United States       Prevention, Pesticides    EPA738-R-98-004
      Environmental Protection   And Toxic Substances    March 1998
      Agency	(7508W)	


ERA Reregistration



      Eligibility Decision (RED)




      Bacillus thuringiensis

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                 United States
                 Environmental Protection
                 Agency	
                        Prevention, Pesticides
                        And Toxic Substances
                        (7511W)	
EPA-738-F-98-001
March 1998
                  R.E.D.    FACTS
     Pesticide
Reregistration
   Use Profile
 * Bacillus   thuringiensis *
     All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances hi 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 reregistxation, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
     When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This feet sheet summarizes the information in the RED document for
reregistration case 0247, Bacillus thuringiensis.

   '  Bacillus thuringiensis is a group of similar bacteria that act as
insecticides which are used on growing agricultural crops, harvested crops in
storage, ornamentals, bodies of water, and around the home to control
various groups of insects, depending on the particular toxins, known as
delta-endotoxins, produced by the specific isolate of Bacillus thuringiensis.
                      Formulations include Water Dispersible Granule, Dry Flowable,
                  Aqueous Suspension, Granule, Technical Powder, Dust, Wettable Powder,
                  Emulsifiable Suspension, Aqueous Flowable, Bait, and Oil Flowable.

                      Bacillus thuringiensis is applied by hand sprayer, water treatment by
                  aerial or ground equipment, soil application by drip or overhead irrigation
                  systems, foliar application by aerial; conventional ground or  hand-held
                  equipment and center-pivot irrigation systems, and sprayer or sprinkler cans.
                      Use practice limitations include Restricted Entry Intervals (REIs) of 4-
                  48 hours for agricultural uses; direct water application is not to be applied

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                    directly to treated, finished drinking water reservoirs or drinking water
                    receptacles; certain terrestrial uses are limited to terrestrial use only due to
                    potential aquatic hazard.
    Regulatory        Bacillus thuringiensis was first registered as a pesticide in the U.S. in
         History   1961.  EPA issued a Registration Standard for Bacillus thuringiensis in
                    December, 1988 (#540/RS-89-023). An associated Data Call-in (DCI)
                    required additional product analysis, toxicology, and nontarget organism
                    data.

                         Currently, approximately 180 Bacillus thuringiensis products are
                    registered under 15 EPA product code numbers. Two of the product codes
                    no longer have active products.

                         Isolates of Bacillus thuringiensis were originally grouped as
                    registrations under the following subspecies names, each with an EPA
                    product code number: Bacillus thuringiensis subspecies  kurstaki, Bacillus
                    thuringiensis subspecies israelensis, Bacillus thuringiensis subspecies
                    aizawai and Bacillus thuringiensis subspecies tenebrionis,  Each isolate is
                    now assigned its own product code number and, as part  of the reregistration
                    process, the original registrations will be given new product numbers.
Human  Health
  Assessment
Toxicity/Pathogenicity
       To date, no known mammalian health effects have been demonstrated
in any infectivity/pathogenicity study. Some strains of Bacillus thuringiensis
 have the potential to produce various toxins that may exhibit toxic
symptoms in mammals, however the manuiacturing process includes
monitoring to prevent these toxins from appearing in products.
                    Dietary Exposure
                         An exemption from the requirements for a tolerance is currently
                    established for Bacillus thuringiensis in or on beeswax and honey and all
                    other raw agricultural commodities when it is applied either to growing
                    crops, or when it is applied after harvest in accordance with good
                    agricultural practices (40 CFR §180.1011).  In addition, there is a tolerance
                    exemption (40 CFR 180.1001(c)) tor Bacillus thuringiensis fermentations
                    solids and/or solubles.  The absence of any toxicological/pathogenicity
                    concerns for oral mammalian exposures to Bacillus thuringiensis warrants
                    continuation of these exemptions as long as the proper quality control
                    procedures are performed.

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                           The specific language in the tolerance .exemption does not reflect
                      current  taxonomy designations for Bacillus thuringiensis isolates. In
                      addition, it includes production testing requirements which will now be
                      required under the product analysis data requirements in 40 CFR 158.740(a)
                      and will apply to all registered isolates and all uses of Bacillus thuringiensis.
                      To ensure that the production batch tests requirements do not lapse for any
                      products, the Agency will repropose the tolerance exemptions  following
                      establishment of the new manufacturing process requirements  as described in
                      the Reregistration Eligibility Document.
  Environmental
    Assessment
    s Toxicity and infectivity risks due to delta-endotoxin effects to
nontarget avian, freshwater fish, freshwater aquatic invertebrates, estuarine
and marine animals, arthropod predators/parasites, honey bees,  annelids and
mammalian wildlife will be minimal to nonexistent at the label use rates of
registered B. thuringiensis active ingredients. However, other toxins which
may be produced by Bacillus thuringiensis can produce adverse  direct toxic
effects on nontarget species. Despite the potential for immediate toxic
effects on target, and possibly some nontarget, organisms, there is no
evidence that Bacillus thuringiensis  can cause epizooatics in the field.
therefore, the Agency has concluded that there will be no potential for
adverse effects on nontarget organisms for B. thuringiensis-based products if
the the presence of soluble, heat labile exotoxins and beta-exotoxin is
minimized.  However, the production process must be^cjosely controlled and
monitored or certified to assure these  exotoxins are not present at levels that
can cause significant adverse ecological effects.
 Risk Mitigation
Additional Data
        Required
      To lessen the potential for the production of various undesirable
Bacillus exotoxins, EPA is requiring the following risk mitigation measures.
o  Production batch testing is required in order to detect undesirable toxins
and to detect contamination by pathogenic bacteria.
o   If the organism is capable of producing beta-exotoxin, the registrant
must ensure that none is present in the TGAI and that the product is not put
in a medium, including formulated end use products that allows germination
and/or growth at any time prior to use.
o Each manufacturing process must be standardized and certified by a
Daphnia magna test using a 10 day exposure period.

      EPA is requiring the submission of a new manufacturing process as an
additional generic study for Bacillus thuringiensis to confirm its regulatory
assessments and conclusions.
      The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, a storage stability study, efficacy

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                         studies for public health uses,  revised Confidential Statements of Formula
                         (CSFs), and revised labeling for reregistration.

  Product Labeling        All Bacillus thuringiensis end-use products must comply with ERVs
Changes Required   current pesticide product labeling requirements and with the following. For
                         a comprehensive list of labeling requirements, please see the Bacillus
                         thuringiensis RED document.

                         Percent Active Ingredient: The percent active ingredient by weight for
                         Bacillus thuringiensis-based products is required in lieu of potency
                         determinations and a statement must be included "There is no direct
                         relationship between intended activity (potency) and the Percent Active
                         Ingredient by Weight."

                         Active Ingredients:  The label must identify the active ingredient as Bacillus
                         thuringiensis and all toxins and/or chemical substances that are present at
                         levels that are known to contribute to the efficacy of the product against the
                         target pest(s) must be listed on the label.                             °
                        Personal Protective Equipment Requirements:  A respiratory protection
                        statement must appear on the label for different uses as follows:
                         Agricultural Use'Products - The personal protective equipment (PPE)
                        section must include the statement: "As a general precaution when exposed
                        to potentially high concentrations of living microbial products such as this,
                        all mixer/loaders and applicators must wear a dust/mist filtering respirator
                        meeting NIOSH standards of at least N-95, R-95, or P-95."
                        Registrants may add the following engineering control statements to the PPE
                        section if they so choose:  "When handlers use closed systems, enclosed
                        cabs, or aircraft in a manner that meets the requirements listed hi 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."
                        PPE for early entry hi the Agricultural Use Requirements box remains
                        unaffected.
                         Non-Agricultural Use Products not Used Around the Home - Either the
                        PPE section or the precautionary statements of the Hazards to Humans and
                        Domestic Animals section must include the statement: "As a general
                        precaution when exposed to potentially high concentrations of living

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                microbial products such as this, all mixer/loaders and applicators not in
                enclosed cabs or aircraft must wear a dust/mist filtering respirator meeting
                NIOSH standards of at least N-95, R-95, or P-95."
                Domestic (Home) Use Products - Either the PPE section or the
                precautionary statements of the Hazards to Humans and Domestic Animals
               - section must include the statement:  "As a general precaution when exposed
                to potentially high concentrations of living microbial products such as this,
                wear a dust particle mask when mixing or applying this product."

                Environmental Hazard Statement:   All commercially applied products-with
                directions for outdoor terrestrial uses must have the following statements hi
                the Environmental Hazards section: "Do not apply directly to water, or to
                areas where surface water is present or to intertidal areas below the mean
                high water mark. Do not contaminate water when cleaning equipment or
                disposing of equipment washwaters." This statement should be preceded by
                "For terrestrial uses," if the product has aquatic sites in addition to
                terrestrial,  forestry (except aerial application) and/or domestic outdoor uses.
                This revised statement would then not apply to other general use patterns —
                aquatic (e.g., mosquito larvicides or adulticides, aquatic herbicides,
                piscicides,  slimicides, etc.),  greenhouse and indoor uses. The "For
                terrestrial uses," qualifier is not allowed on products which allow aerial
                application to forests but which have no approved aquatic use sites.
                     For residential consumer products, the required statement is:  "Do not
                apply directly to water.  Do not contaminate water when disposing of
                equipment  washwaters or rinsate."
                     For direct water application uses, the required statement is:  "Do not
                apply directly to treated, finished drinking water reservoirs or drinking
                water receptacles."

                Spray Drift Labeling:  The following language must be placed  on each
                product label "that can be applied aerially:  "Avoiding spray drift at the
                application site is the responsibility of the applicator. The interaction of
                many equipment-and-weather-related factors determine the potential for
                spray drift. The applicator and the grower are responsible for  considering
                all these factors when making decisions."

Regulatory        The use of currently registered products containing Bacillus
Conclusion   thuringiensis in accordance with approved labeling will not pose

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                unreasonable risks or adverse effects to humans or the environment.
                Therefore, all uses of these products are eligible for reregistration.
                      Bacillus thuringiensis  products will be reregistered once the required
                confirmatory generic data, product-specific data, revised Confidential
                Statements of Formula, and revised labeling are received and accepted by
                EPA.

   For More        EPA is requesting' public comments on the Reregistration Eligibility
Information  Decision (RED) document for Bacillus thuringiensis during a 60-day time
                period, as announced in a Notice of Availability published in the Federal
                Register. To obtain a copy of the RED document or to submit  written
                comments, please contact the Pesticide Docket, Public Response and
                Program Resources Branch, Field Operations Division (7506C), Office  of
                Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
                703-305-5805.
                      Electronic copies of the RED and this feet sheet can be downloaded
                from the Pesticide  Special Review and Reregistration Information System at
                703-308-7224. They also are available on the Internet on EPA's web site at
                www.epa.gov .
                      Printed copies  of the RED and feet sheet can be obtained from EPA's
                National Center for Environmental Publications and Information
                (EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone 513-
                489-8190, fex 513-489-8695.
                      Following the comment period, the Bacillus thuringiensis 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 Bacillus thuringiensis RED, or reregistration of individual products
                containing Bacillus thuringiensis, please contact the Biopesticides and
                Pollution Prevention  Division (7511W), OPP, US EPA, Washington, DC
                ' 20460, telephone 703-308-8712.
                      For information about the health effects of pesticides, or for assistance
                hi recognizing and managing pesticide poisoning symptoms, please contact
                the National Pesticides  Telecommunications Network (NPTN). Call toll:
                free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard Tune,
                Monday through Friday.

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

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

2. TIME EXTENSIONS AND DATA WAIVER  REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only  with
respect to actual data submissions.  Requests for tune  extensions for product specific data
should be submitted hi 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"-You must
submit the following items for each product within  eight months of the date of this letter
(RED issuance date).

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

      b.  Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes,  or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible  for reregistration,. For further
labeling guidance, refer to the labeling section of the EPA publication "General Information on
Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
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, if available for that study.

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      d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40  CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along  with a certification statement as described in 40 CFR §158.175(e).  A copy of
the CSF is enclosed; follow the instructions on its back.

      e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.

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

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

Bv U.S. Mail;

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

By express:

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

6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will  be returned with a request for corrections. EPA will try to respond to data
waiver and tune extension requests within 60 days. EPA will also try to respond to all  8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.

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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                     WASHINGTON, D.C. 20460
                                                                          OFFICE OF
                                                                     PREVENTION, PESTICIDES
                                                                     AND TOXIC SUBSTANCES
                                                                           3 !  J998
CERTIFIED MAIL
Dear Registrant:
                                                                                 t
       I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case 0247, which
includes the active ingredient Bacillus thuringiensis. The enclosed Reregistration Eligibility
Decision (RED) contains the Agency's evaluation of the data base of this microbial pest control
agent, its conclusions of the potential human health and environmental risks of the current
product uses, and its decisions and conditions under which these uses and products will be
eligible for reregistration.  The RED includes the data and labeling requirements for products
for reregistration.  It also includes requirements for additional data (generic) on the  active
ingredient to confirm the risk assessments.

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

       Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both the pesticide law (FIFRA) and the food  and drug
law (FFDCA).  This RED takes into account the  new safety standard set by the FQPA for
establishing and reassessing tolerances.  However, it should also be noted that in continuing to
make the reregistration determinations during the early stages- of FQPA implementation, EPA
recognizes that it will be necessary to make decisions relating to FQPA before the

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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 the 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 generic and product specific data requirements or wish to
meet with the Agency, please contact the Biopesticides and Pollution Prevention Division
representative, William R. Schneider, at (703) 308-8683, or send eMail to Schneider.william
@epamail.epa.gov

                                                     Sincerely yours,
                                                      anet L. Andersen, Ph. D., Director
                                                     Biopesticides and Pollution
                                                       Prevention Division
Enclosures

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REREGISTRATION ELIGIBILITY DECISION

            Microbial Pesticides:
           Bacillus thuringiensis


                 LISTD

               CASE 0247

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                          TABLE OF CONTENTS

BACILLUS THURMGDENSIS REREGISTRATION ELIGIBILITY DECISION TEAM
        	,	i

EXECUTIVE SUMMARY  	'. . . 1

I.     INTRODUCTION	2

H.    CASE OVERVIEW  	3
      A.    Chemical Overview	3
      B.    Use Profile	4
      C.    Estimated Usage of Pesticide  	~. .'.	6
      D.    Data Requirements	6
      E.    Regulatory History	7

IH.   SCIENCE ASSESSMENT	8
      A.    Product Analysis Assessment	8
            1.    Identification of Active Ingredients  	8
                  a.    Product Identity  	8
                  b.    Manufacturing Process	10
                  c.    Discussion of Formation of Unintentional Ingredients .... 11
      B.    Human Health Assessment	11
            1.    Toxicology Assessment	11
                  a.    Acute toxicity/pathogenicity  	11
                  b.    Potential for producing Bacillus cereus enterotoxins  ..... 12
                  c.    Effects on the Immune and Endocrine Systems	 . 13
            2.    Dietary Exposure and Risk Characterization	14
            3.    Occupational, Residential, School and Daycare Exposure and Risk
                  Characterization	14
                  a.    Occupational Exposure and Risk Characterization	14
                  b.    Residential,   School  and   Daycare   Exposure  and  Risk
                        Characterization	,	14
            4.    Drinking Water Exposure and Risk Characterization	14
            5.    Acute  and Chronic  Dietary  Risks  for  Sensitive Subpopulations
                  Particularly Infants and Children	15
            6.    Aggregate Exposure from Multiple Routes Including Oral, Dermal and
                  Inhalation	15
      C.    Environmental Assessment	 15
            1.    Ecological Toxicity Data  	15
                  a.    Toxicity to Terrestrial Animals	16
                  b.    Toxicity to Aquatic Animals	22

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                  c.    Toxicity to Plants  	25
            2.    Exotoxin Effects	25
            3.    Environmental Fate	26
            4.    Exposure and Risk Characterization	26
      D.    Product Performance (Efficacy) Assessment	31

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	32
      A.    Determination of Eligibility	32
            1.    Eligibility Decision  	32
            2.    Eligible and Ineligible Uses   	33
      B.    Regulatory Position	33
            1.    Tolerance Reassessment (40 CFR 180.1011 and 40 CFR 180.1001(c))
                   	33
            2.    Risk Mitigation	34
                  a.    Mitigation Measures for Dietary, Occupational and Residential
                        Risk	34
                  b.    Mitigation  Measures  for  Nontarget  Organisms  (Plants  and
                        Wildlife), or Ground and Surface Water Contamination
                         	.'.'	 .  ;	34
            3.    Endangered Species Statement 	35
            4.    Labeling Rationale  	,	35
            5.    Spray Drift Advisory	36
            6.    Product Performance (Efficacy) Reassessment	36

V.    ACTIONS REQUIRED OF REGISTRANTS	37
      A.    Manufacturing-Use Products  	37
            1.    Additional Generic Data Requirements  	38
                  a.    Qualitity Control Manufacturing Process Data Requirements
                   	 . .	38
                  b.    Standarization of Manufacturing Process	39
            2.    Labeling Requirements for Manufacturing-Use Products	39
      B.    End-Use Products	.42
            1.    Additional Product-Specific Data Requirements  	42
            2.    Labeling Requirements for End-Use Products	43
      C.    Existing Stocks	50

VI. APPENDICES	51
      APPENDIX A. Use Sites for the Reregistration of 0247	53
      APPENDIX B   Table of the  Generic Data Requirements and Studies Contributing
     ' to the Reregistration Decision	58
      APPENDIX C   Data Cited as Part of the Data Base Supporting the Reregistration
      of Bacillus thuringiensis  	61
      APPENDIX D   Combined Generic and Product Specific Data Call-In   	93

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BACILLUS THURINGIENSIS REREGISTRATION ELIGIBILITY DECISION TEAM

Office of Pesticide Programs:

Use Profile

Arthur H. Grube                        Biological & Economic Analysis Division
Sandra M. Zavolta                      Biological & Economic Analysis Division

Environmental Fate and Effects Risk Assessment

Zigfridas Vaituzis, Ph.D.                 Biopesticides & Pollution Prevention Division

Health Effects Risk Assessment

John L. Kough       .                   Biopesticides & Pollution Prevention Division
Cindy R. Schaffer                       Biopesticides & Pollution Prevention Division

Registration Support

Michael L. Mendelsohn   .               Biopesticides & Pollution Prevention Division

Reregistration Support       (

Richard W. King                        Biopesticides & Pollution Prevention Division
Shanaz Bacchus                         Biopesticides & Pollution Prevention Division

Former BPPD Scientists who contributed to preliminary reviews.

Clayton C. Beegle, Ph.D.
Mark J. Perry
Robert I. Rose, Ph.D.
                                  '(                               i
Registration Eligibility Document.- team leader

William R. Schneider, Ph.D.             Biopesticides & Pollution Prevention Division

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GLOSSARY OF TERMS  AND ABBREVIATIONS
ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
ORES
DWEL
EEC

EP
EPA
FAO/WHO
FDA
FIFRA
FFDCA
FQPA
FOB
GLC
GM
GRAS
HA

HOT
LCSO
LD
   SO
LD,0
LEL
LOG
LOD
LOEL
MATC
MCLG

jig/g
mg/L
MOE
MP
       'Acceptable Daily Intake. A now defunct terin for reference dose (RfD).
        Acid Equivalent
        Active Ingredient
        Anticipated Residue Contribution
        Chemical Abstracts Service
        Cation
        Central Nervous System
        Confidential Statement of Formula
        Dislodgeable Foliar Residue
        Dietary Risk Evaluation System                                  '
        Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
        water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
        occur.
        Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
        such as a terrestrial ecosystem.
        End-Use Product
        U.S. Environmental Proteclion Agency
        Food and Agriculture Organization/World Health Organization
        Food and Drug Administration
        Federal Insecticide, Fungicide, and Rodenticide Act
        Federal Food, Drug, and Cosmetic Act
        Food Quality Protection Act
        Functional  Observation Battery
        Gas Liquid Chromatography
        Geometric Mean
        Generally Recognized as Safe as Designated by FDA
        Health Advisory (HA).  The HA values are used as informal guidance to municipalities and other
        organizations when emergency spills or contamination situations occur.
        Highest Dose Tested
        Median Lethal Concentration.  A statistically derived concentration of a substance that can be
        expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
        per weight  or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
        Median Lethal Dose.  A statistically derived single dose that can be expected to cause death in 50 %
        of the test  animals when administered by the route indicated (oral, dermal, inhalation) .  It is
        expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
        Lethal Dose-low. Lowest Dose at which lethality occurs.
        Lowest Effect Level
        Level of Concern
        Limit of Detection
        Lowest Observed Effect Level
        Maximum Acceptable Toxicant Concentration
        Maximum  Contaminant Level Goal (MCLG)  The MCLG is used by the Agency  to  regulate
        contaminants in drinking water under the Safe Drinking Water Act.
        Micrograms Per Gram
        Micrograms per liter
        Milligrams Per Liter
        Margin of Exposure ,
        Manufacturing-Use Product
                                         111

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MPCA         Microbial Pest Control Agent
MPl            Maximum Permissible Intake
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",             The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC            Red Blood Cell
RED            Reregistration Eligibility Decision
REI            Restricted Entry Interval
RfD            Reference Dose
RS              Registration Standard
RUP            Restricted Use Pesticide
SLN            Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC             Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD             Toxic Dose. The dose at which a substance produces a toxic effect.
TEP            Typical End-Use Product
TGAI           Technical Grade Active Ingredient
TLC            Thin Layer Chromatography
TMRC          Theoretical Maximum Residue Contribution
torr             A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP             Wettable Powder
WPS            Worker Protection Standard
                                                 IV

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EXECUTIVE SUMMARY

       The U. S. Environmental Protection Agency has completed its reregistration eligibility
decision of the group of rnicrobial pesticides registered as Bacillus thuringiensis. This decision
includes a comprehensive reassessment of the required target data and the use patterns of currently
registered products. Bacillus thuringiensis is a group of similar bacteria that act as insecticides
which are used on growing agricultural crops, harvested crops hi storage, ornamentals, bodies of
water, and around  the home to control various groups of insects, depending on the particular
toxins produced by the specific isolate of Bacillus thuringiensis.  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  uses are eligible for reregistration. In addition to the toxins that
are active against the insect pests, Bacillus thuringiensis may produce undesirable toxins. To
mitigate risks of potential toxicity to the public and/or non target species from these toxins, the
Agency is  requiring continuation of the production batch quality control testing that originally
appeared in the  tolerance exemption and is requiring the revaluation and standarization of the
manufacturing process for each registered  technical grade of the  active ingredient.  In addition,
several label changes are required for all Bacillus thuringiensis rnicrobial products.  The method
for determining percent active ingredient has  been standardized.  The revised percent active
ingredient, a statement of explanation,  and the specific toxins responsible for the pesticidal
activity must now be included on the labels of all Bacillus thuringiensis products.

       Before reregistering the microbial pesticide products containing Bacillus thuringiensis, the
Agency is requiring certain product specific data (product analysis and acute toxicity), a revised
Confidential Statement of Formula (CSF) and revised product labeling be submitted within  eight
months of the issuance of this document. After reviewing these data and 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.

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I.     INTRODUCTION

       In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. 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.

       FIFRA Section 4(g)(2)(A) states that in Phase 5  "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling in data
on products and either reregistering products or taking "other appropriate regulatory  action."
Thus, reregistration involves a thorough review of the  scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards  arising from
the currently registered uses  of the pesticide; to determine the need for additional data on health
and environmental effects; and to determine whether the pesticide meets the "no unreasonable
adverse effects" criterion of FIFRA.

       This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of the microbial pesticide,  Bacillus thuringiensis. The document consists of six
sections. Section I is the introduction. Section n describes Bacillus thuringiensis, 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 Bacillus thuringiensis. Section V discusses the reregistration requirements for Bacillus
thuringiensis. Finally,  Section VI is the Appendices which support this Reregistration Eligibility
Decision. Additional details concerning the Agency's review of applicable data are  available on
request.

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II.     CASE OVERVIEW

       A.    Chemical Overview
                                                      \
             This Reregistration Eligibility Decision covers the group of bacterial products
       (considered as pesticidal active ingredients) classified as Bacillus thuringiensis. Bacillus
     .  is a genus of rod-shaped bacteria that produce not more than one endospore per cell and
       the sporulation is not repressed by exposure to air, have a gram-positive cell wall, and are
       aerobic or facultatively anaerobic.  The species thuringiensis, in the genus Bacillus, is
       distinguished by the production of one or more protein parasporal crystals in parallel with
       spore formation. The parasporal protein crystals are delta endotoxins that are generally
       toxic to a variety of insects. Some isolates of Bacillus thuringiensis produce other toxins
       that, in some cases, may contribute to the insecticidal activity.

             The regulatory decisions described in this Reregistration Eligibility  Decision
       document,  particularly those  involving labeling changes, tolerance reassessment,  and
       manufacturing processes, will apply to all microbial products  registered as a Bacillus
       thuringiensis. When additional generic and/or product specific data are needed to support
       1984 and earlier registrations, the data will be described in the data call-in attached to this
       document. Data will be called in, when required, for post-1984 registrations by means of
       notifications sent directly to registrants.
       •      Common Names and OPP Chemical Codes*:
                                                                      i
       Microbial Pesticide Name:  Bacillus thuringiensis (all subspecies)
       OPP Chemical Code: 006400
       Microbial Pesticide Name:  Bacillus thunngiensis subspecies israelensis
       OPP Chemical Code: 006401
       Microbial Pesticide Name:  Bacillus thuringiensis subspecies kurstaki
       OPP Chemical Code: 006402
       Microbial Pesticide Name:  Bacillus thuringiensis subspecies aizawai
       OPP Chemical Code: 006403
       Microbial Pesticide Name:  Bacillus thuringiensis subspecies tenebrionis
       OPP Chemical Code: 006405
       Microbial Pesticide Name:  Bacillus thuringiensis subspecies kurstaki BMP123
       OPP Chemical Code: 006407
       Microbial Pesticide Name:  Bacillus thuringiensis subspecies kurstaki EG2424 '
       OPP Chemical Code: 006422
       Microbial Pesticide Name:  Bacillus thuringiensis subspecies kurstaki EG2371
       OPP Chemical Code: 006423
       Microbial Pesticide Name:  Bacillus thuringiensis subspecies kurstaki EG2348
       OPP Chemical Code: 006424

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Microbial Pesticide Name: Bacillus thuringiensis subspecies aizawai GC-91
OPP Chemical Code: 006426
Microbial Pesticide Name: Bacillus thuringiensis subspecies kurstaki EG7673
OPP Chemical Code: 006448
Microbial Pesticide Name: Bacillus thuringiensis subspecies kurstaki M200
OPP Chemical Code: 006452
Microbial Pesticide Name: Bacillus thuringiensis subspecies kurstaki EG7841
OPP Chemical Code: 006453
Microbial Pesticide Name: Bacillus thuringiensis subspecies kurstaki EG7826
OPP Chemical Code: 006459

*      In the internal file numbering system, EPA has grouped several of the earlier
Bacillus thuringiensis registrations under the same OPP Chemical Codes.  The Bacillus
thuringiensis registrations issued after the Registration Standard was published have all
been assigned  separate OPP Chemical Codes.  To maintain consistency, The  Agency
intends to assign new Chemical Code numbers to each active ingredient that was formerly
assigned to a previously-used chemical code. This internal renumbering will not affect any
opportunity to share data from one registration to another if scientifically justified.

•      Trade Names:

Vectobac, Dipel, BiobitWP, BiobitFC, SkeetalFC, Foray, Futura, Javelin, Bactospeine,
Bactimos, M-one, Thuricide-HPC, Larvo-BT, Trident, Ditera, Novodor, Xentari, BMP
123, Condor, Cutlass, Foil, Agree, Raven, Able, Crymax

•      Basic Manufacturers:
Abbott Laboratories                        Novartis Crop Protection
Chemical & Agricultural Products Div        PO Box 18300
1401 Sheridan Rd                          Greensboro, NC 27419-8300
D-28R, Bldg Al                           (Note: All Novartis Bt products have
North Chicago, IL 60064                   recently been transferred.)

Becker Microbial Products, Inc.              Thermo Trilogy
9464 NW llth St                          7500 Grace Drive
Plantation, FL 33222                       Columbia, MD 21044-4098

Ecogen, Inc.                               Troy Corporation
2005 Cabot Blvd West                      8 Vreeland Rd
Langhorne, PA 19047                      Florham Park, NJ 07932-0955

B.     Use Profile

       The following is information on the currently registered uses with an overview of

                                   4

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use sites and application methods.  A detailed table summarizing the use by site for
Bacillus thuringiensis is in Appendix A.

