ""ป! IIII IIIIIIIIII _ I II I II I I III III I II I II 111 I III II I |l I 11 II I II U I 11 III 1 1 III III III I I 111 III III il I I I II I I I I II I I III
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~'' "" ..... '")"Mi*' ............................. '
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
fjpw you intend to comply with each data requirement. Brief descriptions of each
code follow. The Data Call-In Notice contains a fuller description of each of these
options.
I I III Illlllllll I Illlllllll I i II II II III I n i 11 i I i 1(1 I 1 n I '.!i!:i.;:;'iitf.."i"M;i;t,'
Option 1. ON BOTH FORMS: (Developing Data^ I will conduct a new study and
i submit it within the time frames specified in item 8 above. By indicating that
llllll I I 11(11 I I I Illlllllll,, , ., . . T * "i'S^ = ;:; ; ;; ;^-'; p
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 and that I wjll provide the protocols and
progress reports required in item 5 above.
I I: 1
Qption 2. ON BOTH FORMS: (Agreement to Cost Shared I have entered into an
agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply with all
the requirements pertaining to sharing in the cost of developing data as
-; -i !;'' '"" ' ' -"' outlined in the Data Call-In Notice.
Howeverj for Product Specific -Data, I understand that this option is
available for acute toxicity or certain efficacy data ONLY if the Agency 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.
I n in n n iiii|i I il II n llllll I I n I i I I I I I in I I I 11
Option 3. ON BOTH FORMS: (Offer to Cost Share} I have made an offer to enter
into an agreement with one or more registrants to develop data jointly. I am
also submitting a completed "Certification of offer to Cost Share in the
Development of Data" form. I am submitting evidence that I have made an
226
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-------
offer to another registrant (who has an obligation to submit data) to share in
the cost of that data. lam including a copy of my offer and proof of the
other registrant's receipt of that offer. I am identifying the party which 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. I .
understand that other terms under Option 3 in the Data Call-in Notice apply
as well.
However, for Product Specific Data, I understand that this option is
available only for acute toxicity or certain efficacy data and only if the Agency
indicates in an attachment to this Data Call-in Notice that my product is similar
enough to another product to qualify for this option.
Option 4. ON BOTH FORMS: (Submitting ExistWn^ I will- submit an existing
study by the specified due date that has never before been submitted to
EPA. By indicating that I have chosen this option, I certify that this study
meets all the requirements pertaining to the conditions for submittal of
existing data outlined in the Data Call-in Notice and! have attached the
needed supporting information along with this response.
Options." ONBOTHFORMS: (Upgrading a Studv^ I will submit by the .specified
due date, or will cite data to upgrade a study that EPA has classified as
, partially acceptable and potentially upgradeable. . By indicating that I have
. chosen this option, I certify that I have met all the requirements pertaining
to the conditions for submitting or citing existing data to upgrade a study
described in the Data Call-in Notice. I am indicating on attached
correspondence the Master Record Identification Number (MRID) that
EPA has assigned to the data that I am citing as well as the MRID of the
study I am attempting to upgrade.
Option 6. ONBOTHFORMS: (Cjting^Study.) I am citing an existing study that
, has been previously classified by EPA as acceptable, core, core minimum, or
a study that has not yet been reviewed by the Agency. If reviewed, I am
providing the Agency's classification of the study.
However, for Product Specific Data, 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 the Agency 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 MRID or
Accession number (s). If I cite another registrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements" form.
' 227
-------
FOR THE GENERIC DATA FORM ONLY: The following three options (Numbers
7, 8, and 9) are responses that apply only to the "Requirements Status and
Registrant's Response Form" (Insert B) for generic data.
I n nil n n n n i ii in mi i ii i ii ii i ii j ii i I i iiiinii jfi i i ii i i MI H inn 11
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Option 7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I am
attaching a detailed justification to support this waiver request including,
among other things, all information required to support the request. I
understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
,i ' " i , "
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in .the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching a
rationale explaining why I believe the data requirements do not apply. I am
also submitting a copy of my current labels. (You must also submit a copy
of your Confidential Statement of Formula if 'not already on file with EPA).
