United States
Environmental Protection
Agency	
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA738-R-97-011
January 1998
Reregistration
Eligibility Decision (RED)

TERBACIL

-------

-------
                 United States
                 Environmental Protection
                 Agency
                        Prevention, Pesticides
                        And Toxic Substances
                        (7508W)
EPA-738-R-97-O11
January 1998
                 R.E.D.   FACTS
                 Terbacil
     Pesticide       All pesticides sold or distributed in the United States must be regis-
Reregistration  tered 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. To implement provi-
                sions of the Food Quality Protection Act of 1996, EPA considers the special
                sensitivity of infants and children to pesticides, as well as aggregate expo-
                sure  of the public to pesticide residues from all sources, and the cumulative
                effects of pesticides and other compounds with common mechanisms of
                toxicity. The Agency develops any mitigation measures or regulatory
                controls needed to effectively reduce each pesticide's risks.  EPA then
                reregisters pesticides that meet the safely standard of the FQPA and can be
                used without posing unreasonable risks to human health or the environ-
                ment.
                     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 0039, Terbacil.
   Use Profile
     Terbacil is a selective herbicide used to control broadleaf weeds on
terrestrial food/feed crops (e.g., apples, mint/peppermint/spearmint,
sugarcane, and.ornamentals), forestry [e.g., cottonwood
(forest/shelterbelt)], terrestrial food (e.g., asparagus, blackberry, boysen-
berry, dewberry, loganberry, peach, raspberry, youngberry and straw-
berry), and terrestrial feed (e.g.,.alfalfa, sainfoin (hay and fodder), and
forage).
     Formulations include a wettable powder and products are applied by
aircraft or ground equipment including boom sprayers.
     Use practice limitations include prohibition of applications through
any type of irrigation system.  They also prohibit grazing treated crops or
allowing hay, seeds or seed screening from treated crops to be used for food

-------
                    or feed.  Grazing or feeding forage or hay from treated areas to livestock is
                    prohibited.
    Regulatory
         History
Human Health
  Assessment
      Terbacil was first registered for use as a herbicide  in the U.S. in
 1966.  EPA issued a Registration Standard for terbacil in May 1982. In
 August 1989 a Registration Standard (Second Round Review) was issue for
 terbacil. This document reviewed data submitted in response to the 1982
 Registration Standard, updated the Agency's assessment of the terbacil data
 base, and included a tolerance reassessment. The Second Round Review
 required additional data in the area of toxicology, environmental fate,
 ecological effects, and residue chemistry. On August 3, 1996, the Food
 Quality Protection Act of 1996 (FQPA) was signed into law.  FQPA amends
 both the Federal Food, Drug, and Cosmetic Act (FFDCA), and the Federal
 Insecticide, Fungicide,  and Rodenticide Act (FIFRA).  The FQPA amend-
 ments went into effect immediately and were considered during this
 reregistration decision.  Currently, there are 5 active terbacil products
 registered.

 Toxicity
      In studies using laboratory animals, terbacil is slightly toxic by the
 oral and dermal routes and has been placed  in Toxicity Category IV (the
 lowest of four categories) for these effects.  For the inhalation route, the
 Toxicity Category is III.  Terbacil per se is  mildly irritating to the eyes
 (Toxicity Category III).
      In a chronic feeding study using beagle dogs, terbacil caused increased
 thyroid to body weight  ratios, slight increase hi liver weights, and elevated
 alkaline phosphatase levels.
      Terbacil.has been evaluated for potential carcinogenic activity hi mice
 and rats. Terbacil did not induce any increase hi tumor incidence in the
 treated animals.  Terbacil is classified hi Group E (no evidence of carcino-
genicity in animals studies) with respect to its cancer potential.
      Terbacil demonstrates some evidence of causing developmental
toxicity effects in rats and rabbits.  These effects are likely due to maternal
toxicity from exposure to bromacil rather than from specific developmental
toxicity of terbacil.  Therefore, the Agency  does not consider terbacil a
developmental toxicant.
 Dietary Exposure
     People may be exposed to residues of terbacil through the diet.
 Generally, acute dietary margins of exposure greater than 100 tend to cause
no dietary concern.  Because the endpoint of concern was a developmental
effect, the only sub-population of concern is females of child bearing age
 (i.e., females, 13+years old).  Presently registered commodities result hi an
MOE for females (13+ years) of 3125, which demonstrates that there is no

-------
 cause for concern regarding acute dietary exposure from terbacil for both
 existing and proposed uses.
      In assessing chronic dietary risk from food, EPA estimates that
 terbacil residues in food account for 12.2% of the RfD, based on existing
 tolerances and assuming 100% of the crop treated. 'Incorporating the results
 of the Agency's reregistration review (i.e., recommendationns to revoke
 tolerances for citrus fruits and pears, and to raise tolerances on caneberries,
 blueberries, peaches, apples, and sugarcane), 4.5% of the RfD is utilized.
      No  Codex Maximum Residue Limits (MRLs) have been established
 for terbacil for any agricultural commodity.  Therefore, no compatibility
 questions exist with respect to U.S. tolerances.                   '
 Occupational Exposure
      An  occupational exposure assessment is required for an active ingredi-
 ent if (I)'certain lexicological criteria are triggered and (2) there is potential
 exposure  to handlers (mixers, loaders, applicators, etc.) during use or to
 persons-entering treated sites after application is complete.  The Toxicity
 Endpoint  Selection Committee found that neither dermal nor inhalation
 toxicity criteria  were triggered for terbacil.  Therefore, no assessments are
 needed  for occupational exposure/risk at this time.
 Human Risk Assessment
      EPA conducted additional risk analyses using available data in re-
 sponse to  the new FQPA requirements. Based on current data require-
 ments, terbacil has a complete database for developmental and reproductive
 toxicity.  Because the developmental NOELs were the same as those for
 maternal toxiciry,  arid the NOEL for systemic (parental) toxiciry was higher
 than the NOEL for reproductive toxicity, these data do not suggest increased
 pre- or post-natal sensitivity of children and infants to terbacil exposure.
 Therefore, EPA concludes that the available toxicology data do not support
 an uncertainty factor of 1000 as specified in FQPA and that the present
 uncertainty factor of 100 is adequate to ensure the protection of infants and
 children from exposure to terbacil.  EPA estimates that terbacil residues in
 the diet of infants and children account for 12.8% of the RfD and residues
 in drinking water account for 81 % of the RfD. Therefore, the Agency
 concludes that aggregate risks for infants and children resulting from
terbacil uses are not of concern.
      In assessing aggregate risk dietary, exposure from food and drinking
 water were considered.  Aggregate acute dietary risk for females of child-
bearing  age was calculated and the MOE= 1563.  Acute dietary risk from
 food alone was calculated for females of child-bearing age and the
MOE=4166 (based on tolerance levels reassessed in this RED and 100%
crop treated).  In assessing aggregate chronic dietary risk, exposures from
food and drinking water were considered. The aggregate exposures account
for 27.6% of the RfD. Aggregate exposure/risk values are all below the

-------
                      level of Agency concern.  This includes the acute exposure of females of
                      child-bearing age.
                           In evaluating the potential for cumulative effects, EPA compared
                      terbacil with other structurally similar substituted uracil compounds, such as
                      bromacil and lentacil, and then with other compounds producing similar
                      effects.  A comparison of the available toxicological database for terbacil
                      and bromacil revealed no clear common mode of toxicity for the chemicals.
                      The toxicology database for lentacil was not considered because there are
                      currently no registered uses of lentacil.  Based on the available data, the
                      Agency has determined that there is no clear common mode of toxicity
                      between terbacil and bromacil.
  Environmental   Ecological Effects Risk Assessment
     Assessment        Minimal adverse acute effects are expected for avian, mammalian, and
                      aquatic species from labeled uses of terbacil.  Chronic effects for avian and
                      aquatic species cannot be evaluated at this time because of insufficient data.
                      However, chronic risk quotients (RQs) for mammals indicate that adverse
                      effects are possible from labeled uses of terbacil. There is some uncer-
                      tainty in assessing adverse chronic mammalian effects because the NOEL is
                      greater than the maximum concentration tested in rat reproduction study
                      design.  Therefore, the highest concentration is a default toxicity endpoint
                      which is a conservative estimate of risk.   Since terbacil is a persistent and
                      mobile herbicide,  non-target terrestrial plants are expected to be adversely
                      affected from runoff and spray drift.  Minimal adverse effects, however,
                      are expected for non-target aquatic plants. Because terbacil is used exclu-
                      sively on minor crops, terbacil exposure is expected to be very localized and
                      dependent on site specific conditions.  The localized nature of terbacil use
                      areas is expected to limit human and ecological exposure.

Risk Mitigation        To lessen the risks posed by terbacil, EPA is requiring the following
                      risk mitigation measures.
                      °    Maximum label application rates should be  reduced to be
                           representative of typical application rates.
                      o    The Agency recommends a surface water label advisory on terbacil
                           because it has characteristics (persistent and very mobile) of pesticides
                           found in surface waters. Surface water modeling for a
                           Louisiana sugarcane scenario indicates terbacil may accumulate at
                           concentrations greater than 1 mg/L.  Since terbacil is used on
                           vulnerable soils for surface water contamination such as the Louisiana
                           production area, a surface water label advisory is recommended.  The
                           label advisory should state: "Terbacil has properties that may result in
                           surface water contamination via dissolved runoff and runoff erosion.
                           Practices should be followed to minimize the potential for dissolved
                           runoff and runoff and/or runoff erosion."

-------
Additional Data
        Required
                        °    Terbacil is more mobile and persistent than a number of herbicides
                             which have been found to contaminate ground water. EPA has
                             recommended a ground water label advisory since 1989, and continues
                             to recommend this.  The following label language is appropriate:
                        "This chemical has properties and characteristics associated with chemicals
                        detected in ground water.  The use of this chemical in areas where soils are
                        permeable, particularly where the water table is shallow, may result in
                        ground water contamination. "                  •

                             EPA is requiring the following  additional generic studies for terbacil
                        to confirm its regulatory assessments  and conclusions:
                             •    Avian Reproduction Quail [71-4(a>]
                             •    Avian Reproduction Duck [71-4(b)]
                             •    Early Life-Stage Fish [72-4(a>]
                             •    Life-Cycle Aquatic Invertebrate [72-4(b>]
                             •    Aerobic Aquatic Metabolism [162-4]
                             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 terbacil end-use products must comply with EPA's current pesti-
Changes Required   cide product labeling requirements and with the following. For a compre-
                        hensive list of labeling requirements, please see the terbacil RED document,
                        PPE/Engineering  Control Requirements for Pesticide Handlers
                             For sole-active-ingredient end-use products that contain terbacil, the
                        product labeling must be revised to adopt the handler personal protective
                        equipment 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 terbacil,
                        the handler perspnal protective equipment requirements set forth in this
                        section must be compared to the requirements on the current labeling and
                        the more protective must be retained.  For guidance on which requirements
                        are considered more protective, see PR Notice 93-7.
                        Minimum PPE/Engineering Control Requirements
                             EPA is not establishing active ingredient-specific PPE or engineering
                        control requirements for terbacil end-use products.
                       Actual end-use product PPE requirements
                             Any necessary PPE for each terbacil occupational end-use product will
                       be established on the basis of the end-use product's acute toxicity category.
                       Placement in labeling
                             The personal  protective equipment 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.
Entry Restrictions
      For sole-active-ingredient end-use products that contain terbacil 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 terbacil
the entry restrictions  set forth in this section must be compared to the entry
restrictions on the current labeling and the more protective must be retained.
A specific time-period hi hours or days is considered more protective than
"sprays have dried" or "dusts have settled."
Restricted-entry interval
      A 12-hour restricted-entry interval (REI) is required for uses within
the scope of the WPS on all terbacil end-use products!
PPE/Engineering Control Requirements for Pesticide Handlers
      For sole-active-ingredient end-use products that contain terbacil, the
product labeling must be revised to adopt the handler personal protective
equipment 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 terbacil,
the handler personal protective equipment requirements set forth in this
section must be compared to the requirements on the current labeling and
the more protective must be retained. For guidance on which requirements
are considered more protective,  see PR Notice 93-7.
Minimum PPE/Engineering Control Requirements
      EPA is not establishing active ingredient-specific PPE or engineering
control requirements  for terbacil end-use products.
Actual end-use product PPE requirements
      Any necessary PPE for each terbacil occupational end-use product will
be established on the  basis of the end-use product's acute toxicity category.
Placement in labeling
      The personal protective equipment 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.
Entry Restrictions
      For sole-active-ingredient end-use products that contain terbacil 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.

-------
 Regulatory
 Conclusion
   For More
information
      For multiple-active-ingredient end-use products that contain terbacil
 the entry restrictions set forth in this section must be compared to the entry
 restrictions on the current labeling and the more protective must be retained.
 A specific time-period in hours or days is considered more protective than
 "sprays have dried" or "dusts have settled."
 Restricted-entry interval
      A 12-hour restricted-entry interval  (REI) is required for uses within
 the scope of the WPS on all terbacil end-use products.

      The use of currently registered products containing terbacil in accor-
 dance with approved labeling will not pose unreasonable risks or adverse
 effects to humans or the environment.  Therefore, all uses of these  products
 are eligible for reregistration.
      Terbacil products will be reregistered once the required product-
 specific data, revised Confidential Statements  of Formula, and  revised
 labeling are received and accepted by EPA.

      EPA is requesting public comments on the Reregistration Eligibility
 Decision (RED) document for terbacil 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 Information and Records Integrity
 Branch, Information Resources and Services (7502C), Office of Pesticide
 Programs (OPP),  US EPA, Washington, DC 20460, telephone
 703-305-5805.
      Electronic copies of the RED and this fact sheet are available  on the
 Internet.  See http://www.epa.gov/REDs.
      Printed copies of the RED and fact sheet can be obtained from EPA's
 National Center for Environmental Publications and Information
 (EPA/NCEPI),  PO Box 42419, Cincinnati, OH  45242-2419, telephone 1-
 800-490-9198;  fax 513-489-8695.
      Following the  comment period, the  terbacil 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 terbacil RED, or reregistration of individual products containing
terbacil, 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, from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to
7:30 pm Eastern Standard Time, seven days a  week.

-------

-------
                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                     WASHINGTON, D.C. 20460
                                                                           OFFICE OF
                                                                     PREVENTION, PESTICIDES
                                                                     AND TOXIC SUBSTANCES
CERTIFIED MAIL
                                                     SEP  3 0 1997
Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case terbacil, which
includes the active ingredient (3-tert-butyl-5-ehloro-6-methyl uracil). The enclosed
Reregistration Eligibility Decision (RED) contains the Agency's evaluation of the data base of
this chemical, its conclusions of the potential human health and environmental risks of the
current product uses, and its decisions and conditions under which these uses and products will
be eligible for reregistration. The RED includes the data and labeling requirements for
products for reregistration.  It also includes requirements for additional data (generic) on the
active ingredients to confirm the risk assessments.                                .

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

       Please note that the Food Quality Protection Act of 1996 ("FQPA") became effective
on August 3, 1996, amending portions of both the pesticide law (FIFRA) and the food and
drug law (FFDCA).  This RED takes into account, to the extent currently possible,  the new
safety standard set by FQPA for establishing and reassessing tolerances.  However,  it should
also be noted that in continuing to make reregistration determinations during the early stages
of FQPA implementation, EPA recognizes that it will .be necessary to make decisions, relating
to FQPA before the implementation process is complete.  In making these early case-by-case
decisions,  EPA does not intend to set broad precedents for the application of FQPA. Rather,
these early determinations will be made on a case-by-case basis and will not bind EPA as it
proceeds with further policy development and any rule-making that may be required.

-------
       If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue
whatever action may be appropriate, including but not limited to reconsideration of any
portion of this RED.

       If you have questions on the product specific data requirements or wish to, meet with
the Agency, please contact the Special Review and Reregistration Division representative
Karen Jones (703) 308-8047.  Address any questions on required generic data to the Special
Review and Reregistration Division representative Emily Mitchell (703) 308-8583.
                                                      Sincerely yours,
Enclosures
                                                     1 Lois A. Rossi, Director
                                                      Special Review and
                                                       Reregistration Division

-------
              SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
              THE REREGISTRATION ELIGIBILITY DECISION (RED)
 1  DATA CALL-IN rDCD OR "90-DAY RESPONSE"-If generic data ar
 reregistration, a DCI letter will be enclosed describing such data.  If product specific data
 are required, a DCI letter will be enclosed listing such requirements.  If both generic and
 product specific data are required, a combined Generic and Product Specific DCI letter will
 be enclosed describing such data. However, if you are an end-use product registrant only and
 have been granted a generic data exemption (GDE) by EPA, you are being sent only the
 product specific response forms (2 forms) with the RED. Registrants responsible for generic
 data are being sent response forms for both generic and product specific data requirements (4
 forms). You must submit the appropriate response forms (following the instructions
 provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
 may be suspended.

 2. TIME EXTENSIONS AND  DATA WAIVER REOUESTS-Nn time extension requests
 will be granted for the 90-day response.  Time extension requests may be submitted only with
 respect to actual data submissions. Requests for time extensions for product specific data
 should be submitted in the 90-day response.  Requests for data waivers must be submitted as
 part of the 90-day response. All  data waiver and time extension requests must be accompanied
 by a full justification. All waivers and time extensions must be granted by EPA in order to go
 into  effect.

 3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-Yn« must
 submit the following items for each product within eight months of the date of this letter
 (RED issuance date).

      a. Application for Reregistratinn (EPA Form 8570-1). Use only an original
 application form. Mark it "Application for Reregistration. " Send your Application  for
 Reregistration (along with the other forms listed in b-e below) to the address listed in item 5

      b- Five copies of draft labeling which complies with the RED and current regulations
 and requirements. Only make labeling changes which are required by the RED and  current
 regulations (40 CFR 156. 10) and policies. Submit any other amendments (such as formulation
 changes, or labeling changes not related to reregistration) separately.  You may, but are not
 required to, delete uses which the RED says are ineligible for reregistration.  For further
 labeling guidance, refer to the labeling section of the EPA publication "General Information
 on Applying for Registration in the U.S., Second Edition, August 1992" (available from  the
 National Technical Information Service, publication #PB92-221811; telephone number 703-
 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).

-------

-------
REREGISTRATION ELIGIBILITY DECISION

                TERBACIL

                  LIST A

                CASE0039
           ENVIRONMENTAL PROTECTION AGENCY
            OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

-------

-------
                        TABLE OF CONTENTS

TERBACIL REREGKTRATION ELIGIBILITY DECISION TEAM	    ....  i

I.     INTRODUCTION .   .........	 .....,;..,....	           1

H.    CASE OVERVIEW		  2
      A.    Chemical Overview . .  . . .	  ...........  2
           1.    UseProffie	, . .  , .	  2
           2.    Estimated Usage of Pesticide	3
                      (1)   Data Requirements	 . ;  4
           3.    Regulatory History	  5

m.   SCIENCE ASSESSMENT	.5
      A.    Physical Chemistry Assessment .  .	."...'	  5
           1.    Description of Chemical ......	  5
                a.    Identification of the Active Ingredient	  5
                      (1)   Manufacturing-use Products	, .  5
                      .(2)   Regulatory Background	  6
                      (3)   Conclusions for Product Chemistry ............  6
      B,    Human Health Assessment .	;  .........  6
           1.    Hazard Assessment	  6
                a.    Acute Toxicity  .	 . 6
                b.    Subchronic Toxicity .	;	 . 7
                c.     Chronic toxicity		 7
                d.    Carcinogenicity	 .	9
                e.    Developmental Toxicity	9
                f.    Reproductive Toxicity		 . 10
                g.    Mutagenicity  ."	10
                h.   Metabolism .		\\
          2.    Toxicological Endpoint of Concern Used in Risk Assessment ... 11
                a.    Reference Dose	   	; 11
                b.    Carcinogenicity Classification	 11
                c.,   Other Toxicological Endpoints	 .:•. .... 11
                     (1)   Acute Dietary	..;................ 12
                     (2)   Dermal Absorption ......... ... . .	12
                     (3)   Short and Intermediate Term Occupational	13
                     (4)   Chronic Occupational (Non-Cancer)	13
          3.    Exposure Assessment	13
                a.    Dietary Exposure (Food Sources)	 13
                     (1)   Directions for Use . . . ..................' 14
                     (2)   Nature of the Residue in Plants .	 15
                     (3)   Nature of the Residue in Livestock	 15
                     (4)   Residue Analytical Methods	15
                     (5)   Multi-residue Method Testing	; ... 16

-------
                   (6)    Storage Stability Data	17
                   (7)    Magnitude of the Residue in Crop Plants	17
                   (8)    Magnitude of the Residue in Processed Food/Feed
                          	17
                   (9)    Magnitude of the Residue in Meat, Milk, Poultry, and
                         Eggs	18
                   (10)   Magnitude of the Residue in Water, Fish, and
                         Irrigated Crops	18
                   (11)   Magnitude of the Residue in Food-Handling
                         Establishments	. . 18
                   (12)   Confined Accumulation in Rotational Crops	18
                   (13)   Field Accumulation in Rotational Crops  	18
             b.     Dietary Exposure (Drinking Water Sources)	 19
                   (1)    Groundwater		19
                   (2)    Surface Water	, . 20
      4.     Dietary Risk Assessment	23
             a.     Toxicologic Endpoints	 23
             b.     Residue Information	23
             c.     Chronic Exposure/Risk (1MRC)  	23
             d.     Acute Exposure/Dietary Risk	24
             e.     Drinking Water Risk (Ground Water)	 25
                   (1)    Acute Risk	25
                   (2)    Chronic Risk	25
             f.     Drinking Water Risk (Surface Water - Acute)  	25
             g.     Drinking Water Risk (Surface Water - Chronic)	26
      5.     Occupational Exposure and Risk Assessment	26
             a.     Summary of Use Patterns and Formulations   	27
             b.     Occupational-use products and homeowner-use products
                    . •	 .  .	27
             c.     Additional Occupational Exposure Studies . .	27
      6.     Food Quality Protection Act Considerations	27
             a.     Potential Risks to  Infants and Children	27
                   (1)    Developmental and Reproductive Effects	28
                   (2)    Uncertainty Factor  	28
                   (3)    Aggregate Exposure/Risk  	28
                   (4)    Total dietary (food source and drinking water) ...  29
             b.     Cumulative Effects	  30
C.    Environmental Assessment	 '. .	31
      1.    Ecological Toxicity Data	 .  31
             a.     Toxicity to Terrestrial Animals 	31
                   (1)    Birds, Acute and Subacute  	31
                   (2)   Birds, Chronic	  32
                   (3)   Mammals  .	32
                   (4)   Insects	32
            b.     Toxicity to Aquatic Animals	33

-------
IV.
                  (1)   Freshwater Fish, Acute . .	 33
                  (2)   Freshwater Fish, Chronic	'........... 34
                  (3)   Freshwater Invertebrates, Acute .	. .  . . 34
               .   (4)   Freshwater Invertebrates, Chronic	 34
                  (5)   Estuarine and Marine Fish, Acute	 34
                  (6)   Estuarine and Marine Fish, Chronic	35
                  (7)   Estuarine and Marine Invertebrates, Acute  ..... 35
                  (8)   Estuarine and Marine Invertebrate, Chronic  .... 36
            c.     Toxicity to Plants	'.	36
                  (1)   Terrestrial	.36
                  (2)   Aquatic	 38
      2.    Environmental Fate		39
            a.     Environmental Fate Assessment	 39
            b.     Environmental Fate and Transport	40
                  (1)   Degradation	     40
                  (2)   Mobility		 44
                  (3)   Accumulation	46
                  (4)   Field Dissipation	46
                  (5)   Spray Drift . .	 48
            c.     Water Resources  .	48
                  (1)   Ground Water	 49
                  (2)   Surface Water	 55
      3.    Exposure and Risk Characterization  . .	59
            a.     Ecological Exposure and Risk Characterization  	.61
                  (1)   Exposure and Risk to Nontarget Terrestrial Animals
                    	,		.	61
                  (2)   Exposure and Risk to Nontarget Aquatic Freshwater
                       Animals	 .......... 64
                  (3)   Exposure and Risk to Nontarget Plants  , . ...... 66
                  (4)   Endangered Species	70
            b.     Water Resources Risk Implication for Human Health ... 70
                  (1)   Ground Water	70
                  (2)   Surface Water	 .	 71
      4.    Environmental Risk Characterization	 71
      5.    Integrated Risk Characterization	 . .	72

RISK MANAGEMENT AND REREGISTRATION DECISION	77
A.    Determination of Eligibility  .'....	,  .	  .77
B.    Determination of Eligibility Decision	 . .	77
      1.    Eligibility Decision	'...'...'.'.'.':'.'.'.'.'.'.'. ] ] 77
      2.    Eligible and Ineligible Uses	  .78
C.    Regulatory Position	 78
      1.    Food Quality Protection Act Findings  	.;......	78
            a.    Determination of Safety for U.S. Population	 . 78
            b.    Determination of Safety for Infants and Children ...... 79

-------
             2.     Tolerance Reassessment . ,	 .  80
                   a.     Tolerances Listed Under 40 CFR §180.209(a)	80
                   b.     Tolerances Listed Under 40 CFR §180.209(b)	81
                   c.     Codex Harmonization	83
             3.     Tolerance Revocations and Import Tolerances	83
             4.     Ecological Effects	:	83
             5.     Endangered Species Statement  	84
             6.     Surface Water . . .	84
             7.     Ground Water	84
             8.     Occupational Labeling Rationale/Risk Mitigation	85
                   a.     The Worker Protection Standard (WPS)	85
                   b.     Personal Protective Equipment/Engineering Controls for
                         Handlers .	85
                         (1)    Occupational-Use Products  	85
                         (2)    Homeowner Use Products	  86
                   c.     Post-Application/Entry Restrictions .	86
                         (1)    Restricted Entry Interval	86
                         (2)    Early Entry PPE	87
                         (3)    WPS Double Notification Statement	88
                         (4)    Entry Restrictions for Occupational-Use Products
                               (Non-WPS Uses)	88
                   d.     Other Labeling Requirements	88
             9.     Spray Drift Advisory	88

V.    ACTIONS REQUIRED OF REGISTRANTS	88
      A-     Manufacturing-Use Products	89
             1.     Additional Generic Data Requirements	89
             2.     Labeling Requirements for Manufacturing-Use Products	   89
      B.     End-Use Products  .	91
             1.     Additional Product-Specific Data Requirements	  91
             2.     PPE/Engineering Control Requirements for Pesticide Handlers  .  91
                   a.    Minimum PPE/Engineering Control Requirements	91
                   b.    Actual end-use product PPE requirements	  91
                   c.    Placement in labeling .	92
             3.     Entry Restrictions	92
                   a.    Restricted-entry interval	92
                   b.    Early-entry personal protective equipment (PPE)	92
                   c.    Placement in labeling	92
             4.     Spray Drift Labeling	92
             5.     Other Labeling Requirements	  93
             6.     Existing Stocks	: .  96

VI.   APPENDICES	 .  99
      APPENDIX   A.    Table of Use Patterns Subject to Reregistration	 100

-------
APPENDIX  B.    Table of the Generic Data Requirements and Studies Used to
                  Make the Reregistration Decision	......... 112
APPENDIX  C.    Citations Considered to be Part of the Data Base Supporting
                  the Reregistration of TERBACEL ................ 117
APPENDIX  D.    Combined Generic and Product Specific Data Call-in . . 135
      Attachment  1.    Chemical Status Sheets	 155
      Attachment  2.    Combined Generic and Product Specific Data Call-in
                       Response Forms (Form A inserts) Plus Instructions
                        • . .	 ...  •		. .". . 157
      Attachment  3.    Generic and Product Specific Requirement Status and
                       Registrant's Response Forms (Form B inserts) and
                       Instructions	, . 161
      Attachment  4.    EPA Batching of End-Use Products for Meeting Data
                       Requirements for Reregistration	  169
      Attachment  5.    List of AH Registrants Sent This Data Call-in (insert)
                       Notice	  171
      Attachment  6.    Cost Share, Data Compensation Forms, Confidential
                       Statement of Formula Form and Instructions  . . .  172
APPENDIX  E.     List of Available Related Documents	  178

-------
                                     Tables

Table 1: Various U.S. Crops Treated Annually with Terbacil	4
Table 2: Acute Toxicity Data for Terbacil	• •  • •	 7
Table 3: Summary of Toxicological Endpoints for Terbacil	12
Table 4: Terbacil and its Metabolites	14
Table 5: Avian Acute Oral Toxicity	 31
Table 6: Avian Subacute Dietary Toxicity	 31
Table 7: Mammalian Toxicity	 32
Table 8: Nontarget Insect Acute Contact Toxicity	 33
Table 9: Freshwater Fish Acute Toxicity	33
Table 10: Freshwater Invertebrate Acute Toxicity  	: 34
Table 10: Estuarine/Marine Fish Acute Toxicity	35
Table 10: Estuarine/Marine Invertebrate Acute Toxicity	35
Table 11: Nontarget Terrestrial Plant Seedling Emergence Toxicity (Tier IT)	37
Table 12: Nontarget Terrestrial Plant Vegetative Vigor Toxicity (Tier n)	 38
Table 13: Nontarget Aquatic Plant Toxicity (Tier n)	39
Table 14: Leaching potential of terbacil compared with some major use herbicides  . . 49
Table 15: Leaching potential of terbacil compared with herbicides with similar use
      patterns	50
Table 15: Data Used for GENEEC and PRZM- EXAMS Modeling	56
Table 16: Estimated Environmental Concentrations (EECs) For Aquatic Exposure  . . 56
Table 17: Tier TL PRZM-EXAMS Modeling Input Parameters  	57
Table 18: Tier H Maximum PRZM-EXAMS Aquatic Estimated Environmental
      Concentrations for Terbacil. .	58
Table 19: Risk Presumptions for  Terrestrial Animals 	61
Table 20: Risk Presumptions for  Aquatic Animals	 61
Table 21: Risk Presumptions for  Non-Target Plants	61
Table 22: Estimated Environmental Concentrations on Avian and Mammalian Food
      Items	62
Table 23: Avian Acute Risk Quotients for Single Application of Nongranular Products
      (Broadcast) Based on  pheasant1 LC.^21,141 ppma.i	62
Table 24 : Mammalian (Herbivore/Insectivore) Acute Risk Quotients for Single
      Application of Nongranular Products (Broadcast) of Terbacil	63
Table 25: Mammalian Chronic Risk Quotients for Terbacil Based on a Rat NOEL >250
      ppm in a 3-generation rat  study	64
Table 26: Estimated  Environmental Concentrations (Ibs a.i./A) For Terrestrial and Semi-
      Aquatic Plants for a Single Application	67
Table 27: Acute High Risk Quotients from a Single Application for Terrestrial and  Semi-
      Aquatic Plants	 68
Table 28: Acute Risk Quotients for Aquatic Plants based upon a duckweed  	69
Table 29: Typical Terbacil Use Rates	76
Table 30: Tolerance Reassessment Summary for Terbacil	 82
Table 31: Typical Terbacil Use Rates	  . 90

-------
 TERBACIL REREGISTRATION ELIGIBILITY DECISION TEAM

 Office of Pesticide Programs:

 Biological and Economic Analysis Assessment
 Neil Anderson
 Jihad Alsadek
Herbicide/Insecticide Branch
Economic Analysis Branch
 Environmental Fate and Effects Risk Assessment
 James Hetrick
 David Wells
 Michael Davy
, Mah Shamim

 Health Effects Risk Assessment

 Jack Arthur
 Melba Morrow
 David Miller
 Brian Steinwand

 Registration Support Risk Assessment

 Wesley Allen
 Debbie  McCall
 Vickie Walters

 Risk Management

 Emily Mitchell
 Joseph Bailey
Environmental Risk Branch I
Environmental Risk Branch JJ
Environmental Risk Branch JJ
Environmental Risk Branch IV
Risk Characterization and Analysis Branch
Registration Action Branch 1
Chemistry and Exposure Branch 2
Chemistry and Exposure Branch 1
Fungicide-Herbicide Branch
Registration Support Branch
Fungicide-Herbicide Branch
Reregistration Branch I
Reregistration Branch I

-------
11

-------
             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
 DRES         Dietary Risk Evaluation System                                           .       /
 DWEL         Drinking Water Equivalent Level (DWEL)  The DWEL represents a medium specific (i.e.
               drinking water) lifetime exposure at which adverse, non carcinogenic health effects are not
               anticipated to occur.                                           "
 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
 FQPA         Food Quality Protection 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
 LCSO           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.
 LDSO           Median Lethal Dose.  A statistically derived single dose that can be expected to cause death in
               50% of the test animals when administered by the route indicated (oral,, dermal, inhalation). It is
               expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
 LDi0           Lethal Dose-low. Lowest Dose at which lethality occurs.
 LEL           Lowest Effect Level
 LQC           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.
;ig/g           Micrograms Per Gram
/wg/L           Micrograms per liter                                                     .         •
mg/L          Milligrams Per Liter
MOE          Margin of Exposure                                      .•-•'.
MP            Manufacturing-Use Product  .
MPI           Maximum Permissible Intake
                                               111

-------
             GLOSSARY OF TERMS AND ABBREVIATIONS

 MRID         Master Record Identification (number).  EPA's system of recording and tracking studies
               submitted.
 N/A           Not Applicable
 NOEC         No Observable Effect Concentration
 NPDES        National Pollutant Discharge Elimination System
 NOEL         No Observed Effect Level
 NOAEL       No Observed Adverse Effect Level
 OP            Organophosphate
 OPP           Office of Pesticide Programs
 Pa            pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
 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'i            The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
 RBC           Red Blood Cell
 RED           Reregistration Eligibility Decision
 REI           Restricted Entry Interval
 RfD           Reference Dose
 RS            Registration Standard
 RUP           Restricted Use Pesticide
 SLN           Special Local Need (Registrations Under Section 24® of FIFRA)
 TC            Toxic Concentration. The concentration  at which a substance produces a toxic effect.
 TD            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
WP            Wettable Powder
WPS           Worker Protection Standard
                                              IV

-------
 ABSTRACT

       This  Reregistration Eligibility Decision Document (RED) addresses the reregistration
 eligibility of the pesticide terbacil, which includes the active ingredient 3-tert-butyl-5-cbloro-6-
 methyluracil. Products containing terbacil are registered for use as herbicides.

       Terbacil was registered for use as a herbicide in the United States in 1966.  This decision
 includes a comprehensive reassessment of the required target data and the use patterns of currently
 registered products,  Terbacil is a selective herbicide, formulated as a wettable powder, and is
 applied  by  aircraft or  ground  equipment on  terrestrial  food/feed  crops  (e.g., apples,
 mint/peppermint/spearmint,  sugarcane,   and  ornamentals),  forestry  (e.g.,  cottonwood
 (forest/shelterbelt), terrestrial food (e.g.,  asparagus, blackberry,  boysenberry, dewberry,
 loganberry, peach, raspberry,  youngberry and strawberry), and terrestrial feed (e.g., alfalfa,
 sainfoin (hay and fodder), and forage). Products containing terbacil are not currently registered
 for residential use.

       The Agency has concluded that all uses, as prescribed in this document, will not cause
 unreasonable risks to humans  or  the environment and therefore, all products are eligible for
 reregistration.

       Short and intermediate term  toxicity endpoints sufficient to  be of occupational concern
 were not identified for terbacil.  The oral and dermal LDSO and dermal irritation studies  all
 resulted in Category IV toxicity classifications. Inhalation and eye irritation studies gave results
 to meet Category m requirements,  and no dermal sensitization was found.  Because of these
 findings, risk assessments were not necessary for occupational exposure scenarios,  and therefore,
 are not factored into aggregate risk calculations.

       Developmental toxicity was selected as the endpoint of  concern  for acute dietary risk
 (NOEL of 12.5 mg/kg/day, based  on the decrease in the number of live fetuses seen at the next
 highest dose  level in a rat study).  All dietary food and drinking water sources of terbacil were
 analyzed relative to this NOEL, for females of child-bearing age (i.e., 13+ years-old).  Based
 on these analyses, acute dietary exposure is not a concern for terbacil. Animal tests showed  no
 evidence of carcinogenicity for terbacil (i.e., classified as E).

       To assess the potential risks to infants and children under the new Food Quality Protection
Act  (FQPA), the Agency  evaluated  two  developmental studies and  one reproduction study.
Because the developmental NOELs were the same as those for maternal toxicity, and the NOEL
for systemic toxicity was higher than the NOEL for reproductive toxicity in these studies, the data •
do not suggest an increased pre- or post-natal sensitivity of children and  infants exposure  to
terbacil.  The standard 100-fold uncertainty factor is considered by the Agency to be sufficiently
protective of infants and children,  and an additional safety factor is not warranted.

-------
        The reference dose (RfD) for terbacil is 0.013  mg/kg/day, based on increased liver
 weights and serum alkaline phosphatase in dogs at the next highest dose level, and an uncertainty
 factor of 100.

        Chronic dietary risks from food sources (expressed as %RfD) were calculated by the
 DRES model which used tolerance values for food crops before and after adjustments had been
 made (e.g., recommendations are made to revoke tolerances for citrus fruits and pears, and raise
 tolerances on caneberries, blueberries, peaches, apples and sugarcane).  None of the scenarios
 for chronic dietary risk from food sources resulted in values that concern the Agency.

        Chronic dietary risks from drinking water were  analyzed for surface water using the
 results from a Tier Two model (PRZM), which gives values for each crop separately. Because
 of conservative model parameters, it  is expected to  over-estimate terbacil concentrations in
 drinking water.  None of the scenarios exceeded 100% of the  RfD.  None of the aggregate risk
 numbers exceeded the RfD.

       Terbacil is a persistent and potentially mobile herbicide in terrestrial environments. These
 environmental fate properties suggest terbacil can potentially move into both ground and surface
 waters. Tier n surface modeling  suggest terbacil may potentially accumulate in surface water at
 concentrations from 28 to 1470 pcg/L.  Further analysis  of Tier  n peak Estimated Environmental
 Concentration (EECs) indicate the first year EEC and annual incremental concentration (slope)
 were 105 and 36 ^g/L for Louisiana sugarcane; 24 and 4.3 /*g/L for New York apples; 34 and
 0.00 jig/L for Georgia peaches; and 5.2 and 0.52 /ig/L for Washington apples.  The peak ground
 water concentration, based on the Ground Water Interactive Concentration (GWIC) screening
 model, is not expected to exceed 125 jig/L. Since reliable ground and surface water monitoring
 data are not  available, estimated environmental concentrations of terbacil are based solely on
 ground and surface water models.

       All environmental fate data are fulfilled at this time.  However, additional information on
 the aerobic aquatic metabolism (Guideline 162-4) of terbacil is needed because terbacil is likely
 to move into surface waters.  These data will provide a more realistic assessment of terbacil
 concentrations in surface waters.

       All ecological  toxicity data  are fulfilled except for chronic  avian and aquatic toxicity
 studies (Guideline 71-4 Avian Reproduction Study; Guideline 72-4  Fish Early Life  Stage and
 Aquatic Invertebrate Life Cycle).  These data are needed because terbacil is a persistent compound
 which may pose long-term exposure in  terrestrial and aquatic environments.  Wild mammal
 toxicity study (Guideline 71-3)  is reserved  pending the  result of avian  reproduction studies
 (Guideline 71-4).

       Minimal adverse acute effects are expected for avian,  mammalian, and aquatic species
 from labeled terbacil uses.   Chronic effects for avian  and aquatic species cannot be evaluated
because of insufficient data.  However, chronic RQs for mammals indicate adverse effects are
possible from terbacil labeled uses. The rat reproductive study shows the NOEL to be higher than
                                           VI

-------
 the greatest concentration tested.  This concentration is below the maximum and mean predicted
 residue values (Kenaga/Fletcher) on mammalian food items.  Since the rat reproductive endpoint
 is greater than the highest concentration tested, EPA used that concentration level as  a default
 toxic reproductive endpoint.  This, assumption's more conservative and protective because toxic
 endpoints are expected to be higher than the default NOEL level.  Based on the Agency's
 assessment, no evidence of carcinogenicily was detected. The Agency's  mammal chronic feeding
, toxicity Studies indicate there may be increased liver and thyroid weights for rats.  Since terbacil
 is a persistent and mobile herbicide,  non-target terrestrial plants are  expected to be adversely
 effected from runoff and spray drift.   Minimal adverse effects,  however,. are expected for non-
 target aquatic plants. The fact that terbacil is used exclusively on minor crops, terbacil exposure
 is expected to be very localized and dependent on site specific conditions.  The localized nature
 of terbacil use is expected to limit human and ecological exposure.

       Before reregistering the products containing terbacil, the Agency is requiring that product
 specific data, revised Confidential Statements of Formula (CSF) and revised labeling be submitted
 within eight  months of the issuance of this document. These data include product chemistry for
 each registration and acute toxiciry testing.  After reviewing these data and any revised labels and
 finding them  acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister
 a product. Those products which contain other active ingredients will be eligible for reregistration
 only when the other active ingredients are determined to be eligible for reregistration.
                                           Vll

-------

-------
I.
INTRODUCTION
       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements..The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
                             '          I '   '
       FIFRA  Section  4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential  hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.

       On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170)  was signed into law.  FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 etseq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq.  The FQPA amendments went into effect immediately.  As a
result, EPA is embarking on an intensive process,  including consultation with registrants, States,
and other interested stakeholders, to make decisions on the new policies and procedures that will
be appropriate  as a result of enactment of FQPA.  This process will include a more in depth
analysis of the  new safety standard and how it should be applied to both food and non-food
pesticide applications.  The FQPA did not, however, amend any of the existing reregistration
deadlines hi section 4 of FIFRA. The Agency will therefore continue its ongoing reregistration
program while it continues to determine how best to implement FQPA.

       This document presents the Agency's decision regarding the reregistration eligibility  of
the registered uses of terbacil including the risk to infants and children for any potential dietary,
drinking water, dermal or oral exposures, and cumulative effects as stipulated under the  FQPA.
The document consists of six sections. Section I is the introduction. Section n describes terbacil,
its uses, data requirements and regulatory history. -Section HI discusses the human health and
environmental assessment based on the data available to the Agency.; Section IV presents the
reregistration decision for terbacil .  Section V discusses the reregistration requirements for
terbacil '.  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.

-------
H.    CASE OVERVIEW

       A.    Chemical Overview
t

             The following active ingredient(s) are covered by this Reregistration Eligibility
       Decision:

       •     Common Name:  Terbacil

       •     Chemical Name:  3-tert-butyl-5-chloro-6-methyluracil

       •     Other Chemical  Nomenclature:    5-chloro-3-(l,l-dimethylethyl)-6-methyl-
             2,4(lH,3H)-pyrimidinedione

       •     CAS Registry Number:  5902-51-2

       •     OPP Chemical Code:  012701

       •     Empirical Formula: C9H13C1N2O2

       •     Trade and Other Names:  Sinbar*,  DuPont Herbicide 732, and Geonter

       •     Basic Manufacturer: E.I. DuPont de Nemours Company, Inc.
    !
             1.    Use Profile

             The following is information on the currently registered uses with an overview of
      use sites and application methods.  A detailed table of the uses of terbacil is in Appendix
      **••                                        ^,

             For Terbacil:

            Type of Pesticide:  Herbicide

            Use Sites:   Terrestrial Food and Feed Crop:
                         apples, mint/peppermint/spearmint, sugarcane, and ornamentals

                         Forestry:
                         cottonwood (forest/shelterbelt)

                         Terrestrial Food:
                         asparagus, blackberry, boysenberry, dewberry, loganberry, peach,
                         raspberry, youngberry, and strawberry

-------
                    Terrestrial Feed:                          .
                    alfalfa and sainfoin (hay and fodder), and forage

       Target Pests: A broad spectrum of broadleaf weeds and grasses

       Formulation Types Registered:

              Wettable Powder 80% &
              Wettable Powder 40%

       Method and Rates of Application:

              Equipment -  Boom Sprayer & Aircraft
              Method and Rate -
Tractor-mounted  spray  boom application to soil
surface and small  emerged  weeds and  aerial
application-See  APPENDIX   A  for  detailed
breakdown
              Timing - Application times vary with crops.

