United States
Environmental Protection
&EPA
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA 738-R-98-022
December 1998
Re registration
Eligibility Decision (RED)
THIODICARB
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United States
Environmental Protection
Agency •
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-98-020
December 1998
&EPA. R.E.D. FACTS
Pesticide
Reregistration
Use Profile
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of advances
in scientific knowledge, the law requires that pesticides which were first
registered before November 1,1984, be reregistered to ensure that they meet,
today's more stringent standards..
In evaluating pesticides for 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 mitiga-
tion measures or regulatory controls needed to effectively reduce each pesti-
cide'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
2675, tbiodicarb, dimethyl N,Nl-(thiobis((methylimino)carbonyloxy))
bis(ethanimidothiQate). , 4 .
Thiodicarb acts as an insecticide against major Lepidopterous, and
suppresses Coleopterous and some Hemipterous insect pests. Thiodicarb acts
as an ovicide against cotton bollworms and budworms. Thiodicarb is used
- primarily on cotton, sweet corn, and soybeans. The remaining usage is spread
among leafy vegetables, cole crops, ornamentals, and other minor use sites.
There are currently 14 tolerances for thiodicarb. Application types for
thiodicarb include aircraft (fixed-wing and helicopter), airblast sprayer,
chemigation, groundboom, high- and low-pressure handwand, backpack
sprayer, and belly-grinder spreader. Thiodicarb is formulated as a liquid,
fiowable concentrate, granular, pelleted/tableted, water dispersible granules,
and wettable powder. There are no homeowner uses of thiodicarb.
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IIP II III
Regulatory Thiodicarb was first registered in the United States in 1984 for use as an
History insecticide. Rhone-Poulenc, Inc., is the current manufacturer of thiodicarb. A
data call-in w.as issued in April 1991. There are 11 thiodicarb products
registered, along with 19 Special Local Needs registrations (SLNs).
Human Health Toxicity
Assessment In acute toxicity testing, thiodicarb places ha Toxicity Category I (the highest
toxicity category out of four) via the oral route and Toxicity Category II via
the inhalation route. For acute dermal effects and eye irritation thiodicarb is in
Toxicity Category III. For acute skin irritation, thiodicarb produced no
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significant increases in testtcular
|. iii mill .mi 'I'lii'ii'iiiii'Winiii'iNii:1: tttiiiiii.iiiiuhiiiiiM •• \« t^
: iri male^ rats, AJhieai: methodology (Qt*) was applied
for the estimation of human cancer risk and was calculated to be 1.88 x 10"2.
In determining whether to retain, reduce, or remove the lOx FQPA safety
factor for infants and children,' £?pA uses a weight of evidence approach taking
into account the completeness and adequacy of the toxicity data base, the :
nature and severity of the effects observed in pre- and post-natal studies, and
exposure. Although the data provided no indication of increased sensitivity of
rats or rabbits to in utero and/or postnatal exposure to thiodicarb, data gaps
exist for the acute and subchronic neurotoxicity studies. These studies would
have yielded cholmesterase inhibition and field observation behavior data, as
well as histppathology of the central and peripheral nervous system which are
not presently available for evaluation. The Agency determined that the 1 Ox
safety factor to account for increased sensitivity of infimts and children should
be reduced from lOx to 3x.
The Agency has determined that thiodicarb has a metabolite, methomyl, which
is also a registered pesticide. Therefore, methomyl residues resulting from
applications of both thiodicarb and methomyl were considered in an aggregate
dietary risk assessment and compared to appropriate toxicological endpoints
for methomyl. ,In addition, for post application exposure to workers, the
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methomyl short and intermediate-term dermal endpoints were used in the risk
assessment because thiodicarb degrades rapidly to methomyl.
Dietary Exposure and Risk
The RfD for thiodicarb was calculated to be 0.03 mg/kg/day from a chronic rat
•toxiciry study. The RfD was based on an increased incidence of extramedullary
hemopqiesis in males and decreased'RBC cholinesterase in females at the.
LOEL. An uncertainiry factor of 100 was used for deriving the RfD and
includes lOx for inter-species extrapolation and lOx for intra-species variation.
An FQPA safety factor of 3x (due to data gaps) was applied to derive an
FQPA adjusted RfD of 0.01 mg/kg/day. Chronic dietary exposure to
thiodicarb alone must be less than 100% of the FQPA adjusted RfD to be
considered below EP A's level of concern. .
For acute dietary risk assessment for thiodicarb alone, a MOE of 1000 is
required for women 13. years and older, as well as for the general population
including infants and children. This MOE includes the conventional MOE of
100 for inter- and intra-species variation, 3x for FQPA, and another 3x for the
use of a LOEL, instead of a NOEL, in the rat developmental study. The FQPA
Safety Factor (3x) is required because of data gaps (acute and subchronic
.neurotoxicity studies). .The acute Monte Carlo dietary analysis for thiodicarb
alone indicates that there are adequate margins of exposure for the U.S.
population, women 13 years and older, children 1 to 6 years old and infants.
The results of the chronic dietary risk evaluation system (ORES) analyses, for
thiodicarb alone, indicate that the anticipated residue contribution for the U.S.
Population occupies 68% of the FQPA adjusted RfD. For females (13 years
and older) 67% of the FQPA adjusted RfD is occupied. For children (1 to 6
years old) and infants, 104% and 43%, respectively, of the FQPA adjusted RfD
is occupied. Although for children (1 to 6 years old), the FQPA adjusted RfD
is slightly exceeded, if more refined estimates of dietary exposure were made
(e.g. residues from field trials) significantly lower chronic risk would be
estimated. Therefore, the chronic risk from exposure to thiodicarb from food
sources is not of concern. .
For the acute aggregate dietary risk assessment for food, for thiodicarb and
methomyl combined, the endpoint for methomyl was used in the risk
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assessment and compared to residues of methomyl from thiodicarb application
plus residues of methomyl from methomyl application. The results of the acute
aggregate exposure analyses for food, for thiodicarb and methomyl show that
there are adequate margins of exposure for the general U. S. population,
children 1 to 6 years of age, and infants.
For the chronic aggregate dietary risk assessment for food, for thiodicarb and
methomyl combined, the RfD for methomyl was used in the risk assessment
and compared to residues of methomyl from thiodicarb application plus
residues of methomyl from methomyl application. The results of the chronic
aggregate exposure analysis indicate that there are no chronic concerns
associated with potential residues of methomyl on foods as the result of
application of thiodicarb and methomyl.
Thiodicarb degrades rapidly to methomyl in the environment. Therefore, the
Agency has calculated drinking water levels of concern (DWLOCs) for
methomyl. The maximum estimated concentrations of methomyl in surface and
ground water are less than the Agency's levels of concern for methomyl in
drinking water as a contribution to acute aggregate exposure. The estimated
average concentrations, of methomyl in surface and ground water are less than
OPP's levels of concern for methomyl in drinking water, as a contribution to
chronic aggregate exposure.
A linear methodology (Qj*) was applied for the estimation of human cancer
risk and was calculated to be 1.8-8 x 10"2. The assessment was conducted for
the total U.S. Population only. The upper bound cancer risk was calculated to
be 3.76 x iOy7. This upper bound risk is below the range the Agency considers
neglible for excess lifetime cancer risk and is not cause; for concern.
Occupational Exposure and Risk
Handlers (mixers, loaders, and applicators) of thiodicarb may be exposed to
thiodicarb during and after normal use of liquid and wettable powder
formulations. For dermal exposure, no short- and inteimiediate-term dermal
risk was:iiseen^^fgrthiodicarb.. For inhalation exposure, 'the Agency is requiring
the use of personal protective equipment and/or the use of engineering controls
(water soluble bags). The handier uiformation for thiodicarb has been
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integrated with other considerations, including the toxicity concerns pertaining
,.to methomyl, a degradate of thiodicarb, in determining the required PPE.
Environmental
Assessment
There are no short- or intermediate-term dermal endpoints of concern for
thiodicarb, and a post-application inhalation risk assessment is not warranted.
However, thiodicarb rapidly degrades to methomyl. Therefore, the toxicity
concern's pertaining to methomyl are considered jn the post-application risk
assessment. Based on the results .of this assessment, the Agency believes an
REI of 48 hours is sufficiently protective of workers following applications of
thiodicarb for the •currently registered uses.
Environmental Fate .
' . ' f' _ . . , '
Available environmental fate studies show that thiodicarb degrades rapidly into
methomyl under most conditions. While the parent chemical does not appear
to be very persistent or highly mobile, the degradate methomyl is more
persistent, more mobile, and more toxic. Thiodicarb rapidly degrades (half-
lives on the order of a few, days) primarily by metabolism and hydrolysis in
alkaline conditions. It may be more persistent under drier conditions.
Methomyl appears to be moderately persistent and highly mobile in the
environment. The dominant routes of dissipation are metabolism (biologically-
mediated degradation), leaching, and photolysis in clear waters.
While thiodicarb is not expected to have a high potential to contaminate
ground water because of its short persistence, methomyl has fate characteristics
that favor leaching, and it has been detected in ground water in a prospective
ground water monitoring study and in other reported incidences. While it may
reach ground water under certain conditions, methomyl may not persist under
many conditions. Both thiodicarb and methomyl may run off to surface waters
for a few days to several weeks after application. Neither chemical is likely to
persist in clear, shallow waters or in waters with substantial microbiological
populations. However, methomyl may persist in waters where sunlight
penetration is limited (such as in deeper waters or waters with a significant
sediment load or populations of organisms such as algae). Neither chemical is
expected to persist in anaerobic sediments. " s
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Ecological Effects
Laboratory studies show that thiodicarb is practically non-toxic to birds but
moderately to highly toxic to small mammals on an acute oral basis. Methomyl
is highly toxic to birds and mammals on an acute oral basis but only slightly
toxic to birds on a subacute dietary basis. Thiodicarb may result in chronic isks
to certain species that frequent short grass (e.g, ducks, geese and swans).
Methomyl, as a degradate, poses acute risks to birds and mammals that feed on
short and tall grasses, broadleaf plants, and small insects.
Acute toxicity studies show that thiodicarb is moderately to highly toxic to
freshwater and estuarine/marine fish, respectively, and very highly toxic to
freshwater and estuarine/marine invertebrates. The degradate methomyl is
moderately to highly toxic to freshwater fish and moderately toxic to estuarine
fish. In a chronic early life-stage study, methomyl significantly reduced fish
larvae survival under flow through conditions. Toxicity data suggest that
aquatic invertebrates are much more sensitive to methomyl contamination than
either fresh or salt water fish species. Accumulation of methomyl from
repeated applications contributes to the chronic risks. .
Ecological Effects Risk Assessment
EPA is generally concerned about the ecological effects to terrestrial wildlife
and aquatic organisms posed by exposure to thiodicarb. The risk assessment
for thiodicarb and its degradate methomyl shows various levels of concern
regarding avian risk and mammalian risk from multiple applications of
thiodicarb at short intervals. In addition, most agricultural uses present acute
and [chronic risks of yajying levels to endangered and nonendangered aquatic
organisms. The major concerns for non-target organisms are the chronic risks
posed by the use of thiodicarb to non-target mammaliEin and freshwater
invertebrate organisms! With .risk mitig
considers these risks acceptable.
•— j
Risk Mitigation
To lessen ecological and potential water risks posed by thiodicarb and its
degradate methomyl, the Agency is requiring the following mitigation for
thiodicarb containing products.
Thiodicarb will be reclassified as a Restricted Use Pesticide. (Thiodicarb
degrades rapidly to methomyl which is already a restricted use chemical.)
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• Based on the environmental risk assessment for methomyl, the following
advisories are required for thiodicarb: a labeling statement for potential
, ground water: contamination, a labeling statement to minimize the
potential for surface water contamination and labeling statements on
manufacturing use products and end use products based on the toxicity
to nontarget organisms. A bee hazard statement is also required.
. . • The maximum number of applications on cole groups will be reduced
- from 6 to 4 per season, at the maximum rate of 1^0 pounds ai/A. The
number of applications on cotton will be limited to 6.
' • . A statement supporting the use of an Integrated Pest Management (IPM)
plan must be added to the labels. - ,
-• Buffer zones have been imposed that will reduce the potential risk to
non-target aquatic organisms from spray drift during aerial or ground
applications. .-_,..
Additionally,: there are risk mitigation measures required in the RED to protect
mixers, loaders, applicators and workers, including water soluble bags,
- ' • . additional PPE and appropriate REIs. • For a detailed list, refer to Chapter V. of
the thiodicarb RED document.
, \
Additional Data The generic data base supporting the reregistration of thiodicarb for the above
Required eligible uses has been reviewed and determined to be substantially complete.
For thiodicarb, the following information is being required:
Product Labeling
81-8 Acute neurotoxicity study - rat ,
82-7. Subchronic neurotoxicity study - rat
72-4(a) Estuarine/marine fish early life stage test
72-4(b) Estuarine/marine invertebrate life-cycle tests
164-1 Field Dissipation Study (cotton and corn)
860.1500 Magnitude of residue in cotton (formerly 171-4k)
860.1900 Field Accumulation hi Rotational Crops (formerly 165-2)
830.7050 UV/Visible Absorption
Thiodicarb Cooking Study - - .'
All thiodicarb end-use products must comply with EPA's current
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Changes Required
Regulatory
Conclusion
pesticide product labeling requirements and with those labeling requirements
imposed in the Thiodicarb RED. For a comprehensive list of labeling
requirements, please see Section V. of the Thiodicarb Rj?f) document.
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"For More
Information
,
Based on the reviews of the generic .data for the: active ingredient
thiodicarb, the Agency has sufficient information on the health effects of
thiodicarb and on its, potential for causing adverse effects in fish and wildlife
and the environment. The Agency has determined that thiodicarb products,
labeled and used as specified in the Reregistration Eligibility Decision, will not
pose unreasonable risks to humans or the environment. Therefore, the Agency
concludes that products containing thiodicarb for all uses are eligible for
reregistration.
EPA is requesting public comments on tlie Kefegistration Eligibility
Decision (RED) document for thiodicarb 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, ^Washmgton,^ pC^^^t^^a^J^^^^ ' "" ..... '
Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/REDs.
Printed copies of the RED and fact sheet can be obtained from 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 Thiodicarb ]RED document also will
be available from the National Technical Information Service (NTIS), 5285
' Port Royal Road, Springfield, VA 22 1 6 1 , telephone 703 -605-6000. " '
/ „ , "' f -, ' ', ' '
For more information about EPA's pesticide reregistration program, the
Thiodicarb RED, or reregistration of individual products containing thiodicarb,
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 Pesticide Telecommunications Network (NPTN). Call toll-free 1-
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800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Time, seven
days a week. Their internet address is ace.orst.edu/info/nptn.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFRCEOF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
DEC 22-J9
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 thiodicarb. The
enclosed Reregistration Eligibility Decision (RED), which was approved on September 30, 1998,
contains the Agency's evaluation of the data base of this chemical, its conclusions of the potential
human health and environmental risks of the current product uses, and its decisions and conditions
under which these uses and products '.will be eligible for reregistration. The RED includes the data
and labeling requirements for products for reregistration. It also includes requirements for
additional data (generic) on the active ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the receipt of this
letter. The second set of required responses is due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of suspension
against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both pesticide law (FIFRA) and the food and 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
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
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RED.
H you have questions on the product specific data requirements or v/ish to meet with the
Agency, please contact the Special Review and Reregistration Division representative Bonnie
Adler (703) 308-8523. Address any questions on required generic data to the Special Review and
Reregistration Division representative Tom Myers (703) 308-8589.
Sincerely,
is A. Rossi, Direcror
Special Review and"^
Reregistrationi Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATIQN ELIGIBILITY DECISION
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted*a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) 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-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a foil
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"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the. other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling
.guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number 703-605-6000).
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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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have twooptions for 'submitting"aCSF: (1) acceptthe standard certified limits (see 40 CFR
§158.175) 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 §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back. • ,
e. Certification With Respect to Citation of Data and Data Matrix. Complete and
sign EPA forms 8570-34 and 8570-35 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL_KEJGISTJER_ NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT "SPECIFIC PCI "RESPONSES (90.DAYJ AND
APPLICATIONS FOR REREGISTRATIQN (8-MONTH RESPONSES!
BvU.S.Mail:
Document Processing Desk (TRED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.WI ' ;, : , ('
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRKD-PRB) -
Office of Pesticide^Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy!
Arlington^ yA 22202 ™ ^ i ' '•
6 EPA'S REVTEWS-rEPA 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 reregjstration determination within 14 months after the RED has been
issued.
!|l I I .Ill
1 Ill 11
111
" II
(III
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REREGISTRATION ELIGIBILITY DECISION
THIODICARB
LISTB
CASE2675
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
THIODICARB REREGISTRATION ELIGIBILITY DECISION TEAM ....... i
EXECUTIVE SUMMARY ........... , . .'. ..*.......:\....... .... .'. ..... .v
L INTRODUCTION . ... ........:.......... 1
H. CASE OVERVIEW . . . . . ... . 2
A. Chemical Overview 2
B. Use Profile.. .....;.; ; 2
C. Estimated Usage of Pesticide 5
D. Data Requirements 7
E. Regulatory History 7
.. • r J . •
IDT. SCIENCE ASSESSMENT . . .9
A. Physical Chemistry Assessment 9
B. Human Health Assessment =-..'..:..". 9
1. Toxicology Assessment ...... 10
a. Acute Toxicity 10
\ b. Subchronic Toxicity 11
c. Chronic Toxicity and Carcinogenicity ... . 13
d. Developmental and Reproductive Toxicity 16
e. Mutagenicity '. 17
f. Metabolism . 18
2. Dose Response Assessment 18
a. Potential Risk to Infants and Children and FQPA Safety Factor
- ......:...... .....; 18
b. Reference Dose 20
c. Carcinogenicity Classification and Risk Quantification .... 20
d. Toxicological Endpoints 21
3. Exposure Assessment 24
a. Dietary Exposure (food sources) '......' .24
b. Dietary Risk Assessment and Risk Characterization ....... 29
c. Aggregate Exposure 32
d. Drinking Water Assessment , 33
e. Cumulative Risk '..-:...' 34
4. Occupational and Residential r 35
a. Occupational and Residential Exposure 35
b. Occupational Risk (Non-Cancer) Estimates ............. 46
c. Occupational Cancer Estimates 47
d. Post-Application ,.. 47
e. Post-Application Risks 50
C. Environmental Assessment 52
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" 1. Toxicity to Terrestrial Animals . ... : 52
2. Toxiclty to Aquatic Animals ......... 55
3. Toxj-:^ ^-'pj^jj,' _"y_ _'_"_ _"7.'77.7. ."".. .V.':,.7 ."".". .'.7... 7. 760
D. Environmental Fate 60
1. Environmental Fate Assessment 60
2. Terrestrial Exposure Assessment . .. . 63
3. Water Resource Assessment 65
4. Aquatic Exposure Assessment 67
: E. Environmental Risk Assessment .. '.., _ 69
1. Exposure and Risk to Nontarget Terrestrial Animals 72
2. Exposure and Risk to Nontarget Freshwater and Marine Aquatic
Animals . ....... 77
3. Exposure and Risk to Nontarget Plants 80
4. Exposure and Risk to Endangered Species 81
5. Environmental Risk Characterization • : • s • • • : - - •,.*.*. •, 8,2
IV. RISK MANAGEMENT AND REREGISTRATION DECISION ,,, „ . ., ,. , ,,, 84
A. Determination of Eligibility 84
1 ' B. iSeterminatioiii oT&igibillty Decision 7."'.' ."." '. '.".'..'.".".'.'".".'".'.."'.'.". '.'•"".". ¥5'
1. Eligibility Decision . 85
2. Eligible and Ineligible Uses 7 . .".'" 85
C. Regulatory Position . 85
1. Food Quality Protection Act Findings 85
2. Tolerance Reassessment , 89
3. Summary of Risk Management Decisions . . . . . .... ...". . 92
4. Ecological Risk Mitigation for Thiodicarb . ". '. . . '.". . . . ! . 93
5, , Restricted Use Classification . .94
6. Endangered Species Statement 94
7. Labeling Rationale "."."!".".''.'!'".7."-;-. '. ".'.'. '. "7.7.7. ."777., .'.7'!.''. .95
|| I I I I | l| 11 II III IIIIIIM II I II I I Mllll III ° l»i"i , vir ,:i, , i », ,»' ,« - < ,<« : ./ ,,..i,.,r, n , , , < <" »",<,« h ,,,'i ,,„
8. Spray Drift Advisory 97
in in i inn in i in iiiiiiiiiii ni111 i 11 I ii i i i 11 11 i i mi 11
V. ACTIONS REQUIRED OF REGISTRANTS . . 7 . 98
A. Manufacturing-Use Products 98
1. Additional Generic Data Requirements , i 98
2. Labeling Requirements for Manufacturing-Use Products and End-Use
Products 99
B. Existing Stocks 110
"VI. APPENDICES ,,..,,,......;,.._......,., : .,....,,:,.: .111
A. Table of Use Patterns Subject to ^registration .. . 113
B. Table of the G-eneric Data Requirements and Studies Used to Make the
Reregistration Decision 133
C. Citations Considered to be Part ofthe.Data Base Supporting the Reregistration
Decision .,..,.,....., 143
D. Combined Generic and Product Specific Data Call-in 161
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1. Chemical Status Sheets 181
2. Combined Generic and Product Specific Data Call-In Response Forms
(Insert A) Plus Instructions 183
3. Generic and Product Specific Requirement Status and Registrant's
Response Forms (Insert B) and Instructions 188
4. EPA Batching of End-Use Products for Meeting Data Requirements for
Reregistration 200
5. List of AH Registrants Sent This Data Call-In (insert) Notice 203
E. List of Available Related Documents and Electronically Available Forms 204
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1 i!''!i,"•!!"' If ,,;>>|:lii I,"' 'i Jill" .ill Mil
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THIODICARB REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Steve Jarboe
Alan Halvorson
Science Information and Administration Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Larry Liu
NickFederoff
Nelson Thurman
Ann Stavola
Health Effects Risk Assessment
Felicia Fort
Linda Taylor
John Leahy
David Miller
Brian Steinwand
Registration Support Risk Assessment
Tom Harris
Risk Management
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Reregjstration Branch I
Reregjstration Branch I
Chemistry and Exposure Branch I
Chemistry and Exposure Branch II
Chemistry and Exposure Branch I
Ihsecticide-Rodenticide Branch
Tom Myers
Reregistration Branch II
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Ill II
i j 11 ill in in iin
I I
III
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct tenn for reference dose (RfD).
.AE Acid Equivalent
a.i. Active Ingredient . ,
ARC Anticipated Residue Contribution
CAS . Chemical Abstracts Service
CI Cation
CNS Central Nervous System ,
CSF Confidential Statement of Formula
DFR- Dislodgeable Foliar Residue '
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (D WEL) The D WEL represents a medium specific (ie. drinking
water) lifetime exposure at which adverse, non-carcinogenic health effects are not anticipated to
occur. , , . .„ ' .
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem. .
EP End-Use Product ,
EPA U.S. Environmental Protection Agency
FA0/WHO . Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration ."-•-.
FIERA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act ,
FOB Functional Observation Battery .
GLC Gas Liquid Chroniatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT . Highest Dose Tested
LCso Median Lethal Concentrau'oa 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.
LDso 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.
LD10 Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level "
LOC Level of Concern -
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration .
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
ug/g Micrograms Per Gram
Mg/L Micrograms per liter
mg/L Milligrams Per Liter .
MOE Margin of Exposure .
MP Manufacturing-Use Product
MPI Maximum Permissible Intake .
in
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Ill III 111 II I Illl
GLOSSARY OF TERMS AND ABBREVIATIONS
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A NotApplicable
NOEC No Observable Effect Concentration ': ^ \ M ™ ^"'_,','t, ","'"~r '^ _". "J" \'' i
NPDES National Pollutant Discharge Elimination System
NOEL, No Observed'Eifect Level ,
NOAEL No observed Adverse Effect' Level'" s ". ^ ' ''":_\\' _' "" __' ''^"" ^ _' _' __" "". ' , ''
OP Organophosphate
OPP Office of Pesticide Programs
Pa pascal, the pressure exerted by a force of one newtqn acting on an area of one square meter.
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessjngnl Guideline ^ i ih ri iir h. i i __ ,
PAM1 Pesticide Anah/tical'Metnod '
PHED .Pesticide Handler's Exposure Data
PHI PreharvestInterval. • ' ,_: :. ., ' . \' \
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Miliiion "
PRN pesticide Registration Notice
Q*i The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide .
SLN Special Local Need (Registrations Under Section 24© of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD T^oxic Dose. Ths dose at which a substance produces a toxic effect.
TEP Typical End-Use Product •
TGAI Technical Grade Active Ingredient
TLC ThinLayer Chromatography
TMRC Theoretical Maximum Residue Contribution
ton: A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP Wettable Powder .
WPS Worker Protection Standard
11 in i i i in ii i iiiii n i n ii i ' ii i i '
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EXECUTIVE SUMMARY
Background , , .
This Reregistration Eligibility Decision (RED) document addresses the reregistration
eligibility of the pesticide thiodicarb, dimethyl N,N'-(thiobis((methylimino)carbonyloxy))
bis(ethanimidothioate). Thiodicarb is used primarily on cotton, sweet corn, and soybeans. The
remaining usage is spread among leafy vegetables, cole crops, ornamentals, and other minor use
sites. Thiodicarb acts as an insecticide against major Lepidopterous, and suppresses Coleopterous
and some Hemipterous insect pests. Thiodicarb acts as an ovicide against cotton bollworms and
budworms.
Thiodicarb was first registered in the United States in 1984 for use as an insecticide. In
April, 1991, the Agency issued a Phase IV Data Call-In for thiodicarb requiring additional studies
on ecological effects, environmental fate, residue chemistry, and human toxicity. <
Reregistration Eligibility .
EPA has completed its reregistration eligibility decision of the pesticide thiodicarb. This
decision includes a comprehensive reassessment of the required target data and the use patterns of
currently registered products. This decision considered the requirements of the "Food Quality
Protection Act of 1996" (FQPA, Public Law 104-170) that amended the Federal Pood Drug and
Cosmetic Act and the Federal Insecticide, Fungicide and Rodenticide Act. These are the two
Federal statutes that provide the framework for pesticide regulation in the United States. FQPA
became effective immediately upon signature and all. reregistration eligibility decisions signed after
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. ^
In determining whether to retain, reduce, or remove the lOx FQPA safety factor for
infants and children, EPA uses a weight of evidence approach taking into account the
completeness and adequacy of the toxicity data base, the nature and severity of the effects
observed in pre- and post-natal studies, and exposure. Although the data provided no indication
of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to thiodicarb, data .
gaps exist for the acute and subchronic neurotoxicity studies. These studies would have yielded
chplinesterase inhibition and field observation behavior data, as well as histopathology of the
central and peripheral nervous system which are not presently available for evaluation. The
Agency determined that the lOx safety factor to account for increased sensitivity of infants and
-------
children should be reduced from lOx to 3x. Regarding aggregate exposure, the Agency only
considered dietary exposure from food and water because there are no homeowner uses of
thiodicarb.
The Agency has determined that thiodicarb has a metabolite, methomyl, which is also a
registered pesticide. Therefore, methomyl residues resulting from applications of both thiodicarb
and meJiomyl were considered in an aggregate dietary risk assessment and compared to
'appl^nate^toxicojo^ical endpoints for methomyl. In addition, for post application exposure to
workers, the methomyl short and intermediate-term dermal endpoints were used in the risk
•; \'2; : •;:;,,;::::;' SSs^gjffSit becgyse jhipdjcarb degrades rapidly to methomyl.
!••'• !";<':»" .;' "IIIIBi;.W,\'":'.':
'JfiTh/'Irb: !
f'ji'ljl'iiijj'llllliif KijM' IHS8I, , SHMiS! I! ill
iiil'
'.jj,,,, "i' IIJ!1!^ JT ,,,11,^ Jiililiniiraii'Siljlili!' JVICM Mil ..... l!l!ill!';ii;i,'l1l!ilL.i|l!l!ii|ii«';:jiiiitiil'"l||i,ri;iiK|l!i; MinitHL'']!'!™,,! Ill I I I III P I 1 1 II III I I I I I I I I I I
;*:..5|i li;;^: iTge Agency does not have, at this time, available data to determine whether thiodicarb has
j"™'1':™ ' T !f cOpmoime|h^ other substances or how to include this pesticide in a
lliiiH of this assessment, therefore, the Agency has not
i ...... mm ...... *j;J
...... ......
The Agency has determined that thiodicarb, labeled and used as specified in this
Reregistration Eligibility Decision document, will not cause unreasonable risks to humans or the
eavlrowment andiat these uses are eligible for reregistration. The Agency is requiring additional
data for toxicology, ecological effects, and residue chemistry that are expected to confirm the risk
assessment.
Health Effects
Thiodicarb has been classified as a Group B2 - probable human carcinpgen. The B2
classification was based on statistically significant increases in hepatocellular adenomas,
carcinomas, and combined adenoma/carcinoma in both sexes of the mouse sind statistically
significant increases in testicular interstitial cell tumors in male rats.
A linear methodology (Q!*) was applied for the estimation of human cancer risk and was
calculated to be1.88_x .10?. The assessment was conducted for the total U.S. Population only.
Cancer exposure is estimated by multiplying the Ch* (1.88 x 10 "2) by the chronic dietary
exposure (0.000020 mg/kg/day). This chronic dietary exposure utilized both anticipated residue
and percentcropi>t^e^Tn^6nnation.' Theupper'bdund'cancer'nskwas1cai''Culate1dto1b"e3!76"x
10"7. This upper bound risk is below the range the Agency considers neglible for excess lifetime
cancer risk and is not cause for concern.
The RfD for thiodicarb was calculated to be 0.03 mg/kg/day from a chronic rat toxicity
study with a NOEL of 3.3 mg/kg/day for males and 4.5 mg/kg/day for females. The RfD was
based on an increased incidence of extrarnedullary hemoppiesis in males and decreased KBC
cholinesterase in females at the LOEL. An uncertainity factor of 100 was used for deriying the
RfD and includes 10x for inter-species extrapolation and lOx for intra-species variation. An
FQPA safety factor of 3x (due to data gaps) was applied to derive an FQPA adjusted RfD of 0.01
VI
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mg/kg/day. Exposure must be less than 100% of the FQPA adjusted RfD -to be considered below
EPA's level of concern.
For acute dietary risk assessment for thiodicarb alone, a MOE of 1000 is required for
women 13 years and older, as well as for the general population including infants and children.
This MOE includes the conventional MOE of 100 for inter- and intra-species variation, 3x for
FQPA, and another 3x for the use of a LOEL, instead of a NOEL, in the critical study. The
FQPA Safety Factor (3x) is required because of data gaps (acute and siibchronic neurotoxicity
studies).
\ • •
The results of the Monte Carlo acute dietary exposure analyses, for thiodicarb alone,
indicate that there are adequate margins of exposure for the general U.S. population
(MOE=2450), women 13 years and older (MOE=2100), children 1 to 6 years of age
(MOE=2900), and infants (MOE=1680). The Monte Carlo acute analyses incorporated a 93%
decline in methomyl residues in cabbage following cooking, an average decline of 75% in celery
following trimming of celery tops, anticipated residues and percent crop treated information.
For the acute aggregate dietary risk assessment for food, for thiodicarb and methomyl
combined, the endpoint for methomyl was used in the risk assessment and compared to residues
of methomyl from thiodicarb application plus residues of methomyl from methomyl application.
A MOE of 300 is required for women 13 years and older, as well as for the general population
including infants and children. This MOE includes the conventional MOE of 100, and another 3x
for FQPA. The FQPA Safety Factor (3x) is required because of data gaps (acute and subchronic
neurotoxicity studies). The results of the acute aggregate exposure analyses for food, for
thiodicarb and methomyl show that there are adequate margins of exposure for the general U.S.
population (MOE=912), children 1 to 6 years of age (MOE=417) and infants (MOE=756). This
analysis used a Monte Carlo simulation which included anticipated residues and percent .crop
treated information for all commodities.
The results of the chronic dietary risk evaluation system (DRES) analyses, for thiodicarb
alone, indicate that the anticipated residue contribution for the U. S. Population occupies 68% of
the FQPA adjusted RflD. For females (13 years and older) 67% of the FQPA adjusted RfD is
occupied. For children (1 to 6 years old) and infants, 104% and 43%, respectively, of the FQPA
adjusted RfD is occupied. Although for children (1 to 6 years old), the FQPA adjusted RfD is
slightly exceeded, if more refined estimates of dietary exposure were made (e.g. residues from
field trials) significantly lower chronic risk would be estimated. Therefore, the chronic risk from
exposure to thiodicarb from food sources is not of concern.
For the chronic aggregate dietary risk assessment for food, for thiodicarb and methomyl
combined, the RfD for methomyl was used in the risk assessment and compared to residues of
methomylfrom thiodicarb application plus residues of methomyl from methomyl application.
Results of the chronic aggregate exposure analyses for food, for thiodicarb and methomyl,
vn
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show that the most significantly exposed subpopulatipn is infants (<1 year old) with 6.5% of the
Rfl) occupied. For children 1-6 years old 2.7% of the RfD is occupied For the general U.S.
population, only 1 .9% of the RfD is occupied. For this aggregate exposure analysis, anticipated
residues arid percent crop treatec! information were utilized for all of the approximately 70
commodities. There are no chronic concerns associated witii potential residues of methomyl on
foods as the result of application of thiodicarb and methomyl.
........................................ . n " ' ..... ' ' '
Thiodicarb degrades rapidly to methomyl in the environment. Therefore, the Agency has
calculated ^r^n^watCT levels i of for methomyl. Acute exposures in surface
and grouiutwater fOT'thVtLSL popula^onTanci 'children ..... (1-6 years) ....... ^"47'o"and"56 ppb,
respectively. For chronic (non-cancer) exposure to methomyl in surface and ground water, the
drinking water levels of concern are 275 and 78 ppb for the U.S. population arid children (1-6 yrs
old), respectively.
Estimated maximum (acute exposure) concentrations of methomyl in surface and ground
Water are 30 and 20 ppb, respectively. The estimated average (chronic exposure) concentration
of methomyl in surface water is 26 ppb. Average concentrations in ground water are not
expected to be higher than the maximum concentrations. The maximum estimated concentrations
of methomyl in surface and ground water are less than the Agency's levels of concern for
Hull I i I INI ..... , .............................. < ..... I .......... .................. ,i;i, ..... II ...... ................. ...... < ....... ilSutll .......... , ................................ , .............. ill' ........ h, ...... ,, ........ , ..... , .............. <: i, I, ..... i ........... ' ............... ...... nl. ........ i .......... ...II ......... || ........... TM|N,' ........ •„ r?ni [[[ i .............................. . ....... ............ . ...... ..<« .................... .................... i
methomyl in drinking , water __as a contribution to acute aggregate exposure. The estimated average
concentrations of methomyl in surface and ground water are less than OPP's levels of concern for
methomyl in drinking water as a contribution to chronic aggregate exposure.
mi 1 1 1 1 1 1 1 n ili ;; i =': iii ,;• ^SJwfcwTiJfcia'i w IS T wHJ*'1*'^';. ;t: i ^iAiBStitrii s'« , ;i JiS ; :5>2jl Cviiii i-: |:i>: " si: y ^iiK;1','.' ."iS < wwiiiw" 55?wi \
J Therefpr,e, the Agency concludes that aggregate exposure to all sources of thiodicarb and
m,ethomyl does not exceed the Agency's risk concerns.
