United States       Prevention, Pesticides    EPA738-R-96-014
        Environmental Protection   And Toxic Substances    August 1996
        Agency	(7508W)	
&EPA Reregistration
        Eligibility Decision (RED)

        Coumaphos

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                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
 V
 ^     "N~                            WASHINGTON, D.C. 20460
                                                                         OFFICE OF
                                                                   PREVENTION, PESTICIDES
                                                                    AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:

      I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case coumaphos
which includes the active ingredient, O,O-diethyl O-(3-chloro-4-methyl-2-oxo-2H-l-
benzopyran-7-yl) phosphorothioate. The enclosed Reregistration Eligibility Decision
(RED) contains the Agency's evaluation of the data base of these chemicals, its conclusions of
the potential human health and environmental risks of the current product uses, and its
decisions and conditions under which these uses and products will be eligible for
reregi strati on.  The RED includes the data and labeling requirements for products for
reregi strati on.  It may also include requirements for additional data (generic) on the active
ingredients to confirm the risk assessments.

      To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions  for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions.  You must follow all instructions and submit
complete and timely responses.  The first set of required responses are due 90 days from
receipt of this  letter. The second set of required responses are due 8 months from
receipt of this  letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.

      Please note that this RED was finalized and signed prior to August 3, 1996. On that
date, the Food Quality Protection Act of 1996 ("FQPA") became effective, amending portions
of both the pesticide law (FIFRA) and the food and drug law (FFDCA). This RED does not
address any issues raised by FQPA, and any tolerance-related statements in the RED did not
take into account any changes in tolerance assessment procedures required under FQPA. To
the extent that this RED indicates that a change in any tolerance is necessary, that
determination will be reassessed by the Agency under the standards set forth in FQPA before
a proposed tolerance is issued. To the extent that the RED does not indicate that a change in a
tolerance is necessary, that tolerance too will be reassessed in the future pursuant to the
requirements of FQPA.

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       If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregi strati on Division representative,
Edward Setren at (703) 308-8166. Address any questions on required generic data to the
Special Review and Reregi strati on Division representative, Dennis McNeilly at (703)
308-8066.

                                                     Sincerely yours,
                                                     Lois A. Rossi, Director
                                                     Special Review
                                                      and Reregi strati on Division
Enclosures

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             SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
             THE REREGISTRATION ELIGIBILITY DECISION (RED)

1  DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data.  If product specific data are
required, another DCI letter will be enclosed listing such requirements.  If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data.  Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90  days of the date
of this letter (RED issuance date); 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 data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification.  All waivers and time extensions must be
granted by EPA in order to go into effect.

3  APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-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 reregi strati on) separately. You  may
delete uses which the RED says are ineligible for reregi strati on.  For further labeling
guidance, refer to the labeling section of the EPA publication "General Information  on
Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).

      c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached  to the DCI)

      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
comply with P.R. Notice  91-2 by declaring the active ingredient as the nominal
concentration.  You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §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

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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 Data Compensation Requirements. Complete
and sign EPA form 8570-31 for each product.

4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.

5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

By U.S. Mail:

      Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      EPA, 401 M St. S.W.
      Washington, D.C. 20460-0001

By express:

      Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      Room 266A, Crystal Mall 2
      1921 Jefferson Davis Hwy.
      Arlington, VA 22202

6. EPA'S REVIEWS—EPA will screen all submissions for  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 reregi strati on determination within 14 months after the RED
has been issued.

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                 United States
                 Environmental Protection
                 Agency	
                      Prevention, Pesticides
                      And Toxic Substances
                      (7508W)	
EPA-738-F-96-014
August 1996
                 R.E.D.   FACTS
     Pesticide
Re registration
    Use Profile
    Regulatory
        History
                     Coumaphos
     All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered before November 1, 1984, be
reregistered to ensure that they meet today's more stringent standards.
     In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
     When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document
This fact sheet summarizes the information in the RED document for
reregistration case 0018, coumaphos.

     Coumaphos is an insecticide/acarieide used to control anthropod pests
on beef cattle, dairy cows, goats, horses, sheep, and swine. Formulations
include wettable powders, emulsifiable liquids, flowable, ready-to-use, and
dusts. Coumaphos is applied by aerosol can, dust bags, hand-held dusters,
dip vats, high and low pressure hand-held sprayers, backrubber oiler,
mechanical dusters, shaker can, and squeeze applicator.  The technical
registrant has stated they intend to voluntarily cancel the pour-on
formulation and prohibit application of dust formulations using mechanical
dusters, which are believed to result in higher applicator exposure.
     The U.S. Department of Agriculture (USD A) uses coumaphos in dip
vats, located principally along the U.S./Mexico border, to control ticks that
carry equine and bovine piroplasmosis (Texas Cattle Fever). Livestock,
almost exclusively cattle, are immersed in coumaphos solution by entering
and swimming through these large (4000 gallon) trench shaped vats.

     Coumaphos was first registered as a pesticide in the U.S. in 1958.
EPA issued a Registration Standard for Coumaphos in 1989 (PB90-
122243). In 1989 and 1992 Data Call-in's (DCI) were issued requiring
additional residue chemistry, environmental fate, and toxicological data.

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                         Currently, 26 coumaphos products are registered. Two of these
                    products are classified for restricted use due to acute oral toxicity, i.e., the
                    11.6% EC and the 42% flowable concentrate.  Coumaphos is used as a
                    direct animal treatment only; no food, feed, ornamental, or homeowner uses
                    are registered. The predominant use is  on beef and dairy cattle with much
                    smaller amounts being used on swine, goats, and horses. All uses of
                    coumaphos are considered to be outside the scope of the Worker Protection
                    Standard for Agricultural Pesticides (WPS).
                         The Agency currently is requiring additional handler
                    (mixer/loader/applicator) exposure data for coumaphos before it can make a
                    regulatory decision on non-USDA uses of coumaphos. Only the USD A
                    Animal and Plant Health Inspection Service (APHIS) uses of coumaphos
                    for control of ticks, where there is significant economic benefit and
                    employees are in a cholinesterase monitoring program, are considered
                    eligible for reregistration at this time. The Agency is deferring a regulatory
                    decision on all uses other than the USDA uses until handler (mixer/loader/
                    applicator) exposure data for coumaphos is submitted and reviewed.

Human Health   Toxicity
  Assessment        In studies using laboratory animals, coumaphos generally has been
                    shown to be of moderate to high acute toxicity. It is highly toxic by the oral
                    and inhalation routes of exposure (Toxicity Category I and n, respectively)
                    and moderately acutely toxic by the dermal route of exposure (Toxicity
                    Category UT). Technical coumaphos causes only mild eye and dermal
                    irritation (Toxicity Category in and IV,  respectively), and is nonsensitizing.
                    Coumaphos does not produce organophosphate-type delayed neurotoxicity,
                    based on acute neurotoxicity testing in hens.
                         Li vitro microbial studies for gene mutation and DNA damage
                    coumaphos did not cause a mutagenic response.  Coumaphos is classified
                    as a Group E carcinogen, indicating that it is non-carcinogenic to humans.
                    Studies utilizing rats and rabbits indicate that coumaphos does not cause
                    reproductive effects. Cholinesterase inhibition (plasma and erythrocyte) is
                    the primary target of coumaphos. Metabolism studies in rats indicate that
                    coumaphos is excreted (76-96%) in the urine and feces within seven days
                    of exposure.

                    Dietary Exposure
                         People may be exposed to residues of coumaphos through the diet.
                    Tolerances or maximum residue limits have been established for residues of
                    coumaphos in the meat, fat, and meat by-products of cattle, goats, hogs,
                    horses, poultry and sheep;  and in milk fat and eggs (40 CFR 180.189). The
                    registrant has voluntarily cancelled use  on poultry and therefore poultry
                    tolerances, including eggs, will be revoked as part of reregistration.

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     The Anticipated Residue Concentration (ARC) for the overall U.S.
population represents 39% of the Reference Dose (RfD), an amount
believed not to cause adverse effects if consumed daily over a 70-year
lifetime.  The most highly exposed subgroup, non-nursing infants - less
than one year old, has an ARC which represents 73% of the RfD. This
fraction of the allowable RfD is considered to be an acceptable dietary
exposure risk.
     The Agency also conducted an acute dietary exposure analysis
because coumaphos causes neurotoxic effects, i.e., cholinesterase
inhibition. Margins of exposure (MOEs), which show how closely
estimated exposure comes to a dose of concern, were calculated for the
overallU.S. population and several population subgroups including infants
(<1 year old) and children (1-6 years old). The Agency conducted this
analysis using high end or maximum anticipated residues, i.e., a
conservative approach very protective of human health. Infants (<1 year)
and children (1-6 years old) are the only subgroups whose exposure may be
of concern. However, these risk values represent an unrealistic worst case
situation. The Agency used many conservative assumptions in calculating
these risks, including:  1) the dose required to produce red blood cell
cholinesterase inhibition at three weeks, which would overestimate the dose
that would be expected to produce ChE from a single exposure; 2)
maximum residue levels present on all registered food items, with no
dilution or degradation of residues occurring during preparation or
processing of food; 3) all food items were treated with coumaphos. EPA
believes it is unlikely that infants and children will be exposed to
coumaphos-treated commodities at levels that will result in unacceptable
acute dietary risk.

Occupational and Residential Exposure
     The primary route of handler exposure to coumaphos is dermal.  The
Agency's primary concern is acute dermal exposure during mixing, loading, and
application of coumaphos, especially in the livestock dip-vat and handheld
sprayer uses where large amounts of coumaphos are handled. Livestock dip-vats
can hold up to 4000-4500 gallons and require the mixing/loading of up to 95 Ibs
of active ingredient (ai) to achieve the proper concentration when filling the dip
vats from empty. During hand-held sprayer treatment of cattle, up to 40.0 Ibs of
active ingredient may be handled, an amount sufficient to treat 1000 cattle at
maximum application rate of 4.0 Ibs ai/100 gallons.
     Chemical-specific exposure data for coumaphos were  never required to
support coumaphos registration or reregistration and are not available. EPA
assessed mixer/loader/applicator exposure and risk to coumaphos using the
toxicological endpoint dermal toxicity and surrogate exposure data in the
Pesticide Handlers Exposure Database (PHED), making assumptions that
coumaphos handlers wear certain personal protective equipment and that they

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treat a certain number of livestock, etc. Exposure estimates were conducted for
the two coumaphos use scenarios believed to result in the greatest exposure: dip-
vat use and handheld sprayers.
     MOB estimates for these two scenarios indicate a potential for unacceptable
handler exposure and/or risk from coumaphos as currently registered. The
Agency conducted exposure assessments for the dip vat and handheld sprayer
uses, making assumptions intended to reflect handling "typical" and "maximum"
amounts of coumaphos, i.e., pounds of active ingredient per day.  For example,
an exposure assessment must make assumptions concerning the number of
livestock that an individual will typically treat per day as well as a likely
maximum.  The Agency assumed a "typical" treatment of 100
cattle/day/individual and a "worst case" of 1,000 catiie/day/individual.  MOEs for
the handheld spraying scenario were 82 and 8.2, respectively assuming the lowest
registered application rate, while MOEs are eight times lower (10.1  & 1.1) at the
maximum application rate of 4.0 Ibs ai/100 gallons.
     MOEs for the dip-vat use were calculated to range from 9 to 36 assuming a
1000 or 250 gallon "topping off" or recharging of the dip vats after animals
moving through the vats have depleted the liquid level. Lower MOEs result
when the greater amount of active ingredient is handled, in this case sufficient
active ingredient to recharge 1000 gallons of dip vat solution.
     Uncertainties in the existing handler exposure databases (PHED) do not
allow the Agency to determine, with confidence, the exact MOEs for these
exposure scenarios.  However, the Agency finds that MOEs for large dip vat and
hand-held sprayer treatment of large herds are very low. Therefore, the Agency
is requiring closed systems for the mixing/loading of coumaphos products used in
dip vats and/or hand-held sprayers, i.e., water-soluble bags for the WP
formulation. The registrant must determine an appropriate system to reduce
handler exposure during mixing/loading for the flowable and emulsifiable
concentrate formulations.  The registrant may choose to reduce handler exposure
during mixing/loading with water soluble "gel packs", "no glug" containers, or
any other equivalent system approved by the Agency. The registrant must
propose a system within eight months and submit handler exposure studies within
one year to document handler exposure and confirm that improved
packaging/closed systems now results in acceptable MOEs.
     The Agency has made a regulatory decision concerning the USDA uses of
coumaphos because  of the very significant economic benefits and the fact that
USDA has a program in place to monitor the cholinesterase levels of title handlers
(mixer/loader/applicators) involved.  In the USDA program livestock are treated
with coumaphos to control ticks (Boophilus spp., Dermacentor nitems> and exotic
ticks) and prevent outbreaks of Texas Cattle Fever. USDA use of coumaphos
accounts for almost half of the U.S. usage.  USDA has estimated the economic
importance of this use to be between $1-5 billion dollars. The Agency has
decided, based on the economic importance of coumaphos to the  Texas Cattle
Fever Eradication Program, that all USDA uses  are considered eligible for

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reregistration, provided the required exposure studies are submitted and
mixer/loader exposure reduction measures discussed above are put into place.
When the chemical-specific exposure data required by this RED are received and
reviewed, the Agency will make a regulatory decision regarding the reregistration
eligibility of the non-USD A uses of coumaphos.
     The Agency believes that there is minimal potential exposure to persons
entering treated sites after application because most coumaphos is applied
directly to livestock. Post-application exposures do not appear to pose an
unreasonable risk to persons contacting treated animals, as long as contact is not
permitted immediately after application.

Human  Risk Assessment
     Based on the available toxicity studies, EPA has determined that
coumaphos presents a potential acute health hazard. It is of high acute toxicity
and is a cholinesterase inhibitor.  Coumaphos has been classified as non-
carcinogenic to humans.  Dietary exposure to coumaphos residues occurs from
meat and milk at very low levels. There are no  agricultural uses of coumaphos
registered, arid the dietary risk, both chronic and acute, appears to be acceptable.
     Of greater concern is the risk posed to coumaphos handlers, particularly
mixers/loaders/applicators, who are exposed during treatment of livestock.
Margins of Exposure (MOEs) are less than 100  (the margin believed to be
sufficiently protective) for applicators for several exposure scenarios. Exposure
and risk to workers will be mitigated by the use of PPE and closed systems, as
required by this RED.  Non-USD A uses of coumaphos are not eligible for
reregistration until mixer/loader exposure reduction measures are implemented,
and handier exposure studies are submitted and evaluated.
     EPA is employing a number of risk mitigation measures to protect
coumaphos handlers.  For example, the Agency is requiring "baseline" personal
protective equipment (PPE) and closed systems for the mixing/loading of
products used in  dip vats and/or hand-held sprayers, i.e., water soluble bags for
the WP formulation. The registrant must determine an appropriate system to
reduce handler exposure, e.g. water soluble "gel packs", "no glug" containers, or
any other equivalent system approved by EPA.  The Agency is requiring
exposure data to  be submitted, within one year after the RED was received, using
the proposed closed system.

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Environmental   Environmental Fate
   Assessment        The various degradation, metabolism, mobility, dissipation and
                    ground water studies, although found mostly to be supplemental, do
                    nevertheless support a qualitative characterization of the environmental fate
                    of coumaphos. • Coumaphos is persistent, with the exception that aqueous
                    photolysis is rapid with a half-life of 33 hours. The half-life is much greater
                    than 30 days for hydrolysis; much greater than a year for aerobic soil
                    metabolism; and ca. 118 to 185 days for field dissipation.  Coumaphos also
                    appears to be immobile, with Kd values ranging from 61 to 298 for parent
                    and from 91 to 161 for the degradate chlorferon.
                         The major coumaphos degradates identified under aerobic conditions
                    were chlorferon, which reached a maximum of 6,2% of the organosoluble
                    radioactivity recovered at six months, and 6-hydroxyl-3-methylbenzofuran,
                    the oxygen analog, which comprised a maximum of 0.2% of recovered
                    radioactivity at six months.  In column leaching studies, chlorferon and 6-
                    hydroxyl-3-methylbenzofuran comprised 3.1% and 0.2%, respectively, in
                    the top six inches of the sandy loam soil column. Similar results were
                    obtained using sand, silt loam, and silty-clay loam soil columns.
                         Coumaphos was applied to soil at 300 mg/l with and without
                    incorporation to evaluate leaching potential. The soil was not sampled at
                    sufficient depth to define the extent of leaching; however, samples taken 6
                    to 12 inches deep contained coumaphos at concentrations of 25 to 375 mg/I
                    32 weeks after treatment and at 5 to  69 mg/l 52 weeks after treatment. A
                    special retrospective field dissipation study was conducted to characterize
                    the depth of leaching in disposal pits and walkways of coumaphos
                    treatment dip vats. On-site disposal of spent coumaphos in unlined pits was
                    found to result in leaching of coumaphos, chlorferon and potasan to the
                    subsurface (72 inches in the study), and could result in ground water
                    contamination in areas of shallow ground water. These compounds may
                    reach ground water, although there was insufficient depth of soil sampling
                    conducted in the study to determine if coumaphos and/or its metabolites
                    could have reached the deep wells that were tested during the study.
                         Results of the special field dissipation study support the finding that
                    coumaphos is persistent; however coumaphos moved to greater depths than
                    expected based on it's Kd values. The apparently higher mobility in the
                    special dissipation study could have resulted from the high concentration of
                    spent coumaphos hi soil evaporation pits.
                         Several hundred thousand head of cattle are dipped every year in one
                    of the ca. 45 USDA vats mainly located along the U.S.-Mexican border.
                    The vats contain approximately 15,000 liters of coumaphos solution with
                    the active ingredient concentration of 0.15-0.31%. Vats are emptied,
                    cleaned, and recharged every 6 to 12 months, depending on usage,
                    generating approximately one million liters of coumaphos waste per year.

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Typically the vats are recharged when the sediment level reaches 10% of
the total volume.
     Since 1986 the Agricultural Research Service (ARS) of the USD A
has been conducting research concerning the degradation of coumaphos in
cattle-dipping vats.  Dip vat solutions of coumaphos can be inactivated
through the metabolic action of bacteria that are naturally present in some
dip vats.  The USDA/ARS has been experimenting with microbial
degradation of the spent vat solutions and has now successfully
demonstrated a detoxification procedure. This procedure has been tested in
laboratory scale equipment and most recently in the field in a full scale
(4,000 gallon tank) pilot test conducted in Texas.  Two spent vat solutions
were bioremediated to ca. 10 ppm. To date field testing of this
bioremediation method indicates that coumaphos levels in the spent vat
solutions are reduced from ca. 1200-1300 ppm to  10 ppm in a few weeks.
The spent solution would then be put into lined evaporation pits or applied
to non-agricultural land. Currently, the untreated 1200-1300 ppm spent
solution is deposited in unlined evaporation ponds.
     The Agency is requiring improvements in the disposal of coumaphos
spent dip-vat solution.  The Agency is requiring labeling that requires the
use of this bioremediation procedure and/or the use of lined pits for disposal
of spent solution that has not been bioremediated or ultimate disposal of
bioremediated solution. The Agency is allowing local and/or State
Environmental Control Agencies the option to permit use of lined
evaporation ponds.  The Agency believes that the lined  evaporation pond
method of disposal is much less desirable than bioremediation and should
be permitted only in those instances when use of the bioremediation method
is not feasible. If permitted by local regulations, the lined evaporation pond
can be eliminated and the bioremediated spent solution  (ca. 10 ppm
coumaphos) simply sprayed directly onto non-agricultural land in order for
further in-situ bioremediation to occur.  This decision should be made by
the individual states involved who are most familiar with the soil types and
ground water situation in their area. In any case, the Agency endorses this
method of treatment The Agency has concerns about leakage of spent dip
vat solution from lined evaporation ponds. Reducing the absolute amount
of active ingredient in the spent vat solution deposited in the evaporation
ponds greatly mitigates the Agency's concern with leakage.  This procedure
appears to be relatively inexpensive and initial communication with
USD A/APHIS, the dip vat operators, indicates that this treatment of vat
solutions is being pursued.
     The Agency considers the aerobic biodegradation of the spent dip vat
solution critical in preventing the downward and or lateral movement of
coumaphos and ultimately in preventing the contamination of groundwater.
Although it will result in increased cost, the use of bioremediation is
certainly much less  expensive than any "clean-up" of ground water that

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may be necessary if even one evaporation pond were to leak.  Because this
is new a procedure and will require capital upgrades (bioremediation tank
and/or lined pits) the Agency will phase in this disposal method revision
over a two year period from issuance of the RED. The Agency also
understands that technical assistance, e.g., answering questions concerning
construction of bioremediation tanks, will initially be provided by
USDA/ARS. The TJSDA/ARS will not operate bioremediation sites to treat
non-TJSDA spent dip vat solutions.

Ecological Effects
      Coumaphos is highly to very highly acutely toxic to birds if
consumed, based on terrestrial vertebrate test data.  Available
measurements of avian acute oral LDSO, for technical grade coumaphos
(TGAT), ranged from 2,4 to 29.8 mg/kg based on bobwhite quail, mallard
duck and pheasant. Available measurements of the avian dietary LC50,
using TGAJ coumaphos as the test material, ranged from 82.1 to 401.9
mg/kg based on tests including bobwhite quail, mallard duck,  ring-necked
pheasant and Japanese quail. For terrestrial mammals, a wide range of LDSO
values have been obtained based on testing using rats that indicate slight to
high toxicity on an acute oral basis: LDSO values were as low as 17 mg/kg
for the TGAI, and as low as 32 mg/kg for one end-use product.
  Data for aquatic organisms indicate that coumaphos is moderately to
highly toxic to fish on an acute basis: LC50 measurements for coumaphos
TGAI ranged from 0.34 mg/kg for bluegill sunfish to 5.9 mg/kg for rainbow
trout Coumaphos can be  characterized as very highly toxic to aquatic
invertebrates on an acute basis: LC50 values for coumaphos TGAI ranged
from 0.074 /^g/1 for Gammarus lacustris to 0,224 yu§j\. for Gammarus
fasciatus.
  Chronic toxicity data are available for aquatic animals. Data from a fish
early life stage study with coumaphos showed that for Rainbow trout, based
on the most sensitive parameters, length and weight, the NOEC, LOEC and
MATC are 11.7 /ug/1,24.6 ^g/l and 16.9 #g/l, respectively. Data from a
Daphnia magna life cycle chronic toxicity study with coumaphos showed
that based on the most sensitive parameter, survival, the NOEC, LOEC and
MATC are 33.7 ng/1,75.8  ng/1 and 50.5 ng/1, respectively. (The
concentrations here represent average measured values.)
      Data on marine and estuarine animals indicate that coumaphos is
highly toxic to marine and estuarine fish. The LCSO for sheepshead minnow
is 280 /zg/1. Coumaphos is also highly toxic to marine and estuarine
mollusks on an acute basis. The LC50 measurements for marine and
estuarine mollusks ranged from 290 //g/1 to 880 ftg/i based on the oyster
Crassostrea virginica.  Coumaphos is very highly toxic to marine
crustaceans on an acute basis. The available LC50 measurement was 2.0

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                     Ecological  Effects Risk Assessment
                          EPA is  concerned with the acute hazard of coumaphos to birds. Birds
                     could be exposed by ingestion of cattle hair, skin or debris or by secondary
                     exposure such as ingestion of other birds which consumed coumaphos
                     tainted materials. There is really no effective way to mitigate this risk short
                     of cancelling the use.  In view of the high economic benefits of this
                     insecticides use (est to be $1-5 billion by USD A) EPA believes that the
                     most appropriate means of dealing with this issue is a label advisory
                     indicating it's acute toxicity and potential exposure.
                       Technical coumaphos is moderately toxic to freshwater fish and very
                     highly toxic to aquatic invertebrates. There is a potential for exposure to
                     aquatic organisms resulting from washing-off of the material from the backs
                     of newly treated cattle that have entered a stream or pond.
                          While the potential for risk to aquatic invertebrates exists, it is
                     geographically limited to major cattle and dairy areas. EPA believes that
                     alerting cattlemen via label warnings is the most appropriate method to deal
                     with this concern.  In addition, the EPA does not expect sensitive, relatively
                     undisturbed aquatic ecosystems to be closely associated with feedlots where
                     the heaviest use  of coumaphos is expected to occur.

Ris k M iti 9 all on        To lessen concerns with the handler risks, ground water
                     contamination, and danger to avian species and aquatic organisms posed by
                     coumaphos use,  EPA is requiring the following risk mitigation measures:

                     °    Due to  concerns about the high acute toxicity of coumaphos, EPA is
                          establishing baseline personal protective equipment (PPE)
                          requirements for handlers of all end-use products.
                     o    To further  mitigate risks to handlers, EPA is requiring water soluble
                          packaging for powders and either water soluble "gel packs" or "no-
                          glug" containers (or other equivalent system approved by the Agency)
                          for flowable formulations.
                     o    To minimize post-application exposure, EPA is requiring a label
                          advisory to avoid contact with treated livestock until they are dry.
                     o    Disposal of spent vat solution in unlined evaporation pits is being
                          phasing out over a two year period. The new disposal method must
                          meet Local and/or State Environmental Control Agency requirements
                          for the  geographical area where the dip vat is located. The Agency is
                          recommending that spent dip-vat solution be bioremediated in
                          accordance with a method developed by the USDA/ARS. The treated
                          solution can then be transferred to lined, shallow evaporation ponds
                          or applied  to soil to encourage further degradation. Details can be
                          found in the coumaphos RED.

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    Additional Data
           Required
     The hazard to aquatic invertebrates and birds cannot be eliminated;
     however, it may be mitigated by label warnings.

The generic data base supporting the reregistration of coumaphos for the
above eligible uses, i.e. the USDA uses, has been reviewed and determined
to be substantially complete with the exception of occupational
(mixer/loader/applicator) exposure data. The following data are required
before, the Agency can make a regulatory decision regarding reregistration
eligibility of non-USD A uses of coumaphos:
                         Worker exposure
                         Guideline 23 l:Estimation of Dermal Exposure at Outdoor Sites
                              o
                              o
          Mixing/loading/application of dipping solutions for both the
          liquid and wettable formulations (The Agency will use these
          data to represent all mixing/loading operations, e.g., backrabber
          and dust bag setup).
          Mixing/loading/application of liquid and wettable powder
          formulations from high and low-pressure handwand sprayers.
          Application of ready-to-use, pour-on solutions.
          Application with shaker cans, foam spray cans, and application
          with mechanical dusters.
                         Guideline 232:Estimation of Inhalation Exposure at Outdoor Sites

                              o    Testing is required for the same uses as cited under Guideline
                                   231.

                         The following data are considered confirmatory:

                         Environmental Fate
                         Guideline 162-2: Anaerobic Soil Metabolism

                              The Agency also is requiring product-specific data including product
                         chemistry and acute toxicity studies, revised Confidential Statements of
                         Formula (CSFs), and revised labeling for reregistration.

  Product Labeling        All coumaphos end-use products must comply with EPA's current
Changes Required   pesticide product labeling requirements and with the following personal
                         protective equipment requirements as outlined below. For a comprehensive
                         list of labeling requirements, please see the coumaphos RED document
                                               10

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     EPA is establishing active-ingredient-based minimum (baseline)
engineering control requirements for liquid-concentrate and wettable-
powder formulations. EPA is also establishing active-ingredient-based
minimum (baseline) personal protective equipment requirements for all
handlers.

Ready-To-TJse Products: EPA is establishing minimum (baseline) PPE for
all ready-to-use formulations of coumaphos as follows:

     Applicators and other handlers must wear:
     — long-sleeve shirt and long pants,
     — chemical-resistant gloves, and
     — shoes plus socks,

Wettable Powder Products: EPA is requiring that wettable powder
formulation be contained in water-soluble packets. In addition, EPA is
establishing minimum (baseline) PPE for wettable powder formulations as
follows:

"Handlers exposed to the concentrate, such as during a spill or equipment
break-down, and all handlers participating in dip-vat applications must
wear:
— long-sleeve shirt and long pants,
— chemical-resistant gloves,
— chemical-resistant footwear plus socks,
— chemical-resistant apron, and
— face shield or goggles.

"All other handlers must wear:
~ long-sleeve shirt and long pants,
-- chemical-resistant gloves, and
— chemical-resistant footwear plus socks."

"Water-soluble packets when used correctly qualify as a closed loading
system. Handlers handling this product while it is enclosed in intact water-
soluble packets are permitted to wear long-sleeved shirt, long pants,
chemical-resistant gloves, shoes plus socks, and a chemical-resistant apron.
However, such handlers must be provided a face shield or goggles and have
such PPE immediately available for use in a emergency, such as a spill or
equipment break-down."
                       11

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 Regulatory
Conclusion
Emulsifiable Concentrate and Flowable Concentrate Products: EPA is
requiring that all liquid concentrate formulations be contained in "no-glug"
containers, water-soluble gel-packs, or other equivalent methods approved
by the Agency. In addition, EPA is establishing minimum (baseline) PPE
requirements for all liquid-concentrate formulations as follows:

"Mixers, loaders, and others exposed to the concentrate (such as during a
spill or equipment break-down) and all handlers participating in dip-vat
applications must wear:
— long-sleeve shirt and long pants,
— chemical-resistant gloves,
— chemical-resistant footwear plus socks,
— chemical-resistant apron, and
— face shield or goggles,

"All other handlers must wear:
— long-sleeve shirt and long pants,
— chemical-resistant gloves, and
— chemical-resistant footwear plus socks."

     The USDA use of coumaphos in accordance with approved labeling
will not pose unreasonable risks or adverse effects to humans or the
environment provided exposure reduction measures during mixing loading
are implemented as discussed above. Therefore, these uses of coumaphos
are eligible for reregistration. The EPA is requiring water soluble
packaging for powders and either water soluble "gel packs" or "no-glug"
containers (or other equivalent system approved by the Agency) for
flowable formulations.
     EPA does not have enough information at this time to make an
eligibility decision for non-TJSDA uses of coumaphos. The Agency is
requiring additional handler exposure data in order to develop a more
complete data base regarding these uses of coumaphos.
   For More
Information
     EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for coumaphos during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide Programs
(OPP), US EPA, Washington, DC 20460, telephone 703-305-5805.
     Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System

                      12

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at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
     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 coumaphos RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
     For more information about EPA's pesticide reregistration program,
the coumaphos RED, or reregistration of individual products containing
coumaphos, please contact the Special Review and Reregistration Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
     For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
                      13

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REREGISTRATION ELIGIBILITY DECISION

                COUMAPHOS


                   LIST A

                 CASE 0018
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
         SPECIAL REVIEW AND REREGISTRATION DIVISION

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                          TABLE OF CONTENTS



COUMAPHOS REREGISTRATION TEAM                                      i

EXECUTIVE SUMMARY                                                     v

I.     INTRODUCTION                                                       1

II.    CASE OVERVIEW                                                     2
      A.    Chemical Overview	2
      B.    Use Profile                                                       2
      C.    Estimated Usage of Pesticide  	10
      D.    Data Requirements	11
      E.    Regulatory History                                               11

III.   SCIENCE ASSESSMENT                                               11
      A.    Physical Chemistry Assessment                                    11
      B.    Human Health Assessment                                        12
            1.     Toxicology Assessment  	12
                  a.     Acute Toxicity	13
                  b.     Subchronic Toxicity                                  13
                  c.     Chronic toxicity                                      15
                  d.     Carcinogenicity Classification                          17
                  e.     Developmental Toxicity                               17
                  f.     Reproductive Toxicity                                18
                  g.     Mutagenicity                                        18
                  h.     Metabolism                                          19
                  i.     Endpoints Used for Risk Assessment                    19
                  j.     Reference Dose                                      20
            2.     Exposure Assessment                                       21
                  a.     Dietary Exposure                                    21
                  b.     Occupational and Residential                          23
            3.     Risk Assessment	26
                  a.     Dietary	26
                  b.     Occupational and Residential                          29
      C.    Environmental Assessment                                        34
            1.     Environmental Fate                                        34
                  a.     Environmental Chemistry, Fate and Transport          34
                  b.     Environmental Fate Assessment                        39
            2.     Ecological Effects                                          40
                  a.     Ecological Effects Data                                41
                        (1)   Terrestrial Data                                41

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                        (2)    Aquatic Data                                   43
                        (3)    Non-Target Insects Data                         46
                        (4)    Non-Target Plants Data                         46
                  b.     Ecological Effects Risk Assessment                      46

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION              55
      A.    Determination of Eligibility 	55
            1.     Eligibility Decision	55
            2.     Eligible and Ineligible Uses   	56
      B.    Regulatory Position	59
            1.     Tolerance Reassessment  	59
            2.     Summary of Risk Management Decisions	61
                  a.     Human Health 	61
                  b.     Environmental 	64
            3.     Restricted Use Classification	68
            4.     Reference Dose Exceedance  	68
            5.     Endangered Species Statement  	68
            6.     Labeling Rationale	69

V.    ACTIONS REQUIRED BY REGISTRANTS                               71
      A.    Manufacturing-Use Products                                       71
            1.     Additional Generic Data Requirements                        71
            2.     Labeling Requirements for Manufacturing-Use Products        73
      B.    End-Use Products                                                74
            1.     Additional Product-Specific Data Requirements                74
            2.     Labeling Requirements for End-Use Products                  74
      C.    Existing Stocks                                                   79

VI.   APPENDICES                                                         81
      APPENDIX  A.    Table of Use Patterns Subject to Reregistration           82
      APPENDIX  B.    Table of the Generic Data Requirements and Studies
                        Used to Make the Reregistration Decision	95
      APPENDIX  C.     Citations Considered to be Part of the Data Base
                        Supporting the Reregistration of Coumaphos	105
      APPENDIX  D.    Combined Generic and Product Specific Data Call-In    125
            Attachment  1.     Chemical Status Sheets  	145
            Attachment  2.     Combined Generic and Product Specific Data
                              Call-In Response Forms (Form A inserts) Plus
                              Instructions	147
            Attachment  3.     Generic and Product Specific Requirement
                              Status  and  Registrant's Response Forms
                              (Form B inserts) and Instructions	151
            Attachment  4.     EPA Batching of  End-Use Products for Meeting
                              Data Requirements for Reregistration            158

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      Attachment  5.     List of Registrants Sent this Data Call-In
                        Notice (Insert)	161
      Attachment  6.     Cost Share,  Data  Compensation  Forms,
                        Confidential Statement of Formula Form
                        and Instructions                               162
APPENDIX  E.    List of Available Related Documents                   169

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COUMAPHOS REREGISTRATION TEAM

Office of Pesticide Programs:

Biological and Economic Analysis Assessment
Doug Sutherland
John Faulkner
Steve Jarboe
Biological Analysis Branch
Economics Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Assessment
Harry Winnik
Richard Mahler
David Farrar

Health Effects Assessment

John Redden
William Greear
Bruce Kitchens
Christine Olinger

Registration Support

Linda Arrington
Mark Perry
Edward Setren

Risk Management Coordination
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Risk Characterization & Analysis Branch
Toxicology Branch I
Occupational and Residential Exposure Branch
Reregi strati on Support Chemistry Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Policy, Planning and Operations Branch
Dennis McNeilly
Reregi strati on Branch

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               11

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            GLOSSARY  OF TERMS AND ABBREVIATIONS

ADI           Acceptable Daily Intake. A now defunct term 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 (DWEL) The D WEL represents a medium specific (i.e. 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
FAO/WHO     Food and Agriculture Organization/World Health Organization
FDA           Food and Drug Administration
FIFRA         Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA        Federal Food, Drug, and Cosmetic Act
FOB           Functional  Observation Battery
GLC           Gas Liquid Chromatography
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
LC50           Median  Lethal Concentration.  A statistically derived concentration of a substance that can be
               expected to  cause death in 50% of test animals. It is usually expressed as the weight of substance
               per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50           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 i s
               expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo           Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL           Lowest Effect Level
LOG           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.
Hg/g           Micrograms Per Gram
mg/L           Milligrams Per Liter
MOE           Margin of Exposure
MP            Manufacturing-Use Product
MPI           Maximum Permissible Intake
MRID          Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A           Not Applicable
NOEC          No effect concentration
                                                 111

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            GLOSSARY OF TERMS AND ABBREVIATIONS

NPDES        National Pollutant Discharge Elimination System
NOEL          No Observed Effect Level
NOAEL        No Observed Adverse Effect Level
OP            Organophosphate
OPP           Office of Pesticide Programs
PADI          Provisional Acceptable Daily Intake
PAG           Pesticide Assessment Guideline
PAM          Pesticide Analytical Method
PHED          Pesticide Handler's Exposure Data
PHI            Preharvest Interval
ppb            Parts Per Billion
PPE           Personal Protective Equipment
ppm           Parts Per Million
PRN           Pesticide Registration Notice
Q*!            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 (c) of FIFRA)
TC            Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD            Toxic Dose. The dose at which a substance produces a toxic effect.
TEP           Typical End-Use Product
TGAI          Technical Grade Active Ingredient
TLC           Thin Layer Chromatography
TMRC         Theoretical Maximum Residue Contribution
torr            A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
ug/L           Micrograms per liter
WP            Wettable Powder
WPS           Worker Protection Standard
                                                IV

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EXECUTIVE SUMMARY

       This Reregi strati on Eligibility Decision (RED) document addresses the reregi strati on
eligibility of the insecticide coumaphos, i.e., O,O-diethyl O-(3-chloro-4-methyl-2-oxo-2H-l-
benzopyran-7-yl) phosphorothioate.

       Coumaphos is applied as a direct animal treatment to control arthropod pests of beef
cattle,  dairy cattle, goats, horses, sheep,  and swine.  Coumaphos is also used to treat swine
bedding. Coumaphos was previously registered for use on poultry but these uses do not appear
on any currently registered product.  Most coumaphos use is on beef cattle, with most of the
remaining use  on dairy  cows and  swine.  There are no registered uses  for coumaphos on
agricultural crops, ornamentals or in residences.

       Coumaphos is available in a variety of formulations for manufacturing use (90% technical,
25% dust base), for spot and wound treatment (1% dust,  5% dust, 3% spray, 3% foam), animal
spray and dip vat treatments (25% wettable powder, 11.6% emulsifiable liquid, 42% flowable),
back rubbers (5.8% and 11.6% emulsifiable liquids), back dusters (1% dust, 5% dust), bedding
treatment (1% dust) and as pour-on treatments (4%). Multiple applications to livestock and/or
livestock premises are permitted by current labels.

       Technical coumaphos is highly acutely toxic by the oral and inhalation routes of exposure
and is  moderately acutely toxic dermally.  Technical coumaphos can cause mild eye and/or
dermal irritation.  Coumaphos is not considered to be carcinogenic. Based on  animal studies
coumaphos does not produce organophosphate-type induced delayed neurotoxicity (OPIDN).

       The Agency has determined that coumaphos products, labeled and used as specified in
this Reregistration Eligibility Decision, may pose adverse effects to humans, i.e.,  low MOEs for
mixer/loader/applicators.  Uncertainties in the existing worker exposure databases do not allow
the Agency to determine,  with confidence, the appropriate MOEs for these exposure scenarios.
Therefore, the Agency defers making a regulatory decision except in those instances where a
regular cholinesterase monitoring program is in place. A  regulatory decision on the non-USDA
uses of coumaphos will be made when chemical-specific worker exposure studies are submitted
and reviewed.  The U.S.  Department of Agriculture  (USDA)  uses coumaphos  along the
U.S./Mexico border to control ticks that carry Equine and Bovine piroplasmosis (Texas Cattle
Fever). The Agency does believe that available data indicate an exposure problem exists and is
requiring improvements  to reduce handler exposure during the mixing/loading of coumaphos
products registered for dip vat and/or hand held spraying. The improvements consist of water
soluble packaging for powders and either gel packs or no-glug containers (or other equivalent
system approved by the  Agency) for the flowable formulations.  The Agency is leaving the
determination of the appropriate method to reduce handler exposure  for flowables during
mixing/loading to the registrant. However, that determination must be supported with appropriate
data indicating adequate  MOEs are achieved.  In the interim, the Agency is imposing a label
advisory for individuals to limit the number of animals they treat per day to no  more than 100
                                          v

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(assuming animals are treated at the maximum label rate, 200 if they are treated at 1/2 maximum
label rate, etc.).   It should be noted that the USDA has  a program in place to monitor the
cholinesterase levels of the workers involved in treating animals with coumaphos to prevent
outbreaks of Texas Cattle Fever, which is transmitted by ticks. The Agency is in consultation
with the USDA concerning possible strengthening of this existing program.  The Agency is
requiring the registrant to submit the worker exposure studies on an accelerated schedule, i.e., one
year from the issuance of this document. When chemical-specific exposure data required by this
RED are received and reviewed, the Agency will be in a position to make a regulatory decision
regarding the reregi strati on eligibility of the non-USDA uses of coumaphos.