       Use Practice Limitations:  Do not apply through any type of irrigation system.
                                 Do not graze  treated crop or allow hay, seeds or
                                 seed  screenings from treated, crop to be used for
                                 food or feed.  Do not graze or feed forage or hay
                                 from treated areas to livestock.

       2.     Estimated Usage of Pesticide

       This section summarizes the best estimates available for the pesticide uses of
terbaeil. These estimates are derived from a variety  of published and proprietary sources
available to the Agency. The data, reported on an aggregate and site (crop) basis, reflect
annual fluctuations in use patterns  as well as the variability in using data from various
information sources.  Table 1 below summarizes the pesticides use by site.
                                    3

-------
Table 1: Various U.S. Crops Treated Annually with Terbacil

: Site
0.00
Acres Treated
{000}
Likely
Average
Lifeely
Max
% of Crop
Treated
Likely
Average
Likely
Max
LB A,!, Applied
(DOty
Likely
Average
Likely
Max
Application
Rates
L8a.i/
acre/yr
#appl
/year
States of Most Usage
AG~SUBS
Alfalfa
Apples
Asparagus
Berries*
Mint
Peaches
Sugarcane
24,338
457
86
115
140
176
936
Ag Subtotal
50
40
1
25
100
60
125
401
70
50
3
45
110
100
175
533
0.00
9
1.
22
71
34
13

0.00
1.1
4
39
79
57
19

20
40
1
5
95
10
50
221
35
50
2
20 '
115
. 25
200
447
0.4
1.0
1.0
0.2
1.0
0.2
0.4

1
1
1
1
1
1
1

NE, OK, OR, WA
WA, NY, PA
MI
WI, OR, MI, ME
OR, WA, ID
GA, SC
LA

- , ,NQN~AG SITES
Fallow
Forest Trees
Ornamental
-
2,500
200
Non-Ag Subtotal
Grand total
2
1
1
4
405
5
2
2
9
562

0.00
1 '



0.00
1


7
1
1
9
230
10
2
2
14
461
3.5
1.0
1.0


-
-
-


-
-
-


Calculations of the above numbers may not appear to agree because they are displayed as rounded.
0 = < 500 acres treated or Ib. a.i. because of rounding to the nearest 1,000.
0% = < 0.5% because of rounding to the nearest whole percentage point.
NO OBS «« No Observations. This site is covered by EPA sources, but little or no usage is observed, or may be included with
all other pesticides.  For this sites a likely maximum percent treated is included, above which the actual usage is unlikely.
- = insufficient data to determine an amount for this field/
Usage data primarily covers 1990 - 1995 for most sites and as early as 1987 for some sites.
Likely averages are based on weighted averages of data with most recent years and more reliable data weighted more heavily.
Likely maximums are an amount above which the actual usage is unlikely to exceed.
Application rates are calculated from likely averages or are based on typical rather than maximum rates.
* Other/Crop Groups
Berries includes all berries.
SOURCES: EPA data, USDA, and National Center for Food and Agricultural Policy


                                (1)     Data Requirements


                Data requested  in the 1989 Registration Standard for terbacil include studies  on
        product chemistry, toxicological effects, ecological effects, and environmental fate. These
        data were required to support the uses listed in the Registration Standard.  Appendix B
        includes all data requirements identified by the Agency for currently  registered uses
        needed to support reregistration.

-------
       3,    Regulatory History

       Terbacil was registered for use as a herbicide in the United States in 1966.  A
Registration Standard was issued for terbacil in May 1982.  Additional data was required
in the areas of product chemistry, toxicology, environmental fate and ecological effects.
In August 1989 a Registration Standard (Second Round Review) was issued for terbacil.
This document reviewed data submitted in response to the 1982 Registration Standard,
updated the Agency's assessment of the terbacil data base, and included  a  tolerance
reassessment.   The Second Round Review required additional data in the area of
toxicology,  environmental  fate, ecological  effects,  and residue chemistry.    This
Registration Eligibility Document reflects an assessment of all data submitted in response
to the Second Round Review,

SCIENCE ASSESSMENT

A.     Physical Chemistry Assessment

       1.     Description of Chemical

             Terbacil [3-?erf-butyl-5-chloro-6-methyluracil] is a selective herbicide
       used for the control of many annual and some perennial weeds in crops.
                            ci
                          Empirical Formula:
                          Molecular Weight:
                          CAS Registry No.:
                          OPP Chemical Code:
                                 C9H13C1N202
                                 216.7
                                 5902-51-2
                                 012701
             a.
Identification of the Active Ingredient
             Terbacil is a white crystalline solid with a melting point of 175-177° C.
      Terbacil is soluble in water (710 ppm) at 25° C, and is moderately soluble in
      organic solvents including dimethylformamide (33.7 g/100 g), cyclohexanone (22
      g/100 g), and xylene (6.5 g/100 g).

                   (1)   Manufacturing-use Products

             According to a search of the Agency's Reference Files conducted 9/9/96,
      there are no terbacil manufacturing-use products (MUPs) registered under the OPP
      Chemical Code 012701; however, the E.I. du'Pont de Nemours and Company,
      Inc. 80% wettable powder (WP; EPA Reg. No. 352-317) is manufactured from

-------
       an unregistered TGAI (95%a.i.).  Only the du Pont TGAI is subject to this
       reregistration eligibility decision.

                    (2)     Regulatory Background

             The Terbacil Guidance Document dated 5/82 requked additional generic
       product chemistry data for terbacil; however, the Terbacil Reregistration Standard
       Second  Round Review (SRR)  dated 3/8/89, requked that all new product
       chemistry data be submitted, and reviewed data submitted in response the Guidance
       Document.  The Terbacil SRR required additional data concerning GLNs 61-2, 61-
       3, 62-1, 63-7, 63-9, 63-11, 63-12, and  63-13 (OPPTS  830.1620, 830.1670,
       830.1700, 830.7300, 830.7950, and 830.7550-7570, 830.7000, and 830.6313) for
       the du Pont TGAI.  No new data were submitted/reviewed under the Terbacil
       Reregistration Standard Update dated 10/8/91.

                    (3)     Conclusions for Product Chemistry

             All pertinent data requirements are satisfied for the du Pont TGAI except
       for a new  data requirement concerning UV/visible  absorption for the TGAI
       (OPPTS GLN 830.7050). The registrant should submit the data required for the
       terbacil TGAI, or either certify that the suppliers of beginning materials and the
       manufacturing process for the TGAI have not changed since the kst comprehensive
       product chemistry review or submit a complete updated product chemistry data
       package.

B.     Human Health Assessment

       1.    Hazard Assessment

             The  toxicology data base for  terbacil is adequate and will  support the
       reregistration eligibility of this chemical.

             a.     Acute Toxicity

                    Terbacil 80%  wettable powder (WP) has been tested in acute oral
             toxicity studies with rats (Ace. Nos. 114693 and 24955) and has an acute
             oral  LD50 of >  5,000 mg/kg/day  (Toxicity Category IV).  In an acute
             dermal toxicity study in rabbits,  the LD50 was  >  5,000 mg/kg/day
             (Toxicity Category IV), with no toxic signs noted (Ace. Nos.  114693 and
             24955). Technical terbacil (97.8%) was tested in an acute inhalation study
             in rats (MRID 00125700),  which indicated that the LC50 was > 4.4 mg/L
             (Toxicity Category TH).  Technical terbacil (96.1 %) was tested in rabbits'
             eyes  and produced only mild conjunctiva! effects, which cleared within 72
             hours (Toxicity Category ffl). Although a primary dermal irritation study

-------
                    is not available on technical terbacil, the Agency had indicated to the
                    Registrant that if no dermal irritation was observed in a 21-day subchronic
                    dermal study, then the requirements for the primary dermal irritation study
                    would be satisfied (Tox. Doc. 003401). No dermal irritation was reported
                    in that study (MRID 00125785).  Terbacil is not a dermal sensitizing agent
                    in guinea pigs (Ace. Nos.  157180). Table 2 below summarizes the values
                    and toxicity categories for the various acute toxicity routes.
Table 2: Acute Toxicity Data for Terbacil
Test - -
Oral LD50
Inhalation LCSO
Dermal LD30
Eye Irritation
Dermal Irritation
Dermal Sensitization
%AI
80.0
97.8
80.0
96.1
80.0
96.1
Result
> 5000 Tag/kg/day
> 4.4mg/L
> 5000 mg/kg/day r
Mild conjunctiva! irritant up to 7? hours
Not a skin irritant
Not a dermal sensitizer
i Category
IV
m
IV
m
IVs

a Based on a 21-day dermal toxicity study in rabbits.

                    b.     Subchronic Toxicity
                           Subchronic oral toxicity was tested in a 90-day feeding study in rats
                    £MRIDs 00039009 and 00068035). A NOEL of 100 ppm (equivalent to 5
                    mg/kg/day) and LOEL of 500 ppm, equivalent to 25 mg/kg/day (HDT)
                    were established, based on increased absolute and relative liver weights,
                    vacuolization and hypertrophy of hepatocytes. The data requirement for
                    subchronic oral toxicity in a nonrodent was satisfied by a 2-year feeding
                    study in beagle dogs (MRID 00060851), in which a NOEL  of 50 ppm
                    (equivalent to 1.25 mg/kg/day) and LOEL of 250 ppm (equivalent to 72
                    mg/kg/day) were established, based on increased thyroid to body weight
                    ratios, slight increase in liver weights, and elevated alkaline phosphatase
                    levels.      ,    "

                           Subchronic dermal toxicity was tested in a 21-day study in rabbits
                    (MRID 125785).  Terbacil (80% a.i.) was applied to prepared skin of male
                    and female rabbits at 5,000 mg/kg/day, 5 hours/day, 5 days/week.  No
                    systemic toxicity was observed; mild scaling and staining were  reported at
                    the test sites.               -.'

                    c.      Chronic toxicity,
                          Terbacil 80% a.i. was administered to beagle dogs (4/sex/group) in
                    the diet for 2 years, at doses of 50, 250, or 2,500/10,000 ppm, equivalent

-------
 to 1.25, 6.25, 62.5/250 mg/kg/day (MRID 00060851).  The NOEL was
 50 ppm (1.25 mg/kg/day), and the LOEL was 250 ppm (equivalent to 6.25
 mg/kg/day), based on increased thyroid to body weight ratios, slight
 increase in liver weights, and elevated alkaline phosphatase levels.  Relative
 liver weights were also increased at 2,500 and  10,000 ppm in dogs
 sacrificed at 1 year and 2 years.

       A 2-year rat study (MRID 42987601) was supplied to the Agency
 in response to the Registration Standard Data Call-in notice. In this study,
 terbacil 97.4% a.i. was administered to male and female Sprague-Dawley
 Crl:CD BR rats at dietary levels of 0, 25, 1500, or 7500 ppm (approximate
 doses for males of 0, 0.9, 58, and 308 mg/kg/day and for females of 0,
 1.4, 83, and 484  mg/kg/day). Ten animals/sex/dose were sacrificed by
 study design at 12 months. Excessive mortality was observed in the control
 and low dose groups, and the study was terminated at 23 months.  No
 clinical  signs relating to  dosing were reported.   Body weight  was
 significantly reduced in males receiving 7500 ppm and in females receiving
 1500 and 7500 ppm  throughout most of the study. At 51 weeks, body
 weight gain in males receiving 7500 ppm was 13 % lower than controls and
 in females receiving 1500 ppm and 7500 ppm gains were 18% and 39%
 lower  than in  controls.    No  lexicologically significant  changes in
 hematology parameters were observed.

       Serum cholesterol was significantly increased in high dose females
 at all reporting periods.  A  marginal increase was  observed in mid-dose
 females. A  slight increase was observed in 7500 ppm males at 18 and 24
 months but only the increase at 18 months was significant compared to
 controls.

       At 1500 ppm,  a significant increase in the mean liver to body
 weight ratio was observed in females at 12 months (16%) and at study
 termination  (21%). At  termination,  the  liver  weight increase  was
 accompanied  by  a marginally increased incidence  of centrilobular
 hepatocyte hypertrophy (minimal) and  a 20%  decrease in  mean body
 weight.  At 7500 ppm, significant increases in liver to body weight ratios
 were seen in both sexes at 12 and 23 months and  mean liver weight in
 males was 20% increased compared to controls at study termination.

       Centrilobular hypertrophy as well as fatty changes were seen in both
 sexes at the high dose and an increase in biliary hyperplasia was observed
in high  dose females.  Eosinophilic foci of cellular alteration in the liver
were increased in incidence  in dosed groups of male and females with a
significant trend.  However, this is of equivocal importance because it was
not accompanied by hypertrophic or hyperplastic changes or hepatocellular
                       8

-------
tumors. The systemic NOEL is 25 pjpm (0.9 mg/kg/day for males and 1.4
mg/kg/day for females) and the LOEL is 1500 ppm (56 mg/kg/day for
males  and 83  mg/kg/day for females)  based on the liver effects and
decreased body weight gain in  females.  The study  was conducted at
adequate dosages as demonstrated by the decrement in body weight gain in,
both sexes.  There was no evidence of increased tumor incidence in the
treated animals when compared to the controls.

d.     Carcinogenicity

       Terbacil has been tested in a chronic 2-year feeding/oncogenicity
study in mice (MRID 00126770) at doses of 0, 50,  1250, or 5000/7500
ppm (equivalent to 7, 179, 714/1071 mg/kg/day) The increase in dose
occurred after week 54.   A systemic NOEL of 50 ppm is based on the
LOEL of 1250 ppm which resulted hi mild hypertrophy of the centrilobular
hepatocytes, and decreased pituitary weights in males.  Pituitary weight
was also decreased hi high-dose females. There was an increased incidence
of lung neoplasms (adenomas and adenocarcinomas) in all treated male
mice, which was not dose-related;  hi addition, these tumors were within the
range of similar tumorss observed in historical control  mice.  Additional
information (MRID 42031601), provided by the registrant demonstrated
that, under the conditions of this study, administration of terbacil did not
significantly increase the  incidence of any proliferative  hepatocellular
carcinoma, single/multiple adenomas, or foci of cellular alteration, or
combined  hepatocellular  adenomas and carcinomas, in  either  sex.
Guideline requirements for 83-2 are satisfied by this information.

       Terbacil was also tested in the rat (MRID 42987601, described
under chronic feeding toxicity studies, above).  Under the study conditions,
terbacil did not induce any increase in  tumor incidence  in the treated
animals.                   ,

e.     Developmental Toxicity

       Terbacil has  been  tested  in rats  and  rabbits for its  potential to
produce developmental toxicity. Rats (MRID 00039001) were fed 0, 250,
1,250 or 5,000 ppm (equivalent  to 0,  12,5, 62.5 or 250 mg/kg/day) of
terbacil in the  diet from days 6 through 15 of gestation.  The study .was
graded core-Supplementary, because of concerns raised about an increased
number of pre-implantation losses  and increased hydronephrosisln fetuses
from the treated dams. These concerns were subsequently addressed by the
registrant to the satisfaction of the Agency.  The developmental NOEL was
250 ppm (12.5 mg/kg/day); the developmental LOEL of 1250 ppm (62.5
mg/kg/day) was based upon significantly decreased number of live fetuses

-------
 per litter, apparently due to fetal loss occurring before or near the time of
 implantation. The maternal NOEL was 250 ppm (12.5 mg/kg/day), based
 on decreased body weight at 1,250 ppm (62.5 mg/kg/day).

       Rabbits were given doses of  terbacil  of 0,  30,  200, or 600
 mg/kg/day by gavage, on gestation days 7 through 19 (MRID 00150945).
 The maternal NOEL was 200 mg/kg/day, based on maternal deaths (5 died
 and 2 were sacrificed in extremist at the LOEL of 600 mg/kg/day. The
 developmental NOEL was also 200 mg/kg/day based on decreased live fetal
 weights in the high dose group (i.e., 600 mg/kg/day).

 f .     Reproductive Toxicity

       Terbacil was tested in male and female rats at control (i.e., 0 ppm)
 and dietary levels of 50 or 250 ppm (equivalent to  2.5 or 12.5 mg/kg/day),
 over three generations (MRID 00060852).   The first  litter of  each
 generation was discarded, and the second litter bred to produce the next
 generation. The study was reviewed for the 1982 Registration Standard,
 and graded core-Supplementary, based on testing only 2 dose levels and the
 use of antibiotics on the test animals during the  study.  In  addition,
 necropsy records were not available for the first litters, and the breeding
 records were incomplete.  After addressing  these concerns (Ace. No.
 249455), the study was upgraded to core-Minimum (Tox. Doc. 003401),
 with a systemic NOEL of equal to or less than 50 ppm (2.5 mg/kg/day),
 based on the reduction of body weight gain in male offspring at the 250
 ppm dietary level.  Because the weight gain appeared at late periods in the
 study, and not in the early development of the offspring, this effect is not
 considered to be reproductive effect. No reproductive effects were seen
 at the highest dose tested, therefore, the NOEL for reproductive toxicity
 was equal to, or greater than 250 ppm (12.5 mg/kg/day).

 g.     Mutagenicity

       Terbacil technical  (96.1%) was tested and found negative for
 clastogenicity in a chromosomal aberration study in rat bone marrow cells,
 at doses up to 500 mg/kg (MRID 00157181). It was also  negative in a
 CHO (HGPRT) gene mutation assay (Ace. No.  260460) when tested up
 to cytotoxic levels, with and without S-9 activation (cytotoxicity > 3.0
 mM without activation;  > 2.75 mM with activation).  Terbacil technical
was also  negative for  unscheduled DNA synthesis when tested up to
cytotoxic levels (5 mM) in the rat.
                      10

-------
       h.    Metabolism

             Radiolabeled terbacil was tested in rats (MRID 40104702) in single
       doses of 6.5 or 500 mg/kg; 97 to 103% of radioactivity was recovered
       within 5 days: 70-86% in urine, and 28% in feces.  The major metabolites
       were glucuronide, sulfate, and N-acetylcysteine conjugates.  The primary
       metabolic"pathway is hydroxylation of the 6-methyl group to form the
       alcohol, which is conjugated to form the glucuronide (35% of the dose) and
       the  sulfate derivatives  (11%).   Terbacil js also  metabolized  to the 5-
       hydroxy intermediate,  which is  further conjugated to form  a.  sulfate
       derivative  (17%).

2.     Toxicological Endpoint of Concern Used in Risk Assessment

       a.     Reference Dose

             The reference dose (RfD) for systemic toxicity was determined for
       terbacil as 0.013 mg/kg/day, by the.* Agency's RfD Committee in May,
       1986. This was verified  by the Agency's Review Committee in June,
       1986. The RfD was calculated from a two-year feeding study in dogs
       (MRID 00060851)  in which the NOEL was 1.25 mg/kg/day (based on
       increased relative liver weights and increased serum alkaline phosphatase,
       seen at 7.25 mg/kg/day), and an uncertainty factor of 100.  The RfD of
       0.013 mg/kg/day was  reaffirmed by the Agency's RfD Committee on
       September 1, 1994.

       b.     Carcmogemcity Classification

             Terbacil was classified in Group E (no evidence of carcinogenicity
       in animal studies) with respect to its carcinogenicity potential.

       c.     Other Toxicological Endpoints

             Based upon  a review of the TES Committee, the database for
       terbacil,  a  toxicology endpoint and the  dose level of concern have been
       identified.  Findings of the TES Committee are discussed and summarized
       in the Table 3 below.
                            11

-------
Table 3: Summary of
Toxicological Endpoints for Terbacil
Exposure Duration
Acute
Short-Term (1-7 days)
Occupational/Residential
Intermediate-Term (one
week to several months)
Occupational/Residential
All time periods
Chronic
Exposure Route
Ingestion
Dermal
Dermal
Inhalation
Ingestion
Endpoiiit and Toxicological Effect
Developmental NOEL (12.5 mg/kg/day): based on a decrease in
number of live fetuses seen at 62.5 mg/kg/day in a rat
developmental study.
None identified.
None identified.
None identified.
RfD (0.013 mg/kg/day) based on increased thyroid: body weight
ratio, slight increase in liver weight and elevated alkaline
phosphatase seen at 7.2 mg/kg/day in a 2-year dog study.
                          (1)    Acute Dietary

                                To estimate acute dietary risk, the endpoint selected was
                          developmental  toxicity.   Female Sprague  Dawley  rats  were
                          administered terbacil at dietary doses of 250, 1250, or 5000 ppm
                          (12.5, 62.5 or 250 mg/kg) on gestation day 6 through 15 (MRID
                          No. 00039001).  The developmental NOEL was 250 ppm  (12.5
                          mg/kg/day); the  developmental  LOEL of  1250 ppm   (62.5
                          mg/kg/day) was based upon significantly decreased number of live
                          fetuses per litter, apparently due to fetal loss occurring before or
                          near the time of implantation.  The maternal NOEL was 250 ppm
                          (12.5 mg/kg/day), based on decreased body weight at 1250 ppm
                          (62.5 mg/kg/day).  A risk assessment for acute dietary exposure is
                          required.

                                It was noted that, although the compound was administered
                          for a period that exceeded one day, the study was selected for the
                          determination of acute dietary risk because it is uncertain whether
                          the observed developmental toxicity resulted from exposure on the
                          first day of dosing or resulted from cumulative exposure during the
                          10 day period that corresponded to organogenesis.

                          (2)    Dermal Absorption

                                Dermal absorption data were not available for terbacil. It
                          was assumed by the TES Committee that there would be  100%
                          absorption.
                                         12

-------
              (3)     Short and Intermediate Term Occupational

                     The results of a 3-week dermal study conducted with rabbits
              demonstrated that at doses as high as 5000 mg/kg/day, there were
              no toxic signs or histopathological lesions that could be associated
              with the administration of the test material. Furthermore, in a 90-
            *  day feeding study with rats (doses tested: 100, 500 and 5000 ppm)
              there appeared to be low toxicity associated with the administration
              of the compound  based  on the observation of adaptive hepatic
              alterations of increased liver weight and hepatic vacuolation and
              hypertrophy at 500 ppm (25 mg/kg/day).

                     Because of these results, the TES Document stated that risk
              assessments for both short and intermediate term occupational or
              residential exposure are not required.

              (4)     Chronic Occupational (Non-Cancer)

                     The TES Document (12/01/94) identified no chronic toxicity
              endpoints to assess chronic occupational exposure and risk.  A 2-
              year chronic feeding study  in dogs was used for establishment of the
              RfD (0.013 mg/kg/day) to  evaluate dietary exposures and risk.  The
              lowest exposure level at which effects were seen in this study was
              6.25 mg/kg/day.  Because the chronic dose level at which effects
              were seen is relatively high, coupled with the fact that the 2-year
              duration of the study is longer than normally required for chronic
              toxicity studies ( usually require only one year of dosing).

3.     Exposure Assessment

       a.      Dietary Exposure  (Food  Sources)

              Tolerances for residues of terbacil in/on apples, citrus, peaches,
       pears, and sugarcane are currently  expressed in terms of terbacil per se [40
       CFR §180.209(a)].  Tolerances for residues of terbacil on other plant and
       animal commodities are expressed  as the combined residues of terbacil and
       its  metabolites, 3-rerr-butyl-5-chloro-6-hydroxymethyluracil (Metabolite
       A), 6-chloro-2,3-dihydro-7-hydroxymethyl-3,3-dimethyl-5H-oxazolo (3,2-
       a) pyrimidin-5-one (Metabolite B), 6-chloro-2,3-dihydro-3,3,7-trimethyl-
       5H-oxazolo (3,2-a) "pyrimidin-5-one (Metabolite C), each calculated as
       terbacil [40  CFR §180.209(b)]. Tolerances range from 0.1 ppm for animal
       commodities, berries, and pecans to 5 ppm on forage and hay of alfalfa'and
       sainfoin.   No food/feed  additive tolerances have been established for
                             13

-------
                    residues of terbacil.  Adequate methods are available for the enforcement
                    of established tolerances, as currently defined.

                           The residues to be regulated in plants and animals are terbacil and
                    its three currently  regulated metabolites.  The chemical names and
                    structures of the terbacil residues of concern are depicted in Table 4.
Table 4: Terbacil and its Metabolites
 Common Name/Chemical Name
Chemical Structure
 Terbacil
 3-fert-butyl-5-chloro-6-methyluracil
                                                    ci
 Metabolite A

 IN-G2449

 3-te/t-butyl-5-chloro-6-
 hydroxymethyluracil
 Metabolite B

 IN-W2207

 6-chloro-2,3-dihydro-7-
 hydroxymethyl-3,3-dimethyl-5H-
 oxazolo (3,2-a) pyrimidin-5-one
         KOCH,
 Metabolite C

 IN-T2170

 6-chloro-2,3-dihydro-3,3,7-trimethyl-
 5H-oxazolo (3,2-a) pyrimidin-5-one
                          (1)    Directions for Use

                                A search of  the Agency's Reference Files on 9/27/96
                          indicates that there is one terbacil end-use product (EPA Reg. No.
                          352-317, label dated 3/5/96) with food/feed uses registered to E. I.
                          du Pont de Nemours & Company Inc.  This product is formulated
                                         14

-------
 as a 80% WP and is marketed under the trade name Sinbar®.  The
 following special local need (SLN) labels for use on alfalfa are
 associated with this product:  SLN Nos. OK920009,  OR920003,
 PA900003, VA900004, and WA'930007.  These SLNs should be
 canceled and the use directions incorporated into the federal label.
 Three additional SLN labels are registered for use on grasses grown
 for  seed (SLN Nos.  ID800009,  OR800021,  and WA800010).
 These labels prohibit the grazing of treated fields and the feeding of
 seed or crop residues from treated areas to livestock.  Given the use
 in only three states in the Pacific Northwest and the limited number
 of varieties on which use is permitted, the Agency believes that this
 restriction is appropriate in this instance.

        Under the "General Information" section of the label (EPA
 Reg. No. 352-317), pecans are fisted as a crop to which Sinbar®
 can be applied; however, no use directions for pecans are included
 on the label.  The reference to pecans should be deleted from the
 label.  In addition,  a 150-day preharvest interval (PHI) should be
 specified for sugarcane and a 60-day PHI should be specified for
 apples. The label instructions for asparagus should be clarified to
 indicate a maximum seasonal rate of 3 Ibs a.i./A.

 (2)    Nature of the Residue in Plants

       The qualitative nature  of the residue in plants is adequately
 understood based on alfalfa, blueberry, arid sugarcane metabolism
 studies.  The residues to be regulated in plants are terbacil and its
 metabolites A, B; and C.

 (3)    Nature of the Residue in Livestock

       The qualitative nature of the residue in animals is adequately
understood based upon acceptable ruminant and poultry metabolism
studies,, The  residues  of concern in animals are terbacil and its
metabolites A, B, and  G. However, the Agency has determined
that based on CFR part  180.6(a)(3), there is no likelihood of finite
residues.   Therefore,  tolerances in these commodities are  not
necessary (see "Magnitude of the Residue in Meat, Milk, Poultry,
and Eggs").

(4)    Residue Analytical Methods

       Adequate  analytical  methodology  is  available for data
collection and enforcing  terbacil tolerances.   Method I in  the
                15

-------
 Pesticide  Analytical  Manual   (PAM),   Vol.   II,   is   a
 GLC/microcoulometric detector (MCD) method that determines
 terbacil per se and  has  undergone a successful EPA method
 validation on oranges and peaches.  As metabolites A, B, and C are
 not determined by Method I, this method is no longer adequate for
 tolerance enforcement.  .

       Method n in PAM,  Vol. n determines terbacil and its three
 regulated metabolites in plants and has undergone a successful EPA
 method  validation on alfalfa.    Residues are  extracted into
 chloroform, further purified, and then silylated for GC analysis.
 Silylated residues are quantified by GC using a halogen-sensitive
 microcoulometric detector.  The reported  limits of detection for
 each analyte are 0.1 ppm in mint oil and hay and 0.04 ppm in other
 plant commodities.  A confirmatory GC/MSD method is also listed
 in PAM Vol. H as Method A.
     »-
       Data from analysis  of terbacil residues in/on plants have
 been collected using PAM Methods I and IE, and more recently
 using an adequate GC/nitrogen-phosphorus detector (NPD) method,
 which is a modification of Method II in PAM.  For this GC/NPD
 method, residues of terbacil and its metabolites are extracted into
 chlorofbrmrwater and cleaned-up by liquid-liquid partitioning prior
 to derivatization with  bis(trimethylsilyl)trifluoroacetamide and
 trimethylchlorosilane (BSTFA +1% TMCS).  Silylated residues
 are then further purified using sodium sulfate and Florisil columns
 and then quantified by GC/NPD.  The reported limit of detection
 is 0.05 ppm for each analyte.

       As Method I in PAM is no longer an acceptable enforcement
 method  and  Method  n utilizes  an obsolete  microcoulometric
 detector,  the Agency will require the registrant  to submit the
 GC/NPD method for a Tolerance  Method Validation prior  to
 inclusion in PAM as an enforcement method.  As the method is an
 improved method, we will not require that DuPont conduct any
 independent method validation.

 (5)     Multi-residue Method Testing

       Data have  been submitted pertaining  to  the  analytical
behavior of terbacil and its regulated metabolites through FDA
 Multiresidue  Protocols and have  been forwarded to FDA for
inclusion in PAM Vol. I.  The registrant has submitted the results
of FDA Multiresidue Protocol C to the Agency (Protocols A, B,
               16

-------
 and E are not applicable) which demonstrates that terbacil and its
 metabolites are completely recovered. Results from Protocol D
 were not submitted, and the registrant is required to use this method
 to test an appropriate commodity and submit the results for terbacil
 and its regulated metabolites for inclusion in PAM.

 (6)    Storage Stability Data

       Requirements for storage stability data  are satisfied for
.purposes  of reregistration.   Adequate storage stability data have
 been submitted  for terbacil residues in RACs commodities of.
 alfalfa, apples, blueberry, mint, milk, and sugarcane. These data
 indicate that terbacil and metabolites A, B, and C are stable in
 alfalfa at -20 C for up to 24 months, in frozen (<0 C) apples,
 blueberries, and sugarcane for up to 6 months, in frozen (<0 C)
 mint for up to 18 months, and in frozen milk for up to  1 month.
 Storage  stability  data  on  blueberries  can  be  translated  to
 caneberries, peaches,  and strawberries.   The  Agency has also
 concluded that terbacil residues are stable in frozen asparagus and
 grass (forage, fodder, and hay) for up to  18 months based upon
 storage stability data translated from alfalfa and mint.

 (7)    Magnitude of the Residue in Crop Plants

       For purposes of reregistration, requirements for magnitude
 of the residue in plants are fulfilled for the following crops: alfalfa,
 apples, asparagus, blueberries, caneberries, grass (grown for seed),
 mint, peaches,  and sugarcane.  Adequate field trial data depicting
 terbacil residues following applications made  according  to the
 maximum or proposed use patterns have been submitted for these
 commodities.     Geographical representation is adequate and a
 sufficient  number of trials were conducted.

 (8)    Magnitude of the Residue in Processed Food/Feed

       The reregistration requirements for magnitude of the residue
 in processed food/feed commodities are fulfilled for apple and mint.
 Based on  these studies, tolerances are not required on apple and
 mint processed commodities.

       Data are required depicting the potential for concentration
 of terbacil and its metabolites in blackstrap molasses processed from
 sugarcane bearing detectable terbacil residues.
                17

-------
       As the use on citrus fruits has been deleted from the label,
 the  requirement  for a  citrus processing study  is  no  longer
 applicable.

 (9)    Magnitude of the Residue in Meat, Milk, Poultry, and
       Eggs

       The requirement for a poultry feeding study has been waived
 because the Agency has determined there is no likelihood of finite
 residues based upon the  results of the poultry metabolism study
 which used a 65x feeding level.

       Currently alfalfa forage and hay are the only livestock feed
 items having a registered use and established tolerances (the SLN
 uses on grass grown for  seed prohibit the grazing or feeding of
 treated forage  or hay to  livestock—see  "Directions  for  Use"
 section).  The Agency concludes that terbacil residues in ruminant
 commodities  show  no  likelihood  of finite  residues.    The
 requirement  for a ruminant  feeding study is waived and the
 established animal tolerances should be revoked.

 (10)   Magnitude of the Residue in Water, Fish, and Irrigated
       Crops

       Presently, terbacil is not registered for direct use on potable
 water  and aquatic food  and  feed  crops;  therefore,  no residue
 chemistry data are required under this guideline topic.

 (11)   Magnitude   of  the   Residue    in   Food-Handling
       Establishments

       Terbacil is  not  registered  for  use   in  food-handling
 establishments; therefore, no residue  chemistry data are required
 under this guideline topic.

 (12)   Confined Accumulation in Rotational Crops

       Data were' required depicting the nature of terbacil residues ,
in confined rotational crops.   As a result of the aerobic soil
metabolism study reviewed, the Agency considers this guideline
fulfilled.                         ,

 (13)    Field Accumulation in Rotational Crops

       Since the limited rotational field trials indicated that residues
of concern can potentially be present in rotated crops planted at the

                18

-------
       labeled  2ryear plant-back interval  at levels  >  0.01 ppm, then
       extensive field rotational crop studies could be required.  The
       Agency will instead require that these additional limited rotational
       studies be performed with crops to which rotations are likely (corn,
       and soybean). If residues of concern appear in these rotated crops,
       then establishment of rotational crop tolerances will be required.

b.     Dietary Exposure (Drinking Water Sources)       <

       (1)    Ground water

             (a)     Acute Exposure

                    Using the Ground Water Interactive Concentration
             (GWIC) screening model, the concentration of terbacil in
             shallow groundwater is not expected to exceed 125 fig/L for
             most uses.  There are a number of uncertainties with this
             model,  including  that  the  predicted   ground  water
             concentrations are linearly extrapolated from the application
             rate, with no consideration of hydrology, soil properties,
             climatic conditions,  agronomic practices, or volatilization.
             For this reason, the estimated GWIC value from this model
             can be used as an upper bound for the acute ground water
             exposure assessment calculations.

                    If the maximum estimated GWIC level (125 ^g/L or
             0.125 mg/L) is assumed, acute exposure from the ingestion
             of terbacM-contaminated ground water can be calculated for
             the most sensitive sub-population (60 kg female, age 13+
             years) as follows:

             For a 60 kilogram female, consuming 2 Liters  per day

             Exposure = (0.125 mg/L x 2 L/day) -5-  60 kg = 0.004
             mg/kg/day

             (b)    Chronic Exposure

                   The EPA Pesticides hi Ground Water Database (EPA
             734-12-92-001, September 1992) reports only 6 detects  of
             terbacil (ranging from 0.3 to 8.9 ^g/L) out of 288 wells
             tested hi six states (i.e., California, Louisiana, Mississippi,
             Oregon, Washington, and West Virginia).  One reason for
     v       low frequency of detections of terbacil in some of the
                     19

-------
        available ground water surveys is high minimum detection
        limits.   In most of the state surveys, terbacil minimum
        detection limits have been 5 to 100 times higher (i.e., less
        sensitive) than detection limits that have been achieved in
        recent surveys for most widely used herbicides.  Another
        reason why terbacil should not be detected frequently in
        general ground water surveys is  because  only  a small
        percentage of the overall agricultural acreage in the United
        States is treated with terbacil in a given year.

              While limited ground water data exist, they do give
        some indication of the potential presence of terbacil in
        drinking   water sources,  and   are  therefore  used  as
        representative of actual ground water concentrations in the
        chronic exposure calculations below.

            '  If the maximum detected level (8.9 peg/Lor 0.0089
        mg/L) is assumed, chronic exposure from the ingestion of
       terbacil-contaminated ground water can be calculated for the
       general U.S. population and for children, as follows:

       For the U.S population:

       Exposure (mg/kg/day) = (0.0089 mg/L x 2 L/day) / 70 kg
        = 0.00025 mg/kg/day

       For a 10-kilogram child, consuming 1 Liter per day

       Exposure (mg/kg/day) = (0.0089 mg/L x 1 L/day)/  10 kg
       = 0.00089 mg/kg/day

(2)    Surface Water

       Two environmental concentration models were used to
estimate exposure to terbacil via ingestion of surface water:  a tier
one model named, GENEEC (GENeric Expected Environmental
Concentration), and a tier two model named, PRZM 2.3.  Risk
calculations for surface water appear later in this section.

       (a)    Acute Exposure
               i
             GENEEC estimates expected concentrations from a
       few  basic  chemical  parameters  and  pesticide  label
       application  information.   GENEEC uses a  chemical's
       soil/water partition  coefficient and degradation  half-life
               20

-------
 values to estimate runoff from a ten-hectare agricultural
 field into a one-hectare by two-meter-deep pond.  GENEEC
 considers reduction in dissolved pesticide concentration due
 to adsorption of pesticide to soil or sediment, incorporation,
 degradation in soil before wash off to a water body, direct
 deposition  of  spray drift  into  the water body, and
 degradation of the pesticide within the  water  body.
 GENEEC  was  designed for  use  in  ecological  risk-
 assessment  and,  therefore,  it could  substantially over-
 estimate the  actual drinking water concentrations. Because
 of its conservative values, output from this model is used in
 the acute exposure calculations below.

       The  GENEEC model  gives  the peak  Estimated
 Environmental Concentrations (EEC) of terbacil in surface
 water as 0.154 ppm (0.154 mg/L). Using this value, acute
 exposure  from ingestion.of terbacil-contaminated surface
 water can be calculated for the most sensitive subpopulation
 (females,  13+years) as follows:                ,

 Exposure = (0.154 mg/L x 2 L/day) / (60 kg) = 0.005
 mg/kg/day

 (b)    Chronic Exposure

       PRZM 2.3, linked with a program named, EXAMS,
 models pesticide concentrations in surface water  associated
 with usage  on a given crop, in  a given  geographical
 location.  Soil and hydrologic input parameters are used,
 and  dissipation is projected  on a yearly basis, over the
 period 1948 through 1983.  Volatilization, soil binding and
 photodegradation  predictions  are   used   to   calculate
 dissipation rates.  Risk calculations for chronic exposure to
 terbacil-contaminated surface  drinking water that appear
 later in this chapter,  are  based  on the output from the
 PRZM/EXAMS model because it represents a more refined
 upper bound estimate of concentrations of terbacil  in surface
 water than GENEEC.

      PRZM/EXAMS,   like  GENEEC,   also   may
 overestimate concentrations of pesticides in drinking water.
 This model uses input parameters and assumptions that
represent   worst   case   scenarios.     For   example,
 PRZM/EXAMS  models a static pond system,  where
         21

-------
 dissipation from outflow and aerobic aquatic metabolism are
 not factored in, nor is any other active degradation process
 other than photodegradation. Because of the static nature
 of the model, yearly concentration estimates increase with
 each successive year due to accumulation.  The Agency
 determined the average annual incremental increases in
 predicted surface water terbacil concentrations due to this
 accumulation factor,  for the  major  crop uses,  e.g.,
 Louisiana sugarcane (36 pig/L) and New York apples (4
       For the purpose of calculating chronic exposure to
 terbacil-contaminated surface drinking water, the Agency
.has chosen to  use a value from analysis of the 36-year
 period of terbacil use on sugarcane because this end-use
 resulted in the highest predicted concentrations.  The last
 year of the model's 36-year analysis of sugarcane reflects
 the accumulation  of terbacil  at  an average incremental
 increase of 36 jtg/L/year. The Agency believes that a more
 reasonable and representative value to use is the value for
 the first year of the analysis.  This value is conservative
 because of all the previously mentioned conservative input
 parameters, and because it comes from the highest end-use
 values.   However, it does not incorporate the  36 /tg/L
 annual accumulation factor which is unlikely to be seen in
 an open system.  (It should be noted that STORET data also
 suggest that terbacil is not accumulating in surface water.)

       The PRZM/EXAMS model gives the maximum EEC
 for the first year of the 36-year sugarcane analysis as 105
 Atg/L (105 ppb). Using this value, chronic exposure from
 ingesting terbacil-contaminated surface drinking water can
 be calculated as follows:

 For the U.S population:

 Exposure (mg/kg/day)  = (0.105 mg/L x 2 L/day) / 70 kg
 = 0.003 mg/kg/day

 For a 10-kilogram  child, consuming 1  Liter .per day
        *                            \
 Exposure(mg/kg/day) = (0.105 mg/L x 1 L/day) / 10 kg
 = 0.0105 mg/kg/day
         22

-------
 4.     Dietary Risk Assessment
                -•               /                 - .
       a.     Toxicologic Endpoints

              The Reference Dose  (RfD) used in the analysis is 0.013 mg/kg
       bwt/day, based on a NOEL  of 1.25 mg/kg bwt/day (and an uncertainty
       factor of 100) from a two-year feeding study in dogs that demonstrated
       increased relative liver weights, increased thyroid : body weight ratio and
       elevated alkaline phosphatase as endpoints.

              Terbacil is classified as a Group E carcinogen.

              The endpoint for acute dietary risk assessment is a developmental
       toxiciry NOEL of 12.5 mg/kg bwt/day from a dietary study in rats, based
       upon a significantly decreased  number of live fetuses per litter at the LOEL
       of 62.5 mg/kg bwt/day.

       b.     Residue Information

              Tolerances for residues of terbacil are expressed in terms of
       terbacil per se in/on apples, pears and sugarcane and published in 40 CFR
       §180.209(a).  For other  plant and animal commodities, tolerances are
       currently expressed as the combined residues of terbacil and its metabolites
,       A, B, and C in  40 CFR §180.209(b).  No food/feed additive tolerances
       have been established for residues of terbacil.
                                                   /                   ,
       c.      Chronic Exposure/Risk (TMRC)

             A DRES  chronic exposure analysis was performed using tolerance
       level residues and a 100 percent crop treated  assumption to estimate the
       Theoretical Maximum Residue Contribution (TMRC) for the general
       population and 22 subgroups.   No anticipated residue (AR) information
       was used in this  analysis.

             Existing tolerances result in a TMRC which represents 12.2 % of the
       RfD for the U.S. general population. The highest subgroup, Non-Nursing
       Infants (< 1 year old) occupies 62.3% of the RfD.

             Incorporating the recommendations of the Agency (i.e., to xevoke
       tolerances for citrus fruits and pears, and to raise tolerances on caneberries,
       blueberries, peaches, apples and sugarcane), results in  a TMRC which
       represents 4.5%  of the  RfD  for the U.S. general population..  For the
       highest subgroup, Non-Nursing Infants (< 1 year old),  24.6% of the RfD
       is occupied.                                              .
                            23

-------
       The analysis for terbacil is a worst case estimate of dietary exposure
 with all residues at tolerance level and 100 percent of the commodities
 assumed to be treated with terbacil.  For both existing published tolerances
 and incorporating the changes recommended by the Agency, it appears that
 chronic dietary risk from the uses supported in reregistration, is not of
 concern.

 d.     Acute Exposure/Dietary Risk

       Two acute analyses were performed showing  results from all
 presently   registered   commodities   and   results   following   the
 recommendations of the Agency.

