Reregistration Eligibility Decision (RED): Mineral Acids


          United States         Office of Prevention, Pesticides  EPA 738-R-93-029
          Environmental Protection     And Toxic Substances      December 1993
          Agency           (7508W)
&EPA  Registration
          Eligibility Decision
          Mineral Acids
                                      Printed on Recycled Paper

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                      United States
                      Environmental Protection
                      Agency
                        Prevention, Pesticides
                        And Toxic Substances
                        (7508W)
EPA-738-F-93-025
December 1993
&EPA    R.E.D.    FACTS
          Pesticide
     Reregistration
                      Mineral  Acids
     All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered years ago be reregistered to ensure
that they meet today's more stringent standards.
     In evaluating pesticides for reregistration,  EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide.  The Agency imposes
any regulatory controls that are needed to effectively manage 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 announces this
and explains why in a Reregistration Eligibility  Decision (RED) document.
This fact sheet summarizes the information in the RED for the case mineral
acids, which contains the active ingredients hydrogen chloride, phosphoric
acid, sodium bisulfate, and sulfuric acid.
        Use Profile        The four pesticide active ingredients that comprise the mineral acids
                      reregistration case are used as tuberculocides, disinfectants, sanitizers,
                      virucides, fungicides, desiccants and antimicrobials.  Hydrogen chloride is
                      used as a disinfectant for bathroom, commercial, industrial, institutional,
                      hospital,  laboratory, morgue, refuse, cafeteria and veterinary premises, on
                      surgical instruments, animal cages, swimming pool tile and drinking
                      fountains, and for dishes, glassware and utensils.  Phosphoric acid is used
                      as an antimicrobial in industrial processing water, empty mushroom
                      houses, food and dairy premises and processing plant equipment, animal
                      kennels, hospitals and morgues, and bathroom premises. Sodium bisulfate
                      is used as a disinfectant for toilet bowls.  Sulfuric acid is used as a
                      desiccant on potato crops, and as a sanitizer for food processing and dairy
                      facilities, equipment and utensils. Sulfuric acid is the largest volume
                      chemical produced in the United States, and is used primarily for non-
                      pesticidal purposes.
                           These active ingredients are formulated as emulsifiable, soluble and
                      solid concentrates, ready-to-use liquids, pellets/tablets, solids and
                      impregnated material.

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    Regulatory        The mineral acids were first registered as pesticides in the United
         History   States during the 1950s.  Currently, 212 products are registered which
                    contain the mineral acids as active ingredients.
Human  Health
  Assessment
Toxicity
      All four of the mineral acids are corrosive to the eyes and all except
sodium bisulfate are corrosive to the skin; they have been placed in
Toxicity Category I indicating the greatest degree of acute toxicity for eye
and dermal irritation effects. Sulfuric acid also is extremely acutely toxic
by the inhalation route, and has been placed in Toxicity Category I for
inhalation effects.  The mineral acids otherwise are moderately acutely
toxic, and are placed in Toxicity Category in (on a scale of I to IV) for
acute oral and dermal effects.  (Sulfuric acid,  however, is placed in
Toxicity Category n for acute oral toxicity.)
Dietary Exposure
      Sulfuric acid is the only mineral acid that has a registered food use,
that is,  application to potato vines five or more days prior to harvest to
desiccate the vines and make harvesting less difficult.  Sulfuric acid is
exempt from the requirement of a tolerance for this use.  Sulfuric acid was
granted an exemption from tolerance requirements because it is rapidly
degraded in the environment to sulfate salts, which are of no lexicological
concern and are Generally Recognized as Safe (GRAS) by the Food and
Drug Administration.  There are no human dietary concerns associated
with the potato vine use of sulfuric acid.
Occupational and Residential  Exposure
      Hydrogen chloride and phosphoric acid, which are used mainly as
antimicrobials to sanitize food and dairy processing plants, are applied as
wipe-on surface treatments,  sprays, and circulate in place  (CIP) treatments.
Sodium bisulfate, used as  a disinfectant, is a solid soluble concentrate
which is brushed/swabbed onto the interior surfaces of toilet bowls.
Sulfuric acid, like the first two chemicals, is used to sanitize milk lines and
food processing surfaces by  wipe-on and CIP treatments.  In addition,
concentrated sulfuric acid (93%)  is used to desiccate potato vines prior to
harvest.  A Restricted Use Pesticide, it is applied by certified applicators
using special ground boom type equipment.
     When the four mineral acids are used as antimicrobials, only dilute
solutions are applied to surfaces.  Because the chemicals are applied- at' low
concentrations, mixer/loader/applicator exposure both during and post-
application is likely to be  negligible.
     The use of concentrated  sulfuric acid as  a potato vine desiccant may
result in dermal and inhalation exposure of workers, during and after
treatment, potentially causing severe  irritation to mucous membranes and

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skin. To avoid these effects, product labels must be updated to require
adequate personal protective equipment. In addition, the registrant must
explain the basis for the existing 5-day reentry interval, and demonstrate
that it is sufficiently protective to post-application workers.
Human Risk Assessment
The four mineral acids pose no human dietary risks. People may be
exposed to these chemicals when they are used as antimicrobials, however
this exposure involves such dilute solutions that it is believed to be
inconsequential. The use of concentrated sulfuric acid as a potato desiccant
results in high potential for worker exposure and risk. EPA is maintaining
the existing 5-day reentry interval into treated potato fields, and is
requesting a rationale for this interval. In addition, labels must be updated
to require use of adequate personal protective equipment and clothing, as
specified in the Worker Protection Standard.
Environmental EPA has predicted the environmental fate of the mineral acids in the
Assessment environment using commonly available sources of information, as well as
basic chemistry. The Agency is not able to determine, at this time, if the
use of sulfuric acid as a desiccant on potato vines is eligible for
reregistration. The Agency is concerned about the risk to terrestrial
wildlife, and is not aware of any acceptable methods to mitigate the risk.
In order to determine its eligibility, the Agency will be assessing the
benefits of sulfuric acid for this use. Once this is done, the Agency will
make a finding of whether this use is eligible for reregistration and whether
any further regulatory action is required.
Environmental Fate
The mineral acids generally dissociate and release hydrogen ions in
the environment, thus increasing the pH of soil or water.
Ecological Effects
For all mineral acids and uses except the use of sulfuric acid as a
potato vine desiccant, adequate information is available to predict the
effects on living organisms, so all normally required avian and aquatic
studies were waived. If the mineral acids, diluted or undiluted, came into
contact with birds, they would cause severe dermal toxicity to areas not
covered by feathers. All of the mineral acids pose a potential hazard to the
aquatic environment, due to their ability to change the pH of receiving
waters. Such changes in pH can have serious adverse effects on fish.
Ecological Effects Risk Assessment
Avian species are at risk from direct exposure to mineral acids, and
such exposure must be avoided. Mineral acids also can cause significant
changes in pH, which are harmful to aquatic species and also must be
avoided. These exposures also may be harmful to endangered species.

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                        The risks posed by the mineral acids will be mitigated by product labeling,
                        as specified in the RED document.
                              The use of sulfuric acid as a desiccant on potato vines, however,
                        poses significant hazard to birds  and other terrestrial wildlife.  Since there
                        are no known practical mitigation measures, this use is not eligible for
                        reregistration, at this time.

   Additional Data        EPA is requiring product-specific data, including product chemistry
           Required  a°d acute toxicity studies, as well as revised Confidential Statements of
                        Formula (CSF) and revised labeling, for reregistration of products
                        containing the mineral acids.
  Product Labeling
Changes Required
      All end-use mineral acid products must comply with EPA's current
 pesticide labeling requirements.  In addition:
 0 Compliance with Worker Protection Standard (WPS) - Products used
 in the production of an agricultural plant  or on any agricultural
 establishment (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."
 Unless specifically directed in the RED, all statements required by these
 two PR Notices must appear on product labeling exactly as instructed in
 the Notices.  Labels must be revised by April 21, 1994, for products
 distributed or sold by the primary registrant or supplementally registered
 distributors, and by October 23,  1995,  for products distributed or sold by
 anyone.
 0 Personal Protective Equipment and Reentry Requirements - Sulfuric
 acid,  when used as a potato vine desiccant, has a potential for dermal and
 inhalation exposure to mixer/loader/applicators both during and after
 application. The current label allows for  post-application reentry of
 workers  when wearing appropriate personal protective clothing and
 equipment.  Otherwise post-application reentry is not permitted for 5 days.
 The posting of notices when fields are treated is required.
 °  Effluent Discharge Statement - All end-use and manufacturing use
products that may be contained in an effluent discharged to the waters of
 the United States must bear the following statement:
      "Do not discharge effluent containing this product into lakes,
      streams, ponds,  estuaries, oceans  or other waters unless in
      accordance with the requirements of a National  Pollutant Discharge
      Elimination System (NPDES) permit and the permitting authority has
      been notified in  writing prior to discharge.  Do  not discharge effluent
      containing this product to sewer systems without previously notifying

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the local sewage treatment plant authority. For guidance contact
-. your State Water Board or Regional Office of the EPA."
0 Wildlife Protection Statement - Products containing hydrogen chloride
or phosphoric acid and used in swimming pools must bear the following
statement:
"This pesticide is toxic to wildlife. Do not contaminate water when
disposing of equipment wash water or rinsate."
Regulatory
Conclusion
The use of currently registered pesticide products containing mineral
acids, except use of sulfuric acid as a desiccant on potato vines, in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products are eligible for reregistration.
These products will be reregistered once the required product specific
data, revised Confidential Statements of Formula and revised labeling are
received and accepted by EPA. Products which also contain other active
ingredients will be reregistered after the other active ingredients also are
determined to be eligible for reregistration.
The use of sulfuric acid on potato vines will be subject to further
assessment of its benefits for this use. Once this is done, the Agency will
make a finding of whether this use is eligible and whether any further
regulatory action is required.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Mineral Acids 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 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.
Following the comment period, the Mineral Acids RED 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 Mineral Acids RED, or reregistration of individual products containing
mineral acids, please contact the Special Review and Reregistration
Division (7508W), OPP, US EPA, Washington,' DC 20460, telephone 703-
308-8000.
For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call toll-free 1-800-858-7378, between 8:00 am and 6:00 pm,
Central Time, Monday through Friday.
X-

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REREGISTRATION ELIGIBILITY DECISION

             MINERAL ACIDS

                  LIST D

                CASE 4064
           ENVIRONMENTAL PROTECTION AGENCY
            OFFICE OF PESTICIDE PROGRAMS
        SPECIAL REVIEW AND REREGISTRATION DIVISION

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                         TABLE OF CONTENTS


MINERAL ACIDS REREGISTRATION ELIGIBILITY DECISION TEAM	   i

GLOSSARY OF TERMS AND ABBREVIATIONS 	ii

EXECUTIVE SUMMARY	  iv

I.     INTRODUCTION	   1

H.    CASE OVERVIEW	   2
      A.   Chemical Overview	   2
      B.   Use Profile	•	   3
      C.   Regulatory History	  11

m.   SCIENCE ASSESSMENT	  12
      A.   Human Health Assessment	  12
           1.     Toxicology Assessment 	  12
                  a.    Acute Toxicity	  12
                  b.    Other Toxicological Considerations  	  13
           2.     Exposure Assessment  	  13
                  a.    Dietary Exposure  	  13
                  b.    Occupational and Residential	  14
           3.     Risk Assessment  	  15
      B.   Environmental Assessment	  15
            1.     Environmental Fate	  15
           2.     Ecological Effects  	  16
                  a.    Ecological Effects Data	  16
                       (1)    Avian Effects  .	  17
                       (2)    Aquatic Effects	  18
                  b.    Ecological Effects Risk Assessment	  19

IV.   RISK MANAGEMENT AND REREGISTRATION DECISION	  21
      A.    Determination of Eligibility	  21
            1.     Eligibility Decision	  22
            2.     Eligible and Ineligible Uses   	,	  22
      B.    Regulatory Position	  22
            1.     Tolerance Reassessment	  22
            2.     Restricted Use Classification	  22

V.    ACTIONS REQUIRED BY REGISTRANTS	   23
      A.    Manufacturing-Use Products	  23
            1.     Additional Generic Data Requirements	  23
            2.     Labeling Requirements for Manufacturing-Use Products	  23
      B.    End-Use Products	  24

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            1.    Additional Product-Specific Data Requirements 	  24
            2.    Labeling Requirements for End-Use Products	  24
      C.    Existing Stocks  	,	  25

VI.   APPENDICES	  27
      APPENDIX A. Table of Use Patterns Subject to Reregistration	  29
      APPENDIX B. Table of the Generic Data Requirements and Studies Used
            to Make the Reregistration Decision	145
      APPENDIX C. Citations Considered to be Part of the Data Base Supporting
            the Reregistration of Mineral Acids  	157
      APPENDIX D. List of Available Related Documents	163
      APPENDIX E	167
            PR Notice  86-5	169
            PR Notice  91-2	189
      APPENDIX F. Generic Data Call-In	195
            Attachment 1. Chemical Status Sheet  	215
            Attachment 2. Generic DCI  Response Forms Inserts (Form A) plus
                  Instructions	219
            Attachment 3. Requirements  Status and Registrants' Response Forms
                  Inserts (Form B) plus  Instructions	224
            Attachment 4. List of Registrant(s) sent this DCI (Insert)  	231
      APPENDIX G. Product Specific Data Call-In   	233
            Attachment 1. Chemical Status Sheet  	249
            Attachment 2. Product Specific Data Call-In Response Forms (Form
                  A inserts) Plus Instructions  	251
            Attachment 3. Product Specific Requirement Status and Registrant's
                  Response Forms (Form B inserts) and Instructions  	255
            Attachment 4. EPA Batching of End-Use Products for Meeting Data
                  Requirements for Reregistration	261
            Attachment 5. EPA Acceptance Criteria  	277
            Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                  Notice	'	291
            Attachment 7. Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form	293
      APPENDIX H. Memorandum of Understanding Between the Food and Drug
            Administration, Public Health Service,  Department of Health and
            Human Services and the Environmental Protection Agency  	301
                                 v.
                                    \.

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 MINERAL ACIDS REREGISTRATION ELIGIBILITY DECISION TEAM

 Office of Pesticide Programs:

 Biological and Economic Analysis Division
 Janet Anderson
 Steve Jarboe
 Michele Pethel-Cottrill
 Rafael Prieto
 Cynthia Szymanski

 Environmental Fate and Effects Division

 Brinson Conerly-Perks
 Patrick J. Hannon
 William Schneider
 Harry Winnik

 Health • Effects -Division

 Flora Chow
 Jane Smith

 Registration Division

 Sami Malak
 Alfred Smith
 Robert Travaglini
 Robert Taylor

 Special  Review and Reregistration Division

 Kathryn Scanlon
 Bruce Sidwell

 Office of Compliance Monitoring:

 Phyllis Flaherty

 Office of General Counsel:

Kevin Lee
 Biological Analysis Branch
 Biological Analysis Branch
 Biological Analysis Branch
 Biological Analysis Branch
 Biological Analysis Branch
 Environmental Fate and Groundwater Branch
 Environmental Fate and Groundwater Branch
 Science Analysis and Coordination Staff
 Ecological Effects Branch
Chemical Coordination Branch
Chemical Coordination Branch
Registration Support Branch
Registration Support Branch
Antimicrobial Program Branch
Fungicide-Herbicide Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Pesticides Enforcement Policy Branch
Pesticides Branch

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GLOSSARY OF TERMS AND ABBREVIATIONS

a.i. Active Ingredient

CAS Chemical Abstracts Service

CSF Confidential Statement of Formula

EEC Estimated Environmental Concentration. The estimated pesticide concentration in
an environment, such as a terrestrial ecosystem.

EP End-Use Product

EPA U.S. Environmental Protection Agency

FDA Food and Drug Administration

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA Federal Food, Drug, and Cosmetic Act

GRAS Generally Recognized As Safe as designated by FDA

HDT Highest Dose Tested

LCM 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

LEL Lowest Effect Level

LOEL Lowest Observed Effect Level

MP Manufacturing-Use Product

MPI Maximum Permissible Intake
LD
'so
n

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                    GLOSSARY OF TERMS AND ABBREVIATIONS


 MOE        Margin Of Exposure (PAD)

 MRID       Master Record Identification (number).  EPA's system of recording and tracking
             studies submitted.

 N/A         Not Applicable

 NPDES      National Pollutant Discharge Elimination System

 NOEL       No Observed Effect Level

 OPP         Office of Pesticide Programs

 PADI        Provisional Acceptable Daily Intake

 ppm         Parts Per Million

 Q*i          The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
             Model

 RED         Reregistration Eligibility Decision

RfD         Reference Dose

RS          Registration Standard

TD          Toxic Dose. The dose at which a substance produces a toxic effect.

TC          Toxic Concentration. The dose at which a substance produces a toxic effect.

TMRC       Theoretical Maximum Residue  Contribution.
                                          in

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EXECUTIVE SUMMARY

This Reregistration Eligibility Decision (RED) addresses pesticide uses of hydrogen
chloride, phosphoric acid, sodium bisulfate, and sulfiiric acid in the chemical case mineral
acids. Products containing these active ingredients are used as tuberculocides, disinfectants,
sanitizers, virucides, fungicides, desiccants, and antimicrobials. Registered use sites include
commercial and industrial water cooling tower systems, swimming pool water systems, eating
establishments, eating establishment equipment/utensils, food processing plant equipment,
animals (laboratory/research/commercial/institutional) premise treatment, bathroom
premises/hard surfaces, refuse/solid waste sites, toilet bowls, urinals, a variety of disinfectant
and cleaning uses (hospital, agricultural, dairy), and mushroom houses. The mineral acid active
ingredients are formulated as emulsifiable concentrates, soluble concentrates/liquids, and liquid-
ready to use products.

The U.S. Environmental Protection Agency has determined that, except for the sulfuric
acid potato vine desiccant use, the uses of these four active ingredients as currently registered
will not cause unreasonable risk to humans or the environment and these uses are eligible for
reregistration. The Agency is not able to determine, at this tune, if the use of sulfuric acid as
applied to potato vines is eligible for reregistration. The Agency is concerned about the risk to
terrestrial wildlife and is not aware of any acceptable methods to mitigate the risk. In order to
determine its eligibility, the Agency will be assessing the benefits of sulfuric acid for this use.
Once this is done, the Agency will make a finding of whether this use is eligible for
reregistration and whether any further regulatory action is required.

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

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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 registration" 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 hydrogen chloride, phosphoric acid, sodium bisulfate, and sulfuric acid in
the chemical case mineral acids. The document consists of six sections. Section I is the
introduction. Section II describes these mineral acids, their uses, data requirements and
regulatory history. Section III discusses the human health and environmental assessment based
on the data available to the Agency. Section IV presents the reregistration decision for mineral
acids. Section V discusses the reregistration requirements for mineral acids. Finally, Section VI
is the Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.

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II.    CASE OVERVIEW

      A.    Chemical Overview

            The following active ingredients are covered by this Reregistration Eligibility
      Document:

      1.     Chemical Name:    Hydrogen chloride

            •     Chemical Family:   Inorganic acid

            •     CAS Registry Number:    7647-01-0

            •     OPP Chemical Code:      045901

            •     Empirical Formula: HC1

            •     Trade and Other Names:  Hydrochloric acid


      2.     Chemical Name:    Phosphoric acid

            •     Chemical Family:   Inorganic acid

            •     CAS Registry Number:    7664-38-2

            •     OPP Chemical Code:      076001

            •     Empirical Formula: H3PO4

            •     Trade and Other Names:  Orthophosphoric acid
                                          Phosphorous oxide

      3.     Chemical Name:    Sodium bisulfate

            •     Chemical Family:   Inorganic acid

            •     CAS Registry Number:    7681-38-1

            •     OPP Chemical Code:      073201

            •     Empirical Formula: HNaO4S

            •     Trade and Other Names:  Sodium acid sulfate, Sodium hydrogen
                                          sulfate, and Sodium pyrosulfate

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4.     Chemical Name:    Sulfuric acid

       •      Chemical Family:   Inorganic acid

       •      CAS Registry Number:    7664-93-9

       •      OPP Chemical  Code:      078001

       •      Empirical Formula: H2SO4

       •      Trade and Other Names:  Oil of vitriol


B.     Use Profile

       The following is information on the current registered uses with an overview of
use sites and application methods.  A detailed table of these uses of hydrogen chloride,
phosphoric acid, sodium bisulfate,  and sulfuric acid is hi Appendix A.

       1.  For Hydrogen chloride:

       Type of Pesticide:

              Tuberculocide, disinfectant (bactericide/germicide/purifier, limited,
              general or broad-spectrum, hospital or medical), sanitizer, virucide,
              fungicide/fungistat, and microbicide/microbiostat (slime-forming bacteria)

       Use Sites:

              Indoor non-food - Animals (Laboratory/Research)*, animal
              kennels/sleeping quarters (commercial), commercial/institutional/industrial
              premises/equipment (indoor), commercial storage/warehouse premises
              indoor), commercial transportation facilities-nonfeed/nonfood, donkeys*,
              eating establishments food handling areas (non-food contact), eating
              establishments food serving areas (non-food contact), eating establishments
              non-food areas (non-food contact), fox*, goats (wool/angora animal)*,
              horses (show/race/special/ponies)*,  laundry equipment, mink*, mules
              (work)*, nutria*, rabbits*, sheep*,  specialized animals*,  tobacco
              processing plant premises/equipment

              *Animal equipment and premise treatment.

              Aquatic non-food residential - Swimming pool water systems [water-
              related surface treatment]

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       Indoor food - Dairies/cheese processing plant premises (non-food contact),
       eating establishments, eating establishment equipment/utensils (food
       contact), feed mills/feed processing plants**, fish/seafood processing plant
       premises (non-food contact), food catering facilities premises, food
       dispensing equipment/vending machines**,
       food/grocery/marketing/storage/distribution facility premises, food
       marketing/storage/distribution equipment/utensils (food contact)**, food
       processing plant equipment (food contact), food processing plant premises
       (non-food contact), meat/fish market premises, meat processing plant
       premises (non-food contact), poultry processing plant premises (non-food
       contact)

       **For use on non-food  contact surfaces only.

       Indoor medical - Barber/beauty shop equipment (barber chairs/cabinets),
       barber/beauty shop instruments (shavers/scissors), cuspidors/spittoons,
       hospital/medical institution premises (human/veterinary),  hospital
       conductive floors, hospital/medical institution critical premises (burn
       wards), hospital/medical institution noncritical premises, hospital/medical
       institution patient premises, hospital critical items (surgical
       instruments/pacemakers), hospital janitorial equipment, hospital
       semicritical items (catheters/inhalation equipment), hospital noncritical
       items (bedpans/furniture),  morgues/mortuaries/autopsy/embalming room
       premises, morgues/mortuaries/autopsy/embalming equipment,
       morgues/mortuaries/autopsy /embalming instruments

       Indoor residential - bathroom premises/hard surfaces, household trash
       compactor/food disposals,  incinerators, portable/chemical toilets/latrine
       buckets,  refuse/solid waste containers (garbage cans), refuse/solid waste
       sites (indoor), refuse/solid waste transportation facilities/handling
       equipment, toilet bowls (interior surfaces), toilet tanks/water closets water,
       urinals (interior surfaces),  vehicular holding tanks
Target Pests:
       Mycobacterium tuberculosis, Staphylococcus aureus, Pseudomonas
       aeruginosa, Klebsiella pneumoniae,  Escherichia coli, Streptococcus
       faecalis,  Shigella dysenteriae, Shigella flexneri, Shigella sonnei,
       Salmonella typhi, Salmonella cholerasuis, Salmonella typhimurium,
       Proteus vulgaris, Enterobacter aerogenes, Enterobacter faecalis, Serratia
       marcescens, Trichophyton interdigitale, HIV-1 (AIDS virus), Influenza A2
       virus, Herpes simplex, Type 1  polio virus, Canine parainfluenza virus, and
       Canine reovirus.