To minimize the 'risks of potential systemic toxicity to mixers/loaders and other handlers
the Agency is requiring the use of personal protective equipment and/or the use of engineering
controls (water soluble bags).
Environmental Fate and Ecological Effects
»
........ ; ...................................... | .................... i ......... '! .......................
Available environmental fate studies show that thiodicarb degrades rapidly into methomyl
under most conditions. While the parent chemical does not appear to be very persistent or highly
mobile, the degradate methomyl is more persistent, more mobile, and more toxic.
• • in i i i i n i i i in L If
Chronic laboratory studies show that thiodicarb is moderately to highly toxic to small
mammals and will result in chronic risks to certain species of avians that frequent short grass (e.g.
ducks, geese and swans). Methomyl, the primary degradate for thiodicarb, is very highly toxic to
mammals and poses acute and chronic risks to mammals that feed on short and tall grasses,
broadleaf plants, and small insects. In summary, thiodicarb poses potential chronic risks to birds
and mammals, primarily due to the build-up of the degradate methomyl from multiple applications
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Acute and chronic toxicity studies show that thiodicarb is very highly toxic to freshwater
invertebrates. Toxicity data on the degradate methomyl suggest that methomyl is also highly
toxic to aquatic invertebrates on an acute and chronic basis. Both thiodicarb and its degradate
methomyl can present high acute risk to freshwater invertebrates.
/• • • - > • " -
The major concerns are chronic risks to non-target avian, mammalian, and freshwater
invertebrate organisms. Risk to non-target mammalian and freshwater invertebrate organisms
have been addressed by limiting the maximum number of applications of thiodicarb on cole crops
to 4 per season at the maximum rate of 1.0 Ibs ai/A. Currently, the maximum of 6.0 Ibs ai/A
equals a total of 6 applications at the maximum rate per season. The number of applications on
cotton will be limited to 6. These measures will result in less loading of thiodicarb and its degrate
methomyl in the environment. Reductions in risk to non-target aquatic organisms is also expected
from measures that reduce the potential for spray drift during aerial or ground applications.
These restrictions include buffer zones. All agricultural products containing thiodicarb are being
reclassified as restricted use pesticides: In addition, label statements are required to minimize the
potential for ground water and surface water contamination. A statement supporting the use of
an Integrated Pest Management (IPM) plan and a bee hazard statement will also be added to the
labels.
, f , '
Product Reregi strati on
Before reregistering the products containing thiodicarb, 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 toxicity testing. After reviewing these data and any
revised labels and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the
Agency will reregister a product. 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. ~
IX
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•illn i ii1 it ii i i iinil
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I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregistration of products with active ingredients registered prior to November 1,
1984. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data, to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") 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 Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170) was signed. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7
U.S.C.136 el seq. The FQPA amendments went into effect immediately. As a result, EPA is
embarking on an intensive process, including consultation with registrants, States, and other
interested stakeholders, to make decisions on.the new policies and procedures that will be
appropriate as a result of enactment of FQPA. This process will include a more in depth analysis
of the new safety standard and how it should be applied to both food and non-food pesticide
applications. The FQPA did not, however, amend any of the existing reregistration deadlines in
section 4 of FIFRA. The Agency will, therefore, continue its ongoing reregistration program
while it determines how best to implement FQPA. ,
This document presents me Agency's decision regarding the reregistration eligibility of the
currently registered uses of thiodicarb. The document consists of six sections. Section I is the
introduction. Section n describes thiodicarb, 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 thiodicarb. Section V discusses
the reregistration requirements for thiodicarb. Finally, 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.
1,
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H. CASE OVERVIEW
A. Chemical" Overview - ' . . ' ^ ' ]
The following active ingredient is covered by this Reregistration Eligibility
' Decision:, , , ' •
• Common Name: Thiodlcarb
• Chemical Name: dimethyl N,N1-(thiobis((meth>'limino)carbonyloxy))
bis(ethanimidothioate)
• Chemical Family: Carbamate
• CAS Registry Number: 59669-26-0
• OPP Chemical Code: 114501
i iii i in M iiiini iiiiiii h INI 11 ii ill ii1 i hi 'i n i ii in iiy n i in ]\iim mill1 . 111
• Empirical Formula: C10H18N4O4S3
i i i i ii i i i i
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|l!i;ii , lulu 7 liii'lil'll!" .Ini!!1:!1!1'! nlllil-iliii'';'!!!'''!!;':!!! ".I jIHIil/^iMiLEi'ilKl,' ,:n' lUIUl! "1 IWIillW'Tri'lllll!!1,i,'fii'1!1!'!:'! 1 Ill'UUvIl,,II11!V i" ,"Z, '':! : ',.;:''. illrlll'TAIIMV':!1 . Inl :"'llllil I 'Miflirthii;1 ^v"1!,"!'tfi'l' ijl" .! '„. JVHEOil MiiiVJ""1", 'fi,'IS!ill0,!';,i'"!;,,'IT,"',i'"I'l'lilL1,,:, :• "f"i M::!n"t ^..li!1; ,1.1 I<1 T- llt'ill1;,;;!*1,'Ji'"'!!''!!
• Basic Manufacturer: Rhone-Poulenc AG Company
The following is information on the currently registered uses with an overview of
use sites and j^p¥cauon mJethodsV Ad'etat'led'table of'tiiese uses of gjlQjjp^ -g -^^^ •-
in Appendix A.
Type of Pesticide: Carbamate insecticide and mofluscicide
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Use Sites:
v _ - - >.
TERRESTRIAL FOOD CROP
broccoli, cabbage, cauliflower, corn (sweet), cotton, leafy vegetables, soybeans
TERRESTRIAL FEED CROP
cotton, leafy vegetables
TERRESTRIAL NON-FOOD CROP
agricultural rights-of-way/fencerows/hedgerows, agricultural uncultivated areas,
rights-of-way/fencerows/hedgerows, nonagricultural uncultivated areas/soils, citrus
fruits (non-bearing), tree nuts (non-bearing), pome fruits (non-bearing), stone
fruits (non-bearing), ornamental herbaceous plants, ornamental nonflowering
plants, ornamental woody shrubs and vines, ornamental and/or shade trees
GREENHOUSE NON-FOOD CROP
ornamental herbaceous plants, ornamental nonflowering plants, ornamental woody
shrubs and vines, ornamental and/or shade trees
FORESTRY
shelterbelt plantings
Target Pests:
Invertebrates (insects and related organisms, molluscs, fouling organisms and
miscellaneous invertebrates) including: alfalfa looper and larvae, armyworm and
larvae, bagworm, beanleaf beetle and larvae, beet armyworm and larvae, boll
weevil and larvae, bollworm and larvae, Rown garden snail, budworms, cabbage
flea beetle and larvae, cabbage looper and larvae, cankerworms, corn earworm and
larvae, cotton boll weevil and larvae and eggs, cotton leaf perforator and larvae,
cotton leafworm and larvae, cutworms and larvae, diamondback moth and larvae,
european corn borer, fall armyworm and larvae, fall cankerworm and larvae, fall
webworm fleahoppers and larvae, fruittree leafroller, gray garden slug, green
cloverworm and larvae, gypsy moth, heliothis caterpillars and larvae, imported
cabbageworm and larvae, leafrollers, loopers, mexican bean beetle and larvae,
mimosa webworm, oakworms, omnivorous leafroller, pink bollworm and larvae,
plant bugs and larvae, podworms and larvae, sawflies, skippers, slugs, snails,
southern armyworm and larvae, soybean looper and larvae, spring cankerworm,
spruce budworm, stink bugs and nymphs, tent caterpillars, three cornered alfalfa
hopper and larvae, tobacco budworm and larvae, tomato fruitworm and larvae,
velyetbean caterpillar and larvae, webworms, western bean cutworm, woolybear
caterpillar and larvae, yellowstriped armyworm and larvae.
3
-------
Registered: '
Teddnical grade (gg<^man^^^ng product ^5%^ end use product (L75% to
80%); liquid (unspecified, 90%, 96%), flowable concentrate (23.6%, 34%),
granular (4%), pelleted/tableted (1.75%), water dispersible granules (dry flowable,
Methods and Rates of Application:
Types of Treatment: Broadcast; Chemigation; Directed spray; High volume spray
(dilute); Low volume spray (concentrate); Spray
Equipment: Aircraft; Ground (both high and low volume); Sprayer; Sprinkler
irrigation
Rates: See Appendix A
in in
Timing: For use on in-ground, containerized and/or non-bearing nurserystock.
Silk and whorl stages for sweet corn. For use on a "when needed" basis for
cotton, soybeans, and tomatoes as long as preharvest intervals are complied with.
Use Practice Limitations; (these do not apply to all uses on all products)
Do not apply directly to water, or to areas where surfacewater is present or to
interddal areas below the jnga|}l|igh water mark.
Do not contaminate water, food or feed.
in f "i*
Do not discharge effluent containing this pesticide into sewage systems without
notifying the sewage treatment pj—^^-^ ^^^
Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public water (NPDES license restriction).
Do not feed treated corn silage 'or fo dd^ to'livestock!
Do not store or use jntor around Jhe honae, ojjiome garden.
For terrestrial uses, do not apply directly to water or to areas where surface water
is present or to intertidal areas below the mean high water mark.
,i, '» Slim' „ ,,i <„, , ,,,'< , i< n'jr MMII .'.'i, | « , I. in,,, ' '" , '•< *ri: ,
Site/Application Limitations: (these apply to specific methods and rates of
application)
Dp not graze livestock in treated areas.
Do not feed treated foliage to livestock or graze treated areas.
Do not feed treated forage or hay to livestock.
Do not feed to livestock.
Do not harvest or feed hay to livestock.
Do not graze treated areas.
Do not use for feed or forage.
Do not feed treated corn silage or fodder to livestock.
Do not use for food or feed.
,„,; 'J:liiii1i "„, y ill;: ,
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day(s) or hours preharvest interval. (For example: 12 hours or 0, 7, 14 days)
C. Estimated Usage of Pesticide
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D. Data Requirements
In addition to data requirements imposed to obtain the original registration of this
active ingredient, data were required in the reregistratipn Phase IV Data Call-In issued in
April of 1991. Data required included studies on ecological effects, environmental fate,
residue chemistry, and human toxicity. Appendix B includes all data requirements
identified by the Agency for currently registered uses_which are required to support
reregistration.
E. Regulatory History
Thiodicarb products were first registered under the tradename Larvin by Union
Carbide in 1984 and transferred to Rhone-Poulenc in 1987.
Methomyl is a degradate of thiodicarb. In August 1997, a reassessment of all
tolerances for thiodicarb was completed in order to make a decision on certain time-
limited tolerances which were due to expire. This analysis included both the residues from
all thiodicarb uses as well as residues from application of methomyl. All tolerances were
found to be satisfactory and made permanent. Subsequently, changes to the toxicological
dietary endpojnt have resulted in significant changes to the risk assessment. These
changes are reflected in the dietary sections of this document.
The table on the following page shows the major registration actions for
thiodicarb.
-------
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HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The following figure shows the chemical structure of thiodicarb.
Thiodicarb [dimethyl N;N-(thiobis((methylimino)carbonyloxy))
bis(ethanimidothioate)]
o
I "
CH,
O
-CH,
Empirical Formula:
Molecular Weight:
CAS Registry No.:
OPPCodeNo.:
C10H18N404S3
354.46
59669-26-0
114501
Identification of Active Ingredient
Thiodicarb is a white to light tan crystalline powder with a slight sulfurous odor
and melting point of 168-174°C. Thiodicarb is soluble in water at 35 ppm, and in
dichloromethane, acetone, methanol, and xylene at 15%, 0.8%, 0.5%, and 0.3% by
weight, respectively.
Manufacturing-use Products
There are two thiodicarb manufacturing-use products (MPs) registered to Rhone-
Poulenc AG Company, under OPP Code No. 114501: the 96% technical (T; EPA Reg.
No. 264-343) and the 90% formulation intermediate (FI; EPA Reg. No. 264-411).
"Product Chemistry Data Requirements
All pertinent generic and product-specific product chemistry data requirements are
satisfied for the Rhone-Poulenc 96% T/TGAI, except for GDLN 830.7050j»ertaining to
UV/VIS absorption spectrum. This guideline is required. In addition, the registrant must
certify that the suppliers of beginning materials and the manufacturing process for the
thiodicarb TGAI have not changed since the last comprehensive product chemistry
reviews or submit a complete updated product chemistry data package.
B. Human Health Assessment
-------
1, Toxicology Assessment
The available toxicological database for thiodicarb is adequate and will support a
reregistration, eligibility determination. An acute neurotoxicity study (81-8) and a
subchronic neurotoxicity study (82-7) are required.
a. Acute Toxicity
The following table presents the results of the acute mammalian toxicity studies
conducted with technical thiodicarb:
Table 3 - Acute Mammalian Toxicity Studies
Route
Oral
Dermal
Inhalation
Eye Irritation*
Skin Irritation*
Dermal Sensitization1
Acute Delayed Neurotoxicity
Species
Rat
Rabbit
Rat
Rabbit
Rabbit
Guinea Pig
Hens
Results
LDs<, (m) = 46.5 mg/kg
LD™ (fl — ^9 1 me/leg
LDso >2000 mg/kg
LCjo (m) 0.13, (1) 0.12 mg/L
and > 0.32 mg/L for dust
Slight Irritant
No Irritation
Weak Sensitivity
Negative
Tox Category
I
m
n
in
IV
N/A
N/A
* Not required for TG AI, however, presented here for informational purposes.
In several acute oral toxicity studies with rats, the LD50 ranged from 46.5 mg/kg
for males and 39.1 mg/kg for females, which is Toxicity Category I, to 398 mg/kg for
males and 248 mg/kg for females, which is Toxicity Category n (MRID 00025791,
OQli5604, 00115607). In a mouse study, theLDso was 73 mg/kg in males and 79 mg/kg
in females (MRID 43784501).
The LDso in an acute dermal toxicity study with rabbits was found to be greater
than 2000 mg/kg. This is Toxicity Category ffl (MRID 44025501).
In an acute inhalation toxicity study with rats, the LC50 for males was 0.13 mg/L,
for females 0.12 mg/L, and greater than 0.32 mg/L for dust for both sexes. These results
are all considered to be in Toxicity Category H (MRIDs 00041432 and 00045467).
Thiodicarb is a Toxiciry Category in primary eye irritant in irabbits. Instillation
resulted in slight irritation (MRID 44025502).
10
-------
Thiodicarb produced no irritation during the primary dermal irritation study in
rabbits, placing thiodicarb in Toxicity Category IV for skin irritation (MRID 44025503).
Thiodicarb induced a weak dermal sensitization reaction in guinea pigs (MRIDs 41891004
and43373201). ,
An acute delayed neurotoxicity study with thiodicarb in atropine-pretreated hens,
using a dose level of 660 mg/kg (LDSO) was negative (MRIDs 00044961 and 00053253).
' No data are available on the acute and subchronic neurotoxicity of thiodicarb in rats.
Although no neurotoxic signs rjer se have been observed in the various studies performed
using thiodicarb to date, thiodicarb is a carbamate, and confirmatory acute and subchronic
neurotoxicity studies are required for a thorough investigation of this parameter.
b. Subchronic Toxicity
The following table summarizes the results of the sub-chronic toxicity studies for
thiodicarb.
Table 4 - Summary of Thiodicarb Sub-Chronic Toxicity Studies
GLN#
82-2
82-2
82-2
82-2
82-2
82-2
82-2
82-2
Type of Study
13-week dietary - rat
13-week dietary - dog
6-month dietary - dog
21-day dermal - rabbit1
16-day dermal - rabbit1
9-day inhalation -tat
4-week dietary - mice
28-day dietary - rat
NOEL
mg/kg/day
3
15
15
1000
1000
not determined
6.2 males
8.3 females
10
LOEL
mg/kg/day
10
45
45
2000
4000
4.8
mg/m3
346 males
491 females
30
Toxic Effects
decreased body weight gain, KBC
cholinesterase activity and hemoglobin
decreased RBC parameters
increased liver weight and SGPT
macrocytic anemia, erythema, and edema
decreased body weight, erythrocytes and
hemoglobin
pinpoint pupils and tremors at LDT "
increased liver weight in females and
increased spleen weight in both sexes
decreased plasma and RBC cholinesterase
activity
1 The NOELs from these studies were used for short term and intermediate term dermal occupational
toxicological endpoints.
In a subchronic toxicity study, Fisher 344 (COBS CD F/Crl BR) rats,
10/sex/group, were administered thiodicarb (97% a.i:) via the diet at dose levels of 1, 3,
10, and 30 mg/kg/day for 13 weeks. The NOEL was 3 mg/kg/day, and the LOEL was 10
mg/kg/day, based on decreased body-weight gain, decreased RBC cholinesterase activity,
11
-------
and decreased hemoglobin (MRID 00044965).
In a subchronic feeding study in Beagle dogs, thiodicarb wais administered via the
diet at dose levels of 0, 15, 45, and 90 mg/kg/day for 13 weeks. The high dose was
lowered to 76 mg/kg/day in females after day 36 due to the deaths of 2 high-dose females.
The NOEL was 15 mg/kg/day, and the LOEL was 45 mg/kg/day, based on decreased
KBC parameters (RBCs, hematocrit and hemoglobin) in both sexes (MRID 00044966).
In anothersubchrpnic; toxicily study in dogs, thiodicarb was; administered via the
diet at dose levels of 0, 5,15, and 45 mg/kg/day for 6 months. The NOEL was 15
mg/kg/day, and the LOEL was 45 mg/kg/day, based on liver effect!} of increased serum
glutamic pyruvic transaminase (SGPT) and increased liver weight (MRID 00079474).
Li a 21-day dermal toxicity study, New Zealand White rabbits were administered
thiodicarb via the skin at dose levels of 1000, 2000, and 4000 mg/kg/day for 6 hours a
day, 5 days a week for 3 weeks. The NOEL was 1000 mg/kg/day, and the LOEL was
2000 mg/kg/day, based on macrocytic anemia, erythema, and edema (MRIDs 00043737
and 00044967).
Li a 16-day dermal toxicily study, New Zealand white rabbits were administered
thiodicarb via the skin at dose levels of 1000 and 4000 mg/kg for 6 hours a day, 5 days a
weekforS consjcutive^weeks. TheNOEL.was lOOp.mg/kg/day, and the LOEL was 4000
mg/kg/day, based on decreased erythrocytes, decreased hemoglobin, and decreased body
weight (MRID 00043738).
In a 9-day dust inhalation study, Sprague-Dawley rats were administered
thiodicarb particulates via the inhalation route at dose levels of 0,4.8,17.7, and 59.5
mg/m3 for males, and 0,4.8, 19.6, and 54.0 mg/m3 for females (mean measured
atmospheric concentrations) for 6 hours a day for 9 days. A NOEL could not be
determined. At 4.8 nig/m3, two clinical signs typically associated with choliriesterase
effects (pinpoint pupils and tremors) were observed in both sexes. There were no
significant body-weight effects at this dose level in either sex, and no statistically
significant effects were observed in any cholinesterase measurement (plasma, RBC, and
brain) at 4.8 or 17.7/19.6 mg/m3 in either sex (MRIDs 00045467 and 00053252).
In a 4-week feeding study, CD-I mice of both sexes were administered thiodicarb
via the diet at dose levels for males of 0, 6.2, 346, 734, and 1538 mg/kg/day, and for
;'rf«m~ales'15FO, O~ 491, 954,'and 203G| ^g/j^gy f ™^ —^ — NOEL w&g g 2 ^ g 3
mg/kg/day for males and females respectively. The LOEL was 346 and 491 mg/kg/day for
r'~:fflii§§ anl;;;]fem:^e§,:,respectiyely:i These results are'based on increased liver weight in
females and increased spleen weight in both sexes (MRID 43611701).
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12
-------
thiodicarb via the diet at dose levels of 0, 1, 3,10, .and 30 mg/kg/day for 28 days. The
NOEL for effects on cholinesterase activity was 10 mg/kg/day, and the LOEL was 30
mg/kg/day, based on decreased plasma and RBC cholinesterase activity (MRID
00098292).
c. Chronic Toxicity and Carcinogenicity
Thiodicarb is classified as a B2 (probable human) carcinogen (HED Cancer Peer
Review Committee, document dated June 10,1996). The B2 classification was based on
statistically significant increases in hepatocellular adenomas, carcinomas, and combined
adenoma/carcinoma in both sexes of the CD-i mouse and statistically significant increases
in testicular interstitial cell tumors in male Sprague-Dawley rats.
The table on the following page summarizes the results of the
chronic/carcinogenicity toxicity studies for thiodicarb.
13
-------
11 1 1
fable 5 - Summary of Thiodicarb Cbronic/Carcinogenicity Toxicity Studies;
GLN#
83-l(b)
83-1 (a)
83-l(a)
83-l(a)
Type of Study
1-year chronic -
dog
same study
2-year chronic/
carcinogenicity-
rat1-2-
97-week
carcinogenicity-
mice2
2-year mouse
carcinogenicity
NOEL
mg/kg/day
4.4 males
4.5 females
12.8 males
13.8 females
3.3 males
4.5 females
70
3
LOEL
mg/kg/day
12.8 males
13.8 females
38.3 males
39.5 females
12 males
15 females
1000
10
Toxic Effects
Cholinesterase inhibition
Systemic effects based on reduced
hematology parameters
Systemic effects based on increased
incidence of extramedullary hemopoiesis in
males and decreased RBC ctiolinesterase in
females. High-doise males displayed an
increased incidence of interstitial cell
tumors in the testes compared to the
concurrent control males. There were no
compound-related tumors observed in the
females.
Increased mortality, clinical chemistry,
liver and spleen weights; and incidences of
kidney, liver, and spleen lesions, and
decreased hemoglobin, hematocrit, and
erythrocytes. There were increased
incidences of hepatocellular tumors in both
sexes.
Mortality in females.
1The NOEL from this study was, UE^ *° ^PPkte.$*?. t^1!9^c^ E??ele,5ce dose 0*1%
uncertainly factor" oflb'Oi ", ,
2 The toxic effects from this study were used to determine the B2 cancer classification for thiodicarb.
Beagle dogs were administered technical thiodicarb via the diiet at dose levels of 0,
4.4,12.8, and 38.3 mg/kg/day for males at dose levels of 0,4.5,13.8, and 39.5 mg/kg/day
for females, for one year. The NOEL is 4.4 mg/kg/day for males and 4.5 mg/kg/day for
females. The LOEL is 12.8 mg/kg/day for males and 13.8 mg/kg/day for the females,
based on cholinesterase inhibition. The systemic NOEL is 12.8 mg/kg/day for males and
13.8 mg/kg/day for females. The systemic LOEL is 38.3 mg/kg/day for males and 39.5
mg/kg/day for females, based on reduced hematology parameters including erythrocytes,
hemoglobin, and hematocrit (MRID 00159813).
i ^ „ ^ ii|iirii|r, , iir In a chronic toxicity_/carcinpgenicity study, Spra.gue-Da.wley rats were
administered g5o2fcarb via the diet at dose levels of 6,3.3,12, and 60 mg/kg/day for
males and dose levels of 0,4.5,15 and 80 mg/kg/day for females-for 104 weeks.' The
systemic NOEL was 3.3 mg/kg/day for males and 4.5 mg/kg/day for females. The LOEL
was 12 mg/kg/day for males and 15 mg/kg/dayfor females, based on the increased
incidence of extramedullary hemopoiesis in males and decreased RBC cholinesterase in
14
-------
females. There were no compound-related tumors observed in the females. The high-
dose males displayed an increased incidence of interstitial cell tumors in the testes
compared to the concurrent control males, and the incidence was also greater than the
historical control (MRIDs 43308201,43405001,43596401).
In a carcinogenicity study, Charles River CD-I mice of both sexes were
administered thiodicarb via the diet at dose levels of 0, 5,70, and 1000 mg/kg/day for 97
weeks. The NOEL was 70 mg/kg/day, and the LOEL was 1000 mg/kg/day, based on
decreased body-weight gain in males, and in bom sexes toxic effects noted consisted of
increased mortality; decreased hemoglobin, hematocrit, and erythrocytes; increased alanine
aminotransferase and total bilirubin; increased liver and spleen weights; and increased
incidences of kidney, liver, and spleen lesions. There were increased incidences of
hepatocellular tumors in both sexes. In both male and female mice, there were statistically
significant increases in hepatocellular adenomas, carcinomas and combined
adenomas/carcinomas at the highest dose (1000 mg/kg/day). There were also statistically
significant positive dose-related trends for adenomas and carcinomas, alone and combined.
The incidence of adenomas and carcinomas at the highest dose exceeded that of historical
controls in both sexes; in addition, in male mice, the incidence of adenomas at the mid-
dose (70 mg/kg/day) exceeded that of historical controls (MRIDs 43000501 and
43619301).
In another carcinogenicity study, Charles River CH:COBS CD-L (ICR)BR mice of
both sexes were administered thiodicarb via the diet at dose levels of 1, 3, and 10
mg/kg/day for 104 weeks. The NOEL was 3 mg/kg/day, and the LOEL was 10
mg/kg/day, based on mortality in females (MRID 00041407).
Other Carcinogenurlssues
Methomylis a metabolite of and is structurally-related to thiodicarb. Methomyl
was classified as a Group E, not likely to be carcinogenic to humans via relevant routes of
exposure (HED/RfD/ Peer Review Committee document dated October 25,1996). There
are two animal metabolites acetamide and acetonitrile. Acetamide, a metabolite of
methomyl, has been evaluated by the the Agency and classified as a Group C, possible
human carcinogen. However, after a thorough investigation, the Agency concluded that
the ingestion of methomyl and acetamide in the diet should not represent a significant
carcinogenic hazard to the consuming public based on the following: 1) the conversion
rate of methomyl to acetamide is low, approximately 2-3 percent, therefore, residue levels
of acetamide in edible meat should be low, 2) carcinogenicity studies with methomyl ha
two rodent species indicated no increase in any type of tumor under the test conditions, 3)
the product is comprised of 98.7 percent syn-isomer and 0.092 percent anti-isomer, syn-
isomer must be converted to anti-isomer before acetamide is'formed, and 4) acetamide
induced liver tumors in rats only when administered at very high dosages, i.e. more than
1000 mg/kg/day. Ingestion of acetonitrile from application of thiodicarb and/or methpmyl
15
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.not represent_a _si^ficaiit carcinogenic hazard because it is volatile, residues are
small, it has little or no cancer potential, and since it is a rat metabolite its toxicity was
accounted for in the toxicity studies.
d. Developmental and Reproductive Toxicity
The following table summarizes the results of the developmental and reproductive
toxicity studies for thiodicarb.
Table 6 - Summary of Thiodicarb Developmental and Reproductive Toxicity Studies.
GLN£
83-3(a)
83-3(b)
83-3(a)
83-4
Type of Study
developmental -
rat1
developmental -
rabbit
f
developmental -
mice
2-generation - rat
NOEL
mg/kg/day
maternal;
N/A
developmental;
N/A
maternal;
20
developmental;
40, HOT
maternal;
100
developmental;
200, HOT
reproductive;
5
systemic;
5
LOEL
mg/kg/day
maternal
10
developmental
10
maternal;
40
maternal;
200
reproductive;
15
systemic;
15
Toxic Effects
Decreased body weight gain.
Decreased fetal body weights and
increased incidence of litters and fetuses
with developmental variations.
Decreased body weight gain and food
consumption.
Increased mortality.
Decreased fetal body weight and
viability.
Decreased body weight/ gain and food
consumption.
1 1 he LOELs from this study were used for the acute dietary endpoint.
In a rat developmental toxicity study, pregnant Charles River CD COBS rats were
administered thipdicarj:) via gayage on gestation days 6-19 at dose levels of 0 [0.5%
methocefj, 10,20, and 30 mg/kg/day. Maternal toxicity was observed at the 20 and 30
mg/kg/day dose levels, as evidenced by inactivity, tremors, and a clesar oral discharge
observed for 1-4 hours post dose. Negative body-weight gain was observed during the
first 3 days of dosing at the mid- and high-dose levels, and overall body-weight gain was
decreased at all dose levels [81%, 73%, and[65% of'cantio[atlO? 20, and 30 mg/kg/day,
respectively].
Developmental toxicity was observed at all dose levels. There was a dose-related
decrease in fetal body weight [89%, 75%, and 69% of control at 10,20, and 30
16
-------
mg/kg/day, respectively] that was statistically significant at all dose levels. Inhere was a
dose-related increase in the number of litters and fetuses with developmental variations
[unossification of the hyoid, sternebrae #5 and/or #6 and other sternebrae], and increases
hi reduced ossification of the skull and vertebrae, and unossification of the pubis and entire
sternum were observed at the 20 and 30 mg/kg/day dose levels.
The maternal LOEL is 10 mg/kg/day, based on decreased body-weight gain. The
developmental LOEL is 10 mg/kg/day, based on decreased fetal body weight and an •
increase in the number of litters and fetuses with developmental variations. No NOEL
was established for either maternal or developmental toxiciry (MRID 099223).
In a developmental toxicity study, artificially-inseminated New Zealand white
rabbits were administered thiodicarb via gavage on gestation days 6 through 19 at dose
levels of 0 (vehicle 0.5% aqueous methylcellulose), 5,20, and 40 mg/kg/day. The
maternal toxicity NOEL was 20 mg/kg/day, and the maternal toxicity LOEL was 40
mg/kg/day, based on reduced body-weight gain and food consumption. The
developmental toxiciry NOEL was 40 mg/kg/day, the highest dose tested (MRIDs
00159814, and 40280001).
In a developmental toxiciry study, Charles River CD-I mice were administered
thiodicarb on gestation days 6 through 16 via gavage at dose levels of 0 (vehicle 0.5%
methocel), 50,100, and 200 mg/kg body weight/day. The maternal toxicity NOEL was
100 mg/kg/day, and the maternal toxicity LOEL was 200 mg/kg/day, based on increased
mortality. The developmental toxicity NOEL was 200 mg/kg/day, the highest dose tested
(MRIDs 00043742, 00043743, 00053257, 00053258).
In a two-generation reproduction study, Crl:CD®BR/VAF/Plus® rats were fed
doses of 0,5,15, and 45 mg/kg/day of thiodicarb. The reproductive/developmental
toxicity NOEL is 5 mg/kg/day, and the reproductive/developmental'toxiciry LOEL is 15
mg/kg/day, based on decreased fetal body weight and viability. The systemic NOEL is 5
mg/kg/day and the systemic LOEL is 15 mg/kg/day, based on decreased body weight/gain
and food consumption in both sexes (MRIDs 42381301,42381302,42735101).
e. Mutagenicity
Thiodicarb did not induce a mutagenic response in the Ames assay, with or
without metabolic activation (MRIDs 00044872, 00135792). Thiodicarb induced dose-
related increased mutant frequencies in mouse lymphoma TK+'~ cells, with and without
metabolic activation and is considered to have an equivocal weak effect in the mouse
lymphoma forward mutation assay (MRID 00151574). Thiodicarb,'with or without
metabolic activation, did not cause a clastogenic response in the chromosomes of Chinese
hamster ovary cells (MRID 00151572). Thiodicarb is considered inactive in theprimary
rat hepatocyte unscheduled DNA synthesis assay (MRID 00151573).
17
-------
I lillilllllll ll Illlllllllllllllllllllllllllllllllllllllllllllll I 111 III
f.
Metabolism
Metabolic studies were -performed in i rate using single low and single high doses of
radiolabeled thiodicarb. The major routes of elimination were expiration (CO2 and
acetonitrile) and urination. Tissue residues contained 7-9% of the dose at 7 days post
dose and may reflect the metabolism of "C-aicetonitriie into the body's C-2 and C-l pools
and subsequent interaction with, or incorporation into natural products. The major
. terminal metabolites of thiodicarb in the rat are CO2 and acetonitrile. The major urinary
metabolite isaikbileimji^^_i£at represents 50% of the urinary radiolabel. No
acetamide was detected in any of the tissues. The Rg^s contained only residue that
cannot be extracted by organic solvents or water, indicating the presence of radiolabel
incorporated into natural products or of material tightly bound to hemoglobin (MRID
41250006,41250007).
In a metabolism study in monkeys, some tbiodicarb [syn, sym-isomer] radiolabel
was converted via in vivo metabolism to syn-meiipmyl and subsequently isomerized to
^:__......_^ .g^_._£.™__ to"2.^3.3% (upper limiit) by weight of
thiodicarb being converted to acetamide and excreted in the urine (MRIDs 4266760 1
43228901).
..... \\'2. ................................ Dose Response Assessment
.................................. [[[ : .............................. a, .............................. Potential .Risk to Infants and Children and FQPA Safety
Factor .
In determining whether to retain, reduce, or remove the 1 Ox FQPA safety factor
for infants and _ children, _ EPA uses; a weight of evidence approach taking into account the
completeness and-adequacy of the toxiciry data base, the nature and iseyerity of the effects
observed Jflpre- and post-natal studies, exposure, and other information such as
epidemiological data. •
For purposes of assessing the pre- and post-natal toxicity of tbiodicarb, EPA has
evaluated three developmental and one reproduction study. The effects observed hi the
thiodicarb developmental and reproduction studies are summarized in Table 6, section
[[[
The Agency has determined that the data provided no indication of increased
susceptibility of rats or rabbits to in utero or postnatal exposure to thiodicarb. In the
prenatal developmental toxicity studies in rats and rabbits, effects in the fetuses were
-------
parental animals (NOEL =5 mg/kg/day), it was concluded that this is not a real indication
of increased susceptibility for the following reasons: 1) the endpoint (decrease in pup body
weight) was considered to be a systemic effect and not a developmental or reproductive
effect since the decrease was seen from day 7 through 21 of lactation in male pups and
from day 14 through 21 in female pups; 2) the decreased pup weight was seen only in one
generation (F2b) and not in the other generations thus lacking in consistency in response;
3) the data showed that the body weight gain of pups in this litter was at a higher rate than
the body weight gain of control pups; 4) the decrease (8%) in both sexes on day 0 was not
statistically significant at day 4; 5) the lowest dose (5 mg/kg/day) is actually considered
close to a NOEL for the offspring while the 1.75 mg/kg/day was derived using Bench
Mark methodology; and 6) it is during the latter portion of lactation that pups consume
approximately twice the diet per unit body weight as an adult rat and, because of the
availability of the test material to the pups from both milk and the feed, the amount
consumed by the pups is likely more than double the adult's.