       The Margin of Exposure (MOE) is a measure of how close the high
 end exposure comes to the NOEL (the highest dose at which no  effects
 were observed in the laboratory test), and is calculated as the ratio of the
 NOEL to the  exposure  (NOEL/exposure = MOE).  Generally, acute
 dietary margins of exposure greater than 100 tend to cause no dietary
 concern.  Because the endpoint of concern was a developmental effect, the
 only sub-population of concern is females of child bearing  age (i.e.,
 females,  13+ years old). The NOEL used in the calculation is from an
 animal study.  In determining  the high end exposure values below,  the
 formula includes the relative dose value (RDV), which is a code chosen to
 cause the DRES model to create an appropriate spreadsheet of estimated
 values.

 Presently registered commodities result in a MOE for Females (13+
 years) of 3125

 High End Exposure = RDVxX
                   = 0.001 x 4
                   = 0.004

 MOE = NOEL +  Exposure
MOE =  12.5 mg/kg/day + 0.004 mg/kg/day. = 3125

Following the recommendations  of the Agency results in a MOE of
terbacil for Females (13+ years) of 4166

High End Exposure = RDV x X
                   = 0.001 x 3
                   = 0.003                                      ;

MOE = NOEL -s-  Exposure
                      24

-------
 MOE = 12.5 mg/kg/day -s- 0.003 mg/kg/day = 4166

 The MOE values demonstrate that there is no cause for concern regarding
 the acute dietary exposure from terbacil for existing uses.

 e.     Drinking Water Risk (Ground Water)

        (1)     Acute Risk

               The highest concentration of terbacil in shallow groundwater
       • predicted by the Ground Water Interactive Concentration (GWIC)
   :     screening model (0. 125 mg/kg/day), results in an acute exposure of
        0.004 mg/kg/day. Using this value, acute risk from ingestion of
        terbacil-contaminated ground water, expressed as the Margin of
        Exposure (MOE), can be  calculated for the most sensitive sub-
        population as follows:

        For a female (13+ years'),  weighing 60 kg. and ingesting 2 liters
        per day:                                                '

        MOE = (NOEL)/(Exposure)
        MOE = (12.5 mg/kg/day)  / (0.004 mg/kg/day) = 3100

        (2)     Chronic Risk

               Chronic exposure levels had previously been derived by
        using the maximum detected terbacil level (0.0089 mg/L) in EPA's
        Ground Water Database. Using these values^ chronic risk from the
        ingestion  of terbacil-contaminated ground water can be calculated
        for the general U.S.  population and for children, as follows:

        For the U.S. population:

        % RfD =  (Exposure + RfD) (100)
        % RfD =  (0.00025  + 0.013) (100) = 2  %

        For a 10-kg child:  .

        %RfD  =  (Exposure  + RfD) x 100
        %RfD  =  (0.00089 mg/kg/day *  0.013 mg/kg/day) x 100 = 7
 f.     Drinking Water Risk (Surface Water - Acute)

       The estimate of acute exposure derived from the GENEEC model's
 peak EEC of terbacil in surface water is 0.005 mg/kg/day.  Using this

'  -  •     •       '  .     25                 -.".'•

-------
       value, acute risk from ingestion of terbacil-contaminated surface water,
       expressed as the Margin of Exposure (MOE), can be calculated for the
       most sensitive sub-population as follows:

              For a female (13+ years), weighing 60 kg. and ingesting 2 liters
              per day:

              MOE = (NOEL)/(Exposure)
              MOE = (12.5  mg/kg/day)  / (0.005 mg/kg/day) = 2500

       g.     Drinking Water Risk (Surface Water - Chronic)

              A chronic surface drinking water exposure value for terbacil was
       derived  from  the  first  year  annual maximum  EEC   from  the
       PRZM/EXAMS model for terbacil use on sugarcane.  Using this estimated
      . value, the upper bound chronic risk from ingesting terbacil-contaminated
       surface water (expressed as %RfD) is calculated as follows:

              For the U.S. population:

              % RfD =  (Exposure -s-  RfD) (100)
              % RfD =  (0.003 + 0.013) (100) =  23 %

              For a 10-kg child:

              %RfD = (Exposure -s- RfD) x 100            -  .   .
              %RfD =  (0.0105 mg/kg/day -s- 0.013 mg/kg/day) x 100  = 81 %

              In summary, the Agency usually has no concerns when less than
       100% of the RfD has been used.  Even using upper bound estimates, none
       of drinking water scenarios analyzed abpve exceeds 100% of the RfD.
       Because of this,  and the fact that  actual  ground  water monitoring data,
       although limited, are not showing  large amounts of terbacil present, the
       Agency does not believe that drinking water sources of terbacil are of
       concern.

5.     Occupational Exposure and Risk Assessment

      An occupational exposure assessment is required  for an active  ingredient
if (1) certain lexicological criteria are triggered and (2) there is potential exposure
to handlers (mixers, loaders, applicators, etc.) during use or to persons entering
treated sites after application is complete.   The Toxicity Endpoint Selection
Committee found that neither dermal nor inhalation toxicity criteria were triggered
                             26

-------
for terbacil. Therefore, no assessments are needed for occupational exposure/risk
at this time.

       a.     Summary of Use Patterns and Formulations

              Terbacil,  3-tert-butyl-5-cMoro-6-methyluracil,  is  a  herbicide
       formulated as a wettable powder (20 percent a.i.).  Terbacil is used on
       terrestrial  food/feed crops  (apples,  mint/peppermint/spearmint,  and
       sugarcane),   terrestrial  food  (asparagus,  blackberry,  boysenberry,
       dewberry, loganberry, peach, raspberry,  youngberry, and strawberry),
       terrestrial feed (alfalfa, forage, and hay) and on forest trees (cottonwood).
       Terbacil can be applied by aircraft and ground equipment (band treatment,
       broadcast, direct sprays).  The maximum application rates range from
       0.264 to 3.2 LB a.i./acre, with the-lower  rates generally usfed on coarse
       textured soils and higher rates on fine textured  soils.

       b.     Occupational-use products and homeowner-use products

              At this time products containing terbacil  are intended primarily for
       occupational uses and are not registered for residential use, thus eliminating
       concern for homeowner exposure.

       c.     Additional Occupational Exposure Studies

              Data on worker exposures to terbacil have not been submitted to the
       Agency.  However,  worker exposure studies are not required at this time
       since there are no lexicological endpoints of occupational concern identified
       for terbacil.

6.     Food Quality Protection Act Considerations

       a.     Potential Risks to Infants and Children

              EPA uses a weight of evidence approach in determining whether an
       additional uncertainty factor is or is not appropriate for assessing risks to
       infants and children; taking into account the  completeness and adequacy of
       the toxicity data base, the nature and severity of the effects observed in pre-
       and post-natal studies, and other information such as epidemiological data.

              For purposes  of assessing the pre- and post-natal toxicity of terbacil,
       EPA has evaluated two developmental studies and one reproduction study.
       Based on current lexicological data requirements, .the data base for terbacil
       relative to pre- and post-natal toxicity is complete. However, as EPA fully
       implements .the requirements of FQPA, additional data related to the special
       sensitivity of infants and children may be required.

                             27                     :

-------
 (1)     Developmental and Reproductive Effects

        (a)    Developmental Toxicity

              In  the  rat developmental  toxicity  study,  the
        developmental NOEL was 250 ppm (12.5 mg/kg/day); the
        developmental LOEL of 1250 ppm (62.5 mg/kg/day) was
        based upon significantly decreased number of live fetuses
        per litter, apparently due to fetal loss occurring before or
        near the time of implantation.  The maternal NOEL was 250
        ppm (12.5 mg/kg/day), based on decreased body weight at
        1,250 ppm (62.5 mg/kg/day).

              In the rabbit developmental toxicity study, the
        maternal NOEL was 200 mg/kg/day,  based on maternal
        deaths (5 died and 2 were sacrificed in extremist at the
        LOEL of 600 mg/kg/day.  The developmental NOEL was
        also 200 mg/kg/day based on decreased live fetal weights in
        the high dose group (i.e., 600 mg/kg/day).

        (b)    Reproductive Toxicity

              In a multigenerational reproductive toxicity study
       with rats,  the systemic NOEL of  < 50 ppm (2.5
       mg/kg/day) was based on the reduction of body weight gain
       in males. The NOEL for reproductive toxicity was  > 250
       ppm (12.5 mg/kg/day).

(2)    Uncertainty Factor

       Because the developmental NOELs were the same as those
for maternal toxicity, and the NOEL for systemic (parental) toxicity
was higher than the NOEL for reproductive toxicity, these data do
not suggest an increased pre- or post-natal sensitivity of children
and infants to terbacil exposure. Therefore, the Agency concludes
that the available toxicology data do not support an uncertainty
factor of 1000 as specified in FQPA and that the present uncertainty
factor of 100 is adequate to ensure the protection of infants and
children from exposure to terbacil.

(3)    Aggregate Exposure/Risk

       Products containing terbacil are not registered for residential
use at this time. With regard to  occupational risk, no dermal or
               28

-------
 inhalation endpoints of concern were identified and an assessment
 is  not  needed.   Therefore,  the following  aggregate  risk
 determinations are for dietary exposures only (from food and
 water).

 (4)    Total dietary (food source and drinking water)

    ,  Food source data are taken from the DRES Tables.
 Drinking water figures are taken from calculations presented  in
 sections 4 f. and g. above.

 Determination of Safety for U.S. Population rGhronicV

 Aggregate Exposure = %RfD (food sources) +   %RfD (surface
 drinking water)           ,
                    = 4.6% +  23%
                    = 27.6%
 For 10-kg children (I to 6 years')
 Aggregate Exposure = %RfD (food sources) +  %RfD (surface
 drinking water)

                    =  12.8% + 81%
                    =  93.8%
For females (13+ years old")
Aggregate Exposure  =  dietary exposure  +   drinking  water
exposure  '
                    = 0.003 mg/kg/day + 0.005 mg/kg/day
                    = 0.008 mg/kg/day

Aggregate MOE = NOEL + Aggregate Exposure
               = 12.5 mg/kg/day + 0.008 mg/kg/day
               = 1563

Conclusions:                      ,

      Aggregate exposure/risk values are all below the level of
Agency concern.  This includes the acute exposure of females of
child-bearing age.
               29

-------
b.
Cumulative Effects
       In assessing the potential risk from cumulative effects of terbacil
and other chemical  substances, the Agency  has considered structural
similarities that, exist between terbacil  and  other  substituted uracil
compounds such as bromacil and lentacil.

       A comparison of the available lexicological database for terbacil and
bromacil revealed no clear common mode of toxicity these chemicals.  The
toxicology database  for lentacil was  not considered  because there are
currently no registered uses of lentacil. A summary of the most prominent
clinical signs from terbacil and bromacil follows.

       The following clinical signs were observed in the terbacil toxicology
database: decrease in body weight, increase in liver weights, vacuolization
and hypertrophy of hepatocytes, hypertrophy of centrilobular hepatocytes
in males, decreased pituitary weights  in males and females,  increase in
thyroid/body weight ratio, elevated alkaline phosphatase.

       The following  clinical  signs  were observed  in the bromacil
toxicology database: decreased body weight, focal atrophy of seminiferous
tubules (testicular abnormalities), hydronephrosis, suggestive histological
evidence for antithyroid activity  (cystic follicles in the thyroid and
enlargement of centrilobular cells of the liver) and a positive trend in
thyroid tumors for male rats (basis of C classification for carcinogenicity).

       Based on these data, the Agency has determined that there is no
clear common mode  of toxicity (thyroid or liver) between terbacil and
bromacil. With both chemicals, there is marginal evidence of liver effects
(principally enlargement of centrilobular cells).  Enlargement of liver cells
is not a specific enough effect to be considered a common mode of toxicity.
The thyroid effects observed with bromacil were cystic follicles.  Terbacil
induced an  increase in relative thyroid weights but  no increase in absolute
thyroid weights.  An increase in relative weight without a corresponding
increase in absolute weight has very little meaning, especially without any
supporting histological or hormonal evidence.  This conclusion was based
on  the marginal liver effects noted in the databases, and .the  absence of
thyroid effects in the  terbacil database (with the exception of increases in
relative thyroid weights).

       EPA has found no information indicating that any other chemical
has a common mode  of toxicity with terbacil.  Therefore, aggregate risk
assessment will indicate risks resulting only from terbacil.
                       30

-------
        C.     Environmental Assessment
               1.     Ecological Toxicity Data

                      All ecological toxicity data are fulfilled except for chronic avian and aquatic
               toxicity studies (71-4 Avian Reproduction Study; 72-4 Fish Early Life Stage and
               Aquatic Invertebrate Life Cycle).  These data are-needed because terbacil is a
               persistent compound which may pose long-term exposure in terrestrial and aquatic
               environments. Wild mammal toxicity study (71-3) is reserved pending the results
               of avian reproduction studies (71-4).

                      a.      Toxicity to Terrestrial Animals

                             (1)    Birds, Acute and Subacute

                                   An acute oral toxicity study using the technical grade of the
                             active ingredient (TGAI) is required to establish the toxicity of
                             terbacil to birds.  The preferred test species is either mallard duck
                 ,.   •       .(a waterfowl) or bobwhite quail (an upland gamebird). Results of
                             this test are tabulated  in Table 5 below.
Table 5: Avian Acute Oral Toxicity
Species
Northern bobwhite quail
(Colinus virg inianus)
%s.i>
96.1
£*>so
C»B/kg)
i>2250
Toxfc% Category
Practically non-toxic
MSBONo.
Author/Year
ace. 157177
Beavers, 1986
Sfcidy
Classification1
Core
                                   Terbacil is practically non-toxic to avian species on an acute
                            oral basis.  The guideline (71-1) is fulfilled. (Accession # 157177).
                            Two  subacute  dietary studies using the TGAI are required  to
                            establish the toxicity of Terbacil to birds.  The preferred test
                            species are mallard duck and bobwhite quail.  Results of these tests
                            are tabulated in Table 6 below..
Table 6: Avian Subacute Dietary Toxicity
Species
Peking mallard
Pheasant
Mallard duck
(Anas platyrhynchos)
.,-%aJL
80 WP
80 WP
96
S-BayJLC^
tepmj
> 56,200
26,4262
>50003
Toxicity
Category
practically
non-toxic
practically
non-toxic ,
practically
non^-toxic
MXOD No, Author/Year
00012347 Wazeter, 1966
00012346 Wazeter, 1966
ace. 241 146 Moore, 1979
Study ,
Classification1
supplemental
(formulated product)
supplemental
(formulated product)
core
     >    "        v — ^^   f	fXT —--——"—— ^»*-»-—:j **f u««^«^L&MuijL«^ujL«.jr '7*>.**r*iisjj L/ui KM^^o UUL ouUoJ.V c£illUwJJXlC«
 It is unclear if the reported concentration is based on the formulated product or on .active ingredient.  The number
corrected for percent active (80%) would be 21,141  ppm.
3No mortality was observed at the 5000 ppm concentration.
                                            31

-------
       Terbacil  is practically non-toxic to aviah species on a
 subacute dietary basis.  The guideline (71-2) is fulfilled (MRID
 00012347, 00012346, Ace. 241146).

 (2)    Birds, Chronic

       Avian reproduction studies using the TGAI are required for
 terbacil because the birds may be subject to repeated or continuous
 exposure to terbacil due to the persistence, especially preceding or
 during the breeding season.  The preferred test species are mallard
 duck and bobwhite quail. There are, currently, no data from avian
 reproduction studies.   These studies are outstanding.  The 71-4
 Avian Reproduction data requirement is not fulfilled.

 (3)    Mammals

       Wild mammal testing is required on a case-by-case basis,
 depending on the results  of lower tier laboratory  mammalian
 studies,  intended use pattern and pertinent environmental  fate
 characteristics. In most cases, rat or mouse toxicity values obtained
 from the Agency's Health Effects Division (HED) substitute for
 wild mammal testing.  These toxicity values are reported in Table
 7 below.
Table 7: Mammalian Toxicity
Species/
Study Duration
Rat(Rattus
norvegicus)
Rat
% I
44.
80
80
Test
(type
Acute oral
3-generation
rat study
Toxicity
Value
LDSO>5,000
mg/kg
NOEL> 250
ppm
Affected Endpoints
none
The NOEL for reproductive toxicity
was > 250 ppm (12.5 mg/kg)
MRJJJNo.
Ace. #114693
and 24955
Ace. No.
249455
The results indicate that terbacil is practically non-toxic to small
mammals on an acute oral basis.

(4)    Insects

       A honey bee acute contact study using the TGAI is required
for terbacil because its use (apple, alfalfa,  peach, caneberry,
strawberry, mint, and sugarcane) will result in honey bee exposure.
Results of this test are tabulated in Table 8 below.
                32

-------
Table 8; Nontarget Insect Acute Contact Toxicity
Species •.
Honey bee
(Apis meUifera)
%a.t«
80 WP
UV
<#g/)bee)
193
Tori<% Category
practically non-toxic
MBIDKo.
Author/Year
00018842
Atkins, 1969
Study
Classification
core
                                  The results indicate that terbacil is practically non-toxic to
                           bees on an acute contact basis; The guideline (141-1) is fulfilled
                           (MRID 00018842).

                    b.     Toxicity to Aquatic Animals
                           w      ,
                           (1)     Freshwater Fish, Acute

                                  Two freshwater fish toxicity studies using the TGAI are
                           required to establish the toxicity of terbacil to fish.  The preferred
                           test species are rainbow trout (a coldwater fish) and bluegill sunfish
                           (a warmwater fish). Results of these tests are tabulated in Table 9
                           below.
Table 9; Freshwater Fish Acute Toxicity
Species (all of testing
below are Static)
Rainbow trout
(Oncorhynchus mykiss)
Bluegill sunfish
(Lepomis macrochirus)
Bluegill sunfish
(Lepomis macrochirus)
Rainbow trout
(Oncorhynchus mykiss)
Rainbow trout
(Oncorhynchus mykiss)
Carp (48 hr.)
Japanese Goldfish (48 hr.)
Killifish (48 hr.)
Loach (48 hr.)
%a.i*
96.6
96.6
80
80
80
80
80
964t0nr:LC.p
(ppm) (nominal)
46.2
102.9
112
79
54
96
>40
Ttaddty
Category
slightly toxic
practically
non-toxic
practically
non-toxic
slightly toxic
slightly toxic
slightly toxic
slightly toxic
MRID No.
Author/Year
00390017
Smith, 1980
00390019
Summers, 1978
00025224
McCann, 1972
00025223
McCann, 1972
44150201
McCann, 1972
ace. 249455
Yoshida, 1972
ace. 249455
Yoshida, 1972
Study Classification
core
core
core,
(formulated product)
core,
(formulated product)
core,
(formulated product)
supplemental
supplemental
                                 Since the LC50 falls in the range of 40 - 100 ppm, terbacil
                          ranges from slightly to practically non-toxic to freshwater fish on
                          an acute basis.  The guideline (72-1) is fulfilled (MRID 00390017,
                          00390019, 00025223, 00025224, 44150201, acc.#249455).
                                          33

-------
                            (2)    Freshwater Fish, Chronic

                                  A freshwater fish early life-stage test using the TGAI is
                            required for terbacil because the end-use product is very persistent
                            in  the aquatic environment.   There are currently  no data  for
                            assessing chronic effects to freshwater fish. A freshwater fish early
                            life-stage test using the TGAI is outstanding.  The preferred test
                            species is rainbow trout. The guideline is not fulfilled.

                            (3)    Freshwater Invertebrates, Acute
                                                             *
                                  A freshwater aquatic  invertebrate toxicity test using the
                            TGAI is required to establish the toxicity of terbacil to aquatic
                            invertebrates.   The  preferred test species is Daphnia  magna.
                            Results of this test are tabulated in Table 10 below.
Table 10; Freshwater Invertebrate Acute Toxicity
Species (all of testing
below are Static)
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna)
% a.l .
95
not
stated
not
stated
48-fcourECsj
i (ppm) (nominal]
65
68
63
Toxieity Category
slightly toxic
slightly toxic
slightly toxic
MRIDHo,
Author/Year
00390018
McCann, 1981
acc.#249455
Hall, 1981
acc.#125705
Phillips, 1981
Sftt4y
Classification
core
supplemental
supplemental
                                  Since the ECSO falls in the range of 10-100 ppm, terbacil is
                           slightly toxic to aquatic invertebrates on an acute  basis.  The
                           guideline (72-2) is fulfilled (MRID 00390018, accession #249455,
                           accession #125705).

                           (4)    Freshwater Invertebrates, Chronic

                                  A freshwater aquatic invertebrate life-cycle test using the
                           TGAI is required for terbacil since the end-use product is intended
                           for use such that its presence in water is likely to be continuous or
                           recurrent because of the persistence of terbacil. The preferred test
                           species is Daphnia magna.  Currently, there are no data available
                           from this study and it is currently outstanding.  The guideline is not
                           fulfilled.

                           (5)    Estuarine and Marine Fish, Acute

                                  Acute .toxicity testing with estuarine/marine invertebrates
                           using the TGAI is required for terbacil because the end-use product
                                           34

-------
                            is intended for application sites near coastal counties such as apple,
                            forestry, and alfalfa.  The  preferred test species is sheepshead
                            minnow. Results of these tests are tabulated in Table 10 below.
Table 10: Estuarine/Marine Fish Acute Toxicity
Species
Sheepshead minnow
(Cyprinodon variegatus)
iT^ ; ; '- :
%*A.
• 97.4
M-liotir
tCjo (gpm a ju)
108.5 (measured)1
Toxicity
Oategojcy
practically
non-toxic
MKBDNo.
Author/Year ,
41896100
Ward, 1990
Study
Classification
core
 Test was conducted under static conditions.
                                  Terbacil is practically non-toxic to estuarine/marine fish on
                            an acute basis.    The  guideline  (72-3(a)) is fulfilled (MRID
                            41896100).

                            (6)    Estuarine and Marine Fish, Chronic

                                  An estuarine/marine fish early life-stage toxicity test using
                            the TGAI is reserved pending results of the freshwater fish early
                            life-stage toxicity test.

                            (7)    Estuarine and Marine Invertebrates, Acute

                                  Acute toxicity testing  with estuarine/marine invertebrates
                            using the TGAI is required for terbacil because the end-use product
                            is intended for application near coastal counties such as apple,
                            forestry, and alfalfa.  The preferred test species are mysid shrimp
                            and eastern oyster.  Results of these tests are tabulated in Table 10
                            below.
Table10: Estuarine/Marine Invertebrate Acute Toxicity
Species (all tested under
static conditions)
Eastern oyster (embryo-larvae)
(Crassostrea virginica)
Fiddler crab
Grass shrimp
%alf*
84.7
84.7
84,7
Stf-aour LCgd/EC^
(ppma.y (nominal)
>4.9 (48 hr.)
>1000
56.4
Toxicity
Category ,
moderately
toxic
practically
non-toxic
slightly
toxic
MRID No.
Atithor/Year
00012333
Benfley, 1973
00012332
Benfley, 1973
00012332
Benfley, 1973
Study
Classification
core1
supplemental
core
 This study was made core because the ECC was not expected to exceed 4.15 ppm a.i..

                                  Terbacil ranges from moderately toxic to practically non-
                           toxic to estuarine/marine invertebrates on an acute basis.   The
                                           35

-------
       guideline (72-3(b)  and 72-3(c)) is fulfilled  (MRID  00012332,
       00012333).

       (8)     Estuarine and Marine Invertebrate, Chronic

              An estuarine/marine invertebrate life cycle toxicity test using
       the TGAI is reserved pending results from freshwater aquatic
       invertebrate life cycle toxicity test.

c.     Toxicity to Plants

       (1)     Terrestrial

              Terrestrial plant testing (seedling emergence and vegetative
       vigor)  is required because terbacil has  terrestrial non-residential
       outdoor  use patterns and it may move  off the application  site
       through  spray  drift or  runoff.   For seedling  emergence  and
       vegetative vigor testing  the  following plant species and groups
       should be tested: (1) six species of at least four dicotyledonous
      . families, one species of which is soybean (Glytine max), and the
       second of which is a root crop, and (2) four species of at least two
       monocotyledonous families, one of which is corn (Zea mays).

              Terrestrial  Tier II studies are required for  all low dose
       herbicides (those with the maximum use rate of 0.5  Ibs a.i./A or
       less) and  any pesticide showing a negative response equal to or
       greater than 25% in Tier I tests.  Tier n tests measure the response
       of plants, relative to a control,  and five or more test concentrations.
       Results of Tier n toxicity testing on the technical/TEP material are
       tabulated in Table 11 below.
                       36

-------
Table 11: Nontarget Terrestrial Plant Seedling Emergence Toxicitv (Tier ID
Species
Monocot- Corn
Monocot- onion
Monocot- sorghum
Monocot- wheat
Dicot- cucumber
Dicot- pea
Dicot- rape
Dicot- soybean
Dicot- sugar beet
Dicot- tomato
Monocot - wheat
Monocot- corn
Monocot- sorghum
Dicot- sugar beet
Dicot - pea
Dicot- soybean
Dicot- tomato
Dicot- rape
Dicot- cucumber.
&«JU
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
BCjs
(Ib a.i./A>
0.0622
0.0286
0.0913
0.0299
0.0736 '
0.1173
0.0149
0.0963
0.0192
0.0180
0.0250
0.6600 '
0.1100
0.0270
17.0
15.0
0.016
0.013
0.045
EC^ Endpoiat
Affected
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry. weight
dry weight
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
EC^/NOEC
OB*a.iJA>
0.0250
0.0125
0.0500
0.0125
0.0500
0.0286
0.0063
0.0500
0.0125
0.0125
0.0310
0.0310
0.0620
0.0150
0.5000
4.0
0.0070
0.0070
0.0070
BcyNoae
Endpoint Affected
dry weight
dry weight
dry weight
dry weight
dry weight ,
dry weight
dry weight
dry weight
dry weight
dry weight
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
shoot height
MRID,Ne.%
Author/Vear
43895801
Heldrem, 1996
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
McKelvey, 1992
42336701
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
Species was upgraded; to core since EPA now accepts thiram and captan seed treatments in the testing protocol.
Study
Classification
core ,
core
core
core
core
core
core
core
core
core
core
core1
core
core
core1 !
core
core
core
core1

       For Tier n seedling emergence, rape is the most sensitive
dicot (EC25=  0.013 Ib a.i./A).    Wheat is the most sensitive
monocot (EC25= 0.0299 Ib a.i./A).  The guideline (123-l(a)) is
fulfilled (MRID 43895801, 42336701).
               37

-------
Table 12: Nontarget Terrestrial Plant Vegetative Vigor Toxicity (Tier IT)
Species
Monocot- Com
Monocot- onion
Monocot- sorghum
Monocot-Wheat
Dicot- cucumber
Dicot- pea
Dicot- rape
Dicot- soybean
Dicot- sugar beet
Dicot- tomato
Monocot - wheat
Monocot- corn
Monocot- onion
Monocot- sorghum
Dicot- sugar beet
Dicot- cucumber
Dicot- pea
Dicot- soybean
Dicot- tomato
Dicot- rape
%
aX
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
96.9
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
97.4
EC*
0b a.i^A)
0.0297
0.0741
0.0426
0.0087
0.0058
0.0357
0.0048
0.0108
0.0176
0.0126
0.0621
>2.0
0.12
>2.0
0.0008*
0.0022
l.O4
0.0180
0.0110
0.0035
ECu EndpOint
Affected
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight •
dry weight
dry weight
dry weight
shoot height
all parameters
shoot weight
all parameters
root weight
root weight "
shoot weight
shoot weight
root weight
total weight
ECas/KTOEC
a.i./A)
0.0250
0.0500
0.0500
0.0063
0.0031
0.0250
0.0031
0.0018
0.0063
0.0063
0.12
>2.0
0.12
>2.0
<0.00703
0.0070
0.01704
0.0150
0.0070
0.0070
MVNOEC
Ettdpoiat Affected
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
dry weight
shoot height
all parameters
shoot weight
all parameters
root weight
root weight
shoot weight
shoot weight
root weight
total weight
MRIDNo.
Author/Year
43895801
Heldreth, 1996
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
McKelvey, 1992
42336701
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
same as above
Study
Classification

core
core
core
core
core
core
core
core
core
core
core
core
core
core
supplemental
core
core
core
core
core
'The value is not statistically valijd.
'Species were upgraded to core since EPA now accepts thiram and captan seed treatments in the testing protocol.
'The results may not be accurate because they were obtained by extrapolating far outside the range of data.
''Positive rate response.

                                    For Tier n vegetative vigor, cucumber is the most sensitive
                             dicot (EC25=  0.0022  Ib a.i./A).  Wheat is the most sensitive
                             monocot (EC^ 0.0087 Ib a.i./A).  The guideline (123-l(b)) is
                             fulfilled (MRID 43895801,42336701).

                             (2)     Aquatic

                                    Aquatic plant testing (tier IT) is  required for terbacil because
                             it move off-site by runoff and by aerial spray drift.  The following
                             species should be tested  at Tier II:   Kirchneria subcapitata
                             (Selenastrum capricomutum), Lemna gibba, Skeletonema costatum,
                             Anabaenaflos-aquae, and a freshwater diatom. Results of Tier n
                             toxicity testing on the technical/TEP material are tabulated in Tale
                             13 below.
                                              38

-------
Table 13; Nontarget Aquatic Plant Toxicity (Tier D)
Species
%a.i.
EC*,
(ppma.i.)
•JSCWNOKC
(ppma.i.)
MSBEDN0W
Author/Year
Study
Classification
Vascular Plants
Duckweed Lemna gibba
96.44
0.140
0.065
43929801 Thompson, 1996
core
NEonvascBlar Plants ( , ,
Green algae
Kirchneria subcapitata
Marine diatom
Skeletonema costatum
Freshwater diatom
Navicula pellieulosa
Blue-green algae
Anabaena flos-aquae
97.4
96.44
96.9
96.44
0.018
0.140
0.011
0.120
v 0.004 '
0.081
0.007
0.06:2
42306101
Hoberg, 1990
43929802
Thompson, 1996
43909802
Hughes, 1996
43929802
Thompson, 1996
core
core
core
core
                                 The Tier n results indicate that Navicula pellieulosa is the
                          most sensitive nonyascular aquatic plant.  The guideline (123-2) is
                          fulfilled (MRID 43929802, 43909802, 42306101, 43929801).

             2.     Environmental Fate
                                                                                     i

                    All environmental fate data are fulfilled at this time.  However, additional
             information on aerobic aquatic metabolism (162-4) of terbacil is needed because
             terbacil is likely to move into surface waters. These data will provide, a more
             realistic assessment of terbacil concentration in surface waters.

                    a.     Environmental Fate Assessment

                          Based on acceptable, supplemental, and ancillary environmental fate
                    data, terbacil dissipation appears to dependent on  microbial-mediated
                  .degradation, photodegradation in water, and movement into ground and
                    surface waters.   The relative importance of degradation and mobility in
                    controlling terbacil dissipation under actual use conditions cannot be fully
                    evaluated from the existing environmental fate data.   However, the data
                    indicate that terbacil ,is  very, persistent and potentially very mobile in
                    terrestrial environments.   Compounds with similar  environmental fate
                    behavior (e.g., bromacil) have been detected in ground and surface waters.

                          Terbacil is stable to abiotic hydrolysis and slowly degrades through
                    photolysis in natural and reference laboratory water samples (im= 29 to 54
                    days) and soil (t1/2=122 days).  The photodegradation rate appears to be
                    dramatically enhanced by the presence of some photosensitizers (riboflavin
                                         39

-------
 and methylene blue).  Major photodegradation transformation products
 (>10%  of   applied)   are  . 5-chloro-6-methyluracil,   3-tert-butyl-6-
 methyluracil, and 6-chloro-2,3-dihydro-3,3, 7-trimethyl-5H oxazolo (3,2-
 a)-pyrimidine-5-one, tert-butyl-5-acetyl-5-hydroxyhydantoin (Compound
 IT),  3-tert-butyl-5-hydroxyhydantoin  (Compound HI),  and 5-chloro-6-
 methyl-(3l,5t)-5I-chloro-6l-methyl-5',6'-dihydro-6',2-anhydro-3t-tert-
 butyluracilyluracil (Compound VI).  Terbacil is persistent under aerobic
 and anaerobic soil conditions (t1/2= 235 to 653 days). Minor nonvolatile
 transformation  products  are  t-butylurea   and  3-t-butyl-5-chloro-6-
 hydroxymethyuracil.  The major volatile transformation product is CO2.
 The reported laboratory degradation data indicate terbacil is persistent in
 terrestrial environments.

       Terbacil has a low sorption affinity to  soil (1^=0.39 to 1.3 ml/g;
 Koc=  44 to 61 ml/g). Therefore, terbacil is expected to be very mobile in
 soil.  Soil column studies also indicate that terbacil and its transformation
 products can move through soil columns. Laboratory mobility  studies
 indicate terbacil and its transformation products are potentially mobile in
 terrestrial environments.

       Marginally acceptable field dissipation studies indicate terbacil, at
 5 Ibs a.i./A, is persistent and mobile under actual use conditions.  Field
 dissipation half-lives in Delaware, Illinois, and  California ranged from 204
 to 252 days.  The maximum depth of terbacil detection was 45 to 50 cm .
 Ancillary field studies using plants as biological indicators also suggest'that
 phytotoxic "terbacil residues" are persistent and mobile.  Field dissipation
 studies  confirm that terbacil is  persistent and potentially mobile  under
 actual use conditions.

       Terbacil was bioaccumulated (< 8 jtig/g) in bluegill sunfish tissues
 under static concentrations of  0.01 and  1.00>g/ml.  Bioaccumulated
 terbacil declined below the detection limit (<0.01 ^g/g) during a 3 day
depuration period.   Terbacil is not expected to bioaccumulate in fish
tissues.

b.    Environmental Fate and! Transport

       (1)    Degradation

             (a)    Abiotic Hydrolysis

                    Radiolabeled terbacil was stable (>  6 weeks) in pH
             5, 7,  and 9 buffer solutions in the dark at 25°C (Ace. No.
             0001946).   Ancillary data also indicate terbacil was stable
                      40

-------
 in pH 4 to 10 buffer solutions at 25°C (Archer et d., 1981).
 The hydrolysis (161-1) data requirement is fulfilled.  No
 additional hydrolysis data are needed at this time.

 (b)     Photodegradation in Water

        Radiolabeled terbacil, under natural sunlight, had a
 first-order photodegradation half-life of 29 days in standard
 reference water, 37 days in Brandywine River Water, 54
 days in  the  Brandywine River  Water  with suspended
 sediment, and 3.25 days in reference water with a riboflavin
 sensitizer (Rhodes, 1975).  Under UV light from fluorescent
 and black lights, radiplabeled terbacil had a first-order
 photodegradation half-life of 44 days in standard reference
 water, 82.91 days  in Brandywine River Water, and 4.8
 days in reference water with a riboflavin sensitizer.  Major
 photodegradation products  (>10% of applied were 5-
 chloro-6-methyluracil, 3-tert-butyl-6-methyluracil, and 6-
 chloro-2,3-dihydro-3,3,7-trimethyl-5H  oxazolo  (3,2-a)-
 pyrimidine-5-one.  Radiolabeled terbacil, at  700 pg/ml,
 under natural sunlight,had a first-order photodegradation
 half-life of <  2 hours in non-buffered aqueous solutions (pH
 3.4  to 9.2)  containing  methylene blue  (3  /tg/ml) or
 riboflavin (10  /ig/ml) photosensitizer  (Archer,  1981).
 Terbacil,  at  250 ppm,  was photolytically stable in non-
 buffered  aqueous solutions  (pH  4-10)  irradiated  with a
 mercury  (Hg) vapor lamp at 25 °C.   Rose  bengal and
 methylene blue were effective sensitizers in near- neutral to
 alkaline non-buffered  aqueous solution (pH  >   6.6).
 Riboflavin, at 10 /tg/ml,  was an effective photosensitizer in
 non buffered  aqueous  solutions (pH 4"to 10). Humic acid,
 however,  was  not  an effective  sensitizer in aqueous
 solutions.  Major photodegradation  products  (>10% of
 applied)  were  3-tert-butyl-5-acetyl-5-hydroxyhydantoin
 (Compound     S),     3-tertrbutyl-5-hydroxyhydantoin
 (Compound ID),  and 5-cUoTo-6-m&±yl-(3',5")-5'-ctiioTO-6'-
 methyl-5', 6' -dihydro-6', 2-anhydro-3' -tert-butyluracil
 (Compound VT).   Also, an unidentified  photoproduct
 (Compound V) was precipitated during photodegradation of
 terbacil. Compound m, 3-tert-butyl-5-hydroxyhydantoin,
 does  not  appear to be  a  photodegradate  because  it was
 detected in dark  controls.  The Photodegradation in Water
 (161-2) data  requirement is  fulfilled.   No  additional
photolysis in water data are needed at this time.
         41

-------
(c)    Photodegradation on Soil

       Radiolabeled  terbacil  at  1.2  Ibs/A  had  an
extrapolated first-order degradation half-life of 61 days on
a Drummer silty clay loam when continuously irradiated for
15 days with a xenon arc lamp at 25°C (Accession No.
00160235). A corrected photodegradation half-life, based
on a 12 hour photoperiod, would theoretically be 122 days.
Radiolabeled terbacil was stable in the dark controls.  The
degradation   product,   5-chloro-6-methyluracil,    was
detectable in both irradiated and  dark control treatments.
However,  unidentified radioactivity was detected in the
methanol soil  extracts and non-extractable  soil organic
matter.

       In an ancillary study,  radiolabeled terbacil had a
first-order degradation half-life  of 46 days on a Keyport silt
loam  when   continuously  irradiated  with  fluorescent
sunlamps and  black light (1500 ptW/cm2) for 8 weeks
(Rhodes, 1975).  Dark controls were not used in this study.
The major degradate (> 10%  of applied) was 5-chloro-6-
methyluracil.        •

       The  Photodegradation  on   Soil  (161-3)  data
requirement is fulfilled.  No additional photodegradation on
soil data are needed at this time.

(d)    Photodegradation in Air

       The  Photodegradation  in   Air  (161-4)  data
requirement is waived because terbacil  has a low vapor
pressure (4.7 x 10"7 mm Hg at 29.5°C)  and low Henry's
Constant (1.9 X 10'9 atm. nrVmole).  The Photodegradation
in Air (161-4) data requirement is waived.
(e)
Aerobic Soil Metabolism
       Radiolabeled  terbacil,  at 9.3  fig  /g,  had  an
extrapolated, first-order half-life of 653 days in a Sassafras
sandy loam soil when incubated for 12 months at 25° C in
the dark (MRID 42369901).  The major transformation
product  (>   10%  of  applied)  was  14C02.    Minor
transformation products (<  10% of  applied)  were t-
butylurea and 3-tert-butyl-6-methyluracil.  In an ancillary
study, radiolabeled terbacil had a half-life of 2 to 3 months
         42

-------
 in nonsterile soils (Fallsington sandy loam and Flanagan silt
 loam)  when incubated in a greenhouse (Rhodes,  1981).
 Unacceptable  aerobic  soil  metabolism  data indicate
 radiolabeled terbacil, at 4 jig a.i./g, had an extrapolated,
 first-order half-life of 520 days in non-sterile silty clay: loam
 soil when incubated for one year in the dark at 25°C (MRID
 40253601).  In sterile soil, terbacil had an extrapolated half-
 life of 1007 days.  Non-volatile, transformation products
 were not identified; 14CO2 accounted for 9.7% of applied
 terbacil.

        Terbacil  (Sinbar  80 WP),  at 100  /tg/g, had an
 estimated first-order half-life of 720 days in Triangle and
 Boddington  sandy loam soils (05013201; Marsh and Davis,
 1978). Radiolabeled terbacil, at 4.5 Ibs  a.i./A, had an
 estimated first-order half-life of 32.5 days when incubated
 in Keyport silt loam soil irradiated with 12 hoiir per day
 photoperiod of UV light  (mercury vapor light) for 6.5
.weeks  (Rhodes, et al. 1969).  The major degradate was
 14CO2  (32% of applied  radioactivity).    Radiolabeled
 terbacil, at 2.8 /*g/g, degraded to form 14CO2 (28 to 38% of
 applied) in a Greenfield  sandy loam soil unamended or
 amended with plant residues with different carbon : nitrogen
 ratios when incubated at 60% of field capacity at 22°C
 (05024336,  Wolf, D.A.  Ph.D.  dissertation; 05013204;
 05016176, Wolf and Martin, 1974).

       The  Aerobic  Soil  Metabolism  (162-1)  data
 requirement is fulfilled.   No  additional aerobic  soil
 metabolism  data are needed at this time.

 (f)    Anaerobic Soil Metabolism

       Radiolabeled  terbacil,- at  9.3  jig/g,   had  an
extrapolated,  first-order  half-life  of 235  days  when
incubated for 90 days in anaerobic Sassafras sandy loam soil
at  25°C  in   the  dark  (MRID  42370001).    Minor
transformation  products  (<10%  of applied)  were t-
butylurea and 3-tert-butyl-5-chloro-6-hydroxymethyluracil.

       In  an ancillary study, radiolabeled terbacil, at 2.1
jttg/g, had a half-life of > 60 days when incubated for 60
days in anaerobic mineral soils (Fallsington and Flanagan)
under  greenhouse  conditions (Rhodes,  1981).   In an
         43

-------
(2)
       unacceptable study, radiolabeled terbacil, at 4 /*g/g, had an
       extrapolated, first-order  half-life  of 178 days  when
       incubated in anaerobic silty clay loam soil in the dark at
       25°C  (MRID  40104701).    Under  sterile  conditions,
       radiolabeled  terbacil was stable  (t1/2    >  60 days).
       Radiolabeled terbacil, at 2.8 /ig/g, did not degrade to form
       14CO2 ( 0.2 %  of applied) in Greenfield sandy loam soil
       unamended or amended with plant residues with different
       carbon: nitrogen  ratios when' incubated  under  flooded
       conditions  at  22°C  (05024336,  Wolf,   D.A.  Ph.D.
       dissertation; 05013204, Wolf, D.C., 1974.; 05016176,
       Wolf and Martin, 1974). Terbacil (unspecified formulation),
       at 8 /tg/g, degraded with a half-lives of 5 and 8 months in
       a Chehalis loam soil  at  31 °C  and  13°C, respectively
       (Zimdahl et al., 1970). Terbacil degradation was dependent
       on first-order degradation kinetics.
             The  Anaerobic
       requirement is fulfilled.
       this time.
                        Soil  Metabolism  (162-1)  data
                        No additional data are needed at
(g)    Aerobic Aquatic Metabolism

       Although the aerobic aquatic metabolism data are not
needed to support terrestrial uses of terbacil, environmental
fate properties of terbacil are similar  to   compounds
commonly detected in surface waters.  Therefore, terbacil
is expected to move into surface waters from terrestrial use
sites.  Aerobic aquatic metabolism data are needed to define
the rates  and  routes of  terbacil dissipation  in  aquatic
environments.  These data will be used to provide more
refined estimated environmental concentrations of terbacil
in surface water.