       Type of pesticide: Insecticide (microbial pest control agent)

       Use sites: Terrestrial food and non-food crops, aquatic food and non-food crops,
       greenhouse food and non-food crops, forestry, domestic outdoor,  indoor stored
       product use. Based on available pesticide survey usage information for the years
       of 1987 through 1996, an average of about 1.4 million base acres of traditional
       agricultural crops are likely treated with Bacillus thuringiensis (B.t.) annually. A
       reasonable upper bound for possible acres treated would be about 2.1 million acres.
       An additional 30,000 (50,000 likely maximum) acres  of nursery and greenhouse
       plants and cut flowers and greens are treated annually.  B.t. is also applied for
       mosquito and black fly control on an average of approximately 1 million acres (1.5
       million likely maximum) and for use in forests and parks, mostly for gypsy moth
       control.  The forest and park average use is 750,000 acres  (1.5  million likely
       maximum).  Base acres  are those treated at least once.  Some crop acreage is
       treated more than once annually.

       Agricultural sites with a large number of base  acres treated are  corn, cotton,
       grapevines and leafy vegetables.  Crops with a high percent of the total U.S. crop
       treated include artichokes (90+ %), blackberries (50%), raspberries  (30%), celery
       (46%), spinach (40%), and cabbage (39%).  The remaining usage is primarily on
       fruits and vegetables.  Areas with the largest usage  are California, the Pacific
       Northwest (Oregon and Washington), and Florida.

       Target Pests:  Lepidoptera, coleopteran and dipteran insects

       Formulation Types Registered:  Water Dispersible  Granule, Dry  Flowable,
       Aqueous  Suspension, Granule, Technical  Powder,  Dust, Wettable Powder,
       Emulsifiable Suspension, Aqueous Flowable, Bait, Oil Flowable.

       Methods  of Application: Hand  sprayer; water treatment by  aerial  or ground
       equipment;  soil  application by  drip  or  overhead  irrigation  systems;  foliar
       application by aerial,  conventional ground or   hand-held  equipment  and
       center-pivot irrigation systems; sprayer or  sprinkler cans.

       Use Practice Limitations: Restricted Entry Intervals (REIs) of 4- 48 hours for
       agricultural uses; direct water application is not to be applied directly to treated,
       finished drinking water reservoirs or drinking water receptacles; certain terrestrial
       uses are limited to terrestrial use only due to potential aquatic hazard.

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C.     Estimated Usage of Pesticide

       The table in Appendix A summarizes the best estimates available for the pesticide
uses at Bacillus thuringiensis. 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 hi use patterns as well as the variability hi using
data from various  information sources.

D.     Data Requirements

       The December, 1988, Registration Standard for Bacillus thuringiensis required
submission of studies on characterization data.  These  data were required to enable EPA
to reclassify registered strains into groups of strains with similar characteristics.  In
addition,  data  was requested which included studies on product analysis, nontarget
organisms, environmental fate, and residue analysis to  support the  uses  listed  hi the
Registration Standard. This  additional data was not required to be submitted within the
time frames indicated hi the  Registration Standard if the  company wished to share data
between different strains or wished to utilize data already submitted to the Agency.  In this
case, the timeframe for submissions would begin once the Agency has determined whether
sharing of data is warranted or whether  testing performed prior to the  Registration
Standard was done on strains sufficiently similar to strains currently in registered pesticide
products.  Based on information from the scientific literature published subsequent to the
Registration  Standard, the Agency believes that decisions on data sharing and strain
similarity should be based on the similarity of delta endotoxins and other toxic/synergistic
components contributing  to  the pesticidal activity  of the  particular  strain of Bacillus
thuringiensis.  Furthermore, the Agency now has sufficient information  to simplify the
registration requirements for isolates of Bacillus thuringiensis. As a result, many of the
toxicity/pathogenicity and ecological effects tests are eligible for data waivers.

        The submitted data plus data from the literature, which was not available at the
time of the data call-in for the registered products,  has shown the Agency that testing a
laboratory-grown culture of  the active ingredient as specified by 40 CFR 158.740 is not
reliable to detect  the presence of certain undesirable toxins that may be produced by
Bacillus thuringiensis because their synthesis appears to depend on unpredictable aspects
of the fermentation process.  Thus, one reliable method to detect these undesirable toxins
is to test each production batch. Production batch testing to detect some of the undesirable
toxins, as  well as to detect contamination by pathogenic bacteria, has been required under
the tolerance exemption,  40 CFR  180.1011, and was extended to all products  in the
Registration Standard, of  December, 1988.  Since 1988, the Agency has identified a new
concern for the heat labile exotoxins that are toxic to Daphnia, but the Agency has no
information on whether the current battery of production batch tests will detect these.  The
Agency does believe  that the presence of heat labile  exotoxins should be minimized in
products (see section IV(B)(2)(b)). In lieu of requiring a Daphnia test on each production

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batch, this Registration Eligibility Document specifies that registrants optimize and control
their manufacturing process sufficiently to prevent production of significant amounts of
these heat labile exotoxins. Accordingly, each new manufacturing process must be tested
by a Daphnia study as an indicator of the heat labile exotoxin levels produced under those
conditions. This will assure that heat labile exotoxin levels will not exceed the levels used
by the Agency in its risk assessment. Appendix B summarizes these data requirements.
E.     Regulatory History

       An isolate at Bacillus thuringiensis was first registered in the United States in 1961
for use as an insecticide. At that time, the 7th edition of Bergey's Manual of Determinative
Bacteriology (1957) did not recognize any  subdivisions of Bacillus thuringiensis. Later,
other isolates of Bacillus thuringiensis were discovered to contain  differently shaped
protein toxin inclusion bodies (delta endotoxins) which affected different insects. Thus,
the 8th edition of Bergey's Manual of Determinative Bacteriology (1974) subclassified
Bacillus  thuringiensis into 11 varieties  based on the serotype of antigens  found on the
flagella,  and the latest edition, Bergey's Manual of Systematic Bacteriology, Vol 2 (1986)
acknowledged  a larger  number of these varieties  but recommended they be called
subspecies.   Thus the isolates of Bacillus thuringiensis registered prior to 1984 were
grouped under the following subspecies names: Bacillus thuringiensis subspecies kurstaki,
Bacillus thuringiensis subspecies israelensis and Bacillus thuringiensis subspecies aizawai.
Others, such as Bacillus thuringiensis subspecies tenebrionis, were registered later.

       The Agency no longer groups new  isolates under the subspecies name because it
is now known that the delta endotoxin genes, which generally reside on transferable
genetic elements (plasmids) can be readily moved from one isolate to another, regardless
to which subspecies they belong.  Therefore, isolates 'registered since 1989 have been
registered as individual active ingredients.  Furthermore, some of the delta endotoxins
from Bacillus  thuringiensis,  when produced  by genetic  sequences  inserted into other
bacteria  or plants,  have  also been  registered separately.  However,  this Reregistration
Eligibility Document includes genetically manipulated delta-endotoxins only when they are
contained in Bacillus thuringiensis  bacteria.  The primary scientific issues addressed by
this document involve the exotoxins that may be produced by Bacillus thuringiensis; issues
which are not at all relevant to other kinds of organisms engineered to contain the delta-
endotoxin genes.

       A Data Call-in  was  issued  in  conjunction with  a  Registration  Standard in
December, 1988, (#540/RS-89"-023) for Bacillus thuringiensis requiring additional data for
Product Analysis, Toxicology, and Nontarget Organisms. This Reregistration Eligibility
Decision is based  on an assessment of data  which were  submitted  in response to the
Registration Standard.

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in.    SCIENCE ASSESSMENT

       A.     Product Analysis Assessment

              1.     Identification of Active Ingredients

                     a.      Product Identity

                     For a new isolate to be classified in the group of bacteria called Bacillus
              thuringiensis it must be a gram positive, aerobic or facultatively anaerobic, rod
              shaped bacterium containing  a crystalline insecticidal protein (delta-endotoxin).
              Historically,  flagellar antigen serotype analysis was used to classify individual
              Bacillus  thuringiensis subspecies.    For example, all Bacillus  thuringiensis
              subspecies aizawai strains have a flagella antigen of serotype H7; the serotype for
              Bacillus  thuringiensis subspecies israelensis  is  H14; Bacillus  thuringiensis
              subspecies kurstaki is 3a3b and Bacillus thuringiensis subspecies tenebrionis  is
              8a8b.  However, genetic engineering  techniques now allow  genetic  material
              encoding the delta-endotoxin insecticidal protein to be moved among subspecies to
              give different host spectrum  ranges.  Thus, the Agency will no longer use the
              subspecies taxonomic unit as  a primary  differential characteristic of the species.
              The Agency will consider each new strain (a pure culture of descendants of a single
              isolation) of  Bacillus thuringiensis  as a new  active ingredient.  However, its
              similarity to currently registered strains/isolates of Bacillus thuringiensis may allow
              the toxicology and ecological effects data for those registered active ingredients to
              support the new registration.  Identification of the  delta-endotoxins produced by
              each strain will  be  useful to users  of these products in pesticide resistance
              management. On request by the registrant, the Agency may allow a certain amount
              of genetic variation, intentional or unintentional, from the recorded characteristics
              of the registered strain if documented well enough to perform an incremental risk
              assessment.   This type of variant might be handled  through  a change  in the
              confidential statement of formula (CSF), and, if the changes involve characteristics
              of delta-endotoxins or other chemical substances that contribute  to the toxicity to
              the target pest, may warrant a modification to the label.

                     The Registration Standard for  Bacillus thuringiensis, published in 1988,
              required nine lands of characterization data in an attempt to provide an identity
              profile for each active ingredient.  The following five, out of the nine,  kinds of
              product identity data subsets  (McClintock, J.T., C.R.  Schaffer, J.L.  Kough, &
              R.D. Sjoblad (1995) Relevant Taxonomic Considerations for Regulation of Bacillus
              thuringiensis-'Based. Pesticides by the U.S. Environmental Protection Agency. In
              T-Y Feng, et al. (eds.),  "Bacilus thuringiensis Biotechnology and Environmental
              Benefits.",  Vol. I, 313-325.) were useful hi distinguishing different  isolates as
              follows.

                                            8

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       (1)    Biochemical and Nutritional Characteristics.

       The biochemical and nutritional characteristics  (as referenced in
Bergey's reference manual) are useful to differentiate Bacillus thuringiensis
from other similar Bacillus species (i.e. B. cereus, B. anthracis);  and can
be useful in differentiating closely related varieties of  subspecies of the
same species.
                                                           \

       (2)    Antibiotic Susceptibility.

       Antibiotic  susceptibility  determinations  also  may be useful hi
characterizing Bacillus thuringiensis strains.  Each Bacillus thuringiensis
strain was evaluated for sensitivity against and up to a total of 33 various
antibiotics.   Very little difference  between these strains  of Bacillus
thuringiensis was  observed, however these tests are inexpensive and are
likely to be useful  in differentiating other strains of Bacillus thuringiensis.
This  information  is  also  useful for isolation  of these  strains  from
environmental or clinical samples.

       (3)    Host Range Spectrum.

       Historically,   Bacillus   thuringiensis  subspecies   have   been
differentiated by their pesticidal activity against species in the following
four insect orders: Lepidoptera, Orthoptera, Diptera and Coleoptera.  For
example,  Bacillus thuringiensis subspecies kurstaki show strong activity
against Lepidopteran  species and limited activity .on  Coleopteran and
Orthopteran species; Bacillus thuringiensis subspecies israelensis strains
exhibit against Dipteran species with limited activity against Lepidopteran
and Coleopteran; Bacillus thuringiensis subspecies aizawai strains display
some  activity  against  Coleopteran  species  but  more  activity  on
Lepidopteran; and Bacillus thuringiensis subspecies tenebrionis is active on
only Coleopteran species.  These generalizations were confirmed for these
particular active ingredients by these characterization data.

       (4)    Beta-exotoxin Activity.

       Bacillus thuringiensis isolates may  also produce a heat stable  beta-
exotoxin  called  thuringiensin.    The  registrants  must  provide  data"
demonstrating the lack of beta-exotoxin activity in the TGAI.  The presence
of beta-exotoxin, thuringiensin, has been  evaluated by  HPLC and/or fly
larvae bioassay. Beta-exotoxin was observed hi one Bacillus thuringiensis
subspecies aizawai strain under laboratory  conditions by demonstrating up

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       to 24%  mortality  in  the  fly  larvae  assay.   This strain may require
       production batches to be discarded if beta-exotoxin is not eliminated during
       production and is detected in the batch quality control testing (see section
       V, Actions Required of Registrants).

              (5)     Intraperitoneal Assays.

              The Intraperitoneal (ip) injection assay of Bacillus thuringiensis hi
       mice  is used  as a quality control measure  to demonstrate the lack of
       mammalian toxicity of the TGAI, but the protocols were not fully validated
       at the time  of the  1988  Registration  Standard.    The Agency  has
       subsequently found that high dose levels of 10s colony forming units (CPU)
       per animal in this assay often show mortality, even for bacteria generally
       regarded as nonpathogenic and nontoxic, such as Bacillus subtilis. Some
       of the submitted ip assays showed this mortality at high doses; however,
       they supported the lack of toxicity at doses  of 107  and below for these
       isolates of Bacillus thuringiensis.

              (6)     Other Product Identity Data.

              The following four kinds of product identity data subsets requested
       in the 1988 Registration Standard did not prove to be sufficiently consistent,
       or  lacked  useful   information  for distinguishing  strains  of  Bacillus
       thuringiensis: (1) History of the strain, (2) Insecticidal toxins produced, (3)
       Plasmid profiles, and (4) Description of crystalline proteins.  These data are
       no  longer required  for registration,  although  identification  of  the
       insecticidal toxins using more recent methods will  be required for prdper
       labeling.

       b.     Manufacturing Process

       The technical grade active ingredient of each Bacillus thuringiensis product
is  generally  manufactured using a standard fermentation  batch process.  The
material  is then  concentrated, and either dried, or mixed with inerts in a liquid
form, and  then  packaged.  Registrants have not been required  to adhere  to a
standardized  fermentation protocol. However, the Agency is concerned about the
potential for the production of various undesirable Bacillus  exotoxins because then-
synthesis appears to depend on unpredictable aspects  of the fermentation process.
Accordingly, through this document the  Agency is implementing measures to
mitigate  these risks. Refer to  Section IV,  Risk Management and Reregistration
Decision, and V, Actions  Required of Registrants.
                              10

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             c.     Discussion of Formation of Unintentional Ingredients

             Generally, fermenter solids  and solubles  may  be present  in  the  final
       product.  An exemption from the requirements of a tolerance has been granted for
       these (40 CFR 180.1001(c)) and has been reassessed in this document (see section
       IV(B)(1)). It is the Agency's opinion that quality control procedures, as described
       in Section V, Actions Required of Registrants, for each product which test for the
       presence of contaminants such as human pathogens, or undesirable toxins in each
       batch will adequately mitigate potential risks to humans.  Any production batch
       containing unwarranted levels of contaminants must be discarded,

B.     Human Health Assessment

       1.    Toxicology Assessment

             a.     Acute toxicity/pathogenicity

             The Agency has an historical toxicology data base for Bacillus thuringiensis
       (See 4/23/86  Memorandum from William Woodrow to Arturo Castillo).   In
       addition, a  summary review of mammalian toxicity studies was published by
       Agency  reviewers (McClintock, J.T., C.R. Schaffer, & R.D. Sjoblad (1995) A
       Comparative Review of the Mammalian Toxicity of Bacillus thuringiensis- Based
       Pesticides. Pestic. Sci. 45, 95-105). To date, no known mammalian health effects
       have been demonstrated in any infectivity/pathogenicity study  (Table  1, Acute
       Mammalian Toxicity for Bacillus thuringiensis'). The sum total of all toxicology
       data submitted to the Agency complete with the lack of any reports of significant
       human health hazards  of the various Bacillus thuringiensis strains allow the
       conclusion that all infectivity/pathogenicity studies normally required under 40
       Code of Federal Regulations,  Part  158, for the use patterns of the registered
       products be waived  in the future as  long as product identity  and manufacturing
       process testing data  indicated there is no mammalian toxicity  associated with the
       strain. In accordance with standard practices when these studies are waived, label
       language will be required assuming a Toxicity Category of IE.
                                    11

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            Table 1: Acute Mammalian Toxicity for Bacillus thuringiensis
Guideline
Numbers*
1S2A-10
(885.3050)
1S2A-12
(885.3200)
N/A
(generally
received under
151A-10,
Product
Analysis)
152A-15
(885.3400)
81-2
(870.1200)
Study
Acute Oral Toxicity/
Pathogenicity
Acute Pulmonary
Toxicity/
Pathogenicity
Acute Intraperitoneal
Toxicity/
Pathogenicity
Hypersensitivity
Incidence Reporting
Acute Dermal
Toxicity
Results
No adverse toxic effects, mfectivity,
or pathogenicity seen at doses up to
4.7x10" spores/kg.
No adverse toxic effects, mfectivity,
or pathogenicity seen at doses up to
2.6xl07 spores/kg.
Non toxic at dose levels below 108
colony forming units (CPU) per
animal. No infectivity or
pathogenicity.
Two possible incidences reported,
neither one was caused by Bacillus
thuringiensis.
No dermal toxicity observed at doses
up to 4.7x10"
Toxicity
Category
IV
IV
N/A
N/A
IV '
MRIDs
142733 96520
41046704 96527
42006502 96533
43186101 109492
40951102 246968
96529
41308603
42006503
66178 41441609
66179 41441611
90207 41441612
90208 41722507
41590302 41826608
41270301 41826609
41308607 41994303
41441504 42750401
41441505 42791301
41441506
420271
142734 419943
109493 41412705
404974
1988 Subdivision M (1995 Harmonized Guidelines)

                   Primary dermal irritation (81-5, 870.2500) and primary eye irritation (81-4,
            870.2400) were not required under the 1988 Registration Standard because these
            studies are not  required for the TGAI (40 CFR 158.740).  These studies are
            required and will be reviewed for the manufacturing-use and the end-use products.
            In general, slight to moderate skin irritation has occasionally been observed in
            product tests, which may be attributed to other ingredients in the formulation, and
            occasionally eye irritation has been seen in primary eye irritation tests.  This is
            often associated with dry, anhydrous forms of the product and may be due to
            physical irritation effects as might be caused by sand or drying agents rather than
            caused by traditional toxicity.

                   b.     Potential for producing Bacillus cereus enterotoxins

                   The Agency is aware of research results that indicate that registered Bacillus
            thuringiensis products  may be able to produce the diarrhoeal enterotoxin usually
                                          12

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associated  with  Bacillus  cereus.    A  comparison of  commercial Bacillus
thuringiensis strains with a clinical  isolate of Bacillus  cereus reported that all
commercial products tested could produce the diarrhoeal enterotoxin, but at very
low levels compared with the clinical isolate (Damgaard, D.H.  (1995), Diarrhoeal
enterotoxin production  by  strains  of  Bacillus  thuringiensis  isolated  from
commercial Bacillus thuringiensis-based insecticides. FEMS Immuno. and Med.
Microbiol. 12, 245-250). However, at this time the Agency has no valid evidence
to link actual usage of Bacillus thuringiensis insecticides with episodes of diarrhoea
following ingestion of food.  Bacillus  cereus, and other  naturally-occurring
toxigenic microorganisms, can normally be found on many  kinds of foods, but
niust  multiply in the foods  in order to produce the toxins  responsible for the
symptoms. For this reason, standard food handling practices have been developed
to minimize the potential for microbial growth in foods. The Bacillus thuringiensis
isolates examined in the cited study, above, produce much less diarrheal toxin than
the verified toxigenic Bacillus cereus.   The Centers for Disease Control  and
Prevention has recently compiled morbidity data for food-borne diseases. For the
five year period from 1988 through 1992,the average number of reported outbreaks
per year attributed to Bacillus cereus is 4.2 and the proportion of the total is
0.64%.  No  deaths were,attributed  to these outbreaks.  Thus  the incidence of
reported disease  due to Bacillus cereus  is a very small amount of the total
food-borne diseases. For these reasons, the Agency  believes that the current uses
of Bacillus thuringiensis are not likely to contribute to the prevalence of diarrhoea
induced by microbial toxins hi improperly stored processed food.  The Agency will
continue to survey the scientific literature, including publications from the Centers
for Disease Control on incidents of Bacillus food poisoning, and will reexamine
these conclusions if valid evidence  is found that suggests a direct association
between Bacillus thuringiensis usage and illness.  In addition,  the  Agency
emphasizes that, under section 6 (a)(2) of the Federal Insecticide Fungicide and
Rodenticide Act, registrants  are  required to report any information regarding
unreasonable adverse effects following registration and these effects would clearly
fall under this provision.

       c.    Effects on the Immune and Endocrine Systems

       The Agency is not requiring information on the endocrine effects of this
microbial pesticide at this time; the Food Quality Protection Act has allowed three
years after August 3, 1996, for the Agency to implement a screening program with
respect to endocrine effects.  However, the Agency  has considered, among other
relevant factors, available information concerning whether Bacillus thuringiensis
may have an effect hi humans similar to an effect produced by a naturally occurring
estrogen or other endocrine effects.   No known toxins or metabolites of Bacillus
thuringiensis  have   been  identified   to  act  as  endocrine   disrupters   or
immunotoxicants. Therefore, adverse effects to the endocrine or immune systems
are not expected.

                              13

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2.     Dietary Exposure and Risk Characterization

       The use patterns for Bacillus thuringiensis may result in dietary exposure
with possible residues of the bacterial spores on raw agricultural commodities.
However, hi the absence of any toxicological concerns, risk from the consumption
of treated commodities is not expected for both the general population and infants"
and children.

3.     Occupational,  Residential, School and Daycare Exposure and  Risk
Characterization

       a.    Occupational Exposure and Risk Characterization

       The application methods suggest that  the potential for eye,  dermal and
inhalation exposure to mixers, loaders and applicators does exist.  The label for
Bacillus thuringiensis based products may recommend wearing gloves, goggles,
and.a dust mask or equivalent pulmonary tract covering.  However, because of a
lack of mammalian toxicity, the risk from occupational exposure is minimal. No
additional exposure data or changes in the proposed labels to restrict exposure are
recommended at this time.
                                               i
       b.    Residential,   School  and   Daycare  Exposure   and   Risk
Characterization

       No indoor residential, school or daycare uses currently appear on the label.
Nondietary exposure to these other use sites  could occur where children are
present, but the health risk is expected to be negligible due to: (1)  The lack  of
toxicological concerns associated with Bacillus  thuringiensis, and (2) Bacillus
thuringiensis has been used as  a pesticide for approximately 50 years with no
known adverse  effects.
4.     Drinking Water Exposure and Risk Characterization

       There is minimal potential for Bacillus thuringiensis to enter ground water
or other drinking water sources, and the bacterium does not proliferate in aquatic
habitats.  Thus, the potential for drinking water exposure is negligible (section IE
(C) (3)(e), Environmental Assessment, Water Resources).  In addition, the health
risk is expected to be negligible due to: (1)  The lack of toxicological concerns
associated with Bacillus thuringiensis, and (2) Bacillus thuringiensis has been used
as a pesticide for approximately 50 years with no known adverse effects.
                             14

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              5.      Acute  and Chronic  Dietary  Risks  for  Sensitive  Subpopulations
              Particularly Infants and Children

                     A battery of acute toxicity/pathogenicity studies is considered sufficient by
              the Agency to perform a risk assessment for microbial pesticides. Furthermore,
              the  Bacillus thuringiensis delta-endotoxins affect  insects  via a well  known
              mechanism in which they bind to unique receptor sites on the cell membrane of the
              insect gut, thereby forming pores and disrupting the osmotic balance.  There are
              no known equivalent receptor sites hi mammalian species which could be affected,
              regardless of the age of the individual.  Thus, there is a reasonable certainty that
              -no harm will result to infants and children from dietary exposure to residues of
              Bacillus thuringiensis.

              6.      Aggregate Exposure from Multiple Routes Including Oral, Dermal and
              Inhalation
                                 f

                     Bacillus thuringiensis is a naturally  occurring  soil bacterium.  Anyone
              coming in contact with the soil is likely to  be exposed to this microorganism.
              Because the health risk is expected to be negligible for oral, dermal, and inhalation
              exposure routes,  as  stated above, aggregate  exposure by  these  routes,  from
              naturally-occuring populations in the soil and from the use of pesticidal products,
              should not pose a threat to human health.
DISCUSSION:
                  ;
       The  intraperitoneal injection data and the other product characterization information
submitted for reregistration are adequate to corroborate the lack of pathogenicity/toxicity
associated with many years of use of the previously registered active ingredients and no further
toxicology data are required for previously registered technical grade of the active ingredient.
However, acute toxicity studies continue to be part of the data requirements for end-use and
manufacturing-use products. These may  be new studies or registrants may  cite previously
submitted studies.
                                           15

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       C.     Environmental Assessment

       There are no outstanding data requirements.  The available data from the literature and
from the sum total of all submissions is sufficient for the Agency to make an assessment of the
environmental effects for the currently registered uses of Bacillus thuringiensis.

              1.     Ecological Toxicity Data

                     The Agency concludes  that toxicity and  infectivity risks due to delta-
              endotoxin  effects  to  nontarget   avian,  freshwater  fish,  freshwater  aquatic
              invertebrates, estuarine and marine animals, arthropod predators/parasites, honey
              bees, annelids and mammalian wildlife will be minimal to nonexistent at the label
              use rates of registered B. thunngiensis active ingredients. However, other toxins
           •   which may be produced by Bacillus thuringiensis can produce adverse direct toxic
              effects on nontarget species.  Mitigation measures to alleviate these risks  are
              specified hi Section IV. Despite the potential for immediate toxic effects on target,
              and possibly some nontarget,  organisms, there is no  evidence that Bacillus
              thuringiensis can cause epizooatics hi the field. A summary of the studies reviewed
              for the formal ecological assessment, by delta-endotoxin source, is provided below.
              Although the studies submitted  in support of reregistration are adequate to make
              an ecological  assessment for the  intrinsic delta-endotoxin-based properties of
              Bacillus thuringiensis, the Agency's inability to assess the potential for nontarget
              effects by the exotoxin(s) from the available data has resulted in the  following
              decisions.  (1) Based on all available data, the Agency is waiving the ecological
              effects data requirements for the reregistration of Bacillus thuringiensis.  (2) The
              Agency has concluded  that  there will be no  potential for  adverse effects on
              nontarget organisms for B.  tkuringiensis-based products if the the presence of
              soluble, heat labile exotoxins and beta-exotoxin is minimized.  (3) However, the
              production process must be closely controlled and monitored or certified to assure
              these  exotoxins  are not present  at levels  that  can  cause significant  adverse
              ecological effects.

                     a.     Toxicity to Terrestrial Animals

                            (1)    Birds, Acute and Subacute
                                            16

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Table 1   B. thuringiensis subspecies kurstaki
GUIDELINE
NUMBER
154-16
water fowl
(mallard duck)


!
upland game
bird
(bobwhite quail)

-
MRID
NUMBER
414434-03
435830-03
416570-08
417511-08
414434-04
435830-02
416570-07
417511-09
RESULT
Practically nontoxic after 2.9 g/kg/day for 5 days
Practically nontoxic after 1.6 g/kg/day for 5 days
Practically nontoxic after 2.5 g/kg/day for 5 days
LC50 > 1.8 x 1010 spores/kg
Practically nontoxic after 2 9 g/kg/day for 5 days
Practically nontoxic after 1.6 g/kg/day for 5 days
Practically nontoxic after 2.5 g/kg/day for 5 days
LCSO > 1.8 x 1010 spores/kg
Table 2   B. thuringiensis subspecies israelensis
GUIDELINE
154-16
mallard

bobwhite

MRID
414390-05
418427-02
414390-06
418427-03
RESULT
Practically nontoxic after 3.1 g/kg/day for 5 days
Practically nontoxic after 5 ml/kg/day for 5 days
Practically nontoxic after 3.1 g/kg/day for 5 days
Practically nontoxic after 5 ml/kg/day for 5 days
Table 3   B. thuringiensis subspecies tenebrionis
\ GUIDELINE
1 154-16 mallard
| 154-17 mallard
1 MRID
1 404974-09
1 404974-10
RESULT |
No mortality following a single 10 g/kg dose 1
No mortality after 3 mg/kg injection 1
                                            17

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Table 4   B. thuringiensis subspecies aizawai
GUIDELINE
154-16
mallard

bobwhite

MRID
419943-14
419748-05
419943-13
419748-04 '
RESULT
LC50 > 16.7 g/kg
LC50 > 8570 mg/kg
LC50 > 16.7 g/kg
LC50 > 8570 rag/kg
       The avian study results summarized above  indicate that B.  thuringiensis subspecies
kurstaki, B. thuringiensis subspecies israelensis, B. thuringiensis subspecies tenebrionis and B.
thuringiensis subspecies aizawai are not toxic or pathogenic to the northern bobwhite quail or
mallard duck after acute or subacute testing. No additional avian testing is required to support the
current B.  thuringiensis delta-endotoxin reregistration effort.  No avian respiratory data were
submitted hi response to the Registration Standard.  Although avian respiratory data had been
required by the Standard, these data are not currently needed to support reregistration.
                            (2)     Birds, Chronic
                                                                  i
                                   Due to the lack of toxicity/pathogenicity in the acute and
                            subacute testing, avian chronic  study requirements  were not
                            triggered for Bacillus thuringiensis delta-endotoxins.
                            (3)     Mammals

                                   The acute toxicity studies performed on the laboratory rodent
                            with different Bacillus thuringiensis subspecies indicate that there
                            are not likely to be any adverse effects on wild mammals.  The wild
                            mammal studies are required only  when toxicology  data  are
                            inadequate for assessment of hazard to wild mammals.