I understand that, unless modified by the Agency in writing, the data
requirement as stated in the Notice governs.
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B) for product specific data.
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Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
: - f - < - -
Item 13, ' ON BOTH FORMS: Enter the phone number of your company contact.
NOTE: You may provide additional information that does not fit on this form in a signed letter
that accompanies this your response. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily cancelled this product For these cases, please supply all relevant details so
that the Agency can ensure that its records are correct.
229
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EPA'S BATCHINGOFDICOFOL PRODUCTS FOR MEETING ACUTE TOXICITYDATA
REQUIREMENTS FOR REREGISTRATION '
-In an effort to reduce the time, resources, and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing Dicofol 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 include each product's active and inert ingredients (identity
percent composition, and biological activity), type of formulation (e.g., emulsifiable concentrate'
aerosol, wettable powder, granular, etb.), 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.
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
at any time, acute toxicity data for an individual product should the need arise.
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 registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of 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 valid 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 are generated or existing data are 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 in the Data Call-in (DCp Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-in Response," asks whether the registrant will meet
the data requirements for.each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate 'in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option IV
Submitting an Existing Study (Option 4); Upgrading an Existing Study (Option 5); or, Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among- Cost
Sharing (Option 2); Offers to Cost Share (Option 3); or, Citing an Existing Study (Option 6) If a
registrant does not want to participate in a batch, the choices are Options 1, 4/5, or 6. However a
230
-------
registrant should know that choosing not to participate in a batch does not preclude other registrants
in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
Fourteen (14) products were found which contain Dicofol as the active ingredient. These
products have been placed into three batches and a "no batch" category, in accordance with the active *
and inert ingredients and type of formulation. Furthermore, the following bridging strategies are
deemed acceptable for this chemical:
" p ' ' s
Product 34704-513 in the "No Batch" Group may be supported by the products in Batch 2,
with the exception of Eye Irritation Test data.
NOTE: The technical acute toxiciry values included in this document are for informational purposes
only. The data supporting these values may or may not meet the current acceptance criteria.
Batch EPA % Active Formulation
Reg. No. Ingredient Type
1 707-203 ; 95.3% Powder
11603-26 88.0% Powder
Batch
EPA
Reg. No.
707-202
56222-21
% Active
Ingredient
42.0
42.0
Formulation
Type
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Liquid
ii I
Batch
EPA
Reg. No.
% Active
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Formulation
Type
707-204
10163-96
18.5
18.5
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Liquid
No
Batch
EPA
Reg. No.
% Active
Ingredient
Formulation
Type
707-229
51036-75
50.0
42.0
Powder
Liauid
231
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No
Batch
mm^mmm
EPA.
Reg. No.
54704-513
707-201
707-205
239-2574
239-2575
0163-234
% Active
Ingredient '
.41.1
.41.0
35.0
3.0, plus
4.00% Orthene
3.25% Triforine
3:0, plus
8.00% Orthene
3.0
Formulation
MMJI^^^^^^^H
Liquid
Liquid
Solid .
Liquid
Liquid
Powder
232
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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.ffov/opprdd01/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.
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 Information1
or'Sensitive Information.1
j -,"'- _
.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: .
a) Form 8 570-1 Application for Pesticide Registration/Amendment-
http://www.eva.zov/opprd001/forms/8570-Lpdf.
b) Form 8570-4 Confidential Statement of Formula-
http://www.epa.ffov/opprd001/forms/8570-4.pdf.
c). Form 8570-32 Certification of Attempt to Enter into an Agreement with other
Registrants for Development of Data -
http://www.epa.fov/opprdOOJ/forms/8570-32.pdf
d) Form 8570-34 Certification with Respect to Citations of Data (in PR Notice 98-5)
- http://www.epa.eov/opppmsdl/PR Notices/pr98-5.pdf.