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Formulation Types Registered:

       Type: End use

       Form: Emulsifiable concentrate, soluble concentrate/liquid, liquid - ready
             to use   .      '       [•_

Method and Rates of Application:

       Types of Treatment

       Indoor non-food - Disinfectant for laboratory animal, donkey, fox, goat,
       horse, mink, mules, nutria, rabbit, sheep, and zoo animal premises -
       animal equipment treatment, premise treatment, surface treatment - 90,000
       to 237,000 ppm a.i. by weight; 10 ppm a.i. by volume (for laboratory
       animal premises only).
       Disinfectant for animal kennels, warehouses, vehicles,  commercial and
       industrial premises and equipment, laundry equipment, and eating
       establishment non-food areas - mop, scrub, sponge-on, surface treatment,
       swab, transportation vehicle treatment, brush-on,  wipe-on - 90,000 to
       237,000 ppm a.i. by weight; 30,000 ppm a.i. by  volume.

       Aquatic non-food residential - Disinfectant for swimming pool, tile - water-
       related surface treatment - 47,500 ppm a.i. by weight.

       Indoor food -  Disinfectant for eating establishment premises and
       equipment/ utensils, food processing plant equipment - premise treatment,
       immersion, mop, spray - 5 to 86 ppm a.i. by volume.
       Disinfectant for non-food contact areas of meat and fish markets, food
       processing plants, dairy  processing plants, feed mills, meat processing
       plants, poultry processing plants, seafood processing plants, catering
       facilities, food dispensing equipment and  vending machines, and food
       marketing, storage, and distribution equipment -brush-on, mop, scrub,
       sponge-on, surface treatment, swab, wipe-on -90,000 to 237,000 ppm a.i.
       by weight; 30,000 ppm  a.i. by volume.

       Indoor medical  - Disinfectant for barber and beauty shop equipment and
       instruments, cuspidors and spittoons, hospital janitorial equipment,
       hospital noncritical items, hospital critical and noncritical premises,
       hospital patient premises, embalming equipment and instruments, and
       morgues - mop, scrub, sponge-on, surface treatment, swab, wipe-on,
       immersion - 90,000 to 237,000 ppm a.i.  by weight; 5 to 10 ppm a.i. by
       volume.
       Disinfectant for hospital conductive floors - premise treatment - 5 ppm a.i.
       by volume.

-------
        Disinfectant for hospital critical items - immersion - 30 ppm a.i. by
        volume.
        Disinfectant for hospital semicritical items - not on label - 5 ppm a.i. by
        volume.

        Indoor residential - Disinfectant for trash compactors, food disposals,
        incinerators, portable toilets, garbage cans, refuse transportation and
        handling equipment, and vehicular holding tanks - mop, scrub, sponge-on,
        swab,  wipe-on, surface treatment - 90,000 to 237,000 ppm a.i. by weight.
        Disinfectant for bathroom surfaces - brush-on, mop, not on label, pour-on,
        premise treatment, scrub,  sponge-on, surface treatment, swab, wipe-on -
        85000 to 237000 ppm a.i. by weight;  5 to 30000 ppm a.i. by volume.
        Porous surfaces - 6000 ppm a.i. by volume.
        Disinfectant for toilets  and urinals,- brush-on, flush treatment, mop, not
        on label, pour-on, sponge-on, surface  treatment, swab,  scrub - 47100 to
        260000 ppm a.i. by weight; 117 to 24687 ppm a.i. by volume.
        Disinfectant for toilet tanks - surface treatment - 90,000 ppm a.i. by
        weight.

        Equipment - Brush, mop,  tank, sprayer,  sponge, swab,  cloth, package
        applicator, bowl mop, not on label.

       Method and Rate - See Types of Treatment.

       Timing - Not specified.

Use Practice Limitations:

       Some solutions have a rich amber color and as long as the color remains,
       germicidal action is assured. Once the color has disappeared,  the solution
       should be made fresh.  Do not use on  marble or resilient tile floors,
       enamel surfaces, or chrome or nickel-plated plumbing fixtures. Do not
       use with bleach.
2. For Phosphoric acid

Type of Pesticide:  Antimicrobial

Mechanism of Action:  Acidifies,  thus preventing or delay ing growth of target
organisms

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 Use Sites:

       Aquatic nonfood industrial - Industrial processing water

       Greenhouse food crop - Mushroom houses-empty premises/equipment

       Indoor food - Agricultural/farm premises, dairies/cheese processing plant
       equipment, dairy farm milk handling facilities/equipment,  dairy farm
       milking equipment, eating establishments premises/equipment/ utensils,
       egg handling equipment and washing treatments, food dispensing
       equipment, food marketing/storage/distribution equipment/utensils, food
       processing plant equipment/premises, human drinking water systems,
       livestock, meat processing plant equipment/premises, poultry, poultry
       drinking  water, poultry processing plant equipments/premises

       Indoor nonfood - Agricultural/farm equipment, animal kennel/sleeping
       quarters, commercial/institutional/industrial premises/equipment, eating
       establishment and food serving areas, egg plants/hatcheries, mushroom
       houses-empty premises/equipment

       Indoor medical - Hospital critical/semicritical/noncritical items/floors,
       hospitals  critical/noncritical/patient premises, hospitals/medical institutions
       premises,  morgues/mortuaries  equipment/premises

       Indoor residential - Bathroom premises, pet living/sleeping quarters,
       refuse/solid waste containers,  toilet bowls/urinals

Target Pests:

       Staphylococcus aureus, Escherichia coli, Mycobacterium tuberculosis,
       Streptococcus pyogenes, Streptococcus faecalis, Streptococcus salivarius,
       Corynebacterium diptheriae, Salmonella choleraesuis, Salmonella
       paratyphi, Salmonella schottmuelleri, Neisseria elongata, Acinetobacter
       calcoaceticus, Shigella dysenteriae, Enterobacter aerogenes, Proteus
       vulgaris, Proteus mirabilis,  Pseudomonas aeruginosa, Pseudomonas
       cepacia, Klebsiella pneumoniae, Serratia marcescens, Staphylococcus
       aureus (penicillin resistant), Bacillus subtilis  spores, Clostridium tetani
       spores, Clostridium sporogenes spores, Herpes  simplex, Influenza A2
       (Asian), Candida albicans, Trichophyton mentagrophytes, Aspergillus
       niger,  Salmonella typhosa (ATCC  6539), Escherichia coli, (ATCC
       11229), Listeria monocytogenes (ATCC No.  15313), Staphylococcus
       aureus, (ATCC 6538), Herpes simplex type 1,  Influenza A2, influenza
       A2/Hong  Kong, Newcastle disease, vaccinia, adenovirus types 2 and 3,
       Human Immunodeficiency virus type I (AIDS virus), odor  causing
       bacteria, mildew and pathogenic fungi (Trichophyton mentagrophytes,

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       Trichophyton interdigitale, athlete's foot fungi), mold; bacteria and algae,
       slime-forming bacteria and fungi, foulbrood disease, Mycobacterium spp.,
       polioviruses, lipophilic viruses.

Formulation Types Registered:

       Single Active Ingredient Products
       Pelleted/tableted-0.13 %
       Soluble concentrate/liquid—15 to 75.5%
       Liquid ready to use~25%

       Multiple Active Ingredient (a.i.) Products
       Impregnated material—2%  + 1 other a.i.
       Solid concentrate/liquid—0.632 to 57%  + 1 to 4 other a.i.
       Liquid ready to use--0.85 to 45% + 1 other a.i.
       Solid concentrate/solid~29.3% + 1 other a.i.

Methods and Rates of Application:

       Aquatic nonfood industrial - Industrial processing water 35-250 ppm a.i.
       by vol

       Greenhouse food crop -Mushroom houses-empty premises/equipment  150
       ppm a.i. by vol

       Indoor food - Agricultural/farm premises: 625 ppm a.i.  by vol;
       dairies/cheese processing plant equipment: 146 ppm a.i. by weight, 106 -
       3000 ppm a.i.  by vol; dairies/cheese processing plant premises: 148 - 619
       ppm a.i. by vol;  dairy farm milk handling facilities/equipment: 94 - 4688
       ppm a.i. by vol;  dairy farm milking equipment: 47 - 4688 ppm a.i. by
       vol, eating establishments premises/equipment/utensils: 73 - 146 ppm  a.i.
       by weight, 106 - 3516 ppm a.i. by vol; egg handling equipment: 148  ppm
       a.i. by vol; egg washing treatments: 293 ppm a.i. by vol; food dispensing
       equipment: 732 - 3516 ppm a.i. by vol; food
       marketing/storage/distribution equipment/utensils: 625 ppm a.i. by vol;
       food processing plant equipment: 146 ppm a.i. by weight, 25 - 3516 ppm
       a.i. by vol; food processing plant premises: 625 - 750 ppm a.i. by vol;
       human drinking water systems (specific site is drinking fountains):  66,666
       ppm a.i. by  vol, human drinking water systems - water softener salt:
       202,561 ppm a.i. by vol, water softener resin beds: 1300 ppm by weight;
       livestock (housing and equipment):  638 ppm a.i. by vol; meat processing
       plant equipment:  125 - 2637 ppm a.i. by  vol; meat processing plant
       premises:  527  - 625 ppm a.i. by vol;  poultry (housing and equipment):
       625 - 638 ppm a.i by vol; poultry drinking water: 125 ppm a.i by vol;
       poultry processing plant equipment: 125 - 2637 ppm a.i. by vol; poultry


                               8

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       processing plant premises: 527 - 625 ppm a.i. by vol.

       Indoor nonfood - Agricultural/farm equipment: 625 - 3750 ppm a.i. by
       vol; animal kennel/sleeping quarters: 527 ppm a.i. by vol;
       commercial/institutional/industrial premises/equipment: 305 - 1500 ppm
       a.i. by vol; eating establishment and food serving areas: 146 ppm a.i. by
       weight; egg handling equipment: 527 ppm a.i. by vol;  egg
       plants/hatcheries/brooder rooms/shoe baths:  527 - 3750 ppm a.i. by vol;
       mushroom houses-empty premises/equipment: 449 ppm a.i. by vol.

       Indoor medical - Hospital conductive floors: 625 - 738 ppm a.i. by vol;
       hospital critical items: 309 - 879 ppm a.i. by vol, 85,000 ppm a.i. by
       weight; hospital semicritical items: 703 - 2125 ppm a.i. by vol, 85,000
       ppm a.i. by weight; hospital noncritical items: hospital non-conductive
       floors: 250 - 1328 ppm a.i. by vol; hospitals critical premises: 335 - 1328
       ppm a.i. by vol; hospital noncritical premises: 879 - 1500 ppm a.i. by
       vol; hospital patient premises: 638 - 1500 ppm a.i. by vol;
       hospitals/medical institutions premises: 305 - 1500 ppm a.i. by vol,
       120,000 ppm a.i. by weight; morgues/mortuaries equipment/premises: 750
       - 1328 ppm a.i. by vol.

       Indoor residential - Bathroom premises: 531 - 82000 ppm a.i. by vol,
       32000 - 146200 ppm a.i. by weight; pet living/sleeping quarters: 305 ppm
       a.i. by vol; refuse/solid waste containers: 750 ppm a.i. by vol; toilet
       bowls: 1403 - 20833 ppm a.i. by vol, 21000 - 450000 ppm a.i.  by
       weight; urinals: 664 - 18750 ppm a.i. by vol, 21000 - 450000 ppm a.i. by
       weight

Use Practice Limitations:  None
3. For Sodium bisulfate

Type of Pesticide:  Disinfectant

Use Sites: Indoor residential - Interior surfaces of toilet bowls

Target Pests:  Household and Odor-causing bacteria, Staphylococcus spp.

Formulation Types Registered:

       Type: End use

       Form:  Solid-soluble concentrate

-------
 Method and Rates of Application:

       Types of treatment:  Sprinkle

       Equipment: Brash, Swab

       Timing:  As needed

       Rate of application:  From 30400 up to 49248 ppm a.i. by weight

 Use Practices Limitations: None


 4.  For Sulfuric acid

 Type of Pesticide: Sanitizer, desiccant

 Mechanism of Action:  Acidifies

 Use Sites:

 Terrestrial food  + feed crop - White potato

 Indoor food - Dairy/cheese processing plant equipment, dairy farm milking
 equipment and milk handling facilities/equipment, eating establishments
 equipment/utensils, food marketing/storage/distribution equipment/utensils, food
 processing plant equipment

 Target Pests: Animal pathogenic bacteria  (sanitizer use)

 Formulation Types Registered:

 Single Active Ineredient Products
 Liquid ready to use—93 %  (desiccant use)

 Multiple Active  Ingredient (a.i.) Products
 Soluble concentrate/liquid-9.5% + 4 other a.i. (sanitizer use)

Methods and Rates of Application:

Liquid ready to use - At preharvest  of potatoes, apply desiccation treatment at
285 to 391 Ibs a.i./acre.
                               10

-------
Soluble concentrate/liquid - Circulate-in-place or equipment treatment at 1 fl oz
product/6 gal water for a minimum contact time of 2 min.

Use Practices Limitations: Do not apply within 5 days of harvest of potatoes.
C. Regulatory History

Phosphoric acid and hydrogen chloride were registered in the United States as
sanitizers and disinfectants as early as 1958. There are currently 91 phosphoric acid
products and 62 hydrogen chloride products registered for use in or on agricultural
premises, food establishments, commercial/institutional/residential locations, and
hospital/medical institutions on a variety of hard surfaces such as urinals/toilets,
mushroom houses, dairy equipment, food processing equipment, etc. in indoor and
outdoor applications.

Sodium bisulfate was registered in the U.S. as a sanitizer and disinfectant in
1968. There are currently 12 products registered in the U.S. All of these products are
registered for use as toilet bowl cleaners/sanitizers.

Sulfuric acid was registered as a desiccant/herbicide in the U.S. as early as 1971.
Sulfuric acid was exempted from a residue tolerance requirement for this use (40 CFR §
180.1019). A food processing sanitizer emulsion product utilizing sulfuric acid in
combination with other acids was registered in 1992. (FFDCA, § 178.1010 (b)(c),
amended 1992.) There are currently six products registered for agricultural uses
(desiccant/herbicide), and one product (in combination with other active ingredients)
registered as a sanitizer.

Historically, certain phosphoric acid products and certain other liquid chemical
germicides have been regulated both as pesticides under the FIFRA and as devices under
the FFDCA. In an effort to resolve the confusion and burden of dual regulation, a
Memorandum of Understanding (MOU) was signed on June 4, 1993 between EPA and
the Food and Drug Administration (FDA). The objectives of the MOU are to (1)
stimulate both Agencies to undertake rulemaking to permanently vest exclusive
jurisdiction for certain categories of chemical germicides in each Agency and (2) serve
as interim guidance designed to minimize duplicative regulatory requirements between
the two Agencies until the rulemaking is complete.

The MOU separates the liquid chemical germicides into the following two
categories based on their use patterns and efficacy claims: (1) sterilants and (2) general
purpose disinfectants. Sterilants, under this agreement, refer to those chemical
germicides used to reprocess reusable critical and semicritical devices as defined by the
Centers for Disease Control (CDC). Critical devices are devices that are introduced
directly into the human body, either into or in contact with the bloodstream or normally
sterile areas of the body. Semicritical devices are those which contact intact mucous

-------
membranes but which do not ordinarily penetrate the blood barrier or otherwise enter
normally sterile areas of the body. General disinfectants are defined as all remaining
types of public health liquid chemical germicides bearing non-sterilant claims for use on
non-critical surfaces.

The MOU outlines the future separate regulation of liquid chemical germicides as
either pesticides under FIFRA or devices under FFDCA by granting each Agency
primary jurisdiction over one of the two categories. All products which bear sterilant
label claims and can be used on critical or semicritical surfaces will be regulated by
FDA as devices. In addition, many sterilant products have claims which correspond to a
high level disinfectant use pattern. These claims will also be regulated by FDA for the
sterilant products. EPA will regulate the general purpose disinfectants.

Because the MOU does not change the statutory authority granted under FIFRA
and FFDCA, both Agencies will continue to have jurisdiction over all liquid chemical
germicides and will continue registration and premarket approval until rulemaking has
been completed. However, the MOU reduces the regulatory burden by stating that the
required data to support efficacy claims and product performance need only be submitted
and reviewed by the Agency with primary jurisdiction as defined above. In the case of
the phosphoric acid products, EPA has primary jurisdiction and the conditions of
reregistration must be fulfilled and required data submitted as presented in Appendices F
and G.

A copy of the signed EPA/FDA MOU is attached as Appendix H.

HI. SCIENCE ASSESSMENT

A. Human Health Assessment

1. Toxicology Assessment

a. Acute Toxicity

The table below summarizes the toxicity results and categories for technical grade
mineral acids. These data are intended for general reference only.
12

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Acute Toxicity
Test
Oral LD50 (mg/kg)
Dermal LD50
(mg/kg)
Inhalation
Eye Irritation
Dermal Irritation
Skin Sensitization
i SAX, N.I., and Lewis, R.
Sulfuric
Acidi
II (350)
III (>2000)
I (18 mg/m3
guinea piga)
I
I
NR3
Sodium
Bisulfatei
III (3000)
HI(> 10,000)
-
I
IV
NRs
Hydrochloric
Acidi
III (1000)
III (>2000)
-
I
I
NR3
J. SR, Dangerous Properties of Industrial Materials, 7th Ed. Van Nostrand Reinhold,
Phosphoric
Acidi
III (1530)
HI (2740)
-
I
I
NR3
New York, 1989 (pg. 2770).
The data were waived or not required based on the extensive documentation provided in the literature on this chemical.
2 SAX, N.I., and Lewis, R. J. SR, Dangerous Properties of Industrial Materials. 7th Ed. Van Nostrand Reinhold, New York, 1989 (pg. 3147).
3 Not required based on skin and eye irritation data, i.e. toxicity category I.

b. Other Toxicological Considerations

No additional toxicological studies are required for sulfuric acid, hydrochloric acid and
phosphoric acid based on their current use patterns and their corrosiveness as shown in the acute
studies for dermal and eye irritation. Additional toxicology studies are not required for sodium
bisulfate based on the current use patterns and the fact that it forms ubiquitous metabolic
products, sodium and sulfate, that are of little toxicological concern. This applies only to the
technical chemicals and does not apply to end use product data requirements.

2. Exposure Assessment

a. Dietary Exposure

Hydrochloric acid, sodium bisulfate, and phosphoric acid currently have no pesticidal
type food uses. Sulfuric acid has the only related food uses. This use involves application to
potato vines five or more days prior to harvest to desiccate the vines enhancing maturation of
the tubers and making harvesting less difficult. Sulfuric acid is exempt from the requirement of
a tolerance for residues when used in accordance with good agricultural practice as a herbicide
in the production of garlic and onions and as a potato vine desiccant in the production of
potatoes [40 CFR §180.1019]. (It should be noted that currently there are no registered
products for uses of sulfuric acid on garlic and onions.) Sulfuric acid is rapidly degraded in the
environment to yield sulfate ion, which is then available for uptake by plants usually in the form
of ammonium, calcium, potassium, and sodium sulfate (sulfate salts). The exemption was based
on the expectation that sulfuric acid per se would not be found in raw agricultural commodities
13

-------
and that the levels of sulfate salts resulting from the use of sulfuric acid are of no toxicological
concern. The sulfate salts are also generally recognized as safe (GRAS) under 21 CFR
§184.1143, §184.1230, §184.1643, and §186.1797, respectively. Furthermore, calcium sulfate
and sulfuric acid are often present in phosphorous-containing fertilizers as a result of the use of
sulfuric acid in generating wet-process phosphoric acid. There are no human dietary concerns
associated with these chemicals.

b. Occupational and Residential

Hydrogen chloride and phosphoric acid are used mainly as antimicrobials to sanitize food
and dairy processing plants. For these sites, the concentrations of the active ingredient in the
various formulations range from 0.1% to 27.6% hydrogen chloride or 0.1% to 75.5%
phosphoric acid. The methods of application include wipe-on surface treatments, spray, and
circulate-in-place (CIP) treatments. Contact time can be 1 to 15 minutes.

Sodium bisulfate is supplied as a solid/liquid concentrate for indoor residential use as a
disinfectant.

Sulfuric acid (9.5%) is also used to sanitize milk lines and food processing surfaces by
CIP and wipe-on treatments as described for the two acids above. This use is followed by a
chlorinated alkaline cleaner.

Concentrated sulfuric acid (93%) is a Restricted Use Pesticide (RUP) applied by trained
applicators to desiccate mainly white potato vines. This preharvest application "sets" the
potatoes and facilitates harvesting. It is applied by special ground boom type equipment by
certified applicators on potato fields five days prior to harvest. If necessary the application can
be repeated.

There is a potential for post-application dermal and inhalation exposure when the
technical active ingredients hydrogen chloride, phosphoric acid, sodium bisulfate or sulfuric acid
are used as antimicrobials. However, this exposure is very low since only dilute solutions are
used on treated surfaces. Sodium bisulfate is considered toxicity category III (dermal) at
60-70% ai. While the oral and dermal LD50s for hydrogen chloride arid phosphoric acid place
them in toxicity category III, they are considered toxicity category I for dermal and eye
irritation. Since they are applied at low concentrations both mixer/loader/applicator exposure
and post-application worker exposure are likely to be negligible. On the basis of these uses and
toxicology categories, additional mixer/loader/applicator exposure and post-application worker
exposure data for these technical active ingredients for these sites are not required for
reregistration eligibility.