       The Agency can make a regulatory decision concerning the USDA uses (Texas Cattle
Fever) of coumaphos because of the very high economic benefits. It is estimated, by USDA, that
the cattle industry would sustain annual losses of $1-5 billion dollars if cattle fever ticks and the
associated disease, babesiosis, were to become re-established in the U.S..  Equine babesiosis
could result in mortality  rates of about  10% or greater in susceptible horses.   There are no
available estimated economic  losses due  to the disease if introduced in the horse population in
the U.S.. It should be noted that international movement of show and race horses and cattle from
the United States would be severely restricted.

       Coumaphos  is essentially immobile  and persistent in soil and therefore there are no
immediate concerns for ground  water contamination from non-point  source  application of
coumaphos.   However,   coumaphos is apparently more mobile when  poured at  high
concentrations into disposal  pits (ca. 1300 ppm)  associated with the animal dip vat use.
Coumaphos could pose a threat to ground water quality  if spent coumaphos animal vat dip
solution were disposed of improperly. The current disposal practice is to dispose of the spent vat
solutions by pumping it to shallow, unlined evaporation ponds. When the water evaporates, the
dried sludge is removed from the pond and disposed of on land by plowing it under (on  non-
agricultural land) to encourage further degradation in the soil. The Agency is concerned that
evaporation ponds and/or associated liners could leak and is working with the U.S. Department
of Agriculture, Agricultural Research Service together with the technical registrant Bayer to
develop an improved disposal method.  In that on-going research effort, the USDA has conducted
pilot scale studies,  partially funded by  Bayer Animal  Health, to evaluate the potential for
bioremediation of the coumaphos spent  dip vat solutions. Laboratory and preliminary  field
studies indicate that coumaphos levels can be reliably reduced from 1300 ppm to ca. 10  ppm
using relatively simple technology practical for use in remote locations where many of these dip
vats are located. The Agency concludes that reducing the coumaphos levels by bioremediation
is preferable to lined evaporation ponds alone and will continue to pursue this method of waste
disposal with the USDA and the coumaphos technical registrant, Bayer. Disposal of spent vat
solution in unlined pits will no longer be  allowed.

       Technical coumaphos is highly to very highly toxic to birds. Birds may be exposed to
coumaphos by feeding in the vicinity of treated cattle,  or directly from the hides of treated cattle.
However, the limited use pattern, i.e., only used for direct livestock treatment, is expected to
                                          VI

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confine problems to areas around feedlots or other areas where treated cattle may congregate.
There is only one known avian incident during the thirty years that coumaphos has been
registered for use and the source of exposure in that incident is unknown.

      Technical coumaphos is moderately toxic to freshwater fish and very highly  toxic to
aquatic invertebrates. There is a potential exposure to aquatic organisms resulting from washing-
off of the material from the backs of newly treated cattle which have entered a stream or pond.
A hazard to aquatic invertebrates could also result from improper disposal of spent vat dipping
solutions.  The hazard to aquatic invertebrates cannot be eliminated, however, it may be mitigated
by label warnings.

      The USDA Tick Eradication Program restricts cattle access to water for seven days after
treatment with coumaphos. It should be noted that USDA use of coumaphos comprises almost
one-half of total coumaphos use in the U.S.. For the remainder of uses the Agency will address
the risks to aquatic organisms with a label advisory.

      Due to the acute toxicity of coumaphos, the lack of chemical specific exposure data for
all coumaphos uses, and the low MOEs calculated for mixer/loader/applicator the Agency is now
requiring  handler exposure data. The Agency has  previously required acute and subchronic
neurotoxicity testing, that requirement remains unchanged by this RED.  While the data base is
"substantially complete" for the purposes of making this reregi strati on decision, the Agency is
requiring this data as confirmatory for the USDA uses of coumaphos.  The handler exposure
studies are required before the Agency can make a regulatory decision regarding reregi strati on
eligibility of all other uses of coumaphos.  The Agency is also requiring additional environmental
fate data, i.e., an anaerobic aquatic metabolism study which is considered confirmatory for all
coumaphos uses.

      The  Agency is  requiring  "baseline"  personal  protective equipment  (PPE)  for
mixer/loader/applicators of  coumaphos due to its acute toxicity.  PPE  requirements vary
depending on the particular scenario, e.g., less PPE is required for closed system mixing/loading.
Details concerning the PPE requirement for coumaphos can be found in Section V of this RED.

      Before reregistering the products containing coumaphos, 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 the
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 reregi strati on only when the other active ingredients are determined to be eligible for
reregi strati on.
                                          vn

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I.      INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregi strati on of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregi strati on process to be completed in
nine years. There are five phases to the 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.

       This  document presents the Agency's decision  regarding the reregistration eligibility of
the registered uses of coumaphos.  The document consists of six sections. Section I is the
introduction. Section II describes coumaphos, its uses, data requirements and regulatory history.
Section III discusses the human health and environmental assessment based on the data available
to the Agency. Section IV presents the reregistration decision for coumaphos. Section V discusses
the reregistration requirements for coumaphos . Finally, Section VI is the Appendices which
support this Reregistration Eligibility Decision.  Additional details  concerning the Agency's
review of applicable data are available on request.

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II.    CASE OVERVIEW

      A.     Chemical Overview

             The following active  ingredient is covered by this Reregi strati on Eligibility
      Decision:

      •      Common Name:          Coumaphos

      •      Chemical Name:          O,O-diethyl    O-(3-chloro-4-methyl-2-oxo-2H-l-
                                      benzopyran-7-yl) phosphorothioate

      •      Chemical Family:         Organophosphate

      •      CAS Registry Number:    56-72-4

      •      OPP Chemical Code:      036501 (OPP - Office of Pesticide Programs)

      •      Empirical Formula:       C14H16C1O5PS

      •      Trade and Other Names:  Asuntol, Bay 21/199, Baymix, Co-Ral, Coumarin,
                                      ENT-17957, Meldane, Muscatox, Negashunt and
                                      Resitox

      •      Basic Manufacturer:      Bayer Corp.

      B.     Use Profile

             The following is information on the currently registered uses with an overview of
      use sites and application methods.  A detailed table of these use of coumaphos is in
      Appendix A.


             Type of Pesticide:  Insecticide/acaricide

             Use Sites:          Use on beef and dairy cattle; sheep;  goats; horses; swine
                               and swine bedding. Predominate use is on beef cattle.

             Target Pests:      Face fly, horn fly, fly larvae, cattle grubs, ticks (including
                               ear  tick),  lice,  mites,  screwworms,  sheep  ked  and
                               fleeceworms

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Formulation Types
Registered:        Technical Grade Active Ingredient:
                   Solid  90.0%
                   Manufacturing Product:
                   Dust  25.0%
                   End Use Products:
                   Dust  1.0 to 5.0%
                   Emulsifiable Concentrate 5.8 to 11.6%
                   Flowable  Concentrate 42.0%
                   Liquid-Ready to Use  4.0%
                   Pressurized Liquid  3.0%
                   Wettable Powder 25.0%

Method and Rates of Application:

      Equipment - Dip vats, low-pressure hand-wand, high-pressure hand-wand,
      backrubber oiler, handheld/mechanical dusters, dust bags, aerosols, ready-
      to-use pour-on devices.

      Method  and Rates  - Dusts,  sprays,  dips, pour-ons, dust bags,  and
      backrubber oils. Maximum use rates are specified in the following table.

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Table A.  Registered uses and maximum rates of application for coumaphos products.

INDOOR FOOD
 Dairy Animals
 DAIRY CATTLE (LACTATING OR UNSPECIFIED)

      Animal treatment (backrubber), when needed, backrubber
      11.6% emulsifiable concentrate; 1.0 Ib AI/13 gal oil
      5.8% emulsifiable concentrate; 0.5 Ib AI/13 gal oil

      Animal treatment (dust bag), when needed, dust bag
      5.0% dust; dose by product
      1.0% dust; 0.005 Ib Al/animal

      Animal treatment (dust), when needed, duster/hand held duster/mechanical
             duster/shaker can
      1.0% dust; 0.00125 Ib Al/animal

      Animal treatment (dust), when needed, squeeze applicator
      5.0% dust; dose by product

      Animal treatment (ear), when needed, aerosol can
      3.%  pressurized liquid; 5 sec/ear; dose by product

      Animal treatment (ear), when needed, squeeze applicator
      5.0% dust; dose by product

      Animal treatment (spray), when needed, sprayer
      26.3% wettable powder; 0.25 Ib AI/100 gal water
      11.6% emulsifiable concentrate; 0.25 Ib AI/100 gal water
       5.8% emulsifiable concentrate; 0.25 Ib AI/100 gal water

      Animal treatment (wound), when needed, aerosol can
      3.0% pressurized liquid; dose by product

      Animal treatment (wound), when needed, squeeze applicator
      5.0% dust; dose by product

 DAIRY CATTLE (NON-LACTATING)

      Animal treatment (spray), when needed, high pressure sprayer
      42.0% flowable concentrate; 2.1 Ib AI/100 gal water
      26.3% wettable powder; 4.0 Ib AI/100 gal of water

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     11.6% emulsifiable concentrate; 3.0 Ib AI/100 gal water
      5.8% emulsifiable concentrate; 2.0 Ib AI/100 gal water

     Animal treatment (spray), when needed, sprayer
     42.0% flowable concentrate; 2.1 Ib AI/100 gal water
     26.3% wettable powder; 1.0 Ib AI/100 gal water
     11.6% emulsifiable concentrate; 1.0 Ib AI/100 gal water
      5.8% emulsifiable concentrate; 1.0 Ib AI/100 gal water

     Dip treatment, when needed, Vat
     42.0% flowable concentrate; 2.55 Ib AI/100 gal water
     26.3% wettable powder; 2.5 Ib AI/100 gal water

     Pour-on, when needed, Not on label
     4.0% liquid RTU; 0.0015625 Ib AI/100 Ib animal weight

DAIRY GOATS (NON-LACTATING)

     Animal treatment (spray), when needed, sprayer
     26.3% wettable powder; 2.0 Ib AI/100 gal of water

     Animal treatment (wound), when needed, sprayer
     26.3% wettable powder; 2.0 Ib AI/100 gal of water

     Dip treatment, when needed, Vat
     26.3% wettable powder; 2.0 lb/100 gal of water

     Pour-on,when needed,Not on label
     4.0% liquid RTU; 0.0015625 Ib AI/100 Ib animal weight

Meat Animals Other Than Poultry
 BEEF (RANGE/FEEDER) CATTLE (MEAT)

     Animal treatment (backrubber), when needed, backrubber
     11.6% emulsifiable concentrate; 1.0 Ib AI/13 gal oil
      5.8% emulsifiable concentrate; 0.5 Ib AI/13 gal oil

     Animal treatment (dust), when needed, dust bag
     5.0% dust; dose by product
     1.0% dust; 0.005 Ib Al/animal

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Animal treatment (dust), when needed, duster/hand held duster/mechanical
duster/Shaker can
1.0% dust; 0.00125 Ib Al/animal

Animal treatment (dust), when needed, squeeze applicator
5.0% dust; dose by product

Animal treatment (ear), when needed, aerosol can
3.0% pressurized liquid; 5 sec/ear; dose by product

Animal treatment (ear), when needed, squeeze applicator
5.0% dust; dose by product

Animal treatment (spray), when needed, high pressure sprayer
42.0% flowable concentrate; 2.1 Ib AI/100 gal water
26.3% wettable powder; 4.0 Ib AI/100 gal water
11.6% emulsifiable concentrate; 3.0  Ib AI/100 gal water
 5.8% emulsifiable concentrate; 2.0 Ib Ai/100 gal water

Animal treatment (spray), when needed, sprayer
42.0% flowable concentrate; 2.1 Ib AI/100 gal water
26.3% wettable powder; 1.0 Ib AI/100 gal water
11.6% emulsifiable concentrate; 1.0  Ib AI/100 gal water
 5.8% emulsifiable concentrate; 1.0 Ib Al/lOOgal water

Animal treatment (wound), when needed, aerosol  can
3.0% pressurized liquid; dose by product

Animal treatment (wound), when needed, high pressure sprayer
11.6000% emulsifiable concentrate;  2.0 lb/100 gal water

Animal treatment (wound), when needed, squeeze applicator
5.0% dust; dose by product

Dip treatment, when needed, vat
42.0% flowable concentrate; 2.551b AI/100 gal water
26.3% wettable powder; 2.5 Ib AI/100 gal water

Pour-on, when needed, no rate specified
4.0% liquid RTU; 0.0015625 Ib AI/100  Ib animal  weight

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 GOATS (MEAT); SHEEP (MEAT)

  Animal treatment (dust), when needed, squeeze applicator
  5.0% dust; dose by product

  Animal treatment (ear), when needed, squeeze applicator
  5.0% dust; dose by product

  Animal treatment (spray), when needed, sprayer
  26.3% wettable powder; 2.0 Ib AI/100 gal water

  Animal treatment (wound), when needed, aerosol can
  3.0% pressurized liquid; dose by product

  Animal treatment (wound), when needed, sprayer
  26.3% wettable powder; 2 Ib AI/100 gal water

  Animal treatment (wound), when needed, squeeze applicator
  5.0% dust; dose by product

  Dip treatment, when needed, vat
  26.3% wettable powder; 2.0 Ib AI/100 gal water

HOG/PIG/SWINE (MEAT)

  Animal bedding/litter treatment, when needed, duster/hand held/mechanical
     duster/shaker can
  1.0% dust; 0.00004125 Ib Al/sq.ft

  Animal treatment (dust), when needed, duster/hand held duster/mechanical
     duster/shaker can
  1.0% dust; 0.000625 Ib Al/animal

  Animal treatment (dust), when needed, squeeze applicator
  5.0% dust; dose by product

  Animal treatment (ear), when needed, squeeze applicator
  5.0% dust; dose by product

  Animal treatment (spray), when needed, sprayer
  26.3% wettable powder; 2.0 Ib AI/100 gal water
  11.6% emulsifiable concentrate; 0.5 Ib AI/100 gal water
   5.8% emulsifiable concentrate; 0.5 Ib AI/100 gal water

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  Animal treatment (wound), when needed, aerosol can
   3.0% pressurized liquid; dose by product

  Animal treatment (wound), when needed, sprayer
   26.3% wettable powder; 2.0 Ib AI/100 gal water

  Animal treatment (wound), when needed, squeeze applicator
   5.0% dust; dose by product

 SHEEP (MEAT); (see GOATS (MEAT))

INDOOR NON-FOOD
 Fur and Wool Bearing Animals
 GOATS (ANGORA ANIMAL); SHEEP (WOOL)

   Animal treatment (dust), when needed, squeeze applicator
   5.0% dust; dose by product

   Animal treatment (ear), when needed, squeeze applicator
   5.0% dust; dose by product

   Animal treatment (spray), when needed, sprayer
   26.3% wettable powder; 2.0 Ib AI/100 gal water

   Animal treatment (wound), when needed, aerosol can
   3.0% pressurized liquid; dose by product

   Animal treatment (wound), when needed, sprayer
   26.3% wettable powder; 2.0 Ib AI/100 gal water

   Animal treatment (wound), when needed, squeeze applicator
   5.0% dust; dose by product

   Dip treatment, when needed, vat
   26.3% wettable powder; 2.0 Ib AI/100 gal water

SHEEP (WOOL), See GOATS (ANGORA ANIMAL)

Specialized Nonfood Animals
HORSES

   Animal treatment (dust), when needed, mechanical duster/shaker
   1.0% dust; 0.00125 Ib Al/animal

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   Animal treatment (dust), when needed, squeeze applicator
   5.0% dust; dose by product

   Animal treatment (ear), when needed, squeeze applicator
   5.0% dust; dose by product

   Animal treatment (spray), when needed, high pressure sprayer
   42.0% flowable concentrate; 2.1 Ib AI/100 gal water

   Animal treatment (spray), when needed, sprayer
   42.0% flowable concentrate; 2.1 Ib AI/100 gal water
   26.3% wettable powder; 2.0 Ib AI/100 gal water
   11.6% emulsifiable concentrate; 2.0 Ib AI/100 gal water
    5.8% emulsifiable concentrate; 2.0 Ib AI/100 gal water

   Animal treatment (wound), when needed, aerosol can
   3.0% pressurized liquid; dose by product

   Animal treatment (wound), when needed, sprayer
   26.3% wettable powder; 2.0 Ib AI/100 gal water
   11.6% emulsifiable concentrate; 2.0 Ib AI/100 gal water
    5.8% emulsifiable concentrate; 2.0 Ib AI/100 gal water

   Animal treatment (wound), when needed, squeeze applicator
   5.0% dust; dose by product
Timing - See above. Used primarily during the early spring to late summer, e.g., the fly season.

             Use Practice Limitations:  Do not apply to lactating dairy cattle at rates above
                                      1 Ib. of CO-RAL 25% Wettable Powder per 100
                                      gallons of water.

                                      Avoid contamination of feed, feed containers and
                                      watering troughs.

                                      Do  not  treat  sheep or goats within 3 days  of
                                      slaughtering.

                                      Do not treat non-lactating dairy cattle at rates above
                                      1 Ib. of CO-RAL 25% Wettable Powder per 100
                                      gallons of water within  14 days of freshening.  If
                                      freshening  should  occur  within  14  days after

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                                 treatment at higher intervals,  do not use milk as
                                 human food for the balance of the 14 day interval.

                                 Do  not  apply to sick, convalescent or stressed
                                 livestock or to animals less than 3 months old except
                                 in Federal or State  eradication  programs (screw
                                 worm, scabies, cattle fever ticks) where immediate
                                 treatment of  all  animals  in an infested  herd  is
                                 mandatory.

                                 Do not dip animals when they  are over-heated.

                                 Do not spray in confined, non-ventilated area.

                                 Do not apply in conjunction with oral drenches or
                                 other internal medications such as phenothiazine.

                                 CO-RAL is a cholinesterase inhibitor. Do not use
                                 this  product on animals simultaneously or within a
                                 few days before or after treatment or exposure to
                                 cholinesterase inhibiting  drugs,   pesticides  or
                                 chemicals.

C.     Estimated Usage of Pesticide

       Exact amounts of coumaphos used or sold in the U.S. are Confidential Business
Information.  However, the following table gives  a  general indication  of which
coumaphos  uses are most prevalent. The predominant uses of coumaphos are on beef
cattle and dairy cattle.  Use on goats, sheep, hogs and horses is a small  component of the
overall usage in the U.S..  It should be  noted that a significant amount of coumaphos
purchased in the U.S., by the USDA for dip vat use, is actually used in Mexico. Cattle
are treated on the Mexican side of the border (to prevent outbreak of Texas Cattle Fever)
prior to being  delivered to feedlots in  the U.S..  It should also  be noted that while
coumaphos  is  an  important animal use  insecticide, its use in the  U.S.  is small when
compared to other agricultural insecticides used on crops.
                                   10

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Application Method
Dip vat use
Dust Bags,
backrubbers, pour-
on, spray, shaker
can, aerosol, etc.
Estimated
40-
55 -
% of Usage
45%
60%
       D.    Data Requirements

             Data requested in the 1981  Registration  Standard  and the  1989 Revised
       Registration Standard for coumaphos included studies on product chemistry, ecological
       effects, environmental fate, toxicology and residue chemistry.  These data were required
       to support the uses listed in the Registration Standard.  Appendix B includes all data
       requirements identified by the Agency for currently registered uses needed to support
       reregi strati on. A Data Call-In (DCI) was issued on Nov 11,  1992 requiring additional
       human neurotoxicity and aquatic toxicity data.  The aquatic toxicity studies required were
       conducted, and the data submitted and reviewed in this reregi strati on eligibility decision.
       The registrant (Bayer Corp.) was granted an extension in submitting the neurotoxicity
       data, due to the large number of active ingredients they are required to test. The acute and
       chronic neurotoxicity data are due April 30, 1998 and Nov 30, 1998, respectively.

       E.    Regulatory History

             Coumaphos was registered in the United States in  1958 for use as an insecticide.
       Data Call-in's were issued in 1981, 1989 and 1992 for coumaphos requiring additional
       data.  A Registration Standard for coumaphos  was issued in September  1989 (NTIS
       #PB90-122243) which evaluated the studies submitted as a result of the 1981 DCI.  This
       Reregi strati on Eligibility Decision reflects  a  reassessment of all  data  which were
       submitted in  response to the Registration Standard and  other acceptable data, e.g.,
       Pesticide Handlers Exposure Database (PHED).
III.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

             Coumaphos [O,O-diethyl O-(3-chloro-4-methyl-2-oxo-2H-l-benzopyran-7-yl)
       phosphorothioate] is an insecticide/acaracide registered for direct application to cattle,
       goats, horses, sheep, and swine.
                                          11

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                                           CH3
                                           1.c,
                           /v
                      hUC,O /  ^CC
                           OC2H5
                    Empirical Formula:         C14H16C1O5PS
                    Molecular Weight:          362.8
                    CAS Registry No.:          56-72-4
Identification of the active ingredient

       Technical coumaphos is a tan powder with a melting point of 90-95 C.  At 20 C,
coumaphos is soluble in acetone (23.82 g/100 ml) and diethyl phthalate (21.50 g/100 ml);
much less soluble in denatured alcohol and xylene (0.9 g/100 ml in each); only slightly
soluble in octanol (0.13 g/100 ml), hexane (0.07 g/100 ml), and mineral spirits (0.09
g/100 ml); and insoluble in water (0.002 g/100 ml). Coumaphos is stable under normal
use conditions, but hydrolyzes slowly under alkaline conditions.
Manufacturing-Use Products

       Two coumaphos manufacturing-use products (MPs) are registered to Bayer, Inc.
(EPA Registration numbers: 11556-11 and 11556-20)

B.     Human Health Assessment

       1.     Toxicology Assessment

           The toxicological data base for  coumaphos is adequate to support risk
       assessment in connection with the reregi strati on eligibility decision. A six month
       ocular toxicity study in dogs, required because coumaphos is an organophosphate,
       is reserved until the Agency develops testing protocols. The acute and subchronic
       mammalian neurotoxicity studies are needed as confirmatory data.
                                   12

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a.    Acute Toxicity
TEST
(81-1) Oral LD50 in rat
(MRID00110597)
(8 1-2) Dermal LD50 in rat
(MRID00110598)
(81-3) 1 Hour Inhalation LC50 in rat
(MRID00110601)
(81-4) Eye irritation in rabbit
(MRID00110599)
(81-5) Dermal irritation in rabbit
(MRID00110600)
(81-6) Dermal sensitization in rabbit
(MRID00110602)
(81-7) Acute neurotoxicity in hen
(MRID00115167)
RESULT
>240 mg/kg - males
17 mg/kg - females
>2400 mg/kg - males and females
1.081 mg/L -males
0.341 mg/L - females
Mild irritant, resolved by day 7
Not irritating
Not a sensitizer
Does not produce
delayed neurotoxicity
CATEGORY
I
III
II
III
IV
N/A
N/A
Acute Neurotoxicity - Mammalian

       This study is required and is considered confirmatory data.

b.     Subchronic Toxicity

Subchronic Oral Toxicity

       Coumaphos was orally administered in a 13-week feeding study to
20 Charles River [Crl: CR (SD)Br] rats/sex/group at dose levels of 0, 2, 5
or 10 ppm (0, 0.2, 0.5 or 1.0 mg/kg/day). Plasma, erythrocyte (RBC) and
brain cholinesterase (ChE) levels were determined at 3, 8 and 13 weeks.
(MRID 00126527)

       Plasma cholinesterase was inhibited throughout the study at all dose
levels in males, but was only statistically significant at 10 ppm (16, 15 and
24%, from low-  to high-dose) and for females at 10 ppm (not significant,
21%). RBC ChE was significantly inhibited in males (18, 34, 50%, from
low- to high-dose) and females (32, 39, 64%, from low- to high-dose) at
all dose  levels  and time points except at  2 ppm  where  significance
occurred only at 13 weeks. Brain ChE was not inhibited at any time.  The
LEL for cholinesterase  inhibition is  equal to or less than  2 ppm  (0.2
                      13

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mg/kg/day) based on RBC ChE inhibition. The NOEL for cholinesterase
inhibition is less than 2 ppm.

      No signs  of systemic toxicity were observed at any dose.  The
systemic LEL and NOEL are greater than 10 ppm (1.0 mg/kg/day).

      This study is not completely acceptable (core-supplementary) due
to deficiencies in the study.  However, a new  study is not  likely to
significantly alter the NOEL or LEL levels, therefore, the Agency will use
the results for risk assessment.

Subchronic Dermal Toxicity

       In a 21-day dermal study coumaphos (98.5%) was administered to
6 male and 6 female Sprague-Dawley [Sas:CD(SD)BR] rats/group at dose
levels of 0, 2, 4, 20 or 100 mg/kg/day.  (MRID 42084901)

      Relative to the concurrent controls at 2 mg/kg/day (LDT), there was
erythrocyte cholinesterase (RBC ChE) inhibition in males (20, 24, 84 and
96% from low- to high-dose) and females (14, 42,  89 and 95% from low-
to high-dose) and plasma ChE inhibition in females (38, 38, 65  and 91%
from low- to- high-dose). At 20 and 100 mg/kg/day, plasma (males 44,
78% for the 2 highest doses) and brain ChE were decreased in males (22
and 59% for the 2 highest doses) and females (26 and  67% for the 2
highest doses) The LEL for cholinesterase inhibition was 2 mg/kg/day
based on RBC  and plasma ChE.  The NOEL for cholinesterase
inhibition was less than 2 mg/kg/day.

      This 21-day dermal study indicates that significant plasma and
brain cholinesterase inhibition occur at approximately the same doses.  As
noted in the next paragraph clinical signs characteristic of neurotoxicity
were also observed at these doses.

      Signs of systemic toxicity occurred at 20 mg/kg/day and above and
included muscle  fasciculation in males (17% and 67% for the 2 highest
dose levels) and females (17 and 100% for the  2 highest dose levels)
sporadically throughout the study.  Tremors occurred in females (17 and
83% at the two highest doses) after the first week and there were anal
stains in males.   At 100 mg/kg/day, there were increased incidences of
hypothermia and activity in females and decreased body weight gains in
males and females. The systemic LEL was 20 mg/kg/day based on muscle
fasciculation and tremors. The systemic NOEL was 4 mg/kg/day.
                      14

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       This study is not completely acceptable (core-supplementary: a
NOEL for ChE was not determined) when considered alone and is not
acceptable for regulatory purposes. However, the study is considered to
be acceptable when taken together with a second study conducted using
lower doses in females (MRID 42666401).

       In a 21-day dermal study, technical grade coumaphos (99.1%) was
administered to 5 female Sprague-Dawley [Sas:CD(SD)BR] rats per group
at dose levels equivalent to 0,  0.1, 0.5,  1.1 or 2.1 mg/kg/day.  (MRID
42666401)

       At 1.1 mg/kg/day, RBC ChE was inhibited (24 and 28% for the two
highest doses).  The LEL for cholinesterase inhibition was 1.1 mg/kg/day
based on inhibition of RBC ChE in females.  The NOEL for cholinesterase
inhibition is 0.5 mg/kg/day.

       There  was no systemic toxicity observed at any dose level. The
systemic LEL is greater than 2.1 mg/kg/day.  The systemic NOEL is 2.1
mg/kg/day  (4 mg/kg/day based on a separate study).  This study is
considered acceptable when taken together with the study cited above, i.e.,
MRID 42084901.

       When the two studies are considered together, the NOEL and LEL
for systemic effects are 4 and 20 mg/kg/day, respectively.  The NOEL and
LEL for cholinesterase inhibition are 0.5 and 1.1 mg/kg/day, respectively.

c.     Chronic toxicity

       1)   Rat:  In a 2-year chronic  feeding/carcinogenicity study,
technical grade coumaphos (99.2%) was fed to groups of 70 SPF Wistar
[Bor:WISW(SPF Cpb)] rats/sex at dose levels of 0, 1, 5 or 25 ppm in the
diets (males - 0, 0.05, 0.25 or 1.22 mg/kg/day; females - 0, 0.07, 0.36 or
1.70 mg/kg/day).  (MRIDs 40836001,  40955801)

       Body weight gain of females in the 25 ppm group was marginally
decreased by up to 4% throughout the study, but the effect is considered
to be treatment related. The systemic NOEL and LEL are 5 ppm (0.36
mg/kg/day) and 25 ppm (1.70 mg/kg/day) in females, respectively, based
on decreased body weight gain.

       Plasma cholinesterase (ChE) was decreased in males in the 25 ppm
group (up to 43%), and in females in the 5  ppm (up to 27%) and 25 ppm
(up to 53%) groups.  Erythrocyte ChE was decreased in males in the 25
                      15

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ppm group (up to 28%), and in females in the 5 ppm (up to 11%) and 25
ppm (up to 34%) groups.  The NOEL (ChE) and LEL (ChE) are 5 ppm
(0.36 mg/kg/day) and 25 ppm (1.70 mg/kg/day) in females, respectively.

      There was no evidence of carcinogenicity at any dose.  Dosing was
adequate to evaluate carcinogenic potential.

      In a second carcinogenicity study, coumaphos TGAI (95%) was
administered to groups of 50 F344 rats/sex at dose levels of 10 or 20 ppm
in the diet for 103 weeks.  The control group contained  25  rats/sex.
(MRID 05009938)

      Body weights of female rats were slightly lower than the controls
at 10 and  20 ppm. Decreases in male body weight was observed at 20
ppm. No other toxic manifestations were apparent.   There was  no
evidence that administration of coumaphos was associated with an increase
in tumors.  Dosing was considered adequate to evaluate carcinogenic
potential.

      2) Mouse:  In a carcinogenicity study technical grade coumaphos
(95%) was administered to groups of 50 B6C3F1 mice/sex at dose levels at
10 and 20 ppm in the diet for  103 weeks. The control group contained 25
mice/sex.  (MRID 05009938)

      No toxic manifestations were apparent. There was no evidence that
administration  of coumaphos was associated with an increase in tumors.
Dosing was considered adequate to evaluate carcinogenic potential based
on  range-finding  data.   It  was  expected  that ChE would have  been
inhibited if the measurement was evaluated.

      3) Dog: In a 1-year feeding study male and female Beagle dogs (4
per sex/group) were given technical grade coumaphos (98.0-99.0%) in the
diet at concentrations of 1, 30, or 90 ppm (equivalent to 0.025, 0.775, or
2.295 mg/kg/day for males, and 0.024,  0.705, or  2.478 mg/kg/day  for
females, respectively). Control groups received untreated diet. (MRID
43055301)

      When compared to  pretreatment levels, plasma  cholinesterase
(ChE) and erythrocyte cholinesterase (RBC ChE) activity levels  were
significantly depressed (p<0.05) in the 30 and 90 ppm exposure groups.
Specifically, plasma ChE levels in the 30 ppm males at 91, 182, 273, and
363 days were 62.5%, 73.6%, 72.1%, and 76.1% less than pretreatment
values and in the 30 ppm females were 53.8%, 62.0%, 61.7%, and 72.1%
                     16

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less than pretreatment levels. In the 90 ppm groups, plasma ChE activity
at days 91,  182, 273,  and 363 were depressed 70.8%, 73.8%, 80.2% and
77.9% (males) and 74.4%, 76.5%, 73.4%, and 84.4% (females). For RBC
ChE activity levels in the 30 ppm group at these time points, the respective
values were 41.9%, 37.3%, 42.4%, and 46.6% (males), and 49.3%, 33.9%,
42.1% and 42.9% (females) of respective pretreatment values. RBC ChE
activity levels in the 90 ppm group at days 91, 182, 273, and 363, were
76.9%, 66.2%, 75.2%, and 59.7% (males), and 79.2%, 75.1%, 82.1% and
75.6% (females)  less than  the pretreatment values.   Comparison to
concurrent  controls and evaluation of brain cholinesterase  and ocular
muscle cholinesterase at the termination of the study corroborated these
findings.  Although some statistically significant plasma ChE depression
was also observed in females in the 1 ppm group, the difference could be
attributed to the  high  degree  of individual  variability.  Based upon
significant and biologically relevant depression of RBC ChE and plasma
ChE activity levels  in dogs, this study provided a NOEL of 0.025
mg/kg/day and a LEL of 0.7 mg/kg/day.

       There were no  other treatment related systemic changes at any dose
level. The  systemic NOEL was 2.3 mg/kg/day and the LEL was greater
than 2.3 mg/kg/day.

d.     Carcinogenicity Classification

       Coumaphos was  classified by  the  HED RfD/Peer Review
Committee on October 13, 1994 as a "Group E", i.e., evidence of non-
carcinogenicity for humans, based on adequate studies in two animal
species.

e.     Developmental Toxicity

       1) Rat:  In a developmental toxicity study, coumaphos (TGAI) was
administered by gavage to groups of 28 Charles River CDBS rats at dose
levels of 0, 1, 5 or 25 mg/kg/day during day 6 to 15 of the gestation period.
(MRID00131684)

       Three females  in the 25 mg/kg/day group exhibited tremors and 2
of these showed additional signs of mild anticholinesterase-type toxicity.
The NOEL and LEL for maternal toxicity were  5 mg/kg/day and 25
mg/kg/day, respectively, based on clinical signs of cholinesterase toxicity.
No developmental effects were observed.   The NOEL and LEL for
developmental toxicity was greater than or equal to 25 mg/kg/day.
                      17

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      2) Rabbit: Technical coumaphos was administered by gavage to
groups of 17 American Dutch rabbits at dose levels of 0, 0.25, 2.0 or 18.0
mg/kg/day during days 7-19 of gestation.  Maternal toxic signs, including
death and abortion,  were observed in the 18.0 mg/kg/day group.  The
NOEL and LEL for maternal toxicity  were 2.0  mg/kg/day and  18.0
mg/kg/day, respectively. No developmental effects were observed.  The
NOEL for developmental toxicity was 18.0 mg/kg/day.  The LEL for
developmental toxicity  was greater  than 18.0 mg/kg/day.   (MRID
00131683)

f.     Reproductive Toxicity

      In a  two-generation reproduction study Sprague-Dawley rats
(30/group) received technical coumaphos (99%) in the diet at dose levels
of 0, 1, 5, or 25 ppm. These dose levels correspond to approximately 0,
0.07, 0.30, and 1.79  mg/kg/day for F0 males and 0, 0.08,  0.34, and 2.02
mg/kg/day  for F0 females respectively, during  premating.   (MRID
43061701)

      Cholinesterase inhibition, observed at 5 and 25 ppm was manifested
as dose-related decreases in erythrocyte (RBC) and plasma cholinesterase
(ChE).  The  RBC ChE was inhibited 31-70%, relative to concurrent
controls, at 5  ppm and 53%-95% at 25 ppm.  Generally,  no differences
were noted between Day 47 (or 56) and Day 91 ChE levels.  Brain levels
were biologically significantly inhibited (»30%) in F0 and  Fx females. In
pups, plasma  and RBC ChE levels were inhibited (31%-44%) at 25  ppm
on lactation day 21 but not on lactation day 4. Based on these results, the
NOEL and LEL for ChE inhibition were 1 and 5 ppm, respectively.

      There  were no other signs of systemic toxicity. The NOEL and
LEL for systemic  toxicity was  equal  to or  greater than 25  ppm.
Reproductive toxicity was not observed in this study.  Consequently, the
NOEL for reproductive toxicity was 25 ppm and the LEL for reproductive
toxicity was greater than 25 ppm.

g.    Mutagenicity

      1) Gene Mutation

      A Salmonella/microsome study was conducted. Coumaphos was
not mutagenic when tested at levels up to 12,500 //g/plate with and without
metabolic activation in Salmonella typhimurium strains TA1535, TA1537,
TA100, andTA98.  (MRID 00131680)
                      18

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      2)  Structural Chromosomal Aberration

      Coumaphos was tested in a mouse-micronucleus test at levels up to
1920 mg/kg by gavage.  Negative results were obtained at 480 mg/kg.
Cytotoxicity was observed at dose levels above 480 mg/kg. Mortality was
observed  at  higher  dose  levels making the  results  uninterpretable.
(MRIDs: 41847501, 42254501)

      3)  Direct DNA Damage and Repair

      A Pol A test on Escherichia coli was conducted. Coumaphos was
not mutagenic when tested at levels up to 5000 //g/plate with and without
metabolic activation.  (MRID 00131681)

h.    Metabolism

      Radiolabeled coumaphos was  administered to rats  at dose levels of
1.0 mg/kg intravenously and 1.0 and 15.0 mg/kg, orally.  A fourth group
received 1.0 mg/kg coumaphos daily for 14 days. (MRID 01155611)

      The plasma half life ranged from 2.35 to 3.30 hours at 1.0 mg/kg
(including the repeated dose group) and 2.93 to 5.30 hours at 15.0 mg/kg.
Urinary  excretion was rapid with 63-87% of the administered dose being
excreted within 24 hours.  76-96% of the administered dose was excreted
within 168 hours. Tissue residues were highest in fat, kidney, liver  and
muscle.  The urine contained 5 to 8 metabolites and the feces contained 5
to 7 metabolites. The major metabolite is chlorferone (the hydroxylated
leaving group). Coumaphos represented 0.1% of the urinary metabolites.
Coumaphos represented 0.2% of the fecal metabolites when  administered
intravenously.    However,  when  administered  orally  coumaphos
represented approximately 15 to 55% of the fecal metabolites.  The range
varied depending on whether coumaphos was  administered as a single
dose or repeated  dose.

i.     Endpoints Used for Risk Assessment

      Acute Dietary Exposure

      The endpoint  for  acute dietary risk assessment is the  RBC ChE
inhibition NOEL (0.2 mg/kg/day) from  the 13-week rat dietary study
(MRID  00126527).  The LEL (0.5 mg/kg/day)  is based  upon RBC ChE
inhibition. Although the above endpoint was observed at 21 days (earliest
time point measured) there is no reason to believe that the inhibition did
                      19

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not occur within the first week of exposure.  The RBC ChE inhibition
observed at 0.2 mg/kg/day is not appropriate for this exposure scenario
since it was only statistically significant at 13 weeks not at 3 weeks.
Effects (RBC ChE inhibition) were noted at 0.2 mg/kg/day at 13 weeks but
not at earlier time intervals. Therefore, the 0.2 mg/kg/day is considered a
NOEL for exposures of less than 13 weeks.

       Short-term Occupational Exposure (1-7 days)

       The endpoint  for  short-term occupational  or residential risk
assessment is  the RBC ChE NOEL (0.5 mg/kg/day) from the 21-day
dermal rat study (MRID 42666401). The LEL (1.1 mg/kg/day) is based
upon inhibition of RBC ChE. Although the above studies are 21 days in
duration there is no reason to believe that the inhibition would not or did
not occur within the first week of exposure.

       Intermediate-term Occupational or Residential Exposure (1-Week
       to Several Months)

       The endpoint for intermediate-term occupational or residential risk
assessment is  the RBC ChE NOEL (0.5 mg/kg/day) from the 21-day
dermal rat study (MRID 426664-01). The LEL (1.1 mg/kg/day) is based
upon inhibition of RBC ChE.

j.      Reference Dose

       The RfD/Peer Review Committee recommended, in the October 13,
1994 meeting, to establish the RfD for coumaphos based on the NOEL of
0.025 mg/kg/day observed in the newly submitted  1-year dog chronic
toxicity study (MRID 43055301). Plasma and erythrocyte ChE inhibition
was observed at the next highest dose level of 0.775 and 0.705 mg/kg/day
in males and females, respectively. An uncertainty factor of 100 was
applied to account  for inter-species  extrapolation and  intra-species
variability.  On this basis, the RfD was calculated to be 0.007 mg/kg/day.
It should be mentioned that this chemical had been reviewed in 1990 by
the FAO/WHO Joint Committee on Pesticide Residue (JMPR). However,
an acceptable daily intake (ADI) was not established.
                      20

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2.     Exposure Assessment

      a.     Dietary Exposure

      Plant Metabolism

             There are no registered uses for coumaphos  on crops.  Plant
      metabolism data are not necessary or required.