                            (4)     Insects
                                   (a) Nontarget Insect Susceptibility
                                            18

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Table 1  B. thuringiensis subspecies kurstaki
GUIDELINE
154-23
154-24
predaceous
neuroptera


parasitic
hymenoptera
-

predaceous
coleoptera
arthropod
predators and
parasites
honey bee



MRID
435830-10
416570-11
417511-11
414434-11
435830-08
417511-10
416570-13
435830-09
417511-12
414434-10
414434-09
419835-01
419833-01
435681-01
434917-02
RESULT
NOEL = 3000 ppm
practically nontoxic at 1 x 10s cfu/g food for 9 days; NOEL = 1 x
108 spores/g diet
practically nontoxic at 1.2 x 108 spores/g diet for 5 days; NOEL >
1 .2 x 108 spores/g diet
slightly toxic; lOx field rate resulted in 18% mortality
practically nontoxic at 3000 ppm of food for 15 days; NOEL =
3000 ppm
practically nontoxic at 2.4 x 108 spores/ml diet for 23 days; NOEL
> 2.4 x 108 spores/ml diet
practically nontoxic at 1 x 108 spores/g diet for 30 days; NOEL =
1 x 10s cfu/g
NOEL = 1500 ppm, slightly toxic
practically nontoxic at 2.4 x 108 spores/ml diet for 28 days; NOEL
> 2 4 x 108 spores/ml diet
Slightly toxic (6.2 g/L resulted in 12 to 21 % mortality)
Toxic; lOx field rate resulted in 100% mortality within '6 days
48-hour LD50 > 23.2 ug/bee; NOEL = 7.7 ug/bee
48-hour LD50 > 23.2 ug/bee; NOEL = 7.7 ug/bee
10-day LC50 118 ug/bee (consumed)
No significant effects noted at lOx field rate
                                            19

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Table 2  B. thuringiensis subspecies israelensis
GUIDELINE
154-23

1 154-24
green lace-wing
larvae
parasitic
hymenoptera
predaceous
coleopteran
honey bee '
MRID
418427-08
418427-09
418427-10
418427-11
RESULT
16-day LCJO > 1.5 x 108 cfu/g diet; 16-day NOEL = 2 5 x 10"
cfu/g
30-day LC50 > 7.9 x 107 cfu/g diet
9-day LC50 > 1.8 x 108 cfu/g diet
5-day LCJO > 7.0 x 107 cfu/g diet
Table 3  B. thuringiensis subspecies tenebrionis (CrylllA)
GUIDELINE
154-24

Honey bee
larvae
Earthworm
MRID
441247-02
441247-01
RESULT
NOEL = > 100 ppm (lOOx field cone.) (18 day
test)
NOEC = > 100 ppm (120x in 1 kg soil)
(14 day test)
Table 4  B. thuringiensis subspecies aizawai
GUIDELINE
154-23


154-24
green lace-wing
larvae

parasitic
hymenoptera
predatory mite
predaceous
coleoptera

Honey bee
MRID
419943-21
422453-01
419943-19
419748-09
419943-20
429421-01
419748-08
RESULT
NOEL = 10,000 ppm
Toxic to larvae at lOx field rate
NOEL = 100 ppm
Ix field rate resulted in 24% corrected mortality
NOEL = 10,000 ppm
NOEL = 1566 ppm
Highly toxic; LEJO = 15 ppm
                     With the exceptions of MRIDs 414434-09 and 422453-01, the nontarget
              insects, thuringiensis subspecies kurstaki, B. thuringiensis subspecies israelensis,
                                           20

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B. thuringiensis subspecies tenebrionis (CrylUA) and B. thuringiensis subspecies
aizawai studies show little to no toxicity or pathogenicity in the tested neuroptera,
hymenoptera,  coleoptera,  arthropod and annelida group indicator species.  The
above  honey bee data indicate a high degree of toxicity for B.  thuringiensis
subspecies aizawai and minimal toxicity for B. thuringiensis subspecies kurstaki,
B. thuringiensis subspecies israelensis and B. thuringiensis subspecies tenebrionis.

       With the exception of honey bee and earthworm testing, all of the nontarget
insect  studies  listed above were graded as supplemental.  However,  since the
Agency currently  waives the requirement for  nontarget  insect data (but .not
honeybee testing) for registration, no additional data are required. These data are
routinely waived because Bacillus thuringiensis does not cause epizooatics in the
field; it functions by a toxic mode-of-action.

                    (b) Target Insect Host Range Susceptibility

       B.  thuringiensis  subspecies are differentiated by their pesticidal activity
against insects.  Generally,  only insect species  within one order (Lepidoptera,
Coleoptera, Diptera, and Orthoptera) are susceptible to a given insecticidal delta-
endotoxin protein.   Therefore, insect susceptibility  results  provide general
information about the delta exotoxin(s) expressed by a particular B. thuringiensis
strain.

       The submitted data on insect susceptibility to the various B. thuringiensis
subspecies and varieties are summarized below.

     1  As expected, B. thuringiensis subspecies aizawai strains displayed minimum
activity to Coleoptera (0% to 5%) and Orthoptera (0% to 7.5%) species, some
activity against Diptera (0% to 57%), and the greatest activity towards Lepidoptera
(100%).

       Two of threeS. thuringiensis subspecies israelensis strains exhibited strong
activity against Diptera (80%  and 100%) with  one strain displaying minimum
efficacy (20%). Minimum activity against Lepidopter an (2.6%, 13.3%, and 28%),
Coleopteran (2.8%, 4%,  10%), -and Orthopteran  (0%  to  6.4%)  species was
observed for all B. thuringiensis subspecies israelensis  strains.

       B.  thuringiensis subspecies kurstaki displayed the greatest activity against
Lepidopteran (95% and 100%) species and limited activity against Coleopteran
(0%, 5%, and 17.5%) and Orthopteran (0% and 20%) species. Although three
strains displayed strong activity (100%) against Manduca sexta, a Lepidopteran
species, one strain exhibited minimum activity (7.9 %) when bioassayed against the
same insect at the same dose level.  Two of the seven B. thuringiensis subspecies

                             21

-------
              kurstafd strains exhibited a range, of activity (30% and  100%)-against Aedes
              aegypti, a Dipteran species.

                     B.  thuringiensis subspecies tenebrionis  was active against  Coleoptera
              (100%) with only slight activity (3.1 %) observed againstM. sexta, a Lepidopteran
              species.
                     b.     Toxicity to Aquatic Animals

                           (1)    Freshwater Fish
Table 1  B. thuringiensis subspecies kurstaki -
GUIDELINE
154-19
trout


bluegill
. MRID
414434-06
418991-01
416570-09
414434-05
RESULT
LC50 > 1.5 x 10'° cfu/1
Practically nontoxic; Aqueous LC50 > 4.9 ul/1 and oral LC50 > 2.5
nl/goffood
practically nontoxic with an aqueous LC50 > 4.6 x 10'° cfu/1 of
dilution water
practically nontoxic at 1.5 x 1010 cfu/1 of dilution water and at 1.2 x
10'° cfu/g of food for 32 days
T'a'ble 2  B. thuringiensis subspecies israelensis
GUIDELINE
154-19
trout

bluegill

MRID
414390-08
419801-05
414390-07
418427-04
RESULT
Aqueous LC50 > 8.7 x 109 cfu/1; oral LC50 > 1.7 x 10'° cfu/g food
Slightly toxic
Aqueous LC50 > 1.4 x 10'° cfu/1; oral LC50 > 5.3 x 109 cfu/g food
Aqueous LC50 > 8.9 x 109 cfli/I; oral LC50 > 1.3 x 10'° cfu/g food
Aqueous LC50 > 1.6 x 1010 cfu/1; oral LC50 > 4.3 x 109 cfu/g food
                                           22

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Table 3  B. thuringiensis subspecies tenebrionis
GUIDELINE
154-19 trout
1 MRID
1 404974-11
RESULT
Aqueous NOEC = 100 mg/I
	          I
Table 4  B. thuringiensis subspecies aizawai
GUIDELINE
154-19
trout >

MRID
419943-15
419749-03
RESULT
Aqueous LC50 > 3.9 x 107 cfu/ml; oral LC50 > \.5\ 10'° cfu/g
food
96-hour LC50 > 100 mg/1 . ||
       With aqueous LC50's ranging from 8.7 x 109 to 4.6 x 1010 cfu/1, no toxicity or pathogenicity
was evident in the bluegill or the rainbow trout with the B. thuringiensis subspecies kurstaki, B.
thuringiensis subspecies israelensis, B. thuringiensis subspecies tenebrionis and B. thuringiensis
subspecies aizawai,

                            (2)    Freshwater Invertebf ates
                                  Table 1  B. thuringiensis subspecies kurstaki
GUIDELINE
154-20
=====
daphnia

MRID
414434-07
418991-02
RESULT
moderately toxic; 21-day LC50 is between 5 ppm and 50 ppm
aqueous LC50 > 4.9 ul/1
Table 2  B. thuringiensis subspecies israelensis
GUIDELINE
154-20 daphnia
1 MRID
1 414390-09
RESULT - . ||
moderately toxic; 21-day LC50 is between 5 ppm and 50 ppm ||
                                            23

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Table 3  B. thuringiensis subspecies tenebrionis
GUIDELINE
154-20 daphnia
1 MRID
1 404974-12
RESULT
48-hour ECSO > 100 mg/1
Table 4  B. thuringiensis subspecies aizawai
GUIDELINE
154-20
daphnia

MRID
419943-16
419748-02
RESULT
Highly toxic; 21-day NOEC = 6.4 x 108 cfu/1*
Highly toxic; 21-day estimated ECSO is 0.8-2.7 ppm
       With LCSO estimates  between -5  and 50 ppm, the data indicate that B. thuringiensis'
subspecies kurstaki and B. thuringiensis subspecies israelensis are moderately toxic to daphnia.
B. thuringiensis  subspecies  aizawai  studies (MRIDs 419943-16 and 419748-02) with  EC50
estimates ranging from 0.8 to 3 ppm, demonstrate a high level of toxicity to aquatic invertebrates.
In all cases examined, the toxicity was due to-factors other than the delta-endotoxin.
                           (3)
Estuarine and Marine Animals
Table 1  B. thuringiensis subspecies kurstaki
GUIDELINE
154-21


grass shrimp


sheepshead
minnow


copepod
MRID
435830-07
418991-03
415408-02
435830-06
418991-04
415408-01
414434-08
RESULT
Practically nontoxic; NOEL > 3.6 x 107 cfu/g food
Aqueous LCJO > 4.9 ul/1; oral LCSO > 2.5 nl/g food
NOEL > 2.9 x 109 cfu/g diet
Practically nontoxic; aqueous LCJO > 4.9 x 1010 cfu/1; oral LCSO >
3.7 x 107 cfu/g food
Aqueous LCSO > 4.9 ul/1; oral LCSO > 2.5 nl/g food
aqueous and oral NOELs are > 2.9 x 1010cfu/ml and > 2.9 x 109
cfu/g, respectively
NOEL = 500 mg/kg sediment
                                         .  24

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Table 2  B. thuringiensis subspecies israelensis
GUIDELINE
54-21




grass shrimp

sheepshead
minnow

copepod
MRID
415404-02
418427-06
415404-01
418427-07
414390-10
RESULT
NOEL > 2.0 x 10'° cfu/g food
practically nontoxic; NOEL > 4.2 x 109 cfu/g food
NOEL > 2.0 x 10'° cfu/g food; oral LC50 > 2 x 1010 cfu/g food
practically nontoxic; LCSO > 7.2 x 109 cfu/g food
NOEL = 50 mg/kg sediment
Table 3  B. thuringiensis subspecies aizawai
GUIDELINE
154-21

grass shrimp
sheepshead
minnow
MRID
419943-18
419943-17
RESULT
NOEL > 1.6 x 1010 cfu/g food
aqueous LC50 > 1.6 x 10'° cfu/g food; oral LCSO > 1.6 x 1010 cfu/g
food
       The estuarine and marine studies performed with B. thuringiensis subspecies kurstaki, B.
thuringiensis subspecies israelensis and B. thuringiensis subspecies aizawai do not demonstrate
toxicity or pathogenicity to the copepod, grass shrimp or sheepshead minnow.

                     c.     Toxicity to Plants

                            Although 'non-target  plant toxicity  testing was  required in the
                  x   Registration Standard, these data are being waived to support reregistration,
                     because a review of the literature on  B. thuringiensis and its byproducts
                     indicate no known detrimental effects on plant life, including Terrestrial,
                     Semi-aquatic and Aquatic plant life.
              2.
Exotoxin Effects
                     Nontarget organism toxicity has not been found with delta-endotoxins when
              these are separated from the bacterial growth medium.   _Specifically,  data
              submitted to the Agency in support of registrations involving plants genetically
              engineered to express delta-endotoxins show that the pure Cry delta-endotoxin does
              not exhibit detectable deleterious effects upon nontarget species. A number of B.
              thuringiensis fermentation-based products tested at high dose levels have shown
              intrinsic toxicity  to nontarget organisms. Investigations conducted to determine
                                            25

-------
what is responsible for the nontarget activity have implicated heat-labile soluble
substances contaminating the technical material. Toxic effects have been seen in
aquatic invertebrateDaphnia magna, the honeybee, some beneficial insects and fish
(rainbow trout, bluegill) and wild mammal (mouse and rat) studies, with Daphnia
being the most sensitive indicator of toxicity.  The impurities are found hi the
supernatant fluids separate from the delta-endotoxins. The toxicity does not appear
to be due to the heat stable beta-exotoxin since autoclaving of the test material
renders the supernatant fluids innocuous.

       The heat-labile, soluble  toxic impurities have thus  far been seen  in B.
thuringiensis subspecies kurstaki, aizawai, and israelensis,  but may possibly be
present in other B. thuringiensis varieties. A journal article reports varying levels
of at least one soluble exotoxin in all commercial B. thuringiensis products tested
(H. Damgaard. 1995. FEMS Immunology and Medical Microbiology 12:245-250).
B. thuringiensis subspecies aizawai-based products show the  greatest negative
effects on nontarget organisms.  With B. thuringiensis subspecies kurstaki, the
manifestation of the toxin(s) appears to be at least partly related to production
methodology, especially the composition of the growth media used in industrial
fermentation.

3.     Environmental Fate

       Formal environmental fate data is not  generally required for  microbial
pesticides because it is not usually needed and it is difficult to evaluate  due to the
potential for microbial growth under suitable environmental conditions.  However,
the behavior of Bacillus thuringiensis and  related bacilli has been thoroughly
studied and is well known.  With regard to risk characterization it is known that B.
thuringiensis toxins degrade rapidly hi the phyllosphere as a  result of exposure to
UV light. B. thuringiensis toxins may persist in soil for several months,  yet a half-
life for typical B. thuringiensis products on foliage is approximately 1-4 days. As
a result, exposure to most above-ground nontargets organisms is expected to be
minimal.   B. thuringiensis  spores,  which are  nontoxic,  may persist in the
environment, yet infection of insects from environmental dose levels is minimal.

4.     Exposure and Risk Characterization

       The available  data  and  published  literature  indicate  that certain B.
thuringiensis  products  containing   fermentation   by-products   may  cause
toxicity/pathogenicity in daphnia,  the honey bee and other  nontarget  beneficial
insects. Since B. thuringiensis formulations used mainly for terrestrial application
are not expected to appear at significant levels hi aquatic environments, daphnia
sensitivity to these subspecies,  (kurstaki, aizawai and tenebrionis) does not pose
an aquatic environmental concern, although percautionary labeling may be required

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for some uses to ensure that no inadvertent exposure occurs. (However, daphnia
studies are a useful screen for terrestrial species and may indicate that additional
testing is justified.) In contrast, B. thuringiensis subspecies israelensis is typically
applied to water for mosquito control.  As a result, aquatic invertebrate sensitivity
is more likely to need to be addressed through label mitigation or by minimization
of  soluble exotoxin  production depending  on the production (manufacturing
process) testing (see section V(A)(l)(b)).

       a.      Exposure and Risk to Nontarget Terrestrial Animals

              Due to the relatively short insecticidal half-life of B. thuringiensis
       spores and crystals, the exposure and subsequent risk to nontarget wildlife
       is limited to the time immediately after application. B. thuringiensis delta-
       endotoxin  has  a direct adverse  effect  on  the  target  insect   orders
       (Lepidoptera, Coleoptera, Diptera), but susceptibility varies widely among
       individual  species.  Any  one registered  product has  a narrow susceptible
       insect range.,In general,  published literature shows a temporary reduction
       in susceptible  insect populations during the use period. Beneficial insects
       and avian  and mammalian predators are slightly impacted because of
       reduced food source. Unlike with alternative chemical pesticides, however,
       no significant population impact from the use of B. thuringiensis products
       is noted. Furthermore, alternative chemical pesticides may have additional
       direct adverse effects on birds, mammals, and nontarget insects that are not
       observed with the use of B. thuringiensis products.

              (1)     Birds

                     Any  effects  of  B.  thuringiensis  delta-endotoxin  on
              insectivorous"birds is due to a reduction of food supply. Birds that
              feed on caterpillars in the spring will have a reduced number of prey
              on which to feed for a short time. This forces a  switch in the diet.
              The number of nesting  attempts per year may be reduced but not
              necessarily the number  of fledglings per breeding territory in the
              year of application or subsequent years.            ' -

                     No toxicity or pathogenicity to avian species was seen in the
              studies submitted in support of this  reregistration. Based on these
              results, no unreasonable risk to avian species is  expected from the
              label uses of the registered B. thuringiensis products as long as the
              production process  is properly controlled _to prevent  nontarget
              effects due to exotoxins.
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(2)    Mammals

       Mammals, including bats, that feed on susceptible insects
might be affected indirectly by reductions in food abundance. This
may trigger  a switch in  diet.  Unlike  with many conventional
pesticides, however, they are not affected by ingestion of moribund
insects.

       The submitted rodent data and the anticipated low exposure
of mammalian wildlife during use of these microbial pest control
agents indicates that risk to wild mammals from the label uses of
Bacillus thuringiensis is minimal to nonexistent as long as  the
production process  is properly controlled to prevent nontarget
effects due to exotoxins.

(3)    Insects

       The use of B. thuringiensis delta-endotoxin results in a
temporary reduction hi susceptible insect populations.  In forest
uses, there is a significant decrease hi numbers of adult and larval
Lepidoptera the year of spray,  with some reductions extending into
the following year hi species whose susceptible life stage occurs in
the year previous to the appearance of adults. B. thuringiensis delta-
endotoxin does  not,  however,  affect the  overall abundance of
arthropods,  including beetles, sucking  insects  such as  aphids,
leafhoppers,  or cicadas and spiders.  Direct toxicity to terrestrial
insect predators and parasites has not been noted hi  any studies
except some  low-level mortality hi a laboratory study at doses
higher than the recommended  label use rates. Any effect on insect
predators and parasites appears to be indirect.  Field studies on
insects other than the target pests and their parasites and predators
have found few other species of groups that are affected. Among the
susceptible nontarget insect populations that are adversely affected
during  prolonged B. thuringiensis delta-endotoxin applications,
recovery takes place soon after cessation of pesticide use.

       Direct toxicity to honeybees has  been shown for some
strains.   Exposure  to honeybees could occur,  but  the  risk is
considered minimal since the  pesticide is not considered toxic to
adult honeybees at the label use rates. If excessive toxicity is seen
hi any  subsequent product testing,  labeling will be required to
reduce exposure to honeybees.
                28

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              Based on these results, the risk to nontarget beneficial insects
       is expected to be "minimal to nonexistent from the label uses of
       registered B.  thuringiensis products  as  long as the production
       process is properly controlled to prevent nontarget effects due to
       exotoxins.

b.     Exposure and Risk to Nontarget Aquatic Animals

       (1)     Freshwater Fish

              Field   studies   on  B.   thuringiensis   delta-endotoxin
       contaminated water found no observable effects on resident fish
       behavior and reproduction. Consumption of delta-endotoxin treated
       insects has not affected fish to any noticeable degree. Fish that feed
       on susceptible insects may be affected indirectly by reductions in
       food abundance. While no toxrcity data are available on reptiles and
       amphibians, B. thuringiensis delta-endotoxin is not believed to pose
       a hazard to these organisms.

              No toxicity' or pathogenicity was seen in studies submitted
       in support of this reregistration.  As  a  result, no unreasonable risk
       to freshwater fish is expected from the label  uses of registered B.
       thuringiensis  products as long as the production process is properly
       controlled to  prevent nontarget effects  due to exotoxins.


       (2)     Freshwater Invertebrates

              B. thuringiensis delta-endotoxin has no appreciable effect
       on aquatic invertebrates. Field studies have concluded that there is
       no adverse effect  on the  abundance and composition of benthic
     '  insects.   Immature  and  adult  stages of mayflies, caddisflies,
       dragonflies,  damselflies,  beetles, midges,  and dobsonflies are
       unaffected. Studies on application of  B. thuringiensis subspecies
       kurstaki  to a forest stream showed  no measurable effects on the
       microinvertebrate community composition or abundance. A brief
      . reduction inpopulations of mayfly, blackfly and stonefly was noted.

              Moderate to high levels of toxicity to daphnia was- seen in
       studies submitted in support of this reregistration.  This toxicity was
       attributed to factors other than delta-endotoxin. However, the risk
       to daphnids and other aquatic invertebrates is considered minimal to
       nonexistent based on currently registered label use rates because the

                       29

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       environmental concentration is lower than the observed laboratory
       effect levels.  However, some products may require labeling to
       reduce  exposure if the  exotoxin levels can not be  sufficiently
       controlled during the manufacturing process. Based on these results,
       no freshwater aquatic invertebrate hazard is expected from the label
       uses of registered  B.  thuringiensis  products  as  long  as the
       production process is properly controlled to prevent higher levels of
       nontarget toxicity due to the exotoxins.

       (3)    Estuarine and Marine Animals

              B. thuringiensis delta-endotoxin is not expected to have any
       adverse effects on estuarine and marine  animals because of lack of
       toxicity  and exposure.  Invertebrates  in  marine  and  estuarine
       ecosystems  are not effected by B. thuringiensis delta-endotoxin.
       Published studies report no effect to oysters, mussels, shrimp, and
       periwinkles.

              No toxicity or pathogenicity was seen in studies submitted
       in support  of this reregistration.   Based on  these  results, no
       unreasonable risk to estuarine and marine animals is expected from
       the label rate uses of currently registered B. thuringiensis products
       as long as the production process is properly controlled to prevent
       nontarget effects due to exotoxins.

c.     Exposure and Risk to Nontarget Plants

              In order for B. thuringiensis delta-endotoxin to have a toxic
       effect,   it must  be  ingested  by  an organism and  exposed to
       appropriate  digestive enzymes at a pH  of 9.0 to 10.5. Therefore
       terrestrial, semi-aquatic or aquatic plants are unaffected by Bacillus
       thuringiensis delta-endotoxin because plants have no mechanism for
       its ingestion. In addition, the Agency has found no reports of any
       adverse plant effects caused  by  any other toxins  that  might be
       produced by strains of Bacillus thuringiensis despite the extensive ,
       pesticidal use of Bacillus  thuringiensis on  plants.   An indirect
       beneficial effect on plants exists  as a result  of reduction in plant
       damaging insect populations.

d.     Endangered Species

              Based on the toxicity and exposure  data there will not be a
       "may effect" situation for endangered mammals, birds, plants and

                       30

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                           noninsect aquatic species: All endangered/threatened insect species
                           that are susceptible to the  Bacillus thuringiensis delta-endotoxins
                           may be adversely affected if exposed.

                    e.   Water Resources
      j
                         _  (1)    Surface Water

                                  Bacillus thuringiensis occurs naturally in soils worldwide.
                           Applications of B. thuringiensis formulations do not increase levels
                         -  of B.t. in soil,  and B. thuringiensis spores and crystals persist for
                           a relatively short time. As all soil microbes, B. thuringiensis does
                           not percolate through the soil and its presence is confined to the top
                           10 niches of soil. Thus no ground water contamination concerns are
                           present.

                         -  (2)    Degradation

                                  The microorganism Bacillus thuringiensis (B. thuringiensis)
                           is ubiquitous in many soils throughout the world. B. thuringiensis
                           is not known as an aquatic bacterium, and therefore is not expected
                           to proliferate in aquatic habitats.  Although the potential exists for
                           a minimal amount of the B. thuringiensis which is applied to enter
                           ground water or other drinking water sources, the amount would in
                           all  probability be undetectable or more than several orders of
                           magnitude lower than those  levels which are  tested and are
                           considered necessary for safety. Moreover, Bacillus thuringiensis
                           is not considered to be a risk to drinking water.  Drinking water is
                           accordingly not being screened for B. thuringiensis as a potential
                           indicator of microbial  contamination or as a  direct pathogenic
                           contaminant. Low percolation through soil and municipal treatment
                           of drinking water would reduce the possibility of exposure to B.
                           thuringiensis through drinking water. The protein delta-endotoxin
                           is quickly degraded by soil microorganisms. Therefore, the potential
                           of significant transfer to drinking water is minimal to nonexistent.

       D.     Product Performance (Efficacy) Assessment

       The Agency has waived all requirements  to submit efficacy data for  review unless the
pesticide product bears a claim -to control  pests that pose  a threat to human health.  Bacillus
thuringiensis is used to control one  class  of public health pests, i.e.  mosquitoes.   Product
performance data for these uses have not been reviewed for this  Reregistration Eligibility
Document because they are conducted on the end-use products.  These assessments will be done

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during product reregistration using the data submitted in response to the Data Call-in associated
with this Reregistration Eligibility Document.
IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.     Determination of Eligibility
                                                                                     i
              Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
       of relevant data concerning an active ingredient, whether products containing the active
       ingredients 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 Bacillus thuringiensis active ingredients. 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 Bacillus thuringiensis.
       Appendix B identifies the generic data requirements that the Agency reviewed as part of
       its determination of reregistration eligibility of Bacillus  thuringiensis,  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 Bacillus thuringiensis and to determine that Bacillus thuringiensis can
       be used without resulting in unreasonable adverse effects to humans and the environment,
       providing that an approved manufacturing process be used hi order to minimize or
       eliminate the production of certain toxic unintentional ingredients.  The Agency therefore
       finds that all products containing Bacillus thuringiensis as the active ingredients 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,  and the data identified in
       Appendix B.   Although the Agency has found that all uses of Bacillus thuringiensis 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 Bacillus thuringiensis, if new information comes to the
       Agency's attention  or if the data requirements for registration (or the guidelines for
       generating such data) change.