There are, however, data gaps for acute and subchronic neurotoxicity studies in
rats. These studies are considered data gaps because thiodicarb breaks down to
methomyl, which has exhibited neurotoxic signs in two species (dogs and rabbits) by two
different routes of exposure (oral and dermal). In addition, thiodicarb produced
neurotoxic effects (tremors and inactivity in dams) in the rat developmental toxicity study
as well as tremors in rats in a 9-day inhalation toxicity, study. The requirement for a
developmental neurotoxicity study in rats is in reserve status pending receipt of the acute
and subchronic neurotoxicity studies. ' ,
Uncertainty Factor
The lOx FQPA Safety Factor for enhanced sensitivity to infants and children (as
required by FQPA) for thiodicarb was reduced to 3x.
Although, there was no indication of increased susceptibility of rats or rabbits to in
utero or postnatal exposure to thiodicarb, data gaps exist for acute and subchronic
neurotoxicity studies. These studies will provide cholinesterase inhibition and field
observation behavior data as well as histopathology of the central and peripheral nervous
system which are not available for evaluation in any of the available toxicology studies on
thiodicarb. Thiodicarb is not currently registered for any residential uses. The 3x safety
factor and the use of generally high quality data and conservative models and/or
assumptions in the exposure assessments provide adequate protection of infants and
children.
The FQPA Safely Factor (3x) should be applied for acute and chronic dietary risk
assessments for the general population including infants and children. Application of the
FQPA Safety Factor is appropriate for these risk assessments because of the lack of data
on the neurotoxic .potential of thiodicarb following single and repeated exposures.
19
-------
b.
Reference Dose
An RfD (exclusive of the 3x FQPA safely factor) was calculated to be 0.03
mg/kg/day based on a chronic rat toxicity study with a NOEL of 33 mg/kg/day for males
and 4.5 mg/kg/day for females (RfD Peer Review Committee; JaniKiry 18,1996). The
LOEL was 12 mg/kg/day for males and 15 mg/kg/day for females, based on the increased
incidence of extramedullary hemopoiesis in males and 'decreased"jQajc"choMnesterase' in
females (MRID 43308201). An uncertainty factor of 300 was used and includes lOx for
inter-species extrapolation, lOx for intra-species variation and an FQPA safely factor of 3x
(J>as.edonthedata gaps). The FQPA adjusted RfD is 0.01 mg/kg/day. Exposure must be
less than 100% of the pQp^ adjusted RfD to be considered below EPA's level of concern.
Thiodicarb has been reviewed by the WHO/FAO Joint Meeting on Pesticide
Residues, and an Acceptable Daily Intake of 0.03 mg/kg/day was established.
^ * i
ih
c. Carcinogenicity Classification and Risk Quantification
The carcinogenic potential of Thiodicarb was evaluated by the HED Cancer Peer
Review Committee (CPRC) on November 29, 1995 prior to issuance of the draft
guidance, Proposed Guidelines for Carcinogen RjskAssessment of April 1996. The
CPRC classified it as a Group B2 - Probable Human Carcinogen based on the evidence of
carcinogenicity in both sexes of mice (liver tumors) and male rats (testicular tumors) and
recommended a non-linear approach (i.e., Margin of Exposure) for human risk
characterization. The CPRC determined that extrapolation should be based On the
combined hepatocellular adenomas/carcinomas in male mice.
The CPRC recommended the MOE approach in part based on the fact that liver
tumors were observed only at the high dose (1000 mg/kg/day) which is the Limit-Dose for
carcinogencity testing and this dose may have been excessive due to the significant
hepatoxicity seen in both sexes of mice at this dose level. Pronounced systemic toxicity
that manifested as increased mortality (females), significant decreases in body weight gain
(males), and alterations in the hematopoietic system (both sexes) was also observed at the
high dose. Due to the poor dose selection, the increase in liver tumors observed in males
at the nextlower dose (70 mg/kg/day) could not be discounted. Additionally, testicular
tumors were observed hi male rats only at the high dose with a borderline significance.
There is no evidence of genotoxicity.
The Agency's Proposed Guidelines for Carcinogen Risk Assessment of April 1996
states that for human risk characterization, a linear default would be used unless the
chemical was non-mutagenic and had a non-linear mode of action. Although Thiodicarb is
non-mutagenic, no studies demonstrating a mode of action for the induction of liver
tumors have been submitted to the Agency. Therefore, Thiodicarb did not meet one of the
two criteria specified in the guidelines for using a non-linear approach for human risk
20
-------
characterization.
Based on these factors, the Agency has determined that a linear (Qj*) instead of
the non-linear (MOE) approach is appropriate for human risk characterization at this time,
This decision is primarily due to the lack of mode of action studies which are required for
use of a non-linear approach as specified in the Draft guidelines of 1996.
d. lexicological Endpoints
The following endpoints were selected for risk assessment (Health Effects
Division's Toxicological Endpoint Selection Committee; document dated June 14,1996).
Dermal Absorption
There are no dermal absorption data available. A study could not be identified.
The NOEL of 20 mg/kg/day from the oral developmental toxicity study in rabbits was
compared to the NOEL of 1000 mg/kg/day from the 21-day dermal toxiciry study in
rabbits (MRIDs 00043737 and 00044967). This indicates an estimated dermal absorption
of approximately 2%. This estimation of low dermal absorption is supported by the lack
of systemic toxiciry in the 21-day dermal study. This estimate was used in the
occupational risk assessment for cancer.
Acute Dietary (1 day) Females 13 Years and Older
The endpoint selected for this risk assessment is the developmental LOEL equal to
10 mg/kg/day, based on decreased fetal body weight and an increase in the number of
litters and fetuses with developmental variations. This endpoint is applicable only for the
females 13 years and older subgroup. For acute dietary risk assessment for thiodicarb
alone, a MOE of 1000 is required. This MOE includes the conventional MOE of 100 for
inter- and intra-species variation, 3x for FQPA, and another 3x for the use of a LOEL,
instead of the NOEL, hi the critical, study. The FQPA Safety Factor (3x) is required
because of data gaps (acute and subchronic neurotoxicity studies).
Acute Dietary (1 day) General U.S. Population, Including Infants and Children
The endpoint selected for this risk assessment is the maternal LOEL equal to 10
mg/kg/day, based on decreased body-weight gain. This endpoint is applicable for the
general population including infants and children. For acute dietary risk assessment for
thiodicarb alone, a MOE of 1000 is required for the general population including infants
and children. This MOE includes the conventional MOE of 100 for inter- and intra-
species variation, 3x for FQPA, and another 3x for the use of a LOEL, instead of the
NOEL, in the critical study. The FQPA Safety Factor (3x) is required because of data
gaps (acute and subchronic neurotoxicity studies).
21
-------
Ill (II
ill i ' I' I ill ' , 11 i i ' i '
f
Carcinogenic Exposure (Dietary and Occupational')
A Ql* of 1.88 x 10 -2 (mg/kg/day)-l based on evidence of earcinogencity in both
sexes of mice (liver tumors) and male rats (testicular tumors) will be used for estimating
carcinogenic risk. Carcinoginic risk is estimated for adults only.
ininiiL 'Hi'1,11 ii "if .'i i, ii si id, ',,n i viii i ii i II||''|IIIIII|||IIIIIIL i ,i i1,,'1.1 imiiri IP; iiiirwi I'liiiilini» iii"! IIIPII ' i, '.i iiniiiwi'i''!!' "i '"ipnv iw JN;!, , "I'liiininpi;,,,11'1,!!!'! i : ? >' i, >' iiii11!;:11 ', ,;,'ii HI, i< ,» i;;1 n; ',' 'nil iHi'Mi.'i,,1',!'1"!,!:;',! 117
Short Term Dermal Occupational or Residential Exposure (1-7 davs^
Short term or intermediate term dermal occupational and residential risk
assessments are not required. No appropriate endpoint was identified. No treatment-
related effects were observed at 1000 mg/kg/day in a 16-day repeated dose dermal toxicity
study in rabbits (MRID 00043738). No dermal or systemic toxiciry was observed at 1000
mg/kg/day ma 21-daydermal toxiciry studyin rats (j^f)00044967).
Intermediate Term Dermal Occupational or Residential Exposure (I week to several
months')
See Short Term exposure (above).
Chronic Occupational or Residential Exposure (several months to lifetime^
Chronic dermal occupational or residential exposure toxicity endpoints were
identified for thiodicarb. However, based on the current use patterns, chronic exposures
to thiodicarb are not expected, and a chronic risk assessment is not necessary. The
Agency believes that a reasonable worst-case frequency of exposure would be six days per
week for 2 - 3 months for harvesters working in crops where thiodicarb use is common.
For nursery and greenhouse workers engaged in cultivation of herbaceous and woody
ornamentals, a reasonable worst case frequency of exposure would be intermittent
exposures of 2 - 3 weeks at a time, several times per year, but not continuous. This is
representative of intermediate-term rather than chronic exposure.«
Inhalation Occupational or Residential Exposure fanv time period')
Assuming-100% inhalation absorption, the LOEL to be used for risk assessment
for thiodicarb is 0.0048 mg/L, based on a 9-day dust inhalation study in rats (MRIDs
00045467 and 00053252). This was the lowest dose tested in this study. A NOEL could
not be determined. The effects seen at the LOEL, of pinpoint pupils and tremors, are
clinical signs typically associated with cholinesterase effects. These effects were observed
in both sexe§? Using the calculations shown below for route-to-route extrapolation to
calculate dose, the LOEL is 1.2 mg/kg/day.
••in i n inn in i mi i ii • mi •• i inn i i i L, INI i i i i 1 11 n i i inn in »¥ i
4.8 mg/m3 is equal to 0.0048 mg/L because mg/m3/! 000 = mg/L
22
-------
LOEL = 0.0048 mg/L; route to route extrapolation given by [0.0048 mg/L/day x 1 (for
100% inhalation absorption) x 8.46 L/hr x 6 hr exposure x 1 (for activity factor)/0.190 kg]
= LOEL of 1.2 mg/kg/day.
An uncertainty factor of 3x is required since a LOEL was selected for use in this
risk assessment instead of a NOEL. An MOE of at least 300 is required for acceptable-
occupational inhalation risks. ,
v r - ...
Methonivl Toxicological Endpoints of Concern
The Agency has determined that thiodicarb has a metabolite, methomyl, which is
also a registered pesticide. Therefore, methomyl residues resulting from applications of
both thiodicarb and methomyl will be considered in an aggregate risk assessment and
compared to appropriate toxicological endpoints for methomyl.
- • .''.''•• , •''
The RfD for methomyl was established based on a 2-year dog
feeding/carcinogenicity study with a NOEL of 2.5 mg/kg/day. An uncertainty factor of
100 was applied to account for both inter-species extrapolation and intra-species
variability. The IQx FQPA safety factor to account for enhanced sensitivity to infants and
children was reduced to 3x. The 3x results from the lack of acute and subchronic
neurotoxicity studies. On this basis, the RfD was calculated to be 0.008 mg/kg/day.
The acute dietary endpoint for methomyl is the developmental NOEL of 6
mg/kg/day from a rabbit developmental study based on deaths in dams on days 1-3 after
dosing with methomyl at 16 mg/kg/day.. Because of the severity of effects observed,
exposure to all population subgroups are of concern (MRID 00131257). For acute
dietary risk assessment for application of thiodicarb and methomyl, an MOE of 300 is
required for the general population including infants and children. This MOE includes the
conventional MOE of 100 for inter- and intra-species variation, and 3x for FQPA. The
FQPA Safety Factor (3x) is required because of data gaps (acute and subchronic
neurotoxicity studies).
On plants, thiodicarb degrades to methomyl following application, yielding field
residues of methomyL Therefore, the Agency has considered potential worker exposure
to methomyl following applications of thiodicarb. There are short- and intermediate-term;
and chronic toxicological endpoints of concern for methomyl (Hazard ID Document dated
March 3, 1998). The NOEL for both short- and intermediate-term occupational risk
assessment for methomyl is 90 mg/kg/day based on no statistically or biologically
significant differences in plasma or RBC cholinesterase inhibition at the dose tested.
Because chronic risk to methomyl following applications of thiodicarb is not expected,
chronic exposure is not considered. Also, although an inhalation endpoint for methomyl
of 0.137 mg/L was identified, no post-application inhalation exposure assessment for
methomyl as the result of thiodicarb applications has been performed since the vapor
23
-------
pressures of both methomyl and thiodicarb are in the range of 1 X 10'5 mm Hg, which is
below that which would create an inhalation concern once sprays and dusts have settled.
3. Exposure Assessment
M!''
M ..... ' ................ *
• ii, lllllH "KiJ'I'i'H'iili-'JIl'l 'i.'i.nllilllh tl
X ':; -f Ka'&ffi1^;!, j :SS' .Sri"™ ....... '' ..... LT!Diefauy Exposure (food sonrees)
IIIH ..... S!;Wi:a2H
1 • JL > PS HUHIU; |;l i If';' , ' |i« , ; '' J ' ||;i: < » MMK, ' V ' ;: , SlL ill I'ilj^ |M| ;!«»' lUj ;• B;, ; ' N, I , ' llljjjjjjji ,„'!" jljtt :!; j Jhh '" Vijjjj ffpF > fcu %:[j||ij|jj[ I, !{jjjjj|;!!!jjjjjjjjjl i,]1' ;» ;;' *'; ;»!«. j| ; 'i ,,' IjwJ ;J Jjl] J; |;, »' )' '| .J ], '" LU :,'• ;;;; f ;;/ ;"! J ^ "jrf }f JSjri ' jj' ijlAIS'' !. JH|II;J| ;|: f ]*•[!* ': ^ / "'if'*;" f j "";;*'' !, !»:» J llf ! '| j||* ";;,;;'' *!' , ':!| L "i, "' '<> ;>, W ..... ''' »f: <
*"' '' ........ ' ""'" ..... """ ...... ' ..... '" ......... " ........... ................ ""' ....... ..... '"'
ril •I its i illilllllti'Miiil^
, , ,
sted ™r/'Summary of {Science Findings" .(below) outlines the
Science Assessments with respect to the reregistration of thiodicarb.
":» ..... ofthisdicarb ...... are currently expressed in terms of thiodicarb
and its metabjpjite methomyl, in/on plant raw agricultural commodities (RACs) [40 CFR
[[[ ' ''
S.i W!S';;??i ; 'Hi1 i;' ;;: ' •? 1
The Agency has determined that residues of acetamide and acetonitrile resulting
from the application of thiodicarb or methomyl are not residues of concern in animals and
will not be regulated (See discussion under B.l.c. "Chronic Toxicity and
Carcinogenicity"). The residues of concern in plants and animals are thiodicarb and its
metabolite methomyl. The chemical names and structures of the thiodicarb residues of
in MM nm HUP iniinii HIM iiiiiiiiiiiiiiiiiiiin j •,•!•, 1.11 11 • ' , ' '
concern are depicted rn the table below.
Table 7 - Thiodicarb and i
methomy
Common Name/Chemical Name
Thiodicarb
dimethyl N^SF'-
(thiobis((methyHmino)carbonyloxy))
bis(ethanimidothioate)
Methomyl
S-methyl N[(methylcarbambyl)oxy]
thioacetimidate
Chemical Structure
O
O
-CH,
CH3
C)
Tolerances on plant commodities range from 0.2 ppm for soybeans to 35 ppm on
leafy vegetables. In addition, a temporary tolerance of 150 ppm has; been established for
thiodicarb residues on sweet corn forage under 40 CFR § 180.31. Food/Feed additive
tolerances have been established for thiodicarb residues in soybean hulls (0.8 ppm) and
in," i; in'i;,-!1!1!«!'; ;• 'i."
(•"I vNHJiii iHi; ,ii;!!l!
•Mm i fit; ilia •;.<;•«r ~ liiiii itwi-iii1"*' :',"t ,« v ; ',*i!Tr liiii"!?; ".n't w > ~ ».i
f life' ft, „!."! i!ii|(! "i !|'"i 1 Tisll!, Ul'i'f tlt'fj'iv,'" if, 'lii'if'' iJI1!"!,}: I1!:1 v!: J!. J- J'-B Jt&Glfi *" 'ii
. ' tv i vf> "s '^i
X MW^lWnr .IM.VMWr'lW^^'i''' ^ !*!:T;?T
»V. IP1.,"''!:,,!11!! Lilfl'MllllWlll'l , ! 'ftifa;! "Vlll ilil'llhlll h M:,,""I| ' , 'Wl !' i.
'I!1.'! PKLt; !', 'glii'llll!;. f ',? l!l ••lillllnlhrlijlil l.'IT" >:i'T! iiilM":'1',! t"f':Z '.:,li !'llTnil1''lllii'T!!1!!:!:,
,.
nil i iiiiiii in n i n n in IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIMI|IIIII iiiiinii|iiiiiiiiiii iiiiiii n 11 nil
-------
cottonseed hulls (0.4 ppm) [40 CFR §186.5650], Adequate methods are available for the
enforcement of established tolerances, as currently defined.
The Agency has updated the Livestock Feeds Table [Table 1 in the Residue
Chemistry Test Guidelines, OPPTS Series 860, August 1996]. Additional residue data are
now required for some commodities as a result of these changes. These data requirements
have been incorporated into this document.
Summary of Science Findings
OPPTS GLN 860.1200 (Tormerlv 171-D: Directions for Use ",
_ There are six registered thiodicarb end-use products (EPs) with food/feed uses.
All are registered to, Rhone-Poulenc Ag Company. These are presented below.
EPA Reg No.
264-341
264-378
264-379 *
264-406
264-407
264-530
Label Acceptance
Date
. 7/88
5/96
5/96
11/88
12/88
5/96
Formulation
.Class
75.2% WP
80%WDG
3.21b/galFlC
3.2lb/galFlC '
2.11b/galFlC
80% WDG
Product Name
Larvin® Thiodicarb Insecticide 75 WP
Larvin® DF Thiodicarb Insecticide/Ovicide
Larvin® 3.2 Thiodicarb Insecticide/Ovicide
Larvin® SC Thiodicarb Insecticide
Larvin® 250 Thiodicarb Insecticide . . s
Larvin® DF WSP Thiodicarb Insecticide/Ovicide
a Includes SLN Nos. AL940004, CT890001, DE870002, GA870004, LA860006, MD880003, ME910006,
MI860005, MS860002, NC860002, NH920002, NJ920001, NY860002, OH890005, PA870004, PR910001,
RI950001, VA870005, and V.T920002. , -
Directions for use are acceptable except that label directions for sweet com should
be amended to remove the restriction specifying'use for "Florida Fresh Market Only" and
to remove the restrictions against grazing of livestock in treated fields or the feeding of
treated corn silage or fodder to livestock. Label directions for sweet corn should also
specify a maximum use rate of 7.5 Ib ai/A for the entire season, rather than just after silk
initiation as is currently specified. Once label directions for sweet corn are amended, the
19 SLN labels for the use of thiodicarb on sweet corn can be canceled.
OPPTS GLN 860.1300 formerly 171-4a): Nature of the Residue in Plants
The qualitative nature of the residue in plants is adequately understood based on
. soybean, tomato, cotton, sweet corn and peanut metabolism studies. The residues to be
regulated in plants are thiodicarb and its methomyl metabolite.
OPPTS GLN 860.1300 ^formerly 171-4K): Nature of the Residue in Livestock
25
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The qualitative nature of the residue in animals is adequately understood based
Upon acceptable ruminant and poultry metabolism studies. The residues to be regulated in
livestock are thiodicarb and its methomyl metabolite.
in in i mi i 11 ii ii nun n i in 111 n in in 11 i i n muni i in n i i in i i n i 11 in i I in i1!' In i • i mi i i i n i i s i i i j i i mi n i
OPPTS GLN 860.1340 rformerlv 171-4c.d>: Residue Analytical Methods
Adequate analytical methodology is available for data collection and enforcement
of tolerances for thiodicarb. Method I in the Pesticide Analytical Manual (PAM), Vol. II,
is a GLC/sulfur specific flame photometric detector (FPD-S) method that has undergone a
successful EPA method validation pn soybean meal. This method involves extraction with
acetpnermethanol (90:10, v/v), an acetonitrile:hexane partition, and a base hydrolysis of
thiodicarb and methomyl residues to methomyl oxime. Acidified residues of methomyl
oxime are then partitioned into methylene chloride and determined by GLC/FPD-S. The
reported limit of detection is 0.02 ppm for plant commodities.
. '
An enforcement analytical method for livestock^commodities is not necessary. The
^^jggjj ^a| |gere |s no reasonable expectation of gnfte thiodicarb residues in
ruminant commodities [180.6(a)(3)]. Therefore, no tolerances will be required for
livestock commodities.
OPPTS GLN 860.1360 ^formerly171-4m1: Multiresidue Method Testing
Th^lgAreSTDATA debase dgtej|j^&:(Pam Vol. I, Appendix I) indicates
that thiodicarb is partially recovered using FDA Multiresidue Protocol A (PAM I Section
242.2) and methomyl is completely recovered using FDA Multiresidue Protocols A and D
(PAM I Sections 242.2 and 232.4).
11 n i in i i iiiii n i i ii 11 in i 11 n n i iiiiiii' i'lfSI jiiKb ^^li£lihiLAf v&t!:£':ii'l!i\ifillti'iriK '+ iJ ii;.!'; :i i'.ii4»H*fi«iili ii iSiiiifi •• (iiilWkHi.tiHW JVi'Ki'il1;'"':: T; 'liiiri in > . (WWimW |
OPPTS GLN 860.1380 rformerlv 171-4&): Storage Stability Data
i ' i i i i i
Requirements for storage stability data are satisfied for purposes of reregistration.
Adequate storage stability data have been submitted for meat and miilk and RACs and
processed commodities of soybeans, cottonseed, and sweet corn. The storage stability
data for plant cprnmodjties M that thipdicarb and melipmyl are reasonably stable at
s-15 C in soybeans, soybean processed commodities, cottonseed, and cottonseed
processed commodities (except meal) for at least 12 months. Thiodicarb and methomyl
are stable at s-15 C for at least 3 months in cottonseed meal, sweet corn (K+CWHR), and
sweet corn forage/cannery waste. Data are also available indicating that residues of
iw^^»; *.«>£.,-•:;.—•! ssjiaifejjSdjjg^ fS^iSSlllPJPy^ are stable i*1 frozen apples for up to 14 months. These data
=;i^ storage intervals and conditions of all previously submitted plant
=j-[= studies and no additionai storage stability data for these studies
i' I; !4=j?'-? i' :••:".' ii" ii-iilli" required.
iiiiiin^ri ;ii;»i,iiTi RW' vi»';,;; i ;:,«•« ii;;;i ...i1,,,,;1 "MI/M i»i;,, > * 11 i r in mill • in in in
The storage stability data for animal commodities indicate that thiodicarb and
•L1!! iiw" p'lii'iiiiiiiin Ufa1 < iiiii. ' iiiiii ii ii IB, 11 'a, wi!" njTiiiii! .' ii i 11111 mi i ii 11 ii i i i i 111 i ii ip 11111 ni| ii [in 11 ii 11 i ii ii i i i 111 iiinnnn iiiiniiiii i
!!;" :;!,:""""! """||1"",;:1!" ""!:'!:,! ,','"!" "'":'. "26
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methomyl are stable at -20 C for up to -2 months in milk, muscle, and fat. In kidney,
thiodicarb and methomyl are stable at -20 C for up to 43 days, but declined by -40% after
69 days. Residues of thiodicarb and methomyl are not stable in liver. Within 2 days of
storage at -20 C, residues of thiodicarb and methomyl were nondetectable (<0.1 ppm) in
liver samples initially fortified with each analyte at 1 ppm. The available data adequately
support the Agency's conclusion that there is no reasonable expectation of finite
thiodicarb residues in ruminant commodities [180.6(a)(3)].
OPPTS GLN 860.1500 (formerly 171-4&: Magnitude of the Residue in Crop Plants
For purposes of reregistration, requirements for magnitude of the residue data
in/on plants are fulfilled for the following crops: broccoli, cabbage, cauliflower, leafy
vegetables (excluding Brassica), soybeans, and sweet corn. Adequate field trial data
depicting thiodicarb residues following applications made according to the maximum or
proposed use patterns have been submitted for all these commodities, except sweet corn
fodder. The registrant did not submit residue data for sweet corn fodder; nevertheless,
the Agency can calculate an appropriate tolerance for fodder based on a forage-to-fodder
dry matter correction factor.
Although adequate field trial data have been submitted for the above^listed
commodities, label modifications are required for several of these commodities to reflect
use patterns for which adequate residue data are available (see OPPTS GLN 860.1200:
Directions for Use). Geographical representation is adequate and a sufficient number of
trials reflecting representative formulation classes were conducted.
As a result of the update to the Livestock Feeds Table (Table 1 in the Residue
Chemistry Test Guidelines, OPPTS Series 860, August 1996), additional magnitude of the
residue data are required on cotton gin by-products.
OPPTS GLN 860.1520 (formerly 171-4D: Magnitude of the Residue in Processed
Food/Feed
The reregistration requirements for magnitude of the residue in processed
food/feed commodities are fulfilled for cottonseed and soybeans. The processing data
from these studies do not indicate the need to establish tolerances on processed
commodities, except for soybean hulls.
Based upon the 3.6x concentration factor for soybean hulls and highest average
field trial (HAFT), residues of 0.103 ppm, the maximum potential residues in hulls would
be 0.37 ppm. Therefore, the current 0.8 ppm tolerance for soybean hulls should be
lowered to 0.4 ppm. .:
Data from the soybean processing study also indicate that thiodicarb residues
27
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'S fHf:>IP.«ll ..... !i«^^^^^^^^^^^^^^^ .....
t> .......... t ....... • ........ -. ......... . ..... : ..... &< ..... v ............. -
concentrated 29x in aspirated grain fractions. The registrant should propose a tolerance
for aspirated grain fractions. Based upon the 29x concentration factor and HAFT residues
of 0.103 ppm, an appropriate tolerance would be 3 ppm.
OPPTS GLN 860.1480 rformerlv 171-4f); Magnitude of the Residue in Meat. Milk.
Poultry, and Eggs
No tolerances have been established for thiodicarb residues iii livestock
commodities. The requirement for a poultry feeding study has been waived. The Agency
believes mere is no reasonable expectation of finite residues, based upon the results of the
poultry metabolism study, which used a 255x feeding level [180.6(a)(3)].
, . >. . , ' , , • i
An adequate ruminant feeding study is available. Residues of thiodicarb and
methomyl were not detected in milk, meat and meat-by-products of dairy cattle dosed for
28 days at the maximum tolerated dose. The Agency concluded that there is no
reasonable expectation of finite thiodicarb residues in ruminant commodities [180.6(a)(3)].
Therefore, no tolerances will be required for livestock commodities.
OPPTS GLN 860.1850 (formerly 165-H: Confined Accumulation :in Rotational Crops
ii j i
An acceptable confined rotational crop study is available. The metabolism of
thiodicarb in rotated crops is similar to that in primary crops. Combined residues of
thiodicarb and methomyl were detected at >0.01 ppm in RACs of leafy vegetable, root,
and grain crops planted at 31- and 125-day rotational intervals. Total radioactive residues
were <0.01 ppm in all RACs at the 364-day rotational interval.
OPPTS GLN 860.1900 rformerlv 165-2): Field Accumulation in Rotational Crops
H, I „
Based upon the results of the confined rotational crop study, a plant-back interval
must be added to EP labels. The registrant can choose to conduct limited field rotational
crop trials at the desired plant-back interval following soil treatment at lx the maximum
registered rate (7.5 lb ai/A) at two test sites. If residues of concern are detected in rotated
crops from the limited trials, extensive rotational crop field trials will be required to
i niiiiiiiFTji' < Jinn, i.'ii iiiiiiiiiiiiiiiiiiiinii'«iii, iiiiiiiiiiiiini1: iitnii i: i inn iiiiini:' i, mK'a- IMF inn iiiiiiii," iiiiii»ni • n, ainui niiuMiRminir1^ 11
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b. Dietary Risk Assessment and Risk Characterization
The Agency has determined that thiodicarb has a metabolite, methomyl, which is
also a registered pesticide. Therefore, in addition to the thiodicarb risk assessment,
methomyl residues resulting from applications of both thiodicarb and methomyl will be
considered in an aggregate risk assessment and compared to appropriate toxicological
endpoints for methomyl. .
Chronic (Non-Cancer) Risk- Thiodicarb Alone /food source only')
A Dietary Risk Evaluation System (DRES) chronic exposure analysis was
performed using tolerance level residues and percent crop treated information to estimate
the Anticipated Residue Contribution (ARC) for the general population and 22 subgroups.
Using existing tolerances (and pending tolerances on peppers, tomatoes and peanuts) and
the higher tolerance level for cottonseed, the anticipated residue contribution for the U.S.
Population occupies 68% of the FQPA adjusted RfD. For females (13 years and older)
67% of the FQPA adjusted RfD is occupied. For children (1 to 6 years old) and infants,
104% and 43%, respectively ..of the FQPA adjusted RfD is occupied. Although for
children (1 to 6 years old), the FQPA adjusted RfD is slightly exceeded, if more refined
estimates of dietary exposure were made (e.g. using residues from field trials) significantly
lower chronic risk would be estimated. Therefore, the chronic risk from exposure to
thiodicarb from food sources is not of concern.
Chronic (Non-Cancer) Risk - Thiodicarb and Metfaomyl Combined (food source onlvY
Chronic exposures to methomyl residues from both thiodicarb and methomyl
applications were combined and compared to the methomyl reference dose. The
aggregated chronic exposure is shown in the table below (MRIDs 44328701,44343601,
44360702).
Table 8 - Chronic Aggregate Risk - Thiodicarb and Methomyl Combined
Population Subgroup
U. S. General ,
Children (1 to 6 years)
Infants
Dietary %RfDa
1-9 .
2.7
6.5
Dietary %RfD includes methomyl residues from application of thiodicarb and methomyl
Results of the chronic exposure analysis show that no single subpopulation
exceeded 7% of the RfD. For the subpopulations, infants (<1 year old) and children (ages
1- 6 years old), 6.5% and 2.7% of the RfD is occupied, respectively. For the general U.S.
population, only 1.9% of the RfD was occupied. In this analysis, percent crop treated
information and anticipated residue data were used for all 70 commodities. ,
. ' ' '. 29 •. . ' ' ' '
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'ai'llilllV;;!!!,!:!1 ' i'1 !IIK^
•!• '"I "I"'1' •, 'i.!11!11 fli „ i • ,i fl * SKK '"'!'" '!'« f* ,„' •
" —"'" '•'?:: ~".:"!™ Cancer Risk- Thiodicairb Alone
A linear methodology (Qj *) was applied for the estimation of human cancer risk
, ,,ani»ffl§ c;a|culate,d tg feg | J|i,,|Qf, The assessment'was conducted fcr the general U.S.
Population only. The cancer exposure is estimated by multiplying ithe Q*"(1.88 x 10'2) by
the chronic dietary exposure (0.000020 mg/kg/day). This chronic dietary exposure
utilized both anticipated residue and percent crop treated information. The upper bound
cancer risk was calculated to be 3.76 x Ip;7. This upper bound risk is below the range the
^gg££y- genef£jjy considers neglible for excess liietime cancer risk and is not cause for
concern.
I ' " I H . '" H || |
Acute Dietary Risk - Thiodicarb Alone (food source onlv")
To estimate acute dietary exposure, the registrant conducted Monte Carlo
simulations for the overall U.S. population, women 13 years and older, children 1 to 6
years of age, and infants. These analyses included residue levels determined from field
trial studies, consumption data from the 1994 through 1996 USDA Continuing Survey of
Food Intake by Individuals (CSFII), and information on the percent crop treated. The
USDA provided statistical weights that permitted the data from the various years of the
CSFII survey to be combined (MRIDs 44328701,44343601,44360702).
Field trial residue levels were used for all crops. In compliance with the EPA's
guidance document, residue distributions from field studies conducted at maximum label
conditions (e.g. maximum number of applications, maximum application rate, and
minimum preharvest intervals) were used for foods considered to be single-serving
commodities (e.g. cabbage, broccoli, lettuce); while mean field trial residues were used for
blended/processed commodities (e.g. cottonseed meal, soybean oil).
i in i ii 11 ii
iiiiiiii
Processing factors were calculated for cottonseed meal, cottonseed oil, and
soybean oil. These factors were used in conjunction with the mean field trial residues to
estimate residue levels in the processed commodities.
iiiiiii (in n i •
Residue values were adjustedi for the: percent of the crop estimated to be treated
with thiodicarb. These percentages were provided by the Agency's Biological and
Economic Analysis Division (BEAD). The maximum percentage reported for a particular
crop was used in the acute exposure analyses. Percent crop treated information was not
provided for swiss chard, parsley, watercress, and endive. The percent crop treated for
spinach was assumed for these crops.
Th,e Monte Carlo analysis incorporates a purported 93% decline in residues for
some commodities as the result of cooking. These results were reported for methomyl.
The cooking factor 0.07x (i.e., 1- 0.93 = 0.07) was applied to a variety of leafy vegetables
(including broccoli, cabbage, spinach, and cauliflower). A confirmatory cooking study to
30
I If IF I IIIIIIII IIJ |l I 111 III
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, validate the 0.07x (93% reduction) cooking factor for thiodicarb is required to be
submitted by June 30,1999. The registrant must consult with the Agency concerning the
conduct of these studies including the appropriate cooking methods and cooking time as
well as the specific crops on which studies should be conducted. In addition to the
cooking factor, an average decline of 75% in residues on celery following trimming of
celery tops was included in the Monte Carlo analysis. ;
, • Acute exposure estimates to thiodicarb were compared to the, developmental
L.OEL of 10 mg/kg/day for the population subgroup women 13 years and older. For the
overall U.S. population, children 1 to 6 years of age, and infants, acute exposure estimates
were compared to the maternal LOEL of 10 mg/kg/day.
The Margin of Exposure (MOE) is a measure of how close the high end exposure
comes to the NOEL ,(the highest dose at which no effects were observed in the laboratory
test),,and is calculated as the ratio of the NOEL to the exposure (NOEL/Exposure —.
MOE). A MOE of 1000 is required for acute dietary risk assessment for Females 13 years
and older, as well as for the General Population including Infants and Children. This
MOE includes the conventional MOE of 100, 3x for FQPA, and another 3x for the use of
a LOEL instead of a NOEL. For this risk assessment the FQPA Safely Factor (3x) is
required because of datagaps (acute and subchronic neufotoxicity studies). The MOEs for
acute dietary exposure were calculated using the estimates at the 99.9 percentile of
exposure for groups of concern. The acute MOEs for the application of thiodicarb are
"presented in the table below.
Table 9 - Acute Exposure. MOEs from the Application of Thiodicarb
Group of Concern
U.S. Population
Woman 13 years and older
Children 1 to 6 years
Infants
Exposure
0.013792
0.013500
0.022758
0.010575
LOEL
10 mg/kg/day
10 mg/kg/day
10 mg/kg/day
10 mg/kg/day
MOE
2450
2100
2900
1680
Acceptable MOE
1000
1000
1000
1000
The results of the acute exposure analyses indicate that there are adequate margins
of exposure for the general U.S. population, women 13 years and older, children 1 to 6
years of age, and infants. ,
Acute Risk - Thiodicarb and Methomvl Combined (food source onlv^
The registrant provided and the Agency has found acceptable, an acute dietary
Monte Carlo distributional risk assessment which utilized combined residues of methomyl
from the application of thiodicarb and residues of methomyl from the application of
methomyl. For this analysis, percent crop treated information and field trial residue data
were .used for all commodoties. The methomyl acute dietary NOEL of 6 mg/kg/day was
used to calculate the MOEs. The estimated MOEs are shown in the table below. An
31
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MOE of at least 300 is considered acceptable (MRIDs 44328701,44343601,44360702).