      Animal Metabolism

             The qualitative  nature of the residue in ruminants is adequately
      understood based  on  an adequate metabolism study reflecting dermal
      exposure to lactating cattle. The residues of concern are coumaphos and
      its oxygen analog.  The salient features of the dermal treatment study are
      summarized below.

             One cow received [phenyl-14C]coumaphos treatment daily for two
      consecutive days. The test substance totalling 2.252 g was poured along
      the center line of the back.  Milk was collected twice a day and the cow
      was sacrificed and tissues collected 24 hours after the second dose.  The
      total radioactive residue (TRR) in milk plateaued at 0.022 ppm after 36
      hours; the maximum residues in milk were 0.023 ppm at 48 hours. At the
      treatment site, TRR were 3.019 ppm in subcutaneous fat and 0.425 ppm in
      muscle. TRR in other tissues were 0.054 ppm in kidney, 0.03 ppm in liver,
      0.003 ppm in muscle, and 0.021-0.043 ppm in fat. Coumaphos was the
      major residue accounting for 70-96% of the residue in tissues from the
      treatment site.  Neither coumaphos oxygen analog nor the metabolite
      potasan    [O,O-di ethyl     O-(4-m ethyl-2-oxo-2H-l-benzopyran-7-yl)
      phosphorothioate] was  detected. As the registrant has canceled uses on
      poultry, there is no requirement for poultry metabolism data.

      Residue Analytical Methods - Animals

             Adequate methodology is available for enforcement of animal
      commodity tolerances.  A fluorophotometric method is published in PAM,
      Vol. II as Method I. This method does not distinguish between coumaphos
      and the oxygen analog. An improved method, method 74310, uses GC
      with NPD  (nitrogen-phosphorus detector)  detection and distinguishes
      between coumaphos and its oxygen analog.  The detection limits for each
      analyte are 0.01 ppm in milk and 0.05 ppm in tissues.  Method 74310 was
      successfully validated by an independent laboratory after modifications.
                            21

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The modified method will be submitted to the Agency and validated at the
EPA Beltsville Laboratory.

       The FDA PESTDATA database dated 1/94 (PAM Vol. I, Appendix
II) indicates that coumaphos  and its oxygen analog are completely
recovered (>80%) using multiresidue method PAM Vol. I Section 302
(Luke method). Coumaphos is completely recovered using Section 304
(Mills  fatty  food method), although recovery may vary with  choice of
Florisil elution system; the oxygen analog is not recovered using Section
304.  Neither analyte is recovered by Section 303 (Mills, Onley, Gaither
method).

Storage Stability Data - Supporting Residue Studies

       Adequate storage  stability  data are available for meat  and milk.
Milk samples with residues bearing 0.19 ppm of coumaphos and 0.15 ppm
of coumaphos oxon were stored up to 75 weeks with no change in residue
levels.  Residue levels in cattle tissue from the various types of treatment
indicate stability whether the samples were stored frozen for less than 30
days or greater than 30 days.  In addition, coumaphos residue levels in
muscle from  the dermal metabolism study were relatively stable after one
year of frozen storage.

Magnitude of the Residue in Meat Milk. Poultry, and Eggs

       Numerous magnitude of residue studies for cattle, goats,  hogs, and
sheep are available reflecting the current types of registered external uses
(dusts, sprays, dips, pour-ons, backrubbers, and bedding treatments).  The
August 1981 Residue Chemistry  Science Chapter  of the Registration
Standard summarized the studies by use and by livestock, and highlighted
maximum application rates and maximum residues found. Application
rates reported in the reviewed studies range from being the same as, to
being substantially higher  than, currently registered maximum rates.
Intervals between treatments reflected current uses, with zero to 14 days
elapsing between treatments. Residues in cattle from dermal treatments
were <0.02 ppm in milk and up to 0.1 ppm in muscle, 0.2 ppm in liver and
kidney, and 0.7 ppm in fat. Goat and sheep fat contained up to 1  ppm and
0.2 ppm, respectively. In swine, residues up to 0.58  ppm in fat and 0.64
ppm in meat were found.
                      22

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b.     Occupational and Residential

       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)
during use or to persons entering treated sites after application is complete.

Handler (Mixer/Loader/Applicators) Exposures

       The Agency believes that there is potential exposure associated
with  coumaphos  use to  handlers, including  mixers,  loaders,  and
applicators. The Agency is concerned about potential exposures arising
from  mixing, loading, and  application  of emulsifiable-concentrate,
flowable-concentrate  and wettable-powder  formulations,  but  also
application by pouring on ready-to-use liquid,  and application with
backrubbers,  foam,  pressurized liquid,  dust  bags,  shaker cans,  and
mechanical  dusters.   The greatest potential for  coumaphos exposure
appears to exist in the livestock dip vat use and with handheld sprayers,
due to the sheer amount of material handled.

       Based on the registered uses of coumaphos there are  eight different
exposure scenarios: (1) mixing/loading/application of the liquid from a
high or low-pressure handwand sprayer, (2) application by foam spray can,
(3) mixing/loading/application of dipping solutions,  (4)  application of
ready-to-use,  pour-on  solutions,   (5)   application  of  backrubber
formulations, (6) application with dust bags, (7) application of dust with
shaker cans, and (8)  application with mechanical dusters.  The different
exposure scenarios are discussed further in the risk assessment section of
this RED.

       Coumaphos-specific handler exposure data are not available and
were  not required in  the Coumaphos  Registration Standard  (1989).
Additionally,  no  exposure data  currently  are available in Pesticide
Handler's Exposure  Data (PHED)  specifically for animal treatments.
However, applicable handler exposure data are available in PHED for
mixing/loading of liquid  and wettable-powder formulations and  for
application with handheld spray equipment. The  Agency believes that
given the registered uses of coumaphos these exposure data will provide
a reasonable  frame of reference to roughly assess the risks to handlers
mixing, loading, and applying coumaphos, especially for the spray and
dip-vat applications where there is the greatest potential for significant
exposure.
                      23

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       No  coumaphos-specific  or  generic (PHED) data  are  currently
available to assess exposures resulting from (1) loading and  applying dust
formulations, (2) applying ready-to-use livestock pour-on  solutions, (3)
ready-to-use livestock foam formulations, or (4)  livestock  backrubbers.

       The assessment for handler exposure to coumaphos associated with
spray applications incorporates the following assumptions:

       • a typical (or average) herd size ranges from 50-100 head;

       • a maximum herd size ranges from 500-1000 head of cattle;

       • the treatment rate of spray per animal is one gallon.

       Therefore, spraying  an entire typical herd of 100 animals would
require  mixing/loading  and   spraying   100  gallons  of   dilute
coumaphos/water mixture.   The maximum  spray  application rate for
coumaphos is 4.0  pounds of active ingredient (a.i.) per 100 gallons of
water, while the maximum dilution rate or minimum use rate is 0.5 Ibs a.i.
per 100 gallons for all coumaphos products labeled for spraying.  Thus a
mixer/loader preparing to spray  a typical herd would handle at least 0.5
pounds of coumaphos per day while  mixing/loading, assuming  the
livestock are treated with the most dilute solution. Likewise at the same
use rate, a mixer/loader preparing to spray the maximum herd size would
handle 5.0  pounds of coumaphos per day while  mixing/loading. These
estimates are based on the upper limits of the typical and maximum herd
sizes  and the  most dilute application rate of 0.5 Ibs a.i./lOO gallons.
Calculation of  the  exposure to  applicators using hand-held  spray
equipment  also assumes they are handling 0.5 Ib ai/day  to 5 Ib a.i./day,
depending on the size of the herd they are treating.

       The assessment for handler exposure to coumaphos associated with
dip-vat applications incorporates the following assumptions:

       •     mixers/loaders   handling  liquid  (emulsifiable
             concentrate) formulation at a rate  of  10 pounds  of
             active  ingredient  per  day  for  a small dip-vat
             operation (ca. 450 gallons) and 22 pounds  active
             ingredient per day for a large dip-vat operation (ca.
              1000 gallons).

       •     mixers/loaders    handling   wettable   powder
             formulation at a rate of  11.25 pounds of  active
                      24

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                              ingredient per day for a small dip-vat operation and
                              25 pounds active ingredient per day for a large dip-
                              vat operation.
COUMAPHOS UNIT EXPOSURE ESTIMATES RESULTING FROM OPEN-SYSTEM
MIXING/LOADING OF LIQUIDS AND WETTABLE POWDERS FOR LIVESTOCK SPRAYING
(jig/lb ai)
Usage Scenario
Livestock Spraying
(liquid formulations)
Livestock Spraying
(wettable powders)
Dermal
Exposure
22.8
148.7
Hand
Exposure
30.6
12.4
Total Dermal
Exposure
53.4
161.1
Inhalation
Exposure
0.1333
4.2
The total dose was calculated by multiplying the unit exposure times the maximum application rate times
the maximum amount of material handled divided by 70 kg, i.e.:

        dose = [dermal & inhalation exposure X amount handled]/body weight.

NOTE: Conversion factors are used as necessary to express in consistent units.
COUMAPHOS UNIT EXPOSURE ESTIMATES RESULTING FROM OPEN-SYSTEM
MIXING/LOADING OF LIQUIDS AND WETTABLE POWDERS FOR DIP VAT OPERATIONS
(ug/lb ai)
Usage Scenario
Recharge Dip Vat
(liquid formulations)
Recharge Dip Vat
(wettable powder)
Dermal
Exposure
71.0
148.7
Hand Exposure
25.7
12.4
Total Dermal
Exposure
96.7
161.1
Inhalation
Exposure
0.1041
4.2
COUMAPHOS UNIT EXPOSURE ESTIMATES RESULTING FROM HANDHELD SPRAYER
APPLICATION TO LIVESTOCK (jig/lb ai)
Application
Method
Handheld Sprayer
Dermal Exposure
823.7
Hand Exposure
26.9
Total Exposure
850.6
Inhalation
Exposure
6.3
                                        25

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      Post-Application Exposures and Assumptions

             EPA has determined that there is likely to be some exposure to
      persons  contacting treated  animals immediately after  application is
      complete.  No exposure data are available to assess the risk from such
      contact.  However, EPA has determined that the amount of exposure is
      likely to be substantially  lower than the  exposure mixers and loaders
      receive in  handling coumaphos to prepare spray  solutions for a typical
      (average) herd size.   Therefore, no post-application exposure data are
      required.

3.    Risk Assessment

      a.     Dietary

             The reference  dose (RfD) for coumaphos is exceeded using the
      Theoretical Maximum Residue Contribution (TMRC) for the overall U.S.
      population from published tolerances.  However, this exposure estimate
      and RfD calculation  includes exposure to  coumaphos residues at the
      tolerance level in poultry and eggs.  There are currently no registered uses
      of coumaphos on poultry.  Additionally, use of coumaphos on poultry is
      not being supported in reregi strati on. In order to more accurately define
      the  dietary exposure  to coumaphos residues the  Agency conducted  a
      second, more  refined, analysis using anticipated residues for only those
      commodities with registered uses, i.e., excluding poultry and eggs.

      Chronic Exposure Using Anticipated Residues:

             The Anticipated Residue Contribution (ARC) for the overall U.S.
      population from published uses supported in reregi strati on  are  listed
      below. Anticipated residues are average or the typical amount of residue
      present and are considered appropriate to use for chronic exposure.

      Subgroup           Exposure (mg/kg/day)      %Reference Dose

      U.S. population     0.000098                  39
      Children (1-6 years)  0.000183                  73

             When only the supported uses  are considered the ARCs for the U.S.
      population and all ORES subgroups  are well below the Reference Dose.
      When poultry and eggs are not considered in the chronic dietary risk
      assessment the chronic dietary risk posed from  coumaphos is not of
                            26

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concern.  These  uses are not being supported in reregi strati on.  The
coumaphos tolerances for poultry and eggs need to be revoked.

Acute Exposure

      A detailed dietary acute exposure analysis evaluates individual food
consumption as reported by respondents in the USD A 1977-78 Nationwide
Food Consumption Survey (NFCS) and estimates the distribution of single
day exposures  through the diet for the U.S.  population and certain
subgroups.  The analysis assumes uniform distribution of coumaphos in
the commodity supply.  Since the toxicological effect to  which high end
exposure is being  compared in this analysis is red blood  cell and plasma
cholinesterase inhibition,  all subgroups are of concern.  For substances
whose acute NOEL is based on an animal  study, the Agency is not
generally concerned unless the MOE is below 100.

      High end or maximum anticipated residues (ARs), i.e, conservative
or very protective  of human health, were evaluated.  Only uses  of
coumaphos supported in reregistration were included in the acute analysis,
i.e., poultry and eggs were not included in the acute risk assessment. High
end ARs, were used to calculate the high-end exposure for all subgroups
from  meat and milk. The MOEs  for each subgroup are listed in the
attached table. The high end MOE is for the 100% of the U.S. population.
The percentile at which the MOE reaches 100 is listed in parenthesis. For
example, consider the U.S. population category.  The 100% percentile has
an MOE of  63, while an MOE of 100 is reached at the  98%  percentile
level.  Roughly, this means that there is a 2% chance that  an individual in
this category (U.S. population) will  have an MOE less than 100.
ORES Subgroup
U.S. pop. (48 states)
Infants (< 1 year)
Children(l-6 years)
Females(13+ years)
Males(13+ years)
High end
Exposure
(mg/kg/day)
0.0032
0.006
0.006
0.002
0.0024
High end
MOE
63
33
33
100
83
Percentile at which
MOE is acceptable
(98th) 100
(95th) 100
(90th) 100
_
(99th) 100
       The table of distribution of exposures includes the MOEs for five
subgroups.  The calculated MOEs are  lower than  100 (at the 100th
                      27

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percentile level) for four of the five subgroups used in the DRES acute
program. For the children (1-6 years) subgroup, the MOE does not reach
100 until the 90% percentile.

       It should be noted that the dose required to produce RBC/ChE
inhibition at three weeks was used to perform the acute dietary (single
dose) risk assessment.  This approach would overestimate the dose that
would be expected to produce ChE inhibition from a single exposure.
Actual MOEs are  expected to be near 100.

       Two additional acute analyses were conducted to further define the
exposure  and  the acute dietary risk  from coumaphos.   One analysis
considers only milk and the other considers only beef products.  Although
this is not the method of acute risk assessment generally preferred by the
Agency, the analysis helps identify higher risk commodities.

Acute Analysis Results for Coumaphos on Milk Only:
Subgroup
U.S. Population
Infants <1
Children 1-6
Females 13+
Males 13+
High End
MOE
100
50
67
333
250
Percentile
MOE

100 (85%)
100 (99%)


Acute Analysis Results for Coumaphos on Beef Only:
Subgroup
U.S. Population
Infants <1
Children 1-6
Females 13+
Males 13+
High End
MOE
100
67
67
100
100
Percentile
MOE

100 (98%)
100 (98%)


                      28

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       Although the acute analysis on milk for the infant subgroup does
not reach an acceptable MOE until the  85 percentile, it is generally
considered that infant formula is a mixed or blended commodity and not
taken directly from one dairy cow. Any such mixing or blending would
tend to reduce the variability in residue levels in the composite samples
which people would consume.  This would reduce the likelihood of
consuming milk with residue levels at or near the maximum ever observed,
i.e., 0.017 ppm.  The upper bound residue estimate was estimated to be
0.02 ppm  for milk, while the average residue was estimated to be 0.006
ppm in milk. The practical effect of mixing or blending would be to lower
the maximum residue observed in the composite sample, making it closer
to the average or median estimated value. In addition, neither of these
analyses considers the effect of processing (e.g. pasteurization) or cooking
which would likely reduce coumaphos levels.

       Neither analysis considers the effect of processing and or cooking
on residues levels  because these data are not available.  The original
analysis  also assumes that  both  meat and milk are  consumed with
coumaphos  residues present in both commodities at the highest level
observed in the feeding studies. Although this is certainly possible, it is
highly unlikely and it should be considered as conservative, i.e., very
protective of public health.

b.     Occupational and Residential

       A NOEL of 0.5 mg/kg/day (cholinesterase inhibition) derived from
a 21-day  dermal rat study was used to estimate MOE's.  Because the
effects discussed above  are from a dermal study, no dermal absorption
adjustment is necessary.  An average handler body weight of 70 kilograms
is used in the risk  assessment. Inhalation exposures did not contribute
significantly to the total exposure and consequently were not used in the
MOE calculations.

Risk is calculated as follows:
Dose (mg/kg/day) =  Exposure (mg/day)	
                    Worker Body Weight (70 kg)

MOE=      NOEL (0.5 mg/kg/dav^)	
             Dose (mg/kg/day) x Dermal Absorption (100%)
                      29

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       Even  with the uncertainties in the  data  (which may  either
overestimate or understate the risk), the Agency is concerned with the low
MOEs for certain handler exposure uses. MOEs of less than 100 trigger
a risk concern when the toxicity endpoint is based on animal tests.

       The calculated MOE's are presented in the following tables. The
calculations indicate that:

•      MOEs are less than 100 for handlers mixing and loading (1)
       wettable powder formulations to prepare spray for the maximum
       herd size, (2) liquid (emulsifiable  concentrate) formulations to
       prepare dip-vat solutions for small and large dip-vat operations, and
       (3) wettable powder formulations to prepare dip-vat solutions for
       small and large dip-vat operations.

•      MOEs are less than 100 for handlers applying spray to livestock
       with handheld equipment for both  the typical herd size and the
       maximum herd size.

•      MOEs are greater than 100 for handlers mixing and loading liquid
       (emulsifiable concentrate) formulations to prepare spray for the
       typical and maximum herd size.

       The various exposure scenarios corresponding to  the different
registered uses of coumaphos are summarized in the table below along
with the corresponding exposure/risk assessment. All Margin of Exposure
(MOE) calculations are derived from the 21-day dermal rat NOEL of 0.5
mg/kg/day. The minimum use rate was used (0.5 Ibs ai/100 gallons) to
calculate MOEs for spray application, MOEs for the maximum application
rate (4 Ibs ai/100 gallons) are therefore lower by a factor of 8.
                      30

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COUMAPHOS EXPOSURE ESTIMATES RESULTING FROM OPEN-SYSTEM
MIXING/LOADING OF LIQUIDS AND WETTABLE POWDERS FOR LIVESTOCK SPRAYING
AND DIP VAT OPERATIONS (mg/kg/day)
Usage Scenario
Typical Spraying
Typical Spraying
Max Spraying
Max Spraying
Small Dip Vat
Small Dip Vat
Large Dip Vat
Large Dip Vat
Formulation
Powder
Liquid
Powder
Liquid
Powder
Liquid
Powder
Liquid
Dermal
Exposure
1.2xlCr3
3.8xlCT4
1.2xlCr2
3.8xlCr3
2.6xlCr2
1.4xlCr2
5.7xlCr2
3xlO-2
Inhalation Exposure
3xlO'5
9.5xlCT7
3xlO'4
9.5X1CT6
6.8xlCr4
l.SxlCT5
l.SxlCT3
3.3xlCT5
MOE
434
1,311
43
131
19
36
9
16
       The total dose (not shown) was calculated by multiplying the unit exposure times
the maximum application rate times the maximum amount of material handled divided
by 70 kg.

       The Margin of Exposure for the vat use was calculated to range from 9 to 36
assuming a 1000 gallon "topping off or recharging of the dip vats after animals moving
through the vats have depleted the liquid level.  When the dip vats are filled, up to 4000
gallons of solution are handled. This means that the MOEs associated with filling the vats
from empty are smaller by up to a factor of 4 (MOE 2.2 to 9).  The Agency understands
that totally emptying and refilling a dip vat typically occurs between six to 24 months.
COUMAPHOS EXPOSURE ESTIMATE RESULTING FROM SPRAY APPLICATION OF
LIQUIDS TO LIVESTOCK (mg/kg/day)
Applicator
Typical Spray
Maximum Spray
Dermal
6.1xlCr3
6.1xlCr2
Inhalation
4.5xlCr5
4.5xlCr4
MOE
82
8.2
             The following comments pertain to the registrant's PHED runs:

             o      The Agency's PHED policy prohibits the analysis of different solid
                    formulations in the same run due to their  variable exposure
                                   31

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       potential.  Granulars, pellets and wettable powder all have different
       potential unit exposure values.  Only different liquid formulations
       may be analyzed in the same analysis.

o      The Agency's PHED runs reflect the closest Ibs ai handled that are
       available in PHED.

o      There are no open Mixer/Loader dust formulation data in PHED.
       Data are needed to support dust formulation uses.

o      Wettable  powder  data were  only available at  the  ABC grade
       (medium confidence) level.

o      The Agency's policy is to view water soluble bags as a closed
       loading system. Therefore, these data are not included for analysis
       on wettable powder and dust formulations.

o      For the purpose of  determining an  estimated exposure for the
       handheld sprayer, studies were combined representing low pressure
       handwand, high pressure handwand, and handgun sprayer.  This
       exposure value  is also based on medium confidence data (ABC
       grade).

o      The PHED data for mixing and loading the liquid formulation were
       subsetted to more closely reflect the two scenarios of concern. For
       mixing/loading to support spraying with hand equipment, the data
       were limited to exposure scenarios where up to and including 5.0
       Ibs ai were handled per day. For mixing/loading to support dip-vat
       operations, the  data were limited to exposure  scenarios where
       between 10 to 24 Ibs ai were handled per day.

o      Each exposure assessment is based on the workers wearing
       long pants, long sleeved shirts and chemical-resistant gloves.

Risk From Post-Application Exposures

       EPA has determined that the risk from post-application exposure
is likely to be substantially lower than the risk mixers and loaders receive
in handling coumaphos to prepare spray solutions for typical  herd size. The
risk assessment indicates that the risk to such mixers and loaders is greater
than 100. Based on this rough post-application exposure and risk estimate,
EPA has determined that post-application exposures do not appear to pose
                      32

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an unreasonable risk to persons contacting treated animals, as long as
contact is not permitted immediately after application.

Additional Occupational Exposure Studies

Exposure Studies for Handlers (Mixers/Loaders/Applicators)

      Requirements  for  mixer/loader/applicator  (handler)  exposure
studies are addressed  in Part V. Exposure studies are required for the
following exposure scenarios:

      o     Mixing/loading/application of dipping solutions for both the
             liquid and wettable formulations (The Agency will use
             these data to represent all mixing/loading operations, e.g.,
             backrubber and dust bag setup).

      o     Application by shaker can, mechanical duster, pour-on and
             foam spray can.

      o     Mixing/loading/application of liquid and wettable powder
             formulations  from a  high and  low-pressure handwand
             sprayers.

      The registrant has proposed conducting exposure studies for only
the "worst case" exposure scenarios.  The Agency is willing to consider
these arguments provided the registrant is willing to agree to accept the
resulting MOEs as applying to all uses.

Exposure Studies for Post-Application Workers

      Post-application exposure studies are not required.
                      33

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C.    Environmental Assessment

      1.     Environmental Fate

             This section describes the environmental fate characteristics of coumaphos,
      its persistence in the environment, mobility, major route(s) of degradation, identity
      of degradates,  and the potential of the pesticide to contaminate surface and/or
      ground water.

             In addition to normal environmental fate data requirements, the Agency
      required studies concerning the environmental fate of coumaphos after dermal
      treatment of cattle for control of cattle grubs, ticks, flies and lice. These studies
      characterize coumaphos exposure to nontarget terrestrial and aquatic animals.  The
      studies estimate the amount of coumaphos washed off cattle when they wade into
      surface waters. These studies evaluate variables such as concentration of active
      ingredient (coumaphos) in different formulations and various drying intervals
      following treatment.

             a.     Environmental Chemistry, Fate and Transport

                    (1)    Hydrolysis

                          Hydrolysis is  not  a significant  route of dissipation for
                    coumaphos.  The single study available does not by itself satisfy
                    the data requirements,  however, it does provides  supplemental
                    information. That information, along with information from the
                    aerobic  soil metabolism  and  aqueous photolysis  studies,  is
                    sufficient for a qualitative assessment.  Therefore, a replacement
                    study will not be required.

                          Coumaphos degraded with  a half-life of over 30 days in
                    sterile aqueous buffered solution adjusted to pH 5,  7 and 9 and
                    incubated in the dark for 30 days. At 30-Days post-treatment,
                    coumaphos comprised 95.1% of the applied radioactivity recovered
                    from the pH 5 solution, 93.4%  of the  recovered from the pH 7
                    solution and 84.2% of the recovered from the pH 9 solution.  The
                    half-life for coumaphos at pH 9 is estimated to be  ca. 123 days.
                    Three degradates were identified: chlorferon (maximum of 4.3% in
                    all three solutions), the oxygen analog (maximum of 5.0, 1.4 and
                    0.9%, respectively in the pH 5, 7 and 9 solutions) and  6-hydroxy-3-
                    methylbenzofuran (maximum of 0.7, 2.6 and 11.5%, respectively
                    in the pH 5, 7 and 9 solutions).
                                   34

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       The study is not completely acceptable because the actual
pH values tested in the study tended to converge towards a pH of
7, so that too narrow a range of actual pH was actually tested (6.1  -
8.4).  Data supplied by the registrant from a previous hydrolysis
study indicates that coumaphos is most stable at pH 7 and is less
stable  under  acidic  and  basic conditions.   In  this study,  the
tendency  of the pH of the solutions towards pH 7 may have
increased  the  observed  stability  of the compound.   (MRID
00150197,00159928)

(2)    Photodegradation in water

       Coumaphos photodegrades in water with a half-life of ca.
33  hours  when  exposed  to natural  sunlight.   The major
photodegradate representing 43% of the radioactivity after 83.5
hours   of    exposure   was      O,O-diethyl-O-(3-acetoxy)
phenylphosphorothioate.  Besides the parent compound and  the
major degradate there were two other major degradates, i.e. each
representing more than 10% of the applied radioactivity, after 83.5
hours.  Coumaphoxon was identified as the analyte representing
10.2% of applied radioactivity. The other degradate, representing
11.7% was not identified.  The second peak eluted early — nearly
with the void volume — and could have been composed of more
than one  very polar component.  A number of other minor
photoproducts were detected which peaked at 10% and declined
over the course of the study.

       The study is not completely acceptable because a degradate
at  a concentration of 0.06 ppm (11.7% of the applied TRR, after
83.5 hours) was not identified.  To fulfill the data requirement,  the
registrant must identify this degradate. (MRID 42764101)

(3)    Aerobic soil metabolism

       Two different studies indicate that aerobic metabolism is  not
a significant route of dissipation  for coumaphos in soil. In one
study,  coumaphos degraded in a sandy loam soil with a half-life
apparently much longer than 1 year when incubated in the dark for
a year.  One year after treatment coumaphos accounted for 80.4%
of the total radioactivity and unextractable radioactivity accounted
for 13.4% of the total recovered radioactivity.  Four organosoluble
compounds were identified: chlorferon (maximum of 6.2% at 6
months), the coumaphos oxygen analog (maximum of 0.1-0.2%),
               35

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3-methyl-6-hydroxybenzofuran (maximum of 4.1% at 3 months)
and  6-hydroxyl-3-methylbenzofuran (maximum of 0.1% at 9
months).  This study is considered supplemental because up to 0.09
mg/1 of the organosoluble radioactivity was not identified.   To
fulfill the data requirement,  the  registrant  must identify the
uncharacterized degradates.

      In the other available study, coumaphos degraded with a
half-life of 318 days.  Three degradates were identified: chlorferon
(maximum of 13.3% of the recovered), coumaphos oxygen analog
(maximum of 1.4% at 60 days) and 3-methyl-6-hydroxybenzofuran
(maximum of 3.6% at 180 days).   This study was found to be
unacceptable because the  material balances were variable,  and
because the study terminated  at 180 days, before the pattern of
degradation of parent and the formation and decline of degradates
were adequately defined.  (MRID 00115165, 40518701)

(4)    Leaching, Adsorption, and Desorption

      The available information from an acceptable study and a
supplemental study indicates that  aged coumaphos is  relatively
immobile  in  soil.   Information  on the mobility of  unaged
coumaphos in soil is not available  from these studies. However,
these data will not be required at this time since laboratory data
indicate that coumaphos is stable to hydrolysis and aerobic soil
metabolism. Aged column leaching studies also provide data that
shows  coumaphos does  not  degrade  rapidly.  Therefore,  no
additional information  is needed  on  the  mobility of  unaged
coumaphos at this time.

      In an acceptable study,  coumaphos aged 30 days  was
relatively immobile in a column of sandy loam soil leached  with 20
inches of water.  After leaching, the upper 6 cm of the sandy loam
soil column contained 97.93% of  the recovered residues, 1.2%
occurred at depths 6 to 12 cm,  0.04% occurred at depths 12 to 24
cm, and the leachate contained 0.4%.  The radioactivity recovered
in the  upper  6 cm  of the soil  was characterized as 95.8%
coumaphos, 3.1% chlorferon, and 0.9% unidentified organosoluble
residues.

      In a second study, which was not completely acceptable,
aged coumaphos was found to be relatively immobile on sand, silt
loam, and silty  clay loam soils.  After leaching, the upper  6 cm of
               36

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the three columns contained 95 to 97.5% of the radioactivity, while
the leachate contained only 1 to 2% of the total radioactivity.  The
radioactivity  in the upper 6 cm was identified to be primarily
coumaphos, i.e., 77.5% of the recovered radioactivity in the silt
loam soil was coumaphos;  95.25% was coumaphos in the sand  soil.
The major degradate, chlorferon, was 20.8% of the recovered in the
silt loam,  8.0% in the silty clay loam, and 6.7% in the sand  soil.
The  coumaphos oxygen analog was  up to  1.4% of the total
recovered residue, while unidentified residues ranged from 0.3 to
3.6%. The material balances after leaching ranged from  70 to 89%.
For this study to be acceptable the registrant needs to characterize
the aged residues before leaching and to provide adequate material
balances.  (MRID 00163806)

(5)   Terrestrial field dissipation

      The terrestrial field dissipation studies submitted, although
not completely acceptable, indicate that coumaphos is relatively
persistent, as was also indicated by the aerobic soil metabolism
study.

      Coumaphos was applied at 300 mg/1 to two field  plots.  One
plot was tilled to a depth of 6 inches after treatment, while the other
plot was left undisturbed. The tilled plot study was a supplemental
study,  i.e.,  not  completely  acceptable.   This study was not
completely acceptable primarily because the soil was not sampled
to a sufficient depth to define the extent of leaching. Additionally,
the soil  was not analyzed for all major coumaphos residues, and
data   were    not   provided   concerning   the    stability   of
parent/degradates during frozen storage.  The study does indicate
that coumaphos dissipated  with a half-life of 185 days in the upper
6  inches  of  the  soil.  At  depths to  6  inches  coumaphos
concentration decreased  from 294 mg/1 at  1 week following
treatment, to 80 mg/1 at 52  weeks.  At depths of 6 to 12  inches (the
deepest layer analyzed), coumaphos concentration was 25 mg/1 at
32 weeks and 5 mg/1 at 52 weeks.

      The untilled plot study was also found to be unacceptable.
The half-life estimate was 118 days for the upper 6 inches of soil.
At depths to 6 inches, estimated coumaphos concentrations were
343 mg/1  1 week following treatment,  549 mg/1 at 4 weeks, 254
mg/1 at 16 weeks, 375 mg/1 at 32 weeks,  and 69 mg/1 at 52 weeks.
At depths  of 6 to 12 inches  (the  deepest layer  analyzed),
               37

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coumaphos concentration was 83 mg/1 at 32 weeks and 49 mg/1 at
52 weeks.  The study was not acceptable primarily because the data
were highly variable, the soil was not sampled at sufficient depth
to define the extent of leaching, the soil was not analyzed for all
major coumaphos residues, and no data were provided on stability
in frozen storage.  (MRID 00115166)

(6)    Special retrospective field dissipation study

       The information provided by a single study indicates that
coumaphos will leach to the subsurface (66-72 inches depth) when
disposed of in unlined pits.  Ground water contamination could
result where ground water is close to the surface.

       The Agency required that this study be  conducted to
evaluate retrospectively six major use areas in the continental U.S.,
including at least  one site involving a sandy soil over a shallow
water table. The registrant submitted one study performed in Texas
at eight locations, which evaluated the depth of leaching in disposal
pits and walkways of coumaphos treatment  dip vats.   (Not  a
guideline study, No MRID has been assigned)

(7)    Bioaccumulation in fish

       The information provided by a supplemental study suggests
that coumaphos will not be significantly biomagnified in aquatic
food chains.

       Two studies were reviewed.  Only one was found to provide
useful information on bioaccumulation.  In the study found to be
supplemental,  total coumaphos accumulated in bluegill sunfish
with a maximum bioconcentration factor  of 541 in whole fish
during 30 days of exposure at 10 |ig/l, in a flow-through aquatic
system.   In both edible  and nonedible  tissues,  33% of the
extractable radioactivity was coumaphos, while 63-68% remained
at the origin.  In general, accumulated coumaphos residues were
depurated rapidly, with 98% elimination after 1 day in untreated
water.  This study is not acceptable primarily because the analytical
methods may not  have been adequate to identify the majority of
coumaphos residues extracted  from fish  tissues,  the  material
balance was not  complete, and residues in the water were not
characterized.
               38

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             In the  unacceptable  study  high  mortality  precluded
       estimation of accumulation and depuration of coumaphos: 42 out
       of 80 fish died during the 30 days of the study. (Cause of death was
       not reported but is probably due to coumaphos exposure.) (MRIDs:
       00115168, 00115169, 00150619)

b.     Environmental Fate Assessment

       The various degradation, metabolism, mobility, dissipation and
ground water studies discussed above,  although found  mostly to  be
supplemental,  do nevertheless support a qualitative characterization of the
properties of  coumaphos in the environment.  Based upon a review of
studies submitted, coumaphos is persistent in the environment, with the
exception that aqueous photolysis is rapid (half-life 33 hours).  The half-
life is much greater than 30  days for hydrolysis; much greater than a year
for aerobic soil metabolism; and ca. 118 to 185 days for field dissipation.
Coumaphos also appears to  be immobile, with Kd values ranging from  61
to 298  for parent and from 91 to  161  for the degradate chlorferon.
Coumaphos accounted for 0.4% of leachate from a sandy loam column and
less than 2%  of leachate from columns of sand, silt loam, and silty clay
loam.

       The major degradates identified under aerobic conditions were
chlorferon, which reached a maximum of 6.2%  of the organosoluble
radioactivity recovered  at six months, and 6-hydroxyl-3-methylbenzofuran,
the oxygen analog, which  comprised a maximum  of 0.2% of recovered
radioactivity at six months.  In column leaching studies, chlorferon and 6-
hydroxyl-3-methylbenzofuran comprised 3.1% and  0.2%, respectively, in
the top six inches of the sandy loam soil column.  Similar results were
obtained in the three other  soil columns (using sand, silt loam,  and silty-
clay loam.)

       In two field dissipation  studies, the half-life for coumaphos was
estimated at 118 and 185 days.  Coumaphos was applied at 300 mg/1 with
and without incorporation. The soil was not sampled at sufficient depth to
define the extent of leaching; however, samples taken 6 to 12 inches deep
contained coumaphos at concentrations of 25 to 375 mg/1 32 weeks after
treatment and at 5 to 69 mg/1 52 weeks after treatment.

       A special retrospective  field dissipation study was conducted to
characterize the depth of leaching  in disposal pits  and walkways  of
coumaphos treatment dip vats.  On-site disposal of spent coumaphos in
unlined pits was found to result in leaching of coumaphos, chlorferon and
                      39

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       potasan to the subsurface (72 inches in the study), and could result in
       ground-water contamination in areas of shallow ground water.  These
       compounds may reach ground water, although there was insufficient depth
       of soil sampling conducted in the study to determine if coumaphos and/or
       its metabolites could have reached the deep wells that were tested during
       the study.

             Results of the special field dissipation study support the finding that
       coumaphos is persistent; however coumaphos moved to greater depths
       than expected based on it's Kd values. The apparently higher mobility in
       the  special  dissipation  study could  have  resulted from the  high
       concentration of spent coumaphos in soil evaporation pits. (See also EPA,
       1980, 600/2-80-124).

2.     Ecological Effects

       Coumaphos is highly to very highly acutely toxic to birds if consumed,
based on terrestrial vertebrate test data. Available measurements of avian acute
oral  LD50, for coumaphos  TGAI, ranged from 2.4  to 29.8 mg/kg based on
bobwhite quail, mallard duck and pheasant. Available measurements of the avian
dietary LC50, using TGAI coumaphos as the test material, ranged  from 82.1 to
401.9 mg/kg based on tests including:  bobwhite quail, mallard duck, ring-necked
pheasant and Japanese quail.  For terrestrial mammals, a wide range of LD50
values have been obtained based on testing using rats that indicate slight to high
toxicity on an acute oral basis: LD50 values were as low as  17 mg/kg for the TGAI,
and as  low as 32 mg/kg for an end-use product.

       Data for aquatic organisms indicate that coumaphos is moderately to highly
toxic to fish on an acute basis: LC50 measurements for coumaphos TGAI ranged
from 0.34 mg/kg for bluegill sunfish to 5.9 mg/kg for rainbow trout.  Coumaphos
can be characterized as very highly  toxic to aquatic  invertebrates on an acute
basis: LC50 values for coumaphos TGAI ranged from  0.074 //g/1 for Gammarus
lacustris to 0.224 //g/1 for Gammarus fasciatus.

       Chronic toxicity data are  available for aquatic animals. Data from a fish
early life stage study with coumaphos showed that for Rainbow trout, based on the
most sensitive parameters, length and weight, the NOEC, LOEC and MATC are
11.7 //g/1, 24.6 //g/1 and 16.9 //g/1, respectively. Data from a Daphnia magna life
cycle chronic toxicity study with  coumaphos showed  that based  on the  most
sensitive parameter, survival, the NOEC, LOEC and MATC are 33.7 ng/1, 75.8
ng/1  and 50.5 ng/1, respectively.  (The concentrations  here represent  average
measured values.)
                            40

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       Data on marine and estuarine animals indicate that coumaphos is highly
toxic to marine and estuarine fish. The LC50 for sheepshead minnow is 280 //g/1.
Coumaphos is also highly toxic to marine and estuarine mollusks on an acute
basis. The LC50 measurements for marine and estuarine mollusks ranged from 290
//g/1 to 880 //g/1 based on the oyster Crassostrea virginica. Coumaphos is very
highly toxic to  marine crustaceans on an acute basis.  The available LC50
measurement was 2.0 //g/1.

       Data requirements for non-target insects and plants are not applicable for
coumaphos, due to the limited use pattern of the chemical.

       a.     Ecological Effects Data

             (1)    Terrestrial Data

                    To evaluate the toxicity of a pesticide to birds, the following
             tests are required using the TGAI material:

             •      An  avian single-dose  oral (LD50) study on one  species,
                    preferably mallard or bobwhite quail;

             •      A  subacute  dietary (LC50) study  using  one  waterfowl
                    species, preferably the mallard duck;

             •      A subacute dietary (LC50) study using one upland game
                    species, preferably bobwhite quail or ring-necked pheasant.

                    Tests on wild mammals may be required, depending on
             intended use pattern, environmental fate characteristics, or based on
             the results of lower tier studies such as acute/sub acute toxicity tests.
             These data are not required for coumaphos due to it's limited use
             pattern.