              1.     Eligibility Decision

                     Based on the reviews of the generic data for the active ingredients Bacillus
              thuringiensis, the Agency has sufficient information on the health effects of
              Bacillus thuringiensis and on its potential for causing adverse effects in fish and
                                      «•
                                           32

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       wildlife  and the environment.   The  Agency  has  determined" that Bacillus
       thuringiensis products,  manufactured,  labeled and used as  specified in this
       Reregistration Eligibility Decision, will not pose unreasonable risks or adverse
       effects to humans or the environment.   Therefore, the Agency concludes that
       products  containing   Bacillus  thuringiensis  for all  uses  are  eligible  for
       reregistration.

       2.     Eligible and Ineligible Uses

              The Agency has  determined that all uses  of Bacillus thuringiensis are
       eligible for reregistration.

B.     Regulatory Position

       The following is a summary of the regulatory positions and rationales for Bacillus
thuringiensis. Where labeling revisions  are imposed, specific language is in Section V.

       1.     Tolerance Reassessment (40 CFR 180.1011 and 40 CFR 180.1001(c))

              An exemption from the requirements for a tolerance is currently established
       for Bacillus thuringiensis in or on beeswax and honey and all other raw agricultural
       commodities when it is applied either to growing crops, or when it is applied after
       harvest in accordance with good agricultural practices (40 CFR §180.1011).  In
       addition,  there is a tolerance exemption (40 CFR I80.1001(c))  for Bacillus
       thuringiensis fermentations  solids  and/or  solubles.    The  absence  of any
       toxicological/pathogenicity concerns for oral mammalian exposures to Bacillus
       thuringiensis warrants continuation of these exemptions  as  long as. the proper
       quality control procedures are performed as described hi Section V(A)(l)(a) of this
       Reregistration Eligibility Document.

              The specific language in the tolerance exemption, 40 CFR 180.1011, dates
       from  1971 and  does  not reflect current  taxonomy  designations for Bacillus
       thuringiensis- isolates.   This exemption  also  includes the  quality  control
       specifications for production of Bacillus thuringiensis designed to prevent changes
       in  characteristics  of   the   active   ingredient,   contamination  with  other
       microorganisms, and/or presence of detectable levels of beta-exotoxin or other
       mammalian toxins.  These batch  testing requirements for production of food use
       Bacillus thuringiensis should also apply to nonfood uses that are not subject to the
       40  CFR  1011  tolerance exemption.   Therefore,  these  production testing
       requirements will now be required under the product analysis data requirements ha
       40 CFR 158.740(a) and will apply to all registered isolates and all uses of Bacillus
       thuringiensis.  An additional benefit of this appearing hi only one place is that if
       the Agency needs to modify these production batch tests it will only have to change

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the product analysis requirements for Bacillus thuringiensis. To ensure that the
production batch tests requirements do not lapse for any products, the Agency will
repropose the tolerance exemptions following publication of this Reregistration
Eligibility Document.

2.     Risk Mitigation

       a. Mitigation Measures for Dietary, Occupational and Residential Risk

       The potential risk to humans from dietary, non-dietary and occupational
exposures of the delta-endotoxins and most of the cellular components of Bacillus
thuringiensis are considered negligible.   However,  direct  exposure to dry,
anhydrous preparations have caused eye irritation effects and those products must
require protective eye equipment on the lable to reduce eye exposure.

       The Agency is concerned about the potential for the production of various
undesirable Bacillus exotoxins for environmental effects because their synthesis
appears to depend on unpredictable aspects of the composition of the fermentation
media or growth conditions. These toxins may be inducible toxins, dependent on
the presence of certain chemicals being present to turn on the biochemical pathway
to synthesize them, they may be toxic metabolites, requiring the presence of certain
chemicals for their synthesis, or their synthesis may depend on physical growth
parameters such as temperature. Production batch testing is required in order to
detect some of these toxins and to detect contamination by pathogenic bacteria.
These quality  control testing requirements  are described in section V, Actions
Required by Registrants. In addition, as described in the Registration Standard,
there may be  a potential for strains of Bacillus thuringiensis to produce beta-
exotoxin during subsequent growth in formulated products, despite none being
detected in production  batches.   If the organism is capable of producing beta-
exotoxin, the registrant  should ensure that none is present in the TGAI and that the
product is not put in a medium, including formulated end use products that allows
germination and/or growth at any time prior to use.  End use product testing
options for beta-exotoxin  are  discussed in  section V, Actions  Required  by
Registrants.

       b. Mitigation Measures for Nontarget Organisms (Plants and Wildlife),
or Ground and Surface Water Contamination

       As described in the environmental assessment, section ni(C), there should
be no unreasonable adverse effects on nontarget organisms, or ground or surface
water contamination concerns, from the delta-endotoxins and most of the cellular
components of Bacillus thuringiensis when used according to currently approved

                             34

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label rates. The assessment assumed that the Bacillus thuringiensis was produced
in accordance with the quality control testing required for each batch produced.
However, the Agency has no information on whether the current battery of tests
will detect the heat labile exotoxins that have been detected in various non target
species tests,  but would like to minimize their presence in the product. A Daphnia
magna test using a 10 day exposure period appears to be the most sensitive assay
of those we have reviewed. This test will be required to certify each manufacturing
process as described in section V, Actions Required of Registrants.

3.     Endangered Species Statement

       Currently, the Agency is developing a program ("The Endangered Species
Protection Program") to identify  all  pesticides whose use may cause adverse
impacts on  endangered  and threatened species and to implement  mitigation
measures that will eliminate the adverse impacts. The program would require use
restrictions to protect endangered  and  threatened species  at the county  level.
Consultations with the Fish and Wildlife Service may be necessary to assess risks
to newly listed species or from proposed new uses. In the future, the Agency plans
to publish a description of the Endangered Species Program in the Federal Register
and have  available voluntary county-specific bulletins.. Because the  Agency is
taking this approach for protecting endangered and threatened species,  it  is not
imposing  label  modifications at  this time- through the RED.   Rather,  any
requirements for product use modifications will occur in the future under the
Endangered Species Protection Program.

4.     Labeling Rationale

       In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act,
section 2(n)(l), the label of each pesticide product must bear a statement which
contains the "name and percentage of each active ingredient, the  total percentage
by weight of all inert ingredients; ...". Bacillus thuringiensis manufacturers have
attempted to meet this requirement by using arbitrary conversions from potency
units or by various chemical assay methods as previously specified by the Agency.
(Tompkins,  et al.  1990). However, because there is  no longer any public
organization to standardize bioassays and the chemical assays do not adequately
reflect potency (see section 6, below), EPA will no longer require these  methods
to be used to satisfy the legally mandated label  statement.  Instead,  a conversion
factor will be used to determine the actual weight per spore-crystal  or cell-toxin
complex to use in calculating a percent active ingredient for the concentration of
the spore-crystals  or cell-toxin  complexes  in the products.  In order to  avoid
misleading the consumer, the label must state that the percent active ingredient
                             35

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value is not necessarily related to the pesticidal activity of Bacillus thuringiensis-
based products.

       In addition to the percent active ingredient value, above, the label must
identify the active ingredient as Bacillus thuringiensis.   Furthermore, all toxins
and/or chemical substances that are present at levels that are known to contribute
to the efficacy of the product against the target pest(s) must be listed on the label.
This is particularly  important in order to allow  consumers  to select the most
appropriate product for use  in  conjunction with the plants that  express
delta-endotoxins  derived from Bacillus  thuringiensis or with other  Bacillus
thuringiensis-based microbial pesticides.  In addition, the strain identity and a
nationally-recognized culture collection accession number must appear in  the
Confidential Statement of Formula and may be placed on the label.

5.     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.

6.     Product Performance (Efficacy) Reassessment

       The Agency has an established policy that the  submission of efficacy data
may be waived, unless the pesticide bears a claim to control pests that pose a threat
to human health.  However, even if the submission of the efficacy data is waived,
each registrant must ensure through testing that his products are efficacious when
used in accordance with the label directions and commonly accepted pest control
practices.   The Agency reserves the right to require, on a  case-by-case basis,
submission of efficacy data  for  any  pesticide  registered or  proposed  for
registration/reregistration.

Public Health Uses:  In this case,  the registrants of all Bacillus  thuringiensis
products with label claims to control mosquitoes, blackflies, or other public health
pests, are required to either submit/cite product performance (efficacy) data, or
delete the  label claims for controlling these pests as part of product reregistration. _

Public Health  and Non-public  Health  Uses: Because the efficacy of Bacillus
thuringiensis products may vary greatly from one production batch to another, each

                              36

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              production batch must be analysed for potency.  The results of these studies should
              not be routinely submitted to the Agency for review, but must be available if the
              Agency requests the the data on a case-by-case basis. The potency (killing power)
              must be assessed using a bioassay procedure for the following reasons:

                    Industry has also used chemical analysis methods to quantify the amount of
              the delta-endotoxins present in their products. However chemical analysis methods
              do not measure the quality of the toxins which may vary widely in their potency
              between different production batches. In addition, there are factors other than the
              delta-endotoxins that contribute  to the efficacy  of some Bacillus thuringiensis
              products.  The spores may germinate and establish an infection secondary to the
              direct toxic damage. Other toxins, such as the recently-described VipSA (Estruch,
              et al., 1996. VipSA, a novel Bacillus thuringiensis vegetative insecticidal protein
              with a wide spectrum of activities against lepidopteran insects, Proc.  Natl. Acad.
              Sci. USA 93:5389-5394), may have activity similar to, or may be synergistic to,
              the delta-endotoxins.  The genetic control of toxin synthesis may also affect the
              activity of the  toxins, e.g. in some cases the delta-endotoxin is  synthesized
              throughout the growth cycle of the cell rather than during spore formation.  None
              of these factors can be accounted for by the chemical analysis methods.

                    Industry originally used a bioassay,  using a standarized culture of Bacillus
              thuringiensis subspecies kurstaki  (HD-1)  and  a  standard  susceptible  insect,
              Trichoplusia ni, to establish the potency which was expressed hi International
              Units. However, the use of the term "international units" may, hi some cases, not
              be appropriate because there is no longer a publicly-available standardized bioassay
              or standarized cultures.  In addition, the proliferation of Bacillus thuringiensis
              isolates that express new types of delta-endotoxins have expanded the range of
              target organisms so that different insect species may have to be used.   In the
              absence of a public organization to oversee standarization of these assays, industry
              must be responsible for maintaining appropriate internal standards for these assays.
              It should be noted that these assays can no longer be relied on to compare one
              company's products with products from another company.
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.

       A.     Manufacturing-Use Products

              This section specifies the  data requirements and  responses necessary for the
       reregistration of manufacturing-use products which, for Bacillus thuringiensis, include

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additional  confirmatory generic data for reregistration of the TGAI."   These  data
requirements apply also to end use products for which there is no manufacturing-use
product.

       1.     Additional Generic Data Requirements

              The generic data base supporting the reregistration of Bacillus thuringiensis
       for all uses has been  reviewed and determined to be substantially complete.
       Because of potential variation in production batches, confirmatory data are needed
       to ensure that no unintentional ingredients, e.g. toxins, are present at significant
       levels. These additional data are specified in Appendix D, the Generic Data Call-in
       Notice.

              a.     Qualitity Control Manufacturing Process Data Requirements

              Each production batch must be tested by at least the following tests as
       originally listed in the tolerance exemption, 40 CFR 180.1011.  The Agency
       recognizes that better tests may be developed to detect undesirable toxic
       contaminants and encourages submission of such tests for evaluation by Agency
       scientists. If more appropriate tests are found acceptable, the Agency will allow
       registrants to substitute them for currently required tests or may modify these
       quality control test requirements for all registrants.

              A new manufacturing process must be submitted that includes a description
       of the qualitity control  procedures as follows.

       Quality Control Testing Required for each Production  Batch:    (1)  Bacillus
       thuringiensis shall be  produced by pure culture fermentation  procedures with
       adequate control measures during production to detect any changes  from the
       characteristics of the parent strain or contamination by other microorganisms. (2)
       Each production batch, prior to the addition of other materials, shall be tested by
       subcutaneous injection  of at least 1 million spores, or equivalent for asporogenic
       strains, into each of five laboratory test  mice weighing  17 grams to 23  grams.
       Such test shall show no evidence of infection or injury in the test animals when
       observed for 7 days following injection.  ("Evidence of infection or injury" is any
       indication of either systemic or localized infectivity  or toxicity) (3) Production
       batches shall be free of the Bacillus thuringiensis beta-exotoxin when tested with
       the  fly larvae toxicity  test ("Microbial Control of Insects and Mites."  R.P.M.
       Bond,  et  al., p.280ff.,  1971).   This specification  can be satisfied either by
       determining that each  master seed lot brought into production is a Bacillus
       thuringiensis strain  which  does  not produce beta-exotoxin   under  standard
       manufacturing  conditions or by  periodically  determining that beta-exotoxin
       synthesized during the manufacturing process  is eliminated by the subsequent

                                    38

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manufacturing process procedure(s). (If the organism is capable of producing beta-
exotoxin, the registrant should ensure that none is present in the TGAI and that the
product is not put in a medium, including formulated end use products that allows
germination and/or growth at any time prior to use.) Some registrants have been
authorized to use an HPLC method instead  of the fly larvae test.   In order to
reconfirm the accuracy of Agency records, those registrants must resubmit, or cite,
their request to use HPLC and the supporting data to show that the method is at
least as sensitive as the fly larvae test.

       In  addition to  the above testing for undesirable components  of each
production batch, each production batch must be analyzed for potency by bioassay
because the efficacy at Bacillus thuringiensis products may vary greatly from one
production batch to another.  The results of these studies should not be routinely
submitted to the Agency for review, but must be available if the Agency requests
the data on a case-by-case basis.

       b.      Standardization of Manufacturing Process

       Registrants must  optimize  and control their  manufacturing  process
sufficiently  to  prevent production of significant  amounts  of  the  heat  labile
exotoxins.  The manufacturing process  must include the fermentation medium
composition and the growth conditions. In lieu of requiring SL Daphnia test on each
production batch, as an indicator of the heat labile exotoxin levels, a representative
sample of the active ingredient from each manufacturing process is to be tested by
a Daphnia study incorporating a 10 day exposure period using a maximum hazard
dose.  If the test shows significant lethality, a dose response Daphnia test must be
performed to derive an LC50.

       A  specific, detailed  description  of the  manufacturing process  and the
Daphnia testing must be submitted for approval by the Agency. Further testing or
mitigation measures may be required following Agency review (Figure 1).

2.     Labeling Requirements for Manufacturing-Use Products

       To remain hi 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 an Insecticide for the following use(s) [fill blank
       only with those uses that are being supported by  MP registrant]."

An MP registrant may, at his/her discretion, add one of the following statements

                             39

-------
to an MP label under "Directions for Use" to permit the refonhulation 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 requirements  regarding
       support of such, use(s)."

       In Addition, for Bacillus thuringiensis manufacturing use products, a "point
source discharge"  is a possibility - where  effluent from the manufacturing plant
may contain Bacillus  thuringiensis  or toxic  fermentation byproducts.    The
following National Pollutant Discharge Elimination System (NPDES) statement (as
outlined  in Pesticide Regulation  (PR) Notice 93-10 (Reference: PR-93-10)) is
required on such products:

"Do not discharge effluent containing this product into lakes,  streams, ponds,
estuaries, oceans, or other waters unless in accordance with the requirements of a
National Pollutant Discharge  Elimination System  (NDPES)  permit and  the
permitting authority has been notified in writing prior to discharge.  Do  not
discharge effluent  containing this product to  sewer systems without previously
notifying the local sewage treatment plant authority.  For  guidance contact your
State Water Board or Regional Office of the EPA."

       Further, P.R. Notice 95-1 (Reference: PR-95-01) exempts certain products
(i.e., products in containers of less than 5 gallons (liquid), less  than 50 pound?
(solid, dry weight) and in aerosol containers  of any  size)  from bearing effluent
discharge statements specified by  P.R. Notice 93-10.  P.R. Notice 93-10 still
applies to the following kinds of pesticide  products that may result in discharges
to the waters of the United States or to municipal sewer systems, including but not
limited to: (A) all technical grade and manufacturing use products; and (B) end-use
products packaged hi containers equal to or greater than 5 gallons (liquid) or 50
pounds  (solid, dry weight), and  registered  for industrial preservative,  water
treatment, other industrial processing uses (such as cooling tower water systems,
pulp and paper mill water systems, secondary oil recovery injection water systems,
food processing operations, leather tanning, wood protection and textile treatment)
and commercial and institutional uses (including, but not limited to, hospitals,
hotels/motels, office buildings and prisons).

                             40

-------
                         The exemption of certain containers from the labeling requirements of P.R.
                  Notice 93-10 does not  relieve a producer or user  of such products from the
                  requirements of the Clean Water  Act or state or local requirements.	

                       Figure 1.  Testing standardized manufacturing process.
            Test representative manufacturing process with
                           Daphnia study
                               Negative
                   No more data needed
                   No additional labeling
                                      Positive   1
     Eco effects: Risk issue - may affect nori target organisms from toxin present in product
       Determine LC50 in a Daphnia study to allow a quantative risk assessment
                                                       i
                  If LC50/risk is high
          Test other non-target species
          to determine proper labeling
             and/or mitigate (below)
                   If LCsn/risk is low
                                                     "50'
                     No further testing or
                      labeling is needed
                                  I
Reevaluate uses in
 order to reduce
    exposure
Inactivate toxin
    genes

 Optimize manufacturing
process to minimize  toxin
       production
                                               41

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B.     End-Use Products

       1.     Additional Product-Specific Data Requirements

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

              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.  In
       addition to the conventional data requirements, a storage stability study is required
       for certain end-use products, and, in cases where claims are made for controlling
       public health pests, product performance studies are required to be submitted.

              a.      Conventional Data Requirements                             }

                    Product Analysis  data  and  Acute  Toxicology  data  must be
              submitted, or cited, to support all manufacturing-use and  end-use products.
              The Acute Toxicology data consists  of an acute oral toxicity study in the
              rat, an acute dermal toxicity study, and acute inhalation toxicity study in the
              rat,  a primary eye irritation study in the  rabbit, and a primary dermal
              irritation study. On a case-by-case basis, the Agency may accept waivers
              for some of  these data requirements based on the known toxicity of the
              ingredients or other arguments provided by the registrant.  For example,
              the Agency may accept a proposal to require goggles when the product may
              be predicted  to cause adverse eye effects as for a dry hydroscopic powder
              or silica containing formulations.  In other cases, a particular study may not
              be needed because the formulations contain well characterized ingredients
              that are not likely to present an unreasonable risk.

              b.      Storage Stability Study

                   . The Registration Standard of 1989 asked for a storage stability study
              for end use products to determine concentrations of beta-exotoxin because
              the Agency suspected that beta-exotoxin may be formed  in certain end use
              products subsequent to formulation.   Many registrants requested waivers
              because they did not believe their product would support microbial growth.

                                    42

-------
       The  Agency considered these requests  and we have now  established
       standards for requiring the storage stability studies as follows. A storage
       stability study will -be required for all aqueous products that can support
       gram positive bacterial growth. If the storage stability studies were already
       submitted in response to the Registration Standard, they may be cited.

       c.  Product Performance (Efficacy)

              The Agency has waived all requirements to submit efficacy data for
       review unless the pesticide product bears a claim to control pests that pose
       a threat to human health.   Thus,  product performance data must  be
       submitted or cited for ^Bacillus thuringiensis products that have mosquito,
       blackfly, or  other public  health  pest  control uses.    This product
       performance data requirement may be satisfied by submission of a properly
       controlled  potency  test  as  discussed  in  section  IV(B)(6) of this
       Reregistration Eligibility Document.

2.     Labeling Requirements for End-Use Products

       a.  Percent Active Ingredient

              Because there currently is no accountable way to factor potency into
       the required label statement, EPA will no longer require potency as part of
       the legally mandated label statement. The following method will be used
       to provide a conversion'factor for the weight of an "active" unit for use in
       converting the product concentration to satisfy the FIFRA requirements: A
       laboratory culture of the bacterium is grown in a  soluble medium, such as
       trypticase soy broth, and when the culture sporulates and lyses,  the number
       of spores per mililiter  (ml)  is determined  by  standard bacteriological
       counting methods.  In the case where the Bacillus thuringiensis toxins are
       being produced in a non-spore forming bacterium, the number of vegetative
       cells per ml would be determined.  Then concentrate the spore-crystal or
       cell-toxin complex by  centrifugation or filtration, dry the concentrate, and
       determine the weight hi  grams of the dry spore-crystal  or cell-toxin
       complex.    The percent  active  ingredient  by  weight  for Bacillus
       thuringiensis-based products must then be calculated for label purposes by
       determining the number of spores or cells per gram of product, multiplying
       that  value  by the weight of an individual spore-crystal  or cell-toxin
       complex, and multiplying that value by 100.
                             ,43

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c. Potency Determination

       The label for both public health and non-public health uses may
include potency  statements; however, in  accordance  with 40  CFR
156.10(a)(5)(ii), the statement must not be false or misleading.  See section
IV(B)(6) of this Reregistration Eligibility  Document for guidance  in
conducting appropriate tests.

d. Worker Protection Standard

       Any  product  whose  labeling  reasonably  permits use  in the
production of an  agricultural plant on any farm, forest, nursery,  or
greenhouse must comply with the labeling requirements of PR Notice 93-7,
"Labeling Revisions Required by the Worker Protection Standard (WPS)",
and PR Notice 93-11, "Supplemental Guidance for PR Notice 93-7", which
reflect the requirements  of EPA'  s  labeling regulations for  worker
protection statements (40 CFR part  156,  subpart K). These labeling
revisions are necessary to implement the Worker Protection Standard for
Agricultural Pesticides  (40  CFR part 170)  and must be completed  in
accordance with, and within the deadlines specified in, PR Notices 93-7 and
93-11. Unless otherwise specifically directed in this RED, all statements
required by PR Notices 93-7 and 93-11 are to be on the product label
exactly as instructed in those notices.

       After April 21,  1994, except as otherwise provided in PR Notices
93-7 and 93-11, all products within the scope of those notices must bear
WPS PR Notice complying labeling when they are distributed or sold by the
primary registrant or any supplementally registered distributor.

       After October 23,1995, except as otherwise provided in PR Notices
93-7 and 93-11, all products within the scope of those notices must bear
WPS PR Notice complying labeling when they are distributed or  sold by
any person.

       The labels and  labeling of all products must comply with EPA's
current regulations and requirements as specified in 40 CFR §156.10 and
other applicable notices.

e.  Other

       (1)    A respiratory protection statement must appear on the label
       for different uses as follows:
                      45

-------
 100 x conversion factor x  Number of units/gram in the product = % active ingredient by weight

The conversion factor is "Weight (grams)/unit" and a unit is either one spore-crystal complex or one
                                  cell-toxin complex.
                          In order to avoid misleading the consumer, a statement must appear
                   on the label below the percent active ingredient value: "There is no direct
                   relationship between intended activity  (potency) and the Percent Active
                   Ingredient by Weight."

                   b. Active Ingredients

                          In addition to the percent active ingredient value, above, the label
                   must identify the active ingredient as Bacillus thuringiensis.  Furthermore,
                   all toxins and/or chemical substances that are present at levels that are
                   known to contribute to the efficacy of the product against the target pest(s)
                   must be listed on the label.  This is particularly important hi order to allow
                   consumers to select the most appropriate product for use hi conjunction
                   with  the plants  that  express delta-endotoxins  derived  from  Bacillus
                   thuringiensis or with other Bacillus Ihuringiehsis-based microbial pesticides.
                   In addition, the strain identity and a nationally-recognized culture collection
                   accession number must appear hi the Confidential Statement of Formula and
                   may be placed on the label. At this time, the Agency recommends that the
                   delta-endotoxins be  classified hi accordance with the standards  being
                   developed  by the Bacillus thuringiensis  delta-endotoxin  nomenclature
                   committee which was set up hi 1993  hi order to update the nomenclature
                   originally devised hi 1989 by Hofte and Whiteley (Microbiological Reviews
                   53:242-255). This new nomenclature is based on the similarities between
                   the full length toxin sequences rather than on the assessment of biological
                   properties.  References to this new nomenclature  may be found  at (1)
                   Revision of the Nomenclature for the Bacillus thurhigiensis Pesticidal cry
                   Genes. N. Crickmore, D. R. Zeigler, J.Feitelson, E. Schnepf, B. Lambert,
                   D. Lereclus, J. Baum and D.H.  Dean (1995) In: Program and  Abstracts
                   of the 28th Annual Meeting of the Society for Invertebrate Pathology. p!4.
                   Society  for Invertebrate  Pathology,  Bethesda,  MD,  and  (2)  Bacillus
                   thurhigiensis delta-endotoxin nomenclature N. Crickmore, D.R. Zeigler,
                   J.Feitelson, E. Schnepf, D. Lereclus, J. Baum, J. Van Rie and D.H. Dean
                   (1997) WWW site: http://epunix.biols.susx.ac.uk/ Home/Neil_Crickmore/
                   Bt/ index.html. At such time the new nomenclature is validly published and
                   accepted, the Agency may  require it to be used for delta-endotoxin
                   classification.
                                          44

-------
(a) Agricultural Use Products

The personal  protective equipment  (PPE)  section must
include the statement:

"As a general precaution when exposed to potentially high
concentrations of living microbial products such as this, all
mixer/loaders and applicators must wear a dust/mist filtering
respirator meeting NIOSH standards of at least N-95, R-95,
or P-95."

Registrants may add the following  engineering control
statements to the PPE section if they so choose:

"When handlers use closed systems, 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."

PPE for early entry in the Agricultural Use Requirements box
remains unaffected.

(b) Non-Agricultural Use Products not Used Around the
Home

Either the PPE section or the precautionary statements of the
Hazards to Humans and Domestic Animals section must
include the statement:

"As a general precaution when exposed to potentially high
concentrations of living microbial products such as this, all
mixer/loaders and applicators not in enclosed cabs or aircraft
must wear  a dust/mist filtering respirator meeting NIOSH
standards of at least N-95, R-95, or P-95."

(c) Domestic (Home) Use Products

Either the PPE section or the precautionary statements of the
Hazards to Humans and Domestic Animals section must
include the statement:

"As a general precaution when exposed to potentially high

         46

-------
              concentrations of living microbial products such as this, wear
              a dust particle mask when mixing or applying this product."

       (2)     All commercially applied products  with  directions  for
       outdoor terrestrial uses must have the following statements hi the
       Environmental Hazards  section:
                         \                   _
     1                   i
       "Do not apply directly to water, or to areas where surface water is
       present or to intertidal areas below the mean high water mark.  Do
       not contaminate water when cleaning equipment or "disposing of
       equipment washwaters."       •                     -  „

              This statement should be preceded by "For terrestrial uses,"
       if the product has aquatic sites hi addition to terrestrial, forestry
       (except aerial application) and/or domestic  outdoor  uses.' This
       revised statement would then not apply to other general use patterns
       —  aquatic (e.g.,  mosquito larvicides or  adulticides, aquatic
       herbicides, piscicides, slimicides, etc.), greenhouse and indoor uses.
       The "For terrestrial uses,"  qualifier is not  allowed  on products
       which allow aerial  application  to  forests  but  which  have'  no
       approved aquatic use sites.

       (3)     For residential consumer products, the required statement is:

       "Do not apply directly to water.  Do not contaminate water when
       disposing  of equipment washwaters or rinsate."

       (4)     For direct water application uses, the required statement is:

       "Do not apply directly to treated, finished drinking water reservoirs
       or drinking water receptacles."

f.   Spray Drift Labeling

The following language must be placed on each product label that can be
applied aerially:

       "Avoiding spray drift at the  application site is the responsibility of
the applicator. The interaction of many equipment-and-weather-related
factors determine the potential for spray drift.  The applicator and the
grower are responsible for considering all these factors when making
decisions."
                       47

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Page Intentionally Blank

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       The following drift management requirements must-be followed to
 avoid off-target drift movement from aerial applications to agricultural field
 crops.  These requirements do not apply to forestry applications, public
 health uses or to applications using dry formulations.

 1.     The distance of the outer most nozzles on the boom must not exceed
 3/4 the length of the wingspan or rotor.

• 2.     Nozzles must always point backward parallel with the air stream and
 never be pointed downwards more than 45 degrees.

 Where states have more stringent regulations, they should be observed.

       The applicator should be familiar with and take into account the
 information covered in the Aerial Drift Reduction Advisory Information.

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

 [This section is advisory hi nature and does not supersede the mandatory
 label requirements.]

       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. Apply ing  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.

                      48   .