Table 10: EPA-calculated Margins of Exposure (MOEs) for Various U.S. Subpopulations
Based on Acute Effects and 24-hour intervals (NOEL = 6 mg/kg BW/day).
Population Group .
U.S. Population
95th percentile
99th percentile
99.9th percentile
Infants
95th percentile
99th percentile
99.9th percentile
Children 1-6 years
95th percentile
99th percentile
99.9th percentile
Food
24 hour interval
mg/kg BW/day
0.000349
0.001099
0.006577
0.000215
0.000874
0.007940
0.000482
0.002108
0.014396
MOE
17192
5460
912
27907
6865
756
12448
2846
417
Although refined using percent crop treated data, these estimates are still likely to
be a conservative estimate of the Margin of Exposure. For example., they assume that
residues, when present, are: present ^aresvit of application at the maximum permitted
level and observance of the minimum PHI. No reduction as a result of transport time from
farm gate to consumer is assumed to occur. The Agency concludes 'that sufficient margins
of exposure exist at the 99.9th percentile value.
c. Aggregate Exposure
In examining aggregate exposure, FQPA directs The Agency 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 and 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. There are no residential uses of thiodicarb, therefore aggragate
exposure includes only those exposures from food and drinking water.
Thiodicarb degrades rapidly in water to methomyl. Methomyl is the pesticide
momtorejin Therefore, the relevant water
exposure is to methomyl and the drinking water risk assessment was conducted for
methomyl only. The aggregate dietary risk assessment was, therefore, based on exposure
1 ^ * ns I III I I I I II II III I II
32
II II I II I II I Illlllllllllllli I II I II I III I II I I I +Jf*
1 in ii in null i in In in n
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from methomyl from the application of thiodicarb, methomyl from the application of
memomyl, and methomyl in water. ;
d. Drinking Water Assessment
OPP has calculated drinking water levels of concern (DWLOCs) for methomyl in
surface and ground water for the U.S. population and children 1 to 6 years old (Standard
Operating Procedures for Drinking Water Exposure and Risk Assessments, 11/26/97 and
Interim Guidance for Conducting Drinking Water Exposure Estimates, 12/2/97). For
acute exposures, they are 470 and 56 ppb, for the U.S. population arid children (1-6 yrs
old), respectively. For chronic (non-cancer) exposures they are 275 and 78 ppb for the
U.S. population and children (1-6 years old), respectively.
To calculate the DWLOC for acute exposure relative to the acute toxicity
endpoint, the acute dietary food exposure (from the combined thiodicarb and methomyl
Monte Carlo analysis) was subtracted from the ratio of the acute NOEL (used for acute
dietary assessments) to the "acceptable" MOE for aggregate exposure to obtain the
acceptable acute exposure to methomyl in drinking water. To calculate the DWLOC for
chronic (non-cancer) exposure relative to a chronic toxicity endpoint, the chronic dietary
food exposure (from ORES) was subtracted from the RfD to obtain the acceptable
chronic (non-cancer) exposure to methomyl in drinking water. DWLOCs were then
calculated using default body weights and drinking water consumption figures.
Estimated concentrations of methomyl in surface water are from PRZM/EXAMS
modeling. The estimated maximum (acute exposure) concentration is 30 ppb and the ,
estimated average (chronic exposure) concentration is 26 ppb. The estimated maximum
concentration of methomyl in ground water is 20 ppb based on the Agency's Pesticides in
Ground Water Database. Average concentrations in ground water are not expected to be
higher than the maximum concentrations. These estimated concentrations of methomyl in
surface and ground water are less than the Agency's levels of concern for methomyl in
drinlcing water as a contribution to acute and chronic aggregate exposure. Therefore,
taking into account the present uses, the Agency concludes with reasonable certainty that
residues of methomyl in drinking water when considered along with other sources of
exposure for which the Agency has reliable data would not result in levels of aggregate
human health risk that exceed levels of concern.
The estimates of methomyl hi surface and ground waters are derived from models
that use conservative assumptions (health-protective) regarding the pesticide transport
from the point of application to surface and ground water. Because the Agency considers
the aggregate risk resulting from multiple exposure pathways associated with a pesticide's
uses, levels of concern in drinking water may vary as those uses change. If new uses are
added in the future, the Agency will reassess the potential impacts of thiodicarb and
methomyl from the application of thiodicarb on drinking water as a part of the aggregate
33
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risk assessment process.
Endocrine Disruption
t " "
The Agency 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 isi currently working with interested stakeholders, including other
government agencies, pubic interest groups, industry and research scientists in developing
a screeningand-testingprogramandapriority setting scheme to implement this program.
Congress IhaValiowed "3 'years'fiainthe passage'of FQPA (August 3,1999) to implement
this program. At that time, the Agency may require further testing of this active ingredient
and end use products for endocrine disrupter effects.
e.
Cumulative Risk
Section 408(b)(2)(D)(v) of the Food Quality Protection Act requires that, when
considering whether to establish, modify, or revoke a tolerance, the; Agency consider
"available information" concerning the cumulative effects of a particular pesticide's
residues and "other substances that have a common mechanism of toxicity." The Agency
believes that "available information" inthisi context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and methodologies for
understanding common mechanisms of toxicity and conducting cumulative risk
assessments. For most pesticides, although the Agency has some information in its files
that may turn out to be helpful in eventually determining whether a pesticide shares a
common mechanism of tpxicity with any other 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 mis issue further through the examination of particular classes of pesticides. The
Agency hopes that the results of this pilot process will increase the Agency's scientific
understanding of this question such that the Agency will be able to develop and apply
scientific principles for better determining which chemicals have a common mechanism of
toxicity and evaluating the cumulative effects of such chemicals. The Agency anticipates,
however, that even as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on chemical specific
data, much of which may not be presently available.
Although at present the Agency does not know how to apply the information in its
files concerning common mechanism issues to most risk assessment, there are pesticides
for which the common mechanism issuescan .be.addressed. These pesticides include
pesticides that are lexicologically dissimilar 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
34
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which case common mechanism of activity will be assumed).
. - '_ • , i '•'&•_ , '
The Agency does not have, at this time, available data to determine whether
thiodicarb 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 reassessment,
therefore, the Agency has not assumed that thiodicarb has a common mechanism of
toxicity with other substances.
4. Occupational and Residential
~ - • . - '/ ' •
a.' Occupational and Residential Exposure
. 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.
Occupational-use products and homeowner-use products
At this time, products containing thiodicarb are intended for occupational use only
and not for homeowner use. Therefore, no residential risk assessment is required.
Epidemiological Information
The following data bases have been consulted for poisoning incident data for
thiodicafb: . ." v
(1) OPP Incident Data System (IDS): There were two reported cases of incidents
involving thiodicarb. Both individuals were treated by a physician.
(2) California Department of Food and Agriculture (replaced by the Department of
Pesticide Regulation in 1991): No cases of thiodicarb illnesses or injuries have
been reported in California during the reporting period of 1982-1993. However, .
almost no usage by commercial applicators has been reported for this chemical
during this time period. ,
(3) National Pesticide Telecommunications Network (NPTN): Using the list of
the top 200 chemicals for which NPTN received calls from 1984-1991 inclusively,
thiodicarb was not reported to be involved in any human incidents.
In summary, almost no information is available from any of the data bases
consulted by the Agency on incidents related to the use of thiodicarb.
35
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assumed to be the upper range of the number of applications that may be done by a
commercial applicator. .
In general, typical application rates are used in cancer assessments, however, typical rates
were not available and the maximumjrate was used.
A 2 percent dermal absorption and 100 percent inhalation absorption were used.
37
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b. Occupational Risk (Non-Cancer) Estimates
11I lull 1
Estimates of exposure and risk indicate that, for some scenarios, measures to
IMuce handlers exposures should be considered. Table 12 shows the levels of mitigation
needed to attain MOEs greater than 300, while Table 14 describes the data quality and
confidence level for each scenario. Options to reduce handlers' exposures and risk range
from personal protective equipment (dust mist respirator) to engineering controls (water
soluble packets).
ji|;'ft||i|i^liM':i^i:';ii^?,'^^i]isSS siiaailPg inhalation risk from the previous table indicate that the
MOEs are acceptable (300 or greater) at baseline (no respirator) for the scenarios
identified below. :
• (2b) mixing/loading liquidsifor groundboom application;
(3a) mixing/loading dry flowables for aerial and chemigation application;
• (3b) mixing/loading dry flowables for groundboom application;
• (6) applyhig sprays with a groundboom sprayer;
* (7) mixing/loading applying liquid with a backpack sprayer;
• (8) mixmg/loading applying liquid with a low pressure handwand;
• (9) mixing/ioading applying liquid with a high pressure handwand; and,
•;,.,, h 1^ ,,",,,, ^r'^ !;,|l|)) jni^f^o^ding, agP&H1i .g13111^318 w^1 a kelly-grinder spreader; and,
^fl^-^'''^^^^^!''^™^'^?) flagging Squid aerial applications.
•^m'„!:•&''ImMi'^i^iml i:llF '
.USE" £ St. «if;'*"*^?^;*i!2^'!T^»c^cula.tions estimating inhalation risk indicate that the MOEs are acceptable
!!t!;u:f 2 : "•: • sr^^i^'xC^? or gEa!e!2 ?$ik M?. (a, .^H8^™?!, •r?sl)U'ator ^. s"1g^'laver ^C^9^P§) l9r ^®
following scenario: . ,,,-.,,. ,,
S (2a) mixuig^oading liquids for aerial and chemigation applications;
The calculations estimating inhalation riskVindicate that the MOEs are acceptable
(300 or greater) with the noted engineering controls and single layer of clothing for the
following scenarios:
(la) mixmg/loading wettable powder for aerial and chemigation application
(water soluble packets);
• (Ib) mixing/loading wettable powder for groundboom application (water
soluble packets); .
(4) applyhig liquid sprays witha fixed-wing aircraft (closed^cockpit); and,
• (5) applying liquid Sprays with a helicopter (closed cockpit).
(f , J •"
In the regulatory section this information has been integrated with other
considerations, including the toxicity concerns pertaining to methomyl, a degradate of
thiodicarb, in determining the required PPE.
J-v , h „ . u ' ,. ',
46 '.
I
-------
When estimated MOEs for closed-cockpit exposure scenarios are an order of
magnitude larger than the uncertainly factor (i.e., the acceptable MOE), then this scenario
would also be acceptable using an open-cockpit plane. For thiodicarb, an occupational
MOE of 300 or higher is required to be above the Agency's level of concern. The open
cockpit MOEs range from 3,500 to 133,333. Therefore, an enclosed cockpit is not
required for scenarios 4 and 5 above.
In summary, all handler scenarios have acceptable MOEs (300 or greater) at
baseline or with the npted PPE or engineering controls.
c. Occupational Cancer Estimates
The estimations of cancer risks are within the 10"4 to 10"8 risk range for all
scenarios at baseline except for the following scenarios:
Scenarios 4 (fixed-wing aerial spray application) and 5 (helicopter spray application)
include closed cockpits for aerial applications because there are no data available to assess
an open cockpit. However, since the estimated risks for closed-cockpit exposure
scenarios (airplane 1 x 10"7 and helicopter 1 x 10"8) are at least an order of magnitude
larger than the acceptable risk (1 x 10"4), use of an open-cockpit plane is acceptable.
Scenarios 7 (backpack sprayer) and 9 (high pressure handwand) which include chemical
resistant gloves because no data are available to assess a no glove scenario.
:, . d. Post-Application
Exposure and Assumptions.
There are no short1 or intermediate-term dermal endpoints of concern for
thiodicarb, and a post-application inhalation risk assessment is not warranted. However,
thiodicarb rapidly degrades to methomyl. Therefore, the toxicity concerns pertaining to
methomyl, a degradate of thiodicarb, are considered in the post-application risk
assessment. For methomyl, the short- and intermediate-term NOEL for dermal toxicity is
90mg/kg/day. -.
A dislodgeable foliar residue (DFR) study was conducted for thiodicarb on lettuce,
(MRID 43198102) to measure the amount of residue remaining on lettuce each day after
treatment. In this study, residues of both thiodicarb and its breakdown product,
methomyl, were measured. However, as explained above, only methomyl residues are
included in the risk assessment. Four applications of thiodicarb were made to head lettuce
at a rate of 0.75 pounds active ingredient (ai) per acre at 7-day intervals for a total
application of 3.0 pounds a.i. per acre. Four trials were conducted: two in the Imperial
47
-------
|| d' I f T I
Valley, California, and two in the San Joaquin Valley, California. Residue samples were
taken before and after each application and on days 1,5,7,10,14 and 18 following the
last application. A review of the QA/QC results for this study indicate that the laboratory,
field, and storage recoveries were all within an acceptable range of 70 to 120 percent. At
the Imperial Valley site, the spring application (^arch/April of 1993) residue data were
riot used for this assessment because of a rain event that affected residue results. The
residues from the other three test runs were averaged. This study has several limitations:
were not collected on the day of application after ithe sprays had dried
'"for the study (>18 DAT)
£g ^Synoj^e, apjiropjiate since measurable residues were still being found on the
last day samples were measured; and (3) concurrent monitoring of dermal samples was not
conducte.cL
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""" •1^*.1:^ Since. no c^cj^e.p|.4e_r|gaj...samples were monitored during the lettuce study,
transfer coefficients (tc) are estimated to represent potential dermal transfer of residues.
The Agency has estimated 1,000 cm2/hr to represent the transfer coefficient for crops with
relatively low potential for dermal transfer during routine post-application activities, and
e..^55^r..£9?Msi§9* IS SPPS wim medium to high potential
routine post-application activities. The Agency believes these
SSSSig SB3iIsSa§i JJlS following crops are considered
vely low potential for post-application dermal transfer: broccoli, cabbage, .
cole crops, kttuce and other leafy vegetables, cotton, and soybeans. The following
are considered to have high potential for post-application dermal transfer: sweet
citrus, ornamental and/or shade, trees^ and ornamental herbaceous plants. The
^^S?^^..^.^?*®™^6^ that the anticipated frequency, duration, and degree of exposure
following applications to rights-of-way, hedgerows, fencerows, and drainage areas are
likely to be low and do not warrant an exposure and risk assessment.
i ,
"' I I;, 11 The Agency has no data^with which to assess the potential post-application
exposure and risk re-su||Jg gom applications of the granular formulation of thiodicarb to
soil in nurseries and greenhouses. However, The Agency estimates that the exposure to
persons transplantingsuchplants would'be ^roughly equivalent to exposures to workers in
crops where the potential level of dermal transfer is relatively low, since the majority of
exposure will be to the hands. Therefore, the estimates of potential post-application
exposures to workers in crops with potentially low dermal transfer will be used as a
reasonable surrogate for estimates of the potential post-application exposures to workers
following soil-directed granular applications.
^s the lettuce DFR study overestimates potential methomyl
residues in. lettpse.and other leafy vegetables since the seasonal application rate used in the
study with_head lettuce was ^cethejabeledrate. The label states that application to
lettuce and other leafy vegetables shou]5 not exceed 1.5 pounds active ingredient per acre
per season, but tiie study was conducted at 3 pounds active ingredient per acre per season.
I n IIIHII III UN Illili
48
-------
The Agency believes the DFR study underestimates the potential methomyl
residues following thiodicarb applications to most other crops for several reasons: (1)
several crops have an application rate (single application) greater than the 0.75 pounds ai
per acre rate used in the study; (2) labels recommend applications to many crops more
frequently than once per week as was used in the study; and (3) several crops have
seasonal maximum rates of greater than the 3.0 pounds ai per acre applied in the study.
For example, labels allow application of 0.75 pounds aiper acre to sweet corn at one- to
two-day intervals up to a seasonal maximum of 7.5 pounds active ingredient per acre.
For cole crops, the label allows application of 1.0 pounds ai per acre as often as needed up
to a seasonal rate 'of 6.0 pounds ai per acre. Methomyl residues on these crops are likely
to be significantly higher than those reported in the DFR study on lettuce. .
In the absence of data specific to these other crops, the Agency has roughly
estimated potential exposure and risk to workers using the data from the lettuce study. If,
based on the higher application rate and greater frequency of exposure, the DFR levels for
these crops on day 1 were double those reported for lettuce, (see following table under
"Risk estimates") the day 1 MOEs would be 3,170 for crops with potentially low dermal
transfer (assuming a transfer coefficient of 1,000 cm2/hr), and 317 for crops with
potentially high dermal transfer (assuming a transfer coefficient of 10,000 cnrVhr).
• . - .. • • \
While the Agency believes that doubling the reported DFRs from the lettuce study
represents a reasonable.high.-end estimate for potential DFR levels for these other crops,
some uncertainites exist about actual residue levels that would result if higher rates were
used at shorter intervals, as is permitted by labels of these other crops. Additionally, the
assumption of a transfer coefficients of 1,000 cm2/hr to 10,000 cm2/hr is believed to
represent a realistic range of potential transfer coefficients for the crops considered, based
on data from these crops for other chemicals with which the Agency is familiar. However,
without actual exposure monitoring data a degree of uncertainty about actual levels of
exposure exists.
Given these uncertainties, the Agency notes that, assuming the higher transfer
coefficient, the lowest MOE is still three times higher than that which would be considered
acceptable. Thus, if the DFR values for these crops were as much as 6 times the day 1
values reported in the lettuce study, MOEs for even crops with potentially high dermal
transfer would still exceed 100.
The table below compares the maximum application rates, application frequency,
and maximum seasonal application rates for each use pattern to the use pattern used in the
lettuce study. ' , ,
49
-------
II I I II 1 1
Table IS - Maximum Application Rate, Application Frequency, and Seasonal Rates for Thiodicarb.
lilililliWlilllinllllllllllillili
CROP
Maximum Application
Rate (Ib ai/acre)
Frequency of
Applications
Maximum Seasonal
Rate (Ib ai/acre)
"I'll""!!! IN- ill
Lettuce Study (MRID 43198102)
0.75
7 days
3.0
Lettuce & Other Leafy Vegetables
Broccoli & Other Cole Crops
0.75
1.0
as needed
as needed
1.5
6.0
Cotton
Soybeans
0.9
0.75
3 to 5 days
none specified
5.4
Citrus
Ornamentals
0.75
0.75
< as needed
as needed
4.5
4.5
Sweet Corn
0.75
1 to 2 days
7.5
Rights-of-way, Hedgerows, Fencerows
0.76
Drainage Systems
0.76
none specified
none specified
4.56
6.0
It should be noted that &e registrant is a member of the task force that is.
developing more refUe3 g^ on agnci&torai re.entry exposure. As these data become
available, they | will be used to refine re-entry exposure estimates.
e. _Post;Application Risks
losing the DFR data from the lettuce study and estimated transfer coefficients
discussed above, exposure, dose, MOEs, and cancer risks for post-ajpplication activities
were estimated. The results are presented in the tables below
^ n _ m _ n K. II'Byr I
,, „,,,,, , ,, H,,, ,„,, ,.• i;;:";;: s' .^n." >1 :^l: "I,;:'~K",
,!"""!,'II!""1!I"'""",,Til" „' """! ",,1!"1"""'"!,„, "! ',,TT,,T,! „!,„'"! ", "!"!„'!"',,™ '„""",'!,",' !""m ,",', !,,'"r,!,,,!
""ii;™11' !HJE ;:ii! fi"'1 si'*:!11'!| iPf i;,,!* ™!™^^ 'iii;,!1 ''.'i'1!!;1;'1';;"'1'11'!!!' i1 i !!|!l!n|j; i™!'!!^^ l|"ij|i;l:!i 'i";,;1 'tliiiJJJJ'Fi'i^ 'i1!;1'111'!:Jilijiiii^^ i*r ''^jiiiwsiij LjicLia
lJ!«:.!"4;>il(fi":Hi!^HWf sSM^rlJ'3ffl'^^4WiiiKBliifflW iJr^lW'*1W^'|l^':iS!!i!;'i*8BSlv*Willffl|fii<;. ' > *'' - •" ' s- '*»' ••'- «'i ' i • * '^ "!:ii':i»! I
sS I
" '' |M :'||L |!!|'"" I|MI '1!' •' ' ' ;l!" ' ' ' • :"'' ^"' •:"''nl :v""l!'' '" !'!l ''''" 1!l " l!lll!! ll|l::''"'" ' l|l!!l1""" "l|ll|l! Tl1''""f'!!l "!'' ' : !|l|i!! l! ':i!!l !!l""' :! fl'' ' ll! l!:ill!l': ''; I;H! '
rjiiiife : 'imaim .t sfiM^^^^^^^^^^^^^^^^ iiiM^^^^^^ .
-------
Table 16 - Workei
of0.751bfor4ap
- Days After
Treatment
1
• Reentry Exposure to Methomyl Residues Following Thiodicarb Application (Application rate
plications at 7 day intervals for a total of 3.0 Ib per acre per season)
Best Fit DFR
, Oug/cm2)*
0.1242
Tc (cm2/hr)b
Lf 1,000
M/H* 10,000
Exposure
(mg/day)c
0.994
9.936
Dose
(mg/kg/day)1
0.0142
0.142
MOEe
6338
634
The average foliar dislodgeable residues from the lettuce study (MRID 43198102). These are also used as a
surrogate for other crops. DFR (,ug/cm2) was derived by converting the measured DFR data into lognormal
distribution then running a linear regression equation to estimate the dissipation over time.
b Transfer coefficients estimated by the Agency. ,
0 Potential average daily exposure (ADE) (mg/day) - [(Best Fit DFR x Transfer Coefficient (1,000 or 10,000
cnrVhr)) / 1,000 Mg/mgj x 8 hrs/day. Because the toxiciry data are from a dermal study, dermal absorption is not
factored into the equation.
d Dose (mg/kg/day) = Exposure (mg/day) / 70 kg. •
e MOE = NOEL (90 mg/kg/day) / Dose (mg/kg/day). .
f L = crops with potentially low dermal transfer to post-application entry workers.
s M/H = crops with potentially medium to high dermal transfer to post-application entry workers.
The postapplication thiodicarb cancer assessment in Table 17 is a screening level (i.e., tier
1) assessment that has not been refined because the calculated risk was not a concern. For
example, the transfer coefficient, the thiodicarb DFR value of 1.26 ^g/cm2 (without considering
dissipation over tune), and the number of days harvesting (30 days/year) were selected as
conservative assumptions to provide a reasonable certainty that the risks would not be
underestimated. Using these conservative exposure inputs, the calculated risk provides adequate
protection for the worker and no refinements are necessary at this time.
Table 17. Worker Reentry Cancer Risk Assessment.
Days After
Treatment
1
Average DFR
C"g/cm2)a
1.26
Tc(cm2/hr)b
10,000
Absorbed
Dermal Dose
(mg/kg/day)P
0.029
LADD
(mg/kg/day)1
' 0.0012
Risk6
2.3E-5
The average foliar dislodgeable residues from the lettuce study (MRED 43198102). These are also used as
a surrogate for other crops. The DFR (^g/cmz) value is the arithmetic mean thiodicarb (excluding
methomyl) residue for five sites.
b-. Transfer coefficient (Tc) estimated by the Agency.
c Absorbed Dermal Dose (mg/kg/day) = (DFR * Tc * 8 hrs/day * 0.001 mg/^g conversion * 0.02 dermal
absorption) / 70 kg body weight.
d LADD (mg/kg/day) = Absorbed Dermal Dose (mg/kg/day) * (30 days worked/365 days per year) * (35
years worked/ 70 year lifetime). Assuming 30 days worked per year and a DFR with no dissipation.
e Risk = LADD (mg/kg/day)/Q,* of I.88E-2 (mg/kg/day)-1
The calculations estimating worker reentry exposure from the previous tables
indicate that the MOEs are 100 or greater for the following:
51
-------
for crops with potentially low dermal transfer, on the day following application (24
hours); and
for crops with potentially medium to high dermal transfer, on the day following
application (24 hours).
SS§^2??^S,?S^^.2CMi9gses_siment, the Agency believes an REI of 24 hours is
sufficiently protective of workers following applications of thiodicarb. In the regulatory
section this information has been integrated with other considerations including incident
data to determine the required REIs.
I I1 Jlliil;;!!;!«!'IKWJll ll-lllll'llliiiilll'lrll'i'llllll'iinillllilliiiilil!, II H'i11'!'i'l'ii'"in !!i|»!l 'niflPK! n.l mi w w 11 .iiaiiii::>ra you*)!** ill nitumsrw>n 'Biipst; • ifait '.iwrwii.iii*' •£•*'" TH '""i* XT,.smi >•
IK ii::1!1 W'9,1 If' • ill'"!*! ' M 'ri. IIIIIIHI!1 illf'. i :.i!:i:>:li(.r:X^ fill .Si T)!"!!! Illllll: i 'titnM^^^^^^ IWiliSM^ .':.'.::' IK 1 "SSi' i'<" i,"' ili! KM!!-! 'f.ii.')""1)' "1 £>::!'!l: :,l|i"' I':!: Ht/1,'*»',': 4>lRl:i!'»!' liiilltiW.'.: I'K. '!!l!>' '"I""!!!'" .••>. > •;!.''' • ' ' »•' i t
!„:, ,; t,n. ,,,,,, , , '^^^MM^m^!^MMj^S^]Sm
ire not re
n^
. Studies •; •- _ i •
gllll Rased ,on,|he riskassessment of the current uses of thiodic, arb, additional post -
application exposure studies are not required at this time.
—:•::;":,::";::C. Environmental Assessment
The Agency has adequate data to assess the hazard of thiodicarb to nontarget
terrestrial organisms. However, an estuarine/marine fish early life-s'tage test, an
estuarine/marine invertebrate life-cycle study and a field dissipation study on cotton and
corn are required as confirmatory information.
- «
The Agency's major concern with the use of thiodicarb is its relatively rapid
'm degradation into the more toxic, mobile and persistent chemical, melhomyl. Therefore,
the environmental fate and effects exposure assessments for thiodicarb must also take into
account the'fate andexposure of methomyl.
: 1. Toxiciiy to_ Terrestrial. Animals
a. Birds, Acute and Subacute
An acute oral toxiciry study using the technical grade of the active ingredient
(TGAI) is required to establish the toxiciry of thiodicarb to birds. The preferred test
species is either mallard duck (a waterfowl) or bobwhite quail (an upland gamebird).
52
iiiiiiiiiiiiiiiiliiiiliiiiiiiiiiiiiiiB iiiiiii 1 iiiiii 11 iiiiiiiiiiiiiiiiiiiiiiiiiii in I iiiiii 11111 iiiiii 11 in 111 ill | nil 111 nil iiiiii iiiiiii|ii MM i ill n 11 (in
-------
Results of this test are tabulated below.
Table 18 - Avian Acute Oral Toxicity
Species
Northern bobwhite quail
(Colinus virginianus)
% ai
99
LD50 (mg/kg)
2023
Toxicity Category
Practically nontoxic
MRID No.
Author/Year
00044269;
Fink, 1978
Since the LD50 is greater than 2000 mg/kg, thiodicarb is practically nontoxic to
avion species on an'acute oral basis. The guideline (7l-l) is fulfilled (MRID 00044269).
Two subacute dietary studies using the TGAI are required to establish the toxicity
of thiodicarb to birds. The preferred test species are mallard duck and bobwhite quail.
Results of these tests are tabulated below.
Table 19 - Avian Subacute Dietary Toxicity
Species
Northern bobwhite quail
(Colinus virginianus)
Mallard duck
(Anas platyrhynchos)
%ai
99
99
5-Day LC50 (ppm)1
>5620
>5620
Toxicity Category
Practically nontoxic
Practically nontoxic
MRID No.,
Author/Year
00044271;
Fink, 1978
00044270;
Fink, 1978*
1 .Test organisms observed an additional three days while on untreated feed.
Since the LC50 falls in the range of >5620 ppm, thiodicarb is practically nontoxic
to avian species on a subacute dietary basis. The guideline (71-2) is fulfilled (MRID
, 00044270,00044271). . '- .
The available acute toxicity data on the TGAI for methomyl indicate that it is
highly toxic to birds (LD50 = 15.4 mg/kg) on an acute oral basis and slightly toxic to birds
(LC50= 1100 ppm) on a subacute dietary basis.
b. Birds, Chronic ••,'.••
^ • '''.'•"
Avian reproduction studies using the TGAI are required for thiodicarb because
birds may be subject to repeated or continuous exposure to the pesticide, especially
preceding or during the breeding season. The preferred test species are mallard duck and
bobwhite quail. Results of these tests are tabulated below.
53'
-------
d.
Insects
A honey bee acute contact study using the TGAI is required for thiodicarb because
its use may result in honey bee exposure. Results of this test are tabulated below.
Table 21 - Nontarget Insect Acute Contact Toxicity
Species ,
Honey bee
(Apis mellifera)
% ai
99.95
LD50 fcg/bee) -
>25
Toxicity Category
Practically nontoxic
MRID No.Author/Year
42528501; Petto, 1992
The results indicate that thiodicarb is practically nontoxic to bees on an acute
contact basis. The guideline (141-1) is fulfilled (MRID 42528501). ,
For methomyl., an analysis of the results of the honey bee acute contact study
indicates that methomyl is categorized as highly toxic to bees (LD50 = 0.3 ug/bee).
2.
Toxicity to Aquatic Animals
Freshwater Fish, Acute
a.
Two freshwater fish toxicity studies using the TGAI are required to establish the
toxiciry of thiodicarb to fish. The preferred test species are rainbow trout (a coldwater
fish) and bluegill sunfish (a warmwater fish). Results of these tests are tabulated below.
Table 22 - Freshwater Fish Acute Toxicity
Species/(Flow-through or
Static)
Rainbow trout
(Oncorhynchus my kiss)
flow-through
Bluegill sunfish
(Lepomis macrochirus) flow-
through
% ai
94.9
99.9
96-hour LC50 (ppm)
(measured/nominal)
3.45 (measured)
1.47 (measured)
Toxiciry Category
Moderately toxic
Moderately toxic
MRID No.
Author/Year
41605502;
Bowman, 1990
41605501
Since the LC50 falls in the range of >1-10 ppm, thiodicarb is moderately toxic to
freshwater fish on an acute basis. The guideline (72-1) is fulfilled (MRID 41605501,
41605502). '.•-•"'•. '
Methomyl has been classified as moderately to highly toxic to freshwater fish (LQp
= 0.5 ppm to 6.8 ppm) on an acute basis.
55
-------
I ii Mi N11» j I 11 PI1 i1 in III
III1(| I, IIIlinlI l(hii I 11Hill |Hlii|
b. Freshwater Fish, Chronic
"•vi1"1;"' i",
l!''"
A freshwater fish early life-stage test using the TGAI is required for thiodicarb
™I»a fegpayse i^e end-use product may be expected to be transported to water from the
intended use site, and the pesticide is intended for use such that its presence in water is
:mtMf„likely to be continuous or recurrent. The preferred test species is rainbow trout.
18^^^^^^^^^^^^^^^^^^^^^^ ,«^^^^^^ !fc i ' i! • j< - ' "
fl(«^^^^ HK^^^^^^ i!H^^^^ !!li! ::!!! UHBfHfelKftl&Hil
ata from a valid freshwater fish early life-stage test with thiodicarb determined
;i Hajjsiili R&^f^iS&^SIffi^SS^i^S^^PJ^! |be= MATC for fathead minnows exposed to
^ between 25 and 53 ppb active ingredient. The geometric mean
determined to be.36 ppb active mgredtent (MRID 44484101).
iiiiii i
A freshwater fish life-cycle test using the TGAI is required for thiodicarb since the
eld-use product may be transported to water from the intended use site, and the following
£|ii||fions |are met: (1) the EEC is equal to br^ greater"iiiian one-tentti'pf iihe NOEL in the
fish early life-stage or invertebrate life-cycle test, or, (2) studies of other organisms
indicate the reproductive physiology offish may be affected. The preferred test species is
fathead minnow. Therefore, the freshwater fish life-cycle test using the TGAI is required
for thiodicarb.
in a fathead minnow freshwater fish early life-stage study wi th methomyl the
NOEC was 57 ppb based on larvae survival and the MATCwas greater than 57 ppb but
less than 117 ppb. •
c. Freshwater Invertebrates, Acute
iiNlliliNilifffJ1 IP! II, Illl'i "Ml i! i ilUIPFIIIIIIIIIIIiii! k MI'll'l iiJI,H!! lli< jiUIIH i.;i I ilininllliiiilWi 'ilKlluilnllllllll Illill1" in,, I > '»!( v " n ' v n I
A freshwater aquatic invertebrate toxicity test using the TGAI is required to
establish the toxicity of thiodicarb to aquatic invertebrates. The preferred test species is
Daphnia magna. Results of this test are tabulated below.
Table 23 - Freshwater Invertebrate Acute Toxicity
Species/(Static or Flow-
through)
Waterflea
(Daphnia magna)
flow-through
Waterflea
(Daphnia magna)
flow-through
%ai
99.95
33.21
48-hour LC50/
EC50 (ppm)
(measured/nominal)
0.027 (measured)
01049 ppm ai
(measured)
Toxicity Category
Very highly toxic
Very highly toxic
MRIDNo.
Author/Year
41605503;
Burgess, 1990
43052801;
Blakemore et
al., 1992
Since the LC50/EC50 falls in the range of <0.1 ppm, thiodicarb is very highly
toxic to aquatic invertebrates on an acute basis. The guideline (72-2) is fulfilled (MRID
56
1 A| nil 1.1 111 nfc
-------
"41605503,43052801).
Methomyl has been classified as very highly .toxic to freshwater invertebrates (48-
hour EC50 = 8.8 ppb).
d. Freshwater Invertebrates, Chronic
A freshwater aquatic invertebrate life-cycle test using the..TGAI is required for
thiodicarb since the end-use product may be expected to be transported to water from the
intended use site, and the pesticide is intended for use such that its presence in water is
likely to be continuous or recurrent. The preferred test species is Daphnia magna.
Results of this test are tabulated below.
Table 24 - Freshwater Aq
Species/Static
Renewal or Flow-
through)
Waterflea
(Daphnia magna)
static renewal
%ai
97.3
uatic Invertebrate Life-Cycle Toxicity
21-
dayNOEC/LOEC
(ppm)
0.009/0.018
MATC1
(ppm) ,
>0.009,
O.Q18
(0.0135)
Endpoints
Affected
Reduced number
of young per
female
MRIDNo.
Author/Year
00100688;Boothetal.,
1982
1 MATC = Maximum Allowed Toxic Concentration, defined as the geometric mean of the NOEC and LOEC.
In this freshwater aquatic invertebrate life-cycle study with thiodicarb the NOEC is
0.009 ppm and the LOEC is 0.018 ppm based on reduced number of young per female.
The MATC is 0.0135 ppm. The guideline (72-4) is fulfilled (MRID 00100688).