                    An  acute contact LD50 for honey bees is required if the
             proposed use will result in exposure to honey bees.
                             41

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                    (a)    Avian Acute Oral Toxicity

                          The data requirement is fulfilled based on studies
                    available.   Ten studies were evaluated, and  all were
                    determined to be acceptable for use in this risk assessment.
                    There are sufficient  data to  characterize coumaphos as
                    highly to  very highly toxic  to birds on an acute oral
                    basis. Available toxicity measurements are summarized in
                    the table below.
Avian Acute Oral Toxicity
Species
Bobwhite quail
Mallard duck
Pheasant
Test Material (% AI)
98.25%
95%
95%
LD50
mg/kg
2.4
29.8
7.94
(MRIDs: 112841, 160000)
                    (b)    Avian Subacute Dietary Toxicity

                          There are sufficient data to characterize coumaphos
                    as highly toxic to birds on a dietary basis.  Available
                    toxicity data are summarized in the table below.
Avian Subacute Dietary Toxicity
Species
Bobwhite quail
Mallard duck
Ring-necked
Pheasant
Japanese quail
Test Material
(% AI)
98.25%
95%
98.25%
95%
95%
95%
LC50
ppm
82.1
120
401.9
709
318
225
(MRIDs: 112842,022923, 112843)
                             42

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             Until recently the Agency would have required a
      Level 1 terrestrial field study to evaluate the risk to birds.
      A pilot field study has actually been conducted.  That study
      was classified as supplemental; however, it is scientifically
      sound and  provides  information  concerning potential
      exposure pathways to birds, as described in greater detail
      later under Acute Avian Risk. (MRID: 42512604)

      (c)    Avian Reproductive Toxicity

             Avian reproduction studies will not be required
      for coumaphos at this time. Such studies may be required
      when birds are likely to be exposed to a pesticide repeatedly
      or continuously.  The assessment of acute risk (§A.2.b)
      indicates  that if there were significant exposure to birds,
      they would be killed before chronic effects can occur.

(2)    Aquatic Data

      (a)    Freshwater Fish Toxicity

             To evaluate toxicity  to  freshwater  fish,  LC50
      measurements are required for two species using TGAI.
      One  study should use a  coldwater  species,  preferably
      rainbow trout,  and  the other should  use  a warmwater
      species, preferably bluegill sunfish.

             Nine studies in three documents were evaluated
      under this topic, and all studies were acceptable for use in
      a risk assessment. Toxicity measurements are summarized
      in the following table.
               43

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Acute Toxicity to Fish (72-1 a,c)
Species
Bluegill sunfish
Rainbow trout
Lake trout
Cutthroat trout
Largemouth bass
Walleye
Test Material
(% AI)
99.6%
95%
99.6%
95%
95%
95%
95%
95%
-L'^'50
(mg/1)
5.0
0.34
5.9
0.89
0.593
0.862
1.1
0.780
(MRIDs: 112840,40098001, 112840)
                          Coumaphos is moderately to highly toxic to both
                   warmwater and coldwater fishes

                          A fish early life stage study has been received and
                   reviewed. The following results were obtained.
Fish Early Life Stage Study [72-4(a)]
Species
Rainbow trout
Test Material
(% AI)
99.2%
Toxicity
GiR/1)
NOEC= 11.7
LOEC = 24.6
MATC = 16.9
(MRID: 43066301)
                    (b)    Toxicity to Freshwater Invertebrates

                          To   evaluate  toxicity  to  freshwater  aquatic
                    invertebrates, an LC50 measurement is required, preferably
                    using  first  instar  Daphnia  magna,   or   early-instar
                    amphipods, stone-flies, mayflies, or midges.  LC50 values
                    are displayed in the table below.
                            44

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                            Five studies were evaluated under this topic. These
                    studies  were  deemed   acceptable  for use  in a  risk
                    assessment.  There is sufficient information to characterize
                    coumaphos  as very highly toxic to freshwater aquatic
                    invertebrates.  The following toxicity measurements are
                    available.
Acute Toxicity to Aquatic Invertebrates [72-2(a)]
Species
Gammarus lacustris
Daphnia magna
Test Material
(% AI)
95%
98.9%
97.0%
98.9%
LCso
GiR/1)
0.074
0.224
0.14
0.192
(MRIDs: 40098001, 41778503, 41778504, 05009242)
                           An aquatic invertebrate life cycle test was submitted
                    and reviewed. The following results were obtained.
Aquatic Invertebrate Life-Cycle Study [72-4(b)J
Species
Daphnia magna
Test Material
(% AI)
99.1%
Toxicity
(ng/1)
LOEC = 33.7
NOEC = 75.8
MATC = 50.5
(MRID:43116601)
                    (c)     Acute Toxicity to Estuarine and Marine Animals

                           Data on  acute  toxicity to estuarine  and marine
                    organisms are required to support the registration of end use
                    products intended for direct application to the estuarine or
                    marine environment or if the product is expected to enter
                    this environment in significant concentrations because of its
                    expected use or mobility pattern.  Because the current uses
                    of coumaphos do not meet these criteria,  no estuarine and
                    marine toxicity studies are  required.   The  following
                    measurements are  available,  from  four studies in one
                    literature source.    There  is sufficient information  to
                             45

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             characterize coumaphos as highly toxic to marine fish and
             very  highly toxic to marine invertebrates.   (MRID
             40228401)
Acute Toxicity to Estuarine and Marine Invertebrates
(72-3)
Species

Cyprinodon variegatus
Test Material
(% AI)
Fish [72-3(a)]
95%
Toxicity
GiR/1)

LC50 = 280
Mollusk [72-3(b)]
Crassostrea virginica
95%
95%
EC50 = 880
EC50 = 290
Crustacean [72-3(c)]
Penaeus duorarum
95%
EC50 = 2.0
       (3)    Non-Target Insects Data

             Data requirements for non-target insects testing are  not
       applicable for the coumaphos use patterns, and no studies were
       required or submitted.

       (4)    Non-Target Plants Data

             Data requirements for non-target plant testing  are  not
       applicable for the coumaphos use patterns, and no studies were
       required or submitted.

b.     Ecological Effects Risk Assessment

       The Agency has evaluated the risks to terrestrial and aquatic non-
target organisms resulting from treatment of cattle for control of arthropod
pests.  Coumaphos is applied to cattle primarily by dip vats, whole body
sprays, back rubbers and dust bags.

       In order to assess exposure to nontarget organisms, it is necessary
to have information on the concentration  of active ingredient on the hides
of treated cattle, and information on the potential of coumaphos to wash
                      46

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off into water when cattle wade into bodies of water. The registrant has
submitted two studies that address these issues. Those studies have been
reviewed and found to  be acceptable  for use  in a risk  assessment.
Information from those studies is incorporated in risk assessments for both
terrestrial and aquatic nontarget organisms.  Additional information for
exposure assessment was  obtained by personal communications from the
U.S. Hide, Skin and Leather Association (USHSLA). (MRIDs: 42512601,
42512602).

       (1)    Risk to Terrestrial Animals

             Risk to nontarget terrestrial animals is expected to result
       primarily from direct treatment of livestock. Use of coumaphos to
       treat livestock bedding is not expected to result in significant risk
       to terrestrial wildlife, because that is primarily  an indoor use,
       associated with minimal exposure to terrestrial wildlife.

             (a)    Avian Acute Risk

             Coumaphos is very highly toxic to birds on an acute oral
       basis, based on LD50 estimates as low as 2.4 mg/kg. Birds may be
       subject to primary exposure (ingestion of hair and skin debris from
       treated cattle) or secondary exposure (ingestion of birds killed by
       the pesticide, and contaminated with pesticide.)

             Apart from the values of risk quotients (described in detail
       below),  there is  evidence that  birds are at risk  under field
       conditions, as  a  result of  the  cattle treatment use of other
       organophosphate insecticides.  Studies in peer-reviewed scientific
       literature indicate that treatment of cattle with pesticides (none were
       coumaphos) has resulted in mortality in a variety  of bird species,
       primarily the black-billed magpie Pica pica (Henny et al., 01985;
       Henny et al., 1987; Felton  et al.,  1981).  That literature  also
       indicates a potential  for secondary poisoning of birds.

             A pilot field  study submitted to the Agency confirms that
       birds may be exposed to coumaphos by direct contact with treated
       cattle,  exposure to  cattle hair, and/or by exposure to contaminated
       soil and feed in and around treatment areas.  Eight cattle in one pen
       were sprayed with coumaphos (2 Ib ai in 50 gal water) until each
       individual was thoroughly soaked.  After treatment, coumaphos
       residues were detected in soil samples (4.35-635 ppm, w=40), cow
       feces (<0.01-0.53 ppm, «=32), cow hair samples (<0.1-1450 ppm,
                      47

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w=32),  and stomach contents (<0.003-0.901  ppm,  w=17)  of
cowbirds.  Brain cholinesterase activity was inhibited 2-59% in 13
of 19 cowbirds examined.  Thirty-four bird species were recorded
within 200 m of the treatment site, with six species observed on the
ground in the pen.  Based on several counts, 290 birds were
estimated to frequent the 3.7-hectare pen. The results from treating
only 8 cows in one pen are too limited in scope to draw  any major
conclusions.  The  study  did indicate that a variety of birds are
likely to be present at treatment sites and that they may be exposed
to coumaphos residues from soil, cattle feces, and cattle hair.  That
study also includes information regarding bird use of feedlots and
pastures, and species likely to be exposed, ranked in order of
potential exposure  in feedlots.  The black-billed magpie, because
of its close association with cattle, was listed as the species most
likely to be exposed.  The pilot field study,  and the  literature
sources cited previously, indicate that many bird  species utilize
pastures or feedlots.  (MRID: 42512604)

       The Agency has a report of an incident in which a bald
eagle was  found dead as a result of coumaphos poisoning.  The
exact mechanism of exposure is unknown for that incident.

       The Agency  has determined that  the  cattle use  of
coumaphos could pose high risk to birds feeding from the surfaces
of treated cattle.  That  conclusion  is based  on  the  following
calculations, which appropriately adapt standard risk assessment
procedure to this context. As an index of risk, the risk quotient
(RQ)  is calculated from exposure and toxicity data.   The RQ
formula compares the quantity of active ingredient on a square foot
of cow hide to the LD50, i.e., to the quantity expected to cause 50%
mortality when ingested.  The RQ is calculated according to the
following formula:

     Mass coumaphos a.i. per sq.ft.
        LD50 x Bird Body Weight

       Appropriate units for  the RQ calculation are mass  of
coumaphos in mg, LD50 in mg/kg, and body weight in kg. RQ
values 0.5 or larger are taken to indicate high risk, values 0.2 or
larger are taken to indicate concerns for restricted  use pesticides,
and values 0.1 or larger indicate concerns for endangered species.
(The values 0.5, 0.2, and 0.1 denote the levels  of concern or
LOCs.)
               48

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                      RQs (displayed in the table following) were calculated based on
               the following assumptions.  The assumed body weight is 0.1775  kg, which
               is an average weight for the black-billed magpie.  Toxicity measurements
               are unavailable for that species.  Based on available measurements of
               toxicity to birds, the appropriate LD50 value is 2.4 mg/kg.  Mass of
               coumaphos per  square  foot of cow hide was determined  based on
               information from labels, information from the U.S. Hide, Skin and Leather
               Association (USHSLA), and the two submitted studies, cited previously.
               The mass of coumaphos per square foot (displayed with RQ values in the
               table  following)  depends on  the  method of application  and  on the
               formulation used.  Calculated RQ values substantially exceed high risk
               levels of concern.
Risk Quotient (RQ) values for birds. The finding of high risk is supported by RQ values that
substantially exceed 0.5, which is the high risk level of concern (LOG).
Formulation
5% Dust
1 1.6% Emulsifiable Powder
25% Wettable Powder
Example: For the 5% Dust formulatio
RO - 11° 7
Coumaphos
mass a.i.
per sq.ft.
cow hide
48 mg
179.3 mg
249. 6 mg
Risk Quotient
(RQ)
113
429
586
D (row 1),
48 mg
2.4 mg/kg x 0.1775 kg
                            (b)    Avian Chronic Risk

                                   Avian chronic effects have not been characterized.
                            Assessment  of chronic effects could be  required  for
                            registration of new uses, rates or methods of application.
                                     49

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       (c)    Mammalian Acute Risk

             Coumaphos is not expected to pose a risk to non-
       target endangered or non-endangered mammals because the
       limited use pattern of coumaphos, i.e., treatment of cattle in
       confined areas, is  not  expected  to result in significant
       exposure.

(2)    Risk to Aquatic Animals

       Coumaphos is toxic to all types of aquatic animals that have
been tested. There will be some exposure of aquatic organisms if
treated cattle  enter bodies of water. Cattle enter bodies of water,
particularly in summer, for relief from heat and flies.  This risk
assessment is  based  on  certain assumptions  including the
concentration of coumaphos on a cow's skin, fraction of a cow's
skin surface that is submerged (25% assumed), and fraction of
coumaphos on submerged skin that becomes available for exposure
to aquatic organisms.  It is also assumed that cattle wade into a
body of water  with surface area 1  acre and depth 6 feet. Results of
the analysis (with assumptions described in detail in a subsequent
section) indicate a high acute risk to aquatic invertebrates, but
do not indicate high chronic or acute risk for endangered or non-
endangered fish.

Quantification of washoff.  When treated cattle enter water, some
fraction of the coumaphos on their skins, here denoted as washoff,
dissolves in the water. Studies of washoff have been submitted and
determined to be acceptable for use in risk assessment.

       Washoff appears to depend on the coumaphos formulation
and on the time that a cow's skin is permitted to dry before the
animal enters water (see table  below).  In the washoff  studies
submitted, fresh cow hides were treated with different coumaphos
formulations,  then dried for 0.5, 3, or 24 hours.  Washoff was
measured after hides had been soaked in water for 0.5, 1.0, 2.0 or
4.0 hours. For  one of the two studies submitted, the coumaphos
formulation was Co-Ral® 11.6% emulsifiable  liquid;  the  other
study used Co-Ral® 25% wettable powder. The longer the drying
time,  the  lower  the  washoff.   Washoff is also affected by
formulation,  however, after 24 hrs of  drying there was little
difference between  the different formulations.   There was no
               50

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                           statistically significant effect of soaking time. The following table
                           relates washoff to formulation and drying time.
                   Percent Washoff for Different Formulations of Coumaphos
                                at Different Drying Intervals
Formulation
1 1.6 % Emulsifiable Liquid
25% Wettable Powder
Drying Times (his)
0.5
11.6%
38%
o
J
4.6%
21%
24
2.7%
2.0%
       (MRIDs: 42512601, 42512602)
Estimated Environmental Concentrations and Risk Quotients for Aquatic Organisms.

       The quantities displayed in the following table have been calculated based on following
assumptions:

       •      EEC/cowis the estimated concentration in a body of water (1  acre surface, depth
             6 feet) if a single treated cow wades into it.

       •      RQ/cow is the risk quotient for organisms in a body of water, if a single treated
             cow wades into the body of water.

       •      cows/LOC is the  number of treated cattle that will cause the level of concern
             (LOG) in a body of water to be exceeded, if that number of treated cattle wade into
             the body of water.

These quantities are calculated as follows:
       EEC/cow
surface area of cow in sq. ft.

jig coumaphos per sq.ft. hide

fraction of cow surface submerged in a body of water containing
nontarget organisms

fraction washoff (term defined above)

2.205 x  10-9lb/|ig

61 jig/1 concentration in pond per Ib loading.

                51

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      RQ/cow     = (EEC/cow) / LC
                                    50
       cows/LOC   = LOG / (RQ/cow) -->      express as an integer, round up to the nearest
                                             whole number.

                   (NOTE:  cows/LOC is the number of cows needed to exceed the LOG.)

The numerical inputs for these expressions are:

•      The surface area of a 1000-2000 Ib. cow is about 45 sq.ft., based on communication from
       Jerry Breiter of the U.S. Hide and Leather Association.

•      jig coumaphos per sq.ft. hide  1793 x 102 for the 11.6% emulsifiable liquid formulation;
       2496 x io2 for the 25% wettable power formulation (as displayed above for the terrestrial
       risk assessment).

•      A cow will generally enter water up to the hair break line, which is a clearly visible line
       on the sides of the cow, where the types of hair change visibly.  According to the
       USHSLA, this means that about 25% of the skin surface is submerged.

•      Fraction washoff is specific to formulation and drying time as displayed above, e.g., 0.116
       for the 11.6% emulsifiable liquid formulation with 0.5 hr. drying.

•      LC50 = 0.074 |ig/l for invertebrates; LC50 = 340 |ig/l for fish.

•      LOG is a critical risk quotient value for determination of concerns:  LOG = 0.5 for high
       risk, 0.1 for restricted use, or 0.05 for endangered species.


Example.  The values in row 1 of the table following are calculated as follows.

       EEC/cow    =45 x 179300 x 0.25 x 0.116 x 2.2 x 61 / IO9

                   = 0.0314 |ig/l.

       RQ/cow      =0.0314/0.074 = 0.424

       cows/LOC   = 0.424 / 0.5 = 1.2, i.e., 2 cows are just enough.
      When these quantities are calculated for fish, the result is that over 100 cows must wade
into a 1 acre body of water in order for the LOG to be exceeded for endangered species; over
1000 cows must enter in order for the acute high risk LOG to be exceeded.  This suggests that the
                                         52

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coumaphos cattle use does not pose a threat to endangered or non-endangered fish species on an
acute basis.

       Coumaphos  does not pose a risk to fish on a chronic basis.  The  chronic LOG is
EEC/MATC equal to 1 or larger for endangered or non-endangered species.  The fish chronic
MATC is 16.9 |ig/l based on a measurement with rainbow trout. For that concentration to be
achieved, over 100 cows would have to wade into the 1 acre body of water. Additionally, the
short half-life of coumaphos in water (33 hours, photolytic) indicate that chronic exposure will
not be a problem.

       For aquatic invertebrates, the calculations are displayed in full below,  and indicate that
a small number (1 to 6) of treated cattle wading into a body of water would cause the high risk
LOG (acute) to be exceeded. Also, coumaphos is sufficiently toxic on an chronic basis that a
single  treated cow wading into the body of water could cause high risk to invertebrates on a
chronic basis.
                                         53

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LOC
Formulation
11.6%Emulsifiable
Liquid


25% Wettable
Powder


determination for Aquatic Invertebrates (Acute risk)
(based on LC50 = 0.074 |ig/l)
Drying Time EEC/cow RQ/cow
(hours) (ng/1)
0.5 0.031 0.42
3.0 0.012 0.17
24.0 0.0073 0.099
0.5 0.14 1.9
3.0 0.076 1.0
24.0 0.0073 0.098

cows/LOCa
(HR)b 2
(RU)C 1
(ES)d 1
(HR)3
(RU)1
(ES)1
(HR)6
(RU)2
(ES)1
(HR)1
(RU)1
(ES)1
(HR)1
(RU)1
(HR)6
(RU)2
(ES)1
aNumber of wading cattle necessary to exceed the LOC
bcows/LOC for high risk LOC
°cows/LOC for restricted use LOC
dcows/LOC for endangered species LOC
                             (3)    Risk to Plants
                                    A characterization of risk to plants (terrestrial, aquatic, or
                             semi-aquatic) is not required for coumaphos due to its limited use
                             pattern.
                                              54

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IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.    Determination of Eligibility

             Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
       of relevant data concerning an active ingredient, whether products containing the active
       ingredient are eligible for reregi strati on.  The Agency has previously identified and
       required the  submission of  generic  (i.e.  active ingredient specific)  data  to support
       reregi strati on of products containing coumaphos as an active ingredient.  Handler
       exposure data (mixer/loader/applicators) were not required by either the 1981 or 1989
       Registration Standards.  The Agency stated in the  1989 Registration Standard-Second
       Round Review that:  "... the  need for this data would be reassessed upon receipt and
       review of the required toxicology data." The Agency has completed its review of the
       toxicological database, and has determined that handler/occupational exposure data are
       required. The Agency has 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.  In addition,
       the Agency made extensive use of the Pesticide Handlers Exposure Database (PHED) for
       occupational exposure estimates, i.e., mixer/loader/applicators. Use and economic benefit
       information for coumaphos provided by the registrant, State Agricultural Program Reports
       and from the USDA  were also considered, especially economic benefit estimates for
       USDA's quarantine use of coumaphos. The  Agency also considered the fact that the
       Department of Agriculture, Animal & Plant Health Inspection Service has an on-going
       program to monitor cholinesterase levels in handlers involved in treating animals with
       coumaphos.

             Appendix B identifies the generic data requirements that the Agency reviewed as
       part of its determination of reregistration eligibility of coumaphos, and lists the submitted
       studies that the Agency found acceptable.
             1.     Eligibility Decision

                    The Agency has determined that coumaphos products, labeled and used as
             specified in this Reregistration Eligibility Decision, may pose adverse effects to
             humans, aquatic invertebrates and birds.  The Agency has concerns with low
             MOEs for mixer/loader/applicators, with the proper disposal of the spent cattle dip
             vat solutions, and with the acute toxicity of coumaphos to aquatic invertebrates
             and birds.

                    The Agency defers making a regulatory decision on non-USDA uses of
             coumaphos until chemical-specific handler exposure studies are submitted (see
             Section V).  The Agency can make a regulatory decision concerning the USDA
                                          55

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uses of coumaphos because of the very significant economic benefits, the lack of
an acceptable alternative, and the fact that USDA has a program in place to
monitor the cholinesterase levels of the handlers involved. In the USDA Import
program livestock are treated with coumaphos to control  ticks and prevent
outbreaks of Texas Cattle Fever (also known as Southern Fever). Coumaphos is
also used in a quarantine  mode. Together these uses account for almost half of
coumaphos usage  in  the U.S.  Despite uncertainties  in the existing handler
exposure databases, the Agency finds that MOEs for large dip vat and hand-held
sprayer treatment of large herds are very low. Therefore, the Agency is requiring
closed systems for the mixing/loading of coumaphos products used in dip vats
and/or hand-held sprayers, i.e., water-soluble bags for the WP formulation. The
registrant must determine an appropriate system to reduce handler exposure during
mixing/loading for the flowable and emulsifiable concentrate formulations. The
appropriate system to reduce handler exposure during mixing/loading may be gel
packs, "no glug" containers or any other  equivalent system approved by the
Agency.  Appropriate systems to reduce handler exposure must be addressed in
the eight-month  required  response.  The registrant must propose a system and
submit handler exposure studies to document handler exposure and confirm that
improved packaging/closed system now results in acceptable MOEs (specified in
Part V).  When  the chemical-specific exposure data required by this RED are
received and reviewed, the Agency will make a regulatory decision regarding the
reregi strati on eligibility of the non-USD A uses of coumaphos. The Agency may
reassess the USDA uses of coumaphos if the exposure data required as part of this
RED (considered confirmatory when closed systems are introduced) indicates a
high risk to handlers.

2.    Eligible and Ineligible Uses

      The technical registrant (Bayer) has stated, over a year ago, that they will
voluntarily cancel the pour-on use of coumaphos.  They also state that mechanical
dusting of animals is no longer a common practice and that they are willing to
propose label restrictions  to prohibit such use.  However, until these actions are
actually accomplished, data will be required to support these uses.

      The Agency does  not have chemical-specific data for coumaphos and
preliminary calculations using surrogate data  (PHED)  indicate a potential for
handler exposure and/or risk from coumaphos as it is currently registered. The
Margin of Exposure (MOE) for the dip vat use was calculated to range from 9 to
36 for "topping off"  or refilling the dip vats which is required after animals
moving through the vats have depleted the liquid level.  MOEs  for refilling empty
dip vats (up to 4000 gallons) would be smaller by a factor of four (MOE of 2.5 to
9). These MOEs  are considered to be of concern by the Agency, and normally the
Agency would consider these uses ineligible for reregi strati on due to the potential
                            56

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risk for mixer/loader/applicators.  However, the risks must be  considered in
context with the benefits.  In addition, the Agency is requiring closed systems
and/or improved packaging to reduce exposure during mixing/loading of all
coumaphos end use products registered for use in either dip vats or hand-held
sprayers. The closed system for the WP formulation(s) should be water soluble
bags.   The registrant must determine appropriate systems for the flowable and
emulsifiable concentrate formulations. It could be gel packs, "no glug" containers
or any other equivalent system approved by the Agency. In either case, data must
be submitted that supports the system chosen.

       USD A/APHIS is a major consumer of coumaphos, using almost half of the
total amount sold in the  U.S..   Coumaphos is used in dip vats along the
Texas/Mexico border in a program to eliminate Texas Cattle Fever, carried by
certain species of ticks. USDA has estimated the economic importance of this use
to be between  $1-5 billion dollars.  The Agency  has decided  based on the
economic importance of coumaphos to  the  Texas Cattle Fever eradication
program, that all USDA fever tick uses are considered eligible for reregi strati on
provided the required exposure studies are submitted and closed systems discussed
above are introduced.

       The USDA routinely monitors the cholinesterase activity of its employees
actively involved in the fever tick program (Boophilus spp., Dermacentor nitems.
and exotic ticks). The Agency is in consultation with USD A/APHIS concerning
this program and may request additional safeguards, however,  existence of the
program provides  a "safety net" that enables the Agency to make a regulatory
decision for these uses. Therefore, all USDA uses of coumaphos to treat for Texas
Cattle Fever are  considered eligible for reregi strati on. The Agency is aware that
there  are at least twelve other non-USDA dip vats (located in  CO and TX),
however, when there are quarantine or tick problems the USD A/APHIS  operates
the dip vats for the duration of the quarantine treatment(s).  Therefore, the
cholinesterase levels  of the handlers (mixer/loaders/applicators) involved in
treating the cattle would be monitored by the USDA.  The Agency is requiring in
this RED handler exposure data as outlined in Part V.  If these data, even with
closed systems, indicate low MOEs (i.e., < 100) then the Agency may take further
regulatory action.

       The Agency has conducted exposure assessments for the various uses, i.e.,
different methods of application.  The Agency has calculated handler exposure
and risk estimates based on a handler handling "typical" and "maximum"  amounts
of coumaphos of 0.5 Ib ai  and 5.0 Ib ai/day, respectively, for spray operations.
This corresponds to treating 100 and 1,000 cattle with coumaphos  per day based
on a use rate of 0.5 Ibs ai/100 gallons the minimum use rate.  MOEs for these
exposure scenarios were 82 and 8.2, respectively. However, uncertainties in the
                            57

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existing  handler  exposure  databases  (PHED) do  not allow the Agency to
determine,  with confidence, the exact MOEs for these exposure scenarios.
Therefore, the Agency has determined that a decision concerning the reregi strati on
of non-USDA uses of coumaphos  cannot be made until handler/occupational
exposure data are received and reviewed.

       The Agency does believes the data indicate  a sufficient risk concern to
require closed systems and improved packaging now, rather than delay a decision
for several years until exposure data are conducted, submitted and reviewed.  The
registrant's own calculations report MOEs of 28 for a "topping off" of a large dip
vat and  122 for "maximum spraying".  These MOEs differ from Agency
calculated MOEs because of different assumptions.  However, if these numbers
are corrected to reflect real maximum use rate not minimum rates as reflected in
the registrant's  submission, i.e., 4000 gallon dip vats  (not 1000  gallons) and
maximum spray use rate of 4.0 lbs/100 gallons (not 0.5 Ibs ai/100 gallons) then the
MOEs are 7.0 and 15.2, respectively. Again the registrant's MOEs are slightly
higher from those calculated by the Agency due to less conservative, i.e., less
protective of human health assumptions (see the Occupational Risk Assessment
Section for details).
    SUMMARY OF THE AGENCY'S REREGISTRATION DECISION
Animal
Beef Cattle
USDA
Non-USDA
Dairy cows
USDA
Non-USDA
Sheep
USDA
Non-USDA
Hogs
USDA
Non-USDA
Horses
USDA
Non-USDA
Goats
USDA
Non-USDA
Reregistration
Decision

Yes
No

Yes
No
Yes
No
Yes
No

Yes
No

Yes
No
ChE Monitoring
Program

Yes
No

Yes
No
Yes
No
Yes
No

Yes
No

Yes
No
Handler Data Gaps

Yes
Yes

Yes
Yes
Yes
Yes
Yes
Yes

Yes
Yes

Yes
Yes
                            58

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B.     Regulatory Position

       The following is a summary  of the regulatory  positions and rationales for
coumaphos.  Where labeling revisions are imposed, specific language is set forth in
Section V of this document.

       Coumaphos  is an important tool for the control of Texas Cattle  Fever in the
USDA's Tick Eradication Program.  It is estimated, by USDA, that the cattle industry
would sustain annual losses of $1-5 billion dollars if cattle fever ticks and the associated
disease, babesiosis, were to become re-established in the U.S.. Equine babesiosis could
result in mortality rates of about 10% or greater in susceptible horses.  There are no
available data to estimate economic losses due to the disease if introduced in the horse
population in the U.S..  It should be noted that the international movement of show and
race horses and cattle from the United States would be severely restricted. It should also
be noted that the total use volume of coumaphos is relatively low (when  compared to
insecticides with agricultural uses on crops) and the USDA has a program in place to
monitor worker's cholinesterase levels.  The Agency  is  declaring all USDA uses of
coumaphos to control Texas Cattle Fever eligible for reregi strati on provided the required
exposure data outlined in this RED are submitted and closed systems/improved packaging
to reduce exposure during mixing/loading of dip vat and hand-held sprayer solutions. The
Agency must defer  a decision on the remaining uses of  coumaphos until the handler
exposure data required in this RED are submitted and reviewed.

       1.     Tolerance Reassessment

             The tolerances listed under 40 CFR §180.189 are for the combined residues
       of  coumaphos and its oxygen  analog.   A summary of coumaphos tolerance
       reassessments is presented in the Table below.

             Sufficient data are  available  to  ascertain  the adequacy of established
       tolerances listed in 40 CFR §180.189 for meat, fat, and meat byproducts of cattle,
       goats,  hogs, horses, and sheep, and milk.
             The established tolerances for meat, fat, and meat byproducts of poultry,
       and eggs should be revoked, as the uses  of coumaphos on poultry have been
       voluntarily canceled.
                                   59

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                Tolerance Reassessment Summary
Commodity
Cattle meat
Cattle fat
Cattle meat byproducts
Eggs
Goats meat
Goats fat
Goats meat byproducts
Hogs meat
Hogs fat
Hogs meat byproducts
Horses meat
Horses fat
Horses meat byproducts
Milk fat, reflecting negligible
residues in milk
Poultry meat
Poultry fat
Poultry meat byproducts
Sheep meat
Sheep fat
Sheep meat byproducts
Current Tolerance
(ppm)
1
1
1
0.1
1
1
1
1
1
1
1
1
1
0.5
1
1
1
1
1
1
Tolerance
Reassessment (ppm)
1
1
1
Revoke: Use on
poultry was
voluntarily cancelled,
tolerance is no longer
necessary
1
1
1
1
1
1
1
1
1
0.02
See eggs above
See eggs above
See eggs above
1
1
1
Comment/Correct Commodity
Definition
Cattle, meat
Cattle, fat
Cattle, meat byproducts
Use withdrawn
Goats, meat
Goats, fat
Goats, meat byproducts
Hogs, meat
Hogs, fat
Hogs, meat byproducts
Horses, meat
Horses, fat
Horses, meat byproducts
Milk (Tolerance expression
should be revised to reflect
levels in milk not milk fat)
Use withdrawn
Use withdrawn
Use withdrawn
Sheep, meat
Sheep, fat
Sheep, meat byproducts
CODEX HARMONIZATION

      The FAO/WHO Joint  Committee  on Pesticide Residue (JMPR) has
recommended Guideline Levels (GL; Step 4) for residues of coumaphos and its
oxygen analog in animal commodities.  The U.S. tolerances are expressed in terms
of the same residues. GLs and corresponding U.S. tolerances are summarized in
the Table below. Meat tolerances and GL levels are the same only for cattle and
poultry meat (1 ppm).  The GLs for goat, swine, and sheep meat (0.5 ppm) are
lower than the corresponding U.S. tolerances (1 ppm).  The U.S. tolerance for
milk fat will be modified to harmonize with the CODEX GL for milk. The GL for
                            60

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      eggs (0.05 ppm) is lower than the U.S. tolerance of 0.1 ppm; however, this is not
      of concern because the U.S. tolerances for poultry meat and eggs should be
      revoked as there are no registered uses of coumaphos on poultry.  The available
      residue data do not support lowering the U.S. tolerance for coumaphos residues
      in goat and pig meat to 0.5 ppm.
                   JMPR GLs and Applicable U.S. Tolerances.
Commodity
Cattle meat
Eggs
Goat meat
Milks
Pig meat
Poultry meat
Sheep meat
GL
(mg/kg) '
1 (fat)
0.05
0.5 (fat)
0.02
0.5
1
0.5
U.S. Tolerance
Reassessment
(ppm)
1
0.1
1
0.02 in milk
1
1
1
Recommendation/
Comments
GL and U. S tolerance are compatible
U.S. tolerance to be revoked

Codex GL and U.S. tolerance are
compatible

U.S. tolerance to be revoked

1. GLs are established for the sum of coumaphos and its oxygen analogue (fat-soluble).

      2.     Summary of Risk Management Decisions

             a.    Human Health

                   (1)    Dietary

                   Acute Dietary

                          The acute  dietary analysis for  the infant subgroup (<1)
                   reaches an MOE of 100  at the 90 percentile.  However, the dose
                   required to produce RBC inhibition at 3 weeks was used to perform
                   the acute dietary (single  dose) risk assessment.  This is the most
                   appropriate data available to the Agency for  risk assessment,
                   however, this approach in all likelihood overestimates the dose that
                   would be  expected  to  produce  ChE  inhibition from a  single
                   exposure.  Actual  MOEs are expected  to be at or near 100 from
                   dietary exposure.  Additional, toxicological data to further refine
                   the acute dietary  risk assessment will not be  required for the
                   reasons specified below.

                          Infant formula is  a mixed or blended commodity and not
                   normally taken directly from one dairy  cow.  Any such mixing or
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blending would tend to reduce the variability in residue levels in
the composite samples which children would consume.  This would
in effect reduce the likelihood of consuming milk with  residue
levels at or near the tolerance. The practical effect of mixing or
blending would be to lower the residues observed in composite
samples, making residue levels closer to the average or  median
estimated value.

      In addition, Agency analysis cannot consider the effect of
processing (e.g.  pasteurization)  or cooking which would likely
reduce coumaphos levels because these data are not available. The
Agency  analysis also assumes  that both  meat and milk are
consumed with coumaphos residues present in both commodities
at the highest level observed in the feeding studies.  Although this
is possible, it is highly unlikely and should be considered as
conservative,  i.e., protective of public health.

(2)   Handler (Mixer/Loader/Applicator)

Acute (Short-Term) and Intermediate

      The Agency  does not have  chemical-specific data for
coumaphos and preliminary  calculations using  surrogate data
(PHED)  indicate a  potential for  unacceptable handler exposure
and/or risk from coumaphos as it  is currently registered.

      For dip-vat  treatments,  however, the USDA routinely
monitors the  cholinesterase activity  of its employees actively
involved in the fever-tick quarantine program (Boophilus spp.,
Dermacentor nitems. and exotic ticks). Therefore, all USDA uses
of coumaphos in dip-vats (and spray treatment) to treat for Texas
Cattle  Fever  (Southern Fever) are  considered  eligible  for
reregistration.  The Agency is aware that there  are other non-USDA
dip-vats located in Colorado and  Texas, however, when there are
quarantine or tick problems the USD A/APHIS operates those dip-
vats for  the duration of the  quarantine treatment(s).  In those
instances, the cholinesterase levels  of the  handlers (mixers/
loaders/applicators) involved in treating the  cattle  would  be
monitored by the USDA.

      For spray  applications  to livestock, the Agency  has
conducted  rough  risk assessments  for  the  various exposure
scenarios registered for use. The Agency has roughly calculated
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handler exposure and risk estimates based on a handler handling
0.5 Ib ai (minimum use rate sufficient to treat 100 cattle) and 5.0 Ib
ai/day  respectively  for spray operations.  This corresponds to
treating 100 and 1,000 cattle with coumaphos per day.  MOEs for
these exposure scenarios  were  calculated to be 82 and  8.2,
respectively.   However, uncertainties  in  the existing handler
exposure databases (PHED) do not allow the  Agency to determine,
with confidence,  the exact MOEs for the  various  exposure
scenarios. Therefore the Agency is requiring exposure data as
outlined in Part V of this RED. In the interim, the  Agency is
imposing a label advisory for individuals to limit the number of
animals they treat per day to no more than 100 (assuming animals
are treated at the maximum dose, 200 if treated at 1/2  max. dose
etc.).   The Agency is  also  requiring closed  systems/improved
packaging (water soluble bags for powders; and, gel pack or "no
glug" containers or equivalent system approved by the Agency for
flowables)  to minimize  exposure  during  mixing/loading of
coumaphos products for use in dip vats or application by hand-held
sprayers as discussed above.

       The Agency has determined that a decision concerning the
reregi strati on of non-USDA  uses of coumaphos  cannot be made
until  occupational  handler exposure  data are received  and
reviewed. The handler exposure studies should be conducted using
the closed systems required as part of this RED.

Post-Application

       The Agency believes that there is minimal  potential
exposure to persons entering treated  sites after application is
complete because most coumaphos is applied directly to animals.
However, contact with treated livestock shortly after treatment
could result in coumaphos exposure.  USDA workers are involved
in a monitoring program  and  are  withdrawn  from  treatment
programs if ChE is significantly depressed. A decision concerning
the reregi strati on of non-USDA uses of coumaphos cannot be made
until occupational handler exposure data, which include  evaluation
of post-application exposure, are received and reviewed.
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b.    Environmental

      (1)    Avian

             Technical coumaphos is highly to very highly toxic to birds.
      Birds may be exposed to coumaphos by feeding in the vicinity of
      treated cattle, or directly from the hides of treated cattle. However,
      the limited use pattern, i.e., only used for direct livestock treatment,
      is expected to confine problems to areas around feedlots or other
      areas where treated cattle  may congregate.   There is only one
      known avian incident during the thirty years that coumaphos has
      been registered for use and the source of exposure in that incident
      is unknown.  Coumaphos is not expected to cause chronic effects
      because any exposure large enough to cause a chronic effect would
      likely be a lethal dose.

      (2)    Mammals

             Coumaphos  is not expected  to pose a direct risk to non-
      target endangered or non-endangered mammals.  There is no
      evidence that the use of coumaphos  on livestock  will  result in
      direct exposure to non-target mammals.

      (3)    Insects

             Coumaphos' use pattern is not expected to pose a direct risk
      to  beneficial insects.   There is  no  evidence that the use of
      coumaphos on livestock will result in significant exposure to
      beneficial insects.

      (4)    Freshwater  fish

             Fish could be exposed to coumaphos if treated livestock
      enter bodies of water shortly after  treatment.  The Agency has
      calculated that  over 100 cows must wade  into a 1  acre body of
      water  in  order for the most sensitive Level  of  Concern (i.e.,
      endangered species) for fish to  be exceeded.  This  indicates that
      coumaphos  does not pose  a  threat to  endangered  or  non-
      endangered fish species on an acute basis.  Coumaphos does not
      pose a risk to fish on a chronic basis.
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(5)    Aquatic invertebrates

       Coumaphos has the potential for causing adverse effects in
aquatic invertebrates due to its high acute toxicity.  Coumaphos is
also sufficiently toxic on a chronic basis to cause a high risk to
invertebrates.  Aquatic organisms could be exposed to coumaphos
if treated cattle enter bodies of water. Cattle enter bodies of water,
particularly in the summer,  for relief from heat and insects.  The
Agency does not expect sensitive, relatively undisturbed aquatic
ecosystems to be closely associated with feedlots. The  Agency
previously required studies to quantify the extent of washoff of
coumaphos from cattle hides after treatment with coumaphos.  The
studies indicate that between 2.0 - 38% of the applied coumaphos
could be washed off the cattle hide depending upon formulation
and drying time  or interval.   The available data indicate that after
24 hours the  amount of coumaphos washed off would be a very
small percentage, i.e., 2  - 3%.  The Agency believes that the acute
and  chronic risks to  aquatic organisms can be addressed with a
label advisory.

(NOTE:    USDA  policy,   detailed   in  Veterinary   Services
Memorandum 556.1, is to restrict cattle from entering streams or
ponds  for at  least 7  days after treatment.  This use constitutes
almost half of the total U.S. coumaphos usage.)