Mobility

(a)    Batch equilibrium/soil column leaching

       Radiolabeled terbacil, at 0.27 to 6.28 /tg/ml, had a
Freundlich adsorption coefficient of 0.39 ml/g (1^=61
ml/g; l/n=0.78)  in Woodstown  sandy loam,  0.71 ml/g
0^=58 ml/g;  l/n=0.82) in Cecil sandy loam; 1.3 ml/g
(^=52  ml/g;  l/n=0.90),   1.2  ml/g  Q£ =44  ml/g;
l/n=0.97)  in  a  Keyport silt  loam  (Accession  No.
               44

-------
 00155104).   The  Freundlich desorption coefficient  for
 terbacil were  0.67 ml/g  (Kx=6l ml/g;  l/n=0.45)  in
 Woodstown sandy  loam,  1.5  ml/g  (Koc=71  ml/g;
 l/n=0.35) in Cecil sandy loam;  2.6 ml/g (K^.^104 ml/g;
 l/n=0.26), and 2.5 ml/g ^=92 ml/g; l/n=0.26) in a
 Keyport silt loam.   Radiolabeled terbacil had Freundlich
 adsorption coefficient of 2.46 ml/g (Koc=63.6 ml/g) in a
 Webster silty clay loam,, 0.38 ml/g 1^=42.2 ml/g) in a
 Cecil sandy loam, 0.38 ml/g (K^.-76 ml/g) in a Glendale
 sandy clay loam, and 0.12 ml/g  (8^=21.4) in Eustis fine
 sand (05014424, Davidison etal.,  1978;05008371, Rao and
 Davidison, 1979). Radiolabeled  terbacil, at 1 /eg/ml, had
 Freundlich adsorption coefficients ranging from 0.72 ml/g
 0^=57.6 ml/g; l/n=0.73) to 1.65 ml/g (1^=84.6 ml/g;
 l/n=0.97) for  twelve mineral soils (05014175, Liu et al.,
 1971).   Terbacil had  a  soil TLC  Rf of  0.54  for a
 Woodstown sandy loam, 0.36 for  a Cecil sandy loam, 0.28
 for a Flanagan  silt loam, and 0.27 for Keyport silt loam.

       Terbacil and its minor transformation products' were
 leached through 30 cm columns of Flanagan silt loam and
 Sassafras sandy loam soil when  eluted with 20 inches of
 0.01  M   CaClj   (MRID  42335401).    Terbacil was
 predominately  detected  in  leachate  samples.   Minor
 transformation products (9 to 11%  of applied terbacil) in the
 leachate  samples   were  t-butylurea,   and   3-t-butyl-6-
 methyluracil and 6-chloro-2,3-dihydro-7 (hydroxymethyl)-
 3,3-dimethyl-5H-oxazolo(3,2-a)pyrimidin-5-one.   In  an
 ancillary study, Radiolabeled terbacil,  at 2  Ibs/A, was
 leached (4 to 64% of applied radioactivity) through 18 inch
 packed soil columns of Fallsington  sandy loam and Flanagan
 silt loam when eluted with 20 inches of water (Rhodes,
 1981). Also, "unidentified" terbacil residues were leached
 (4 to 52% of applied radioactivity) through packed soil
 columns of Fallsington sandy loam and Flanagan silt loam.
 Radiolabeled terbacil (73, to 90%  of applied radioactivity)
 was  leached through 30  cm columns of surface and
 subsurface Wabasso fine sand when eluted with 15.5-to-20
 inches of  0.01 M  CaSO4.   Based on  plant bioassays,
phytotoxic terbacil residues were eluted with 10 to 20 cm of
water to a depth of 27.5 to 30 cm in  packed  30 cm soil
columns of Fox sandy orchard soil  (05013202, Marriage  et
al. 1977).
         45

-------
              The Batch Equilibrium/Soil Column Leaching (163-
       1) data requirement is fulfilled.  No additional mobility data
       are needed at this time.

       (b)    Laboratory Volatility

              The Laboratory Volatility (163-2) data requirement
       is waived because terbacil has a low vapor pressure (4.7 x
       10"7 mm Hg at 29.5°C) and low Henry's Constant (1.9 X
       10-9 atm m3/mol).

(3)    Accumulation

       (a)    Fish

              Radiolabeled terbacil, at 0.01  and 1.00 fig/ml, was
       accumulated, respectively, at concentrations of 0.11 and 7.9
            in viscera,  0.02 and 1.8 /tg/g in head, 0.07 and 4.4
            in the livers, and 0.02 and 1.7 /tg/g in edible tissues of
       bluegill sunfish over 4 week exposure period (Accession
       No.  00011947).    Terbacil residues in all  fish  tissues
       declined below the detection limit (<0.01 /ng/g) during a 3
       day depuration period.  Terbacil was the only radioactive
       residue identified in fish tissues. The Bioaccumulation in
       Fish (165-4) data requirement is fulfilled.  No additional
       data are needed at this time.

(4)    Field Dissipation

       Terbacil (Sinbar 80% wettable powder), spray or broadcast
applied at 5 Ibs a.i./A, had a first order half-life of 212 days on silt
loam soil in Delaware, 204 days on a silty clay soil in Illinois,  and
252 days on a sandy  loam soil in California (MRID 43585500).
Terbacil "residues" were detected (< 0.09 jtg/g) at a maximum soil
depth of 45 to 50 cm.  In California and Delaware field studies, the
terbacil    transformation    product,     3-t-butyl-5-chloro-6-
hydroxymethyluracil,  had a maximum concentration of 0.14 /*g/g
at  15  days  and  then  declined to  <  0.8  /tg/g  at  60 days
posttreatment.   The transformation product, 6-chloro-2,3-dihydro-
7-(hydroxymethyl)-3,3-dimethyl-5H-oxazolo[3,2-a]pyrimidin-5-
one, had a maximum  concentration  of 0.07  jtg/g at  60 days
posttreatment in the California study;
                46

-------
        In a  supplemental  microplot  field  dissipation  study,
 radiolabeled terbacil at 2 Ibs a.i./A had a half-life of 1 to 2 months
 when incubated in the field for 4 months with a cumulative rainfall
 of 18.33 inches (Rhodes, 1981).  Terbacil .was detected in the 12 to
 15 inch soil segment. In an unacceptable long-term field dissipation
 study, terbacil (Sinbar 80% wettable powder), applied at 1.0, 2.0,
 and 4.0 Ibs/A/year for 16 consecutive years, did not appear to
 accumulate on a study site in Delaware.  Terbacil was detected (<
 l>g/g) in the surface 12 inches of soil in the 2,0 and 4.0 Ibs a.i./A
 treatments.  The transformation product, [6-Clair-2,3-dihydro-3,3-
 dime%l-7-hydroxymelyl-5H-oxazolo(3,2-)pyrimidine-5-one], was
 detected at maximum concentration of 0.06 ^g/g.  Radiolabeled
 terbacil, at 4 Ibs a.i./A, had an estimated first-order half-life of 131
 days when incubated for 52 weeks in microplot field studies (4 inch
 diameter x 12 inch depth in situ lysimeter) in a Butlertown silt loam
 (Gardiner,  et al.  1969)  Radiolabeled  residues were detected
 throughout the lysimeter at 5 weeks posttreatment. The study Site
 location and climatic conditions were not reported.

        Several  field dissipation  studies  for  terbacil have been
 reported  using  chemical  non-specific bioassay  techniques  for
 detection of "terbacil residues".  Although chemical non-specific
 bioassays are not accepted as a reliable analytical technique, the
 Agency believes that field dissipation studies using chemical non-
 specific bioassays  provide  ancillary  qualitative data  on  the
 dissipation of "terbacil residues".  Such data, however, cannot be
 used to  fulfill the terrestrial  field  dissipation (164-1)   data
 requirement.
'.                      • .                    "       "        . v
       Terbacil  applied at 1.6 Ibs a.i./A in a Washington orchard
 soil  was  detected  1 year posttreatment  using oats, beans,  and
 cucumbers as phytotoxicity indicators (05020698;  Benson,  1973).
 Phytotoxic terbacil residues were detected at a maximum depth of
 18 to 24 inches. No rainfall data  were reported.  Terbacil, 2.24
 kg/ha/year for 4 consecutive years,  caused phytotoxic effects on
 oats and beans at two years posttreatment on an acidic Camas clay
 loam soil (05013351;  Doughty,  1978).   In contrast, phytotoxic
 terbacil residues (< 0.03>g/g) were not detected on a high organic
 matter, acidic, Mossy Rock silt loam amended with terbacil at 4.48
kg/ha for 4 consecutive years.  Phytotoxic residues from terbacil
 (unspecified source), at 2  to 16 Ibs/A,  were detected 13 months
posttreatment in surface  soil of Mabi clay soil planted with sugar
cane in Puerto Rico (00017711; Liu, L.C. et al. 1977). Phytotoxic
residues from terbacil (unspecified source), as a banded application
                47

-------
c.
at 1.2 and 2.4 lbs/A, were detected at 7 months posttreatment on
clay  loam  soil in California  (00028135,  Isom, et al.,  1969;
05019594, Isom, et al., 1970). Terbacil (unspecified formulation),
applied on the soil surface or incorporated at rates 2.24 and 4.48
kg/ha for three consecutive years, degraded with an estimated half-
life of 157 days  on peach orchard sandy soil (sites unspecified)
(05013212, Skroch et al., 1971). Terbacil was detected (< 0.07
Atg/g) at a maximum soil depth of 15 to 30 cm soil following the
second and third year applications.

       Terbacil applied at 4.5 kg/ha/year over three applications
was detected (<  100 /tg/L; 0.5 to 1.8% of terbacil) in subsurface
waters at 107 cm in "lysimeters" on a field plot with a Oldsmar
sand  in Florida citrus orchard  (05017062, Mansell et al.,  1979;
05014421, Mansell et al., 1977)

       The Terrestrial Field Dissipation (164-1) data requirement
is fulfilled.  No additional data are needed at this time.

(5)    Spray Drift

       No terbacil spray drift-specific studies were reviewed.
Droplet size spectrum (201-i)  and drift field evaluation (202-1)
studies were required since the different products may be applied by
aircraft and orchard airblast and due  to the concern for potential
risk to flontarget aquatic  organisms.   However, to satisfy these
requirements the registrant in conjunction with other registrants of
other pesticide active  ingredients formed the Spray Drift Task
Force. (SDTF).   The SDTF has completed and submitted to the
Agency its series of studies which are intended to characterize spray
droplet drift potential due to various factors* including application
methods,  application equipment, meteorological conditions, crop
geometry, and droplet  characteristics.   Until  these  data  are
evaluated, the Agency is relying on previously submitted spray drift
data and the open literature for off-target, drift rates.  The rates are
1% of the applied spray volume from ground applications and 5%
from aerial and orchard airblast applications at 100 feet downwind.
After its  review  of the new studies  the Agency will determine
whether a reassessment is warranted of the potential risks from the
application of terbacil to nontarget organisms.

Water Resources
       Terbacil is currently regulated under the Safe Drinking Water Act
(SDWA).   EPA's  Office of Water  has not established  a Maximum
                      48

-------
Contaminant Level (MCL) however it has set Health Advisories (HA's) for
terbacil residues in drinking water. The reference dose (RfD) for a 70-kg
adult was established at 0.013 mg/kg/day.  The one day,  ten day and
"longer-term" HA for a 10-kg child is 300 jtg/1.  The "longer-term" HA
for a 70-kg adult is 900 jig/1, and the Lifetime HA has been set at 90 us/1
(US EPA, 1996).

       (1)    Ground Water

             Terbacil has the characteristics  of compounds  known to
       leach  to ground  water.   (See Environmental Fate Assessment.)
       Based on the environmental fate data, terbacil exceeds the mobility
       and  persistence   triggers for  the .proposed  Restricted  Use
       Classification for ground water concerns.  Currently, there are an
       insufficient number of terbacil  detections  in ground water  to
       warrant a Restricted Use classification.  However, future expansion
       of the  terbacil use areas is expected to increase the potential for
       terbacil to  move into  ground water.

             (a)    Leaching Potential

                   There are no ground-water monitoring studies which
             allow an evaluation of the leaching potential of terbacil into
             ground  water.  The environmental fate data indicate that
             terbacil may leach -into ground water because of terbacil's
             persistence and potential mobility.  Barrett (1995) concluded
             from a generic screen of leaching potential that terbacil has
             a greater leaching potential than other herbicides commonly
             detected in ground water at numerous locations.
Table 14: Leaching potential of terbacil compared with some maior use herbicides
Compound
terbacil
GUS Scores
6.38 , .
Major uses
mint, apples, alfalfa
GW Concerns
Compound
terbacil
GUS Scores
6.38
GUS Scores
6.38
Maior uses
mint, apples,
GW Concerns
Compound
terbacil
GUS Scores
6.38
Major uses
mint, apples,
Major uses
mint, apples, alfalfa
GW Concerns
Compound
terbacil
GUS Scores
6.38
Major uses
mint, apples, alfalfa
GW Concerns
Compound
GW Concerns
Compound 	
terbacil ,
GUS Scores
6.38
Maior uses
mint, apples,
GW Concerns
Compound
terbacil
GUS Scores
                     49

-------
                                        A Groundwater Ubiquity Score  (GUS) score above
                                  2.8 indicates relatively high leaching potential; a score
                                  above 1.8 indicates moderate leaching potential. Median or
                                  typical Koc and half-lives were selected to calculate GUS
                                  scores.  Herbicides in the upper half of this list have been
                                  detected  in  numerous  ground-water  samples  with  the
                                  exception of newer, ultra-low rate compounds for  which
                                  little monitoring of any kind has been completed to date.
                                  "Yes" indicates a ground-water study has been required to
                                  support  registration, environmental fate and field studies
                                  have shown high leaching potential, or there is evidence of
                                  relatively widespread contamination of ground water from
                                  past use;  "marginal"   indicates  that some concerns  for
                                  leaching  to ground water have been raised in registration or
                                  reregistration but no study to support registration has been
                                  conducted; "no"  indicates that concerns  for leaching to
                                  ground water have not been identified.

Table 15; Leaching potential of terbacU compared with herbicides with similar use patterns
.Compound
terbacil
terbacil (best case)
hexazinone
metribuzin
simazine
ametiyn
asulam
diuron
2,4-D
pendimethalin
bromoxynil
trifluralin
GUS Scores
6.38
5.32
5.29
4.48
3.77
3.41
2.84
2.73
2.70
0.66
0.25
0.19
"Uses ' - ,
alfalfa, apples, mint, sugarcane
alfalfa, apples, mint, sugarcane
alfalfa, sugarcane
alfalfa, sugarcane
alfalfa, apples
sugarcane
sugarcane
alfalfa, sugarcane, apples
alfalfa, apples, sugarcane
mint, sugarcane
alfalfa, mint
alfalfa, mint, sugarcane
                                  (b)    Ground Water Monitoring Data

                                        Based on information from the "Pesticides in Ground
                                  Water Database", terbacil has not been detected frequently
                                  in ground water (Hoheisel  et al., 1992). The monitoring
                                  data indicate that terbacil was detected in six wells from a
                                  total 288 wells across six states.  Terbacil was detected in a
                                  well in Oregon at a concentration of 8.9 jtg/L and five wells
                                  in West Virginia at a concentration range of 0.3 to 1.2
                                  lig/L.
                                          50

-------
        The lack of detections of terbacil in ground water
  may be associated with the limited geographical extent of
  the terbacil use area as well as the  relatively low total
  environmental  loading compared  to other herbicides.
  Additionally,  ground  water monitoring  data  has been
  reported for areas with no terbacil use.  For example,  the
  single largest groundwater monitoring program, as reported
  in the  "Pesticides in  Ground Water Database", was
  conducted in  Mississippi.    Forty-one  percent  of  the
  monitoring  data , were taken from wells  in Mississippi,
  However, terbacil usage data indicate that terbacil is  not
  used in Mississippi (DuPont and Resources for the Future)
  data. Also, the estimated annual use of terbacil, in terms of
 pounds of active Ingredient, is one tenth to one  hundredth
  of the annual  use  of herbicides commonly detected in
 ground  water  such  as atrazine, alachlor, metolachlor,
 cyanazine, dicamba, metribuzin, and simazine.  Another
 possible reason for the low frequency of detections  of
 terbacil in  some ground-water monitoring surveys are high
 limits of detection for terbacil.  In most of the state surveys,
 the limits of detection for terbacil has been 5 to 100 times
 higher (i.e., less sensitive) than the limits of detection for
 widely used herbicides. Barrett (1995)  reported that limits
 of detection for  terbacil  from  the Mississippi and
 Washington monitoring programs ranged from 3.5 to 4 6
 (c)    Comparative Leaching Assessment

       The PATRIOT model was used to  perform a
 comparative leaching assessment of terbacil relative to a
 conservative   tracer,  and  other  common   herbicides.
 PATRIOT is a program to run Pesticide Root Zone Model
 -  2 (PRZM).   PRZM is a one-dimensional, dynamic,
 compartmental model that can be used to simulate pesticide
 movement in  unsaturated  soil   systems  within  and
 immediately below the plant root zone.  '

       PATRIOT modeling for terbacil was conducted on
 representative  soils for apple production in New York and
 Oregon,  peaches in Georgia and sugarcane in  Louisiana.
 The leaching of terbacil was then compared to the potential
 leaching  of atrazine and bromide.  Atrazine was selected
because it is a well characterized corn herbicide and is
         51

-------
known to leach to ground water.  Bromide was selected
because it is an anibn in aqueous environments, resists
binding, will move with the water front and is often used as
a tracer for ground water research and studies. Additional
assumptions and input from the PATRIOT modeling  are
appended to the end of this document.

       Hydrologic Group C soils were used for modeling of
apple production hi New York and Oregon. These soils  are
less prone to leaching and have a much higher potential  for
surface water runoff.  PATRIOT  modeling  predicted that
approximately 40%  of the terbacil mass applied could leach
to shallow ground  water (4.5 feet) on the apple use sites.
Comparative modeling on the  same soils predicted that
< 1% of atrazine could leach, while 70-87% of bromide
could leach.

       Georgia peach production areas were modeled using
Hydrologic Group D soils which have the least potential  for
leaching. PATRIOT modeling predicted that approximately
51% of the applied terbacil could  leach to shallow ground
water.   In comparison, 18%  of atrazine could leach, and
59% of bromide could leach.

       Ten Louisiana sugarcane  soils  were selected  for
modeling   with PATRIOT.    The PATRIOT  database
indicates  that the  Commerce  (Aerie Fluvaquent)  and
Patoutville (Aerie  Orchraqualf) soils account the largest
acreage of sugarcane in Louisiana.   These  soils  are
classified  as Hydrologic Group C and  were predicted to
have a moderate potential to leach. PATRIOT predicted
that 47-51% of the applied terbacil would leach to shallow
ground water.  Several of the lower acreage  Group D soils
had the highest leaching potential with 64-75% of  the
terbacil mass predicted to leach.  These soils only represent
a small portion of the Louisiana sugarcane production area.

       Not unexpectedly, leaching is related to the amount
of precipitation received.  Thus the estimates of the annual
leaching of terbacil on Group B, C, and D soils is strongly
Controlled by  the rainfall, which  can be highly variable.
Calculations  are presented  as  ten year mean  values to
account for variability in precipitation.  Since terbacil is
persistent in soil, terbacil will probably accumulate in  the
         52

-------
                                soil and thus the total mass reaching ground water in a
                                particular year may exceed the total mass applied in a given
                                year.   The mass of terbacil estimated to leach to ground
                                water for each year ranged from approximately 0 to 125%
                                of the annual application.

                                       PATRIOT modeling was not conducted on Group A
                                soils  because  Group  A soils  do  not  appear  to  be
                                representative of the terbacil use areas. In addition, no
                                modeling was conducted for mint or alfalfa production
                                because of incomplete usage and soils data.
Figure 1 - Predicted Leaching Using PATRIOT Model (Sugarcane)
                            Terbacil Use on Sugarcane
                      Predicted Leaching  using PATRIOT model
              100
T3
CD
-§  80
(0

            "O
            J2  60
            Q.
            O.
            o  40

            CD  '
            2
            
-------
Figure 2 - Predicted Leaching Using PATRIOT Model (Apples and Peaches)
                                     Terbacil
                      Predicted Leaching using PATRIOT model
                                            liioo
                 New York Aooles
              Hydrologic Group C Soils
           Terbacil
Atrazine
Bromide
                        2  80
                        TD
                        
-------
        water concentrations from ground water monitoring studies,
        environmental fate properties (aerobic soil half-lives and
        organic   carbon  partitioning   coefficients-Kocs)  and
        application rates.

               Results from the SCI-GRO screening model show
        that the maximum  chronic  concentration of  terbacil  in
        shallow groundwater is not expected to exceed 125 /tg/L for
        me majority of the use sites. Uncertainties in,the SCI-GRO
        are: 1) The screening model does not consider site specific
        factors  regarding hydrology,  soil properties,  climatic
        conditions, and agronomic practices;  2)  The  screening
        model does not account for volatilization; and 3) Predicted
        ground water concentrations are linearly extrapolated from
   .-     the application  rates.   Drinking water standards for human
        health  are 1.) the childrens HA is 300 /tg/1 (ppb), 2.)the
        adult  "longer  term"  HA is  900 ppb,  and 3.)  the adult
        lifetime HA is 90 ppb.

              Although groundwater screening models indicate
        terbacil could potentially contaminate shallow ground water
        near specific use sites, there is  a small chance terbacil
        concentrations   in  groundwater  would exceed  EPA's
        drinking  water standards  from  the current  terbacil use
        patterns.  This assessment is based on the fact that terbacil
        is used in limited use areas on minor crops coupled with
        relatively low  environmental loading.   Expanded use of
        terbacil, especially on major crops,  may trigger the need for
        a small-scale prospective ground  water study and surface
        water monitoring.

 (2)     Surface Water

        Since terbacil is applied as an aerial and ground spray, there
is potential for direct spray drift deposition into surface waters
adjoining target use sites. The drift potential for aerial and ground
spray is assumed to be equivalent to 5% of applied and 1% of
applied, respectively. Terbacil is very persistent (t1/2 =  653 days)
and potentially mobile (K^ = 54 ml/g)  in terrestrial environments.
The major routes of terbacil dissipation appear to be dependent on
microbial-mediated degradation and movement into ground and
surface waters. Volatilization is not expected to be a major route
of dissipation for terbacil because it has a low vapor pressure (4.80
x 10-7 Torr) and low Henry's Constant (1.90 X 10'10 atm*m3/mole)
for terbacil. The reported environmental fate data suggest terbacil
can be dissolved in runoff waters.
                55

-------
                                 Once in surface water, the dissipation of dissolved terbacil
                           appears   to  be   dependent   on  photodegradation.      The
                           photodegradation   half-life  for    terbacil     is   29  days.
                           Photodegradation of terbacil is enhanced in the presence of some
                           photosensitzers.  Photodegradation is expected to be a predominant
                           dissipation pathway in clear, shallow waters with long hydrologic
                           residence times. Terbacil is not expected to be found in bottom
                           sediments because  it exhibits  low soil/sediment sorption affinity
                           (average. K,,,. = 54 ml/g).  No data are available to assess the
                           persistence of terbacil in aquatic environments.

                                 The following data (Table 15) were used for input into the
                           GENEEC and PRZM-EXAMS modeling for terbacil:
Table 15: Data Used for GENEEC and PRZM- EXAMS Modeling
Parameter
soilK^
Aerobic soil half-life
Aerobic aquatic half-life
Photolysis Half-life (pH 7)
Hydrolysis (pH 7)
Water Solubility
Value
54ml/gl
653 days2
Source
00155104
42369901
No available data
29 *»»
Stable
710mg/l
Rhodes, 1975
0001946
EFGWB One-Liner
'MeanKoc
^trapolated half-life
3Photodegradation half-life does not reflect enhanced degradation from photosensitzers.

Table 16: Estimated Environmental Concentrations (EECs) For Aquatic Exposure
Site
Application
Method
Application
Rate
ObsaJL/A}
Initial
(PEAK)
EEC(ppb)
aaUcfay
average
EEC (ppfe)
56-day
average
EEC 
-------
        Tier 1 GENEEC modeling indicates that terbacil' may reach
 surface waters at concentrations ranging from 19 to 154 ptg/L
 (Table 19). The higher EEC's for terbacil correspond with ground
 application  of terbacil at rates of  3.2 Ibs a.i./A/season  on
 sugarcane, apples, peaches, blueberry, and poplar-Kentucky.  A
 more refined  Tier H PRZM-EXAMS modeling for sugarcane,
 peaches, and apples was used for the dietary risk assessment. More
 refined modeling was not conducted for blueberries and hybrid
 poplar because they have a limited production area.  Tier n surface
 water modeling was conducted using the following scenarios:
Table 17: Tier H PRZM-EXAMS Modeling Input Parameters
Crop
Peaches
Sugarcane
Apples
Location
Peach Co., GA
Jackson Co., LA
Washington Co., OR
Columbia Co., NY
Weather (MLKA)
P133A
O-134
A2
144B
Soil
Boswell sandy loam (D)
Commerce silt loam ®
Cornelius silt loani ®
Sharkey clay loam (D)
Soil Taxonomy
Vertic Paleudalf
Aerie Huvaquvent
Mollic Fragixeralf
Vertic Haplaquept
(. ^-Indicates Hydrologic Soil Grouping
       The runoff scenarios were conducted using the standard 1:10
 ratio farm pond watershed. Conservative runoff simulations were
 conducted from 1948 to 1983. Actual weather data were used for
 the 36 year simulation (Burns, et al. 1992); Average annual EECs
 in the water column were calculated for the peak EEC (immediately
 after loading), 96 hour EEC, 21 day EEC, 60 day EEC, and 90 day
,EEC.   The  runoff simulations  were conducted for Hydrologic
 Group C and D soils.  Group C and D soils are considered to be
 more suspectable to  runoff because of lower saturated hydraulic
 conductivities (K^ < 1.417 inches/hr) and/or high water tables
 (SCS, 1993). The soil classification for Commerce and Sharkey
 soils (e.g.,  aquic moisture  regime) indicates the presence of
 seasonally high water tables.  The Environmental Fate Division
notes the Sharkey soil. classification for the New  York apple
scenario was derived from an outdated soil survey manual. More
recent soil classification indicates the Sharkey soil  is found in
Mississippi and Louisiana.  The  soil classification of the Sharkey
and Boswell soils (e.g., Vertic subgroup) contain expansive clays
(e.g., montorillonite).   These soils  may have extensive cracks
which  serve  as   macropores for by-pass flow  conditions.   In
contrast, soil classification of  the  Cornelius soil indicates the
presence of a  fragipan.  A fragipan is expected to limit water flow
through the soil profile.  These specific soil hydrological conditions
were not considered in the environmental fate modeling.
               57

-------
                                 PRZM-EXAMS EECs suggest terbacil may accumulate in
                           static  surface waters from long-term use.  (See below Figure.)
                           Exceedance EECs for terbacil were not calculated because there
                           was residue accumulation in the surface water body with successive
                           annual applications.  Instead, the 36 year cumulative peak EECs are
                           reported as the representative upper bound Tier n EECs (Table 2).
                           The PRZM-EXAMS cumulative peak EECs were 63 jig/L (70% of
                           est. HA)  for peaches, 1470  ^g/L  (1500  %  of est HA)  for
                           sugarcane,  28 /tg/L  (31% of est. HA) for western apples, and 178
                           fig/L (198% of est. HA) for eastern apples. Further analysis of the
                           Tier  II peak EECs indicate the first  year   EEC and  annual
                           incremental concentration  (slope)  were  105  and 36 jtg/L for LA
                           sugarcane, 24 and 4.3 /tg/L for NY apples, 34 and 0.81 ^g/L for
                           GA peaches; and 5.2  and  0.52 /tg/L for WA apples. The annual
                           incremental concentration  was derived from the slope of a linear
                           regression models fit to Tier n peak EECs accumulation over a 36
                           year computer simulation period. There  is uncertainty in the slope
                           estimates for GA peaches and WA apples because of a poor fit of
                           the linear regression models.  Results of the simulation suggest
                           that surface water runoff may be an important route of dissipation
                           for terbacil. The model  predicted  accumulation of  terbacil  in
                           surface waters may be an  artifact  of the computer simulation  for
                           several reasons:  1.) surface water  hydrology of the pond does not
                           account for outflow and/or dilution  processes; and 2.)  aerobic
                           aquatic metabolism  for terbacil was not considered as a route of
                           dissipation.

Table  18:  Tier  n  Maximum PRZM-EXAMS   Aquatic Estimated  Environmental
Concentrations for Terbacil
Crop
Peaches
Sugarcane
Apples
Location
GA
LA
OR
NY
Rate
kg a.i./faa
2.554
3.400"
2.980
3.400
jPeakEEC
tepfc)
63
1470
28
178
Day 4 EEC
(PI*>
63
1460
28
177
Day 21 EEC

-------
               parishes: Cameron,  Point Coupee,  Madison,  West Feliciana,
               Rapides, and Richland.  The 1992 Census of Agriculture indicates
               that sugarcane production in Louisiana can be found only  in Point
               Coupee Parish (12,583 acres or 4% of production area) and Rapides
               Parish (2,336 or 0.65% of the production area).  GIS analysis of
               the terbacil use area in Louisiana indicates that Point Coupee is the
               only parish to overlap the terbacil use area (See attached Figures).
               The integration of the sugarcane production area and monitoring
               data suggests STORET monitoring data for  terbacil may not be
               representative of the sugarcane production area.  Surface water
               drinking water facilities on major rivers and bayous are present in
               the  sugarcane production  area and serve a total population of
               148,200 people  (ReachScan, 1991).  Activated charcoal filtration
               is not expected to remove terbacil from surface water  because
               terbacil sorption affinity (expressed as a Kj) does not appear to be
               dependent on the organic carbon content of soils.
Figure 3 - PRZM-EXAMS TERBACIL (Surface Water Concentrations)
1400 -
1200 •
1000-
t 800 •
.3
^ 600 -
1
o 400 -
»
* 200 -

PRZM-EXAMS TERBACIL
Surface Water Concentrations






••





> ' *
•/~~
0 •*=
194,




	




-s£L
—p.









™X!~
ir*





— : 	 	 	


	 	 .*^^t

J/^ .




	 : 	 .j




'?*"











*esHL







B 1953 1958 1963
Yeats of Application




"










^ —










1968 19:

-gn^^

	







73

•MEEuunw








••— -a^i
--^«
x*"1-











^^-













1978 1983
— LA Cane — -WA Apples 	 NY Apples - — - GA Peaches

3.     Exposure and Risk Characterization

       A  means of integrating the results of exposure and ecotoxicity data is
called the quotient method. Fortiiis method, risk quotients (RQs) are calculated
by dividing exposure estimates by ecotoxicity values, both acute and chronic.

                             59

-------
       RQ = EXPOSURE/TOXICITY

       RQS are then compared to OPP's levels of concern (LOCs). These LOCs
are criteria used by OPP to indicate potential risk to nontarget organisms and the
need to consider regulatory action.  The criteria indicate that a pesticide used as
directed has the potential to cause adverse effects on nontarget organisms.  LOCs
currently address  the following risk presumption categories: (1) acute  high -
potential for acute risk is high, regulatory action may be warranted in addition to
restricted use classification (?) acute restricted use - the potential for acute risk
is high,  but this may be mitigated through restricted use classification (3) acute
endangered  species - the potential for acute risk to endangered species is high,
regulatory action  may be warranted, and (4) chronic risk - the potential for
chronic risk is high, regulatory action may be warranted.  Currently, the Agency
does not perform assessments for chronic risk to plants, acute or chronic risks to
nontarget insects, or chronic risk from granular/bait formulations to mammalian
or avian species.

       The ecotoxicity test values (i.e., measurement endpoints) used in the acute
and chronic  risk  quotients are  derived from the  results  of required studies.
Examples of ecotoxicity values derived from the results of short-term laboratory
studies that assess acute effects are: (1) LC50 (fish and birds) (2) LD50 (birds and
mammals (3)  EC50  (aquatic plants and aquatic invertebrates) and (4) EC25
(terrestrial plants).  Examples of toxicity test effect levels derived from the  results
of long-term laboratory studies that assess chronic effects are: (1) LOEC  (birds,
fish, and aquatic invertebrates) (2) NOEC (birds, fish and aquatic invertebrates)
and (3)  MATC (fish and aquatic invertebrates).  For birds and mammals,  the
NOEC value is used as the ecotoxicity  test value in assessing chronic effects.
Other values  may be used when justified. Generally, the MATC (defined as the
geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in
assessing chronic effects to fish and aquatic invertebrates. However, the NOEC
is used if the measurement end point is production of offspring or survival.

       Risk presumptions,  along with the corresponding  RQS and LOCs  are
tabulated in Table 19 below.
                             60

-------
 Table 19: Risk Presumptions for Terrestrial Animals
Bisk Presumption
RQ
' -' - \ Blras '
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EECVLC50 or LD50/sqft or LDso/day3
EEC/LCSO or LDso/sqft or LDso/day (or LD50 < 50 mg/kg)
EEC/LCSO or LD50/sqft or LDso/day
EEC/NOEC
- " - ' Wild Mammals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC/LC50 or LD50/sqft or LDso/day
EEC/LCSO or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)
EEC/LCSO or LD50/sqft or LD50/day
EEC/NOEC
LOC
'
0.5
0.2
0.1
1

0.5
0.2
0.1
1
      me/ft2	  3 mg of toxicant consumed/day
  LD50 * wt. of bird
LD50 * wt. of bird
 Table 20; Risk Presumptions for Aquatic Animals
Risk Presumption _
Acute High Risk
Acute Restricted Use
Acute Endangered Species,
Chronic Risk
, ^ RQ ^»
EECVLCsoorECso
EEC/LC50orEC50
EEC/LCsoorECso
EEC/MATCorNOEC
'EEC = (ppm or ppb) in water '
HfcOC
0.5
0.1
0.05
1

,v Risk Presumption
^ "" %
T«rres6rlal Plants
Acute High Risk
Endangered Species
EECVEC25
EEC/EC05orNOEC
, Aqtta1»iJ?|ant$
Acute High Risk
Endangered Species
EEC2/EC50
EEC/EC05 or NOEC
!EEC = Ibs a.i./A , . ~ — '
\ i,d'ev'
-
i
i

i
i

2EEC = (ppb/ppm) in water
                   a.
    Ecological Exposure and Risk Characterization



    (1)    Exposure and Risk to Nontarget Terrestrial Animals
            *


          For pesticides applied as a nongranular product (e.g., liquid,

    dust), the estimated environmental concentrations (EECs) on food
                                        61

-------
                            items following product application are compared to LCSO values to
                            assess risk. The predicted 0-day maximum and mean residues of a
                            pesticide  that may be  expected to  occur on selected avian or
                            mammalian food items  immediately following  a direct  single
                            application at 1 Ib a.i./A are tabulated in Table 22 below.

Table 22: Estimated Environmental Concentrations on Avian and Mammalian Food Items
;Foo5 Items
Short grass
Tall grass
Broadleaf/forage plants, and small insects
Fruits, pods, seeds, and large insects
EEC j*m)
768
352
432
48
fcC^iMn)
21141
21141
21141
21141
! Acute RQ
(jEEC/LCa,)
- 0.04
0.02
0.02
0.00
'The LCjo for pheasant was used as a toxicity endpoint for birds because pheasant was the only agency approved species
with a measurable LC^,. All other approved species have greater LC50's when compared to pheasants.
2Since the highest rate of application did not exceed any LOG for the level of acute risk, RQ's for lower application
rates were not calculated.

                                          There  is  no  acute  risk  to birds at the  highest
                                   application rate (3.2 Ibs a.i./acre) for terbacil.  A chronic
                                   risk assessment for birds can not be made because of lack
                                   of reproduction data.

                                   (b)    Mammals

                                          Estimating the potential for adverse effects to wild
                                   mammals is based upon the Environmental Fate's draft 1995
                                   SOP of mammalian risk assessments and methods used by
                                            62

-------
                                  Hoerger and Kenaga (1972) as modified by Fletcher et al.
                                  (1994).  The concentration of Terbacil in the diet that is
                                  expected to be acutely lethal to 50% of the test population
                                  (LCjo) is determined by dividing the LDSO value (usuaUy rat
                                  LDso) by the % (decimal of) body weight consumed.  A risk
                                  quotient is  then determined by  dividing the EEC by the
                                  derived LC5o value. Risk quotients are calculated for three
                                  separate weight classes of mammals (15, 35, and 1000 g),
                                  each presumed to consume four different kinds of food
                                  (grass, forage, insects, and seeds). The acute risk quotients
                                  for 3.2  Ib  a.i./A broadcast  application  of terbacil are
                                  tabulated in Table 24 below.

Table 24: Mammalian (Berbivore/Insectivore) Acute Risk Quotients for Single Application
of Nongranular Products (Broadcast) of Terbacil2
Application
Kate
m Ibs a.L/^'
3.2*
3.2
3.2
Bo%
Weight
®
15
35
1000
•>f I T\ >
% Body '
Wefeiit
Consumed
95
66
15
Rat
£»*
(«£/&$
5000
5000
5000
EEC
Forage & '
Small Jnsecfc
432
432
432
EEC

-------
Table 25: Mammalian Chronic Risk Quotients for Terbacil Based on a Rat NOEL >250
ppm in a 3-generation rat study
; ^ '', %£/ '' ''I '
SIte/AjJplieatioB M«tfioa
v. v Tf ,SV "">*, < , , - ' •
Sugarcane, peach, apple,
blueberry.
Popular - Kentucky.
(ground application)
Asparagus
(ground application)
Sugarcane
(aerial application)
Alfalfa - north eastern states
(ground application)
Mint, Caneberries, Poplar -
Washington and Oregon
(aerial and ground
application)
Alfalfa
(aerial and ground
application)
Strawberry, Grass Seed -
Oregon (ground application)
'^ji^^Mi'" *
-B^-ia^a^l'':
3.2
2.4
2.0
1.8
1.6
1.2
1.0
Fwdltssas ,''"', -I
' f f f ,, :
Short grass
Tall grass
Broadleaf plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf plants/Insects
Seeds
Short grass
Tall Grass
Broadleaf plants/Insects
Short grass
Tall Grass
Broadleaf plants/Insects
Short grass
Tall Grass
Broadleaf plants/Insects
Short grass
jMaxiaSuKt-
m
-------
used for assessing acute and chronic risks to aquatic organisms.
Acute risk assessments are performed using peak EEC values for
single and multiple applications.  Chronic risk assessments are
performed using the 21-day average EECs for invertebrates and 56:
day EECs for fish.

      (a)    Freshwater Fish
              i
             For a possible "worst case" scenario for acute risk,
      a direct application of terbacil to 6 inches of water should
      result in the highest possible exposure to aquatic organisms
      from the labeled use of terbacil.   The only scenario for
      direct exposure to water would be from aerial application to
      alfalfa, mint and  sugarcane.   A  simple dilution of the
      maximum rate of application for terbacil (3.2 Ib a.i./A) to
      a surface acre of water at 6 inches deep is expected to yield
      a maximum concentration of 2,316 ppb .  Since aerial
      application is assumed to have a 60% application efficiency,
      aquatic organisms will be exposed to 1380 ppb. The lowest
      LC5o  for fish is 46.2 ppm for rainbow trout.  The  risk
      quotient (RQ) is derived by dividing the exposure (1.4 ppm)
      by the toxicity value (46^2 ppm).  The RQ for freshwater
      fish is  0.03 which is below the level of concern (LOG) for
      fish.   A chronic  risk assessment cannot be completed
      because of  insufficient toxicity data.

      (b)    Freshwater Invertebrates

             For a possible "worst case" scenario for acute risk,
      a direct application of terbacil to 6 inches of water should
      result in the highest possible exposure to aquatic organisms
      from the labeled use of terbacil.   The only scenario for
      direct exposure to water would be from aerial application to
      alfalfa, mint and sugarcane.  A simple dilution of the
      maximum rate of application for terbacil (3.2 Ib a.i./A) to
      a surface acre of water at 6 inches deep is expected to yield
      a maximum concentration of 2,316 ppb.   Since  aerial
      application is assumed to have a 60% application efficiency,
      aquatic organisms will be exposed to  1,380 ppb.  The lowest
      LC50  for aquatic invertebrates is  65  ppm for Daphnia
      magna.  The risk quotient (RQ) is derived by dividing the
      exposure (1.4 ppm) by the toxicity value  (65 ppm).  The
      calculated RQ for freshwater fish is  0.02 which is below
      the levels of concern (LOG) for aquatic invertebrates. A
               65

-------
       complete chronic  risk assessment cannot  be completed
       because of  insufficient toxicity data.

       (c)     Estuarine and Marine Animals

              In order to estimate risk to estuarine and marine
       animals, the toxicity values for estuarine/marine animals are
       compared to, the toxicity of freshwater aquatic  animals.
       Estuarine/marine fish is less sensitive to terbacil than the
       freshwater fish.  The estuarine/marine aquatic invertebrates
       have similar toxicity values to the freshwater invertebrates.
       Based  on  the  risk  quotients  for  freshwater fish  and
       invertebrates, it is assumed the LOCs will not be exceeded
       for  estuarine/marine  animals  from  the  labeled use of
       terbacil.  A chronic risk assessment cannot be completed
       because of insufficient toxicity data.