In a waterflea aquatic invertebrate life-cycle study, the data indicate that methomy 1
significantly reduced the number of young produced at concentrations greater than 0.4
ppb.
e. Estuarine and Marine Fish, Acute
Acute toxicity testing with estuarine/marine fish using the TGAI is required for
thiodicarb because the active ingredient is expected to reach this environment due to its
use in coastal counties. The preferred test species is sheepshead minnow. Results of these
tests are tabulated below.
57 .
-------
:!!', IS Ml 'Jlii'l I,
'll^'S^lft1,^1
'ii'1'! f&iM^jiii'iSji'iflr
!1 vat. 'Ijtttil.f :
' I
I
sfm HIE
isiKii iii
Table 25 - Estuarine/Marine pish Acute Toxicity
I1!
n ii
Species/(Static
or Flow-through)
Sheepshead minnow
(Cyprinodon variegatus)
flow-through
Sheepshead minnow
flow-through
Sheepshead minnow
flow-through
%ai
95.8
33.21
82.1
96-hour LC50 (ppm)
(measured/nominal)
0.53 (measured)
0.47 ppm ai
(measured)
0.49 ppm ai
(measured)
Toxicity Categoiy
Highly toxic
Highly toxic
Highly toxic
MRIDNo.
Author/Year
41891005;
Machado, 1991
42738501;
Sousa, 1992
42738502;
Sousa, 1992
Since the LC50 falls in the 0.1-1.0 ppm range, thiodicarb is highly toxic to
estuarine/marine fish on an acute basis. The guideline (72-3a) is fulfilled (MRID
41891QQ^42738501A 42738502). , , ' "_[ "
itfflt't'i'
•Kfi'iStfSKill v:!;'^./';-!!;'!
I'll mil yipfy,;; rmni,,!:, /i;/"! IIIIHT
Methomvl has been classified^ as moderately toxic to estuariiie/marine fish
-C5PU6 " " "' " '" ""
il' id1! • jt"'! ;i rii'titi ii j • 'ii i' i!'
life-stage toxiciry test using tiie TGAI is required for
I'tModicarb because the end-use product may be applied multiple times to the
estuarine/marine environment and in areas adjacent to or near estuairine habitats.
Thiodicarb may also be expected to be transported to this environment from the intended
use site, and the pesticide is intended for use such that its presence in water is likely to be
continuous or recurrent Thiodicarb is highly toxic on an acute basis and methomyl is
moderately toxic on an acute basis. Therefore, the life-stage tests are needed to determine
whether potential cnronic risks exist The preferred test species is sheepshead minnow.
The guideline (72-4) is not fulfilled.
inn (i iiiiiFi1'1 in
•iii ii i
An estuarine/marine fish life-cycle test using the TGAI may be required for
thiodicarb since the end-use product may be expected to transport to water from the
intended use site, and the following conditions are met: (1) the EEC is equal to or greater
than one-tenth of the NQEC hi the fish early life-stage or invertebrate life-cycle test, or,
(2) studies of other organisms indicate the reproductive physiology offish may be
affected. The preferred test species is sheepshead minnow. This requirement is reserved
pending review of a valid estuarine/marine fish early life-stage test.
g. Estuarine and Marine Invertebrates, Acute
Acute toxiciry testing with estuarine/marine invertebrates using the TGAI is
Required for thiodicarb because the active ingredient is expected to reach this environment
because of its use in coastal counties. The preferred test species are mysid shrimp and
m n ill in 11 in 1 ii»mi i in11 ill ii linn ilmiti n
58
-------
eastern oyster. Results of these tests are tabulated below.
, ^ >%r
Table 26 - Estuarine/Marine Invertebrate Acute Toxicity
Species/Static or
Flow-through
Eastern oyster
(shell deposition)
(Crassostrea virginica)
flow-through
Eastern oyster
(shell deposition)
flow-through
Eastern oyster
(shell deposition)
flow-through .
Mysid (Americamysis
bahia)
static
Mysid flow-thrbugh
Mysid flow-through
% ai.
95.8
33.21
82.1
94.5
33.21
82.1
96-hour
LC50/EC50 (ppm)
(measured/nominal)
1.0 (measured)
1.1 ppm ai
(measured)
0.55 ppm ai
(measured)
0.029 (measured)
0.10 ppm ai
0.075 ppm ai
Toxicity Category
Highly toxic
Moderately toxic
Highly toxic
Very highly toxic
Highly toxic
Very highly toxic
MRTONo.
Author/Year
41891006;
Dionne, 1991
42342501;
Dionne, 1991 -
42834001; '
Dionne, 1993
41891007;
Sousa, 1991
42738503;
Sousa, 1992
42738504;
Sousa, 1992
Since the LC50/EC50 falls in the range of O.029 -1.1 ppm, thiodicarb is
moderately to very highly toxic to estuarine/marine invertebrates on an acute basis. The
guideline (72-3b and 72-3c). is-fulfilled (MRID 41891006,4189100^ .42342501,
42834001,42738503,42738504).
Methomyl has been classified as practically non-toxic to highly toxic to
estuarine/marrne invertebrates (EC50>140 pprn/Threshold Level 50=4.9 ppm).
1 -s -
h. Estuarine and Marine Invertebrates, Chronic
An estuarine/marine invertebrate life-cycle toxicity test using the TGAI is required
for thiodicarb because the end-use product may be expected to be transported to this
environment from the intended use site, and the following conditions are met: (1) the
pesticide is intended for use such that its presence in water is likely to be continuous or
recurrent regardless of toxicity, (2) any aquatic acute LC50 or EC50 is less than 1 mg/1,
(3) the EEC in water is equal to or greater than 0.01 of any acute LC50 or EC50 value,
or, (4) the actual or estimated environmental concentration in water resulting from use is
less than 0.01 of any acute LC50 or EC50 value and any of the following conditions exist:
studies of other Organisms indicate the reproductive physiology of fish and/or
59
-------
Table 27 - Fate Properties of Thiodicarb and Methomyl.
Properties
Vapor pressure, mmHg (20 C)
Water solubility, ppm (25 C)
Henry's Law constant, atm-nrVmol
Hydrolysis tl/2 - pH5
Hydrolysis tl/2-pH 7 . ,
Hydrolysis tl/2 - pH 9
Aqueous photolysis tl/2
Soil Photolysis tl/2
Aerobic soil metab. tl/2
Anaer. Aquatic metab. tl/2
Koc
Thiodicarb
4.3xlO-5
19
l.lxlO-6
78 days .
• 32 days
12 hours
8 days
37 -days"
1.5 days
3 hours
485
Methomyl
S.OxlO-5
58,000
l.SxlO'10
stable
stable
30 days
1 day
36 days
45 days
<7-14 days
24'
1 The Koc value for methomyl is 42. The value used in the calculations was 24 (corrected for organic
matter). EPA believes that, given the variability inherent hi the environmental fate parameters and the
level of sensitivity of the existing models, the new value will not change the assessment.
Methomyl is more persistent than thiodicarb because it is more stable to hydrolysis,
particularly under alkaline conditions, and degrades more slowly under aerobic soil and
anaerobic aquatic conditions. The higher mobility of methomyl is reflected in the
differences in water solubilities and organic carbon adsorption coefficients (K^). Results
from a field dissipation study for thiodicarb showed that methomyl was present in higher
concentrations in the 75-90 cm soil zone than was thiodicarb. These findings are
consistent with the laboratory mobility data.
Thiodicarb has a low water solubility of 19 ppm at 25 °C. It hydrolyzes quickly
under alkaline conditions (tj/^0.5 days), but is more stable under neutral and acidic
conditions (t1/2=32 and 78 days, respectively). In all pHs, methomyl was the major
hydrolytic product, comprising 20 and 36% of the residues recovered in pH 5 and 7
solutions, respectively, at 30 days. In the pH 9 solution, methomyl increased rapidly to
66% of the recovered radioactivity at 1 and 3 days after treatment, then declined to 40%
at 14 days, and 19% at 30 days. '
Thiodicarb photodegraded moderately in the pH 6 solution with a half-life of 8
days. Methomyl, the major, photodegradation product in water, increased from 7% of the
applied at 1 day, to 24% at 7 days, then to 47% at 23 days. In contrast to the moderate
direct photolysis hi water, thiodicarb was relatively stable to photodegradation on a sandy
loam soil (t1/2=37 days). Methomyl was the major photodegradation product detected on
61
-------
The low octanol/water partition coefficient (Kow=30) suggests that thiodicarb will
have a low tendency to accumulate in fish. A fish bioaccumulation study confirmed that
thiodicarb does not accumulate in fish at a significant level upon exposure.
Bioconcentration factors were 4.1x, 7.1x, and 5.7x for edible tissue, nonedible tissue, and
whole fish, respectively. Acetic acid was the major degradate identified in the fish tissues,
comprising 34.5% of the recovered residues in the Day 21 fish tissues and 21.6% in the
Day 35 fish tissues. The 21-day nonedible tissue was the only fraction in which thiodicarb,
methomyl oxime, and methomyl were identified; each comprised 0.9-1.4% of the
recovered residues. After 28 days of depuration, 46-74% of the accumulated residues
were eliminated from the fish tissues. .
Droplet size spectrum (201-1) and drift field evaluation (202-1) studies were
required for thiodicarb since the chemical may be applied by aircraft and'due to concerns
for potential risk to nontarget aquatic organisms. However, to satisfy these requirements
the registrant and other registrants of other pesticide active ingredients formed the Spray
Drift Task Force (SDTF). The SDTF has completed and submitted to the Agency its
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. While these data are being
reviewed the Agency is relying on previously submitted spray drift data and the open
literature for off-target drift rates. The rates are 1% of the applied spray volume from
ground applications and 5% from aerial and orchard airblast applications at 100 feet
downwind. After its review of the new studies the Agency will determine whether a
reassessment is warranted. '
A field dissipation study conducted in a sandy loam soil in Washington showed
that thiodicarb dissipated with a half-life of 18 days after six weekly applications of 1.0 Ib
ai/A per application. Thiodicarb and its degradate, methomyl, appeared to leach rather
than accumulate in the soil from repeated applications. Very small amounts of thiodicarb
(3 ppb) were detected immediately after the fifth application in the 75-90 cm soil zone.
Low levels of methomyl were also detected in the 75-90 cm soil zone: 1 ppb after the
fourth application, 4 ppb after the fifth application, and 1-3 ppb 7 and 14 days after the
last of six applications. Furthermore, results from this study showed that the degradate,
methomyl, was more commonly detected in lower horizons than the parent compound.
These findings are consistent with the laboratory mobility data that indicate that methomyl
is expected to be more mobile than thiodicarb in the environment.
2. Terrestrial Exposure Assessment
The terrestrial exposure assessments following single applications, shown in the
table below, are based on the methods of Hoerger and Kenaga (1972) as modified by
Fletcher et al. (1994). Uncertainties in the terrestrial EECs are primarily associated with a
lack of data on interception and subsequent dissipation from foliar surfaces. EFED
63
-------
,
11 i'llRiSii' ........ ,| .iif'J!" ill* !apim!,l!:', <:! liil!1/;,!!!,!! Ifii .''II ....... !' I'1''!1"!1",,,, 'Si,! ..... Hi!;!!!"!':1'!'1"!! ;!!'"! ',„ ! ' !> illry11';1!! ,':, ..... h ..... ....... IT 'i
......... fjra ....... rr-iu ........ wKJfti'fl ...... KM ..... uLtt'.w^Yj ...... w^'-iv1 ..... .•?',., .
fj:'">\« SJP ^ JUilJ '' *!i!lf !• ''.I "r i!i:
1 !' : :!l!!!ii:il!il'1|!i'i:iCll1|ii,,|i.l!l!!,illi,ll!Eli;iil!i!l!!iill!|!iii'1i|i ll
liKtlTlto^^ 'fillllW11-^iLLiiliiliiilliiM iilLSiiLniiiiiilniii m iiiiyilUlilllin I
V .' :(;l:i!!| Ml iillft'f' 'if1.!1'1]!"!! "UBI™ ii) ill ":~ "Iti 0*KMB •HwHM I
tCwi:M' tlM ItwaS: • -II if?,:,",; ,•;.•• ins11::•• i i;"'!1; ;•".,;: s •,$$i£S!XSSSfi,SSSii:£S I
I; !„,:.. ;Fll|Bi!i
" S'llli1 .( •'• ..... !' ID 1? iflij :"tt "
is ! ...... ii« ...... i, 'in;,,1 • iiiiiiii ii; ..... i,;'"! i-J
ill1!:!,,- SI :; ...... mil! i'K !>W ! ;:liS ...... !'
if'.!"!"!;:', WA lai'.i'iiiiiiiiiiiiiii ' i . "f vi ........... '.A
• ..... Blffi :, ; > •!;' ! (. ,,K, ...... ':!,• X ........ I! ..... i? i'": • I ..... v -> "t: ' ; ........ ! :: " B"!:S.t" S;f3:: Mif. filvlinti • • ..... *T "S11," ,: JirK 1 -S. :J :; '• ; ; ! i'" :
i, ...... I ..... n:i i*1.1'!1 »M,t i|lM!i:,i,;]|i,,il!V;iiil! .......... dwvi .' ;i-t »;, it : ' t ant »':•* ; '*&&<', it -i ........ nit ..... ™ iiirrf"1.1" vj • ..... « " •* ............ .'""' ...... "
- ""'«' ..... n* .............. t*.1 ...... • ........ i ..... '"'•<
1 11 ii ilillllllillllllli lii i 1 Hi 111 I 111 111 11 H »'a^ia«^*'ii:*i,i^;.'.lrii ;:»:| iiiLait^ii* tlll-Ji^^^^ ,;!'!' |
assumes that the foliar dissipation rate is equal to the aerobic soil metabolism rate. Open
literature data suggest that foHar'dlsapation'rates'are gener^Hy ]ess •
Hoerger-Kenaga estimates of day 0 residues are based on residue data correlated
from .more than ,20 pesticides on more than 60 crops. They are representative of many
geographic regions (7 states) and a wide array of cultural practices, Hoerger-Kenaga
estimates also considered differences in vegetative yield, surface/mass ratio and
interception'factors. In 1994, Fletcher, Nellessen and Pfleeger, reejcamined the
Hoerger-Kenaga estimates to determine whether the terrestrial EECs were appropriate
:;estimateg: ........... They compiled a dataset ^of pesticide^ day-0 and residue-clecay data^ iinyolving
, SBi. :/PeciGS, ° plants. After analyses, their conclusions were that ,
r-K.enaga estimates needed only "minor modu'ications to elevate the predictive
'J^^!!!!!!'^; ;, SwSfflsfeisge and firiit categories from 58 to 135 and from 7 to 15, respectively.
' ^resglting from a single application, for avian and mammalian food items, for
1 lb. ai/A are in the table below.
Table 28 - Estimated Environmental Concentrations on Avian and Mammalian Food Items Following a Single
Application of 1 lb. ai/A (Hoerger and Kenaga, 1972, as modified by Fletcher et al, 1994)
Food Items
Short grass
Tall grass
Broadleaf plants and small insects
Fruits, pods, seeds, and large insects
EEC (ppm)
Predicted Maximum Residue
240
110
135
15
EEC (ppm)
Predicted Mean Residue
85
36
45
7
l"™;™;:;:;-'". :^' .^T:.^-™:.;:: , For multipje apj3h"cati_pns, EEC's, ishown in the table below, 'were derived from
,,, i
' Terrestrial exposure calculations incorporated simultaneous degradation
exposed to both chemicals in their diet in
kjBs. treated with multiple applications of thiodicarb. This method is given below.
[2]
pn=
D=
Ii||
-------
D0= daughter (methomyl) concentration at day 0
Dn = daughter concentration n days after application
Kj = decay rate for the parent (thiodicarb), 0.46 day"1
K2= decay rate for the daughter (methomyl), 0.02 day!
Table 29 - Maximum EEC's (in ppm from Fletcher et al., 1994) for thiodicarb and methomyl using
calculations incorporating simultaneous degradation scenarios for both compounds.
Crop
Gole
Cotton
, Corn
Soybean
Leafy vegetable
Compound
Thiodicarb
Methomyl
Thiodicarb '
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Short grass
EEC
507
1245
256
1010
389 '
1496
182
521
277 "
313 .
Tall Grass
EEC
232
571
117
463
178
685
84
239
127
143
Broadleaf Plant
EEC
285
701
144
568
219 •
841
103
293
156
176 .
Fruit/ seed EEC
32
79
16
63
24
93
11
33
17
20
3.
Water Resource Assessment
a.
Ground Water
According to the U.S. EPA 1992 Pesticide in Ground Water Database, detections
of thiodicarb hi ground water have not been reported. This database shows detections of
methomyl in Missouri, New York, and New Jersey at concentrations up to 20 ppb.
The final report for the methomyl small-scale prospective ground-water monitoring
study conducted at a sweet corn site in Cook County, Georgia found that methomyl was
sporadically detected at concentrations ranging from 0.1-0.4 ppb hi ground water. This
study confirms the previous findings that methomyl (the major degradate of thiodicarb) is
persistent and has a potential, to contaminate ground water.
b.
Surface Water
Thiodicarb may reach surface water by spray drift during aerial application or by
runoff after application. Substantial fractions of applied thiodicarb may be available for
runoff for a few days to several weeks after application. The relatively low soil/water
partitioning of thiodicarb suggests that off-site transfer will generally occur primarily via
dissolution in runoff water as opposed to adsorption to eroding soil.
65 .
-------
collected from the 27 sites from November 1988 through November 1993. Methomyl was
detected (detection limits ranging from 1.9 to 20 ppb) in only one sample at a
concentration of 1.9 ppb.
In 1994, Washington State collected surface water samples in April, June, and
October from 8 sites (for a total of 24 samples) and analyzed them for multiple pesticides
including methomyl. Methomyl was not detected in any of the samples above an >
approximate quantification limit of 0.04 ppb. However, methomyl was detected at a -
concentration of 0.09 ppb in a 1993 sample collected from a site (Salmon Creek) which
was not resampled in 1994.
The relatively low soil/water partitioning of thiodicarb indicates that it will
probably not be effectively removed by the primary sediment removal treatment processes
employed by many surface water supply systems. However, thiodicarb is not currently
regulated under the Safe Drinking Water Act (SDWA) and the Office of Drinking Water
has not issued a Maximum Contaminant Level (MCL) or a Health Advisory Level (HAL)
for it.
The relatively low soil/water partitioning of methomyl indicates that it will
probably not be effectively removed by the primary sediment removal treatment processes
employed by most surface water supply systems. Methomyl is not regulated under the
SDWA and no MCL has been established for it. However, the Office of Drinking Water
has established one- and ten-day HALs of 300 ppb and a lifetime HAL of 200 ppb for
methomyl. - :
4. Aquatic Exposure Assessment
Estimated Environmental Concentrations (EECs) in the aquatic environment were
generated both for the parent thiodicarb and the major degradate methomyl.
Environmental fate studies indicate that thiodicarb rapidly degrades to methomyl, with few
other degradates present. For a Tier 1 assessment, an almost immediate and complete
degradation of thiodicarb to methomyl was assumed. For a Tier 2 assessment
(PRZMfliXAMS), an 80% conversion was used (based on results of an aerobic
metabolism study) which showed that;the half-life of thiodicarb was 1.5 days in the soil
tested.
i . -
For a Tier 1 assessment, the Agency uses GENEEC, a screening model that
provides an upper-bound estimate of environmental concentrations (EECs) on a high
expbsure site. The GENEEC program uses basic environmental fate values and pesticide
label information to estimate the EECs in a one-hectare, two-meter deep pond following
the treatment of a 10 ha 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. The
67
-------
Ill III III I 111 I ill
111 III II11IIIII 111 III III
model also accounts for direct deposition of spray drift onto the water body (assuming 5%
of the application rate for aerial spray applications and 1% for ground spray applications).
Table 30 - Environmental fate parameters used to predict thiodjcarb and methomyl EECs:
'fl
•[
Parameter
water solubility (ppm)
Koc (avg)
aerobic soil metabolism, tl/2:
hydrolysis tl/2, pH 7
aerobic aquatic metabolism, tl/2
aqueous photolysis tl/2
Thiodicarb
19
485
1.5 day
32 day
n/a
8 day.
Methomyl
58,000
24'
45 day
stable
n/a
1 day
I:;;1;, —; :::,: .i^;.!The_Koc_xalue_forme^^[iyl: is 42. The value used in the calculations was 24 Corrected for organic
'- '" «•• ; i *'*«* •" i™^^^ SA Believes that;,1 given the variability inherent in the environmental fete parameters and the
[g||gn||iYity of the existing models, the new value i will |not change the assessment. ,
iiiii'iiiiii'iiLi'iiniipiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiriiiiiii'iiiiiiEiiiiiiiinii i;': jinuii ii'ipii' 11 n 'iniiiuiiH'iiiUuiL inij ii ii iiiniiii.'iii < H, i'!ii,,,i', in' pin ,'i»'i: iiiiiii'.i "i', i I'liiiiiiPiiiii ii" RiiPi'iiiiii .iiPiiui.'jiyiiiiiiiiiPi.iviiiiHip i!iiiiiiiiiiiii|iP"iii. : ,i, i.pniPHiiii,' il'* iiiipini',; i;,,,' ii,; PI,,I mi,:::,;:::,' 1:1, ' ir i ,:„'',:: n,',:,! „' ,i 7 ,:;, i, , „::'"!:,,'< i, i1',,1:::1,:
; jpodicai|> afongj detemdned, uang GE§^EEC, .ranged from 22 to 65 ppb
,,. , , ;, ' , ,;,„ „' J1a,ss,£,n,,sss!,==s.jf—c concentrations and from 11 to 32 ppb for 56-day average concentrations.
i degrading from thiodicarb, the jgg(js ranged from 76 to 352 ppb for initial
concentrations and from 65 to 301 ppb for 56-day average concentrations. Most
RQs) calculated using the Q|^SJ|?]E?C EECs exceeded the LOCs.
Tnerefore, refined aquatic concentrations (Tier 2 assessments) were calculated using
, " ' ' "''',• r '"• ; „ r ;_, _ I, |
The Agency uses environmental fate and transport computer models to calculate
refined EECs. The Pesticide Root Zone Model (PRZM2) simulates pesticides in field
runoff on daily time steps, incorporating runoff, infiltration, erosion, and
evapotranspiration. The simulation is run on daily tune steps where runoff is estimated
daily rather than on a yearly, hourly, etc. basis.. The model calculates foliar dissipation and
runoff, pesticide uptake by plants, microbial transformation, volatilisation, and soil
dispersion and retardation. The Exposure Analysis Modeling System (EXAM II)
simulates pesticide fate and transport in an aquatic environment (one hectare body pf
water, two mefers <$£$). EECs ^'i^g^j-^ g^-g^;^- t^ble!
, ^ ,,.,.,.
" "!'
ill ill II IIIIIII 11 III I II Mil \\iiM II II I III Mill I I I I II I III III II I III I ill 11 I i
-' " t.
I
j r
mi i • i iiiiiii iiiii i in i i n i j I ii | |i
" i,
i
" ""'"' '"'""' "" ''"" '"' ' "Ii
" '•• , /*o
„, | ,1li!i!|.,ii', "Miliiiii'l^lLiJi1;!'!!*!:!''^"!!!!!,!11,,,::1,'11 ,""
«'l [.ij!' ' '^'IJiiiili ii:::
(111
I
-------
Table. 31 - Tier 2 (PRZM/EXAMS) Simulated EECs for Thiodicarb and Methomyl
Crop/
State
Corn,
IA
Cotton,
MS
Soybeans,
MS
Leafy Veg.,
FL
. Chemical
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Maximum
EEC ug/L
23
42
21
151
9
41
5
' 24
96 Hour
EEC ug/L
22
42
19
149 '
8
41
5
'24
21 Day
EEC ug/L
18
40
17
141
7
40
4
23
60 Day
EEC ug/L
12
37
12,
129
5
37
3
' 23
90 Day
EEC ug/L
10
34
9
120
4
35
2
22
The refined EECs, estimated by PRZM/EXAMS, ranged from 12% (for corn) to
63% (for cotton) of the EECs estimated using GENEEC. These EECs were used to
calculate the risk quotients (RQs) in the Risk Characterization section.
£. Environmental Risk Assessment
The results of exposure and ecotoxicity data are integrated using the quotient
method. For this method, risk quotients (RQs) are calculated by dividing exposure
estimates by ecotoxicity values^ for both acute and chronic effects.
RQ = EXPOSURE/TOXICITY
RQs are then compared to OPP's levels of concern (LOCs). These LOCs are
criteria used by OPP to indicate potential risk to nontarget organisms and the need to
consider regulatory action. The criteria indicate that a pesticide used as directed has the
potential to cause adverse effects on nontarget organisms. LOCs currently address the
following risk presumption categories: (1) acute high - potential for acute risk is high,
regulatory action may be warranted in addition to restricted use classification (2) acute
restricted use - the potential for acute risk is high, but this may be mitigated through
restricted use classification (3) acute endangered species - the potential for acute risk to
endangered species is high, regulatory action may be warranted, and (4) chronic risk - the
potential for chronic risk is high, regulatory action may be warranted. Currently, the
Agency does not perform assessments for chronic risk to plants, acute or chronic risks to
nontarget insects, or chronic risk to mammalian or avian species from granular/bait
formulations. -
" The ecotoxicity test values (i.e., measurement endpoints) used hi the acute and
chronic risk quotients are derived from the results of required studies. Examples of
ecotoxicity values derived from the results of short-term laboratory studies that assess
acute effects are: (1) LC50 (fish and birds) (2) LD50 (birds and mammals (3) EC50
69
-------
!"]',<
11! iii'!1:,,,!
i1 i ;„, iiiif f
«,
filLil |! !' hiiiili, '"i" I, '
' 'Bill I,: ¥< \ ' >\V :. I:!,1 Itiffi!':/!
•iiif'Tiiw;"1;1!!"!!1;!!!
SSS'ii
f ii;,1!*!1!^,; iliMi'i'i
':;^
II
11)1
(aquatic plants and aquatic invertebrates) and (4) EC25 (terrestrial plants). Examples of
toxicity test effect levels derived from me results of long-term laboratory studies that
assess chronic effects are: (1) LOEC (birds, fish, and aquatic invertebrates) (2) NOEC
(birds, fish and aquatic invertebrates) and (3) MATC (fish and aquatic invertebrates). For
birds and mammals, &e NOEC vdjre^isjused asjflbe ecotoxicity test value in assessing
chronic effects. OtherLvalues may be used when justified Generally, the MATC (defined
as the geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in
assessing chronic effects to_fish_and aquatic mvertebrates. However, the NOEC is vised if
the effect is production of offspring or survival.
Risk presumptions, along with the corresponding RQs and LOCs for terrestrial
animals, aquatic animals and plants are tabulated in the following tables.
Table 32 - Risk Presumptions for Terrestrial Animals
!19^^
jiiliflilir^ r'iiiPi/
mm i!:^
i;Hlli:«ii|ii|!;;iiliilj!lillliii;iti;<':>ai4 >n ;
iilli!: •TlBit'^BiiB'nsffi*;
«ii,.ulh !""•«"! IT - !»"„," .."»
::::::: ':::':„::"::"„'; :„,"::„: ,„"',":„",
Risk Presumption
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
Acute High Risk *
Acute Restricted Use
Acute Endangered Species
Chronic Risk
RQ
Birds
EEC VLC50 or LD50/sqft2 or LD50/day3
EEC/LC50 or LD50/sqft2 or LD50/day (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft2 or LD50/day
EEC/NOEC
EEC/LC50 or LD50/sqft2 or LD50/day
EEC/LC50 or LD50/sqft2 or LD50/day (or LD50 < 50 mg/kg)
EEC/LC50 or LD50/sqft2 or LD50/day
EEC/NOEC
LOG
0.5
0.2
0.1
1.0
0.5
0.2
0.1
1.0
1 abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items
3 mg of toxicant consumed/day
LD50 * wt. of bird
LD50 * wt. of bird
Table 33 - Risk Presumptions for Aquatic Animals
Risk Presumption
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
RQ
EECVLC50orEC50
EEC/LC50orEC50
EEC/LC50orEC50
EEC/MATC or NOEC
LOG
0.5
0.1
0.05
1.0
70
-------
Table 34 - Risk Presumptions for Plants
Risk Presumption
RQ
LOG
Terrestrial and Semi-Aquatic Plants
Acute High Risk
Acute Endangered Species
EECVEC25 .
EEC/EC05orNOEC
, 1.0
1.0
Aquatic Plants
Acute High Risk
Acute Endangered Species
EEC2/EC50
EEC/EC05orNOEC
1.0
1.0
EEC = Ibs ai/A
2 EEC = (ppb/ppm) in water
71
-------
iH^^^ ..... !i
' ..... ' ...... i ............. -Kin Hi],' >| ..............
' ..... ' ..... :;
........... n ...... ' ............ ; ................... • .......... , ...... .................. l ...... ................. i .............. llii|i|
::i^
! ! ..... " i'1"1 • !,! " '' \ I : if,",, !'i,' I,;;,!!!' • ' , Y I'll ',, , 4 ,', ft , 'i 'Ji 1 j" ,„ ...... ;;;;> ; d , ;; ..... lliijinjjlf | ^ viijji; {h|' v , ijij
:,*^i ..... f!i;,«
' ' ' '' " 1 1
| ££ ........... !!!l;|!|g«[ fc i " in ™ a ..... R » ' JJ „ ,„ , „ ,; • ...... , pj* • m j' • » $*, mi ..... fftf l!li"J«Il
..... 44M0 ...... *w^pii4mta
< i.lllir'rillllllllllPlElipviiriiPPP'illlllI'Lllllllllllllili. 'I '''PI'i "iin :IIIIIIIIIPP«liiiliPi 'illiMil'1 Cfib'TPIIIU11 <*iU l|l|l;!ll!!|l|::::il"!!!ll!!55l l-Bili.^^^^ 'L!l "", P 1 ' iJiiiltlllllrF .'ll I I ,"".,i'":i ' l< 11 Ml, VJ' :,i I" I iKI!" i1 II1 J" ,||' 'IJKillllllllllli,,! • felilliwi' • • I'll ••BiljU1' j> "l:'< i.W" • * wl^niiii;!!Li!|ii||i!iLi|iiii!!!ipI
t^jrl i: ;:-T- ;. :ii\ "^ H'"i':, r;f '= "1. , Exposure and Risk to Nontarget Terrestrial Animals
The following tables identify the risk quotient values for thiodicarb and methomyl
for nontar^et terrestrial animals for each crop or representative crop at the daily maximum
. rate for that crop.
• lll'iliiiillllilllnlll'i1 I'lllPH I UH'"',1
i'iM
iTSSi'i *^4iK'tli»^«lftft^'**^Ki1'wV-r iiriiit l liiiiTi'iKiiJiiu IIIIIII
' ':':«' m' ill ' I
'niW^^^^^ 'til 3,
tops: The Estimated Enykonmental Concentrations '.(EEC's m ppm) are based on
,, „„ ,7 ^^W^S^^S^imB^SS&l^^^'^.^y i »>
=E::;,:=:r:::i,,M^4 applications for 6 days, which is the maximum rate for cole crops. They incorporate
Sfi^ijSf^gradation rates of 1.5 days for thiodicarb and 30 days for methomyl (see Table 29).
WjiHiiSi'1!!
IIF,:,..!!! •,
"IjIPPI' Nil" I
Table 35 - Risk Quotients for Nontarget Terrestrial Animals From Cole Crop Use
11,1'ijM
1 1 I'll "i' IliJIlill'iHIh''! "i "Hi1' KliPi'i:"" Jlllini''"!.!"1
iiifti ii'|il!'liliiilI4iW llKiil.,1;
iniPr^Jflll^lilPilillJiiinii.'!!-!'''!'!!!11 liiftLli-i,
:
• Siin^^^^^^^^^^^ :
iiifin^^^^^^^^^^^^^^^^^^
il^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
lllBillilHB^^^^^^^^ HE H'l'liEli'iMI
^i"*
'llii^iiiiijaiiiiniiii^^
'''W'llllfl^ V'l'il 'ii.'l'
nlllPi 11 * III nillllHIIH II" IPlKlRIIIIPI1 JiK'li'Ulll1 Ml,,1;
l!"1||l|!l!iil1' l!ll"*™* HHi •' ' '
llllMliiiliiiii^liriijiillil'IIIFilllilillil'iiiiiJiiillP''!!!!!!!!!!!!!!1 ""iPW, Lull
|iiiiiiii!:iiiHiiiii:tii!iii:i:»':::•* .-i^
jp^^ i H^^^^|^^^^^^^^^^^^^^^^^^^^^^^^^^
i ini
lii^ '
wnnniiiwn^^^^ :ii nil 'fi ii ii
Species, Risk
Avian, Acute
Avian, Chronic
Mammal, Acute
Mamma!, Chronic
Compound
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
EEC (ppm)
507 (short grass)
. 1245 (short grass)
571 (tall grass)
701 (broadleaf plant)
79 (fruit/seed)
507 (short grass)
232 (tall grass)
1245 (short grass)
571 (tall grass)
701 (broadleaf plant)
79 (fruit/seed)
507 (short grass)
232 (tall grass)
285 (broadleaf plant)
32 (fruit/seed)
1245 (short grass)
571 (tall grass)
701 (broadleafplant)
79 (fait/seed)
507 (short grass)
232 (tall grass)
285 (broadleafplant)
32 (fruit/seed)
1245 (short grass)
571 (tall grass)
701 (broadleafplant)
79 (fruit/seed) .
Toxicrty1
>5620
1100
500
50
506.7
340
100
75
RQ2
0.09
1.13 ***
0.52***
0.64 ***
0.07
1:01 +
0.46
24.9 +
11.4 +
14.0 +
1.57 +
1.0.0***
0.46 **
0.56 ***
0.06
3.7***
1.7***
2.1 ***
0.23 **
5.1 +
2.3 +
2.9 +
0.32
16.6 +
7.6 +
9.3 +
1.05 +
1 Acute toxicity values are the dietaiy LC50, except for the acute mammal. For thiodicarb, this is based on LD50 (mg/kg) = 76 ppm / % body weight
pnsumed (15%) for a mouse. For methomyl, this is based on LD50 (mg/kg) = 17 ppm / % Body Weight Consumed (5%) for a rat Chronic toxicity
allies are based on the NOEC from the reproductive studies.
! !» ffl* exceeds acute high, acute restricted and acute endangered species LOCs.
** exceeds acute restricted and acute endangered species LOCs.
4- exceeds chronic risk LOG
72
iiiiiii i
•ii i mi ii i ii ini i iin i i i i
-------
Cotton: The Estimated Environmental Concentrations (EEC's in ppm) are based on maximum
initial values for thiodicarb from Fletcher et al., (1994) resulting from .daily 0.9 Ib ai/A applications
for 6 days, which is the maximum rate for cotton. They incorporate degradation rates of 1.5 days
for thiodicarb and 30 days for methomyl (see Table 29).