-------
•      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 hi  low  relative  humidity,  set  up
                                                         s
                      49

-------
              equipment to produce larger droplets  to  compensate for evaporation.
              Droplet evaporation is most severe when conditions are both hot and dry.

              TEMPERATURE INVERSIONS

                     Applications should not occur  during  a temperature inversion
              because drift potential is high. Temperature inversions restrict vertical air
              mixing, which causes small suspended droplets to remain in a concentrated
              cloud.  This cloud can move in unpredictable directions due to the light
              variable winds common during  inversions.  Temperature  inversions are
              characterized by increasing temperatures with altitude and are common on
              nights with limited cloud 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).

C.     Existing Stocks

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

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

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VI. APPENDICES
       51

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Page Intentionally Blank
               52

-------
APPENDIX A.  Use Sites for the Reregistration of 0247
                                        i
Bacillus thuringiensis  Case #0247  Quantitative Usage Analysis
Site
Blackberries
Blueberries
Cranberries
Raspberries
Strawberries
Citrus, Other
Grapefruit
Lemons
Oranges
Apples
Pears
Pome-Like Fruit, Other
Avocados
Nectarines
Apricots
Cherries
Peaches
Plums & Prunes
Grapes
Almonds
Pecans
Walnut
Acres
(000)
Grown
5
59
29
11
51
51
194
63
867
572
78
-58
82
29
19
128
212
140
825
429
488
205
Acres Treated (000) %
Weighted
Average Max
1
4
4
3
8
1
0
0
21
19
1
3
1
10
4
4
11
8
43
38
11
2
2
11
9
11
15
2
1
0
39"
50
5
14
3
22
8
8
23
25
86
64
30
5
of Crop Treated
Est Weighted Est
Average Max
19%
1%
13%
30%
16%
1%
0%
0%
2%
3%
1%
5%
1%
34%
20%
3%
',5%
6%
, 5%
9%
2%
1% "
45%
18%
32%
100%
31%
3%
0%
0%
4%
9%
6%
24%
3%
74%
39%
6%
11%
18%
10%
15%
6%
2%
1.0
5.4
1.0
1.7
1.0
1.0
1.3
1.0
1.0
1.9
1.0
1.2
1.0
1.0
1.0
1.5
1.7
1.2
1.6
1.8
1.2
1.1
States of Most Usage
(% of total Ibai
# appl used on this site)
/year


CA 100%
CA 100%
CA 100%
CA 100%
WA MI OH
CA CO WA
CA 100%
CAFL
CA

WACANY
CA91%






AZ81%
100%




86%

CA OR 100%
CA 82%
CA 100%


' TXOKAL81%
CA 100%

 Vegetables, Bulb

 Eggplant
 Peppers

 Celery
 Greens
 Kale
 Lettuce  -
 Spinach
 Parsley

 Broccoli
 Cabbage
396
16
44
11%
2.0
CA EL 86%
4
235
37
2
6
268
19
2
114
85
1
27
17
1
0
56
8
0
22
33
3
45
24
0
0
100
16
1
29
43
28%
11%
46%
46%
0%
21%
40%
15%
19%
39%
79%
19%
65%
0%
0%
37%
87%
66%
26%
51%
4.2
5.4
1.0
4.4
1.0
2.0
. 1.0
1.0
1.1
1.4

FLTXCA
-
AZMI

CAAZFL

CA



84%
,


85%




                   Acres
          Acres Treated (000)  % of Crop Treated  ,
                                    States of Most Usage
                                        53

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Site
Cauliflower
Collards
Cucumbers
Squash
Cantaloupes
Melons, Honeydew
Watermelons
Artichokes
Asparagus
Beets
Potatoes
Roots/Tubers
Sweet Corn
Tomatoes
Beans/Peas, Dry
Beans/Peas, Green
Com
Barley
Oats/Rye
Rice
Sorghum
Wheat, Spring
Wheat, Winter
Hay, Other
Pasture
Alfalfa
Peanuts
Soybeans
Sunflower
Cotton
Sugar Beets
Sugarcane
Other crops
Tobacco
(000)
Grown
58
11
146
53
113
27
258
9
88
12
1,421
244
784
500
2,181
723
72,284
7,505
6,133
2,921
11,280
20,799
45,854
33,427
86,960
23,949
1,610
62,879
2,745
12,689
1,415
852
2,515
695
Weighted
Average
13
4
11
1
16
2
11
9
3
0
20
9
3
91
6
13
151
1 "
0
1
0
2
1
0
29
54
2
88
3
377
4
0
16
32
Max
22
8
28
4
32
6
21
9
9
-1
45
17
6
171
33
23
381
6
1
2
0
9
1
0
100
89
6 .
275
9
787
14
0
27
47
Est
Average
23%
31%
8%
1%
14%
6%
4%
93%
3%
2%
1%
4%
0%
18%
0%
2%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
3%
0%
0%
1%
,5%
Weighted Est
Max
38%
67%
19%
7%
28%
22%
8%
100%
10%
7%
3%
7%
1%
34%
2%
3%
1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%_
6%
1%
0%
1%
7%
1.9
1.0
1.0
1.0
1.0
1.7
1.0
1.0 -
1.0
1.0
3.6
3.6
1.3
3.9
1.1
2.6
1.1
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
2.3
1.0
1.0
3.2
1.4
(% of. total Ib ai
# appl used on this site)
/year









CANYOHORTXWI.%
RIMACTVA85%
FLTN91%
MA FL MI NC CA MD 76%
FLCAAL83%
CA FL 100%
FLGAAZKY83%
NECOOHFLIL81%
ND 100%

LA, 100%

ND 100%
WV 100%
FL 100%
OK 100%
CAAZ93%

MS LA 89%
ND CA 100%
ALMSLATXAR81%
ND88%
FL100%
CAND88%
NC GA FL 89%
54

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Site
Agricultural total
Nursery & Greenhouse
Woodland
Water
Crp Acres-long term
Idle Cropland
Acres
(000) ,
Grown
1,350
3,717
62,825

68,617
7,461
Acres Treated (000) % of Crop Treated States of Most Usage
fOf «•£ +~*«l lu „.
Weighted
Average Max
2,138
30 50
0 0
unknown, probably
1 1
0 2
Est Weighted
Average

1% 1%
0% 0%
not significant
0% 0%
0% 0%
Est # appl used on this site)
Max /year

1.0
1.8

1.0
1.4 LA 100%
    Landscape maintainance
    Lots/Farmsteads          49,630
    Public health (mosquito control)  '
    Rights of way
    Structural pest control
    Non agricultural total
    Total
2,632
unknown, probably not significant
2        4          0%     0%
1,250    1,500
spot treatments, amount unknown
unknown, probably not significant

1,283    1,420

3,558
                                                    3.6
NHCACOLAMN85%
    COLUMN HEADINGS
    Weighted average—the most recent years and more reliable data are weighted more heavily.
    Est Max = Estimated maximum, which is estimated from available data.
    Average application rates are calculated from the weighted averages.

    NOTES ON TABLE DATA
    Usage data primarily covers 1987 - 1996.
      Calculations of the above numbers may not appear to agree because they are displayed as rounded:
        to the nearest 1000 for acres treated or Ib. a.i. (Therefore 0 = < 500)
        to the nearest whole percentage point for % of crop treated. (Therefore 0% = < 0.5%)

      0* = Available EPA sources indicate that no usage is observed in the reported data for this site, which implies that there is
little or no usage.
      A dash (-) indicates that information on this site is NOT available in EPA sources or is insufficient.
      * Other/Crop Groups
      Bulb Crops include garlic, leeks, and onions.
      Citrus, Other includes kumquats, limes, tangelos, and tangerines.
      Cucurbits includes cucumber, squash, and pumpkin.
      Nut Trees, Other includes chestnuts, filberts, hazelnuts, hickory nuts, macadamia nuts, pistachios, lychie nuts, and palm.
      Pome-Like Fruit, Other includes figs, kiwifruit, persimmons, pomegranates, carambolas, and papaya.
      Root and Tuber Crops include red beets, carrots, horseradish, parsnips, radish, rutabagas, sweet potatoes, turnips, and yams.
      Other crops include popcorn and rapeseed/canola

      SOURCES:  EPA data, USDA, and National Center for Food and Agricultural Policy
                                                           55

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Page Intentionally Blank
             56

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                                  GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active ingredients
within the case 0247 covered by this Reregistration Eligibility Decision Document. It contains generic
data requirements that apply to 0247 in all products, including data requirements for which a "typical
formulation"  is the test substance.

    The data table is organized in the following format:
                           v

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

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

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

    3. Bibliographic citation (Column 3).  If the Agency has acceptable data in its files, this column lists
the identifying number of each study.  This normally  is the Master Record  Identification (MRID)
number, but may be a "GS" number if no MRID number has been assigned.  Refer to the Bibliography
appendix for  a complete citation of the study.
                                             '57

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                                     APPENDIX B
      Data Supporting Guideline Requirements for the Reregistration of Baciltis thuringiensis

REQUIREMENT	USE PATTERN	  CITATION(S)
PRODUCT CHEMISTRY
885.1100          Product Identity
                                All
885.1200
Manufacturing Process
All
885.1300
Formation of Unintentional Ingredients  All
885.1400
Analysis of Samples
All
 .   41439001, 41459403, 41429701,
     41435401, 41751101, 42015901,
41441501-31, 41444601-41, 41459401,
      41459402, 41459404, 41429601
     41439001, 41459403, 41429702,
     41435401, 42080101, 42015901,
  41490801-03, 41459401, 41459402,
              41459404, 41429602

     41439001, 41459403, 41429703,
     41435401, 41751102, 42015901,
  41490801-03, 41459401, 41459402,
              41459404, 41429603

     41439002, 41880001, 41980101,
     41429703, 41939901, 41435402,
     41883801, 41751103, 42015901,
     41789701, 41653901, 41657002,
   '  41646702, 41429603, 41939901
                                               58

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       Data Supporting Guideline Requirements for the Reregistration of Bacittis thuringiensis
REQUIREMENT
                                    USE PATTERN
                                    CITATION(S)
885.1500
885.1600
'   Certification of Limits/Analytical
   Methods
   Physical & Chemical Limits
TIER I TOXICOLOGY
885.3050           Acute Oral Toxicity/Pathogenicity
885.3150  ,         Acute Pulmonary
885.3200
885.3400
   Toxicity/Pathogenicity
   Acute Intravenous -
   Toxicity/Pathogenicity
   Hypersensitivity Incidents
All
All
All
All

All

All
41439002, 41980101, 41429703,
41435402, 41751104, 42015901,
41789701, 41653901, 41657002,
         41646702, 41429603

41439002, 41503903, 41429704,
41435402, 42080102, 42015901,
41429704, 41653901, 41503902,
          41503904, 41429604
                    waived1
                    waived1

                    waived1

                   42027101
                                                  59

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            Data Supporting Guideline Requirements for the Reregistration of BacilHs thuringiensis

    REQUIREMENT                                           USE PATTERN                         CITATION(S)

    NON-TARGET ORGANISMS

    885.4050            Avian oral pathogenicity/toxicity -       ABD                                  Conditionally waived2

    885.4200            Freshwater Fish toxicity/pathogenicity -  ABD                                  Conditionally waived2
                         trout

    885.4240            Freshwater Invertebrate                 ABD                                  Conditionally waived2
                         toxicity/pathogenicity

    885.4280            Estuarine and Marine animal -           ABD                                  Conditionally waived2
                         toxicity/pathogenicity

    885.4300            Nontarget plant studies                  ABD                                              Waived2

    885.4340            Nontarget insect testing                 ABD                                  Conditionally waived2

    885.4380            Honey bee testing                      ABD                                  Conditionally waived2


1.  Toxicology studies have been waived based on the sura total of all toxicology studies submitted to the Agency, the scientific literature, and the lack
of any reports of significant human health hazards despite considerable exposure from years of use of Bacillus thuringiensis products.

2.  Nontarget Organism studies have been either waived, or conditionally waived, based on the sum total of all nontarget organism studies submitted to
the Agency, the scientific literature, and the lack of any reports of significant adverse effects on nontarget organisms despite considerable exposure from
years of use of Bacillus thuringiensis products.  Because Agency data shows a potential for Bacillus thuringiensis to produce exotoxins that can adversely
affect nontarget organisms, and the manifestation of these appears to be at least partly related to production methodology, a representative product sample
for each specific manufacturing process will be tested by a Daphnia test as a screen to rule out excessive exotoxin systhesis. Additional nontarget studies
may be required to certify any manufacturing process that results in  significant levels of toxicity to Daphnia.
                                                              60

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 APPENDIX C.  Citations Considered to be Part of the Data Base Supporting the
                                 Reregistration of 0181

                                 GUIDE TO APPENDIX C

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

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

3. IDENTIFICATION OF ENTRIES. .The entries hi 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 to4dentify volumes of submitted studies (see paragraph 4(d)(4)
   below for further explanation). In a few cases,  entries added to the bibliography late hi the
   review may be preceded by a nine character temporary identifier. These entries are listed after
   all MRID entries.  This temporary identifying number is also to be used whenever specific
   reference is needed.

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

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

   b.                     Document date.  The date of the study is taken directly from the

                                             61

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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 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 (in addition to any self-explanatory text)
the following elements describing the earliest known submission:

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

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

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

(4)    Volume Identification (Accession Numbers).  The  final element
       in the trailing parentheses identifies the EPA accession number
      "of the volume in which the original submission of the study
       appears. The six-digit accession number follows the symbol
       "CDL," which stands for "Company Data Library."  This
       accession number is in turn followed by an alphabetic suffix
       which shows the relative position of the study within the
       volume.
                  62

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   MRID
          BIBLIOGRAPHY
              CITATION
00066178
00066179
00090207
00090208
00096527
00096529
 Williams, W.L.; Esposito, R.G.; Hernandez, H.G. (19??) To
 Determine the Effect of Intra-peritoneal Injection of Biotrol 10W on
 Weight Gain and Mortality of Mice: Experiment Nutrilite Products,
 Inc. #1 (504-1). (Unpublished study received Jan 4, 1977 under
 6296-13; submitted by Nutrilite Products, Inc., Buena Park, Calif.;
 CDL:230811-A)

 Williams, W.L.; Esposito, R.G.; Hernandez, H.G. (19??) To
 Determine the Effect of Intra-peritoneal Injection of Biotrol
 10W-fi"Bacillus thuringiensis~Berliner~followed by Serial Passage of
 Blood Intra-peritoneally through Four Consecutive Passages hi Mice:
 Experiment Nutrilite Products, Inc. #2 (504-5).  (Unpublished study
 received Jan 4, 1977 under 6296-13; submitted by Nutrilite Products,
 Inc., Buena Park, Calif.;  CDL:230811-C)    >

 Williams, W.L.; Esposito, H.G.; Hernandez, H.G. (19??) To
 Determine the Effect of Intra-peritoneal Injection of Lavatrol on
 Weight Gain and Mortality of Mice. (Unpublished study received Jun
 30, 1959 under PPOSlO; submitted by Nutrilite Products, Inc., Buena
 Park, Calif.; CDL:090329-B)

 Williams, W.L.; Esposito, R.G.; Hernandez, H.G. (19??) To
 Determine the Effect of Intra-peritoneal Injection of Larvatrol-Bacillus
 thuringiensis'Berliner—Followed by Serial Passage of Blood
 Intra-peritoneally through Four Consecutive Passages hi Mice.
 (Unpublished study received Jun 30, 1959 under PP0310; submitted by
 Nutrilite Products, Inc., Buena Park, Calif.; CDL:090329-C)

 Lankas, G.R.; Hogan, G.K.; Fasanella, J.; et al. (1981) A Single Oral
. Dose Toxicity/Infectivity Study of Thuricide 32 B hi Rats: Project No.
 80-2523; Export No. T-l-2/23/81.  (Unpublished  study received Mar
 8, 1982 under 11273-2; d by Bio/dynamics, Inc.,  submitted by Sandoz,
 Inc.-Crop Protection, San Diego,Calif.; CDL:246967-A)

 Ben-Dyke, R.; Hogan, G.K.; Hoffman, C.A.; et al. (1981) An Acute
 Inhalation Toxicity  and Infectivity Study of Thuricide 32-B hi the Rat:
 Project No. 80-7472; rt No.  T-3-3/16/81. (Unpubblished study
 received Mar 8, 1982 under  11273-2; prepared by Bio/dyanamics, Inc.,
 submitted by Sandoz,  Inc.—Crop Protection, San Diego, Calif.;
 CDL:246967-C)
                                            63

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   MRID
          BIBLIOGRAPHY
             CITATION
00096533
00109492
00109493
00142733
00142734
40497400
40497409
40497410
World Health Organization (1980) Data Sheet on the Biological Control
Agent'Bacillus thuringiensis" Serotype H-14 (de Barjac 1978):
WHO/VBC/79.750. (Unpublished study; CDL:246969-B)

Lankas, G.; McCormack, R.; Hogan, G.; et al. (1981) Single Oral
Dose Toxicity/Infectivity Study of Thuricide 32B in the Rat: Project
No. 80-2523; Report No. T-l-2/23/81.  Final rept. (Unpublished study
received Aug 9, 1982 under 11273-2; prepared in cooperation with
Bio/dynamics, Inc., submitted by Sandoz, Inc., Crop Protection, San
Diego, CA; CDL:248007-E)

Lankas, G.; McCormack, R.; Hogan, G.; et al. (1981) Acute Dermal
Toxicity/Infectivity Study of Thuricide 32B in the Rat: Project No.
80-2531; Report No. T-l-3/11/81. Final rept.  (Unpublished study
received Aug 4, 1982 under 11273-2; prepared in cooperation with
Bio/dynamics, Inc., submitted by Sandoz, Inc., Crop Protection, San
Diego, CA; CDL:248007-F)

 StoU, R. (1984) Acute Oral LD50 Toxicity/Infectivity Study of Teknar
in the Rat: Project No. T-1866. Unpublished study prepared by
Sandoz, Inc.  25 p.

Stoll, R. (1984) Acute Dermal LD50 Toxicity/Infectivity Study in the
Rat on Teknar: Project No. T-1867.  Unpublished study prepared by
Sandoz, Inc.  18 p.

Sandoz Crop Protection Corporation (1988) Submission of Chemistry,
Toxicity and Residue Data on SAN 418-SC-62 in Support of Trident
Biological Insecticide Registration.  Transmittal of 13 studies.

Beavers, J.; Jaber, M. (1987) SAN 418 SC 62 Bacillus Thuringiensis
Tenebrionis: An Avian Acute Oral LD50 Pathogenicity Study in the
Mallard": Study No. 131-132.  Unpublished study performed by
Wildlife International Ltd.  19 p.

Beavers, J.; Jaber, M. (1987) SAN 418 SC 62 Bacillus Thuringiensis
Tenebrionis: An Avian Intraperitoneal Injection Pathogenicity Study in
the Mallard: Study No. 131-133. Unpublished study performed by
Wildlife International Ltd.  19 p.
                                            64

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   MRID
         BIBLIOGRAPHY
             CITATION
40497411
40497412
40951100
41270301
41308600
41308603
41308607
41412705
Surprenant, D. (1987) Static Acute Toxicity of SAN 418 SC62 (B. t. .
tenebrionis) to Rainbow Trout (Salmo gairdneri): Report No.
87-10-2520.  Unpublished study performed by Springborn Life
Sciences, Inc.  18 p.

Surprenant, D. (1987) Static Acute Toxicity of SAN 418 SC62 (B. t.
tenebrionis) to Daphnids (Daphnia magna): Report No.87-10-2519.
Unpublished study performed by Springborn Life Sciences, Lie.  17 p.

Ecogen, Inc. (1988) Submission of Chemistry and Toxicity Data in
Support of Foil Oil Flowable Insecticide.  Transmittal of 10 studies.

Robbins, G.  (1989) Intraperitoneal Safety Test in Mice: BMP  144(2X)
(3X): Study No. S2032. Unpublished study prepared by Cosmopolitan
Safety Evaluation, Inc.  18 p.

Ecogen, Inc. (1989) Submission of data in support of registration of
Foil Oil Flowable Bioinsecticide: Toxicity studies.  Transmittal of 8
studies.

Sherwood, R. (1989) EPA Subdivision M  Tier I Acute Pulmonary
Toxicity/Pathogenicity Testing of Foil Oil Flowable and Technical
Biopesticides: Final Report: IIT Project Number L08245, Study No.  1.
Unpublished study prepared by IIT Institute, Life Sciences Research.
44 p.

Sherwood, R. (1989) Acute Intraperitoneal Toxicity/Pathogenicity
Testing of Foil Technical Powder, a Microbial Pesticide: Final Report:
HTRI Project Number L08239: Study No. 7.  Unpublished study
prepared by IIT Research Institute, Life Sciences Research.  19 p.

Berg, N. (1989) Acute Dermal Toxicity Study in Rabbits with SP 408,
PPQ 2585 in Support of Registration of Novodor Technical: Lab
Project I.D.: 13188. Unpublished study prepared by Novo-Nordisk
A/S, Enzyme Toxicology Laboratory.  16 p.
                                            65

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   MRID
         BIBLIOGRAPHY
             CITATION
41429701
41429702
41429703
41429704
41435401
41435402
41439001
41439002
Peter, S.; Boon, B.; Charmoille, L. (1990) Registration Standard No.
0247: Bacillus thuringiensis var. israelensis:  Bactomos Primary
Powder: Product Identity and Disclosure of Ingredients ...: Lab Project
Number: 56637/10/90: BT:RS.  Unpublished study prepared by Solvay
&Cie. 59 p.

Peter, J.- Boon, B.; Malcorps, C.  (1990) Registration Standard No.
0247: Bacillus thuringiensis var. israelensis:  Bactomos Primary
Powder: Description of Manufacturing Process ...: Lab Project
Number: BT:RS: 56637/16/90.  Unpublished study prepared by Solvay
&Cie. 89 p.

Peter, S.; Boon, B. (1990) Registration Standard No. 0247: Bacillus
thuringiensis var. israelensis: Bactomos Primary Powder: Product
Analysis Data ...: Lab Project Number: BT:RS: 56637/17/90.
Unpublished study prepared by Solvay & Cie. 16 p.

Peter, S.; Boon, B. (1990) Registration Standard No. 0247: Bacillus
thuringiensis var. israelensis: Bactomos Primary Powder: Physical and
Chemical Properties ...: Lab Project Number: BT:RS:  566/37/18/90.
Unpublished study prepared by Solvay & Cie. 5 p.

Coddens, M.; Cooper, R. (1990) Product Analysis: Product Chemistry
Based on Bacillus Thuringiensis, Subspecies  Kurstaki (ATCC-SD-1275
as the Active Ingredient: Lab Project Number: Abbott Lab-FMU-02.
Unpublished study prepared by Abbott Laboratories. 23 p.

Coddens, M. (1990) Dipel FMU: Product Chemistry Based on Bacillus
thuringiensis, subspecies Kurstakis (ATCC-SD-1275) as an Active
Ingredient: Lab Project Number: ABBOTT/LAB-FMU-02.
Unpublished study prepared by Abbott Laboratories. 92 p.

Smith, R.; Cooper, R. (1990) Vectobac Technical Powder... Product
Chemistry Based on Bacillus thuringiensis, Subspecies  Israelensis
Strain AM65-52 (ATCC-SD-1276) as the Active Ingredient: Lab
Project Nos. Abbott Lab-VTp-02:  910-8906.  Unpublished study
prepared by Abbott Laboratories.  174 p.

Coddens, M. (1990) Vectobac Technical Powder...Product Chemistry
Based on Bacillus thuringiensis, Subspecies Israelensis, Strain
                                           66

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   MRID
41439003
41439005
41439006
41439007
41439008
41439009
41439010
          BIBLIOGRAPHY
             CITATION
                          AM65-52 (ATCC-SD-1276) as the Active Ingredient: Lab Project Nos.
                          Abbott Lab-VTP-03; 910-8902. Unpublished study prepared by Abbott
                          Laboratories.  186 p.
David, R. (1990) Acute Oral Toxicity/Pathogenicity Study of Vectobac
Technical Material (Bacillus thuringiensis var. Israelensis) in Rats:
Final Report: Lab Study No. G-7264.222. Unpublished study prepared
by Microbiological Associates, Inc. 61 p.

Lattin, A.; Grimes, J.; Hoxter, K.;.et al. (1990) Vectobac Technical
Material (Bacillus thuringiensis var Israelensis): An Avian Oral
Toxicity and Pathogenicity Study in the Mallard: Project No. 161-115.
Unpublished study prepared by Wildlife International Ltd. 24 p.

Lattin, A.; Hoxter, K.; Smith, G. (1990) Vectobac Technical Material
(Bacillus thuringiensis var Israelensis): An Avian Oral Toxicity and
Pathogenicity Study hi the Bobwhite: Project No. 161-114.
Unpublished study prepared by Wildlife International Ltd. 29 p.

Christenserr, K. (1990) Vectobac Technical Material (Bacillus
thuringiensis var. Israelensis)—Infectivity and Pathogenicity to Bluegill
Sunfish (Lepomis macrochirus) during a 30-day Static Renewal Test:
Final Report: SLI Report 90-2-3228; SLI Study 2439.0889.6104.158.
Unpublished study prepared by Springborn Laboratories, Inc.  55 p.

Christensen, K. (1990) Vectobac Technical Material (Bacillus
thuringiensis var. Israelensis)~Infectivity and Pathogenicity to Rainbow
Trout (Oncorhynchus mykiss) during a 32-day Static Renewal Test:
Final 'Report: SLI Report 90-2-3242; SLI Study 2439.0889.103.157.
Unpublished study prepared by Springborn Laboratories, Inc.  55 p

Ward, T.; Boeri, R. (1990) Chronic Toxicity of Vectobac Technical
Material (Bacillus thuringiensis var. Israelensis) to the Daphnid,
Daphnia magna: Lab Study No.  9022-A; Method No. IPM-2.
Unpublished study prepared by EnviroSystems Div., Resource
Analysts, Inc.  46 p.

Chandler, G. (1990) Chronic Toxicity of Bacillus thuringiensis var.
Israelensis Technical Material to the Benthic Harpacticoid Copepod,
Amphiascus minutus under Static Conditions: Report No.
                                            67

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   MRID
41441501
41441502
41441503
41441504
41441505
41441506
41441507
          BIBLIOGRAPHY
             CITATION
                           USC-SPH-2-90: Abbott Lab-VTP-12. Unpublished study prepared by
                           Univ. of South Carolina, School of Public Health and the Belle W.
                           Baruch Insitute for Marine Biology and Coastal Research. 43 p.
Smith, R.; Regan, K. (1990) Biochemical and Morphological
Characteristics of Bacillus thuringiensis subsp. Aizawai Strain SA2
with a Discussion of Strain History Included: Final Report: Final
Report No.: 90/02/02B.  Unpublished study prepared by Sandoz Crop
Protection Corp. 63 p.

Smith, R.; Regan, K. (1990) Biochemical and Morphological
Characteristics of Bacillus thuringiensis subsp. Israelensis Strain SA3
with a Discussion of Strain History Included: Final Report: Final
Report No.: 90/02/02D.  Unpublished study prepared by Sandoz Crop
Protection Corp. 38 p.

Smith, R.; Regan, K. (1990) Biochemical and Morphological
Characteristics of Bacillus thuringiensis subsp. Israelensis Strain SA3A
with a Discussion of Strain History Included: Final Report: Final
Report No.: 90/02/02A.  Unpublished study prepared by Sandoz Crop
Protection Corp. 63 p.

Shindler, J. (1990) Single Intraperitoneal Administration of Bacillus
thuringiensis Strain SA-2 in Mice: SRI Project Number LSC-8491: SRI
Study No. 8491-MO2-89. Unpublished study prepared by SRI
International. 38 p.

Schindler, J. (1990) Single Intraperitoneal Administration of Bacillus
Thuringiensis Strain SA-3 in Mice: SRI Project Number LSC-8491:
SRI Study No. 8491-M03-89.  Unpublished study prepared SRI
International. 15 p.

Schindler, J. (1990) Single Intraperitoneal Administration of Bacillus
thuringiensis Strain SA-3A in Mice: SRI Project Number LSC-8491:
SRI Study No. 8491-M04-89.  Unpublished study prepared by SRI
International. 16 p.
                      '
Chen, C.; Macuga, R. (1990) Plasmid Profile of Bacillus thuringiensis
subsp. Aizawai, Strain SA2: Final Report: Final Report No.
90/02/03E. Unpublished study prepared by Sandoz Crop Protection
                                            68

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   MRID
BIBLIOGRAPHY
   CITATION
                          Corp.  40 p.