(3)     Exposure and Risk to Nontarget Plants

       (a)     Terrestrial and Semi-aquatic

              Terrestrial plants may be exposed to pesticides from
       runoff,  spray drift or volatilization. Plants in  semi-aquatic
       areas are those that inhabit low-lying wet areas that may be
       dry  at certain times of the year. The Environmental Fate
       Division's runoff scenario is: (1)  based  on a  pesticide's
       water solubility  and the amount of pesticide present on the
       soil surface and its top one inch (2)  characterized as "sheet
       runoff' (one treated acre to an adjacent acre) for terrestrial
     .  plants  (3)  characterized  as  "channelized  runoff'  (10
       treatedacres to a distant low-lying acre) for semi-aquatic
       plants and (4) based on %  runoff values of 0.01, 0.02, and
       0.05 for water solubility of < 10 ppm, 10-100 ppm,  and
       > 100 ppm, respectively.  Spray drift exposure from ground
       application  is assumed to be 1 % of the application rate.
       Spray drift from  aerial, airblast, forced-air, and chemigation
       applications is assumed to be 5% of the, application rate.
       EECs are calculated for the following application methods:
       (1) unincorporated  ground applications,  (2)  incorporated
       ground  application, and (3) aerial, airblast, forced-air,  and
       chemigation applications.  Formulae for calculating EECs
       for terrestrial plants inhabiting areas adjacent to treatment
       sites and EECs  for plants in semi-aquatic areas are in an
       addendum.   Estimated environmental concentrations for
               66

-------
 terrestrial and semi-aquatic plants are tabulated in table 26
 below.
Table 26: Estimated Environ]
Aquatic Plants for a Single A
Sfce/AgpiifcatiOB % ^ ''"' ,
M&h6& £ate t£Jg$f&tit>i%ita.B£*£st£r
rffsff f f
	 «,,,,,-'
Sugarcane, peach, apple, blueberry
Popular- Kentucky (Unincoiporated Ground)
3.2
Asparagus (Unincorporated Ground) 2.4
Sugarcane (Unincorporated Ground) 2.0
Sugarcane (Aerial) 2.0
Alfalfa- Northeast States (ground) 1.8
Mint, caneberries Poplar- Washington,
Oregon (Unincorp. Ground) 1.6
Mint (aerial) 1.6
Alfalfa (Aerial) 1.2
Alfalfa (Unincorporated Ground) 1.2
Strawberry (Unincorporated Ground). 1.0
Grass Seed- Washington (Ground) 0.6
Strawberry (Ground) 0.4
mental Concentrations (Ibs a.i./A) For Terrestrial and Semi-
pplication
•wBuUBUJlJSt
Snc»Tp<»,
fi^&frt^
0
0
0
0
0
0
0
0
0
0
, o
0
BunoB
'Vkh»
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
' Steeds
XiHWf£r
$bs
a.UA|
0.16
0.12
0.10
0.06
0.09
0.08
0.05
0.04
0.06
0.05
0.03
0.02
CliiutneSze
dSttrwS
^M./A?
1.60
1.20
1.00
0.36
0.90
0.80
0.30
0.24
0.60
0.50
0.30
0.20
ftift
4-J&S
£*-«&
0.03
0.02
0.02
0.10
0.02
0.02
0.08
0.06
0.01
0.01
0.01
0.00
: "TofaiioBiateg'
•to AdgaeeBt:
. A*#.m&$'"
•Ktta^«*Jirtft)
. 0.19
.0.14
0.12
0.16
0.11
0.10
0.13
0.10
0.07
0.06
0.04
X0.02
Total £oafif+
»rfft)
1.63.
1.22
1.02
0.46
0.92
0.82
0.38
0.30
0.61
0.51
0.31
0.20
       The ECjs value of the most sensitive species in the
seedling emergence study is compared to runoff plus drift
exposure  to  determine the risk quotient (EEC/toxicity
value).  The EC^ value of the most sensitive species in the
vegetative vigor study is compared to the drift exposure to
determine the acute risk quotient. EECs and acute high risk
quotients for terrestrial and semi-aquatic plants based on a
single application are tabulated in Table 27 below.
        67

-------
Table 27: Acute High Risk Quotients from a Single Application
Aquatic  Plants Based On a (rape) Seedling  Emergence EC25
(cucumber) Vegetative Vigor EC25 of 0.0022 Ib aa./A	
                                                                    for Terrestrial and Semi-
                                                                    of 0.013 Ib a.i./A and a
                               '$£&$,"
                                                                     Htmte
                                                                              Aqwrfic
Sugarcane, peach, apple,
blueberry (Ground) 3.2
                       0.013
                                0.0022
                                        0.03
                                                 0.19
                                                             1.63
                                                                      14.62
                                                                              125.38
                                                                                        13.64
Asparagus (Ground) 2.4
                       0.013
                               0.0022
                                        0.02
                                                 0.14
                                                             1.22
                                                                      10.77
                                                                               93.85
                                                                                        9.09
Sugarcane (Ground) 2.0
                       0.013
                               0.0022
                                        0.02
0.12
            1.02
                      9.23
                              78.46
                                                                                        9.09
Sugarcane (Aerial) 2.0
                       0.013
                               0.0022
                                        0.10
                                                 0.16
                                                             0.46
                                                                      12.31
                                                                               35.38
                                                                                        45.45
Alfalfa- Northeast
(Ground) 1.8
                       0.013
                                0.0022
                                        0.02
                                                 0.11
                                                             0.92
                                                                       8.46
                                                                               70.77
                                                                                        9.09
Mint, canebenies
(Ground) 1.6
                       0.013
                                0.0022
                                        0.02
                                                 0.10
                                                             0.82
                                                                       7.69
                                                                               63.08
                                                                                        9.09
Mint (Aerial) 1.6
                       0.013
                               0.0022
                                        0.08
                                                 0.13
                                                             0.38
                                                                      10.00
                                                                               29.23
                                                                                        36.36
Alfalfa (Aerial) 1.2
                       0.013
                               0.0022
                                        0.06
                                                 0.10
                                                             0.30
                                                                       7.69
                                                                               23.08
                                                                                        27.27
Alfalfa (ground) 1.2
                       0.013
                               0.0022
                                        0.01
                                                 0.07
                                                             0.61
                                                                       5.38
                                                                               46.92
                                                                                        4.55
Strawberry (ground) 1.0
                       0.013
                               0.0022
                                        0.01
                                                 0.06
                                                            0.51
                                                                      4.62
                                                                               39.23
                                                                                        4.55
Grass Seed- Washington
(Ground) 0.6
                       0.013
                               0.0022
                                        0.01
                                                 0.04
                                                             0.31
                                                                       3.08
                                                                               23.85
                                                                                        4.55
Strawberry (Ground) 0.4
                       0.013
                               0.0022
                                        0.00
                                                 0.02
                                                             0.20
                                                                       1.54
                                                                               15.38.
                                                                                        0.00
                                           The  results indicate that for a single application,
                                    acute  risk and endangered species  levels of concern are
                                    exceeded for terrestrial and semi-aquatic plants (including
                                    endangered  species) for all registered application rates of
                                    terbacil.    Currently, the Agency  does  not  perform
                                    assessments  for chronic risk to terrestrial and semi-aquatic
                                    plants.  The NOEC or EC05 (if NOEC is unavailable) value
                                    of the most sensitive species in the seedling emergence study
                                    is compared to runoff plus drift exposure to determine the
                                    endangered  species risk quotient.   The NOEC  or EC05
                                    value of the most sensitive species in the vegetative vigor
                                    study  is compared to the drift exposure to  determine the
                                    endangered species risk quotient.  Since the LOCs for non-
                                    target plants are  exceeded at all rates of application,  it is
                                    assumed  that  the labeled use  of terbacil  may  affect
                                    endangered species of plants.

                                    (b)    Aquatic

                                           Exposure to nontarget aquatic  plants  may occur
                                    through runoff or spray drift from adjacent treated  sites or
                                    directly from such uses as aquatic weed or mosquito larvae
                                    control. An aquatic plant risk assessment for acute risk is
                                              68

-------
usually performed  for  aquatic vascular plants from the
surrogate duckweed Lemna gibba.   Non-vascular acute
aquatic plant risk assessments are performed using either
algae or a diatom, whichever is the most sensitive species.
An aquatic plant risk assessment for endangered species is
usually performed  for  aquatic vascular  plants from the
surrogate duckweed Lemna gibba. , To date there  are no
known non-vascular plant species on the endangered species
list.   Runoff and  drift  exposure  is   computed  from
GENEEC.  The risk quotient is determined by dividing the
pesticide's initial or peak concentration in water by the plant
EC$o value.  Acute risk quotients for vascular and non-
vascular plants are tabulated in Table 28 below.
Table 28: Acute Risk Quotients for Aquatic Plants based upon a duckweed (Lemna gibba)
ECso of 0.140 ppm a.i. and a nonvascular plant (Navicula pefficulosa) EC^ of 0.011 ppm a i
For endangered species, the L. gibba NOEC of 0.065 own a.L.
WX&SZrimy&^'Sttfret ' '''
%>lwartl&»4ttjfejiax^ ,- „ ' \i
Sugarcane, peach, apple, blueberry and
Poplar- Kentucky (Ground)
3.2
Asparagus (Ground)
2.4
Sugarcane (Ground)
2.0
Sugarcane (Aerial) ,
2.0 >
Alfalfa- Northeast (Ground)
1.8
Mint, caneberries (Ground)
Poplar- Washington, Oregon
1.6
Mint (aerial)
1.6
Alfalfa (Aerial)
^•2
Alfalfa (Ground)

Strawberry, Grass Seed - Oregon (Ground)
1.0 .
Grass Seed - Washington (Ground)
0.6
Strawberry (Ground)
0.4
:%edffeg- -• , '
duckweed
algae or diatom
duckweed
algae or diatom
duckweed .
algae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
duckweed
Igae or diatom
duckweed
algae or diatom
duckweed
algae or diatom
uckweed
ilgae or diatom
"»s¥"
lyu^-
&m
0.140
0.01]
0.14C
0.011
0.14C
0.011
0.14C
0.011
0.140
0.011
0.140
3.011
31140
3.011
).140
).011
).140
).011
).140
):011
).140
).011
1.140
l.Oll
^C
^>
0.065
, 	
0.065
• — _
0.065
	
0.065
	
0.065
	
0.065
	
0.065
	 .
0.065
	
0.065

0.065
	
0.065
	
0.065
	
Endanger^
Species »q
$BCftiQ8C
2.37

L77

1.48

1.46
-— .
1.32
	 	
1.15

1.17
' .....
0.86
_ —
0.88
— _
0.74

0.43

0.29
— _
: $3a-ferg!et
'$te&tM)>
i-CEBCyiSSC^),
1.10
14.00
0.82
10.45
0.69
8.73
0.68
8.64
0.61
7.82
0.54
6.82
0.54
6.91
0.40
5.09
0.41
5.18
0.34
4.36
0.20
2.55
0.14
1.73
        69

-------
                    The LOG for non-target aquatic vascular plants are
             exceeded at all application levels.  The LOG for algae or
             diatoms are not exceeded at any level of rate of application.
             The LOG  for endangered species  of aquatic plants are
             exceeded at 1.6 Ib a.i./A application rate or higher. (Non-
             vascular endangered species are not known to exist at this
             time).

       (4)    Endangered Species

             Endangered species LOCs  are exceeded  for mammals
       (chronic basis) and non-target terrestrial/ aquatic  plants.   The
       Endangered Species Protection Program is expected to become final
       in the future.  Limitations in the use of terbacil will be required to
       protect endangered and threatened species, but these limitations
       have not been defined and may be formulation specific. The Agency
       anticipates that a consultation with the Fish and Wildlife Service
       will be conducted in accordance with the  species-based priority
       approach  described  in  the  Program.    After completion of
       consultation, registrants  will be informed if any required label
       modifications are necessary. Such modifications would most likely
       consist of the generic label statement referring pesticide users to use
       limitations contained in county Bulletins.

b.     Water Resources Risk Implication for Human Health

       The Agency concludes  that terbacil can potentially  move into
ground and surface  waters.  However, the fact that  terbacil is used
exclusively on minor crops with very localized site conditions is expect to
limit the potential ecological  and human exposure;

       (1)    Ground Water

             In general, the soils in the terbacil use area are classified as
       Hydrologic Group B  soils.   However,  terbacil use  areas  with
       potentially vulnerable groundwater are expected to be associated
       with mint production in the Pacific Northwest and Midwest (TL and
       IN) as well as the sugarcane production in Louisiana and southern
       Florida.  The sugarcane production  area of Louisiana also has a
       high concentration of Hydrologic Group C/D soils which are prone
       to  runoff.    Additionally, the  sugarcane production areas are
       expected to have GW/SW interactions because of the presence of
       high water tables.
                      70

-------
                     PATRIOT modeling suggest that terbacil could contaminate
              very shallow ground water (2.5 to 5 feet) at high concentrations.
              The SCI-GRO screening model predicts that the maximum chronic
              concentration of terbacil in shallow groundwater (1Q-30 feet) is not
              expected to exceed 125 pg/L for the majority of the use sites.
              (2)     Surface Water

                     The water resource assessment for terbacil indicates that
              terbacil can move into ground and surface waters.  The maximum
              GENEEC EEC for terbacil was 154 jig/L for sugarcane, apples,
              and peaches at application rates of 3.2 Ibs a.i./A.

                     Tier n surface water assessments were focused on the major
              productions areas for sugarcane, peaches, and apples.,  These
              growing areas are located: 1) Pacific Northwest Region (OR and
              WA) for apples/peaches ; 2) Mid-Atlantic Region (NY) for apples;
              3) southern Piedmont Region (GA) for peaches; and 4) Mississippi
              River Delta Region (LA) for sugarcane.  Tier II surface water
              assessments indicate that terbacil can potentially accumulate in the
              "farm pond" runoff scenario.  Cumulative 36 year Tier IIPRZM-
              EXAMS  concentrations ranged from  28 jig/L  for' apples  in
              Washington to 1470  /ig/L for sugarcane in Louisiana.  Further
              analysis of Tier n EECs indicate the first year EEC and annual
              incremental concentration (slope) were  105 and 36 ^g/L for LA
              sugarcane; 24 and 4.3 /tg/L for NY apples; 0.00 and 0.81 /ag/L for
              GA peaches; and, 5.2 and 0.52 pg/L for WA apples. Predicted
              terbacil accumulation in the "farm pond" runoff scenario may be
              high  because some potential  routes   of dissipation   (e.g.>
              metabolism, dilution, etc.)  have not been taken into account in the
              surface water modeling.  Drinking water  derived, from surface
              waters is expected have concentrations less than  the farm-pond
              scenario.

4.     Environmental Risk Characterization
     f •   '                               '                 •         .
       The risk analysis indicates terbacil is a  persistent and potentially mobile
herbicide in terrestrial environments.  These environmental fate properties also
suggest that terbacil can potentially move into both ground and surface waters. The
available ground and surface water monitoring  data are not representative of the
terbacil use area. Hence, estimated environmental concentrations of terbacil are
based solely on ground and surface water models.                           .
                             71

-------
       Tier II surface modeling suggest terbacil may potentially accumulate in
surface water at concentrations ranging from 28 to 1470 /tg/L. Further analysis of
Tier  II  peak EECs indicate  the first year  EEC and annual  incremental
concentration (slope)  were 105 and 36 /ag/L for LA sugarcane; 24'and 4.3 jtg/L
for NY apples; 0.0 and 0.81 /ig/L for GA peaches; and 5.2  and 0.52 /ag/L for
WA apples . The annual incremental concentration was derived from the slope of
a linear regression models fit to Tier II peak EECs accumulation over a 36 year
computer simulation period. The peak ground water concentration, based on the
SCI-GRO screening model,  is not expected to exceed 125 /*g/L.

       Minimal  adverse acute effects are expected for avian, mammalian, and
aquatic species from labeled uses of terbacil.  Chronic effects for avian and aquatic
species cannot be evaluated at this time because of insufficient data.  However,
chronic RQs for mammals indicate that adverse effects are possible from labeled
uses  of  terbacil.    There is some uncertainty • in  assessing adverse  chronic
mammalian effects because the NOEL is greater than the maximum concentration
tested in rat reproduction study design.  Therefore, the highest concentration is a
default toxicity endpoint which is a conservative estimate of risk.  Since terbacil
is a persistent and mobile herbicide,  non-target terrestrial plants are expected to
be adversely affected from  runoff and spray drift.  Minimal adverse effects,
however,  are expected for  non-target aquatic plants.  Because terbacil is used
exclusively on minor crops, terbacil exposure is expected to be very localized and
dependent on site specific conditions. The localized nature of terbacil use areas is
expected to limit human and ecological exposure.

       Additional data are needed for a complete risk assessment. Chronic toxicity
studies (71-4 Avian Reproduction Study ; 72-4 Fish Early Life Stage and Aquatic
Invertebrate Life Cycle) are needed to assess chronic risk to  avian and aquatic
organisms.  Wild mammal toxicity study (71-3) is reserved pending a review of
avian reproduction studies. Aerobic aquatic metabolism data (162-4) are needed
to assess the rates and routes of terbacil dissipation in aquatic environments.

5.     Integrated Risk Characterization

       Analysis of the use characterization information indicate terbacil is used in
localized regions  across the United States. These regions have varying potentials
for runoff because of the agronomic/ horticultural practices, climatic conditions,
and site characteristics.   Since terbacil is  used exclusively on perennial crops
(except sugarcane), a continuous ground cover or minimal soil  tillage is expected
which should reduce the  potential for runoff. Climatic data indicate the range in
average precipitation can range from 10 to 70 inches  in Washington and Oregon
to 45-65  inches hi LA.  Additionally, soil data indicate  the terbacil use areas are
predominately Hydrologic Group B soils.  Hydrologic Group  D soils, however,
are a dominate soil type in the sugarcane production area of LA.   In comparison
                             72

-------
 to other terbaca use sites, the runoff potential for terbaca is expected to be greater
 in the sugarcane production area. Aerial applications of terbacil is limited to mint,
 alfalfa, and sugarcane. These uses are expected to pose the greatest drift potential
 of terbacil. Based solely on terbacil use data, approximately one-half of the total
 terbacil use area is associated with mint production in the Pacific Northwest,
 Indiana, and Illinois.  Since the Pacific Northwest region is a major production
 area which has relatively low rainfall (east of Cascade Mountains), spray drift of
 terbacil may be an important route of dissipation in this region (Grant, Yakima,
 and Adams Counties in Washington ; Crook and Jefferson Counties hi Oregon).'

        Acceptable  environmental fate laboratory and field  data indicate that
 terbacU is persistent (t1/2=653 days) and mobae (£  =54 ml/g) in terrestrial
 environments.   The predominant routes, of terbaca dissipation are dependent on
 microbial-mediated degradation, photodegradation in water, and movement into
 ground and surface waters.  Since terbaca is expected to move and potentially
 accumulate into  surface waters,  aerobic aquatic metabolism data are needed for a
 more complete environmental fate assessment.

        Ground and surface water modeling indicates that terbaca can potentially
 move into surface waters and shaaow ground water.  The available ground and
 surface water monitoring data cannot be used to estimate terbaca concentrations
 because it is not representative of the terbaca use areas.  Therefore, estimated
 concentrations  are based solely on ground and surface water models.  Since
 terbaca is used exclusively on minor crops with very localized site conditions, the
 Agency concludes the ground and surface water exposure estimates for terbaca are
 site specific and, therefore, are not representative of national exposure estimates.

       Preliminary surface water modeling indicates that terbacil can move into
 surface water at  high concentrations.  The maximum GENEEC EEC for terbaca
 was 154 jig/L for sugarcane, apples, and peaches  at application rates of 3 2 Ibs
 a.i./A.  More refined PRZM-EXAMS modeling indicate terbaca may potentiaay
 accumulate in the surface water (e.g., "farm-pond") from year to year.   Some
 possible reasons for terbaca accumulation in surface water are  as foaows: 1.) The
 "farm-pond" runoff scenario is a static pond with no adjustment for water outflow
 or dilution; and 2.) Aerobic aquatic metabolism  was not considered as a route of
 dissipation for terbaca in surface water.  Since terbaca accumulation in surface
 water was observed in surface water modeling, a probabilistic assessment of
 terbacil    concentration was not conducted.   Instead, the 36 year cumulative
 PRZM-EXAMS, EECs for  terbaca were used as  the representative EECs for
 sugarcane, apples, and peaches.    The cumulative EECs  were  1470 /tg/L
 forsugarcane in LA,  178 /*g/L for apples in NY, 28 Mg/L for apples in OR, and
 63 Mg/L for peaches in GA.  These EECs are considered to be very conservative
because they represent 36 years of a continuous cropping regime.
                            73

-------
      Since the cumulative EECs represent a  36 year accumulation period, a
correction of the  cumulative EECs would be needed to  determine the annual
accumulation. This type of refinement would allow a direct comparison between
PRZM-EXAMS and GENEEC EECs.  Tier II peak EECs indicate the first year
EEC and annual incremental concentration (slope) were 105 and 36 /*g/L for LA
sugarcane; 24 and 4.3 jig/L for NY apples; 0.0 and 0.81 pg/L for GA peaches;
and, 5.2  and 0.52 /tg/L for WA apples . The annual incremental concentration
was derived from the slope of a linear regression models fit to Tier II peak EECs
accumulation over a 36 year computer simulation period.  STORET monitoring
data also indicate terbacil was not detected in surface water.   There is,  however,
uncertainty in the representativeness (or overlap) of the STORET surface water
monitoring data for terbacil use areas.  For example,  only 5 % of the sugarcane
production area  in LA   is  represented by  the  STORET  monitoring  data.
Therefore, most of the surface water monitoring samples in LA were not collected
within the sugarcane production area,

      Terbacil exhibits environmental fate properties  similar to  herbicides
commonly detected in ground water. A generic GW vulnerability screen (GUS)
and more refined PATRIOT  modeling indicate that terbacil has a very high
potential to leach into ground water. The GUS comparison score, based solely on
persistence and mobility, exceeds the GUS score of most herbicides commonly
detected in groundwater (e.g., dicambia, fluometuron, atrazine). Based on ground
water vulnerability screening tools, terbacil is expected to be more mobile than
most herbicides commonly detected in ground water  (e.g., atrazine,  dicamba,
alachlor).  PATRIOT modeling suggest that terbacil could reach shallow ground
water (4.5 feet) at high concentrations. SCI-GRO screening model predicts the
maximum chronic concentration of terbacil in shallow groundwater (10 to 30 feet)
is not expected to exceed 125 jtg/L for the majority of the use sites.

      Avian species are expected to have minimal acute adverse effects from the
labeled uses of terbacil.  Since no chronic data are available for avian species, a
complete chronic avian toxicity assessment cannot be completed at this  time.
Avian reproduction studies are necessary because terbacil  is  a very  persistent
herbicide which is applied during the avian reproduction season (early spring).
Additionally, the RQ for chronic adverse effects to mammals at maximum potential
exposure Kenaga values suggest chronic LOG (RQ=1.0) exceedances may occur.
It is generally assumed birds  are more sensitive  than mammals.  Therefore,
chronic toxicity data (71-4  Avian Reproduction Study) for bobwhite quail and
mallard duck are needed for  a more complete chronic toxicity  assessment of
terbacil.

      Minimal acute adverse effects are expected to mammalian species.  Since
there are no acute LOG exceedances. However there are chronic exceedances for
                            74

-------
  mammals (including endangered species) feeding'on short grasses, tall grasses,
  broadleaf plants, and insects, at application rates greater than 1.2 Ibs a.i./acre.

        The chronic LOC's for mammals are uncertain  at this time. The rat
  reproductive study shows the NOEL to be higher than the greatest concentration
  tested.  This concentration is below the maximum and mean predicted residue
  values (Kenaga/Fletcher) on mammalian food items. Since the rat reproductive
  endpoint is greater than the highest concentration tested, we must use that
  concentration  level  as  a default toxic  reproductive endpoint.  Based on the
  Agency's assessment, no evidence of carcinogenicity was detected. The mammal's
  chronic feeding toxicity studies indicate there may be increased liver and thyroid
  weights at doses between 50 and 250 ppm for dogs, and  1500 ppm for rats. Since
  birds generally are more sensitive than mammals to pesticides, the wild mammal
  toxicity  study (71-3) will  be held in reserve pending  the review of avian
  reproduction studies.

        Freshwater aquatic species are expected to have minimal acute adverse
  effects from labeled terbacil uses.  A chronic risk assessment for aquatic species
  can not be made because of insufficient data.  Early fish life cycle and aquatic
  invertebrate life cycle (72-4) studies are necessary because terbacil is a mobile and
  persistent herbicide that may accumulate in surface water bodies.

   ^     Since estuarine/marine species  and freshwater have similar toxicity,
  minimar adverse effects are expected. Since terbacil is a persistent and mobile
  herbicide with the potential for accumulation in terrestrial environments, it is
,  anticipated that  non-target plants will be exposed  to terbacil  via runoff.   In
  addition, non-target plants are expected to be exposed to terbacil from spray drift
 applications on sugarcane, mints, and alfalfa. At all rates  of applications, terbacil
 can adversely effect non-target plants from a  combination of runoff and drift.
 Based on the runoff exposure model, the LOG exceedances for channelized runoff
 ranges from 15 to 125X. The LOG exceedance for sheet runoff range from 1.5
 to 14.6X.  The LOG exceedance for spray drift can range from 27.3 to 45.5X and
 4.6 to 13.6X for aerial and ground spray application, respectively.

       Mitigation options for  labeled terbacil uses are  associated  with rate
 reductions (reduce rate from maximum rate to typical rate) coupled with label
 advisories for spray drift, groundwater, and surface water.  Table 29 below lists
 typical terbacil application rates.
                              75

-------
Table 29: Typical Terbacil Use Rates
. f f f f vf V> ff *
,,,; ^ f, *,<: '..» >, , :
' - .."•-; '*"£w»< "v ' " , - A
' ,<\v~>, s-< -**'",- i
' t&eSate ', / , f';
' Maxbwsai
^'ITj^ie^ ',.,;
4$i*Bca&*A$ .. ..
Maximum
Alfalfa-AgplicaSoabyAiraswBlias"^fbu,Bfd , ' >
U.S.
NEU.S.
SLN'S: (PA, VA)
(WA, OR) Seedling Alfalfa
(MM) Aerial Use
(OK)
Supplemental Aerial Use
Apples, Peaches-Broadcast and Banded
Asparagus-Broadcast
Blueberries-Broadcast and Banded; Ground Only
Caneberries-Broadcast, Ground Only
Mint-Ground and Air°
M/2LB/A/YR
2 1/4 LB/A/YR
1/2 LB/A/YR
1 1/2. LB/A/YR
1 1/2 LB/A/YR
2 1/4 LB/A/YR
1 1/2 LB/A
4 LB/A/YR
3 LB/A/YR
4 LB/A/YR
2 LB/A/YR
2 LB/A/YR
1 to 1 1/2
1 1/2
1/2 LB
1 1/2 LB
1 1/2 LB
1 1/2-2 LB
1 1/2
2-4*
1.5-2.5"
2-3 LB
2LB
2LB
2
2
2
1
1
2
1
.1
2
1
1
1
*$$$£&"
f
1
1-2
2
1
1
1-2
1
1
1-2
. 1
1
1
Sugarcatte-Briwdcastaad'Baaded, Ground «n.d Air*, -- , ~ - -' - - , " ' ;
(LA)
(TX)
(HD
(PR)
Strawberries-Banded, Ground Only;
Recommended by Supplemental Label Only
4 LB/A/YR
4 LB/A/YR
2 1/2 LB/A
2 1/2 LB/A
1/2 Ib/A
1 1/2-24/10
1-2 LB
1-2 1/2 LB
1-2 1/2 LB
1/2 LB
3
2
1
1
1
2
2
1
1
1
3^bridsPopSEars-Baad^€hx>«ndOaiy ' - .. ,
SLN'S: (OR, WA)
2 LB/A
2LB
1
1
Grass Seed-Broadcast^ Ground Only;. Forage Seserictioa ' " '
SLN (ID)
SLN (OR)
SLN (WA-East of Cascades)
1LB/A
1 1/4 LB/A/YR
1 LB/A/YR
1LB
1 1/4 LB
1LB
1
1
1
1
1
1
'Based on organic matter
bA single use application
"Aerial use is limited

       Since terbacil is persistent and mobile herbicide, terrestrial non-target plants can be
adversely impacted from spray drift and runoff at all application rates.  Additionally, terbacil
exhibits properties of pesticides commonly detected in surface and ground waters.  Analysis of
the usage data indicate that typical application rates of terbacil are generally  lower than the
maximum labeled application rates.  For example, the typical application rate for sugarcane is
approximately  one-third of the maximum application rate.  Maximum label application rates
should be more representative of typical application rates. Standard label advisories for spray
drift, ground and surface waters are recommended to alert  users of  potential environmental
impacts from terbacil.  Other mitigation   factors taken into account are :  1.) the limited
                                           76

-------
geographical extent of the current terbacil use area and 2.) Labeled  terbacil application rates are
determined according to the soil organic matter content.  These factors  are expected to limit
potential ground and surface water contamination.  However, the use of terbacil on major crops
would require a re-evaluation of the water resource assessment.  Specifically, expanded use of
terbacil may trigger the need for a small-scale prospective ground water study and surface water
monitoring.
IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.     Determination of Eligibility

              Section 4(g)(2)(A) of FIFRA requires the Agency to determine, after submission
       of relevant data concerning an active ingredient, whether products containing the active
       ingredient are eligible for reregistration.  The Agency has previously identified and
       required the submission of the generic (i.e. active ingredient specific) data required to
       support reregistration of products containing terbacil as the active ingredient.  The Agency
       has completed its review of these generic data, and has determined that the data are
       sufficient to  support  reregistration of all  products containing terbacil.   Appendix B
       identifies  the generic data requirements  that  the Agency reviewed  as part  of its
       determination of reregistration eligibility of terbacil, and lists the. submitted studies that
       the Agency found acceptable.

             The data identified in Appendix B were sufficient to allow the Agency to  assess the
       registered uses of terbacil and to determine that terbacil can be used without resulting in
       unreasonable adverse effects to humans and the environment. The Agency, therefore,
       finds that all products containing  terbacil as  the active  ingredient are eligible for
       reregistration. The reregistration of particular products is addressed in Section V of this
       document.

             The Agency made its reregistration eligibility determination based upon  the target
       data base required for reregistration, the current guidelines for conducting acceptable
       studies to generate such data, published scientific literature, etc. and the data identified in
       Appendix B.  Although the Agency has found that all uses of terbacil are eligible for.
       reregistration, it should be understood that the Agency may take appropriate regulatory
       action,  and/or require the submission of additional data to support the  registration of
      products containing terbacil, if new information comes to the Agency's attention or if the
      data requirements for registration (or the guidelines for generating such data) change.

      B,     Determination of Eligibility Decision
             1.
Eligibility Decision
                    Based on the reviews of the generic data for the active ingredient terbacil,
             the Agency has sufficient information on the health effects of terbacil and on its
                                          77

-------
       potential for causing adverse effects in fish, wildlife, and the environment.  The
       Agency has determined that terbacil products, labeled and used as specified hi this
       Reregistration Eligibility Decision, will not pose unreasonable risks or adverse
       effects to humans or the environment.  Under the Food Quality Protection Act of
       1996, the Agency has determined that a reasonable certainty of no harm will result
       to infants  and children or to the general population from aggregate exposure to
       terbacil.  Therefore, the Agency concludes that products containing terbacil for all
       uses are eligible for reregistration.

       2.    Eligible and Ineligible Uses

             The Agency has determined  that all uses  of terbacil are eligible  for
       reregistration subject to conditions imposed hi this RED.

C.     Regulatory Position

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

       1.    Food Quality Protection Act Findings

             a.     Determination of Safety for U.S. Population

                    EPA has determined that the established tolerances for terbacil meet
             the safety standards under the FQPA amendments to section 408(b)(2)(D)
             for the general population.   In reaching this determination,  EPA has
             considered available information on aggregate exposures (both acute and
             chronic) from non-occupational sources, food and drinking water, as well
             as the possibility of cumulative effects from terbacil and other chemicals
             with a similar mechanism of toxicity.

                    Since there are no residential or lawn uses of terbacil, no dermal or
             inhalation exposure is expected in and around the home.

                    In assessing acute dietary risk from food, the endpoint selected was
             developmental toxicity.    Because  the endpoint  of concern  is  a
             developmental effect,  the only sub-population of concern is females of
             child-bearing age (i.e., females, 13+ years old).

                    In  assessing chronic dietary risk from food, EPA  estimates that
             terbacil residues in food account for 12.2  % of the RfD, based on existing
             tolerances and assuming  100% of the crop treated.   Incorporating the
             results of the Agency's  reregistration review (i.e., to revoke  tolerances for
                                    78

-------
 citrus fruits and pears, and to raise tolerances on caneberries, blueberries,
 peaches,  apples, and sugarcane),  4.5%  of the  RfD is  utilized  (using
 tolerance levels and assuming 100% crop treated).

        In assessing aggregate risk,  dietary exposures from food  and
 drinking water were considered.  Aggregate acute dietary risk for females
 of child-bearing age was calculated and the MOE=1563.  Acute dietary
 risk from food alone was calculated for females of child-bearing age and
 the MOE=4166, (based on tolerance level? reassessed in this RED  and
 100% crop treated).

        In  assessing aggregate chronic dietary risk, exposures from food
 and drinking water were considered.  The aggregate exposures account for
 27.6% of the RfD.

        In evaluating the potential for cumulative effects, EPA compared '
 terbacil with other structurally similar substituted uracil compounds, such
 as bromacil and lentacil, and then with other compounds producing similar
 effects.  A comparison of the available toxicological database for terbacil
 and bromacil revealed no clear common mode of toxicity for the chemicals.
 The toxicology database for lentacil was not considered because there are
 currently no registered uses of lentacil.  Based on the available data,  the
 Agency has determined that there is no clear common mode of toxicity
 between terbacil and bromacil.

 b.    Determination of Safety for Infants and Children

       EPA has determined that the established tolerances for terbacil meet
 the safety standard under the FQPA amendment to 'section 408(b)(2)(C)  for
 infants and children.  The safety determination for infants and children
 considers the factors noted above for the general population,  but also  takes
 into account the possibility of increased dietary exposure due to the specific
 consumption patterns of infants and children, as  well as the possibility of
 increased susceptibility to  the toxic effects of  terbacil residues ha this
 population subgroup.

       In determining whether or not infants and children are particularly
 susceptible to toxic  effects from terbacil residues, EPA considered the
 completeness of the database for developmental and reproductive effects,
the nature of the effects observed, and other information.

       Based  on  current data requirements, terbacil  has a complete
database for developmental  and reproductive  toxicity.   Because the
developmental NOELs were the same as those for maternal toxicity, and
                      79

-------
      the NOEL for systemic (parental) toxicity was higher than the NOEL for
      reproductive toxicity, these data do not suggest an increased pre- or post-
      natal  sensitivity  of  children  and  infants  to  terbacil  exposure.
      Therefore,EPA concludes that the available toxicology data do not support
      an uncertainty factor of 1000 as specified in FQPA and that the present
      uncertainty factor of 100 is adequate to ensure the protection of infants and
      children from exposure to terbacil.

             ,EPA estimates that  terbacil  residues in  the diet of infants and
      children account for 12.8% of the RfD  and residues in drinking water
      account for  81%  of the RfD.  Thus, the  aggregate exposure from all
      sources of terbacil account for 93.8% of the RfD.  Therefore, the Agency
      concludes that aggregate risks for infants and  children resulting from
      terbacil uses are not of concern.

              In deciding to continue to make reregistration determinations during
      early  stages of FQPA implementation, EPA recognizes that it will be
      necessary to make decisions relating to FQPA before the implementation
      process is complete.  In making these early, case-by-case decisions, EPA
      does not intend to set broad  precedents for the application of FQPA to its
      regulatory determinations. Rather, these early decisions will be made on
      a case-by-case basis and will not bind EPA as it proceeds with further
      policy development and any rulemaking that may be required.

              If EPA determines, as a result of this later implementation process,
      that any of the determinations described hi this RED are no  longer
      appropriate, the Agency will  consider itself free to pursue whatever action
      may be appropriate, including but not limited to reconsideration  of any
      portion of this RED.

2.    Tolerance Reassessment

      A summary of the  terbacil tolerance reassessment and recommended
modifications in commodity definitions is presented in Table 30.
       a.      Tolerances Listed Under 40 CFR §180.209(a)

              Sufficient data are  available to ascertain the adequacy  of the
       established tolerances on apples, peaches, and sugarcane. The tolerance on
       peaches should be increased to 0.2 ppm to reflect the combined limit of
       detection for terbacil and its three  regulated metabolites (each at 0.05
       ppm). Tolerances on apples and sugarcane should be increased to 0.3 ppm
       and 0.4 ppm, respectively,  based upon the available residue  data.  Data
                             80

-------
 from the apple processing study indicate that tolerances are not required for
 any regulated processed apple  commodity (i.e.,  apple juice  and wet
 pomace).  The tolerance on pears and citrus fruits  will be revoked since
 terbacil is no longer used on these commodities

 b.     Tolerances Listed Under 40 CFR §180.209(b)

        Sufficient data are  available to ascertain  the  adequacy of the
 established tolerances on caneberries, blueberries, alfalfa (forage and hay),
 asparagus, mint, and animal commodities.  The tolerance on caneberries
 and blueberries should be increased to 0.2 ppm to reflect the combined
 limit of detection for terbacil  and its three regulated metabolites (each at
 0.05 ppm).   Data from the mint processing studies also indicate that a
 tolerance is  not  required  for mint  oil (the only regulated  processed
 commodity of mint). Additional residue data are required for strawberries.

       The available data indicate that tolerances on alfalfa forage and hay
 should.be lowered from 5 ppm to 1 and 2 ppm, respectively, and that the
 tolerance on asparagus should be increased from 0.2 ppm to 0.4 ppm.

       The  Agency has determined that residues of terbacil  in animal
 commodities will be based on CFR part 180.6(a)(3). There is no likelihood
 of finite residues of terbacil hi animal commodities once  tolerances on
 alfalfa forage and hay are reduced to 1 and 2 ppm, respectively. Once the
 lower alfalfa tolerances are  established, terbacil tolerances on all animal
 commodities should be revoked.

       Tolerances on pecans,  and sainfoin should be revoked as uses on
these commodities have been canceled.
                      81

-------
Table 30: Tolerance Reassessment Summary for Terbacil
aa***w» „; . , /,;
<**»g*^
jkJSS^
S&^^U* f':~ '-', '
' , -- ^ " T«terattcesfisteatwaer4&CfB.^iaU09(a)*f
Apples
Citrus fruits
Peaches
Pears
Sugarcane
, , - °
Alfalfa, forage
Alfalfa, hay
Asparagus
Blueberries
Caneberries (blackberries,
boysenberries, dewberries,
loganberries, raspberries, and
youngberries)
Cattle, &t
Cattle, mbyp
Cattle, meat
Goat, fat
Goat, mbyp
Goat, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk, fat (=0.1 ppm in whole
milk)
Mint, hay, peppermint
Mint, hay, spearmint
Pecans
Sainfoin, forage
Sainfoin, hay
Sheep, fat
Sheep, mbyp
Sheep, meat
Strawberries
0.1
0.1
0.1
0.1
0.1
' TofejpaeeS
5.0
5.0
0.2
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 ,
0.1
0.5
2.0
2.0
0.1
5.0
5.0
0.1
0.1
0.1

0.3
Revoke
0.2
Revoke
0.4
feted tinder 40 CFK4;
1
2
0.4
0.2
0.2
Revoke
2
2
Revoke
Revoke
Revoke
TBD"
The available data indicate that the tolerance should be
increased.
No registered uses.
Tolerance should be increased as the combined LOD for
residues of concern is 0.2 ppm.
No registered uses.
The available data indicate that the tolerance should be
increased.
jSQJlf&ifSj'i ,
The available data support lowering the tolerances on
alfalfa forage and hay.
The available data indicate that the tolerance should be
increased.
If the required data indicate that residues are similar on
blueberries and caneberries. The registrant can propose a
single tolerance for the berries crop group, and separate
tolerances on blueberries and caneberries could be
revoked.
The Agency has determined that terbacil residues in
animal commodities will represent a 180.6(a)(3) situation
once tolerances on alfalfa forage and hay are reduced to 1
and 2 ppm, respectively. Once the lower alfalfa
tolerances are established, terbacil tolerances on all
animal commodities should be revoked.


No registered uses.
No registered uses.
See above comments under cattle.
IR-4 is supporting this use and is currently developing
residue data.
'Since the Agency is recommending that the tolerance expressions be unified to include Terbacil and Metabolites A,
B, and C, these two CFR sections should be combined at the time of tolerance reassessment.
"TBD = To be determined. Tolerance cannot be determined at this time because additional data are required.
                                                82

-------
        c.     Codex Harmonization

               No Codex Maximum Residue Limits (MRLs) have been established
        for terbacil for any agricultural commodity. Therefore, no compatibility
        questions exist with respect to U.S. tolerances.

 3.     Tolerance Revocations and Import Tolerances

        Several food/feed uses of terbacil have been voluntarily canceled  Once a
 pesticide use is no longer registered in the United States, the related pesticide
 residue  tolerance and/or food/feed  additive regulation generally is no longer
 needed.  It is EPA's policy to propose revocation of a tolerance, and/or food/feed
 additive regulation, following the deletion of a related food use from a registration
 or following the cancellation of a related food-use registration   EPA has the
 responsibility under the Federal Food, Drug, and Cosmetic Act (FFDCA) to
 revoke a tolerance/regulation on the grounds that the Agency cannot conclude-that
 the tolerance/regulation is protective of the public's health.

        The Agency recognizes/however, that interested parties may want to retain
 a tolerance and/or food/feed  additive  regulation in the absence  of a U S
 registration, to allow legal importation of food into the U.S. To assure that all
 food marketed in the U.S. is safe, under FFDCA, EPA requires the same technical
 chemistry and toxicology. data for such import tolerances (tolerances without
 related U.S. registrations) as are required to support U.S. food use registrations
 and any resulting tolerances. See 40 CFR Part 158 for EPA's data  requirements
 to support domestic use of a pesticide and establishment and maintenance of a
 tolerance and/or food/feed regulation.   In addition, EPA requires residue
 chemistry data (crop field trials) that are representative of growing  conditions in
 exporting countries in the same manner that EPA requires representative residue
 chemistry data from different U.S. regions to support domestic use of the pesticide
 and the tolerance and/or regulation. Additional guidance on the Agency's import
 tolerance  policy will be published in an upcoming Federal Register Notice.

       Parties interested in supporting an existing terbacil tolerance  as an import
 tolerance should ensure that all of the data noted above are available to EPA during
 its further assessments of existing tolerances and regulations, so that the Agency
 may determine whether maintenance of the tolerance and/or regulation would be
 protective of the public's health.

4.     Ecological Effects

       Minimal adverse acute effects are expected for avian, mammalian and
aquatic species from labeled uses of terbacil. Chronic effects for avian and "aquatic
species cannot be evaluated at this time because of  insufficient data   However
                             83

-------
chronic RQs for mammals indicate that adverse effects are possible from labeled
uses  of terbacil.   There  is  some  uncertainty in assessing  adverse chronic
mammalian effects because the NOEL is greater than the maximum concentration
tested in rat reproduction study design.  Therefore, the highest concentration is a
default toxicity endpoint which is a conservative estimate of risk.   Since terbacil
is a persistent and mobile herbicide,  non-target terrestrial plants are expected to
be adversely affected from runoff and spray drift.  Minimal adverse effects,
however, are expected for non-target aquatic plants^  Because terbacil is used
exclusively on minor crops, terbacil exposure is expected to be very localized and
dependent on site specific conditions. The localized nature of terbacil use areas is
expected to limit human and ecological exposure.

5.     Endangered Species Statement

       The Agency has developed a program (the "Endangered Species Protection
Program") to identify  pesticides  whose use may cause adverse impacts on
endangered and threatened species, and to implement mitigation measures that will
eliminate the adverse impacts.  At present, the program is being implemented on
an interim basis as described in a Federal Register Notice (54 FR 27984-28008,
July 3,1989), and is providing information to pesticide users to help them protect
these species on a voluntary basis.  As currently planned, the final program will
call for label modifications referring to required limitations on pesticide uses,,
typically  as  depicted  ha county-specific  bulletins or by other site-specific
mechanisms as specified by state partners. A  final program, which may be altered
from the interim program, will be described hi a future  Federal Register Notice.
The Agency is not imposing label modifications at this time through the  RED.
Rather, any requirements for product use modifications will occur hi the  future
under the Endangered Species Protection Program.
6.
Surface Water
       The Agency recommends a surface water label advisory on terbacil because
it has characteristics (persistent and very mobile) of pesticides (e.g. atrazine, etc.)
hi surface waters. Surface water modeling for a Louisiana sugarcane scenario
indicate terbacil may accumulate at concentrations greater than 1 mg/L.  Since
terbacil is used on vulnerable soils for surface water contamination such as the
Louisiana production area, a surface water label advisory is required. The label
advisory must state:  "Terbacil has properties that may result in surface water
contamination via dissolved  runoff  and runoff erosion.   Practices should be
followed to minimize the potential for dissolved runoff and/or runoff erosion."
7.
Ground Water
       Terbacil is more mobile and persistent than a number of herbicides which
have been found to contaminate ground water. EPA recommended a ground water
label advisory be placed on the terbacil label hi 1989 and in 1995.  The Agency

                             84

-------
continues to  recommend a ground water label advisory.  The following label
language  is  appropriate:   "This chemical has properties  and characteristics
associated with chemicals detected in ground water.  The use of this chemical in
areas where  soils are permeable, particularly where the water table is shallow,
may result in ground-water contamination."

       Ground and surface water monitoring studies for terbacil are not considered
necessary at this time and are placed in reserve.  If terbacil .use should expand in
the future or the use pattern changes significantly, a small-scale prospective study
or a limited monitoring program may become necessary.  Additionally, a surface
water monitoring program may be needed with  expanded use on major crops.

8.     Occupational Labeling Rationale/Risk Mitigation

       a.     The Worker Protection Standard (WPS)

             The 1992 Worker Protection Standard for Agricultural Pesticides
       (WPS) established  certain worker-protection  requirements (personal
       protective equipment, restricted entry intervals, etc.) to be specified on the
       label of all products that contain uses within the scope of the WPS. Uses
       within the scope of the WPS include all commercial (non-homeowner) and
       research uses on farms,  forests, nurseries, and greenhouses to  produce
       agricultural plants (including food, feed, fiber plants, trees, turfgrass,
       flowers,  shrubs, ornamentals, and seedlings).  Uses within scope include
       not only uses on plants, but also uses on the soil or planting medium the
     ' plants  are (or will be) grown in.