(6)    Estuarine & marine organisms

       Data on acute toxicity to estuarine and marine organisms are
required to support the registration of end use products intended for
direct application to the estuarine or marine environment  of if the
product  is expected to  enter  this environment in  significant
concentrations  because of  its  use pattern  or mobility.   The
registered uses of coumaphos do not meet these criteria. Literature
data available indicate  that  coumaphos is highly  toxic to marine
fish  and invertebrates, however, coumaphos exposure  to these
species is not likely due to its use pattern.

(7)    Nontarget plants (Terrestrial, Semi-Aquatic & Aquatic)

       Coumaphos is a livestock insecticide/acaricide and is not
used on  agricultural  crops  or ornamental plants.  Exposure to
               65

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nontarget plants is assessed to be minimal. Plant testing was not
required for this insecticide.

(8)    Endangered species

       Endangered species LOCs have been exceeded for aquatic
invertebrates and birds.  When the Endangered Species Protection
Program becomes final, limitations in the use of coumaphos may
be required to protect endangered and threatened species, but these
limitations have not been defined and may be formulation specific.

(9)    Surface & ground water

       Coumaphos is used as an acaricide for control of the
southern tick (Boophilus microplus) and the cattle tick (Boophilus
annulatus) by the Animal and Plant Inspection Service (APHIS), in
its Tick Eradication Program.  Several hundred thousand head of
cattle are dipped every year in one of the ca. 45 USD A vats along
the U.S.-Mexican border.  The vats contain approximately 15,000
liters  of  coumaphos solution  with  the  active  ingredient
concentration  of 0.15-0.31%.  Vats  are  emptied, cleaned, and
recharged every six to 12 months, depending on usage, generating
approximately one million liters of coumaphos waste  per year.
Typically the vats are recharged when the  sediment level reaches
10% of the total volume.

       Coumaphos is essentially immobile and  persistent is soil,
but  is apparently  more  mobile when  applied  at  the  high
concentrations that occur is disposal pits. The Agency believes that
threats to ground water  can  be mitigated  without excessive
difficulty or expense using the techniques discussed below.

       Since 1986 the Agricultural Research Service of the USDA
has been conducting research (e.g. see, Journal of Agricultural &
Food Chemistry, July/August 1988, 831-834) concerning the
degradation of coumaphos in cattle-dipping vats. Dip vat solutions
of coumaphos  can be inactivated through the metabolic action of
bacteria that  are  naturally present  in  some  dip vats.   The
USDA/ARS has been experimenting with microbial degradation of
the spent vat solutions and has now successfully demonstrated a
detoxification  procedure.   This  procedure has been  tested  in
laboratory scale equipment and most recently in the field in a full
scale (4,000 gallon tank) pilot test conducted in Texas. Two spent
               66

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vat solutions were bioremediated to ca. 10 ppm.  To date field
testing of this bioremediation method indicates that coumaphos
levels in the spent vat solutions are reduced from ca.  1200-1300
ppm to  10 ppm in approximately two weeks.  The spent solution
would then be put into  lined evaporation pits.  Currently  the
untreated 1200-1300 ppm spent solution is deposited in unlined
evaporation pits.   It  may be  possible,  depending on  local
regulations,  to eliminate  the need for the  evaporation  ponds
altogether and simply spray the treated or bioremediated waste vat
solution  directly  onto  the ground  in  order  for further in-situ
bioremediation to occur.   This decision should be made by  the
individual states involved who are most familiar with the soil types
and ground water situation in their area. In any case the Agency
endorses this method of treatment.  The Agency has concerns about
leakage of spent  dip vat  solution  from lined evaporation ponds.
Reducing the absolute amount of active ingredient in the spent vat
solution deposited in the evaporation ponds greatly mitigates the
Agency's  concern with leakage.   This procedure  appears to be
relatively  inexpensive   and  initial  communication   with
USD A/APHIS, the dip vat operators, indicates that this treatment
of vat solutions is being pursued.

       The Agency considers the aerobic biodegradation of the
spent dip vat  solution in this manner critical in preventing  the
downward and or lateral movement of coumaphos and ultimately
in preventing the contamination of groundwater.  Although this will
result in increased  cost, the use of bioremediation is certainly much
less expensive than any "clean-up" of groundwater that may be
necessary if even one evaporation pond were to  leak.  Because this
is new   a  procedure   and  will require  capital  upgrades
(bioremediation tank and/or lined pits)  the Agency will phase this
disposal method revision in over a two year period. The Agency
also understands that technical assistance, e.g., answering questions
concerning construction of bioremediation tanks, will initially be
provided  by  USDA/ARS.   The  USDA/ARS will not operate
bioremediation sites to treat non-USDA spent dip vat solutions.

       The Agency is requiring labeling that requires the use of this
bioremediation procedure and/or the use of lined pits.  If lined pits
are used without first bioremediating the spent vat solutions, then
protocols must be submitted to monitor the lined pits for leakage.
The Agency is allowing local and/or State Environmental Control
Agencies the option to permit use of lined evaporation ponds.  The
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             Agency believes that  the  lined evaporation pond  method  of
             disposal is much less desirable than bioremediation and that it
             should be  permitted only in those instances when use of the
             bioremediation method is not feasible.   Exact label language
             required is found in Part V.

3.     Restricted Use Classification

       Coumaphos 11.6% EC and 42% flowable concentrate formulations must
bear the following restricted-use statement:

       "RESTRICTED USE CLASSIFICATION
        Due to acute oral hazards
       For retail sale to and use only  by certified  Applicators or persons under
       their direct supervision and only for those uses covered by the Certified
       Applicator's Certification."

       NOTE:  Closed system that precludes oral exposure  (poisoning)  may
       obviate the need for restricted use classification.

4.     Reference Dose Exceedance

       When only the supported uses are considered the ARCs for the  U.S.
population and all ORES subgroups are well below the Reference Dose.

5.     Endangered Species Statement

       Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify all pesticides whose use may cause  adverse
impacts on endangered  and threatened species and to  implement mitigation
measures that will address the adverse impacts.  The program would require use
restrictions to protect endangered and threatened species at the county level.
Consultations with the Fish and Wildlife Service may be necessary to assess risks
to newly listed species or from proposed new uses.  In the  future, the  Agency
plans to publish a description of the Endangered Species Program 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
requirement for the product use modifications will occur in the future under the
Endangered Species Protection Program.
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6.     Labeling Rationale

Occupational and Residential Labeling Rationale/Risk Mitigation

The Worker Protection Standard (WPS)

       At this time, there are no registered uses of coumaphos within the scope of
the WPS. WPS does not include uses on livestock or other animals, or use in or
around animal premises.

Personal Protective Equipment/Engineering Controls for Handlers

       For each end-use product, PPE requirements for pesticide handlers are set
during reregi strati on in one of two ways:

       1. If EPA determines that no regulatory action must be taken as the result
       of the acute effects or other adverse effects of an active ingredient, the PPE
       for pesticide handlers will be based on the acute toxicity of the end-use
       product. For occupational-use products, PPE must be established using the
       process described in PR Notice 93-7 or more recent EPA guidelines.

       2. If EPA determines that regulatory action on an active ingredient must be
       taken as the result of very high acute toxicity or to certain other adverse
       effects, such as allergic effects or delayed effects (cancer, developmental
       toxicity, reproductive effects, etc.):

       •     In the RED for that active ingredient, EPA may establish minimum
             or "baseline" handler PPE requirements that pertain to all or most
             end-use products containing that active ingredient.

       •     These minimum PPE requirements must be compared with the PPE
             that would be designated on the basis of the acute toxicity of the
             end-use product.

       •     The  more stringent choice for each type of PPE (i.e., bodywear,
             hand protection, footwear, eyewear, etc.) must be placed on the
             label of the end-use product.

       Personal protective equipment requirements usually are set by specifying
one or more pre-established PPE units — sets of items that are almost always
required together.  For example,  if chemical-resistant gloves are required, then
long-sleeve shirts, long pants, socks, and shoes are assumed and are also included
in the required minimum  attire.   If the requirement is for  two layers of body
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protection (coveralls over a long- or short-sleeve shirt and long or short pants), the
minimum must also include (for all handlers) chemical-resistant footwear and
chemical-resistant headgear for overhead exposures and (for mixers, loaders, and
persons cleaning equipment) chemical-resistant aprons.

Occupational-Use Products

       EPA has determined that regulatory action regarding the establishment of
active-ingredient-based minimum PPE requirements for occupational handlers
must be taken for coumaphos. The MOEs for  dermal exposure were a serious
concern for mixers, loaders, and applicators. EPA is requiring active-ingredient-
based protections for handlers of coumaphos in  these exposure situations.

       Based on the unacceptable MOE calculated for the handwand spray
applications, the minimum (baseline) PPE for all  coumaphos end-use products is:
long-sleeved  shirt,  long pants,  chemical-resistant gloves, chemical-resistant
footwear and socks for all handlers. In addition, mixer/loaders supporting spray
applications and handlers (mixers, loaders, and applicators) participating in dip-vat
applications must wear a chemical-resistant apron and face shield or goggles.

Homeowner-Use Products

       Currently there  are  no coumaphos  products  intended  primarily for
homeowner use.

Post-Application/Entry Restrictions

Occupational-Use Products

       Since EPA has some concerns about post-application exposures to persons
contacting treated animals immediately after liquid applications of coumaphos, it
is establishing restrictions on contact with treated livestock on all end-use products
containing directions for use as a livestock spray or dip. For specific requirements,
refer to Section V of this document.

Homeowner-Use Products

       Currently there  are  no coumaphos  products  intended  primarily for
homeowner use.
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             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 coumaphos. For the specific labeling
             statements, refer to Section V of this document.
V.    ACTIONS REQUIRED BY REGISTRANTS

      This section specifies the data requirements and responses necessary for the reregi strati on
of both manufacturing-use and end-use products.

      A.    Manufacturing-Use Products

             1.     Additional Generic Data Requirements

                    The generic data base supporting the reregi strati on of coumaphos for the
             above eligible uses has been reviewed and determined to be substantially complete
             with the exception of occupational (mixer/loader/applicator) exposure data. The
             following data are required before the Agency can make a regulatory decision
             regarding reregi strati on eligibility:

                    Handler exposure

                    Guideline 231:      Estimation of Dermal Exposure at Outdoor Sites

                                       o      Mixing/loading/application   of   dipping
                                              solutions for both the liquid and wettable
                                              formulations. These studies must include the
                                              impact  of  the  closed  systems/improved
                                              packaging on mixing/loading exposure, e.g.,
                                              water soluble bags for the WP formulation.

                                       o      Mixing/loading  operations for backrubber
                                              and dust bag setups.

                                       o      Mixing/loading/application  of  liquid and
                                              wettable  powder formulations using high
                                              and low-pressure handwand sprayers.  These
                                              studies must include the impact of the closed
                                              systems/improved packaging on  mixing/
                                              loading  exposure, e.g., water soluble bags
                                              for the WP formulation.
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                    o     Application   of  ready-to-use,   pour-on
                          solutions.

                    o     Application with shaker cans,  foam spray
                          can,  and   application  with  mechanical
                          dusters.

Guideline 232:       Estimation of Inhalation Exposure at Outdoor Sites

                    o     Mixing/loading/application   of   dipping
                          solutions for both the liquid and wettable
                          formulations. These studies must include the
                          impact  of  the closed  systems/improved
                          packaging on mixing/loading exposure, e.g.,
                          water soluble bags for the WP formulation.

                    o     Mixing/loading operations for backrubber
                          and dust bag setups.

                    o     Mixing/loading/application  of liquid  and
                          wettable powder formulations using high
                          and low-pressure handwand sprayers.  These
                          studies must include the impact of the closed
                          systems/improved packaging  on  mixing/
                          loading  exposure, e.g., water soluble bags
                          for the WP formulation.

                    o     Application   of  ready-to-use,   pour-on
                          solutions.

                    o     Application with shaker cans,  foam spray
                          can,  and   application  with  mechanical
                          dusters.
The following data are considered confirmatory:

Environmental Fate

Guideline 162-3     Anaerobic Aquatic Metabolism

                    This information is needed to ascertain the effects of
                    anaerobicity, a condition which can have an effect


                      72

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                          on   many  oxidation-reduction   systems,   and
                          consequently may indirectly affect the metabolism
                          and fate of coumaphos.

NOTE:  Acute and subchronic neurotoxicity testing of coumaphos required in the
1992 DCI is still required.  The registrant requested and was granted a time
extension, due to the large number of active ingredients they must test. Due dates
for these studies are unchanged by this RED: 4/30/98 for the acute study and
11/30/98 for the subchronic study.  In addition, the registrant must upgrade the
aqueous photolysis study by explaining why an unknown, possibly a degradate,
was detected at a concentration of 0.06 ppm (11.6%) and eluted at a retention time
of 4 minutes in the HPLC chromatogram was present in the original study (MRID
42764101) but was not present in the replacement study.

2.     Labeling Requirements for Manufacturing-Use Products

      To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices,
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:

      "Only for formulation into a insecticide  for the following use(s): beef
cattle, dairy cattle, sheep, goats, horses, swine and swine bedding."

      An MP  registrant may, at his/her discretion, add one of the following
statements to an MP label under "Directions for Use" to permit the reformulation
of the product for a specific use or all additional uses supported by a formulator
or user group:

      (a)    "This product may be used to formulate products for specific use(s)
             not listed on the MP label if the formulator, use group, or grower
             has complied with U.S. EPA submission requirements regarding
             the support of such use(s)."

      (b)    "This product may be used to formulate products for any additional
             use(s) not listed on the MP label if the formulator, user group, or
             grower  has  complied with U.S.  EPA submission requirements
             regarding the support of such (use)s."
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B.     End-Use Products

       1.     Additional Product-Specific Data Requirements

             Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
       product-specific data regarding the pesticide after a determination of eligibility has
       been made. The product specific data requirements are listed in Appendix D, the
       Product Specific Data Call-In Notice.

             Registrants must review previous data submissions to ensure that they meet
       current EPA acceptance criteria and if not, commit to conduct new studies.  If a
       registrant believes that previously submitted data meet current testing standards,
       then study MRID numbers should be  cited according to the instructions in the
       Requirement Status and Registrants Response Form provided for each product.

       2.     Labeling Requirements for End-Use Products

       a. Restricted Use Classification

          The 1989 Registration Standard classified coumaphos  11.6% EC and 42%
       flowable concentrate end-use products as restricted use  due to high acute oral
       toxicity.

       NOTE: Closed system(s) that precludes oral exposure (poisoning) may obviate
       the need for restricted use classification.


       b. Worker Protection

             PPE/Engineering Control Requirements for Pesticide Handlers

             For sole-active-ingredient end-use products that contain coumaphos, the
       product labeling must be revised to adopt the handler personal protective equip-
       ment/engineering control requirements set forth in this section. Any conflicting
       PPE requirements on the current labeling must be removed.

             For multiple-active-ingredient end-use products that contain coumaphos
       must compare  the  handler personal protective equipment/engineering control
       requirements set forth in this section to the PPE requirements on their current
       labeling and retain the more protective. For guidance on which PPE is considered
       more protective, see PR Notice 93-7.
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Products Intended Primarily for Occupational Use

Minimum (Baseline) PPE/Engineering Control Requirements

       EPA  is  establishing  active-ingredient-based   minimum  (baseline)
engineering control requirements for liquid-concentrate and wettable-powder
formulations. EPA is also establishing active-ingredient-based minimum (baseline)
personal protective equipment requirements for all handlers.

       Ready-To-Use Products: EPA is establishing minimum (baseline) PPE
for all ready-to-use formulations of coumaphos as follows:

Applicators and other handlers must wear:
       — long-sleeve shirt and long pants,
       — chemical-resistant gloves*, and
       — shoes plus socks.

       Wettable Powder Products:  EPA is requiring that wettable powder
formulation be  contained  in  water-soluble  packets.    In  addition,  EPA  is
establishing minimum  (baseline) PPE for wettable powder  formulations  as
follows:

       "Handlers exposed to the concentrate, such as during a spill, or equipment
       break-down, and all handlers participating in dip-vat applications must
       wear:
       — long-sleeve shirt and long pants,
       — chemical-resistant gloves*,
       — chemical-resistant footwear plus socks,
       — chemical-resistant apron, and
       — face shield or goggles.
       "All other handlers must wear:
       — long-sleeve shirt and long pants,
       — chemical-resistant gloves*, and
       — chemical-resistant footwear plus socks."

       "Water-soluble packets when used correctly qualify as a closed loading
       system. Handlers handling this product while it is enclosed in intact water-
       soluble packets are permitted  to wear long-sleeved  shirt, long pants,
       chemical-resistant gloves*,  shoes  plus socks, and a chemical-resistant
       apron. However, such handlers must be provided a face shield or goggles
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       and have such PPE immediately available for use in a emergency, such as
       a spill or equipment break-down."

   Emulsifiable Concentrate and Flowable Concentrate Products: EPA is
requiring  that all liquid concentrate  formulations be contained in  "no-glug"
containers, water-soluble gel-packs, or other equivalent methods approved by the
Agency. In addition, EPA is establishing minimum (baseline) PPE requirements
for all liquid-concentrate formulations as follows:

   "Mixers, loaders, and others exposed to the concentrate (such as during a spill
   or  equipment  break-down)  and  all  handlers  participating in  dip-vat
   applications must wear:
   — long-sleeve shirt and long pants,
   — chemical-resistant gloves*,
   — chemical-resistant footwear plus socks,
   — chemical-resistant apron, and
   — face shield or goggles.

   "All other handlers must wear:
   — long-sleeve shirt and long pants,
   — chemical-resistant gloves*,  and
   — chemical-resistant footwear plus socks."

* For the glove statement, use the statement established for coumaphos through
the instructions in Supplement Three of PR Notice 93-7.

Determining PPE Requirements for End-use Product Labels

   The PPE that would be established on the basis of the acute toxicity category
of the end-use product must be compared to the active-ingredient-based minimum
(baseline) personal protective equipment specified above. The more  protective
PPE must be placed on the product labeling. For guidance on which PPE is
considered more protective, see PR Notice 93-7.

Placement in Labeling

   The personal protective equipment requirements must be placed on the end-
use product labeling in the location specified in PR Notice 93-7,  and the format
and language of the PPE requirements must be the same as is specified in PR
Notice 93-7.
                            76

-------
Entry Restrictions

   For sole-active-ingredient end-use products that contain coumaphos the
product labeling must be revised to adopt the entry restrictions set forth in this
section.  Any  conflicting  entry restrictions  on the current labeling must be
removed.

   For multiple-active-ingredient end-use products that contain coumaphos the
entry restriction set forth in this section must be compared to the entry restrictions
on the current labeling and the more protective must be retained.

Products Intended Primarily for Occupational Use

"Do not contact treated animals until their coats are dry."

Entry restrictions  do not apply to coumaphos treatment of swine bedding.

Placement in labeling:

   Place the entry restrictions in the Directions for Use, under the heading  "Entry
Restrictions."

Other Labeling Requirements

Products Intended Primarily for Occupational Use

   The Agency is requiring the following labeling  statements be located on all
end-use  products containing coumaphos  that are  intended  primarily  for
occupational use:

Application Restrictions:

"Do not apply this  product in a way  that will contact workers or other persons,
either directly  or through drift.  Only protected handlers may be in the area
during application."

The following  restriction must appear on products labeled for hand held sprayer
application:

"Individuals must limit the number of animals they treat per day with hand held
sprayers to no more than 100, if the  animals are treated at the maximum label rate,
200 if they are treated at 1/2 maximum label rate, etc."
                             77

-------
User Safety Requirements:

1.   Registrant, place the following statement on  end-use product labeling if
coveralls are required for pesticide handlers:

"Discard clothing or other absorbent materials that have been drenched or heavily
contaminated with this product's concentrate. Do not reuse them."

2.   Registrant, always place the following statement on the end-use product
labeling:

"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
instructions for washables, use detergent and hot water.  Keep and wash PPE
separately from other laundry."

User Safety Recommendations:

    "Users should wash hands  before eating, drinking, chewing gum, using
    tobacco, or using the toilet."

•    "Users should remove clothing immediately if pesticide gets inside. Then
    wash thoroughly and put on clean clothing."

•    "Users should remove PPE immediately after handling this product. Wash the
    outside of gloves before removing. As soon as possible, wash thoroughly and
    change into clean clothing."

Environmental Hazard Statements

All labels must have standard language, including:

"This pesticide is toxic to mammals, birds, fish and aquatic  invertebrates."

"Coumaphos washed off of wading treated livestock may be hazardous to aquatic
organisms."

"Do not contaminate water when disposing of equipment washwater or rinsate."

Premise Precautions

    All products labeled for use in livestock premise or areas must include the
following:
                            78

-------
          "Do not spray in a confined, non-ventilated area."

          "Do not treat areas such as drinking cups, mangers, or troughs where livestock
          feed."

          "Do not contaminate water, food, feedstuffs, food or feed handling equipment, or
          milk or meat handling equipment."

   ANIMAL DIPPING-VAT DISPOSAL

   DISPOSAL OF SPENT VAT SOLUTION

   "Cattle Dip Vat Solution Disposal: Contact your Local  and/or State Environmental
   Control Agency for specific recommendations or details for the geographical area where
   the  dip  vat  is located.   The  Agency  recommends that spent dip-vat solution  be
   bioremediated in accordance with a method  developed by the USDA.  The treated
   solution can then be transferred to lined, shallow evaporation ponds or incorporated into
   the soil to encourage further degradation.  If an evaporation pond is used it should be
   constructed to prevent overflow or flooding during wet seasons and should be lined with
   compacted clay, reinforced concrete or flexible membrane liner.  Questions concerning
   the disposal of the spent solution should be directed to the waste representative at the
   nearest EPA Regional Office.  Details are available concerning the bioremediation
   procedure and ultimate disposition of the remediated solution. Do not apply dried sludge
   or  the  bioremediated/treated  solution to  land  used for raising  crops  for  human
   consumption."

   OTHER LABEL RESTRICTIONS

       Other current label restrictions, e.g., restrictions  against treating lactating cows, or
   other limitations/precautions on existing labels are still applicable and are required for
   product reregi strati on if the product is to remain in compliance with FIFRA.

C. Existing Stocks

   Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision (RED).
Persons other than the registrant may generally distribute or sell such products for 50 months
from the date of the issuance of this RED. However, existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of label
changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register. Volume 56, No. 123, June 26,  1991.
                                      79

-------
    The Agency has determined that registrants may distribute and sell coumaphos products
bearing old labels/labeling for 26 months from the date of issuance of this RED. Persons
other than the registrant may distribute or sell such products for 50 months from the date of
the issuance of this RED. Registrants and persons other than registrants remain obligated to
meet pre-existing Agency imposed label changes and existing stocks requirements applicable
to products they sell or distribute.
                                       80

-------
VI. APPENDICES
       81

-------
SITE Application Type, Application
  Timing, Application  Equipment
FOOD/FEED USES
                  APPENDIX  A  )   CASE 0018,  [Coumaphos] Chemical 036501  [Coumaphos]

                 44444444444444444444444444444444444444444444444444444444444444444444444444444,
Form(s)   Min. Appl.      Max.  Appl.  Soil  Max.  # Apps Max.  Dose [(AI   Min.  Restr.     Geographic  Limitations      Use
         Rate  (AI un-       Rate  (AI  Tex.  @ Max. Rate unless noted    Interv Entry      Allowed        Disallowed   Limitations
         less noted    unless  noted  Max.  /crop /year otherwise)/A]    (days) Interv                                  Codes
         otherwise)       otherwise)  Dose  cycle       /crop    /year          [day(s)]
                                                      cycle
BEEF/RANGE/FEEDER CATTLE  (MEAT)

Animal treatment  (back  rubber).,  When
needed.,  Not on label.
Animal treatment  (dust)., When needed.
bag.
                               Use Group:  INDOOR FOOD

                                 UC    *   NS     NS
                                                                   NS   AN     NS
                                                                                                                    C04,  S09(0)
Animal treatment  (dust)., When needed.
Duster.

Animal treatment  (dust)., When needed.
held duster.
Animal treatment  (dust)., When needed.
held sprayer.

Animal treatment  (dust)., When needed.
Mechanical duster.

Animal treatment  (dust)., When needed.
on label.

Dust





Hand

Hand

Not


EC
D
D
D
D
D
D
D
D
D
D
D
D
D
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC
.005 Ib animal
6.250E-04 Ib
animal
6.250E-04 Ib
animal
6.250E-04 Ib
animal
6.250E-04 Ib
animal
.001 Ib animal
.001 Ib animal
6.250E-04 Ib
animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
26/1 yr
NS
NS
NS
26/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
.03 Ib
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
1
1
1
1
14
14
10
14
14
14
10
14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C04,
C04,
C04,
C04,
C04,
G64,
C04,
C04,
C04,
C04,
C04,
C04,
C04,
C04,
C93,
G64,
G64,
G64,
FOB
S09(0)
S06
S09(0)
S09(0)
S06
G64,
G64,
G64,
G64,
G64,
G64,
G64,
G64,

S09(0)
S09(0)
S09(0)
S09(0)
S09(0)
S09(0)
S09(0)
S09(0)
                                                                                             82

-------
SITE Application Type, Application
  Timing, Application Equipment
FOOD/FEED USES  (con't)
                  APPENDIX A   )   CASE 0018,  [Coumaphos]  Chemical 036501  [Coumaphos]

                 4444444444444444444444444444444444444444444444444444444444444444444
Form(s)   Min. Appl.       Max. Appl. Soil Max.  #  Apps  Max.  Dose [(AI   Min.  Restr.
         Rate (AI un-      Rate  (AI Tex. @ Max.  Rate  unless noted    Interv Entry
         less noted    unless noted Max. /crop /year  otherwise)/A]
                         Geographic Limitations
                      Allowed           Disallowed
                                                    otherwise)
                                                                    otherwise) Dose cycle
                                                      /crop
                                                       cycle
/year
(days)  Interv
       [day(s)]
                                              Use
                                              Limitations
                                              Codes
BEEF/RANGE/FEEDER CATTLE  (MEAT)  (con't)

Animal treatment  (dust)., When  needed.,
Shaker can.
Animal treatment  (dust)., When  needed.,
Squeeze applicator.

Animal treatment  (ear)., When needed.,
Aerosol can.
Animal treatment  (ear)., When needed.,
Squeeze applicator.

Animal treatment  (spray)., When  needed.
High pressure sprayer.
                               Use Group:  INDOOR FOOD (con't)

                      .001 Ib animal    *  NS     NS         NS
Animal treatment  (spray)., When  needed.,
Sprayer.
Animal treatment  (wound)., When  needed.,
Aerosol can.
Animal treatment  (wound)., When  needed.,
High pressure sprayer.

Animal treatment  (wound)., When  needed.,
Squeeze applicator.

Animal treatment., When  needed.,  Duster.
D
D
PRL
PRL
D
EC
EC
F1C
WP
EC
F1C
WP
PRL
PRL
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.001 Ib animal
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
* NS
* NS
* NS
* NS
* NS
* 2
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
AN
AN
AN
AN
NS
14
14
14
AN
14
AN
AN
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
         NA
                                 UC
                                         NS
                                                NS
                                                           NS
                                                                   NS   AN
                                                                               NS
                                                    NA                      UC   *  NS    NS         NS       NS    1       NS

                                                             APPENDIX A  )  CASE 0018,  [Coumaphos]  Chemical 036501 [Coumaphos]
                                                     C04,  S09(0)


                                                     C04,  G64,  S09(0)

                                                     C04,  G64,  309(03)


                                                     C04,  G64,  S09(0)


                                                     C04,  G64,  309(03)

                                                     C04,  G64,  309(03)


                                                     C04,  306


                                                     C04,  S06

                                                     309(0)

                                                     C04,  S09(0)

                                                     C04,  306


                                                     S09(0)

                                                     C04,  309(0)

                                                     C04,  G64,  S09(0)


                                                     C04,  G64,  309(03)

                                                     C04,  S06


                                                     C04,  G64,  309(03)


                                                     C04,  G64,  S06
SITE Application Type, Application
  Timing, Application Equipment
FOOD/FEED USES  (con't)
Form(s)   Min. Appl.      Max. Appl. Soil Max.  tt  Apps  Max.  Dose [(AI   Min.  Restr.     Geographic Limitations      Use
         Rate (AI un-      Rate  (AI Tex. @  Max.  Rate  unless noted    Interv Entry   Allowed           Disallowed   Limitations
         less noted    unless noted Max. /crop /year  otherwise)/A]    (days)  Interv                                 Codes
         otherwise)      otherwise) Dose cycle       /crop    /year         [day(s)]
                                                      cycle
                                                                                             83

-------
BEEP/RANGE/FEEDER CATTLE  (MEAT)  (con't)

Animal treatment., When needed., Hand held    D      NA
duster.

Animal treatment., When needed., Mechanical   D      NA
duster.

Dip treatment., When needed., Vat.            F1C    NA

                                              WP     NA

Pour-on., When needed., Not on  label.         RTU    NA


                                              RTU    NA


Spray., When needed., Hand held sprayer.      EC     NA

DAIRY CATTLE  (LACTATING OR UNSPECIFIED)

Animal treatment  (back rubber)., When         EC     NA
needed., Not on label.
Animal treatment  (dust)., When needed.,  Dust  D
bag.
             Use Group:  INDOOR FOOD (con't)

               UC   *  NS    NS         NS
               UC
                       NS    NS
               UC   *  NS    NS

               UC   *  NS    NS
.001563  Ib 100 Ib   *  NS    NS
           animal
NS


NS

NS

NS
.001419 Ib 100 Ib
           animal
                       NS    NS
NS   1


NS   10

NS   10

NS   14


NS   NS
               UC   *  NS    NS

             Use Group: INDOOR FOOD

               UC   *  NS    NS
NS

NS

NS
Animal treatment  (dust)., When needed.,
Duster.
EC
D
D
D
D
D
D
NA
NA
NA
NA
NA
NA
NA
UC
.DOS Ib animal
6.250E-04 Ib
animal
6.250E-04 Ib
animal
6.250E-04 Ib
animal
UC
.001 Ib animal
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
.03 Ib
NS
NS
NS
NS
NS
AN
14
1
1
1
NS
14
NS
NS
NS
NS
NS
NS
NS
C04, G64, S06


C04, G64, S06


S09(0)

C04, S09(0)

S06


C04, S06


C04, C93, FOB



C04, C93, FOB


C04, F06(0)

C04, F06(0),  G64


C04, F04, G64


C04, F06(0),  G64


F04, G64


C04, F06(0)

C04, F06(0),  G64
                                                                                            84

-------
                                                                         APPENDIX A   )   CASE 0018,  [Coumaphos]  Chemical 036501 [Coumaphos]
SITE Application Type, Application
  Timing, Application Equipment
                                           Form(s)
Min. Appl.
Rate (AI un-
less noted
otherwise)
  Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.   Restr.
    Rate (AI Tex. @ Max. Rate unless noted     Interv  Entry
unless noted Max. /crop /year otherwise)/A]
                  Geographic Limitations
               Allowed           Disallowed
                                                                    otherwise)  Dose cycle
                                             /crop
                                             cycle
                                       /year
(days)  Interv
       [day(s)]
Use
Limitations
Codes
FOOD/FEED USES  (con't)
DAIRY CATTLE  (LACTATING OR UNSPECIFIED)  (con't)
Animal treatment  (dust)., When needed., Hand D
held duster.
Animal treatment  (dust)., When needed.,
Mechanical duster.

Animal treatment  (dust)., When needed., Not
on label.
Animal treatment  (dust)., When needed.,
Shaker can.
Animal treatment  (dust)., When needed.,
Squeeze applicator.

Animal treatment  (ear)., When needed.,
Aerosol can.
Animal treatment  (ear)., When needed.,
Squeeze applicator.

Animal treatment  (spray)., When needed.
Sprayer.
Animal treatment  (wound)., When needed.
Aerosol can.
                      Use Group: INDOOR FOOD  (con't)

            .001 Ib animal   *  NS  26/1 yr      NS
                                                                  6.250E-04 Ib   *  NS    NS

D
D
D
D
D
D
D
D
PRL
PRL
D
EC
WP
PRL

NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
UC
UC
UC
UC
UC
UC
UC

* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS

NS
NS
26/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS

NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS

14
14
14
10
14
10
14
AN
AN
AN
AN
AN
AN
AN

NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
                                                                                                          C04,


                                                                                                          C04,


                                                                                                          C04,

                                                                                                          C04,
                                                                                                 F06(0),  G64


                                                                                                 F04,  G64


                                                                                                 F06(0),  G64

                                                                                                 F06(0),  G64
                                                                                                          C04, F06(0),  G64
                                                                                                          C04,

                                                                                                          C04,

                                                                                                          C04,


                                                                                                          C04,

                                                                                                          C04,
                                                                                                 F06(0),  G64

                                                                                                 F06(0),  G64

                                                                                                 F06(0)


                                                                                                 F06(0),  G64

                                                                                                 F04,  G64
                                                                            UC   *  NS    NS         NS      NS   AN     NS

                                                             APPENDIX A  )   CASE 0018,  [Coumaphos] Chemical 036501  [Coumaphos]
                                                                                                          C04, F04, G64


                                                                                                          C04, F06(0),  G64

                                                                                                          C04, F04, G64


                                                                                                          C04, F06(0)


                                                                                                          C04, F06(0)

                                                                                                          C04, F04, G64


                                                                                                          C04, F06(0),  G64
SITE Application Type, Application
  Timing, Application Equipment
FOOD/FEED USES  (con't)
Min. Appl.      Max. Appl. Soil Max. tt Apps Max. Dose  [(AI    Min.   Restr.      Geographic Limitations      Use
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted     Interv Entry   Allowed           Disallowed   Limitations
less noted    unless noted Max. /crop /year otherwise)/A]    (days)  Interv                                  Codes
otherwise)      otherwise) Dose cycle       /crop    /year          [day(s)]
                                            cycle
                                                                                            85

-------
DAIRY CATTLE (NON-LACTATING)

Animal treatment (wound)., When needed.,
Squeeze applicator.

Animal treatment.,  When needed.,  Duster.

Animal treatment.,  When needed.,  Hand held
duster.

Animal treatment.,  When needed.,  Mechanical
duster.

Spray., When needed., Hand held sprayer.
Animal treatment (spray)., When needed.,
High pressure sprayer.
Animal treatment (spray)., When needed.,
Sprayer.
Dip treatment.,  When needed.,  Vat.
Pour-on., When needed., Not on label.
Use Group: INDOOR FOOD

  UC   *  NS    NS
                                                                                   C04,  F04,  G64
D
D
D
EC
EC
F1C
WP
EC
F1C
WP
F1C
WP
RTU
RTU
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
.001563 Ib 100 Ib
animal
.001419 Ib 100 Ib
animal
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
1
1
AN
14
14
14
AN
14
AN
10
10
14
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C04,
C04,
C04,
C04,
C04,
F04
C04,
C04,
F04
C04,
F04
C04,
F04, G64
F04, G64
F04, G64
C93, FOB
F01(14)

F01(14)
F01(14)

F01(14)

F01(14)
F01(14) , FOB
C04,
F01(14) ,
                                                                                           86

-------
SITE Application Type, Application
  Timing, Application Equipment
POOD/FEED USES  (con't)
                  APPENDIX  A  )   CASE 0018,  [Coumaphos] Chemical 036501  [Coumaphos]

                 44444444444444444444444444444444444444444444444444444444444444444444444444444,
Form(s)   Min. Appl.      Max.  Appl.  Soil  Max.  tt Apps Max.  Dose [(AI   Min.  Restr.     Geographic  Limitations      Use
         Rate (AI un-       Rate  (AI  Tex.  @ Max. Rate unless noted    Interv Entry   Allowed            Disallowed   Limitations
         less noted    unless  noted  Max.  /crop /year otherwise)/A]    (days) Interv                                  Codes
         otherwise)       otherwise)  Dose  cycle       /crop    /year          [day(s)]
                                                      cycle
DAIRY GOATS  (NON-LACTATING)

Animal treatment  (spray)., When needed.
Sprayer.

Animal treatment  (wound)., When needed.
Sprayer.

Dip treatment., When needed.,  Vat.

GOATS (MEAT)

Animal treatment  (dust)., When needed.,
Squeeze applicator.

Animal treatment  (ear)., When  needed.,
Squeeze applicator.

Animal treatment  (spray)., When needed.
Sprayer.

Animal treatment  (wound)., When needed.
Aerosol can.

Animal treatment  (wound)., When needed.
Sprayer.

Animal treatment  (wound)., When needed.
Squeeze applicator.

Dip treatment., When needed.,  Vat.

GOATS (WOOL/ANGORA ANIMAL)

Animal treatment  (ear)., When  needed.,
Squeeze applicator.

HOG/PIG/SWINE  (MEAT)

Animal bedding/litter  treatment., When
needed., Duster.
                               Use Group:  INDOOR FOOD

                                 UC    *  NS     NS
                                                           NS      NS   14
                                 UC
                                          NS     NS
                                 UC    *   NS     NS

                               Use Group:  INDOOR FOOD

                                 UC    *   NS     NS
                                 UC
                                          NS     NS
                                 UC    *   NS     NS
                                 UC    *   NS     NS
                                 UC
                                          NS     NS
                                 UC    *   NS     NS

                               Use Group:  INDOOR FOOD

                                 UC    *   NS     NS


                               Use Group:  INDOOR FOOD

                       4.125E-05 Ib    *   NS     NS
                              sq.ft
                                                                   NS   14     NS
                                                                   NS   10     NS
                                                                   NS   AN     NS
                                                           NS      NS   AN     NS
                                                           NS      NS   14
                                                           NS      NS   AN     NS
                                                           NS      NS   14
                                                                   NS   AN     NS
                                                                   NS   10     NS
NS   NS     NS
C04, F01(14),  FOB


C04, F01(14),  FOB


C04, F01(14),  FOB



C04, G64, S09(3)


C04, G64, S09(3)


C04, S09(3)


C04, G64, S09(3)


C04, S09(3)


C04, G64, S09(3)


C04, S09(3)



C04, G64, S09(3)




C04, G64, S09(0)
                                                                                             87

-------
SITE Application Type, Application        Form(s)
  Timing, Application Equipment
POOD/FEED USES  (con't)
         APPENDIX A   )   CASE 0018,  [Coumaphos]  Chemical 036501  [Coumaphos]

        44444444444444444444444444444444444444444444444444444444444444444444444444444,
Min. Appl.       Max. Appl. Soil Max.  tt  Apps  Max.  Dose [(AI   Min.  Restr.     Geographic Limitations       Use
Rate (AI un-      Rate  (AI Tex. @ Max.  Rate  unless noted    Interv Entry   Allowed           Disallowed    Limitations
less noted    unless noted Max. /crop /year  otherwise)/A]    (days)  Interv                                  Codes
otherwise)       otherwise) Dose cycle       /crop    /year         [day(s)]
                                             cycle
HOG/PIG/SWINE  (MEAT)  (con't)
                                                                          Use Group: INDOOR FOOD  (con't)
Animal bedding/litter treatment.,  When
needed., Hand held duster.

Animal bedding/litter treatment.,  When
needed., Mechanical duster.
Animal bedding/litter treatment.,  When
needed., Not on label.
Animal bedding/litter treatment.,  When
needed., Shaker can.
Animal treatment  (dust)., When  needed.,
Duster.
              4.125E-05 Ib    *  NS     NS
                     sq.ft

              4.125E-05 Ib    *  NS     NS
                     sq.ft

              4.125E-05 Ib    *  NS     NS
                     sq.ft

              4.125E-05 Ib    *  NS   36/1  yr
                     sq.ft

              4.125E-05 Ib    *  NS     NS
                     sq.ft

              4.125E-05 Ib    *  NS     NS
                     sq.ft

              4.125E-05 Ib    *  NS     NS
                     sq.ft

              6.250E-04 Ib    *  NS     NS
                    animal
C04, G64, S09(0)


C04, G64, S09(0)


C04, S09(0)


C04, G64, S09(0)


C04, G64, S09(0)


C04, G64, S09(0)


C04, S09(0)


C04, G64, S09(0)
Animal treatment  (dust)., When  needed.,  Hand
held duster.