Table 36 - Risk Quotients for Nontarget Terrestrial Animals From Cotton Use
Species, Risk
Avian, Acute
\ '
Avian, Chronic
Mammal, Acute
Mammal, Chronic
* •
Compound
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
EEC (ppm)
256 (short grass)
1010 (short grass)
463 (tall grass)
568 (broadleafplant)
63 (fruit/seed)
256 (short grass)
1010 (short grass)
463 (tall grass)
568 (broadleafplant)
63 (fruit/seed)
256 (short grass)
117 (tall grass)
144 (broadleafplant)
"16 (fruit/seed)
1010 (short grass)
463 (tall grass)
568 (broadleafplant)
63 (fruit/seed)
256 (short grass)
117 (tall grass)
144 (broadleafplant)
16 (fruit/seed)
1010(shortgras£)
463 (tall grass)
568 (broadleafplant)
63 (fruit/seed)
Toxicity1
5620
1100
500
50
506.7
340
100
75
RQ2.
0.05
0.92 *** -
0.42***
0.52 ***
0.06
0.5 +
20.2 +
9.26 +
11.4 +
113 +
0.51 ***
0.23 **
0.28 ***
0.03
'3.0***
1.4 ***
1.7 ***
0.19**
2.6 +
1.2 +
1.4 +
0.16
13.5 +
6.2 +
. 7.6 +
0.8 ^
Acute toxicity values are the dietary LC50, except for the acute mammal. For thiodicarb, this is based on LD50
•(mg/kg) = 76 ppm / % body weight consumed (15%) fora mouse. For methomyl, this is based on LD50 (mg/kg) =
17 ppm / % Body Weight Consumed (5%) for a rat. Chronic toxicity values are based on the NOEC from the
reproductive studies. ,
***
**
exceeds acute high, acute restricted and acute endangered species LOCs.
exceeds acute restricted and acute endangered species LOCs. -
exceeds chronic risk LOG
Corn:The Estimated Environmental Concentrations (EEC's in ppm) are based on maximum initial
73
-------
t> Q?94) resulting, from daily 0.75 Ib ai/A applications for
. ,
10 days, whch is the maximum rate for corn. IThey incorporate degradation rates of 1.5 days for
thiodicarb and 30 days for methomyl (see Table 29).
Table 37 - Risk Quotients for Nontarget Terrestrial Animals From Corn Use
i |in linn ill
»^^^^^^^^^^^^^^^^^^^ ;! i ,
.MM3i
JjjjjjK
ji1' TJiV"1 iii'iii iiiiB;i"iii : run ii. ill.'!,
iliiiJiiiiiluiiiiiiiiiiit'lilSlP^
11 iiiiiiKliiiii
llli'lllilii'lKlllllllinllllllllllllllilill'liill!' •iHllpiiiliJii'IPPlfl'.,
iJT"1 ii'ipii i1 iiii1 i ]'" ii'ii I; I; Si ii1 , ii
r"!mnr!r"7« *'J!!r
l!Jj^^ ^'il1!1*;!,:!
iiin>!iiii"P!i|ip|P«pMlh«n"Pi»«ri! 'liii'iiraiiiirjii'ini yc „
''**£=r:T*Z;'5";
Species, Risk
Avian, Acute
Avian, Chronic
Mammal, Acute
Mammal, Chronic
Compound
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
EEC (ppm)
389 (short grass)
1496 (short grass)
685 (tall grass)
93 (fruit/seed)
389 (short grass)
1496 (short grass)
685 (tall grass)
93 (fruit/seed)
389 (short grass)
178 (tall grass)
24 (fruit/seed)
1496 (short grass)
685 (tall grass)
93 (fruit/seed)
389 (short grass)
178 (tall grass)
24 (fruit/seed)
1496 (short grass)
685 (tall grass)
93 (fruit/seed)
Toxicity1
5620
1100
500
50
506.7
340 ;
100
75
RQ2
0.07
1.4 *** '
0.62 ***
0.09
0.78
29.9 +
13.7 +
1.9 +
0.77***
0.35 **
0.05
4.4 ***
2.0 ***
2.5 ***
0.28 **
3.9+ '
1.8 +
0.24
19.9 +
9.1 +
11.2 +
1.3 +
'Acute toxicity values are the dietary LC50, except for the acute mammal. For thiodicarb, this is based on LD50
(nig/kg) s 76 ppm / % body weight consumed (15%) for a mouse. For methomyl, this is based on LD50 (mg/kg)
17 ppm / % Body Weight Consumed (5%) for a rat. Chronic toxicity values are based on the NOEC from the
reproductive studies.
*** exceeds acute high, acute restricted and acute endangered species LOCs.
** • exceeds acute restricted and acute endangered species LOCs.
•+ , exceeds chronic risk LOG ; ' ..'
,, (((• •
yIIIIIIIIIIIIIIH^^^^ Bin nil "IIIfliif-n i1, liiiiiB 1111 •+, ,•'.«: i m ior,! jn ,!< w: niDi1' K1 B
im!IKiVJtt£!&&& vegetables: The Estimated Envkormental Cpncentrations QEEC's 'in ppm) are based on
• illltjlljijji LUE !|i,i IIK
la (1994) resulting from daily 0.75 Ib ai/A
1 lil! *^[*^^^^i for2 dajs, wEcE^Sernajdmurnrate for leafyivegetables. Tfcujyincorporate
. rates of 1.5 days for thiodicarb and 30 days for methomyl (see Table 29).
Si"'1 liiiiijliiii'iiilii1 ' ' i' ISiiiiiii 1 .'
'i>i>jiiii|i' :> 'S'SK ..... wiSjiKliiiBB
ill111H1B t is i > iiiiiii«;;iin iiEiiiii!1!)!:1!!:"1! IHT . ii"' iiiiiii ':i>!
• f
-------
Table 38 - Risk Quotients for Nontarget Terrestrial Animals From Leafy Vegetable Use
Species, Risk
Avian, Acute
Avian, Chronic
Mammal,,Acute
Mammal, Chronic
Compound
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
Thiodicarb
Methomyl
EEC (ppm)
277 (short grass)
3 13 (short grass)
143 (tall grass)
176 (broadleaf plant)
20 (fruit/seed)
277 (short grass)
313 (short grass)
143 (tall grass)
176 (broadleaf plant)
20 (fruit/seed)
277 (short grass)
127 (tall grass)
156 (broadleaf plant)
17 (fruit/seed)
313 (short grass)
143 (tall grass)
176 (broadleaf plant)
20 (fruit/seed)
277 (short grass)
127 (tall grass)
156 (broadleaf plant)
17 (fruit/seed)
3 13 (short grass)
143 (tall grass)
176 (broadleafplant)
20 (fruit/seed)
Toxicity1
5620
,1100
500
50
50617
340
100
75
RQ2
0.05
0.28 **
0.13*
0.16 *
0.02
0.55
6.3 +
2.9 +
3.5 +
0.4
0:55 ***
0.25**
0.31 **
0.03
0.92 ***
0.42**
0.52 ***
0.06
2.8 +
1.3 +
1.56 +
0.17
4.2 +
1.9 +
2.3' +
0.27
Acute toxicity values are the dietary LC50, except for the acute mammal. For thiodicarb, this is based on LD50
(mg/kg) = 76 ppm / % body weight consumed (15%) for a mouse. For methomyl, this is based on LD50 (mg/kg) =
17 ppm / % Body Weight Consumed (5%) for a rat Chronic toxicity values are based on the NOEC from the
reproductive studies.
*** exceeds acute high, acute restricted and acute endangered species LOCs.
** exceeds acute restricted and acute endangered species LOCs.
* exceeds the endangered species LOG
+ exceeds chronic risk LOC
75
-------
moderately to highly toxic to small mammals on an acute oral basis. Methomyl is highly
toxic to birds arid mammals on an acute oral basis but only slightly toxic to birds on a
subacute dietary basis. Thiodicarb may result in chronic risks to certain species that
frequent short grass (e.g, ducks, geese and swans). Methomyl, as a degradate, poses
acute risks to birds and mammals that feed on short and tall grasses, broadleaf plants, and
small insects. Methomyl also poses potential chronic risks to birds and mammals,
primarily due to the build-up of the chemical from multiple applications of thiodicarb at
short intervals. , ,
2. Exposure and Risk to Nontarget Freshwater and Marine Aquatic
Animals
The following tables identify the EEC values for acute and chronic risk from the
maximum PRZM/EXAMS values (see Table 31). For chronic risk, the 21-day EECs are
used for invertebrates and the 60-day EECs are used for fish. Application rates are the
same as those used in the terrestrial risk assessment.
Table 40 - Risk Quotients for Aquatic Animals From Corn Use
Species
Freshwater fish
Freshwater
invertebrate
Marine fish
Marine invertebrate
compound'
T(A)
M(A)
T(C) ,.
M(C)
T(A)
M(A)
T(C)
M(C)
T(A)
M(A)
T(A)
M(A)
EEC (ppm)
0.023
0.042
0.012
0.037
0.023
0.042
0.018
0.040
0.023
0.042
0.023
0.042
Toxicity
1.47
0.5
0:036
0.057
0.027
0.008
0.0135
0.0004
0.53
1.16
0.029
0.23
RQ2
0.02
0.08 *
0.33
0.65
0.85 ***
5.3 *** -
1.3 + , -
100 +
0.04
0.04
0.79 ***
0.18 **
1 T= Thiodicarb M= Methomyl (A)= acute (C)= chronic
2 *** exceeds acute high, acute restricted and acute endangered species LOCs
** exceeds acute restricted and acute endangered species LOCs
* exceeds the endangered species LOG
+ exceeds chronic risk LOG ' ,
77
-------
!,,,,, .^
iiN^^^^^ I
i HiiiijJiBii (ill iiiirjiiii. it
ble 41 - Risk Quotients for Aquatic Animals From Cotton Use
Species
Freshwater fish
Freshwater
invertebrate
Marine fish
Marine invertebrate
compound1
T(A)
M(A)
T(C)
M(C)
T(A)
M(A)
T(C)
M(C)
T(A)
M(A)
T(A)
M(A)
EEC (ppm)
0.021
0.151
0.012
0.129
0.021
0.151
0.017
0.141
0.021
0.151
0.021
0.151
Toxicily
1.47
0.5
0.036
0.057
0.027
0.008
0.0135
0.0004
0.53
1.16
0.029
0.23
RQ2
0.01
0.30 **
0.33
2130 +
0.78 ***
18.9 ***
1.3 +
353 +
0.04
0.13 **
0.72 ***
0.66 ***
iiiiiKi
>\\\\i(\p, ISIiiiniliiifiH!1!,!" III! illl
K niiiu • liii IK 11
J 7= Thiodicarb M= Methomyl (A)= acute (C)= chronic
2 *** exceeds acute high, acute restricted and acute endangered species LOGs
** exceeds acute restricted and acute endangered species LOCs
-*• exceeds chronic risk LOG
iiiiiiniii'.ia'iiiiill'il!. liiiiirJiiii'iiiiiiiin' '''w>!<.ii!iiiiniiii|iii:iii|i|:,;lniiii;l
42- Risk Quotients For Aquatic Animals From Soybean Use
Species
Freshwater fish
Freshwater
invertebrate
Marine fish
Marine invertebrate
compound1
T(A)
M(A)
T(C)
M(C)
T(A)
M(A)
T(C)
M(C)
T(A)
M(A)
T(A)
M(A)
EEC (ppm)
0.009
0.041
0.005
0.037'
0.009
0.041
0.007
0.040
0.009
0.04J
0.009
0.041
Toxicity
1.47
0.5
0.036
0.057
0.027
0.008
0.0135
0.0004
0.53
1.16
0.029
0.23
RQ2
0.01
0.08 *
0.14
0.65
0.33 **
5.13 ***
0.52
100 +
0.02
0.04
0.31 **
0.18 **
IIK 11III1H
T=* Thiodicarb M= Methomyl (A)= acute (C)= chronic
? *** exceeds acute high, acute restricted and acute endangered species LOG:;
** exceeds acute restricted and acute endangered species LOCs
* , ; • ex.ggeji5.,the endangered species LOG
i^WlJi'/f*l*i!t!^S?*'t'Wi*,tiSC||l';^f^.ilMM1iE:'!Iiiffir!i " ;1 i"1""™ '!l: :""i;: •
I^M^MMMMy t! la i i i i i i i ' ' i' i aafifiif
'*i&W^flM^#I^H'Mft**::iW4|§jJ!*l
F^WIfi't^^I^ra II til
,iifeSil'W^^^^^^^I^''^K^:JtsB a>!
-I,' yii'iiifJiii;!™!!"!!;;1!1!1"!! aiiii'iii1'!!!":"!, hiiii'i'"-^*™'!/.'!!:; •' «s "WWP v :•. ,6'f,,» i;;1',, it'Ti, >«• \«« \ :»i r, ;ji MX:< ^, n1 ,,ii> 'S»\«'/ «»i; • \ KM: ji/iliiLiiiiiiiiiiiiiiiiiiiiiniiniiiiiiiib JiliSiiiiiliiSiLjiiiiiiS11
.1! liillinilililiillillllliiirnilll,,,, livilrril 'Illiiiiirlnl illllli'liir IIiiil!:!'";,. II
I '! 'l/'ll'IHillBI mil, llrMI
iiMiiniiiiiiivL: jiiii::iiirK:4iiiw:;i*iiiii«
ilCKI! nl'Kllhj, lllllllHL'iP1 /'
1 P'liililii "inJ IIV'i Ili'lfiiiU'llllllll!';" ,,
" ,i • i::i »•!'.' if,'::»^ ;i|"iii' "a11""" im nn ,,m',; ,:i. m
1,: mi,i,:111 mi ' I'll1 "ii '"i ruiH1,!!"11:11!1!!'"!' IF: i.«r' "intjii'flr l<:ln,l>li v jniiiii"'! ILH mni
-------
Table 43 - Risk Quotients For Aquatic Animals From Leafy Vegetable Use
Species
Freshwater fish
Freshwater
invertebrate
Marine fish
Marine invertebrate
compound1
T(A)
,M(A)
T(C)
M(C)
T(A)
M(A)
T(C) ,
M(C)
T(A)
M(A)
T(A)
M(A)
EEC (ppm)
0.005
6.024
0.003
0.023
0.005
0.024 '
0.004
0.023
0.005
0.024
0.005
0.024
Toxicity
1.47
0.5
0.036
0.057
0.027
0.008
0.0135
0.0004
0.53
1.16
0.029
0.23
RQ2
0.00
0.048
0.083
0.40
0.19 **
3.0 ***
0.30
57.5 +
0.01
0.02
0.17 **
0.10 **
1 T= Thiodica^b M= Methomyl (A)= acute (C)= chronic
2 *** exceeds acute high, acute restricted and acute endangered species LOCs
** . exceeds acute restricted and acute endangered species LOCs
+ exceeds chronic risk LOG
Acute toxicity studies show that thiodicarb is moderately to highly toxic to
freshwater and estuarine/marine fish, respectively, and very highly toxic to freshwater and.
estuarine/marine invertebrates. The degradate methomyl is moderately to highly toxic to
freshwater fish andmoderately toxic to estuarine fish. In a chronic early life-stage study,
methomyl significantly reduced fish larvae survival under flow through conditions.
Toxicity data suggest that aquatic invertebrates are much more sensitive to methomyl
contamination than either fresh or salt water fish species. While thiodicarb itself appears
to pose a low-acute risk to freshwater or marine/estuarine fish, the degradate methomyl
does pose acute risk to freshwater and marine fish. Degradation of thiodicarb, into
methomyl may also pose a chronic risk to freshwater fish for maximum application rates
and repeated applications on cotton. Both thiodicarb and its degradate methomyl can
present high acute risk to freshwater and marine invertebrates. Chronic risk to aquatic
invertebrates may result from thiodicarb in corn and cotton uses and from methomyl in all
uses. , '
Chronic risk to marine fish and marine invertebrates for thiodicarb and chronic risk
to marine fish and invertebrates for methomyl could not be adequately assessed due to a
lack of toxicity data. ,
Direct Application to Water (citrus use")
79
-------
...... !l ..... MHiftai.MitIIi ...... I
scenarios are available to mode| e^gosure for use sites such as drainage
! ......... 'Since direct pesticide application to water can occur when these sites are
j ...... a,,,s,£e,SS!2 ..... H§!S§>, ^e method of direct application to water was used to estimate
e DeWitt Nompgram (1966), a direct application of thiodicarb or '
of5"! ,^,^^,,?!,^?1) ^0.046 ppm (in 6 feet of
,
C/toxicity in ppm) for the drainage system were calculated using these
as follows:
^I^r™^^^!!^™'.1!*!^'! Acute freshwater fish
I,:;:;;;; 53; ™?SSSS£S& Wodicarb (0.551 to 0.046/1.47)= 0.3 to 0.03
!:: :::;: : :;:=::i;:?;==:•=== Methomyl (0.551 to 0.046/0.5)= 1.1 to 0.09
^(.mwflii, ^jriiSii™ T-S™ wimi Acute freshwater invertebrates
' " ' ' " ' ' ' " -"--•--—-: (0.551 to 0.046/0.027)= 20.4 to 1,7
to b" 0467o."db8)== 68 9 to 5^75
M Acute estuarine fish
HE!'1!!!!! HflH!!1!:!!':1:1'1'',!'':
.551 to 0.046/1.16)= 0.5 to 0.04
'l,:;!'I'll'iBll'l!Ill'EIIIIEJiiilill -i"!:!'
' • :=~^^^^ :•*=•• '• '• == -="•"=:;' '^2==:: • Acute estuarine invertebrates
!=
^^ b~;046toT23)= 2.4
\.^^l^^^l liese.RQs indicate that freshwater and estuarine, invertebrates are at high risk in
:: :|-:||-^IMlp^and deeper water bodies receiving direct treatment with thiodicarb. The rapid
I =»»is«aiilbreakdown into methomyl can significantly increase risk to aquatic invertebrates. The
BM=|i^J3^..to freshwater and estuarine fish are lower than to thei invertebrates^ The RQs
;;.*•>, mp:n4iLjK9t?_2^ltiieir?;..^2 ?¥Sk risks to estuarine fish in shallow water from both parent and
^':Jlijis llldegradate, and high risks to freshwater fish frpm^the presence of the degradate. However,
'•™;™ijil£'llisss.,aisi)niy minimal risks to fish from both compounds hi deeper waterways.
!1!BH^^^^ !biii'Y^iV^^^^^^^ ii!i!«^^^ S T-i j T-.- i ^ IVT j , T..
ijsHirsr-rssrf.;s:, sssiM '=— =~"'5a Exposure and Risk to Nontarget Plants
I * '111:!!!: a. '" ' Terrestrial and Semi-aquatic
No toxicity data are available (or required) to assess risk.
•iiniiiirfi mi 1 i inn i in i n iiii nil n i in i n M n i in' n i i |' ' ^ ' IM i|i 11 r in in in in i i
- i b. Aquatic Plants
Hill I'll I Ill IK 111 I
to nontarget aquatic plants may occur through runoff or spray drift from
adjacent treated sites or directly from such uses as drainage systems. An aquatic plant risk
assessment for acute risk for non-endangered species is usually done for aquatic vascular
.....
!1 ';| ..... p" I'liu
.
^^^ ..... IJiliBCIlIK^^^^^^^^^ ........ ! ...... ?il!tllE Jri-a'a'ii!1!1' ....... litlfiiiT'Klil^ilvl^i/lX^^^ ..... ,!• ..... tl ...... • ........ 1 ..... t
>HJ|^IW^^^^^^^^^^ ..... £ lin1!1 w ..... !W' '»i J1 "W'i ..... t ..... '!,: " !| ..... .11 *! ..... ir1 011 .<|i 11 AIR ...... ILl Wi'illr ih
iM^
-------
plants on the surrogate duckweed Lemna gibba. Non-vascular aquatic plant risk
assessments for acute High risk are performed on either algae or a diatom, whichever is the
most sensitive species. An aquatic plant acute risk assessment for endangered species is
usually done for aquatic vascular plants using the surrogate duckweed, Lemna gibba. To
date there are no known non-vascular plant species on the endangered species list. Runoff
and drift exposure is Computed from GENEEC. The risk quotient is determined by
dividing the pesticide's initial or peak concentration in water by the plant EC50 value.
Although not currently required, the registrant has submitted toxicity data for non-
vascular aquatic plants. Acute risk quotients for thiodicarb for non-vascular plants based
upon green alga (K. subcapitatd) toxicity are tabulated below.
' '/ .
Table 44 - Acute Risk Quotients for Aquatic Plants based EC50 of >8.3 ppm.
Site/ Application Method/ Rate of
Application in Ibs ai/A (No. of Apps.)
Com/aerial 0.75(10)
Cole crop/aerial 1.0 (6)
Cotton/aerial 0.9 (6)
Soybeans/aerial 0.75 (4)
Species
green alga
green alga
green alga
green alga
EC50 (ppm)
>8.3
>8.3
>8.3
>8.3
EEC (ppm)
0.058
0.065
0.036
0.022
RQ(EEC/EC50)
0.01
0.01
0.00
0.00
The results indicate that plant acute high risk and endangered species levels of.
concern are not exceeded for non-vascular single-celled aquatic plants at registered
maximum use rates. There are no data available (or required) to assess risk from
methomyl. , .
4. Exposure and Risk to Endangered Species
Endangered species LOCs are exceeded for most terrestrial and aquatic
(freshwater and marine) species and uses of thiodicarb and its degradate methomyl.
The Endangered Species Protection Program is expected to become final in the
future. Limitations hi the use of thiodicarb may be required to protect endangered and
threatened species, but these limitations have not been defined and may be formulation
specific. EPA anticipates that a consultation with the Fish and Wildlife Service may 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.
81
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contamination is greatest with highly permeable soils, shallow depths to ground water, and
an excess of water (from precipitation and/or irrigation) moving through the soil to carry
the chemical with it. While it may reach ground water under certain conditions, methomyl
may not persist under many conditions. . •
*•
Surface Water Assessment:
/ " .-..-•'
Thiodicarb may reach surface waters by drift during spray application. Both
thiodicarb and methomyl may run off to surface waters for a few days to several weeks
after application. Neither chemical is likely to persist in clear, shallow waters or in waters
with substantial microbiological populations. However, methomyl may persist hi waters
where sunlight penetration is limited (such as in deeper waters or waters with a significant
sediment load or populations of organisms such as algae). Neither chemical is expected to
persist in anaerobic sediments.
Runoff vulnerability of thiodicarb and methomyl is likely to be greater in high
rainfall areas (eastern and southeastern U.S.) than in semi-arid to arid areas (in large areas
of the southwest and western U.S.). Other sources of runoff include irrigation and
drainage ditches/ channels/ lines and lateral subsurface flow. In addition to site
characteristics, factors such as timing of pesticide application with rainfall and irrigation,
water management practices, foliar interception, crop management practices, and
formulation will also affect the potential for methomyl to reach surface or ground waters.
Characterization of Risk to Non-Target Organisms:
Because thiodicarb degrades relatively rapidly into the more persistent, mobile, and
toxic methomyl, the greater risk is posed by the degradate rather than the parent. The use
pattern (cotton, corn, soybeans, vegetables, cole crops and other minor uses) suggests that
numerous non-target birds, mammals, and beneficial insects that directly utilize these crops
for nesting, feeding, cover, and other activities are likely to be exposed to thiodicarb and
methomyl. In addition, indirect exposure from drift and runoff is likely to contaminate a
wide variety of ecosystems and possibly adversely affect non-target organisms utilizing
these habitats. ,
Terrestrial Risk Assessment:
Laboratory studies show that thiodicarb is practically non-toxic to birds but
moderately to highly toxic to small mammals on an acute oral basis. Methomyl is highly
toxic toxic to birds and mammals on an acute oral basis but only slightly toxic to birds on
a subacute dietary-basis. Thiodicarb may result in chronic isks to certain species that
frequent short grass (e.g, ducks, geese and swans); Methomyl, as a degradate, poses
acute risks to birds and mammals that feed on short and tall grasses, broadleaf plants, and
small insects. Methomyl also poses potential chronic risks to birds and mammals,
83
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The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the 'data identified hi
Appendix B. Although the Agency has found that all uses of thiodicarb, labeled and used
as specified in this Reregistration Eligibility Decision document, are eligible for
reregistration, 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 thiodicarb, if new information comes to the Agency's attention or if
the data requirements for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
.Based on the reviews of the generic data for the active ingredient
thiodicarb, the Agency has sufficient information on the health effects of thiodicarb
and on its potential for causing adverse effects in fish and wildlife and the
environment. The Agency has determined that thiodicarb products, labeled and .
used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks to humans or the environment Therefore, the Agency
concludes that products containing thiodicarb for all uses are eligible for
reregistration. . ,
2. Eligible and Ineligible Uses
The Agency has determined that all uses of thiodicarb labeled and used as
specified in this Reregistration Eligibility Decision document, are eligible for
reregistration.
Ci Regulatory Position
The following is a summary of the regulatory positions and rationales for
thiodicarb. Where label revisions are imposed, specific, language is set forth hi Section V.
of this document. It should be rioted that, because thiodicarb degrades rapidly to
methomyl in the environment, wherever relevant methomyl restrictions are more stringent
these will be applied to thiodicarb also.
1. Fojod Quality Protection Act Findings • \ .
Determination of Safety for U.S. Population
The Agency has determined that established tolerances with amendments and
changes as specified hi this document for thiodicarb meet the safety standards under the
85
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|ji'!i
I
n^^^ WFr
'
in iiiiiiH^ iiiiiiiiiiii iliki?'' iiiiiii :ii ,i«^ ii, ;4, i"' iii: ^ ,:/' H iiiwii i|!ii ?'w
ItiK^ iliiiiCILiV^^^^^^^^ '
FQPA amendments to section 408(b)(2)(D) for the general population. In reaching this
determination the Agency has considered the available' information on aggregate
exposures, both acute and chronic, from food and water as well as the possibility of
aggregate effects from tjgod|carb ^5 methomyl since mlodicarb decades rapidly to
methpmyj. | There are no residential or lawn uses of thiodicarb. ' •
, . §,MQ1 of 1P.QO is .required.
The .results, of tEe Monte Carlo acute iietajy exposure analyses, for ibiodicarb g^^
indicate that there are adequate margins of exposure for the general U.S. population
(MOE=2450).
For the acute aggregate dietary risk assessment for food, for thiodicarb and
methomyl combined, the endpoint for methomyl was used in the risk assessment and
compared to residues of methomyl from thiodicarb application plus residues of methomyl
fio,m methemyl application. A MOE of 300 is required. The results of the acute
aggregate exposure analyses for food, demonstrate that there are adequate margins of
; exposure for the general U.S. population (MOE=912).
i'iliUII1'' lllllIU,,,! llll'n.iil'llllllllll'illl'lll,, IlliiS'l.iill
The results of the chronic dietary risk evaluation system (DRES) analyses, for
--"-—••-—; --~"'::^iiodicarb alone, indicate that the anticipated residue contribution for the U.S. Population
S8%"6flhe FQPA adjured RfDl '
illi"iBIBIIi||'i I BIBiBBr! Blil'BBB!: II"T Bllll!!, , i, BIIIIBFI'BII11 „ i'MMM iP'JIi !i!' E:iil Ji|IIIIIBB!BIIIBIBIIIIIll' iJlB"1"1 B BIBIIIBB' B'i ilPlilPP'BlllPiillllMlj'Pii'ilP "'JimiJIPh IIPII :'LSf, I" Pllllli PT'illllllllllllll11 liPIPi.i1!"' ,!""li" < i iSa f, :'!,'. ii'™;!' B:BH iii iiiiii aim1 iiiihlil, 1* ftivt BIB, f 'iiiili 'iii ii! B: , ^a
~I J^^'CJ^^'-I^tenninaSon of Safety ..... for Infants and Children
! ' ,7i' ^ i! B":B,,: iiiiBBBiiiB B« ' ..B, rBBin '>> 'S ( >'B" '« W
ViPiBBBIBBBi Bliii-Bi'BBBIIi 'BiBllliBlllPllhilP-BII
ii i1 ipi i.iiniin iifliii iii|,, iiiiiniiiiiiiiii iiiiii!iii.i,!ii!||i< jin •|i|iiliiiiiiip ii in iiipinpinHiifl!' 'in
The Agency has determined that established tolerances with Jimendments and
?,,,d°c^^ safety standards under the
^S®JP) fo7infants and Children. In reaching this
~2^i^:::—"::: ."^r:"::,determination the Agency has considered the iavailable information on the ^gregate
!•!!! :isi! niiii ^'! aqiiio s:' i1;,: i *' '"'i i "• WIF »i Hipp' i 'Hi:1"jl1 iw u:::; I'liiiiiHii!: \»ii! fl^^^^ ': '„; v .1«!? ^IB ^ s MB: ' SuiitM iiii: i ^^^
,:!! !™V"'!''1T!, "!!""!","!"!!,!!'" l™:!™!'1™ ' "!!!:"':":'!'!!"„:!'," ! I!1'!!!™"!"" I^„T„™^"'I:,!'!,!!!!""'",!' !' i"!!!1"!!!!1"!1!""1":! T „„'!:: T"1!:!!"!"', OO ,
!to iiitiirW^^^^^^^^^^ !« •lllllli Iii, !JfW^^^^^^^^^^ ' Ii £iS^^^^ " 1» !!« '
liiffi
-------
exposures, both acute and chronic, from food and water as well as the possibility of
aggregate exposure from methomyl and tbiodicarb since thiodicarb degrades rapidly to
methomyl.
In determining whether to retain, reduce, or remove the lOx FQPA safety factor
for infants and children, EPA uses a weight of evidence approach taking into account the
completeness .and adequacy of the toxicity data base, the nature and severity of the effects
observed in pre- and post-natal studies, and information on exposure.
For purposes of assessing the pre- and post-natal toxicity of thiodicarb, EPA has
evaluated three developmental studies and one reproduction study. Based oil current
toxicological data requirements, the data base for thiodicarb, relative to pre- and post-
natal toxicity is complete. The data provided no indication of increased sensitivity of rats
or rabbits to in utero or postnatal exposure to thiodicarb. In the prenatal developmental
toxicity studies in rats and rabbits, effects in the fetuses were observed only at or above
treatment levels that resulted in evidence of maternal toxicity. In_the two-generation
reproduction toxieity study, although the effects in the offspring were observed at a
calculated lower dose (calculated NOEL =1.75 mg/kg/day) than in the parental animals
(NOEL =5 mg/kg/day), it was concluded that this is not a real indication of increased
susceptibility for the following reasons: 1) the endpoint (decrease in pup body weight) was
considered to be a systemic effect and not a developmental or reproductive effect since the
decrease was seen from day 7 through 21 of lactation in male pups and from day 14
through 21 hi female pups; 2) the decreased pup weight was seen only in one generation
(F2b) and not in the other generations thus lacking in consistency in response; 3) the data"
showed mat the body weight gain of pups in this litter was at a higher rate than the body
weight gain of control pups; 4) the decrease (8%) in both sexes on day 0 was not
statistically significant at day 4; 5) the lowest dose (5 mg/kg/day) is actually considered
close to a NOEL for the offspring while the 1.75 mg/kg/day was derived using Bench
Mark methodology; and 6) it is during the latter portion of lactation that pups consume
approximately twice the diet per unit body weight as an adult rat and, because of the
availability of the test material to the pups from both milk and the feed, the amount
consumed by the pups is likely more than double the adult's.
There are, however, data gaps for acute and subchronic neurotoxicity studies in
rats. These studies, are considered data gaps because thiodicarb breaks down to
methomyl, whiclxhas exhibited neurotoxic signs in two species (dogs and rabbits) by two
different routes of exposure (oral and dermal). In addition, thiodicarb produced
neurotoxic effects (tremors and inactivity in dams) in the rat developmental toxicity study
as well as tremors in rats in a 9-day inhalation toxicity study. The requirement for a
developmental neurotoxicity study in rats is in reserve status pending receipt of the acute
and subchronic neurotoxicity studies.
Based on these considerations, the lOx Safety Factor for increased susceptibility to
87
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Endocrine Disruption
' • • • -•* , p . ' •
The Agency 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 3 years from the passage of FQPA (August 3,1999) to implement
this program. At that time, the Agency may require further testing of this active ingredient
and end use products for endocrine disrupter effects.
Cumulative Risk
Although at present the Agency does not know how to apply the information hi its
files concerning common mechanism issues to most risk assessments, there are pesticides
for which the common mechanism issues can be resolved. These pesticides include
pesticides that are toxicologically dissimilar to existing chemical substances (in which case
the Agency can conclude 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 common mechanism of activity will be assumed). . .
The Agency does not have, at this time, available data to determine whether
thiodicarb 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 thiodicarb has a common mechanism of
toxicity with other substances.
2.
Tolerance Reassessment
Tolerances for residues of thiodicarb in or on food commodities are currently
expressed hi terms of thiodicarb and its metabolite methomyl [40. CFR §180.407 (a)]. As
a result of FQPA, pesticide residues are no longer regulated under section 409 of FFDCA.
Consequently, all'tolerances are placed hi 40 CFR section 180.407(a).
Tolerances Listed Under 40 CFR §180.407(0):
. Sufficient data are available to ascertain the adequacy of the established tolerances
on broccoli, cabbage, cauliflower, sweet corn (K+CWHR), cottonseed, cottonseed hulls,
leafy vegetables (except brassica vegetables), soybean hulls, and soybeans. The
cottonseed tolerance needs to be lowered from 0,4 ppm to 0.2 ppm.
New Tolerances Needed Under 40 CFR $180.407:
89
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Sufficient data are available to determine an appropriate tolerance for sweet corn
forage and foSder and ^ir^d_gr^iifiac^M i^m dusflt). The available com forage
data in3 storage stabilfty data support the 300 ppm tolerance that hiis been proposed by
the registrant This data will be translated to sweet corn fodder by using a forage-to-
fodderdry-down correction factor. On this basis, the tolerance for sweet corn fodder
shOiidbe sst.at.500.ppm. - - . '
, „ ..... • ..... w ....... , ....... , , ......
should
n/on aspirated grain fractions.
is required lor thio^carb residues ^oncotton.gm byproducts. An
tolerance will be determined once residue data are submitted.
' if^fyi^^'^:l^j^S'M{.\^:S^IKIffjgKlglt\<.!|||l!ll! il'i'1
:!!!!!!!!:!= :'«!!:!
CIIHII: li!H^
:
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correct Commodity
Definition
Tolerances listed under 40 CFR §180.407 (a):
Broccoli
Cabbage
Cauliflower
Corn, sweet grain
(K+CWHR)
Cottonseed
Cottonseed hulls
Leafy vegetables
Soybean, hulls
Soybeans
7.0
7.0
7.0
2.0
0.4
0.8
35.0
0.8
0.2
7-0
7.0
7.0
2
0.2
Revoke
35.0
0.4
0.2
Corn, sweet (K+CWHR)
Tolerance can bes lowered based upon
available data. Cottonseed, undelinted
Tolerance should be revoked as the
concentration (Llx) of residues in
cottonseed hulls is not significant.
Based upon a concentration factor of
3.6x and HAFT residues of 0.103 ppm,
the tolerance should be lowered.
Tolerances covered under 40 CFR §180.31
Com, forage
150.01
Revoke
Tolerances needed under 40 CFR §
Aspirated grain
fractions
None
3
Once a permanent tolerance of 300 ppm
is established under §180.407, the
temporary tolerance listed under §180.31
should be revoked.