e) Form 8570-3 5 Data Matrix (in PR Notice 98-5) -
http://www.epa.ffov/opppmsdl/PR Notices/pr9 8-5.pdf.
f) Form 8570-36 Summary of the Physical/Chemical Properties (in PR Notice 98-1) -
http://www. epa. ffov/opppmsdl/PR Notices/pr98-l.pdf.
g) Form 8570-37 Self-Certification Statement for the Physical/Chemical Properties (in
PR Notice 98-1) - http:/Avww.epa.gov/opppmsdl/PR_Notices/pr98-l.pdf.
s 235 - .
-------
1
i i ilium ii|i
Pesticide Registration Kit www.epa.gov/pesticides/resisfrationkit/.
Dear Registrant:
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 Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (pp^Q^ as Amended by the FoodQuality Protection
Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement ProgramStorage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA " ^ .
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
ft ?8r^S^ฃgIfeiJSJ^ ^..with^Attadunents (This;
document is in PDF format and requires the Acrobat reader.)
I i || i ii 111111111111^ MI i i IN i inn i iiiiuivn^ T L >
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will r,pquire the Acrobat reader.)
a. EPA Form No. 3570-1, Application for Pesticide Registration/Amendment
b, EPA Form No. 8570-4, Confidential Statement of Formula
C. EPAFormTN6. 8570-27, Formulatoijs Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader.)
a. Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
b. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
c. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
d. 40 CFR Part 158, Data Requirements for Registration (PDF format)
e. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
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
236
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2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) the following address:
National Technical Information Service (NTIS)
\ 5285 Port Royal Road
Springfield, 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 and the reorganization of the Office of Pesticide
Programs. We anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does
charge a fee for subscriptions and custom searches. You can contact NPIRS by
telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information
. . on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact
NPTN by telephone at 1-800-858-7378 or through their Web site.
The 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 completed by OPP:
Date of receipt
< EPA identifying number
the Product Manager assignment ,
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide the EPA
identifying File Symbol or petition number for the new submission. The identifying number should
be used whenever you contact the Agency concerning an application for registration experimental
use permit, or tolerance petition. ,
To assist us in ensuring that all data you have submitted for the chemical are properly coded
and assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind" codes
used when a sample was submitted for testing by commercial or academic facilities). Please provide
a CAS number if one has been assigned. ,
237
-------
iin ( nil ' ill11 mi" .ii11 i ni i ' i ,i ซi ii ,i i n i i i - (in,(Hi HI
List of Available Related Documents
ซ ,i '
The following is a list of available documents for Dicofol that may further assist you in responding to
this Reregistration Eligibility Decision document. These documents may be obtained by the following
methods: *
t j*
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
Phil Budig at (703) 308-8029. ' ' ' ' | ' __' " ' ^ ' "_ '
I 111 II 11 I II II II II IIIII11 I liill!, Biili .l"!|l|ll'l!>:linllll"' 'f*ii ปปf Vi '[,; .< - ,i"! iปi."" ,,,111, ,'V I WVI'"',,:" Ii ,i< <, J"1, is:"['' II" i', '".''' ' lit:,' II'!' ',' 'i.:,' K, i'.<"!k <,' !!, .:; (! Kitti >,li. 'i1'' "!"; < \' ,,'"il,,' ' "Jill! '']' Jll'l'i". ^Iblilil'illllll!1 liLilillll:,? IIBl1 < I1 ; t\ "'i' '
1. PRNotice 86-5. ''' _ ' ." "; : ; '" ''' ,' " ' '.
* ' ' ' /''
2. PRNotice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED: document.
4. A copy of the fact sheet for Dicofol.
The following documents are part of the Administrative Record for Dicofol and may 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. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
3. 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.
i t . , ' t
1. The Label Review Manual.
2. EPA Acceptance Criteria
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