Animal treatment  (dust)., When  needed.,
Mechanical duster.
Animal treatment  (dust)., When  needed.,  Not
on label.
              6.250E-04 Ib    *  NS     NS
                    animal

              6.250E-04 Ib    *  NS     NS
                    animal

              6.250E-04 Ib    *  NS     NS
                    animal

              6.250E-04 Ib    *  NS   36/1  yr
                    animal

              6.250E-04 Ib    *  NS     NS
                    animal
C04, G64, S09(0)


C04, G64, S09(0)


C04, S09(0)


C04, G64, S09(0)


C04, G64, S09(0)
                                                                                             88

-------
SITE Application Type, Application
  Timing, Application Equipment
FOOD/FEED USES  (con't)
                  APPENDIX A   )   CASE 0018,  [Coumaphos]  Chemical 036501  [Coumaphos]

                 444
Form(s)   Min. Appl.       Max. Appl. Soil Max.  #  Apps  Max.  Dose [(AI   Min.  Restr.      Geographic Limitations      Use
         Rate (AI un-      Rate  (AI Tex. @ Max.  Rate  unless noted    Interv Entry   Allowed           Disallowed   Limitations
         less noted    unless noted Max. /crop /year  otherwise)/A]    (days)  Interv                                 Codes
         otherwise)       otherwise) Dose cycle       /crop    /year         [day(s)]
                                                      cycle
HOG/PIG/SWINE  (MEAT)  (con't)

Animal treatment  (dust)., When  needed.,
Shaker can.
Animal treatment  (dust)., When  needed.,
Squeeze applicator.

Animal treatment  (ear)., When needed.,
Squeeze applicator.

Animal treatment  (spray)., When needed.
Sprayer.
Animal treatment  (wound)., When  needed.
Aerosol can.
Animal treatment  (wound)., When  needed.,
Sprayer.

Animal treatment  (wound)., When  needed.,      D     NA
Squeeze applicator.

Spray., When needed., Hand held  sprayer.      EC    NA
                               Use Group:  INDOOR FOOD (con't)

                       6.250E-04 Ib    *  NS     NS         NS
                             animal

                       6.250E-04 Ib    *  NS     NS         NS
                             animal

                                 UC    *  NS     NS         NS
                                 UC    *  NS     NS
WP
PRL
PRL
WP
NA
NA
NA
NA
UC
UC
UC
UC
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
14
AN
AN
14
NS
NS
NS
NS
                                 UC    *  NS     NS
                                                                            UC
                                                                                    NS    NS
                                                                                                     NS       NS    NS
                                                         C04,  G64,  S09(0)


                                                         C04,  S09(0)


                                                         C04,  G64,  309(03)


                                                         C04,  G64,  309(03)


                                                         C04,  S06


                                                         C04,  306

                                                         C04,  G64,  S09(0)


                                                         C04,  G64,  309(03)

                                                         C04,  S06


                                                         C04,  G64,  309(03)


                                                         C04,  C93,  FOB
SHEEP (MEAT)

Animal treatment  (dust)., When  needed.,
Squeeze applicator.

Animal treatment  (ear)., When needed.,
Squeeze applicator.

Animal treatment  (spray)., When needed.,
Sprayer.
                               Use Group:  INDOOR FOOD

                                 UC    *  NS     NS


                                 UC    *  NS     NS


                                 UC    *  NS     NS
NS      NS   AN
NS      NS   AN     NS
                                                           NS      NS   14     NS
C04,  G64, S09(3)


C04,  G64, S09(3)


C04,  S09(3)
SITE Application Type, Application
  Timing, Application Equipment
FOOD/FEED USES  (con't)
                  APPENDIX A   )   CASE 0018,  [Coumaphos]  Chemical 036501  [Coumaphos]

                        444444444444444444444444444444444444444444444444444444444444444444444,
Form(s)   Min. Appl.      Max. Appl. Soil Max.  tt  Apps  Max.  Dose [(AI   Min.  Restr.     Geographic Limitations      Use
         Rate (AI un-      Rate  (AI Tex. @ Max.  Rate  unless noted    Interv Entry   Allowed           Disallowed   Limitations
         less noted    unless noted Max. /crop /year  otherwise)/A]    (days)  Interv                                 Codes
         otherwise)      otherwise) Dose cycle       /crop    /year         [day(s)]
                                                      cycle
                                                                                             89

-------
SHEEP (MEAT)  (con't)

Animal treatment  (wound)., When needed.,
Aerosol can.

Animal treatment  (wound)., When needed.,
Sprayer.

Animal treatment  (wound)., When needed.,
Squeeze applicator.

Dip treatment., When needed., Vat.

NON-POOD/NON-FEED
                    Use Group: INDOOR FOOD  (con't)

                              UC   *  NS    NS


                              UC   *  NS    NS


                              UC   *  NS    NS


                              UC   *  NS    NS
                         NS      NS   AN     NS
                         NS      NS   14     NS
                         NS      NS   AN     NS
                                                       NS       NS    10      NS
                                                                          C04,  G64,  S09(3)


                                                                          C04,  S09(3)


                                                                          C04,  G64,  S09(3)


                                                                          C04,  S09(3)
GOATS (WOOL/ANGORA ANIMAL)

Animal treatment  (dust)., When needed.,
Squeeze applicator.

Animal treatment  (spray)., When needed.,
Sprayer.

Animal treatment  (wound)., When needed.,
Aerosol can.

Animal treatment  (wound)., When needed.,
Sprayer.

Animal treatment  (wound)., When needed.,
Squeeze applicator.

Dip treatment., When needed., Vat.

Ear treatment. Use code ATN., When needed.
Squeeze applicator.
D     NA


WP    NA

D     NA
                            Use Group: INDOOR NON-FOOD

                              UC   *  NS    NS         NS       NS    AN     NS
                              UC
                                      NS    NS
                              UC   *  NS    NS
                              UC   *  NS    NS
UC

UC
NS    NS

NS    NS
                                                       NS       NS    14
                                                                            NS
NS      NS   AN     NS


NS      NS   14     NS


NS      NS   AN     NS


NS      NS   10     NS

NS      NS   AN     NS
                                                                                                                C04, G64
                                                                                                                C04, G64
C04,  G64


C04

C04,  G64
                                                                                            90

-------
SITE Application Type, Application        Form(s)
  Timing, Application Equipment
NON-FOOD/NON-FEED (con't)
         APPENDIX A  )  CASE 0018,  [Coumaphos]  Chemical  036501  [Coumaphos]

        444
Min. Appl.       Max. Appl.  Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations      Use
Rate (AI un-      Rate  (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed           Disallowed   Limitations
less noted    unless noted Max. /crop /year otherwise)/A]   (days) Interv                                 Codes
otherwise)       otherwise)  Dose cycle       /crop    /year          [day(s)]
                                            cycle
HORSES (SHOW/RACE/SPECIAL/PONIES)

Animal treatment  (dust)., When needed.,
Mechanical duster.

Animal treatment  (dust)., When needed., Not
on label.

Animal treatment  (dust)., When needed.,
Shaker can.
Animal treatment  (dust)., When needed.,
Squeeze applicator.

Animal treatment  (ear)., When needed.,
Squeeze applicator.

Animal treatment  (spray)., When needed.,
High pressure sprayer.

Animal treatment  (spray)., When needed.,
Sprayer.
Animal treatment  (wound)., When needed.,
Aerosol can.

Animal treatment  (wound)., When needed.,
Sprayer.
Animal treatment  (wound)., When needed.,
Squeeze applicator.

Dip treatment.,  When needed.,  Vat.

Spray., When needed., Hand held sprayer.
                      Use Group: INDOOR NON-FOOD
D
D
D
D
D
D
F1C
EC
F1C
WP
PRL
EC
WP
D
F1C
EC
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
.001 Ib animal
.001 Ib animal
.001 Ib animal
.001 Ib animal
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
UC
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
14
AN
AN
AN
14
AN
14
14
AN
AN
14
AN
10
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C04, G64
C04, G64
C04, G64
C04, G64
C04, G64
C04, G64

C04

C04
C04, G64
C04
C04
C04, G64

C04, C93
                                                                                            91

-------
SITE Application Type, Application
  Timing, Application Equipment
NON-FOOD/NON-FEED  (con't)
                                                             APPENDIX A  )   CASE 0018,  [Coumaphos]  Chemical 036501 [Coumaphos]
Form(s)   Min. Appl.
         Rate (AI un-
Max. Appl. Soil Max. # Apps Max. Dose  [(AI   Min.  Restr.     Geographic Limitations      Use
  Rate (AI Tex. @ Max. Rate unless noted    Interv Entry   Allowed           Disallowed   Limitations
                                                   less noted    unless noted Max.  /crop  /year  otherwise)/A]    (days)  Interv
                                                   otherwise)      otherwise) Dose  cycle
                                                     /crop    /year
                                                     cycle
                                                    [day(s)]
                                                                                                                                                              Codes
SHEEP (con't)

Animal treatment  (dust)., When needed.,
Squeeze applicator.

Animal treatment  (ear)., When needed.,
Squeeze applicator.

Animal treatment  (spray)., When needed.,
Sprayer.

Animal treatment  (wound)., When needed.,
Aerosol can.

Animal treatment  (wound)., When needed.,
Sprayer.

Animal treatment  (wound)., When needed.,
Squeeze applicator.

Dip treatment.,  When needed., Vat.
                               Use Group: INDOOR NON-FOOD  (con't)
                                 UC   *  NS    NS
                                 UC   *  NS    NS
                                 UC   *  NS    NS
                                                                           UC    *  NS     NS
                                                                                          C04, G64



                                                                                          C04, G64



                                                                                          C04



                                                                                          C04, G64



                                                                                          C04



                                                                                          C04, G64
                                                                                            92

-------
LEGEND
444444
                                                            APPENDIX A  )  CASE 0018,  [Coumaphos] Chemical  036501  [Coumaphos]
  HEADER ABBREVIATIONS
  Min. Appl.  Rate (AI unless :  Minimum dose for a single application to a single site.  System calculated.  Microbial claims only.
  noted otherwise)
  Max. Appl.  Rate (AI unless :  Maximum dose for a single application to a single site.  System calculated.
  noted otherwise)
                             :  Maximum dose for a single application to a single site as related to soil texture  (Herbicide claims only).
                             :  Maximum number of Applications at Maximum Dosage Rate.  Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
                               years" is expressed as "4/3 yr"
                             :  Maximum dose applied to a site over a single crop cycle or year.  System calculated.
Soil Tex.  Max.  Dose
Max. # Apps © Max. Rate
Max. Dose [ (AI unless
noted otherwise) /A]
Min. Interv (days)
                               Minimum Interval between Applications  (days)
  Restr. Entry Interv (days) :  Restricted Entry Interval (days)
  PRO Report Date
                             LUIS contains all products that were active or suspended  (and that were available from OPP Document Center) as of this date.  Some products
                             registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
                             data that has been captured.
  SOIL TEXTURE FOR MAX APP.  RATE
            Non-specific
  C         Coarse
  M         Medium
  F         Fine
  O         Others

  FORMULATION CODES
  D         DUST
  EC        EMULSIFIABLE CONCENTRATE
  F1C       FLOWABLE CONCENTRATE
  PRL       PRESSURIZED LIQUID
  RTU       LIQUID-READY TO USE
  WP        WETTABLE POWDER
  ABBREVIATIONS
  AN
  NA
  NS
  UC
          As Needed
          Not Applicable
          Not Specified (on label)
          Unconverted due to lack of data  (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
          briquets,  bursts,  cake, can, canister, capsule, cartridges,  coil,  collar, container, dispenser, drop, eartag, grains, lure, pack, packet,  packets, pad, part,
          parts, pellets,  piece, pieces, pill, pumps, sec, sec burst,  sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
  APPLICATION RATE
  DCNC
  No Calc
  W
  V
  U
  cwt
  nnE-xx
          Dosage Can Not be Calculated
          No Calculation can be made
          PPM calculated by weight
          PPM Calculated by volume
          Unknown whether PPM is given by weight or by volume
          Hundred Weight
          nn times (10 power -xx); for instance,  "1.234E-04"
                                                                is equivalent to ".0001234"
                                                                                           93

-------
                                                          APPENDIX A  )  CASE 0018,  [Coumaphos] Chemical 036501  [Coumaphos]
USE LIMITATIONS CODES
C04
C93
F01
F04
FOB
F06
G64
S06
S09
Proper ventilation required.
Do not apply directly to water.
	 day(s) prefreshening interval.
Prefreshening and/or premilking interval not located on label.
Do not apply to lactating animals.
	 day(s) premilking interval.
Avoid contamination of feed, feed containers and watering troughs.
Preslaughter interval not located on the label.
	 day(s) preslaughter interval.
  NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.)  DESCRIBED IN THE LIMITATION.
                                                                                         94

-------
                              GUIDE TO APPENDIX B

   Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the  case coumaphos  covered by this Reregi strati on  Eligibility  Decision
Document. It contains generic  data requirements that apply to coumaphos  in all products,
including data requirements for which a "typical formulation" is the test substance.

   The data table is organized in the following format:

   1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158.  the reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.

   2. Use Pattern (Column 2). This column indicates  the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:

             A   Terrestrial food
             B   Terrestrial feed
             C   Terrestrial non-food
             D   Aquatic food
             E   Aquatic non-food outdoor
             F   Aquatic non-food industrial
             G   Aquatic non-food residential
             H   Greenhouse food
             I    Greenhouse non-food
             J    Forestry
             K   Residential
             L   Indoor food
             M  Indoor non-food
             N   Indoor medical
             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.
                                         95

-------
Page Intentionally Blank
             96

-------
                                       APPENDIX B
           Data Supporting Guideline Requirements for the Reregistration of Coumaphos
REQUIREMENT
                                               USE PATTERN
             CITATION(S)
PRODUCT CHEMISTRY
61-1        Chemical Identity
61-2A      Start. Mat. & Mnfg. Process
61-2B      Formation of Impurities
62-1        Preliminary Analysis
62-2        Certification of limits
62-3        Analytical Method

63-2        Color
63-3        Physical State
63-4        Odor
63-5        Melting Point
63-6        Boiling Point
63-7        Density
63-8        Solubility
63-9        Vapor Pressure
63-10      Dissociation Constant
63-11      Octanol/Water Partition
63-12      pH
All
All
All
All
All
All

All
All
All
All
All
All
All
All
All
All
All
CSFs dated 6/22/93
00110596, 41778501, 42378501, 42557001
00110596,41778501, 42378501
00110596, 42258601, 42675001, 42675003
CSFs dated 10/20/93
00110596, 41778501, 42258602, 42258603,
42378502, 42675002, 43115802
00110596
00021999,00110596
00110596
00021999,00110596
00021981
00110596
00110596,41778502
00005193
Waived
41778502
00110596
                                                  97

-------
Data Supporting Guideline Requirements for the Reregistration of Coumaphos
REQUIREMENT
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
USE PATTERN
All
All
All
All
All
All
All
All
CITATION(S)
00021981, 00141225, 41778502, 42378503,
43115801
Waived
N/A
Itr. dtd. 10/28/93
42378503
N/A
N/A
Data gap
ECOLOGICAL EFFECTS
71-1A
71-1B
71-2A
71-2B
71-3
71-4A
71-4B
71-5A
71-5B
72-1A
Acute Avian Oral - Quail/Duck
TGAI
Acute Avian Oral - Quail/Duck
TEP
Avian Dietary - Quail
Avian Dietary - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Simulated Field Study
Actual Field Study
Fish Toxicity Bluegill - TGAI
A
A
A
A
N/A
A
A
N/A
N/A
A
00112841,00160000
N/A
00112842,00022923
00112843,00022923
N/A
Waived
Waived
N/A
N/A
00112840,40098001
                                 98

-------
           Data Supporting Guideline Requirements for the Reregistration of Coumaphos
REQUIREMENT
72-1B
72-1C
72-1D
72-2A
72-2B
72-3A
72-3B
72-3C
72-3D
72-3E
72-3F
72-4A
72-4B
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout- TEP
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Estuarine/Marine Toxicity Fish-
TEP
Estuarine/Marine Toxicity
Mollusk - TEP
Estuarine/Marine Toxicity Shrimp
-TEP
Early Life Stage Fish
Life Cycle Invertebrate
USE PATTERN
A
A
N/A
A
N/A
A
A
A
N/A
N/A
N/A
A
A
CITATION(S)
N/A
00112840,40098001
N/A
40098001, 41778503, 41778504, 05009242
N/A
40228401
40228401
40228401
N/A
N/A
N/A
43066301
43116601
TOXICOLOGY
81-1
Acute Oral Toxicity - Rat
All
00110597, 00110603, 00112832, 00110609,
00112827,00112821, 00026376, 00026377,
00026379, 00026371
                                                99

-------
           Data Supporting Guideline Requirements for the Reregistration of Coumaphos
REQUIREMENT
                                                USE PATTERN
              CITATION(S)
81-2       Acute Dermal Toxicity -
           Rabbit/Rat
81-3       Acute Inhalation Toxicity - Rat

81-4       Primary Eye Irritation - Rabbit

81-5       Primary Dermal Irritation -
           Rabbit
81-6       Dermal Sensitization - Guinea Pig

81-7       Acute Delayed Neurotoxicity - Hen
81-8-SS    Acute Neurotoxicity - mammal
82-1A      90-Day Feeding - Rodent
82-1B      90-Day Feeding - Non-rodent
82-2       21-Day Dermal - Rabbit/Rat
82-3       90-Day Dermal - Rodent
82-4       90-Day Inhalation - Rat
82-5A      90-Day Neurotoxicity - Hen
82-5B      90-Day Neurotoxicity - Mammal
83-1A      Chronic Feeding Toxicity - Rodent
83-1B      Chronic Feeding Toxicity - Non-
           Rodent
83-2A      Oncogenicity - Rat
 All

 All

 All

 All

 All

 All
 All
  L
  L
  L
 N/A
 N/A
 N/A
 All
 All
  L

  L
100
00110598,00110604,00112833,00112816,
00112827,00112822,00026375,00026378,
00026372
00110601, 00110607, 00112836, 00112820,
00112830, 00112825,00026374
00110599,00110605,00112834,00112818,
00112828, 00112824, 00026370
00110600,00110605, 00112835, 00112817,
00112829, 00112823, 00026373
00110602,00110608,00112837,00112819,
00112831, 00112826, 00082524
00115167
00126527
00126527
N/A
00117106, 42084901, 42666401
N/A
N/A
N/A
Data gap
40836001,40955801
43055301

40836001,40955801

-------
           Data Supporting Guideline Requirements for the Reregistration of Coumaphos
REQUIREMENT USE
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
85-2
86-1
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
Dermal Penetration
Domestic Animal Safety
PATTERN
L
L
L
L
L
L
L
L
N/A
K
CITATION(S)
05009938
00131684
00131683
43061701
00131680
41847501, 42254501
00131681
00138596
N/A
00138251
OCCUPATIONAL/RESIDENTIAL EXPOSURE
231
232
233
234
Estimation of Dermal Exposure at
Outdoor Sites
Estimation of Inhalation Exposure
at Outdoor Sites
Estimation of Dermal Exposure at
Indoor Sites
Estimation of Inhalation Exposure
A
A
L
L
Data gap
Data gap
Data gap
Data gap
          at Indoor Sites

ENVIRONMENTAL FATE
161-1
Hydrolysis
A
Data gap partially satisfied by: 00150197,
00159928
                                               101

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            Data Supporting Guideline Requirements for the Reregistration of Coumaphos
REQUIREMENT
                                                 USE PATTERN
                                                        CITATION(S)
161-2
Photodegradation - Water
161-3      Photodegradation - Soil
161-4      Photodegradation - Air
162-1      Aerobic Soil Metabolism

162-2      Anaerobic Soil Metabolism
162-3      Anaerobic Aquatic Metabolism
162-4      Aerobic Aquatic Metabolism
163-1      Leaching/Adsorption/Desorption

163-2      Volatility - Lab
163-3      Volatility - Field
164-1      Terrestrial Field Dissipation
164-2      Aquatic Field Dissipation
164-5      Long Term Soil Dissipation
165-4      Bioaccumulation in Fish

165-5      Bioaccumulation - Aquatic
           NonTarget
166-1      Ground Water - Small Prospective
166-2      Ground Water - Small
           Retrospective
 A

N/A
N/A
 A

 A
 A
N/A
 A

N/A
N/A
 A
N/A
N/A
 A

N/A

N/A
 A
Data gap partially satisfied by: 42764101,
43103901,430022101
N/A
N/A
Data gap partially satisfied by: 0115165,
40518701
WAIVED FOR 162-3 STUDY
Data gap
N/A
Data gap partially satisfied by: 00163806,
42084092, 42097401
N/A
N/A
Data gap partially satisfied by: 00115166
N/A
N/A
N/A, however data are available in: 00115168,
00115169,00150619
N/A

N/A
Data gap partially satisfied by: No MRID:
JHJ;05/03/93
                                                    102

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Data Supporting Guideline Requirements for the Reregistration of Coumaphos
REQUIREMENT
RESIDUE
171-4A
171-4B

171-4C

171-4D

171-4E



171-4F

171-4J






CHEMISTRY
Nature of Residue - Plants
Nature of Residue - Livestock

Residue Analytical Method -
Plants
Residue Analytical Method -
Animal
Storage Stability



Magnitude of Residues - Potable
H2O
Magnitude of Residues -
Meat/Milk/Poultry/Egg





USE PATTERN CITATION(S)

N/A N/A
A 00005392, 00005402, 05004087, 05004483,
05012748, 42097402, 42323402
N/A N/A

A 00005195, 00005289, 00005342, 00005438,
42097403, 42323401, 43123401
A 00005341, 00073248, 43569801, 43569802,
43569803, 43569804, 43569805, 43569806,
43569807, 43569808, 43569809, 43569810,
43569811,43569812
N/A N/A

A 00005042, 00005047, 00005048, 00005051,
00005056, 00005074, 00005080, 00005081,
00005235, 00005293, 00005295, 00005330,
00005331, 00005333, 00005339, 00005399,
00005400, 00005479, 00005489, 00005493,
00005510, 00005822, 00005830, 00021731,
00021732, 00060807
                                 103

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Page Intentionally Blank
           104

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                               GUIDE TO APPENDIX C

1.  CONTENTS  OF  BIBLIOGRAPHY.  This bibliography contains  citations  of all studies
   considered relevant by EPA in arriving at the positions and  conclusions stated elsewhere in the
   Reregistration Eligibility Document. Primary sources for studies in this bibliography have been
   the body of data submitted to EPA and its predecessor agencies in support of past regulatory
   decisions.  Selections from  other sources including the published literature, in those instances
   where they have been considered, are included.

2.  UNITS OF ENTRY. The unit of entry in this bibliography is called a "study".  In the case of
   published materials, this corresponds closely to an article. In the case of unpublished materials
   submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
   published  article from within the typically larger volumes in which they were submitted.  The
   resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
   purposes of review  and can be described with a conventional  bibliographic citation. The Agency
   has also attempted to unite basic documents and commentaries upon them, treating them as a
   single study.

3.  IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
   Master Record Identifier, or "MRID number". This number is unique to the citation, and should
   be used whenever  a specific reference is required.  It is not related to the six-digit "Accession
   Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
   below for further explanation).  In a few cases, entries  added to the bibliography late in the
   review may be preceded by a nine character temporary identifier.  These entries are listed after
   all MRID entries.  This temporary identifying number  is also to be used whenever specific
   reference is needed.

4.  FORM OF ENTRY.  In addition to the Master Record Identifier (MRID), each entry consists
   of a citation containing standard elements followed, in the case of material submitted to EPA,
   by a description of the earliest known submission.  Bibliographic conventions used reflect the
   standard of the American National  Standards Institute (ANSI), expanded to provide for certain
   special needs.

   a.  Author. Whenever the author could confidently be identified, the Agency has chosen to
       show  a personal author.  When no individual was identified,  the Agency  has shown an
       identifiable laboratory  or testing facility as the author. When no author or laboratory could
       be identified, the Agency  has shown the first submitter as the author.

   b.  Document date. The date of the study is taken directly from the document.  When the date
       is followed by  a question mark, the bibliographer has deduced the date from the evidence
       contained in the  document. When the date appears as (19??), the Agency  was unable to
       determine or estimate the date of the document.

   c.  Title.   In  some cases, it  has been necessary for the Agency bibliographers to create or
       enhance a document title.  Any such editorial insertions are  contained between square
       brackets.
                                           105

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d.  Trailing parentheses.  For studies  submitted to the Agency in the  past, the  trailing
   parentheses include (in addition to any self-explanatory  text) the following elements
   describing the earliest known submission:

   (1) Submission date.  The date of the earliest known submission appears immediately
       following the word "received."

   (2) Administrative number. The next element immediately following the word "under" is
       the registration number, experimental use permit number, petition number, or other
       administrative number associated with the earliest known submission.

   (3) Submitter.  The third element is the submitter.  When authorship is defaulted to the
       submitter, this element is omitted.

   (4) Volume Identification (Accession Numbers).   The  final  element  in the  trailing
       parentheses identifies the EPA accession number of the volume in which the original
       submission of the study appears. The six-digit accession number follows the symbol
       "CDL," which stands for "Company Data Library." This accession number is in turn
       followed by an alphabetic suffix which shows the relative position of the study within
       the volume.
                                      106

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                              BIBLIOGRAPHY

MRID                        CITATION
00005042  Chemagro Corporation (1971) Chemagro Corporation Residue Experiment Nos. AH
          70G-810, AH 71G-818: Report No. 30331. (Unpublished study received Oct 29,
          1971 under 11556-4; submitted by Bayvet, Shawnee Mission, Kans.; CDL:010122-F)

00005047  Chemagro Corporation  (1967) Chemagro Corporation Residue Experiment No.
          KC-201-66D: Report No. 20652. (Unpublished study received Dec 15, 1967 under
          11556-19; submitted by Bayvet, Shawnee Mission, Kans.; CDL:014008-D)

00005048  Chemagro Corporation  (1967) Chemagro Corporation Residue Experiment No.
          KC-300-66H: Report No. 20964. (Unpublished study received Dec 15, 1967 under
          11556-19; submitted by Bayvet, Shawnee Mission, Kans.; CDL:014008-E)

00005051  Chemagro Corporation (1968)  Chemagro Corporation Residue Experiment No. ?:
          Report No. 23942.  (Unpublished study received Jul 23, 1970 under 11556-16;
          submitted by Bayvet, Shawnee  Mission, Kans.; CDL:007188-A)

00005056  Chemagro Corporation  (1963) Chemagro Corporation Residue Experiment No.
          KC-215-63D: Report No. 12541. (Unpublished study including letter dated Jan 22,
          1964 from G.G. Stetson  to G.M. Downard, received  Jan 28, 1964 under 11556-21;
          submitted by Bayvet, Shawnee  Mission, Kans.; CDL:025715-A)

00005074  Anderson, C.A.  (1959) Co-Ral  Residues  in Goat Tissues:  Report No.  4008.
          (Unpublished study received Sep 11, 1959 under 1155621; prepared by Chemagro
          Corp., submitted by Bayvet, Shawnee Mission, Kans.; CDL:011001-A)

00005080  Chemagro Corporation (1969) Synopsis of Analytical and Residue Information for
          Spray Application of Co-Ral to Dairy Cattle. Summary of studies 006078-B through
          006078-G. (Unpublished study received Feb 20, 1970 under 11556-21; submitted by
          Bayvet, Shawnee Mission, Kans.; CDL:006078-A)

00005081  Chemagro Corporation  (1969) Chemagro Corporation Residue Experiment No.
          KC-201-68D: Report No. 24216. (Unpublished study received Feb 20, 1970 under
          11556-21; submitted by Bayvet, Shawnee Mission, Kans.; CDL:006078-G)

00005193  Chemagro Corporation (1957) Co-Ral (Formerly Bayer 21/199) for Experimental Use
          Only. (Unpublished study received Jul 1, 1957 under unknown admin, no.;  submitted
          by Bayvet, Shawnee Mission, Kans.; CDL:124847-A)

00005195  Anderson, C.A. (1958) A Photofluorometric Method for the Determination  of Co-Ral
          (Bayer 21/199) Residues in Animal Tissues: Report No. 2216. Method dated Aug 13,
          1958.  (Unpublished study received Feb 27, 1976 under 11556-EX-3; prepared by
          Chemagro Corp., submitted by  Bayvet, Shawnee Mission, Kans.; CDL: 224167-E)
                                      107

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                              BIBLIOGRAPHY

MRID                        CITATION
00005235  Chemagro Corporation  (1964) Chemagro Corporation Residue Experiment No.
          KC-214-63D: Report No. 12786. (Unpublished study received Jun 8, 1964 under
          11556-25; submitted by Bayvet, Shawnee Mission, Kans.; CDL:102326-B)

00005289  Adams, J. (1964) A Quantitative Method for the Determination of Residues of Co-Ral
          (0-(3-Chioro-4-methyl umbelliferone) 0,0 Diethyl phosphorothioate) and Chlorferron
          (3-Chloro-4-methyl-7hydroxycoumarin) in Animal Tissues and Milk: Report No.
          13656. Method dated May 6, 1964. (Unpublished study received Aug 18, 1966 under
          7F0612; submitted by Chemagro Corp., Kansas City, Mo.; CDL:090796-K)

00005293  Chemagro Corporation  (1966) Chemagro Corporation Residue Experiment No.
          KC-3400-66D: ReportNo. 17971. (Unpublished study received Aug 18, 1966 under
          7F0612; CDL:090796-Q)

00005295  Chemagro Corporation  (1966) Chemagro Corporation Residue Experiment No.
          KC-3401-66H: ReportNo. 18522. (Unpublished study received Aug 18, 1966 under
          7F0612; CDL:090796-S)

00005330  Chemagro Corporation  (1963) Chemagro Corporation Residue Experiment No.
          KC-201-63D: Report No. 10923. (Unpublished study received on unknown date
          under PP0306; CDL:090321-D)

00005331  Chemagro Corporation (1961?) Synopsis of Analytical and Residue Information on
          Co-Ral: (Milk).  Summary of studies 090321-F through 090321-H. (Unpublished
          study received Sep 4, 1961 under PP0306; CDL:090321-E)

00005333  Chemagro Corporation (1960) Residue Report: ReportNo. 5515. (Unpublished  study
          including report nos.  5533  and 5534,  received Sep  4, 1961 under  PP0306;
          CDL: 090321-H)

00005338  Chemagro Corporation (1966) Synopsis of Analytical and Residue Information for
          Dust  Application to Cattle.   Summary  of studies 092586-B, 092586-D through
          092586-E and 092586-G. (Unpublished study  including supplement, received Mar
          18, 1968 under 1F0306;  CDL:092586-A)

00005339  Chemagro Corporation  (1967) Chemagro Corporation Residue Experiment No.
          KC-201-67D: ReportNo. 20599. (Unpublished study including report nos. 20651,
          20663 and 20677, received Mar 18,  1968 under 1F0306; CDL:092586-B)

00005341  Chemagro Corporation (1963) The  Effect of Storage on CoRal Residues in Milk:
          ReportNo. 11212.  (Unpublished study received on unknown date under 1F0306;
          CDL:092586-F)
                                      108

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                              BIBLIOGRAPHY

MRID                        CITATION
00005342  Adams, J.M. (1963) A Quantitative Method for the Determination of Residues of
          Co-Ral (O-(3-Chloro-4-methyl umbelliferone) O,O Diethyl phosphorothioate) and
          Chlorferron (3-Chloro-4-methyl-7 hydroxycoumarin) in Animal Tissues and Milk:
          Report No. 7165. Rev. (pp. 1-6 only; unpublished study received on unknown date
          under 1F0306; submitted by Chemagro Corp., Kansas City, Mo.; CDL:092586-G)

00005392  Chemagro Corporation (1959) Synopsis of Metabolic, Analytical, Residue, and Taste
          Data on Co-Ral.  Summary of studies 090326-B through 090326-U. (Unpublished
          study received Oct 8, 1959 under 1F0306; CDL:090326-A)

00005399  Gronberg,  R.R.  (1958)  Co-Ral Residues  in  Cattle  Tissue: Report No.  2556.
          (Unpublished study received Oct 8, 1959 under 1F0306; prepared in cooperation with
          Science Service Laboratory, Livestock Insect Section, submitted by Chemagro Corp.,
          Kansas City, Mo.; CDL:090326-I)

00005400  Anderson,  C.A.  (1959)  Co-Ral Residues in Hog Tissues: Report No.  4009.
          (Unpublished study received Oct 8,  1959 under 1F0306; submitted by Chemagro
          Corp., Kansas City, Mo.;  CDL:090326-O)

00005402  Robbins, W.E.; Hopkins, T.L.; Darrow, D.I.; Eddy, G.W.  (1959)  Studies with
          Phosphorus 32 Bayer 21/199 sprayed on cattle.  Journal  of Economic Entomology
          52(2):214-217. (Report no. 4168; also submitted under 1F0306).

00005479  Gronberg,  R.R.  (1958)  Co-Ral Residues  in Cattle Tissues: Report No.  2409.
          (Unpublished study including report no. 2447a, received Feb 14, 1961 under PP0299;
          prepared in cooperation with U.S. Dept. of Agriculture, submitted by Chemagro
          Corp., Kansas City, Mo.;  CDL:090320-AH)

00005489  Chemagro  Corporation (1963)  Chemagro  Corporation  Residue Experiment No.
          EC-212-62D: Report No. 11358. (Unpublished study received Feb 11, 1964 under
          PP0299; CDL:090319-AA)

00005493  Chemagro Corporation (1961) Chemagro Corporation Residue Experiment No. ?:
          Report No. 7167. (Unpublished study received on unknown  date under PP0229;
          CDL:092579-C)

00005510  Chemagro Corporation (1968) Recovery of Co-Ral from Milk: Report No. 22697.
          (Unpublished study received Feb 20, 1970 under 11556-21; submitted by Bayvet,
          Shawnee Mission, Kans.; CDL:  102084-E)

00005822  Chemagro  Corporation (1963)  Chemagro  Corporation  Residue Experiment No.
          KC-203-63D: Report No. 11449.  (Unpublished study received Jul 9, 1963  under
          11556-21; submitted by Bayvet, Shawnee Mission, Kans.; CDL:025716-A)

                                       109

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                              BIBLIOGRAPHY

MRID                        CITATION
00005830  Chemagro  Corporation (1964) Chemagro Corporation  Residue Experiment No.
          KC-200-64D: Report No. 13875.  (Unpublished study received Jun 4, 1965 under
          11556-16; submitted by Bayvet, Shawnee Mission, Kans.; CDL:126094-B)

00021731  Chemagro  Corporation (1966) Chemagro Corporation  Residue Experiment No.
          KC-201-67D: Report No. 19,351. (Unpublished study received on unknown date
          under PP0306; CDL:098412-F)

00021732  Chemagro  Corporation (1966) Chemagro Corporation  Residue Experiment No.
          KC-200-67D: Report No. 19,234. (Unpublished study received on unknown date
          under PP0306; CDL:098412-G)

00021981  Chemagro Corporation (1964) Co-Ral Parasiticide.  (Unpublished study received Oct
          8, 1968 under unknown admin, no.; submitted by Mobay Chemical Corp., Kansas
          City, Mo.; CDL:006897-A)

00022923  Hill, E.F.;Heath, R.G.; Spann, J.W.; et al.  (1975) Lethal Dietary Toxicity  of
          Environmental Pollutants to Birds: special Scientific report—Wildlife No. 191. (U.S.
          Fish and Wildlife Service, Patuxent Wildlife Research Center; unpublished report).