180.407:
Tolerance required based upon data from
soybeans.
90
11
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Table 45 (continued).
Commodity
Corn, sweet, forage
(incl. cannery waste)
Corn, sweet, fodder
Cotton, gin byproducts
Current Tolerance
(ppm)
None
None
None
Tolerance
Reassessment (ppm)
300
500
TBD1
Comment/Correct Commodity
Definition
The available data support establishment
of a permanent tolerance of 300 ppm.
Permanent tolerance can be established
using a forage-to-fodder dry-down
correction factor
Residue data are required.
1. TBD = Jo be determined. Tolerance cannot be determined at this time because additional data are required.
Codex Harmonization '
The Codex Alimentarius Commission has established maximum residue limits
(MRLs) for thiodicarb residues in/on various plant and animal commodities (see Guide to
Codex Maximum Limits For Pesticide Residues, Part A. 1, 1995). Codex has combined
MRLs for thiodicarb and methomyl into a single listing. Although Codex MRLs and U.S.
tolerances are not presently compatible [the U.S. tolerance expression currently includes
only thiodiearb and its metabolite methomyl whereas the Codex MRL residue definition
includes thiodicarb, methomyl., and methomyl oxime (methyl hydroxythioacetimidate)],
EPA considers them to be essentially equivalent for enforcement purposes. While the
U.S. enforcement metihiod does measure the methomyl oxime, the Agency prefers not to
alter the U.S. tolerance expression to explicitly include the oxime metabolite since we have
previously indicated that the metabolite does not need to be regulatedl
A comparison of the Codex MRLs and the corresponding U.S. tolerances is
presented in the following table.
Table 46 - Codex MRLs for thiodicarb and applicable U.S. tolerances.
Codex
Commodity
(As Defined)
Cottonseed
Maize
Maize fodder
Maize forage2
Soya bean (dry)
Sweet corn
(corn-on-the-cob)
MRL1
(mg/kg)
0.5
0.05 (*)
50 fresh wt.
50 fresh wt.
0.2
2.0
Step
CXL
CXL
CXL
CXL
CXL
CXL
Reassessed U.S.
Tolerance (ppm)
0.2
None
None
300
0,2 .
2.0
*»
Recommendation and Comments
U.S. residue data indicate that a lower
tolerance is acceptable.
. Not registered for use in the U.S.
Not registered for use in the U.S.
U.S. residue data indicate that the higher
tolerance is required.
U.S. tolerance and Codex MRL are
compatible.
U.S. tolerance and Codex MRL are
compatible.
91
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111 '!
'i i t!::iii|i|iPi!i!i|i!ii|irii:!|iiiiP1
mmmrn «MS«^>IR 111 i «™^^^^^^^ B^W^S**.!!™ wi^i n^.-si :• M HfS'jtiiiftr^'i:asli&»i'«Hti^i!S m w>* ** •>:$ & >••:«' \ ." as • ; i i r i i -s :
•II II Illlllll Illi^^^ IIIIIIIIIIH^
II Illlllll I II II III 111
Codex
Commodity
(As Defined)
Tomato
MRL1
(rag/kg)
1.0
Step
CXL
Reassessed U.S.
Tolerance (ppm)
None
Recommendation and Comments
Not registered for this use in the U.S.
1. An asterisk (*) signifies that the MRL was established at or about the limit of detection.
2j CODEX does npt consider sweet corn forage to be a separate commodity.. This table compares the CODEX
MCL for maize forage to the U.S. tolerance for sweet corn forage.
In summary, if the Codex MRL residue definition for thiodiearb were amended,
U.S. tolerances and Codex MRLs for soybeans and sweet corn (K+CWHR) will be
, compatible.
' i!
Decisions
_T
Human Health
>II ......... ,IK':<;: ...... fuirztt ..... KI .F?HI.;.".KI:S.*
life;:'
' MRlHiiJ ' .v.s : =
* •• ' '•• ' •'"> ' • y ! "As determined in " ''
............. .• ....... •• .................. is- ........ - ....... • ................... '-""
_ .....
ion IV part C, section 1, the Agency concludes that
sources of residues pjPmetiipnryj from iModicarb application plus
of methomyl from methomy! application does not exceed Sie Agency's risk
1II1B •iniuiip Hi! linn ' <> ' ' , 11 ', in "ii ~ ". , I,,'',,' ;," ° J , „;,", ,
............ ;i
•
illlilllli lllillIM^ llFlillFI! li;.1! ,•'•
ie risfe of potential systemic toxiciry^ to mixers/loaders and other
l*!?!-*;ihandlers|he Agency is requiring the use of personal protective equipment and/or the use
controls (water soluble bags).
_ !iS^^^^^^^^^^^^^^^^^^^^^^^^^^^ ill^^^^^^^^^^^^^ ';:" :' !! 'S'S^, =!!!
::i:iiii?: =i^ I i" rai;iiii':iii^.^ivironmental Fate and Effects ' ' ' •
enrwronmentelj^ ...... studiesikishowt|iat ..... th|gdjcarJ2iL,dei^ades rapidly into
:irie'thomyl undei; most conditions. While the parent chemical does not appear to be very
" mobile, the degradate meihomyl is more persistesnt, more mobile, 'and
^^^ m :J«9.Fii, i
..... 1II111K
liE^^^^^^^^^^
igpgmy 1 has been detected in ground water in a prospective ground water
li^!mohitoring study and in other reported incidences, wl^g ft may j-gg^h grOund water
;:ss£r::1under certain conditions, methomyl will not Ukely persist under many conditions.
...... can ..... cpntamanate ..... surface ..... water _as_ajrajiltiof spray drift during application or by
Pyi would not be expected to persiijt in clear, shallow
becguse of itg, susceptibility to photolysis.
small mammals iid,,Miresutt,in
short grassv^.g, ducks, geese and
swans). Methomyl, the primary degradate of thiodicarb, is highly tadc to mammals and
linage 'iiiiiiiiiiii''' i~ 1:11: ':':• tin niiii' 1 'I'liiiii '(>!" liiiiiiiiii'!.! a,,,. II11111I i 'iiiwiTiii,, 'Hiii'Ai: iiiiLiiiDi,,' in:1 iihiiii > /"I KVi-TW'',^::''!:,;; 'istr -^^ ' , . ,
,ll,;fll:]||||||IK^ IBII'iFW 'ISlllib'H^^^^ IliaiMlB^^^^^^^^^^^^ Ilililllllll.!,'',,!, Ki 'Mii IliniSW lUi'l!ii',llll|ll',IK>:'i'K; li'H'll . IllltU
ll'llllHllll illlUI'U'i 1
•in
!:!::;!™
-------
poses acute and chronic risks to mammals that feed on short and tall grasses, broadleaf
plants, and small insects. In summary, tbiodicarb poses potential chronic risks to birds and
mammals, primarily due to the build-up of the degradate methomyl from multiple
applications of thiodicarb at short intervals.
Acute toxicity .studies show that thiodicarb is moderately to highly toxic to
freshwater and estuarine/marine fish, respectively, and very highly toxic to freshwater and
estuarine/marine invertebrates. The degradate methomyl is moderately to highly toxic to
freshwater fish and moderately toxic to estuarine fish. In a chronic early life-stage study,
methomyl significantly reduced fish larvae survival under flow through conditions.
Toxicity data suggest thataquatic invertebrates are much more sensitive to methomyl
contamination than either fresh or salt water fish species. While thiodicarb itself appears
to pose a low acute risk to freshwater or marine/estuarine fish, the degradate methomyl
does pose acute risk to freshwater and marine fish. Degradation of thiodicarb into
methomyl may also pose a chronic risk to freshwater fish for maximum application rates
and repeated applications on cotton. Both thiodicarb and its degradate methomyl can
present high acute risk to freshwater and marine invertebrates. Chronic risk to aquatic
invertebrates may result from thiodicarb in corn and cotton uses and from methomyl in all
uses. .
The major concerns for non-target organisms are the chronic risks posed by the
use of methomyl to non-target mammalian and freshwater invertebrate organisms. Risks
to aquatic invertebrates from exposure to methomyl are likely to occur wherever
methomyl is used. Accumulation of methomyl from repeated applications contributes to
the chronic risks.
4. Ecological Risk Mitigation for Thiodicarb
To lessen .ecological and potential water risks posed by thiodicarb and its
degradate methomyl, the Agency is requiring the following mitigation for thiodicarb
containing products. . -
1) The registrant will limit the maximum number of applications of thiodicarb on cole
crops to 4 per season at the maximum rate of 1.0 Ibs ai/A. Currently, the
maximum of 6.0 Ibs ai/A equals a total of 6 applications at the maximum rate per
season. The number of applications on cotton will be limited to 6 applications.
These measures will result in less loading of thiodicarb and its degradate methomyl
in the environment.
2) The following statement supporting the use of an Integrated Pest Management
(IPM) plan must be added to the labels.
"This product should be used as part of an Integrated Pest Management (IPM)
93
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in the Federal Register and have available voluntary county-specific bulletins. Because the
Agency is taking this approach for protecting endangered and threatened species, it is not
imposing label modifications at this time through the RED. Rather, any requirements for
product use modifications will occur in the future under the Endangered Species
Protection Program.
7. Labeling Rationale
At this time, all products containing thiodicarb are intended for occupational use
(e.g. mixed, loaded, and applied by commercial applicators only and'not available to •
homeowners). No registered use is likely to involve applications at residential sites.
The Worker Protection Standard (WPS)
The Agency has issued the Worker Protection Standard for Agricultural Pesticides
(WPS) affecting 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 (REI), and notification are interim.
These requirements are to be reviewed and revised, as appropriate, during reregistration
and other Agency review processes. •
At this time some of the registered uses of thiodicarb are within the scope of the
WPS and some uses are outside the WPS scope.
Requirements for Handlers
!- - ' •-•.' • -
For each end-use product^ personal protective equipment and engineering control
requirements for pesticide handlers ar^e set during reregistration 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 the risks to handlers posed by the
active ingredient are minimal, EPA may establish no a.i. specific handler
requirements. •
• Based on the acute toxicity characteristics of the end-use product, EPA usually
establishes handler PPE requirements for each end-use product.
. ' ^
• If a.i. specific requirements have been established, they must be compared to the
end-use-product-specific PPE and the more stringent choice for each type of PPE
(i.e., bodywear, hand protection, footwear, eyewear, etc.) must be placed on the
95
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epidemiological information, and post-application data.
EPA considered the exposure and cancer risk assessment for thiodicarb post-
application workers and the risks indicate an REI of at least 24 hours. However,
thiodicarb degrades to methomyl, and therefore, EPA has determined that the entry
restrictions should be based on exposures to methomyl. Estimates of methomyl
postapplication exposure and risk indicate that for certain crops, restricted-entry intervals
(REIs) based on the short and intermediate term dermal lexicological endpoint are
necessary. For crops and sites on which thiodicarb is registered, estimates of dermal
exposure and risk indicate that MOEs exceed 100 on the day following application (i.e.,
24 hours following application). However, since methomyl is in acute toxicity category 1
for primary eye irritation, at least a 48 hour REI is required.
For early entry into treated areas (i.e., during the REI) that is permitted under the
Worker Protection Standard and that involves contact with anything mat has been treated,
early-entry workers should wear the clothing and PPE consistent with the toxicity of the
active ingredient EPA has determined that the appropriate early-entry attire for dermal
protection to thiodicarb and methomyl, the major degradate of thiodicarb, is coveralls,
shoes and socks, and chemical-resistant gloves. In addition, protective eyewear must be
worn, since methomyl is classified as category I for eye irritation potential. EPA is
adopting this early-entry PPE for thiodicarb.
EPA is not requiring double notification for uses of thiodicarb.
Occupational-Use Products (NonWPS Uses^
At this time, EPA is #ot establishing entry restrictions of a specific length for
nonWPS occupational uses of thiodicarb end-use products, since .the anticipated
frequency, duration, and degree of exposure following nonWPS occupational applications
do not warrant special risk mitigation measures. However, EPA will prohibit entry into
treated areas until sprays have dried, such as rights-of-way, hedgerows, fencerows, and
drainage areas, due to concerns about inhalation exposures immediately after application
and as a prudent safety, practice. .
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 thiodicarb. For the specific labeling statements,
refer to Section V. of this document
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8* Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA Regional
97
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Offices and State Lead Agencies for pesticide regulation to develop the best spray drift
management practices. The Agency is now requiring interim meastires 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 hi spray drift
management practices to further reduce off-target drift and risks associated with this drift.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
1 i i 111 i •
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
i • , , , , f
The generic data base supporting the reregistration of thiodicarb for the
above eligible uses has been reviewed and determined to be substantially complete.
The following studies are required for thiodicarb.
81-8 Acute neurotoxicity study
82-7 Subchfonic neurotoxicity study
72-4(a) Estuarine/marine fish early life stage test
72-4(b) Estuarine/marine invertebrate life-cycle tests
164-1 Field Dissipation Study (cotton and corn)
860.1500 Magmtude of residue in cotton (|brrnerly 171 -4k)
; •:• -: : ; •. •..: :;;::;• : :» :»:::::, : -::- ::: 830.7050 UV/Visible absorption Spectrum.
i'||H^^^^
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h^il^^ a§i?g t*16 fisn earlylife stag*2 results and the risk mitigation required in this RED.
appSeS'to a vanejy'oTTeafy vegetables in the Monte Carlo .acute .dietary1 analysis is
11=";"'°JK wi|h Jhe Agency
jfrJl.tSe conduct of these stSe^mcluding tire appropriate cooking methods and
g^g gg weg gg |ge spggJgQ crops on which studies should b<} conducted.
JiH^^^^^^^ COO.
.tjonal, gesidueChem^try Requkements
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mm Jiilin. .iiiiiiiig ,
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to remove the restrictions against grazing of livestock in treated fields or the feeding of
treated corn silage or fodder to livestock. Label directions for sweet corn should also
specify a maximum use rate of 7.5 Ib ai/A for the entire season, rather than just after silk
initiation as is currently specified. Once label directions for sweet corn are amended, the
19 SLN labels for the use of thiodicarb on sweet corn can be canceled, because these uses
are essentially identical to the federal registrations.
Based upon the results of the confined rotational crop study, a plant-back interval
must be added to EUP labels. The registrant can choose to conduct limited field rotational
crop trials at the desired plant-back interval following soil treatment at Ix the maximum
registered rate (7.5 Ib ai/A) at two test sites. If residues of concern are detected in rotated
crops from the limited trials, extensive rotational crop field trials will be required to
determine the need for tolerances for thiodicarb residues in rotated crops. Alternatively,
the registrant can choose to revise their labels to impose a l-year restriction on the
planting of rotated crops not appearing on the label, and limited field trials and rotational
crop tolerances would not be required. If the registrant chooses to conduct the limited
field rotational trials, the labels must be changed in the interim to specify a 1 year
plantback interval.
2. Labeling Requirements for Manufacturing-Use Products and End-Use
Products
To remain in compliance with FIFRA, manufacturing use product (MUP) and end
use product (EUP) labeling must be revised to comply with all current EPA regulations,
PR Notices and applicable policies as noted in the following table.
99
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! nihP ,, mil ll'Ei'PII"'," IIP n:'>:' lllllliJli
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requirements regarding support of such use(s)."
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"This pesticide is toxic to fish, aquatic invertebrates, and mammals. Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries, oceans or other
waters unless in accordance with the requirements of a National Pollutant Discharge
Elimination System (NPDES) permit and the permitting authority has been notified in
writing prior to discharge. Do not discharge effluent containing this product to sewer
systems without previously notifying the local sewage treatment plant authority. For
guidance contact your State Water Board or Regional Office of the EPA."
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Any product whose labeling reasonably permits use in the production of an agricultural
plant on any farm, forest, nursery, or greenhouse must comply with the labeling
requirements of PR Notice 93-7, "Labeling Revisions Required by the Worker Protection
Standard (WPS)", .and PR Notice 93-11, "Supplemental Guidance for PR Notice 93-7",
which reflect the requirements of EPA.' s labeling regulations for worker protection
statements (40 CFR part 1 56, subpart K). These labeling revisions are necessary to
implement the Worker Protection Standard for Agricultural Pesticides (40 CFR part 170]
and must be completed in accordance with, and within the deadlines specified in, PR
Notices 93-7 and 93-1 1. Unless otherwise specifically directed in this RED, all statement
required by PR Notices 93-7 and 93-11 are to be on the product label exactly as instructel
in those notices.
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Mixers, loaders, others exposed to the concentrate, and cleaners/repah-ers of equipment
must wear:
~ coveralls over long-sleeve shirt and long pants,
— chemical-resistant gloves*,
-chemical-resistant footwear plus socks,
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In addition, applicators using handheld equipment must wear:
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*For the glove statement, use the statement established for thiodicarb through the
instructions in Supplement Three of PR Notice 93-7.
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areas. Do not contaminate water when disposing of equipment washwater or rinsate."
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are actively visiting the treatment area."
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as a result of label use. Use of this chemical hi areas where soils are permeable,
particularly where the water table is shallow, may result in ground-water contaminatioi
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it may also have a high potential for runoff into surface water for several days to weeks
after application. These include poorly draining or wet soils with readily visible slopes
toward adjacent surface waters, frequently flooded areas, areas overlaying extremely
shallow ground water, areas with in-field canals or ditches that drain to surface water,
areas not separated from adjacent surface waters with vegetated filter strips, and areas
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Avoiding spray drift at the application site is the responsibility of the applicator. The
interaction of many equipment-and-weather-related factors determine the potential for
spray drift. The applicator and the grower are responsible for considering all these factoi
when making decisions.
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The following drift management requirements must be followed to avoid off-target drift
movement from aerial applications to agricultural field crops. These requirements do no
apply to forestry applications, public health uses or to applications using dry formulation:
• P
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1. The distance of the outer most nozzles on the boom must not exceed 3/4 the length of
the wingspan or rotor.
2. Nozzles must always point backward parallel with the ah- stream and never be pointed
downwards more than 45 degrees. ' - .
Where states have more stringent regulations, they should be observed.
The applicator should be familiar with and take into account the information covered in
the Aerial Drift Reduction Advisory Information. •
INFORMATION ON DROPLET SIZE
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The most effective way to reduce drift potential is to apply large droplets. The best drift
management strategy is to apply the largest droplets that provide sufficient coverage and
control. Applying larger droplets reduces drift potential, but will not prevent drift if
applications are made improperly, or under unfavorable environmental conditions (see
Wind, Temperature and Humidity, and Temperature Inversions below).
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CONTROLLING DROPLET SIZE
• Volume - Use high flow rate nozzles to apply the highest practical spray volume.
Nozzles with higher rated flows produce larger droplets.
• Pressure - Do not exceed the nozzle manu&cturer's recommended pressures. For many
nozzle types lower pressure produces larger droplets. When higher flow rates are needed,
use higher flow rate nozzles instead of increasing pressure. • Number of nozzles - Use the
minimum number of nozzles that provide uniform coverage.
• Nozzle Orientation - Orienting nozzles so that the spray is released parallel to the
airstream produces larger droplets than other orientations and is the recommended
practice. Significant deflection from horizontal will reduce droplet size and increase drift
potential.
• Nozzle Type - Use a nozzle type that is designed for the intended application. With
most nozzle types, narrower spray angles produce larger droplets. Consider using low-drift
nozzles. Solid stream nozzles oriented straight back produce the largest droplets and the
lowest drift.
•
BOOM LENGTH
For some use patterns, reducing the effective boom length to less than 3/4 of the wingspan
or rotor length may further reduce drift without reducing swath width.
APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet above the top of the
largest plants unless a greater height is required for ah-craft safety. Making applications at
the lowest height that is safe reduces exposure of droplets to evaporation and wind.
SWATH ADJUSTMENT
When applications are made with a crosswind, the swath will be displaced downward.
Therefore, on the up and downwind edges of the .field, the applicator must compensate for
this displacement by adjusting the path of the aircraft upwind. Swath adjustment distance
should increase, with increasing drift potential (higher wind, smaller drops, etc.).
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•
WIND
Drift potential is lowest between wind speeds of 2-10 mph. However, many factors,
including droplet size and equipment type determine drift potential at any given speed.
Application should be avoided below 2 mph due to variable wind direction and high
inversion potential. NOTE: Local terrain can influence wind patterns. Every applicator
should be familiar with local wind patterns and how they affect spray drift.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up equipment to produce larger
droplets to compensate for evaporation. Droplet evaporation is most severe when
conditions are both hot and dry. '•'.'.
. '. •'•'*.'•
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 coyer 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.
•
i
SENSITIVE AREAS
The pesticide should only be applied when the potential for drift to adjacent sensitive areas
(e.g. residential areas, bodies of water, known habitat for threatened or endangered species,
non-target crops) is minimal (e.g. when wind is blowing away from the sensitive areas).
-------
VI.
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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 Thiodicarb covered by this Reregistration Eligibility Decision Document.
It contains generic data requirements that apply to Thiodicarb 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 GFR Part 15 8. the reference numbers accompanying each test refer to the test protocols
set in the Pesticide Assessment Guidelines, which are available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.
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 fopd
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
L -» . . - •
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer to the
Bibliography appendix for a complete citation of the study.
_ 133
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GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregistration Eligibility Document. Primary sources for studies hi this bibliography
have been the body of data submitted to EPA and its predecessor agencies in support of
past regulatory decisions. Selections from other sources including the published literature,
in those instances where they have been considered, are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case
of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single
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.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or "MRID number",. This number is unique to the citation,
and should be used whenever a specific reference is required. It is not related to the six-
digit "Accession Number" which has been used to identify volumes of submitted studies
(see paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. "This temporary identifying number is also
to be, used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a 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.
c.
d.
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.
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.
Trailing parentheses. For studies submitted to the Agency in the past, the trailing
143
-------
BIBLIOGRAPHY
MRID
CITATION
Drinking Water Regulations and Health Advisories. Office of Water. EPA.
Published in February, 1996.
Fletcher, J.S., J.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. Chem. 13:1383-1391.
Hoerger, F., 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 Tbieme Publ, Stuttgart, West Germany pp'
9-28. J>ff
Knisel, W.G., ed. 1980. CREAMS: A field-scale model for chemicals, runoff, and
erosion from agricultural management systems. USDA Conserv. Res. Rep. No 26).
Lyman, W. J., W.F. Reehl, and D.H. Rosenblatt. 1990. Handbook of Chemical ',
Property Estimation Methods/Chapter 5: Bioconcehtration Factor in Aquatic
organisms. American Chemical Society.
Lyman, W. J., W.F. .Reehl, and D.H. Rosenblatt. 1990. Handbook of Chemical
Property Estimation Methods. Chapter 15: Volatilization from Water; Chapter 16:
Volatilization from Soil. American Chemical Society.
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.
Pesticides in Ground Water Database: A Compilation of Monitoring Studies:
1971-1991 National,Summary .Published hi September 1992. EPA 734-12-92-001.
Wolfe, GW and Wentz, KL (1979). Final Report: Acute Oral Toxicity Study in
Male and Female Rats. Project No. 400-613. Unpublished study by Hazleton *
Laboratories America, Inc.. • .
DePass, LR; Woodside, MD; Weil, CS; et al. (1980). UC 51762. Chronic
Oncogenicity Feeding Study in Mice. Project No. 43-10. Unpublished study ny
. Carnegie-Mellon University Institute of Research.
Coate, WB; Keenan, DL; Dawkins, K.; et al. (1979). Final Report: Acute
Inhalation Toxicity Study in Rats. Project No. 400-615. Unpublished study by
Hazleton Laboratories America, Inc.
00025791
00041407
00041432
145
-------
mini mi'.ininiHinninni'i'iiiiiiiiiiPiiiri . am:, mm \ 4'<<; -"6". "« iff a WtK ; E; : na 'iiK
' v- n ' Jinf ssiLi Jiiiis:;! K , 1,1 H1'!!". i 'Din i* > i«:: i ...... i: jwn y in
in i jNgiiiiHiH'iii!1!'inn; ill" 'iiniiiii1, • :NI si; 1,1 •, i innnnnii'iiilnnnniiniiiii: n: • Hi»»<™ ™3; 00043740
DEj J^sb^EJ^Geil^RGj etal. 2979). Tendalogg Study^m^Rats. IRDCi
J ' International Research an3 i5evelopment
Corporation.
,,_ LR; Weil^CS^et al. {1979}. UC 51762: Rat Teratology
University
..... I
C^emcal Hv_gien_e Fej^wship. ''
DE; p^g'Jer™ fE; (5S3C RG; et al! JTOJ! KIcTPeratoiogy Study'in
I - Mice. IRDC No. 369-030. Unpublished study-by'International Research and
-sjBjsyelppment Corporation. ,
imiilllll'iiilnl ,111.1,1' :,nl II
llllll^
)43743
I ItJK
RodweU, DE; Janes, JM; Geil, RG; et al. (1979). Teratology Study in Mice. IRDC
" i i ' L , i i _ „ ' • • , , i i
Jo,, 362-031,. Unpublished study by International Research and Development
'"'CorporaSon.
H"! nil!!! I'lil'llllllllllllllllllllllli, llUnillllllll lilllllllill1 SPjIPilPPIIIlljlllllli IlliJilllllllll'lllliliiniPiillllllllinillllilllll1 rf, If" IIIIIIIIIIP'IIIHIPJIFT .igiVtHi,! IHimilN MUimn, IMIlim, miMIIIII l'i,,il<,illlillllVip, li:»)fll,ll IPll^llilliiPflBIPIIIilllll iPIIPlHPJnWPlBllPIIIIPIIPIIllllPi, .i". , ilP»ll»illllliii,|ll,llllllll»»"g li •» • "» " •: =»*! i - ~, ~,^^ ^ •.B:,, a: r • :, T::,:,,,I:M: i
Igupg, C.S.; Chancey, EX.; Hplsmg, G.C. (1977) Metabolism of UC 51762 in
2iIonP|^
264-341; submitted by Union Carbide Agricultural Products Co., Ambler, Pa.;
CDL:099600-F)
111 I III Illllllllill IN HIM I 111
p004406;9
Feung, C.S.; Chancey, EX.; Holsing, EX. (1977) Metaboliism of UC 4^656"in"'
Cotton Plant: File No. 23484. (Unpublished study received. Sep 10,1980 under
- . . '< •' i nil « '<»i • in '
go4-341; submitted by Union Carbide Agricultural Product!? Co., Ambler, Pa.;
;" • ' ~-::" 00044070
Feung, C.S.; Chancey, EX.; Holsing, G.C. (1977) Comparative Studies on the
S^Wti is SsKSJESfeazl^ SHSffis?,?, SfeMa^MI,5,-,
studryreceiveZ Sep'JrO~ 1980 uticTer'^-Sfl; siubmitted by Union
Carbide Agricultural Products Co., Ambler, Pa.; CDL:099600-H)
146
-------
BIBLIOGRAPHY
MRID
CITATION
00044071 Feung, C.S.; Chancey, EX.; Holsing, G.C. (1977) Comparative Studies on the
Metabolism of UC 51762 and Methomyl in Soybean Plant and Callus Tissue
Culture: File No. 24127. (Unpublished study received Sep 10,1980 under
264-341; submitted by Union Carbide Agricultural Products Co., Ambler, Pa.;
CDL:099600-I) _
00044072 Feung, C.S.; Chancey, EX.; Holsing, G.C. (1978) Absorption, Translocation, and
Metabolism of UC 51762 in Cotton Plants and Seeds: File No. 24948.
(Unpublished study received Sep 10,1980 under 264-341; submitted by Union
Carbide Agricultural Products Co.,Ambler, Pa.; CDL:099600-J)
00044073 Feung, C.S.; Chancey, EX.; Holsing, G.C. (1979) Disposition and Metabolism of
UC 51762 in the Senescent Soybean Foliage and Seeds: File No. 25817.
(Unpublished study received Sep 10,1980 under 264-341; submitted by Union
Carbide Agricultural Products Co., Ambler, Pa.; CDL:099600-K)
00044075 Khasawinah, A.M.; College, P.R.; Holsing, G.C. (1978) Fate of a Single Oral Dose
of I4C-Acetyl UC 51762 in a Lactating Cow-Metabolism into Natural Products:
File No. 25257. (Unpublished study received Sep 10,1980 under 264-341 ;
submitted by Union Carbide Agricultural Products Co., Ambler, Pa.;
CDL:099600-N)
00044269 Fink, R.; Beavers, J.B.; Grimes, J.; et al. (1978) Final Report: Acute Oral
LD50~Bobwhite Quail: Project No. 142-117. (Unpublished study received Sep
10,1980 under 264-341; prepared by Wildlife International, Ltd., submitted by
Union Carbide Agricultural Products Co., Ambler, Pa.; CDL:099603-B)
00044270 Fink, R.; Beavers, J.B.; Grimes, J.; et al. (1978) Final Report: Eight-Day Dietary
LC50~Mallard Duck: Project No. 142-116. (Unpublished study received Sep 10,
1980 under 264-341; prepared by Wildlife International, Ltd., submitted by Union
' Carbide Agricultural Products Co., Indianapolis, Ind.; CDL:099603-C)
00044271 Fink, R.; Beavers, J.B.; Grimes, J.; et al. (1978) Final Report: Eight-Day Dietary
' LC50-Bobwhite Quail: Project No. 142-115. (Unpublished study received Sep 10,
1980 under 264-341; prepared by Wildlife International, Ltd., submitted by Union
Carbide Agricultural Products Co., Ambler, Pa.; CDL:099693-D)
00044872 Jagannath, DR (1978). Mutagenicity Evaluation of CHF 41-43 in the Ames
Salmonella/Microsome Test (MNT). Study No. PH-309-UC001-79. Unpublished
study by Litton Bionetics, Inc.. ,
00044961 Arceo, RJ; Wilson, PD; and Myer, J. (1980). Acute Delayed Neurotoxicity Study
in Hens. Project No. IRDC 369-047. Unpublished study by International Research
147
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148
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Inc. '
44025502 Glaza, S.M. (1996). Primary Eye Irritation Study of Thiodicarb Technical in
Rabbits. Project No. CHW 50702038. Unpublished study by Corning Hazleton
Inc.. ,
44.025503 Glaza, S.M. (1996). Primary Dermal Irritation Study of Thiodicarb Technical in
Rabbits: Project No. CHW 50702037. Unpublished study by Corning Hazleton
. Inc..
_j •' \
44100701 Davis, C. (1996) Supplemental Submission of Freezer Storage Stability Data for
thiodicarb: Magnitude of Residues in Meat and Milk of Lactating Dairy Cows: Lab
Project Number: 1456: US94L01R: 45125. Unpublished study prepared by
Analytical Development Corp. 223 p.
44328701 Kidwell, J.; Barraj, L. (1997) Chronic and Dietary Exposure Assessment:
Combined Thiodicarb and Methomyl Residues: Lab Project Number:
TfflODICARB/METHOMYL 97-01. Unpublished study prepared by Novigen
Sciences, Inc. 79 p.
44328702 Kidwell, I; Barraj, L. (1997) Chronic and Acute Dietary Exposure Assessment:
Thiodicarb: Lab Project Number: THIODICARB 97-02. Unpublished study
prepared by Novigen Sciences, Inc. 125 p.
44343601 Kidwell, J. (1997) Chronic and Acute Dietary Exposure Assessment: Thiodicarb
and Methomyl Combined Residues: Supplemental Report: Lab Project Number:
METHOMYL/THIODICARB97-01-SUPPLEMENTAL REPORT. Unpublished
study prepared by Novigen Sciences, Inc. 38 p.
44343602 Kidwell, J. (1997) Chronic and Acute Dietary Exposure Assessment: Thiodicarb:
Supplemental Report: Lab Project Number: THIODICARB
97-02-SUPPLEMENTAL REPORT. Unpublished study prepared by Novigen
Sciences, Inc. 23 p.
44360702 Kidwell, J. (1997) Supplemental Report: Chronic and Acute Dietary Exposure
Assessment: Thiodicarb and Methomyl Combined Residues: Lab Project Number:
THIODICARB/METHOMYL 97-01 A-SUPPLEMENTAL REPORT.
Unpublished study prepared by Novigen Sciences, Inc. 52 p. .- ' .
44484101 Sousa, J. (1997) Thiodicarb Technical-Early Life-Stage Toxicity Test with
Fathead Minnow (Pimephales promelas): Final Report: Lab Project Number:
97-1-6867: 10566.0796.6404.120. Unpublished study prepared by Springborn
Laboratories, Inc. 85 p. (Relates to LOOOO176)
159
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
.ffiC22
CERTIFIED MAIL
Dear Sir or Madam:
' • " * ' •
This Notice requires you and otiier'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 product(s)
containing this active ingredient. Within .90 days after you receive mis Notice you must respond as
set forth -in Section III below. Your response must state:
1. How you will complywith 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 III-B); or
3. Why you believe EPA should not require your submission of data in the manner
specified by this Notice (see section III-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
produces) subject to this Notice will be subject to suspension. We have provided a list of all of
your products .subject to this Notice hi Attachment 2. All products are listed on both the generic
and product specific Data Gall-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), 7 U.S.C. section 136a(c)(2)(B). Collection of this
161
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n inn iii i in nil ii| infill i •iiiii|in 11 n nil I
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 3-31 -99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
Information and instructions applicable to all Data Call-in Notices. The Attachments contain
f'rrETiz ."£•"} "specific chemical information and instructions. The six sections of the Notice are:
(Ill IB1' pi'——5
Why You are Receiving this Notice
Data Required by this Notice
,111 - Compliance with Requirements of this Notice -
:""- "" - ' --Section FV; - Consequences of Failure to Comply with'this Notice •'
s' Obligation to Report Possible Unreasonable Adverse Effects
Inquiries and Responses to this f! ¥: ft ":ri!:Lii"ii V .'Hjjiii .inii'iii'1' 9 y ..... .;: n jfnf inn ..... i >' <\? 9\R ' tn, \'v itii11*!!!!11!1:; .t i»i iiir <: :
!,!! ,;j m«m\\«i va ..... >\\ \tt ....... Hiiniii
-------
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 hi 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 §
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 § 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 3(cY2)(B} NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in any way supersede or
change the requirements of anv previous Data Call-Ms! 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 then-
affected products.
SECTION HI.
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).
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
163 ~ •• -
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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.
Use Deletion -
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 arid 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 Formflnsert 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)j(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 not 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.