Sulfuric acid (93%), when used as a potato vine desiccant, has a potential for dermal and
inhalation exposure to mixer/loader/applicators both during and after application. This is a
toxicity category I chemical for dermal and eye irritation. Species specific response can result
in inhalation toxicity category I or II classification from studies in guinea pigs and rats,
respectively. The current label allows for post-application reentry of workers when wearing

-------
appropriate personal protective clothing and equipment (PPE). Otherwise post-application
reentry is not permitted for 5 days. The posting of notices when fields are treated is required.
It is feasible that initial post-application exposure to workers reentering potato fields can result
in severe irritation to mucous membranes and skin. Considering the toxicity category I for
dermal irritation and inhalation for concentrated sulfuric acid, the Agency must know on what
basis the registrant established the 5 day reentry interval. The registrant must provide data or a
rationale for the 5 days currently specified on the label versus a longer reentry interval. In the
interim, the Agency requires that workers should not be allowed to reenter treated fields until 5
days have elapsed following treatment with this product. In addition to providing a rationale for
the 5 day interval, the labels must be updated to reflect adequate personal protective clothing
and equipment for mixer/loader/ applicator and post-application workers as required by the
Worker Protection Standards. No further worker exposure data are required for reregistration
eligibility, at this time.

3. Risk Assessment

There are no human dietary concerns associated with these chemicals. There is a
potential for human exposure to sodium bisulfate, hydrogen chloride, phosphoric acid or
sulfuric acid when these chemicals are used as antimicrobials. On the other hand, concentrated
sulfuric acid, when used as a potato vine desiccant, results in a high potential for occupational
exposure from the treated foliage. The Agency requires that an adequate rationale be provided
concerning the 5 day reentry interval into the potato fields. In the interim, The Agency requires
that no one be allowed to reenter a treated field, without PPE, until 5 days have elapsed
following treatment with this product. Lastly, the labels must be updated to reflect adequate
personal protective clothing and equipment as required by the Worker Protection Standards.
B. Environmental Assessment

The fate of acids in the environment is readily predictable using a knowledge of basic
chemistry. Similarly, the effect on living organisms of the pH changes caused by these mineral
acids can be deduced without requiring actual non-target species testing. Using.commonly
available sources of information to assess appropriate protection of the environment, the Agency
has determined that all but one of the currently-registered uses of the mineral acids are eligible
for reregistration. The use of concentrated sulfuric acid on potato vines as a desiccant exceeds
the Agency's level of concern for terrestrial species. Since the Agency is not aware of any
acceptable methods to mitigate this risk, this use is not eligible for reregistration, at this time.

1. Environmental Fate

In general, these acids will dissociate and release hydrogen ions in the environment, thus
increasing the pH. The extent and duration of this increased pH will depend on the amount of
neutralizing ions present, the buffering capacity, and the amount of dilution possible.
15

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Terrestrial Fate

Hvdroeen Chloride

Hydrochloric acid is a solution of hydrogen chloride gas in water. In water there occurs
a complete dissociation of hydrochloric acid to hydronium and chloride ions. The hydronium
ion will lower the soil pH, the extent depending upon the buffering capacity of the soil.
Chloride ion is a natural component of soils, therefore in the absence of copious amounts of
concentrated hydrochloric acid the effect of either ion would be minimal. Neither hydronium
nor chloride ions undergo complex transformations which might affect their ultimate impact on
the environment.

Phosphoric Acid

Phosphoric acid in water is also strongly acidic. Although, in addition to a variety of
indoor uses, phosphoric acid is used in industrial water cooling systems and swimming pool
water systems, no significant exposure to terrestrial organisms is expected.

Sodium Bisulfate

Sodium bisulfate in water is strongly acidic. However, because of the limited indoor
use of this chemical, environmental exposure is not expected.

Sulfuric Acid

Sulfuric acid is the largest volume chemical produced in the United States and serves
mainly non-pesticidal purposes. Sulfuric acid in water dissociates to hydronium and sulfate
ions. The effects on the environment of these ions resulting from the anticipated concentrations
due to the potato vine desiccant use are moderated by natural means. There is no potential for
either ion to be significantly accumulated by the biota.

2. Ecological Effects

a. Ecological Effects Data

Adequate information is available to predict the effect of these acids on living organisms.

For All Mineral Acids and All Uses EXCEPT the Potato Vine Desiccant Use of Sulfuric Acid
16

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       The following four studies would normally be required for all of the mineral acids to
provide data for labeling statements concerning non-target species:

71-l(a):       acute avian oral, quail/duck (TGAI)
71-2(b):       acute avian diet, duck (TGAI)
72-l(c):       acute fish toxicity/rainbow trout (TGAI)
72-2(a):       acute aquatic invertebrate toxicity (TGAI)

       Since there is sufficient information regarding the toxic and corrosive nature of the
mineral acids all avian and aquatic studies have been waived for these uses.

Sulfuric Acid Potato Vine Desiccant Use

       The following six studies would normally be required for the sulfuric acid potato vine
desiccant use to provide data for a risk assessment and labeling:

71-l(a):       acute avian oral, quail/duck (TGAI)
71-2(a):       acute avian diet, quail (TGAI)
71-2(b):       acute avian diet, duck (TGAI)
72-1 (a):       acute fish toxicity/bluegill sunfish (TGAI)
72-l(c):       acute fish toxicity/rainbow trout (TGAI)
72-2(a):       acute aquatic invertebrate toxicity (TGAI)

       Since there is sufficient information regarding the toxic and corrosive nature of sulfuric
acid, all data requirements have been waived.

       In lieu of Agency guideline quality submitted data on this product, the following
information was used to support the ecological effects risk assessment.

                           (1)     Avian Effects

       Information on another pesticide documented the potential for adverse effects from acids
on avian species.  One study was submitted to EPA showing that birds sprayed directly in field
pens with both dilute («2.1 Molar solution) and undiluted («7.03 Molar solution) forms of
Enquik (N-TAC, Sulfuric Acid, Monourea adduct) exhibited dermal toxicity effects to areas that
were not covered by feathers.  Specifically, the eyes and feet were burned by the sulfuric acid
released.  The birds also showed a significant increase in hemorrhagic enteritis (a severe
irritation of the gastrointestinal tract). Another pen study showed dermal toxicity effects to
birds after varying reentry times following spraying on alfalfa with dilute Enquick.
                                             17

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(2) Aquatic Effects

Since all of the mineral acids pose a potential hazard to the aquatic environment not
because of inherent toxicity but instead due to their ability to change the pH of receiving waters
the following discussion, excerpted from: USEPA, 1976, Quality Criteria for Water, pages
178-181, deals with pH and its potential hazard to aquatic organisms. This section also notes
safe pH ranges:

"pH" is a measure of the hydrogen ion activity in a water sample. It is mathematically
related to hydrogen ion activity according to the expression: pH= -Iog10 [H+], where [H+] is
the concentration of the hydrogen ion.

The pH is an important factor in the chemical and biological systems of natural waters.
The degree of dissociation of weak acids or bases is affected by changes in pH. This effect is
important because the toxicity of many compounds is affected by the degree of dissociation.
For example, rapid increases in pH can cause increased NH3 concentrations which are toxic.

A review of the effects of pH on freshwater fish has been published by the European
Inland Fisheries Advisory Commission (EIFAC,1969). The Commission concluded:

There is no definite pH range within which a fishery is unharmed and outside which it is damaged, but
rather, there is a gradual deterioration as the pH values are further removed from the normal range.
The pH range which is not directly lethal to fish is 5-9; however, the toxicity of several common
pollutants is markedly affected by pH changes within this range, and increasing acidity or alkalinity
may make these poisons more toxic. Also, an acid discharge may liberate sufficient CO2 from
bicarbonate in the water either to be directly toxic, or to cause the pH range 5-6 to become lethal.

Based on present evidence, a pH range of 6.5 to 9.0 appears to provide adequate
protection for the life of freshwater fish and bottom dwelling invertebrate fish food organisms.
Outside of this range, fish may suffer adverse physiological effects increasing in severity as the
degree of deviation increases until lethal levels are reached.

For open ocean waters where the depth is substantially greater than the euphoric zone,
the pH should not be changed more than 0.2 units from the naturally occurring variation or in
any case outside the range of 6.5 to 8.5. For shallow, highly productive coastal and estuarine
areas where naturally occurring pH variations approach the lethal limits for some species,
changes in pH should be avoided but in any case should not exceed the limits established for
fresh water, i.e., pH of 6.5 to 9.0.
18

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b. Ecological Effects Risk Assessment

For All Mineral Acids and All Uses EXCEPT the Potato Vine Desiccant Use of Sulfuric Acid

There is sufficient information regarding the toxic and corrosive nature of the mineral
acids. Avian species are at risk from direct exposure to mineral acids and such exposure must
be avoided. The major potential aquatic hazard of mineral acids lies hi their ability to change
pH of receiving waters. Sufficient exposure to mineral acids to significantly change the pH is
harmful to aquatic species and such exposure must be avoided. Similarly, any such terrestrial
or aquatic exposure may be harmful to endangered species.

Sulfuric Acid Potato Vine Desiccant Use

Since there is sufficient information regarding the toxic and corrosive nature of sulfuric
acid, all data requirements have been waived. The studies submitted to EPA for Enquik (N-
TAC, sulfuric acid, Monourea adduct) demonstrated the potential for adverse avian effects as
documented above. Since the concentration of sulfuric acid produced by Enquik (dilute =2.1,
undiluted = 7.03 Molar solution) is much less than the 93% used as a potato desiccant ( = 9.48
Molar solution), use of 93% sulfuric acid as a potato vine desiccant exceeds the Agency's level
of concern for terrestrial wildlife.

Precautionary Labelling:

Manufacturing Use for All Mineral Acids and Phosphoric Acid for Use in Industrial Water
Cooling Tower Systems

This pesticide is toxic to wildlife. "Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified hi 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."

Hydrogen Chloride and Phosphoric Acid for Use in Swimming Pools

This pesticide is toxic to wildlife. Do not contaminate water when disposing of
equipment wash water or rinsate.
19

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Indoor Uses for All Mineral Acids

                           Effluent Discharge Labeling Statements

                     All manufacturing-use or end-use products that may be contained in an
              effluent discharged to the waters of the United States or municipal sewer systems
              must bear the following revised effluent discharge labeling statement.

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

                     All affected products distributed or sold by registrants and distributors
              (supplemental registrants) must bear the above labeling by October 1, 1995. All
              products distributed or sold by persons other than registrants or supplemental
              registrants after October 1, 1997 must bear the correct labeling. Refer to PR
              Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.

Data Requirements:

       There are no outstanding data requirements to support the present uses of the mineral
acids (hydrogen chloride,  sulfuric acid, phosphoric acid, sodium bisulfate).

Conclusion:

For All Mineral Acids and All Uses EXCEPT the Potato Vine Desiccant Use of Sulfuric Acid

       The potential risks of the mineral acids to non-target organisms will be mitigated through
labelling statements.

Sulfuric Acid Potato Vine Desiccant Use

       Use of 93% sulfuric acid as a potato vine desiccant is expected to pose significant hazard
to terrestrial wildlife.  Since the risk is focused  in the treated  field and occurs during treatment
and continues  for a number of hours after treatment, there are no known practical mitigation
measures.  Therefore, this use exceeds the Agency's level of concern for risk to terrestrial
wildlife.
                                            20

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Endangered Species

At the present time, the Agency is working with the U.S. Fish and Wildlife
Service and other federal and state agencies to develop a program to avoid
jeopardizing the continued existence of listed species by the use of pesticides.
When the Endangered Species Protection Program is implemented and subsequent
guidance is given, endangered species labeling amendments may be required on
affected end-use products. Labeling statements for end-use products will likely
refer users to county specific bulletins specifying detailed limitations on use to
protect endangered species.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION

A. v Determination of Eligibility

Section 4(g)(2)(A) of FIFRA calls for the. Agency to determine, after submission
of adequate data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has identified the generic (i.e.
active ingredient specific) data required to support reregistration of products containing
mineral acid 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 mineral acids except for the use of sulfuric acid on potato vines.
Appendix B identifies the generic data requirements that the Agency reviewed as part of
its determination of reregistration eligibility of mineral acids, and lists the submitted
studies that the Agency found acceptable.

The Agency is not able to determine, at this time, if the use of sulfuric acid as
applied to potato vines is eligible for reregistration. The Agency is concerned about the
risk to terrestrial wildlife and is not aware of any acceptable methods to mitigate the
risk. In order to determine its eligibility, the Agency will be assessing the benefits of
sulfuric acid for this use. Once this is done, the Agency will make a finding of whether
this use is eligible for reregistration and whether any further regulatory action is
required.

Even though the use on potato vines is not eligible at this time, if the registrants
of these sulfuric acid products still wish to support them for reregistration, they must
comply with all appropriate product specific labeling and data requirements including
data or an adequate rationale in support of the 5-day post-harvest re-entry interval.

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 and the data identified in Appendix B. Although the
Agency has found that most uses of mineral acids 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 mineral
acids 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 mineral acids,
the Agency has sufficient information on the health effects of mineral acids and on its
potential for causing adverse effects in fish and wildlife and the environment.
Therefore, the Agency concludes that products, labeled and used as specified in this
Reregistration Eligibility Decision, containing mineral acids for all uses except for the
use of sulfuric acid on potato vines, are eligible for reregistration.

2. Eligible and Ineligible Uses

The Agency has determined that all uses of mineral acids except for the
use of sulfuric acid on potato vines, are eligible for reregistration.

B. Regulatory Position

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

1. Tolerance Reassessment

Sulfuric acid is exempt from the requirement of a tolerance for residues when
used in accordance with good agricultural practice as a herbicide in the production of
garlic and onions and as a potato vine desiccant in the production of potatoes [40 CFR
§180.1019]. (It should be noted that currently there are no registered products with uses
of sulfuric acid on garlic and onions.) Sulfuric acid is rapidly degraded in the
environment to yield sulfate ion, which is then available for uptake by plants usually in
the form of ammonium, calcium, potassium, and sodium sulfate (sulfate salts). The
exemption was based on the expectation that sulfuric acid per se would not be found in
raw agricultural commodities and that the levels of sulfate salts resulting from the use of
sulfuric acid are of no toxicological concern.

2. Restricted Use Classification

Sulfuric acid products to be applied as a desiccant to potato vines are currently
Restricted Use Products, i.e. their mixing, loading, and application may only be done by
or under the direct supervision of an (EPA) Certified Applicator. This classification was
enacted historically to protect human health.
22

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V. ACTIONS REQUIRED BY 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

1. Additional Generic Data Requirements

The generic data base supporting the reregistration of mineral acids for the
above eligible uses has been reviewed and determined to be substantially complete
except for one requirement for sulfuric acid. Registrants of the products which
contain sulfuric acid for use on potato vines are required to provide data or a
rationale for foliar residue dissipation corresponding to series 132-l(a).

2. Labeling Requirements for Manufacturing-Use Products

Effluent Discharge Labeling Statements

All manufacturing-use or end-use products that may be contained in an
effluent discharged to the waters of the United States or municipal sewer systems
must bear the following revised effluent discharge labeling statement.

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

All affected products distributed or sold by registrants and distributors
(supplemental registrants) must bear the above labeling by October 1, 1995. All
products distributed or sold by persons other than registrants or supplemental
registrants after October 1, 1997 must bear the correct labeling. Refer to PR
Notice 93-10 or 40 CFR 152.46(a)(l) for additional information.
23

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B. End-Use Products

1. Additional Product-Specific Data Requirements

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

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

2. Labeling Requirements for End-Use Products

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

In the course of the reregistration of phosphoric acid and hydrogen
chloride, the Agency has become aware of a number of products that make
claims regarding disinfection of critical items (surgical instruments) and semi-
critical items (catheters, endoscopes, respiratory apparatus, etc.). [See discussion
in Section 2.C. "Regulatory History" above and Appendix D "FDA/EPA
Memorandum of Understanding"].

The Agency believes that, in fact, these products are general purpose
disinfectants and therefore, these claims for disinfection of critical items and
semi-critical items must be removed from the labels.

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 9311, "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

24-

-------
       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.
       Effluent Discharge Labeling Statements

              Refer to subsection A. above for labeling requirements for effluent
       discharge.

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 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; State of
Policy"; Federal Register. Volume 56, No.  123, June 26,  1991.

       The Agency has determined that registrants may distribute and sell mineral acid
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.
                                     25

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26

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VI.   APPENDICES
       27

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28

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APPENDIX A.  Table of Use Patterns Subject to
                Reregistration
                     29

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30

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APPENDIX B.  Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
                         145
-------
146
-------
                               GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case mineral acids covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to mineral acids in all products,
including data requirements for which a "typical formulation" is the test substance.

      {The data table is organized in the following format:

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

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

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

      3. Bibliographic citation (Column 3). If the Agency has acceptable data in. its files,
this column lists the identify ing 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.
                                          147
-------
148
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  APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Mineral Acids
                         157
-------
158
-------
                               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 in
       this bibliography have been the body of data submitted to EPA and its predecessor
       agencies in support of past regulatory decisions.   Selections from other sources
       including the published literature, in those instances where they have been considered,
       are included.

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

3.     IDENTIFICATION OF ENTRIES.  The entries  in this bibliography are sorted
       numerically by Master Record Identifier, or "MRID number". This number is unique
       to the citation, and should be used whenever a specific reference is required.  It is not
       related to the six-digit "Accession Number"  which has been used to identify volumes
       of submitted studies (see paragraph 4(d)(4) below for further explanation).  In a few
       cases, entries added to the bibliography late  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 document.
             When the date is followed by a question mark, the bibliographer has deduced

                                          159
-------
       the date from the evidence contained in the document.  When the date appears
       as (19??), the Agency was unable to determine or estimate the date of the
       document.

c.     Title. In some cases,  it has been necessary for the Agency bibliographers to
       create or enhance a document title.  Any such editorial insertions are contained
       between square brackets.
.  ,>
d.     Trailing parentheses.   For studies submitted to the Agency in the past, the
       trailing parentheses include (in addition to any selfrexplanatory 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 hi turn followed
             by an alphabetic suffix which shows the relative position of the study
             within the volume.
                                   160
-------
                                BIBLIOGRAPHY

MRID                         CITATION
             Bogan, P.  ES Research and Development Laboratory Static Acute Toxicitv
             Fish Bioassay Complies with the State Water Resources Control Board.
             Department of Fish and Game [unpublished study], 1981.

             "Chemistry of N-Tack". Union Oil Co. of California [unpublished study],
             1982.

             Quality Criteria for Water. United States Environmental Protection Agency,
             1976.

             A Review of the  Effects of pH on Freshwater Fish. European Inland Fisheries
             Advisory Commission, 1969.

             Robinson, S.; Sherman, H. Oral LD50 Test: G.B.S. Globular Sodium
             Bisulfate Technical. Haskell Laboratory Report [unpublished study],  1967
             prepared by E.I. du Pont de Nemours and Co., submitted by Drackett Co.,
             Cincinnati, OH; CDL:250945-A)

             SAX, N.I., and Lewis, R. J. SR,  Dangerous Properties of Industrial
             Materials. 7th Ed. Van Nostrand Reinhold, New York, 1989.

             "Summary of Toxicity Data: Experimental Herbicide Formulation". ES Unilab
             Research, Inc. [unpublished study], 1981.

             Trent, L.; Hestand, R.; Carter, C. "Toxicity of Sulfuric Acid to Aquatic
             Plants and Organisms."  Journal of Aquatic Plant Management. 1978.
                                        161
-------
162
-------
APPENDIX D.  List of Available Related Documents
                     163
-------
164
-------
       The following is a list of available documents related to mineral acids.  It's purpose is
to provide a path to more detailed information if it is needed.  These accompanying
documents are part of the Administrative Record for mineral acids and are included in the
EPA's Office-of Pesticide Programs Public Docket.

       1.     Health and Environmental Effects Science Chapters

       2.     Detailed Label Usage Information System (LUIS) Report

       3.     Mineral Acids RED Fact Sheet

       4.     PR Notice 86-5 (included in this appendix)

       5.     PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
             Statement
                                          165
-------
-------
APPENDIX E.  PR Notices 86-5 and 91-2
                  167
-------
168
-------
PR Notice  86-5
      169
-------
170
-------
               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                             WASHINGTON, D.C.  20460

                                  July 29, 1986

                                                            OFFICE OF
                             PR NOTICE 86-5            PREVENTION, PESTICIDES
                                                      AND TOXIC SUBSTANCES

     .  .j,   NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
                         AND REGISTRANTS

Attention:   .   Persons responsible  for Federal registration of
                pesticides.

Subject:      .  Standard  format for  data  submitted under the
                Federal Insecticide,  Fungicide,  and Rodenticide
                Act  (FIFRA)  and certain provisions of the Federal
                Food,  Drug,  and Cosmetic  Act (FFDCA) .-

I.    Purpose                •

     To require data  to  be  submitted to  the Environmental
Protection Agency  (EPA)  in  a standard  format.  This Notice also
provides additional .guidance about,  and  illustrations of, the
required formats.

II.  Applicability

     This PR Notice applies to all  data  that are submitted to EPA
to satisfy data requirements for  granting or maintaining
pesticide registrations, experimental  use permits,  tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA.  These data are defined in FIFRA  §10(d)(1).   This Notice
does not apply  to commercial, financial,  or production
information, which are,  and must  continue to be,  submitted
differently under separate  cover.

III. Effective  Date

     This notice is effective on  November 1,  1986.  Data formatted
according to this notice may be submitted prior to the effective
date.  As of the effective  date,  submitted data packages that do
not conform to  these  requirements may  be returned to the
submitter for necessary  revision.

IV.  Background

     On September 26, 1984,  EPA published proposed regulations in
the Federal Register  (49 FR .37956)  which include Requirements for
Data Submission (40 CFR.  §158.32), and  Procedures for Claims  of
Confidentiality of Data  (40 CFR §158.'33) .  These regulations


                               171
-------
specify the format for data submitted to EPA under Section 3 of
FIPRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality.  No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.

     OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V.
Relationship of this Notice to Other OPP Policy and Guidance
     While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves.  "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be compatible with submittal format
requirements described in this Notice.

     OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3.  The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages.  As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.

     OPP has also established a public docket which imposes
deadlines for inserting into the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32).  To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.

     For several years, OPP has required that each application
for registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support for the application.
Typically, many requirements are satisfied by reference to data
previously submitted--either by the applicant or by,another
party.  That requirement is not altered by this notice, which
applies only to data submitted with an application.

VI.  Format Requirements

     A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached.  Except for -the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered,  these samples
are illustrative.  As long as the required information is
included and clearly identifiable, the form of the samples may be
altered- to reflect the submitter's preference.

                               172
-------
                             -  INDEX-
                                                            Text Example
                                                            Page   Page
A.   Organization of the Submittal Package	3      17

B.   Transmittal Document  ..... 	  4      11

C.   Individual Studies ....  	  4

     C. 1  Special Considerations for Identifying Studies  .  .  5

D.   Organization of each Study Volume	6      17
     ,  ,;
     D- 1  Study Title Page	7      12
     D. 2  Statement of Data Confidentiality Claims
                  (based on FIFRA §10 (d) (1) )   	8      13
     D. 3  Confidential Attachment  ....... 	  8      15
     D. 4  Supplemental Statement of Data Confidentiality
            Claims (other than those based on FIFRA §10(d)(1) ) 8      14
     D. 5  Good Laboratory Practice Compliance Statement   .  .  9      16

E.   Reference to Previously Submitted Data  .  .  .	  9

F.  ,Physical,Format.Requirements & Number of Copies   ....  9

G.   Special Requirements for Submitting Data to the Docket   10

                             **************

A.   Organization of Submittal Package

     A "submittal package" consists of all studies submitted at
the same time for review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4,  8570-20, etc.) as appropriate.