             All currently registered uses of terbacil are within the scope of the
      Worker Protection Standard for Agricultural Pesticides.

      b.     Personal  Protective  Equipment/Engineering  Controls for
             Handlers

             (1)    Occupational-Use Products

                   For  each   end-use  product,  PPE/engineering  control
             requirements for pesticide handlers will be set during reregistration
             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 oh the acute toxicity of the end-use product. For
                   occupational-use products, PPE will be established using the
                            85

-------
c.
       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  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 or
              engineering-control requirements that pertain to all
              or most occupational 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 each 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.

       The  Agency has determined that there  are no  special
lexicological concerns about terbacil to warrant the establishment
of   active-ingredient-based  handler   PPE/engineering-control
requirements. Handler PPE requirements for terbacil products are
to be based on the  acute toxicity of individual end-use products.

(2)     Homeowner Use Products

       There are no homeowner uses registered for terbacil.

Post-Application/Entry Restrictions

(1)     Restricted Entry Interval

       Under the  Worker Protection Standard  (WPS),  interim
restricted entry intervals(REIs) for all uses within the scope of the
WPS are based on  the acute toxicity of the active  ingredient.  The
toxicity categories of the active ingredient for acute dermal toxicity,
eye irritation potential, and skin irritation potential are  used to
                      86

-------
 determine the interim WPS REI.  If one or more of the three acute
 toxicity effects are in toxicity category I, the interim WPS REI is
 established at 48 hours. If none of the acute toxicity effects are in
 category I, but one or more of the three is classified as  category II,
 the interim WPS REI is established at 24 hours.  If  none of the
 three acute toxicity effects are in category I or H, the interim WPS
 REI is established at 12 hours. A 48-hour REI is increased to 72
 hours when an organophosphate pesticide is  applied outdoors in arid
 areas. In addition, the WPS specifically retains two types of REIs
 established by the Agency prior to the promulgation of the WPS:
 (1) product-specific REIs established on the basis of adequate  data,
 and  (2) interim REIs that are longer than  those that would be
 established under the WPS.                 .
                        i      •

       The interim WPS REI in effect until  now for occupational
 use products that contain terbacil and are  within the scppe of the
 WPS is 12 hours. During the reregistration process EPA found no
 reason to lengthen the previously established REI.

 (2)    Early Entry PPE

       The WPS establishes very specific restrictions on entry by
 workers to areas that remain under a restricted-entry interval if the
 entry involves  contact with treated surfaces.  Among those
 restrictions are a prohibition of routine entry to perform hand labor
 tasks and the requirement that personal protective equipment be
 worn.   Personal protective equipment requirements for persons
 who must enter areas that remain under a restricted-entry interval
 are based on the toxicity concerns about the active ingredient. The
 requirements are set in one of two ways.
1.
2.
If EPA determines that no regulatory action muk be taken
as the result of the acute or other adverse effects  of an
active  ingredient, it  establishes  the  early-entry  PPE
requirements on the basis of the acute dermal toxicity, skin
irritation potential, and eye irritation potential of the active
ingredient.

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),  it.  may establish early-entry PPE
                87

-------
                    d.
       requirements that are  more  stringent than  would  be
       established otherwise.

       Terbacil is classified as  category IV for acute oral, acute
dermal and dermal irritation, and category III for acute inhalation
toxicity and  for  eye irritation.  EPA  has determined that  no
regulatory action must be taken due to acute effects or other adverse
effects of terbacil.  Therefore the PPE required for early entry is the
rninimum early-entry PPE permitted under the WPS: coveralls,
chemical-resistant gloves, shoes  and socks.

(3)    WPS Double Notification Statement

       The WPS double notification requirement is imposed if the
active ingredient is classified as toxicity category I for acute dermal
toxicity  or skin  irritation potential.    Since neither of these
classifications apply to terbacil, double notification is not required
for terbacil end-use  products.

(4)    Entry Restrictions for Occupational-Use Products (Non-
       WPS Uses)

       There are no non-WPS uses registered for terbacil.

Other Labeling Requirements
                           For the specific labeling statements, refer to Section V of this
                    document.

             9.     Spray Drift Advisory

                    The Agency has been working with the Spray Drift Task Force,  EPA
             Regional Offices and State Lead Agencies for pesticide regulation to develop the
             best spray drift management practices.  The Agency is now requiring interim
             measures that must be placed on product labels/labeling as specified in Section V.
             Once the Agency completes its evaluation of the new data base submitted by the
             Spray Drift Task Force, a membership of U.S. pesticide registrants, the Agency
             may impose further refinements in spray drift management practices to further
             reduce off-target drift and risks associated with this drift.
V.     ACTIONS REQUIRED OF REGISTRANTS

       This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
                                          88

-------
A.     Manufacturing-Use Products

       ,1.     Additional Generic Data Requirements

             The generic data base)supporting the reregistration of terbacil for the above
       eligible uses has been reviewed and determined to be substantially complete.  The
       following studies are required to be conducted on the generic active ingredient.

                    Aerobic Aquatic Metabolism [162-4]
                    Avian Reproduction Quail [71-4(a)J   -
                    Avian Reproduction Duck [71-4(b)]
                    Early Life-Stage Fish [72-4(a)]
                    Life-Cycle Aquatic Invertebrate [72-4(b)]

      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 herbicide for the following use(s) [terrestrial
             food/feed crops (e.g., apples, mint/peppermint,  and sugarcane), forestry
             (e.g., cottonwood (forest/shelterbelt), terrestrial food (e.g., asparagus,
             blackberry,  boysenberry, dewberry, loganberry,  peach,  raspberry'
             youngberry and strawberry), and terrestrial feed (e.g., alfalfa, sainfoin
             (hay and fodder), and forage)] being supported by MP registrant."

             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,
                  user group, or grower  has  complied with  U.S. EPA
                  submission requirements regarding 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  support of such
                  use(s)."                                               ,

            Other labeling requirements include:
                                  89

-------
                     (a)     Maximum  label  application  rates  should  be  reduced  to be
                            representative of typical application rates.  Table 31 below lists
                            typical terbacil application rates.
Table 31; Typical Terbacil Use Rates
, *',ZJrv> /- < '.
•, 1*,,*&',',':\ '0*8^' - '- „„ ~i
, - ~r«< *,*-;*-,- , <;..;% , ; ',' ' \
Alfalfa-Application by Air as well as ground
U.S.
NEU.S.
SLN'S: (PA, VA)
(WA, OR) Seedling Alfalfa
(NM) Aerial Use
(OK)
Supplemental Aerial Use
Apples, Peaches-Broadcast and Banded
Asparagus-Broadcast
Blueberries-Broadcast and Banded; Ground Only
Caneberries-Broadcast, Ground Only
Mint-Ground and Air0
Sugarcane-Broadcast and Banded,
Ground and Air1
(LA)
CTX)
(HI)
(PR)
Strawberries-Banded, Ground Only; Recommended by
Supplemental Label Only
Hybrid Poplars-Banded Ground Only
SLN'S: (OR, WA)
Grass Seed-Broadcast; Ground Only; Forage Restriction
SLN (ID)
SLN (OR)
SLN (WA-East of Cascades)
; tfeeltafe
'"Mwfowm "\

1 1/2 LB/A/YR
2 1/4 LB/A/YR
1/2 LB/A/YR
1 1/2 LB/A/YR
1 1/2 LB/A/YR
2 1/4 LB/A/YR
1 1/2 LB/A
4 LB/A/YR
3 LB/A/YR
4 LB/A/YR
2 LB/A/YR
2 LB/A/YR

4 LB/A/YR
4 LB/A/YR
2 1/2 LB/A
2 1/2 LB/A
l/21b/A

2 LB/A

1LB/A
1 1/4 LB/A/YR
1 LB/A/YR
typteH.

1 to 1 1/2
11/2
1/2 LB
1 1/2 LB
11/2LB
1 1/2-2 LB
1 1/2
2-4'
1.5-2.5"
2-3 LB
2LB
2LB

1 1/2-
24/10
1-2 LB
1-2 1/2 LB
1-2 1/2 LB
1/2 LB

2LB

1LB
1 1/4 LB
1LB
'%PJw8tl
-------
                    should be followed to minimize .the potential for dissolved runoff
                    and/or runoff erosion."

              (c)    '"This chemical has properties and characteristics associated with
                    chemicals detected in ground water.  The use of this chemical in
                    areas where soils are permeable, particularly where the water table
                    is shallow, may result in ground-water contamination."

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.  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.     PPE/Engineering Control Requirements for Pesticide Handlers

             For  sole-active-ingredient end-use products that contain terbacil,  the
      product  labeling must be revised  to  adopt the handler personal protective
   *   equipment 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 terbacil, the
      handler personal protective equipment requirements set forth in this section must
      be compared to the requirements on the current labeling and the more protective
      must be retained.  For guidance on which requirements  are considered more
      protective, see PR Notice 93-7.

             a.     Minimum PPE/Engineering Control Requirements

                   EPA  is  not  establishing  active  ingredient-specific  PPE  or
            engineering control requirements for terbacil end-use products.

            b.     Actual end-use product PPE requirements

                   Any necessary PPE for each terbacil occupational end-use product
            will be established on the basis of the end-use product's acute toxicity
            category.
                                  91,

-------
       c.     Placement in labeling

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

3.     Entry Restrictions

       For sole-active-ingredient end-oise products that contain terbacil 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.
                                                i         \
       For multiple-active-ingredient end-use products that contain terbacil the
entry restrictions set forth in this section must be compared to the entry restrictions
on the current labeling and the more protective must be retained. A specific time-
period in hours or days is considered more protective than "sprays have dried" or
"dusts have settled."

       a.     Restricted-entry interval

             A 12-hour restricted-entry interval (REI) is required for uses within
       the scope of the WPS on all terbacil end-use products.

       b.     Early-entry personal protective equipment (PPE)

             The PPE required for early entry to treated areas that is permitted
       under the Worker Protection  Standard arid  that involves contact with
       anything that has been treated, such as plants, soil, or water, is:

             Coveralls over short-sleeve shirt and short pants
             Chemical-resistant gloves
             Shoes and socks

       c.     Placement in labeling

             The REI  must be inserted into the standardized REI statement
       required by Supplement Three of PR Notice 93-7. The PPE required for
       early  entry must  be  inserted into  the standardized early-entry  PPE
       statement required by Supplement Three of PR Notice 93-7.

4.     Spray Drift Labeling

       The following aerial drift reduction advisory information must be contained
in the product labeling:

                             92

-------
                      AERIAL SPRAY DRIFT MANAGEMUCT


                  Drift at the Application Site js €he Responsibility of the Applicator,

The interaction qf sway eq^tae»t-and-weatfeeT-i»lated factors detgrjuia& tie' potential' for spray
drift.  The applicator is responsible for considering all these factors when making decisions.
     ,'"'     " ,«      •>    ^                    '" w'     ,      s           ^  '
The following dri& management abatements must be followed to avoid off-targei movement
from'aerial applcations to agricultural field crops.  These regmrements do not apply to forestry
          =,-publicnealth^ses or to—«—-«--'-   *    <        - •
      the distaape of fh^oitfer most Rozzjies oa the boom nmst not exceed 3/4 the leagth &£ the
               or rotor.   '      % i- -                ^                   — -
                       ys pbmt bacfewad parallel with ike air streasa and never' be poimed
                 more ffcam 45 degrees    '\      %       ^            "
Where slates nave
                                         ^
                                                                   '
         e applicator snoidd be familkr with and-tate kto'accoaat the'informatioii covered in.
      the- Aeiial Drilt Rectedfoa Advisory^ ,      -  -               '.. -   ,
            5.    . Other Labeling Requirements

                   The Agency is requiring the following labeling statements to be located on
            all end-use products containing terbacil 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."

                   User Safety Requirements:


                   "Discard  clothing or other absorbent materials that have been
                   drenched or heavily contaminated with this product's concentrate.
                   Do  not reuse  them.  Follow manufacturer's  instructions  for
                   cleanmg/maintaining PPE. If no such instructions for washables,
                                        93

-------
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.
       As soon as possible,  wash thoroughly and change into  clean
       clothing."

Engineering Controls:

"When handlers use closed systems, or .enclosed cabs or  aircraft in a
manner that meets the requirements listed  in the Worker Protection
Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the
handler PPE requirements may be reduced or modified as specified in the
WPS."

INFORMATION ON DROPLET SIZE

The most effective way to reduce drift  potential is to apply large droplets.
The best drift management strategy is to apply the largest  droplets that
provide sufficient coverage and control. Applying larger droplets reduces
drift potential, but will not  prevent  drift  if applications  are  made
improperly,  or under unfavorable environmental conditions (see Wind,
Temperature and Humidity, and Temperature Inversions).

CONTROLLING DROPLET SIZE

•      Volume - Use high flow rate nozzles to apply the highest practical
spray volume. Nozzles with higher rated flows produce larger droplets.

•      Pressure - Do not exceed the nozzle manufacturer's recommended
pressures. For many nozzle types lower pressure produces larger droplets.
When higher flow rates are needed, use higher flow rate nozzles instead of
increasing pressure.

•      Number of nozzles - Use the minimum number of nozzles that
provide uniform coverage.
                      94

-------
  •     Nozzle Orientation - Orienting nozzles so that the spray is released
  parallel to the airstream produces larger droplets than other orientations
  and is the recommended practice.  Significant deflection from horizontal
  will reduce droplet size and increase drift potential.

  •     Nozzle Type - Use a nozzle type that is designed for the intended
  application. With most nozzle types, narrower spray angles produce larger
  droplets. Consider using low-drift nozzles.  Solid stream nozzles oriented
  straight back produce the largest droplets and the lowest drift.

 BOOM LENGTH

 For some use patterns, reducing the effective boom length to less than 3/4
 of the wingspan or rotor length may further reduce drift without reducing
 swath width.

 APPLICATION HEIGHT

 Applications should not be made at a height greater than 10 feet above the
 top  of the largest plants unless a greater height is  required for aircraft
 safety.  Making applications  at the lowest height  that is  safe reduces
 exposure of droplets to evaporation and wind.

 SWATH ADJUSTMENT

 When applications are made with a crosswind, the swath will be displaced
 downward.  Therefore, on the up and downwind edges of the field, the
 applicator must compensate for this displacement by  adjusting the path of
 the  aircraft upwind.  Swath adjustment distance should increase,  with
 increasing drift potential (higher wind, smaller drops, etc.)

 WIND

 Drift potential is lowest between wind speeds of 2-10 mph. However,
 many factors, including droplet size  and equipment  type determine  drift
 potential at any given speed.  Application should be avoided below 2  mph
 due to variable wind direction and high inversion potential. NOTE:  Local
 terrain can influence wind patterns.  Every applicator should be familiar
 with local wind patterns and how they affect spray drift.

 TEMPERATURE AND HUMIDITY

When making applications in low relative humidity,  set up equipment to
produce  larger  droplets to compensate for  evaporation.   Droplet
evaporation is most severe when conditions are both hot and dry.

                      95

-------
      TEMPERATURE INVERSIONS

      Applications should not occur during a temperature inversion because drift
      potential is high.  Temperature inversions restrict vertical air mixing,
      which causes small suspended droplets to remain in a concentrated cloud.
      This cloud can move in unpredictable directions due to the light variable
      winds  common  during  inversions.    Temperature   inversions  are
      characterized by increasing temperatures with altitude and are common on
      nights with limited cloud cover and light to no wind.  They begin to form
      as the sun sets and often continue into the morning.  Their presence can be
      indicated by ground fog;  however, if fog is not present, inversions can also
      be identified by the movement of smoke from a ground source  or an
      aircraft smoke generator.  Smoke that layers and moves laterally in  a
      concentrated cloud (under low wind conditions) indicates an inversion,
      while smoke that  moves  upward and rapidly dissipates indicates good
      vertical air mixing.

      SENSITIVE AREAS

      The pesticide should only be applied when the potential for drift to adjacent
      sensitive areas (e.g. residential areas, bodies of water, known habitat for
      threatened or endangered species, non-target crops) is minimal (e.g. when
      wind is blowing away from the sensitive areas).

6.    Existing Stocks

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

             The Agency has determined that registrants may distribute and sell
      terbacil products bearing old labels/labeling for 26 months from the date
      of issuance of this RED.  Persons other than 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 stock
      requirements applicable to products they sell or distribute.
                            96

-------
VI. APPENDICES
      97

-------
CO
§































_
I
1

i
















r-
o


p

1
Date: 03/08/91
Dates 07/02/96
C AJ
3 tJ

14 S

|1


















































CJ
U

"9

£
o
TM
O


(Tfitbacill Chemic


0
&

!
S w
O E 13

S J 0
So
-H
«2 "a
5-2
|Q
•5
"
O
I
u


tS i

a


>i •
u >
1 JJ *J

<:§£

w2


*** Tl " *
— ,g$^
e o "o"
w c w

jllsU
£ 3 O*-, O
w ® i-i
1st

J3 o >i
Jg tSf N^, (J
•-4 * - ID
•H X x n
to HaES
• H T» «~-
•S.SSJ
%g cl
x S a S
£ .2 o
3
e
• 3 T3 «
r-4 €> 8>
OiH W n
J| 85

t ,
o « •—
Eu O >i
*M c

"rH
C 1 "S*0
O <-t W
•H CO

^ I « OJ
cation Type, Appl
Application Equip
Type (Antindccobi
encing Factor (An
•H 3
r-l <*&>-<

K tj *"*
u — i 3 >i
to


























































1
£

CO
W
I
1
CO
u u
3 §
1— <
3 Q
S S
W lu
-%»
co a
H Q
CO O
go o
o o


o o o



fO
»-f
0
H CO CO
Z <0 Z 25

cu ^


O XI W CO CO
Q -i 3 Z Z
Cd CO *J
d ^
a
E^ CO •• CO CO
1 zs a z

ce ^
Id O
H CM OJ CO CO
3* &y O IM O Cu O
S


rH CM CM





< < <
Z 25 Z
-

g g |5





i-l

M
i i
Su
o
4-? JJ
C C
1 g


to n
< (0 <0
111

J U M
o o


^t *a<
O . O

o
o
<**> n
1-) TH
o o
0 0
CO - CO
s s
ns ' (0
JJ JJ
W W
J-l U
 to CO
CD Z Z CD Z 25
Itr O bO * •** ta O + *

22 22 S 2 22 S S

T-t tH





< «: «:«<<< < <
z *. z z a 22


S Is ' S S S ' is S


TJ
O U O O-
CQ O O ti
CQ O
O O ' -p" 4J~
C C (0 10
a) CP o» > >
>i W J-t J-l H
CO -P -P iH i-I
w w ret id
- o o c c
-p a a -H -H
C «w -• i 13 T3 >. 13

SO U O O W O
i-i Q. H M CU • U
CQ CQ W CQ CQ CO CQ
0
^

O '

o
0
s
0
o
CO
s
(0
JJ
CO

s
c
*^ H

0
X!
x: JJ
D
CO CO to CM O
•H
W CO O CO C
s R *° z i2
CO CO CO tO rH
Z Z 25 2 ffl
O
^

0>
to co xi co w
^ °
s
CO CO CO tO "
222 23
o
o
CO CO CM tH t O

O , W .1-1
' a <
*• to
o •»
O *. 0)
C JJ o
CD CO C
& CD (D
U > CP
III
CO CQ d)
O O U
Oi GJ Oj

JJ JJ 4J
w to u
• O CJ O
•0 -O TJ

O O O
i-t W J-l
CQ CQ CQ
oo

-------




























1
QJ
W .
tC
X
M
Q
Cu
3
















rH '
•H
0
1
M
••£
TH
O
t—
CM
iH
O
. »H
•acil] .Chemica
0}
EH

CO
0
O-
0)
W
3

W
• §
•H
JJ
••d flj
W -H O
& J O

•o f
S5
0 rH
•H (0
JJ W
-g °.
•H
O
fl
CD 'O
rH



1 JJ 4J '
(U C C
CC CO |H
> —
c o ^
w —
w u
^- o •$ S^
3) o "aT """* -
§c to
«H
n u ft a)
•  fl)
ftM JJ W
-X< O -H
< — G S
• fl) W 41
C JJ to J3
3 (0 4) JJ

2-
3 i
0 rf -.
c« u >,
•H r-t
: >t-l O
• u
C ] >i 0
O rH M
H CO
J 0) rH 'r4
m Type, Appli.
cation Equipm
(Antimicrobia.
g Factor _ (Ant;
O -r-( C
1 rH Q) -H

rH ». fl> rH .
., D> O f-i
ji C (0 C
'E-< CO O














,








































3
H
3
0
li
o
I 1
H
USES ELIG
FOOD/ FEED

:' -8 ',8
•8 1
u>" UD"
'* ""3"
00


rH

O
3 ' rH
0 0



iH
O
O
'A JS
CM CM

CQ O
i?
G CO to
^"
Oj
§'
•
O CO 0) J2 J CJ O)
< ' CO CO
E^ co •• CO ••
CO 3 CO SS CO
63 rH rH
QJ O O,
W O O
£-" iH 








< <
sz &


g .g
^
[s,
2
Q. M
S 1
1 CO W
. » 6
S §
§ m
tn »
U 0)
O ~ rH
c a «.
8
— jj jj
01 (0
•< « , (0
tw O o
J TJ • *0
tu- 0 0
.J M Lj
< CQ CQ
























Ai
O
Q,

g
g
2
OS'
E*
to
u

1

&
o
5

s




















1
g
-8 •
1


0













B
TH

.g

CO



CO

u
•*•».
rH


tw S O

< •< <
rHrH rH
CM co ^r








jj
s


g
*j
S
§•
O
CQ
Postharvest,
c

0)
u
jj
•g
to
CQ
\D VO ,
§CQ
o
O
z> • t?
,0 S


0 . U













.fi j.:
CM , CM
rH rH

CO CO
• 21 ^

CO .CO



g §.


rH rH
*"»«. ^^

to co •

tu S O fti 2 o

•< rtj r< (<><)<
555 555
CM CO ^T CM CO ^P








J ' J
K ^


g g
R
tl Q.
Q) CO
S -|
a o •
VI 03
0 JJ •
s s
>
*• JH
& (S
.5 £
u ra
CO Oi
1 ' 2
€ a
.5 M
CD T3
" tj
1 2
ra ^-t
tO Q
s
I I 8
* ' •« X
3 so
g g~ g_
10 en


O O § O X













•C J5 .C
' CM ' ' CN CM
tH rf
g ' g g

g ' g g

CU
Q
a;
Cu CM
M •' 3 u * '
&• g .t4 R
rH TO rH rH

rH CC CM rH
CO E-< CO CO
- B ^
CtiSO 3 tuO CuO
O
14
rtjrtjrtj U <.< ii >i J-(
2 2 §,
o. a co
I ' §•' *•
» .-s§
0 £ ' &
1 a 1
CO «J ^H
- r • S *
>i W W
(o O O
ft '°*
W *
•o § -S S-
5 §• g g •
o 2 -o -M
0> < to S
u cu o o -
•H CO M M
Q < m o

0
1-


o s:













a
CM
*^
CO

g



rH
-CM

T-J

CM
m
s:
tu O

< <
A'rQ
•H .—1
CM iH








g
-

g

1 '
1
ergence, Boom
§
0)

Broadcast,
O^

-------
o
^r
CO
*3
"



































r*
0
S
1
ti
aU3
0%
*•*•••*
O O
ss
rt A
cS 3

U C
Is
II


















(-.
g
5


*
i
i











3

1
H
Chemical 01270
£4
1
©
H

0
6}
1
1
ft
JJ
*d °
Sj -rl *§
O »4 O

•o
G «-«
r
u
•H
ill
• w n
C i> >!

H~
S^-ffl
~ jj^.^1
fll O 'S
Q «°S
• So S"rf



|.S a
-«,
l!II
r-l • • O
—1 X S£ W
O J» ,S 5
w ^2 a
- w-a «

t*— 5 «
S =1
3 ®
• P "O -•-
i-i e o
. o n (t>
C -U « |j
a *"
1 s,~

SI
id
M» IS
>e, Application
in Equipment —
.Microbial only]
:tor (Antimicrob
U« W •*•! W
-H JH ffl -H

!*?!

^"lu"
12 S 3 o1
H









































SREGISTRATION
't)
2 g
S "

•J CO
S ^
5 o
H U
^.
in Q
w o
8888 8
3- 3- §„ g« S
Oo oo Oo Oo o
p- r- P- t-*
\D"T-| U?rH 
01 CM
i s
O w to co co o co
•z. z a a z

S li


a >, >, > s, s a
CO *H «H *H tH CO iH
S C£
E^ CO CO CO CO E* CO
2222 2
tOi
'CuO fiuO EuO IuO 3 tj 2 O
O
O O

(D  O* £
. 0 >i C 0
EQ flj -H E O
LI u o oa
t? w w to
C 4J*
U O rH i-t 0)
W EQ <8 RJ Li
bJ fet (0
>i J=
S tS § S S
c c Q) a> c
(S nJ AJ JJ (0
0) Q) (0 (0 0)
U LI (0 Lt (0 U
4J 4J O 1) U 4-9
>* -o >i -a
a: c c OLIO a: c
S >, >i CQ >>

2 OQ, o oo o ai iJ ,o a
ea cota co coco coto ca coco
8 '
I

10

O




?!

CO
2
CO
2


CO
2




£
tH
rH
CO
2
IuSO


,Q J3 JQ
1
pi
s^
A
CT
C
O.
CO
C
CO
0)
Li
JJ
•c
C
(0
•H
O
CO
8
1 •

W?

o




CM
r-C

CO
2
CO
2


CO
2




J-l
TH
rH
CO
2
tu S O
•< •< <

.0 ja ja
CM CM **





3

g

4J~
W
^nent, Postharve
0
4J

 U) rH

O OK




CM • CM
tH . rH

CO CO
2 2
CO CO
2 2
CU
i
CO O W
S 9, *
g

tJ
**
rH CO tH
-v. W *v.
tH CC rH
g ^ §
a
o
«; < < rfj «;
0)

CM CM -T VD CO





2 2

g g
g
O O
O CO
CO
1.' 1
>.
- rH
1 " 1
0) C
iJ «
CO (U
g ». a
•c P:
(0 EC T3
S u ra m n

•H M >< -H Li
O fl. O O O,
CO W (5 CO •
(C
u
&
o
CQ
rH
(0
Eii
C

OJ
Ll
•o
C!
(0
•H
O
CO
O
o

-------
88     8     8
co
g













































r^
0
m ,

1
1
t— «>
en en
-s. -"^
CO CM
o o
*-s. "-^.
o\ r-
o o
sl
ss
C 4J
ss
«§•
U K
8.0
0) IX
(X Cti
























§'
3

'PENDIX A
P4
<
















•H
0
rtj
•S
£

o
t—
CM
tH
0
rH
«
O

_g
O

Case 0039 ETerbacil
ra
1. -P CO
-g 0)
W -H ' O ,
*s
0} O
C rH
O rH
4J 0}
•H
i-q
0
x:
iH
o  ^
• J-J W
".H -W m
S CJ TJ
M —
H M ,
Q> O "3""*^
CO C CQ ,
Q to "3!
W & G, Q)
- ,
X Q, 0)
rH • • fl)
•H X X «•
O  U
• « CQ  -H
a
w
• S

IP
• I

BOYSENBERRY (con't)
Soil broadcast treal
Boom sprayer
S|
si













J3~
CM
rH


CO

g.


CO


TH
CO
Pw O

«
55
\O CO










g ..
g'


£
!
rH
rH,
(0
Eu

4J
1
R
Soil broadcast treat
sprayer






















0
§
o
Q
8

IRESTRIAL
S
§•
o

o
<1>






















DEWBERRY
^s
. si













x;
CM


CO

g


g


g,
TH
TH
tQ
2
CM U

«
X) XI

VD CD ^O CO
tH rH









g^ • g
g g'

t?
•H g
u o
Q. 0
CO 03
~H r-J
H Cu

•P p

g i 3 .
Soil broadcast treat
Boom sprayer
Soil broadcast treat
sprayer
GRASS FORAGE/ FODDER/
s.
'•V
o





' x.





Q
w

S
2

CO

g


§


w
g
fa S o

'
XI XI XI
03 (£1 VD
-









'^
g '


i_i

-------
I
ss
S3
 Ju

 I
us
UC£


i
gll
» -a o
O rH
S3
t
3
O
|
11
' a
*T>
kss
• Ll t»
5S&
;s c-o
w *-
S — «

*"* S «^
O O ffl
I w?
« LI (X O
il o£ &
n e u
III
~l §•"
X £ Lt O

£ CW-s. U
rH - • O
•rl X X W
S£S S
• M *O —»
•ft— .8 n
•^2^1
is|l
t
• o n o
c " " 5
* "°
U O <3 "
ffl tw 0 >i
1 SI


4) ffl

O — • .Q
r- c i >o
Ol O rH Ll
s 1^§i
r-4 U » rH -5
S-H 1 ffl •*•»
rH O.-H C
•H a, ft a *C


§ .^.So1
o c B i>
— 5. o~< o
Cj £**J e EM
I gj~c?
jj *>H rH 6) >r4
£ Jill
Cft rH •. ffl rH
U £-. E" « U
ffl M
O to














































|

CO
(_|

U
cc c
o
p *•*

s 1
USES ELIG:
FOOD/ FEED

CQ CQ
8O ,
y
W rH U> rH
^P o •* O
OK OS







43 JB
CM CM
rH rH
g g

4J
g g g
O

0*
g
O co to
8
tu
<
CO rH rH
C| rH rH
E-« CO CO
z z
p Cu O Cu U
»< < rtj »<
S JQXJ ja ja
10 CO U> CO
rH rH


< <:
z 2
^ §:
£ Ll
O 01
o >•
CQ ffl
Ll
•» a
n> tn
•S i
O* O
e) CQ

Li rH
W Cu

" Jj ^
O ffl ffl
U O 0)
- i! 3
1 "n 1
< rH ffl rH
O ML) fH
o o a o
i-1 CO W CO

CQ
8
ID rH
^" O
U SC







X
CM
rH
g


CO



g



rH


Z
fau
rtj rtj
JD X)
VD CO
rH


^
*
.



•H
Lt


%
cd
Cd


C
S
Ll
**
JJ
(0
ffl Ll
82
S&
•H O
O O
CO CQ

CQ
8
t—
l£* rH
^« o
(J W







j.
CSJ
rH
g


g .



g



rH

CO
Z
tu O
*< <;
&&
wco
rH


^
*
i





O
CQ
i-H
rH



g
U
*J
JJ
1
Soil broa'
sprayer

CO*
8
U> rH
o as







j=
CM
T-l
g


Oi CO
p
0
Id
+ rH
SU>
-

<
o:
EH CO
1 2
g

^
S1 In O
o
s
<«:
S ax*
CM CO
rH


,„*
'
>

kl


n)
' LI
a
m
o
CO

Z 0)
H 0
CU Q)
&J 4J

1 S
hCNT/PEPP;
Broadcast

cct
8
h
*f O
9 s







£1 '
CM
rH
to
Z


g.



rH
»
rH

CO
Z

rH

Cu O
i< rtj
XI JQ
VO CO
rH


^
Z
.•







<4H
Ll
O
Ll
•H


U
1
g
Q)
D
Oi
Broadcast

CO*
8
!i
O S3







j-
CM
rH
CO
Z


g



J2
i-H
">
rH

CO

rH

Cu O
< "C
.a ja
^co
rH


<
Z
1


Ll
Q)


Lt
ffl
5
8
Cu
^
JJ
I
(0
0)
Ll
JJ
TJ
C
ffl
CQ
3
ca
o
o
1
3







x:
CM
rH'
g


g



Z



rH

CO
Z .
Cu S CJ
< t

Ll




O
CQ
Jj"
n
o
>
Ll
ffl
£
8
Cu
*.

I
VI
Directed ;

-------
                                                                                         O    O
                                                                                         O  ,  0
oS
=>       =>.      s>
S s    S s   S s
                                                                                         8
-8    8
 I    I
                                        o §    ox"  os   '-o :
                                                                                              £
                                                                                              S
                                                                                        J=    45
                                                                                        CM    CM
                                                                 >i
                                                                S
                                                                                                                                                                             en
                                                                                                                                                                             O
                                               S
                                               fa u
               z
               Iw CJ
                     OJ CO ^3*          CO    tfl CO
                                                    •H f-f    rH rH
                                                    CM CO    CM CO
                                                                                                     g.      g    g
§    -
2    ~

-------
3


















g
1
3
o
g

9!







.


rH
jg
p* 4)

U)

1 I
rH
' §
* *
i S3

s5n
ill
HW
^•Or< S
*— g ^^
a o "o
M C W

§U O, ©
0 0 rH
X *H J** Ll O
SiS-Sc?
Is i
v^
mi •
X Q« fl»

S S £
S  "N, U
rH • * O
*4 X X W
££££
a~ o -3
S c 2
lsll
t
c
.H 3"i a?
• e to o
IIII
I ,
S 3s
32
IM O
U
-•3

BlSl
0 co «>co «>co «>co
*H tH tH TH
-



g g g g .

S S 3» S


O >i C

Li Li O
c P=
Ll O rH rH
CX O Ll rH
01 CQ (0 (0
rH r-7 *. ».
Ll rH 4J ' 4->
(0 flj C C
W lu S 0)
J-> -U flj fO
n c g 0)
S E -IJ 4-> Id
ej « oJ JJ tu
SO W W I
Lt <3 U <0 Z
4J 4J t) 0) U O
>* -a >i ts z
K T3 13 (0 « (0 "»K
CC C C 0 U 0 Q
U KJ JJ (t) LiQ.M^O
D3 Xlg) XI- X1W XJ1) O
U >i >i tu
ZrHAIrH i-tSH« 1
Bi-f 14 -iH -iHO -H S-4 Z
00,0 oo oao
>« CO W CQ COCQ CQ W Z







s s s s


CO CQ CQ CO
=z z z z
'1 § i z
CQ CO CQ CO
z z z z


CQ CO CQ CO
Z Z Z Z


CC CO CQ CC CQ CQ
S Z Z E- Z Z
CO CO
CC K
tu CO CQ bu CQ CO
Z Z Z Z
3* CuSOIwSO 3* feiSO CwSO
O O
s <« <«"
(U  04 -a-  CM -V <£>
MCSltH COCMrH COCMTH'olCsltH




g g g g.

1: ^ |c §


Ll Ll
Q) ' fl)
(0 (0
Ll M
O, i-l G. M
(0 Q) « W 0)
Tl S" S T1 n?
C U W C 'U
« - Q, CQ ffl a
CQ tQ CC TO (0
>J C O WC >O
Cu ffl CQ CC  i-l
CQ C 0 Iw C 0
*^. Q) Q ~ O Q
CO 5 - Q 5 «.
W OS -U O (3 4->
cc ai oi Q i> w
gj-i m S s-i 
-------
0

H














































P-
O
m
a!
•H
-H ffl
4J W
1°.
O
•H
•§.
ro.
i-l
O 05
o o
5 .
w >
1 4J 4J
K SS
•|« '
2 52
M 1-1
— TJ < S
~S^:£I
Q> O 0) *
w c w
Q w|
X rH £ S "O
a C 4J 0 >i
S 3 o \ o
to OJ JH
Q.4J 3
rH • • 0)
•H SC X W
O  "3"
till-
-P - u
/S ti) 5
2 rH 0
§
1
c
rH Q) 0)
Q.JH JJ W
5*" C*S
i-l
- OJ W 0>
C -P w X
aaag-
t
S, 3 S
id 'c
a°-
*J3 (lj
•rH
O rH 1-1
rH CO
SITE- Application Type, Applicat
Timing, Application Equipment
Surface Type (Antimicrobial o:
cy Influencing Factor (Antimi




















































2
'USES ELIGIBLE. FOR REREGISTRATIO]
NON-FOOD/NOM-FEED (con't)




























jj
|

: FORESTRY
a
1
3 .
w















4J

§
— '
COTTONWDOD (FOREST/SHELTERBELT)



(D
o



' /







£


g

g
. g




CO
2 ;


CO
2
g
»XU
'
jo ja x>
(H .-4 rH
VT> V£> CM










• =

g





Broadcast, Dormant, Sprayer



10
o











g


g

g
g




g


g
g
t" S 9

2S> X)
rH t-H
U> U> CM










"K

g





Broadcast, Postplant, Sprayer



-  10 CM










g '•

g





Broadcast, Preplant, Sprayer



-*0

'333
VD W CM










"

g
3 '
L4

2
w
Directed spray, Delayed dormant,










-



















: FORESTRY
a
-J
O
u
0)
g



















POPLAR (FOREST/SHELTERBELT)
8 8 8
EV . tT cT
g g g
u> u? ID"
3 . S 5











cc a: ' B:
0 - 0 ,0


N CM CM
T-t rH - rH

CO CO CO
= 2 2 2
SCO CQ
2 2




CO CO CO
S 2 -2
4

W CO CO
22 2
CO CO • CO
fciSo CuSo fciSO

g << 0 < < O < <
xi & JQ ja ^.Qja
•H rH rH rH . rH rH
^O CM  CM
t-H T-H . t-l rH tH rH









S g g

% & a
S S 3
u

2 . in
Q. U
W o.
Broadcast, Dormant, Boom sprayer
Soil treatment, Postplant, Boom
Soil treatment, Preplant, Boom s
















- B


. g

g
CO
' Z




g


FORESTRY
NS NS
'1 "
O

CM -
CO (


-.






g

6
S


E
re
SYCAMORE (FOREST)
Band treatment. Dormant, Band sp

-------
  o

  3

  S ,

 ,-fi-J
S3
 .t-S
 c o >•
 m
 '&*}
HS?9
I   ,
•S ''••S S
&-3-8S
<< b* u
  W O 14
§43-?
>tH *H O -H
t-4 
-------
M
D
J

























































r-
o

m
rH
1

1


cn en
•X.'x,
CO CJ
0 0
ss
,0 O
a> 0
jJ JJ •
ss
G 4J
X. 0
P&
Lt 05
O
d) ce
CC Cu,.





































g
2
§
<:
X
S
Z •
1 u
0J
s .
















3
O
(0
1

1-1
CM
v-i
0
rH
Rj
o
•d
ase 0039 [TerbacilJ Chen
0
••H
' 3
CT
Ed
•1
"g.
. S
~0)


^*
c
0
•H
4J
RJ
O
ft
&


: - a -
i-t



aj
s
'§•
S


0)
s

'o '

., nj
a

fl)
•H P
W W
Is
"w
*• CJ
S3
S|
Si
£ 1
f -H
G C
5S

o >,
O JJ
by -H
1 JJ
C C
O ,
C) <
<1) -V.
Cu JJ
T3 C
O D
£ 0)
4J
^5
C CC
O"
/ . -H C
P 0
nJ -H
LI jJ
P a
to o
0.2
o) a
i1*
£g

, O «iH
»W X
Ig
rH JJ
(D (0
GrH
(H 3
EGEND' - .
Sort: Uses Eligible or
Description, Form
•-^ U
C J2
O Q> JJ

(0 , n S
•H IW
1 rH • flj
a ' o>
a jj -a
<0 , (0 Ct)
' ' 10 JJ
•H tO
** . £ -H
= JJ tJi
£*< ^-i £
O
«H W
*N. W JJ

• W T? O
*H "O G
CO) -fl) rH
O W O rH
W nj
M 0) JJ
>t g Lt G JJ
»-H -Ha 0> RJ
G nj X S J2
O rH 0) 3 P
O CJ
1 w o a)
tO -H S DJ C
•3 .3 S3 g|
fi& g§
« a) o a-

^ — i S3
CO nj s JJ
0 CJ Tf To *
0) .. . J= JJ
S . £ P (1) Lt ' JJ Ll
tJ •£ rrf & ff *a a
w to d) £ >i GO)
>i >i D S ' (0 Ll
CO CO X Ll - —
SU O to '
•O-H
* • <1) ni <-;
JJ JJ . JJ tt) cj j-
••H '*H >H JJ >i tt) C
w to to co o a-H
rH i-H rH 0) O tO 0

G C C (0 O Ll 3
^H -H ^H 01 O rH
to to wo o • • — * o
Q rH WO>C
08 * ^iS >-H
O • o' O 1 -H -O JJ <0
4JJJ pg « — OJJ
O. ' O O (0 C 0)
•iH «iH -HE Ll O Ll '
StO (8 JJ > JJ 2 (0
O O (0 O (0 .C
•J -H rHwlifl) ^ (0>,
a a a c > O>*H O tt) 3 -Q JJ
c c CrHtajj to -o a
"rf Tf -H Q. « 2 OTOffJ
tO CO W a *O. JJ L( -H O
t, « ,t!m3 ^WrH^S
X S LiOWa «HrH«HLtJ2
IM in IHLILita >I> JJ
H) Q) © ^ X 0 CDt S ^ a: tj 2 -o
•• •• — •• .. .. .. ..
to tq
to to
(D (U -
rH i-H (U
C -h C JJ
33 tO CO
W - . CC W
Z rH I-H 0) Q) — .
0 < < W . 'rH < «
£~ " Q rt 3^ S,
g^f £$ -s -MSl .5
BS-SS^I® s-g-BS
g . S . S22. MS£5^
CQrHj3rHj3 *a CO.CIU Ll
,o
_aoaoo) oocwa '
«< < EHstt Q MJJO?
,W T3 -O TJ C K
Q • V - 0) rH ' • •OJ-itl

•P Q) ifl
•H (0
'•Ha"
O »
«'S
o «.
to -H
•P C 14
-H d> JJ
to a w
.fi W '
-H •.
JJ CJ
-H *.-H
(0 Ll JJ •
,Q< 0) 0]
c

nj .p .S*
.Q G (3
O JJ
•• CJ CO
2 . .
•H Li (U
3 M -H
1* I *
S *• JJ •
• rH IH 8
rH O .G
O' O W
«w w'jJ*
0 -0* 3
C fH J2
O Li
JJ CJ
j2 U Q)
JJ « W
* tT
LI a) CD
O rH W
*. 3
CD O g

o a .H
Ifo
rH (0 CJ
O Q)
O -H
JJ * a
UC : Unconverted due
briquets, bursts
parts, pellets,






































































APPLICATION RATE






























•




































•a
0)
JJ 0)
Calcula
i be mad

>i CM
iH
LI S
O
JJ •*
J2 0>
D* O
•H C
S -S
to
£ -S
Q> O
•H
CP •*
to x"
•H X
t
S m
U : Unknown whether ]
cwt : Hundred Weight
nnE-xx : nn times (10 powi


































,



































USE LIMITATIONS CpDES"'
C14 : Grown for seed only.


CO
H
J































































p-
O
tft
•H

port Run Date: 09/08/97 -
D Report Date: 07/02/96
0) t£
a: o,




































2

K



8
•z.
u
Cu.
a


















rH
•H
O
(0
XI
LI
£
r-{,
0
5-
i-l
0

S
1
•H
-H
O
I
at
n
o
o
0)
(0
(0
O













ii
LI


LI
0)
1
f
J3
&
,. • ^
G
(d
2
i 0
— C JJ
• (0
> O» JJ
U 3 O
*— O (P
1 JJ *CJ
1 rH rH
to a °*
O O
c .c
BB
ts> s
•^ .<
O o



-------
     10
  !3 §
&&& |3
ffi C\ tO rH 2:

8S3SS.
               til.
              > D W .C
        §
•H O
 C U

 2 e


its,
i* C W i
                                                                                  oo
                                                                                  o

-------
              .                 GUIDE TO APPENDIX B
 Appendix B contains listings of data requirements which support the reregistration for active
 ingredients within the case TERBAGIL covered by this Reregistration  Eligibility Decision
 Document. It contains generic  data requirements that apply  to TERBACIL hi all products,
 including data requirements for which a "typical formulation" is the test substance.