00021999  Coberly, R.D.  (19??)  Co-ral:  0,0-Diethyl-0-(3-chloro-4-methyl-7 coumarinyl)
          phosphorothioate. (Unpublished study received Oct 8, 1968 under unknown admin.
          no.; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:006897-AI)

00026370  Shmidl, J.A.; Kohlenberg, M.L. (1979) Eye Irritation Evaluation for Bay Vb 9328
          Flowable: Report No. 70643. (Unpublished study received Jan 4, 1980 under
          11556-98; submitted by Bayvet, Shawnee Mission, Kans.; CDL:241573-D)

00026371  Shmidl, J.A.; Kohlenberg, M.L.  (1979) Oral LD50 Evaluation for Bay Vb 9328
          Flowable 50% in Rats: Report No.  70714.  (Unpublished study received Jan 4, 1980
          under 11556-98; submitted by Bayvet, Shawnee Mission, Kans; CDL:241573-E)

00026372  Shmidl, J.A.; Kohlenberg, M.L. (1979) Dermal LD50 Evaluation for Bay Vb 9328
          Flowable in Rabbits: Report No. 70838. (Unpublished study received Jan 4, 1980
          under 11556-98; submitted by Bayvet, Shawnee Mission, Kans.; CDL:241573-F)

00026373  Shmidl, J.A.; Kohlenberg, M.L. (1979) Primary Dermal Irritation Evaluation for Bay
          Vb 9328 Flowable: Report No. 70988.  (Unpublished study received Jan 4, 1980
          under 11556-98; submitted by Bayvet, Shawnee Mission, Kans.; CDL:241573-G)
                                       110

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                              BIBLIOGRAPHY

MRID                        CITATION
00026374  Nelson, D.L. (1979) Bay Vb 9328 50% Flowable Acute Inhalation Toxicity to Rats:
          Report No. 71091. (Unpublished study including submitting company summary,
          received Jan 4, 1980 under 1155698; prepared by Mobay Chemical Corp., submitted
          by Bayvet, Shawnee Mission, Kans.; CDL:241573-H)

00026375  Shmidl, J.A.; Kohlenberg, M.L.; Hiley, C.A. (1979) Dermal LD50 Evaluation for Bay
          Vb 9328, Lot No. R76-17-109 in Male Rabbits: Report No. 71181.  (Unpublished
          study received Jan 4, 1980 under 11556-98; submitted by Bayvet, Shawnee Mission,
          Kans.; CDL: 241573-1)

00026376  Shmidl, J.A.; Hiley, C.A.; Kohlenberg, M.L. (1979) Oral LD50 Evaluation for Bay
          Vb 9328  Flowable, Lot No.  R76-17-109, in Female Rats:  Report No.  71190.
          (Unpublished study received Jan 4,  1980 under 11556-98; submitted by Bayvet,
          Shawnee Mission, Kans.; CDL:241573-J)

00026377  Shmidl, J.A.; Hiley, C.A.; Kohlenberg, M.L. (1979) Oral LD50 Evaluation for Bay
          Vb 9328  Flowable, Lot No.  C76-17-151, in Female Rats:  Report No.  71289.
          (Unpublished study received Jan 4,  1980 under 11556-98; submitted by Bayvet,
          Shawnee Mission, Kans.; CDL:241573-K)

00026378  Shmidl, J.A.; Hiley, C.A.; Kohlenberg, M.L. (1979) Dermal LD50 Evaluation for Bay
          Vb 9328  Flowable, Lot No. C76-17-151,  in Male  Rabbits: Report No.  71352.
          (Unpublished study received Jan 4,  1980 under 11556-98; submitted by Bayvet,
          Shawnee Mission, Kans.; CDL:241573-L)

00026379  Shmidl, J.A.; Kohlenberg,  M.L. (1979) Oral LD50 Evaluation  for Bay Vb 9328
          Flowable, Lot No. C76-17-151, in Male Rats:  Report No. 71395.  (Unpublished study
          received Jan 4, 1980 under 11556-98; submitted by Bayvet, Shawnee Mission, Kans.;
          CDL:241573-M)

00060807  Anderson,  C.A.  (1959) Co-ral Residues in  Sheep Tissues: Report No.  3665.
          (Unpublished study including letter dated Apr 16, 1959 from G.M. Williams to R.D.
          Radeleff, received Apr 21,  1959 under 11556-21; prepared by  Chemagro Corp.,
          submitted by Bayvet Shawnee Mission, Kans.; CDL: 124731-A, 124742)

00073248  Mobay Chemical  Corporation (1967) Synopsis of Analytical and Residue Information
          for Dust Application to Cattle.  (Compilation; unpublished study received Dec 15,
          1967 under 3125-209; CDL: 102328-A)

00082524  Hixson, E.J.; Delphia, K.L.; Lamb, D.W.; et al. (1980) Dermal Sensitization of Bay
          Vb 9328 Flowable: Report No. 71898. (Unpublished study received Oct 20, 1981
          under 11556-98;  submitted by Bayvet, Shawnee Mission, Kans.; CDL:246071-A)
                                       111

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                              BIBLIOGRAPHY

MRID                        CITATION
00110596 Bayvet (1981) Product Chemistry: Coumaphos.  (Compilation; unpublished study
         received on unknown date under 11556-4; CDL: 248200-A)

00110597 Shmidl, 1; Rainey, L.; Kohlenberg, M. (1981) Oral LD50 Evaluation for Coumaphos
         Compound: Report No. 72212.  (Unpublished study received on unknown date under
         11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-B)

00110598 Shmidl,  J.;  Kohlenberg, M.; Rainey, L. (1981) Dermal LD50 Evaluation for
         Coumaphos Technical Compound: Report No. 72216. (Unpublished study received
         on unknown date under  11556-4; submitted by Bayvet,  Shawnee Mission, KS;
         CDL:248200-C)

00110599 Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Eye Irritation Evaluation for
         Coumaphos Technical in Rabbits: Report No. 72213. (Unpublished study received
         on unknown date under  11556-4; submitted by Bayvet,  Shawnee Mission, KS;
         CDL:248200-D)

00110600 Shmidl,  J.;  Kohlenberg, M.; Rainey, L. (1981)  Primary Dermal  Irritancy  of
         Coumaphos Technical to Rabbits: Report No. 72205. (Unpublished study received
         on unknown date under  11556-4; submitted by Bayvet,  Shawnee Mission, KS;
         CDL:248200-E)

00110601 Sangha, G.; De Jong, M.; Lamb, D.; et al. (1982) Acute Inhalation Toxicity Study
         with Coumaphos Technical in Rats:  Study No. 81041-14, Report  No.  72398.
         (Unpublished study received on unknown date under 11556-4; submitted by Bayvet,
         Shawnee Mission, KS; CDL:248200-F)

00110602 Shmidl, J.; Kohlenberg, M.; Hess, L.  (1982) Dermal Sensitization Evaluation of
         Coumaphos Technical  in Guinea Pigs: Report No. 72452.  (Unpublished study
         received on unknown date under 11556-4; submitted  by Bayvet, Shawnee Mission,
         KS; CDL:248200-G)

00110603 Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Oral LD50 Evaluation for Co-Ral 25%
         Wettable Powder: Report No. 72207.  (Unpublished study received on unknown date
         under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-H)

00110604 Shmidl, J.; Kohlenberg, M.; Rainey, L.  (1980) Dermal LD50 Evaluation for Co-Ral
         25% Wettable Powder in Rabbits: Report No. 71804. (Unpublished study received
         on unknown date under  11556-4; submitted by Bayvet,  Shawnee Mission, KS;
         CDL:248200-I)
                                      112

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                              BIBLIOGRAPHY

MRID                        CITATION
00110605  Shmidl, I; Kohlenberg, M.; Rainey, L. (1980) Eye Irritation Evaluation for Co-Ral
          5% Wettable Powder: Report No. 71755. (Unpublished study received on unknown
          date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-J)

00110606  Shmidl, 1; Kohlenberg, M.; Rainey, L. (1980) Primary Dermal Irritation Evaluation
          for Co-Ral 25% Wettable Powder: Report No. 71756.  (Unpublished study received
          on unknown date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:
          248200-K)

00110607  Sangha, G.;  De Jong, M.; Lamb, D.; et al. (1982) Acute Inhalation Toxicity Study
          with Co-Ral 25% Wettable Powder in Rats:  Study No. 81-041-15; Report No. 72404.
          (Unpublished study received on unknown date under 11556-4; submitted by Bayvet,
          Shawnee Mission, KS; CDL:248200-L)

00110608  Shmidl, I; Kohlenberg, M.; Rainey, L. (1982) Dermal Sensitization Evaluation for
          Co-Ral 25% Wettable Powder in Guinea Pigs: Report No. 72453.  (Unpublished
          study received on unknown date under 11556-4; submitted by Bayvet,  Shawnee
          Mission, KS; CDL:248200-M)

00110609  Shmidl, 1; Kohlenberg, M.; Rainey, L. (1980) Oral LD50 Evaluation for Co-Ral 1%
          Dust: Report No. 71802.  (Unpublished  study received on unknown date under
          11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-N)

00112816  Shmidl, 1; Kohlenberg, M.; Rainey, L. (1980) Dermal LD50 Evaluation for Co-Ral
          1% Dust in Rabbits: Report No.  71825. (Unpublished study received on unknown
          date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-O)

00112817  Shmidl, 1; Kohlenberg, M.; Rainey, L. (1981) Primary Dermal Irritation Evaluation
          for Co-Ral 1% Dust: Report No. 71944. (Unpublished study received on unknown
          date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-P)

00112818  Shmidl, I; Rainey, L.; Kohlenberg, M. (1981) Eye Irritation Evaluation for Co-Ral
          1% Dust: Report No. 71945. (Unpublished study received on unknown date under
          11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-Q)

00112819  Shmidl, I; Kohlenberg, M.; Rainey, L. (1982) Dermal Sensitization Evaluation for
          Co-Ral 1% Dust in Guinea Pigs: Report No. 72331. (Unpublished study received on
          unknown date under 11556-4;  submitted  by  Bayvet, Shawnee Mission, KS;
          CDL:248200-R)
                                       113

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                              BIBLIOGRAPHY

MRID                        CITATION
00112820  Sangha, G.; De Jong, M.; Lamb, D. (1982) Acute Inhalation Toxicity Study with
          Co-Ral 1% Dust in Rats: Study No. 81-041-17; Report No. 72397. (Unpublished
          study received on unknown date under 11556-4; submitted by Bayvet, Shawnee
          Mission, KS; CDL:248200-S)

00112821  Shmidl, 1; Kohlenberg, M.; Rainey, L. (1981) Oral LD50 Evaluation for Co-Ral 3%
          Spray  Foam: Report No. 72106.  (Unpublished study received on unknown date
          under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-T)

00112822  Shmidl, I; Rainey, L.; Kohlenberg, M. (1981) Dermal LD50  for CoRal 3% Spray
          Foam: Report No. 72110.  (Unpublished study received on unknown date under
          11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-U)

00112823  Shmidl, 1; Rainey, L.; Kohlenberg, M. (1981) Primary Dermal Irritation Evaluation
          for Co-Ral 3%  Spray Foam: Report No. 72102. (Unpublished study received on
          unknown  date  under  11556-4;  submitted by Bayvet,  Shawnee Mission, KS;
          CDL:248200-V)

00112824  Shmidl, I; Rainey, L.; Kohlenberg, M. (1981) Eye Irritation Evaluation for Co-Ral
          3% Spray Foam: Report No. 72191. (Unpublished study received on unknown date
          under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-W)

00112825  Sangha, G.; Lamb, D.; Mallicoat, D.; et al. (1981) Acute Inhalation Toxicity of
          Co-Ral 3% Spray Foam Wound Treatment: Study No. 81-041-05; Report No. 72323.
          (Unpublished study received on unknown date under 11556-4; submitted by Bayvet,
          Shawnee Mission, KS; CDL:248200-X)

00112826  Shmidl, J.; Kohlenberg, M.; Hess, L. (1982) Dermal Sensitization Evaluation for
          Co-Ral 3% Spray Foam Concentrate in  Guinea Pigs:  Report No.  72455.
          (Unpublished study received on unknown date under 11556-4; submitted by Bayvet,
          Shawnee Mission, KS; CDL: 248200-Y)

00112827  Shmidl, J.; Rainey, L.; Kohlenberg, M. (1981) Oral LD50 Evaluation for Co-Ral 4%
          Pour-on: Report No. 72229. (Unpublished study received on unknown date under
          11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-Z)

00112828  Shmidl, J.; Rainey, L.; Kohlenberg, M. (1980) Eye Irritation Evaluation  for 4%
          Co-Ral Pour-on:  Report No. 71634. (Unpublished study received on unknown date
          under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-AB)

00112829  Shmidl, J.; Kohlenberg, M.; Rainey, L. (1980) Primary Dermal Irritation Evaluation
          for Co-Ral Pour-on: Report No. 71635.  (Unpublished study received on unknown
          date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-AC)

                                       114

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                              BIBLIOGRAPHY

MRID                        CITATION
00112830  Sangha, G.; Lamb, D.; Mallicoat, D.; et al. (1982) Acute Inhalation Toxicity Study
          with  Co-Ral 4% Pour-on in Rats: Study No.  81-041-18; Report No.  72403.
          (Unpublished study received on unknown date under 11556-4; submitted by Bayvet,
          Shawnee Mission, KS; CDL:248200-AD)

00112831  Shmidl, I; Kohlenberg, M.; Rainey, L. (1982) Dermal Sensitization Evaluation for
          Co-Ral 4% Pour-on in Guinea Pigs: Report No. 72454. (Unpublished study received
          on unknown date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:
          248200-AE)

00112832  Shmidl, I; Rainey, L.; Kohlenberg, M. (1981) Oral LD50 Evaluation for Co-Ral
          Emulsifiable Livestock Insecticide: Report No. 72228. (Unpublished study received
          on unknown date under 11556-4;  submitted  by Bayvet,  Shawnee Mission,  KS;
          CDL:248200-AF)

00112833  Shmidl, J.; Kohlenberg, M.; Rainey, L. (1982) Dermal LD50 Evaluation for Co-Ral
          E.L.I, in Rabbits: Report No. 72328.  (Unpublished study received on unknown date
          under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-AG)

00112834  Shmidl, J.; Kohlenberg, M.; Rainey, L. (1981) Eye Irritation Evaluation for Co-Ral
          11.6% ELI in Rabbits: Report No. 72101. (Unpublished study received on unknown
          date under 11556-4; submitted by Bayvet, Shawnee Mission, KS; CDL:248200-AH)

00112835  Shmidl, J.; Kohlenberg, M.; Rainey,  L. (1981) Primary Dermal Irritation for Co-Ral
          11.6% Emulsifiable Livestock Insecticide: Report No. 72100.  (Unpublished study
          received on unknown date under 11556-4; submitted by Bayvet, Shawnee Mission,
          KS; CDL: 248200-AI)

00112836  Shmidl, J.; Kohlenberg, M.; Rainey, L. (1982) Dermal Sensitization Evaluation for
          Co-Ral 11.6% Emulsifiable Livestock Insecticide in Guinea Pigs: Report No. 72332.
          (Unpublished study received on unknown date under 11556-4; submitted by Bayvet,
          Shawnee Mission, KS; CDL:248200-AJ)

00112837  Sangha, G.; Grocki, T.; Lamb, D.; et al. (1982) Acute Inhalation Toxicity Study with
          Co-Ral Emulsifiable Livestock Insecticide in Rats: Study No. 81-041-16; Report No.
          72402. (Unpublished study received on unknown date under 11556-4; submitted by
          Bayvet, Shawnee Mission, KS; CDL:248200-AK)

00112840  Lamb, D.; Roney, D. (1980) Coumaphos Technical Acute Toxicity to Bluegill and
          Rainbow  Trout:  Study Nos. 79AAB05  and  79AAR06; Report  No.  71615.
          (Unpublished study received on unknown date under 11556-4; submitted by Bayvet,
          Shawnee Mission, KS; CDL: 248200-AN)
                                       115

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                              BIBLIOGRAPHY

MRID                        CITATION
00112841  Carlisle, I; Carsel, M.; Lamb, D.; et al. (1982) Acute Oral LD50 of Coumaphos to
          Bobwhite Quail: Study No. 82-015-02; Report No. 72396.  (Unpublished study
          received on unknown date under 11556-4; submitted by Bayvet, Shawnee Mission,
          KS; CDL: 248200-AO)

00112842  Carlisle, I; Carsel, M.; Lamb, D.; et al. (1982) Acute Dietary LC50 of Coumaphos
          Technical to Bobwhite Quail: Study No. 82-17502; Report No. 72424. (Unpublished
          study received on unknown date under 11556-4; submitted by Bayvet,  Shawnee
          Mission, KS; CDL:248200-AP)

00112843  Carlisle, I; Carsel, M.; Lamb, D.; et al. (1982) Acute Dietary LC50 of Coumaphos
          Technical to Mallard Duck: Study No. 82-17501; Report No. 72409. (Unpublished
          study received on unknown date under 11556-4; submitted by Bayvet,  Shawnee
          Mission, KS; CDL:248200-AQ)

00115165  Fox, S.; Pollock, R. (1980) Soil Metabolism Study of Coumaphos: ADC Project
          #490-C;  71859.  Final  rept.  (Unpublished study  received Sep 23, 1982 under
          11556-11;  prepared by  Analytical Development Corp.,  submitted by Bayvet,
          Shawnee Mission, KS; CDL:248395-A)

00115166  Shmidl, I; Kohlenberg, M.; Rainey, L.; et al. (1981) Determination of the Rate of
          Disappearance of Coumaphos in Soil: Report No. 72226.  (Unpublished study
          received Sep 23, 1982 under 11556-11; submitted by Bayvet, Shawnee Mission, KS;
          CDL: 248396-A)

00115167  Kruckenberg,  S.  (1981)  Acute Delayed Neurotoxicity  of Coumaphos in
          Hens-81-Chicken-02: Submitter 72206.  (Unpublished study received Sep 23, 1982
          under 11556-11; prepared by Kansas State Univ., Veterinary Medical Center, Dept.
          of Pathology, submitted by Bayvet, Shawnee Mission, KS; CDL:248397-A)

00115168  Lamb, D.;  Roney, D. (1980) Coumaphos-14C Accumulation and Persistence of
          Residues in Bluegill: Report No. 87; 71632.  (Unpublished study received Sep 23,
          1982 under 11556-11; prepared by Mobay Chemical Corp., submitted by Bayvet,
          Shawnee Mission, KS; CDL: 248398-A)

00115169  Kruckenberg, S. (1981) Acute Single Dose Oral  LD50  Study  on Coumaphos
          Technical—Si-Chicken-01: Submitter 72183.  (Unpublished study received Sep 23,
          1982 under 11556-11; prepared by Kansas State Univ., Veterinary Medical Center,
          Dept. of Pathology, submitted by Bayvet, Shawnee Mission, KS; CDL:248399-A)
                                       116

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MRID                        CITATION
00117106  Shmidl, I; Hess, L.; Kohlenberg, M. (1982) Subchronic 21-day Dermal Toxicity
          Study Conducted in Rabbits for a Coumaphos Flowable Formulation: Report No.
          72462. (Unpublished study received Oct 1, 1982 under 11556-98; submitted  by
          Bayvet, Shawnee Mission, KS; CDL:248450-A)

00126527  Porter, M.; Jasty, V.; Bare, I; et al. (1983) Subchronic (13 Week) Oral Toxicity
          Evaluation of Coumaphos in the Rat: Bayvet Report No. 72586.  (Unpublished study
          received Mar 21,  1983 under 11556-11; prepared  in cooperation  with Miles
          Laboratories, submitted by Bayvet, Shawnee Mission, KS; CDL:249746-A)

00131680  Herbold, B.; Lorke, D. (1981) Asuntol-Salmonella/Microsome Test To Investigate
          the Point-mutagenic Effect: Pharma Report No. 10188; 72321.  (Unpublished study
          received Oct 18, 1983 under 11556-11; prepared by Bayer AG, W.  Ger.,  submitted
          by Bayvet, Shawnee Mission, KS; CDL:251532-A)

00131681  Herbold,  B.; Lorke, D. (1983) Asuntol-Pol Al Test on  Escherichia coli  To
          Investigate DNA-damaging Effects: Pharmaceutical Report No. 11689 (E); 72688.
          (Unpublished study received Oct 18, 1983 under 11556-11; prepared by Bayer AG,
          W. Ger., submitted by Bayvet, Shawnee Mission, KS; CDL:251532-B)

00131683  Clemens,  G.; Hartnagel,  R. (1983)  Study of the Toxicity  of Coumaphos:  II.
          Teratology (Segment II) Study in the Rabbit: Report No. 6; 72642. (Unpublished
          study received Oct 18, 1983 under 11556-11; prepared by Miles Laboratories, Inc.,
          submitted by Bayvet, Shawnee Mission, KS; CDL:251532-D)

00131684  Clemens,  G.; Hartnagel, R.  (1983) Study of the Toxicity  of Coumaphos: III.
          Teratology (Segment II) Study in the Rat: Report No. 8; 72754.  (Unpublished study
          received Oct 18,  1983 under 11556-11; prepared by  Miles Laboratories, Inc.,
          submitted by Bayvet, Shawnee Mission, KS; CDL:251532-E)

00138251  Kohlenberg, M.; Barker, L.;  Shmidl, J. (1984) Safety Evaluation for the Use of
          Coumaphos Flowable on Horses: Bayvet Report No. 72829.  (Unpublished study
          received Feb 23, 1984 under 1155698; submitted by Bayvet, Shawnee Mission, KS;
          CDL:252989-A)

00138596  Leeling, J.; Ryerson, B.; Helms, R.  (1983)  General  Metabolism Studies with
          Coumaphos 14C in the Rat: Submitter Report No. 72821.   (Unpublished study
          received Jan 26,  1984 under 11556-11; prepared by  Miles Laboratories, Inc.,
          submitted by Bayvet, Shawnee Mission, KS; CDL:252274-A)

00141225  Campbell, L., Gay, J. (1984) Stability of Coumaphos Grade 1. Unpublished study
          prepared by Bayvet Div. Miles Laboratories, Inc. 7 p.
                                       117

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00150197 Mallet, V.; Volpe, Y. (1978) Degradation of Coumaphos in distilled water as function
          of pH. Analytica Chimica Acta 97:415-418.

00150619 Waggoner, T. (1985) Inclusion of Additional Data to Coumaphos-C14 Accumulation
          and Persistence of Residues in Bluegill: Bayvet Report No. 71632.  Unpublished
          study prepared by Bayvet Division of Miles Laboratories, Inc. 4 p.

00159928 Waggoner, T. (1986) Hydrolysis of Carbon  14 Coumaphos in  Sterile Buffered
          Aqueous  Solutions:  Report  No.  73320.    Unpublished study  prepared  by
          Pharmacology and Toxicology Research Laboratory. 118 p.

00160000 Hudson, R.; Haegele, M. (1984) Handbook of Toxicity of Pesticides to Wildlife:
          Second Edition, U.S. Fish and Wildlife Service: resource Publication 153. 91 p.

00163806 Waggoner, T. (1986) Leaching of Aged Residues  of Carbon 14-Coumaphos in Soil:
          Mobay Report No. 73431.   Unpublished  study prepared  by Pharmacology  &
          Toxicology Research  Laboratory.  51 p.

05004087 Krueger, H.R.; Casida,  I.E.; Niedermeier, R.P. (1959)  Bovine metabolism  of
          organophosphorus insecticides, Metabolism and residues associated with dermal
          application of Co-Ral to  rats, a goat, and a cow.  Journal of Agricultural and Food
          Chemistry 7(3): 182-188.

05004483 Kaplanis, J.N.; Hopkins,  D.E.; Treiber,  G.H. (1959) Dermal and oral treatments of
          cattle with phosphorus-32-labeled  Co-Ral. Journal of Agricultural and  Food
          Chemistry 7(7):483-486.

05009242 Sanders, H.O. (1969)  Toxicity of Pesticides to the Crustacean Gammarus lacustris.
          Washington, D.C.: U.S.  Bureau of Sport Fisheries and Wildlife.  (U.S. Bureau of
          Sport Fisheries and Wildlife technical paper.) 25 p.

05009938 National   Cancer  Institute  (1979)  Bioassay  of  Coumaphos   for  Possible
          Carcinogen!city. Washington, D.C.: United States Department of Health, Education
          and Welfare, Public Health Service. (NCI Carcinogenesis technical report series no.
          96; DHEW publication no. (NIH) 79-1346)

05012748 Kasimov,  D.D. (1969) Metabolism  of ko-rala v organizme krolikov  i krupnogo
          rogatogo skota. Co-Ral metabolism in  rabbits and  cattle.  Trudy, VVsesoyuznyi
          Naucholssledovatel'skii  Institut Veterinarnoi  Sanitarrii.  transactions, all-union
          Scientific Research Institute of Veterinary Sanitation. 32:379-387.
                                        118

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MRID                        CITATION
40098001  Mayer, F.;Ellerseick, M. (1986) Manual of Acute Toxicity: Interpretation and Data
          Base 410 Chemicals and 66 Species of Freshwater Animals.  U.S. Fish and Wildlife
          Service; Resource Publication (160): 579 p. EPA/600/X-86/231.

40228401  Duplicate of MRID 40098001, ADP record deleted.

40518701  Olson, G.; Lawrence, L. (1987) Coumaphos-Aerobic Soil Metabolism Study: PTRL
          Project No. 113.  Unpublished study prepared by Pharmacology and Toxicology
          Research Laboratory. 49 p.

40836001  Eiben, R. (1988) Coumaphos:  Studies on Chronic Toxicity  and Carcinogenicity in
          Wistar Rats: Administration with Feed for 24 Months: Report No. 17131:  Study No.
          T2020064.  Unpublished Mobay study 73797 prepared by Bayer AG Institute of
          Toxicology. 2252 p.

40955801  Eiben,  R.;  Finn,  J.  (1988)  Coumaphos: Studies on  Chronic Toxicity  and
          Carcinogenicity in Wistar Rats (Administration with Feed for 24 Months): Report No.
          73797: Study No. T2020064.  Unpublished study prepared by Bayer AG, Institute of
          Toxicology. 19 p.

41778501  Rose, W. (1990) Co-Ral 25% Dust Base (Coumaphos): Lab Project Number: 74114;
          74115.  Unpublished study prepared by Mobay Corp. 77 p.

41778502  Rose, W. (1990) Product Chemistry of Coumaphos Technical Grade 1: Lab Project
          Number: 74111; 74113; 72899.  Unpublished study prepared by Mobay Corporation.
          98 p.

41778503  Waggoner, T. (1990) Coumaphos-Acute LC50 Freshwater Invertebrate: Lab Project
          Number:  COUM90A1.   Unpublished  study  prepared  by M.C. Bowman  and
          Associates.  60 p.

41778504  Waggoner, T. (1990) Coumaphos—Acute LC50 Freshwater Invertebrate (Gammarus
          lacustris): Lab Project Number: COUM90C: COUM90C1. Unpublished study
          prepared by M. C. Bowman  and Associates. 46 p.

41847501  Putman, D. (1991) Micronucleus Cytogenetic Assay in Mice: Coumaphos Technical:
          Lab Project Number: T9423/122. Unpublished study prepared by Microbiological
          Associates, Inc. 36 p.

42084901  Sheets, L.; Phillips, S. (1991) Repeated Dose (21-Day) Dermal Toxicity Study with
          Technical Grade Coumaphos  in Rats: Lab Project Number: 91-122-IE. Unpublished
          study prepared by Mobay  Corp. 253 p.
                                       119

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MRID                        CITATION
42084902  Waggoner, T. (1991) Coumaphos: Adsorption/Desorption: Lab Project Number:
          COUM90E1.  Unpublished study prepared by M.C. Bowman and Associates. 88 p.

42097401  Waggoner, T. (1991)  Coumaphos:  Adsorption/Desorption of Two Degradation
          Products: Chlorferon andHOL-5461: Lab Project Number: COUM91E: COUM91D.
          Unpublished study prepared by M. C. Bownam and Associates. 101 p.

42097402  Waggoner, T. (1991) Coumaphos: Nature of the Residue: Lab Project Number:
          9014B. Unpublished study prepared by Southwest BioLabs, Inc.  138 p.

42097403  Waggoner, T.  (1991) Coumaphos: Residue Analytical Methods: Lab Project Number:
          MOB AY-MR-1: MOBAY-MR-1A. Unpublished study prepared by M. C. Bowman
          and Associates. 86 p.

42254501  Goethem, D. (1992) Micronucleus Cytogenetic Assay in Mice: Lab Project Number:
          T9423.122. Unpublished study prepared by Microbiological Associates, Inc.  9 p.

42258601  Basel, C. (1992) Analysis of Five Lots of Co-Ral 25 Percent Dust Base and Five Lots
          of Coumaphos Technical: Lab Project Number: 92-624-009. ..127. Unpublished study
          prepared by Miles, Inc.  29 p.

42258602  Basel, C.  (1992)  Validation of Test Method TMC-2. 54 for Determining Ethyl
          Sulfotepp in  Coumaphos  Technical and Co-Ral 25 Percent  Dust Base/Wettable
          Powder: Lab Project Number: 92-618-015...23: 92-624-009...50. Unpublished study
          prepared by Miles, Inc.  28 p.

42258603  Heizelman, B. (1992) Validation of Test Method TMC-2. 03 for the Determination
          of Chlorferone Ethyl Ester, Potasan, Coumaphos, and Other Unidentified  Substances
          Associated with Coumaphos in Co-Ral  25 Percent Dust Base/Wettable Powder and
          in Coumaphos Technical by Reverse High Performance Liquid Chromatography: Lab
          Project Number: 92-618-016...023: 92-619-035...130. Unpublished study prepared
          by Miles, Inc. 46 p.

42323401  Waggoner, T.  (1992) Coumaphos: Residue Chemistry: Residue  Analytical Methods:
          Lab Project Number: COUM91H: COUM91H1. Unpublished study prepared by M.C.
          Bowman and  Associates and Miles, Inc. 74 p.

42323402  Waggoner, T. (1992) Coumaphos: Residue Chemistry: Nature of the Residue: Lab
          Project Number: 74311: COUM92E. Unpublished study prepared by M.C. Bowman
          and Associates and Miles,  Inc. 29 p.
                                       120

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42378501  Brannan, C. (1992) Supplemental Submission to MRID No. 417785-01: Product
          Identity and Composition of Coumaphos Technical Grade 1.  Unpublished study
          prepared by Miles Inc. 10 p.

42378502  Thomas, L. (1992) Progress Report on the Identification of Substances Associated
          with  Coumaphos in  Co-Ral 25% Dust Base/Wettable Powder and Coumaphos
          Technical: Lab Project Number: 92-618-016: 92-618-023: 92-619-035. Unpublished
          study prepared by Miles Inc. 25 p.

42378503  Brannan, C. (1992) Stability of Co-Ral 25(percent) Dust Base (24 Month Interval):
          Lab Project Number:  89-499-20.  Unpublished study prepared by Miles Inc. 7 p.

42512601  Judy, D.; Kaiser, F. (1992) Removal of Coumaphos Active Ingredient from Cattle
          Hides Treated with Co-Ral Emulsifiable Liquid Insecticide (E.L.I.): Lab Project
          Number: 40329. Unpublished study prepared by ABC Labs, Inc.  117 p.

42512602  Judy, D.; Kaiser, F. (1992) Removal of Coumaphos Active Ingredient from Cattle
          Hides Treated with Co-Ral 25% Wettable Powder Insecticide: Lab Project Number:
          40418.  Unpublished  study prepared by ABC Labs,  Inc. 112 p.

42512604  Corn, J.; Nettles, V. (1992) Coumaphos: Pilot Field Study to Evaluate Potential
          Toxicologic Effects in Wild Birds by Coumaphos Applications to Livestock: Lab
          Project Number:  SCWDS-001.  Unpublished  study  prepared by The Univ. of
          Georgia. 51 p.

42519101  Shmidl, J. (1992)  Progress Report: Special  Retrospective  Field Dissipation for
          Coumaphos Active Ingredient:  Lab Project Number: MCB-COUM-RETRO-1.
          Unpublished study prepared by M. C. Bowman Assoc. 382 p.

42557001  Shmidl, J. (1992) Co-Ral 25 percent Dust Base Formulation Process (Supplemental).
          Unpublished study prepared by Miles. Inc. 9 p.

42608601  Bowman, M.  (1992) Special Retrospective Field Dissipation Study for Coumaphos
          Active Ingredient: Interim Report: Part II (Soil from Round of Sampling): Lab Project
          Number: 74367-1. Unpublished study prepared by M.C. Bowman & Associates. 42
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42666401  Astroff, A. (1993) Repeated Dose (21 Day) Dermal Toxicity Study with Technical
          Grade Coumaphos in Rats: Supplemental To MRID 42084901: Lab Project Number:
          91-122-IE. Unpublished study prepared by Miles Inc.  20 p.
                                       121

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MRID                        CITATION
42675001  Basel, C. (1993) Identification of Three HPLC Peaks of Unknown  Impurities
          Associated with Coumaphos: Lab Project Number: 93-633-107: 74386. Unpublished
          study prepared by Bayer AG.  30 p.

42675002  Thomas, L. (1993) Validation of Test Method TMC-2.03 for the Determination of
          Coumaphos and its Impurities in Co-Ral 25% Dust Base/Wettable Powder and in
          Coumaphos Technical by High Performance Liquid Chromatography: Rev. Report:
          Lab Project Nos: 74286: 92-618-016: 92-619-035. Unpublished study prepared by
          Miles Inc. 58 p.

42675003  Thomas, L. (1993) Analysis  of 5 Lots of Co-Ral 25% Dust Base and 5 Lots of
          Coumaphos Technical:  Revised  Report:  Lab Project  Number:  92-624-009:
          92-619-035: 74284. Unpublished study prepared by Miles Inc. 40 p.

42764101  Dykes, J. (1993) Determination  of the Aqueous  Photodegradation of (carbon
          14)-Coumaphos: Revised Final Report: Lab Project Number: 1224: 1224-1: 74413.
          Unpublished study prepared by Analytical Development Corp.  81 p.

42764102  Dykes, J. (1993) Determination  of the Aqueous Photodegradation of Carbon
          14-Coumaphos: Addendum No. 1 to Revised Final Report: Lab Project Number:
          1224:  1-1224: 74413-1.  Unpublished study prepared by Analytical Development
          Corp.  9 p.

42920301  Dykes, J. (1993) Determination  of the Photodegradation of Carbon-14 Coumaphos
          on the  Surface of Soil: Lab Project Number: ADC 1223. Unpublished study prepared
          by Analytical Development Corporation.  82 p.

43022101  Kelley, L; Wood, S. (1993) Aqueous Photolysis of Coumaphos-Identification of the
          Main Degradate: A Study  to Supplement Miles Report 74413: Lab Project Number:
          106221: CS082401. Unpublished study prepared by Miles Inc. Agricultural Div. 43
          P-

43055301  Jones, R.; Elcock, L.; Dass, P.; et al. (1993) Chronic Feeding Toxicity Study of
          Technical Grade Coumaphos in Beagle Dogs:  Lab Project Number: 91-276-JP:
          74459. Unpublished study prepared by Miles, Inc.  1487 p.

43061701  Eigenberg, D.; Elcock, L. (1993) A Two-generation Dietary Reproduction Study in
          Rats Using Technical Grade Coumaphos: Lab Project Number: 91-672-JI: 74460.
          Unpublished study prepared by Miles, Inc. 1044 p.
                                       122

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43066301  Gagliano,   G.;   Bowers,   L.   (1993)  Early   Life   Stage  Toxicity   of
          (carbon-14)-Coumaphos to the  Rainbow Trout (Oncorhynchus mykiss) Under
          Flow-Through Conditions: Lab Project Number: 106245: CS842201. Unpublished
          study prepared by Miles Inc. 70 p.

43103901  Kelley, I; Wood, S. (1994) Aqueous Photolysis of Coumaphos-Identification of the
          Main Degradate: Lab Project Number: CS082401: 106221.  Unpublished study
          prepared by Miles Agricultural Division.  43 p.

43115801  Siemann, L. (1993) Product Chemistry for Coumaphos: Lab Project Number: 74462:
          3537-F. Unpublished study prepared by Midwest Research Institute. 29 p.

43115802  Mihalik, R.  (1993) Confirmation of Coumaphos  and  Impurity  Identifications
          Obtained Using the HPLC Method for Co-Ral 25% Dust Base and Coumaphos
          Technical Material: Lab Project Number: 74463: 93-624: 93-633.  Unpublished study
          prepared by Miles Animal Health Products. 32 p.

43123401  Bajzik, M. (1994) The Independent Laboratory Method Validation for the Analysis
          of Coumaphos and its Oxygen Analog in Meat and Milk: Lab  Project Number:
          A012.005: 74473. Unpublished study prepared by Huntingdon Analytical Services.
          102 p.

43167401  Dykes, J. (1994) Determination of the Photodegradation of (carbon 14)-Coumaphos
          on the Surface of Soil: Characterization of Bound Residues and Radioactivity Loss:
          Revision #1  to Final Research  Report:  Lab Project Number:  1223H-1: 74476.
          Unpublished  study prepared by Analytical Development Corp. 33 p.

43569801  Fought, L. (1994) Coumaphos  Residues in  Cattle Treated with CO-RAL 25%
          Wettable Powder: Revised: Lab Project Number: 10820: KC-212-62D. Unpublished
          study prepared by Miles, Inc. 7 p.

43569802  Fought, L. (1994) Coumaphos Residues in Cattle Exposed to a Backrubber Prepared
          from CO-RAL Emulsifiable Livestock Insecticide:  Revised: Lab Project Number:
          13912: KC-201-64D. Unpublished study prepared by Miles, Inc.  9 p.

43569803  Fought, L. (1994) Coumaphos Residues in the Milk of Cattle Treated with CO-RAL
          Emulsifiable  Livestock  Insecticide:  Revised:  Lab  Project  Number:  24050:
          KC-200-68D. Unpublished study prepared by Miles, Inc. 45 p.

43569804  Fought, L.  (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
          Emulsifiable  Livestock  Insecticide:  Revised:  Lab  Project  Number:  26083.
          Unpublished  study prepared by Miles, Inc. 13 p.
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                              BIBLIOGRAPHY

MRID                        CITATION
43569805  Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
          25% Wettable Powder: Revised: Lab Project Number: 26084.  Unpublished study
          prepared by Miles, Inc.  13 p.

43569806  Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
          Insecticide Pour-On: Revised:  Lab Project Number: 26107.  Unpublished study
          prepared by Miles, Inc.  13 p.

43569807  Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
          25%  Wettable Powder: Revised:  Lab  Project Number: 27484: AH-70A-743.
          Unpublished study prepared by Miles, Inc. 20 p.

43569808  Fought, L. (1994) Coumaphos Residues in the Fat of Cattle Treated with CO-RAL
          Insecticide Pour-On:  Revised:  Lab Project Number:  27486:  AH-70A-749.
          Unpublished study prepared by Miles, Inc. 13 p.

43569809  Fought, L. (1994)  Coumaphos Residues in the Fat of Cattle Dipped in  a 50%
          Formulation of CO-RAL Wettable Powder:  Revised: Lab Project Number: 40856:
          AH-74A-932.  Unpublished study prepared by Miles, Inc. 25 p.

43569810  Fought, L. (1994) Coumaphos Residues in the Tissues of Cattle Treated with a 3%
          Formulation of K.R.S. with CO-RAL Spray Foam Insecticide: Revised: Lab Project
          Number: 50836: TR-76A-116. Unpublished study prepared by Miles, Inc. 31 p.

43792201  Ellisor, G. (1995) Evaluation of Potential Worker Exposure to Coumaphos During the
          Mixing/Loading of CO-RAL Products: Lab Project Number: 107070. Unpublished
          study prepared by Bayer Corp.  80 p.
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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
CERTIFIED MAIL
Dear Sir or Madam:

   This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must respond
as set forth in Section III below. Your response must state:

   1.   How you will comply with the requirements set forth in this Notice and its Attachments 1
       through 7;  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
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice  in Attachment 2. All products are listed on both the generic
and product specific Data Call-In Response Forms.  Also included is a list of all registrants who
were sent this Notice (Attachment 5).

   The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 1 U.S.C. section 136a(c)(2)(B). Collection of this
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information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 3-31-96).

   This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:

Section I  -  Why You are Receiving this Notice
Section II -  Data Required by this Notice
Section III -  Compliance with Requirements of this Notice
Section IV -  Consequences of Failure to Comply with this Notice
Section V -  Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI -  Inquiries and Responses to this Notice

   The Attachments to this Notice are:

   1 - Data Call-In Chemical Status Sheet
   2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with
       Instructions (Form A)
   3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status and
       Registrant's Response Forms with Instructions (Form B)
   4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements
       for Reregi strati on
   5 - List of Registrants Receiving This Notice
   6 - Cost Share. Data Compensation Forms, and Confidential Statement of Formula
SECTIONI. WHY YOU ARE RECEIVING THIS NOTICE

   The Agency has reviewed existing data for this active ingredient(s) and reevaluated the data
needed to support continued registration of the subject active ingredient(s). This reevaluation
identified additional data necessary to assess the health and safety of the continued use of
products  containing this active ingredient(s). You have been sent this Notice because you have
product(s) containing the subject active ingredients.
SECTION II. DATA REQUIRED BY THIS NOTICE

II-A. DATA REQUIRED

   The data required by this Notice are specified in the Requirements Status and Registrant's
Response Forms: Attachment 3 (for both generic and product specific data requirements).
Depending on the results of the studies required in this Notice, additional studies/testing may be
required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA

   You are required to submit the data or otherwise satisfy the data requirements specified in
the Requirements Status and Registrant's Response Forms (Attachment 3) within the timeframes
provided.

II-C. TESTING PROTOCOL

   All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.

   These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).

   Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 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(c)(2)(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 any previous Data Call-In(sX or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III.   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

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   The appropriate responses initially required by this Notice for generic and product specific
data must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.

III-B.  OPTIONS FOR RESPONDING TO THE AGENCY

   1. Generic Data Requirements

   The options for responding to this Notice for generic data requirements are: (a) voluntary
cancellation, (b) delete  use(s), (c) claim generic data exemption, (d) agree to satisfy the generic
data requirements imposed by this Notice or (e) request a data waiver(s).

   A discussion of how to respond if you choose the Voluntary Cancellation option, the Delete
Use(s) option or the Generic Data Exemption option is presented below. A discussion of the
various options available for satisfying the generic data requirements of this Notice is contained
in Section III-C. A discussion of options relating to requests for data waivers is contained in
Section III-D.

   Two forms apply  to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, (contained in
Attachments 2 and 3, respectively).

   The Data Call-In Response Forms must be submitted as part of every response to this Notice.
The Requirements Status and Registrant's Response Forms also must be submitted if you do not
qualify for a Generic Data Exemption or are not requesting voluntary cancellation of your
registration(s). Please note that the company's authorized representative is required to sign the
first page of both Data  Call-In Response Forms and the Requirements Status and Registrant's
Response Forms (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 completed Generic and Product Specific Data
Call-In Response Forms (Attachment 2), indicating your election of this option. Voluntary
cancellation is item number 5 on both Data Call-In Response Form(sy If you choose this option,
these are the only  forms that you are required to complete.

   If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective  date of cancellation must be in accordance with the Existing Stocks provisions

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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 and Registrant's Response Form (Attachment 3), 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. You must also
complete a Data Call-In Response Form by signing the certification, item  number 8.
Application forms for amending registrations may be obtained from the Registration Support
Branch, Registration Division, Office of Pesticide Programs, EPA, by calling (703) 308-8358.

   If you choose to delete the use(s)  subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due date
of your 90 day response, is allowed only if the product bears an amended label.

   c.  Generic Data Exemption -

   Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is exempt from
the requirement to submit or cite generic data concerning an active ingredient if the active
ingredient in the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient. EPA has concluded, as an exercise of its discretion, that it
normally will not suspend the registration of a product which would qualify and continue to
qualify for the generic data exemption in  section 3(c)(2)(D) of FIFRA. To qualify, all of the
following requirements must be met:

   (i). The active ingredient in your registered product must be present solely because of
   incorporation of another registered product which contains the subject active ingredient and
   is purchased from a source 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 Form. Attachment 2 and all supporting documentation. The Generic Data Exemption
is item number 6a on the Data Call-In Response Form. If you claim a generic data exemption
you are not required to complete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option for responding to product specific data
requirements.