     Data submitters must organize each submittal package as
described in this Notice.   The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume.  Each study included in the submittal package must then
be bound separately.

     Submitters sometimes provide additional materials that are
intended to clarify,  emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.

     - . If such materials relate to one study, they should be
     included as an appendix to that study..

     - If such materials relate to more than one study  (as for
     example a summary of all studies in a discipline) or to the
     submittal in general, they must be included in the submittal
     package as- a separate study  (with-title page and statement
     of confidentiality claims).
                               173
-------
B.   Transmittal Document

     The first item in each submittal package must be a trans-
mittal document.  This document identifies the submitter_or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e., a registration application,
petition, experimental use permit (EUP), §3(c)(2)(B) data
call-in, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s)  addressed by
each one.  The EPA-assigned number for the regulatory action
(e.g* .the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter.  See Attachment 1 for an example of an
acceptable transmittal document.

     The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.

     The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,	 of the petition or application, as defined in 40 CFR 180.7
and 158.125,  (petitions) or Pesticide Assessment Guidelines,
Subdivision I  (EUPs) as appropriate.

    • When a submittal package supports a tolerance petition_and
an application for a registration or an EUP,  list the petition
studies  first, then the balance of the studies.  Within these two
groups of studies follow the instructions above.

C.   Individual Studies

     A study  is the report of a single scientific investigation,
including all  supporting analyses required for logical complete-
ness.  A study should be identifiable  and distinguishable by a
conventional bibliographic citation including author, date, and
title.   Studies generally  correspond in  scope to a  single Guide-
line requirement for supporting data,  with some  exceptions  dis-
cussed in section C.I.  Each study included in a submittal
package  must be bound as a  separate entity.   (See comments  on
binding  studies on page 9.)

     Each study must.be consecutively  paginated, beginning  from
the  title page as page 1.   The  total number of pages  in the com-
plete study must be shown  on the  study title  page.   In addition
 (to  ensure  that  inadvertently separated pages can be  reassociated
with the proper  study during handling  or review) use  either of
the  following:

     -  Include the total number.of pages- in-the  complete  study on
     each page (i.e.,  1 of 250,'  2 of 250,  ...250 of 250).

     -  Include a company name or mark  and  study number on each
     page of  the study, e  g , Company  Name-1986-23.   Never reuse
     a•study  number for marking the pages  of  subsequent studies.

                                174
-------
     When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.

C.I  Special Considerations for Identifying Studies

     Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.

     a. Safety Studies.  Several Guidelines require testing for
safety .tf.n more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately. '

     Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc-
iated with safety studies.  Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices.  When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.

     Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.

     b. Product Chemistry Studies.   All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.

     Product chemistry data submitted in support of a technical
product, other manufacturing-use product,  an experimental use
permit, an import tolerance petition,  or an end-use product
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61,  62, and 63) for
conventional pesticides, or for the equivalent subject range for
biorational pesticides.   The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10,  151-11,  and 151-12; the second
would cover Guidelines 151-13,  151-15,  and 151-16; the third
would cover. Guideline 151-17.  The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21,  and 151-22; the
second would cover Guidelines 151-23 and 151-25;  the third would
cover Guideline 151-26.

     Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A),  (B),  or (C), and if so must be handled as described
in section D.3.  of this notice.
                               175
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     c.  Residue Chemistry Studies.   Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code.  The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully.  Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop.  When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such commodities should be reported as a single study.  When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
     Each complete study must include all applicable elements in
the list below, in the order indicated.   (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs.   Entries in the column headed  "example"- cite the
page number of this notice where the element is illustrated.
Element

Study Title Page

Statement of Data
Confidentiality
Claims

Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices

Cover Sheet to Confi-
dential Attachment
                    When Required                 Example

                    Always                        Page 12

                    One of the two alternative    Page 13
                    forms of this statement
                    is always required

                    If study reports laboratory   Page 16
                    work subject to GLP require-
                    ments

                    For 'certain toxicology studies  (When
                    flagging requirements are finalized.)

                    Always - with an English language
                    translation if required.

                    At submitter's option

                    If CBI is claimed under FIFRA
                    §10 (d) (1) (A) ,  (B) , or  (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
                    If CBI is claimed under FIFRA
                    §10 (d) (1) (A) ,  (B) , or  (C)     Page 15

                    Only if confidentiality is    Page 14
                    claimed on a basis other than
                    FIFRA. §10.(d) (l)-(A) -,,  (B) , or  (C).
                                176
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D.I. Title Page

     A title page  is always  required  for each  submitted  study,
published or unpublished.  The  title  page must always be freely
releasable to requestors; DO NOT  INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable  title page  is on page  12 of  this
notice.  The following  information must appear on  the title page:

a.   Study title.  The  study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the  name  of the data requirement as  it appears in
the Guidelines.
     • >}
b.   Data requirement addressed.  Include on the title page the
Guideline number(s) of  the specific requirement(s) addressed by
the study.

c.   Author(s).  Cite only individuals  with primary intellectual
responsibility for the  content  of the study.   Identify them
plainly as authors, to  distinguish them from the performing
laboratory, study  sponsor, or other names that may also.appear  on
the title page.

d. .  Study. Date...  The title  page  must include  a single date for
the study.  If parts of the  study were  performed at different
times, use only the date of  the latest  element in  the study.

e.   Performing Laboratory Identification.  If the study reports
work done by one or more laboratories,  include on  the title page
the name and address of the  performing  laboratory  or
laboratories, and  the laboratory's internal project number(s) for
the work.  Clearly distinguish  the laboratory's project
identifier from any other reference numbers provided-by  the study
sponsor or submitter.

f•   Supplemental  Submissions.  If the  study is a  commentary on
or supplement to another previously submitted  study, or  if it
responds to EPA questions raised  with respect  to an earlier
study, include on  the title  page  elements a. through d.  for the
previously submitted study,   along with  the EPA Master Record
Identifier (MRID)  or Accession number of the earlier study if you
know these numbers.  (Supplements submitted in the same  submittal
package as the primary study should be  appended to and bound with
the primary .study.   Do not include supplements  to more than one
study under a single title page).

9-    Facts of Publication.   If the study is a reprint of a pub-
lished document,  identity on the  title page all relevant  facts of
publication,  such  as the journal  title,  volume, issue,  inclusive
page  numbers,  and publication date.
                               177
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D.2. Statements of Data Confidentiality Claims Under FIFRA
     Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33  (b) and (c)   (See
Attachment 3) .  These statements apply only to claims of data
confidentiality based on FIFRA §10 (d) (1) (A) ,  (B) , or  (C) .  Use
the appropriate alternative form of the statement either to
assert a claim of §10 (d) (1) data confidentiality  (§158. 33 (b)) or
to waive such a claim (§158 .33 (c) ) .  In either case, the
statement must be signed and dated, and must include the typed
name .and title of the official who signs it.  Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions  (see NOTE Pg 13) .

D.3. Confidential Attachment

     If the claim is made that a study includes confidential  .
business information as defined by the criteria of FIFRA
§10 (D) (1) (A), (B) , or (C)   (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5) .

     The Confidential Attachment to a study must be identified by
a cover' sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment."  An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet.  Paginate 'the Confidential Attachment
separately from the body of the study,  beginning with page 1 of X
on the title page.  Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage (s) of FIFRA
§10 (d) (1) on which the confidentiality claim is based.

D.4. Supplemental Statement of Data Confidentiality Claims (See
     Attachment 4)

     If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10 (d)
(1) (A) ,  (B) , or  (C) , the following provisions apply:

     - The specific information to which the claim applies must
     be clearly marked in the body of the study as subject to a
     claim of confidentiality.

     - A Supplemental Statement of Data Confidentiality Claims
     must be submitted,  identifying each passage claimed confi-
     dential and describing in detail the basis for the claim.
     A list of the points to address .in- :such a statement is
     included in Attachment 4 on Pg 14 .

     - The Supplemental Statement of Data Confidentiality Claims
     must be signed and dated and must include the typed name and
     title of the official who signed it .

                               178
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D.5. Good Laboratory Practice Compliance Statement

     This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160.  Sam-
ples of these statements are shown in Attachment 6.

E.   Reference to Previously Submitted Data

     DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it.   A copy
of the title page plus the MRID number  (if known) is sufficient
to allow us to retrieve the study immediately for review.  This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study.  References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of'support for the application.

F.   Physical Format Requirements

     All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resolution.  Bindings for
individual studies,, must .be secure, but easily removable to permit
disassembly for microfilming.  Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.

Please be particularly attentive to the following points:

     •    Do not include frayed or torn pages.

     •    Do not include carbon copies, or copies in other than
          black ink.

     •    Make sure that photocopies are clear, complete, and
          fully readable.

     •    Do not include oversize computer printouts or fold-out
          pages.

     •    Do not bind any documents with glue or binding tapes.

     •    Make sure that all pages of each study, including any
          attachments or appendices, are present and in correct
          sequence.

     Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
 (See Part G below) must be provided In three complete, identical
copies.   (The'proposed regulations specified.two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it-into review.)    .  «-,,.  .,,t,.r   .„,.,
                                179
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G.
Special Requirements for Submitting Data to the Docket
     Data submittal packages associated with a Registration- Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised.  This
fourth copy will become part of the public docket for the RS or
SR case.  If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three.  When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice.  The following
special preparation is required for the fourth copy.

          Remove the "Supplemental Statement of Data
          Confidentiality Claims".

          Remove the "Confidential Attachment".

          Excise from the body of the study any information you
          claim as confidential, even if it does not fall within
          the scope of FIFRA §10(d)(1)(A), (B), or  (C).  Do not
          close up or paraphrase text remaining after this
          excision.

          Mark the fourth copy plainly on both its cover and its
          title page with the phrase "Public Docket Material -
          contains no information claimed as confidential".
V.
 For Further Information
     For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division,  (703) 305-5240.
                        «m«s W.  Aktrmin
                       Actins Dirtotoe,
Attachment 1,
Attachment 2,
Attachment 3.
Attachment 4.

Attachment 5,
Attachment 6,
Attachment 7
          Sample Transmittal Document
          Sample Title Page for a Newly Submitted Study
          Statements of Data Confidentiality Claims
          Supplemental Statement of Data Confidentiality
          Claims
          Samples of Confidential -Attachments
          Sample Good Laboratory Practice Statements
          Format Diagrams for Submittal Packages and Studies
                                180
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                          ATTACHMENT  1

       ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*

 1.   Name and  address of  submitter  (or  all  joint  submitters**)

 +Smith Chemical Corporation               Jones  Chemical  Company
 1234 West Smith  Street        -and-       5678 Wilson  Blvd
 Cincinnati, OH 98765          '           Covington, KY 56789


     ,  ,*
 +Smith Chemical Corp will act  as sole agent for all submitters.

 2.   Regulatory action in support of which  this package  is
     submitted

 Use the EPA identification number  (e.g. 359-EUP-67) if you know
 it.  Otherwise describe the type of request  (e.g. experimental
 use permit, data,call-in  - of  xx-xx-xx  date).

 3.   Transmittal  date

 4.   List of submitted studies

     Vol 1.    Administrative materials - forms, previous corres-
               pondence with Project Managers, and so forth.

     Vol 2.    Title of first  study in  the submittal  (Guideline
               No.)

     Vol n     Title of nth study in the  submittal (Guideline
               No.)

     *    Applicants commonly provide this information in a tran-
          smittal letter.  This remains an acceptable practice so
          long as all four elements are included.

     *    Indicate which of the joint submitters is empowered to
          act on behalf of all joint submitters in any matter
          concerning data compensation or subsequent use or
          release of the data.
Company Official:,
                   "' Name                Signature

Company Name :	
Company Contact:  	   	
                    Name                Phone
                               181
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                    ATTACHMENT 2

 SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY

                     Study Title

    (Chemical name)  - Magnitude  of Residue on  Corn

                  Data Requirement

                   Guideline 171-4

$                      Author

                    John C. Davis

                 Study Completed On

                   January 5,  1979

                Performing Laboratory

            ABC Agricultural Laboratories
                 940 West  Bay Drive
                Wilmington, CA  39897

                Laboratory Pro*! ect ID

                      ABC 47-79
                     Page 1 of X
    (X is  the  total  number of pages in the study)

                         182
-------
                           ATTACHMENT 3

             STATEMENTS OF DATA CONFIDENTIALITY CLAIMS

 1.  No claim of confidentiality under FIFRA §10(d)(1)(A),(B),  or
 (C) .

        STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
  No  claim of  confidentiality is made for any information
  contained in this  study on the basis of its falling within
  the scope of FIFRA 6§10(d)(1)(A),  (B),  or (C).
   Company
   Company Agent:

         Title
Typed Name
Date:
                     Signature
2. Claim of confidentiality under  FIFRA §10 (d) (1) (A)-,  (B) ,  or
 (C) .

             STATEMENT OF DATA CONFIDENTIALITY CLAIMS
  Information claimed confidential  on  the basis  of  its  falling
  within the scope of FIFRA  §10(d)(1)(A),  (B), or (C) has  been
  removed to a confidential  appendix,  and is  cited  by
  cross-reference number  in  the body of  the study.
  Company:
  Company Agent:

         Title
Typed Name
Date:
                     Signature
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request, for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the .analytical method.  'These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality.waiver before they can
be processed.
                               183
-------
                          ATTACHMENT 4

      SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
     For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A),  (B), or  (C), but for which you claim
confidential treatment on another basis, the following informa-
tion ,must be included within a Supplemental Statement of Data
Confidentiality Claims:

     •    Identify specifically by.page and line number(s) each
          portion of the study for which you claim
          confidentiality.

     •    Cite the reasons why the cited passage qualifies for
          confidential treatment.

     •    Indicate the length of time--until a specific date or
          event, or permanently--for which the information should
          be treated as confidential.

     •    Identify the measures taken to guard against undesired
          disclosure of this information.

     •    Describe the extent to which the information has been
          disclosed, and what precautions have been taken in con-
          nection with those disclosures.

     •    Enclose copies of any pertinent determinations of
          confidentiality made by EPA, other Federal agencies, of
          courts -concerning this information.

     •    If you assert that disclosure of this information would
          be likely to result in substantial harmful effects to
          you, describe those harmful effects and explain why
          they should be viewed as substantial.

     •    If you assert that the information in voluntarily sub-
          mitted, indicate whether you believe disclosure of this
          information might tend to lessen the availability to
          EPA of similar information in the future, and if so,
          how.
                                184
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                               ATTACHMENT  5

             EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS

Example  1.  (Confidential  word  or phrase that has been deleted
from the study)
   CROSS REFERENCE NUMBER 1.  This cross  reference number is used in the study
                             in place of the following words or phrase at the
                             indicated volume and page references.
   DELETED WORDS OR PHRASE:.
                                         •R<-Viy1 Q-no
      6
     12
    100
            LINE  REASON FOR THE DELETION
14
25
19
Identity of Inert  Ingredient
FIFRA REFERENCE

§10 (d) (1) (C)
Example 2.  (Confidential paragraph(s)  that have been deleted from the study)
  CROSS REFERENCE NUMBER 5. This  cross reference number is used in the study
                           in place of the following paragraph(s)•at the
                           indicated volume and page references.
   DELETED PARAGRAPH(S):
            Reproduce the  deleted paragraph(s) here
                                                           )
 PAGE       LINES REASON FOR THE DELETION                   FIFRA REFERENCE

  20.       2-17  Description of the quality control process   §10(d)(1)(C)
Example 3.  (Confidential pages that have been deleted from the study)
 CROSS REFERENCE NUMBER 2 This cross reference number noted on a place-
                         holder page is used in place of the following
                         whole pages at the indicated volume and page
                         references.

  DELETED PAGE(S):   are attached immediately behind this page.

  PAGE LINES      REASON FOR THE DELETION                   FIFRA REFERENCE

  20.  2-17 Description of the product manufacturing process   §10(d)(1)(A)
                                     185
-------
                                ATTACHMENT  6.
                  SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
     This study meets the requirements for 40 CFR Part 160
           Submitter •	
           Sponsor   	
           Study Director
Example 2.
    This study does not meet the requirements of 40 CFR Part 160,  and differs
    in the following ways:
    X.	[	2	
    2.	
    3.                                            	
          Submitter_
          Sponsor	
          Study Director_
Example 3.
    The submitter of this  study was  neither  the  sponsor of  this  study nor
    conducted  it,  and, does not  know whether ;it has  been conducted  in
    accordance with 40 CFR Part 160.
          Submitter
                                      186
-------
                          ATTACHMENT 7.
                   FORMAT OF THE SUBMITTAL PACKAGE
LEGEND
                    Transmittal Document.

                        Related Administrative Materials
                        te.g., Method of Support statement,  etc.)


                              Other materials about  the  submittal
                              Ifl'2:-rt """""J*8 of groups of  studies
                              to aid in their review).

                                     Studies, submitted  a» unique
                                     physical entities,  according
                                     to the  format below.
                   FORMAT Of SUBMITTED STUDIES
                   ^^^••MM^^^PVMMHM^^^


            Study title page.


                Statement of Confidentiality Claims.


                    GLP and flagging* statements - as appropriate.

                         Body of the study, with English
                         language translation if required.
             1--T
                             Appendices to the study.
                                .Title Page of the Confidential
                                 Attachment.
                                      Confidential Attachment.
                                          Supplemental Statement
                                          of Confidentiality Claims,

                                      *  When flagging requirements
                                        are finalised.
                Documents which must be  submitted as
                appropriate to meet established requirements.

                     Documents submitted at  submitter's option.
                           187
-------
188
-------
PR Notice  91-2
      189
-------
190
-------
               UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                             WASHINGTON, D.C.  20460
                                                           OFFICE OF
                                                         PREVENTION, PESTICIDES
                                                         AND TOXIC SUBSTANCES
                          PR NOTICE 91-2

         NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
                  AND  REGISTRANTS OF  PESTICIDES

ATTENTION:  Persons  Responsible  for Federal Registration of
Pesticide Products.

SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement

I. PURPOSE:

     The purpose of this  notice is to clarify the Office  of
Pesticide Program's policy  with respect to the statement  of
percentages in a pesticide's label's  ingredient statement.
Specifically, the amount  (percent by  weight)  of ingredient(s)
specified in the ingredient statement on the  label must be stated
as the nominal concentration of such  ingredient(s),  as that term
is defined  in 40 CFR 158.153 (i) .  Accordingly,  the Agency  has
established the nominal concentration as the  only acceptable
label claim for the amount  of active  ingredient in the product.

II. BACKGROUND

     For_some time  the Agency has accepted two different  methods
of identifying on the  label what  percentage is claimed for the
ingredient(s) contained in  a pesticide.  Some  applicants claimed  a
percentage which represented a  level  between  the upper and the
lower certified limits. This was  referred to  as the  nominal
concentration. Other applicants claimed the lower limit as  the
percentage of the ingredient(s) that  would be  expected to be
present in their product  at the end of  the product's shelf-life.
Unfortunately, this led to  a great  deal of confusion among  the
regulated industry, the regulators, and the consumers as  to
exactly how much of a given ingredient  was in  a given product.
The Agency has established  the  nominal  concentration as the only
acceptable label claim for  the  amount of active ingredient  in  the
product.

     Current regulations  require  that the  percentage listed in
the active ingredient statement be  as precise  as possible
reflecting good manufacturing practices  40  CFR 156.10(g)(5). The
certified limits required for each  active  ingredient are  intended
to encompass any such  "good manufacturing  practice"  variations 40

                                191
-------
CFR 158.175(c)(3).

     The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the •
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.

     The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product! composition because the nominal concentration would be
the amount of active ingredient typically found in the product.

     It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).

III. REQUIREMENTS

     As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition,  the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.

     The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.

     After July 1,\997, all pesticide ingredient Statements must
be changed to nominal concentration.
                                192
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA

     All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
     i i,*
     in those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.

V. COMPLIANCE SCHEDULE

     As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B).  Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:

     (1)   Beginning July 1, 1991,  all  new product registrations
          submitted to the Agency are  to comply with the
          requirements of this Notice.

     (2)   Registrants having products  subject to reregistration
          under FIFRA section 4(a)  are to comply with the
          requirements of this Notice  when specific products are
          called in by the Agency under Phase V of the
          Reregistration Program.
                               193
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      (3)  All other products/applications that are not subject to
           (1) and  (2)  above  will  have until July 1,  1997, to
          comply with  this Notice.  Such applications should note
          "Conversion  to Nominal  Concentrations on the
          application  form.  These types Or amendments will not be
          handled  as "Fast Track" applications but will be
          handled  as routine requests.

VI. FOIL FURTHER INFORMATION

Contact Tyrone Aiken for information or questions concerning
this notice on  (703) 308-7031.
                                              J.O   __/f ,

                                         •*—• si - f*-.-S^j- _j*t
                                       E. tdndaay,  Director
                                               Division (H-7505
                                194
-------
APPENDIX F.  Generic Data Call-in
               195
-------
196
-------
                          GENERIC DATA CALL-IN NOTICE
 CERTIFIED MAIL
Dear Sir or Madam:
This  Notice  requires you  and other registrants of pesticide products containing  the  active
ingredient(s)  identified in Attachment 1 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(s).  Within 90 days  after you receive this Notice you must
respond as set forth in Section III below. Your response must state:

1.     how you will comply with the requirements set forth in this Notice and its Attachments
       1 through 4; or,

2.     why you believe you are exempt from  the requirements listed in this Notice and hi
       Attachment 3, Requirements Status and Registrant's Response Form, (see section IH-B);
       or,

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

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice  will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-in Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 4).

       The authority for this Notice is section 3(c)(2)(B) of. the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).  Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107

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(expiration date 12-31-92).

    This Notice is divided into six sections and five 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 n     -      Data Required By This Notice
       Section III    -      Compliance With Requirements Of This Notice
       Section IV    -      Consequences Of Failure To Comply With This Notice
       Section V     -      Registrants' Obligation To Report Possible Unreasonable
                          Adverse Effects
       Section VI    -      Inquiries And Responses To This Notice

    The Attachments to this Notice are:

       Attachment 1 -      Data Call-In Chemical Status  Sheet
       Attachment 2 -      Data Call-In Response Form
       Attachment 3 -      Requirements Status And Registrant's Response Form
       Attachment 4 -      List Of All Registrants Sent This Data Call-In Notice
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed  to  support continued  registration of the  subject active  ingredient(s).   This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s).  You have been sent this Notice because you
have product(s) containing the subject active ingredient(s).

SECTION II. DATA REQUIRED BY THIS NOTICE

       A.    DATA REQUIRED

             The data required by  this Notice are specified hi Attachment 3, Requirements
       Status and Registrant's Response Form.  Depending on the results of the studies required
       hi this Notice,  additional testing may be required.

       B.    SCHEDULE FOR SUBMISSION OF DATA

             You are required to submit the data or otherwise satisfy the  data requirements
       specified in Attachment 3, Requirements Status and Registrant's Response Form, within
       the time frames provided.