41441508                 Chen, C.; Macuga, R. (1990) Plasmid Profile of Bacillus thuringiensis
                          subsp. Israelensis, Strain SA3: Final Report: Final Report No.
                          90/02/03C.  Unpublished study prepared by Sandoz Crop Protection
                          Corp.  40 p.

41441509                 Chen, C.; Macuga, R. (1990) Plasmid Profile of Bacillus thuringiensis,
                          subsp. Israelensis, Strain SA3A: Final Report: Final Report
                          No.90/02/03D. Unpublished study prepared by Sandoz Crop
                          Protection Corp. 40 p.

41441510                 Chen, 'C.; Macuga, R. (1990) Flagella Antigen Serotyping of Bacillus
                          thuringiensis subsp. Aizawai, Strain SA2: Final Report: Final Report
                          No. 90/02/12E.  Unpublished study prepared by Sandoz Crop
                          Protection Corp. 23 p.

41441511                 Chen, C.; Macuga, R. (1990) Flagella Antigen Serotyping of Bacillus
                          thuringiensis subsp. Israelensis, Strain SA3: Final Report: Final Report
                          No. 90/02/12C.  Unpublished study prepared by Sandoz Crop
                          Protection Corp. 23 p.

41441512                 Chen, C.; Macuga, R. (1990) Flagella Antigen Serotyping of Bacillus
                          thuringiensis subsp. Israelensis, Strain SA3A: Final Report: Final '
                          Report No. 90/02/12D. Unpublished study prepared by Sandoz Crop
                          Protection Corp. 23 p.

41441513            "     Smith, R.; Regan, K. (1990) Antibiotic Sensitivity Patterns for
                          Bacillus thuringiensis subsp. Aizawai,  Strain SA2:  Final Report:
                          Final Report No. 89/12/12C. Unpublished study prepared by Sandoz
                          Crop Protection Corp. 28 p.

41441514                 Smith, R.; Regan, K. (1989) Antibiotic Sensitivity Patterns for
                          Bacillus thuringiensis subsp-. Israelensis Strain SA3: Final Report:
                          Final Report No. 89/12/12D. Unpublished study prepared by Sandoz
                          Crop Protection Corp. 38 p.

41441515                 Smith, R.; Regan, K. (1989) Antibiotic Sensitivity Patterns for
                          Bacillus thuringiensis subsp. Israelensis Strain SA3A: Final Report:
                          Final Report No. 89/12/12E. Unpublished study prepared by Sandoz

                                           69

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   MRID
BIBLIOGRAPHY
   CITATION
                          Crop Protection Corp.  38 p.

41441516                 Cerf, D. (1990) Susceptibility of Four Orders of Insects
                          (Lepidoptera, Diptera, Coleoptera, and Orthoptera) to Technical
                          Grade Active Ingredients (TGAI's), Manufacturing.  . . and
                          tenebrionis in SA10): Final Report: Final Report No. 90/03/12.
                          Unpublished study prepared by Sandoz Crop Protection Corp. 40 p.

41441517                 Chen, C.; Macuga, R. (1990) Description of Endotoxin Proteins
                          Produced by Bacillus thuringiensis subsp. Aizawai, Strain SA2: Final
                          Report: Final Report No. 90/02/21C. Unpublished study prepared
                          by Sandoz Crop Protection Corp.  30 p.

41441518                 Chen, C.; Macuga, R. (1990) Description of Endotoxin Proteins
                          Produced by Bacillus thuringiensis subsp. Israelensis, Strain SA3:
                          Final Report: Final Report No. 90/02/21E.  Unpublished study
                          prepared by Sandoz Crop Protection Corp.  27 p.

41441519                 Chen, C.; Macuga, R. (1990) Description of Endotoxin Proteins
                          Produced by Bacillus thuringiensis subsp. Israelensis, Strain SA3A:
                          Final Report: Final Report No. 90/02/21F.  Unpublished study
                          prepared by Sandoz Crop Protection Corp.  27 p.

41441520                 Chen, C.; Macuga, R.; Cerf, D. (1990) Insecticidal Toxins Produced
                          by Bacillus thuringiensis subsp. Aizawai, Strain SA2. I. Effect of
                          Autoclaving: Final Report: Final Report No. 90/01/3IE.
                          Unpublished study prepared by Sandoz Crop Protection Corp. 19 p.
                                                             {
41441521                 Chen, C.; Macuga, R.; Cerf, D. (1990) Insecticidal Toxins Produced
                          by Bacillus thuringiensis subsp. Israelensis, Strain SA3.1. Effect of
                          Autoclaving: Final Report: Final Report No. 90/01/31. Unpublished
                          study prepared by Sandoz Crop Protection Corp. 19 p.

41441522                 Chen, C.; Macuga, R.; Cerf, D. (1990) Insecticidal Toxins Produced
                          by Bacillus thuringiensis subsp. Israelensis, Strain SA3A. I. Effect of
                          Autoclaving: Final Report: Final Report No. 90/01/31D.
                          Unpublished study prepared by Sandoz Crop Protection Corp. 19 p.

41441523                 Chen, C.; Cerf, D.; Sjolander, A.; et al. (1990) Insecticidal Toxins
                          Produced by Bacillus thuringiensis subsp. Aizawai, Strain. II.

                                           70

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   MRID
          BIBLIOGRAPHY
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                          Concentration of beta-Exotoxin: Final Report: Final Report No.
                          90/02/07E.  Unpublished study prepared by Crop Protection Corp.
                          36 p.
41441524
41441525
41441526
41441527
41441528
41441529
41441530
41441531
Chen, C.; Cerf, D.; Sjolander, A.; et al. (1990) Insecticidal Toxins
Produced by Bacillus thuringiensis subsp. Israelensis, Strain SA3. II.
Concentration of beta-Exotoxin: Final Report: Final Report No.
90/02/07C.  Unpublished study prepared by Sandoz Crop Protection
Corp.  36 p.

Chen, C.; Cerf, D.; Sjolander, A.; et al. (1990) Insecticidal Toxins
Produced by Bacillus thuringiensis subsp. Israelensis, Strain SA3A.
II. Concentration of beta-Exotoxin: Final Report:  Final Report No.
90/02/07D.  Unpublished study prepared by Sandoz Crop Protection
Corp.  36 p.

Fowler, J. (1989) Physical Properties of SA-2 Technical Grade -
Active Ingredient: Final Report: Final Report No. 89/11/30E.
Unpublished study prepared by Sandoz Crop Protection Corp. 32 p.

Fowler, J. (1989) Physical Properties of SA-3 Technical Grade
Active Ingredient (TGAI): Final Report: Final Report No.
89/11/30A.  Unpublished study prepared by Sandoz Crop Protection
Corp. 32 p.

Fowler, D. (1989) Physical Properties of Certan:  Final Report: Final
Report No. 89/11/30D.  Unpublished study prepared by Sandoz Crop
Protection Corp. 32 p.

Fowler, J. (1989) Physical Properties of Teknar: Final  Report: Final
Report No. 89/11/30.  Unpublished study prepared by Sandoz Crop
Protection Corp. 32 p.

Fowler, J. (1989) Physical Properties of Teknar HPD:  Final Report:
Final Reppi* No. 89/11/30B. Unpublished study  prepared by Sandoz
Crop-Protection Ccrp. 32 p.

Fowler, J. (1989) Physical Properties of SA-3A Technical Grade
Active Ingredient (TGAI): Fi^al Report: Final Report No. '
89/11/30C.  Unpublished study prepared by Sandoz Crop Protection
                                           71

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   MRID
BIBLIOGRAPHY
   CITATION
                           Corp. 32 p.

41441601                  Smith, R.; Regan, K. (1990) Biochemical and Morphological
                           Characteristics of Bacillus thuringiensis subsp. kurstaki Strain SA12
                           with a Discussion of Strain History Included: Lab Project Number
                           90/02/02F.  Unpublished study prepared by Sandoz Crop Protection
                           Corp.  63 p.

41441602  '                Smith, R.; Regan, K. (1990) Biochemical and Morphological
                           Characteristics of Bacillus thuringiensis subsp. tenebrionis Strain SA
                           10 with a Discussion of Strain History Included: Final Report: Lab
                           Project Number: 90/02/02.  Unpublished study prepared by Sandoz
                           Crop Protection Corp.  63 p.

41441603                  Smith, R. ; Regan, K. (1990) Biochemical and Morphological
                           Characteristics of Bacillus thuringiensis subsp. kurstaki Strain
                           INT-15-313 with a Discussion of Strain History Included: Final
                           Report: Project Number: 90/02/02C. Unpublished study prepared by
                           Sandoz Crop Protection Corp.  63  p.

41441604                  Smith, R.; Regan, K. (1990) Biochemical and Morphological
                           Characteristics of Bacillus Thuringiensis Subsp. kurstaki Strain
                           SA11001C98-1-1 with a Discussion of Strain History Included: Final
                           Report: Project Number: 90/02/02E. Unpublished study prepared by
                           Sandoz Crop Protection Corp.  63  p.

41441605                  Chen, C.; Macuga, R.; Cerf, D. (1990) Insecticidal Toxins Produced
                           by Bacillus Thuringiensis Subsp. Tenebrionis Strain SA10.1. Effect
                           of Autoclaving: Final Report: Lab  Project Number: 90/01/3 IF.
                           Unpublished study prepared by Sandoz Crop Protection Corp. 19 p.

41441606                  Chen, C.; Macuga, R.; Cerf, D. (1990) Insecticidal Toxins Produced
                           by Bacillus thuringiensis subsp. kurstaki Strain SA11001C98-1-1.1.
                           Effect of Autoclaving: Final Report: Lab Project Number:
                           90/01/31 A. Unpublished study prepared by Sandoz Crop Protection
                           Corp.  19 p.

41441607                  Chen, C.; Macuga, R.; Cerf, D. (1990) Insecticidal Toxins Produced
                           by Bacillus thuringiensis subsp. kurastaki Strain INT-15-313. I.
                           Effect of Autoclaving: Final Report: Lab Project Number: 90/01/31.

                                           72

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   MRID
41441608
41441609
          BIBLIOGRAPHY
             CITATION
                          Unpublished study prepared by Sandoz Crop Protection Corp.  19 p.
Chen, C.; Macuga, R.; Cerf, D. (1990) Insecticidal Toxins Produced
by Bacillus thuringiensis subsp. kurstaki Strain SA12. I. Effect of
Autoclaving: Lab Project Number: 90/01/31B. Unpublished study
prepared by Sandoz Crop Protection Crop.  19 p.

Schindler, J. (1990) Single Intraperitoneal Administration of Bacillus
thuringiensis Strain SA-10 hi Mice: Lab Project Number:
8491-M05-89: LSC-8491. Unpublished study prepared by SRI
International,  15 p.
41441610
41441611
41441612
41441613
41441614
41441615
Schindler, J. (1990) Single Intraperitoneal Administration of Bacillus
thuringiensis Strain SA-12 in Mice: Lab Project Number:
8491-M07-89: LSC-8491. Unpublished study prepared by SRI
International.  17 p.

Schindler, J. (1990) Single Intraperitoneal Administration of Bacillus
thuringiensis Strain 313 hi Mice: Lab Project Number: 891-M01-89:
LSC-8491. Unpublished study prepared by SRI International.  15 p.

Schindler, J. (1990) Single Intraperitoneal Administration of Bacillus
thuringiensis Strain SA-11 in Mice: Lab Project Number:
8491-M06-89: LSC-8491. Unpublished study prepared by SRI
International.  15 p.

Chen, C.; Macuga, R. (1990) Plasmid Profile of Bacillus
thuringiensis subsp. tenebrionis Strain SA10: Lab Project No:
90/02/03F. Unpublished study prepared by Sandoz Crop Protection
Corp. 40 p.

Chen, C.; Macuga, R. (1990) Plasmid Profile of Bacillus
thuringiensis subsp. kurstaki Strain SA11001C98-1-1: Lab Project
Number: 90/0203A. Unpublished study prepared by Sandoz Crop
Protection Corp. 40 p.

Chen, C.; Macuga, R. (1990) Plasmid Profile of Bacillus
thuringiensis subsp. kurstaki Strain INT-15-313: Lab Project
Number: 90/02/03. Unpublished study prepared by Sandoz Crop
                                           73

-------
   MRID
BIBLIOGRAPHY
   CITATION
                          Protection Corp.  40 p.

41441616                 Chen, C.; Macuga, R. (1990) Plasmid Profile of Bacillus
                          thuringiensis subsp. kurstaki Strain SA12: Lab Project Number:
                          90/02/03B. Unpublished study prepared by Sandoz Crop Protection
                          Corp. 40 p.

41441617                 Chen, C.; Macuga, R. (1990) Flagella Antigen Serotyping of Bacillus
                          thuringiensis subsp. tenebrionis Strain SA10: Lab Project Number:
                          90/02/12F.  Unpublished study prepared by Sandoz Crop Protection
                          Corp. 23 p.

41441618                 Chen, C.; Macuga, R. (1990) Flagella Antigen Serotyping of Bacillus
                          thuringiensis subsp. kurstaki Strain SA11001C98-1-1: Lab Project
                          Number: 90/02/12A. Unpublished study prepared by Sandoz Crop
                          Protection Corp.  23 p.

41441619                 Chen, C.; Macuga, R. (1990) Flagella Antigen Serotyping of Bacillus
                          thuringiensis subsp. kurstaki Strain SA11001C98-1-1: Lab Project
                          Number: 90/02/12A. Unpublished study prepared by Sandoz Crop
                          Protection Corp.  23 p.
,1                .                       •
41441620                 Chen, C.; Macuga, R. (1990) Flagella Antigen Serotyping of Bacillus
                          thurrngiensis subsp. kurstaki Strain SA12: Lab Project Number:
                          90/02/12B. Unpublished study prepared by Sandoz Crop Protection
                          Corp. 23 p.

41441621                 Smith, R.; Regan, K. (1989) Antibiotic Sensitivity Patterns for
                          Bacillus thurrngiensis subsp. tenebrionis Strain SA10: Lab Project
                          Number: 89/12/12B. Unpublished study prepared by Sandoz Crop
                          Protection Corp.  28 p.

41441622                 Smith, R.; Regan, K. (1989) Antibiotic Sensitivity Patterns for
                          Bacillus thuringiensis subsp. kurstaki Strain SA11001C98-l-l:Lab
                          Project Number: 89/12/12.  Unpublished study prepared by Sandoz
                          Crop Protection Corp. 28 p.

41441623                 Smith, R.; Regan, K. (1989) Antibiotic Sensitivity Patterns for
                          Bacillus thuringiensis subsp. kurstaki Strain INT-15-313:  Lab Project
                          Number: 89/12/12A. Unpublished study prepared by Sandoz Crop

                                           74

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   MRID
BIBLIOGRAPHY
   CITATION
                          Protection Corp.  28 p.
                                                                   /
41441624                 Smith, R.; Regan, K. (1989) Antibiotic Sensitivity Patterns for
                          Bacillus thuringiensis subsp. kurstaki Strain SA12: Lab Project
                          Number: 89/12/12F. Unpublished study prepared by Sandoz Crop
                          Protection Corp.  28 p.

41441625                 Cerf, D. (1990) Susceptibility of Four Orders of Insects
                          (Lepidoptera, Diptera, Coleoptera, and Orthoptera to Technical
                          Grade Active Ingredients (TGAI'S), (. .,.) and tenebrionis (strain
                          SA10): Lab Project Number: 90/03/12.  Unpublished study prepared
                          by Sandoz Crop Protection Corp. 40 p.

41441626                 Chen, C.; Macuga, R. (1990) Description of Endotoxin Proteins
                          Produced by Bacillus thuringiensis subsp. kurstaki Strain
                          INT-15-313: Lab Project Number: 90/02/21A. Unpublished study
                          prepared by Sandoz Crop Protection Corp. J30 p.

41441627                 Chen, C.; Macuga, R. (1990) Description of Endotoxin Proteins
                          Produced by Bacillus thuringiensis subsp. kurstaki Strain -1-1: Lab
                          Project Number: 90/02/21. Unpublished study prepared by Sandoz
                          Crop Protection Corp.  30 p.

41441628                 Chen, C.; Macuga, R, (1990) Description of Endotoxin Proteins
                          Produced by Bacillus thuringiensis subsp. kurstaki Strain SA12:
                          Project Number: 900221B.  Unpublished study prepared by Sandoz
                          Crop Protection Corp.  30 p.

41441629      ^'         Chen, C.; Macuga, R. (1990) Description of Endotoxin Proteins
                          Produced by Bacillus thuringiensis subsp. tenebrionis Strain SA10:
                          Lab Project Number: 90/02/21D. Unpublished study prepared by
                          Sandoz Ciop Protection Corp.  25 p.

41441630                 Chen, C.; Cerf, D.; Sjolander, A.; et al. (1990) Insecticidal Toxins
      -   -              -   Produced by Bacillus thuringiensis subsp. kurstaki Strain
                          SA11001C98-1-1. H. Concentrated of Beta-exotoxin: Lab Project
                          Number: 90/02/07A. Unpublished study prepared by Sandoz Crop
                          Protection Corp.  36 p.

41441631                 Chen, C.; Cerf, D.; Sjolander, A.; et al. (1990) Insecticidal Toxins
                                           75

-------
   MRID
          BIBLIOGRAPHY
             CITATION
                          Produced by Bacillus thuringiensis subsp. kurstaki Strain
                          INT-15-313. E. Concentration of Beta-exotoxin: Lab Project
                          Number: 90/02/07.  Unpublished study prepared by Sandoz Crop
                          Protection Corp. 36 p.
41441632
41441633
41441634



41441635



41441636



41441637



41441638



41441639


41441640
Chen, C.; Cerf, D.; Sjolander, A.; et al. (1990) Insecticidal Toxins
Produced by Bacillus thuringiensis subsp. tenebrionis Strain SA10.
H. Concentration of Beta-exotoxin: Lab Project Number: 90/02/07F.
Unpublished study prepared by Sandoz Crop Protection. Corp. 36 p.

Chen, C.; Cerf, D.; Sjolander, A.; et al. (1990) Insecticidal Toxins
Produced by Bacillus thuringiensis subsp. kurstaki Strain SA12. II.
Concentration of Beta-exotoxin: Lab Project Number: 90/02/07B.
Unpublished study prepared by Sandoz Crop Protection Corp. 36 p.

Fowler, J. (1989) Physical Properties of 313 1. 5B Dust: Lab Project
Number: 89/11/30K. Unpublished study prepared by Sandoz Crop
Protection Corp. 29 p.

Fowler, J. (1989) Physical Properties of Trident II: Lab Project
Number: 89/11/30F. Unpublished study prepared by Sandoz Crop
Protection Corp. 32 p.

Fowler, J. (1989) Physical Properties of SA-11 Spray Dried
Technical Concentrate (SDTC): Lab  Project Number: 89/11/30M.
Unpublished study prepared by Sandoz Crop Protection Corp. 29 p.

Fowler, J. (1989) Physical Properties of 313 Spray Dried Technical
Concentrate (SDTC): Lab Project Number: 89/11/30J. Unpublished
study prepared by Sandoz Crop Protection Corp. 29 p.

Fowler, J. (1990) Physical Properties of Thuricide 64LV: Lab
Project Number: 89/11/301.  Unpublished study prepared by Sandoz
Crop Protection Corp.  32 p.

Fowler, J. (1989) Physical Properties of SA-10 Technical Grade
Active Ingredient (TGAI): Lab Project Number: 89/11/30G.  32 p.

Fowler, J. (1989) Physical Properties of SA-11 Technical
Concentrate 360: Final Report: Lab Project Number: 89/11/30L.
                                           76

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   MRID
41441641
41443401
41443402
41443403
41443404
41443405
41443406
          BIBLIOGRAPHY
             CITATION
                          Unpublished prepared by Sandoz Crop Protection Corp. 29 p.
Fowler, J. (1989) Physical Properties of SA-12 Technical Grade
Active Ingredient: Final Report: Lab Project Number: 89/11/30H.'
Unpublished study prepared by Sandoz Crop Protection Corp. 32 p.

David, R. (1990) Acute Oral Toxicity/Pathogenicity Study of Dipel
Technical Material (Bacillus thuringiensis var. kurstaki) in Rats: Lab
Project Number: G-7239.222. Unpublished study prepared by
Microbiological Associates Inc. 54 p.

David, R. (1990) Acute Pulmonary Toxicity/Pathogenicity Study of
Dipel Technical Material (Bacillus thuringiensis var. Kurstaki hi
Rats: Lab Project Number: G-7239. 001. Unpublished study
prepared by Microbiological Associates Inc. 66 p.

Lattin, A.; Hoxter, K.; Driscoll, C.; et al. (1990) Dipel Technical
Material (Bacillus thuringiensis var kurstaki): An Avian Oral
Toxicity and Pathogenicity Study in the Mallard: Lab Project No:
161-113. Unpublished study prepared by Wildlife International Ltd.
28 p.

Lattin, A.; Grimes, J.; Hoxter, K.; et al. (1990) Dipel Technical
Material (Bacillus thuringiensis var kurstaki): An Avian Oral
Toxicity and Pathogenicity Study hi the Bobwhite: Lab Project
Number: 161-112.  Unpublished study  prepared by Wildlife
Intertional Ltd.  25 p.

Christensen, K. (1990) Dipel Technical Material (Bacillus
thuringiensis var. kurstaki) Infectivity and Pathogenicity to Bluegill
Sunfish (Lepomis Macrochirus) during  a 32-day Static Renewal Test:
Lab Project Number: 2439. 0889. 6108. 158. Unpublished study
prepared by Springborn Laboratories, Inc. 53 p.

Christensen, K. (1990) Dipel Technical Material (Bacillus
thuringiensis var. kurstaki)-Infectivity and Pathogenicity to Rainbow
Trout (Oncorhynchus mykiss) during a  32-Day Static Renewal Test:
Lab Project Number: 2469.0889.6107.157; 90-2-3219.  Unpublished
study prepared by Springborn Laboratories, Inc.  57 p.
                                           77

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          BIBLIOGRAPHY
             CITATION
41443407
41443408
41443409
41443410
41443411
41459401
41459402
Young, B. (1990) 21-Day Prolonged Static Renewal Toxicity of
Dipel Technical to Daphnia magna: Lab Project Number: 38417.
Unpublished study prepared by Analytical Bio-chemistry
Laboratories, Inc. 123 p.

Chandler, G. (1990) Chronic Toxicity of Bacillus thuringiensis var.
kurstaki Technical Material to the Benthic Harpacticoid Copepod,
Amphiascus Minutus under Static Condition: Toxicity Test Report:
Lab Project Number: USC-SPH-1-90. Unpublished study prepared
by Univ., of South Carolina,  School of Public Health. 43 p.

Beevers,  M. (1990) Effects of Bacillus thuringiensis subp. kurstaki
on the Insect Egg Parasitoid,  Trichogramma pretiosum: Final Report:
Lab Project Number: CAR/103-90. Unpublished study prepared by
California Agricultural Research, Inc., 41 p.

Nelson, R. (1990) The Effect of  the Microbial Pest Control Agent
Bacillus thuringensis subsp. kurstaki on the Predatory mite
Metaseiulus occidentalis (Nesbit) and their Host Prey the Twospotted
Spider Mite Tetranychus urticae  (Koch): Lab Project No:90.020:
Protocol No. I-PSI-NTO-PM-90. Unpublished study prepared by
Plant Sciences, Inc.  39 p.

O'Leary, P.  (1990) Effect of Bacillus thuringiensis subsp. kurstaki on
the Common Green Lacewing, Chrysoperla carnea (Stephens): Lab
Project Number: LR90-406.  Unpublished study prepared by
PanAgricultural Laboratories. 41 p.

Jensen, B.; Rugh, S.; Overholt, J. (1990) Product Analysis Data:
Product Identity and Manufacturing Information in Support of
Reregistration of Biobit Wettable Powder: Lab Project Number: 90-
0120: 90-0090: 90-0101.  Unpublished study prepared by
Novo-Nordisk A/S & Novo Laboratories, Inc. 303 p.

Jensen, B.; Rugh, S.; Overholt, J. (1990) Product Analysis Data:
Product Identity and Manufacturing Information in Support of
Reregistration of Biobit Flowable Concentrate: Lab Project Number:
F-890043: HG/TONI/JMO: F-882320.  Unpublished study prepared
by Novo-Nordisk A/S and Novo  Laboratories, Inc.  305 p.
                                           78

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             CITATION
41459403
41487401
41490801
41490802
41490803
41503901
41503902
Jensen, B.; Rugh, S.; Overholt, J. (1990) Product Analysis Data:
Product Identity and Manufacturing Information in Support of
Re-registration of Skeetal Flowable Concentrate: Lab Project
Number:  90006: AF/265/1/GB: F-893084. Unpublished study
prepared by Novo-Nordisk A/S & Novo Laboratories, Inc.  224 p.

David, R. (1990) Acute Pulmonary Toxicity/Pathogenicity Study of
Vectobac Technical Material (Bacillus thuringiensis var. israelensis)
in Rats: Lab Project Number: G-7264.225. Unpublished study
prepared by Microbiological Associates Inc. 3 p.

Hargrove, J. (1990)  Manufacturing Process Description and
Discussion of the Formation of Unintentional Ingredients for the
Production of Certain Biological Insecticide: Lab Project Number:
011990-E.  Unpublished study prepared by Sandoz Crop Protection
Corp.  34 p.

Hargrove, J. (1990)  Manufacturing Process Description and
Discussion of the Formation of Unintentional Ingredients for the
Production of Teknar Biological Insecticide:  Lab Project Number:
011990-C.  Unpublished study prepared by Sandoz Crop Protection
Corp.  34 p. .                    .

Hargrove, J. (1990)  Manufacturing Process Description and
Discussion of Formation of the Formation of Unintentional
Ingredients for the Production of Teknar HPD: Lab Project Number:
011990-B. Unpublished study prepared  by Sandoz Crop Protection
Corp.  34 p.

Jensen, B.; Rugh, S.; Overholt, J. (1990) Product Chemistry Data:
Physical and Chemical Properties hi Support of Reregistration of
Biobit Wettable Powder. Unpublished study prepared by Novo
Nordisk A/S & Novo Laboratories, Inc. 7 p.

Jensen, B.; Rugh, S.; Overholt, J. (1990) Product Chemistry Data:
Physical and Chemical Properties in Support of Reregistration of
Biobit Flowable Concentrate. Unpublished study prepared by Novo
Nordisk A/S & Novo Laboratories. 8 p.
                                           79

-------
   MRID
          BIBLIOGRAPHY
             CITATION
41503903
41540401
41540402
41540801
41540802
41590302
41653901
Jensen, B.; Rugh, S.; Overholt, J. (1990) Product Chemistry Data:
Physical and Chemical Properties in Support of Reregistration of
Skeetal Flowable Concentrate. Unpublished study prepared by Novo
Nordisk A/S & Novo Laboratories, Inc. 8 p.

Christensen, K.  (1990) Vectobac Technical Material (Bacillus
thurigiensis var. israelensis)-Infectivity and Pathogenicity to Sheep
head Minnow (Cyprinodon variegatus) during a 30-Day Static ,
Renewal Test: Lab Project Number: Report No.90-4-3288; Study
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Christensen, K.  (1990) Vertobac Technical Material (Bacillus
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Christensen, K.  (1990) Dipel Technical Material (Bacillus
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57 p.