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   If you are granted a Generic Data Exemption, you rely on the efforts of other persons to
provide the Agency with the required data. If the registrant(s) who have committed to generate
and submit the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Data Call-In Notice, the Agency will consider that both they and you are
not compliance and will normally initiate proceedings to suspend the registrations of both your
and their product(s), unless you commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant a time extension for submitting
the data.

   d.  Satisfying the Generic Data Requirements of this Notice

   There are various options available to satisfy the generic data requirements of this Notice.
These options are discussed in Section III-C.l. of this Notice and comprise options 1  through 6
of item 9 in the instructions for the Requirements  Status  and Registrant's Response Form and
item 6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy the generic
data requirements), you must submit the Data Call-In Response Form and the Requirements
Status and Registrant's Response Form as well as any other information/data pertaining to the
option chosen to address the data requirement. Your response must be on the forms marked
"GENERIC"  in item number 3.

   e.  Request for Generic Data Waivers.

   Waivers for generic data are discussed in Section III-D.l. of this Notice and are covered by
options 8 and 9 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose one of these options, you  must submit both forms as well as any
other information/data pertaining to the option chosen to address the data requirement.

   2. Product Specific Data Requirements

   The options for responding to this Notice for product specific data are: (a) voluntary
cancellation,  (b) agree to satisfy the product specific data requirements imposed by this Notice
or (c) request a data waiver(s).

   A discussion of how to respond if you  choose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
requirements of this Notice is  contained in Section III-C.2. A discussion of options relating to
requests for data waivers is contained in Section III-D.2.

   Two forms apply to the product specific data requirements one or both of which must be
used in responding to the Agency,  depending upon your response. These forms are the
Data-Call-in Response Form,  and the Requirements Status and Registrant's Response Form, for
product specific data (contained in Attachments 2 and 3, respectively).  The Data Call-In
Response Form must be submitted as part  of every response to  this Notice.  In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Call-In Response Form unless the voluntary cancellation option
is selected.  Please note that the company's authorized representative is required to sign the first

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page of the Data Call-In Response Form and Requirements Status and Registrant's Response
Form (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 Form.
indicating your election of this option. Voluntary cancellation is item number 5 on both the
Generic and Product Specific Data Call-In Response Forms. 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.2. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product specific Data Call-In
Response Form. 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 Reregi strati on 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 Form.  If you choose this option,  you  must submit the Data Call-In Response Form
and the Requirements Status and Registrant's Response Form as well as any other
information/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.

III-C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

   1.  Generic Data
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   If you acknowledge on the Generic Data Call-In Response Form that you agree to satisfy the
generic data requirements (i.e. you select item number 6b), then you must select one of the six
options on the Generic Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:

   (1)1 will generate and  submit data within the specified timeframe (Developing Data)
   (2) I have entered into  an agreement with one or more registrants to develop data jointly
       (Cost Sharing)
   (3) I have made offers  to cost-share (Offers to Cost Share)
   (4) I am submitting an  existing study that has not been submitted previously to the Agency
       by anyone (Submitting an Existing Study)
   (5) I am submitting or  citing data to upgrade a study classified by EPA as partially
       acceptable and upgradeable (Upgrading a Study)
   (6) I am citing  an existing study that EPA has classified as acceptable or an existing study
       that has been submitted but not reviewed by the Agency (Citing an Existing Study)

Option 1. Developing Data

   If you choose to develop the required data it must be in conformance with Agency deadlines
and with  other Agency requirements as referenced herein and in the attachments. All data
generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40 CFR
Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be in
conformance with the requirements of PR Notice 86-5. In addition, certain studies require
Agency approval of test protocols in advance of study initiation.  Those studies for which a
protocol must be submitted have been identified in the Requirements Status and Registrant's
Response Form and/or footnotes to the form. If you wish to use a protocol which differs from
the options discussed in Section II-C of this Notice, you must submit a detailed description of
the proposed protocol and your reason for wishing to use it. The  Agency may choose to reject a
protocol not specified in Section II-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will not be a basis
for extending the deadline  for submission of data.

   A progress report must be submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other means to address that study requirement,
such as making an  offer to cost share or agreeing to share in the cost of developing that study.
This 90-day progress report must include the date the study was or will be initiated and, for
studies to be started within 12 months of commitment, the name  and address of the
laboratory(ies) or individuals who are or will be conducting the study.

   In addition, if the time  frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to

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generate or otherwise address the requirement for the study. In addition to the other information
specified in the preceding paragraph, at a minimum, a brief description of current activity on and
the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
   The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports or protocols.
The noted deadlines run from the date of the receipt of this Notice by the registrant. If the data
are not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).

   If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains.  The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only  in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.

Option 2. Agreement to Share in Cost to Develop Data

   If you choose to enter into an agreement to share in the cost of producing the required data
but will not be submitting the data yourself, you must provide the name of the registrant who
will be submitting the data. You must also provide EPA with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an agreement
and the other registrant's acceptance  of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the final
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides  that if the parties cannot resolve the  terms of the agreement they may resolve their
differences through binding arbitration.

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
request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements  of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it will
not suspend the registration of a product of a  registrant who has  in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other

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registrant(s) developing the data has refused to accept the offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to another
registrant (who has an obligation to submit data) to share in the burden of developing that data.
You must also submit to the Agency a completed EPA Form 8570-32, Certification of Offer to
Cost Share in the Development of Data, Attachment 7. In addition, you must demonstrate that
the other registrant to whom the offer was made has not accepted your offer to enter into a cost-
sharing agreement by including a copy of your offer and proof of the other registrant's receipt of
that offer (such as a certified mail receipt). Your offer must, in addition to anything else, offer to
share in the burden of producing the data upon terms to be agreed to or, failing agreement, to be
bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify
this offer. The other registrant must also inform EPA of its election of an option to develop and
submit the data required by this Notice by submitting a Data Call-In Response Form and a
Requirements Status and Registrant's Response Form committing to develop and submit the data
required by this Notice.

   In order for you to avoid suspension under this option, you may not withdraw your offer to
share in the burden of developing the  data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data  or for some other reason is subject to suspension, your registration as
well as that of the other registrant normally will be subject to initiation of suspension
proceedings, unless you  commit to submit, and do submit, the required data in the specified time
frame.  In such cases, the Agency generally will not grant a time extension for submitting the
data.

Option 4. Submitting an Existing Study

   If you choose to submit an existing study in response to this Notice, you must determine that
the study satisfies the requirements imposed by this Notice. You may only submit a study that
has not been previously submitted to the Agency or previously cited by anyone. Existing studies
are studies which predate issuance of this Notice. Do not use this option if you are submitting
data to upgrade a study. (See Option 5).

   You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.

   To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:

   a.   You must certify at the time that the existing study is  submitted that the raw data and
       specimens from the study are available for audit and review and you must identify where
       they are available. This must be done in accordance with the requirements of the Good
       Laboratory Practice (GLP) regulation, 40 CFRPart 160. As stated in 40 CFR 160.3 'Raw
       data' means any laboratory worksheets, records, memoranda, notes, or exact copies
       thereof, that are the result of original observations and activities of a study and are

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       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."

   b.  Health and safety studies completed after May 1984 also 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 submitting
       the existing study that such GLP information is available for post May 1984 studies by
       including an appropriate statement on or attached to the study signed by an authorized
       official or representative of the registrant.

   c.  You must certify that each study fulfills the acceptance criteria for the Guideline relevant
       to the study provided in the FIFRA Accelerated Reregi strati on 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 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.

   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 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.

Option 5. Upgrading a Study
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   If a study has been classified as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and determine if the requirement
is satisfied. If the Agency decides the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient, but upgradeable studies will
normally be classified as supplemental. However, it is important to note that not all studies
classified as supplemental are upgradeable. If you have questions regarding the classification of
a study or whether a study may be upgraded, call or write the contact person listed in
Attachment 1. If you submit data to upgrade an existing study you must satisfy or supply
information to correct all deficiencies in the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or corrected and why the study
should be rated  as acceptable to EPA. Your submission must also specify the MRID number(s)
of the study which you are attempting to upgrade and must be in conformance with PR Notice
86-5.

   Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded.

   This option also should be used to cite data that has been previously submitted to upgrade a
study, but has not yet been reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being upgraded.

   The criteria for submitting an existing study, as specified in Option 4 above, apply to all  data
submissions intended to upgrade studies. Additionally, your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria, as well  as a certification regarding protocol compliance with Agency
requirements.

Option 6. Citing Existing Studies

   If you choose to cite a study that has been previously submitted to EPA, that study must have
been previously classified by EPA as acceptable, or it must be a study which has not yet been
reviewed by the Agency. Acceptable toxicology studies generally will have been classified as
"core-guideline" or "core-minimum." For ecological effects studies, the classification generally
would be a rating of "core." For all other disciplines the classification would be "acceptable."
With respect to  any studies for which you wish to select this option, you must provide the MRID
number of the study you are citing and, if the study has been reviewed by the Agency, you must
provide the Agency's classification of the study.
   If you are citing a study of which you are not the original data submitter, you must submit a
completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.

   2. Product Specific Data
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   If you acknowledge on the product specific Data Call-In Response Form that you agree to
satisfy the product specific data requirements (i.e. you select option 7a or 7b), then you must
select one of the six options on the Requirements Status and Registrant's Response Form related
to data production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options  discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:

   (1)1 will generate and submit data within the specified time-frame (Developing Data)
   (2) I have entered into an agreement with one or more registrants to develop data jointly
       (Cost Sharing)
   (3) I have made offers to cost-share (Offers to Cost Share)
   (4) I am submitting an existing  study that has not been submitted previously to the Agency
       by anyone (Submitting  an Existing Study)
   (5) I am submitting or citing data to upgrade a study classified by EPA as partially
       acceptable and upgradeable (Upgrading a Study)
   (6) I am citing an existing study that EPA has classified as acceptable or an existing study
       that has been
       submitted but not reviewed by the Agency (Citing an Existing  Study)

Option 1. Developing Data — The requirements for developing product specific data are the
same as those described for generic data (see Section 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.l,
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.

Option 4. Submitting an Existing Study — The same requirements described for generic data (see
Section III.C.l.,  Option 4) apply to this option for product specific data.

Option 5. Upgrading a Study — The same requirements described for generic data (see Section
III.C.l., Option 5) apply to this option for product specific data.

Option 6. Citing Existing Studies — The same requirements described  for generic data (see

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Section III.C.l., Option 6) apply to this option for product specific data.

   Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (III.C.L), as appropriate.
III-D REQUESTS FOR DATA WAIVERS

   1.  Generic Data

   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 data
requirement(s) are not appropriate for your product.

   a.  Low Volume/Minor Use Waiver

   Option 8 under item 9 on the Requirements Status and Registrant's Response Form. Section
3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of requiring data for low
volume, minor use pesticides. In implementing this provision, EPA considers low volume
pesticides to be only those active ingredients whose total production volume for all pesticide
registrants is small. In determining whether to grant a low volume, minor use waiver, the
Agency will consider the extent, pattern and volume of use, the economic incentive to conduct
the testing, the importance of the pesticide, and the exposure and risk from use of the pesticide.
If an active ingredient is used for both high volume and low volume uses, a low volume
exemption will not be approved. If all uses of an active ingredient are low volume and the
combined volumes for all uses are also low, then an exemption may be granted, depending on
review of other information outlined below. An exemption will not be granted if any registrant
of the active ingredient elects to conduct the testing. Any registrant receiving a low volume
minor use waiver must remain within the sales figures in their forecast supporting the waiver
request in order to remain qualified for such waiver. If granted a waiver, a registrant will be
required, as a condition of the waiver, to submit annual sales reports. The Agency will respond
to requests for waivers in writing.

       To apply  for a low volume, minor use waiver, you must submit the following
   information, as applicable to your product(s), as part of your 90-day response to this Notice:

       (i).  Total company sales (pounds and dollars) of all registered product(s) 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.

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    (iii) Total direct production cost of product(s) containing the active ingredient by year
for the past five years. Include information on raw material cost, direct labor cost,
advertising, sales and marketing, and any other significant costs listed separately.

    (iv) Total indirect production cost (e.g. plant overhead, amortized plant and equipment)
charged to product(s) containing the active ingredient by year for the past five years. Exclude
all non-recurring costs that were directly related to the active ingredient, such as costs of
initial registration and any data development.

    (v) A list of each data requirement for which you seek a waiver. Indicate the type of
waiver sought and the estimated cost to you (listed separately for each data requirement and
associated test) of conducting the testing needed to fulfill each of these data requirements.

    (vi) A list of each data requirement for which you are not seeking any waiver and the
estimated cost to you (listed separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data requirements.

    (vii)  For each of the next ten years, a year-by-year forecast of company sales (pounds
and dollars) of the active ingredient, direct production costs of product(s) containing the
active ingredient (following the parameters in item 2 above), indirect production costs of
product(s) containing the active ingredient (following the parameters in item 3 above),  and
costs of data development pertaining to the active ingredient.

    (viii)  A description of the importance and unique benefits of the active ingredient to
users. Discuss the use patterns and the effectiveness of the active  ingredient relative to
registered alternative chemicals and non-chemical control strategies. Focus on benefits
unique to the active ingredient, providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then present the
reasoning used to derive your estimates.  To assist the Agency in determining the degree of
importance of the active ingredient in terms of its benefits, you should provide information
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
and on its persistence in the environment, and (d) description of its usefulness against a
pest(s) of public  health significance.

    Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume/minor use waiver will result in denial of the request for
a waiver.

b.  Request for Waiver of Data

    Option 9, under Item 9, on the Requirements Status and Registrant's Response Form.
This option may be used if you believe that a particular data requirement should not apply
because the requirement is inappropriate. You must submit a rationale explaining why you

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believe the data requirements should not apply. You also must submit the current label(s) of
your product(s) and, if a current copy of your Confidential Statement of Formula is not
already on file you must submit a current copy.

    You will be informed of the Agency's decision in writing. If the Agency determines that
the data requirements of this Notice are not appropriate to your product(s), you will not be
required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that the data are
required for your produces! you must choose a method of meeting the requirements of this
Notice within the time frame provided by this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.

2. Product Specific Data

    If you request a waiver for product specific data because  you believe it is inappropriate,
you must attach a complete justification for the request including technical reasons, data and
references to relevant EPA regulations, guidelines or policies. (Note: any supplemental data
must be submitted in the format required by PR Notice 86-5). This will be the only
opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option  chosen on the  product specific
Requirements Status and Registrant's Response Form. Product specific data requirements for
product chemistry, acute toxicity and efficacy (where appropriate) are required for all
products and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the due
date for the study in question. Waiver requests submitted without adequate supporting
rationale will be denied and the original due date will remain in force.
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SECTION IV.   CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A  NOTICE OF INTENT TO SUSPEND

   The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:

   1.  Failure to respond as required by this Notice within 90 days of your receipt of this
       Notice.

   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 in the cost of
       developing data and provided proof of the registrant's receipt of such offer or failure of a
       registrant on whom you rely for a generic data exemption either to:

       i.  Inform EPA of intent to develop and submit the data required by this Notice on a Data
       Call-In Response Form and a Requirements Status and Registrant's Response Form.

       ii. Fulfill the commitment to develop and submit the data as required by this Notice; or

       iii. Otherwise take appropriate steps to meet the requirements stated in this Notice,
       unless you commit to submit and do submit the required data in the specified time frame.

   9.  Failure to take any required or appropriate steps, not mentioned above, at any time
       following the issuance of this Notice.

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IV-B.  BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE

   The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:

   1)  EPA requirements specified in the Data Call-In Notice or other documents incorporated
   by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
   Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
   reporting of required studies. Such requirements include, but are not limited to, those relating
   to test material, test procedures, selection of species, number of animals, sex and distribution
   of animals, dose and  effect levels to be tested or attained, duration of test, and, as applicable,
   Good Laboratory Practices.

   2)  EPA requirements regarding the submission of protocols, including the incorporation of
   any changes required by the Agency following review.

   3)  EPA requirements regarding the reporting of data, including the manner of reporting, the
   completeness of results, and the adequacy of any required supporting (or raw) data,
   including, but not limited to, requirements referenced or included in this Notice or contained
   in PR 86-5. All studies must be submitted in the form  of a final report; a preliminary report
   will not be considered to fulfill the submission requirement.

IV-C  EXISTING STOCKS OF SUSPENDED  OR CANCELLED PRODUCTS

   EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent
with the purposes of the  Act.

   The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing  stocks of your product(s) which may
be suspended for failure  to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to  EPA that granting such  permission would be consistent with the Act.
You also must explain why an "existing stocks" provision is necessary, including a statement of
the quantity  of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden, the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.

   If you request a voluntary cancellation of your product(s) 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

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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
(Attachment 2)and completed Requirements  Status and Registrant's Response Forms
(Attachment 3), 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 Forms need be submitted.

   The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.

                                     Sincerely yours,
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                                     Lois Rossi, Division Director
                                     Special Review and
                                      Reregi strati on Division
Attachments
   The Attachments to this Notice are:

   1 - Data Call-In Chemical Status Sheet
   2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with
       Instructions
   3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status and
       Registrant's Response Forms with Instructions
   4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements
       for Reregi strati on
   5 - List of Registrants Receiving This Notice
   6 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
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COUMAPHOS DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

   You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing coumaphos.

   This Product Specific Data Call-In Chemical  Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of 0018.
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) a list of registrants receiving this DCI
(Attachment 5)  and (6)  the Cost Share and Data Compensation Forms in replying to this
coumaphos Product Specific Data Call-In (Attachment 6).  Instructions and guidance accompany
each form.

DATA REQUIRED BY THIS NOTICE

   The additional data requirements needed to  complete the database  for coumaphos are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on coumaphos 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 reregi strati on of all eligible coumaphos 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 Edward Setren at (703) 308-8166.

   All responses to this Notice for the Product Specific data requirements should be submitted
   to:
      Edward Setren
      Chemical Review Manager, Team 81
      Product Reregi strati on Branch
      Special Review and Reregi strati on Division (7508W)
      Office of Pesticide Programs
      U.S. Environmental Protection Agency
      Washington, D.C. 20460

      RE: Coumaphos
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COUMAPHOS DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

   You have been sent this Generic Data Call-In Notice because you have product(s) containing
coumaphos.

   This Generic Data Call-In Chemical Status Sheet contains an overview of data required by
this notice, and point of contact for inquiries pertaining to the reregi strati on of coumaphos. This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic
Data Call-In Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form
(Attachment 3), (4 ) a list of registrants receiving this DCI (Attachment 5), and (5) the Cost Share
and Data Compensation Forms in replying to this coumaphos Generic Data Call In (Attachment
6). Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

   The additional data requirements needed to complete the generic  database for coumaphos are
contained in the Requirements Status and Registrant's Response. Attachment 3.  The Agency has
concluded that additional product chemistry data on coumaphos  are  needed.  These data are
needed to fully complete the reregi strati on of all eligible coumaphos products.

INQUIRIES AND RESPONSES TO THIS NOTICE

   If you have any questions regarding the generic data requirements and procedures established
by this Notice, please contact Dennis McNeilly at (703) 308-8066.

   All responses to this Notice for the generic data requirements should be submitted to:

      Dennis McNeilly, Chemical Review Manager
      Reregi strati on Branch
       Special Review and Registration Division (7508W)
      Office of Pesticide Programs
      U.S. Environmental Protection Agency
      Washington, D.C.  20460
      RE: Coumaphos
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  Instructions For Completing The "Data Call-In Response Forms" For The Generic And
                             Product Specific Data Call-In
INTRODUCTION

   These instructions apply to the Generic and Product Specific "Data Call-In Response Forms" and
are to be used by registrants to respond to generic and product specific Data Call-Ins as part of
EPA's Reregi strati on Program under the Federal Insecticide, Fungicide, and Rodenticide Act. If
you are an end-use product registrant only and have been sent this DCI letter as part of a RED
document you have been sent just the product specific "Data Call-In Response Forms." Only
registrants responsible for generic data have been sent the generic data response form. The type
of Data Call-in (generic or product specific) is indicated in item number 3 ("Date and Type
of DCI") on each form.

   Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling out the
forms.

   EPA has developed these forms individually for each registrant, and has preprinted these forms
with a number of items. DO NOT use these forms for any other active ingredient.

   Items 1 through 4 have been preprinted on the form.  Items 5 through 7 must be completed by
the registrant as appropriate. Items 8 through 11 must be completed by  the registrant before
submitting a response to the Agency.

   The public reporting burden for this collection of information is estimated to average 15 minutes
per response, including time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to Chief, Information Policy Branch, Mail Code
2136, 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.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 1.    ON BOTH FORMS: This item identifies your company name, number and address.

Item 2.    ON BOTH FORMS: This item identifies the case number, case name, EPA chemical
          number and chemical name.

Item 3.    ON BOTH FORMS:   This item identifies the type of Data Call-In.  The date of
          issuance is date stamped.

Item 4.    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.

Item 5.    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.

Item 6a.   ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for generic
          data as indicated in Item 3 and you are eligible for a Generic Data Exemption for the
          chemical listed in Item 2 and used in the subject product. By electing this exemption,
          you agree to the terms and conditions of a Generic Data Exemption as  explained in the
          Data Call-In Notice.

       If you  are eligible for or claim a Generic  Data Exemption, enter the EPA registration
       Number of each registered source of that active ingredient that you use in your product.

       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 registered), you may not claim a Generic Data Exemption and you may
       not select this item.
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In

Item 6b.   ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for generic
          data as indicated in Item 3 and if you are agreeing to satisfy the generic data
          requirements of this Data Call-In. Attach the Requirements Status and Registrant's
          Response Form that indicates how you will satisfy those requirements.

       NOTE: Item 6a and 6b are not applicable for Product Specific Data.

Item 7a   ON  THE PRODUCT SPECIFIC DATA FORM:  For each manufacturing use
          product (MUP) for which you wish to maintain registration, you must agree to satisfy
          the data requirements by responding "yes."

Item 7b.   For each end use product (EUP) for which you wish to maintain registration, you must
          agree to satisfy the data requirements by responding "yes."

       FOR BOTH MUP and EUP products

       You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product
       is identical to another product and you qualify for a data exemption.  You must provide the
       EPA registration numbers of your source(s); do not complete the Requirements Status and
       Registrant's Response form. Examples of such products include repackaged products and
       Special Local Needs (Section 24c) products which are identical to federally registered
       products.

       If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
       Status and Registrant's Response" form under Item 9, you must respond with  option 7
       (Waiver Request) for each study for which you are requesting a waiver.

       NOTE: Item 7a and 7b are not applicable for Generic Data.
                                         149

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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 8.     ON BOTH FORMS:  This certification statement must be signed by an authorized
            representative  of your company and the person signing must include his/her title.
            Additional pages used in  your response must be  initialled  and dated in the space
            provided for the certification.

Item 9.     ON BOTH FORMS: Enter the date of signature.

Item 10.    ON BOTH FORMS: Enter the name of the person EPA should contact with questions
            regarding your response.

Item 11.    ON BOTH FORMS: Enter the phone number of your company  contact.
 Note:     You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may
         wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For
         these cases, please supply all relevant details so that EPA can ensure that its records are correct.
                                              150

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  Instructions For Completing The "Requirements Status and Registrant's Response
              Forms" For The Generic and Product Specific Data Call-In
INTRODUCTION

   These instructions apply to the Generic and Product Specific "Requirements Status and
Registrant's Response Forms" and are to be used by registrants to respond to generic and product
specific Data Call-in's as part of EPA's reregi strati on program under the Federal Insecticide,
Fungicide, and Rodenticide Act.  If you are an end-use product registrant only and have been
sent this DCI letter as part of a RED document you have been sent just the product specific
"Requirements Status and Registrant's Response Forms." Only registrants responsible for generic
data have been sent the generic data response forms. The type of Data Call-In (generic  or
product specific) is indicated in item number 3 ("Date and Type of DCI") on each form.

   Although the form is the same for both product  specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for satisfying product specific data
requirements do not include (1) deletion of uses or (2) request for  a low volume/minor use
waiver.  Please read these instructions carefully before filling out the forms.

   EPA has developed these forms individually for each registrant,  and has preprinted these
forms to include certain information unique to this chemical. DO NOT use these forms for any
other active ingredient.

   Items 1 through 8 have been preprinted on the  form.  Item 9 must be  completed by the
registrant as appropriate.  Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.

   The  public reporting burden for this collection of information is estimated to average  30
minutes  per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the  data needed, and completing and reviewing the collection  of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch,  Mail Code 2136, 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.
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   INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                      REGISTRANT'S RESPONSE FORMS"

Generic and Product Specific Data Call-In
Item 1.    ON BOTH FORMS: This item identifies your company name, number and address.

Item 2.    ON THE GENERIC DATA FORM:  This item identifies the case number, case
          name, EPA chemical number and chemical name.

          ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the case
          number, case name, and the EPA Registration Number of the product for which the
          Agency is requesting product specific data.

Item 3.    ON THE GENERIC DATA FORM: This item identifies the type of Data Call-In.
          The date of issuance is date stamped.

          ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type of
          Data Call-In.  The date of issuance is also  date stamped.  Note the unique identifier
          number (ID#) assigned by  the Agency.   This  ID number must be used  in the
          transmittal document for any data submissions in response to this Data Call-In Notice.

Item 4.    ON BOTH FORMS: This item identifies the guideline reference number of studies
          required. These guidelines, in addition to the requirements specified in the Data Call-
          in Notice, govern the conduct of the required studies. Note that series 61 and 62 in
          product chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart
          c.

Item 5.    ON BOTH FORMS: This item identifies the study title associated with the guideline
          reference number and whether protocols  and  1, 2, or 3-year progress reports are
          required to be submitted in connection with the study. As noted in Section III of the
          Data Call-In Notice, 90-day progress reports are required for all studies.

      If an asterisk appears in Item 5, EPA has attached information relevant to this guideline
      reference number to the Requirements Status and Registrant's Response Form.
                                        152

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   INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                      REGISTRANT'S RESPONSE FORMS"

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           End-Use Product
      MP             Manufacturing-Use Product
      MP/TGAI       Manufacturing-Use Product and Technical Grade Active Ingredient
      PAI            Pure Active  Ingredient
      PAI/M         Pure Active  Ingredient and Metabolites
      PAI/PAIRA     Pure Active  Indredient or Pute Active Ingredient Radiolabelled
      PAIRA         Pure Active  Ingredient Radiolabelled
      PAIRA/M       Pure Active  Ingredient Radiolabelled and Metabolites
      PAIRA/PM     Pure Active  Ingredient Radiolabelled and Plant Metabolites
      TEP            Typical End-Use Product
      TEP	%      Typical End-Use Product, Percent  Active Ingredient Specified
      TEP/MET       Typical End-Use Product and Metabolites
      TEP/PAI/M     Typical End-Use Product or Pure Active Ingredient and Metabolites
      TGAI           Technical Grade Active Ingredient
      TGAI/PAI      Technical Grade Active Ingredient or Pure Active Ingredient
                                        153

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       TGAI/PAIRA    Technical  Grade  Active  Ingredient  or  Pure Active  Ingredient
                       Radiolabelled
       TGAI/TEP       Technical Grade Active Ingredient or Typical End-Use Product
       MET            Metabolites
       IMP             Impurities
       DEGR          Degradates
       *         See: guideline comment

Item 8.    This item completed by the Agency identifies the time frame allowed for submission
          of the study or protocol identified in item 5.

          ON  THE GENERIC DATA FORM:  The time frame runs from the date of your
          receipt of the Data Call-In notice.

          ON THE PRODUCT SPECIFIC DATA FORM: The due date for submission of
          product specific studies begins from the date stamped on  the letter transmitting the
          Reregi strati on Eligibility Decision document,  and not from the date  of receipt.
          However, your response  to the Data Call-In itself is due  90 days from the date of
          receipt.

Item 9.    ON BOTH FORMS: Enter the appropriate Response Code or Codes to show how
          you  intend to comply with each data requirement. Brief descriptions of each code
          follow. The Data Call-In Notice contains a fuller description of each of these options.

   Option 1.  ON BOTH FORMS:  (Developing Data) I will conduct a new study and submit
             it within the time frames specified in item  8  above. By indicating that I have
             chosen this option, I certify that I will comply with all  the requirements pertaining
             to the conditions for submittal of this study as outlined in the Data Call-In Notice
             and that I will provide the protocols  and progress reports  required in item 5 above.

   Option 2.  ON  BOTH FORMS:  (Agreement to  Cost Share) I  have  entered  into an
             agreement with one or more registrants to develop data jointly. By indicating that
             I  have chosen this option,  I certify that I will comply  with all the requirements
             pertaining to sharing in the cost of developing data as  outlined in the Data Call-In
             Notice.

             However, for Product Specific Data, I understand that this option is available for
          acute toxicity or certain efficacy data ONLY  if the Agency indicates in an attachment
          to this notice that my product is similar enough to another product to qualify for this
          option.  I certify that another party in the agreement is  committing to submit or
          provide the required data;  if the required study is not submitted on time, my product
          may be subject to suspension.

   Option 3.  ON BOTH FORMS:  (Offer to Cost Share) I have made an offer to enter into an
             agreement with one  or more registrants to develop  data jointly.  I am  also

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          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 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.

Option 5.  ON BOTH FORMS:  (Upgrading a Study) I will submit by the specified due
          date, or will cite data  to upgrade a study that EPA has classified as partially
          acceptable and potentially upgradeable.  By indicating that I have chosen this
          option, I certify that I have met all the requirements pertaining to the conditions
          for submitting or citing existing data to upgrade a study described in the Data
          Call-In Notice.  I am indicating on attached correspondence the Master Record
          Identification Number (MRID) that EPA has assigned to the  data that I am citing
          as  well as the MRID of the study I am attempting to upgrade.

Option 6.  ON BOTH FORMS: (Citing a Study) I am citing an existing study that has been
          previously classified by EPA as acceptable, core, core minimum,  or a study that
          has not yet been reviewed by  the  Agency. If  reviewed,  I am  providing  the
          Agency's classification of the study.

          However, for Product Specific Data,  I am citing another registrant's study.  I
       understand that this option is available ONLY for acute toxicity or certain efficacy
       data and ONLY if the cited study was conducted on my product,  an identical product
       or a product which the Agency has "grouped"  with  one or more other  products for
       purposes of depending on the same data. I may also choose this  option if I am citing
       my own data. In either case, I will provide the MRID or Accession number (s).  If I
       cite another registrant's data, I will submit a completed "Certification With Respect
       To Data Compensation Requirements" form.
                                      155

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   FOR THE GENERIC DATA FORM ONLY:  The following three options (Numbers 7,
   8, and 9) are responses that apply only to the "Requirements Status and Registrant's
   Response Form" for generic data.

   Option 7.  (Deleting Uses) I am attaching an application for amendment to my registration
             deleting the uses for which the data are required.

   Option 8.  (Low Volume/Minor Use Waiver Request) I have read the statements concerning
             low volume-minor use data waivers in the Data Call-In Notice and I request a
             low-volume minor use waiver of the data requirement. I am attaching a detailed
             justification to support this waiver request including, among other things, all
             information required to support the request. I understand that, unless modified by
             the Agency in writing, the data requirement as stated in the Notice governs.

   Option 9.  (Request for Waiver of Data) I have read the statements concerning data waivers
             other than lowvolume minor-use data waivers in the Data Call-In Notice and I
             request a waiver of the data requirement. I am attaching a rationale explaining why
             I believe the data requirements do not apply.  I am also submitting a copy of my
             current labels. (You must also submit a copy of your Confidential Statement of
             Formula if not already on file with EPA). I understand that, unless modified by the
             Agency in writing, the data requirement as stated in the Notice governs.

   FOR PRODUCT SPECIFIC DATA:  The following option (number 7) is a response that
   applies to the "Requirements Status and Registrant's Response Form" for product
   specific data.

   Option 7.  (Waiver Request)  I request a waiver for this study because it is 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 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 Call-In notice will not change.

Item 10.   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.

Item 11.   ON BOTH FORMS: Enter the date of signature.

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Item 12.    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:   You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you
            may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
                                                   157

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EPA'S BATCHING OF COUMAPHOS PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION

   In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing coumaphos as the active
ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable  concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.).  Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may  not be
considered chemically similar or have identical use patterns.

   Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.

   Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch.
It is the registrants' option to participate in the process with all other registrants, only some of the
other registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products.  If a registrant chooses to generate the data
for a batch, he/she  must use one of the products within the batch as the test material.  If a
registrant chooses to rely upon  previously submitted acute toxicity  data, he/she may do  so
provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested  is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and  acceptance of the acute
toxicity  data. Regardless of whether new data  is generated or existing data  is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product,  the registrant must indicate  the
formulation actually tested by identifying the corresponding CSF.

   In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and  submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product.  The second form, "Requirements Status and
Registrant's Response," lists the product specific  data required for each product,  including the
standard six acute toxicity tests.  A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of  products,  he/she must select one of the following options:
Developing Data (Option 1),  Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's data,
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he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing
an Existing Study (Option 6). If a registrant does not want to participate in a batch, the choices
are Options 1, 4, 5 or 6. However, a 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.

   Twenty-five products were found which contain coumaphos as the active ingredient. The
products have been placed into three batches and a "no batch" category in accordance with the
active and inert ingredients, type of formulation and current labeling. Table 1 identifies the
products in each batch.  Table  2 lists the products which have been placed in the "no batch"
category.
 Table 1
Batch
1
2
3
EPA Reg. No.
407-386
606-105
960-169
960-184
2393-378
2393-385
11556-4
11556-14
28293-122
34704-267
34704-306
47000-47
67517-21
67517-22
11556-20
11556-21
11556-23
34704-635
% coumaphos
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
25.0
25.0
11.6
11.6
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Liquid
Liquid
                                          159

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   The following table lists products that were either considered not to be similar or the Agency
lacked sufficient information for decision making and were not placed in any batch. Registrants
of these products are responsible for meeting the acute toxicity data requirements separately for
each product.

 Table 2 (No Batch)
EPA Reg. No.
11556-11
11556-25
11556-40
11556-98
11556-115
28293-88
28293-91
% Active Ingredient
90.0
4.0
3.0
42.0
5.8
3.0
5.0
Formulation Type
Solid
Liquid
Spray
Liquid
Liquid
Spray
Solid
                                           160

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LIST OF REGISTRANTS SENT THIS DATA CALL-IN (REMOVE THIS PAGE)
                                     161

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Instructions for Completing the Confidential Statement of Formula

The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required.  Following are basic instructions:

   a.  All the blocks on the form must be filled in and answered completely.

   b.  If any block is not applicable, mark it N/A.

   c.  The CSF must be signed, dated and the telephone number of the responsible party must
      be provided.

   d.  All applicable information which is on the product specific data submission must also be
      reported on the CSF.

   e.  All weights reported under item 7 must be in pounds per gallon for liquids and pounds per
      cubic feet for solids.

   f  Flashpoint  must be in degrees Fahrenheit and flame extension in inches.

   g.  For all active ingredients, the EPA Registration Numbers for the currently  registered
      source products must be  reported under column  12.

   h.  The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common
      names for the trade names must be reported.

   i.  For the active ingredients, the percent purity of the source products must be reported
      under column 10 and must be exactly the same as on the source product's label.

   j.  All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no
      case will volumes be accepted. Do not mix English and metric system units (i.e., pounds
      and kilograms).

   k.  All the items under column 13.b. must total  100  percent.

   1.  All items under columns 14.a. and 14.b. for the  active ingredients must represent pure
      active form.

   m.     The upper and lower certified limits for ail active and inert ingredients must follow
          the 40 CFR 158.175  instructions. An explanation must be provided if the proposed
          limits are different than standard certified limits.

   n.  When new CSFs are submitted and approved, all previously  submitted CSFs become
      obsolete for that specific formulation.
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Confidential Business Information: Does Not Contain National Securit
United States Environmental Protection Agency
_ Office of Pesticide Programs (TS-767)
^ C DA Washington, DC 2046O
X/tZ r/A Confidential Statement of Formula
1. Name
3. Product
EPA USE


and Address of Applicant/Registrant (Include ZIP Code)
Name
ONLY








10. Components in Formulation (List as actually introduced
into the formulation. Give commonly accepted chemical
name, trade name, and CAS number.!








f Information (E.O. 12065)
\ — I Basic Formulation
I — I Alternate Formulation
Form Approved. OMB No. 2070-0060. Approval Expires 2/28/94
B.
Page
of
See Instructions on Back
2. Name and Address of Producer (Include ZIP Code)
4. Registration No. /File Symbol
7. Pounds/Gal or Bulk Density
1 1. Supplier Name & Address








5 EPA Product Mgr/Team No
8. pH
12. EPA Reg. No.








1 6. Typed Name of Approving Official
1 8. Signature of Approving Official
13. Each Component
in Formulation
a. Amount b% by Weigh








17. Total Weight
19. Title








100%
6. Country Where Formulated
9. Flash Point/Flame Extension
14. Certified Limits
% by Weight
a Upper Limit b Lower Limit
















15 Purpose m
Formulation









20. Phone No. {Include Area Code!
21 Date
EPA Form  8570-4 (Rev.  12-90)     Previous editions are obsolete.   If you can photocopy this, please submit an additional copy. White-   EPA File Copy  (original)
Yellow -  Applicant copy

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Page Intentionally Blank
          164

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    r/EPA
United States  Environmental  Protection  Agency
            Washington,  DC  20460
   CERTIFICATION OF  OFFER  TO  COST
SHARE  IN THE  DEVELOPMENT OF  DATA
Form Approved

OMB No.  2070-0106
         2070-0057
Approval  Expires 3 31 96
 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

 Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
 I Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
 enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
 data.

 My firm has offered in writing to enter into such an  agreement.  That offer was irrevocable and included an
 offer  to be bound  by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
 terms could not be reached otherwise.  This offer was made to  the following  firm(s) on the following
 date(s):
  Name of Firm(s)
                                                                            Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
 EPA Form 8570-32 (5/91)    Replaces EPA Form 8580, which is obsolete
                                                 165

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                         United States Environmental Protection Agency
                                     Washington, DC 20460
                               CERTIFICATION WITH RESPECT TO
                            DATA COMPENSATION REQUIREMENTS
                                                                                ,^
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
  Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
  reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
  collection of information.  Send comments regarding the burden estimate or any other aspect of this collection of information,
  including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
  Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
  (2070-0106), Washington, DC 20503.

  Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
  I Certify that:

  1.    For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
  (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
  data submitter to cite that study.

  2.    That for each study cited in support of registration or reregistration under  FIFRA that is NOT an exclusive use study, I am the
  original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
  company(ies) that submitted data I  have cited and have offered to: (a) Pay compensation for those data in accordance with sections
  3(c)(1 )(F) and 3(c)(2)(D) of FIFRA;  and (b) Commence negotiation to determine which data are subject to the compensation
  requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)

   [  ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
  "Requirements Status and Registrants' Response Form,"

  3.    That I  have previously complied with  section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
  reregistration under FIFRA.
Signature
Date
  Name and Title (Please Type or Print)
  GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
  reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
  Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
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                 APPENDIX E - LIST OF RELATED DOCUMENTS


    The following is a list of available documents for coumaphos that my further assist you in
responding to this Reregi strati on Eligibility Decision document.   These  documents may be
obtained by the following methods:

Electronic
File format:   Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
             reader.  Electronic copies can be downloaded from the Pesticide Special Review
             and Reregi strati on Information System at 703-308-7224. They also are available
             on the Internet on  EPA's gopher server, GOPHER.EPA.GOV, or using ftp on
             FTP.EPA.GOV, or using WWW (World Wide Web) on WWW.EPA.GOV., or
             contact Edward Setren at (703)-308-8166.

    1.        PR Notice 86-5.

    2.        PR Notice 91-2 (pertains to the Label Ingredient Statement).

    3.        A full copy of this RED document.

    4.        A copy of the fact sheet for coumaphos.


    The following documents are part of the  Administrative Record for coumaphos and may
included in the EPA's Office of Pesticide Programs Public Docket.  Copies of these documents
are not available electronically, but may be obtained by contacting the person  listed on the
Chemical Status Sheet.

    1.        Health and Environmental Effects Science Chapters.

    2.        Detailed Label Usage Information System (LUIS) Report.

    The following Agency reference  documents are not available  electronically, but may be
obtained by contacting the person listed  on the Chemical Status Sheet of this RED document.

    1.        The Label Review  Manual.

    2.        EPA Acceptance Criteria
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