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       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.
         i!>
              These  EPA  Guidelines are available from the National Technical Information
       Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel-
       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 hi 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, 1750  Pennsylvania  Avenue N.W.,
       Washington, D.C. 2Q006.

             All new studies and proposed protocols submitted hi response to this Data Call-In
       Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)] .
       D.    REGISTRANTS  RECEIVING PREVIOUS  SECTION 3fc)(2)rm NOTICES
             ISSUED BY  THE AGENCY

             Unless otherwise noted herein, this Data Call-In does not hi any way supersede
       or change the requirements of any previous Data Call-Intel,  or any other agreements
       entered into with the Agency pertaining to such prior Notice.  Registrants must comply
       with the requirements of all Notices to avoid issuance of a Notice  of Intent to Suspend
       their affected products.
SECTION HI.       COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

      A.     SCHEDULE FOR RESPONDING TO THE AGENCY

             The appropriate responses initially required by this Notice 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


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of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-
B.

       B.     OPTIONS FOR RESPONDING TO THE AGENCY

       The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s),  (3) claim generic data  exemption,  (4)  agree  to satisfy the data requirements
.imposed by this Notice or (5) request a data waiver(s).

       A discussion of how to respond if you chose 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 data requirements of this
Notice is contained hi Section III-C. A discussion of options relating to requests for data
waivers is contained hi Section O-D.

       There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response  to the Agency.  These forms are
the  Data-Call-in Response Form (Attachment 2)  and the Requirements Status and
Registrant's Response Form (Attachment 3). The Data Call-In Response Form must be
submitted as part of every response  to this Notice.  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 identified hi
Attachment 1.

        1.     Voluntary Cancellation - You may avoid the requirements of this Notice
       by requesting voluntary cancellation of your product(s) containing the active
       ingredients) 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 the Data Call-In Response  Form. If you choose this option, this is the only
       form that you are required to complete.

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

       2.     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, a completed application for amendment,

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 a copy of your proposed amended labeling, and all other information required for
 processing the application. Use deletion is option number 7 on the Requirements
 Status and Registrant's Response Form. 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 and
 Emergency Response Branch, Registration Division, (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, must bear an amended label.


 3.     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(s) if the active higredient(s)
 in the product is derived exclusively from purchased,  registered pesticide products
 containing the active ingredient(s).   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:

       a.     The active ingredient(s) hi your registered product must be present
       solely  because of incorporation of  another registered product which
       contains the subject active ingredient(s)  and  is purchased from a source
       not connected with you;  and,

       b.     every registrant  who  is  the ultimate  source  of the active
       ingredients) in your product subject  to this DCI must be in compliance
       with the requirements of this Notice and must remain in compliance; and

       c.      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 product specific data.

       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

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       appropriate steps to meet the requirements or are no longer in compliance with
       this Data Call-In Notice, the Agency will consider that both they and you are not
       in 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.

,  ,\    4.    Satisfying the Data Requirements of this Notice -  There  are various
       options available to satisfy the data requirements of this Notice.  These options
       are discussed in Section ffl-C of this Notice and comprise options 1 through 6 on
       the Requirements Status and Registrant's Response Form and option 6b and 7 on
       the Data Call-In Response Form.  If you choose option 6b or 7, you must submit
       both forms as well  as any other information/data pertaining to the option chosen
       to address the data  requirement.

       5.    Request  for Data Waivers.  Data waivers are discussed in Section III-D
       of this Notice and are covered by options 8 and 9 on 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.

C.     SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), 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 hi 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),
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 5.     I am submitting or citing data, to upgrade a study classified by EPA as
       partially acceptable and upgradeable (Upgrading a Study),

 6.     I am citing an existing study that EPA has classified as acceptable or an
       existing study that has been submitted but not reviewed  by the Agency
       (Citing an Existing Study).

 Option 1. Developing Data —

       If you choose to develop the required data it must be hi conformance with
 Agency deadlines and with other Agency requirements as referenced herein and
 in the attachments.  All data generated and submitted must comply with the Good
 Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
 Pesticide  Assessment  Guidelines  (PAG), and  be in conformance  with the
 requirements of PR Notice 86-5.  In addition, certain studies require Agency
 approval of test protocols in advance of study initiation. Those studies for which
 a protocol must be submitted have been identified in the Requirements Status and
 Registrant's Response Form and/or footnotes to the form.  If you wish to use a
 protocol which differs from the options discussed in Section II-C  of this Notice,
 you must submit a detailed description of the proposed protocol and your reason
 for wishing to use it.  The Agency may choose to reject a protocol not specified
 in Section II-C.  If the Agency rejects your  protocol you will  be notified in
 writing, however, you should be aware that rejection of a proposed protocol will
 not be a basis for extending the deadline for submission of data.

       A progress report must be submitted for each study within 90 days from
 the date you are required to commit to generate or undertake some other means
 to address that  study requirement, such as making  an offer to cost-share or
 agreeing to share in the cost of developing that study.  A 90-day progress report
 must be submitted for all studies. This 90-day progress report must include the
 date the study was or will be initiated and, for studies to be started within 12
 months of commitment, the name and address of the laboratory(ies) or individuals
 who are or will be conducting the study.

       In addition, if the time frame for submission of a final report is more than
 1 year, interim reports must be submitted at 12 month intervals from the date you
 are required to commit to  generate or otherwise address the requirement for the
 study. In addition to the other information specified hi the preceding paragraph,
 at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.

       The time frames in the Requirements Status and Registrant's Response
Form are the time  frames that the Agency is allowing for the  submission of

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completed study reports or protocols.  The noted deadlines run from the date of
the receipt of this Notice by the registrant.  If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).

       If you cannot submit the data/reports to the Agency hi the tune required
by this Notice and intend to seek additional tune to meet the requirement(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 hi writing.  If EPA
does not grant your request, the original deadline remains.  Normally, extensions
can be requested only  hi cases  of extraordinary testing problems beyond the
expectation  or control of the registrant.   Extensions will not be given in
submitting the 90-day responses.  Extensions will not be considered if the request
for extension is not made hi a timely fashion; hi 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 hi the cost of producing
the required data but will not be submitting the data yourself, you must provide
the name  of the registrant who will  be submitting the data.  You must also
provide EPA with documentary evidence that an agreement has  been  formed.
Such evidence may be  your letter offering to join hi 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 then: differences through binding arbitration.

Option 3.  Offer to Share in the Cost of Data Development —

       If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the  requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting  this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with
the data submission requirements of this Notice. EPA has determined that as a
general policy,  absent other relevant considerations,  it will not suspend the
registration  of a product of a registrant who has hi good faith  sought and
continues to seek to enter into a joint data development/cost sharing program, but

                             204
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the other registrant(s) developing the data has refused to accept your offer.  To
qualify for this option, you must submit documentation to the Agency proving
that you have made an offer to another registrant (who has an obligation to submit
data) to share hi 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.  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 or failing agreement to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this
offer.  The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-In
Response  Form and a Requirements Status and  Registrant's Response  Form
committing to develop and submit the data required by this Notice.

       In order for you to  avoid suspension  under this option,  you may not
withdraw your offer to share hi the burdens 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 will normally be subject to initiation of suspension proceedings,
unless you commit to submit, and do submit the required data  hi the specified
time frame. In such cases, the Agency generally will not grant a time extension
for submitting the data.

Option 4. Submitting an Existing Study —

       If you choose to submit an existing study hi response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has  not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate
issuance of this Notice.  Do not use this option if you are submitting data to
upgrade a study. (See Option 5).

       You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required  date of submission.  The Agency may
determine at any time that a study is not valid and needs to be repeated.

       To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
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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 hi accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7) " raw
data means any laboratory worksheets, records, memoranda,  notes, or
exact copies thereof, that  are the  result of original observations and
activities  of a  study  and are necessary  for the reconstruction  and
evaluation of the report of that study.   In the event that exact transcripts
of raw data have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified  accurate  by signature), the exact copy or
exact transcript may be substituted  for the original source as raw  data.
Raw data  may  include photographs,   microfilm or microfiche copies,
computer printouts, magnetic media, including dictated observations, and
recorded data from automated instruments."   The term  "specimens",
according to 40 CFR 160.3(7), means  "any material derived from a test
system for examination or analysis."

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

c.     You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the  study  provided hi 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, hi 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  are usually not available  for  such
studies.
                      206
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              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 hi the
       final protocol and study.

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

Option 5. Upgrading a Study —

       If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that  study.  The Agency will  review the data
submitted and  determine if the requirement is satisfied.  If the Agency decides the
requirement is not  satisfied, you may still  be required to  submit new data
normally without any tune 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
MRID 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 should also be  used to cite data that has  been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency.  You
must provide the  MRID number of the data submission as well as the MRID
number of the study  being upgraded.

       The criteria for  submitting an existing study, as  specified in Option 4

                            207
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      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 —

  tv           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.

D.    REQUESTS FOR DATA WAIVERS

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

       1.      Low Volume/Minor Use Waiver - Option  8 nn 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 as  low  volume
       pesticides  only those  active ingredient(s) whose total production volume for all
       pesticide registrants is small. In  determining whether to grant a low  volume,
       minor use  waiver the Agency will consider the extent, pattern and volume of use,
       the economic incentive to conduct the testing, the importance of the pesticide, and
       the exposure and risk from use of the pesticide.  If an active ingredient(s) 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(s) 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(s) elects  to conduct the testing.  Any
       registrant  receiving a low volume minor use waiver must remain within  the sales
       figures in  their forecast supporting the waiver request in order to remain qualified

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for such waiver.  If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports.   The  Agency will respond to
requests for waivers in writing.

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

       a.      Total  company sales (pounds and dollars)  of  all  registered
       product(s) containing the  active ingredient(s). If applicable to the active
       ingredient(s),  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.

       b.      Provide an estimate of the sales (pounds  and dollars) of the active
       higredient(s) for each major use site.  Present the above information by
       year for each of the past five years.

       c.      Total  direct production cost of product(s) containing the active
       ingredient(s) 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.

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

       e.      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.

       f.      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.

       g.      For each of the next ten years, a year-by-year forecast of company
       sales (pounds and dollars) of the active ingredients), direct production
       costs of product(s) containing the active ingredient(s) (following the
       parameters  in item c  above),'indirect production costs of product(s)

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              containing the active ingredient(s) (following the parameters in item d
              above),  and  costs  of  data  development  pertaining  to  the  active
              ingredient(s).

              h.     A description of the importance and unique benefits of the active
              ingredient(s) to users.  Discuss the use patterns and the effectiveness of
              the  active ingredient(s) relative to registered alternative chemicals and
,  ,\           non-chemical control strategies.  Focus on benefits unique to the active
              ingredient(s), providing information that is as quantitative as possible.  If
              you do not have quantitative data upon which to base your estimates, then
              present the reasoning used to derive your estimates. To assist the Agency
              hi determining the degree  of importance of the active ingredient(s) in
              terms of its benefits,  you should provide  information  on any of  the
              following factors, as applicable to your product(s):

                    (1)    documentation of the usefulness of the active ingredient(s)
              in Integrated Pest Management, (b) description of the  beneficial impacts
              on the environment of use  of the active ingredient(s), as opposed  to its
              registered alternatives,  (c)  information on the breakdown of the active
              ingredient(s) after use and on its persistence in the environment, and  (d)
              description of its usefulness  against a pest(s) of public health significance.

       Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result hi denial of the request
for a waiver.

       2.     Request for Waiver of Data —Option 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 corresponding use is no
       longer registered or  the requirement is inappropriate.   You must  submit a
       rationale explaining why you  believe the data requirements  should not apply.
       You  must also 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 do not  apply to  your
       produces),  you will  not be required to supply the data  pursuant to section
       3(c)(2)(B).  If EPA determines that the data are required for your productCs"). 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.
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IV.    CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
                         i,                         \
       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
       ,iss,uance of a Notice of Intent to Suspend include, but are not limited to, the following:

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

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

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

             4.     Failure to submit on the required schedule acceptable data as required by
                    this Notice.

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

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

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

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

                    a.     inform EPA of intent to develop and submit  the data required by
                    this Notice on a Data Call-in Response Form and a  Requirements Status
                    and Registrant's Response Form: or,

                    b.     fulfill the commitment to develop and submit the data as required

                                         211
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             by this Notice; or,

             c.     otherwise take appropriate steps to meet the requirements stated in
             this Notice, unless you commit to submit and do submit the required data
             hi the specified time frame.

       9.     Failure to take any required or appropriate steps, not mentioned above, at
  ,i    any time following the issuance of this Notice.
B.     BASIS  FOR  DETERMINATION  THAT   SUBMITTED   STUDY   IS
       UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to
Suspend. The grounds for suspension include, but are not limited to, failure to meet any
of the following:

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

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

       3.     EPA requirements regarding the reporting of data, including the manner
       of reporting,  the  completeness of results, and the adequacy of any required
       supporting (or raw) data, including, but not limited to,  requirements referenced
       or included in this Notice or contained in PR 86-5.  All studies must be submitted
       in the form of a final report; a preliminary report will.not be considered to fulfill
       the submission requirement.
                  •3u                 '          ''
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  Federal  Insecticide, Fungicide,  and
Rodenticide Act.	
                                   212
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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 would
      generally 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 must also 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 hi full compliance with all Agency requirements, you will
      have, under most  circumstances, one year from the date your 90 day response to this
      Notice is due, to sell, distribute, or use existing stocks.  Normally, the Agency will allow
      persons other than the registrant such as independent distributors, retailers and end users
      to sell, distribute or use  such existing stocks until the stocks are exhausted.  Any sale,
      distribution or use  of stocks of voluntarily cancelled products containing an active
      ingredient(s) for which the Agency has particular risk concerns will be determined on
      case-by-case basis.

             Requests for voluntary cancellation  received after the 90 day response period
      required by this Notice will not result hi the Agency granting any additional tune 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
                        i&                           >'
      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 me environment. This requirement continues as long
as the products are registered by the Agency.

                                          213
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SECTION VI.       INQUIRIES AND RESPONSES TO THIS NOTICE

      If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person listed hi Attachment 1, the Data Call-In Chemical Status Sheet.

      All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Attachment 2) and
a completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice,  and should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.

      The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated hi response to this Notice.

                                              Sincerely yours,
                                              Daniel M. Barolo, Director
                                              Special Review
                                               and Reregistration Division
                                         214
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Attachment 1. Chemical Status Sheet
                215
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216
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Mineral Acids DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You  have been sent this Generic Data  Callln Notice because you have product(s)
containing mineral acids.

       Thijs Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of mineral acids.
This attachment is to be used hi conjunction with (1) the Generic Data Call-In Notice, (2) the
Generic Data Call-In Response Form (Attachment  B),  (3)  the Requirements  Status  and
Registrant's Form (Attachment C), (4) a list of registrants receiving this DCI (Attachment D),
(5) the EPA Acceptance Criteria (Attachment E), and (6) the Cost Share and Data Compensation
Forms hi replying to this mineral acids Generic Data Call-In (Attachment F).  Instructions and
guidance accompany each form.

DATA REQUIRED BY THIS NOTICE
       The additional data requirements needed to complete the generic database  for mineral
acids are contained in the Requirements Status and Registrant's Response. Attachment C. The
Agency has concluded that additional product chemistry data on mineral acids are needed.  These
data are needed to fully complete the reregistration of all eligible mineral acids products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any  questions regarding the generic data requirements and procedures
established by this Notice, please contact Kathryn Scanlon at (703) 308-8178.
       All responses to this  Notice for the generic data requirements should be submitted to:

             Kathryn Scanlon, Chemical  Review Manager
             Accelerated Reregistration Branch
             Special Review and Registration Division (H7508W)
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C.  20460
             RE: Mineral Acids
                                        217
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218
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Attachment 2. Generic DCI Response Forms Inserts (Form
                 A) plus Instructions
                         219
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220
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM

       This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide  Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."

       ftejms  1-4 will have been preprinted on the form Items 5 through 7 must be completed
       by the registrant as appropriate Items 8 through 11 must be completed by the registrant
       before submitting a response to the Agency.

       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 suggesting for reducing this burden,  to Chief, Information Policy
Branch, PM-223, 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

       Item 1.       This item identifies your company name, number and address.

       Item 2.       This item identifies the ease number, ease name, EPA chemical  number
                    and chemical name.

       Item 3.       This item identifies the date and type of data call-in.

       Item 4.       This item identifies the EPA product registrations relevant to the data
                    call-in.  Please note that  you  are also responsible  for informing the
                    Agency of your response regarding any product that you believe  may be
                    covered by this data call-in but that is not listed by the Agency in Item 4.
                    You must bring any such  apparent omission to the Agency's attention
                    within the period required for submission of this response form.

       Item 5.        Cheek 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.  You do not need to complete any item on the Requirements
                    Status and Registrant's Response Form for any product that is voluntarily
                    cancelled.
                                         221
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Item 6a.      Check this item if this data call-in is for generic data as indicated in Item
              3 and if 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 hi the Data Call-In Notice.

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

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

Item 6b.      Check this Item if the data call-in is a generic data call-in 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.

Item 7a.      Check this item if this call-in  if a data call-in as indicated in Item 3 for a
              manufacturing use product (MUP), and if your product is a manufacturing
              use product for which you agree to supply product-specific data. Attach
              the Requirements Status and  Registrants' Response Form that indicates
              how  you will satisfy  those requirements.

Item 7b.      Check  this item if this  call-in is a data call-in for an end use product
              (EUP) as indicated hi Item 3 and if your product is an end use product for
              which you agree to supply product-specific data. Attach the Requirements
              Status and Registrant's Response Form that indicates how you will satisfy
              those requirements.

Item 8.       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 hi your response must be initialled and dated in the
              space provided  for the certification.

Item 9.       Enter the date of signature.
                                   222
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Item 10.      Enter the name of the person EPA should contact with questions regarding
             your response.

Item 11.      Enter the phone number of your company contact.
                                 223
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Attachment 3. Requirements Status and Registrants'
 Response Forms Inserts (Form B) plus Instructions
                       224
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 SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
 REGISTRANTS RESPONSE FORM

 Generic Data

 This form  is  designed  to be used for registrants to respond  to  call-in- for generic  and
 product-specific data as  part of EPA's reregistration  program under the Federal  Insecticide
 Fungicide^and Rodenticide Act. Although the form is the same for both product specific and
 generic data, instructions for completing the forms differ slightly.  Specifically, options for
 satisfying product specific data requirements do not include (1) deletion of uses or (2) request
 for a low volume/minor use waiver.   These instructions are for completion of generic data
 requirements.

 EPA has developed this form individually for each data call-in addressed to each registrant,  and
 has preprinted this form with a number of items. DO NOT use this form for any other active
 ingredient.

 Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all
 other items on this form by typing or printing legibly.

 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 suggesting for reducing this burden, to Chief, Information Policy Branch,
 PM-223, 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 2070-010?'
 Washington,  D.C. 20503.

 INSTRUCTIONS

 Item 1.        This item identifies your company name, number, and address.

 Item 2.        This item identifies the case number, case name, EPA chemical number and
             chemical name.                  .

 Item 3.       This item identifies the date and type  of data call-in.

 Item 4.       This item identifies the guideline reference numbers of studies required to support
             the  product(s) being reregistered. These guidelines,  in addition to requirements
             specified hi the Data Call-In Notice, govern the conduct of the required  studies.

Item 5.       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

                                        225
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Item 6.,
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.

This item identifies the code associated with  the use pattern of the pesticide. A
brief description of each code follows:
                    A.
                    B.
                    C.
                    D.
                    E.
                    F.
                    G.
                    H.
                    I.
                    J.
                    K.
                    L.
                    M.
                    N.
                    O.
                          Terrestrial food
                          Terrestrial feed
                          Terrestrial non-food
                          Aquatic food
                          Aquatic non-food outdoor
                          Aquatic non-food industrial
                          Aquatic non-food residential
                          Greenhouse food
                          Greenhouse non-food crop
                          Forestry
                          Residential
                          Indoor food
                          Indoor non-food
                          Indoor medical
                          Indoor residential
Item 7.
This item identifies the code assigned to the substance that must be used for
testing.  A brief description of each code follows.
                    EP
                    MP
                    MP/TGAI

                    PAI
                    PAI/M
                    PAI/PAIRA
                         %
                    PAIRA
                    PAIRA/M
                    PAIRA/PM

                    TEP
                    TEP  *
                          End-Use Product
                          Manufacturing-Use Product
                          Manufacturing-Use Product and Technical Grade
                          Active Ingredient
                          Pure Active Ingredient
                          Pure Active.Ingredient and Metabolites
                          Pure Active Ingredient or Pure Active Ingredient
                          Radiolabelled-
                          Pure Active Ingredient Radiolabelled
                          Pure Active IngredientRadiolabelled and Metabolites
                          Pure Active Ingredient Radiolabelled and Plant
                          Metabolites
                          Typical End-Use Product
                          Typical End-Use Product, Percent Active Ingredient
                          Specified
                                         226
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                    TEP/MET           Typical End-Use Product and Metabolites
                    TEP/PAI/M         Typical End-Use Product or Pure Active Ingredient
                                        and Metabolites
                    TGAI/PAIRA       Technical Grade Active Ingredient or Pure Active
                                        Ingredient Radiolabelled
                    TGAI               Technical Grade Active Ingredient
                    TGAI/TEP          Technical  Grade Active  Ingredient  or Typical
      ,  f                               End-Use Product
                    TGAI/PAI           Technical Grade Active Ingredient or Pure Active
                                        Ingredient
                    MET               Metabolites
                    IMP                Impurities
                    DEGR              Degradates

      *See: guideline comment

Item 8.       This item  identifies the tune frame allowed for submission of the study or
             protocol identified in item 2. The time frame runs from the date of your receipt
             of the Data Call-In Notice.

Item 9.       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.

             1.     (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  protocol and progress
                    reports required hi item 5 above.

             2.     (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.                                           .
                        •"£                          *             .
             3.    (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 submitting  a copy of
                   the  form "Certification of Offer to Cost  Share hi the Development of
                   Data" that  describes  this offer/agreement.   By indicating that  I  have
                   chosen this  option, I certify that I will comply with all the requirements
                   pertaining to making an.offer to share in the cost of developing data as
                   outlined hi the Data Call-In Notice.

                                         227                .         -•
-------
              4.     (Submitting Existing Data) I am submitting an existing study that has
                     never before been submitted to EPA. By indicating that I have chosen this
                     option, I certify that this study meets all the requirements pertaining to the
                     conditions for submittal of  existing data  outlined in the  Data Call-In
                     Notice and I have attached the needed supporting information along with
                     this response.

       ,  ,v    5.     (Upgrading a Study) I am submitting or citing 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 hi the Data Call-In Notice.  I am
                     indicating  on  attached correspondence the Master Record  Identification
                     Number (MRID) that EPA has assigned to the data that I am citing as well
                     as the MRID of the study I am attempting  to upgrade.

              6.     (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. I am providing the Agency's
                     classification of the study.