       The data table is organized in the following format:

       1. Data Requirement (Column 1).  The data requirements are listed in the order in which
 they appear in 40 GFR Part 158.  the reference numbers accompanying each test refer to the test
 protocols set hi 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.
                                        109

-------
110

-------
                        APPENDIX B
    Data Supporting Guideline Requirements for the Registration of
                              TERBACIL
REQUIREMENT
USE PATTERN
                        CITATION(S)
PRODUCT CHEMISTRY
61-2A
61-2B
62-1
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-11
63-12
63-13
63-17
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Octanol/Water Partition
PH
Stability
Storage stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42199001, 00012366, 00142302
42199001, 00012366
00012364, 00067336, 00142302
00011958
00011958
00011958
00011958
42335302, 00011958
00011958
42335303,00011958
00125692
42335302
42335301
42335301
ECOLOGICAL EFFECTS
71-1A     Acute Avian Oral -            ALL
          Quail/Duck
71-2A     Avian Dietary - Quail          ALL
72-1A     Fish Toxicity Bluegill           ALL
72-1C     Fish Toxicity Rainbow Trout     ALL
72^2A     Invertebrate Toxicity           ALL
72-3A     Estuarine/Marine Toxicity -       AB
          Fish
           00157177

           00012346, 00012347, 241146
           00390019, 00025224
           00390017, 00025223, 44150201
           00390018, 249455,125705
           41896101, 41896100
                                 111

-------
     Data Supporting Guideline Requirements for the Reregistration of
                                TERBACIL
 REQUIREMENT
USE PATTERN
              CITATION(S)
 72-3B      Estuarine/Marine Toxicity -
           Mollusk
 72-3C      Estuarine/Marine Toxicity -
           Shrimp
 123-1A     Seed Germination/Seedling
           Emergence
 123-1B     Vegetative Vigor
 123-2      Aquatic Plant Growth

 141-1      Honey Bee Acute Contact
 TOXICOLOGY
 81-1       Acute Oral Toxicity - Rat
 81-2       Acute Dermal Toxicity -
           Rabbit/Rat
 81-3       Acute Inhalation Toxicity -
           Rat
 81-4       Primary Eye Irritation -
           Rabbit
 81-6       Dermal Sensitization -
           Guinea Pig
 82-1A      90-Day Feeding - Rodent
 82-1B      90-Day Feeding - Non-rodent
 82-2       21-Day Dermal - Rabbit/Rat
 83-1A      Chronic Feeding Toxicity -
           Rodent
83-1B      Chronic Feeding Toxicity -
             Non-Rodent
83-2A      Oncogenicity - Rat
    AB     00012332,00012333
    AB
00012332
   ALL     43895801,42336701
   ALL     43895801,42336701
   ALL     43929802, 43909802, 42306101,
            43929801
    AB     00018842
   ALL     00150946,114693, 24955
   ALL     00130945,114693, 24955

   ALL     00125700

   ALL     00157179

   ALL     00157180

   ALL     00068035,00039009
   ALL     00060851
   ALL     00125785,00148006
    AB      42987601

    AB      00060851

    AB      42987601
                                    112

-------
     Data Supporting Guideline Requirements for the Registration of
                                TERBACIL
 REQUIREMENT
USE PATTERN
                          CITATIONS
83-2B      Oncogenicity - Mouse
83-3A      Developmental Toxicity - Rat
83-3B      Developmental Toxicity -
           Rabbit
83-4       2-Generation Reproduction -
           Rat
84-2A      Gene Mutation (Ames Test)
84-2B      Structural Chromosomal
           Aberration
84-4       Other GenotoxicEffects
85-1       General Metabolism
ENVIRONMENTAL FATE
161-1      Hydrolysis
161-2      Photodegradation - Water
161-3      Photodegradation - Soil
162-1      Aerobic Soil Metabolism

162-2      Anaerobic Soil Metabolism

163-1      Leaching/Adsorption/Desorpt
           ion
164-1      Terrestrial Field Dissipation
165-2      Field Rotational Crop
165-4      Bioaccumulation in Fish
    AB     42031601,00126770
   ALL     00050467,00039001
   ALL     00150945

   ALL     00060852

   ALL     00155103,00150943
   ALL     00157181,00150944

   ALL     00150939,00155103
    AB     40104702

   ALL     0001946,41136301
   ALL     00011946
   ALL     001600235
   ALL     05024336, 05013204, 05016176,
            42369901
   ALL     42370001,05024336,05013204,
            05016176
   ALL     05013202,42335401,00155104,
            05014424, 05008371, 05014175
   ALL     43585500, 05017062, 05014421
   AB      42369901
   ALL     00011947
                                   113

-------
    Data Supporting Guideline Requirements for the Reregistration of
                                TERBACIL
REQUIREMENT
USE PATTERN
              CITATION(S)
RESIDUE CHEMISTRY
171-4A     Nature of Residue - Plants
171-4B     Nature of Residue - Livestock

171-4C     Residue Analytical Method -
           Plants
171-4E     Storage Stability
           Nongrass Animal Feeds
           -Alfalfa forage & hay

           Pome Fruits Group
           -Apples
   ALL     44080101, 43909801, 00011965,
            00012014, 05002415, 05013194,
            05013216, 05013598
   ALL     42809401, 42717101, 00011950,
            00011957
   ALL     42740301, 42740302, 42740303,
            42740304,42465202
   ALL     00011952,00150369,42885201
    AB     00011959, 00130415, 00144089,
            00149202, 42335601
    AB     44048901, 00070784, 00012015,
            00012402, 00149184, 00157178
           Miscillaneous Commodities
           -Asparagus
           -Mint hay/Peppermint
           -Surgarcane

           Berries Group
           -Blueberries
           -Caneberries
           -Strawberries
    AB     00028524,42465201
    AB     00012067, 00012103, 42335501
    AB     00012179, 00012180, 00157178,
            44048903

    AB     00012039, 05013352, 44177101
    AB     05015405, 00390015, 44177102
    AB     00012097
          . Stone Fruits
           -Peaches
    AB
00012402, 00128574, 00149184
                                   114

-------
    Data Supporting Guideline Requirements for the Registration of
                              TERBACIL
REQUIREMENT
USE PATTERN
                         CITATIONS
          Grass Grown Soley for Seed
          -Grass Forage/Fodder/Hay
    AB
42692501
171-4L     Processed Food
          -Apples
          -Mint
          -Sugarcane
    AB     00012067,44048902
    AB     00012067, 00012103, 42345201
    AB     00012179, 00012180, 44048904
                                 115

-------
116

-------
                        GUIDE TO APPENDIX C

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

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

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

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

a     Author.  Whenever the author could confidently be identified, the Agency has
      chosen to show a personal author.  When no individual was identified, the
      Agency has shown an identifiable laboratory or testing facility as the author.
      When np 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 hi the document.  When the date appears
                                  117

-------
as (19??), the Agency was unable to determine or estimate the date of the document.

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

Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (hi 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 hi 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.
                            118

-------
                                BIBLIOGRAPHY
 MRID
                    CITATION
00003401


00011946
00011947
00011950
00011965
00012015
00012039
00012067
00012097
 Gessert, R.  (EPA Memorandum to R., Taylor) re: upgrading of data from 3-
 generation rat reproductive study. January 20, 1983.

 Rhodes, R.C. (1975) Biodegradation Studies with 2-14C-Terbacil in Water and
 Soil.  (Unpublished study received Nov 25, 1975 under 4F1428; prepared in
 cooperation with Univ. of Delaware, College of Agricultural Sciences,
 submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del •
 CDL:094842-A)

 Rhodes, R.C. (1969?) Four Week Residue Studies with 2-14C-Terbacil and
 Bluegill Sunfish. (Unpublished study received Nov 25, 1975 under 4F1428;
 prepared in cooperation with Cannon Laboratories, Inc., submitted by E.I. du '
 Pont de Nemours &  Co., Inc., Wilmington, Del,; CDL:094842-B)

 Han, J.C. (1973?) 2-14C-Terbacil Goat Metabolism Study.  (Unpublished study
 received Oct 1,  1974 under 4F1428, submitted by E. I. du Pont de Nemours &
 Co., Inc., Wilmington, Del.; CDL:093805-B)
                                                              \

 Rhodes, R.C. (1964?) Studies with 14C-Labeled Terbacil in Alfalfa.
 (Unpublished study received Aug 30, 1973 under 4F1428; submitted by E.I. du
 Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:093806-J)

 E.I. du Pont de  Nemours and Company (1966) Results of Tests on the Amount
 of Residue in Crops Grown on Treated Soil.  (Unpublished study received Dec
 13, 1966 under 6F0510; CDL:090603-N)

 IR-4 Project at Rutgers, the State University (1973) Results of Tests on the
 Amount of Residue Remaining on Treated Blueberries: (Terbacil).
 (Unpublished study received Dec 19, 1975 under 6E1719; prepared in
 cooperation with DuPont Co.; CDL:095364-A)

E.I. du Pont de Nemours & Company (1975) Results of Tests on the Amount of
Residue Remaining on Treated Crops: [Terbacil].  (Unpublished study received
Dec 3, 1975 under 6F1713; CDL:095184-C)

IR-4 Project at Rutgers, the State University (1972) Analytical Residues:
 (Terbacil). (Unpublished study received Mar 14, 1977 under 7E1936-
CDL:097354-A)
                                       119

-------
                                BIBLIOGRAPHY
MRID
CITATION
 00012103    E.I. du Pont de Nemours and Company (1966) Results of Tests on the Amount
             of Residue in Crops Grown on Treated Soil: [Terbacil].  (Unpublished study
             received Nov 16, 1966 under 7F0549; CDL:092838-B)

 00012179    E.I. du Pont de Nemours and Company (1966) Sinbar Weed Killer Residue
             Data—Sugar Cane: Supplemental Information.  (Unpublished study received
             Apr 13, 1966 under unknown admin, no.; CDL:124198-A)

 00012180    E.I. du Pont de Nemours and Company (1966) Sinbar Weed Killer (3-
             —Aiterfyt—Butyl-5-cMoro-6-methyluracil) Residue Data—Sugar Cane.
             (Unpublished study received Feb 9, 1966 under unknown admin, no.;
             CDL:124200-A)

 00012332    Bentley, R.E. (1973) Bioassay Report Submitted to E.I. du Pont de Nemours &
             Co.: Sinbar Terbacil Weed Killer, 80%  Wettable Powder: Acute Toxicity of
             H-8309 to Grass Shrimp 0* ~ Palaemonetes vul ~ jt-ji ~ garisju. ~ ) and Fiddler
             Crab Oi~Uca pugilator/i-). (Unpublished study received Apr 11, 1974 under
             352-17; prepared by Bionomics, Inc., submitted by E.I. du Pont de Nemours &
             Co., Wilmington, Del.; CDL: 129203-B)

 00012333    Bentley, R.E. (1973) Bioassay Report Submitted to E.I. du Pont de Nemours &
             Company, Newark, Delaware: Sinbar Terbacil Weed Killer, 80% Wettable
             Powder: Acute Toxicity of H-8309 to Atlantic Oyster 0*~Crassostrea
             virginica/i~).  (Unpublished study received Apr 11, 1974 under 352-317;
             prepared by Bionomics, Inc., submitted by E.I. du Pont de Nemours & Co.,
             Wilmington, Del.; CDL:129203-C)

00012346    Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1966) Acute Toxicity in Wildfowl
             (Pheasant Chick). (Unpublished study received on Jan 11,  1978 under 352-317;
             prepared by International Research and Development Corp., submitted by E.I.
             du Pont de Nemours & Co.,  Wilmington, Del.; CDL:096709-B)

00012347  . Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1966) Acute Toxicity in Wildfowl
             (Pekin Duckling). (Unpublished study received on Jan 11,  1978 under
             352-317; prepared by International Research and Development Corp.,
             submitted by E.I. du Pont de Nemours & Co., Wilmington, Del.;
             CDL:096709-C)
                                       120

-------
                               BIBLIOGRAPHY
 MRID
                   CITATION
 00012364
 00012366
00012402
00013286
00012424
00013287
00013288
 E.I. du Pont de Nemours and Company (19??) Composition of Technical
 Terbacil: Active Ingredient in Sinbar Weed Killer.  (Unpublished study
 received Nov 7, 1978 under 352-317; CDL:235690-A)

 E.I. duPont de Nemours and Company (19??)  Purity of Starting and
 Intermediate Materials Used in the Terbacil Manufacturing Process.
 (Unpublished study received Nov 7, 1978 under 352-317; CDL: 235690-C)

 E.I. du Pont de Nemours & Company (1973) Daja Supporting the Use of
 Zobar*Weed Killer in Established Apples and Peaches. Summary of studies
 026721-B through 026721-Y. (Unpublished study received Oct 17, 1973 under
 352-374; CDL:026721-A)

 Yamane, G.M. (1968) Crop Tolerance for Hyvar X, DuPont 732, and DuPont
 767 Experimental Herbicides. (Unpublished study received Mar 24, 1970
 under 352-287; prepared by Pineapple Research Institute, submitted by E.I. du
 Pont de Nemours & Co.,  Wilmington, Del.; CDL:00 E.I. du Pont de Nemours
 & Co., Wilmington, Del.; CDL:026721-X)

 Ratto, D.B. (1972) To Test Zobar I & Zobar 21 for Weed Control in Apples.
 (Unpublished study received Oct 17, 1973 under 352-374; submitted by E.I. du
 Pont de Nemours & Co.,  Wilmington, Del.; CDL:026721-Y)

 Yamane, G.M. (1968) Crop Tolerance for Hyvar X, DuPont 732, and DuPont
 767 Experimental Herbicides. (Unpublished study including incomplete letter
 dated Jan 4, 1967 from G.M. Yamane to Wayne D. Grogg and letter dated Jul
 29, 1968 from M.F. O'Brien to Don L. Bufgoyne, received Mar 24, 1970
 under 352-287; prepared by Pineapple Research Institute in cooperation with
 Dole Co. and Hawaiian Fruitpackers, submitted by E.I. du Pont de Nemours &
 Co., Wilmington, Del.; CDL:002922-I)

 Yamane, G.M. (1968) Soil Persistency of Hyvar X. Rev.  (Unpublished study
including letter dated May 3,  1968 from D.L, Burgoyne to H.L. Pease,
received Mar 24, 1970 under 352-287; prepared by Pineapple Research
Institute, submitted by E.I. du Pont de Nemours & Co., Wilmington Del •
CDL:002922-K)                           .                  '    "
                                      121

-------
                                BIBLIOGRAPHY
 MRID
CITATION
 00017711    Liu, L.C.; Cibes-Viade, H.R.; Gonzalez-Ibanez, J. (19??) Persistence of
             several herbicides in a soil cropped to sugarcane. Journal of Agriculture of
             University of Puerto Rico ? (? ):147-152.  (Also-In-unpublished submission
             received Aug 20, 1976 under 39445-1; submitted by American Carbonyl, Inc.,
             Tenafly, N.J.; CDL:228229-Y)

 00025223    McCann, J.A.; Pitcher, F. (1972) [Sinbar Terbicil Weed Killer: Toxicity to
             Rainbow Trout]: Test No. 520.  (U.S. Environmental Protection Agency,
             Pesticides Regulation Div., Agricultural Research Center, Animal Biology
             Laboratory, unpublished report.)

 00025224    McCann, J.A.; Pitcher, F. (1972) [Sinbar Terbacil Weed Killer: Toxicity to
             Bluegill Fish]: Test No. 515.  (U.S Environmental Protection Agency,
             Pesticides Regulation Div., Agricultural Research Center, Animal Biology
             Laboratory, unpublished report.)

 00028135    Isom, W.H.; Ford, H.P.; Lavalleye, M.P.; et al. (1969) Persistance [sic] of
             Herbicides hi Irrigated soils.  (Unpublished study received Aug 20, 1976 under
             39445-1; prepared by Sandoz-Wander, Inc., submitted by American Carbonyl,
             Inc., Tenafly, N.J.; CDL:228229-X)

00028524    Interregional Research Project Number 4 (1976) (Terbacil Residue Data
             Summary: Asparagus). (Unpublished study received Jun  11, 1980 under
             OE2371; CDL:099449-A)

00039001    Haskell Laboratories, Rat Oral Teratology with Terbacil, received February
             20, 1980, submitted by E.I. du Pont de Nemours & Company, Inc.,
             Wilmington, Del.

00039009    Haskell Laboratoris, Rat 90-day feeding study hi Rats, received June 28, 1965,
             submitted by E.I. du Pont de Nemours 7 Company, Inc.,  Wilmhigton, Del.

00060851    Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1967) Two-Year Feeding Study in
             the Dog: IRDC No. 125-011.  (Unpublished study received Apr 4, 1967 under
             6F0510; prepared by International Research and Development Corp., submitted
             by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.; CDL:090602-A;
             090600)
                                        122

-------
                                BIBLIOGRAPHY
 MRID
                    CITATION
 00060852
 00067336
00068035
00070784
00114693


 00125700
00125705
00125785
 Wazeter, F.X.; Buller, R.H.; Geil, R.G. (1967) Three-Generation
 Reproduction Study in. the Rat: IRDC No. 125-012. (Unpublished study
 received Apr 4, 1967 under 6F0510; prepared by International Research and
 Development Corp., submitted by E.I. du Pont de Nemours & Co., Inc;,
 Wilmington, Del.;  CDL:090602-B; 090600)

 Karrh, B.W. (1976) Letter sent to John E. Moss dated Oct 4, 1976 [Results of
 analyses of du Pont pesticides for dimethylnittosamines (DMN)].  (Unpublished
 study received.Dec 8, 1976 under 352-378; submitted by E.I. du Pont de
 Nemours & Co., Wilmington, Del.; CDL:230783-A)

 Wazeter, F.X.;  Buller, R.H.; Geil, R.G. (1964) Ninety-day Feeding Study in
 the Rat: IRDC No.  125-004. (Unpublished study received May 20,  1981 under
 352-317; prepared by International Research and Development Corp.,
 submitted by E.I. du Pont de Nemours & Co., Wilmington Del •
 CDL:245112-D)

 Stauffer Chemical Company (1980) DevrinolA(R)=4-F Selective Herbicide:
 Summary of Crop Residue Data on Apples, Peaches, and Cit rus.
 (Compilation; unpublished study received Dec 11, 1980 under 476-2199-
 CDL:243860-A)

 Haskell Laboratories, 14-day Rat Feeding Study, received June 25, 1965,
 submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, Del.

 Burgess, B.; Ferenz, R.; Koechert, M. (1982) Inhalation Median Lethal
 Concentration (LC50): [IND-732-38]: Haskell Laboratory Report No. 351-82.
 (Unpublished study  received Qct 9, 1982 under 352-317; submitted by E.I. du
 Pont de Nemours & Co.,  Inc., Wilmington, DE; CDL:249455-J)

 Phillips, F.; Hall, C. (1981) 48-hour LC50 to Daphnia magna: [Terbacil]:
 Haskell Laboratory  Report No. 392-81.  (Unpublished study received Oct 9,
 1982 under 352-317; submitted by E.I. du Pont de Nemours & Co   Inc
 Wilmington, DE; CDL:249455-O)                                      ,

 Hood, D. (1966) 15-exposure Skin Absorption Studies with 3-tert-Butyl-5-
chloro-6-methyluracil: Report No. 33-66. (Unpublished study received Feb 15,
 1983 under 352-317; submitted by E.I. du Pont de Nemours & Co.,  Inc.
Wilmington, DE; CDL:249517-A)          "     ,
                                       123

-------
                                BIBLIOGRAPHY
MRID
CITATION
00126770    Goldenthal, E.; Roman, S.; Richter, W. (1981) 2-year Feeding Study in Mice:
             [Terbacil]: 125-027. (Unpublished study received Apr 5, 1983 under 352-247;
             prepared by International Research and Development Corp., submitted by E.I.
             du Pont de Nemours & Co., Inc., Wilmington, DE; CDL:249907-A; 249908;
             249906)                        '

00130415    E.I. du Pont de Nemours & Co., Inc. (1983) Residue Data: (Terbacil and
             Others on Alfelfa).  (Compilation; unpublished study received 1983 under
             352-317; CDL:251051-B)

00130945    Hood, D. (1965) Acute Skin Absorption Toxicity: [3-tert-Butyl-5-chloro-
             6-methyluracil: Rabbits]: Haskell Laboratory Report No. 76-65.  (Unpublished
             study received May 1, 1981 under unknown admin,  no.; submitted by E.I. du
             Pont de Nemours & Co., Inc., Wilmington, DE; CDL:251081-C)

00138467    E.I. du Pont de Nemours & Co., Inc. (1979) 96-Hour LC50 to Bluegill
             Sunfish: OUracil:  Haskell Laboratory Report No. 701-78. (Unpublished study
             received Oct 16, 1979 under 352-317; CDL:  241146-A)

00142302    E. I. du Pont de Nemours and Co., Inc. (1984) "Product Chemistry to Support
             Terbacil Reregistration". Unpublished study.  27 p.

00144089    E.I. du Pont de Nemours and Co., Inc.  (1984) Residue Data to Support
             Terbacil and Its Metabolities on Alfalfa at the Increased Maximum Rate of 2
             Lb/a/Yr by Split Application int he Northeast U.S. Unpublished compilation.
             lip.

00149202    E.I. du Pont de Nemours Co., Inc. (1982) Du Pont Sinbar Weed Killer Aerial
             Application-Alfalfa: Residue Data.  Unpublished study.  8 p.

00150945    Solomon, H. (1984) Embryo-Fetal Toxicity and Teratogenicity Study of
             Terbacil by Gavage in the Rabbit: Medical Research Project No.  4512-001:
             Haskell Report No. 528-83. Unpublished study pre pared by E.I. du Pont de
             Nempurs & Co., Inc., Haskell Laboratory for Toxicology and Industrial
             Medicine. 73 p.

00150946    Cortina, T. (1984) Acute Oral Toxicity  Study hi Rats: H #14,673: Final
             Report: Project No.: 201-713.  Unpublished study prepared by Hazleton
             Laboratories America, Inc. 21 p.

                                       124

-------
                                 BIBLIOGRAPHY
 MRID
                    CITATION
 00155103
 00155104



 00157,177



 00157179



 00157180



 00157181



 00160235



 0249455


00260460


05002415
 McCooey, K. (1984) Unscheduled DNA Synthesis/Rat Hepatocytes k vitro:
 Haskell Laboratory Report No. ,379-84: MR No. 4581-143. Unpublished study
 prepared by E.I. du Pont de Nemours & Co., Inc.; Haskell Laboratory for
 Toxicology and Industrial Medicine, lip.                         ,

 Priester, f. (1985) Batch Equilibrium (Adsorption/Desorption) and Soil
 Thin-layer Chromatography Studies with p2-Carbon-14o Terbacil.
 Unpublished study prepared by E.I. du Pont de Nemours & Co., Inc.  45 p.

 Beavers, J. (1986) H #14,673: An Acute Oral Toxicity Study with the
 Bobwhite: Final Report: Project No. 112-168. Unpublished study prepared by
 Wildlife International Ltd. 17 p.

 Gargus, J. (1985) Primary Eye Irritation Study in Rabbits:  Haskell No. 14,673:
 Final Report: Project No. 201-867.  Unpublished study prepared by Hazletpn
 Laboratories America, Inc.  20 p.

 Henry, J. (1986) Skin Sensitization Test of Terbacil (IND-732-53) in Guinea
 Pigs for EPA Pesticide Registration:  FRevisedo: Rept. No. 600-85: MR No.
 4581-277.  Unpublished study prepared by Dupont Haskell Laboratory. 9 p.

 Cortina, T. (1984) In vivo Bone Marrow Chromosome Study in Rats: H#
 14,673: Final Report: Project No. 201-695.  Unpublished study prepared by
 Hazleton Laboratories America, Inc.  6 p.

 Barefoot, A. (1986) Photolysis, of Terbacil on Soil: Document No.
 AMR-521-86. Unpublished study prepared by E. I. du Pont de Nemours and
 Co., Inc. 63 p.

 Haskell Laboratories, 3-week Rabbit Dermal Toxicity Study, received June 28
 1965, submitted by E.I. du Pont de Nemours & Co.,,Inc.

Haskell Laboratories, CHO (HGPRT) Gene Mutation Assay with Terbacil,
 received March 1, 1984, submitted by E.I. du Pont de Nemours & Co., Inc.

Gardiner, J.A.; Rhodes, R.C.; Adams, J.B., Jr.; Soboczenski, E.J. (1969)
Synthesis and studies with 2-C14-4abeled bromacil and terbacil. Journal of
Agricultural and Food Chemistry 17(5):980-986.
                                        125

-------
                                BIBLIOGRAPHY
MRED
CITATION
05008371     Rao, P.S.C.; Davidson, J.M. (1979) Adsorption and movement of selected
             pesticides at high concentrations in soils. Water Research 13(4): 375-380.

05013194     Weierich, A.J.; Nelson, Z.A.; Appleby, A.P. (1977) Influence of fonofos on
             the distribution and metabolism of 14C-terbacil in peppermint.  Weed Science
             25(l):27-29.

05013201     Marsh, J.A.P.; Davies, H.A. (1978) The effect of herbicides on respiration and
             transformation of nitrogen in two soils: niJLenacil, terbacil, chlorthiamid and
             2,4,5-T. Weed Research 18(l):57-62.
05013202     Marriage, P.B.; Khan, S.U.; Saidak, W.J. (1977) Persistence and movement of
             terbacil in peach orchard soil after repeated annual applications.  Weed
             Research 17(3):219-225.             .

05013204     Wolf, B.C. (1974) Degradation of bromacil, terbacil, 2,4-D and atrazine in soil
             and pure culture and their effect on microbial activity. Dissertation Abstracts
             International B34(10):4783-4784.

05013212     Skroch,  W.A.; Sheets, T.J.; Smith, J.W. (1971) Herbicide effectiveness, soil
             residues, and phytotoxicity to peach trees.  Weed Science 19(3):257-260.

05013216     Rhodes, R.C. (1977) Metabolism of [2-14C]terbacil in alfalfa.  Journal of
             Agricultural and Food Chemistry 25(5):1066-1068.

05013351     Doughty, C.C. (1978) Terbacil phytotoxicity and quackgrass 0*~ Agropyron
             repens^i—) control in highbush blueberries (/*—Vaccinium corymbosumjB—).
             Weed Science 26(5):448-492.

05013352     Cessna,  A.J. (1977) Determination of terbacil in blueberries. Journal of
             Agricultural and Food Chemistry 25(2):432-433.

05013598     Jordan, L.S.; Zurqiyah, A.A.; Clerx, W.A.; Leasch, J.G. (1975) Metabolism '
             of terbacil in orange seedlings. Archives of Environmental Contamination and
             Toxicology 3(3):268-277.

05014175     Liu, L.C.; Cibes-Viade, H.; Koo, F.K.S. (1971) Adsorption of Atrazine and
             Terbacil by soils.  Journal of Agriculture of the University of Puerto Rico
             55(4):451-460.
                                         126

-------
 MRID
                    BIBLIOGRAPHY

                    CITATION
 05014421
 05014424"
 05015405
05017062
05019594
05020698
40104701
 40104702
 Mansell, R.S.; Calvert, D.V.; Stewart, E.H.; Wheeler, W.B.; Rogers, J.S.;
 Graetz, D.A.; Allen, L.H.; Overman, A.R.; Knipling, E.B. (1977) Fertilizer
 and Pesticide Movement from Citrus Groves in Florida Flatwood Soils.
 Athens, Ga.: U.S. EPA, Environmental Research Laboratory.
 (EPA-60072-77-177; available from:  NTIS, Springfield, VA; PB-272 889)

 Davidson, J.M.; Ou, L.T.; Rao, P.S.C. (1978) Adsorption, movement, and
 biological degradation of high concentrations of selected pesticides in soils.
 Pages 233-244, - In ~ Land Disposal of Hazardous Wastes.  Washington, D. C.:
 U.S. Environmental Protection Agency, Office of Research and Development
 (EPA-600/9-78-016)
                                                • v
 Holt, R.F.; Pease, H.L. (1977) Determination of terbacil and metabolite
 residues using microcoulometric gas chromatography. Journal of Agricultural
 and Food Chemistry 25(2): 373-377.

 Mansell, R.S.; Wheeler, W.B.; Calvert, DiV.; Stewart, E.H. (1979) Terbacil
 movement in drainage waters from a citrus grove in a Florida flatwodd soil.
 Pages 176-179, ~ In ~ Proceedings of the Soil and Crop Science Society of
 Florida; 1978. Vol. 37.  De Land, ,Fla.: Soil and Crop Science Society of
 Florida. (Florida Agricultural Experiment Stations journal series no. 1053)

 Isom, W.H.; Ford, H.P.;  Lavalleye, M.P.; Jordan, L.S. (1970) Persistance of
 herbicides in irrigated soils.  Pages 58-63, ~ In ~ Proceedings of the Annual
 California Weed Conference. Vol. 22. Sacramento, Calif.:  California Weed
 Conference.

 Benson, N.R. (1973) Efficacy, Leaching, and Persistence of Herbicides in
Apple Orchards. Pullman, Wash.:  Washington State University, College of
Agriculture Research Center.  (Washington State University, College of
Agriculture Research Center, bulletin no. 863)

Das, Y. (1987) Terbacil Anaerobic Soil Metabolism: Final Report: Project No.
85E602SM: Document No. AMR-651-87. Unpublished study prepared by
Biospherics Inc.  81 p.

Hawkins, D.; Mayo, B.; Biggs,  S.; etal. (1986) The Biokinetics and
Metabolism of  pCarbon 14o-Terbacil in Rats: HRC/DPT 143/861742:,
                                        127

-------
                                BIBLIOGRAPHY
MRID
CITATION
             Document No. AMR-758-87.  Unpublished study prepared by Huntingdon
             Research Centre Ltd.  118 p.

41136301     Acher, A.; Saltzman, S.; Brates, N.; et al (1981) Photosensitized
             decomposition of terbacil in aqueous solutions.  J. Agric. Food Chem.
             29:707-711.

41197801     Natella,  C.  (1980) Data Evaluation Record:  96-Hour LCSO to Rainbow Trout:
             Haskell Lab. Report No. 9-80: No. 058-783. Unpublished Review. 4 p.

41197802     Natella, C. (1981) Data Evaluation of US EPA Terrestrial and Aquatic
             Biology Unit Static Jar Test #2747:  Toxicity of Terbacil Technical to Daphnia
             magna.  Unpublished Review.  6 p.

41896101     Ward, T. (1990), Static Toxicity of Terbacil to Sheepshead Minnow,
             Cyprindon variegata.

42031601     Frame, S.;,Van Pelt, C. (1990) Oncogenicity Study with Terbacil in Mice
             Supplement Review: Lab Project Number: 415-81. Unpublished study
             prepared by E.I. du Pont de Nemours and Co.  64 p.

42199001     Keeler, D. (1992) Technical Terbicil: Description of Beginning Materials and
             Manufacturing Process: Discussion of Formation of Impurities.  Unpublished
             study prepared by E.I. du Pont de Nemours and Co.  19 p.

42306101     Hoberg,  J.; Bayne, M. (1990) Acute Toxicity of Terbacil to Selenastrum
             capricornutum Printz:  Lab Project Number: AMR-1860-90. Unpublished study
             prepared by Springborn Laboratories, Inc.  24 p.

42335301     Cadwgan, G.; Lee, P. (1992) Stability of Terbacil in the Presence of Metal and
             Metal Ions, in Sunlight and at Normal and Elevated Temperatures: Lab Project
             Number: AMR 2183-91.  Unpublished study prepared by E. I. du Pont de
             Nemours & Co. 22 p.

42335302     Cadwgan, G, (1992) Density and pH of Terbacil: Lab Project Number: AMR
             2182-91. Unpublished study prepared by E. I. du Pont de Nemours & Co. 12
             P-
                                        128

-------
                                BIBLIOGRAPHY
 MRID
                    CITATION
 42335303
 42335401
 42335501
42335601
42336701
42345201
42369901
42370001
42465201
 Barefoot, A. (1992) Vapor Pressure of Terbacil: Lab Project Number: AMR
 2404-92. Unpublished study prepared by E. I. du Pont de Nemours & Co. 12
 P-      •     •               •    '                  .

 Atkins, R:; Perdue, D.; Kesterson, A. (1992) Aged Soil Column Leaching of
 [carbon 14] Terbacil: Lab Project Number: AMR 2154-91: 1396: 597.
 Unpublished study prepared by PTRL East, Inc. 35 p.

 Lee, P. (1992) Magnitude of Terbacil Residues in Mint Hay after Sinbar
 Herbicide Application: Lab Project Number: AMR 1992-91:316W-1.
 Unpublished study prepared by E. I. du Pont de Nemours & Co., and
 PTRL-West.  56 p.

 Lee, P. (1992) Magnitude of Residues of Terbacil in Alfalfa Forage and Hay
 After Applications of Sinbar Herbicide: Lab Project Number: AMR 1991-91:
 3.15W-L Unpublished study prepared by E. I. du Pont de Nemours and Comp
 62 p.

 McKelvey, R.; Kuratle, H. (1992) Influence of Terbacil on Seed Germination,
 Seedling Emergence, and Vegetative Vigor of Several Terrestrial Plants: Lab
 Project Number: AMD 2073-91. Unpublished study prepared by E. I. du Pont
 de Nemours and Comp. 228 p.

 Lee, P. (1992) Magnitude of Residues of Terbacil in Spent Mint Hay and Mint
 Oil after Sinbar  Herbicide Application: Lab Project Number: AMR 1994-91.
 Unpublished study,prepared by E.I. duPont de Nemours and Co. and
 PTRL-West. 80 p.

 Atkins, R.; Perdue, D.; Kesterson, A. (1992) Aerobic Soil Metabolism of
 [carbon 14]-Terbacil: Lab Project Number: AMR 1689-90: 1403: 449.
 Unpublished study prepared by PTRL East Inc. 72 p.

 Atkins, R,; Perdue, D.; Kesterson, A. (1992) Anaerobic Soil Metabolism of
 [carbon 14] Terbacil: Lab Project Number: AMR1688-90: 1392: 450.
 Unpublished study prepared by PTRL East Inc. 75 p.

 Lee, P. (1992) Magnitude of Terbacil Residues in Asparagus after Sinbar
Herbicide Application: Lab Project Number: AMR 1993-91: 317W-1.
Unpublished study prepared by E.I.  du Pont de Nemours and Co.  61 p.
                                       129

-------
                                BIBLIOGRAPHY
MRID
CITATION
42465202    Kuo, A.; Nishioka, L.; Ruzo, L. (1992) Residue Method Validation for the
             Quantitation of Terbacil and its Metabolites in Mint, Apple, Sugarcane and
             Blueberries: Lab Project Number: AMR 1719-90: 234W-1: 234-W.
             Unpublished study prepared by Pharmacology and Toxicology Research
             Laboratory-West, Inc. 36 p.

42692501    Lee, P. (1993) Magnitude of Residues of Terbacil in Forage, Hay, Seed, Seed
             Screening, and Straw Following Applications of Sinbar Herbicide to Grass Seed
             Crops: Lab Project Number: AMR 2138-92: 350W-1.  Unpublished study
             prepared by E.I. du Pont de Nemours and Co. and PTRL-West. 187 p.

42717101    Krautter, G. (1993) The Metabolism of (carbon 14)Terbacil in the Lactating
             Goat: Lab Project Number: AMR-1979-91: 1335: 539. Unpublished study
             prepared by PTRL East, Inc. 106 p.

42740301    Fomenko, J. (1991) Testing of DPX-D732 through FDA Multi-Residue
             Protocols A through E: Terbacil: Lab Project Number: AMR-1836-90:
             DP004-01. Unpublished study prepared by Spectralytix, Inc.  64 p.

42740302    Fomenko, J. (1991) Testing of IN-G2449 through FDA Multi-Residue
             Protocols A through E: Terbacil: Lab Project Number: AMR-1837-90:.
             DP004-02. Unpublished study prepared by Spectralytix, Inc.  64 p.

42740303    Fomenko, J. (1991) Testing of IN-W2207 through FDA Multi-Residue
             Protocols A through E: Terbacil: Lab Project Number: AMR-1838-90:
             DP004-03. Unpublished study prepared by Spectralytix, Inc.  64 p.

42740304    Fomenko, J. (1991) Testing of IN-T2170 through FDA Multi-Residue
             Protocols A through E: Terbacil: Lab Project Number: AMR-1839-90:
             DP004-04. Unpublished study prepared by Spectralytix, Inc.  64 p.

42809401    Krautter, G. (1993) The Metabolism of (carbon 14) Terbacil in Laying Hens
             Following Oral Administration for 5 Consecutive Days: Lab Project Number:
             AMR 2330-92: 1486: 665.  Unpublished study prepared by PTRL East, Inc.
             114 p.
                                       130

-------
                                BIBLIOGRAPHY
 MRID
                    CITATION
 42885201
 42987601
 43585500


 43895801
43909802
43929801
43929802
44048901
 Kuo, A.; Nishioka, L.; Bautista, A. et al. (1993) Freezer Storage Stability of
 Terbacil and its Metabolites (A,B, and C) in Apples, Mint, Sugarcane,
 Blueberries, and Soil: Lab Project Number: AMR 1720-90: 235W-1: 235-W.
 Unpublished study prepared by PTRL West, Inc. 70 p.

 Malek, D. (1993) Combined Chronic Toxicity/Oncogenicity Study with
 DPX-D732-66 (Terbacil) Two Year Feeding Study in Rats: Lab Project
 Number: 9027-001: 453-93: 18260. Unpublished study prepared by E. I. du
 Pont de Nemours and Co. 1430 p.

 DuPont Agricultural Products (1995) Submission of Environmental Data in
 Support of the Terbacil Registration Standard.  Transmittal of 1 Study 1

 Heldreth, K.; McKelvey, R. (1996) Influence of Terbacil on Seed Germination,
 Seedling Emergence, and Vegetative Vigor of  Several  Terrestrial Plants:
 Supplement No. 1: Lab Project Number: AMR 2073-91: MR 10421.
 Unpublished study prepared by DuPont Agricultural Products. 414 p.

 Hughes, J.; Alexander, M. (1996) DPX-D732-66: Influence on Growth and
 Reproduction of Navicula pelliculosa: Lab Project Number: AMR 3723-95:
 10376: 19-03-1.  Unpublished study prepared by Carolina Ecotpx, Inc. and
 Haskell Lab  for Toxicology and Industrial Medicine. 62 p.

 Thompson, S. (1996) Terbacil: Influence on Growth and Reproduction of
 Lemna gibba G3: Lab Project Number: AMR-3484-95: HA-95-113: 10376.
 Unpublished study prepared by Wildlife International Ltd. and DuPont Haskell
 Labs. 51 p.

 Thompson, S. (1996) Terbacil: Influence on Growth and Reproduction of Two
 Select Algal Species: Lab Project Number: AMR 3483-95:  HA-95-114:
 112Arl42. Unpublished study prepared by Wildlife International Ltd.  and
 DuPont Haskell Labs. 62 p.

 Lee, P. (1996) Magnitude of Residues of Terbacil in Apples Following
Applications  of Sinbar Herbicide at Maximum Label Rates: Lab Project
Number: AMR 3111-94: 560W: 560W-1.  Unpublished study prepared by E. I.
du Pont de Nemours and Co. and PTRL-West.  85 p.
                                       131

-------
44048902    Lee, P. (1996) Magnitude of Residues of Terbacil in Apples and  Their
             Processed Fractions Following Applications of Sinbar Herbicide:  Lab Project
             Number: AMR 3112-94: PG8043: 561W. Unpublished study prepared by E. I.
             du Pont de Nemours and Co.;The National Food Lab., Inc.; and PTRL-West.
             114 p.

44048903    Lee, P. (1996) Magnitude of Residues of Terbacil in Sugarcane Following
             Applications of Sinbar Herbicide at Maximum Label Rates: Lab Project
             Number: AMR 3113-94: 562W: 562W-1. Unpublished study prepared by E. I.
             du Pont de Nemours and Co. and PTRL-West. 81 p.

44048904    Lee, P. (1996) Magnitude of Residues of Terbacil in Sugarcane and Its
             Processed Fractions. Following Applications of Sinbar Herbicide:  Lab Project
             Number: AMR 3114-94: HSPA 5509: 563W. Unpublished study prepared by
             E. I. du Pont de Nemours and Co.; Hawaiian Sugar Planters' Asso. and
             PTRL-West. 106 p.

44080101    Charlton, R.; Bookhart, S. (1996) Metabolism of (carbon-14) Terbacil in
             Sugarcane: Lab Project Number: AMR 3346-95.  Unpublished study prepared
             by Dupont Ag Products.  51 p.

44150201    McCann, J.; Pitcher, F. (1972) Fish Toxicity Laboratory Report:  Toxicity of
             DuPont Sinbar Terbacil Weed Killer to Rainbow Trout: Lab Project Number:
             528: 043423: 69476. Unpublished study prepared by US EPA. 9 p.

44177101    Lurvey, E. (1996) Terbacil: Magnitude of Residues on Blueberry: Lab Project
          .   Number: 549W: 05985.95-PTR03: 05985.95-MI13.  Unpublished study
          "  prepared by PTRL West, Inc. 421 p.

44177102    Lurvey, E. (1996) Terbacil: Magnitude of Residues in Caneberry: Lab Project
             Number: 551-W: 05469.95-PTR02:05469.95-OR23.  Unpublished study
             prepared by PTRL West, Inc. 279 p.
                                       132

-------
                   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 hi Section in 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 hi the manner
             specified by this Notice (see section ni-D).

      If you do not respond to this Notice,  or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your produces) subject to this Notice will be subject to suspension.  We have provided a list of
all of your products subject to this Notice 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), 7 U.S.C. section 136a(c)(2)(B). Collection of this

                                       133

-------
information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-99).

       This Notice is divided into six sections and 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
Section II
Section HI
Section IV.
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants' Obligation to Report Possible Unreasonable Adverse Effects
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 Reregistration
      5 -    List of Registrants Receiving This Notice
      6-    Cost Share and Data Compensation Forms
SECTION I. 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 produces) containing the subject active ingredients.
SECTION n. DATA REQUIRED BY THIS NOTICE

n-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.
                                        134

-------
 II-B. SCHEDULE FOR SUBMISSION OR 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).

       AU 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(s), or any other agreements entered into
 with the Agency pertaining to such prior Notice.  Registrants must comply with the
 requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
 products.


 SECTION m.      COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

      You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3  on the four Data Call-In forms (Attachments 2 and 3).
                                       135

-------
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY

       The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a 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 ffl-C. A discussion of options relating to requests for data waivers is
contained in Section ni-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 hi 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 Fprm(s). If you
choose this option, these are the only forms that you are required to complete.

                                         136

-------
       If you chose to voluntarily cancel your product, further sale and distribution of your
 product after the effective date of cancellation must be in accordance with the Existing Stocks
 provisions of this Notice, which are contained in Section IV-C.

       b.     Use Deletion -

       You may avoid the requirements of this Notice by eliminating the uses of your product
 to which the requirements apply. If you wish to amend your registration to delete uses, you
 must submit the Requirements Status 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 me ultimate source of the active ingredient hi your
      product subject to this DCI must be in compliance with the requirements of this Notice
      and must remain hi 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

                                         137

-------
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.