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
Exemption is item number 6a on the Data Call-In Response Formflnsert A). If you claim a generic
data exemption you are not required to complete the Requirements Status and Registrant's
165
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submitted as part of every response to this Notice. In addition, one copy of the Requirements
Status and Registrant's Response Formansert B^ also must be submitted for each product listed
on the Data Call-in Response Formflnsert A) 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 Formansert
A), indicating your election of this option. Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response Formsdnsert B). 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 are 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 III-C. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registranf's Response Formansert B) and item numbers 7a and 7b (agree to satisfy the product
specific date requirements for an MUP or EUP as applicable) on the product specific Data Call-In
Response Formflnsert 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.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and are
covered by option 7 of item 9 in the instructions for the Requirements Status and Registrant's
Response FormOnsert B). If you choose this option, you must submit the Data Call-In Response
Formansert A) and the Requirements Status and Registrant's Response Formrinsert B) as well as
any other mformation/data pertaining to the option chosen to address the data requirement Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
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III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
in i in i iiii
in i i i nil in
1. Generic Data
111 111! I 111 I Illllllllll III 111 ill III llllllllllllllllilllliillIM I 111 II III II
111 111 111
ll III 1
in* 1 in i iiiiiiiiiii i in nil i iiiiiii
If you acknowledge on the Generic Data Call-In Response Formflnsert A) that you agree
the generic date requiremente (i.e. you select item number 6b], then you must select one
..... '''''
[ated to 'oatapro35c"gon for eac£ g^ requirement Your option selection s£ou|5 ^"e enfered
Illllinn mi 111 nil 11 ill nil nun i nil iiiiiiniiinnnn nil n A\\ m . , A , — • • •, ' ^, n,
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
IS parentheses to guide you to additional instructions provided in this Section. The options are:
"_ _. _I will generate and gu^mt d^te >wthinjhe specified timefranie (Developing Data)
I Save entereS into an agreement with one or more registrants to develop data
to the
™ .
I" Save .niade offers to cost>share (Offers to Cost Share)
I amEmiffi an erasing s5idy^ tEat bias '
'"
I am submitting or citing data to upgrade a study classified by EPA as partially
Scceplable an9 upgradeable pjpgra(g1g a g^Jgy)
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
k°°se °
the required data it must be in conformance with Agency
guidelines and with other Agency requirements as referenced herein and in 1:he attachments. All
suErutteH'rrast
according to the Pesticide Assessment Guidelines (PAG) and be in
of PR Notice 86-5-. In addition, certain studies require^ Agency
of study initiation. Those studies for which a protocol must
as ^ Registrant's Response
!=^^ discussed in Section H-C
"^shto use a protocol which differs from the
you must .submit a detailed ^descriptipn of the
an your reason for wisnng to use it The Agency may
-------
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 Hie 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 Formflnsert 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 registrations).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional tune to meet the requirements^), 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 agreementto 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^greement 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 bindmg arbitration.-
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 been unsuccessful, you may
. 169
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' I .
inquest EPA (by selecting this option) to exercise its discretion not to suspend your
registration's), although you did not comply with the data submission requirements of this Notice.
EPA Sis Heteraim&Hnat as a gelaeraTpolicy, absent other relevant considerations, it will not
§uspend the registration of a product of a registrant who has in good faith sought and continues to
to enter into a joint data development/cost sharing program, but the other registrants)
the data has refused to accept the offer. To qualify for this option, you must submit
tEe^geicy ..... proving ..... mliFy7>u have ..... ^^ an o_g^r to g^t^ registrant (who has
:::ran obligation to submit data) to share in the burden of developing that data. You must also submit
ii=^^^ the Agency "'a^mpjete(j Certification with Respect to' Citations of Data (in PR Notice 98-5)
H (EPA Form 8570-34) . " In ..... g^gon, ...... yOU ..... m^t demonstrate that the other registrant to whom the
~ ]^er was ma4e"1Gas"not accepted your offer to enter into a cost-sharing agreement by including a
copy of your offer and proof of the other registrant's receipt of that offer (such as a certified mail
)1; ...... Your" ..... o^Fmus^ ..... m ...... ^jgftion ..... to ...... anymihg'elsej ..... offer to share in the Iburden of producing
W!:'lt!R'JhL u .
.............................................. Notice,
,9f^5..election of pi option to develop and submit the data required by this
aData ..... CJalPTn ..... Sesponse^ormTrnsartAli ...... and" ...... a ..... RJeiquirernente Status an!
committing to develop and submit me data required by this
In order for you to avoid suspension under this option, you may not withdraw your offer
•e in the burden of developing the data. In addition, the other registrant must fulfill its
i i « i iniiEi =.2 , - , - .; ,., , , ., 2, _ ,, :,, ,
- :::: ": :: :±: '-:'<£mmitmenHodeyel^^^ 3ata as Required by ffiis"HoHcei If the om» registrant fails
™™=^™:r!;™:J2 develop the data or for some other reason is subject to suspension, your registration as well as
rm^tof the other registrant| normally will be subject to initiation of suspension proceedings, unless
5J3 35 su&mi£'tEe reqliireH'daH uTtEe" specified" g^g ^^^ In'such cases,
-_™___ —_ submitting the datau
Option 4. Submitting an Existing Study
i "'.' ''" ! ' ' . '.' *
•"you choose to submit an existing study in response to this Notice,, you must determine
at mestudy satisfies the requirements imposed by this Notice. You may only submit a study that
submitted to the Agency or previously cited by anyone. Existing studies
rissuance 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 liat a study isnbfvaucl and needs to
i in iiiiiiiiiiiiiii i i • in 1111 n 11 mi i n in lisa, , — Si,, , , « , , , •, » i
...... fc
i "iniiij ...... hill wi: : t 'ii in i
...... ,'u II
..... :;;;ii;: siie yrniiiiiti :'!IIK ..... i <
I
^^ij^jo meej^ejreguiremente of the DCI Notice for subrnittin| an existing study, all of the
following three criteria must be clearly met
I ii!ili.i»^^^ SIM f
I i!' IiyillH^ IlllinW^ Hiai.Ell'ii IlllllC./';)!1!!!! 1!
';»«l-l «H^^^^ ill ^^jflaiKtt'M!rS->'!!=f~™;-.-'-i™&^i~. •- „;« • > • •. ,: |
F11'lNlMia; i!1:: KJW^^ ~
-------
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 orig'inal
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 data' 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."
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.
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. ;
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.
c.
171
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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 FIFRA".
n • H 1 | I
"I i, T
bption 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit data
nnkiM ,;
-------
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 Formrinsert 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
Fonn(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 Formrinserf B). These six options are listed
immediately below with information in parentheses to guide registrants to additional instructions
provided in this Section. The options are: ,
(1) I will generate and submit data within the specified time-frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has riot 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 stady mat 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 III.C. i, Option 1) except that normally no
protocols or progress reports are required.
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 III.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. , ' • \
Option 3. Offer to Share in the Cost of Data Development -The same requirements for generic
data (Section III.C.L, Option 3) apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above.
173
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i mlTliililliiwIii Jililiiiijliiiiili ilu^^ uiillli i :'l w11 illilii I i/ jir
i Jli!lli!«^
,...fli«^ . ,....
"Option 4. Submitting an Existing §ta3y — The same requirements described for generic data (see
^.C-L^Ogtion 4| apjply'to this option for pjoduct specific data. ,
•IB^^^^^^^ •
uag_a_§tudy. — The same requirements described for generic data (see Section
apply to 35s option for product specific 3ata.
„! , , » • ;. ....Option 6. Citing Existing 'Studies ~ The same requiremente described for generic data (see
Section III.C.1., Option 6) apply to this option for product specific data.
I JH Registrants who select one of the above 6 options must meet all of the requirements
lescriped in the instructions for completing the Data Call-In Response Formflnsert A) and the
Requirements Status and Registrant's Response Form(Insert B), and in the generic data
requirements section (HI.C.l.), as appropriate.
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Fllliii; Pliii'PPIl ,,.Nilllllllili" .llii'iUFI III Hi, '
There are two types of data waiver responses to this Notice. The first is a request for a
"'^low volume/minor use waiver and the second is a waiver request based on your belief that the
s) are not appropriate for your product.
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Dtion 8 under item 9 on the Requirements Status and Registrant's Response '
Form(Insert B). Section 3(c)(2)(A) of FIFRA requires EPA to consider the
appropriateness of requiring data for low volume/minor use pesticides. In implementing
,, ,,, , ™,. , ,, ,, ,
\icHoii vof^e foj: ^f pesticide registrants is small. In determining
grant a low volume, minor use waiver, the Agency will consider trie extent,
'aid volume of use, the economic incentive to conduct th^ testing, the importance
""
Tthe pesticide, and the exposure and risk from use of the pesticide,. If an active ingredient
I is used for bofE high volume and low volume uses, a low volume exemption will not be
1. If all uses of an active mgredient are low volume and the combined volumes for
' low, then an exemption may be granteS, Sependuig on review of other
^Jnfo^aation ojutijned^elow. An.iii!exemption will not be granted if any registrant of the
ingredient elects to conduct the testing. Any registrant receiving a low
p. sa|,|s,,,,figures in their forecast suggorting
registrant will b"e" requked^' as a condition of'the waiver, to submit annual sales reports.
";= ":!;::::iS^^^^^^^^^^^^^^^^^^^^^^^^ wjp I?sP9n^, to_ F.^qHests^ for waivers in VvTiting.
p«irwK?»M.'«S!HnTo apply for a low vomme/minor use waiver, you must submit the following information,
I :^ to y°3E P£oduc^s), ^as part of your 90-day response to this Notice:
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(i). Total company sales (pourids and dollars) of all registered produces)
containing the active ingredient. If 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 major 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 produces) 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 hot 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 produces)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of produces) 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
reasoning used to derive your estimates. To assist the Agency hi determining the degree of
importance of the active ingredient in terms of its benefits, you should provide information
on any of the following factors, as applicable to your product(s): (a) documentation of the
usefulness of the active ingredient in Integrated Pest Management, (b) description of the
beneficial 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
175
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iiii''
I !U|i|||i w i! Km i ij! j Ni1 ||!|||jj||| |'iiip; HI, ww A H1;«:« ^
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l^i^'«i^«Zl^^^d^zi"ite'persistence mthe environment, and (d) description of its iisefulness against a
:«^^
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for a waiver.
: :;; '"-. " :, ", :;::: i:::' ":::::; ' ::' ' b. ' Request for Waiver of Data
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;uloderlte'm^onme Requirements Status and Registrant's Response
orm. This option may be used if you: believe; that a particular date irequkement should not
'' '"" '" ' ' " " ' * ' - " " s" ' " " ~" is :
iiSPpJy,' Xou ^^ must submit lie current
i oFyour product(s5 and, if a current copy of your Confidential Statement of
t already on file you must submit a current copy.
WIHiiiiiiill! giGIVIiH
You will Be informed of the Agency's decision in writing. Ifthe Agency determines
!} ii (i pi i, j , * INIJ i™ P J s i 2 .2 „„ A ,
that the data requirements of this Notice are not appropriate to your product(s), you will
guired to supply the date pursuant to section 3(c)(2)(B). If EPA determines that
the date are requireS For your prcxfuctrsX you must choose a method of meeting the
iin^ iiiiiH
Agency's written decision, you must submit a revised Requirements
of your receipt i
:,,:;;, - - ;;: :~; ~; : «; Status anil Registrant's Response Form indicating the option chosen..
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s^a^^.f you request a waiver for product specific data because you believe it is
==• ...... ;^ j?or the requeS including technical
and references to relevant EPA rcgulatipns, gui(|efin££i or policies. (Note:
tol^^raj^^'s^mtl^m^e'&nnat required \yg_ !PR Notice 86-5). This
fliie ..... only opjaortunityto ..... stete"Sie reasons or provide information in support of your
£ |f the Agency approves your waiver request, you will not be required to supply
' ...... "1"
MiM^
Safa'pursuantto ...... sec5on"3^c7(35^51o"f HFRA. If the Agency denies your waiver
jgquest, you must choose an option for meeting the data requirements of this Notice
..... 1,Q ...... days of Se receipt of '3ie Agency's decision. You must indicate and submit the
^'["^"I'^Pption chosen on the product specific Requirements Stems and Registrant's Response
iFomflnsert BJ. Product sgecific date^requkemente for product cheimstry, acute toxicity
153 efficacy (^wbiere apjprogriate) are required for all products and the Agency^ would grant
[""'^yaiyer only under extraordinary circumstances. YOU sHoulcf also be aware that
submitting a waiver request will not automatically extend the due date for the study in
question. Waiver requests submitted without adequate supporting rationale will be denied
ff !T3:"JTf ."iJ^^^^SJbc orighial due date will remain in force.
-.- -. : SECTION IV.
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
I NOT!
'* i" ranmitm tra
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-------
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.
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 III-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 hi 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 Formdnsert A) and a Requirements Status and
Registrant's Response Formflnsert B).
b. Fulfill the commitment to develop and submit the data as required by this
Notice; or
c. Otherwise take appropriate steps to meet the requirements stated in this Notice,
unless you commit to submit and do submit me required data in the specified time
frame.
177
-------
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 VI.
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
(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 Formsflhsert A) need be submitted.
179
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Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
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:o this Notice are:
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Generic Data Call-in and Product Specific Data Call-in Response Forms with
Instructions
"(jSie'nc ..... DlJteTSalFTn ...... and^Prouct SeciHc
1 ssiiSSKiS i! ..... S; '- ~!:—~!S=SS:^ Registrant's Response Forms with Instructions
•"•~:~== J :•!•••!:• •^"•'I^L^IZ I EPA Batching of End-Use Products for Meeting Acute Toxicology Data
_ 1 M l«l A ,1
^:Er:i;=r.::::::r5 - List of Registrants Receiving This Notice
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THIODICARB DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
• You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Thiodicarb.
This Product Specific Data Call-In Chemical Status Sheet contains ah overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Thiodicarb. 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) EPA's Grouping of End-Use Products for Meeting
Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance Criteria (Attachment
5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost Share and Data
Compensation Forms in replying to this Thiodicarb Product Specific Data Call-In (Attachment 7).
Instructions and guidance accompany each form. -
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Thiodicarb are
contained in me Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on Thiodicarb 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 Thiodicarb 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 Bonnie Adler at (703) 308-8523.
All responses to this Notice for the Product Specific data requirements should be submitted
to: . • .
Bonnie Adler ••.... -
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: Thiodicarb
181
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i BUI aiiiiliiiiiiiii'i Jiii'iii'iiii'ii!1 niiniK niiii»iiiii;;| i:::::::::: ;,:::i::|j::; j1, ,„: ::::::;:::::::;i; j;,,,;*: ,,:,,::,,,:,,, ,:::;::::;:: :::£»:
™ ==^ ,
YpjyLhiX£.beensCT!tthis_Qsieri.c. Data Call-in Notice because you have product(s) containing
,'Tliiodicarb. ' ' ' ' ;"' ;":"": : ": :
This Generic Data Call-In Chemical Status Sheet contains an overview of data required by
::::; this notice, and' point of contact for uiquiries pertaining to the reregisfratiqn of Thiodicarb. This
Form (Attachment 2), (3) the Requirements Status and Registrant's Form
|, an3' |§) tEe" 'Cost f Eare and Date Condensation Forms in replying to this
ll.i,, iiilMnll'IOHFRlJll 'I'll'1*1: 'Illirfi iJii'l lllili f V «\ Oft I'll!!', ,i''P|| "|,| I'1 Wfl'lliii, |i' m'H'llll •lllll|llllti II
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l"lll!i|l!!il lll'll'-BlillHUHk1 'T,« IlLUP'Piil mmilllNil \""ff'' lll'ticei please contact'lorn Myers at
responses to this Notice for the generic date requirements should be submitted to:
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mmm ReregistrationBrancb.il
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protection Agency
Washington, D.C. 20460
'RE: Thiodicarb
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
INSERT A
Generic and Product Specific Data Call-in
Item 1.
Item 2.
V^
ItemS.
Item 4.
Item 5.
Item 6a.
ON BOTH FORMS: This item identifies your company name, number and
address;
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.
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 the period required
for submission of this response form. ,
ON BOTH FORMS: Check this item for each product registration you wish to •
cancel voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of that
request. Since this Data Call-In requires both generic and product specific data,
you must 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
(InsertB)
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
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 all your products, 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 that some of your sources are
185
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
INSERT B CONTINUED
. Generic and Product Specific Data Call-In .
ItemS.
Item 9.
Item 10. -
Item 11.
> Note:
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. ;
ON BOTH FORMS: Enter the date of signature. -
ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response. . •- .
ON BOTH FORMS: Enter the phone number of your company contact.
-Youmayprowdeaddifonalinfonnationthatdoesnotffiontoisf^^
youmaywisntoreporttnatyourprcxJucthasalreadybeentransfer^^
this product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct
187
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Instructions For Completing The "Requirements Status and Registrant's Response
Forms" (Insert B) For The Generic and Product Specific Data Call-In
INTRODUCTION
These instructions apply to Ihe 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 rndividually 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 tune 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.
193
-------
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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 of 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
'MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
195
-------
Ill . Ill Illllllll
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11 iiiini'i iiiiiiiii 1 iiiiiii nil hill111
TEP/PAI/M Typical End-Use Product or Pure Acitive Ingredient and
Metabolites
TGAI Technical (Jade Active Ingredient
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
.I, ,i i. ,, , „ ,,: ,..In|redient Radiplabejled
'«^^^^^^
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Imgurities
Dejradates
See:
fl:
I
Iteni 8.IIIZ,, .".i2Kitem^mplefed"bythe Aggncy identifies the time frame allowed for
submission of the study or protocol identified in item 5.
GENERIC DATA FXJKMt:' TJielime firame runs from the date of your
'
Ciiiili! lifWimi IMIll, IWl'MH^^^^ llilM^^^^^ II!' i||Jrofri ——— =—_-.— ———
i1!,1 ; , , , s ; , .:,. UIX LtitLi rKfJUUL/l i
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: Tne aue&fe for submission ,
of product specific studies begins from the date stamped on the letter transmitting
MiJllin^^ illillllH^^^^^^^^ S— s a B ij—i« n 5=.s •" i : = » = Y ^ •« » --
the Keregistration Eligibility Decision document, and not from the date of receipt.
S2SH *!!!!! :'!!l*:;!:«^^^^^^^^^^^^^^^^^ S5!2H EHowever! yourreroonse to tEe Data Caff-Tn iteeffis due 90 3ays from me"'date of
;L!il jiiinillllliiillhiil:1 NIKiiftdUr '^Hti^lBRHiliWMHfln^B^ B • •* ^ •« !• •• • •; "":"IL l»" ' • ' • ' I'"111' • "''' •' ""• * 1||f • " ""' IIL «*• ';|"" i • ' • ' ! • "
iii"! ; i vn :,,«« ; I>,IF i in ' i "»' '"li
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«-:;^.-- ™ ;: Item,9. ONBOTHFOKMS: Enterthe appropriate Response Code or Codes to show
::;:;::. ,.~,»..~...-—^Jaow. you, nitend to comply withi each data requirement. Brief descriptions of each
'!i\'^'!l?!i^!™?!^!8o^e fo"i|0-w" TEe" DateCain5'NoHce contains a SDer ge-s"Cj|^tiQ5 ^^eacgo£|ges~
HUMin '
.".* 'Options.
I '
-Option''''E ON goTH FORA^': ffievelopmg'Dafali'I will conduct a new study and
_^,.™™_^.™-_^_^v_^g^ ^ ^^ frames, specified in item 8 above. By indicating
I Jill^^^^^^^^^ I certify that I will comply with all the
fgqTtifements pertaining to the conditions for submiti:al of this study as
: outlined in the Data Call-In Notice and that I will provide the protocols and
!„ Bftfffie'progress1 reports required in item 5 above.
i iiiii iiriidi!iiiH» iiiiw^^ in
liijiiiiliK^^^^^ yption 2..
FORBIS: Sgre'emeliS'to Cost Shared I'have entered into an
to develop data jointly. By
mat I have chosen this option, I certify theit I will comply with all
to sharing in the cost of developing data as
I .......... IIUI ..... "I!
~™-".™r "• ==" .T™*ouflin^i' in the Data Call-In Notice.
'jiiiii'tiiiin nii«^ iiiii i!!i.i!i.|is!i:;ii!>:
...... Illlllllil ........ Illllllll
ii ; „ ; .; 1 Q/C
111 liliiilil:^ ii«^ ' i.:i ffiVIl;.!*]): .ii'lfiltil'M^^^^^^^^^^^^ l#l.i:...iJ|,Illlllll U: ' •"
atTIKlV^^^^^^^^ li«^^^^^ Hill
-------
However, for Product Specific Data, I understand that this option
is available for acute toxicityor 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 parry in
the agreementis committing to submit .or provide the required data; if the
required study is not submitted on tune, my product may be subject to
suspension.
N '','•"
Options. ON BOTH FORMS: (PJferJp_Cpjt^hare) 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
offer to another registrant (who has an obligation to submit data) to share
in the cost of that data. I am 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 Existing Data^ I will submit an
existing study by the specified due date that has never before been
1 • •• 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 I have
attached the needed supporting information along with this response.
Options. ON BOTH FORMS: (Upgrading a Studvl 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 me 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. ON BOTH FORMS: (Citing a Study) I am citing an existing study that
has been previously classified by EPA as acceptable, core, core minimum,
197
-------
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 DaFa^ 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
= jjp^i:.^^- : : ~~f~.= === Sjjft^Bj ;iS
^•••^encj,1 nas" '''• "
I_r~_.
Agency has grouped" with one or more other products for purposes of
..... (Eta! " rm'Hso'cwose IJSTopHbniFI ...... am "'citing my
MRID or ccession number (s).
ejlg ..... case, ......
erregistrant's'datai ...... I ..... 'will ...... ^n^'acompleteH ...... "Certification
With Respect To Data Compensation Requirements" form.
FOR TgjE GENjEMC DATA FORM ONLY; The following three options (Numbers
22 an3 9| are responses that apply only to the "Requirements: Status and
:'s Response Form" (Insert B) for generic data.
INI ii in nun ninny in inn ni
Option 7. (Deleting Uses) I am attaching an application for amendment to my
= =.'S^j==s= asssKfssfs.;:! rastsK;registration deleting the uses for which the data are I'equired.
i^y^^.:mt\ . Jtl^is" Option 8.
lliiin^^^^ IlllllllimilW^^^ liillltliij
(Low Volume/Minor Use Waiver Request) I have read the statements
; low volume-minor vise data waivers in the Data Call-in Notice
id I request a low-volume minor ^e waiver of the data requirement. I am
tacrung a 3etene^justulcation"to s-UppO"rt this waiver request iricMmg,
among other things, all information required to support the request. I
understand that, unless modified by the Agency in writing, the data
Sij^flir:;!^^^
.£ (Request for Waiver of Data) I have read the statements concerning data
r;;^=^= r,,—.;; =r™::^^:;:=;~ ;^;= 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
-::: -~ : , -:. ."~. ; :::: :::„ ::;,;:, .: ;,: ::: • • : i t = .:.:: , alSO |SUbjIUtting a COpy Of my CUirrat l^els. (YOU, ffilOSt alSO Submit 3. COpV_
Statemeirt of Fom^a^not^jady on file with EP^.
3ss mo2Jge3 gy m"e Agency in writing, the data
i stated1innime11No'trce governs.
lunderstani
FOR PRODUCT SPECIFIC DATA; The following option (number 7) is a response
that applies to the "Requirements Status and Registrant's Response Form" (insert
B) for product specific data.
* I Mb
I, Option 7. (Waiver Request) I request a waiver for this study because it is
i * I*™ •! ii'il'l'iii II* Illiiilllli »Mlhl^iiilftl|i inappropriate for my product. I am attaching a complete justification for
this request, including technical reasons, data and references to relevant
EPA regulations, guidelines or policies. [Note: any supplemental data must
•
[I fia^^^^^^^ IIIHIIC
Ii jkmiii 1% iiiiiiiiiiiiihi iiiiriH^^^^^
IJWiKHN^!
itljdill:11!1;!:;! iii^iil^iiyflSi^iiiiil^a ihli^fiilliEi'Jiiyiilja . if
I iliilililiiiiL "'I11'!" 11liRlilllilinii'vi: ii Ul.il 'Illlili' li'lllillllLi'iJ! Ul'limlH;. ;:;•: i:.m Elilhnli Jllll'in liJ1'!1' ii" lI'Jiil'iii'llllK II! 1 :|!"iliilii!Hli,'i snFjIlliiillHI!1'!Al illUllllllinilllll! |i|IIK !"< Hi* lillll'WIi:1' "illK'lir'iililliiiif||||lfill'"'!!!?'!!]!!"1! ill'i'l Ir'ilSfn'lllliilllll'illlP'Tllii II''
I @y»^
-------
Item 10.
Item 11.
Item 12.
be submitted in the format required by P.R. Notice 86-5]. I understand that
this is my only opportunity to state the reasons or provide information in
support of my request. If the Agency approves my waiver request, I will
not be required to supply the data pursuant to Section 3(c) (2) (B) of
FIFRA. If the Agency denies my waiver request, I must choose a method '
of meeting the data requirements of this Notice by the due date stated by
this Notice. In this case, I must, within 30 days-of my receipt of the
Agency's written decision, submit a revised "Requirements Status" form
specifying the option chosen. I also understand that the deadline for
submission of data as specified by the original Data Callrln notice will not
change. ,
-
ON BOTH FORMS: This item must be signed by an authorized representative of
your company. The person signing must include his/her title, and must initial and
date all other pages of this form.
ON BOTH FORMS: Enter the date of signature.
ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE: Y^rriaypro^deaddteonalirrfom^^
&tS^^
199
-------
r ji 11ill. i HIM
EPA'S BATCHING OF TfflODICARB PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
*• • ' " ' " ' ' ' ' " ' ' ' ' ' ' ,f ,'* '\ r'
In an efirt to reduce the time resources and number of animals needed to ifill the ....... acute
acgve
...... ..... ..... ...... ...... ......
loxicity data requirements for reregistration of products containing Thfodicarb
Sigredient, me Agency has batched products which can be considered similar for purposes of acute
tojgcity. Factors considered in the sorting process include each product's active and inert ingredients
................................. »ll:|ideatity, percent composition and biological activity), type of formulation (e.g., emulsifiable
:" ...... ' ......... '' ..... ffilpen trite" ............. aerosol! ............ wettaSfe" .......... jwnvder," ............ ^^— .............. — ^ ......... ^ labeling (e.g., . signal word, use
, etc.). Note that l£eA"geney rs"not"3eiciibing batched products
ii ...... -g— — — • prociucts within a batch may not be considered chemically similar
Pi have identical use patterns.
™S^IKiS2S!'.*lH'.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,,
If any Bme^ acKite"toxicity data for an individual product should the need arise.
IB!
, ., • ' "
may choose to cooperatively generate, submit or cite
of products within a bate]
^'Single battery of six acute toxicological studies to represent all me products within that batch. It is
'""* -"1Kerejj|!strants? o^oiTtoparErapite in m¥process with all other registrants, only some of the other
If a registrant chooses to generate the data for
a? batch, he/she must use one of me products within the batch as the test material. If a registrant
'"-"«isfeopses,to rely upon previously submitted acute toxicity data, he/she may do so provided thatthe
5 complete and valid by today's standards (see acceptance criteria attached), the
i cpnsideiedpy EPA to be similar for acute toxicity, and the formulation has not
id acceptance" oTiEe acute •
•."'/"whether new data is generated or existing data is referenced, registrants must clearly identify the test
EPA RegIsteation"1Nuniber!ffmorelhan one confidential statement of formula (CSF)
for a product, the registrant must indicate the formulation actually tested W identifying the
;CSF.
i i
In deciding how to meet the product specific data requirements, registrants must follow the
[^
IrespjDnsefonnswluchareto
If receipt The first fo"rm^ nD^a~C^IiirResponse^n asks whether the registrant will meet the data
L5|ifuirements 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.
" * : nt who wTsHes'to participate in a batch must decide whether he/she will provide the data.
"on s-o"m"e"o"ne g|s"g ""to 3o sol IFareglstranFsupp^fiTffie'daterto supporta batch of products,
:""or
• ' ' ' •• ""' he/shemust select one of the followjng options: Developing Data (Option 1)., Submitting an Existing'
l^iSuWKiUuli^ltucfy 7Qp||on 4"}, Upgrading an Existing gtu'^y ^Q-pgon ^ Qr ^.|s^g ^^ Existing study (Option 6).
Is^n^6^e?sd¥ta7h^he~m^ch"6^s^among: Cost" Sharing"(0ption 2), Offers
^ost Share (Option 3)* or Citing an Existing Study (Option 6). If a registrant does not want to
! in a batch, the choices are Options 1, 4, 5 or 6. However, a 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.
Eleven products were found which contain Thiodicarb as the active ingredient. These
products have been placed into two 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:
- Products in batch 1 may cite acute oral, acute dermal and acute inhalation data performed on EPA
Reg. No. 264-343.
- Products in batch 2 may cite category 3/4 acute oral, acute dermal and acute inhalation data
performed on EPA Reg. No. 264-343.
f • i* •
- EPA Reg. No. 264-341 may cite acute oral, acute dermal and acute inhalation data performed on
EPA Reg. No. 264-343. ,
- EPA Reg. No. 264-407 may cite category 3/4 acute oral, acute dermal and acute inhalation data
performed on EPA Reg. No. 264-343.
- EPA Reg. No. 264-411 may cite acute data performed on EPA Reg. No. 264-343.
- EPA Reg. No. 264-568 may cite category 3/4 acute data performed on EPA Reg. No. 264-343.
- EPA Reg. No. 65636-128 may cite category 3/4 acute data performed on EPA Reg. No. 264-343.
NOTE: The technical acute toxicity 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
!•
1
EPA Reg. No.
264-378
264-530
% Active Ingredient
••
80
80
Formulation Type
••Ml
Solid
Solid
EPA Reg. No.
264-379
264-406
9779-352
% Active Ingredient
34
34
34
Formulation Type
Liquid
Liquid
Liauid
201
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h nip n 111 HU
i i inn i n in
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/forms/.
nil ill ii inn niiiiiiiiini'lininn n nun iiiiini i nun i i niiiiiiiiiiiniiiiiniiiinninnin in n iiiiiiiiiiiinnnni
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1.
III I 111 111 11 ("111
(III I lllilllllTllllll
forms. (Note: Form numbers that are bolded can be filled out on.
your cSu-en"pnnte
1 .1 t n
The following Agency Pesticide Registration Forms are currently available via the internet:
a| the following locations:
iiPM^^^
i'llilHIll!'1
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an
Agreement with other Restraints for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5) ,
i«ImJm«a 8570-35 Data Matrix (in PR Notice 98-5)
http://www.epa.gov/opprd001/iorms/8570-l.pdf.
http://www.epa.gov/opprd001/ibrms/8570-4.pdf.
http://www.epa.gov/opprd001/ibrms/8570-5.pdf.
http://www.epa.gov/opprdOO l/ibrms/8570-17.pdf.
http://www.epa.gov/opprd001/ibrms/8570-25.pdf.
http://www.epa.gov/opprd001/fornis/8570-27.pdf.
http://www.epa.gov/opprd001/ibrms/8570-28.pdf.
http://www.epa.gov/opprd001/forms/8570-30.pdf.
http://www.epa.gov/opprd001/ibrms/8570-32.pdf.
http://www.epa.gov/opppmsdlyPR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdlyPR.JNbtices/pr98-5.pdf.
:::204 -, : ; ;
I illH^^^^^^^^^^^^ Kl»in^ ! I^KWW&3KKJtt MJmfW!>^.
-------
8570-36
8570-37
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
htto://www.eDa.Eov/orjDDmsdl/PR .Notices/or98-l .cdf.
http://viTvw.epa.gov/oDDDmsdl/PR Notices/or98-l.Ddf.
,
205
-------
Pesticide Registration Kit
.-I, -- - !•; Dear Registrant:
www.epa.gov/pesticides/registrationliit/.
'For your convenience, we have .assembled, an onUne registration kit which contains the following
™8
ion needed to register a pesticide product with the U.S. Environmental
.gang's''^Office of Pesticide ftogWis (OPP): ' ." _ " , '
HI, i 'iiiiiiiiiiiii1 mil uili piiiiiiipiiiii i iniiiiinii i, i IPIPHIIIII i q 11 nn \\\ it WPP IIPI 111111 in in iii IHIIIIIIIIIIIII h inniiiiiii i i"i I'liiii i ninn »i n i iiiiiinliiiiiPii iii 111 nil 11 iiii yi'i'i nil « « L ini i miii unpin m
j^i'Ssl,:; The Federal Insecticide2 Fungicide, ia^iRodei^cideiActi(FlFRA) atid the Federal Food, Drug
nniii i]'!'
:isw^
cide ...... egisttatibn 03 Notices
•Illllllll!llllllllllll!llll||llllllllilllllllllillllliiiiifc3« ............................. lililllllll ..... iiiinn ...... i ............................ uili ............................ fiiu, ............................ ,
iifc ii u iu, ............................ , . ........ < ............. * [[[ , .............................. ......... , .................................................. ....... < ............................ |i
;3 ....... Label ..... Improyement |Pro|gram--Storage and Disposal Statements
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation) ,
;, ' e. 87-6 Inert Ingrediente in Pesticjde^Pj-oducts Policy Statement
_ __, „„ ||.1^.jj1grej-ents m pestiqide Products; Revised Policy Statement
:= 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
s (Thisi document is
SSilSOther PR Nptices, can be ifound ^at ht1p:/^/www.epa.gov/opppmsdl/P]El Notices.
(These forms are hi PDF format and will
i ,Ei^;Eor|s,,,MQ. ...... M2fc34j Certification wj1hi Respect to Citatiions of Data
IIIIII "e. .......................................... HPAFomNo" ....... 8570-35^ 'j5^'M'a^ .................. ' .......................... ' .................................. | ' ^ ^ ^ ' ^
4. General Pesticide Information (Some of these forms are hi PDF format and will require the
'~~~~: ..... Acrobat jreader.) ' , ,. , . ' ' • . . ,"
; :;;;;;;:;;;;:;::; ...... ^^ ..... a. ............................................ Registration Division Personnel Contact List : j ................... ; [[[
.jjpljjlssil;^ .....
b, 53 F.R. 15952, Pesticide
cees; PecdepRegumente JDF
Labeling Requirements for Pesticides and Devices (PDF format)
I58a%£quirements for Registration '(PDF format)
|rr".^|riZ^ rif information.
F.R. 48833, Disclosure ofReviews of Pesticide Data |Ncvember27, 1985) \ ,
your application for registration, you may wish to consult some additional sources
•r't1 s * j
JLjtiese incluae:
:::L Ihe Offiee oI,Pesticide j
-------
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. TheNationalPesticideTelecommunications 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.
207
-------
Documents Associated with this RED
•ill i
i i
The following is a list of available documents that may further assist in responding to this Reregistration
Eligibility Decision document. These documents may be obtained by the following methods:
Electronic
Se1 Format: Portable Document Format (.PD'F)' requires Adobe® Acrobat or compatible reader.
Electronic copies are available on our website at www.epa. gov/REDs, or contact Tom
Myers at (703) 308-8589.
\ i i i '
PR Notice 86-5.
iii i * f 11 nil 111 in iiiiiiiii m in in i . i iiiiiiii i ill 1111 n 111
B. PR Notice 91-2
C, A full copy of this RED document
D. A copy of the fact sheet for Thiodlcarb
seet
documents are part of the AdmMsbative RecOTd^fo£Ms RED document and may
Qgfce Ofpe^gc^je programs public go^gj^ Copies of these documents are not
but may be pStaineS Ey contacting lie person listed" on tKe respective CEemical
' [[[ ' ................................ ' ....................... ...... ...... ' ............................................. ................. ' .............................................. ............................................
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v^mm g-^|||.. ^^- gnvjronmen|a*| g^c|s gcjence qg^p|ers> ' _
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