              7.     (Deleting Uses)  I  am  attaching an application for amendment  to my
                     registration deleting the uses  for which the data are required.

              8.     (Low Volume/Minor Use  Waiver Request) I have read the statements
                     concerning low volume-minor use data waivers hi 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.

              9.     (Request for Waiver of Data) I have read the statements concerning data
                     waivers other than low volume minor-use data waivers  in the Data Call-in
                     Notice and I request a waiver of. the data requirement. I am attaching an
                     identification of the basis for this waiver and a detailed justification to
                     support this  waiver  request. The justification includes, 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.

Item 10.      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.


                                          228
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Item 11.      Enter the date of signature.

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

Item 13.      Enter the phone number of your company contact.
                                        229
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230
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Attachment 4. List of Registrants) sent this DCI (Insert)
                          231
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232
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APPENDIX G. Product Specific Data Call-In
                  233
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234
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                               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 1 of this Notice, the Data Call-In Chemical Status Sheet, to
 submit certain product specific data as  noted herein to the U.S.  Environmental Protection
 Agency (EPA, the Agency).  These data are necessary to maintain the continued registration of
 your product(s) containing this active ingredient. Within 90 days after you receive this Notice
 you must respond as set forth in Section III below.  Your response must state:

       1.     How you will comply with the  requirements set forth in this  Notice  and its
              Attachments A through G; or

       2.     Why you believe you are exempt from the requirements listed in this Notice and
              in  Attachment 3,   Requirements  Status and  Registrant's Response Form, (see
              section III-B); or

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

       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements  or should be exempt or excused from doing so, then the registration of
your produces) subject to this Notice will be subject to suspension.  We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-in Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 6).

       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B).  Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
                                         235
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    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 HI-  Compliance With Requirements Of This Notice
       Section IV -  Consequences Of Failure To Comply With This Notice
       Section V  -  Registrants' Obligation To Report Possible Unreasonable Adverse
                   Effects
       Section VI -  Inquiries And Responses To This Notice

    The Attachments to this Notice are:

       1  -   Data Call-In Chemical Status Sheet
       2 -   Product-Specific Data Call-In Response Form
       3  -   Requirements Status and Registrant's Response Form
       4 -   EPA  Grouping  of  End-Use  Products for Meeting Acute  Toxicology Data
             Requirements for Reregistration
       5 -   EPA Acceptance Criteria
       6 -   List of Registrants Receiving This Notice
       7 -   Cost Share and Data Compensation Forms, and Product Specific  Data Report
             Form
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

       The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient.  The Agency has
concluded that the only additional data necessary are product specific data.  No additional
generic data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.

SECTION H.  DATA REQUIRED BY THIS NOTICE

n-A. DATA REQUIRED

       The product  specific  data required by  this  Notice are specified  hi  Attachment 3,
Requirements Status  and Registrant's Response Form.  Depending on the  results of the studies
required hi this Notice, additional  testing may be required.

n-B. SCHEDULE FOR SUBMISSION OF DATA
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     You are required to submit the data or otherwise satisfy the data requirements specified in
 Attachment 3, Requirements Status  and Registrant's  Response Form,  within the time frames
 provided.


 H-C.  TESTING PROTOCOL

     All, Sadies 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 (tel: 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,  1750 Pennsylvania Avenue N W
 Washington, D.C. 20006.                                                            '  "

       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 160.3(a)(6)].

 n-D- REGISTRANTS RECEIVING PREVIOUS  SECTION 3(c)(2)fm NOTTCF.S
     ISSUED BY THE AGENCY

     Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the
 requirements of any previous Data Call-TnfsV or any other agreements entered into with the Agency
 pertaining to such prior Notice.  Registrants must comply  with the requirements of all Notices to
 avoid issuance of a Notice  of Intent to Suspend their affected products.

 SECTION III.  COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

 in-A.  SCHEDULE FOR RESPONDING TO THE AGENCY

       The appropriate responses initially required by this Notice for 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 hi Section IV-A and IV-B.
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m-B.  OPTIONS FOR RESPONDING TO THE AGENCY

       The options for responding to this Notice for product specific data are:  (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).

       A discussion of how to respond if you chose 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 IH-C.  A discussion of options relating to
requests for data waivers is contained hi Section ffl-D.

       There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used hi your response to the Agency.   These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. 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 must
be submitted for each product listed on the Data Call-In Response Form unless  the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form hi Attachment 2).  Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status  and  Registrant's Response Form  (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options.  Do not
alter the printed material.  If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.

       1.  Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your produces) containing the active ingredient that is the subject of 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 the Data Call-In Response Form. If you  choose this option, this is the only form 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 hi accordance with the Existing Stocks provisions
of this Notice which are contained hi Section IVrC.
       2. 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 ni-C of this Notice and comprise options 1  through 6 on the Requirements
 Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
 Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
 product specific data requirements.

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       3.  Request for  Product Specific Data Waivers.   Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on 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.

III-C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
       •  •.>
       If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 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 hi 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 - If you choose to  develop  the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments.  All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part  160),  be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.

       The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency  is allowing  for the submission of completed study reports.  The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).

       If you cannot submit the data/reports to the Agency hi the tune required by this Notice and
intend to seek additional time to meet the requirements^), you must submit a  request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule

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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 hi cases of extraordinary testing problems
beyond the expectation or control of the registrant.  Extensions will not be given in submitting the
90-day responses.  Extensions will not be considered if the request for extension is not made hi a
timely fashion; hi 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 ~ 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 hi
the agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement  to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data.  You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering  to join hi 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 - This option only applies to
acute toxicity and certain efficacy data as described in option 2 above.  If you have made an offer
to pay hi  an attempt to enter  hito an agreement or amend  an  existing agreement to  meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to  exercise its discretion not to suspend your registration^), 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 hi good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to  accept your offer.
To qualify for this option,  you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden
of developing that data.  You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share hi 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 hi the burden of producing the data upon terms to be agreed 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

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 develop and submit the data required by this Notice by submitting a Data Call-in Response Form
 and a Requirements Status and Registrant's Response Form committing to develop and submit the
 data required by this Notice.

       In order for you to avoid suspension under this option, you may not withdraw your offer
 to share in the burdens 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 devejon the data or for some other reason is subject to suspension, your registration as well as
 that of the other registrant will normally be subject to initiation of suspension proceedings, unless
 you commit to submit, and do submit the required data in the specified time frame. In such cases,
 the Agency generally will not grant a time extension for  submitting the data.

       Option 4. Submitting an Existing Study - If you choose to submit an existing study  in
 response to this Notice, you must determine that the study satisfies the requirements imposed by
 this  Notice. You may only submit a study that has not been previously submitted to the Agency
 or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
 Do not use this option if you are submitting data to upgrade a study. (See Option 5).

       You should  be aware that if  the Agency determines that the study is not acceptable, the
 Agency will require you to comply with this Notice,  normally without an extension of the required
 date of submission.  The Agency may determine, at any time that a study is not valid and needs  to
 be repeated.

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

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

      b.     Health and safety studies completed after May 1984 must also  contain all GLP-
             required  quality  assurance and  quality" control  information,  pursuant to  the

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             requirements of 40 CFR Part  160.  Registrants must also certify at the time of
             submitting the existing study that such GLP information is available  for post-May
             1984 studies by including an appropriate statement on or attached to the study signed
             by an authorized official or representative of the registrant.

       c.     You must certify that each study fulfills the acceptance criteria for the Guideline
             relevant to the study provided in the FIFRA Accelerated 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 are usually 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 you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does  contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study.  If such  study is in the Agency's files, you
need only cite  it along with the notification.  If not in the Agency's files, you must  submit a
summary and copies as required  by PR Notice 86-5.

       Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study.   The Agency  will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally.be classified, as supplemental.  However, it is
important to note that not all studies classified as supplemental are upgradeable.   If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA.  You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.              .                      , .   „„,	
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        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 should also be used to cite data that has been previously submitted to upgrade
 a study, but has not yet been reviewed by .the Agency.  You must provide the MRID number of
 the data submission as well as the MRID number of the study being upgraded.

       (The criteria for submitting an existing study, as specified in Option 4 above, apply to all
 data submissions intended to upgrade studies.  Additionally your submission of data intended to
 upgrade studies must be accompanied by a certification that you comply with each of those criteria
 as well as a certification regarding protocol compliance with Agency requirements.

       Option 6. Citing Existing Studies - If you choose to cite a study that has been previously
 submitted to EPA, that study must have been previously  classified by EPA as acceptable or it must
 be a study which has not yet  been reviewed by the  Agency.   Acceptable  toxicology studies
 generally will have  been classified  as "core-guideline" or  "core minimum."  For 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.                                                             "        	

       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, as appropriate.

 III-D  REQUESTS FOR DATA WATVF.KS

              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 hi support of your request  If the Agency
 ^Pp.^% 7°fCTwaiver re
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IV.  CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

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

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

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

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

       4.     Failure to submit on the required schedule acceptable data as required by this  Notice.

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

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

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

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

             a.      inform EPA of intent to develop and  submit the data required by this Notice
                    on a Data Call-in Response Form and a Requirements Status and Registrant's
                    Response Form:

             b.      fulfill the commitment to develop and submit the  data as required  by this
                    Notice; or

             c.      otherwise take appropriate step's to  meet the requirements  stated  in this

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                     Notice, unless you commit to submit and do submit the required data in the
                     specified time frame.

       9.     Failure to take any required or appropriate steps, not mentioned above, at any time
              following the issuance of this. Notice.

 IV-B.  BASIS FOR  DETERMINATION THAT SUBMITTED STUDY IS
 UNACCEPTABLE

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

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

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

IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

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

       The Agency has determined that such disposition by registrants  of existing stocks  for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes.   Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing  stocks of suspended  produces) only in exceptional
circumstances.  If you believe such disposition of existing stocks of your product(s) which may be
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
must also explain why an "existing stocks" provision' is "necessary, including a statement of  the

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quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use.  Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.

       If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will  have, under  most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks.  Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such 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 case-by-case basis.

       Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result hi the Agency granting any additional tune 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 tune after a
pesticide is registered a registrant has additional factual information regarding unreasonable adverse
effects on the environment  by  the pesticide,  the registrant shall submit the  information to the
Agency. Registrants must notify the Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary results of studies, regarding unreasonable
adverse effects on man or the environment. This requirement continues as long as the products are
registered by the Agency.

SECTION VI.  INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any questions regarding the requirements and procedures  established by this
Notice, call the contact person(s) listed  hi Attachment 1,  the Data Call-In Chemical Status Sheet.

       All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must  include a completed Data  Call-In Response  Form  and a  completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3  for product
specific data) and any  other documents required by this  Notice, and should be submitted to the
contact person(s) identified in Attachment. 1.  .If. the-  voluntary cancellation or generic  data
exemption option is chosen,  only the Data Call-In Response  Form need be submitted.
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       The Office of Compliance  Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS),. EPA, will be monitoring the data being generated in response to this Notice.
                                       Sincerely yours,
                                       Daniel M. Barolo, Director
                                       Special Review and
                                        Reregistration Division
Attachments

       1  -
       2  -
       3  -
       4  -

       5  -
       6  -
       7  -
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA  Grouping  of  End-Use  Products  for Meeting Acute Toxicology  Data
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Form
                                         247
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248
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Attachment 1. Chemical Status Sheet
               249
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MINERAL ACIDS DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-In Notice because you have
produces) containing mineral acids.

       This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
mineral acids.  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 B), (3) the
Requirements Status and Registrant's Form (Attachment C), .(4) EPA's Grouping of End[-]Use
Products for Meeting Acute Toxicology Data Requirement (Attachment D), (5) the EPA
Acceptance Criteria  (Attachment E), (6) a list of registrants receiving this DCI (Attachment F)
and (7) the Cost Share and Data Compensation Forms in replying to this mineral acids Product
Specific Data Call[-]In (Attachment G).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The additional data requirements needed to complete the database for mineral acids are
contained in the Requirements Status and Registrant's Response. Attachment C.  The Agency
has concluded that additional data on mineral acids 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 mineral acids products.

INQUIRIES AND RESPONSES TO THIS NOTICE

       If you have any  questions regarding the generic database of mineral acids, please contact
Kathryn Scanlon at (703) 308-8178.

       If you have any  questions regarding the product specific data requirements and
procedures established by this  Notice, please contact Frank Rubis (703) 308-8184
       All responses to this Notice for the Product Specific data requirements should be
       submitted to:
             Accelerated Reregistration Branch,  Chemical Review Manager Team 81
             Product Reregistration Branch
             Special Review  and Reregistration Branch 7508W
             Office of Pesticide Programs
             U.S. Environmental Protection Agency
             Washington, D.C.  20460

             RE: Mineral Acids
                                          250
-------
Attachment 2. Product Specific Data Call-In Response
      Forms (Form A inserts) Plus Instructions
                       251
-------
252
-------
INSTRUCTIONS  FOR COMPLETING THE  "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA

Item 1-4.     Already completed by EPA.

Item 5.      If you wish to voluntarily cancel your product, answer "yes".  If you choose this
             option, you will not have to provide the data required by the Data Call-In Notice and
             you will not have to complete any other forms. Further sale and distribution of your
       .  •}    product after the effective date of cancellation must be in accordance with  the
             Existing Stocks provision of the Data Call-In Notice (Section IV-C).

Item 6.      Not applicable since this form calls in product specific data only.  However, if your
             product is identical to another product and you qualify for a data exemption, you
             must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
             EPA reregistration numbers of your source (s);  you  would 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.

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

Item 7b.      For each end use product (EUP) for which you wish to maintain  registration, you
             must agree  to  satisfy  the data requirements by responding "yes."  if you are
             requesting a data waiver,  answer "yes"  here; hi 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.  See item
             6 with regard to identical products and data exemptions.

Items 8-11.   Self-explanatory.

       Note: You may provide additional information that does not fit on this form hi a signed letter
       that accompanies this form.  For  example, you may wish to report that your product has
       already been transferred to another 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.
                                          253
-------
254
-------
Attachment 3. Product Specific Requirement Status and
   Registrant's Response Forms (Form B inserts) and
                    Instructions
                        255
-------
256
-------
INSTRUCTIONS  FOR   COMPLETING  THE  "REQUIREMENTS   STATUS   AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA

Item 1-3.     Completed by EPA.  Note the unique identifier number assigned by EPA in item 3.
              This number must be used in the transmittal document for any data submissions in
              response to this Data Call-In Notice.

Item 4.       The guidelines reference numbers  of studies required to support the product's
       ,  .}.    continued  registration are  identified.   These  guidelines,  in  addition to  the
         ;     requirements specified in the 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.       The study title associated with the guideline reference number is identified.

Item 6.       The use patters (s) of the pesticide associated with the product specific requirements
              is (are) identified.  For most product specific data requirements, all use patterns are
              covered by the data requirements. In the case  of efficacy data, the required studies
              only pertain to products which have the use sites and/ or pests indicated.

Item 7.       The substance to be tested is identified by EPA. For product specific data,  the
              product as formulated for sale and distribution is  the test substance, except hi rare
              cases.

Item 8.       The due date for submission of each study is identified. It is normally based on 8
              months  after  issuance of the Reregistration  Eligibility Documents unless  EPA
              determines that a longer time period is necessary.

Item 9.       Enter Only one of the following response codes for each data requirement to show
              how you intend to comply with the data requirements listed  hi this table. Fuller
              descriptions of each option are contained in the Data Call-In Notice.

              1.    I will generate and submit data by the specified due date (Developing Data).
             By indicating that I have chosen this  option, I certify that I will comply with all the
             requirements pertaining to the conditions for submittal of this study as outlined hi
             the  Data Call-In Notice.

             2.    I have entered into an agreement with one or more registrants to develop data
             jointly (Cost Sharing).  I am submitting a copy  of this agreement. I understand that
             this option is available on  for acute toxicity or certain efficacy data and only if EPA
             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, my be .subject to suspension.

             3.     I have made offers  to share hi the cost to develop data (Offers to Cost Share).

                                          257
-------
 I understand that this option is available only for acute toxicity or certain efficacy
 data and only if EPA indicates in an attachment to this Data Call-In Notice that my
 product is  similar enough to another product to  qualify for this option.  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 also submitting a
 completed  " Certification of offer to Cost Share in the Development Data" form.
 I am including a copy of my offer and proof of the other registrant's receipt of that
 offer.  I am identifying the parry which is committing to submit or provide the
 require 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 (Section m-C.l.) apply as'well.

 4.    By the specified due date, I will submit an existing study that has not been
 submitted previously to  the Agency by anyone (submitting an Existing Study).  I
 certify that this study will meet all the requirements for submittal of existing data
 outlined in  option 4 in the Data Call-in Notice (Section III-C.l.) and will meet the
 attached acceptance criteria (for acute  toxicity and product chemistry data). I will
 attach the needed supporting information along with this response. I also certify that
 I have determined that this study will fill the data requirement for which I have
 indicated this choice.

 5.    By the specified  due date,  I will submit or cite data to upgrade  a study
 classified by the Agency as partially acceptable and upgrade (upgrading a study).
 I will submit evidence of the Agency's review indicating that the study  may be
 upgraded and what information is required to do so.  I will  provide the MRID or
 Accession number of the study at the due date.  I understand that the conditions for
 this Option  outlined Option 5  in the Data Call-In Notice (Section III-C.l.) apply.

 6.     By the specified due date, I will cite an existing study that the Agency has
 classified as acceptable or an existing study that has been submitted but not reviewed
 by the Agency (Citing an Existing Study). If 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  EPA 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)
 number (s)  for the cited data on a "Product Specific Data Report" form  or in a
 similar format.   If I cite another registratrant's  data, I will submit a completed
 "Certification With Respect To Data Compensation Requirements" form.

7.     I request a waiver for this study because it is inappropriate for my product
 (Waiver Request). 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

                              258
-------
           £3^M£^^^^^^^«-*"»-
Items 10-13. Self-explanatory.

letter that accompanies this form. ^^^^^^^^^S^^t^ this
are correct.
                                       259
-------
260
-------
Attachment 4. EPA Batching of End-Use Products for
   Meeting Data Requirements for Reregistration
                       261
-------
262
-------
 EPA'S BATCHING OF MINERAL ACID PRODUCTS FOR MEETING ACUTE TOXICITY
 DATA REQUIREMENTS FOR REREGISTRATION

        In an effort  to reduce the time, resources and number of animals needed to fulfill the
 acute toxicity data requirements  for reregistration of products  containing  mineral acids
 (phosphoric acid, hydrogen chloride, sodium bisulfate and sulfuric acid) as the active ingredient,
 the Agency has batched products which can be considered similar for purposes of acute toxicity.
 Factors considered  in the sorting process include each product's active and inert  ingredients
 (identity, .percent composition and  biological activity), type of formulation (e.g., emulsifiable
 concentrate, aerosol, wettable powder, granular, etc.),  and labeling (e.g.,  signal word,  use
 classification, precautionary labeling,  etc.).  Note that the Agency is not describing batched
 products as "substantially similar"  since some products within a batch may not be considered
 chemically similar or have identical use patterns.

        Using available information, batching has been accomplished by the process described
 in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right
 to require, at any time, acute toxicity data for an individual product should the need arise.

       Registrants of products within a batch may choose to cooperatively generate, submit or
 cite a single battery of six acute toxicological studies to represent all the products within that
 batch. It is  the registrants' option to participate in the process with all other registrants, only
 some of the other registrants, or only their own products within a batch, or to generate  all the
 required acute toxicological studies for each of their own products.  If a registrant chooses to
 generate the data for a batch, he/she must use one of the products within the batch as the test
 material. If a registrant chooses to rely upon previously submitted acute toxicity data,  he/she
 may do so provided that the data base is complete and valid by today's standards (see acceptance
 criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
 and the formulation has  not been significantly altered since submission and acceptance  of the
 acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
 registrants must clearly identify the test material by EPA Registration Number. If more than one
 confidential statement of formula (CSF)  exists for a product, the registrant must indicate  the
 formulation actually tested by identifying the corresponding CSF.

       In deciding how to meet the product specific data requirements, registrants must follow
 the directions given  in .the Data  Call-In Notice and its attachments appended to the RED. The
 DCI Notice contains  two response.forms.which.are.to be completed and submitted to the Agency
 within 90 days of receipt. The first form,  "Data Call-in Response,"  asks whether the registrant
 will meet the data requirements for each product. The second form,  "Requirements  Status and
 Registrant's Response," lists the product specific data required for each product, including the
 standard six acute toxicity tests.  A  registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else  to do so.   If a registrant
 supplies the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or  Citing an Existing Study (Option 6),. If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study  (Option 6). If a registrant does not want to participate in a batch, the

          ,                                263
-------
choices are Options 1,  4, 5 or 6.  However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants hi the batch from citing his/her studies
and offering to cost share (Option 3) those studies.

       Two hundred and seven products were found which contain mineral acids as the active
ingredient. The products have been placed into twenty-two batches and a "no batch" category
in accordance with the active and inert ingredients, type Of formulation and current labeling.
Tables 1-4 identify the products hi each batch. Table 5 lists the products which have been placed
in the ,"np batch" category.