Christensen, K.  (1990) Dipel Technical Material (Bacillus
thuringiensis var. kurstaki)~Infectivity and Pathogenicity to Grass
Shrimp (Palaemonetes vulgaris) during a 30-day Static Renewal Test:
Lab Project Number:  90-5-3337: 2439.0889.6109.161. Unpublished
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Ferry, E. (1990) Intraperitoneal Injection Test with Vectobac
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Sorenson, E.; Rugh, S.; Overholt, J. (1990) Product Analysis: Biobit
Wettable Powder: Lab Project Number: NOVO/REBW/VOL3.
Unpublished study prepared by Novo Nordisk hi cooperation with
Novo Nordisk Bioindustrials, Inc. 37 p.
                                           80

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Sorensen, E.; Rugh, S.; Overholt, J. (1990) Product Analysis Data:
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Christensen, K. (1990) Bacillus thuringiensis var. kurstaki Infectivity
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                                          81

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                                           83

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Winter, P.; Hoxter, K.; Smith, G.  (1990) Bacillus thuringiensis Var.
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Hoxter, K.; Smith, G. (1991) Bacillus thuringiensis var. Israelensis:
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Isaacson, J. (1991) Analysis of Beta-exotoxin (thuringiensis) Content
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Bellantoni, D.; Grimstead, S.; Roberts, C.; et al. (1991) Delta BT: A
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                                           85

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                                            86

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41994316                 Christensen, K. (1991) CGA-237218: Chronic Toxicity to Daphnids
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41994317                 Christensen, K. (1991) CGA-237218: Infectivity and Pathogenicity to
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41994318                 Christensen, K. (1991) CGA-237218 Technical Material: Infectivity
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41994319                 Whiter, P. (1991) CGA-237218: A Dietary Pathogenicity and
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41994320                 Thompson, M. (1991) CGA-237218: A Dietary and Toxicity  Study
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                                           88

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                                           89

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                           Unpublished study prepared by Abbott Labs.  28 p.

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PUBLICATIONS

Crickmore N., D. R. Zeigler, J.Feitelson, E. Schnepf, B. Lambert, D.  Lereclus,  J. Baum & D.H.
Dean (1995) Revision of the Nomenclature for the Bacillus thuringiensis Pesticidal cry Genes. In:
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Crickmore N., D.R. Zeigler J.Feitelson, E. Schnep, D. Lereclus, J. Baum, J. Van Rie and D.H.
Dean (1997)  Bacillus thuringiensis delta-endotoxin nomenclature  WWW site:
http://epurdx.biols.susx.ac.uk/ Home/Neil_Crickmore/ Bt/ index.html

Damgaard, D.H. (1995), Diarrhoeal enterotoxin production by strains of Bacillus thuringiensis
isolated from commercial Bacillus thuringiensis-based insecticides.  FEMS Immuno. andMed.
Microbiol 12, 245-250.

Estmch.J.J., G.W. Warren, MA Mullins, G.J. Nye, J.A. Craig, & M.G. Koziel (1996) VipSA, a
novel Bacillus thuringiensis vegetative insecticidal protein with a wide spectrum of activities
against lepidopteran insects. Proc. Natl. Acad. Sci. USA 93 5389-5394.

Hofte H. & H.R. Whiteley (1989) Insecticidal Crystal Proteins of Bacillus thuringiensis. Microbiol
Revs 53 242-255.

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McClintock, J.T., C.R. Schaffer, J.L. Kough, & R.D. Sjoblad (1995) Relevant Taxonomic
Considerations for Regulation of Bacillus thuringiensis-Based Pesticides by the U.S. Environmental
Protection Agency. In T-Y Feng, et al. (eds.), "Bacilus thuringiensis Biotechnology and
Environmental Benefits.", Vol. I, 313-325.

McClintock, J.T., C.R. Schaffer, & R.D. Sjoblad (1994) Mammalian Toxicity of Bacillus
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Tompkins, G., R. Engler, M. Mendelsohn, & P. Hutton (1990) Historical Aspects of the
Quantification of the Active Ingredient Percentage for Bacillus thuringiensis Products. In L.A.
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thuringiensis.  9-13.
                                            91

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                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                    WASHINGTON, D.C.  20460
                                                                            OFFICE OF
                                                                       PREVENTION, PESTICIDES
                                                                       AND TOXIC SUBSTANCES
                                                                         1'iAR  3 !   1998
                       GENERIC AND PRODUCT SPECIFIC
                             DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:

   This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-in Chemical Status Sheet, to
submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section El 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 hi
                          this Notice and hi Attachment 3 (for both generic and product
                          specific data), the Requirements Status and Registrant's Response
                          Form, (see section ffl-B); or

   3.                     Why you believe EPA should not require your submission of data
                          in the manner specified by this Notice (see section DI-D).

   If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this" Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice hi 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


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Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this _
infonnation is authorized under the PaperworkNReduction 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                  -      Why You are Receiving this Notice
Section II                 -      Data Required by this Notice
Section ffl                 -     Compliance with Requirements of this Notice
Section IV                -      Consequences of Failure to Comply with this Notice
Section V                 -      Registrants' Obligation to Report Possible Unreasonable
                                 Adverse Effects
Section VT                -      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 -                     List of Registrants Receiving This Notice
    5 -                     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 mgredient(s). You have been sent this Notice because you have
product(s) containing the subject active ingredients.
SECTION H. DATA REQUIRED BY THIS NOTICE

H-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).
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Depending on the results of the studies required in this Notice, additional studies/testing may
be required.

n-B. SCHEDULE FOR SUBMISSION OF DATA

   You are required to submit the data or otherwise satisfy the data requirements specified in
the Requirements Status and Registrant's Response Forms (Attachment 3) within the"
timeframes provided.

n-C. TESTING PROTOCOL

   All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
been established.

   These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).

   Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001 L
Street,  N.W., Washington, D.C.  20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).

   All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160].

E-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.
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SECTION HI.  COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

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

HI-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.

m-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 hi Section m-D.

    Two forms apply to generic data requirements, one or both of which must be used hi
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.
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   a.                      Voluntary Cancellation -
                                                        i
   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 Fonn(s'). If you choose this
option, these are the only forms that you are required to complete.

   If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
                                                                           I
   "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 hi 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
   (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;
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    (ii). Every registrant who is the ultimate source of the active ingredient in your product
    subject to this DCI must be in compliance with the requirements of this Notice and must
    remain in compliance; and
                                                       «
    (iii).  You must have provided to EPA an accurate and current "Confidential Statement of
    Formula" for each of your products to which this Notice applies.

    To apply for the Generic Data Exemption you must submit a completed Data Call-in
Response Form. Attachment 2 and all supporting documentation. The Generic Data Exemption
is item, number 6a on the  Data Call-in Response Form. If you claim a generic data exemption
you are not required to complete the Requirements Status and Registrant's Response Form.
Generic Data Exemption cannot be selected as an option for responding to product specific data
requirements.

    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  IQ-C.l. of this Notice and comprise options 1 through 6
of item 9 in the instructions for the Requirements Status and Registrant's Response Form and
item 6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy the
generic data requirements),  you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement.  Your response must be on the
forms marked "GENERIC" in item number 3.

    e.                     Request for Generic Data Waivers.

    Waivers for generic data are discussed in Section IH-D.l. of this Notice and are covered by
options 8 and 9 of item 9  in the instructions for the Requirements Status and Registrant's
Response Form. If you choose one of these options, you must submit both forms as well as any
other information/data pertaining to the option chosen to address the data requirement.

    2. Product Specific Data Requirements

    The options for responding to this Notice for product specific data are: (a) voluntary

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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 hi Section ID-D.2.

   Two forms apply to the product specific data requirements one or both of which must be
used in responding to the Agency, depending  upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
for product specific data (contained hi 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  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 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.
                   v
   If you choose to voluntarily cancel your product, further sale and  distribution of your
product after the effective date of cancellation must be hi accordance with the Existing Stocks
provisions of this Notice  which are contained  hi Section IV-C.
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   b.                      Satisfying the Product Specific Data Requirements of this Notice.

   There are various options available to satisfy the product specific data requirements of this
Notice. These options are discussed in Section m-C.2. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status  and
Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product specific Data Call-in
Response Form. Note that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregistration Eligibility
Decision document.

   c.                      Request for Product Specific Data Waivers.

   Waivers for product specific data are discussed in Section ffi-D.2. of this Notice and are
covered by option 7 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose this option, you must submit the Data Call-in Response Form
and the Requirements Status and Registrant's Response Form as well as any other
information/data pertaining to the option chosen to address  the data requirement.  Your
response must be on the forms marked "PRODUCT SPECIFIC"  hi 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 in this Section. The options are:

   (1)                     I will generate and submit data within the specified timeframe
                           (Developing Data)
   (2)                     I have entered into an agreement with one or more registrants to
                           develop data jointly (Cost Sharing)
   (3)                     I have made offers to cost-share (Offers to Cost Share)
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   (4)                     I am submitting an existing study that has not been submitted
                           previously to the Agency by anyone (Submitting an Existing
                           Study)
   (5)                     I am submitting or citing data to upgrade a study classified by
                           EPA as partially acceptable and upgradeable (Upgrading a Study)
   (6)                     I am citing an existing study that EPA has classified as acceptable
                           or an existing study that has been submitted but not reviewed by
                           the Agency (Citing an Existing Study)

Option 1.  Developing Data

   If you choose to develop the required data it must be in confonnance with Agency
deadlines and with other Agency requirements as referenced herein and hi 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
hi confonnance with the requirements of PR Notice 86-5. In addition, certain studies require
Agency approval of test protocols hi 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 n-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 n-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.

   A progress report must be  submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share hi 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 tune frame for submission of a final report is more than 1  year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full description of any
problems encountered since the last progress report.
   The tune frames hi the Requirements Status and Registrant's Response Form are the tune
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).

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    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 extra-ordinary 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 wUl not be submitting the data yourself, you must provide the name of the registrant who
will be submitting the data. You must also provide EPA with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an agreement
and the other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms. Section
3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they may
resolve their differences through binding arbitration.
Option 3. Offer to  Share in the Cost of Data Development

    If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of mis 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
registrants) developing the data has refused to accept the offer. To qualify for this option, you
must submit documentation to the Agency proving mat 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

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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
tune 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.     ' .

   To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:

   a.      '                You must certify at the time that the existing study is submitted
                           that the raw data and specimens from the study are available for
                           audit and review and you must identify where they are available.
                           This must' be done in accordance with the requirements of the
                           Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
                           As stated in 40 CFR 160.3  'Raw data' means any laboratory
                           worksheets, records, memoranda, notes, or exact copies thereof,
                           that are the result of original observations and activities of a study
                           and are necessary for the reconstruction and evaluation of the
                           report of that study. In the event that exact transcripts of raw data
                           have been prepared (e.g., tapes which have been transcribed
                           verbatim, dated, and verified accurate by signature), the exact
                           copy or exact transcript may be substituted for the original source
                           as raw data. 'Raw data' may include photographs, microfilm or
                           microfiche  copies, computer printouts,-magnetic media, including
                           'dictated observations, and recorded data from automated

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                           instruments." The term "specimens", according to 40 CFR 160.3,
                           means "any material derived from a test system for examination
                           or analysis."

   b.                      Health and safety studies completed after May 1984 also must
                           also contain all GLP-required quality assurance and quality
                           control information, pursuant to the requirements of 40 CFR Part
                           160. Registrants also must certify at the time of submitting the
                           existing study that such GLP information is available for post
                           May 1984 studies by including an appropriate statement on or
                           attached to the study signed by an authorized official or
                           representative of the registrant.

   c.                      You must certify that each study fulfills the acceptance criteria (if
                           there are any applicable 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.

   If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency  on the protocol and must indicate, as part of your
certification, the manner in which all Agency  comments, concerns, or issues were addressed in
the final protocol and study.

   If you know of a study pertaining to  any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.

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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 hi Attachment 1. If you submit data to upgrade an existing study you must satisfy or
supply information to correct all deficiencies  hi 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 MRDD
number(s) of the study which you are attempting to upgrade and must be hi 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 ha Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally, your submission of data intended
to upgrade studies  must be accompanied by a certification that you comply with each of those
criteria, as well as a certification regarding protocol compliance with Agency requirements.

Option 6. Citing Existing Studies

   If you choose to cite a study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable, or it must be a study which has not yet
been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing'and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.

   If you are citing a study of which you are not the original data submitter,.you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
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   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)                     I will generate and submit data within the specified time-frame
                           (Developing Data)
   (2)                     I have entered into an agreement with one or more registrants to
                           develop data jointly (Cost Sharing)
   (3)                     I have made offers to cost-share (Offers to Cost Share)
   (4)                     I am submitting an existing study that has not been submitted
                           previously to the Agency by anyone (Submitting an Existing
                           Study)
   (5)                     I am submitting or citing data to upgrade a study  classified by
                           EPA as partially acceptable and upgradeable (Upgrading a Study)
   (6)                     I am citing an existing study that EPA has classified as acceptable
                           or an existing study that has been
                           submitted but not reviewed by the Agency (Citing an Existing
                           Study)

Option 1. Developing Data — The requirements for developing product specific data are the
same as those described for generic data (see Section ULC.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.

Option 3. Offer to Share in the Cost of Data Development —The same requirements for generic
data (Section m.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.
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Option 4. Submitting an Existing Study - The same requirements described for generic data
(see Section DI.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
HI.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 HI.C.l., Option 6) apply to this option for product specific data..

    Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and hi the generic data requirements
section (ffl. C. 1.), as. appropriate.
HI-D REQUESTS FOR DATA WAIVERS

    1.                      Generic Data

    There are two types of data waiver responses to this Notice. The first is a request for a low
volume/minor use waiver and the second is a waiver request based on your belief that the data
requirement(s) are not appropriate for your product.

    a.Low Volume/Minor Use Waiver

    Option 8 under item 9 on the Requirements Status and Registrant's Response Form. Section
3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of requiring data for low
volume, minor use pesticides. In implementing this provision, EPA considers low volume
pesticides to be only those active ingredients whose total production volume for all pesticide
registrants is  small. In determining whether to grant a low volume,  minor use waiver, the
Agency will consider the extent, pattern and volume of use, the economic incentive to conduct
the testing, the importance of the peslicide, 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 hi 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 hi writing.  ,

    To apply for a low  volume, minor use waiver, you must submit the following information,
as applicable to your product(s), as part of your 90-day response  to this Notice:

                                          107

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

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

    (v) A list of each data requirement for which you seek a waiver. Indicate the type of
waiver sought and the estimated cost to you (listed separately for each data requirement and
associated test) of conducting the testing  needed to fulfill each  of these data requirements.
                                                 i.
    (vi) A list of each data requirement for which you are not  seeking any waiver and the
estimated cost to you (listed separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data requirements.

    (vii)  For each of the next ten years, a year-by-year forecast of company sales (pounds and
dollars) of the active ingredient, direct production costs of product(s) containing the active
ingredient (following the parameters in item 2 above), indirect production costs of product(s)
containing the active ingredient (following the parameters in item 3  above), and costs of data
development pertaining to the active ingredient.

    (viii) A description of the importance and unique benefits of the active ingredient to users.
Discuss the  use patterns and the effectiveness of the active ingredient relative to registered
alternative chemicals and non-chemical control strategies. Focus on benefits unique to the
active ingredient, providing information that  is as quantitative as possible. If you do not have
quantitative data upon which to base your estimates, then present the reasoning  used to derive
your estimates. To assist the Agency in determining the degree of importance of the active
ingredient in terms of its benefits, you should provide information on any of the following
factors, as applicable to your product(s): (a) documentation of the usefulness of the active
ingredient in Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives, (c)
information on the breakdown of the active ingredient after use and on its persistence in the

                                           108

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environment, and (d) description of its usefulness against a pest(s) of public health
significance.                                                     r

   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 in writing. If the Agency determines that
the data requirements of this Notice are not appropriate to your'product(s), you will not be
required to supply the data pursuant to section 3(c)(2)(B), If EPA determines that the data are
required for vour productfs). you must choose a method of meeting the requirements of this
Notice within the time frame provided by this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.             -      ,

2. Product Specific Data

   If you request a waiver for product specific data because you believe it is inappropriate,
you must attach a complete justification for the request including technical reasons, data and
references to relevant EPA regulations, guidelines or policies. (Note: any supplemental data
must be submitted in the format required by PR Notice 86-5). This will be. the only opportunity
to state the reasons or provide information in support of your request. If the Agency approves
your waiver request, you will not be required to supply the data pursuant to section 3(c)(2)(B)
of FIFRA. If the Agency denies your waiver request, you must choose an option for meeting*
the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements Status
and Registrant's  Response Form. Product specific data requirements for product chemistry,
acute  toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in
question. Waiver requests  submitted without adequate supporting rationale will be denied and
the original due date will remain hi force.
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SECTION IV.             CONSEQUENCES OF FAILURE TO COMPLY WITH THIS
                           NOTICE
                                                                     t

IV-A                      NOTICE OF INTENT TO SUSPEND

   The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:

   1.                      Failure to respond as required by this Notice within 90 days of
                           your receipt of this Notice.

   2.                      Failure to submit on the required schedule an acceptable proposed
                           or final protocol when such is required to be submitted to the
                           Agency for review.

   3.                      Failure to submit on the required schedule an adequate progress
                           report on a study as required by this Notice.
                                      !
   4.                      Failure to submit on the required schedule acceptable data as
                           required by this Notice.

   5.                      Failure to take a required action or submit adequate information
                           pertaining to any option chosen to address the data requirements
                           (e.g., any required action or information pertaining to submission
                           or citation of existing studies or offers, arrangements,  or
                           arbitration on the sharing of costs or the formation of Task
                           Forces, failure to comply with the terms of an agreement or
                           arbitration concerning joint data development or failure to comply
                           with any terms of a data waiver).

   6.                      Failure to submit supportable certifications as to the conditions of
                           submitted studies, as required by  Section 1H-C of this Notice.

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

   8,                      Failure of the registrant to whom you have tendered an offer to
                           share hi the cost of developing data and provided proof of the
                           registrant's receipt of such offer or failure of a registrant on
                           whom you rely for a generic data exemption either to:

                           i. Inform EPA of intent to develop and submit the data required

                                          110

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                           by this Notice on a Data Call-in Response Form and a
                           Requirements Status and Registrant's Response Form.

                           ii.  Fulfill the commitment to develop and submit the data as
                           required by this Notice; or

                           iii.  Otherwise take appropriate steps to meet the requirements
                           stated in this Notice,
 •v
                           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 tune following the issuance of this Notice.

IV-B.                      BASIS FOR DETERMINATION THAT SUBMITTED STUDY
                           IS UNACCEPTABLE
                                                t
   The Agency may determine that a study (even if submitted within the required tune) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:

1) EPA requirements specified in the Data Call-In Notice or other documents incorporated by
reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies. Such requirements include, but are not limited to, those relating
to test material, test procedures, selection of species, number of animals, sex and distribution
of animals, dose and effect levels to be tested or attained, duration of test,  and, as applicable,
Good Laboratory Practices.

2) EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.

3) EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy  of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this Notice of contained in PR 86-5.
All studies must be submitted hi the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.

IV-C                      EXISTING STOCKS OF SUSPENDED OR CANCELLED
                           PRODUCTS

   EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent
with the purposes of the Act.

                                          Ill

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   The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your product(s)
which may be suspended for failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA that granting such permission would be consistent
with the Act. You also must explain why an "existing stocks" provision is necessary, including
a statement of the quantity of existing stocks and your estimate of the time required for their
sale, distribution, and use. Unless you meet this burden, the Agency will not consider any
request pertaining to the continued sale, distribution, or use of your existing stocks after
suspension.

   If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in mil compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due,  to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons  other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a-case-by-case basis.

   Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA will
consider granting an existing stocks provision.
SECTION V.              REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
                           UNREASONABLE ADVERSE EFFECTS
                  \

   Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source,  including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement continues
as long as the products are registered by the Agency.

                                          112

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SECTION VL             INQUIRIES AND RESPONSES TO THIS NOTICE
                         *                                                       *
                                                               ;
   If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-in Chemical Status Sheet.
                                       i            -    ""'~~    ~                 T

  " 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 textile 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 .ypurs,     ..  -'•-..         -
                                          st L. Andersen, Director
                                      'Biopesticides and Pollution Prevention Division
  Attachments
      The Attachments to this Notice are:

      1 -                  '   Data Call-fa Chemical Status Sheet
      2 -                     Generic Data Call-in and Product Specific Data Call-in Response
                             Forms with Instructions                        ~  -
      3-   ,                  Generic Data Call-In and Product Specific Data Call-in
                             Requirements Status and Registrant's Response Forms with
                             Instructions
      4 -    '                 List of Registrants Receiving This Notice
      5 -                     Confidential Statement of Formula. Cost Share and Data
                             Compensation Forms
                                           113

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                114

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Attachment 1 Data Call-in Chemical Status Sheet
                     115

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Page Intentionally Blank
              116

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0247 DATA CALL-IN CHEMICAL STATUS SHEET     .                        .   -

INTRODUCTION

    You have been sent this Data Call-In Notice because you have product(s) containing 0247

    This Data Call-In Chemical Status Sheet contains an overview of dalla required by this notice, and point
of contact for inquiries pertaining to the reregistration of 0247.  For the Genetic Data Call-In, this
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice,, (2) the  Generic Data Call-
in Response Form, (3) the Requirements Status and Registrant's Form, (4) a list of registrants receiving this
DCI, and (5) the Cost Share and Data Compensation Forms in replying to this 0247 Generic Data Call-in.
For the Product Specific Data Call-In, 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, (4)  a list of registrants receiving this DCI, and (5) the Cost
Share and Data Compensation Forms in replying to this 0247 Product Specific Data Call-In.  Instructions
and guidance accompany each form.

DATA 'REQUIRED BY THIS NOTICE
                         >,
    The additional data requirements needed to complete the database for 0247 are contained in the
Requirements Status and Registrant's Response.  The Agency has concluded that additional data on 0247
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 0247 products.

INQUIRIES AND RESPONSES TO THIS NOTICE

    If you have any questions regarding the generic or product specific data requirements and procedures
established by this Notice, please contact William R. Schneider at (703) 308-8683.

All responses to this Notice for the Generic or the Product Specific data requirements should be submitted
to:
                            William R. Schneider, Ph.D.
                            Microbial and Plant Pesticide Branch
                            Biopesticides and Pollution Prevention Division (7511W)
                            Office of Pesticide Programs
                            U.S. Environmental Protection Agency
                            401 M St S.W.
                            Washington, D.C. 20460   ,
    RE: 0247
                                               117

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              118

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                 Attachment 2.
Combined Generic and Product Specific Data Call-In
 Response Forms (Form A inserts) Plus Instructions
                       119

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Page Intentionally Blank
               120

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DRAFT  COPY
Page  1 of  1
United States. Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE

INSTRUCTIONS- Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) if necessary. , \
1. Company name and Address 2. Case (f and Name
SAMPLE COMPANY ,. 0247 BT
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product'
Registration
•
5. I wish to
cancel this
product regis-
tration volun-
tarily.
•
8. Certification
I certify that the statements made on ti
I acknowledge that any knowingly false c
or both under applicable law.
Signature and Title of Company's Authors
6. Generic Data r
6a. I am claimlmg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
-
6b. I agree to satisfy Generic
Data requirements as indicated
on the atcachea torm entitled ,
"Requirements Status and
Regis trant ' s Response . "
i
•~, *
lis form and all attachments are true, accurate, and complete.
r misleading statement may be punishable by fine, imprisonment
zed Representative

7. Product Specific
Form Approved
OMB No. 2070-0107 '
2070-0057
Approval Expires 03-3X-96
on this form.
3; Date and Type of DCI
{GENERIC
i
Data ,
7a. My product is a MUP and
I agree to satisfy' the MUP
, requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
-

10. Name of Company Contact
/
7b My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
-
9. Date
11.
Phone Number
<
>

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              122

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DRAFT  COPY
Page  1 of  1
1 — »
K)
UJ
-United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE

INSTRUCTIONS Please type or print in ink Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) if necessary.
1 Company name and Address 2 Case ff and Name
SAMPLE COMPANY ' 0247 BT
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
NNNNNN-NNNNN
5 I wish to
cancel this
product regis-
tration volun-
tarily
-
8 Certification
I certify that the statements made on th
I acknowledge that any knowingly false c
or both under applicable law
Signature and Title of Company's Authori
6 Generic Data
6a I am claj.mimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below
N.A.
6b I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant ' s Response . "
N.A.
is form and all attachments are true, accurate, and complete.
r misleading statement may be punishable by fine, imprisonment
zed Representative

7 Product Specific
Form Approved
OMB No 2070-0107
2070-0057
Approval Expires 03'31-96
on this form
3 Date and Type of DCI
PRODUCT SPECIFIC
Data
7a My product is a MUP and
I agree to satisfy the MUP
requirements on the ^attached
form entitled "Requirements
Status and Registrant's
Response "


10 Name of Company Contact
-
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response "

9 Date
11
Phone Number
t ^

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           124

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    INSTRUCTIONS FOR COMPLETING THE "D.ATA 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 Reregistration
Program under the Federal Insecticide, Fungicide, and Rodenticide Act.  If you are an end-use product
registrant only and have been sent this DCI letter as part of a RED document you have been sent just the
product specific "Data Call-In Response Forms." 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 3 have been preprinted on the form. Item 4 has been preprinted on the product specific
form but must be filled in by the registrant on the generic form. Items 5 through 7 must be completed by the
registrant as appropriate. Items 8 through 11 must be completed by the registrant before submitting a response
to the Agency.

    The public reporting burden for this collection of information is estimated to average 15 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and maintaining
the data needed, and completing and reyiewing 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.

INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS

Generic and Product Specific Data Call-In

Item 1.                      ON BOTH FORMS:  This item identifies your company name, number and
                            address.

Item 2.                      ON BOTH FORMS:  This item identifies the case number, case name, EPA
                            chemical number and chemical name.

Item 3.                      ON BOTH FORMS:  This item identifies the type of Data Call-In. The date
                            of issuance is date stamped.                            '

Item 4.                      ON BOTH FORMS:  This item identifies the EPA product registrations
                            relevant to the data call-in. Please note that you are also responsible for
                            informing the Agency of your response regarding any product that you .

                                               125

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                             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. The number will be preprinted on the product specific form. On the
                             generic form, you must list all technical grade active ingredient and
                             manufacturing use registrations.

Item 5.                       ON BOTH FORMS: Check this item for each product registration you wish
                             to cancel voluntarily. If a registration number is listed for a product for which
                             you previously requested voluntary cancellation, indicate in Item 5 the date of
                             that request. Since this Data Call-In requires both generic and product
                             specific data, you must complete item 5 on both Data Call-In response forms.
                             You do not need to complete any item on the Requirements Status and
                             Registrant's Response Forms.

Item 6a.                      ON THE GENERIC DATA FORM: Check this Item if the Data Call-in is
                             for generic data as indicated in Item 3 and you are eligible for a Generic Data
                             Exemption for the chemical listed in Item 2 and used in the subject product.
                             By electing this exemption, you agree to the terms and conditions of a
                             Generic Data Exemption as explained in the Data Call-in Notice.

                             If you are eligible for or claim a Generic Data Exemption, enter the EPA
                             registration Number of each registered source of that active ingredient that
                             you use in your product.

                             Typically, if you purchase an EPA-registered product from one or more other
                             producers (who, with respect to the incorporated product, are in compliance
                             with this and any other outstanding Data Call-In Notice), and incorporate that
                             product into all your products, you may complete this  item for all products
                             listed on this form~If, however, you produce the active ingredient yourself, or
                             use any unregistered product (regardless of the fact that some of your sources
                             are registered), you may not claim a Generic Data Exemption and you may
                             not select this item.

Item6b.                      ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is
                             for generic data as indicated in Item 3 and if you are agreeing to satisfy the
                             generic data requirements of this Data Call-In. Attach the Requirements
                             Status and Registrant's Response Form that indicates how you will satisfy
                             those requirements.

                             NOTE: Item 6a and 6b are not applicable for Product Specific Data.

Item 7a.                      ON THE PRODUCT SPECIFIC DATA FORM:  For each manufacturing
                             use product (MUP) for which you wish to maintain registration, you must
                             agree to satisfy the data requirements by responding "yes."

Item 7b.                      For each end use product (EUP) for which you wish to maintain registration,
                             you must agree to satisfy the data requirements by responding rtyes."


                                                126

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                               FOR BOTH MUP and EUP products

                               You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if
                               your product is identical to another product and you qualify for a data
                               exemption.  You must provide the EPA registration numbers of your
                               source(s); do not complete the Requirements Status and Registrant's Response
                               form.  Examples of such products include repackaged products and Special
                               Local Needs (Section 24c) products which are identical to federally registered
                               products.

                               If you are requesting a data waiver, answer "yes" here; in addition, on the
                               "Requirements Status and Registrant's Response" form under Item 9, you
                               must respond with option 7 (Waiver Request) for each study for which you
                               are requesting a waiver.

                               NOTE:  Item 7a and 7b are not applicable for Generic Data.

Item 8.                         ON BOTH FORMS: This certification statement must be signed by an
                               authorized representative of your company and the person signing must
                               include his/her title.  Additional pages used in your response must be
                               initialled and dated in the space provided for the certification.