       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 in-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 hi Section in-D. 1. 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 hi Section ni-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,

                                          138

-------
 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 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 produces) containing the active ingredient that is the subject of mis 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.
                                         1                                  '
       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 specificdata
 requirements differ  slightly from those options for fulfilling generic data requirements.
 Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
 product specific data requirements. It is important to ensure that you are using the correct
 forms and instructions when completing your response to the Reregistration Eligibility
 Decision document.                                                                    ,
       c.
Request for Product Specific Data Waivers.
       Waivers for product specific data are discussed in Section III-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response 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
                                         139

-------
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.

m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       1.     Generic Data

       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 hi this Section. The options are:

       (1)    I will generate and submit data within the specified timeframe (Developing
             Data)
       (2)    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing)
       (3)    I have made offers to cost-share (Offers to Cost Share)
       (4)    I am submitting an existing study that has not been submitted previously to the
             Agency by anyone (Submitting an Existing Study)
       (5)    I am submitting or citing data to upgrade, a study classified by EPA as partially
             acceptable and 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 hi 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 hi 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 hi 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 hi Section II-C. If the Agency rejects your protocol you will be
notified hi 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.
                                        140

-------
        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 generate or otherwise address the requirement for the study. In addition to the other
^formation 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 registrant1 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.

                                     '   141

-------
                                                                              I
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
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  hi 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.

                                         142

-------
       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 GFR
              Part 160. As stated in 40 CFR 160.3 'Raw data'  means any laboratory
              worksheets, records, memoranda, notes, or exact copies thereof, that are the
              result of original observations and activities of a study and are necessary for the
              reconstruction and evaluation of the report of that study. In the event that exact
              transcripts of raw data have been prepared (e.g., tapes which have been
              transcribed verbatim, dated, and verified accurate by signature), the exact copy
              or exact transcript may be substituted for the original source as raw data. 'Raw
              data' may include photographs, microfilm or microfiche copies, computer
              printouts, magnetic media, including dictated observations, and recorded data
              from automated instruments." The term "specimens", according to 40 CFR
              160.3, means "any material derived from a test system for examination or
              analysis."

              Health and safety studies completed after May 1984 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.

              You must certify that each study fulfills the acceptance criteria for the Guideline
              relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
              Technical Guidance and that the study has been conducted according to the
              Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
              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.
      c.
                                        143

-------
       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 hi 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

       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-rninimum." For ecological effects studies, the

                                         144

-------
 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

       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)

       (2)

       (3)
       (4)

       (5)

       (6)
              I will generate and submit data within the specified time-frame (Developing
              Data)
              I have entered into an agreement with one or more registrants to develop data
              jointly (Cost Sharing)
              I have made offers to cost-share (Offers to Cost Share)
              I am submitting an existing study that has not been submitted previously to the
              Agency by anyone (Submitting an Existing Study)
              I am submitting or citing data to upgrade a study classified by EPA as partially
              acceptable and upgradeable (Upgrading a Study)
              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 ffl.C.l,  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
m.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.           	
                                         145

-------
Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section ni.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 ni.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
m.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
Section IILC.1., 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 (ni.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 requirements) 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.
                                         146

-------
       .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.

        (iii)  Total direct production cost of produces) containing the active ingredient
 by year for the past five years. Include information on raw material cost, direct labor
 cost, advertising,  sales and marketing, and any other significant costs listed separately.

       (iv) Total indirect production cost (elg. plant overhead, amortized plant and
 equipment) charged to produces) containing the active ingredient by year for the past
 five years. Exclude all non-recurring costs that were directly related to the active
 ingredient, such as costs of initial registration and any data development.

       (v) A list of each data requirement for which you seek a waiver. Indicate the
 type of waiver sought and the estimated cost to you (listed separately for each data
 requirement and associated test) of conducting the testing needed to fulfill each of these
 data requirements.

       (vi) A list of each data requirement for which you are 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

                                    147

-------
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 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 hi 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 product(s), 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

                                   148

-------
       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.
SECTION IV.
        CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
        NOTICE                    ~~    ~	
IV-A  NOTICE OF INTENT TO SUSPEND
                                                   • -  . :        -  x
       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.
      5.
      6.


      7.

      8.
 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:         ,
 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).

 Failure to submit  supportable certifications as to the conditions of submitted
 studies, as required by Section IH-C of this Notice.

 Withdrawal of an offer to share in the cost of developing required data.

 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:
                                        149

-------
             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 hi 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.

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 hi 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.

rV-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.

                                         150

-------
        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 produces)
 which may be suspended for failure to comply with this Notice should be permitted, you have
 the burden of clearly demonstrating to EPA that granting such permission would be consistent
 with the Act. You 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 canceDation of your produces) as a response to this Notice
 and your product is in full compliance with all Agency requirements, you will have, under
 most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
 distribute, or use existing stocks. Normally, the Agency will allow persons other than the
 registrant such as independent distributers, retailers and end users to sell, distribute or use
 such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
 voluntarily cancelled products containing an active ingredient for which the Agency has
 particular risk concerns will be determined on a case-by-case basis.

       Requests for voluntary cancellation received after the 90 day response period required
 by this Notice will not result in the agency granting any additional time to sell, distribute, or
 use existing stocks beyond a year from the date the 90 day response was due, unless you
 demonstrate to the Agency that you are in full compliance with all Agency requirements
 including the requirements of this Notice. For example, if you decide to voluntarily cancel
 your registration six months before a 3-year study is scheduled to be submitted, all progress
 reports and other information necessary to establish that you have been conducting the study in
 an acceptable and good faith manner must have been submitted to the Agency, before EPA
 will consider granting an existing stocks provision.
SECTION V.
REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
       Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have  from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement'
continues as long as the products are registered by the Agency.
                                         151

-------
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,
                                Lois A. Rossi, Director
                                Special Review and
                                 Reregistration 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
             Generic Data Call-In and Product Specific Data Call-in Requirements Status
             and Registrant's Response Forms with Instructions
             EPA Batching of End-Use Products for Meeting Acute Toxicology Data
3-

4-

5-
6-
             Requirements for Reregistration
             List of Registrants Receiving This Notice
             Confidential Statement of Formula, Cost Share and Data Compensation Forms
                                        152'

-------
 TERBACIL DATA CALL-IN CHEMICAL STATUS SHEET

 INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have product(s)
 containing TERBACIL.

       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 reregistratibn of
 TERBACIL. This attachment is to be used in conjunction with (1) the Product Specific Data Call-
 in Notice, (2)  the Product Specific Data Call-In Response Form (Attachment  2), (3) the
 Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
 Products for Meeting Acute Toxicology Data Requirement (Attachment 4),  (5) the EPA
 Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and
 (7) the Cost Share and Data Compensation Forms in replying to this TERBACIL Product Specific
 Data Call-In (Attachment 7). Instructions and guidance accompany each form.

 DATA JREQUIRED BY THIS NOTICE

      The additional data requirements needed to complete the database for TERBACIL are
 contained in the Requirements Status and Registrant's Response. Attachment 3.  The Agency has
 concluded that additional data on TERBACIL are needed for specific products. These data are
 required to be submitted to the Agency within the time frame listed.  These data are needed to
 fully complete the reregistration of all eligible TERBACIL 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 Karen Jones at (703) 308-8047.

      All responses to this Notice for the Product Specific data requirements should be submitted
      to:
            Karen Jones
            Chemical Review Manager Team 81
            Product Reregistration Branch
            Special Review and Reregistration Branch 7508W
            Office of Pesticide Programs
            U.S. Environmental Protection Agency
            Washington, D.C.  20460

            RE: TERBACIL
                                       153

-------
TERBACIL DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

      You have been  sent this Generic Data Call-In Notice because you have product(s)
containing Terbacil.

      This Generic Data Call-in Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of Terbacil. 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 2), (4) a list of registrants receiving this DCI  (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), and  (6) the Cost Share and Data Compensation Forms in
replying to this TERBACIL Generic Data Call In (Attachment F).  Instructions and guidance
accompany each form.

DATA REQUIRED BY THIS NOTICE
      The additional data requirements needed to complete the generic database for Terbacil are
contained in the Requirements Status and Registrant's Response, Attachment C.  The Agency has
concluded that additional product chemistry data on Terbacil are needed. These data are needed
to fully complete the reregistration of all eligible Terbacil 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 Emily Mitchell at (703) 308-8583.

      All responsades to this Notice for the generic data requirements should be submitted to:

            Emily Mitchell, Chemical Review Manager
      Reregistration Branch I
            Special Review and Registration Division (H7508W)
            Office of Pesticiafde Programs
            U.S. .Environmental Protection Agency
            Washington, D.C.  20460
            RE: TERBACIL
                                        154

-------
1-



c

H
CU
n
O<








































^
O
u
EH
PL,
^5
Pi
Q








i

M

ouv co
*-o eu
•o i ? —
CU OO Q.
> i*-r*- x
O OO Ul
<- CMOJ
a. — •
Q. • ra
E S !
c ' £-
L- CQ Q.
o sc a.
U. 0 <£





















o

0)
tn
^
a
O
-H
4-> 0
O W)
ntal Prote
D. C. 204
N RESPONSE
CU - H
IS *
r-4 W |"i
° ^ 1^
-H a S
g "jj ^
H CQ . EH
nS rtj
CQ [2 Q
Q)
4J
td
CQ

•o
-H
g





















-E
o
<*-
CO
JE



o
"8
4J


1
§


CO
L.
O
c
o
.e:
w
^
§:
CO
5
n
\
attached instruct

D
>.
j
)
0
o
!.
O
CO
I
)

if
•u ra
: co
•- CO
<- o
Q. U
u S.
L '
•> CO
1 4J
eo eu
! CU
• CO
wl
: o
"C
i
£ ra

z co -
~^-






o
H
; « H
"o ft
|"
ri
c t>
ra Q .
«! O
ra PJ
1 •




















H
•H
U
§1
«: O\
Hi fO
co o
3 o

(V









O
0
CQ O
CQ 0
CO W °
i»SQ
S ^ Q X
3 ft < X!
"O *^-*
CJ pr] ^.
§ W >H
ra H ct! EH
^•Oj CQ O
f-H o o
(j CQ f+ H

•
















(0

CO

o
H-

U
S.
eo
•M
O

O
Q.

•














ra
•M
ra
o
u
'£
•s
s
•o


C 01 CO
CO Q. J= *J ' •
DOC
A tn (g eu
34J S CO
(U *•* QJ «•
.c ro t- 4^
C *J M- C
ra eu g^ to
co s- *J eu 4->
•— _CO Di CO
•K +J 0 = '5>
o ra "o cu
3 co mjuo:
0 O C +J -D =
D. E 4J ra a
eu eu c co
>> 0) I- CU CO £
*", oi'5 E 5 c
• ra D" t- ra c/
^2 cu o +•» a
i>» "— t- •*- e/> o:



' "O
"O CU CO
c CL j: +j
ra zj o c

a. -MEW
3 eu 4-* cu ^
£ .c ra t- <-•
ra ** eu '3 ,ra
CO S- ** CU -M
— CO 0£ CO
H- C = ••-
<-» ** O D)
u ra •DO
3 co co eu ^
•a 4J — •
O O C -M T3 S
t. *j eu •«• c •
a. E +j ro eu
cu eu c co
>. cu i- eu eo c
z -t- •— 3 o
• ra cr t- ra co
ra eu o 4J o
~ C-H-COO:
0 TJ
— CU TJ
t- 
s "5 •*•* "o
KIP- cu ra ~»
2 ra S § 1
4-> O 4-* 0
S^S^S g-
o g"8w,£
4-» E .C CO
en o 4J co
eu t- o c ~
CU ••- 4J CU *-»
- 3 4-> E C
n c^ ra cu ra
ra u i- i_
c- eu ••- 4->
" ra £ 3-2
a* S e S 9
000=0:

4^ •
O C 2
eu i o
: ""S 'ra^
1 CO D) t. -D
3 C CU
ra ra «- < 4J
o a. co
5 cu eu lu •!-
i-0.^ en"1
E C 4J O C.
•- O U £. CU
ra — ra 3 .a ,
i g. eu co 5
| g 4J ^ffl
Ul C 4J O
CO '5 E *J
• 4J 4^ o ra
o ra .a t. t.
O O O H- 4J

1 1
CO C
O — 3
4J CO D) — •
.»- eu o
•ss «- >
•— *J C •
3 « S .2 2r
§o ra 'tl
L. ^' ra
in o Q. -u *<



li
o —
t— 4J

Q. CO
til ••-
O)

•^ G£









-




-























•



. -
\


J3







s !
1 . ' ' ' , . ' •
1 , ;
2j
3 ' . '
g '

^4
^ 	 : 	 •

















OJ
+•*
CO "
0
•



'








•M
O 0)
oJ c
— * o
g. CO
S|
1-
ra »
il ••
lo14-
3* •
o cu
•?s
- ra
§!
4-» ' C
CU CL
".g
-M >-
|J
U C
CO (U
. 4-> O A)
CO -M >
CO . ••-
— • CO CO
CO 4->
•o g S
ra TJ cu
gj 1
O CO ££

. 'eo
'TO >.
4J — 3 ra
c g jo Q.
cu ^ o cj
1 . .
ra >» ja H-
4-* c ra o
co ra u
««.= J5
-c ra Q- 4J
ra cu c. -D
*"*"§ "c *"
X— • 3 0)
•»- 3 u
' •- 0 .c 3
'«- ^ o ra
CU O ^2 C
u ra ra
-• •-> o 
-------

H

ni
0

H
0)

CM






































{H
CM

o
u

E-i

fa
(=«

tf
Q




£
1
o
1
o
Otn «
oo £1
•n ii**.
§ gg g-
2 88 m

t 0 1
z S
P c-















s^
0
a
0)


a
o
•H
jj
|ii
*«l
•-» 6 9
ttf . «

C< 3
1 « J

0 -S Ja!
_J O} rj
* fl ^^
^ i i
C* r"* ^^
pq "S Ej
m i§| Q
Q) ^
ttJ
jj
TO
•3
0)
4J
•H
S























E
,2
CO
jc:

g
I
CO
i
g

1

Q

"c
m
J=
**

^
1
CO
"g
s>
nched instructi
4->
.
4J CO
C CO
•-- CO
I- CU
O. 0
a»
o
K **"
§r **•
CO O
CO 01
O -C
-* CO
CO 2
2 4V
h« •—
Ml
& «
Z CO
—• =>








u
a
"o
1 a
£• u
•Q OJ
C M
" &
•£> H
S CD

.
K)













H
O
H l>
-H tN
O H
(ti 0
^} 1
,g|
IL
3f. C\ oo
So St.
c5o g "
CM














O
O
TO 0
a HO
OJ ^j orf
5 ^ Q
"* 3 § >c|

§ 0 H -
§ W SM
c" >-3 IH M

cf § O O
. TO S 53
T















CO
4-1
CO
o
'o
8.
CO
*J

c.
a.


N"


















e
a
0
cu
c
cu
 3 CO
CO H- 4-» »a> L. a> w c
• co a* L. a co
_Q at O XJ (U
Pi- UvSJjcZ


•g TJ
C Ctt CO
CD a. .c 4-*
3 o c
Q- 5E CO O
§4-> e u>
CU 4J CU —
§ ** cu '5 a
X-C V t-
CO **- 4-» CU 4J
t>i§?'§
3 S wJicE
O O ^ 4JT3S
u 4-> aj — £ •
a. E 4J ca cu
cu 5 c ca
5»eu u cu ca c
It-— 3 O
o) p E 4J a.
• ca trc. co ca
JCO CU O 4-> »- CU CO *"•
H- CU
ca ca E ca u
'£ * o i5 o
ca ca *»- co CL
0) 4J 4J CO
CTJ eo cu
o v cu ae
6b. I agree t
Data requirem
on the attach
"Requirements
Registrant's


.s g. i

go HI?
o .« n c. -n
OJ CO •— < 4->
o £ co
?_S 11 ^ "*"
1 C4J 0^
JS'B ™il
"o Q.CU to §
§§£ g,
X .C C
111 C *< O
" 25 §io
CO CO ^2 t- t-
•O Q OH- 4->


o .£§
•w ca co—
^s2:§
CO 4^
'S—oo^.
" c'So'II
• CO £. t» CO
in u Q.4J 4->




ll
U 4-*

< -M
a. co
»
4-- C
cu a.
CO Q)

i ^
J= 4J
a g

4-* U 0}
"2 -B
^* H
•o c g
C— CO
OJTJ cu
E S Q.
t.— • cu
o co en
e -o
.2,, a
5° -
cu o
C CO -C
" 0"cO 3
S X CO
we- £
I §J §
m ^3 m ^
(0 ^**fi **•
4-» C CO O
CA CO U
01 4J^ — '
c 558: r
O 4J CO t—
4^ co cu c. -a
CD .e o> cu c
•i^ X-5 3 cu

4-> — o j: 3
L. 4-1 C 4-1 4J
o cu o2 c
o co o>
co — — o 'eo











L.
•8
i
cu
c
o
-C
a.
^




































o
CD
C
U
c

"
o

sc
o


-------
  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 Reregislration 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 rnaintaining 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; arid to the Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
                                        157

-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Iteml.       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 hi the  subject product. By
             electing this exemption, you agree to the terms and  conditions of a Generic Data
             Exemption as explained hi 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 hi your product.

             Typically, if you purchase an EPA-registered product from  one or more other
             producers (who, with respect to the incorporated product, are hi 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
                                        158

-------
             are registered), you may not claim a Generic Data Exemption and you may not
             select this item.

INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in              "             '•	"—
Item 6b.
Item 7a.
Item 7b.
 ON THE GENERIC DATA FORM:  Check this Item if the Data Call-in is for
 generic data as indicated hi 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.

 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."     .

 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 spurce(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.
                                      159

-------
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.   '
                                       160

-------
            8
            Ol
 0)

 n
ft
       I
        2
        a
oin

oo

SS '**•
oo ILI


 •    P
O


EH

fa

'<

ft

Q
0)   -
   ro
        CO
    CD
    4J
    •H
        CX
        M
r print i
necessary
                 .  o>
                CO  <1>
                O  .c
               —•  0)
                     /5.S
                     z  Q

- H
o rj
a rvi
                             rH
                             -H
                             O
                          J  (U
                          f  EH
                          S2 CD
                         3 o
                                         Cn
                                    W.
                                   O
                                   0
                                CQ O
                                CQ 0
                                Ed O
                  IOEH
                   "OH

                   I  W
                                   H
     I-M

    .g
    | CQ U

    ! o o
                                                  g

                                                  •M
                                                  (A 01

                                                  §1
                                                  C£ Q.
                                                 D> O
                                                 O O.
                                                 <- CU
                                                 a. a:
                                           QiOl— OCJO— 1
                                              — 
                                                                                                                         i
                                                                vo
                                                                                             CO
                                                                               VO     IjD \f> VO Xj?  '
                                                                                                                  I> H H



                                                                                                                  VD tO VO
                                                                                                                                   o 0)
                                                                                                                                   ra3
                                                                                                                                    * CD
                                                                                                                                   s-g
                                                                                                                                   CD a.

                                                                                                                                   co o
                                                                                                                                     _Q
                                                                                                                                   CO
                                                                                                                                  •M X

                                                                                                                                   S §
                                                                                                                                  E

                                                                                                                                  "5 c
                                                                                                                                  CO QJ

                                                                                                                                  4-* CD
                                                                                                                                  CO 4J

                                                                                                                                  —' 4-»
                                                                                                                                  —• CO




                                                                                                                                  CO "5
                                                                                                                                      CD
                                                                                                                                    C CO
                                                                                                                                    O —
                                                                                                                                      CO
                                                                                                                                    OH-
                                                                                                                                              0)


                                                                                                                                              4->
                                                                                                                                              CO
                                                                                                                                       8-
                                                                                                                                       a:
                                                                                                                                 £.
                                                                                                                                 O
                                                                                                                                 .C
                                                                                                                                 4J
                                                                                                                                 3
                                                                                                                                 <
                                                                                                   cog   .   ^
                                                                                                   4-> -f-  2   CO
                                                                                                   c  2  co   a.


                                                                                                   HI J^  d)   (J

                                                                                                   CO  >> J2   N-
                                                                                                   4-»  C  CO   O
                                                                                                   CO  CO  U
                                                                                                        •r-   O
                                                                                                   0) 4-> —'   —.
                                                                                                  f  CO  O.   4J
                                                                                                  4J x:  a.   T-
                                                                                                                                   CO d) C.
                                                                                                                                   -C D) (U
                                                                                                                                   4-" T3 T3
                                                                                                                                      O C

                                                                                                                                   ^ IS =»   fc
                                                                                                                                   •"• o j:   3
                                                                                                                                       0)
                                                                                                                                 co

                                                                                                                                 g

                                                                                                                      •— •— o   «
                                                                                                                                  L. ££.  O
                                                                                                                                  «)  O JJ
                                                                                                                                  0  CO

-------
cs
(U
Cn
cti
CM
CM

O

O
«!

Pi

P
    I
    o
    i
    oin  H
                  W PJ EH
                  J EH H
                  •CM CQ O

                  •^ O O
                                I
                                4->
                                CO CD


                                «? O
                                a: a.


                                o a:
                                 o
                                 u

                                UI CO
                                01 4->

                                -^
                            CO
                            CO CO
                            Q) 4->
                              IL QJOI-OtJO-I
                               t
                                .c c
                                _> 01

                                •8i
                                          03 ro 03 03 03 D3 03 03        0)0}   03 03 03 t/3
                                          iiiiiiig        u   gggg
                                          oocooocoooooooco        co co   co co co co
                                          HHHHHHHM
                                          ?r1 rri rr! rr? h. ?T> ifi ?irt
                                          88888888
                                                                   CM CM   CM A* CM CM
                                                                   63 W   w to H ftj
                                                                          Cu
                                                                          S

                                                                              O O
                                                                               r~ \J-  tu

                                                                   ir    SSlr
                                                                        
                                                                   < <   < «v Q- 0
                                                    l  i  l
                                                                     CN
                                                                   oo oo
                                                  n ^?|* LO
                                                  i   )  i
                                                 'H r-t H
                                                  co CQ co
                                                                                           a)
                                                                                           •M
                                                                                           CO
                                                                                           D)

                                                                                           8.
                                                                                           o

                                                                                           c
                                                                                           o
                                                                                             0)


                                                                                           Ic
                                                                                           M- O
                                                                                            - CO
                                                                                            ->

  
-------
OJ
M-l
 O
 0)

 nj
a,
o

a



fa



a*

p
NI
K
                  0)
                  m
                            4-> JT
                            •»- .CU
use
                           CU g CU

                           II  • —'
                             4-> CO
                          a. o"o


                             "i'5-
E
ing-use prod

he purchased p

bles.]; TEP = ty

beled. •
a
nufactu
ning to

in the ta

radiol
     o

     -8
     4-»
     3   —
    ' O    GJ
                                          .•g
                                           o
          I

           CO
                                         o c.

                                         4J CO O
                                         CO CU O
                                         3 C- TJ
                                         cr o c
                                           i-
                                                   B.
                                                   O
    CO O  C   ^x
    ... CO  O   O _
ood feed crop
d residentia
                                                                in <- o
                                                                in o t-
                                                                «- ^ o
                                                                        o    *z   H,
                                                                       •4-    CU    3^
      o
      H-
   —• C TJ
    CO O O
   •— C O
    1-    M-
   4-> U
      S— L.
      4-* O
    C- CD O
    I- 3 TJ
  .  CD O- £
   I- < •-.
                                                 TJ
                                                 s
es are
CU
a.
X


'c
CO
ood c

ood In

outdoo
[The
=
K M

data perta

identified
ingredient
 SS--C-.
^ CD O  CD   ••
 « r c '^   03
 4) 4J o  c   Q}
!.• CO •»-  (I)  '
 t. CU 4J /S
 O C- CO •"

fill
U i  i   i
 0) 
                                           O O
                                           J= CU
                                           CD a.
                                        g    a
                                       •43    g
                                        3    T)
                                                                                                                                              1
                                                                                                                                            §
                                                                                                         o
                                                                                                         tn
                                                                                                         cu
                                                                           a.

                                                                           o
                                                                   u E
                                                                c.  co -S
                                                                CD S- _.
                                                                i:  3
                                                                4J  C «*-
                                                                  •o §

                                                                     '
                                                                        •     -

                                                               111   «
                                                                  CU 4*«  O

                                                                   in

                                                                 "5 CO «-
                                                                  CU 4-i   .
                                                                 t. <« eo
                                                                                o>
                                                                                  CU    V flj

                                                                                  I    II
                                                                                  c

                                                                                 '2
                                                                                  «9
                                                                                        'o
                                                                                        «
                                                                                                        u
                                                                                                        CO
                                                                                                        CO

                                                                                                        u


                                                                                                        £
                                                                                 "8    II
                                                                                 -
                                                                          s    :    -
                                                                            -
                                                                                                                     -r
                                                                                                                      a   -
                                                                                                                     2 "
                                                                                                                     *^M
                                                                                                                                            Q.

                                                                                                                                            CD
                                                                                             t


                                                               i


                                                                              l

                                                                                     II    1
                                                                                     "



                                                                                                             S
                                                                                                             $
                                                                                                               II
                                                                                                               Eg-


                                                                                                                      cj!
                                                                                                                                             c
                                                                                                                                             CD

                                                                                                                                            _
                                                                                                                                           o

                                                                                                                                           CM


     • —  ~ v>    ••- at •*-—•—•
       T -CX •—  C    t-  N .Q Q.    fl)
    —  J UJ    O t- CU — .^ X   —• '
    CU —*    CU    O D.TJ 4J CU    ~


                                                                                                                  >.
                                                                                                                       5
                                                                                                                                        S  »
                                                                                                                                        D)  O
                                                                                                                                        CO  8
                                                                                                                                        CO  !_


                                                                                                                                        01  fe
                                                                                                                                        CO  U
                                                                                                                                        0} CO

                                                                                                                                        u c_
                                                                                                                                        CU CU
                                                                                                                                  U    CO CO
                                                                                                                                        cu cu
                                                                                                                                  t-    4J 4->
                                                                                                                                  W    TJ TJ
                                                                                                                                  K     U u


                                                                                                                                  o     cr cr

                                                                                                                                  |  '   £ 2
                                                                                                                                  i

-------
oa

o





Q)
tn

Cu














































t
CM

O


t*



E"1

&JJ
^
«*s
P4
Q


























CQ







^i lv
o S


a) gi
f3* H

§ 1 d
•H a o
4J 3 (ti
oo a 43
0) vo g ^
o o H IH
5-J C^ fh
CM °
• -j 0^
H o S m
td go
4J . « 0
SP CO
Q} g; ••
3 £jT EJ
o o H ro
M 4J FJ fe
•d 21 S ^
> P K ID
Cj -r 1 ^^ Q
pq £j gj ro
DQ Q
ro nS 3£
0) S »V|
4J GO)
 [S
(U '*«
tl M
n ca
O Ej




r^
i



















co o
• CU — »
CU «•— "T3
V U O
co ••- j:

3 Si
••- Q.
t- t- C
ro o co
Q. J=
•x. •»-» «
0 ° 0
8 "H 8
fe 0-S
CO CO C.
I- Q.
t- 0
O -M *>-
•— O
• XI
S.i- 4J
J= C
0 C CU
CO "~ Q.
U CU O
CO CO — *
XI CO CU
3 t- >
CO CU CU
0) CO
— CU t.
•— CO
4J .^ H-
CO — •
— • 0 >.
O JC 0
> ° §
» t- D)
CO 0) CO
CO -C
en -MCU
O J=
CD O .C
H- 4^
i "g'5
L. 4->
cu t- o
4-* CJ
CO CU
e xi 2
•-'§.
3 ° S e
01 CO CO O
CD C D> -M
c_ o t. c/i
±s°»
^ T3 O — •
2gM-CO
0) O "D «
CO 

° 3 S"5
St.1-*.'
.S 3 .2 g
4-» O H-
•*• O *^H-
TJ U CO

. S c o ^
co i. cu
•M t- CO JC CO
O CU CU O t-

•»- 3 O T3

t- t- "D
C 0 3 C 0
O CO CO 4^
•C»_-8. .^
CO O X U CO
4-» CU -^ ••-
•J- CO _^ C 4J
C- CO Cg L. CU

*~ « t- O O
— ' c eu xi o.
** SO CO CO
>-^ E T3
en 4J oi ""D
• T3 0 4J CU 0)
,JJ 3 CO 4-> 4->

w CO t- CU CO 4J
cu Q" ^ ^ c

COS- C CO
?i C T3 13 ^ CO
4^ cu cu cu — • jc
n *• <- >- .o
co -
CO CU
+J t_

co 1o
cu -^
t- o
cu
cu o_
JCZ CO
s~
4J O
CO
5g
"SIS
11
O -r-
4J L- .
c o
CO H-
_>._«
•Q t-
ro ai
§£
CO C-
CO U
cu
(.  CO
L. •
O 0

CO
g .°
5 & . "•:•/..
U CO i .'". A .'.'•,,

CO 0) . .'
cu c — ..••:.• s

^3 •*• ' -'•.'"
5 o t! : • '.'
CO "- CU
4J O •
•S3X .:"
•— ja
o cu ' .
••- Q. CO
4J UI 3 '
l"
5 J! °
s»l •

c —
£_ i^ L.
O 4-> 4-1
«•- CO CO
c. cu cu
Q.H- I.
to























1
1
1
1

1
1



























•



•^
'• J1"*


:'-l '
. . *•

•'••-


."








-------
H
lf_f

H

0)
Oi
nJ









































>H
O
U
EH
fa
~"
04
Q




•?
I
h-N- °
oin co
*-o cu

> SS x
O OO Ul
t- (MCM
•N 1
t. CO O.
O I SL
U- O «t






I







£*"i G9
U 01

Q) O-
tp 01
*C 01
H
O
•H 01
4-> »
S'g §
g o g
CU ^ 01
. H
 .If £
fl J3 «<
w CQ f*
(6 V*
m &
0) ** 01
w S
•d 5
(U H
i) £3
•H S
g a
~



















g
o

*5
c
o

!
cu
1
c
o
i
o
1

.c
•M , •

^
&
3
•g
CO
1
4-*
O
3
i_
**
CO
c
1
CJ
CO
cu
J=
-
1 '
is

S"

s
8
°-
_^
c
•M CD
C «
Is
L. C
O
s-
*> "a.
84J
CU
CO CU
2 -g
a.
.. "3
en c

2 T
11
CO CU
^ tf



-




u
0
H-
0

§LO
i- H
-g Oi
(g ^4
S H
SO
.













H
O
t^
H
rH O
•H
U a.
n$ g
•sg 1
"8
<° "S ~
» O% o o
n "E S
J§ J'*
B
N









o
o
CQ 0
CO O
co « 0
« r" Pi
O ^^ (^
L. fC| l_l
9|9H
"S o iu
a CJ S ~
1 : w £
C J EH H
&'& CO U
§,^ O O
Cfi ^5 ^R
T"





«
CO
4-*
M S
9$.
o: Q.
• 8
one



1

"~ 1

OOU.


cu
<-> c
SCO
^J

KM








C
cu.c.
U) CU
= t!
• CO
-00.
Kl
CO
4) V
c. t_
O) O C^
o a.
«_ CU >

-.
f\ ^Y^t^-fV TO *








O
f
CO
in





~* i
• In
1 ^0£Z
• •
';''"' "
'^ ^ . * • '


f ff •• , ,


<• •• " -

. ' ' • .
, . . . .
"• •
. + . » «
CQ t& QQ {ft 03
0 0 O O O


^ f - ,
-. .. '- ..
CM f» H r4«N



f f • , •

iliis
i"~ i* • «^ *" ^~ , *
-, ' • - =

ff


• •

' , .
hD*^^^
'pTj f*fl pQ 03
i4j rtj t^ |4| ^D ' .
, c
' * " .' •



>H>t >H .

^


^ * . ' .
'-. ' '
•y .....
* ' -•'..-
^ w ja ' . ' *
« b+ CD
••- -O 4-»
*S U V **- '
O* TO Bj ">«• •«" ' ' ' • .
«$£"«•§'
w ••- "t »» I.
> > CO >•» CB

r ' r ' ' ' *

'••''• ' ' '• "'

^Jjg^tijQ:
rH t-t «N .
C 9
r" u
o c
CO 92
•MS CU
aj -M >
CO —
—•CO CO
<" _ -g
•a c 01
:! 1
I_— ' CU
o ca a:
a1 "S
.^ L. N
.CO "-
4J L.
0) 0
c co j:
O — * 4->
C8 3
CUH- <
g >. ca

-------
166

-------
    Instructions For Completing The "Requirements Status and Registrant's Response
             ,   Forms" For The Generic and Product Specific Data Call-In
 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 yon have already voluntarily cancelled this
        product. For these cases, please supply all relevant details so that EPA can ensure mat its records are correct.
 INTRODUCTION

       These instructions apply to the Generic and Product Specific "Requirements Status and
 Registrant's Response Forms" and are to be used by registrants to respond to generic and
 product specific Data Call-in's as part of EPA's reregistration program under the Federal
 Insecticide, Fungicide, and Rodenticide Act.  If you are an end-use product registrant only
• and have been sent this DCI letter as part of a RED document you have been sent just the
 product specific "Requirements Status and Registrant's Response Forms."1  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 DCF) 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 fillingout 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.
                                           167

-------
     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 HI of the Data Call-in Notice, 90-day progress reports are required for
             all studies.

             If an asterisk appears in Item 5, EPA has attached information relevant to this
             guideline reference number to the Requirements Status and Registrant's
             Response Form.
                                      168

-------
     INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
                       REGISTRANT'S RESPONSE FORMS"

 Generic and Product Specific Data Call-In
-Item 6.
Item 7.
 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

 ON BOTH FORMS:  This item identifies the code assigned to the substance
 that must be used for testing. A brief description of each code follows:
            EUP
            MP
            MP/TGAI

            PAI
            PAI/M
            PAI/PAIRA

            PAIRA
            PAIRA/M
            PAIRA/PM

            TEP
            TEP	%

            TEP/MET
                   End-Use Product
                   Manufacturing-Use Product
                   Manufacturing-Use Product and Technical  Grade Active
                   Ingredient
                   Pure Active Ingredient
                   Pure Active Ingredient and Metabolites
                   Pure Active Indredient or Pute Active
                   Ingredient Radiolabelled
                   Pure Active Ingredient Radiolabelled
                   Pure Active Ingredient Radiolabelled and Metabolites
                   Pure Active Ingredient Radiolabelled and Plant
                   Metabolites
                   Typical End-Use Product
                   Typical End-Use Product^ Percent Active Ingredient
                   Specified
                   Typical End-Use Product and Metabolites
                                       169

-------
             TEP/PAI/M

             TGAI
             TGAI/PAI

             TGAI/PAIRA

             TGAI/TEP

             MET
             IMP
             DEGR
             *
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active  •
Ingredient    Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites
Impurities
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 Reregistration 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 hi 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 hi the Data Call-In Notice and that I will provide the protocols
                   and progress reports required hi 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.
                                        170

-------
                     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.

 Options.     ON BOTH FORMS:  (Offer to Cost Share) I have made an offer to
              enter into an agreement with one or more registrants to develop data
              jointly. I am also submitting a completed "Certification of'offer to Cost
              Share in the Development of Data',' form. I am submitting evidence that
              I have made an 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
             thathas been previously classified by EPA as acceptable, core, core
                                  171

-------
             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.

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
                                  172

-------
Item 10.



Item 11.

Item 12.
       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.

ON BOTH FORMS:  This item must be signed by an authorized representative
of your company. The person signing must include his/her tide, and must initial
and date all other pages of this form.                              >

ON BOTH FORMS:  Enter the date of signature.

ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.             '
Item 13.      ON BOTH FORMS: Enter the phone number of your company contact.
          ^
          may vrah to report tfaatyour product has already been trarnfcncd to another company orthatyou tove already v
                                        173

-------
EPA'S BATCHING OF PRODUCTS CONTAINING TERBACEL AS THE ACTIVE
INGREDIENT 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 reregistration of products containing the active ingredient Terbacil
(5-Chloro-3-tert-bu1yl-6-methyl-uracil), the Agency has batched products which can be
considered similar in terms of acute toxicity. Factors considered in the sorting process include
each product's active and inert ingredients (identity, percent composition and biological activity),
product form (liquid, paste, solid, etc.), and labeling (e.g., signal word, precautionary labeling,
etc.).

  Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.

   Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute lexicological studies to represent all the products within that batch.
The registrant has several options to participate with all or some other registrants, or to deal
only their own products within a batch, or to generate all the required acute lexicological studies
for each of their own products.  If a registrant cho'oses 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. TRB must
approve any new formulations (that were presented to the Agency after the publication of the
RED) before data derived from them can be used to cover other products in a batch. Regardless
of whemer 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, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
                                          174

-------
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.
Table 1 displays the batches for the active ingredient Terbacil. All active products containing
Terbacil were placed into Batch #1.
                                  Table 1.
: - ;-,
1
. 'It^s&sfckia, f
Steber,
352-317
ID80000900
KY81001000
OK92000900
OR80002100
OR92000300
OR92001600
PA90000300
VA90000400
WA80001000
WA920024QO
WA93000700
:;, - BsF^ctA^HwiagreasK'
Terbacil go%
Terbacil go%
Terbacil ' 80%
Terbacil go%
Terbacil go%
Terbacil gO%
Terbacil 80%
Terbacil gO%
Terbacil go%
Terbacil go%
Terbacil gQ%
TerbacO gO%
"• "," ' *
':,""' Form, '"*
powder
powder
powder '
powder
powder
powder
powder
powder
powder
powder
powder
powder
                                          175

-------














0)
u
•H
Jj
i
«
H
3
OS
4J
nJ
Q

m
-H
S
rt
0)
to
(Q
JJ
jj
m
-H
Cr
S

3
(LJ
0
1 1
ra
-H
i-S















































-H
0
y
1

1
t
vo
I
o
O
2
O
1
in
-H iH
O a, £"1
i H Z ffl
z rD 3
•g *= H
% a\ S o
a, CO 'g 03
w O S H
S o 5 o


Q.

N

0)
4-f
(0
•M
(A

03
i"
O








M
CO
0)
t.
^







i
I
"ra
§
§
<







g
ca
*
CJ
f ..

1
g-
i
u
ON-
§00 .
0
O CM

LL1


O 111
h- U. ;
C9 u-
>-> Hi
_J LJ
S S
—1 '

5E .
CO
UI
S
M
*J
o.
—1
£ CO
>- in
UJ ^ '
o: x
«E 0
en m
'






>
Q , .
in
o
«t
£
m
t—
~ ,
CJ
Q
CO • ' -
i •
UJ
IU
1- 0.
IS '
Q. U
g S
CO
iu- S


'
C\J M • '
in O
M »-
O O

-------
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.

      b.

     ' c.


      d.


      e.


      f.

      g-


      h.


      i.


      j.
 All the blocks on the form must be filled in and answered completely.

 If any block is not applicable, mark it N/A.   -•  .

 The CSF must be signed, dated arid the telephone number of the responsible
 party must be provided.

 All applicable information which is on the product specific data submission
 must also be reported on the CSF.       v

 All weights reported under item 7 must be in pounds per gallon for liquids and
 pounds per cubic feet for solids.

 Flashpoint must be in degrees Fahrenheit and flame extension in inches.

 For all active ingredients, the EPA Registration Numbers for the currently
 registered source products must be reported under column 12.

 The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and
 all common names for the trade names must be reported.

 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.
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 mk 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.
                                       177

-------
178

-------
!

•
i

i
•
\
I
O
i
(
C

;
c
C
T
{
i
^
<
.
£


— ^
«
»
6
u
c
1
0,

<£
^*
•^
C
Q
V
"5
I
i
1

i
g
s
1
 £

c
j
I 1
1 ^
£ i
- i
S J
03 <
na
^



_«
h- *
1 s
ill

i°. 1
;|l«
mnea auni tnvd
OHice of Poiti
Wtihh
idential Si
g
o
O



£
111
£jm
%"
















o

^
i
s
i •
a
'i
L
0
8
0
f
2 .•'
5
D
5
rs







i.



•




,






s
3
3
£
to
>
1
<5
CO



^
e
1
s
«j
•n
£
U
1O


1
s .
s '
E-
1

=
1
•
5
o>

E
X
c
o!
•s

•
-














rt
8
*~

o»
I
2
2
^
























•*
s
1
: .
1

5
I
I
s:
*
3
—
ll


0>
(Q
Q

?i
§
£
1

^
S
6
1
I




















e
= •








5
|
}
:
I
[
3
3
>
c
^.
s
(
%
J.
£


^
c:
&
0,
>.
f
^2
iL

Q.
Ul
§'


f
1
i
c
CO
i!
&
0)
I
JJ-
£ '
1
s
f-
1
ST
gj
1
o
i
I
Previous edltla


1
*•
g
K
r
s
E
0
IL
i 2

179

-------
180

-------
                       United States Environmental Protection Agency
                                   Washington, D.C. 20460
                               Certification of Offer to Cost
                           Share in the Development of Data
    form Approved
  OMB No. 2070-0106,
      2070-0057
   Approval Expires
        3-31-99
 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
                                                                                  Company Number
 Product Name
                                                                                 EPA Reg. No.
 I Certify that:


 My company is willing to develop and submit the data required by EPA under Jhe 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
                                                         i     '
 My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
 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 firms on the following
 Qdt6(SJ!  '                                            .                           '              •
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
Name and Title (Please Type or Print)
Date
                         arm 8580 which is obselete
                                                181

-------
                         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
3-31-99
  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)
                                                         182

-------
?
s
I
j
c
•!
UJ
1
i
i
<

c
<
5
t
c
C
!
i
c
£


-•^
u
(C
2!
c
e

|
•^
Q
V.
I
f
i
§
s
«w
O
|
Q
1
I
|
|
3
Q
§
5
1
i
J




' «0
CO
C
o
M
C
'X
3
a
&





~



i
<6 £


c
^c
si
i E
a o
If
0 *
S 2
CO «)
an
<•

• a
i i

is!

HI
|!l
SSlS
1 *
5 o
T3
**•
o
O


^^
%^
CL
UJ
^«%
^ffv
^
















\
a>
|
i.
e
U H
f
L
5
1
3
3
5
D
5
>i






i
^
•
,

.











•^
2
a
3
o
u.
o
o
>•
t
c
CJ
(O


«i
I
h-
•N
2
« .
1
a.
UJ
u>



I
»
L
6
Z .
Rogitlraliol
v

C
0
'w
UJ
£
<0
1
£
*n -
(0
U.
0>







X
a
CO



£•
1
JC
3
0
3
"~
PoufWJg/Gfl
S

























5l

«
jj
5^:
2

.
c :
So"0
o3
"I1
uj el

^
2
o
K
UJ
ci




IO
1
a
i
O)


LI
1 C
i £
k Z
! w
is
1 « ,
•jaftunu t
KHUUI03 t
nraww
jgs
'i*
]|
O e
•si

g
o

<
0.
UJ




































































































































































,






' '





















1


























































































1































1












































































••




















ae
§
*"
S

~s
-•




































s
 CO
1
IL
I <
to-


-------
       The following is a list of available documents for TERBACIL that my further assist you
in responding to this Reregistration 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 Reregistration Information System at 703-308-7224. They also are available
             on the Internet using WWW (World Wide Web) on WWW.EPA.GOV., or contact
             Karen Jones at (703)-308-8047.
       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 TERBACIL.


      The following documents are part of the Administrative Record for TERBACIL 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
                                         184

-------