  Table 1
Batch
1
2
3




EPA Reg. No.
1124-69
4170-40
4170-53
5741-3
7378-12
8155-7
10292-18
1072-10
3640-66
4524-27
11715-35
1072-18
1839-153
3862-18
4524-41
4875-10
'% Active Ingredient
Phosphoric acid 20.5
Ammonium chloride 0.25
Phosphoric acid 20.0
Ammonium chloride 0.05
Phosphoric acid 20.0
Ammonium chloride 0.05
Phosphoric acid 25.0
Ammonium chloride 0.05 ,
Phosphoric acid 16.0
Ammonium chloride 0.21
Phosphoric acid 20.0
Ammonium chloride 0.1
Phosphoric acid 20.0
Ammonium chloride 0.1
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 6.8
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Phosphoric acid 5.9
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Phosphoric acid 9.0
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Phosphoric acid 8.0
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Phosphoric- acid "6.5
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.6
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq.
Li<1
Liq
                                          264
-------
Batch
• *
EPA Reg. No.
7546-13
8616-7
8781-4
9152-20
% Active Ingredient
Phosphoric acid 7.0
Butoxypolypropoxypolyethoxy-
ethanol- iodine complex 16.0
Phosphoric acid 6.0
Nonylphenoxypolyethoxy-ethanol
iodine complex 9.2
Phosphoric acid 6.5
Nony I phenoxypo lyethoxy- ethano I
iodine complex 18.6
Phosphoric acid 6.0
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Formulation Type
Liq
Liq
Liq
Liq
265
-------
Batch
4
, J
5
6

7



EPA Reg. No.
527-121
875-112
1677-138
3276-18
4462-9
4524-30
6931-2
10634-15
25293-1
50600-3
1622-33
1769-244
875-136
875-137
833-58
875-85
5870-34
34859-6
% Active Ingredient
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 18.0
Phosphoric acid 12.0
Nonylphenoxypolyethoxyethanol-
iodine complex 8.75
Phosphoric acid 15.0.
Nonylphenoxypolyethoxyethanol -
iodine complex 1.75
Phosphoric acid 13.5
Alkyl-omega-hydroxypoly(oxy-
ethylene)- iodine complex 15.7
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 6.4
Octylphenoxypolyethoxyethanol-
iodine complex 12.6
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Phosphoric acid 15.0
Nonylphenoxypolyethoxyethanol-
iodine complex 20.0
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 18.0
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol -
iodine complex 18.0
Phosphoric acid 2.5
Nonylphenoxypolyethoxyethanol-
iodine complex 1.4
Phosphoric acid 3.4
Nonylphenoxypolyethoxyethanol-
iodine complex 9.0
Phosphoric acid 56.2
Dodecy I benzene sulfonic acid 3.4
Phosphoric acid 54.6
Dodecy I benzene sulfonic acid 4.5
Isopropanol 10.0
Phosphoric acid 30.0
Dodecylbenzene sulfonic acid 5.0
Phosphoric acid 30.0
Dodecylbenzene sulfonic acid 5.0
Phosphoric acid 30.0
Dodecylbenzene sulfonic acid 5.2
Phosphoric 'acid 30.0
Dodecylbenzene sulfonic acid 5.0
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
266
-------
Batch
8
9
. i>
10
11


EPA Reg. No.
1677-22
1677-58
1677-150
19713-299
1020-13
1677-56
2686-15
5174-11
6931-4
7546-4
9152-18
1769-228
4959-29
45447-10
% Active Ingredient
• Phosphoric acid 6.5
But oxypo lypropoxypo I yet h oxy-
ethanol-iodine complex 1.75
Phosphoric acid 6.5
But oxypo 1 ypropoxypo I yethoxy-
ethanol- iodine complex 1.75
Phosphoric acid 48.7
Dodecy I benzene sulfonic acid 17.4
Phosphoric acid 48.7
Dodecylbenzene sulfonic acid 17.4
Phosphoric acid 21.0
Dodecylbenzene sulfonic acid 2.75
Phosphoric acid 22.0
Dodecylbenzene sulfonic acid 2.75
Phosphoric acid 20.0
Dodecylbenzene sulfonic acid 5.0
Isopropanol 1.0
Phosphoric acid 23.4
Dodecylbenzene sulfonic acid 3.17
Phosphoric acid 21.0
Phosphoric acid 20.0
Dodecylbenzene sulfonic acid 5.0
Phosphoric acid 22.5
Dodecylbenzene sulfonic acid 5.0
Phosphoric acid 56.9
Dodecylbenzene sulfonic acid 10.7
Isopropanol 10.0
Phosphoric acid 50.0
Dodecylbenzene sulfonic acid 15.0
Phosphoric acid 57.0
Dodecylbenzene sulfonic acid 15.5
Isopropanol 8.5
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Table 2
Batch
^•i^M^B
12




EPA Reg. No.
^Mf^MH^^^M^MH
99-83
421-349
421-350
675-1
675-8
	 % Active Ingredient 	
Hydrogen chloride 23.0
Ammonium chloride 0.05
Hydrogen chloride 27.64
Ammonium chloride 0.2
o-faenzyl p-chlorophenol 0.15
Hydrogen chloride 25.82
Ammonium chloride 0.2
o-benzyl p-chlorophenol 1.0
Hydrogen chloride 23.0
Ammonium chloride 0.05
o-benzyl p-chlorophenol 0.01
Hydrogen chioride 19.0
Ammonium chloride 0.05
Formulation Type
Liq
Liq
Liq
Liq
Liq
                                          267
-------
Bitch
, ,)
EPA Reg. No.
1459-24
1622-35
1839-105
1839-148
3862-89
4170-52
5741-11
6836-84
7378-10
8155-3
8370-2
9367-5
10693-2
39272-2
48211-31
% Active Ingredient
Hydrogen chloride 25.0
Ammonium chloride 0.22
Hydrogen chloride 23.0
Ammonium chloride 0.5
Hydrogen chloride 20.0
Ammonium chloride 1.5
Hydrogen chloride 23.0
Ammonium chloride 0.25
Hydrogen chloride 23.0
Ammonium chloride 0.75
Hydrogen chloride 23.0
Ammonium chloride 0.05
Hydrogen chloride 23.0
Ammonium chloride 0.05
Hydrogen chloride 20.3
Ammonium chloride 0.7
Hydrogen chloride 24.0
Ammonium chloride 0.21
Hydrogen chloride 23.0
Ammonium chloride 0.05
Hydrogen chloride 24.0
Ammonium chloride 0.25
Hydrogen chloride 24.7
Ammonium chloride 0.3
Hydrogen chloride 23.0
Ammonium chloride 0.2
Hydrogen chloride 27.64
Ammonium chloride 0.22
Hydrogen chloride 20.32
Ammonium chloride 0.75
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Batch
                  EPA Reg.  No.
% Active Ingredient
Formulation Type
   13
                    334-361
                    421-339
                     675-34
                     777-29
                    1839-104
                    2230-56
                    4170-39
                                               Hydrogen chloride 9.0
                                              Ammonium chloride 0.36
                                              Hydrogen chloride 9.49
                                               Ammonium chloride 0.2
                                               Hydrogen chloride 8.0
                                               Ammonium chloride 1.0
                                               Hydrogen chloride 9.5
                                              Ammonium chloride 0.75
                                               Hydrogen chloride 8.0
                                               Ammonium chloride 1.0
                                               Hydrogen chloride 9.5
                                              Ammonium chloride 0.06
                                               Hydrogen chloride 9.0
                                              Ammonium chloride 0.05
                                         Liq
                                         Liq
                                         Liq
                                         Liq
                                         Liq
                                         Liq
                                         Liq
                                                268
-------
Batch
' *
EPA Reg. No.
4170-54
4822-410
5664-18
6836-85
7378-3
8155-4
8325-27
8370-1
9367-36
11694-27
39272-3 .
48211-26
% Active Ingredient
: Hydrogen chl'oride 9.0
Ammonium chloride 0.05
Hydrogen chloride 9.25
Ammonium chloride 0.6
Hydrogen chloride 9.6
Ammonium chloride 1.5
Hydrogen chloride 9.6
Ammonium chloride 0.75
I Hydrogen chloride 7.5
Ammonium chloride 0.6
Hydrogen chloride 9.0
Ammonium chloride 0.05
Hydrogen chloride 8.0
Ammonium chloride 1.0
Hydrogen chloride 8.0
Ammonium chloride 0.25
Hydrogen chloride 9.6
Ammonium chloride 0.75
Hydrogen chloride 9.0
Ammonium chloride 0.2
Hydrogen chloride 9.49
Ammonium chloride 0.22
Hydrogen chloride 9.6
Ammonium chloride 0.75
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
269
-------
Batch
14
15
, £
16
17
18

EPA Reg. No.
47371-87
47371-172
334-281
4000-70
4000-71
8503-10
257-131
303-61
334-285
491-103
1203-25
1270-29
2155-30
4000-69
15567-1
2528-36
5741-17
257-332
8155-6
X Active Ingredient
Hydrogen chloride 17.75
Ammonium chloride 1.44
Hydrogen chloride 16.5
Ammonium chloride 1.44
Hydrogen chloride 9.45
Hydrogen chloride 9.5
Hydrogen chloride 9.4
Hydrogen chloride 9.8
Hydrogen chloride 23.0
Hydrogen chloride 23.0
Hydrogen chloride 23.7
Hydrogen chloride 24.0
Hydrogen chloride 23.0
Hydrogen chloride 23.0
Hydrogen chloride 24.0
Hydrogen chloride 23.0
Hydrogen chloride 23.0
Hydrogen chloride 9.55
Ammonium chloride 0.2
Hydrogen chloride 9.5
Ammonium chloride 0.5
Hydrogen chloride 9.0
Ammonium chloride 1.2
Hydrogen chloride 9.5
Ammonium chloride 0.1
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Lid
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Table 3
Batch
19
20
21
EPA Reg. Mo.
777-50
4822-407
475-191
475-198
475-142
475-177
475-225
% Active Ingredient
Sodium bisulfate 62.0
Sodium bisulfate 62.0
Sodium bisulfate 62.0
Sodium bisulfate 62.0
Sodium bisulfate 81.0
Sodium bisulfate 75.0
Sodium bisulfate 81.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
                                          270
-------
  Table 4
Batch
22
' D*
EPA Reg. No.
567-8
57559-1
62589-1
65878-1
66602-1
67217-1
X Active Ingredient
Sulfuric acid 93.0
Sulfuric acid 93.0
Sulfuric acid 93.0
Sulfuric acid 93.0
Sulfuric acid 93.0
Sulfuric acid 93.0
Formulation Tvoe
Solid
Solid
Solid
Solid
Solid

        The  following, table  lists  products that were  either, considered not  to be  similar  or the  Agency
lacked sufficient  information .for decision making and  were not placed  in  any batch. Registrants of  these
products are responsible for meeting the acute toxicity  data requirements separately for each product.

  Table 5  (No Batch)
EPA Reg. No.
52-111
150-61
334-303
402-92
421-237
421-391
475-69
475-195
475-196
475-199
475-350
550-152
602-294
675-39
% Active Ingredient
Hydrogen chloride 0.11
Nonylphenoxypolyethoxyethano 1 -
iodine complex 8.74
Polyethoxypolypropoxyethanol-
iodine complex 9.1
Phosphoric acid 45.0
Dodecylbenzene sulfonic acid 10.6
Hydrogen chloride 9.5
Nonylphenoxypolyethoxyethanol-
iodine complex 3.0
Hydrogen chloride 7.23
Phosphoric acid 24.75
Sulfamic acid 0.5
Ammonium chloride 1.5
Phosphoric acid
Nonylphenoxypolyethoxyethanol-
iodine complex 0.875
Phosphoric acid 25.0
Hydrogen chloride 7.0
Oxalic acid 2.0
Sodium bisulfate 68.0
Sodium bisulfate 50.0
Hydrogen chloride 7.0
Ammonium chloride 0.2
Hydrogen chloride 8.35
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 9.0
Nonylphenoxypolyethoxyethanol-
iodine complex 27.6
Phosphoric acid 0.85 . '". "
Hydrogen peroxide 6.0
Formulation Type
Liq
Liq
Liq
Liq
Liq
	 Liq 	
Liq
Solid
Solid
Liq
Liq
Liq
Liq
Liq
                                                   271
-------
EPA Reg. No.
833-65
833-66
875-88
875*-90
875-96
875-97
875-100
875-115
875-153
875-156
875-157
875-168
1370-204
1317-68
1677-89
1677-90
1677-95
1677-100
1677-132
1677-152
1769-161
1839-60
1913-12
% Active Ingredient
Phosphoric acid 15.0
Sulfonated oleic acid 5.0
Phosphoric acid 6.5
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Hydrogen chloride 5.48
Phosphoric acid 5.2 Iodine 1.75
Phosphoric acid 15.0
Phosphoric acid 15.75
Iodine 1.75
Phosphoric acid 18.75
Iodine 1.75
Phosphoric acid 59.8
Phosphoric acid 0.632
Nonylphenoxypolyethoxyethanol -
iodine complex 17.6
Hydrogen chloride 4.71
Phosphoric acid 22.5
Phosphoric acid 6.0
Nonylphenoxypolyethoxyethanol-
iodine complex 16.7
Potassium iodide 2.0
Hydrogen chloride 12.58
Phosphoric acid 4.49
Phosphoric acid 6.75
Iodine 1.76
Hydrogen chloride 5.5
Phosphoric acid 22.5
Phosphoric acid 22.0
Nonylphenoxypolyethoxyethanol-
iodine complex 18.0
Phosphoric acid 25.0
Polyethoxypolypropoxyethanol-
iodine complex 3.5
Phosphoric acid 23.8
Citric acid 20.0
Phosphoric acid 25.5 ,
Phosphoric acid 17.4
Phosphoric acid 29.3
Polyethoxypolypropoxyethanol -
iodine complex 4.3
Phosphoric acid 37.5
Hydrogen chloride 18.5
Ammonium chloride 1.5
Phosphoric acid 8.5
Ammonium chloride 1.0 '•
Hydrogen chloride 9.25
Ammonium chloride 0.6
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
„., _ Lic!'
Liq
272
-------
EPA Reg. No.
2230-43
2230-55
2230-58
2344-4
3573-26
3862-119
% Active Ingredient
Hydrogen chloride 10.4
Ammonium chloride 0.42
Phosphoric acid 14.62
Ammonium chloride 0.2
Hydrogen chloride 23.9
Ammonium chloride 0.45
Phosphoric acid 25.73
Dodecylbenzene sulfonic acid 3.36
Hydrogen chloride 15.0
Phosphoric acid 6.0
Ammonium chloride 1.0
/
'Phosphoric acid 20.0
Ammonium chloride 0.05
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
EPA Reg. No.
4000-91
4524-22
4822-54
4822-408
4822-409
4959-9
4959-21
4959-23
4959-36
4959-41
4959-42
5197-34
5389-12
5741-23
5813-13
% Active Ingredient
Hydrogen chloride 8.0
Ammonium chloride 2.5
Phosphoric acid 45.0
Hydrogen chloride 14.4
. Sodium bisulfate 75.0
Sodium bisulfate 81.0
Phosphoric acid 40.0
Iodine. 1.6
Phosphoric acid 11.5
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Phosphoric acid 15.95
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Phosphoric acid 24.7
Polyethoxypolypropoxyethanol-
iodine complex 3.5
Phosphoric acid 8.5
Sulfuric acid 9.5
Propionic acid 10.0
Nonanoic acid 3.0
Phosphoric acid 28.5
. Nonanoic acid 3.0
Propionic acid 10.0
Hydrogen chloride 23.83
Ammonium chloride 0.08
Phosphoric acid 11.25
Dodecylbenzene sulfonic acid 1.0
Phosphoric acid 12.0
Ammonium chloride 0.5
Hydrogen chloride 8.0
Ammonium chloride 0.5
Formulation Type
Liq
Liq
Liq
Solid
Solid
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
273
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EPA Reg. No.
••••••••MiiMHB
5991-31
6718-21
6836-39
6836-42
7546-5
8155-19
8370-4
8503-6
10292-10
10292-20
10693-9
10807-105
10807-139
11292-3 .
13215-1
13215-3
15567-4
15567-5
15567-8
35495-14
35900-10
35900-11
47371-86
47371-150
57125-5
	 X Active Ingredient 	
•^^^•••••^•ii^^^^^^^^^^^^^^^^^^^^^^^^^
Phosphoric acid 45.0
Dodecylbenzene sulfonic acid 13.73
Sodium bisulfate 74.4
Hydrogen chloride 8.0
Ammonium chloride 2.5
Hydrogen chloride 17.5
Ammonium chloride 2.5
Phosphoric acid 15.0
Ammonium chloride 5.0
Hydrogen chloride 14.5
Phosphoric acid 18.75
Ammonium chloride 0.25
Hydrogen chloride 23.0
Ammonium chloride 0.06
Hydrogen chloride 9.5
Ammonium chloride 0.6
Phosphoric acid 2.0
Hydrogen chloride 6.0
Phosphoric acid 10.0
Nonylphenoxypolyethoxyethanol-
iodine complex 6.4
Hydrogen chloride 9.5
Octylphenoxypolyethoxyethanol-
Hydrogen chloride 9.6
Ammonium chloride 0.75
Hydrogen chloride 21.8
Phosphoric acid 45.0
Hydrogen chloride 18.0
Hydrogen chloride 8.5
Hydrogen chloride 8.5
Hydrogen chloride 14.5
Phosphoric acid 30.0
Dodecylbenzene sulfonic acid 25.6
Phosphoric acid 75.5
Phosphoric acid 0.13
Hydrogen chloride 8.16
Ammonium chloride 1.44
Hydrogen chloride 9.45
Ammonium chloride- 1.44 ••-••-. •-•-""
Hydrogen chloride 14.5
Ammonium chloride 0.1
Formulation Type
•••••••^B
Liq
Solid
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Solid
Liq
Liq
Liq
Liq
liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
274
-------
EPA Reg. No.
61181-1
% Active Ingredient
Phosphoric acid 6.8 '-'
Iodine 1.75
Formulation Type
.Liq
275
-------
276
-------
Attachment 5. EPA Acceptance Criteria
                 277
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278
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                                  SUBDIVISION D
Guideline           Study Title

Series 61            Product Identity and Composition
Series 62            Analysis and Certification of Product Ingredients
Series 63 ,\           Physical and Chemical Characteristics
                                        279
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                                 61 Product Identity and Composition


ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

1.	    Name of technical material tested (include product name and trade name, if appropriate).
        ,  ,t
2.	    Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
          intentionally-added inert ingredient.

3.	    Name and upper certified limit for each impurity or each group of impurities present at .>. 0.1% by
          weight and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines)  present at
          <0.1%.

4.	    Purpose of each active ingredient and each intentionally-added inert.

5.        Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
          Registry Number for each active ingredient and, if available, for each intentionally-added inert.

6.	    Molecular, structural,  and empirical formulas, molecular weight or weight range, and any company
          assigned experimental or internal code numbers for each active ingredient.

7.	    Description of each beginning material in the manufacturing process.
          	 EPA Registration Number if registered; for other beginning materials,      the     following:

          	 Name and address of manufacturer or supplier.
          	 Brand name, trade name or commercial designation.
          	 Technical specifications or data sheets by which manufacturer or supplier describes composition,
                properties or toxicity.

8.	Description of manufacturing process.
          	 Statement of whether batch or continuous process.
          	 Relative amounts of beginning materials and order in which they are added.
          	 Description of equipment.
          	 Description of physical conditions (temperature, pressure, humidity) controlled in each step and
                the parameters that are maintained.
          	 Statement of whether process involves intended chemical reactions.
          	 Flow chart with chemical equations for each intended chemical reaction.
          	 Duration of each step of process.
          	 Description of purification procedures.
          	 Description of measures taken to assure quality of final product.

9.	    Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
          which may be present at  >, 0.1% or was found at >_ 0.1% by product analyses  and (2) certain
          lexicologically significant impurities (see #3).
                                                 280
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                           62 Analysis and Certification of Product Ingredients


                                       ACCEPTANCE CRITERIA

The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8.

Does your study meet the following acceptance criteria?

 1 •	' Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
         and,all impurities present at > 0.1%.
 2.	  Degree of accountability or closure >_ ca 98 %.
 3.	.  Analyses conducted for certain trace toxic impurities at lower than 0.1 % (examples, nitrosamines in the
         case of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus
         nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both
         fresh and stored samples must be analyzed.].
 4.	  Complete and detailed description of each step in analytical method used to analyze above samples.
 5.	  Statement of precision and accuracy of analytical method used to analyze above samples.
 6.	  Identities and quantities (including  mean and standard deviation) provided for each analyzed ingredient.
 7.	  Upper and lower .certified limits proposed for each active ingredient and intentionally added inert along
         with explanation of how the limits  were determined.
 8.	  Upper certified  limit  proposed for each impurity  present at  >_ 0.1%  and for  certain  lexicologically
         significant impurities at <0.1% along with explanation of how limit determined.
 9.	  Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
         if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10.	  Analytical methods (as discussed in #9)  to verify certified limits validated as  to their precision and
         accuracy.
                                                 281
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                                63 Physical and Chemical Characteristics

                                        ACCEPTANCE CRITERIA


 The following criteria apply to the technical grade of the active ingredient being reregistered.

 Docs your study meet the following acceptance criteria?

 63-2 Color %
    	'  Verbal description of coloration (or lack of it)
    	  Any intentional coloration also reported in terms of Munsell color system

 63-3 Physical State
    	  Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
    	  Based on visual inspection at about 20-25° C

 63-4 Odor
    	  Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
           compounds"
    	  Observed at room temperature

 63-5 Melting Point
    	  Reported in °C
    	  Any observed decomposition reported

 63-6 Boiling Point
    	  Reported in °C
    	  Pressure under which B.P. measured reported
    	  Any observed decomposition reported

 63-7 Density,  Bulk Density, Specific Gravity
    	  Measured at about 20-25° C
    	  Density of technical  grade active ingredient reported in g/ml or the specific gravity of liquids reported
           With reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3
           or Ibs/gallon.]

 63-8 Solubility
    	   Determined in distilled water and representative polar and non-polar solvents, including those used hi
           formulations and analytical methods for the pesticide
    	   Measured at about 20-25° C
    	   Reported in g/100 ml (other units like ppm acceptable if-sparingly soluble)

63-9 Vapor Pressure
    	   Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
           pressure too low to measure at 25° C)
    	   Experimental procedure described
    	   Reported in mm Hg  (ton) or other conventional units

63-10 Dissociation Constant
    	   Experimental method described
                                                  282
-------
   	  Temperature of measurement specified (preferably about
          20-25 °C)

63-11 Octanol/water Partition Coefficient
   	  Measured at about 20-25° C
   	  Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
          77350)
   	  Data supporting reported value provided

63-12 pH  j
   	' Measured at about 20-25° C
   	  Measured .following dilution or dispersion in distilled water

63-13 Stability
   	  Sensitivity to metal ions and metal determined
   	  Stability at normal and elevated temperatures
   	  Sensitivity to sunlight determined
                                                  283
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                                          SUBDIVISION F
Guideline          Study Title

 81-1          Acute Oral Toxicity in the Rat
 81-2          Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
 81-3          Acute Inhalation Toxicity in the Rat
 81-4          Primary Eye Irritation hi the Rabbit
 81-5      ,    Primary Dermal Irritation Study
 81-6          Dermal Sensitization in the Guinea Pig
                                                284
-------
                                   81-1 Acute Oral Toxicity in the Rat


                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	At feast 5 young adult rats/sex/group.
 3.	bo'sing, single oral may be administered over 24 hrs.
 4."	Vehicle control if other than water.
 5.	Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
 6.	Individual observations at least once a day.
 7.	Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
 8.	Individual daily observations.
 9.	Individual body weights.
10.	Gross necropsy on all animals.
                     Criteria marked with an * are supplemental and may not be required for every study.
                                                  285
-------
                      81-2  Acute Dermal toxicity in the Rat, Rabbit or Guinea Fig


                                       ACCEPTANCE CRITERIA


Docs your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	A^ least 5 animals/sex/group.
 3.*     Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
 4.	Dosing, single dermal.
 5.	Dosing duration at least 24 hours.
 6.*	Vehicle control, only if toxicity of vehicle is unknown.
 7.	Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
 8.	Application site clipped or shaved at least 24 hours before dosing.
 9.	Application site at least 10% of body surface area.
10.	Application site covered with a porous nonirritating cover to retain test material and to prevent
        ingestion.
11.	Individual observations at least once a day.
12.	Observation period to last at least 14 days.
13.	Individual body weights.
14.	Gross necropsy on all animals.
                    Criteria marked with an * are supplemental and may not be required for every study. '
                                                  286
-------
                               81-3 Acute Inhalation Toxicity in the Rat


                                       ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
 1.	Identify material tested (technical, end-use product, etc).
 2.	Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
        'orcontains particles of inhalable size for man (aerodynamic diameter 15 urn or less).
 3.	At least 5 young adult rats/sex/group.
 4.	Dosing, at least 4 hours by inhalation.
 5.	Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
 6.	Chamber temperature, 22° C  (±2°), relative humidity 40-60%.
 7.	Monitor rate of air flow.
 8.	Monitor actual concentrations of test material in breathing zone.
 9.	Monitor aerodynamic particle size for aerosols.
 10.     Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
        respirable substance).
 11.	 Individual observations at least once a day.
 12.	 Observation period to last at least 14 days.
 13.	 Individual body weights.
 14.	 Gross necropsy on all animals.
                                                   287
-------
                               81-4  Primary Eye Irritation in the Rabbit


                                       ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive, causes severe
        dermal irritation or has a pH of <2 or >11.5.
 3.	6 adult rabbits.
 4.	Dosing, instillation into the conjunctiva! sac of one eye
        per animal.
 5.	Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
 6.	Solid or granular test material ground to a fine dust.
 7.	Eyes not washed for at least 24 hours.
 8.	Eyes examined and graded for irritation before dosing and
        at 1, 24, 48 and 72 hr, then daily until eyes are normal
        or 21  days (whichever is shorter).
 9.*	Individual daily observations.
                    Criteria marked with an * are supplemental and may not be required for every study.
                                                 288
-------
                                  81-5 Primary Dermal Irritation Study

                                       ACCEPTANCE CRITERIA


Does your study meet the following acceptance criteria?