Item 9.                         ON BOTH FORMS: Enter the date of signature.

Item 10.                       ON BOTH FORMS: Enter the name of the person EPA should contact with
                               questions regarding your response.

Item 11.                       ON BOTH FORMS: Enter the phone number of your company contact.
   Note     You may provide additional information that does not fit on tins foim in a signed letter that accompanies your response For example, you may wish to
           report that your product has already been transferred to another company or that you have already voluntarily cancelled this product For these cases,
           please supply all relevant details so that EPA can ensure that its records are correct.
                                                   127

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                128

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                 Attachments.

Generic and Product Specific Requirement Status and
 Registrant's Response Forms (Form B inserts) and
                   Instructions
                       129

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              130

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t-age  x
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE '


Form Approved
OMB No; 2070-0107
2070-0057
Approval Expires 03-31-99
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply, the information requested on this form.
Use additional sheet (s) if necessary ' ,
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number -
•151A-11 *
•
5. Study Title
Manufacturing process
•
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2. Case # and Name
0247 BT
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Progress
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6. Use
Pattern
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7. Test
Substance

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10. Certification
I certify that the stat
I acknowledge that any
or both under applicabl
Signature and Title of
ements made on this form arid all attachments are true, accurate, and complete.
uiowingly false or misleading statement may be punishable by fine, imprisonment
e law.
Company's Authorized Representative

•
12. Name of Company Contact
3. Date and Type of DCI
GENERIC


8 .; Time
Frame
12

mos.
s
9. Registrant
Response

',
11. Date

-
13. Phone Number

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Page Intentionally Blank
             132

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                                                                                             Page  1 of  2
                               United States Environmental Protection Agency
                                           Washington, B.C. 20460
                                                                !
                                  * COMMENTS FOR GUIDELINE REQUIREMENTS
    Case # and Name
    0247  BT
    Chemical ft and Name
    GUIDELINE    COMMENT
    151A-11   The Manufacturing process must include both quality control testing for each production
              batch and a standarized,  specific,  detailed description of the process as tested to
              minimize or eliminate the heat labile exotoxins.

              (1)   Quality Control  Procedures:  A new manufacturing process must be submitted that
              includes a description of the qualitity control procedures as follows: QUALITY CONTROL
              TESTING REQUIRED FOR  EACH PRODUCTION BATCH: (a)  Bacillus thuringiensis shall be produced
              by pure culture, fermentation procedures with .adequate control measures during production
w             to detect any changes from the characteristics of' t;he parent- strain or contamination by
w             other microorganisms,  (b)  Each production batch,  prior to the addition of other
              materials,  shall be tested by subcutaneous injection'of at least .1 million spores, or
              equivalent for asporogenic strains,  into each  of five laboratory test mice weighing 17
              grams to 23 grams.  Such test shall show no evidence'of infection or injury in the test
              animals when observed for 7 days  following injection. ("Evidence of infection or injury-"
              is 'any indication of  either'systemic or .localized infection or'toxicity)  (c.) Production
            '  batches shall be.free of the Bacillus thuringiensis beta-exotoxin when tested*with the*
              fly larvae toxicity test ("Microbial Control of Insects and Mites." R>P>M> Bond, et al.,
              p.280ff.,  1971).  This specification can be satisfied either by determining that each
              master seed lot brought Into production is a .Bacillus thuringiensis strain which does
              not produce beta-exotoxin under standard manufacturing conditions or by periodically
              determining that beta-exotoxin syhnthesized during the manufacturing process is
              eliminated by the subsequent manufacturing process procedures(s).  (If the organism is
              capable of producing  beta-exotoxin,  the registrant should ensure that none is prese.nt in
              the TGAI and that the product is  not put in a  medium,- including formulated .end use'
              products that allow germination' and/or growth  at any time prior to use.)  Some
              registrants have been authorized  to use an HPLC method instead of the fly larvae test.
              In order to reconfirm the accuracy  of Agency records, those registrants must resubmit,
              or cite,  their request to use HPLC  and the supporting data to show that the method is at
              least as sensitive as the fly larvae test.

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                                                                                         Page 2 of 2
                           United States Environmental  Protection Agency
                                       Washington, B.C. 20460

                              * COMMENTS FOR GUIDELINE REQUIREMENTS .
Case ff and Name
0247  BT
Chemical (f and Name
GUIDELINE    COMMENT
          (2)  Standarization  of  the  Manufacturing Process,   The description of the manufacturing
         process must  also  include the fermentation medium composition'and the growth condition's.
         The process must be  designed to prevent production of significant amounts of the  heat
         labile exotoxins.    A sample from a production batch, using this exact process must  be
         tested by a Daphnia  study incorporating a 10 day exposure period using a maximum  hazard
         dose.  If the Daphnia test  shows significant lethality, a dose response Daphnia test
         must be performed  to derive an LC50.   If different media are to be used, a separate
         manufacturing process (and  testing)  must be submitted for each.

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DRAFT  COPY
Page  1 of
United States Environmental Protection Agency
Washington, D. C. 20460

REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
•





Form Approved

OMB No 2070-0107
2070-0057
Approval Expires 03 31 96
INSTRUCTIONS Please type or print in ink Please read carefully the attached instructions and supply the information requested on this form
Dse additional sheet (s) if necessary
1. Company name and Address 2 Case (f and Name
SAMPLE COMPANY 0247 BT
NO STREET ADDRESS
NO CITY, XX 000 00 > EPA Reg. No. NNNNNN-NNNNN

4. Guideline
Requirement
Number



151A-16(g)

81-1
81-2 .

81-3
81-4
81-5


t


B Study Title

^


Prod Chem - Microbxal
Storage stability (50)
Acute Toxic - Reqular Chemical
Acute oral toxicity-rat (1,37)
AOUte dermal (1,2,37)
toxicity-rabbit/rat
Acute inhalation toxictty-rat (3}
Primary eye irritation-rabbit (2)
Primary dermal xmtation. (1)2)

Efficacy -, Invertebrate. Control. Agents
Mosouito, Blackfly. Bitj.nqr.Hj.acre
Treatments
y
R
0
T
0
C
0
L














Progress
Reports

1


-












2















3





-









6. Use
Pattern




ABCDEFGHIJKLMNO

ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO

ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO





-
3 Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN


7 Test
Substance








MP/EP


MP/EP
MP/EP.


MP/EP -
MP/EP
MP/EP '




10. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law
Signature and Title of Company's Authorized Representative

12 Name of Company Contact ,
i
'



8. Time
Frame
• ,


'
15 mos .

8 mos.
8 mos.

8 mos.
8 mos,.
8 mos.

' »



9 Registrant
Response






.









11 Date
1

-


13. Phone Number

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         DRAFT  COPY
                                                                                                Page   2 of   2
                        United  States  Environmental  Protection Agency
                                        Washington,  D. C.  20460
                        REQUIREMENTS STATUS AND  REGISTRANT'S RESPONSE
                                                                                             Form Approved

                                                                                             OMB No. 2070-0107
                                                                                                   2070-0057
                                                                                             Approval Expires 03-31-96
INSTRUCTIONS: Please type or print in ink.  Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s)  i£ necessary.
1. Company name and Address
   SAMPLE  COMPANY
   NO  STREET ADDRESS
   NO  CITY,   XX   00000
                                 2. Case If and Name
                                   0247   BT

                                   EPA Reg. No.  NNNNNN-NNNNN
                                       3 Date and Type of DCI
                                         PRODUCT SPECIFIC
                                         ID#  NNNNNN-RD-NNNN
4 Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
95-10
                      Laboratory efficacy
                       evaluation
                         (1,3,4)
                                                     A  CDE
                     JK
                    EP
                    8  mos.
Initial to indicate certification as to information on this page
(full text of certification is on page one)
                                                                                    Date

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           DRAFTCOPY                   ,                                                                                   Page    1  o£\   1
                                           United  States  Environmental  Protection Agency
                                                            Washington,   D.   C.  20460
                                  FOOTNOTES AND  KEY DEFINITIONS  FOR  GUIDELINE REQUIREMENTS
                                                          Case # and  Name:  0247    BT
Key MP = manufacturing-use product, EP = end-use product; provided formulators  purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE. If a product is a  100 percent repackage of another registered product, registrants are not subject to any data requirement;
identified in the tables  ]; TEP = typical end-use product;TGAI = technical grade of the active ingredient, PAI = "pure" active ingredient; PAIRA = "pure" active
ingredient, radiolabeled
Dse Categories Key
  A - Terrestrial food crop        B - Terrestrial food feed crop     C - Terrestrial nonfood crop    D  - Aquatic food crop           E - Aquatic nonfood outdoor
  F - Aquatic nonfood Industrial   G - Aquatic nonfood residential   H   Greenhouse food crop        I  - Greenhouse nonfood crop      J - Forestry
  K   Residential outdoor"         L - Indoor food                   M - Indoor nonfood              N   Indoor Medical              0 - Indoor residential,

FOOtnOteS:  (The following notes are referenced in column two  (5  Study Title) of the REQUIREMENTS  STATUS AND REGISTRANT'S RESPONSE form ]


Prod Chera - Microbial

50  A storage stability study determining concentrations of beta-exotoxin must be determined in each EP immediately prior to packaging and 6 months later (unless a
    sooner or later interval can be demonstrated to be a more typical storage period)   The fly larva bioassay as well as a specific confirmatory method, such as HPLC,
    must both be used for analysis   This study is required only for all aqueous products that can support gram positive bacterial growth


Acute Toxic - Regular Chemical

 1  Not required if test  material is a gas or highly volatile     '             '
 2  Not required if test  material is corrosive to skin or has pH less than 2 or  greater than 11 5,  such a product will be classified as Toxicity Category I on the basis
    of potential eye and  dermal irritation effects.
 3  Required if the product consists of,  or under conditions of use will result  in, an inhalable material (e  g., gas, volatile substances,  or aerosol/particulate),
37  Testing of the EP dilution in addition to the EP or MP is required if it can be reasonably anticipated that the results' of such testing may meet the criteria for
    restriction to use by certified applicators specified in 40 CFR 152.170 (b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).

                                                 !
Efficacy - Invertebrate Control Agents

 1  The agency has waived all requirements to submit efficacy data for invertebrate control agents for nonpublic health uses   However, each registrant must ensure
    through testing that  his products are efficacious when used in accordance with label directions and commenly accepted pest control practices   The registrant must
    develop and maintain  the relevant data upon which the determination of efficacy is based   The Agency reserves the right to require, on a case by-case ba^is (e g.,
    significant'new uses  or benefits data in cases of special reviews) submission of efficacy data for any pesticide product,  registered or proposed for registration
    when necessary
 3  Efficacy evaluations  can be conducted'under laboratory, greenhouse, or field conditions           >
 4  Required to be developed and maintained in the Registrant's file for all pests claimed on the label  when resistance to the pestcide has been demonstrated

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           138

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3. INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND REGISTRANT'S
   RESPONSE FORMS" FOR THE GENERIC AND PRODUCT SPECIFIC DATA CALL-IN
INTRODUCTION

   These instructions apply to the Generic and Product Specific "Requirements Status and Registrant's
Response Forms" and are to be used by registrants to respond to generic and product specific Data Call-in's
as part of EPA's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act.  If
you are an end-use product registrant only and have been sent this DCI letter as part of a RED document
you have been sent just the product specific "Requirements Status and Registrant's Response Forms." Only
registrants responsible for  generic data have been sent the generic data response forms. The type of Data
Call-in (generic or product specific) is indicated in item number 3 ("Date and Type of DCI") on each
form.

   Although the form is the same for both product specific and generic data, instructions for completing the
forms differ slightly. Specifically, options for satisfying product specific data requirements do not incltfde
(1) deletion of uses or (2) request for a low volume/minor use waiver. Please read these instructions
carefully before filling out the forms.

   EPA has developed these forms individually for each registrant, and has preprinted these forms to
include certain information unique to this chemical, DO NOT use these forms for any other active
ingredient.

   Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the registrant as
appropriate.  Items 10 through 13 must be completed by the registrant before submitting a response to the
Agency.

   The public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send comments
regarding the burden estimate or any other aspect of this collection of information, including suggestions for
reducing this burden, to Chief, Information Policy Branch, Mail Code 2136, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, D.C. 20460; and to the  Office of Management and Budget,
Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
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.
                                              139

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                             ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
                             case number, case name, and the EPA Registration Number of the product
                             for which the Agency is requesting product specific data.

Item 3.                       ON THE GENERIC DATA FORM: This item identifies the type of Data
                             Call-In.  The date of issuance is date stamped.

                             ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
                             type of Data Call-in. The date of issuance is also date stamped.  Note the
                             unique identifier number (ID#) assigned by the Agency.  This ID number
                             must be used in the transmittal  document for any data submissions  in
                             response to this Data Call-in Notice.

Item 4.                       ON BOTH FORMS: This item identifies the guideline reference number of
                             studies required.  These guidelines, in addition to the requirements specified
                             in the  Data Call-In Notice, govern the conduct of the required studies. Note
                             that series  61 and 62 in product chemistry are now listed under 40  CFR
                             158.155 through 158.180, Subpart c.

Item 5.                       ON BOTH FORMS: This item identifies the study title associated with the
                             guideline reference number and whether protocols and 1, 2, or 3-year
                             progress reports are required to be submitted in ^connection with the study.
                             As noted in Section III of the Data Call-In Notice, 90-day progress reports
                             are required for all studies.

                             If an asterisk appears in Item 5, EPA  has attached information relevant to
                             this guideline reference number to the Requirements Status and-Registrant's
                             Response Form.

Item 6.                       ON BOTH FORMS: This item identifies the code associated with the use
                             pattern of the pesticide.  In the case of efficacy data (product specific
                             requirement), the required study only pertains to products which have the
                             use sites and/or pests indicated. A brief description of each code follows:


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

                                               140

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Item 7.
Item 8.
           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:
                                                     v
        EUP                      End-Use Product
         MP                      Manufacturing-Use Product
   MP/TGAI  •            Manufacturing-Use Product and Technical Grade Active
                          Ingredient
         PAI                      Pure Active Ingredient
      PAI/M              Pure Active Ingredient and Metabolites
  PAI/PAIRA              Pure Active Indredient or Pute Active          Ingredient
                          Radiolabelled
      PAIRA              Pure Active Ingredient Radiolabelled
   PAIRA/M              Pure Active Ingredient Radiolabelled and Metabolites
  PAERA/PM              Pure Active Ingredient Radiolabelled and Plant Metabolites
        TEP                      Typical End-Use Product
   TEP	%              Typical End-Use Product, Percent Active Ingredient
                          Specified .
   TEP/MET              Typical End-Use Product and Metabolites
  TEP/PAI/M              Typical End-Use Product or Pure Active Ingredient and
                          Metabolites
       TGAI                      Technical Grade Active Ingredient
   TGAI/PAI              Technical Grade Active Ingredient or Pure Active Ingredient
TGAI/PAIRA       Technical Grade Active Ingredient or Pure Active Ingredient
                   Radiolabelled
   TGAI/TEP              Technical Grade Active Ingredient or Typical End-Use
                          Product
       MET                      Metabolites
        IMP                      Impurities
      DEGR              Degradates
            *                     See: guideline comment

            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.
                                              141

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Item 9.                        ON BOTH FORMS:  Enter the appropriate Response Code "or Codes to
                              show how you intend to comply with each data requirement. Brief
                              descriptions of each code follow. The Data Call-In Notice contains a fuller
                              description of each of these options.

    Option 1.                  ON BOTH FORMS:  (Developing Data) I will conduct a new study and
                              submit it within the time frames specified in item 8 above. By indicating that
                              I have chosen this option, I certify that I will comply with all the
                              requirements pertaining to the conditions for submittal of this study as
                              outlined in the Data Call-In Notice and that I will provide the protocols and
                              progress reports required in item 5 above.

    Option 2.                  ON BOTH FORMS:  (Agreement to Cost Share) I have entered into an
                              agreement with one or more registrants to develop data jointly. By
                              indicating that I have chosen this option, I certify that I will comply with all
                              the requirements pertaining to sharing in the cost of developing data as
                              outlined in the Data Call-In Notice.

                                            However, for Product Specific Data, I understand that this
                                     option is available for acute toxicity or certain efficacy data ONLY
                                     if the Agency indicates in an attachment to this notice that my
                                  .   product is similar enough to another product to qualify for this
                                     option. I certify that another party in the agreement is committing to
                                     submit or provide the required data; if the required study is not
                                     submitted on time, my product may be subject to suspension.

    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

                      ,   ,                    ,    142

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                         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
                         ani attempting to upgrade.

Option 6.                 ON BOTH FORMS: (Citing a Study')  I am citing an existing study that
                         has been previously classified by EPA as acceptable, core, core minimum,
                         or a study that has not yet been reviewed by the Agency. If reviewed, I am
                         providing the  Agency's classification of the study.

                                However, for Product Specific Data,  I am. citing another
                         registrant's  study.  I understand that this option is available ONLY for acute
                         toxicity or certain efficacy data and ONLY if the cited study was conducted
                         on my product,  an identical product or a product which the Agency has
                         "grouped" with one or more other products for  purposes of depending on
                         the same data. I may also choose this option if I am citing my own data. In
                         either case,  I will provide the MRID or  Accession number (s).  If I cite
                         another registrant's data, I will submit a completed "Certification With
                         Respect To  Data Compensation Requirements"  form.

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 ani 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

                                           143

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                              of your Confidential Statement of Formula if not already on tile with EPA).
                              I understand that, unless modified by the Agency in writing, the data
                              requirement as stated in the Notice governs.

    FOR PRODUCT SPECIFIC  DATA;  The following option (number 7) is a response that applies to
    the "Requirements Status and Registrant's Response Form" for product specific data.

    Option 7.                 Waiver Request) I request a waiver for this study because it is
                              inappropriate for my product. I am attaching a complete justification for this
                              request, including technical reasons, data and references to relevant EPA
                              regulations, guidelines or policies. [Note: any supplemental data must be
                              submitted in the format required by P.R. Notice 86-5]. I understand that this
                              is my only opportunity to state the reasons or provide information in support
                              of my request. If the Agency approves my waiver request, I will not be
                              required to supply the data pursuant to Section 3(c) (2) (B) of FIFRA. If the
                              Agency denies my waiver request, I must choose a method of meeting the
                              data requirements of this Notice by the due date stated by this Notice. In this
              *                case, I must, within 30 days-of my receipt of the Agency's  written decision,
                              submit a revised "Requirements Status" form specifying the option chosen. I
                              also understand that the deadline for submission of data as specified by the
                              original Data Call-In notice will not change.

Item 10.                      ON BOTH FORMS: This item must be signed by an authorized
                              representative of your company. The person signing must include his/her
                              title, and must initial and date all other pages of this form.

Item 11.                      ON BOTH FORMS: Enter the date of signature.

Item 12.                      ON BOTH FORMS: Enter the name of the person EPA should contact with
                              questions regarding  your response.

Item 13.                      ON BOTH FORMS: Enter the phone number of your company contact.
        NOTE    You may provide additional information that does not fit on this form in a signed letter that accompanies this your response For example you
                may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
                                                 144

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                Attachment 4.
List of Registrants Sent this Data Call-In Notice
                      145

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Page Intentionally Blank
            146

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LIST OF REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # 0247 Name: Bacillus thuringiensis
Company Company Name ' Additional Name
Number
000004 Bomde Products, Inc
000016 Dragon Corp.
000070 Sureco, Inc.
000100 NovarQs Crop Protection, Inc
000192 Dexol Industries
000270 Famam Companies, Inc.
000275 Abbott Laboratories Chemical & Agricultural Products Div
000299 C. J. Martin Co
000524 Monsanto Co Agent for- Monsanto Agricultural Co
000829 Southern Agricultural insecticides, Inc
000869 Green Light Company
001386 Universal Cooperatives, Inc
002935 Wilbur Ellis Co.
003342 Cape Fear Chemicals, Inc
003772 -Bomde Products, Inc Agent for: Earl May Seed & Nursery L.P.
005481 Amvac Chemical Corp Attn: W.F. Millar
005887 Sureco, Inc.
006218 Summit Chemical Co
007401 Voluntary Purchasing Group, Inc
008329 Clarke Mosquito Control Products Inc
008660 H.R. Mclane, Inc. Agent For: Pursell Industries Inc
010107 Corn Belt Chemical Company
010951 Bntz Fertilizers, Inc Attn: David Britz
034704 Cherie' Garner Agent For: Platte Chemical Co Inc
036208 Loveland Industries, Inc Scott Baker
036488 Ringer Corp.
042697 Safer, Inc
049585 Alljack, Division of United Industries Corp.
Address
2 Wurz Ave
Box 73 11
10012 N. Dale Mabry, Ste. 221
Box 18300
1450 w. 228* St
301 W. Osborn Rd
1401 Sheridan Rd, D-28R, Bldg Al
Box 630009
700 14m St, N.W. Suite 1100
Box 218
P.O. Box 17985
P.O. Box 460 7801 Metro Parkway
191 W Shaw Ave
Box 695
2 Wurz Ave
21 10 Da vie Avenue
10012 N. Dale Mabry, Ste. 221
7657 Canton Center Dr
Box 460
159 N Garden Ave
7210 Red Road Suite 206
Box 410
Box 60011
Box 667
Box 1289
9555 James Avenue S., Suite 200
9555 James Avenue S., Suite 200 ,
Box 15842
City & State
Yorkvffle, NY
Roanoke, VA
Tampa, FL
Greensboro, NC
Torrance, CA
Phoenix, AZ
North Chicago, IL
Nacogdoches, TX
Washington, DC
Palmetto, FL
San Antonio, TX
Minneapolis, MN
Fresno, CA
Elizabeth Town, NC
Yorkville, NY
Commerce, CA
Tampa, FL
Baltimore, MD
Bonham, TX
Roselle, IL
Miami, FL
McCook, NE
Fresno, CA
Greeley, CO
Greeley, CO
Bloomington, MN
Bloomington, MN
St Louis, MO
Zip
13495
24019
3361S
27419
90501
85013
60064
75963
20005
34220
78217
55440
93704
28337
13495
90040
33618
21224
75418
60172
33143
69001
93794
80632
80632
55431
55431
63114
                      147

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                           LIST OF REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # 0247   Name: Bacillus thuringiensis
Company Company Name
Number	
Additional Name
                          Address
City & State
                                                                              Zip
053S71   Troy Biosciences, Incorporated                           2620 North 37" Drive

055638   Ecogen, Inc.                                          2005 Cabot Blvd West

059623   California Dept of Food & Agriculture Pesticide Consultation & Analysis   1220 N Street

060372   Ciiy of Stockton             Municipal Utilities Dept       2500 Navy Drive

062637   Becker Microbial Products                               9464 NW 11* St

065247   Calgene, Inc                                          1920 Fifth St

067572   Contract Packaging, Inc.                                Bldg 1, 4132 U.S. Hwy 278

068467   Mycogen Plant Sciences                                 4980 Carroll Canyon Rd

069504   Merdian, LLC                                        5137 14"1 Ave South

070051   Thermo Trilogy Corp.                                  7500 Grace Dr
                                                             Phoenix, AZ

                                                             Langhorne, PA

                                                             Sacramento, CA

                                                             Stockton, CA

                                                             Plantation, FL

                                                             Davis, CA

                                                             Covington, GA

                                                             San Diego, CA

                                                             Minneapolis, MN

                                                             Columbia, MD
                  85009

                  19047

                  95814

                  95206

                  33322

                  95616

                  30209

                  92121

                  55417

                  21044
                                                          148

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                Attachment 5.
Cost Share, Data Compensation Forms, Confidential
   Statement of Formula Form and Instructions
                     149

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               150

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 Instructions for Completing the Confidential Statement of Formula

 The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed copies of the
 form are required.  Following are basic instructions:

 a. All the blocks on the form must be filled in and answered completely.

 b. If any block is not applicable, mark it N/A.

 c. The CSF rmftt be signed, dated and the telephone number of the responsible party must be,provided.

 d. All applicable information which is on the product specific data submission must also be reported on the
 CSF.

 e.All weights reported under item 7 must be in pounds per gallon for liquids and pounds per cubic feet for
 solids.

 f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.                            Y

 g.For all active ingredients, the EPA Registration Numbers for the ^currently registered source products must'
 be reported under column 12.

 h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common names for the
 trade names must be reported.

 i. For the active ingredients, the percent purity of the source ^products must be reported under column 10
 and must be exactly the same as on the source product's label.

 j. All  the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case will
 volumes be accepted. Do not mix English and metric system units (i.e., pounds and kilograms).

 k. All the items under column 13.b. must total 100 percent.

 1. All items under columns 14.a  and 14.b. for the active ingredients must represent pure active form.

 m  The upper and lower certified limits for all 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.
                                                151

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            152

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_ Office of Pesticida Prognms (TS 7671
O CD A Washington. DC 20460
\/ EZ r M Confidential Statement of Formula
1 . Name and Address of Applicant/Registrant (Include ZIP Code)
3. Product Name
EPA USE ONLY








10 Component; in Formulation (List as actually introduced
into the formulation G/ve commonly accepted chemical
name, trade name, and CAS numbtr 1








1— J Basic Formulation
LJ Alternate Formulation
Page
ol
Sea Instructions on Back
2. Name and Address of Producer (Include ZIP Code)
4 Registration No /File Symbol
7. Pounds/Gal or Bulk Density
1 1. Supplier Name & Address







-
5 EPA Product Mgr/Team No
8 pH
12 EPA Reg No

•






1 6. Typed Name of Approving Official
18. Signature of Approving Official

13 Each Component
in Formulation
a. Amount b %t>yW«ijh








17 Total Weight
19. Title



•




100%
6 Country Where Formulated
9 Flash Point/Flame Extension
14 Certified Limits
% by Weight
I Upper Limn b lowtr limit














•

1 5 Purpose in
Formulation









20 Phone No {Include Area Code!
21 Date
EPA Form 8570-4 (Rev. 12-90)    Previous editions are obsolete.   If you can photocopy this, please submit an additional copy White-  EPA File Copy  (original)       Yellow-  Applicant copy

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              154

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    P/EPA
United States  Environmental  Protection  Agency
            Washington,  DC  20460
   CERTIFICATION OF OFFER  TO  COST
SHARE  IN THE DEVELOPMENT OF  DATA
Form Approved

OMB No.  2070-0106
         2070-0057
Approval  Expires 3-31-96
 Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
 time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
 completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
 aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.

 Please fill In blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:

My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.

My firm has offered in writing to enter into such an agreement.  That offer was irrevocable and included an
offer  to be bound  by arbitration decision under section 3{c)(2)(B)(iii} of FIFRA if final agreement on  all
terms could not be reached otherwise. This offer  was made to the following  firm(s) on the following
date(s):
  Name of Flrm(s)
                                                                            Oats of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date .
Name and Title (Please Type or Print)
 EPA Form 8570-32 (5/91)    Replaces EPA Form 8580, which is obsolete
                                                 155

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             156

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                    United States Environmental Protection Agency
                                Washington, DC 20460
                          CERTIFICATION WITH RESPECT TO
                       DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
bhc reporting burden for this collection of information is estimated to average 15 minutes per response including time for
iewing instructions, searching existing data sources gathering and maintaining the data needed, and completing and reviewing the
lection of information.  Send comments regarding the burden estimate or any other aspect of this collection of information,
luding suggestions for reducing this.burden to, Chief Information Policy Branch PM-233, U.S. Environmental Protection
ancy, 401 M St., S.W,, Washmgton/DC 20460, and to the Office of Management and Budget, Paperwork Reduction Project
70-0106), Washington, DC 20503.
sase fill in blanks below.
npany Name
duct Name
Company Number
EPA Reg No
2rtify that:

  For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
rRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
a submitter to cite that study.

  That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
jinal data submitter, or I have obtained the written permission of the original data submitter, or I  have notified in writing the
npany(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those  data in accordance with sections
)(1)(F) and 3(c)(2)(D) of FIFRA- and (b) Commence negotiation to determine which data are subject to the compensation
uirement 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 "R
gistrants1 Response Form"

  That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or reregistrs
lature
Date
ie and Title (Please Type or Print)
 NERAL OFFER TO PAY:  I hereby offer and agree to pay compensation to other persons, with regard to the registration or r
 products, to the extent required by FIFRA section 3(c){1)(F) and 3(c)(2)(D)
lature
Date
 le and Title (Please type or Print)
 >rm 8570-31 (4-96)
                                                      157

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