 1.	Identify material tested (technical, end-use product, etc).
 2.	Study not required if material is corrosive or has a pH of <2 or J>_11.5.
 3.	6 adult animals.
 4.	Dosing, single dermal.
 5.	Dosing duration 4-hours.
 6.	Application site shaved or clipped at least 24 hours prior to dosing.
 7.	Application site approximately 6 cm2.
 8-	Application site covered with a gauze patch held hi place with nonirritating tape.
 9.	Material removed, washed with water, without trauma to application site.
10-	  Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
        days (whichever is shorter).
11.*	  Individual daily observations.
                   Criteria marked with an * are supplemental and may not be required for every study.
-------
                              81-6 Dermal Sensitization in the Guinea Fig

                                       ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?

1.	Identify material tested (technical, end-use product, etc).
2.	Study not required if material is corrosive or has a
      pH o(.<2 or >11.5.
3.	One of the following methods is utilized:
      	Freund's complete adjuvant test
      	Guinea pig maximization test
      	Split adjuvant technique
      	Buehler test
      	Open epicutaneous test
      	Mauer optimization test
      	Footpad technique in guinea pig.
4.	Complete description of test.
5.J	Reference for test.
6.	Test followed essentially as described in reference document.
7.	Positive control included (may provide historical data conducted within the last 6 months).
                    Criteria marked with an * are supplemental and may not be required for every study.
                                                 290
-------
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
                              Notice
                               291
-------
292
-------
Attachment 7. Cost Share Data Compensation Form, and Confidential
                  Statement of Formula Form
                             293
-------
294
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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 hi and answered completely.
.*
               b^  ,11    If any block is not applicable, mark it N/A.

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

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

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

               f.       Flashpoint must be in degrees Fahrenheit and flame extension in niches.

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

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

               i.       For the  active ingredients, the percent  purity of the source products must be
                       reported under column 10  and must be exactly  the same as on  the source
                       product's label.
              j.       All  the weights in columns  13.a. and 13.b. must be in pounds,  kilograms, or
                       grams. In no case  will volumes be accepted.  Do  not mix English  and metric
                       system units  (i.e., pounds and kilograms).

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

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

              m.      The upper and lower certified  limits for ail active and inert ingredients must
                      follow the 40 CFR 158.175 instructions.  An explanation must be provided if the
                      proposed limits are  different than standard certified limits.

              n.      When new CSFs are submitted and approved, all previously'submitted CSFs
                      become obsolete for that specific formulation.


                                                  297
-------
298
-------
unmo stat., Enviroomtntal Prottctlon Agtnly
           EPA
         Washington. DC 2046O
                WITH RESPECT TO
                               *
OHI H*. 2870-0101

      2070-8017
                      REQUIEMENTS
                                                 IEMENTS *„«» &^»,,

                                                           n tstlmate or "V oth«r
                                                       '     '           y

   Pfeas* OH in blanks b«iow.


         Nam«,
                               s.

EPA Form M70-J1 (4.10)
                                   299
-------
300
-------
 APPENDIX A. MEMORANDUM OF UNDERSTANDING
 BETWEEN THE FOOD AND DRUG ADMINISTRATION,
PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH
 AND HUMAN SERVICES AND THE ENVIRONMENTAL
             PROTECTION AGENCY
                    301
-------
302
-------
                                  Memorandum of Understanding
                                            Between
                     The Food and Drug Administration, Public Health Service,
                             Department of Health and Human Services
                                              and
                               The Environmental Protection Agency


 Notice Regarding Matters of Mutual Responsibility - Regulation of Liquid Chemical Germicides Intended
 for Use on Medical Devices

 I.  PURPOSE

 This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA) and the
 Environmental Protection Agency (EPA) clarifies jurisdiction between the two agencies in the regulation
 of certain liquid chemical germicides. These liquid chemical germicides are devices under the Federal
 Food, Drug, and Cosmetic Act (FD&C Act) and pesticides under the Federal Insecticide, Fungicide and
 Rodenticide Act (FIFRA). This MOU also embodies the agreement of the two agencies to undertake certain
 rulemakings hi order to eliminate duplicative regulation of certain types of liquid chemical germicides. This
 MOU includes the agencies' interim agreement to simplify and coordinate their regulatory and enforcement
 activities hi shared areas  of jurisdiction affecting these types of products pending the conclusion of these
 rulemakings.

 H.  STATUTORY AUTHORITIES

 A.  FDA Authorities

 The FD&C Act grants FDA authority to regulate devices as defined in 21 U.S.C. §321(h). Under section
 321(h),  the term "device" includes an instrument, apparatus, implement, machine, contrivance,  implant,
 in vitro reagent, or other similar or related article, including any component, part, or accessory that is
 intended to cure, mitigate, treat, or prevent disease in man, or is intended to affect the structure or any
 function of the body of man. Liquid chemical germicides intended for use in conjunction with a variety of
 articles that fit within the statutory definition of "device," such as operating instruments, medical examining
 tables, hospital scales, and other hospital equipment, also fall within the definition of "device", because
 they are considered accessories to these devices.

 Unless liquid chemical germicides used hi conjunction with devices were  commercially distributed prior
 to May  28,  1976,1  manufacturers of these products, under 21 U.S.C. §360(k) [section 510(k) of the
 FD&C Act] are required  to submit a premarket notification to FDA before they market their products.
 Before these products can be legally marketed, FDA must grant marketing  clearance by (1) issuance of an
 order in response to a section 510(k) submission which exempts the device from the FD&C Act's premarket
 approval requirements, or (2) approval of a premarket approval application. In granting marketing clearance
 by issuance  of a section 510(k) order exempting a liquid chemical germicide from premarket approval,
 FDA  must find that the device is  "substantially equivalent," as the term is defined in 21 U.S.C.
 §360c(i)(l)(A), to a predicate device that does not require premarket approval. Section 513 of the FD&C
Act authorizes FDA to exempt products from premarket notification requirements for which there is a
    1  Devices marketed prior to  May 28, 1976  are grandfathered from the FD&C  Act's
premarket notification  requirements.   Neither FDA nor EPA are aware  of any currently
marketed products that are exempt under this grandfather provision.  Should any exist, they are
not covered by this Memorandum of Understanding.
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  reasonable assurance of safety and effectiveness. At present, no chemical germicides that are used with
  devices have been exempted from premarket notification requirements.

  In regulating liquid chemical germicides used with devices, FDA is exercising its responsibilities under the
  FD&C Act for ensuring that devices are safe and effective for their intended uses. The FD&C Act provides
  enforcement authority to FDA to pursue regulatory actions, including seizure, injunction, prosecution, and
  civil penalties.

  B.  EPA Authorities

  Liquid chemical germicides, including those regulated as devices, are also under the authority of the EPA
 under FEFRA. Before a pesticide product may be lawfully sold or distributed in commerce, the product
 must be registered by EPA pursuant to FIFRA section 3, or otherwise exempted from the requirements of
 FIFRA. A registration is a license allowing a pesticide product to be sold and distributed for specified uses
  in accordance with specified use instructions, precautions, and other terms and conditions. Liquid chemical
 sterilants are included among the various types of antimicrobial products that are currently subject to
 FIFRA.

 A pesticide product may  be registered or remain registered only if it meets the statutory standard for
 registration. Among other things, a pesticide must perform its intended pesticidal function without causing
  "unreasonable adverse effects on the environment" (FIFRA section 3(c)(5)). "Unreasonable adverse effects
 on the environment" is defined as "any unreasonable risk to man or the environment, taking into account
 the economic, social, and environmental costs and benefits of the use of [the] pesticide" (FIFRA section
 2(bb)).

 The burden of demonstrating that a pesticide product satisfies the statutory criteria for registration is at all
 times on the proponents of initial  or continued registration. FIFRA section 6 provides EPA with various
 regulatory tools that the Administrator may use if it appears that the product no longer satisfies the statutory
 criteria for registration. If appropriate, EPA may require modifications to the terms and conditions of
 registration, such as deletion of particular uses or revisions to labeling, as an alternative to  regulatory
 outcomes such as cancellation,  suspension, or emergency suspension. FIFRA also provides enforcement
 authority to EPA to pursue actions, including issuance of stop sale, use, or removal orders when there is
 reason  to believe a pesticide is in violation of FIFRA. Additionally, EPA has authority to seek the
 assessment of civil administrative penalties as well as institute seizure and criminal actions for violations
 of FIFRA.

 FIFRA section 25(b) authorizes the Administrator to exempt pesticides from FIFRA through regulation if
 the Administrator determines that the pesticide is "adequately regulated by another Federal agency" or is
 "of a character which it is  unnecessary to be subject to this Act hi order to carry out the purposes of this
 Act."                                   '

 m. REGULATORY RESPONSIBILITIES AND DEFINITIONS

 For the purposes  of this agreement, liquid chemical germicides that are used in conjunction with medical
 devices are divided into two product categories: (1) sterilants and (2) general purpose disinfectants.
 Sterilants, for purposes of this agreement, means those chemical germicides used to reprocess reusable
 critical and semicritical devices2. Critical devices are devices that are introduced directly into the human
    2
      This definition is consistent with the definition of these terms used by the Centers for
Disease Control and Prevention  (CDC).  Block, S.S.  1991. Disinfection, Sterilization  and-
Preservation. 4th Edition. Philadelphia, Lea & Febiger.
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 body, either into or in contact with the bloodstream or normally sterile areas of the body. These critical
 devices must be sterile. Semicritical devices are those which contact intact mucous membranes but which
 do not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. For these
 devices, sterilization is desirable but not mandatory. These devices must be subjected at least to a high level
 disinfection3 process using a sterilant, but for a shorter time than that required for sterilization.

 The second category of liquid  chemical germicides are general purpose disinfectants. General purpose
 disinfectants, for purposes of this agreement, means those chemical germicides used to reprocess noncritical
 devices and medical equipment surfaces4. Noncritical devices and medical equipment surfaces must be
 subjected to intermediate or low level disinfection5.

 FDA's priority is to confirm the efficacy and safety of sterilants used to reprocess critical and semicritical
 devices which  pose the  greatest risk of disease transmission. This includes assuring that they do not
 adversely affect device performance or pose a hazard to the patient/user.  Historically, EPA has assessed
 the effective performance of all chemical germicides and addressed health and safety issues their use.

 The FD&C  Act and FIFRA have overlapping regulatory schemes for liquid chemical germicides used on
 devices. The objective of this MOU is to minimize redundant regulation of these products by FDA and
 EPA while assuring that the safety and  efficacy requirements of both statutes are met. This affects
 three areas: data requirements for obtaining approval, procedures for obtaining approval, and compliance.

 In determining whether the FD&C Act's and FIFRA's statutory and regulatory requirements are met, EPA
 and FDA will  utilize the data requirements and performance standards  referenced hi FDA's current
 Guidance  on the  Content  and  Format  of Premarket Notification  Submission  for  Liquid Chemical
 Germicides, FDA  premarket notification regulations at 21  CFR Part  807,  Subpart  E, EPA  data
 requirements regulations at 40 CFR Part 158, and EPA's Subdivision G, Product Performance Guidelines.

 Since  the  EPA registration requirements for general purpose disinfectants parallel  the requirements
 necessary to receive marketing  clearance for general  purpose disinfectants under section 510(k) of the
 FD&C Act,  fulfillment of EPA's registration requirements fulfills FDA's section 510(k) requirements for
 those products.

 The EPA  efficacy  data  requirements  for liquid  chemical sterilants,  including those with high level
 disinfectant uses, are fulfilled by FDA's section 510(k) requirements or premarket approval requirements
 Therefore, premarket clearance by FDA fulfills certain EPA registration requirements for liquid chemical
 sterilants, insofar as efficacy and product performance  are concerned. FDA premarket clearance does not
 satisfy EPA's chemistry, toxicology^ and ecological effects requirements.

 IV. AGREEMENT
                         •—j                           »- -
    3 "High level disinfectant" and "high level disinfection" are terms of are used by the public
health community.  FDA recognizes "high level disinfectant" as a separate or subcategory of
sterilants. EPA does not register "high level disinfectants" as separate antimicrobial pesticides,
but instead may register uses of germicides that correspond with uses hi FDA's "high level
disinfection" category.

    4 This definition is consistent with the definition of the temi'used by CDC.

    5 "Low  and intermediate level disinfectants"  are terms of art used by the public health
community.   FDA recognizes "low and intermediate level disinfection" as subcategories of
general purpose  disinfectants.   EPA  does  not  register low level and intermediate  level
disinfectants, but  has corresponding germicide classes.

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  iiie Administrator of the Environmental Protection Agency and the Commissioner of the Food and Drug
  Administration agree that until exemptions referred to in Section V occur,  the following division of
  responsibility will govern the activities of the agencies in the regulation of liquid chemical germicides that
  are intended for use on devices:


  A.  Regulatory Responsibilities

  1.      FDA will be primarily responsible for the premarket review of safety and efficacy requirements for
         liquid chemical germicides that are sterilants6 intended for use  on critical or  semicritical devices.
         Examples of critical devices are laparoscopes, surgical instruments, heart-lung  oxygenators, and
         transfer  forceps. Examples of semicritical devices are gastrointestinal  endoscopes,  endotracheal
         tubes, cystoscopes, anesthesia breathing circuits, and vaginal specula. FDA will  also be primarily
         responsible for premarket review of contact lens solutions.


  2.      EPA will be primarily responsible for premarket review of liquid chemical germicides that are
         general purpose disinfectants7 intended for use on devices other than critical or  semicritical devices.
         Examples of noncritical devices are wheel chairs,  medical  beds, stands,  certain operating room
         surfaces, medical lamps, dental units, and stethoscopes.

  3.     FDA marketing clearance through the section 510(k) process or approval through the premarket
        approval process of sterilants will satisfy certain requirements for registration under FIFRA Section
        3. Upon submission to EPA  by the  applicant of an order issued  by FDA  granting marketing
        clearance or approval for a liquid chemical germicide that is a sterilant,  EPA will consider the
        efficacy data requirements for registration to be satisfied, and will promptly determine whether the
        other requirements for registration are satisfied.

 4.      EPA registration of liquid chemical germicides that are used as disinfectants  for devices, except
        sterilants, will satisfy the criteria necessary to .establish substantial  equivalence as defined in 21
        U.S.C.  §360c(i)(l)(A). For  this category of liquid chemical germicides,  submission by  the
        manufacturer to FDA of a copy of the EPA correspondence granting registration will satisfy FDA's
        requirement for a premarket notification under 21 U.S.C. §360(k). Upon receipt of this information
        from the manufacturer of a liquid chemical germicide in this category, FDA  will issue  an order
        finding the product substantially equivalent to a predicate device that does not require premarket
        approval. This  order will allow the device to be legally marketed without  an approved FDA
        premarket approval application.

 5.      As part of the EPA registration process, EPA will require registrants of liquid chemical germicides
        other than  sterilants that have received  FDA premarketing clearance or  approval  to  put the
        following statement on their product labels:
    6 If a liquid chemical sterilant product has subordinate claims such as tuberculocidal or
virucidal, these claims also will be regulated by FDA.

    7 Procedures described in Paragraph 4 only apply to liquid chemical germicide products that
do  not  contain any. sterilant claims.   If a liquid chemical germicide product  contains both
sterilant and general purpose disinfectant  claims, registration will proceed according to the
procedures described in Paragraph 3.  If the registrant of a general purpose disinfectant product
registered by EPA subsequently applies for registration of a sterilant claim, registration of that
product must proceed under procedures  described  in Paragraph 3 and the existing EPA
registration will become void upon FDA's clearance of the product.

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                This product is not to be used on any surface or instrument that (1) is introduced directly
               into the human body, either into or in contact with the bloodstream or normally sterile areas
               of the body,  or (2) contacts intact mucous membranes  but which does  not  ordinarily
               penetrate the blood barrier or otherwise enter normally sterile areas of the body."

  B.     Compliance Responsibilities

  1.      FDA will be  responsible for  all sampling and all efficacy testing of liquid chemical sterilants
         intended for use on critical and semicritical  devices and for instituting appropriate enforcement
         and/or regulatory action against any products that do not comply with the FD&C Act.

         Upon request, EPA will provide FDA with copies of the latest accepted labeling and the name and
         location of the production site  for each product FDA intends to sample.
        n         voi        1 U-S'C- § 331j' 21 U'S-C-  §36°MC>> 42 U.S.C. §263g(d), 42
        U.S.C. 263i(e), and 21 C.F.R. Part 20, FDA will share all safety and efficacy test results  labeling
        changes, and upon EPA request, any other information obtained during FDA enforcement/regulatory
        actions relating to liquid chemical sterilants. EPA may use this information to determine whether
        the registrant has complied with FIFRA. On the basis of this information, EPA may determine that
        further regulatory action under FIFRA, including cancellation of the product's registration is
        warranted.                                                                              '

 2.     EPA will be responsible for the sampling  and efficacy testing of all general  purpose chemical
        germicides that are intended for use on devices  other than critical and semicritical devices  and for
        instituting appropriate enforcement and/or regulatory action against any such chemical germicide
        that does not comply with FIFRA. EPA will refer labels and other evidence concerning inefficacious
        liquid chemical germicides intended for use on medical devices other than critical or semicritical
        to bDA for complementary action under the FD&C Act.

 3 .      Each agency will provide assistance upon request to support compliance activities and litigation by
        the other Agency in cases involving liquid chemical germicides that are intended for use on devices
        Assistance  will be requested in accordance  with applicable procedures, statutory and regulatory
      - requirements including compliance with regulations of 21 CFR Part 20, through the liaison officers
        listed below. Assistance may include provision of sampling, inspection and audit data  exoert
        witnesses, certified statements, and affidavits.                                         '

        Each  Agency may consult with the other at any time to determine if the initiation of regulatory
        and/or enforcement action against a liquid chemical germicide in lieu of or concurrently with the
        other  agency's action is appropriate.

       This Memorandum of Understanding has no effect on any pending investigations or enforcement
       or regulatory actions undertaken by EPA pursuant to FIFRA or by FDA pursuant to the FD&C Act.

C.   Coordination of Activities

To ensure the continued coordinated regulatory, compliance, and enforcement activities for liquid chemical
nfrCFPA'ntep         6T?n deViCeS' an EPA/FDA ^teragency committee is established. The Directors
of the EPA s Registration Division and the Compliance- Division, Office of Prevention Pesticides  aM
Toxic Substances and of FDA's Center for Devices and Radiological Health, Office o? Compute  a^d
SurveiUance  will serve as joint chairpersons who will designate their respective agency members of foe
committee. The committee will meet at a minimum of twice each fiscal year.
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 V.  FUTURE RULEMAKINGS TO ELIMINATE DUPLICATIVE AGENCY REVIEW

 EPA will initiate a rulemaking proceeding under section 25(b) of FIFRA to exempt liquid chemical sterilant
 products from regulation under FIFRA. EPA believes that the efficacy data  requirements and product
 performance standards for liquid chemical sterilants are fulfilled by FDA's section 510(k) requirements or
 premarket approval requirements. When such exemption becomes effective, FDA and EPA will cease to
 follow procedures described hi Paragraph IV,  A. 3. and these  products will be subject solely to the
 regulatory and enforcement requirements and procedures of FDA, and EPA will no longer register such
 products. To the extent EPA receives information regarding such products, it will share such information
 with FDA.

 FDA wilj initiate a rulemaking proceeding to classify liquid chemical germicides used on devices under
 section 513 of the FD&C Act. FDA believes that EPA's requirements under FIFRA for liquid chemical
 germicides that are intended for use on medical devices that are not critical or semicritical devices parallel
 the FD&C Act's requirements under section 510(k) of the Act. Accordingly, FDA will recommend to its
 classification advisory panel that liquid chemical germicides intended for use on devices that are not critical
 or semicritical devices be exempted from premarket notification requirements under section 510(k) of the
 FD&C Act. When any such exemption becomes effective,  FDA and  EPA  will cease  to  follow the
 procedures in paragraph IV. A. 4. To the  extent FDA obtains any information regarding such products,
 it will share the information with EPA.

 VI.  NAME AND ADDRESS OF PARTICIPATING PARTIES

      A.    Food and Drug Administration
             5600 Fishers Lane
             Rockville, MD 20857

      B.    Environmental Protection Agency
             401 M Street, S.W.
             Washington, D.C.  20460

 Vn. LIAISON OFFICERS

      A.    For the Food and Drag Administration

             Sterilization and Toxicology  Project Officer
             (currently:  Dr. Virginia Chamberlain)
             Office of Compliance and Surveillance
             Center  for Devices and Radiological Health
             1390 Piccard Drive
             Rockville, MD 20850
             Telephone: (301)427-1131

For the Environmental Protection Agency:

             Antimicrobial Program Branch Chief
             (currently:  Juanita Wills)
             Registration Division
             Antimicrobial Program Branch (H7505C)
            401 M  Street, S.W.
            Washington, DC  20460
         •   Telephone:  (703) 305-6661
                                                                                      "•

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VIII.  PERIOD OF AGREEMENT

This agreement becomes effective upon acceptance by both parties.  It may be modified by
mutual written consent or terminated by either party upon a thirty (30) day advance written
notice to the other party. The parties agree to evaluate the agreement every three (3) years, at
which time either party would have the  option of renewing, modifying,  or  canceling the
agreement.
              AKO ACCEPTED FOR TK£       APPROVED AND ACCEPTED  FOR THE
    ENVIRONMENTAL PROTECTION AGENC*    FOOD AND D3UG ADKINISTBATIOK
    3*1 tl e Acting Ass^gfaat frlwinfflcrator     Ti Cl e Associate Camssioner for Rggul ato:
    Date   June U~ 1993 _        Date     June 4. 1993
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